S. HRG. 115–102 

HEARING ON THE NOMINATIONS OF MICHAEL 

DOURSON, MATTHEW LEOPOLD, DAVID ROSS, 

AND WILLIAM WEHRUM TO BE ASSISTANT 

ADMINISTRATORS OF THE ENVIRONMENTAL 

PROTECTION AGENCY, AND JEFFERY BARAN 

TO BE A MEMBER OF THE NUCLEAR REGULATORY COMMISSION 

HEARING 

BEFORE THE

COMMITTEE ON 

ENVIRONMENT AND PUBLIC WORKS 

UNITED STATES SENATE 

ONE HUNDRED FIFTEENTH CONGRESS 

FIRST SESSION 

OCTOBER 4, 2017 

Printed for the use of the Committee on Environment and Public Works 

( 

Available via the World Wide Web: http://www.fdsys.gov 

HEARING ON THE NOMINATIONS OF MICHAEL DOURSON, MATTHEW LEOPOLD, DAVID 

THE NUCLEAR REGULATORY COMMISSION RONMENTAL PROTECTION AGENCY, AND JEFFERY BARAN TO BE A MEMBER OF ROSS, AND WILLIAM WEHRUM TO BE ASSISTANT ADMINISTRATORS OF THE ENVIVerDate Aug 31 2005 12:28 Nov 09, 2017 Jkt 000000 PO 00000 Frm 00002 Fmt 6019 Sfmt 6019 S:\_EPW\DOCS\27172.TXT SONYA
U.S. GOVERNMENT PUBLISHING OFFICE

WASHINGTON : 

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27–172 PDF 2017

S. HRG. 115–102 

HEARING ON THE NOMINATIONS OF MICHAEL 

DOURSON, MATTHEW LEOPOLD, DAVID ROSS, 

AND WILLIAM WEHRUM TO BE ASSISTANT 

ADMINISTRATORS OF THE ENVIRONMENTAL 

PROTECTION AGENCY, AND JEFFERY BARAN 

TO BE A MEMBER OF THE NUCLEAR REGULATORY COMMISSION 

HEARING 

BEFORE THE

COMMITTEE ON 

ENVIRONMENT AND PUBLIC WORKS 

UNITED STATES SENATE 

ONE HUNDRED FIFTEENTH CONGRESS 

FIRST SESSION 

OCTOBER 4, 2017 

Printed for the use of the Committee on Environment and Public Works 

( 

Available via the World Wide Web: http://www.fdsys.gov 

(II) 

COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS 

ONE HUNDRED FIFTEENTH CONGRESS 

FIRST SESSION 

JOHN BARRASSO, Wyoming, Chairman 

JAMES M. INHOFE, Oklahoma 

SHELLEY MOORE CAPITO, West Virginia 

JOHN BOOZMAN, Arkansas 

ROGER WICKER, Mississippi 

DEB FISCHER, Nebraska 

JERRY MORAN, Kansas 

MIKE ROUNDS, South Dakota 

JONI ERNST, Iowa 

DAN SULLIVAN, Alaska 

RICHARD SHELBY, Alabama 

THOMAS R. CARPER, Delaware 

BENJAMIN L. CARDIN, Maryland 

BERNARD SANDERS, Vermont 

SHELDON WHITEHOUSE, Rhode Island 

JEFF MERKLEY, Oregon 

KIRSTEN GILLIBRAND, New York 

CORY A. BOOKER, New Jersey 

EDWARD J. MARKEY, Massachusetts 

TAMMY DUCKWORTH, Illinois 

KAMALA HARRIS, California 

RICHARD M. RUSSELL, Majority Staff Director 

GABRIELLE BATKIN, Minority Staff Director 

(III) 

C O N T E N T S 

Page 

OCTOBER 4, 2017 

OPENING STATEMENTS 

Barrasso, Hon. John, U.S. Senator from the State of Wyoming .......................... 1 

Carper, Hon. Thomas R., U.S. Senator from the State of Delaware ................... 3 

Inhofe, Hon. James M., U.S. Senator from the State of Oklahoma .................... 410 

WITNESSES 

Chabot, Hon. Steve J., U.S. Representative from the State of Ohio ................... 410 

Prepared statement .......................................................................................... 412 

Dunn, Hon. Neal P., U.S. Representative from the State of Florida .................. 414 

Prepared statement .......................................................................................... 415 

Dourson, Michael, Professor, Risk Science Center, Department of Environmental Health, University of Cincinnati, College of Medicine ......................... 419 

Prepared statement .......................................................................................... 422 

Response to an additional question from Senator Barrasso ......................... 426 

Responses to additional questions from: 

Senator Carper .......................................................................................... 427 

Senator Booker .......................................................................................... 445 

Response to an additional question from: 

Senator Capito ........................................................................................... 447 

Senator Cardin .......................................................................................... 448 

Responses to additional questions from: 

Senator Duckworth ................................................................................... 449 

Senator Ernst ............................................................................................ 450 

Senator Fischer ......................................................................................... 451 

Senator Markey ......................................................................................... 452 

Senator Merkley ........................................................................................ 454 

Senator Sanders ........................................................................................ 456 

Senator Whitehouse .................................................................................. 460 

Leopold, Matthew, Counsel, Carlton Fields Jordan Burt, P.A. ........................... 478 

Prepared statement .......................................................................................... 480 

Responses to additional questions from: 

Senator Carper .......................................................................................... 484 

Senator Cardin .......................................................................................... 489 

Response to an additional question from Senator Markey ........................... 489 

Responses to additional questions from: 

Senator Sanders ........................................................................................ 490 

Senator Whitehouse .................................................................................. 491 

Ross, David, Assistant Attorney General, State of Wisconsin, and Director, 

Wisconsin Department of Justice Environmental Protection Unit .................. 495 

Prepared statement .......................................................................................... 497 

Responses to additional questions from: 

Senator Carper .......................................................................................... 501 

Senator Booker .......................................................................................... 509 

Senator Cardin .......................................................................................... 510 

Response to an additional question from Senator Ernst ............................... 512 

Responses to additional questions from: 

Senator Markey ......................................................................................... 513 

Senator Sanders ........................................................................................ 514 

Senator Whitehouse .................................................................................. 519 

Wehrum, William, Partner, Hunton & Williams LLP .......................................... 527 

Page

IV 

Wehrum, William, Partner, Hunton & Williams LLP—Continued 

Prepared statement .......................................................................................... 529 

Responses to additional questions from Senator Carper .............................. 532 

Response to an additional question from Senator Cardin ............................ 556 

Responses to additional questions from: 

Senator Duckworth ................................................................................... 557 

Senator Ernst ............................................................................................ 560 

Senator Fischer ......................................................................................... 561 

Senator Markey ......................................................................................... 562 

Senator Merkley ........................................................................................ 563 

Senator Sanders ........................................................................................ 569 

Senator Whitehouse .................................................................................. 572 

Senator Wicker .......................................................................................... 587 

Baran, Jeffery, (Reappointment) Commissioner, U.S. Nuclear Regulatory 

Commission ........................................................................................................... 591 

Prepared statement .......................................................................................... 593 

ADDITIONAL MATERIAL 

Letter to Senators Barrasso and Carper from Audubon Florida, September 

19, 2017 ................................................................................................................. 961 

News Release from the Office of the Administrator, EPA, Widespread Praise 

for Matt Leopold, Leopold Nominated as EPA General Counsel, September 

2, 2017 ................................................................................................................... 962 

News Release from the Office of the Administrator, EPA, Widespread Praise 

From Environmental Officials for David Ross, Ross Nominated to Head 

EPA Office of Water, September 2, 2017 ........................................................... 964 

(1) 

HEARING ON THE NOMINATIONS OF MICHAEL DOURSON, MATTHEW LEOPOLD, 

DAVID ROSS, AND WILLIAM WEHRUM TO BE 

ASSISTANT ADMINISTRATORS OF THE ENVIRONMENTAL PROTECTION AGENCY, AND 

JEFFERY BARAN TO BE A MEMBER OF THE 

NUCLEAR REGULATORY COMMISSION 

WEDNESDAY, OCTOBER 4, 2017 

U.S. SENATE, COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS, Washington, DC. 

The Committee met, pursuant to notice, at 10:03 a.m. in room 

406, Dirksen Senate Office Building, Hon. John Barrasso (Chairman of the Committee) presiding. 

Present: Senators Barrasso, Carper, Inhofe, Capito, Boozman, 

Wicker, Fischer, Rounds, Ernst, Sullivan, Cardin, Whitehouse, 

Merkley, Gillibrand, Booker, Markey, Duckworth, and Harris. 

OPENING STATEMENT OF HON. JOHN BARRASSO, 

U.S. SENATOR FROM THE STATE OF WYOMING 

Senator BARRASSO. Good morning. I call this hearing to order. 

Today we are going to be considering the nomination of four individuals to serve as Assistant Administrators of the U.S. Environmental Protection Agency and one individual to serve as a member 

of the Nuclear Regulatory Commission, the NRC. 

First, I am going to address the four nominees before us today 

to be Assistant Administrators of the EPA. Each one is a well 

qualified individual who will bring a wealth of experience and expertise to a critically important role in protecting America’s public 

health and safety. I applaud the President’s nomination of such accomplished Americans and dedicated public servants. 

President Trump has nominated Michael Dourson to lead the 

EPA’s Office of Chemical Safety and Pollution Prevention. The Office of Chemical Safety and Pollution Prevention protects the 

American people and the environment from potential risks posed 

by pesticides and toxic chemicals. 

Dr. James Klaunig, who has served on numerous EPA scientific 

advisory panels, stated of Dr. Dourson, ‘‘Dr. Dourson is a leader in 

the field of risk assessment. He has been instrumental in bringing 

scientists of different disciplines and representing different constituents together to address current and future approaches to the 

risks of humans to exogenous chemicals.’’ 

2 

President Trump also nominated Matthew Leopold to lead the 

EPA’s Office of the General Counsel. The Office of General Counsel 

serves as the EPA’s chief legal advisor. John Cruden, former 

Obama Justice Department Assistant Attorney General, said this 

of Mr. Leopold: ‘‘He is committed to the rule of law and can be 

counted on to give sound and candid advice to EPA decisionmakers.’’ 

President Trump nominated David Ross to lead EPA’s Office of 

Water. The Office of Water ensures drinking water is safe. The Office also restores and maintains oceans, watersheds, and their 

aquatic ecosystems to protect human health, to support economic 

and recreational activities, and to provide healthy habitat for fish, 

wildlife, and plants. 

Todd Parfitt, the Director of Wyoming’s Department of Environmental Quality, said this of Mr. Ross. He said, ‘‘Mr. Ross possesses 

the necessary tools to effectively and appropriately oversee EPA’s 

water program in a fair, balanced, and practical way.’’ 

When we get to the witness introductions, I will be introducing 

Mr. Ross and will say more about his accomplishments in the time 

he spent in the State of Wyoming. 

President Trump also nominated William Wehrum to lead the 

EPA’s Office of Air and Radiation. The Office of Air and Radiation 

develops national programs, policies, and regulations for controlling 

air pollution and radiation exposure. Former environmental Obama 

Justice official John Cruden said of Mr. Wehrum, ‘‘I believe he is 

committed to achieving clean air for all citizens and carefully following sound and current science.’’ 

I believe we must act quickly to confirm all these EPA nominees 

so the Agency will be even better prepared to protect human health 

and the environment, enforce our environmental laws, and respond 

effectively when disasters strike. 

It is deeply unfortunate that blind opposition to all of these Administration EPA nominees, including the well respected Susan 

Bodine to be EPA’s Enforcement Chief, has stalled the confirmation 

process. Susan was reported in July and has been held up by the 

minority ever since. 

I want to be clear. The EPA’s Office of Enforcement and Compliance Assurance, the office whose vital mission is to hold polluters 

accountable, is without a confirmed leader. It is without its confirmed leader because the minority feels compelled to block all 

nominees to the EPA, regardless of all the pollution and environmental needs of our communities, including those communities 

struggling to recover from the hurricanes that have ravaged our 

shores. 

A primary complaint of the minority that they cite is that blocking all nominees to the EPA is that the EPA is not being responsive to minority’s oversight requests. The EPA has already sent the 

minority over 2,800 pages in response to its seemingly never ending requests. And I have those responses here. Twenty-eight hundred pages. And these are printed on both sides of the pages 

throughout. Two thousand eight hundred pages in response to its 

seemingly never ending requests of the minority. These from the 

EPA. Claiming the EPA is not responsive as an excuse for not confirming important nominees does not pass the smell test. 

3 

Now, I regret that I can’t strike the same positive note that I 

have for the EPA nominees for the nomination of Jeffery Baran to 

serve on another term as member of the Nuclear Regulatory Commission. Mr. Baran is currently on the NRC and though his term 

does not expire until June 2018, he has been nominated at the request of the Senate Democrats. Senate Democrats have refused to 

advance the nominations of Annie Caputo and David Wright to the 

NRC until Commissioner Baran is confirmed to a new 5-year term. 

Let me be clear. Mr. Baran’s nomination is a big ask. Mr. Baran 

has been nominated for a term that is effectively 3 years longer 

than the term for which Mr. Wright has been nominated and 2 

years longer than the term for which Ms. Caputo has been nominated. If Mr. Baran is confirmed, his term would outlast those of 

all Republican nominees to the NRC, including Chairman Svinicki. 

In December 2014, the last time the Senate confirmed Mr. 

Baran, only one Republican voted in favor of his confirmation. I, 

along with many Republicans on this Committee, have voted 

against his nomination on six separate occasions. Since then Commissioner Baran has given me little reason to reconsider my vote. 

I hope this hearing gives us an opportunity to hear from Commissioner Baran and get more clarity regarding his record at the NRC. 

I will now turn to the Ranking Member for his statement. 

Thank you, Senator Carper. 

OPENING STATEMENT OF HON. THOMAS R. CARPER, 

U.S. SENATOR FROM THE STATE OF DELAWARE 

Senator CARPER. Thanks, Mr. Chairman. 

I want to welcome our witnesses today, our nominees. I want to 

welcome your family members—spouses, parents, children, sistersin-law, brothers-in-law. We are happy that you are here, and we 

thank you for your willingness to share with our country those that 

you love. 

Let me just say our Chairman has stacked up here answers that 

he explains are answers to requests and inquiries that we have 

made on the minority side. Senate Democrats on this Committee 

have sent Mr. Pruitt, the Administrator of the EPA, some 26 letters. To seven of them we have received generally full responses. 

Seven out of 26. 

I have stacked up right here the pages of the responses for the 

other 19 requests, the other 19 requests. I have said more than a 

few times if the shoe were on the other foot, and we had a Democrat in the White House, and we had a Democrat majority in the 

House and the Senate, and the Republicans on this Committee or 

any committee were trying to do oversight and get the kind of responses from EPA and from an Administrator from EPA, you 

would be pulling your hair out, and ours, too. This is just unacceptable. 

I am seen in the Senate, and before that as Governor of Delaware, as a fair and impartial person. I like to work with my Republican colleagues. I have gone to bat for my Republican colleagues 

when we did have a Democrat in the White House and the responses to them and to us were not what I thought they should be. 

But we can do better than that. EPA needs to do better than 

that. They need to show us more progress, and when we do we will 

4 

be happy to move these nominations forward. I don’t think that is 

asking too much. 

And with respect to the nomination of Jeff Baran to serve another term on the Nuclear Regulatory Commission, if he is confirmed, I hope that he will be, there will be—get this—three Republicans on the Nuclear Regulatory Commission—three—and 

there will be two Democrats. And they are all good nominees, and 

I look forward to supporting them all. 

Having said that, fast forward to the present to today’s hearing. 

We are 4 days into the new fiscal year and our EPA Administrator, 

Scott Pruitt, has yet to appear before this Committee to discuss 

EPA’s proposed budget. Since Mr. Pruitt was confirmed, I mentioned a number of letters that we submitted and the responses 

that we have gotten, or not gotten. 

Let me just say the idea that we are 9 months into a new Administration, an Administration that has proposed deep cuts in the 

budget for EPA, deep cuts to the number of people who work there, 

deep cuts to the programmatic support of clean water, clean air, 

cleanups for brownfields, hazardous waste sites, and we have yet 

to see the EPA Administrator sit at this table and talk to us to defend this budget. That is just unheard of. I have never seen anything like this. 

Turning to today’s hearing, we have five nominees before us. For 

the most part, I believe that Presidents, Governors, mayors, and 

other elected CEOs should generally be allowed to assemble their 

leadership teams. As Governor, I used to say to the legislature, I 

have been elected to serve as Governor of our State; allow me to 

at least nominate the people that I think would enable me to serve 

well, and they did. And that is why I find it hard, though, I have 

always tried to find a way to support Democrat or Republic administrations with their nominees, and I am certainly trying to do that 

in this Administration, too. They don’t always make it easy. They 

don’t always make it easy. 

But I have some serious and unresolved concerns with two of our 

nominees today. The majority of our nominees I expect to support, 

but two I am troubled by, and I know a number of my colleagues 

are as well. 

Just over a year ago members of this Committee celebrated a 

rare bipartisan achievement when Congress almost unanimously 

enacted comprehensive reform of the Toxic Substances Control Act. 

Jim Inhofe provided great leadership. Others on this Committee 

did as well. From Jim Inhofe all the way to Ed Markey, that covers 

a pretty broad spectrum here. 

And we are trying to get that legislation implemented now, and 

all of us want to see it implemented well. And it was enacted because of a decades old lawsuit that made it all but impossible for 

EPA to otherwise regulate some of the most dangerous chemicals 

known to humankind. And we all share a strong bipartisan interest 

in seeing the new law implemented in an impartial, credible, and 

responsible way. 

Regrettably, I am concerned that Dr. Dourson is not the leader 

that we need for that job. Never in the history of the EPA has a 

nominee to lead the Chemical Safety Office had such deep ties to 

industry. Never has a nominee had such a long record of recomVerDate Aug 31 2005 12:28 Nov 09, 2017 Jkt 000000 PO 00000 Frm 00010 Fmt 6633 Sfmt 6633 S:\_EPW\DOCS\27172.TXT SONYA
5 

mending chemical safety standards that are as much as thousands 

of times less protective, thousands of times less protective than 

those recommended by regulators. Never has a nominee, to my 

knowledge, so consistently underestimated the risks of chemical exposures to the most vulnerable among us. 

And I would like to recognize the presence of a number of people 

who are here in this hearing today who have suffered greatly due 

to exposure to harmful chemicals. These people traveled all the 

way from across the country to be here today. I am not going to 

ask them to stand, but we know you are here. We appreciate your 

presence. 

Having said that, Dr. Dourson did make a good faith effort to respond to a number of the prehearing questions that I sent him and 

others sent to him. That is the good news. 

Now, Mr. Chairman, I ask unanimous consent to place those materials in the record. 

Senator BARRASSO. Without objection. 

[The referenced information follows:] 

6 


27172.001

August 4, 2017 

Dr. Michael L. Dourson 

University of Cincinnati. Colle g.:: of M(!dicinc 

160 Panzeca Way 

Cincinnati. 0!145267~0(}56 

Dear Dr. Dourson: 

The Senate Environment and Public Works Committee has received your nomination to serve as 

the Assistant Administrator of the Office of Chemical Safety and Pollution Prevention at the 

Environmental Protection Agency (EPA). Your record is extensive, particularly your work with 

the Toxicology Excellence for Risk Asscssm.:nt (TERA) that you founded 1

• So the Committee 

can more fully assess your record, I request that you provide the liJl!owing supplemental 

materials and responses to questions prior to the Committee's hearing on your nomination. 

1) Please provide copies of the 2014,2015 and 2016 annual reports for TERA, as the last 

publicly available report on the TERA website is from 20131 

2) TERA's website states that '·TERA provides significant pro bono support to local and 

state governments, NGOS and others to help them address important human health and 

risk issues3 " For each of the past ten years, please list a) the name of each entity to 

whom TERA provided such support and the duration of such et1brts. b) the purpose of 

such support, and c) copies of any documents, presentations or other work products that 

were provided to the entity as part of such support 

3) TERA ·s website statcs that ·'We are transparent about who our funders are and what role 

they had, ifuny. in commenting on the TERA scientific opinions or results." Specific 

information necessary to determine TER1\ 's transparency about this funding is neither 

included in tlw materials that were provided to the Committee nor avai lablc in either the 

publicly available annual reports tilr TERA or on the TERJ\ websitc(s)4• For each of the 

past ten years. please provide a list that names each entity that provided grant, contract or 

other tlnancial support to TERA (or directly to you). the amount and type of such 

funding, the pllrposc(s) 1(11' which it was provided and a specific description (name of 

1 l'or purposes of this letter, references to TERA include its successor entity, the Risk Sdencc Center 

: http://\VW\v.tcra.org/ahout!Annua\Repons.htraf 

http;i/w\vW. tera.org/about/ miss ion··~ history .htrn l 

~ https:I/m~d.uc.cdu/eh/ccntcrslrsc/about-us/funding 
7 


27172.002

research publication, expert testimony, or white paper, etc.) of any outcome developed or 

provided as a result of such funding. 

4) TERA's website states that 'TERA can provide a variety of litigation suppo11 services 

ti·om review and analysis of data, to written opinions, to expert witness testimony" and 

that this work has included ''testimony as expert witness on U.S. EPA's chromium risk 

assessment for Defendant in groundwater contamination case.·· For each of the past ten 

years, please identify each case in which TERA or any of its employees provided 

'litigation support' and the party to which such support was provided, and the amount and 

type of compensation received. !n responding, please include the caption of the case, the 

court in which the case was heard and the case number, and include copies of all 

materials produced as part or its litigation support services, including expert witness 

testimony, analysis or data and written opinions provided by TERA or any of its 

employees. as well as transcripts of depositions of TERA or any of its employees. 

5) TERA ·s website states that '·TERi\ 's work organizing peer input, peer consultation and 

peer review is intended to meet the needs of public and private sponsors who have 

dew loped risk assessment documentation." For each of the past ten years. please provide 

a) a list naming and describing the purpose of each peer input, peer consultation or peer 

review activity conducted by TERA. b) the cntity(ics) that provided the funding for the 

peer activity and the amount of such runding. and c) a list of the individuals who 

participated in the peer activity, along with who chaired the project ;:md which individuals 

were paid for their participation by TERA or the funding party. 

6) The CV you provided to the Committee lists do<:ens of invited presentations you 

delivered. Please provide copies of the slides, speech or other briefing materials tor the 

presentations given on the following dates: June 14, 2017. March 21, 2017, March 14, 

20!7. March 14. 2016. June 24,2015. April20, 2015, January 21, 2015. November 18, 

2010, ;-.;ovcmbcr 4, 2010, December 3, 2004, September 29,2003, September 26,2003, 

July 25. 2002. and April 30, 1996. 

7) The Public Financial Disclosure Report that was provided to the Committee indicates that 

you served as a member of the North American Flame Retardunt Alliance (NAFRA) until 

June 2017. and lists that entity as a non-profit. According to its website5, that entity ·'was 

li.>rmcd in March 201! to serve as the lead advocacy organization in North America for 

!lame retardant producers and users'' Does N AFRA receive any funding from any entity 

that is not itself a manufacturer, user, distributor of or trade association i(Jr flame 

retardant chemicals'' If so, for each of the past two years, please list each such entity and 

the amount of funding it provided to NAFRA. 

5 https://tlamcrctardants.amer!canchcmistry.com/About·North-Americnn~Flamc .. Rctardant"A!Jiancc-NAFRA-/ 
8 


27172.003

R) The Public Financial Disclosure Repo11that was provided to the Committee indicates that 

you serve as the l'rc.<;ident of the Toxicology Education Foundation, and lists that entity 

as a non-prollt. For each of the past two years. please provide a) a list naming each 

corporate entity or industry trade association that provided funding to the Foundation, 

along with the amount oft he funding and b) the total amount of funding provided to the 

Foundation. 

9) The Public Financial Disclosure Report that was provided to the Committee indicates that 

you served as the Secretary of the Toxicology Forum until.lune 2017, and lists that entity 

as a non-pro lit. That entity's website does not list any non-corporate sponsors(' Docs 

the Toxicology Forum receive any funding !l-orn any entity that is not a corporation or 

trade association representing corporations? If so. for each of the past two years, please 

list ~ach such entity and the amount of funding it provided to the Toxicology Forum. 

l 0) Your Ethics Agreement states that "I will not participate personally and substantially in 

any particular matter in which I know that I have a financial interest directly and 

predictably alkctcd by the matter, or in which l know that a person whose interests are 

imputed to me has a financial interest directly and predictably affected by the matter, 

unless I first obtain a written waiver. pursuant to 18 C.S,C. § 208(b)(l), or qualify for a 

regulatory exemption, pursuant to 18 U.S.C. § 208(b)(2)." Please provide a list of 

persons and particular matters (including a list of specific chemical substances, 

pesticides. regulations, regulatory decisions, risk evaluations, assessments or 

dcterminatinns, or topics) about which you plan to consult with the Designated Agency 

Ethics Onicia! in order to determine whether you will recuse yourself or require a written 

exemption or waiver prior to your participation. 

1!) Your Fthics Agreement states that ·'Upon confirmation, I will rC'sign fi·om my positions 

with the t()llowing entities: University of Cincinnati, and the Toxicology Education 

Foundation. I resigned l!·orn my position with the North American Flame Retardant 

Alliance, and the Toxicology Forum in June 2017. For a period of one year after my 

resignation ti·mn each of these entities, I will not participate personally and substantially 

in any particular matter involving spccilic parties in which I know that entity is a party or 

represents a party. unless I am first authorized to pat1icipatc, pursuant to 5 C.F.R. § 

2635.502(d).'' Please provide a list of particular malters involving spcciflc parties 

(including a list of specific chemical substances, pesticides, regulations, regulatory 

decisions, risk evaluations, assessments or determinations, or topics) about which you 

plan to consult with the Designated Agency Ethics Otlicial in order to determine whether 

you will recuse yourself or require advance authorization prior to your participation. 

1

' http:.: dhtltJgue.toxibrum.Qrg/page:bccomc-a-sponsor 
9 


27172.004

12) Your Ethics Agreement also states that you will sign the Trump Ethics Pledgc 7 The 

Trump Ethics Pledge stales "I will not for a period of 2 years from the date of 

my appointment participate in any particular matter involving specific parties that is 

directly and substantially related to my former employer or former clients, including 

regulations and contracts." The Pledge additionally notes that (d) "Directly and 

substantially related to my former employer or former clients" shall mean matters in 

which the appointee's former employer or a former client is a party or represents a 

party" and (i) "Former client" is any person for whom the appointee served personally 

as agent. attorney, or consultant within the 2 years prior to the date of his or her 

appointment, but ~xcluding instances where the service provided was limited to 

a speech or similar appearance. It does not include clients of the appointee's former 

employer to whom the appointee did not personally provide services.'' Please provide a 

list of particular matters involving specific pmiics (including a list of spccit!c chemical 

substances, pesticides, regulations, regulatory decisions, risk evaluations. assessments or 

determinations. or topics) that you plan to recuse yourself from participating in for 2 

years. !fyou plan to request waivers from the Trump Ethics Pledge for 1my such matter. 

please also list those. 

With best personal regards, I am. 

Sincerely yours. 

1 https::';\v\VW. whitchousecgov.rthc~press-office/20 I 7 IO I /28/exccutivc-ordcr-ethics-comrnitments~executivc~hnmch~ 

appointees 
10 


27172.005

UNIVERSITY OF 

Cincinnati 

D~ar Senator Carper 

Risk Science Center 

l)t.:par!ml'nt or l·:m·iro11!!l('!ital llea!th 

l 'nin-r:;it) of Cincinnati l 'ol!q:_e of 

\kdiclnt• 

PO B0:\ 6 700:"6 

t'incinnali, Ohio .f)267-0056 

I 60 Pallll'C<! \\'a; 

Kl:H<-'ring LnM Building. Suit~ (i-24 

hnp: mcd.w.:.edu eh 'CL'nkr-.. lt~ra 

September 6'". 2017 

I appreciate your interest in Toxicology Excelknc~ for Risk .-\sscssmcnt (TFR!\). As youma' 

know. TERA is a nonprollt 50lc3 organization with a mission to support the protection ofpuhlic 

health by developing. n.:YIL'\\ing and communicating risk assessment values and analyses: 

impnwing risk methods through research: and. educating risk assessors. managers. and the 

public on risk assessment issues. TERA was l(mndcJ on the belief that an imkpcndent nonprolit organization can prnvidc a unique function to protect human health by conducting 

scientific research and development on risk issues in a transparent and collahorativc litshion. 

One-third ofTERA 's effort has been J(,r inJustr): 2/3nb of its cfl(m ha:; hcen ll>r govemmcnt. 

In 21 years as an independent and science neutral group. TER;\ published numc·rous report>. 

manuscripts. presentations and education courses. created 5 freely accessible wcbsites. and 

garnered the sponsorship of over 50 gowrnment groups anu as man) industry and nonprotit 

organizatinn:i. \V~: were otlcn thl.! go·to group fix govcrnmcnt~industry collaborations such as 

the pcrchlorutc research program in the late: 1990s. the \Vest Virginia I'FO:\ contamination in the 

early 2000's. and FPA's Voluntary Children's Chemical Evaluation Program in the mid 200(l's. 

TFR;\ also conducted the independent peer review of the 9-gon:rnmcnt report on the wnrld trade 

cc'Jlter disaster and the recent Elk River spill in \\'est Virginia. TFRi\ has recci,·ed many 

accolades anJ hundr~ds of scientists and manau~rs ti·om bllth government and induslrv can aHc.•;t 

to its independent and science-neutral approacl;. Even staff ol: NRDC has cnnuncntccl pri1atdy 

that TLRA wcbsites were 1·isited ol\en sinec thcv contained so much valuabh: inl(mnation. 

Please lind attached responses to you questions. including a disk of related inl(mnation. I would 

he more than happy to nnsw~.:r additional (jlll'stions tl·om : .. ou or your hard-\' 0rking start~ cith~r 

he fore or alter the tcntatiwly scheduled committee meeting later this month. 

Cheers' 

:vlichad L. D<,urson. Ph.D .. Di\llT. FATS. !'SRi\ 

Professor of Em·ironmental llcalth 

An affmnMtve action/equal opporwmty mstliution 
11 


27172.006

\1icha.:l L. Duursnn. Ph.D .. DABT. FAI S. FSRA 

Rcspnmt~s lu Thomas Carprr letter In \lichacl Dunrsun dated Au:.;tL'I -1. :w 17 

()ue:<ti<'!l 1 ' l'ku'v prn1 ide en pi..:> :o l-+. I~ ;md ~,, i '' dllllU:d rc:porh t\>r II.!{ \. 

~~:--: th~· Lbl ~1lbhk· rcpnn \1J1 !lh.: l R \ \\cb..:ik' i-.; ! 3. 

Re,;pon~c: . \nnual rcpmb !(>r ::o l-1 ;llld ::o 1.' :lrc· no\1 a1 :til;!hk <lll !he Tl R.\ 

"cb,;itc· ;;,; 11cll '' tin:m.:i;d >llllllllar: l\1r _"0 I :'i. I hc'>L' 1110 ;mnu:Jin:pt>rl~ 11 itli 

linam:iai summ;trie:-, :ll\: :d:;" :tl\:ichc·d. 

(Ju..:stiun '1 II 1\.\·, \\ch,ik' :>Ulc':< th;;t "j i I(\ pr(ll ide> si~nilicam pn' hm•• supptH'll<> 

loe<tl and :<lii\c: ~"'' cTl111lcl1ts. :-.,( i( lS :ll:d <'lh ... -rs ll' IKip !hc·m <iddrc:-,, hum:n: 

hc·alth :me! risk is,;uc:-, h1r t\!l;il ni'thc· i'"'! tc:n \c;;r,. li,-t :u :h~ n;mw >.>I 

c:ntit1 tn \\hom I i·R.\ pnni,kd •tuch 'lll'i'"n :md the· duralinn <d :'tid! c·n;'ri>. hi 

purpu~~..:· nf ,~u~h -:UJ"lJ'I.lrt. and\.;) of an:. docun1L'l1h. P\lh.'r \\,)!l 

producb th~lt \\c'l\: !'~'"' id-:,ltu the· ,·n1i11 :i' p:n I nl' ·.urh 'UPI'"r' 

Rc:-;pl)11_')~..,~: Pka.s..: :-:~..·e th ... " 11:--.! ,_,r lu:ur,... ~~1r p!'\l hnnP. 

thL· )'-::tr:--. l'ltf." h'l ~:oi5. J h'--·~'-· hour~\\\.'!\.~ dL'\1)\i.:d iP L'ilhl'r: 

• 

l'<trlicipaliclll in -;cicmilic 

\1!1pa~c~7~ 

tSt:tll' II-! .Pl proc:r:un---

-'~'''-~~-'''"'''--'L'~"-.!..!:!.!..!..'.:!.!""~'-'·'"' I I iJ j c I; j-; l'UlTClll J \ h: i il ~: 

• ( ·orpunHl' scic!1l'l' d~..~\ i..:lnpnh..·nt-~~1.:'.~ .. \\ ~Hk \ )n Jl\)t 1. 'lh\.''1'\\ i:-:c 

l'uncbl. ':Udt :r~ the· 2PH.f puhiicalion h) Str:l""'lll'l :d. :>n pc:n:hi<H':ik'. 

and 

• \li:;cc·il:mc:nus <!ll>:II.C!'illtl tll.p!Junc c·:J!b :md lltba gcnc'i~lil) quick c'l1Hlil 

r~spnn:-\l.'\ tn the public 

i)~taikd r~conb \llthi:: :H:ti 1 il.' 11 ere· maintainc:d h: ithlil idual Tl R. \ -;t:.:r l(q· 

gt:n~ra1 purpn:-...1..':--; and corpnr~:tc rL(Pn.b t)f "llch ~...:i'l~H'h \\~'1\.: 1111i r~..~l_;_tint·d 

Sc\ eTa I ,,i,·nti!ic publicatiuns rc,ult<:d i'rt'lll :-:uch l.'!'l('n'. :rs ,~c:,aibcd 

in the ack:rOI\ -;c:uinn c<i'tlil: publiL':IIiil!1 ami 11\diLtbk un nne· or ill(li'C: 

,11· nur \\ L'h:--.it~~. 

Qw.:stion .~ J 1·1 · R \ '> \\\.'l.1sltc ~t~~k·-, that 1.: ~1rc tr;uhj'l~tl\:nt abuu; \\ hu 

~tnd \\h~li l\"rh.• h<h.L if~tn;. in l.'d\11ll1'"''t1iin~ PH t1k' l'FR.\ ~~,.:Jct:iili\..' 

!-.. ... ·~uh:-.." \j"L'ci:il' i;;!(\nnat!t"l1 n .... ·1..~l·-.;~~1r: tu lkh:nninc !TJ(~\\ tr~m:--.p~ll\,'Jh.:: ;ll.,i'Ut thi>.:. 

ttmdin;_: i~ n:.:illh.'r :ndut..k·d in tlh: ;n~n...._-ri:tl~; tktt \\~,:r·~· pr\1' ;~_.k·~.~ th"'· ( dllPnil~c~.: t'lliJ' 

:r' :~i !:1hk ill .:itllc·• til-: ;t\ ;;i l:!bk ,m:w:i! : c'JW!'!S ll R. \ , •r •li: !!>,' I I R,\ 

\\ ~._'h-.;ih.'l .-.: J ~..·~h,·h 1. 1( llk' !'<LSi t-.:n ; ph..· a-.::: pr~n id ... : ;r !l< th.tt n~mh.':; ·.:~h.:h tll:ll 

prrn i:kd (~r:mt. c'Plltract Pi' uthc·r Jin:mc·i,d suppcn·t ll' II K \ wr dirrc·t!) \II:- oul. the· 

;1!1lt>Ulll and t; p..: "~''licit the !'lll'P""cl "l iiJl' "lli,:h it '"" pnn ickd lie 

t nrmh: ,,f I I'C''c'Hn.:h publication. c·xpert ~~-'limon\. 11 hitc p:rpcr. c'k.! n!' all\ 

outcome· dc·1 c'lt'l'l'd Ill' pre'\ ickd :1 rc,ull o:' ::uclt 

9/11/17 1 
12 


27172.007

~v1ichacl L Dourson. Ph.D .. DABT. FATS. FSR:\ 

Rc:-:pnn~~..·: ! l.R.\·s \\urk i"' ~nh.l '->l'lcncL-ncutr~d. ln 'lt..1!lll.' \.:tL'-''--'"· 

1·J·J~.·\ ~d)u\\> . .'d Sl.~{~..-•nti!ic l:t~l11lll\..'1HS J't\1111 ib ;..j10l1'-.l)J'·~ \ill dr:1f't \\Ul'k fH\ldlk'h. 

I hL'-'L' ~Pnlln( .. :nt-... il' an~. \\l'r1..· ~_'lH1.~id;..'l\.'d during 1hc ink'rllid ~1:--"Ul'i.Hh.:~...-· 

1\C\ k\\ pri<>r ftl tll1\ rc'l'''rL In all case~. thc lintd rc'!"'rl rci1c•c·tcd lhc 

opiniPll'-. of'thL' ll.f(\ \~:il.'!1(j-...f:.,, :md fl0ll1Cl.'\..'~~<ll'ii;. t!h\'v._; o(th.._• 'ipOH:-ll1L ,\!}of 

