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76–014 2012

THE TOXIC SUBSTANCES CONTROL ACT AND 

PERSISTENT, BIOACCUMULATIVE, AND TOXIC 

CHEMICALS: EXAMINING DOMESTIC AND INTERNATIONAL ACTIONS 

HEARING 

BEFORE THE

SUBCOMMITTEE ON COMMERCE, TRADE, 

AND CONSUMER PROTECTION 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED ELEVENTH CONGRESS 

SECOND SESSION 

MARCH 4, 2010 

Serial No. 111–102 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 


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COMMITTEE ON ENERGY AND COMMERCE 

HENRY A. WAXMAN, California, Chairman 

JOHN D. DINGELL, Michigan 

Chairman Emeritus 

EDWARD J. MARKEY, Massachusetts 

RICK BOUCHER, Virginia 

FRANK PALLONE, JR., New Jersey 

BART GORDON, Tennessee 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

BART STUPAK, Michigan 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

Vice Chairman 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANE HARMAN, California 

TOM ALLEN, Maine 

JANICE D. SCHAKOWSKY, Illinois 

CHARLES A. GONZALEZ, Texas 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

CHARLIE MELANCON, Louisiana 

JOHN BARROW, Georgia 

BARON P. HILL, Indiana 

DORIS O. MATSUI, California 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

CHRISTOPHER S. MURPHY, Connecticut 

ZACHARY T. SPACE, Ohio 

JERRY MCNERNEY, California 

BETTY SUTTON, Ohio 

BRUCE L. BRALEY, Iowa 

PETER WELCH, Vermont 

JOE BARTON, Texas 

Ranking Member 

RALPH M. HALL, Texas 

FRED UPTON, Michigan 

CLIFF STEARNS, Florida 

NATHAN DEAL, Georgia 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOHN B. SHADEGG, Arizona 

ROY BLUNT, Missouri 

STEVE BUYER, Indiana 

GEORGE RADANOVICH, California 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 


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SUBCOMMITTEE ON COMMERCE, TRADE, AND CONSUMER PROTECTION

BOBBY L. RUSH, Illinois 

Chairman 

JANICE D. SCHAKOWSKY, Illinois 

Vice Chair 

JOHN SARBANES, Maryland 

BETTY SUTTON, Ohio 

FRANK PALLONE, New Jersey 

BART GORDON, Tennessee 

BART STUPAK, Michigan 

GENE GREEN, Texas 

CHARLES A. GONZALEZ, Texas 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

DORIS O. MATSUI, California 

KATHY CASTOR, Florida 

ZACHARY T. SPACE, Ohio 

BRUCE L. BRALEY, Iowa 

DIANA DEGETTE, Colorado 

JOHN D. DINGELL, Michigan (ex officio) 

CLIFF STEARNS, Florida 

Ranking Member 

RALPH M. HALL, Texas 

ED WHITFIELD, Kentucky 

GEORGE RADANOVICH, California 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

MICHAEL C. BURGESS, Texas 


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C O N T E N T S 

Page 

Hon. Bobby L. Rush, a Representative in Congress from the State of Illinois, 

opening statement ................................................................................................ 1 

Hon. Ed Whitfield, a Representative in Congress from the Commonwealth 

of Kentucky, opening statement ......................................................................... 3 

Hon. Janice D. Schakowsky, a Representative in Congress from the State 

of Illinois, opening statement .............................................................................. 4 

Hon. Joe Barton, a Representative in Congress from the State of Texas, 

opening statement ................................................................................................ 5 

Prepared statement .......................................................................................... 6 

Hon. John D. Dingell, a Representative in Congress from the State of Michigan, prepared statement ...................................................................................... 11 

Hon. Joseph R. Pitts, a Representative in Congress from the Commonwealth 

of Pennsylvania, opening statement ................................................................... 13 

Hon. Diana DeGette, a Representative in Congress from the State of Colorado, opening statement ...................................................................................... 13 

Hon. Steve Scalise, a Representative in Congress from the State of Louisiana, 

opening statement ................................................................................................ 14 

Hon. Gene Green, a Representative in Congress from the State of Texas, 

opening statement ................................................................................................ 15 

Hon. Phil Gingrey, a Representative in Congress from the State of Georgia, 

opening statement ................................................................................................ 16 