thc I LR.\ rcpon:-- inc·ludcd In \>til' ":ic•miilc 

fnr LPIHrtl\ ~,.-r, .. ~ial or uncertain "'L'i~·nti!i~..· Lk·~l~i"''b \\hL·n \\V 

nr t\~>ulb 1\l't\: ill c>dcb "ith II hit! 'i'''thPh ma: htlll.' d,•,irc·,l. II· 

~~~--T~..,'plin12 ::nd 

~''-~'"' :.·~.==··="-' 

ll R.\ maint;tins a dncumcnt rctcnti,m P''liey ,,1· 7: <:arc; J(,r lik': \I ith iltl' 

c:\t:eptinn "r th<LSc' in1 nh.:d 11 ith ,_:(J(>rt,;. 11 hi::h arc' rc·taincd 

Thnc·!(>re. zktail,; ••tiler than ,;umm:Ir' inlimnation 

Ill>\ gcttt·r:tll; a1 :ti Lthlc ! nute. l1<n1 c\ n, that :<\lllll' rq>prts from 111:1; be 

t'uund ''ntik' l!IZ.\ 1\c'h paflc'L .\ <Hmman oi'thc· t:.\l('n! ••i'cithc·r flOic'r1li11Clll •>r 

11 Pr!-. c:m b,: fllund :ll: 

in .2(110. this .;um111:1n ir1t'unn::liill1 :d"' included a li.'t lli'thnsc· 

>potbt~l'' tl::il re't'rc-;c•ntcd :1 .2" .. ,,r grc;Jkr pan ,,f ll.lt\'.; c:i'l\>n.; ,;,r that 'c':tr. 

·\ Ji,t ufspnn:<nrs :md ih>nl Januar; ~!l]ll June· ::'01:' 1 :liT 

:!lt:tchcd. l·n>:n.lttl; 201.' In ih'''· Ill~ .. \·, ,,,,rf.. Ju, hcc·n minimal :1> the• 

L'OJT'Pr:Hitm '' inds du\\!1. }-Ill' inr~~n:wli\>ll th1.-· ~pnn;-;~_)r~ durin~ til!"' 

\\ind-dn1111 pha,,·.plc·ilsc• eon!:lc'l llr. l'atricia \!ctii1111it •. the· :1crins l'rc,ltknt ti'r 

I I \l'c•llcncc· fur l<i~ok .·\",'''mcnt \ rJ K\1 at: 11 tcra.t>rs. 

:\ut all 111' l Ll\\', 11ork rc,;ultt:d in <'I' <>thc'l' immdi~Hd: tl1:1ibhk 

public inl(mn:Hi,,n. ForL"\aillpk.lll:!lll nl'thc· t;t,L d"n,;l(,r hn1h 1,l<llc'rl1illl211i 

illld indtbli\ spPnsnrs rc~oultc•d in l'cj'<llb ckli1 l.'l\:d li! the sp,lllS<'r that \\ere' 

suhscqucnth u>nl hy or suhmit!c'd hl tt !..'"' l'l'llilKnt I he 

immc·di~ttcl; :11 ailahk inl(>mlttlir>n is posted Pr nokcl on ll·lt \ ·.; 1\c'hsik. 

!'rc'sctl!ati,,ns made· <'11 ll·R\'.; lwrl-. 111<1) nut h:11c ai\\11'.' l'c'Cil rctaincd in the 

liks. and th•''" m;t,k at ,;,·icntilic 

lllc-ctinb!:-- bL·:t.)nd the 7~~Cllr !\.'"tent inn pu!ic:, 

lhc spccilk type uft:ompcns:ilinn h not listed intltc at!:tchmclll~o. hut lTR.\ llll'i 

pritnnrii) pllid COlllr~H:h. \\ ith 'lOll h.' g1n ~.:rmncnt ~ran1:-;. and pri\ ak ~~i ft 

il'th.T>. -\:.: twt<:d :thmc·. if the 1\Prk c'\Cc'c~dc•d 2'', nlll:l(.\'s cllcr:dlc!'l<>n in an: 

um: 1 c'IIL the' sj'(>ih<'l' is lislc'd on the' <lll-lith: linatKial 'lllllllt:trics. 

SL'rYi('l';-\ ffi)!11 r..:\ i~·\\. Jnd ~.is llf tbta to t'iU~n lo l,.'\!X:n \\ iinc:-.:·; 

., ;mci !htlt !hi;-; 1\Pi'k h:to itKiuded "~<>·linlllll\ ,1, c'\j'c.'l'i \lillie''' !ln l .S, l P\'.; 

1 In July 20 I 5. I and mo,;t oft he TEKA staffjoincd the l inil er,;ity of Cincinnati. l\)llcgc of 

Mcdkine 

9/11/17 2 
13 


27172.008

.'v1ichae! L. Dnurson. Ph.D .. D:\HT. FATS. !:SRi\ 

chrntnitun ri:..;l <.i~~t.':...~nh.'lH fpr l)L~fJ...~ndan1 in ;.'roUlhJ\\:th·r t.,'lfl!t~lnlindtillll L:to..;.._-_·· f·, '...\H.:h 

l)rth~ pa-.t ten >~'~Jr~, pk~hL' idem if: l:~to..:h ~..::1>'"' in \\hi1.:h !Tit\ nr :m;. ,,fits clnphr:~..~c:-. 

f1r<\\ idcd 'liti:2atic'n suppnn' :illd thc· part; to 11hic'h :;:JC·h ,upp<H'! '':1, pn11 idc:d. and th<.: 

an1oun1 and lYP'-' ni"cPn1p(·nsmiPn 1 ...... \:._·iYcd in i;klth.h.: tht: tl! 

the La:'l'. the 1,.'11Ur~ in \\hich !h:..· L·a~J..: 11L·ard ;_tnd tl~;.: casL: nun1h.:r. and inc!ud-.: -..:~1pil·s 

elf :illmall'rials pn>duced <!'. p:trt of ils suppnrt .'<'1'1 icc:.:. C\j'.:rl "it ness 

t~;-;tirn~)n~. anaJ:·:~i~ ~c•(d:tla ~1nd \\riltt:.'n ;lpiniun--JWlJ\·ilkd h;. l R.\ ~~r ll!i) <,rih 

1{1,.':--pun,...;L~: Pk>~t~~..· ~l>L' llh.' t~thk bdo\\~ 1\~ql!l. .. '"l~ (or ~:~.,•ttti!~ l'fdtc n1atcri~d:-:. and 

npininn:-: ;.;hou!d hL' dir-..'L'tt.'d to !ltt_· ::.l.i,~.:n ~~nHacL I .,nn tnh:t_Tl;lin ~~!'the L'\i·ain~: 

~t~illl:-. nt.tlh; liti~~Hion. i-.. lh'lli:-:k'll. btll !J'iJ:.._, \\Ol'k \.':\~\..·CdL·d :~~~t: 

llf I LR\'s clli>l'l in e~n: ntw h':lr li·om =(II 0 t•> ::o I'· it ":!' b~c·d c>n til.: lin,mcd 

~U!llllLll'i<...'"> !\'f~'lTL'd ht ~Jlld\1..', 

No. CIY tvtSC 05-01725: 1 regarding comparison 

nf \(.'\'Cis of' COlllalllinant 

, expnsun.~ and health 1 benchmarks. TCE and 

. other soh·ents m:re 

925 9:i5 3300 

Bowles and Vern a l.l.P 

• :2121 N. Califixnia Bini.. 

Suite S75 

P.O. !~ox SlSO 

IN THE St TFR!OR COURT 

OF TilE STATE OF 

CALIFOR\'IA IN AND FOR 

Tl IE COl'NTY OF CONTRA 

COSTA: RON BLOCK. L'l al.. 

PlaintilT: DANir:L !IEUX. ct 

al.. Defendant. 

! involved. 

! 

1 \Valnut Creek. CA 94596-

l SlSO 

t·c;,is.e J\:-~.lic4-3s759·······--· Tk-e·;r~~, (;r~c~~T~(~Iogy 

I SUPERIOR COURT OF TilE i ini(Jrnunion lt1!' 

!STATE OF CALIFORNIA j acrylamidc in cofth:: 

.COUNTY OF !.OS ANGELES. • and potential mixtures 

[CENTRAL CIVIL \VEST: i risk assessment for 

I COLN( 'fl. FOR • \ arious constituents. 

I EDUC.'\TION AND 

f RESEARCH ON TOXICS. a 1 California C\lrporation. acting 

: as a pri vatc atturney general 

in tlw public interest. 

PlaintitT: STJ\Rl3(JCKS 

CORPOR.I\TION. ct a!.. 

Case: BC 3:1761 S 

SUPERIOR COl 'RT OF THE 

STATT: OF CALIFORNIA 

. COUNTY OF LOS 

9/11/17 

Rc,·kw 

I information for 

i acrylamide in french 

: tl·ics and snacks and 

of a No 

Representing the plaintiff. 

'-~~· ···-·"'"~-~-" 

STAFFORD 

(BAR NO. 200950) 

RStaiTord:a mol(l.com 

\!ORRISON & 

FOFRS lTR Ll.P 

-+25 l\larkl:t Street 

San Francisco. Ci\ 

94105-2482 

T.:lcphonr: 

415.268.7000 

Representing the 

dclendants 

3 
14 


27172.009

:'vlichacl 1.. Dourson. Ph.D .. D:\BT. F i\TS. FSR:\ 

~lcDonald"s Cnrporation. 

Defendants 

Significant 

Three publications 

1 resulted: one of them 

· funded by the spon~or. 

The other t110 

pub I icat ions 11·erc 

TI]Zi\ funded. 

Rc•prcsenting the 

dcfendams 

()ucstinn ~) I HC\ :-. ''~hsitc -aatc:s th,u ··I I·.R \\ 11,1r~ peer input. pc:cr 

Lunsultati(_lJJ :1J1d pz.·~..·r 1\.'\ i~,"'\\ i:-- inh.'H(kd 111 ilh.'L't !ht· IKCI..b ~,1fpubJk ~md prl\ak' ~pPl1"'tJr...; 

\\ hn ha1 c d-:1 .:loped risk as:.:c':'Sil1('1i1 docunlcnlatinn." h'r c'nc·h 111' tlk prl>t tc·n \ c':tr,. 

pk·~l~C pnn i~:.k· :1) ~l jj,{ d!1d th;.,• purpo:-;c llf l':h.'h pc·cr input r~t> ... 'r 

CPI1Sttlt:llion •'I' pcc·r n:1 ie11 a..:th it; Ccllldu.:tc·,! h1 11-R·\. hI the: 1 ics i th:H jll\l\ iclcd 

the funding l(>r the peer ac'1:1 ir: ::nd ilk' amo11nt t'f >tKh r111d c 1 a list,,! rile· 

indi1 iduals 111l(l particip:rt.:d in the· pc:cr 11i1h 11ho -:h:tirc'd 1h..: :1nd 

\\hicil indi,iduab \\eTc' p:1id lc11 tiwir h> TI·R,\ ,,r ilK peen\. 

R.:o<pothc': !hi:; information j, ;nrlilabk li>r :illmJiPr pc'c'r rc:' j,,,, ,,r pcc•r 

cun,ultatiun' on TIJ{.\ 11c:hsik at: Less 

ink'lhl' jl('cr r.._·\'it:\\ \arc doth .. ' l'lw gt n ;,.TnJnt'nL 

b~1-.;i~ ~md an.: ~..k'~crih~~,J In l\.'.~J1dl1"l' tu qth:,tion ·' ab\n t'. ( t1!1tpcn··<1l1t)n i-.; nnt 

li.;tl'd. hut if the· \Iori; C\Cc'c'Lkd '",, ,,( 11·1(\'s l'lfml in :111\Pill' \c";lr ll'Pil\ 20111 h' 

.~OJ~. it \\~l:-- ii:-.t1.:d on lh(' tin~mci~ll :-.Ul1111l:lrll':-. r..:!~·rr~.:d 111 :1\"0\l:, 

()Uc''linn (I) I hl' 1·\ _lUll prt>\ idcd 1<1 1hc ( ,,,nunit~~:c lists d<lc:Cil'· ufim itcd 

) PU ~..k·li\crvd, Pk·~h1,' pnn ide copi,__--~ \"J'th~..~ >!ides. ;)P\.''-',;h nr l~th;.·r bri~.·!in~ nlak·rial:::; ltl: 

tlw <'~1 '''' :lw f,,jJ"''ill;! d:tlC< June: I 201 \hrch 'I. ::oJ 7. \brei! 1-L 

j(l_JunL·~:-+ "'(Jl5. 2U1~.J:.muar\ "'l. !~. :.~(J\Cn1htT !X. 

20 Ill. lkcc·mbt:r 3. ~00.1. ~,·ptcmhcT .~'.J. 200:;. ~,·ph:mkr 2~> . . )111.1. 

''. 20il.:'. ;m.l .\pril ~U. j<l<)(>. 

l~c,pc>n'c: I 'he: titk,; ;md tor<> up,;[,, 11 hkh I arc shc>wn 

b~..·hl\\ l'hl' prL':-.cntatiP!h ~Ire att:tdh:d. ~..·xcL'pt the b~t one.\\ hich C<!llnnt ht· 

lu<:alc'cL 

'"I kalth risk assessment fur pcrch!(lrate: ~cw direction in EPA's modeling 

approach for cstahlishing standards'" American \:Vater \:Vorks Association. 

Annual Cont;;rencc. l'hiladdphia. Pi\. June !cl. 2017. 

Managing the non-cancer risks a hazardous waste sites: Trichloroethylene (TCE} 

as a case study'" Association for Em·ironmcntalllcalth and Sciences (A EllS) 

Foundation. San Diego. Calif'ornia March 21. 2017. 

'"The concept of honnesis and application in risk assessment'" Society of 

Toxicology. Baltimore. Mar\ land. :Vlarch 14. 201 7. 

9/11/17 
15 


27172.010

Michael L. Dourson. Ph.D .. DAilT. !·AI'S. FSR:\ 

··Yes. 'Thrcsboldabk' Carcinllgcns Arc Still Delane: Carcitwgcns" Roumltabk 

Session: Is a "Thrcsholdablc" Carcinogen Still a Delancy Carcinogen? Society of 

Toxicolo~·. New Orkans. Louisiana. lvlarch 14. 2016. 

"!)dining the range of the rdcn:m:e dose: imprecision versus uncertainty" The 

TCE Hevolution and its l'ermaucnt Impact on Environmental Due Diligence, 

EDR Insight. National Tdccon!Cn:ncef\Vebinar. June 24. 2015. 

";\ssessmenl and management of Uk River. West Virginia drinking miter 

comamination incident. 2014 .. British Toxicology Society Annual Congress. 

Birmingham. l!K. April 20. 201:'. 

"l'raetkal Cluidancc on the Dcvclopm.:nt of a Non-cancer !Iazard Range !i1r 

Fffecti\·e Risk Assessment and Risk \hmagement of Contaminated Sites: i\ Case 

Study with Trichlorocthyknc and Other Chemicals" Tri-Service Environmental 

Risk Assessment Work Group, Na1al l\kdical Center. Portsmouth. Vi\ . .I an. 21. 

201) 

"Draft Toxicnlogical Re\'iew o!' Hcxa111lcnt Chromium" Environmental 

Protection Agenc~·'s IRIS listening session. \\'ashington. D.C. Novemhcr 1 R. 

:?.OJO. 

"PcrspectiYes of Air Pollutants: l!callh Effects Rescan:h Update Session: Ri>k 

:\ssessmcnt. .. in the:: I"' Centurr" Clean Air Forum. Houston. TX. Ntw. 4. 

2010. . 

"Men.:urv Re!.!ulation: Fishin!.! Fnr The· Facts About Risk" 

States arid N<~tion Policy Sun~mit. American Lcgislatin~ Exchange Cuuneil. 

Washington D.C. December 3. 2004. 

"[ listory of TENA Coordinated Public/l'ri1·atc: Partnership on Perchlorate 

Research" Perchlorate Statc-o!~thc-Scicnce Symposium. University nf 

:"llebraska, Center for En,·ironmcntal Toxicolo~·. Omaha. Nt:braska. 

S.:plcmbcr 29. 2003. 

''Perchlorate Rcfcn.:ncc Dose (RlU)" C:~lifornia Environmental Protection 

Agency. September 26. 200.1. 

--~·lodding Of Population Variability" :vlid\\Cskrn States Risk Assessment 

Symposium. lrulian>~ ncpartmcnt of Environmental Management. 

Indi:mapolis. IN. July 25. 2002. 

"Dose Response Class l:xercis.:: :\rocfor" In: Risk asscssmenL lJnh'ersity of 

Cincinnati, College of Medicilll~. ;\pril 30. l <l%. [presentation wuld not he 

located I 

(_luc·:·aion I he· l'nhlic 1-in:mcL!l Di'·cll•,;urc· Report tbt >l:l'- !'it'' itkd to lhL· ( ·,,mmitl<.'c' 

indicate" that \i>ll '-<.:1"\c'd as member,,( \,,nh .\mc:ic:uJ!·hmc Rc·t:u·danl .\ikt:Kc' 

(\;\I R \I until .lunc :2!!17. amllish tlwt ,·!1lit' :1:: a 

that entity "\\as l(>rm<:d in \L1rc·h .)ill I•> sc·nc 111 

\·~H·th \nh:ricJ: !~1:r llanh~ l'l'ldrt.Llnt pt"ttdth.:~..·r:-. and w,, r;-;. Dol.';-, '' .. \t·l\ \ rL:.,:t.'i\-..' :m: 

9/11/17 5 
16 


27172.011

Michael L. Dourson. Ph.D .. DAB L FA IS. 1-'SRA 

a:-~snt:i~ni\H1 l()r ll~nnt· fl..'!ttrd~nH ch\..·mi\::d'-'.) l( -.n. tt'r nftlh.' p~bl l\\n: 

'< \i '!\ \ . 

li< 

'-'~H:h and th>-' :llll\'tn;: it pr1)\ id •. :d 

. I \\;t:') ~t l11l'lnh.:r ~ll l;;-..· "-.\l !C\ ~...:!c;h .. ·~.,· (·P~111Citk'J..' nn ... l ~l~ 

such \\itS nol pri\: !\) thi:-- inl\n·!n;li~~HL Pk~·!,,.' l'cl..'l rr-._\; tl.' \.'t)J'!\\ll'l I }J'. Kirnhcd~ 

\\'hitc d! k \\ hitc· a .c<llll. 

<.)u~,'...:ti,H1 ~1 l h~_· Puh!l~ I !n:n;\..'i;1l Di~citJ~d!\.' I<.:r·~.~rt thdl \\:1'- r'r\'\ ( 1"~l!l!:1iHc~..· 

indiL:ai-..·...; th:H ;Pu :-<nc the Pr~..·:'lidcnt ~_)!'ilk·: l i·,Ju.:~1\L'l; l·Pwh.Luinn. ,nh1 

il"'t" lh~tt cntit) 11:-- ;t I ur pk'd""'' pnn i.J ... , ,J, !!'"'i 

nm11inb! L':tch •. :or;'lz;r~th..' nr lnd11str: tr:ll.k "1"-.:\\'H.:::t!i~rn th~1t fH\H ilkd 

i"<>UIHbih>!L 1\ J(h tlh: ilii1P!I!ll ill' the 

j'i'l'\ i(kd ln the· I, :uncbtinn, 

I he 

• A1'<11l. 6'9!16. s:;oo 

• i\\011. !21!61!6. $1000 

• Expcrimur. I! 1.1' 17. $2500 

t)uc;-.:ti\)!1 lit lh~..· Public Fin~n1cial Di'-.;.'kl:-:UJ'r..: R\..'pPrt that \\:l:-. pr<'n id._~d l\) th;.-- c-~.~:nn:ith:l· 

lndk~ncs th:lt :t'lu :..,_:n\..·d <t~ ih~.-· S~_·u\.'lJr: ol'l!lc ttr-\it:n\;)~~ /'"l>nun until JunL' .2t!} . :tnd 

li;-.;b tiut en! it~ ~~:-- :1 lh)n~prclliL i hJt 's \\,;h,.:i\1.: dnc:< lh)t li"t <111~ :1~.•n-~..-·dl'f'PLttc 

\rHitl"'-\'r:-;. j)pc-.., thl' ~ l·orum l\.'l'Ci\t' ~!11! ftmdill~1 fn\l)'l ;m:' !hal I)Ol C\ 

t.:orpnr:Jt~tln !r~h.lc ~b,-.;Pcl:Hi~\n lf-..tt. J~1r h ufl.hc P~t:-..t t\\tl 

: cl:·.-;.. pfe~t--l' li'~t .. :~h,'h 'Lh:h :1:hl tht..' ::n:ounl \)f Iundin~: id .. :..\ t' 1 dtL' 

I l''l'lllll. 

Vuc:stinn Hh Your Ethics Agreement states thttt ""I \\ill not participate personally and 

substantially in any particular matter in which I kno\\' that I have a financial interest 

directly and predictably affected by the matter. or in 1\hich I know that a person 11hose 

interests arc imputed to me has a linancial interest directly and pn:dktably affected by 1hc 

matter. unless I !irst obtain a \Hillen wai\'cr. pursuant to IX l :.s.c. § 20X(b)( l ). or qualitY 

for a n:g:ulmory exemption. pursuant to 18 [I.S.C. § 208(h){2)." Pkasc provide a list of 

persons and particular matters (including a list of sp<x:ilic chemical substances. pesticides. 

regulations. regulatory decisions. risk c1 aluations. assessments or determinations. or 

topics) about which you plan to consult with the Designated Agency Fthics Orticial in 

order to determine ll'hcther you will rccuso: yoursdf or rc:quire a 1\'l'itten exemption ell' 

waiYcr prior to participation. 

Response: In connection with the nomination process. l have consuhcd with the 

O!'lice nf (io,·crnmcnt Ethics and the EPA's designated agency ethics onicial to 

identitY potential conllit:ts of interest. Any potential conllicts of interest will he 

resoh cd in accordance with the terms of an c:thics agreement that I have entered 

9/ll/17 6 
17 


27172.012

Micha~l L. Dourson. Ph.D" DABT. FATS. FSRA 

into with the Agency's designated agency ethics oflicial and that has been 

prn\·id~d to this Committee. 

The emiti<.:s fi·om which I C)( peel to he recused under l X L:.s.c. ~:!OS ar~: 

• Dourson, Dnurson and Fowler (unlil such time that the 11nancial interest is 

transfcrr~d) 

• t'v!artha C. Dnurson. l.LC 

()ul·:-;tion ll i Your t:thics Agrc~mcnt stat~s that "Upon conlinnation. I will r~sign from 

my positions with the following entities: University of Cincinnati. and the Toxicology 

Education Foundation. I rcsign~d from my posit inn with the >-lorth American Flame 

Retardant J\lliancc. and the Toxicology Forum in Jum: 2017. For a period of om: ycar 

aftcr my resignation li·om each of these cntitics, I will not participillc personally and 

suhstamially in any particular mattl.!r inmlving spccilic parties in "'hich I kno"' that 

entity is a parry or rcprcsc~nts a party. unkss I am first authorized to participat~. pursuant 

to 5 C.F.R. s 2(,_>5.502(d):· Please proddc a list ofpartictilar matlcrs involving specific 

parties (including a list or specific chemical suhstanccs. pesticides. regulations. 

regulatory decisions. risk C\·aluations. assessmcnls or dctcrrninations. or topics) ahout 

which you plan to consult with the lksignatcd Agency Ethics Official in order to 

determine whcthcr you will r~·cuse yourself or rcquin: advance authorization prior to your 

participation. 

Response: In conncctinn ''ith thc nomination process. I havc o.:onsultcd with the 

Office of ( iovernment Ethics and thc FPXs agency ethics ot1icials to idcntify 

potential impartiality concerns. Any such cnm:crns ''ill be n.:solvcd in aceordanc~ 

with the terms of an ethics agreement that I havc cnlcrccl into with the Agency's 

dc~ignat~d agency cthics oflio.:ial and that has h.:cn provided to this Committee. 

Pursuant to 5 C.F.R. * 2635.502. I .:xp<:ctto be recused from participation in any 

spccilic party particular matter in\\ bkh any or the lblhming is or represents a 

party: 

• llnivcrsity or Cincinnati 

• Tnxic:ology l·:ducation Foundation 

• North ;\m~rican Flame Retardant i\lliam:c 

• lm;io.:ology Forum 

• CrcatcSpao.:~ lndcpcnd~nt Publishing Platform 

• Dnurson. Dourson. and hmkr (for one year l(lllowing the financial 

transli:r) 

• i\11) client of my spouse's !inn, :Vlartha C. Dourson. U.C 

l lu~;-;tion I~ 1 Your Ethics i\crccmcntalso statcs that vou will sign the Trump Ethics 

!;ledge. Thc Trump f;thics l~kdgc states that "I \\ illt;ot l(>r a pc~iod nf 2 years from tho: 

9/ll/17 7 
18 


27172.013

Michael!.. Dourson. Ph.D .. D/\BT. h\TS. FSR/\ 

date of my appointment participate in any particular matter involving specific parties that 

is directly and substantially related to my former employer or former clients. including 

rcgulutions and eontracb." The Pledge additionally notes that (d) "Directly and 

substantially rclat<.'d to my former employer and foml<.T clients" shall mean matters in 

which the appointee· s ltmncr employer or limncr dient is a p<trty or represents a party" 

and (i) "Fonner c!icnf' is any person for whom the appointee sen·cd personally as agc'nt. 

attorney. or consultant 11·ithin the 2 year~ prior to the date of his or her appointment. but 

excluding instances in which the scrl'ic..: provided was limited to a speech or similar 

appearance. It does not include clients of the appointee· s t(mncr employer to whom the 

appointee did not personally prm ide ~erviccs ... Please pnwidc a list of particular matters 

involving specific parties (including a list of specific ch..:mical substances. pesticides. 

regulations. regulatory decisions. risk entlumions. assessments or determinations. or 

topics) that you plan to re<.:usc yourself from participating in li1r 2 years. lfyou plan to 

request waivers tl·om the Trump Ethics Pkdgc li1r any such matter. please also list those. 

Response: In connection with the nomination process. [have consulted with the 

Office of Go\ crnmcnt Ethics and the EPi\ ·s agency ethics oflicials and been 

advised that my fonm:r employer f(Jr tlw past 1 years has been the University of 

Cincinnati. which is a local university. ;\s ~ct !(lrth in Sc..:tion 2(j) of Exccuti\ e 

Order 13.770. the term "fom1er cmpkl)'L'r .. docs not include any State or local 

government. I am advis.:d that. lilr the purposes of the Ethics Pledge. the Orticc 

of Ciovcrnml!nt Ethics has determined that this exclusion ··docs extend to a state 

or local college or unh·crsity .··c Therefore. my only fonner clknt/l(mner 

employer is the Unhwsity of Cincinnati. which is addressed in my ethics 

agreement that has been provided to this Committee. I do not intend to ~cck uny 

waiver from the Trump l·:thics Pledge. 

'Sec Ollicc of'(io' crnment Ethics iOGE). "Ethics !'ledge: Revolving Door Ban·· All 

Appointees Entering (iovcrnmcnt:: [)().()().()II (March '26, 2009). OCiE affirmed in its 

"Guidance onl·:;.;ccuthe Order 13770.'' LA-17-03 (March 20. 2!07) that th.: t.:rnh used in Pledge 

paragmph 2 are applicahlc 10 !'xccutivc Order I 3 770. sec. l. par. 6. 

9/11/17 8 
19 


27172.014

TOXICOLOGY EXCE ENCE 

RI S ASSESSMENT (TERA) 
20 


27172.015

:I, 
21 


27172.016

Mission 

ll' 
22 


27172.017

Vision 

Core Values 

on the.beliefthat an independent 

atiori can pm'{jde a unique function 

health I)¥ cqri'd~cting scientific research 

menton risk f~sues tn a transparent and 

e.fashfon; and C~fnm~nicating these results 

TERA is an independent non-profit and as such we embrace our c~~:pri~cfples Snd vilues 

in all our activities. These core principles guide day~to~day TER1oP~rauOns_"-Ft_r~ qL.,Jr · 

consideration of new projects and sponsors, to our .5~lentJfi; eVaJu~ati_ons anq,·. · .. :: communicationofresults. ·· ".,:'\;,;!·\!" .•.•• : .·· ~· * ~ 

Honesty and integrity 

Independence 

Transparency 

Collaboration 

·:':\:Ji.-')·:·· ::.-

"<·.:7:;;'~ s:~~ 
23 


27172.018

Michael Dourson, PhD 

(perpetual)' 

President 

Toxicology Excellence for Risk 

Assessment 

Gail Charnley Elliott, PhD (2015) 

Health Risk Strategies 

Mike Fremont, PhD (2014) 

Rivers Unlimited 

Jennifer L.S. Knaack, PhD (2015) 

Department of Pharmaceutical 

Sciences 

College of Pharmacy & Health 

Sciences 

Mercer University 

Laurie Kraus, PhD (2016) 

James Rock, PhD [1016) 

Gregery S. Romshe, CMA (2015) 

VICE CHAIR and FINANCE 

COMMITIEE CHAIR 

The Procter & Gamble Company 

Jon L. Seymour, PhD (2014) 

AUDIT COMMITIEE MEMBER 

Martin L. Stephens, PhD (2016) 

Johns Hopkins Center for 

Alternatives to Animal Testing 

Philip E. Tobin, PA·C, MPAS (2016) 

NOMINATING COMMITIEE 

MEMBER 

Department of Physician Assistant 

Studies 

James D. Wilson, PhD (2016) 

CHAIR 

Chase D. Wright, CPA (2016) 

AUDIT COMMITIEE CHAIR 

' Directors Sl:!rve 3 year tNm; date fndl(ates end!ng ye<lr of current teml, 1 ,\o1lchaells an (I'd hoc member of the Board of 

Dlrettors as the President of JIM. 
24 


27172.019

overview 

• Active portfolio 

We currently have overs a active projects with a wide 

range of sponsors in(ludlng gov.ernment, industry, and 

other collaborations 

• SOT 

We have 13 presentations or posters 

Other meetings: TRAC, lSES, SETA(, SR.t\, OTR 

• Collaborative initiatives 

L' Beyond Sdence and Decisions- Alliance for Risk 

Assessment 

::;. Occupational A!!i.ance for Risk Science 

K idschern ica!safety .org 

International toxicity estimates for risk (ITER) 

• Courses across the globe 

lndonesi_;j: SOT Global schol<1r fo!!ow~up training 

!src::~el: planning private courses 
25 


27172.020

\;VV T!l,P Peer Rt~view of the MCHtvi 

Screening Level LiJst winter the people of Ch<Jr!eston 

West Virginia complained of a licorice odor from their 

water. A coal-cleaning chen1k:a!, 1\11CHM1 had spilled from a store~ge tank into the Elk River 

and contaminated the community's water supply. With very limited he-a!th effects data1 the 

Centers for Dise<Jse Control and Prevention (CDC) provided the state with a screening value 

of 1 ppm for 4-methyl-1-cyclohexanemethanol (MCHM). One month ;ofter the spill, 

measorements were belovv the detection limit yet some people could still smell the 

chemical's characteristic licorice odor, leading the Governor of West Virginia to fund an. 

independent group- the \"/est Virginia Testing Assessment Proiect (WV TAP)- to conduct 

research to address the inconsistent results <1nd convene zm independent panel to evaluate 

the health protection of the CDC screening !ev~L 

TERA was ask-ed to organize and convene an independent peer revievv panel to revi-ew the 

available data and determine wh-ether the scr-eening value that the CDC provided the State 

was protedive of pub tic hei:!lth, The TERA panel of five experts (Shai Ezra, Mekorot, !;,rae! 

National Water Company Ltd.i Jomes Jacobus, Minnesota Department of Health; Stephen 

Roberts, University of r!orida; Paul Rumsby, N<1tiona! Cenlrc for Environmental Toxicology 

at WRc pic, UK; and i'v1ichae! in Charleston to review the toxicological 

Hteratur€ and screening values. The Pane! a short-term health advisory of 1:::0 ppb 

for MCHM based on a NOEL of 100 mg/kg~day from a 4 week study (Eastman, 1990 ). This 

study and effe.ct level \Nere the same as that used by CDC for its advisory. However, the 

panel differed from CDC in several regards, including adjusting the experiment<1! dose for 

the five days per vveek dosing regimen and accounting for the public's exposure via other 

routes. 

See http:jfw•.vw.ter~.org/Pe~rjinclex.htr(1! for a copy of the panePs. report. 
26 


27172.021

We are excited ~s this 

This project is 

lobsters by rcvievving 

am:1 evalu(!ting the 

'"'''P<,mlc>r•t of direct ~nd 

,, (TBBP1\) data review and 

!n three papers on TBBPA dquatic 

to Vancouver, British Columbia fo1· the 

Chemistry Meeting (SETAC). TEnA was 

investigated for data on the potential for 

limits; additional data on ecologic<1! 

lnduding presence in 

in other plant species. 

We are pleased to announce our expanded suite of ecological and environmental science 

services, complementing our strong historical reputation in health risk assessment and 

industrial hygiene. Our staff now includes scientists wit/1 broad experience in 

ecotoxicology, en11Jivnmenta/ fate, and ecological risk and hazard assessment of chemical 

ingredients, products and by-products. 

s I -\i' ! l\ 
27 


27172.022

Alliance for Risk Assessment (ARA) 

The Alliance for Risk 1\sst:ssment (f\RA) ls a collaboration of 

diverse organiz<Jtions representing government, ac.adem!c, 

industry, environmental and consulting perspectives, te<'!ming 

to protect public health. Working together, the ARA pools resources 1 information, and 

expertise to address chemical risk assessment issues th<=Jt individual organizations cannot 

resolve on their own. State risk assessors have fanned coalitions within the ARA to develop 

guidance methods, to peer review risk assessments, and to find funding for risk projects. 

Risk Information Exchange (RISKIE) RiskiE contains over 4700 

in-progress hum<Jn health risk <lSSe:ssment projects from 35 organizations 

in 13 countries around the world. RisklE offers a view into the risk science 

work of other organizations, in an effort to bridge communic~tion gaps among risk 

assessors of governn1ent, industry, aGJdemic, and environn1ental organizations. State risk 

assessors can use Risk!E to find soon to be released risk va!ues, "find potential partners on an 

upcoming assessment, or publicize their own risk work. 

State Environmental Agency Collaboration for 

Harmonization (SEARCH) SEARCH is a free online 

interactive too! designed to help create a collaborative 

network among state agencies to aid In efficiently sharing information ;:md resources, zmd to 

work toward the harmonization of risk values used by state agencies. SEARCH Is intended 

to help state risk agencies cornmunic<~te, share information, and co!!<'! borate. 
28 


27172.023

1::;, Jidance for A coalition of organizations was 

;:;:rmed to develop guidance on ho1.v to interpret the non·cancer endpoint 

1en is used for declding dean·up standards or acceptable exposure 

levels when closing sites, using trichloroethylene as a case study. The sought to 

clarify the issues surrounding the potential developmental carrliac for use 

understanding clean up standards and short term exposure levels. A webinar will be held 

this fall to discuss lessons learned and to develop a path forward. State risk assessors 

working in remediation, or slte closure may find the guidance developed by thfs effort 

particularly usefuL 

May 21 and 22 1 :2014 at the Texas Cornrnission on Environmental QuaHty ln Austin, Texas 

The workshop serlt~s, Beyond Science Declsions: From Proh!em Formulation to Dose~ 

Response continues and expands upon the discussion Initiated by the Notional Academy of 

Science report: Science and Decisions: Advvnccment of Risk Assessment (NRC, 2009), 

workshops utilize a multi~st;,keholder format to support the development of a practical and 

solution-oriented compendium of risk assessment methods, Conducted under the aegis of 

the Alliance for Risk Assessment (ARA), the workshop series explores both currently 

available and evolving rnethodologies1 through tht~ development and application of case 

studies. The workshop series based on the fundamental premise thilt the ~ppropriate 

methodologies for dose-response ossessment need to be based on objectives specific to the 

intended application; this will include varying levels of ano:llysis. 

The workshop series continues to advance the framework of ARA (2012) on problem 

formulation and dose-response an.a!ysis (beta version available at 

The purpose of this \Vorkshop report is to doetJm(::nt and cornmunicate- the workshop results 

to the workshop participants and interested others. The report contains summaries of the 

Science Panel discussions with the authors of invited presentations, we!! as the Sdence 

Panel review case ':ltudies presented at the workshop. 
29 


27172.024

The 

Advance 

Pef!t Consultation 

Workshop on the 

R€latlonsh!p between PAC 

ProfHe and T oxiclty of 

Petroleum Substances 
30 


27172.025

Kids + Chemical Safety 

A new feature was added to the web5ite, called 

' 11 l'v1om's Perspectlve. 11 This blogfe<ltures .o;tori-es about the 

rldventures of raising chi!dnm in an -environment surrounded by chemicals. 

We v.Jill report on a v<Jrlety of interesting subje<.ts and mom related facts. 

For example: Did you know it takes approximvte!y 9 hours for the 

"StC'm" of a le<Jf to p<Jss thru the Gl tr.oct of a 3 ye<:~r old? 

Dr. rvlichael Dourson in a live radio 

' 

behalf Kids+Chemical Safety. He spoke about the benefits 

and risks of fluoride in drinking w<~te.r (bdsed on an essay posted 

on KidsChernir;:aiS;;1fety.org) and we!! as general toxicology 

understanding: that a!! chemicals may be toxic !t vvas part of the 

Health, Wealth & Wisdom daily radio show on 1470 .!\;\A, WMGG 

(in the TJrnp Bay, H vrea). 

A visual presentation, along with the radio interview, can be found on our 

website, along with <~rticles on fluoride. 

! :,.>' , rn. 
31 


27172.026

New interf<:~ce to help you find the information vou need, 

Over 90 Concise !nterna.tiona! Chcmka! Ass0ssrnent Documents (C!CADs) fmm the 

World Health org.aninHion (WHO} h.avc heen added to lTER 

\IVith the help of Summit Toxicology, 1TER now incl1.1des Biomonitorlng 

present em entirely new type of content for !1 ER 

users, ;,nd can 

\jf 
32 


27172.027

toxkology for over 28 

speak on uAdvances in Assessing Food Additive 

Safetyu at the SP! Food, Drug and Cosmetic 

P.Jckagfng Materials Comrnittee, Food 

Summit in New Orleans, Louisiana on 

10~12 1 2014. 

a Sodety for Risk Analysts 

Student/New Researcher 

Travel Award to thls year's 

Annual Meeting fn 'Denver, 

Colorado. She will be 

Project thesis and 

publication. 
33 


27172.028
34 


27172.029

Andersen, i'vlE; Preston, RJ; Maier, A; Willis, A; Patterson, J. 2014. Dose-Response Approaches for 

Nuclear Receptor-Mediated Modes of Action for Uver C<Jrcinogenicity: Hesults of a Workshop. Crit 

Hev ToxicoL 44( 1 ):50-63 ( doi:10.3109/10408444-2013.8357Ss). 

Downloads of this and other papers coming out of the nuclear receptor workshop puhlished 

in Critical Reviews in Toxicology are being r:1ade avaibh!e for a limited tirne free of 

charge. Please go to to download a 

copy. The paper on the CAR MOA by Elcombe and as a top 10 risk 

assessment paper published in 1.013 by the Risk Assessment Specialty Section of SOT. 

Budinsky, RA; Schrenk, D; Simon, T; Van den Berg. M; Reichard, JF; Silkworth, JB; Aylward, LL; Brix, A; 

Gasiewkz, T; Kaminski, N; Perdew, G; Starr, TB; Walker, NJ; Rowlands, JC, 2014. Mode of action and 

dose-response frzunework analysis for receptor-mediated toxicity: The aryl hydrocarbon receptor iJS 

a case study. Crit Rev -r oxicol 44( 1 ):83~119 (PMIO; 24245878). 

Chen, J; Hu, Z; Phatak, M; Reichard, J; Freudenb12rg, JM; Sivaganesan, S; Medvedovic, i\1\. 2013. 

Genome-wide signatures of transcription factor activity: connecting transcription factors, disease, 

and sma!l molecules. PLoS Cornput Bioi. !)(9):PMC3764016. 

Dourson, Mj Reichard, J; Nance, P; Bur!eigh-Flayer, H; Parker, A; Vincent, M; McConnell, EE. 2014. 

Mode of Action Analysis for Uwr Tumors from Oral1,4-Dioxane Exposures and Evidence-Based Dose 

Response Assessment. Regu! Toxicol Pharmacal (in press). 

Dourson, M; Becker, RA; Haber, LT; Pottenger, LH: Bredfeldt, T; Fenner-Crisp, r. 2013. Advancing 

Human Health Risk Assessment: Jntegrating Hecent Advisory Committee Recommendations. Crit Rev 

·roxicol. 43(6):467-92 (doi: 10.3109]10408444.201).807223). 

Dourson, M; Gadagbui, 8; Griffin, 5.; Garabr<Jnt, DJL Haws, L.C.; 

The importance of problem formu!utions in 

contaminated soil. Reg Toxico! Pharrnco!. 66(2):?o{Ln6. 

c. 2013. 

Effio, DG; Kroner, 0; Maier! A; Hayes, W; Willis, A; Strawson J.2013. A look J.t State-Level Risk 

Assessment in the United States: Making Decisions in the Absence of Federal Risk Values. Risk 

Analysis. 33(1):54·67. 
35 


27172.030

Hasegawa, R; Hirata-Koizumi, M; Dourson, ML; Parker, A; Ono, A; Hirose, r\. 2013. Safety assessrTH:'>nt 

of boron by application of new uncertainty factors <Jnd their subdivision. Regul T oxicol Pharmacal 

65( 1 ):108-114 ( doi: 10.1016/j.yrtph.wn. 10.013). 

Hertzberg, RC; Pan, Y; Li, R; Haber, LT; lyles, RH; Herr, DW; Moser, VC; Simmons, JE. 2013. A four step 

approach to evaluate mixtures for consistency with dose addition. Toxicology. ( doi: S0)00-

483X( 12)00368-X. 10.1016/j.tox.2012.10.016 ). 

Juberg, DR; Berghoff, SJ; Becker, RA; Casey, W; Hartung, T; Holsapple, MP; Marty, SM; ,\>lihaich, EM; 

VanDer Kraak, G; Wade, MG; \Vi!lett, CE; Andersen, ME; Borgert, CJ; Coady, KK; Dourson, ML; Fowle, 

JR; Gray, LE; Lamb, JC; Ortego, LS; Schug, H; Toole, G;l; Zorri!la, LM; Kroner, OL; Patterson, J; 

Rinckel, LA; Jones, BR. 2014. qworl<shop Report, Lessons learned, Challenges, and Opportunities: The 

U.S. Endocrine Disruptor Screening Program. AUEX .. ALTEX, 31:63·78, January 

Mnier, A; Vincent, MJ; Hack, E; Nance, P; Ball, W. 2014. Q(!fivation of an Occupational Exposure Limit 

for Inorganic Borates Using a Weight of Evidence Approach. Regul Toxicol PharmacaL 68(3):424· 

437. doi: 10.1016/j.yrtph.2014.02.oo 1 

Meek, ME;., Bolger, M; Bus, JS; Christopher, J; Conolly, RB; Lewis, RJ; Paoli, G; Schoeny, R; Haber, LT; 

Rosenstein, AB; Dourson, ML 2013.1\ Framework for Fit-for-Purpose Dose Response 

Assessment. Regul Toxicol Pharmacol66(2):2}4-40 (doi: 10.1016fi.yrtph.2013.03.012). Available open 

access. 

Moser, VC; Padilb, 5; Simmons, JE; Haber, LT; Hertzberg, RC. 2012. Impact of Chemical Proportions 

on the Acute Neurotoxicity of a Mixture of Seven Carbamates in Preweanling and i\dult Rats. Toxlcol 

Sci 129(1):1:16-34 (doi: 10.1093/toxsci/kfs190). 

Patterson, J; Maier, A;, Kohrman~Vincent, M; Dourson, ML 2013. Peer consultation on relationship 

between PAC profile and toxicity of petroleum substances. Regul Toxicol Pharmacal 67: S86-·S93· 

Available open access. 

Parsons, BL; Manjanatha, MG; Myers, MB; McKim, Kl; Shelton, SD; Wang, Y; Gollapudi, 88; IV1oore, 

NP; Haber, LT; Moore, MM. 2013. 

Sweeney, LM; Parker, A; Haber, LT; Tran, CL; Kuempel, EO. 2013. Appliciltion of Markov chain Monte 

Carlo analysis to biomathematical modeling of resplroble dust in US and UK coal miners. Regul 

Toxicol Pharmacal 66147-58. 

no 

.5 

Qj 

-g ose 

Haber, l T; Strawson, JE; Maier, A; Baskerville-Abraham, IM; Parker, A; Dourson, E ML 2013. "Noncancer Risk r\ssessment: Principles and Practice in Environmental and Qfcupational 

ro 

a.. 

L F 
36 


27172.031

Settings." ln: Aingh;nn, E., and B. Cohrssen, eds. ratty's Toxicology, 6th Edition, Volumes. John Wiley 

and Son:> Inc. 

York, RG; Parker, HM; Haber, l T. 2014. "Tesll'vkthods for i\ssessing rem<Jie Reproductive and 

Developmental Toxicology." In: Hayes, A.\N., ed. Principles and Methods of Toxicology, 6th Edition, 

rn press. 

ln Encyclopedia of Toxicology: Gad<~gbui, B; Vincent, M; Willis, A., Methyl isothiocy<Jnatej H<:~ber, L; 

Willis, A; Nance, P. tvtode of Action; Abdollahi, M., K<'lrami·Mohajcri, S., Gad<:~gbui, B. Ora!/Dermi'l! 

Reference Dose (HfD)/lnhalation Reference Concentration. 

Report of a Workshop to Assess the !\·lodes of Action of 

Styrene Ethyl benzene, and Naphthalene. Prepared Panel. 

Workshop Report. Lessons Learned, Challenges, and Opportunities: The U.S. Endocrine Disrupt or 

Screening ProgrJm. I\! so published ln ALTEX (See Juberg eta!., 

above). 

TER 
37 


27172.032

of Work by Project Sponsor 

2014 TERA Project Time by Sponsor 

43% 

Training 

ProJe~l:;.i':;ipop:;.()'$ 

5n 

Government/ 

Nonprofit 

P'J?~f'ds'SP"'nto"~ 
38 


27172.033

H NT 

www.tera.org 

;;")' 
39 


27172.034

TOXICOLOGY EXCELLENCE FOR 

RISK ASSESSMENT (TERA) 
40 


27172.035

3/Mitssion/Vision/Core 4il3oard of 

Directors 5/News 6/Giobal impa~t:}l/A 

year 2/Building partnerships 1 

Funding 

2!201S 1f:Hi\ 
41 


27172.036

. 

I 

Toxicology Excellence for Risk Assessment (TERA) is a non-profit and 

tax-exempt organization designed for scientific and educational purposes. 

To support the protection of public health by developing, reviewing and 

communicating risk assessment values and analyses; improving risk methods 

through research; and, educating risk assessors, managers, and the public on 

risk assessment issues. 

TERA was founded on the belief that an independent non-profit organization 

can provide a unique function to protect human health by conducting scientific 

research and development on risk issues in a transparent and collaborative 

fashion, and communicating these results widely. 

TERA is an independent non-profit and as such we embrace our core principles 

and values in all our activities. These core principles guide day-to-day TERA 

operations- from our consideration of new projects and sponsors, to our 

scientific evaluations and communication of results. 

Honesty and integrity 

Independence 

'~!!Transparency 

Collaboration 

312015 rERA An~ual Report 
42 


27172.037

Michael Dourson, PhD 

President Toxicology Excellence 

for Risk Assessment 

(1/1/2015 8/1/2015) 

Patricia PhD (2017) 

Interim President Toxicology 

Excellence for Risk Assessment 

Gail Charnley PhD (2015) 

HealthRisk Strategies 

Mike Fremont, PhD (2014) 

Rivers Unlimited 

Jennifer LS. PhD (2015) 

Department of Pharmaceutical 

Sciences College of & 

Health Sciences Mercer 

Laurie 

James 

PhD (2016) 

PhD 

Gregery S. CMA (2015) 

VICE CHAIR and FINANCE 

COMMITIEE CHAIR 

The Procter & Gamble Company 

Jon L PhD 

AUDIT COMMITTEE MEMBER 

PhD (2016) 

Alternatives to Animal 

Philip E. Tobin, 

(2016) 

MPAS 

NOMINATING COMJ\i1lHEE 

MEMBER 

Department of Physician 

Assistant Studies 

James D. 

CHAIR 

PhD (2016) 

Chase D. Wright, CPA (2016) 

AUDIT COMMITIEE CHAIR 

! S T R n n a l ort 
43 


27172.038

TERA Joins the 

Toxicology Excellence for Risk Assessment 

joined the Department of Environmental 

Health, at the University of Cincinnati's 

(UC), College of Medicine on July 6, 

2015. TERA will be known as the 

Toxicology Excellence for Risk Assessment 

Center (or TERA Center). 

TERA was organized in 1995 as a nonprofit 

with a mission to support the protection 

of public health through the best use of 

toxicity data. Now as a Center with the 

Department of Environmental Health at 

the University of Cincinnati's College of 

Medicine, we continue to accomplish this 

mission through independent evaluation 

of toxicity data and by interpreting and 

communicating risk assessment 

the protection of public 

health by developing, 

reviewing and 

communicating risk 

assessment values and 

analyses; improving risk 

methods through research; 

and educating risk 

assessors, managers, and 

the public on risk 

assessment issues. 

and Board of 

information through assessments and 

websites, organizing peer reviews and 

consultations, improving risk methods 

through research, and educating risk 

managers, assessors, and the public on 

risk assessment issues. TERA has a strong 

history of enhancing the use of chemicalspecific data to increase the rigor and 

transparency of evaluations aimed at the 

prevention of potential human health 

risks. 

The TERA Center will maintain this rigor 

and transparency, but will also mesh its 

work with the research findings of UC 

investigators in order to develop the next 

generation of risk assessment methods 

based on Toxicology 21 principles. 

UC·DEH: To improve the 

quality of life by identifying 

the mechanisms of disease 

and injury due to 

environmental exposures 

and genetic factors, and by 

developing effective 

methods of preventions 

and interventions. 

5120 5 ERA Annual R port 
44 


27172.039

Philippines 

8/25/2015·8/31/2015 

Dr. Michael Dourson served ~sa 

US delegate to the Asian Pacific 

Economic Conference held in 

Cebu, Philippines, where he gave 

several lectures on metal toxicity, 

and led a small study group on 

methyl mercury contamination 

offish. 

This organization meets 

periodically to share technology 

among member states. 

Geneva 

9/14/2015 9/25/2015 

Dr. Michael Dourson served on the 2015 Joint Meeting of 

the Pesticide Review pilnel to determine the appropriate 

acceptable daily intakes and exposures for up to 20 

pesticides. 

The meeting was highly interactive and impactful. 

A report is available at the World Health Organization 

website. 

6!201 T RA A 
45 


27172.040

TERA 

brings 

RISK 

ASSESSMENT 

to 

Nutrition 

Science 

In a novel approach 

to addressing the- effect of 

consumption of a mac:ronutrlent, 

TERA has conducted an evaluation 

of the relationship bctwe~n the intake of trans fatty acids {IF As), 

particularly industrially-produced !FAs {iTFAs), and changes in plasma 

low density lipoprotein cholesterol {!.DL~C}, partlcul,-!y in the low 

intake regton. 

Ttl is approach was unlque in nutritional literature, in rigorously consid€'ring a varlety of flexible curves, 

[ndudtng both linear and nonlinear models. The MOA analysis concluded that, although there are 

several data gaps pr0duding a rigorous appHc.<1tion of the evolved HHI Crlteda for evaluation of MOA, the 

feedback loops and homeostatic controls responsible for maintaining homeostasis oi cholesterol and 

triglyceride levels result ln a le-ss than line.ar relationship between TFA and lDl,C. Consistent with the 

MOA evaluation, the met<H·egression found that an S~shaped curve ftt by the HHI model is de arty better 

than Hnear model, and linear model is not ~1cceptable. 

This novel analysiS has generated much interest in the nutrition <md risk aS$essment communities. It 

has been presented at severafverwes, including the ToxForum, and SOT-fDA Joint colloquium; 

publications are- in preparation. 

This work wos sponsored by the I LSI North America PHO Task Force. 

7!20!S rutA Ann\,la! eport 

1. 
46 


27172.041

Ozone Science and 

Working with the Texas Commission on 

Environmental Quality (TCEQ) and others, 

TERA organized a public workshop in April 

2015 to provide an independent evaluation 

and synthesis of key considerations for 

EPA's November 2014 proposal to lower 

the primary National Ambient Air Quality 

Standard (NAAQS) for ozone. A diverse 

group of well·known and respected 

science and policy experts engaged in 

robust discussions on key issues, so that 

TCEQ and other attendees could gain a 

better understanding of the issues and 

implications. This multi·disciplinary group 

of science and policy experts deliberated 

on the nexus between scientific findings 

and implications for public health. The 

focus was on science related to the level 

(concentration) of the primary NAAQS and 

an independent evaluation and synthesis 

of key policy and other considerations for 

approaching the difficult and important 

ozone NAAQS decision. 

Presentations, background materials and a summary report are available at 

Framework for 

How does one identify an exposure limit (toxicity reference value, or TRV) 

for an intermittent exposure (e.g., one day/month for 40 years)? Should one use an acute 

or a chronic limit for this sort of scenario? How does one decide? 

Intermittent exposures such as these are common in m;my sectors, including manufacturing, 

waste site cleanup, food safety, and consumer product exposures. Led by Lynne Haber and 

in collaboration with Bette Meek and Health Canada 

scientists, the TERA team developed a framework for 

addressing such scenarios. The framework presents an 

integrated, tiered approach that assists the user in 

identifying when existing TRVs can be applied directly, 

and the adaptations needed to assess the acceptability 

of short-duration or intermittent exposure scenarios. 

A manuscript based on the framework is nearing 

publication, and Dr. Haber shared the framework in a 

Risk Assessment Specialty Section webinar. 

See 

81 0 51 RA Annual H port 
47 


27172.042

TERA Scientists Assist With Harmonization Effort in 

Pharmaceutical Industry Like other industries, the ph~rmaceutical industry has to 

manage chemical safety issues-both for workers and consumers. The TERA Center has 

been working with toxicologists and risk assessment scientists from pharmaceutical 

industries, consulting groups and academia to discuss current practices for exposure limits, 

evaluate inconsistencies across guidance documents, identify key areas for harmonization, 

and document best practices for risk assessment of pharmaceuticals. 

"Harmonization doesn't necessarily mean standardization," says Andrew Maier, PhD, an 

associate professor in the Department of Environmental Health and TERA Center codirector. "It's more a matter of understanding the basis for safety so that we enable savvy 

users of the risk assessment materials. 

Maier and Alison Pecquet were key organizers and facilitators for an October 2014 workshop 

that was convened in New Brunswick, New Jersey, to identify and address further 

opportunities for advancing harmonization and best practices in deriving and applying 

acceptable daily exposures (ADE) in pharmaceutical manufacturing operations. The 

workshop effort was spurred from a benchmarking assessment to compare current 

methods in risk assessment for pharmaceuticals. 

Fallowing the workshop, an article summarizing key workshop findings was published in the 

September 2015 issue of Contract Pharma, a trade magazine. 

The article concluded that a "harmonized set of recognized scientific principles is needed to 

inform individual efforts in calculating, interpreting, and implementing pharmaceutical risk 

assessments." 

"W2 are currently working on a series of 10 articles associated with each workshop topic that 

will appear in a Special Issue of Regulatory Toxicology and Pharmacology in early 2016," 

Pecq uet says. "Our goal is for these reports to shed light on inconsistencies and data needs, 

le.;d to further research of the knowledge gaps and contribute to informing decision making 

among risk assessors in the pharmaceutical industry by providing a 'guide to best practices."' 

"Ultimately, we aim to have one publication that summarizes l<ey issues in this 

area to help users harmonize and use best practices1 (J/1 in one place." 

912015 TERA Annual Report 
48 


27172.043

SPECIAL ISSUE: State of the Science of v<...• .. uu•auv• Limit 

Methods and 

The National Institute 

for Occupational Safety 

and Health (NIOSH) 

conducted an effort to 

identify and 

characterize leading 

issues pertaining to 

OELs and their 

development through 

research, which 

culminated in a 

collection of articles 

focused on each key issue. Those articles 

and the key issues they explore comprise a 

Special Issue of the Journal ofOccupotional 

and Environmental Hygiene. The goal of this 

effort is to describe the issues related to 

education and communication of science 

principles and to understand how they can 

be incorporated into (and thereby impact) 

the practices of OEL development and 

interpretation. Focusing specifically on the 

state-of-the-science in the fields of exposure 

science, occupational hygiene, risk 

assessment, and toxicology this effort 

sought to provide a clear description of how 

advances in these research areas can 

contribute to the practice of OEL settingby reviewing the methods used for most 

OELs that are currently available as well as 

new methods that are actively being 

incorporated in the OEL process. An 

essential topic included within the set of 

complementary and interrelated articles 

dedicated to this pursuit is the 

consideration and interpretation 

of OELs in the context of 

evolving risk management 

practices. The articles are 

intended to serve as a current 

critical review of occupational 

risk assessment methods that 

will enable occupational hygiene 

professionals to have a dear 

understanding of the science 

methods incorporated in the 

OELs they develop or use. 

v\lhile the list of topics for OELs covered in 

this supplement is in no way exhaustive, it 

does represent some of the most relevant, 

promising, and readily applicable scientific 

advances that can be integrated into risk 

assessment and management of 

occupational hazards. The purpose of this 

collection of article is to inform the 

practitioner, stimulate the researcher, and 

provide a basis for more protective and 

scientifically sound guidance and policy. 

10 I 2 0 1 5 l t R A A n n a I R e p o r t 
49 


27172.044

TERA's Eco 1\ssessment 

Ms. Alison Pecquet, M.Sc and Dr. Charles Pittinger, TERA Fellow, along with CJdditioflal TERf\ 

st~ff ;:md external coliCJborCJtors are working tl) provide support for environmental 

risk·related services. 

plant hioaccumu!<1tion above certain 

concentrZltions, with the 

assumptions that these plants could 

then be used to manufZ!cture 

consumer products and therefore 

Pesticides Control ;,sked 

scientific support to examine 

whether current pesticide 

residues have the potential 

to affect the lobster industry 

in Maine directly or via impactr--~L ____ .Lcnc<lill."""'=~--, 

on other marine organisms 

through review of the open 

literature for aquatic 

toxicology and 

bioaccumulation studies. 

CLEAN WATER: Working with the 

Electric Power Research Institute 

(EPRI) to help facilitate a consistent 

approach for conducting peer 

reviews of required studies for 

cooling water intakes in facilities 

that withdRlW >125 million gallons 

per day for §316(b) of the Clean 

Water Act compliCJnce. 
50 


27172.045

Partnerships 

1~er 

A collaborative effort to 

organize the world's risk data 

Through the Alliance for Risk Assessment, a group of organizations huve come 

together to build the world's premiere database of human health risk values. Building from 

TERNs lntemationol Toxicity Estimates for Risl1 (ITER), this effort has been dubbed ITER+ and 

seeks to first expand tile database offerings to include tl1e European Union's Derived No 

Effl'ct Levels (DNELS), and then additional values to be determined. ITER is current!)• 

available via the National Library of ,Vledicinc, and includes risk values from EPA, ATSDR, 

IARC, IPCS, and more. The ITER. /\dvisory Committee is responsible for prioriti:ing the 

addition of risk values from new sources. 

Situation: Exposure analysis requires the use of reference values to qualitatively understand 

exposure data. Currently, these values are developed by a number of rese<Jrchc:rs and/or 

authoritative bodies and reside in a variety of locations. Searching for these values can be 

time-intensive, values identified can be of varying scientific quality, and often additional 

expertise is needed to conduct a screening level exposure ilssessment. 

Proposal: Build upon the existing data housed within the International Toxicity Estimates for 

Risk Assessment (ITEH) database to inciude additional values needed for exposure and risk 

assessment. iTER includes peeHeviewed 11uman-health risk values and is searchable using 

the Toxicology Datil Network (TOXNET) on t:1e NationJI Library of fvledicine's 

website (http://toxnet.nlm.nih.gov/newtoxnet/iter.htm). 

The Alliance for Risk Assessment is organizing a coliaburative public/private partnership for 

the systematic addition of credible values to ITER+. The new additions will include the hea:th 

basis of the value and any assessment or uncertainty factors needed for the lack of key 

data. These additions will be for chemical ingredients that are known to be used or are 

found in consumer products. As the initia,l start for a systematically·phased project, REACH 

data for derived no effect levels (DNEL) for about 6oo chemicals will be added, followed by 

derived minimal effect levels (D,\t1EL), 311d the values tor the 100 most commonly found 

12 I 2 0 1 5 T ERA Ann u a I Report 
51 


27172.046

ad vane<; the practice of 

fields uf toxicology, pt1annacology and risk assessment are undergoing a revolution in the usE 

of pathway-based approaches to evaluate the biological effects of chemicals. These fields 

would benefit from accessible tools that make big d<1ta convenient and intuitive to integrate, 

analyze, query and visualize~ The ain1 of this ancHiary meeting is to reach out to toxico!ogka! 

scientists and introduce them to the N!H big data programs. A panel of researchers provided 

short overviews of the BD2K and UNCS initiative and thoughts on how big data can be 

leveraged lor protection of people and the environment 

This discussion was held March 23,2015 Society of Toxicology(SOT) Outreoch Meeting in San 

Diego, California. 

I 0 I A n u ! R e 
52 


27172.047

the Workshop series has 

now completed 9 

workshops, bringing 

scientists -of VJrious 

affiliations and expertise 

tog etheL 

government, lndu'ltry scientific 

societies and nonpr{)fits- have 

contributed to the Workshop's 

mission to <-'!dv<Jnce the science of 

risk aSSCS'>J1li'I1L 

i 2 0 l s Tf: 

the \'Vorkshop series 

has now reviewed 

over 40 cas~ studies 

on a r<Jnge of 

topics. 
53 


27172.048

ARA Coalition 

1,4·Dioxane Reanalysis of a Regenerative Hyperplasia Mode 

of Action 

EPA's IRIS 2012 external reviewers of the 

1,4-dioxane assessment suggested that 

the histopathology slides from the NCI 

1978 dioxane cancer bioassay in mice be 

reviewed to ascertain whether non cancer 

pathology was evident. If evident, this 

finding would support the conclusion that 

the cancer MOA is regenerative 

hyperplasia. TERA scientists worked with 

Dr. Gene McConnell and staff of the NTP 

to reevaluate these mouse liver slides and 

found extensive non cancer pathology, 

thus supporting the regenerative 

hyperplasia MOA. 

This evaluation also suggested the need 

to re-evaluate the mouse liver slides from 

a series of Japanese studies on 1,4-

dioxane. Five US states and TERA 

scientists requested the full unpublished 

reports (including the relevant 

micrographs) from the study authors. 

These reports have been reviewed and a 

draft analysis was prepared. 

As described in our draft analysis, the 

additional information and translations are 

also supportive of a regenerative 

More information, including a 

project timeline, can be found 

on the project website at 

http:Jiallianceforrisk.org/14·dioxane-analysis/ 

hyperplasia MOA but with one exception, 

specifically, the reported findings from the 

histopathology and clinical chemistry of 

the mouse liver in the Japanese studies 

are contradictory. This may be due in part 

to the investigators changing the criteria 

for liver histopathology scoring during the 

course of reporting their results. 

The State of Kentucky petitioned 

the Alliance for Risk Assessment 

(ARA) Steering Committee to obtain 

additional histopathology documentation 

from the Japanese studies to inform 1,4-

dioxane's cancer Mode of Action 

(MOA). The intent of this project is to use 

this additional information, together with 

the earlier re-evaluations, in order to reach 

a conclusion regarding the hypothesized 

MOA for 1,4-dioxane's liver tumor 

formation (and potentially other tumors). 

The coalition includes 5 groups and others 

are welcomed to participate. An 

evaluation of the data is being done by 3 

pathologists and will be used in the final 

publication. 

15!2015 TEHA 4nnual Report 
54 


27172.049

What is ITERate? 

ITERate is a new program from TERA 

to review chemical risk values from 

published peer-reviewed journals 

for loading onto the International 

Toxicity Estimates for Risk (ITER' 

(www.tera.org/iter; 

http://toxn~t.nlm.nih.govl) Through 

ITERate, TERA convenes a small 

group of toxicology and risk 

assessment experts to evaluate the 

Enter ITERate. This process will help 

fill data gaps for missing values or 

How to Participate Experts in 

risk assessment are invited to volunteer 

for review panels. Authors of risk value 

papers are invited to submit to ITERate. 

outdated assessments. TCDD 

example: This controversial 

chemical has no risk guidance from 

EPA. The ITER database contains 

data from ATSDR for noncancer 

endpoints only. The ITERate process 

was utilized to upload an 

independently derived cancer value 

for TCDD. Now, states needing to 

act to protect human health 

regarding TCDD have access to this 

newly derived value. 

F 

0 

('__'t~N S ::-N~ 

1$]2.01$ TE:RA An:nua! Report 
55 


27172.050

+ Balanced, scientifically accurate 

chemical health information. 

Latest Updates 

Superfund Research 

Program, Harvard 

University 

Drug and Poison 

Information Center 

(DPIC) 

12015 TERA Aon al eport 
56 


27172.051

Training or 

Dose-Response Assessment Boot Camp continues to be our most popular course. Our 

original S·day course which is an intensive hands-on training in ha~ard characterization and 

dose-response assessment. 

Boot Camp Basics begins with an introduction to toxicology for risk assessors. It 

addresses the fundamental approaches used in hazard characteri~ation and dose-response 

assessment, as well as introducing complex concepts and modeling. 

Boot Camp Advanced Framework and Modeling provides applications of advanced 

concepts and models, including mode of a provides applications of advanced concepts and 

models, including mode of action evaluation techniques, use of dosimetry and PBPK models, 

benchmark dose modeling, structure activity evaluation tools and methods, systems biology 

and other tools essential to the advanced risk assessment practice. 

Practitioner's Guide to Development & Reproductive 

Toxicology (DART) A 4 hour webinar intended for health scientists and product 

stewardship professionals, addressing key issues for understanding and interpreting 

reproductive and developmental toxicity assays, as well as how such data are interpreted in 

a risk assessment context. 

Non-Cancer and Cancer Risk Assessment A 6 hour course providing key concepts of 

non-cancer and cancer risk assessment followed by a detailed discussion of the methods for 

hazard characterization and dose-response. 

Dosimetric Adjustments in Dose-Response Assessment A 4 hour course designed to 

provide basic training in dosimetric adjustments for oral and inhalation exposures in doseresponse assessment. 

Use of Chemical Specific Adjustment Factors A 6 hour course teaching participants 

methods for refining interspedes and intraspecies uncertainty factors based on 

toxicokinetic or toxicodynamic data, using chemical-specific adjustment factors ( CSAFs )/ 

data-derived extrapolation factors (DDEFs). 

18 I 2 0 1 5 T E R A A n n u a I R e p o r t 
57 


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Benchmark Dose Modeling An 8 hour course designed to give an overview of 

benchmark modeling software for cancer and non-cancer dose-response assessment. This 

course also provides hands-on experience in using the EPA 81\1105 software. 

Children's Risk Issues A 1.5 day course discussing the major issues relating to risk 

assessment for children, such as toxicokinetic differences between adults and children, 

consideration of windows of susceptibility, and adequacy of the database uncertainty factor. 

Mixtures A 2 day course helping scientists to understand and apply methods for risk 

assessment for multiple exposures or multiple routes ("mixtures risk assessment" or 

"combined exposures" or "cumulative and aggregate exposure"). Topics include additivity 

approaches, consideration of interactions, and strategies for addressing complex exposures 

scenarios. 

Occupational Exposures Urn it (OEL) Course A 4 day course similar to the DoseResponse Assessment Boot Camp, but focuses on the development of occupational 

exposure limits ( OELs ). The training covers the development of OELs, appropriate safety 

factors, exposure assessment, and hands-on activities to engage all participants. 

Globally Harmonized System (GHS) Training A training tailored to corporate needs 

and circumstances. TERA provides firms with written certification as proof of meeting 

OSHA requirements. We are familiar with GHS as it relates to the Environmental, Health and 

Safety (EHS) needs and interests of private corporations and public agencies alike. 

Emergency Management and Response Training A 3 day course touching on key 

toxicology and risk assessment concepts, with an in-depth focus on tools for preventing and 

responding to chemical emergencies including CAMEO, ALOHA, and MARPLOT. This course 

is offered on site to members of your ERM team. CEU credits are available from the 

University of Cincinnati. 

19 I 2 0 1 5 T E R A A n n u a I R e p o r t 
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Risk Assessment lecture Series TERA is sponsoring a new 

monthly Risk Assessment Lecture Series within the Department of 

Environmental Health, University of Cincinnati. The lecture series will be on 

a range of "risk assessment" topics from a variety of risk assessment 

experts from various organizations and fields of study. 

Dr. Charles Menzie, Global Executive Director for the Society of 

Environmental Toxicology and Chemistry (SETAC) and a principal with 

Exponent Inc., a science and engineering consulting company, was the inaugural speaker 

Friday, November 2o'h. He presented on "Using Causal Analysis for Evaluating Environmental 

and Health Issues." Since then, topics covered have ranged from issues on hazard & dose 

response assessment, TOXCAST[f0X21, epidemiology-based risk assessment, and asthma. 

Speakers have volunteered from various organizations and agencies, such as National 

Institute of Occupational Safety and Health (NIOSH), U.S. Environmental Protection Agency 

(EPA), University of Cincinnati, and many others. 

The Seminar series is held every third Friday of the month. Anyone outside of the Cincinnati 

area can participate via webinar. Details on the seminars and how to register can be found 

on the website at http:j/eh.uc.edu/tera/seminarsj 

20 I 2 0 l S T E R A A n n u a i R e p o r t 
59 


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21 I o 1 s R A A at Report 
60 


27172.055

Special Issue Articles 

• State·of·the·Science: The Evolution of Occupational Exposure limit Derivation and 

Application 

Historical Context and Recent Advances in Exposure-Response Estimation for 

Deriving Occupational Exposure Limits 

• Advances in Inhalation Dosimetry Models and Methods for Occupational Risk 

Assessment and Exposure Limit Derivation 

• Systems Biology and Biomarkers of Early Effects for Occupational Exposure Limit 

Setting 

• The Scientific Basis of Uncertainty Factors Used in Setting Occupational Exposure 

Limits 

• Considerations for using Genetic and Epigenetic Information in Occupational Health 

Risk Assessment and Standard Setting 

• Setting Occupational Exposure Limits for Chemical Allergens-Understanding the 

Challenges 

• Exposure Estimation and Interpretation of Occupational Risk: Enhanced Information 

for the Occupational Risk Manager 

• Aggregate Exposure and Cumulative Risk Assessment-Integrating Occupatlonal and 

Non-occupational Risk Factors 

• The Global Landscape of Occupational Exposure Limits-Implementation of 

Harmonization Principles to Guide Limit Selection 

22 I 2 0 1 5 T E R A A n n u a I R e p o r t 
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27172.056

li 

AJ!en, fl.L,IVUC Vincent, 0, 

A.ne-pt~d with miner revislan<>-, 

. 

I 

Banda, M,. fCL Mcl<im,l,T, Haber, J,A. Mtu::Grego1, 8.8. 1015, Qu~ntiHc<ltion of Krns mutant 

fraction in tht? lung DNA of toa~rosol!zed partitul,3te v.trhi:dlum Pt?rtto).Jde hy inhalation. Mutat Res Genet 

Toxknl Environ Mut&g('n. '"'H'JU'''''''u 

Bed., N., R. 6e.d:er, N, E:rrdguntl.l, W. fadalld., lt Gr.mt, G. Gray.(. Kinnan; J. WK!nd.J.l~wis, P. Nan«t; leP~')tt~:.mg€r, $. 

Santos, L ~lmon, M. Oo\lrtcn. 2016, 

Cope RB, K.Jce'i.\-' S, ~unon M. 2:015. A H~productiv~. deveiopn·tent.'li .md ""urobehavforaJ study foflo-.·ving QrJI exposut-e of 

tetr;)bromobisphenol A on Sprague-Oawtey Mts. loxkology. )01$ Mar :!";'~.!9:d9v59. 

Dotson G$, Hudwn NL MzJi-er A .• ~01S. Aded'iioo ~uppvtt h.tmework fw d1<tr..sttedzlng <1nd m&n.agingderrnal -exposure-s 

to eh~mkals. duriflg Em-erg(tncy Man.ag1Ni:1Nlt. .md Opt"'r.nh:rn:s. ! tmerg M.an.ag .•.• ,.,,.~-""'. 

JA.. Brown KIN, ft;:id St.l, M~rtinu JM. :.W16. A (as;;r Study of P'ot;antlat t·tvmao 

H~i!.lth lmp.ads from Pet.rofeum Coke fr>J:mfet Facllitt~s. Joumal of th~Alr & W.asle Manag"mf!nt Ass,oci,atlon. {Submittro} 

Greenbt>rg M, Goldst~fn 50, Anderson 

(h.alienges ar1d Opp.ortu:f\ities <'! 

Ass.essnent of Nnncaht~t 

rnlnor revi5iOrt5. 

Oour:on M, landis W, N-orth DW. 2015, Whither Risk Assessment: New 

Ri;k AnaL '!5 (111:1959-!968. 

Maf~r, A; Ovese:n, J; AUe~ C; Vork1 R: Gadacbu:i, B; Klrm,an, C.:· PMt, T; and Ouliion~s"Rivera:, A. 2015-. 'S.:)fety Asses.snwnt 

for Ethanol·64sed Evafu.lUQ.n of De~!oprni;nt<ll Ttnth;Jty PotentiaL Re?gul 

tvaluatkm of d! 

ror up to 8 W€'1?ks:. Muh•t R.o?::> Gen€-t 

Manjanatha. M.G,, S. {), She·hon, Y. Chen, B.L Parson-s, M.S. My-E'r:., B.B, Gollapudl~ t•U\ Moore-, t.T. Haber, ftC AU-t!l't, .and 

M,M. Moor~. 'Ethyl!!nt! oxide Is ~1 weAk rnut<iSCJ\ M the t:il kK.lH .n ~walu4teci in the-lung of rn.alc Big Bht~ mktt exf.Xtrs:ed for 

up to ll we~k;; by inhalation. 

PittlogN, CA., p-ecqull!'t (Witlb:}1 A.M • .2016. Aquntit To'J\idt)t ~nd Blorom:entrat!on (>fT~?:tr;;bromoblsphenol A in Aqueou'i 

and Spiked Sedlmi.'nt txpo.-sttres. to fJSh, AlgJ~, and Jn...-ertR-tm~t('~;.. f5,utnninedj 

Rothi:!nbachEr, K., Pe-tquet (Witlis} A.M. 1016. Effe<:Js ofthJ? bromioated flarne retardant t~tn~brornobhphcnoi~A tlBBPAJ 

on snlt microo!'g<:fni~m:;, earthwmn·r:s, ttnd see-dling t.>m~rgenc£<.j5ubmitrt•dJ. 

Rekhardf J. -and t..T. t·h11ber. 2016, Mod(" of "ctio-., I?YI.!Io~nk~n for the dftd of tum.<:. blty ti-dd"> on tUl-C Af.('~t)t(>d with 

minor revis.lons.~ 

Sweeney, t-.M.1 L MatCalmM, l.T. Habe:r, (,(). Kuernpe-L CL lran. 2015. Baye:5rian 

:Ph-arrnacokinetic f?S'Ptt:} Modql cf lcrng·TO'frt11: Kln('tlts of Metal Nanopartido:rs in Rats. 73:!5!-163 

Waters M, McKernan l, Mai-er A, Jayjotk M, Sch:ae-ffer V, Brosseau L 201S. Exposure Estin·t.Hion and lnterpretJt!on of 

Cle<:upatl<m<ll Ri:.k: tnbanc't:~d lnformatkm for the Occnp.;;tiorhll tlisk M,'ln.<tgN. f Oo:-up Environ Hyg, 12 :$uppll:S~9-S11L 

23 I 2 0 1 5 T E R A A n n u a I R e p o r t 
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27172.057

We:ideman P., Bercu J.P., Callis C, Dolan Q,G .. Faria L Fiu&kiser A,, Gould J., Hay\!S E.P., Jolly R., Lovsio Barle E., Luo W., 

Molnar l.R., MoriMII-O E ,1 N.aurnann B.O., Ofs.on M., POstN T., Sandhu R., Sargent E.V •• Seaman C., Sehner C., Shipp S.K., 

Stanard B., Streete-r AJ., Sus$.1Y1an R., Walsh A., Willis A.M.~ Maier A, 2:01S. Deril.-'ing H~ahh-Based Exposure limits in the 

Pharmateuticai Industry. Contract Pharma, S.eptembe.r~ 7-4~80. 

Sock Ch~_pten. 

N.anc~. P ., 0. Kronor, L Haber :and M. Dours:cn.lOlS. Assessing Rides to Human H~alth.ln A~:der~nce Module i'n 

Blome-dk.a! Science-s. (Onlin~}. In-Press. 

N:u\(:CJ, P .. , 0. Kronu" L H:abcr and M. Oourson.1015. As.s.esstng R.l$.ks to limnan Health.1n R~ference Comprc-hensiv~ 

Toxicology~ Third fditli:m, Jn-Pte-s.s 

Sped:d !stu<!! in Jou.rr~at of Oc(-upatfcnal and E.rwironm~nta! Hye:ien-e: StatE: .of th"' Science Qf Ot:cup3ti<:~nal Expo.1ur-e Limit 

Metha-cl; and Guld.lln~e. available at ~~~~"r:!f!fQryJi~~l!%~.11~QL!Y.111I!l 

DeBord, n.G., L Burgoon, S.W. Edwards. LT. Haber, M.H, Kanht~ E.D. Kuemp!!l, n.s. Thomas, B. Yute-soy. 2:015. Sy$tems 

Biology and Slom.atbrs of Early Effects fur 0(.CUpational ExpO :sur~? limit Setting. J Occup Environ Hyg. 12 Suppll:$41-54. 

Dankovlc DA. Naumann. 80. M;der A. Dounon: ML~ le-vy LS. 2015. The Sd~ntific Ba<;.i~ of Urtcertainty Factor~ U$.ed ln ~tting 

Occupational Exposure limits, J Occop Environ Hyg.1015 Nov 2:5;12 Suppll:SS~6S 

Deveav M. Chen CP, Johanson G~ t<rewski D, Maier A, Niven tu, RippleS, Schulte PA.. Silk J, Urbam.rs: JH, Z.:~lk DM, Nfem~ier 

A.W, 2015. The Globalla.ndstape of Otcup>Mlonal Exposure Umlts-implero~ntation of Harmonization Princlpfe-s to Guidelimit Sele-ction. J Occup Environ Hyg.101S;11 Soppll:S.l27--44. 

Dotson GS~ M.aiCH" A, Sleg~l PD. Ander>.>on SE, Green 8J, Sti'faniak AS, Codisp-oti CD~ l(imber L 2015. Setting Oe;c:upaHonal 

ExposDre limits for Chemical AHergen:;.~Unders:ta-nding the Challeng~s., J Occup Envlroo Hyg. 12 Suppll:$82~98, 

Lenrz, T; Dotson, S; Wallams:, P; Maier, A; Gadae:bt~!, B; Pandalo1l, S P; tamba, A; Hearl, f; Mumtaz, M, 201S., Aggu~gate 

hposure and CurnvlaHve Risk Ass.e%ment -lnte-gr.atit18 Occ.up.ttlonal and Non-occupational Ri~k "Factors.J Oceup, Enviro-n. 

Hyg. 12 Suppll:SllJ-26 

Mai-er A. lertU TJ, Mae Mahon I(L, McKernan lT, Whittaker C, Schulte PA. 2015-. State·of~th.e-Sden<:e: The Evolution of 

Or.cupation.al Exposure limit Derivation and Application. J Ckwp Environ Hyg. 2015;12 S.uppl 1:54-6 

Sargent tv. Flueddger A, lovsin Boule E, Luo W1 Molnar l. Sandhu R1 W<eideman P. 2016. The Regulatory framework for 

Prev'@-nting (ross-Contamination of Ph~nna-t@Utit.al Product11: History and (.onsidcrat!om. for the Futor~. fn preparation for 

Regulatory Toxicafogv and Pharmacology. 

Olson M. Faria E. Haye-5 EP.JoH~v R, lo-~~Sin Sarie E, Molnar L. Naumann BO, PeequetAM1 Shipp B~ Sussman R, Wefdem:an P. 

2016. A Harmoni.tath::tn Effort for Ac:e:eptable EKposur<e Methodology Applie-d to Pharma.c-eutical Cleaning Va:Hda.tfon ... 

Communication with External Stakehofd~rs. Jn preporatlon for Regulatoty Toxicology and Pharmacol.ogy. 

Hayes EP, Faria ffJoUyR, lovsin Barle E. Molnar L. Naumann fh OlsonM, PecquetAM1 Shipp B, Smo;man R, Weideman P. 

2016. A Harmoni~aticm Effort for Act'\lptab-ft! Exposure Methodology i\pplied to Ph<Jrrnac:eutka! Cleaning Validation •• 

Opt-rational Aspe<.tt. In pn~poraticm for Regulatory TD)Iicology and Pharmacology. 

Faria f(~ Bercu J, Ootan OG. Morfnetlo E. PG-~\.Itt AM, Seam.an C Sehner C~ Weideman~ P. 2016. Using O<!'fatJtt 

M•tl>odologies to Der!"" an A<ceptable Dally Exposure (ADE).In preparation for Regulatory Toxicology om:! P/wrma<o/ogy, 

Reh:kard JF, M:atu MA, Naumann 60, P~cquet AM1 Piister T, S3ndhu Rt Sargrmt EV, Street-er AJ, Weideman P. 2016, 

Pharmacoldnetic and Pharnlacodynamic Cons.i-derations: whoi!n 0(orlving He-.alth~Baso:d E:<posur@ Umlts for Pha-rmaco?utlcah. 

Jfi preparation for Regulatory Toxicolagy and Phamw~alagy. 

24 I 2 0 1 5 T E R A A n n u a I R e p o r t 
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27172.058

E 

For Profit 

• American Chemistry Council 

• Amgen 

• Coca Cola 

Genentech 

• GOJO 

• Hamp. Mathews & Associatf.'''' 

Steptoe & Johnson 

Education Training 

Dose-Response Boot Camp 

e s nsor 

Collaborators 

• Alliance for Risk Assessment 

• Beyond Science and Decisions: From 

Problem Formation to Dose Response 

• Kids Chem<cal Safety Webpage 

• OARS: WEEL 

Government/Non-Profit 

• Consumer Product Safety Commission 

• Health Canada 

• International Life Sciences International 

• Texas Commission on Environmental 

Quality 

The sponsors listed above are sponsors that each comprise or more of our work. 

1) 1!: A 1\t1nu;1! !~t:port 
64 


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NT 

26 j 2 0 1 5 1 [ A A n n u a l R 0 p r t 
65 


27172.060

CURRJCUI.L'.H VIT·lE 

\lkh:td L. Dom·son. Ph.D., DABT. FATS, FSRA 

l 'ni1crsil1 of Cincinnati. Cnlkuc <>f\kdicin.: 

michacl.dourson a uc.cdu 

51 ~-55X- 79-f<J 

lllll l'antcca \\' av " -+ 19-X<J2-2502 t I rida1 s 1 

Cincinnati Oll-1~21l7-005<> 2017 -

EMI'LOY\lENT 

2017-

21115-16 

l<J<J:i-15 

I '!'li -'!-+ 

j<)')().<)i 

J<JX<J.l)(l 

l'lXO-R-+ 

l'roll·ssor. Risk Science Center (aka n:R,\ Center). Department of Fmirnnmcntal 

I kalth. l 'ni1 crsity oiTin.:innati. College or Medicine·. Cincinnati. Ohio 

l'roti:ssnr and llirc·cttll'. Toxicolot11 l'xcdknce t(n· Risk :\Ssl'ssmcnt Center. 

1 kpanmcnt pf l'm·inmmcntalllc~fth. l'niwrsity of Cincinnati. l'ull'-'gc pf 

\kdicine. Cincinnati. Ohio 

Dirccwr'Prcsidcnt. 'I oxic·ology E'<cdleno:c l(n· Risk t\s,;c·ssmcnt. Cincinnati. (>hiP 

l'hicf. Svstcmic Toxicants ,\sscssmcnt Branch. 11

nl'ironmcntal Criteria & 

:\,;scs,;m;,nt Onice ( EC\0). l :.s. Environmcntall'rot<:ction ;\l!c'ncl { LP.\ ). 

Cincinnati. Ohio ' . 

,\ssociatc· Dircchw. H'i\0. Cincinnati. Ohio 

Chief. Pesticides and To.xics Team. J-:1',\. \\'ashington. ll.C. 

('hie!'. i\kthods h·aluation and llc1dnpmcnt StafL FC:\0. Cincinnati. Ohiu 

l.c<~ckr. :\cccpt<~bil' llaily Intake (:\Dll Uroup.I:C;\0. Cincinnati. Ohio 

StaiTToxicnlngisL IT:\0. Cincinnati. Ohio 

Elll 1( ·.\TI0.'\1 

I 9XX-S'J ·xc·cutive Potential Program. l .S. (>nice ,,r l'ersnnnd ~ lanagcment 

lliplumall' of the ,\mcrican Ho<~rd ol Toxiwlog, 

1975-SO \ :nivcrsity of Cincinnati. ( 'olkgc ,,f .\lcdicinc. l'h.D. degree in toxic<llngy 

1'!70-7-l 

TE.\CIII:-.iG 

I ha\l' lectured in courses at the l!raduak level in several universities and institutes: haw lectured 

high sd1ool stucknts on the gcnc~·al principles ol"toxicolog' <Wcr sc\cral ,cars: and hme talked 

\\ ith !!radL' st:hool students nn :-1C\\.~ral occasinns about careers in science and my cxpcricw.:cs in 

,\frica. I participated as a member of the l'h.ll. thesis committee nfllr. '-:atalia Fomnda of the 

\linistr, of' I k:1lth. :\e11 /calami. 
66 


27172.061

H.ESE.\HCII: INVITED I'HESENTATIONS (Sl'll·rtrd) 

"( 'urn.:nt status nr Benchmark Dose Modeling l(lr .1-'VhltHlchlornpropanc-1 .2-di\>l {3-\1CPD)"' 

c;crman Fat Sckntists Association and the German Fcdrnttion for Food Law and Food 

Seicncl'. lkrlin. (icnnany. June 20. ~017. 

"I kalth risk assL'SS!llL'tlt l(>r pL'rchloratc: :\c11 dirc·ction in 1-:l'A 's nwdding appmach t(>r 

'"tablishing standards" 

AnH·ril'an \\"atl•r \\"m·ks Association . . ·\nnual Conference·. Philadelphia. 1':\. June 1-f. ~017. 

"I f<v,lrd icknti lication" 

"Dose response assessment" 

··1:xpnsut\.' assL~ssmt:nt·· 

··Ris~ charactcri;ation" 

Atcnl'O SdJUnl of ,\clrdicinl' ami l'ublk llcalth. i\lak;l!i City. Philippines. June 1-2. 2017. 

"Risk .\sscssor Certification" 

Taiwan Cha[H<'r of tlw Society for Risk Analysis. Taichung City.laill"an. i\1ay 24. 2017. 

"'(hen ic11 c>i"risk asscs,;mcnt'· 

"lla;ard idcntilication II: ( ·anccr" 

"Do:<c response assessment II: Cancer" 

""Introduction to dose rc~ponsc assc:ssmcnt modeling" 

""l'sc· ol' l'llPK moddin)! in risk assc·ssmcnt" 

"'Risk charactcri;ation" 

The Rl•gional Training l'rogram nn Hisl• Asscssml·nt, lliblinthcca •\lexandrina. Aic\andria. 

Jg,pt. .·\pril24-27. 2017. 

"\lanaging the non-canc·cr risks a hawrdous 11ast<.: sites: Trichloroethylene tTC!i) as a cas<: 

study·· 

A"nciation feu· Fnvirnnnumtalllcalth and Scit•ncl'S (A EllS) Fnundatinn. San llic•go. 

( ·alif(,rnia \larch 21. 2017. 

""The concept of hornlL·sis and application in risk assessment" 

Sncil•ty ofToxil·nlogy. Baltimore. :vlnrvland. \larch 14.2017. 

"!lie concept of hormcsis and application in risk aS:<cssment'' 

Snl'irt~· fnr Hisk Analysis. San Diego. Calili>rnia. lkcunbcr 12. 2016 

"\kchanics of Risk :\sscssnwnt'· 

In 11orhhop <'n Risk i\nal1sis. lnstitntl' for llnu~:ml' Studil'S and the i\h·rcatus Center· at 

George '\lasnn t:ninrsity. Portland. OrL·gon. June IR'h. 201(>. 

"'Y cs. ·Thrc>holdablc' Carcinogens ,\rc Still Delaney Carcino)!clls" 

\1ichacl L f)'"'"""· l'h.D .. IJ.\IH. FATS. I·~RA 
67 


27172.062

Roundtahk Sessiun: Is a ··Thn:sholdahk'· Carcinogen Still a Ddancy Carcinogen'.' 

Society nf Toxicology. '\e11 Orleans. Loui:<iana. \larch 1-l. ~0 I 6. 

•·IJistinguishill!( heti\CCn \ lmk and \ kchanism or ,\ction. and Some Ke) En:nts l(lr \10:\'' 

Cc>lloquium: Role or \h>de of ,\ction in Dose-Response• ,\sse·ssment l(lr Carcinogens. 

Food and Drug Administration and the Sncict~· of Toxicolog~·. Colkge Park. !\·I at') land, 

February 25. ::'0 I 6. 

"llannoniting ( lU .s: Commonalitie:.; and I li lkn:nces" 

h:c~·note tall; at the· annual meeting or the Occupatiomll Tuxicology Roundtahlc. :\e11 

llruns11 iek. :\e\\ Jersey. Octohc·r 4. 201 5 

--r~isk assessn1L'nt and hazard identilication 1\.Jr mewls" 

"I Iuman health cas.c stud1: mercury c·~pnsure and essential metals" 

"lltunan hc•alth eritc·ria and standards" 

Asian Pacific Economk Conference Workshop on yJt•tals Risk Assessment. ( 'ebu. 

Philippines on 2X-19th :\ugust 2015. 

"llepatoto~idty" 

"( 'ardiac ro~icity" 

"I huard ldenti ticatinn 'Dose Response" 

"I::-; pnsur,; .-\ sscssmcnuCharacteri;cm ion .. 

I ntcrnational Workshop On Comprehensive Toxicology. lkngaluru. India. July 27-~ I. 2015. 

"Defining the range (\r the rcfcrcncc dnsc: imprc·cisi,,n 1 ersus uncertainly .. 

The TCE Re\ olution and its Permanent Impact on Environmental Due Diligence, 1-:DR 

Insight. '\ational Tcleconk·rcnce \\'chinar. June 2.J. 20 I~-

.. .-\ssessment and management of Flk River. West Virginia drinking water contamination 

incident. 20 14" 

llt·itish Toxicolog~· Socil·t~· Annu:tl Congress. Birmingham. liK. ;\pril 20. 2015. 

"Il:vard & J)(lse Resp()nse ;\sscssment: Roadmaps & !1-kthods riJr llsing 21st ( 'entury Data" 

Ohio State l 'niversity, Columbus. Ohio. 1:ebruary 23. 2015. 

"Practical < iuidancc on the DcYdopmcnt of a \ion-cancer !Iazard Range l(,r FfTecti1 e Risk 

.-\sscssment and i{isk \lanagc·m~nt nt'Contaminated Sites: _,\Case· Study \lith Trichlnrncthylcne 

and Other Ch.:mkals' 

Tri-Sen·ice Em·ironmental His!; Assessment Work (;roup. 0:aval1\kdical C~ntcr. 

l'ortsnwuth. V.-\. Jan. 21.2015. 

";\chances in .-\sscs~inc Food Additi1·c Safety" 

Sl'l Food, Drug and (osmetic l'a••kaging ~1aterials Committee. !'nod Packaging Summit. 

\e\1 Orleans. L\. N(n. I 0-12. 20 1-l. 

"\,lode or _,\t'lion and Dose-Response I: valuation or the Lff\:t:t of Parti;dJ, 11ydrogenatcd Oil> on 

I .D1 .-Ciwlcstcrol .. 

SOT-FDA Colloquia un Emerging Toxicolngkal Sdt•nce Challenge~ in Food and Ingredient 

Saf!'l~-. Colloquium Ont•. College Park. i\!D.I.i\'C \\'cbcasl. Nm. 7. 201-l. 

~1ichacll .. llnur'<>!l. Ph. fl .. DAB 1'. FATS, FSR:\ 
68 


27172.063

"Risk ;\sscssment Road maps & \kthods l(>r \:sing 21 '' Century I )ata" 

lntt•r·nationallnstitut~ of Synthetic Huhhcr· Prnduccr.s, lnc.llouston. Texas. N<n. h. 201-l. 

":\dvances in :\ssessim: lm:redicnt Saktv" 

Wor·k.shop on (;(~AS 6~tc~·minations. intcmation:rl Society nf Rcgulatm·y To:~.icolog~· :IIHI 

Pharmacnlogy. \Vashington. llC. Oct. 1-l. 201-l . 

.. Case studv ii.\; PartiallY llvdro!!cnakd Oil:< (l'I!Os)" 

Thl' Rok :ind I ·sl' of Ntrtri.tional Studies I Evahwting the Saf~ty of a Fond or lngr·cdient, 

I LSI "iorth AnH·r·ican Spl'dal Workshop. Washington. DC. .July 22.2014. 

"Dose R.:sponsc :\sscssmcnt Boot Camp---Lecture series· 

Tm.icology ExcdlctH'l' for l~isk Assessment CITRA) at (;ad.iah ;\hula Univcrsity, 

Yogyakarta. Indonesia. June 13-21. 201-1 . 

.. < lpportunitics <md Challenges Posed lly the\ "sc nf ·omics· data in Risk ;\sscssmcnt or 

\li.·.;~ures .. 

Tnxicolog.\· l~isli Assessment Confet·cncc (TRAC). Cincinnati. Ohio. AprilS. 2014 . 

.. ;\lliancc i(>r Risk Assessment (.I!U). EDSI'. ICI .. ScictKc and Dcci~ions .. 

:\lonsanto. St. l.ouis. \10. 1\pril Ill. 2013 . 

.. Risk .\ssl'~smcnt Road maps & 'lkthods l(n·l'sing ~ 1 '

1 Century Data" 

Weight or l·sid.cncc \\'orkshop. International Life Sciences Institute (I LSI) North ,\mcrica 

Technical Committee on Fot>d & Chemical Sakty. '\liami. Florida .. bmtary ~3-24. ~013. 

··:\dYancine human hc:alth risk assessment: ( 'hartine a Course thromd1 c.m1tnittce 

recnmmemlations.. ' ' 

Soeiet~· fur Rbk Analysis Annual ;\feeling. San Francisco. C\. Dec. '1-12. 2012 . 

.. lltm Individual Variabilitl is Current!\ FactorL'd into Risk .-\sscssmctlliRcl!ulatiotvlkcision 

\lakine.. · · -

Emerging Sciem:c l(>r l·:m iron mental I kalth lkcisions. The National Academics of Science. 

Board on !.ill: Sciences. llnard on Fn1 ironmental Studies and Tmdcolng~. \\'ashineton. D.C. 

.\pril IX-1'J. 2012. , 

.. ,\ llitchhih'rs Ciuidc to the CialaxY Llf Practical Risk i\sscssmcnt .. 

RL·sourcc sharing. partncring. and L:nnpcrati1c scicnc:c policy resolution. l 'S FI'A and Rc!!ion V 

States \'arnr Intrusion Vidl'O Conference ({numltahlc. Columbus. 011. ,\pril 12. 2012~ 

.. l'rohkm l(>rmulatinnto dose rc~pons.:: .'\th·ance 1ia the, Ill. I Beyond Sc:icncc and I kcisions 

\\ orkshops .. 

:'>lew England Ch:rph~r· of the Socict~· for Risk Analysis. Boston. \1:\ . .lanuar) 2·!. 2012 . 

.. Risk i\nah sis <>n the Coast .. 

Socicf) for ·Risli Analysis Annual Mt·cting. Charle-ston. Sl'. Dec. 4-7. 2011. 

"( ·urrenl l:m it"tll111lL'l11al Risk Assessment: ( icttin!.! read1· ll>r Cenlun 21·· 

.-\.,snciatinn of Government Toxicologists. \\'asiiingtui1. D.C. March 29. 2011. 

"Risk :\sscssment .. 

Glnhal Chemistry·. llaltirnon:. \lD. \'larch 22. 2011. 

\lichacll. llouN•n. Ph.D .. DAtH. FATS. I·SRA 
69 


27172.064

.. Peer Re' ie" and ( 'onsultatinn l'rn!!ram .. 

,\ml'l'ican Ch~mist1·y Council. \\',;sbington. D.C. 1:eh. I 6. 2011 . 

.. l·ishhm1r 

Risk 2!: Reali/.ing the hnurc of Risk :\sscssmcnt \Vt>rkshnp. lntl'l·national Life Scil'nc~s 

Institute. Washington. DC. Jan. I L 2011. 

"Drali Toxicolol!ical Rcvi..:"· ol' I kxa,·aknt Chromium" 

Environmcntai'Protc~tion Agcnc~··s IRIS listening sc·ssion. Washington. D.l'. ~ovcmb.;r I:-\. 

2010. 

"l'crspcctiws of Air Pollutants: I kalth l:l'fccts Research l'pdatc Session: Risk Assessment. .in 

!i~t· :I'' ( ·<'nturr:· Ckan Ail· Fonnn. llnuston. TX. Nn,·. -L 2010. 

··,.\Risk ;\>s.:ssnwnt ami Rqwlatory .-\gene) l'crspecti1·e t>n :-.tixturcs ,\Jfccting Susceptihk 

Populations .. 

Socil'l~· of Toxicolog~· Annual Meeting. Salt Lake ('it). t 'tah. March 6-12. 20 I 0. 

··Risk •\nall·sis: The h nlution nl' a Science" 

Snci..t~· fm; IHsk Analysis Annual Meeting. llaltimnre. \IIJ. Dec. 5-l 0. 2009 . 

.. En' iron mental Risk in the 21 '' Ccntun" 

International Society of Regulatory 'i'nxicnlngy and l'harmacolog~·. Washington. D.C. Dec. 

'). ~009. 

"Fmcr!!in!! issues and rc!!ulator1· challen!!es and the science of risk assessment'' 

Kevno-1~ talk at the Mi<fwestcrn States 'Environmental Consultants Association biannual 

me~ting. Indianapolis. lndi,llla. l':tm:mher ~. ~009 . 

.. i\lakin!! a Successful Transition from <.im·crnmcnt to Non-Profit Sectnrs" 

Socict~·-of Tnxieolog~·. Baltimore. \lD. !VI arch l ~-20. 2009. 

"1:\posurc. and Risk Data: Fnsuring the Best Scic·nc·c" 

Socidy of Toxicology. ll<lltimore. \ID. \larch l:i-20. 20()<). 

"Scicntilk Peer Rc,·ic\\: .-\n (h~.:n·ic\\ 11ith Rcl'crenee to the International lo\icity l·:stimatcs 

!\1r Risk r!TFR! Database .. 

Soci~ty ofT!nicolngy .. Baltimore. \Ill. \larch 15-20.2009. 

":\ Risk :\sscssmcnl and lh:gu!ator~ !\gcncy Perspccti,·e nn Mi:xturc'S .\ rt'ccting Susceptible 

l'npulati<llls" 

Sncil'ty of Tnxicolng~. Baltimore. 1\lll. :VIarch I .:i-20. 20tl'J . 

.. Toxicol<>!!\' Lxcellcncc lc1r Risk .-\ss.:ssmcnt" 

Em ironnl~ntal Council Of States and lkJ>arllnl'nt of Defense Sustainahilit)· Workg1·oup. 

Washington. D.C. June 20-2!. 2007. 

"Predicting risk aho1·c• !-I';\ ·s Reference Dose (RID\" 

·1 nxicnlog~' and ri>k a>sessmcnt conference. \lultipll' federal agency sponsors. Cincinnati. 

Ohio. April 2:1. 2007. 

"l 'sing human data tn protect public health" 

Tn.>:icolo!!,. and risk asscssmcnt conl'crc·ncc. :\-lultiplc fcdcr·al agency sponsors. Cincinnati. 

< lhin. !\f~l:il 2.t. 2007. 

).!ichad t.. ll<>wwn. Ph.D .. !MilT. F..\ I'S. FSRA 
70 


27172.065

.. ,\ I list<l!·ical Pcrspccti\ e nn Risk ;\ssessmcnt and Areas rPr ;\dYmKemcnt"· 

I wcntY-1-:ighth :\nnual Meeting or the American College ofTo:.;irology. \)m. 11-1-L 2007. 

";\ir toxics: Risk bas..:d anal,sis" 

S: rnposium on air cmission.lhlln large industrial sourn:s. 1-:mlicottllousc. i\lultipk ~ponsors . 

. ·\ugust I(,. I 7. 21HI(>. 

"What Should \\·~ Rcalh Be Worried Ahmn'!'· 

Sc·al(,od & I kal!h ·os: issues. Questions and :\ns\\cr:<. S.:ssion V. :\ssc•ssing the Real Risb. 

lkp:H·tml'HI of Comnll'ret•. \\'ashington, D.C. lkccrnbcr 2005. 

"hrturc l !se or lklinrlt :\ssumptions and l'nc<:rtaint) l'aclt>rs" 

\lichigan State t:nin-rsit~·. Centu for lntegratinToxicology. April g_ 2005. 

"\il'rcun RcQulation: 1-ishinQ 1:or The Facts :\bllut Risk" 

States ;nid N;~tion Policy Sun;mit. American l.cgisl:1tin Exchangl' Council. Washington D.C. 

lkccmhcr ~- 2004. 

··.\cccptahlc Daily Intakes (i\Dis) and th.:ir ;\pplication in the Regulatory l'rnt:css" 

i'vtct:ting or the Technical Committee nn Fond Toxicology and Safety 1\sscssmcnt of the 

lntrntational Life Sl'irnccs Institute. 0/11rlh ;\mcrica. Washington. DC. :'--Jm·. 311.20114. 

"IIttman dosc·-n:sponsc asscssm.:nt of' copper" 

Science Symposium Lpdatc on Science Supporting the H · \\>luntary Risk ;\sscssmcnt. 

lntrrnation:tl Copper Association. Rome. May 17. ~00~. 

"lnt..:gration of Toxicity and Mokcular ~-lcchanistic Data for l\online11r Dose-Response 

:\sscssmc·nt. ,\pplicatinnto Systems Biology ami Ris~ 1\sscssmcnt" 

2003 ;\nnual \,lccting. Suciet~· for Hisk Assl'ssmcnt. llaltimorc·. \l11ryland. Dec.:mbcr I 0. 20m. 

··tlistory of ILR.I Ct><mlinatcd l'ublic.'l'ri' at.: Partnership on Perchlorate R.:scarch" 

l'.:n:hlorak Stat.:-of-thc-Sci.:ncc Symposium. Univcrsit~· of :'1/chraska, Ccntt•r for· 

Envinmmrntal Toxicology. ( )m;Jha. :--.icbraska. Scpt.:mh.:r 29. 20m. 

"Perchlorate' Rcf'cn:ncc Dose (RI])j" 

California En\'ironml'ntal Pr·otcction Agency. September ~<i. 2003. 

··small '\nn-Prolits in a Bil: Risk \\'orld: (ireasinl! th.: \Vhcds oi'Chanl!c" 

Fcatur.;d ~ kcting Spc·akcT.lhc :'liorthcnt California Chapter of the S•lcicty for Risk 

Analysis. Scptcmlwr 2~. 21!03. 

"Risk :\ssi.'SSilll:llt" 

In: ;\TSDR and RIV;\1 Fxpcrt !'and \kl'ling. on Chemical Risk ;\sscssmclll and Children's 

I k;I!th . .-\TSDR and IHV\1. Brussels. June 2(,_ 2003. 

"Dilfercntial Scnsiti' it,· Of Children ;\nd ;\dulls To Chemical Tosicitv" 

\-!it!lwskrn States Risk ;\ssessmcnt Sytnp<>sium. Indiana Dcpartmci1t of Environmental 

:VIanal!cmcnl. Indianapolis. I'\. July 25. 21102. 

"Modeling ( Jl' Population Vari11bility .. 

;-.,tid\\cstcrn States Risk :\ssessm<:nt Symrosium. Indiana llcpartmcnt of Em'imnmcntal 

\l:magcmcnt. Indianapolis. 1\! . .July 25. 2002. 

··Data llcriH·d Rcplaccmc·nt Of lkllmlt l'nccrtainty Factor" 

\lirhad I .. ()'""."'"· l'h.ll .. I JAB I. FA IS. FSRA 6 
71 


27172.066

Workshop on modeling oi'population Yariability. Society ofToxicolo:o·. NashYilk. TN. \larch 

19.2002. 

··stonc-1\gc Toxicity: !:rom htct(1J'S or I 0 to Compound-Sped lie :\djustmcnts" 

l'nivcr·sit~ of Cincinnati Medical Center. Dept. or Lm·ironmo:ntall kalth Seminar. NoY. 2002. 

"Dno:s l'lh:: l'sc O!'Data-Do:ri1o:d !lnco:rtaint\' Factors :\llo\\ Risk :\sscssors Tolkscriho: 

\ 'nccrtaint1 \lore Accurate I\'!" · 

Fillh ;\mnial \\'orbhPp on i·.\aluation ol'lkl:nllt 1 lnccrtaint~ Factors in I kalth Risk 

,\sscssmcnt. New .lers(·~· :\lcdical School. June I. 2001. 

"Risk :\sscssmcnt" 

Ill'S! Al!ricultural < 'ho:mical Sai'ct\' ,\ssco:smcnt SuhcommittL'C Stccrinl! Conunittcc \kctinu. 

International Life Scimccs lnstiiute. \\'ao;hingl<'ll. D.C'. :\pril I X. 20(}]. • 

"Risk Charactcri;:atinn l'ramc\\otl For Non-Ldhal \\'capon,;"' 

S) mposium on comparatin:: risk. Socict~· for Risli Analysis. Seattle. \\':\. D.::cc:mho:r 5. 2001. 

"1'\oncanccr Risk .-\sscssmcnt: i\ ~0- Y car PcrspcctiYc" 

Ohio Society for Risli Anal~·sis. "ioncanccr \\'(lrkshop. Cincinnati. June I.<. 2000. 

~·,\pproachc~ tn ass~ssing dose response asscs=-'mcnt rdatiuns .. 

( 'hul;~hhom Research Institute. Training course on cm·ironmcntal and health ri:;k asscssmc:nt 

and risk management or toxic chemicals. l~tk si. Bangkok. Thail<tnd. Nowmhcr 21. 2000. 

"( iuiddincs t(,r o\pplic;ttion or Dma-lkrivcd Uncertainty Factor in Risk :\sscssmcnt" 

l·ourth :\nnual \\.orkshop or L\'aluation or l 'nccrtainty Factors in I kalth Risk ,\ssc>smcnt. Nc" 

.Jersey :\h•dical School. i\lay ~-4. 2000. 

"Dctcrrnininl! l iSJ-:1':\ Rcl'crcnc·c Doses (RIDs) J(>r Essential \lincrab"' 

l'nin-rsity 1;j'l'lstcr. "iutrition & To.\icology l:xcdlencc:: li>r Risk i\ssc::ssmcnt \\'orkshop 

Scrie>. 1'\orthcrn lro:Jand. June IS. l'l<J'J. 

"I he Chalkngc·s or l ising Common \kchanism orTo.\icit~ In Chemical Regulation" 

Roumltahk scssinn. Socict~ of Toxicology. '\c\\ Orlenns. I.A. :--larch 17. 1999. 

"F;;trapolating Data From .'\dulls To Set l lLs For Children" 

Workshop on uppc::r lc:' cis or nutricnto. National Acadt•my of Sciences. January 21. I 999. 

in~.:idencc and scyerit" in relation to mat!nitudL' of intake: tnixcd .:ffcds. cakt!orical rL·u.rcssil)n·· 

International Life Sciences Institute. ·\\'orkshop on the o;ignificancc of cxc.ctrsions ol' intake 

abm..: tho: ,\DI. f\!il;tn. Jtalv. i\pri1:::'3. l'Nl\. 

"Should there he an intcrnati,mal accn::ditation oftoxicoi<H!ists'.' Accn:ditation in the l iSJ\"' 

International Congress ofToxicolog~·. Paris. France .. !til~ X. I<NX . 

.. ()tmlil\' lssu<.'s rclatinu to scicnti!ic inf(mnatil\n" 

l 1

S. LP;\ Data <)ualit)-and (i;tps Workshop. t:.s. Erwironmentall'rotcctinn Agency. 

Washington. D.C. October I\). I 998. 

"'\oncancr:r Risk :\SSL'SSI11Cnt: Impact or Research on the l indcrlying Science" 

International Socil>tY for the StudY of Xcnnhintics. lliltnnllcad. South Carolina. Octnhcr 2(,_ 30. 19'!7. . . 

":\ltcrnati\L·s to the NO,\EI. ,\pproach (B\I!l. prnbabilistic approach)" 

\lie had I. llour,nn. Ph.D .. 11,\lll. FAtS. FS!C\ 
72 


27172.067

Federal Institute l<n·lh•alth Protection ofComuml'rs and Vcterimll'y '\ll'dicinl'. \\"orkslwp 

on lise oft lnccrtaintv Factors in the Risk ;\sscssment Pwccss- Ne"·Dircctions. Berlin. 

< icnnany. \lay 5-7. ·l9'l7 . 

.. Risk Assessment ;\nd !he Rok Of Risk ;\sscssmcnl (!uidclincs .. 

\\'orkshop: FP,\'s neurotoxicity risk ass.:ssmcnt guiddin.:s. Socil'ty ofToxicolo~·. Cincinnati. 

Ohio. 'vlarch I I. 1 ')')7. 

"Noncanccr Risk Assessment: Impact or Research On The l'ndcrlvin~ Science .. 

Symposium V: Cancer and noncanccr risk a>scssnwnt. lnternatio.nafSocicty for the Study of 

:XI'nnhiotics. October 28. 1997 . 

.. (h-.:n ic\1: Cla>sical Risk Assessment" 

Risk ,\sscssmcnt in htahlishing Upper Reference I.e' ds or Nutrients Workshop. Fond & 

Nut1·ition Board, lnst. of '\lcdicinc, Washington. DC. July 15-1 h. J '>'16. 

··,\DI.Il"-lD. CTL. .. Thc :\lphahct Soup orJVkthods f()r Dose R~sponse ;\sscssmcnt" 

In: Conkrcncc on :\dvanc.:s in Toxicology and Applications to Risk ;\ssessm.:nl. ATSDR, t'.S. 

Arm~. Air Fnnc, !'i:ny and EPA. Dayton. Ohio. ;\pril 25. 19%. 

"( h er\iC\\ or U'A ·, Rd~rcncc Dose Mcthmlolo!.!\' .. 

In: Toxicolo~' P.:cr Rc,·ie\\ Board l\ketin!.! of th~·u.s. ,\nnv C.:ntcr l(>r Health Promotion am! 

Pre' cnti vc i\1cdicinc. ,\hcnkcn Pro\ ing di·ound. i'·dar: land.· January J 8.1996 . 

.. 1\,>n-Canccr Risk Asscssm.:nt: Three Practical 1\kthods !'rom:\ Decade or Rc:<carch .. 

In: Nc'\1 Techniques in Risk Assessment. International Business Communication. Orlando. 

Florida. Fo:hruan I'\. 19% . 

.. Evolution \'f Scicncc-basctl \ lnn:rtaintv Factors in Noncanccr Risk 1\ss.:ssmcnt .. 

The 2nd :\nnual Workshop on the b altmtion oiTI'i\ I OX Sal~ty Factors in llcalth Risk 

,\ss.:ssmcnt. !'lew .ll•rscy ;\h•dical School. Nutlc_<. N.J. December 6. 1996. 

"".;oncanccr! Iazard ldcntilication ami Dos<: R.:spnnsc i\sses:<mcnt. Part 2" 

In: Risk assessment. l :nin1·sit~· of Cincinnati, Cnllc~:c of i\lcdicinc. April 1 S. llJ%. 

"Dns<: Rcspons<: Class Exercise: ;\wdor" 

In: Risk assessment. t:ninrsity uf Cincinnati, Colll'gc of '\Jedicinc. ;\pril 30. l 'l% . 

.. Introduction to Risk ,\ssessmcnt .. 

In: Risk a>Scssmcnt. (lnivcrsity of Cincinnati, College of '\'lcdicinc. March 26. 19'!Ci. 

··S}st.:mic To.xicants. Cross Route E.xtrapol;nion. Complex 'VIixturcs·· 

In: f{isk assc,;smc·nt. l"ninrsit~· of Cincinnati, College of ;\lcdicinc. \lay n. J 'l'JS . 

.. ( >n Rc:lcn:ne.: !)()sc and Its { lndcrh in~.t Tn:-;icit,· Data Base" 

flcalth Canada. Tlw:shold of' Rcgt!lation Workshop. Onawa. Canada. March 2X. l 99:" . 

.. Prcsc•ntation of ( >nc<>in~ Work on Characteri;ation or Distributinns or Data which Sem: as the 

ll<l'is lin· { lnccrtailll~ h1~tor'" llcalth Canada. l'lanninl! "-·h:c·tin~ on { ineertaint' Factnrs. 

Oltil\\a. Canada. \lirrch IX. J'llJ:'. ' ' · 

.. :\lhanccs in Research l'~ed as an i\djunct to Toxicity Testing: EPA Perspective .. 

In: Regulatory \ lpdat.:: El';\ Regulation ami Tcsl Requirements. Amcrkan Coll<•ge nf 

To~ico!ng~'· Annual M<:eting. Vienna. Virginia. 1\rm:mhcr 12, I '195. 

Michael!.. ll<lllrs<ln. Ph.D .. 1),\BT. FATS. FSRA 
73 


27172.068

··:\lt~rnativ ~s To ·1 h.: Rl1l: What ,\r~ We ( icllinu .\nd I low \luch 1-:ft(n1 Docs It Cost?"' 

lnt~ra,..~ncy Ris~ ;\sscssmcnt l'<Hnmittcc. Statr'or!\ew .Jrrsry. :\pril25. I 1

1Y.f. 

··J>:mel Di,;cussinn"" 

In: Issues in r.:pr,>ductiY.: and dc\clopmental ris~ assessment-boron toxicity as a tl'st case . 

. \nnual Wintl'r Toxicology Forum. h•bnmr} 22. 199-+. 

"Regulator' Considerations of the L.S. I <Pi\'' 

In: Biological cfleCls "flo\\ Icv·L'i exposur,·s (HJ-:i.LF) and p\ltcntial implications f(>r rcgulatorv 

ckcision-ma~ing. American CoiiL•gc of Toxicology. :\nnual i'vketing. Octohc·r 26. 1'!9-f. 

--:o.:,>ncancer lmprov cmcnts Discussi"n !'and'' 

In: I fcalth c·llccts & risk assessment associated" ith nonearcinouL·nic. radioactiv·c amlmiwd 

\last e. Air· & \Vastc· i\lanagcmcnt Association. &7th Annual \kc·ting. June 2.1. I '>'1-+. 

""FYaluating Suhpopulations: I· ish Consumption .\chisnry i\kthodolog) .. 

In: EP:\ Workshop on chalkng~s in Risk Characteri/ati\Hl. t:.S. EnYironnwntal ProtL•ction 

AgL'ncy. ( 'incinnati. September X. I 99-+. 

"Inherent lmpn:cision of RtT)" 

In: Ll' ;\ IZ.:uional Ri,;k 1\ssessnrs' i\kdinu. l'.S. Environmental ProtL•ction Agency. Host on. 

\L\ .. \pril 27th. 199-f. ' 

""\ic\\ :"vkthods: lkm:hmark Dose"" 

In: FJ',\ Reuional Risk ,\ss.:ssors' ~-kctinu. li.S. Envinmmcntal Proll•ction Agcm·~·. Ho,;ton. 

\·!i\. i\pril'26th. 19'1-+. ' 

""Components oi' RisJ.. ,\sscssmcnt"" 

In: Risk assessment. University of Cincinnati, College of ;\lc!licirw. i\lurch 29. 19')-f (This 

same kcture \\as also ui,cn an additionalt\\o times at the Cincinnati State Technical and 

( 'otnmunit; College·"'; Scptc·ml,cr 27th ami ~ov ember l.'th ). 

""llmv Toxicit) !lata ;\rc· l 'sed in the Process of !Iazard Identification and Dt~>c-R<:spon,;c 

Assessment"" 

In: Basic Ri>k i\ssessmcnt: Current lkn:lt>pments. Continuing Education Course. Socil'ly of 

Tnxicnlog~. ~e\\ Orle-ans. Li\. i\larch 1-L l 993. 

""\lodil)"ing l :nccrtaint; l'act1>rs for 1\oncanccr Endpoints'' 

In: i\dv·anccd Topics in Risk :\sscssment. Continuing Education Ctll!I'SC. Society of Toxicology. 

:\c•" Orkrms. !.:\. \larch 1-f. 199~. 

"\loncanecr Risk i\SSL':'i~tnent" 

In: Course• ~nlitlcd "Introduction to Risk i\ssc~sm~nL" l"nivct·sih· of KL·ntuck.-. l.c·xington. 

1\.emucJ..y. Julv 2R. I '1'1_1_ • • 

""\:nncano:r Risk Assessment Science·" 

In: Risk :\ss~s:.:ment and the l·:nv·ironmcnt s~rics. llanard Center l(lr Risk ;\nalysis. llar·vanl 

School of l'uhlk Jlcalth. !Ins ton. \-1:\. February l h. 1993. 

"Statistical Research Plan nine of the Em·ironmcntal Criteria and ,\ssessmcnt Office"" 

In: Workshop on Oi"licc· of R~sL'arch and Dcv dopmcnt Statistical ~ccds. U.S. Environmental 

l'r·otcctinn Agcnc~·. Research Triangle Park. North Carolina. May 12. 1'19:;. 

""FI'.\'s lnlci!ratcd Risk lnl(mnation Systl'm·· 

~lichacl L. llourson. l'h.ll .. tl;llll. 1-xrs. FSRA I) 
74 


27172.069

lulnnatinnall'rogramme on Chemical Safety, World llealth Organization. ( i.:ne\ a. 

S\\itzcrland. June 17. 199.\. 

"\!oncnnccr Dnsc-responsc and Risk Charactcri7ation" 

In: Course on 1:!1\ iron mental I leallh Risk :\sscssment. \'ofer Institute of Occupational 

Health. LtllL-:. 1\,land. March 31. 199.\. 

"\lost Important l'robkms Fncountered in ()uantitati,·e Risk Assessment at thl' National or 

International I.e\ el" 

In: !\lccting nn ( \>nsultatiPn on (iuiding Principles and ;\.kthodology lt1f Quantitatiw Risl-

.·\ssessment in Setting F'posure I .imits. International l'rngrammc on Chcmiclll Safety, 

\\'orfd llcallh Organization. Langen. Germany. January 19. 1993. 

"Risk abOH' the Reli:rence DPse (f{f1)) Benchmark Dose (B\ID)" 

In: Conkrenee on the Risk Assessment Parmli>Cm after lcn Years. l'.S. Army, Air ForTe, \a\)' 

:unl EI'..\.Da~ton. Ohio. April 7. 19'1.1. ' 

"llenclunark Dose .-\pproach to Risk :\ssl'ssment" 

In: Fcdcrai-St<~te Toxicoln!!_Y and Risk Analysis (FSTHAC) Fall Meeting. Washington D.C. 

lkecmher 1-~. !99.i. 

"( h·c't-vicw of,\ ltematincs to Benchmark Dose .. 

In: Workshop on lknchmark Dos.:: :Vkthodology. Puhlic 1\orkshop sponsored by U.S. 

Environmental Protection Agency, American Industrial Health Council, and International 

Lifr Sciences Institute. Fairlitx. Virginia. Sept.::mber 2X-.l0. 199~. 

"De\ clopmenl o!' R!Us and the' IRIS Procc·ss·· 

In: Cincinnati Forum on Dose Rcsponsc Issue'S nl' Risk t\sscssmcnt f(>r Trivalent and l lcxav;1lcnt 

Chromium Salts. l'uhlic workshop sponsored h~· l'.S. Envinmmcntall'r·ntcction Agency. 

Cincinnati. Ohio. ,\ugust 19. i'l93. 

"The l 'sL: oCThrcshnld Limit Values for Determining Community Standards: Currentlssucs" 

In: Tutorial Session nn Threshold I .imit Values and Biological Exposure Indices. II th 

International Syslt:m Sakty Cnnl~rence. Ohio Chapters nf hoth the System Safct~· Socicl) 

and the Society fm· l{isk Anai~·sis. Cincinnati. Ohio. July ::'9. I 99~. 

"Tlw IRIS Procc·ss" 

In: Cincinnati Forum on Boron Contain in~: Chemicals: Risk Factors and Characterizations. 

l'uhlk IHH'kshnp sponsm·cd h~· t:.s. En~·ironmcntal Protection Agenc.v. Cim:innati. Ohio. 

l'~hruary II. 199.'\. 

"Introduction to Risk :\ssc•ssmc•nt" 

In: Tutorial Session on Em·ironmcntal and Occupational Risk Assessm<ent and Risk 

Communication. lith International S~stcm Sal~ty Con!'crencc. Ohio Chapter of the System 

Safety Society. Cincinnati. Ohin. July 29. l 99~ . 

.. !'he l :.s. EI'Xs l 'sc· nf llnL·crtaint\' Factors" 

In: \Vorkshop l>n Sal~ty ;\ssessmctlt I(Jr Non-Cancer Endpoints: The lknchmark Dose and Othcr 

Possible: .\pproachcs. California EI'A, li.S. EP:\ and U.S. A gene~· for· Toxic Substances ami 

Disease Rcgisu·y. Tiburon. Calil(lrnia. May 12. I 992. 

"Risk .c\SSL'ssmcnt: Who needs it''" 

All-Ohio Safct)· a!Hl Health Congress and Exhihit. Cincinnati. Ohio. ;\pril I. 1992. 

"Hridging the Cha~m: Breakthroughs N.:cded in Noneancer Risk Assessment'' 

\-lkh;wl L. llour"m. l'h.ll. ll:\lll. FA rs. FSRA Ill 
75 


27172.070

In: K<:ttcring S<:minar S.:ri.:s. L:ni\'Crsity uf('incinnati, Collcgl' of :Vlcdicine. Cincinnati. Ohio . .l~muary 22. 1992. 

"Role oi'Risk AnalYsis and Risk ,\'lanaccmcnt in the lJS' 

In: lrd ll.S.-Japan (!,"·.:rnm.:ntal t 'oniGr.:nce on Drinking Water Quality i'v!anag~·mt:nL 

(;onrnrncnts ofthl' United Sta!(•s and of .Japan. Cincinnati. Ohio. SL'ptemb.:r 22. 1992. 

"The· Rcil:rcnc.: Dose" 

In: Conkn:ncc on Trace Fkmcnts in I kalth and Disease. International Socil'tY for Tn1cc 

Element Research in llumam and Nordic Tnlct' EleUil'nt SocidY. Stockholn,l. S\\cdcn. i'vln) 

27. 1992. . 

.. :\o\ c:l ,-\pproachcs to th.: Lstimation of Noncanccr llcal!h Risk" 

International PrognlmiT!l' on Clu~mical Safety, World llcalth Organization. Cicnc\·a. 

Switzerland. January l (). 1992. 

"Th.: Rt:li:rcnce Dt>scs f(>r Chromium" 

In: \\'orkshop on Risk .-\ssessmcnt of Essential Elements. Puhli~ \\'orkshop sponsored by l'.S. 

EnYironmental Pr·otection Agenc~·. Agl'nry for Toxic Substances and Disease Hcgistl!'• and 

International Lifl• Science.' Institute. I lcrdon. Virginia. !\·larch 12. 1992, 

··Ih.: Rctl:r.:nce Dose .. 

In: Workshop on Risk Assessment of Essential Fkmcnts. Public 1\orkshop sponsored by U.S. 

En,·ironmentall'r·otection Agl'ncy, Agency for Toxic Suhst:mecs and Disease Regis!'!'• and 

lntl'l'n:llional Life Scil'lll'l'S Institute. llerdnn. Virginia. !\·larch I 0. 1992. 

"~o,·d Approaches to the Estimation of~oncancer I kalth Risk: Probabilistic R!l)s. lknehmark 

Dose. and Se1.:ritv ;"\lodclin'"" 

In: \\'orkshop on i~isk Assessment l(lr Noncardnogcns. Health and Welfare Canada. Tunney's 

Pasture. Otta11a. :\pril 29. !991. 

"No' el :\ppro:1ch<.:s to Non..:ancer llealth Risk ;\sscssment" 

In: 1'1',\ Regional Risk !\sscssors' 'vkcting. U.S. J•:nYinmmentall'mtertion Agency. Dt!n,er. 

Colorad\l. June 2:'i. 19'11. 

"Risk Communication-A Challcm!c li>r the I <JlJO's and BcHllld .. 

System Safety Society. Cincinnati. Ohio .. \ugw;t :'. 1 IJ<J f. 

"Quantitative Risk ;\ssessmcnt: The Rekrcnce Dose (RID) and Research to lmproYc this tvlt1ckl 

lndmlinl! the I .'sc oi' .'\ \erauc l 1nccrtaintv Factors" 

In: Sym1;osiurn on Neurotoxicity Risk Assessment: State of the ;\rt. Society ofToxicolog). 

Dallas. Texas. "larch I. 1991. 

"'\mel .c\pproaches Cor ()uantitatii'L' Assessment of Risks l(H Noncanc..:r I -:n<:cts .. 

Boston Risk Ass£·ssml·nt Group and New England Chapter of the Society for Risk Analysis. 

Boston. \lassachusctts. February 12. 1991, 

"Impact ol' Risk Rdatcd C 'onccrns on the EPA l'rngrams" 

In: ;\d\'~mcc'd Research W<>rkshop on Nitrate Contamination: Exposure. Consequences and 

Control. i\orth Atlantic Treaty Organization (NATO). l.incnln. :-.lchraska. Septc-mbcr I~-

1<NO. 

"! lm\ :\rt! En\ inmmcntal Criteria Dc\·doped''" 

II 
76 


27172.071

In: A course <:ntitkd ''J-:n,ironm<:ntaland Occupational I kalth Risk !\sscssmctll and Risk 

!vlanagcm.:nt." lkwlopcd I(Jr City of Cincinnati Counl'il and other local dccision-mak..:rs. 

Cincinnati. Obit>. \lay .1. 1990. 

··J\on-can:inol!cnit: Risk Assessment" 

In: Risk Assc~smcnt Workshop. Federal-State Toxicology and Regulatory Alliance 

Cornmittl'C. Washington D.C . .-\pril 19. 1990. 

"Risl< abo'c the Rfl) and lkndnnark Dose l'roccdun;s .. 

In: \Vorkshop to Discuss Noncanccr Risk Assessment \kthods.'Data 1\ccds to Support the Nc\\ 

Ck;m1\ir Act t\mcmlmcnts. II.S. Environmenhtl Protection Agcnc~·- Research Trianglt: Park. 

1\orth Carolina. Juh 23. 1990. 

--Rdcrcncc Dos<: (RID) .. 

In: Wnrl<shop to Discuss Nom:ancer Risk ,\sscssmcnt \kthods!J)ata Needs to Support the l\ew 

Clean Air ;\ct Amendments. l'.S. Em·ironmcntall'rofcction Agency. Research Triangle Park. 

'\onh Carnlina. July~-'- 1990 . 

.. (iuiddim·s { 'sc·d to ;\sscss Tnxicol<H.>icalllazanls: ( luantilkation Issues .. 

In: S) mposium on Acc.:ss ami Usc or'lnl(mnation Re~ourccs in Assessing llealth Risks from 

Chemical I:xposurc. Oak Hidj!l' i\ational Lah and l'.S. EnvironmentalJ>rotcction Agl•m·y. 

Knox' ilk. Tennessee. June 2l\. 1990 . 

.. lit>\\ Statute's and Lxccuti1.: OrLkrs i\lfcctth<.: lise of Scientific lnl(mnation" 

In: Regulation lk,elopment in El't\ Course. I'.S. En\'ironmental Pt·otel·tion Agency. 

Washington. D.C June 20. 1990 . 

.. Risk i\sscssmcnt and It,; l 'ses: Directions ofNe\\ Research" 

:':ationallnstitutc of Occupatiomtl Safety and llcalth (NJOSII). Cincinnati. Ohio. June 20. 

]<)/(<)_ 

.. I kalth l{isk i\sscssnwnt: Chronic Reference Dose' .. 

In: \Vashington ( 'ontl:rc•ncc· on Risl< Assessment. Center fm· En erg~· and Environmental 

\lanagcnll'lll. Washington. D.C. September 26. 1989. 

"I:P;\'s :\pprnach to lkn-loping ;\ccqltahk Air Quality Criteria .. 

In: -lth ;\nnual Conkrl'ncc. liAZTECIIlntcrnational. Cincinnati. Ohio. Sq1tc111bcr D. 19X9. 

··1 he l lmkr!Yin" Ba:;i,; of Risk :'vlanaucmcnt Decisions" 

In: -lth ;\nmlal c\mll·r-cncc. IIAZTE{II lntenuttional. l'in~innati. Ohio. Scptemh<"r 12. I'JS'J. 

"lkri,·ation or Risk Values bv FI'A .. 

llazanlous \laterials Man:tgl'mcnt Confcn•ncc and Exhihition/Ccnh·al. Rosemont. Illinois. 

\.larch 15. llJS'J. 

··The Rd'c·rcncc ll<>sc" 

Amcl"ican lndustr·ialllygicm• Association. :\nnualloxicolngy Symposium. Williamsburg. 

Virginia. :'\ugu~t I h~ l ')SS. 

--Rel(:rcncc Dose: Description and l 'sc in llcahh Risk Assessments .. 

In: 54th .\nnual i\ kcting. Amcr·ican Mosquito Control Association. Dcrwcr. Colorado. 

I d'ruar: 2. 19XX. 

\1i<ilacl L llmH-'<11>. l'h.ll .. DAB r. FA rs. FSI{:\ I: 
77 


27172.072

In: \\'orkshop on th~ Use of the EPA Tools in Stak Risk Assessment. l'iational Go\'Crnors' 

Association. ( 'npper i'dountain. Colorado. \lay 4-h. 19~:\. 

"Del ci<'J1111Cnt of ( )ral Rc·f~r~nc~ J)pscs" 

In: \\'orbhop on 1·:1' ;\'s Integrated Risk lnl(mmuion System: .-\cccss. l !s~. and Interpretation. 

t'.S. En\'ironmcntall'rnteclion Agcne~·. Lexington. l\lassadmsctts. July 22. I <JX7. 

''The Svstc·mic loxicit\ of .-\ir Pollutants: New Directions in I h::tlth Risk ;\sscssmcnt" 

In: Session 100: Balmiccd i\ppmach tn Risk ;\sscssmcnt. ;\nnual l\-kcting. Air Pollution 

Contml Association. \'c" York. :\ew York. June 22. 19X7. 

"Sale!\ Factors in :\on-Carcino!.!cnic Risk" 

In: \h;rkshop on Reducing [:ncertainty in Risk ;\sscssmcnt. i\'lil'higan State llni\'I.'I'Sity. l'ast 

Lansing. J\1ichigan. \ht) IlL I<Jl\7. 

"Nc·,, De1 dnpmcnt in the Derivation unll 1\ppli.:alitm of Acceptnblc Daily Intake Values" 

In: Workshop on Approaches to Ecological (l!1d 1 Iuman I h.:alth Risk Analysis !(1r Dispo,;al of 

( 'ontaminatcd Sedime-nts and !Iuman ( 'onsumption of Clllllaminutcd Seal(JOd. {i.S. 

Envirnnm~ntall'rntcction Agency and ll.S. Department of the Ar·my. Seattle. \Vashington. 

lkccmbc-r l(i. I<JX5. 

"!Iuman! k•1lth ;\sscssmcnt" 

In: Workshop of \Vater Quality-Based To:dcs C'unlrol. l'.S. Environmcntall'rot~ctinn 

Agenc~·. Philaddphi:1. l'cnnsyll'ania. Nn,cmbcr 14. I<JXS. 

--s,·stcmic I h.:alth llan1rd ;\sscssmc-nt" 

In:· Workshop on !Iuman Health Criteria. l '.S. EnYirnnmcntall'rotcction Agency. 

Philadelphia. Pennsyhania. October 3. I9S5. 

··Nove-! 'vlcthods liH· the- l'stimation of J\cccptablc Daily Intake" 

In: Course entitled "Risk :\sscssmcnt !01." l'.S. Enl'imnmcntall'rntcction Agency. 

Washingltll1. D.C. February 19. I 9~5. 

--t.:sc of Risk .'\sscssmcnt to Set Sail: Levels" 

In: Conli:n:ncc on Emerging Issues in hwironmcntal Analysis and Planning: Implication I(H· 

l'rokssional Education. t:nivcrsity of Cincinnati. {f.S. Ann~· Cor·ps of Enginccr·s and the l'.S. 

Environmcntall'rutcction Agency. Cincinnati. Ohio. April 12. I9H:i. 

"En,·irommmtal Risk ,.\sscssment'' 

In: Course on Applied Toxicology. {<ninrsity of Cincinnati, Collcj!c of Medicine. Cincinnati. 

Ohio. ,\pril (l. I 'IX.f. 

"Ttlxicit' Risk .-\sscssmcnt'' 

U.S. En\ ironmcntal Protel'lion Agency. 1\tlanta. Ucorgia. July 7. I9S.f. 

"I he Rcgulmor:- llistory and J::.;pcrimcmal Support of Uncertainty (Sali:ty) Factors" 

In: Wnrkshop on Toxic ;\ir Pollution: !\ Rcgulatnry Challenge. Stale and Tl·r·ritorial Air 

Pollution Control Oflicials. Washington. ll.t'. October I 0-1:2. I QS.f. 

"lraditiPnal ;,leans of i\sscssin!.! the Sali:tv oi'Non-carcinocc•ns" 

In: Symposium on Federal Rcgt~lation of (·arcinogcns. Am~riean Chemical Society. 

Washington. ll.C. Au!!USl :10. 19X:l. 

"The I' .S. l:m iwnml'ntal l'wt~ction .'\gcncy Perspccti1 c' of Qualitative Risk :\sscssment" 

\firll<iel l.. l lt•UNll1. Ph.ll .. DAB I. t·XI S. l SR,\ 
78 


27172.073

In: Course on Applied Tnxiwlogy. University of Cincinnati, Cnllrgl' of Medicine. CiiH:innati. 

Ohio. \larch ~0. 19S~ . 

.. !]';\ Crill:ria Documents" 

In: Filih ,c\nnual Course in the Prindpks anti Practices of Genetic I u:dcolog'. Dl\ i'inn of 

l'.m ironmcntal Tnxicoh>gy. l 'ninrsity uf Tcxus :VIcdical Bnmch. Galves{,)n. Texas. 1980 . 

.. Quantitative Considerations in l :rl'thanc Induced i':'e<>plasia .. 

In: Toxicology l)j,·ision Seminars Series. l'nil'ersit~· uf Cincinnati, Cnllcgl' of Medicine. 

( 'incinnati. Ohio. ( lctnbcr ~5. J 979 . 

.. Some Qmmlitati\ e Aspects of Chemical CarcinogL'Ill'sis II" 

In: Toxiwlog~ Division Seminar Series. University of Cincinnati, College nf Medicine. 

( 'incinnati. Ohio. February 2. 1979 . 

.. Some <)uamitatin~ ;\spects ,,f Chemical Carcinogenesis 1 .. 

In: Toxicology Dh ision Seminar Series. l 'ninrsity of Cincinnati, College of Mctlicinc. 

Cincinnati. Ohio. \larch 7. I '178 . 

.. ( 'omputcT Simulation Studies on Kehoe's I .cad Data .. 

In: Toxicolugy Di,·isinn Seminar Series. linivcrsit~· of Cincinnati, College of Medicine. 

Cincinnati. Obi''· :vlay I~- 1977 . 

.. i\ Nc\\' ,\pproach to Minimum Toxic Dooc .. 

In: Toxicology Dh·isicm Seminar Series. l!niwrsity of Cincinnati, College of Medicine. 

Cincinnati. Ohio. February ~5. I 976. 

I also have ginn over 50 formal, hut unin\'ited, presentations (e.g., abstracts at the 

scientific lHlllmllllll'etings). 

RESEARCH: RISK ASSESS'\clENT PUBLICATIONS (Selected) 

.\fic/iac/1. flollt.\'1111. Jeri lligginhotham. kiT< ·nun. !leather Burlcigh-Flay<:r. Patricia Nance. 

:\onnan D. Forsberg. !Vlark I.afranconi. John Reichard. 20 I 7. I ipdatc: Mt>dc of action (MO:\l 

i{H·li\'<T tumor;; induced b~ oral exposure tn I A-dioxane. Rq~ulatory Toxicology and 

Pharmacology XX:45-5:'. 

Richard 1\. lkckcr. Vicki Dcllarco . .k'nni!Cr Seed . .lt>cl M. Kronenberg. Bette 1-.kck. Jcnni!Cr 

Forc·nwn. Christine Pall'rmo. Chris Kinnan. Igor LinkoY. Rita Sdweny. :\lie/we! f)ourson. l.ynn 

!I. Pottenger. and 1\·larY K. iVlanibusan. ~017. Quantitatin: \\dght ofc,·idcncc H> as;;c;;s 

conlidcncc in potential modes oi'action. Rq;ulatory Toxicology and Pharmacology. l\(>:20:i 221! . 

. \!iclwcl !!ourson and Raymond Ci York. 2016. i\thancc·s in i\sscssing lngrcdit:m Sali:t\. 

lkgulatnr~ Toxicology and Pharmacology. 79:S II :Z-S I IS . 

. lficlwel /Jourson. fkrnard Ciadagbui. Rod Thompson. l'd\\ard Pllm. and John I.o,,·c. :2016. 

'vlanaging Risks of i\om:anccr I ka!th Effects at I hvardous Waste Sites: 1\ ( 'asc Study l ising the 

Rt:!henee Concentration (!UC) of Trichloroethylene' (rCE). Regulatory Toxicology and 

Phannw.:ology XO: 125- I 33. 

vlichaol 1.. llllur><lll. l'h.ll .. IJ..\BT. FATS, FSIL\ 
79 


27172.074

r.:d \\'.Simon. Yiliang /hu . . \fie/well .. l!ourson. :--:ancy ll. Heck. 2016. Bayesian methods !'c>r 

unccrtaint1· l~lctor application I(\!" deri1·ation ofrdcro:ncc values. Regulatory Toxicc>lo!,!y and 

l'hannacologl SO:'l-2-t. 

!Jour,mJ .. \fie/we!. Chink in. l.y!c. Macintosh. D. I. .. Finn . .Jennifer. Brown. Kathleen. Reid. 

Stephen. !\ 1artinu . .lcancllc. 20 I 6. i\ Case Study nf Potential I Iuman llcalth Impacts lrnm 

Petroleum CokL· Tmnskr Facilities . .Journal nfthc Air & \\'astc l\bnagcmcnt ,\ssoL·iation 1\by. 

DOl: JO.IOXil'l0%22-+7.201h.l IRIJ:l2X. 

:\am:y ll. Beck. Richard:\. lkckc-r. i"ccraja Erraguntla. William H. Farland. Roberta 1 .. Grant. 

Clcorgc Gray. Christopher Kinnan . .ltid) S. l.aKind. R . .lcl'!i'ey l.c\\is.l'atricia 0hmce. Lynn II. 

1\Jtkngcr. Susan 1.. Santos. Stephani.: Shirky. Ted Simon. \fidwc/1. l>ourson. 2016. 

Approaches for describing and communicating m·crallunccnaintl in toxicity charact<:rizatinns: 

l '.S. l'n,·iromncntal Protection :\genc.l's Integrated Risk lnl(mnatilln System (IRIS) as a case 

studY. Fm·ironmentlntcrnational X9~90 (2016) 110~1:2X. (regulatory and safety 

evaluation paper of the year, Society of Toxicology, Regulatory and Safety 

F:valuation Specialty Section) 

(in.:cnhcrg 1\1. Cioldstcin BD, Anderson E.!Jour.lllll.ll.l.andis \\'.North D\\'. 2015. \\'hither 

Risk :\sscssmcnt: 0.'"" Chalkngcs and Opportunities a Third n!'a Century :\Iter the Red Book. 

Risk :\nahsis. :l5( ll ): l95<l-l%S. 

:\alice·. 1' .. 0. Kroner. 1 .. I Iaber and .\/. /)our.wm. 2015. :\sscssing Risks l\> I Iuman lle;llth. In 

Rckrcncc \loduk in lliomcdical Sciences (Online). In-Pres,;. 

Danko\ ic Di\. '\aumann BD. Maier:\. llourso11 ,1/L l.c1·y I.S. 2015. The Scicntilic Basis ol' 

I 'ncLTtainty l:acll>rs l :sed in Sct!ing Occupalii'IHII Exposure l.imits . .I Occup Environ I lyg. 20 I 5 

:--:m 25: I 2 Suppl I :>5-6X 

('ope. Rhian B .. Sam Kacc\\ . . \lie/we/ Duurson. 2015. i\ rcpmductiw. dc,·l'lopmcntal ;md 

nl'urnbchavif)ral study (()I lowing ural (.:Xposure Dftdrabromobisphenol /\on Sprugu\.!-Dawley 

rats. r(l.xicology 32'1 (20 15)-flj 59. 

I >ourson. ,\! .. Reichard. J.. i'iancc. P .. llurlcigh·Fiayer. I 1.. Parker. A .. Vincent. M .. :VlcConncll. 

F.E. 20l.J. \lode of :-tel inn analysis l(>r liver tumors from oral 1.4-dio~ane exposures and 

c1 idence-hascd dose response assessment. Rcgui.Toxicol. !'harm. 6S(J l: 3X7--+0 I. 

Cope'. R .. N:mcc. P .. /)ourson. :'vii .. 1014. "Chapter .J. !Iuman llcalth Risk Assessment or 

Inhaled V!atcrials ... 1:--:· Salem. II.. Kau. S .. cds. Inhalation Tllxieology. 3'" Edition. CRC Press . 

.lulwrg. D.R .. Borglm!'L S.J.. !k-ckcr. IL\ .. Casey.\\' .. llartung.l .. !!olsapplc. M.P .. \!any. 

S.\1.. :Vlihaich. J:.i\1.. Van Dcr Kruak. (i .. \Vade. ivi.G .. Wilktt. C.E .. ;\ndcrson. ivl.E .. Borgert. 

C.J.. Cody, K.K .. IJourltlll. :\/.! ... Fowle. J.R .. (iray. 1 .. 1·:. l.amh. J.C.. Ortcgo.l..S .. Schug. LT .. 

Ionic. C.\1.. Zorrilla. I..M .. Kroner. Cl.l ... l'atterson . .1.. Rinckcl. 1../\ .. .Iones. ll.IC 201-t. 

\\'orkslmp Report. Lessons !.earned. Challenges. and Opportunities: The I iS. Encl<>cri111: 

Disruptor Screening Program. ;\LTLX. ,\!.II'S. :\I.TES. 31:!>3-7X. January. Worbhllp Report 

is'"'" :11 ailablc 1·ia ''lll'll access puhlicalion in ,\I.TEX. 

~lichacll .. lh•<ll'><lll. Ph.D .. llAilT. !-!\IS. FSR:\ 15 
80 


27172.075

Rpsen . .IS: \Vhehon. AI: 1vlc(iuire. ivl.l: Clancy. JL: Bartram!. T: Eaton. A: Patterson. J: /)ounon. 

\I. "ianec. !': ,\cbms. C. 20H. The crmk \IC'IIM chemical spill in Charleston. W.Va . .loumal 

.\ \\'\\';\. Vol. I 06:6:'-7-l. 

Patterson .1.. \laicr :\. Kohrman- Vince·nt ~·1. and H/. Dourson. 2013. Peer consultation <'ll 

rdationship be·tm:en J>,.\C prolilc and toxicit:- or petroleum substanc-es. Reg. Tox and Pham1. 

Volum-e 67: sg6. S93. 

!>o!lrsmJ . . ll.lkcker. R.;\ .. Haber. L.T .. l'ntknter.l..ll..Breureltlt T .. Fenner-Crisp.l'. 201.'\ . 

.. \chancing !Iuman I kalth Risk ;\sscssmcnt: Integrating Recent 1\ch·isory Committee 

l{ccommcntlations. Crit. Rev. Toxicol. 43(6): 467-92 tdoi: IOJ 109/IO-\OX.J44.201.1.li0722~i. 

/Jour.wm .. \! .. Uadagbui. IL Grif!in. S .. Uarabrant. D.ll.. !laws. L.C .. Kirnwn. C. and Tnhyama. 

( ·. 201.\. The: impnrtancc orprobkml(mmtlations in risk assessment:,.\ case study ill\oh·ing 

dio.xin-contaminated soil. Reg. Toxicoi.Pharmcol. 66(~): 20X-216. 

llascgawa R. llirata-Koit:tuni :vl. Dourson .\ IL Parker A. Ono A. IIi rose ;\. 20 I). Sa!'c!) 

assessment or boron by application or new uncertainty i(tctors and their suhdi1 ision. Rcgul. 

l'oxico!. l'harmaco!. 6~: I. I OS-I 1-l. 

!Iaber l.T . .II' Stra\\S(lll .. ·\Maier. Iii·! Baskenille-;\hraham. ;\Parker. .1//. /)our.mn. 2013. 

"\nncanccr Risk ;\ssessment: Principles and Practice· in En,·iromnental and Occupational 

Settings ... In: Hingham. L .. and ll. Cohrssen. cds. /'ul(r 's J(,ximlogy. 6rh l.'dirion. l'olunw 5. 

John Wiley and S<ms Inc. 

\leek. \I.E.. Bolger. ilL Bus . .I.S .. Christopher . .f.. Conoli).IUL Lewis.lU .. I'aoli. <I .. 

Schocnv. R .. !laber.I .. T .. Rosenstein AIL JJour.1on .. \!.!.. 2013. ,\ Framc\\or~ I(Jr Fit-l(lrl'uq)os~ Dose Response 1\ssessmcnt. Rcgul. Toxicol. PhannacoL 6(>(2): n4-40 (d<>i: 

I 0.1 () 1 (J/j.yrtph 2013.03.012. 

\ laicr. r\ .. Kohnnan-Vincent. ivl .. !lcrtzbcrg. R .. !Jour.mn .. \! .. !Iaber, I..T and ,\I! en. B. 2012. 

Critical rc,·iew of dclsc-responsc options J'or F344 rat mammary tumors h>r aery lam ide 

.-\dditional in,;ights ha,;cd on mode of action. Food Chcm. Toxiwl. )0:5. 17(13-1775. 

\ancc P. l'a!tcrson .f. Willis !\. Foronda :-.:. /)ou/'1'1111 .\/. 2012. lltnnan I kalth Risks !!·om 

\kn:ury Fxposun: ii·om Broken Com1xKt Fluorescent Lamps. Reg. Tn.x. !'harm: (•2!3): 54:>552. 

l'<lttc:rson .f. ivlaicr :'\. K.ohnnan- Vincent \!. /)ours on .\11 .. 2012. Peer consultation on relationship 

hct\\cen l'i\C prolik and toxicity of pctwlcum substances. Rcgul. To.xicol. Pharmm:ol: pii: S0~73-2.'\00( 1 ~ )0022-l-3. 

Rickr ( ·v. /)ourson .\I. I krt!hcrg RC. Mumtaz MM. Price PS. Simmons JF. 2012. ln..:orporating 

nc>nchemical strcssors into cumulati1·c risk assessments. T<•xicol Sci: 127( 1 ): I 0-7. 

Rhomberg I.R . .II·: ( ioodman. I.T !Iaber .. \/ /)ou!'.I'0/1. ii'IF ,\ndcrscn . .IL Klaunig. B \leek. I'S 

Price. RO \let 'lei ian. S\,1 ( 'ohcn. 20 I I. l.incar low-dose• c"trapolation l(>r nnncanccr health 

dfccts is the c:-;ception. nol the ruk. Critical Rc1·it:ws in Toxicolog:: .J l (I): l-19. 

!Jour.1011. ,\/and llabc::r. 1 .. 20 I 0. Linear l.oi\·-Dosc Extrapolation. In: Cancer Risk Assessment. 

( 'hing-llung llsu and Todd Stedc!(mi. ed . .ll>hn Wiley &Sons. 

/)ourwm . .\!. L.. M.J. K.olmmm-Vincent. ll.C Allen and \V.S. C\1in. 20 I 0. Dose Response 

i\:-.scssmcnt li'llln l'llcds ol' !\cute Exposure to Methyllso!hiocyanate (iviiTCl. Reg. Toxicol. 

Phannacol: 5St2): !XI-ISS. r\1ailahkon line. 

\lichad 1.. l.lour>o!L Ph.D .. I Mill. FAT~. FSR,\ 16 
81 


27172.076

/Jour.'""· .\/. 201 U. l'-Shapcd Dos<:-rcsponsc Cun·cs: Implications for Risk Charact<:rizatinn of 

F,;scntial Ucmcnts and ( Hhcr Chemicals . .1. ofTox. ami Em. I kalth. Part :'\. 7.'\ ( 2 ). I X 1-1 X!>. 

Cain.\\' ... \!.! .. !Jourson. ~U. Kolmnan-\'inccnt and B.C. Allen. 2010. !Iuman Chcmoscnson 

Perception nf :\let h) lls<~thiocyanagc: Odt>r and Chcmesthcsi. Rt:g. l'oxicol. :\nd Phannacol: . 

5SCl: In-IRO. ,'\,ailabkonlinc. 

('ham hers A. Kre\\ski D. Birkell N. Plunkt:ll ! .. !lcrtzhcn.! R. Dan..:ciscn R. t\uuctt I'J. Starr Tit 

llakcr S. !Jaurson.\1. Jnnc·s P. Keen Cl.. iVkck B. Sehocr1: R. Slob\\'. 2010.'7\n L'~posurt:­

rcsponsc cun c !(lr copper excess and dclieiency . .I loxicoll'nviron l kalth !l ( 'rit Rc,·. 20 I 0 

Oct:J:l(7-l0: 546-78. 

( iadagbui. B: i\1aicr. .\!: /)ourson. :VI: Parker.:\: Willis . .'\: Christopher . .11': !licks.!.: Ramasany. 

S: Rohc:rts. S:\1. 20 I 0. Dcri,·cd Rc!i:rencc• Doses (Ril)s) l(lr the Lm·ironmcntal Dcgradatcs of the 

I krbicides J\lachlor and Acctochlor: Result:< of an Independent Expert l'and Dcliberatitm. 

l{cgu!atory Toxicolng~ and Pharmacology 57:n0-2~-+. 

!lasct!<l\\a R.!IK 1\lutsu~o .. Iff. /)oursou. ;\Parker. LM S\\ccncv. ;\Nishikawa. 1\1 Yoshida .. '\ 

Ono.~·\ llirosc. 2010. Proposal ofnc\\ uncertain!: litctor applicaiiontt> derive tolerable daily 

intake. Regul. Toxicol. l'harnHKl>L 58(2): 237-2-+2. 

'\ancc. 1' .. Kroner. 0 .. I Iaber. 1 .. und /)ourson ,\/. 20 I 0. \sscssmg Risks to I Iuman I kalth. ln. 

The Occupationall'nvirnnmcnt: Its h·aluation. Control and !'vlanagcment. 3'<~ Ld .. \111.\ Press. 

D. ,\nna. cd. 

/!tao. (j.J .. l!ahcr. 1.. Kohrman- Vincent. i\1.. Nance. l' .. Dourwm . . \ /. 20 l 0. QuantitatiYc 

modeling in noncancer risk assessment. In: Quantitatin: Modeling in ToxicologY. John \Vi ley. 

K. Kri~lman and \I .F. Amkrson. ed. 

/)ourson .\!.. lknzb.:rg. R .. i\lkn.IL !Iaber. !...Parker.:\ .. Kroner. 0 .. :\laic:r. r\. and 

Kohnnan. ;\t 2008. h·idcncc-Bascd Dose Rcspnns.: ,\sscssmcnt for Thyroid Tumorigcn.:sis 

ti·om :\cr: !amide. Regulatory Toxko!og: and Phannacology 5~ COOS) 2(>.f--2R<J. 

Wulkn\\cbcr. :\:Kroner. 0: Knhnnan. J\1: Maier. A: /)our.loJJ .. \!: Rak, .'\:Wexler. P: 

TomljatHllic. C. 2008. Resources fnr global risk assessment: The International Toxicity 

Estimates l(,r Risk tirlc'Rl and Risk ln!(mnation bchangc tRiskll-:) databases. Toxicol. 1\ppl. 

l'hannacol. 23~: .f). -5.'\. 

I lay,;. Si\·1: :\yl\\ard. Ll .. La Kind . .IS: Bands. \-1.1: Barton. llr\: Boogaard. 1'.1: Brunk. C: Di/io. 

S: /)ourson. \!:Goldstein. DA: l.ipseomb . .1: Kilpatrick. iv!E: Krc,1ski. D: Krishnan. K: 

\ 1ordherg. i'vl: Okino. !\I: Tan. YM: Viau. C: Yager. JW. 200X. (iuidclinc•s l(lr the dc•rinttion of 

Binmnnitoring J-:qui1alents: report 1i·01n the !liomonitoring FquiYaknts Expert Workshop. Rcgul 

Tosicoll'hurmaeol. ~I(~ Suppl):S-~-15. 

!Jounm1 .. \!./ __ and Parker. ;\. 2007. Past and Future l 'sc or lkfintlt .'\;;stllllptions and 

l inccrtainty Factors: Dcl:mlt Assumptions. \lisundcrst;utdings. and New Com:cpts. llum b:ol 

J{isk ;\ssL·ss. 13( I ):82-XX. 

llasL'ga\\a R. llirata-Koizumi M. f)our.wm .\!.Parker 1\. llin>s.: ;\.Nakai S. Kamala[. Ema \,1. 

2007. Pediatric susccptihilit: to I & industrial chemicals:;\ comparathc analysis of' newborn with 

\tichal'i L. llt>ur>ntL Ph.D .. ll:\llT. F,·\TS. rsR:\ 17 
82 


27172.077

)Oung animals. Rcgull<•xicnl !'harmacol. 47<3 >:2%-.107. (Risk assessment papH of the 

year, Society of Toxicology, Risk Assessment Specialty Section) 

Stedeford T. Zhor J, Oourson ML. Banasik M. Hsu CH. 2007. The Application of 

Non-Default Uncertainty Factors in the U.S. EPA's Integrated Risk Information 

System (IRIS). Part I: UF(L). UF(Sl. and "Other Uncertainty Factors". J 

Environ Sci Health C Environ Carcinog Ecotoxicol Rev. 25(3) :245-79. 

Stnn. B.R .. :Vl. Solioz. D. Krcwski. 1'. i\g!,!e!l. T-C :\w. S. Baker. K. Crump. H llour.wm. 1.. 

llaher. R. llertzberg-. C.L. Kc..:n. B. ~k..:k. L. Rudenko. R. Schneny. W. Slotll. T. Starr. 2007. 

(·upper and !Iuman llcalth: Biochemistry. (icnetics and Strategies for Modeling Dose-Respome 

f{ehitionships . .J. To:xicnl. and Fmiron.lkalth. Part B. I0(."\):1S7-222. 

Oourson .\! aml D. Drinan. 200(>. Scnsiti\·c l'npulation> and Risk Ass-essment. In: 

!iJximkinelics in Risk :lssessme!/1. Taylor and Francis Publishers. J.C. l.ipscomb anLl E.V. 

Ohanian. his. lnl(mna health care. Nt'w York. Pp. 251-210. 

(iada!.!buL B.K .. L.T. !Iaber and JU.. /)ourson. 2006. Chcmit:al Risk 1\ssessment as t 'sed in 

Scttir]g Rcgulatnry I .cn.:b or Standards. Chap. 3.3.1 in TransJ(mning Sustainability Stratt'gy into 

!\t:tit>n: The Chemicallndustrv. edited b' Beth llclon: Marianne Lines. and Dickscnlnn:ril. llobo~en. 0;.1: John Wiky &.Sons. Inc." 

Schoeny, R. L. Haber. and M. Dour son. 2006. Data considerations for 

regulation of water contaminants. Toxicology_ 221 (2-3): 217-224. 

Zhao, 0 i yu , M. Dour son and B. Gadagbu i. 2006. A Review of the Reference 

Dose (RfD) for Chlorpyrifos. Reg. Toxicol. Pharmacol. 44:111-124. 

Dolan. D .. B. Naumann. E. Sargent . ..\. Maier. .\f. /)our.wm. 2005. Aprlication nfth.: threshold 

oftoxiLological concern concept to pharmaecuticalmanu!hcturing operations. Rc!,!. Toxicol. 

Pharmacol. ·B: 1-9. 

FiLids. C ... \/./ .. !lour1m1. ;\nd J. llontk. 200). lodinc-ddicicnt n-gctarians: ;\hypothetical 

pcrchl<>ratc-susccptihk populatinrl".' Reg. Tox. Pharnmcol. 42( I ):37-46. 

Lakind. Judy. Robert Brent . . \fie/we/ f)oursrm. Sam K<1cc·w. Oidcon Korc'n. Baba~ahch 

Soml\\anc. :\nita Tarzian. Kmhk~n l 'hi. 2005. Human \Iii~ Biomonitnring Datn: Interpretation 

and Ri~k ;\sscssment Issues . .Journal nfToxicology and Fn,·ironmentalllc;llth. 1·nl. (•X. no. 20. 

Zhao.() .. B. Gadagbui and .\f. llourson 2005. l.nwer birth \\·eight as a critical .::!Teet of 

Ch!orpyri!{>s: ;\ cnmpari,;(lll of human and animal data. Reg. Toxicol. Pharmacol. ,l:::!::i:i-6:1. 

lJour\"rJII .. \!.. U. Charnley. It Schcuplcin and M. Barkhurst. 2004. Chemicals and Dru!ls Risk 

;\sscssmcnt: Dillert?ntial Scnsiti1·ity of Children and ;\dults to Ch<.!micnl To:-.icity. !Iuman and 

l'.<:ol. Rbk Assessment. I 0:21-27. 

/han.(): Kan. II: !Iaber. L: Chen. B: /)ourso/1, .H. 2004. !\dv;mcc in Do:<<.!-Rt:sronsc 

Anal) sis. ("hines<? .1. Pharmacology and Tnxicnlogy. IS: 152-160. Chinese edition. 

\tichacl t.. Dnur,,>n. Ph.D .. lli\lll. h\ IS. J.'SIV\ I~ 
83 


27172.078

Palt~r,;on. L PJ. I lakkinc·n. P.\1. :-lan~c .. \/./ .. !Jnurson. ll..l. Klau~nherg. 200~. Riot Control 

,\gc·nts: Issues in Toxicology. Sakty. and I k;tlth by Eugc'lll' J. ( llajos (hlitor). W Stopl(1rd 

( hlitor). Chapter I 3: .·\n i\pproach hw ,\ssessing and Characterizing Risk from Us~ oC Riot 

( ·ontrol :\gents. Page':< 15'1-271. 

Strawson . .1 .. Q. /.hao and .If. /)ourson. 200~. Rdcrcncc Dose lt1r Perchlorate hased <'ll lh) roid 

I hmnonc Change in Prcgna111 \\"om~n as the Critical Ei'lcct. R~g. !'ox. and !'harm. 3'1:44-65. 

/.hno. Q .. K. llai-Dong. L. !Iaber. C. Bing-I kng and .\/. /)ours on 2004. Recent lkvclopmcnt 

in Chemical Risk :\s:;cssmcnt. Chin. J. Phannacol. Toxicol. 18(2 ): 152-160. 

lJourson . . \/.and .1. Patterson. 2003. ;\ 20- Year Perspective <llllhc l)cq;fopm.:nt oi'Non-Canccr 

Ri,;k Asscssmcrlt \kthods. Special Issue oft he Journal of Human and Ecological Risk 

.\sscssmcnt Conunc:morating 20'" Anniversary of the NRC's Red Book on Risk ,\sscssment and 

Risk :vlanagcnwnt. Human and !'eological Risk Assessment. 9: 12YJ-1::'52. 

!Jour.,oll .. \I. and Magcd Younes. 2002. Evolution In Nnncancc·r Risk Assessment- Current 

Practice. Conll"<l\·crsics. 1\nd Challenges. Comments On Toxicology. 7f)-(,):."l'i9-414. 

l>our.1m1 . .I!.L. Ci. Charnley and R. Scheupkitl. 2002. Dill'crcntial Scnsiti,ity Of Children ;\nd 

,\dulls To Chemical To:-;icity: II. Risk 1\ml Regulation. Regulatory Toxkology ~md 

l'lmnnacolugy. <S:44R-467. 

1-:idcr. L .. !\.. Poirier. :11. /!our,ml . .1. Kkincr. B. :\.lilcsnn. II. Nordmann. A. Ren~Yick. \\".Slob. 

K. \\"alton and ( i. Wurtzcn. 2002. Mathematical 'vloddim! and Quantitative 1\·kthods. Food 

and Chemical Toxicolog\. 40:28.>-."\2(1. -

llabcr.I .. T .. ,\. :\laier.I'.R. (icntry.ll..l. C'h:wcll and .If./ .. /)nurson. 2002. Genetic 

l'olynrPrphisms In 1\sscssing lnterindividuai Variability In lkli\crcd Dose. Regulatory 

i<1X i''(>logy and l'harmacolng'. 35:177-197. 

Schc:uplcin. R .. CJ. Charnley and Ml.. Dour.HIII. 2002. Dirti:n:ntial Sensitivity OfChildn;n and 

i\dults To Chemical Toxicity: I. lliologicalllasis. Rcgulatnry Toxicology ami PharmacologY. 

]5: 429-447. 

:\ndcrson 1' . .-\ .. . \I. l!ourso11. J. Unrim: . .1. Shccshka. E. \lurk in. and .1. Stober. :wo~. Frame\\ork 

and c·ase studies. In: Special issue. ( 'mnparati\c dictar~ risk: Balancl.' the risk and bcnclits or 

ilsh consumption. Comments on Tnxic(1logy. X(~-6):4~ 1-502. July-lkccmb.:r. 

f!ourson 1/.. !'. !'rice. and .1. l inrinc. 2002. ll.:alth risks from eating contaminated fish. ln: 

Special issue. Comparative dictar) risk: Balance the risk and benefits pf fish wnsumption. 

CommL'IllS on To.,icology. ~( 4-6):399-420 . .luly-Dcccmhcr. 

/)oursnn . . \/.! ... ·\.E. Wullcn\\chl.'r. Kenneth A. Poirier. 2001. l!nccrtaintics in the Rcli:rcnec 

DPs<: lt>r \lcthylmcn:ur~. Ncuwlpxicology. 22 (5) pp. 677-()89. 

/)ourson . . \/ .. \1. ,\ndcrscn.l"" l'rdrcich and .1. ~1m:gregnr. 2001. !ising !Iuman Data to l'n.11cct 

the l'uhlk',; llcalth. Reg. Toxicol. Plrannacol. Vol. 3.1. No.2. Apr 2001. pp. 2.14-256 . 

.\lichad 1 .. !low·""'· l'h.D .. !),\Ill. lArs. FSRi\ 
84 


27172.079

!Iaber. L.T .. ;\. ivlaicr. ()./.hao . .I.S. Dollarhide. R.E. Savage and .\f.L Oour.1·on. 1001. 

Applications oPvkchanisti<: Data in Risk Assessment-- The Past. Present. am! Fllturc. 

Tn:\it:()logical Sciences. 61 :.'12-39. 

llah:r. I .. 1.. I lollarhidc . .I.S.. :Vlait:r. A .. and 1 )ours on. \ 1.1 .. 100 I. Noncam:cr Risk ,\sscssmcnt: 

Principks and Practice in !·:m ironnwntal and Occupational Settings. In: Patty's Toxiwlogy. Firth 

edition. Bingham. L.. Cohrsscn. and C. II. l'owdl. cd. Wiley and Son:;. Inc. 

'.kcJ... B ... ·\. Renwick. F. 0h<1nian .. \/. /Jourson. B. Lake. ll. Naumann and V. Vu. 2001. 

Guidelines For •\pplication or compound Spccilic .\djustmcnt Factors (CSAF) In 

Dosc•Conccntration Response :\sscssment. Commctlt:< Onloxicoh>gy. 7(5-6):575-5')0. 

!Iaber. L.l .. L l:rdrcich. Ci.L Diamond. :\.:vi. Maict'. R. Ratncy. (). /hao and .\fL. Doursm1. 

~000. !Iazard ldc•ntili<:ation i\nd Dosc-Rcs1wns~ Of lnhalt:d Nickd Soluble Salts. Reg. Toe-;_ 

Pharmacol. _1 I :21 0-2~0. 

I Iaber. I .. T .. ( i.l.. Diarntmd. (i.L. ().Zhao. L. l'rdreich and,\/. L. [)ourson. 1000. lla1ard 

!dcmilication ;\nd Do~c-R.:sponsc or ln).!csted Nickel Soluble Salts. Reg. lox. Pharmacol. 

31:2~1-2-11. 

l.akind. J.S.. \!.!:. (iinc\an. D.(). Naiman. ,\.C. .lames. !L\. Jenkins. J/.L. Dourso11. S.P. Felter. 

C.(i. Graves and R.Ci. Tardiff. !999. Distribution of Exposure Concentrations and Doses !i1r 

Con:;titucnts of F111 ironmc•ntal Tobacco Smoke. In: Risk ;\nal~ sis. 19(3 ):375-390. 

I cuschlt:r. !..K .. MI.. /)our.\'1!11. \\'.i\1. Stiteler. P. l\kclurc and l I. Tully. I 'l99. I kalth risk 

abt>l c the rclcrcm:c dose li.n· multiple chemicals. Reg. Toxicol. And l'hannacnl. 30:S 19-s:zr,. 

/hno. C) .. .1. llnrinc and .1/. nours011. 1999. Replacing the Dclitult Values Of Ill \\'ith DataDcrilcd Values: i\ Cmnparison ofT11o Dilkrcnt Data lkriwd Uncertainty !:actors ror Boron. 

!Iuman and Ecological Risk Assessment. 5( 5 ):'l73-983. 

llourson .\!.! ... A :'\bier. B. Meek.;\ Rt:1111ick. E. Ohanian and K. Poirit:r. l'l'JS. Re-evaluation 

oJ'to~iwkinctics l(lr data-dcri\'cd uncertainty f~Ktors. 11iolo)!ical Trace Elcmcm research. M1( 1-

~ ): -15.1--16.'. 

l-eiter. S.l'. and J/. llourson. I 'l<JS. The Inexact Science or Risk ;\sscssmcnt (and Implications 

for Risk i'vlanagc·mcnt 1. !Iuman and Fro I. Risk Assessment. 2:2-15-251. 

Swartout. .1 .. 1'. Price .. II. Dour.wm. II. Carlson-Lynch and R. Keenan. 1998. :\ Probabilistic 

Framc\lork J(>r the Rc!Crcncc Dose. Risk .-\nalysis. I XU l:271-~X2. 

/Jour\im . .If./... L K. T<?uschlcr. P.R. Durkin. and \V.M. Stiteler. !997. Categorical Regression or 

lo~icity Data:,\ Case Study using i\ldicarb. Reg. Toxicol. Phannacol. 25:121-!29. 

/Jourson. H f .. and S.l'. Felter. 1997. Route-to-route cxtrapolatinn of the toxic pPtCilC\' of MTBE. 

Risk .\nal. 15:-1:;-57. 

.\lichact I. Dour'""· rh.tL fl.\lrl. 1-'ATS. FSR;\ 20 
85 


27172.080

1\''Yl'S. W.K ... \/./ .. /Jourson . .1. l'at!~rson. !I.A. lilson. W.l'. Selle. R.C. :vtncphail. .<\.;\. l.i and 

.1.1.. O'Dnnoghu~. 19'J7. Fund and Applied Tn~icology. El':\'s Ncurot\l~icity Risk /\sscssm~nt 

( iuiddincs . .JO C~ ): pp.l7~-1 R.J. 

l·cltcr. S.l' ... \/. liuurwm and J. l'atlcrsnn. !997. ( 'hnpter 2: .<\ssc>sing Risks to !Iuman !lcalth 

from Chemicals in the 1-'11' ironment. In: llandhook of l·:m ironmcntal Risk ,.\ssc,;smcnt & 

\·lanagcment. 1'. Calol\. hi. 1\hH:k\\"cll Science. Oxl\wd. 9- :'3. 

Fdtcr. S.l'. and .\/.L !lour.'illl. 1997. llcxa,·alent Chwmium Contaminated Soils: Options l(lr 

Risk .-\sscssmcnt and Risk \lanagcment. Reg. lox. Phannacol. 25:.J.l-.'i9. 

Price. 1' .. R. Keenan . .1. S\\Urtout. C. Clillis. II. Carl.son-l.ynch and,\[ /)ourso/1. 1997. :\n 

.-\pprnach 1\n· \·lodcling Non cancer Dose Responses'' ith an Emphasis on\ lncertainty. Risk 

.-\nal. 17 (.J):.J27-.J37. (Risk assessment paper of the year, Society of Toxicology, 

Risk Assessment Specialty Sl•ction) 

Dour., on . . \ i 1 ... S.l'. Felter. and D. Rnhinson. 19W>. h·oiution or science-based uncertain!' 

bctors in nonc·ancer risk assessment. Rcgulatnry Tnxicol. l'hannacol. 2.J: l OR-120. -

Ciunancc. .1.1. .. ,\/.1.. Oourso11 and R.C ·. llci'l/bcn!. !996. Noncanccr risk as:;cssmcnt: Present 

and emerging i,;sucs. In: Toxicology and risk as:;~ssment: Principles. methods. and applications . 

. \.\1. Fan and L.W. Chang (editors). i'vlarcd Dekker. New York. New York. Pages 293-:>09. 

!lour.1on .. \f.! .. and F.C. l.tL !995. Sal(:ty-'Risk assessment nrchemicals compared l(lr dilfcn.:nt 

expert groups. llinmcdical and l:nvirnnmcntal Scit:nccs. S: 1-1 ~-

/)our, on. H /. .. t <N.J. 'Vkthodolnc\ l(lr l'stahlishin~r Oral RL'i\:rcncc Doses ( R!l)s). In: Risk 

;\ss<:s>nH.:nt nl' bsentia1 !·:lcmcnts:\\'. 1\krtz. C.O. /\bcrnatln·. and S.S. Olin (editors). I LSI Press 

\\ ashington. D.C. l'ag.:s 51-61. · 

.\bcrnathy. C.O. and .Ill.. Oourso11. I99.J.Dcri,ation ofth.:: Inorganic ;\rscnic RL'i\:rcnec Dose. 

In: 1\rscnic· 1::-;pnsurc and llealth. \V.R. Chappell. C.O. ;\bcrnath:, and C.R. Cothern i<:ds.l. 

Sckncc and Tcchnolog; Lc·tters. Nortln,ood. England. Pages: 2'l5-303. 

liour.\fm . .If. f... 1993. The Chromium RL'i\:rcnce Doses (RIDs). In: Risk :\sscssmcnt or 

Essential Lkmcnts. W. 'lkrv. C.O. ;\bcrnathy. and S.S. Olin (ctlilors). I LSI Press. \Vashingtnn. 

D.C. Pages 207-212. 

Heck. ll.D .. R.B. Conolh . . \U .. {)ourson. D. Utah. D.llattis. C. Kinum:l. ami S.C. Lewis. l<J<JJ. 

lmprm·cmcnts in quantit"ati\ e twncancer risk as,;cssmcnt. Fundamental <lnd ;\pplkd lox. 20: 1-

l.J. 

llcrtz.hcrg. R.( ·.and.\/./.. nourson. I 'Jli.l. l ising categorical regression instead of a NO!\I'L to 

charactl'rizc a toxicologist's judgment in noncanccr risk assessment. In: Toxicology or C 'hcmical 

tvlisturcs: Case Studies. Mechanisms. am! No'cl Approaches. R.S.H. Yang (editor). Academic 

PrL·ss. San 1 )it..'go. 

nmrrso11. ,\/.!... KnauL l..r\. and J.C. S\\artout. 1992. On relhcnce dPse (RID) and its 

l ndcrlying Toxicity DatabaO'c'. ltl'iicolngy and Industrial Ilea It h. 8t3 J: 171-1 X<J. 

1-arlaml. \\'. and .\1. L nourwn, I 992. Noncanc.:r health endpoints: ;\pproachcs to quantitati,·c 

risk asscs,;nll:nt. In: Cl>tnparati,·c Fnvin>nmcntal Risk ,\ssl.'ssmcnt. R. CothL'rn (Editor). l.e\\is 

l'uhliO'IWrO'. lloca Raton. !;lorida. Pages S7 -I 06. 

21 
86 


27172.081

Lu. I·.C. ami.\/. /.. Dourson 1992. Sa!Cty;Risk assessment of chemicals "Principles. Prnccdurc,; 

and Fxampks. J. Occupational Medicine and Toxicology. l ( 4 ):3::! 1-.";:15. 

!Jourson . .\II ... Stern. 1\ .. ( iriflin. S .. and K. Baiky. 1991. lmp<lCt ,,r Risk-related Conc..:rns on 

l .S. En,·ironmcntal Protection ,\Qcnc' Program,;. In: l'roccedin!.!S ti·nm Ad1·anccd Research 

WPrbhnp on nitrate contaminatii)n: cxpost;rc. wnscqucnccs aml control. I. Bogardi and ltD. 

Ku1.dka (editors). l\Prth ;\tlantic Treaty Organi'lllion (Ni\10) !\SI Series. Vol. (i ~0. SpringerVerlag. Berlin. I kidelbcrg. l'ag<"S: -l77--IX7. 

/)ounon. ,\/, /.. and C.T. DeRosa. 199 I. l inccrtaillly !'actors in l·:stablishing "Safe" l.c1ds of 

h:posun:. In: Statistics in Toxicology. Kn:11ski ami Franklin (cdit<ll'S). Gordon and Breach 

Scil'nce Publishers. \ic1' Yorh. 

Ooun11n .\ /. !.. I tJCJI. 01 l'n ic11 or FP !\'s ()uantitatil·~ \ion cancer Guidelines. In: Proceedings of 

the· X4th ,\nnual !\lectin!! and Exhibition. :\ir and \\'ast~ :VIana;:cmcnt 1\ss<>dation. Vancouver. 

British Columbia. June ~16-21. -

Dourson .. \!.! .. aml.I.'IL ('lark. 1'>90. Fish consumption advisories: Towards a I 'nilicd. 

Scientilically-crcdiblc Approach. Regulatory Toxicology and Pharnulcology. 12: I 6l-17X . 

.larahck. i\.\L \knachc. !\Hi .. Overton .. l.! 1.. /)oursun .. \f.L. and FJ. \filler. !990. The I :.s. 

hlYironm.:mal Protcc!ion i\g~ncy's Inhalation RID !\Jethodology: Risk Assessment for r\ir 

loxics. Toxicology and lndustrialllcalth. 6(5):279-301. 

!kl{osa. C.l .. Oourson. .\/.!...and R. Osborne. 1989. Risk :\sscssm<:nl lnitiativ<:s ll.H· 

\ioncanccr 1-:ndpoints: Implications l(w Risk Charackri/ation or Chemical il·lixturcs. loxicolng} 

and lndustrialllcalth. 5:X05-li:Z-l . 

.larahck .. c\.\l..l\knachc. !vf.(L 01erton. J.IL Ooursrm . .1/.L. and F..l. Miller. llJXCJ. Inhalation 

refcorcnu: dose ( R Jl)i ): .c\n application or imcrspeci<:s dosimetry modeling t(u· risk assessment of 

insoluhil" particles. lkalth !'hysil">. )7:177-183. 

Barncs.l).(i .. and .Ill .. lJuur.wm. 191\S. Reference Dnsc (R!Di: Dcscriptinn and usc in health 

rish asscssmcm,;. Regulatory roxicology and J>hannacolo!,!y. 8:-l 71-4X6. 

Jarabe•k. 1\.".L Do/11'.1011 .. \f./ ... and LE. Erdrl.'ich. 1987. Inhalation rclcrcncL' d<bC (RJl)i): 

Concl.'pt and issu~s rclate·d to risk assessment of toxic air pPilulants. In: Prm:ccdinp of the 

:\PC:\ Spccialt) Conlcrcncl' on Regulator: 1\pproachcs l<1r Control of i\ir Pollutants. h:bruar) 

17-20. ,\tlanta. ( icoqoia. Pages 24 7-261. 

Stara. J.F .. RJ.I·. Bruins .. \// .. /Jounon. LS. Lrdrckh. R.C. I !cruhcrg. P.R. Durkin and W.F. 

Pcpelkn. J 9S7. ltisk a:;,;cssmcnt is a developing science: 1\ppmachcs to impnwc cntluatinn of 

sinl!ic chemicals and chemical mixtures. In: \kthoJs for ;\sscssin\! the E!Tects of Mixtures of 

Chemicals. V.lt Vouk. (i.C. Butler. i\.C. I lpton. D.V. Parke· and <c. i\shl.'r. I'LL 19~7. 

SCOPE. pp 719-743. 

/Jounon .\f. f... I 9X6. l\cw approaches in the dcriYation nf acccptahh: daily intake (,\D!). 

( 'omm<.'nts on Tnximlogy. I ( 1 ):35-4S. 

lJounrm .. \I !... R. C. I !crt/here. It f lartunQ. and K. Blackburn. I 1)R5. Non: I ilkthods l(,r the 

btimali\ln of :\cccplablc Dail)~lntakc. Toxicology and Industrial Healih. 1 ( 4 ):~3--l I. 

\1icha::ll .. llour<oll. l'h.D .. ll.-\11 l. FA IS. FSR:\ 
87 


27172.082

Stara . .I.F .. I krllhcrg. ICC.. Bruins. !U.F .. /)our\1!11. HJ .. Durkin. R.P .. Erdr~ich. L.S. and \\".E. 

Pcpdk''· I 9S~. Approaches to risk a,;sc,;smcnts of chcmicalmi:-;turcs. In: Karger Continuing 

Education Series Vol. X: Sakty Regulation of Chemicals in the· 1 :.s.,\ .. S. Karger i\Ci. ll;JScl. 

nour.1o11. H f.. and J. F. Star;t. I <JXJ. Regulatory l!istory and Fxpcrim..-mal Support of 

l-nccrtainty SafCty) Factor~, Rl'gulatory Toxicol(lg~ and Pharmacolug.y, 3:224-2~N. 

I.c·c. S.D ... 1/, L Uoursm1. D. \lukerjce . .1. F. Stara am! .I. Ka11cki. 1'!83. ;\sscssmcnt of 

Benzene I lealth E!Tccts in .'\mbknt \Vater. In: Carcinogcnicit} and Toxicity of lkn;cne. ~L\. 

~·khlman (Editor). Princl'tnn Sci<:ntilic l'uhlishc•r. Inc. Princeton. NJ. Pages 91-126. 

Stara . .1. F .. D. i\tukcrjcc. R. rvk(iaughy. !'.Durkin and .\f. L /)our.wn. I 9~3. The Curr.:nt ( :sc of Stu<lics on Pmmotcrs and Co-carcinogens in t)um1titatin~ Risk :\sscs~mcnt. EnYironmcntal 

llcalth Pc:rspcctin·s. ~O:.\S9-.\6X. 

JJourso11. \1. Land E. J. tl'Flahcrty. 1982. Relationship of Lung Adenoma Prevalence and 

l irowth Rate to .'\cute 1 :reth<mc Dose and Targd Cdl Number. Journal of the 1'-:ational Canec·r 

Institute•. !>'!(.+ J:X5l-X57. 

U'Fiah..:rty. L. J. and.\!.! .. 1Jour.1o11. l '!82. Rcbtionship he! ween Urethane Dose Rate and 

,\dc·noma Latency: l~ek\·ancc of tumor growth rate and wrgct cell number. Journal of the 

~ational ( '<mcer lmtitut<?. 69( ~ ):859-X65. 

Stant. J. F ... \1. / .. /)our.lo/1 and C. T. DeRosa. 19R I. Water Quality Criteria: methodology and 

applications. In: Conkn:ncc Proceedings in Fm·ironmcntal Risk ;\sscssmcnt: IIO\\ :\cw 

!{cgulations \\'ill:\!Tcct the Utility Industry. l'lectric Pmwr Research lnstitul<:. Palo ,\Ito. 

( 'alifornia. 

/loun011 . . \!. ! .. and ('. S. llaxtcr. I <)S I. Reduced incidence and ~mm th rate of urethane induced 

lung adcll<'mas in aging adult strain,\ mice. Tnxknlogy. 20:165:172. 

:'-Janson . .1. \1.. .II.! .. J)ourson and C. C. Smith. 1977. El'i'ccts of(\tosine :\rabinosidc on i11 

1·im ami ill \'itro \louse Limb l)c,dopmcnt. In Vitro. 13(7):~3~. · 

I hmc also co-authored \\ell over II HI documents i(>r the EP1\. TERA and others that address 

either ri,;k nss.:ssmcnb liH· spccilic chemicals. or risk nssessment methods. and han: additional 

published mmn1s<:ripts that arc not listc·d here. I have also written tlm:c stories on inkgrating 

scic·ncc· and Bihlicaltcxt: Messiah·.,. Star. The /Jcginning. and T/w l.inm ( '!01/1s. 

RESEARCH: COMMENTARIES (Selected) 

Thomas G. Osimitz, Michael L. Oourson. A. Wallace Hayes, and Sam Kacew. 2014. 

Crystallographic Analysis and Mimicking of Estradiol Binding: Interpretation 

and Specu I at ion. Env i ronmenta I He a I th Perspectives. Vo I ume 122 (number 4). 

Apri I 2014. page A 91. 

Gai I Charnley. Thomas Cluderay, Michael Oourson George Gray, Tom Roberts. The 

Perchlorate Debate: Is the Chemical Worth Regulating. 2011 The Environmental 

Forum. Nov/Dec. Vo I. 28 (6). page 46-53. 

Haber. L. . Maier, A. . and Dour son !rf 2006. Using Best Science in Cancer Risk 

Assessment, Editorial. Hum Ecol Risk Assess 12(1) .1-8. 

\lichac'i t.. l><>ur,on. Ph.D .. DAB t'. Fi\lS. FSR,\ ,, 

-·' 
88 


27172.083

Strawson, J., M Dourson 0. Zhao. 2005. The NAS Perchlorate Review: Is the 

RfD Acceptable? 2005. Env. Health Perspect 113(11) :A729-30: Nov. Author 

rep I y A730-2. 

'aumann. ll .. ll. i\.Jeek . . \fL. f)ourson. and E. Ohanian. 2005. The Futun: oiThemical Spccilic 

:\djustmem Factors in Risk :\sscssment. Risk Policy Rc·port. 12(J l ): 1-1. 

Strawson. J.. 0. Zhao and M Dourson. 2004. Response to Letter to the 

Editor. "Critical Effect of Perchlorate on Neonates is Iodide Uptake 

Inhibition". Reg Tox Pharmacal. 40:378-379 

!Joursmr .. \!./ .. 19W>. hlitorial: l :ncertainl' Fadtu·s in "oneancer Risk ;\:;:;essrnent. Reg. To;;. 

m1d Phannaeol. ~-I ... \nick ,o. 0 II:'. p. I 07. 

/)ounoll .. \f. L 1995. llo\\ RcuulatntY Al.!cncics Vic11 Biological !'!Teets t•f [,,,,, Le1 d 

!exposures. BU.I.!c :\ciiSkt!cJ~ -1( I ):7. • 

/Jourson .\!./ .. nnJ \\'. Jnrdan. l9R9. lltm "Saii:" Is the <imundwatcr that :\mcricans Drink'! 

(iround \Vat..:r i\lonitnring Rcl'iew. !'all bue. <J:n-7-1. 

fJourso!l. H L R. C. llertzberg and .1. 1'. Stara. 19ll6. Letters to the Editor. Fundamental and 

:\pplicd To:dwlng). 6:182-IS-l. 

O'Fiahcrt;.. E. J. aml.\1. L Dourson. 1983. A Reply to Letter to th0 Editor "Cell~ oi'Origin nl' 

Lung Tumnrs in \lice. Journal ol'thc National Cancer Institute. 70(6):991-992. 

SERVICE: SCIENTIFIC SESSIO:'>IS CIIAIREil OR PLAN:'\Eil (Selected) 

Chair: Well Over IOU Hisl;: Assessmt•nt Peer Review :\clcetings 

Since I 'ISh. and to the present. I have chaired well o1w 100 scicntilic peer rc1ic"' mcc:tings l(n 

ri.sk assessment documents. Documents haY<: coYcrcd a number or topics including risk 

nss(·~smcnl n1cthnds and a~scs~n1cnts includint! cancer and non-cancer toxicitY, These n1cctinus 

ha\'l' bc.;n spoHsor,·d by a number or organizaOtHlS through <:it her Toxicology'l:xcdkncc Jl•r • 

Risk i\sscssmcnt's ( rt:R.l) program ol'thc International Toxicity Estimates f(,r Risk (IT!:'R) 

database ( f(H· c.,mnpks. pkasc ,;ee \\\1 w.tcra.org.'pcc,rj. b;. U'A through its IRIS databas<: (sec 

\\1\\l.epa.goyjris). or b) group:; such as Vcr:;ar. These· rc1"il'\\S ha1c discussed well owr -100 

dll'tniL:als ur risk issues. 

Chair: Tox21: CmTcnt l'n~~t·css, Next Steps and Explorin~ the Concept of a New CNtter of 

Exccllcncc 

Society of Toxicology. Baltimore. 1'-·laryland. \-larch 12. 2017. 

Co-<·hair: Low-Dose :\on-Monotonic Responses 

Socict: oi'Toxicoltlgy. Baltimore. Maryland. \larch 1.{. 2017. 

Chair: EndoL•I'inc Disruption: RL•scarch, Arntl~·sis, Regulation, & Communication 

Society oi'Toxicolngy. i\cl\' Orleans. Louisiana. i\,1arch H. 2016. 

Chair: Dcrin~d No-EITt•ct l.t.>\'cls+ Big llata Toxicoln~tY ;\lccting 

Society nf Tuxit:olog;.. 'c" Orleans. Louisiana. \lan:h 13. 20 I 6. 

\lidwd I. llourson. Ph.ll .. !lAB 1'. h\IS. I·SRA 
89 


27172.084

:\lotlcnttor: Can/Should pt•cJ·-rnicwed puhliC<llions IH' used to formulate regulatory 

polic~'? 

Soeict: oi.Tn;;icolt>g). San Dicgt>. Calil<>rnia. \larch 23. 201~. 

Chair: Bt•yoml Sci(•JH't' and l)ceisions: From l'mhkm Formuhllion to Dose Responst• 

c\llianct: for Risl.. Assessment. Cincinnati. Ohio. l'vlay 9-1 L 20!5. 

Facilitator: Integration of Scientilk Evidence to Inform Ozone Effects on lluman llt•alth 

l"c:-;as Commission on 1-:nvironmcntal Quality. i\ustin. Texas. ;\pril X. 2015. 

Chair·: TTC Thn•shold Lt•nls & TTC Decision Tree 

I:FS:\/\VI !0 workshop on Threshold ofTo.~icological Concern CITC). llrusscls. Belgium. 

llcccmbcr 3-5. 20 1-l. 

Chair: Chemkal Assessment AdvisorY Committee for Ammonia 

l.' .S. Lm ironmt:ntal Protcction ;\gcncy ( 1-:l'i\). Washington. D.C. July l.f-1 (>. 201-f. 

Chnir: Beyond Scienct• ami Decisions: Fnnn l'rohlem Formulation tu Dose Response 

i\lliancc for Risk .-\ssessment. Austin. Texas. \lay 20-:.'2. 201-f. 

Chair: Ex put Panel HcYiew of Screening Levels for Exposure to Cht•micals Fmm the 

Janu:u!· 2014 Elk IUnr Spill 

\\'c•st Virginia Testing J\ssessment Pmje<:l. ( ·harlcston. \\'est Virginia. \larch 31. 20 !.f. 

Chair: Workshop to Assess the Modes of Action of Lung Tumor.~ in Mice From Exposun·s 

to StJTcne Ethylhcnzcne, :md Naphth:1lenc 

St' rC'nc lnl(•nnation & !{cS<:an:h Center. Cincinnati. Ohio. September 17. 20 1.1. 

Chllir-: Melding Exposure and Toxicology Science I the 21'1 Century·: :Vloving from !Iazard 

to a Hisl; Bast'tl Paradigm 

!'he Toxicology Forum. Aspen. Colorado. July 7-11. 2013. 

Co-chair: Ad\'ancing Hisk Assessment :\pfli'Oaclws •. .iullle 21st Ceutury 

rhe Toxicology Forum. Washington. DC. January 30-F..:h. 2. 2012. 

Happortt'ur: Wt'ight of EYidcncc Workshop, Session #I: From Rc\·icw to lnferenct• 

Ccnt<:r !'or Athancin!.! Risk i\sscssmC'nt Sckncc and PoliC\ (.'\Ri\SI'J. WashinQton. DC. 

Decem her .f. 2012. ' . ' 

Chair: Soil Exposure: What Ilm·c We Ll'nrned and !low Do We Improve l'rohlcm 

Formulations for· Risk Assessment 

I he lo:-;icology Forum. ;\spen. Cnlorado. July 10-l.f. 2011. 

Co-Chair·: lktennination of the Contribution of hulh·idual StJ·cssors in Cumulatin Risk 

Assessments 

St>cicty of Toxicology ,\nnual ~·keting. Salt Lake City. l 1tah. March 6-12. 2010. 

Chair: Fetal and Eari~·-Life l'cn:hloratc Exposures mul Outcmncs 

S~ llljWsium. Pcrchhlratc Exposures. !odin.: :vlodulntion of Effect. and Epidcmiologi<: 

.\sS<ll:iations: Implication;; l()r Risk t\ssessmcnt. An :\ncillary Pmgramofthc Annual iv!ccting 

of the Sncicty <•f Tn:\ieology. Scattlc. \Vashington. vlan.:h 2008. 

\lichad 1.. Dnurson. !'h.ll .. !Mil r. l·i\TS. FSR.-\ 
90 


27172.085

Clwir: J>erchlnrocth~·lenl' (PERC): Approaches To Evaluating (!uccrtainty In Health Risk 

Assessment 

I m:icolog1 Forum. \\'ashington D.C. January '0-Fchruar) I. 2!lll7. 

Chair: :Vlcch:mism/"'lodc Of Action Analvses 

Ris~ :\sscssmclll \kthodology Tcchnicall';mtmittcc. Weight orhidcncc \\'nrblwp. I lcalth 

and 1-:!1\·ironrncntal ScictK.:s Institute. llaltinwrc. i'vlaryland. Dcccmb.:r 7-8. 200(1. 

Session Planner and Chair: Issues In Tl'ichlt~rm•tll\·lcnc Risk Assessment 

\lidwcst States Risk :\sscssmcnt Symposium. lndian:ipolis. Indiana. i\ugust 2:>. 2006. 

Session Planner and Chair: l'ancl Discussion On Trichlorortlwkne ToxicitY 

\lid11cst States Risk Assessnll'nt Symposium. Indianapolis. lndim;a. August 25.' 200~. 

Chair: Scn•ening Ll'\'l'l Assessment Of Exposure Ami Characterization Of Risl' For 

llumans 

Risk ivlcthndol<>gics J·:xtcrnall'ccr Rc1 ic" !'and \lccting. l'hc• Soap and Detergent ;\ssm:iation. 

Washington. D.C .. January 1~. 200-l. 

Chair: A Rniew of tlw Reference Dose (Rm) and Refl'rcnee Concentration (RfC) 

Processes 

htcrnal Peer RCI'il'll rnr liS. El';\ lia Vcrsar. \\'ashingttll1, D.C .. June 19.2002. 

Session Planner ami Co-Chair: ;'1-lodcling of Population Variahilily 

Soci.:ty <>1"1 <>Xic-ology. ;-;ashville. T:\ .. Tucsdu). March I '1. 200:2. 

Co-Chaired l\letll\'1 Mcnury: Risk Assessment, l'olin and Research Needs 

Childn:n·s I kalth :;nd the l'n;·ironmcnt 2000. I 9'" Intcrncnional Neurotoxicolou,· Conkrcnce. 

l'olorado Springs. Colorado. September 26. 2000. '· 

Session l'lanncr and Co-Chair: Effcctin Risk Communication: A\'oiding the Pitfalls 

Continuinl! Education Ct1urse at the Socidv oi'Toxicolouv i\nnuall\lcctinu. Scattk. 

\\ ashingtt~n. \larch I. I 'NS. • -- -

Lead: l'ancl Discussion on Information Rcsnurces for Toxicology and Em·irnnmcntal 

I h>:tlth 

Socict;· oi' Toxicology. 1\C:\C. ( icorgc Washington University. Washington. DC. June I 8. !9%. 

Moderator·: \Vot·kshop on Toxil'ity Assessment 

:\I llarmunization oi'Stak 1Feckral :\ppn>achcs at the Em·irt>mnental Risk Symposium. Michigan 

Stat~ l 'nil ersit1. \Ia' 20-2!. I 996. 

Chair: Scssion on Risk Assessment 

( 'hromium Symposium. i'vlultiplc Sponsors. Arlington. Virginia. :\pril 23-24. !9<)(,_ 

Session Phumet· and Co-Chair: Risk Assessment of Essential Trace Elements (ETES) 

Society orT,,:.;ic·o!ogy Annual Meeting. Anaheim. Calili,rnia. !\·larch 13. I 'l9<>. 

Session Planner and Chair: Risk Chantcterization 

In: !\c\\ ·1 cchniqucs in Risk :\sscssmcnt. lntcmationall\usincss Comtnunication. Orlando. 

l'i<ll'ida. h:hruary 16. 199!1. 

Session Planner and Chair: EI'A 's Integrated Risk Information S~·stern: Future Directions 

In: '\c11 l'cchniqucs in Risk Assessment. International Business Communication. Orlandn. 

!·lorida. February 14. I 'l%. 
91 


27172.086

S<·ssion Planner· and Co-Chair: ltol~ ofTnxknlng_~ in Tomorrow's Risk Asscssnwnt 

l'r·acti<'<•s 

Spnnson:J b) the Society l<1r Risk ,\nal~sis and the International Congress oi'Toxicl11ogy. 

Sc·attk . .lui; 2-6. I <J<J:i. 

Session Planner :llld Chait·: Tl·ehniqucs for Quantif~·in~ I im·<·rhtinty in Risk Assessment 

Sc>cicty of Toxicology /\nnual1v1ccting. 1\larch ! 9. ! 995. 

Session l'lnnncr and Co-Chair: Stntistiraland Dose Response !\lndels in Risk Assessment 

Society of Toxicology Annual t>. kcting. t'-!arch I R. ! 995. 

i\1l·mher of th~ Planning Committee: Workshop on Benchmark Dose Mcthndolo~~· 

Sponsored h: the Fl'i\. the :\mcrican lndustrialllcalth Council and the International Lik 

Scicnccs lm;titutc. l·airl:ts. Virginia. S.cptcmhcr 28-JO. I99_;_ 

Session Planner and Co-Chair: Basics of Risk Assessment 

In: ( 'onfen:ncc on the Risk ,<\ssessmcnt Paradi!.!.m after Ten Y cars: Polic,· and Practice Then. 

~m1. and in til<.' Future. Sponsored by the \J.S.,i\rmy. :\ir Force. :--<a,·: ;\nd 1:1':\. Da: ton. Ohio. 

,\pril 5. I 993. 

Sl'ssinn l'lanncr and Co-Chair: Basic Risk Assessment: Current Denlopmcnts 

Cnntinuine hlucation Cour,;c at the Socict\ ofToxkoloe\ ,\nnual \1ccting. ~c'\1 Orkans. 

Lnuisiana::V·!an:h 1·+. I'JlJ~. · '· ' 

\ h·mhcr of the l'lannin~ Committe<·: Risk Asscssnwnt of Essential Elements 

Sponsored hy tr.S .. \TSDR. El':\ and the Intcrnationall.iti.: Sci<:nccs lmtituh.'. I krndon. 

\'irginia. tvhirch I O-I2. I '192. 

Session l'lanner· and Cn-ChaiJ·: Improvements in Quantilath·c Noncanccr Risk .-\sscs.~ml'nt 

Society oflosicnlog:. Sc·atth:. Washington. Fdmmry 27. 1992. 

Session l'l:mner and Co-Chair·: :\curntoxicity ltisk AsSl'ssnll'nt: State of the Art 

Society ,,r ro:-:icoh>gy. Dallas. Texas. ivlan:h I·. 1991. 

S<·ssion Planner and Co-Chair: lmpr·ovcmcnts in Quantitati\'c Noncanccr Risk Asscssm<•nt 

So..:id: ofTo~icolc>g). San Franc-isco. Caiitim1ia. Fc·bruary ?.7. 19X5. 

SERVICE: APPOINTMENTS OR ELECTIONS (Sl'l<·ctrd) 

?.017 to ... 

?.OI 1-17 

200'J to ... 

?.007 (\), . 

?.007 to ... 

..\ssociatc Editor 

l'u:\icologkal :-;L'it.:nccs 

Member· 

Science i\d1isory Roard of the\ i.S. l·:nvironmcntall'rotcctinn Agcnc·y tFP,\) 

1·\·llow 

Socict} lin· Ri'k :\nalysis 

Advisor 

i\li·ican Society of Toxicological Sciences 

Fellow 

\!idmcll.. ll<>ursoll. Ph.D .. !lAB t. FA IS. i·SIU 27 
92 


27172.087

•\cadcmy of Toxicnl<lgical Sciences 

I'J'J<J to .. Memhcr· and Vice Chair· (2003) 

I kalth ,\,h·isorv lloard. '\SF International 

1'!9.:' to ... Member· 

hlitnrial [l,,ard of the Journal .. Rcgulator: Tnxiwlogy and Pharmacolugy .. 

1994to. ;\I em her 

Editorial lloard oft he Journal "!Iuman and 1:xpcrimcntal Tnxicology" 

20J(,to ~017 ScCJ·ctan 

Board or' Directors. Toxicolog: l'nrum 

20 l.f to 2017 Vice President Elect, Vice l'rcsidcnt. !'resident 

Socic:ty of Toxicology's Special!: Section 1(11· Regulator: and SaJCt) h·alumion 

2012 tn 2017 l'rcsidcnt and Member 

Board of Directors. Toxicology hlucation FounclatiL'Il 

2012to2017 Ml'mhcr 

2015 

2011-2014 

2010-2015 

2010 

Science i\Lh isory Council. North American Flame Retardant 1\ssociation 

Member 

Joint "k..:ting of the: Food ami Agriculture Organization of the l !nitccl '\at ions 

( !·,\())I' and of 1:xperts on Pesticide Residues in Food ami the l'n\·iromncnt and 

thc World I kalth Organitati<ll1 (WIIO) Core Assessment Clroup on Pesticide 

l~csiducs (.1\!PR) 

Discussant 

Increasing the manganese rd~rcnct· \·aluc despite the gnl\\ ing cn\·ir<lnmcntal 

and hL·ttlth concerns. International Manganese Institute. l !niversity of Ottawa. 

Cktoher 14. 2015 

Member 

Joint "lcctinu of the Food and ;\uricultur.: Oruani7ationni'thc l !nited ;\lations 

(h\0) Pancl~or Experts on Pesti;_:ide Residues in Fo\KI and the Fm ironment and 

the World llcalth Organization tWIIO) Core Assessment Grour on P..:sticidc 

Residues (.li\WR l 

;\·I em her 

World I kalth Organi;ation & Eurorean Food Sakty Commission F:-:pL.-rt Panel. 

Worblwp on Re\'ic\\ o!'thc Threshold oi'Toxicologkal Conccrn (lTC) 

;\pproach. llrussds. lklgiurn. lkcc·mbcr 2-4. 20H. 

;\I em her, Co-Chair, Chair 

ivlcmbcrship Committee of the Society oi'T<l:-:icology 

Chair 

i\udit Committee o!'thc Sodd) f(1r Risk J\nalysis 

Faculty 

\clichael I. I hnll·,,m, Ph.ll .. IJ/\!l r. F.YI S. FSRA 
93 


27172.088

200')-2011 

2008-201-1 

200S 

20IIX 

::om 

R~sourcc person ltl the Risk t\sscssmcnt Summ~r School ( RASS) in Calabar. 

Nigeria. sponsored by the lntcrnntionall 'nion ofloxicolog\. \ola) 26 to~() 

\'icc President Elect, Vice !'resident, !'resident 

~ocid; uf !"oxicnlngy's Specialt:- Section nn \-fixture:-: 

'\I em her· and l'r·csid<•nt 

Council of \lt. /ion Lutheran Church 

l'ar·ticipant, Essential !\lctals Workshop 

Institute of l'<lpulation llcalth, llniH?rsit) of Ott<!\\ a 

.'vlcmhcr· 

(orccn Chcmistr\ lnitiatiw Science ;\d,·isllrY Panel. Calili1rnia l·:m irllnmcntal 

J>rotcCiion J\~c1iey. Department <>i"To\ic Stih\tanccs Contr\ll. San Francisco. C.-\ 

Lecturer 

Shanghai \.lunicipal Center l(w Disease Control and Pn:wntinn (Shanghai CDC). 

National Colllinuinl! l1.dueation Traininl! Workshnp on ( 'hemical Risk Assessment 

and Its Dc,·clnpmcl;l. Shanghai. P.R. (hina 

2006 to 2007 \!ember 

~006 

2005 

200-l 

The H "( lS and DoD Sustainability \\'orkt!nHlp. I lcp:lrlmcnt of llcknsc. 

\\"::shington. D.C. 

Panelist 

.!Pint meeting <lfthe dental products panel of the medical devices ad,isory 

commillcc ol" the CDR II and the peripheral and central ncn·ous systc·m drugs 

ad,·isory· commitlec or the CIWR. h1ml and Dru~ 1\dministration. September (1- 7 

Happnrtcur 

\\'orksllllp on Poisons Centres and the lise of !Iuman Data in Consumer l'roJuet Risk 

.\sscssmcnt. Work llcalth ( lrg:mi~ation ( \\'110 ). lkrlin. ( ocrmany, i'•lay 'J-1 0. 200) 

l':rndisl 

I cdmieal \IOrkshop on human milk sun·cillancc anJ biomonitoring lin· 

cn1 irnnmcntal chemicals in the l 'nitcd States. i'vlilton llcrshc' :Vkdical Center. 

Penn State. Penns' hania. September 2-1 [(1 26 · 

cOin ln 200(1 :Hem her and Chair 

\\'orld Wide Web !\ddsnry Committee. Society oi"To~icolog) 

200~ Panl'l \·!ember 

\lid-(",cJe Peer Rc,·ic\\ l(n NIILERL"s ~eurotoxicolm.>\ lli,·ision.l .S. LP,\. 

RTI'. :\.c ,. 

20()! to 2005 Sccretan 

Society l";>r Risk :\nalysis. 

2001 l'ancl '\!ember· 

Peer Rc< icw for i'\111:1-:Rl ."s Neurntoxicolog:· Dh ision. l '.S. U'.\. RTI'. NC 

200ilto 200 I Tcmpon11~· Advisor· 

\lithaell.. D<lur,on. l'h.ll. Jl;\llT. FATS. F<;RA 
94 


27172.089

\\'orld I Icalth OrL!ani;~ation l\1r C'<HNtltation on linc.:rtaint' and Variabilitv: 

ll(IVV. Berlin Ci~rman~. 9-1 I May · · 

2000 to 200 I Advisor and Rapportcm· 

Food Sali:ty in "un>pc: Risk assessment <>f chcmicals inl<1od and diet. I LSI: 

Barcdona. Spain 

\tcmber 

l'<mel li1r the harrnoninnion or cancer and non-cancer risk assessment. Sockt:· or 

rm,icolog:. i'<<l\L'Il1bCr I-.\ 

I 1

!99 to 2002 Member 

Ch-c·rsight (!roup li•r the 1-:Pi\ Cot1pcratiYc :\grccmcnt. George Washington 

I :niH:rsit;. 

I'!'!'! to 2002 Vice President Elect, Vice Pn•sidcnt, I' resident and Councilor 

Sockt\ ofTo~icology's Spcc:ialt~ Section on Risk .'\sscssmcnt 

i9<JX to 200-'1 Exccutin Director and Treasurer 

Com.:ordia Lutheran Church. Cincinnati. Ohio 

19W, 10 1998 \temhcr 

I 'J'J5 

I··D1\ Scic•ncc Board Suhc(lmlllittcc on 'J'o,icnlogy 

Co-Guest Editor· 

Fl'.-\ l inccrtainty Factor Workshop. I Iuman and Fcological Risk .-\ss.:ssmcnt. 

I(:" \:512-(>62 

l 'Jii5 tn I 999 i\lcmhcr, Trcasur·cr-, Vice !'resident, and Pn•sidcnt ( 1998) 

lloard o!' Directors o!' I he !\mcrican Board o!'To.,icology 

I <J95 to I 9% Prcsi<ll-nt (fir·st cl('ctcd) 

Dose-Response Specialty Group. Snd.:ty fpr Ri.sk Anal;sis 

I <JlJ5 to 2006 Scoutmaster, Assistant Scoutmaster 

I t'<lop rn of Concordia l.ulhcran Church. Cincinnati. Ohio 

I 99-l tn 2007 .\!ember· 

hlitorial Board of the Journal I Iuman and Fcnlngical Risk ,\sscssmcnt 

I 99-+ l<l I ()95 Director. J>ropcrty Board 

Concordia Lutheran Church. Cincinnati. Ohio 

I 994 to I 995 Cuhmaster 

Pack D3 ,,f Concordia Lutheran Church. Cincinnati. Ohio 

l'llJ l H> I 994 l'r·esident-Eicct, Pr·esident and Councilor 

1993 

199~ 

The Ohio Valky ( 'haptcr o!' the Society of Risk /\twlysis 

.\lcmher 

( 'onnnillcc on l.uthcran i\li";ion rvtinistry Strategy liH· Greater ( 'incinnati 

Expert Witness 

OSJ lA 1{11' lnt(mnal Public I leming on the Proposed Ruk on Occupational 

F\posurc lo \ilycoll'thcrs. \\'ashingtnn. D.C .. July :'.I 

\lic'hacll.. llntll''<liL l'h.IJ .. I Mill. 1:;\ I'S. FSI(:\ 30 
95 


27172.090

199) Temporary Advisor and .Joint Happorll'Ur 

World I kalth Organization i(>r Consultation on Guiding Princ:ipks and 

\.kthodnlogy I(Jr QuantitatiYc Risk Assessment in Setting Exposures Limits: IlL 

( icnc' a. S\\ itzc:rland. June 14-1 S 

Faculh 

As pari or an LP ;\-spnnsorcd dckg:nion to teach a course on Em ironmcntal 

Management-Risk :\sscssmcnt J'raining. l.ndz. l'nland. 1Vlan:h 29-:\pril 2 

Temporm}· Advisor 

\\'orld I kalth Organization l(w Consultation on (iuiding l'rincipks and 

\kthodolog~ I(Jr Quantitati\<: Risk Assessment in Selling Fxpnsures l.imils: II. 

l.angc,n. ( icnnany. January I 9-22 

T~mpm·m}· Advisor :111d Co-\'in• Chair 

World llcalth < lrganization !(Jr ( ·onsullation on Guiding Principles and 

i\·lethodnlogy li>r QuantitatiYe Risk Assessment in Setting Fxposurcs Limits: I. 

( il.'llL'\ a. SwivcrlamL January 14-17 

I()<)() to l'l9} Vice President and President 

;\c:adcm) of K<:llc:ring Fcllo\\s. I 'ni,wo-ity of Cincinnati. ( 'nl!cgc of \kdicin~ 

l'll\8 to 1992 Coundlm· 

Til<: Ohio Valky Chapter of the Sodct~· of loxicoi<>gy 

l <)88 to 19l)O Vice !'resident (intuim), President (first elcl'led) and Councilor 

Society of Toxicology's Specialty Section on Risk ,\sscssmcnt 

19ll7 to l'l'l2 Chail· 

FP:\ l{isk Ass<:ssmc:nt Forum's technical pand to dc,·dop Ri,;k Assessment 

Guiddincs !()I· Non-Cancer llcalth Efl\:cts 

llJX6 to I 99.) Trcasur·cr, Vice !'resident and !'resident 

I ,uth<:ran ( 'hurch of th-: Cross. Cincinnati. Ohio 

19S(, to 1994 Clwir and Co-Chair 

Rcl(:rcncT Dose (Rfl)) Work Grnup of the EPA (\\ith a l year break in sen icc) 

1986 hi 1995 Charter :\I em her 

Risk Assessment Forum of thc U':\ 

A WAHDS (Sdcl'tccl) 

}0 17 Outstanding Regula lot}· and Safct~· Evaluation l'npc1·. ( li\ en J(w the 

out~tanding published pap<:r in regulatory and safety evaluation during ~016. 

Regulator) and Safety l'saluation Specialty Section (RSl·:SS). Society of 

roxic,,log). ;\\\ard was based on a gmup cfl(,rl. 

201.i Risk Communication Award. KidsChcrnicaiSal~ty.org was honored with the 

,·\lliancc !(>r ( 'hcmic;ll Sal~ty. The risk communication award rccogni;.cs a 

~lit had 1.. llour;o11. Ph.D .. IJAB I. F,\ IS. FSRA ) I 
96 


27172.091

wmpan~. organintion or indiYidual who has shtmn outstanding leadership in 

communicating about chemical risb . .-\ 11ard was based on a group cl'liJrt. 

20 1.' Best Charity Award. Toxic Chc•mical Sakty a \larded l(lr rccugnition ;1s one of 

the 'Ill'S!" charities in America. l'n:sented upon rigorous independent rc,·ic\1 l\1r 

being able to eertil). document and Lkmonstrate on an annual basis that met the 

highest standards ni' public accountability. program ci'll:eti1·cness. and cost 

L'lkcti1·cncss. 

200'1 International AchkHml•nt Award. In recognition ol'his outstanding 

contributions nationally and international!~ to the a<ilanccmcnt of regulatory 

science. policy. and methodologies in risk assessment and risk management and 

li1r his distinguished ami ercati1-c participation in regulator~ organi~:ations and in 

Lh:cisi<lllS of' ultimate public he<lltb signiticanc.: worlth,itk. International Soeiet0 

,,f Regulatory Toxicolog: and l'harrnacol<>gy. 

200S 

200X 

2007 

2002 

2000 

Outstanding Hisl< Assessment Paper. Cii1en I(Jr the outstanding published paper 

in 2007 tknwnslrating an application of risk <lSscssmcnL Risk Assessment 

Specialty Section. Socict~ ofToxicolng~. :\11ard was base·d on a group eflllrl. 

The lndcpcmlcnt Chadtics Seal or Execllcnec. Gi,·en to the members of 

Independent Charities of :\mcrica ami I .ocallndcpcndcnt Charities of :\tncrica 

that h;l\ c. upon rigorous independent review. been able Ill ccrti fy. document. and 

<knwnstrate on an annual basis that they meet the highest standards of public 

acT<>untability. program ct'li..·ctiveness. and cnst t:lfccti' eness. These· standards 

include those required by the· liS (i<li'Cfnment I(Jr inclusion in the Combined 

h.:dcral Campaign. probably the mnsl cxdusi1·e fund drin~ in the 11orlcl. Of the 

I .000.000 charities operatin!! in the 1 lnited States toda). it is e'~timatcd that tl:11~r 

than 50.000. or 5 percent. meet or exceed these standards. and. ni' tho,;c. 1\:wer 

than 2.000 ha1e b..:cn a11ankd this Seal. ,\liard 11as based on a gwup cmm. 

Scn·ic(~ to the Voluntary Children's Chemical Enlluation Program 

(\'C'CEI'). (iin~n I(H· sL"r,·ic.: as chair and participant on external rcl'iCII panels. 

To.xicology b;cellenc..: Jill' Risk Assessment. Cincinnati. Ohio. 

Arnold .1. Lehman Award. An ;mardin n:cognitinn nl' major contributions to 

risk asse~smcnt and the regulation ol\:hemical agents. in(luding pharmaceuticals. 

Society ofToxkology. 

Envimnnu•ntal Stcwanlshir Award. An award i,:sucd in gratitude for sen·ing 

on the' ex ;\sSL'SSllll'llt of' Toxicity Team as a toxieologi,;t in the dL'\'dopmcnt of 

toxicill' hlctors and screening k\'(~ls. West Virginia. Dcpartmcnl of 

I ·:n1 ironmental l'rotccti<>n. i\11ard was based on a group ei'I(H·t. 

Key Risk Awm·d. Em·ironmental Studies Topic. Links2Go. T/Ji.-l's International 

Toxieit: Estimates l(•r Risk (ITI-.'Rl database ll'on this award hy being 7' 11 most 

;lccesscd en,·ironmcntalwcb site in the \\orld. :\11arJ was based on a group 

cf'l(,rt. 

32 
97 


27172.092

I<J'lX 

1995 

199-t 

1992 

1992 

]91)2 

jl)f)j 

1990 

1987 

1'!86 

l<Jl.i-l 

19~(1 

Outstanding l~isk Asst•ssment l'aper. Ciivcn l[>r the outstanding puhli~hed paper 

in risJ.. assessment during I 9'17. Risk Assessment Specialty S.:ction. Socict,· of 

Toxicology. A '"'ml was based on a group effort. 

In Appreciation. An all'ard lt>r outstanding scn·icc and scientific contribution to 

the Em ironmcntal Prnt<.Ttion Agency and to l 'nit.:d States ( io,·crnmcnt. 

Special Achicn-menl . . •\n a" anll[>r noteworthy contribution as a member nr 

the Risk Characterization Team towards an EPA-wick \\orkshop on risk 

charactcrizatitln. 

Bronze Medal. An a\\ard l\1r outstandinl! ,;en·icc in the review oiTP:\'s 50:i 

Sludge Regulations. :\\\ani \\as based on-a group el'I\H'l. 

OHEA l't·er Award for Scientific Aehicnmcnt. i\11 annual peer :m·anl for 

>cicntilic achicn~mc~nt in EP :\'s O!'ticc of llcal!h and lcn,irnnmcntal Assessment 

Rfll/RfC Work Group Appreciation Award. F(W sustained superior 

kackrship ofanJ scientific contributions to l'P:\'s Rcli:rcncc Dosc'Rcli:rcncc 

Concentration \Vtwk On>up. 

Bron:r.c Medal. An award for outstanding scn'iCc in the dcn:lopmcnt ()f EP:\ 's 

Integrated Risk lnformatinn System (IRIS). Award \\as based on a group cfl(lrl. 

Special Achievement. ;\n El' A award l(>r ensuring OR D's successful 

im n!vcmcnt in rc·gulatof\ support issucs with U'Ns Office of Pesticides and 

('pxic Substances. 

Special Achit•vemcnt. i\n EP;\ award l(lr resolution of g<:neric issues 

associated "ith the minimum data base needed to <:stirnatc Rcli:rcncc Doses 

!RIDs). 

Special Achievement. i\n award lbr further dc1·clornwnt of the EPXs --

Integrated Risk lnll>nnation System {IRIS). 

Bronze 1\Jcdal. An EPA ;mard "!i1r outstanding sen in: in the organization and 

rcvicH <>fRisk Ref.:rencc Doses (i\cccptahlc D7lily Intakes) and tile science from 

which they arc dcriwd." ;\ll';ml was based nn a group ef!i>rt. 

Trihutc of Appn·ciation. :\n EPA award l(lr the "lk1elopmcnt of Risk 

:\sscssmcnt Uuidclin.cs." 

Coach of theY ca•· (soct·cr). Greater Cincinnati I .cague (Catholic Boys J Iigh 

S.;hnol) 

Bronze i\-Jedal. An EPI\ H\lard recognizing "Outstanding dedication. completion 

,,f tasks and ct>ntributions to em ironmental pmt<:ction in th.; ""' dopmcnt or 

Water ()uality Criteria." ,\ward was based on a group enl>rt. 

AFFILIATIONS 

:..ticliael t.. ll<>UN\11, l'h.D .. llAI\T. FATS, FSRA 
98 


27172.093

I am :1 m~mh~r of the :\mc:rican ;\sS\lciatinn 1\ll' thc ;\d\cancc'ment uf Science ( :\A;\S). the 

Society I(H· Ri:<k :\nalysis (SRA). and the Socicty of Toxicology (SOT). I am a Diplomate nfthc 

cc\mcrican !\(lard of Toxicology (October 1 Q!\5) and was rcccrtilied in I <Jl!O. 19fJ5. 2000. 2005. 

20 I 0. and 2015. I am an elected Fellow of tile 1\cmlcnw of rmicolo!!ical Scicnc.:s and the 

Society ltw Risk :\naly sis. · c 

REFEREN<"ES 

Rclercnccs \\ill he rc<Klily supplied upon request. 

~1irh;wl L llotnwn. Ph.D .. DAilT. FATS. FSHA .>·1 

27172.094

Summary of billed hours of Toxtco!ogy Excellence for Risk Assessment (TERA) for the years 1995 to 2015. and donate

~-Year 

- Non Profit o/~of Billed~-ProflC 15/o 6f8illedp5onated-t!me--··a;o 6H3illed I 

1995 917 67% 457 33% 166 12% 

1996 1.248 38% 2.073 62% 701 21% 

1997 2.173 53% 1.949 47% 769 19% 

1998 4.841 61% 3,106 39% 1.133 14% 

1999 5.631 66% 2,925 34% 879 10% 

2000 4,949 58% 3.583 42% 1,501 18% 

2001 5.197 47% 5.964 53%, 1,391 12% 

2002 11,407 72% 4.527 28% 2.104 13% 

2003 10.534 79% 2,870 21% 2.335 17% 

2004 12.238 82% 2.629 18% 2,109 14% 

2005 11.477 82% 2.538 18% 1.962 14% 

2006 9.932 73% 3,741 27% 1,807 13% 

2007 10,727 72% 4.225 28% 2.112 14% 

2008 9,588 67% 4,812 33% 1,578 11% 

2009 10,806 69% 4.966 31% 1,767 11% 

2010 10,548 66% 5.434 34% 1.849 12% 

2011 9,569 67% 4.713 33%> 1,650 12% 

2012 9.250 60% 6.166 40% 1.126 9'% 

2013 11 '183 63% 6.585 37% 1.577 9% 

2014 8,071 57% 6.006 43% 1,541 11% 

2015 9,669 68% 4,550 32% 1.403 10% 

• These hours do not mclude marketing, general science or administrative times 

27172.095

Sponsor 

Acrylonitrile Group 

AECOM 

Albermarle 

American Chemrstry Council 

Amli!rican Chemrstry Councrl 

Amencan Chemrstry Counctl 

Amencan Chemrstry Councrl 

f>.mencan Chemistry Councrl 

Amencan Chemrstry Councrl 

Amencan Chemistry Council 

Amerrcan Chem1stry Council 

Amerrcan Chem1stry Council 

Amerrcan Chemistry Counc1l 

Amencan Chemistry Council 

Amencan Chemrstry Councrl 

Amencan Chemrstry Council 

Amencan Chem!stry Council 

Amencan Chem1stry Council 

Amencan Chernrstry Council 

Amencan Clean1ng Institute 

t>.mencan Cleanrng lnstrtute 

American Petroleum Institute 

Amencan Petroleum fnstttute 

Amgen Reagents 

Aquilent 

Aqwlent 

AVV\NA AmerJcan \/Vater Works Assocmtton 

Battelle Memonallnsti!Ute 

Battelle Me-mortal lnst1tute 

Battelle ~J~emonal Institute 

Project Description 

Proposal to rev1ew acrylonl!nle IRIS external draft and prepare public comments for 

TERA organrzed an rnclependent expert panel to rev1ew a draft work plan for a 

Revrew EPA design for enwonment text on flame retardants 

Th1s proJect IS an enhancement of the ARA Dose Response Framework that was 

For Beyond Sc1ence & Decis1ons. contmuat1on of case study 17. Low dose lrnear 

Develop a k1ds nsk webpage. rn part 

Build on prevrous work to develop RfD. mcludrng crrt•cal evaluation of 1ssues, 

TERA w1ll revrew DINP toxrc•ty data and provrde expert oprnion on relevance of chrome 

Conduct mode of act1on assessment for liver tumors 1n rnrce exposed to diethanolarnrne 

Assessment Sere nee and Po trey's (ARASP) Werght oi Evidence Workshop 

Revrewed stUdies to determ1ne crrt1cal effect{S). prepared manuscrrpt submrtted, 

Analyze the current display of the uncertarnty and vanabilrty m the IRIS sum manes 

Co-wrrtrng a paper on Bayes1an approach to developrng RIDs 

ITER (lnternatronal Toxrc1ty Es\rrnates for R•sk) Peer Revrew Program for TCDD 

Presentatron of recent ecolog•cal TBBPA data at SETAC m 2014 

Prov1de asststance m developing and presentmg a contlnu1ng educatiOn course at AlHce Gi~ letter funding the mutagenrc mode of actron adverse outcome case study 

Conduct BMD analySts of key stud•es and revrew data for other studieS worthy of 

Revrse rat PBPK model of propyl senes compounds. prepare report and poster. present 

Develop proposal for conductmg safety assessment case stud!es for selected deanmg 

Organ1ze workshop on sc•ent1f1c rssues regardrng asU1ma and cleaning products 

Prepare a rnanuscnpt for submission to a peer~reviewed JOurnal that describes the 

The proposed work mcludes (1) further developrng !i1e draft framework, (2) expandmg 

Deve!opmg nsk values (permrssrble da1ly exposures PDEs) to calculate tox•co!ogy-based 

lrm•ts for drug substances and/or reagents des•gnated by the sponsor A POE 1s the 

dose that would not result :nan appreciable effect to human health from relevant drug 

substance routes of admmistrat1on The POE 1s denved by analyzrng all potentral toxic 

effects such as acute chronJC reproductJVe, and carcinogenicJty and ctwosmg the most 

Orgamze and conduct subject matter expert workshop on term and defJnrt•ons of toxic 

Develop content for adc1tronal cr1em•cals 111 CHEMM 

Bnef assessment of the-- val!dtty of conduswns some commenters have attnbuted to the 

ORNL Hea!th AdvJsory GUJdance Respond to EPA commen:s on rev1srons to draft Scop~r1g assessment of vmyi acetate PBPK models for posstble use in US EPA 1RJS 

Scoptng assessment of PBP!< mcdels for possible use Hi US EPA !R!S assessment of 

Projec

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27172.096

Battelle Memonallns!!tute Battelle Memorral lnstr\ute 

Battelle Memonal Institute 

Bowles and Verna LLP 

Bnt1sh Society of Tox1cology 

Cal1fcrma Chamber of Commerce 

Card no Chemnsk 

CEFIC 

Charles A. Pittmger, LLC Chevron 

Chevron Phillips Chemrcal LP 

Chevron Phillips Chem1caiLP 

City of Cmcinnati 

Combined Federal Campa1gn 

Coca Cola 

Concurrent TechnologieS Corporatron 

Corona ErMronmental Consultmg LLC 

Dow AgroSc1ences 

Dovt Chem1cal 

Dow Chem1cal Dow Chemrcal Dow Cornmg 

Dow Cormng 

Dr:nker, Brddle & Reath LLP 

Eastern Research Group 

Electnc Power Research !nstttute 

Eli Lilly 

EnRrsks 

EnSIGHT ERr,;, Alaska Inc Ethyleneamtn-es Product Stewardsh1p Group 

ExxonMob!l 8JOmedJcal Sc1tmces, Inc 

Genentech Georg1a Pacrfrc 

Develop brodrfacoum model based on warfann model develop bromadrolone modelrf 

PBPK modelmg support for US EPA IRIS ass.esesment of PCBs 

"Qwck Response Statistical Report" EPA Contract No EP-C-09-006. QA of Htssmk et 

Contammated s1te necessrtates rev1ew and possible court testtmony on the plamt1ffs' srde 

regardmg cornpanson of levels of contamrnant exposure and health benchmarks TCE 

Attend the BSOT annual meetmg and make a presentation 

Rev1ew the CaiEPA Env Health Screenrng Tool and provide comments at a "meetmg of 

Prov1de a peer rev1ew on evaluatron of the we1ght of evtdence for endocnne drsruptron 

Investigate mode of action for ethylene oxtde-mduced lung tumors m male m1ce ProJect 

Draft ecological manuscripts for TBBPA 

An emergency response course for the EHS team, and perhaps rndivrduals from other 

Preparation of a Test Plan document, With robust sumrnanes, for chem1ca1s as rdentlfied 

2-day Emergency Medrcal Response tramrng course offered to Chevron 

Evaluate the health nsks associated with outdoor wood ftred botlers 

Develop a ktds rrsk web page, in part 

Develop a benchmark dose (BMD) for 5-HMF 

Provide semar-!evel peer rev1ew and comment on several tnd!VIdual susbtance report 

One day meetmg ;n West Vlfgmia to review available tox data and scrent;frc support for 

Develop a rl'lanuscnpt based on the prev!ously developed rssue paper w1th a cntrcal Prepare and ass 1st 1n preparat1on of manuscnpts from the nuclear recepwr \Vorkshop 

Chatr sess1on on so11 exposure at the July 2011 Tox Forum meetmg 

BMD course {related to Boot Camp) and DR 1 and 2 

Rev!e\v and rev1se 1ndustrial hyg1ene gu1des and occupatwna! exposure !im1ts {OELS) 

Application of uncertainty factor for the development of the IHG SubmiSSIOn of literature 

ldent1fy, gather, rev1ew and assemble available data on chemicals as defmed HI the 

ELSIE document Safety Database Search and Comp1la!ron Pmtocol Rev1ew EPA's text entitled. Application of Quantitative Data to Develop Data-Denved 

Case study rev1ev1 for \Norkshop 9 Adverse outcome path\·iay for a:-scntc 

Developrr,ent of OEL documents for pharmaceutical compounds 

Develop course tram1ng package, descnptwns and outlmes of atl courses and reviev: Determ1ne cancer slope factors for DINP us1ng Caltforn1a propost!Jon 65 I ogre and EPA 

Alaska DEC has tasked TERA wrth conducting an independent. expert peer revrew of the 

BMD rrlOae!lng support for ammoethy1ethanolarnme, evaluate relevance of endp01nts and 

Cntlca! re\new of ava!lable mforrnatmn on decalrn (decahycronaphtha!ene) to conf1rm 1f 

f\ss;st m developmg nsk assessment procedures 

Met v;ith sponsor to d1scuss opt1ons for IRIS remver:t1on 

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27172.097

GMA 

Gradrent 

Gradrent 

Halogenated Solvents Industry Alimnce 

Hamp. Mathews & As socrates. Inc 

HAP Task Force 

Health Canada 

Health Canada 

Hearth Canada 

Health Canada 

Health Canada 

Health Canada 

Health Canada 

Health Canada 

Health Canada 

Health Canada 

Health Canada 

Health Canada 

Health Canada 

Health Canada 

Health Canada 

Health Canada 

Health Canada 

Health Canada 

Health Canada 

Health Canada 

Health Canada 

Health Canada 

Health Canada 

Health Canada 

Health Canada 

Health Canada 

Heallh Canaaa 

Health Canada 

Health Canada 

Development of a perrodrc newsletter 

ITERate (lnternatronal Toxic1ty Estrmates for Rrsk) Peer Revrew Program Manganese 

Comment on and contnbute to manuscnpt on rssues and assumptrons behrnd arguments 

Provrde comments on EPA IRIS assessment for TCE to EPA's Scientrfic Advrsory Board 

Procure and translate Japanese studres on 1 .4-dioxane: develop analysts and publrsh a 

Route-to-route extrapolation of NOAELs and LOAELs from existrng and new stud res 

Letter revrew of phthlataes 

?eer revrew of nsk assessment documents on PFOS and PFOA wrth emphasis on dose 

Letter peer consultatron on flame retardant dechlorane plus. 

Revrew a 4-5 page specral rssue paper on boron dealing wrth ?8PK, BE and uncertamty 

Letter Consultatron on 3 flame retardants 

Assessment AEEA and Ethyl 

Co CAM 5. Three assessment peer revrews 

Revtew of petro!evm substances 

TERA organrzed and conducted an rndependent peer consultation of the draft screenrng 

Revrew documents provrded by HC draft Screening Assessment reports and outlines 

Coordrnate and manage an Independent peer consultatron of the draft screenrng level 

Develop a gurdance document for usrng bromon:torrng studies to estimate exposures for 

Posrtron paper and rnternal Health Canada peer consultatiOnS on rrsk assessment for 

Custom 3-day Boot Camp course 

Peer revtev.t of Batch 12 substances N,N-d!pheny! ~guanJdH1e, carbon black cnstoba!1te, 

Letter peer consultatron on flame retardants trrcresyl phosphate (TCP) 

Letter peer consultatron on 2 flame retardants. bis(2-ethylhexyl) 

TERA wrll select a rnrnrmum of 5 Canadran Publrc Health Surnmanes, based on 

TERA organ'rzed and conducted a letter peer consultatron on two draft gurdance 

Assessment of ~Jon-Cancer Effects due to Short-Term Exposure and Short-Duratron 

Update and complete the human healt!1 screenrng rrsk assessment report for acetone 

11 i prepare "toolbox" of nsk assessment methods, 12) framework and drscussron of 

Organrze and conduct rndependent screntrfrc peer consultatJOn on two draft Health 

Organrze and conduct an rndependent screntrfrc peer consultatron on the draft Health 

Coordrnate and manage an Independent external screntrlrc and technrcal peer revrew of 

Rev!ew of screerung assessrr.ent for tr~closan Rev1ew exposure seen a nos for azo dyes 

Conduct peer consultatwn of the revtsed hydrogen su!f!de assessment document TERA 

Peer consu!tatton of the rev• sed Stare of the Sc1ence repcrt on 1 1-b!phenyl 

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27172.098

Health Canada 

Health Canada 

Health Canada 

Health Canada 

Health Canada 

Health Canada 

Health Canada 

Health Canada Health Canada Health Canada 

ICF Incorporated. LLC ICL-IP Amenca Inc 

ILSI North Amenca 

Institute of Environmental Science & Research Lim•ted 

Institute of Environmental Science & Research L!m•ted 

lnst•tute of Environmental Sc1ence & Research L1m1ted 

Institute of Environmental Sc1ence & Research Lm11ted Institute of Enwonmental Sc1ence & Research Lim;ted 

Institute of EnV!fonmental Science & Research limited 

JT lnternatwnal S A 

LtfeLme Group 

Lifeline Group 

LifeLine Group Lockheed Mart1n Longenecker & Associates 

McKenna Long and Aldridge 

Merck & Co 

Merck & Co 

Methanol Institute 

Morrison & Foerster 

Multiple sponsors 

Multiple sponsors 

Nease CorporatJon 

Neptune 

Ne,•; Zealand M1n1stry of Health 

Orgamze and conduct letter peer consultations on petroleum stream products 

Letter peer consultatiOn on 4 azobenz1d111e assessn1ents 

Organ•ze and conduct mdependent sc;enlifiC op1mon on the Health Canada documents 

Organize and conduct letter rev1ews on Petroleum Stream Products 

Organ•ze and conduct a second letter peer consultation on petroleum stream products 

Organize and conduct mdependent SC1ent1f1C peer consultation on the Health Canada 

Orgamze and conduct independent scienlif1c peer consultation on the Health Canada 

TERA will rev1ew rat-human dos1metnc models and evaluate for d>esel exhaust exposure 

Part1c1pate 1n 2-day workshop on current state-of-knowledge 1n the health nsk 

Quantitative Uncertainty and Vanab!l1ty Analys.s of Perlluorinated Chem1cals (PFCs) 

The goal of this proJect IS to finailze the content for about 50 potential mass casualty 

Case study rev1ew for Workshop 9 flame retardant framework- for addressing nsk and 

Dose-response evaluation of relationship between Trans-fat Intake and LDL-choiesterol 

Rev1ew of f'Z nsk methods document 

Carry out a rev1ew of the Hobsonvtlle Health R1sk Assessment undertaken by Golders 

Wntten peer review for health assessment !1\led Health fiSk assessment of d1luted 

Task 1 Tech meal Information Resources TERA would prov1de ESR w•th a list of 

Technical rev1ew and deta•led comments relatmg to the rev1ew of the report ent1tled "A 

Techmcal rev1ew and detailed comments relating to the rev1ew of the report ent1tled "A 

Prov1de two presentat!Ons { 40-60 mms) on "Pnnciples for the nsk assessment of 

For Yealth Canada. TERA orgamzed and managed an expert SCientifiC letter rev1ew of a 

For Health Canada. Development of assessment matena!s to be used for evaluating 

For Health Canada development of a proposed approach for 1dent•fymg polymers that 

Rev1e\V and comment on new CatReg software tnterface 

Providing serv1c€s for Dept of Energy \DOE) Off1ce o' R1ver ProtectiOn (ORP) Tank 

Prepare comments on the tnchloroethylene IRIS document on issues related to cancer 

DE<velop and deliver an OEL presemat1on 

Prov1de support for development of dose-response analyses for tumongemc effects 

Conduct a letter peer rev1ew of a methanol cancer bioassay published as Soffnth e\ al 

Rvlf:'\v of mformatton regardmg acrylam1de m coffee 

TERA hosted and organized a workshop on the Endocnne D1sruptor Screenmg Program 

'Narks hop Ill of Beyond Sc1ence and DeciSions· to contmue the discuss:on toward a 

Prepare response to proposed HPV program tt:-st nile 

Develop whne paper on aggregate and cummulat.ve nsk for OPPT 

Prov1ce rev1ew of document regardmg rEcommended cleanup of broken mercury 

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27172.099

New Zealand Mtntslry of Health 

Ntckel producers research assocJatwn 

N1ckel producers research as.soc,atJon 

N1ckel producers research assoctat1or1 

Nickel producers research assocJatiOn Nobl1s Inc 

Noblts Inc NSF International NSF International NSF International NSF InternatiOnal 

Oh1o State Untvers1ty 

Ontano Mimstry of the Envtronment 

Pf1zer Global Research and Development 

PPG Industries PPG lndustnes Proctor & Gamble 

PSA Inc 

PSA Inc 

Oumn Emanuel Urquhart & Su!ltvan, LLP 

Sapphtre Group 

Shell Inc S1l1cones Envtronmental Health and Safety Council 

Scc1ety for RISK Analysts 

Society of T oxtcology 

State of Ma me 

State of New Mextco 

State of Oregon 

State of Texas State of Texas 

State of Texas 

State of Texas State of Texas 

State ofT exas 

State of Texas 

Develop publtcatJon based on the screentng level health assessment on exposure to 

RevieW and comment on draft manuscnpt on reference value for ntckel m ambtent atr 

Conduct a meta-analySIS and meta-regression of resplfatory cancer nsk followmg 

Momtor progress of research related to eva luatJon of nickel MOA provide advice to 

Rev1ew and rate proposals related to ntckel MOA: momtor progress of funded work, 

Facilitate the development of a WEEL 

(1) Evaluate of toxicity of emergmg contaminants to prov1de Sponsor With a sc!ent1f1c 

Run Cat Reg model for one set of data w1th chronic progressive nephropathy (CPN) as 

Add new data to ITER from NSF International 

Evaulate the MOA and safety studies on DMAA, contribute to the wnttng of a paper on 

Review of polymer tox1C1ty tnformatJon 

Present lecture on envtronmental nsk assessment at Oh10 State Un1vers1ty 

Review Ontano MOE approaches to settmg atr standards Conduct research mto how 

Provide support for development of dose-response analyses for tumongen1c effects 

Changed dioxane publ!ca\ton to open access 

Conduct Japanese study translation and anaylsis in part 

Determination of whether the current TTC l!m1ts are protect1ve for 

Manage reg1strat1on and workshops for 2011 TRAC conference 

Provrde ass1stance wtth onltne and onStte regiStration, catenng detailS and workshop 

Rev1ew mformat1on on petroleum coke and related matena!s to ass1st m understandtng 

Respond to rev1eNer comments. edJt acrylam1de manuscnpt rev1ew proofs 

Communicate toxicology related to smng a plant 1n Pittsburgh 

Gather and consoltdate SEHSC data m order to develop a summary of all relevant data 

Compile mformat1on on local contacts at untverslhes for student award for DRSG 

Host SOT 2013 Global Semor Scholar Exchange program The program alms 10 Examme whether current pestiCide residues have the potenltal to affect the lobster 

Prov1de a cornprehensJve techn1cai and regulatory support to New Mexico Env1ronment 

Rev1ew of 1n VItro study conducted by priVate party to determme likely btOavatlabrhty of 

Orgamze and hold a v10rkshop on technical and scientifiC Issues related to ozone 

Organrze and conduct sc1ent1ffc peer revleW of chem!cle-speclflc development support 

Add new data from TCEO to ITER in the ITER column 

Enter Hexavalent Chrom1un1 tox1crty factors from the chromrurn development S'-ippor! 

Organ1ze an external technrcal le:ter revtev, of the TCEQ draft Development Support 

Enter Nickel Tox1c1ty Factors from N1ck.el Development S'Jpport C>ocument or, the ITER 

Conduct a letter peer rev1ew of TCEO's rev sed ESL (effects screemnglevel) gllldelrnes 

Go

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PnPnv

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Go

Go

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Go

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27172.100

State of Texas 

State of Texas 

Steptoe 

Strategrc Regulatory Consulting 

Styrene lnformatron and Research Center Sudbury Integrated Nickel Operatrons. a Glen core company 

Summit Toxrcology 

ToxServ1ces 

T oxStrateg•es 

ToxStrateg1es 

T oxStrateg1es 

US Air Force 

US. Air Force 

US Army 

U S Army Corps a! Engmeers 

US Borax 

U S Consumer Product Safety CommiSSion 

U S Consumer Product Safety Comm•ss1on 

U S Consumer Product Safety Comm1ss:on U S Consumer Product Safety Comm1ss1on 

U S Consumer Product Safety CommiSSion 

U.S Consumer Proauct Safety Comrmss1on 

U.S Consumer Product Safety Commission 

U S Consumer Product Safety Commission 

U S Consumer Product Safety CommiSSIOn 

U S Consumer Product Safety CommiSSion 

U S Consumer Product Safety Comm•ss1on 

U S Environmental Protec!lon Agency 

U S Environmental Protect1on Agency 

U S Food and Drug Admin!Slraton 

US National lnslitute of Occupat:ona! Safety and Health 

U S Nat1onal Institute of Occupational Safety and Health 

U S Ncat1onal Institute of OccupatiOnal Safety and Hea!til 

U S Nat10nal L•brary of :v1ed1c1ne 

U S Nat:onal Library of Medlctne 

Letter peer rev1ew w1th follow up teleconference of sect1on 4 2 Camnogemc Potent1al of 

Letter peer rev1ew of sect10n 4.3 Carcmogemc Potential od the DSD for 1soprene 

Rev1ew Cal EPA chlorop1crm cancer nsK assessment 

Rev•ew draft MSDS forms provided by SRC for format and content Editmg of forms as 

Techmcal support for public workshop on mouse lung tumor mode of act10n 1ssues (for 

Rev1ew and comment on Quebec 24-hour nickel standard 

Work w1th Sean Hays of Summ1t Tox1cology to add b1omon1lonng equivalents data to 

Conduct literature search. ret neve papers. and wnte tox1cok1net1cs chapters for the 

Organ1ze and conduct a letter peer rev1ew of a rat 90-day study, conducted as part of a 

Organize and conduct a letter peer rev1ew of a mouse genorn1cs study, conducted as 

ITERate rev1ew of chromium VI 

Conduct focused sc1ence rev•ews of up to 6 chemical nsk assessments that assess 

Conduct a 4-day boot camp course on-s:te at WPAFB 

Form an expert panel and conduct a technical rev1ew of two occupational exposure levels 

2a Prepare slides m support of Tasl\1 (problem formulation)-- draft and !mal--

Develop manuscnpt on the prev1ous work we did m developmg an independent OEL for 

Develop and dehver a course on mJxtures nsk assessment Jssues 

Review and cornp1le data relatmg to human exposure to selected flame retardants 

Cconduct literature searches regarding the concentrations of spec1f1ed elements 

Conduct research regardmg the production and use of spec:fled ohthalates Results of 

Conduct research regarding the praduct10n and use of spec:ffed p!ast1cs WJth regards to 

Rev1ew ep1dem10logy and toxicology literature on common molds 

Review literature and prepare hazard charactenzat1on (tk and tox1c1ty sectwns) and 

Conduct a broad h1g!1-level letter peer rev1ew of the CPSC Chrome Hazard Adv1sory 

Organ•ze exposure data on !lame retardants mto database for use m exposure 

Conduct researcl1 regardmg the production of eng1neered wood products and research 

Conduct a letter peer revrew of a CPSC draft report on Nanomatenal Toxtclty and 

Rev1ew Technical Qualifrcatlons Document provrded by NHEERL Rev1ew evaluat1on 

TRAC Conference- TERA to manage social. reg1strat10n. oversee catenng at hotel and 

Organrze and condl:ct a 3 day boot camp course 

Create and publ1sh TRAC2016 webs1te. work With TRAC comm1t!ee and prov1de ons1te Create and publish webs1te work w1th TRAC comrn;ttee and prov1de ons1te 

G1ve presentat:on to NIOSH staff on the use of bas1c research :n develop:ng nsk 

Peer consultat1on work5hop for NLM to agree on ternmwlogy and defm!ttons 

Contmued lease, mamtenance and update of ITER database for use on TOXNET 

Go

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27172.101

Underwriters Lab- Envlfonment 

Vanadrum Producers & Reclarmers Assocralron 

Versar 

Versar 

Versar 

Vinyl acetate counc:l 

Waste Management 

Water Envrronment Research Foundatron 

QA of ingredrent revtews and gurde to preparing a toxrcologtcal assessment 

Evaluatron of K-Ras and ell mutauons H1 the lungs of Brg Blue mrce exposed to 

Revrew of Consumer Products Safety Commrssron on rnetai levels rn toys 

IRIS external peer revrew of hexachloroe!11ane 

Revrew CPSC assessment on cadrnrum rn chrldren·s metal jewelry 

Phase I rn potentral evaluation of vtnyl acetate MOA Conduct valtdatron. cytotoxrcrty 

Support the development of a collaborative effort on 1.4-dtoxane fisk assessment 

ldennfy and assemble data on health and ecologrcal endpornts to support an EPA rrsk 

N

Prrv

Go

Go

Go

Co

Col

N

27172.102

Toxicology Excelleme 

for Risk Assessment 

a nonprcfit UHporatiQn 

th.di.:atsd to thtS b.tJ'-l J:J.U 

c/wMcizy data for n':IJ; 11-aluJJ.s Understanding the Scien

of Mercury's ''Safe'' Do

Michael Dourson 

and 

Patricia Nance 

Toxicology Excellence for Risk Assessment (TERA) 

June 2004 

27172.103

Toxicology Excellence 

for Risk Assessment 

a nonprofit 

to Jhs uu 

obox.f,:fr, dQUJ for n»: 

The "Safe'' Dose Method As 

Defined by EPA: 

An Reference Dose (RfD) is ... 

... an estimate (with uncertainty spanning perhaps an 

of magnitude) of 

a daily (for RID) or continuous (for RfC) exposure 

human population (including sensitive subgroups) 

that is likely to be without an appreciable risk of 

deleterious effects during a lifetime. 

December 3rd, 2004, American Legislative Exchang

27172.104

TERA 

Toxicology Excellence 

for Risk Assessment 

a nonprofit .:orporanon 

10 be$1 uJtl 

"/tl:}x,itit;J dm.aforrlM: 

such as ... 

• the choice of the most appropriate No Observed 

Adverse Effect Level (NOAEL) or Benchmark Dos

(BMD) of the critical effect, usually from experimen

animal data, and 

• the choice of the appropriate Uncertainty Factors 

on a review of the entire database. 

December 3rd, 2004, American Legislative Exchange 

27172.105

/ "Safe" Compared 

Organization ICF ATSDR RIVM EPA WH

Name 

"Safe" Dose 0.3 to 1 0.3 0.1 0.1 0.2

Year 1998 1999 2000 2001 200

Seychelles, 

Study Seychelles Seychelles Seychelles Faroes, Seych

New Faro

Zealand 

NOAEL/BMD 

( 

0.9 to 3 1.3 1.3 0.9 to 1.5 1.

Uncertainty ,., 4.5 10 10 6.

Factors .) 

27172.106

TERA 

Toxitology Excellence 

for Risk Assessment 

<l nonpt'afit ctnporat:".Jn 

tJJ Jh6 best :mt 

cf!Dr.icit;\' 

14 

12 

10 

:;; 

10. 

:E 

C7J 

'iii 8 

3c 

>-

-o 

0 

_Q 

0 6 

C7J 

"' :;; 

"" C7J 4 

::l 

2 

0 

Contaminant Intakes in Faroe & Seychelle Islands 

(adapted from Dourson et. al., 2001) 

0 Mercury 

1 grain of sugar 

..,_____._ 

Infant Monkey Toxic Level 

Farces Adult: pilot whale & frsh Farces Child: breast-fed 

Ill PCBs 

ODDT 

Safe d

DDT 0

Hg (AT

Hg (EP

PCB: 

I 

' 

Seychelles Adult: fish 

The Faroe islands studies are very good at understanding a m

exposure. The Seychelle islands studies are very good at 

understanding exposures to primarily methyl mercury. 

December 3rd, 2004, American Legislative Exchange 

27172.107

Toxicology Excellence 

for Risk Assessment 

a m:mpMfit UlYpCrarkm d~dicat4d tQ thd b£$1 uu cO[toJJ~ity dc~aforn~kYalu•:; Percent 

Children 

Wi1h 

CNS 

Effects 

5% 

Obs=rved Range of CNS 

Effects in Faroe Children 

C.CVfidencc Limlt on Resp:ms=-~ 60,000 children at 1 0-fold 

above EPP® RfD (atBMG_) 

results i1 no more tmn 

3000 Ott risk6 

Respu"lSe 

0%L~------~~--~~~~--~~-------------------------------

0.1 1.0 BMD4,5 BM005 

RfD 

+-----+ 

Uncertainty Factor of 1 0 

MethylMercury Dose (ugJkg-day) 

December 3rd. 2004, American Legislative Exchan

27172.108

TERA 

Toxicology Excellence 

for Risk Assessment 

a n.:~nprcfit CO'rpormion 

dedlcat.td 1o tlu bt~JU vu 

41/!Ql.ltlzy dtJtafor riJ;k<talw~ What Might a Fish Advisory Lo

Like for Mercury? 

• First, calculate the Safe Fish Intake based on the 

Hg dose multiplied by a given body weight and 

divided by the measured Hg level in fish, for 

example, 0.1 ppm (EPA, 1997). 

• Safe Fish Intake 

=Safe Hg Dose x Body Weight 7 Fish Level 

== 0.1 ug/kg-day (EPA, 2001) x 60 kg 7 0.1 ug Hg/gram of 

== 60 grams of fish/day 

December 3rd, 2004. American Legislative Exchan

27172.109

T o;ticology Excellence 

for Risk Assessment 

a nonprofit cc;poratic:n 

dJJdico.t>dd to rh• bttJ.I uJJt (Jfto.u~f(? data for rlMl'alu.,; 

What Might a Fish Advisory Lo

Like for Mercury? 

• Second, translate this Safe Fish Intake into meals 

month or week 

• 60 kg of fish/day falls into the range of 30 to 100 

grams of fish per day and is consistent with eatin

three meals per week (Dourson and Clark, 1990). 

• This level would be expected to be "safe" for 

sensitive individuals. Higher fish consumption w

be appropriate for others. 

December 3rd, 2004. American Legislative Exchan

27172.110

Toxicology Excellence 

for Risk Assessment 

a nonprofit ccrparation 

drulico.Md to the bnl.UJ.<t oftoM~:-i'{'l data fer n'Jk Ja!:uJ 

The Fish Advisories Compar

"Safe" Dose 

(f.lg/kg-day) 

Advisory at 

0.1 ppm 

(meals per week) 

Advisory at I ppm 

(meals per month) 

0.3 

7 

4 

0.1 

,.., 

.) 

0.3 to 

7 to 

unlimit

4 to 1

Advisories that are inappropriately low compromise heal

removing a medically recommended protein source from 

food supply (e.g., Dourson et al., 2002). 

December 3rd. 2004. American Legislative Exchan

27172.111

Toxicology Excellence 

for Risk Assessment 

nonprofit l!07poratWn 

dddicautd to liM hll:.t uu 

cfto;r.irtirr data/QrtiJJr,aiiJM 

December 3rd, 2004, American Legislative Exchang

27172.112

Toricology Excellence 

for Rlsk Assessment 

a t!arpqn::tion 

to the uu 

oftcTi-ciu daJafor mJ: MJ:u.u 

References 

Dourson, M.L. and J.M. Clark. 1990. Fish consumption advisorie

Toward a unified, scientifically credible approach. Regul Toxicol 

Pharmacal. 12: 165-172. (EPA staff publication) 

Dourson, M.L, A.E. Wullenweber and K.A. 

Poirier. 200 I. Uncertainties in the Reference Dose for 

Methylmercury, NeuroToxicology 22 (5) (2001) pp. 677-689. 

(TERA staff publication) 

Dourson, M.L., et al. 2002. Comparative Dietary Risk: Balance 

the Risk and Benefits of Fish Consumption. Comments on 

Toxicology 8:335-536. (EPA cooperative agreement publication) 

U.S. EPA 1997. Guidance for assessing chemical contaminant 

data for use in fish advisories. Vol. 2: Risk assessment and fish 

consumption limits, 2nd ed. Office of Science and Technology, 

Office of Water. EPA 823-B-97-009. 

December 3rd, 2004, American Legislative Exchan

27172.113

TERA 

Toxicology Excellence 

for Risk Assessment 

a m:mpMfit ccrpo:ratWn d~Jit:-<JU;.d to?1h.8 b<J~t l.IU 

c/uu.ldfr da:a for mk value~ What is Toxicology Excellence for Risk Assessment (TERA) ? 

• TERA is a 50l(c)(3) non-profit research and 

education organization dedicated to the best 

use of toxicity data for risk values. 

• TERA :(j mission: protect public health 

> educating folks on risk issues 

> developing & communicating risk values 

> conducting independent peer reviews 

'.r improving methods through research 

• TERA founded in 1995 by former EPA staff 

with >45 years experience working in risk 

assessment and IRIS. 

December 3rd, 2004. American Legislative Exchang

27172.114

Partial History of Mercury's "Safe'' Dos

Date Action Tal{en on Mercury Michael Dourson

Involvement 

1980 EPA Develops RtD of 3 E-4 mg/kg-day Internal EPA reviewer 

1986 EPA Places RtD of3 E-4 mg/kg-day on IRIS EPA workgroup chair 

1995 EPA Places new RtD of I E-4 mg/kg-day on IRIS Co-author, EPA chair 

1998 ITER Peer Review for ICF Kaiser RID of 3 to I 0 E- Chair of independent 

4 mg/kg-day review meeting 

2000 TERA reviews RID for the State of Maine & notes Pro bono reviewer 

heavy PCB contamination ofmilk 

2000 TERA reviews EPA's Draft RtD for the National Paid Reviewer 

Food Producers Association 

2001 TERA publishes on research needs for the mercury Co-author 

RiD, sponsored in part by the EPRI 

2001 EPA Places New RID of l E-4 mg/kg-day on IRIS None 

27172.115

Toxicology Excellence 

for Risk Assessment 

a nonprofit eo1'pcrYatkm 

to 1he b1Ul uu 

b/Wxicitr da:aforn',.k"#a!udJ Understanding the Scien

of Mercury's ''Safe'' Do

Michael Dourson 

and 

Patricia Nance 

Toxicology Excellence for Risk Assessment (TERA) 

June 2004 

27172.116

TERA 

Toxicology Excellence 

for Risk Assessment 

a l'l<!llpYtJfit COtP'£'Yatum dMlicarr~d lo ths lu.JJuu 

oftoA.id\)' data for nM Yali.M~ The "Safe'' Dose Method As Defined by EPA: 

An Reference Dose (RfD) is ... 

... an estimate (with uncertainty spanning perhaps an 

of magnitude) of 

a daily (for RfD) or continuous (for RfC) exposure 

human population (including sensitive subgroups) 

that is likely to be without an appreciable risk of 

deleterious effects during a lifetime. 

December 3rd, 2004. American Legislative Exchange 

27172.117

Toxicology Excellence 

for Risk Assessment 

a nonprofit ct>rporatfqn 

dtt-diumuf to tho~ b6Jt u:..t CJ/t~!l.i~ip da1afQr nJJ: Yalw~ such as ... 

• the choice of the most appropriate No Observed 

Adverse Effect Level (NOAEL) or Benchmark Dos

(BMD) ofthe critical effect, usually from experimen

animal data, and 

• the choice of the appropriate Uncertainty Factors 

on a review of the entire database. 

December 3rd. 2004. American Legislative Exchange 

27172.118

"Safe" 

Organization 

Name ICF ATSDR RIVM EPA WH

"Safe" Dose 

0.3 to 1 0.3 0.1 0.1 0.2

( g/kg -day) 

Year 1998 1999 2000 2001 200

Seychelles, 

Study Seychelles Seychelles Seychelles Faroes, Seych

New Faro

Zealand 

NOAELIBMD 

0.9 to 3 1.3 1.3 0.9 to 1.5 1.

Uncertainty " 4.5 10 10 6.

Factors .) 

27172.119

TERA 

Toxicology Excellence 

for Risk Assessment 

ncnprofit t:Olpotati"n 

dddto:ated to ben uu 

c/WA{city dataf¢r n·:;; -.alw; 

14 

12 

>-

ro 10 "0 

:;; 

a. 

:c 

Ol 8 iii 

>-

"0 

0 

.0 

6 0 

0) 

-"' 

:;; 

a. 

Ol 4 

::l 

2 

0 

Contaminant Intakes in Faroe & Seychelle Islands 

(adapted from Dourson et. al., 2001) 

1 grain of sugar 

Infant Monkey Toxic Level 

Fa roes Adult: pilot whale & fish Fa roes Child: breast-fed 

[J Mercury 

Ill PCBs 

DDDT 

Safe d

/DDT: 0

I Hg (AT

I Hg (EP

PCB: 0

1 I 

Seychelles Adult fish 

The Faroe islands studies are very good at understanding a mi

exposure. The Seychelle islands studies are very good at 

understanding exposures to primarily methyl mercury. 

December 3rd. 2004, American Legislative Exchange 

27172.120

Toxicology Excellence 

for Risk Assessment 

a n"npra/it eq1pora1'icm 

dtulir::aud to thtJ ht~Jt ZJU oft0$.1~ff)l J~ro for n}); 11alU6J 

Percent 

Children 

With 

CNS 

Effects 

5% 

Observed Range of CNS 

Effects in Faroe Children 

ConfJdence Ur111t on Response.· 

60,000 children at 1 0-fold 

above EPA's RID (at BMDL) 

results in no more than 

3000 "at risk" 

Esttmateof Res~se Oo/o'~------~--------~-------------------------------------------

0.1 1.0 BMDL,..; BMD05 

RfD 

+-------+ Methyl Mercury Dose (ug/kg-day) 

Uncertainty Factor of 10 

December 3rd, 2004, American Legislative Exchan

27172.121

TERA 

Toxicology Excellence 

for Risk Assessment 

a ncnprofit 

dedkaMd to thtt bll'.it '1.11-8 

ofto:u"citp dat{:l {(}r n:,..: Yal!l!IJ 

What Might a Fish Advisory Lo

Like for Mercury? 

• First, calculate the Safe Fish Intake based on the 

Hg dose multiplied by a given body weight and 

divided by the measured Hg level in fish, for 

example, 0.1 ppm (EPA, 1997). 

• Safe Fish Intake 

=Safe Hg Dose x Body Weight+- Fish Level = 0.1 ug/kg-day (EPA, 2001) x 60 kg 0.1 ug Hg/gram off

60 grams offish/day 

December 3rd, 2004, American Legislative Exchan

27172.122

Toxicology Excellence 

for Risk Assessment 

a nonprofit curpon:tion. 

dedir:au1d to thd -b~M 11'-11' 

tJj:oAidt? doia/orn'M valu4;:, 

What Might a Fish Advisory Lo

Like for Mercury? 

• Second, translate this Safe Fish Intake into meals 

month or week 

• 60 kg of fish/day falls into the range of 30 to 100 

grams of fish per day and is consistent with eatin

three meals per week (Dourson and Clark, 1990)

• This level would be expected to be "safe" for 

sensitive individuals. Higher fish consumption w

be appropriate for others. 

December 3rd. 2004. American Legislative Exchan

27172.123

Toxicology Excellence 

for Risk 1\ssessment 

a ncnprofir 

d.adicaMd to be:-1 v.:wt. 

ofto:J.idty data feY ,.a[u,e;; 

The Fish Advisories Compar

"Safe" Dose 

(JL g/kg -day) 

Advisory at 

0.1 ppm 

(meals per week) 

Advisory at 1 ppm 

(meals per month) 

0.3 

7 

4 

0.1 

3 

0.3 to 

7 to 

unlimi

4 to 1

Advisories that are inappropriately low compromise hea

removing a medically recommended protein source from 

food supply (e.g., Dom·son et al., 2002). 

December 3rd. 2004. American Legislative Exchan

27172.124

Toxicology Excellence 

for Risk Assessment 

a nonprofit 

to thd. bul UJ;tJ 

ofurdcfp dawfor riJk 

Extra slides 

December 3rd. 2004. American Legislative Exchang

27172.125

TERA 

Toxicology ExceUence 

for Risk Assessment 

a nonp:l'ojir t:Otporaticn J.ed:~CJ!<~d t" th~ heJt u:.s 

afloAidtp data for riJ.k "<ili.J4.j 

References 

Dourson, M.L. and J.M. Clark. 1990. Fish consumption advisorie

Toward a unified, scientifically credible approach. Regul Toxicol 

Pharmacal. 12: 165-172. (EPA staff publication) 

Dourson, M.L, A.E. Wullenweber and K.A. 

Poirier. 200 I. Uncertainties in the Reference Dose for 

Methylmercury, NeuroToxicology 22 (5) (2001) pp. 677-689. 

(TERA staffpublication) 

Dourson, M.L., et al. 2002. Comparative Dietary Risk: Balance 

the Risk and Benefits of Fish Consumption. Comments on 

Toxicology 8:335-536. (EPA cooperative agreement publication) 

U.S. EPA. 1997. Guidance for assessing chemical contaminant 

data for use in fish advisories. Vol. 2: Risk assessment and fish 

consumption lim its, 2nd ed. 0 ffice of Science and Technology, 

Office of Water. EPA 823-B-97-009. 

December 3rd. 2004. American Legislative Exchan

27172.126

Toxicology Excellence 

ror Risk Assessment 

a n'mprelit corpcran<nt 

dtdi.r:awi to th., bea US# 

<J/toxitir;y data /br nNe. valWJ 

What is Toxicology Excellence 

for Risk Assessment (TERA) ? 

• TERA is a 50 I ( c )(3) non-profit research and 

education organization dedicated to the best 

use of toxicity data for risk values. 

• TERAs mission: protect public health 

> educating folks on risk issues 

> developing & communicating risk values 

> conducting independent peer reviews 

> improving methods through research 

• TERA founded in 1995 by former EPA staff 

with >45 years experience working in risk 

assessment and IRIS. 

December 3rd, 2004, American Legislative Exchan

27172.127

Partial History of Mercury's "Safe" Dos

Date Action Taken on Mercury Michael Dourson

Involvement 

1980 EPA Develops R1D of3 E-4 mg/kg-day Internal EPA reviewer 1986 EPA Places RfD of3 E-4 mg/kg-day on IRIS EPA workgroup chair 1995 EPA Places new RfD of I E-4 mg/kg-day on IRIS Co-author, EPA chair 

1998 ITER Peer Review for ICF Kaiser RfD of 3 to 10 E- Chair of independent 

4 mg/kg-day review meeting 

2000 TERA reviews RfD for the State of Maine & notes Pro bono reviewer 

heavy PCB contamination ofmilk 

2000 TE'RA reviews EPA's Draft RtD for the National Paid Reviewer 

Food Producers Association 

2001 TERA publishes on research needs tor the mercury Co-author 

RID, sponsored in part by the EPRI 

2001 EPA Places New RfD of I E-4 mg/kg-day on IRIS None 
133 


27172.128

27172.129

Summary 

• An independent science panel conducted a 

consultation of a proposed chromium VI Mode of 

Action (MOA) plan. 

• Panel gave suggested improvements, but commented 

that research like this is the future of risk assessment. 

• Suggested studies are being completed. • Panel will peer review study results . 

... Peer consultation is credible based on adherence 

to COl procedures & use of known experts 

... Targeted research is public health protective and 

consistent with EPA {2005} Guidelines. 

27172.130

Independence 

is essential for a credible review 

Administrative ground rules to protect independence of the 

process 

• Measures to avoid influence of interested or involved parties o

the outcome of the expert consultation/review. 

" TERA independently selects panel, runs meeting, and prepare

report 

" Sponsors, authors, and other interested parties do not have 

direct communication with the panel. 

27172.131

Cr(VI) Review: The Research Plan 

Research plan that describes a 6-phase research program to 

delineate the MOA for Cr VI following oral exposure including 

- 90-day drinking water study 

- Genomics evaluation via microarray analysis 

- PBPK modeling 

-In vivo mutation analysis -In vitro high content imaging analysis 

- Integrating MOA analysis into risk assessment 

27172.132

The Charge to Reviewers 

• The charge is a critical element of each peer review that 

serves as an outline for the meeting discussion. 

• Purpose of the charge is to identify the key scientific issues 

and guide the panel to thoroughly consider each one; leading 

to independent panel conclusions. 

• Developed by TERA with input from the authors and sponsors. 

27172.133

Cr VI Review: The Charge 

The 3-page panel charge addressed the research plan: 

-Mode of Action (MOA) Hypothesis 

-General Review of the Study Design -Questions on Specific Studies 

The full charge is available in the final peer review report, which 

available at ,, ........ .. 1r..'-11..A• ........ b/l ........ ,;t!'IV'IIIt .. llll.d

Meeting report is also available at the website above and will be 

submitted to the public comment docket. 

27172.134

Cr VI Review: Required Expertise 

Based on its review of the research plan, TERA determined 

that the following types of expertise were required for the 

panel: 

- Risk assessment, particularly use of MOA data in risk assessment, 

PBPK modeling, 

Chromium MOA research design and conduct 

- Expertise in specialized analysis such as HCA, MRI, genomics etc 

- Statistics 

• All panelists were screened against COl concerns with 

sponsors, authors and principal investigators 

27172.135

Cr VI Review: The Panel 

• Michael Dou rson, Toxicology Excel!. for Risk Assess . 

• Jeffery Fisher, University of Georgia 

• David Gaylor, Gaylor and Associates 

• Kirk Kitchin, Environmental Protection Agency • Bette Meek, Health Canada/University of Ottawa 

• Xianglin Shi, UniversityofKentucky • Patrick Winter, washington University 

27172.136

Cr VI Review: The Results 

-

Mode of Action 

The panel agreed that dose response and temporal relationships 

should be examined simultaneously for the following key events: 

-cellular uptake of chromium, 

-oxidative stress, -DNA adducts, -DNA inter- and intra-strand crosslinks, -mutation, 

-cytotoxicity, and 

-cell proliferation. 

Furthermore, since oxidative stress might be a primary key event

the panel recommended that the research must include more 

measurements of this endpoint. 

27172.137

Cr VI Review: The Results 

-

Mode of Action (2) 

The panel recommended measurement of DNA interaction, such 

as DNA chromium adducts and DNA inter- or intra-strand 

cross! inks. 

Some panel members also recommended measuring circulating 

inflammatory markers ... 

... although it was noted that the microarray study would identify 

inflammatory changes in the target tissue if those changes were 

regulated transcriptionally

27172.138

Cr VI Review: The ResultsStudy Design 

The panel recommended adding 5 animals/dose, for a total of n=lO, for 

least the histopathology study to improve the study sensitivity to identify 

an effect ... 

... The panel noted that the proposed number of animals was proba

adequate for defining the shape of the dose-response curve for continu

data; but was marginal for pairwise comparisons of quanta/ da

The increased number of experimental animals may also allow som

of the suggested testing for oxidative stress endpoints. 

27172.139

Cr VI Review: The ResultsStudy Design (2) 

The panel agreed with the authors to run the 90-day study using 6 

dose groups (including the control) ... 

... but recommended two unspecified low doses plus the top three 

doses in the NTP bioassay

The panel agreed with the authors that the MOA would not likely be 

different between males and females and, as such, concurred that 

using only females in the research was sufficient. 

27172.140

Cr VI Review: Next Steps 

TERA will organize and conduct peer reviews of 12 MOA studies in 

transparent and independent fashion. 

Study/Paper Ready for Review 

Mouse 90 day November, 2010 

Mouse genomics, Mouse DNA Adducts 

Rat DNA Cr Adducts, Mouse & Rat PK 

PK Data, Human PK 

Rat 90 day, Rat Genomics 

In vivo Mutation, Mode of Action 

High Content Imaging 

January, 2011 

March, 2011 

April, 2011 

27172.141

Cr VI Review: Next Steps 

• The panel for each review will be composed of 3 to 5 

appropriate experts and screened for COl issues ... 

... We anticipate having to add reviewers in areas of toxicokinetic

modeling/ genomics, genotoxicit'J; and high content imagin

• TERA will create a single core set of charge questions. Separate 

reports will be prepared for each review, and will include the 

combined reviewer written comments for each question. 

• EPA's and others' thoughts on areas to be covered in these 

charge questions would be welcome. 
147 


27172.142
148 


27172.143

27172.144

Toxicology Excellence for Risk 

Assessment (TERA) 

Statement of Purpose & Mission 

Founded in 1995 

Toxicology Excellence for Risk Assessment (TERA) is a non-profit, 501(c

corporation organized for scientific and educational purposes. 

The mission of TERA is to support the protection of public health by 

developing, reviewing and communicating risk assessment values and 

analyses, improving risk methods through research, and educating risk 

assessors and managers and the public on risk assessment issues. 

27172.145

TERA 

Staff of board certified toxicologists with extensive experience in 

risk assessment, toxicology, and peer review. 

• Prepare high quality risk assessments and organize expert pee

reviews 

• Improve the underlying methods for risk assessment through 

research and publication 

• Distribute peer reviewed risk values through the International 

Toxicity Estimates for Risk (ITER) database- ........ bl 

.. Train others on state-of-the-science risk methods. 

Mix of work is 65% government & NGO, and 35% industry & 

Industry related 

27172.146

What is Peer Review? 

• For risk assessment products, it involves an in-depth 

assessment of the assumptions, calculations, alternate 

interpretations, methodology, and conclusions. 

• Peer review panels seek to reach consensus or common 

agreement regarding the adequacy of the product reviewed. 

27172.147

TERA's Independent Peer Review 

Process 

1. Scientific screen of the documents to insure they are ready 

for review, and to identify critical scientific issues and 

questions for development of the charge and needed 

expertise for panel. 

2. Develop the scientific charge to the panel. 

3. Identify appropriate expert candidates and select panel 

members. Identify conflicts of interest and biases. 

4. Schedule meeting and logistical arrangements. 

5. Prepare meeting report of discussions, conclusions, and 

recommendations. 

6. Distribute the results to the public. 

27172.148

Panel Selection Procedures 

• Identification of scientific expertise necessary 

to address key issues in charge. 

• Search for appropriate candidates, evaluate 

credentials 

• Contact most promising for interest and 

availability. Query them on conflicts of 

interest and biases. 

• Select a panel that is balanced with regard to 

necessary disciplines and has a diversity of perspectives. 

27172.149

Conflict of Interest (COl) 

An independent panel is essential for a credible 

scientific review 

TERA follows National Academy of Sciences (NAS) procedures for 

panel selection and conflict of interest. 

• NAS defines a conflict of interest as "any financial or other 

interest which conflicts with the service of the individual 

because it {1} could significantly impair the individual's 

objectivity or (2} could create an unfair competitive advantage 

for any person or organization . ... The term 'conflict of interest

means something more than individual bias. There must be 

an interest, ordinarily financial, that could be directly affected 

by the work of the committee." 

27172.150

Bias 

• "Questions of lack of objectivity and bias ordinarily relate to 

views stated or positions taken that are largely intellectually 

motivated or that arise from the close identification or 

association of an individual with a particular point of view or 

the positions or perspectives of a particular group." [NAS] 

• Biases are not necessarily disqualifying, but a balance of 

potentially biasing backgrounds or professional or organizatio

perspectives is needed. 

• Some potential sources of bias may be so substantial that the

would prevent an individual from considering others 

perspectives or relevant evidence contrary to their strongly 

held position. 

27172.151

Meeting Structure 

1. Introductory Remarks, Ground Rules and 

Conflict of Interest discussion 

2. Short presentation by authors 

3. Panel asks clarifying questions of authors 

4. Chair facilitates in-depth discussion of each 

charge question by panel. Authors available to 

answer panel questions. 

27172.152

Michael L. Dourson, PhD, DABT, FATS 

Toxicology Excellence for Risk Assessment (TERA) 

Dr. Dourson was selected for this panel for his expertise in dose-response assessme

& mode of action analysis, and familiarity with U.S. EPA's carcinogen risk assessmen

guidelines. In addition, Dr. Dourson has extensive experience effectively chairing 

panels. 

Disclosure: Dr. Dourson is the President of TERA, which is under contract with 

ToxStrategies to independently organize and conduct this peer review. See further 

discussion on website. In 1995, Dr. Dourson testified in a legal case about the risk 

assessment approach used by U.S. EPA to develop the maximum contaminant level 

(MCL) for chromium. TERA has concluded that this is not a conflict of interest or a 

bias because Dr. Dourson's testimony was limited to explaining how existing U.S. EP

standards were derived, and he did not provide his professional opinion on the 

toxicity of chromium at concentrations under discussion. 

27172.153

Jeffery Fisher, PhD; FATS, University of Georgia 

Dr Fisher was selected for this panel for his expertise in the development of 

physiologically based pharmacokinetic models and his experience in serving 

panels of expert scientists in review of risk assessments. Disclosure: None. 

David Gaylor, PhD, FATS, Gaylor and Associates 

Dr Gaylor was selected for this panel for his expertise in biostatistics, doseresponse assessment, and for his experience in serving on panels of expert 

scientists in review of risk assessments. 

Disclosure: Dr. Gaylor indicated that he is a past employee of General Electric

Co. and General Dynamics, Co. In addition, he has consulted in the past with 

3M Corporation (2002-May 2009). All three companies are currently membe

of Aerospace Industry Association, which is the Sponsor of the review. TERA 

concluded that there is no conflict of interest or bias because none of the pa

work involved chromium and Dr. Gaylor has no current, ongoing financial 

relationship with these companies. 

27172.154

Kirk Kitchin, PhD, DABT, U.S. EPA 

Dr. Kitchin was selected for this panel for his expertise in metals carcinogenici

cancer mode of action research, and use of genomics in risk assessment 

Disclosure: None. 

Bette Meek, M.Sc., University of Ottawa 

Ms. Meek was selected for this panel for her expertise in genotoxicity, doseresponse assessment, and mode of action analysis in a regulatory context. In 

addition, Ms. Meek has experience in serving on panels of expert scientists in 

review of toxicity assessments. 

Disclosure: None. 

27172.155

Xianglin Shi, PhD, University of Kentucky 

Dr. Shi was selected for this panel due to his expertise in chromium mode of 

action research, particularly for his understanding of the role of oxidative stress 

and DNA damage in chromium toxicity. Dr. Shi also has expertise in genomics, 

proteomics, transcriptional analysis, and imaging. 

Disclosure: None. 

Patrick Winter, PhD, Washington University 

Dr Winter was selected for this panel for his expertise in molecular imaging. 

Disclosure: None. 

27172.156

WEST VIRGINIA TESTING ASSESSMENT PR

Michael Dourson 

Toxicology Excellence for Risk Assessment 

British Society of Toxicology 

April 20, 2015 

St. Johns Hotel, Solihull, England 
162 


27172.157

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27172.161

hat Level is Safe? 

TASK: Independently evaluate the safe levels 

of MCHM and PPH for all members of the 

population for all intended uses 

• Comprehensive literature review of relevant 

toxicological literature (Adams, 2014) 

• Health Effects Expert Panel on March 31, 

2014 in Charleston, West Virginia: evaluate 

available toxicity data and health advisories 

27172.162

What as Spilled? 

" Crude MCHM (Eastman) 88.5% 

- Used in coal processing 

The Crude MCHM is a mixture containing: 

• 4-Methyl-1-cyclohexanemethanol (MCHM) @ 68-89% {w/w); 

• 4-(Methoxymethyl) cyclohexane methanol (MMCHM) @ 4-22% 

(w/w); 

• Methyl 4-methylcyclohexane-1-carboxylate (MMCHC)@ 5% 

(w/w); 

• 1,4-Dimethyl cyclohexanedicarbonate (DMCHDC) @ 1-2% (w/w); • 1,4-Cyclohexanedimethanol (CHDM); and • Methanol (MeOH) @ 1-2% (w/w). 

27172.163

Specific Charge Questions to Pane

1. Given data now available, what would be 

appropriate screening levels for MCHM and PPH in 

drinking water? 

2. What additional data, analyses, or studies might 

reduce uncertainty and provide greater 

confidence? 

3. How should the presence of multiple chemicals in 

the release to the Elk River be considered? 

4. Are the screening values protective for all potential 

routes of exposures (i.e., ingestion, dermal and 

inhalation)? 

5. Other issues? 

27172.164

WV TAP Expert Panel 

(affiliations listed for identification purposes only) 

Expertise in toxicology, risk assessment, deriving risk 

values for water contaminants, and water quality and 

distribution systems. 

• Dr. Michael Dourson, chair, Toxicology Excellence for Risk 

Assessment, Cincinnati, OH, USA 

• Dr. Shai Ezra, Mekorot, Israel National Water Company Ltd, Te

Aviv, Israel 

• Dr. James Jacobus, Minnesota Department of Health, Saint 

Paul, MN,USA 

• Dr. Stephen Roberts, University of Florida, Gainesville, FL. USA 

• Dr. Paul Rumsby, National Centre for Environmental 

Toxicology at WRc pic, Swindon, UK 

27172.165

Available Data on MCHM 

-very limited 

• Crude MCHM, acute gavage in rats, 250- 1000 mg/kgday; Possible hematuria (Eastman 1998, 1999) 

• Pure MCHM, gavage in rats Eastman (1990) 

- 0, 25, 100, and 400 mg/kg/day, 5 days a week, for 4 

weeks 

- 400 mg/kg/day- anemia (FL kidney and liver effects 

-NOEL 100 mg/kg/day 

- Proprietary, OECD and GLP 

27172.166

Critical Effect of MCHM? 

Absolute kidney weights for male rats heavier at 25 mg/kg. 

Relative kidney weights statistically heavier for all treated males. 

No differences were seen in female rats. Relative and absolute changes might be adverse. However: 

- Higher doses did not show statistically significant increase 

in absolute kidney weights; 

- Kidney weights, both relative and absolute, did not show a 

dose-related trend; and 

- Low dose effects did not have matching clinical changes or 

histopathology, which when compared with organ weight 

changes, are more definitive. 

27172.167

CDC Advisory MCHM 

• January 9, 2014, January 20, 2014 

• Methodology: EPA OW advisory methods (Donohue and 

Lipscomb, 2002) 

OW Advisory levelS (NOEl x BW) I (UF x Intake) 

• NOEL: 100 mg/kg-day (Eastman, 1990) 

• Consumption: 

• BW of a child: 10 kg 

• intake: lliter/day, water intake for child. 

• Uncertainty Factors (UF): 1000 (UFA, UFH, UFDB) 

or 

CDC 

27172.168

Plumbing System Flushing: REAL-TIME Syndromic Surveillance Would Ha

Revealed Illnesses were being Caused 

25 

20 

15 

10 

KCHD Syndrom

Surveillance Jan. 2

Patients 

5 

0 

50 

40 

30 

20 

10 

0 

t-....\<J.> rl>rv rl>t.>< rl>ro 

Symptom Onset Date 

Flushing begins CDC/DHHR Hospita

Chart Rev. Apr. 201

v v v 

Whelton eta/, (2014) Submitted. Symptom Onset Date 

27172.169

V TAP Expert Panel 

• CDC used traditional methods and reasonable assumptions 

develop their screening levels 

• The Panel considered additional exposure routes: 

- Direct ingestion of water, including formula-fed infants 

- Inhalation from showering and cooking 

- Skin exposure to water uses in the house 

- Incidental exposures, including brushing teeth, watering plant

• The Panel determined formula-fed infants to be the most 

highly exposed population/life stage 

27172.170

Panel Advisory for MCHM 

• Methodology- u 

• NOEL: 100 mg/kg-day (Eastman, 1990) 

71 m 

• Consumption: 0. 

rmu a 

., 

5 

e) 

ex 

• Uncertainty Factors (UF): 1000 (UFA1 UFH, UFDB) 

nee 

re ( e., 

27172.171

Panel Calculated Level for MCHM 

OW Advisory Level= (NOEL x BW) I (UF x Intake) 

--3> OW Advisory [(NOEL) I (UF x lntakeiBW)] · Exposure f

where: 

OW Advisory Level is the drinking water advisory level (!lgiL or ppb) 

NOEL= No Observed Effect Level in the experiment= 71 mglkglday 

UF =uncertainty factors (unitless) 

• for differences between humans and animals (lOx) 

• to account for more sensitive humans (lOx) 

• to account for in the toxicity database data {lOx) 

Intake I BW =water consumed daily by a bottle-infant {0.285 L/kg·d) 

Exposure factor= to account for other sources of exposure {0.5) 

4-week DW Advisory Level= (NOEL) I (UF x lntakeiBW) ·Exposure fac

= [{72 mglkgld)] I [(lOxlOxlO) = 0.0072 (rounded to 0.07) 

0.07 mglkg-day I {0.285 Llkg·day)] · 0.5 = 0.123 mgiL (rounded to 120 J

27172.172

PPH and DiPPH 

• CDC 

- PPH: 1200 ppb 

- DiPPH: Limited data suggest similar or lower toxicity, 

the PPH screening value would also be protective for 

DiP PH. 

• Expert Panel 

- PPH: 880 ppb 

- DiPPH:260 ppb 

27172.173

What about the Mixture? 

• Toxicity data on specific chemical mixtures are rarely 

available. 

• Toxicity of mixtures in spill could be approximated by a 

simple additive approach (MCHM, PPH, DiPPH, etc) 

following US EPA's mixtures guidelines (US EPA 1986 and 

2000) 

• For example, it is reasonable to assume that the toxicity 

of the mixture (Crude MCHM) would be similar to the 

pure MCHM. 

I vtnr.JNIA TESTING ASSESSME

27172.174

Research Needs 

1. Determine MCHM potential to cause skin irritation. 

2. Conduct toxicology studies for MCHM in pregnant 

animals. 

3. Organize all available data on exposures and health 

effects (from immediately following the spill) to 

facilitate the estimation of initial conditions. 

4. Pending results of #2 and #3, consider the need for 

long term health effects study. 

5. Determine chemical fate and transport within the 

treatment plant and water distribution system. 

27172.175

US National Toxicology Program 

Research Progress 

February 2015 Update for 5-Day In Vivo Micronucleus Assay 

• The results for all three chemicals were negative; none 

increased the frequency of micronucleated red blood cells in 

male rats after oral administration for five days. 

December 2014 Update for Prenatal Developmental Toxicity 

• 150 to 900 mg/kg-day of MCHM was gavaged to pregnant 

Harlan Sprague Dawley rats from gestational day 6 to 20. 

• The results indicate increased post-implantation pregnancy 

loss occurred at doses that induced maternal toxicity. 

27172.176

Summary 

> The WV TAP Expert Panel reviewed the CDC and WV screening 

values and reached conclusions that are not incompatible with 

the CDC values. 

> Panel used more refined methods, including an adjustment to 

account for dermal and inhalation exposure. 

> MCHM concentrations below 120 ppb are safe for ALL membe

of the community for ALL intended uses for up to 1 month of 

exposure. 

27172.177

Acknowledgements 

• WV TAP Technical Team 

-Jeffrey Rosen, Program Manager 

-Andrew Whelton/ University of South Alabama 

-Craig Adams, Utah State University 

• Funding and support from: 

-West Virginia Bureau for Public Health (WVBPH-West Virginia Department of Health and Human 

Resources (WVDHHR). 

27172.178

More Information and References 

Expert Panel Report 

• 

WVTAP Web Site 

• 
184 


27172.179

('.. .. V') 

c 

0 

·-

27172.180

WVTAP Literature Review 

Adams, C., Whelton, A., Rosen, J. {2014) "Health 

Effects for Chemicals in 2014 West Virginia 

Chemical Release: Crude MCHM Compounds, PPH 

and DiPPH/' 

Public report by West Virginia Testing Assessment 

Project (WV TAP} to the State of West Virginia. 

Very limited data for MCHM 

27172.181

Additional Question by WV for the 

Expert Panel 

. 

I 

-CDC initial screening value of 1 ppm (1,000 ppb) 4

MCHM 

- WV screening level later set at 10 ppb 

27172.182

it 

--CDC initial screening value of 1 ppm 

--WV screening level later set at 

• Panel derived short-term advisory of 

• Protect all portions of the population (inc. infants, children, 

pregnant women) 

• Protect for exposures from direct ingestion, inhalation from 

showering and household water use, dermal exposure. 

• Appropriate for apply to exposure situations of 1 day up to 

3 months. 

27172.183

What Was Spilled? 

• DOW PPH Basic 7.3% 

It is reported that the source of the Freedom Industries' PPH was 

DOW PPH Basic DOW Basic contains: 

• Dipropylene glycol phenyl ether (DiPPH) concentration at between 40% 

and 85%; 

• Propylene glycol phenyl ether (PPH); and 

• Other compounds. 

27172.184

Key Studies for PPH 

• Oral toxicological data on PPH include: 

-A 90-day drinking water study (and 28-day range 

finding study) in rats {OECD 408- BASF AG 1997a) 

u u d EL 

-A two-generation study drinking water study in rats 

{OECD 416- BASF 2000) 

-A prenatal developmental toxicity studies using 

gavage with rats (OECD 414- BASF AG 2000) and 

rabbits (OECD 414- BASF AG 1995 and OECD 2006c) 

u d 

- In vitro and in vivo genetic toxicity tests 

27172.185

WV TAP Panel Screening Level for PP

DW Advisory Level::; (NOEL x BW) I (UF x Intake) ~ DW Advisory Level::; [(NOEL) I (UF x lntakeiBW)} · Exposure fa

where: 

DW Advisory Level is the drinking water advisory level (~giL or ppb) 

NOEL= No Observed Effect Level in the experimental species = 146 

mglkglday (from 90-day OW study) 

UF =uncertainty factors (unitless) 

for differences between humans and animals (lOx) 

to account for more sensitive humans (lOx) 

to account for in the toxicity database data (3x) 

Intake I BW =water consumed daily by a bottle-infant (0.285 Llkg·d) 

Exposure factor= factor to account for other sources of exposure othe

ingestion (i.e., inhalation, dermal) (0.5) 

90-day OW Advisory Level= (NOEL) I (UF x lntakeiBW) ·Exposure fac

= [(146 mglkgld)] I [(10x10x3) = 0.49 (rounded to 0.5 for a short term 

0.5 mglkg-day I (0.285 Llkg·day)] · 0.5 = 877 (rounded to 880 ~giL or p

27172.186

No Observed Adverse Effect Level 

(NOAEL) = 40 mg/kg-day teratology 

study in rats, maternal toxicity 

Uncertainty Factor= lOH, lOA, 100 

Intake= lliter water/day (child) 

Body Weight= 10 kg (child) 

Ingestion of water only 

PPH Screening Level = 1200 ppb 

NOAEL = 146 mg/kg-day ( (ECHA, 2014), 

90-day OW study in rats 

Uncertainty Factor = lOH, lOA, 30 

(missing second repeat dose tox study) 

0.285 liters/kg bw (95th percentile) 

Formula fed infant most exposed life 

stage 

RSC = 0.5 to allow for other possible 

sources and routes of exposure (i.e., 

dermal, inhalation) 

PPH Short-Term Health Advisory= 880 

ppb 

lOH lOx human variability; lOA= lOx animal to human extrapolation; 100 lOx doto bose sufficiency 

27172.187

WV TAP Panel Screening Level for DiP 

OW Advisory Level:::; (NOEL x BW) I (UF x Intake) 

-7 OW Advisory Level:::; [(NOEL) I (UF x lntakeiBW)] ·Exposure fac

where: 

OW Advisory Level is the drinking water advisory level (~giL or ppb) 

NOEL= No Observed Effect Level in the experimental species= 146 

mglkglday (from 90-day DW study) 

UF =uncertainty factors (unitless) 

for differences between humans and animals (10x) 

to account for more sensitive humans (10x) 

to account for in the toxicity database data (lOx) 

Intake I BW =water consumed daily by a bottle-infant (0.285 Llkg·d) 

Exposure factor= factor to account for other sources of exposure othe

ingestion (i.e., inhalation, dermal) (0.5) 

90-day DW Advisory Level= (NOEL) I (UF x lntakeiBW) · Exposure fact

= [(146 mglkgld)J I [(lOxlOxlO) x (0.285 Llkg·d)] · 0.5 ~ 256 or 260 11giL 

Note short term Reference Dose not calculated since toxicity is based on PP

27172.188

Toxicology Excellence 

for Risk Assessment 

a nonpriJfit cCJrpatation 

dedica16d to 1116 btut u:;s 

ofto-,;icity dmafor nJk Palus; Environtnental Risk Assessment. .. 

... in the 2Jst Century 

l 

27172.189

Toxicology Excellence 

for Risk Assessment 

a eorporation 

dddicated to thtt bsst uu 

oftoxicizy 

Seminar Overview 

• Know traditional risk methods ... cold 

Think like a clinician 

Challenge non-experts 

" Use contemporary methods often 

- BMD, categorical regression, CSAF, PBPK 

" Create future by collaboration and research 

I lang together, or hang separately (paraphrased B. Fr

Focus on collaboration among agencies 

27172.190

Do You Know the Traditional Method

Adapted from EPA, 1999 

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or Interest Point of 

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0% I I ,,., . ---'-'---1-'-1-' ------- RSD RID LED10 11 ED10 

j....- UF _.,..I Dose (PBPK) 

27172.191

TERA 

Toxicology Excellence 

for Risk Assessment 

a ncnprofit 

dedlcaMd to thd be;t we 

Do You Know the Traditional 

Methods? 

• If we had a array of effects that were all linked 

one syndrome of toxicity, what would be the po

of departure for a dose response assessment? 

• If we had only 8 fingers, what would be the 

uncertainty factor covering experimental anima

human and within-human variation? 

27172.192

Toxicology Excellence 

for Risk Assessment 

a nonprofit Gorporation 

dedicattd to thG be.Ji uM 

qftorticity data/or n'Jk valwu 

Traditional: Critical Effect 

• Risk assessment is ... preventive medicine. Th

involve clinicians in judgment of critical effect, 

at least think like one ... 

o ... but do not let them do the dose response assessmen

o 25 years in the clinic does not prepare one to estimate 

RtD, even if the critical effect appears to lie within y

area of expetiise. 

• Critical effect is ... 

27172.193

Nonactverse 

Effect 

Inhibition of 

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thyroid 

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FIGURE 5-2 Committee's suggested mode-of-action model for perchlorate toxicity in humans 

indicating first adverse effect in the continuum. 

NAS, 2005. Health implications of perchlorate ingestion. 

27172.194

TERA 

Toxicology Excellence 

for Risk Assessment 

a nonprofit ctnporation 

d6dicated til the beJt 1m~ oftoxiai'J' data for n·sk valw~l.! Traditional: Uncertainty Factors 

• Uncertainty factors for within human, experim

animal to human, LOAEL to NOAEL, subchro

to chronic and lack certain data. 

• Misconceptions: 

- Studies with small "n" are not useful. 

An uncertainty factor of 1 0-fold with human data is 

not enough. 

27172.195

v 

Ul 

c 

0 

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Areas of Uncertainty to Consider in 

Noncancer Dose Response Assessmen

Chronic Human / 

Chronic Animal 

Sub-chr

Animal 

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Reproductive 

Dose 

27172.196

!00 ~ 80 

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u 

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Factor of 10 Enough? 

Figure Sa. Cumulative Response as a function of Dose for Humans 

and Rats. Data are hypothetical, but approximate real situations. 

-

• 0.1 RID 

Human NOAE! 

orBMD ' 

I ' 

I 

I 

I 

I 

I 

I 

I 

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I 

I 

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I 

I 

I 

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I 

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---Human 

-- Rat 

Animal NOAEL 

I L • ...-----or BMD 

.. UFA .. 

___ , ______ ; 

10 100 

Dose 

Dourson, M.L., G. Charnley and R. Scheuplein, 2002 

27172.197

Factor of 10 Enough? 

Figure Sb. Response as a function of Dose for Humans and Rats. 100 

90 

80 

70 

11) 60 ~ ;::::; 

&so ~ 11) 

0::: 40 

30 

20 

10 

0 

0.01 t 

RID 

Hypothetical data are the same as in Figure Sa. 

Human NOAEL or BMD ,~ I \ I I 1 1 --lluman I I I ; ---Rat I I I I I I I I / I I I I 1 t I I I I I I I 

I I 

I I 

/ I i 1 Animal NOAF:L or BMD 

0.1 

I 

t 

UFA I .. 

I 

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------- ~-Dose 10 

I 

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100 

27172.198

45 

40 

35 

Q) 30 IZl 

c 25 R 

20 IZl Q) ~ 15 I 

10 j 

0,01 t 

RID 

Factor of 10 Enough? 

Figure 6a. Response as a function of dose for 

humans of different sensitivities. Hypothetical 

data for humans are the same as in Figure 5b. 

UFH 

0.1 

\ 

\ 

\ 

\ 

\ 

\ 

\ 

.. \-·· 

. \ 

-=----..,.--------~-,_;-

_________ _,__ 

10 

Dose 

Sensitive 

27172.199

Toxicology Excellence 

for Risk Assessment 

a nonprofit eorporatlon 

dedicat6d to tfM best we 

of toxicity data for n'$k11ab1e.J 

. 

. 

Clear advantages and disadvantages exist in the u

a benchmark dose (BMD) 

oUses responses near the range of observation. 

•Includes a measure of variability in the response. 

•Determines a consistent measure of response. 

•Applies to fewer, more robust, toxicity data sets. 

•Accounts for more dose response of critical effect. 

Casarctt and Douli (Sixth Edition) page 94 

27172.200

Figure 2a. Multistage Model Fitted To Pooled Thyroid Tum

Showing S1nall Change In Slope Between Low & High D

0.35 r Tviultistnge Cancer 

B:.!D Lower Bouml 

0.3 

'V 0.25 2 

f.j 

/J 

'!: 0.2 < 

0 

.... 

'J 015 

e 

t.;.,.. 

0.1 

0.05 

0 

BMDL BMD 

0 0.5 1.5 2 2.5 3 

Dose (mg:/kg-day) 

Dow·son M.L., R. Hertzberg, B. Allen, L. Haber, A. Parker, 0. Kroner, A. Maier, and M. Kohrman, 20
206 


27172.201

.... --a :E s 

2 0 p_, iX1 

'-' "-' b: 

0 

>--1 

Cl 

..,.. 

"" iX1 

~ "' ~ N ~ a 0 0 0 d 

-~ 

0 

::e 

w 

0 

0 

"'' 

Ill 

ICl 

d 

~ 

:>-. 

~ 

"t:l I 

!::!/; 

..:4 

'bi., 

s 

'-' 

(\) 

Vl 

0 

Q 

27172.202

Table 5. Con1parison Of2o/o BMD, BMDL & Slope Factors 

For Acrylatnide's Thyroid TUinors In Rats 

r .I; a-s.< ___ Model BM Do2 SF l BM DL I SF BM D/BM D

BM Do2 IBMDLo2 

Multistage 0.39 0.052 0.23 0.087 1.7 

. p 0 led 

tumors 

Low-dose Mu ltistagc 0.80 0.025 0.23 0.088 3.5 

pooled I ~um or:;_ 

All Probit 0.81 0.025 0.69 0.029 1.2 

pooled 

tumors 

All W :ibull 0.82 0.024 0.72 0.028 1.1 

pooled 

tumors 

Low-d W eightcd 0.92 0.022 0.33 0.061 2.8 

pooled ncar 

tumors regress ion 

"' . . . c~ ~-- p 

multistage and pro bit mode Is with oll pooled tumors were eom para b le, howe vcr, 

BMD/ BMD L ratios (above) and visual fit differ (see Figure 2a.b). Bold printed row 

indicates model chosen for extrapolation to humans. 

27172.203

Conte1nporary: Categoric

Regression 

RtD Definition 

"without appreciable risk'' 

"is likely to be'' 

"deleterious effect" 

Regression model 

r < IQ-2 

P(*) > 0.95 

severity moderate or 

New RtD Definition 

P ( r < 1 o-2 at dose<RID) > 0.95 

where r = P (severity > 1) 

Hertzberg R.C. and \4.L. Dourson. 1993 

27172.204

Aldicarb Clinical Studies 

Frequency of Clinical Signs or Blood Cholinesterase 

Dose Blood 

Study (mg/kg- GroutJ Clinical Signs Cholinestera

Size 

day) Inhibition,

Haines, 1971 0.025 4 I Apprehension 4 Whole blood 

0.05 4 1 Runny nose" 4 Whole blood 

0.10 4 4 Weakness and svveating, 4 Whole blood 

Nausea in 2 individuals 

Wyld eta!., 0 22 0 0 Plasma & 0 R

1992b 0.010 8 2 Headachesc 0 Plasma & 0 R

0.025 12 1 Sweating 12 Plasma & 11 

RBC 

0.050 12 I Sweating I Plasma & I R

0.06 I I Sweating I Plasma & I R

0.075 " .) l Lightheadedness 3 Plasma & 3 R

Dow·son, M.L., L.K. Teuschtcr. P.R. Durkin and W.M. Stiteler. 1997 

27172.205

Effect Categories of Aldicarb Exposure i

Hutnans 

Frequency of Categories of Effect Associated with Aldicarb Exposure in Human

Frequency of Responders within 

Dose Group Categories of: Study (mg/kg/day) Size NO Non- Adverse Fra

Effects 

adverse Effects Eff

Elfects 

Wyld 0.0 22 22 (22) 0 (0) () (0) 0 

Wyld 0.010 8 8 (0) 0 (0) 0 (0) 0 

Wylcl 0.025 12 0 (0) 8 (11) 4 (1) 0 Wyld 0.025 4 0 (0) 0 (3) 4 (1) 0 Wyld 0.50 12 0 (0) 1 (11) 11 (1) 0 Wylcl 0.50 4 0 (0) 0 (4) 4 (0) 0 

Wyld 0.075 4 0 (0) 0 (2) 4 (2) 0 

Haines 0.10 4 0 (0) 0 (0) 2 (2) 2 

27172.206

Probability of Category with Aldic

-Pr(AE) 

0.8-1 -Pr(FE) 

[?0.6 

:0 

1f fl. 0.14 

0.2-. RID 

o I ~ I • ¥ ..... , -

0.0001 0.001 0.01 0.1 

Exposure (mglkg-d) 

0.81 

-Pr(AE) 

-Pr(FE) ~0.6 ~ £ 0.4 

0.2 .... R«) ~ 0 

0.0001 0.001 o:Ot 

E>:posum (mglkg-d) 

27172.207

Conte111porary: Categorical 

Regression 

• Advantages: 

- provides a consistent basis for calculating risk a

the RID 

- all useful data can be categorized - accounts for severity of toxic effect 

• Limitations: 

- animal to hun1an extrapolation is still needed 

- data are transfonned into categories which loses 

infonnation 

Patty's Toxicology, Volume I (Fifth Edition) pages :209-213 

27172.208

c . 

International Programme on Chemical Safety (IPCS). 2005. 

27172.209

... J 

Absorption 1 Absorption is complete. 

Distribution 1 Distribution occurs by 

passive diffusion. 

Metabolistn 1 No metabolism. 

Elimination 4 Clearance is 3 to 4 titnes 

faster in rats than human

Total kinetics 4 Interspecies differences 

(default is 4) kinetics were dominated 

elimination. 

Dynamics 2.5 Default of 2.5 was retain

(default is 2.5) 

Interspecies 10 Factor to be applied. 

Dourson, M.L., A. Maier, B. Meek, A. Renwick, E. Ohanian and K. Poiriec !998. 

27172.210

Absorption 1 As above 

Distribution 1 As above Metabolism 1 As above 

Elitnination dominated by 

the glomerular filtration r

Elimination 1.8 a 1.8 fold variation betwe

the average pregnant wom

and two standard deviatio

below that. 

Total kinetics See note under eliminatio

(default is 1.8 above. 3.2) 

Dynamics 

(default is 3.2 Default of 3.2 was retaine

3.2) 

.. 5.7 Factor to be applied. 

27172.211

TERA 

Toxicology Excellence 

for Risk Assessment 

::! ;!:i!:'j:!::'i'::s!:imm 

CSAF = AKAF X ADAF X HKAF X HD AF 

4 X 2.5 X J.8 X 3.2 

57 (rounded to 60) 

EPA IRIS (2009) uncertainty factor is 

3.3 X 3.16 X 2 X 3.16 

66 

27172.212

TERA 

Toxicology Excellence 

for Risk Assessment "' It is now routine to ask folks whether or not a 

PBPK model is available for the chemical of 

interest. 

" Numerous PBPK papers; some have been given 

top awards (RASS of SOT papers of the year): 

- Sweeney, L. et al. (200 1 ). Proposed occupational 

exposure limits for select glycol ethers using PBPK 

models and Monte Carlo simulation. Toxicol. Sci. 

62(1 ): 124-139. 

- Kinnan, C.R., et aL (2004). Addressing nonlinearity 

the exposure-response relationship for a genotoxic 

carcinogen: cancer potency estimates for ethylene 

oxide. Risk Anal. 24:1165-1183. 

27172.213

!iiu.I•Hiii!;•!' ij! 

lifn•ir 

Create : 

Collaborate/Research 

.. Risk Information Exchange (RiskiE) 

" International Toxicity Estimates for Risk (ITER

.. Alliance for Risk Assessment (ARA) 

.. CRADAs, testing of mutational MOA with NC.. Genomics .. NAS (2008) 

.. Peer review 

27172.214

" 1 

www.allianceforrisk.org/RiskiE.htm 

"' An interactive Database to 

Communicate In-Progress 

Risk & Toxicity Assessmen

., Includes over 7000 project

being conducted by more th

27 organizations representi

13 countries 

<!; Available at the Alliance fo

Risk Assessment (ARA) 

website 

27172.215

International Toxicity Estimates for A-1!11\;; 

www.tera.org/ITER 

http:/ /toxnet.nlm.nih.gov 

' '- ' > ,' c '-- ' ' 

Provides chronic human health risk values andj~~ij¢er 

classifications from organizations around the wof:lg:for 

over 650 chemicals , 

Includes a synopsis that explains the underlyin~! basis 

and rationale for each risk value and differences in risk 

values 

• A link to each organization's website or source document 

forum through which independent parties can share 

peer reviewed risk values 

27172.216

States, f\ 

Fed. Agencies, 

Public Interests, 

Industry 

Public 

Risk Infonnation 

Exchange (RiskiE) 

27172.217

Science and Formulation to Resp

Science and Decisions 

27172.218

"" X 0) <I) $ X 0) 

0 0) 

<0 ?: 

m 0 0 

<0 

..... 

t ro 0 

.... ~ X (/!. 

-

--

(;' ~ c: c: 

0) $ 

::I :'Q 

0' 0 

\!! £ 

u. '-

c ~ ro c: 

:; ro u ~ .. • Case study 2: Dose-Response Analysis for Dichloroacetic Acid 100 -.-- • ,..,....- / / 80 / ~ .,/ / 60 / ~ • Obsf?rved mutant freque-ncy "Y Predicted mutant fteq1.J.ency • Obs.erved cancer itH:::1denee --- Predicted .canc-e-r incidence 20 0 0.0 0.5 1.0 1.5 20 2.5 3.0 3.5 

Dose (mg/ml) 

. 

--. 

I

I 

1

1

40 

27172.219

. As s 

Bowyer eta!., 2008. Subchronic acrylamide exposure in Fischer 344 rats. 

Expression levels 

%Relative Relative to 

Region Gene Expressed to Contro13 GAD PH 

Thyroid Glyceraldehydephosphate 83±12% NA 

dehydrogenase (GAPDH) 

Thyroid Thyroglobulin 102±18% 54.6-fold 

Thyroid Thyroid peroxidase 102±18% 0.278-fold 

Thyroid Sodium iodide symporter ir142±22% 0.0218-fold 

Thyroid Type I 5'-deiodinase 142±38% 0.295-fold 

Thyroid Type II 5'-deiodinase 189±33% ' 0.0181-fold 

Thyroid Type Ill 5'-deiodinase 113±18% 0.00139-

foldb 

Thyroid Mki67 109±14% 0.0619-fold 

Pituitary Thyroid stimulating 108% 12.31 hormone~ Pituitary Thyroid hormone 103% 8.53 

receptor a 

Pituitary Thyroid hormone 109% 8.74 receptor~ P valued NA 0.97 0.77 0.12 0.48 0.034 I 0.53 0.71 0.30 0.57 0.73 

--

Statist

signif

~-~ 

27172.220 Tm::~[~:mii:m:m:'r- ~;::~:r.mim:n:m:;::'"' ~~r~' I~;I!;N~~; ·.~~;!Ht=l!!;iNriitt.te!irt!'l s . : Advancing Assesstnent (NAS 2009

.. Gave suggestions on hiring, training and plannin

.. Suggests incorporation of background exposure

stressors, and/or diseases in modeling efforts .. Suggests common dose response approach for a

endpoints; default is a no threshold model .. These latter two suggestions are controversial 

- Background exposures and diseases are included in 

control groups 

- Including background exposures/stressors obviates tie

the "Component" part of EPA mixtures guidelines 

- Ignoring thresholds is not consistent with most toxicol

.. Several current methods were overlooked 

27172.221

"' Cornerstone principles 

';r Scientific robustness 

'r Selection of appropriate panel expertise 

';r Transparency 

)... Independence 

e Distinguish conflict-of-interest from bias 

/rAvoid COl 

'r Balance biases 

,. Rule of thirds; 1/3 of the panel should be 

'r Experience risk assessors 

'r Chemical or related-chemical experts 

? Effect experts 

• Balanced affiliations 

27172.222

;:! 

Summary 

• Know traditional risk methods cold 

- Involve clinicians 

Challenge non-experts 

"' pora 

Categorical Regression, CSAF, PBPK 

.. Create future by Ia and resea 

Hang together, or hang separately 

Focus on collaboration among agencies 
228 


27172.223

V') 

(].) 

"'0 

V') 

ro 

!.... 

+-J 

X 

w 

• 

27172.224

Thresholds 

Wikipedia: Point where one mentally or physically 

vulnerable in response to provocation or to 

particular things in general, as in emotions, stre

or pam. 

Word software: Level at which effect starts 

The question is not whether a chemical has a thres

for an adverse effect---since all chemicals do---

rather can it be that this threshold is one molecu

37 

27172.225

Whole Mixture Exposure Assessment 

Hazard 

Quotient; 

Risk Estimate 

i 

• 

Epidemiological 

Evaluations, 

Toxicity Profiles 

Available 

Interactions 

Data 

Interaction-Based 

Hazard Index, 

Interaction Profiles, 

Weight of Evidence, 

PBPKModels 

Relative 

Potency 

Factors 

Component 

Data Available 

l 

Integrated 

Additivity 

Methods 

Component Exposure Assessment 

l 

Index Chemical-Based 

Risk Estimate; 

Hazard Quotient 

Toxicol

Indep

Comp

27172.226

efining the range of the reference dose: 

imprecision versus uncertainty. Dourson ML ;(, 

Gadagbui B, Pfau E, Thompson R, Lowe) 

*Alliance for Risk Assessment (ARA); 

Toxicology Excellence for Risk Assessment; 

Hull & Associates, Inc.; Alliance for Site 

Closures; CH2M-Hill 

27172.227

Hazard Range and 

robl m ormulation 

The development of a hazard range 

should help to address the following 

problems: 

o Hazardous waste site remedial objectives for 

chronic exposures 

Communicating risk/hazard of exposure 

above RfC 

Prompt/short term exposure action levels 

Inform the confounding effects of assessing 

ambient background concentrations in air 

27172.228

TC Residential Indoor Air 

Acceptabl xposure Levels 

Based on CaiEPA values (2000) 

HQ = 1: 630 ~9Im 3 ELCR = 1 x 10-6 : 1 .2 !191m3 

ELCR = 1 x 10-5 : 12 !191m3 

ELCR = 1 x 10-4 : 120 !191m3 

Based on US EPA IRIS (October 2011) 

1 ' , 1 na 

ELCR = 1 x 1 0-6 : 0.48 ~91m3 

ELCR = l x 10-5 : 4.8 ~9/m 3 ® ELCR = 1 x 10-4 : 48 ~-t9/m 3 

27172.229

Risk A se sment a d Risk 

Management 

Excess Lifetime Cancer Risk (ELCR) 

Range: 1 o-6 to 1 Q-4 

Provides risk managers flexibility to balance 

acceptable exposure levels with closure nee

Technical feasibility 

• lmplementability 

· Timeliness 

• Economic considerations 

• Cultural or other concerns 

How may a similar evaluation be 

performed with respect to the noncancer endpoint? 

27172.230

P ble Response: Alliance for Risk 

Assessment (ARA) 

ARA TCE Workgroup formed in the Fall 

2012 

Open invitation, broad interest and 

participation 

Trichloroethylene (TCE) Risk Assessment 

Guidance for Contaminated Sites (April 2013

Webcast: Practical Guidance for Contaminate

Sites: TCE Risk Assessment Case Study 

(November 4, 2013) 

Observers: over 300 scientists from multiple 

international organizations, including 

government, industry, academia and NGOs, 

6 conference calls and one webinar. 

27172.231

NAS (2014) I I Process 

"Finding: EPA could improve documentation 

and presentation of dose-response informatio

Recommendation: EPA should clearly present 

two dose-response estimates: a central estim

(such as a maximum likelihood estimate or a 

posterior mean) and a lower-bound estimate 

a POD from which a toxicity value is derived. 

The lower bound becomes an upper bound fo

cancer slope factor but remains a lower bound 

for a reference value." [emphasis added] 

27172.232

N (201 ) IRI rocess ~~> "Finding: IRIS-specific guidelines for consistent, 

coherent, and transparent assessment and 

communication of uncertainty remain incompletely 

developed. The inconsistent treatment of uncertainties 

remains a source of confusion and causes difficulty in 

characterizing and communicating uncertainty. 

Recommendation: Uncertainty analysis should be 

conducted systematically and coherently in IRIS 

assessments. To that end, EPA should develop IRISspecific guidelines to frame uncertainty analysis and 

uncertainty communication. Moreover, uncertainty 

analysis should become an integral component of the 

IRIS process." 

27172.233

ference ose (IRIS) 

"The RfD (expressed in units of mg of substance/kg 

body weight-day) is defined as an estimate (with 

uncertainty spanning perhaps an order of 

magnitude) of a daily exposure to the human populatio

(including sensitive subgroups) that is likely to be withou

an appreciable risk of deleterious effects during a 

lifetime." [emphasis added] 

That is, the RfC/RfD is expected to be below the actual 

threshold for adverse effect in a sensitive subgroup. 

27172.234

Unc rtainty vs. Imprecision 

Alternative interpretations: 

Imprecision of a RfC is on both sides of the RfC. T

is because a 2nd expert group might estimate a R

higher or lower than the 1st group, if given the sa

information. 

Uncertainty in a RfC, in contrast, lies mainly above 

the RfC. This is because RfCs are based on lower 

bounds on PODs and UFs are known to be protecti

For risk management decisions, uncertainty in the 

RfC is generally more important than imprecision. 

Managers are interested in making decisions that 

protect public health and uncertainties in a RfC are 

generally more informative. 

27172.235

a ard Range vel pment 

Hazard Range 

Floor 

Intermediate value (Midpoint) 

Ceiling 

27172.236

Fl ofth azard ange 

Identified as the RfC/RfD based on a 

single candidate value 

In the case of an RfC/RfD based on two 

or more candidate values 

identified as the candidate RfC/RfD with 

the higher(est) confidence. 

The reference value is not likely to change with 

further testing, except for mechanistic studies th

might affect the interpretation of prior test resul

RfC could be modified if refined data are obtaine

to modify uncertainty factors -e.g., kinetic data 

for chemical-specific adjustment factors. 

27172.237

Flo r o he Ha ard Range 

The RfC/RfD is developed: 

o using UFs that are protective based on the 

observed behaviors of a typical toxicant 

so that the RfC/RfD is an underestimate of the 

expected threshold value. 

o The floor of the hazard range may be denoted 

as a point below which risk managers are 

unlikely to recommend remedial action or 

exposure control. 

27172.238

Ceili g of the Ha ard Range 

Is defined as the adjusted point of 

departure (PODadj) 

POD based on the critical 

concentration/dose of chosen study. 

Managers likely to take regulatory action 

above this ceiling since specific toxic 

effects can sometimes be seen. 

27172.239

il i ng: djust d PO 

Adjustments for the dosing regime in the 

critical study, such as ... 

Toxicokinetic differences between the test 

organism and humans 

Database quality, lack of NOAEL, and study 

duration; reductions are based on available 

data, or a factor of 3 used as a default for each 

area. 

The intent of these adjustments and reductions 

is to estimate the likely ceiling of the RfD /C by 

using the median value of the Ufs. 

27172.240

Midpoint f the a ard Range 

Unlikely to be associated with adverse 

effects in a human population, based on ... 

Greater understanding of the range of uncertaint

associated with RfC/RfD development and 

o Consistent with the definition of "uncertainty of u

to an order of magnitude" impacts the RfC/RfD 

It is a plausible estimate of the upper 

concentration or dose that is likely to be 

protective of the general population, 

including sensitive subpopulations 

27172.241

Midpoin th a a Rang ~ Is a judgment that meshes four 

considerations: 

Collective magnitude of the UFs 

Steepness of the hazard slope describing 

exposures above the RfC/ RfD 

The confidence in the selection of the critical 

effect 

The confidence in the POD 

27172.242

Johnson tal., 003 

== g m3 

Fetal malformation endpoint 

o Intermediate value of 1 0 1J9/m3 is judged to be 5-

fold above the candidate RfC due to: 

Its small UF of 1 0, 

Shallower hazard slope, 

Low confidence in the critical effect, and 

Low confidence in the choice of a benchmark response 

of 1% (BMDL01 ) 

27172.243

0.05 

R 

e 0.04 

s O.DJ 

? 

0.01 

D 

n 

s 

Hazard Ranges of Two 

Candidate RfCs for TCE (as 

per Gentry et al.) 

Figure 2. Hazard Range of Heart 

Malformations POD= BMD 

BMD ri1k up !o 

0.011 

- Uneo: (BMD risk tip to) 

0 0005 0.01 0 01) 0.02 

CDntentntion ppm 

0.05 

R 

e 0.04 

s 0.03 

p 

0 0.02 

figure 4. Hazard Range of 

Nephropathy POD=BMD 

0.020 

BMD risk up to 

-linear (BMD ri1k up to

0 0.005 0.01 0.015 O.G2 

Concentration ppm 

27172.244

T, 19 

RfC == 3 JJ 3 

Toxic nephropathy endpoint 

Intermediate value of 9 ~g/m 3 is judged to be 3-

fold above the candidate RfC due to: 

Its small UF of 1 0, 

Steeper hazard slope, 

Medium confidence in the critical effect, and 

Medium to low confidence in the choice of a 

benchmark response of 5% (BMDL05 ) 

27172.245

Keil t al., 2009 

RfC = 2 1J jm3 

Decreased thymus weight endpoint 

Intermediate value of 20 ~g/m 3 is judged to be 10-

fold above the candidate RfC due to: 

Its larger UF of l 00, 

The effect shown by Keil et al. (2009) does not lend 

itself to dose-response modeling, so steepness of the 

slope was not assessed 

Medium confidence in the critical effect, and 

Medium to low confidence in its choice of a LOAEL as 

the POD 

27172.246

T as an xampl 

Table 7, Different uncertainty ranges for different ICE RfCs, All values are in ~tglmJ Shaded areas 

indtcate best on ran uncertaintY l'iutl!:e for risk management purposes. 

Endpoint Confidence Uncertainty Ranges 

Study IRIS Steep" Critical' Pointofa Floor Intermediate 

t.r' Slope Effect Departure 

Joimson et al Fetal Lower LO\V Low 2 10 

(2003) malformation 10 

I 

ToxiC 

nephropathy Higher Medium Medimn NIP 3 9 (1988) 10 to Low 

Decreased 

thymus NA Medium Medium Keil et aL 2009 2 20 we1ght 100 to Low 

a, Size of the uncertainty factor as on IRIS 

b. Steepness of the hazard ;,lope (i.;L the slope of the line describing hypothetical population responses at 

concentrations above the Ril:} as per Section 3. 

c. Confidence in the choices of critical effect as per Section 4. 

d. Confidence in the POD. as per Sectiou4. 

Ceiling 

20 

30 

60 

27172.247

Practical Application of the 

Ha ard Range for TC 

ES Figure la. Exposure dtstribuhon of mdoor air couceutrattom 

pruuanly below the 3 pg!m'to 20 }tgim3 haza;·d range. Relatively sn1.1ll 

proportton of exposures is higher tl1.1n 3 1•g·m' Nominal actions or no 

fut1her action may be wananted for risk management 

ES Figure lb. Exposure !hs!!:butwn of indoor arr concentraltons faHmg 

mthiu the 3 pglm' to 20 flgim' hazard range Relatively ;mall propor1ion 

of exposures is lugller ihan9 flgm' Lmuted action may be wananted for 

risk llk'lllagement 

dtstnbu!!on of mdoor a1r concentratw!JS pnnl.1rliy 

· llazard rang~?. Actions to reduce exposm·e; 

27172.248

For more 

information 

GQidance for Contaminated Sites: Tnchloro;thylene Case.Study. Gadagbui~ et al., SOT, 53r Annual Meetln_g & ToxExpo, 2.J-27 March 2014, Phoenix, A£. 

Development of a Non-cancer Hazard Range for Etfective Risk Assessment and Risk MC\nags;men

of Contaminated Stfes: A Case Study wtth 1'CE and Other Chemica s Beyond Science & Decisions: Problem Formulation to DoseResponse Assessment Workshop VIII, 21-22 May 2014, Austin, T A. 
254 


27172.249

-· :J 

0 

>-

~ 

c 

rtS 

.c 

I-

27172.250

C iteria: rough the Years 

Withdrawn US EPA IRIS ( 1 989) 

Inhalation Unit Risk= 1.7 x 1 o-6 (!J.gfm3)- 1 

CaiEPA values (2000) 

Chronic inhalation REL = 600 !J.9/m3 

Inhalation Unit Risk = 2 x 1 o-6 

Draft US EPA TCE Assessment (2001) 

Prov. RfC = 0.04 mg/m3 = 40 !J.9/m3 

Prov.lnhalation Unit Risk= 5.7 x l0- 6 

(!J.9 I m3)-1 

to 1.1 x 1 o-4 (!J.g/m3)-l 

US EPA IRIS (October 201 1) 

RfC = 0.002 mg/m3 = 2 !J.9/m3 

Inhalation Unit Risk = 4.1 x 1 o-6 (!J.g/m3)-l 

27172.251

ons quences of the New TCE 

Toxicity Values (Problem 

F rmulation) 

Risk-based indoor air levels now based upo

non-cancer endpoint (RfC) 

The RfC is based on both chronic and 

developmental endpoints 

Prompt/ short term exposure action levels based on the RfC 

Prompt action exposure concentrations 

Application of lifetime RfC to acute and subchron

exposures 

Confounding effects of assessing ambient background concentrations of TCE in air 

27172.252

NAS Scien and Decisionss· 

Advancing Risk Assessment 

( 9) 

"For noncancer end points, it is assumed that 

homeostatic and defense mechanisms lead to a 

dose threshold (that is, there is low-dose nonlinearity), below which effects do not occur 

are extremely unlikely. For these agents, risk 

assessments have focused on defining the reference dose (RfD) or reference concentration (RfC), a putative quantity that is 'likely to be without an appreciable risk of deleterious effect

(EPA 2002a, p. 4-4)." [emphasis added] 

That is, the RfC/RfD is expected to be below thi

actual threshold for adverse effect. 

27172.253

NAS Science and Decisions: Advancing Risk 

Assessment (2009) 

"The "hazard quotient" (the ratio of the environmental 

exposure to the RfD or RfC) and the "hazard index" (HI} ... An 

less than unity is generally understood as being indicative of 

lack of appreciable risk, and a value over unity indicates som

increased risk. 

The larger the HI, the greater the risk, but the index is not 

related to the likelihood of adverse effect except in 

qualitative terms: 'the HI cannot be translated to a 

probability that adverse effects will occur, and is not likely 

be proportional to risk' (EPA 2006a)." [emphasis added] 

27172.254

N (2009) Hazard 

ss ssment 

NAS (2009): 

Suggested that methods for assessing 

non-cancer toxicitY. have the capability of determining hazaro ranges. ARA project HBeyond Science and Decisions: From Problem Formulation 

to Dose Response" Built on NAS (2009) report Six of its cases studies are about 

evaluating noncancer risk (at different doses) 

Each was vetted by a Science Panel 

We focus on: 

modeling risk above the RfC/RfD using th

benchmark dose method (Gentry et ar:, 11 ). 

27172.255

P bl m Response: Alliance for Risk 

Asse sment (ARA) 

Guidance for Contaminated Sites: 

Trichloroethylene Case Study. GadagbuL eta/., SO""G 53rd Annual Meet1ng <SL ToxEXl)o, L3-27 March 2014, Pfloenix, AZ. 

DeveloP,.ment of a Non-cancer Hazard Range for Effective Risk Assessment ancrRisk Mana_gement of Contaminate

Sites: A Case Study with TCE and Othe

Chemicals, Beyond Science & Decisions

Problem Formulation to Dose-Respons

Assessment, Workshop VIII, 21-22 Ma

2014, Austin, TX. 

27172.256

Yes, "Thresholdable" Carcinoge

are Still Delaney Carcinogens 

Michael Dourson, PhD, DABT, ATS 

TERA Center 

University of Cincinnati 

27172.257

Life is Chemistry ... 

• We are all exposed to a sea of chen1icals daily. 

Coffee vvith -1000 chen1icals; 20 to 30 of then1 knovvn to be e

tnutagenic or carcinonenic .._. b 

No pure \Vater anyvvhere 

Acrylmnide, a known carcinogen, in --40o/o of our cooked food 

Pharn1aceuticals in our vvatenvays 

Mixtures of diverse che1nicals jn our air due to just living in a ~ .._ 

house, vvorking in a city, or playing soccer on artificial turf 

Soils are a con1plex 111 ixtures of living and dying organisn1s ea

\Vith its O\Vl1 ste\v of chen1jstries ... 

27172.258

Adding to this Complexity a

Four Things to Remember 

• Dose matters • Timing is critical 

• People differ 

• Things change 

[Hayes, Kruger, and Clemens, 2016] 

27172.259

Fortunately ... 

• These 1000+ chemicals each have a safe or virtually safe d

- For noncancer toxicity this can be an ADI, RfD, MRL, TDI, DNEL, OE

TLV, PEL, REL, etc. .. based on a NOAEL, LOAEL, BMD, or HED, HEC w

associated SF, UF, CSAF, DDEF, or AF, etc. 

- For cancer toxicity this can be a VSD or RSD, with associated Cis, b

on a POD, SF, or Ql *, etc. 

• These doses can be use with exposure assumptions to 

determine for either cancer or noncancer toxicity a ... 

- MRL, HQ, MOE, MOS, HI, DWEL, etc. .. 

• Fortunately ... ? 

27172.260

So What of All This Science? 

• The overriding goal of federal policies governing the use 

of chemicals is- and should be- consumer safety. 

• Fess up. Doesn't your family only want to know at dinner 

whether the chemical highlighted in the daily news is safe? 

• And isn't this question asked everywhere else in the count

• And somehow do you think that US Congress is any differe

• Au contrairel And this is why the Delaney amendment wa

passed. Science is complex and safety is paramount. 

27172.261

So ... Is It safe? 

• For some toxicities the answer is easy ... For example, one 

chemical is: 

- A well known flame retardant 

- An established neurotoxin 

- An endocrine disrupter for sure ... 

• And a macronutrient ... a Reference Dose (RfD) is appropr

• But for other toxicities like cancer ... 

27172.262

US has 7th-highest-cancer-rate-in-world 

• Jan 24, 2011 --About 300 of every 100,000 Americans 

develop cancer each year, earning us 7th place! 

- The new ran kings were compiled using World Health Organization 

{WHO) estimates. 

• We are higher than we should be, and it's not the type of l

on which you want to be on top, says Alice Bender, MS, RD

- Due to lifestyle? Americans are more likely overweight from eating 

much food, drinking to much alcohol and being less active. 

• So has the "war on cancer" reduced our rates? 

27172.263

And What About 

Idiopathic disease? 

one that exists 

without any 

connection with any 

known cause. 

[http:/ /medicaldictionary.thefreedictionary.com/idio 

pathic+disease] 

Idiopathic Diseases (partial listing): 

• Alabama rot 

• Condylar resorption 

• Diffuse idiopathic skeletal hyperostosis 

• Idiopathic giant-cell myocarditis 

• Idiopathic infantile arterial calcification 

• Inflammatory demyelinating diseases o

central nervous system 

• Idiopathic interstitial pneumonia 

• Idiopathic pulmonary fibrosis 

• Immune thrombocytopenic purpura 

• Juvenile idiopathic arthritis 

• Multifocal fibrosclerosis 

• Pellucid marginal degeneration 

• Systemic-onset juvenile idiopathic arthr

[https:/ I en.wikipedia .org/wiki/Category:ldiopathic_ diseases

27172.264

Or Evaluating Chemical Mixtures? 

Mixture 

RfD/RfC; 

Slope1Factor 

1 

Health 

Evaluations 

l 

Whole Mixture Exposure Assessment 

Hazard 

Quotient; 

Risk Estimate 

+ 

Epidemiological 

Evaluations, 

Toxicity Profiles 

EPA, various references 

I 

oxicologically 

Similar 

& Independent 

' I :Dose ~ddifion : I'" I 

t • ,,~ i 

Available I Relative 

// 

Integrated 

Interactions ! Potency Additivity 

J. l l ~ Component Exposure Assessment ~ J i 

Interaction-Based Hazard Index Chemical-Based 

Index, Interaction, Index Risk Estimate; 

Weight of Evidence, Hazard Quotient 

PBPK Models 

l 

Resp

A d

i 

R

Est

27172.265

Legislative Answer? Chemicals are not Sa

Unless Proven Otherwise 

• Repeal Delaney? One needs to find a legislative replaceme

- Perhaps an 95% upper-bound, one in a million, lifetime, excess, can

risk, where the risk is unlikely greater, but likely lower and perhaps 

• Delaney prevents beneficial product development? 

- A simple walk around the grocery store readily disputes this claim. 

• But opposition to Delaney may be based on misunderstand

- Allows discretion if substance induces cancer when ingested in test

ich are appropriate. Expert judgment needed here. 

- Once "induced" limit of science is reached. Delany assures safety. 

27172.266

To the Rescue I 

• The Society of Toxicology (SOT) mission is to create a safer 

healthier world by advancing the science of toxicology and 

increasing the impact on society from these advances. 

• Specialty Sections are formed to help with understanding 

assessment and regulatory and safety evaluation. 

• Better communication to the public and Congress is neede

27172.267

Health Risk Assessment for 

: New Direction in 

EPA's Modeling Approach for 

Establishing Standards 

Michael Dourson, Ph.D., FATS, FSRA 

John Reichard, PhD, PhannD 

University of Cincinnati, College of Medicine 

27172.268 ~ EPA's Science Advisory Board (SAB, 2013) recmnmended crafting a 1nodel on perchlorate's effects on sensitive lifestages to assist the agency in determining an appropriate maxitnum contaminant level goal (MCLG). In an effort to fulfill the recommendations of this panel, EPA (20 16) showcased a model, which is the first step in a two step process to develop an MCLG. EPA choose hypothyroxinemia as the critical effect, that is the first adverse effect or its known precursor, as part of this modeling effort. 

27172.269

The peer reviewers identified a nmnber of areas for 

i1nprovement of the proffered model: 

• 

I 

Develop a plan for further actions in order to maximize the benefit of 

any model revisions. 

Develop a model that is fit for the intended purpose. Specifically, how 

the model outputs would be used in developing the MCLG. 

° Changes in hormones are precursors of the critical effect that 

leads to neurotoxicity. Models should facilitate: 

Linkages between perchlorate exposure and iodine handling and 

impacts on thyroid hom1one levels, and 

Relationships between thyroid hormone status and neurodevelopment 

in critical fetal, especially 1st trimester, and post-natal periods. 

27172.270

I 

., EPA should establish an interaction with clinicians and 

epidemiologists with expertise in thyroid function and 

neurodevelop1nent. 

EPA should clearly convey the scope of the modeling effort, 

the biology the 1nodel addresses, and the model applications . 

., EPA needs to clearly state why the current n1odel, which likely 

could always be improved given additional time and resources

represents a fit-for-purpose solution applicable to current 

efforts to develop regulatory standards for perchlorate. 

27172.271

'" The physiologically-based pharmacokinetic/pharn1acodynamic 

(PBPK/PD) model of EPA accounts for differences in exposure 

and biology across life stages, and is a good start at 

understanding iodine nutrition and perchlorate exposures. 

However, EPA needs to explain thyroid changes as critical 

effects, in contrast to NAS (2005) and its own definition. 

" EPA also needs to support its assumption of 2.5111 to 1Oth 

percentile of ff4 as a hypothyroxinemia range, and incorporate 

sytnporter up-regulation in the model. 

University of Cincinnati, College of Medicine, November 23, 2016 

27172.272

Nonadverse 

Effect 

lnhlb/Uon of 

lodld• 

upt.hln 

thyroid 

NAS, 2005. Health implications of 

perchlorate ingestion 

! Serum 

.I T3, T4 

------., ! 

t Serum TSH 

First 

Adverse 

Effect 

adverse 

effect or it

Thyroid I \ l hypertrophy IE known [an

imrnediate

precursor 

or 

hyperplasia 

' 

t ' 

Hypothyroidism 

\ 

\ 

\ 

\ 

\ 

\ 

Abnormal "fetal 

and chUd 

grow1h and 

development 

, (EPA, 2017

I IRIS 

l_9lossary). 

FIGURE S.l Committee's suggested mode-of-action model for perchlorate in humans 

indicating first adverse effect in the continuum. 

27172.273

EPA could select as the critical effect a lower 2.Sth percentile 

of free T4 in the chosen sensitive population. 

(I Although not technically the critical effect, this percentile may 

be a reasonable surrogate for increase in TSH, which would be 

necessary for thyroid hyperplasia and hypertrophy, which are 

the known precursors to the first adverse effect frmn 

perchlorate, and therefore the critical effect (NAS, 2005, page 

111 ). 

University of Cincinnati, College of Medicine, November 23, 2016 

27172.274

page 75 

Effect of 

Perchlorate on 

Hormones 

the Infant, Breast 

and Fetus Model 

25 20 

Q. 

........... 

ll:f 15 

..... 

....... 

E 

:J 10 

1.. 

Q) 

m 

5 

Breast-fed, 

day 7 infant 

Maternal iodine intake 

- 75 IJQ/d -- 100 1-IQ/d 

.•.. 150 IJQ/d - 200 IJQ/d 

- 250 pg/d 

. 

Ot....---......t----.............1....1....._ ___ ---l 

0 4 8 12 16 20 

Perchlorate dose (pg/kg I d) 

27172.275

"' If EPA selects an iodine-deficient subpopulation as the basis 

for its MCLG, then this choice reduces the need for an 

uncertainty factor for within human variability. 

®! EPA should consider observations from prospective 

epidemiology studies, specifically Tellez et al. (2005) for 

applicability to the US, consistent with NAS (2005, page 69). 

EPA should consider how the model1night be modified by upregulation of symporter expression in the perchlorate dose 

range of interest, or if not possible, then un-n1odeled upregulation leads to a more conservative or MCLG. 

27172.276

Chanaral /5 Antofagasta 

100% 

90% 

80% 

-

c 70% 

u 

.. 60% 

c.. 

> 50% 

:;::: 

ltl 

:; 40% 

E 

:I 

0 30% 

20% 

10% 

0% 

0.1 10 100 

Urinary Perchlorate, J•g/g creatinine 

Tellez et al., 2005. Long-Term Environmental Exposure to Perchlorate Through 

Drinking Water and Thyroid Function During Pregnancy and the Neonatal Period 

'fi!l \!';:}ii:J:U:'i'';: ii ;':!,, 9, :;r;{iU•.:'i, 

1000 

27172.277

MATERNAL PERCHLORATE EXPOSURE DURING PREGNANCY 

2.00 

N=112 

1.75 

., 

1.50 g; eo: efi 6 <> 

....J I Drai 

us I c: 

Ol ' z <1> 

!: I 0: 

<> 

···oou-e·-.. oa.o o 

<> o f:'ll"l o o·r.l·o-··1:'1. · ··········"· n 

..; 1.00 C: o o···o·"o-cro 

1-

Ill 

0.75 

····l"l·ii'il·· E'li"l·6f'!.GGOOO·· 80 6. 

··f'!.4)L.CUJ1;\i1l"'OG <;>Dl"t/\!).!).!1!).1'J00V'l008 

o······· CI'JDO 0 

[) --·no 

0.50 

0.25 

Free T4 = 1.919-0.399 x Maternal Age- 0.00800 x Weeks Gestation 

0.00 

0 4 8 12 16 20 24 28 32 36 

Weeks Gestation 

Tellez et al., 2005. Long-Term l:nvironmental Exposure to Perchlorate Through 

Drinking Water and Thyroid Function During Pregnancy and the Neonatal Period 

40 

27172.278

From a clinical perspective lactation is associated with iodine 

uptake in the breast, and, there is a well-documented clinical 

increase in thyroid hormone requirements during pregnancy. 

& However, colleagues of the University of Cincinnati are 

unaware of any clinically increased rate of hypothyroidism in 

breast-feeding women cmnpared to those choosing to feed 

their children formula. Thus, pregnancy and its increased 

thyroid hormone requiren1ents appear to have a far greater 

impact on the mother than breast-feeding. 

EPA should explore the clinical relevance of the breast-feeding 

maternal population prior to choosing it for any point of 

departure in developing an MCLG. 

27172.279

0 EPA's biologically based dose response model addresses n1any 

of the challenges the Agency has faced in establishing 

causality and uncertainty with perchlorate exposure. 

0 peer review panel highlights important limitations in the 

model that impact its viability in developing of an MCLG, the 

most important perhaps is whether the "critical effect" should 

be multiple steps before any adverse effect, and whether a 1st 

trimester fetus is more sensitive. A second peer review is 

planned for later this summer. 

However, EPA has a good basis for the sensitive population; 

thus, the need for uncertainty factor for within hun1an 

variability is lessened. 
285 


27172.280

-

27172.281

Practical Guidance on a Non-cancer Hazar

Range for Effective Risk Management of 

Contaminated Sites: A Case Study with 

Trichloroethylene and other Chemicals 

Tri-Service Environmental 

Risk Assessment Work Group 

january 2 I , 20 I 5 

Pfau EJ*, Thompson R, Gadagbui BK, Gillay D, Lowe j, Dourson 

*Huff & Associates, Inc.; Alliance for Site Cfosures;TERA; Barnes 

Thornburg, LLP; CH2M-Hill; Alliance for Risk Assessment 

27172.282

NAS (2009) & Hazard Assessmen

NAS (2009): 

o Suggested that methods for assessing non-cancer 

toxicity have the capability of determining hazard 

ranges. 

ARA project "Beyond Science and Decisions: 

From Problem Formulation to Dose 

Response" 

o Built on NAS (2009) report 

o Six of its cases studies are about evaluating 

noncancer risk (at different doses) 

Each was vetted by a Science Panel 

We focus on: 

o modeling risk above the RfC/RfD using the 

benchmark dose method (Gentry eta/., 20 II). 

27172.283

NAS (20 14) & IRIS Process 

iii "Finding: EPA could improve documentation and 

presentation of dose-response information. 

Recommendation: EPA should clearly present two 

dose-response estimates: a central estimate (such as a 

maximum likelihood estimate or a posterior mean) and a lower-bound estimate for a POD from 

which a toxicity value is derived. The lower bound 

becomes an upper bound for a cancer slope factor but 

remains a lower bound for a reference value." 

[emphasis added] 

27172.284

NAS (20 14) & IRIS Process 

"Finding: IRIS-specific guidelines for consistent, coheren

and transparent assessment and communication of 

uncertainty remain incompletely developed. The 

inconsistent treatment of uncertainties remains a source 

of confusion and causes difficulty in characterizing and 

communicating uncertainty. 

Recommendation: Uncertainty analysis should be 

conducted systematically and coherently in IRIS 

assessments. To that end, EPA should develop IRIS-specifi

guidelines to frame uncertainty analysis and 

uncertainty communication. Moreover, uncertainty 

analysis should become an integral component of the 

IRIS process:· 

27172.285

Reference Dose (IRIS) 

"The RfD (expressed in units of mg of 

substance/kg body weight-day) is defined as 

an estimate (with uncertainty spanning perhaps an order of magnitude) of a 

daily exposure to the human population 

(including sensitive subgroups) that is likely 

to be without an appreciable risk of 

deleterious effects during a lifetime." 

[emphasis added] 

That is, the RfC/RfD is expected to be belo

the actual threshold for adverse effect in a 

sensitive subgroup. 

27172.286

Uncertainty vs.lmprecision 

Alternative interpretations: 

Imprecision of a RfC is on both sides of the RfC. This i

because a 2nd expert group might estimate a RfC 

higher or lower than the I st group, if given the same 

information. 

Uncertainty in a RfC, in contrast, lies mainly above the 

RfC. This is because RfCs are based on lower bounds 

on PODs and UFs are known to be protective. 

For risk management decisions, uncertainty in the RfC 

generally more important than imprecision, because 

managers are interested in making decisions that 

protect public health. 

27172.287

Hazard Range Development 

Hazard Range 

Floor 

Midpoint 

Ceiling 

27172.288

Floor of the Hazard Range 

Identified as the RfC/RfD based on a single 

candidate value 

In the case of an RfC/RfD based on two or more 

candidate values 

identified as the candidate RfC/RfD with the 

higher( est) confidence. 

The reference value is not likely to change with 

further testing, except for mechanistic studies that 

might affect the interpretation of prior test results. 

RfC could be modified if refined data are obtained to 

modify uncertainty factors - e.g., kinetic data for 

chemical-specific adjustment factors. 

27172.289

Floor of the Hazard Range 

The RfC/RfD is developed: 

o using UFs that are protective based on the 

observed behaviors of a typical toxicant 

so that the RfC/RfD is an underestimate of the 

expected threshold value. 

The floor of the hazard range may be denoted 

as a point below which risk managers are 

unlikely to recommend remedial action or 

exposure controL 

27172.290

Ceiling of the Hazard Range 

Is defined as the adjusted point of 

departure (PODadj) 

POD based on the critical 

concentration/ dose of chosen study. 

Managers likely to take regulatory action 

above this ceiling since specific toxic 

effects can sometimes be seen. 

27172.291

Ceiling:Adjusted POD 

@ Adjustments for the dosing regime in the critical study, 

such as ... 

Toxicokinetic differences between the test organism an

humans 

Database quality, lack of NOAEL, and study duration; 

reductions are based on available data, or a factor of 3 

used as a default for each area. 

The intent of these adjustments and reductions is to 

estimate the likely ceiling of the RfD/C by using the 

median value of the Ufs. 

27172.292

Midpoint of the Hazard Range 

Unlikely to be associated with adverse effects in 

human population, based on ... 

Greater understanding of the range of uncertainty 

associated with RfC/RfD development and 

c Consistent with the definition of how "uncertainty of u

to an order of magnitude" impacts the RfC/RfD 

It is a plausible estimate of the upper 

concentration or dose that is likely to be 

protective of the general population, including 

sensitive subpopulations 

27172.293

Midpoint of the Hazard Range 

Is a judgment that meshes four 

considerations: 

o Collective magnitude of the UFs 

o Steepness of the hazard slope describing 

exposures above the RfC/RfD 

o The confidence in the selection of the critical 

effect 

The confidence in the POD 

27172.294

TCE as an Example 

7. Different uncertamtv ranges for different TCE RfCs All an:• m ltg'n/. Shaded art:'as 

mdicat<' best onrall for ri>k purpose's. 

Endpoint Confidmce tJncert:unty Range

Smdy IRIS St<'<'P b Critical' Point of a Floor Intermediate 

t:r' Slope Effect 

Jolmson eta! Fetal Lower Low Low 2 10 

(2003) malformation 10 

TOXIC 

nepluopathy H1ghei .\fedmm 1i<'dium 3 9 :!\TP (1988) 10 to Low 

Decreased 

thvmus :JA .\iedmm 1\iedmm Ked 2 20 et aL 2009 wei gill 100 to Low 

a Size of the uncertainty factor as on IRIS 

b. Skepness of the hazard slop<' (i.e .. the slope of tl1e line describing hypothetical population responses at 

abow the RfC). a> per Section 3 

c Confidence m the choices of critical eff<'ct. as per Section -t. 

d Confidence in th<' POD. as per Section-t. 

27172.295

Practical Application of the Hazard 

Range for Noncancer Effect (e.g.,TCE

ES Figure la. Exposure dtstnbution of mdoor arr concentrations 

pnmarily below tl1e 3 pgim' to 20 flgJm3 hazard range. Relatively small 

propmtion of exposures is higher thau3 pg;m3 Nominal actiotl'> or no 

further action may be warranted for mk management 

ES Figure 1 b. 

mt!unthe 3 

of exposures t'> 

risk management 

....... "u.~..., ... "'._, .... of tndoor air conceutrntwns 

' ·d range Relallvely small proportion 

Lnmted actiollllu1Y be warranted for 

ES Figurf' lc. Exposure dtstribution ofmdoor arr concentratrou; pnmanlv 

above -the 3 1rg:m3 to 20 ftg'm' hazard range. Actions to reduce expo'>\ll'e~ 

may be wruranted for risk mnuagem<>n! 

27172.296

Summary of data for the Developm

of the Hazard Range for the Arsenic 

Chemical IRIS IRIS IRIS Steep Confidence Hazard Ranges 

Arsenic''' 

RID POD UP Slopeb (mg/kg-day) 

Critical Midpoint (mg/kg-day) Effectc POOd Floor (Inter- mediate) 

3E-4 8E-4 3 Low High Medium I E-4* 3E-4 

a. Size of the uncertainty factor as on IRIS 

b. Steepness of the hazard slope (i.e., the slope of the line describing hypothetical 

population responses at 

concentrations above the RfC), as per Section 3. 

c. Confidence in the choices of critical effect, as per Section 4. 

d. Confidence in the POD, as per Section 4. 

Ce

8E

27172.297

Summary of data for the Development 

the Hazard Range for the Chromium (V

Chemical IRIS IRIS IRIS Steep Confidence Hazard Ranges 

RfO POD UP Slopeb (mg/kg-day) 

Critical Midpoint (mg/kg-day) Effectc POOd Floor (Inter- C

mediate) 

Chromium 3E-3 2.5 300 X Low Low Low 3E-3 3E-2 3E

(VI) 3 L--~-------···- a. Size of the uncertainty factor as on IRIS 

b. Steepness of the hazard slope (i.e .. the slope of the line describing hyporhecical population responses at 

concentrations above the RfC). as per Senion 3. 

c. Confidence in the choices of critical effect, as per Section 4. 

d. Confidence in the POD. as per Section 4. 

•• 'Range judged to be 100 ls_ee text under "Evaluation") 

27172.298

Summary of data for the Development of t

Hazard Range for the Tetrachloroethylene 

Chemical IRIS IRIS IRIS Steep Confidence Hazard Ranges 

RID POD UP Slopeb (mg/kg-day) 

Critical Midpoint (mg/kg-day) Effectc PODd Floor (Inter- C

mediate) 

Tetrachlor 6E-3 6E-O 1000 Low High Low 6E-3 6E-2 6

oethylene 

a. Size of the uncertainty factor as on IRIS 

b. Steepness of the hazard slope (i.e., the slope of the !me describing hypothetical population responses at 

concemrations above the RIC). as per Section 3. 

c. Confidence in the choices of cmical effect, as per Section 4. 

d. Confidence in the POD, as per Section 4 . 

.. Range judged to be 100 (see text under "Evaluation") 

27172.299

Panel and Audience Comments ~ Midpoint" may not be an appropriate term, but rather a 

best estimate of the sensitive human LOAEL. The 

authors noted the intent for the "midpoint" was to 

identify a value that will protect sensitive populations, 

based upon greater understanding of uncertainty. 

When greater unce1iainty exists, one might want the 

"midpoint" to be closer to the RID, rather than farther. 

The authors noted that larger uncertainty suggests a 

larger range between the floor and the ceiling. 

Regardless, all agreed that it is important to clearly 

communicate that the value is a judgment. 

More comments at: 

http:/ /www.allianceforrisk.org/Workshop/WS 8/D R8 _ Meeting_Re

rt_ and_ Appendices. pdf 

27172.300

Hazard Range and the Problem 

Formulation 

Does the development of a hazard range 

help to address the following problems: 

Hazardous waste site remedial objectives for chronic exposure 

levels 

Communicating risk/hazard of exposure above RfC/RfD 

Prompt/short term exposure action levels 

Prompt action exposure concentrations 

Application of lifetime RfC/RfD to acute and subchronic 

exposures 

Confounding effects of assessing ambient background 

concentrations in air (TCE, Petroleum) 

27172.301

Summary 

The suggested method allows the development of a 

range in a non-cancer health risk value based on readi

available information. 

The development of floor, midpoint and ceiling of the 

suggested range is consistent with the problem 

formulations of risk managers at waste sites. This ran

may be helpful with other contaminated media. 

Science Panel comments suggested several 

improvements including the possible integration with 

work offered by Dr. Nancy Beck in the presentation o

"Understanding Uncertainties and Confidence in Haz

Databases: An Example Using IRIS." 
307 


27172.302

...... 

--

27172.303

Johnson et aL, 2003 

RfC = 2 ~g/m 3 Fetal malformation endpoint 

o Midpoint of I 0 ~g/m 3 is judged to be 5-fold 

above the candidate RfC due to: 

Its small UF of I 0, 

Shallower hazard slope, 

Low confidence in the critical effect, and 

Low confidence in the choice of a benchmark 

response of 1% (BMDL01 ) 

27172.304

0.05 

R 

e O.tl4 

s om 

p 

002 

0 

Hazard Ranges ofTwo Candidate 

RfCs for TCE (as per Gentry et aL) 

Figure 2. Hazard Range of Heart 

Malformations POD = BMD 

BMDriskupto 

0,0!1 

-linear[BMOriskupto) 

o oms o.m oms 

Concentration ppm 

0.05 

R 

0.04 

e 

s O.Dl 

p 

0.1)2 0 

Figure 4. Hazard Range of 

Nephropathy POD=BMD 

0.020 

BMD risk up to 

-linear (BMD risk up to) 

0.005 0.01 0.015 0.02 

Concentration ppm 

27172.305

NTP, 1988 

RfC = 3 tJg/m3 

• Toxic nephropathy endpoint 

Midpoint of 9 1Jg/m3 is judged to be 3-fold 

above the candidate RfC due to; 

Its small UF of I 0, 

Steeper hazard slope, 

Medium confidence in the critical effect, and 

medium to low confidence in the choice of a 

benchmark response of 5% (BMDL05) 

27172.306

Keil et al., 2009 

RfC = 2 tJg/m3 

Decreased thymus weight endpoint 

o Midpoint of 20 J.Jg/m3 is judged to be I 0-fold 

above the candidate RfC due to: 

Its larger UF of I 00, medium confidence in the 

critical effect, and medium to low confidence in its 

choice of a LOAEL as the POD 

The effect shown by Keil et al. (2009) does not len

itself to dose-response modeling, so steepness of 

the slope was not assessed 

27172.307

Arsenic as an Example 

Oral RfD Summary (after IRIS) 

Critical Effect Experimental Uf Mf RfD 

Doses 

Hyperpigmentation, NOAEL: 0.009 mg/L, 3 I 3EA 

keratosis and possible converted to 0.0008 mg/kg-da

vascular complications mg/kg-day I 

Human Chronic oral LOAEL: 0.17 mg/L, I exposure converted 

Tseng, 1977; I to 0.0 14 mg/kg-day 

Tseng eta/., 1968 

I 

27172.308

Chromium (VI) 

Oral RID Summary (after lRJS) 

C1itical Effect Expe1imental Doses I UF MF RfD 

None RepOited NOAEL: 25 mg/L of chromium 300 3 I 3E-3 as K2Cr04 I 

Rat, 1-year drinking mgjkg-day 

water study 2.5mgjkg-day (adj.) 

MacKenzie et al,1958 

27172.309

Tetrachloroethylene 

Oral RID Summary (after IRIS) 

Principal Study/Critical Effect POD 

I 

UF I Candidate RIDs I R

(mg/kg·day)' (mg/kg·day) I (mgjk

Echevenia eta/. (1995): LOAEL = 9.7 1.000• 0.0097 I 

neurotoxicity (reaction time, I cognitive effects) in I 

occupationa!ly·exposed adults 

0.

LOAEL: 2.6 1,000• 0.0026 

'Dertved by route-to-route extrapolation from inhalation exposure using PBPK model of Chin and Gi

(2011). 

"The RID is supp01ted by the two principal studies, as a midpoint of the range of available values (th

rounded to one signifkmt figure). 

•judged to be 100 (see text under "Evaluation") 

27172.310

Table 1. Summary of data for the Development ofthe Hazard Range for the ,'\rsenir, 

Tetrachloroethylene and Clu·ominm (VI) RfDs on IRiS (2014:). 

(All values for these ranges are in mgjkg·day). 

I C<>nfid~nce Hazard Range

{mg/kg-day) I I I Critical Point of Floor }liduoint Effect< Oepartureli {lllt•rm~dia~e 1 

Ar:;enic" :lE-4 SE-4 3 L<>w High Medium 1E*41 3£-4 

Tetrachtor-ott.hyl· 6E-3 6E-O lDDO low 

-en-e 

Chromium (Vl) 3E:<? 2.5 300' 3 Low 

tThe floor to cei!ing range d;S found on !RlS 

uRange judged 10 be 100 hee text under "'Eva,1uation"f H•Rane~ !udeed to be 100 (see text under 4 Evaiw:;tion;r} 

a. Size of the uncertainty factor, a:i pH IRIS 

High Low 6E-3 6E-Z 

Low L<>w 3E-3 3E-2 

b. Steepness of the haz;;rd slope (i.e., the slope of a hypothetical •tne desCfib!ng population respomes at 

co~tentrations above the RfD), as per Section 3 of eth case Study Report" 

c. Confidence in the choKes of critical e!rect, as per Section4 of the Cose Sll.ldy Report. 

d Conftd€nce In the point of depant.m:% as per ~ctiDn 4 of eth Case Stud'{ Report. 

27172.311

The concept of hormesis and 

application in risk assessment 

Michael Dourson with help from Ed Calabrese 

Risk Science Center (aka, TERA Center) 

University of Cincinnati, College of Medicine 

OF 

Cincinnati 

27172.312

Abstract 

• Low dose non-monotonic (LDNM) behavior occurs routinely 

biological systems. Such behavior can be due to essentialit

toxicology masking or hormesis. 

• Hormeisis is characterized by low-dose adaptive effect and 

high-dose adverse effect. 

• As with other LDNM, hormesis depends on endpoint measu

and chemical mode of action (MOA). 

• Because the hormetic biphasic dose response may represen

general pattern of biological responsiveness, or is otherwise 

part of the adverse outcome pathway of many chemicals, i

should become progressively more significant within risk 

assessment practice. 

tJNIVfRSlTY OF 

Cincinnati 2 

27172.313

HORMESIS CONCEPT 

• Low doses of numerous stressors (e.g. 

exercising, intermittent fasting, hypoxia, he

cold, ionizing/non-ionizing radiation, 

electricity, toxins, chemicals/drugs) can 

stimulate a wide range of adaptive respons

• Calabrese, numerous citations 

UNIVERSITY Of 

Cincinnati 
319 


27172.314

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27172.315

A Variety of Possibilities 

Essentially(--), Hormesis (-),Toxicity(---

Cancer ( ... ) LDNM (red) 

r 

Background!~·-( 

-~-~---7 /-

Range 

1 

Effect 

Wherein lies endocrine 

disruption? 

Increasing Dose 

27172.316

Mechanisms for LDNM (partial) 

• Essential nutrients such as chromium & copper 

• Overcompensation & induction of protective respons

increased heat shock proteins from mild heat stress or 

gutathione from oxidative stress 

• Benefits and risks to different organs---low dose ethan

benefits in heart, but high dose problems in CNS & liv

• Shifts in response spectrum cyclophosphamide 

increased resistance to flu; decreased resistance to tum

• Stimulatory and inhibitory receptors within same orga

(apomorphine) 

• Masking---antimicrobial stimulation of growth maskin

overall toxicity measured by changes in body weight 

UNIVERSITY OF 

Cincinnati 6 

27172.317

A Way Forward? 

Case by Case (current approach for essential nutrients) 

A Mode of Action (MOA) approach: Are MOAs the sam

and effect severities similar? 

OF 

No and No? Develop "RDA" and RSD/RID, allow overla

biology indicates, or plot composite effect/benefit curve by 

categorical regression 

No and Yes? Plot composite data using new models, deten

nadir 

Yes and No? Plot composite effect/benefit curve by addre

severity via categorical regression 

Yes and Yes? Plot with new models, determine nadir 

Cincinnati 7 

27172.318

Is mechanism the same? Effect severity similar? 

Adverse 

l 

Background 

Range 

No and No: Develop , and orR 

combine curves (as below) or model via 

categorical regression 

Point o

1 I RSD 

Increasing Dose 

27172.319

Is mechanism the same? Effect severity similar? 

No and Yes: Plot composite data using new 

models, determine nadir 

•Total mortality: J-shape 

response for ethanol 

intake 

•Cancer: no apparent 

increase until higher 

drinking levels 

•Cardiovascular: Ushaped response 

•Coronary Heart Disease: 

L-shaped threshold effect 

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27172.320

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Is mechanism the same? Effect severity similar? 

N~ and Yes~ Plot composite data using new 

models, determine nadir 

140·r-----------------------------------~=======

~Fcmall's 

120 

...... "•''" 

100 -~ '-.~ "-- - -- - - - --------

-----------

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80 

60 

40 

Methanol and Fruit Fly Longevity 

20 1 (courtesy of Professor Calabrese) 

0~----~------~----~------~------~---

_o.oo 0.25 0.50 1.00 2.00 4.00 

Cincinnati 

27172.321

250 

200 

150 

10(! 

Is mechanism the same? Effect severity similar

Yes and No: Plot composite effect/benefit curve b

addressing severity via categorical regression. 

Effect of DDT on Liver Foci 

Formation in Male F344 Rats 

(courtesy of Calabrese) 

50 -1 * 

0 ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~· ~· ~· ~· ~· ~· ,. ~- 0· ~· ~· ~· ~ ~ ~ Of 

Cincinnati 11 

27172.322

Is mechanism the same? Effect severity similar

Yes and No: Plot composite effect/benefit curve b

addressing severity via categorical regression. 

140 .-----------------------------------------------120 

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Gamma Rays and Mouse Lung 

Adenomas (courtesy of Calabrese) 

10 25 50 100 150 200 

Gamma Ray Dose (rad) 

27172.323

Is mechanism the same? Effect severity similar? 

Yes and Yes: Plot using new models and determin

nadir 

•Survivors of Hiroshima 

and Nagasaki 

• Radiation hormesis 

•8 cGy is optimum for 

suppression of leukemia 

•Dr. Luckey's claim that 

"low dose radiation is 

stimulating and essential 

for life!" 

UNI\IfliSITY OF 

Cincinnati 

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27172.324

Is mechanism the same? Effect severity similar? 

Yes and Yes: Plot using new models and determi

nadir 

•DR curve with minima at 

the middle dose at 18 mos. 

And a minima at the low 

does at 24 mos. 

•Survival at 0 dose keeps 

deteriorating with age. 

·Mortality is inhibited at the 

medium doses of 

compound. 

UNIVERSITY OF 

Cincinnati 14 

25 

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15 

0 

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Mortality in CR B6C3Fl Mice 

Function of Benzvl Aceta

• 24 Months 

· •-- 18 Months 

1000 2000 

Dose (ppm) 

27172.325

Is mechanism the same? Effect severity simila

Yes and Yes: Plot using new models and 

determine nadir 

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Methyl mercury on mitochondrial 

dehydrogenase in the 0407 Cell Line 

(courtesy of Calabrese) 

0 +---~----~--~----~--~----~-----

0.0 0.1 0.5 1.0 5.0 10.0 25.0 500.0 

Methyl Mercury (~M) UNIVERSITY OF 

Cincinnati 

27172.326

urrent Issues and Activities: 

Critical Effect & Point of Departure 

Trend: better characterizing dose response of critical effect 

low-dose region. For example, 

- Benchmark dose (BMD), and 

Markov-Chain Monte Carlo for toxicokinetic models 

(Andersen and Clewell, multiple publications). 

- Cooperative agreements to address dose-response 

approaches for mutagenic chemicals (Moore and Hab

2006). 

- Evaluation of severity, adversity, adaptation, 

compensation, in critical eff

UNIVUfSITY Of 

Cincinnati 16 

27172.327

Current Issues and Activities: 

Use of Precursor Data and Adverse Outcome Pathw

Trend: increasing use of precursor data to judge mode of ac

For example, 

- Meek et al. (2008, 2014) Mode of action frameworks 

evaluating experimental anima] evidence in relationsh

to humans. 

- U.S. National Institute for Occupational Safety and 

Health research for evaluating biomarkers; includes 

Bayesian network for using biomarker data. 

OF 

U.S. Environmental Protection Agency (EPA) researc

on the pathology-physiological progression to develo

criteria to categorize endpoints (AOPs). 

Cincinnati 17 

27172.328

Current Issues and Activities

Uncertainty Factors 

rend: using chemical data to move from default values of 

fold. For example, 

• International Programme on Chemical Safety (Meek et al

1994; IPCS, 2005; EPA, 20 13) methods for using chemic

specific adjustment factors (CSAFs). 

• SOT Award-winning papers on implications of genetic 

polymorphisms for development of uncertainty factors an

CSAFs (Nauman et al., 1998; Haber et al., 2002). 

• The default is to use data; use 1 0-fold reluctantly. 

UNIVERSITY OF 

Cincinnati 18 

27172.329

Implications for Essentiality Risk 

Characterization 

A Risk Assessment Definition for Elements ... 

Statistical or biological significant increases in adverse 

effects at both lower and higher doses from an optimal 

background point in the dose response curve. 

A Risk Assessment Definition for s . " . 

Statistical or biological significant decreases in advers

effects below background in the low dose region. 

With either definition, low, but yet still measurable doses, 

exhibit a positive, beneficial effect. 

UNIVERSITY OF 

Cincinnati 19 

27172.330

Conclusions 

• The existing risk assessment & management model is 

general and can incorporate essential elements, but it 

lacks precision. 

• Hormesis is a general biological concept. ]t represents 

adaptive strategy through which biological performanc

is enhanced and mediated. 

• A mode of action framework may provide approaches 

for characterizing risk and benefit of hermetic and othe

LDNM elements, but must address the differing severi

of effects, perhaps through categorical regression. 

Of 

Cincinnati 20 
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27172.333

Managing the Non-Cancer Risks a

Hazardous Waste Sites: Trichloroethylen

(TCE) as a Case Stud

Scientists • 

Michael Dourson, Risk Science Center, URod Thompson, Risk Options, LLC 

Edward Pfau, Hull and Associates 

27172.334

Abstract 

• The 2011 EPA reference concentration (RfC) TCE presents 

managers evaluating vapor intrusion with two challenges

- Discerning TCE concentrations that are attributable to subsurfac

contamination, and 

- Selecting remedial objectives that result in acceptable indoor TC

levels. 

• RfCs exhibit several precautionary adjustments, but do n

show a range as for cancer (i.e., 10-4 to 10-6 ). Thus, risk 

managers do not often consider an RfC range when decid

• A method for determining the safety range for non cance

hazard is presented: 

- Comparable to the cancer risk range 

- Consistent with the uncertainty inherent in EPA's RfC calculation

- TCE Safety range was judged to be 3 to 30 (11g/m3). 

27172.335

State's Relocation or Immediate Response Action Le

Immine

Urgent/lmmedia Urgent/lmmedia Imminent Action 

te Action te Action Action Commer

Problem State Residential Commercial Residential al 

Formulat 

ion: So 

which Alaska 2 8.4 

"sa fen California 6 (24) 

levels are Connecticut 5 8 

correct? Indiana 20 

Massachusetts 6 24 20 60 

New 

Hampshire 2 8.8 

New Jersey 4 18 

New York 20 

Ohio 6.3 26 20 60 

Region 09 6 24 

Region 10 2 8 

Region 7 2 8 

27172.336

State's Very Rapid Response Action Leve

Imminent Imm

Urgent/Immediate Urgent/Immediate Action Act

All of these State Action Residential Action Commercial Residential Comm

are in the 

safe range / 

for the Alaska /_.....// 2 8.4 

appropriate Californ)a/ 6 (24) 

group! 5 8 

lfidiana 20 

' 

Massachusetts 6 24 20 6

New Hampshire 2 8.8 

New Jersey 4 18 

'New York 

\ 

20 

Onlo 6.3 26 20 ',, 

6 24 

" 

Region 10 ·"'----- 2 8 Region 7 

--_, 

2 8 ------· -----

27172.337

Problem Response: Alliance for Risk 

Assessment (ARA) 

• ARA Steering Committee accepts proposal Summer 201

,. United States Army Corps of Engineers, Oregon Department of Environmental 

Indiana Department of Environmental Management, U.S. Environmental Protec

Agency (EPA), University of Cincinnati, College of Medicine, Texas Commission o

Environmental Quality, Agency for Toxic Substance & Disease Registry, Neptune 

Company, Inc. 

• TCE Workgroup formed in the Fall of 2012 

,- Open invitation, broad interest and participation 

,_ Trichloroethylene {TCE) Risk Assessment Guidance for Contamin

Sites {April 2013) ~ Webcast: Practical Guidance for Contaminated Sites: TCE Risk 

Assessment Case Study (November 4, 2013); over 300 scientists 

multiple international organizations, including government, indu

academia and NGOs, on 6 conference calls and one webinar. ~ Alliance for Risk Assessment (ARA) review Summer of 2015 

,_ Publication in the Spring of 2016 
343 


27172.338

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27172.339

Purpose: Guidance for Noncancer Range 

at Contaminated Sites 

• Develop a range in noncancer risks, similar to the range used 

for cancer risks in management of waste sites, using readily 

available information from U.S. EPA and elsewhere. 

• Create range to enable evaluation of uncertainty in the 

noncancer benchmark. 

• Demonstrate confidence in this range so that the range can 

be considered in the determination of management choices

~Building a Risk Assessment Commun

27172.340

NAS (2014) & IRIS Process 

• Finding: EPA could improve documentation and 

presentation of dose-response information. 

• Recommendation: EPA should c1early present two dose

a 

The lower bound becomes an upper 

bound for a cancer slope factor but remains a lower boun

for a reference value." 

27172.341

NAS {2014) & IRIS Process 

• Finding: IRIS-specific guidelines for consistent, coherent

transparent assessment and communication of uncertainty 

remain incompletely developed. The inconsistent treatme

uncertainties remains a source of confusion and causes 

difficulty in characterizing and communicating uncertainty

• Recommendation: Uncertainty analysis should be condu

systematically and coherently in IRIS assessments. To tha

end, EPA should develop IRIS-specific guidelines to frame 

uncertainty analysis and uncertainty communication. 

Moreover, uncertainty analysis should become an integral 

component of the IRIS process. 

27172.342

Developing the Range 

. . _. . an 

of a daily oral (for RfD) or continuous 

inhalation (for RfC) exposure to the human population 

that is likely to be without an 

appreciable risk of deleterious effects during a lifetime. 

• Arsenic RfD on IRIS. 

- There was not a clear consensus among Agency scientists on the oral 

... ,-,'"""' Applying the Agency's RfD methodology, strong scientific arguments can be made for various values within a factor o

2 or 3 of the currently recommended to 

It should be noted, however, that the RfD methodology, by 

definition, yields a number with inherent uncertainty spanning 

perhaps an order of magnitude. 

ARA 

~Building a Risk Assessment Commun

27172.343

Developing the Range (can't) 

• In the IRIS Summary for TCE, U.S. EPA identified three 

candidate RfC values from principal and supporting studies fo

the noncancer inhalation toxicity of TCE. These are: 

RfC of 2 11g/m3 based on decreased thymus weight in 

female mice (Keil et al., 2009); 

RfC of 2 j.l.g/m3 based on fetal heart malformations in rats 

(Johnson et al., 2003); and 

RfC of 3 11g/m3, based on toxic nephropathy in female rats 

{NTP, 1988). 

• Each of these candidate RfCs may be evaluated with respect 

to the imprecision and the uncertainty inherent in its 

derivation. 

ARA 

~Building a Risk Assessment Commun

27172.344

Imprecision Versus Uncertainty 

• Imprecision of a RfC is on both sides of the RfC. This is 

because a 2nd expert group might estimate a RfC higher or 

lower than the pt group, if given the same information. 

• Uncertainty in a RfC, in contrast, lies mainly above the RfC. 

This is because RfCs are based on lower bounds on points of 

departure & uncertainty factors are known to be protective. 

• For risk management decisions, uncertainty in the RfC is 

generally more important than imprecision. Managers are 

interested in making decisions that protect public health and 

uncertainties in a RfC are generally more informative. 

~Building a Risk Assessment Commun

27172.345

Different Uncertainty Ranges for TCE RfC

Table 7. Uncertainty ranges for different TCE RfCs in )lg/m3 . Shaded 

areas indicate best overall uncertainty range for risk management. 

Confidence Unccnainty Ranges 

Study IRIS Steep h Critical~ Point ofu Floor Intermediate Ce

UFa Slope EfTect Departure 

Johnson ct al 10 Lower Low I 10 

(2003) Low 

Higher Medium Medium NTP ( 1988) 10 '"' 9 

to Lcrw .) 

NA Medium Medium Keil et al. 2009 100 2 20 

to Low 

. - . 

27172.346

lue!m' 

'"" 

CotK-itJt,/rn'I 

IJ 

c~,{l.lg/m'i 

Figure 3a. Exposure distribution of indoor 

concentrations primarily below the 3 ~g/m 

to 20 ug/m3 hazard range. Relatively small 

proportion of exposures is higher than 3 

~gfm Nominal actions or no further actio

may be warranted for risk management. 

Figure 3b. Exposure distribution of indoor 

concentrations falling within the 3 ~g/m 3 t

20 ~g/m 3 hazard range. Relatively small 

proportion of exposures is higher than 9 

~g/m • Limited action may be warranted fo

risk management. 

Figure 3c. Exposure distribution of indoor 

concentrations freqeuently above the 3 ~g

to 20 ~g/m3 hazard range. Actions to redu

exposures may be warranted for risk 

management. 

27172.347

Exposure Scenario 

Residential 

Commercial (8 hr) 

Response Action 

TCE Action Level Decision Matrix 

Chronic Response 

ug/m3 

>3.2 but < 9.4 

> 13 but< 39 

Accelerated Response 

ug/m3 

> 9.4 but< 21 

> 39 but< 88 

Within months coordinate Within weeks coordinate 

with local or state with local and state 

Prompt Action 

ug/m3 

> 21 

> 88 

Within days coordina

with local and state 

personnel to communicate personnel to communicate personnel to commun

risk from long-term risk from short term risk from several days 

exposures. 

Based on chronic 

exposures, remedial 

objectives can be based 

anywhere in the range of 

3.2-9.4 ug/m3 (residential) 

or 13-39 ug/m3 

(commercial) 

within 6 months. 

exposure. 

Based on short term 

exposures, remedial 

objectives can be based 

anywhere in the range of 

3.2-9.4 ug/m3 (residential) 

or 13-39 ug/m3 

(commercial) within 10 

days to 3 months. 

exposure. 

Based on acute expos

remedial objectives c

based anywhere in th

range of 3.2-9.4 ug/m

(residential) or 13-39 

(commercial) within a 

matter of days. 

27172.348

Summary: Noncancer Range 

at Contaminated Sites 

• A noncancer range was developed for the TCE RfCs. Range 

included floor, midpoint and ceiling. 

• Range for EPA's TCE RfC was judged to be 3 to 30 f.J.g/m

3

. 

" The results of the NTP study-based RfC were used to determine the 

floor and midpoint of this uncertainty range. 

• The highly controversial results from the Johnson et al. {2003) studybased RfC, while associated with low confidence, were considered for 

the ceiling level, but journal peer review recommended against this. 

• This 3 1J.g/m3 to 30 1J.g/m3 range was entirely within the wider 

individual uncertainty range from the Keil et al. {2009) study; therefor

this latter study was considered to be confirmatory. 

~~Building a Risk Assessment Commun

27172.349

Need for Further Effort 

• Continue this dialogue regarding vapor intrusion risk 

assessment issues, including agencies and responsible partie

• Study the proposed method for the noncancer risk range. 

• Resolve discrepancies in TCE fetal heart findings from one la

compared with negative findings in all other labs. 

• Determine appropriate TCE safe range & averaging time. 

Building a Risk Assessment Commun

27172.350

For more information go to: 

http://www. a IIi an cefo rr is k. o rg/ P raj ects/T CE.html 

Michael Dourson, michael.dourson@uc.edu 

513 558-7949 

ARA 

~Building a Risk Assessment Commun
356 


27172.351

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27172.352

Perchlorate 

Reference Dose (RID) 

Joan Dollarhide 

Jay Zhao 

Mike Dourson 

Toxicology Excellence for Risk Assessment 

(TERA) 
358 


27172.353

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27172.355

Decreased T4 is Critical Effect 

• Mode of action analysis shows inhibition of iodine upt

is biologically effective dose and altered honnones ear

biological effect 

• In hutnans, decreased T4 in both pregnancy and infanc

known to increase potential for thyroid and nervous sy

toxicity; no such knowledge for iodine inhibition 

• In perchlorate rodent studies, altered horn1ones occur a

lower doses than other thyroid and nervous systetn effe

Pregnant rats have n1ost dran1atic response. 

• Decreased T4 not adverse itself- changes in this horn1

'--' 

occur every day. Rather decreased T 4 is a precursor to 

ad verse effect. 

• Basing an RID on decreased T4 will prevent all subseq

potential adverse effects. 

27172.356

Human Studies Most Appropriate 

Critical Studies 

• Several well-conducted hun1an studies available, includ

occupational, epiden1iology, clinical studies. 

• One ofthe sensitive subpopulations, neonates/children, 

well studied. 

• Although kinetics appear sitnilar between rodents and 

hu1nans, dynan1ics dran1atical1y different (i.e., 1 0-fold) 

• In hutnans, no decrease in T4 observed at any dose test

even when serun1 perchlorate levels sufficient to result 

up to 70o/o iodine uptake inhibition, cotnpared to rats. 

• Iodine uptake inhibition different in hutnans and rats. 

27172.357

Human T4 Response to Perchlorate D 

140 

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Serum Perchlorate Peak Cone

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27172.358

----e-- P1 GD20 (Yu 2000b) 

____.____ P1 PND5 (Yu 2000b) 

--+- P1 Rat GD20 (York 200

-e- P1 Rat PND10 (York 20

P1 PND22 (Mahle 2001

.. 
364 


27172.359

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27172.360

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27172.363

Co-critical Study: Crumpet al., 2000 

• Epidetniology study of 9784 neonates and 162 school-

children. 

• TSH and free T4 n1easured compared in residents of 3 

cities in Chile. Measured perchlorate concentrations: 

Taltal - 1 00-120 ug/L 

Chanaral 5-7 ug/L 

Antofagasta - <4ug/L 

• No effect on TSH or T4 observed in neonates or childr

in any city. 

• Freestanding NOAEL of 0.006 tng/kg-day estitnated b

on estitnated child drinking water consutnption of 1.5 

L/day and body weight of 28 kg. 

27172.364

Co-critical Study: Greer et al., 2002 

• Clinical study of 37 n1ale and fen1ale healthy volunteer

exposed for 14 days 

• Perchlorate in drinking water at doses of 0.007, 0.02, 0

and 0.5 rng/kg-day 

• Iodine uptake and thyroid para1neters evaluated. 

• No statistically significant effects on T4; good doseresponse for inhibition of iodine uptake. 

• Identifies a NOAEL of 0.5 1ng/kg-day. 

• BMD analysis of iodine uptake inhibition (BMDL20 = 

n1g/kg-day) selected as conservative, quantitative NOA

surrogate for RfD develop1nent 

27172.365

Different Perchlorate RIDs 

Group TERA TERA EPA OEHH

2002 2002 2002 1002 

proposed supporting proposed propo

Critical Effect T+ decrease Adult iodine ScYeral Adult io

in children inhibition effects inhibiti

Study Crumpet 3 human PSU. 200 l Greer ct 

al.. 2000 clinical studies 2002 

BMDL NOAU .. or LOld~L !Iuman l I uman Rat ]Iuma

(mgJ.:g-day) NO!\El BMDL2o LO!\EL BMDL

0.006 () .() 2 0.01 ().()()3 

Total Factor 3 10 300 30 

1\JD (mgl.g-day) 0.002 0.002 0.00()03 0.000 

Conlidcnce in Rll> I !igh lligh Medium NA 
371 


27172.366

(/) 

()) 

(/) 

..,- • 

_. 

' 

(\} 

0.. 

8:.1 

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<:t 

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1-

o6 

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Ill 

-g 

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<( 

<r. 

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,.., 

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0 

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c: 

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"' 

... 

1/l 

.. 

01 

Ill 

$. 

.. 

~ "' 

c() 

.-

0 

27172.367

2 

1.8 

1.6 • 

1.4 • 

1.2 

0.8 • 

0.6 • • 

04 

0.2 

0 

0 5 10 

Antofagasta & Taltal, Ln(1+TSH) 

15 

• 

• 

• 

• 

20 

Weeks gestation 

25 

• Antofagasta 

• 

30 35 

27172.368

Acknowledgement 

TERA wishes to thank the Perchlorate Study Gro

for its support over a nutnber of years to study 

perchlorate's toxicology and assess its risk. 

Ho\vever, support for the development of this 

tnanuscript was provided only by internal 

developmental reserve funds of TERA, and not 

any outside party. 

Furthermore, our deliberations shown in this pap

have not been influenced by discussions with 

outside parties. 

27172.369

History ofTERA Coordinate

Public/Private Partnership o

Perchlorate Research 

Mike Dourson, Ph.D., DABT 

Toxicology Excellence for Risk 

Assessment (TERA) 

Toxicology Excellence for Risk Assessment 

27172.370

Toxicology 

Excellence for 

Risk 

Assessment 

is a non-profit 501(c)(3) corporati

dedicated to the best use of toxicity d

for risk assessment. 

Toxicol0!2;V Excellence for Risk Assessment 

27172.371

One ofTERA's Activities 

• Improve the practice of risk assess1nent b

industry and government through inform

and neutral guidance and advice 

Toxicolo.sr;y Excellence for Risk Assessment 

27172.372

History of Perchlorate RfD 

• EPA Superfund provisional Reference Dose 1992~ rev

1995 

• TERA RfD and expert peer review 1997 - data are 

inadequate, suggest specific studies 

• 1997-1999 Air Force and PSG complete recommende

studies 

• 1999 EPA draft document and RID based on new data 

reviewed/ peer review 

• 2000-2002 Air Force and PSG completed additional 

studies 

• 2002 EPA revised draft risk assessment and RtD/ pee

rev1ew 

Toxicology Excellence for Risk Assessment • 

27172.373

EPA Provisional RfD 1992 

• EPA Superfund Technical Support Center 

• Based on acute study in patients with Grave

Disease (Stanbury and Wyngaarden, 1952) 

• NOAEL 0.14 mg/kg-day- release of iodine 

thyroid followed by incomplete inhibition o

iodine uptake 

• Uncertainty factor 1 000 ( 10 each U fH, UF s, 

UF

0 ) 

• RID of0.0001Ing/kg-day =ground water 

screening level of 4 ppb 

Toxicolo.gy Excellence for Risk Assessment 

27172.374

EPA Provisional RfD 1995 

• EPA Superfund Technical Support Center • Based on acute study in patients with Grav

Disease (Stanbury and Wyngaarden, 1952) 

• NOAEL 0.14 mg/kg-day - release of iodine 

thyroid followed by inco1nplete inhibition o

iodine uptake 

• Uncertainty factor 300 to 1000 (10 each UfH

UFs, 3 to 10 for UFn) 

• RID of0.0001 to 0.0005 mg/kg-day =grou

water screening level of 4 to 18 ppb 

Toxicolozy Excellence for Risk Assessment 

27172.375

TERA Expert Peer Review 

1997 

• Additional literature search to answer 

outstanding questions from EPA provisio

RID 

• Considered Caldwell study, not available 

EPA 

• Developed a RID based on similar datab

as EPA's RID, peer reviewed in 1997 

Toxicology Excellence for Risk Assessment 

27172.376

TERA Expert Peer Review 

1997 

Conclusion: 

Perchlorate database insufficient 

to develop any RID 

Major unanswered questions: 

» shape of dose-response curve in humans » effects from long-term exposure » possibility of effects in organs/systems other than 

thyroid 

Toxicology Excellence for Risk Assessment 

27172.377

Recommended Studies 

• Neurobehavioral developmental • 90-day subchronic oral bioassay 

• Segment II developmental 

• Two-generation reproductive 

•ADME 

• Genotoxicity assays • Immunotoxicity studies • Mechanism studies 

Toxicology Excellence for Risk Assessment 

27172.378

TERA Coordinated Studies 

• TERA, in association with the U.S. Air Force, 

U.S. EPA, the Perchlorate Study Group and 

others, has helped in developing a research 

progrmn and protocols for studies that will fill 

the data gaps that existed in the toxicology 

database. 

• Studies were funded by the U.S. Department o

Defense and Perchlorate Study Group. 

• TERA monitored these studies. 

Toxicolog.y Excellence for Risk Assessment 

27172.379

EPA 1999 RfD 

• Minitnal LOAEL of 0.1 mg/kg-day for thyroid 

hypertrophy and decreased lumen size in PND5 

pups (Neurodevelopn1ental study, Argus 199R) 

• Experimental dose of mnmoniu1n perchlorate 

adjusted by 0.85 to estimate dose of perchlorat

. 

IOn. 

• RfD of 0.0009 tng/kg-day = DWEL of 32 ppb 

water 

Toxicolozy Excellence for Risk Assessment 

27172.380

Studies Conducted In Response to 19

Peer Review Recommendations 

• PWG reevaluation of all thyroid histopatholog

• Predictive itnmunotoxicity studies • Develop1nental toxicity study in rats 

• "Effects study" 

• Motor activity study 

• Epidetniology and clinical hu1nan studies 

• PBPK 1nodeling 

Toxicolozy Excellence for Risk Assessment 

27172.381

EPA 2002 RfD 

• MOA- any transient decrease ofT4 can have 

efiect on neurodevelopment 

• LOAEL ofO.Ol mg/kg-day based on decreased 

in rat datns and brain Inorphotnetry in rat pups 

(Efiects Study, Argus, 2001) 

• Supported by BMDL analysis of colloid deplet

and thyroid hypertrophy in 1nultiple studies and 

novel statistically analysis of motor activity 

studies 

• LOAEL adjusted by 0.85 to estin1ate dose of 

perchlorate ion 

Toxicol0£v Excellence for Risk Assessment 
387 


27172.382

c '" 

• g ~11 0 

~· c 2 ~ :OJ " < ~ "' ::.: ;;:i 'J jj j' - ;...: ~ 'J ~ 

c :.r, - f- ~ 4 - < ~11 2 g E ~ j - -· L 

n 'J 4 / 

2 ~ ~ " / " " 2:: i :_; / 6 "· , .. 

g ·- "'-' ·- N ·= "" " " c ·- ~I; ~ 

~ -g C' '"" ~ g ":;/, 

0 Vi "8 ·~ ;:; - E ~ c 

~ ~ " ' ~ - ~I ~ ·- ;::; .., ~ 5 . f"\ :: ~ ~ 

VJ ~ s l ,/, < c -2. .c E 

~ ..1 ~ c. E' ~ c. ~ ~ .!d c " g_ - g ~ ., ·:;:; ~ ., 

] <iJ 

~ "' ., •r. " -g < = c 

=- ~ 2 " f -o ;:; g ~ 

=- 5. "- ~j ·~ " ., 

~ =- "" ~ I ~ -::; ·- ·- 6 ~ ;;- ¥1 ..c 

~ "' ~ 

.= t; "B ~ - "" "· ~ " "' -o }J· "' .~ <E L " :.....; " ~ ~ ~ 

~ :::: ~ n. " Cfi §- .:.. 

~ g .= <iJ 

~ < ) " .= ~~~ " ~ " " "- c. - = - (,) -. . .::: '· .::: c; " ~· ~ ] ~ 

~ :; " ""i) _, 

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E "' "' ''· ;:; " f. 

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g ...... ~ g .c "8 :>'; 

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~ " ;:: - -::; E / ';!I ~I E: ~ "? 

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if: ,g z c ~· "- " " ~ c. ;:; "' = c "" 'J 

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(..! :r; v z 'J c 

~ ;2 . ;:; § 

27172.383

TERA Provides Public Access to The

New Study Results 

• TERA website: www.tera.org 

• Presentation at Scientific Conventions: S

&SOT 

• Provides co1nments on EPA's assessment 

• Publications in peer reviewed journals. 

Toxicol09;y Excellence for Risk Assessment 

27172.384

TERA Website Provides Public 

Access to PSG Study Results 

• 1997 peer review comments, 

• Study designs, 

• Study results, 

• Data analysis, 

• Related publications, 

• TERA independent assessment. 

Toxicology Excellence for Risk Assessment 

27172.385

New Manuscript 

• Reference dose for perchlorate based on 

hu1nan studies. 

• Submitted for publication, peer reviewer

comments received, under revision. 

Toxicolozy Excellence for Risk Assessment 

27172.386

Data-Derived Replacement 

Default Uncertainty Factor 

Michael Dourson 

and 

Patricia Nance 

Toxicology Excellence for Risk Assessment 

( TERA) 
392 


27172.387

% Mortality jProbit Scale) 

l01110000000001()N 

Ill Ill Ill Ill t- 111111, 1'1 N " 

27172.388

~~ Intraspecies Variability 

R 6 

100 

r-- 4 

go - -

150 - Dourson and Stara, 1983 10 

70 r-"-

.... ~ <:,.I 

= 

eo ~ = 0'" 50 1~ 16 ·;.. r'-

i: ~ .&.() ,,., 

..... 

30 

20 

10 

30 (H 1.4 -· . -

I l '- ~ !___ !__ . . ' I 

:J 10 :JO 100 

lntraspecies Adjustment Factor 

Frequency vs an intraspecies adjustment factor obtained by raising 10 to the pow

standard deviations+ the probit, log-dose slope). Probit, log-dose slopes are show

within the figure 

27172.389

Cumulative 

response as a 

function of dose 

for humans and 

rats 

Response as a 

function of dose for humans and 

rats 

Dourson et al, 

2002, In review 

)'\1) 

" 

;;; 1,() 

" 

. I / --- " 

\.t )\ll/ 

··:B\IJ) I 

.j{j I I 

/ // 1 \nmk1l \( l:\1 J 

+·-i_J,,-- .,./ l'l· } .--....-..---!•rB\\1) 

101! 

\}() 

80 

70 

.J 

:::::: 

·----··-1> • .-

<•()\ • 

R.!D '" Dose 

llum.n '\.{!,\! 

PfB\1\) 

30 I 1 ,\nnn.d :,.i J\1! 

'mii\1/ 

co 2. ll. • 8' ,. 10 . 

0 T n- llme 0.1 0.01 RIP Ill 

! 

liunun 

f<;l! 

I Oil 

27172.390

• 

Response as a function of dose fo

humans of different sensitivities 

Dourson et al, 

2002, In review 

,_, 

:/] 

r::: 

g_ 

"' "-' 0::: 

45 

40 

35 

30 

25 

20 

15 

10 

I 

I 

/ 

' 

I 

I ' 

,' 

I 

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/ hu!lldll '\:1 L\1 

I'll< / /_/' mB:\Jl) 

__ ?h~ 

0 --c------------------/ / "-....,_~---·---

0 01 t 0 l 

!{Jl) Dose ~-~·- S\

'\

R~·

1U 

Figure Gb_ Cumukttiw Response as a timction of dose l

humans orditlCrcnt s~'nsitidti~'>. Data ar~ th~ same as in 

()a_ 

100: 

0 BQ 

> --:1.) 

..... '.f, 

..§ § 60 

::: D. § ,§ 40 

L; - 20 

l11:1:l.m '\,()\I! ,' 

.HB\I!J ",.; 

I I 

,.._. ___ l)b~· 1,_, ... ,. ... ' 

n- --·--~"Y'---

0.1 .,.~"'"" ,.,. 0 01 + 

RtD Dose 

---- .',~·rh Ill

-- ·.\;:.:r.!p

R.::-,bl

10 

27172.391

Evolution of Uncertainty Factors 

•Over the last several years, scientists have begun 

using more data when choosing uncertainty factors 

•Scientists use a nUJnber of approaches 

•Methods range fron1 default ("presumed protective") 

to those incorporating more biological data 

("biologically-based protective") 

Default Categorical Data Der

UFs Default (Compound Sp

Presumed Protective Biologically-based Protec

Meek et al, 2001 

27172.392

of Default UF: Methyl 

Oral RfD 

' Critical Effect Exgerimental Doses* 1MF RtD 1- --

1 E-4 mg

, Developmental Benchmark Dose: BMDL05 day 

neuropsychological range of 46-79 ppb in 10 I 

impairment maternal (0.00

mu/ko--

b b 

Human blood for different 

, epidemiological neurological effects in the 

, studies (Grandjean offspring at 7 years of age, 

. et al., 1997; Budtz- corresponding to a range of 

J0rgensen et al., maternal daily intakes of 

I I 999a) 0.857-1.472 

EPA, 2001 

27172.393

Dose Conversion for Methyl Hg 

d = 

c = 

b = 

v = 

A = 

f 

b\\:= 

EPA, 2001 

cxbxV 

d = (J.lg/kg/day) Ax fx bw 

daily dietary intake (expressed as of methylmerc

concentration in blood (expressed as 

elimination constant (expressed as days-1) 

volume ofblood in the body (expressed as liters) 

absorption factor (expressed as a unitless decimal fr

fi·action of absorbed dose taken up by blood (unitles

body weight (expressed in kg) 

27172.394

Example of Categorical Default 

11 Renwick (1993) proposed breaking the interspec

and intraspecies UFs into toxicokinetic (TK) and 

toxicodynamic (TO) components 

11 This approach was modified by World Health 

Organization- International Programme on Chem

Safety as follows: 

Kinetics Dynamics 

/nterspecies 

lntraspecies 

IPCS, 1994 

27172.395

Interindividual Variability in 

-Tngested MeHg 

----··--------

50111percentile" ---5oth·~-- som

Study Maternal 

Medium 

(~tg/kg-d) percentile/5111 percentil

percenti leh percent

Stern ( 1997) 1 hair 0.03-0.05d 11.8-2.4 __ ') ., ...., ""'' .)-.) . .) 

I (mean 0.04) (mean 2. 1) (mean= 2

blood 0.01 11.5-2.2 1.7-3.0 

; (mean= 1.8 (mean= 2

Swartout and hair 0.08 ! 2.2 Data not 

Rice (2000) i reported 

blood" 0.02 '2.1 2.8 

i 

Clewell et al. f' 0.08 I 1.5 1.8 ( 1999) I blood1 -- 0.07 : 1.4 1.7 

.. , 

--

--

---

, __ L. 

"Corresponding to either I ppm Hg in hair or I ppb in blood NAS, 20

27172.396

"'"' 

Kinetics Dynamics 

lnterspecies 

/ntraspecies 

Total UF = 5.8 

Methyl Hg RfD = 2 E-4 mg/kg-

27172.397

... 

0.9 

0.8 

0.7 

,q 

:g 0.6 -~ 0.. 

Ingested 

Methyl Hg 

NAS, 20

-~ 0.5 ~ cv 

:5 

E 0.4 

::::> 

CJ 

0.3 

02 

0.1 

0+-------~~~----------~----------r-----------r------

o 02 0.4 0.6 0.8 

l'v1:*-g i-"t.af<e (IJ9'l<g'day) 

Predicted mean probability of MeHg intake corresponding to 

llppm MeHg in hair. 

27172.398

Example_qf Data-Derived (or 

mpound pecific: Monte Carlo 

• Plasma Flows 

fraction of cardiac output 

ro e.g., cardiac output, brain, 

kidney, liver 

• Tissue Volumes 

s fraction of body weight 

llil e.g., body weight, brain, 

plasma, kidney 

• Partition Coefficients for 

MeHg 

m e.g., brain/blood, brain 

blood/plasma, gut/blood 

.. Kinetic Parameters 

L/hr for 1 kg animal 

e.g, conversion of bra

MeHg to inorganic Hg

MeHg to inorganic Hg 

intestine 

• Fetal Kinetic Paramet

ill L/hr 

II! placenta/embryo diffu

of MeHg, RBC to plas

diffusion on HeMg in 

27172.399

Comparison of 

ingestion rates 

Monte Carlo Deterministic 

(~g/kg/day) estimated l 0.82 0.6-0.9 (Stern, 1997) 

using a deterministic 

approach to rates 

estimated using a 

1\tlonte Carlo approach 

5 0.99 

10 1.10 

25 1.25 

50 1.5 

75 1.8 

90 2.19 

95 

3.15 

1.7 (ATSDR, lJSEPA 

MC) 

2.0 (USEPA) 

Comparison of 

Ratio of Median to 5th Percentile of Distribution Predicted Variabil

:.____~_:_:_:_~_:__--+-~-=-=-~-_::__-t--·---P--;B __ P-;~K·-------j 

ln gestio n Rate fro

1.5 Monte Carlo Anal

27172.400

2 

Distribution of RfD Values 

Percentile 

l 0.29 

5 0.]5 

10 0.38 

_) 0.44 

50 0.53 

75 0.63 

90 0.77 

95 0.86 99 1.10 

lU>tlltUUtOIIIII"I!tlltiH01HUUIUU1hi>Uo•••

·--

·-

,Q .023 

,Q 

0 

c. 

o.so 1.50 2.50 3·50 

Ingestion of Methylmercury 

Methylmercury ingestion associated 

BMDL in Seychelles population

27172.401

Summary 

• 11ited scientific ata supports use of defa

uncertainty factor for i tra-species riabil 

10. (Hg RfD = 1 E-4) 

• Newer methods on categorical defaults all

replacement of defaults with compound 

specific data. ( = 2 ~~ Monte Carlo Analysis requires more data b

allows probabilistic approach to RfD 

determination. (Hg RfD = 4 E-4) 

27172.402

jcategory Date Creditor Cred

Awards and Grants B/3/2015 US EPA 

Awards and Grants 4/6/2016 US EPA 

Awards and Grants 2/22/2017 US EPA 

Alex Malmpina:Gront 1/20/2017 Community Fdn for Greater Atlanta 

Contributions 9/25/2015 Am. Chemist 

Contributions 10/13/2015 Am Beverage Assn 

Contributions 11130/2015 TPN Assoclates,LLC 

Contributions 11/30/2015 The Coca-Colo Company 

Contributions 11/30/2015 The Coca-Colo Company 

Contributions 3/2312016 Am Beverage Asm 

Contributions 7/B/2016 Am Beverage Assn 

Contributions 7/28/2016 Society ofT oxico!ogy 

Contributions 7/22/2016 Crop life America 

Contributions 7/14/2016 Am. Chemistry Council 

Contributions 8/26/2016 The Coca·Co!a Company 

Contributions B/26/2016 The Coca-Cola Company 

Contributions 1{31/2017 The Coco-Colo Company 

Contributions 113t/2017 The Coco-Colo Company 

Corporate Sponsors 7/15/2015 Procter & Gamble Company 

Corporate Sponsors 7/31/2015 Givoudan Flavors Corporation 

Corporate Sponsors t/28/2016 Givaudan Flavors Corporation 

Corporate Sponsors 1/29/2016 Firmenich Inc 

Corporate Sponsors 1129/2016 lntertel? Scientific & Regulate 

Corporate Sponsors 111/2016 Am Beverage Assn 

Corporate Spomors 11112016 T oxStrategies Inc 

Corporate Sponsors 111/2016 The Hamner lmt for Hlth Scien 

Corporate Sponsors 1{1/2016 Novartis 

Corporate Sponsors t/1/2016 Procter & Gamble 

Corporate Sponsors 1/l/2016 Am. Chemistry Council 

Corporate Sponsors 1/112016 Exxon Mobil 

Corporate Spomon 2/23/2016 Monsanto Company 

Corporate Sponsors 2/8/2016 Mercb 

Corporate Sponsor~ 2/23/2016 The Coco-Colo Company 

Corporate Sponsors 3/9/2016 Church & Dwight Co., Inc 

Corporate Sponsors 3/9/2016 Pepsico Inc 

Corporate Sponsors 9116/2016 SRC, Inc 

Corporate Sponsors 9!23/2016 Mars Inc 

27172.403

Corporate Sponsors 1/312017 NSF lnt~rnational 

Corporate Sponsors lil0/1017 T oxStrategies, Inc 

Corporate Sponsors 1/19/2017 Exxon Mobil 

Corporate 5ponson 1/25/2017 Am. Chetni}try Council 

Corporate Sponsors 2/3/2017 lnterteR Scientific and Regula 

Corporate Sponsors 2/24/2017 Firmenich Inc 

Corporate Sponsors 3124/2017 Pepsico Inc 

Corporate Sponsors 3/212017 Mars Inc 

Corporate Sponsors 3114/2017 Procter & Gamble 

Corporate Sponsors 5/31/2017 Merch 

Corporate Spomors 5/11/2017 Givaudan Flavors Corporation 

Grants 11/30/2015 The Coca-Cola Company 

Grants 11/30/2015 The Coca-Cola Company 

Mouse Liver Tumor 12/30/2015 Exxon Mobil 

Mouse: Liver Tumor 2/29/2016 BASF 

Mou$e Liver Tumor 3/23/2016 Am Beverage Assn 

Mouse Liver Tumor 3/9/2016 The Coca~Cola Company 

Mouse Liver Tumor 3/1412016 Am. Chemistry Council 

Mouse Liver Tumor 3/21/2016 Procter & Gamb!~ 

Mouse Liver Tumor 5/lS/2016 Bayer 

Mouse Liver Tumor 717/2016 Am. Chemistry Council 

Mous~ Liver Tumor 11/9/2016 US FDA 

Mouse Liver Tumor 5/9/2017 EPA 
409 

Senator CARPER. Unfortunately, though, the bad news is that his 

answers did not alleviate my concerns about his nomination and 

his suitability to serve. 

I regret to say that my second concern with our nominees today 

before us is the nomination of Bill Wehrum, whose mom is here 

today, his wife is here today, sisters-in-law are here today, and we 

welcome you. He asked me to introduce him, and I have declined 

to do that, respectfully. I think my doing that might hurt you more 

than help you, and I don’t want to make the situation more difficult for you or for me. 

He is a Delawarean. This is a little State, and you know, in Delaware you know just about everybody. We run many races together. 

I usually have to see him run from behind. He is always running 

far ahead of me; he is a great runner. Sometimes we ride the same 

train together from Wilmington to Washington. I think he is a good 

person. I think he is a good person, but he is not, in my judgment, 

a good choice for this particular job. 

In 2005 Bill was nominated for the very same post, and I opposed his nomination then due to concerns that he deferred too frequently to industry rather than to protecting our public, public 

health. Moreover, he has suppressed scientific information and was 

not responsive to congressional requests. Mr. Wehrum’s nomination 

failed to receive Senate approval. Though unconfirmed, he served 

for 2 years as the head of the Air Office. Sadly, I fear that too little 

has changed since he last appeared before this Committee. 

I just want to take briefly—and then I will close, a look at some 

numbers. One of the numbers is 31, 31, the number of times that 

Mr. Wehrum has represented industry in lawsuits against EPA 

since 2009. Against EPA. 

Twenty-seven, the number of times that public health groups 

prevailed in court when challenging clean air regulations that Mr. 

Wehrum helped to craft at EPA because the rules didn’t follow the 

law or protect public health. Twenty-seven. 

Ten, the number of additional years that children were exposed 

to toxic power plant emissions due to regulatory delays that Mr. 

Wehrum put in place while he was at EPA. 

And one, the number of times that industry supported language 

from Mr. Wehrum’s old law firm and made it verbatim into a clean 

air regulation that he helped to write at EPA. 

As best we can tell, zero is also the number of times that Mr. 

Wehrum advocated in court for stronger clean air regulations since 

leaving the EPA, an especially troubling number for those in downwind States like Delaware. Zero is also the number of times that 

Mr. Wehrum expressed a desire to protect public health when he 

and I met prior to this hearing in my office. 

My time is short. Thank you for being generous with it, Mr. 

Chairman, but I would ask unanimous consent to submit my full 

statement for the record, including my views on the other three 

nominees before us who I hope to support. 

I look forward to hearing from all of you. Again, welcome. 

Thank you. 

[The prepared statement of Senator Carper was not received at 

time of print.] 

Senator BARRASSO. Thank you very much, Senator Carper. 

410 

Senator Inhofe. 

OPENING STATEMENT OF HON. JAMES M. INHOFE, 

U.S. SENATOR FROM THE STATE OF OKLAHOMA 

Senator INHOFE. Thank you, Mr. Chairman. I am delighted to 

join Congressman Chabot and Dunn in making introductions of 

nominees. 

I will be introducing Bill Wehrum. I am his second choice for an 

introduction. However, I am honored to do so. He has been a friend 

during the years I chaired this Committee. I just know his knowledge and expertise is second to none. His career spans more than 

31 years in the environmental field, including work as an environmental engineer, a public servant with the EPA, and an environmental lawyer. As a result, he is known across the field as an expert on the issues he will be overseeing at the EPA when he is confirmed. 

He has consistently been recognized as a leader and top lawyer 

in environmental laws for such groups as the Chambers USA, 

Legal 500 United States, and Washingtonian Magazine. Those who 

have worked with Bill praise him, like his former EPA boss, Jeff 

Holmstead, who said, ‘‘There is no better person to serve as the Assistant Administrator of the EPA’s Office of Air and Radiation.’’ 

Former EPA Deputy Administrator Marcus Peacock said, ‘‘Bill 

Wehrum, his understanding of the Clean Air Act may be second to 

none. His desire to pull up his sleeves and actually make the Clean 

Air Act work as a practical matter is second to none.’’ 

And that gets to what we are doing here. Congress and our other 

agencies should not be in the business of creating laws and regulations that are unworkable and impossible to implement, and I trust 

that Bill will be able to navigate the line between the healthy environment and ensuring standards and regulations are achievable 

and practical without undue harm to our economy, and that is the 

law, I would remind you. 

So, Mr. Wehrum, thank you for your willingness to do this tough 

job, and I look forward to many more year of service with you. 

Senator BARRASSO. Thank you, Senator Inhofe. 

We have two members of the House who have joined us today, 

Congressman Chabot from Ohio and Congressman Dunn from Florida, to introduce two of the nominees. 

I would like to welcome both of you to the Senate and invite Congressman Chabot to introduce Dr. Dourson. 

STATEMENT OF HON. STEVE J. CHABOT, 

U.S. REPRESENTATIVE FROM THE STATE OF OHIO 

Representative CHABOT. Thank you very much, Chairman Barrasso and Ranking Member Carper and all the members of this 

Committee for inviting me here today to introduce a fellow Cincinnatian, Dr. Michael Dourson. 

As everyone on the Committee is aware, Dr. Dourson has been 

nominated to be the Assistant Administrator for the EPA’s Office 

of Chemical Safety and Pollution Prevention. 

I am sure that most of you are also aware that Dr. Dourson’s impressive credentials and distinguished career, so I won’t delve into 

411 

every aspect of his resume, but I would like to mention just a few 

highlights. 

Currently, Dr. Dourson is a professor in the Risk Science Center 

at the University of Cincinnati College of Medicine, which is located in my congressional district in Cincinnati. Prior to his current position he founded and led the Center’s predecessor for 21 

years, the non-profit corporation Toxicology Excellence for Risk Assessment. And these two positions occurred following the 15 years 

Dr. Dourson worked at the U.S. EPA, where he held numerous 

leadership positions. 

Throughout his career, Dr. Dourson has served on numerous government panels and authored or co-authored an impressive array 

of publications, including more than 150 papers on risk assessment 

methods or chemical specific analyses, and over 100 government 

risk assessment documents. And he has been elected as a fellow or 

an officer for numerous professional organizations, including the 

Academy of Toxicological Sciences, the Society for Risk Analysis, 

the American Board of Toxicology, and the Society of Toxicology. 

Currently, Dr. Dourson is the President of the Toxicology Education Foundation. 

Dr. Dourson’s excellence in his field of expertise has been recognized time and time again. Over the years, he has received four 

bronze medals from the EPA, the Arnold A. Lehman Award from 

the Society of Toxicology, and the International Achievement 

Award from the International Society of Regulatory Toxicology and 

Pharmacology. 

In addition to his stellar qualifications, I would be remiss if I did 

not also mention that Dr. Dourson is a fellow graduate of La Salle 

High School. And I would also be remiss if I didn’t mention that 

La Salle has won the Ohio Division II State football championship 

the last 3 years, and we hope they win it again this year. 

Dr. Dourson, thank you for being here today, and congratulations 

on your distinguished career and this prestigious nomination. I 

wish you the best as this process moves forward, and again I want 

to thank Chairman Barrasso and Senator Carper and all the Committee members for allowing me to be here today. And if I could 

be excused, I have the parents of Otto Warmbier, who was kidnapped and brutalized by North Korea, waiting for a meeting. 

[The prepared statement of Representative Chabot follows:] 

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27172.404

Thank you, Chairman Barrasso and Ranking Member Carper, for allowing 

me to be here today to introduce a fellow Cincinnatian, Dr. Michael 

Dourson. 

As everyone on the Committee is aware, Dr. Dourson has been nominated to 

be the Assistant Administrator for the EPA's Office of Chemical Safety and 

Pollution Prevention. 

I am sure that most of you are also aware of Dr. Dourson's impressive 

credentials and distinguished career. So, I won't delve into every aspect of 

his resume, but I would like to mention a few highlights. 

Currently, Dr. Dourson is a professor in the Risk Science Center at the 

University of Cincinnati, College of Medicine, which is located in my 

district. Prior to his current position, he founded and led the Center's 

predecessor for 21 years, the nonprofit corporation, Toxicology Excellence 

for Risk Assessment (TERA). 

And these two positions occurred following the 15 years Dr. Dourson 

worked at the U.S. Environmental Protection Agency, where he held 

numerous leadership positions. 

Throughout his career, Dr. Dourson has served on numerous government 

panels and authored, or co-authored, an impressive array of publications, 

including: more than 150 papers on risk assessment methods or chemicalspecific analyses; and over 100 government risk assessment documents. 

And he has been elected as a fellow or an officer for numerous professional 

organizations, including: the Academy of Toxicological Sciences; the 

Society for Risk Analysis; the American Board of Toxicology; and the 

Society ofToxicology. Currently, Dr. Dourson is the President of the 

Toxicology Education Foundation. 

Dr. Dourson's excellence in his field of expertise has been recognized time 

and again. Over the years, he has received 4 bronze medals from EPA, the 

Arnold J. Lehman award from the Society of Toxicology, and the 

International Achievement Award from the International Society of 

Regulatory Toxicology and Pharmacology. 
413 


27172.405

In addition to his stellar qualifications, I would be remiss ifl did not also 

mention that Dr. Dourson is a fellow La Salle High School alum. Go 

Lancers! 

Dr. Dourson, thank you for being here today, and congratulations on your 

distinguished career and this prestigious nomination. I wish you the best as 

this process moves forward. 

And again thank you, Chairman Barrasso and Ranking Member Carper, for 

allowing me to be here today. 

I yield back the balance of my time. 
414 

Senator BARRASSO. Well, thank you for your time. Thank you for 

your testimony. You are certainly excused. 

Representative Dunn, welcome to the Committee, and we look 

forward to your introduction. 

STATEMENT OF HON. NEAL P. DUNN, 

U.S. REPRESENTATIVE FROM THE STATE OF FLORIDA 

Representative DUNN. Thank you very much, Chairman Barrasso, Ranking Member Carper, and members of the Committee. 

Thank you for the opportunity to introduce Matt Leopold, President 

Trump’s nominee to serve as the Assistant Administrator to the Office of General Counsel of the United States Environmental Protection Agency. 

I have the honor of serving Matt in Congress as his representative for Florida’s 2nd Congressional District. Over many years in 

public service to the State of Florida Matt has earned a reputation 

for his commitment to the rule of law and as a man of integrity. 

Matt’s record is well known to the members of this panel by now. 

He served with distinction as the General Counsel for Florida Department of Environmental Protection and is the attorney for the 

U.S. Department of Justice’s Environment and Natural Resources 

Division. Along the way, he earned the high regard of his colleagues and of the diverse group of stakeholders served by those 

institutions. 

Matt has twice been awarded the Attorney General’s Award for 

Excellence and was awarded a prestigious James Madison Institute 

Leaders Fellowship during the 2015–16 years. I also know him as 

a champion during his legal career on behalf of Florida’s coastal 

economies, particularly the oystermen and small businesses of Apalachicola, who depend on the bay for their livelihood. 

Matt is an alumnus of the University of Florida and obtained his 

JD from Florida State University College of Law, so this is perhaps 

another indicator that he is uncommonly capable of bridging diverse interests on complicated issues. 

In closing, I thank you for the opportunity to introduce a favorite 

son of Florida and a distinguished public servant to the Committee 

today. I applaud the President’s recognition of Matt’s unique qualifications for this critical role at the EPA, and I look forward to his 

continued service on behalf of our communities throughout our nation. 

Thank you very much, Mr. Chair, for the opportunity. 

[The prepared statement of Representative Dunn follows:] 

415 


27172.406

Chairman Barrasso, Ranking Member Carper 

and members of the Committee, thank you 

for the opportunity to introduce Matt 

Leopold, President Trump's nominee to 

serve as Assistant Administrator for the 

Office of General Counsel of the U.S. 

Environmental Protection Agency. 

I have the honor of serving Matt in Congress as 

the Representative of Florida's Second 

Congressional District. 

Over many years in public service to the State 

of Florida, Matt earned a reputation for his 

commitment to the rule of law and as a 

person of integrity. 
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27172.407

Matt's record is well known to the members of 

this panel by now: he served with 

distinction as General Counsel for the 

Florida Department of Environmental 

Protection and as an attorney for the for 

the U.S. Department of Justice's 

Environment and Natural Resources 

Division. Along the way, he earned the high 

regard of his colleagues and the diverse 

group stakeholders served by those 

institutions. 

Matt has twice been awarded the Attorney 

General's Award for Excellence, and was 

awarded a prestigious James Madison 

Institute Leaders Fellowship during the 

2015-2016 year. 
417 


27172.408

I also know him as a champion during his legal 

career on behalf of Florida's coastal 

economies, particularly the oystermen and 

small business in Apalach who depend on 

the bay for their livelihood. 

Matt is alumnus of the University of Florida, 

and obtained his Juris Doctorate from 

Florida State University College of Law -

perhaps another indicator that he is 

uncommonly capable of bridging interests 

on complicated issues. 
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27172.409

In closing, I thank you for the opportunity to 

introduce a favorite son of Florida and a 

distinguished public servant to the 

Committee today. 

I applaud the President's recognition of Matt's 

unique qualifications for this critical role at 

the EPA, and I look forward to his 

continued service on behalf of our 

communities. 
419 

Senator BARRASSO. Thanks very much, Congressman Dunn, and 

you are excused as well. I know you have pressing items of business elsewhere, so thank you for being with us today. 

I would like to introduce David Ross, who is the nominee for the 

Assistant Administrator of EPA’s Office of Water. Mr. Ross is a 

graduate of the University of Wisconsin-Madison and the Vermont 

Law School. He currently serves as Assistant Attorney General and 

Director of Environmental Protection Unit for the Wisconsin Department of Justice. Before that, Mr. Ross served as Wyoming’s 

Senior Assistant Attorney General in the Water and Natural Resources Division for the Wyoming Attorney General’s Office. 

Mr. Ross has a total of two decades of environmental, legal, and 

consulting experience in both the public and private sectors. His 

nomination has elicited bipartisan praise and support within my 

home State of Wyoming. 

Dave Freudenthal, the former Democrat Governor of Wyoming, 

has said ‘‘Mr. Ross’s private practice experience in DC, combined 

with his service in two State environmental protection agencies, 

make him uniquely qualified to implement America’s nuanced 

structure of Federal and State environmental protection.’’ 

Likewise, Wyoming’s current Governor, Matt Mead, Republican, 

expressed his unequivocal support for Mr. Ross, saying, ‘‘Dave is a 

talented attorney, an excellent advisor, and a person who can get 

things done. I recommend Dave without reservation for this position.’’ 

So now I would like to welcome to the Committee our nominees. 

Please take your seats. 

Congratulations to each of you. I welcome you to the Committee. 

I would like to remind each of you that your full written testimony 

will be made a part of the record. We look forward to hearing your 

testimony today. 

We will start first with Dr. Michael Dourson, and would you like 

to introduce your brother? 

STATEMENT OF MICHAEL DOURSON, PROFESSOR, RISK 

SCIENCE CENTER, DEPARTMENT OF ENVIRONMENTAL 

HEALTH, UNIVERSITY OF CINCINNATI, COLLEGE OF MEDICINE 

Mr. DOURSON. Yes. Chairman Barrasso, thank you very much. 

My brother, David Dourson, is behind me, my younger brother. 

He is a Cincinnati native and a businessman extraordinaire. So, if 

you get a chance to talk with him, I am sure he would be happy 

to speak with you. 

Senator BARRASSO. Thank you. Welcome to the Committee. Welcome as a guest, and please proceed with your testimony. 

Mr. DOURSON. Well, thank you, Chairman Barrasso, Senator 

Carper, and distinguished members of the Committee. I thank you 

for the privilege of coming before you today as a nominee for the 

position of Assistant Administrator of the Office of Chemical Safety 

and Pollution Prevention. I am honored and humbled that President Trump, Administrator Pruitt, and this Committee are considering me for this position. 

I would also like to thank my many current and former colleagues with the University of Cincinnati College of Medicine and 

420 

the independent, non-profit Toxicology Excellence for Risk Assessment, and the U.S. Environmental Protection Agency for their support and friendship. 

I also wish to thank my many friends and family, and especially 

my much better half of 39 years, Martha Dourson, who apologizes 

for not being here due to a family obligation involving grandchildren. 

I have worked on chemical safety and pollution prevention issues 

for my entire professional career as a board certified toxicologist in 

three different organizations and as an officer in one or more 

groups with five different scientific societies. The work included developing scientific positions to support the rulemaking under congressional legislation, such as the Clean Water Act, or pollution 

control prevention measures as in my role as EPA’s first leader of 

its Integrated Risk Information System, or IRIS. 

I have also served as a chair or member of well over 100 scientific peer review panels to review others’ efforts. For example, as 

chair of the panel that reviewed the nine government response to 

the World Trade disaster, or as chair of the panel that reviewed 

the government response to a West Virginia river spill and recommended lowering the existing safe dose by eightfold. We made 

it eightfold more safe. 

If confirmed as the Assistant Administrator of the Office of 

Chemical Safety and Pollution Prevention, I will dedicate my mind, 

body, and spirit to the work of this office, to working with its dedicated staff, to the protection of the American public, including its 

most vulnerable, and its environment from exposure to pesticides 

and otherwise unregulated chemicals, and to answering any and all 

of your questions and those of your constituents on chemical specific matters at any time. 

In contrast, I will not deviate in my decisions from the scientific 

principles of toxicology and risk assessment that have been taught 

to me by my mentors and co-workers, nor deviate from the code of 

ethics by my Society of Toxicology or my Society for Risk Analysis, 

nor ever stop listening to my colleagues whose expertise I do not 

have but otherwise cherish. 

As you would expect, if confirmed, I will work with my Office of 

Enforcement and Compliance Assurance colleagues in the enforcement of environmental laws that you, the representatives or our 

nation, have established. I strongly support those laws and will do 

everything in my power to assure that they are being administered 

fairly and without prejudice. 

Finally, I will strongly foster, without reservation, a collaborative 

spirit with our Federal and State colleagues, and those from other 

nations, organizations, and the public on pesticides and otherwise 

unregulated chemicals. It is through such collaboration, exemplified throughout my career with EPA, TERA, and U.C.—University 

of Cincinnati—it is through such collaboration that EPA’s practice 

of safety assessment and pollution prevention will meet the needs 

of the 21st century and will best protect the public health and the 

environment. 

Your passing of the Lautenberg Chemical Safety Act was a significant milestone, and I know it was celebrated here in Washington, but it was widely celebrated outside of Washington, DC, by 

421 

many folks. So congratulations on that. It was enabled by a bipartisan effort that included collection of diverse outside groups. If 

confirmed, nothing less should be expected of myself and the talented people of the Office of Chemical Safety and Pollution Prevention who now carry your torch. 

I appreciate the time and effort you have devoted to reviewing 

my credentials and background materials, and look forward to 

questions that you or your colleagues may have regarding this or 

related information. 

Thanks again for the opportunity to serve. 

[The prepared statement of Mr. Dourson follows:] 

422 


27172.410

Michael L. Dourson, Ph.D., DABT, FATS, FSRA 

Professor, Risk Science Center 

University of Cincinnati, College of Medicine 

Michael Dourson is a professor in the Risk Science Center at the 

University of Cincinnati, College of Medicine. He also founded and 

led the Center's predecessor of21 years, the nonprofit corporation, 

Toxicology Excellence for Risk Assessment (TERA). Prior to 

directing TERA, he worked for 15 years in the U.S. Environmental 

Protection Agency in numerous leadership positions. 

He has won several awards including 4 bronze medals from EPA, the Arnold J. Lehman 

award from the Society of Toxicology, and the International Achievement Award from 

the International Society of Regulatory Toxicology and Pharmacology. He has also been 

elected as a Fellow of the Academy of Toxicological Sciences and as a Fellow for the 

Society for Risk Analysis. 

Dr. Dourson has co-published more than 150 papers on risk assessment methods or 

chemical-specific analyses. He has co-authored well over 100 government risk 

assessment documents, many of them risk assessment guidance texts. He has made over 

150 invited presentations to a variety of organizations, and has chaired over 150 sessions 

at scientific meetings and independent peer reviews. 

He has been elected to multiple officer positions in the American Board of Toxicology 

(including its President), the Society of Toxicology (including the presidency of3 

specialty sections), the Society for Risk Analysis (including its Secretary), and is the 

President of the Toxicology Education Foundation, a nonprofit organization with a vision 

to help our public understand the essentials of toxicology. In addition to numerous 

appointments to government panels, such as EPA's Science Advisory Board, he is also a 

member on the editorial board of the peer reviewed, scientific journals Regulatory 

Toxicology and Pharmacology and Human and Experimental Toxicology. 
423 


27172.411

Statement ofMiehael L. Dourson, Ph.D., DABT, FATS, FSRA 

Nominated to be Assistant Administrator, 

Office of Chemical Safety and Pollution Prevention 

U.S. Environmental Protection Agency 

Before the Senate Environment and Public Works Committee 

September 20th, 2017 

Chairman Barrasso, Senator Carper and distinguished members of the Committee. 

thank you for the privilege of coming before you today as the nominee for the position of 

Assistant Administrator for the Office of Chemical Safety and Pollution Prevention. l am 

honored that President Trump, Administrator Pruitt and this Committee arc considering 

me for this position. 

l would also like to thank my many current and former colleagues with the 

University of Cincinnati, College of Medicine. the independent nonprofit Toxicology 

Excellence for Risk Assessment (TERA), 1 and the U.S. Environmental Protection 

Agency for their support and friendship. 

I have worked on chemical safely and pollution prevention issues for my entire 

professional career. as a board-certified toxicologist in 3 different organizations, and as 

an officer in one or more groups within 5 different scientific societies. This work 

included developing scientific positions to support rulcmaking under congressional 

legislation. such as the Clean Water Act, or pollution control/prevention measures, as in 

my role as EPA's first leader of its Integrated Risk Information System (IRIS). I have 

also served as a chair or member of well over I 00 scientific peer review panels to review 

other efforts. for example, as chair of the panel that reviewed the 9 government agencies 

1 Work for TERA was 2/3rds for government sponsors and 1/Jid for industry sponsors; 

collaborations were fostered whenever possible. 
424 


27172.412

response to the world trade disaster,2 or as chair of the panel that reviewed the 

government response to a West Virginia river spill and recommended lowering the 

existing safe dose by 8-fold.3 

If confirmed as the Assistant Administrator for OCSPP. l will dedicate my mind, 

body and spirit to the work of this office. to working with its staff, to the protection of the 

American public and its environment from overexposure to pesticides and chemicals, and 

to answering any and all of your questions and those of your constituents on chemical 

specific matters, at any time. 

In contrast, I will not deviate in my decisions from the scientific principles of 

toxicology and risk assessment that have been taught to me by my mentors and coworkers. nor deviate from the code of ethics by my Society of Toxicology or my Society 

for Risk Analysis, nor ever stop listening to my colleagues whose expertise I do not have 

but otherwise cherish. 

As you would expect. I will work with my Office of Enforcement and 

Compliance Assurance colleagues in the enforcement of environmental laws that you. the 

representatives of our nation, have established. I strongly support those laws and will do 

everything in my power to assure that they arc being administered fairly and without 

prejudice. 

Finally. I will strongly foster, without reservation, a collaborative spirit with our 

federal and state colleagues. and those from other nations, organizations and the public 

on pesticides and otherwise unregulated chemicals. It is through such collaboration that 

EPA's practice of safety assessment and pollution prevention will meet the needs of the 

2 See: http://www.tera.org/Peer:LI,:\'TC/w_~lc_pme.htm 3 See: http://www.t~l.kQ.rg/Peer/WV /WV%2Q.Expert%20~ort%20 12%20May%2020 14.pdf 

2 
425 


27172.413

21" century and will best protect public health and the environment. Your passing of the 

Lautenberg Chemical Safety Act was a signi1icant milestone enabled by a bipartisan 

effort that included collection of diverse outside groups. Nothing less should be expected 

of OCSPP. which now carries your torch. 

I appreciate the time and e!Tort you have devoted to reviewing my credentials and 

background materials. and look forward to any questions you or your colleagues may 

have regarding this. or related, information. 

3 
426 


27172.414

Senate Committee on Environment & Public Works 

Hearing entitled, "Hearing on the Nominations of Michael Dourson, Matthew Leopold, 

David Ross, and William Wehrum to be Assistant Administrators of the Environmental 

Protection Agency, and Jeffery Baran to be a Member of the Nuclear Regulatory 

Commission." 

October 4, 2017 

Questions for the Record for Mr. Michael Dourson 

Chairman Barrasso: 

I. Are you familiar with the Pesticide Registration Improvement Act (PRIA)? 

a. Do you believe the Act's provisions provide a predictable and effective evaluation 

process? 

Yes, I have some familiarity with the PRIA. My understanding is that with the 

collection of fees EPA then has the resources to complete necessary scientific 

evaluations of pesticides in a defined and predictable timeline. 

Page 1 of 42 
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27172.415

Ranking Member Carper: 

2. For decades, both Republican and Democratic administrations alike have had written policies 

limiting White House contacts with agencies that have investigatory and enforcement 

responsibilities. These policies have recognized that even a simple phone call from the 

White House to an agency inquiring about or flagging a specific matter can upset the 

evenhanded application of the law. I recently learned that Devon Energy, a strong political 

supporter of Administrator Pruitt's, informed the EPA just 5 days after Mr. Pruitt was sworn 

in as Administrator that it was no longer willing to install air pollution technology or pay a 

high penalty to EPA for its illegal air emissions of cancer-causing benzene and other 

chemicals. We also know that Trump family casinos, hotels and golf courses have been the 

subject of EPA enforcement actions for violations of the Clean Air Act and Clean Water Act. 

a. Do you agree that it is essential that in making decisions, EPA's OCSPP must be 

shielded from political influence and spared even the appearance of being subject to 

political influence or considerations? 

If confirmed, I commit to work with Administrator Pruitt and his team to ensure 

strict compliance with all legal and ethical obligations. 

b. Will you commit to restricting communications between OCSPP and the White 

House staff regarding specific matters under the authority of OCSPP? 

If confirmed, I commit to work with Administrator Pruitt and his team to ensure 

strict compliance with all legal and ethical obligations. 

c. Will you commit to ensuring the staff of OCSPP is familiar with those restrictions? 

If confirmed, I commit to work with Administrator Pruitt and his team to ensure 

strict compliance with all legal and ethical obligations. 

d. Will you commit to advising this Committee within one week if any inappropriate 

communications from White House staff to OCSPP staff, including you, occur? 

If confirmed, I commit to work with Administrator Pruitt and his team to ensure 

strict compliance with all legal and ethical obligations. 

Page 2 of42 
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27172.416

3. Recently, EPA conducted "anti-leaking" training for its employees 1

• According to EPA 

sources, the briefing stated that "Prohibitions we will discuss do not refer to 

"Whistleblowing". Agency employees have the right to make lawful disclosures to anyone, 

including, for example, management officials, the Inspector General, and/or the Office of 

Special Counsel. Employees may make disclosures to the EPA Office of the Inspector 

General through the EPA OIG Hotline at 888-546-8740." This presentation evidently failed 

to note the rights of federal employees have to make disclosures to Congress. 

5 U .S.C. § 721 l, provides that: The right of employees, individually or collectively, to 

petition Congress or a Member of Congress or to furnish information to either House of 

Congress, or to a committee or Member thereof, may not be interfered with or denied. 

Pursuant to 5 U.S.C. § 2302(b)(8), it is a violation of federal law to retaliate against 

whistleblowers. That law states: Any employee who has authority to take, direct others 

to take, recommend, or approve any personnel action, shall not, with respect to such 

authority ... take or fail to take, or threaten to take or fail to take, a personnel action with 

respect to any employee or applicant for employment because of .... (A) any disclosure of 

information by an employee or applicant which the employee or applicant reasonably 

believes evidences- (i) a violation of any law, rule, or regulation, or (ii) gross 

mismanagement, a gross waste of funds, an abuse of authority, or a substantial and 

specific danger to public health or safety, any disclosure to the Special Counsel, or to the 

Inspector General of an agency or another employee designated by the head of the agency 

to receive such disclosures, of information which the employee or applicant reasonably 

believes evidences a violation of any law, rule, or regulation ... " In addition, pursuant to 

18 U.S.C. § l 505, it is against federal law to interfere with a Congressional inquiry: 

Whoever corruptly, or by threats or force, or by any threatening letter or communication 

influences, obstructs, or impedes or endeavors to influence, obstruct, or impede the due 

and proper administration of the law under which any pending proceeding is being had 

before any department or agency ofthe United States, or the due and proper exercise of 

the power of inquiry under which any inquiry or investigation is being had by either 

House, or any committee of either House or any joint committee of the Congress. 

a. If you are confirmed, will you commit to protect the rights of all career employees in 

OCSPP to make lawful disclosures, including their right to speak with Congress? 

If confirmed, I commit to protecting the rights of OCSPP employees and will 

follow the law, 

b. Will you commit to communicate employees' whistleblower rights via email to all 

OCSPP employees within a week of being sworn in? 

If confirmed, I commit to protecting the rights of OCSPP employees and will 

follow the law. 

4. Recently, EPA decided not to revoke all the remaining tolerances for chlorpyrifos as had 

been proposed by the Obama Administration. 

1 https://www.washingtonpost.com/politics/whitehouse/federal-employees-are-ordered-to-attend-antHeakingclasses/2017 /09/21/032b40d6-9edd-lle 7-b2a7-bc70b6f98089 story.html?utm term=.e2bfc5e54d95 

Page 3 of 42 
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a. Do you believe that EPA should ever use epidemiological studies as a basis for the 

agency to conclude that it cannot make a determination that exposure to a substance 

can occur with a "reasonable certainty of no harm" under the Federal Food, Drug and 

Cosmetic Act (FFDCA)? If so, when? If not, please fully describe the reasons why 

not. 

Epidemiology studies are an important part of any risk assessment and should 

be evaluated routinely as part of any risk management decision. I believe there 

will be situations where the use of epidemiological data is appropriate. This will 

depend on the quality of the epidemiological data and the specifics of the 

determination it informs. 

b. One of the complicating factors surrounding the proposed Obama Administration's 

ban on the remaining uses of chlorpyrifos was the assertion made by some that there 

is uncertainty associated with the level of chlorpyrifos that causes an adverse health 

effect and debate about which biological endpoint should be used to define what an 

"adverse" health eftcct should be. If EPA cannot make a "reasonable certainty of no 

harm" finding under the FFDCA for a substance, how would you suggest EPA 

resolve such uncertainties in order to comply with both FFDCA and the Federal 

Insecticide, Fungicide and Rodenticide Act (Fl FRA)? 

Scientific approaches exist to help quantify and understand the impacts of 

uncertainty on a decision. If confirmed, I would use these approaches and 

would additionally seek further data and information to inform decision 

making. 

5. EPA currently uses a 10-fold safety factor to account tor the added risks mutagenic 

carcinogenic chemicals pose to vulnerable sub-populations. Will you commit to continue 

this approach? If not, please provide a specific explanation for when, why and how you 

would deviate from this approach. 

I am familiar with EPA's Supplemental Guidance for Assessing Susceptibility from 

Early-Life Exposure to Carcinogens (March, 2005). If confirmed, I commit to using 

the best available science in considering any regulatory actions that come to me for 

decision making. 

6. EPA often uses a safety adjustment factor when it writes rules that protect people from 

exposure to chemicals. That factor accounts for the interspecies variability between the effect 

of the chemical on an animal that is measured in laboratory tests and the predicted effect of 

the chemical on people. 

a. If you are confirmed, will you commit to continue to support this approach? 

Yes, when appropriate I will continue to use this approach. 

Page 4 of42 
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b. If not, how would you propose to account for interspecies differences between a 

chemical's measured effect on an animal and its predicted effect on a human? 

When sufficient data and understanding exists, physiologically based 

phannacokinetic (PBPK) models can be used to inform the differences between 

animals and humans. 

7. One argument that is often made to justify less protective chemical safety standards is to set 

an adverse effect end-point that is 'more adverse' than other end-points. For example, it 

would take higher exposure levels to a chemical for the chemical to actually cause cancer 

than it would for a biochemical marker that is a known precursor to cancer to be observed. 

Using cancer as the end-point in this scenario would allow for a less stringent safety standard 

for that chemical to be set. 

a. Generally speaking, if there is an end-point that is a precursor or otherwise predictive 

of a serious illness or risk of acute toxicity, is there ever a scenario in which EPA 

should regulate to protect against the precursor end-point rather than the more 

serious one? If so, please describe such scenarios. If not, please fully explain why 

not. 

There are scenarios where this is appropriate. It's use will depend on our 

understanding of the chemical's mechanism of action 

b. Additionally, if it is your view that safety standards should not seek to prevent effects 

that arc known to be predictive of more serious ones, please explain your views on 

whether the FDA should continue to approve cholesterol-lowering medications or 

whether it should simply focus its efforts on ways to better treat heart attacks. If you 

believe that preventive medicine should continue to be developed and approved, why 

are your views different for chemical safety standards? 

The appropriate use of safety factors is determined by available data and our 

understanding of a chemical's mode of action. I do not have an opinion on FDA 

actions. 

8. On February 28, 2017, President Trump directed EPA and the Army Corps to review and 

possibly rescind or repeal the Clean Water Rule in Executive Order 13 776. EPA recently 

ended the public comment process on the first step of a two-step process to repeal the rule 

and replace it with a rule that will protect far fewer sources of drinking water. Individuals 

with first-hand knowledge of the process EPA utilized to prepare its have informed my staff 

that: 

a) When EPA first submitted the proposed repeal rule to OMB, the draft stated that a 

the agency would undertake a new cost-benefit analysis as part of the second step 

of its process. 

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b) OMB interpreted EPA's first proposal to mean that the rule's repeal would not 

avoid any costs to industry or have any economic impact at alL EPA's political 

staffthen directed the career staffto undertake a new economic analysis. In 

response to this direction from OMB, EPA career staff reportedly changed the 

table included in the 2015 rule to i) reflect 2016 dollars instead of2014 dollars, ii) 

convert "annual costs incurred'' under the Clean Water Rule to "annual costs 

avoided" due to its repeal and iii) convert '"annual benefits gained" under the 

Clean Water Rule to "annual benefits forgone" due to its repeaL This new table 

was sent to OMB on June 8, 2017. 

c) OMB correctly concluded from EPA's June 8 submittal that repealing the rule 

would cost more in lost benefits than it would save industry in compliance costs. 

On June 13, 2017, presumably to avoid such an admission on the part of EPA, 

EPA career staffwere verbally directed by political staffto solve this 'problem' 

by simply deleting the majority of the benefits of the rule from the table andresubmitting it to OMB, which they did2 . 

The direction that was reportedly provided to the EPA career staff to make the various revisions 

to what was submitted to OMB was verbal, not written. If you are confirmed, do you commit to 

ensure that career staff in OCSPP will receive appropriately documented, rather than verbal, 

direction from political officials before they take action? If not, why not? 

I support the appropriate use of both written and oral guidance and would endeavor to use 

each in appropriate circumstances. 

9. Thank you for your response to my pre-hearing questions. I have some follow-up questions. 

In the spreadsheet you provided that listed sponsors, project description and project 

type information, there are several entities that seem incorrect. For each ofthese, 

please explain the apparent discrepancy, and if any of these entries are errors, please 

submit a corrected version of the spreadsheet in excel format: 

i. Several entries that list the American Chemistry Council as its sponsor as 

"collaborative" rather than "private sector;" 

This designation is correct. The overall project was a collaboration of 

several organizations. 

ii. Listing an entry in which the California Chamber of Commerce is the sponsor 

as "non-profit" rather than '"private sector; 

The non-profit designation is correct (see: 

h Ups:/ /www .ca lebam her .com/abo u tus/Pages/ d efa ult.aspx ). 

2 https://www.epa.gov/sites/production/files/2017-06/documents/economic analysis proposed stepl rule.pdf 

See Table 1 

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iii. Listing an entry in which the CEFIC is the sponsor as a "collaboration" rather 

than "private sector"; 

This designation is correct. The overall project was a collaboration of 

several organizations. 

iv. Listing an entry in which Concurrent Technologies Corporation is the 

sponsor as "government" rather than "private sector"; 

This designation is correct. TERA was a subcontractor to CTC who was 

working for the government. 

v. Listing an entry in which EPRI is the sponsor as a "collaboration" rather than 

"private sector"; 

This designation is correct. The overall project was a collaboration of 

several organizations. 

vi. Listing an entry in which !CL-IP is the sponsor as a "collaboration" rather 

than "private sector"; 

This designation is correct. The overall project was a collaboration of 

several organizations. 

vii. Listing an entry in which !LSI-NA is the sponsor as "non-profit" rather than 

Hprivate sector"; 

This designation is correct. ILSI is a 501(c)(3) nonprofit organization. 

viii. Listing an entry in which Lockheed Martin Corporation is the sponsor as 

"government" rather than "private sector"; 

This designation is correct. TERA was a subcontractor to Lockheed 

Martin Corporation who was working for the government. 

ix. Listing an entry in which McKenna. Long and Aldridge is the sponsor as 

"government" rather than "private sector"; 

Yes, this is a mistake. A corrected spreadsheet is attached. Thank you. 

x. Listing an entry in which Silicones Environment Safety & Health Council is 

the sponsor as "non-profit" rather than "private sector"; 

Yes, this is a mistake. A corrected spreadsheet is attached. Thank you. 

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xi. Listing an entry in which Summit Technology is the sponsor as "government" 

rather than "private sector"; 

This designation is correct. TERA was working with Summit Toxicology 

and the National Library of Medicine on this task. 

xii. Listing an entry in which ToxServices is the sponsor as "government" rather 

than ·'private sector"; 

This designation is correct. TERA was a subcontractor to ToxServices 

who was working for the government. 

xiii. Listing an entry in which the Vinyl Acetate Council is the sponsor as a 

"collaboration" rather than "private sector"; and 

This designation is correct. The overall project was a collaboration of 

several organizations. 

xiv. Listing an entry in which Waste Management is the sponsor as a 

"collaboration" rather than "private sector". 

This designation is correct. The overall project was a collaboration of 

several organizations. 

b. Please identify the "multiple sponsors" listed for each entry on this spreadsheet and 

indicate the percentage of funding received from each sponsor. 

Descriptions of all collaborative projects are a matter of public record, and can 

be found at websites associated with the Alliance for Risk Assessment (ARA) or 

Toxicology Excellence for Risk Assessment (TERA). I would be happy to direct 

your staff to the appropriate location if they have specific questions. Funding 

amounts are not specified, but sponsors who offer remuneration in excess of 2% 

ofTERA income are designated at 

http:ffwwvt.tera.orgfabout!FundingSources.html. 

c. Plea~e describe the criteria you used to designate an entity as a "non-profit," how you 

defined "sponsor" and how you defined "project ''type". 

We generally usc 50l(e)(3) designations as non profits. "Sponsors" refer to any 

group that supports the mission of Toxicology Excellence for Risk Assessment 

(TERA) whether or not they also obtain a report or opinion. "Project type" 

generally refers to whether the remuneration is from a government or other 

nonprofit, or from a private entity. 

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d. In the "Summary of billed hours" table, there is no designation for governmentsponsored work for TERA for 1995-2015. Could you provide a new table that 

includes this infonnation? 

This is possible, but would take more time than permitted in answering these 

questions, since individual records for each year would have to be reviewed. 

e. In the spreadsheet that includes this chart, you seem to have calculated the 

percentage of work done by sector by counting the number of projects you classified 

as falling under each se{;tor and dividing by the total number of projects listed. 

This is not correct. Rather, the percentage of work in the "Summary of billed 

hours" spreadsheet entitled "Question 2-TERA Yearly Funding 1995-2015" is 

based on the amount of time devoted to either nonprofit or profit areas by year. 

Time spent in the "collaborative" sector of the spreadsheet entitled "Question 3-

Project Database January 2010 to June 2015" is evenly divided into profit and 

nonprofit times of the "Question 2" spreadsheet. 

This does not reflect relative funding for projects in each sector, however. Please 

provide a detailed breakdown of the percentage oftotal funding received for projects 

included in each sector, using the corrected version of the table requested in c. 

Summaries of funding amounts per sector were not developed. 

f. In the chart, the work on the Kids+Chemical Safety website is described as: 

"Develop a kids risk webpage, in part." The project is listed as a collaborative twice, 

once with the American Chemistry Council (ACC) as the sponsor and once with the 

Combined Federal Campaign (CFC) as the sponsor. Did the CFC hire or pay TERA 

to develop the website? 

No. 

If not, what was their specific sponsorship role? 

Funding by CFC was through contributions from CFC to TERA, and TERA's 

decision to use this funding for the kids website. 

If so, how long after ACC hired TERA to develop the website did CFC contribute? 

Continuously. 

What percentage of the costs of developing the website were paid for by the CFC? 

Various funding amounts are not given per sponsoring groups. 

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Did the CFC itself fund the website, or was it donations through a CFC listing? 

Donations were through a CFC listing. 

If so, were these donations from the federal government? 

Various funding amounts are not given per sponsoring groups. However, the 

ACC contribution was the major part of the initial sponsorship. 

I 0. The following questions refer to the chart I used during the hearing (attached). For each 

chemical listed on this chart, please provide a complete description of: 

a. The year(s) in which you, TERA or other TERA employees were funded to work on 

the chemical. 

The chart below has a number of errors. Please see attachment 1. 

b. The name of the entity or entities that provided such funding, and the funding 

amount. If the activity was a collaboration, please list all collaborators as well as the 

amount of funding each collaborator contributed to the effort. 

Please see attachment 1, but note that specific funding levels arc not shown 

because summaries of this information were not developed. However, if funding 

is over 2% in any one year for any sponsor past 2010, this can be found through 

links to specific years at http://www.tcra.org/about/FundingSources.html. 

c. The type of activity (risk assessment, peer review, research paper, presentation, 

litigation support, etc) that was funded and the deliverables provided to the sponsor. 

Please see attachment 1. 

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11. Do you believe that there is a safe level of exposure to perchlorate for i) a pregnant woman, 

and ii) a toddler, with serious iodine deficiencies, and if so, what is it? Do you believe that 

there is a safe level of exposure to perchlorate for i) a pregnant woman, and ii) a toddler, who 

gets insufficient iodine according to World Health Organization guidelines, and if so, what is 

it? 

If confirmed, I will evaluate chemicals under the statutory authorities granted by 

Congress to safeguard the public. 

12. On September 21, 2017, the Consumer Product Safety Commission (CPSC) approved a 

petition3 that called for CPSC to write regulations requiring the removal of organohalogen 

flame retardants from four types of consumer products. 

a. An argument against the petition is that EPA is currently reviewing flame retardants 

under TSCA. Do you agree that EPA is currently undertaking a risk evaluation on 

only the Cyclic Aliphatic Bromide Cluster flame retardants (i.e. only one class) and 

that EPA is required by law to complete this risk evaluation and finishing a 

regulation (if needed) by November 29,2021? 

I am aware that EPA is evaluating some flame retardants. I am unclear of the 

timeline. 

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b. According to EPA's website4

, "the hexabromocyclodecanes (HBCD cluster) in the 

cyclic aliphatic bromide cluster consists of the following chemicals: 

Hexabromocyclododecane; 1,2,5,6,9, I 0-Hexabromocyclododecane; and I ,2,5,6-

Tetrabromocyclooctane. Two of these chemicals are used as flame retardants, no 

uses for 1,2,5,6-tetrabromocyclooctane have been identified. The primary use of 

the two chemicals is in expanded polystyrene foam (EPS) and extruded polystyrene 

foam (XPS) in the building and construction industry for thermal insulation boards 

and laminates for sheathing products. They are also used in plastics (additive) and 

textiles (back-coating). In the United States, the HBCD cluster was historically used 

as a flame retardant in the back coating oftextiles; however, research and 

information gathering indicates that the HBCD cluster is no longer used in consumer 

textile applications outside of the automotive industry." Do you agree that this type 

of flame retardant is generally not used in consumer products such as children's 

products, furniture, mattresses and the casings surrounding electronics? If not, why 

not? 

Beyond the details on the EPA webpage, I am not familiar with the different 

types of products that different flame retardants are used with. If confirmed, I 

can look into this. 

13. Do you agree to provide complete, accurate and timely responses to requests for information 

submitted to you by any Member of the Environment and Public Works Committee? If not, 

why not? 

Yes 

14. Before the end of the last Administration, EPA proposed to ban some uses ofthree dangerous 

chemicals using its new Toxic Substances Control Act authority. TCE is a probable 

carcinogen that is found in drinking water all across the country. Accidental exposures to 

MC, which is used in paint and furniture strippers, has killed at least 56 people since 

1980. And a second chemical used in paint strippers, NMP, is dangerous for pregnant 

women to be exposed to. Some have suggested that these bans should not be finalized, 

saying instead that EPA should study the uses of these chemicals for three more years before 

proposing a rule. Do you disagree that more exposures, more illnesses and maybe even more 

deaths would probably occur as a result of a three year delay in these proposed bans? If so, 

on what basis? If EPA has already determined that some uses of these chemicals are 

dangerous, how could one justify the extra time, taxpayer dollars and risk to human health 

that would occur by studying these same uses for three additional years instead of acting to 

finalize the bans now? 

I am not sufficiently familiar with EPA's proposed bans to respond to these questions. 

If confirmed, I will seek a briefing on the status of these proposed bans and I commit to 

evaluating all the scientific evidence to inform EPA's decision. 

4 https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaulation-cyclic-aliphatic-bromidecluster-hbcd 

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15. Recently, EPA announced that Administrator Pruitt would be publishing brief summaries of 

his calendars biweekly, after dozens of Freedom of Information Act requests for this 

information as well as a March request by me and my colleagues that he do so. During the 

Obama Administration, the Administrator, regional Administrators and all those serving in 

confirmed roles published their calendars daily'. If you are confirmed, will you commit to 

publishing your calendars daily? If not, why not? 

If confirmed, I will make my calendar available on a timely basis. 

16. Section 26 of the newly enacted TSCA states that: 

"(4) CHEMICAL SUBSTANCES WITH COMPLETED RISK ASSESSMENTS.-

With respect to a chemical substance listed in the 2014 update to the TSCA Work Plan 

for Chemical Assessments for which the Administrator has published a completed risk 

assessment prior to the date of enactment of the Frank R. Lauten berg Chemical Safety 

for the 21st Century Act, the Administrator may publish proposed and final rules under 

section 6(a) that are consistent with the scope of the completed risk assessment for the 

chemical substance and consistent with other applicable requirements of section 6." 

Page I of Attachment I is an email sent by EPA on March 17,2016, the substance ofwhich was 

shared with the bipartisan and bicameral negotiators of the Toxic Substances Control Act. It 

states that EPA "just discovered a technical issue that will have significant policy implications 

for EPA's ongoing work under Section 6. As currently drafted, both Senate and House bills 

could frustrate EPA's ability to timely manage risks that have been (or may be) identified in our 

current Work Plan risk assessments." The email goes on to describe several risk assessments on 

chemical substances (TCE, NMP, MC and 1-BP) that had been completed or were near 

completion by EPA, and stated that "EPA is not looking at all the conditions of use for these 

chemicals. This approach, which might be characterized as a partial risk evaluation or partial 

safety determination, we see as simply not contemplated under the Senate and House bills. The 

section 6 structure in both bills would require EPA to assess a chemical in its entirety, based on 

.!!!]_conditions of use- not just a subset of those uses." EPA then went on to state that if it were to 

move forward with rulemakings to restrict or ban some or all of these substances (which it has 

subsequently proposed to do), there would be some risk that the rules would be found to be 

inconsistent with the new statutory requirement to assess all conditions of use. EPA said that it 

would "welcome an opportunity to work with you on a drafting solution to this issue." 

a. Do you agree with EPA's March 17,2016 view that if it had moved forward with these 

partial risk evaluations and rulemakings absent explicit statutory authority to do so even 

though the risk evaluations had not considered all conditions of use, that EPA could have 

been sued for not complying with the law's requirements? If not. please provide specific 

reasons why not. 

If confirmed I will commit to thorough review of the final statute and would be 

happy to meet with the committee to further discuss any outstanding concerns. 

5 https://yosem ite.epa .gov I opal ad m press. nsf /Calendars ?OpenView 

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b. Pages 2 and 3 of Attachment 1 consist of April 2, 2016 Technical Assistance from EPA 

that was provided to the Senate on a drafting solution to address the problem identified 

by EPA on March 17, 2016. Do you agree that this language, which is also drafted as an 

amendment to Section 26, bears a close resemblance to the language that was enacted 

into law, and, like the enacted text, provides EPA with statutory authority to complete 

rulemakings on the chemical substances on which it completed risk assessments prior to 

the enactment of the new law even though the risk assessments were not undertaken for 

all conditions of use? If not, please provide specific reasons why not. 

If confirmed I will commit to thorough review of the final statute and would be 

happy to meet with the committee to further discuss auy outstanding concerns. 

17. The newly enacted TSCA, for new chemicals, states that: 

"(e) REGULATION PENDING DEVELOPMENT OF INFORMA TION.-(l)(A) 

If the Administrator determines that-

(i) the information available to the Administrator is insutTtcient to permit a reasoned 

evaluation of the health and environmental effects of a chemical substance with 

respect to which notice is required by subsection (a); or 

(ii)(I) in the absence of sufficient information to permit the Administrator to make 

such an evaluation, the manufacture, processing, distribution in commerce, use, or 

disposal of such substance, or any combination of such activities, may present an 

unreasonable risk of injury to health or the environment, without consideration of 

costs or other nonrisk factors, including an unreasonable risk to a potentially 

exposed or susceptible subpopulation identified as relevant by the Administrator 

under the conditions of use; or (II) such substance is or will be produced in 

substantial quantities, and such substance either enters or may reasonably be 

anticipated to enter the environment in substantial quantities or there is or may be 

significant or substantial human exposure to the substance, 

the Administrator shall issue an order, to take effect on the expiration of the 

applicable review period, to prohibit or limit the manufacture, processing, 

distribution in commerce, use, or disposal of such substance or to prohibit or limit 

any combination of such activities to the extent necessary to protect against an 

unreasonable risk of injury to health or the environment, without consideration of 

costs or other nonrisk factors, including an unreasonable risk to a potentially 

exposed or susceptible subpopulation identified as relevant by the Administrator 

under the conditions of use, and the submitter of the notice may commence 

manufacture of the chemical substance, or manufacture or processing of the 

chemical substance for a significant new use, including while any required 

information is being developed, only in compliance with the order." 

Attachment 2 consists of a portion ofEPA's Technical Assistance on an April 7, 2016 draft of 

Section 5 ofTSCA that EPA provided to the Senate. CommentA7 provides EPA's views on 

section 5(e). This comment noted a change from previous drafts, observing that the draft allowed 

manufacture of a new chemical to proceed even if EPA did not have enough information to 

determine whether it posed an unreasonable risk. This is because the draft as written allowed for 

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manufacture to proceed if EPA either took steps to obtain sufficient information about the 

chemical substance (but before it received and evaluated that information) OR if it imposed a 

risk management order. EPA also suggested some edits to this draft to restore the "functionality 

ofthe prior draft," which ensured that manufacture could not proceed unless/until the 

information about the chemical substance was sufficient and EPA made the necessary risk 

determination, or in compliance with an EPA-issued order to protect against unreasonable risk 

under the conditions of use while the information was being developed. Do you agree that the 

statute requires EPA to issue an order to protect against an unreasonable risk a new chemical 

substance may pose under the conditions of use, either while information EPA needs to assess 

the chemical substance is developed, or if EPA determines that the substance may present an 

unreasonable risk under the conditions of use, or if such substance is or will be produced in 

substantial quantities, and such substance either enters or may reasonably be anticipated to enter 

the environment in substantial quantities or there is or may be significant or substantial human 

exposure to the substance? If not, please provide specific reasons why not, using statutory text to 

explain your reasoning. 

If confirmed I will commit to thorough review of the final statute and would be 

happy to meet with the committee to further discuss auy outstanding concerns. 

18. Section 5(f)(4) ofTSCA states that: 

"(4) TREATMENT OF NONCONFORMING USES.-Not later than 90 days after 

taking an action under paragraph (2) or (3) or issuing an order under subsection (e) 

relating to a chemical substance with respect to which the Administrator has made 

a determination under subsection (a)(3)(A) or (B), the Administrator shall consider 

whether to promulgate a rule pursuant to subsection (a)(2) that identifies as a 

significant new use any manufacturing, processing, use, distribution in commerce, 

or disposal of the chemical substance that does not conform to the restrictions 

imposed by the action or order, and, as applicable, initiate such a rulemaking or 

publish a statement describing the reasons of the Administrator for not initiating 

such a rulemaking." 

Attachment 3 is an April 9, 2016 email from EPA providing responses to questions on the April 

7 draft included in Attachment 2. The email asks whether the removal of provisions 5(e)(4) and 

5(f)(l)(C) in that draft would also remove EPA's requirement to consider whether to issue a 

Significant New Use Rule (SNUR) when it issued orders to a submitter of a pre-manufacturing 

notice (PMN) (and explain its decision ifit chose not to do so). EPA responded in the 

affirmative. Do you agree that the enacted law retained the April 7 draft's requirement to 

consider whether to issue a Significant New Use Rule (SNUR) when EPA has issued an order to 

a submitter of a pre-manufacturing notice (PMN) (and explain its decision if it chooses not to do 

so)? If not, please provide specific reasons why not, using statutory text to explain your 

reasoning. 

If confirmed I will commit to thorough review oft he final statute and would be 

happy to meet with the committee to further discuss any outstanding concerns. 

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19. The newly enacted TSCA requires EPA, for existing chemicals that are designated a 

high-priority chemical substance or otherwise designated for a risk evaluation, to: 

"conduct risk evaluations pursuant to this paragraph to determine whether a 

chemical substance presents an unreasonable risk of injury to health or the 

environment, without consideration of costs or other nonrisk factors, including 

an unreasonable risk to a potentially exposed or susceptible subpopulation 

identified as relevant to the risk evaluation by the Administrator, under the 

conditions of use." 

In the statute, 'conditions of use' is defined as: 

"the circumstances, as determined by the Administrator, under which a chemical 

substance is intended, known, or reasonably foreseen to be manufactured, processed, 

distributed in commerce, used, or disposed of." 

Attachment 4 is a December 12, 2016 (post-enactment) email conveying Technical Assistance 

from EPA that responded to several questions posed about how EPA was required to do risk 

evaluations for a chemical substance under the conditions of use. Do you agree with EPA's 

responses to these questions as well as the narrative that precedes the specific responses to 

questions? If not, please provide specific reasons why not, indicating in your response how your 

views are consistent with the statutory text excerpted above (or, as applicable, how EPA's 

responses are inconsistent with the statutory text excepted above). 

If confirmed I will commit to thorough review of the final statute and would be 

happy to meet with the committee to further discuss any outstanding concerns. 

20. Attachment 5 is a document that includes EPA's technical assistance and observations that 

compared an April 12 2016 Senate draft of section 5 to an April 18, 2016 House draft. 

a. On pages 2 and 15, EPA provides comments related to the 90-day period for review 

of a PMN. Do you agree that the enacted law includes text that reflects EPA's input 

in these comments? If not, please provide specific reasons why not, using statutory 

text to explain your reasoning. 

If confirmed I will commit to thorough review of the final statute and would be 

happy to meet with the committee to further discuss any outstanding concerns. 

b. On Page 14, EPA notes the deletion of the requirement not to consider costs or other 

non-risk factors when considering section 5(h) exemption requests. Do you agree 

that the enacted law retained this deletion in this subsection, but included the 

requirement in sections 5(a), 5(e) and 5(f)? If not, please provide specific reasons 

why not, using statutory text to explain your reasoning. 

If confirmed I will commit to thorough review of the final statute and would be 

happy to meet with the committee to further discuss any outstanding concerns. 

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21. Attachment 6 consists of EPA's comments to a draft of Senate section 5 dated around April 

12,2016. 

a. EPA's comment A22 notes the absence of the requirement not to consider costs or 

other non-risk factors when considering section 5(h) exemption requests. Do you 

agree that the enacted law does not include the requirement in this subsection, but 

does include the requirement in subsections 5(a), 5(e) and 5(t)? Ifnot, please provide 

specific reasons why not, using statutory text to explain your reasoning. 

If confirmed I will commit to thorough review of the final statute and would be 

happy to meet with the committee to further discuss any outstanding concerns. 

b. Do you agree that while this same EPA comment identifies one inconsistency 

between the above-described text that is absent from subsection 5(h) but appears 

throughout the rest of section 5, it does not identij'y another difference, namely the 

presence of the term "specific uses identified in the application" in subsection 5(h) 

versus the term "conditions of use" that appears throughout the rest of section 5? If 

not, why not? 

If confirmed I will commit to thorough review of the final statute and would be 

happy to meet with the committee to further discuss any outstanding concerns. 

22. Attachment 7 consists of EPA's comments to an April3. 2016 Senate draft of section 5. 

a. On page I, EPA observes that "5( e) requires no action on the part of the 

Administrator whatsoever: it is wholly discretionary authority to impose 

requirements on the manufacture pending development of information." Do you 

agree that the enacted law requires EPA to either prohibit manufacture or issue an 

order to mitigate against potential risk while information is being developed by a 

manufacturer? If not, please provide specific reasons why not, using statutory text to 

explain your reasoning. 

If confirmed I will commit to thorough review of the final statute and would be 

happy to meet with the committee to further discuss any outstanding concerns. 

b. On page 2, EPA responds to a question posed by Senate staff. stating "We think it is 

important not to limit review to the uses identified in the notice. If the identified uses 

seem fine, and EPA therefore does nothing, the submitter is free to submit an NOC 

and then manufacture in any way he or she wants. EPA often uses 5(e) orders to 

address uses beyond those specified in notices." Do you agree that the enacted 

statute requires EPA to review the conditions of use (as that term is defined in the 

statute) of a chemical substance when it reviews a PMN as EPA advised the Senate 

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in this comment? If not, please provide specific reasons why not, using statutory text 

to explain your reasoning. 

If confirmed I will commit to thorough review of the final statute and would be 

happy to meet with the committee to further discuss any outstanding concerns. 

c. On page 9, EPA says that "It seems like the best solution, per above comment, may 

be to drop the limitation above that the order pertain only to the conditions of use 

specified in the notice." Do you agree that the enacted statute incorporated EPA's 

proposed 'best solution' and did not limit orders only to the conditions of use 

specified in the notice? If not, please provide specific reasons why not, using 

statutory text to explain your reasoning. 

If confirmed I will commit to thorough review of the final statute and would be 

happy to meet with the committee to further discuss any outstanding concerns. 

d. A second EPA comment on page 9 states that "A possible solution would be, in line 

with the Senate bill and offer, to drop (e) and require EPA to issue an order under 

what is now (f) any time EPA either makes a may present finding or lacks sufficient 

info, as necessary to make the unlikely to present finding." Do you agree that the 

enacted text retains section S(e) and also requires EPA to issue an order any time 

EPA either makes a may present finding or lacks sufficient information before 

manufacturing can commence? If not, please provide specific reasons why not, using 

statutory text to explain your reasoning. 

If confirmed I will commit to thorough review of the final statute and would be 

happy to meet with the committee to further discuss any outstanding concerns. 

e. On page 16, EPA responds to a question from Senate staff about whether, in the S(h) 

exemptions section, it makes sense to deviate from the rest of the section's references 

to 'conditions of use' and instead limit EPA's exemption determination to the uses of 

the chemical substance identified in the exemption request. EPA responds by stating 

"We agree that the reference to specific uses makes sense, but not because of 

anything having to do with a SNUR. It seems to us that, if a party is seeking a partial 

section 5 exemptions, we would consider only the uses for which they are seeking 

the exemption, since the exemption would limit them to those." Do you agree that 

the enacted statute follows EPA's advice to retain the authority for EPA to consider 

just the uses of a chemical substance included in an exemption request, but does not 

make the same limiting change anywhere else so as not to so limit its review of all 

conditions of use of a chemical substance subject to a PMN? If not, please provide 

specific reasons why not, using statutory text to explain your reasoning. 

If confirmed I will commit to thorough review of the final statute and would be 

happy to meet with the committee to further discuss any outstanding concerns. 

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23. In our private meeting, you described your work on perchlorate as an example where the 

safety standard you suggested at the time (2004) was based on older science, and said that at 

that time, you actually recommended a level that was more protective than the one industry 

was recommending. 

Yes, TERA's self-published recommendation in 2004 was 500-fold lower than the 

original safe dose proposed by industry. 

Isn't it true that in 2012, seven years after EPA recommended its drinking water reference 

dose for perchlorate, you wrote a paper6 that suggested the removal of the three-fold safety 

factor designed to protect pregnant women, which, if adopted, means the reference dose 

would be 8.6 times less protective than EPA's? 

I am not certain of the paper to which you refer. However, in 2004, I coauthored a 

paper that judged a Reference Dose (RID) to be 0.002 mg/kg-day based on infants. 

EPA later came out with a RID of 0.0007 mg/kg-day based on adults. The TERA and 

EPA RIDs are less than 3-fold apart. A comparison of the underlying information for 

these values can be found at https://toxnet.nlm.nih.gov/newtoxnet/iter.htm. 

https :1/yosem ite.epa .gov I sa b/sa bproduct. nsf /FlS F2 B 7 ES 26 BC940852 57 AD0005 302 4 F /$ Fil e/TERA+Perchlorate+W 

hite+Paper+ lZ-4-lZ.pdf 

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Senator Booker: 

24. In your statement and testimony, as well as on TERA's website, you tout the peer review and 

expert panel services you provide. Based on materials posted on TERA's website, TERA has 

in fact frequently been contracted to convene and manage peer review and expert panels on 

specific issues or specific chemicals. In the great majority of such cases, TERA has then 

appointed you to serve on the panel, most often as Chair. Established procedures for thirdparty peer reviews call for an anns-length relationship between the panel convener/manager 

and the members of the panel, to avoid conflicts of interest. How is it not a conflict of interest 

for TERA employees to appoint you, their boss, to be a member of and to chair these panels? 

When groups, including government groups, contract with TERA, they recognize that 

someone from TERA will chair and also manage the panel. TERA also ensures that any 

relationships that could create a conflict of interest or biases of panel members are 

disclosed. 

25. You also tout TERA's vetting of panelists for potential conflicts of interest. Here again, 

TERA has in virtually every case found that your serving on and chairing these panels poses 

no conflicts of interest. How do you justify having TERA employees vetting you, their boss, 

for potential conflicts of interest? 

It is not clear why I would have a conflict of interest. However, if there is a conflict of 

interest, it would always be disclosed. 

26. TERA has routinely cleared you (and in some cases other panel members) of having any 

conflicts of interest even in cases where you or other TERA employees (or other panelists) 

have conducted work for the very same companies or trade associations who are paying 

TERA to convene a particular panel? How do you justify this practice? 

I would need to understand better the specific situation you are referring to in order to 

answer this question. 

27. You state in TERA slide presentations, 'TERA follows the National Academy of Sciences 

(NAS) procedures for panel selection and conflict of interest." NAS defines a conflict of 

interest, in part, as "any financial or other interest which conflicts with the service of the 

individual because it I) could significantly impair the individual's objectivity ... The term 

'conflict of interest' means something more than individual bias ... " You have repeatedly 

served on and often chaired expert or peer review panels which TERA was paid by a 

company to convene and run. As the director of a company with a direct financial interest in 

the funding it is paid for running panels, and the possibility that future income to your 

company may be compromised if the panel makes recommendations counter to the interests 

of the company paying for the services, on what basis do you believe (and has TERA found) 

that your serving on those panels does not present a conflict of interest? 

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TERA not only follows NAS guidelines but also had a small hand in helping develop 

these same guidelines. TERA's mission is in running independent panels in part. All 

panelists are offered travel and stipend remuneration for their efforts. TERA 

employees are offered salary and travel expense (as needed). Again, EPA, NAS and 

others follow a similar practice of paying panel members. 

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Senator Capito: 

28. EPA's Safer Choice program allows companies to add a Safer Choice logo to product 

labels. The Safer Choice logo informs consumers that the product uses only safest-in-class 

ingredients. Without imposing regulations, the program has provided incentives to 

companies to formulate safer products and to develop innovative new chemistries. 

Will you support continuing this program at EPA? 

I am not familiar with the details of how this program operates. If confirmed, I will 

seek to understand it and would then be willing to have a further discussion with 

you about this program. 

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Senator Cardin: 

29. Before the end of the last Administration, EPA proposed to ban some uses of three dangerous 

chemicals using its new Toxic Substances Control Act authority. Trichloroethylene is a 

probable carcinogen that has been found in unsafe levels in household wells on Maryland's 

Eastern Shore. Accidental exposures to methylene chloride used in paint and furniture 

strippers has killed at least 56 people since 1980, including at least two Maryland residents. 

Exposure to a second chemical used in paint strippers, N-Methylpyrrolidone, is dangerous for 

pregnant women. If you are confirmed, do you commit to quickly finalize these rules and 

prohibit the uses ofthese chemicals? 

If confirmed I commit to quickly getting briefed on the status of these rules so that I can 

better understand them and the prohibitions proposed. 

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Senator Duckworth: 

30. The Environmental Protection Agency (EPA) has said that exposure to cancer-causing 

chemicals in childhood can be as much as ten times as likely to lead to cancer than the 

same exposure to the same chemical in an adult. EPA has specific policies in place to 

account for these differences when it sets safety standards for chemicals. 

You have questioned these polices claiming in your papers that, "by about 6 months of 

age, children are usually not more sensitive to chemical toxicity than adults" and "we are 

not aware of reported cases of differential harm to infants or children from low levels of 

regulated chemicals, like pesticides or food additives." This research was funded by the 

American Chemistry Council and Croplife America. 

If you are confirmed, do you commit to apply, and not to weaken, EPA's current policies 

that account for the greater sensitivity and risk children may have from chemical 

exposures? 

If confirmed, I will apply EPA policies and guidance as they are appropriate and 

consistent with today's best available scientific evidence. 

3 I. During your nomination hearing you stated that you will seek guidance from EPA ethics 

officials on whether or not you should recuse yourself from issues for which you have 

previously been engaged in. However, as a regulator you can and should use your own 

discretion on recusal. 

Yes or no, if confirmed, will you promise to recuse yourself from any agency action that 

relates to petcoke? 

I will rely on the guidance from EPA's ethics officials to determine any issues for 

which I am to be recused. 

32. As you know Administrator Pruitt, like Secretary Zinke and former Secretary Price have 

spent millions of dollars combined flying on private jets across the country. This is a gross 

waste of taxpayer dollars. 

Yes or no, as a taxpayer, do you approve of Administrator Pruitt's travel practices on the 

public dime, and will you commit to utilizing commercials flights in your position? 

If confirmed, I will commit to utilizing commercial flights whenever they are practical 

and feasible. I am not familiar with Administrator Pruitt's travel practices so I cannot 

comment on them. 

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Senator Ernst: 

33. As you know, reauthorization of the Pesticide Registration Improvement Act (PRIA), was 

passed by the House earlier this year and we have also reported it out of the Senate 

Agriculture Committee. However, even though it has broad bipartisan support, it is set to 

expire on December 8, 2017. What would be the impact to worker protection programs and 

also to the EPA if this successful program is not reauthorized? 

My understanding is that ifPRIA is not renewed, then EPA would lose a significant 

amount of funds that are currently used to conduct the daily operations, including 

pesticide reviews, in the Office of Pesticide Programs. It is also my understanding that 

significant, or perhaps all, grant funding that is used to support worker protection 

programs would no longer exist. 

34. As you know, the EPA follows a risk-based model in registration of pesticides- the gold 

standard for much of the world. How would you protect and defend the standard of riskbased rulemaking both domestically and on the international stage? 

I would protect and defend a risk based rulemaking approach by educating our 

colleagues domestically and internationally about this approach. I would do this by 

showing them how a risk based approach relies on the strength of the scientific evidence 

(including information from human studies, animal studies, and in vitro toxicological 

evaluations) to make highly informed decisions. The work conducted by the Office of 

Pesticide Programs provides many high quality examples ofrisk based evaluations. 

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Senator Fischer: 

35. After a registrant spends tens of millions of dollars (or $100-200 m) on development, many 

millions on safety data, submits often times over one hundred studies on the safety of the 

product, AND goes through FQPA rulemaking (special examination of children's risks, 

aggregate risk assessment, etc. ) - can EPA actually communicate to the public that this 

pesticide product will not result in any unreasonable effects to the environment and human 

health? The Federal Food, Drug and Cosmetic Act says food must be "safe" but EPA seems 

reluctant to say the word- how will you ensure that EPA appropriately defends Agency 

decisions? 

Whether EPA can state that the pesticide product will not result in any unreasonable 

risk to the environment and human health will depend on the results of the tests that 

are conducted. If the tests are negative, or show that effects occur at levels significantly 

higher than levels that humans and the environment are exposed to, then we should be 

able to confidently say that unreasonable effects are not expected. By using high quality 

science, and analyzing and integrating it in an objective and transparent manner I will 

ensure that EPA is able to defend its decisions. 

36. As you may know, agricultural innovation has been bottlenecked by the previous 

administration's systematic decline for proven, peer reviewed, sound science. This spring, I 

was pleased to see the EPA deny a petition to remove a safe and proven product, 

Chlorpyrifos from the market. However, more work needs to be done to provide greater 

certainty for applicators utilizing FIFRA approved products. 

I continue to be concerned about NPDES permit requirements for the application of 

pesticides in or near water. NPDES permits are duplicative and do not add any additional 

environmental protection beyond those provided through the FIFRA process. To the 

contrary, NPDES permits negatively impact the ability to protect people from mosquitoes 

that can vector the Zika Virus and other viruses like West Nile, to control invasive 

aquatic plants that contribute to flooding, impede navigation and impact public safety, 

and many other important uses. 

Dr. Dourson, should you be confirmed, will you uphold the rigorous FIFRA pesticide 

registration process and work with Congress to eliminate these costly and duplicative 

permits? 

Yes. 

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Senator Markey: 

37. Dr. Dourson, according to the EPA website, the EPA Office of Chemical Safety and 

Pollution Prevention's mission is to prevent the public and environment from potential risks 

from pesticides and toxic chemicals. Do you promise to uphold this mission and take into 

consideration all potential risks from chemical exposures when making decisions on 

protecting public health and the environment? 

Yes. 

38. Commercial and native bees and other pollinators play a key role in agriculture and natural 

ecosystems and are vital to our nation's food security, production, health, and economy. 

Pesticides, in particular insecticides, frequently kill these pollinators causing havoc for 

beekeepers and raising the alarm for environmentalists, who would like to see particular 

pesticides banned. What role do you think EPA should take in dealing with this issue that 

takes into account the various stakeholders interested in this issue? 

EPA, working with all stakeholders, should seek to understand the impact of 

insecticides on pollinators and based on the science should regulate appropriately to 

ensure protection. 

39. For over two decades, EPA has failed to perform routine consultations under the Endangered 

Species Act on regulatory actions involving pesticides. This failure has resulted in extensive 

litigation. What do you see as the problems in the consultation process and what will you do 

to fix them? 

If confirmed, I will seek to further understand the existing process and work to improve 

it with the hopes of limiting future litigation. 

40. For more than half a century, chlorpyrifos has been widely used as a pesticide on a variety of 

crops. In November 2016, the EPA released a revised human health risk assessment for 

chlorpyrifos confirming that there is no safe level of chlorpyrifos in drinking water and that 

exposure to the chemical can cause not only acute illness, but leads to many long term 

neurodevelopmental issues for children, including attention deficit, reduced IQ and damage 

to the nervous system. The 1996 Food Quality Protection Act (FPQA) requires EPA to 

protect children from unsafe exposures to pesticides and ensure with reasonable certainty that 

"no harm will result to infants and children from aggregate exposure" to pesticides. Jfthis 

standard cannot be met, the pesticide must be banned. Under court order and after years of 

delay, the EPA recently issued a decision refusing to ban the pesticide. Please explain why 

the evidence created by the EPA in its revised health assessment was not sufficient to 

conclude this issue. How will you ensure that this credible scientific evaluation is 

incorporated into any revised look at this pesticide? 

If confirmed, I will work to understand this issue completely and will ensure that all 

decisions are based on and driven by scientific evidence. 

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41. One of the most significant changes made to TSCA under the LCSA was the streamlined 

authority for EPA to require testing of chemicals by order. However, to our knowledge that 

authority has not yet been used in the 15 months since the law took effect. 

Given the importance oftesting to fill data gaps, which is critical to both prioritization and 

risk evaluation-- and fundamental to a "risk-based" system, please tell us your plans for 

using the section 4 testing authority and approach for filling data gaps for both prioritization 

and risk evaluation." 

If confirmed, I will seek to better understand the Section 4 testing authority under 

TSCA. With this knowledge, I will work to ensure that it is appropriately used to help 

fill gaps for prioritization and risk evaluation. 

42. The new law requires EPA to restrict new chemicals where the available data are insufficient 

to address their risks. How will you evaluate the adequacy of data in PMNs? What will you 

do to assure that new chemicals are adequately tested? 

I will use a weight of the evidence approach that considers all scientific evidence and 

information to evaluate PMNs. 

43. The industry has pressured EPA to accelerate the completion ofthe review period for PMNs 

in order to reduce the PMN backlog. What steps will you take to assure that EPA does not 

sacrifice the rigor and thoroughness of the review process in return for speed? 

If confirmed, I will work closely with staff to completely understand the PMN review 

process to ensure its rigor and thoroughness. 

44. EPA staff has pointed to several ways industry can improve the efficiency of the review 

process by filing more robust PMNs that anticipate and respond to the likely concerns of 

EPA reviewers. What will you do to motivate industry to file more complete and accurate 

PMNs? 

If confirmed, I will work closely with staff to completely understand the PMN process. 

It seems to me that if industry had a better understanding of the EPA evaluation 

approach, it should incentivize them to provide more complete and accurate PMN 

submissions. 

45. Do you agree that more transparency is needed so the public can understand what EPA is 

doing to protect public health and the environment in the PMN process? What specific steps 

will you take to increase transparency? 

I agree that transparency is always helpful and that the government should always 

strive to be more transparent. If confirmed, I will evaluate all the programs within 

OCSPP to ensure that they are sufficiently transparent and understood by all 

stakeholders. 

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Senator Merkley: 

46. Please summarize the identified hazards of chlorpyrifos, and any impacts chlorpyrifos has on 

the brains of developing children. 

Chlorpyrifos is an organophosphate insecticide, acaricide and miticide used primarily 

to control foliage and soil-borne insect pests on a variety of food and feed crops. 

Chlorpyrifos can cause cholinesterase inhibition in humans at high enough doses; that 

is, it can overstimulate the nervous system causing nausea, dizziness, confusion, and at 

very high exposures (e.g., accidents or major spills), respiratory paralysis and death. 

EPA has historically regulated chlorpyrifos on that endpoint. 

4 7. Please summarize the identified hazards of flame-retardants, and any links to cancer or 

endocrine disruption. 

It would be inappropriate for me to prejudge the issue, if confirmed I will ensure that 

the issue is fully and fairly considered in a publicly transparent manner that is 

consistent with EPA's statutory authorities. 

48. Please summarize the identified hazards of alachlor, and any links between alachlor and 

cancer. 

It would be inappropriate for me to prejudge the issue, if confirmed I will ensure that 

the issue is fully and fairly considered in a publicly transparent manner that is 

consistent with EPA's statutory authorities. 

49. Will you defer to EPA scientists and career staff on matters of science? 

If confirmed, as a scientist myself, I will work very closely with EPA scientists and other 

career staff to work towards consensus based on transparent, objective evaluations of 

scientific evidence. 

50. Do you believe it is important to seek balanced input from industry perspectives and 

environmental and public health perspectives? 

Yes. 

51. In a recent public disclosure of Administrator Pruitt's calendar of meetings, only about 2-3% 

of his meetings were with public health and environmental advocacy organizations, whereas 

over 25% of his meetings were with industry representatives. Do you believe this reflects 

fair and balanced input from public health and environmental advocacy organizations? 

Without knowing the number and nature of requests Administrator Pruitt received, it 

is difficult to judge if this reflects appropriate balance. 

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52. What do you think is a fair and balanced ratio of input from public health and environmental 

advocacy organizations? 

A fair and balanced ratio of input would mean accepting an equal percentage of 

meeting requests from all stakeholder groups. 

53. Will you commit to a fair and balanced ratio of input from public health and environmental 

advocacy organizations? 

Yes, to the extent that I can control this. 

54. When you and 1 met in my office, 1 asked you which chemicals you thought made sense to 

take off the market, and when asked about asbestos specifically, you said "yes". While I 

appreciate your willingness to ban asbestos in commerce, what tools could EPA use to 

address legacy exposures to asbestos under TSCA, such as exposure to asbestos already in 

many homes across the country? Will you commit to using TSCA to ban asbestos? 

Although it would be inappropriate for me to prejudge the issue, if confirmed I will 

ensure that the issue is fully and fairly considered in a publicly transparent manner 

that is consistent with EPA's statutory authorities. 

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Senator Sanders: 

Climate Change 

55. President Trump has suggested in the past that climate change is a hoax. Is the President 

correct? Is climate change a hoax? 

I believe that climate change is real and human activity contributes to climate change. 

56. Do you agree with the vast majority of scientists that the combustion of fossil fuels 

contributes to climate change? 

I believe that climate change is real and human activity contributes to climate change. 

57. After Hurricane Harvey, an Arkema Inc. chemical plant exploded due to power loss and 

flooding. The EPA recently delayed implementation of a rule that requires hazardous 

chemical facilities to improve how they assess risks and prepare for potential hazardous 

incidents. This rule also would have required certain facilities to coordinate with local 

emergency response teams to ensure readiness in the case of an industrial accident, and 

would have provided additional information to nearby residents regarding chemical hazards. 

Do you agree that communities deserve to be informed about potential chemical hazards 

from chemical facilities like the Arkema plant? If not, why not? 

I am not familiar with the existing statutes and regulations. If confirmed, I will look 

into this. 

Do you agree that this EPA rule could have helped mitigate environmental and chemical 

hazards following the Arkema plant explosion? If not, why not? 

I am not familiar with the EPA rule you are referring to. If confirmed, I will look 

into this. 

Do you agree with the decision to delay implementation of this rule? If so, why? 

I am not familiar with the EPA rule you are referring to. If confirmed, I will look 

into this. 

If confirmed, how will you work to address climate change to prevent massive toxic 

chemical exposure during and after climate-fueled super storms? 

I am not familiar with the impacts of climate-fueled super storms. If confirmed, I 

will look in to this. 

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Past Career/Conflicts of Interest 

58. The U.S. Geological Survey says that glyphosate, the active ingredient in Roundup that has 

been listed as a carcinogen by the World Health Organization, is present in 59 percent of our 

country's surface water. Recently unsealed court documents in a suit against Monsanto 

indicate that a senior EPA official colluded with Monsanto to suppress research into 

glyphosate's toxicity. 

You represented Monsanto on multiple occasions during your time at Toxicology 

Excellence for Risk Assessment. If confirmed, how will you prevent inappropriate undue 

influence from regulated industries on EPA employees? 

If confirmed, I will work with the Office of General Counsel to ensure that outside 

parties, including regulated industries do not unduly influence OCSPP. 

59. There are over 86,000 unregulated and largely untested chemicals currently in use in the 

United States. Thousands of these chemicals are being linked to negative health impactsincluding birth defects, cancer, and other problems. Given the massive funding cuts that 

President Trump has proposed for OCSPP, how do you plan to implement and enforce the 

recently updated Toxic Substances Control Act (TSCA) and expand the list of banned 

chemicals? 

I am unfamiliar with the proposed budget. 

60. As founder of the chemical consulting firm Toxicology Excellence for Risk Assessment, you 

represented Monsanto, DuPont Chemical, the Dow Chemical Company, the American 

Chemistry Council, American Cleaning Institute, and American Petroleum Institute. If 

confirmed, you will be in charge of making sure that companies like these comply with 

chemical safety regulations and conduct waste clean-ups. 

As Assistant Administrator of OCSPP, would you have any active conflicts of interests 

with these companies? If so, will you commit to recuse yourself for the full course of any 

matter in which any of your former clients is a party? lfnot, why not? ' 

If confirmed, I would work with the Office of General Counsel to ensure that I am 

avoiding any conflicts of interest. I will recuse myself based on their direction and 

advice. 

61. How does your work history of representing the chemical industry quality you to lead an 

Agency tasked with ensuring the health and safety of working people, their families, and the 

communities in which they live? 

My work history, which includes over 10 years at EPA, bas consistently focused on 

provided objective, transparent, and high quality evaluations of scientific evidence to 

inform public health. I believe this approach is fully consistent with conducting good 

science at the EPA. 

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62. Vermont has recently experienced unsafe levels ofPerfluorooctanoic acid (PFOA) in ground 

water. In 2000, the state of West Virginia hired you on DuPont Chemical's recommendation 

to determine a safe level of PFOA in drinking water. Despite clear science showing that the 

chemical's negative impacts on residents of West Virginia, you recommended safety 

standards !50 times less stringent than the maximum safety level that DuPont Chemical itself 

determined and thousands of times less stringent than the level set by the EPA in 2016. 

How and why did you come to such a radically lower standard than DuPont and the EPA 

regarding acceptable PFOA safety standards? 

The DuPont standard was understood by me at the time to be a placeholder until a 

consensus group reviewed all of the science. I was one of 10 scientists on this 

consensus group, of which 5 were from government (3 of them from EPA). The ISO 

ppb represented a consensus judgment of these IO scientists based on the best 

available information at that time. 

The PFOA safety standard you recommended turned out to be wildly inaccurate. These 

kinds of mistakes negatively impact the health of millions of people throughout the 

country. Given these kinds of mistakes and scientific inaccuracies, how will you ensure 

that standards are based on the best available science? If confirmed, will you commit to 

adhering to the science, and not necessarily the best interests of your former clients? 

If confirmed, I will ensure that EPA continues to use a systematic review approach 

that includes seeking all available scientific information, including the newest 

research, to inform objective decisions to protect public health. The scientific data 

should be the foundation of decision making in OCSPP. 

63. At the EPA, science provides the foundation for Agency policies, actions, and decisions 

made on behalfofthe American people. What should the role of science be in the 

development of the EPA policies, rules, and regulations? 

Science should be the backbone and foundation of EPA policies, rules, and regulations. 

Most Pressing Challenges 

64. In your opinion, what are the most pressing chemical safety challenges that deserve the 

attention of the EPA? If confirmed, what will you do at the EPA to address these challenges? 

The most pressing challenges within OCSPP involve I) ensuring that EPA has sufficient 

expertise to fully implement the Laufenberg amendments to TSCA in the timelines 

required by the statute and 2) ensuring that the pesticides program also has the 

expertise to meet all the pesticide registration and re-registration deadlines as required 

by PRIA. 

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65. Last year's revisions to TSCA banned states from issuing their own toxic substance 

regulations if they are more stringent than the EPA's regulations. How will you ensure states' 

rights are preserved when states like Vermont may want to protect the health of people in 

their states in a more stringent manner than the federal standards? 

If confirmed, I will seek to better understand the Lauten berg amendments to TSCA 

and will work with states to help ensure public health protection in all 50 states in a 

manner that is consistent with the law. 

Environmental Justice 

66. If confirmed, how will you address growing environmental and economic justice issues 

associated with chemical safety and pollution prevention? 

I will work with staff to make this determination if confirmed. 

67. Over 160 environmental and health groups, including the American Academy of Pediatrics, 

Breast Cancer Action, the Center for Biological Diversity, Clean Water Action, Food and 

Water Watch, Friends of the Earth, the Institute ofNeurotoxicology and Neurological 

Disorders, and Utility Workers Union of America, have raised serious concerns with your 

nomination on the grounds that you are not suited to protect individuals, families, and the 

environment from potential risks from pesticides and toxic chemicals. 

If confirmed, will you commit to working with these environmental groups and 

Americans who are threatened by toxic chemical pollution to ensure that OCSPP works 

to achieve environmental and human health? 

Yes. 

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Senator Whitehouse: 

68. Do you agree that the tobacco industry manipulated and obfuscated scientific research into the 

dangers of smoking for decades. Why or why not? 

I do not have firsthand knowledge to comment. 

69. Your name comes up over 460 times in the tobacco industry documents made public as part of 

the Tobacco Master Settlement Agreement. Some of your emails are there - corresponding 

with Phillip Morris over work they hired you to do. Even your business card and Articles of 

Incorporation for your organization TERA are there. in the files of RJ Reynolds with a 

handwritten note next to your bio that the document should be filed under 

"Consultants/Dourson." 

a. Did you provide RJ Reynolds your business card and TERA 's Articles of 

Incorporation? 

No. As I recall, and as stated in public records, our total RJ Reynolds work was 

-$85 to copy some studies from work we were doing for EPA. Phillip Morris 

work was $550. 

b. Please provide, for the record, a full accounting of the work, including the amount of 

money accepted, from whom, and the scope of work, that you did for tobacco 

companies and the role you played in the campaign to hide the truth about the dangers 

of smoking. 

TERA was not part of any campaign. Our work is a matter of public record, 

specifically a 2015 hearing of the U.S. House Committee on Science, Space, and 

Technology. Our total income from these sources is approximately $13,000. 

70. In the late 90s, TERA, the organization you founded, received funding from the Center for 

Indoor Air Research (CIAR) to study the effects of secondhand smoke. TERA' s name pops 

up throughout the tobacco database. 

a. Do you believe CIAR was a front group for the tobacco industry? Why or why not? 

I am not aware ofthis. 

b. How much money did you receive from CIAR and for what purposes? 

Approximately $6000 to study the absorption of nicotine and measure its 

breakdown products in urine. 

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c. When you undertook work for CIAR, were you aware that secondhand smoke was 

considered dangerous to your health? 

At high enough concentrations any chemical is dangerous to our health. 

Cigarette smoke is particularly worrisome. 

d. When you undertook work for CIAR, were you aware that in a December 9, 1999 

email to his colleagues, Philip Morris toxicologist Robert Elves wrote that TERA 

"may provide an alternative source for third-party verification of product stewardship 

programs besides the Chemical Manufacturers Association" (now known as the 

American Chemistry Council)? 

No. 

e. Have you done any pro bono work you've done for the tobacco industry? If so, 

please describe it. 

No. 

71. You are the co-author of a paper "Distribution of Exposure Concentrations and Doses for 

Constituents of Environmental Tobacco Smoke" that used data from the 16 Cities study to 

minimize the effects of workplace secondhand smoke. 

a. Are you aware that a 1992 EPA report identified secondhand smoke as a human 

carcinogen and the 16 Cities study was specifically conceived and designed to 

challenge this finding? 

No. 

b. When you used the data from the 16 Cities study, were you aware that its experiments 

and laboratory analyses were designed and carried out by R.J. Reynolds Tobacco 

Company scientists and that this level of involvement was not properly disclosed when 

the work was published? 

Not that I recall. 

c. The methodology used in the 16 Cities study has been criticized for inappropriately 

combining exposure data collected from workplaces that allowed smoking anywhere 

and those that allowed it only in designated areas to skew the results. Do you stand by 

the 16 Cities study methodology and data? Why or why not? 

I would have to review these criticisms before taking a stand. However, I stand 

by the work we did as part of this paper. 

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d. Your paper minimizes the impact of workplace secondhand smoke based on the 16 

Cities data. Do you stand by the findings of your report? Why or why not? 

My interpretation of this study, or at least our part ofthis study, is different than 

your question. 

e. Do you acknowledge that the 16 Cities study used data from workplaces where few 

cigarettes were observed, while characterizing these environments as "smoking," with 

the goal of diluting their estimates of workplace secondhand smoke? 

I do not know. 

f. Are you aware that recent research using 16 Cities data comes to a conclusion that 

directly contradicts the findings of both the 16 Cities study and your own? 

No. 

72. According to an analysis by Environmental Defense Fund, the journal Regulatory Toxicology 

and Pharmacology has published 37 of the 66 studies you have co-authored since 1995, 

including many for which you or TERA received financial support tram corporations and 

trade groups, including Procter & Gamble, Dow AgroSciences, and the American Chemistry 

Council. Additionally, you sit on the journal's editorial board. Regulatory Toxicology and 

Pharmacology has been widely criticized for its record of publishing industry-funded studies 

that were favorable to Big Tobacco. The journal editor, Gio Gori, has extensive ties to Big 

Tobacco. 

a. Please provide the date range(s) during which you served as the president ofTERA, 

all financial contributions received by TERA during that time, and resulting 

publications. 

I served as TERA president from February of 1995 to August 2015. A yearly 

summary of remuneration can be found in TERA's submitted 990s. Many of the 

publications and reports resulting from this work can be found at I'I'WW.tera.org, 

and related websites linked to this website. 

b. Please provide a list of all studies you've published in Regulatory Toxicology and 

Pharmacology and who financed those studies. 

Please see attachment 2. 

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c. Please provide the date range(s) for which you've been a member of Regula/01y 

Toxicology and Pharmacology's editorial board, a list of all studies you've reviewed, 

and a list of all the funding for each of those studies. 

I joined the board in the 1995. I generally review 4 manuscripts a year for this 

journal on a pro bono basis. I do not keep records of my reviews. 

d. How many studies published in Regulatory Toxicology and Pharmacology have been 

financed by the tobacco industry? 

I do not know. 

e. Do you stand by the papers published in Regulatory Toxicology and Pharmacology 

with regards to risks associated with tobacco? 

I am not aware of such papers, other than the one I coauthored. 

73. In 2002, more than 40 health experts from government, academia, and environmental groups 

wrote to the Regulatory Toxicology and Pharmacology's editors to express concern over the 

clear conflicts of interest and lack of editorial independence. Do you believe Regulatory 

Toxicology and Pharmacology is free of conflicts of interest? If not, please describe the 

conflicts of interest of which you are aware. 

Yes. As shown in Attachment 2, a large part of my papers were supported by 

governments, TERA, or the University of Cincinnati, College of Medicine. My most cited 

papers were published as an employee of EPA. However, most government work is not 

published in peer review literature. Rather, it forms the basis of government reports. 

74. The Texas Commission on Environmental Quality (TCEQ) is the primary enforcer of the Clean 

Air Act in Texas. The TCEQ gave your organization, TERA, a four-year, $600,000 contract to 

help review the agency's chemical evaluations. Two-thirds of these TCEQ analysis have made 

the guidelines less protective than they used to be. Specifically, TERA endorsed TCEQ values 

for the known carcinogens arsenic and hexavalent chromium that were much looser than those 

used in California or by the EPA. Please provide, for the record, a full accounting of the work 

you did for the TCEQ including the financial sponsors of this work? 

Generally, the work I conducted was based on more recent science or a larger set of data 

The work we did for TCEQ is a matter of public record. We had no other financial 

sponsors for the TCEQ work. 

75. Michael Honeycutt sits on the steering committee for the Alliance for Risk Assessment, which 

is an affiliate of TERA. Mr. Honeycutt also heads the toxicology division at the Texas 

Commission on Environmental Quality (TCEQ). Although you have claimed that the Alliance is 

an independent entity, you have remained on its steering committee since its inception in 2007. 

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The Alliance is sponsored by TCEQ, Georgia Pacific, and the American Petroleum Institute, to 

name a few. Yet, TERA's nonprofit tax filings don't include an)1hing on the Alliance. 

a. How can you explain the significant conflict of interest presented by Mr. Honeycutt 

routing taxpayer dollars toward a firm whose decisions Honeycutt influences? 

Dr. Honeycutt's participation on the Alliance for Risk Assessment (ARA) Steering 

Committee consists of review and endorsement of non-TCEQ projects. He recuses 

himself on TCEQ projects. The suggested Conflict oflnterest (COl) in this question 

does not exist. 

b. Can you provide a full accounting of the work conducted by the Alliance for Risk 

Assessment and its financial sponsorships? 

The ARA work and its sponsors are, and have been, publicly available. 

76. In implementing TSCA, do you believe risk management costs should be considered when 

assessing whether a chemical poses an unreasonable risk? 

The Lauten berg amendments to TSCA do not allow for the consideration of non-risk 

factors when making a finding of unreasonable risk. As such, risk management costs 

should not be considered. 

77. In implementing TSCA, EPA, consistent with congressional intent, issued a notice making it 

clear that substantiation of all non-exempt confidential business information (CBI) claims is 

required upfront. Do you commit to ensuring the EPA follows and upholds that requirement? 

Yes 

78. Pursuant to the overhauled TSCA, EPA recently published its first inventory of mercury 

supply, use, and trade in the U.S., which have very little information because it did not benefit 

from the new reporting requirements. TSCA requires that EPA promulgate a mercury and 

mercury compound reporting rule by June 22, 2018 to assist in preparation of the inventory, the 

next one of which is required to be published by April 1, 2020. 

a. Do you commit to completing the mercury and mercury compounds reporting rule by 

the June 22, 2018 deadline? 

I do not know the status of this rulemaking within the Agency. However, if 

confirmed I will work to make sure that the TSCA deadline for this rule can be 

met. 

b. Do you commit to identifying any manufacturing processes or products that 

intentionally add mercury or mercury compounds and recommend actions to achieve 

further reductions in such mercury use in the next inventory and publish that 

inventory by the April I, 2020 deadline? 

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As noted above, I do not know the status of these activities within the Agency. If 

confirmed, I will work to understand their status and to ensure that EPA is 

meeting the deadlines required by the Lauten berg amendments to TSCA. 

79. Mercury was on the 2012 Workplan Chemical List, but was removed from the list in 2014 

because EPA already knew how highly toxic mercury is, and the Agency indicated it would 

be undertaking activities to implement the Minamata Convention on Mercury 

anyway. Significantly, this action was taken well before the revised TSCA was 

enacted. Under the revised law, to facilitate meeting its Convention obligations to reduce 

mercury use in the production of switches and switches, the phase down of mercury use in 

polyurethane production, and to regulate mercury use in new products and processes, it may 

be necessary for EPA to identifY mercury among the next round of chemicals prioritized for 

action under TSCA. Will you include mercury among the next round of chemicals 

prioritized for action under TSCA as needed to further reduce mercury use in products and 

processes, and meet our obligations under the Minamata Convention? 

I am not familiar with why mercury was removed from the 2014 workplan list. If 

confirmed, I will look into this and seek to ensure that EPA is taking necessary steps to 

further reduce mercury use in products and processes. 

80. Administrator Pruitt has been criticized for spending a disproportionate amount of his time 

meeting with industry and virtually no time with public-interest groups. If confirmed, will 

you commit to meet with and listen to all parties in a balanced fashion? 

Yes. 

81. How should the EPA consider the synergistic effects of chemicals when considering approval 

of these chemicals under FIFRA? 

I am not familiar with how synergistic effects are evaluated currently in the pesticides 

program. If confirmed, I will seek to understand this to ensure that EPA's approach is 

appropriate. 

82. The Fish and Wildlife Service recently listed the rusty patched bumble bee as endangered, 

the first wild bee in the lower 48 states to receive this distinction. Pesticides were listed as 

part of the blame for the bee's current status. Other bumble bee species are also at risk due to 

increased pesticide use and other environmental challenges. How can the EPA assist in 

bettering the understanding of pesticides' role in declining bee and other pollinator species? 

If confirmed, I will make sure that the impact of pesticides on bee populations is 

appropriately evaluated. I would work to ensure that the current testing requirements 

are adequate to ensure appropriate safety. 

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83. Under your leadership, what role will EPA play in the management and control of vector 

borne illnesses like Zika? 

If confirmed, under my leadership, I will work to ensure that the Office of Pesticides 

Programs is actively engaged in reviewing the registrations of new pesticide products 

that can help decrease the spread and existence of Zika. 

84. If confirmed, do you commit to notifying the Committee of all of the email addresses you 

plan to use upon confirmation and within seven days of using a new email address, including 

any aliases or pseudonyms? Do you commit do conducting all business using official email 

addresses and other means and to refrain from any mediums that are outside the Freedom of 

Information Act's reach? 

Yes. 

85. Do you a believe that climate change is real? 

Yes. 

86. EPA Administrator Pruitt recently told CNBC that "I would not agree that [carbon dioxide's] 

a primary contributor to the global warming that we see." Based on the scientific findings 

from experts such as NOAA and statements on EPA's website, including "Carbon dioxide is 

the primary greenhouse gas that is contributing to recent climate change," Politifact 

determined that statement to be false. Do you agree with Administrator Pruitt or scientific 

experts regarding whether carbon dioxide is the primary greenhouse gas that is contributing 

to climate change? 

Climate science is outside my area of expertise and I would need further information 

before responding to this question. 

87. In 2009, as mandated by the Supreme Court and backed by a robust scientific and technical 

review, the Environmental Protection Agency produced the Endangerment and Cause or 

Contribute Findings for Greenhouse Gases (GHGs) under Section 202(a) of the Clean Air 

Act. It found six greenhouse gases- carbon dioxide, methane, nitrous oxide, 

hydrofluorocarbons, perfluorocarbons, and sulfur hexafluoride- "taken in combination 

endanger both the public health and the public welfare of current and future generations." 

Do you agree with the EPA's endangerment finding? Why or why not? 

I am not familiar with the details of EPA's endangerment finding and would need to do 

more research on the topic before answering this question. 

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88. Do you believe hydrofluorocarbons are greenhouse gases? What is the global warming 

potential of methane, and from what source does that number come? 

I am not sufficiently familiar with the definition of greenhouse gases and do not have 

the expertise to answer these questions. 

89. Do you support the amendment to the Montreal Protocol to phase down HFCs? 

I am not familiar with this aspect of the Montreal Protocol and thus cannot answer this 

question. 

90. Do you believe the U.S. should remain a party to the United Nations Framework Convention 

on Climate Change? 

Climate science is outside my area of expertise and I would need further information 

before responding to this question. 

91. Do you believe the U.S. should remain a party to the Paris Agreement? 

Climate science is outside my area of expertise and I would need further information 

before responding to this question. 

92. If confirmed, do you commit to providing complete and accurate responses to inquiries from 

EPW members in a timely fashion? 

Yes. 

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University of Cincinnati, College of Medicine--Dourson Attachment 1 

1,4-Dioxane 1 

a. 2013to2016 

b. PPG industries, Hamp and Associates, Waste Management, Toxicology 

Excellence for Risk Assessment (TERA), University of Cincinnati, College of 

Medicine, US National Toxicology Program 

c. Two publications 

• Dioxane occurs in foods (up to 15 ppb in dairy products). 

• Dioxane causes cancer at high doses, but EPA's IRIS peer review panel thought 

that a nonlinear assessment might be appropriate. 

• The State of Kentucky requested that the Alliance for Risk Assessment petition 

the government of Japan for relevant data. Four other states joined in this 

petition. Other collaborators included several consulting groups. Scientists from 

Health Canada observed. 

• This TERA/RSC work was done after EPA's IRIS document and supports the 

IRIS peer review panel's suggestion that the cancer findings are due to a 

nonlinear Mode of Action (MOA). 

• All of this information has been publicly available. 

• Health Canada is using TERA's collaborative work in their evaluation of 1,4-

dioxane. 

1-Bromopropane 2 

a. 2004 

b. Albemarle Corporation and Ameribrom, Inc 

c. A report was generated and made publicly available. 

• In 2004, occupation limits for 1-bromopropane differed by 16-fold. 

TERA critically evaluated the underlying information and recommended an OEL 

of20 ppm based on effects in newborns. 

TERA's value was lower (i.e., safer) than EPA's. 

1 Source: 

• Nishimura eta!., 2004. Study of I ,4-dioxane intake in the total diet using the market-basket 

method. Journal of Health Science 50:101-107. 

• Dourson, M; Reichard, J; Nance, P; Burleigh-Fiayer, H; Parker, A; Vincent, M; McConnell, 

EE; (2014). Mode of Action Analysis for Liver Tumors from Oral I ,4-Dioxane Exposures 

and Evidence-Based Dose Response Assessment. Reg. Toxicol. Pharmacal. Volume 68, Issue 

2_, April2014, Pages 387-401 

Michael L. Dourson, Jeri Higginbotham, Jeff Crum, Heather Burleigh-Fiayer, Patricia Nance, 

Norman D. Forsberg, Mark Lafranconi, John Reichard. 2017. Update: Mode of action 

(MOA) for liver tumors induced by oral exposure to I ,4-dioxane. Regulatory Toxicology and 

Pharmacology 88:45-55. 

• Website is currently in transfer mode. For current version see: 

http:/ /med.uc .ed u/ eh/centers/rsc/risk -resources/ara. 

2 http://www.tera.org/Publications/TI::RA %20Analysis%20of%200I::Ls%20for%20 1-

Bromopropane.pdL 

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University of Cincinnati, College of Medicine 

• An NTP study wa~ published after the TERA assessment showing cancer 

findings. 

• New evaluations based on the cancer suggested lower limits. 

PFOA-Dupont 3 

a. 2002 

b. State of West Virginia 

c. A report was generated and place on the website ofthe State of West Virginia. 

• In 2002, 4 governments and one industry recommended TERA as the independent 

and neutral party to assist in a PFOA evaluation. A West Virginia judge agreed. 

• Dr. Deanne Statts of West Virginia DEP chaired a 1O-m ember scientific panel. 

• Five panelists were government employees; 3 were from EPA. 

• The panel made a unanimous determination of a safe water level of 150 ppb. 

• All of this information has been publicly available. 

• The science of PFOA has progressed since 2002. 

Trichloroethylene (TCE) 4 

a. 2012to2016 

b. American Chemistry Council, Toxicology Excellence for Risk Assessment 

(TERA) and University of Cincinnati, College of Medicine 

c. The collaboration team had 6 conference calls, including scientists from Australia, 

3 webinars, one of which included over 400 folks, and I independent peer 

consultation. The team gave 8 presentations, and published I paper. 

• In 2012, the Alliance for Risk Assessment (ARA) was petitioned by the Alliance 

for Site Closures to review noncancer toxicity ofTCE. The Steering Committee 

oftheARA, composed primarily of government officials, asked the collaboration 

to focus instead on building range in risk values. 

• The team has had one training session with US states. 

• All of this information has been publicly available. 

Perchlorate 5 

a. 1995 to 2007 

3 Source: FINAL CA TT REPORT WITH ATTACHMENTS, AUGUST 2002 

4 Source: 

• Michael Dourson, Bernard Gadagbui, Rod Thompson, Edward Pfau, and John Lowe. 2016. 

Managing Risks ofNoncancer Health Effects at Hazardous Waste Sites: A Case Study Using 

the Reference Concentration (RfC) of Trichloroethylene (TCE). Regulatory Toxicology and 

Pharmacology 80:125-133. 

• http://med.uc.edu/eh!centers/rsc/risk-resources/ara 

5 Source: Strawson, J., Q. Zhao and M. Dourson. 2004. Reference dose for perchlorate based on 

thyroid hormone change in pregnant women as the critical effect. Reg. Tox. Pharm. 39: 44-65. 

10/12/17 2 
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University of Cincinnati, College of Medicine 

b. The Perchlorate Study Group (PPG) 

c. TERA developed a report for peer review, monitored toxicology studies and 

offered comments in peer review meetings of EPA Reference Dose (RID). 

• Afterwards EPA and the DOD disagreed on the safe dose. 

• TERA independently made its safe dose 500-fold more protective than PPG's 

original RID and published it. 

• The NAS also developed a safe dose, which was 25 times higher than EPA's, 12-

fold lower than DoD's, but within 3 fold ofTERA's value. 

Chlorpyrifos 6 

a. 2004 to 2006 

b. Dow AgroSciences 

c. Two publications 

• The science for chlorpyrifos has progressed since the time of these publications. 

• One epidemiology study shows associations of neurological effects at exposures 

lower than the current RID; other studies do not show this association. 

• Based on how chlorpyrifos works this association is not expected. 

• The raw data from this epidemiology study are not available for review. 

Alachlor and Acetochlor 7 

a. 2009-20 I 0 

b. Dow AgroSciences and Monsanto 

c. A public peer review meeting and one publication 

• Michael Dourson talked with senior US EPA leaders to determine their interest. 

EPA stated that they had developed RIDs for the parent chemicals and did not 

consider the degradates to be more toxic. 

• Dow AgroSciences and Monsanto petitioned the Alliance for Risk Assessment 

(ARA) for their review. The ARA Steering Committee endorsed a collaborative 

approach. 

• TERA formed a team of risk assessment scientists from 3 states and the EPA to 

develop these Rills. The resulting values were based on a unanimous consensus. 

6 Source: 

• Zhao, Q., B. Gadagbui and M. Dourson. 2005. Lower birth weight as a critical effect of 

Chlorpyrifos: A comparison of human and animal data. Reg. Toxicol. Phannacol. 42:55-63. 

Zhao, Q., M. Dourson and B. Gadagbui. 2006. A Review of the Reference Dose (RID) for 

Chlorpyrifos. Reg. Toxicol. Pharmacal. 44: lll-124. 

7 Source: 

• http://www .tera.orgl ART /Degradatcs/index. html; 

• Gadagbui, B; Maier, M; Dourson, M; Parker, A; Willis, A; Christopher, JP; Hicks, L; 

Ramasany, S; Roberts, SM. 2010. Derived Reference Doses (RIDs) for the Environmental 

Degradates of the Herbicides Alachlor and Acetochlor: Results of an Independent Expert 

Panel Deliberation. Regulatory Toxicology and Pharmacology 57:220-234. 

10/12/17 3 
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University of Cincinnati, College of Medicine 

Diacetyl 8 

a. 2009-20 I 0 

b. Food Producers Association 

c. One report that was made available to the public 

• At the time ofTERA's work no standards existed for worker protection. 

• TERA's standard published in 2010 (i.e., range from 70 to 200 ppb) was based on 

the best science at the time, through careful consideration of toxicology, 

epidemiology, and background exposures. 

• Subsequent analyses published by various organizations, including NIOSH, 

developed standards of 5 to 20 ppb based on different emphasis on toxicology and 

epidemiology data. 

• TERA is continuing its ongoing relationship with NIOSH since 20 I 0 through an 

Interagency Personnel Agreement Fellowship. 

Acrylamide 9 

a. 2007-1009 

b. Burger King Corporation, Frito-Lay, Inc., H.J. Heinz Company, KFC 

Corporation, McDonald's Corporation, The Proctor & Gamble Manufacturing 

Company, The Proctor & Gamble Distributing Company, and Wendy's 

International, Inc. 

c. Litigation support under proposition 65 of California, and several publications 

• TERA determined that the MOA for the most sensitive endpoint, thyroid tumors, 

was bimodal, with linear at the low dose and an acceleration of thyroid tumors 

above a threshold for hormonal action. 

• TERA 's first publication was supported by industry. 

• TERA's next two publications were in large part self-supported. 

8 Maier, AM; Kohrman-Vincent, M; Parker, A; Haber, LT. (20 I 0) Evaluation of concentrationresponse options for diacetyl in support of occupational risk assessment. Reg. Toxicol. and 

Pharmacal. 58(2): 285-296. 

9 Source: 

• Dourson, M., Hertzberg, R., Allen, B., Haber, L., Parker, A., Kroner, 0., Maier, A. and 

Kohrman, M. 2008. Evidence-Based Dose Response Assessment for Thyroid Tumorigenesis 

from Acrylamide. Regulatory Toxicology and Pharmacology 52 (2008) 264-289. 

Haber, L T; Maier, A; Kroner, OL; Kohrman, MJ. (2009) Assessment of Human Relevance 

and Mode of Action for Tunica Vaginalis Mesotheliomas Resulting from Oral Exposure to 

Acrylamide. Regul. Toxicol. Pharmacal. 53(2): 134-149. 

• Maier, A., Kohrman-Vincent, M., Hertzberg, R., Dourson, M., Haber, L.T and Allen, B. 

2012. Critical review of dose-response options for F344 rat mammary tumors for acrylamide 

Additional insights based on mode of action. Food Chern. Toxicol. 50:5, 1763-1775. 

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University of Cincinnati, College of Medicine 

• All of these publications include more findings than EPA's older IRIS document. 

10/12/17 5 
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Dourson Attachment 2 

PUBLICATIONS in Regulatory Toxicology and Pharmacology 

(funding group in brackets and refers to only funding to TERA or the 

RSC and not to contributing authors] 

1. Michael L. Dourson, Jeri Higginbotham, Jeff Crum, Heather Burleigh-Fiayer, 

Patricia Nance, Norman D. Forsberg, Mark Lafranconi, John Reichard. 2017. 

Update: Mode of action (MOA) for liver tumors induced by oral exposure to 1,4-

dioxane. Regulatory Toxicology and Pharmacology 88:45-55. [Hamp and 

Associates, Waste management, and University of Cincinnati, College of 

Medicine] 

2. Richard A. Becker, Vicki Dellarco, Jennifer Seed, Joel M. Kronenberg, Bette 

Meek, Jennifer Foreman, Christine Palermo, Chris Kirman, Igor Linkov, Rita 

Schoeny, Michael Dourson, Lynn H. Pottenger, and Mary K. Manibusan. 2017. 

Quantitative weight of evidence to assess confidence in potential modes of action. 

Regulatory Toxicology and Pharmacology, 86:205-220. [American Chemistry 

Council] 

3. Michael Dourson and Raymond G York. 2016. Advances in Assessing 

Ingredient Safety. Regulatory Toxicology and Pharmacology. 79:S 112-S 118. 

[University of Cincinnati, College of Medicine] 

4. Michael Dourson, Bernard Gadagbui, Rod Thompson, Edward Pfau, and John 

Lowe. 2016. Managing Risks ofNoncancer Health Effects at Hazardous Waste 

Sites: A Case Study Using the Reference Concentration (RfC) of 

Trichloroethylene (TCE). Regulatory Toxicology and Pharmacology 80:125-133. 

[American Chemistry Council] 

5. Ted W. Simon, Yiliang Zhu, Michael L. Dourson, Nancy B. Beck. 2016. 

Bayesian methods for uncertainty factor application for derivation of reference 

values. Regulatory Toxicology and Pharmacology 80:9-24. [American 

Chemistry Council] 

6. Dourson, M., Reichard, J., Nance, P., Burleigh-Fiayer, H., Parker, A., Vincent, 

M., McConnell, E.E. 2014. Mode of action analysis for liver tumors from oral 

1 ,4-dioxane exposures and evidence-based dose response assessment. 

Regul.Toxicol. Pharm. 68(3): 387-401. [PPG Industries] 

7. Patterson J., Maier A, Kohrman-Vincent M, and ML Dourson. 2013. Peer 

consultation on relationship between PAC profile and toxicity of petroleum 

substances. Reg. Tox and Pharm, Volume 67: S86-S93. [American Petroleum 

Institute] 
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27172.462

8. Dourson, M., Gadagbui, B., Griffin, S., Garabrant, D.H., Haws, L.C., Kirman, C. 

and Tohyama, C. 2013. The importance of problem formulations in risk 

assessment: A case study involving dioxin-contaminated soil. Reg. 

Toxicoi.Pharmcol. 66(2): 208-216. [DOW Chemical] 

9. Hasegawa R, Hirata-Koizumi M, Dourson ML, Parker A, Ono A, Hirose A. 2013. 

Safety assessment of boron by application of new uncertainty factors and their 

subdivision. Regul. Toxicol. Pharmacal. 65:1, I 08-114. [Toxicology Excellence 

for Risk Assessment] 

10. Meek, M.E., Bolger, M., Bus, J.S., Christopher, J., Conolly, R.B., Lewis, RJ., 

Paoli, G., Schoeny, R., Haber, L.T., Rosenstein A.B., Dourson, M.L. 2013. A 

Framework for Fit-for-Purpose Dose Response Assessment. ReguL ToxicoL 

PharmacaL 66(2): 234-40 (doi: 10.1016(j.yrtph 2013.03.012. [Toxicology 

Excellence for Risk Assessment] 

11. Nance P, Patterson J, Willis A, Foronda N, Dourson M. 2012. Human Health 

Risks from Mercury Exposure from Broken Compact Fluorescent Lamps. Reg. 

Tox. Pharm: 62(3): 542-552. [New Zealand Ministry of Health] 

12. Dourson, M.L., MJ. Kohrman-Vincent, B.C. Allen and W.S. Cain. 2010. Dose 

Response Assessment from Effects of Acute Exposure to Methyl Isothiocyanate 

(MITC). Reg. Toxicol. Pharmacal: 58(2): 181-188. Available on line. [Amvac 

Chemical Corporation and Taminco and Tessenderlo-Kerley] 

13. Cain, W., M. L. Dourson, M.J. Kohrman-Vincent and B.C. Allen. 2010. Human 

Chemosensory Perception ofMethyllsothiocyanage: Odor and Chemesthesi. 

Reg. Toxicol. And Pharmacal: 58(2): 173-180. Available online. [Amvac 

Chemical Corporation and Taminco and Tessenderlo-Kerley] 

14. Gadagbui, B; Maier, M; Dourson, M; Parker, A; Willis, A; Christopher, JP; 

Hicks, L; Ramasany, S; Roberts, SM. 2010. Derived Reference Doses (RIDs) for 

the Environmental Degradates of the Herbicides Alachlor and 

Acetochlor: Results of an Independent Expert Panel Deliberation. Regulatory 

Toxicology and Pharmacology 57:220-234. [Dow Agro Sciences] 

15. Hasegawa R, HK Mutsuko, ML Dourson, A Parker, LM Sweeney, A Nishikawa, 

M Yoshida, A Ono, A Hirose. 2010. Proposal of new uncertainty factor 

application to derive tolerable daily intake. Regul. Toxicol. Pharmacal. 58(2): 

237-242. [Toxicology Excellence for Risk Assessment] 

16. Dourson, M., Hertzberg, R., Allen, B., Haber, L., Parker, A., Kroner, 0., Maier, 

A. and Kohrman, M. 2008. Evidence-Based Dose Response Assessment for 

Thyroid Tumorigenesis from Acrylamide. Regulatory Toxicology and 

Pharmacology 52 (2008) 264-289. [Burger King Corporation, Frito-Lay, Inc., 

HJ. Heinz Company, KFC Corporation, McDonald's Corporation, The Proctor & 
475 


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Gamble Manufacturing Company, The Proctor & Gamble Distributing Company, 

and Wendy's International, Inc.] 

17. Hays, SM; Aylward, LL; LaKind, JS; Bartels, MJ; Barton, HA; Boogaard, PJ; 

Brunk, C; DiZio, S; Dourson, M; Goldstein, DA; Lipscomb, J; Kilpatrick, ME; 

Krewski, D; Krishnan, K; Nordberg, M; Okino, M; Tan, YM; Viau, C; Yager, 

JW. 2008. Guidelines for the derivation of Biomonitoring Equivalents: report 

from the Biomonitoring Equivalents Expert Workshop. Regul Toxicol Pharmacal. 

51 (3 Suppl):S4-15. [Toxicology Excellence for Risk Assessment] 

18. Hasegawa R, Hirata-Koizumi M, Dourson M, Parker A, Hirose A, Nakai S, 

Kamala E, Ema M. 2007. Pediatric susceptibility to 18 industrial chemicals: A 

comparative analysis of newborn with young animals. Regul Toxicol Pharmacal. 

47(3):296-307. (Risk assessment paper of the year, Society of Toxicology, Risk 

Assessment Specialty Section) [Toxicology Excellence for Risk Assessment] 

19. Zhao, Qiyu, M. Dourson and B. Gadagbui. 2006. A Review of the Reference 

Dose (RID) for Chlorpyrifos. Reg. Toxicol. Pharmacal. 44:111-124. [Dow 

AgroSciences] 

20. Dolan, D., B. Naumann, E. Sargent, A. Maier, M. Dourson. 2005. Application of 

the threshold of toxicological concern concept to pharmaceutical manufacturing 

operations. Reg. Toxicol. Pharmacal. 43: 1-9. [Toxicology Excellence for Risk 

Assessment] 

21. Fields, C., M.L. Dourson, And J. Borak. 2005. Iodine-deficient vegetarians: A 

hypothetical perchlorate-susceptible population? Reg. Tox. Pharmacal. 42(1 ):37-

46. [Toxicology Excellence for Risk Assessment] 

22. Zhao, Q., B. Gadagbui and M. Dourson. 2005. Lower birth weight as a critical 

effect of Chlorpyrifos: A comparison of human and animal data. Reg. Toxicol. 

Pharmacal. 42:55-63. [Dow AgroSciences] 

23. Strawson, J., Q. Zhao and M. Dourson. 2004. Response to Letter to the 

Editor. "Critical Effect of Perchlorate on Neonates is Iodide Uptake 

Inhibition". Reg. Tox Pharmacal. 40:378-379. [Toxicology Excellence for Risk 

Assessment] 

24. Strawson, J., Q. Zhao and M. Dourson. 2004. Reference Dose for Perchlorate 

based on Thyroid Hormone Change in Pregnant Women as the Critical 

Effect Reg. Tox. and Pharm. 39:44-65. [Toxicology Excellence for Risk 

Assessment] 

25. Dourson, M.L., G. Charnley and R. Scheuplein. 2002. Differential Sensitivity Of 

Children And Adults To Chemical Toxicity: II. Risk And 
476 


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Regulation. Regulatory Toxicology and Pharmacology. 35:448-467. [Crop Life 

America and the American Chemistry Council] 

26. Haber, L.T., A. Maier, P.R. Gentry, H.J. Clewell and M.L. 

Dourson. 2002. Genetic Polymorphisms In Assessing Jnterindividual Variability 

In Delivered Dose. Regulatory Toxicology and Pharmacology. 35:177-

197. [American Chemistry Council] 

27. Scheuplein, R., G. Charnley and M.L. Dourson. 2002. Differential Sensitivity Of 

Children and Adults To Chemical Toxicity: I. Biological Basis. Regulatory 

Toxicology and Pharmacology. 35: 429-447. [Crop Life America and the 

American Chemistry Council] 

28. Dourson, M., M. Andersen, L. Erdreich and J. Macgregor. 2001. Using Human 

Data to Protect the Public's Health. Reg. Toxicol. Pharmacal. Vol. 33, No.2, Apr 

2001, pp. 234-256. [Toxicology Excellence for Risk Assessment] 

29. Haber, L.T., L. Erdreich, G.L. Diamond, A.M. Maier, R. Ratney, Q. Zhao and 

M.L. Dourson. 2000. Hazard Identification And Dose-Response Oflnhaled 

Nickel Soluble Salts. Reg. Tox. Pharmacal. 31:210-230. [Metal Finishing 

Association of Southern California, Inc., U.S. EPA and Health Canada] 

30. Haber, L.T., G.L. Diamond, G.L. Q. Zhao, L. Erdreich and M. L. Dourson. 2000. 

Hazard Identification And Dose-Response Of Ingested Nickel Soluble Salts. Reg. 

Tox. Pharmacal. 31 :231-241. [Metal Finishing Association of Southern 

California, Inc., U.S. EPA and Health Canada] 

31. Teuschler, L.K., M.L. Dourson, W.M. Stiteler, P. Mcclure and H. 

Tully. 1999. Health risk above the reference dose for multiple chemicals. Reg. 

Toxicol. And Pharmacal. 30:S 19-S26. [Toxicology Excellence for Risk 

Assessment] 

32. Dourson, M.L., L.K. Teuschler, P.R. Durkin, and W.M. Stiteler. 1997. 

Categorical Regression of Toxicity Data: A Case Study using Aldicarb. Reg. 

Toxicol. Pharmacal. 25:121-129. [Toxicology Excellence for Risk Assessment] 

33. Felter, S.P. and M.L. Dourson. 1997. Hexavalent Chromium Contaminated Soils: 

Options for Risk Assessment and Risk Management. Reg. Tox. Pharmacal. 

25:43-59. [Maxus Corporation] 

34. Dourson, M.L., S.P. Felter, and D. Robinson. 1996. Evolution of science-based 

uncertainty factors in noncancer risk assessment. Regulatory Toxicol. Pharmacal. 

24: I 08-120. [International Life Science Institute] 
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35. Dourson, M.L. 1996. Editorial: Uncertainty Factors in Noncancer Risk 

Assessment. Reg. Tox. and Pharmacal. 24, Article No. 0115. p. 107. 

[Toxicology Excellence for Risk Assessment] 

36. Dourson, M.L. and J.M. Clark, 1990. Fish consumption advisories: Towards a 

Unified, Scientifically-credible Approach. Regulatory Toxicology and 

Pharmacology. 12:161-178. [U.S. Environmental Protection Agency] 

37. Barnes, D.G., and M.L. Dourson. 1988. Reference Dose (RID): Description and 

use in health risk assessments. Regulatory Toxicology and Pharmacology. 

8:4 71-486. [U.S. Environmental Protection Agency] 

38. Dourson, M. L. and J. F. Stara. 1983. Regulatory History and Experimental 

Support of Uncertainty Safety) Factors. Regulatory Toxicology and 

Pharmacology. 3:224-238. [U.S. Environmental Protection Agency] 
478 

Senator BARRASSO. Thank you very much, Mr. Dourson. 

Mr. Leopold. And if you would like to introduce your family, 

please go ahead, and then proceed with your testimony. 

STATEMENT OF MATTHEW LEOPOLD, COUNSEL, 

CARLTON FIELDS JORDAN BURT, P.A. 

Mr. LEOPOLD. Thank you, Mr. Chairman. With me I have today 

my wife, Kim, my daughter, Ava, my son, Zane, and my son, Luke. 

And at home with her grandparents is our 2-year-old daughter, 

Abby. And not able to be with us here today is my father, Zane, 

who couldn’t make the trip from Florida. 

Chairman Barrasso, Ranking Member Carper, distinguished 

members of the Committee, I am thankful for the privilege of being 

here before you today as the nominee for the position of General 

Counsel of the Environmental Protection Agency. I am honored 

that President Trump, Administrator Pruitt, and the members of 

this Committee are considering me for this position. 

The role of EPA’s General Counsel, overseeing the implementation of laws entrusted to the Agency, is a public trust. If I am fortunate enough to be confirmed, I would pledge to execute those duties 

with the utmost diligence and care. 

The EPA is quickly approaching its 50th birthday, and over those 

years it has already tackled some of the nation’s most pressing 

problems. When President Nixon and the Congress created the 

Agency in 1970, there were environmental issues that abounded— 

from the choking smog in Los Angeles, to toxic dumping in our 

oceans, to an infamous burning river in Ohio. The environmental 

laws passed by the Congress in the decades that followed EPA’s 

creation have been essential to securing the promise of environmental and human health protections, while at the same time allowing for economic growth and prosperity. 

There is no question that EPA has made great strides, significantly improving the quality of the air we breathe and the water 

we depend on. EPA must always continue to ensure that we don’t 

backslide from those important protections. 

To accomplish this important mission, the Federal environmental 

laws harness the strength not only of the Federal Government, but 

the resources of the States in a unique partnership known as cooperative federalism. Having served in the Florida Department of Environmental Protection, as well as the Environment and Natural 

Resources Division of the Department of Justice, I saw firsthand 

how that cooperation could yield incredible results on issues big 

and small. 

For example, the Federal-State partnership to restore America’s 

Everglades is the largest ecosystem restoration project in the world 

and has significantly improved water quality and delivery in a vast 

and rare environment, benefiting State, tribal, and Federal lands. 

On a smaller scale, I observed the State issue permits, inspect facilities, and collect air and water quality data which enabled EPA 

to better understand, manage, and ultimately prevent pollution. 

Leveraging the assets of State and Federal environmental agencies 

continues to be a key strategy for protecting and improving the environment. 

479 

On enforcement of our environmental laws, I have also seen how 

the Federal Government and States came together to address what 

has been called the greatest environmental disaster of our time, 

the Deepwater Horizon oil spill of 2010. I am proud to say that I 

played a small part in securing funding for restoration by participating in the United States civil enforcement case. 

This massive effort, led by the Department of Justice, resulted in a $20 billion settlement that has already begun flowing to Federal, 

State, and local government entities around the Gulf of Mexico. 

These funds are going largely to restore and enhance the environment, creating a once in a generation opportunity to address damages to natural resources and conserve sensitive lands in the Gulf. 

I have been engaged in environmental law and policy issues for 

my entire legal career, and for most of those years I have been in 

public service. Through that experience, I developed great respect 

for my fellow career civil servants who carry out the day to day 

work of the Federal agencies. And I think it is important for political appointees in any administration to listen to, understand, and 

collaborate with the career staff. I plan to do nothing less, should 

I have the opportunity to lead the Office of General Counsel. 

Having been in private practice, I would also emphasize to EPA 

employees the importance of listening to the regulated community 

who understand, oftentimes better than government, what it takes 

to comply with environmental regulation in the real world. 

In closing, Mr. Chairman, I again thank the President and this 

Committee for the opportunity to be here today. I would be humbled to join Administrator Pruitt to carry out EPA’s important mission. I respectfully request your support, and I look forward to any 

questions you or your colleagues may have. 

[The prepared statement of Mr. Leopold follows:] 

480 


27172.466

Matthew Leopold 

Of Counsel 

Carlton Fields 

Matthew Z. Leopold is a lawyer in Tallahassee, Florida with the law firm of 

Carlton Fields. He is the former General Counsel of the Florida Department 

of Environment Protection and a former attorney at the U.S. Department of 

Justice, Environment and Natural Resources Division. He has 10 years of 

combined federal and state government experience. Mr. Leopold's practice 

focuses exclusively on environment law, policy, and litigation. He has 

represented the state and federal governments on complex environmental litigation, including 

Florida v. Georgia, an original action in the U.S. Supreme Court, and United States v. BP 

Exploration and Production, Inc., to address the 20 l 0 Deepwater Horizon oil spill in the Gulf of 

Mexico. He also represented Florida in the long-running Everglades case working together with 

policy makers to help move forward comprehensive restoration. Mr. Leopold previously served 

as an environmental policy advisor in the Washington, DC office of Governor Jeb Bush. 
481 


27172.467

Statement of Matthew Zane Leopold 

Nominated to be Assistant Administrator, General Counsel 

U.S. Environmental Protection Agency 

Before the Senate Environment and Public Works Committee 

September 201

\ 2017 

Chairman Barrasso. Ranking Member Carper, distinguished members of the Committee. I am 

thankful for the privilege of being before you today as the nominee for the position of General 

Counsel of the Environmental Protection Agency. I am honored that President Trump. 

Administrator Pruitt. and this Committee are considering me for this position. 

I would like to begin by thanking my family who is with me here today for their tireless support 

in all my personal and professional endeavors. Behind me is my wife Kim. my daughter Ava, 

my son Zane. and my son Luke. I would also like to say hello to my two-year-old daughter 

Abby who is back in Florida with her grandparents. Finally. I'd like to recognize my father Zane 

Leopold who traveled from Florida to be here today. Thank you Dad for your many years of 

guidance and suppmt. 

The role of EPA's General CounseL overseeing the implementation of the laws entrusted to the 

agency. is a public trust. If I'm fortunate enough to be confirmed, I would pledge to execute 

those duties with the utmost diligence and care. The EPA is quickly approaching its 50th 

birthday. and over those years it has already tackled some of the nation's most pressing 

problems. When President Nixon and the Congress created the agency in 1970, there were 

environmental issues that abounded from the choking smog in Los Angeles to toxic dumping in 

our oceans to an infamous burning river in Ohio. The environmental laws passed by Congress in 
482 


27172.468

the decades that followed EPA's creation have been essential to securing the promise of 

environmental and human health protections while at the same time allowing for economic 

growth and prosperity. There is no question that EPA has made great strides, significantly 

improving the quality of the air we breathe and the waters we depend on. EPA must always 

continue to ensure that we don't backslide from those important protections. 

To accomplish this impottant mission, the federal environmental laws harness the strength not 

only of the federal government, but the resources of the states in a unique partnership known as 

"'cooperative federalism." Having served in the Florida Department of Environmental Protection 

as well as the Environment and Natural Resources Division of the Department of Justice. I saw 

firsthand how that cooperation could yield incredible results on issues big and small. For 

example. the federal-state partnership to restore America's Everglades is the largest ecosystem 

restoration project in the world and has significantly improved water quality, timing, and 

delivery in a vast and rare environment benefiting state, tribaL and federal lands. On a smaller 

scale, I observed the State issue permits, inspect facilities. and collect air and water quality data. 

which enabled EPA to better understand, manage. and ultimately prevent pollution. Leveraging 

the assets of state and federal environmental agencies continues to be a key strategy for 

protecting and improving the environment. 

On enforcement of our environmental laws. I've also seen how the federal government and the 

states came together to address what has been called the greatest environmental disaster of our 

time. the Deepwater Horizon oil spill in 2010. I'm proud to say that I played a small part in 

securing that funding by participating in the United States' civil enforcement case. This massive 

2 
483 


27172.469

etTort led by the Department of Justice, resulted in a $20-billion-dollar settlement that has 

already begun flowing to federal, state. and local government entities around the Gulf of Mexico. 

These funds are going largely to restore and enhance the environment. creating a once in a 

generation opportunity to address damages to natural resources and conserve sensitive lands 

along the Gulf Coast. 

I have heen engaged in environmental law and policy issues for my entire legal career, and for 

most ofthose years I have been in public service. Through that experience, I developed great 

respect for my fellow career civil servants who carry out the day to day work of the federal 

agencies. And I think it's important for political appointees in any administration to listen to. 

understand, and collaborate with the career staff. I plan to do nothing less should I have the 

opportunity to lead the Office of General Counsel. Having been in private practice. I also would 

emphasize to EPA employees the importance of listening to the regulated community who 

understand- often times hetter than government- what it takes to comply with environmental 

regulation in the real world. 

In closing Mr. Chairman. I again thank the President and this Committee for the opportunity to 

be here today. I would be humbled to join Administrator Pruitt to carry out EPA ·s important 

mission. I respectfully request your support. and !look forward to any questions you or your 

colleagues may have. 

3 
484 


27172.470

Senate Committee on Environment & Public Works 

Hearing entitled, "Hearing on the Nominations of Michael Dourson, Matthew Leopold, 

David Ross, and William Wehrum to be Assistant Administrators of the Environmental 

Protection Agency, and Jeffery Baran to be a Member of the Nuclear Regulatory 

Commi.fsion. " 

October 4, 2017 

Questions for the Record for Mr. Matthew Leopold 

Ranking Member Carper: 

1. For decades, both Republican and Democratic administrations alike have had written 

policies limiting White House contacts with agencies that have investigatory and 

enforcement responsibilities. These policies have recognized that even a simple phone 

call from the White House to an agency inquiring about or flagging a specific matter can 

upset the evenhanded application of the law. I recently learned that Devon Energy, a 

strong political supporter of Administrator Pruitt's, informed the EPA just 5 days after 

Mr. Pruitt was sworn in as Administrator that it was no longer willing to install air 

pollution technology or pay a high penalty to EPA for its illegal air emissions of cancercausing benzene and other chemicals. We also know that Trump family casinos, hotels 

and golf courses have been the subject of EPA enforcement actions for violations of the 

Clean Air Act and Clean Water Act. 

a. Do you agree that it is essential that in making decisions, EPA's Office of General 

Counsel (OGC) must be shielded from political influence and spared even the 

appearance of being subject to political influence or considerations? 

If confirmed, I commit to work with Administrator Pruitt and his team to ensure 

strict compliance with a illegal and ethical obligations. 

b. Will you commit to restricting communications between OGC and the White 

House staff regarding specific matters under the authority of OGC? 

If confirmed, I commit to work with Administrator Pruitt and his team to ensure 

strict compliance with a illegal and ethical obligations. 

c. Will you commit to ensuring the staff of OGC is familiar with those restrictions? 

If confirmed, I commit to work with Administrator Pruitt and his team to ensure 

strict compliance with all legal and ethical obligations. 

d. Will you commit to advising this Committee within one week if any inappropriate 

communications from White House staff to OGC staff, including you, occur? 

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27172.471

If confirmed, I commit to work with Administrator Pruitt and his team to ensure 

strict compliance with all legal and ethical obligations. 

2. Recently, EPA conducted "anti-leaking" training for its employees 1

• According to EPA 

sources, the briefing stated that "Prohibitions we will discuss do not refer to 

"Whistleblowing". Agency employees have the right to make lawful disclosures to 

anyone, including, for example, management officials, the Inspector General, and/or the 

Office of Special Counsel. Employees may make disclosures to the EPA Office of the 

Inspector General through the EPA OIG Hotline at 888-546-8740." This presentation 

evidently failed to note the rights of federal employees have to make disclosures to 

Congress. 

5 U.S.C. § 7211, provides that: The right of employees, individually or collectively, to 

petition Congress or a Member of Congress or to furnish information to either House of 

Congress, or to a committee or Member thereof, may not be interfered with or denied. 

Pursuant to 5 U.S.C. § 2302(b)(8), it is a violation of federal law to retaliate against 

whistleblowers. That law states: Any employee who has authority to take, direct others 

to take, recommend, or approve any personnel action, shall not, with respect to such 

authority ... take or fail to take, or threaten to take or fail to take, a personnel action with 

respect to any employee or applicant for employment because of .... (A) any disclosure of 

information by an employee or applicant which the employee or applicant reasonably 

believes evidences- (i) a violation of any law, rule, or regulation, or (ii) gross 

mismanagement, a gross waste of funds, an abuse of authority, or a substantial and 

specific danger to public health or safety, any disclosure to the Special Counsel, or to the 

Inspector General of an agency or another employee designated by the head of the agency 

to receive such disclosures, of information which the employee or applicant reasonably 

believes evidences a violation of any law, rule, or regulation ... " In addition, pursuant to 

18 U.S.C. § 1505, it is against federal law to interfere with a Congressional inquiry: 

Whoever corruptly, or by threats or force, or by any threatening letter or communication 

influences, obstructs, or impedes or endeavors to influence, obstruct, or impede the due 

and proper administration of the law under which any pending proceeding is being had 

before any department or agency of the United States, or the due and proper exercise of 

the power of inquiry under which any inquiry or investigation is being had by either 

House, or any committee of either House or any joint committee of the Congress. 

a. If you are confirmed, will you commit to protect the rights of all career employees 

in OGC to make lawful disclosures, including their right to speak with Congress? 

If confirmed, I commit to protecting the rights of all EPA employees and will 

follow the law. 

b. Will you commit to communicate employees' whistleblower rights via email to 

all OGC employees within a week of being sworn in? 

1 https://www.washingtonpost.com/politics/whitehouse/federal-employees-are-ordered-to-attend-anti-leakingclasses/2017/09/21/032b4Dd6-9edd-lle 7-b2a 7 -be 70b6f98089 story.html ?utm term-.e2bfc5e54d95 

Page 2 of 11 
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If confirmed, I commit to protecting the rights of all EPA employees and will 

follow the law. 

3. In the wake of Hurricane Irma, at least II deaths and numerous injuries have been 

reported in Florida due to accidental carbon monoxide poisoning from gasoline-powered 

portable generators.2 One additional death has also been reported in North Carolina, 

along with other injuries throughout the Southeastern United States.3 Many of these 

deaths and injuries could have been prevented had stronger safety standards been in place 

for portable gasoline generators. In November 2016, the U.S. Consumer Product Safety 

Commission (CPSC), following years of work on the issue, voted to issue a Notice of 

Proposed Rulemaking (NPRM) to implement a mandatory safety standard for portable 

generators.4 Since then, Administrator Pruitt and Acting CPSC Chairman Buerkle have 

separately said that section 2 I 3 ofthe Clean Air Act precludes CPSC action. 

a. Section 213 of the Clean Air Act is intended to regulate emissions from non-road 

engines or vehicles when the EPA determines that such emissions "are significant 

contributors to ozone or carbon monoxide concentrations in more than I area 

which has failed to attain the national ambient air quality standards for ozone or 

carbon monoxide." In your opinion, would the occasional indoor use of portable 

generators following a power outage be likely to be a significant contributor to 

ambient carbon monoxide concentrations in more than I area that has failed to 

attain the national ambient air quality standards for carbon monoxide? Why or 

why not? 

It would be inappropriate for me to pre_judge the outcome of a matter that 

may come before me if confirmed as General Counsel. 

b. There are currently no areas in the United States that have failed to attain the 

national ambient air quality standards for carbon monoxide, and this has been the 

case since 20105

. As a matter oflaw, could section 213 of the Clean Air Act be 

used to regulate carbon monoxide emissions due to the indoor use of portable 

generators if there are no areas in the United States that fail to attain the national 

ambient air quality standards for carbon monoxide? Why or why not? 

It would be inappropriate for me to prejudge the outcome of a matter that 

may come before me if confirmed as General Counsel. 

4. You spent more time- 6 years- as an attorney in the Environment and Natural 

Resources Division of the Department of Justice than in any other position. Based on 

your experience, to what extent do you believe that the work of the Environment and 

2 http:/lwww.miamiherald.com/news/weather/hurricane/article174097351.html http://www.sunsentin el .com/news/weather /hurricane/ sfl-carbon -man oxide-deaths-20170914-story. htm I 3 http:/lwww.charlotteobserver.com/news/article173612361.html 

4 https: /lwww. fed era I register. gov I d ocu m ents/20 16/11/21/2 016-2 696 2/safety-st and a rd-fo r-po rtabl e-gen erators 5 https: //www. epa .gov /green-book/green -book-carbon-mono xi de-19 71-a rea-inform at ion 

Page 3 of 11 
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Natural Resources Division makes an important contribution to the protection of public 

health and the environment? Please explain and describe your views of the contributions 

the work of the Division makes. 

The Environment and Natural Resources Division (ENRD) is the nation's 

environmental law firm handling work arising from approximately 150 federal civil 

and criminal statutes, including the Clean Air Act, Clean Water Act, CERCLA, and 

Safe Drinking Water Act. It serves as counsel to EPA, the Department ofthe 

Interior, and other federal agencies that have environmental or natural resource 

issues. ENRD is important to protecting human health and the environment as it 

enforces the federal pollntion-controllaws EPA oversees. 

5. Earlier this year, the fiscal year 2018 budget proposal6 submitted to Congress sought to 

eliminate the $20 million in funding the EPA provides for the Justice Department's 

Environment and Natural Resources Division. EPA has historically provided about 27 

percent ofthat offtce's budget. Based on your experience as an attorney in the 

Environment and Natural Resources Division, please describe the potential impact on the 

work of the Division of such a reduction in funding. Do you support such a reduction in 

funding? Please provide your reasoning and any information you have supporting your 

answer. Since 2005, how much funding has been provided to ENRD by EPA? How 

much money has DOJ secured through tines, penalties, and commitments to remediate 

contamination and pollution during this same time period? 

I support the important work done by ENRD. It would be inappropriate for me to 

prejudge the outcome of a matter that may come before me if confirmed as General 

Counsel. If confirmed, 1 would manage OGC's functions, including its reliance on 

ENRD as outside counsel, within the authority and budget provided by Congress. 

6. On February 28,2017, President Trump directed EPA and the Army Corps to review and 

possibly rescind or repeal the Clean Water Rule in Executive Order 13776. EPA recently 

ended the public comment process on the first step of a two-step process to repeal the rule 

and replace it with a rule that will protect far fewer sources of drinking water. 

Individuals with first-hand knowledge of the process EPA utilized to prepare its have 

informed my staff that: 

i) When EPA first submitted the proposed repeal rule to OMB, the draft stated that 

the agency would undertake a new cost-benefit analysis as part of the second step 

of its process. 

ii) OMB interpreted EPA's first proposal to mean that the rule's repeal would not 

avoid any costs to industry or have any economic impact at all. EPA's political 

staffthen directed the career staff to undertake a new economic analysis. In 

response to this direction, EPA career staff reportedly changed the table included 

in the 2015 rule to a) reflect 2016 dollars instead of2014 dollars, b) convert 

6 https: l/www. docu m entclo ud .org/ documents/ 4061910-E PA-S uperfu nd -rei mb ursem ents-to-DOJdocuments.html#document/p7 /a378119 

Page 4 of 11 
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"annual costs incurred" under the Clean Water Rule to "annual costs avoided" due 

to its repeal and c) convert "annual benefits gained" under the Clean Water Rule 

to "annual benefits forgone" due to its repeal. This new table was sent to OMB on 

June 8, 2017. 

iii) OMB correctly concluded from EPA's June 8 submittal that repealing the rule 

would cost more in lost benefits than it would save industry in compliance costs. 

On June 13,2017, presumably to avoid such an admission on the part of EPA, 

EPA career staff were verbally directed by political staff to solve this 'problem' 

by simply deleting the majority of the benefits of the rule from the table andresubmitting it to OMB, which they did7

. 

a) If the events above occurred as described to my staff, do you agree that EPA's failure 

to even attempt to undertake a credible cost-benefit analysis of its proposal to repeal 

the Clean Water Rule would be vulnerable to assertions that the agency ran afoul of 

both the Clean Water Act and the Administrative Procedure Act? Why or why not? 

I am not able to speculate about what may or may not have occurred in this 

instance. If confirmed, I would work to ensure that the legal requirements for 

analyzing the cost-benefit of EPA rules are adhered to. 

b) The direction that was reportedly provided to the EPA career staff to make the 

various revisions to what was submitted to OMB was verbal, not written. If you are 

confirmed, do you commit to ensure that career staff in OGC will receive 

appropriately documented, rather than verbal, direction from political officials before 

they take action? If not, why not? 

I support the appropriate use of both written and oral guidance and would 

endeavor to use each in appropriate circumstances. 

8. Do you agree to provide complete, accurate and timely responses to requests for 

information submitted to you by any Member of the Environment and Public Works 

Committee? If not, why not? 

Yes. 

9. Recently, EPA announced that Administrator Pruitt would be publishing brief summaries 

of his calendars biweekly, after dozens of Freedom of Information Act requests for this 

information as well as a March request by me and my colleagues that he do so. During 

the Obama Administration, the Administrator, regional Administrators and all those 

serving in confirmed roles published their calendars dailyB. If you are confirmed, will 

you commit to publishing your calendars daily? If not, why not? 

7 https://www.epa.gov/sites/production/files/2017 -06/documents/economic analysis proposed stepl rule. pdf 

See Table 1 8 https ://yosemite. epa .gov I opa/ ad mpress. nsf /Ca I end a rs ?Open View 

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If confirmed, I will make my calendar available on a timely basis. 

Senator Cardin: 

I 0. The people of Baltimore must be able to rest assured that the facilities covered by Risk 

Management Plans under CAA §112(r) will have to evaluate implementing safer 

measures protections, and that first responders will have the information they need to 

respond to chemical disasters. In your capacity as General Counsel for EPA, while facing 

a law suit from various state Attorneys General, including Attorney General Frosh of 

Maryland, how will you counsel Administrator Pruitt on the question of implementing 

the original January 2017 Environmental Protection Agency Amendments to the 

Accidental Release Prevention Requirements for Risk Management Programs under the 

Clean Air Act without further delay? 

CAA §ll2(r)(3) provides EPA the authority to amend the List of Regulated Substances. 

Would you counsel Administrator Pruitt to add chlorosulfonic acid to the List of 

Regulated Substances? 

Risk Management Plans under CAA §112(r) are an important tool provided by 

Congress for facilities using substances "known to cause or may reasonably be 

anticipated to cause death, injury, or serious adverse effects to human health or the 

environment." The plans include information on the potential effects of an 

accidental release, the steps a facility is taking to prevent such a release, and 

directions for those that respond if a release occurs. I am unfamiliar with the 

specific legal issues raised in the litigation referenced. Also, it would be 

inappropriate for me to prejudge the outcome of a matter that may come before me 

if confirmed as General Counsel. If confirmed, I would request a briefing by EPA 

staff on the issues and EPA legal authorities. 

II. Attorney General Jeff Sessions issued a memo on June 7, 2017, prohibiting all 

Department of Justice components and United States Attorney's Offices from entering 

into any settlement agreement that directs or provides for a settlement payment to nongovernmental, third parties that were not directly harmed by the conduct. As you know, 

this is commonplace practice in cases where the environmental harm is irreparable-like 

the BP oil spill or the Volkswagen diesel emissions case. Please provide your 

understanding of the legal basis, if any, for prohibiting payments to third parties that will 

mitigate environmental harms? 

The Department of Justice has certain legal authority to conduct and settle litigation 

matters. In litigation matters where the Department of Justice is counsel to EPA, I 

would respect the legal authority of the Department as appropriate. 

Senator Markey: 

12. In the past, you stated that the EPA was regulating beyond its authority in terms of the 

Clean Power Plan, however you also said that it's "settled law EPA can regulate 

Page 6 of 11 
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greenhouse gases." Given this and the intentions of the EPA to repeal the CPP, what 

suggestions would you make to Administrator Pruitt in terms of the Plan's replacement? 

It would be inappropriate for me to prejudge the outcome of a matter that may 

come before me if confirmed as General Counsel. If confirmed, I would request a 

briefing by EPA staff on the issues and EPA legal authorities, and I would 

commit to offer counsel supporting the rule of law in this or any other EPA action. 

Senator Sanders: 

Climate Change 

13. President Trump has suggested in the past that climate change is a hoax. Is the President 

correct? Is climate change a hoax? 

I believe that climate change is real and human activity contributes to climate 

change. 

I 4. Do you agree with the vast majority of scientists that climate change is real, it is caused 

by human activity, and that we must aggressively transition away from fossil fuels and 

toward energy efficiency and sustainable energy like wind, solar, and geothermal? 

I believe that climate change is real and human activity contributes to climate 

change. 

Science 

15. At the EPA, science provides the foundation for Agency policies, actions, and decisions 

made on behalf of the American people. What should the role of science be in the 

interpretation and implementation of EPA policies, rules, and regulations? 

High quality science is an essential predicate to many of the decisions that EPA 

makes. The role of science is critical to EPA's essential mission of protecting human 

health and the environment. 

16. Do you support relying on independent scientists with relevant expertise to evaluate and 

review the data that the EPA uses when making decisions related to the implementation 

of environmental regulations? 

I support the roles of scientists in helping EPA in its mission of protecting human 

health and the environment. 

Congressional Relations 

17. If confirmed, do you commit to assuring staff in the Oftice of the General Counsel will 

respond to all relevant inquiries from all Members of Congress, regardless of party or 

position? 

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Yes. 

Most Pressing Challenges 

18. The EPA's FY18 budget lists the following as priorities: clean water and drinking water, 

infrastructure, work at Brownfields and Superfund projects, improving and protecting air 

quality, and ensuring the safety of chemicals. If confirmed, would these also be the most 

pressing challenges that deserve your and OGC's attention? If con finned, how will you 

ensure OGC better addresses these challenges? 

If confirmed, I would manage OGC's functions within the authority and budget 

provided by Congress. I would request a full briefing by OGC staff on the 

ongoing work of the office and after understanding the scope of its current 

commitments set priorities based on legal requirements, the needs of the client 

program offices, and the priorities of the Administrator. 

Primary Environmental Enforcement by the States 

19. When giving advice to the EPA's staff, how will you balance the EPA's obligation to 

enforce the nation's environmental laws and regulations where the state and federal 

governments share authority? 

If confirmed, I would advise EPA staff that it is essential for the federal government 

and state governments to work together to provide the environmental protection 

that our laws demand and that the American people deserve. Many federal 

environmental statutes are designed with states as a primary implementer. EPA 

and the states should respect the design of cooperative federalism inherent in the 

law and leverage the assets of each other to achieve greater outcomes. 

Environmental Regulations 

20. As you may know, the EPA proposed to repeal the Obama Administration's Clean Power 

plan regulations to address atmospheric carbon pollution. If you are confirmed, will you 

commit to ensuring that in whatever replacement the Trump Administration makes to the 

Clean Power Plan, the EPA continues to fulfill its obligations under Massachusetts v. 

EPA? 

It would be inappropriate for me to prejudge the outcome of a matter that may 

come before me if confirmed as General Counsel. If confirmed, I would commit to 

offer counsel supporting the rule oflaw in this or any other EPA action, including 

advising the Agency on Supreme Court precedent, such as Massachusetts v. EPA. 

Senator Whitehouse: 

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21. Administrator Pruitt has been criticized for spending a disproportionate amount of his 

time meeting with industry and virtually no time with public-interest groups. If 

confim1ed, will you commit to meet with and listen to all parties in a balanced fashion? 

It is important for EPA to be accessible to the public and the regulated community. 

While the primary role of the General Counsel is to advise EPA policy-makers, if 

confirmed, I would attempt to meet with entities affected by the Office of General 

Counsel, while abiding by all legal and ethical limitations. 

22. The President's budget proposes to cut EPA's budget by 30%. The Office of General 

Counsel oversees ethics and FOJA. Based on what I've seen, EPA's Office of General 

Counsel is struggling to keep its head above water with current resources. For example, 

I've sent ethics-related inquiries to EPA, including one in May about an appointee with 

extensive conflicts of interest, that EPA has either not responded to or provided slow and 

incomplete responses. I've seen one inadequate recusal for former Baker Hostetler 

attorney Justin Schwab that took six months to fix. In the update recusal statement we 

learned that one of Mr. Schwab's clients was the State of Oklahoma. As of September 29, 

2017, EPA had over 2,100 open FOlA requests and outside groups, including the 

California Attorney General have filed suit over long-languishing requests. 

a. Do you believe these response times to Congress and the public are 

acceptable? 

I am not familiar with the specific details of these requests. If 

confirmed, I would request a briefing by EPA staff on OGC's 

history in responding to Congressional and FOIA requests. 

b. Do you believe the President's budget, if enacted, would provide 

enough money for your office to fulfill its ethics requirements and 

respond to Congress and FOIA requests from the public? 

If confirmed, I will manage OGC's functions within the authorities 

and budget provided by Congress. 

c. What specific steps will you take as General Counsel to ensure that 

responses to congressional inquiries and FOIA requests are made in 

the most expeditious manner possible? 