Hon. Betty Sutton, a Representative in Congress from the State of Ohio, 

opening statement ................................................................................................ 17 

Hon. Henry A. Waxman, a Representative in Congress from the State of 

California, prepared statement ........................................................................... 83 

Hon. Kathy Castor, a Representative in Congress from the State of Florida, 

prepared statement .............................................................................................. 85 

WITNESSES

Jim Jones, Deputy Assistant Administrator, Office of Prevention, Pesticides 

and Toxic Substances, Environmental Protection Agency ................................ 19 

Prepared statement .......................................................................................... 22 

Answers to submitted questions ...................................................................... 135 

John Thompson, Division Director, Office of Environmental Policy, Bureau 

of Oceans, Environment and Science, Department of State ............................. 28 

Prepared statement .......................................................................................... 30 

Linda Greer, Director, Health and Environment Program, Natural Resources 

Defense Council .................................................................................................... 35 

Prepared statement .......................................................................................... 38 

Christina Cowan-Ellsberry, CE2 Consulting, Former Principal Scientist, Environmental Sciences Department, Procter and Gamble ..................................... 44 

Prepared statement .......................................................................................... 46 

Answers to submitted questions ...................................................................... 158 

Ted Sturdevant, Director, Department of Ecology, State of Washington ........... 53 

Prepared statement .......................................................................................... 55 

Answers to submitted questions ...................................................................... 153 

William J. Adams, Chairman, North American Metals Council ......................... 63 

Prepared statement .......................................................................................... 65 

Answers to submitted questions ...................................................................... 167 


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VI 

SUBMITTED MATERIAL

Committee Memorandum ........................................................................................ 87 

Letter of February 23, 2010, from Safer Chemicals Healthy Families to Subcommittee .............................................................................................................. 93 

Letter of March 3, 2010, from Environmental Working Group to Subcommittee .............................................................................................................. 110 

Letter of March 2, 2010, from the National Council of Churches to Subcommittee .............................................................................................................. 114 

Letter of March 3, 2010, from Pesticide Action Network to Subcommittee ........ 116 

Letter of February 18, 2010, from American Public Health Association Subcommittee .............................................................................................................. 118 

Letter of March 3, 2010, from American Chemistry Council to Subcommittee . 120 

Statement of National Petrochemical & Refiners Association ............................. 132 


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THE TOXIC SUBSTANCES CONTROL ACT AND 

PERSISTENT, BIOACCUMULATIVE, AND 

TOXIC CHEMICALS: EXAMINING DOMESTIC 

AND INTERNATIONAL ACTIONS 

THURSDAY, MARCH 4, 2010 

HOUSE OF REPRESENTATIVES,

SUBCOMMITTEE ON COMMERCE, TRADE, 

AND CONSUMER PROTECTION, 

COMMITTEE ON ENERGY AND COMMERCE, 

Washington, DC. 

The Subcommittee met, pursuant to call, at 10:16 a.m., in Room 

2322 of the Rayburn House Office Building, Hon. Bobby L. Rush 

[Chairman of the Subcommittee] presiding. 

Members present: Representatives Rush, Schakowsky, Sarbanes, 

Sutton, Green, Barrow, DeGette, Dingell, Whitfield, Radanovich, 

Pitts, Gingrey, Scalise, and Barton (ex officio). 

Staff present: Michelle Ash, Chief Counsel; Rebecca Brown, EPA 

Fellow; Will Cusey, Special Assistant; Daniel Hekier, Intern; 

Angelle Kwemo, Counsel; Timothy Robinson, Counsel; Lindsay 

Vidal, Special Assistant; Jerry Couri, Minority Senior Professional 

Staff; Sam Costello, Minority Legislative Analyst; Shannon 

Weinberg, Minority Counsel; Brian McCullough, Minority Senior 

Professional Staff; Robert Frisby, Minority FTC Detailee; and Will 

Carty, Minority Professional Staff. 

OPENING STATEMENT OF HON. BOBBY L. RUSH, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS 

Mr. RUSH. The hearing is called to order. This hearing is called 

for the purpose of discussing the matter of TSCA and the hearing 

is entitled the Toxic Substances Control Act and Persistent, Bio-Accumulative, and Toxic Chemicals: Examining Domestic and International Actions, and the chair recognizes himself for 5 minutes. 