If confirmed, I would request a full briefing by OGC staff on 

the ongoing work of the office and after understanding the scope of 

its current commitments set priorities as appropriate for responses to 

requests for information. I would work with members of Congress to 

provide requested information, while respecting legal privileges and 

the role of the Executive branch. 

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23. If confinned, do you commit to notifying the Committee of all of the email addresses you 

plan to use upon confirmation and within seven days of using a new email address, 

including any aliases or pseudonyms? Do you commit do conducting all business using 

official email addresses and other means and to refrain from any mediums that are 

outside the Freedom oflnformation Act's reach? 

If confirmed, I commit to notifying the Committee of the e-mail address I use for 

official business. If confirmed, I commit to following EPA's Records Policy and the 

Federal Records Act. 

24. Have you heard anything to suggest that EPA may close or consolidate any Regional 

Offices? 

a. What is your opinion of such a proposal? 

I am not aware of any such plans. 

25. Do you a believe that climate change is real'? 

Yes. 

26. EPA Administrator Pruitt recently told CNBC that "I would not agree that [carbon 

dioxide's] a primary contributor to the global wanning that we see." Based on the 

scientific findings from expe1ts such as NOAA and statements on EPA's website, 

including "Carbon dioxide is the primary greenhouse gas that is contributing to recent 

climate change," Politi fact determined that statement to be false. Do you agree with 

Administrator Pruitt or scientific experts regarding whether carbon dioxide is the primary 

greenhouse gas that is contributing to climate change'? 

I believe that carbon dioxide contributes to climate change. 

27. In 2009, as mandated by the Supreme Court and backed by a robust scientific and 

technical review, the Environmental Protection Agency produced the Endangerment and 

Cause or Contribute Findings for Greenhouse Gases (GHGs) under Section 202(a) of the 

Clean Air Act. It found six greenhouse gases - carbon dioxide, methane, nitrous oxide, 

hydrofluorocarbons, perfluorocarbons, and sulfur hexafluoride - "taken in combination 

endanger both the public health and the public welfare of current and future generations." 

Do you agree with the EPA's endangennent finding? Why or why not? 

If confirmed, I would commit to advising the Agency on Supreme court precedent, 

such as Massachusetts v. EPA and the Agency's Endangerment Finding on 

Greenhouse Gases respective to the relative statutory framework established by 

Congress. 

28. Do you believe the U.S. should remain a party to the United Nations Framework 

Convention on Climate Change? 

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The United Nations Framework Convention on Climate Change is an international 

agreement. The US Department of State has primary responsibility for such 

matters. I defer to the State Department on this issue. 

29. Do you believe the U.S. should remain a party to the Paris Agreement? 

The Paris Agreement is an international agreement. The US Department of State 

has primary responsibility for such matters. I defer to the State Department on this 

issue. 

30. Do you support the amendment to the Montreal Protocol to phase down HFCs? 

The Montreal Protocol is an international agreement. The US Department of State 

has primary responsibility for such matters. I defer to the State Department on this 

issue. 

31. If confirmed, do you commit to providing complete and accurate responses to inquiries 

from EPW members in a timely fashion? 

Yes. 

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495 

Senator BARRASSO. Thank you very much, Mr. Leopold, and congratulations. 

Mr. Ross. 

STATEMENT OF DAVID ROSS, ASSISTANT ATTORNEY GENERAL, STATE OF WISCONSIN, AND DIRECTOR, WISCONSIN 

DEPARTMENT OF JUSTICE ENVIRONMENTAL PROTECTION 

UNIT 

Mr. ROSS. Chairman, I would like to first introduce my family. 

With me are my wife, Tiffany, and my girls, Payton and Kennedy, 

who are sitting behind me. The girls are here on special assignment from their social study classes back in Waunakee, Wisconsin. 

[Laughter.] 

Mr. ROSS. My brother, Admiral Eric Ross, is also here. Eric is 

taking time out of his busy schedule to attend today. Eric had the 

honor of being confirmed by the U.S. Senate as a Rear Admiral in 

the U.S. Navy earlier this year, and I thank the Senate for that 

family honor. 

My mother, Sue, and my sister, Debbie, are back home, hopefully 

participating, watching right now. 

Chairman Barrasso, Senator Carper, and distinguished members 

of this Committee, I am honored to be here today, and I want to 

thank President Trump and Administrator Pruitt for placing their 

trust in me and for providing me with this amazing opportunity to 

serve the public as the Assistant Administrator for EPA’s Office of 

Water. 

I also want to thank my wife, Tiffany, my amazing girls, Payton 

and Kennedy, and the rest of my family for their support as I continue my career in public service. 

And Chairman Barrasso, I want to thank you for the introduction and for your support during my time working for the great 

State of Wyoming. 

I have worked on water quality and resource management issues 

my entire career. My experience ranges from serving as a consultant on wastewater reclamation and reuse projects, to advising 

members of the regulated community on Clean Water Act compliance and related matters, to serving as the lead water quality attorney for the State of Wyoming and currently as the lead environmental prosecutor for the State of Wisconsin. I, therefore, understand water resource issues from multiple perspectives, and I have 

a deep appreciation for the complexity inherent in managing those 

waters. 

Our waterways help transform the nation into an economic 

power, and they continue to support economic activity that sustains 

our position in the world. They move commerce, supply power, provide drinking water, sustain wildlife, grow crops, and serve as playgrounds for outdoor enthusiasts. These competing uses highlight 

the critical importance of our nation’s water resources, but they result in divergent views on how best to manage those resources. 

The Office of Water must consider those diverse perspectives 

while pursuing common objectives, including protecting and enhancing the quality of our water, ensuring that our citizens have 

access to safe and reliable drinking water, and promoting regulatory certainty. 

496 

I will pursue those objectives based on a few core principles. 

First, we must manage our nation’s waters within the statutory 

framework established by Congress, while respecting the constitutional limitations imposed by our founding fathers. If I have a bias 

as a lawyer, it is a profound respect for the rule of law. 

Second, I will respect the role of States, tribes, and local governments as key partners in managing our nation’s water resources. 

I have been fortunate to observe firsthand the expertise and professionalism of State environmental officials and their dedication to 

the protection of the resources that they know best. I have also witnessed the frustration those environmental experts experience 

when the Federal Government fails to engage with them on matters of critical importance to the States. Should I be confirmed, I 

will embrace cooperative federalism as envisioned by Congress 

when it enacted many of the statutes that govern the work of EPA. 

Third, and finally, I will manage with an open mind, I will seek 

the input and expertise of the dedicated career professionals at 

EPA, I will listen to the advice and recommendations of the regulated community and the rest of the American public, I will engage 

with the States, tribes, and local governments, and I will pursue 

the objectives of my management with dedication, while always 

striving to give them my best counsel. 

The nation has made great progress improving the quality of our 

waters over the past 50 years. There is certainly more work to do, 

but I am confident that we can continue to make progress while 

pursuing the twin goals of environmental protection and economic 

prosperity for the nation. Indeed, to be successful, I think those 

goals are—and must be—interdependent. 

Thank you for your time today and the opportunity to appear. I 

look forward to answering any questions that you may have, and 

more importantly, to working collaboratively with all members of 

this Committee and your colleagues in both chambers, should I 

have the honor of being confirmed. 

[The prepared statement of Mr. Ross follows:] 

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27172.481

David Ross 

Director of the Environmental Protection Unit 

Wisconsin Department of Justice 

Mr. Ross currently serves as the Director of the Environmental 

Protection Unit for the Wisconsin Department of Justice. He 

previously served as a senior assistant attorney general in the 

Wyoming Attorney General's Otl'ice, where he represented the 

Environmental Quality on water quality matters. Mr. Ross also 

represented the State of Wyoming on the Assumable Waters Subcommittee of the National 

Advisory Council for Environmental Policy and Technology. Prior to entering public service, 

Mr. Ross practiced environmental law in Washington DC and worked as an environmental 

consultant in California. 

Mr. Ross attended the University of Wisconsin-Madison for undergraduate studies, and grew up 

in Appleton, Wisconsin. He earned his law degree and a Master of Studies in Environmental 

Law from V crrnont Law School. While in law school, Mr. Ross served as Editor-in-Chief of the 

Vermont Law Review. 
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Statement of David Patrick Ross 

Nominated to be Assistant Administrator for the Office of Water 

United States Environmental Protection Agency 

Before the Senate Environment and Public Works Committee 

September 2Q1h, 2017 

Chairman Barrasso, Senator Carper and distinguished members of the Committee, I 

am honored to appear before you today as the nominee to serve as the Assistant 

Administrator for the Office of Water within the U.S. Environmental Protection Agency. I 

want to thank President Trump and Administrator Pruitt for placing their trust in me and for 

providing me with this amazing opportunity to serve the public in such a critical role. I also 

want to thank my family for their incredible support and encouragement as I continue my 

career in public service. 

I have worked on water quality and resource management issues my entire career. 

pursued a career in environmental law and policy after growing up paddling the Boundary 

Waters and other lakes and streams with my father and friends, and have stayed that course 

my entire professional career. My experience ranges from serving as a consultant on 

wastewater reclamation and reuse projects, to advising members of the regulated 

community on Clean Water Act and related matters, to serving as the lead water quality 

attorney for the State of Wyoming and as the lead environmental prosecutor for the State of 

Wisconsin. I therefore understand water resource issues from multiple perspectives, and 

have a deep appreciation for the complexity inherent in managing our nation's waters. 

Our waterways helped transform the nation into an economic power, and continue to 

support economic activity that sustains our position in the world. They move commerce, 

supply power, provide drinking water, sustain wildlife, grow crops, and welcome 

recreational uses of all kinds. These competing uses highlight the critical importance of our 

1 
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27172.483

nation's water resources, but result in divergent views on how best to manage those 

resources. The Office of Water must consider and balance those diverse perspectives while 

pursuing important common objectives: protecting and enhancing the quality of our waters; 

ensuring that our citizens have access to safe and reliable drinking water; and promoting 

regulatory certainty for the regulated community. 

I will pursue those objectives based on a few core principles. First, we must manage 

our nation's waters within the statutory framework established by Congress while 

respecting the constitutional limitations imposed by our founding fathers. If I have a bias as 

a lawyer, it is a profound respect for the rule of law. 

Second, I will respect the role of states, tribes and local governments as key partners 

in managing our nation's waters. I have been fortunate to observe firsthand the expertise 

and professionalism of state environmental officials and their dedication to the protection of 

the natural resources they know best. I have also witnessed the frustration those experts 

experience when the federal government fails to engage with them on matters of critical 

importance to the states. Should I be confirmed, I will embrace cooperative federalism as 

envisioned by Congress when enacting many of the statutes that govern the work of EPA. 

Third, I will manage with an open mind. I will seek the input and expertise of the 

dedicated career professionals at EPA, I will listen to the advice and recommendations of the 

regulated community and other members of the public, I will engage with the states, tribes 

and local governments, and I will pursue the objectives of my management with dedication 

while always striving to give them my best counsel. 

The nation has made great progress improving the quality of our waters over the past 

50 years. There is certainly more work to do, but I am confident that we can continue to 

2 
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27172.484

make progress while pursuing the twin goals of environmental protection and economic 

prosperity for the nation. Indeed, to be successful, I believe those goals are and must be 

interdependent. 

Thank you for your time today and the opportunity to appear. I look forward to 

answering any questions you may have, and to working collaboratively with members of this 

Committee and your colleagues in both chambers should I have the honor of being 

confirmed. 

3 
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27172.485

Senate Committee on Environment & Public Works 

Hearing entitled, "Hearing on the Nominations of Michael Dourson, Matthew Leopold, 

David Ross, and William Wehrum to be Assistant Administrators of tire Environmental 

Protection Agency, and Jeffery Baran to be a Member of tire Nuclear Regulatory 

Commission." 

October 4, 2017 

Questions for the Record for Mr. David Ross 

Ranking Member Carper: 

I. For decades, both Republican and Democratic administrations alike have had written 

policies limiting White House contacts with agencies that have investigatory and 

enforcement responsibilities. These policies have recognized that even a simple phone 

call from the White House to an agency inquiring about or flagging a specific matter can 

upset the evenhanded application of the law. I recently learned that Devon Energy, a 

strong political supporter of Administrator Pruitt's, informed the EPA just 5 days after 

Mr. Pruitt was sworn in as Administrator that it was no longer willing to install air 

pollution technology or pay a high penalty to EPA for its illegal air emissions of cancercausing benzene and other chemicals. We also know that Trump family casinos, hotels 

and golf courses have been the subject of EPA enforcement actions for violations of the 

Clean Air Act and Clean Water Act. 

a. Do you agree that it is essential that in making decisions, EPA's OW must be 

shielded from political influence and spared even the appearance of being subject 

to political influence or considerations? 

If confirmed, I commit to work with Administrator Pruitt and his team to ensure 

strict compliance with all legal and ethical obligations. 

b. Will you commit to restricting communications between OW and the White 

House staff regarding specific matters under the authority of OW? 

If confirmed, I commit to work with Administrator Pruitt and his team to ensure 

strict compliance with all legal and ethical obligations. 

c. Will you commit to ensuring the staff of OW is familiar with those restrictions? 

If confirmed, I commit to work with Administrator Pruitt and his team to ensure 

strict compliance with all legal and ethical obligations. 

d. Will you commit to advising this Committee within one week if any inappropriate 

communications from White House staff to OW staff, including you, occur? 

If confirmed, I commit to work with Administrator Pruitt and his team to ensure 

strict compliance with all legal and ethical obligations. 

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2. Recently, EPA conducted "anti-leaking" training for its employees 1

• According to EPA 

sources, the briefing stated that "Prohibitions we will discuss do not refer to 

"Whistleblowing". Agency employees have the right to make lawful disclosures to 

anyone, including, for example, management officials, the Inspector General, and/or the 

Office of Special Counsel. Employees may make disclosures to the EPA Office ofthe 

Inspector General through the EPA OIG Hotline at 888-546-8740." This presentation 

evidently failed to note the rights of federal employees have to make disclosures to 

Congress. 

5 U.S.C. § 7211, provides that: The right of employees, individually or collectively, to 

petition Congress or a Member of Congress or to furnish information to either House of 

Congress, or to a committee or Member thereof, may not be interfered with or denied. 

Pursuant to 5 U.S.C. § 2302(b)(8), it is a violation of federal law to retaliate against 

whistle blowers. That law states: Any employee who has authority to take, direct others 

to take, recommend, or approve any personnel action, shall not, with respect to such 

authority ... take or fail to take, or threaten to take or fail to take, a personnel action with 

respect to any employee or applicant for employment because of ... (A) any disclosure of 

information by an employee or applicant which the employee or applicant reasonably 

believes evidences - (i) a violation of any law, rule, or regulation, or (ii) gross 

mismanagement, a gross waste of funds, an abuse of authority, or a substantial and 

specific danger to public health or safety, any disclosure to the Special Counsel, or to the 

Inspector General of an agency or another employee designated by the head of the agency 

to receive such disclosures, of information which the employee or applicant reasonably 

believes evidences a violation of any law, rule, or regulation .... " In addition, pursuant to 

18 U.S.C. § 1505, it is against federal law to interfere with a Congressional inquiry: 

Whoever corruptly, or by threats or force, or by any threatening letter or communication 

influences, obstructs, or impedes or endeavors to influence, obstruct, or impede the due 

and proper administration of the law under which any pending proceeding is being had 

before any department or agency ofthe United States, or the due and proper exercise of 

the power of inquiry under which any inquiry or investigation is being had by either 

House, or any committee of either House or any joint committee of the Congress. 

a. If you are confirmed, will you commit to protect the rights of all career employees 

in OW to make lawful disclosures, including their right to speak with Congress? 

If confirmed, I commit to ensuring that the Office of Water and its employees 

comply with and recognize all applicable legal and ethical requirements and 

protections. 

b. Will you commit to communicate employees' whistleblower rights via email to 

all OW employees within a week of being sworn in? 

If confirmed, I commit to protecting the rights of all EPA employees and will 

follow the law. 

1 https:Uwww.washingtonpost.com/politics/whitehouse/federal-employees-are-ordered-to-attend·antHeakingclasses/2017/09/21/032b40d6-9edd-lle7-b2a 7-bc70b6f98089 story.html?utm term=.e2bfc5e54d95 

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3. On February 28, 2017, President Trump directed EPA and the Army Corps to review and 

possibly rescind or repeal the Clean Water Rule in Executive Order 13776. EPA recently 

ended the public comment process on the first step of a two-step process to repeal the rule 

and replace it with a rule that will protect far fewer sources of drinking water. 

Individuals with first-hand knowledge of the process EPA utilized to prepare its have 

informed my staff that: 

i) When EPA first submitted the proposed repeal rule to OMB, the draft stated that 

the agency would undertake a new cost-benefit analysis as part of the second step 

of its process. 

ii) OMB interpreted EPA's first proposal to mean that the rule's repeal would not 

avoid any costs to industry or have any economic impact at all. EPA's political 

staff then directed the career staff to undertake a new economic analysis. In 

response to this direction, EPA career staff reportedly changed the table included 

in the 2015 rule to a) reflect 2016 dollars instead of 2014 dollars, b) convert 

"annual costs incurred" under the Clean Water Rule to "annual costs avoided" due 

to its repeal and c) convert "annual benefits gained" under the Clean Water Rule 

to "annual benefits forgone'' due to its repeal. This new table was sent to OMB on 

June 8, 2017. 

iii) OMB correctly concluded from EPA's June 8 submittal that repealing the rule 

would cost more in lost benefits than it would save industry in compliance costs. 

On June 13, 2017, presumably to avoid such an admission on the part of EPA, 

EPA career staff were verbally directed by political staffto solve this 'problem' 

by simply deleting the majority ofthe benefits of the rule from the table and resubmitting it to OMB, which they did2 • 

a. Ifthe events above occurred as described to my staff. do you agree that EPA's 

failure to even attempt to undertake a credible cost-benefit analysis of its proposal 

to repeal the Clean Water Rule would be vulnerable to assertions that the agency 

ran afoul of both the Clean Water Act and the Administrative Procedure Act? 

Why or why not? 

Should I be confirmed, I look forward to engaging in the rulemaking process, 

including working with the Office of General Counsel to ensure the 

development of a robust administrative record that is grounded in the law. 

'https;//www.epa.gov/sites/production/files/2017·06/documents/economic analysis proposed stepl rule.pdf 

See Table 1 

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b. The direction that was reportedly provided to the EPA career staff to make the 

various revisions to what was submitted to OMB was verbal, not written. If you 

are confirmed, do you commit to ensure that career staff in OW will receive 

appropriately documented, rather than verbal, direction from political officials 

before they take action? If not, why not? 

I support the appropriate use of both written and oral guidance and would 

endeavor to use each in appropriate circumstances. 

4. As someone with substantial experience with states' perspectives on the role of states in a 

federalist regulatory framework, would you agree that environmentally protective 

strategies developed by states individually and jointly should be given strong deference 

by federal regulatory agencies like EPA? 

Yes, as long as the states comply with baseline federal requirements. 

a. Given that respect for state responsibilities and initiative, would you bring the full 

force of your authority at EPA to ensure that the Chesapeake Bay states live up to 

their commitments to reduce pollution loadings under the Chesapeake Bay 

TMDL? 

Should I be confirmed, I will implement tbe Office of Water program 

authority to work collaboratively with the states in the Chesapeake Bay 

region to achieve the targeted water quality improvements in the Bay. 

5. Given your substantial experience working with state water programs and as a member of 

the Assumable Waters Subcommittee of the National Advisory Council for 

Environmental Policy and Technology, do you support state assumption of Clean Water 

Act responsibilities and programs? 

Yes. 

a. Assuming you support active state engagement in implementing and enforcing 

Clean Water Act responsibilities, how do you feel about substantially reducing 

federal funding to state partners to handle these federal obligations? 

I support strong federal partnership and collaboration with the states, both 

financially and logistically, to achieve success in implementing the delegated 

state programs. 

b. Do you agree with the philosophy that if states assume primary responsibility for 

keeping their water clean that the federal government should not provide any 

funding to support their efforts? Why or why not? 

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I believe in shared financial responsibility and collaborative partnerships 

with the states in order to realize the promise of cooperative federalism 

envisioned by the Clean Water Act. 

c. Do you believe from your experience in Wyoming and Wisconsin and familiarity 

with the financial, technical and legal capacities of other states that they can take 

care of the nation's water quality on their own? 

I believe we can achieve greater success in managing the nation's waters 

through leveraged relationships, including providing financial and technical 

support to the states. 

d. How important is EPA's oversight of states' compliance with their Clean Water 

Act responsibilities? 

EPA's oversight and technical support is important in helping the states 

effectively implement the many Clean Water Act programs. 

e. What can EPA do better to ensure that states are doing their jobs, for example to 

prevent future water crises as we saw with lead in drinking water in Flint, 

Michigan? 

I believe that EPA can focus on building relationships to establish trust in the 

collaborative partnership, with smarter, more focused oversight that 

emphasizes core program areas and responsibilities and deemphasizes box· 

checking exercises. Effective oversight depends on effective prioritization and 

shared ownership in establishing those priorities. 

6. Do you feel that the Clean Water Act overly limits the ability of developers and 

agricultural producers to conduct their business and support themselves and the nation's 

economy? 

If implemented correctly and within the legal guideposts established by Congress, 

no. 

a. Would you advocate rolling back clean water regulation beyond the Clean Water 

Rule that require developers and agriculture producers to reduce the adverse 

impacts of their operations on water quality? Jf so, which ones and why? 

I support the development of a predictable and clear regulatory scheme that 

stays within the legal framework established by Congress while respecting 

the Constitutional limitations placed on both Congress and the Executive 

Branch agencies. This basic principle should apply to all EPA regulations, 

including the development of a regulatory definition for the term "waters of 

the United States." 

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b. Are there other sectors of the economy you feel are over-regulated by Clean 

Water Act programs? If so, which ones, and what do you advocate EPA 

should/could/would do to alleviate the burden? 

I do not enter federal service with any pre-determined views on this topic. 

7. The Farm Bureau has come out strongly against the Clean Water Rule (CWR). But the 

CWA section 404(1), which was enacted in 1977, specifically exempts normal farming 

activities including the construction of roads, ditches, and fllfm ponds. The CWR does 

not impinge on section 404(1) at all. Which specific farm activities does the CWR affect 

that are currently exempted under the 2008 guidance that is now in place? 

If confirmed, I look forward to learning more about how the agency has 

implemented 404(1) to ensure the agency has provided the exemptions Congress 

intended. 

8. Did EPA formulate a new, updated legal rationale for embracing the current waters of the 

United States definition through its proposed repeal and replacement of the Clean Water 

Rule? If so, please describe your understanding of the rationale. 

I am not familiar with the legal analysis EPA performed as part of its ongoing effort 

to implement President Trump's February 28, 2017 Executive Order. 

9. Coal-fired power plants are by far the largest discharger of toxic water pollution in the 

US. In 2015, an effluent limitations guidelines (ELG) rule was finalized that would 

require power plants to eliminate the vast majority of this pollution using readily 

available, affordable wastewater treatment technology. In the last few months, 

however, EPA has postponed the compliance dates for two waste streams in the rule and 

begun a new rulemaking to reconsider the standards for these waste streams. EPA bas 

argued that the 2015 rule was too cost-prohibitive to industry, yet the vast majority of 

power plants will incur zero costs to comply with the 2015 ELG rule. EPA bad 

previously estimated that complying with this rule would prevent 1.4 billion pounds of 

toxic pollutants, including known carcinogens like arsenic and known neurotoxins like 

lead and mercury, from being discharged into waterways each year. 

a. How will you ensure that any revised Steam ELG standards and/or limits do not 

negatively impact drinking water systems? 

The development of effluent limitation guidelines are governed by regulatory 

procedures that take into account applicable legal, technical, economic and 

other important considerations. If confirmed, I will work to ensure that 

Office of Water personnel follow those procedures to develop an appropriate 

and protective standard. 

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b. In its proposed revisions to the 2015 power plant ELG, should EPA consider 

technology options for treating flue gas desulfurization waste that would limit 

bromide discharges from power plants? Why or why not? 

Should I be confirmed, I look forward to evaluating the status of the 

regulatory effort at that time, including potential options for that particular 

waste stream. 

10. Do you agree to provide complete, accurate and timely responses to requests for 

information submitted to you by any Member ofthe Environment and Public Works 

Committee? If not, why not? 

Yes. 

11. Recently, EPA announced that Administrator Pruitt would be publishing brief summaries 

of his calendars biweekly, after dozens of Freedom oflnformation Act requests for this 

information as well as a March request by me and my colleagues that he do so. During 

the Obama Administration, the Administrator, regional Administrators and all those 

serving in confirmed roles published their calendars daily3

• If you are confirmed, will 

you commit to publishing your calendars daily? If not, why not? 

If confirmed, I will make my calendar available on a timely basis. 

12. You are currently the Wisconsin Department of Justices' Environmental Protection Unit 

Director. It is your responsibility to manage environmental litigation and prosecute 

violations of state environmental law. 

a. Under the cooperative federalism structure of many of our environmental statutes, do you 

believe the federal government, and EPA in particular, is an important partner to state 

environmental work? 

Yes. 

b. The Trump Administration has proposed reducing funding for the Office of Enforcement 

and Compliance Assurance by 24 percent. In your opinion, how would a funding cut of 

this size affect the partnership between Wisconsin and EPA? 

I am not familiar with the details of the FY18 budget but if confirmed I will work 

collaboratively with tbe Office of Enforcement and Compliance Assurance to 

uphold the mission of the EPA. 

3 htt ps :/lyosem ite.epa. gov I opal ad mpress. nsf I Calendars ?0 pen View 

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c. If the Wisconsin Department of Justice's Environmental Protection Unit was cut by 24 

percent, how would that affect the ability of your unit to perform its statutory 

responsibilities? 

I am not in a position to comment on hypotheticals, and the issue is entirely 

dependent on a variety of factors. 

13. The Trump Administration has proposed eliminating the Great Lakes Restoration 

Initiative. This would cut $300 million dollars in funding to states like Wisconsin for 

environmental restoration activities designed to improve the health of the Great Lakes. 

You have been nominated to head the Office of Water. Do you support the proposed 

elimination of EPA's Geographic Programs funding? What impact will this have on the 

Great Lakes? If this program is eliminated, how would you, if confirmed, accomplish 

your statutorily required objective to improve the health of the nation's waters, including 

the Great Lakes?_In particular, how would the elimination of this program affect 

multi state and binational commitments and initiatives to deal with non-point source 

pollution issues and resulting algal blooms, as described in an October 3, 2017 New York 

Times artic!e4? Do you support designation of the Western portions of Lake Erie as 

impaired and development of a TMDL to identify and reduce the loadings of nutrients, 

especially phosphorus, that contribute to the problem? 

If confirmed, I will work with Office of Water and regional staff to implement the 

budget Congress provides for the Great Lakes program as effectively and efficiently 

as possible. Should I be confirmed, I look forward to working with our state 

partners to holistically address the ongoing challenge of nutrient loading in Lake 

Erie. 

4 https :1/www. nvti m es.co m/interactive/20 17/1 0/03/sci ence/ earth /Ia ke-eri e. ht m l?s m id=tw-sha re& r=O 

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Senator Booker: 

14. Our nation's water infrastructure is in desperate need of repair. Ongoing water 

contamination in Flint, Michigan and the challenges presented by natural disasters like 

Hurricanes Irma and Maria, which left Puerto Rico without access to clean, safe drinking 

water underscore the importance of having a skilled water workforce, including pipe 

fitters, electricians, carpenters, treatment operators. Water access also drives economic 

growth. For every day of water service disruption, the average U.S. business loses $230 

in sales per employee. 

a. Seeing the potential impact on public health, safety, and the environment, several 

municipalities have already launched innovative and successful efforts to drive workforce 

development. For example, the City of Camden in my home state ofNew Jersey has 

partnered with local secondary schools to introduce students to utility work and develop 

skills. To replicate these efforts across the country, would you urge the Administrator to 

support a federal water workforce grant program that leverages local funds and drives 

water workforce recruitment? 

If confirmed, one of my top priorities is to identify innovative state and local 

projects and provide a platform for replicating their success nationally. I look 

forward to learning more about the City of Camden project and others like it so 

that I can formulate legal, policy and funding recommendations to the 

Administrator while at the same time working to encourage and facilitate ongoing 

innovation at the local level. 

b. Over the next 40 years, the federal government will need to invest approximately $1.7 

trillion to update pipes that provide clean drinking water to Americans (according to the 

American Water Works Association). Would you look for ways to improve and 

incorporate water workforce as part of any infrastructure package? 

Yes. I think workforce development helps drive innovation and is key to 

implementing innovation when realized. 

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Senator Cardin: 

15. The District Court for the Middle District of Pennsylvania, where you represented the 

plaintiffs challenging the TMDL, upheld the TMDL as a valid exercise of EPA's powers 

under the Clean Water Act. In upholding the TMDL. the District Court provided 

welcome certainty as the states carry out the complex task of developing their own plans 

for meeting the cleanup goals set forth in the Bay TMDL. Key to the District Court's 

decision, which was affirmed by the Court of Appeals for the Third Circuit, was the 

TMDL's demonstrated commitment to cooperative federalism. The Bay states asked EPA 

to set pollution levels for the entire watershed in 2007 and, as the court emphasized. "no 

state has filed suit challenging the TMDL." 

a. Regarding the Chesapeake Bay Agreement, will you commit to allowing the will 

of the states to stand? 

Should I be confirmed, the Office of Water will remain committed to 

working with the Chesapeake Bay Watershed states to implement the 

principles outlined in the 2014 Agreement. 

b. If so, how do you plan to support them to achieve their goals? 

I believe we can help them achieve their goals by continuing to facilitate the 

principles of cooperative federalism and supporting the states as they 

implement the Bay TMDL and the other objectives of the 2014 Agreement. 

16. President Trump's proposed budget would eliminate federal funding for the cleanup of 

the Chesapeake Bay, just as the etTort reaches its halfway point. Through the Chesapeake 

Bay Program, the EPA awards millions in grants each year to the six states in the bay 

watershed-Virginia, Maryland, West Virginia, Pennsylvania, New York and Delaware 

and the District of Columbia-for restoration. 

a. Will you uphold EPA's commitments as a signatory of the 2014 Chesapeake Bay 

Watershed agreement, including allocation of funds appropriated by Congress? 

If confirmed, I will work to ensure that the Office of Water implements the 

budget Congress provides for the Chesapeake Bay program as effectively 

and efficiently as possible. The Office of Water will remain committed to 

working with the Chesapeake Bay Watershed states to restore the ecological 

health ofthe Bay. 

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17. The Clean Water Rule was found to be economically beneficial-$572 million dollars 

per year-to the American people. As you know, having cleaner water going into our 

taps makes treating and filtering it cheaper, or altogether unnecessary, for when it comes 

out of our taps to drink. Yet, EPA is now on a path to replace this very t1worable Clean 

Water Rule with another rule. 

a. Do you commit to use the best available peer-reviewed science in developing any 

new rule? 

Should I be confirmed, I will work to ensure that sound, peer-reviewed 

science supports, where applicable, the legal and policy decisions inherent in 

defining the statutory and regulatory term "waters of the United States." 

b. In such rulemaking, do you commit to include the best available peer-reviewed 

science in the valuation of the benefits provided by wetlands and the other Waters 

of the United States? 

As stated above, I will work to ensure that relevant, peer-reviewed sound 

science supports the legal and policy determinations implicit in any 

determination regarding the meaning of the term "waters of the United 

States," including applicable wetland valuation methodologies. 

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Senator Ernst: 

18. Administrator Pruitt has made engagement with rural America a priority and he has 

expressed particular concern over how EPA regulations, such as the Waters of the United 

States (WOTUS) rule, impact these local communities. In cases like WOTUS, the 

previous EPA did not fully analyze the costs associated with the regulation, particularly 

for rural communities. At the same time, the benefits of this rule, and others, were often 

overstated. How will you work to assure transparency when documenting the costs and 

benefits associated with EPA actions under your office? 

In my experience, the Agency can do a much better job of early-stage problem 

formulation through active engagement with states, tribes and local governments, 

members of the regulated community, external experts, and other interested 

stakeholders. All too often, stakeholder engagement and consultation occurs too late 

in the regulatory process. Cost-benefit analysis is one of many areas where early 

stage consultation would improve performance, as the analysis frequently 

accelerates to the valuation stage without clearly articulating the scope of the 

assessment and the specific data input needs. This problem is frequently 

compounded by a lack of comprehensive understanding of the regulated activity by 

those who regulate that activity. Significant enhancements, including trust in the 

regulatory process, can be achieved through better engagement and transparency 

earlier in the process. 

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Senator Markey: 

The EPA and the Army Corps of Engineers released a proposal to repeal the 20!5 Clean Water 

Rule a few months ago. 

!9. Do you feel that the Clean Water Act overly compromises the ability of developers and 

agricultural producers to conduct their business? 

If fairly and properly implemented within the statutory constraints imposed by 

Congress, no. 

20. Aside from the Clean Water Rule, will you advocate for rolling back other water program 

requirements that help prevent negative impacts on water quality? 

If confirmed, I will work to assure that the Office of Water objectively implements 

the laws that Congress has enacted to address the quality of the nation's waters. 

21. How will you ensure that credible and vetted scientific research will be used in your 

decisions as Assistant Administrator for the Office of Water? 

I will assure that the scientific research that is presented to me is credible, balanced, 

and objective and is targeted at the correct issues and questions. I will also establish 

a strong preference for peer-reviewed science wherever feasible. 

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Senator Sanders: 

Climate Change 

22. President Trump has suggested in the past that climate change is a hoax. Is the President 

correct? Is climate change a hoax? 

I believe that climate change is real and human activity contributes in some manner. 

23. Do you agree with the vast majority of scientists that climate change is real, is caused by 

human activity, and that we must aggressively transition away from fossil fuels and 

toward energy efficiency and sustainable energy like wind, solar, and geothermal? 

I believe that climate change is real and human activity contributes in some manner. 

24. Changes in weather patterns, such as heavier precipitation events that increase run-off 

and flooding, are affecting lakes, rivers, and reservoirs nationwide. Water quality, 

quantity, and the integrity of our water infrastructure are at risk. Recent studies in the 

Northeast have found that degraded water quality on lakes can cost lakeside communities 

millions of dollars in losses from both tourism and taxable income due to reduced 

property values. If confirmed, how will you support water resource management 

programs to address these issues? 

I will support water resource management programs to address these issues by 

implementing the core statutory programs as effectively as possible, prioritizing 

government's limited resources to focus on the most critical issues that return the 

greatest value for our tax payer and human capital investments, working with the 

states, tribes and local governments to leverage or shared resources and expertise, 

and streamlining our decision-making processes. 

Background 

25. In your past career, you have brought suit against the EPA for its enforcement of the 

Clean Water Act. Can you explain why federal courts should be in the position of 

determining safe levels of pollution to protect the health and welfare of Vermonters, as 

opposed to the federal Agency whose mission it is to protect human and environmental 

health? 

If EPA complies with the laws that Congress enacts and bases its decisions on 

balanced, objective science, accurate technological and economic analyses, and 

reasoned policy choices, federal courts should not be placed in such a position. The 

litigation process is a poor substitute for effective government decision-making. 

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26. Do you support the current stated goal ofthc Office of Water to "protect human health, 

support economic and recreational activities, and provide healthy habitat for fish, plants, 

and wildlife"? 

Yes. 

27. At the EPA, science provides the foundation for Agency policies, actions, and decisions 

made on behalf of the American people. What should the role of science be in the 

development of EPA policies. rules, and regulations? 

Sound, balanced, objective science is a key component of the EPA decision-making 

process, and works in tandem with the proper application of and respect for the rule 

of law to help guide the Agency's core missions. 

Most Pressing Challenges 

28. In your opinion, what are the most pressing water quality challenges that deserve the 

attention of the EPA? What will you do at the EPA to address these challenges? 

The nation's aging water and wastewater infrastructure in both urban and rural 

America is, in my opinion, our most pressing short- and long-term concern. I am 

pleased that both President Trump and Administrator Pruitt share that view. From 

a drinking water perspective, lead is a high priority water quality concern while 

nutrients remain our most difficult surface water quality challenge. 

Environmental Regulations 

29. How do you intend to work collaboratively with states in the event that a state violates 

the federal Clean Water Act or the Safe Drinking Water Act, or a state requests technical 

assistance from the EPA? 

Should I be confirmed, one of the first directives I will establish for the Office of 

Water program staff is to be fully and immediately responsive to state requests for 

technical assistance and to work hard to establish the relationships necessary to 

enable the free flow of those technical requests without concern for reflexive 

enhanced oversight or elevation into program authority review or enforcement. 

Should a state violation be discovered through self-reporting, oversight or other 

mechanisms, the focus should be on performing a root cause analysis to better assess 

and support planning to make sure the problem does not continue or reoccur. 

Collaborative enhancement is more timely and effective than coercive enforcement, 

particularly in the cooperative federalism model. 

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30. Then-candidate Trump stated that the lead poisoning in Flint, Michigan "would never 

have happened if I were president." Today, nearly 3,000 communities have lead 

poisoning levels higher than those found in Flint, Michigan. And, even Flint does not yet 

have clean drinking water. 

If confirmed, what actions will you take to ensure that every community has clean water 

to drink? 

Ensuring effective implementation of the Safe Drinking Water Act through strong 

partnerships with state, tribal and local governments, targeted oversight, and robust 

enforcement when necessary. 

What changes, if any, in environmental laws, policies and regulations will you need to 

ensure that a Flint-like situation never happens again? 

Modernization of the Lead and Copper Rule is a first step, but to fully answer this 

question I will need to perform a deep dive into the root cause of the Flint, Michigan 

crisis to be personally satisfied that the core issues in that crisis have been addressed 

and that state and local governments are getting the resources and attention they 

need to successfully address the problem. That analysis will then help inform my 

evaluation ofthe existing regulatory structure and its ability to prevent future 

Flints. 

31. Oil and natural gas extraction by way of hydraulic fracturing, or "fracking," has 

expanded rapidly in the United States. The EPA conducted a study of the drinking water 

impacts and released a final report in December 2016. The Agency found "hydraulic 

rracturing activities can impact drinking water resources under some circumstances." Do 

you concur with the conclusions of the EPA's final report on fracking and drinking 

water? 

I have not studied the report in detail, but I am familiar with the general conclusion 

quoted above. Under certain circumstances, hydraulic fracturing activities can have 

negative consequences if adequate precautions are not implemented. 

What further studies-if any--do you believe would be appropriate for the EPA to 

conduct on the effects of fracking on water quality? 

Another general conclusion of the report indicated that the existing data could 

support certain qualitative assessments, but not quantitative assessments. Future 

research might address that significant shortcoming in the available literature. 

If confirmed, would you support implementing a requirement to provide full, wellspecific public disclosure of all information related to oil and gas development involving 

hydraulic fracturing that informs understanding groundwater, surface water, public health 

and safety, and habitat potential impacts? 

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If confirmed, I would need to spend more time analyzing the available research and 

related information before developing an opinion or recommendation on the matter. 

Environmental Justice 

32. If confirmed, will you commit to addressing issues of environmental justice in Native 

American communities and offer a voice to those most affected by the environmental 

consequences of industrialization, especially in regard to resources protected by treaties, 

such as water rights? 

If confirmed, I look forward to working to ensure that the nation's environmental 

laws are implemented effectively for all Americans, including those most at risk or 

most impacted from the effects of degraded resources. 

33. Lake Champlain is one of Vermont's most treasured natural resources. Tourism and 

property values are tied to the health of the lake-and keeping its waters swimmable, 

fishable and drinkable is important to Vermonters. Run-off-including from farmlands, 

lawns, and paved roads and point source pollution contributes to high levels of 

phosphorus that spur algae growth. The algae turns the lake green and can be toxic. In 

2016, the EPA released new phosphorus limits for the lake by establishing a TMDL. As 

assistant administrator, will you continue the Agency's support for the clean-up of Lake 

Champlain through this new TMDL and federal funding? 

If confirmed, I will work with Vermont and New York to continue to make progress 

on addressing the ongoing water quality issues in Lake Champlain through 

implementation of the TMDL and other mechanisms. 

Specifically, should Vermont fail to make satisfactory progress toward meeting the 

TMDL, would you support increased funding and support from the EPA to crack down 

on pollution? If not, how will you ensure Clean Water Act obligations are satisfied? 

I understand that Vermont continues to make progress in implementing its shared 

commitments under the Lake Champlain TMDL, including pursuing the necessary 

funding for state program activities. Should I be confirmed, the Office of Water will 

continue to work with Vermont to provide the requisite support that is necessary to 

achieve lasting improvements in the Lake. 

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Do you as Assistant Secretary of Water commit to the EPA's partnership with the states 

in developing plans for, and responding to, the case of an oil spill that affects waters 

under its jurisdiction, such as Lake Champlain? 

EPA, together with its federal, state and local partners, performs an integral role in 

oil spill response planning for inland waters under existing authorities. Should I be 

confirmed, I would be happy to look into the status of planning efforts for Lake 

Champlain. 

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Senator Whitehouse: 

34. Given your professional history challenging the Clean Water Rule, how can I be assured 

that you will be impartial in future rulemakings to revoke, revise, or replace the rule? 

I fundamentally believe that a lawyer's most important skill is objectivity. Without 

that baseline skill, a lawyer cannot properly advise clients on the full scope of 

problems or see, let along recommend, holistic solutions. As the lead environmental 

prosecutor for Wisconsin, the public relies on our team to uphold the law with 

integrity and accuracy while ensuring the fair and impartial treatment of the 

regulated community. Those same skills will continue to inform and guide my 

decision-making should I be confirmed to lead the Office of Water. 

35. Your current boss, Wisconsin Attorney General Brad Schimel, recently co-led a comment 

letter from twenty-five state Attorneys General to EPA and the Army Corps on the Clean 

Water Rule revision effort. What role did you have in drafting this letter? 

None. 

36. What interactions did you have with representatives of the Republican Attorneys General 

Association in drafting this letter? 

None. 

37. Have you attended any Republican Attorneys General Association events, or supported in 

any capacity Wisconsin Attorney General Brad Schimel in his attendance or participation 

at these events? 

No. 

38. To your knowledge was EPA Administrator Scott Pruitt or any member of his staff 

involved in the drafting of the comment letter, either directly or indirectly through early 

drafts, attendance at meetings or other discussions where the letter was discussed, or any 

other familiarity with the letter before it was submitted as a formal comment to the 

agencies? 

I have no knowledge of the development process for the letter. 

39. Last year, the National Estuary Program (NEP) was reauthorized through 2021 at $26.5 

million per year. Just a few months after Congress reaffirmed its support of this program 

through the reauthorization, the President proposed terminating funding for the program 

through his FY2018 proposed EPA budget. Do you agree with the President's request to 

defunct the NEP? 

Should I be confirmed, I will work to implement the budget Congress provides for 

the Office of Water as efficiently and effectively as possible. 

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40. Do you believe wetlands provide economic benefits? Please explain what research and 

data you rely upon to come to that conclusion. 

Based on personal experience, I believe that wetlands have the potential to provide 

economic benefits aesthetically, ecologically and hydrologically. 

41. Rhode Island Department of Environmental Management completed a study earlier this 

year that identified seven of the nineteen major wastewater treatment plants in the state as 

likely to be predominately inundated by increased flooding risk due to climate 

change. All but one of these plants is along the coast where sea level rise and increased 

storm surge risks threaten the treatment facilities. 

a. Do you believe that climate change is real? 

I do believe that the climate is changing. 

b. EPA Administrator Pruitt recently told CNBC that "I would not agree that [carbon 

dioxide's] a primary contributor to the global warming that we see." Based on the 

scientific findings from experts such as NOAA and statements on EPA's website, 

including "Carbon dioxide is the primary greenhouse gas that is contributing to 

recent climate change," Politi fact determined that statement to be false. Do you 

agree with Administrator Pruitt or scientific experts regarding whether carbon 

dioxide is the primary greenhouse gas that is contributing to climate change? 

I believe there are several greenhouse gases that have the potential to 

contribute to climate change, including carbon dioxide. 

c. In 2009, as mandated by the Supreme Court and backed by a robust scientific and 

technical review, the Environmental Protection Agency produced the 

Endangerment and Cause or Contribute Findings for Greenhouse Gases (GHGs) 

under Section 202(a) of the Clean Air Act. It found six greenhouse gases- carbon 

dioxide, methane, nitrous oxide, hydro fluorocarbons, perfluorocarbons, and sulfur 

hexafluoride "taken in combination endanger both the public health and the 

public welfare of current and future generations." Do you agree with the EPA's 

endangerment finding? Why or why not? 

I have not studied the legal or technical basis for the endangerment finding. 

d. Do you believe that sea levels are rising? 

I think there is sufficient data to indicate that sea levels may be rising. 

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e. Do you believe that higher sea levels increase the risk to coastal communities 

from storm surges? 

If not properly managed through infrastructure and other means, higher sea 

levels have the potential to increase risk to coastal communities in storm 

surge events. 

f. Do you believe that increasing levels of carbon dioxide in the atmosphere 

contributes to sea level rise? 

Increasing levels of greenhouse gases in the atmosphere have the potential to 

contribute to sea level rise. 

g. Do you believe that anthropomorphic activities are at least in part responsible for 

increasing levels of carbon dioxide in the atmosphere? 

Yes. 

42. Do you believe that sea level rise can put drinking water and wastewater systems at risk? 

If not properly managed over the long term, yes. 

43. Would you support efforts to direct funding and technical assistance from the EPA 

towards readying coastal infrastructure for the effects of climate change? 

If EPA is appropriated such funds by Congress, yes, with a particular emphasis on 

aging water and wastewater infrastructure. 

44. Do you accept the basic science of ocean acidification, and that the rate of acidification is 

faster now than in the past 50 million years? 

I understand the basic science of ocean acidification, but have not studied those 

rates as compared to historic trends. Should I be confirmed, I look forward to 

studying the issue in greater detail. 

45. Do you believe the U.S. should remain a party to the United Nations Framework 

Convention on Climate Change? 

The role of the United States in the Framework Convention on Climate Change is 

an international agreement. The US Department of State bas primary responsibility 

for such matters. I defer to the State Department on this issue. 

46. Do you believe the U.S. should remain a party to the Paris Agreement? 

The Paris Agreement is an international agreement. The US Department of State 

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bas primary responsibility for such matters. I defer to the State Department on this 

issue. 

47. A 2016 Associated Press study of EPA data identified Providence, Rl as "one of the 

largest [drinking water systems] in the country to exceed a federal lead standard since 

2013." Almost 20 percent of all retail customers' homes were found to be serviced by 

utility-owned lead lines. EPA's lead limit before corrective action is required is currently 

15 parts per billion. The city's water supply was found to be over this limit six times 

since 2010. Providence's water hit 30 parts per billion in tests in 2009 and 

2013. Providence has shown marked improvement since those peaks, but there is still 

millions of dollars of investment needed in the city's drinking water infrastructure to 

reduce the risk of lead. What role do you believe EPA should play supporting these 

investments? 

Improving the nation's water infrastructure is and must be a shared responsibility 

oflocal, state, federal and private partnerships. EPA should continue to implement 

the state revolving fund and other grant appropriations as strategically as possible 

at whatever levels Congress provides, while continuing to pursue innovations in 

water and wastewater infrastructure financing mechanisms. 

48. What have you done in your career to demonstrate lead contamination of drinking water 

will be a priority if you are confirmed as EPA Administrator? Please cite specific 

examples. 

I spent the first four years of my career performing and supporting research on the 

efficacy of various forms of water and wastewater treatment systems as part of the 

City of San Diego's Total Resource Recovery Project and Aqua 2000 Research 

Center. Part of that research involved heavy metals testing and evaluating potential 

corrosivity concerns in potable water delivery systems. 

49. In an interview with the Providence Journal last April, Rhode Island's chief of the Center 

for Drinking Water Quality at the Rl Department of Health stated that "[i]n the last 

monitoring period, we had six small water systems exceed the lead action level. Five 

were school systems." These systems were brought back into compliance, but the concern 

remains. How will you prioritize lead abatement in schools and among the most 

vulnerable populations? 

By making sure that the WIIN Act, Safe Drinking Water Act and other authorities 

are implemented as effectively as possible in close coordination with our state and 

local partners. EPA must also continue to make progress on modernizing the Lead 

and Copper Rule. 

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50. EPA's regulations on lead in drinking water, otherwise known as the Lead and Copper 

Rule, were last revised in 2007. In its October 2016 white paper on revising the rule, the 

EPA recognized "[t]here is a compelling need to modernize and strengthen 

implementation of the rule--to strengthen its public health protections and to clarify its 

implementation requirements to make it more effective and more readily enforceable." 

Do you agree the Rule is in need of updating to reflect the latest science? Wilt you 

prioritize reviewing and updating the Lead and Copper Rule? 

Yes, and yes. 

51. Do you believe all covered water systems should follow EPA's drinking water analytical 

methods when testing drinking water for contamination? If so, what efforts will you 

undertake to ensure all water systems are brought into compliance? 

All covered water systems must comply with established standards for testing 

drinking water quality. Should I be confirmed, the Office of Water will continue to 

work with our local, state and regional partners to ensure that the requirements of 

the Safe Drinking Water Act are fully implemented. 

52. In a November 2016 interview with the New York Times, President-elect Trump 

specifically called out "crystal clear water" as a priority. Do you agree "crystal clear 

water" should be a priority of the EPA? If so, please list the specific steps you would 

take as Administrator to make the President-elect's vision a reality. 

I'm not familiar with the context or content of the interview, but I share the 

President's enthusiasm for what I assume from the quote is prioritizing safe and 

reliable drinking water for all Americans. 

53. Over 40,000 water bodies in the United States are considered "impaired" under Section 

303(d) of the Clean Water Act, meaning they do not meet water quality and health 

standards. What, if any, specifics steps have you taken to improve the water quality in 

these impaired waters in states in which you have worked on clean water issues? 

I provided legal advice to the Water Quality Administrator for the Wyoming 

Department of Environmental Quality and his TMDL development team while 

serving as the lead water quality attorney for the State of Wyoming, and in 

Wisconsin I facilitated the settlement of litigation brought by a tribe and local lake 

association seeking the development of a site-specific water quality criteria for 

phosphorus for an impaired lake in northern Wisconsin. The result of the settlement 

accelerated the work of the Wisconsin Department of Natural Resources in 

developing the requested water quality criterion. I also recently prosecuted a dairy 

farm in Kewaunee County, Wisconsin for manure management violations, and 

required as part of the settlement implementation of at least 100 acres of seasonal 

cover crop on highly erodible soils and the development and maintenance of 

approximately nine acres of vegetated filter strips along and near the Kewaunee 

River, portions of which are impaired by phosphorus. 

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54. What clean water initiatives undertaken by the EPA in the last five years do you support? 

I support EPA's efforts on integrated planning, enhancements in green 

infrastructure and storm water management planning for municipalities, innovative 

financing developments for water infrastructure projects, the nutrient recycling 

challenge, and better recognition of state partnerships as key to solving the nutrient 

loading challenges in the Mississippi River Basin, to name a few. 

55. Factory farming of animals is known to cause multiple forms of pollution, such as 

contaminating local groundwater with nitrates, contributing to hypoxia and "dead zones" 

in rivers and coastal waters, and releasing the potent greenhouse gas methane. Do you 

commit to enforcing the Clean Water Act to the fullest extent of the law to protect the 

public from pollution from animal feeding operations? 

I commit to fully and fairly implementing the Clean Water Act for all sectors of the 

economy, and to working with the Office of Enforcement and Compliance 

Assurance to fully and fairly enforce the law against all sectors, including 

agriculture. 

56. Each year, around 8 million metric tons of plastic waste enters the oceans from 

land. Proper waste management, including storm water management, is an essential part 

of preventing marine debris. Under your leadership, how would you promote the use of 

EPA's authorities under the Clean Water Act to improve the use ofTMDLs, NPDES 

permits, and other authorities to encourage states and municipalities to manage 

wastewater and storm water for debris and litter? 

EPA has made significant progress in working with municipalities in particular to 

improve stormwater management systems. There is certainly more work to do, 

particularly in our urban centers, and tools like integrated and long-term planning 

together with targeted grant funding will help facilitate continued improvements. 

57. How will you address EPA's National Pollutant Discharge Elimination System 

permitting backlog without undermining any environmental protections or subverting the 

goals of the Clean Water Act? 

By making sure bureaucracy does not get in the way of progress. We need to 

strategize, prioritize, plan and implement, and not let isolated goals of perfection 

become the enemy of incremental improvement in the aggregate. 

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58. More than fifty percent of the plastic waste that enters the ocean comes from just five 

rapidly developing economies in Asia. Do you see a role for the EPA in providing 

technical assistance and other recommendations to these and other priority countries that 

are contributing the most plastic waste into the oceans? 

I think EPA should share its technical expertise and problem-solving skills with our 

global partners, within our statutory and budgetary authorities to do so. 

59. Administrator Pruitt has been criticized for spending a disproportionate amount of his 

time meeting with industry and virtually no time with public-interest groups. If 

confirmed, will you commit to meet with and listen to all parties in a balanced fashion? 

If confirmed, I intend to consult with and listen to interested stakeholders with 

multiple perspectives. 

60. If confirmed, do you commit to notifying the Committee of all of the email addresses you 

plan to use upon confirmation and within seven days of using a new email address, 

including any aliases or pseudonyms? Do you commit do conducting all business using 

official email addresses and other means and to refrain from any mediums that are 

outside the Freedom of Information Act's reach? 

If confirmed, 1 commit to notifying the Committee of the e-mail address I use for 

official business. If confirmed, I also commit to following EPA's Records Policy and 

the Federal Records Act. 

61. Factory farming of animals is known contaminate local groundwater with nitrates, 

contributing to harmful algal blooms, hypoxia, and "dead zones" in rivers and coastal 

waters. Harmful algal blooms in particular can contain various toxins that can affect the 

liver, skin, or nervous system, causing a range of health effects, from mild rashes to 

severe illness. To address these health concerns, the EPA co-chairs with NOAA the 

Interagency Working Group on the Harmful Algal Bloom and Hypoxia Research and 

Control Act. 

a. Under your direction, will the EPA to maintain a leadership role on the 

committee? 

Yes. 

b. How will you continue EPA's coordinated work with NOAA and other agencies 

to address HAB and hypoxia events and develop action plans and assessments of 

these situations? 

Should I be confirmed, I look forward to evaluating the existing practices 

and procedures of the working group, which will then inform any 

recommendations I may have. 

Page 25 of26 
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62. If confirmed, do you commit to providing complete and accurate responses to inquiries 

from EPW members in a timely fashion? 

Yes. 

Page 26of26 
527 

Senator BARRASSO. Well, thank you very much, Mr. Ross, and 

congratulations. 

Mr. Wehrum, welcome to the Committee. We look forward to 

your testimony. 

STATEMENT OF WILLIAM WEHRUM, 

PARTNER, HUNTON & WILLIAMS LLP 

Mr. WEHRUM. Thank you, Mr. Chairman. 

I would first like to introduce my family who are here with me 

today. My wife, Cindy, is sitting immediately behind me; my mother, Mary Ann, and my sisters, Lisa and Laura, who, believe it or 

not, are twins, fraternal, of course. 

Senator Carper, my wife came down on 111 this morning and 

will be on 188 tonight, so if you happen to be on the train, please 

be sure to say hello to her. 

Chairman Barrasso, Ranking Member Carper, and members of 

the Committee, thank you for the opportunity to appear before you 

today as the nominee for the position of Assistant Administrator 

for the Office of Air and Radiation at U.S. EPA. I am honored that 

President Trump nominated me for this position. 

I would also like to thank, in particular, Senator Inhofe, for your 

very kind introduction. Under your leadership, previously in 2005, 

my nomination was voted out of this Committee, and I very much 

appreciate that. That meant a whole lot to me. 

President Trump and Administrator Pruitt have set a clear agenda that I intend to implement if confirmed to this position. The 

President has issued executive orders that will eliminate needless 

and burdensome regulations, simplify and streamline compliance 

obligations, and strike a better balance between the twin goals of 

protecting human health and the environment and promoting the 

economic vitality of the nation. 

Administrator Pruitt emphasized three key objectives in his remarks to this Committee during his confirmation hearing. First, we 

are a nation of laws. He explained that EPA’s role is to administer 

those laws faithfully and that the Agency should avoid the temptation to bootstrap its own powers and tools through rulemaking. 

Second, Administrator Pruitt committed that the Agency would 

acknowledge, respect, and promote the critical role of States in implementing Federal environmental laws and in protecting human 

health and the environment. Cooperative federalism is one of the 

cornerstones of the Clean Air Act. In fact, in the very first section 

of the Act, Congress declares that air pollution control at its source 

is the primary responsibility of States and local governments. Administrator Pruitt’s commitment to State involvement carries out 

Congress’s stated intent. 

Third, Administrator Pruitt emphasized the important role that 

the public plays in the regulatory process. He said, ‘‘It is critical 

to me that EPA also truly listen to the diverse views of the American people and learn from them.’’ He rightly stated that ‘‘we simultaneously pursue the mutual goals of environmental protection 

and economic growth,’’ but cautioned that that can only happen if 

EPA listens, listens to the views of all interested stakeholders. 

528 

These are goals and objectives that have been established by our 

leadership. I concur in them, and if confirmed, will do all I can to 

achieve them. 

Mr. Chairman and members of the Committee, thank you again 

for the opportunity to be here, and I would be happy to answer any 

questions you may have today. 

[The prepared statement of Mr. Wehrum follows:] 

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27172.511

William Wehrum 

Partner 

Hunton & Williams LLP 

Bill Wehrum is a partner and the head of the Administrative Law Group at 

Hunton & Williams LLP. Bill's practice focuses on air quality issues including 

regulatory development and related litigation; compliance counseling and 

enforcement defense; legislative advice; and permitting. Prior to joining 

Hunton & Williams, Bill served for two years as Acting Assistant Administrator for Air and 

Radiation at the U.S. Environmental Protection Agency. He has a BS in Chemical Engineering 

from Purdue University and a JD from Widener University. Bill is a member of the District of 

Columbia bar. 
530 


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Statement of William L. Wehrum 

Nominated to Be Assistant Administrator, Office of Air and Radiation 

U.S. Environmental Protection Agency 

Chairman Barrasso, Ranking Member Carper, and members of the Committee. thank you 

for the opportunity to appear before you today as the nominee for the position of Assistant 

Administrator for the Office of Air and Radiation at the U.S. Environmental Protection Agency. 

I am honored that President Trump nominated me for this position. 

As you may know, I previously was nominated in 2005 by President Bush for this 

position. Under Senator Inhofe's leadership, this Committee approved of my nomination at that 

time. I appreciate the opportunity to appear before you again. 

President Trump and Administrator Pruitt have set a clear agenda that I intend to 

implement if confirmed to this position. The President has issued Executive Orders that will 

eliminate needless and burdensome regulations, simplify and streamline compliance obligations. 

and strike a better balance between the twin goals of protecting human health and the 

environment and promoting the economic vitality of the Nation. 

Administrator Pruitt emphasized three key objectives in his remarks to this Committee 

during his confirmation hearing. First, we are a Nation of laws. He explained that "EPA "s role 

is to administer those laws faithfully"' and that the Agency should avoid the temptation to 

"bootstrap its own powers and tools through rulemaking." 

Second. Administrator Pruitt committed that the Agency would acknowledge. respect. 

and promote the critical role of the states in implementing Federal environmental laws and in 

protecting human health and the environment. "Cooperative federalism"" is one of the 

cornerstones of the Clean Air Act. In the very first section of the Act. Congress declares that "air 

- I -
531 


27172.513

pollution control at its source is the primary responsibility of States and local governments.·· 

Administrator Pruitt's commitment to state involvement carries out Congress's stated intent. 

Third. Administrator Pruitt emphasized the important role that the public plays in the 

regulatory process. He said that ''it is critical to me that EPA also truly listen to the diverse 

views of the American people, and learn from them." He rightly stated that "[w]e can 

simultaneously pursue the mutual goals of environmental protection and economic growth." but 

cautioned that "that can only happen if EPA listens- listens to the views of all interested 

stakeholders.'' 

These are the goals and objectives that have been established by our leadership. I concur 

in them and. if confirmed, will do alii can to achieve them. 

Mr. Chairman and members ofthe Committee, thank you again for the opportunity to 

appear before you. I am happy to answer any questions that you may have. 

-2-
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Senate Committee on Environment & Public Works 

Hearing entitled, "Hearing on the Nominations of Michael Dourson, Matthew Leopold, 

David Ross, and William Wehrum to be Assistant Administrators o.ftlte Environmental 

Protection Agettcy, and Jeffery Baran to be a Member of the Nuclear Regulatory 

Commission." 

October 4, 2017 

Questions for the Record for Mr. William Wehrum 

Ranking Member Carper: 

I. For decades, both Republican and Democratic administrations alike have had written 

policies limiting White House contacts with agencies that have investigatory and 

enforcement responsibilities. These policies have recognized that even a simple phone call 

from the White House to an agency inquiring about or flagging a specific matter can upset 

the evenhanded application of the law. I recently learned that Devon Energy, a strong 

political supporter of Administrator Pruitt's, informed the EPA just 5 days after Mr. Pruitt 

was sworn in as Administrator that it was no longer willing to install air pollution 

technology or pay a high penalty to EPA for its illegal air emissions of cancer-causing 

benzene and other chemicals. We also know that Trump family casinos, hotels and golf 

courses have been the subject of EPA enforcement actions for violations of the Clean Air 

Act and Clean Water Act. 

a. Do you agree that it is essential that in making decisions, EPA's OAR must be 

shielded from political influence and spared even the appearance of being subject 

to political influence or considerations? 

If confirmed, I commit to work with Administrator Pruitt and his team to ensure 

strict compliance with all legal and ethical obligations. 

b. Will you commit to restricting communications between OAR and the White 

House staff regarding specific matters under the authority of OAR? 

If confirmed, I commit to work with Administrator Pruitt and his team to ensure 

strict compliance with all legal and ethical obligations. 

c. Will you commit to ensuring the staff of OAR is familiar with those restrictions? 

If confirmed, I commit to work with Administrator Pruitt and his team to ensure 

strict compliance with all legal and ethical obligations. 

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d. Will you commit to advising this Committee within one week if any inappropriate 

communications from White House staff to OAR staff, including you, occur? 

If confirmed, I commit to work with Administrator Pruitt and his team to 

ensure strict compliance with all legal and ethical obligations. 

2. Recently, EPA conducted "anti-leaking" training for its employees 1

• According to EPA 

sources, the briefing stated that "Prohibitions we will discuss do not refer to 

"Whistleblowing". Agency employees have the right to make lawful disclosures to 

anyone, including, for example, management officials, the Inspector General, and/or the 

Office of Special Counsel. Employees may make disclosures to the EPA Office ofthe 

Inspector General through the EPA OIG Hotline at 888-546-8740." This presentation 

evidently failed to note the rights of federal employees have to make disclosures to 

Congress. 

5 U.S.C. § 7211, provides that: The right of employees, individually or collectively, to 

petition Congress or a Member of Congress or to furnish information to either House of 

Congress, or to a committee or Member thereof, may not be interfered with or denied. 

Pursuant to 5 U.S.C. § 2302(b)(8), it is a violation of federal law to retaliate against 

whistleblowers. That law states: Any employee who has authority to take, direct others 

to take, recommend, or approve any personnel action, shall not, with respect to such 

authority ... take or fail to take, or threaten to take or fail to take, a personnel action with 

respect to any employee or applicant for employment because of .... (A) any disclosure of 

information by an employee or applicant which the employee or applicant reasonably 

believes evidences- (i) a violation of any law, rule, or regulation, or (ii) gross 

mismanagement, a gross waste of funds, an abuse of authority, or a substantial and 

specific danger to public health or safety, any disclosure to the Special Counsel, or to the 

Inspector General of an agency or another employee designated by the head of the agency 

to receive such disclosures, of information which the employee or applicant reasonably 

believes evidences a violation of any law, rule, or regulation ... " In addition, pursuant to 

!8 U .S.C. § 1505, it is against federal law to interfere with a Congressional inquiry: 

Whoever corruptly, or by threats or force, or by any threatening letter or communication 

influences, obstructs, or impedes or endeavors to influence, obstruct, or impede the due 

and proper administration of the law under which any pending proceeding is being had 

before any department or agency of the United States, or the due and proper exercise of 

the power of inquiry under which any inquiry or investigation is being had by either 

House, or any committee of either House or any joint committee of the Congress. 

a. If you are confirmed, will you commit to protect the rights of all career employees 

in OAR to make lawful disclosures, including their right to speak with Congress? 

b. Will you commit to communicate employees' whistleblower rights via email to 

all OAR employees within a week of being sworn in? 

If confirmed, I will work closely with EPA Office of Administration and 

1 https://www. washington post .com/ politics/whitehouse/federal-em ployees·a re-ordered-to-attend-anti-lea kingclasses/2 01 7/09/21/032 b40d6-9edd-11 e 7 -b2 a 7 -be 70 b6f98089 _story. html ?utm _term=. e2 bfc5e54d95 

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Resources Management to ensure all OAR employees continue to apprised of 

their rights as federal employees. 

3. In the wake of Hurricane Irma, at least II deaths and numerous injuries have been reported 

in Florida due to accidental carbon monoxide poisoning from gasoline-powered portable 

generators.2 One additional death has also been reported in North Carolina, along with 

other injuries throughout the Southeastern United States. 3 Many of these deaths and 

injuries could have been prevented had stronger safety standards been in place for portable 

gasoline generators. In November 2016, the U.S. Consumer Product Safety Commission 

(CPSC), following years of work on the issue, voted to issue a Notice of Proposed 

Rulemaking (NPRM) to implement a mandatory safety standard for portable generators.4 

Since then, Administrator Pruitt and Acting CPSC Chairman Buerkle have separately 

opined that section 213 of the Clean Air Act precludes CPSC action. 

a. Section 213 of the Clean Air Act is intended to regulate emissions from non-road 

engines or vehicles when the EPA determines that such emissions "are significant 

contributors to ozone or carbon monoxide concentrations in more than I area 

which has failed to attain the national ambient air quality standards for ozone or 

carbon monoxide." In your opinion, would the occasional indoor use of portable 

generators following a power outage be likely to be a significant contributor to 

ambient carbon monoxide concentrations in more than I area that has failed to 

attain the national ambient air quality standards for carbon monoxide? Why or 

why not? 

b. There are currently no areas in the United States that have failed to attain the 

national ambient air quality standards for carbon monoxide, and this has been the 

case since 20105

• As a matter oflaw, could section 213 of the Clean Air Act be 

used to regulate carbon monoxide emissions due to the indoor use of portable 

generators if there are no areas in the United States that fail to attain the national 

ambient air quality standards for carbon monoxide? Why or why not? 

I do not have experience with interpreting or applying CAA § 213 to these 

circumstances. If confirmed, I will work with Administrator Pruitt as 

needed to properly implement this section of the Act. 

4. Your public financial disclosure material lists, among others, several clients such as the 

American Petroleum Institute and others that are trade or other associations that consist of 

individual member companies. For each such association or organization listed on your 

financial disclosure form, please provide a complete list of the individual companies and 

other entities that comprise its members. 

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Page 3 of 56 
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The trade associations listed in my financial disclosure are my clients and not their 

individual members. As such, I do not have current member lists for my trade 

association eli en ts. 

5. In addition to employees or representatives of the trade associations or organizations listed 

as your clients, have you met or otherwise communicated with employees or 

representatives of the companies that are members of the associations or organizations as 

part of your work for the client itself? If so, which ones? 

The trade associations listed in my financial disclosure are my clients and not their 

individual members. I routinely meet with member companies, but do not keep 

comprehensive records of such contacts. 

6. Your ethics agreement states that you ''will not participate personally and substantially in 

any particular matter involving specific parties in which I know a former client of mine is a 

party or represents a party for a period of one year after !last provided service to that 

client, unless I am first authorized to participate, pursuant to 5 C.F.R. 2635.502(d)." 

a. Please provide a list of all such particular matters involving specific parties that 

you will either need to recuse yourself from or seek authorization to participate in. 

For each such particular matter, please also indicate whether you plan to seek 

authorization to participate. 

b. If that list does not include particular matters involving the list of individual 

companies and other entities described in question 4, why not? 

c. 5 C.F.R 2635.502(a) states that 

"where an employee knows that a particular matter involving specific 

parties is likely to have a direct and predictable effect on the financial 

interest of a member of his household, or knows that a person with whom he 

has a covered relationship is or represents a party to such matter, and where 

the employee determines that the circumstances would cause a reasonable 

person with knowledge of the relevant facts to question his impartiality in 

the matter, the employee should not participate in the matter unless he has 

informed the agency designee of the appearance problem and received 

authorization from the agency designee in accordance with paragraph (d) of 

this section." 

Do you agree that your representation of numerous industry clients in litigation to 

repeal or weaken EPA regulations would cause a reasonable person with 

knowledge of the relevant facts to question your impartiality if you are confirmed 

and continue to participate either in the litigation or in an administrative action 

designed to accomplish the identical outcome repeal or weakening of an EPA 

regulation- that the litigation sought to accomplish? Why or why not? 

Attachmeut A is a list of particular matters involving specific parties to 

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which I believe my ethics agreement will apply. If confirmed, I will work 

closely with EPA ethics officials to understand and strictly comply with my 

ethical obligations. 

7. Do you intend to participate in non-public meetings with your former clients or their 

member companies (as applicable) if you are confirmed, even if the meetings are about the 

repeal or weakening of the very same EPA regulations you sought, on behalf of those 

clients, to repeal or weaken through litigation? If so, please explain why this would not 

cause a reasonable person with knowledge of the relevant facts to question your 

impartiality in the matter at hand. 

If confirmed, I will work closely with EPA ethics officials to understand and strictly 

comply with my ethical obligations. 

8. Your Ethics Agreement also states that you will either recuse yourself from or seek 

authorization to participate in "any particular matter involving specific parties in which I 

know the law firm [Hunton & Williams] is a party or represents a party." Please provide a 

list of all the EPA-related particular matters involving specific parties in which Hunton & 

Williams is a party or represents a party. and indicate whether you plan to seek 

authorization to participate in each such matter. 

I do not have a list of all particular matters involving specific parties in which Hunton 

& Williams is a party or represents a party. If confirmed, I intend to ascertain 

Hunton's involvement on a case-by-case basis before becoming involved in any 

particular matter involving specific parties. 

9. On February 28, 2017, President Trump directed EPA and the Army Corps to review and 

possibly rescind or repeal the Clean Water Rule in Executive Order 13776. EPA recently 

ended the public comment process on the first step of a two-step process to repeal the rule 

and replace it with a rule that will protect far fewer sources of drinking water. Individuals 

with first-hand knowledge of the process EPA utilized to prepare its have informed my 

staff that: 

a) When EPA first submitted the proposed repeal rule to OMB, the draft stated that 

the agency would undertake a new cost-benefit analysis as part of the second step 

of its process. 

b) OMB interpreted EPA's first proposal to mean that the rule's repeal would not 

avoid any costs to industry or have any economic impact at all. EPA's political 

staff then directed the career staff to undertake a new economic analysis. In 

response to this direction from OMB, EPA career staff reportedly changed the 

table included in the 2015 rule to a) reflect 2016 dollars instead of2014 dollars, b) 

convert "annual costs incurred" under the Clean Water Rule to "annual costs 

avoided'. due to its repeal and c) convert "annual benefits gained'' under the Clean 

Water Rule to "annual benefits forgone" due to its repeal. This new table was sent 

to OMB on June 8, 2017. 

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c) OMB correctly concluded from EPA's June 8 submittal that repealing the rule 

would cost more in lost benefits than it would save industry in compliance costs. 

On June 13, 2017, presumably to avoid such an admission on the part of EPA, 

EPA career staff were verbally directed by political staff to solve this 'problem' 

by simply deleting the majority of the benefits of the rule from the table andresubmitting it to OMB, which they did6

. 

The direction that was reportedly provided to the EPA career staff to make the various 

revisions to what was submitted to OMB was verbal, not written. If you are confirmed, do 

you commit to ensure that career staff in OAR will receive appropriately documented, rather 

than verbal, direction from political officials before they take action? If not, why not? 

If confirmed, I will work closely with EPA ethics officials to understand and strictly 

comply with my ethical obligations. 

I 0. As Attorney General of Oklahoma, Administrator Pruitt copied and pasted materials sent to 

him by industry onto his own letterhead and sent them to EPA. Similarly, when you last 

served in EPA's air office, language drafted by your old law finn found its way into an 

EPA mercury regulation that you helped write. You also repeatedly prevented EPA 

employees from verifying the public health benefits of reducing mercury exposure. 

a. If confirmed, do you commit that you will not allow industry to exert an undue 

influence on any of the regulatory and policy efforts you will be charged with 

leading? If not, why not? 

b. Do you commit not to censor or exclude the dedicated and knowledgeable career 

EPA staff? If not, why not? 

If confirmed, I will work closely with EPA ethics officials to understand and 

strictly comply with my ethical obligations. 

II. Do you agree to provide complete, accurate and timely responses to requests for 

information submitted to you by any Member of the Environment and Public Works 

Committee? If not, why not? 

Administrator Pruitt has made responsiveness to Congress an important priority. The 

2800 pages of EPA responses provided to Members of the Environment and Public 

Works Committee on display at the nomination hearing is a testament to this 

commitment. Accordingly, I will continue to be a part of EPA's transparent and 

responsive culture. 

6 https://www.epa.gq~sit~~Ql:!_QlQ_QjJJ!es/2017~06/docum§nts/economic analysis proposed step! rule.pdf 

See Table 1 

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12. Recently, EPA announced that Administrator Pruitt would be publishing brief summaries 

of his calendars biweekly, after dozens of Freedom oflnformation Act requests for this 

information as well as a March request by me and my colleagues that he do so. During the 

Obama Administration, the Administrator, regional Administrators and all those serving in 

confirmed roles published their calendars daily7• If you are confirmed, will you commit to 

publishing your calendars daily? If not, why not? 

If confirmed, I will make my calendar available on a timely basis. 

13. In 2006, when you were last nominated to lead the Office of Air and Radiation (OAR), the 

then-Bush Administration requested for FY 2007 $1.33 billion (adjusting to 2017 dollars) 

for State and Tribal Assistance Grants, of which $250 million (in 2017 dollars) was for Air 

and Radiation programs. Earlier this year, the Trump Administration requested for FY 

2018 $597 million, of which $168 million was for Air and Radiation programs. This is 

more than 50% less for the STAG program in general, and almost 113 less for Categorical 

Grants for OAR programs. 

a. Did you support the request for FY 2007, and do you support the request for 

FY 2018? Why, or why not? 

b. lfyou support both the requested levels in FY 2007 and FY 2018, why do you 

believe that a 113 cut to the funding levels in FY 2018 from FY 2017 levels is 

appropriate? 

If confirmed, I will manage OAR's programs within the authorities and 

budget provided by Congress, including STAG grants. 

14. How many legal cases have you filed, or joined others in filing against the EPA, since 

leaving the agency? Please provide a full list with the outcome of each case, including 

those cases in which the court disagreed with your argument, agreed with your argument, 

and those in which the court refused to hear the matter. 

I believe that I have been involved in five cases against EPA that have been decided: 

(l) a challenge to EPA's ElS waiver (dismissed on standing); (2) a challenge to EPA's 

misfueling mitigation rule (dismissed on standing); (3) a challenge to EPA's most 

recent PM2.5 NAAQS (petition denied); (4) a challenge to the Wise Co., TX 

nonattainment area designation for the 2008 ozone NAAQS (petition denied); and (5) 

a challenge to CSAPR (mixed result). I continue to search my files and will update 

this answer if I find more cases. In addition, Attachment l is a table listing all of my 

pending cases against EPA. 

15. You've represented industry in at least thirty-one cases against the EPA since you left 

the agency. Can you name one Clean Air Act regulation that was promulgated by the 

Obama Administration- not a voluntary or grant program that you do support and 

why? If you support more than one, please name these as well. 

Page 7 of 56 
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I represent clients in private practice. It is my legal ethical duty to zealously 

represent their interests. 

16. Delaware is already seeing the adverse effects of climate change with sea level rise, 

ocean acidification, and stronger storms. While all states will be harmed by climate 

change, the adverse effects will vary by state and region. Would you comment on why it 

is imperative that we have national standards to reduce carbon pollution? If you do not 

believe it is imperative, why not? 

If confirmed, my primary responsibility will be to faithfully implement the Clean 

Air Act, including authorities and restrictions applicable to greenhouse gases. 

17. In a per curiam opinion, the U.S. Circuit Court of Appeals for the District of Columbia 

affirmed the Endangerment Finding and the U.S. Supreme Court declined to issue a writ 

of certiorari on the D.C. Circuit's decision. The Endangerment Finding set in motion 

EPA's legal obligations to set greenhouse gas emissions standards for mobile and 

stationary sources, including those established by the Clean Power Plan in August 2015. 8 

During an exchange with Senator Gillibrand during Administrator Pruitt's confirmation 

hearing before the Environment and Public Works Committee, he stated, "I believe that 

the EPA, because of the Mass v. EPA case and the endangerment finding, has obligations 

to address the C02 [carbon dioxide! issue." 

a. Do you agree with Administrator Pruitt's statement? 

b. If the Clean Power Plan is withdrawn, and if confirmed, how will you lead the 

agency to fulfill its legal obligations to address climate change? 

I agree with Administrator Pruitt. If confirmed, my primary 

responsibility will be to faithfully implement the Clean Air Act, including 

authorities and restrictions applicable to greenhouse gases. 

18. EPA policy prohibits the use ofnon-EPA e-mail accounts and instructs employees to: 

"not use any outside e-mail system to conduct oflicial Agency business. If, during an 

emergency, you use a non-EPA e-mail system, you arc responsible for ensuring that any 

e-mail records and attachments are saved in your office's recordkeeping system." When 

last at the EPA, did you ever use personal email to conduct official EPA business? Did 

you ever use an email alias to conduct official EPA business when you last served at the 

agency? Do you commit that if confirmed, you will not use an email alias or use 

personal email addresses to conduct EPA business? 

I do not recall using personal e-mail to conduct official business when last at EPA. 

did not use an e-mail alias to conduct official business when last at EPA. If 

8 htt rs ·f t www _epa gov! cIt mat ec han ge ius '::\;!!U n M a ppea !s~dc *Circuit Muph oldsMepas-ac t ion-red uce-grcenh ousc-gas es-under -c !e!!D_ 

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confirmed, I intend to use my EPA e-mail account to conduct official business. 

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19. Clean car standards save consumers money at the pump and help reduce oil imports. 

1\utomakers are complying with vehicle standards ahead of schedule. If confirmed, will 

you commit to support, defend and enforce EPA's current programs to address 

greenhouse gas emissions from vehicles? 

If confirmed, my primary responsibility will be to faithfully implement the Clean 

Air Act, including authorities and restrictions applicable to greenhouse gases. 

20. For the most part, patients and their families only participate in scientific trials and 

studies once they know their privacy- and any resulting health-related information -will 

remain confidential and secure. If confirmed, do you commit to respecting confidentiality 

agreements that exist between researchers and their subjects? Will you protect the health 

information of the thousands of people that have participated in health studies in the 

past? 

If confirmed, I will comply with appropriate standards to continue the protection of 

sensitive or confidential information. 

21. In December 2007. President Bush's EPA proposed to declare greenhouse gases as a 

danger to public welfare through a draft Endangerment Finding, stating, 

"The Administrator proposes to find that the air pollution of elevated levels of 

greenhouse gas (GHG) concentrations may reasonably be anticipated to endanger 

public welfare ... Carbon dioxide is the most important GHG (greenhouse gas) directly 

emitted by human activities, and is the most significant driver of climate change." 9 

a. Do you agree with these statements, if not, why not? 

b. Did you participate in drafting the proposed Bush Endangerment Finding 

document in any way? If so, how? 

I believe that the climate is changing and that anthropogenic emissions 

contribute to the change. I did not participate in drafting the proposed 

Bush Endangerment Finding document. 

22. When you last served in the EPA OAR office, did the EPA ever propose to disapprove 

state mercury emissions control programs that were stronger than the Clean Air 

Mercury? If so, please provide how many times this happened and what your role was in 

these actions. Please also provide how this fits in Administrator Pruitt's views of 

"'cooperative federalism." 

I do not recall that EPA proposed to disapprove any state program proposed 

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pursuant to the Clean Air Mercury Rule. 

23. The Rule of Law Defense Fund is an affiliate of the Republican Attorneys General 

Association. Have you ever contributed any money or time to the Rule of Law Defense 

Fund? 

No. 

24. Have you ever contributed any money or time to two election fundraising groups, 

Oklahoma Strong PAC and Liberty 2.0 PAC? 

No. 

25. How many legal cases have you filed, or joined others in filing, that involved the 

Renewable Fuel Standard, biofuels or biodiesel since leaving the EPA? Please provide a 

summary of your argument and the outcome of each case, including those cases in which 

the court disagreed with your argument. 

I was counsel of record on three cases related to the RFS (principal clients are 

included in parentheses): (1) a challenge to EPA's ElS waiver (API and the 

Grocery Manufacturers Association); (2) a challenge to EPA's misfueling mitigation 

rule (API); and (3) a challenge to Minnesota's BlO mandate (API, the Auto Alliance, 

the American Fuel and Petrochemical Manufacturers). 

26. Have you ever argued in court, or been part of a legal argument, that the Renewahle Fuel 

Standard, as being implemented by the EPA, will lead to an increase in the overall 

demand for corn, which will lead to an increase in the price of corn? If so, please cite the 

case and the data used for the argument. 

I am not authorized by my clients to discuss relevant cases. 

27. In your 2005 EPW confirmation hearing, you answered a question, with the following, 

"I was barred for I year starting Septcm ber 29, 200 I, from participating in the 

particular matters listed in Attachment A of the memorandum and from taking official 

action on any particular matter in which my former clients, listed in Attachment B, 

were or represented a party to the matter. The ethics memorandum also addressed the 

general rulemakings on which l had represented various clients ... With respect to the 

ethylene MACT rule and the semiconductor MACT rule, he [Kenneth J. Wernick, 

EPA's then Alternate Agency Ethics Official] concluded that it would be prudent for 

me not to handle these matters during my first year at EPA. Subsequent to that time, 

there was no bar to my participating as an EPA official in these rulemakings ... In 

accordance with the ethics memorandum referenced above, I refrained for l year 

starting September 29, 200 l, from participating in the particular matters identified by 

the memorandum and from taking official action with respect to any particular matter 

involving the entities listed in the memorandum. I also did not participate in the 

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ethylene and semiconductor MACT rules in my tirst year at EPA." 10 

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a. Please provide a full list of the cases you filed, joined others in filing, or 

participated in some way related to the ethylene and semiconductor MACT 

rules prior to you joining the EPA in 200 I. Please include any other work that 

you may have done while employed at Latham and Watkins- or any other 

organization - prior to coming to the EPA in 200 I that was related to the 

ethylene and semiconductor MACT rules. 

b. What led Kenneth J. Wernick, EPA's then Alternate Agency Ethics Official to 

conclude it wouldn't "be prudent" for you to handle the ethylene MACT rule 

and the semiconductor MACT rule during your first year at EPA? 

c. In 2001, what other issues and rulemakings did you have to recuse yourself for 

one year to meet the ethical standards set by the EPA? 

Prior to and upon joining EPA in 2001, I sought, obtained, and strictly 

followed advice from EPA's ethics officials as to my ethical obligations 

related to my prior work in private practice. My prior ethics agreement is 

a matter of public record. 

28. How many legal cases have you filed, or joined others in filing, since leaving the EPA 

that challenged rules the Obama EPA had to re-write because the courts said the original 

rules written by the Bush Administration were illegal? 

To my knowledge, I have been involved in three cases challenging rules that EPA 

issued on remand from court decisions on Bush Administration air rules. 

29. On July 8, 2003, JeffHolmstead, then-EPA Assistant Administrator for Air and 

Radiation provided the following remarks in his written testimony to the House Energy 

and Air Quality Subcommittee of the Energy and Commerce Committee, 

·'Clear Skies would also reduce mercury emissions from power plants. EPA is required to 

regulate mercury because EPA determined that mercury emissions from power plants 

pose an otherwise unaddressed significant risk to health and the environment, and 

because control options to reduce this risk are available." 11 At the time Mr. Holmstead 

provided these remarks, you were serving as his chief counselor within the EPA OAR 

office. 

a. Did you agree at the time with Mr. Holmstead's determination, if so why? If 

not, why not? 

b. Did you ever provide legal counsel to Mr. Holmstead, or others within the EPA, 

that helped provided the legal basis for these remarks? 

c. Do you agree with Mr. Holmstead's remarks today? 

I believe Mr. Holmstead was referring to Administrator Browner's 1999 

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"appropriate and necessary" determination, which was still in effect at the 

time. That determination, as amended in the Mercury and Air Toxics 

Rule, was determined to be illegal by the US Supreme Court. 

30. On July 8, 2003, JeffHolmstead, then-EPA Assistant Administrator for Air and 

Radiation provided the following remarks in his written testimony to the House Energy 

and Air Quality Subcommittee of the Energy and Commerce Committee: 

"Mercury, a potent toxin, can cause permanent damage to the brain and nervous system, 

particularly in developing fetuses when ingested in sufficient quantities. People are 

exposed to mercury mainly through eating fish contaminated with methylmercury ... EPA 

estimates that 60% of the mercury falling on the U.S. is coming from current man-made 

sources. Power generation remains the largest man-made source of mercury emissions in 

the United States ... Mercury that ends up in fish may originate as emissions to the air. 

Mercury emissions are later converted into methylmercury by bacteria. Methylmercury 

accumulates through the food chain: fish that eat other fish can accumulate high levels of 

methylmercury". 12 At the time Mr. Holmstead provided these remarks, you were serving 

as his chief counselor within the EPA OAR office. 

a. Did you have any involvement in the drafting of these remarks? If so, what was 

your involvement? 

b. Did you agree at the time with Mr. Holmstead's remarks, if so why? If not, 

why not? 

c. Do you still agree with Mr. Holmstead's remarks today? If not, why not? 

I do not recall being involved in drafting Mr. Holmstead's remarks. I 

believe that, for the most part, mercury emissions from power plants are 

dispersed widely in the global atmosphere. I believe that global mercury 

emissions inventories have significantly changed since my prior time at 

EPA. Therefore, I cannot speak to his comments related to domestic and 

global emissions inventories. I believe his comments about the movement 

and transformation of mercury in the environment are correct. 

31. In the White Stallion Energy Center v. EPA, February 20/2, industry argued, ''the record 

does not support EPA's findings that mercury, non-mercury HAP metals, and acid gas 

HAPs [hazardous air pollutants] pose public health hazards." 13 Do you agree with this 

statement? Did you have any involvement with this case, if so, please explain. 

I believe that comments were submitted to the record in this rulemaking 

demonstrating significant flaws in EPA's exposure and risk assessment. I was not 

counsel of record in this case. 

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32. On Aprill7, 2012, Dr. Jerome Paulson, Chair, Council on Environmental Health, 

American Academy of Pediatrics, testified before the EPW Committee, stating, "Methyl 

mercury causes localized death of nerve cells and destruction of other cells in the 

developing brain of an infant or fetus. It interferes with the movement of brain cells and 

the eventual organization of the brain ... The damage it [methylmercury] causes to an 

individual's health and development is permanent and irreversible .... There is no 

evidence demonstrating a "safe" level of mercury exposure, or a blood mercury 

concentration below which adverse effects on cognition are not seen. Minimizing 

mercury exposure is essential to optimal child health." 14 

a. Do you agree with the American Academy of Pediatrics' finding on the 

importance of minimizing mercury exposures for child health? If not, please 

cite the scientific studies that support your disagreement. 

b. Do you agree the record supports EPA's findings that mercury, non-mercury 

hazardous air pollutant metals, and acid gas hazardous air pollutants emitted 

from uncontrolled power plants pose public health hazards? If not, why not? 

I am not familiar with Dr. Paulson's testimony. I believe that comments 

were submitted to the record in this rulemaking demonstrating significant 

flaws in EPA's exposure and risk assessment. 

33. On July 8, 2003, JeffHohnstcad, then-EPA Assistant Administrator for Air and 

Radiation provided the following remarks in his written testimony to the House Energy 

and Air Quality Subcommittee of the Energy and Commerce Committee, 

''We have not developed methodologies for quantifying or monetizing all the expected 

benefits of Clear Skies ... These estimates [for Clear Skies] do not include the many 

additional benefits that cannot currently be monetized but are likely to be significant, 

such as human health benefits from reduced risk of mercury emissions, and ecological 

benefits from improvements in the health of our forests, lakes, and coastal waters." 15 At 

the time Mr. Holmstead provided these remarks, you were serving as his chief counselor 

within the EPA OAR office. 

a. Did you have any involvement in the drafting of these remarks? If so, what was 

your involvement? 

b. Did you agree at the time with Mr. [[olmstead's remarks, if so why? If not, 

why not? 

c. Do you agree with Mr. Holmstead's remarks today that it is currently difficult, 

or impossible. to monetize the reduced risk of human health and ecological 

benefits from reducing mercury emissions from power plants? If so, please 

explain. If not, why not? 

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I do not recall being involved in drafting Mr. Holmstead's testimony. I 

believe that EPA was not able in 2003 to monetize all benefits associated 

with reducing mercury emissions. I do not know the current state of EPA's 

knowledge. 

34. In 2005 GAO report that reviewed EPA's cost-benefit analysis for the Clean Air Mercury 

Rule, which you have testified you were heavily involved in writing, GAO identified, 

"four major shortcomings in the economic analysis underlying EPA's proposed mercury 

control options that limit its usefulness for informing decision makers about the 

economic trade-offs of the different policy options." 16 

a. Can you explain the cost-benefit analysis used for the proposed Clean Air 

Mercury Rule and why it was used? 

b. Can you explain why the GAO found short-comings with this approach? 

c. Do you agree that co-benefit pollution reductions should be considered when EPA 

is quantifying the benefits and costs of regulations? If not, why not? 

d. While you were at EPA, did the agency ever use co-benefits to justify a clean 

air rule and has this approach ever been used in the past? 

I do not recall being involved in preparing the cost-benefit analysis for the 

Clean Air Mercury Rule. If confirmed, I intend to address the question of 

how co-benefits should be considered in cost-benefit analyses. I cannot 

prejudge the outcome because any such analysis would be an integral part 

of informal legislative rulemaking. 

35. You were substantially involved in EPA's proposal and adoption ofthc Clean Air 

Mercury Rule and accompanying Delisting Rule. In 2005, for your EPW confirmation 

hearing you were asked the following question for the record: "With regard to trading of 

mercury, in your view, would it have been legally acceptable for EPA, taking into 

account the requirements of the Clean Air Act, to propose and adopt a facility specific 

mercury MACT that did not allow trading?" You answered, "After considering the 

utility unit emissions that would remain following imposition of the requirements of the 

Act, EPA determined that it was neither appropriate nor necessary to regulate utility units 

under section 1 12 of the Clean Air Act. Once EPA made that determination, it would not 

have been legally appropriate for EPA to issue a MACT standard." Three years later, the 

D.C. Circuit vacated the EPA's decision to de list power plants as a source under Section 

112. Six years later under the Obama Administration, the EPA issued the Mercury and 

Air Taxies Rule to address mercury and air toxic emissions from power plants under the 

Section 112 of the Clean Air Act. 

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a. Did you disagree with the court's ruling and legal reasoning against the EPA's 

actions while you were at the agency on mercury and air toxic power plant 

emissions? Do you continue to disagree today? 

b. Do you still hold the position that it is not "appropriate nor necessary" for the 

EPA to regulate utility units under Section 112 ofthe Clean Air Act and 

therefore, still agree it is not legally appropriate for EPA to issue a MACT 

standard, as the EPA did through the Mercury and Air Taxies Standard? If so, 

please explain. 

c. If you do not agree that EPA has met the "necessary and appropriate" criteria 

found in Section ll2(n), what is your understanding of what that would mean 

for the Mercury and Air Taxies Rule? 

I respect the court's decision with regard to the Clean Air Mercury Rule. I 

also respect the US Supreme Court's determination that the "appropriate 

and necessary" finding relied upon in the Mercury and Air Toxics Rule 

was illegal. 

36. The US Supreme Court has expressly declined to consider whether EPA should have 

chosen some other mechanism "under section 112" in regulating power plant mercury 

and all the other HAPs emitted by the industry. What is your position on that precedent? 

The Supreme Court chooses which areas they should consider providing judgement 

on when issuing decisions and which areas they decline to consider. I cannot infer 

the intent of the court from their decision not to consider this one specific issue. 

37. Do you agree that the EPA's recent consideration of the costs of the Mercury and Air 

Taxies Rule shows that the agency has met the "necessary and appropriate" criteria 

Congress provided under ll2(n} to direct the EPA to regulate power plant mercury (and 

other air toxic) emissions under Section 112, and more specifically under Section 112(d)? 

If not, why not? 

If confirmed, I likely will be involved in assessing til is question. I cannot prejudge the 

outcome. 

38. The Edison Electric Institute (EEl), the association that represents all U.S. investor-owned 

electric companies, has told my staff that, to their knowledge, about five facilities received 

an approval from the EPA to operate for up to an additional year, which was through April 

2017. According to EEl, to their knowledge all of their member companies have fhlly 

implemented the Mercury and Air Toxics Standard Rule. EPA staff has reported to my 

staff something similar. The Mercury and Air Taxies Rule protects our children from 

harmful mercury and air taxies pollution; and by industry accounts is already being met 

with technology that is already bought, paid for and running on almost all our power plants. 

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a. Do dispute reports that nearly all covered facilities are already in compliance with 

the Mercury and Air Taxies Standard? If so, please explain. 

b. According to a recent report by Bloom berg New Energy Finance Report and the 

Business Council for Sustainable Energy, "consumers now pay 3% less per 

kilowatt-hour for electricity than in 2007." 17 This means the near universal 

compliance ofthc Mercury and Air Taxies Rule has been achieved without 

significant impacts to electricity reliability or affordability, in fact electricity 

prices have gone down. Do you agree? If not. why not? 

c. Even though industry has achieved near universal compliance with the Mercury 

and Air Taxies Standards and electricity prices have gone down, not up, 

Administrator Pruitt is currently reviewing whether it is "appropriate and 

necessary" to issue the standards in the first place. Do you agree that the EPA 

should be conducting this review, if so, why? 

d. If the EPA determines the agency has not met the "necessary and appropriate" 

criteria found in Section 112(n), and revokes the Mercury and Air Taxies Rule, 

what does that mean for all the pollution control technology that has been 

bought, paid for and running on our power plants helping the industry be in full 

compliance of the rule? 

c. When you were last at the EPA, or after, do you know of any instances when a 

power plant bought and installed air control technology and decided not to run the 

technology? If so, please explain the instance. Please include in your explanation 

if there were any impacts to downwind states or to air pollution levels. 

If confirmed, I likely will be involved in assessing the question of how to 

appropriately respond to the US Supreme Court's remand of the MATS 

"appropriate and necessary" determination. I cannot prejudge the outcome 

of that assessment. I will note that MATS imposed substantial costs on 

electric power generators. The fact that power prices have declined in recent 

years does not necessarily mean that MATS did not impose substantial 

incremental costs. 

39.1n a 2016 Law 360 article, you are quoted as saying, "The reason this [the Mercury and 

Air Taxies Standards Rule] was such a big issue for us is because by EPA's own analysis, 

if you look at the benefits generated by the hazardous air pollutant reductions this rule 

would achieve, the costs vastly outweigh the benefits. So from our perspective, it's a 

regulation that made no sense and wasn'tjustified." 18 1n April2017, the EPA asked the 

D.C. Circuit Court of Appeals to delay oral arguments scheduled the Mercury and Air 

Taxies Standards (MATS) as it reviews the rule. 

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a. It is clear from this statement you already have a formed view of the validity of 

the Mercury and Air Toxics Standard going into the agency. Will you commit 

to this Committee that you will recuse yourself from the review and any 

possible rewriting of the Mercury and Air Toxics Rule? If not, why not? 

b. Do you continue to believe the Mercury and Air Toxics Standards is a 

regulation that made no sense and wasn't justified? If so, why? 

The quantifiable monetized benefits of the HAP reductions predicted to 

occur under MATS measured only a few million dollars. I understand that 

EPA has recalculated the benefits attributable to MATS in response to the 

Supreme Court remand. I am not familiar with the new estimates. If 

confirmed, I intend to consider them objectively. 

40. Will you commit, that if confirmed, you will not act to weaken the Mercury and Air 

Toxics Standards, if not, why not? 

I cannot prejudge any decision that might be made by EPA ifl am confirmed. 

41. This year, you represented the American Petroleum Institute as an intervenor in defense of 

Administrator Pruitt's 90-day stay of oil and gas pollution standards, which the D.C. 

Circuit found violated the Clean Air Act. In my office, you refused to recuse yourself from 

participating in this rule, is that still true and how do you justify that, if confirmed, you will 

come into the EPA as impartial regulator as it relates to this issue? Do you agree with the 

court's decision, and why not? 

Comprehensive rules of ethics govern the transition from private practice to 

government service. If confirmed, I will work closely with EPA ethics officials to 

understand and strictly comply with my ethical obligations. 

42. Section 109 of the Clean Air Act is very clear. It requires EPA to review the NAAQS for 

six common air pollutants including ground-level ozone, particulate matter, sulfur 

dioxide, nitrogen dioxide every 5 years. The Clean Air Act requires EPA to set these 

standards that "are requisite to protect the public health," with "an adequate margin of 

safety," and secondary standard necessary to protect public welfare. 

a. If eon!lrmed, will you continue to hold to the five-year National Ambient Air 

Quality Standards review time period that the Clean Air Act requires of the 

EPA? 

b. The science was clear that the 2008 ozone standard was not protecting public 

health, so EPA was required to Act. Is that not your understanding of the Clean 

Air Act? 

c. If confirmed, will you commit to not further delay the implantation of the 2015 

ozone NAAQS? If not, why not? 

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d. Do you agree with Justice Scalia's opinion in Whitman v. American Trucking 

Associations that it is "fairly clear that [the Clean Air ActJ does not permit the 

EPA to consider costs in setting the standards" and if so, will you commit not to 

include consider costs when setting the National Ambient Air Quality 

Standards? If you do not agree, why not? 

If confirmed, I will endeavor to meet all statutory deadlines. I am not 

familiar with the record for the 2015 ozone NAAQS decision, so cannot 

comment on the decision to change the standard. I respect all US Supreme 

Court decisions. 

43. In 2006, while you served as Acting Assistant Administrator for Air, the EPA proposed to 

eliminate lead as a criteria pollutant under the Section 109 Clean Air Act National 

Ambient Air Quality Standard (NAAQS) process. Did you have any involvement in this 

proposal? If so, please explain. 

Yes, I was involved in developing that proposal. CAA § l08(a)(l)(B) states that 

ambient levels of a criteria pollutant should "result[] from numerous or diverse 

mobile or stationary sources." Information at the time indicated that there were few 

industrial sources oflead emissions and that lead emissions from mobile sources had 

been virtually eliminated. The proposal asked for comment on whether lead 

continued to meet the§ 108(a)(l)(B) criterion. 

44. Like you, I am an avid runner. In Delaware during the summer, we often have code 

orange days warning about the high levels of ozone for that day. Much of Delaware's 

ozone pollution is coming across the state boundary from upwind states. 

a. Can you describe how high levels of ozone could damage my lungs if I were to 

take a long run during a code orange day? 

b. Do you agree that ground-level ozone is a dangerous pollutant that causes 

respiratory and cardiovascular harm? If not, on what basis do you disagree? 

c. If confirmed, how would you direct states to work together to reduce ozone 

pollution? 

Inhaling too much ozone can cause a wide range of adverse cardiovascular 

effects. CAA §§ ll0(a)(2)(D) and 126 arc designed to address interstate 

transport (i.e., emissions from upwind states that significantly contribute to 

downwind nonattainment). 

45. Clean Air Act section 11 O(a)(2)(D)(i)(l), also known as the "Good Neighbor" provision, 

requires that state implementation plans to address air pollution "contain adequate 

provisions prohibiting, consistent with the provisions of this subchapter, any source or 

other type of emissions activity within the State from emitting any air pollutant in amounts 

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which will contribute significantly to nonattainment in, or interfere with maintenance by, 

any other State with respect to any such national primary or secondary ambient air quality 

standard." Under this provision of the Clean Air Act, "[w]henever the Administrator finds 

that the applicable implementation plan for any area is substantially inadequate ... to 

mitigate adequately[] interstate pollutant transport ... or to otherwise comply with any 

requirement of this chapter, the Administrator shall require the State to revise the plan as 

necessary to correct such inadequacies." 

a. Do you support the "Good Neighbor Provision" in the Clean Air Act and agree 

that this provision does not "encroach upon state sovereignty"? If not, why? 

b. If confirmed, do you commit to fu!ly apply and enforce the Good Neighbor 

provision? 

CAA § 110(a)(2)(D) describes one of many elements that must be included in 

an approval State Implementation Plan. My hope is that more states address 

this obligation in the first instance so that US EPA does not need to make 

findings of substantial inadequacy. Ir confirmed, my goal is to faithfully 

implement all aspects of the Clean Air Act. 

46. Currently, under the Clean Air Act section II O(a)(2)(D)(i)(I), also known as the "Good 

Neighbor" provision, Delaware has sent four petitions to the EPA that identify facilities in 

other states that are emitting air pollution that are significantly contributing to Delaware's 

air quality and impacting Delaware's ability to maintain or be in attainment for the 2008 

national ambient air quality standards (NAAQS) for ozone and the 2015 ozone NAAQS. 

The petitions are for: l) Brunner Island facility's electric generating units located ncar 

York, Pennsylvania; 2) Homer City Generating Station's electric generating units located in 

Indiana County, Pennsylvania; 3) Harrison Power Station's electric generating units located 

near Haywood, Harrison County, West Virginia; and 4) Conemaugh Generating Station's 

electric generating units located in Indiana County, Pennsylvania. In addition, Maryland 

has filed a petition that requests EPA make a finding that 36 electric generating units 

located in the states of Indiana, Kentucky, Ohio, Pennsylvania, and West Virginia are 

emitting air pollutants that significantly contribute to nonattainment or interfere with 

maintenance of the 2008 and the 2015 ozone NAAQS in Maryland. The EPA has granted 

itself six months extension on every petition and has done nothing after that. All of the 

extensions have long since expired. 

a. If confirmed, will you commit to promptly act on Good Neighbor petitions so 

states, like Delaware and Maryland, can protect their citizens from upwind 

pollution in neighboring and distant states? If not, why not? 

b. If confirmed, will you support, defend and enforce EPA's Good Neighbor 

provisions to address air pollution that crosses state borders? If not, why not? 

c. In some of these situations, like the Harrison Power Station near Haywood in 

West Virginia, the power plant in question has the needed technology on the 

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facility to help reduce ozone pollution in downwind Delaware and West Virginia 

ratepayers are already paying for the technology, but the pollution control isn't 

running. If conlirmed, what will you do to ensure pollution control technology 

already on facilities runs to ensure downwind states have clean air? 

d. If conlirmed, will you fully implement the Cross State Air Pollution Rules? 

e. If the Mercury and Air Toxics Rule is revoked, do you expect there will be an 

increase in upwind ozone and particulate pollution and have an impact on 

downwind states? If so, please explain. If not, why? 

I think your question relates to CAA § 126 and not to§ 110(a)(2)(D). I am 

not familiar with the specific petitions described in this question. But, I will 

note that CSAPR and the CSAPR update rule were intended to address 

interstate transport under§ 110(a)(2)(D), such that there should not be a 

need or ,justification for § 126 petitions addressing the same plants, 

pollutants, and standards. If confirmed, I will endeavor to meet all CAA 

deadlines and my goal will be to faithfully implement all aspects of the CAA. 

47. Just last month, you argued against an Obama Administration Occupational Safety and 

Health Administration indoor air rule that protects construction workers against silica dust, 

a type of dust that is linked to cancer and lung disease. During your arguments, you are 

quoted as saying, "People are designed to deal with dust- people are in dusty 

environments all the time, and it doesn't kill them," 19The American Industrial Hygiene 

Association has stated that delaying the full enforcement of this rule will put- and this is 

their words, quote "2.3 million workers at greater risk to exposure, especially the 

construction industry- the backbone of our economy" 

a. Please provide the scientific studies that provided the basis for your argument in 

this case. 

b. When you stated "people are designed to deal with dust," what did you mean by 

that statement? 

c. When you were last in the EPA, did you ever work on a rule was deemed later to 

ignore all of the science dealing with particle matter pollution? 

d. Do you agree that there is robust science linking small particle pollution to 

negative health impacts, even death? If so, why is the science here different than 

for silica pollution? 

The silica case dealt with the unique toxicological properties of silica and not 

with the pollutant "particular matter" that is regulated by EPA. The quote 

in this question was taken out of the context of a broader argument related to 

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the question of whether there is an exposure threshold for respirable silica 

below which significant adverse health effects should not be expected to 

occur. The silica case remains an active matter and I am not authorized by 

my clients to say more. 

48. Do you agree with President Trump's decision to withdraw the United States from the 

International Paris Climate Accord? If so, please explain. 

President Trump is the Nation's ChiefExeeutive. I believe it was within his authority 

to withdraw. I respect his decision. 

49. In part of his justifications for withdrawing from the Paris Climate Agreement, President 

Trump stated the Paris Accord could, "cost America as much as 2.7 million lost jobs by 

2025 according to the National Economic Research Associates (NERA)."10 This economic 

statistic and others linked to the NERA study were also distributed in White House 

materials as reasons the President was deciding to withdraw from the Paris Accord. Soon 

after the President's speech, NERA stated, "In a set of talking points distributed by the 

White House in conjunction with its announcement of the US withdrawal from the Paris 

Agreement, the Trump Administration selectively used results from a NERA Economic 

Consulting study, "Impacts of Greenhouse Gas Regulations on the Industrial Sector." ... 

Use of results from this analysis as estimates of the impact of the Paris Agreement alone 

mischaracterizes the purpose ofNERA's analysis, which was to explore the challenges of 

achieving reductions from US industrial sectors over a longer term. Selective use of results 

from a single implementation scenario and a single year compounds the 

m ischaracterization. "21 

a. In light ofthe NERA statement, do you think the President misspoke when he 

wrongly cited information from the NERA study in his Paris speech? If not, why 

not? 

b. If confirmed, will you commit that you will not distort the NERA study- or any 

other economic study to justify the U.S. withdrawing from the Paris Climate 

Accord or to justify the elimination or delay of climate policies? 

c. After the President's Paris Climate Accord speech, MIT's Joint Program on the 

Science and Policy of Global Change issued a statement stating the President's 

characterization of their analysis of the Paris Accord to be misleading.12 If 

confirmed, will you commit that you will not distort the climate science studies to 

justify the U.S. withdrawing from the Paris Climate Accord or to justify the 

elimination or delay of climate policies? 

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I am not familiar with the NERA study, so I cannot assess NERA's 

comments. If confirmed, my goal would be not to "distort" anybody's 

statements. 

50. In a Law360 interview. you were asked, "What is the most challenging case you have 

worked on and what made it challenging?" You responded, "Without a doubt, it would be 

Massachusetts v. EPA. I was at the EPA at the time, working as counsel to the assistant 

administrator for air, JeffHolmstead."23 Please explain in detail, what your involvement 

was while in the EPA regarding regulations that led to, and the agency's defense of the 

Massachusetts v. EPA case. 

There were no regulations that led to the Mass v EPA decision. The decision under 

review was EPA's denial of a citizen petition asking EPA to regulate GHG emissions 

from motor vehicles. OAR was responsible in the first instance for preparing the 

proposed and final denial. OAR staff- including myself- provided support to the 

government litigation team while the case was pending in the DC Circuit and the US 

Supreme Court. 

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Senator Cardin 

51. On December 15,2016, EPA extended by six months the deadlines to respond to petitions 

submitted by the state of Maryland under section 126 of the Clean Air Act. The petition 

from Maryland requests that EPA make a finding that 36 electric generating units located 

in the states of Indiana, Kentucky, Ohio, Pennsylvania, and West Virginia are emitting air 

pollutants that significantly contribute to nonattainment or interfere with maintenance of 

the 2008 and the 2015 ozone NAAQS in Maryland. On September 27, 2017, the State of 

Maryland filed a complaint in the United States District Court of the District of Maryland 

against the EPA because of the lack of response in regard to the 2016 Good Neighbor 

petition. 

Will you commit to urge the EPA to approve the petition and enforce the air pollution 

controls already in place in Maryland at upwind out-of-state facilities that directly impede 

efforts to attain and maintain tederal health-based air quality standards in Maryland? 

I cannot commit at this time to take any action for which I might be responsible if 

confirmed to be AA for OAR. I will note that CSAPR and the CSAPR update rule 

were intended to address interstate transport under§ 110(a)(2)(D), such that there 

should not be a need or justification for§ 126 petitions addressing the same plants, 

pollutants, and standards. If confirmed, and if the issues have not yet been resolved, 

I will look closely at the intersection of Maryland's § 126 petition with the CSAPR 

rules. 

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Senator Duckworth: 

52. The Renewable Fuel Standard (RFS) program passed Congress with broad bipartisan 

support and was signed into law by President George W. Bush because it strengthens our 

nation's energy independence and security. The RFS supports rural communities and 

American farmers, while reducing greenhouse gas emissions. In my home State of Illinois 

alone, the RFS has helped create 4000 jobs and more than $5 billion in economic impact. 

I am concerned Administrator Pruitt, who reassured Congress that he would execute the 

program as Congress intended, will break his promise and implement the law in such a 

way as to limit or cap the growth in renewable fuels- directly violating the RFS 

program's statutory goals to increase American energy independence and security 

through increased production ofbiofuels. As the U.S. Environmental Protection Agency 

(EPA) has repeatedly affirmed, any policy that decreases or limits growth in biofuels is 

inconsistent with the statutory goals that Congress enshrined in the law. 

Do you believe that Congress intended the RFS to promote long-term growth in all 

biofuels fuels, including cellulosic ethanol? If confirmed, will you commit that EPA will 

issue Renewable Volume Obligations that increase production of renewable fuels across 

the board? 

The RFS clearly was intended to promote the growth of a wide. range of biofuels, 

including cellulosic ethanol. I cannot commit at this time to take any action for 

which I might be responsible if confirmed to be AA for OAR. If confirmed, my 

intention is to faithfully implement all aspects of the CAA, including the RFS. 

53. During your nomination hearing you stated that you will seek guidance from EPA ethics 

officials on whether or not you should recuse yourself from issues for which you have 

previously been engaged in. However, as a regulator and a public servant, you can and 

should use your own discretion on recusal to avoid even the appearance of conflict of 

interest. 

If confirmed, will you commit to recusing yourself on any issue related to biofuels or the 

renewable fuels standard given your past work on behalf of industry interests? What 

other steps will you take to guarantee that your financial and political interests do not 

influence your work on the RFS? 

Comprehensive rules of ethics govern the transition from private practice to 

government service. These rules address both real conflicts and appearances of 

impropriety. If confirmed, I will work closely with EPA ethics officials to 

understand and strictly comply with my ethical obligations. 

54. Will you submit for the record a full list describing any action you performed in your 

professional career related to the RFS program and identify the client or clients on whose 

behalf you were acting for each action? 

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I was counsel of record on three cases related to the RFS (principal dients are 

included in parentheses): (1) a challenge to EPA's ElS waiver (API and the Grocery 

Manufacturers Association); (2) a challenge to EPA's misfueling mitigation rule 

(API); and (3) a challenge to Minnesota's BtO mandate (API, the Auto Alliance, the 

American Fuel and Petrochemical Manufacturers). I also was responsible for RFS 

implementation during my prior tenure at EPA. 

55. The Mercury and Air Toxics Rule, or MATS, is an EPA success story about protecting our 

most vulnerable our children. After decades of delayed action, EPA implemented the 

MATS rule to protect our children and our pregnant women from our country's number 

one source of unregulated mercury and other air toxic pollution: power plants. 

Today, EPA says very few power plants in the country are not meeting the MATS 

pollution reduction timelines. Dr. Goldman, a world-renowned epidemiologist, 

pediatrician and Dean of the School of Public Health at George Washington University, 

testified earlier this year that we are seeing the public health benefits of MATS faster 

than predicted. Simply put, compliance for industry ha~ been easier than opponents of 

this rule predicted and children are better protected than doctors expected a real winwin that would never have occurred had corporate special interests prevailed in killing 

this critical public health rule. 

Despite these successes, you continue to lead industry lawsuits against the MATS Rule, 

falsely claiming that EPA has yet to prove it is appropriate and necessary to regulate 

mercury and air toxic emissions from power plants, a decision made almost two decades 

ago. You have argued that the price of our children's mental development is worth less 

than running pollution control technology that is already bought, paid for and running on 

our power plants. 

How can you assure us you will be impartial- you will choose our children over industry 

when it comes to the Mercury and Air Taxies rule? How can you assure the American 

public that you will do the right thing to protect the children of Illinois and the children of 

all Americans? 

This question is premised on two factual inaccuracies. First, I do not "lead industry 

lawsuits against the MATS Rule." I was not counsel of record in the challenges to 

MATS and am not counsel of record in challenges to EPA's renewed "appropriate 

and necessary" finding. Second, industry petitioners in the MATS case did not 

make "false claims" related to the "appropriate and necessary" finding. In fact, the 

US Supreme Court determined that that finding was unlawful, which supported the 

petitioners' claims in this regard. Having said that, I have a deep interest in 

protecting public health and the environment, including children's health. 

56. As you know Administrator Pruitt, like Secretary Zinke and former Secretary Price have 

spent millions of dollars combined flying on private jets across the country. This is a gross 

waste of taxpayer dollars. 

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Yes or no, us a ta,"{payer, do you approve of Administrator Pruitt's travel practices on the 

public dime, and will you commit to utilizing commercials tlights in your position? 

I am not familiar with Administrator Pruitt's or Secretary Zinke's tr.wel history, so 

cannot speak to this aspect of your qm~stion. Should I be confirmed, I intend to utilize 

commercial flights to carry out my official duties. 

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Senator Ernst: 

57. Administrator Pruitt has made engagement with rural America a priority and he has 

expressed particular concern over how EPA regulations, such as the Waters of the United 

States (WOTUS) rule, impact these local communities. In cases like WOTUS, the previous 

EPA did not fully analyze the costs associated with the regulation, particularly for rural 

communities. At the same time, the benefits of this rule, and others, were often overstated. 

How will you work to assure transparency when documenting the costs and benefits 

associated with EPA actions under your office? 

Costs can be considered in setting some, but not all, Clean Air Act rules. But, even 

when costs cannot be considered, it is important to prepare a comprehensive 

regulatory impact analysis so that the full costs and benefits of a rule are known. If 

confirmed, I will work hard to ensure that costs and benefits are accurately assessed 

and appropriately considered. 

58. At multiple times over the course of your career you have represented clients such as API, 

GMA and others in cases intended to undermine the RFS. The questions you have argued 

in those cases are relevant to the current RVO rule making for 2018 and 2019, as well as 

those statutorily required going forward. Additionally, they are relevant to the regulatory 

decisions related Reid Vapor Pressure waivers, biofuel pathway approval, and topics you 

will have oversight of, if confirmed. Given this, will you recuse yourself from RFS 

rulemaking, administering the program or some portions of the program if confirmed, and 

if you do, who will administer the RFS? 

I was counsel of record in cases challenging EPA's ElS waiver, EPA's misfueling 

mitigation rule, and Minnesota's BlO mandate. These cases have all been decided and 

have no direct bearing on RFS implementation going forward. If confirmed, I do not 

believe it will be necessary or appropriate for me to recuse myself from RFS matters, 

although I will continue to work with EPA ethics officials to make sure that l fully 

comply with my obligations, and my intention is to faithfully implement all aspects of 

the CAA, including the RFS. 

59. If you are confirmed, will you commit to have an open door policy for all interest groups, 

including those representing biofuels, to ensure that their perspectives are taken into 

consideration by yourself, the Administrator, and the rest of political leadership at EPA? 

If confirmed, I fully intend to have an open door policy on all issues. 

60. Do you believe it is fair and appropriate to use only the input of parties regulated by the 

Clean Air Act when making regulatory decisions? 

No, many parties that are not sub.ject to EPA's rules are affected by the rules and 

should have the opportunity for input. 

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Senator Fischer: 

61. Mr. Wehrum, during questioning you stated that you did not have an in depth 

understanding around the Renewable Fuels Standard (RFS). Were you ever counsel for 

any clients involved in lawsuits around the RFS or ethanol-blended fuels? Can you state 

what your role was in that case(s) and who you represented? 

I have worked with the RFS in private practice and in my prior tenure at EPA. I was 

particularly familiar with the first phase RFS rules that implemented the original 

RFS that was enacted as part of the 2005 energy bill. The first phase rules were put in 

place while I was at EPA. OAR was primarily responsible for developing them. I am 

much less familiar with the second phase RFS program, which implemented the RFS 

amendments enacted as part of the 2007 energy bill. The cases I handled after leaving 

EPA dealt with very limited aspects of the RFS including challenges to EPA's EI5 

waiver, EPA's misfueling mitigation rule, and Minnesota's BlO mandate. These cases 

have all been decided and had essentially nothing to do with the second phase 

program nor do they have any direct bearing on RFS implementation going forward. 

Also, there are a number of recent court decisions more pertinent to EPA's most 

recent RFS-related actions that I am not familiar including recent case law on EPA's 

RFS waiver authority that I have not analyzed. I also do not know EPA's view of the 

recent cases and, more broadly, its current view of its waiver authority. 

62. As a follow-up, were you serving in the position you are currently nominated to serve in 

again during the George W. Bush Administration while the RFS 1 was implemented? 

As explained in my response to your first question, the RFSl rules were developed 

and implemented during my prior tenure at EPA. I was involved in that effort. 

63. Do you plan to recuse yourself from any items on the RFS or ethanol-blended fuels that 

you litigated on while in private practice? 

I was counsel of record in cases challenging EPA's E15 waiver, EPA's misfueling 

mitigation rule, and Minnesota's BlO mandate. These cases have all been decided and 

have no direct bearing on RFS implementation going forward. If confirmed, I do not 

believe it will be necessary or appropriate for me to recuse myself from RFS matters, 

although I will continue to work with EPA ethics officials to make sure that I fully 

comply with my obligations, and my intention is to faithfully implement all aspects of 

the CAA, including the RFS. 

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Senator Markey: 

Mr. Wehrum, because of the Landmark 2007 Supreme Court ruling in Massachusetts v. EPA the 

EPA made a finding that carbon pollution poses a danger to America, known as the 

endangerment finding. This ruling made it possible for states like California and Massachusetts 

to use their Clean Air Act Authority to set higher fuel economy emissions standards for vehicles. 

State action combined with my 2007 tuel economy law, resulted in an auto industry approved 

increase of the fuel economy emissions standards to 54.5 miles per gallon by 2025. Those 

standards will save nearly 2.5 million barrels of oil a day by 2030, are the single largest step any 

nation has taken to reduce global warming pollution and will save consumers more than $1 

trillion. And the auto industry has added 700,000 new jobs since these standards began to take 

effect. 

Administrator Pruitt in his confirmation hearing before this Committee stated that the 

Endangerment Finding "needs to be enforced and respected." Administrator Pruitt also said 

earlier this year that "the Clean Air Act focused on mobile sources over the last several years I 

think has made a substantial difference with respect to GHG and C02." 

64. Mr. Wehrum, yes or no, do you agree with Administrator Pruitt that the endangerment 

finding needs to be enforced and respected? 

I have not discussed the endangerment finding with Administrator Pruitt, so I do not 

know his current views on the topic. 

65. Mr. Wehrum, yes or no, do you suppoti EPA's continued regulation of greenhouse gases 

from cars under the Clean Air Act? 

I believe that primary responsibility for regulating fuel economy belongs to the 

Department of Transportation. I believe that it is important for EPA to harmonize its 

actions with those of DOT. 

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Senator Merkley: 

66. If you are confirmed as the Assistant Administrator of EPA's Office of Air and Radiation. 

you will be responsible for implementing the Clean Air Act, which, according to the 

Supreme Court in Massachusetts vs EPA, EPA has the authority to regulate greenhouse 

gases. Therefore, your understanding of the most basic principles of climate change 

science will be essential to your role in the regulation of greenhouse gases. In the 

Intergovernmental Panel on Climate Change's 51

h Assessment Report, entitled, "Climate 

Change 2014 Synthesis Report Summary for Policymakers" (found here: 

~~.~~~,·~~~~~~'""~~~'~'~l~2~~~~~~~,c~~~~~~-LL~·~~~.C~~Jthe 

finding under "SPM I" that is labeled''{ I}" (note that the labels {x} immediately follow 

the findings they refer to), states "Human influence on the climate system is clear, and 

recent anthropogenic emissions of greenhouse gases are the highest in history. Recent 

climate changes have had widespread impacts on human and natural systems. {I}". Do 

you agree with that finding? 

a. If you do not agree with this finding, please explain why, and provide at least one 

peer reviewed study supporting your stated position. 

I believe that the climate is changing and that manmade emissions are 

contributing to the change. I believe that amount attributable to manmade 

emission is not currently known with certainty. The IPCC quote is not 

inconsistent with these views. 

67. In that same report, the finding under "SPM I.!" labeled "{1.1} states "Wanning of the 

climate system is unequivocal, and since the 1950s, many of the observed changes are 

unprecedented over decades to millennia. The atmosphere and ocean have warmed, the 

amounts of snow and ice have diminished, and sea level has risen. { 1.1} ." Do you agree 

with that finding? 

a. If you do not agree, please explain why, and provide at least one peer reviewed 

study supporting your stated position. 

I believe that the climate is changing, as is suggested by the quote. 

68. In that same report, the finding under "SPM !.2" labeled"{ 1.2, 1.3.1}" states 

"Anthropogenic greenhouse gas emissions have increased since the pre-industrial era, 

driven largely by economic and population growth, and are now higher than ever. This has 

led to atmospheric concentrations of carbon dioxide, methane and nitrous oxide that are 

unprecedented in at least the last 800,000 years. Their effects, together with those of other 

anthropogenic drivers, have been detected throughout the climate system and are extremely 

likely to have been the dominant cause of the observed warming since the mid-20'h 

century." Do you agree with this finding"' 

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a. If you do not agree with this finding, please explain why, and provide at 

least one peer reviewed study supporting your stated position. 

I believe that the climate is changing and that manmade emissions are 

contributing to the change. I do not know what is meant by "other 

anthropogenic drivers." If confirmed and as necessary, I can delve 

into this question. 

69. In that same report, the finding under "SPM 2" labeled "{2}" states "Continued emission 

of greenhouse gases will cause further warming and long-tasting changes in all components 

of the climate system, increasing the likelihood of severe, pervasive and irreversible 

impacts for people and ecosystems. Limiting climate change would require substantial and 

sustained reductions in greenhouse gas emissions which, together with adaptation, can limit 

climate change risks. {2} ". Do you agree with this finding? 

a. If you do not agree with this finding, please explain why, and provide at least one 

peer reviewed study supporting your stated position. 

It is my understanding that domestic reductions in greenhouse gas emissions, 

such as those accomplished by EPA's current regulatory programs, are 

projected to have little effect on predicted climate change. 

70. In that same report, the finding under "SPM 3" labeled "{3.2, 3.3, 3.4}" states "Adaptation 

and mitigation are complementary strategies for reducing and managing the risks of climate 

change. Substantial emissions reductions over the next few decades can reduce climate 

risks in the 21st century and beyond, increase prospects for effective adaptation, reduce the 

costs and challenges of mitigation in the longer term and contribute to climate-resilient 

pathways for sustainable development. {3.2, 3.3 .. 3.4} ". Do you agree with this finding? 

a. If you do not agree with this finding, please explain why, and provide at least 

one peer reviewed study supporting your stated position. 

It is my understanding that domestic reductions in greenhouse gas 

emissions, such as those accomplished by EPA's current regulatory 

programs, are projected to have little effect on predicted climate change. 

71. ln that same report, the finding under "SPM 3.2" labeled "{3.2, 3.4} states "Without 

additional mitigation efforts beyond those in place today, and even with adaptation, 

warming by the end of the 21st century will lead to high to very high risk of severe, 

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widespread and irreversible impacts globally (high confidence). Mitigation involves some 

level of co-benefits and of risks due to adverse side effects, but these risks do not involve 

the same possibility of severe, widespread and irreversible impacts as risks from climate 

change, increasing the benefits fi·om near-term mitigation efforts. {3.2, 3.4}". Do you 

agree with this finding? 

a. If you do not agree with this finding, please provide at least one peer reviewed 

study supporting your stated position. 

The Trump Administration has annonnced its intent to reconsider the socalled "social cost of carbon," which is an estimate of the benefit 

associated with each ton of GHG emissions reduced. That work is 

directly related to the topic of this question. If confirmed, I likely will be 

involved in this effort. It is inappropriate for me to prejudge the outcome 

of this effort. 

72. In that same report, the finding under "SPM 4" labeled "{4} states "Many adaptation and 

mitigation options can help address climate change, but no single option is sufficient by 

itself. Effective implementation depends on policies and cooperation at all scales and can 

be enhanced through integrated responses that link adaptation and mitigation with other 

societal objectives. {4}". Do you agree with this finding? 

a. If you do not agree with this finding, please explain why, and provide at least 

one peer reviewed study supporting your stated position. 

To the degree manmade GHG emissions are contributing to climate 

change, I believe that emissions worldwide are contributing. 

73. What are the annual emissions of greenhouse gases from power plants in the United States? 

a. Are power plants one of the largest sources of greenhouse gas emissions? 

I do not know the current level of GHG emissions from domestic power 

plants. Yes, they collectively are one of the largest domestic sources of 

manmade GHG emissions. 

74. Mr. Wehrum, in your testimony, you said that human's contribution to climate change is 

"an open question". Please name which of these major scientific organizations have stated 

that human activity is the major driver of climate change. 

The American Association for the Advancement of Science (AAAS) 

American Chemical Society 

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American Geophysical Union; 

American Institute of Biological Sciences; 

American Meteorological Society; 

American Public Health Association; 

American Society of Agronomy; 

American Society oflchthyologists and Herpetologists; 

American Society ofNaturalists; 

American Society of Plant Biologists; 

American Statistical Association; 

Association for the Sciences of Limnology and Oceanography; 

Association for Tropical Biology and Conservation; 

Association of Ecosystem Research Centers; 

BioQUEST Curriculum Consortium; 

Botanical Society of America; 

Consortium for Ocean Leadership; 

Crop Science Society of America; 

Ecological Society of America; 

Entomological Society of America; 

Geological Society of America; 

National Association of Marine Laboratories; 

Natural Science Collections Alliance; 

Organization of Biological Field Stations; 

Society for Industrial and Applied Mathematics; 

Society for Mathematical Biology; 

Society for the Study of Amphibians and Reptiles; 

Society ofNematologists; 

Society of Systematic Biologists; 

Soil Science Society of America; 

University Corporation for Atmospheric Research. 

My statement was not based on the views of these groups. 

75. Mr. Wehrum, in your testimony, you declined to comment on the graphs I presented 

depicting the natural forces on observed temperature, and of greenhouse gases on observed 

temperature, saying you would need to see the underlying data. This website provides a 

clear presentation of the data, h\tJ1~L\ny\~_,hl_l~lm.hgg&QII!L!!JIIQl}h:,>L~.QJ2~~1llit~.:.l:'m:millg: 

111~-woridi, as well as an explanation of the methodology for these charts, including links to 

the models and data. Now that you have the time to review the methodology and data, can 

you please provide your own interpretation ofthese data sets? 

a. Do you agree with NASA's linding that human activity is the primary driver of 

climate change as shown by these data sets? 

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b. If you do not agree with NASA's finding from these data sets that human 

activity is the primary driver of climate change, please explain, in detail, your 

critiques of these data sets, and please cite at least one peer reviewed study 

that informs your critique. 

Given the short schedule provided for responding to these questions, and 

given the substantial number of complex questions, I have not had time to 

further investigate your graphs or the data used to prepare the graphs. 

76. You responded to my question about ocean acidification with the response that you are 

familiar with the "allegation of ocean acidification." The definition of allegation, 

according to Merriam-Webster. is "l. The act of alleging something". where "alleging" 

means "to assert without proof or before proving", and "2. A positive assertion especially 

of misconduct", and "3. An assertion unsupported and by implication regarded as 

unsupportable". Given that NOAA has directly measured changes in the pH of the oceans, 

showing that ocean water has become more acidic over time, do you believe that "ocean 

acidification" is an assertion "without proof'? 

a. If you believe ocean acidification is an allegation, do you doubt scientists' 

ability to measure the pH of water? 

b. If you do not believe that "ocean acidification" is an assertion "without 

proof', then will you retract your use of the word "allegation" to describe 

ocean acidification? 

c. Scientists from both NOAA and the EPA have published information and data 

QC:.hlif!catioQ and here: Can 

you please describe both NOAA and EPA's conclusion on the causes of ocean 

acidification? 

d. In your testimony, you said you would defer to EPA scientists and career staff 

on matters of science. Will you defer to EPA career staff on the science of 

climate change and ocean acidification? 

e. Please describe your current understanding of ocean acidification in detail, 

and provide at least one peer reviewed study supporting your stated position. 

Given the short schedule provided for responding to these questions, and 

given the substantial number of complex questions, I have not had time to 

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review the sources to which you refer in this question. I have high regard 

for EPA career staff and executives. If confirmed, I will consider their 

views and advice very carefully on all matters, including climate change 

and ocean acidification. 

77. In a recent public disclosure of Administrator Pruitt's calendar of meetings, less than 3% 

of his meetings were with public health and environmental advocacy organizations, 

whereas over 25% of his meetings were with industry representatives. Do you believe this 

reflects fair and balanced input from public health and environmental advocacy 

organizations? 

I am not familiar with Administrator Pruitt's schedule, so I cannot comment on it. 

78. Will you commit to a fair and balanced ratio of input from public health and 

environmental advocacy organizations? 

Many parties that are not subject to EPA's rules are affected by the rules and should 

have the opportunity for input. I fully intend to have an open door policy on all 

issues. 

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Senator Sanders: 

Climate Change 

79. President Trump has suggested in the past that climate change is a hoax. Is the President 

correct? Is climate change a hoax? 

I believe that climate change is real and human activity contributes to climate change. 

80. Do you agree with the vast majority of scientists that climate change is real, is caused by 

human activity, and that we must aggressively transition away from fossil fuels and toward 

energy efficiency and sustainable energy like wind, solar, and geothermal? 

I believe that climate change is real and human activity contributes to climate change. 

81. Do you agree with the vast majority of scientists that the combustion of fossil fuels 

contributes to climate change? 

Yes, the combustion of fossil fuels results in GHG emissions, which contribute to 

climate change. 

82. If confirmed, what will you do to ensure that OAR addresses climate change? 

If confirmed, I will faithfully implement the Clean Air Act, including authorities 

related to GHGs and climate change. 

Background 

83. As a lobbyist with Hunton and Williams, you have represented a host of fossil fuel and 

chemical companies in lawsuits, some of which are still active, against the EPA. If 

confirmed, you would be in charge of making sure that these industries install necessary 

pollution control technologies and conduct waste cleanup. 

As Assistant Administrator for the Office of Air and Radiation, would you have any 

active conllicts of interests with these companies? If so, will you commit to recuse 

yourself for the full course of any matter in which any of your former clients is a party? If 

not, why not? 

Comprehensive rules of ethics govern the transition from private practice to 

government service. If confirmed, I will work closely with EPA ethics officials to 

understand and strictly comply with my ethical obligations. 

84. While serving as Assistant Administrator for the Office of Air and Radiation under 

President Bush, you attempted to roll back environmental protections under the Clean Air 

Act. These rollback attempts were eventually defeated in the Supreme Court. If confirmed. 

will you commit to carrying out the Oftice of Air and Radiation's obligations under the 

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law, including as decided by the Supreme Court? 

If confirmed, I will faithfully implement the Clean Air Act, including as construed by 

the US Supreme Court. 

85. In your past career, you have brought suit against the EPA for its enforcement of the Clean 

Air Act. Can you explain why federal courts should be in the position of determining safe 

levels of pollution to protect the health and welfare of Vermonters, as opposed to the 

federal Agency whose mission it is to protect human and environmental health? 

Separation of powers is a core principle embedded in the US Constitution. As applied 

here, US EPA has been authorized by Congress to implement the national 

environmental laws. The role of the courts is to determine if EPA has fulfilled its legal 

obligations. 

86. At the EPA, science provides the foundation for Agency policies, actions, and decisions 

made on behalf of the American people. What should the role of science be in the 

development of EPA policies, rules, and regulations? 

As you say, science provides the foundation for many agency policies, actions, and 

decisions. EPA's role is to apply science and other relevant information in 

implementing the law. 

Most Pressing Challenges 

87. In your opinion, what are the most pressing air quality challenges that deserve the attention 

of the EPA? What will you do at the EPA to better address these challenges? 

Full implementation of the CAA § 112 air toxics program is one of the most pressing 

and difficult challenges facing OAR. If confirmed, this would be a priority for me and 

my staff. 

Environmental Regulations 

88. If confirmed, do you commit to upholding the goal of the Clean Air Act, which according 

to the EPA website is "to address the public health and welfare risks posed by certain 

widespread air pollutants''? 

Yes. 

89. The EPA has adopted many cost-effective safeguards in the past eight years that would 

significantly reduce the pollution that contributes to asthma in children. If confirmed, will 

you commit to addressing threats from air pollution to America's children? 

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Yes, protecting the public health requires consideration of susceptible subpopulations, 

such as children. 

Environmental Justice 

90. If confirmed, will you commit to addressing the growing environmental and economic 

justice issues associated with air quality? 

If confirmed, I commit to working with you to promote public health and equal 

application of the law for all Americans. 

91. If confirmed, will you commit to addressing issues of environmental justice in Native 

American communities and offer a voice to those most affected by the environmental 

consequences of industrialization, especially in regard to resources protected by treaties? 

If confirmed, I commit to working with you to promote public health and equal 

application of the law for all Americans, including Native Americans. 

92. Latino children are twice as likely as non-Latino white children to die from asthma while, 

from 2012-2014, African American children had a death rate ten times that of non-Latino 

white children. African American children are three times as likely to suffer an asthma 

attack. 

As Assistant Secretary of Air, will you commit to ensuring that vulnerable low-income 

communities and communities of color are protected from the harmful impacts of air 

pollution? 

If confirmed, I commit to working with you to promote public health and equal 

application of the law for all Americans, including low-income communities and 

communities of color. 

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Senator Whitehouse: 

93. You have been leading the fight against EPA air standards so it's unclear to me how you're 

capable of serving in this position consistent with the requirements of Executive Order 

13770, "Ethics Commitments by Executive Branch Employees," otherwise known as the 

Trump ethics pledge. The pledge prohibits appointees from "participat[ing] in any 

particular matter involving specific parties that is directly and substantially related to [their] 

former employer or former clients'' for the first two years after their appointment. Your 

ethics agreement states you intend to sign the pledge. We are aware of dozens of separate 

air cases you've worked on for clients regulated by EPA during your time at Hunton & 

Williams. Fut1her, your law firm has performed millions of dollars worth of lobbying for 

Exxon Mobil, Koch Companies, Southern Company, and several other companies 

regulated by EPA. 

a) To ensure compliance with the pledge, please provide for the record all of Hunton & 

Williams clients, c.ases, regulatory matiers, and issues/legislation on which its lobbied 

from the past two years, noting aU clients with whom you've worked, cases on which 

you've worked, regulatory work you've done, and any issues/legislation on which 

you've lobbied. 

b) Your financial disclosure or 278 form does not require disclosure of pro bono work. 

For the past two years, please provide a list of all Hunton & Williams pro bono work, 

including the clients, cases, regulatory matters, and lobbying, noting all pro bono 

clients with whom you've worked, pro bono cases on which you've worked, pro bono 

regulatory work you've done, and pro bono lobbying you've preformed. 

I do not have a list of all particular matters involving specific parties in which 

Hunton & Williams is a party or represents a party. If confirmed, I intend to 

ascertain Hunton's involvement on a case-by-case basis before becoming 

involved in any particular matter involving specific parties. With regard to pro 

bono, for the past two years I have done work on state "freedom of information 

act" laws for a non-profit charitable organization. Please see attachment L 

94. Your ethics statement suggests to me that you will be seeking waivers to ethics 

requirements. You may be allowed to seek a waiver, which I find troubling given your 

extensive history attacking clean air regulations on behalf of companies regulated by EPA. 

a. Please identify all particular matiers which you believe at this time may require 

you to seek a waiver. 

b. For each of these matters, please state why it would be in the public interest to 

grant you a waiver. 

c. For any matters that you have not identified in response to this question, will you 

commit to not seeking a waiver from ethics requirements? 

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I do not have current plans to seek waivers. 

95. Through documents produced from Oklahoma Open Records Act requests, we also know 

that Hunton & Williams staff worked with industry in key states to get other state 

Attorneys General on a comment letter Pruitt was leading to EPA opposing the carbon 

pollution standards for new power plants. Hunton & Williams staff also worked with 

Pruitt's staff to discuss who to approach about signing on, and coached them on how and 

when to submit the comments. Which client or clients did Hunton and Williams bill for this 

work? 

The client(s) has not authorized me to disclose this information. 

96. According to a separate set of documents, some of which are marked "confidential", 

Hunton & Williams arranged a Summit on Federalism and the Future of Fossil Fuels 

convened by then-Oklahoma Attorney Genera! Pruitt, sponsored by the George Mason 

School of Law's Law & Economies Center. Which client or clients did Hunton and 

Williams bill for this work? 

The client(s) has not authorized me to disclose this information. 

97. Hunton & Williams, directly contributed to Scott Pruitt's campaign in 2010 and contributed 

over $200.000 to RAGA and RAGA's predecessor organization, the Republican State 

Leadership Committee during Scott Pruitt's time as board chair and on the executive 

committee. 

a. Between November I, 2011 and February 17,2017, how much have you or Hunton & 

Williams contributed to the Rule of Law Defense Fund (RLDF)? 

b. While Scott Pruitt was Attorney General of Oklahoma. what. if any, fundraising 

events for Scott Pruitt did you attend? 

c. While Attorney General of Oklahoma, did Scott Pruitt ever solicit money from you or 

Hunton & Williams for his campaign, his Oklahoma Strong or Liberty 2.0 PACs, 

RAGA, or the RLDF? 

d. If yes, please describe each solicitation and how much you and Hunton & Williams 

contributed as a result of each solicitation. 

e. Please provide a list of all RAGA or RLDF contributions, calls, meetings, events, or 

activities of yours or Hunton & Williams since November I, 2011 and February 17, 

2017. 

I have not contributed to or been involved with RLDF, Administt·ator Pruitt's 

campaigns or PACs, or to RAGA. Hunton & Williams' political contributions 

are a matter of public record. 

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98. Please describe any role you or Hunton & Williams played in the establishment of or 

financial contributions to America Rising, America Rising Squared, Protecting America 

Now, and any other organizations that funded efforts to get Scott Pruitt confirmed as EPA 

Administrator. 

I played no role in any of these efforts or organizations. I am not aware that anyone 

from Hunton was involved. 

99. EPA Administrator Pruitt recently told CNBC that "I would not agree that [carbon 

dioxide's] a primary contributor to the global warming that we see." Based on the 

scientific findings from experts such as NOAA and statements on EPA's website, including 

"Carbon dioxide is the primary greenhouse gas that is contributing to recent climate 

change," Po!itifact determined that statement to be false. Do you agree with Administrator 

Pruitt or scientific experts regarding whether carbon dioxide is the primary greenhouse gas 

that is contributing to climate change? 

I believe the degree to which manmade GHG emissions are contributing to climate 

change has not been conclusively determined. 

toO. In 2009, as mandated by the Supreme Court and backed by a robust scientific and 

technical review, the Environmental Protection Agency produced the Endangerment and 

Cause or Contribute Findings for Greenhouse Gases (GHGs) under Section 202(a) of the 

Clean Air Act. It found six greenhouse gases • carbon dioxide, methane, nitrous oxide, 

hydrofluorocarbons, perfluorocarbons, and sulfur hexafluoride- "taken in combination 

endanger both the public health and the public welfare of current and future generations." 

a. Do you agree with the EPA's endangerment finding? Why or why not? 

b. Do you commit to not take any steps to narrow the scope or otherwise weaken 

the endangerment finding? 

I have not read the endangerment finding or the record prepared in 

support of the finding. Therefore, I currently do not have a view. 

Otherwise, I cannot prejudge any decision that might be made by EPA if 

I am confirmed. 

10 l. Four Republican former EPA Administrators- Bill Reilly, Bill Ruckelshaus, Lee 

Thomas, Governor Christine Todd Whitman testified before EPW that climate change is 

real and EPA has clear authority under the Clean Air Act to curb carbon dioxide? 

a. Do you agree that climate change is real? 

b. Do you agree that EPA has authority under the Clean Air Act to reduce carbon 

dioxide? 

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I agree that climate change is real and that EPA has limited authority 

under the CAA to regulate carbon dioxide emissions. 

I 02. Industry frequently talks about compliance costs while ignoring the costs to people 

harmed by the effects of pollution. In Rhode Island these effects cannot be ignored as we 

see them through bad air days and other problems. Because Rhode Island ozone air quality 

issues are largely due to transported emissions from upwind states leading to ozone 

formation that pollutes the air and lungs of people in downwind states like mine. Over the 

past two years in Rhode Island, the 8-hour standard ozone standard exceeded 0.07 ppm I 0 

times in 2015 and 6 times in 2016. 

a. With respect to ozone, do you believe EPA should look at only the costs to 

industry when undertaking its regulatory impact analysis? 

b. Should the costs to families, such as children sent to emergency rooms due to 

asthma attacks triggered by smog, be included in the analysis? 

c. If so, should those costs be given a different weight than those claimed by 

industry? 

Costs can be considered in setting some, but not all, Clean Air Act rules. 

But, even when costs cannot be considered, it is important to prepare a 

comprehensive regulatory impact analysis so that the full costs and 

benefits of a rule are known. If confirmed, I will work hard to ensure 

that costs and benefits are accurately assessed and appropriately 

considered. 

103. Ozone levels in Rl are strongly affected by the transport of pollutants emitted in upwind 

states into Rl. Although Rl is currently designated as an unclassifiable/attainment area for 

the ozone NAAQS, monitored ozone levels in the state still exceed the standard on a 

nmnber of days in the summer months because of out of state pollution. 

a. What, if any steps, have you taken in your career to help reduce the transport 

of pollution from upwind states into downwind states like Rhode Island? 

b. If confirmed, what steps will you take to address the transport of pollutants 

emitted in upwind states that contribute to exceedanccs of the ozone standard 

in Rl and other downwind states? 

The "Clean Air Interstate Rule" was issued during my prior tenure at 

EPA. It was designed to address "interstate transport" (including into 

the State of Rhode Island) under the authority of CAA § 110(a)(2)(D). If 

confirmed, I intend to faithfully implement the Clean Air Act, including 

the interstate transport provisions. 

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l 04. According to EPA, 49% of coal units lack the most advanced NOx controls (Selective 

Catalytic Reduction systems or SCR). Several units that have SCR or other NOx emission 

control technology installed are not optimizing their use. For example, these six coal units 

have SCR installed but are not using it to optimize NOx reductions. In 20 I 5, these 

facilities' NOx emissions were significantly higher than 2009 because they are not using 

the systems they have in place to reduce NOx. 

Facilities wi1h Increasing ::\0;;; 

FacilitY )!Ox Emission Increase )!Ox Rate ltJcrense ~~~;;p;;\,~ statk;~\'VeS't\Tk'g1n~-.,~--·~,..__,,,_'"'~''1};Y3910llS"(277~~) ____ ,__.,...,..02-::'"'fu:··mnlBtu (:UO%J -·,--~ 

Ke\'Stone, Pennsvh·ania 101 59-:t tons (,28:5?~) 0.2..:; lb nm1Btu (296~·0 I 

PleasantsPm,.·erstatio~ \\~st Yirginia S,734tons(34l?f0) 0.14 rb/mmBtu(.Z84%) 

HonEr CitY. Pennsvlvania 7~52.:: tons('72il/Q) 0.20 IlnnmBt\1(107°·0) 

Montour. Pt;nnsyl\•ania 5,889 tons(109%\ o.::.t lhmmBtu (1.07%) 

St JohnsRiwrPo:·:~r. Fkll'ida 4,~6.2 tor_s(600:·o:t 0.:!31bmm.Btu(142%) 

a. Why would this be the case? 

b. Do you think these facilities should be required to keep on their NOx controls on? 

I am not familiar with these particular power plants and do not know why 

they emit at the levels you report. 

105. EPA's independent science advisers, leading medical groups like the American Medical 

Association, American Academy of Pediatrics, American Thoracic Society, American 

Lung Association, American Heart Association, and leading public-interest groups such as 

the NAACP called for a 60 ppb standard instead of the 70 ppb standard EPA finalized last 

year. 

a. What do you believe is a health-protective standard for ozone? 

b. Do you agree that one of the goals of the Clean Air Act is to set NAAQS 

standards to address the public health and welfare risks ofNAAQS pollutants? 

c. When considering setting NAAQS limits, should cost be considered? 

I am not familiar with the current science on the health effects of ozone, so I 

cannot comment on your question as to the appropriate level of the standard. 

The US Supreme Court has ruled that cost may not be considered in 

determining the level of a NAAQS and that a primary standard should be set 

at the level "requisite" to protect public health with an adequate margin of 

safety. I respect the court's decision. 

106. According to the EPA, it has been estimated that the Clean Air Act has a history of 

reducing air pollution, while creating jobs, Since 1970 aggregate emissions of common air 

pollutants dropped 72 percent, while the U.S. gross domestic product grew 219 percent. 

Total private sector jobs increased by l 01 percent over the same period. In 2020, EPA 

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estimates that the standards will create the equivalent of over 104,000 new jobs including 

17,000 new jobs building renewable energy facilities and over 78,000 jobs in improving 

demand-side energy efficiency. 

a. Do you agree that regulations under the Clean Air Act since 1970 have helped 

grow the economy? 

b. If not, can you provide your analysis, materials used, and people you solicited to 

come to this conclusion? 

I am not familiar with the EPA analysis that produced these estimates. I 

believe that some, but not all, CAA-based regulations produce net benefits to 

the country. 

107. How will you separate your history representing polluters in challenging environmental 

protections to defending EPA's mission of protecting public health and the environment? 

Comprehensive rules of ethics govern the transition from private practice to 

government service. If confirmed, I will work closely with EPA ethics officials to 

understand and strictly comply with my ethical obligations. 

108. Have you heard anything to suggest that EPA may close or consolidate any Regional 

Offices? What is your opinion of such a proposal? 

I do not know whether this is being considered and do not have an opinion. 

109. During previous administrations, senior EPA managers' schedules have been available to 

the public and Administrator Pruitt recently started releasing his. If confirmed, do you 

agree to make your schedule available as well? 

If confirmed, I will make my calendar available on a timely basis. 

II 0. I found it extremely troubling that when asked about ocean acidification during your 

confirmation hearing. that you, a chemical engineer, said you were "aware of the 

allegation." The definition of"altegation" is "a claim or assertion ... typically one made 

without proof." According to the following experts, ocean acidification is real and 

occurring: 

National Academics of Sciences, Engineering and Ms;dicine 2013 Review of the Federal 

Ocean Acidification Research and Monitoring Plan: 

"The world's ocean has already experienced a 30% rise in acidity since the industrial 

revolution, with acidity expected to rise 100 to 150% over preindustrial levels by the end 

of this century. Potential consequences to marine life and also to economic activities that 

depend on a healthy marine ecosystem are diftlcult to assess and predict, but potentially 

devastating. •· 

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EPA 2016 Report on Climate Change Indicators in the U.S.: 

"As the concentration of carbon dioxide in the atmosphere increases, the ocean absorbs 

more ofit. Over the past 250 years, oceans have absorbed about 28% of the carbon dioxide 

produced by human activities that burn f()ssil fuels. Rising levels of carbon dioxide 

dissolved in the ocean negatively aftect some marine life, because carbon dioxide reacts 

with sea water to produce carbonic acid. The increase in acidity changes the balance of 

minerals in the water and makes it more difficult for corals and plankton to produce the 

mineral calcium carbonate, which is the primary component of their hard skeletons and 

shells. Resulting declines in coral and plankton populations can change marine ecosystems 

and ultimately affect fish populations and the people who depend on them. Signs of damage 

are already starting to appear in certain areas. 

Measurements made over the last few decades have demonstrated that ocean carbon 

dioxide levels have risen in response to increased carbon dioxide in the atmosphere, leading 

to an increase in acidity." 

NOAA Ocean Acidification Program: 

''Ocean acidification is occurring because our ocean is absorbing carbon dioxide from the 

atmosphere, leading to lower pH and greater acidity. This is causing a fundamental 

change in the chemistry of the ocean. 

Since the industrial revolution, the atmospheric concentration of carbon dioxide has 

increased from 280 to over 400 parts per million due to the burning of fossil fuels such as 

coal, gas, and oil, along with land use change. Ocean acidification refers to a change in 

ocean chemistry in response to the uptake of increasing carbon dioxide (C02) in the 

atmosphere. The world's surface ocean is tightly linked with the atmosphere and absorbs 

huge amounts of carbon dioxide each year. This exchange, in part, helps to regulate the 

planet's atmospheric C02 concentrations, but comes at a cost for the oceans and life 

within it; tl·om the smallest, single celled algae to the largest whales. Were it not for 

ocean uptake of C02, atmospheric C02 levels would be increasing at an even greater rate 

than they are now." 

NOAA Pacific Marine Environmental Labogton_Carbon Program: 

"Since the beginning of the Industrial Revolution, the pH of surface ocean waters has f.1llen 

by 0.1 pH units. Since the pH scale, like the Richter scale, is logarithmic, this change 

represents approximately a 30% increase in acidity. Future predictions indicate that the 

oceans will continue to absorb carbon dioxide and become even more acidic. Estimates of 

future carbon dioxide levels, based on business as usual (BAU) emission scenarios, 

indicate that by the end of this century the surface waters of the ocean could be nearly 

!50% more acidic, resulting in a pH that the oceans haven't experienced for more than 20 

million years." 

Do you accept the findings of these experts that: 

a. The human-caused increase in atmospheric carbon pollution is directly 

related to decreases in ocean pH (ocean acidification)? 

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b. Oceans are currently acidifying at a rate unprecedented in tens of millions 

of years? 

c. Ocean acidification is damaging coral reefs worldwide, important habitats 

for recreation, tourism, and commercial fishing? 

d. Ocean acidification is harmful to marine ecosystems, negatively affecting 

tish populations and the communities who depend on them? 

e. If you do not agree with any of these statements, please identify the 

evidence, studies, or analyses you are relying upon to justify your position. 

Given the short schedule provided for responding to these questions, 

and given the substantial number of complex questions, 1 have not had 

time to review the sources to which you refer in this question. 

111. Since 2009, the states participating in the Regional Greenhouse Gas Initiative (RGGl) 

have seen carbon pollution fall by 18% while their economies grew by 9.2%. Emissions in 

the other 41 states fell by 4% while their economies grew by 8.8%. 

a. Do you agree that RGGI has developed a successful model for growing our states' 

economics and cutting carbon pollution at the same time? 

b. Do you believe funding levels for EPA grant programs that fund state level 

initiatives to reduce their emissions should remain level, be increased, or be 

decrea~ed? 

The very low allowance prices under RGGI and tile similar performance in 

other states suggest that RGGI is not a driving factor in these statistics. If 

confirmed, I will manage OAR's programs within tile authorities and budget 

provided by Congress, including STAG grants. 

112. EPA operates multiple networks to monitor compliance with the Clean Air Act's 

National Ambient Air Quality Standards and to track hazardous air pollutants regulated 

under the act. These networks include, among others, the State and Local Air Quality 

Monitoring Network, the National Air Monitoring Network (which targets areas of high 

population density with a variety of air pollution sources), Special Purpose Monitoring 

Stations (used for short-term studies and other purposes), Photochemical Assessment 

Monitoring Stations (used to measure pollutant.~ that contribute to ground-level ozone, a 

harmful air pollutant), and the National Air Taxies Trends Stations. 

a. What is your vision for air monitoring? 

b. Do you believe funding at EPA for these important monitoring networks should 

remain level, be increased, or decreased? 

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c. Under your leadership, will you push for greater inclusion of technology-based 

tools for compliance monitoring and implementation, including electronic 

reporting and additional air monitors? 

Actual air monitoring data is far preferable to modeling or other forms of 

estimation. The question of compliance monitoring is primarily the 

responsibility of the Office of Enforcement and Compliance Assurance, with 

which I will work closely, if confirmed. With regard to budget, if confirmed, 

I will manage OAR's programs within the authorities and budget provided 

by Congress. 

113. Section 105 grants provide significant funding to states for implementing the Clean Air 

Act requirements. EPA is proposing a new formula for how the 105 grants are distributed 

to each of the regional offices (and subsequently to the states). Region I, where Rhode 

Island receives its funding from, wiH receive a smaller percentage of the total 105 funds 

under this revised formula. EPA is proposing an implementation approach that would limit 

regional losses to no more than 2.5% from each region's prior year amount. Region I will 

lose 2.5% for, at least, each of the next five fiscal years and possibly ten years, under this 

proposed approach. Will you commit to not implementing the new formula until and 

unless there is sufficient overall funding such that no Region will see reduced funding from 

the prior year's amount? 

If confirmed, I will manage OAR's programs within the authorities and budget 

provided by Congress, including STAG grants. 

114. The Clean Air Act regulates air emissions from stationary and mobile sources, protecting 

public health and ensuring Americans have sate air to breathe. Concentrated animal 

feeding operations (CAFOs) may emit air pollutants in high enough quantities to subject 

them to CAA and other statutory requirements. 

a. Do you believe CAFOs pollute the air? 

b. Do you believe it is important for EPA, state and local agencies, and the 

public to know what air quality and health risks are posed by animal 

feeding operations? 

c. Will you commit to ensuring that the law is enforced with regards to 

CAFOs. 

CAFOs emit a number of CAA-regulated air pollutants. CAFOs also 

are different than most other stationary sources regulated under the 

CAA. These differences must be carefully considered in crafting any 

CAA-bascd regulatory requirements. 

115. On September 19,2017, the EPA Office of Inspector General (OIG) released a report on 

EPA's attempts to develop reliable emission estimation methods (EEMs) to determine 

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whether animal feeding operation are subject to or comply with Clean Air Act permit 

requirements or emission reporting requirements under CERCLA or EPCRA (Report No. 

17-P-0396). On June 23, 2017, the Office of Air and Radiation agreed with OIG's 

recommendations and OIG has accepted its planned corrective actions. If confirmed, do 

you commit to ensuring EPA fulfills its commitment to implement the actions laid out in 

OAR's June 23. 2017 letter to OIG? 

I am not familiar with the OIG report or OAR's response. If confirmed, I will take 

time to familiarize myself with these materials and this issue. 

116. O!G's September 19, 2017 report (Report No. 17-P-0396) on animal feeding operations 

cited a lack of EPA agricultural air expertise and committed resources as a factor in delays 

in developing emission estimating methodologies. 

a. Given President Trump's proposed cuts to EPA's budget, how do you envision 

implementing the actions agreed to by OAR in Report No. 17-P-0396? 

b. What is your vision for protecting public health by ensuring animal feeding 

operations are meeting CAA and other statutory requirements? 

I am not familiar with the OIG report, so cannot comment on its findings. In 

my experience, OAR career staff and executives have ample experience and 

expertise with agricultural issues, including those arising at CAFOs. 

ll7. Until recently, Carl lcahn served as a special advisor to the President on overhauling 

regulations. Carllcahn is also a majority owner ofCVR Energy which is an oil refiner that 

has a compliance obligation under the RFS to blend its oils with renewable fuels. !calm's 

company has repeatedly benefited when he has proposed changes to the RFS that would 

benefit CVR and through speculation in the Renewable Identification Numbers (R!Ns) 

market. For example, in February of2017 Mr. lcahn reportedly presented the White House 

with draft Executive Order language that would reform the RFS to benefit CVR 

energy. The same day, CVR's stock value increased by 3.5%, representing a multi-million 

dollar windfall to lcahn. 

a. Please describe any interactions you've had with Carl kahn, CVR Energy, 

Valero, or other entities about the RFS in the past two years. 

b. Do you think it is appropriate for an Administration official like Mr. lcahn to 

propose making changes to EPA regulations that clearly benefit a company he 

owns? 

c. If you are confirmed as AA of OAR, and Car! lcahn or CVR Energy approaches 

you about a matter related to the RFS, do you think would be appropriate to talk 

with him? 

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d. Will you commit to not talking with Carl Jcahn about the RFS? 

I have had no interactions with Carllcahn, CVR Energy, or Valero on the 

RFS in the past two years. I do not recall interactions with other entities on 

the RFS in the past two years, although I occasionally offer implementation 

advice to clients on the RFS. If confirmed, I fully intend to have an open 

door policy on all issues, which might include meetings with both proponents 

and opponents of the RFS. 

I 18. Since July, EPA has submitted two different proposals that would lower the volumes for 

biodiesel and renewable diesel. Congress told EPA to increase the volumes of biodiesel 

and renewable diesel, and both the President and Administrator Pruitt have pledged their 

support for the RFS. How do you explain EPA's actions? 

I am not involved in EPA's decisions about RFS implementation, so I cannot explain 

their current thinking. 

119. In your professional career you have specifically worked against the interests ofbiofuels 

and have represented the petroleum sector in multiple law suits. As Assistant 

Administrator how would the biodiesel and renewable diesel industries get a fair hearing 

1rom you? 

Comprehensive rules of ethics govern the transition from private practice to 

government service. If confirmed, I will work closely with EPA ethics officials to 

understand and strictly comply with my ethical obligations. Further, I commit to 

implementing an open dom· policy in meeting with all relevant stakeholders within 

OAR and will work to faithfully implement all aspects of the CAA, including the RFS 

in an impartial manner. 

120. In July, the DC Circuit Court in ACE vs. EPA said, EPA can't use general waive 

authority to regulate supply under the RFS. Yet in the most recent proposal from EPA, 

EPA is proposing exactly that and is working to use general waive authority to decrease the 

volumes based on supply. Clearly we have billions of gallons ofbiodiesel and renewable 

diesel that qualify for the program and are ready to be produced here in the United States, 

in Canada and throughout the world. Isn't EPA setting itself up for another lawsuit? 

I am not familiar with EPA's recent RFS proposals or on the Agency's view as to how 

they relate to the recent court decision. 

121. The EPA has signaled its planned rejection of the proposal to change the point of 

obligation under the law. The Agency has yet to issue a decision. If confirmed, will you 

finalize and issue the Agency's rejection of this proposal, and if so, when? Have you ever 

expressed a view on proposals to change the point of obligation and if so, what was it? 

I expressed a view on this topic when the RFSI rules were established during my 

prior tenure at EPA. At that time, I supported the point of obligation tbat, then and 

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now, is contained in the rules. I have not expressed a view on the possibility of 

changing the point of obligation. I cannot prejudge any decision that might be made 

by EPA ifl am confirmed. 

122. On September 26, the EPA issued a Notice of Data Availability that proposed to make 

significant, substantial changes to its proposed 2018 RVO and provided for a IS-day 

comment period. NODAs are generally used to provide data and supplement information in 

the record. In this case, the EPA has proposed to make material changes to its original 

proposal, offering stakeholders only IS days to comment on something that, if adopted, 

would negatively impact the U.S. biodiese! industry and set the stage for unjustified 

reductions in perpetuity. In your experience, is this a typical use of a NODA, and can you 

give me another example when the EPA has used a NODA in this manner? Do you believe 

that IS days is an appropriate comment period for a proposed rule under the RFS? In your 

opinion, is inventing a new methodology to justity a pre-determined outcome an 

appropriate process to apply in EPA rulemakings under the RFS? 

I do not know why EPA decided to issue a NODA rather than a supplemental 

proposal. What matters most is whether interested parties have received adequate 

notice of a possible rule change. I believe the NODA provided such notice. The CAA 

does not specify a minimum period for public comments. I know that issuing RVOs 

takes a lot of work and meeting the annual schedule is always a challenge. A short 

comment period on a set of narrow issues may be what is needed to keep this rule on 

schedule. 

123. Do you believe methane is a greenhouse gas? What is methane's global warming 

potential, and from what source does that number come? 

Yes, methane is a GHG. When it established NSPS limits on methane for the oil and 

gas industry, EPA estimated the global warming potential of methane to be 25. See, 

81 Fed. Reg. 35824,35827 (June 3, 2016). 

124. Is it your understanding that EPA will enforce the methane rule on a case-by-case 

basis? Please explain how EPA's case-by-case approach to compliance with the Methane 

Rule is consistent with EPA's "No Action Assurance" policy, which dates back to 1984. 

I do not know what it means to "enforce the methane rule on a case-by-case basis." I 

have no official knowledge of EPA potentially issuing a no-action assurance with 

regard to aspects of the "Quad Oa" methane rule, nor am I aware that any such 

document has been issued. 

125. Which states have been delegated enforcement authority over the Methane Rule? What 

oversight and/or assistance will EPA provide these states to ensure that regulated entities 

are complying with the rule? 

I do not know which states have been delegated enforcement authority for the 

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Methane Rule. When such delegation is made, EPA retains authority to interpret and 

enforce the rule. 

126. What types of reports and notifications should EPA require states with delegated 

enforcement authority to submit to the agency to ensure that the states are enforcing the 

methane rule? 

The rules (such as they are) that govern delegation appear at 40 CFR Part 60 Subpart 

A. 

127. Administrator Pruitt has heen criticized for spending a disproportionate amount of his 

time meeting with industry and virtually no time with public-interest groups. Tf con finned, 

will you commit to meet with and listen to all parties, including environmental and public 

health groups, in a balanced fashion? 

If confirmed, I fully intend to have an open door policy on all issues. 

128. If confirmed, do you commit to notifying the Committee of all of the email addresses you 

plan to usc upon confirmation and within seven days of using a new email address. 

including any aliases or pseudonyms? Do you commit do conducting all business using 

official email addresses and other means and to refrain from any mediums that are outside 

the Freedom oflnformation Act's reach? 

I intend to conduct all official business usinj.! my published EPA e-mail address. I do 

not intend to use my personal e-mail address or any pseudonym. 

129. Do you believe the U.S. should remain a party to the United Nations Framework 

Convention on Climate Change? 

The UNFCC is a treaty. The US Department of State has primary responsibility for 

treaties. I defer to State on this issue. 

130. Do you believe the U.S. should remain a party to the Paris Agreement? 

The Paris Agreement is an international agreement. The US Department of State has 

primary responsibility for such matters. I defer to State on this issue. 

131. If confirmed, do you commit to providing complete and accurate responses to inquiries 

from EPW members in a timely tashion. 

Administrator Pruitt has made responsiveness to Congress an important priority. The 

2800 pages of EPA responses provided to Members of the EHironment and Public 

Works Committee on display at the nomination hearing is a testament to this 

commitment. Accordingly, I will continue to be a part of EPA's transparent and 

responsive culture. 

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132. Do you think there should be a standardized social cost of carbon? Is the social cost of 

carbon greater than zero dollars per metric ton? If so, what is the most accurate social cost 

of carbon in 2017 and what is the best way to calculate this number? 

EPA develops benefits estimates for many CAA-regulated pollutants. The "social cost 

of carbon" is a benefits estimate and it would be consistent with EPA practice to 

develop such a value. I do not know enough about the underlying data to suggest an 

appropriate value. It is worth noting that the global scale, long lag time, and indirect 

nature of the effects of GHG emissions make it particularly difficult to develop a 

reliable benefits estimate, as compared to other CAA pollutants, which have more 

direct and immediate effects. 

133. A 2007legal challenge prompted the courts to direct the government to further quantify 

the costs and benefits of a ton of carbon pollution in federal government rulemakings. 

Specifically, the U.S. Court of Appeals for the 9th Circuit agreed that in quantifying the 

benefit of cutting carbon pollution but admonished that the value is "certainly not 

zero."24 The Cmni asked National Highway Traffic Safety Administration to do a new rule 

that addressed this issue. This court decision bas led the Bush and Obama Administrations 

to further refine a value for the SCC. Do you agree with the reasoning in this decision? 

a. If no, please explain why not and how that would affect how you would approach 

your responsibilities. 

I am not familiar with that decision. As noted above, there are many 

challenges to developing a reliable benefits estimate for GHGs. 

134. In 2009, the Obama administration created an interagency working group (IWG) in an 

effort to create a governmental value for the social cost of carbon, which based its 

calculations on peer-reviewed economic models and expert opinions. The models included 

in their analysis were the Dynamic Integrated Climate-Economy (DICE) 25 , Policy Analysis 

of the Greenhouse Effect (PAGEf", Climate Framework for Uncertainty, Negotiation and 

Distribution (FUND) 27, and World Induced Technical Change Hybrid (WITCH) 28 models. 

The IWG was comprised of scientists and economists from the Office of Management 

Budget, the Council for Environmental Quality, the National Economic Council, the EPA, 

the U.S. Department of Agriculture, Energy, Transportation, and Treasury. 

a. Can you discuss whether you think the models used by the IWG are appropriate 

and credible tools for calculating the social cost of carbon? 

"Centerfor Biological Diversity v. Notional 508 F.3d 508. U.S. Court of 

Appeals for the 9th Circuit(2007). available at IJl_~nJi•.hto1l. 

15 Dynamic Integrated Climate-Economy model (DICE). 

http://www.econ.yale.edu/-nordhaus/homepage/dicemodels.htm 

26 Policy Analysis of the Greenhouse Effect (PAGE), http://climatecolab.org/resources/-/wiki!Main/PAGE 07 The Climate Framework for Uncertainly, Negotiations and Distribution (FUND). http://www.fund-model.org/ 

"World Induced Technical Change Hybrid model (WITCH). http://www.witchmodel.org/ 

Page 54 of 56 
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27172.568

b. Can you comment on whether the IWG was comprised of the right governmental 

stakeholders and actors? 

I am not familiar with the models used by the IWG. I believe it is 

appropriate to be inclusive in establishing a benefits estimate for GHGs. 

135. On March 28,2017, the President issued a Presidential Executive Order on Promoting 

Energy Independence and Economic Growth, which disbanded the IWG, withdrew the 

guidance il issued, and reverted to OMB Circular A-4 of September 17, 2003 (Regulatory 

Analysis). This in effect requires each agency to estimate the value of changes in 

greenhouse gas emissions resulting from regulations. Do you believe the regulatory 

process will be more effective and efficient in the absence of unified guidance on how to 

monetize the value of changes in greenhouse gas emissions? 

Any benefits estimate- even if developed as part of an EPA rule -likely will be 

developed in coordination and con,junction with other departments and agencies. 

136. Part of the social cost of carbon calculation assumes a value for discount rates. The IWG 

after reviewing past OMB guidance recommended using a 3% discount rate ~. 

a. Do you have an opinion on what the discount rate value should be when 

calculating the social cost of carbon? 

b. Scientific research has found that it would be more accurate to use a declining 

discount rate instead of a fixed one. Do you agree that a declining discount rate 

would be more accurate? 

c. Do you have an opinion on what the discount rate value should be used for intergenerational impacts? 

I currently do not have an opinion on the proper discount rate. 

137. Do you believe that it is appropriate for a cost-benefit analysis to consider the harm 

caused in other countries from pollution emitted in the United States? 

The CAA has provisions that address international pollution transport. For example, 

CAA § 179B deals with "international border areas." I believe that international 

pollution transport and effects should be addressed as specified by the Act. 

19 Interagency Working Group on Social Cost of Greenhouse Gases, Techn;ca/ S'upport Document. pp. 15-16. 

Page 55 of 56 
587 


27172.569

Senator Wicker: 

138. As you consider policies at the EPA that affect emissions, will you consider the future 

uses of biomass in the U.S. as part of the power generation mix? Will you consider and 

institute policies related to emissions that will allow new market opportunities for 

American biomass and wood pellet resource? 

Biomass is an important domestic source of fuel for power generation. It has been 

and will continue to be considered as EPA formulates policies and emissions control 

programs for the power sector. 

139. For most of its existence, the ENERGY STAR program has been housed at EPA. Since a 

2009 MOU between EPA and DOE, EPA has been administering the voluntary ENERGY 

STAR program on home appliances. 

I am concerned about the proposals to move the ENERGY STAR program for home 

appliances to DOE. There is the potential that this change could result inefficiencies and 

lead to additional regulatory burdens. In particular, DOE may not update specifications 

to incorporate evolving technologies as EPA has through the voluntary program in 

partnership with stakeholders. 

Can you share your perspective on this issue? 

ENERGY STAR is a unique and successful program. Its ongoing success highly 

depends on maintaining credible specifications for covered products and services. 

Responsibility for implementing ENERGY STAR is split between EPA aud DOE. 

Close coordination is vital to effective program implementation. If confirmed, I 

intend to make such coordination a priority. 

Page 56 of 56 
588 


27172.570

Case Number Title 

08-1277 

American Petroleum Institute v. 

EPA 

08-1281 

Env. Integrity Project v. EPA 

09-1332 

Kinder Morgan C02 Co. LP v 

EPA 

11-1023 

Gas Processors Association v. 

EPA 

11-1309 

American Petroleum Institute et al 

v. EPA 

12-1208 

National Rural Electric Coop. v. 

EPA 

12-1352 

National Rural Electric Cooper v. 

EPA 

12-1405 

American Petroleum Institute v 

EPA 

12-1406 

Gas Processors Associalion v. 

EPA 

12-1442 

American Petroleum Institute et al 

v. EPA 

13-1063 

American Petroleum Institute v. 

EPA 

Wehrum- Pending Cases 

October 12, 2017 

Party Attorney 

American Fuels & Petrochemical 

Manufacturers Association; American 

Petroleum Institute; National 

Petrochemical & Refiners Association; 

Western States Petroleum Association 

American Fuels & Petrochemical 

Manufacturers Association; American 

Petroleum Institute; National Petrochemical 

& Refiners Association 

Kinder Morgan C02 Co., LP 

Gas Processors Association 

American Petroleum Institute; 

Independent Petroleum Association of 

America 

National Rural Electric Cooperative 

Association 

National Rural Electric Cooperative 

Association 

American Petroleum Institute 

American Petroleum Institute 

1111312012 Open 

American Fuel & Petrochemical 

Manufacturers; American Petroleum 

Institute 

American Petroleum Institute 

Originating Case 

Number 

Origin 

EPA-1 : EPA-73FR35838 

Environmental Protection Agency 

EPA-1 : EPA-73FR35838 

Environmental Protection Agency 

EPA-1: EPA-74FR56260 

Environmental Protection Agency 

EPA-1 : EPA-75FR74458 

Environmental Protection Agency 

EPA-1 : EPA-76FR38748 

Environmental Protection Agency 

EPA-1: EPA-77FR10324 

Environmental Protection Agency 

EPA-1 . EPA-77FR34830 

Environmental Protection Agency 

EPA-1 : EPA-77FR49490 

Environmental 

Protection Agency 

EPA-1 : EPA-77FR49490 

Environmental Protection Agency 

EPA-1 : EPA-77FR56422 

Environmental Protection Agency 

EPA-1: EPA-78FR2210 

Environmental Protection Agency 
589 


27172.571

13-1108 American Petroleum Institute EPA-1 : EPA-77FR49490 American Petroleum Institute v. Environmental Protection Agency EPA 

~ation Law Foundation 

National Rural Electric Cooperative EPA-1 · EPA-78FR6674 Association Environmental Protection Agency etal v. EPA 

American Coke and Coal Chemicals 

Institute; American Forest & Paper 

Association; American Iron and Steel 

Institute; American Wood Council; 

Biomass Power Association; Chamber of 

13-1256 Commerce of the United States of EPA-1: EPA-76FR15608 

Sierra Club et al v. EPA America; Corn Refiners Association; Environmental Protection Agency 

National Association of Manufacturers; 

National Oilseed Processors; Rubber 

Manufacturers Association; Southeastern 

Lumber Manufacturers Association 

13-1289 American Petroleum Institute EPA-1 : EPA-78FR58416 American Petroleum Institute v. 

EPA Environmental Protection Agency 

14-1199 National Rural Electric Cooperative EPA-1 : EPA-79FR48072 

PSEG Power LLC, et al v. EPA Association Environmental Protection Agency 

14-1267 Georgia-Pacific LLC EPA-1 : EPA-7gFR60898 

Georgia-Pacific LLC v. EPA Environmental Protection Agency 

15-1021 Gas Processors Association EPA-1 : EPA-79FR70352 Gas Processors Association v. 

EPA Environmental Protection Agency 

15-1044 American Petroleum Institute EPA-1 · EPA-79FR79018 American Petroleum Institute v. 

EP.A, Environmental Protection Agency 

15-1197 American Petroleum Institute EPA-1 . EPA-80FR25068 American Petroleum Institute v. 

EPA Environmental Protection Agency 

15-1473 Gas Processors Association EPA-1 : EPA-80FR64262 Gas Processors Association v. 

EPA Environmental Protection Agency 

15-1487 Brick Industry Association EPA-1 : EPA-80FR65470 

Sierra Club et al v. EPA et al Environmental Protection Agency 

-2-
590 


27172.572

15-1492 Brick Industry Association EPA-1 EPA-80FR65470 

Brick Industry Association v. EPA Environmental Protection Agency 

American Chemistry Council; American 

Coke and Coal Chemicals Institute; 

American Forest & Paper Association; 

American Iron and Steel Institute; 

American Wood Council; Biomass Power 

16-1021 Association; Coalition for Responsible EPA-1 : EPA-80FR72790 

Sierra Club et al v. EPA et al Waste Incineration; Council of Industrial Environmental Protection Agency 

Boiler Owners; National Association of 

Manufacturers; National Oilseed 

Processors Association; Southeastern 

Lumber Manufacturers Association, Inc. 

16-1033 American Fuel & Petrochemical 

American Fuel & Petrochemical e Manufacturers; American Petroleum EPA-1 : EPA-80FR75178 

al v. EPA Institute Environmental Protection Agency 

~~ American Fuel & Petrochemical EPA-1: EPA~OFR75178 Houston et al v. EPA Manufacturers; American Petroleum Environmental Protection Agency I Institute 

16-1179 Brick Industry Association EPA-1: EPA-81FR31234 

isrick~ustrv Association v. EPA Environmental Protection Agency 

~r American Petroleum Institute EPA-1. EPA-81FR35824 can Petroleum Institute v. 

EPA Environmental Protection Agency 

16-1271 American Petroleum Institute EPA-1: EPA-81FR35944 American Petroleum Institute v. 

EPA Environmental Protection Agency 

16-1345 American Petroleum Institute EPA-1: EPA~1FR51102 Amencan Petroleum Institute v. 

EPA Environmental Protection Agency 

16-1425 American Petroleum Institute EPA-1 : EPA-77FR49490 Natural Resources Defense Coun 

v. EPA Environmental Protection Agency 

17-1088 

EP! Utility Air Regulatory Group EPA-1 : EPA-82FR4594 

Utilitv Air Reaulatorv Grouo v. Environmental Protection Agency 

-3-
591 

Senator BARRASSO. Well, thank you very much and congratulations, Mr. Wehrum. 

Mr. Baran, welcome to the Committee. 

STATEMENT OF JEFFERY BARAN, (REAPPOINTMENT) 

COMMISSIONER, U.S. NUCLEAR REGULATORY COMMISSION 

Mr. BARAN. Thank you. 

Chairman Barrasso, Ranking Member Carper, and members of 

the Committee, thank you for the opportunity to appear before you 

today. I am honored to have been nominated to continue my service 

on the Nuclear Regulatory Commission for another term. 

I want to thank my wife, Michelle, and our kids, Mia, Gus, and 

Max for their love and support. My dad, Marty, also deserves special recognition for the many, many hours of Commission meetings 

he has watched online. He probably set some kind of record there. 

When I was confirmed as a Commissioner almost 3 years ago, I 

committed to bringing an open minded and collegial approach to 

the issues that come before the Commission, and I have worked 

very hard to meet that commitment. My focus has been on crafting 

thoughtful, balanced, and timely votes after hearing from a broad 

range of stakeholders. I value the relationships I have formed with 

my Commission colleagues, the NRC staff, licensees, unions, 

States, and public interest organizations, and have benefited greatly from their ideas and input. 

My frequent visits to nuclear plants and other NRC regulated facilities not only give me an opportunity to view equipment and 

technologies firsthand; they also give me the chance to hear directly from NRC’s resident inspectors, as well as the workers and 

managers at the sites about their priorities and concerns. 

If confirmed, I look forward to continuing to serve with Chairman Svinicki and Commissioner Burns. We work very well together. We don’t always agree on policy, but we always have constructive and collegial discussions, and I think that is how the 

Commission is supposed to work, bringing together people with different backgrounds, perspectives, and experiences, and have them 

grapple with tough policy issues together. Ultimately, we make 

sure that important regulatory decisions are carefully and thoroughly considered. 

If they are confirmed, I also look forward to working closely with 

my fellow nominees, Annie Caputo and David Wright. 

Several important initiatives are underway at NRC, and I am 

eager to see them through to their conclusion. If I am confirmed 

for another term, I will continue to focus on these efforts, including 

the power reactor decommissioning rulemaking, implementation of 

post-Fukushima safety enhancements, development of an effective 

and an efficient licensing framework for advanced reactors, and the 

pending small modular reactor design review. 

Managing the Project Aim reductions while fulfilling NRC’s vital 

mission of protecting public health and safety and the environment 

is one of the Agency’s most significant challenges in the coming 

years, so ensuring that the Agency has the resources, talent, and 

leadership to succeed is another top priority for me. I am happy to 

discuss these or any other issues of interest to members of the 

Committee in greater detail today or in the future. 

592 

Prior to my service on the Commission, I had the privilege of 

working for Congress for more than a decade. I have a deep respect 

for the importance and value of congressional oversight. If confirmed, I will continue to do everything I can to ensure that the 

Committee has the information it needs to meet its oversight responsibilities. 

Thank you, and I look forward to your questions. 

[The prepared statement of Mr. Baran follows:] 

593 


27172.573

Jeff Baran 

The Honorable JetfBaran was sworn in as a Commissioner of the 

U.S. Nuclear Regulatory Commission (NRC) on October 14, 2014, and is 

currently serving the remainder of the tenn ending on June 30,2018. 

Since joining the Commission, Commissioner Baran's priorities 

have included ensuring effective implementation of safety enhancements 

in response to the Fukushima Daiichi accident, improving oversight of 

power reactors entering decommissioning, and boosting the openness and 

transparency of agency decisionmaking. He has visited a number of NRClicensed facilities, including operating power reactors, a nuclear plant 

undergoing active decommissioning, a research reactor, fuel cycle 

facilities, a low-level waste disposal facility, and a variety of facilities 

using radioactive materials for medical and industrial purposes. 

Commissioner Baran also traveled to Fukushima Daiichi for a first-hand look at conditions and 

activities at the site. 

Before serving on the Commission, Commissioner Baran worked for the U.S. House of 

Representatives for over 11 years. During his tenure with the Energy and Commerce Committee, 

oversight ofNRC was one of his primary areas of responsibility. As a senior counsel and later as 

Democratic StatfDirector for Energy and Environment, Commissioner Baran worked on a range of 

NRC issues, including new reactor licensing, existing reactor oversight and decommissioning, highlevel and low-level waste, and uranium mining, milling, and enrichment. He worked to coordinate the 

efforts of six federal agencies, including NRC, and two Native American tribes to clean up uranium 

contamination in and around the Navajo Nation. He also helped negotiate bills related to pipeline safety, 

energy efficiency, hydropower, and medical isotopes that were enacted with bipartisan support. From 

2003 to 2008, he was counsel to the House Oversight and Government Reform Committee. 

Prior to his work on Capitol Hill, Commissioner Bamn served as a law clerk for Judge Lesley 

Wells of the U.S. District Court for the Northem District of Ohio. 

Bom and raised in the Chicago area, Commissioner Baran earned a bachelor's degree and a 

master's degree in political science from Ohio University. He holds a law degree from Harvard Law 

School. 

January 2017 
594 


27172.574

Statement of Jeff Baran 

Committee on Environment and Public Works 

September 20, 2017 

Chairman Barrasso, Ranking Member Carper, and members of the Committee, thank 

you for the opportunity to appear before you today. I am honored to have been nominated to 

continue my service on the Nuclear Regulatory Commission for another term. 

When I was confirmed as a Commissioner almost three years ago, I committed to bring 

an open-minded and collegial approach to the issues that come before the Commission. And I 

have worked very hard to meet that commitment. My focus has been on crafting thoughtful, 

balanced, and timely votes after hearing from a broad range of stakeholders. I value the 

relationships I have formed with my Commission colleagues, the NRC staff, licensees, unions, 

states, and public interest organizations, and have benefitted greatly from their ideas and input. 

My frequent visits to nuclear plants and other NRC-regulated facilities not only give me an 

opportunity to view equipment and technologies firsthand; they also give me the chance to hear 

directly from NRC's resident inspectors, as well as the workers and managers at the sites, about 

their priorities and concerns. 

If confirmed, I look forward to continuing to serve with Chairman Svinicki and 

Commissioner Burns. We work very well together. We don't always agree on policy, but we 

always have constructive and collegial discussions. And I think that is how a commission is 

supposed to work. Bring together people with different backgrounds, perspectives, and 

experiences, and have them grapple with tough policy issues together. Ultimately, we make 

sure that important regulatory decisions are carefully and thoroughly considered. If they are 

confirmed, I look forward to working closely with my fellow nominees, Annie Caputo and David 

Wright. 

Several important initiatives are underway at NRC, and I am eager to see them through 

to their conclusion. If I am confirmed for another term, I will continue to focus on these efforts, 

including the power reactor decommissioning rulemaking, implementation of post-Fukushima 

safety enhancements, development of an effective and efficient licensing framework for 

advanced reactors, and the pending small modular reactor design review. Managing the Project 

Aim reductions while fulfilling NRC's vital mission of protecting public health and safety and the 

environment is one of the agency's most significant challenges in the coming years. Ensuring 

that the agency has the resources, talent, and leadership to succeed is another top priority for 

me. I am happy to discuss these or any other issues of interest to members of the Committee in 

greater detail today or in the future. 

Prior to my service on the Commission, I had the privilege of working for Congress for 

more than a decade. I have a deep respect for the importance and value of Congressional 

oversight. If confirmed, I will continue to do everything I can to ensure that the Committee has 

the information it needs to meet its oversight responsibilities. 

Thank you, and I look forward to your questions. 
595 

Senator BARRASSO. Well, thank you all for your testimony. 

Throughout the hearing and with questions for the record, the 

Committee members are going to have an opportunity to learn 

more about your commitment to public service and this nation. I 

would ask that throughout the hearing please respond to the questions, as well as those written questions that will be submitted 

after the hearing. Please submit those for the record. 

I have to ask the following questions that we ask all nominees. 

I do this on behalf of the entire Committee. 

Do you agree, if confirmed, to appear before this Committee or 

designated members of the Committee and other appropriate committees of the Congress and provide information subject to appropriate and necessary security protection with respect to your responsibilities? 

Mr. DOURSON. Yes, I will. 

Mr. LEOPOLD. Yes, I will. 

Mr. ROSS. Yes, I will. 

Mr. WEHRUM. Yes, Mr. Chairman. 

Mr. BARAN. Yes. 

Senator BARRASSO. Do you agree to ensure that testimony, briefings, documents, and electronic and other forms of information are 

provided to this Committee and its staff and other appropriate 

committees in a timely manner? 

Mr. DOURSON. Yes, Senator. 

Mr. LEOPOLD. Yes, Mr. Chairman. 

Mr. ROSS. Yes, I will. 

Mr. WEHRUM. Yes, Mr. Chairman. 

Mr. BARAN. Yes. 

Senator BARRASSO. Do you know of any matters which you may 

or may not have disclosed that might place you in a conflict of interest if you are confirmed? 

Mr. DOURSON. No, Mr. Chairman. 

Mr. LEOPOLD. No, Mr. Chairman. 

Mr. ROSS. No, I do not, Mr. Chairman. 

Mr. WEHRUM. No, Mr. Chairman. 

Mr. BARAN. No, I do not. 

Senator BARRASSO. Based on a prior agreement with the Ranking 

Member, we will have two rounds of questions, not the customary 

one round. Each Senator will have 5 minutes of questions per 

round. I will begin with my questions. 

Commissioner Baran, as you know, in 2013 the U.S. Court of Appeals for the D.C. Circuit ordered the NRC to resume the licensing 

process for Yucca Mountain. The Court found that the NRC, under 

former Chairman Jaczko, had illegally terminated the licensing 

process. Under that Chairman, the NRC argued that it suspended 

the licensing process because it said Congress had not appropriated 

the funds necessary to complete it. The NRC also speculated that 

Congress would not appropriate additional funds in the future. 

In the order, the Court rejected the NRC’s rationale. It explained, ‘‘Federal agencies may not ignore statutory mandates simply because Congress has not yet appropriated all of the money 

necessary to complete a project.’’ The Court also stated, ‘‘An agency 

may not rely on political guesswork about future congressional appropriations as a basis for violating existing legal mandates.’’ 

596 

Well, last month the NRC, under Chairman Svinicki, voted to 

spend funds on activities related to the licensing process of Yucca 

Mountain. The NRC took this step to comply with the Court’s 

order. The NRC took this step on a bipartisan basis, and you were 

the lone person to dissent. You wrote that you did not believe, you 

said, that the NRC should take such a step without knowing 

whether Congress will decide to appropriate funds for the licensing 

proceeding. You suggested that Congress might not appropriate the 

funds. You stated, ‘‘It has been 6 years since Congress last appropriated moneys for the Nuclear Waste Fund.’’ 

Commissioner, I just find your rationale deeply troubling. The 

Court has ordered the NRC to resume the licensing process. Why 

are you following the footsteps of former Chairman Jaczko and 

using a discredited rational—uncertainty about appropriations—as 

an excuse not to follow the law in the courts? 

Mr. BARAN. Well, thank you for the opportunity to clarify my 

vote. Back when the D.C. Circuit looked at this issue, I believe 

there were about $13 million of appropriated funds remaining, and 

at that time the D.C. Circuit said there is more you can do with 

those funds, NRC; you should go ahead and do that; and in the intervening years that is exactly what NRC has done. In that time, 

the NRC staff completed the safety evaluation report, prepared a 

supplemental environmental impact statement that addressed 

groundwater issues, worked on making sure documents were available online that were previously held in the system for the adjudication. 

In that time, the amount of appropriated funds we have left that 

were previously appropriated has dropped to, I think, around 

$600,000 or $700,000. We are also in the midst of some litigation 

that requires the use of some of those funds. 

So the question that was presented to the Commission is does it 

make sense, in fiscal year 2017, to use most of those remaining 

funds to start doing some preliminary steps toward a potential adjudication. My view is that it did not make sense to expend the 

very little that we had left of those Nuclear Waste Fund moneys 

during the fiscal year to prepare for an adjudication until we knew 

whether Congress was going to appropriate funds for the adjudication in fiscal year 2018. 

And I kind of share the view that you expressed, which is that 

we shouldn’t, as a Commission, be making predictions about what 

Congress is going to do. My view is we should wait a few months, 

see what Congress decides to do. Some of the items that would 

have been funded, for example, like a real estate search for a facility to hold the hearing in Nevada, are very kind of short shelf life 

type items, so I didn’t think it made sense to start doing that work 

until we knew we were actually going to begin the adjudication in 

fiscal year 2018. 

Senator BARRASSO. With all due respect, it just seems that agencies do rely on guesswork about appropriations in an effort to comply with the law. What the Court said is that agencies may not rely 

on guesswork about appropriations to avoid complying with the 

law. So I just find it disturbing that perhaps your opposition to 

Yucca Mountain is so strong that you wouldn’t even follow the legal 

court order on this one. 

597 

Mr. Wehrum, last week you argued a case before the U.S. Court 

of Appeals for the D.C. Circuit. You did it on behalf of clients who 

were challenging the Silica Rule. Do you have any concerns that 

this litigation is going to interfere with your work, if confirmed as 

the EPA Assistant Administrator for the Office of Air and Radiation? 

Mr. WEHRUM. No, Mr. Chairman, no concerns whatsoever. The 

issues related to the Silica Rule we were litigating have absolutely 

nothing to do with the issues for which I would be responsible, if 

confirmed to the position of AA for OAR at EPA. 

Furthermore, as we all know, there are comprehensive ethics 

rules that will govern my transition from private practice into Government service. I already am working very closely with EPA’s ethics officers to make sure I fully understand those obligations and 

have their counsel, and I commit that I will strictly follow the regulations that apply to this transition, Mr. Chairman. 

Senator BARRASSO. Thank you very much. 

Senator Carper. 

Senator CARPER. Thanks, Mr. Chairman. 

Again, our thanks to all of you for joining us today and for your 

statements. 

I want to go back to something that Mr. Leopold said, and I 

thought he really nailed it, and I thought he spoke from his heart 

with respect to his commitment to protecting our air and our water 

and our natural resources in this role, if he is confirmed. Here is 

what he said. He said the environmental laws passed by Congress 

in the decades that followed EPA’s creation have been essential to 

securing the promise of environmental and human health protections while at the same time allowing for economic growth and 

prosperity. He went on to say there is no question that EPA has 

made great strides, significantly improving the quality of the air 

we breathe and the waters we depend on. EPA must always continue to make sure that we don’t backslide from these important 

protections. 

When our four nominees for EPA appeared before, I was looking 

for that kind of commitment to protecting our air, our water, our 

natural resources, and I must say I was disappointed not to hear 

it today from at least two of our witnesses, and sadly, not to hear 

it in the meetings that we had in my office. 

I repeated those words because that is the kind of commitment 

we are looking for. That is what we are looking for. 

I have a poster I just want to hold up, if I can, and probably ask 

my first question, if I may, of Dr. Dourson. 

As I mentioned in my opening statement, Dr. Dourson, one of the 

main reasons that Congress worked so hard to reauthorize the 

Toxic Substances Control Act was because everyone recognized that 

EPA needed to have the authority to credibly and impartially assess chemical safety and regulate the chemicals that were found to 

be dangerous. 

This poster shows some examples of the chemicals that you were 

funded by industry to study. In each and every case you concluded 

that the right safety standard for the chemicals should be tens, 

hundreds, even thousands of times less protective, less protective 

than the Federal or State regulators did. It is regrettably difficult 

598 

to look at your record and conclude that you could be an impartial 

regulator. 

One way you could remedy the perception that you may not be 

able to be an impartial regulator would be to promise to recuse 

yourself, if you are confirmed, from working on any chemical that 

industry has paid you, has paid you to study. And I am not interested in a long answer, but I would like a very brief answer. Yes 

or no will do. Would you make that commitment today? 

Mr. DOURSON. Senator, I can give you as many or more examples 

of situations where the science that we brought forward as a team 

actually lowered the safe dose or risk position for various sponsors. 

If confirmed, I will rely on the guidance of EPA ethics officials to 

determine any issues for which I am to be recused. 

Senator CARPER. Let me just say all of us here try to figure out 

the right thing to do and do it: not the easy thing, not the expedient thing. When I apply the ‘‘right thing to do’’ test to this, the 

idea that I represented industry combating EPA on a particular 

substance, and later on I am going to have the opportunity, as part 

of the EPA leadership team, to determine whether or not, presumably impartially, we are going to allow that substance to be approved or in our environment, I would recuse myself. I would just 

say I am going to recuse myself. It wouldn’t be right for me to represent industry opposing EPA with respect to that particular substance and then turn around and go to work for EPA and take the 

other position. I just don’t see why you can’t just say I would 

recuse myself. I don’t get it. 

Mr. DOURSON. Well, Senator, again, the majority of our work is 

done for government organizations, and several of the chemicals up 

there we were doing, we did work with teams of individuals and 

groups, including government and industry organizations. So, 

again, I will rely on the guidance of U.S. EPA ethics officials to determine any issue for which I am to be recused. 

Senator CARPER. Mr. Chairman, I want to just ask unanimous 

consent to submit for the record a list of over 150 organizations 

from across our country who are opposed to Dr. Dourson’s nomination. This list consists of environmental groups, labor groups, 

health, justice and consumer groups, and the American Association 

of Justice. I submit this list for the intention that it will allow the 

record to better reflect the considerable national opposition to his 

nomination. 

Senator BARRASSO. Without objection. 

[The referenced information follows:] 

599 


27172.575

List of groups opposing Dourson: 

I. 5 Gyres 

2. Alaska Community Action on Toxics 

3. Alliance of Nurses for Healthy Environments 

4. *American Academy of Pediatrics 

5. American Association for Justice 

6. *American Congress of Obstetricians and Gynecologists 

7. American Sustainable Business Council 

8. As You Sow 

9. Asbestos Disease Awareness Organization 

10. Black Women's Health Imperative 

II. Blue Green Alliance 

12. Breast Cancer Action 

13. Breast Cancer Prevention Partners 

14. Build a Better Planet 

15. Cape Fear River Watch 

16. Capital District Against Fracking 

17. Catskill Mountainkeeper 

18. Center for Biological Diversity 

19. Center for Environmental Health 

20. Center for Health. Environment & Justice 

21. Center for Progressive Reform 

22. Center for Reproductive Health 

23. Center for Science in the Public Interest 

24. Central California Environmental Justice Network 

25. Citizens' Environmental Coalition 

26. Clean and Healthy New York 

27. Clean Production Action 

28. Clean Water Action 

29. Clean Water Action California 

30. Clean Water Action Connecticut 

31. Clean Water Action Massachusetts 

32. Clean Water Action Minnesota 

33. ClimateMama 

34. Coalition for Clean Air 

35. Collaborative on Health and the Environment 

36. Coming Clean 

37. Comit Civico del Valle 

38. Communications Workers of America 

39. Community Food and Justice Coalition 

40. Conservation Minnesota 

41. Conservation Voters for Idaho 
600 


27172.576

42. Cook Inletkeeper 

43. CRLA Foundation 

44. Democracy Initiative 

45. Earthjustice 

46. Ecology Center 

47. Empire state Consumer Project 

48. Environmental Advocates ofNew York 

49. Environmental Defense Action Fund 

50. Environmental Health Strategy Center 

51. Environmental Justice and Health Alliance 

52. Environmental Working Group 

53. In Our Own Voice: National Black Women's Reproductive Justice Agenda 

54. Farmworker Association of Florida 

55. Farmworker Justice 

56. Farmworker Self-Help 

57. Food & Water Watch 

58. Food Chain Worker's Alliance 

59. Fresnans against Fracking 

60. Friends of the Earth 

61. Global Alliance for Incinerator Alternatives (GAIA) 

62. Grassroots Environmental Education 

63. Green for All 

64. Green Inside and Out 

65. Greenaction for Health and Environmental Justice 

66. GreenFaith 

67. Greenpeace 

68. Headwater LLC 

69. Health Care Without Harm 

70. Health Professionals and Allied Employees 

71. Healthy Building Network 

72. Healthy Legacy Coalition 

73. Healthy Schools Network 

74. Hillsborough Clean Investment Coalition 

75. Hip Hop Caucus 

76. Huntington Breast Cancer ACTION Coalition, Inc 

77. If/When/How 

78. International Association of Fire Fighters 

79. International Center for Technology Assessment 

80. Labor Council for Latin American Advancement 

81. League of Conservation Voters 

82. League of United Latin American Citizens 

83. Learning Disabilities Association of America 

84. Learning Disabilities Association of Georgia 
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85. Learning Disabilities Association of Illinois 

86. Learning Disabilities Association of Maine 

87. Learning Disabilities Association of New Jersey 

88. Learning Disabilities Association of South Carolina 

89. Learning Disabilities Association of Tennessee 

90. Lenape Indian Tribe of Delaware 

91. Los J ardines Institute 

92. *March of Dimes 

93. Marin City Parent Academy 

94. Mi Familia Vota 

95. Migrant Legal Aid 

96. Mixteco Indigena Community Organizing Project 

97. Moms Clean Air Force 

98. National Alliance ofFarmworker Women 

99. National Asian Pacific American Women's Forum 

I 00. National Council of Jewish Women 

I 01. National Health Law Program 

I 02. National Hispanic Medical Association 

I 03. National Institute for Reproductive Health 

I 04. National LGBTQ Task Force Action Fund 

I 05. National Latina Institute for Reproductive Health 

I 06. National Organization for Women 

107. National Partnership for Women and Families 

I 08. National Women's Health Network 

109. National Women's Law Center 

110. Natural Resources Defense Council 

Ill. NextGen America 

112. New Mexico Center on Law and Poverty 

113. New York Environmental Law and Justice Project 

114. NC Child 

115. Nontoxic Certified I Made Safe 

116. North Carolina Conservation Network 

117. Northwest Atlantic Marine Alliance 

118. Northwest Forest Worker Center 

119. Northwest Treeplanters and Farm Workers United 

120. Oil Change International 

121. Oregon Environmental Council 

122. Organizaci6n en California de Uderes Campesinas, Inc. 

123. Organize Florida 

124. PAl 

125. People for Clean Air & Water of Kettleman City 

126. Pesticide Action Network 

127. Physicians for Reproductive Health 
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128. Physicians for Social Responsibility 

129. Planned Parenthood Federation of America 

130. PODER 

131. Power Shift Network 

132. Public Citizen 

133. Rachel Carson Council 

134. Safe Climate Campaign 

135. Safer Chemicals Healthy Families 

136. Safer States 

137. San Francisco Firefighters Cancer Prevention Foundation 

138. Save EPA 

139. Science and Environmental Health Network 

140. Sexuality Information and Education Council of the United States 

141. Sierra Club 

142. Stupid Cancer, Inc. 

143. Texas Campaign for the Environment 

144. Texas Environmental Justice Advocacy Services (TEJAS) 

145. The Environmental Justice Coalition for Water 

146. The Farrnworker Support Committee 

147. The Institute ofNeurotoxicology and Neurological Disorders (INND) 

148. The Progressive Hub, Saratoga 

149. Toxic-Free Future 

150. Toxics Action Center Campaigns 

151. Tri-Valley CAREs 

152. URGE: Unite for Reproductive & Gender Equity 

153. Union of Concerned Scientists 

154. United Automobile, Aerospace and Agricultures Implement Workers of America 

155. United Farm Workers 

156. usw 

157. Utility Workers Union of America 

15 8. Vermont Conservation Voters 

159. Vermont Public Interest Research Group (VPIRG)\ 

160. Warehouse Worker Resource Center 

161. W aterkeeper Alliance 

162. WE ACT for Environmental Justice 

163. West Berkeley Alliance for Clean Air and Safe Jobs 

164. Worker Justice Center of NY 

165. Women's Voices for the Earth 

*These organizations do not take positions on nominees but have sent a letter requesting 

that the Committee ensure the Director of the EPA's Office of Chemical Safety and 
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Pollution Prevention vigorously upholds the mission of the office to protect individuals, 

families, and the environment from potential risks from pesticides and toxic chemicals. 
604 

Senator CARPER. I also want to ask unanimous consent to back 

up the re-nomination of Mr. Baran to submit for the record a release, I guess it was just yesterday, October 3rd, a release from the 

Nuclear Energy Institute, the nuclear industry’s association. This 

press release echoes my support for Mr. Baran and his re-nomination to serve as Commissioner to the Nuclear Regulatory Commission. I ask unanimous consent. 

Senator BARRASSO. Without objection. 

Senator CARPER. Thank you. 

[The referenced information follows:] 

605 


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Nl,J Urges Senntc To Advance NRC Cnnnnis;,ioner Nomination~- Nuclear Energy Institute 

Nuclear Energy Institute 

FOR IMMEDIATE RELEASE: October 03, 2017 

Contact: media@neLorg, 202.739.8000 or 703.644.8805 (after hours and weekends) 

Urges Senate To 

Nominations 

NRC Commissioner 

Print® 

WASHINGTON, D. C.-In a hearing tomorrow the Senate Committee on Environment and Public Works will 

hear testimony in consideration of Jeff Baran to be renominated as commissioner to the Nuclear Regulatory 

Commission. Commissioner Baran's reappointment, joined by the approved nominations for David Wright 

and Ann Caputo, would afford the NRC a full complement of five commissioners at the agency Following is 

a statement from NEI president and chief executive officer Maria Korsnick 

"Today the Nuclear Regulatory Commission is staffed with three committed and safely-conscious 

commissioners. Jeff Baran is one of them. NEI has long held that the industry's regulator is best positioned 

to fulfill its vital mission of ensuring public safety and executing a disciplined licensing process when the 

commission is fully staffed. 

https://nd.org/Ne\vs:·Mt!dia!Mediu~Room/News-Rel~ases'!\El-t:rf!:es~Scnatc-Tn-Ad\·ance-NRC-Conunio.:sioner-Nomin! !0/:l/2017 9:05:56 PMj 
606 


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NLJ Urges SenatG To Advance NRC Commissioner ~ominations ·Nuclear Energy Institute 

"Commissioner Baran has been a strong advocate of safety and transparency and openness in the 

regulatory process. We share this commitment, and we have every expectation that Mr. Wright and Ms. 

Caputo would also meet the expectation of high-quality commissioners the Trump administration and our 

nation expects. 

"This is a moment when Congress and the administration are rightly raising concerns relative to efficient and 

effective federal regulatory environments. The Nuclear Regulatory Commission is most effective when 

operating under the leadership of five well qualified commissioners. and we urge the Senate to move 

expeditiously to achieve that." 

https:!incl.org/Ncv;s-Media/Media-Rl\om!Nev,s-Releases/NEI-\Jrges-Scnatc-To-Advance-NRC-Commissioncr-Nominfl0/3/2017 9:05:56 PMl 
607 

Senator CARPER. Thanks very much. 

Senator BARRASSO. Thank you, Senator Carper. 

For the record, on September 15th of this year, 14 doctors, each 

of whom has won the Arnold Lehman Award, the Society of 

Toxicology’s highest honor, submitted a letter of support for Dr. 

Dourson’s nomination. They wrote, ‘‘Dr. Dourson is highly qualified 

to serve as an Assistant Administrator of the Office of Chemical 

Safety and Pollution Prevention.’’ They go on to say, ‘‘Dr. Dourson’s 

deep understanding of the scientific elements of toxicity testing, 

data interpretation, weight of evidence evaluation procedures, and 

risk assessment is just what it will take to ensure effective implementation of the TSCA reform legislation.’’ 

I ask unanimous consent to enter this letter into the record. 

[The referenced information follows:] 

608 


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The Honorable John Barrasso 

U.S. Senate Environment and 

Public Works Committee 

Majority Office 

410 Dirksen Senate Office Building 

Washington DC 20510 

September 15, 2017 

Dear Chairman Barrasso and Ranking Member Carper: 

The Honorable Tom Carper 

U.S. Senate Environment and 

Public Works Committee 

Minority Office 

4S6 Dirksen Senate Office Building 

Washington, DC 20510 

We are pleased to recommend Dr. Mithael Dourson to you, with enthusiasm and without I'I!Servation, for 

confirmation as the Assistant Administrator of EPA's Office of Chemital Safety and Pollution Prevention (OCSPP). 

Or. Oourson will bring his exceptional knowledge, skills and leadership in the fields of toxicology and risk 

assessment to EPA's OCSPP. Dr. Oourson's contributions to the science and practice of toxicology and risk 

assessme.nt are widely acknowledged, and reflected by the widespread recognition and numerous awards he has 

received from professional societies suth as the Society ofToxicology, the Academy of Toxicologkal Sciences, and 

the Sodety for Risk Analysis. Of particular note, Dr. Dourson received the Arnold J. Lehman Award from the 

Society of Toxicology, the Society's highest honor for scientific achievement In risk assessment and the regulation 

of chemical substances. In reviewing Dr. Oourson's credential> and achievements during the confirmation process, 

his research publications should be judged on the basis of scientific merit, without regard for the funding source, 

just as the Society of Toxicology did when it bestowed upon him the Lehman Award. Dr. Dourson Is highly 

qualified to serve as the Assistant Administrator of OCSPP. 

Best available science, as called for in the legislation, must form 1he foundation of the Agency's Implementation of 

Frank f\. Lautenberg Chemical Safety for the 21st Century Act (LCSA). Dr. Oourson's deep understanding of the 

scientific elements of toxicity testing, data interpretation, weight of evidence evaluation procedures, and risk 

assessment Is just what It will take to ensure effective Implementation of the LCSA. Moreover, as advanced 21" 

century biological profiling and computational methods accelerate toward replacing and augmenting traditional 

animal toxicity tests, there is no one more qualified than Or. Dourson to actualize the promise of these methods 

by creating the collaborations, the scientific confidence evaluation procedures, and the stakeholder education and 