I want to welcome all of you who are here this morning to participate in today’s hearing on the Toxic Substances Control Act and 

specific efforts that have been, or need to be, taken to protect public health, and the environment, from a diverse array of toxic substances. 

Our focus today is on a special group of chemicals known as 

PBTs that pose unique risks to human health and environment 

safety. Even at a very low exposure and concentration levels in our 

communities, our homes, our workplaces and the environment, 

PBTs have been linked to adverse health effects in humans and in 

animals. Some of the effects include cancers, and some include geVerDate Mar 15 2010 02:44 Nov 27, 2012 Jkt 076014 PO 00000 Frm 00007 Fmt 6633 Sfmt 6633 E:\HR\OC\A014.XXX A014

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netic mutations, and some include the disruption of normal biological, neurological and hormonal functions of our bodies. 

Examples of commonly known PBTs include unwanted wastes 

like mercury and dioxins. The list also includes pesticides like DDT 

and HCB. DDT, as most of you know, is a well-known synthetic 

pesticide. Also included in this list of potential toxins is HCB or 

hexachlorobenzene and other industrial chemicals, such as PCBs 

and heavy metal including cadmium, and mercury and lead. 

The way I understand PBTs is to think of them in the following 

way, and generally speaking the P, or persistence, relates to environmental safety. Persistent pollutants or toxins are not biodegradable. That means that these chemicals do not break down easily in 

the environment. You can think of them in the way you think of— 

I like to think of them as unwelcome house guests who don’t know 

when it is time to leave. 

The B stands for bioaccumulative or bioaccumulation and it relates to human health and to the environment. Following their release into the environment, some of these substances concentrate 

in rising proportions in soils, sediments, water and in the air. Over 

time, these concentration levels rise continually within, and to the 

top of, the human food chain. 

And the T, which stands for toxic or toxins, relates to human 

health. Toxic substances lead to adverse health effects, such as the 

ones I described earlier. 

What is also important to remember is that these are not mutually exclusive categories. While it can be presumed that a chemical 

substance which displays all three characteristics is especially 

harmful, a chemical substance or a mixture can display just one of 

the three characteristics, that is, it can be persistent, bioaccumulative or toxic to human health. These substances are capable of 

traveling great distances on air or in oceanic currents. 

Last year, I had the honor of receiving a delegation of indigenous 

peoples from the Savoonga and Gambell nations. These representatives were from two member tribes of the National Congress of 

American Indians. They told my staff of serious public health 

issues they are experiencing as a result of pollutants, particularly 

legacy chemicals such as PBDEs [polybromodiphenyl ethers] and 

PFCs [perflourinated compounds], that have blown and crested 

onto St. John’s Island. 

At our last hearing on TSCA in November, 2009, we discussed 

the need for including a prioritizing scheme in our soon-to-be-introduced bill, which will make critical reforms to the existing 33-yearold statute. Under this scheme, the Environmental Protection 

Agency’s chemical risk and safety assessment responsibilities 

would be radically streamlined. With this new authority, the EPA 

will be able to take much swifter action to reduce the volume of especially threatening substances that are already in the commercial 

stream, that are in our bodies, and that are in our food and water 

sources. 

I am pleased to welcome all six of our witnesses to this subcommittee this morning. The common thread through all of their 

testimonies is, obviously, PBTs. Today, each one of them will talk 

about the PBT problem and how to go about addressing it from 

their perspectives as government regulators, policy makers, public 


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interest and health advocates, and from the perspective of the industry. Each of these witnesses is prepared to testify and answer 

questions about PTC regulation and remediation by assessing the 

regulatory lay of the land, and meaning that the State and Federal 

levels are of concern to them and, of course, the impact of these 

chemicals on our planet. We have got just this one planet here and 

we got to be concerned about it, and we got to protect it, and we 

got to make sure that it will be around for a long, long, long time. 

It is a gift to us and we have got our responsibility to be able to 

pass it on a healthy path to generations to come. 

And I want to thank you and I yield back the balance of my time. 

And now I will recognize the ranking member from this subcommittee, my friend, the gentleman from Kentucky, Mr. Whitfield, for 5 minutes. 

OPENING STATEMENT OF HON. ED WHITFIELD, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH OF KENTUCKY 

Mr. WHITFIELD. Chairman Rush, thank you very much for holding this hearing on the Toxic Substances Control Act. 