outreach activities that are needed to bring these methods from the research bench Into regulatory use at EPA. 

As scientiSts and fellow Society of Toxicology Lehman Awardees, we urge you to swiftly confirm Dr. Oourson as 

the Assistant Administrator of EPA's Office of Chemical Safety and Pollution Prevention. 

Sincerely, 

Society of Toxicology Lehman Awardees 

Richard A. Becker PhD. DABT Mike Bolger, PhD, DABT 

Thomas W. Clarkson PhD Lorenz R. Rhomberg, PhD, ATS 

Helmut Greim MD ATS Melvin Andersen PhD 

Alan R. Boobis OBE, BSc, PhD, FRSB, FBTS Gary M. Williams, MD, DAI!T 

Samuel M. Cohen MD, PhD, ATS, DABP Bruce N. Ames PhD 

Carole A. Kimmel PhD Harvey J. Clewefl Ill PhD, DABT, ATS 

Dennis J. Paustenbach PhD DAllT Richard H Adamson PhD 
609 

Senator BARRASSO. Senator Inhofe. 

Senator INHOFE. Thank you, Mr. Chairman. 

Mr. Baran, a recent report from the Energy Futures Initiative, 

a group formed by former Secretary of Energy Ernest Moniz, and 

a lot of other people, too, were involved in this, concluded that a 

healthy U.S. civilian nuclear power industry is a national security 

imperative—not opportunity, imperative. The report found, ‘‘The 

nuclear sector helps the U.S. military meet specific defense priorities, supports implementation of U.S. nonproliferation policy, and 

is essential to the global protection of U.S. military capability. The 

flip side is that an eroding nuclear enterprise will compromise nuclear securities capabilities and make them more costly.’’ 

Do you agree that the erosion of the U.S. commercial nuclear 

power industry presents a threat to the United States’ national security? 

Mr. BARAN. As an NRC Commissioner, Senator, it is my job to 

focus on nuclear safety and security, not to weigh in on—— 

Senator INHOFE. No, I think it is an easy answer. Do you believe 

that that is related to our national security? 

Mr. BARAN. Well, again, as a Commissioner, it is not my job to 

weigh in on the pros and cons of the merits of nuclear power. 

Senator INHOFE. All right, let me reword something, then. As the 

former report said, the U.S. ability to influence nonproliferation 

was ‘‘rooted in the historically unique capabilities in U.S. technology, services, and know-how.’’ 

At this time, at this time, Mr. Baran, there is one new nuclear 

plant under active constructive and at least 16 existing nuclear 

plants under the threat of closure. Meanwhile, the rest of the world 

is advancing. We are falling behind. Does this bother you? 

Mr. BARAN. Well, again, it is our job at NRC, we stay focused on 

our mission, which is to ensure the safe, secure use of nuclear 

power to protect human health and the environment. That is our 

focus. It is our responsibility to make sure that we have—— 

Senator INHOFE. You don’t have an opinion on this as to whether 

or not this affects our national security? You have a problem with 

the fact that the rest of the world is passing us up in nuclear 

progress? 

Mr. BARAN. Well, the part I focus on, and my job as a Commissioner, is to make sure we have an effective, efficient process for 

licensing new reactors, and that we do a good job overseeing the 

construction that is underway. 

Senator INHOFE. All right. Thank you very much. 

Mr. Wehrum, in 2015 the Supreme Court found that the EPA, 

under the Obama administration, violated the Clean Air Act by not 

looking at the cost of compliance. This is required, looking at the 

cost of compliance before issuing new regulations on the emission 

of mercury and other toxins from coal fired power plants, as Congress required. That is in the law. In fact, the Clean Air Act calls 

for EPA to conduct ongoing evaluations of job losses, economic 

shifts in costs, and so forth. 

Do you believe that EPA should follow that law? 

Mr. WEHRUM. Senator Inhofe, absolutely. 

Senator INHOFE. You have demonstrated that in the past, haven’t 

you? 

610 

Mr. WEHRUM. I have tried very hard to achieve the dual goals 

of the Clean Air Act, Senator, which is to protect human health 

and the environment, but also promote the economic vitality of this 

nation. 

Senator INHOFE. And if you are confirmed to this position, you 

will do so and continue to do it? 

Mr. WEHRUM. Yes, Senator, I will. 

Senator INHOFE. Mr. Wehrum, you previously served for 6 years 

on the EPA. You did great work, and I thank you for that service. 

Can you talk about a project that you worked on which you are 

most proud? You and I talked about this in the past. I think we 

should share it on the record here. How did that project protect the 

public health and our environment? 

Mr. WEHRUM. Well, Senator, one of the key achievements during 

my time at EPA was implementation of the so-called Tier 4 

Nonroad Rule, which is a comprehensive set of emissions limits 

and fuel requirements for engines in vehicles that are used off the 

highway. That program was unprecedented at the time, achieved 

millions of tons of emissions reductions, and did it in a very smart 

way, such that was also achieved even greater amounts of benefits 

to health and the environment. 

Senator INHOFE [presiding]. It has been very effective. 

Senator Whitehouse. 

Senator WHITEHOUSE. Thank you very much, Chairman. 

Mr. Dourson, the tobacco industry has manipulated and obfuscated scientific research into the dangers of smoking for decades. 

Your name comes up over 460 times in the tobacco industry documents made public as part of the tobacco master settlement agreement. Some of your e-mails are there, corresponding with Philip 

Morris over the work they hired you to do. Even the articles of incorporation for your organization, TERA, are there in the files of 

R.J. Reynolds, with a handwritten note next to your bio that the 

document should be filed under Consultants: Dourson. 

In the late 1990s TERA, the organization you founded, received 

funding from the Center for Indoor Air Research to study the effects of secondhand smoke. TERA’s name pops up throughout the 

tobacco data base, and it has been well documented that the Center 

for Indoor Air Research was a front group for the tobacco industry. 

In 1999 you were the co-author of a paper that underestimated 

the effects of exposure to secondhand smoke in the workplace. To 

reach this industry favored conclusion, you and the other authors 

relied on inappropriately combined exposure data collected from 

workplaces that allowed smoking anywhere and those that allowed 

it only in designated areas, which skewed the results. That study 

is also in the tobacco data base, compliments of the Philip Morris 

collection. 

Can you and will you provide a full accounting of all the work 

you and TERA did for the tobacco industry, all the money you and 

TERA received from the tobacco industry, and the role that you 

played in the campaign to hide the truth about the dangers of 

smoking? 

Mr. DOURSON. Senator, the roles that we played in the tobacco 

work are a matter of public record in the House Science Space and 

611 

Technology 2015 hearing. The total value of our tobacco work was 

approximately $13,000. 

The bottom line is that throughout my career, with EPA, TERA, 

and now with the University of Cincinnati, I have been objective 

in my work and applied sound science to come to my conclusions. 

Senator WHITEHOUSE. And Mr. Wehrum, you have been leading 

the fight against EPA’s air standards, so it is unclear to me how 

you are appropriate to serve in the position to enforce those standards. In particular, Executive Order 13770, Ethics Commitments 

by Executive Branch Appointees, prohibits appointees from participating in any particular matter involving specific parties that is directly and substantially related to their former employer or former 

clients for the first 2 years after their appointment. Your ethics 

agreement states that you intend to sign the pledge. 

We are aware of dozens of separate air cases you have worked 

on during your time at Hunton & Williams. To ensure compliance 

with the pledge, will you provide for the record all of Hunton & 

Williams’ clients and cases or work from the past 2 years, noting 

all clients with whom you have worked, cases on which you have 

worked, and regulatory work you have done? 

Mr. WEHRUM. Senator, as I stated previously, there are comprehensive rules of ethics that govern transition of someone like 

myself from private practice into Government service. I already 

have had extensive conversations with EPA ethics officials, and 

will continue to consult with them closely if this transition goes forward, if confirmed. 

Senator WHITEHOUSE. Do you understand that the Senate has an 

independent role and has a right to independent investigation and 

independent information, that we aren’t just an adjunct of the EPA 

ethics department? 

Mr. WEHRUM. I am sorry, Senator, I missed the beginning of 

your question. I apologize. 

Senator WHITEHOUSE. Do you understand that the Senate has its 

own independent oversight responsibility here and that we are not 

an adjunct to the EPA ethics office? 

Mr. WEHRUM. I understand, Senator, yes. 

Senator WHITEHOUSE. And will you provide the materials to us 

so we can engage in that oversight? 

Mr. WEHRUM. Senator, as I said, my commitment is to understand the comprehensive rules of ethics that apply, to get the best 

advice that I can in understanding what I am required to do and 

to comply with them and to make every effort to strictly comply. 

Senator WHITEHOUSE. Well, that sounds like a no with regards 

to the Senate. 

Did you or your firm do any pro bono work? Pro bono work need 

not be disclosed. Did you do any pro bono work for the Oklahoma 

Attorney General’s Office while Scott Pruitt was the attorney general? 

Mr. WEHRUM. I personally have done no work for the State of 

Oklahoma, and I can’t speak for the rest of my partners and associates; I have never made that inquiry, Senator. 

Senator WHITEHOUSE. You don’t know whether the firm did or 

did not? 

Mr. WEHRUM. I do not know, Senator. 

612 

Senator WHITEHOUSE. Would you provide the Committee a list of 

the firm’s pro bono work so that we can make an assessment of 

whether or not pro bono clients ought to be covered by the ethics 

pledge? At the moment, we simply would never know. 

Mr. WEHRUM. Well, as I said, Senator, there are comprehensive 

rules that apply, very strict, including the voluntary agreement 

that you referred to, which I have committed to sign and—— 

Senator WHITEHOUSE. And which pro bono work does not apply 

to, right? 

Mr. WEHRUM. I am sorry, Senator, I don’t understand your question. 

Senator WHITEHOUSE. The ethics pledge does not require you to 

disclose pro bono work, does it? 

Mr. WEHRUM. I don’t know the answer to that, Senator. I believe 

it applies to any work. There is no difference between pro bono 

work and work that is done for pay. We owe all clients a common 

commitment of zealous representation. 

Senator WHITEHOUSE. Well, my time has gone by. I hope that 

these questions and the independent role of this Committee to do 

oversight is not something that is going to be overrun in the pursuit of getting these nominees in place. 

Senator INHOFE. Thank you. 

Senator Capito. 

Senator CAPITO. Thank you, Mr. Chairman. 

Thank all of you for being here today. 

Dr. Dourson, you have a long career in industrial chemical risk 

assessments, including with your consulting firm. As you know, 

TERA, we talked about this when you came to my office, you have 

been involved with two cases that very much touched the lives of 

my fellow West Virginians, one being the DuPont C8 and Teflon 

manufacturing issues and the other being the Freedom Industry 

spills of 2014, a spill of MCHM and PPH. 

The accuracy of these safety standards, having lived through 

these spills personally, myself, the accuracy of safety standards is 

absolutely critical. It is imperative to have it as quickly as possible 

and as accurately as possible to protect constituents and to also can 

have significant implications for liabilities. 

This issue is particularly sensitive, as I mentioned earlier, so I 

believe that we must conduct rigorous enforcement of appropriate 

safety standards, that we must hold those illegally exposing human 

health and the environment to harmful substances accountable, 

and that we must support timely and effective mitigation and 

cleanup efforts when spills do occur, and we need to apply the lessons of past incidents to prevent a recurrence of harmful spills and 

emissions. 

Do you share those goals, Dr. Dourson? 

Mr. DOURSON. Yes, Senator, I share those goals. 

Senator CAPITO. If you are confirmed, how would you direct the 

Office of Chemical Safety and Pollution Prevention to achieve these 

goals? 

Mr. DOURSON. Well, several of these goals reside in the authorities of other EPA offices, but if confirmed with the Office of Chemical Safety and Pollution Prevention, I will work with other EPA 

offices, as appropriate, to fulfill these goals. 

613 

Senator CAPITO. In the past, in your past work, I would imagine, 

in order to get the appropriate process for setting scientifically 

sound safety levels, that you need to advocate for a transparent 

peer reviewed body of science to back reviews of safe levels of potentially harmful substances. Would you agree with that, and what 

have you done in the past that would convince me that this is the 

direction you would take the office? 

Mr. DOURSON. Well, absolutely I agree with this. TERA, the capacity of TERA as the non-profit 501(c)(3) organization, and then 

University of Cincinnati, we have had over 100 independent peer 

review panels. We have different groups come to the panels, different sector representation. We have well established conflict of 

interest statements, and also we have been reviewed by the EPA’s 

Inspector General in 2009 as a way of showcasing our particular 

independent peer review panel. So I very much agree with your 

views of independent peer review and transparency as paramount. 

Senator CAPITO. Thank you, Dr. Dourson. 

Mr. Ross, you and I talked about intractable water systems. I am 

still on water because we have had some issues. We have a lot of 

kind of abandoned former coal camps where the systems are just 

defunct, but they don’t have the money, or there isn’t the money 

there to maintain or to get them back into compliance. A lot of 

these communities, unfortunately, are under boil water orders, and 

in many cases the EPA continues to issue citations, including fines, 

but there is no real help here for them in an official management 

capacity to get them into compliance, and it is my understanding 

that we really haven’t studied this issue as deeply as we should. 

I am working on a legislative solution to help deal with this 

problem and hope that the EPA will be a willing partner. So, I am 

asking you are you willing to work with me and others to study the 

challenge posed by intractable water systems? 

Mr. ROSS. Yes, Senator, very much so. You have put your finger 

on a very critical priority for me, should I be confirmed, addressing 

these challenges going forward. It is an issue that we addressed in 

Wyoming, we struggle with, and we deal with in Wisconsin, and I 

look forward to working on that at a national level. 

Senator CAPITO. Last, Mr. Ross, I would like to give you the opportunity to respond a little bit to what Senator Carper had mentioned. At least the implication that I heard was that because it 

wasn’t expressly in your statements, several of your statements, 

that you are less committed to the end goal of clean water and environmental safety standards of the highest order, and I would like 

to know if you have a response to that. 

Mr. ROSS. Thank you, Senator, for that opportunity. I do. In fact, 

I wish Senator Carper was here because he gave me a research assignment when I met with him, and to go to him, and the opening 

lines were for the beauty of this earth and for the beauty of the 

skies. And he put his finger on why I do what I do for a living. 

Now, I may disagree a little bit on some approaches, but the ultimate objective I share deeply. So I am fully committed to protecting public health and the environment, should I be confirmed. 

Senator CAPITO. Thank you. 

Thank you, Mr. Chair. 

Senator INHOFE. Thank you, Senator. 

614 

Senator Duckworth. 

Senator DUCKWORTH. Thank you, Mr. Chairman. 

Mr. Dourson, when your nomination was announced in July of 

this year, the Trump administration’s EPA circulated press releases proclaiming that there was a ‘‘widespread praise for Dr. Michael Dourson.’’ Yet, when I reviewed this glowing yet highly misleading document, I was struck by the absence of public health 

leaders and dug a little deeper to figure out why. And I say what 

I found was not pretty. 

From the American Petroleum Institute to the Koch brothers, it 

appears that you have no compunction about accepting millions of 

dollars from the chemical industry to conduct scientific studies on 

their behalf. This included a study conducted in Chicago that was 

paid for by a Koch Industry subsidiary, KCBX Terminals, which is 

an amazing coincidence. Their study concluded that petroleum 

coke, or petcoke, as it is known, which KCBX was pushing into the 

air and lungs of my constituents in the south side of Chicago, was 

unlikely to harm human health. 

This finding, that was bought and paid for by the Koch brothers, 

dramatically diverges from health assessments published last year 

by the U.S. Department of Health and Human Services experts on 

toxic substances and related diseases. Their assessment was consistent with the common sense observations of Illinois families who 

literally could see the chemical byproducts floating in the air that 

they and their children were breathing in. 

My constituents needed experts such as yourself to stand up for 

them and their health, rather than running cover for polluters who 

are wealthy and willing to poison our children as they put profits 

first. 

Now, look, I understand that you were being paid by a client to 

produce a result that would benefit the client’s own financial interests, and frankly, over the years, you seem to have become quite 

good and quite comfortable at producing this type of pseudoscience 

for the highest bidders. But manipulating science to achieve a predetermined outcome is not what the EPA’s Office of Chemical Safety and Pollution Prevention should be about. So you are applying 

for a very different job now. 

In fact, EPA’s own Web site makes clear that petcoke is dangerous to human health. It defies common sense that inhaling toxic 

particulate matter could be anything but poisonous for people, and 

especially for children. 

Olga Batista, one of my constituents who fought for her family’s 

right to clean air, told me, ‘‘When I fought to get the industrial 

petcoke out of our neighborhood in Chicago, Michael Dourson was 

working with Koch Industries to minimize our concerns. To charge 

him with seeing the chemical safety for the entire country might 

be good for families like the Kochs, but it certainly would not be 

good for families like mine.’’ 

Anyone who could turn a blind eye to the environmental injustices that the residents of Chicago have had to bear, as you did, 

does not deserve my support, and I urge all of my colleagues to join 

me in opposing your nomination. 

Mr. Chairman, I would like to ask unanimous consent to submit 

for the record a September 7 article from Midwest Energy News. 

615 

Senator FISCHER [presiding]. Without objection. 

[The referenced information follows:] 

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http:/ /midwestenergynews.com/2017 /09/07 /epa-toxics-nominee-provided-koch-fundedstudy-in-chicago-petcoke-battle/ 

EPA toxics nominee provided Koch-funded study in Chicago pctcoke battle 

WRITTEN BY Kari LydersenSeptember 7, 2017 

PHOTO BY 

Josh Magerman I Creative Commons 

Advocates concerned about pollution from petroleum coke are worried an Ohio professor's study 

downplaying the risks will gain new prominence now that he has been named to a key EPA post. 

In July President Trump announced his intent to nominate University of Cincinnati 

environmental health professor Michael Dourson to head the division of the Environmental 

Protection Agency responsible for chemical safety and enforcing the Toxic Substances Control 

Act. 

Environmental and consumer watchdogs quickly raised concerns about Dourson's history 

working for industry, authoring studies commissioned by DuPont, Dow and other chemical 

companies and the tobacco industry. 

Dourson was also hired by Koch Industries to study the health impacts of petroleum coke 

(petcoke) in Chicago, with his research starting soon after residents began raising concerns about 

the piles ofpetcoke quickly growing at Koch subsidiary KCBX Terminals on the city's 

Southeast Side. 

The study, funded by Koch Industries and carried out by Dourson and two other scientists paid 

by Koch, found no risk of adverse health impacts from exposure to petcoke in the air or on 

surfaces in neighborhoods around KCBX's two pctcoke transfer and storage facilities. 

One of those has since been closed, and the other one was forced by a city ordinance, following 

intense community pressure, to stop storing petcoke in the open. But residents are still concerned 

about petcoke escaping into the air and the Calumet River during the transfer process between 

barges and trains. 

And as they also fight other environmental battles, including around manganese 

contamination from a facility next to KCBX, Dourson's role in the petcoke battle underscores 

the odds residents are up against when fighting big business, especially with such an industryfriendly administration in the White House. 

"I'm not surprised that this person is being promoted. We've seen it happen on the national scale, 

we also see it on the local level," said Olga Bautista, a leader of the Southeast Side Coalition to 

Ban Pctcoke. 
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27172.584

"When you fall in line with these industries and people of power, you get rewarded and put in 

positions that have a lot of influence. And the people who are actually suffering from the 

pollution have very little recourse. They're calling the shots and deciding what is deemed 

dangerous and what is not deemed dangerous. When we try to speak for ourselves and defend 

ourselves, they say we arc not experts." 

KCBX spokesman Jake Reint provided a statement about Dourson's work for the company, 

saying: "Dr. Dourson was one of several experts KCBX retained to make sure our bulk material 

terminals in Chicago were operating in compliance with all rules and regulations, and with 

respect for the environment and our neighbors. This work included analysis of several years of 

air monitoring data and tests on more than I 00 soil and surface samples collected from the 

neighborhoods near the KCBX terminals." 

Science in the service of industry 

The Environmental Defense Fund and Greenpeace USA are an1ong the groups raising alarms 

about Dourson's ties to industry and urging Congress not to confirm his nomination when 

hearings are convened. 

Richard Denison, lead senior scientist for EDF, wrote in a blog post about Dourson's "extensive, 

longstanding financial ties to the chemical industry an industry that, if he is confirmed, he will 

be in charge of regulating. And not only does Dourson have these financial ties to the industry, 

he has made a career of helping industry play down concerns about chemicals." 

Denison said that a review ofDourson's published papers between 2005 and 2017 showed half 

of those where funding sources were revealed were fully funded by industry, and most were at 

least partially funded by industry. These studies covered controversial pesticides and other 

chemicals iliat are currently undergoing EPA review and which Dourson if confirmed would be 

in charge of regulating. 

After Trump's announcement, The Intercept published a chronicle of how Dourson's work for 

DuPont helped the company avoid providing clean water to West Virginia residents after the 

company's chemicals used in making Teflon polluted local groundwater. DuPont later was found 

liable and ordered to pay $1.6 million to a woman who developed kidney cancer linked to the 

contaminated water. 

Petcoke study 

Environmental groups say such a record casts doubt on all ofDourson's work, including the 

petcoke study in Chicago. 

"I certainly wouldn't trust any study he did on its face," said Charlie Cray, a research specialist 

for Greenpeace USA. "It doesn't mean all the work he's done is suspect or biased, but when it's 

underwritten by a company like Koch Industries I would be skeptical from the start." 
618 


27172.585

Dourson and his colleagues sought to monitor petcoke in the air around the facilities and 

accumulated in soil and on surfaces. 

Their paper notes that the only significant study to previously examine health impacts of petcoke 

exposure in humans involved Canadian petroleum workers and found an increased risk of lung 

cancer. But once smoking and asbestos exposure were accounted for among those workers, 

Dourson wrote, petcoke was not found to be a risk factor. 

Since human studies are lacking, Dourson used studies in rats to determine what levels of 

petcoke exposure could be considered harmful. Those studies showed no significant impacts 

from the chemicals in petcoke, including when petcoke was applied to rats' skin. Exposure to 

petcoke dust at certain levels was found to cause accumulation of petcoke in the lungs and lung 

inflammation in rats. 

In November 2013 and April2014, Dourson's team gathered petcoke dust accumulated on 

surfaces in bus stops, parks and rights-of-way near the Chicago petcoke facilities. The study 

determined that chemical indicators of petcoke contamination in the soil and on surfaces were no 

different than baseline accumulation elsewhere in the city. 

Inhalation of particulate matter from petcoke has been the main health concern in the area. 

Particulate matter is known to cause cardiac, respiratory and other health problems regardless of 

the chemical makeup of the material. 

Dourson's study found that based on KCBX's on-site air monitors, the level ofPMIO 

(particulate less than I 0 microns in size) dispersed was not likely to cause health impacts. The 

study concluded that "estimated human exposures, if any, are well below levels that could be 

anticipated to produce adverse health effects in the general population." 

James Brusslan, an attorney who represented residents in a class action lawsuit that ultimately 

resulted in a $1.4 million settlement, disputed those results. He cited research commissioned by 

the city of Chicago and residents' own documentation of petcoke on their property. 

"CDM, an environmental expert retained by the city of Chicago, issued several reports which 

flatly disagreed with the conclusions by Dourson's colleagues and others hired by KCBX that 

KCBX's operations were having little impact on the neighborhood," Brusslan said. "CDM 

determined that KCBX's periphery fence line monitoring was inconclusive, that its bulk sample 

testing had no persuasive value and that any air modeling performed in the area was 

unpredictable. As residents could see with their own eyes, dust from KCBX's facility inundated 

the neighborhood for years." 

CDM's criticisms of Dourson's study include a finding that petcoke dust could migrate off the 

site into residential areas without being logged by the company's on-site air monitors, since it 

might settle on the ground and later be lifted into the air. CDM argued that Dourson's study did 
619 


27172.586

not involve monitors between the company fence-line and the nearest residences, and found that 

PMlO impacts on nearby neighborhoods could be "substantially greater" than Dourson allowed. 

Implications 

By the time Dourson's study was officially published in May 2016, KCBX had already been 

ordered to remove its open piles of petcoke and the class action lawsuit was being settled. 

Brusslan said that Dourson's co-author Lyle Chinkin was involved in the lawsuit proceedings. 

The study notes that Chinkin, along with Dourson and co-author David Macintosh, were 

"retained experts for litigation purposes" for Koch, and "Koch Industries was involved in the 

problem formulation phase of this research." 

Dipro Bhowmik, a researcher for Greenpeace, analyzed Dourson's research record and related 

policy developments in different areas. He theorized that since Koch Industries was forced to 

stop storing petcoke in Chicago, and had previously been forced to stop storage in Detroit, the 

company may hope to use Dour son's findings to combat opposition in other cities or states 

where it seeks to store petcoke. 

"It builds that cache of research that absolves petcoke of health impacts, so in the next 

community that's impacted, the industry is protected," Bhowmik said. 

Public health and environmental watchdog groups have long complained that studies funded by 

industry are entered into the public and legal record as independent research. 

KCBX portrayed Dourson's research this way, including in a statement the company made at the 

time of the class action lawsuit, saying that: "Independent laboratories also have conducted tests 

on more than I 00 soil and surface samples from the neighborhoods near the terminal and found 

no evidence of coal or petcoke dust." 

Bautista noted that community residents have partnered with universities and non-profit 

organizations to do their own data collection and studies, including using balloons for aerial 

mapping and systematic air testing. 

"We've been using DIY methods for collecting data since the onset of this problem, which was 

absolutely crucial in how far we've gotten," said Bautista. "We can be experts in these fields 

because we're the ones who are impacted the most, and we have the most to gain from having 

this information available." 
620 

Senator DUCKWORTH. Thank you. 

This article details the concerns of environmental consumer 

groups about Dr. Dourson’s troubling history of working for Koch 

Industries to the detriment of public health. The article states, ‘‘A 

study funded by Koch Industries and carried out by Dourson and 

two other scientists paid for by Koch found no risk of adverse 

health impacts from exposure to petroleum coke in the air or on 

surfaces in neighborhoods around the company’s two facilities. 

CDM environmental experts retained by the city of Chicago issued 

several reports which flatly disagreed with the conclusions by 

Dourson’s colleagues and others hired by KCBX that KCBX’s operations were having little impact on the neighborhood.’’ 

Mr. Dourson, on EPA’s Web site it states, ‘‘Significant quantities 

of fugitive dust from petcoke storage and handling operations 

present a health risk.’’ Yes or no, do you agree with this statement? 

Mr. DOURSON. Senator, first of all, thank you very much. The 

people of Chicago have every right to—— 

Senator DUCKWORTH. No, reclaiming my time. My question is, 

yes or no, do you agree with the EPA’s Web site as it currently 

states, ‘‘significant quantities of fugitive dust from petcoke storage 

and handling operations present a health risk.’’ Do you agree with 

that, yes or no? You are looking to go to work at EPA. Do you agree 

with what is on their Web site right now? 

Mr. DOURSON. With all due respect, Senator, what we did with 

the city of Chicago was looked specifically—— 

Senator DUCKWORTH. I am not asking about what you did with 

the city of Chicago. I would like to know do you agree with the current statement. And if you are not willing to answer, that is fine, 

but I am asking a very simple question. You are applying for a job 

here at the EPA, and they say on their Web site, right now, ‘‘significant quantities of fugitive dust from petcoke storage and handling operations present a health risk.’’ Yes or no? 

Mr. DOURSON. Senator, I am not really ready to answer that 

question without—— 

Senator DUCKWORTH. OK. Then I don’t think you are ready to go 

work at the EPA. Thank you. 

I yield back. 

Senator BARRASSO [presiding]. Thank you very much, Senator. 

Senator Ernst. 

Senator ERNST. Thank you, Mr. Chair. 

And thank you to all of our witnesses for appearing today. 

Mr. Wehrum, I would like to start with you, please. You had 

stated that Administrator Pruitt had stated, even during his own 

confirmation process, that he will uphold the law. And I know in 

my meetings with Administrator Pruitt he continuously told me 

time and again that he will uphold the law. And last week the EPA 

put forward a Notice of Data Availability that would lower the annual biodiesel blending targets by the number of gallons imported, 

yet still allow those imported gallons to receive compliance credits. 

The EPA is also considering allowing exported ethanol gallons to 

qualify for compliance credits. Both of these moves are contrary to 

the spirit of the renewable fuel standard and would undermine the 

program. 

621 

Administrator Pruitt pledged to me, both in person and before 

this Committee, to enforce the RFS as intended by Congress. Will 

you pledge to uphold the spirit and the letter of this law? 

Mr. WEHRUM. Senator, if I am confirmed, I would look forward 

to working on these issues with you. 

Senator ERNST. It is a law. Will you uphold the law? 

Mr. WEHRUM. As I said in my opening statement, Senator, I 

share the Administrator’s commitment to rule of law. That is a big 

reason why I want to come to EPA and work with Administrator 

Pruitt. He has a palpable commitment to that outcome. The RFS 

is incorporated in the Clean Air Act, and my goal, if confirmed, is 

to understand the law and implement the law. 

Senator ERNST. The intent would be to uphold the law, correct? 

Mr. WEHRUM. Absolutely, Senator. 

Senator ERNST. OK. That is the commitment that Administrator 

Pruitt has given to me, has given to many others, and this Committee, is to uphold the law. And I am hoping that you will also 

uphold the letter of the law, which is the renewable fuel standard. 

Do you believe the major regulatory actions that change the underlying operation of the RFS should be subject to full notice and 

comment period? 

Mr. WEHRUM. Yes, Senator. If the RFS regulations are changed, 

that should be done through notice and comment rulemaking. 

Senator ERNST. Absolutely. Thank you. 

And as part of the EPA’s 2018 RVO Rule, the Agency proposed 

reducing the amount of cellulosic biofuel by 150 million gallons, despite evidence of growing production and demand for the second 

generation biofuel. If confirmed, can you commit to ensuring that 

the cellulosic RVO numbers are based on an objective analysis of 

expected production capability? 

Mr. WEHRUM. Senator, I am going to take half a step back and 

just say this. The RFS is a very complex program, and there are 

extensive provisions within the law that govern how it should be 

implemented, and even more extensive regulations that EPA has 

adopted. So I have to say I know a bit about the RFS. I don’t know 

everything about the RFS. So I said this before, but I really mean 

it, if confirmed, part of what I need to do is fully understand the 

program, and part of what I need to do is fully understand your 

concerns, and I commit to you that I will do that, Senator. 

Senator ERNST. I do appreciate that, and we are happy to assist 

in any way with the education process there. 

The RFS is part of our code, it is the law, and we need to ensure 

that that law is upheld. Regardless of ideology, the goals of the 

RFS should be upheld. It is the law. 

President Trump has repeatedly stated his strong support for the 

renewable fuel standard on multiple occasions, and just a few 

weeks back President Trump made a personal phone call to Senator Chuck Grassley, reemphasizing how much he loves ethanol, 

loves those biofuels, and so far his EPA is on track to meet the 

deadline for annual rulemaking. That is important. 

Will you commit to upholding the timeliness of the yearly renewable volume obligations required under the RFS? 

Mr. WEHRUM. Senator, if confirmed, I will do everything I can to 

make sure we stay on schedule. I understand that there have been 

622 

concerns with that in the past and EPA has had difficulty keeping 

up with the schedule, so, if I am confirmed, I will do everything 

I can to try to keep us on track. 

Senator ERNST. OK. I appreciate your answers very much. We 

will hold Administrator Pruitt to his commitment to uphold the 

law. We will do the same of you. If there is a way that we can be 

helpful in the education process when it comes to the renewable 

fuel standard, I am ready to assist, my staff is ready to assist, and 

I appreciate your commitment. 

Thank you very much, Mr. Chair. 

Senator BARRASSO. Thank you, Senator Ernst. 

Senator Merkley. 

Senator MERKLEY. Thank you, Mr. Chairman. 

Mr. Dourson, chlorpyrifos is a pesticide that is widely used; you 

find it on a lot of the produce in the fresh vegetable aisle at the 

grocery store. A lot of that produce has been sprayed with this. A 

simple yes or no, has chlorpyrifos been linked to brain damage in 

children? 

Mr. DOURSON. Although it would be inappropriate for me to prejudge an issue within U.S. EPA since there are some staff deliberations I am not privy to, if confirmed, I will ensure that the issue 

is fully and fairly—— 

Senator MERKLEY. You have no knowledge about the studies that 

have been done on this insecticide? 

Mr. DOURSON. No, I am knowledgeable of the studies. 

Senator MERKLEY. Has it been linked to brain cancer in peer reviewed studies? 

Mr. DOURSON. I am aware of the studies. 

Senator MERKLEY. Brain damage. Has it been linked in these 

studies? Can you answer yes or no? Has it been linked to brain 

damage in children in peer reviewed studies? 

Mr. DOURSON. There are peer reviewed epidemiology studies that 

show an association in one study and not others. 

Senator MERKLEY. Mr. Chairman, I would like to submit for the 

record the following peer reviewed study showing that chlorpyrifos 

has been linked to brain damage in children. 

Senator BARRASSO. Without objection. 

[The referenced information follows:] 

623 


27172.587

Research i 

Seven-Year Neurodevelopmental Scores and Prenatal Exposure to 

Chlorpyrifos, a Common Agricultural Pesticide 

Virginia Rauh" 1 Srikesh Arunaj'adai,Z Megan Hotton,3'

4 Frederica Perera/:! Lori Hoepn.er,4 Dana B. Barr,5 

and Robin Whyatt 4 

1Hei!brunn Center for Population and Family Health, Mallman School of Public Health, 2Department of Biostatistics, Mailman School 

of Public Health, 3Sergievsky Center, and 4Columbia Genterfor Children's Environmental Health, Mailman School of Public Health, 

Columbia University, New York, New York, USA; 5Emory University, Atlanta, Georgia, USA 

BACKGROUND: In a longitudinal birth rohort study of inner-city mothers and children (Columbia 

Center for Children's Environmental Health), we have pte\'iot~.-.tly reported that prenatal exposure 

to dtlorpyri!m (CPF) was associated with neurodevelopmental pf()b!ems at 3 years of age. 

OSJF.CTWE: 'Ihe goal of the study was ro estimate the relationship brtween prenatal CPF -exposure 

and neurodevelopmeut among (..'Qhort children at 7 years of age. 

METHODS: In a sample of265 children, partidpants in a prospective study of air pollution, we 

measured prenatal CPF exposure usi-ng umbilical cord blood plasma (picograms/gra.m plasma) 

and ?~year neurodevclopment using the W«:hsler Intelligence Scale for Children, 4th edition 

(WISC-IV). Unear regression models were used to estimate associations, with covariate selection 

based on two altemate approru:hes, 

REsULTS~ On a"\<-etage, for each standard deviation increast in CPF exposure (4,61 pg/gJ, Full-Scale 

intelligence quotient (IQ) ®dined by 1.4% and Working Memory declined by 2.8%. Final CQVariates included maternal educational lew!, maternal IQ, and quality of the home environment. We 

fOund no significant !ntetactions between CFF and any covariates, induding the other chemical 

exposures measured during the prenatal period (eilvironmental tobac<:o smoke and polycyclic aromatic hydrocarbons). 

CoNCLUS..lQNS: We repon evidence of dclidts in Working Memory Index and Full-Scale IQ as a 

function of ptenaml CPF CXPQSUie at 7 years uf age, lhese UndlnWl are important in light of mn·' 

tinued widespread we of CPF in agricultural settings and possible longeHerm educational implications of early cognitive deficits. 

KEYWORDS: c:hlotpyrifos, neurodevelopment, pesticides. Em1inm ffettfth Persprtt ll9:l196-120l 

(2011). doi:l0.1289/ehp.l003160 [Online 21 April20lll 

Each 

concerns the possible neuro~ 

insecticides fOr humans derived 

from rodent studies showing that 

and 

toxicity caused by chotinestera.o;e 2011. 

April 

1196 VOLUME 1191NllM!lER B I August 2011 • Environmental Health Perspectives 
624 


27172.588

neurodevdopmental deficits persisting into 

rhe early school years, when more refmcd 

neuropsychological tests arc available ro identifY particular functional impairments. 

Materials and Methods 

Participants and recruitment. The subjects 

for this report are participants in an ongoing 

prospecrive cohort study (Columbia Cmter 

for Children's Environmental Health) of 

inner-cit\' mothers and their newborn infants 

(Perera ~tal. 2002). The cohort study was 

initiated in 1997 to evaluate the effects of 

prenatal exposures to ambient pollutants on 

birth outcomes and neurocognitive development in a cohort of mothers and newborns 

from low-income communities in New York 

City. Nonsmoking women {classified by selfreport and validated by blood cotinine levels 

< 15 ng/mL), 18"·35 years of age, who selfidentified as African American or Dominican 

and who registered at New York Presbyterian 

Medica! Cenrer or Harlem Hospital prenatal 

clinics by the lOth week of pregnancy, were 

approached for consent. Eligible women were 

free of diabetes, hypertension, known HIV, 

and documented drug abuse and had resided 

in the area for at least l year. The study \'las 

approved by the lnstirmiona! Review Board 

of Columbia University. Informed consent 

was obtained from all parricipating mothers, 

and informed assent was obtained from all 

children as well, starting at 7 years of age. 

Of725 consenting women, 535 were active 

participants in the ongoing cohort study at the 

rime of this report, and 265 of their children 

had reached the age of 7 years with complete 

data on the following: a) prenatal materna! 

interview data, b) biomarkers of prenatal CPF 

exposure level from maternal and! or cord 

blood samples at delivery, c) postnatal covariatcs, and d) neurodevelopmental outcomes. 

Maternal interview and assessment. 

A 45~min questionnaire was administered 

to each woman in her home by a trained 

bilingual interviewer during the third trimester of pregnancy and annually thereafter. 

From the interviews and medical records, the 

following sociodemographic and biomedical variables, among others, were available: 

race/ethnicicy, infant sex, household income, 

maternal age, maternal completed years of 

education at child's age 7 years, birth weighr, 

gestational age, and self-reported maternal 

exposure to environmental tobacco smoke 

(ETS) during pregnancy. 

We measured maternal nonverbal intelligence by the Test of Nonverbal Intelligence, 

3rd edition (TONI-3) (Brown et al. 1997), a 

15-min language-free mea.sure of general.intdli~ 

gence, administered when the child was 3 years 

of age. cfhe quality of the care-taking environment was measured by the Home Observation 

for Measurement of the Environment (HOME) 

inventory when the child was 3 years of age 

(Caldwell and Bradley to assess physical and interactive home The 

mother report version of the Child Behavior 

Checklist for ages 6-18 years, a well-validated 

measure of child behavior problems occurring 

in the preceding 2 months (Achenbach and 

Rescorla 2001), was administered at 7 years as 

part of the larger cohort study. 

BioWgic:al samples and pesticide exposure. 

A sample of umbilical cord blood (30,~0 mL) 

was collected at delivery, and a sample of 

matcroal blood {.30--35 mL) was col!ected 

within 2 days postpartum by hospital staff. 

Portions were sent to the Centers for Disease 

Control and Prevention (Atlanta, GA) for 

analysis of CPF in plasma, as well as lead and 

cotinin.:., describ~d in detail elsewhere (Perera 

et al. 2002; Whyau eta!. 2003). Methods for 

the laboratory assay for CPF, including quality 

control, reproducibility, and limits of detection (LODs), have also been previously published (Barr et a\. 2002). In cases where the 

umbilical cord blood sample was not collected 

(12% of subjects), mothers' values were substituted, using a formula previously derived 

from regression analyoes (Whyatt et al. 2005). 

As previously reported, maternal and umbilical 

cord blood CPF concentrations were similar 

(arithmetic means± SDs of 3.9 ± 4.8 pg/g for 

maternal blood and ± 5.7 pg/g for cord 

blood) (Whyatt et 2005), and CPF levels 

in paired maternal and umbilical cord plasma 

samples were highly correlated (r 0.76; 

p < 0.00 l, Spearman's l"ank), indicating that 

CPF was readily transferred from mother ro 

fems during pregnancy. Prenatal blood lead 

levels were available for a subset of children 

(n = 89). ETS expmure, measured by maternal 

self-report, was validated by cminine levels in 

umbilical cord blood, as described in derail 

elsewhere (Rauh er al. 2004). We measured 

polycyclic aromatic hydrocarbon (PAH) exposure by personal air monitoring during the 

third trimester, using a pr~iously described 

method, and excluding poor-quality samples 

(Perera et aL 2003). As previously described 

{Perera et al. 2003), we cnmputed a composite 

log-transformed PAH variable from the eight 

correlated PAH air concentration m~asures 

(r-values ranging from 0,34 to 0.94; a!! p-values 

< 0.001 by Spearman's rank). 

In the larger cohort study, > 40% of 

CPF exposure values for combined materna! and umbilical cord blood samples were 

below the LOD. Using a method suggested 

by Richardson and Ciampi (2003), we made 

a distributional assumption for the exposure 

variable (log-notmal CPF), computed the 

expected value of the exposure (E) for all nondetects [E(XIX < LOD)], and assigned this 

value to all nondetects. 

tl1easures of neurodet'elopment. For the 

7-year assessment, we selected the Wechsler 

Env!ronmi"ntal Hi"alth Pi"Bpectives • VOLUME 1191 Nu~~taE~ a! August 2011 

Neurodevelopment and chlorpyrifos 

Intelligence Scale for Children, 4th edition 

(WISC-IV), because of its revised structure 

based on the latest research in neurocognitive 

models of information processing (Wechsler 

2003). The WfSC-IV is sensitive to lowdose neurotoxic exposures, as dem{)nstrated 

by studies of lead toxicity in 6- to 7.5-yearold children (Chiodo eta!. 2004; Juskn et al. 

2008; Rothenberg and Rothenberg 2005). 

'Ibe instrument measures four areas of mental 

functioning that are associated with, but distinct from, over.aU intelligence quotient (IQ) 

and is sensitive to mgnitive deficits related to 

learning and working memory. which have 

been linked to CPF exposure in rodent studies (e.g., Levin et al. 2002). Each standardized 

scale has a mean of 100 and SO of 15. "rl1e 

Verba! Comprehension Index is a measure 

of verbal concept formation, a good predic~ 

ror of school readiness (Hecht et aL 2000; 

Wechsler 2003); the Perceptual Reasoning 

Index measures nonwrbal and fluid reasoning; the Working Memory Index assesses children's abilicy to memorize new information, 

hold it in short-term memory, concentrate, 

and manipulate information; the Processing 

Speed Index assesses ability to focus attention 

and quickly scan, discriminate, and sequenorder visual information; and the FullIQ score combines the four composite 

indices. The General Ability Index score i~ a 

summary score of genera! intelligence, similar to Full~Scale lQ, but excludes contributions from both Working Memory Index and 

Processing Speed Index (Wechsler 2003}. 

WISC-IV Kores may be influenced by socioeconomic background and/or child behavior 

problems particularly those related to anxiety 

(Wechsler 2003). 

Data analysis. We conducted all 

analyses using the statistical program R 

(R Development Core Team 2010}. We 

treated CPF exposure level (picograms per 

gram) as a continuous variable. We natural 

log (ln) transformed the \XllS(AV Composite 

Index scores to stabilil:e the variance and to 

improve the lineat model fit, Lased on regression diagnostics. Unadjusted correlation analyses were med to explore associations between 

CPF exposure and \'VISC-IV scores. We conStructed smoothed cubic splines to explore the 

shape of the functional relationships between 

CPF exposure and each of the log-transfurmed 

WISC-fV indices. We compared the models in which CPF is entered as a single continuous outcome with those in which CPF is 

modeled using B-splines. using the DavidsonMacK.innon ]-test for comparing nonnested 

models (Davidson and MacKinnon 1981). 

Demographic, biomedical, and chemi~ 

cal exposure variables collected for the larger 

cohort study were available for possible inclusion in the present analysis. We used two differem approaches for covariate selection and 

1197 

• 
625 


27172.589

• Rauh et al 

model fitting, for rhe purpose of determining the robustnrss of our results with respect 

to alternate methods. Covariares were initially selected based on prior literature and 

retained in the models if associated with 

either CPF exposure or the WJSC>IV scales 

(p < 0.10 in univariate analyses). Multiple 

linear regression was used to test the effects 

of prenatal CPF exposure on each 7-year 

WISC>IV 1ndex. We examined residuals for 

normaliry and homoscedasticity and detected 

no problems. In addition, we employed the 

least absolute shrinkage and selection operator (LASSO), a shrinkage with selection pro· 

cedure that provides a more parsimonious 

approach to covariate selection and mode! 

fitting (Houwdingen 2001; Tibshirani 1996). 

This method minimizes the usual mm of 

squared errors, with a bound on rhe sum of 

the absolute values of the coefficients, thereby 

shrinking very unsrahle estimates toward zero, 

excluding redundanrlirrelevant covariates, and 

avoiding overfitting (Zhao and Yu 2006). We 

used Sobel's indirect tc~t to a,<;sess the influence of child behaviors on the estimates of 

CPF effect (MacKinnon et al. 2002; Sobel 

1982). We used Sobel's indirect rest to assess 

mediation (MacKinnon et aL 2002; Sobel 

1982). Jmeraction terms including CPF and 

each additional covariate were tested in the 

models. Effect estimates, 95% confidence 

intervals (Cis), and p-values were calculated 

for all analytic procedures. Results were con-

~idered significant at p < 0.05. 

Results 

'!he retention rate tOr the full cohort was 82% 

at the 7-year follow-up, wirh no significant 

sociodemographk differences between subjects retained in the study and those lost to 

follow-up (data not shown). Table llisrs characteristics of the study sample with complete 

data on all variables (n"' 265). Study families 

were predominantly low income, with 31% 

of mothers failing to complete high school by 

child's age 7 years, aud 66~·0 never married. 

The sample was largely full term (only 4% 

of children in the sample were < 37 weeks 

gestational age at delivery) and included very 

few low-birth-weight infants because R) we 

excluded high-risk pregnancies from the smdy 

cohort, and b) the timing of air monitoring in 

the rhird trimester of pregnancy eliminated 

early deliveries, 

CPF exposure levels ranged from nondetectable to 63 pg/g" We imputed exposure 

levels in participants with nondctectahle CPF 

(n = 115, 43%} according to assay-specific 

LOD values, with 93 subjects having LOD 

equal to 0.5 pg/g and 22 subjects having 

LOD equal to 1 pg/g. 

Correlation analyses for exposures tmd 

cognitive outcomes. Unadjusted correlations between prenatal CPF exposure and 

Table 1. DBmographic characteristics of the samp!B at 7-yearfollaw-up (n= 265) 

Gestatwnalags(weeks) 

Blrthweightlg) 

Ch!ldageattestmg(months) 

Prenatal chemical exposures 

ETS" 

Exposed 

Not exposed 

Cotlrune(ng/mL)1 

lead (~g/dl)l 

CPF(pg/g)1 

PAHs(ng/m3)9 

n!%)armean±SD(range) 

4023±481(23-52) 

175l66) 

90(34) 

93135) 

1?2(65) 

025:~-092(0.01-B?B) 

1 09±,88(0.1&-745) 

317±461 (009-32) 

337±351{05[}--365] 

'As measured by tile HOME mventory. l>completed years of education at child's age 7 years. ~As measured byTON!-3. 

dSelf-reported ra~e/ethfllcity (Airican American"' 1; Dominican~ 0). "Self-reported ever exposed to secondhand smoke inpregnancy(yesoo1;no"'2J.'!v!easuredincordblood.9Measuredbypersonalairsampling 

log-transformed W'ISC-IV Composite Indices 

(Verbal Comprehension, Working Memory, 

Processing Speed, and Perceptual Reasoning). 

and Full-Scale JQ showed significant inverse 

associations between CPF exposure and 

a) Working Memory (r= -O.II,p = < 0.0001) 

and b) Fu!I-Scale IQ (r"' -0.13, p"" 0.02). We 

observed a weak inverse correlation between 

CPF and Perceptual Reasoning (r -0.09, 

p = 0.09), while associations of CPF with Verbal 

Comprehension (r = -0.04) and Processing 

Speed (r= -0.01) had p-values > 0.05. 

Umbilical cord lead was not significantly correlated with CPF level (r "' -0.08, 

p "' 0.49) or WISC-IV scores (all p-values 

> 0.05) among the 89 children with lead data 

available. Lead was not significantly correlated 

with CPF level (r = -0.08, p"' 0.49, as previously reported by Rauh et al. 2006) or with 

7-year WISC-IV scores (aU p-values > 0.05) 

among the 89 children with available data. 

To avoid excluding observations without lead 

data, we did not include lead as a covariate in 

regression models. ETS and (to a lesser extent) 

PAH were correlated with CPF (Spearman 

coefficients: 0.113, p = 0.01, and 0.07, 

p"' 0.09, respectively) but were not significantly correlated (using the Mann-Whitney 

test for the dichotomous ETS variable) with 

any WISC-IV index (coefficients ranged fmm 

-0.02 to 0.03, aod p-values ranged from 0.39 

Birth weight was not significantly 

with any of the WlSC-lV indices 

(all p-vaiues > 0.05) and was not included in 

the final models. 

Spline regression arutlysis. Examination of 

the smoothed cubic spline regression cup:es, 

superimposed over scatterplots, indicates subtle 

differences in shape of the functions (Figure 1). 

1he log-transformed Working Memory Index 

and Full-Scale IQ appear to be approximately 

linear, whereas the other functions show some 

curvature across exposure levels, with sparse 

obserntions at the highest exposures. Using 

the Davidson-MacKinnon test for comparison of non-nested models (Davidson and 

MacKinnon l9Sl), we compared models in 

which CPF was entered as a single continuous outcome with those in which CPF was 

modeled using B-splincs. We failed to reject 

rhe nul! hypothesis that the model with CPF 

as a continuous measure is adequate ;tgainst 

the alternative that the model with CPF 

modeled using splines provided a better fit 

for each WISC-IV Index (p-values: Verbal 

Comprehension Index "' 0.07, Perceptual 

Reasoning Index "' 0.08, Processing Speed 

Index" 0.59, Working Memory Index"' 0.40, 

and Full-Scale IQ"' 0.08). 

Estimation of line4r models. Table 2 lists 

the estimated B-coefficients, 95% Cis, and 

p-values for the exposure variable and covariates for the best-fitting linear regression 

models predicting each WISC-fV outcome. 

1198 voLUME 1191NUMBER 8! August2011 • Environmental Health Persp~tives 
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Neurodevelopmcnt and chlorpynfos 

and does not depend upon !eYe! of general evidence of indirect 

log transformatiOn, associations b~1w~e.11 CPF anJ 

acrual Working Memory and fnll-Scale fQ across the continuum of snnes, 

and 

the estimated decrease in IQ is 

between 0.20 and 0.40 points. The magni-

!tldt of rhcse effects is more easily undersrood 

ncun>dcwlc•nm<mml deficit 

9'5%U.lJ.4HI./lJ 

CPF ~pg/gl 

p < 0.001), the estimate of the C:PF effrct m 15 

n•mained unchanged (-·0.006), and we found CPF(pg/gj 

no evidence of interaction between CPf and 

General Ability lndex (p::. 

that the \'\forking Memory 

CPF{pg/g) 

Environmental Health Perspectives • VOLIJME 119 i ~IJMB£R81August 2011 1199 
627 


27172.591

• Rauh et al. 

subjecrs with detEctable CPF lrvels only. 

Analysis with detects alone is known to give 

unbiased estimates of the parameters of inter~ 

est (Little 1992), In the presenr sample, we 

observed no consistent differences in estimates 

when we excluded imputed CPF dara (data 

not shown). 

Discussion 

Results of this study showed that higher prtc>-

natal CPF exposur.-. as measured in umbilical cord blood plasma, was associated with 

decreases in cognitive functioning on two 

different WISC-IV indices, in a sample of 

urban minority children at 7 years of age. 

Specifically, for each SO increase in exposure 

(4.61 pg/g), Full-Scale IQ declined, on average, by !.4% (0.?4-1.8 poinrs) and Working 

Memory Index scores declined by 2.8% 

(I 6 ·3] points). The dose -t'ffect relationships 

between CPF exposure and !og~transformed 

Working Memory [ndex and Full-Scale IQ 

scores are linear across rhe range of exposures 

in the study population, with no evidence for 

3 threshold. Of the WISC>[V indices used as 

end points, the \Vorking \1emory Index was 

the most strongly associated with CPF exposure in rhis population. 

Although no other epidemiologic studies 

have evaluated the neuroroxiciry of prenatal 

CPF exposure on cognitive development at 

the time of school emry, several prior studies, using rhe present biomarker of e:>;posure, 

have reported evidence of early cognitive and 

behavioral effects associated with a urinary 

biomarker of nonspecific OP exposure (Engel 

et al. 2007; Eskenazi et a!. 20{17; Youn£. et a!. 

200'5). Outcomes associated with ex~;osure 

in these studies, a.> well as in our own earlier work {Rauh et al. 2006), have included 

attentiona! problems (e.g., Marb eta!. 2010). 

Th<!oe prior findings are consisrent with 

-{1006 

-0005 

NAd 

-0002 

NA 

-0002 

LASSO NA 

Fullj'adiusted 0[1()1 

NA,notassessed 

the present 7 -year resu!n, because working 

memory skills involve attenrional processes. 

More imponam, problems in working memory may interfere with reading comprehension, learning, and academiL achkvement, 

although general intelligence remains in the 

normal range (Blair 2006). Working memory 

is l~ss likely than full-scale IQ tub,· affected 

socioeconomic or cultural conditions 

2003), providing 3 useful, more 

targeted measure of possible neurotoxic effects 

on brain function. 

Several diffrtent theork~ or models address 

how working memory operates in the human 

brain, but most agree that it involves a system 

of limited anention capacity, supplemented 

by more peripherally bJsed storage systems 

{Baddeley and Logie 1999). Some thwries 

emphasize the role of attemional control in 

working memory (e.g., Cowan ! 999), whereas 

others stress a muhicomponent model, including a 1:omrol system of limited attentional 

capacity (the central executive control system), 

assisted by phonological and visuospatia! storage systems (see re\'iew by Baddeley 2003). To 

date. most studies of the anatomical localizalion of working memory problems arc based 

on clinical populations (individuals with 

cHic brain le.'>ion.'>) (Va!lar and Pagano 

and some neuroimaging studies in small numbers of normal subjects (Smith and Jon ides 

1997). More refined neuropsychologica!t~sts 

and neuroimaging studie.'> are needed to determine whether CPF-rdated working memory 

deficits arc primarily auditory (part of a phonological loop with implications for language 

acquisition) or primarily related to visuospatial short-term memory (reflecting nonverbal 

imd!igence tasks). 

Few human studies have focused on possible mEchanisms underlying ne:urodevelopme:ntal deficits a~~odated with or exposure, 

~o 009 to-o 002 <0001 

-ODlOto-0002 0003 

NA NA 

-OOO!Jto0001 0(08 

NA NA 

-0006100002 0290 

NA NA 

-0.004to0005 0728 

~lASSO models were adjusted lor maternal educat1on, maternaiiO., and the HOME Inventory. bfully adJusted models 

were adJuSted lor child sex, mcc/ettlnrcrty, maternal !Q, maternal educatron income, chdd age at testrng (mr.mths), ETS, 

and PAH. cA!i scales wereln transformed. d[;PFwas not retamed mthe f,na! lASSO model 

but there is evidence that certain genetic polymorphisms can affect CPF metabolism (e.g., 

Berkowitz ct a!. 2004). Such findings suggest 

that some populations may be more vulnerable and may exhibit adverse neurodevelopmenral effects at much lower exposures than 

other populations (Berkowitz et al. 2004). 

Again, llEilroimaging studies would be useful to determine if population differences 

in vulnerability to CPF are also reflected in 

popub.tion differences in brain abnormalities 

associated with exposure. 

Although behavioral alterations observed 

in rodents may be imperfect analogues for 

humans, they have guidEd human studies 

by identifying specific deficits in locomotor 

aclivity, learning, and memory (e.g., Aldridge 

et al. 2005). In light of experimental evidence 

suggesting that CPF effects in rodents may be 

irreversible (Siorkin 2005), it will be important to determine how any neurocognitive 

ddlcit~ associated with prenatal CPF exposure 

might respond to treatment or early intervention. Here, we may benefit from studies of 

lead-exposed children that have demonstrated 

evidence of reversals in learning deficits as a 

result of environmemal enrichment {Guilarte 

eta!. 2003). 

Some limitations of this study should be 

noted. Our sample consists of low-income. 

urban, minority children who may experience 

other unmeasured exposures or underlying 

health problems that could potentially confound or modil}' associations with pesticide 

e:xpo~ure. Furthermore, in the absence of firm 

mechanistic evidence tinlcing brain anomalies 

w more refined neuropsychological testing, 

the observed functional deficits at 7 vears of 

age should be interpreted with cauti~n. We 

cannot directly cnmpare our findings with the 

results from the other epidemiological studies 

that have relied on urinary OP concentrations 

a;, the biomarker of exposure. 

In June 2000, the U.S, EPA announced 

a phase-out of the sale nf CPF for indoor res· 

idenr!al use, with a complete ban effective 

31 December 2001 (U.S. EPA 2000, 2002). 

After the ban, levels of CPF in personal 

and indoor air samples in our own cohort 

deneased by more than 65%, and plasma 

blood levels dropped by more than 80% 

{Whyatt <!taL 200)), despite &orne lingering residential residues (Whyatt et al. 2007). 

From other pans of the country, ther~ is evidence of continued low-dose exposures in 

children from food residues (Lu et al. 2006). 

Becam.e agricultural use of CPF is still permitted in the United States, it is important that 

we continue to moniror the levels of exposure in potentially vulnerable populations, 

including pregnant women in agricultural 

communities, and evaluate the long-rerm 

neurodevelopmenta! implications of exposure 

w CPF and oth~r OP insenicides. 

I ZOO vowME 119 1 NUMBER 81 August 2011 • Environmental Health Perspectl'ies 
628 


27172.592

Neurodevelopment and chlorpyrrfos • 

Environmental Health Perspectives • vowMt 119 I NlWMR 8! August 2011 1201 
629 

Senator MERKLEY. You have been paid to assess the safety of 

this chemical. Who paid you or TERA to assess the safety of this 

chemical? 

Mr. DOURSON. In 2006, in 2005, we did two manuscripts—— 

Senator MERKLEY. Who paid you? That is the question. 

Mr. DOURSON. It was Dow AgroScience. 

Senator MERKLEY. Thank you. So, my understanding of your organization is that you ultimately recommended a safe level of 10 

micrograms per kilogram per day. That standard is quite different 

from the EPA floor for safety for children ages 1 to 2 of .0017 

micrograms per kilogram per day. In fact, the safety level you proposed in your study, paid for by Dow Chemical, the very same company that makes this chemical, is 5,822 times less protective than 

the level proposed by the EPA. 

I would like to turn to alachlor and acetochlor, two herbicides 

that are widely used. Simple yes or no, have they been linked to 

cancer? 

Mr. DOURSON. We did the study for a collection of industries—— 

Senator MERKLEY. Have they been linked? This is a yes or no 

question. Your knowledge, your background, your life’s work, are 

you aware of these studies linking these chemicals to cancer? 

Mr. DOURSON. I am aware of studies with neurological disturbances with acetochlor. 

Senator MERKLEY. But not cancer? 

Mr. DOURSON. I am not so sure I recall those data. 

Senator MERKLEY. Mr. Chairman, I would like to submit for the 

record the following peer reviewed study linking alachlor and 

acetochlor to cancer. 

Senator BARRASSO. Without objection. 

Senator MERKLEY. Thank you very much. 

[The referenced information follows:] 

630 


27172.611

American Jaurn~;~l of Epidomiolow 

Cop_yrlght © 2004 by the Johns Hopkms Bloomberg Schooi ol Public Health 

A!inghtsreservOO 

Vol.159, No.4 

Printed in U.S.A 

DOl: 10.1093/aje/k.wh040 

Cancer Incidence among Pesticide Applicators Exposed to Alachlor in the 

Agricultural Health Study 

Won Jin Lee1, Jane A. Hoppin2, Aaron Blair1, Jay H. Lubin3, Mustafa Dosemeci1, Dale P. 

Sandler', and Michael C. R. Alavanja1 

1 Occupational and Environmental Epidemiology Branch, Division of Cancer Epidemiology and Genetics, National Cancer 

Institute, National Institutes of Health, Department of Health and Human Services, Rockville, MD. 2 Epidemiology Branch, National institute of Environmental Health Sciences, National Institutes of Health, Department of Health 

and Human Services, Research Triangle Park, NC. 

3 Biostatistics Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, 

Department of Health and Human Services, Rockville, MD. 

Received for publication Ma.y 9, 2003; accepted tor publication July 31, 2003. 

The authors evaluated the incidence of cancer among pesticide app!!cators with exposure to alachlor in the 

Agricultural Health Study, a prospective cohort study of licensed pesticide applicators in Iowa and North Carolina. 

A total of 49,980 pesticide applicators are included in this analysis; 26,510 applicators (53%) reported use of 

alachlor on the enrollment questionnaire. Detailed pesticide exposure and other information were obtained from 

a self~administered questionnaire completed at the time of enrollment (1 993-1 997}. Poisson regression analysis 

was used to evaluate the exposure~response relations between alachlor and cancer incidence controlled for the 

effects of potential confounding factors. A total of 1,466 incident malignant neoplasms were diagnosed during the 

study period, 1993-2000. Among alachlor-exposed applicators, the authors found a significant increasing trend 

for incidence of aU lymphohematopoietic cancers associated with lifetime exposure-days (p for trend= 0.02) and 

intensity~weighted exposure*days (p for trend 0.03) to a!achlor. The risks of leukemia (rate ratio = 2.83, 95% 

confidence interval: 0.74, 10.9) and multiple myeloma (rate ratio =5.66, 95% confidence interval: 0.70, 45,7} were 

increased among applicators in the highest a!ach!or exposure category. Our findings suggest a possible 

association between alachlor application and incidence of lymphohematopoietic cancers among applicators in 

the Agricultural Health Study. 

agriculture; cohort studies; herbicides; leukemia; multiple myeloma; neoplasms; occupational exposure; 

pesticides 

Abbreviations: Cl, confidence interval; OR, odds ratio; SIR, standardized incidence ratio. 

Alachlor (2-chloro-2' ,6' -diethy 1-N-(methoxymethyl)acetanilide) is a pre- and early post-emergent herbicide used 

mainly in the production of com, soybeans, and peanuts (l ). 

Alachlor has been marketed since 1969 under the trade name 

Lasso (Monsanto Company, St. Louis, Missouri). According 

to US Environmental Protection Agency estimates, alachlor 

had an annual usage of7-10 million pounds (1 pound =0.45 

kg) in 1999, making it one of the most widely used herbicides in the United States (2). 

Alachlor produced thyroid (3), nasal (4), and stomach 

cancers (5) in rats presumedly by a nongenotoxic, thresholdsensitive process (6). In 1985, the US Environmental Protection Agency categorized alachlor as a probable human carcinogen (7). There is little epidemiologic information on cancer 

in alachlor-exposed populations, Two retrospective cohort 

studies showed elevated risks for colorectal cancer and 

leukemia among alachlor-manufacturing workers (8, 9). 

However, interpretation of these findings is difficult because 

of the small number of observed cancer cases (n = 23 (8) and 

n = 18 (9)) and the lack of control for potentially confounding 

exposures. 

Reprint requests to Dr. Michael C. R. Alavanja, 6120 Executive Boulevard, EPS 8000, Occupational Epidemiology Branch, Division of Cancer 

Epidemiology and Genetics, National Cancer Institute, Rockville, MD 20852 (e-mail: a!avanjm@mail.nih.9ov). 

373 Am J Epidemiol 2004;159:373-380 
631 


27172.612

374 Lee et aL 

The Agricultural Health Study cohort { 10) will be used to 

comprehensively examine the hypothesized link between a 

wide variety of occupational exposures among farmers and 

commercial applicators and the risk of cancer and other 

chronic diseases. Our overall approach is to evaluate risk 

factors for specific diseases of interest once sufficient 

numbers of expose.d cases have been observed in the cohort 

(e.g., prostate cancer (ll)) and also to evaluate cancer risks 

among selected exposure groups of a priori interest For the 

latter, we first focus on major-use pesticides of biologic 

interest. In this context, we have chosen to examine the 

cancer experience of alachlor applicators because alachlor is 

widely used in US agriculture and it has animal bioassay 

data, which suggest that it may be a human carcinogen. 

MATERIALS AND METHODS 

Cohort enrollment and fotfow*up 

The Agricultural Health Study is a prospective cohort 

study composed of 57 ,3ll applicators licensed to apply 

restricted use pesticides and the 32,347 spouses of private 

applicators from Iowa and North Carolina (10). Recruitment 

of applicators hegan in December 1993 and continued until 

December 1997. Cohort members were matched to cancer 

registry files in lowa and North Carolina for case identification and to the state death registries and to the National 

Death Index to ascertain vital status. Incident cancers were 

identified from the date of enrollment (Le., 1993-1997) 

through December 31. 2000, and coded according to the 

International Classification of Diseases, Ninth Revision 

(12). Cohort members alive but no longer residing in Iowa or 

North Carolina (n = 857) were identified through the current 

address records of the Internal Revenue Service, motor 

vehicle registration offices, and pesticide license registries of 

the state agriculture departments, and they were censored in 

the year they left the state. The average number of years of 

follow-up is 5.5 years. 

Exposure assessment 

A sclf~administered enrollment questionnaire collected 

comprehensive exposure data on 22 pesticides and ever/ 

never use information for 28 more pesticides, as well as 

infonnation on usc of personal protective equipment, pesticide application methods, pesticide mixing, equjpment 

repair, smoking, alcohol consumption. cancer history of 

first-degree relatives, and basic demographic data. (The 

questionnaire may be found at http://www .aghealth.org). 

Questionnaire data from the enrollment and measurement 

data from the published pesticide exposure literature were 

used to calculate the estimated intensity of exposure to indi~ 

vidual pesticides using the formula: intensity level:::: (mixing 

status + application method + equipment repair status) X 

personal protective equipment use (13). We constructed two 

lifetime alachlor exposure variables, each categorized into 

quartiles for this analysis: l) lifetime exposure~days based 

on the number of years applied and the frequency of application u.sing the midpoints of the questionnaire category (i.e., 

years of use X days per year: <19.9, 20.0---56.0, 56.1·-116.0, 

~116.1) and 2) intensity~weighted exposure-days multiplying lifetime exposure-days by exposure intensity level 

(i.e., years of use x days per year x intensity level: <101.9, 

102.0-253.1,253.2-710.4, ~710.5). 

Data analysis 

Prevalent cancer cases (n::: 1,064) and applicators who did 

not provide any infonnation on alachlor use (n = 6,267) were 

excluded from this analysis, leaving 26,510 exposed and 

23,470 nonexposed applicators. Those excluded were 

mainly from North Carolina (69 percent) and were likely to 

have missing data for other variables. 

A standardized incidence ratio for all cancers was calculated as the ratio of observed to expected number of cancer 

cases using standard methods (14, 15). Expected numbers 

for the standardized incidence ratio were estimated from 5-

year age and calendar~timc, race-specific cancer incidence 

rates from the population-based cancer registries in Iowa and 

North Carolina. We also conducted site-specific analysis for 

cancers with five or more exposed cases. 

Poisson regression analysis using the Stata program 

(version 7.0) (16) was conducted while controlling for the 

effect of potential confounding factors to examine internal 

exposure~response relations. Rate ratios derived from the 

analysis were adjusted for age at enrollment (<40, 40-49, 

50-59, 2:60 years), sex, education (high school graduate or 

less, greater than high school), smoking (by pack~years: 

never/low/high), alcohol drinking during the past 12 months 

(yes/no), family history of cancer in first-degree relatives 

(yes/no), state {Iowa/North Carolina), and enrollment year. 

The median value of pack-years among smokers (12 packyears) was used to classify the "low" and "high" categories 

of smokers. The reference group for each rate ratio was the 

lowest level of lifetime exposure-days or intensity-weighted 

exposure-days; applicators who reported not using alachlor 

were excluded from the Poisson regression analyses. Since 

there was potential confounding from other pesticide exposures, we also adjusted rate ratios for the five most highly 

correlated pesticides ( atrazinc, cyanazine, metolachlor, 

trifluralin, 2,4~dichlorophcnoxyacetic acid (2,4-D)), with 

intensity-weighted exposure~days of alachlor (r ~ 0.4). The 

exposure levels of these five pesticides were categorized as 

never, low, and high. The low group and the high group of 

each pesticide were classified by the median intensityweighted exposure-days of each pesticide. Tests for linear 

trend were performed to assess exposure-response patterns 

in each cancer outcome using the method described by 

Breslow and Day ( 17). All significance tests were two sided. 

RESULTS 

Table 1 shows selected characteristics of applicators by 

alachlor exposure. The majority of the cohort are male 

private applicators. Among subjects with complete exposure 

information, 25,532 applicators have used alach1or and have 

information on lifetime alachlor cxposure~days. lltis group 

wa!! divided into two parts, that is, the lowest exposed quar~ 

tile (n = 5,539) and the three remaining exposed quartiles 

(n ::: 19,993). The group with no alachlor use consisted of 

Am J Epidemio/ 2004;159:373--380 

from ht~ps,; /acad<lmic.oup.com/aje/articte-abst:r:act/159/4/37l/77227/Cance.:r:-!ncidence-among-Pesticide~llpplicatcrs 
632 


27172.613

Cancer Incidence and Alachlor Exposure 375 

TABLE 1. Selected characteristics of applicators, by alachlor exposure, based on 1993-1997 enrollment 

data in the Agricultural Health Study 

Age (years) 

<40 

40--49 

50-09 

>60 

Gender 

Male 

Female 

Characteristics 

State of residence 

Iowa 

North Carolina 

Applicator type:j: 

Private 

Commercial 

Smoking history 

Never 

Low (<12 pack-years) 

High (<:12 pack-years) 

Alcohol drinking history§ 

No 

Yes 

Education 

High school or less 

Greater than high school 

Family history of cancer 

No 

Yes 

Corn production 

No 

Yes 

Five pesticides most highly correlated 

with alachlor 

Atrazine 

Cyanazine 

Metolachlor 

Trifluralin 

2,4·011 

Thelowestexp!!sed* 

(n,.,S.539} Otherexposedt 

(n .. 19,993) 

--~---- --------· 

Nonexposed 

{n.,23,470) 

No % No % No. % 

1,647 

1,650 

1,210 

1,032 

5,450 

89 

4,140 

1,399 

5,304 

235 

3,045 

1,239 

1,102 

1,£32 

3,855 

2,859 

2,555 

2,950 

2,305 

1,117 

4.422 

4,390 

2,818 

2,975 

3,353 

4,569 

29.7 

29.8 

21.9 

18.6 

98.4 

1.6 

74.7 

25.3 

95.8 

4.2 

56.5 

23.0 

20.5 

29.7 

70.3 

52.8 

47.2 

SR1 

43.9 

20.2 

7R8 

80.1 

51.3 

54.3 

61.2 

83.7 

5,7{)9 

6,341 

4,478 

3,465 

19,866 

127 

14,387 

5,606 

18,241 

1,752 

10,574 

4,339 

4,542 

5,546 

14,262 

10,842 

8,756 

10,751 

8,184 

3,623 

16,370 

17,647 

11,514 

12,397 

12,686 

17,273 

28.6 

31.7 

22.4 

17.3 

99.4 

0.6 

72.0 

28.0 

91.2 

8.8 

54.4 

22.3 

23.3 

28.0 

72.0 

55.3 

44.7 

56.8 

43.2 

18.1 

81.9 

89.1 

58.0 

62.5 

64.1 

87.5 

9,168 

6,062 

4,255 

3,984 

22,432 

1,038 

15,138 

8,332 

20,893 

2,577 

12,678 

5,117 

4,950 

7,699 

15,371 

12,827 

10,087 

14,005 

8,190 

9,504 

13,966 

11,38:2 

5,314 

6,610 

8,356 

13,993 

39.1 

25.8 

18.1 

17.0 

95.6 

4.4 

64.5 

35.5 

89.0 

11.0 

55.7 

22.5 

21.8 

33.4 

66.6 

56.0 

44.0 

63.1 

36.9 

40.5 

59.5 

49.2 

22.8 

28.4 

36.1 

60.9 

* First quartile of lifetime exposure-days {years of use x days per year). 

t Second, third, and fourth quartiles of lifetime e)(posure-days (years of use x days per year). 

t The term uprivate app!icatorsH refers primarily to individual farmers, and "commercial" refers to professional 

pesticide applicators. 

§ Based on the question, "Did you ever drink any kind of alcoholic beverage during tha past 12 months?". 

112,4-D, 2,4·dichlorophenoxyacetic acid. 

23,470 applicators. The lowest exposed quartile is observed 

to be more similar to the remaining three exposed quartiles 

than to the nonexposed group of applicators on a number of 

Am J Epidemiol 2004;159:373-380 

important variables. These include age, sex, state of residence, family history of cancer, type of farm (com production), and the number of different pesticides used in a 
633 


27172.614

376 Lee et al. 

TABLE 2. Standardized incidence ratios and rate ratios for selected cancers* by alachlor exposure status of the Agricultural Health 

Study applicators, 1993-2000 

Buccal cavity, pharynx {codes 14!}--.149) 22 0.60 0.37, 0.91 23 0.81 0.52, 1.22 0.71 0.34, 1.49 

Esophagus (code 150) 12 0.79 0.41, 1.39 0,35 0.09, 0.89 1.77 0.46, 6.74 

Stomach (code 151) 8 0.51 0.22, 1.01 10 0.82 0.39, 1.50 0.37 0.12, 1.15 

Colorecta! {codes 153 and 154) 87 0.72 0.58, 0.89 72 0.76 059, 0.95 0.82 0.55, 1.21 

Colon {code 153) 61 0.76 0.58, 0.98 49 0.77 0.57, 1.01 0.86 0.54, 1.37 

Rectum (code 154) 26 0.64 0.42, 0.94 23 0.74 0.47, 1.11 0.74 0.36, 1.51 

Uver (codes 155 and 156) 7 1.09 0.44, 2.25 0.96 0.31, 2.25 1.36 0.32, 5.78 

Pancreas {code 157) 13 0.61 0.33, 1.05 14 0.83 0.45, 1.39 0.49 0.20, 1.24 

Larynx (code 161) 0.36 0.14, 0.74 0.26 0.07, 0.67 3.33 0.62, 17.78 

lung (code 162) 83 0.44 0.35, 054 63 0..-11 0.31, 0.52 1.11 0.70, 1.77 

Melanoma (code 172) 38 1.00 0.70, 1.37 20 0.64 0.39, 0.99 1.59 0.83, 3.05 

Prostate (code 185) 325 1.16 1.04, 1.30 246 1.13 0.99, 1.28 1.13 0.91, 1.41 

Testis (code 186) 0.89 0.38, 1.75 11 1.23 0.61, 2.21 0.75 0.25, 2.23 

Bladder {code 188) 30 0.49 0.33, 0.71 25 0.51 0.33, 0.75 1.07 0.54, 2.12 

Kidney (code 189) 23 0.74 0.47, 1.11 24 0.99 0.63, 1.47 0.63 0.28, 1.42 

Brain (codes 191 and 192) 13 0.84 0.44, 1.43 11 0.87 0.43, 1.55 0.99 0.34, 2.90 

Thyroid (code 193) 10 1.27 0.61, 2.33 6 0.90 0.33, 1.97 1.63 0.42, 6.37 

AU lymphohematopoietic cancers (codes 200-208) 70 0.85 0.66, 1.07 65 0.98 0.76, 1.25 0.83 0.54, 1.26 

Non·Hodgkin's lymphoma (codes 200 and 202) 29 0.73 0.49, 1.05 32 1.00 0.69, 1.41 0.50 0.26, 0.94 

Multiple myeloma (code 203) 11 1.04 0.52, 1.87 11 1.30 0.65, 2.33 0.93 0.30, 2,84 

Leukemia (codes 204-208) 26 0.94 0.61, 1.38 19 0.88 0.53, 1.38 1.53 0.72, 3.25 

*Cancer subtypes with fewer than five exposed cases are not shown. 

t lCD-9, lntemaffonal Classification of Diseases, Ninth Revision; SIR, standardized incidence ratio; Cl, confidence interval; RR, rale ratio. 

t: Rate ratio adjusted for age, sex, alcohol, smoking, education, family history of cancer, enrollment year, state ol residence, and the five 

pesticides most highly correlated with alach!or (atrazine, cyanazine, metolachlor, trif!uralin, 2,4-D (2,4-dichlorophenoxyacetic acid)). The 

reference category was applicators who were not exposed to a!achlor. 

lifetime-variables that could be surrogates of important 

occupational and environmental exposures not explicitly 

identified by our study questionnaire but potential 

confounders in our analysis. 

A total of 805 and 661 incident cancers were observed 

among alachlor-exposed and alacblor-nonexposed applica~ 

tors, respectively (table 2). The standardized incidence ratio 

analysis indicates that both the alachlor-exposed (standardized incidence ratio (SIR) = 0.80, 95 percent confidence 

interval (Cl): 0.74, 0.85) and the alachlor-nonexposed 

(SIR= 0.81, 95 percent Cl: 0.75, 0.87) groups show a significant reduced risk of cancer overall compared with those 

expected based on incidence rates in Iowa and North Carolina. This is particularly true for smoking-related cancers, for 

example, lung cancer, for we observed a standardized incidence ratio of 0.44 (95 percent Cl: 0.35, 0.54) among those 

exposed to alachlor and a standardized incidence ratio of 

0.41 (95 percent CI: 0.31, 0.52) among those nonexposed. 

Findings for bladder cancer were similar with a significantly 

reduced risk among those exposed (SlR ::;;: 0.49) and those 

nonexposed (SIR ::;;: 0.51 ). For colorecta1 cancer and cancers 

not typically associated with smoking, a significantly 

reduced risk was observed for both the alachlor-exposed 

group (SIR= 0.72) and the noncxposed group (SIR= 0.76). 

For prostate cancer, a small but similar excess was seen in 

both the exposed (SIR::;;: l.l6) and nonexposed (SIR::;;: 1.13) 

groups. A marginally lower risk for melanoma was observed 

among the noncxposed alachlor group (SIR ::: 0.64) but not 

among those exposed to alacblor (SIR= LOO). 

The non-Hodgkin' s lymphoma risk (rate ratio:::: 0.50) was 

significantly lower than expected when we directly 

compared those exposed to alachlor versus those nonexposed by tbc mean of relative risks controlled for age, sex, 

alcohol, smoking, education, family history of cancer, 

enrollment year, state of residence, and the five pesticides 

most highly correlated with alachlor (table 2). All other relative risks are in the expected range. The results from state~ 

specific analyses were similar (not shown). 

The rate ratios for selected cancers, including those of a 

priori interest (nasal cavity, stomach, thyroid), are reported 

in table 3 by quartiles of lifetime exposure-days and 

intensity-weighted alachlor exposure-days. For all cancers 

Am J Epidemiol 2004;159:373-380 
634 


27172.615

Cancer Incidence and Alach!or Exposure an 

TABLE 3. Rate ratios for selected cancers by lifetime exposure-days and intensity~welghted exposure-days to alachlor among 

Agricultural Health Study applicators, 1993-2000 

All neoplasms Leukemia Multiple myeloma Non·Hodgkln's lymphoma 

-------

~o~:~ RR".t 95%CI* No.ol RR 95%C! No. of RR 95%C! No.ol RR 95%CI No. of RR 95%CI 

Liletimealachlor 

exposure· 

days; 

0.1-19.9§ 148 1.0 " 1.0 1.0 1.0 1.0 

20.0-56.0 221 1.22 0.96, t55 12 0.67 0.27,1-66 0.76 0.19,3.07 0.48 0.04,5.47 0.55 0.12, 2.48 

56.1-116.0 180 1.34 1.04, 1.73 16 1.59 0.70,3.63 1.16 0.28,4.82 1.53 0.20,11.8 6 1.50 0.42,5.40 

?:1161 206 1.27 0,97, 1.65 26 204 0.89,4.65 10 3.01 0.82,11,0 2.99 0.47,19.0 10 1.14 0.30,4.36 

Trend'll 0.08 0.02 0.05 0.14 053 

Intensity-weighted 

a!achlor 

exposure· 

days# 

0.1-101.9§ 169 10 15 1.0 1.0 1.0 1.0 

102.Q-253.1 166 1.37 1.09, 1.74 12 0.99 0.40, 2.44 0.99 0:27.3.58 2.22 0.29, 16.9 0.62 0.11, 3.44 

253.2·-710.4 166 1.42 1.11,1.82 16 2.14 0.95,4.83 0,85 0.19,3.73 1.12 0.09, 14.4 10 2.40 0.65,8.82 

?>.710.5 169 1.11 0.84, 1.46 2.42 1.00,5.89 2.83 0]4, 10.9 5.66 0.70,45.7 1.40 032,6.11 

Trend 0.39 000 0.17 

Bladder cancer Colon cancer Rectal cancer 

No.ol RR 95%C! No. of RR 95%C! No. of 

cases RR 95%CI 

Ufet1mea!acNor 

exposure· 

dayo 

0.1-19.9§ 4 1.0 " 10 1.0 1.0 10 

20.()-56.0 7 1.25 0,30,5.27 17 168 0.89,4,14 0.32 0.06, 1.78 0.27 Q.Q2,3.35 1.17 0.10,13.2 

56.1-116.0 5 1.72 0.40, 7.45 18 2,00 0.79,5.09 1.68 0.48, 5.63 0.25 0.02,3.47 1.53 0.13, 17.8 

;>;116.1 13 3.65 0.92, 14.5 13 062 0.20, 1.99 0.71 0.16,3.11 0.49 0.05, 4.78 1.27 0.10,16.4 

Trend 0.03 0.53 0.77 063 0.62 

Intensity-weighted 

alach!or 

exposure-

,., (1.1-101.9§ 4 10 14 1.0 1.0 1.0 1.0 

102.0-253.1 6 3.11 0.79, 12.3 1.36 0.56,3.34 1.68 0.46, 6.17 2.17 0.19,24.9 

253,2-710.4 10 3.64 0.89, 14.8 16 1.85 0,76,4.50 0.75 0.15, 3.73 0.20 0.02,2,52 0.93 0.05,16.5 

;>;710,5 7 2.03 0.41,10.0 17 1.14 0.40,3.23 1.07 0.23,5.07 0.22 0.02,2,26 2.89 0.22,38.7 

Trent! 0.64 0.83 

* RA,rate ratio;C!,conlldenceinterval 

t Rate ratio adjusted for age, sex, alcohol, smoking, education, family history ol cancer, enrollment year, state of residence, and the live pesticides most highly 

correlated With alach!or (atrazine, cyune.zine, metolachlor, tnfluraltn, 2,4-D (2,4-tltchlorophenoxyacetlc actd)). 

1: Lifetime exposure-days"' years of use x days per year 

§Aelerencegroup. 

'!lpva!uefortrendtest. 

# Intensity-weighted exposure-days= years of use x days per year x inlonS1ty intlex. 

combined, there was no trend of increasing risk with 

increasing exposure. A significant exposure~response trend 

was observed for all lymphohematopoietic cancers 

combined using either the lifetime exposure-days or intensity~weighted exposure-days, rising to an over twofold 

increased risk in the highest category. The risks of leukemia 

and multiple myeloma were markedly increased in the 

highest exposure category, although they had wide confiAm J Epidemiol 2004;159:373-380 

dence intervals. These results were not changed when we 

added "total years of pesticide application" to the multi~ 

variate analysis as a surrogate measure of other potential 

farming exposures (data not shown). A significant trend for 

bladder cancer was observed for the lifetime exposure-days 

but not the intensity~weighted exposure-days. Similar analyses for other cancers did not suggest associations. An analysis that was restricted to private applicators living in Iowa 
635 


27172.616

378 Lee eta!. 

yielded results similar to those reported in table 3, The 

results for North Carolina applicators were unstable as a 

result of smaller numbers of cases. 

DISCUSSION 

We found significant positive exposure-response trends 

among pesticide applicators exposed to alachlor for all 

lymphohematopoietic cancers combined, using two exposure measures (i.e .. lifetime exposure-days and intensityweighted exposure-days). Among the lymphohematopoietic 

cancers, leukemia and multiple myeloma showed this pattern 

independently, but the numbers were smalL The findings 

were similar when we repeated the exposure-response analyses restricting the study population to Iowa or to private 

applicators. 

Elevated risks for all lymphohematopoietic cancers (SIR= 

3.6, 95 percent CI: 1.2, 8.5) and chronic myeloid leukemia 

(SIR= 25.0, 95 percent Cl: 3.0, 90.3) have been reported for 

alachlor-manufacturing workers (9). A subsequent analysis 

of these manufacturing workers also showed an increased 

risk for chronic myeloid leukemia (8). However, populationbased case-control studies have shown no significant association between alachlor exposure and leukemia (odds ratio 

(OR)= !.0, 95 percent Cl: 0.7, !.5) (18), noo-Hodgkio's 

lymphoma (OR = 1.2, 95 percent Cl: ll.8, !.7) (19), or 

multiple myeloma (OR= 0.9, 95 percent Cl: 0.5, 1.7) (20). 

As with many population~based caseMcontrol studies, these 

were limited by the relatively small numbers of exposed 

cases and the fact that exposure assessment was conducted 

after disease diagnosis. 

There is some evidence of a genotoxic effect of alachlor in 

experimental systems. ln mammals, alachlor induced chroM 

mosomal aberrations in bone marrow cells of Wistar rats 

treated in vivo (21) and in cultured Chinese hamster ovary 

cells (22). Increased thyroid, stomach, and nasal tumors 

were observed in Long-Evans and Sprague-Dawley rats 

associated with alachlor exposure (3-6). Alachlor also has 

been found to cause chromosomal damage in human 

lymphocytes (21, 23) exposed in vitro. 

Our standardized incidence ratio analysis of those exposed 

and those nonexposed to alachlor indicates that the two 

groups are both at significantly reduced risk of cancer 

overall and particularly to smoking-related cancers of the 

lung and bladder. A similar reduced risk is observed among 

both groups for colorectal cancer, which may in part be due 

to the more physically active work of farmers and commercial pesticide applicators compared with other residents of 

Iowa and North Carolina. The fact that melanoma is marginally lower than expected among the noncxposed group and 

not among the exposed group may indicate that nonexposed 

cohort members arc less frequently exposed to excess 

sunlight exposure. Although comparing all those ever 

exposed with those never exposed to alachlor in a standardized incidence ratio analysis can establish whether the two 

groups have similar cancer risk profiles, standardized incidence ratios are a relatively insensitive indicator of occupational risk because they cannot adequately control for 

significant confounding factors and have well-established 

"healthy worker'' problems. The significantly lower risk of 

non-Hodgkin 's lymphoma observed among those exposed to 

a1ach1or compared with those not exposed while controlling 

for age, sex, alcohol, smoking, education, family history of 

cancer, enrollment year. state of residence, and the five most 

highly con·eJated pesticides with alachlor is unexpected. 

This "protective effect" of alachlor is not observed in the 

subsequent dose-response analysis described in table 3, and 

it is likely therefore to be a statistical artifact due to either 

chance or residual confounding resulting from exposure not 

explicitly identified by our questionnaire. 

Although a significant 1.3-fold risk for all cancers 

combined was found among applicators in the second 

highest category of lifetime exposure to alachlor, the lack of 

a monotonic exposure-response relation suggests that this 

increase may be due to chance. Moreover, we did not find 

increased cancer risks for several sites of a priori interest that 

were positive in anima] bioassays including the nose, 

stomach, and thyroid gland. Since the number of observed 

cases at these sites was small during our short follow-up 

study, continued follow-up is warranted. Although the use of 

positive animal bioassays to indicate the potentially important biologic activity of a chemical is standard practice. 

extrapolating organ site-specific experimental results to 

humans is problematic because of differences in human 

metabolism, physiology, and environmental conditions (24). 

A previous cohon study (9) reported increased risk (SIR) 

for colorectal cancer among alachlor~manufacturing 

workers. However, Acquavella et al. (8) suggested that the 

association between alachlor and colorcctal cancer was 

noncausal because they did not observe any cases in a highly 

exposed department and because the colon plays only a 

minor role in a1ach1or metabolism and excretion. We saw no 

excess for colorectal cancer in the standardized incidence 

ratio analysis nor any trend by level of exposure. 

Our observation of a slightly increased standardized incidence ratio for prostate cancer among both alachlor~exposed 

and alachlor-nonexposed applicators is consistent with a 

previous report from this study and with results from other 

studies of fanners (25~30). Recently, Alavanja et al. (II) 

reported that chlorinated pesticides and methyl bromide (but 

not alachlor) were significantly associated with an excess 

risk of prostate cancer in this cohon. We did not see any 

association between alachlor and prostate cancer in the 

Poisson analyses. 

An increasing trend for bladder cancer associated with 

lifetime exposure-days was observed. The lack of a corresponding increase with the intensity-weighted exposuredays is difficult to explain but argues against a causal relation. 

Overall, 17 percent of applicators in this cohort are current 

smokers, which rate is lower than for the United States as a 

whole (28 percent for males and 23 percent for females) 

(31). The observed deficits for smoking-related cancers, 

such as cancers of the lung, bladder, larynx, and buccal 

cavity, compared with rates for the general population in 

Iowa and North Carolina are consistent with the low prevalence of smoking in the Agricultural Health Study cohort. 

Our exposure-response analyses arc adjusted for tobacco use 

and other potentially important confounders. 

Am J Epidemiol 2004;159:373-380 
636 


27172.617

Although the period of cohort follow-up is still relatively 

short (5,5 years on average), this study has several important 

strengths. The Agricultural Health Study is the largest study 

of pesticide applicators exposed to alachlor conducted to 

date. All exposure infonnation was collected prior to the 

diagnosis of cancer, which obviates case-recall bias. This 

study included comprehensive questionnaire data that were 

used to quantitatively estimate alacblor exposure levels and 

to control for potential confounding ( 10, 13). 

A limitation of this study and almost all studies of pesticide users is that persons who apply pesticides are seldom 

exposed to just a single agent and that potential confounding 

is, therefore, possible. Coble et aL (32) evaluated the relations among different agricultural exposures and found that 

substantial bias due to confounding from exposure to 

multiple agents was unlikely in this cohort. However, the 

significant difference observed between alachlor users and 

nonusers (table 1) for age, gender, state of residence, applicator type, family history of cancer, corn production, and 

other coexposure to pesticides suggests the possibiliry that 

unrecognized residual confounding may bias the doseresponse relation in our analysis. To mitigate the possibility 

of residual confounding, we chose the lowest alachlor expo~ 

sure group as the referent in our rate ratio analysis rather than 

the nonexpos.ed group, and we adjusted the lymphohematopoietic risk estimates by including the five pesticides most 

highly correlated with alachlor in our models. 

A total of 857 (less than 1 percent) cohort members left the 

states of Iowa and North Carolina during the period of the 

study from 1993 through 2000, and any cancers resulting 

from this group are lost to the state cancer registry. This 

sma11 portion of the total cohort is younger and more 

educated, smokes less, and has a slightly lower frequency of 

family history of cancer than the total cohort (data not 

shown) and is therefore likely to generate proportionally 

fewer cancers than the rest of the cohort. To assess the 

magnitude of the potentia! bias caused by having this group 

of low~cancer-rL~k study subject leave the cohort. we recalculated our risk estimated by adding all the lost person~ years 

generated by this group to the denominator and assumed no 

cancer cases in the numerator. We observed only mirrimal 

changes in our risk estimates that did not affect our conclusion. 

Additionally, the formulation and use of alachlor muy 

have changed over the years. These factors create a potential 

for some exposure misclassification. particularly in studies 

where exposure is based on subject recalL Subjects in this 

study were asked to recall pesticide usc over their lifetime. 

Recall of pesticide use by the Agricultural Health Study 

cohort has been shown to be similarly reliable to that for 

other factors routinely evaluated by questionnaire in epidemiology studies, such as smoking and alcohol use, and to be 

better than others, such as consumption of fruits and vegetables and physical activity (33). Hoppin et al. (34) also 

demonstrated that participants in our cohort provided plausible information regarding the duration of use of specific 

pesticides. 

Our study had relatively low statistical power to detect 

excess risks for less common cancers. The statistical power 

to detect a 1.5-fold increase in the incidence of cancers of a 

Am J Epidemio/ 2004;159:373-380 

Cancer Incidence and Alachlor Exposure 379 

priori interest varied by site, from 75 percent for lymphohematopoietic tissue to 63 percent for colon, 17 percent for 

stomach, and 12 percent for thyroid cancer. 

Although the interpretation of our results is limited by a 

small number of cases, our findings suggest a possible asso~ 

dation between alachlor application and the incidence of 

lymphohematopoietic cancers~in particular leukemia and 

multiple myeloma-among applicators in the Agricultural 

Health Study. Additional follow-up of this cohort will shed 

further light on the risks for these and other cancers as the 

number of cancer cases increases over time. 

REFERENCES 

I. Hayes WJ Jr, Laws ER Jr. cds. Handbook of pesticide toxicology. Vol 3. Classes of pesticides. New York, NY: Academic 

Press, Inc. 1991:1341-3. 

2. Donaldson D, Kiely T, Grube A. Pesticide industry sales and 

usage: 1998 and 1999 market estimates, Washington, DC: 

Environmental Protection Agency, 2002. (http://www.epa.gov/ 

oppbcadl!pestsales/99pestsalcs/market_estimatesl999.pdf). 

3. Wilson AG, Thake DC, Heydens WE, et al. Mode of action of 

thyroid tumor formation in the male Long-Evans rat administered high doses of alachlor. Fund am Appl Tox.icol1996;33: 

16-23. 

4. Genter MB, Bunnan DM, Dingeldcin MW, ct al. Evolution of 

alachlor-induced nasal neoplasms in rhe Lcng-Evans rat. 

Toxicol Pathol 2000;28:770-81. 

5. Thake DC, latropoulos MJ, Hard GC. et al. A study ofthe 

mechanism of butachlor~associated gastric neoplasms in 

Sprague-Dawley rats. Exp Toxicol Pathol1995;47:107~16. 

6, Heydens WF, Wilson AG, Kier LD, et al. An evaluation of the 

carcinogenic potential of the herbicide alachlor to man_ Hum 

ExpToxicoll999:18:363-91. 

7. Special review of certain pesticide products-alachlor. Springfield, VA: Office of Pesticide Programs, Environmental Protection Agency, 1985, (Document no. PB85-175503). 

8. Acquavella JF, Riordan SG. Anne M, et aL Evaluation of mortality and cancer incidence among alachlor manufacturing 

worlrers. Environ Health Perspect 1996;104:728-33. 

9. Leet T, Acquavella J, Lynch C. et al. Cancer incidence among 

alach!or manufacturing workers. Am J Ind Med 1996;30:300-

6. 

10. Alavanja MC, Sandler DP, McMaster SB, et al. The Agricultural Health Study. Environ Health Perspect 1996;104:362-9. 

11. Alavanja MC, Samanic C, Doscmeci M, et aL Use of agricultural pesticides and prostate cancer risk in the Agricultural 

Health Study cohort Am J Epidemiol2003;157:800-I4. 

12. World Health Organization. International classification of dis· 

cases. Manual of the international statistical classification of 

disease;,, injuries, and causes of death.Ninlh Revision_ Geneva. 

Switzerland: World Health Organization, 1979. 

13. Dosemeci M, Alavanja MC, Rowland AS, eta!. A quantitative 

approach for estimating exposure to pesticides in the Agricul~ 

tural Health Study. Ann Occup Hyg 2002;46:245-60. 

14. Udell F. Simple exact analysis of the standardized mortality 

ratio. J Epidemiol Community Health 1984;38:85-8. 

15. Monson RR Occupational epidemiology. 2nd ed. Boca Raton, 

R..: CRC Press. 1'990:105-3L 

16. StataCorp. Stat a reference manual: release 7. College Station, 

TX: Stata Press. 2001. 

17. Breslow NE, Day NE. Statistical methods in cancer research. 

Vol IT. The design and analysis of cohort studies_ Lyon, France: 
637 


27172.618

380 Lee et aL 

International Agency for Research on Cancer, 1987:91-103. 

{!ARC scientific publication no. 82). 

18. Brown LM, Blair A, Gibson R, et al. Pesticide exposures and 

other agricultural risk factors for leukemia among men in Iowa 

and Minnesota. Cancer Res 1990;50:6585-91. 

19. CantorKP, Blair A. Everett G, et al. Pe~ticides and other agricultural risk facton> for non-Hodgkin's lymphoma among men 

in Iowa and Minnesota. Cancer Res 1992;52:2447-55. 

20. Brown LM, Bunneister LF, Everett GD, et al. Pesticide exposures and multiple myeloma in Iowa men. Cancer Causes Control 1993;4: 153-6. 

21. Georgian L. Moraru I, Draghicescu T, et at. Cytogenetic effects 

of alachlor and mancozeb. Mutat Res 1983; 116:341-K 

22. Lin MF. Wu CL, Wang TC. Pesticide clastogenicity in Chinese 

hamster ovary cells. Mutat Res 1987; 188:241-50. 

23. Meisner LF, Belluck DA, RoloffBD. Cytogenetic effects of 

alachlor and/or atrazine in vivo and in vitro. Environ Mol Mutagen 1992;19:77-82. 

24. Madlc S, Obe G. Methods for analysis of the mutagenicity of 

indirect mutagens/carcinogens in eukaryotic cells. Hum Genet 

1980;56:7-20. 

25. Blair A. ZahmSH. Cancer among fanners. Occup Med 1991;6: 

335-54. 

26. Blair A, Zahm SH. Agricultural exposures and cancer. Environ 

Health Perspcct 1995; l03(suppl 8):205-8. 

27. Morrison H, SavitzD, Semeneiw R. etal. Farming and prostate 

cancer mortality. Am J Epidemiol 1993; 137:270-80. 

28. Aronson KJ, Siemiatycki J. Dewar R, eta!. Occupational risk 

factors. for prostate cancer: results from a case-contml study in 

Montreal, Quebec, Canada. Am 1 Epidemiol1996;l43:363-73. 

29. Keller-Bymc JE, Khuder SA, Schaub EA. Meta-analyses of 

prostate cancer and farming. Am J Ind Med 1997;31 :580-6. 

30. Acquavella J, Olsen G, Cole P, et aL Cancer among fanners: a 

meta~analysis. Ann Epidcmioll998;8:64-74. 

31. Centers for Disease Control and Prevention. Smoking and 

health: United States National Health Interview surveys, 

selected years 1965-1991. Atlama, GA: Centers for Disease 

Control and Prevention, 1995. 

32. Coble J, Hoppin JA. Engel L. ct al. Prevalence of exposure to 

solvents, metals. graJ n dust, and other hazards among farmers 

in the Agricultural Health Study. J Expo Anal Environ Epidemio\2002;12:418-26. 

33. Blair A. Tarone R, Sandler D, et al. Reliability of reporting on 

life-style and agricultural factors by a sample of participants in 

the Agricultural Health Study from Iowa. Epidemiology 2002; 

!3;94-9. 

34. Hoppin JA, Yucel F, Doscmed M, et al. Accuracy of self· 

reported pesticide use duration infonnation from licensed pesticide applicators in the Agricultural Health Study. J Expo Anal 

Environ Epidemiol 2002; 12;3 13-I 8. 

Am J Epidemiol 2004; 159:373-380 

from hL tpr; ' I I academic . oup. com/" :leI aJ;:-t icle "abst J:"act /l 59/ il/173/772 2 7 I Canccr. tnc i.denc<' -among- Pesticide-App: icators 
638 


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HHS Public Access 

Author manuscript 

Published in final edited fOrm as; 

/nt J Cancer. 2015 September l; 137(5): ll67-ll75. doi: I OJ0021ijc.29416. 

Use of acetochlor and cancer incidence in the Agricultural 

Health Study 

Catherine c. Lerro1·2 , Stella Koutros1, Gabriella Andreotti1, Cynthia J. Hlnes3, Aaron Blair1, 

Jay Lubin4, Xlaomei Ma2, Yawel Zhang2, and Laura E. Beane Freeman1 

1 Occupational and Environmental Epidemiology Branch, Division of Cancer Epidemiology and 

Genetics, National Cancer Institute, Bethesda, MD 

2Yale University School of Public Health, New Haven, CT 

3Division of Surveillance, Hazard Evaluations and Field Studies, National Institute for 

Occupational Safety and Heath, Cincinnati, OH 

48iostatistics Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute, 

Bethesda, MD 

Abstract 

Since its registration in 1994 acetochlor has become a commonly used herbicide in the US, yet no 

epidemiologic study has evaluated its carcinogenicity in humans. We evaluated use of acetochlor 

and cancer incidence among licensed pesticide applicators in the Agricultural Health Study. In 

telephone interviews adrninistcred 1999-2005, participants provided infonnation on acctochior 

usc, use of other pesticides, and additional potential confOunders. We used Poisson regression to 

estimate relative risks (RR) and 950;;) confidenc<..~ intervals {95%} CI) for cancers that occurred from 

the time of intervic:w through 2011 in Iowa and 2010 in North Carolina. Among 33,484 men, there 

were 4,026 applicators who used acetochlor and 3,234 incident cancers, with 304 acetochlorexposed cases. Increased risk of lung cancer was observed among acctochlor users (RR = l. 74: 

95% Cl: 1.07-2.84) compared to nonusers, and among individuals who reported using acctochlor/ 

atrazine produet mixtures {RR = 2.33; 95% CI: 1.30-4J 7), compared to nonusers of acetochlor. 

Colorectal cancer risk \Vas significantly elevated among the highcsj category of acetochlor users 

(RR L 75; 95% CJ: L08-2JB) compared to n~vcr users. Additionally, borderline significantly 

increased risk of melanoma (RR = 1.61; 9S% CI: 0.98-2.66) and pancreatic cancer (RR = 2.36; 

95% CI: 0.9R-5.65) were observed among acetochlor users. The associations bel ween acctochlor 

usc and lung cancer, wlorcctal cancer, melanoma. and pancreatic cancer arc suggestive, however 

the lack of exposure-response trends, small number of exposed cases, and relatively short time 

between acctochlor usc and cancer development prohibit definitive conclusions. 

li!rrncc!il)nai!.nih.gov. 

DISClAIMER 

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Keywords 

Acetochlor~ Agricultural Health Study; Pesticides; Cancer 

INTRODUCTION 

Acctochlor is a broad leaf herbicide and a member of the chloracetanilidc class 1

, which also 

includes alachJor, hutachlor, propachlor, and metolachlor. 1

· 2 In 1994, the US Environmental 

Protection Agency (EPA) approved acctochlor for use on corn. with continued registration 

dependent upon a reduction in the use of several other corn herbicides of known health 

concern, including alachlor, metolachlor, atrazine, 2.4~dichlorophenoxyacctic acid (2,4-D), 

butylate, and S-Ethyl dipropylthiocarbamatc (EPTC).3 Re-registration was not contingent 

upon reduction of usc for any particular herbicide, but rather an overall reduction in the use 

of these six herhicides.3 EPA re-affirmed acctochlor registration for use on field com and 

popcorn in 20064 Over 32 million pounds of acetochlor were applied during 1997-2001 on 

approximately 25% of com crops in the US; 5 similar amounts continue to be applied in 

recent years. 6 

The EPA considers acetochlor to have "suggestive evidence of carcinogenic potential" based 

on increased incidence of certain tumors in laboratory animals; 7 other agencies have not 

reviewed the carcinogenicity of this chemical. Acetochlor is not considered mutagenic or 

genotoxic at relevant doses, 8 however, evidence suggests potential for acetochlor-induced 

chromosomal aberration at cytotoxic doses. 1 In animal studies, lung tumors and histiocytic 

sarcomas have been reported in mice, while nasal olfactory tumors and thyroid follicular cell 

tumors have been reported in Sprague-Dawley rats. I Llver adenomas and carcinomas, renal 

adenomas and sarcomas, and benign ovarian tumors have been reported in rats and mice, 

however, generally only at excessively toxic doses or demonstrated weak associations with 

acetochlor exposure. 1 Bioassays of other chloroacetanilide herbicides have overlapping but 

not identical tumor profilcs. 1 

Epidemiologic research examining the relationship between acetochlor exposure and noncancer human health outcomes is limited. Acetochlor levels in umbilical cord blood of fulltenn infants were associated with risk of low birth weight in a pilot study from a Chinese 

birth cohort.9 Conversely, acetochlor levels in maternal urine during pregnancy were not 

associated with any adverse birth outcomes in a French birth cohort.IO A study of various 

pesticides found an inverse association between acetochlor exposure and semen quality. 

although this relationship was non-significant after excluding men with other risk factors for 

reduced semen quality. 11 Though there have been no epidemiologic studies ofacetochlor 

and cancer risk to date, studies have evaluated other chloroacetanilide chemicals. Previous 

findings from the Agricultural Health Study (AHS) noted associations between alachlor 

exposure and lymphohcmatopoietic cancers, 12 and between metolachor exposure and lung 

canccr. 13• 14 

Because of the limited information on cancer risk with acctochlor exposure, we examined 

occupational exposure to acetochlor and subsequent cancer outcomes among pesticide 

applicators in the Agricultural Health Study (AHS). 

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MATERIALS & METHODS 

Study Population 

The AHS cohort has been described elsewhere in detaiL 15 Briefly, the AHS is a prospective 

cohort that includes 57,310 licensed pesticide applicators enrolled during 1993-1997 in Iowa 

and North Carolina. A follow-up interview was conducted during 1999-2003 for private 

applicators and 2003-2005 for commercial applicators, with 36,342 total respondents. 

Incident cancer cases were obtained via linkage with Iowa and North Carolina state cancer 

registries. Cancer site was classified according to the International Classification of Diseases 

for Oncology (third revision). 16 Due to its recent introduction in 1994, we ascertained 

acetochlor usc only at follow-up interview. Thus, we analyzed first primary cancers 

diagnosed from the date of follow-up interview through last date of study follow-up 

(December 31,2011 for Iowa, December 3 I, 2010 for North Carolina). The study protocol 

was approved by the institutional review boards of the National Institutes of Health, 

University of Iowa, and all other contractors in compliance with applicable requirements of 

the US. 

Exposure Assessment 

Computer assisted telephone interviews assessed use of acctochlor and other factors, the 

texts of which arc available at http:!/aghcalth.nih.gov/background/qucstionnaircs.html. 

Participants were asked to list all pesticides used on each crop during the last year they 

fanned. Additionally, they were probed to specify if they personally mixed, handled, or 

applied each pesticide, and how many days per year they applied the pesticide. Where trade 

names were reported, individual active ingredients were abstracted from the product trade 

names. 

Whether or not an applicator reported any application ofacetochlor (yes/no) was examined 

in order to broadly classify personal use. Total years of acetochlor use for each applicator 

was assumed to be number of years between the year the applicator last fam1ed (follow-up 

interview reference year) and the enrollment year; we used 1994 (year of aeetochlor 

registration) for applicators enrolled prior to this date. The number of lifetime days of 

acetochlor use was calculated by multiplying the number of days per year using acetochlor 

by total years of use. lntensity-wcighted lifetime exposure days were computed by 

multiplying an intensity weighting factor by lifetime exposure days. The intensity weighting 

factor is a function of pesticide handling practices and personal protective equipment used. 17 

Exposure days and intensity-weighted exposure days were classified as low (less than the 

median among all exposed cancer cases) or high (greater than or equal to the median among 

all exposed cancer cases). Additionally, because acctochlor is frequently applied as a 

mixture with atrazinc (53% ofacctochlor applicators reported use of such a mixture), we 

classified usc as 1) never applied acetochlor or atrazine, 2) applied acetochlor but not 

atrazine, 3) applied atrazine but not acetochlor, or4) applied both acetochlor and atrazine. 

Application of both acetochlor and atrazinc were further separated into those who reported 

use of acetochlor/atrazine mixtures (based on trade names of product mixtures including 

acetochlor and atrazine) and those who reported use of acctochlor and atrazine separately. 

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Statistical Analysis 

RESULTS 

Analyses were limited to individuals who responded to the follow-up interview (n = 36,342), 

and we further restricted to male pesticide applicators due to the small number of female 

applicators (n 1006) and few exposed cancer cases (n = 4). We excluded men with cancer 

diagnoses prior to completion of the follow-up interview (n =- 1675) and men with missing 

or zero person-years of follow-up (n = 177), leaving 33,484 applicators available for 

analysis. Analyses examining lifetime days and intensity-weighted days of acetochlor use 

further excluded those missing days of usc (n ~ 456) or intensity (n""" 11), leaving 33,028 

and 33,017 applicators, respectively. 

We report results for all cancer sites with at least 15 exposed cases for days and intensityweighted days of use, and results for ever use for sites with more than five exposed cases. 

Colon and rectal tumors were combined as were lymphohematopoictic cancers. Aggressive 

prostate cancer, as defined by Koutros et al, was examined separately. 18 Relative risks (RR) 

and 95% confidence intervals (Cis) were estimated using Poisson regression in SAS version 

9.3 (SAS Institute, Inc., Cary, NC). Subjects contributed person-time from date offollow-up 

interview through date of first cancer diagnosis, date moved out of state, date of death, or 

last follow-up, whichever occurred first. 

All models were adjusted for potential confounders including age at follow-up interview 

(continuous), state of residence (Iowa or North Carolina), applicator type (private or 

commercial), duration of cigarette smoking as reported at enrollment (never, <I 0 years, 

10-19 years, 20-29 years, 30• years, missing), race (white, other, missing), alcohol usc 

(yes/no in preceding 12 months, missing), educational attainment (less than a high school 

degree, high school degree, more than a high school degree, missing), use of an enclosed 

tractor cab (yes, no, missing), and family history of cancer in first degree relatives (yes, no, 

missing; specific cancer site where available). We also adjusted for ever-use of pesticides 

most highly associated with acetochlor use (lifetime use: imazethapyr, dicamha, atrazine, 

EPTC, eyanazinc, pcndimethalin, trifluralin; follow-up only: flumetsulam, clopyra1id, 

isoxaflutolc), pesticides mentioned in the acetochlor EPA registration (alachlor, metolachlor, 

atrazinc, EPTC, 2,4-D, butylate), and pesticides previously found to be associated with 

specific cancer outcomes in the AHS. 19 Tests for trend used the midpoint of each exposure 

category treated as a continuous variable, Sensitivity analyses were conducted in which the 

cohort was restricted to cases diagnosed more than two years after completion of foliow~up 

interview. AU tests were two-sided with et 0.05. Data in this analysis arc based on the 

AHS data releases P2REL201209.00 and PIREL201209.00. 

Table 1 displays selected demographic, behavioral, health, and farming characteristics of the 

cohort, stratified by acctochlor use. Acetochlor was used almost exclusively by applicators 

in Iowa {99%). A larger proportion of commercial applicators used acetochlor compared to 

private applie<1tors (28.9% and 9.3%, respectively). Applicators who used acetochlor were 

more likely to be younger, more educated, and white compared to non-users. Applicators in 

Iowa similarly tend to be younger, more educated, and white compared to applicators in 

North Carolina, so these differences may be regional and not directly related to acetochlor 

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use. Additionally, acetochlor users were more likely than non-users to be never-smokers and 

ever-drinkers in the last 12 months, have no family history of cancer, and report that the 

tractor regularly used to apply pesticides had an enclosed cab. 

We evaluated the use of acctochlor in association with a variety of cancer sites controlling 

the covariates described above (Table 2). We observed an association with ever-use of 

acctochlor and increased risk of lung cancer (RR ~ 1.74; 95% CJ: 1.07-2.84), melanoma 

(RR ~ 1.61; 95% Cl: 0.98-2.66), and pancreatic cancer (RR ~ 2.36; 95% Cl: 0.98-5.65), 

although the associations for melanoma and pancreatic cancer were of borderline statistical 

significance. 

Compared to never use of acctochlor, low use of acetochlor, as measured by lifetime days 

used, was associated with a decreased risk of colorcctal cancer (RR = 0.31; 95% CI: 

0.11-0.83) while high usc was associated with an increased risk of colorectal cancer (RR = 

1.75; 95% CI: 1.08-2.83), with a borderline significant exposure-response trend (p-trcnd = 

0.07, Table 3). Results were similar for colorectal cancer risk and lifetime intensityweighted days of acetochlor usc. Low use of acetochlor, as measured by lifetime days used, 

was associated with an increased risk of lung cancer (RR ·"' 2.64; 95% Cl; 1.47-4.74) 

compared to never usc; no association was seen for high use and no exposure-response trend 

was observed {p-trend = 036). Similarly, low usc of acetochlor, as measured by lifetime 

intensity-weighted days used. was associated with an increased risk of lung cancer (RR 

2.26; 95% Cl: 1.24-4.14,p-trend ~ 0.16). High use ofacetochlor, as measured by lifetime 

days used, was associated with borderline increased risk of melanoma (RR 1.78; 95% CI: 

0.90-3.52, p-trcnd = 0.08) compared to never use. However, when measured using lifetime 

intensity-weighted days used, low acetochlor use was associated with borderline increased 

risk of melanoma (RR ~ 1.79; 95% Cl: 0.93-3.45,p-trend ~ 0.29). 

Over 80% of acetochlor users also reported use of atrazine at follow-up interview (Table l ); 

53% of applicators reporting ever use of acctochlor report using it in a product also 

containing atrazine. We found that applicators using both atrazine and acctochlor were at 

increased risk of lung cancer (RR""' 2.01; 95% CI: 1.17-3.46) compared to those with no use 

of either (Table 4). This association was similarly strong for persons using acetochlor/ 

atrazine product mixtures {RR = 2.33; 95% CI: 1 .30-4.17), compared to use of neither 

atrazinc nor acetochlor. Among those exposed to acctochlor as a mixture only, we saw 

elevated risks among both low (RR- 2.71; 95% CJ: 1.14-5. 78) and high (RR ·c 1.96; 95% 

Cl: 0. 75-5.11) categories of intensity-weighted days of exposure (results not shown). We 

also obsel\led a borderline significant excess risk of pancreatic cancer among users of 

atrazine/acetoch1or product mixtures (RR ~ 2.62; 95% Cl: 0.95-7.20). 

The findings for lung cancer, colorectal cancer, melanoma, and pancreatic cancer were 

similar in magnitude and direction after restricting the study population to those diagnosed 

with cancer at least two years after completion of the follow~up intel\liew. though the risk 

estimates for ever usc of lung and pancreatic cancer no longer reached statistical 

significance. We limited lung and pancreatic cancer analyses to never smokers to examine 

the results independent of smoking status. The results were in a similar direction and 

magnitude for low acctochlor exposure (days of use) and risk of lung cancer (RR = 3.30; 

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95% CI: 0.89-12.27), though the association was only borderline statistically significant. It 

is possible that the small number of exposed cases (n""' 3) caused the estimates to be 

unstable. We saw a stronger association for ever use of acctochlor and risk of pancreatic 

cancer when restricting to never smokers {RR ~ 5.61; 95% CI: 1.58-19.97). We also 

restricted our analyses to Iowa applicators, as the majority of acetochlor was applied there 

(98.8%); the results were overall very similar. Approximately half of our study population 

had complete infonnation regarding potential confounders for colorectal cancer (physical 

activity, fruit and vegetable consumption) and melanoma (sun sensitivity and sun 

protection). When we limited our analyses to these men, the relationship for high days of 

acetochlor use and colorectal cancer was similar in magnitude and direction (RR = 1.71; 

95% Cl: 0.88-3.33) after controlling for physical activity and dietary factors, and the 

relationship between ever use of acetochlor and melanoma risk was strengthened (RR255; 95% Cl: 1.45-4.48) after controlling for sun sensitivity and exposure factors. We also 

examined days and intensity-weighted days of acetochlor usc per year, classified as high or 

low based on the median among cancer cases, in order to determine if number of years 

between enrollment and follow-up was skewing our results. The results were consistent with 

findings for days and intensity-weighted days, and we additionally observed a significant 

exposure-response trend for intensity-weighted days per year of acctochlor use and lung 

cancer risk (p-trend ~ 0.05). 

DISCUSSION 

In this analysis of reported use ofacetochlor among AHS applicators, we found elevated risk 

for several cancer sites. To our knowledge, this is the first epidemiologic study attempting to 

evaluate cancer risk from occupational use of acctochlor. Specifically, we observed an 

increased risk of colorectal cancer among pesticide applicators with high lifetime use of 

acetochlor, and increased risk of lung cancer among ever users and low lifetime users of 

acetochlor. Additionally, ever use and increasing days of acetochlor use were associated 

with borderHne significantly increased risk of melanoma. Though the number of exposed 

cases was small, there was a borderline significant increased risk of pancreatic cancer 

among ever users of acctoch1or. 

The finding that use of acctochlor is associated with increased risk of lung cancer is 

complicated because it was observed among those with below median use, but not among 

those with higher exposure. However, this finding was robust in sensitivity analyses 

restricting the cohort to persons diagnosed two or five years after interview. This suggests 

that reporting of acetochlor use was not likely to be influenced by early disease. A previous 

AHS analysis found that high usc of mctolachlor, another chJoracctanilide herbicide, was 

associated with an increast!d risk oflung cancer. 14 The observed association in our study did 

not appear to be related to previous mctolachlor use, as there was very little correlation 

between metolachlor and acctochlor usc (p= 0.11). Concerned about the possibility of 

residual confounding, we adjusted for smoking using several mctrics, including duration 

(years smoked), total cigarette exposure (pack-years), and current/fonncr/nevcr smoking 

status; all produced similar results and duration was chosen based on mode) fit. We saw 

results of a similar direction and magnitude for low acetochlor exposure and risk of lung 

cancer when we restricted our sample to never smokers. Because we did not see an excess of 

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lung cancer among the more highly exposed individuals and there was no significant 

exposure-response trend, the association may be spurious. Though we were underpowered to 

do so, future studies should attempt to examine lung cancer risk by histologic subtype; we 

noted slight differences in lung cancer histologic subtype by acetochlor exposure in 

descriptive analyses. 

Colorectal cancer is not often associated with occupational exposures;20 however, we 

observed an increased risk between reported acetochlor use and risk of colo rectal cancer, 

with some indication of an exposure-response trend. In the AHS, several pesticides have 

been associated with colon and rectal cancers; aldicarb, dicamba, EPTC, imazethapyr, and 

trifluralin were associated with colon cancer, and chlordane, chlorpyrifos, pendimethalin, 

and toxaphene were associated with rectal cancer. 19 A small study of manufacturing 

workers exposed to alachlor, a chemical stntcturally related to acetochlor, found elevated 

risks of colorectal cancer. 2 1 A limitation in our study is that while we could control for body 

mass index, an established risk factor for colorectal cancer,22 we were not able to control for 

other known risk factors such as dietary habits or physical activity,20 which were only 

collected for a portion of the cohort. When restricted to individuals who provided 

information on leisure time physical activity and average fruit and vegetable consumption, 

our results remained relatively unchanged. 

We observed an association between melanoma and ever usc of acetochlor, though the 

exposure-response relationship was not consistent for days and intensity-weighted days of 

usc. The relationship between pesticides and melanoma is complicated by other 

occupational exposures, particularly extended exposure to natural ultraviolet radiation, 23 

however several pesticides have been associated with melanoma in previous AHS 

analyses. 24• 25 Sun sensitivity and exposure characteristics were only available for about half 

of our cohort; however when we limited our analyses to men with valid response and 

controlled for these factors, the relationship between ever usc of acetochlor and melanoma 

risk wa<> strengthened. 

Occupationally, pancreatic cancer has been associated with chlorinated hydrocarbon 

soJvents,26 though findings for chlorinated pesticides and pancreatic cancer have been less 

clear.27-30 In the AHS, EPTC and pcndimethalin were associated with increased risk of 

pancreatic cancer, possibly via the formation ofN-nitroso-compounds.31 Smoking, an 

established risk factor for pancreatic cancer, was controlled for in our analyses and we 

observed a significantly increased risk of pancreatic cancer among never smokers. While we 

did not present the results due to small number of exposed cases, we did see a significant 

exposure-response trend for intensity-weighted days of acetochlor use and pancreatic cancer 

(p-trend = 0.01). Future studies should evaluate these findings. 

We evaluated atrazine and acetochlor product mixtures because these active ingredients arc 

often applied as a mixture in our cohort. Previous studies in the AHS have not been able to 

explicitly examine product mixtures because of how pesticide usc was assessed at 

cnrollment. 14· 

32· 33 At follow-up interview, participants self-reported specific pesticide 

product names, and based on this information we determined if acetochior was being applied 

alone or as a mixture with atrazine. These analyses did not account for applicators who 

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mixed individual ingredients or products on their own (as opposed to using pre-mixed 

formulations); this information was not collected. Little is known about the toxicology and 

potential carcinogenicity of pesticide mixtures. Epidemiologic studies usually examine 

pesticides either independently, or more often by chemical class. Findings here suggest that 

future epidemiologic studies should consider the effects of pesticide mixtures, particularly 

acetochlor and atrazinc, and future toxicological studies should attempt to understand 

whether exposure as a mixture influences genotoxicity and mutagenicity. 

Acetochlor, like most pesticides licensed for use today, does not appear to be mutagenic or 

gcnotoxic in laboratory studies. 1 Therefore, other mechanisms of carcinogenesis should be 

considered. Occupational use of other chloracetanilide herbicides alachlor and metolachlor 

was significantly associated with shortened telomere length in a recent AHS study, 34 

acetochlor was not examined. Telomere length has been implicated in cancer etiology.35 

Another proposed mechanism of carcinogenicity for chloracctanilide herbicides involves 

bioactivation through several steps to DNA-reactive metabolites (2-methy!-6-

ethylbenzoquinone imine for acctochlor and mctolachlor and 2,6-diethylbenzoquinone imine 

for alachlor). 7 These chloracetanilide metabolites, 2-methyl-6-ethylbenzoquinonc imine and 

2,6-dicthylbenzoquinone imine, may lead to formation of DNA adducts or single-strand 

DNA breaks.?· 36• 37 Studies suggest that triazine herbicides, such as atrazine, stimulate 

cytochrome P450 (CYP450) system activity38 Acetochlor is metabolized and potentially 

bioaetivated by members of the CYP450 family of enzymes, CYP2B6 and CYP34A, in the 

1iver.7 Thus, when atrazine and acetochlor are applied together, it is possible that there is 

increased acctochlor bioactivation as a result of atrazine-induced CYP450 activity. 

Our analysis is the first epidemiologic study to examine the effect of acetochlor on cancer 

outcomes in humans. Strengths include longitudinal study design with regular follow-up of 

participants for cancer and morta1ity outcomes, as well as detailed and validated selfreported pesticide exposure and intensity infom1ation. 39 An important limitation for our 

analysis was sample size; although AHS is a large cohort, only about 12% (n = 4026) of our 

sample reported any acetochlor use. Additionally because acetochlor was introduced after 

AHS enrollment and therefore assessed only in follow~up lnterviews, the fOllow-up period is 

shorter than analyses of other chemicals, and thus fewer cancer cases were accrued. Because 

acetochlor was registered for use relatively recently, the observed associations for acetochlor 

and solid tumors may be due to earlier exposures and reflect long latency periods for these 

cancers. However, we restricted our cohort to those diagnosed at least two and five years 

after the start date of the study, and did not see marked differences in the magnitude and 

direction of the effects for lung cancer, colorectal cancer, pancreatic cancer, and melanoma. 

Applicators in our cohort were typically applying other pesticides prior to acetochlor 

registration and concurrently at follow-up interview. We controi1ed for use of pesticides that 

were highly correlated with acetochlor, as well as herbicides that were specified in the 

acetochlor EPA registration, in order to minimize these possible sources of confounding. 

Due to limited numbers of cases, we were unable to evaluate rarer cancer sites, as well as 

histologic subtypes of more common cancers. Due to few exposed women, we were unable 

to evaluate cancer sites more common in temales such as breast or thyroid cancer. 

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In conclusion, we observed associations between acetochlor use and lung cancer, colorectai 

cancer, pancreatic cancer, and melanoma. However, due to minimal evidence for exposureresponse relationships, the observed associations could reflect chance findings. Findings 

regarding the carcinogenicity of acetochlor need further evaluation in populations with 

sufficient numbers of exposed subjects. Additionally, future studies should attempt to 

evaluate potential mechanisms of carcinogenesis for acctochlor and other chloroacetanilide 

herbicides by examining genetic markers of susceptibility, as well as markers of cellular and 

DNA damage. 

ACKNOWLEDGEMENTS 

This work was supported by the intramural research program of the National Institutes of Health, the National 

Cancer Instirute (ZO!-CPO!Oll9), and the National InstiruteofEnvironmcntal Health Sciences (ZOI·ES049030). 

Abbreviations 

EPA Environmental Protection Agency 

2,4-D 2,4-dichlorophcnoxyacetic acid 

EPTC S-Ethyl dipropylthiocarbamate 

AHS Agricultural Health Study 

DNA Deoxyribonucleic acid 

CYP450 Cytochrome P450 

NHL Non-Hodgkin Lymphoma 

BMI Body Mass Index 

REFERENCES 

1. Evaluation of the Carcinogenic Potential of Acetochlor (Fifth Assessment) (121601). Environmental 

Protection Agency, Cancer Assessment Review Committee, Health Effects Division, Office of 

Pesticide Programs; 2007. p. l-66. 

2. Green T, LeeR, Moore RB, Ashby I, Willis GA, Lund VJ. Clapp MJ. Acetochlor-induced rat nasal 

tumors: further studies on the mode of action and relevance to humans. Regul Toxicol Phannacol. 

2000; 32:127-33. [PubMed: 11029275] 

3. Acetochlor (EPA-HQ-OPP-2007-0725-0002). Environmental Protection Agency; 2007. 

4. Acetochlor; Tolerance Reassessment Decision (RPA-HQ-OPP-2005-0227). Vol. 71. Environmental 

Protection Agency; 2006. p. 15730-1. 

5. Usage Rep on in Suppon of Registration for the Herbicide Acetochlor ( 12160 I). Environmental 

Protection Agency, Office of Prevention, Pesticides, and Toxic Substances; Washington, DC: 2004. 

6. Pesticide Industry Sales and Usage: 2006 and 2007. Market Estimates Office of Pesticide Programs, 

US Environmental Protection Agency; Washington, DC: 2011. 

7. Coleman S, Linderman R, Hodgson E, Rose RL. Comparative metabolism of chloroacetamide 

herbicides and selected metabolites in human and rat liver microsomes. Environ Health Perspect. 

2000; 108:1151--7. (PubMed: 11133395] 

8. Ashby J, Kier L, Wilson AG, Green T, Lefevre PA, Tinwell H, Willis GA, Heydens WF, Clapp MJ. 

Evaluation of the potential carcinogenicity and genetic toxicity to humans of the herbicide 

acetochlor.l!um Exp Toxicol. 1996; 15:702-35. [PubMed: 8880207] 

Int JCanca. Author manuscript; available in PMC 2016 September 01. 
647 


27172.602

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9. Wickerham EL, LozoffB, Shao J, Kaciroti N, Xia Y, Meeker JD. Reduced birth weight in relation 

to pesticide mixtures detected in cord blood offull-tenn infants. Environ Int. 2012; 47:80-5. 

[PubMed; 22796478] 

10. Chevrier C, Limon G, Monfort C, Rouget F, Garlantezec R, Petit C, Durand G, Cordier S. Urinary 

biomarkers of prenatal atrazine exposure and adverse birth outcomes in the PELAGIE birth cohort 

Environ Health Perspect. 2011; 119:1034·41. [PubMed: 21367690] 

11. Swan SH, Kruse RL, Liu F, Barr DB, Drobnis EZ, Redmon JB, Wang C, Brazil C, Overstreet JW. 

Semen quality in relation to biomarkers of pesticide exposure. Environ Health Perspect. 2003; 

Ill :1478-84. [PubMed: 12948887] 

12. Lee WJ, Hoppin JA, Blair A, Lubin JH, Dosemeci M, Sandler DP, Alavanja MC. Cancer incidence 

among pesticide applicators exposed to alach!or in the Agricultural Health Study. Am 1 Epidemiol. 

2004; 159:373~·80. (PubMed; 14769641] 

13, Rusiecki JA, Hou L, Lee WJ, Blair A, Dosemeci M, Lubin JH, Bonner M, Samanic C, Hoppin 1A, 

Sandler DP, Alavanja MC Cancer incidence among pesticide applicators exposed to metolachlor 

in the Agricultural Health Study.lnt J Cancer. 2006; 118:3118-23. [PubMed: 16425265] 

14. Alavanja MC, Dosemeci M, Samanic C, Lubin J, Lynch CF, Knott C, Barker J, Hoppin 1A, 

Sandler DP, Coble J, Thomas K, Blair A. Pesticides and lung cancer risk in the agricultural health 

study cohort. Am J EpidemioL 2004; 160:876 85. [PubMcd; 15496540] 

15. Alavanja MC, Sandler DP, McMaster SB, Zahm SH, McDonnell CJ, Lynch CF, Pennybacker M, 

Rothman N, Dosemeci M, Bond AE, Blair A. The Agricultural Health Study. Environ Health 

Perspect 1996; I 04:362 -9. [PubMed; 8732939] 

16. Fritz, AG. International Classification of Diseases for Oncology: ICD-0. World Health 

Organization; 2000. 

17. Coble J, Thomas KW, Hines CJ, Hoppin JA, Dosemcci M, Curwin B, Lubin 111, Beane Freeman 

LE, Blair A. Sandler DP, Alavanja MC An updated algorithm for estimation of pesticide exposure 

intensity in the agriculrural health study. Int J Environ Res Pubhc Health. 2011; 8:4608"·22. 

[PubMed; 22408592] 

18. Koutros S, Beane Freeman LE, Lubin JH, Heltshe SL, Andreotti G, Barry KH, DellaValle CT, 

Hoppin JA, Sandler DP, Lynch CF, Blair A, Alavanja MC Risk of total and aggressive prostate 

cancer and pesticide use in the Agricultural Health Study. Am 1 Epidemiol. 2013; 177:59~ 74. 

[PubMed: 23171882] 

19. Weichenthal S, Moase C, Chan P. A review of pesticide exposure and cancer incidence in the 

Agriculrural Health Study cohort. Environ Health Perspect. 201 0; 118: 1117~25. [PubMed: 

20444670] 

20. Schottenfeld, D.; Fraumeni, JF. Cancer Epidemiology and Prevention. Oxford University Press; 

USA: 2006. 

21. Acquavella JF, Delzell E, Cheng 11, Lynch CF, Johnson G. Mortality and cancer incidence among 

alachlor manufacturing workers 1968-99. Occup En"Viron Med. 2004; 61:680-5. [PubMed: 

15258274] 

22. Siegel R, Ma J, Zou Z, Jemal A. Cancer statistics, 2014. CA: A Cancer Journal for Clinicians. 

2014; 64:9-29. [PubMed; 24399786] 

23. MacKie RM, Hauschild A, Eggermont AM. Epidemiology of invasive cutaneous melanoma. 

Annals of oncology: official journal of the European Society for Medical Oncology I ESMO. 

2009; 20(Suppl6):vil-7. [PubMed: 19617292] 

24. Dennis LK, Lynch CF, Sandler DP, Alavanja MC. Pesticide use and cutaneous melanoma in 

pesticide applicators in the agricultural heath study. Environ Health Perspect. 2010; 118:812-7. 

[PubMed: 2016400 I] 

25. Purdue MP, Hoppin JA, Blair A, Dosemeci M, Alavanja MC. Occupational exposure to 

organochlorine insecticides and cancer incidence in the Agriculturalllealth Study. Int 1 Cancer. 

2007; 120:642-9. [PubMed: 17096337] 

26. Ojajarvi A, Partanen T, Ahlborn A, Boffetta P, Hakulinen T, 1ourenkova N, Kauppinen T, 

Kogevinas M, Vainio H, Weiderpass E, Wesseling C. Risk of pancreatic cancer in workers 

exposed to chlorinated hydrocarbon solvents and related compounds: a meta-analysis. Am 1 

Epidemiol. 2001; 153:841-50. [PubMed: 11323314] 

Jnt J Cancer. Author manuscript; available in PMC 2016 September 0!. 
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27, Ji BT, Silverman DT, Stewart PA, Blair A, Swanson GM, Baris D, Greenberg RS, Hayes RB, 

Brown LM, Lillemoe KD, Schoenberg JB, Pattern LM, et at Occupational exposure to pesticides 

and pancreatic cancer. American journal of industrial medicine. 2001; 39:92-9. (PubMcd: 

11148019] 

28. Fryzek JP, Gam brant DH, Harlow SD, Severson RK, Gillespie 8\V, Schenk M, Schottenfeld D. A 

casc~control study of self-reported exposures to pesticides and pancreas cancer in southeastern 

Michigan.lnt J Cancer. 1997; 72:62-7. [PubMed: 92!2224] 

29. Garnbrant DH, Held J, Langholz B, Peters JM, Mack TM. DDT and related compounds and risk of 

pancreatic cancer. Journal of the National Cancer Institute, 1992~ 84:764 71. [PubMed: 1573662) 

30. Hoppin JA, Tolbert PE, Holly EA, Brock JW, Karrick SA, Altshul LM, Zhang RH, Bracci PM, 

Burse VW, Needham LL. Pancreatic cancer and serum organochlorine levels. Cancer Epidemiol 

Biomarkers Prev. 2000; 9:199-205. [PubMed: !0698482] 

3L Andreotti G, Freeman LE, Hou L, Coble J, Rusiecki J, Hoppin JA, Silverman DT, Alavanja MC. 

Agricultural pesticide use and pancreatic cancer risk in the Agricultural Health Study Cohort. Int J 

Cancer. 2009; 124:2495-500. [PubMed: !9142867] 

32. Freeman LE, Rusiecki JA, Hoppin JA, Lubin Jll, Koutros S, Andreotti G, Zahm SH, Hines CJ, 

Coble JB, Barone-Adesi F, Sloan J, Sandler DP, et aL Atrazine and cancer incidence among 

pesticide applicators in the agricultural health study (1994-2007). Environ Health Perspect 2011; 

119:1253-9. [PubMed: 21622085] 

33. Rusiecki JA, DeRoos A, Lee WJ, Dosemeci M, Lubin III, Hoppin JA, Blair A, Alavanja MC. 

Cancer incidence among pesticide applicators exposed to atrazine in the Agricultural Health 

Study. Journal of the National Cancer Institute. 2004; 96: 1375~82. [PubMed: 15367570] 

34. Hou L, Andreotti G, Baccarelli AA, SavageS, Hoppin JA, Sandler DP, Barker J, Zhu ZZ, Hoxha 

M, Dioni L, Zhang X, Koutros S, et aL Lifetime Pesticide Use and Telomere Shortening among 

Male Pesticide Applicators in the Agricultural Health Srudy. Environ Health Perspcct. 2013; 

121:919--24. [PubMed: 23774483] 

35. Ma H, Zhou Z, Wei S, Liu Z, Pooley KA, Dunning AM, Svenson U, Roos G, Hosgood HD 3rd, 

Shen M, Wei Q. Shortened telomere length is associated with increased risk of cancer: a metaanalysis. PLoS One. 2011; 6:e20466. [PubMed: 21695195] 

36. Bonfanti M, Taverna P, Chiappetta L, Villa P, D'Inca!ci M, Bagnati R, Fanelli R. DNA damage 

induced by alachlor after in vitro activation by rat hepatocytes. Toxicology. 1992; 72:207, 19. 

[PubMed: 1566280] 

37, Brown MA, Kinunel EC, Casida JE. DNA adduct formation by alachlor metabolites. Life sciences. 

1988; 43:2087 94. [PubMed: 3210901] 

38. Hernandez AF, Parron T, Tsatsakis AM, Requena M, Alarcon R, Lopez-Guamido 0. Toxic effects 

of pesticide mixtures at a molecular level: their relevance to human health. Toxicology. 2013; 

307:136 45. [PubMed: 22728724] 

39. Thomas KW, Dosemeci M, Coble JB, Hoppin JA, Sheldon LS, Chapa G, Croghan CW, Jones PA, 

Knott CE, Lynch CF, Sandler DP, Blair AE, et al. Assessment of a pesticide exposure intensity 

algorithm in the agricultural health study. J Expo Sci Environ EpidemioL 2010; 20:559-69. 

[PubMcdo 19888312] 

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Novelty and Impact 

This study is the first to examine the relationship between occupational exposure to 

acetochlor, a commonly used herbicide registered for use on com, and human cancer risk 

in a large prospective cohort. Acetochlor use was associated with increased risk of lung 

cancer, colorectal cancer, pancreatic cancer, and melanoma. Use of mixtures of 

acetochlor and atrazine, another widely used herbicide often applied concurrently with 

acetochlor, was associated with increased risk of lung cancer. 

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Table 1 

Selected characteristics of AHS pesticide applicators I who completed follow-up questionnaire (n~33,017), :t> 

c stratified by lifetime intensity-weighted days ofaectochlor use (none, low, high)2 

:T 

Q 

:s: Acetocbloruse 

Q) Tobl Never Low Use High Use p-valul ::J 

c ~=33,017 N--29,458 ~=1,621 N-4,938 

en NC'f.,) N(%) N(%) N(%) 

Q 

~ State 

Iowa 21810(66.06) 18297(62.11) 1601 {98.77) 1912(98.66) p < 0.0001 

North Carolina 11207(33.94) 11161 (37.89) 20 (1.23) 26(1.34) 

Type of applicator 

Commercial 2527(7.65) 1797(6.10) 141(8.70) 589(30.39) p<O.OOOl 

Private 30490 (92.35) 27661 (93.9) 1480(91.30} 1349(69.61) 

:t> Age at follow~up 

c Quarttle 1: <43.4 8319(25.20) 7058(23.96) 543 (33.50) 718 (37.05) p < 0.0001 :T 

Q Quarttle2: 43.4-51.2 8260(25.02) 7234 (24.56) 430(26.53) 596(30.75) 

:s: Quartile3:51.3-61.4 8227(24.92) 7431 (25.23) 362(22.33) 434 (22.39) 

Q) 

::J Quartile4:~61.5 8211 (24.87) 7735 (26.26) 286{17.64) 190 (9.80) 

c 

en Educational Attainment 4 () 

::J. 

~ < High School 2624 (7.95) 2532(8.60) 46(2.84) 46(2.37) p<0.0001 

High School Graduate 14774(44.75) 13168(44.70) 734(45.2&) 872 (44.99) 

> High School 14383 (43.56) 12596(42.76) 813(50,15) 974(50.26) 

OtheriMissing 1236 (3.74) 1162(3.94) 28(1.73) 46(2.37) 

Race 

White 31685(95.97) 28166(95.61) 1602 (98.83) 1917(98.92) p<O.OOOl 

:t> 

c Non-white 728 (2.20) 718{2.44) 7(0.43) 3 (0.15) 

:T Other/Missing 604 (L83) 574(1.95) 12 (0.74} 18(0.93) 

Q Tobacco use 4 

:s: 

Q) :-.;ever Smoker 17302(52.40) 

::J 15069(51.15) 1015(62.62) 12!8 (62.85) p<O.OOOJ 

c 

en Former Smoker, -:::;10 yrs 4896(14,83} 4380(14.87) 255 (15.73) 261 (IJ.47) 

() Former Smoker, >10 yrs 4548(13.77) 4225 (14.34) 159(9.81) 164(8.46) 

-g- Current Smoker, ~10 yrs 917 (2.78) 813 (2.76) 41 (2.53} 63 (3.25) 

Current Smoker, > 10 yrs 3885(11.77) 3574(12.13) 114(7.03) 197(10.17) 

M!ssing 1469(4.45) 1397 (4.74) 37(2.28) 35(1.81) 

Alcohol consumption 

No 17702(53.61) !6291 (55.30) 71!(43.86) 700(36.12) p<O.OOOl 

y" 15025 (45.51) 12886(43.74) 905 (55.83) 1234(63.67) 

:t> Missing 290(0.88) 281 (0.95) 5 (0.31) 4 (0.21) c 

:T Family History of Cancer 4 

Q 

:s: No 17390(52.67) 15347(52.10) 876 (54.04) 1167 (60.22) p < 0.0001 

Q) y, 12971 (39.29) 11579(39.31) 678(4UB) 714(36,84) ::J 

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Total 

N=33,017 

N(%) 

M1ssmg 2656(8,04) 

IJse of Enclosed Cah 

>Jo 20063 (60.77) 

y" 12954 (39.23) 

Atrazineuse 

No 22579 (68.39) 

y" 10438 (3!.61} 

1 

Reported on follow-up questionnaire 

' 

Acetochloruse 

Never Low Use 

N=29.458 ~=1,621 

N(l'f,) N(%) 

2532(8.60) 67 (4.13) 

19048 (64.66) 434(26.77) 

10410(35.34) !187(73.23) 

21932(74.45} 329 (20.30} 

7526(25.55) 1292 (79.7) 

-Low: 72-879 intensity-weighted days, High: 880- 47520 intensity-weighted days 

3 Chi-square test for homogeneity 

4

Reported on enrollment questionnaire 

High Use p-value3 

~=1,938 

N(%) 

57 (2.94) 

581 (29.98) p <0.00()1 

!357(70.02) 

318(16.41) p < 0.0001 

!620(83.59) 

lnt J Cancer. Author manuscript; available in PMC 20!6 September 01. 

Page 14 
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Table 2 

Relative risks (RR) and 95% confidence intervals (95% CI/ for ever-use of acetochlor, relative to never-use, 

and risk for various cancers among AHS applicators (n=33,484). 

Nunupo•ed Nnpoocd RR(95%CI) 

All Sites 2930 304 !,06 (0.94-1.21) 

Bladder 167 15 1.08 (0.61-1.91} 

LymphohematopoietJc 293 23 0.77(0.49-1.20) 

Colon 206 21 1.07 (0.66-1.73) 

Colo rectal 300 31 1.03 (0.69-1.53) 

Esophagus 42 1.28 (0.47-3.44) 

Kidney 98 13 1.14 (0.61-2.ll} 

Leukemia 93 0.89{0A3-1.84) 

Lung 251 23 J.74(J.07-2.84)H 

Melanoma 124 23 1.61 (0.98-2.66)* 

NHL 249 18 0.70(0A3-l.l6) 

Pancreas 55 2.36 (0.98-5.65)* 

Prostate 1232 130 0.99 (0.82-1.20) 

Prostate, Aggressive 644 69 0.98 (0.75-!.28) 

Rectum 94 10 0.97 {0.48-1.95) 

Sigmficant at p<O.I; 

.. Significantatp<0.05 

1 Adjusted for age, race, state, applicator type, smoking, family history of cancer, alcohol consumption, BMI, use ofan enclosed cab, education, 

and correlated /associated pesticide use 

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Table 3 

)> Relative risks (RR) and 95% confidence intervals (95% Cl)1 by days (n~ 33,028) and intensity-weighted days 

s. (n= 33,0 17) of acetochlor use, compared to never-usc, for various cancers. ::T 

~ Acetocblor intensity-weighted 

s: Acetochlor days usl days use 3 

"' :J 

c N RR(95%CI) N RR(95%CI) 

"' {") All Sites Never 2930 1.00 (REF) 2930 l.OO(Rl:F) ::l. 

-s. Low 119 0.99(0.82-1.20) 127 1.00 {0.83-1.20) 

High 139 1.19(1.00-1.43)* 131 120(1.00-1.45}"' 

p-trend 0.07. o.o6* 

Bladder Never 167 l.OO(REF) 167 1.00 (REF) 

Low 1.11 (0.51-2.44) 0.91 (0.39-2.10) 

)> High 0.74 (0.26-2.09) 1.01 (0.40-257) 

c p-trend 0.63 0.98 

5' 

~ Lymphohcmatopoictic Never 293 LOO(REF} 293 1.00 (REF) 

s: Low 12 0.93 (0.51-1.68) 10 0.76(0.40-1.44) 

"' High 0.80(0.40-1.59) 11 1.02(0.55-1.91) :J 

c p-trend 0.51 0.91 "' {") 

::l. Colon Never 206 l.OO(REF) 206 1.00 (REF) 

-s. Low 0.46(0.17-L27) 0.44(0.16-1.20) 

High 12 1.56(0.&3-2.91) 12 1.67(0.90-3.11) 

p-trend 0.28 0.20 

Colorecta! Never 300 l.OO(REF) 300 1.00 (REF) 

Low 0.31 (0.11-0.83)** 0.51 (0.24-1.09)* 

)> High 21 1.75 (1.08-2.83)** 18 1.59(0.95-2.64). 

c 

5' p-trend om* 0.16 

~ Kidney Never 98 I.OO(REF) 98 1.00 (REF) 

s:: Low 0.81 (0.29-2.25) 0,57 (0.18-1.86) 

"' :J High 1.53(0.67-3.47) 1.87 (0.86-4.03) c 

"' p-trcnd 0.36 0.16 {") 

::l. 

-s. Lung Never 251 1.00 (REF) 251 1.00 (REF) 

Low 14 2.64 (1.47-4.74) ** 13 2.26 ( 1.24-4.14) *"' 

High 1.14 (0.51-2.57) 1.47 (0.68-3.16) 

p-trend 0.36 0.16 

Melanoma Never 124 1.00 (REF) 124 l.OO(REF) 

Low 1.41 {0.67-2.97) 11 1.79 (0.93-3.45)* 

)> 

c High 11 1.78 (0.9{1-3.52)* 1.38 (0.64-2.99) 

5' o.os* 0.29 ~ p-trcnd 

s:: NHL Never 249 1.00 (REF) 249 l.OO{REF) 

"' Low 11 1.01 (0.54-1.87) 10 0.89(0.47-1.71) :J 

c 

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Acetocblor dars usi Acetochlor intensity-weighted 

dal:S use 3 

N RR(95%CI) N RR(95%CI) 

High 0.50(0.20-1.25) 0.63 (0.28-1.46) 

p-trend 0.16 0.27 

Prostate Never 1232 l.OO(REF) 1232 1.00 (REF) 

Low 52 0.95 (0.72-1.27) 57 0.99(0.75-!.30) 

High 59 1.10(0.84-1.46) 54 1.08 (0.81-1.44) 

p-trend 0.54 0.63 

Never 644 l.OO(REF) 644 l.OO(REF) 

Prostate. Aggressive Low 27 0.92(0.62-1.36) 30 0.97 (0.67-1.42) 

High 33 1.20(0.83-1.74) 30 1.16(0.78-1.70) 

p-lrend 0.40 0.50 

Significant at p<O.l 

.. Significant at p<0.05 

1 Adjusted for age, race, state, applicator type, smokmg, family history of cancer, alcohol consumption, BMI, use of an enclosed cab, education, 

andcorrelated/associatedpesticideusc 

2

Low: 2-19 days, High: 20-1080 days 

3

Low: 72-879 intensity-weighted days, High: 880-47,520 intensity-weighted days 

lnt.! Cancer. Author manuscript; available in PMC 2016 September 01. 
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Table4 

Relative risk (RR) and 95% confidence intervals (95% CJ/ for ever applying acetochlor and atrazine alone or 

as a mixture, compared to never use, for selected cancers. 

A!! Sites 

Co!orcctal 

Lung 

Melanoma 

Neither acetochlor or atrazin~ 

Acetochlor 

Atrazine 

Both acetochlor and atrnzine 

Applied separately 

Apphed as a mh:ture 

Neither acetoch!or or atrazine 

Acetochlor 

Atrazine 

Dothacetochlorand atrnzine 

Applied separately 

App!iedasamixll.Jre 

~either acetochlor or atrazin~ 

Acetoch!or 

Atrazine 

Bothacetoch!orandatrazine 

Applied separately 

Applied as a mixture 

Neither acetochlor or atrazine 

Acetochlor 

Atrazine 

Bothacetochlorandatrnzine 

Applied separately 

N 

2282 

59 

648 

245 

83 

162 

240 

60 

25 

17 

204 

47 

19 

" 

89 

35 

17 

RR(95%CI) 

l.OO(RF.F) 

0.99(0.76-1.29) 

1.07 (0.97-!.17) 

1.12(0.97-1.29) 

1.20(0.95-1.50) 

1.08 (0.91-1.28) 

l.OO(REF) 

0.87(0.38-1.99) 

0.91(0.67-1.23) 

1.03 (0.66-L61) 

1.01 (0.49-2.11) 

1.04(0.62-1.75} 

LOO(REF) 

1.96{0.70-5.45) 

1.32(0.93-1.88) 

2.01 (L17-3.46)"'* 

1.29(0.45-3.68) 

2.33 (U0-4.17)** 

I.OO(REF) 

2.24 (0.94-5.33)* 

1.39(0.9!-2.14) 

1.75(0.97-3.!4)* 

1.87 (0.77-4.51) 

Appliedasamixture 11 1.69(0.86-3.34) 

Pancreas Neither acetochlor or atrazinc 49 1.00 (REF) 

Acetochlor 2.62 (0.6-11.44) 

Atradne 0.63 (0.26-1.55) 

. 

Bothacetochlorand atrazine 

Applied separately 

Applicdasamixture 

Significant at p<O.l; 

1.84 (0.67-5.08) 

2.62(0.95-7.20)* 

E" Significant at p<O.OS 

:f 1 

Adjusted for age, race, state, applicator type, smoking, family history of eaneer, alcohol consumption, BMI, use of an enclosed cab, education, Q .and correlated /associated pesticide use 

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-[ lnt JCancer. Author matluscript; available in PMC 2016 September 01. 
656 

Senator MERKLEY. Mr. Dourson, I understand you have been 

paid to assess the safety of both of these chemicals; therefore, your 

familiarity with them I anticipate to be significantly more. What 

organization paid you to assess the safety of these two chemicals? 

Just the name, please. 

Mr. DOURSON. Dow AgroSciences. And we also had Monsanto. I 

believe both of them contributed to a collaborative project that included a group of people, including government scientists, that 

helped with the assessment. 

Senator MERKLEY. Thank you. That is my understanding, those 

two companies. 

Mr. DOURSON. Right. 

Senator MERKLEY. Your organization ultimately recommended 

reference dose for the degradates or breakdown products that 

would translate to a safety level of 5,600 parts per billion. That is 

a significantly weaker standard than the standard set by the State 

of Wisconsin of 20 parts per billion, of Minnesota at 60 parts per 

billion. In fact, the safety standard proposed is 280 times weaker 

than standards set by Wisconsin and 70 times weaker than that of 

Minnesota. 

The same trend is true for acetochlor. Your standards were 15 

times weaker than standards set by Minnesota. This is a disturbing pattern for someone charged with representing the safety 

of our citizens from these chemicals. 

Mr. Chairman, I would like unanimous consent to submit for the 

record a letter from a wide range of worker advocacy organizations, 

including many farm worker advocacy organizations. 

Senator BARRASSO. Without objection. 

[The referenced information follows:] 

657 


27172.619

October 2, 2017 

The Honorable john Barrasso 

Chairman 

Committee on Environment and Public Works 

410 Dirksen Senate Office Building 

Washington, DC 20510 

Dear Senators: 

The Honorable Thomas R. Carper 

Ranking Member 

Committee on Environment and Public Works 

456 Dirksen Senate Office Building 

Washington, DC 20510 

We, the undersigned organizations, serve and represent farmworkers, rural, immigrant, indigenous and 

Latino communities at the local, state and national level. We write to you on behalf of over two million 

farmworkers in the United States and the Commonwealth of Puerto Rico. Agriculture is one of the most 

dangerous industries in the nation, with higher worker death rates than in the transportation, mining 

and construction industry sectors.l Daily exposure to a range of harmful agricultural chemicals is among 

one of the many hazards that farmworkers encounter on the job. Farmworkers urgently need and 

deserve the strongest safeguards to prevent illness, injuries, and fatalities, and to protect the healthy 

development of their children and families from toxic chemicals. As organizations that represent 

some of the workers and communities most exposed to toxic pesticides, we urge you to oppose 

the confirmation of Dr. Michael Dourson to head the Office of Chemical Safety and Pollution 

Prevention at the EPA. 

The impacts of occupational exposures to pesticides on men, women and children are a reality of 

everyday life that we see on a regular basis in the course of our work in and among the people in these 

communities. Farmworkers tell us about their experiences in the field - their health concerns for 

themselves and their children or symptoms they may be experiencing, such as headache, nausea, 

vomiting and dizziness. Most farmworkers do not have health insurance, so many of their symptoms go 

untreated. Sometimes these symptoms go away without treatment. Other times, the symptoms may lead 

to further health complications that impact the entire family, especially if a family member loses work 

and income due to an untreated illness. Long-term exposure can lead to debilitating chronic illnesses 

for an already disadvantaged community. 

Alarmingly, what we know about Dr. Dourson and his company, Toxicology Excellence for Risk 

Assessment (TERA), is that they have served as toxicologists-for-hire, paid by chemical companies and 

their trade associations to cast doubt on the science and to undermine health-protective standards for 

dozens of toxic chemicals, including the neurotoxic chemical chlorpyrifos. 2 

Chlorpyrifos is a widely used agricultural pesticide that poses serious risks to children, farmworkers, 

rural communities and all consumers. Prenatal exposures to chlorpyrifos have been linked to 

neurodevelopmental impairment in children and in many states, this chemical is most often identified 

as the culprit in acute pesticide poisoning incidents of workers and bystanders.' The health, safety and 

wellbeing of our members and our communities are directly threated by the continued use of this nerve 

agent pesticide, a chemical that EPA Administrator Scott Pruitt has refused to ban in our food. 

The nomination of Dr. Dourson to be in charge of chemical safety at the EPA is a threat to our 

nation's children, farmworkers and communities at the frontlines of exposure to chlorpyrifos: 

In 2006, Dr. Dourson and his colleagues at TERA published a paper, funded by Dow AgroSciences, 

making recommendations that would be far less protective than what EPA found was necessary 

to protect children its 2001 human health risk assessment.4 The 2006 paper relied heavily on 

the findings of another paper5 the authors published a year prior, also funded by Dow 

AgroSciences. 
658 


27172.620

Since Dr. Dourson's publications, several peer-reviewed studies have found harm to children's 

brains from much lower doses of chlorpyrifos than previously accounted for in EPA's risk 

assessments. 

Following these findings, in 2016, Dr. Dourson was among a group hired by the pesticide trade 

association Croplife America to present at a meeting of EPA's F!FRA Scientific Advisory Panel.6 

Dr. Dourson's group attempted to undercut one of the Columbia University studies that showed 

impaired mental development for children who were exposed to chlorpyrifos in the womb, and 

his group recommended that EPA do nothing to incorporate the findings ofneurodevelopmental 

harm to children in future risk assessments. 

Dr. Dourson's work on chlorpyrifos shows either a fundamental lack of understanding or a callous 

disregard for EPA's duty and mandate to protect children from pesticides. It is critically important to 

understand that this amounts to a national public health issue that affects us all. While we represent 

and defend farmworkers, the health of our nation's children is jeopardized by continued use of 

chlorpyrifos, due in part to EPA's own findings of unsafe levels on food and in drinking water. In 

addition, our country cannot afford the health consequences of the weakening of any protections of the 

public against exposure to toxic agricultural chemicals. By protecting farmworkers, we protect our food 

supply and, ultimately, we protect ourselves and the health of our children. 

We urge the Senate to wholeheartedly object to this unconscionable nomination. 

Respectfully, 

Alianza Nacional de Campesinas (National Alliance ofF arm worker Women) 

CRLA Foundation 

Earthjustice 

El Co mite de Apoyo a los Trabajadores Agricolas (The Farmworker Support Committee) 

Fair World Project 

Farmworker Association of Florida 

Farmworker Justice 

Farmworker Self-Help 

Food Chain Workers Alliance 

Labor Council for Latin American Advancement (LCLAA) 

League of United Latin American Citizens (LULAC) 

Mi Familia Vota 

Migrant Legal Aid 

Mixteco Indigena Community Organizing Project 

National Hispanic Medical Association (NHMA) 

New Mexico Center on Law and Poverty (NMCLP) 

New York Environmental Law and Justice Project (NYELJP) 

Northwest Forest Worker Center 

Organizaci6n en California de Lideres Campesinas, Inc. 

PCUN-Pineros y Campesinos Unidos del Noroeste (Northwest Treeplanters and Farm Workers United) 

United Automobile, Aerospace and Agricultural Implement Workers of America (UAW), International 

Union 

United Farm Workers (UFW) 

Warehouse Worker Resource Center 

Worker Justice Center of New York, Inc. (WJCNY) 

CC: Members of the Committee on Environment and Public Works 
659 


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1 American Federation of Labor and Congress of Industrial Organizations (AFL-CIO). [2017). Death on the job: The Toll 

of Neglect, 2017. (26'" edition). Retrieved from AFL-CIO website: https:j /aflcio.org/sitesjdefault/files/2017-

04/2 017Death-on-the-Job_O.pdf 

z See: Lerner, S., The Intercept, july 21, 2017 "Trump's EPA Chemical Safety Nominee Was In The 'Business Of Blessing' 

Pollution" and Adams, R. and Song, L., Inside Climate News, December 19, 2014 "One~Stap Science Shop Has Become a 

Favorite of Industry-and Texas" 3 Farmworker and Conservation Comments on Chlorpyrifos Revised Human Health Risk Assessment (Apr. 30, 2015), 

in EPA-HQ-OPP-2008-0850, available at 

http:/ /earthjustice.orgjsites/defaultjfilesjfilesjFarmworkerandConservationCommentsonChlorpyrifosRHHRA.pdf 4 Zhao, Q., Dourson, M., and GadagbuL B., 'fl review of the reference dose for chlorpyrifos," Regulatory Toxicology and 

Pharmacology Volume 44, Issue 2, March 2006; EPA Chlorpyrifos Human Health Risk Assessment (2000); and EPA 

Chlorpyrifos Revised Human Health Risk Assessment (2016) 

s Zhao, Q., Gadagbul, B., and Dourson, M., "Lower birth weight as a critical effect of chlorpyrifos: A comparison of human 

and animal data," Regulatory Toxicology and Pharmacology Volume 42, Issue 1,june 2005 

"See pp. 384-5 of the transcript of the FIFRA SAP Panel meeting, available at 

https:/ jwww.epa.gov lsiteslproductionlfilesl20 16-

0 5 I documents I fifra_sap _ 0 4_19 _16 _to_ 0 4_21_16 _final_transcript.pdf 
660 

Senator MERKLEY. Thank you. 

This letter states, ‘‘The nomination of Mr. Dourson to be in 

charge of chemical safety at the EPA is a threat to our nation’s 

children, farm workers, communities at the front lines of exposure 

to chlorpyrifos.’’ 

Flame retardants are chemicals that are used in everything from 

car seats to couches. EPA has placed many of these chemicals on 

its list of chemicals it wishes to examine first under TSCA. Ten 

years ago the biggest companies that made these chemicals formed 

an organization, Citizens for Fire Safety, to promote their use. 

In 2012 the group was found to have paid doctors to testify 

against proposed legislation to ban the chemicals. These doctors described heartbreaking stories about burned children who died in 

their arms, but might have been saved if only flame retardants had 

been used on their burning sheets and pillow cases. 

Just one problem—those children did not exist. These stories 

were fabricated. Citizens for Fire Safety folded in 2012, right after 

this shameful scam was exposed. And I note this because the very 

same flame retardant manufacturers that backed Citizens for Fire 

Safety then announced they would continue their advocacy efforts 

through the North American Flame Retardant Alliance, which was 

part of the American Chemistry Council. That Alliance consistently 

promotes the use of flame retardants, downplays the risk to health, 

lobbies against proposals to regulate them. 

Mr. Dourson, according to documents you provided the Committee, you were a member of the North American Flame Retardant Alliance Scientific Advisory Council from early 2012 until just 

a couple months ago. You list being paid $10,000 in consulting fees. 

You have led research funded by the same flame retardant companies that were backing the Citizens for Fire Safety and the Alliance. 

Having taken this employment, this advocacy, it is simply hard 

to conclude how you can be an objective and impartial regulator 

when it comes to these flame retardants. If confirmed, do you commit to recuse yourself from working on any chemical safety matter 

related to flame retardants? 

Mr. DOURSON. Senator, we have—TERA and the University of 

Cincinnati, has worked with a number of organizations for flame 

retardants, including Consumer Product Safety Commission, 

Health Canada, the National—— 

Senator MERKLEY. That is not the question I am asking. 

Senator BARRASSO. Senator, your time has expired. 

Senator MERKLEY. It is a simple yes or no question. 

Senator BARRASSO. And there is a second round. We will have 

plenty of time for a second round of questions. 

Senator MERKLEY. Yes or no, Mr. Dourson? Can you answer the 

question? 

Senator BARRASSO. I ask all members to keep this in their 5 

minute rounds. 

Senator MERKLEY. Well, we would be done if he would answer 

the question, Mr. Chairman. It is a simple yes or no question. 

Mr. DOURSON. I will rely on the guidance from the EPA ethics—— 

Senator MERKLEY. That is not sufficient. Thank you. 

661 

Mr. DOURSON [continuing]. To determine any issues—— 

Senator BARRASSO. You will have time for a second round of 

questions to further pursue. 

I would like to introduce for the record a letter from Dr. James 

Klaunig, who served as Indiana’s State Toxicologist for over a decade, is now Professor of Indiana University School of Public Health, 

who wrote, ‘‘Dr. Dourson is an exceptional scientist and leader in 

the fields of risk assessment and toxicology. As the Assistant Administrator of the EPA Office of Chemical Safety and Pollution, he 

would bring over a generation of experience in chemical safety and 

human risk assessment’’ to submit for the record. 

[The referenced information follows:] 

662 


27172.622

SCHOOL OF PUBLIC HEALTH 

July 12, 2017 

INDIANA UNIVERSITY 

Department of l:nvironmcntal Health 

Bloomington 

The Honorable Senator John Barrasso, 

Chairman, Environment and Public Works Committee 

United State Senate 

413 Dirksen Senate Office Building 

Washington, DC 20510 

Attn: Matt_Leggett@epw.senate.gov 

RE: Nomination of Dr. Michael L Dourson for Assistant Administrator of the EPA 

Office of Chemical Safety and Pollution Prevention 

Dear Senator Barrasso: 

I am writing in support of the nomination of Dr. Michael L Dourson for 

Assistant Administrator ofthe EPA Office of Chemical Safety and Pollution 

Prevention. My name is James E Klaunig. I am currently Professor of Environmental 

Health and Toxicology at Indiana University. I have been involved in the basic 

research and applied research of the possible effects ofagro chemicals and 

pharmaceuticals on humans for the past 40 years. I have served on US EPA and 

USFDA review panels and have chaired review panels for the USEPA for its human 

health strategy and environmental carcinogenesis programs. I have also served as a 

member of the US National Toxicology Board of science advisors. My research has 

been support by the USEPA, NIH, State of Indiana and corporate entities. Prior to 

joining the Indiana University School of Public Health I served as the Professor and 

Director of Toxicology at Indiana University School of Medicine. In this position I 

also served as the State Toxicologist for the State of Indiana as well as the Associate 

Director of the IU Cancer Center. I have also served Indiana on its pesticide review 

board, Governor's council on impaired and dangerous driving, and the controlled 

substances advisory Board. For this service to the State of Indiana I was honored 

by the Governor of Indiana with the Sagamore of the Wabash award (highest award 

to a citizen of Indiana for service to the State). I have published over 250 peer 

reviewed manuscripts and book chapters. My research has been highly cited as 

evident by my designation of one of 135 highly cited researchers in toxicology and 

pharmacology worldwide by the web of science 

(http:/ /hcr.stateofinnovation.com/). A copy of my curriculum vitae can be found on 

the webpage, Klauniglab.com. 

I have known and been familiar with the work of Dr. Dourson for over 30 

years. Dr. Dourson is a leader in the field of risk assessment, predominantly with 

1025 E. Seventh Street SPH C036 Bloomington, IN 47405 (812) 856-2448 fax (812) 856-2488 www.envh.indiana.edua 
663 


27172.623

the application of peer reviewed science to the human risk assessment. He has been 

instrumental in bringing scientists of difference disciplines and representing 

different constituents together to address current and future approaches to the risk 

of humans to exogenous chemicals. He is currently a Professor in the Risk Science 

Center in the University of Cincinnati, College of Medicine. Before joining the 

University Dr. Dourson was the founder ofthe Toxicology Excellence for Risk 

Assessment Center (TERA). Prior to forming and directing TERA, he worked for 15 

years in the U.S. Environmental Protection Agency in numerous leadership 

positions. He has been elected to multiple officer positions in the American Board of 

Toxicology (including its President), the Society of Toxicology (including the 

presidency of 3 specialty sections), the Society for Risk Analysis (including its 

Secretary), and is the President ofthe Toxicology Education Foundation, a nonprofit 

organization with a vision to help our public understand the essentials oftoxicology. 

In addition to numerous appointments on government panels, such as EPA's Science 

Advisory Board, he is also a member on the editorial board of Regulatory Toxicology 

and Pharmacology, Human and Experimental Toxicology and Toxicology Sciences. 

He extensive service to the disciplines of toxicology and risk assessment has 

resulted in numerous awards including 4 bronze medals at EPA, the Arnold J. 

Lehman award from the Society of Toxicology, and the International Achievement 

Award by the International Society of Regulatory Toxicology and Pharmacology. Dr. 

Dourson has also been elected as a Fellow ofthe Academy of Toxicological Sciences 

and as a Fellow for the Society for Risk Analysis. 

Besides his leadership in toxicology and risk assessment Dr. Dourson has 

published over 150 peer review manuscripts as well as over 100 government 

regulatory risk assessment documents dedicated to risk assessment methods and 

toxicology. He is also frequently called upon to chair symposium and workshop 

sessions at national and international scientific meetings. 

Dr. Dourson is an exceptional scientist and leader in the fields of risk 

assessment and toxicology. As the Assistant Administrator of the EPA Office of 

Chemical Safety and Pollution Prevention he would bring over a generation of 

experience in chemical safety and human risk assessment. I enthusiastically 

support the nomination of Dr. Michael Dourson for USEPA Assistant Administrator. 

Please contact me if you have any questions regarding this support letter. 

Sincerely, 

James E. Klaunig, PH.D., Fellow ATS, Fellow IATP 

Professor 

Environmental Health 

Indiana University 

1025 E 7th St 

Bloomington, IN 47405 

812 856 3957 

jklauni@indiana.edu 

klauniglab.com 
664 

Senator CARPER. Mr. Chairman, I would like to ask unanimous 

consent, if I could, to submit for the record an October 3rd letter 

from the International Association of Fire Fighters to members of 

this Committee. This letter expresses the Association’s strong opposition to the nomination of Dr. Dourson. 

Senator BARRASSO. Without objection. 

[The referenced information follows:] 

665 


27172.624

INTERNATIONAL ASSOCIATION OF FIRE FIGHTERS" HAROLD A. SCHAITBERGER 

General President 

October 3. 2017 

The Honorable john Barrasso 

Chairman 

Committee on Environm-ent and Public Works 

Washington, DC 20510 

EDWARD A. KELLY 

Genera! Secretary· Treasurer 

The Honorable Thomas R. Carper 

Ranking Member 

Committee on Environment and Public Works 

Washington, DC 20510 

Dear Chairman Barrasso and Ranking Member Carper, 

On behalf of the nation's 305,000 professional fire fighters and emergency medical personnel, we 

urge you to oppose the nominlltion of Michael Dourson to be Assistant Administrator of EPA's 

Office of Chemical Safety and Pollution Prevention. Michael Dourson's long career as a toxicologist 

paid by industry to work on the same chemicals he will be in charge of at EPA, including tlame 

retardants, is a recipe for disaster for fire fighters. 

The scientific evidence demonstrates fire fighters have higher incidences of cancer compared to 

other occupations, and that these cancers are specifically related to the job of fire· fighting. For 

example, the Nationallnstitute for Occupational Safety and Health (NIOSH) found the chance of fire 

fighter lung cancer diagnosis or death and the chance of fire fighter leukemia death increased with 

tirne spent fighting flre and the number of fire runs, respectively, 

In the course of duty, fire fighters are exposed to toxic chemicals including tlame retardants applied 

to upholstered furniture and many other household products. ln work paid by NAFRA, Dourson 

concluded that the flame retardant tetrabromobisphenol A (TBBPA)-an EPA work plan 

chemical-is not likely to be a reproductive or developmental toxicant. Numerous other studies 

indicate just the opposite. Dourson's consistent record of reaching conclusions not supported by 

other scientific experts including those in state and federal regulatory agencies raises serious 

concerns. 

The !AFF is committed to protecting the health and safety of the public as well as its members. We 

need real facts about the safety of the chemicals our members come in contact with, 

The !AFF is deeply concerned and is committed to protecting the health and safety of its members, 

and preventing toxic occupational exposures that put their health at significant risk. Michael 

Dourson's long record undermining efforts to shed light on the toxicity of flame retardants leaves 

us little doubtthat he is the wrong man to lead EPA's Office of Chemical Safety and Pollution 

Prevention. Again, we urge you to oppose his nomination. 

Sincerely, 

Harold A Schaitberger 

General President 

1750 NEW YORK AVENUE, N.W., WASHINGTON, D.C. 20006·5395 • {202) 737·8484 ·FAX (202) 737-84 tll· WWW.IAFF.ORG 
666 

Senator BARRASSO. Senator Fischer. 

Senator FISCHER. Thank you, Mr. Chairman. 

Mr. Wehrum, last week the EPA proposed to dramatically 

change the RFS in a proposal that is typically just a request for 

additional data. Moreover, there are press reports that EPA wants 

to attach a compliance credit to exported biofuels, an act that 

would completely undermine the integrity of the program, not to 

mention, I believe, harm the reputation of the United States as a 

fair trading partner. 

I have some real concerns with the approach that the Agency has 

recently taken on the RFS, especially after Administrator Pruitt 

committed to me, in this room, as he did to Senator Ernst, he also 

committed to me in two private meetings to uphold the law as intended. 

As you are aware, the RFS is the law until 2022. Are you aware 

of that? 

Mr. WEHRUM. And beyond, Senator, yes. 

Senator FISCHER. And beyond. The EPA could look at it after 

2022, is that correct? 

Mr. WEHRUM. That is correct, Senator. 

Senator FISCHER. What are your thoughts on the EPA’s, I believe, attacks on the RFS that we have been seeing lately? 

Mr. WEHRUM. Senator, as I responded to Senator Ernst earlier, 

the RFS is a very complicated program, and I am not apprised of 

all of the recent actions and all of the recent activity under the 

RFS, but it certainly will be one of my primary responsibilities, if 

confirmed to this position; and as I committed to Senator Ernst, I 

will commit to you that I will work very closely with you and with 

your staff and with your constituents to understand your concerns, 

and my goal would be to implement the RFS as faithfully and completely as I could, Senator. 

Senator FISCHER. And as Senator Ernst asked, would you commit 

that the RFS is the law, and it is in law until 2022? 

Mr. WEHRUM. Senator, there is no doubt the RFS is in law. It 

is included in the Clean Air Act; it was an amendment to the Clean 

Air Act. 

Senator FISCHER. Until 2022, at the earliest, when the EPA 

could look at it? 

Mr. WEHRUM. Yes, Senator. So the statute specifies renewable 

volume obligation goals through 2022, and then leaves it to the discretion of the Administrator, in consultation with others, to determine what those goals might be beyond 2022. 

Senator FISCHER. The Assistant Administrator of the Office of 

Air and Radiation plays a key role in ensuring the RFS functions 

according to congressional intent. And with the President’s commitment to the RFS and the biofuel production that we see, would you 

commit to upholding the President’s commitment? 

Mr. WEHRUM. The President, Senator, would be my ultimate 

boss, so our job is to implement the policy as the President specifies. 

Senator FISCHER. According to the law. 

Mr. WEHRUM. According to the law, that is absolutely correct. 

667 

Senator FISCHER. Do you think that the EPA has the authority 

to artificially reduce biofuel blending that runs counter to the intent and the literal reading of the RFS law? 

Mr. WEHRUM. Well, Senator, I have said a couple times the statute is pretty extensive, the statutory provisions; they go on for 

many pages in the Clean Air Act, and the regulations are even 

more extensive than that. What I do know is that there is discretion built into the law for the Agency and others to use in making 

sure that the law can be implemented according to the law, but 

also be effective as a practical matter. 

So I understand much of the concern is with regard to how that 

discretion has been implemented, and again, I will fully commit to 

you that, if confirmed to this position, that I would work very closely with you to understand your concerns, to understand the concerns of your constituents, and to try to implement the law as best 

we can. 

Senator FISCHER. Do you believe it is the intent of the RFS to 

increase the production of American made renewable fuels and also 

to decrease our country’s reliance on foreign oil? 

Mr. WEHRUM. I believe there is no doubt that that is the case, 

Senator. 

Senator FISCHER. And is it in the best interest of our national 

security that we have a reliable, stable fuel supply? 

Mr. WEHRUM. I believe that to be true, and energy security clearly was one of the motivating factors behind the enactment of the 

RFS, Senator. 

Senator FISCHER. And do you believe it was also the intent of the 

legislation to have a balanced portfolio when it comes to our energy 

sources in this country? 

Mr. WEHRUM. Senator, I am not exactly sure what you mean by 

that. I would be happy to respond; I am just not sure what you are 

getting at. 

Senator FISCHER. Well, I look forward to furthering our understanding of the situation in future conversations. 

Mr. WEHRUM. As do I, Senator. 

Senator FISCHER. Thank you. 

Thank you, Mr. Chairman. 

Senator BARRASSO. Thank you, Senator Fischer. 

Senator Markey. 

Senator MARKEY. Thank you, Mr. Chairman. 

Mr. Dourson, you and the organization you have led, known as 

Toxicology Excellence for Risk Assessment, have been routinely 

paid and funded by chemical companies and polluters defending 

the need for weakened chemical safety standard. For example, in 

2014 and 2017 you led two industry funded studies that defended 

a safe level of exposure to the carcinogen 1,4-dioxin that is 1,000 

times greater than EPA’s health based safety level; 350 parts per 

billion versus EPA’s .35 parts per billion. One thousand times 

greater exposure to dioxin. 

Dioxin is an industrial chemical found in a wide range of products and known to frequently contaminate water systems. According to water sampling studies conducted by the environmental 

working group Water Surprise, for more than 7 million Americans 

in 27 States are contaminated with the chemical at a level higher 

668 

than EPA’s health based standard. Just last year the EPA announced dioxin to be one of the first chemicals to be evaluated by 

the office to which you were nominated under the new Toxic Substances Control Act, which I helped to write. 

Given your recent work defending a 1,000 times weaker safety 

standard for dioxin than what the EPA determined will cause cancer, will you recuse yourself from working on this chemical if you 

receive confirmation for this position? 

Mr. DOURSON. Senator, I worked with a team of groups, including five different U.S. States, three different international organizations—— 

Senator MARKEY. Will you recuse yourself from the consideration 

of dioxin? 

Mr. DOURSON [continuing]. Several consulting firms, and several 

industries to advance the science that EPA put out in its 2013 document—— 

Senator MARKEY. Will you recuse yourself? Will you promise not 

to weaken the standard the EPA has set to protect the public’s 

health against the carcinogen dioxin? Will you not weaken that 

standard? 

Mr. DOURSON. If confirmed, I would bring new science and thinking into the Agency and—— 

Senator MARKEY. Your science says that dioxin can be exposed 

to by human beings at 1,000 times greater rate than the EPA has 

determined is safe for human beings. Will you recuse yourself? 

Mr. DOURSON. This new information is new information and new 

science since the time of the EPA document—— 

Senator MARKEY. I hear you. You are not going to give us a commitment, Mr. Dourson. And what is going to happen is, when you 

arrive at the EPA, you are going to have been the defendant’s 

chemical lawyer, who then becomes the judge over the very science, 

bogus science which you have been propounding. You are not just 

an outlier on this science; you are outrageous in how far from the 

mainstream of science you actually are. 

They are giving out the Nobel Prizes in chemistry this week. If 

there was a Nobel Prize in chemistry in reverse, you would be the 

clear winner this week in the United States and the world. This 

is an absolute atrocity. 

Let me move on, then, to TCE, a volatile organic compound and 

common industrial solvent that has been linked to cancer, congenital heart defects, other health issues. It is a route by which humans actually contract cancer. Because of the wide range of health 

concerns that can occur through even short-term exposure to TCE, 

the EPA has proposed banning TCE in commercial vapor 

degreasing and dry cleaning. Other uses of the chemical have been 

prioritized by the EPA for assessment under the updated TSCA 

law. 

A study you led and funded, Mr. Dourson, in 2016 proposed a 

safety range for TCE that is 1.5 to 15 times less protective than 

the EPA’s own drinking water standard. Given that the EPA will 

soon be finalizing its proposals on TCE for certain uses, and assessing the remaining uses for regulation, will you commit to not working to weaken the standards the EPA has already proposed? 

669 

Mr. DOURSON. Again, Senator, based on existing science, EPA 

came out with an assessment. Subsequent to that science, I worked 

with a consortium of individuals and groups of various sectors to 

bring additional science to EPA’s good questions. It is inappropriate 

for me to prejudge an issue, but if confirmed, I will ensure that the 

issue is fully and fairly considered in a publicly transparent manner. 

Senator MARKEY. Mr. Dourson, it is pretty clear that you have 

never met a chemical you didn’t like, and your previous studies 

have already prejudged the exposure. You are a scientist who already did work on this subject, and you have come to conclusions 

which are fundamental threats to the public health and safety of 

this country. You should commit here to recusal on the issues 

where you have already reached conclusions. 

Mr. DOURSON. The published paper we used, Senator, was using 

U.S. EPA safe doses and also EPA’s method for estimating ranges. 

Senator MARKEY. EPA found 1.5 to 15 times higher risk than you 

did, and that is not consistent with the conclusion—— 

Senator BARRASSO. There will be a second round of questions, 

Senator, for your opportunity. 

Senator Boozman. 

Senator BOOZMAN. Thank you, Mr. Chairman. I am about to lose 

my voice, but I did want to ask a couple questions. 

Mr. Ross, in recent years EPA has made it increasingly difficult 

for Arkansas to manage its delegated national pollutant discharge 

elimination program and responsibilities under the Clean Water 

Act. 

Too often, permits, rulemakings, or other actions sent to EPA for 

review were returned with demands for more restrictive requirements, additional expensive data collection, or other costly, onerous 

requirements. New leadership at EPA has an opportunity to correct 

this coercive federalism and instead restore cooperative federalism, 

as intended. 

The States have the expertise and local knowledge necessary to 

administer our environmental programs. The EPA has been proud 

to say that the States are essentially in charge and that they will 

defer to them, and that is true, as long as they agree with what 

the States come up with. 

I guess the question is EPA has the opportunity to play a significant role in supporting a move back to cooperative federalism. Can 

you please explain how you plan to change the EPA’s State dynamic? 

Mr. ROSS. Thank you for the question, Senator. I do believe 

strongly in cooperative federalism. One of the things that I have 

heard in the run up to this hearing, and also working for two different States over the last several years, is the frustration in the 

relationship between the Federal Government and the State government, and I commit to taking that head on. And one of the ways 

that I have heard is to make sure we get outside the Beltway; to 

go out, work with States, figure out the relationships, and listen 

and develop a common relationship on how best to manage our nation’s resources. 

Senator BOOZMAN. Very good. 

670 

Mr. Wehrum, more than 1,000 U.S. companies and organizations 

sent a letter to Congress and the Administration calling for lawmakers to preserve the voluntary Energy Star program that was 

recently proposed for elimination. This program, founded in 1992 

during the Bush administration, is an extremely successful publicprivate partnership model. Consumers enjoy the benefits of the 

program, which encourages innovation and has saved taxpayers 

over $430 billion since 1992. 

Do you view the Energy Star program as a successful public-private partnership? 

Mr. WEHRUM. Senator, Energy Star is a unique program, and 

products that are allowed to carry the Energy Star label must be 

shown to be cost effective, energy efficiency technologies, which 

means they pay for themselves over time, so a very strict criteria 

are applied to deciding where the Energy Star label can be applied. 

So it is a different kind of program because it is a voluntary program and not a mandatory regulatory program, and it is a program 

that has been widely used in many different industries. 

Senator BOOZMAN. So you think it has been successful? 

Mr. WEHRUM. Personally, I do believe it has been successful, 

Senator, yes. 

Senator BOOZMAN. Thank you. 

Dr. Dourson, for the past 8 years EPA has acted as a political 

arm of the Obama administration. Time and time again we have 

seen rules developed not based on sound science, but on political 

ideology. When rules have been released, States, the private sector, 

and even Congress have had trouble getting EPA to show the 

science that helped develop these rules. As an Assistant Administrator of the Office of Chemical Safety and Pollution Prevention, 

can we expect EPA to be more transparent as to how rules are developed? 

Mr. DOURSON. Yes, Senator. My career has been based on transparency and collaboration, and I intend to do so if confirmed. 

Senator BOOZMAN. Good. That is very, very important, to have 

access. It is one thing to come out with a finding, but certainly that 

needs to be transparent. We need to have the ability to see the 

science behind it. 

Thank you, Mr. Chairman. 

Senator BARRASSO. Thank you, Senator Boozman. 

Senator Booker. 

Senator BOOKER. Thank you, Mr. Chairman. 

Mr. Dourson, I have to say, and you have heard from my colleagues, that I have only been in the Senate for 4 years. But your 

nomination is one of the more shocking that I have seen, and your 

job that you are being nominated to, as my colleague just said, is 

to the Chemical Safety and Pollution Prevention Office, and the 

mission, as I hope you have memorized, frankly, is to protect families and the environment from the potential risks from pesticides 

and toxic chemicals. 

You heard already from some of my colleagues; Senator 

Duckworth talking about the south side of Chicago. I live in a community that has seen the effects of corporate villainy to the point 

now that our soil is poisoned; we can’t plant many places in our 

city. The air is poisoned, asthma rates, lead poisoning rates, the 

671 

water is poisoned because corporations, pressing their hand and 

their power and their money, have been able to poison communities 

to the extent that you have autism rates, birth defects, cancers in 

our children in places in this country that are unconscionable. 

And I really hope, as you sit there on your perch right now, that 

you have the capacity to have empathy for those people, many of 

whom are sitting behind you right now, who view your nomination 

with fear, with anguish. And that fear and anguish is not partisan; 

it is not coming from the thin air. As you have heard from my colleagues, it is coming from looking at your record. 

I would imagine that somebody would be nominated that has a 

track record of standing up for those vulnerable people in our nation. But my colleague after colleague has now pointed out what 

you have been doing with your professional career. And I will just 

go through, because it almost seems like a bit of a scene out of 

some Disney movie where there are corporate villains that do harm 

to our environment, or at least seek to if it weren’t for the heroic 

actions of others. 

So, this is the process. First, a company or industry identifies a 

problem, and you have already talked to Dow and Monsanto and 

chemical companies like this, and they want to exercise influence 

to stop safety measures being done by governments. So, what happens is that the corporation hires your organization, TERA, to come 

up with a recommendation, a safety standard so that they can try 

to defend their desire to put more poisons into the atmosphere, into 

the soil, and into our water. So, what happens is that you come up 

with the science to back up these corporations. 

But I try to give this a fair measure. I mean, the surface information I received was so astonishing that you would be sitting 

where you are as a nominee that I wanted to dig into some of the 

stuff, and came up with the same things that other folks came up 

with. You have heard these chemicals now mentioned by my colleagues—alachlor and acetochlor. They are banned in the European 

Union. Literally banned. You all advocated for limits in the water 

based on your science that ended up being 280 times higher than 

the State of Wisconsin believed was safe for their kids. 

So, I know that you can pick your chemical here. The pattern I 

have seen from just looking at your record, sir, goes again and 

again and again. Corporations fund studies from TERA and have 

science on here is chlorpyrifos that literally comes out. Your studies, this one, in the case of that chemical, that affects farm workers 

and children, was 1,000 time higher than the ultimate EPA standard. A thousand times higher. 

So clearly, to me, we have a situation where you are about to be 

the person that is a head of an office that has the mission of protecting children, and you have a pattern of working with corporations to advocate for a position that is hundreds, if not thousands, 

of times more dangerous than the standards we set and that we 

see other nations who are moving to ban the very chemicals that 

you have been advocating for as safe at higher levels. 

The Chairman said that you have been a leader, read a letter 

that calls you a leader in human risk assessment. I don’t see this 

as leadership when you are advocating for levels that will literally 

poison people. It doesn’t make you seem like a leader in your caVerDate Aug 31 2005 12:28 Nov 09, 2017 Jkt 000000 PO 00000 Frm 00677 Fmt 6633 Sfmt 6633 S:\_EPW\DOCS\27172.TXT SONYA
672 

reer; it seems like you are a lackey, a corporate lackey doing the 

bidding of people that are trying to create in communities like the 

one I live in, where my niece was born, to create environments that 

are chemically toxic. 

So, I have heard you not answer this question over and over 

again, but I am appealing to you to recuse yourself. It seems logical 

and legal that you would recuse yourself from making decisions on 

chemicals from companies that have paid you. And I don’t understand any defense to that. If these corporations were going to be 

advocating for standards that you set at levels that poison human 

beings, it seems logical that you should not be now the judge of 

whether those chemicals should be released, or changing standards 

that now will reflect what those corporations wanted. 

So, I doubt I am going to get it, but will you recuse yourself, sir? 

Mr. DOURSON. Senator, I will follow the EPA ethics officials’ determination for any recusal. 

Senator BOOKER. And that is the point I will conclude with, sir, 

because you are going to follow the ethics that you think that the 

EPA is going to give you, and I am talking to you not just about 

ethics and law, but I am talking to you about conscience and moral 

values. 

And it seems like you have been willing to bend those ideals, because I don’t know if you have children, I don’t know if you have 

grandchildren, I don’t know if you have nieces or nephews like me, 

but I doubt you would let them live next to the companies that are 

spewing this stuff in the air. You would not let them live there and 

accept standards in their atmosphere that you have been claiming 

for your entire career are safe. You would not do it. But you are 

advocating for positions, and there are people here right now, you 

are advocating for positions that are going to endanger those children that are in those communities. 

Thank you very much. 

Senator BARRASSO. And there will be time for a second round of 

questioning. 

I would like to submit for the record a letter by Dr. Jennifer 

Seed, who has worked for 23 years in various positions at the Office of Pollution Prevention and Toxics at the EPA, who wrote that 

Dr. Dourson has a long history of supporting regulatory agencies 

both at the State and Federal level. As an EPA employee, he 

played a paramount role in the development of risk assessment 

practices that are now used internationally. 

Unanimous consent that the letter be admitted. 

[The referenced information follows:] 

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From: Jennifer Seed [mailto:jseed89770@aol.com] 

Sent: Saturday, July 22, 2017 2:02PM 

To: Leggett, Matt (EPW) <Matt Leggett@epw.senate.gov> 

Cc: palich.christian@epa.gov 

Subject: A note in support of Dr. Michael Dourson as AA of OCSPP 

Senator John Barrasso, 

I am writing in support of the nomination of Michael Dourson as AA of the Office of Chemical 

Safety and Pollution Prevention (OCSPP). I retired from the EPA in 2014. I worked in the Office 

of Pollution Prevention and Toxics (one of the Offices in OCSPP) for 23 years in various positions 

including Biologist, Senior Science Advisor, Branch Chief, and Deputy Director oft he Risk 

Assessment Division. During that time, I had interactions with Dr. Dourson, both when he was 

an employee of EPA and later when he founded TERA. I know you are aware of his extensive 

toxicology and risk assessment background so I will not dwell upon that here. I am also aware 

that some objections have been raised due to his work with industry. I would just like to take 

this opportunity to point out that Dr. Dourson has a long history of supporting regulatory 

agencies, both at the State level and the Federal level. As an EPA employee, he played a 

paramount role in the development of risk assessment practices that are now used 

internationally. He has worked with states to develop assessments. He has worked to 

harmonize risk numbers internationally. I would also point out that he had a 5 year cooperative 

agreement with my prior Division and Office in EPA to develop a peer consultation process and 

to use the assessments that were being done under OPPT's Voluntary Childrens' Chemical 

Evaluation Program (VCCEP) as examples. This was done with the utmost professionalism. 

Sincerely, 

Jennifer Seed, Ph.D. 

Retired from EPA 
674 

Senator CARPER. Mr. Chairman, I would also like to ask unanimous consent to submit for the record a September 19th letter from 

several environmental organizations to members of our Committee, 

and on behalf of their millions of members, these organizations 

write to oppose the nominations of Dr. Dourson and Mr. Wehrum. 

It has raised serious concerns regarding the nominations of Mr. 

Ross and Mr. Leopold to their respective positions at the Environmental Protection Agency. 

Senator BARRASSO. Without objection. 

Senator CARPER. Thank you. 

[The referenced information follows:] 

675 


27172.626

Sierra Club* Earthjustice *League of Conservation Voters 

Rachel Carson Council * American Sustainable Business Council 

Oil Change International* Waterkeeper Alliance* Center for Biological Diversity 

NextGen America * Safe Climate Campaign 

September 19,2017 

Dear Senator, 

On behalf of our millions of members, the undersigned organizations write to raise serious 

concerns regarding the nominations of Bill Wehrum for Assistant Administrator for the Office of 

Air and Radiation, Dr. Michael Dourson for Assistant Administrator of the Office of Chemical 

Safety and Pollution Prevention, David Ross for Assistant Administrator for the Office of Water, 

and Matt Leopold to serve as General Counsel for the Environmental Protection Agency. 

A closer inspection of the careers and writings of each of these candidates will reveal many 

instances where their views and actions are in opposition to policies and safeguards that would 

protect our air and water, our health, and our communities from toxic pollution and that they 

have pursued these ends through work inside and outside of government. 

Bill Wehrum, nominee for Assistant Administrator for the Office of Air and Radiation, both 

during his tenure at EPA and as an industry lobbyist, actively worked to undermine the air 

pollution safeguards and public health protections guaranteed under the Clean Air Act. From 

2001 to 2007, Wehrum worked in EPA's Office of Air and Radiation, serving as Acting 

Assistant Administrator from 2005 to 2007 when his nomination for Assistant Administrator was 

withdrawn, having failed to secure the 60 votes needed for confirmation. While at EPA, Wehrum 

led efforts to weaken standards to reduce mercury emissions from coal fired power p !ants. In 

addition to mercury, Wehrum sought to weaken and roll back safeguards against lead, fine 

particulate pollution, and ozone smog. Rules proposed during Wehrum's EPA tenure included 

language copied verbatim from Latham & Watkins memorandums, the firm where Wehrum was 

previously employed and worked on behalf of utilities and polluting energy companies to 

influence rules issued under the authority of the Clean Air Act. Wehrum's tenure at EPA also 

marked a series of high profile legal cases brought against the Agency for efforts to roll back, 

weaken, or avoid action on protections under the Clean Air Act. EPA lost 27 cases during this 

time and was repeatedly admonished by federal courts for its violation of the plain language of 

the law--the DC Circuit Court of Appeals went so far as to say EPA arguments "deploy[ ed] the 

logic of the Queen of Hearts, substituting EPA's desires for the plain text of' the law. These 

cases, brought on by EPA's favor of industry, delayed or blocked pollution safeguards, resulting 

in grievous harm to public health and air and water quality. Wehrum's opposition to the 

fundamental health protections guaranteed under the Clean Air Act and his disturbing record of 

work to roll back, delay, and weaken pollution safeguards illustrate that he is grossly unfit to 

serve in a position charged with ensuring clean air and protecting public health. 

Dr. Michael Dourson, nominee for Assistant Administrator at EPA's Office of Chemical Safety 

and Pollution Prevention, has made a career of supporting industry polluters and distorting the 
676 


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facts ofthe toxic effects of substances like chlorpyrifos, TCE, PFOA, and 1,4 dioxane. Dourson 

was a chief defender of tobacco, distorting the health effects to benefit the industry at the 

expense of public health. Through his work as a toxicologist, and through his firm, Toxicology 

Excellence for Risk Assessment (TERA), Dourson has cultivated a close relationship with 

chemicals manufacturers and associations, working under the false aegis of "independence" to 

obscure the public health hazard posed by chemicals, pesticides, and other toxic substances. 

Dourson's TERA received "financial and in-kind support" from these same companies and 

chemicals manufacturers, at times receiving payment to review studies favored by the industry 

for inclusion in its database-- these ties call into serious question Dourson's ability to be an 

effective and impartial regulator of industry. Dourson' s risk assessment firm, TERA, was 

responsible for the "Kids + Chemical Safety" website which has been alleged to advance 

industry positions and downplay health and exposure risks, particularly for children, of toxics 

present in household items, including toys. Dourson's record of inaccurately representing the 

health risks oftoxic chemical exposure and downplaying the potential for harm, particularly to 

children, make clear that Dourson should not be charged with protecting the health of children 

and families from toxic chemicals. 

David Ross, nominee for Assistant Administrator at EPA's Office of Water, is an environmental 

attorney and state government official. Ross has been an attorney in private practice and in 2014 

was named Director of the Environmental Protection Unit at Wisconsin's Department of Justice. 

Ross' practice has focused on the Clean Water Act, RCRA, and CERCLA and both his record, 

and the circumstances of his tenure at Wisconsin's Department of Justice are concerning. Under 

his leadership, Wisconsin's Environmental Protection Unit both saw significant decreases in staff 

capacity, "[shrinking] to its smallest size in 25 years," and a significant decrease in the fines it 

sought from polluters. Ross is alleged to have taken a light hand in pursuing pollution violations, 

declining to assess fines and instead deferring to polluters and relying on compliance schemes, as 

opposed to assessing penalties in the course of settlement. This has weakened the Unit's 

enforcement priorities, shifting the office into a more partisan role. Ross' disinclination to take 

meaningful action to address pollution violations and the decrease in both the vigor of, and 

capacity for, enforcement action during his tenure at the Wisconsin Department of Justice 

Environmental Protection Unit are concerning given that the responsibilities of the Office of 

Water are to ensure protections for water and to safeguard families against toxic runoff, 

pollution, and discharges. 

Matt Leopold, nominee for General Counsel at EPA has been an outspoken critic of the Agency 

and its efforts to regulate pollution and issue safeguards. Leopold's legal career has focused on 

the environment, both in private practice and as general counsel with the Florida Department of 

Environmental Protection. In a speech to the Federalist Society in Florida, Leopold argued 

against greater involvement by federal regulators in air, water, and land protections; he suggested 

that state governments should fill this role and questioned the authority of the EPA to exercise its 

regulatory powers. While with the Florida DEP, Leopold's role in the firing of two 

environmental lawyers was questioned over concerns that the terminations were made on 

partisan grounds. At the same time, Leopold presided over a steep decline in enforcement action 

brought by the Department. This raised concerns about a 'cozy' relationship with developers and 

polluters. Leopold's position on the Clean Power Plan is also concerning, and while he has said 

the EPA's authority to regulate greenhouse gases is settled law, he has questioned if the EPA is 
677 


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exceeding its authority by looking outside emissions from power plants. As General Counsel, 

Leopold would play a key role in Administrator Pruitt's plan to roll back the Clean Power Plan, 

and in the ongoing efforts to roll back, weaken, or rescind safeguards issued by the Agency. 

Given his poor record of enforcement and his position on EPA's authority to regulate pollution, 

entrusting Leopold with the responsibility of General Counsel raises troubling concerns. 

We urge your consideration of the above and request your careful evaluation of Ross and 

Leopold. The nominations of Bill Wehrum and Dr. Michael Dourson undermine public 

confidence in the Agency and paint a grim picture for the future of enforcement of our bedrock 

environmental laws, like the Clean Air Act and Clean Water Act. Each of these individuals have 

demonstrated a willingness to advance the agenda of polluters and industry before health 

protections and safeguards for clean air and clean water. Their close ties to industry, including 

the very companies and industries they would be charged with regulating, are alarming and 

would only add to the disturbing alignment of political staff at EPA under Administrator Pruitt 

with outside interests, instead of the American people. We urge you to oppose their nominations. 

Sincerely, 

Sierra Club 

Rachel Carson Council 

Earth justice 

League of Conservation Voters 

American Sustainable Business Council 

Oil Change International 

Waterkeeper Alliance 

Center for Biological Diversity 

NextGen America 

Safe Climate Campaign 
678 

Senator BARRASSO. Senator Rounds. 

Senator ROUNDS. Thank you, Mr. Chairman. 

Dr. Dourson, if you are confirmed to lead the Office of Chemical 

Safety, you will be responsible for implementing the TSCA reforms 

passed by Congress last year. This Committee has a strong interest 

in making certain that TSCA reforms are implemented properly 

and in a timely fashion. 

Can you commit to us that you will keep Congress apprised of 

the status of TSCA implementation and answer congressional requests for information about the program? 

Mr. DOURSON. Yes, Senator. As I said in my opening statement, 

the Lautenberg Chemical Safety Act was a significant milestone, 

celebrated broadly by scientists in my sector, so I will commit to 

working with this Committee and Congress to make sure it is implemented correctly. 

Senator ROUNDS. Dr. Dourson, in the prior administration we 

heard reports of the EPA not using up to date or the most relevant 

science when making chemical safety decisions. Can you explain to 

me your views on the importance of science at the Agency, particularly in the decisions being made by the Office of Chemical Safety? 

Mr. DOURSON. Senator, good science and use of good science is 

a touchstone of everything that U.S. EPA does, and other Federal 

agencies, I am sure, as well. Bringing good science and doing it in 

a collaborative and transparent manner has been my life’s passion. 

Collaboration is important, and if confirmed, I will work with the 

talented people of the Office of Chemical Safety and Pollution Prevention and make sure that the best science is looked at and reviewed, and used to protect the public health, including the most 

vulnerable members of our population. 

Senator ROUNDS. Let me get into this a little bit more, because 

when we talk about sound science, and we talk about good science, 

the science community has a unique way of looking at the way that 

it is reviewed, the way that we go about establishing the processes, 

and so forth. You are a scientist. Can you share with the Committee your analysis of what makes good science and sound science, 

and what the expectations should be of this Committee of the EPA 

in the way that they set up work with the science community to 

develop recommendations based on sound science? What goes into 

it? 

Mr. DOURSON. Well, the sound science, if you would take a particular chemical, it doesn’t matter which one for an example, you 

would look at all the available information on that particular chemical. 

Senator ROUNDS. Who looks at it? Who looks at the information? 

Mr. DOURSON. Well, it would be the scientists within the Office 

of Chemical Safety and Pollution Prevention, and it could be exposure science, it could be toxicology, it could be epidemiology. But 

you bring all this together, and you work with teams within the organization to review all this data. The next step is to look and winnow out and use the most significant or credible science on which 

to make the basis, your assessment of chemical safety or exposure. 

And once that determination is made, you do this in an open fashion, you ask for information, then you have an independent peer 

review. 

679 

Senator ROUNDS. Talk about that a little bit. I think that is the 

important part here that sometimes gets missed. 

Mr. DOURSON. Well, the independent peer review, U.S. EPA has 

several ways to do this, and they have several very good organizations within U.S. EPA. The Science Advisory Board, of which I 

have served as a member until just a couple days ago when my 6- 

year term was up, is an example of very good independent peer review. They are independent of the Agency, the group within EPA 

that does this, and they bring scientists from the outside sector 

that are multiple disciplines and also multiple sectors in to review 

the information that EPA puts out. That is very important. 

Another important thing is access to all of the available data. 

There are sometimes studies you don’t have access to the raw data. 

Sometimes that is difficult to make decisions in that case. 

Senator ROUNDS. OK. 

Mr. Ross, in the last Administration we uncovered several instances in which regulations were promulgated by the EPA without 

taking into consideration the opinions of the Science Advisory 

Board or not properly submitting information to the Science Advisory Board to review prior regulating. 

If confirmed, will you commit to relying on the best available 

science when regulating? 

Mr. ROSS. Absolutely, Senator. I think sound science, together 

with the proper application of law, are the twin pillars of sound 

Government policy decisionmaking, so absolutely. 

Senator ROUNDS. Thank you. 

Thank you, Mr. Chairman. 

Senator BARRASSO. Thank you very much, Senator Rounds. 

Senator Harris. 

Senator HARRIS. Thank you. 

Mr. Wehrum, section 209(b) of the Clean Air Act recognizes California’s authority to increase air pollution standards for new motor 

vehicles. I am sure you are familiar with that. 

Mr. WEHRUM. I am, Senator. 

Senator HARRIS. And I have an e-mail that is dated March 15th, 

2006, from you to the EPA staff, where you told staff that you 

thought the EPA should preempt California and deny the waiver. 

And Mr. Chairman, I would like to enter that into the record. 

Senator BARRASSO. Without objection. 

[The referenced information follows:] 

680 


27172.629

EPA Email 

From: 

To: 

CC: 

Date: 

Subject: 

Bill Wehrum 

Staff at EPA Office of Transportation and Air Quality and EPA Office of 

Air and Radiation 

Staff at EPA Office of General Counsel 

3/1512006 4:45 PM 

CA Vehicle GHG Regulations 

... -I took another look at the briefing materials from late January. I think we should 

assert the existence of preemption and propose to deny the waiver based on the absence 

of compelling and extraordinary conditions. This determination would be specific to the 

GHG standard and should not generally apply to the other aspects of their LEV rule. I 

think it makes sense to ask for comment on some of the other key questions presented in 

the briefing, but not present them as our proposed alternative. 

Having said that, I also think that this issue goes far beyond OAR. ... ,will you please set 

up a briefing with Marcus ASAP to give him the background and seek his concurrence . 

... ,I'd like to adjust the January briefing package to include the recommended approach 

described above. We can talk about it more before going to Marcus if you or others have 

concern with this approach. Lastly, we will need to consult with our interagency 

breatheren before going forward with a Fed. Reg. notice. I'll get this started once we've 

touched base with Marcus. 

Thanks. 
681 

Senator HARRIS. Also, in 2008 there was a House Committee on 

Oversight and Government Reform investigation showing that the 

EPA career staff and lawyers unanimously and uniformly thought 

the waiver should be granted. 

And I have that document as well, Mr. Chairman, that I would 

like entered. 

Senator BARRASSO. Without objection. 

[The referenced information follows:] 

682 


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ONE HUNDRED TENTH CONGRESS 

qcongrtUU of tbt 1tnittb ~tattU 

Jl;loun of 3lepreutntatibes 

COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM 

2157 RAYBURN HouSE OFFICE BuiLDING 

WASHINGTON, DC 20515-6143 

~(202l226-60151 

F...csiMILI\(20:21225-4184 

WMlfWTY C20S!1225--SJT4 

www.cversighlhouse.gov 

MEMORANDUM 

May 19,2008 

To: Members of the Committee on Oversight and Government Reform 

Fr: Committee on Oversight and Government Reform, Majority Staff 

Re: EPA's Denial of the California Waiver 

lQMO.O.'IIS,VIA!.'IINIA, 

FW«<NGII.!IMClRITY!IoEMBER 

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PATRIC:KT. MCHENRV, MOfml CAROLINA vmGINIA FOXX. NORTH CAROliN'. BRIAN P. t1U3MY, CAI.lFORMA 81U..SNJ,IDAHO 

JlU~.otflO 

For the· past five months, the Oversight Committee bas been investigating the decision by 

the Environmental Protection Agency to reject California's petition to regulate greenhouse gas 

emissions from cars and trucks. During the course of the investigation, the Committee obtained 

over 27,000 pages of documents from the Environmental Protection Agency (EPA) and deposed 

or interviewed eight key officials. Tills memorandum summarizes some of the significant 

evidence the Committee bas received. 

The record before the Committee shows: (1) the career staff at EPA unanimously 

supported granting California's petition; (2) Stephen Johnson, the Administrator of EPA, also 

supported granting California's petition at least in part; and (3) Administrator Johnson reversed 

his position after communications with officials in the White House. 

The Position of EPA Staff. Internal EPA documents and transcribed interviews with 

EPA staff show that the agency career staff all supported granting the California petition. Tills 

recommendation and the reasons for it were communicated to the Administrator in several 

meetings. A September 21, 2007, meeting was significant. As one EPA staffer described it, 

"Administrator Johnson essentially polled the room on what people's final opinions were about 

granting or not granting a waiver." According to five EPA staff who were in the meeting, not a 

single staffer argued that the California waiver should be denied. 

A briefing prepared by the lead staff lawyer for EPA's General Counsel stated: "After 

review of the docket and precedent, we don't believe there are any good arguments against 

granting the waiver. All of the arguments ... are likely to lose in court if we are sued." 

Similarly, a briefing from the Office of Transportation and Air Quality and the Office of General 

Counsel stated: 
683 


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OT AQ and OGC are reviewing these options from a legal, technical, and waiver 

precedent perspective and other options may fall in or out of our review. The clearest 

and most defensible option is to grant the waiver. The other options have high to very 

high vulnerability to legal challenge. 

The EPA staff interviewed by the Committee were unable to identify any agency 

documents that argued in favor of denial prior to December 19, 2007, the day California's 

petition was denied. 

The Position of Administrator Johnson. EPA Associate Deputy Administrator Jason 

Burnett told the Committee that Administrator Johnson supported granting California's petition 

for a waiver of preemption under the Clean Air Act. In a deposition, he testified that 

Administrator Johnson "was very interested in a full grant of the waiver" in August and 

September 2007 and then thought that a partial grant of the waiver "was the best course of 

action." Mr. Burnett explained: "the Administrator was interested in initially a full grant, and 

became interested in a partial grant, asked for me and others to explore ways of making a partial 

grant work." 

According to Mr. Burnett's deposition testimony, Administrator Johnson's preference for 

a full or partial grant of the waiver did not change until after he communicated with the White 

House. When asked by Committee staff "whether the Administrator communicated with the 

White House in between his preference to do a partial grant and the ultimate decision" to deny 

the waiver, Mr. Burnett responded: "I believe the answer is yes." When asked "after his 

communications with the White House, did he still support granting the waiver in part," Mr. 

Burnett answered: "He ultimately decided to deny the waiver." Mr. Burnett also affirmed that 

there was "White House input into the rationale in the December 19th letter" announcing the 

denial of the waiver and in the formal decision document issued in March 2008. 

The Position of the White House. The record before the Committee suggests that the 

White House played a pivotal role in the decision to reject the California petition, but it does not 

explain the basis for the White House intervention. During his deposition, Mr. Burnett was 

asked to identify the White House officials who spoke with Administrator Johnson and to 

describe the substance of their communications with Administrator Johnson. Mr. Burnett 

informed the Committee that he had been directed not to answer any questions about the 

involvement of the White House in the decision to reject California's petition. 

The President has an obligation under the Constitution to take care that the laws of the 

United States are faithfully executed. In this case, the applicable law is the Clean Air Act, which 

requires that California's petition to regulate greenhouse gas emissions from motor vehicles be 

decided on the merits based on specific statutory criteria. It would be a serious breach if the 

President or other White House officials directed Administrator Johnson to ignore the record 

before the agency and deny California's petition for political or other inappropriate reasons. 

Further investigation will be required to assess the legality of the White House role in the 

rejection of the California motor vehicle standards. 

2 
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I. INTRODUCTION 

A. California's Waiver Request 

The Clean Air Act authorizes two sets of standards to control tailpipe pollution from 

motor vehicles: (1) federal standards and (2) state standards established by California, which can 

also be adopted by other states. Section 209(b) of the Clean Air Act requires EPA to waive 

federal preemption for California motor vehicle standards if the agency determines that 

California's standards in the aggregate will be at least as protective of public health and welfare 

as federal standards. EPA may reject a waiver request only if the Administrator finds: (I) 

California's determination regarding protectiveness is "arbitrary and capricious;" (2) California 

does not need state standards ''to meet compelling and extraordinary conditions;" or (3) 

California's standards are not consistent with statutory requirements for adequate lead-time and 

technological feasibility .

1 

The special authority for California to set its own motor vehicle standards was part of the 

Air Quality Act of 1967 and was retained when Congress adopted the originall970 Clean Air 

Act.2 This authority was expanded in the 1977 amendments, with Congress recognizing that ''the 

underlying intent" of section 209 is ''to afford California the broadest possible discretion in 

selecting the best means to protect the health of its citizens and the public welfare."3 

In internal documents, EPA has recognized that the language of section 209, its 

legislative history, court decisions, and consistent EPA interpretation of the provision over 

several decades all indicate that California has the "broadest possible discretion in developing 

[its] program, and EPA has only narrow and circumscribed discretion to deny a waiver to 

California.'"' According to these internal documents, the "[b ]urden of proof is on parties 

opposing a waiver," and "EPA traditionally looks broadly at whether [California] has conditions 

such that it still needs its own motor vehicle emission program. [EPA has] not examined the 

need and conditions for specific standards or specific air pollution problem[ s). "5 

1 Clean Air Act §209{b). 

2 See Motor & Equipment M:fts. Ass'n v. EPA ("MEMA 1''), 627 F.2d I 095, II 08-1111 

(D.C. Cir. 1979); Motor Vehicle Mfrs. Ass'n ofU.S., Inc. v. New York State Dept. of 

Environmental Conservation, 17 F.3d 521,525 (2"d Cir. 1994). 

3 H.R. Rep. No. 294, 95th Cong., 1st Sess. 301-02 (1977). 

4 Environmental Protection Agency, California Request for a Waiver of Preemption of 

GHG Standards, at 5 (Apr. 30, 2007) {briefing slides for Administrator Johnson). See also 

Motor & Equipment Mfrs. Ass'n v. EPA ("MEMA !"), 627 F.2d 1095, 1108-1111 (D.C. Cir. 

1979). 

5 Environmental Protection Agency, California Request for a Waiver of Preemption of 

GHG Standards, at 7, 10 (Apr. 30, 2007) (briefmg slides for Administrator Johnson). 

3 
685 


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In September 2004, California amended its existing motor vehicle regulations to include 

standards requiring cars and light-duty trucks to limit emissions of greenhouse gases.6 The 

standards begin with the 2009 model year and phase-in gradually over eight years. 7 By the 2016 

model year, they would cut global warming pollution from new vehicles by almost 30%.8 

Thirteen other states- Arizona, Connecticut, Maine, Maryland, Massachusetts, New Mexico, 

New Jersey, New York, Oregon, Pennsylvania, Rhode Island, Vermont, and Washington- have 

already adopted the California standards. Together, these 14 states' consumers buy over 40% of 

the new vehicles sold nationwide each year.9 

On December 21,2005, California requested that EPA grant a waiver of preemption 

under section 209(b) for the California greenhouse gas emissions standards. 10 EPA took no 

public action on the waiver request until the Supreme Court ruled in Massachusetts v. EPA on 

April 2, 2007, that greenhouse gases are air pollutants under the Clean Air Act.11 EPA then 

published a notice on April30, 2007, announcing a public hearing and a comment period on the 

waiver request. 12 The public comment period closed on June 15, 2007. 13 

6 California Environmental Protection Agency Air Resources Board, Final Regulation 

Order- Amendments to Sections 1900 and 1961 and Adoption of New Sections 1961.1, Title 

13, California Code of Regulations as Approved by OAL, California Exhaust Emission 

Standards and Test Procedures for 2001 and Subsequent Model Passenger Cars, Light Trucks 

and Medium-Duty Vehicles as Approved by OAL (Sept. 24, 2004 hearing date) (online at 

www.arb.ca.gov/regact/gmhsgas/grnhsgas.htm). 

7 California Environmental Protection Agency Air Resources Board, Request for a Clean 

Air Act Section 209(b) Waiver of Preemption for California's Adopted and Amended New 

Motor Vehicle Regulations and Incorporated Test Procedures to Control Greenhouse Gas 

Emissions: Support Document, at 6 (Dec. 21, 2005). 

8 California Environmental Protection Agency Air Resources Board, ARB Approves 

Greenhouse Gas Rule (Sept 24, 2004) (press release) (online at www.arb.ca.gov/newsrell 

nr092404.htm). 

9 Union of Concerned Scientists, Automakers v. the People (online at www.ucsusa.org/ 

clean_ vehicles/avpl) (accessed May 8, 2008). 

10 Letter from Catherine Witherspoon, Executive Director, California Air Resources 

Board, to Stephen L. Johnson, Administrator, U.S. Environmental Protection Agency, Re: 

Regulations to Control Greenhouse Gas Emissions From Motor Vehicles; Request for Waiver of 

Preemption Under Clean Air Act Section 209(b) (Dec. 21, 2005). 

11 Massachusetts v. EPA, 127 S.Ct. 1438 (2007). 

12 Environmental Protection Agency, California State Motor Vehicle Pollution Control 

Standards; Request for Waiver of Federal Preemption; Opportunity for Public Hearing, 72 Fed. 

Reg. 21260 (Apr. 30, 2007). 

13 Environmental Protection Agency, California State Motor Vehicle Pollution Control 

Standards; Notice of Decision Denying a Waiver of Clean Air Act Preemption for California's 

2009 and Subsequent Model Year Greenhouse Gas Emission Standards for New Motor Vehicles, 

73 Fed. Reg. 12156, 12157 (Mar. 6, 2008). 

4 
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On December 19,2007, Administrator Johnson annmmced that he had "found that 

California does not have a 'need to meet compelling and extraordinary conditions"' and that he 

had decided to deny California's waiver request. 14 In an unusual departure from agency practice, 

the Administrator announced this decision without releasing a decision document explaining the 

legal basis for the decision. The formal legal justification for the decision was not released until 

March 6, 2008, when Administrator Johnson wrote in the Federal Register: 

I do not believe section 209(b)(l)(B) was intended to allow California to promulgate state 

standards for emissions from new motor vehicles designed to address global climate 

change problems; nor, in the alternative, do I believe that the effects of climate change in 

California are compelling and extraordinary compared to the effects in the rest of the 

country.15 

B. The Committee's Investigation 

Upon learning of Administrator Johnson's decision to deny the waiver, Chairman 

Waxman announced that the Committee would be investigating "how and why this decision was 

made. "16 On December 20, 2007, Chairman W axrnan wrote to Administrator Johnson 

requesting documents relating to the California waiver request. 17 

EPA initially resisted producing many documents to the Committee. As a result, 

Chairman Waxman issued subpoenas to compel production of documents on three occasions. 

Chairman Waxman issued two subpoenas to require production of documents that the Committee 

staff had reviewed but that EPA had refused to produce. 18 After the issuance of the subpoenas, 

these documents were provided to the Committee. 

14 Letter to Arnold Schwarzenegger, Governor of California, from Stephen L. Johnson, 

Administrator, U.S. EPA (Dec. 19, 2007). 

15 Environmental Protection Agency, California State Motor Vehicle Pollution Control 

Standards; Notice of Decision Denying a Waiver of Clean Air Act Preemption for California's 

2009 and Subsequent Model Year Greenhouse Gas Emission Standards for New Motor Vehicles, 

73 Fed. Reg. 12156, 12157 (Mar. 6, 2008). 

16 Committee on Oversight and Government Reform, Chairman Waxman's Statement on 

EPA Denial of California Waiver Request (Dec. 19, 2007) (online at www.oversight.house.gov/ 

story.asp?ID=1672). 

17 Letter from Chairman Henry A. Waxman to Stephen Johnson, Administrator, U.S. 

EPA (Dec. 20, 2007). 

18 Committee on Oversight and Government Reform, Subpoena to Stephen L. Johnson 

(Feb. 8, 2008) (compelling production offive sets of briefing slides for the Administrator). 

Committee on Oversight and Government Reform, Subpoena to Stephen L. Johnson (Mar. 13, 

2008) (compelling production of 196 internal EPA documents). 

5 
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On April 8, 2008, Chairman Waxman issued a third subpoena for the production of 

communications between EPA and persons in the White House. 19 EPA continues to withhold 

some documents from the Committee that are responsive to this subpoena. The White House 

Counsel's office has informed Committee staff that EPA possesses 32 documents that evidence 

telephone calls or meetings in the White House involving at least one high-ranking EPA official 

and at least one Assistant to the President or the President himself. The White House Counsel's 

office has described these documents as "indicative of deliberations at the very highest level of 

government. "

20 

In total, the Committee has received over 27,000 pages of documents from EPA. The 

Committee staff has also conducted transcribed interviews and a deposition of eight EPA 

officials. 21 

ll. CHRONOLOGY OF EVENTS 

Previously undisclosed internal EPA documents and the Committee's interviews and 

deposition with key EPA staff provide new insights into the decisionmaking process inside EPA. 

These documents, interviews, and deposition show that EPA's career staff who worked on the 

California waiver petition all supported granting the request; that Administrator Johnson 

supported the position of his career staff at least in part; and that there was an unexpected 

reversal in the Administrator's position after he communicated with White House officials. This 

section of the memorandum describes key milestones in the administrative process. 

A. The June 15, 2007, Briefing 

Over a period of several months, EPA staff held a series of briefings for the 

Administrator on the California waiver request. One of the earlier briefings occurred on June 15, 

2007. 

19 Committee on Oversight and Government Reform, Subpoena to Stephen L. Johnson 

(Apr. 8, 2008). 

20 Meeting between Committee on Oversight and Government Reform staff, EPA staff, 

and White House staff (Apr. 22, 2008). 

21 Committee on Oversight and Government Reform, Transcript oflnterview of Karl 

Simon (Jan. 30, 2008); Committee on Oversight and Government Reform, Transcript of 

Interview of Dina Washburn Kruger (Jan. 31, 2008); Committee on Oversight and Government 

Reform, Transcript oflnterview of Brian McLean (Feb. 5, 2008); Committee on Oversight and 

Government Reform, Transcript of Interview of Robert David Brenner (Feb. 6, 2008); 

Committee on Oversight and Government Reform, Transcript of Interview of Margo Oge (Feb. 

7, 2008); Committee on Oversight and Government Reform, Transcript of Interview of Maureen 

Delaney (Feb. 11, 2008); Committee on Oversight and Government Reform, Transcript of 

Interview of Benjamin DeAngelo (Feb. 12, 2008); Committee on Oversight and Government 

Reform, Transcript ofDeposition of Jason Burnett (May 15, 2008). 

6 
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At the June 15 briefing, Administrator Johnson reviewed a series of "briefing slides" 

prepared by the staff. One briefing slide presented a review of the public comments submitted.to 

EPA. The slide included the May 2007 "initial assessment" of the Office of Transportation and 

Air Quality (OTAQ) career staff: "CAmet the statutory criteria for a waiver."22 It further noted 

that the staff's ''interim assessment based on waiver record to date also supports this 

conclusion."23 

According to an internal EPA e-mail, Bob Meyers, the Principal Deputy Assistant 

Administrator for the Office of Air and Radiation, was upset that this staff view was included in 

the briefmg slides. Mr. Meyers's chiefofstaffwrote: 

We had a fairly significant slip up in preparing Friday's GHG briefing for the 

Administrator. It's the very last bullet on page 6- "OTAQ's initial assessment." ... 

Bob was not happy when he read that page during the briefing .... I wanted to let 

someone in OT AQ know about this so we can permanently delete the offending language 

and not have it arise again.24 

B. The September 12, 2007, Brief'mg 

By August 2007, the staff was refining its assessment of the merits of California's reques1 

and developing decision options for the Administrator. This culminated in a briefing to the 

Administrator on September 12, 2007. 

On August 29, Karl Simon, the director of the OT AQ division primarily responsible for 

the waiver, advised his staff to drop the denial option from the list of options presented in draft 

briefing slides. Regarding the options, he wrote: "I think we should also do something to 

indicate that not all of these are equal and that the most defensible position remains a clean 

approva1."25 The draft slides included the following statement: 

OTAQ and OGC [Office of General Counsel] are reviewing these options from legal, 

technical, and waiver precedent perspective and other options may fall out of our review. 

Not all of these options are defensible and clearest option is to grant the waiver.26 

The next day, a new draft of the slides was circulated. This draft included an explicit 

staff assessment: 

22 Environmental Protection Agency, President's GHG Rule: Status Briefing (June 15, 

2007). 

23 ld 

24 E-mail from Don Zinger to Karl Simon and Sarah Dunham (June 18, 2007; 5:36p.m.). 

25 E-mail from Karl Simon to David Dickinson (Aug. 29, 2007; 9:51 p.m.). 

26 Attachment to e-mail from Ben DeAngelo to Rona Birnbaum, at 40 (Aug. 30, 2007; 

5:50p.m.). 

7 
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From a legal, technical and policy perspective (and waiver precedence) CA has made the 

requisite protectiveness determination and those opposing the waiver have not clearly 

demonstrated that any of the section 209(b) criteria have been met. A waiver should be 

granted.27 

As the slides were being reviewed, the EPA General Counsel, Roger Martella, requested 

that that they "be focused on our options beyond granting."28 The next day, the career staff 

attorney followed this direction by preparing a new briefmg document entitled, "California GHG 

Waiver: Arguments Against Granting.'t29 When he sent the document to Mary Ann Poirier, the 

Deputy General Counsel, he explained: "It is meant to be stripped-down and frank, to give 

Roger my best advice on the pros and cons of options short of a full grant. ,.:Jo Before describing 

the options other than a full grant of the waiver request, the slides included a strongly-worded 

"caveat" page, which stated: 

After review of the docket and precedent, we don't believe there are any good arguments 

against granting the waiver. All of the arguments discussed here are likely to lose in 

court if we are sued. The arguments here are the best of a bad lot, going from most to 

least plausible.31 

The option of denying the waiver based on California's lack of compelling and 

extraordinary conditions is then presented as the third of six options. An apparently later version 

of the caveat page is phrased similarly: 

After review of the docket and precedent, we believe the arguments against granting the 

waiver have high to very high legal vulnerability. All of the arguments discussed here 

would more likely than not lose in court if the~ are challenged. The arguments here are 

presented in decreasing order of defensibility. 2 

On September 11, Karl Simon sent the latest version of the briefing slides to Bob Meyers, 

the acting head of the air office. Mr. Simon explained: "I modified the options discussion a bit 

to better reflect the current state of analysis and OGC's views.''33 The options slide did not 

include a denial option and began with the following statement: 

27 Attachment to e-mail from David Dickinson to Karl Simon, eta!., at 3 (Aug. 31, 2007; 

4:17p.m.). 

28 E-mail from Michael Horowitz to Mary Ann Poirier (Sept. 4, 2007; 4:36p.m.). 

29 Attachment to e-mail from Michael Horowitz to Mary Ann Poirier (Sept. 5, 2007; I :36 

p.m.). 

30 E-mail from Michael Horowitz to Mary Ann Poirier (Sept. 5, 2007; 1:36 p.m.). 

31 Attachment to e-mail from Michael Horowitz to Mary Ann Poirier (Sept. 5, 2007; I :36 

p.m.). 

32 Environmental Protection Agency, California GHG Waiver: Arguments Against 

Granting (undated). 

33 E-mail from Karl Simon to Karen Orehowsky (Sept. II, 2007; 8:I8 a.m.). 

8 
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27172.638

OTAQ and OGC are reviewing these options from a legal, technical, and waiver 

precedent perspective and other options may fall in or out of our review. The clearest 

and most defensible option is to grant the waiver. The other options have high to very 

high vulnerability to legal challenge.34 

At this point, the briefmg slides also included a number of explicit "staff evaluations" 

regarding the compelling and extraordinary conditions criterion. For example, the staff found: 

• "CA continues to exhibit extraordinary ozone conditions. CA conditions, such as 

population and density, coastline, salt-water intrusion, wildfires, agricultural economy, 

snow pack and melt, etc, when aggregated, represent serious conditions on their own and 

when compared with other states."35 

• "The GHG standards are reasonably viewed as necessary to address both climate change 

and ozone conditions within the state."36 

• "Opponents have not met their burden of demonstrating that CARB's [California Air 

Resources Board] GHG program will not have an incremental benefit for both climate 

change and ozone conditions."37 

Evidence obtained by the Committee indicates that Mr. Meyers insisted on removing 

these staff evaluations from the briefing slides so that the information was only communicated to 

the Administrator orally. None of the staff evaluations regarding the compelling and 

extraordinary conditions or the legal defensibility of the various options available to the 

Administrator remained in the final slides that were presented to the Administrator on September 

12. 

The day the slides were sent to Mr. Meyers's office, Karl Simon sent an e-mail 

explaining that Mr. Meyers's assistant "is fixing the inclusion of staff evaluations. Note that Bob 

dropped two slides -the summary of the NERA report and the options summary page. I am 

pushing hack."38 Christopher Grundler, the Deputy Director of the Office of Transportation and 

Air Quality, replied: "what do you mean, 'fixing'? as in, deleting?"39 Mr. Grundler also asked: 

"Did you get direction NOT to convey staff evaluations or options?"40 Mr. Simon responded: 

34 Attachment to e-mail from Karl Simon to Karen Orehowsky, at 32 (Sept. 11, 2007; 

8:18a.m.). 

35 ld at 26. 

36 ld at 22. 

37 !d. at 24. 

38 E-mail from Karl Simon to Margo Oge, eta!. (Sept. 11, 2007; 1:03 p.m.). 

39 E-mail from Christopher Grundler to Karl Simon (Sept. 11, 2007; I :24 p.m.). 

40 E-mail from Christopher Grundler to Karl Simon (Sept. II, 2007; 11:22 p.m.). 
691 


27172.639

"yes, in a written form. we will be having the conversation though.'"'1 This understanding is 

reflected in Mr. Grundler's handwritten notes on the options slide presented to Mr. Meyers. 

Next to the OT AQ and OGC analysis, Mr. Grundler wrote: "Bob changes this.'"'2 And at the 

bottom of the page, he wrote: "Staff evaluation Bob deletes- Karl should take original to 

meeting with Steve verbally go over staff evaluation.'"'3 During her interview, Maureen 

Delaney, a career Program Analyst in the Office of Air and Radiation, confirmed that removing 

the staff evaluations from the slides was "a management-level decision" done at the ''political 

level.''44 

Despite the removal of the staff evaluations from the briefing slides, career EPA staff 

clearly communicated their professional assessment to the Administrator at the September 12 

briefing. Margo Oge, the Director of the Office of Transportation and Air Quality, told 

Committee staff: "verbally there was a staff evaluation ... that California has met that criteria. "

45 

When asked by Committee staff about the staff evaluations, Maureen Delaney explained: "I 

believe that they were spoken, even though they weren't included in the briefing, and they 

indicated generally that ... we did not have reason to deny the waiver.''46 

C. The September 20 and 21, 2007, Briefmg 

After the September 12 briefing, EPA staff began preparing slides for the next briefing 

with the Administrator on September 20 and 21. The purpose of this briefing was to present an 

in-depth analysis of the decision options available to the Administrator. 

On September 18, a career staff attorney in the Office of General Counsel transmitted his 

first draft of the options slides. The conclusions slide included the following analysis: 

• "Most defensible action is to grant waiver.'' 

• "Denial based on lack of need for standards to meet compelling and extraordinary 

conditions has high legal risk and is contrary with central tenets of prior EPA procedure 

and likely EPA statements defending its own GHG rule.''47 

41 E-mail from Karl Simon to Christopher Grundler (Sept. 12, 2007; 8:07a.m.). 

42 Christopher Grundler's notes on draft briefing slides (undated). 

43 Id. 

44 Committee on Oversight and Government Reform, Transcript of Interview of Maureen 

Delaney, at 11-12, 72-73 (Feb. 11, 2008). 

45 Committee on Oversight and Government Reform, Transcript of Interview of Margo 

Oge, at 43-44 (Feb. 7, 2008). 

46 Committee on Oversight and Government Reform, Transcript oflnterview of Maureen 

Delaney, at 13 (Feb. 11, 2008). 

47 Attachment to e-mail from Michael Horowitz to John Hannon, at 16 (Sept. 18, 2007; 

9:58a.m.). 

10 
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27172.640

The next version of the options slides did not include this conclusions slide, but did 

include legal analysis of the options. The slides stated that the option of granting the waiver was 

"consistent with past interpretation of statute, EPA practice case law, and the record."48 The 

slides also noted: ''we routinely grant CA waivers for standards more stringent than EPA 

standards. ""9 The document raised several "issues" regarding the denial option based on lack of 

compelling and extraordinary conditions, including the observation that denial would be 

"[i]nconsistent with precedent saying we look at vehicle program as a whole, not individual 

standards. " 50 The slides also explained that such a denial ''would undercut EPA arguments 

regarding benefits of federal [greenhouse gas emissions control] program in terms of ozone and 

general climate change benefits."51 After Bob Meyers and Associate Deputy Administrator 

Jason Burnett edited the slides, much of this legal analysis was removed and did not appear in 

the final briefing slides for Administrator Johnson. 52 

Nevertheless, EPA career staff made it clear to the Administrator at the options briefing 

that they believed that the statutory criteria for granting the waiver request had been met. Karl 

Simon told the Committee the EPA career staff view "[t]hat the waiver criteria were met" was 

discussed at the briefing. 5

3 Several participants of the meeting told Committee staff that Mr. 

Johnson ended the briefing by going around the room and asking the staff for their individual 

recommendations. Ben DeAngelo, a Senior Analyst for Climate Change, explained: 

"Administrator Johnson essentiallyJ<>lled the room on what people's final options were about 

granting or not granting a waiver." 

According to the five EPA employees who attended the meeting and were interviewed by 

Committee staff; every EPA employee who expressed an opinion supported granting the waiver 

in full or in part. A partial grant of the waiver would involve granting the waiver for the first two 

to three model years starting with the 2009 model year. No one in the meeting advised the 

Administrator to deny the waiver. Karl Simon told Committee staff that "most people took the 

48 Attachment to e-mail from Michael Horowitz to Roger Martella, et a!., at 6 (Sept. 19, 

2007; 9:34a.m.). 

49 Id at 17. 

50 Id at 16. 

51 ld at 17. 

52 E-mail from Michael Horowitz to Allison Starmann (Sept. 19, 2007; 10:53 p.m.); Email from Michael Horowitz to Mary Ann Poirier (Sept. 24, 2007; 2:29p.m.). 

53 Committee on Oversight and Government Reform, Transcript of Interview of Karl 

Simon, at 33 (Jan. 30, 2008). 

54 Committee on Oversight and Government Reform, Transcript of Interview of 

Benjamin DeAngelo, at 19 (Feb. 12, 2008). 

11 
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27172.641

opportunity" to offer a recommendation that "approval or partial approval would be the way to 

go."55 Margo Oge explained: 

What I recall is that all the attendants, with the exception of Bob Meyers who was not 

asked to express his opinion ... were either supporting granting the full waiver or 

granting partial waiver. 56 

Jason Burnett told Committee staff: "all EPA recommendations that I am aware of, 

whether they be staff or me or someone in a similar position, were to grant the waiver."57 

General Counsel Roger Martella also supported a partial granting of the waiver, although 

he said that he believed the agency could defend any of the options placed in front of the 

Administrator. 58 According to Mr. Burnett, Mr. Martella "stated that the legal risk was higher 

with denying the waiver and that the legal risk was lowest with granting the waiver."59 

This interview testimony is supported by written notes and summaries of the meeting. 

Karl Simon's handwritten notes indicate that the Administrator "polled everyone but BM [Bob 

Meyers] for recommendation- all supported at least 2B," a partial grant of the waiver.60 Ben 

DeAngelo's summary of the meeting stated: "OTAQ and OGC folks said granting the waiver 

straight-up is probably most defensible."61 Christopher Grundler's handwritten notes simply 

stated: "all agreed on grant~ waiver."62 A second note reads: "All attendees agree for full or 

partial granting the waiver." 

55 Committee on Oversight and Government Reform, Transcript of Interview of Karl 

Simon, at 82-83 (Jan. 30, 2008). 

56 Committee on Oversight and Government Reform, Transcript of Interview of Margo 

Oge, at 21-22 (Feb. 7, 2008). 

57 Committee on Oversight and Government Reform, Transcript of Deposition of Jason 

Burnett, at 129 (May 15, 2008). 

58 Committee on Oversight and Government Reform, Transcript oflnterview of Margo 

Oge, at 22 (Feb. 7, 2008). 

59 Committee on Oversight and Government Reform, Transcript of Deposition of Jason 

Burnett, at 23 (May 15, 2008). 

60 Handwritten notes of Karl Simon on California GHG Waiver: Options Briefing for the 

Administrator (Sept. 21, 2007). + 

61 E-mail from Ben DeAngelo to Dina Kruger (Sept. 21, 2007; 5:07p.m.). 

62 Handwritten notes of Christopher Grundler on California GHG Waiver: Options 

(undated). 

63 Id. 

12 
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D. The October 30, 2007, Briefmg 

After the options briefing, some EPA staff expected the Administrator to reach a decision 

soon.64 However, on October 9, Administrator Johnson called another meeting, during which he 

tasked the staff with providing additional information on a number of topics related to the 

waiver. The final briefmg for the Administrator involving career staff was held on October 30. 

The October 30 briefmg slides were intended to provide the Administrator with the information 

he had requested. 

According to the career staff interviewed by the Committee, the final briefing slides 

represented the professional views of EPA's technical and legal staff.65 The slides included the 

following conclusions: 

• "Fundamental circumstances of geographic, climatic, human and motor vehicle 

populations remain compelling and extraordinary (including ozone and PM [particulate 

matter]) and fit the GHG circumstances which will not only exacerbate the ozone 

conditions but also such conditions are highly vulnerable to climate change." 

• "The potential for climate change to exacerbate California's unique tropospheric ozone 

problem is one element of California's compelling and extraordinary conditions. 

However, it is by no means the sole foundation for the compelling and extraordinary 

argument. In fact, climate change impacts on California's wildfire, water resource, and 

agricultural situation may be the state's greatest concerns." 

• "California exhibits a number of specific features that are somewhat unique and may be 

considered compelling and extraordinary with regard to both the need for mitigation 

actions and its potential vulnerability to climate change. " 66 

The briefing slides also contained legal analysis regarding the agency's litigation 

prospects if the waiver was granted or denied. The slide entitled "If We Grant" stated that EPA 

would face a "Likely Suit by Manufacturers" and that "EPA is almost certain to win such a 

suit.',67 The slide entitled "If We Deny" stated that EPA would face an "[a)lmost certain lawsuit 

64 See Committee on Oversight and Government Reform, Transcript of Interview of 

Benjamin DeAngelo (Feb. 12, 2008). 

65 Committee on Oversight and Government Reform, Transcript of Interview of Margo 

Oge, at 31 (Feb. 7, 2008); Committee on Oversight and Government Reform, Transcript of 

Interview of Benjamin DeAngelo, at 34, 39 (Feb. 12, 2008); Committee on Oversight and 

Government Reform, Transcript oflnterview of Karl Simon, at 72, 76, 153-154 (Jan. 30, 2008); 

Committee on Oversight and Government Reform, Transcript of Interview of Dina Kruger, at 26, 

31, 32 (Jan. 31, 2008); Committee on Oversight and Government Reform, Transcript of 

Interview of Brian McLean, at 29, 32 (Feb. 5, 2008). 

66 Environmental Protection Agency, Briefing for the Administrator: California's GHG 

Waiver Request: Follow-Up on Additional Questions (Oct. 30, 2007). 

67 Id 

13 
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27172.643

by California" and that "EPA's litigation risks are significantly higher than if a waiver is 

granted. ,68 

In earlier drafts of the briefing slides, the "If We Deny" slide included stronger language. 

An October 29 draft provided the following legal prognosis: "EPA likely to lose suit."69 

According to Karl Simon, at the October 29 pre-briefing with Bob Meyers, "there was some 

discussion on some of-the way to characterize the legal advice."70 Maureen Delaney told 

Committee staff: "the last statement on what would happen if California sued under a denial, 

that was changed, and I think changed the meaning somewhat."71 When asked whether the 

earlier draft slides better represented the views of the career staff, she responded: "lbat 

conclusion, yes."72 Ms. Delaney added: "It was a stronger statement in the previous- in the 

draft version.'' 73 