Today we will explore what many believe are the most generous 

chemicals, PBTs. These are chemicals and substances that are 

long-lasting and can build up in the food chain to levels that 

present threats to humans and the environment. We must take 

steps, obviously, the ensure Americans and the environment are as 

safe from these hazardous chemicals as possible but I also firmly 

believe that high-quality science, that is science that is measurable, 

reliable, relevant and that can be reproduced should lead the way 

for whatever reforms this Congress makes to current law. 

Mr. Chairman, I understand that at some point it is your intention to move legislation to reform TSCA. I am pleased that you are 

going to do that and I hope that we on this side of the aisle have 

an opportunity to work with you and your staff as you write this 

legislation. 

With that said, it is my hope that any action we do take does 

not have adverse consequences similar to those that the toy bill has 

had. We need to recognize the nuances of the science and give importance to exposure and risk data, not just hazards. 

When this committee applied a precautionary ethos to the Consumer Product Safety Improvement Act, we closed down many 

small businesses because they simply cannot meet the requirements that we insisted upon. And I might also mention that in an 

op-ed piece in the Wall Street Journal this past Christmas season, 

a former colleague of ours now a commissioner at the CPSC, Consumer Protection, said that the new law reduced the Consumer 

Product Safety Commission’s longstanding discretion to act in response to genuine risks, substituting instead the rigid broad brush 

and unscientific judgment of Congress. As we have seen, good intentions do not always lead to good results and I will simply urge 

that we continue to heed the lessons learned from the particular 

law. 

I do look forward to hearing today from our witnesses, all of who 

are experts in their field, as we try to delineate between organic 

and inorganic PBTs, as we look at how widespread and effective 


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are the States that are working in this area. And then, of course, 

I think it is imperative that we also explore our international leadership and the fact that a number of important treaties that we are 

signatories have not been affirmed or confirmed by the U.S. Senate. 

Mr. Chairman, while it has been over 3 decades since this law 

has been reformed, I again would like to stress the importance that 

we examine the issues carefully before we make sweeping changes 

that could adversely impact commerce, innovation and, of course, 

public and environmental health. We approach this subject with 

the very best of intentions and particularly in today’s economic 

downturn I think that it is particularly important that we be mindful of the impact that any actions we may take on the job market. 

And I yield back the balance of my time. Thank you. 

Mr. RUSH. The chair now recognizes my friend, my colleague 

from Illinois, the vice chairman of the subcommittee, Ms. Schakowsky for 2 minutes for the purposes of opening statements. 

OPENING STATEMENT OF HON. JANICE D. SCHAKOWSKY, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS 

Ms. SCHAKOWSKY. Thank you, Mr. Chairman, for holding this important hearing. 

This is the third we have held in the 111th Congress on the 

Toxic Substances Control Act and I look forward to working with 

you and Chairman Waxman on reforming the law so that it protects our community from harmful products, from harmful pollutants. When Congress passed TSCA, it’s intention was to give EPA 

the tools it needed to protect the public from exposure to toxic 

chemicals that cause serious harm, however, more than 30 years 

later, as has already been stated, the scientific evidence is overwhelming that chemicals continue to persist in our environment, 

are a significant contributor to the problems of many diseases. Leukemia, brain cancer, other childhood cancers have increased by 20 

percent since TSCA became law. We know for certain that exposure 

to substances like asbestos and mercury and many others pose lethal or catastrophic results. What these startling facts tell us is 

that TSCA in its current form is completely incapable of protecting 

the public and that it is imperative for Congress to amend the law 

so that it can safeguard the American people from exposure to lethal chemicals. 

Today we hear from our witnesses about a specific subset of 

chemicals that meet the criteria for being labeled as persistent, bioaccumulative and toxic, PBTs, and I appreciate them. I appreciate 

our witnesses for being here today to shed light on these especially 

devastating chemicals and, again, Mr. Chairman, I thank you for 

holding the hearing. 

And I yield back the balance of my time. 

Mr. RUSH. The chair now recognizes the ranking member of the 

full committee and the gentleman from Texas, Mr. Barton, for 5 

minutes. 


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OPENING STATEMENT OF HON. JOE BARTON, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. BARTON. We thank you, Chairman Rush. 

Before I give my opening statement, I want to say some words 

about our newest ranking member of this subcommittee, my good 

friend from Kentucky, Mr. Whitfield. I specifically asked him to 

take over for Congressman Radanovich because of Mr. 