The evidence obtained by the Committee shows that EPA staff clearly informed 

Administrator Johnson that they believed the compelling and extraordinary conditions criterion 

was met. Margo Oge told Committee staff: 

When Ben presented this information to the Administrator and presented it to me, clearly, 

clearly what I am hearing is that California meets this extraordinary and compelling 

needs, the conditions .... 

If you read this whole document ... in its totality, you would walk away with the same 

impression that I walk away when I talked to the experts ... that California has met the 

criteria of compelling and extraordinary needs based upon these facts. And that is what 

Ben told the Administrator.74 

When asked by Committee staff whether there was "any question in your mind that this 

staff view that the waiver criteria were met was clearly communicated to Administrator 

68 /d. 

69 Attachment to e-mail from Betsy White to Jo Beth Banas, eta!. (Oct. 29, 2007; 3:30 

p.m.). 

7

° Committee on Oversight and Government Reform, Transcript of Interview of Karl 

Simon, at 68 (Jan. 30, 2008). 

71 Committee on Oversight and Government Reform, Transcript of Interview of Maureen 

Delaney, at25 (Feb. 11, 2008). 

72 Id 

73 /d. at 76. 

74 Committee on Oversight and Government Reform, Transcript of Interview of Margo 

Oge, at 60-61 (Feb. 7, 2008). 

14 
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27172.644

Johnson," Maureen Delaney replied: "Was there any doubt? No."75 In addition, Ben 

DeAngelo's summary of the meeting states: 

In addition to the argument that climate change may exacerbate CA's tropospheric ozone 

problem- for which CA has historically demonstrated compelling and extraordinary 

conditions - I think Johnson now better appreciates that there are additional conditions 

in CA that make them vulnerable to climate change. 76 

Similarly, Jason Burnett agreed that career staff"clearly communicate[ d) to the 

Administrator that they believed that the compelling and extraordinary conditions criterion was 

met."77 

During the October 30 briefing, career EPA staff explicitly told the Administrator that 

granting the waiver was the most legally defensible option, while a denial of the waiver would be 

unlikely to survive legal challenge. When asked by Committee staff whether he thought the 

options of granting, partially granting, or denying the waiver request were all legally defensible, 

Karl Simon replied: "I think it d~nds on your definition of 'legally defensible.' ... It would 

get you in the courthouse door."7

· He explained that the Administrator was told that the 

available options were "legally defensible" only in the sense that they "get you past rule 11 

sanctions" in federal court for raising a frivolous claim?9 Referring to a lawsuit challenging 

EPA's denial of the waiver request, Mr. Simon stated: "I think the odds are that we willlose."80 

Margo Oge also thought that the evidence before the Administrator all pointed toward 

granting the waiver. She told Committee staff: 

working on the waiver for the time that we had been working and looking at the 

legislative history, the precedent has been set by EPA approving the California waivers 

for the past 40 years ... my view was and continues to be, based on the Clean Air Act and 

all these factors, granting of the waiver was the most defensible way to proceed. 81 

75 Committee on Oversight and Government Reform, Transcript of Interview of Maureen 

Delaney, at 26 (Feb. II, 2008). 

76 E-mail from Ben DeAngelo to Brian McLean, eta!. (Oct. 31, 2007; 12:54 p.m.). 

77 Committee on Oversight and Government Reform, Transcript of Deposition of Jason 

Burnett, at 128 (May 15, 2008). 

78 Committee on Oversight and Government Reform, Transcript of Interview of Karl 

Simon, at 69 (Jan. 30, 2008). 

79 Committee on Oversight and Government Reform, Transcript of Interview of Karl 

Simon, at 133 (Jan. 30, 2008) (''passed" in original transcript). 

8

° Committee on Oversight and Government Reform, Transcript of Interview of Karl 

Simon, at Ill (Jan. 30, 2008). 

81 Committee on Oversight and Government Reform, Transcript of Interview of Margo 

Oge, at 88-89 (Feb. 7, 2008). 

15 
697 


27172.645

Maureen Delaney agreed that "the thrust of the explanation to him [Administrator 

Johnson] was that if he denied the waiver, EPA would likely lose any subsequent lawsuit."82 

During her interview, she said: "I think, as we pointed out, some [options] were more likely to 

survive a litigation risk than others."83 Ms. Delaney added: "There are varying shades of what 

would be defensible .... Most people felt that a denial would be ... a significant litigation risk."84 

Ben DeAngelo confirmed that the legal jeopardls of a denial was fully explained to 

Administrator Johnson during the October 30 briefing. 5 When asked by Committee staff what 

conclusions about the legal defensibility of different options he drew from the October 30 

briefing, Mr. DeAngelo stated: "I had heard by this stage in the process now a number of times 

from the legal people that granting the waiver was, in their minds, most legally defensible and 

that was my takeaway."86 

According to Jason Burnett, the legal jeopardy ofa denial was communicated to the 

Administrator on a number of occasions. He told Committee staff that the legal judgment of 

General Counsel Roger Martella and his office was that "denying the waiver had very significant 

legal risk. "87 He explained: 

I believe that it was communicated in several fora, through this slide, verbally when these 

slides were presented to the Administrator, and in multiple meetings that we had, that 

Roger Martella, I, and others had, with the Administrator. 88 

E. The December 19,2007, Decision 

On December 19, 2007, Administrator Johnson sent a two-page letter to Governor Arnold 

Schwarzenegger of California announcing that he intended to deny the waiver petition. The 

stated basis for the denial was California's lack of compelling and extraordinary conditions. 

82 Committee on Oversight and Government Reform, Transcript of Interview of Maureen 

Delaney, at 28 (Feb. II, 2008). 

83 Committee on Oversight and Government Reform, Transcript of Interview of Maureen 

Delaney, at 93 (Feb. II, 2008). 

84 Committee on Oversight and Government Reform, Transcript of Interview of Maureen 

Delaney, at 94 (Feb. II, 2008). 

85 Committee on Oversight and Government Reform, Transcript of Interview of 

Benjamin DeAngelo, at 76-77 (Feb. 12, 2008). 

86 Committee on Oversight and Government Reform, Transcript oflnterview of 

Benjamin DeAngelo, at 77 (Feb. 12, 2008). 

87 Committee on Oversight and Government Reform, Transcript of Deposition of Jason 

Burnett, at 127 (May 15, 2008). 

88 ld at 127. 

16 
698 


27172.646

Career staff who had worked on the issue for months were swprised by the decision to 

deny the waiver because it did not appear to be supported by the record. When asked by 

Committee staff if he was swprised by the decision, Rob Brenner, the Director of Policy 

Analysis and Review, responded: 

Yes, I was swprised. I expected that it would probably be either a grant of the waiver or 

a partial waiver .... I felt that ... the anal;ses that had been put together seemed to point 

towards either a full or a partial waiver. 8 , 

Maureen Delaney told Committee staff that she also was swprised by the decision: 

"Personally, having been at the briefings, and it was contrary to the advice that I thought that he 

had received from the staff, so I was swprised."90 She explained: "it was difficult to see how he 

arrived at that decision, given the information that had been provided and the consensus among 

the staff ... It seemed like a difficult place to get to.'m 

In his deposition, Mr. Burnett told the Committee that the Administrator's December 19 

decision was a reversal of the Administrator's prior position. According to Mr. Burnett, 

Administrator Johnson ''was very interested in a full grant of the waiver" in August and 

September.92 Mr. Burnett told the Committee that "at some point in the process," the 

Administrator then modified his view and believed thai a partial grant of the waiver "was the 

best course ofaction."93 Mr. Burnett explained: "the Administrator was interested in initially a 

full grant, and became interested in a partial grant, asked for me and others to explore ways of 

making a partial grant work.''94 Mr. Burnett added: "over the course of a period of months he 

certainly shifted his focus and his stated interests to me and others from a full grant to a partial 

grant.''9s 

According to Mr. Burnett, Administrator Johnson's preference for a full or partial grant 

of the waiver did not change until after he communicated with the White House about the matter. 

When asked by Committee staff''whether the Administrator communicated with the White 

House in between his preference to do a partial grant and the ultimate decision" to deny the 

89 Committee on Oversight and Government Reform, Transcript oflnterview of Rob 

Brenner, at 32 (Feb. 6, 2008). 

90 Committee on Oversight and Government Reform, Transcript of Interview of Maureen 

Delaney, at 34 (Feb. 11, 2008). 

91 Committee on Oversight and Government Reform, Transcript of Interview of Maureen 

Delaney, at 63-64 (Feb. 11, 2008). 

92 Committee on Oversight and Government Reform, Transcript of Deposition of Jason 

Burnett, at 118 (May 15, 2008). 

93 Id at 119. 

94 Id at 123. 

95 ld at 139. 

17 
699 


27172.647

waiver, Mr. Burnett responded: "I believe the answer is yes. "

96 When asked "after his 

communications with the White House, did he still support granting the waiver in part," Mr. 

Burnett answered: "He ultimately decided to deny the waiver. "

97 Mr. Burnett also affirmed that 

there was "White House input into the rationale in the December 19th letter."98 

At the time of the December 19decision to deny the California waiver, there were 

apparently no EPA employees or agency documents arguing for this decision. Five EPA staffMargo Oge, Karl Simon, Ben DeAngelo, Maureen Delaney, and Rob Brenner-told the 

Committee they were unaware of any EPA employees who espoused or agreed with the 

argument that California did not meet the compelling and extraordinary conditions criterion.99 

They also told the Committee that they were unaware of any pre-December 19 internal EPA 

documents recommendin¥t that the waiver be denied based upon a lack of compelling and 

extraordinary conditions. 00 On December 20, the day after Administrator Johnson announced 

his decision to deny California's waiver request, the most recent internal draft of the decision 

document was written as if the waiver was to be granted in fu11. 101 

F. The March 6, 2008, Federal Register Notice 

Typically when an EPA Administrator announces a final decision, the agency releases an 

analysis explaining the basis for the decision on the same day. This did not happen in the case of 

the denial of the California waiver. EPA did not release a formal legal justification for the denial 

until March 6, 2008, when the official decision document was published in the Federal Register. 

This decision document included a more detailed discussion of the rationale for denial put forth 

in the Administrator's December 19,2007, letter to Governor Schwarzenegger. The primary 

legal juStification offered by the Administrator was that Section 209 of the Clear~ Air Act was not 

96 Id at 60. 

97 Id at 120. 

98 Id at 140. 

99 Committee on Oversight and Government Reform, Transcript oflnterview of Margo 

Oge, at 95 (Feb. 7, 2008); Committee on Oversight and Government Reform, Transcript of 

Interview of Maureen Delaney, at 36 (Feb. 11, 2008); Committee on Oversight and Government 

Reform, Transcript of Interview of Karl Simon, at lOS (Jan. 30, 2008); Committee on Oversight 

and Government Reform, Transcript of Interview of Benjamin DeAngelo, at 87 (Feb. 12, 2008); 

Committee on Oversight and Government Reform, Transcript of Interview of Rob Brenner, at 36 

(Feb. 6, 2008). 

100 Committee on Oversight and Government Reform, Transcript of Interview of Karl 

Simon, at 112 (Jan. 30, 2008); Committee on Oversight and Government Reform, Tr~ript of 

Interview of Brian McLean, at 35 (Feb. 5, 2008); Committee on Oversight and Government 

Reform, Transcript oflnterview of Robert David Brenner, at 38 (Feb. 6, 2008); Committee on 

Oversight and Government Reform, Transcript of Interview of Maureen Delaney, at 37 (Feb. 11, 

2008); Committee on Oversight and Government Reform, Transcript of Interview of Benjamin 

DeAngelo, at 87 (Feb. 12, 2008). 

101 E-mail from David Dickinson to Michael Horowitz, eta!. (Dec. 20, 2007; 6:53 a.m.). 

18 
700 


27172.648

"intended to allow California to promulgate state standards for emissions from new motor 

vehicles designed to address global climate change problems." He also rejected the view that 

"the effects of climate change in California are compelling and extraordinary compared to the 

effects in the rest of the coWltry. 102 

ill. THE POSffiON OF THE WWTE HOUSE 

The record before the Committee-in particular the deposition testimony of Mr. Burnett 

-indicates that the White House played a decisive role in the rejection of the California motor 

vehicle standards. Before communicating with White House officials, Administrator Johnson 

supported the position of career EPA staff that the waiver should be granted. He reversed 

himself only after these communications. 

Little is known publicly about the White House position. According to press accoWlts, 

the CEOs of Ford and Chrysler met with Vice President Dick Cheney prior to the denial and 

urged the Administration to reject the waiver. 103 After Administrator Johnson annoWlced that 

the waiver would be denied, a White House spokesman said that the White House supported this 

decision. 104 

During the deposition of Mr. Burnett, Committee staff repeatedly asked about the White 

House role. In response, Mr. Burnett told the Committee that he had been instructed by EPA not 

to answer these questions. Based on the instructions from EPA, Mr. Burnett refused to answer: 

• With whom in the White House did Administrator Johnson communicate about the 

California waiver before it was denied?105 

• "Can you tell us the time at which that communication with the White House 

occurred?"106 

• "Will you tell us the substance of those communications?"107 

102 U.S. EPA, California State Motor Vehicle Pollution Control Standards; Notice of 

Decision Denying a Waiver of Clean Air Act Preemption for California's 2009 and Subsequent 

Model Year Greenhouse Gas Emission Standards for New Motor Vehicles, 73 Fed. Reg. 12156, 

12157 (Mar. 6, 2008). 

103 EPA blocks Calijfoel rules, Detroit News (Dec. 20, 2007). 

104 Press Gaggle by Tony Fratto, White House Office of the Press Secretary (Dec. 21, 

2007) (online at www. whitehouse.gov/news/releases/2007/12120071221-S.html). 

105 Committee on Oversight and Government Reform, Transcript of Deposition of Jason 

Burnett, at 58 (May 15, 2008). 

106 !d. at 60. 

to7 !d. at 61. 

19 
701 


27172.649

• "Do you know if the Administrator communicated or met with the President on this 

matter?"108 . 

• Did White House staff"ever communicate to you a preference or an expectation 

regarding the outcome of the California waiver?"109 

• With whom in the White House did you communicate about the California waived 10 

• "Can you tell us the reason that ... [the Administrator] told you his mind changed?"111 

In addition, as described above, EPA has withheld from the Committee documentary 

evidence of interactions between EPA and the White House about the California waiver before 

the denial decision was announced. The White House Counsel's office has informed Committee 

staff that EPA possesses 32 documents that evidence telephone calls or meetings in the White 

House involving at least one high-ranking EPA official and at least one Assistant to the President 

or the President himself. The White House Counsel's office has described these documents as 

"indicative of deliberations at the very highest level of government. "112 

IV. CONCLUSION 

The record before the Committee answers many questions about·what transpired within 

EPA prior to the denial of California's petition to regulate greenhouse gas emissions from motor 

vehicles. The record indicates that the California waiver had unanimous support among the 

career EPA staff and was backed at least in part by EPA Administrator Johnson. What the 

record does not answer, however, is why the California petition was denied given the strong 

support inside EPA. 

It appears that the White House played a significant role in the reversal of the EPA 

position. This raises questions about the basis for the White House actions. The Clean Air Act 

contains specific standards for considering California's petition. It would appear to be 

inconsistent with the President's constitutional obligation to faithfully execute the laws of the 

United States if the President or his advisors pressured Administrator Johnson to ignore the 

record before the agency for political or other inappropriate reasons. 

Additional investigation by the Committee will be required to assess the basis for the 

White House intervention in the decision. 

108 Id. at 61. 

109 Id at61. 

110 Id at 61. 

Ill Id at 123. 

112 Meeting between Oversight and Government Reform Committee staff, EPA staff, and 

White House staff (Apr. 22, 2008). 

20 
702 

Senator HARRIS. Will you commit, if confirmed, to follow the 

science and law, and heed the advice of career staff in the Department, and recognize and preserve California’s authority to issue its 

own new motor vehicle standards as it relates to emissions? 

Mr. WEHRUM. Senator, the provision that you refer to, in appropriate circumstances, certainly does allow California to implement 

its own motor vehicle standards, and my commitment to you would 

be to understand that provision as much as possible and implement 

it as faithfully as possible. 

Senator HARRIS. And are you familiar with the several decades 

of practice and court decisions that make it clear that the EPA 

should be deferential to California and only deny the waiver if the 

EPA could ‘‘affirmatively demonstrate that California, or any State, 

was arbitrary and capricious’’? 

Mr. WEHRUM. Senator, EPA has an obligation to review waiver 

requests and make a determination if they are adequate in light 

of the criteria set out in that provision, yes. 

Senator HARRIS. OK. And you are familiar with these decades of 

practice that have made that finding? 

Mr. WEHRUM. I can’t say I am familiar with every single waiver 

that has been issued, but I am familiar with the waiver process, 

Senator. 

Senator HARRIS. OK. I would urge you to become familiar with 

it, if confirmed. Thank you. 

Mr. Dourson, in my home State of California, the city of Santa 

Clarita has struggled with groundwater contamination from perchlorate. The toxic chemical is a byproduct of producing munitions 

and rocket fuel, and it affects the thyroid’s ability to regulate metabolism and guide a child’s development. 

In Santa Clarita, for more than 50 years, the Whittaker Bermite 

Corporation contaminated the soil and groundwater across a 1,000- 

acre site in the heart of the city. You, sir, were hired by companies 

that have used perchlorate, like Lockheed Martin and Boeing, to 

study this toxic chemical, and you rewarded them by marking that 

the safe level would be eight times higher than what the EPA said 

would be safe. 

In 2013 the EPA’s own independent Science Advisory Board 

asked you to recuse yourself from perchlorate matters because of 

this conflict of interest. 

Can you commit to this Committee that you will recuse yourself 

from any EPA decision having to do with perchlorate? 

Mr. DOURSON. Again, Senator, I am going to rely on guidance 

from EPA ethics officials to determine any issues for which I need 

to be recused. 

Senator HARRIS. Sir, you profess to be a professional. And you 

must be, then, aware that professional standards as it relates to 

ethics, and as my colleague has mentioned, also moral standards, 

would demand that we are aware of not only an appearance of conflict, but actual conflict. And if we are to be leaders, it would suggest to me that you, as a leader, as you say, in this field, would 

understand the importance of making the decision yourself, instead 

of waiting for someone else to tell you that you should recuse yourself from these matters. 

703 

Are you going to wait for permission from the ethics to exercise 

your discretion as it relates to other matters? Do you believe you 

possess discretion in this position, if confirmed? 

Mr. DOURSON. Senator, as I stated in my opening statement, I 

commit my mind, body, and spirit to protecting the public health, 

if confirmed, in this organization, the Office of Chemical Safety and 

Pollution Prevention. The staff is very talented. I would be humbled and honored to serve with them, but ultimately protect the 

public health, including those sensitive members of the population. 

Senator HARRIS. Are you aware that, if confirmed, you would 

have the discretion to recuse yourself and would not have to be ordered to do so by anyone? 

Mr. DOURSON. Again, I can depend on EPA ethics officials to advise me in that capacity. 

Senator HARRIS. Are you aware that you would have the discretion to make that decision, sir? 

Mr. DOURSON. I would, again, defer to EPA ethics officials to advise me in that capacity. 

Senator HARRIS. I have nothing else. 

Senator BARRASSO. Thank you, Senator Harris. 

Senator WICKER. Thank you, Mr. Chairman. 

Dr. Dourson, am I pronouncing your name right? 

Mr. DOURSON. Yes, sir. 

Senator WICKER. My first question deals with the Federal Insecticide, Fungicide, and Rodenticide Act, FIFRA. As we all know, pesticide policy in the United States is supposed to involve a balancing 

act between the potential hazards of a pesticide and the benefits 

of the product based on real world impacts. Pesticides can poison 

you, can hurt people. But without pesticides, we would not be able 

to supply the world with food and fiber as we do; hence, the balancing act with real world facts under FIFRA. 

There is a feeling that, under the Obama administration, decisions were made by EPA that were beginning to resemble not what 

we call facts on the ground, but a precautionary approach to regulation, where regulatory action was taken to prevent theoretical 

risks, unproven risks. So would you please comment on that issue, 

and will you tell the Committee about your commitment to science 

based risk assessment of pesticides under FIFRA? 

Mr. DOURSON. Senator, my career, including more than a decade 

as an EPA scientist, focused on protecting public health by developing, reviewing, and communicating risk assessment values done 

in an impartial and objective and transparent way. If confirmed, I 

commit myself to you and this Committee, and to the American 

people, to continue in that effort. 

Senator WICKER. Well, OK. Do you have any insights to give to 

the members of the Committee about my concern or the concerns 

of people like me that there has been too far of a move toward precautionary regulation and prevention of theoretical and unproven 

risks, rather than facts on the ground? 

Mr. DOURSON. The area that I study and work in, and the area 

of the Office of Chemical Safety and Pollution Protection risk assessment is preventive medicine. In some regards, it is precautionary. However, there have been tendencies in certain cases 

to be additionally precautionary, more protective than needed, and 

704 

you are correct, Senator, in those particular situations you might 

have an erosion of this balancing act within FIFRA. 

If confirmed, I will go in and work with the talented staff of the 

Office of Pesticide Programs and bring impartiality to it, or maybe 

maintain that balance if it is already there, so that you can be assured and the American people can be assured that FIFRA is regulated in the way it is intended to be regulated as a balance between 

risk and benefit. 

Senator WICKER. OK. 

Well, let me move, then, to Federal procurement of wood and 

guidelines from the Federal Government and from EPA in that regard. 

I can tell you that folks in my State of Mississippi feel that the 

Federal Government has unduly discriminated against domestic 

lumber and domestic wood production by this adherence to one 

form of certification from the Forest Stewardship Council, ignoring 

and to the detriment of other initiatives such as the Sustainable 

Forestry Initiative, SFI, or the American Tree Farm System, ATFS. 

What do you know about that, and do you have any information 

to share with the Committee about guidelines issued for purchasing lumber and wood discriminating against domestically produced wood? 

Mr. DOURSON. Senator, I am not familiar with that particular 

issue, but if confirmed, I would be more than happy to work with 

you individually or this Committee and appropriate Chemical Safety and Pollution Prevention staff to make sure that such discrimination is at least understood, and if not appropriate, to be removed. 

Senator WICKER. And I will note, Mr. Chair, that I asked Administrator Pruitt essentially the same thing when he was here in January. 

So, doctor, I would just like to make sure, will you commit to 

working with me and your colleagues at EPA to fix this flawed policy so that EPA promotes the use of all domestic forest products in 

its purchasing policy? 

Mr. DOURSON. I would be happy to work with you, Senator, on 

that. 

Senator WICKER. Now, Mr. Chairman, my time has expired. I understand we are going to have a second round. If I could squeeze 

in a quick question, I could be out of your hair. 

Senator BARRASSO. Senator Gillibrand, you are next. Are you OK 

with him doing that? 

Senator WICKER. I am sure she will love the question. 

[Laughter.] 

Senator WICKER. Because I was going to ask Dr. Dourson, Mr. 

Leopold, Mr. Ross, and Mr. Wehrum did they agree or disagree 

that Waters of the United States and the Clean Power Plan involved a reach beyond the authority granted the EPA by Congress. 

And we will start with Mr. Wehrum down here. 

Mr. WEHRUM. Well, I can speak to the Clean Power Plan, Senator, and I think I would just refer to the action of the U.S. Supreme Court, which, in an unprecedented move, stayed implementation of the Clean Power Plan even before the D.C. Circuit had 

rendered a decision on the underlying litigation. The Court has 

never taken an action like that in its history, and I think it says 

705 

a lot about that Court’s perspective on the legal viability of the 

CPP. 

Mr. ROSS. Senator, I can speak to the Waters of the United 

States litigation, and I will defer to the same thing. There are two 

Federal courts who have taken the extraordinary step of staying 

implementation of a rule both on procedural and substantive concerns. So I think the courts have sent the message as to whether 

or not there are some legal infirmities there. 

Mr. LEOPOLD. Senator, I will echo the comments of my colleagues 

here and that courts have taken extraordinary steps that are unprecedented in staying both of those regulatory actions. Thank you. 

Mr. DOURSON. Senator, as a scientist and not a lawyer, I think 

I will withhold comment about the legalities of this particular 

thing. As a member of EPA’s Science Advisory Board, however, this 

rule came through us, and I had some comments on that and some 

scientific risk issues that were raised during the meeting. But 

again, I have no comments on the legality. 

Senator WICKER. Are those a matter of public record? 

Mr. DOURSON. Yes, Senator, they are. 

Senator WICKER. OK. Could you make those available to the 

Committee? 

Mr. DOURSON. Sure. Absolutely. 

Senator WICKER. Thank you. 

And let the record reflect that I owe Senator Gillibrand at least 

my 3 minutes. 

Senator GILLIBRAND. I will hold you to that. 

Senator BARRASSO. Senator Gillibrand, thank you for your patience. Thank you. Appreciate it. 

Senator GILLIBRAND. Thank you, Mr. Chairman. 

Mr. Dourson, today, in the audience, are New Yorkers whose 

lives have been personally impacted by the chemical PFOA: Michael Hickey, Laureen Hackett, Gwyneth Young, and Lee Marby. 

They live in the village of Hoosick Falls, New York, and the town 

of Petersburg, New York, two neighboring communities that together are going through a gut wrenching experience of discovering 

that their drinking water, the water that they drink, the water 

they give their children, the water they cook in, the water they 

bathe in, is contaminated by PFOA. Michael Hickey has lost his father to kidney cancer, and they have family members, friends, and 

neighbors affected by illnesses that are known to be linked to 

PFOA. 

These families are so frightened. I live so close to where they 

live. I can’t imagine what it would be like to live and not know if 

the water that your children are being bathed in is safe; if they are 

going to get cancer when they are 25; if they are ever going to be 

able to have kids. Their lives are so affected by the decisions that 

you have made, and I don’t think you recognize when you are hired 

by a company, when you are hired by the DuPonts of the world, 

when you are hired by the Monsantos of the world, you are being 

asked to change how governments, how leaders look at these risks 

and whether they say it is safe or not. 

We have lived through this. After 9/11 the EPA said the air was 

safe. Do you know how many people in their 40s and 50s and 60s 

have died of cancers you would not see in people who are younger 

706 

than 80? Because you have such a responsibility. You are no longer 

being paid for your opinions. You are here as a public servant. 

Your job is to serve the people sitting behind you. Your job is to 

look at their children in the same way you would look at your own 

children or any other person you love. And the decisions that you 

are going to make will affect hundreds and hundreds of more children just like them. 

Now, you have refused to answer the question that my colleagues 

have asked you, if you would recuse yourself. If I was you, I would 

recuse myself over and over again if I was paid for a determination 

that in many instances were multiples, hundred times, thousand 

times more than what the EPA has recommended. 

Now, I can take you through the drill. Do you believe that PFOA 

has been linked to cancer, including kidney cancer? 

Mr. DOURSON. I believe the scientific studies associated with 

PFOA indicates that it is linked to some kinds of cancers. 

Senator GILLIBRAND. Concerns about PFOA are not unique to upstate New York, but your organization, TERA, was hired to assess 

the safety of PFOA in West Virginia in 2002. We know that DuPont manufactures PFOA in Parkersburg, West Virginia, and I understand they paid you for that assessment, correct? 

Mr. DOURSON. The State of West Virginia hired us to do that assessment, Senator. 

Senator GILLIBRAND. Was DuPont involved at all? 

Mr. DOURSON. Senator, I don’t know about where the State of 

West Virginia got its money. 

Senator GILLIBRAND. Did TERA recommend, in a risk assessment, that water with PFOA levels of up to 150 parts per billion 

was safe to drink? 

Mr. DOURSON. No, Senator, TERA did not; that was a collection 

of 10 individuals, 5 of them government agents, government employees, 4 of them U.S. EPA that made a consensus decision on 

that. 

Senator GILLIBRAND. But it was 150 parts per billion. 

Mr. DOURSON. The science at the time indicated in a consensus 

manner of all the scientists at the table that that was the appropriate level to base it on. 

Senator GILLIBRAND. Did you know that DuPont had an internal 

recommendation guideline of 1 part per billion at the time? 

Mr. DOURSON. Our understanding at the time was the 1 part per 

billion was a placeholder; it wasn’t based on a full reading of the 

science. They were waiting for the science panel to do it. 

Senator GILLIBRAND. Do you know that EPA has a health advisory level of .07 parts per billion? 

Mr. DOURSON. The science has progressed, significantly advanced 

since the time of 2004, and the new science indicates a lower level. 

Senator GILLIBRAND. Do you know that in Hoosick Falls they 

have found contamination at .66 parts per billion, which at the 

level you determined would save 150 parts per billion is 228 times 

higher than the parts per billion that is actually occurring today 

in Hoosick Falls? 

Mr. DOURSON. Well, again, the science has progressed since the 

time of the consensus decision of the 10-member panel in 2004. I 

am not aware of the specific—— 

707 

Senator GILLIBRAND. So here is my fundamental question. 

Mr. DOURSON [continuing]. Exposure in that particular location, 

however. 

Senator GILLIBRAND. In the job you are about to take, will you 

commit that you will maintain the .07 parts per billion standard? 

Mr. DOURSON. Senator, if confirmed, I will commit to protecting 

the American public and its most vulnerable members using the 

best science and working with the talented people of the Office of 

Chemical Safety and Pollution Prevention. We will bring the best 

science forward; we will be transparent; we will be collaborative. I 

commit to that. 

Senator GILLIBRAND. Mr. Chairman, can I just ask unanimous 

consent to submit for the record two articles from West Virginia, 

a West Virginia news source? The first quotes a watchdog group 

formed to ensure companies remain liable for pollution for damages 

of PFOA, and the article concluded Michael Dourson spent his career helping chemical companies cover up deadly chemical contamination, and he was directly complicit in the PFOA contamination 

crisis that seriously harmed thousands of West Virginians and 

Ohioans. This nomination is a classic example of the fox guarding 

the hen house. 

Senator BARRASSO. Without objection. 

[The referenced information follows:] 

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27172.650

EPA nominee once helped chemical 

Doun;on says C8 levels are acc:ep1tal:llle 

JESS MANCINI 

jmancin.i@newsandsentind.~mn 

PARKERSBURG- The president's nominee to run a regulatory agency ofthe Environmental Protection 

Agency is being questioned for his closeness to the chemical industry. 

Michael Dourson was nominated by President Trump to head the Office of Chemk.a! Safety and Pollution 

Prevention. Dourson has been a consultant for the chemical industry and once said the acceptable level for 

C8, or PFDA, should be higher than the EPA limit. 

Based on that, "he's not qualified," said Dr. Paul Brooks, whose company organi7.ed the collection of health 

data from 70,000 poople in the Mid-Ohio Valley and led the C8 science panel to conclude there's a 

po.•;sible link between the compound once used to make Teflon at the Washington Works in Wood County 

and six diseases in humans. 

"You don't want the fox guarding the hen house," Brooks said. 

Dourson's nomination V.'l\s originally scheduled to be heard Sept, 20 by the U.S. Senate's Committee on 

Environment and Public Works. It was postponed, possibly to Wednesday. 

Sen. Shelley Moore Capito, R-W.Va., is a member ofthe committee. Capito spokesman Ashley Berrang 

said the senator would like the opportunity to discuss Dourson's background at a nomination hearing 

before announcing her position on his nomination. 

Jeffrey Dugas of Keep Your Promises DuPont, a watchdog group formed to make sure DuPont remains 

financial liable for the CS damages, also used the fox and hen house analogy. 

"Michael Dow'Son spent his career helping chemical companies cover up deadly chemical 

contamination, and he was directly comp/icit in the C-8 contamination crisis that has seriously harmed 
709 


27172.651

thousands West ll1rgmw and Ohio, .. Dugas said. nomination is a clw;sic example <1( the fox 

guarding the hen house and an to everyone in the mid-Ohio Valley." 

More scientists and n.'searchers are concluding that the acceptable level of exposure to C8 is zero and the 

acceptable concentration in the blood serum should be zero, Brooks said. 

It's unlikely, in the event Dourson is confirmed by the Senate, the EPA would raise the acceptable longtenn exposure levels from parts per hil!ion, said.TI1e state ofVennont, for example, supports a 

of .01 ppb, Brooks said. 

"1 don't think there's any chance the FPA will ever raise it up,"he said. 

"If Mike Dourson is confirmed, the environmental health of ever·y child in the country tossed 

a;ide, as he will almost certainly continue his workfmm inside EPA to greenwash chemicals and 

pesticides to protect the prqfits of the companies that make them, Ken O:Jok, president of the 

Environmental Working Group. "Handing the keys EPA:~ qfjice of Chemical SafetiJ and Pollution 

Prevention to Dourson, who has spent a career opposing both, mako:s about as much sense as letting the 

CEO of Philip Morris nm the American Lung Association" 

The group points out that in 2000, the state of West Virginia hired Dourson and Toxieology Excellence for 

Risk Assessment - TERA- which WdS paid for by DuPont, to determine "safe"' level for C8 in drinking 

wdter. In 2002. the group reported the safe was 150 ppb, 150 time' greater than what DuPont 

scientists detennin<xl14 years earlier. 

"Some of us are very disturbed by Pr'esident Tnanp:, nomination of Michael Dourson to lead chemical 

safety at EPA," said Harry Deitzler, a lead attomey in the original C8laws11its in Wood County that led to 

the creation of the science panel and an attorney in the federal dass action snits settled this year with 

DuPont 

"The New York Times, Today and the Associated Press have all pointed out that Dow·son has a long 

track record q{downplaying concerns about toxic chemicals,"' Deitzler said. "Specifically thai includes 

work that Dow·sDn has done on PFtM. Dourson has warked on dozen~ of chemicaLs ji;r dozens of 

chemical industry clients and lws always found reoson to suggest looser standards for his clients· 

products." 

lOCAL NEWS 

Ohio Valley Ski Club plans for winter fun 

Glenville State College preps Homecoming 

GLE~'Vl UE - 'fhe Glenville Slate College Homecoming Cmmnittee has plauntx'i activities for ;,i.ud.enL't. fat-'1llty, ~i.nff, " 
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27172.652

EPA nominee has ties to \l./V chemical contr(rversies l PoliLic.~ I wvgue!tcmaiLeom 

D 

--

EPA nominee has ties to WV chemical controversies 

By Ken Ward Jr. Staff writer 19 hrs ago (".) 

Toxicologist Michael Oourson 

A longtime industry consultant picked by President Donald Trump 

to head the U.S. Environmental Protection Agency's chemical 

safety arm was involved in several major public health 

controversies in West Virginia. 

Toxicologist Michael Dourson was involved in the long saga over 

DuPont Co.'s contamination of Mid-Ohio Valley drinking water 

supplies with the chemical C8. Dourson also was a contractor for 

a team that then-Gov. Earl Ray Tomblin appointed to investigate 

!he potential impacts of the January 2014 Elk River chemical spill. 

The Trump administration nominated Dourson to be assistant 

administrator in charge of EPA's Office of Chemical Safety and 

Pollution Prevention. 

Dourson has most recently been a professor in the Risk Science 

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EPA nominee has ties to WV chemica! controversies I Politics 1 wvgazettemail.com 

Center at the University of Cincinnati. 

Dourson worked for EPA for about 15 years, and then formed a 

nonprofit consulting firm, Toxicology Excellence for Risk 

Assessment, or TERA, that The New York Times has said 

"became a line of first defense for companies facing health and 

safety challenges from the EPA." 

The EPA~ "widespread praise" for the Dourson 

nomination, but environmental groups are strongly opposing his 

confirmation by the Senate. 

"Dourson has made a career as a hired gun for the chemical 

industry, helping clients play down concerns over toxic chemicals 

with known and potentially severe health effects,"~ 

Environmental Defense Fund, one of the groups opposing 

Dourson. "If confirmed to the top job at the EPA's Office of 

Chemical Safety and Pollution Prevention, Dourson will be 

regulating his old industry friends." 

Dourson is scheduled to face questioning Wednesday from 

members of the Senate Environment and Public Works 

Committee during a confirmation hearing. 

In West Virginia in the early 2000s, Dourson and TERA ~ 

brought jn by the state Department of Envjroomental Protection to 

help the government respond to concerns about the 

contamination of drinking water supplies with the toxic chemical 

CB from DuPont's plant near Parkersburg. 

The committee Dourson and his firm worked with came up with a 

standard that set the safe level of CB in drinking water at 150 

parts per billion. Citizen groups~ at the time the number 

was wrong, and that the committee's work was slanted toward 

DuPont. 

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Later, Dourson testified for DuPont in a trial that resulted in a $1 6 

million judgment against the company. That case and several 

others last to a $671 million settlement with thousands of 

In 2014, Dourson was brought in by the West Virginia Testing 

Assessment Project, an effort created by the Tomblin 

administration to assess the contamination ofthe Kanawha Valley 

region's drinking water system following the Jan. 9, 2014, 

chemical spill at Freedom Industries. 

The WVT AP review concluded that a "screening level" for drinking 

water, set by the U.S. Centers for Disease Control and 

Prevention, had allowed higher levels of contamination than it 

should have. 

But a health-effects panel chaired by Dourson also pulled some 

~ in its discussion of the potential impact of the spills, not 

making its criticism of the CDC especially clear to residents. Also, 

Dourson was crilicized for not making clear from the outset any 

potential confiicts of interest involved with his previous work for 

companies that made chemicals that were spilled. 

Reach Ken Ward Jr. at kward@wvgazettemail.com, 304-348-1702 or follow 

@kenwardjr on Twitter. 

https://mvw:wvgazettemail.comi .. Jepa~nominee·has·ties·tO·"-"'··chemical·oontroversies/anicle_8f661436·ldfe.52fc.b2ed·57fn47d8945a.htm!{!0/3!2017 9:46:13 AM] 
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Senator BARRASSO. Thank you, Senator Gillibrand. Thank you 

for your patience. 

Senator Cardin. 

Senator CARDIN. I am not exactly sure how to begin on this, but 

I think I will start with Mr. Leopold. I have a major concern for 

the safety of the people in Baltimore. On September the 18th of 

this year a cloud of chlorosulfonic acid leaked through a valve at 

Solvay Industry plant in Baltimore. I don’t know if you are familiar 

with that or not. 

Thousands of my constituents were told to shelter in place for 

several hours that morning and early afternoon over fear of their 

health and safety. It is my understanding that this bill is colorless, 

and it is very difficult to know its presence other than the effect 

it has on your skin and respiratory tract. It can be fatal. It is extremely dangerous. 

And I would like to get your understanding of what role you will 

play as counsel in dealing with protecting the people of Baltimore 

and this nation on this issue. On June 9th Administrator Pruitt 

signed a final order to further delay the effective date of the RMP 

Rule amendment, known as the Chemical Accident Safety Rule, for 

20 months, until February 19th, 2019. 

So I want to get some of your views as to what role you are going 

to play on implementing the laws of this country through regulations so that we are not bearing in Baltimore this type of safety 

condition. This is not hypothetical; it happened just a few weeks 

ago. 

So how do you see your role, if confirmed, in using the enforcement of our laws to protect the public health of the people of this 

country? 

Mr. LEOPOLD. Thank you, Senator. I think the general counsel’s 

role on this issue—and my concerns are certainly with the people 

of Baltimore and those who have experienced releases of chemicals—I think the role of the general counsel of the EPA is to approach this issue as it would any legal issue; to look at the statutes, the regulation the EPA administers. 

And in this case EPA has emergency response authority, which 

in an Office of Emergency Response, which it could activate. I am 

not privy to any details about what is occurring in the Agency at 

the moment, but—— 

Senator CARDIN. Emergency response is one thing. Preventing 

this is something else. The delay of the rule is delaying protection. 

Do you believe that you would have a role in making sure that we 

get timely action taken on these types of rules? 

Mr. LEOPOLD. Well, I think the General Counsel’s Office, again, 

the role is to advise the program offices and the Administrator on 

their authority, and if the Agency has discretion, we would advise, 

the discretion and the statutory bounds in which the Agency has 

to operate. Again, that is the role of the counsel, but certainly my 

commitment, as is the Administrator’s, is to the rule of law. And 

if the law requires a substance to be regulated, I would advise of 

that, Senator. 

Senator CARDIN. And of course, delay is denying the regulation 

of the law. So they may have discretion of delay, but do you see 

714 

an obligation to make sure that the laws that we passed are carried out? 

Mr. LEOPOLD. Absolutely, Senator. The obligation of the EPA is 

to implement the laws that are passed by Congress. In certain instances, the Agency has discretion on when to exercise that discretion, and in other instances statutes are very specific about when 

the Agency has to take action. 

Senator CARDIN. I hear you. I would like to get a greater comfort 

that public safety is the reason why we pass these laws. There may 

be discretion on delay, but delay can cost people lives, so there 

needs to be a sense of urgency on public health. 

Mr. Ross, quickly, if I might. We have had several discussions 

about the Chesapeake Bay Program and the fact that it is a unique 

program; it is local governments up, we have all the stakeholders 

working together. Mr. Pruitt, in his confirmation hearing, said very 

nice things about the Chesapeake Bay, so I assume you are going 

to say nice things about the Chesapeake Bay Program. 

Mr. ROSS. Yes. Thank you for the question. A couple months ago 

I had the distinct pleasure of driving 16 hours across country with 

the little ones back here to go from Wisconsin. We dropped our 

children off at a YMCA camp along the Chesapeake Bay in Maryland, in your State, and my wife and I continued out to the Delaware shore in your State, Senator Carper. So I care very deeply 

about where my kids play and swim, and the water quality, and 

I think the Bay is a treasure. 

Senator CARDIN. Let me just point out that this Committee just 

reauthorized the Chesapeake Bay Program, the Federal role in the 

Chesapeake Bay Program by unanimous vote, and we authorized 

it at a higher level than the current appropriation levels. It is a 

clear signal that this program is supported, and for the benefit of 

your children, we hope that you will be a strong advocate to help 

us as one of the stakeholders, because without the Federal Government’s significant role in this, it is hard for the other stakeholders 

to work together, because Federal participation is the glue in a program that is really popular among the six States and the District 

of Columbia and the stakeholders. So we will hold you to helping 

your children preserve this great heritage. 

Thank you. 

Senator BARRASSO. Thank you, Senator Cardin. 

Mr. Ross, having served both the State of Wyoming and Wisconsin, I think you have an immediate understanding and an intimate understanding of many of the different types of water issues 

faced by States across the country. Senator Wicker raised some 

questions about the Waters of the U.S. Could you please just explain to the Committee how you intend to work with western 

States to solve some of the water and water scarcity issues faced 

in Wyoming and elsewhere? 

Mr. ROSS. Yes. You put your finger on it. I have worked in California, and I studied in Vermont, I have worked in Wisconsin, I 

spent time in DC; I spent a lot of time in Wyoming, and what I 

have learned is that each region, each State has unique challenges; 

and the issues out west are both water quality and water quantity, 

and that is a really difficult intersection. 

715 

And there are some amazing folks, including in Wyoming, the 

State engineer, the director of the Department of Environmental 

Quality, they are subject matter experts that understand the issues 

as well as anyone. My job is to go learn from them and to make 

sure that the Federal Government works collaboratively with the 

States to protect the resources. 

Senator BARRASSO. And Mr. Baran, I wanted to just follow up. 

The National Environmental Policy Act, NEPA, that requires agencies to prepare an environmental impact statement. They have to 

do it for every major Federal action. Well, at the NRC major Federal actions can include the issuance of licenses, license amendments. NEPA requires an agency to provide notice and to take public comments as it prepares an environmental impact statement. 

But in contrast to many Federal agencies, the NRC has voluntarily decided to take steps beyond those required by NEPA. Specifically, the NRC allows parties to challenge the NRC’s environmental impact statement at its evidentiary hearing on security and 

safety measures. So, recently what we have seen are anti-nuclear 

activists. They have argued that if new information is presented at 

the hearing, then the NRC can’t supplement its environmental impact statement. 

Instead, these activists are arguing that the NRC has to go back 

and rewrite the entire environmental impact statement before 

issuing a license or license amendment. So, if the NRC has already 

issued a license, these activists argue that the NRC has to then vacate and suspend a license that has already been issued. 

A bipartisan majority of the NRC Commissioners has repeatedly 

rejected this argument by the extremists, but you are the only 

Commissioner who agrees with these anti-nuclear activists, the 

only one. So, the issue is now before a Federal appeals court. So, 

if these activists succeed, it is going to add significant delays, I 

think, to any NRC licensing processes. This is going to make nuclear energy much more expensive to produce, and in some ways 

could potentially jeopardize safety. 

So, is it still your position—I know how you voted, but is it still 

your position that if new information is presented at NRC’s evidentiary hearings, that the staff must rewrite the environmental 

impact statement before the NRC issues a license or license 

amendment? And if the NRC has already issued a license or license 

amendment, they must then vacate or suspend the license or the 

license amendment? 

Mr. BARAN. Well, my concern is a little bit more specific than 

that. In the cases I think you are citing, the issue there was that 

the NRC staff, as you mentioned, made a licensing decision on the 

basis of an environmental review that our administrative law 

judges, the agency’s administrative law judges later found to be inadequate. So that is the key factor there. 

My concern is that at the point we make a decision, when the 

agency issues a license, at that point we should do so on the basis 

of an adequate NEPA review. In my view, in the cases you mentioned, that did not happen. And as you mentioned, this question 

is now pending before the D.C. Circuit Court of Appeals, which will 

hold arguments on it next week. 

Senator BARRASSO. Thank you. 

716 

Senator Carper. 

Senator CARPER. Thanks, Mr. Chairman. 

I think this is a question for Bill Wehrum. Virtually every major 

clean air regulation that you helped to craft during the Bush administration has been thrown out, I am told, thrown out by Federal 

courts. Twenty-seven times the courts found that you failed to protect public health as directed by the law. All of the failed regulations you worked on created greater uncertainty for businesses and 

left the life of those that are most vulnerable at risk. 

When you left the EPA in 2007, I am sure you reflected on your 

time at the Agency in different ways, but one of the ways, the only 

one we are aware of, is really captured in the following quote from 

you, and I am going to read what the poster over my head says. 

It is put in juxtaposition to what Mr. Leopold said earlier in his 

testimony, and I think it was heartfelt, in his opening statement 

about a commitment, sort of a moral commitment to clean air, 

water, and so forth. 

I was out of the room when Mr. Ross invoked the verse for the 

beauty of the earth to talk about his commitment, and the juxtaposition of those two statements and what I am about to quote 

here from you just could not be stronger. Your quote is saying ‘‘I 

am a much better lawyer now than when I first joined the Agency. 

To really get to know how the Agency works and how it ticks, I 

think that is very valuable. I have expanded my capabilities, which 

will hopefully allow me to be effective in generating business and 

clients.’’ 

Since then you have represented industry 31 times in lawsuits 

that I am aware of, against EPA, arguing for weaker air toxic mercury and climate protections. Would you just take a minute and tell 

us why the American people should believe that you will be impartial in making decisions when it comes to protecting public health 

over the interest of the industries that you spent many years representing? 

Mr. WEHRUM. I would love to, Senator. Thank you. First of all, 

with regard to the cases you cited and also the quote that you provided, both of them are tip of the iceberg situations. With regard 

to the cases, what gets litigated in the D.C. circuit is a very, very 

small fraction of what gets done in the Office of Air and Radiation, 

so I think it is a misrepresentation of my experience at EPA previously to say that that somehow is an indicator that I am not committed to faithfully implementing the law and committed to protecting human health and the environment, so I think that is not 

representative. 

Senator CARPER. Let me just follow up, if I could. I am particularly concerned about your legal efforts against the Obama administration’s mercury and air toxic rule for power plants. You argued 

in court that EPA has not proven that it is appropriate to regulate 

mercury and air toxic power plant emissions, despite the fact that 

most utilities are meeting the rule’s deadlines and health benefits 

are being realized faster than predicted. 

Administrator Pruitt is reviewing the rule, and you made it clear 

you in our private meeting that you will not recuse yourself from 

working on this issue. If the mercury and air toxic rule is revoked, 

how is that good for public health? And if the rule is revoked, will 

717 

power plants stop running pollution control technology they have 

already bought, paid for, and installed, and how is that good for 

ratepayers? 

Mr. WEHRUM. Well, Senator, I think a point you are trying to 

make is rule of law is important, and there is no better example 

than this particular standard. It went all the way up to the U.S. 

Supreme Court. The U.S. Supreme Court said that EPA made a 

fundamental flaw in deciding whether to implement this regulation 

because it did not consider cost in making the threshold judgment 

as to whether power plants should be regulated as part of the 

Clean Air Act. 

That question is still an open question before U.S. EPA. The 

Obama administration implemented a rule to address that court 

finding, but the litigation is still pending, and I believe has now 

been stayed, and that is an issue that we will have to take up if 

I am confirmed. 

Senator CARPER. My time is almost expired, so I will ask you to 

hold it there. Thank you for that response. 

Mr. Chairman, I ask unanimous consent to submit four cases 

where Mr. Wehrum represented oil interests against biofuel, biodiesel, and renewable fuel standard regulations. These cases show 

or suggest that Mr. Wehrum should be very familiar with renewable fuel standard and flexibility given to the Administrator to implement the RFS. I make that unanimous consent request. 

Senator BARRASSO. Without objection. 

[The referenced information follows:] 

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Wehrum Cases Related to Biofuels/RFS 

National Chicken Council, eta!. v. EPA (D.C. Circuit Court of Appeals) (10-1107, 

consolidated with 10-1108,11-1030, ll-1089,and 11-1110) 

Wehrum represented National Chicken Council, National Meat Association, and 

National Turkey Federation in challenging EPA's "Regulation of Fuels and Fuel 

Additives: Changes to Renewable Fuel Standard Program." (75 FR 14670) 

Grocery Manufacturers Association v. EPA (D.C. Circuit Court of Appeals) (10-1380, 

consolidated with I 0-1414, Il-l 002, 11-1046, Il-l 072, and 11-1 086) 

Wehrum represented Grocery Manufacturers Association, American Petroleum 

Institute, and other industry groups, in challenging EPA's "Partial Grant and Partial 

Denial of Clean Air Act Waiver Application Submitted by Growth Energy to Increase 

the Allowable Ethanol Content of Gasoline to 15 Percent; Decision of the 

Administrator." (75 FR 68094) 

American Petroleum Institute v. EPA (D.C. Circuit Court of Appeals) (ll-1344,consolidated 

with 11-1334) 

Wehrum represented API in petition for review of EPA's "Regulation To Mitigate the 

Misfueling of Vehicles and Engines With Gasoline Containing Greater Than Ten 

Volume Percent Ethanol and Modifications to the Reformulated and Conventional 

Gasoline Programs." (76 FR 44406) 

Minnesota Auto. Dealers Ass'n v. Stine, No. 15-2045,2016 WL 5660420 (D. Minn. Sept. 

29, 2016). 

Wehrum represented a coalition of oil, gas and vehicle manufacturers 

against Minnesota state officials who were "connected to the 

implementation and enforcement of the Minnesota Mandate," a state 

law requiring diesel fuel sold to consumers in Minnesota to contain a 

specific percentage of biodiesel, alleging that the Mandate conflicted 

with the RFS, and therefore was preempted by the Supremacy Clause 

of the U.S. Constitution. Jd. at* I, 4. The court sided with 

Minnesota. Here is the case: http://blogs2.law.columbia.edu/climatechange-liti gation/wp-content/u p 1 oads/ sites/ 16/ casedocuments/20 16/20160929 docket-15-cv-02045 memorandumopinion-and-order-l.pdf 
719 

Senator BARRASSO. Thank you, Senator Carper. 

Senator CARPER. And if I could, just one more unanimous consent. I would like to ask unanimous consent to submit for the 

record two L.A. Times articles from 2004. These articles report two 

instances where Mr. Wehrum ignored the EPA career staff and inserted industry language from his former law firm, Latham & Watkins, into two different rules dealing with formaldehyde and mercury emissions. Both professions ended up failing in court. For the 

mercury rule, the L.A. Times reported that, ‘‘Several complete 

paragraphs were lifted from three memos provided by Latham & 

Watkins, a national law firm whose clients include large coal-fired 

utility plants.’’ 

I ask unanimous consent. 

Senator BARRASSO. Without objection. 

[The referenced information follows:] 

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EPA Relied on Industry for Plywood PlM! Polluuon Rule -lanmes 

Cos Angrks [imrs , 1 1 

-BacktoOriginalArticle 

The Nation 

EPA Relied on Industry for Plywood Plant Pollution Rule 

May 21, 2004 j Alan C. Miller and Tom Hamburger 1 Times Staff Writers 

WASHINGTDN- Pushing aside new scientific studies of possible health risks, the Environmental Protection Agency approved an air pollution regulation this 

year that could save the wood products industry hundreds of millions of dollars. 

In doing so, the agency relied on a risk assessment generated by a chemical industry-funded think tank, and a novel legal approach recommended by a timber 

industry lawyer. The regulation was ushered through the agency by senior officials with previous ties to the timber and chemical industries. 

The officials say they advocate a balanced approach to environmental regulation that weighs costs as \..-ell as benefits. Their critics say science and public 

health are losing out. 

'This rulemaking veers radically from standard scientific and regulatory practices," said David Michaels, an epidemiologist who was assistant Energy secretary 

for environment, safety and health in the Clinton administration. Others say it may violate the Clean Air Act. 

The regulation addresses emissions of formaldehyde, a chemical used by plywood manufacturers and other industries. Exposure to formaldehyde may cause 

cancer and lead to nausea aud eye, throat and skin irritation. At the time the regulation was being drafted, the National Cancer Institute and the National 

Institute of Occupational Safety and Health disclosed new studies showing that exposure to formaldehyde might also canse leukemia in humans. 

The EPA rule, signed in February, did not mention the possible link to leukemia. Instead, it adopted a standard for exposure based on a cancer risk model 

developed by the Chemical Industry Institute of Toxicology. That assessment is about 10,000 times less stringent than the level previously used by the EPA in 

:letting general standards for formaldehyde exposure. 

Many scientists considered the earlier EPA risk level to be outdated; Canada, for example, used the chemical institute model to help set its formaldehyde 

standard in 2000. But the accuracy of that model in predicting human risk was a source of debate even before the new leukemia studies. 

Citing such concerns, a California scientific advisory panel voted unanimously this week to reject a formaldehyde industry request to reconsider the state's risk 

assessment of the toxic gas. Panel members said the chemical institute's model needed further development and validation. 

The new EPA rule also breaks legal ground in the application of the 1990 Clean Air Act amendments. 

At that time, Congress required industry to reduce emissions of toxic pollutants to levels that amid be achieved by the best available technology. But it 

permitted the EPA to spare entire categories of po1lution sources from tough controls if all posed less than a one--in-a~million cancer risk As the wood 

products regulation was being considered, it was clear the industry could not meet that test. Instead, the EPA created a new category of "low-risk" plants, 

putting the agency in the role of overseeing, plant by plant, which facilities endangered the public. 

The rule initially exempts eight wood products plants from controls on formaldehyde and other emissions. Ultimately, 147 or more of the 223 facilities 

nationwide could avoid the pollution-control requirements. The exemptions will save the industry as much as $66 million annually for about 10 years in 

potential emission control costs. 

The idea of identifying low-risk plants was suggested to the EPA by a lawyer at the firm of Latham & Watkins, which represents timber interests. 

The EPA's top air poJlution regulator, Jeffrey R. Holmstead, embraced the concept. He was already familiar with it. A former lawyer at Latham & Watkins 

himself, he had represented one of the nation's largest plywood producers and other companies seeking to limit pollution regulation. 

'Jhe basic approach was something that I had been thinking about for a number of years," said Holmstead, assistant EPA administrator for air and radiation. 

He also backed the EPA's use of the scientific data from the institute funded by the American chemical industry, another former client. 

At the White House, Ho\mstead fouud an ally in John D. Graham, regulatory chief of the Office of Management and Budget. He had established the respected 

Harvard Center for Risk Analysis, which received funding from some of the companies that pushed the new EPA regulation. Graham came to OMB vowing to 

set new standards for cost-benefit analysis, transparency and reliance on sound science in regulatory decisions. 

"Public health should be the regulator's first priority," Graham said in a written response to questions. "However, when the health risks are speculative, it is 

OMB's job to ask whether the regulation will be good for consumers, workers and businesses. Consumers pay for burdensome regulations in the form of higher 

prices for homes and products while American jobs are placed at risk." 

Some agency veterans say the EPA's approach departs from past practices under both political parties. 

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EPA Reh<1d on Industry for Plywood Plllllt Pollution Rule· latiJTies 

"EPA decisions now have a consistent pattern: disregard for inconvenient facts, a tilt toward industl)', and a penchant for secrecy," said Eric Schaeffer, a 

longtime EPA enforcement officia] who resigned in protest in 2002 and now beads the Environmental Integrity Project, a watchdog group. 

The Proposal 

In early 2002, the EPA was under court order to write regulations governing formaldehyde emissions at wood products facilities. Tb.e deadline was Feb. 27, 

2004. 

Formaldehyde is a naturally occurring chemical released when wood, tobacco and other organic substances burn. It is best known as the key ingredient in 

embalming fluid; its foul smell is familiar to anyone who dissected frogs in biology clru;s. It is used most frequently as a binding agent in pressed~wood 

products, furniture, flooring and chemical and household manufacturing. 

Although it is classified as a probable human carcinogen, the lack of crystal-dear links benveen exposure and increased cancer rates has long made regulation 

controversial. 

On Jan. 14, 2002, EPA staffers joined Holmstead in hL~ fifth-floor conference room to meet with a lobbyist for the American Forest & Paper Assn. and the 

group's Washington lawyer to discuss the upcoming rule-making. Such .sessions are routine at the EPA, ·where regulators and industry experts exchange 

scientific data and legal theories. 

But some staffers found this gathering remarkable. 

The forest product8lobbyist, Timothy Hunt, was an old acquaintance ofHolmstead's. William Wehrum, the air office's general colmsel, had represented 

timber intere1>1:s as well. The forest association's lawyer, Claudia M. O'Brien, had been a law partner ofHolmstead's and Wehrurn's at Latham & Watkins. 

Hunt and O'Brien were repre<ienting a politically well-connected industry. During the 2ooo election cycle, timber company employees and their families 

donated $8.3 million to federal candidates and committees, 83% of it to Republicans, according to the Center for Responsive Politics, a nonpartisan research 

organization. 

O'Brien presented proposals to spare low-risk plywood, particleboard and other plants from strict emission controls. She noted that such facilities were often 

situated in isolated areas, any hann from their emissions was debatable and, in some cases, the risk to the public appeared low. In addition, the expense of 

adding new controls to the plants, which the industry said could reach $1 billion, might make them \-'lllnerable to foreign competition. 

Reopening the Debate 

To some EPA staffers, this seemed like reopening a debate Congress had tried to resolve in 1990. In the 20 years after the passage of the 1970 Clean Air Act, 

the EPA bad been able to regulate only a handful of toxic substances because the agency became bogged down in disputes over how to measure heaJth risks. As 

a result, Congress amended the act in 1990 to require that all large industrial plants reduce emissions of 189 substances using the best available technology as 

their standard. 

But Holmstead was enthusiastic. Before reviewing the proposal with his own legal and technical staff, he declared, "We're going to do this," recalled one staffer 

who was there. 

In a recent interview, Holmstead said he didn't remember the meeting, but added, "I'm sure I would have expressed interest in pursuing that." 

He added: "Different people around town had been thinking for a while that it would be good if individual facilities conld make a showing that they pose no 

risk to the community. In that case, why would you require them to speud a lot of money" to red nee emissions? 

Throughout his career, Holmstead has sought to scale back environmental regulation ofbusine<ls and represented corporate clients seeking to minimize the 

effect of air pollution laws. 

As an associate White House counsel during the George H.W. Bush administration, he worked with Vice President Dan Quayle's Competitiveness Council, 

which pushed to reduce environmental and other regulation. 

After leaving government, he joined Latham & Watkins, where he represented chemical, semiconductor and other clients on environmental policy issues. 

In 1996, he worked with colleagues representing Georgia Pacific in a $35-million settlement with the EPA and Justice Department over aUeged Clean Air Act 

violations. The firm later was among those backing the proposal to exempt low-risk timber-product plants from formaldehyde controls. 

Federa] conflict~of-interest rules bar appointees from working on particular matters, such as contracts, grants or claims, that will have a financial effect on the 

appointee or his family. This aJso applies to matters involving a former employer for one year from the appointee's departure date. But rule-making, which has 

a broad effect, is exempted from this prohibition 

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EPA Rehed on !mlusrry for Plywood Plant Pollution Rule- !atimes 

"I meet with hundreds of outside groups representing a wide variety of interests, and it hardly seems right to penali:<:e" past associates "by not allowing them to 

meet with me," Holmstead said. "It would be very hard to get people who are knowledgeable and qualified to do these jobs if they are unable to talk to people 

with whom they had affiliations in the private sector." 

Graham, too, had past connections to the industries seeking to limit the regulation of furmaldehyde. His office at OMB reviews and approves all new federal 

regulations. 

He had testified on behalf of an association of paper companies, including Georgia Pacific, before the Maine Board of Environmental Protection in a 1992 

hearing on setting a risk level for carcinogenic pollutants. In addition, the timber company donated to Graham's Harvard Center for Risk Analysis in 1991, 

1992, 1995 and 1998. A spokesman said Georgia Pacific's donations were each for no more than $s,ooo. 

The chemical industry's trade association contributed annually to Graham's risk center from 1994 to 1997, and in 1999 and 2001. The center relies on 

government and foundations as well as a wide range of industry for its funding. 

Graham's prior financial ties were reviewed by OMB's ethics counsel when Graham took office and he was not "required to recuse himself from any issues," a 

spokesman said. 

As the proposed rule worked its way through the EPA, career attorneys advised Holmstead that the exemption ran counter to the 1990 Clean Air Act 

amendments. A confidential March 2003 memo from a lawyer in the general counsel's office highlighted its legal vulnerability. 

The proposal "results in a regulatory approach equivalent to the one Congress specifically rejected" in 1990, said the memo, obtained from sources outside the 

agency. "EPA would have a difficult time articulating any rational basis to defend such a .. scheme." 

Holmstead acknowledged the issue was debated by EPA lawyers. 

"At the end of the day, the agency determined it was something we did have the authority to do," he said. 

That's not the way architects of the 1990 legislation see it 

"I don't have any doubt but that is a way to get around the policy which we worked hard to achieve," said former Sen. David F. Durenberger {R-Minn.). Rep. 

Henry A. Waxman (D-LosAngeles) declared the timber products exemption "directly contrary to our intent" 

The rule has also prompted objections from state regulators. 

"It's a serious concern," said Bill Becker, executive diret•tor of two national organizations of state and local air pollution control officials. "We learned between 

1970 and 1990 that a risk-based approach is totally ineffective in regulating taxies. The analytical tools are not sophisticated enough today to make that 

determinatiou with confidence." 

Meanwhile, as the EPA neared its deadline for approving the wood produt1s regulation, the federal research institutes had updated two of the largest studies of 

formaldehyde toxkity ever conducted on human subjects. The National Cancer Institute study, published in November 2003, showed that 25,000 workers 

exposed to formaldehyde had an increased risk ofleukemia. 

A separate study of 10,000 workers by the National Institute of Occupational Safety and Health also found an elevated leukemia risk, but at different exposure 

levels. This assessment was posted on the in.<:titute's website in early 2004 and published in March. 

Conversely, a third study of about 14,000 workers in England published in November 2003 found no such risk. 

The authors of the U.S. studies said their work only suggested a link to leukemia, contained seemingly contradictory evidence and didn't explain how 

formaldehyde might trigger cancer in internal organs. But there was widespread agreement that the findings provided new reason for concern. 

Studies Back Old Level 

An internal EPA caJculation showed that taking the new studies into consideration would keep the formaldehyde risk assessment close to the long-standing 

EPA level. Some staffers contended the agency should wait before finalizing a rule. 

As a practical matter, if the EPA went plant-by-plant using its old risk level, about 90 facilities could he exempt from formaldehyde controls. But if the lower 

chemical institute assessment were employed, an additional 57 plants could qualify for the exemption. 

The Chemical Industry Institute ofToxico]ogy, a private, nonprofit research organization, changed its name in 2000 to the CIIT Centers for Health Research. 

Chemical companies provide most of the institute's funding, although it also receives federal grants and industry contracts. 

In an e-mail to colleagues, Peter W. Preuss, who directs the EPA's National Center for Environmental Assessment, said he had "never been comfortable" with 

the chemical institute formaldehyde risk number or with calling it the "best available science." He is overseeing EPA's own assessment of formaldehyde risk. 

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And the World Health Organization's cancer research agency had called a meeting for early June to consider the new leukemia findings. 

California's Scientific Review Panel on Toxic Air Contaminants cited the upcoming leukemia studies in mid-2003 when it postponed an industry request to 

adopt a more permissive formaldehyde standard. After further review, the pane}, which advises the state's Air Resources Board, voted 6-o Wednesday to 

recommend against reopening its risk assessment. 

Panel chairman John Froines determined the case for reconsideration, including the chemical institute model, was "not ready for prime time," a spokesman 

said. And a leading state toxicologirttold the panel any reassessment should include the new cancer institute study. 

In contrast, EPA leaders deeided to complete the federal rule based on the chemical institute science. They said they felt compelled by the court order to sign 

the new rule by the end of February. Extensions are frequently granted, but EPA did not seek one. 

If the EPA's evaluation offormaldehyde risk finds merit in the leukemia studies, adnrinistration officials say, the risk assessment could be readily revised. But 

legal and regulatory experts say the rule has so many untested provisions that such a change would invite lawsuits that could take years to resolve. 

"The question is: Are you going to effectively throw away all the work that's been done ... and say we always have to err on the side of any possible 

uncertainty?" Holmstead said. "At the end of the day, we have to make decisions based on the best available science." 

Many scientists, regulatory law experts and environmentalists insist the EPA should have taken the new human research studies into account when it did its 

risk assessment. The industry and others counter that unresolved que:.tions about the studies made it premature to use them as the basis for regulation. 

'The public should not assume a cause-and-effect relationship when only an association is suggested," said Betsy Natz, executive- director of the Formaldehyde 

Council Inc., a trade group. 

David Coggon, a British epidemiologist who did the 2003 study that found no increased level of leukemia, nonetheless said of the new American research: 

"The data are an extremely useful contribution to onr knowledge about the potential human carcinogenicity .. ,, Although I believe the risk of leukemia-- if 

there is one-- is low, I would expect regulators to take account of all the relevant scientific evidence." 

At the Office of Management and Budget, Graham said he agreed with the EPA's decision to proceed after his scientists reviewed the new studies and "found 

that the results are conflicting and difficult to interpret." 

In editing the new rule, Graham's office and senior EPA officials made only passing reference to the new scientific studies and rejected any specific discussion 

of them. The 503-page document contains no mention of a link to leukemia. 

Researcher Robin Cochran and staff writer Ashleigh Collins contributed to this report. 

il:os Angela; lt"'tmeS Copyright 2017 Los Angeles Times Index by Keyword I Imle.xbyDale I Privacy Policy j TermsofService 

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Mercury Em1sswns Rule Geared to Beoelit !ndusuy, Staff= Say. Jatuncs 

Cos Angdts Q:'itnrs " " , u, ,, , 

-BacktoOriginalArticle 

The Nation 

Mercury Emissions Rule Geared to Benefit Industry, Staffers Say 

Buffeted by complaints, EPA Administrator Michael Leavitt calls for additional analysis. 

March 16, 2004 I Tom Hamburger and Alan C. Miller I Times Staff Writers 

WASHINGTON - Political appointees in the Environmental Protection Agency bypassed agency professional staff and a federal advisory panel last year to 

craft a rule on mercury emissions preferred by the industry and the White House, several longtime EPA officials say. 

nte EPA staffers say they were told not to undertake the normal scientific and economic studies called for under a standing executive order. At the same time, 

the proposal to regulate mercury emissions from CQa]-burning power plants was written using key language provided by utility lobbyists. 

The Bush administration has said that the proposed rule would cut mercury emissious by 70% in the next 15 years, and is tied to the president's "Clear Skies" 

initiative. Critics say it would delay reductions in mercury levels for decades at a risk to public health, while saving the power and coal industries billions of 

dollars. 

Studies designed to address such questions are the ones that were not conducted. 

EPA veterans say they cannot recall another instance when the agency's technical experts were cut out of developing a major regulatory proposal. 

The administration chose a proeess "that would support the conclusion they wanted to reach," said John A. Paul, a Republican environmental regulator from 

Ohio who co-chaired the EPA-appointed advisory panel. 

He said its 21 months of work on mercury was ignored. 

"There is a politicization of the work of the agency that l have not seen before," said Bruce C. Builleit, who served in major federal environmental po!>ts for 

two decades. He retired in December as director of the EPA's Air Enforcement Division, partly because he felt enforcement was stymied. "A political agenda is 

driving the agency's output, rather than analysis and science," he said, 

Russell E. Train, a Republican who headed the EPA during the Nixon and Ford administrations, said: "I think it is outrageous. The agency has strayed from its 

mission in the past three years." 

Buffeted by complaints about the mercury proposal from both within and outside the agency, EPA Administrator Michael 0. Leavitt in recent days has called 

for additional analysis. EPA staffers say they have been asked to suggest possible comparative studies for the agency to run, much like the analysis that, they 

say, they were ordered not to conduct last year. 

"The process is not complete nor is the analysis," Leavitt said in an interview Monday. "I want it done well and I want it done right. And I want it done in a wa.y 

that will maximize the level of reductions" based on the available technology. 

Leavitt noted that while the EPA expressed a clear preference for a more flexible, market-driven plan, its proposed mercury rule also includes an alternative 

approach using a traditional regulatory system requiring all plants to install pollution controls. 

Leavitt portrayed the new period of inquiry as part of the "normal process" of rule-maklng, noting that the ageney had so far filed only a provisional rule. But 

veteran regulators say it is unusual to propose a rule first and do extensive comparative studies later-· unless new information emerges. 

Leavitt said he could not speak to what happened at the agency before he arrived in November, but that he has had "no pressure to do anything other than the 

right thing from the White House." 

Christie Whitman was the EPA administrator when the career employees say they were told not to conduct the analysis. She left the agency in June, six months 

before the proposed rule was announced. 

"I did not know that we were cutting a process short or shortchanging the analysis," Whitman said in an interview Monday. Had she heard such allegations, 

she said, she would have intervened. 

Five current career employees-· all speaking on condition they not be named for fear of job retribution-- and several former officials provided a behind-thescenes account of the EPA's decision-making in the mercury case. 

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Mercury bmssHJns Rule Geared to Benefit lndw;uy, S!affcrs Say" Jat<me5 

A cascade of studies in recent years has cast mercury as an escalating health danger, although its threat to the human nervous system has been known since at 

least the 19th century. That is when hat makers in England literally went mad from exposure to a mercury compound used in processing felt-- hence the 

expression "mad as a hatter." 

Today, the use of mercury in U.S. manufacturing is tightly restricte.d. But there has been no strict limit on mercury released into the atmosphere from the 

nation's 1,100 coal-fired power plants, the largest single source of mercury in the U.S. 

Mercury occurs naturally in the environment, in fossil fuels like coal, and is released into the atmosphere when those fnels are burned. When mercury particles 

and gases drop into water, some tum into a more toxic form known as methyl mercury, which then enters the aquatic food chain. People are exposed to 

mercury chiefly by eating fish. 

In 2000, a National Research Council study commissioned by Congress estimated that each year about 6o,ooo children born in the United States could have 

neurological problems because they were exposed to mercury before birth. Exposure could lead to developmental problems. 

In the past few months, there has been a flurry of other disturbing reports, most focusing on the threat to the fetus from mothers eating fish with elevated 

levels of mercury. In December, the Food and Drug Administration warned all women of child-bearing age to limit their intake of tuna and other fish because 

of concern ahout mercury. 

Coal and utility executives don't dispute the dangers of mercury, but they question how much of the threat comes from power plants. And they warn that 

overly aggressive regulation of the nation's coal-fired plants could damage those industries and the economy and endanger already stretched supplies of 

electricity. 

In its final days, the Clinton administration determined mercury to be a toxic substance and thus subject to strict regulation under the Clean Air Act. The 

administration's decision required that the EPA propose standards for utility plant emissions by the end of 2003. 

As part of this process, the EPA selected a 21-member federal advisory panel in 2001 to make recommendations to the agency. 

Mercury was on the agenda at a staff meeting last spring at EPA headquarters presided over by Jeffrey R. Holmstead, a lawyer who represented industry 

interests on air pollution issues before Bush appointed him to run the EPA's Office of Air and Radiation. Several of the staff members said they had expected to 

discuss plans to cany out comparative studies of proposals to reduce mercury emissions. The studies had been requested by the federal advisory panel. 

The studies were designed to examine the effect~ of mercury regulation on energy markets, electricity prices and public health. This analysis, generated 

through EPA computer models, typically becomes the basis upon which agency officials-- and outsiders-- weigh alternatives. 

But William Wehrum, a senior advisor to Holmstead who also represented industry clients before joining the Bush administration, told the dozen or so staffers 

that comparative studies would be postponed indefinitely. 

~I was floored," said one participant, who has served several administrations. 'We pointed out that the studies were required .. that the data runs were 

promised to a federal advisory committee." 

Holmstead did not respond to expressions of concern, participants said. ''There was an awbvard silence," one recalled. 

After the meeting, two staffers said, Holmstead informed them that the studies would not be conducted partly because of "White House concern.~ 

Holmstead and Wehrum declined repeated requests for comment. On Monday, Leavitt expressed full confidence in them. 

Paul, the co-chairman of the advisory committee, which was made up of regulators, environmentalists and industry representatives, says his panel was 

promised the comparative data last March, but its next meeting was canceled by the EPA and the group uever met again. 

''We were cut off without any warning or explanation," said Paul, director of the Ohio Regional Air Pollution Control Agency in Dayton, who says he voted for 

Bush in 2000. 

Lisa Heinzerling, a professor at Georgetown University Law Center who specializes in regulatory law and has studied the mercury proposal, said the "EPA's 

analytical work on mercury was extraordinarily thin." 

Even as career staffers and some members of the EPA's advisory panel felt that their contributions to the mercury proposal were being restricted, utility 

industry lobbyists were given extraordinarily direct input. 

When the Bush administration took office in 2001, slowing mercury regulation was a priority for the coal and power industries. Documents obtained under the 

Freedom of Information Act show that the coal industry dispatched lobbyists to meet with staff of Vice President Dick Cheney's Energy Task Force on mercury 

and other pollution issues. 

Since 1999, coal and electricity companies and executives have donated $40 million to Republican candidates and committees, including $1.3 million directly 

to Bush campaigns, according to figures compiled by the Center for Responsive Politics. 

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.\i«cmy EmiSSIOns Rule Geared to [lenefit lndusny, Staffers Say -!atlmes 

The administration has responded to key industry priorities: It ended U.S. participation in the Kyoto process to reduce global warming and relaxed regulations 

that required the power industry to install pollution controls when renovating its plants. 

The administration's proposed mercury rule, published in the Federal Register in December, contains numerous paragraphs of verbatim language supplied by 

two separate industry advocates. 

Several complete paragraphs were lifted from three memos provided by Latham & Watkins, a national law firm whose clients include large coal-fired utt1ity 

plants. 

Both Holmstead and Wehrum are former Latham & Watkins attorneys. 

More seriously, according to critics, the proposal also includes exact language provided by West Associates, a research and advocacy group representing 20 

power and transmission companies in California and other Western states. 

The West language suggests a stand~~rd for determining likely mercury emissions at power plants. 

That standard --largely incorporated by the EPA-- is enormously beneftcial to the industry, aC<..'Ording to S. William Becker, executive director of the State and 

Territorial Air Pollution Program Administrators organization, which represents state and local regulators in Washington. 

Leavitt said use oflobbyists' memos in this fashion is not consistent with "normal agency procedure" and that he would prefer that wholesale use of any 

group's language be disclosed. 

Under the proposal, the government would set a national annual cap on emissions but then permit individual companies to choose whether to reduce their 

own emissions or buy "credits" from other companies that do, 

This is designed to provide an incentive to cut emissions nationwide, without limiting them at each individual facility. This approach was widely hailed in the 

1990s for reducing power plant emissions that produced acid rain, but critics say it would be ill advised for a toxin such as mercury. 

Some scientists believe mercury, which is heavier than acid-rain-producing sulfur dioxide and nitrogen oxide, will remain close to the point of emission, 

creating "hot spots" of potentially high levels of mercury contamination near power plants. Power plants in communities with high levels of mercury could opt 

to buy credits rather than spend the money to make reductions. 

The EPA's ov.n Children's Health Protection Advisory Committee, which includes academic, industry and environmental professionals, wrote on Jan. 26 that 

"the cap and trade program, as proposed, may not address existiog hot spots and may create new local hot spots for mereury." 

Overall, the committee said the Bush proposal "does not go as far as is feasible to reduce mercury emissions from power plants, and thereby does not 

sufficiently protect our nation's children." 

Today, coal-fired power plant..:; pump out about 48 tons of mercury annually. The Clinton administration order under tbe Clean Air Act would have mandated 

reducing the amount produced by coal-fired power plants by as much as 90%, to about 5 tons annually by 2008. 

The Bush Clear Skies plan, as modified on Capitol Hi1l, calls for a national cap of 34 tons in 2010, a level that wouldn't require any extra spending by the 

industry because it would be automatically reached if utilities added scrubbers and other equipment to comply with the Clear Skies rules regulating nitrogen 

oxide and sulfur dioxide emissions. 

Opponents of tbe Bush plan contend that setting a lower cap io the near future would encourage innovation by assuring a market for the new equipment. But 

officials of the coal-fired utility industry argue that forcing rapid adoption of that technology would be so expensive that it would lead electric generators to 

shift from coal to natural gas. 

"The result would be increased electricity prices and higher costs for home heating, food and a host of consumer and industrial products," said Scott Segal, 

director of a coal utility trade association. 

Segal and the coal utility companies that make up the Electric Reliability Coordinating Council back the administratiou's market-based approach as the most 

effective way to reduce emissions of mercury and other pollutants without banning the economy. 

Meantime, longtime EPA employees say the administration exaggerated data on the effectiveness of its proposed rule, which would take effect in December. 

In announcing the mercury plan, the EPA said it would reduce mercury emissions from power plants by 70% by 2018. 

However, the EPA's own database shows that emissions would, at best, be reduced by only about half by then, And EPA models suggest that the 70% goal may 

nol be reached unti12025, if ever. 

In recent days, the administration has backed away from those claims. The 70% reduction will be achieved when the rule is "fully implemented," Leavitt said 

Monday, without providing a date. 

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727 

Senator BARRASSO. And I also have a statement for unanimous 

consent. We have multiple State officials who are supporting Mr. 

Wehrum’s nomination. The Association of Air Pollution Control 

Agencies is a consensus driven organization, brings together officials from 20 States, a host of local agencies. 

Clint Woods, who is the Executive Director of the organization, 

stated that ‘‘Through his comprehensive knowledge of the law and 

experience in the Federal Government, Bill possesses the background to manage challenging Clean Air Act issues at U.S. EPA 

and to help continue the tremendous air quality progress that has 

been achieved in our country over the last several decades.’’ 

Without objection, that will be submitted as well. 

[The referenced information follows:] 

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27172.664

1011712017 ~!.e--BII-..mEPA-IU.S.I!PA--IUSEPA 

We've made some c:ban8esto EPA.gov. Ifthe infonnQtion you an: lookillg 

fur Is not here, you may be ablo to find it on lbe EPA Web Arl:bive or the 

January 19,2017 Web Snapshot. 

News Releases from Headquarters > Office of the 

Administrator (AO) 

Environmental Leaden Praise Bill Wehrum EPA 

Nomination 

Wehrum Nominated to Head Air and Radiation 

Office 

CONTAcr:~sov 

WASHINGTON (September 7, 2017): Today, President Donald J. Trump 

lllltlOUttced his intmticm to nolllinatl! BiU Willlnlm to SetVe sa EPA As&isllmt 

Adminisfnltor fur the Office of Alr and Radiation (OAR). Ml:. Wllbrum has a long 

history of public service, and previously served as EPA's acting assistant 

administrator fur Ait and Radiation from :1005 to 200? and as EPA's principal 

deputy &llllstant administmtor and coUDBd to the assistant admini.mator fur Ait 

and Radiation. He is cnrrently p&l1ncr 8Jld head of the Admini•trative Law Group 

at Hunton & Williams LLP where hi• pJ'aj)tice focwes oo air quality iosues. Mr. 

Webnlm's CORer includes over 31 yc:art1 working in the cnvirolimental field 

through engineering. legal practice. and administrative duties. 

His nollllnlltlon ill receiviDa high aetOhtdl!ll from envfmomeatalleaders 

across the tOtmtry: 

Sean Aller!, director, Kelltucky DMsloa for AU- Quality and 2817 president 

oftbe AnodaUoll of Air Pollutioa Control Agendet: uConsideriog bis 

educatiot1 and experience as a cbcmical engineer and an eovironmentalllttomey, 

Mr. Webrum will be well-positioned Ill provide clear, concise dinlc1ion to address 

the many diverse, complex air quality issues. As a studem of die Clean Air Act. 

Mr. Wcbrum'slcDowlcdge and experiencewm greatly benefit EPA, state, and loce.l 

air pollution contrnlagenti£8. We look forward to working with Mr. Wehrum and 

EPA's senior leade.nhlp to improve air quality in Kentucky and throughout uur 

nation. The Kentooky DivWon fur Air Quall!;y supports Mr. Wcbnun's 

nrunination to serve as the a&Biilantadminietrator of EPA's Office of Air and 

Radiation." 

112 
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27172.665

101'\712017 Er>-III~PralleSil- EPA-JU.S.EPA--IUSI!PA 

Johli Crudea, prafdent-eleet o{lfle AmerieaD College of ED9irollllleltal 

Lawyen 1111d assist1mt aHorney ~:eaenl. ED'IIiro1unent and Natural Resoan:e~ DlvlatGn. U.S. Department of Jultk.e (Uiltl14-l/1017): "I haw worked with 

Bill Webrum while he was a senior official at EPA diJl'ins the Bush 

Adminiatration, rmd have full owed his impresllive career in private practice. I 

believe he is cOlllmitted to achieving clean air for all citizens and c:are!Wiy 

following sound and C1liTent science. • 

JeffHolnutead, -lltant adm!DL'ltmo&; Ot11ce of' Air 11114 Radlatioa, EPA 

(2001 -ZOOS): "Bill is eommined to the goals of the Cleln Air .Act and to the rule 

of law. He is also a person Qftbehighest integrity. I am coofidenttbat. within the 

frlllncwork established by Congt'e(s, he wiU work ID protect public health and the 

mvirorunent while at the same time purauing recuJfltocy reforms tbat will reduce 

unoecessaty regulatory bunlens. Truly, there is no better person to seMI aa the 

wistant adminiBttator of EPA's Office of Air and Radiatian." 

Mllmls P-k, EPA deputy admbiistrator (11811005- OlllOO!I): "Bill 

Wehrum'sUildentandiDg of lhe Clean Air Act may be second to none. His desire 

to )ll.lll up bis aleeves and actually make the Clean Air Act wort as a pmctical matter is seoond to none." 

Cllat Woods, lliiiCildve direebtr, Auudatfon of Air Polln1ioa Control 

Agmdes> "Through bis ~ve knowledge of the law lind experiena: in 

the federal govemmcut, Bill pOS8CSBCS the backgrouml fn 11181lagtl challenging 

Clt:an Air Act issaes at U.S. EPA and help continue the lremendous air quality 

progress that has been achieved in oar country over die last several decades. 

Under his leadership, !Jle Office of .Air rmd Radiation will be well-situated to 

pursue a bs<:k-to-bulcs agenda grounded in coopen~tiw fedefalism." 
730 

Senator BARRASSO. Senator Inhofe. 

Senator INHOFE. Thank you, Mr. Chairman. 

During the first round of questions I was critical of the previous 

administration, Mr. Wehrum, for not following the law. It was 

ruled that they were not accurately following the law in terms of 

coming out with the costs and evaluations of various emissions 

standards, and you said that you would comply with the law if that 

happens. 

But there is another condition that they have where they had not 

been complying with the law, and that is the Clean Air Act also 

calls for the Clean Air Scientific Advisory Committee to evaluate 

implementation issues related to air quality standards. Yet, that 

wasn’t done. 

Should it have been done, and will it be done, if you are confirmed? 

Mr. WEHRUM. Senator, CASAC has a role specified by statute 

and advising the Administrator on setting national ambient air 

quality standards, and there has been a suggestion that CASAC 

has not been implementing its complete, full set of obligations, focusing only on certain aspects of the job and not others, so I believe 

it is important for CASAC to fulfill its complete role, sir. 

Senator INHOFE. OK. 

Mr. Dourson, I have 20 kids and grandkids, and you have a 

bunch out there, too, and despite what the critics think, we want 

them to grow up in a healthy environment. I care about the world 

we are going to leave behind for them, and you, too, are a father 

and grandfather, and I imagine that your family is a big driver for 

you in your work over the last 38 years. What led you to pursue 

this field, and why do you want this job? 

Mr. DOURSON. Thank you very much for the question. No, what 

led me to this field was some time in West Africa with a medical 

doctor, and I got enamored with the idea of preventive medicine. 

So after school, graduate school, I went into toxicology. It was funded by the U.S. Government on a stipend. I learned that this particular area was preventive medicine, and so I became enamored 

with that. 

To fulfill my duties of the stipend, I started working with U.S. 

EPA immediately thereafter, and I have grown to admire the people of the U.S. EPA, and of course, I have had the good time to 

work with a non-profit organization since then. So, in each of these 

cases it is the lifelong career objective of protecting the American 

people and their sensitive individuals and the environment from 

chemical pollution. 

Senator INHOFE. Out of curiosity, where in West Africa was it? 

Mr. DOURSON. Liberia, West Africa, before the wars. It was a 

very peaceful country. 

Senator INHOFE. Yes, I know that. When we met in the office last 

month, you said of your non-profit that only a third of the research 

was at the request of industry. What was the majority of the organization’s work focused on? 

Mr. DOURSON. Two-thirds of our work is government organizations, over 70 different government organizations. And also a big 

part of the work is collaborative opportunities. So we worked with 

government and industry often in collaborative modes. Many of the 

731 

chemicals that came up before where all these numbers were up or 

down, or something like that, were collaborative ventures, including government and other groups. 

Senator INHOFE. Were you involved in pro bono type work? It is 

my understanding that some 10 percent to 20 percent of TERA’s 

work was also pro bono. Can you provide us with an example of 

pro bono work? 

Mr. DOURSON. Yes. Thank you, Senator. So, when we started 

TERA, we did this free State help, what we call it SHELP, State 

Hazard Evaluation Lending Program, and we gave free assistance 

to any State. We have worked with many States in that capacity. 

Another example of scientific societies, the one that is most fulfilling to me is we are a public organization; we have members of 

the public come in. We had a young mother come in to my office 

1 day. She was distraught. No one had been listening to her; she 

had nowhere to turn. She went to the Web, found our site. As she 

relayed her story, her family had been poisoned, and it became obvious to me that the poisoning was likely to be hydrogen sulfite, 

which is a very serious poison. Her four children were affected; her 

horses were affected; the dogs were dead. I mean, it was a really 

pretty severe case. 

So, after a little bit additional study, we were able to get her the 

medical attention and then the legal support that she needed to 

carry on, and that made the local news several times. That was 

very gratifying, although, honestly, dealing with the public one on 

one like that is not always the most direct part of our pro bono. 

Senator INHOFE. Well, good for you. 

Mr. Leopold, you have worked on several large scale environmental issues in your time in private practice and on behalf of the 

State of Florida. Could you give us a quick overview of these and 

your work on these issues? 

Mr. LEOPOLD. Thank you, Senator. Yes, I have been fortunate to 

work on some of the biggest environmental cases going. I am very 

proud that I worked on the BP oil spill enforcement case, spent a 

couple years helping the Justice Department hold BP accountable 

for that spill and resulted in the biggest Clean Water Act penalty 

in U.S. history. 

Also, the Everglades litigation. I helped support the State of 

Florida in advancing restoration on the Everglades. 

So those are two of the big ones. 

Senator INHOFE. Good. 

Thank you, Mr. Chairman. 

Senator BARRASSO. Senator Merkley. 

Senator MERKLEY. Thank you, Mr. Chairman. 

Mr. Wehrum, do you believe with high confidence that human activity is a major driver of climate change? 

Mr. WEHRUM. Senator, I am sorry, your question, I didn’t 

hear—— 

Senator MERKLEY. Do you believe with high confidence that 

human activity is a major driver of climate change? 

Mr. WEHRUM. I think human activity contributes to climate 

change, Senator, yes. 

Senator MERKLEY. When you say yes, do you believe it the major 

driver of climate change? 

732 

Mr. WEHRUM. I believe that is an open question, Senator. 

Senator MERKLEY. That is certainly the type of answer that we 

hear continuously. That is the coached answer that the Koch brothers are asking people to sew this uncertainty, so we have seen that 

in answer after answer that comes before this Committee, such as 

statements from Mr. Pruitt, statements from Mr. Tillerson, statements from Mr. Perry, all citing this, oh, we are just not sure if 

it is significant or not. Maybe it is contributing, but we are just not 

sure if it is significant. 

So let’s take a look at the NASA charts. I am going to put up 

a chart that shows NASA’s evaluation of the contribution of solar 

energy. We see the yellow line on this chart, the flat line that goes 

across. Virtually no variation over the course of 125 years. And we 

see the enormous variation in the climate. Do you see any correlation, significant correlation between the yellow line and the black 

line? 

Mr. WEHRUM. Senator, I have no idea what that depicts. 

Senator MERKLEY. Well, I just explained it to you, so let’s try it 

again. I think you are supposed to have a background capable of 

understanding this sort of thing. Solar energy, temperature of the 

planet. NASA statistics. Does there appear to be any correlation 

between those two lines? 

Mr. WEHRUM. Senator, I will respond to you as I did to questions 

on the renewable fuel standard. These are very complex issues, and 

they are very important issues, and I understand that they are important to you, so—— 

Senator MERKLEY. OK, thank you. We will go on to the next 

question, because anyone slightly familiar with statistics would say 

a flat line and a rising line do not show correlation. 

Another argument is that volcanic activity, the Earth’s orbit, as 

well as solar activity contribute. That is what NASA has compiled 

collectively under the bottom chart. We have the natural factors, 

those three that I just summarized, and then we have the rising 

temperature in the black line. Does there appear to be any correlation in this case? 

Mr. WEHRUM. Again, Senator, I will say I am not familiar with 

those data; I have no idea what it shows. 

Senator MERKLEY. OK. Well, if you can’t read a chart, are you 

qualified to have this role? 

Mr. WEHRUM. Senator, what is important is to understand the 

data underlying the depiction, and I have had no opportunity to see 

those data or understand how they have been depicted. 

Senator MERKLEY. You have been working in air pollution for 

these decades, and you have no acquaintance with data related to 

the warming of the planet or the factors that contribute to that? 

Mr. WEHRUM. Senator, all I said is I have no idea what data contributed—— 

Senator MERKLEY. OK. Well, let’s turn to the third chart, then. 

NASA has compiled a third chart. This one, again, shows the rising 

temperature in the same color, in black, and it shows the rising 

greenhouse gas emissions. Can you, without great familiarity, acknowledge that these lines generally track each other? 

Mr. WEHRUM. Once again, Senator, I am not familiar with those 

data; I have no idea what it depicts. 

733 

Senator MERKLEY. You can see the lines. Do the lines track each 

other? 

Mr. WEHRUM. What is important, Senator, is to know how the 

data are depicted. Understanding the underlying data and understanding the—— 

Senator MERKLEY. Yes, it is, but I am just asking you a question. 

Can you see those two lines and do they generally track each 

other? 

Mr. WEHRUM. Well, again—— 

Senator MERKLEY. OK, thank you. 

What we have seen is this Koch Brother inspired determination 

not to acknowledge even the most fundamental facts, and continuous excuses that perhaps the temperature of the climate is going 

up because of solar activity. Oh, no. No, wait, maybe it is volcanic 

activity. But when NASA presents the information that shows 

there is no correlation from those factors, and extensive correlation 

from carbon dioxide and other global warming gases, individuals 

like you simply refuse to acknowledge it. 

Why should the American people put into an office of significant 

influence someone who refuses to look at the facts directly that are 

so important to the health of this planet? 

Mr. WEHRUM. Senator, as I said a second ago, these are complex 

issues and very important issues, and I commit myself, if confirmed, to speak—— 

Senator MERKLEY. Do you think on such a serious—so, in Oregon 

we have lost a billion oysters due to the increasing acidity of the 

ocean that is caused by carbon dioxide becoming carbonic acid. Are 

you familiar with this problem? Yes or no, are you familiar with 

the increased acidity? 

Mr. WEHRUM. I am not familiar with the oyster industry in Oregon, no, sir. 

Senator MERKLEY. Are you familiar with the increasing acidity 

of the ocean? 

Mr. WEHRUM. I understand there is an allegation that—— 

Senator MERKLEY. Oh, my goodness. You have to be kidding me. 

Really? 

Mr. WEHRUM. I understand—— 

Senator MERKLEY. You are in this field and you have never read 

anything about the increasing acidity of the ocean? Well, how about 

the fact that we have a fire season that is 2 months longer than 

it was 4 years ago? Are you familiar with the growing length of the 

fire season? 

Mr. WEHRUM. I have not—— 

Senator MERKLEY. Are you familiar with the extending range of 

pine beetles that are having a devastating impact on our forests 

and creating an area that you can fly over called the red zone? 

Mr. WEHRUM. As I said, Senator—— 

Senator MERKLEY. Are you familiar with the snow pack in the 

Cascades? All of these things, no one can look at what is happening 

on the planet and see that there is nothing happening unless you 

are deliberately determined to ignore that information, and that 

makes you really, quite frankly, unacceptable to serve in this capacity. 

Thank you, Mr. Chairman. 

734 

Senator BARRASSO. Senator Carper. 

Senator CARPER. Mr. Chairman, I have a unanimous consent request to enter an op-ed written by Senator Whitehouse that is in 

my hands, and I would like to ask unanimous consent to be inserted into the record. 

Senator BARRASSO. Without objection. 

Senator CARPER. Thank you. 

[The referenced information follows:] 

735 


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The Corporate Capture of EPA-" Sheldon Whitehouse~ Medium 

About membership 

Sheldon Whitehouse 

the Ocean State. 

Oct 4 · 4 min read 

The Corporate Capture of EPA 

Anyone who thinks the Environmental Protection Agency should care about public 

health more than corporate wealth should tune in to today's Senate Environment and 

Public Works Committee nominations hearing. You'll get to watch the capture of EPA 

by regulated industries in real time. This ever-deepening reach of corporate interests 

into our environmental regulator will have consequences for this generation and those 

to come. 

The tone at EPA is set from the top. Administrator Scott Pruitt has a long record of dark 

money fundraising and cozy relationships with big fossil fuel political donors. Oil and 

gas giant Devon Energy, for example, has been a generous supporter of Pruitt's 

campaigns. While Pruitt was in leadership positions with the Republican Attorneys 

General Association and its predecessor, the Republican State Leadership Committee, 

Devon give these entities almost one million dollars. 

Thanks to Pulitzer Prize-winning reporting by the New York Times, we know that 

backing Pruitt was a good investment. In 2011, then-Attorney General Scott Pruitt took 

a letter written by Devon Enercy, put it onto his Oklahoma Attorney General letterhead, 

-

Never miss a story from Sheldon Whitehouse, when you sign up for Medium. 

https://metlium.com/:0'-senwhitchousc!thc"corporate~capturc·of~pa· 7c2652624c84ll 0/12/2017 12:42: 16 PMl 
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The Corporate Capture of EPA -Sheldon Whitehouse- Medium 

specifically benefit long-time Pruitt benefactor Devon Energy. 

We still don't know the full depths of Pruitt's ties to industry. Senate Republicans 

jammed his nomination through without demanding answers to questions raised by me 

and my Democratic colleagues on the Environment and Public Works Committee. And 

now, 229 days after he was sworn in Administrator, we still wait for Chairman John 

Barrasso to bring Pruitt before the Committee for an oversight hearing. 

After Pruitt's sham of a confirmation, it's no surprise that industry feels free to jam 

through a slew of industry cronies. Michael Dourson is a prolific industry-funded 

"scientist" and a key architect of the industrial climate change denial apparatus. In 

2012, the Center for Progressive Reform released "Cozying Up: How the Manufacturers 

of Toxic Chemicals Seek to Co-opt their Regulators." The report detailed the work 

Toxicology Excellence for Risk Assessment, the "non-profit organization Dourson 

founded, has done to undermine public health protections." It also found a third of the 

group's revenue carne directly from industry, with another 30 percent corning from 

"non-profit sources often dependent upon chemical manufacturer support." 

If confirmed, Dourson will be in charge of implementing the Frank R. Lauten berg 

Chemical Safety for the 21st Century Act. He will have the final say over which and how 

many chemicals are deemed high priority, which uses are considered in risk evaluations, 

and the stringency of the safety requirements EPA sets for chemicals found to be unsafe. 

Consumers deserve to be confident that the chemicals in everyday products are safe; 

they won't have that confidence with Dourson at the helm. 

Bill Wehrurn has been nominated to serve as EPA's top air official. Wehrurn's clients are 

a who's-who of polluting industry, including the American Petroleum Institute, Koch 

Industries, American Fuel & Petrochemical Manufacturers, and the Utility Air 

Regulatory Group. Wehrurn's firm, Hunton and Williams, directly contributed to Scott 

Pruitt's attorney general campaign and gave over $zoo,ooo to RAGA and the 

https://medium.c-om/@senwhitehouse/the~corporate~capture~of-epa-7e2652624e84j t 0/12/2017 12:42:16 PM] 
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'lbc Corporate Capture of EPA- Sheldon Whitehouse- Medium 

Republican State Leadership Committee. 

Through documents produced from Oklahoma Open Records Act requests, we know 

that Hunton and Williams staff worked with Attorney General Pruitt and industry to get 

other state attorneys general to oppose EPA's carbon pollution standards for new power 

plants. Hunton and Williams attorneys also counseled Pruitt's staff on who to approach 

about signing on, and coached them on how and when to submit the comments. 

Wehrum fought EPA's Mercury and Air Taxies Standard, Clean Power Plan, Cross-State 

Air Pollution Rule, methane standard for new oil and gas development, greenhouse gas 

reporting rule, and many other environmental protections. If confirmed he'll be in 

charge of them. 

Americans trust the EPA to protect the water we drink and the air we breathe, and to 

police the chemicals and pesticides to which we're exposed. They should also trust 

Congress with protecting EPA from being captured by the industries that it regulates. 

We've seen too often what happens when wealthy and powerful industries gain 

excessive influence over the agencies that regulate them. The capture of the Minerals 

Management Service at the Department of Interior contributed to the oil spill in the 

Gulf of Mexico in 2010. The Securities and Exchange Commission and other bank 

regulators looked away as financial services companies created exotic and irresponsible 

financial products that took our economy to the brink of collapse in 2008. 

Regulators who are in the tank won't do their jobs. If we continue to look the other way 

when nominees like this come before the Senate, we can expect scandals and recurring 

disasters in the future. That's no way to govern. Regulators owned and controlled by 

industry are not the American way. 

https://medium.com/@senwhitchouse/thc-corporate~capture~of~epa~ 

-- 7e2652624c84fl 0/12/2017 

-

12:42:16 PM) 
738 

Senator CARPER. I would also like to ask unanimous consent to 

insert a number of other letters and articles about today’s nominees into the record, please. 

Senator BARRASSO. Without objection. 

Senator CARPER. Thank you. 

[The referenced information follows:] 

739 


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10/312017 Hunton & Wil6ams Scores EPA Bigwig ~ Law360 

LAw~ Portfolio MMi•.lnc. jlll West 19th Street, 5th floor 1 New York, NY 10011 I www.law360.com 

Phone; +1 646 783 7100 1 Fax: +1 646 783 7161 1 cuitomerserYice@lawJ60.com 

Hunton & Williams Scores EPA Bigwig 

By Anne Urd• 

Law360, New York (September 19, 2007, 12:00 AM EDT)-- Continuing to bulk up its environmental 

law department, Hunton &. Williams LLP has snagged a former bigwig at the U.S. Environmental 

Protection Agency to help further the group's ongoing expansion. 

On Wednesday, Hunton &. Williams revealed that Bill Wehrum had joined the firm's Washington, D.C. 

office, where he will serve as a partner in the resources, regulatory and environmental law practice. 

"With Bill's experience at EPA, he brings a unique perspective to the problems companies face; said 

Hunton & Williams partner F. William Brownell, co-head of the firm's resources, regulatory, and 

environmental law practice. 'He will be an Invaluable resource for our clients seeking to navigate an 

increasingly complex regulatory process." 

The new hire gives even more heft to an administrative/regulatory practice area that already stands 

at 115 strong, with half of those devoted exclusively to environmental issues, accondlng to the firm. 

Though Wehrum began his career as an environmental engineer for a major U.S. chemical 

manufacturer and then headed into private practice, the latest Hunton & Williams addition hails most 

recently from the EPA. 

Wehrum started his six-year gig there by serving as chief counsel for the Acting Assistant 

Administrator for Air and Radiation before assuming the role himself for the past two years. 

During his tenure, Wehrum helped to draft and implement the Clean Air Interstate Rule and the 

Clean Air Mercury Rule, helped revise the EPA's New Source Review permitting program, review and 

revision of the National Ambient Air Quality Standand for particulate matter, helped put into place 

federal fuel and emissions standards for heavy duty highway vehicles, and proposed emissions 

standards for locomotives and marine engines, according to the firm. 

Though he views his stint at the EPA as priceless, Wehrum is looking forwand to retumlng to the 

private sector and tackling the new set of challenges that will accompany this shift. 

"I had been at the EPA for six years when I left the agency in June," he said. "I felt like that was a 

good long run. I had a great experience at the agency but I knew I always wanted to return to the 

practice of law and this was the right time." 

In his new legal home, Wehrum will focus his attention once again on air quality issues, with a 

particular emphasis on compliance counseling, permit negotiations and regulatory and legislative 

advice. 

Wehrum believes that Hunton & Williams will be the right fit on both a professional and personal 

level. 

"Hunton &. Williams has always been a great law firm, and they have a very large and successful 

environmental practice so from a substance standpoint, it was a really nice match," he said. 

In addition to the firm's well-respected reputation in the field, part of Hunton &. Williams' appeal for 

Wehrum arose out of past dealings with his future colleagues. 

httpsilwww.law360.com/articles/35404/print?seetlon=energy 112 
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101312017 Hunton & Williams Scores EPA Bigwig ~ Law360 

"~They are great lawyers and great peoplet he said. "That was a big attraction." 

With the U.S. Supreme Court's recent ruling in the Massachusetts v. EPA case and other important 

regulatory cases pending, Wehrum and the other members of the environmental g<9up will likely 

have their hands full in the coming years. 

"The Clean Air Act is the statute that just keeps on giving," he said. "It's been almost 20 years since 

the Clear Air Act was last amended but there continue to be a series of issues that spin off the Act. I 

think It's going to be a source of work for a lot of people for a long time to come.• 

To that end, Wehrum believes that his tenure at the EPA will prove to be Important as he settles into 

his new role at Hunton & Williams. 

"I'm a much better lawyer now than when I first joined the agency," he said. "To really get to know 

how the agency works and how it ticks, I think that is very valuable. I have expanded my capabilities 

which will hopefully allow me to be effective in generating business and clients." 

All Content Cl 2003~2017, Portfolio Mediat Inc. 

htlps:llwww.laW300.com/artldes/35404/prfnt'1section=ena'l!Y 
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10!3/2017 REGULATIONS: 'People are designed to deal with dust' - EPA air nominee -Tuesday, Septemb$r 26, 2017- www.eenews.net 

THE LEADER IN ENERGY AND ENVIRONMENT NEWS 

'People are designed to deal with dusl'- EPA air nominee 

Ama1lda Reilly, EU ftkws ruportor 

Published: Tu~y, Septemi)er 26. 2017 

Pt'li:lsldent Trump's pick to head U.S. EPA's air office o~~ttemprod today to poke holes in the sci.entific justification for 

Obama adminislrath:m standards meant to prOO.tct workers from inhaling llny and somcttme.s deadly sKica 

partlckls. 

Representing industry ehai!engers, attorney William Wehrum In part argued that people had nphyslofogical 

mechanisms'" tQ deal with dust at the levels that the Occupational Safety and Health Administration says are 

harmful and causa respiratOl)l d!.soases. 

~People are designed to deal with dust,~ Wehrum said. "People ars in dusty ap.a~ts .all the lima ar'td it <J::resn't 

kl!l tham.~ 

\Nl!fiam Wrmrum. Hunton llf1(l Woli4lm!l 

LLP. 

Wehrum was one of .eight attomeys to argue tOday over the future of the 

Obama admlnlstratloo's sM!ca sto~~ndards. A throo-<judge panel of the U.S. 

Court of Appeals for the Ois.trict or Columbia Circuit heard more than two 

hours of arguments ln a packed courtroom. 

Earlier th1s month, Trump nominated Wehrum, who leads the admtnlatratlve 

law group at Hunton & Wihiams LLP, to sai'Vt:l as assistant administll.'ltor for 

EPA's OffiCe of Air end Radiatlon. 

Wahrum ls a former EPA official in the George W. Bush administration, 

joining EPA as counsel in 2001 end b&c;O(ning acting air chief in 2005. Bw~h 

nDI111tmted Wchrum to servo pennanently, but hls record came under bltlng 

attack by Democrats and he Wa:j never eonfirmGd. 

Envlronm&ntallsts have opposed Wehrum's nomination to the top air of'licepos.ii!on, where he would be in charge of unr;;~veting some of the Obama 

administration's signature alr rules. Ha has y~t to go through h!s Senate 

confirmaUon hearing {/I.i~. Sept 20). 

The focus of today'$ arguments was not an EPA regutation but rathnr a rule tss~ by tho Department of Labor's 

OSHA in 2016. 

In its Nle, OSHA decreased the 1971 expoSlffa fitnit to sll!ca partie:!$ from 100 micrograms of respirable 

crystalline silica per cubic: me:ter of air for genera! indll&try to 50 micrograms. which !t said would ~'tantfolly 

reduce the rtsk of PUblic health impacts. The- Obama adminisrration a!so increased protections 1t1 an affe.ctM 

industries, with exceptions for some aQ'fiwlture prn:ctioos ~. March 24, 2016). 

Crystamne silica Is ubiQuitow m eonstnu;tiQn and manufacturing !ndust:ries around the wortd. It's a major 

component of most buitdlng products, InclUding brick, concrete, shinghts and <:emmic tile, and Js present ln 

erushed stone and gravel used to construct roods. 

But inhaling tiny silica partidas can .cauSQ health probli.>'ms, including silicosis, respiratory diseases such as 

COPD, l1,.1ng .cancer and kidney disease, 

According to OSHA, the new standard would prevent 64.2 deaths and 918 si!lca..fela!ad mnesses a year, With a 

tnorn.')tizadannual benefit of $8.6 billion, Jn au, the rule was expected to affect neerty 700,000 facilities in !he 

United Slates and more than 2.3 mflHon workers, 

Dozons of industry entities and trade- unions sued over the 1'\j}e, wtlk;h became effm.:tive in J1,.1ne 2016 with 

phased-in compliance deadlines. A special jtJdlclal panel on multidtstrict litigation sent the consolidated chaHenges 

to the O.C. Circuit. 

'Signfficant risk' 

Industry cal!i!i the rule ~one of the most far-reaching heaJ:!h s.tandartls: promulgated by OSHA in the last two decades.» 

httJJs:/fwww.eenews.net/greenwire/stoMs/10600$1731! 1/3 
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10/3/2017 REGULATIONS: 'People 1118 designed to deal with dust' - EPA air nominee - Tuesday, September 26, 2017 - www.eenews,net 

One of industry's main arguments is lhat OSHA failed to :sf'low that thMe's a significant risk at expo:s~.~re levels of 

100 m1crograms and that lowering the limit to 50 micrograms fQr general industry will sub&tanltaHy reduce healh 

..... 

'We believe that when you take a hard took. in fact, their level of ~roof doesn1 rise to the level of substantial 

evidence," said Wehrum, who's ~ting the Brick lfldustly Aasociation and National Stone, Sand & Gravel 

Assodatlon in the Htlgatlon. 

The groups have accused OSHA of c:herry-picklng data tmm studies to support a poticy cholce to tower the 

standard. 

'We assert that OSHA had a thumb on Ute scale.~ Wehrum said, 

They also say OSHA's aoalysls was flawed because it made the '\Insupportable II:S8umptlort" that there's no 

threshold exposure lew! of sltlc:a-f81ated respiratory dtsease. In other words, OSHAauumed therv.'s no exposure 

level at which a pemon will not become ilf and that people will become itt and die at levels below 50 micrograms. 

OSHA ~predicts bodies in tt'te streets," Wehrum said, adding that "objedlve evidence" doesn't support the 

conclusion. 

He also pointed to trend Hnes showing that deaths related to silicosis have faHen more then 90 percent between 

the earfy 1970s, when the country's first silica standard was put In pblce, and 2010. 

"Common sense" says that the CUITent standafd "seems tQ be wtnlng," he argued. 

But D.C. Circuit Chief Judge Merrick Garland appeaAid skeptical. "Ttlerv. are scl&ntlsts that believe the opposite 

of you," he said. 

Gartand, who presided over lOday's arguments, noted that on issues where there's a leglUrnate SCientific dispute, 

it's "perfectly approprlale• for OSHA to weigh Jn fBYor of more protections for workers. 

Judge Oavki Tate!, a Clnlon appolntea, also lOok issue with 8fQUments presented by the U.S. Chamber of 

Commerce on death certificate data kept by the Center.l for Olseeae Control and Prevanlion. Michael Connolly, an 

attomey representing the U.S. Chamber, argued that the data "fundamentally underrnitles'" tha new standard 

because it 'Shows en "enormous decline" In ailieosls dealtls. 

But Tatel called OSHA's argument~~· that the data represent a dedine In workforce participation during thai 

Ome. 

Krtsten Uncrberg, a senior attorney at OSHA. urged the court to uphOld the standarda. 

"lnduslry pelltionefs want you to rejecl conctusions lhat have overwhelming support among scientists," she said. 

Feasibility 

lndustty's OCher key argument is lhat the rule ts neither tachnologicafly nor eoonomicalfy feasible for the foundry, 

hydnti.JIK: fracturing and construction industries. OSHA says conlrol technologies 9nl wldety available, but ind~rry 

says the agency never Identified how the lower standard could be met and whether employers can even achieve lt 

at all. 

The new standard "wit! serve only tQ impose enormous new costs on Industry with no cognizable health benefits 

for worker$ at afl," the groups said In a coun brier. 

In the construction induslry, the standard cannot be met most of the time by engineering controls, meaning 

warken;; wHI fraquentJy have to wear resplmton, said Bractford Hammock. an attorney at Jackson Lewf&. arguing 

on behalf of induslry trade groups. 

HydrauiJcfracturing Is another lndustrythars significantly affected by the rule, Driflens ii'IJecisilica sand to drive out 

oil. 

OSHA estimated that it wcuid cost hydraulic fractur1ng operatlons 0.56 percent of ltleir annual rv.venues, or 7.94 

pen::ent of annual profits, to mEtet IN new standards. The agency identified certair1 controls, including exhaust 

ventHation end passive dust collection systems, to lower allk:a dusl 

Other technologlea are under development and can be widely implemenled within the five-year compliance 

deadHn& for lha sector, OSHA SB)'$.. But industry contends that OSHA underestimated compliance c:ostiJ and that 

control technologies are not on lha "horizon.~ 

AJ. IN SJguments today, judges dug into the competi119 studfes, models aod mathematic calculations presented by 

induBtry and OSHA on the rule's costs, lechnologtes and varlabilily among operations. 

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101312017 REGULATIONS: 'People are designed to deal with duc;t'- EPA air nominee - Tuesday, September 26, 2017 - www.eenewa.net 

Judge Karen LeCraft Henderson, a George H.W. Bush appointee whO was otherwise relatively quiet during the 

arguments, saved one of hertew questions !Or the rule's impa~ on hydraulic trac:turing. At the time of the rule, 

OSHA found !hat many operetlons hacln, yet met the previous standan:l of 100 micrograms. 

"How are they doing so l'ar?" Hendemon asked. 

Lauren Goodman, an OSHA attorney, saki control technologies were being rolled out but eonc:eded that there was 

limited data. She said standards can be ,echnology fotcing." 

Laler, she pushed bcwk on industry's arguments over the economic feasibtlfty of the rule. 

"An OSHA rule Is not !nfeaalble just because it is costty pr even very co$tly," Goodman said. Judges could only 

find an OSHA rule ls economically infeasl:l&e "tf It threatens the do\wtfall of an entire industry, • she said. 

Union chaUenges 

Labor unions intervened in the litigation on behalf of OSHA but also filed their own d'latlenges to the rule. Unlike 

industry, they argue that the rule is too weak. 

N. lsaue: OSHA's d&cision not to protect 'lo'Ofkenl from losfng pay If a doctor recommends they be removed from a 

job due to silica exposure. Unions are also protesting the rule's medical surveillance rvquirements for CDflstrudion 

-

"OSHA was requintd to do more to protect the hundreds of thousand& ofwotlteni who continue to face signlftcant 

health risks from exposure to silica under the new standard.," the unions aaid in a eourt brief. 

TvAtter. @apeterka I Email: a~llly@M-newa.net 

The essential news for energy & environment professionals 

~199fi..2017Environfrlllnt&EIIergyPublll:t\blg,LI..C ~~ 

hHps:/1www.aenewa.!1&tlgreenwire/storiesl1060061731/ 
744 


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Dubious Choices · The New York Times 

D 

Opinion EDITORIAL 

Dubious Choices 

APRIL 24, 2006 

President Bush has asked the Senate to approve nominees for two important 

federal posts with great influence over environmental policy. Neither 

candidate is particularly good news. One should certainly be rejected. 

Mr. Bush has nominated William Wehrum to succeed Jeffrey Holmstead to 

head air pollution programs at the Environmental Protection Agency. The 

Holmstead era produced several positive initiatives. But it will be 

remembered chiefly for its efforts to weaken the Clean Air Act (particularly 

with respect to rules governing mercury emissions and older power plants), 

to manipulate science and to elevate corporate interests above those of the 

public. 

Mr. Wehrum, who served as Mr. Holmstead's deputy and doctrinal hit man, 

could make things worse. Opposition to his nomination has been building 

rapidly in the Senate Environment and Public Works Committee, where the 

vote could break largely along party lines. If it does, the nomination may 

hinge on two senators whose views on Mr. Wehrum are not known: James 

Jeffords, an independent from Vermont and a consistent critic of the 

administration's clean air policies, and Lincoln Chafee, an environmentally 

inclined Republican moderate from Rhode Island. 

The second controversial nominee is Dirk Kempthome, the Idaho governor 

who is Mr. Bush's choice to succeed Gale Norton as secretary of the interior. 

Mr. Kempthorne, a former senator, is sure to be approved despite a poor 

environmental record. 

Perhaps his experience in the Senate, with its tradition of give-and-take, will 

make him more amenable to compromise than the ideologically driven Ms. 

Norton, who tended to favor commercial interests at the expense of publicly 

http://\V\\'-w.nytimes.com/2006/04/24/opinion/dubious·choices.html[9/l9/20l7 11:23:02 AM] 

D 
745 


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Dubious Cboioes ·The New Yoric; Times 

owned resources and who acquiesced in a series of disastrous cuts in 

conservation programs. 
746 


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OH i( • < l:\SPl TOR GENER:\L 

Evaluation Report 

Additional Analyses of Mercury Emissions 

Needed Before EPA Finalizes Rules for 

Coal-Fired Electric Utilities 

Report No. 2005-P-00003 

February 3, 2005 
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27172.677

Report Contributors: 

Abbreviations 

CAA Clean Air Act 

CAIR Clean Air Interstate Rule 

Rick Beusse 

Carolyn Blair 

Hilda Canes 

Sarah Fabirkiewicz 

James Hatfield 

Erica Hauck 

James Huber 

CHPAC Children's Health Protection Advisory Committee 

EPA Environmental Protection Agency 

FACA Federal Advisory Committee Act 

OIG Office oflnspector General 

ICR Information Collection Request 

IGCC Integrated Gasification Combined Cycle 

IPM Integrated Planning Model 

OMB Office of Management and Budget 

MACT Maximum Achievable Control Technology 

NTEC National Tribal Environmental Council 

NOx Nitrogen Oxide 

OCHP Office of Children's Health Protection 

S02 Sulfur Dioxide 

Cover photo: Virginia Electric Power Company's coal-fired plant at Mt Storm, West Virginia. 

Source: http :llwww.oag.st ate.ny .us/press/2000/nov/nov 16a _ 00 _pictures.h tml 
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U.S. Environmental Protection Agency 

Office of Inspector General 

At a Glance 

2005-P-00003 

February 3, 2005 

Additional Analyses of Mercury Emissions Needed 

Before EPA Finalizes Rules for Coal-Fired Electric Utilities 

What We Found 

Evidence indicates that EPA senior management instmcted EPA staff to develop a 

Maximum Achievable Control Technology (MACT) standard for mercury that 

would result in national emissions of 34 tons annually, instead of basing the 

standard on an unbiased determination of what the top performing units were 

achieving in practice. The 34-tons-per-year target was based on the amount of 

mercury reductions expected to be achieved from implementation of nitrogen oxide 

(NOx) and sulfur dioxide (SO,) controls under a separately proposed, but related, 

air rule. According to EPA officials, 34 tons represents the most realistic and 

achievable standard for utilities. However, because the results of the MACT 

standard were prescribed and prior estimates were lower than what was proposed, 

the standard likely understates the average amount of mercury emissions reductions 

achieved by the top performing 12 percent of utilities, tllC minimum level for a 

MACT standard required by the Clean Air Act. Further, this MACT standarJ, as 

proposed, does not provide a reasonable basis for determining whether the MACT 

or cap-and-trade approach provides the better cost benefit 

The Agency's cap-and-trade proposal can be strengthened to better ensure that 

anticipated emission reductions would be achieved. For example, utilities would 

not need to install mcrcury~spccific controls to achlevc the interim cap, but could 

meet the cap by implem.enting NOx and S02 controls associated with another 

proposed trading program, Also~ the proposal docs not adequately address the 

potential for hot spots. Further, provisions for units emitting small amounts of 

mercury could be improved. 

We also tbund that EPA's rule development process did not comply with certain 

Agency and Executive Order requircmentsj including not fuUy analyzing the costbenefit of regulatory alternatives and not fully assessing the rule's impact on 

children's health. 

What We Recommend 

We recommend that EPA re-analyze mercury emissions data collected for the top 

pertbm1ing 12 percent of units to develop a MACT floor. The Agency should also 

conduct a revised cost-benefit analysis for the updated MACT that takes into 

account the impact of mercury co-benefits achieved through the proposed Clean Air 

Interstate Rule. The results of the cost-benefit review should be compared to the 

cost~benefit of the proposed cap~and-tradc option to detennine the most cost 

beneficial option tor controlling mercury emissions. We also recommend that EPA 

strengthen its cap-and-trade proposal by more fully addressing tl1e potential tor hot 

spots~ revising the safety valve proposal so that it is used only as intended during 

periods of unanticipated market volatiHty; and revising the proposed exemption for 

small emitters. Further, we recomrnend (hat the Agency conduct more in-depth 

analyses Dfthe regulatory alternatives and children's health impacts as required by 

Executive Orders. The Agency's response to the draft report did not specifically 

address our reconnncndations, but raised concerns about certain aspects ofthe 

report. 
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MEMORANDUM 

SUBJECT; 

TO; 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

THE INSPECTOR GENERAL 

February 3, 2005 

Evaluation Report Additional Analyses of Mercury Emissions Needed 

Before EPA Finalizes Rules for Coal-Fired Electric Utilities 

Report No. 2005-P-00003 

Jeffrey R. Holmstead 

Assistant Administrator for Air and Radiation 

This memorandum transmits the results of an Oftlce of Inspector General (OIG) evaluation 

regarding the Environmental Protection Agency's (EPA) development of the proposed rule for 

regulating mercury emissions from coal-fired steam generating electric utility units. This report 

cnntains findings that should help EPA in its efforts to develop the final rule. Also, the report 

contains corrective actions the Otlice of Inspector General (OIG) recommends. This report 

represents the opinion of the OIG and the findings contained in this report do not necessarily 

represent the final EPA position. Final determinations on matters in this report will be made by 

EPA managers in accordance with established procedures. 

Action Required 

In accordance with EPA Directive 2750, as the action official, you are required to provide this 

Otllce with a written response within 90 days of the final report date. The response should 

address all recommendations. For the corrective actions planned but not completed by the 

response date, please describe the actions that are ongoing and provide a timetable for 

completion. Where you disagree with a recommendation, please provide alternative actions for 

addressing the findings reported. 

We appreciate the efforts of EPA officials and staff in working with us to develop this report. If 

you or your stall' have any questions regarding this report, please contact me at (202) 566-084 7 

or Kwai Chan, Assistant Inspector General for Program Evaluation, at (202) 566-0827. 

L 

Nikki L. Tinsley 
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Attachment 

cc: Steve Johnson, Acting Administrator 

William Farland, Acting Deputy Assistant Administrator for Science, ORD 

Ann Klee, General Counsel 

Pete Cosier, Audit Followup Coordinator, OAR 

Kwai Chan, Assistant Inspector General for Program Evaluation, OIG 

Mark Bialek, Counsel, OIG 
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Table of Contents 

At a Glance 

Chapters 

Introduction ..................................................... . 

Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 

Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 

Scope and Methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 

Results in Brief . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 

2 Mercury MACT Development Compromised . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 

Requirements for MACT Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 

EPA's Process for Addressing Variability in Computation 

of Mercury MACT Floor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 

EPA Staff Instructed to Develop MACT Floor That Would Result in 

National Emissions of 34 Tons .............................. 13 

Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 

Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 

Agency Comments and OIG Evaluation ............................. 16 

3 Cap-and-Trade Option Can Be Strengthened . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 

EPA's Proposed Cap-and-Trade Approach . . . . . . . . • . . . . . . . . . . . . . . . . . 18 

Proposed Cap-and-Trade Program Needs to Further Address 

Certain Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 

Proposed Emissions Trading Rule Should Also Address Tribal Concerns . . . 24 

Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 

Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 

Agency Comments and OIG Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 

4 Rule Development Process Not Consistent with 

Expected and Past Practices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 

Description of Rulemaking Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 

Some FACA Members Considered Job Unfinished . • . . . . . . . . . . . . . . . . . . 28 

Intra-Agency Review Limited . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 

Requirements for Cost-Benefit Analyses Not Fully Implemented . . . . . . . . . . 32 

Required Children's Health Analysis Not Completed . . . . . . . . . . . . . . . . . . . 33 

Scope Limitations: Inter-Agency Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 

Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 

Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 

Agency Comments and OIG Evaluation ............................. 35 
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Appendices 

A Time line of Events Related to Development of Mercury Rule . . . . . . . . . . 37 

B OIG's Request for Documents Related to Development 

of Utility MACT . . . . . . . . . . . . . . . . . . • . . . . . . . . . . . . . . . . . • • . . . • . . . . . . 39 

C Different MACT Floor Proposals . . . • . . . . . . . . . . . • . . . . . . . . • . . • . . . . . 43 

D EPA's Rule Development Process ..................•..•.......... 44 

E Agency Comments to the Draft Report and OIG Evaluation . . . . • • • . . . . 46 

F Distribution • . . . . • . . . . . . . . . . . . . . . . . • . . . . . . . • . . . . . • . . . . • . . . . . . . 54 
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Purpose 

The Office of Inspector General (OIG) initiated this review based on a request 

from members of the Senate Environment and Public Works Committee. In their 

written request, the Senators expressed concerns with the process used to develop 

the Environmental Protection Agency's (EPA's) January 2004 proposed rule for 

regulating mercury emissions from coal-fired steam generating electric utility 

units. The proposed rule included two different options for regulating mercury 

emissions. One approach was a Maximum Achievable Control Technology 

(MACT) standard that would establish emission limits applicable to all coal-fired 

utility units. The other approach was a mercury cap-and-trade approach that 

would establish a national cap on mercury emissions and allow individual utilities 

to trade emissions allowances in a market-based system. The objectives of our 

evaluation were to determine: 

Do the data and analyses in the docket demonstrate that the proposed MACT 

option reflects the maximum achievable reductions from coal-fired steam 

generating electric utility units? 

Is the mercury cap-and-trade option, as proposed, sufficient to ensure public 

health protection? 

What process did EPA follow in developing the proposed rule, and was this 

process consistent with applicable statutes, regulations, policy, guidance, and 

past Agency practice? 

Background 

Mercury is released globally into the environment through natural processes, such 

as volcanoes, and also from human activity. Man-made releases of mercury are 

primarily due to the burning of mercury-containing fuels and wastes, and through 

industrial manufacturing processes. Man-made mercury emissions from the 

United States are estimated to account for roughly 3 percent of total global 

mercury emissions. Mercury from lead smelters, municipal waste combustors, 

hospital waste incinerators, manufacturing operations, and other sources are 

largely already regulated by EPA. In the United States, the largest source of 

airborne mercury emissions is the coal-burning electric utilities industry, 

representing an estimated 40 percent of total U.S. man-made airborne mercury 
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emissions. EPA has estimated that one-third of all U.S. emissions of mercury are 

deposited within the contiguous United States, while the remaining two-thirds 

enter the global cycle. The January 2004 proposal is the first attempt to regulate 

mercury emissions from these utilities at the Federal level. 

Airborne concentrations of mercury are generally considered to be small and not a 

serious health concern while still in the air. However, once mercury enters freshwater and salt-water bodies, either directly or through air deposition, it can 

bioaccumulate in fish and other animal tissues in its more toxic fonn, 

methylmercury. As mercury bioaccumulates in the food chain, its concentration 

becomes increasingly higher in animals at the top of the food chain (such as larger 

predatory fish) that consume smaller contaminated organisms. Because of the 

bioaccumulation of methylmercury, the primary route of human exposure to 

mercury is through the consumption of fish, both salt water and fresh water. 

Excessive human exposure to mercury has been associated with severe 

detrimental neurological and developmental health effects. Depending on the 

dose, human health effects from exposure to mercury can include subtle losses of 

sensory and cognitive ability, tremors, inability to walk, and death. The 

developing fetus may be particularly sensitive to the detrimental effects of 

methylmercury; thus, exposure to mercury by women of child-bearing age is of 

particular concern. 

From a global perspective, mercury accumulation in salt-water fish is a public 

health concern. EPA and the Food and Drug Administration have cautioned that 

young children, as well as women who might become pregnant, are pregnant, or 

are nursing should limit their consumption of certain salt-water predatory fish. 

Mercury bioaccumulation in U.S. water bodies is also a public health concern, and 

45 States issued fish advisories for mercury in 2003. Many of these fish 

advisories caution that women and young children should limit their consumption 

of certain types of fish. 

EPA Reference Dose for Methylmercury 

Based on studies showing adverse health effects from exposure to methylmercury, 

EPA set a reference dose for methylmercury that was designed to protect the most 

sensitive subgroup (i.e., developing fetuses). An EPA reference dose reflects the 

estimate of daily exposure to the human population, including sensitive 

subgroups, that is not likely to cause harmful effects during a lifetime. The 

current EPA reference dose for methylmercury which was included in EPA's 

1997 Mercury Study Report to Congress is 0.1 micrograms per kilogram of 

body weight per day. 

2 
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Subsequent to EPA's 1997 Mercury Study Report to Congress, Congress directed' 

EPA to request the National Academy of Sciences to perform an independent 

study on the toxicological effects of methylmercury and to prepare 

recommendations on the establishment of a scientifically appropriate exposure 

reference dose. The National Academy of Sciences completed its review in 2000, 

and concluded that the EPA reference dose of 0.1 micrograms per kilogram was a 

scientifically justifiable level for the protection of health. 

The most recent results from Centers for Disease Control and Prevention's 

ongoing National Health and Nutrition Examination Survey show that mercury 

blood levels of most children and women of childbearing age were below levels of 

concern corresponding to the EPA reference dose. However, 5.66 percent of 

childbearing-aged woman had blood mercury levels at or above the reference 

dose. The survey also questions participants about their fish consumption. For 

the 1999-2000 survey period, tuna and shrimp were the two most frequently cited 

types of fish/shellfish consumed. These results, and other studies, suggest that 

seafood (as opposed to fresh-water fish) is the predominant source of mercury 

exposure in the United States. However, some subpopulations in the United 

States consume more fish, including fresh-water fish, than the general population. 

These groups may be at increased risk from mercury exposure. For example, 

studies have shown elevated blood levels of mercury in some Native American 

tribes that consumed fresh-water fish. 

Statutory Requirements for Controlling Mercury Emissions from 

Utility Plants 

The Clean Air Act (CAA) requires EPA to regulate emissions of 188 air taxies 

(also known as hazardous air pollutants), including mercury. EPA was to 

identify and establish emission standards for major source categories emitting 

these pollutants. Specifically, section 112( d) of the CAA requires EPA to 

establish emission limits for major source categories emitting air taxies, 

commonly referred to as MACT standards. The MACT standard is to require the 

maximum degree of reductions achievable for the source category, taking into 

consideration cost and any non-air quality health and environmental impacts. 

A key requirement of section 112( d) is that emission standards for existing 

sources in a category or subcategory shall not be less stringent than the average 

emission limitation achieved by the best performing 12 percent of the existing 

sources for which the Administrator has data. The emission limitation achieved 

by the best performing 12 percent of sources is referred to as the "MACT floor." 

1 H.R. Rep. No. 769, 105'" Cong., 2d Sess. at 281-282 (1998). This is the Conference Report to accompany 

H.R. 4194, October 5, 1998. 

3 
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The CAA also established specific requirements with respect to air taxies 

emissions from utilities. Section 112(n)(I)(A) requires EPA to perform a study of 

the hazards to public health that are reasonably anticipated to occur as a result of 

air taxies emissions from electric utility steam generating units. This study was to 

develop and describe alternative control strategies for emissions that may warrant 

regulation under section 112. Further, with respect to regulating emissions from 

utility plants, section 112(n)(I )(A) states: 

The Admin[~trator shall regulate electric utility steam generating units 

under this section, if the Administrator finds such regulation is 

appropriate and necessary after considering the results of the study 

required by this subparagraph. 

EPA published its Final Report2 with respect to utilities in February 1998, but 

deferred making a determination as to whether regulation of these units was 

appropriate and necessary. However, the Final Report concluded that: 

Mercury from coal-fired utilities was the air pollutant of greatest potential 

concern to public health from utilities; 

Coal-fired utilities are estimated to emit about one-third (51 tons based on 

1994 emissions) of U.S. anthropogenic (man-made) mercury emissions per 

year; 

Ingestion of contaminated fish is the most important route of exposure to 

mercury; and 

Modeling in conjunction with the available scientific data provides evidence 

for a plausible link between emissions of mercury from utilities and the 

methylmercury found in soil, water, air, and fish. 

In its Final Report, EPA listed a number of research needs related to mercury 

emissions. These included obtaining additional data on mercury emissions, such 

as the amount emitted from various types of units; the proportion of divalent 

versus elemental mercury; 3 and how factors such as the control device, fuel type, 

and plant configuration affect emissions and speciation. 

2 Study of Hazardous Air Pollutant Emissions from Electric Utility Steam Generating Units ~ -Final Report 

to Congress, EPA-453/R-98-004a, February 1998. 

3 Airborne diValent mercury is adsorbed onto particles or bound to other compounds and is deposited 

sooner and mainly in the vicinity of the emissions sources (local to regional distances), while elemental mercury 

(vapor) remains airborne longer and is transported on a hemispherical/global scale. 

4 
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80 tests. 

Information Collection Request 

Based on the research needs outlined in the Final Report, the then-EPA 

Administrator concluded that obtaining additional information from 

owner/operators of coal-fired electric utility steam generating units was needed to 

determine whether regulation of electric utility steam generating units was 

appropriate and necessary. Accordingly, EPA used its authority under CAA 

section 114 to collect data from all domestic coal-fired electric utility steam 

generating units. The resulting information collection request (ICR) consisted of 

three phases of data collection: 

Phase I collected general information on every coal-fired electric generating 

utility unit and was completed in January 1999. 

Phase II consisted of obtaining information on the amount of coal received on 

a per shipment basis for the 1999 calendar year for every facility. In addition, 

the mercury and chlorine content of the coal was reported for every sixth 

shipment. 

Phase III consisted of emissions testing at 80 units,' which were selected to 

represent a cross-section of boiler and rontrol device types. For each of the 

80 units selected, testing for mercury was conducted at the inlet and outlet of 

the last pollution control device on the unit. Each unit was to conduct three 

separate test runs and to also sample and analyze the coal used during each of 

the three separate runs. 

December 2000 Findings and Determination 

In a December 20, 2000, Federal Register Notice, EPA published its finding that 

regulation of mercury emissions from coal-fired utility plants was appropriate and 

necessary. The notice described four primary sources of information for the 

finding: 

EPA's February 1998 "Study of Hazardous Air Pollutant Emissions from 

Electric Utility Steam Generating Units-- Final Report to Congress." 

An ICR to all coal-fired electric utility steam generating units requesting coal 

data for 1999 and a request to certain units for stack test results to evaluate air 

toxics emissions. 

An evaluation of the mercury control performance of various emission control 

technologies currently in use to control other pollutants or that could be 

applied to such units to control mercury emissions. 

4 Emission tests were actually conducted at 79 different units with 2 tests conducted at 1 unit for a total of 

5 
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An evaluation of available health data related to mercury conducted by the 

National Academy of Sciences. 

The Notice concluded that," ... during the regulatory development process, 

effective controls for mercury and other HAPs (hazardous air pollutants) can be 

shown to be feasible." The Notice recognized the considerable interest in using 

economic incentive programs, such as emission trading, to achieve emission 

reductions. However, in its December 2000 notice, EPA cited concerns about the 

potential local impact of emissions trading and noted that any trading program 

must be constructed in a way that assured communities nearest a source were 

adequately protected. The Notice stated: 

Thus, in developing a standard for utilities, the EPA should consider the legal 

potentia/for, and the economic effects of, incorporating a trading regime 

under section 112 in a manner that protects the local populations. 

After issuance of these findings and its determination that regulation of utilities 

was appropriate and necessary, EPA began to develop a MACT standard for 

mercury emissions from coal-fired electric utility units. Additionally, a 

workgroup was established in August 2001 under the Clean Air Act Advisory 

Committee to provide EPA with input regarding Federal MACT regulations for 

coal-fired electric utility steam generating units. Appendix A provides a timeline 

of events associated with the development of the MACT rule. 

Clear Skies Proposal 

Concurrent with EPA's initial efforts to develop a MACT for utility units, 

legislation was proposed in Congress' to establish a multi-pollutant approach for 

addressing mercury, sulfur dioxide {S02), and nitrogen oxide (NOx) emissions 

from utilities. This legislation, referred to as Clear Skies, proposed a cap-andtrade approach to controlling emissions of these three pollutants. With respect to 

mercury, the initial Clear Skies legislation called for an interim cap on total U.S. 

mercury emissions of26 tons per year by 2010. Based on modeling done in 

support of the Clear Skies Proposal, EPA estimated that some facilities would 

install mercury-specific technology by 20 I 0 in order to meet the 26-ton cap. 

Clear Skies proposed a final cap of 15 tons on mercury emissions by 2018, and 

EPA analysis projected that additional sources would choose to install mercuryspecific controls to meet the cap. 

When Clear Skies legislation stalled in Congress, EPA decided to propose a capand-trade approach for controlling mercury emissions as an alternative to a 

5 Clear Skies was proposed in both the U.S. House of Representatives and Senate in July 2002, and 

reintroduced as the Clear Skies Act of 2003 on February 27, 2003. 

6 
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27172.689

MACT standard. EPA proposed these regulatory alternatives in the January 30, 

2004, Federal Register Notice. In addition to the proposed mercury rule 

alternatives, EPA on January 30, 2004, also proposed new air rules for reducing 

SO, and NOx emissions. This proposed rule, now known as the Clean Air 

Interstate Rule (CAIR), would establish a cap-and-trade program for 29 States in 

the Eastern United States and the District of Columbia whose SO, and NOx 

emissions significantly contribute to fine particle and ozone pollution problems in 

other downwind States. Together, the CAIR and mercury proposals would create 

a multi-pollutant approach to controlling emissions from utilities similar to what 

was originally proposed in the Clear Skies legislation. 

Proposed Mercury Rule 

As a result of a prior court settlement6

, EPA had agreed to issue proposed power 

plant mercury emission standards by December 15, 2003. In the January 30, 

2004, Federal Register Notice, EPA proposed its rule for regulating mercury 

emissions from coal-fired steam generating electric utility units. This proposal 

includes two different approaches for controlling mercury emissions from utilities: 

a MACT standard or a mercury cap-and-trade program. 

EPA's Proposed MACT Standard Approach: EPA proposed separate emission 

limits to be achieved by 2008 for five subcategories: three subcategories for 

different coal types (bituminous, sub-bituminous, and lignite); one for coal refuse 

or waste; and one for a specific type of combustion process known as Integrated 

Gasification Combined Cycle (IGCC). 7 Table 1-1 shows the specific per unit 

emissions limits for existing units in the proposed rule. 

Table 1-1: Proposed MACT Emission Limits 

Bituminous 2.0 

5.8 

lianite 9.2 

Coal-Refuse 0.38 

IGCC 19.0 

* = pounds per Tnllion Bntlsh thermal units. 

These emission limits were based on what EPA determined to be the MACT 

floor. EPA proposed that the MACT standard be based on the MACT floor as 

6 Under a settlement agreement reached in 1998 with the Natural Resources Defense Council, EPA agreed 

to issue a proposed rule for regulating mercury from power plants by December 15, 2003, and a final rule by 

December 2004. (Natural Resources Defense Council v. EPA,D.C. Cir., No. 92-1415, 4/15/98). Natural Resources 

Defense Council later agreed to extend the deadline for the final rule to March 15, 2005. 

7 The IGCC process converts coal into gas and uses the coal gas as fuel for generating electricity. 

7 
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27172.690

opposed to a beyond-the-floor' level because it concluded that technologies for 

reducing mercury emissions were not commercially available and, thus, beyondthe-floor emission standards were not achievable. EPA estimated that total 

national mercury emissions would be reduced from 48 to 34 tons per year if the 

proposed MACT rule was implemented. 

EPA's Proposed Cap-and-Trade Approach. In lieu of adopting a MACT 

standard to regulate mercury emissions from utilities, EPA presented an 

alternative proposal that would regulate mercury emissions from utility units 

under a national cap-and-trade program implemented under section Ill of the 

CAA! The cap-and-trade proposal included an unspecified interim cap on 

mercury emissions in 2010 and a final cap of 15 tons by 2018. Though EPA did 

not specify an interim cap level, the Agency proposed that it be based on the 

maximum amount of mercury reductions that could be achieved through 

implementing the controls necessary to reduce S02 and NOx emissions, i.e., the 

mercury co-benefit of these controls through implementation of CAIR. The 

preamble to the rule states that EPA modeling indicated an expected co-benefit 

level, which is the result of implementing the CAIR rule, resulting in mercury 

emissions of 34 tons per year. EPA also took comment on administering the capand-trade approach under CAA section 112 instead of section 111.10 The primary 

difference between these two approaches is that a section 112 cap-and-trade 

program would be administered centrally by EPA while the section Ill program 

would be administered individually by States. 

Scope and Methodology 

We conducted our field work from May 2004 through December 2004, and did so 

in accordance with Government Auditing Standards, issued by the Comptroller 

General of the United States. We performed field work in EPA's Office of Air 

and Radiation locations in Washington, DC, and Research Triangle Park, North 

Carolina. We interviewed staff from EPA offices and outside organizations to 

gain an understanding of the rule as developed, other options considered, and the 

rule development process. We interviewed officials from EPA's Office of Air 

and Radiation; Office of Research and Development; Office of Enforcement and 

Compliance Assurance; and Office of Policy, Economics, and Innovation. We 

also contacted environmental and utility industry representatives, and State, local, 

and tribal organizations interested in the development of this proposed rule, to 

8 A MACT standard more stringent than the tloor is referred to as "beyond~the-floor." 

9 Concurrent with this approach, EPA proposed to revise its December 2000 finding that regulating utilities 

under section 112 was necessary and appropriate. 

10 This approach would not require EPA to revise its December 2000 finding, but would require EPA to 

.. de-list" utilities as a source category requiring a MACT standard. 

8 
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27172.691

obtain their views. We reviewed data and analyses developed in support of the 

rule, and public comments included in the rulemaking docket. We also reviewed 

related information provided by both EPA and non-EPA officials contacted. 

The Government Accountability Office is conducting a review of technologyrelated issues for the proposed mercury rule, which is an important consideration 

in determining whether the MACT standard can be set at a level that is more 

stringent than the floor. The Government Accountability Office report was not 

available in December 2004 for consideration in the OIG report. 

Limitations 

Our evaluation was conducted and completed before the Agency had completed 

the rulemaking process. Accordingly, our observations and characterizations 

about the process reflect the status of the rulemaking process at the time we 

completed our review. Issuance of the final rule is planned for March !5, 2005, 

and the final rule may consider additional information or analyses not available at 

the time we completed our review. For example, EPA released a notice of data 

availability for the proposed Clean Air Mercury Rule on December I, 2004. The 

notice requests additional public comment on issues addressed in this report, and 

solicits further comment on new data and information to help EPA evaluate which 

regulatory approach will best reduce mercury emissions from power plants. We 

did not specifically consider the notice because it was released after we had 

completed our review and analyses. However, the notice includes information 

available previously in the public comment docket for this rule, and it is possible 

we had considered some of that infom1ation during our review. 

The OIG was not provided with several important documents it requested from 

the Agency; therefore, that information was not available for consideration in this 

report. Our memorandum detailing the requested information, as well as specifics 

on what information was provided by the Agency, are provided in Appendix B. 

Consideration of the inter-agency review process was limited to information from 

EPA staff and information available in the docket only. We were not able to 

discuss the inter-agency review process with Office of Management and Budget 

(OMS) staff who were responsible for coordinating the inter-agency review 

process. The OIG did not independently analyze the databases or computer 

modeling programs that EPA used in developing the proposed rule. With respect 

to the development of the MACT standard, the OIG did not attempt to 

independently calculate the MACT floor. 

9 
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27172.692

Results in Brief 

Evidence indicates that EPA senior management instructed EPA staff to develop a 

MACT standard for mercury that would result in national emissions of 34 tons 

annually, instead of basing the standard on what the top performing units were 

achieving in practice. Also, we determined that EPA's mercury cap-and-trade 

proposal - a nationwide emissions trading program for an air toxic- can be 

strengthened to better ensure that human health is protected and anticipated 

emission reductions achieved, should this approach to reducing mercury 

emissions be adopted. Further, although EPA rulemaking procedures are not 

consistently applied, Agency staff told us that they would have expected greater 

adherence to the guidance for mercury rule development due to the significance of 

this particular regulatory action, but this did not happen. 

We recommend that EPA re-analyze mercury emissions data collected, and 

conduct a revised cost-benefit analysis for the updated MACT that takes into 

account the impact of mercury co-benefits achieved through the proposed CAIR. 

We also recommend that the Agency strengthen its cap-and-trade proposal. 

Further, we recommend that the Agency conduct an integrated analysis with 

respect to whether emissions reductions under either of these proposals are the 

most child-protective, timely, and cost-effective. 

The Agency disagreed with certain aspects of our draft report, and offered 

suggested changes or revisions. The Agency's response did not specifically 

address our recommendations. We made changes to the final report based on the 

Agency's comments, as appropriate. See Appendix E for the full text of the 

Agency's official comments to our draft report and our response to these 

comments. 

10 
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Evidence indicates that EPA senior management instructed EPA staff to develop a 

MACT standard for mercury that would result in national emissions of 34 tons 

annually, instead of basing the standard on an unbiased calculation of what the top 

perfonning units were achieving in practice. The CAA requires that a MACT 

standard should, at a minimum, be based on the emissions levels achieved by the 

top performing 12 percent of units, not a targeted national emissions result. The 

34-tons-per-year target was based on the co-benefits expected to be achieved from 

implementation ofNOx and S02 controls under the proposed CAIR. EPA noted 

that this target was based on extensive analysis and, in EPA's judgment, 

represented the lowest level of mercury emissions that it could reasonably expect 

the utility industry to achieve. 

Because the results of the MACT standard were prescribed and prior estimates 

were lower than what was proposed, we believe it likely that the standard 

understates the average amount of mercury emissions reductions achieved by the 

top performing 12 percent of power units. Some Agency officials told us that, in 

their opinion, the true MACT floor would result in lower mercury emissions than 

the 34 tons estimated from current MACT floor limits. Therefore, if this proposed 

MACT standard was adopted, it would not achieve the maximum emission 

reductions achievable and the associated health benefits. Further, this MACT 

standard, as proposed, does not provide a reasonable basis for comparison in 

determining which of EPA's two proposed regulatory alternatives (i.e., the MACT 

standard or the mercury cap-and-trade program) provides the better cost-benefit. 

Requirements for MACT Standards 

In accordance with the CAA, EPA is to establish MACT standards that require 

the maximum emissions reductions the Agency believes are achievable for a 

major source category. At a minimum, the MACT standard cannot be less stringent 

than the average emission reductions achieved by the top performing 12 percent of 

units in a category (e.g., all coal-burning utilities) or subcategory (e.g., utilities 

burning bituminous coal) for which the Administrator has data. EPA has wide 

latitude in the types of emissions data used to determine the MACT floor, 

including the discretion to select a reasonable method to estimate emissions 

achieved, and to address variability to account for the most adverse operating 

conditions reasonably foreseeable. If EPA decides to set a limit beyond the floor, 

it must consider the cost of achieving those reductions, any resulting non-air 

quality and environmental impacts, and energy requirements. 

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In accordance with a court settlement, EPA had agreed to publish its final mercury 

rule by December 15, 2004. This date was re-negotiated with the court petitioner 

and the final rule deadline was extended to March 15,2005. 

EPA's Process for Addressing Variability in Computation of 

Mercury MACT Floor 

As provided underCAA section 112(d), EPA first determined whether a MACT 

standard should be developed for all coal-fired units or sub-categories. EPA 

analyzed the ICR data and identified the top performing units from all units for 

which emissions data were collected. Evaluation of the ICR data for the top 

perfonning units focused on coal type, plant processes, and control technology. 

EPA could not identify a common attribute that contributed to mercury emission 

reductions for all of tbe top performing units that would allow development of a 

single MACT emissions limit for all units. Additionally, it was determined that 

no units had installed mercury-specific control technology, although controls 

installed to reduce emissions of other pollutants also helped reduce mercury 

emissions. When no single common factor was identified, EPA evaluated the 

data further and detennined that sub-categorization by coal type, which is also a 

driving factor in plant design, was warranted to establish the MACT. One 

additional sub-category was established for a particular plant type -Integrated 

Gasification Combined Cycle because the plant bums gas from coal rather than 

any particular type of coaL 

For each sub-category, EPA identified the top performing units based on emission 

tests collected during the ICR. However, EPA determined that these emission 

tests alone did not sufficiently estimate the effect of fuel variability over time on 

the emissions of the best performing units. To account for this variability, EPA 

used coal composition data (i.e., mercury and chlorine content) for coal shipments 

collected during the ICR to estimate emissions throughout the year for the top 

performing units in each subcategory. This increased the number of emission 

points available from which to calculate the MACT limits. u 

The emission points for each of the top performing units were ranked and then 

EPA selected one of the highest emissions points (i.e., the 97.5 percentile) for 

each unit. According to EPA, this emission point reflects the best performance 

under tbe worst foreseeable operating conditions for the unit. EPA took the 

average of these selected emission points for each sub-category and adjusted this 

11 Prior court cases have upheld EPA's right to consider variability in developing MACT floors. For a 

discussion of the appropriateness of EPA's efforts to account for variability, see Cement Kiln Recycling Coalition v, 

Envt'l Protection Agency, 255 F.3d 855 (D.C.Cir. 2001), examining, SieFra Club v. Envt'l Protection Agency, !67 

F.3d 658 (D.C.Cir.!999) and National Lime Ass'n v. Envt'l Protection Agency, 233 F.3d 625,629 (D.C.Cir.2000) 

("National Lime II"). 

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average to further account for variability (i.e., the 97.5 percent upper confidence 

level of the average). This adjusted average was established as the MACT floor 

and the proposed standard for each subcategory. 

Unlike many previous MACT standards, the proposed utility MACT standard 

would not require the installation of a specific control technology since no 

mercury-specific control technology had been installed in utilities. EPA 

determined that emerging mercury-specific technologies were not yet 

commercially available for the utility industry. The Government Accountability 

Office is conducting a study to assess the current state of mercury control 

technology. 

EPA Staff Instructed to Develop MACT Floor That Would Result in 

National Emissions of 34 Tons 

Evidence indicates that EPA staff were instructed to develop a MACT standard 

that would result in national emissions of34 tons per year. Some staff told us that 

they heard these specific directions and others told us that they heard in different 

meetings during rule development that the application of the MACT floor to 

utilities should equal 34 tons per year (a 29-percent reduction from the present 

48-tons emitted nationwide). These statements were further corroborated by 

internal EPA e-m ails, which specifically identified 34 tons per year as the number 

desired despite the fact that prior modeling results did not result in 34 tons. 

E-mails between EPA staff discussed various MACT emission limits by 

subcategory and modeling scenarios that could be used to get closer to the 34 tons 

target. For example, a November 2003 e-mail stated that: 

If the 14 +K of subbit A CI is using the 90% option and we restrict this to 

60%, perhaps we can get in the 34 tpy range. I don't think that restriction 

would be considered inappropriate for a 2007 MACT analysis. 

EPA documents and an analysis of the process used to compute the MACT floor 

support EPA staff's statements that the MACT floor computations were 

developed to produce the desired national emissions of 34 tons per year. 

Documentation that we reviewed indicated that EPA conducted at least three 

Integrated Planning Model (IPM) 12 runs in order to reach the pre-determined 

target for national mercury emissions of 34 tons. The initial IPM run to try to 

reach the 34-tons target yielded a national emission of 29 tons (i.e., the IPM 

model indicated that mercury could be reduced from48 tons to 29 tons). After 

changing the proposed MACT emission limits, a second IPM model yielded a 

12 EPA uses ICF Resources Incorporated's Integrated Planning Model for air emission modeling. The 

model projects what decisions utilities would make for meeting air emission regulations based on economic 

considerations. 

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national emission of 27 tons. While we were provided summary infonnation 

about these two IPM model runs, they were not included in the EPA rulemaking 

docket. 

An Agency source indicated that these results were not acceptable to senior 

management because they were not close enough to the 34-tons target. A third 

run performed, based on the proposed emission limits, showed 31 tons. EPA 

cited the 31-tons model results in the proposed rule, but explained in the preamble 

that 34 tons is the more probable emissions level because the model used to 

estimate emissions was underestimating the amount of mercury emissions that 

would occur. EPA noted that the IPM model may have understated mercury 

emissions by 2.3 tons for units burning bituminous coal. 13 Table 2-1 depicts the 

emission limits used in the three IPM runs and the resulting total national 

emissions: 

Table 2-1: Results of Proposed MACT Scenarios to Reach 34 Tons 

Bituminous 0.57. 1.4. 1.9679. 

Sub-bltumll)pus 6.46' 5.06. 5.8. 

Lignite 18.45. 19.48 • 9.2. 

Total National Mercury 29-30 •• 27.2-27.9 .. 30-31 .. Emissions (tons-per-year) 

Proposed per unit mercury emission standard expressed in pounds per trillion British thermal 

units (lbfTBtu). 

Estimated tons of national mercury emission resulting from modeling the application of the 

unit emission standard to all utility units. 

The emission limits shown in Run #3 above, ultimately proposed as the MACT 

standard, were based on a multi-variability analysis submitted by WEST 

Associates (a western utility consortium)." However, EPA adjusted this 

approach, increasing the MACT floor emission limits for two of the three 

subcategories beyond those derived by WEST Associates. For example, WEST 

Associates used an upper confidence level of95 percent of the mean of the best 

perfonning units to account for variability. EPA adjusted the confidence level to 

13 The IPM model only allows Activated Carbon Injection technology, a mercury specific control 

technology, to reduce mercury emissions at 60% and 90% levels. The inability of the model to address the full range 

of reductions berween these two levels means that the model may have understated mercury emissions by as much as 

2.3 tons for bituminous~fired units. 

14 The analysis was submitted during the last Federal Advisory Committee Act meeting, convened in 

March 2003. 

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97.5 percent, which resulted in an increase in the emission limit for two of the 

three sub-categories. According to EPA's variability analysis, this adjustment was 

made to account for EPA's interpretation of the number ofunits that should be 

included in the MACT floor analysis." These adjustments increased the MACT 

floor closer to a national emission level of 34 tons per year. 

Relationship of the 34-Ton Estimate to Cap-and-Trade Proposals 

The 34-tons-per-year target is important because it is based on mercury emission 

modeling results used in two separately proposed cap-and-trade programs for 

utilities- CAIR and the mercury cap-and-trade program proposed as 

alternatives to the mercury MACT. EPA has stated its intent to implement its 

multi-pollutant (mercury, SO,, and NOx) cap-and-trade programs, originally 

included in stalled Clear Skies legislation, through the proposed CAIR and 

mercury regulations. 

EPA has also proposed that the mercury reductions gained from implementing 

CAIR should serve as the interim cap on mercury emissions in the mercury capand-trade program. According to the preamble to the mercury rule, the reason for 

basing the interim cap on the co-benefits from CAIR is that the Agency does not 

believe mercury control technology that has been demonstrated for all coal types 

is commercially available. In addition, Agency officials stated that the 

34-tons-per-year target was based on the co-benefits expected to be achieved from 

implementation of NOx and SO, controls under the proposed CAIR. They noted 

that this target was based on extensive analysis and, in EPA's judgment, 

represents the lowest level of mercury emissions that they could reasonably expect 

this industry to achieve by 2010. 

Additional Estimates of Mercury Emissions 

Interviews with sources both inside and outside the Agency suggest that if 

unbiased analyses of data were conducted, a range of possible MACT floor levels 

would most likely result. One EPA official stated that the true range of possible 

MACT floors was probably as low as 8 to 10 tons per year up to the mid-20s, but 

that either end of that range would be a stretch. Further, the source stated that the 

real range is about 15 tons per year to the low 20s for this MACT, and that 

anything above or below those numbers was a stretch. This includes the 34 tons 

proposed by the Agency. These statements about the possible range ofMACT 

floors are supported by results of different MACT floor limits and/or varying 

model assumptions used by some organizations providing comments to the 

15 For example, West Associates used 5 units for each sub-category, while EPA used 4 units for the 

bituminous and sub-bituminous sub-categories and 5 units for lignite sub-category. 

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proposed rule. For example, the Clean Air Task Force evaluated the ICR data to 

develop MACT floor limits that were different than those developed by EPA. 

Applying these limits to the same IPM model used by EPA resulted in national 

mercury emissions of 12 tons 16 (i.e., a 75-percent reduction from 48 tons). 

Modeling by the Electric Power Research Institute and Edison Electric Institute 

used the MACT floor limits proposed in the rule and showed an estimated 32 tons 

of mercury emissions nationwide (i.e., a 33-percent reduction from 48 tons). 

Examples of varying modeling efforts and results can be found in Appendix C. 

Conclusions 

EPA's current estimate of the amount of mercury emissions occurring after 

implementing SO, and NOx controls, called for in EPA's CAIR, is 34 tons. 

Given (I) that EPA is attempting to implement the Clear Skies multi-pollutant 

approach through regulation; (2) the numerous modeling runs conducted to 

determine national emission resulting from different MACT emission limits; 

(3) the adjustments made in the accounting for variability; ( 4) the statements of 

EPA officials involved in the mlemaking process; and (5) EPA e-mails reviewed, 

we believe EPA's approach for developing the MACT floor was compromised. 

Further, it is unlikely that an unbiased calculation of the MACT floor would 

produce emission limits that would result in estimated national mercury emissions 

of34 tons per year (i.e., EPA's current estimate of the co-benefit ofS02 and NOx 

proposed regulations). 

Recommendations 

We recommend that the Assistant Administrator for Air and Radiation: 

2-1 Conduct an unbiased analysis of the mercury emissions data to establish a 

MACT floor in accordance with the requirements ofCAA section 112(d). 

2-2 Re-negotiate with the court petitioner for an extension of the final 

rulemaking deadline sufficient to solicit and accept public comments on 

the tmbiased analysis of mercury emissions data in an open, public, and 

transparent manner. 

Agency Comments and OIG Evaluation 

The Agency commented that the draft report incorrectly characterized the 

calculation of the MACT standard, and that the Agency had calculated the MACT 

16 The Clean Air Task Force considered the effect of implementing the proposed CAIR rule on the mercury 

MACT. EPA did not consider the impact of implementing CAIR in its MACT modeling efforts. More information 

on this issue is found in Chapter 4 of this report. 

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floor in accordance with the requirements of CAA section 112( d). The Agency 

also maintained that its extensive work, including development of the proposed 

Clear Skies legislation, showed that, in the absence of immediately available 

mercury control technology, the mercury reductions as co~benefits of S02 and 

NOx controls represent the lowest level of mercury emissions that the Agency 

reasonably expects could be achieved. We believe our report accurately 

characterized the MACT development process. Our observations were based on 

review of supporting documentation related to MACT development, and 

interviews with Agency staff and stakeholders involved in the process, including 

State and local, environmental, and industry groups. Although the MACT floor 

was ostensibly based on data from the top perfonning 12 percent of units, this data 

was analyzed with a final target already in mind, i.e., 34 tons. While the Agency 

has conducted analysis to determine the co-benefit of S02 and NOx controls, we 

do not believe this meets the requirements ofCAA section 112(d) in developing 

the MACT standard. The Agency's complete response to the draft report and our 

evaluation of its response are in Appendix E. 

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EPA's mercury cap-and-trade proposal a nationwide emissions trading program 

for an air toxic- can be strengthened to better ensure that human health is 

protected and that anticipated emission reductions are achieved, should this 

approach to reducing mercmy emissions be adopted. The cap-and-trade proposal 

could be strengthened by: 

Adequately addressing the potential for hot spots. 

Establishing an interim cap that would provide greater incentive for utilities to 

install mercury-specific control technology by 20 I 0. 

Setting a reasonable safety valve provision. 

Clarifying conditions pertaining to exemptions for small emitting facilities. 

These changes could help ensure that the proposed mercury cap-and-trade 

program obtains the desired emissions reductions in a timely manner. 

EPA's Proposed Cap-and-Trade Approach 

A cap-and-trade program could provide several benefits in terms of controlling 

emissions. Trading programs generally provide regulated units with more 

flexibility to meet overall emissions reductions than do conventional commandand-control approaches because a unit may apply whichever control method it 

finds to be most appropriate and cost-effective to meet emission limits. This 

flexibility serves to minimize overall control costs in the market. Furthermore, 

cap-and-trade programs can provide greater environmental certainty by 

establishing fixed national emissions caps that cannot be exceeded. However, a 

cap-and-trade program's environmental benefits will depend on the adequacy of 

the cap. 

Under EPA's proposed mercury emissions trading program, units that cannot costeffectively reduce emissions through controls may buy allowances from units that 

were able to reduce emissions beyond their established allowance limits and are 

willing to sell their extra allowances. Each unit is required to possess one 

emissions allowance per each ounce of mercury it emits. Units would be allowed 

to buy and sell credits among one another in a national emissions market. EPA's 

proposed cap-and-trade alternative proposes that the interim mercury emissions 

cap for 2010 be based on the amount of mercury reductions achieved solely as a 

co-benefit through implementation of S02 and NOx controls under the proposed 

CAIR. As noted in Chapter 2, EPA's latest estimate of the mercury benefit from 

implementing CAIR is 34 tons per year. The cap-and-trade proposal sets a final 

cap of 15 tons per year in 2018. 

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Proposed Cap-and Trade Program Needs to Further Address 

Certain Issues 

The proposed cap-and-trade rule for mercury meets the three basic guiding 

principles of trading programs as defined by EPA: a cap on emissions, 

accountability, and simplicity of design and implementation. However, we 

identified four issues with EPA's mercury cap-and-trade proposal that need to be 

further addressed. Details follow on each issue. 

Interim Cap Could Be Tightened to Force Earlier Development of 

Mercury-Specific Control Technology 

Although EPA has not yet set a specific interim cap for 2010, the preamble to the 

proposed rule states that the interim cap will be based solely on the mercury 

emissions reductions achieved as co-benefits of regulating SO, and NOx under 

CAIR, estimated by EPA to be 34 tons. Thus, it would not be necessary for units 

to install mercury-specific controls in order to meet the 20 I 0 interim cap, and this 

would limit the effectiveness of the regulation to force new technological 

advances in mercury control. If the interim cap under this proposal is set at 34 

tons, utilities could delay consideration of installing new mercury-specific 

technology until meeting the more stringent cap in 2018 is imminent. However, 

according to EPA officials, if the banking provision of the cap-and-trade program 

operates as intended, some facilities would have the incentive to implement 

mercury-specific controls before 2018, which would reduce emissions beyond the 

interim cap level before the final cap becomes effective. EPA officials also 

pointed out that experience under other cap-and-trade programs has shown that 

the largest emitters are typically the first to reduce emissions and will generally 

achieve the greatest level of reductions. According to the preamble, the reason for 

basing the interim cap solely on the co-benefits from CAIR is that EPA does not 

believe mercury control technology that has been demonstrated for all coal types 

is commercially available. 

Further, the proposed rule does not address what would happen under the cap-andtrade approach ifCAIR is not implemented. Given that the 2010 cap is based 

solely on the co-benefits from CAIR, it is unclear what would occur under the 

proposed rule if CAIR is not implemented. 

An EPA official stated that although some EPA staff indicated they would like to 

see analyses on different cap levels for comparison purposes, no such formal 

analyses were conducted. EPA conducted one IPM run based on an interim cap of 

34 tons and a final cap of 15 tons (in conjunction with CAIR), but no runs were 

conducted using alternative caps for comparison. Clear Skies analyses were made 

available in the proposed mercury rule docket, and according to an EPA official 

the mercury cap-and-trade IPM run is comparable to the Clear Skies !PM runs. 

According to this EPA official, one such run of Clear Skies had a different interim 

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cap (26 tons) and this run, while not exactly matching the modeling conducted for 

the proposed mercury cap-and-trade program, provides an idea about the costs of 

an alternative mercury cap. 

Potential for Hot Spots Not Fully Analyzed 

EPA did not fully analyze the potential for hot spots (i.e., areas of elevated 

pollutant concentrations) to occur under its proposed cap-and-trade option. The 

potential for hot spot formation under the proposed cap-and-trade rule has 

generated a great deal of concern and debate among various stakeholders. 

Modeling and projecting the likelihood of hot spots under the proposed rule is 

made difficult by the relatively high degree of uncertainty involved with mercury 

transport and deposition patterns (i.e., when the airborne mercury is deposited 

onto the ground or into water bodies), particularly local or near-field deposition. 

Further complicating efforts to use computer models to determine where mercury 

deposition will occur is the fact that three different chemical forms of mercury are 

emitted by utility units and each has varying deposition patterns. For example, 

oxidized and particulate mercury are more likely to deposit locally or regionally, 

while elemental mercury travels and is more global in nature. Although air 

emission-related hot spots are generally thought of in tenus of high ambient air 

concentrations near a source, this is not the only consideration with mercury. The 

main health risk associated with mercury is not its ambient concentrations, but 

rather its deposition into water bodies and resulting bioaccumulation in fish. 

However, the connection between air emissions and levels of mercury ultimately 

found in fish tissue is not yet fully understood. 

EPA's Clean Air Markets Division conducted a Proximity Analysis to determine 

"where, in relation to water bodies, emissions would occur" under the mercury 

emissions trading provision of the Clean Air Interstate Rule. However, as noted 

in the analysis, the issue of hot spots was not fully analyzed: 

This examination of projected mercury emissions has sign[(icant 

limitations and does not constitute an analysis of "hotspots." Such an 

analysis of hotspots would. in part, necessitate detailed assessments of the 

atmosphericfate, transport, and deposition of mercury from power 

generating sources, and assessments of the potential population exposure 

to mercury contaminated fish in water bodies due to generating and other 

sources. 

Although EPA did not conduct the detailed assessment of hot spots described 

above, EPA stated in the preamble to the proposed rule that it does not expect hot 

spots to occur for several reasons, as follows: 

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Modeling suggests that the largest emitters, which are more likely to produce 

local deposition, will be the first to implement control technology under a capand-trade approach and will reduce emissions by the largest amount. 

CAIR would result in implementation of control technologies for S02 and 

NOx that also provide the co-benefit of reducing emissions of the types of 

mercury (oxidized and particulate) that are likely to deposit locally. 

The Acid Rain program has not resulted in the fom1ation of hot spots. 

States have "the ability to address local health-based concerns separate from 

the mercury cap-and-trade program requirements," and under the proposed 

State-administered program would "retain the power ... to adopt stricter 

regulations to address local hot spots or other problems." 

The proposed final cap would be a 70-percent reduction in mercury emissions 

from current uncontrolled levels (from 48 to 15 tons). 

However, potential problems arise with EPA's reasoning. For example, the Acid 

Rain program controls for S02 emissions, which are primarily deposited 

regionally and globally, not locally, while mercury can deposit locally as well as 

regionally and globally. Trading programs are generally thought to be most 

effective for pollutants that do not deposit locally. Further, the Acid Rain 

program co-exists with the National Ambient Air Quality Standards program, 

which has established a minimum level of air quality for S02, while no such 

minimum standards exist as a back-stop in the mercury cap-and-trade proposal. In 

addition, the Acid Rain program contains a provision stipulating that, in the case 

of delayed implementation due to litigation, a more conventional command-andcontrol approach would take effect, but the proposed cap-and-trade rule for 

mercury lacks a similar provision. 

While the preamble to the proposed rule notes that individual States have the 

authority under section Ill to adopt stricter regulations than those set by EPA, it 

does not address whether States would have this same authority under a section 

112 cap-and-trade program. Further, approximately one-third of States have laws 

limiting "the ability of their regulatory agencies to adopt regulations that are more 

stringent than any federal environmental regulation." Thus, these States may not 

be able to adequately address hot spots, should they arise. 

EPA has recognized that additional infonnation is needed to better understand and 

address potential hot spots. For example, in the preamble to the proposed rule, 

EPA states its intent to reassess the hot spot issue by taking a" ... hard look at the 

Hg emissions inventory after full implementation of the first phase cap ... ," and 

also requested comments on how it might address hot spots in a cap-and-trade 

program. In addition, EPA suggested the use of trading ratios between regions as 

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a way to address potential regional deposition differences. The Agency also 

requested site-specific data on areas where corrunenters believe hot spots would 

continue to exist if a cap-and-trade program were implemented. 

Due to time constraints, the OIG did not fully evaluate potential environmental 

justice implications resulting from a cap-and-trade program, nor did we fully 

assess the extent of the Agency's analysis of these issues. 

Safety Valve Provision May Not Encourage Reductions 

The proposed safety valve price may be set too low to achieve the intended effect 

of reducing mercury emissions through the installation of control technology and 

the open-market trading of emission allowances. The safety valve provision in the 

proposed cap-and-trade mercury rule provides a price cap on the cost of emissions 

reductions, and was included in the proposed rule due to uncertainties associated 

with future costs and the availability of mercury control technologies. Under the 

safety valve provisions of the proposed rule, if the price of allowances reaches a 

certain level, units will be permitted to borrow allowances from the future for a 

fixed price. To help ensure that the overall cap on emissions is met over the longterm, units can borrow only from their own bank of future allowances. The 

provision is intended to "minimize unanticipated market volatility" and ensure 

that "the cost of control does not exceed a certain level." Thus, in effect, units 

may emit more in the current period, but would be forced to emit less in the future 

because they are using future allowances. However, we identified two concerns 

with the proposed safety valve provisions. 

Safety Valve Price. For a safety valve provision to be used appropriately (that is, 

only when market volatility makes it necessary), the price should be set so that it 

is higher than the market price of allowances or the actual cost of abatement 

(emission reduction). If this price is too low, it may be cheaper for the unit 

operator to purchase future emissions allowance at the safety valve price rather 

than installing emission controls. Under the proposed rule, the safety valve price 

is set at $35,000 per pound, or $2,187.50 per ounce, adjusted annually for 

inflation. This figure was decided upon during development of the Clear Skies 

Initiative, but new analyses have estimated that the actual cost of abatement will 

be substantially higher than $35,000 per pound. 

Although EPA stated in one of the rule's supporting documents that, "based on 

current technological capabilities, the cost of mercury removal is expected to 

reach the safety valve price ($35,000/lb) by 20 I 0," it further stated that 

"technological improvements could decrease the cost of mercury control over time 

and cause prices to remain below safety valve levels." Staff within EPA indicated 

that the current safety valve price of$35,000 was too low based on new analyses. 

For example, 2003 and 2004 Department of Energy estimates show the "baseline 

costs" of mercury removal to be $50,000- $75,000 per pound, with cost 

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reductions expected over time. However, senior EPA officials told us that they 

did not believe the safety valve price would be reached because they expect the 

cost of activated carbon injection, a mercury-specific control technology, to 

decrease over time. According to these officials, the IPM does not account for 

this variable and may be misleading since it shows the cost of activated carbon 

injection remaining constant over time. 

Safety Valve Borrowing. The proposed rule stated that units may purchase safety 

valve allowances from "following years," and the supplemental notice stated they 

may be purchased from allowances available for allocation in the next control 

period. The supplemental notice also provided an example of how a State could 

incorporate the safety valve provision into its cap-and-trade program. However, 

the proposed safety valve provision does not place a limit on the number of 

allowances a unit can borrow under this provision. As the Clean Air Task Force 

writes in its comments, a unit could, theoretically, continue borrowing indefinitely 

from future years by buying safety valve allowances in lieu of installing controls 

or buying allowances on the open market. Such an approach would make 

economic sense as long as the proposed safety valve price was set lower than the 

baseline cost of controls. In the proposed rule, EPA acknowledges that its 

"proposed approach may create implementation problems associated with the need 

to 'reconcile' at some point in time the allowances borrowed from future 

compliance periods," and requests comment on the issue. 

Small Emitters Exemption Needs To Be Clarified 

EPA has proposed that utility units emitting less than 25 pounds ofmercmy per 

year be exempt from the cap-and-trade program, but has not completely addressed 

how their exemption and the national emission cap will be impacted if their 

emissions increase. EPA included this exemption because of concerns that new 

mercury-specific control technologies expected to be developed may not 

practicably apply to these units. Based on EPA data developed for units 

operational in 1999, 396 of the I, 120 units operational in 1999 were estimated to 

have emitted less than 25 pounds of mercury per year each. These 396 units made 

up 35.4 percent of the total operating units, but contributed only 3,742 of the 

95,975 pounds of estimated mercury emissions, or 3.9 percent in 1999. 

According to the proposed rule's preamble, EPA states there is reason to believe 

that the 15-tons Phase II cap can be achieved in a cost effective manner, even if 

the lowest emitting 396 units are excluded from coverage under this cap. EPA is 

soliciting comment on this proposal. 

One commenter noted that both capacity utilization and emission rate increases 

could occur in small emitting sources after they have been exempted from capand-trade requirements. EPA does not address this issue in the proposed rule. 

Another commenter stated that EPA had done no analysis of the small emitter 

exemption with respect to either costs or impacts. According to this commenter, a 

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vast majority ofthe units emitting less than 25 pounds of mercury are part of a 

multi-boiler facility, and it is entirely likely that at some facilities all of the boilers 

are tied into common duct work for pollution control. Consequently, these units 

should be considered as one unit emitting over 25 pounds and not eligible for the 

exemption. 

While we did not fully assess the impact of this, we believe the commenters have 

raised valid concerns. Further, we noted that the relative significance of these 

small emitters increases as the cap-and-trade program progresses. For example, in 

2018, these emitters, based on their 1999 emissions, would represent 12.5 percent 

of the total15 tons in emissions allowed under the final cap. If EPA moves 

forward with its cap-and-trade proposal, the Agency can better ensure that 

anticipated emission reductions are achieved if it clearly addresses the 

circumstances under which small emitters would have to participate in the capand-trade program. 

Proposed Emissions Trading Rule Should Also Address Tribal 

Concerns 

Although Executive Order 13175 requires EPA to develop an "accountable 

process to ensure meaningful and timely input by tribal officials in the 

development of regulatory policies that have tribal implications,'m tribal concerns 

were not addressed during development of the proposed cap-and-trade rule. In the 

preamble, EPA states that the proposed rule may have tribal implications because 

two coal-fired utility units are located in Indian Country. Representatives from 

the National Tribal Environmental Council (NTEC) informed us that neither they 

nor their approximately 180 member tribes had any involvement in the 

development of the proposed mercury rule. This was confmned by an EPA 

official at a March 2004 public meeting on the proposed mercury rule. 

Among NTEC's greatest concerns over the proposed mercury rule are: 

the absence of tribal involvement and/or consultation in the development of 

the proposal; 

a failure to adequately monitor mercury deposition on tribal lands, which 

means that the impact of mercury is unknown; and 

lack of consideration for American Indians and Alaska Natives' dependence 

upon fish and the terrestrial animals that feed on those local fish. 

The average tribal member and child eats much more fish than the typical 

consumer and the representatives explained that tribes (especially children and the 

expanding youth population) are faced with increased adverse health effects 

17 Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). 

24 
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caused by such exposure. 

NTEC does not support the cap-and-trade program and noted that, if the program 

is implemented, there is no mechanism currently in place for the tribes to enter 

into cap-and-trade allowance sales. In fact, allowances are only available to the 

States. NTEC cited the U.S. Government's trust responsibility, which includes 

looking after the health and survival of tribes. This responsibility is met in part by 

conducting tribal consultation on a government-to-government basis. 

EPA officials noted that other organizations, including States, were not consulted 

during the development of the cap-and-trade proposal. Although States were not 

consulted, we noted that States were allotted mercury allowances while the Tribes 

were not. 

Conclusions 

The cap-and-trade proposal can be strengthened to better ensure that the 

anticipated emission reductions are achieved, should this approach be adopted by 

EPA. First, the interim cap suggested under the current proposal is set at a level 

that could be met without installing mercury-specific control technology, thus 

potentially delaying installation of mercury-specific controls until 2018. Also, the 

cap-and-trade option has not adequately addressed the potential for hot spots. In 

addition, EPA needs to ensure that it establishes a safety valve provision that will 

have the intended effect of encouraging unit operators to install controls or buy 

emission credits. Further, EPA needs to ensure adequate tribal involvement for 

the proposed mercury rule to ensure that tribes are not negatively impacted by a 

cap-and-trade rule. 

Recommendations 

We recommend that the Assistant Administrator for Air and Radiation: 

3-1 Re-assess the basis for the interim and final caps. This analysis should 

consider the results of the re-assessed MACT floor (see Recommendation 

2-l). 

3-2 Further assess the risk of hot spots and, if CAA section 112 residual risk 

requirements are not implemented, then section Ill cap-and-trade 

regulations should specifically identify how EPA will meet its intention to 

reassess the hot spots issue. 

3-3 Strengthen the safety valve provision so that the safety valve price is set at 

a level whereby it is only used for its intended purpose of minimizing 

unanticipated market volatility. Alternatively, EPA may stipulate other 

25 
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controls over borrowing from future allowances, such as imposing a 

greater than I: I allowance trading ratio; and allowances borrowed from 

the future will be reconciled to ensure that facilities cannot borrow 

indefinitely into the future. 

3-4 Reassess the necessity of a small emitter exemption, and if a decision is 

made to exempt, explain in sufficient detail the reasoning for such a 

provision and establish how small emitters will be handled within the capand-trade program should they exceed emissions of 25 pounds a year. 

3-5 Address tribal issues by: developing a mercury emissions consultation 

strategy with tribes, with the assistance of tribal representatives, that will 

ensure the Agency fulfills its trust responsibility and conducts proper 

government-to-government consultation with tribes; and establishing a 

mechanism for coal-fired utilities located on tribal lands to participate in 

the cap-and-trade approach. 

Agency Comments and OIG Evaluation 

The Agency's comments expressed a concern that the report does not 

"comprehensively and accurately describe" how the proposed cap-and-trade 

approach would work. The Agency also expressed concern that we did not 

highlight the knowledge EPA has gained from modeling and past experience with 

cap-and-trade progran1s. We believe our draft report portrayed an accurate 

representation of how the proposed mercury cap-and-trade program would work. 

One of the objectives of our review was to evaluate whether the proposed cap and 

trade rule was sufficiently protective of public health. As a result, we highlighted 

certain concerns with the rule as proposed. We made revisions, where 

appropriate, based on technical comments made by Agency staff and officials. 

However, there are several important differences between the Acid Rain program, 

to which the Agency often refers when discussing past cap-and-trade experience, 

and the proposed mercury cap-and-trade program. The Agency's complete 

response to the draft report and our evaluation of its response are in Appendix E. 

26 
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Although EPA rulemaking procedures are not always applied consistently, many 

Agency staff told us that they would have expected greater adherence to the 

guidance for mercury rule development due to the significance of this particular 

regulatory action, but this did not happen. When the Clear Skies legislation 

stalled, EPA decided to address the Clear Skies program in a regulatory manner 

instead. This led to EPA including a mercury cap-and-trade option, similar to 

Clear Skies, in its proposed mercury rule. As focus on the cap-and-trade approach 

increased, EPA began to de-emphasize the mercury MACT development process. 

This included: 

Cancelling the next scheduled Federal Advisory Committee Act (FACA) 

meeting and ending communication with F ACA members. 

Abridging the normal intra-agency review process, particularly at the staff 

level. 

Failing to fully address the cost-benefit ofMACT alternatives and not 

analyzing the potential impact of implementing CAIR on the proposed MACT 

option. 

Not fully analyzing the impact of the proposed mercury cap-and-trade program 

on children's health. 

Description of Rulemaking Process 

EPA 's Action Development Process: Guidance for EPA staff on Developing 

Quality Actions outlines steps EPA staff and management are to follow when 

developing Agency actions, such as rules, policy statements, and statutorily 

mandated reports to Congress. The guidance suggests that EPA staff follow a 

prescribed set of steps beginning with tiering the action based on several of its 

characteristics. Once tiered, a standard process exists for developing the proposed 

action. As a Tier One action, the proposed mercury utility rule was considered a 

top action that would" ... demand the ongoing involvement of the 

Administrator's office and extensive cross-Agency involvement on the part of the 

AAs/RAs (Assistant Administrators and Regional Administrators)." 

The Action Development Process guidance contains five key elements, which are 

summarized below. These include steps for: 

planning sound scientific and economic analysis; 

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developing and selecting regulatory options based on relevant scientific, 

economic, and policy analyses; 

involving affected Headquarters and Regional managers early and continuing 

involvement until the final action is completed; 

ensuring active and appropriate cross-Agency participation; and 

encouraging appropriate and meaningful consultation with stakeholders 

through substantive consultative procedures. 

Appendix D describes the rule development process in detail. 

Some FACA Members Considered Job Unfinished 

Within EPA, the creation of an advisory committee is not required for MACT rule 

developments, but such groups have been formed to advise the Agency in past 

MACT rulemakings and can provide a means of substantive consultation with 

stakeholders. An EPA official noted that for contentious rulemakings where a 

great deal of stakeholder involvement and public comment is anticipated, such as 

the mercury rule, it is not uncommon for an advisory committee to be formed. 

F ACA allows for the creation of committees, boards, commissions, councils, and 

similar groups to furnish expert advice, ideas, and diverse opinions to officers and 

agencies in the executive branch of the Federal Government. The Act notes that 

the function of committees is advisory only, and decisions on how the advice will 

be used is determined by the official, agency, or officer involved. 

The FACA working group for this rulemaking, known as the Utility MACT 

working group, was formed within the Permits/New Source Review Air Toxics 

Subcommittee of the larger Clean Air Act Advisory Committee. Working group 

members consisted of representatives from State and local agencies; 

environmental organizations; industry; control equipment vendors; and coal 

interests, producers, and unions. Both co-chairs of the group indicated that they 

believed the working group had balanced stakeholder representation." The 

working group was formed for an initial period of I year and met approximately 

once per month starting August 200 I. 

The working group was charged with providing input for the development of a 

MACT standard for utilities. In a presentation given to the group by the EPA cochair, the group was instructed that they were not to reconsider the Agency's prior 

finding that regulation of coal-fired electric steam generating units under section 

112 of the CAA was necessary and appropriate, nor were they to consider a capand-trade option. Although a cap-and-trade option was introduced in Congress in 

July 2002 in the Clear Skies legislation, this option was not considered by the 

working group. 

18 Although the working group did not include tribal representation, EPA solicited their participation. 

28 
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In October 2002, the working group issued its final report, Recommendations for 

the Utility Air Taxies MACT: Final Working Group Report, in which it identified 

issues that "EPA must consider and resolve in its drafting of the utility MACT." 

Some of the issues identified included: 

sub-categories; 

floor levels; 

beyond-the-floor levels of mercury; 

compliance method (monitoring); and 

compliance time. 

The working group decided early that consensus among its various stakeholder 

groups was unlikely, and did not attempt to reach agreement on specific 

recommendations it could make to the Agency. Instead, the report presented the 

opinions of all the stakeholders on the issues. 

Though the working group issued the final report in October 2002, it held another 

meeting on March 4, 2003, just after Clear Skies legislation was re-proposed in 

February. Certain members of the working group had requested that EPA conduct 

additional analyses using the IPM to further explore the cost-benefit of different 

MACT proposals as presented by the working group members. Members of the 

working group did not have direct access to the IPM, as EPA contracts for its use 

through a third party, and thus requested that EPA have the additional analyses 

run and then provide the group with the results. According to several members of 

the working group we contacted, it was expected that the working group would 

receive the results of the additionally requested IPM runs at the March 4 meeting, 

but were instead told the nms were not yet complete. Another meeting was 

scheduled for April 15, 2003, to provide the results of the IPM runs, but members 

were notified by EPA of its cancellation via e-mail on April I. 

In July 2003, Administrator Whitman responded to Congressman Waxman's 

request for the status of IPM runs for the working group. The Administrator 

stated that it was the Agency's intention to convene an additional FACA meeting 

when the IPM analyses were complete. However, in March 2004, the Assistant 

Administrator for Air and Radiation said the Agency would not provide the 

additional MACT IPM analyses and would instead focus resources on developing 

a cap-and-trade alternative, the administration's preferred regulatory approach. 

The working group has not met since its last meeting in March 2003 and has not 

been officially contacted by the Agency since its planned April 15,2003, meeting 

was cancelled. A fonnal notice of termination has not been issued to the working 

group and, according to some members, they were not given an explanation as to 

why the working group ended. EPA has stated on its web site that it began 

proceeding with a cap-and-trade regulatory approach in the absence of 

Congressional action on Clear Skies legislation. The FACA working group's 

29 
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27172.712

deliberations were stopped after Clear Skies was re-proposed and before EPA 

began developing its proposed cap-and-trade regulation. While some working 

group members indicated satisfaction with the work completed by the group, 

others considered the job unfinished due to the lack of opportunity to consider the 

additionally requested runs. 

According to senior EPA officials, the working group's original charter was for 

only one year. One of the officials acknowledged that EPA had initially intended 

to conduct the runs requested by the working group but later decided that it would 

not be beneficial. These officials further indicated that since the working group 

had not reached consensus, the Agency did not believe the working group should 

have been extended. 

Intra-Agency Review Limited 

According to staff involved, the intra-agency work group review process followed 

in this rulemaking varied significantly from past Agency practice and applicable 

guidance for Tier One rules in that the group only met two times and was not 

given an opportunity to provide meaningful feedback on the proposed rule. 

According to the Agency's regulatory development guidance, a work group is to 

meet frequently enough to ensure that all significant issues and options are 

discussed and agreed upon. Then, the significant issues and several options to 

resolve each issue are to be provided to senior management. Senior management 

then selects those options they believe will best achieve the goals of the action for 

a Final Agency Review. 

The work group's first meeting was held on February 27, 2003, and the second 

and final meeting took place on August 7, 2004. In preparation for the first 

meeting, the work group chair e-mailed to the work group members a copy of the 

Utility MACT FACA working group's final report, along with a draft analytical 

blueprint for the rulemaking. According to EPA's Action Development Plan, an 

analytical blueprint is "a document that spells out a work group's plans for data 

collection and analyses that will support development of a specific action," and is 

intended to be developed as "a collaborative effort." The draft blueprint stated, 

"the intent of the rule is to require that oil-and-coal-fired units achieve a MACTlevel of control," and it listed the "minimum analytical needs" for the rulemaking: 

A regulatory impact analysis, assessing the economic impact on industry of 

levels beyond the MACT floor. 

Assessment of multi-pathway concems. 

A regulatory flexibility analysis addressing small business concerns. 

Assessment of environmental justice concerns. 

Children's health concerns. 

Unfunded mandate assessment, evaluating the impact of the rulemaking on 

State/local/tribal governments, some of which own or operate coal-fired units. 

30 
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27172.713

ICR issues. 

Although the above issues were identified for study in the draft analytical 

blueprint, some were never fully addressed, such as the children's health study 

and an assessment of environmental justice concerns. The draft blueprint also 

stated that: 

" ... the EPA believes that emissions trading is prohibited under Section 112 

of the CAA. However, industry, and to a more limited extent, some other 

stakeholders would like to explore emissions trading as an option (perhaps in 

beyond-the-floor analyses) for this rulemaking. " 

Members of the work group, including the Office of Research and Development 

and the Office of Policy, Economics, and Innovation, submitted comments to the 

draft analytical blueprint via e-mail to the work group chair. But work group 

participants we interviewed stated that they received no feedback or modified 

drafts of any work products based on their comments and input. 

In preparation for the second intra-agency workgroup meeting, members were 

asked to review and comment on four sections (approximately 42 pages) of an 

early version of the draft (July 3, 2003) preamble. However, intra-agency 

workgroup members received no modified work products that incorporated their 

feedback. Additionally, no Final Agency Review meeting was held for the 

proposed mercury rule whereby core intra-agency review participants had the 

opportunity to concur or nonconcur with the proposed rule before it was sent to 

OMB for review and final action. 

Several EPA staff who were involved in the abbreviated intra-agency work group 

review process told the OIG that it was made clear to them by their managers, and 

in the case of one work group representative, by the work group chair, that 

decisions about this rule were being made at a "higher level." For example, in an 

e-mail discussing intra-agency comments, a member of the work group was told: 

The decision was made at a much higher level than mine to 

"bypass" the normal EPA Work Group procedure prior to the 

proposal and we have been told that all the Office directors 

were contacted about both the process change and rulemaking. 

Similarly, these officials told us that it became clear to members that their 

feedback would not likely be considered. One Agency source said that, in 

general, there was not a meaningful opportunity for EPA offices to comment on 

this rule. Some Agency officials said they considered the intra-agency review 

process to have been conducted, but at a higher staff level and with less input than 

usual from lower staff levels. However, at least one office usually involved in the 

intra-agency review process the Office of Enforcement and Compliance 

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Assurance was neither given the opporllmity to review nor submit comments 

regarding the proposed rule before it was sent to OMB, according to former and 

current Office of Enforcement and Compliance Assurance officials contacted. 

According to senior EPA officials it is not unusual during the development of 

high-profile rules, particularly those under a tight deadline, for EPA to not strictly 

follow the Agency's prescribed rulemaking process. 

Requirements for Cost-Benefit Analyses Not Fully Implemented 

Although EPA conducted certain required analyses, other analyses were not 

completed. For rulemakings with an annual economic impact of $100 million or 

more, Executive Order 1286619 requires that Federal agencies, in deciding whether 

or how to regulate, assess all costs and benefits of available regulatory alternatives 

and provide the reasoning for selecting the proposed regulatory action over such 

alternatives. This Executive Order also directs that Federal agencies base their 

decisions on the best reasonably obtainable scientific, technical, and economic 

information concerning the need for, and consequences of, the intended 

regulation. 

EPA staff told OIG that senior management instructed them not to undertake 

certain scientific and technical analyses that they thought necessary. For example, 

staff were instructed during meetings not to conduct IPM runs (which could have 

been helpful in considering alternatives) until they were told the national mercury 

emissions per year desired for the MACT. As discussed in Chapter 2, EPA 

conducted analyses of various MACT floor levels, but presented only a 34-tonsper-year option to the public. In addition, the Agency did not fully analyze a 

beyond-the-floor MACT alternative. 

EPA's cost-benefit analysis of the MACT proposal did not take into account 

mercury emissions reductions that would be gained as co-benefits resulting from 

NOx and S02 controls installed under the proposed CAIR. However, the 

Agency's cost-benefit analysis of the cap-and-trade option did consider CAIR 

co-benefits. This prevents a balanced comparison of the two options. EPA staff 

told us that a MACT-plus-CAIR alternative was not analyzed because, when the 

MACT floor was completed, CAIR had not yet been proposed. However, EPA 

issued a December 2004 Notice of Data Availability for the proposed rule, which 

included an analysis submitted by the Clean Air Task Force that estimates the 

impact (in terms of emission reductions) of CAIR in conjunction with the 

proposed MACT standard. The notice did not include a similar analysis by EPA. 

The Agency did not monetize the health benefits of mercury reductions, though 

19 Regulatory Planning and Review, 58 FR 51735, October 4, 1993. 

32 
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27172.715

Office of Air and Radiation staff have said the final rule will include quantitative, 

non-monetized endpoints as well as a qualitative discussion. EPA staff told us 

that they have ongoing efforts to develop a benefits analysis, but that it is slow 

moving and has not been completed. Since March 2004, when the Administrator 

stated the Agency would take a closer look at the issue, there has been a process to 

try and do a full benefits analysis, but the process is moving slowly. While a 

benefits analysis should be based on scientific literature, staff told us that there 

had been pressure to base the analysis on public comment through the Notice of 

Data Availability. The notice presents a methodology for determining the benefit 

of mercury reductions and requests comment on this methodology. 

Required Children's Health Analysis Not Comprehensive 

EPA did not adequately evaluate the environmental health effects of the proposed 

rule on children. Executive Order 1304520 requires such an evaluation because 

"[a] growing body of scientific knowledge demonstrates that children may suffer 

disproportionately from environmental health risks and safety risks." In prior 

MACT rulemakings EPA had determined that Executive Order 13045 and, 

therefore, a children's health evaluation, is not applicable because MACTs are 

technology standards and apply consistently to covered sources. However, since 

the proposed rule includes a cap-and-trade option, which is a performance 

standard that could result in an uneven distribution of emissions, it is covered 

under Executive Order 13045 and, therefore, an analysis of the rule's impact on 

children's health is required. 

Although the proposed rule states that EPA evaluated health and safety effects 

pertaining to children, our review of the proposal and docket did not show that 

EPA performed such analyses in accordance with Executive Order 13045. We 

requested such analyses from EPA, but were not provided with any specific 

studies of the rule's impact on children's health. Interviews with officials from 

EPA's Office of Children's Health Protection indicated they were not involved 

during the rule development. However, Office of Children's Health Protection 

staff said their lack of involvement in such functions is not unusual due to limited 

staffing." Members of the Children's Health Protection Advisory Committee 

(CHPAC) told us that the proposed rule does not adequately take into account 

children's vulnerabilities. The CHP AC outlined their concerns in a January 26, 

2004 letter to the Administrator, in which they made several recommendations, 

including that the Agency "[e]valuate the possibility that hot spots could result" 

20 Protection of Children From Environmental Health Risks and Safety Risks, 62 FR 19885, April 23, 1997. 

21 A May 2004 OIG report found that there was no overall, coordinated strategy integrating children's 

environmental health efforts into the Agency as a whole (The Effectiveness of the Office of Children's Health 

Protection Cannot Yet Be Determined Quantitatively; OIG Report No. 2004-P-00016; May 17, 2004). 

33 
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27172.716

from the cap-and-trade program as proposed.22 In a subsequent June 8, 2004 letter 

to the Administrator, CHPAC additionally recommended that EPA "(e]valuate the 

relative health benefits of reducing mercury exposure for children and women of 

child-bearing age under the MACT and cap-and-trade regulatory options." 

EPA senior officials noted that prior studies on the health impact of mercury 

addressed the impact of methylmercury exposure on children and, therefore, the 

rule itself addresses children's health. We recognize that current reference dose 

levels for mercury exposure are based on the impact to children's health. 

However, we were not provided any analyses assessing the extent to which the 

proposed rule may result in uneven distribution of mercury deposition that could 

increase some children's exposure to mercury. Office of Research and 

Development officials noted that regardless of the extent of any additional 

analysis, they do not know what the impact of reducing sources emissions by a 

certain percentage would have on deposition or in what timeframe. However, 

they noted that reductions in emissions will reduce atmospheric mercury, which in 

tum will result in less deposition, lower mercury levels in fish, and ultimately 

reductions in human exposure to mercury. EPA officials stated that this type of 

extensive analysis had not been done for the proposed rule, but they hoped to have 

a more detailed assessment for the final rule. They further explained that the 

Notice of Data Availability issued in December 2004 proposed a process for 

quantifying the proposed rule's impact on mercury deposition and the resulting 

bioaccumulation in the environment. 

Scope Limitation: Inter-Agency Review 

Due to time constraints23 and the fact that OMB controls this process and not 

EPA, the OIG did not evaluate the inter-agency review process and EPA's 

response to the edits resulting from that process. The inter-agency review process 

occurs under the direction of OMB after a proposed rule is submitted to the Office 

oflnformation and Regulatory Affairs in OMB for review, as stipulated in 

Executive Order 12866. The process is typically infonnal and, according to one 

EPA official, details on the meetings between OMB and other agencies, as well as 

comments submitted to OMB during the review, often are not included in the 

formal docket. 

It is difficult to determine every agency involved in the editing process, which 

agency made specific edits to the proposal, or the timing of these edits based on 

inter-agency review documents contained in the docket. We identifted comments 

from at least four agencies or offices other than EPA and OMB: the Department 

22 Chapter 3 of this report recommends that EPA further assess the risk of hot spots. 

23 Our field work in some areas was limited in order to provide the results of our review to EPA 

management in time for them to consider our recommendations in developing the final rule. 

34 
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of Energy; the Department of the Interior; the Small Business Administration; and 

the Council on Enviromnental Quality. 

Conclusions 

The rulemaking process did not meet the expectations of some EPA staff and 

FACA work group members, and did not fully address certain Executive Order 

requirements to conduct cost-benefit and children's health analyses. These 

deviations from prior practice and Executive Order requirements appeared to have 

occurred, in part, because of the Agency's decision to include a proposed cap-andtrade option in the proposed rule, as well as a need to meet the deadlines for the 

proposed MACT rule reached in prior court settlements. 

Recommendations 

We recommend that the Assistant Administrator for Air and Radiation: 

4-l Ensure that the Office adheres to the Action Development Process during 

EPA's future rulemaking actions to include obtaining input from all 

relevant Agency Offices. 

4-2 Conduct more in-depth cost-benefit analyses of the proposed mercury 

options to determine the preferred approach. 

4-3 Conduct a more in-depth analysis of the impact of the proposed options on 

children's health. 

Agency Comments and OIG Evaluation 

The Agency stated that the draft report failed to recognize the nature of the 

regulatory development process and incorrectly stated that EPA did not 

adequately evaluate the proposed rule's impact on children's health. Further, the 

Agency stated that the draft report improperly characterized the process by 

suggesting that it had not been sufficiently inclusive. We believe the draft report 

accurately described the rulemaking process, and continue to believe that the 

Agency should have more comprehensively evaluated the proposed cap-and-trade 

rule's impact on children's health. A cap-and-trade program, while reducing 

overall emissions, can result in geographically uneven distributions of emissions. 

The proposed rule did not include an analysis of where or how likely such varying 

mercury emissions and resulting depositions could occur, and what impact this 

may have on children's health. The OIG does not agree that the Agency review 

process was inclusive. As we noted in our draft report, according to staff 

involved, the intra-agency work group review process followed in this rulemaking 

varied significantly from past Agency practice and applicable guidance for Tier 

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One rules. Given this rule's far-reaching national implications for human health, 

the environment, and the economy, the OIG believes it was important for the 

Agency to have been more inclusive of available Agency expertise and external 

stakeholder input to develop this rule. The Agency's complete response to the 

draft report and our evaluation of its response are in Appendix E. 

36 
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Timeline of Events Related to 

Development of Mercury Rule 

Appendix A 

\..... .... ·.··.Qitte'• ;.· .•. ·.·;···· \ .•. ;. < \ . •·.····· \} • /· Ell~!!{ . ~ ;• ,;<., November 15, 1990 President signs CAA Amendments of 1990. Section 112 requires EPA 

studies of mercury and Hazardous Air Pollutant emissions from utilities. I 

I 

December 1997 EPA issues "Mercury Study Report to Congress." Emissions trading 

discussed as a control option. 

February 1998 EPA issues "Study of Hazardous Air Pollutant Emissions from Electric ! 

Utility Steam Generating Units." Defers decision on whether regulation of 

util~ies is necessary and appropriate under CAA section 112. 

July 11, 2000 National Academy of Sciences releases report, "Toxicological Effects of I 

Methylmercury," which concludes that EPA's reference dose for i methylmercury is a scientifically defensible level. Estimates that 60,000 

newborns a year could experience neurological damage due to mercury. I 

December 2000 EPA Issues Federal Register Notice making final determination that i regulation of mercury from utilities under CAA section 112 is "appropriate ! and necessary." Discusses cap-and-trade as an option but states that I 

I such an approach must protect local populations close to a source. I 

August 1, 2001 First meeting of Utility MACT working group. Charge to the Group is to I 

I develop a MACT standard. Explicitly directed not to consider trading. 

July 2002 Clear Skies Act of 2002 introduced in the Senate and House of 

Representatives. Proposed a multi-pollutant approach to controlling so,, 

NOx, and mercury emissions from power plants. 

August 28, 2002 EPA contractor memo outlines options for developing proposed MACT 

floor. 

October 2002 Utility MACT working group issues final report. Consensus not reached. ' 

AdditionaiiPM runs recommended based on MACT emission limit 

proposals from stakeholder groups. I 

February 27, 2003 Initial meeting of intra-agency work group (one of two total meetings). 

Analytical blueprint prepared for group addresses traditional MACT, not 

cap-and-trade, and identifies minimum analyses needed. i 

February 27, 2003 Clear Skies re-introduced in House and Senate as Clear Skies Act of I 

! 2003. ! March 4, 2003 WEST Associates issues white paper proposing multi-variability method I 

' for determining MACT floor, presented at last meeting of Utility MACT 

working group. Paper presented to FACA at its last meeting. Method I 

eventually adopted by EPA but with some changes. I 

March 4, 2003 Last meeting of Util~y MACT working group. April meeting canceled by 

EPA; group had planned to discuss results of recommended IPM runs. I 

March 14, 2003 Briefing provided to Administrator Whitman. Presentation states EPA will 

continue to develop a section 112 MACT standard unless Congress 

removes the requirement. 

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!>' .{ Oate.· > • ;Y >·" .• •. >.(· ... >~~~ < ' ~vel\f· . < •• \ ............ <. / \ · 

April 1, 2003 EPA cancelled last FACA working group meeting. E-mail indicates runs 

not yet available, and meeting would be rescheduled at a later date. 

August7,2003 Second (and final) intra-agency work group meeting held, reviewing draft 

preambles. Several MACT emission limits proposed, none of which 

match those in published proposed rule. 

November 4-5, 2003 E-mails between EPA officials discuss efforts to establish MACT floor 

resulting in mercury emissions of 34 tons per year, based on IPM runs 

using various proposed MACT emission limits. 

November 26, 2003 EPA memo to file explaining MACT floor (based on WEST Associates 

method). 

December 15, 2003 "Regulatory Flexibility Act Analysis" entered in Docket. 

December 2003 EPA contractor issued memorandum discussing beyond-the-floor 

analysis. 

December 15,2003 Proposed mercury rule signed. 

January 2004 EPA Report on Benefit Analysis entered in Docket. 

January 28, 2004 "Energy and Economic Impact Analysis" entered in Docket. 

January 30, 2004 Proposed mercury rule published in the Federal Register. 

March 16, 2004 Supplemental Notice issued to the original proposed rule providing 

procedures for implementing cap-and-trade proposal. -

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Appendix B 

OIG's Request for Documents Related to 

Development of Utility MACT 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

OFFICE OF INSPECTOR GENERAL 

OFFICE OF PROGRAM EV,~LUAT!ON 

1301 CONSTITUTION AVENUE, N,W,(2460T) 

EPA WEST BUILDING 

WASHINGTON, DC 20004 

November 15, 2004 

MEMORANDUM 

Subject: Document Request for Assignment Number 2004-1021 - Development of the 

Proposed MACT for Utility Units 

To: Jeffrey Holmstead, 

Assistant Administrator for Air and Radiation 

From: Kwai Chan, /s/ 

Assistant Inspector General for Program Evaluation 

This memorandum is a formal request to you and your staff cc'ed below for several documents 

that we need in order to complete our work on the subject evaluation, The majority of these 

documents have already been requested and are listed again herein, In addition, we are 

requesting specific information (see item 7 below) not previously requested that is needed for us 

to fully and comprehensively address our evaluation objectives. We request that you provide ns 

with the following infom1ation by November 26, 2004, in order that this information can be 

fully considered in our review: 

I, Any and all statistical analysis and related internal correspondence for the two 

MACT IPM nms conducted in November 2003, including electronic records, that 

are not included in the docket 

2, Any and all written OGC analysis conceming use of Section Ill vs. Section 112, 

both for the December 2000 findings and detennination and the January 2004 

proposed rule, including electronic records, 

}, Any and all documentation showing final intra-agency concurrence (or equivalent) 

39 
792 


27172.722

for issuing the proposed rule, including electronic records. 

4. Any and all written comments resulting from the intra-agency review process, 

including electronic records. 

5. The analysis related to children's health that was specifically referred to in the 

proposed rule's preamble on page 4715 of the Federal Register Notice. 

6. The Agency analysis determining the origination of Latham and Watkins language 

that was included in the proposed rule's preamble, and 

7. Any and all internal and external Agency correspondence or other written 

communications related to the development of the MACT floor that were developed, 

transmitted, and/or received during the period October 15, 2003 through December 

15, 2003, including e-mails meeting the defmition of Federal Records. 

We appreciate your prompt response to this request. Please contact Jim Hatfield, Assignment 

Manager, at 919-541-1030, or Carolyn Blair, Project Manager, at 919-541-7702, to coordinate 

the submittal of information related to this request. If any of the above information does not 

exist please indicate that fact in your response. 

cc: Robert Brenner, Deputy Assistant Administrator for Air and Radiation 

Bill Wehrum, Office of the AA for OAR 

Jason Burnett, Office of the AA for OAR 

Stephen Page, Director, OAQPS 

Sally Shaver, Director, Emissions Standards Division, OAQPS 

Bob Wayland, Combustion Group Leader, ESD, OAQPS 

William Maxwell, Principal Rulemaking Contact, Proposed MACT for Utility Units, ESD, 

Nikki Tinsley, Inspector General 

Eileen McMahon, Assistant Inspector General for Congressional and Public Liaison 

Mark Bialek, Counsel, OIG 

40 
793 


27172.723

Status of Agency's Response to DIG's Request for Documents 

Related to Development of Utility MACT 

Item Requested Status 

I. Any and all statistical analysis and related I. We received limited information after the ~ internal correspondence for the two MACT draft report was provided to the Agency for [ 

I 

IPM runs conducted in November 2003, comment. Specifically, we were provided 

including electronic records, that are not copies of Agency e-mails that discussed how 

included in the docket. the information used in these MACT IPM 

runs was developed. 

2. Any and all written OGC analysis 2. Since this was a legal issue before the ! 

concerning use of Section Ill vs. Section courts, we determined that we would not 

112, both for the December 2000 findings address this, so the infonnation was not 

and determination and the January 2004 needed. 

proposed rule, including electronic records. 

3. Any and att documentation showing final 3. No documentation provided. 

intra-agency concurrence (or equivalent) for 

issuing the proposed rule, including 

electronic records. I 

4. Any and att written comments resulting 4. No documentation provided. I from the intra-agency review process, I 

including electronic records. i 

5. The analysis related to children's health 5. Additional information in general was 

that was specificatty referred to in the provided after the draft report was issued, 

proposed rule's preamble on page 4715 of but no analysis on children's health specific 

the Federal Register Notice. to this rule was included. 

6. The Agency analysis determining the 6. The Agency pointed out the information 

origination of Latham and Watkins language in the docket related to this issue, but did not 

that was included in the proposed rule's provide specific Agency analysis. Since this 

preamble, and issue was related to inter -agency review 

process, which is controlled by OMB, we 

did not futty address this issue (See Scope 

Limitation in Chapter 4 of this report.) 

41 
794 


27172.724

7. Any and all internal and external Agency 

correspondence or other written 

communications related to the development 

of the MACT floor that were developed, 

transmitted, and/or received during the 

period October 15, 2003 through December 

15, 2003, including e-mails meeting the 

definition of Federal Records. 

42 

7. No documentation or response received 

other than the limited information in the emails provided for Request I above. 

27172.725

Appe

Different MACT Floor Proposals 

FBC 

(sub-Bit. FBC • 

Source FSC +Bit) Lignite 

EPA Proposed 

Rule NA NA NA 

FACAEnvironmental 0.190 NA NA 

FACA· 

Industry 2.000 NA NA 

FACA • State & 

Local ·Option 1 NA NA NA 

FACA • State & 

Local • Option 2 NA NA NA 

FACA· Clean 

Energy Group NA 0.320 12.0 

Clean Alr Task 

Force [4} NA NA NA 

Abbreviations 

Bit.: Bituminous 

FACA: Federal AdvisoryCommitleeAct 

FBC: Fluidized Bed Combustion 

lbfTbtu: pounds per Trilli:>n Brnish thermal units 

IGCC: Integrated Gasification Combined Cycle 

MACT: Maximum Achievable ContrOl Technology 

NA: Not Applicable 

Emission Limits (Input base ·lbsfTbtu) 

Process Sub-Categories Coal T)l>O Sub-Categories 

Bit.· Bit.• Bit.· Sub·Bit. Sub· CoaJ E

Other Hot Wet Saturated IGCC +Bit. Bit. Bit. Lignite Refuse E

NA NA NA NA 19.0 NA 2.000 5.800 9.200 0.4 

0.210 [2] NA NA NA NA NA NA NA NA NA 

NA 3.700 3.200 2.200 NA NA NA 4.200 6,500 NA 

NA NA NA NA NA a.aoo NA NA NA NA 

NA NA NA NA NA OAOO NA NA NA NA 

NA NA NA NA NA 1.223 NA NA 9.091 NA 

NA NA NA NA 4.9 NA 0.420 1.500 4.500 0.1 

Notes: 

1 Estimate based on Integrated Planning Model results. 

Applied to all unns except FBC 

Based on estimates dewloped by Northeast States for Coordinated Air Use Management. 4 Clean Air Task Force preferred a MACT with no sub-categorization but re-computed a MACT floor based 

EPA's proposed subcategories. 

Based on Integrated Planning Model run and .includes co-benefit reductions from Clean Air Interstate Rule

Based on calculations performed by the industry group. 

43 
796 


27172.726

Appendix D 

EPA's Rule Development Process 

EPA actions are assigned to one of three tiers based on the nature of tbe anticipated issues and 

the level of cross-Agency interactions needed to ensure a quality action. The proposed rule is a 

Tier one rule and meets the following criteria. 

tt11r: 1 tritiJri~: ~dmtnlsJI'at(lr~ Pr~•~'A~'tt~lls \ < < < ,> .. <.\ ..... ··•· .· ....... < .···• •·· • •·. 

t~l!! tie~ ~m. i~91W~ tl?P ~c_lloM 1!\at clelr!sO,d thlron~ol!l!J: lnvotvamentoJ l~e A<fflli~ll;trll~r·&t.lffl(le .~nd 

~~e~s;v~ (llos~f.P<9E!nc~ i~v:~)ve~!lnt.or\. thEi.f»>_!t.<\f tltaAs!tl$jaf.1U.~eglonill~'l!flll~lat!'att:i~s. · · \ •• 

Factors to consider in making a judgment about placing an action in Tier 1 are: 

major cross Agency or cross-media policy implications or precedents 

potential for major or precedent-setting implementation issues 

potential for major cross-Agency, cross-media, or inter-agency controversy 

potential for major economic impact on other levels of government or the regulated community 

highly controversial in terms of external interest 

ongoing, formal involvement of the Agency's highest level of management (Administrator, 

Deputy Administrator) is necessary or desired 

presents a significant opportunity for the Agency to advance the Administrator's priorities 

Action should be placed in Tier 1 if ... 

science issue(s) are precedent setting and controversial 

economically significant per Executive Order 12866 (i.e.,> $100 million), unless the program 

office can justify placement in Tier 2 

economics issue(s) are precedent setting and controversial 

The program office develops the proposed rule, which may take months to years depending on 

the complexity of the rule, priorities, and court/statutory deadlines. Rule development follows 

five major stages, as outlined in the Agency's Action Development Plan. The first stage is 

determining the proper tier for the action based on the criteria outlined above. The following 

table describes the five stages of an Action Development Plan. 

44 
797 


27172.727