Radanovich’s situation with the death of his wife and the requirements that he take care of his young son. He didn’t have the capability or the time to give the ranking membership his full attention 

and I understand that. 

I specifically asked Mr. Whitfield to take on the duties of this 

subcommittee’s ranking membership because it is my expectation, 

Mr. Chairman, that at some point in time you and Chairman Waxman intend to move legislation reforming TSCA, and I wanted my 

very best, senior, experienced person at the helm and that is Ed 

Whitfield. He has worked in both the majority and the minority on 

this subcommittee and he knows the issues well. He knows also the 

personalities well and he has the confidence of both sides of the 

aisle so it was not serendipity that Ed Whitfield got asked to take 

this ranking membership and I think it speaks to his capabilities 

that he has already hit the ground running. 

I might also say, Mr. Chairman, that this is an important hearing and I think if you just look out in the audience you see former 

general counsels for the committee, and chiefs of staff for the committee and they don’t come cheap, Mr. Chairman. They are here 

because this is a big deal and it is an important deal and it speaks 

to your leadership that you are taking this complex subject. 

On the issue at hand, we understand that PBTs are extremely 

toxic and can be hazardous. We understand that they need to be 

regulated closely and monitored continuously. 

We do have a witness from the Pellston Working Group here that 

has done some groundbreaking research and if their research is 

correct, Mr. Chairman, there is a possibility that we can adopt a 

more flexible regulatory approach based on not only the definition 

of what is hazardous but what the risk is of that hazard. So I am 

looking forward to their testimony, plus obviously the testimony of 

the other witnesses here. 

Congress does not normally do complex, technical issues well. As 

Mr. Whitfield has pointed out, in the Consumer Protection Act reauthorization last year, I don’t think it was intentional but we 

adopted a regulatory approach for lead which is basically zero tolerance and because of that there are many products that are no 

longer on the marketplace today that really didn’t have any potential harm to the population. So in this case, I hope that we do listen to our panels and we do work together in a bipartisan fashion 

to move a bill if that is the wish of the chairman and yourself, Mr. 

Chairman at the subcommittee level, that encompasses the latest 

science, the latest data and so that we get this one right. 

And with that, Mr. Chairman, I yield back. 

[The prepared statement of Mr. Barton follows:] 


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Statement of the Honorable .Joe Barton 

Hearing on "TSCA and Persistent, Bioaeeumulative, and Toxic Chemicals" 

Subcommittee on Commerce, Trade, and Consumer Protection 

March 4, 2010 

Mr. Chairman, thank you for calling today's hearing on the topic of 

Persistent, Bioaccumulative, and Toxic chemicals. 

Before I get to my remarks on the subject of this hearing, and because 

this is the first hearing held exclusively by this subcommittee, I want to 

congratulate our newest Ranking Member to this subcommittee, Ed 

Whitfield of Kentucky. Mr. Whitfield is no stranger to the jurisdiction 

of this subcommittee as he previously served as our Ranking Member 

and he will do an outstanding job again. 

Concerning the subject of the hearing, I look forward to the testimony 

of our witnesses today on this subject. We all know that PBTs are 

toxic, long-lasting chemical substances and mixtures that can build up 

in the food chain to levels that are harmful to human health and the 

ecosystem.. Some have associated exposure to PBTs with a range of 

adverse human health effects, including effects on the nervous system 

and reproductive system of those exposed entities. 
7 


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Protecting the public from the real risks concerning PBTs should be our 

fundamental goal and we should rely on science that is measurable, 

repeatable, reliable, and relevant in order to do so. In this hearing, we 

should endeavor to clearly define what a PBT is, based upon sound 

screening and evaluations, rather than simplistic notions. We also need 

to know just how many PBTs are out there in commerce and whether 

new PBTs are being produced and, if so, whether they are occurring at 

high volumes. 

I am aware that a distinguished panel of scientists, known as the 

Pellston workshop, recently concluded that an evolution of science has 

produced new insights into persistence, bioaccumulation, and toxicity 

of chemical substances, and provided an array of new methods to 

identify PBT chemicals. Importantly, Pellston workshop findings argue 

that the appearance of a PBT in the environmental is not enough to 

warrant regulation, but rather, body or tissue residues showing a direct 

causal link to adverse responses are necessary to justify regulatory 

management. 
8 


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I agree with this assessment and that is why I have a hard time 

supporting a rigid, PBT criteria to all chemical substances. We need to 

recognize the nuances of the science and treat exposure and risk data 

importantly. This committee got itself into a lot of hot water in the last 

Congress when it applied an overly precautionary ethos to the 

Consumer Product Safety Improvement Act. We have small businesses 

that are shutting their doors based upon well-intentioned, but badly 

constructed law. As we heard at the endocrine hearing last week, 

decisions based on incomplete or low-quality science can have serious 

negative effects for everyone. 

I also hope that we can have a robust discussion today about the 

difference between organic and inorganic PBTs. There is a clear 

difference in these substances, and even the Europeans have recognized 

this value. 

I also understand states are taking actions and I want to know how a 

coordinated Federal eff0l1 is either helped or hurt by these actions - not 
9 


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to mention what it means for international effOlis by the Executive 

Branch. 

Finally, I understand that some PBTs, because they are organic, have 

the ability to travel long distances. These PBT's, also called Persistent 

Organic Pollutants or POPs, are the subject ofthe Stockholm 

Convention and the Arhus Protocol on long range air pollution caused 

by POPs. The U.S. is a signatory to these agreements, but is not a full 

party. The EPA and the State Depalimcnt may push for implementing 

legislation" but I am curious whether the Obama Administration will 

push the U.S. Senate to ratify thesc agreements. 

Mr. Chairman, again, I look forward to thc testimony of our witnesses 

and appreciate your indulgence. 
10 

Mr. RUSH. The chair thanks the ranking member. 

The chair is proud now to introduce the gentleman from Michigan, the chairman emeritus for the entire committee, who has provided leadership for this committee and on this particular issue for 

many years, and he should have been introduced earlier but somehow the chairman did not see him over there which is attributed 

to my bad eyesight. And so now the chair recognizes Mr. Dingell 

for 5 minutes for opening statements. 

Mr. DINGELL. Thank you, Mr. Chairman. 

First, I want to express my gratitude to you for your kind words 

and second, I would like to observe this meeting and this hearing 

as very, very important and useful. And I know under your leadership, we will begin a process of reviewing carefully TSCA of what 

it is doing, what it is not doing, how the changes of technology and 

other things over the past years, some 30 of which have passed 

since we have done this legislation in the first place, and how those 

things have changed the circumstances. We are also going to need 

to know what changes we have to make in the legislation and it 

is my hope that these things will be done carefully under your 

leadership, and I know that you will do this wisely and I think that 

the information to be achieved will be very valuable. 

Mr. Chairman, with that I ask unanimous consent to revise and 

extend my remarks and I thank you for your courtesy. 

[The prepared statement of Mr. Dingell follows:] 


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",,' -\' <. 111 // w ) 

, l·lL c'L.' I ':l" 

/V' f;·,·c<,t' (' ~ 

Statement of Representative John D. Din2.e1l .. ' ' ------,. 

Chairman Emeritus, House Committee on Energy and Commerce 

Subcommittee on COIllmerce, Trade, and Consumer Protection 

"TSCA and Persistent, 13ioaccumulative, and Toxic Chemicals: Examining Domestic and 

International Actions" 

March 4, 20] 0 

1\11'. Chairman thank you for holding this hearing today. After 33 

years, it has become blatantly clear TSCA needs a thorough examination 

and reauthorization. \Ve have heard this f)'om industry, environmental 

groups and consumer advocacy organizations. Indeed, EPA has not 

banned a single chemical under TSCA in nearly 20 years. Despite our 

best intentions back in 1976, TSCA is not working as we had hoped it 

would when it was enacted. 

Today we are here to discuss Persistent Bioaccumulative and Toxic . / 

chemicals (PBTs) - chemicals with all three characteristics are 

considered particularly harmful. I have a particular interest in PBTs 

since I come from the Great Lakes state. 

Because oftheir nature. PBTs have also been the subject of international 

agreements the PIC Convention, the Convention on Long Range 

Transboundary Air Pollutants, and the 200 I Stockholm Convention. 
12 


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It is clear that PBTs are a unique category oftoxies and they require 

special consideration both internationally and domestically. I look 

forward to hearing from the witnesses on this point. 