~~~"~ ~aJ()r;$t~g~~ti~ ~ti9n,()~v~t(l#~~nt,f»tah' '.'.:"······ .. \<1 

Stage 1. Tiering the Action 

Understand tiering 

Place action in the appropriate tier 

Obtain tiering approval 

Stage 2. Developing the Proposed Rule or Draft Action 

Charter the workgroup 

Get the workgroup underway 

Prepare the preliminary analytic blueprint and get early guidance from senior management 

Prepare the detailed analytic blueprint 

Senior management approval of analytic blueprint 

Complete data gathering, consultation, peerreview, analyses, and options development 

Select Options 

Oevelop the proposed action by preparing preamble, rule, and supporting documents 

Conduct Final Agency Review to ensure senior management approval 

Office of Policy, Economics, and Innovation review for rules deemed as "significant" under 

Executive Order 12866 

Stage 3. Requesting OMB Review for Proposed and Final Actions (if necessary) 

Determine if OMB review is necessary. Only those regulatory actions designated "significant" 

under Executive Order 12866, "Regulatory Planning and Review" are subject to review by OMB 

(e.g., actions having an annual effect on the economy of $100 million) 

Prepare regulatory action for submission to OMB 

Address OMB's comments 

. Docket the OMB review process 

Stage 4. Requesting the Administrator's Signature and Publishing an Action 

Request the Administrator's signature 

Publish the action in the Federal Register and open docket(s) 

Stage 5. Developing the Final Action and Ensuring Congressional Review 

Receive public comments 

Consider and address public comments 

Determine next steps 

Submit actions to Congress under the Congressional Review Act or the Courtesy Copy Policy 

45 
798 


27172.728

Appendix E 

Agency Comments to the Draft Report and 0/G Evaluation 

MEMORANDUM 

SUBJECT: 

FROM: 

TO: 

DATE: 

Comments on the December 17, 2004 Draft Evaluation Report Entitled, 

Additional Analyses of Mercury Emissions Needed Before EPA 

Finalizes Rules for Coal-Fired Electric Utilities 

Jeffrey R. Holmstead 

Assistant Administrator for Air and Radiation 

U.S. Environmental Protection Agency 

William H. Farland, PhD 

Acting Deputy Assistant Administrator for Science 

Office of Research and Development 

U.S. Environmental Protection Agency 

Nikki Tinsley 

Inspector General 

U.S. Environmental Protection Agency 

January 24, 2005 

Thank you for giving us the opportunity to review the draft report referenced above and 

to open dialogue with OIG staff. We have substantial concerns with the referenced draft 

including several inaccuracies and flaws that we feel must be addressed before the report 

is finalized. This memorandum briefly summarizes our major concerns. 

Agency scientists and experts know a great deal about mercury: what are the sources, 

both domestically and internationally; where does mercury in this country come from; 

what is the chemistry that converts mercury deposited on the land and in the water into 

mercury that becomes available to the food chain; what are the routes of exposure in this 

country to mercury; what are the potential impacts of controls on that exposure; and what 

is the status of the various technologies now being studied. 

While some questions remain in our understanding of many of these linkages, this will 

not prevent the Agency from regulating mercury from power plants, and it will do so as 

effectively as possible, informed by the full body of knowledge it now possesses. The 

Agency also recognizes that mercury emissions from facilities as complex as coal-fired 

power plants should not be considered in isolation of the other efforts to reduce air 

pollution; hence the Administration's strategy to further control S02 and NOx while 

instituting new, specific regulations for mercury. The Agency believes that such a 

46 
799 


27172.729

a strategy can deliver significant overall health benefits to a broad segment of the American 

public. 

EPA strongly urges the IG to take the broad base of information we know about mercury, as 

well as the outstanding unanswered questions, into consideration when developing the final 

report. 

1. The draft report criticizes the rulemaking process as being incomplete even before a 

final rule is issued. This critique rings hollow given the iterative nature of rulemaking. The 

rulemaking process consists of a proposed rule, a public comment period and often additional 

information before final decisions are made. The IG characterized the process as incomplete 

before the process had finished. For example, a number of the issues regarding benefit-cost 

analysis raised in the draft report are issues that the Agency is working on as evidenced by its 

Notice of Data Availability on November 30,2004. 

OIG Response: Our review was initiated at the request ofseven U.S. Senators, who asked 

that we complete this review in sufficient time to allow the Agency to address any issues 

raised in our report. We have added information to the Scope and Methodology section in 

Chapter 1 of the Final Report explaining that our review was completed while the Agency 

was still in the process of finalizing the rule. Accordingly, our report reflects findings and 

observations about the status of the process at the time we completed our review. We look 

forward to seeing the results of the Agency's additional cost-benefit analyses, as 

recommended in our report. 

2. The draft report inaccurately suggests that US power plant mercury emissions 

represent a large part of the human exposure problem. Most exposure to mercury comes 

from eating fish from the world's oceans and the mercury in these fish comes from a variety of 

sources released over many years, including natural emissions like volcanoes, and 

anthropogenic emissions from many countries, representing emissions from a variety of 

sectors, in addition to emissions from US power plants. It is because US power plants are part 

of the larger problem that EPA has proposed, for the first time ever, to require reductions from 

this sector. 

Given the global nature of mercury exposure and the uncertainty in the time to realize benefits 

from current emission reductions, the action to reduce mercury emissions from power plants 

must be seen in the larger context of all the activities EPA and others in the international 

community are implementing to reduce exposure to mercury. 

47 
800 


27172.730

OIG Response: Our draft report did not suggest that mercury emissions from U.S. power 

plants represent a large part of the human exposure problem. Power plants are one of 

many sources of mercury emissions. The primary o~;ective of our review was to assess 

EPA 's development of the proposed rule for regulating mercury emissions from coal-fired 

electric utility units, and we included information in our draft report on mercury emissions 

and mercury health effects for background purposes. Nonetheless, we have included 

additional information in Chapter I of the Final Report to put total U.S. mercury and U.S. 

power plant emissions in the context of global mercury emissions. We understand that 

primmy route of human exposure to mercury is through the consumption offish and that 

the Centers for Disease Control and Prevention surveys indicate that seafood is the 

predominant type of fish consumed by women of child-bearing age and children. 

However, certain subgroups, such as Native Americans, eat more fresh-water fish and may 

be more susceptible to merCUIJ' exposure than others. We added this information to the 

background section of our final report. 

3. The draft report does not comprehensively and accurately describe how the proposed 

cap-and-trade system would work, leading the reader with misimpression about what our 

experience and modeling has taught us. The draft report fails to recognize that a 

cap-and-trade system requires emissions reductions on a concrete time line of declining caps, 

thus leading to continual reduction of emissions and promotion of new technologies. It also 

fails to acknowledge that, under this system, the largest emitters typically will be the first to 

reduce their mercury emissions and will generally achieve the greatest level of reductions. 

The draft report criticizes the cap-and-trade proposal for not requiring the installation of 

mercury-specific controls until 2018, but this is inaccurate and reflects a misunderstanding 

about how cap-and-trade works. The report should recognize the fact that it is reductions in 

mercury emissions that will lead to improvements in public health and these reductions will 

occur much earlier than 2018. Moreover, neither the Maximum Achievable Control 

Technology (MACT) approach nor the cap-and-trade approach would require any particular 

technology for controlling mercury. Either approach would require power plants to meet 

certain standards for mercury control, and then let individual plants find the best way to meet 

those standards. 

OlG Response: One of the objectives of our review was to evaluate whether the proposed 

mercury cap-and-trade rule was sufficientZy protective of public health. As a result, we 

highlighted certain concerns with the rule as proposed. As such, we limited our focus of 

the mercury cap-and-trade proposal to concerns about the interim cap level, the potential 

for hot spots formation, the safety valve provision, the exemption of small emitters, and 

tribal impacts. 

48 
801 


27172.731

Our draft report portrayed an accurate representation of how the mercury cap-and-trade 

program worb. While the proposed mercury cap-and-trade rule should ultimately result 

in emissions reductions, we do not agree that the proposal provides a "concrete timeline 

of declining caps. " For example, the proposed rule provides an interim cap that is based 

on co-benefits from existing technologies and can be achieved without the implementation 

of mercury-specific controls. Since the interim cap for mercury emissions can be achieved 

without mercury-.lpecific controls, the proposed rule may not adequately promote the use 

of new technologies. Also, the only other mercury cap is the 2018final cap, and EPA 

modeling indicates it may not be met in 2018 due to the banking provisions of the 

proposed mercury trading program. Finally, our draft report noted that neither the 

proposed cap-and-trade nor the MACT option require the use of any specific technology. 

While EPA has experience with cap-and-trade programs such as the Acid Rain program, 

there are differences in the transport and fate ofS02 and mercury emissions which need 

to be addressed in a cap-and-trade approach to controlling mercury emissions. For 

example, S02 emissions are primarily deposited regionally and globally, while mercury 

can deposit locally. Additional differences between these two cap-and-trade programs 

were highlighted in Chapter 3 of the draft report. 

4. The draft report incorrectly characterizes the calculation of the MACT standard. The 

draft report did not independently calculate the MACT floor, but instead simply relied on 

assertions made by critics of the proposal as the basis for their critique. The proposed MACT 

floor was calculated in accordance with the requirements of CAA Section 112( d) by basing the 

standard on what the top performing 12 percent of units were achieving in practice, taking into 

account subcategorization and variability. 

Contrary to the claims in the draft report, the Agency did investigate beyond-the-floor MACT 

alternatives and did propose a beyond-the-floor standard where technology was found to be 

available (i.e., Integrated Gasification Combined Cycle (IGCC) subcategory). 

49 
802 


27172.732

0/G Response: The DIG did not inaccurately characterize the calculation of the MACT 

floor. Our analysis was based on discussion with a number of EPA stakeholders and EPA 

officials, and review of supporting documentation. We found evidence that although the 

MACT floor was ostensibly based on data from the top pe':forming 12 percent of units, this 

data was analyzed with a final target already in mind, i.e., 34 tons. As stated in the 

Agency's Comment 5 to our draft report, this "floor" of 34 tons was obtained during the 

Clear Skies legislative process. Accordingly, we do not consider this floor to be based on 

an unbiased analysis of what the top pe1jorming 12 percent of units were achieving. 

With respect to IGCC units, our review focused primarily on the development of the 

standards for existing units. Of the over 400 coal-fired power plants in operation in the 

U.S, two are IGCC plants. Although EPA did 1wt propose a beyond-the-floor standard 

for existing IGCC units, EPA proposed an emission limit for new IGCC units that was 

below the calculated floor for IGCC units and was based on EPA's determination that 

mercury reduction of 90 percent could be obtained for this subcategory through the use of 

carbon bed technology. 

5. The draft report suggests that the proposed rule was flawed because other regulatory 

alternatives that would achieve emissions levels lower than about 34 tons per year were 

not developed or proposed. In particular, the draft report makes much of the fact that the 

MACT proposal was developed with the goal of achieving a nationwide emissions level from 

affected power plants of about 34 tons per year. The report fails to consider the fact that EPA 

had developed extensive infonnation about mercury emissions and control techniques in the 

power sector during the MACT regulatory development process and during the development of 

the Clear Skies initiative. That work caused us to conclude that mercury reductions could, in 

fact, be achieved in the power sector over the 3-4 year MACT compliance period specified by 

the statute. However, these reductions would not come for the most part from mercury-specific 

controls (such as activated carbon injection). Extensive work conducted by the Office of Air 

and Radiation and the Office of Research and Development indicated that mercury-specific 

controls will not become readily available for commercial application to this industry until 

2010 or later -well beyond the MACT compliance period. Consequently, the proposed rule is 

predicated on the assumption that virtually all mercury reductions during the MACT 

compliance period would have to be accomplished as a co-benefit of installing air pollution 

controls designed to remove SO, or NOx. As part of the Clear Skies effort, EPA had 

extensively studied the capacity of the power sector to install SO, and NOx controls during the 

period up to 20 I 0. That work showed that 34 tons per year was the lowest level of mercury 

emissions that we could reasonably expect the power sector to achieve through the aggressive 

application of SO, and NOx controls up to 2010. Further, as a part of the FACA process 

established for this rulemaking, industry submitted what they thought would be possible under 

a true co-benefit approach (i.e., no mercury-specific controls). Their estimate was that 36 tons 

per year of mercury would be emitted under a MACT approach. The EPA proposal is 

grounded in careful analysis as to what levels of mercury control reasonably can be expected 

over the MACT compliance period. 

50 
803 


27172.733

0/G Response: Our draft report concluded that the MA CT development process was 

compromised for several reasons. This included the.fact that several MACTfloor 

proposals were lower than the EPA 's proposed MA CT rule, including several proposals 

developed by EPA in trying to achieve a floor that would result in annual emissions of 34 

tons. This included two EPA !PM runs that showed national emissions of 29 tons and 27 

tons, that were not included in the rulemaking docket or available for public comment. 

While the Agency has conducted analysis to determine the co-benefit of S01 and NOx 

controls, we do not believe this meets the requirements ofCAA section 112(d) in 

developing the MACTstandard. For example, the co-benefit is based on an average 

paformance of all units, not just the best performers. We continue to believe the Agency 

should conduct additional analyses before finalizing the rule. As noted in the draft report, 

the Government Accountability Office is conducting a review of technology-related issues 

for the proposed mercury rule. 

6. The draft report fails to recognize the nature of the regulatory development process 

and incorrectly states that EPA "did not adequately evaluate the environmental health 

effects of the proposed rule on children." We have made it clear from the start of the 

rulemaking process that the health effects of greatest concern are possible developmental 

effects in fetuses and young children exposed to unsafe levels of methylmercury. Unlike most 

other rules that EPA develops, this rulemaking is singularly directed at developing an 

appropriate regulatory approach for addressing the potential impacts on children. Evidence of 

this can be seen in EPA's first guiding principle in the development of a final mercury rule 

which states that the rule will concentrate on the need to protect children and pregnant women 

from the health impacts of mercury. 

Consistent with this principle, EPA Office of Air and Radiation participated in an ongoing 

dialogue with the Children's Health Protection Advisory Committee (CHPAC) and responded 

to CHPAC's recommendations on mercury exposure in children. Further, EPA and others 

have conducted extensive work on the health effects of mercury for the developing fetus and 

young children, including a National Academy of Sciences review completed in 2000. The 

Inspector General's draft report misses this key point. 

51 
804 


27172.734

0/G Response: We do not believe we failed to recognize the nature of the rulemaking 

process. Further, the Agency should have more comprehensively evaluated the proposed 

cap-and-trade rule's impact on children's health. A cap-and-trade program, while 

reducing overall emissions, can result in geographically uneven distributions of emissions. 

The proposed rule did not include an analysis of where or how likely such varying 

mercury emissions and resulting depositions could occur, and what impact this may have 

on children's health. 

Children 's Health Protection Advismy Committee members did not characterize their 

interaction with the Agency as an ongoing dialogue. Committee members told us that the 

Agency's response to their concerns with the proposed rule did not satisfactorily address 

their recommendations. 

7. The draft report improperly characterizes the process by suggesting that it has not 

been sufficiently inclusive. EPA has held dozens of high-level inter-office and external 

meetings on this rule. This inclusive process was needed both because the rule has 

far-reaching national implications for human health, the environment, and the economy and 

also because a well-informed decision on an issue this complicated requires hearing diverse 

perspectives. While there is always room to improve communications within and with those 

outside of EPA, there is little basis to fault the Agency in this case. 

0/G Response: The OIG does not agree that the Agency review process was inclusive. 

As we noted in our draft report, according to staff involved, the intra-agency work group 

review process followed in this rulemaking varied significantly from past Agency practice 

and applicable guidance for Tier One niles. Specifically, the work group process 

followed in this rulemaking was unusual in its short duration, infrequent meetings, late 

start with respect to the final rule deadline, and overall lack of communication and 

feedback between the work group and Agency decision makers. Further, work group 

members were not given the opportunity to review and comment on an entire draft 

proposal before it was published in the Federal Register. For example, staff from the 

Office of Enforcement and Compliance Assurance were never given a draft of the 

proposed rule to review or comment on, thus this office could not assess the adequacy of 

the proposed rule's monitoring, record keeping, or reporting provisions as it typically 

does for Tier One MAC'Fs. With respect to meeting with external stakeholders, tribal 

representatives told us that they were not consulted during the development of the 

proposed cap-and-trade option. Given this rule's far-reaching national implications for 

human health, the environment, and the economy, the 0/G believes it was important for 

the Agency to have been more inclusive of available Agency expertise and external 

stakeholder input in developing this proposed rule. 

52 
805 


27172.735

Again, thank you for the opportunity to review the draft report. We would be happy to work 

with you and your staff to ensure that you promptly receive all the information and analysis you 

need to finalize the report. The final report should include an improved discussion of(!) the 

global nature of mercury exposure and the uncertainty in the time to realize benefits from 

current emission reductions; (2) how a proposed cap-and-trade system would require emissions 

reductions on a concrete timeline; (3) the approaches to calculation of the MACT floor; (4) the 

substantial effort EPA devoted to evaluating the risk of mercury exposure on children; and (5) 

the inclusiveness of EPA's process towards reaching a final rule. 

OIG Response: The Agency's comments have been included in the final report as 

appropriate. We appreciate the efforts of both the Office of Air and Radiation and the 

Office of Research and Development in working with us to clarifY certain technical issues 

and in providing prompt input so that we could issue our report in a timely manner. 

53 
806 


27172.736

Distribution 

Acting Administrator (!lOlA) 

Assistant Administrator for Air and Radiation (6101A) 

Deputy Assistant Administrator for Air and Radiation (6101A) 

Appendix F 

Acting Deputy Assistant Administrator for Science, Office of Research and Development 

(AIOIR) 

Acting Deputy Assistant Administrator for Management, Office of Research and Development 

(AIOIR) 

General Counsel, Office of General Counsel (40IOA) 

Agency Followup Official (the CFO) (2710A) 

Agency Followup Coordinator (2724A) 

Audit Followup Coordinator, Office of Air and Radiation (6102A) 

Audit Followup Coordinator, Office of Research and Development (Al02R) 

Associate Administrator for Congressional and Intergovernmental Relations (l301A) 

Associate Administrator for Public Affairs (I lOlA) 

Director, Office of Air Quality Planning and Standards (C404-04) 

Deputy Director, Office of Air Quality Planning and Standards (C404-04) 

Audit Liaison, Office of Air Quality Planning and Standards (C404-2) 

Inspector General (241 0) 

54 
807 


27172.737

OFF'lCE OF INSPECTOR GENERAL 

Evaluation Report 

Monitoring Needed to Assess 

Impact of EPA's Clean Air 

Mercury Rule on Potential Hotspots 

Report No. 2006-P-00025 

May 15,2006 
808 


27172.738

Report Contributors: Rick Beusse 

Carolyn Blair 

Hilda Canes 

Abbreviations 

CAMR 

CMAQ 

EPA 

Hg 

IPM 

km 

MACT 

MDN 

mg/kg 

OIG 

Cover photo: 

Susan Charen 

Sarah Fabirkiewicz 

James Hatfield 

Erica Hauck 

James Van Orden 

Clean Air Mercury Rule 

Community Multiscale Air Quality 

Environmental Protection Agency 

Mercury 

Integrated Planning Model 

kilometer 

Maximum Achievable Control Technology 

Mercury Deposition Network 

milligram per kilogram 

Office oflnspector General 

A fisherman holding a walleye, a predator fish for which mercury 

contamination is a concern (photo courtesy EPA). 
809 


27172.739

U.S. Environmental Protection Agency 

Office of Inspector General 

At a Glance 

Monitoring Needed to Assess Impact of EPA's 

Clean Air Mercury Rule on Potential Hotspots 

What We Found 

2006-P-00025 

May 15,2006 

EPA brought significant scientific, technical, and modeling expertise to bear in 

developing a specific methodology to consider the potential for mercury hotspots. 

Several uncertainties associated with key variables in the analysis could affect the 

accuracy of the Agency's conclusion that the Clean Air Mercury Rule (CAMR) 

will not result in "utility-attributable" hotspots. We noted: 

gaps in available data and science for mercury em.issions estimates, 

limitations with the model used for predicting mercury deposition, 

uncertainty over how mercury reacts in the atmosphere, and 

uncertainty over how mercuty changes to a more toxic fonn in waterbodies. 

Two recent studies support the need for additional monitoring to ensure that EPA's 

analysis has properly estimated the contribution of local. regional, and global 

sources on U.S. deposition. These studies arc "Afechanism,y <?[Mercury Removal 

hy 0 3 and Off in the Atmosphere," published in Atmospheric Enviromnent in June 

2005; and "Sources of kfercw:v Wet Deposition in Eastern Ohio, USA,., submitted 

for publication in a scientific joumal in February 2006. Results of both studies 

were not available until after EPA issued CAMR in March 2005, and thus could 

not have been considered in EPA's deliberations on CAMR. Although EPA 

indicated in CAMR that it would monitor the impact of the cap-and-trade mle on 

mercury deposition, the Agency has not yet developed a monitoring plan for this 

purpose. \Vithout field data from an improved monitoring network, EPA's ability 

to advance mercury science will be limited and "utility-attributable" hotspots that 

pose hcnlth risks may occur and go undetected. 

Based on our interpretation ofCAMR, EPA could not take action to mitigate a 

mercury hotspot unless the Agency first determined that the hotspot was solely 

"utility-attributable," Therefore, EPA could not require additional utility emission 

reductions if utilities contributed significantly, but not solely, to a mercury 

hotspot. This could limit EPA's ability to mitigate lmman health hazards by 

reducing potentially harmful levels of mercUiy in waterbodies and fish tissue. 

This could also limit EPA's ability to reduce the number ofwatcrbodies with tish 

consumption advisories. 

What We Recommend 

We recommend that EPA develop and implement a mercury monitoring plan to 

(1) assess the impact ofCAMR, if adopted, on mercury deposition and fish tissue; 

and (2) evaluate and refine mercnry estimation tools and models. Further, if 

CAMR is adopted after the mle reconsideration process is complete, we 

recommend that EPA clarify in the final mle that the "utility-attributable" hotspot 

definition docs not establish a prerequisite for making future revisions to CAMR. 

fn response to the draft report, the Agency agreed that additional mercury 

monitoring is needed aud explained that CAMR docs not establish the "utility~ 

attributable" hotspot definition as a prerequisite for future changes to CAMR. 
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MEMORANDUM 

SUBJECT: 

TO: 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

May 15,2006 

Monitoring Needed to Assess Impact of EPA's 

Clean Air Mercury Rule on Potential Hotspots 

Report No. 2006-P-00025 

William L. Wehrum 

Acting Assistant Administrator for Air and Radiation 

OFFICE OF 

INSPECTOR GENERAL 

This is our report on the subject evaluation conducted by the Office ofinspector General (OIG) 

of the U.S. Environmental Protection Agency (EPA). This report contains findings that should 

help EPA to better monitor the impact of the Clean Air Mercury Rule and refine performance 

standards under the rule, if necessary. This report represents the opinion of the OIG and the 

findings in this report do not necessarily represent the final EPA position. Final determinations 

on matters in the report will be made by EPA managers in accordance with established 

procedures. 

Action Required 

In accordance with EPA Manual2750, as the action official, you are required to provide a 

written response within 90 days of the final report date. The response should address all 

recommendations. For the corrective actions planned but not completed by the response date, 

please describe the actions that are ongoing and provide a timetable for completion. Where you 

disagree with a recommendation, please provide alternative actions for addressing the findings 

reported. 

We appreciate the efforts of EPA managers and staff in working with us to develop this report. 

If you or your staff have any questions regarding this report, please contact me at 202-566-0847, 

or Rick Linthurst at 919-541-4909. 

Sincerely, 

~ 

tttt/2/ 

Acting Inspector General 
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Table of Contents 

At a Glance 

Introduction ......................................................................................................... . 

Purpose.......................................................................................................... 1 

Background .................... ... ................................................................... .......... 1 

Scope and Methodology................................................................................. 5 

2 Monitoring Plan Needed to Address Uncertainties 

In EPA's Hotspots Analysis ................................................................................ . 6 

EPA Analyzed Potential for "Utility-Attributable" Hotspots.............................. 6 

Data and Science Gaps Exist for Mercury Emissions Estimates................. 8 

CMAQ Model Uncertainties and Limitations................................................... 9 

Study Finds Different Rates of Atmospheric Chemical Reactions.................. 10 

Uncertainties Noted with Methylation and Bioaccumulation........................... 10 

Study Shows Significant Deposition from Local Sources............................... 12 

Uncertainties Underscore Need for Mercury Monitoring Plan........................ 13 

Conclusion...................................................................................................... 15 

Recommendation........................................................................................... 15 

Agency Comments and OIG Evaluation......................................................... 15 

3 EPA Needs to Clarify Conditions Under Which CAMR 

Performance Standards Can be Tightened ....................................................... .. 17 

EPA Provides "Utility-Attributable" Hotspot Definition.................................... 17 

"Utility-Attributable" Definition Could be Interpreted to Limit EPA's 

Ability to Mitigate Hotspots......... ........................................................... 18 

CAMR and Revision Must be Read Together................................................ 18 

Conclusion . . ..... ............ ..... ................................ .................... ........................ 20 

Recommendation........................................................................................... 20 

Agency Comments and OIG Evaluation......................................................... 20 

A Details on Scope and Methodology..................................................................... 21 

8 Models Used in CAMR Analysis .......................................................................... 24 

C Agency Response to Draft Report....................................................................... 25 

D Distribution............................................................................................................ 28 
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Purpose 

A prior Environmental Protection Agency (EPA) Office oflnspector General 

(OIG) report cited concerns about EPA's limited assessment of the potential for 

mercury hotspots resulting from a cap-and-trade program under the Clean Air 

Mercury Rule (CAMR). We issued this prior report, Additional Analyses of 

Mercury Emissions Needed Before EPA Finalizes Rules for Coal-Fired Electric 

Utilities (Report No. 2005-P-00003), on February 3, 2005. In support ofCAMR, 

EPA conducted a detailed analysis of mercury emissions and deposition and 

concluded that "utility-attributable" hotspots would not occur after 

implementation of the mercury emissions trading program. 

EPA's Water Quality Trading Assessment Handbook defines hotspots as 

"localized areas with unacceptably high levels of pollutants." In this evaluation 

report, however, a hotspot is a waterbody containing consumable fish with 

elevated levels of methylmercury in their tissues. 

We conducted this evaluation to assess the basis for the Agency's determination 

that CAMR would not result in "utility-attributable" hotspots. 

Background 

Mercury (Hg) is released into the atmosphere through natural processes and 

through human activities, such as combustion processes. Once emitted, 

atmospheric mercury undergoes several chemical and physical processes and can 

then be deposited to the ground or waterbodies via wet or dry processes. In wet 

deposition, mercury is deposited by precipitation, such as rain or snow. In dry 

deposition, mercury settles to the earth's surface and sticks to or is absorbed by 

trees, soil, water, or other surfaces. The largest source of airborne mercury 

emissions in the United States is the coal-fired electric utilities industry, 

representing an estimated 40 percent of total U.S. man-made airborne mercury. 

Although airborne mercury is generally not considered to be a serious health 

concern, once mercury enters freshwater and salt-water bodies, it can 

bioaccumulate in fish and other animal tissues in its more toxic form, 

methylmercury. As methylmercury bioaccumulates in the food chain, its 

concentration becomes increasingly higher in animals at the top of the food chain 

(such as larger predatory fish) that consume smaller, contaminated organisms. 

Figure 1-l illustrates the exposure pathway of mercury. 
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27172.743

Figure 1-1: How Mercury Enters the Environment 

...... 

Emissions: 

\\ 

Weiand Drv 

Deposition' 

l..ake Ocean 

Atmospheric 

From Power 

Plants and other 

Mercury lransforms inlx> methylmercury 

SDurc-es 

in soil5: and water, then can 

bloaccumulate in tish 

Impacts • Best documented 

impacts on the 

dewloping fel\1$: 

impaired motor and 

cognitive skil15: 

. """ "'" ~-·l 

Fish consumption is the main route by which methylmercury harms human health. 

Excessive human exposure to methylmercury has been associated with severe 

detrimental neurological and developmental health effects. Research has shown 

that the developing fetus is at risk for impaired motor and cognitive skills. Thus, 

exposure to mercury by women of child-bearing age is of particular concern. 

Most U.S. Fish Advisories Due to Mercury Contamination 

When levels of chemical contamination in tlsh are considered unsafe, States, 

tribes, and territories can issue consumption advisories that may recommend that 

people limit or avoid eating certain species of fish caught in certain places. Each 

State sets its own criteria and decides which bodies of water to monitor. 

Monitored waterbodies may vary from year to year. Fish advisories are voluntary 

State recommendations not governed by Federal regulations. In 2004, 44 States 

issued tlsh advisories for mercury. The number of mercury-related tlsh advisories 

continues to rise as States increase fish tissue testing. 

EPA recently reported in its 2005 Pe1jimnance and Accountabilizy Report that the 

Agency did not meet its goal of reducing the number of overall fish advisories by 

at least I percent fi·om 2002 levels. From 2003 to 2004, the number of mercury 

advisories rose from 2,362 to 2,436, or 3.1 percent. According to the 2004 

National Listing ofFish Advisories, the vast majority (68 percent) offish 

advisories in the United States are due to mercury contamination, as illustrated in 

Figure 1-2. 

2 
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Figure 1-2: Percent of Fish Advisories for Each of the Top Five 

Bioaccumuiatlve Contaminants in 2004 

l:iJ Mercury 1111 PCBs 0 Chlordane 0 Dioxins 1111 DDT & Metabolites 

SoLtrce: 2004 National 

CAMR First Rule for Mercury Emissions from Coal-Fired Utilities 

On March 15,2005, EPA issued CAMR, which established the country's first 

regulation of mercury emissions from coal-fired power plants. CAMR uses a 

declining cap-and-trade approach to regulating coal-fired utilities under 

Section Ill of the Clean Air Act by setting a fixed national cap. Utilities can buy 

and sell credits among one another in a national emissions market. Utilities that 

cannot cost-etiectively reduce emissions may buy allowances from units that 

reduced emissions below established allowance limits. Under CAMR. an interim 

national cap of38 tons per year becomes effective in 2010 and a final annual cap 

of15 tons becomes etiective in 2018. EPA's first cap is based on mercury 

reductions expected to be achieved as a co-benefit of implementing the Clean Air 

Interstate Rule, issued in March 2005. That rule requires utilities to take actions 

to reduce emissions of sulfur dioxide and nitrogen oxides, and those actions are 

also projected to reduce mercury emissions. 

EPA Revised its Prior Regulatory Finding Regarding Utilities 

To use a cap-and-trade program to regulate coal-fired utilities, EPA first had to 

revise a December 2000 regulatory tlnding 1 that indicated it was appropriate 

and necessary to regulate coal-tired utilities under Section 112 of the Clean Air 

Act. This finding required EPA to regulate utilities using a Maximum 

Achievable Control Technology (MACT) standard. MACT standards are 

1 Regulatory Finding on the Ernissions of Ha::ardous Air Pollutants F'rom EJectric Uti/it}' Steam Generating Units, 

December 20, 2000; Vol. 65, No. 245. 

3 
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27172.745

industry-specific, technology-based standards designed to reduce hazardous air 

pollutant emissions. These standards can require facility owners/operators to 

meet emission limits, install emission control technologies, monitor emissions 

and/or operating parameters, and use specified work practices. In March 2005, 

EPA issued a Revision of December 2000 Regulatory Finding, 2 stating that the 

Agency no longer found it appropriate or necessary to regulate utilities under 

Section 112. This released the Agency from the requirement to regulate 

utilities using a MACT standard. EPA issued the finding the same day it 

issued CAMR, which established a mercury cap-and-trade program under 

Section II I. 

For its Revision of December 2000 Regulatory Finding, EPA interpreted 

Section 112(n) to mean that utilities alone had to be the sole cause of a health 

hazard in order to be regulated under Section I 12 and subject to MACT 

standards. Specifically, EPA developed the following "utility-attributable" 

hotspot definition for its revision: " ... a waterbody that is a source of 

consumable fish with Methylmercury tissue concentrations, attributable solely 

to utilities, greater than EPA's Methylmercury water quality criterion of 

0.3 milligrams per kilogram (mg/kg)." 

EPA Response to Petitions for Reconsideration 

Several State agencies and other organizations oppose EPA's adoption of a 

cap-and-trade program for mercury. These groups separately petitioned for 

reconsideration of the Revision of December 2000 Regulatory Finding. Among 

other things, they asserted that, in its analysis, EPA underestimated the impact of 

deposition resulting from local and regional sources and overestimated the impact 

of emissions from global sources. Thus, they argue, some mercury hotspots 

already exist, and requiring sources to comply with MACT standards would 

immediately reduce deposition in those areas. Further, these opponents to the 

cap-and-trade program believe the program could result in new mercury hotspots 

if some utilities bought excess emission credits instead of reducing emissions. 

On October 21, 2005, EPA reopened for public comment certain aspects of its 

CAMR and, in a separate action, reopened for public comment certain aspects of 

its Revision of December 2000 Regulatory Finding. The action to reopen 

comment on CAMR was taken in response to petitions filed by 14 States, 

5 environmental groups, a public utility, and a waste services association. The 

Agency stated that it agreed to reconsider several aspects regarding CAMR. The 

action to reopen comment on EPA's Revision of December 2000 Regulatory 

Finding was based on two petitions, one from 14 States and a second from 5 

environmental groups and 4 Indian tribes. The Agency agreed to reconsider the 

legal issues underlying the decision as well as the methodology used to assess the 

2 Revision of December 2000 Regulatory Finding on the Emissions of Ha:ardous Air Pollutants from Electric Utility 

Steam Generating Units and the Removal '!{Coal- and Oil-fired Electric Utility Steam Generating Unitsji·om the 

Section 112(c) List; Final Rule, March 15,2005. 

4 
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27172.746

amount of"utility-attributable" mercury levels in fish tissue and the public health 

implications of those levels. The Agency also agreed to reconsider how it defined 

a utility hotspot for the purposes of its finding concerning regulation of Utility 

Units under Clean Air Act Section 112. Comments regarding this reconsideration 

were accepted until December 19, 2005. The Agency was still evaluating 

comments at the time our field work ended. 

Scope and Methodology 

We conducted our review from September through December 2005, in 

accordance with Government Auditing Standards issued by the Comptroller 

General of the United States. We performed field work at EPA's Office of Air 

and Radiation in Washington, DC; the Office of Air and Radiation's Office of 

Air Quality Planning and Standards in Research Triangle Park, North Carolina; 

the Office of Research and Development in Research Triangle Park; and the 

Office of Water in Washington. 

To answer our evaluation's objective, we examined: (I) the basis for the 

Agency's "utility-attributable" hotspot definition and the consistency of this 

definition with any prior Agency decisions regarding hotspots; (2) the key 

attributes, assumptions, and limitations of the models used to assess the impact 

of mercury emissions from coal-fired electric utility units under CAMR; and 

(3) the key variables used as inputs to the models as well as the basis for 

selecting these variables. 

To gain an understanding of the definition of"utility-attributable" hotspots, the 

modeling and analyses EPA used to determine the potential for "utilityattributable" mercury hotspots after CAMR, and the inputs and assumptions 

associated with the Agency's analyses, we interviewed EPA staff involved in the 

development ofCAMR or knowledgeable about the processes and models used 

in EPA's analyses. We also interviewed officials from State agencies and 

external organizations familiar with CAMR's development and EPA's hotspots 

analysis. We reviewed data and analyses developed in support of the rule, and 

selected public comments included in the rulemaking docket. We also reviewed 

related information provided by both EPA and non-EPA officials. 

Our analysis focused on the key assumptions and limitations of the Community 

Multiscale Air Quality model, which was used to estimate mercury transport and 

deposition. We did not review in detail the assumptions, limitations, and 

uncertainties associated with the other models used in the Agency's analyses. 

Appendix A provides additional details on scope and methodology. 

5 
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27172.747

As with any modeling assessment, uncertainties may exist. Uncertainties 

regarding EPA's analysis and conclusion that CAMR will not result in "utilityattributable" hotspots include: 

gaps in available data and science for mercury emissions estimates, 

limitations with the model used for predicting mercury deposition, 

uncertainty over how mercury reacts in the atmosphere, and 

uncertainty over how mercury changes to a more toxic form in 

waterbodies (i.e., methylation) and accumulates in fish tissue. 

Two recent studies support the need for additional monitoring to ensure that 

EPA's hotspots analysis has properly estimated the contribution oflocal, regional, 

and global sources to U.S. deposition. These studies are: 

(I) "Mechanisms of Mercury Removal by 0 3 and OH in the Atmosphere," 

Calvert, J.G., Lindberg, S.E., (published in Atmospheric Environment, 

Volume: 39, Number: 18, Page: 3355-3367), June 5, 2005, referred to in 

this report as the "Mechanisms of Mercury Removal Study;" and 

(2) "Sources of Mercury Wet Deposition in Eastern Ohio, USA," Keeler, G.J., 

et al., referred to in this report as the "Steubenville Study" (a peer review 

of the Steubenville Study was completed in December 2005 and the study 

was submitted for publication in a scientific journal in February 2006). 

Results of both studies were not available until after EPA issued CAMR in March 

2005, and thus could not have been considered in EPA's deliberations on CAMR. 

We believe the uncertainties associated with its CAMR analysis underscore the 

need for EPA to develop and implement a plan for monitoring the impact of 

CAMR on mercury deposition and mercury concentrations in fish tissue. Without 

implementation of a monitoring plan and/or improvements to current models, 

"utility-attributable" hotspots that can pose health risks may occur and go 

undetected. 

EPA Analyzed Potential for "Utility-Attributable" Hotspots 

In its Revision of December 2000 Regulatory Finding, EPA states it "does not 

believe that there will be any [utility-attributable] hot spots after implementation 

ofCAIR [Clean Air Interstate Rule] and CAMR.'' EPA's analyses of mercury 

hotspots considered many factors that influence the way mercury is deposited to 

land and waterbodies. For its CAMR analysis, EPA used the Community 

6 
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Multiscale Air Quality (CMAQ) model as the principal tool to predict patterns of 

mercury deposition and as an important part of assessing the potential for "utilityattributable" mercury hotspots under CAMR. 

EPA considers the CMAQ to be the most capable model available for assessing 

the impacts ofCAMR on mercury deposition within the United States. The 

model is designed to estimate pollutant concentrations and depositions over large 

areas, such as the continental United States. The model accounts for variations in 

mercury emissions, differences in the atmospheric reactions of mercury, and the 

impact of those factors on deposition. 

However, there are important limitations associated with some of the inputs EPA 

used in CMAQ for its CAMR analysis. The July 2005 Final Report: Second Peer 

Review of the CMAQ Model, conducted by an independent panel that included 

State, academic, and private organizations, notes the following limitations: 

CMAQ is a modeling system that simulates a wide range of physical, 

chemical and biological processes . .. Some of these processes are well 

understood, some reasonably well understood, and some only poorly 

understood This wide range in the level of knowledge about the 

processes being modeled, and the fact that uncertainties in characterizing 

some of the processes correspond to areas of active research worldwide, 

means that some parts of the model code are sufficiently well established 

as to be considered fixed, while other parts of the code are under 

continuing development. 

Other models also played a role in EPA's analysis ofthe potential for hotspots 

under CAMR by contributing input data to CMAQ (see Appendix B for details on 

some of these other models). For example, a separate model was used to estimate 

the amount of mercury emissions from utilities based on certain economic 

assumptions, and another was used to predict weather patterns. Both the 

emissions and weather data were fed into CMAQ, and CMAQ predictions on 

deposition were fed into another model to estimate the effects of deposition on 

future mercury fish tissue concentrations. 

In its hotspots analysis, the Agency discussed instances where conservative 

assumptions were used to avoid underestimating the impact of utilities. For 

example, in its hotspots analysis EPA did not screen out watersheds in which 

sources of mercury other than air deposition were significant. According to EPA, 

this may result in higher concentrations of methylmercury in fish being attributed 

to power plants than would be the case had EPA been able to account for non-air 

sources. In addition, EPA's hotspots analysis discusses the conservative estimates 

used in determining the oral reference dose for mercury (i.e., an estimate of the 

daily exposure to the human population, including sensitive subgroups, that is 

without an appreciable risk of deleterious effects during a lifetime). The 

reference dose and human exposure information were used to establish the water 

7 
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quality criterion for methylmercury in fish tissue, the criterion used by EPA to 

represent a mercury hotspot. 

Data and Science Gaps Exist for Mercury Emissions Estimates 

While EPA has conducted activities to greatly increase its knowledge of mercury 

emissions from coal-fired utility plants, the Agency acknowledges that some 

uncertainty still exists when estimating total and speciated3 mercury emissions 

and in projecting these emissions after implementation of various control 

technologies. 

CMAQ requires the input of emissions inventory data to predict how emissions 

will transport and deposit. CMAQ was first run with a full emissions inventory to 

establish a base case scenario assuming the presence of all emissions. Next, 

CMAQ was run with emissions from coal-fired utilities removed, in what is called 

a "zero-out" run, to determine the impact of the variable that was zeroed out. 

EPA used this zero-out method to determine that no "utility-attributable" hotspots 

would occur after accounting for emissions reductions expected to be achieved 

from the Clean Air Interstate Rule and CAMR. 

The utility emissions input into CMAQ were developed from the Integrated 

Planning Model (IPM). The IPM is a model of the U.S. electric power sector that 

can be used to evaluate the cost and emissions impacts of proposed policies to 

limit emissions of pollutants, including mercury. EPA has used the IPM in 

rulemakings since the mid 1990's. As part of that process, EPA takes comments 

on the underlying assumptions of the model and makes changes as a result. For 

its Clean Air Interstate Rule and CAMR analyses, EPA used IPM to estimate base 

case and future year national inventories of unit-specific mercury emissions under 

different control scenarios. 

IPM uses equations (emission modification factors) to estimate utility emissions 

given the chemical composition of the coal being burned as well as various 

operating characteristics of the utility unit (e.g., type of control technology 

installed). These equations were based on various coal composition and 

emissions testing data collected during a !999 Information Collection Request 

and more recent testing conducted by EPA, the Department of Energy, and 

industry participants. 

While extensive data have been collected on mercury emissions from coal-fired 

utilities, some data and science gaps still exist with respect to understanding the 

effectiveness of specific controls in reducing mercury emissions from coal. As 

noted in the EPA Office of Research and Development's February 18,2005, 

3 Mercury speciates into three basic forms: elemental, ionic, and particulate. Estimating the amount of speciated 

mercury emissions is important since the type of mercury emitted impacts how effectively it is captured by control 

technologies, and how it will react when emitted into the atmosphere. Differences in atmospheric reactions impact 

the amount and location of the mercury's deposition. 

8 
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27172.750

update of its study on control of mercury emissions, data and science gaps exist 

with respect to existing controls that are intended to reduce emissions of other 

pollutants with the co-benefit of reducing mercury, as well as emerging 

technologies specifically designed to reduce mercury emissions. The impact of 

these uncertainties on EPA's estimates of mercury emissions in base case and 

future years is qualitatively discussed in Agency documents but has not been 

quantified. The uncertainties could impact the accuracy of the estimated utility 

emissions input into CMAQ and CMAQ's resulting deposition estimates. 

CMAQ Model Uncertainties and Limitations 

CMAQ is useful for predicting regional and national patterns of deposition, but it 

has limitations that need to be carefully considered when used for modeling small 

areas of localized deposition and, thus, identifying hotspots. When emissions data 

are fed into CMAQ, the model averages the data over an area known as a "grid 

cell." CMAQ can predict deposition results over grid cells of various sizes (or 

resolutions) as specified by the modeler. 

For CMAQ, EPA used a 36 kilometer (km) grid resolution (36 km x 36 km) for 

its Clean Air Interstate Rule and CAMR modeling, which equates to a surface 

area approximately 22 miles wide by 22 miles long, or approximately 484 square 

miles. The model provides one average concentration for the entire area. For 

example, if there is only one power plant in the corner of a grid square, that 

plant's emissions are averaged over the entire 36 km x 36 km area. Averaging 

over grid cells may result in a smoothing out of areas of high and low deposition. 

EPA acknowledges this limitation in its Effectiveness Technical Support 

Document: 4 

CMAQ immediately diluteb'} simulated emissions into the entire grid 

volume in which they are released. This causes an artificially fast dilution 

and under-represents direct deposition from air to surfaces near emission 

sources .. . 

When looking for hotspots, the ability to identify areas of localized deposition is 

important. Using the CMAQ model at 36 km x 36 km, in the opinion of some 

EPA officials we interviewed, was too coarse a resolution to be able to pinpoint 

small areas of localized deposition. Some EPA officials stated that use of a finer 

resolution, such as 12 km grid size, is possible in CMAQ. However, at very fine 

resolutions- for instance, a 4 km grid size- the meteorological components of 

the model probably fall apart and may introduce greater uncertainties in model 

results. EPA outlines three reasons for using a 36 km grid square size in its 

Effectiveness Technical Support Document. First, the larger grid size would 

account for mercury deposition that enters a watershed through groundwater 

4 Methodology to Generate Deposition. Fish Tissue Methylmercury Concentralions, and Exposures for Determining 

Effectiveness of Utility Emission Controls (Effectiveness Technical Support Document). U.S. EPA, March 15,2005. 

9 
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inflow and runoff, as opposed to a smaller grid size that may only account for 

direct inputs to surface water. Second, in larger waterbodies where there is 

substantial fishing activity, the fish species consumed by humans are likely 

migratory and the accumulation of mercury in these fish will come from 

deposition over a larger area. Third, many anglers may catch fish from a variety 

of waterbodies in a watershed, thus a larger grid size would account for this 

fishing pattern. 

Study Finds Different Rates of Atmospheric Chemical Reactions 

The Mechanisms of Mercury Removal Study developed information on the rates 

of atmospheric chemical reactions involving mercury that is different than rates 

used by EPA in its CAMR hotspots analysis. The study was published in June 

2005 after EPA issued CAMR. Rate constants, which quantify the speed or rate 

of chemical reactions, are the most important inputs affecting modeling results. 

The accuracy of rate constants can affect the accuracy of modeling results. 

Oxidation is an atmospheric process that makes mercury more reactive and is the 

most important reaction associated with mercury deposition. The mercury 

oxidation rate affects how quickly mercury is deposited and influences its 

properties and behavior. For example, oxidation makes elemental mercury more 

water soluble and more quickly deposited; if mercury emitted from a source 

comes out already oxidized, it can be immediately deposited near the source 

(depending on meteorological conditions and other factors). 

Results of the Mechanisms of Mercury Removal Study regarding mercury 

reactions and associated rates suggest that emissions from global sources 

potentially account for less mercury deposition in the United States than 

previously believed. This means that the contribution of global sources to U.S. 

deposition may have been overestimated in EPA's analysis and the impact from 

domestic sources underestimated. According to the Agency scientist responsible 

for developing mercury capabilities in CMAQ, if the study's results about rate 

constants are accurate, then chemical formulations currently used in all other 

atmospheric simulation models, including CMAQ, could be incorrect (when 

modeling mercury deposition). 

Uncertainties Noted with Methylation and Bioaccumulation 

Assumptions about methylation and bioaccumulation directly impact the resulting 

predictions about mercury fish tissue concentrations after implementation of 

CAMR. Mercury methylation is a complex process that occurs in the 

environment when oxidized mercury is transformed into highly toxic 

methylmercury, which bioaccumulates (builds up) in fish tissue. Some of the 

important factors affecting methylation rates and bioaccumulation were not fully 

accounted for in EPA's analysis. Also, a lack of knowledge about some factors 

used in EPA's analysis is a source of uncertainty in EPA's conclusions about 

mercury fish tissue concentrations. 

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Methylation. Transformation of mercury to methylmercury occurs at varying 

speeds in different waterbodies, and EPA's analysis did not fully account for this 

variation. Methylation occurs when mercury enters waterbodies and bacteria 

transform it to methylmercury, a highly toxic and bioaccumulative form of 

mercury. Methylation of mercury occurs in waterbodies at highly variable speeds 

depending on various ecosystem-specific factors, including: the bacteria in the 

waterbody, the type of land surrounding the waterbody, the quantity of certain 

substances such as sulfate and carbon in the waterbody, and the pH (chemistry) of 

the waterbody. Thus, two adjacent waterbodies with equal mercury deposition 

can have different concentrations of mercury in fish. 

EPA's analysis did not address individual differences between waterbodies, or the 

time it takes for different waterbodies to adjust to changes in atmospheric 

deposition. The modeling assumed that the environmental factors affecting the 

formation of methylmercury remain constant. EPA acknowledges that a lack of 

knowledge about methylation is "a major contributor to overall uncertainty" in its 

analysis; however, the effect of this uncertainty on the Agency's ability to inform 

mercury control policies is highly variable. An EPA official stated that variance 

in methylation rates was taken into account because actual methylmercury fish 

tissue measurements, which reflect varying methylation rates among different 

waterbodies where measurements were obtained, were used in the "utilityattributable" hotspot analysis. As explained in the next section, we found that 

concerns remain about these fish tissue measurements, which call into question 

how well they address methylation uncertainties. 

Bioaccumulation. EPA's analysis did not fully account for the highly variable 

ways that mercury bioaccumulates in fish. When mercury deposition to a 

waterbody changes because of reductions in emissions, it can take time for those 

changes to be reflected in fish tissue methylmercury concentrations. Fish absorb 

methylmercury from their food and directly from water as it passes over their 

gills. To predict levels of methylmercury in fish tissue, CMAQ deposition results 

for a given area were input into a model that assumed a proportional relationship 

between declines in atmospheric mercury deposition and declines in mercury fish 

tissue concentrations. For example, a 50-percent decrease in mercury deposition 

rates was projected to lead to a 50-percent decrease in mercury concentrations in 

fish. However, drawing conclusions and making comparisons between different 

fish types is limited in that mercury bioaccumulates in highly variable ways 

among fish, both between species and within individual fish of a species. To 

establish a 2001 baseline estimate of methylmercury fish tissue concentrations, 

EPA used data from the National Listing ofFish Advisories and the National 

Lake Fish Tissue Survey: 

For included locations, samples for the same species are averaged across all 

available years (post 1998), and then the highest averaged per species 

concentration is used to represent the methylmercury concentration/or that 

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sample location. For example, if there are two species at a location, walleye 

and pike, with three sampling dates for each species, we would first average 

over the three sample dates for each species, and then select walleye if the 

average for walleye is highest, or select pike if the average for pike is highest . 

. . . Assignment of the maximum average species concentration recognizes the 

greater risk to an individual consuming species with higher accumulation of 

mercury while respecting the .fact that each sample for an individual species is 

only an estimate of the true mean concentration in that species. 

According to EPA staff, the adequacy of current fish tissue data is sparse- it is 

patchy, non-standardized from State to State, and only identifies potential 

problems where data were actually collected. Regarding EPA's fish tissue data, 

an Agency official said, "The data does not support the conclusion that CAMR 

will not cause hotspots." In its Effectiveness Technical Support Document, EPA 

states that, among other limitations, the model it used to estimate changes in 

methylmercury fish tissue concentrations does not account for the time lag 

between a reduction in mercury deposition and a reduction in methylmercury 

concentrations in fish tissue. However, the document stated that EPA is unaware 

of any other tool for performing a national-scale assessment of the change in fish 

methylmercury concentrations resulting from reductions in atmospheric 

deposition of mercury. 

Study Shows Significant Deposition from Local Sources 

Results from the Steubenville Study,5 a multiyear study in the Ohio River Valley, 

found that approximately 70 percent of mercury wet deposition at Steubenville, 

Ohio in 2003 and 2004 was attributable to local/regional coal combustion sources, 

predominantly from utility boilers.6 The results ofthe Steubenville Study suggest 

that additional monitoring is necessary to ensure that EPA's CAMR analysis has 

properly estimated the contribution of local and regional mercury deposition. 

For example, while CMAQ results do not provide an estimate of mercury wet 

deposition for Steubenville specifically (due to its 36 km x 36 km grid cell area), 

it estimated for 2001 that 44 percent of the wet deposition in the grid cell 

containing Steubenville was from coal-fired utilities. Spatial and temporal 

differences7 between the Steubenville Study and EPA's CAMR analysis do not 

allow for their results to be fully comparable; however, data from other 

monitoring sites further suggest that monitoring is needed to ensure that CMAQ 

5 A peer review of the Steubenville Study was completed in late December 2005 and it was submitted for 

publication in a scientific journal in February 2006. 6 The Steubenville Study results have an uncertainty bound of approximately 15 percent. This uncertainty bound 

does not follow a normal distribution pattern but is positively skewed, i.e., the upper bound of the 95 percent 

confidence interval extends further from the estimate than the lower bound. 7 The Steubenville Study wet deposition results are for 2003 and 2004 and (1) represent the wet deposition for a 

specific monitoring location; (2) include wet deposition for all coal-combustion sources; and (3) have quantified 

estimates of uncertainty. Conversely, the CMAQ results are for the year 2001 and (I) represent an estimate for a 

much larger area (i.e., a 36 km x 36 km grid cell); (2) represent deposition from coal-fired utilities only; and (3) do 

not quantify uncertainty. 

12 
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has not underestimated wet deposition in some locations. An Agency scientist 

noted that: 

.. . CMAQ runs conducted using 2001 emissions data.for CAMR modeling 

showed that there are areas in the US. where domestic sources create large 

areas of enhanced deposition (e.g., up to 60% of wet mercwy deposition in 

some areas originatedfrom domestic coal combustion sources). The 

Steubenville measurements are consistent with these projections. As an 

example of uncertainties related to CMAQ ... the University of Michigan has 

run a nehi!ork of event-based mercury monitoring sites in the Midwest and 

Vermont and the 2001 CMAQ model runs systematically underestimate the 

deposition observed at these sites (in some cases by over afactor of 2). 

Senior Office of Air and Radiation officials told us that the Steubenville area is 

known to have higher-than-average deposition from coal-fired utilities, and that 

the preliminary monitoring results were not unexpected. OAQPS noted that for 

grid cells neighboring the Steubenville grid cell, the CMAQ model predicted that 

a higher percentage of mercury deposition was attributable to utility coal 

combustion (i.e., 57 to 71 percent). Preliminary results of the Steubenville Study 

were made available to Agency officials shortly after EPA's promulgation of 

CAMR and the Revision of December 2000 Regulatory Finding in March 2005, 

but were not available for consideration by the Agency during its promulgation of 

these rules. The Agency noted that they analyzed a number of scientific studies in 

developing CMAQ, but our evaluation did not consider all of the scientific 

evidence EPA used in developing CMAQ. As noted in Appendix A, we did not 

evaluate all the inputs and assumptions associated with EPA's mercury hotspots 

analysis. Additional limitations of our evaluation are listed in Appendix A. 

Uncertainties Underscore Need for Mercury Monitoring Plan 

In the preamble to the Revision of December 2000 Regulatory Finding, EPA 

stated that although it believed the likelihood of a "utility-attributable" hotspot 

occurring to be "remote," it intended to closely monitor the potential for hotspots, 

continue to advance the state ofthe science of mercury fate and transport, and 

take appropriate action if the possibility of a "utility-attributable" hotspot arose 

after implementation ofCAMR. However, at the time we completed our field 

work, EPA had not yet developed a plan for monitoring hotspots. Given the 

uncertainties associated with the inputs to the CMAQ model and the results of 

recent studies as noted, it is important for EPA to have a plan to monitor mercury 

deposition. Mercury monitoring data could assist the Agency in determining 

"utility-attributable" hotspots, and in evaluating and improving the accuracy of its 

mercury fate and transport models. Without a mercury monitoring plan, "utilityattributable" hotspots could potentially occur after implementation of CAMR but 

be less likely to be identified due to a lack of deposition data or reliable modeling 

techniques to identify mercury sources. 

13 
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27172.755

Field measurement of mercury deposition could improve EPA's ability to conduct 

source apportionment studies to help to determine whether a hotspot was "utilityattributable." To assess whether CAMR results in "utility-attributable" hotspots, 

EPA must have mercury deposition data that enable it to identity the mercury 

source. Source-apportionment studies, such as that conducted by EPA in 

Steubenville, are designed to accomplish this task. Such studies estimate a 

source's contribution to mercury deposition and require the collection of 

deposition samples and measurements of trace elements in addition to mercury. 

Trace elements are elements that are co-emitted with mercury from particular 

sources, and help identity from which source(s) the deposited mercury originally 

came. For example, sulfur and selenium are trace elements associated with coal 

combustion. When these elements are in samples of deposited mercury, they 

indicate the mercury came from coal combustion sources. By employing a 

monitoring plan that incorporates more studies of this nature, EPA can better 

assess the impact that utilities have on mercury deposition and resulting fish tissue 

concentrations. 

Mercury deposition data would also help EPA improve its current understanding 

of mercury fate and transport, and allow the Agency to validate and improve 

mercury deposition estimation models and techniques. Model performance can 

be assessed by comparing model predictions to actual field data. While mercury 

deposition data are available through the Mercury Deposition Network (MDN), 

these data have important limitations for model evaluation, particularly modeling 

designed to identity mercury hotspots: 

• The MDN measures only wet deposition because there is no adequate field 

methodology currently available for dry deposition. 

• The MDN does not generally provide deposition monitoring data for areas 

expected to be of greatest concern for deposition from local emissions 

sources. This is because MDN monitoring sites are generally located in 

rural locations that do not have local sources of emissions. 

• There are large areas ofthe nation with few or no MDN monitoring sites. 

• The MDN collects deposition samples on a weekly basis, so it does not 

accurately measure the impacts of individual events, such as rain or 

snowfall. 

• The MDN sites do not collect trace element data, such as sulfur and 

selenium data for coal combustion, which is needed to conduct source 

apportionment modeling. 

Due to the limitations associated with available data from the current mercury 

deposition monitoring network, EPA is currently unable to fully assess the 

accuracy ofCMAQ's mercury deposition predictions against actual field 

14 
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27172.756

measurements. Agency officials told us that the EPA Office of Research and 

Development's National Exposure Research Laboratory was already 

implementing a research plan for mercury monitoring, but recent budget 

reductions have halted the program. 

Conclusion 

EPA has acknowledged uncertainties and limitations in its analysis of the 

potential for "utility-attributable" hotspots. The results from two studies- the 

Mechanisms of Mercury Removal Study and the Steubenville Study- illustrate 

uncertainties about some of the key assumptions used in CMAQ and the 

deposition results projected by the model. Further consideration of uncertainties 

could alter EPA's conclusions about the potential for "utility-attributable" 

mercury hotspots. EPA indicated it will closely monitor hotspots, continue to 

advance mercury science, and take appropriate actions if hotspots arose. To 

accomplish this, the Agency needs to establish a monitoring plan to conduct 

source-apportionment studies to measure the impact of CAMR and to assist in 

evaluating the accuracy of its model predictions against actual field data. 

Recommendation 

We recommend that the Acting Assistant Administrator for Air and Radiation: 

2-1 Work with the Assistant Administrator for the Office of Research and 

Development to develop and implement a mercury monitoring plan, 

including milestones and responsible program offices for implementing 

each component of the plan, to: (I) assess the impact of CAMR, if 

adopted, on mercury deposition and fish tissue; and (2) evaluate and 

refine, as necessary, mercury estimation tools and models. This effort 

should consider the suitability of the Office of Research and 

Development's mercury research plan for addressing these objectives. 

Agency Comments and OIG Evaluation 

The Agency generally agreed with the recommendation in Chapter 2 of the report. 

However, the Agency expressed concern with our characterization of some 

scientific issues in the report and offered clarification on three specific issues. We 

accepted the Agency's technical clarifications and have made changes to the final 

report as appropriate. The Agency also provided us with additional concerns not 

specifically addressed in its written response to our draft report. We met with the 

Agency to discuss these concerns, and made changes to the final report as 

appropriate. In response to our recommendation, the Agency stated that the 

Office of Air and Radiation and Office of Research and Development will 

continue to work together to ensure that they are using the best possible 

information to assess the transport, transformation, deposition, and fate of 

mercury emissions in the United States. We support the Agency's commitment to 

15 
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27172.757

using the best possible information to assess the impact of mercury emissions in 

the United States, and continue to recommend the Agency develop a monitoring 

plan to better ensure that this happens. The Agency's formal written response is 

in Appendix C. 

16 
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27172.758

EPA does not clearly explain how the "'utility-attributable" hotspot definition 

affects the Agency's ability to revise performance standards under CAMR. When 

CAMR is read in conjunction with the Revision of December 2000 Regulatory 

Finding, we believe the CAMR could be interpreted to preclude EPA from taking 

action to mitigate a mercury hotspot (such as tightening the cap or utilities' 

performance standards) unless it first determined that the hotspot was solely 

"utility-attributable." If this were the case, such a prerequisite could limit EPA's 

ability to reduce methylmercury fish tissue concentrations below acceptable 

levels, and thus address public health hazards that are being caused predominantly 

(but not "solely") by utilities. This could also impact EPA's ability to reduce the 

number of waterbodies with fish consumption advisories. 

EPA Provides "Utility-Attributable" Hotspot Definition 

In its Revision of December 2000 Regulatory Finding, EPA defined a "utilityattributable" hotspot8 as: 

" ... a waterbody that is a source of consumable fish with Methylmercury 

tissue concentrations, attributable solely to utilities, greater than the 

EPA 's Methylmercury water quality criterion of 0.3 mglkg. " 

This definition only considers the contribution of one source (utilities) on 

environmental problems that could threaten human health, and would only 

consider a hotspot to be "utility-attributable" if the utility emissions alone caused 

methylmercury in fish tissue to exceed 0.3 mg/kg. 

According to the preamble of the Revision of December 2000 Regulatory Finding, 

EPA adopted this definition based on its interpretation of Clean Air Act Section 

ll2(n), which directed the Agency to" ... study hazards to public health 

reasonably anticipated to occur as a result of emissions by electric utility steam 

generating units." EPA interpreted the language "as a result of' to mean that 

utility emissions must be the sole cause of a health hazard, and not just contribute 

to causing a hazard, to be regulated under Section 112. Using EPA's 

methylmercury water quality criterion of 0.3 mg/kg in fish tissue as the one 

8 EPA uses the tenns "hotspot," "hot spot," "utility hot spot," and "utility-attributable hotspot" interchangeably 

throughout the Revision of December 2000 Regulatory Finding when referring to a waterbody that is a source of 

consumable fish with methylmercury tissue concentrations, attributable solely to utilities, greater than the EPA's 

methylmercury water quality criterion of0.3 mglkg. 

17 
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27172.759

measure for "hazards to public health," EPA adopted the "utility-attributable" 

hotspots definition to determine whether such utility hotspots would remain after 

implementation ofthe Clean Air Interstate Rule and CAMR. Based on the 

analysis described in Chapter 2 of this report, EPA stated that it did not believe 

that "utility-attributable" mercury hotspots would exist after implementing these 

rules, therefore supporting the Agency's decision that utilities did not need to be 

regulated under Section 112 of the Clean Air Act. 

"Utility-Attributable" Definition Could be Interpreted to Limit 

EPA's Ability to Mitigate Hotspots 

The "utility-attributable" definition could be interpreted to limit EPA's ability to 

address waterbodies with elevated levels of mercury unless utility emissions were 

the sole cause of the problem. This could in turn limit EPA's ability to reduce the 

number of waterbodies with fish consumption advisories where there is a health 

risk due to the combined impact of mercury from all sources, including air 

emissions. 

As discussed in its December I 997 Mercury Study Report to Congress, EPA 

stated that there is "clearly" a need to address the combined impacts of mercury 

originating from all sources, including air emissions, wherever the combination of 

sources have been related to unacceptably high mercury levels in fish. Further, in 

its December 2000 Finding, EPA recognized concerns about the potential local 

impact of mercury trading programs and acknowledged that: 

. . . approaches that involve economic incentives must be constructed in a 

way that assures that communities near the sources of emissions are 

adequately protected 

Within CAMR and the Revision of December 2000 Regulatory Finding, EPA 

specifies several actions it might take to mitigate the effects of a hotspot in the 

event one should be identified. However, our analysis of the revision and CAMR 

suggests that the Agency may be precluded from taking any of those actions 

unless the hotspot first meets the criteria of a "utility-attributable" hotspot. EPA 

officials told us that this was not the intent ofthe rule, but agreed that the rule 

could be clearer. 

CAMR and Revision Must be Read Together 

Based on our reading ofCAMR and the Revision of December 2000 Regulatory 

Finding, we conclude that the definition of a hotspot presented in the revision is 

intended to apply to CAMR. CAMR and the revision were issued on the same 

day and address the same subject matter. In addition, the preamble to the CAMR 

restates EPA's conclusion from the revision, but refers to it as part of"this 

action": 

18 
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27172.760

As stated elsewhere in this action EPA does not believe that utilityattributable hot spots will be an issue after implementation ofCAJR 

[Clean Air Interstate Rule] and CAMR. 

Because "utility-attributable" hotspots are not discussed "elsewhere" within 

CAMR, we conclude that "this action" refers to the other, closely related action 

published by EPA on the same day. This action, the Revision of December 2000 

Regulatory Finding, defines "utility-attributable" hotspots and also explains that 

EPA may address hotspots under "other authorities under the CAA [Clean Air 

Act]," should they occur. However, the only mechanism to which EPA refers in 

order to addresses potential future hotspots- and the only mechanism presently 

promulgated- is CAMR. The revision cites the following ways it could address 

"utility-attributable'' hotspots: 

... if in the future we determine that utility-attributable hotspots exist and 

that those hotspots occur as the result of Hg emissions from coal-fired 

Utility Units, we may promulgate a tighter section Ill standard of 

pe~formance, provided we determine the technology can achieve the 

contemplated reductions. We could revise the standard of performance by 

adjusting the cap-and-trade program to limit trading by high-emitting 

Utility Units. . . . Thus, although we cannot conclude today which 

statutory authority we would implement to address utility attributable 

hotspots because that determination necessarily hinges on the facts 

associated with the identified hotspots, we do concfude that were such a 

situation to occur, we believe that EPA has adequate authority to address 

any such situation that may arise in the future. 

When read together, these regulatory actions suggest that a finding of a solely 

"utility-attributable" mercury hotspot is necessary to initiate Agency action to 

mitigate hotspots under CAMR. If this were the case, EPA would be precluded 

from requiring additional mercury reductions from the utility industry, even if it 

were determined that utilities were significantly contributing to a hotspot, if the 

utilities were not the sole cause of the hotspot. For example, if methylmercury 

fish tissue concentrations for a waterbody were at 0.32 mglkg, EPA's water 

quality criterion of0.3 mg/kg would be exceeded. If, in this hypothetical case, 

utility mercury emissions were causing 0.3 mg/kg or less of the total 

methylmercury, under the requirement as written, utilities would be excluded 

from any additional reductions to help mitigate the problem. 

We discussed our interpretation with Office of Air and Radiation officials. These 

officials confirmed that the "utility-attributable" hotspot definition in the revision 

applies to the CAMR. However, these officials told us that this definition does 

not establish a criterion for when the Agency can adjust the performance 

standards under CAMR. They noted that under Section Ill, performance 

standards are to be reviewed every 8 years, and can be adjusted for various 

reasons. 

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Conclusion 

The two rules related to controlling mercury emissions from coal-fired utilities 

were issued on the same day and refer to and are consistent with each other. 

Thus, it appears that they are intended to be read together. Further, the "utilityattributable" definition in the Revision of December 2000 Regulatory Finding 

applies to the discussion of hotspots in CAMR, and this definition establishes a 

criterion for when the CAMR can be adjusted to address a potential health hazard. 

If this were the case, tighter performance standards for utilities contributing to a 

hotspot could not be promulgated unless it was first determined that the hotspot 

was solely "utility-attributable." Although not the intent of the rulemaking, EPA 

officials agreed that the rule could be clearer. We believe CAMR, if adopted, 

should be clarified to avoid any possible misinterpretation of how the "utilityattributable" definition affects EPA's ability to modifY utility performance 

standards. 

Recommendation 

If EPA decides to adopt CAMR after the rule reconsideration process, to better 

ensure protection of public health and the environment, we recommend that the 

Acting Assistant Administrator for Air and Radiation: 

3-1 Explain in CAMR that the "utility-attributable" hotspot definition found in 

the revision does not establish a prerequisite for making future changes to 

the performance standards under CAMR. 

Agency Comments and OIG Evaluation 

The Agency's response did not specifically address our analysis and conclusion 

that CAMR could be interpreted to use the "utility-attributable" hotspot definition 

as a prerequisite for future changes to CAMR. The Agency commented that, 

while information regarding "utility-attributable" hotspots would be relevant to 

future possible revisions to CAMR, such hotspots are not a prerequisite to the 

Agency making changes to performance standards under CAMR. We believe the 

Agency's intent should be made clear in the final rule. Accordingly, we revised 

our final report to recommend that EPA, to better ensure protection of public 

health and the environment, explain in the CAMR that the "utility-attributable" 

hotspot definition set forth in the revision is not a prerequisite for making changes 

to the CAMR. After submitting its formal written response to the draft report the 

Agency also suggested clarifYing language to parts of Chapter 3. We accepted 

some of the suggestions and incorporated them into the final report. The 

Agency's formal written response is in Appendix C. 

20 
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Appendix A 

Details on Scope and Methodology 

We conducted interviews with staff from the following EPA offices: 

• Office of Air and Radiation, including its Office of Air Quality Planning and Standards 

and Office of Atmospheric Programs. 

• Office of Research and Development, including its National Exposure Research 

Laboratory and National Center for Environmental Research. 

• Office of Policy, Economics, and Innovation. 

• Office of Water. 

We also interviewed officials from the following external organizations: the National Oceanic 

and Atmospheric Administration, including its Air Research Laboratory; the Northeast States for 

Coordinated Air Use Management; and the Clean Air Task Force. 

To understand the variables associated with mercury fate and transport modeling and, 

specifically, CMAQ, we reviewed and/or discussed with the above officials selected reports and 

studies, including: 

• Mechanisms of Mercury Removal by 0 3 and OH in the Atmosphere. Calvert Jack G.; 

Lindberg Steve E. Atmospheric Environment, Volume: 39, Number: 18, Page: 3355-

3367, June 5, 2005. 

• The National Oceanic and Atmospheric Administration's September 2005 (draft) report 

by Cohen, et al, Report to Congress: Mercury Contamination in the Great Lakes. 

• EPA's Regulatory Impact Analysis of the Final Clean Air Mercury Rule, March 2005. 

• EPA's Mercury Study Report to Congress, December 1997. 

• A slide presentation on EPA's Steubenville, Ohio, study, Preliminary Results from 

Steubenville Hg Deposition Source Apportionment Study, Apri127, 2005. 

• The most recent peer review ofCMAQ, Final Report: Second Review of the CMAQ 

Model. 

• Technical Support Document: Methodology Used to Generate Deposition, Fish Tissue 

Methylmercury Concentrations, and Exposure for Determining Effectiveness of Utility 

Emission Controls. Analysis of Mercury from Electricity Generating Units, March 17, 

2005 (revised). 

• Technical Support Document for the Final Clean Air Mercury Rule: Air Quality 

Modeling, March 2005. 

• Emissions Inventory and Emissions Processing for the Clean Air Mercury Rule, March 

2005. 

21 
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27172.763

To gain an understanding of State and environmental groups' concerns related to EPA's analysis of 

potential "utility-attributable" hotspots under CAMR, we reviewed the following selected comments: 

The December 19, 2005 comments submitted In Reconsideration of Revision of 

December 2000 Regulatory Finding on the Emissions of Hazardous Air Pollutants From 

Electric Utility Steam Generating Units and the Removal a,{ Coal- and Oil-Fired Electric 

Utility Steam Generating Units from the Section II2(c) List 70 Fed Reg. 62200 (Oct. 

28, 2005); and Standards of Performance for New and Existing Stationary Sources: 

Electric Utility Steam Generating Units 70 Fed Reg. 622I3 (Oct. 28, 2005). Comments 

Submitted by: The States of New Jersey, California, Connecticut, Delaware, Illinois, 

Maine, Massachusetts. Minnesota, New Hampshire, New Mexico, New York, 

Pennsylvania, Rhode hland, Vermont, and Wisconsin, Docket No. OAR-2002-0056. 

The December 19, 2005 comments submitted regarding the "Revision of December 2000 

Regulatory Finding on the Emissions o.f Hazardous Air Pollutants From Electric Utility 

Steam Generating Units and the Removal of Coal- and Oil-Fired Electric Utility Steam 

Generating Units From the Section II2(c) List: Reconsideration," 70 Fed Reg. 62,200 

(October 28, 2005). Comments of Clean Air Task Force, Izaak Walton League of 

America, Natural Resources Council of Maine, Ohio Environmental Council, US. Public 

Interest Research Group, Natural Resources D~fonse Council, Chesapeake Bay 

Foundation, Waterkeeper, Aroostook Band of Micmac Indians, Houlton Band of Maliseet 

Indians, Penobscot Indian Nation, The Passamaquoddy Tribe at Indian Township. 

To gain an understanding ofEPA's definition of"utility-attributable" hotspots and the basis for 

that definition, we reviewed the following regulatory actions: 

Regulatory Finding on the Emissions of Hazardous Air Pollutants From Electric Utility 

Steam Generating Units, December 20, 2000. 

Proposed National Emission Standards for Hazardous Air Pollutants; and, in the 

Alternative, Proposed Standards of Performance for New and Existing Stationary 

Sources: Electric Utility Stream Generating Units; Proposed Rule, January 30, 2004. 

Final Rule- Preamble -Standards of Performance for New and Existing Stationary 

Sources: Electric Utility Steam Generating Units, March 15, 2005. 

• Final Rule- Regulatory Text- Standards of Performance for New and Existing 

Starionary Sources: Electric Utility Steam Generating Units, March 15, 2005. 

Final Rule- Revision of December 2000 Regulatory Finding on the Emissions of 

Hazardous Air Pollutants from Electric Utility Steam Generating Units and the Removal 

of Coal- and Oil fired Electric Utility Steam Generating Units from the Section II2 (c) 

List, March 15, 2005. 

• Reconsideration: Revision of December 2000 Regulatory Finding on the Emissions of 

Hazardous Air Pollutants }rom Electric Urility Steam Generating Units and the Removal 

of Coal- and Oil fired Electric Utility Steam Generating Units from the Section II2 (c) 

List, October 21, 2005. 

Reconsideration: Standards of Performance for New and Existing Stationary Sources: 

Electric Utility Steam Generating Units, October 21, 2005. 

22 
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27172.764

Prior Coverage 

In a prior EPA OIG report, Additional Analyses of Mercury Emissions Needed Before EPA 

Finalizes Rules for Coal-Fired Electric Utilities (2005-P-00003), dated February 3, 2005, we 

cited concerns about EPA's limited assessment of the potential for mercury hotspots resulting 

from its (then proposed) cap-and-trade program under CAMR. In that report, we recommended 

that EPA further assess the risk of hotspots and, if necessary, identifY how the Agency would 

reassess the hotspot issue. In response to our recommendation, EPA stated that it did not 

believe utility emissions would result in hotspots based on additional analyses it had performed, 

particularly after implementation of the Clean Air Interstate Rule and CAMR, but it would 

monitor the situation and take action if necessary. For this current review, we evaluated EPA's 

analysis of hotspots, its conclusion that there will be no "utility-attributable" hotspots after 

implementation of the Clean Air Interstate Rule and CAMR, and plans the Agency may have in 

place to continue to monitor the issue. Details on what we found, including recommendations, 

are in Chapters 2 and 3 of this current report. 

Internal Controls 

Government Auditing Standards require that auditors obtain an understanding of internal 

control significant to the audit objectives and consider whether specific internal control 

procedures have been properly designed and placed in operation. This evaluation was a 

limited-scope assessment of certain analyses pertaining to a rulemaking. Thus, we determined 

whether the Agency's hotspots analysis and conclusions were peer reviewed, and if the key 

model used in this analysis was separately peer reviewed. Peer review is a key internal control 

for ensuring the acceptability of scientific data and processes. We found that CMAQ, the main 

model used by EPA in its hotspots analysis, was peer reviewed; however, we found no evidence 

that the Agency's overall hotspots analysis, described in the document Methodology to 

Generate Deposition, Fish Tissue Methylmercury Concentrations, and Exposures for 

Determining Effectiveness of Utility Emission Controls, was peer reviewed. The Agency's 

Ecosystem Scale Modeling for Mercury Benefits Analysis, part of the Regulatory Impact 

Analysis for the CAMR, was peer reviewed. The benefits analysis was similar to the hotspots 

analysis, but it assessed the impact of CAMR on a national scale, as opposed to identifYing 

localized hotspots or local-scale impacts. 

Limitations 

Our work had several limitations. Specifically, we did not: 

• Review every model that contributed to EPA's analysis of the potential for "utilityattributable" hotspots under CAMR. 

Evaluate all of the inputs and assumptions associated with EPA's mercury hotspots 

analysis. 

• Evaluate the adequacy of EPA's water quality criterion to protect human health. 

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Appendix B 

Models Used in CAMR Analysis 

The following diagram depicts how data from each model were used in EPA's hotspot analysis. 

Details on each model follow the diagram. 

MM5 

t IPM ~ CMAQ ...., MMaps " Changes in methylmercury levels in fish tissue 

t GEOS-CHEM 

Mesoscale Model (MM5) 

Goddard Earth Observing 

System-CHEMistry 

(GEOS-CHEM) Global 

Model 

Community Multiscale Air 

Quality (CMAQ) Model 

Mercury Maps (MMaps) 

To analyze future cost and emissions 

impacts of proposed environmental 

regulations upon utilities. 

To provide meteorological information, 

such as wind, temperature, precipitation, 

and sea level pressure. 

To provide a global three-dimensional 

model of atmospheric chemistry driven by 

meteorology. 

To estimate mercury deposition. 

To simulate various chemical and physical 

processes thought to be important in the 

atmospheric transformation and distribution 

of mercury. 

To relate changes in mercury air deposition 

rates to changes in mercury fish tissue 

concentrations on a national scale. 

24 

Estimates mercury emissions 

from utilities after implementation 

of Clean Air Interstate Rule and 

CAMR. 

Simulates weather patterns, 

which affect where mercury 

deposits. 

Uses global chemistry and 

transport information to provide 

global/background mercury 

concentrations. 

Estimates amount of mercury 

deposition occuring within 36 km2 

grid cells after implementation of 

Clean Air Interstate Rule and 

CAMR. 

Uses CMAQ deposition data to 

estimate fish tissue 

concentrations of methylmercury 

based on the assumption of a 

1-to-1 ratio between reductions in 

air deposition and reductions in 

average methylmercury fish 

tissue concentrations. 
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Appendix C 

Agency Response to Draft Report 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

Bill Roderick, Acting Inspector General 

Office of the Inspector General 

Office of Program Evaluation 

130 I Constitution Ave. NW (2400 T) 

EPA West Building 

Washington, DC 20004 

Dear Mr. Roderick: 

Thank you for the opportunity to comment on the draft Office of the Inspector General 

(OIG) report entitled "Monitoring Needed to Assess Impact of EPA's Clean Air Mercury Rule 

on Potential Hotspots." In reviewing the draft report, we acknowledge your acceptance of the 

majority of the issues we identified in our earlier review. We have also recently supplied your 

office with additional written comments pertaining to the modeling analyses associated with the 

Steubenville project. We believe that the collective scientific and engineering expertise within 

EPA's Offices of Air and Radiation (OAR) and Research and Development (ORO) puts our 

offices in a unique position to assess the current state-of-the-science with respect to mercury 

transport, deposition, and fate, and its impact on the creation of utility-attributable hotspots. 

We continue to have concerns about the portrayal of some scientific issues in the report, 

and note three areas where we would like to provide clarifying remarks. First, with respect to the 

potential changes in the atmospheric reaction rates within the Community Multiscale Air Quality 

(CMAQ) model (see pages 9 and 10), such changes would be made uniformly in all mercury 

transport/deposition models, not just CMAQ. Thus, the enhancements would create different 

results in any assessment using these numerical simulation technologies. Second, regarding our 

need to improve ambient monitoring (see page \3), the report should acknowledge that the 

Mercury Deposition Network (MDN) currently measures only wet deposition because there is no 

adequate field methodology available for dry deposition. 

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Finally, in terms of how EPA addressed the uncertainties in methylation and 

bioaccumulation rates between different fresh water bodies, our supporting health benefits 

assessment materials describe in great detail our complete understanding of these processes. 

You are correct to point out, and we clearly acknowledge in our documents, the uncertainties 

associated with mercury transport, deposition, and effects. At the same time, it should be 

acknowledged that the magnitude of uncertainties and their effect on our ability to inform 

mercury control policies is highly variable. We believe we have clearly explained the science 

and the uncertainties and provided a solid foundation for the Clean Air Mercury Rule (CAMR). 

In your draft report, you recommend two specific follow-up actions for the Agency. 

Below we address each of these recommendations. 

Recommendation 2-1: Work with the Assistant Administrator for the Office of Research 

and Development to develop and implement a mercury 

monitoring plan, including milestones and responsible program 

offices for implementing each component of the plan, to: (1) 

assess the impact of CAMR, if adopted, on mercury deposition 

and fish tissue, and, (2) evaluate and refine, as necessary, 

mercury estimation tools and models. This effort should 

consider the suitability of the Office of Research and 

Development's mercury research plan for addressing these 

objectives. 

EPA currently operates the MDN, which is located predominantly in the eastern U.S. and 

monitors only wet deposition. In the technical support documents supporting CAMR, EPA 

has continually highlighted the need for and the willingness to support additional ambient 

monitoring, including the development of dry deposition monitoring, to enhance our ability to 

assess the numerical accuracy of our sophisticated simulation tools- e.g., the CMAQ model. 

As you are aware, ORD has been heavily involved over the past decade in developing the 

CMAQ model, and is actively engaged in utilizing ambient data and the latest scientific 

information to update the model to reflect the best possible chemistry and physics. OAR and 

ORO will continue to work together to ensure that we are using the best possible infonnation 

to assess the transport, transformation, deposition, and fate of mercury emissions in the U.S. 

Recommendation 3-1: If EPA decides to adopt CAMR after the rule reconsideration 

process, we recommend that the Acting Assistant Administrator 

for Air and Radiation: Specifically explain what role the "utilityattributable" hotspot definition has in determining whether to 

make any future changes to the performance standards under 

CAMR. 

EPA has explained to your staff that while information regarding utility-attributable 

hotspots would be relevant to future possible revisions to CAMR, such hotspots are not a 

prerequisite. CAMR controls are based on the new source performance standards (NSPS) as 

set forth in section Ill of the Clean Air Act. To this end, the Agency is required by law to 

review and revise, as necessary, these limits every eight years. In conducting such a review, 

26 
838 


27172.768

we will analyze and evaluate the availability of new mercury control technologies installed 

since the previous review, and to the extent they provide additional cost-efTective control, the 

Agency can move to change the existing NSPS limits. Additionally, the Agency continues to 

update its understanding of the science associated with mercury emissions, transport, 

transformation, and deposition, both from ambient data collection and monitoring and 

through continued enhancements to our analytical tool box. Thus, we feel that OAR and 

ORO are uniquely positioned to monitor this situation and provide the best possible solution 

for the protection of public health and the environment. 

In closing, we direct the OIG staff to the numerous technical documents supporting 

the final CAMR, particularly the benefits assessment materials in which we outline in detail 

the variability associated with methylation and bioaccumulation rates in different water 

bodies. In these documents, EPA has demonstrated that the conclusions reached in the 

CAMR are based firmly in sound scientific principles, utilizing the best information 

available. If your staff have additional questions in researching these documents, our 

scientists, engineers, and modelers would be happy to assist them. 

Sincerely, 

William Wehrum 

Acting Assistant Administrator 

Office of Air and Radiation 

George Gray 

Assistant Administrator 

Office of Research and Development 

27 
839 


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Distribution 

Office of the Administrator 

Acting Assistant Administrator for Air and Radiation 

Assistant Administrator for Research and Development 

Deputy Assistant Administrator for Air and Radiation 

Appendix D 

Acting Deputy Assistant Administrator for Science, Office of Research and Development 

Acting Deputy Assistant Administrator for Management, Office of Research and Development 

General Counsel 

Agency Followup Official (the CFO) 

Agency Followup Coordinator 

Audit Followup Coordinator, Office of Air and Radiation 

Audit Followup Coordinator, Office of Research and Development 

Associate Administrator for Congressional and Intergovernmental Relations 

Associate Administrator for Public Affairs 

Director, Office of Air Quality Planning and Standards 

Deputy Director, Office of Air Quality Planning and Standards 

Audit Liaison, Office of Air Quality Planning and Standards 

Acting Inspector General 

28 
840 


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GAO 

August 2003 

GA0-03-947 

United States General Accounting Office 

Report to Congressional Requesters 

CLEAN AIR ACT 

EPA Should Use 

Available Data to 

Monitor the Effects of 

Its Revisions to the 

New Source Review 

Program 

GAO 

Accountability "' Integrity * Reliability 
841 


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August 2003 

CLEAN AIR ACT 

EPA Should Use Available Data to 

Monitor the Effects of Its Revisions to the 

New Source Review Program 

What GAO Found 

Consistent with agency guidance, EPA used a limited screening analysis that 

relied on staff's professional judgment and public comments from earlier 

reform proposals to conclude that the final rule would decrease emissions 

and health risks and not impose significant costs. EPA determined that 

neither the rule's benefits nor its costs would exceed a $100 million 

threshold that triggers requirements to conduct a more comprehensive 

assessment. EPA Issued the rule to streamline the NSR permitting process 

and provide flexibility to industry. For example, the rule provides a 

mechanism for companies to develop plantwide emissions limits, which 

would allow them to make changes in one part of a facility's operations as 

long as they offset emissions increases with decreases eisewhere within the 

facility. While OMB agreed with EPA's conclusion that the rule would not 

have siguificant economic effects, it determined that the rule was significant 

for policy reasons. Therefore, OMB asked EPA if it could better quantify the 

rule's potential impacts, but the agency lacked the necessary data to do so. 

EPA lacked comprehensive data on the program's economic impacts, and 

could not predict how many facilities would use the rule's optional 

provisions. Several states and environmental groups disagree with EPA's 

conclusions1 claiming that it will enable facilities to increase their emissions. 

These parties have ffied suit against EPA challenging the rule and also have 

petitioned EPA to reconsider the rule. We did not identify any 

comprehensive assessments that contradicted or supported EPA's 

conclusions or the assertions of those who oppose the rule. Because of the 

data limitations, it was not possible to verify EPA's conclusions about the 

rule's effects. 

Because it lacked comprehensive data, EPA relied on anecdotes from the 

four industries it believes are most affected by NSR to conclude that the NSR 

program (prior to the rule) discouraged some energy efficiency projects, 

such as upgrades to industrial boilers, including some that would have 

decreased emissions. Because the information is anecdotal, EPA's findings 

do not necessarily represent the program's effects across the industries 

subject to the program. Several environmental groups disputed EPA's 

fmdings. One such group said that factors other than NSR, such as 

economic downturns, discouraged the projects. Furth.ennore, EPA's 

conclusion that some projects would have decreased emissions assumed 

that facilities would not increase production after performing the projects. 

However, according to EPA and the executive director of an industry group, 

companies often expand production after implementing energy efficiency 

projects because it is advantageous to maximize production at the most 

efficient facilities. Such expansions could increase emissions and related 

health risks, although EPA asserts that this would be offset by decreased 

production and emissions at less efficient facilities. 

----------------United States General Accounting Office 
842 


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Contents 

Letter 

Appendix I 

Appendix II 

Results in Brief 

Background 

EPA's Economic Analysis of the F1nal Rule Complied with EPA and 

OMB Cost-Benefit Analysis Requirements, but Some 

Stakeholders Have Sought to Ilave EPA Reconsider the Rule I 0 

EPA Relied Primarily on Anecdotes from Industries Most Affected 

by NSR to Conclude That it Discouraged Some Energy 

Efficiency Projects 16 

Conclusions 24 

Recommendations for Executive Action 25 

Agency Comments 25 

Objectives, Scope, and Methodology 

GAO Contacts and Staff Acknowledgments 

GAO Contacts 

Acknowledgments 

Table l: Chronology of the New Source Review Program 

Figure l: Percentage of Total U.S. Emissions Released by 

Industrial, Transportation, and Other Sources in 2001 

27 

29 

29 

29 

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GAO 

February 2005 

GA0-05-252 

United States Government Accountability Office 

Report to Congressional Requesters 

CLEAN AIR ACT 

Observations on EP.Ns 

Cost-Benefit Analysis 

of Its Mercury Control 

Options 

GAO 

Accountability * Integrity * Reliability 
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February 2005 

CLEAN AIR ACT 

Observations on EPA's Cost-Benefit 

Analysis of Its Mercury Control Options 

What GAO Found 

GAO identified four major shortcomings in the economic analysis underlying 

EPA's proposed mercury control options that limit its usefulness for 

informing decision makers about the economic trade-offs of the different 

policy options. First, while Office of Management and Budget (OMB) 

guidance directs agencies to identify a policy that produces the greatest net 

benefits, EPA's analysis is of limited use in doing so because the agency did 

not consistently analyze the options or provide an estimate of the total costs 

and benefits of eacll option. For example, as seen in the table, EPA analyzed 

the effects of the technology-based option by itself, but analyzed the effects 

of the cap~and-trade option alongside those of another proposed rule 

affecting power plants, the Clean Air Interstate Rule (the interstate rule), 

without separately identifying the effects of the cap-and-trade option. As a 

result, EPA's estimates are not comparable and are of limited use for 

assessing economic trade-offs. EPA officials said they analyzed the cap-andtrade option alongside the interstate rule because the agency views the two 

proposed rules as complementary. Nonetheless, to provide comparable 

estimates, EPA would have to analyze each option alone and in combination 

with the interstate rule. 

Estimated Annual Economic Impacts of EPA's Proposed Mercury Policy Options in 2010 

(1999 dollars, in billions) 

Annual net 

~P'-'o"'li'"cy,_,o,.p,.tio,n,_ __ -'A"-"nnual costs Annual beneftt=•-~"~•~••~f~lt•~---

" Techn_s~_!()_gy-basad op_~.<:!!!_g_ _____________ 1~ .. 2!.~9~"--1.3_ or mo_r~----

~=~~:~~~-:~:i~~tion _Not ~'"'''"-'im,at.,ed,__ __ _,N,ot ~stim.~•='•~d~-~N~o~t es=tim~a~te"'d __ 

and the interstate rule Not estimated Not estimated Not estimated Cap-and-trade option and 

the interntate rule 3 to 5 or more sa to 73 or more 55 to 68 or more 

Source: EPA. 

Second, EPA did not document some of its analysis or provide information 

on how changes in the proposed level of mercury control would affect the 

cost-and-benefit estimates for the technology-based option, as it did for the 

cap-and-trade option. Third, EPA did not estimate the value of the health 

benefits directly related to decreased mercury emissions and instead 

estimated only some secondary benefits, such as decreased exposure to 

harmful fine particles. However, EPA has asked for comments on a 

methodology to estimate the benefits directly related to mercury. Fourth, 

EPA did not analyze some of the key uncertainties underlying its cost-andbenefit estimates. 

--------------United States Government Accountability Office 
845 


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Contents 

Letter 

Appendixes 

Resull• in Brief 

Background 

EPA:s Economic Analysis Is of Limited Use for Informing Decision 

Makers about the Economic Trade-offs of Different Policy 

Options 

Conclusions 

Recommendations for Executive Action 

Agency Comments 

1 

3 

5 

8 

15 

16 

16 

Appendix 1: Objectives, Scope, and Methodology 20 

Appendix II: Comments from the Environmental Protection Agency 21 

Appendix III: GAO Contacts and Staff Acknowledgments 23 

GAO Contacts 23 

Staff Acknowledgments 23 

Table Table 1: Estintated Annual Economic Impacts of EPA:s Proposed 

Mercury Policy Options in 2010 9 

Abbreviations 

CAA 

EPA 

FDA 

!PM 

MACT 

OMB 

UMRA 

Clean Air Act 

Envirorunental Protection Agency 

Food and Drug Administration 

Integrated Planning Model 

Maximum Achievable Control Technology 

Office of Management and Budget 

Unfunded Mandates Reform Act 

This is a work of the U.S. government and is not subject to copyright protection in the 

United States. It may be reproduced and distributed in its entirety without further 

permission from GAO. However, because this work may contain copyrighted images or 

other material, permission from the copyright holder may be necessary if you wish to 

reproduce this material separately. 

Pagei GA0·05~2S2 Clean Air Act 
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GAO 

June 2006 

GA0-06-669 

United States Government Accountability Office 

Report to Congressional Requesters 

CLEAN AIR ACT 

EPA Should Improve 

the Management of Its 

Air Toxics Program 

GAO 

Accountability "' Integrity * Reliability 
847 


27172.777

June 2006 

CLEAN AIR ACT 

EPA Should Improve the Management of 

Its Air Toxics Program 

What GAO Found 

While EPA has made some progress in implementing its air taxies program 

mandated by the 1990 Clean Air Act Amendments, most of its regulatory 

actions were completed late and major aspects of the program have still not 

been addressed. Most of EPA's progress relates to issuing emissions 

standards for large stationary sources, although EPA completed these 

standards about 4 years behind schedule. However, many of the unrnet 

requirements pertain to limiting emissions from small stationary and mobile 

sources, which collectively acconnt for most emissions of air taxies. The 

agency faces continuing implementation challenges stenuning from the 

program's low priority relative to other programs and related funding 

constraints. To this end, the agency lacks a comprehensive strategy for 

completing the urunet requirements or estimates of resources necessary to 

do so. Senior EPA officials said the program's agenda is largely set by 

external stakeholders who file litigation when the agency misses deadlines. 

As a result of EPA's limited progress, the agency has not addressed health 

risks from air toxics to the extent or in the time frames envisioned in the 

Clean Air Act. Senior EPA officials said that issuing standards for large 

stationary sources had addressed the greatest risks from air taxies and that 

other clean air programs also control air taxies as a side benefit. However, 

EPA does not have reliable data on the degree of risk reduction achieved 

through its regulations. Furthermore, the data that are available suggest that 

the agency has substantial opportunities to reduce emissions from mobile 

and small stationary sources. 

Available information on EPA's efforts to control air taxies is not sufficiently 

comprehensive to measure the program's total costs and benefits. 

Specifically, EPA has not comprehensively estimated the national economic 

costs of all air taxies standards and lacks the data necessary to assess the 

benefits of these standards, such as decreased incidence of cancer. 

Information on these impacts would help the agency assess the overall net 

benefits (total benefits minus total costs) of the air taxies program and 

compare these effects with those generated by higher-priority clean air 

programs, such as those intended to address smog. Data on other indicators 

of the program's effectiveness, such as changes in emissions, concentrations 

of air taxies in the (ambient) outdoor air, and data on compliance with air 

taxies standards are also limited and inconclusive. 

The state and local programs we reviewed use practices that could 

potentially help EPA enhance the effectiveness of its air toxics program. For 

example, several state programs have systematic approaches for identifying 

and prioritizing new pollutants that could inform EPA's efforts to meet the 

act's requirement to review and update the list of regulated pollutants. 

--------------United States Government Accountability Office 
848 


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Contents 

Letter 

Results in Brief 4 

Background 8 

EPA Has Made Limited Progress in Addressing the Clean Air Act's 

Requirements for Air Toxics and Faces Significant 

Implementation Challenges 15 

Available Information on Costs and Benefits Is Not Sufficient to 

Measure the Program's Effectiveness 25 

State and Local Programs Employ Practices That Could Potentially 

Help EPA Enhance the Effectiveness of the Federal Air Toxics 

Program 33 

Conclusions 41 

Recommendations for Executive Action 42 

Agency Comments 43 

Appendix I Status of EPA's Efforts to Respond to 

Recommendations in the National Academies' 

Report on Air Quality 47 

Appendix II Objectives, Scope, and Methodology 48 

Appendix III Prof"Il.es of State and Local Air Toxics Programs 52 

California 53 

New Jersey 53 

Oregon 54 

Wisconsin 54 

Louisville, Kentucky 55 

Appendix IV Comments from the Environmental Protection 

Agency 56 

GAO comments 63 

AppendixV GAO Contact and Staff Acknowledgments 65 

Pagei GA0-06-669 Cle81l Air Act 
849 


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Tables 

Table 1: The Five Most Commonly Emitted Air Toxics, 2002 10 

Table 2: Overview of the Risk Assessment Process 12 

Table 3: Number of Air Toxics Actions Required under the 1990 

Clean Air Act Amendments 14 

Table 4: EPA Progress in Meeting Air Toxics Requirements 16 

Table 5: Timeliness of MACT Emission Control Standards for Major 

Source Categories 17 

Table 6: EPA Funding for Air Toxics Program as a Percentage of 

Funding for All Clean Air Programs, Fiscal Years 2000 

through 2005 20 

Table 7: Percentage of Estimated Total Air Toxics Emissions by 

Source Type, 1993, 1999, and 2002 22 

Table 8: Issues Rated by Stakeholders as Challenges to a Large or 

Great Extent 24 

Table 9: Summary of Annual Costs Imposed by the 1990 Clean Air 

Act Amendmenl• 26 

Table 10: Key Steps in Estimating the Benefits of Controlling Air 

Toxics 28 

Table II: Results of Inspections at Facilities Regulated by Air 

Toxics Standards, 2003 and 2004 33 

Table 12: Selected State and Local Air Toxics Programs 52 

Figure 1: Conunon Sources of Air Toxics Emissions 

Figure 2: EPA Air Toxics Regulatory Framework for Major 

Stationary Sources 13 

Figure 3: Emission Points at an Industrial Facility Emitting Air 

Toxics 38 

Pagell GA0-06-669 Clean Air Act 
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27172.780

October 3, 20 17 

Dear Senator: 

On behalf of our millions of members, Earthjustice, the League of Conservation Voters, the 

Natural Resources Defense Council and the Sierra Club oppose the nomination of William 

Wehrum to be the Assistant Administrator for the Office of Air & Radiation for the United States 

Environmental Protection Agency. We are national nonprofit organizations dedicated to 

improving the quality of the human environment, protecting public health and safeguarding the 

nation's natural resources. 

Mr. Wehrum has a long record of working to weaken public health and clean air protections for 

Americans. While he served in senior leadership positions with the EPA air program, courts held 

the agency in violation of the federal Clean Air Act 30 times. In private practice with corporate 

law firms, Mr. Wehrum has represented industrial interests in nearly 35 lawsuits that sought to 

weaken or void EPA clean air and public health safeguards. Americans deserve better for the 

nation's chief clean air official. Senators should not confirm him. 

A Record of Lawbreaking 

Mr. Wehrum was a political appointee in the Bush EPA's Office of Air & Radiation from 2001 

to 2007. He served as chieflegal counsel to the head of the air program for nearly 5 years and as 

acting assistant administrator of that program for almost 2 years. 

During Mr. Wehrum's tenure, federal courts found that EPA violated the Clean Air Act 

repeatedly and egregiously. In fact, federal courts found EPA in violation of the Clean Air Act 

while Mr. Wehrum was serving in these senior legal and leadership capacities more often than in 

any other administration before or since. Courts determined that EPA violated the Clean Air Act 

an astonishing 30 times, according to data compiled by EPA's Office of General Counsel for 

Congress.' Of these, 27 losses in court involved retreats from the law's protections for clean air 

and Americans' health, and unlawful exemptions and amnesty for regulated pollution sources. 

I d. 

Few ofEPA's court losses during Mr. Wehrum's tenure involved procedural or analytic 

transgressions. Instead, federal courts found again and again that EPA contradicted and violated 

the "plain language" ofthe Clean Air Act. This is the most egregious way for agencies to violate 

congressionally-enacted laws and repudiate their requirements. For example, the D.C. Circuit 

Court of Appeals found at least three times that EPA air pollution rules contradicted the plain 

1 Letter from U.S. EPA General Counsel, Roger Martella, to the Honorable Henry Waxman 

(April 18, 2008), with attached spreadsheet (both attached here as Attachments I & 2). 
851 


27172.781

meaning of the statutory term, "any."2 Exasperated judges took to quoting Lewis Carroll to 

criticize the upside-down, "Humpty Dumpty" legal arguments advanced by the EPA air program 

under Mr. Wehrum.3 In a 2007 decision late in Mr. Wehrum's tenure, irritated D.C. Circuit 

judges reproached EPA for violating the same congressional command and ignoring plain 

statutory language in three prior D.C. Circuit decisions, reminding EPA how our constitutional 

system oflaws works.4 

In 2006, while Mr. Wehrum was the acting head of EPA's air program, a federal court found that 

EPA's implementation of key air toxics requirements in the Clean Air Act had been "grossly 

delinquent."5 The court found that, "EPA ... currently devotes substantial resources to 

discretionary rulemakings, many of which make existing regulations more congenial to industry, 

and several of which since have been found unlawful." /d. The judge ordered EPA to issue long 

overdue air toxic regulations by 2009, denying the agency's request for a 2012 deadline. /d. 

Mr. Wehrum also played a key role in defending the Bush EPA's refusal to act on the carbon 

pollution that drives dangerous climate change. The Bush EPA air program fought the plain 

language of the Clean Air Act for more than seven years, disputing that the law characterizes 

carbon pollution as an "air pollutant." The Supreme Court decisively rejected that position in 

2007 in Massachusetts v. EPA, ruling that carbon dioxide and other greenhouse gases are "air 

pollutants," just like carbon monoxide or sulfur dioxide, and that the Clean Air Act gives EPA 

the authority and responsibility to regulate them all.6 

Mr. Wehrum departed the agency one month after the Supreme Court's decision. By the end of 

the Bush administration, EPA still had done nothing to regulate the carbon pollution that drives 

dangerous climate change. 

2 See, e.g., New Jersey v. EPA, No. 05-1097 eta/. (Feb. 8, 2008), http://caselaw.findlaw.com/usdc-circuit/1236563.html; Natural Resources Defense Council v. EPA, No. 04-1385 et. a/ (June 8, 

2007), http://caselaw.findlaw.com/us-dc-circuit/l 024879.html; & New York v. EPA, 443 F.3d 

880 (D.C. Cir. 2006), https://casetext.com/case/new-york-v-epa. 3 In one case, DC Circuit federal appellate judges wrote that EPA's explanation "deploy[ ed] the 

logic of the Queen of Hearts, substituting EPA's desires for the plain text of' the law. In 

another decision, judges rejected EPA's arguments and cited Carroll's "Through the Looking 

Glass," writing "[o ]nly in a Humpty Dumpty world would Congress be required to use 

superfluous words while an agency could ignore an expansive word that Congress did use. We 

decline to adopt such a world-view." 4 Sierra Club v. EPA, 03-1202 (March 13, 2007), 

https ://www. cad c. uscourts. gov /internet/ opin i ons.nsf/3 D E6 EA3 9 5 F 4 B40A 6 85 2 57 440004 53 7C 71 

$tile/03-I 202a.pdf. 5 Judge blasts EPA's efforts. He denies request for later deadline, says agency is 'foot dragging' 

on air standards, San Francisco Chronicle (Aug. 4, 2006), 

http://www .sfgate.com/green/article/J udge-blasts-EP A-s-efforts-He-denies-request -2514695 .php 6 No. 05-1120 (April 2, 2007), https://www.law.cornell.edu/supct/pdf/05-1120P.ZO. 
852 


27172.782

A Record of Harming Americans' Health and Air Quality 

Undermining National Health Standard for Fine Particulate Matter 

During Mr. Wehrum's tenure leading EPA's air office, the agency issued a watered-down air 

pollution standard for deadly fine particulate matter, PM2.s. The Clean Air Act requires that 

standard to protect the health of children, elders, and people with heart and lung ailments. Mr. 

Wehrum contradicted the unanimous recommendation of EPA's external science advisors that a 

more protective health standard was needed based on overwhelming medical science. The D.C. 

Circuit Court of Appeals found this rule arbitrary, capricious and unlawful because it 

inadequately protected Americans' heath and air quality.7 

Rolling Back Hazardous Air Pollution Controls for Dirty Power Plants 

Mr. Wehrum's actions in the Bush EPA delivered an illegal, 8-year amnesty period to dirty 

power plants for their emissions of mercury and over seven dozen hazardous air pollutants, like 

lead and arsenic. EPA illegally evaded the protective Clean Air Act safeguards requiring deep 

and timely reductions in all toxic air pollution from each of the nation's coal-burning power 

plant generating units. 

When EPA released its controversial proposal in 2004, it was discovered that industry 

attorneys-from Mr. Wehrum's former law firm-had drafted key language that EPA included 

verbatim in the proposal to let power plant companies off the hook.8 Then, an explosive 2005 

report by EPA's Office of Inspector General found that "EPA senior management" had 

instructed staff to work backward from a pre-determined political outcome, "instead of basing 

the standard on an unbiased determination of what the top performing units were achieving in 

practice," essentially sabotaging the standards that the Clean Air Act required. 9 The Inspector 

General also faulted EPA for "not fully analyzing the cost-benefit of regulatory alternatives and 

not fully assessing the rule's impact on children's health." 10 

Mr. Wehrum's air office then developed a "cap-and-trade" approach for mercury, a potent 

neurotoxin that affects local populations and thus is inappropriate for regional emissions trading. 

His regulation exempted more than seven dozen other hazardous air pollutants emitted by power 

plants, including other neurotoxins such as lead, and carcinogens such as arsenic, benzene and 

7 American Farm Bureau Federation v. EPA, No. 06-1410 eta!. (Feb. 24, 2009), 

http://caselaw.findlaw .com/us-dc-circuit/1209595 .htm I. 8 Eric Pianin, Proposed Mercury Rules Bear Industry Mark, Washington Post (Jan. 31, 2004), 

https:/ /www. washingtonpost.com/archive/po litics/2004/0 I /31 /proposed-mercury-rules-bearindustry-mark/028e 13 79-0026-4bcb-b7ce-l92bbae7b4c6/?utm term=.c0cd6bb0d656. 9 U.S. EPA, Office of Inspector General, Additional Analyses of Mercury Emissions Needed 

Before EPA Finalizes Rules for Coal-Fired Electric Utilities (Feb. 3, 2005), at I I, 

https:/ /www .epa.gov /sites/production/files/20 15 -12/documents/2005 0203-2005 -p-00003 .pdf. 10 !d., at 3. 
853 


27172.783

dioxins.n The cap-and-trade program even allowed individual power plants to increase their 

mercury emissions. 12 EPA emails uncovered through a Freedom oflnformation Act request 

revealed that agency officials pressured states into participating in the mercury trading program, 

by threatening to disapprove state programs that adopted more stringent mercury safeguardsdespite the Clean Air Act's legal guarantee that states may adopt standards more protective than 

federal ones.D 

The Clean Air Act requires coal-burning and oil-burning power plants to install and operate 

modern pollution controls to reduce all their hazardous air pollutants. The law required EPA to 

adopt those standards no later than 2004 and ensure compliance no later than 2007. Due to Bush 

EPA lawbreaking led by Mr. Wehrum, however, EPA flouted this schedule. Following a federal 

court ruling that invalidated the Bush EPA's lawbreaking, 14 the Obama EPA adopted the legally 

required standards in 2012. Thus, EPA lawbreaking fostered by Mr. Wehrum meant that coaland oil-burning power plants did not end up complying with the Clean Air Act until 2015 to 

reduce their dangerous hazardous air pollution. 

In 2012, EPA projected that by 2016 the Obama-issued standards would avoid up to II ,000 

premature deaths and 130,000 asthma attacks every yearY The net health benefits to Americans 

are over $80 billion annually. !d. And each year, the Obama EPA standards are reducing coalburning power plants mercury emissions by 90%, acid gas emissions by 88% and sulfur dioxide 

emissions by 41% beyond what other regulations would have required. 16 The illegal rollback by 

Mr. Wehrum and the Bush EPA denied Americans the totality of these health, environmental and 

economic benefits for eight years. 

Rolling Back Hazardous Air Pollution Controls for All Other Industries 

Mr. Wehrum also pushed a clean air rollback in early 2006 that would have allowed oil 

refineries, chemical plants and other industrial facilities to increase emissions of lead, mercury, 

11 U.S. EPA, Clean Air Mercury Rule (March 15, 2005), 

https://archive.epa.gov/mercurvrule/web/html/rule.html, & Mercury Deli sting Rule (March 15, 

2007), https://archive.epa.gov/mercuryrule/web/pdf/camr final regfinding.pdf. 12 U.S. EPA, Regulatory Impact Analysis of the Final Clean Air Mercury Rule, EPA-452/R-05-

003 (March 2005), https://www3.epa.gov/ttnecas 1/regdata/RIAs/mercury ria final.pd f. 13 Testimony ofJohn Walke, NRDC, The Overturning of EPA's "Clean Air Interstate Rule": 

Consequences and Opportunities (July 29, 2008), at 7-8, 

https://www.epw.senate.gov/public/ cache/files/6/e/6e 18496c-3193-4fl 3-85d4-

c79a947f4020/0 I AFD7973 3 D77F24A 71 FEF9DAFCC B056. walketestimonyoncair72908.pdf. 14 See supra note 2, New Jersey v. EPA. 15 U.S. EPA, FACT SHEET: MERCURY AND AIR TOXJCS STANDARDS FOR POWER 

PLANTS, 

https://www.epa.gov/sites/production/files/20 15-11/documents/20111221 matssummaryfs.pdf~ 16 U.S. EPA, Regulatory Impact Analysis for the Final Mercury and Air Toxics Standards, EPA452/R-11-011 (Dec. 2011), https://www3.epa.gov/ttnecasl/regdata/RIAs/matsriafinal.pdf. 
854 


27172.784

arsenic, benzene and other hazardous air pollutants by many thousands of pounds each. 17 

Officials in 9 of 10 EPA regional offices criticized Mr. Wehrum's plan, calling it "detrimental to 

the environment" and a "drastic change in interpretation" of clean air regulations. Id. The draft 

rollback claimed that even if corporations were given legal permission to save money by 

increasing hazardous air pollution, they would not do so, voluntarily, "to avoid negative publicity 

and to maintain their appearance as responsible businesses." I d. Following public and 

congressional outcries, EPA dropped this air toxics rollback plan. 

Rolling Back Need for Modern Pollution Controls That Apply to Increases in HarmfUl 

Air Pollution 

The Clean Air Act requires industries to install modern pollution controls when they build new 

facilities, or modify existing ones, in ways that lead to significantly higher annual emissions. Mr. 

Wehrum tried to make regulatory changes in 2002-2003 that would have dramatically weakened 

this clean air program. 18 In a 2004 report, the U.S. General Accounting Office reported that 27 of 

44 state official surveyed "expected the [EPA] rule to increase emissions of harmful air 

pollutants, thereby hindering areas' efforts to meet air quality standards and potentially creating 

or exacerbating public health risks." 19 Thirty "of the officials expected their agency's workload 

would increase." Id. 

The D.C. Circuit was so concerned that it issued a judicial stay of this EPA rollback rule two 

days before it was to take effect.20 Such stays are very rare. The judges subsequently held that 

the rollback, once again, violated the plain language ofthe Clean Air Act. Id. Parties had 

presented evidence to the court that the rollback was so drastic, it would have eliminated the 

requirement to install pollution controls at one power plant increasing harmful emissions, like 

smog-forming nitrogen oxides, by over 21,000 tons per year.21 

17 E.P.A. Emissions Plan Is Criticized as Harmful to the Environment, N.Y. Times (April4, 

2006), 

http:/ /query.n vtimes.com/gst/fu llpage.html?res=9C06E3 D613 30F93 7 A3 5757COA 9609C8B63. 18 U.S. EPA, Prevention of Significant Deterioration (PSD) and Non-Attainment New Source 

Review (NSR): Equipment Replacement Provision of the Routine Maintenance, Repair and 

Replacement Exclusion (Oct. 27, 2003), 

https:/ /www. federalregister. gov I docum ents/200 3/ I 0/2 7/03-263 2 0/prevention -of-significantdeterioration-psd-and-non-attainment-new-source-review-nsr-equipment. 

19 U.S. GAO, Key Stakeholders' Views on Revisions to the New Source Review Program, GA0-

04-274 (Feb. 2004), at 2 https://www.gao.gov/assets/250/241349.pdf 20 See New York v. EPA, No. 03-1380 (March 17, 2006), at 6 (noting judicial stay of rule in 

December 2003), 

https :/ /www .cadc.uscourts.gov /internet/opinions.nsf/DD61 I C38C F556 DD68525 7 4400044 D63 71 

$file/03-1380a.pdf. 

21 Opening Brief of Environmental Petitioners and Intervenors, State of New York v. EPA, No. 

03-1380 eta/. (Sept. 8, 2005), at 14-15. For comparison, this amount is nearly one-and-a-half 

times the total amount of nitrogen oxides emissions annually by all sources located in the District 

of Columbia. State Emissions Totals (NEI 1999 v3), 

www.emissionsonline.org/nei99v3/state/stindex.htm. 
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Undermining Clean Air Act Enforcement 

Even the Bush EPA's own enforcement office protested Mr. Wehrum's 2003 rollback of these 

new source review regulations, finding that an astonishing "88 percent of [EPA's] pending 

enforcement cases" against coal-burning power plants would have been impossible under the 

expansive amnesty that the rollback conferred.22 The political appointee heading EPA's 

enforcement office argued internally that these rollbacks would "eviscerate the air enforcement 

program," particularly as it impacts coal-fired utilities.23 

A subsequent politically appointed head of the Bush EPA enforcement office related that the 

goal of Mr. Wehrum's air program clean air rollbacks "was to prevent any enforcement case 

from going forward. Some people thought the [agency's power plant enforcement initiative] 

should never have been brought. [The air program's] reform was really designed to thwart our 

ability to do it. "

24 As noted, the D.C. Circuit subsequently stayed, then vacated, the rollback 

unanimously.25 

Undermining States' Rights to Regulate Motor Vehicle Greenhouse Gas Emissions 

As acting administrator of the EPA air office, Mr. Wehrum recommended against granting 

California's Clean Air Act Section 209 waiver to regulate greenhouse gas emissions from 

vehicles.26 This decision had negative implications for a third of the nation's vehicle market, and 

represented the first and only time EPA has denied a waiver since California was granted preemption authority in 1967. 

A Record of Advancing a Polluting Agenda for Industries 

EPA lawbreaking during Mr. Wehrum's tenure in the Bush administration advanced an industry 

agenda to increase harmful air pollution and weaken clean air protections for all Americans. Mr. 

Wehrum has continued to pursue that agenda in his role as a corporate attorney representing 

industry. 

22 EPA, Office of the Inspector General, New Source Review Rule Change Harms EPA's Ability 

to Enforce Against Coal-fired Electric Utilities, Evaluation Report No. 2004-P-00034 (Sept. 30, 

2004), at 18 ("2004 NSR OIG Report"). 23 !d., at 11. 24 Joel A. Mintz, 'Treading Water': A Preliminary Assessment of EPA Enforcement 

During the Bush II Administration, 34 ELR 10933, 10937-40 (Oct. I, 2004) (quoting J.P. 

Suarez). 

25 See supra note 20. 26 Richard Simon & Janet Wilson, EPA staff turned to former chief on warming, L.A. Times 

(Feb. 27, 2008) (discussing email in which Wehrum argued against granting the waiver as far 

back as 2006). http://articles.latimes.com/2008/feb/27/nation/na-waiver27; Global Warming 

Waiver Documents Show "An Environmental Protection Agency in Crisis (Feb. 26, 2008), 

https :/ /www. epw .senate. go v /pub I ic/index.cfm/press-releases-democratic? 10=5 6 8 8A 3 60-802A23AD-4441-77F52C3C 17B6. 
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As a private attorney, Mr. Wehrum has represented corporations and trade associations in 34 

lawsuits involving the EPA. Attachment 3 to this letter lists these cases.27 The clear majority of 

the cases were lawsuits against EPA to weaken or overturn clean air and health protections. A 

few cases involved intervening on EPA's side to defend weak requirements that the petitioners 

believed the law requires to be strengthened. 

We have not identified any case in which Mr. Wehrum represented a client that sought to 

strengthen clean air protections. Mr. Wehrum even sued the Occupational Health and Safety 

Administration opposing workplace exposure safeguards for dangerous respirable silica.28 

Mr. Wehrum's conflicts of interest letter to EPA's Designated Agency Ethics Official indicates 

no intention to recuse himself from the large number of Clean Air Act matters that he is currently 

suing to overturn or weaken on behalf of industry clients.29 Mr. Wehrum does not have an open 

mind about these standards and the legal, scientific and policy elements that contradict his 

private clients' positions and interests. Moreover, Mr. Wehrum's letter indicates an intention to 

recuse himself for only a limited duration from actual litigation against EPA in which he has 

participated personally and substantially. I d. If he is confirmed, Mr. Wehrum should recuse 

himself permanently from all future aspects of EPA Clean Air Act standards that are the subject 

of all his lawsuits against EPA on behalf of private clients. 

A Mixed Record of Improving Public Health and Air Quality 

EPA's air program did achieve some important air pollution reductions during Mr. Wehrum's 

tenure. The Bush EPA continued the Clinton administration's successful diesel emissions work, 

and launched their own efforts to control previously unregulated diesel engines. Building on 

interstate pollution reductions for smog-forming nitrogen oxides in the Clinton administration, 

and acting in response to petitions by frustrated downwind states, the Bush EPA's Clean Air 

Interstate Rule accomplished significant reductions in deadly sulfur dioxide and nitrogen oxides 

emissions from coal-burning power plants in the eastern U.S. A unanimous D.C. Circuit did find 

this rule unlawful, however, after concluding that the Clean Air Act requires power plants to 

make more reductions in these pollutants than the rule accomplished, in order to help downwind 

states like North Carolina.30 Mr. Wehrum and the Bush EPA deserve credit for 

these achievements, even though the law required, and the Obama administration delivered, 

deeper pollution reductions. 

27 The list in Attachment 3 is limited to cases in the federal appellate courts in which Mr. 

Wehrum represented a party. It does not include any cases in federal district courts or state courts 

in which he may have participated. In addition, the list exceeds 34 EPA cases, because some of 

the cases were consolidated into a single case. This reduces the 68 listed cases involving EPA to 

34 overall cases. 28 See Attachment 3; https://www.hunton.com/en/people/williarn-wehrum.html. 29 Letter from William Wehrum to Kevin Minoli, Designated Agency Ethics Official, U.S. EPA 

(undated), https://www.eenews.net/assets/2017/09/15/document pm 04.pdf. 30 North Carolina v. EPA, http://caselaw.findlaw.com/us-dc-circuit/1336309.html. 
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A Record of Damning Government Investigations 

During Mr. Wehrum's tenure at EPA, there was an explosion of critical investigations and 

reports by independent watchdogs in the agency's Office of Inspector General (OJG) and by the 

Government Accountability Office. These government auditors directed sharp criticism at the 

hannful and frequently illegal clean air rollbacks overseen by Mr. Wehrum. Some of these 

examples include: 

The General Accounting Office's 2003 report, EPA Should Use Available Data to 

Monitor the Effects of Its Revisions to the New Source Review Program, detennined that 

EPA's justifications for 2002 rollbacks to a clean air program were based on self-serving, 

unsubstantiated anecdotes submitted by industry, rather than on reliable data. 31 

The EPA Office of the Inspector General's 2004 report, New Source Review Rule Change 

Harms EPA's Ability to Enforce Against Coal-fired Electric Utilities, found that a 2003 

clean air rollback shepherded by Mr. Wehrum had "seriously hampered [EPA 

enforcement office] settlement activities, existing enforcement cases, and the 

development of future cases."32 The OIG related that "[t]hree of nine utilities in ongoing 

active litigation with EPA [had] asserted that enforcement actions should cease or be 

significantly reduced" because their alleged violations would be acceptable under the 

rollback. !d. Soon after the rollback was made public, "a major utility ceased negotiations 

with EPA" and "[n]o new enforcement actions [were] taken against coal-fired utilities 

alleged to have violated the [old rule] due to the new rule's adverse impact on [the EPA 

enforcement office's]leverage in settlements or court remedies." !d. at ii-iii. As noted 

above, a federal court stayed and subsequently vacated the 2003 rollback.33 

The Government Accountability Office's 2005 report, Observations on EPA's CostBenefit Analysis of Its Mercury Control Options, identified major shortcomings in the 

economic analysis for EPA's proposed mercury cap-and-trade program. 34 For example, 

EPA examined the costs and benefits of the trading approach, but not the actual Clean Air 

Act requirement that EPA chose to roll back. This skirted examining which approach 

produced the greatest net benefits, leading GAO to conclude, "EPA's estimates are not 

comparable and are of limited use for assessing economic trade-offs." Id. 

The Government Accountability Office's 2006 report, EPA Should Improve the 

Management of Its Air Taxies Program, strongly criticized EPA for failing to act on 

scores of specific toxic air pollution control measures that Congress required the agency 

to complete years earlier. 35 GAO concluded that "as a result of EPA's limited progress, 

the agency has not addressed health risks from air toxics to the extent or in the time 

frames envisioned in the Clean Air Act." I d. 

The Government Accountability Office's 2006 report, Particulate Matter: EPA Needs to 

Make More Progress in Addressing the National Academies· Recommendations on 

Estimating Health Benefits, found EPA had failed to fully apply 26 recommendations by 

31 GA0-03-947 (Aug. 2003), at 4-5, 16-25, http://www.gao.gov/assets/240/239346.pdf. 32 2004 NSR OIG Report, supra note 22, at ii. 33 See supra note 20, New York v. EPA. 34 GA0-05-252 (Feb. 2005), http://www.gao.gov/new.items/d05252.pdf. 35 GA0-06-669 (June 2006), https://www.gao.gov/assets/260/250607.pdf. 
858 


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the National Academies for improving its benefits analysis for the national health 

standards for particulate matter pollution.36 

CONCLUSION 

Mr. Wehrum has dedicated his career to rolling back EPA health and clean air protections for 

Americans, both while at EPA and in service of industry clients. His record does not show the 

necessary dedication to achieving the Clean Air Act's imperative to "protect and enhance the 

quality of the Nation's air resources so as to promote the public health and welfare and the 

productive capacity of the population."37 

During Mr. Wehrum's prior tenure in EPA's air office, the agency's accomplishments were 

overshadowed by extraordinarily harmful rollbacks and delays, and frequent court losses and 

rebukes from judges. He left Americans to suffer from dangerous and unlawful air pollution for 

many years after his tenure ended. 

Mr. Wehrum is a knowledgeable air pollution attorney, but he is not fit for the job as the nation's 

chief air quality official. We respectfully urge Senators not to confirm him to this position. 

Sincerely, 

Center for Biological Diversity 

Earth justice 

Friends of the Earth 

League of Conservation Voters 

National Parks Conservation Association 

NRDC 

Save EPA 

Sierra Club 

Voices for Progress 

36 GA0-06-992T (July 2006), http://www.gao.gov/assets/120/114447.pdf. 
859 


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37 42 U.S.C. § 740I(b). 
860 


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October 4, 2017 

Senator John Barrasso, Chairman 

Senate Committee on Environment and Public Works 

410 Dirksen Senate Office Building 

Washington, DC. 20510 

Senator Thomas Carper, Ranking Member 

Senate Committee on Environment and Public Works 

465 Dirksen Senate Office Building 

Washington, DC. 20510 

TASK FORCE 

RE: Opposition to the Nomination of William L. Wehrum as Assistant Administrator for 

the U.S. Environmental Protection Agency's Office of Air & Radiation 

Dear Chairman Barrasso and Ranking Member Carper: 

On behalf of Clean Air Task Force (CA TF), we write you in opposition to the nomination 

of William L. Wehrum to be the Assistant Administrator in the Office of Air & Radiation of the 

United States Environmental Protection Agency (EPA or Agency). CATF is a non-profit 

organization, whose lawyers, scientists, policy analysts and engineers work towards public health 

improvements under the Clean Air Act, including safeguarding against the worst impacts of 

climate change, through the rapid global development and deployment of low carbon energy and 

other climate-protecting technologies. 

Since our founding in 1996, it has generally been CATF's policy not to comment on, endorse, or 

oppose nominees for agency posts. We are breaking with our general practice in this instance, 

due to Mr. Wehrum's long history of opposition to protections for public health and welfare, 

both during his previous tenure at the Agency and in his subsequent representation of industrial 

and commercial clients. These issues are well documented by the Natural Resources Defense 

Council in their September 19, 2017 letter to you, and we will not repeat them here. We note 

however that when Mr. Wehrum served in senior leadership positions with the EPA air program 

during the George W. Bush administration, courts held the Agency in violation of the federal 

Clean Air Act 30 times, and while in private practice, Mr. Wehrum has represented private 

interests opposed to Clean Air Act regulation. Furthermore, Mr. Wehrum's August 28,2017 

letter on file with the Agency's Designated Ethics Official does not provide sufficient 

commitment to recuse himself to eliminate the appearance of conflict, given Mr. Wehrum's 

ongoing activity representing clients against the Agency. 

114 State Street. 6'h floor I Boston, MA 02109 I www.catf.us 1 617.624.0234 
861 


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Page 2 of2 

The evidence suggests that Mr. Wehrum will not act in the best interests of American 

breathers, nor in the interests of environmental improvement, including taking steps to safeguard 

against the worst impacts of climate change, if he is appointed to the post to which he has been 

nominated. He should not be confirmed to lead the Office of Air & Radiation. 

For: 

Thank you for your consideration, 

Armond M. Cohen, Executive Director 

Ann Brewster Weeks, Legal Director 

Conrad Schneider, Advocacy Director 

Clean Air Task Force 

114 State Street, 6'" floor 

Boston, MA 02!09 

617-624-0234 
862 


27172.792

CENTER FOR 

Science JN THE 

Public Interest 

September 19, 2017 

Dear Chairman Barrasso and Ranking Member Carper: 

The Center for Science in the Public Interest writes to strongly oppose the nomination of Michael 

Dourson to lead the Office of Chemical Safety and Pollution Prevention at the U.S. Environmental 

Protection Agency. 

For decades, Dourson has consistently underestimated the health impacts of food chemicals, typically 

while he or his organization acted as a consultant, expert witness, or paid researcher for the food and 

chemical industries. In particular, Dourson or his firm's employees underestimated the potential harm of 

acrylamide (a carcinogen), diacetyl (a cause of lung disease), and perchlorate (which poses developmental 

risks), as well as pesticides linked to cancer or neurodevelopmental effects. 

For example, after conducting a safety review ofacrylamide, Dourson proposed a safety estimate that, 

according to the Center for Public Integrity and lnsideClimate News, was 10 times less protective of the 

public's health than the standard developed by EPA scientists. The study was funded by major food 

companies, including Burger King, Frito-Lay, KFC, and McDonald's. 

Dourson's firm also sought to weaken the safety estimate for diacetyl, which can cause a fatal lung 

disease in workers, after receiving funding from a consortium of food companies, including Cargill, 

Coca-Cola, ConAgra, Frito-Lay, General Mills, J.M. Smucker, Land O'Lakes, Procter & Gamble, and 

Unilever. Employees ofDourson's firm proposed an occupational exposure limit of200 parts per billion, 

which is 40 times less protective than the standard recommended by the National Institute for 

Occupational Safety and Health, 

Moreover, in April 2016, Dourson testified for Croplife, the pesticide trade association. And, unlike the 

EPA staff scientists he would oversee (but consistent with the views of this administration's political 

appointees), he argued in favor of the continuing use of current levels of chlorpyrifos, a pesticide linked 

to brain damage. Dourson also proposed weak safety estimates for breakdown products of alachlor and 

acetochlor, two herbicides linked to cancer and banned in the European Union. 

In light of his long record of seeking to weaken chemical safety protections on behalf of chemical 

industry clients, Michael Dourson should never have been nominated to lead that industry's primary 

regulator. I strongly urge you to reject his nomination. 

Sincerely, 

Peter G. Lurie, MD, MPH 

President 
863 


27172.793

Dollloon !.'>a !()XK caJHhdme 10 heud the F.PA Olllce nfCh~tm...a! Sal\~!y ami Polh;twn Prev~ntwn 

~~-- _ -_- ~ ~-~-~~ _~?~~s~~£i~2~i~-~~~=--= _- --~ 

- - - -

TAKE ACTION: Dourson is a toxic candidate to head the 

EPA Office of Chemical Safety Pollution Prevention The Trump Administration h<Js nom mated Michael Dourson to head the EPA Office of ChemiCBI Safety and Pollution Pr;;ventwn (OCSPP), the office 

charged With revieWing and ensunng the safety of cherr11cals, 111clud1ng pcst•c1des like chlorpynfos and many others. 

Alarmingly, Courson has spent much of his professional career receiving 

payment from chl;!mical companies and the1r trade assocmtiDns to publish papers 

and studieS that underm1ne exiSting sc1ence and concerns about tox1c chemicals, 

call for weaker regulations on chemiCals. 

On chlorpyrifos specifically, Dourson Wl'lS paid by Dow A.grosciences to 

downplay concerns about the chemical and cast doubt on 3 Columbia un1vf!rS1ty 

study lmkmg prenatal exposures to chlorpynfos to 1rreversibk' neurodevelopmental 

problems in ch!ldren. ln oth,:;r words, to h1de the fact that chlo•pynfos IS dangerous 

kids. Really dangerous. 

!n a nutshell, Dourson is a threat to the health and safety of children and 

farm workers across the country, 

"Th1s Wednesday, the Senate Env1ronment and Public Works Committee wllll1old a h:aring on h\s nomination, Join us in telling your senators to 

oppose Michael Dourson. 

To get started, enter your zip code below and click 'Participate' 

'W' htfkd i<'ann Worii;ers I© UNITED FARM WORKFRS I P-0. ROX 62, KF.ENE, CA 9J531j CONrACT US I PRiVACY POLICY 
864 


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September 19, 2017 

The Honorable John A. Barrasso 

Chairman 

AMERICAN 

SUSTAINABLE 

BUSINESS 

CouNCIL 

The Honorable Thomas R. Carper 

Ranking Member 

Environment and Public Works Committee 

United States Senate 

Environment and Public Works Committee 

United States Senate 

410 Senate Dirksen Office Building 

Washington, DC 20510 

456 Senate Dirksen Office Building 

Washington, DC 20510 

RE: Nomination of Michael Dourson, Environmental Protection Agency's Office of Chemical Safety And 

Pollution Prevention 

Dear Chairman Barrasso and Ranking Member Carper: 

The American Sustainable Business Council (ASBC), with a national network of members representing over 

250,000 businesses, strongly opposes the nomination of Michael Dourson to lead the Environmental 

Protection Agency's Office of Chemical Safety and Pollution Prevention. 

As the head of the industry-funded Toxicology Excellence for Risk Assessment, or TERA, Mr. Dourson 

repeatedly sought to weaken standards to protect families from dangerous chemicals, including chemicals 

linked to cancer, brain damage, and reproductive harm. Thirty to forty percent of TERA's funding came from 

the chemical industry to produce studies favoring weaker safety standards, and industry-funded studies 

made up more than half of the studies peer-reviewed by TERA since 1995. 

The office Mr. Dourson has been nominated to head will be responsible for the risk evaluation and 

subsequent regulation of chemicals under the updated Toxic Substances Control Act, which Mr. Dourson 

sought to dramatically weaken after receiving funding from members of the chemical industry. 

At a time when many businesses are successfully producing non-toxic products and consumers want stricter 

protections against harmful products and pesticides, Dourson has consistently argued for weaker standards 

and helped companies avoid liability for damages resulting from chemical pollution. Weaker standards for 

harmful chemicals not only increase risk of exposure, but the absence of meaningful safety standards also 

undermines consumer confidence across the spectrum of industries affected. 

Given the funding that he has received over the years to produce studies on behalf of the chemical industry, 

we do not believe that Mr. Dourson would be independent in leading EPA's regulation of chemicals and 

pesticides. We encourage you to reject his nomination. 

Respectfully submitted, 

~o.D~ 

David levine, CEO 

TEl: 2.02.595.9302 

1001 G STREET NW, SUITE 400E 

WASHINGTON DC 20001·4559 

ASBCOUNC!l.ORG 
865 


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September 26, 2017 

The Honorable John Barrasso 

Chair 

Comm. on Environment and Public Works 

410 Dirksen Senate Office Building 

Washington, D.C., 2051 0 

Dear Senators Barrasso and Carper: 

Senator Thomas R. Carper 

Ranking Member 

VIA EMAIL 

Comm. on Environment and Public Works 

456 Dirksen Senate Office Building 

Washington, D.C., 20510 

As organizations committed to protecting reproductive rights, health, and justice, we are writing 

to express our concerns regarding the nomination of Michael Dourson to head the Office of 

Chemical Safety and Pollution Prevention at the Environmental Protection Agency (EPA). Mr. 

Dourson has long worked with corporations and industry groups to downplay or dismiss the 

harmful health effects of chemical industry products and, in particular, the risks these products 

pose to reproductive health. 

Mr. Dourson has sought to weaken chemical safety standards on behalf of industry clients, yet he 

has been nominated to a position charged with establishing government safety standards for 

those very chemicals. Specifically, he has argued for weaker safety standards for chemicals 

linked to harm to individuals' reproductive health, such as 1-Bromopropane, TCE, and flame 

retardant chemicals. If confirmed, Dourson would be charged with establishing government 

safety standards for these chemicals, all of which are slated for EPA action in the next few years. 

Mr. Dourson also has a long record of proposing weaker safety standards for pesticides, many of 

which can interfere with the developing brain of children who were exposed to the chemicals in 

utero or as infants or toddlers. And the chemicals Mr. Dourson would be charged with regulating 

have been linked to a host of reproductive harms, including infertility, cancer, and even the early 

onset of puberty. 

While all people can be harmed by dangerous chemicals, the risks are not shared equally. People 

of color and people who are struggling to make ends meet are more likely to be exposed to 

hazardous chemicals or conditions, including chemical spills and disasters, than other groups. 

People of color also are more likely to work in industries in which they are exposed to toxic 

chemicals. Migrant farm workers, who are consistently exposed to dangerous pesticides, are 

overwhelmingly Latinx. Nail salon workers, who are overwhelmingly women and a majority of 

whom are women of color, are exposed to products that contain a host of toxic chemicals that 

may cause reproductive harm and cancers. And women especially Black women -are more 

likely to be exposed to toxic chemicals in personal care products. 

The EPA is supposed to protect our families from chemicals that can harm our health. Mr. 

Dourson's record of seeking to weaken chemical safety standards, however, raises serious 

concerns about his ability to vigorously protect the public. We urge you to carefully consider the 

impacts of chemical safety on reproductive health as you make the critical decision of whether 

Mr. Dourson is fit to head the office of Chemical Safety and Pollution Prevention. 
866 


27172.796

Sincerely, 

Black Women's Health Imperative 

Center for Reproductive Rights 

If/When/How 

In Our Own Voice: National Black Women's Reproductive Justice Agenda 

National Asian Pacific American Women's Forum 

National Council of Jewish Women 

National Health Law Program 

National Institute for Reproductive Health 

National LGBTQ Task Force Action Fund 

National Latina Institute for Reproductive Health 

National Organization for Women 

National Partnership for Women & Families 

National Women's Health Network 

National Women's Law Center 

PAl 

Physicians for Reproductive Health 

Planned Parenthood Federation of America 

Sexuality Information and Education Council of the United States 

URGE: Unite for Reproductive & Gender Equity 
867 


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September 19, 2017 

The Honorable John Barrasso 

Chairman 

Committee on Environment and Public Works 

410 Dirksen Senate Office Building 

Washington, DC 20S10 

The Honorable Thomas R. Carper 

Ranking Member 

Committee on Environment and Public Works 

4S6 Dirksen Senate Office Building 

Washington, DC 20510 

Dear Senators Barasso and Carper: 

We write to urge you to oppose the nomination of Michael Dourson to be Assistant Administrator of 

EPA's Office of Chemical Safety and Pollution Prevention. Dourson has spent decades playing down 

concerns about toxic chemicals for his industry clients-chemicals tied to cancer, infertility, severe lung 

damage, developmental impairment and other serious health concerns. 

From his work on tobacco to his work defending chemicals like PFOA, TCE, chlorpyrifos, and 1,4-dioxane 

that are impacting communities across the country, Dourson has proven to be a reliable ally for industry 

clients rather than someone who will work to protect public health and the environment, as this 

position requires. 

The position Dourson would hold at the helm of EPA's taxies office is of critical importance to public 

health and the environment. If confirmed, Dourson would oversee implementation of the newly 

amended Toxic Substances Control Act {TSCA). The reforms made last year to TSCA provide a significant 

opportunity to better ensure that chemicals used in products and materials we encounter every day in 

our homes, schools and workplaces are safe. Critical decisions about the implementation of the 

reformed law will fall to the current EPA and to the person leading this office. 

Dourson would also lead the EPA program charged with ensuring the safety of pesticides under the 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). In light of the controversial decision made by 

Administrator Scott Pruitt to reject the recommendations of EPA scientists to ban chlorpyrifos, the 

credibility of the pesticide review process cannot afford to be further compromised. 

Unfortunately, Michael Dourson is the wrong man for this job. Over the last two decades, Dourson has 

worked as a toxicologist-for-hire, with his firm Toxicology Excellence for Risk Assessment (TERA), 

recently migrated into a center at the University of Cincinnati. Contrary to TERA and the center's claims 

of "independence," they have deep financial ties to the chemical industry, tobacco industry, and other 

major corporations and industry groups-many of the same entities he would now be charged with 

regulating. 
868 


27172.798

In fact, Dourson or his firm have been paid by dozens of chemical companies or trade associations to 

work on dozens of different chemicals. Those chemicals include several that are right now under active 

review by the very office Dourson has been nominated to lead, including trichloroethylene (TCE), 1,4-

dioxane and chlorpyrifos. 

Compounding the concern is that Dourson's firm routinely played down health concerns about the 

chemicals his clients produced or used. As multiple news articles have documented, Dourson and his 

firm have been the go-to firm for companies seeking to lessen or muddy concerns and press for less 

health-protective standards. 

His work for industry went beyond science issues to include developing and running the website 

"kids+chemicalsafety.org" that was funded by the main chemical industry trade association. While it 

promised information about "chemical hazards and safe use of chemicals around children," the website 

actually delivered chemical industry spin that shifted the burden of protection onto parents and 

consumers, for example, by suggesting that parents concerned about toxic chemicals in toys ensure that 

children keep the toys out of their mouths and wash their hands after playing with them. 

Such a long record of down playing concerns about toxic chemicals means that Dourson should not be 

entrusted with protecting our children and families from toxic chemicals. Please reject Michael 

Dourson's nomination. 

Sincerely, 

Center for Biological Diversity 

Clean Water Action 

Earthjustice 

Environmental Defense Action Fund 

Environmental Working Group 

Friends of the Earth 

Green For All 

Hip Hop Caucus 

league of Conservation Voters 

Moms Clean Air Force 

Physicians for Social Responsibility 

Power Shift Network 

Public Citizen 

Save EPA 

Sierra Club 

Union of Concerned Scientists 

CC: Members of the Committee on Environment and Public Works 
869 


27172.799

Board of Directors 

John Applegate 

Alyson Flournoy 

Robert Glicksman 

Alice Kaswan 

Alexandra Klass 

Thomas McGarity 

Sidney Shapiro 

Amy Sinden 

Robert R.M. Verchick 

Advisory Council 

Patricia Bauman 

Frances Beinecke 

Eula Bingham 

W. Thompson Comerford, Jr. 

Sally Greenberg 

John Passacantando 

Henry Waxman 

Robert Weissman 

September 19, 2017 

Chairman Barrasso 

410 Dirksen Senate Office Building 

Washington, D.C. 20510 

Ranking Member Carper 

456 Dirksen Senate Office Building 

Washington, D.C. 20510 

Re: Nomination of Michael Dourson for Assistant 

Administrator for EPA's Office of Chemical Safety and 

Pollution Prevention 

Chairman Barrasso, Ranking Member Carper, and Members of the 

Committee: 

We urge you to oppose the nomination of Dr. Michael Dourson to 

head EPA's Office of Chemical Safety and Pollution Prevention 

(OCSPP). Our concerns about his fitness for the position arise out of 

research conducted by the Center for Progressive Reform concerning 

his work with the consulting firm Toxicology Excellence for Risk 

Assessment (TERA). 

Cozying Up: How Manufacturers of Toxic Chemicals Seek to Co-opt 

Their Regulators, the report based on that research, is attached. 

Key findings from the report most relevant to your committee's review 

of Dr. Dourson's nomination include: 

• When state regulators in Wisconsin began to consider limits on 

the chemical byproducts produced when two widely used herbicides 

break down in the environment, the manufacturers of the herbicides 

hired TERA to convene an expert panel to develop a "reference dose" 

(RfD) for the chemicals. (An RfD is an estimate of the daily oral 

exposure to a chemical that will not result in adverse health effects.) 

The result was an article co-authored with government scientists that 

advocated drinking water limits up to 280 times higher than the limit 

Wisconsin regulators had set. 

Significant amounts of TERA's funding derived from 

corporations (e.g., Boeing, Alcoa) and government agencies (e.g., 

www.progressivereform.org 

455 Massachusetts Ave., NW #150-5131 Washington, DC 120001 

202-747-06981 @CPRBiog 
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CPR Professors' letter re Dourson nomination 

Sept. 19, 2017 

Page 2 of 3 

Department of Defense) that could reduce compliance and cleanup costs if risk 

assessment policies and findings by regulatory agencies do not meet the bold 

public health goals Congress set in our toxic chemicals, clean air, and clean 

water laws. 

• Chemical manufacturers have taken advantage of agency scientists' interest in 

professional development by fostering the growth of organizations like I LSI and 

TERA, which blur the lines between professional development and policy 

advocacy. For instance, after National Academy of Sciences' National Research 

Council published the Silver Book, TERA set up a committee (the affiliated 

Alliance for Risk Assessment's Beyond Science and Decisions) to partner with 

agency scientists in order to increase their influence over future federal agency 

risk assessment practices. Government scientists' participation in such activities 

undermines EPA's independence and objectivity. 

Based on Dr. Dourson's past work with TERA, we have serious concerns about his 

potential biases in favor of regulated industry over EPA's public health mission, as well 

as the likelihood that he will pursue partnerships with outside organizations in a way that 

gives undue influence to regulated parties. 

We urge you to oppose Dr. Dourson's nomination and insist that President Trump 

nominate someone for this important position who will put public health and 

environmental safety first. 

Sincerely, 

Alejandro E. Camacho 

Professor of Law and Director, Center for Land, Environment, and Natural Resources 

University of California, Irvine School of Law 

David M. Driesen 

University Professor 

Syracuse University 

Carmen G. Gonzalez 

Professor of Law 

Seattle University School of Law 

Alice Kaswan 

Professor of Law 

University of San Francisco School of Law 

Mary L. Lyndon 

Professor 

St. John's University School of Law 
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CPR Professors' letter re Dourson nomination 

Sept. 19,2017 

Martha McCluskey 

Professor 

University at Buffalo, SUNY 

Thomas 0. McGarity 

Professor of Law 

University of Texas School of Law 

Joel A Mintz 

Professor of Law 

Nova Southeastern University College of Law 

Sidney A Shapiro 

Frank U. Fletcher Chair in Administrative Law 

Wake Forest University 

Karen C. Sokol 

Associate Professor of Law 

Loyola University New Orleans College of Law 

Rena I. Steinzor 

Edward M. Robertson Professor of Law 

University of Maryland Francis King Carey School of Law 

• Affiliations are listed for identification purposes only. 

Page 3 of 3 
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by CPR Member Scholar Rena Steinzor 

and Policy Analyst Wayland Radin 
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CENTER FOR 

I'RO<;RESSIVE REfORM 

WHITE PAPER #1211 

September 2012 

Acknowledgments 

The Center for 

Progressive Reform 

Is grateful to the 

John Merck Fund 

and the Johnson 

Family Foundation. 

Center for Reform 

About the Center for Progressive Reform 

Founded in 2002, the Center for Progressive Reform is a 501(c)(3) nonprofit research 

and educational organization comprising a network of scholars across the nation dedicated 

to protecting health, safety, and the environment through analysis and commentar-y. CPR 

believes sensible safeguards in these areas serve important shared values, including doing the 

best we can to prevent harm to people and the environment, distributing environmental 

harms and benefits fairly, and pro(ening the earth for future generations. CPR rejects 

the view rha< the economic efficiency of private markets should he the only value used 

to guide government action. Rather, CPR supports thoughtful government action and 

reform to advance the weH~being of human life and the environment. Additionally, CPR 

believes people play a crucial role in ensuring hoth private and pub!lc sector decisions that 

result in improved protection of consumers, public health and safety, and the environment. 

Accordingly, CPR supports ready puh!ic access to the courtS, enhanced public participation, 

and improved public access to infOrmation. 1he Center for Progressive Reform is grateful 

ro the John Merck Fund and the Johnson Family Foundation for their support of our taxies 

work. 

For more information about the authors, see page 17. 

For media inquiries, contact Matthew Freeman 

or Ben Samberg 

For general information, emailffi!()(<Vprnrrcs:.iverc!Orm.org. 

© 2012 Center for Progressive Reform. 

Coverphoto:©HortdV:tr!dn. 
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Center for Proa1ressiive Reform 

Deceptive Partnerships 

Given the charged debate in \X!ashington over proposals to impose environmental or health 

and safety restrictions on industry, Americans might reasonably assume that toxic chemicals 

undergo rigorous, independent testing he fore 1hey enter the stream of commerce. ll1c reality 

of chemical regulation is disturbingly different and Euless protecrive of public heahh and the 

environment. When Congress passed the 1976 Toxic Substances Control Act (TSCA)--<me 

of the most important federal statutes to reguLne potentially dangerous chemical products~ 

tens of thousands of chemicaLs were "grandfarhered," me,wing ther were al!owed to remain 

on d1e market without additional tests to prove their safery. 1 1he tens of thousands of new 

chemicals that have come on the market over rhe last 35 years undergo a perfunctory, 90-day 

"pre-manufacture review" by the Environmental Protection Agency (EPA), which under 

even the be~t circumstances must rdy on a comparison of the chemica! structure of the new 

chemical to the structures of existing chemicals and whatever informuion the manufacturer 

has chosen to submit reg;~rding the chemicaL 'This "hear no evil, see no evil" system means 

that the hazards of chemical exposure are oflen revealed long after a chemical is pervasive 

in the environment. Bisphenol A is sri!! used in a host of consumer products despite the 

facr that scientific studies !ink it to increased susceptibility to prostate and breast cancers, 

reproductive system defects and abnormalities, hormonal imbalances, brain development 

abnormalities, ~ender confusion, heart disease, and diabetes. 1 

As troubling, when rhe toxic effects of exposure roan untested chemical emerge, regularors 

mmt depend on "best available" science in order to decide whether to restrict the ways 

the chemical is marketed and used.; This ,tppro,tch gives nunufactmers strong incentives 

to generate their own studies exonerating rheir products in an effort not only to keep 

chemicals on the market without restrictions bur also to avoid liability for injuries caused 

by past exposures. 

Because research hy a chemical's producer is often the primary resource available to 

regulatOrs who make crncial public health decisions, independent experts have examined 

whether industry-sponsored studie.'> produce difTerent results dun comp;~r.1ble governmentfunded work. 'lhese analyses cover a wide range or adverse effects, but rhey :d! reveal rhat 

indusrry sponsorship m<1kes it :.ignificantly more likely that these studies reach conclusions 

more ravorable to rhe sponsors than would research conducted by neutral scientists. An 

empirical review of l ,140 biomedical studies determined that "industry-sponsored studies 

were significantly more likely w reach conclusions that were favorable to the sponsor than 

were non-industry studies." 4 Concerned by these tindings, but unwilling to reject industrysponsored science out of hand, rhe world's most pn·stigious scientific journals ref!uire authors 

to disclose the source of their work so that potential biases are evident to readers.' These 

disclosures alert readers to the need to scrutinize study design, imp!ernentation, and findings 

more carefully. 

Chemical manufacturers have long chafed under these restrictions because they know 

that once a smdy is labeled as an industry work product, most people are unwilling to 
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2 Center for Reform 

take its conclusions at face value, and some will find them unconvincing on any level. 

"fhis discomfort has generated ,t search fOr ways to make industry research appear more 

ct<'dihk. One of the most effective rucdwds of doing so is to recruit government sdemists 

as co-authors for journal articles about the chemical in question. A second strategy is 

ro obrain the acrive participation of government officials in indusrry~sponsorcd effons 

to formulate "conscn.sus" policy pronouncements regarding research design and risk 

J.ssessmcnt. "lhese deliberations rarely include representatives from independent scientific 

organizations or public interest organizJtions, and government ollicia!s are typio!ly a 

small minority of participants in comparison w ,;dentists employed or largely funded by 

chemical rn:mufacrurers. Although rhcir industry sponsors claim that such efforts represent 

"partnerships" that are balanced and therefore persuasive, in fact the limited number of 

participating government scientists do not and cannot rehabilitate the credibility of these 

li.mdamentally biased discussions. 

TI1e Intern,ttion,d Life Sciences Institute (ILSI) ,md Toxicology Excellence fOr Risk 

Assessmcnr (TERA) are the most effective and active leader~ in this intensifying eHOrt ro 

convert industry rese;trch inro the result of an "industry/government partnership." Both 

are self-styled "tripartite" organizations £hat purport to represent a broad consensus among 

scientists from industry, government, and academia. ILSI ls primarily funded by large 

,tgribusine~s and TERA receives substanlial llnancial support from chemica! manufauurers 

and their cuswmcrs, Both firms arc structured as non-prof1t corporations. 1hey rarely 

produce their own research, but rather compile and assess the research performed by other 

industry-sponsored sciemists, 

For example, ILSI has a subsidiary, the Health and Environmental Sciences Institute (HESI), 

whicb has convened the "Risk Assessment in the 21st Century lCchnical Committee" 

(RISK21 ). Its purpose is to create and advocate ri.<.k assessment policies that would result in 

far more lenient conrro!s on toxic chemicals by federal and state regulators. Simltarly, when 

.<.tate rcgu!arors in Wisconsin began to consider limits on the chemical byproducts produced 

wben two widdy used herbicides break d0wn in the environment, the manufacturers of the 

herbicides hired TERA to convene an expert panel to develop a "reference dose" (RfD) for 

the chemicals. (An Rffi is an estimate of the daily oral exposure to a chemical that wi!! not 

result in adverse health effi-:cts.6

) "The result was an ankle co-authored with government 

scientists rhar advocued drinking-water limits up to 280 times higher than. the limit 

\Visconsin regulators had set. 

Government scientists have a commendable interest in developing their professional skills 

and judgment hy panicipating in scientific dialogues sponsored by rbe private sector. 1hey 

make mistakes when they lend their names to industry-sponsored articles or committee 

deliberations designed to influence regulawry policy, Not only do such activities undermine 

the independence of their government employer~, they undermine public confidence in 

regulatory agencies. Oisd:dmers to the eHCct that a governmrm scie'ntlst is speaking in her 

"pcrsonJl" Clpadry do little ro restore public conAdence. 
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Empirical Evidence of Industry Bias 

Because industry-generated science is so inAuentia! with respect to public policy, researchers 

have conducted empirical fCVie\VS to determine the CX(Cilt (0 which a ptojen's runding 

source influences its OUtCome. rn10sc Studies rcve,tlcd that industry-sponsored fCSC.-lfth is 

significantly more likely to produce results that exonerate chc:mica!s and other products 

than studies funded by govcrnmem or other enlities. 1 ln addition to the survey of studies 

conducted in the biomedical field described above, the industry influence on scientihc 

re:;earch has been docurnemcd in research regarding second-hand smoke, nutrition, and 

chemical exposures. For instance, a study of review an ides about second-hand smoke 

found that 94 percent of articles .tuthored by rese,nchers affiliated with the tobacco 

industry determined chat rhe smoke posed no hca!ch risk. 8 A survey of articles regarding 

the potential health effects of the controversial chemical bispheno! A revealed that 94 of the 

104 government-funded .mtdics reported adverse effects at low doses bm none of the 11 

industry-funded studies did. 9 In the nutrition and food science arena, a review of articles 

regarding rhe risks and benefits of several beverages, including sofr drinks, found that studie'i 

funded by soda manuElcturers wen: four ro eight times more likely to reach conclusions that 

were favorable to the sponsors chan non-industry srudies. 10 An empirical analysis of studies 

concerning rhc health effects of several widely used toxic chemicals found tbar GO percent of 

studie~ conducted by non-industry ~cientisrs concluded rhat rhe chemicals were hazardous, 

bur only 14 percent of industry-sponsored studies arrived at the same conclusion. 11 

As these studies suggest, industry funding affecrs scientific omcomcs and thus suggests that 

there is substantial corporate control over the construction of these studies, including the 

methods, data collectkm, analysis, ~md publication of the study results. 12 Study sponsors 

arc even able to define rhlC scope of the research and methodology used in the lab ln order 

to minimize the po~sibi!ity that this work wilt uncover adverse dlectsY Sponsors may also 

reserve their amhority to rewrite the article or block its entirely. Policies that 

require author~ and organizations ro disclose conAkts critically important 

because they suggest how the users of such research should evaluate it, For instance, if a 

research article includes full disclosures of amhorship rights and responsibilities, cridca! 

readers can look for evidence that the researchers' sponsors used comracts or other 

mechanisms to establish conuol over ou1comes or messaging. 
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Center for PrOfllressiive Reform 

The Structure and Funding of ILSI and TERA 

ILSI is one of the oldest and most prominent organizations established by the chemical 

industry to inAuence scientific conclusions about agencies' risk assessment policies. Founded 

in 1978 by Coca-Cola, Pepsi Cob, General Foods, Kraft, and Procter & Gamble, fLSI 

focuses 011 science policy decisions rhat may affect rhc food, agriClllrurc, and pharmaceutical 

industries. ILSI's membership remains limited to large corporations active in the food 

and drug industries. 14 It is governed by a board of trustees, half of whom are drawn 

from member companies, including Coca-Cola, Monsanto, and other large international 

corporarions. 1

' ILSI functions as 1he parent organization fOr 14 worldwide branches that 

arc aC[ive in science policy in rhcir respective regions and a Research Foundation. ILSI also 

supervises its separately chartered sister organi?.ation, rhc Health and Environmcmal Sciences 

Institute (HESI). 

HESl organizes conferences and committees that pubiish reporrs on policies that run the 

gamut of risk asse~sment practice, from haz;ud identHlcarion to dose-response modeling 

ro exposure science. Represematives from the chemical industry chair many ofHESI's 

comminees. 16 Committee members include academics and even government scientists 

who work on rcgnbrory progrrtms that affC"ct lL.SI-HESI corporate fundersY 'lhe. HESIsponsored interactions benveen government scientists and the entities that they regulate 

occur oms ide of the established regulatory process, potentially giving regulated entities 

exceptional inAuence over government policies. Industry of(en daims that the products 

of these interactions represent a scientific "consensus" even when independent academic<> 

and .'>cientisrs from public interest organizations are conspicuously absent. 18 

In 2010 ILS[ North America brought in $3.4 million in revenue. HESI received another 

$3.5 million and lLSI itself received $3.2 million.~') CD, is financial information was drawn 

from publically available IRS documems that do not require, and thus did not provide, any 

information about which organizations provided the funding.) I LSI's lack of dear disclosure 

of funding sources is problematic because the" bulk of its funding presumably comes from its 

corporate members, which can lead to the sponsorship bias issues described above. 

TERA was founded in 1995 and primarily focuses on conducting risk assessments fOr its 

clients, which include chemical manufacturers, their customers, and a handful of government 

agencies. TFRA also operates the Al!iance for Risk Assessment (ARA), a closely related 

organization that has organized conferences and workshops regarding new risk assessment 

methods.-:~n ARA recendy convened a series of workshops ro address the suggestions 

the future of risk assessment the National Research Council made in its 2009 

(a.k.a. the "Silver Book")/ 1 

FPA and other government agencies are among sponsors that include chemical 

manufacturers and industry trade groups bur do nor include public interest groups 

or independent science organiz.ations. 22 
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TERA is governed by a ten-person board that includes industry representatives and 

academics. Directors serve three-year terms \Vith the exception of Michael Dourson, 

founder and president, who is a perpetual member of the board, Prior to founding TERA, 

Dr. Dourson spem 15 years at EPA where he worked on several taxies projects, including 

the creation of EPA's [megrared Risk Information System. Dr. Dourson has also worked 

with the National Academy of Sciences ::md is a member of both EPA's and California's 

science advisory boards. 

TERA had gross revenue of ahom $:2.4 million in 2010, 32 percent of which came directly 

from indusrry. 21 Government agencies, including EPA, the Food and Drug Administration, 

and the National [nsdtute for Occupational Safety and Hcalch accounted for approximately 

40 pt>rcent. "Non~proflr" sources, including the affiliated ARA, represemed approximately 

30 percent. 24 Those non-profir sources are often dependent upon chemical manufi1cturer 

support. For example, TERA convened a panel regarding the carcinogenicity of hexavalent 

chromium dw w<~s flmdcd by the non-pro(it Aerosp~ce Indusrries A~sociation (AlA). 

AIA is in turn funded by corporations that rely extensively on hexavalent chromium in 

their manufacturing, including Racing and Alcoa. AdditionaHy, at least some ofTERA's 

government funding has come nor from EPA or other agencies charged with protecting 

public health, hut from agencies !ike the Deparrrnent of Defense, which relies on toxic 

chemicals and has millions of dollars of poremi:J.Iliabilities arising out of those uses.-'5 

Two case studies of recent ILSI and TERA advocacy make clear the goals and implications 

of their advocacy of science policies that favor their corporate sponsors. 

5 
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6 CenterforPr·n<•r••••iveReform 

Alachlor, Acetochlor and the Weakening of 

State Protection 

A!achlor and acetoch!or arc popular herbicides used to control weeds on millions of acres 

of American farmland, panicu!.HI}' in corn, wheat, ,md soybean fidds. Both chemicals are 

banned in the European Union bur their use is on the rise in the United States because 

the broad!eaf weeds and grasses they target arc developing resistances to other herbic'ides.1

r, 

A!ach!or is rhe second most used herbicide in rhe United StatesY The resurgence of 

these chemicals, as well as their prevalence in the drinking water supplies of agricultural 

states, has led some state agencies to institute tighter regulations on the herbicides and 

the chemicals they become as they break down in the environment. While the states were 

developing improved safety standards to protect public health and the environment, Dow 

and Monsanto, the manufacturers of these chemicals, funded a panel of sciemists w review 

toxicological studies and derive their own ''.<.afc" levels of exposure. 

~!he panel was organized through TERA and included scientists employed by government 

agencies tasked with ensuring pesticide and herbicide saferyY 'The panel consisted 

of five TERA employees, including irs president and direcror, three governmenr sdenrisrs, 

and a profCssor. 'The governmenr scientisrs were from EPA, the Maine Department 

of Agriculture, and the California Environmental Protection Agency, while the professor 

was from the Universily of Florida. The represent.nives from Maine and EPA refused the 

travel expenses :.lnd honoraria offered byTERA.::o'' The University of Florida professor 

and represemarive from the California Environmental Protection Agency accepted 

the offered funds. 

In addition w being elfective herbicides, alachlor and acerochlor pose environmental 

and hnm<ln health hazards. Acute exposures, like those suffered by Elrmworkers who 

spread the chemicals or work in tbe lields after they h,we been applied, can cause skin 

and eye irritation. People who live near agricultural lands are similarly exposed because 

wind d!spt:rscs the herbicides bef()rc they arc absorbed into the soil or washed off into nearby 

\Vaterways that serve a5 sources of drinking water. Chronic exposure to the chemicals can 

lead to cancer or endocrine disruption. Scientists have linked long-term expo;;;ures to liver, 

kidney, and spleen damage. 1

" 

Roth chemic.ds are also toxic to ,mimals. Acewchlor, !Or instance, affects development cycles 

in aquatic species, resulting in accelerated metamorphosis in amphibians and changes in gene 

expression and brain f11ncrion of minnows. 11 Changes in the mortality oF species lower on 

the aquatic fOod chain can rapidly accelerate up the chain and disrup( entire ecosystems. 

Regulators 
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'TO make matrers worse, both acetochlor and alach!or break down into degradates that are 

also toxic co human health and the environment. 1hc degradares aladdor~ESA, alach!orw 

OXA, acetochlor-ESA, and acerochlor~OXA arc even more prevalent in \Vater supplies than 

their parent chemicals and are cause fOr significant concern fOr some scicnrists and regularors 

because of their poternia! health effects. A 1994 srudy of acetoch!or and :<.imilar herbicides in 

12 Midwestern states f{)Und ab.chlor-ESA in all 104 surface w;ner :;ample~ tested. 12 

1hat .'>ame study detccred aLKhlor-ESA in J.!most rwo thirds of groundwater :.amples. 

EPA has 5Ct some regulatory limits on abchor and acctoch!or, but it has also allowed new 

and increased uses oLtcetoch!or, and has decided nor to regubte their dcgrad,ucs. 'I11csc 

decisions at the feJerallcvd, along with the pervasiveness of the degradates in drinking water 

in agricultural stares and emerging research concerning toxicity and carcinogenicity of the 

parent chemicals, spurred Minnesota and Wisconsin to establish their own llmirs on some 

of the degradarcs. (Sec text bo:x). [n 2009, shortly after these states began regulating, 

TERA's subsidiary ARA organized a panel of_-;;cientists to review toxicological data and 

to derive their own reference doses for the chemicals. Monsanto and Dow 

direct financial support to the panel and also paid TERA for organizing the panel 

and raciltating the workshop. 

7 
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27172.811

The TERA pane! reviewed sever.tl swdies that suggested degradates pose serious health risks, 

including the Monsanto drinking water study that Wisconsin regulators used to set the 

state's standard for alach!or-ESA. However, the panel ultimately recommended Reference 

Doses (Rms) for alach!or-ESA and -OXA that were based on more recent studies conducted 

by Monsanro rhar administered rhe chemical in the anim,1!s' food. 'Ihe panel's rationale 

was that the more powerful adverse effects nodced in the drinking water swdy could be 

<~rtributed to dehydration. The panelists, as we !I as the industry authors of the drinking 

water studies, speculated that the animals were dehydrated because they found the dosed 

water unpalatable. 11 So, insread of the drinking-water swdies, the panelists used feedbased studies, including two conducted by Centra! Toxicology Laboratory, to recommend 

RIDs for acewch!or-ESA and -OXA. Using just these four industry-sponsored dietary 

studies, the TERA pand developed RfDs that would lead to drinking water standards 

significantly higher rhan those the states deemed adequately protective of human 

hea!rh. The p.:me! recommended RIDs o('5600ppb for alach!or-ESA ,md l400pph for both 

acetoch!or-ESA and -OXA. Wisconsin adopted a standard of20ppb for a!ach!or-ESA while 

Minnesota set standards for acetoch!or-ESA and -OXA at 300ppb and lOOppb, respccrivcly. 

-I he TERA panel's recommendations were published in Regu!tttory TOxicology and 

Pht1rnutcolog)', a journal wirh strong industry t!es. 1

'

1 

When EPA's standard RfD to drinking water conversion is applied to the panel's 

recommend,nions it becomes dear that tho;;e recommendarions Jre significantly less 

prorenlve of public health than the standards adopted by the states.,(, The panel's 

recommendation for alachlor-ESA, for instance, is 280 times higher than the standard 

Wiscon~in adopted. 

Co·opt Their Regulators 
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Center for Progressive Reform 

Drug licensing, pesticide registration, and toxic chemical regulation are shaped by the 

complex science of toxicological ri~k assessment. As just one example of the complications 

involved in the practice of risk asses~ment, scientists can use a variety of melhods to account 

for uncertainties when rhcy extrapolate chemicals' potential low-dose cffeccs on hum:1ns 

from high-dose studies conducted with animals. Depending on the method used, regulatory 

decisions about how best to protect the public can var;r widely. In order w addrcs.~ these 

sorts of problems and \virh an eye toward protecting human health, government risk assessors 

use standard assumptions and guidelines that they develop through public processes and 

with the advice of experts from academia, private industry, NGOs, and other government 

agencies. lUll has a history of trying to preempt government~driven policy development 

through establishment of its own "tripartite" committees. 

A recent example of an ILSl-HESI committee that is working to reshape Federal risk 

assessment policies by hui!ding close relationships with government scientists is the ongoing 

Risk Assessment in the 21st Century Technical Committee (RISK2l ). Highlighted by 

a well-attended conference in January 2011, RISK21 has brought together more than 

100 ~cientists and regulators, the majority of whom are representatives from the chemical 

industry;~~ RISK2l is co-chaired by Syngenta's principal sciemist and Dr. Alan Boob is, a 

professor at the Imperia! College London who was previously a member ofiLSI's board of 

rru:.tees and has authored numerous industry-sponsored articles. Pesticide Action Network 

Europe (PANE) extensively researched Dr. Boob is' publishing history and ties to ILSf, and 

concluded that he is dearly biased toward the chemical industry, staring: "Alan Boob is was 

chair of the ILSl bo.1rd of trnstees <~nd a fierce defender of industry\ agenda in his work.'· 1

s 

PANE further determined that a list of his "publications reads like a list ofiLSI opinions and 

ILSI meeting repons," which "gives the impression that lloobis is a ghost writer for ILSL" 19 

In addition to I 9 chemical manufacturers and affiliated organizations RISK21 participants 

include the Consumer Product Safety Commission, the Oepanment of Agriculture, the 

Environmental Protection Agency, the Food and Drug Administration, and the National 

Institutes ofHealth:'n RISK21 has four sub-learns working on agendas that are closely 

related to important and controversial areas in the development of risk assessment practice. 

The Exposure Science Sub~ team: Accurately determining the extem to which certain 

populations are exposed to toxic chemicals is of critical importance to both risk 

assessment and risk management, particularly in rerms of protecting those that might 

be more susceprib!c to toxic effects, such as children and the elderly. •the RISK21 

exposure team, led by a represemative from the National Institutes ofHea!rh working 

closely with a scientist from Ary.~ta, a large chemica! manutacrurer, works to characterize 

exposme to chemicals with an emphasis on "real-world" exposures and a "data-driven'' 

approach. An exclusive emphasis on existing exposures is minimally protective of 
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Center for Reform 

human health because it fails to account for potential new or unpredicted exposure 

scenar!os. 41 Choosing whose "real-world" exposures arc relevant to regulatory decisions 

is also an important exercise, given the problem of toxic hot spots near Superfund sires, 

power p!anrs, and chemical faci!irics. 

1he Dose-Response Sub-team: Dose-response science attempts to determine the 

rdarionship ben'veen exposme to <~ chemical and specific toxic erfCcrs. Most roxicologic<~l 

research involves dosing animals with a chemical, measuring the response, and rhen 

extrapolating from that data human-rdevant dose-response curves. "The relationship is 

governed by complex biological processes and is one of the most important aspects of 

risk ::~sscssment. The R!SK21 dosc:~responsc team, led by reprcsencativcs from Dow and 

University of Nebraska, aims to quantitatively incorporate dose-response information 

into risk assessments with a strong focus on mode of action ana!ysis." 2 Focusing solely 

on mode of action analysis has the potential to over-emphasize certain obvious chemica! 

effects in the body while losing sighr of the overall roxie effects caused by exposure and 

highly complex biological processes.41 

1he Integrated Evaluation Strategies Sub-team: "lmcgrated evaluation strategies" 

is a carch-a!l for HESI's push away from current risk assessment practices, including 

animal resting, and toward a heavy reliance on in 1Jitro testing and rapid assessments of 

individual chemicals. Other expert organizations, like the National Academics' National 

Research Council have acknowledged that the new techniques are not yet reliable and 

arc "at leasr a decade An EPA sciemist and a former Syngenta scientist lead 

rhe RISK21 team, is developing a framework that relies on new technologies for 

evaluating the toxicity of chemicals that is "more accurate and utilizes fewer resources 

than the current paradigm."4'i Forcing a reliance on these technologies to save time and 

resources would rcsulr in potentially drastic :1dvcrse dfecrs on human health and the 

environment because they can ovcrsimplif)' the bio!ogic,1! processes that are afh::cred by 

the chemicals' toxic effecrs.46 

1be Cumulative Risk Sub-team: One of the most important, and most frequently 

overlooked, aspects of risk assessment, cumulative risk science attempts to account 

for the wide variety of factors that contrihme to the toxic effects that result from 

chemica! exposure. The RJSK2 t team is led by scientists at ExxonMobi! and the 

University of Milan and focuses on creating a method for assessing health risks of 

combined exposures to multiple chemicals in the context of other strcssors. The 

RTSK2l team downp!ays scientists' ability to determine wherhcr multiple str('.~sors 

combine at levels relevant to humans. In contrast, the NAS recommends that EPA 

"draw on other approaches, including those from ecologic risk assessment and social 

epidemiology, co incorporate inrcracrions between chemical and nonchemical strcssors 

in assessments."" 7 Congress recognized the importance of cumulative exposures, 

requiring EPA tO consider cumulative risk when determining pesticide tolerances 

under the food Quality Protection Act."~ 
884 


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Center for Pr,oa,ressiive Reform 

$4na_ft'-,:we.>lti:J-, Daw, COlorado State 

Animal Alternatives in Errvironmental Risk Assessment 

Procter d~ Cmnble, ['Oreal 

Development ofMethods for a Tiered Approach to 

Asse..~ the Bioa(:cumulation of Chemicals 

Dow, USEl'A 

Biomarkers: ofNephrotoxidty 

Pfizrr, University, John Moon's 

HESI Project Committee on Imaging for Translatimlal 

Safety Assessment 

Duke Unittersh]!. (;L·,xoSmithK!ine 

"Ou! Relevance atu:l FoUow-Up of Positive Rellnh.:s in ln 

Vitro (IVGT) Testing 

SmwjL 

Evaluating Causality in Epidemioit-gk Studies 

Subcommittee 

Dm.u, USl:"PA 

Framewutks for Alternative Chemical A~e.'!isment and 

Scie~;;tion ot'Sa;fer, Sustainable Alternatives 

Dow 

HESl Application ofGenomics to Mcdtanism~Ba.'ied 

Risk Assessment 

Government scientists' panidpation in these committees and meetings allows HES[ 

to mJ.kc claims to scientihc consensus where none actually exists. Government scientists' 

involvement with HESI and its members is inappropriate because they arc engaging 

in potentially far~rcaching policy discussions without the public notice and transparency 

that would anend similar discussions if pursued according to the rules that exist to govern 

these kinds of interactions and protect the puhlic-for example, the Federal Advisory 

Committee Act, which places great emphasis on open meetings, public involvement, 

and reporting of committee activities,'·1 Because the interactions between government 

11 
885 


27172.815

12 Center for Reform 

scientists and industry representatives fostered by groups like ISLI-HESI and TERA-ARA 

before any Notice of Proposed Rulemaking, they are not recorded on any 

and are thus not made known to the public. Even more troubling is that government 

scicnrisrs, to the extent to which they arc inAuenccd by their interactions with industry 

in these pre-decisional discussions, may be unduly predisposed to favor industry during 

the actual rulemaking process. 

Recommendations 

"lhc Obama Administration has repeatedly reaffirmed its commitment to running a clean 

,md trilnsparent governmt•nt. President Ubama's 2009 scientific integrity memorandum 

state~ his aspirations for protecting government science from undue inAuences.'0 Shortly 

after its publication, EPA Administrator Lisa jackson published her own memorandum 

pledging tr,lnsp<lrency with respect 10 sciemihc analysis ,lt the AgencyY Unfortunately, the 

administration's initiatives have had mixed success. As this repon indicates, serious problems 

can occur when EPA sciemists interact with industry scientists in circumstances that industry 

spokespeople characterize as "partnerships" with government. Portraying such discussions 

a~ balanced collaboration appears to be an attempt to whitewash ends-oriented deliberations 

rhat havt• as their primary goal the weakening of controls on toxic chemicals. 

So that it can attract and retain the best scientists, the government should encourage agency 

scientists to particip;lte in events organized by private sector scienriflc organizations that 

do not attempt ro influence government policy in v·:ays that favor their industry financial 

supporters. Such events allow governm<.·nt sdentiS[S to remain current on the latest 

developments in research -and interact with ocher scientists in their field without exploiting 

their status as civil servants to make any recommendations seem less biased. For instance, 

the American Association for the Advancement of Science hosts a year!y forum on Science 

& Technology Policy.'' 

Chemical manufacturers have rakcn advantage of agency scientists' interest in professional 

development by fostering the growth of organizations like ILSI and TERA, which blur 

the lines between professional development and policy advocacy. ~or instance, after NAS 

published the Silver Book both ILSI and TERA set up committees (RISK2l, ARA's Beyond 

Science and Decisions) {0 p,lftncr with agency scientists in order to increase their inOuence 

over future federal agency risk assessment practice'S. Government scientist!.' participation in 

such activities undermines EPA's independence and objectivity. 

Govcrnmcm scientists need not rurn to industry and its affiliates for profCssion,ll 

development. Professional societies and organizations such as the American Association for 

the Advancement of Science provide numerous opportunities to engage with colleagues in 

rdev,mt fidds,'d And EPA policies designed to protect against individual bias on the part of 

agency employees should be revised w incorporate stronger protections againSt undue 

industry influence when agency employees arc pursuing professional development 

Regulators 
886 


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Guaranteeing Transparency, Eliminating Conflicts, 

Balancing for Bias 

1he federal Advisory Committee Act (FACA) sets out the basic legal framework that 

safeguards the integrity of federal agencies' consu!t,uion wirh outside experts.'' FACA's 

findings declare tkH "the public should he kept infOrmed with respect to ... [the] purpose, 

membership, {and] activitics."'1

' Although FACA only applies to committees established or 

controlled by government agencies, the principles it sets fonh indicate the huge gap between 

what can rightly be called a co!bboration among stakeholders and the biased processes that 

fLSI and TER:\ sponsor. 1hose principles include: 

Committee membership muM be balanced for bias, taking into account "a cross-section 

of those directly affccced, interes{ed, and qualified, as appropriate to the nature and 

funnion of the advisory committet'."'" 

Before accepting appoimment, potential committee members should fully disclose their 

other aiO!iarions.'·~ 

FACA committee members are subjccr to fCdcral ethics and conAict of interest laws.'') 

Committee meetings must be open to the public. 

The National Academics endorse simiLu principks in the rules governing their committees.M 

"!he internatiom! healrh community has ;1\so rakcn steps to preserve the integrity of irs 

comminee deliberations. The World Health Organization (WHO) requires disclosnres to 

be made befOre scientists can participate in meetings and places great emphasis on disclosing 

the rdarionship benveen the administrative unit or organization with which a scientist 

is interacting and any commercial entities.1

" \Vl10 committees foster transparency by 

inviting neutral outside scientists to observe the committct~ proceedings. WHO also requires 

disclosures to be made bcrore sdemists can participate in advisory meetings, including "any 

interests chat could constitute a md, potential or apparmt conAict of interest, with res peer 

to his/her involvement in the meeting or work, between a) commercial entities and the 

participant personally, and b) commercial entities and the administrative unit with wbich 

the participant has an employment relationship." (emphasis added)!·~ The stipulation tbat 

scientists must avoid potential or apparent conAicts of imercsr is critical. The I LSI and 

TERA activities described above do not meet this appropriately rigorous standard, much less 

the threshold requirements of balancing advisory panels ror hias and conducting comminee 

ddiberations in public. 

13 
887 


27172.817

We urge EPA and 

co!L1bomtions tbt 

to take .qeps to pur an immedbte end ro these 

industry and undermine uust in government. Specifically: 

EPA and other government agencies should withdraw their employees from 

participation in activities sponsored hy ILSI and TERA immediately. 

Government agencies should adopt ethics rules dut: 

Prohibit government scientists from co-authoring articles with industry-sponsored 

experts regarding matters that may be considered by their re~pective agencies, 

including individual toxicological risk assessments; 

Prohibit ~overnmem employees from participating in private sector activities that 

are designed ro influence a decision under the jurisdiction of the employer agency if 

such expcrr wil! be- aske-d to endorse the final work product produced by the group. 

Government agencies should estabtish programs to ensure that these ethics standards are 

heing met, including review by tr<~incd ethics orflcers of individual requests to undenake 

extracurricubr activities; limits on the time spent on such activities; and affirmarivc 

recommendations regarding appropriate private sector organizations. In formulating 

lisrs of qualified organizations, a~encies should rake inro consideration srandards for 

balance, transparency, and conAict of interest used by professional societies when they 

accredit entities that provide continuing education ln their respective fidds. 

Regulators 
888 


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15 

).de \lrink1ng \V,!ter Acr, 42 U.S.C ~ j()llg·l(l>)(5}(A)(i) 

t< M 

l' !d 
889 


27172.819

23 x .2"' 5.6 mgliH~·r or )600pph 

fPA. 2012. Fditwn of!ht Dnnbng W'acer St.md.mh ,1nd H~·.1hh Adviotll1<:'>. 

04 NAS, Sc!<:nc~ Jnd DcctSIOil> (St!vtr Book), .11 !i 

''" !rl 

"" Food Qu-1hry Prot~cwmAct of]')<)(), Public: bw 104-70. ~ 405. 

"'' f'e<kr.li Adl'hory CommtmT Act (fAC:A) of 1972, PublK Law 92·463. 'i U S.C 

App. Z 

1' Fcdnal:\dvJ.Iory Commmd: An. w;mt, now 49. 

'2 !d 

Regulators 
890 


27172.820

Rena Stein7.,Qr is a Proff.ssor of Law at the Universiry of Maryland 

School of Law, with a secondary appointment at the University 

ofiv1arybnd Medical Schoo! Department of Epidemiology and 

Preventive Medicine. Among the courses she teaches arc risk 

assessment, critical issues in law and science, and a survey of 

environmental law. Professor Steinzor received her B.A. from the 

University of\'V'isconsin and her J.D. from Columbia Law School. 

She joined the Maryland Etculty in 1994 from rhe Washington, D.C. 

Liw firm of Spiegel <llld McDi.trmid. From 198:3 to 1987, Steinzor 

\VJ.S stalf counsel ro the U.S. House of Representatives' Energy Jnd 

Commerce Committee's subcommirree with primary jurisdiction 

over the nation's laws regulating hanrdous substances. She is rhe 

President and a Director of the Center for Progressive Reform. 

Wayland Radin is a Policy Analyst at the Center for Progressive 

Reform, providing rc'>earch, drafting, coordination, and other staff 

assistance w CPR's Toxics and Clirmre Mitigation issue groups. 

Cozying Up: How the Manufacturers 

17 
891 


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To see more of CPR's work or to contribute, 

visit CPR's website at ww~rogreuivereform.org. 

455 Massachusetts Avenue, NW 

# 150-513 

Washington, DC 20001 

202-747-0698 (phone/fax) 

RETURN UNDELIVIRABLES TO: 

Center for Progressive Reform 

455 Massachusetts Avenue, NW 

# 150-513 

Washington, DC 20001 
892 


27172.822

September 29, 2017 

The Honorable John Barrasso 

Chair 

The Honorable Thomas Carper 

Ranking Member 

Committee on Environment and Public Works 

U.S. Senate 

Committee on Environment and Public Works 

U.S. Senate 

Washington, DC 20510 Washington, DC 20S10 

Dear Chairman Barrasso and Ranking Member Carper: 

On behalf of the undersigned organizations committed to improving maternal and child health across our Nation, we are 

writing to urge you to ensure the Director of the Environmental Protection Agency's Office of Chemical Safety and 

Pollution Prevention (OCSPP) vigorously upholds the mission of the office to protect individuals, families, and the 

environment from potential risks from pesticides and toxic chemicals. 1 

Our organizations are dedicated to the advancement of women's and children's health and improved health outcomes. 

The ideal outcome of pregnancy is not simply a healthy newborn, but a human being optimally programmed for health 

across the lifespan. Harmful chemicals can cross the placenta, and in some cases can accumulate in the fetus, resulting in 

disproportionate fetal exposure. Robust scientific evidence has emerged over the past several years demonstrating that 

preconception and prenatal environmental exposures can have a profound and lasting impact on health across the life 

course. In addition, as infants and children grow and mature, their unique physiologic, developmental, and behavioral 

differences make them especially vulnerable to chemical exposures during critical windows of development. 

It is with these concerns in mind that we propose the following joint principles that the Director of OCSPP should pledge to 

follow: 

Prioritize the protection of vulnerable populations, including pregnant women, infants, and children; 

Demonstrate an unimpeachable commitment to the health of the public over the interests of industry; 

Implement fully and promptly the Frank R. Lauten berg Chemical Safety for the 21" Century Act (Public Law No. 

114-182), consistent with congressional intent; and 

Defend existing pesticide and toxic chemical safety standards that protect the public health. 

The Director of OCSPP holds immense responsibility for the protection of the public's health. The Committee on 

Environment and Public Works has the duty of thoroughly vetting the nominee, and we encourage you to carefully 

evaluate the nominee to ensure his or her willingness and fitness to undertake and uphold the standards of the office. 

We hope that careful consideration will be given to our concerns, and that the health of vulnerable populations is 

uppermost during the nomination process. For any questions please contact Ami Gadhia, American Academy of Pediatrics, 

at agadhia@aap.org, Rachel Tetlow, American Congress of Obstetricians and Gynecologists, at rtetlow@acog.org. and 

Jaimie Vickery, March of Dimes, at ivickery@marchofdimes.org. 

Sincerely, 

y 

Fernando Stein, MD, FAAP 

President 

American Academy of Pediatrics 

Haywood L. Brown, MD, FACOG 

President 

American Congress of 

Obstetricians and Gynecologists 

Stacey D. Stewart 

President 

March of Dimes 

1 Environmental Protection Agency. About the Office of Chemical Safety and Pollution Prevention {OCSPP}. 

https://www.epa.gov/aboutepa/about-office-chemical-safety-and-oo!!ution~prevention~ocspp Accessed September 14,2017. 
893 


27172.823

Over 100 Organizations Across the US 

Oppose Michael Dourson for EPA 

October 3, 2017 

Dear Chairman Barrasso and Ranking Member Carper: 

On behalf of our millions of members and the American people, the undersigned 109 

organizations urge you to stand up for our health and environment by opposing the 

nomination of Dr. Michael Dourson for the position of Assistant Administrator for Chemical 

Safety and Pollution Prevention of the Environmental Protection Agency. 

The job of the Assistant Administrator is to lead the office whose mission is to protect 

American families and the environment from the potential risks of pesticides and toxic 

chemicals. This position will shape the way that the United States manages its 

environmental and chemical programs and thus will have a significant effect on the lives of 

millions of Americans. In particular, the next Assistant Administrator will be responsible for 

implementing and enforcing the laws designed to safeguard our health from toxic 

chemicals. This includes the Toxic Substances Control Act (TSCA), recently updated and 

amended by the Frank R. Lauten berg Chemical Safety for the 21st Century Act. The new law 

was signed on June 22, 2016 with the intention and hope that the updated requirements 

would be a beacon for change in the management of toxics and chemical safety. 

Implementation of the 2016 TSCA amendments is a significant and challenging task. It must 

be undertaken by someone who not only demonstrates through their actions and 

accomplishments a commitment to human and environmental health, but also by someone 

who is committed to implementing and enforcing the law as written without influence from 

the regulated industries that may have an interest in seeing the law weakened or poorly 

enforced. Dr. Dourson's background indicates that he is not the person for this job. 

Dr. Dourson's work consulting for the chemical industry during the last few decades raises 

significant concerns. First, he has a history of serving the interests of big business and 

industry dating back to the inception of the non-profit he founded and directed, Toxicology 

Excellence for Risk Assessment (TERA). Examples of TERA's questionable bias include: 

• In 1997, Dr. Dourson was hired by the Center for Indoor Air Research, which was 

later disbanded by a judge who found it to be a tool to bolster the credibility of 

tobacco products, to produce a report on the effects of secondhand smoke, which is 
894 


27172.824

known to cause cancer even in people who don't smoke. The report down played the 

effects by reporting that nonsmokers in the workplace have minimal exposures to 

secondhand smoke. 

• In 2002, DuPont sought out Dr. Dourson's firm TERA to recommend to West 

Virginia's Department of Environmental Protection a "safe" level for 

perfluorooctanoic acid (PFOA), a chemical made by DuPont and linked to cancer, 

thyroid disease, and obesity. His firm recommended a level that, as reported in The 

Intercept, was "150 times higher than the maximum safety level DuPont's own 

scientists had determined in 1988 -1 [part per billion] -based on internal 

company research showing that PFOA was toxic to both workers and lab animals." 

The EPA later conducted its own assessment which determined a level that was 

thousands of times more protective than TERA's recommended level. PFOA has also 

contaminated rivers and drinking water in Ohio, Michigan, New York, North Carolina, 

Pennsylvania, Vermont, West Virginia and other communities around the country. 

• An email revealed in The Intercept demonstrates how chemical companies hire Dr. 

Dourson to "bless" their dangerous chemicals: 

While everyone had a few names to offer, the common theme that 

emerged was that TERA (i.e. Mike Dourson) was the leading choice. TERA 

had "a very good reputation among the folks that are still in the business 

of blessing criteria," [DuPont employee Timothy] Bingman explained, going 

on to describe the company's ability to "assemble a package and then sell 

this to EPA, or whomever we desired." 

-"Trump's EPA Chemical Safety Nominee Was in the 'Business of Blessing' 

Pollution", The Intercept, July 21, 2017. 

• In 2013 Dr. Dourson was hired by Koch Industries to produce a study that found no 

adverse health effects to residents in Chicago who were concerned about piling 

amounts of petroleum coke (petcoke) from Koch subsidiary KCBX Terminals. Dr. 

Dourson's findings were based on soil studies and use of KCBX air monitors showing 

that petcoke soil is no different in the neighboring community than baseline levels in 

the rest of Chicago, and that the level of air contaminants are not likely to cause 

health effects. However, research by the city of Chicago and residents' own 

documentation of petcoke on their properties contradicted Dr. Dourson's findings. A 

class action lawsuit was ultimately settled for $1.4 million. 
895 


27172.825

• Dr. Dourson also published a report in 2014 entirely funded by a polluting company 

to study 1,4 dioxane, one of the first ten chemicals being reviewed under the revised 

TSCA by the office he has been nominated to lead. PPG Industries, responsible for 

discharging the chemical and contaminating Ohio's waterways, hired Dr. Dourson to 

publish a paper on the chemical. The paper argued for an acceptable level of 1,4 

dioxane that is 1,000 times higher than EPA's drinking water guidelines. The 

methodology Dr. Dourson used in his assessment of 1,4 dioxane was rejected by a 

panel convened by the state of Michigan. 

We are not only concerned about Dr. Dourson's ties to the chemical and tobacco industries, 

but by the role he played in presenting industry-biased science in a seemingly neutral 

manner to alleviate concerns about their products. For example, Dr. Dourson administered 

a website designed for parents called "Kids+ Chemical Safety" that minimized the concern 

of chemical risks using chemical industry talking points. Another example of down playing 

concerns about chemical risks includes the "Tox Topics" web page of the Toxicology 

Education Foundation, led by Dourson and funded by companies like Chevron, Exxon Mobil, 

3M, and the chemical industry's trade association. 

The importance of this job is best defined by the imperative to protect our health. This is 

made clear by tragic personal stories including the West Virginia residents who lost their 

drinking water due to the 2014 Elk River Spill; the parents in Flint, Ml worrying about the 

effects of the lead in their water on the IQ and brain development of their children; the 

farmworkers in Bakersfield, CA poisoned by chlorpyrifos; and the family of 18-year-old 

Jonathan Welch who died on the job from exposure to methylene chloride. Whether and 

how potentially dangerous chemicals enter the marketplace is a matter of life and death. 

We can't leave those decisions to someone with Dr. Dourson's history of close ties to the 

chemical industry. 

As organizations committed to the health of the American people, we are deeply concerned 

with the nomination of Dr. Dourson as the Assistant Administrator. 

We need and deserve an Assistant Administrator for EPA's toxics office who will put public 

health first, without favoring the industry that the office is charged with regulating. We 

urge you to oppose the nomination of Mr. Dourson and insist on a nominee with an 

unblemished record of defending the health of the American people from the hazards of 

toxic chemicals. 

Sincerely, 
896 


27172.826

5 Gyres 

Alaska Community Action on Taxies 

Alliance of Nurses for Healthy Environments 

As You Sow 

Asbestos Disease Awareness Organization 

Blue Green Alliance 

Breast Cancer Action 

Breast Cancer Prevention Partners 

Build A Better Planet 

Cape Fear River Watch 

Capital District Against Fracking 

Catskill Mountainkeeper 

Center for Environmental Health 

Center for Health, Environment & Justice 

Central California Environmental Justice 

Network 

Citizens' Environmental Coalition 

Clean and Healthy New York 

Clean Production Action 

Clean Water Action 

Clean Water Action California 

Clean Water Action Connecticut 

Clean Water Action Massachusetts 

Clean Water Action Minnesota 

ClimateMama 

Coalition for Clean Air 

Collaborative on Health and the 

Environment 

Coming Clean 

Com it Civico del Valle 

Communications Workers of America 

Community Food and Justice Coalition 

Conservation Minnesota 

Conservation Voters for Idaho 

Cook lnletkeeper 

Del Amo Action Committee 

Democracy Initiative 

Ea rthjustice 

Ecology Center 

Empire State Consumer Project 

Environmental Advocates of New York 

Environmental Health Strategy Center 

Environmental Justice and Health Alliance 

Environmental Working Group 

Farmworker Association of Florida 

Farmworker Justice 

Food & Water Watch 

Fresnans against Fracking 

Friends of the Earth 

Global Alliance for Incinerator Alternatives 

(GAIA) 

Grassroots Environmental Education 

Great Neck Breast Cancer Coalition 

Green Inside and Out 

Greenaction for Health and Environmental 

Justice 
897 


27172.827

Green Faith 

Greenpeace 

Headwater LLC 

Health Care Without Harm 

Health Professionals and Allied Employees 

Healthy Building Network 

Healthy Legacy Coalition 

Healthy Schools Network 

Hillsborough Clean Investment Coalition 

Hip Hop Caucus 

Huntington Breast Cancer ACTION Coalition, 

Inc 

International Center for Technology 

Assessment 

League of Conservation Voters 

Learning Disabilities Association of America 

Learning Disabilities Association of Georgia 

Learning Disabilities Association of Illinois 

Learning Disabilities Association of Maine 

Learning Disabilities Association of New 

Jersey 

Learning Disabilities Association of South 

Carolina 

Learning Disabilities Association of 

Tennessee 

Lenape Indian Tribe of Delaware 

Los Jardines Institute 

Marin City Parent Academy 

Natural Resources Defense Council 

NC Child 

Nontoxic Certified I Made Safe 

North Carolina Conservation Network 

Northwest Atlantic Marine Alliance 

Oregon Environmental Council 

Organize Florida 

People for Clean Air & Water of Kettleman 

City 

Pesticide Action Network 

Physicians for Social Responsibility 

PODER 

Safer Chemicals Healthy Families 

Safer States 

San Francisco Firefighters Cancer 

Prevention Foundation 

Science and Environmental Health Network 

Sierra Club 

Stupid Cancer, Inc. 

Texas Campaign for the Environment 

Texas Environmental Justice Advocacy 

Services (TEJAS) 

The Alliance for Appalachia 

The Environmental Justice Coalition for 

Water 

The Institute of Neurotoxicology and 

Neurological Disorders (INN D) 

The Progressive Hub, Saratoga 

Toxic-Free Future 

Toxics Action Center Campaigns 
898 


27172.828

Tri-County Watchdogs 

Tri-Valley CAREs 

United Steelworkers 

Utility Workers Union of America 

Vermont Conservation Voters 

Vermont Public Interest Research Group 

(VPIRG) 

WE ACT for Environmental Justice 

West Berkeley Alliance for Clean Air and 

Safe Jobs 

Women's Voices for the Earth 
899 


27172.829

Why signatories oppose Michael Dourson's nomination: 

"Dourson has a long history of working for the interests of the chemical industry rather than for 

the health of communities affected by devastating pollution from these industries. This is a 

clear conflict of interest with the important mission of EPA to protect the environment and 

public health. His nomination must be rejected." 

-Pamela Miller, Executive Director, Alaska Community Action on Toxics 

"The implementation of the updated TSCA rule will have health implications for years to come. 

We need a leader who will put public health first when addressing toxic chemicals and Mr. 

Dourson is not that leader. As nurses, we strongly oppose his nomination for Assistant 

Administrator." 

-Katie Huffllng, Executive Director, Alliance of Nurses for Healthy Environments 

"Dr. Dourson's work consulting for the chemical industry during the last few decades raises 

significant concerns. The job of the Assistant Administrator is to lead the office whose mission is 

to protect American families and the environment from the potential risks of pesticides and 

toxic chemicals. We are sure that there are more qualified candidates for this position." 

-Andrew Behar, CEO, As You Sow 

"Profoundly unqualified." 

-Unda Reinstein, President, Asbestos Disease Awareness Organization 

"Involuntary chemical exposures are linked to increased risk of breast cancer and other diseases 

and disorders. The OCSPP's mission is to protect the public 'from potential risks from pesticides 

and toxic chemicals' and 'prevent pollution before it begins'. Mr. Dourson's industry links 

threaten to undermine the use of ""sound science as a compass"" in pursuit of this mission and 

his track record shows he will put corporate profit before public health. Protect the safety of 

our food, air, and personal care and other consumer products by opposing Mr. Dourson's 

nomination and insisting on a nominee who will stand up for public health." 

-Karuna Jaggar, Executive Director, Breast Cancer Action 

"OCSPP must be led by an individual free from any conflict of interest with the chemical 

industry. Based on his record, Michael Dourson is not that person." 

-Jeanne Rizzo, R.N., President and CEO, Breast Cancer Prevention Partners 

"Dr. Dourson's ties to the chemical industry can pose a significant conflict of interest. His 

concerns should lie with the American people and their health and safety." 

Soledad Haren, CEO and Founder, Build A Better Planet 
900 


27172.830

"His history of downplaying the risks of chemicals in drinking water supplies. Testing currently 

shows 1,4 dioxane and several perfluorinated compounds in our *treated* drinking water." 

-Kemp Burdette, River keeper, Cape Fear River Watch 

"Corporate shill" 

-Collin Thomas, Co-Founder, Capital District Against Fracking 

"Michael Dourson's has a history of working for the chemical and tobacco industries to 

minimize the health risks of their products. With the EPA poised to finalize chemical safety rules 

for the next generation, the stakes are too high to install a leader compromised by the industry 

he is nominated to regulate." 

-Ansje Miller, Director of Policy and Partnerships, Center for Environmental Health 

"He has a strong conflict of interest because he has represented the chemical industry for years 

rather than the public health interests." 

-Barbara Warren, Executive Director, Citizens' Environmental Coalition 

"We represent 50,000 Californians who want the taxies program to help drive the development 

and use of safer materials to protect our people, our environment, and yes, our economy!" 

-Andria Ventura, Toxics Program Manager, Clean Water Action California 

"The Environmental Protection Agency should be that- an agency whose priority is protecting 

the environment, including the people who live in it, and its leadership and staff should be 

made up of people who embody that mission. Michael Dourson is the opposite. He has 

consistently worked with the chemical industry to ensure that regulations of chemicals are 

based on profit motives rather than environment and public health protection. He does not 

belong in the EPA." 

-Elizabeth Saunders, Massachusetts Director, Clean Water Action Massachusetts 

"He has multiple conflicts of interest." 

-Bill Magavem, Policy Director, Coalition for Clean Air 

"The American public needs someone who will put the health of all families and children before 

anything else. Michael Dourson is not the person for the job." 

-Karen Wang, Director, Collaborative on Health and the Environment 

"The American People need and deserve a true champion for their health and safety in the 

office of the EPA, not Michael Dourson, whom the regulated industry has paid time and again 

to undermine safer chemical policies and regulations, advances, which if adopted, lead us to 

stronger public health and environmental justice outcomes for all." 

-Judith Robinson, Executive Director, Coming Clean 
901 


27172.831

"Community Food and Justice Coalition believes we need advocates working on behalf of 

communities and not industry." 

-Y. Armando Nieto, Executive Director, Community Food and Justice Coalition 

"He's a chemical industry lackey." 

-Bob Shavelson, lnletkeeper, Cook lnletkeeper 

"Industry ties. A person in that position should be a scientist and completely independent of 

any industry ties." 

-Judy Braiman, President, Empire state Consumer Project 

"He appears to be a nominee that will put public health at risk." 

-Peter M.lwanowlcz, Executive Director, Environmental Advocates of New York 

"Communities living on the frontlines of chemical hazards become even more susceptible to 

toxins when natural and human-made disasters strike. When we look at Dourson's nomination 

from environmental justice and chemical security perspectives, it's even more clear that the 

Trump Administration is prioritizing industry profits over health and safety." 

-Michele Roberts, Co-Director, Environmental Justice and Health Alliance 

"Farmworkers are among the most vulnerable people in our nation today. They are chronically 

exposed to toxic agricultural chemicals in the work place. Michael Dourson's record of denying 

the science and cozying up to industry is a threat to the health and safety of farmworkers, and 

ultimately, to us all." 

-Jeannie Economos, Pesticide Safety and Environmental Health Project Coordinator, Farmworker 

Association of Florida 

"Michael Dourson is the wrong person for any leadership position at the EPA since his career 

has been to minimize the true dangers of toxic chemicals in the service of those who 

manufacture and sell them. Even if he wanted to, he would be unable to change his orientation 

to firm control of the dangers from these chemicals." 

-Ronald J. Martin, Fresnans against Fracking 

"USEPA appointees should serve to strengthen the mission of the Offices they head. The 

appointment of Michael Dourson will weaken OCSPP and, as his track record has demonstrated, 

only serve the best interests of the chemical industry." 

Ahmina Maxey, U.S. & Canada Regional Coordinator, Global Alliance for Incinerator Alternatives (GAIA) 

"The EPA needs to be strengthened to protect public health and the environment from toxic 

pollution, not gutted to protect corporate toxic polluters." 

-Bradley Angel, Executive Director, Greenaction for Health and Environmental Justice 
902 


27172.832

"Mr. Dourson's track record suggests he is ethically compromised and inclined to represent 

chemical industry giants, rather than the public interest." 

-Charlie Cray, Senior Research Specialist, Green peace 

"We need impartiality and scientific leadership in this position. Allowing Michael Dourson to 

lead this program will put profits in front of scientifically-defensible common-sense health 

protections." 

-Eric Uram, Principal Consultant, Headwater LLC 

"We are deeply concerned that Mr Dourson has no interest in upholding this office's solemn 

duty. His history indicates that his priority is to undermine efforts to protect American families 

and the environment from the potential risks of pesticides and toxic chemicals." 

-Tom lent, Policy Director, Healthy Building Network 

"Michael Dourson is the wrong person for this job. He has demonstrated throughout his career 

that his focus is on protecting industry interests, rather than protecting human health and our 

environment." 

-Kathleen Schuler, Co-Director, Healthy Legacy Coalition 

"distorts the safety of chemicals" 

-Steven G. Gilbert, Director, The Institute of Neurotoxicology and Neurological Disorders (INN D) 

"Michael Dourson has a well-documented history of underestimating or ignoring risks to 

children's health from toxic chemicals. It's critical that we have someone leading the office of 

Chemical Safety who is on the side of our children and families, not on the side of polluting 

chemical industries." 

-Patricia Lillie, President, Learning Disabilities Association of America 

"Our toxic environment impacts the neurology of our citizens. This impacts the ability to learn 

and function on an optimum level. Therefore, Michael Dourson's relationship with and support 

of the tobacco and chemical industries proves his interest is not in the health and welfare of 

our families but in corporations that make their money at the cost of people's lives. As a 

support group for those suffering with learning disabilities and other mental health issues, we 

do not support his nomination." 

-Dr. Joan K. Teach, President, Learning Disabilities Association of Georgia 

"We must have someone who has a clear understanding of the dangers of toxins in our 

environment." 

-Bev Johns, President-Elect, Learning Disabilities Association of Illinois 
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"Michael Dourson has a history of supporting companies which produce and/or encourage toxic 

effects on our population. As a mother, grandmother and great-grandmother, I worry about the 

future generations. We need environmental PROTECTION, not DESTRUCTION!!!!" 

-Theresa Cavanaugh, lmm. Past-President, Learning Disabilities Association of New Jersey 

"As a member of a nationaiLDA coalition, the Healthy Children's Project, we have campaigns 

that advocate for the banning of toxic chemicals in products used by infants and children that 

may cause learning disabilities, attention deficit disorder, Autism, and other disorders. Mr. 

Dourson's background in the chemical industry would not be beneficial as we're trying to ban 

toxic chemicals, not just lower the 'acceptable' levels." 

-Anne Fogel, Co-Secretary, Learning Disabilities Association of South Carolina 

"He will not make the health of our children a priority." 

-Dr. JoyS. Marsh, State President, Learning Disabilities Association of Tennessee 

"We need someone who will protect our most vulnerable including children, low income and 

communities of color." 

-Tracy Gregoire, Healthy Children Project Coordinator, learning Disabilities Association of Maine 

"Dourson's record indicates that if he's confirmed as head of EPA's taxies program, 

communities already disproportionately impacted by toxins--particularly the millions of people 

living near chemical facilities--will face even greater risks to their health." 

-Sofia Martinez, Co-Director, Los Jardines Institute 

"The EPA is intended to protect the health and well-being of the general public and thus should 

not be staffed by people who have made a career of aligning with industry in a way that put 

profits ahead of people. The American people want and deserve better." 

-Amy Ziff, Founder & Executive Director, Nontoxic Certified/ Made Safe 

"Impact of pollutants on the marine environment and health of commercially fisheries is often 

underestimated. But we know it's really important to sustainable fisheries and ocean 

ecosystems. And who is responsible for this balance is really critical. Mr. Dourson's history of 

dismissing issues and facts tells us he is not the right choice for this job." 

-Niaz Darry, Coordinating Director, Northwest Atlantic Marine Alliance 

"21st century science reveals how critical the environment is to human health. Our well-being 

and our economy depend upon agency leadership that understands the true value of 

health-protective policy. Michael Dourson has not exhibited that leadership or understanding." 

-Jennifer Coleman, Director of Health Outreach, Oregon Environmental Council 
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"Corporate connections are inappropriate, undermine EPA's mission to protect health and the 

environment." 

-Kristin Schafer, Executive Director, Pesticide Action Network 

"Sounds like he's against regulation." 

-Sue Scherer, The Progressive Hub, Saratoga 

"Firefighters throughout the United States are faced with highly elevated rates of cancer to do 

toxic chemical exposures on the job. President Trump has said that he is a great supporter of 

first responders yet he has recommended an individual that has worked 'hand in hand' with the 

chemical industry down playing many of the toxic chemicals that are killing firefighters. The 

selection of Mr. Dourson is of extreme concern for the men and women of the entire 

firefighting profession. We cannot let this happen!" 

-Tony Stefani, President, San Francisco Firefighters Cancer Prevention Foundation 

"We oppose the nomination of Dr. Dourson to lead the toxic program at EPA. This is another 

example of the Trump Administration having the fox protect the henhouse." 

-A. nanna Scozzaro, Director, Gender Equity, Sierra Club 

"The cancer community at large- 80MM Americans strong- collectively demand that toxic 

chemicals in our food, air, water and everyday household products be regulated for safety." 

-Matthew Zachary, Chief Executive Officer, Stupid Cancer, Inc. 

"People who have worked for industries should not be running the government initiatives to 

police their former employers or clients." 

-Robin Schneider, Executive Director, Texas Campaign for the Environment 

"Generally speaking, there exist evidence on numerous pesticides and fertilizers used for 

agricultural farming in mid-western states that indicate fertilizers and pesticides get into the 

Mississippi River, as a result of run-offs, and drain into the Gulf, creating what is referred to as a 

'Dead Zone'. The science is there to proof those chemicals are causing and extending the dead 

zone, yet, like in this particular situation, the person being nominated, is not one we would 

stand by. His past record is a reflection of what we can expect, not reliable." 

-Juan Parras, Director, Texas Environmental Justice Advocacy Services {TEJAS) 

"Mr. Dourson is not a good choice. He has taken public policy positions on behalf of the very 

industries he will be regulating. The person in this role must protect the most vulnerable, not 

the companies who will profit from his decisions." 

-Laurie Valeriano, Executive Director, Toxic-Free Future 
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"Michael Dourson is a bad choice to run the taxies program because his track record of working 

for the chemical industry means that the fox will be guarding the henhouse when it comes to 

critical decisions with widespread impacts on the health of our communities." 

-Sylvia Broude, Executive Director, Taxies Action Center Campaigns 

"Dourson's ties to the chemical and tobacco industries and his past actions in support of those 

industries lead us to believe he will serve them and not the public health." 

-Katherine King, Secretary, Tri-County Watchdogs 

"Conflict of Interest" 

-Paul Mercurio, Recording Secretary, USW 

"Michael Dourson's support of the toxic chemical industry biases him against the public 

interest, intent of the law and the EPA mission, and our communities health." 

-Johanna de Graffenreid, Environmental Advocate, Vermont Public Interest Research Group (VPIRG) 

"Mr. Dourson has a history of manufacturing doubt and ignoring science. We need a leader who 

is willing to stand up against chemicals giants who bury facts in order to gain profit. We need a 

leader willing to put the health of the nation's vulnerable, our children, and our communities 

first." 

-Erin Switalski, Executive Director, Women's Voices for the Earth 
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NIGHTLY NEWS MEETTHE PRESS DATELiNE 

POLITICS CONGRESS WHITE HOUSE 

SHARE 

WASHINGTON Sens. Tom Udall, 0-N.M., and 

Richard Blumenthal, D-Conn., rallied chemical 

exposure victims and public health advocates on 

Tuesday to oppose President Donald Trump's 

nominee to become the nation's top chemical 

regulator. 

Michael Dourson. Trump's pick to lead the 

Environmental Protection Agency's chemical safety 

program, has sparked fierce opposition from 

Democrats and public health advocates lor spending 

decades producing industry-funded research that 

critics say downplays the health risks of chemical 

substances. 

"Instead of draining the swamp. [Trump] has filled up 

with some of the swampiest creatures ever And 

keeps getting scarier·- Michael Dourson might be the 

worst yet," Udall said. "Dr. Dourson has made a career 

of creating junk science for industry." 

"We need someone who's going to be a watchdog, not 

a lapdog for the special-interest chemical industry and 

other producers of contaminants and substances that 

can literally kill people, or stunt the growth of children, 

or make people sick," Blumenthal said. 

DEPAHTMENT NATIONAL SECUHITY 

9:46'()! P\1j 
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Democrats: Trump EPA Nominee Is Toxic Chemical Swamp Creature· \11-\C NC\\S 

U.S. Senators Tom Udall (D~ 

N.M.) held a press conference to 

oppose confirming Michael 

Dourson to lead the 

Environmental Protection 

Agency's (EPA) office, with 

victims and advocates alongside 

him, on Oct. 3, 2017 at the U.S. 

Capitol Suzy Khimm I NBC 

News 

Dourson, who is 

scheduled to appear 

before the Senate at his 

confirmation hearing on 

Wednesday, did not 

respond to a request for 

comment. The EPA has 

circulated praise for 

Dourson from others in 

the toxicology field. 

"Dr. Dourson is a highly 

qualified scientist, whO is 

a professor at the 

University of Cincinnati 

and the founder of a nonprofit," said EPA 

spokesperson Liz Bowman, citing his leadership 

positions and awards. 

Victims of chemical exposure and their family 

members shared personal stories of being exposed to 

substances that Dourson has helped the chemical 

industry defend, producing research that companies 

have used to argue for weaker regulations and 

oversight. 

Gwen Young's family lives in Hoosick Falls, New York, 

where a manufacturing plant contaminated the local 

drinking water with PFOA, a chemical that's been 

linked to cancer. Young, 12, said she has the highest 

PFOA levels in her blood among the children in her 

community. 

"I don't really feel safe anywhere I go," Young said. "I 

don't want this to have to happen to other kids. I don't 

think Michael Dourson is cut out to be in the position 

that he's nominated for." 

When DuPont was sued for PFOA exposure in West 

Virginia, the Dourson helped defend the company in 

court DuPont had previously hired Dourson's firm, 

https:!/v.'\vw.nbcne\vs.com!politics/congress/democrats·tnlmp-nominee-toxic-chemical~s\Vamp-crcature·n80728! [I 0/3/2017 9:46:0 I PMJ 
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Democrats: Trump EPA Nominee ls '!oxic Chemical Swamp Creature- NBC :-.;ews 

Toxicology Excellence for Risk Assessment, to 

establish a new exposure threshold. The level that 

Dourson's firm helped establish was 150 times higher 

than the level DuPont's own scientists had endorsed, 

and it was thousands of times higher than the level that 

EPA would ultimately set for drinking water in 2016. 

Sen. Tom Udal!, 0-N.M., leaves 

the Senate Democrats' weekly 

policy lunch in the Capitol on 

Sept 7, 2016. Bill Clark I CQ 

Roll Cal! via AP 

"We depend on the EPA, 

and specifically this 

position that (Dourson] 

would be filling, to 

protect us going 

forward," said Michael 

Hickey, another Hoosick 

Falls resident "We know 

that he won't be capable 

of doing that" Hickey's 

father died of kidney 

cancer after working at the Hoosick Falls plant that 

used PFOA, which is now a federal Superfund site. 

Without Republican support, Democrats do not have 

the votes in the Senate to stop Dourson from being 

confirmed. But they say that it's especially critical to 

bring attention to his nomination in light of the 

sweeping overhaul of the Toxic Substance Control Act, 

pointing out that the law passed with overwhelming 

bipartisan support in 2016. 

"Many people called it the most significant 

environmental law in 25 years to pass," Udall said. 

"Now when you have a good law, the most important 

thing is implementation. So do you want a guy that's a 

toxicologist for hire to be doing the implementation?" 

"'" 

SUZY KHIMM 

TOPIC CONGRESS 

FIRST PUBLISHED OCT 3 2017,6:15 PM ET 

https:i.".vww.nbcncws.com/politics/congrcssiJcmocrats-trump-nominec-to.l(ic-chcmica!-swamp-creature-n807281 [1 0/3/2017 9:46:01 PM] 
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Indiana motlwrs take fight over childhood cancer and chcm1cals to Washington D.C.- 13 lmestigates- 13 wnm Indianapolis 

Forecast Interactive Radar Traffic Watch Live Bob Kravitz 

Indiana mothers take fight over childhood 

cancer and chemicals to Washington D.C. 

SANDRA 

CHAPMAN 

J c 

PUBLISHED: OCT 3RD, 2017- 801PM (EDT) 

WASHINGTON D.C. (WTHR)- Mothers at the center of a 13 

Investigates report about childhood cancer are in Washington, D.C. 

speaking out about sick children in Johnson County and toxic 

chemicals. 

http:!/\vww.wthr.com/article/indiana-mothers-take-tight-over-chi!dhood-cancer-and-chemicals-to-washington-dc[l0/3/2017 9:43:38 PM) 
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NPQ Q -

Trump Nominee for EPA Chemical Safety Post Raises Ethics 

Concerns 

CONMY! September 26_ 

17 SHJfl:ES 

CC BY-SA. 3.0, Link 

September 20, 2017; Chicago Tribune 

One of the latest nominees to the U.S. Environmental Protection Agency is Michael Dourson, a 

nomination that is already raising considerable hackles in the science and environmental communities. 

Dourson, a toxicologist who once worked as a manager of an EPA lab that calculated the danger of 

chemical exposure, has been named to head the EPA's Office of Chemical Safety and Pollution 

Prevention. 

On the surface, Dourson would seem to be highly qualified. Dourson founded a nonprofit organization in 

1995, Toxicology Excellence for Risk Assessment (TERA), which tests and reports on whether chemicals 

are toxic and at what rate. The organization has 20 employees and a $2.5 million budget. Dourson's 

salary is paid jointly by TERAand the University of Cincinnati. But the nonprofit relies heavily on 

corporate contracts to fund its operations. 
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Dourson's past clients have included Koch Industries, Chevron, and Dow Chemical, and his work has 

been undeiWritten by trade and lobbying groups that produce pesticides and cigarettes, among others. 

Ethics experts have expressed concerns both about the nonprofit and Dourson's writings. For example, 

Sheldon Krimsky, from Thfts University said that "appointing Dourson to oversee EPA's chemical safety 

programs is part of a broader effort to undermine federal regulations protecting public health." 

"It is not even subtle," said Krimsky, who reviewed Dourson's recent publio;hed work. "He has chosen to be the voice of 

the r.hemical industry. His role as a scientist is simply the role of an industry-hired lav.')·cr-only to g-ive the best case for 

their client.'' 

For instance, Dourson and TERA produced three recent papers that said there were flaws in peerreviewed papers that showed a link between the use of the pesticide chlorpyrifos and delays in fetal 

development. The chemical is produced by Dow AgroSciences, a past client. Dourson and his coauthors 

declared that money did not influence their findings, but thanked Dow in a 2005 paper for its support of 

the study. The American Chemist!)' Council has stated support for Dourson's nomination. The trade 

organization has paid Dourson for scientific reviews. Their spokesperson, Jon Corley, said, "His 

knowledge, experience and leadership will strengthen EPA's processes for evaluating and incorporating 

high quality science into regulatozy decision making." 

Dourson has also been an unpaid consultant with Toxicology Forum and the Toxicology Education 

Foundation, two 501(c)(3)s whose primacy funders include the American Chemist!)' Council, oil 

companies, and the makers of food additives. If he is confilmed for the EPA, he has promised to end 

these affiliations. 

One of Dourson's largest accounts was for DuPont. The company was blanted for polluting a West 

Virginia tmm with toxic perfluoroctanoic acid, or PFOA Dourson's team determined in 2002 that PFOA 

levels of 150 ppb were safe, and the 188 private wells tested had a lower level. Dourson's findings were 

well above the 1 ppb that the internal findings at DuPont stated were safe. The EPA has since declared 

that only .05 percent of Dourson's acceptable level of 150ppb is actually safe. 

One DuPont executive praised Dourson's "ability to assemble a 'package' and then sell this to the EPA, or 

whomever we desired," according to an email cited in a 2013 legal claim by people who blamed exposure 

to the chemical for cancer, birth defects, and other health problems. 

It appears that the Trump administration has a practice of hiring people for agencies on the inside of the 

corresponding industzy. It also appears they often have views that are incompatible with the mission of 

the agency where they \vill be working. We have looked at some of the nominees and their ties to forprofit business here and here. Dourson's ethics filing for transition to a government position will likely 

be a long one.-Marian Conway 

ABOUT MARIAN CONWAY 
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I!Bil. 

Marian Conway, the executive director of the NY Community Bank Foundation, has a Masters in Interdisciplinary 

Studies, Writing and a Ph,D. in Public Policy, Nonprofit Management. She has discovered that her job and education 

have made her a popular person with nonprofits and a prime candidate for their boards. Marian keeps things in 

perspective, not allowing all that to go to her head, hut it is difficult to say no to a challenge, especially participating in 

change, in remaking a board. She is currently on eleven boards of various sizes and has learned to say no. 

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justice ~ystem as a form of restraint These off-label uses can have serious consequences on physical and mental health. 

What's Trending 
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Wlrrtqjmdmnitdanwia-, danEPA III'MIIEMWR 

Don't drink the water. That's something you'd expect to hear when you travel to a developing country. But that's 

what people are saying in Wilmington, a historic beach, tourist and retiree destination and the eighth~largest city in 

this state. It also happens to be one of my favorite places to go when I need a reprieve from the heat and humidity of 

central North Carolina. With its cham1ing historic rivetfront, shops, delicious restaurants, parks, water sports and 

beautiful beaches, it's a great place to relax and unwind. The last thing one should have to worry about is the safety 

of the local drinking water. 

Over the past couple of months, Wilmington residents have learned that DuPont and its spinoff company Chemours 

have been dumping unregulated chemicals into the Cape Fear River for decades and only recently stopped at the 

request of the governor. The result: Disturbing levels of chemicals like 1,4-dioxane, GenX and PFOA have been fotmd 

in the drinking water of residents in Wilmington, Brunswick and the surrounding area. 

These types of of chemicals, called fluorinated compounds, have been linked to cancer, thyroid disease and obesity. 

GenX and other fluorinated compounds are used in the making of Teflon, Scotchgard and other stain-resistant and 

water-repellant products. They are designed so that they are water- and oil-repellant, which means that they are 

extremely difficult to treat in water-treatment plants before they hit our taps. 

While GenX has received a lot of the attention, the chemical 1,4-dioxane -which is much more well-studied -has 

been fotmd in some places to be in excess of 3 5 parts per billion, a level at which, when consumed regularly over the 

course of a lifetime, cancer risk becomes two orders of magnitude higher than that at generally acceptable levels. 

Many Wilmington residents have been drinking this water their whole lives. Now they must worry about the risks to 

their and their children's health. 
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Breaking News 

Be the first to know'Mlen big ne'N5 breaks 

Wilmington has asked the EPA to start looking into GenX and investigating the safety of its water. But with asbestos 

denier Scott Pruitt and chemical industry representative Nancy Beck overseeing EPA's program in charge of 

regulating these chemicals, I don't have much faith in their investigation. Now, the Trump Administration has 

nominated Michael Dourson to lead the entire taxies program at the EPA. Will Mr. Dourson provide hope for 

Wilmington? 

A look at his background also leaves me skeptical. In 2002, DuPont hand-picked Dourson's firm Toxicology 

Excellence for Risk Assessment (TERA) to advise West Virginia's Department of Environmental Qp.ality on setting 

health levels for PFOA, one of the same chemicals now found in Wilmington's water. His finn came up with a level 

that was thousands of times less protective than a later EPA assessment. 1,4-dioxane is currently under review by the 

very office that Mr. Dourson has been nominated to lead. Yet he also published research on that chemical paid for 

entirely by PPG1 a company responsible for discharging this chemical and contaminating Ohio1

s waterways. 

Saturday, I went to a Rally for Clean Water in Wilmington to talk with residents about their concerns. They want 

what we all want- to know that when they open up the tap, they can drink the water without worrying about toxic 

chemicals. And they deserve better: corporate polluters that are held accountable for egregious pollution and 

government officials who will protect their health and safety at the local and the national level. 

ANSJE MILLER RESIDES !N HILLSBOROUGH Al'-iD IS THE D!Rf:CTOR OF POLJGT r1ND PARTNERSHIPS FOR THE Ct.N1'ER FOR ENVIRONMENTAL HEALTH. 
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E&E: Group outlines bias concerns over chemicals office pick 

https://www .eenews.net/greenwire/20 17/07/25/stories/1 060057872 

July 25,2017 

At least a quarter ofthe scientific papers by U.S. EPA's assistant administrator for toxic 

substances nominee were bankrolled exclusively by industry sources, according to a review by 

the Environmental Defense Fund. 

The public health advocacy group, which opposes Michael Dourson's nomination to lead the 

Office of Chemical Safety and Pollution Prevention, examined the funding sources for several 

dozen papers he authored or co-authored between 2005 and this year that were listed in the 

National Institutes of Health's biomedical database. 

Richard Denison, EDF's lead senior scientist, noted in a blog post yesterday that his estimate of 

Dourson's reliance on industry funding may be understated since about a quarter of the papers it 

reviewed didn't disclose who paid for them. And even studies that weren't solely financed by 

industry often included some money from chemical companies or involved "industry-affiliated 

participants," Denison wrote. 

In total, Dourson or his former company, Toxicology Excellence for Risk Assessment, were paid 

for their work on about three dozen chemicals by more than three dozen companies or trade 

associations, EDF found. 

Some of Dourson's notable industry-backed efforts include a study of petroleum coke for Koch 

Industries Inc., an examination of petroleum substances for the American Petroleum Institute, 

and two papers on chlorpyrifos for Dow AgroSciences LLC, which manufactures the pesticide. 

EPA has repeatedly found that chlorpyrifos is linked to brain damage in children, but 

Administrator Scott Pruitt earlier this year decided to keep the compound on the market while 

the agency conducts additional studies of it (Green wire, March 30). 

Dourson has also done work for industry on two chemicals- trichloroethylene (TCE) and I ,4-

Dioxane- that the chemical safety oftice he is poised to lead is currently reviewing. The 

Obama-era EPA also proposed banning the manufacture, import, processing and distribution of 

TCE, a known carcinogen, in degreasing and dry-cleaning operations- the compound's two 

primary uses in the United States (Greenwire, Dec. 7, 20 16). 
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The assistant administrator nominee's October 2016 TCE study said it was made possible by "a 

gift from the American Chemistry Council" but added that "the research hypotheses addressed, 

findings, and conclusions expressed in this paper are solely those of the authors and not 

necessarily those of supporting groups." 

Yet the study, published in the journal Regulatory Toxicology and Pharmacology, on whose 

editorial board Dourson sits, found that the safety range for TCE exposure was three to 30 times 

higher than the level recommended by EPA in 2014. 

EDF raised concerns about what Dourson's past work for industry means for the future ofthe 

Toxic Substances Control Act. With the support of industry, the law was reformed last year for 

the first time since it was enacted in 1976 by a bill named after the late Sen. Frank Lauten berg 

(D-N.J.). 

"In finally embracing TSCA reform, the chemical industry said it needed a neutral referee, an 

impartial arbiter of the many disputes over the safety of chemicals," Denison said. "Now with 

Dourson's nomination, any remaining semblance of impartiality and balance is gone." 

The EDF scientist added, "The chemical industry needs to be seriously asking itself: Is this any 

way to restore contidence in this country's chemical safety system?" 

EPA didn't immediately respond to a request for comment on the blog post. 

But the ACC defended Dourson's work and urged his confirmation."We believe his knowledge, 

experience and leadership will strengthen EPA's processes for evaluating and incorporating high 

quality science into regulatory decision making," ACC spokesman Jon Corley said in a 

statement. "The Senate should act on Dr. Dourson's nomination without delay as it comes during 

a crucial point in the implementation of the Lautenberg Chemical Safety Act." 
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TheScientist EXPLORING LIFE, INSPIRING INNOVATION 

News ~ Magazme Multimedia • Subjects · Surve~ Careers 

Nutshell 

Trump Nominates Toxicologist for Key 

EPA Position Michael Dourson, a former staffer at the Environmental Protection Agency, has controversial ties 

to industry. 

Sy Dian<~ Kwon I July 19,2017 

Whtte House announced thatPresidcntDonJ!d had rJDrnlnated 

to head the Environment<~ I Protection Agency Offke of Chem!C.a! 

Safety and Po1Jut1on Prevent1on. 

from a number of professors and 

expressed concern about Dourson's 

of Medicine:, worked at 

pr<Hse for the nominee 

"We are deep!y concerned ov<er the nommation of Michael Dourson to head the to"Xics office at EPA," 

RKhard Denison, lead senwr Scientist <lt the Envwonmental Defense Fund, an environmental 

this nommat10n fits the clear pattern of 

to posltmnsforwhlchtheyhavcslgnlflcant 

Adam Finkel, a dmica! professor of environmental health at the 

BLizzfeed that he ran mto disagreements w1th Dourson when they worked 

Popular Now 

Publishers' Legal Actic: 

Advances Against SciHub 

E!sev1era1 

the AMerican CMmica! SoC! 

calls to defend themSE'!ves. 

Researchers are piE'C!ng 

together the linksbetweent 

gutmicrobiomeandmental 

health. 

Sexual Touch Promote 

Early Puberty 

The brams and bodies ofy(J 

female rats can be acceler-il 

bythepresenu 

orbyst1mulat 

ofth<:!gemtals. 
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of r€comrner~dation from the 

the pair did 

overestimate!i 

email. 

Tags 

politics, pcHcv, EPA, Environmental Prutection Agency and Danafd Trump 

Add a Comment 

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By Robert Hueter 

By D1ana Kw on A proposal to do so would 

After Sunday's federal el1:!ctlon, 

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Nutshell 

& Op1mon 
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From Environment and En<>rgy Report 

Tum to the nation's most objective and informative dal!y enVironmental news resource to Jearn how the UnitE.."d States and key players 

around the world are responding to the environmentaL 

By Tiffany Stecker and Steve Gibb 

President Donald Trump's choice to head the EPA's chemical safety and pesticides office is 1Mnning praise from the 

American Chemistry Council and other industry groups, but some ex-agency officials say Michael Dourson's ties to Industry 

need to be scrutinized. 

Clndnnatl and founder 

After leaving the agency in 1995, he founded To>dcology Excellence for Risk Assessment (TEAA}, a regulatory and chemical 

rlsk analysis f~rm that becanm the Risk Sci-ence Center vvhen it joined with the University of Cincinnati ln 2015. 

'His knowledge, experience and leadership will 

on Dr. Pourson's nomination. IM.thout delay as 

Chemical Safety Act" 

And Jay· Vroom, president of the pesticide trade as_,ociation CropUle America, hailed the choice, 'We're delightad 1Mll1 the 

science and policy experience Dr. Dourson has under the induslrial chemical and pesticide laws," Vroom told Bloomberg 

BNA. 

he has the impat<iality and commitment to 

No information oos imrnedlatety awllable on when the Senate might receive begin considering Dourson's nomination. 

Rtsk Assessment Background 
923 


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Dourson was considered in 2014 to lead the EPA's Integrated Risk Information System, which identifies and characterizes 

chemicals' health hazards. The job went instead to Vincent Cogliano, then acting director of IRIS and currently an employee 

at the EPA. 

Oourson has published 'Nidely in the fields of environmental risk assessment by co~authoring more than 150 peer-revievved 

articles and has given more than 150 invited presentations, according to his biography on the University of Cincinnati's 

vvebsite. 

Most recently. Oourson served as a member of the EPA Science Advisory Board, where he chaired an ammonia chemical 

review panel. 

In 2014, the Center for Public Integrity and lnsideCiinnate News published an investigation of 1ERA, suggesting it worked 

closely with the chemical and tobacco industries to fast-track chemical risk assessments. Dourson said in response that the 

criticism didn't bother him: "We get criticized by everyone. But that doesn't change the fact that 1ERA is neutral." 

Oourson defended his decision to work 'Nith the tobacco industry. "Jesus hung out with prostitutes and tax collectors. He had 

dinner 'Nith them," he said, according to the investigation. "We're an independent group that does the best science for all 

these things. Why should we exclude anyone that needs help?" 

Vroom said h'1s organization has no doubts that Dourson could become acclimated to pesticide issues after a background in 

the industrial chemicals v.urld. 

''The same science and risk assessment principles apply to assessing pesticides," Vroom said. "Having a leader in place 

and the extra capacity that brings is what's important, and we commend the president and Administrator [Scott] Pruitt on this 

nomination." 

Unease Among NGO Community 

The Environmental Defense Fund is opposing the nomination, and farmworker groups are raising concerns about EPA 

decision-making and several 'NDrker protection rules that the taxies office oversees. 

"Farm'NDrkers face unique pesticide risks, and if confirmed, vve hope the EPA's taxies office under Dourson 'NOn't continue 

to delay the farfTIVoiOrker protection standard and certification of pesticide applicators rule," Virginia Ruiz, director of 

environmental and occupational health at FarJ111N0rker Justice, told Bloomberg BNA. The latter rule creates more 

standardized training and certification requirements for applicators. 

Officials at the Natural Resources Defense Council and Environmental Defense Fund said they plan to raise questions about 

what they caHed Dourson's failure to report his financial ties to the chemical industry. 

'·Unfortunately, this nomination fits the clear pattern of the Trump administration in appointing individuals to positions for 

which they have significant conflicts of interest," Richard Denison, senior scientist with the Environmental Defense Fund, 

said in a blog post 

Former EPA OffiCials 

Former EPA policy official and scientist Tracey Woodruff-now'N'ith the University of California-San Francisco-shared 

Denison's concern. She worked at EPA from 1997 to 2007 and echoed Sussman's emphasis on the importance of EPA 

properly implementing the overhaul of the Toxic Substances Control Act (TSCA). 

"Dourson's documented vvork with the industry could lead to a literal 'open for business' access to EPA decision making 

about toxic chemicals at a critical time of TSCA implementation," Woodruff said in an emaiL 

Sussman, who is a consultant to the advocacy group Safer Chemicals-Healthy Families, said the new TSCA "is at a critical 

stage right now." 

''We need someone at the helm 'Who 'Nil! provide leadership in addressing chemical risks, despite industry pressures to block 

action. Dourson's record raises questions Vvtlether he will provide that kind of leadership," Sussman said. 
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But William Jordan, 'Mlo served at the EPA beW.Ben 

cited Dourson's experience ln expressing hls support. 

2010 and reured as the deputy director of pesticide program, 

"Not only does he bring a llfetime of experience vvorklng on hurr.an hea!th risk assessrnont Issues, but he is familiar with 

EPA, serving ln the Office of Research & Development as 1.-vel! as in EPA's OffJce of Pesticide Programs:' Jordan 

said in an email. 

To contact the reporters on this story: Tiffany Stecker Washington at tstecker@bna.com; Steve Gibb at sgibb@bna.com 

To contact the editor responsible lor story: Rachael Daigle at rdaigle@bna.com 

Copyright© 2017 The Bureau of National Affairs, Inc. All Rights Reserved. 

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Tax & Al;counting News 

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HR & Payroll News 
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USATOOAY SlffiSCR1BfNOW 

·<oget''""""OOI'"~c,. 
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By SHFllA JV\PIAN a11d EIUC LfPTON 

WASHINGTON- The sd.entist nominated to head the fed~ra1 

government's chemiral regulatory program hac; much ofhis 

helping businesses fight restrictions on t1w use of potentially toxic 

compmmds in consumer goods. 

That record is expeded to figure prominently in ~.£Dllfi:r11li.ttkln 

~for the scientist, Mkhael L is too dosely 

tied to the chemical industry to be its chief regulator. 

The source of the concern h a con..'m!ting group that Mr. Dourson founded in 

1995, which has been paid hy ch(:'mical companies for research and reports 

that frequently downp1ayed the hea1th risks posed by their compounds. 

Four chemicals that are nearly ubiquitous in everyday products- lA.::. 
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~, 1-bromonropane trichloroethylene and c~-are now 

under review by agency regulators to determine whether they pose a threal 

to public health. If confirmed, Mr. Dourson would oversee the review of 

some chemicals produced by companies that his firm used to represent. 

Mr. Dourson, 65, worked for the Environmental Protection Agency from 

1980 to 1994, according to hi<> resume, starting as a staff toxicologist, 

preparing health assessments of various substances. He worked his way up 

over time, becoming chief of the pesticides and taxies team in 1989, 

supervising scientists who support the E.P .A.'s regulatory work. Mr. 

Dour son ultimately oversaw a team of scientists conducting risk assessments 

for the agency's offices of water, solid wastes and air quality. 

The follol'.·ing year he created a nonprofit consulting firm that became a line 

of first defense for companies facing health and safety challenges from the 

E.P.A. 

Mr. Dourson has a popular sideline as a writer of books that combine Bible 

stories with his views on scient--e. His series, "Evidence of Faith," is an 

examination of the intersection of evolution and hible history. 

At a time when the E.P .A. is in the early stages of putting in place Congress's 

2016 overhaul of the law governing toxic chemicals, Mr. Dourson's 

nomination to become the agency's assistant administrator for chemical 

safety has alarmed Democrats and some former E.P .A. officials. 

··or. Dourson's consL'>tent endorsement of chemical safety standards that not 

only match industry's views, but are also significantly less protective than 

E.P .A. and other regulators have recommended, rai'leS serious doubts about 

his ability to lead those efforts,'' said Senator Tom Carper, Dt!mocrat of 

Delaware, the ranking minority member on the panel that will assess Dr. 

Dourson's qualific.ations. "This is the first time anyone with suc.h clear and 

extensive ties to the chemical industry has been picked to regulate that 

industry." 

Neither Mr. Dour son nor the E.P .A. would C'Ommcnt on the criticisms of his 

industry ties. A notice on the E.P.A.'s website praises Mr. Dourson's 

achievements in toxicology and the quality of his research. Trade groups for 

the $8oo billion chemical industry are supportive of the nominee, Crop Life 

America, which lobbies for purveyors of pesticides, fungicides and 

rc:xicnticides, called Mr. Dourson "a perfect fit." 

"VVe welcome Dr. Damson's nomination," CropLife America~ 

~."His extensive experience in risk assessment and science, both in 

government and private sector make him a valuable addition to the office." 

The confrrmation hearing for Mr. Dourson and others had been scheduled for 

\Vednesday, but it has been postponed and a new date has not been set. 

Senator John Barrasso, Republican of Wyoming and chairman oft he Senate 

committee that will hold the hearing, defended Mr, Dourson's nomination. 

"Dr. Dourson is an experienced toxicologist who deserves full and fair 

committee consideration, followed by a Senate vote," Mr. Barrasso said. 

"That should be the case for all of the nominees for leadership roles at the 
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E.P.A." 

The nonprofit consulting firm that Mr. Dourson founded and ran, TERA, 

became part of the University of Cincinnati in July 2015. The department 

changed its name from the TERA Center to the Risk Science Center in 

,January 2017. The center disclosed that it collected about 30 nercent ofits 

funding from for~ profit sources in the 2015~16 fiscal year. 

Mr. Dourson's ethics agreement says that he will not, once confirmed, 

participate for one year in any "particular matter involving specific parties" 

related to University of Cincinnati work he has done. 

But Mr. Dourson's fmanrial disclosure report filed after he was nominated 

- shows no direct payments to him from any chemical company, meaning 

any company-funded research Mr. Dourson did in the last year would likely 

have been paid for through the University of Cincinnati or another 

organization. 

As a result, it is unlikely ethics rules would bar him from overse.eing issues 

related to chemicals manufactured by companie~ he has conducted research 

for. Grants given by companies to universities, but not to the scholars 

themselves, generally do not create conflicts that require individuals to 

recuse themselves from matters involving the companies, said Walter 

Shaub, the former head of the federal Office of Government Ethics. 

Mr. Dourson's firm's clients have included the American Chemistry Council, 

the industry's top lobbying group. The firm also advised individual 

companies, makers of flame retardants, compounds that are ca11ed 

"chemicals of concern," and pesticides. 

In some cases, his firm provided results that suggested the health risk of a 

certain chemical or product was less than the assessment by the E.P .A. and 

other researchers. 

PPG Industries, for example, a paint and coatings manufacturer, uses a 

chemical called 1,4-dioxane, which the E.P.A designated ''a likely 

carcinogen," in its products. The substance is also created incidentally in 

some shampoos, r..osmetic..'i and personal care products through chemical 

reactions. 

PPG hired Mr Dourson's group. which proposed establishing a safe level for 

1,4-dioxane that would allow 1,000 times more risk than the E.P.A's 

recommended level. 

Other clients have included~ which makes flame retardants; l2IDY. 

AgroSciences which makes the pesticide chlorpyrifos; Waste Management; 

and~- He has also helped DuPont defend a chemical called PFOA, 

used to make nonstick substances, from states, including West Virginia, that 

sued the company to clean up contaminated water. 

Each of the four chemicals has been associated with severe health issues, l-ike 

cancer, birth defects and developmental problems in children. Mr. Dourson's 

studies frequently concluded that the risk associated with these substances 

is much lower or more dubious than what E.P .A. scientists and independent 

researchers have found. 
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The most striking dis.crepancy between findings by the agency and his firm 

is likely Mr. Dourson's resean~h funded by Dow AgroSciences on the 

pesticide chlorpyrifos, in \\rhich the authors recommended a safe level that 

was actually 33 times higher than the agency's standard, according to an 

analysis by Richard Denison, lead senior scientist at the Environmental 

Defense Fund. 

The agency subsequently lowered its standard even more, to a level nearly 

6,ooo times less than Mr. Dourson's, according to Mr. Denis.on's analysis. 

E.P.A. scientists then recommended that the product be banned for 

commercial usc as a pesticide. 

But E.P .A. Administrator Scott Pruitt~ a staff recommendation for 

.a.h.:m, after objet.iions were raised by Dow and other industry players. 

More recently, Mr. Dourson published a report titled" A case study of 

potential human health impacts from petroleum coke transfer facilities," that 

was funded by Koch Industries, which has a subsidiary that handles 

petroleum coke and coal. The report concluded that human exposures, if 

any, ''arc well below levels that could be anticipated to produce adverse 

health effects in the general population." 

Adam Finkel executive director of the Penn Program on Regulation at the 

University of Pennsylvania Law School, who worked as a partner on a 

project with Mr. Dourson, said he observed a disturbing pattern. 

''Most of what he has done over time is to rush headlong to exonerate 

chemicals," Mr. Finkel said, adding that he stopped working with Mr. 

Dourson based on these concerns. 

"Pretty much every piece of work he's ever done, it just so happens that 

when they are finished with it, the risk is smaller than when they started, 

the doubt is larger, the concern is less." 

But Oliver Kroner, now a Cincinnati city environmental official, praised Mr. 

Dourson, with whom he worked at TERA for nearly 10 years. 

"I think Mike L'i widely misunderstood," Mr. Kroner said. "Here in chemical 

regulation, we're faced with a decision of whether we accept an the health 

science available to us, or if we exclude some science depending on the 

source." 

"Mike has worked hard to help strengthen the regulatory environment by 

improving the science coming out of industry and bringing a collaborative 

peer review approach to help assess the quality of industry-derived science," 

Mr. Kroner said. 

Three other E.P .A. nominees will be vetted at the confirmation hearing, one 

of whom also has spent much of his career defending businesses against the 

E.P.A.: William L. Wehrum, named to head the agency's Office of Air and 

Radiation. 

Mr. Wehrurn, who was acting assistant administrator for air and radiation 

from 2005 to 2007, is now a partner in Hunton & Williams, which has a large 

energy and environmental law practice. 
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In the past few years, Mr. Wehmm has represented the Rubber 

~'Ianufactnrers Association, the American Petroleum Institute, the American 

Forest & P.aper Association, and electric utilities, among others, against the 

E.P .A., legal records show. Mr, Wehrum did not return messages seeking 

comment. 

Liz Bovi'tnan, an KPA, spokeswoman, pointed to 1'1-ir. \<Vehrum's decadf's of 

working for the government and private sector as evidence of his 

qualifications for the new job. 

"Mr. \VE.'hrum·s career includes over years working in the environmental 

field through engineering, legal practice, and administrative duties," said Ms, 

BoV'.wan, \vho used to work for the Amc;ri~CJl.w.!lao:..CQUlliJL in a 

.'!tatemenL ''This addresses that directly." 

NEWS 

OPJNfON 

UVING 

LISTINGS &MORE 

SUBSCRIBE 
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- -

~- ~~"iF'~ ;;-" 

-_ -- - -=--- - __ - - =- - .::: _-- -- -=- - - - -

Mary Anne Hitt, Contributor 

D1rector of the Sierra Club Beyond Cool Cumpaign 

Meet The Four Horsemen Of The EPA-pocalypse 09!19!2017 01·34 pm ET I Updated Sep 19, 7017 

Every week, another declsion that endangers our families seems to come out of Scott Pruitt's and Donald Trump's 

Environmental Protection Agency (EPA). The latest facepalm/outrage comes in the form of confirmation hearings that start 

this vveek for four completely unacceptable nominees to critical leadership positions at EPA. 

This Wednesday, September 20, the Senate Committee on the Environment and Public Works Wll decide whether to 

confirm Bill Wehrum to lead the EPA's Office of Air and Radiation, David Ross as chief of the EPA's Office of Water, 

and Michael Dourson to head up the agency's chemical safety programs. Later this month, theywlll hold a hearing on 

the nomination of Andrew Wheeler as EPA's Deputy Administrator, the agency's second-in-command. 

We can thank EPA admlnistrator Scott Pruitt for these four horsemen of the EPA-pocalypse- four people who will gladly 

choose polluters over public health and clean air and water standards every time. 

Andrew Wheeler, vvho Pruitt has tapped for the number two spot at EPA, was descrlbed by the Washington Post as a 

"longtime coal lobbyist" and has worked on behalf of a company vvhich reportedly has numerous environmental and 

worker safety violations. Wheeler has spent his career challenging vital life-saving environmental protections that keep 

our air and water clean so that INe can keep our families safe(! vvrote this post about him earlier this summer). He also 

used to be an aide for outspoken climate-denying and corporate-polluter-loving senator, James lnhofe. 

Bill Wehrum, Pruitt's pick to head up the office in charge of enforcing the Oean Air Act and keeping your air safe to 

breathe, is a lobbyist vvho represents a host of coal, oil, gas, and chemical companies, and was a former George W. Bush-
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era EPA official. If you recognize his name, it's because he was also nominated to this position in 2006- his nomination 

was \Nithdravvn vvhen he failed to earn support of the 60 Senators needed for confirmation. 

And vvhile he's nominated to lead the EPA's air and radiation office, ironically enough, he's said that the Oean Air Act 

shouldn't apply to the carbon pollution that contributes to climate change and superstorms like Hurricane Harvey. As my 

friend John Walke at NRDC put it, Wehrum "is an industry la'hjler who was largely responsible for the Bush EPA's record 

of violating the Oean Air Act more often, and allowing more illegal emissions of harmful air pollution, than any EPA 

administration before or since." 

David Ross, nominated for for the top spot at the Office of Water, has sued the EPA many times related to its dean 

water safeguards in his work representing fossil fuel states like Wyoming, including challenging the Clean Water Rule and 

the Chesapeake Bay cleanup program (he lost the latter lawsuit, which the court called "long on swagger, but short on 

specificity"). According to E&E Nev.t.5, he "has represented states and industry in laVoJSuits against the agency- some of 

whiclh were filed by then-Oklahoma Attorney General and now EPA Administrator Scott Pruitt." 

Finally, Michael Dourson is on deck to head up the EPA division that oversees the chemical industry, called the Office 

of Chemical Safety and Pollution Prevention. According to the Environmental Defense Fund, "Dourson has extensive, 

longstanding ties to the chemical industry (as well as earlier ties to the tobacco industry). He also has a history of failing to 

appropriately address his confJ1cts of interest" The first example they cite hits dose to home for me as a West Virginian 

-they report he was the sole spokesperson for an expert panel studying the 2014 Elk River chemical spill but failed to 

disclose, until cornered by a reporter, that he had previously "done paid work for both of the companies that produced 

the chemicals involved in the spill." 

In addition, Dourson has spent much of his professional career writing studies that undermine existing science and 

concerns about toxic chemicals, and call for weaker regulations on chemicals like pesticides. As our friends at the .!d..oi!§.Q 

Farm Workers explain, Dourson was paid by Dow Agrosciences to downplay concerns about a toxic pesticide and cast 

doubt on a Columbia University study linking exposure to it by pregnant women to irreversible neurodevelopmental 

problems in children- in other v.rords, to hide the tact that the pesticide is dangerous to kids. As you may have heard, in 

a highly controversial move the EPA recently reversed restrictions on the use of this pesticide. called chlorpyrifos, shortly 

after meeting with officials from Dow. 

Senators shouldn't get fooled- Scott Pruitt has seized the EPA and is trying to install polluter lobbyists in key positions. 

We can't let dirty fuel lobbyists win- we need the Senate to draw the line and reject these nominations. 

M 0 R E : 

c~:s Newc \ '-------·---~ 

YouMayUke 
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USA TODAY S:USSCR!&N.OW 

~.;>Qa<hort"lctd.,y 
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By MICHAEL BIESECKER and JEFF HORWITZ 

Sep. 20.2017 

WASHINGTON (AP) -President Donald Trump's nominee to oversee chemical safety at the Environmental Protection Agency has 

for years accepted paymcms for criticizing studies that raised concerns about the safety of his clients' products, according to a te\·iew 

of financial records and his published work by The Associated Press. 

Michael L Dourson's nomination as head of EPA's Office of Chemical Safety and Pollution Prevention \Vas to be considered by a 

Senate committee Wednesday, but was postponed when the Senate adjourned early for the week. If confirmed, ethics experts said, 

Dourson's past vvritings and the money paid to him and a nonprofit he fOunded could represent potential conflicts of interest. 

'i'!"f.-ih!"f.· i!::::ontent 

strategy for the internet of things? 

Past corporate clients of Dourson and of a research group he ran include Dow Chemica1 Co., Koch Industries T nc. and Chevron 

Corp. His research has also been underwritten by industry trade and lobbying groups representing the makers of plastics, pesticides, 

processed foods and cigarettes. 

A toxicologist, Dourson worked at the EPA for more than a decade, leaving in 1994 as the manager at a lab that assessed the health 

risks of exposure to chemicals. The following year, he fOunded Toxicology Excellence for Risk Assessment, a private toxicity 

evaluation nonprofit organization that tes'ts chemicals and produces reports on which chemicals are hazardous in what quantities. 

Dourson's views toward industry arc I..'Onsistent \vith others Trump has selected as top federal regulators. Among them is EPA 

Administrator Scott Pruitt, who in March overruled the finding;; of his agency's O\Vll scientiStS to reverse an effort to ban 

chlorpyrifos, one of the nation's most widely l..JSed pesticides. 

Dourson and his organization previously worked under contract for Dow AgroScicnccs, the Dow subsidiary that makes chlorpyrifos. 

In tillee papers, Dourson and his colleagues pointed to what they said were flaws in pt.>er-revie\vcd srudies that linked delays in fetal 

development with even low lt'Vels of exp)sure to the pesticide, commonly sprayed on citrus fruits and apples. 

In a 2005 paper on the topic, Dourson and his co-authors thanked Dow for its support over a number of years to studych!orp)Tifos' 

toxicology and assess its risk and said that money in no,•.-ay influenced their findings t3voring the company's position. 
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Dourson did not immediately resp:>nd Tuesday to emails or phone messages seeking comment. 

Sheldon Krimsky, a Tufts University professor who srudies ethics in science and medicine, said appointing Dourson to oversee EPA's 

chemical safery programs is pan of a broader efforr to undermine federal regulations protecting public health. 

"It is not even subtle," said Krimsky, who revit"\.Ved Dourson's recent published work. "He has chosen to be the voice of the chemical 

industry. His role as a scientist is simply the role of an industry-hired lawyer only to give the best case for their client." 

In addition to its corporate clients, Douson's organization gets mom.")' from the U.S. and Canadian governments. In some instances, 

companies pay the group to evaluate a chemical and it organizes a scientific panel to validate the findings. 

According to the nonprofit's most recent publicly available IRS filing, Dourson was paid $131,000 for his work there in 2015. He 

separately earns $103,000 a year from the University of Cincinnati, where he holds a research fX>Sition. 

Dourson's pro-industry leanings were also evident in a now defunct website called "Kids+ Chemical Safety," which his group ran. 

The site, ·which described itself as a source of information about the safe use of chemicals around children, mirrored mlking points by 

chemical companies and rrade groups that financed Dourson's work. 

One 2016 article defended glycophospate, the active ingredient in Monsanto's RoundUp weedkiller, saying it was too early to start 

pointing fingers. One post assured parents that exposure to fire retardant chemicals in children's pajamas was too low to be a health 

risk. Dourson was paid S1o,ooo by the North American Flame Retardant Alliance, according to a financial disclosure form he flied 

with the Office Government Ethics. That group is a subsidiary of the American Chemistry Council, an industry trade group that has 

paid Dourson to conduct scientific reviews. 

Dourson's willingness to align his scientific opinions with those of his corporate patrons has earned him support from influential 

indusny groups now supporting his nomination. 

The American Chemistry Council said he would make an excellent addition at F.PA. 

"His knowledge, experience and leadership will srrengthen EPA's processes for evaluating and incorporating high quality science into 

regulatory decision making," said Jon Corley, the group's spokesman. 

Dourson has also served without pay for rw-o groups, the Toxicology Forum and the Toxicology Education Foundation, whose 

primary :ftmders include the American Chcmisrry Council, oil companies and the makers of food additives. He has resigned or 

promised to resign from these posts if confirmed for the EPA job. 

On the side, Dourson has also written three books seeking to reconcile his work as a scientist and a devoted Christian. His "lVidence 

of Faith" series seeks to align scientific knowledge with biblical accounts, such as how the Big Bang Theory could mesh with the Book 

of Genesis, whether the Shroud of Turin is real and whether evidence of the Nativit;r story can be found in the stars. 

Court records show Dourson and his work have often been called on when his corporate dicnts are seeking to fend off lawsuits, 

DuPont was accused of polluting a West Virginia town with Perfluorooctanoic acid, or P.FOA, a chemical that the company's internal 

tests had long ago concluded were toxic, Corporate officials discussed hiring Dourson as vart of a strategy to defend themselves. 

One DuPont executive praised Dourson's "abiliry to assemble a 'package' and then sell this to the EPA, or whomever we desired," 

according to an email cited in a 2013 legal claim by pt."'ple who blamed exposure to the chemical for cancer, birth defects and other 

health problems. 

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Dourson led a team that found in 2002 that PFOA levels up to 150 parts per billion were safe, a level higher than \vas found in testing 

of 188 private wells and springs. 

That was also well above the 1 part per billion Dupont's ovm scientists had concluded could be considered safe years before. The EPA 

now says that only 70 parts per trillion of PFOA arc acceptable- or only o.os percent of what Dourson's team said was safe. 

DuPont and a former subsidiary, Chemours Co., later paid $761 million to settle 3,550 lawsuits stemming from it.<> tL<;c of the 

chemical. 

Follow Associated Press reporters Michael Biesecker at http:/ltwitter.com/mbieseck and Jeff Honv:itz at htt.p·/ftwitter.com.(ieffhory.ritz 

Submit a confidential tip to The Associated Press at htt;ps:/fwww.ap.org.tips 

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WATCH LIVE TRUMP MAKES REMARKS ON TAX REFORM GET ALERTSml 

POUflCS >CONGRESS 

Wr!!TE J--K)USE JUSTICE PF!PAF!TMFMT N.AT!ONAL SECURITY 

EPA Pick With 

by SUZY KHIHM 

WASHINGTON-- President Donald Trump's plckto be the nation's top chemical 

regulator is expected to face tough questi-ons from Senate Democrats for spending 

decades working on behalf of corporations trying to stave off tougher chemica! 

regulations. 

Michael Dourson, \1\!ho's been nominated by the White House to lead the 

Environmental Protection Agency· s chemica! safety program, was slated to appear 

at a Senate cDntlmration hearing on Wednesday, but it was postponed on Tuesday, 

A new hearing date has not been announced. 

Senate Democrats have already expressed serious concerns about Dourson's 

long career of conducting industry-funded research, which ma}or manufacturers and 

!obb~Ang groups have use-d to downplay the effects of potentially toxic substances" 

"Dourson's work presents a disturbing track record of consistently daiming that 

these chemicals are much safer than independent scientists have determined," 

said Sen. Jeff Merkley, D-Ore. who's on the Senate committee thafs considering 

Dourson's nomination. 

Oourson wouid be leading that effort 

111e nomination comes at a pivotal 

moment for chemica! oversight Last 

year, Congress passed a major 

overhaul of the Toxic Substances 

Control Act for the first time in 40 

years. The new law is intended to 'fix 

serious shortcomings in the fed era! 

government's ability to regt~ate 

hazardous substances in everything 

from drinking water to household 

cleaning products. But the EPA 1s still 

in the earliest stages of implementing 

the new law, and, if confirmed. 

"It is imperative t~t we make sure EPA is up tn the task of implementing those 

critical reforms in a credible and objective way, and giving all Americans the 

protection and peace of mind they deserve," said Sen Tom Carper, 0-Det, the 

highest-ranking Democrat on the Senate committee for Environment and Public 
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Works. 

"Based on his record, rm not convinced Dr. Dourson is the right person for this 

importantjob," he added. 

At the heart of the controversy is Dourson's work for Toxicology Excellence for Risk 

Assessment (TERA), a non-profit he founded in 1995 to provide chemical risk 

assessments and other research on behalf of clients. Industry groups and private 

corporations sponsored one-third of the group's work in 2015. TERA has now 

folded into the University of Cincinnati, where Dourson currently works as a 

toxicologist. 

Asked about the criticism of Dourson's 

record, the Trump administration said 

that he was "receiving high accolades 

from experts across the country," 

according to Liz Bowman, an EPA 

spokesperson. She cited his 

leadership positions at the American 

Board of Toxicology, scientific journals, 

and the EPA, INhere Dourson worked 

from 1980 to 1994. Dourson did not 

respond to a request for comment. 

But criUcs argue that Dourson has 

consistently recommended standards 

for chemical exposure that are far 

weaker than what federal agencies 

have recommended, and that are 

highly favorable to the corporate 

interests that have funded his 

research. Dourson was paid by PPG, a major paint manufacturer, to examine the 

health efforts of 1 ,4-Dioxane, an industrial solvent that the EPA describes as "a 

likely human carcinogen." 

Dourson concluded that the safe level for exposure was 1 ,000 times higher than the 

EPA's recommendation, advocates from the Environmental Working Group 

pointed out in a recent report. 1 ,4-Dioxane is among the first 10 chemicals that the 

EPA have made a priority for risk assessments, as required under the 2016 

chemical safety law. 

Dourson has also published industry-funded research on two other chemicals that 

are on the fast track for the EPA review: Trichloroethylene, an industrial solvent 

linked to kidney and liver cancer, and 1-Bromopropane, a dry cleaning chemical 

that has been linked to reproductive and neurological problems, 

In addition to his research, Dourson 

has also served as an expert witness 

for companies being sued for toxic 

exposure and contamination. He was 

hired, for example, as a consultant for 

DuPont when the company was facing 

extensive litigation around PFOA, a 

chemical used to make Teflon that's 

been linked to cancer. Residents of 

West Virginia, where DuPont had 
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made TeTion for decades, sued the company, which settled in early 2017. 

"How does he put aside a 20-year career of being paid by the industry to do 

science in a way that favors their des! red outcomes?" asked Richard Denison of 

the Environmental Defense Fund. "He creates an aura of legitimacy around 

process that's fundamentally Gonnlcted." 

At his confinnation hearing, Senate Democrats are l1ke!yto push Dourson to 

explain !f and when he wou!d recuse himself from poiicymaking decisions at the 

EPA because of his work on behatf of industry. 

Sen. John Barrasso, R~Wyo., the chairman of the Senate committee on 

Environment and Public Works, defended Dourson as "an experienced toxicologist 

who deserves ful! and falr committee cons!der.ation. fo!bwed by a Senate vote." 

Barrasso also criticized Oemocmts for hokl!ng up consideration of other EPA 

nominees, stressing the importance of filling the agency's top positions. 

"Democrats muld rather play politics with nominations, than see po!!uters held 

accountable," he said. 

CORRECTION (Sept. 19, 2017, 6:33 p.m, En: An earlier version of tt1is articie 

misidentified the employer of Richard Denison, He works for the Environmental 

Defense Fund, not the Environmental Working Group. A 

SlJZY KHlMM 

TOPJC CONGRESS 

RRST PUBUSHED SEP PMFT 

+ NEXr STORY After He.afth Care Debacle, Tr.;mp Eyes Democr-ais for Tax Deai 

More to Explore 

An 18-year-old Saudi female is using her passion to change lives, 
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Trump's Pick for EPA Safety Chief Argued Kids Are Less Sensitive to Toxins 

MICHAEL DOURSON, THE toxicologistwhowillbethesubjectofa 

confirmation hearing on Wednesday for what many consider the second most 

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frump's Pick for EPA Safet} Chief Argued Kids Arc! css Sensitive to Toxins 

powerful post at the Environmental Protection Agency, has been hired by 

industry to consult on at least 30 of the chemicals he may be responsible for 

reviewing if he assumes office. 

Dourson's consulting company, Toxicology Excellence for Risk Assessment, 

or TERA, was paid by Dow Chemical, CropLife America, the American 

Chemistry Council, the American Petroleum Institute, Koch Industries, and 

other companies and industry groups to study dozens of chemicals. The 

evaluations TERA produced consistently failed to recognize threats that were 

clear to scientists and regulators not on the companies' payrolls. 

If confirmed as director of the EPA's Office of Chemical Safety and Pollution 

Prevention, Dourson will be in a position to set safety levels for many of the 

same chemicals his company was paid to defend, including nine pesticides 

scheduled for scrutiny and 20 industrial compounds that may be evaluated 

under the recently updated chemical safety law. 

Dourson would also be in a position to make decisions affecting chlorpyrifos, 

another pesticide he's been paid to research, which can cause memory, 

intelligence, attention, and motor problems in children. Based on numerous 

studies that found that very low doses of the pesticide can harm children's 

brains, the EPA proposed banning chlorpyrifos in 2016. In research paid for by 

Dow, the manufacturer of chlorpyrifos, Dourson came up with a safety 

threshold that was some 5,000 times less protective than what the EPA 

recommended for children between the ages of one and two. 

After reversing the proposed ban, EPA Administrator Scott Pruitt recently 

delayed the evaluation of both chlorpyrifos and other organophosphates, the 

chemical class to which it belongs, which had been scheduled to begin in 2017. 

Dourson would have input on the timing of those evaluations, as well as the 

research considered in them. About two dozen organophosphate pesticides are 

commercially available, all of which are neurotoxins. 

Environmental scientists have long recognized that children are especially 

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frump"s Pick for EPA SaJ~ty Chief Argued Kids 1\re Le~s Sensitive to To>.ins 

vulnerable to chemicals, including organophosphates, throughout their 

development. But in a 2002 paper paid for by the American Chemistry Council 

and the pesticide industry group Crop Life America, Dourson suggested that 

after six months, most children are no more sensitive to chemical toxicity than 

adults and that in some cases, they are even less sensitive. This idea places him 

well outside the scientific mainstream and suggests how he might approach not 

just these pesticides but all chemicals affecting children. 

Michael Dourson, nominated by President Donald frump to oversee the Environmental Pr•otection Agency~ s 

chemical safety programs, on Capitol Hill in W<Jshington, Sept, 14, 2G17. 

In addition to overseeing pesticides if confirmed, Dourson would be responsible 

for the implementation of the new Toxic Substances Control Act, which entails 

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f'rump·s Pick for EPA Safety Chief Argued Kid1. Arc Less Sensitive to Toxins 

setting safety levels for some of the most dangerous chemicals in use. As the 

2016 law required, the EPA has already chosen the first 10 substances to be 

evaluated. Of those 10, Dourson has been paid to work on three -

Trichloroethylene, 1-Bromopropane, and 1,4-Dioxane- and in each case, found 

them to be safer than independent scientists did. 

Often the standards TERA recommended weren't just off, they were wildly off. 

In the research commissioned by manufacturers of 1-Bromopropane, which the 

EPA is considering adding to its list of hazardous air pollutants, TERA put 

forward a safety level that was 67 times higher than one recommended by the 

National Institute for Occupational Safety and Health. For 1,4-Dioxane, a 

solvent that harms the liver, kidneys, and nervous system, TERA calculated a 

safety level that was 1,166 time less protective than that of the EPA. 

For PFOA, a chemical used to make nonstick products that has been found in 

the drinking water of 6.5 million Americans, Dourson helped West Virginia set a 

state safety standard in 2002 that was 150 times higher than an internal level 

DuPont itself had set years earlier and 7,500 time higher than the lowest 

standard set by a state. 

TERA consulted on another 17 worrisome chemicals- including lead, arsenic, 

and the carcinogens chromium and benzene - that the EPA has identified as 

needing further assessment as part of the Toxic Substances Control Act Work 

Plan. 

In 2015, Dourson and TERAjoined the University of Cincinnati and rebranded 

as the Risk Science Center. Since then, Dourson has co-authored at least one 

scientific paper with staff of the American Chemistry Council, Dow Chemical, 

and Exxon. 

Dourson and the EPA declined repeated requests to answer questions for this 

article. 

After Dourson's nomination was announced in July, the agency issued a press 

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fmmp's Pick for EPA Safety Chief Argued Kids r\rc: Less St!nsiti-vc: to Toxins 

release that cited "widespread praise" for the toxicologist from his colleagues. 

"Dr. Dourson has a can do and winning temperament that inspires confidence," 

said Gio Batta Gori, who, like Dourson, has consulted for tobacco companies. 

Chemical safety advocates say the overlap between Dourson's work and the 

chemicals under EPA scrutiny isn't surprising. "These companies aren't hiring 

Dourson if their product is hunky-dory," said Jack Pratt, chemicals campaign 

director for the Environmental Defense Fund. "He comes in when they've got a 

fire. Over and over, he's the guy that chemical companies hire when some 

regulator looks at their products and might potentially set a regulation." 

This coziness with industry has led environmental groups to wage a vocal 

campaign against Dourson, one offour nominees to high-level EPA positions 

being considered by the Senate's Environment and Public Works committee this 

week. 

"It's simply absurd that industry's go-to science-for-hire guy would now be 

charged with reviewing the safety of many of the same chemicals he's previously 

green washed," said Scott Faber, senior vice president of the Environmental 

Working Group, which has dubbed Dourson Mr. Pay to Spray. "It's like putting 

Philip Morris in charge of the American Lung Association." 

Patti Goldman, an attorney at Earthjustice, also strongly opposes his 

confirmation. But she has already begun focusing on how to limit the harm 

Dourson could cause if confirmed. "As someone who's been a scientist for hire, 

Dourson should recuse himselffrom decisions affecting chemicals he's worked 

on," said Goldman. "It's impossible for Dourson to be free of bias. What's he 

going to do, cite his own studies?" 

Top photo: A biplane crop dusts a wheat field with pesticide, in Palouse, Idaho, on July 28, 2816. 

D We depend on the support of readers like you to help keep our nonprofit 

newsroom strong and independent. Join Us -

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EPA toxics nominee provided Koch-funded study in Chicago petcoke battle: Midwest Energy \:ews 

EPA toxics 

nominee provided 

Koch-funded 

study in Chicago 

petcoke battle 

WRITTEN BY 

Kari Lydersen 

September 7, 2017 

Advocates concerned about pollution from 

petroleum coke are worried an Ohio 

professor's study down playing the risks 

http:/ /midwcstenergyne~vuom/20 17 /09/07/epa-toxi cs-nominee-provided-koch-fUnded-study-in-chi cago-petcoke-batt!ei[ l 0/3/20 17 2: 15 :4 4 p M] 
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EPA toxics nominee provided Koch-funded study in Chicago pctcokc battle I Mid\\CSt tnergy Ne\~S 

will gain new prominence now that he has 

been named to a key EPA post. 

In July President Trump announced his 

intent to nominate University of 

Cincinnati environmental health professor 

Michael Dourson to head the division of 

the Environmental Protection Agency 

responsible for chemical safety and 

enforcing the Toxic Substances Control 

Act. 

Environmental and consumer watchdogs 

quickly raised concerns about Dourson's 

history working for industry, authoring 

studies commissioned by DuPont, Dow 

and other chemical companies and the 

tobacco industry. 

Dourson was also hired by Koch 

Industries to study the health impacts of 

petroleum coke (petcoke) in Chicago, with 

his research starting soon after residents 

began raising concerns about the piles of 

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FPA toxics nominee prm,idcd Km:h-fundcd study in Chicago petcokc battle, Mid\\CS\ Energ} :\ews 

petcoke quickly growing at Koch 

subsidiary KCBX Terminals on the city's 

Southeast Side. 

The study, funded by Koch Industries and 

carried out by Dourson and two other 

scientists paid by Koch, found no risk of 

adverse health impacts from exposure to 

petcoke in the air or on surfaces in 

neighborhoods around KCBX's two 

petcoke transfer and storage facilities. 

One of those has since been closed, and 

the other one was forced by a city 

ordinance, following intense community 

pressure, to stop storing petcoke in the 

open. But residents are still concerned 

about petcoke escaping into the air and 

the Calumet River during the transfer 

process between barges and trains. 

And as they also fight other 

environmental battles, including around 

manganese contamination from a facility 

next to KCBX, Dourson's role in the 

petcoke battle underscores the odds 

residents are up against when fighting big 

business, especially with such an industryfriendly administration in the White 

House. 

"I'm not surprised that this person is 

being promoted. We've seen it happen on 

the national scale, we also see it on the 

local level," said Olga Bautista, a leader of 

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EPA to.~!CS nominee provided Koch·fundcd study in Chicago pctcoke battle: Midwest Energy NC\\S 

the Southeast Side Coalition to Ban 

Petcoke. 

"When you fall in line with these 

industries and people of power, you get 

rewarded and put in positions that have a 

lot of influence. And the people who are 

actually suffering from the pollution have 

very little recourse. They're calling the 

shots and deciding what is deemed 

dangerous and what is not deemed 

dangerous. When we try to speak for 

ourselves and defend ourselves, they say 

we are not experts." 

KCBX spokesman Jake Reint provided a 

statement about Dourson's work for the 

company, saying: "Dr. Dourson was one of 

several experts KCBX retained to make 

sure our bulk material terminals in 

Chicago were operating in compliance 

with all rules and regulations, and witb 

respect for the environment and our 

neighbors. This work included analysis of 

several years of air monitoring data and 

tests on more than 100 soil and surface 

samples collected from the neighborhoods 

near the KCBX terminals." 

Science in the service of 

industry 

The Environmental Defense Fund and 

Green peace USA are among the groups 

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EPA toxics nominee provided Koch-funded study in Chicago petcokc battle j Midwest Energy Ne\\S 

raising alarms about Dourson's ties to 

industry and urging Congress not to 

confirm his nomination when hearings 

are convened. 

Richard Denison, lead senior scientist for 

EDF, wrote in a blog post about Dourson's 

"extensive, longstanding financial ties to 

the chemical industry - an industry that, 

if he is confirmed, he will be in charge of 

regulating. And not only does Dourson 

have these financial ties to the industry, 

he has made a career of helping industry 

play down concerns about chemicals." 

Denison said that a review of Dourson's 

published papers between 2005 and 2017 

showed half of those where funding 

sources were revealed were fully funded 

by industry, and most were at least 

partially funded by industry. These 

studies covered controversial pesticides 

and other chemicals that are currently 

undergoing EPA review and which 

Dourson if confirmed would be in charge 

of regulating. 

After Trump's announcement, The 

Intercept published a chronicle of how 

Dourson's work for DuPont helped the 

company avoid providing clean water to 

West Virginia residents after the 

company's chemicals used in making 

Teflon polluted local groundwater. 

DuPont later was found liable and ordered 

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EPA tox1cs nominee provided Koch· funded study in Chicago pctcoke battle: Mid\u:st Energy News 

to pay $1.6 million to a woman who 

developed kidney cancer linked to the 

contaminated water. 

Petcoke study 

Environmental groups say such a record 

casts doubt on all of Dourson's work, 

including the petcoke study in Chicago. 

"I certainly wouldn't trust any study he 

did on its face," said Charlie Cray, a 

research specialist for Greenpeace USA. 

"It doesn't mean all the work he's done is 

suspect or biased, but when it's 

underwritten by a company like Koch 

Industries I would be skeptical from the 

start." 

Dourson and his colleagues sought to 

monitor petcoke in the air around the 

facilities and accumulated in soil and on 

surfaces. 

Their paper notes that the only significant 

study to previously examine health 

impacts of petcoke exposure in humans 

involved Canadian petroleum workers and 

found an increased risk of lung cancer. 

But once smoking and asbestos exposure 

were accounted for among those workers, 

Dourson wrote, petcoke was not found to 

be a risk factor. 

Since human studies are lacking, Dourson 

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EPA toxics rwmmcc provided Koch~ funded study in Chicago petcokc battle. Midwest Lnergy :\C\\S 

used studies in rats to determine what 

levels of petcoke exposure could be 

considered harmful. Those studies 

showed no significant impacts from the 

chemicals in petcoke, including when 

petcoke was applied to rats' skin. 

Exposure to petcoke dust at certain levels 

was found to cause accumulation of 

petcoke in the lungs and lung 

inflammation in rats. 

In November 2013 and April 2014, 

Dourson's team gathered petcoke dust 

accumulated on surfaces in bus stops, 

parks and rights-of-way near the Chicago 

petcoke facilities. The study determined 

that chemical indicators of petcoke 

contamination in the soil and on surfaces 

were no different than baseline 

accumulation elsewhere in the city. 

Inhalation of particulate matter from 

petcoke has been the main health concern 

in the area. Particulate matter is known to 

cause cardiac, respiratory and other 

health problems regardless of the 

chemical makeup of the material. 

Dourson's study found that based on 

KCBX's on-site air monitors, the level of 

PM10 (particulate less than 10 microns in 

size) dispersed was not likely to cause 

health impacts. The study concluded that 

"estimated human exposures, if any, are 

well below levels that could be anticipated 

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EPA toxic~ nominee prm.ided Koch-funded study in Chicago petcoke battle· Midwest Encrg) ?'\ews 

to produce adverse health effects in the 

general population." 

James Brusslan, an attorney who 

represented residents in a class action 

lawsuit that ultimately resulted in a $1.4 

million settlement, disputed those results. 

He cited research commissioned by the 

city of Chicago and residents' own 

documentation of petcoke on their 

property. 

"CDM, an environmental expert retained 

by the city of Chicago, issued several 

reports which flatly disagreed with the 

conclusions by Dourson's colleagues and 

others hired by KCBX that KCBX's 

operations were having little impact on 

the neighborhood," Brusslan said. "CDM 

determined that KCBX's periphery fence 

line monitoring was inconclusive, that its 

bulk sample testing had no persuasive 

value and that any air modeling 

performed in the area was unpredictable. 

As residents could see with their own 

eyes, dust from KCBX's facility inundated 

the neighborhood for years." 

CDM's criticisms of Dourson's study 

include a finding that petcoke dust could 

migrate off the site into residential areas 

without being logged by the company's 

on-site air monitors, since it might settle 

on the ground and later be lifted into the 

air. CDM argued that Dourson's study did 

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l:PA toxics nominee provided Koch-funded stud) in Chicago pctcoke hattie, Midwest Fncrgy Nc\\s 

not involve monitors between the 

company fence-line and the nearest 

residences, and found that PM10 impacts 

on nearby neighborhoods could be 

"substantially greater" than Dourson 

allowed. 

Implications 

By the time Dourson's study was officially 

published in May 2016, KCBX had already 

been ordered to remove its open piles of 

petcoke and the class action lawsuit was 

being settled. Brusslan said that 

Dourson's co-author Lyle Chinkin was 

involved in the lawsuit proceedings. The 

study notes that Chinkin, along with 

Dourson and co-author David Macintosh, 

were "retained experts for litigation 

purposes" for Koch, and "Koch Industries 

was involved in the problem formulation 

phase of this research." 

Dipro Bhowrnik, a researcher for 

Green peace, analyzed Dourson's research 

record and related policy developments in 

different areas. He theorized that since 

Koch Industries was forced to stop storing 

petcoke in Chicago, and had previously 

been forced to stop storage in Detroit, the 

company may hope to use Dourson's 

findings to combat opposition in other 

cities or states where it seeks to store 

petcoke. 

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EPA toxics nominee provided Koch-funded study in Chicago petcokc battle, Mid\\CSt Energy :Sew~ 

"It builds that cache of research that 

absolves petcoke of health impacts, so in 

the next community that's impacted, the 

industry is protected," Bhowrnik said. 

Public health and environmental 

watchdog groups have long complained 

that studies funded by industry are 

entered into the public and legal record as 

independent research. 

KCBX portrayed Dourson's research this 

way, including in a statement the 

company made at the time of the class 

action lawsuit, saying that: "Independent 

laboratories also have conducted tests on 

more than 100 soil and surface samples 

from the neighborhoods near the terminal 

and found no evidence of coal or petcoke 

dust." 

Bautista noted that community residents 

have partnered with universities and nonprofit organizations to do their own data 

collection and studies, including using 

balloons for aerial mapping and 

systematic air testing. 

"We've been using DIY methods for 

collecting data since the onset of this 

problem, which was absolutely crucial in 

how far we've gotten," said Bautista. "We 

can be experts in these fields because 

we're the ones who are impacted the most, 

and we have the most to gain from having 

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this information available." 

FILED UNDER: 

NEWS 

Almost a year after Illinois enacted a sweeping 

energy hill, Chicago-area developers, 

advocates, and government agencies are 

hustling to prepare local communities to take 

full advantage of state incentives coming in the 

next few years. 
958 

Senator CARPER. Some of you have been in this room before, 

some of you several times. I joined this Committee almost 17 years 

ago, and I have sat through a lot of hearings. Senator Inhofe has 

sat through more. Our Chairman has sat through a bunch of them, 

too. 

This has been an extraordinary hearing. Extraordinary hearing. 

And these decisions that we are going to make, that you would 

make, if confirmed, are really life and death decisions. No question. 

And you have witnessed, in some cases, an outpouring of emotion, 

almost fear about what your service, not all of you, but some of 

you, what your service might lead to. 

And I just want to say, Dr. Dourson, I try to treat other people 

the way I want to be treated. I met with you, and I appreciate the 

time you spent with me, and I care about surrounding myself with 

people who have good mind, also a good heart, and there is no 

question you have a good mind. You are well educated. You are a 

scientist. You are smart. 

I think what we are hearing from the Senators on our side, there 

is a question about your heart. And I don’t mind people saying to 

me that they think I am dumb. I don’t like it, but what really hurts 

me is when they question my heart. And there are really serious 

questions about your heart. 

A woman named Maya Angelou, now deceased, a great poetess. 

She used to say these words. She used to say, people won’t remember what you said. People may not remember what you do or did. 

They will always remember how you made them feel. They will always remember how you made them feel. 

And honestly, some of the people in this audience here that have 

lived through exposure of materials that we are talking about, they 

are afraid. They are afraid. And they represent a lot of other people 

as well. And I am afraid what you said here today does not diminish those concerns or those fears. I just have to say that to you. 

Thanks very much. 

Mr. DOURSON. Thank you, Senator. 

Senator BARRASSO. Thank you, Senator Carper. 

Thanks to all of the members. 

I am going to submit for the record a final letter from Sean 

Alteri, who is the Director of Kentucky Division of Air Quality, 

stating that ‘‘Considering his education,’’ regarding Mr. Wehrum, 

‘‘his education and experience as a chemical engineer and environmental attorney, Mr. Wehrum will be well positioned to provide 

clear, concise director to address the many diverse, complex air 

quality issues.’’ He goes on to say, ‘‘As a study of the Clean Air Act, 

Mr. Wehrum’s knowledge and experience will greatly benefit EPA, 

State, and local air pollution control agencies.’’ 

Without objection, that will be submitted. 

[The referenced information follows:] 

959 


27172.656

MATIIIEW 0. BIMN 

-- CD 

ENERGY AND ENVIRONMENT CABINET 

DEPARTMENT FOR ENVIRONMENTAL PROTECTION 

Tile Honlll8ble Jobn Barrasso 

JOIISowtRIJol.uV,\RD 

FIWIKFORT, IWf!UCKY 40601 

Seplelllber 18, 2017 

Cbail1llllll. Senate Commiuee on Environment & Public Works 

410 Dirksen Senate Offic:e Building 

Washington, DC 2051().6175 

Dear Senator Barrasso, 

0tARLES0. SN .. VHLY 

--

Through Ibis letter, I am formally o~ring support for the aomillalion of Mr. William L 

Webrum as the Assistant Adminstrator of EPA's Office of Air and RadiatioiL Considering his 

education and experience as a chemical eagineer and an eovironmental attorney, Mr. Wehrum 

will be wdl-positioaed to provide clear, c:onc:ise diredion 10 acldfess the many diverse, complex 

air quality issues. As a studcat of the Oean Air Act, Mr. Wchrum's knowledge 8Dd experience 

wUI g!Wiy benefit EPA, state, and local air pollution control agencies. 

1be Kentucky Division for Air Quality supports Mr. Webtum's nomination 10 serve as 

the Assistant Admlnislrator of EPA's Office of Air and Radiation. We look forward 10 working 

wilh Mr. Wehrum 8Dd EPA's senior leadenbip to continue lhe great improvement of air quality 

in Kentucky and throughout our nation. 

Sincerely, 

~(I}~' Sean Alteri, Director 

Division for Air Quality 
960 

Senator BARRASSO. Finally, with regard to the Nuclear Regulatory Commission and the issues of NEPA and licensing, I find the 

position that the nominee today has taken deeply troubling and 

outside the mainstream. I think it is just tailor made to those looking to delay the NRC’s licensing process indefinitely and to stop 

nuclear energy production from going forward in the United States, 

and I believe we need all the sources of energy. 

Finally, Mr. Ranking Member, if no one else has questions today, 

members are going to be able to submit written follow up questions 

for the record. We will do it by the close of business on Friday. The 

nominees will then respond to those questions by the close of business Thursday, October 12th. 

So, I want to thank each of the nominees, commend you, and 

congratulate you on the nominations, and the hearing is adjourned. 

[Whereupon, at 12:58 a.m. the Committee was adjourned.] 

[Additional material submitted for the record follows:] 

961 


27172.881

FLORIDA 

September 19, 2017 

The Honorable John Barrasso 

Chairman, Environment and Public Works Committee 

United States Senate 

The Honorable Thomas Carper 

Ranking Member. Environment and Public Works Committee 

United States Senate 

4500 Biscayne Blvd. 

Suite 350 

Miami, FL 33137 

Tel: 305-371-6399 

www.fLaudubon.org 

RE: Appointment of Matthew Leopold as General Counsel, Environmental Protection Agency 

Dear Chairman Barrasso and Senator Carper, 

Please accept my comments as you consider the qualifications of Matthew Leopold for appointment as 

General Counsel, Environmental Protection Agency. I direct Florida's largest and most respected 

conservation organization and have worked with and observed Mr. Leopold over several years. He has a 

good legal mind, strong leadership skills, and knows how to work with different interests to bring 

resolution to complicated issues. 

During Mr. Leopold's tenure at the Florida Department of Environmental Protection, I worked closely 

with the department on resolution of Everglades water quality issues necessary to settle federal 

litigation. Being directly involved, I saw that the state was successful in negotiating with USEPA a plan 

that allowed agreement on and eventual legislative approval of a program called "Restoration 

Strategies'' to create remedies to meet Everglades water quality criterion. 

It was also during that work that Mr. Leopold approached me to encourage Audubon's involvement in 

the State of Florida's efforts to litigate a resolution to the ongoing conflict between Florida and Georgia 

on interstate water usc. l thought then. and continue to think, that the case and the State's involvement 

reOected strategic insight and ambition to deal with an extraordinary set of legal issues. 

l further gained respect for Mr. Leopold because he recognized that environment stakeholders had 

interests in common with the State and could be enlisted to help further Florida's case. Later, when Mr. 

Leopold was representing Florida in the case as a private attorney, he again encouraged our 

involvement, and Audubon became the lead on an amicus curiae brief that added considerable evidence 

to the State's case. 

When l heard that Mr. Leopold was being considered for the position of General Counsel at USEPA, I 

was glad to offer my enthusiastic support. The agency and nation are facing serious challenges as rules 

and programs evolve to meet changing circumstances and views on the role of government regulation. 

We need good lawyers at US EPA who understand the importance of bringing people together to solve 

problems. r urge approval of his appointment. 

Sincerely, 

v-~ \ c· 

Eric Draper 

Executive Director 
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1013/2017 Widespre;,d Pr;,isij for Matt leopold I U.S. EPA News Releases I US EPA 

We've made some changes to EPA.gov. If the infonnation you are looking 

for is not here, yo11 may be able to fmd it on the EPA Web Archive or the 

January 19,2017 Web Snapshot. 

News Releases from Headquarters > Office of the 

Administrator (AO) 

Widespread Praise for Matt Leopold 

Leopold Nominated as EPA General Counsel 

09102120!7 

Contact Information: 

(pre<sCu'epa.goy) 

WASHINGTON -Yesterday, President Donald J. Trump announced his intent to 

nominate Matt Leopold to serve as general counsel for the U.S. Environmental 

Protection Agency. Mr. Leopold previously served as general counsel for Florida 

Department of Environmental Protection from March 2013 to February 2015 and 

as an attorney for the United States Department of Justice Environment and 

Natural Resources Division from January 2007 to February 20!3. He is currently 

of counsel for Carlton Fields Jorden Burt, P.A. focusing on environment, energy, 

water law, and litigatio11. 

His nomination is receiving high accolades from environmental leaders 

acros51 the country: 

Mareo Rubio, United States senator: "Matt Leopold's experience and 

knowledge will serve EPA well, and I'm glad the president nominated a Floridian 

who understands the importance of our state's vast ecosystems to our economy 

and residents' quality of life." 

Pam Bondi, attorney general of Florida: "Matt Leopold was a gteat asset to the 

Florida Department of Environmental Protection and I look forward to him 

working together with my friend Scott Pruitt." 

Adam Putnam, Florida commissioner of agriculture: "I'm tlnilled to see 

another Floridian joining President Trump's Administration. After eight years of 

increased regulations and fees under President Obama, with little to nothing to 

show for it, I'm grateful for folks like Matt Leopold, who bring a wealth of 

expertise and experience to Washington, as well as a common sense approach to 

protecting our environment, while enabling our economy to grow and thrive." 

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10fJI2017 Widespread Praise for Matt Leopold 1 U,S. EPA News Releases 1 US EPA 

John Cruden, president-elect of the American College of Environmental 

Lawyers and Assistant Attorney General, Environment and Natural 

Resources Division, U.S. Department of Justice (1212014-112017): "Matt 

Leopold was a valued colleague of mine at the Department of Justice. He is 

committed to the rule of law and can be counted on to give sound and candid 

advice to EPA decision makers." 

Eric Draper, executive director, Florida Audubon: "He has a good legal mind, 

strong leadership skills and knows how to work with different interests to bring 

resolution to complicated issues. During Mr. Leopold's tenure at the Florida 

Department of Environmental Protection, I worked closely with the department 

on resolution of Everglades water quality issues necessary to settle federal 

litigation. Being directly involved, I saw that the state was successful in 

negotiating with USEPA a plan that allowed agreement on, and eventual 

legislative approval of, a plan called 'Restoration Strategies' to create remedies to 

meet Everglades water quality criterion." 

Eric Eikenberg, chief executive officer, The Everglades Foundation: "Few 

attorneys in America are as familiar with the legal issues- and imponance- of 

Everglades restoration as is Matt Leopold, and I heanily applaud his nomination 

to be the next general counsel of EPA. Our paths have crossed often in the 12 

years since I first met Matt. I respect him as an attorney and a person of integrity. 

He understands the importance of America's Everglades and the critical need for 

restoration. Matt will serve Florida and our nation well, and I look forward to 

working with him and EPA to ensure America's Everglades are protected and 

restored." 

Ethan Shenkman, EPA deputy general counsel (0512014-0112016) and DOJ 

deput}- assistant attorney general, Environment and Nntural Resources 

Division (0312010-0512014): "During the Obama Administration, I served in the 

DOJ environmental division and then a! EPA. During that time, I had the 

opportunity to work closely with Matt Leopold on a number of environmental 

issues, where we crafted creative and responsible legal solutions to protect the 

environment, especially relating to the State of Florida where Matt served as 

general counsel of the Florida Department of Environmental Protection. In 

addition to his legal acumen and broad knowledge of environmental law, J believe 

Matt's previous experience al.l a wc11-rcs.pcctcd career attomcy at ENRD witl serve 

him well should he be confim1cd, and will enable him to foster a productive 

working relationship with the talented and dedicated career staff in EPA's legal 

shop." 

Herschel Vinyard, co-chair, Gulf Coast Ecosystem Restoration Council; 

secretary, Florida Department of Environmental Protection (011201 1-

1212014): "The first thing that the nation will learn about Matt Leopold is his 

unassailable integrity. The second thing the nation will learn about Matt Leopold 

is his unwavering commitment to following the law. I have seen firsthand how he 

brings those two key traits to the table, applies common sense and arrives at the 

ideal solution to complex problems. Kudos to the Trump Administration and 

Administrator Pruitt for making this selection." 

LAST UPDATED ON SEPTEMBER 2, 2017 

https;//WrNW.epa.gov/newsre!eases/Widespread-pratse~matt-!eopold 212 
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10/312017 Widespread Prsise From Environmental OffiCials fo-r Davtd Ross j U.S, EPA News Releases I US EPA 

We've made some changes to EPA.gov. If the information you are looking 

for is not here, you may be able to find it on the EPA Web Archive or the 

.bnumy 19, 2017 Web Snapshot. 

News Releases from Headquarters > Office of the 

Administrator (AO) 

Widespread Praise From Environmental Officials 

for David Ross 

Ross Nominated to Head EPA Office of Water 

0~/02/2017 

Contact Jnfonnation: 

(press@ <aJJhl:lL'J 

WASHINGTON- President Donald J. Trump announced yesterday his intent to 

nominate David Ross to serve as assistant administrator for the U.S. 

Environmental Protection Agency's Office of Water. Mr. Ross currently serves as 

Wisconsin assistant attorney general and director of the Environmental Protection 

Unit for the Wisconsin Department of Justice. As Wisconsin assistant attorney 

general, he is responsible for managing the environmental litigation unit which 

prosecutes violations of state environmental and natural resources laws and 

defends administrative decisions and rules issued by the Wisconsin Department of 

Natural Resources. Mr. Ross previously served in the Wyoming Attorney 

General's Office from 2014-2016 as seni.or assistant attorney general and as a 

member of the Water and Natural Resources Division. 

His nomination is receiving bigh accolades from environmental leaders 

across the country: 

David Freudenthal, former governor of Wyoming: "Dave Ross is first and 

foremost an excellent, pragmatic lawyer. His private practice experience in DC 

combined with his service in two state environmental protection agencies make 

him uniquely qualified to implement America's nuanced structure of federal and 

state environmental protection." 

Missel Cabrera, director, Arizona Department of Environmental 

Quality: "Mr. Ross has exceptional credentials and experience for the role of 

Water Director. In addition, his views on cooperative federalism are exactly what 

is needed at US EPA." 

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1013/2017 Widespread Praise From Environmental Officials fOi David Ross 1 u.s, EPA News Releases I US EPA 

Carol Comer, director of the Missouri Department of Natural Resources: 

"The Missouri Department of Natural Resources would welcome the opportunity 

to work with Dave on our critical water issues. He has valuable experience with 

complex, multi-stale policy decisions, and he understands the infrastructure 

challenges and needs of states like Missouri that have a significant number of 

small communities." 

David Glatt, chief, North Dakota Department of Health, Environmental 

Health Section: "Mr. Ross exhibits an excellent understanding of western water 

issues and challenges faced by rural states and tribal nations. His knowledge and 

work experience coupled with his willingness to pursue a renewed approach to 

cooperative federalism make him an excellent candidate for the position." 

Elliott Laws, Crowell and Moring LLP, former assistant administrator of 

EPA's Office of Solid Waste (Clinton): "I know David Ross to be smart, 

innovative and practical in all of his professional dealings. l fully expect him to 

bring those qualities with him to the Office of Water." 

Todd Parfitt, director, Wyoming Department of Environmental Quality: "Mr. 

Ross possesses the necessary tools to effectively and appropriately oversee EPA's 

Water program in a fair, balanced and practical way. He has demonstrsted his 

ability to objectively analyze and consider inputs from all points of view and 

fommlate a fair and reasoned approach resulting in clear and concise decisions." 

Steve Quarles,. attorney at Nossaman LLP, former deputy under secretary of 

the U.S. Department of the Interior (Carter): "!have worked witlt Dave for 

many years as law firm partners. Dave's greatest skill may be leading people with 

diverse views and interests to common ground. People with such diverse views 

and interests naturally gravitate to Dave and look to him for leadership. This 

happens becHuse Dave is highly intelligent, both in tnastering issues and devising 

innovative solutions, and is an excellent listener, encouraging all to participate. 

He also has exhibited masterful administrative skills- from leading informal 

cohorts of private attorneys through complex decision making to managing high 

perfonning public offices." 

Gary Rikard, director, Mississippi Department ofEnvironmental Quality: "I 

believe Dave Ross would be an excellent addition to EPA's Office of Water. His 

experience and real world view in working for two different states would enhance 

this administration's goal of improving cooperative federalism and building 

relationships between EPA and the states in administering environmental 

regulations and policy. That perspective, along with his environmental experience 

and legal background, will be an asset for tl1e Agency." 

Matthias Sayer, deputy cabinet secretary, New Mexico Energy Minerals and 

Natural Resource Department: "We out west are beyond satisfied with the 

appointment of Mr. Ross as the assistant administrator for Water. Mr. Ross has a 

full understanding of those statutes aimed at protecting our water, coupled witl1 a 

full understanding of bow those statutes can and do impact state and local 

communities. Furthermore, through his boots on the ground experience, Mr. Ross 

has gained an appreciation for the important role states play, both in the east and 

dryer west, in protecting our water, and he understands that it is by working in 

cooperation with the states that the greatest degree of success in this important 

program will be achieved." 

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