Again, Mr. Chairman, I want to thank you for the deliberate and 

thoughtful approach the Subcommittee is taking on this matter. It is 

important address TSCA the right way in order to not only get the 

desired result ofa more workable law that protects human health, but 

also ensure that we do needlessly inflict financial burdens producers in 

this extremely difficult economic climate. 

2 
13 

Mr. RUSH. The chair now recognizes the gentleman from Pennsylvania, Mr. Pitts, for 2 minutes. 

OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH 

OF PENNSYLVANIA 

Mr. PITTS. Thank you, Mr. Chairman. Thank you for holding this 

important hearing on the Toxic Substance Control Act and the subset of chemicals that meet the criteria for being labeled as persistent, bioaccumulative and toxic. 

PBTs are considered to be particularly harmful because they are 

long-lasting chemical substances and mixtures that can build up in 

the food chain to levels that are harmful to human and ecosystem 

health. PBTs can transfer easily and linger for a long time in people and the environment, and they are associated with adverse 

human health effects. 

We should take this subject very seriously. None of us want 

these substances negatively impacting humans or the environment 

however we must prudently go about regulating these chemicals. 

There are some that argue that the appearance of a PBT in the environment is not enough to warrant regulation but rather body or 

tissue residues showing a direct causal link to adverse responses 

are necessary to justify regulatory management. 

Additionally, some experts make a case that regulatory action 

should be based on complete information in order to avoid negative, 

unintended consequences. For example, PBT screening criteria assesses only hazard and not risk. Something may be hazardous and 

not pose a risk if its exposure is controlled and hazard assessment 

only provides information on the properties of the substance not 

the likelihood of the facts. This is comparable to problems that 

have resulted from taking a similar approach to lead contents limits in the Consumer Product Safety Improvement Act which has led 

to the elimination of products that have not demonstrated a risk 

of lead poisoning. 

Our committee should move forward with this example in mind. 

Yet I urge us to continue to place safety as the highest goal. 

I appreciate the witnesses being here today. I look forward to listening to your testimony. 

I thank you and I yield back. 

Mr. RUSH. The chair now recognizes the gentleman from Georgia. 

He is no longer here. 

The chair recognizes the gentlelady from Colorado, a leading 

voice on these and other matters, Ms. DeGette, for 2 minutes. 

OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF COLORADO 

Ms. DEGETTE. Thank you very much, Mr. Chairman. 

Mr. Chairman, ever since Rachel Carson’s landmark book, Silent 

Spring, we have known the dangers of chemicals like DDT that 

persist in the environment, bioaccumulate and are highly toxic. 

When these chemicals move up the food chain, they increase in 

concentration and their effects can linger for decades. So as the 

species at the very top of the food chain, this should worry us. DDT 


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was banned in 1972 but its effects are felt today. Now, DDT is a 

pesticide covered under FIFRA that many harmful PBT chemicals 

are covered under the much weaker regime of TSCA. 

One of those chemicals is mercury. In 2004, my State of Colorado 

initiated a 5-year study to assess the levels of mercury in fish in 

the State. Two lakes just outside of Denver were found to have fish 

with high levels of mercury and local residents are now advised not 

to eat fish from these lakes. Colorado’s lakes are not unique, unfortunately and it just shows why TSCA reform is badly needed. 

TSCA was enacted over 30 years ago and it is our only major environmental law that has not been reauthorized. 

Now, one of the most important considerations in TSCA reform 

as some of my colleagues on the other side of the aisle have mentioned this is how to characterize the risk posed by various chemicals. Focusing on those chemicals that persist in the environment 

and are highly toxic make sense and I want to point out also, I 

agree 100 percent with Mr. Whitfield and others who say that we 

should use science as the basis of our consideration as we look towards reauthorizing this bill. And I will also point out to our credit 

in this committee, when we reauthorized the Consumer Product 

Safety Act last year, we may have had some issues with lead and 

other substances but due to some very good conversations with me 

and others on this committee, we worked out what to do with 

phthalates in a bipartisan way and also in a bicameral way that 

is science-based and that we were all very pleased with. So, Mr. 

Chairman, I look forward to working with you and everyone on this 

committee to make sure that not just we are safe from these PBT 

chemicals but that our grandchildren are also safe as these chemicals move up the food chain. 

Mr. RUSH. The chair recognizes the gentleman from Louisiana, 

Mr. Scalise, for 2 minutes. 

OPENING STATEMENT OF HON. STEVE SCALISE, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF LOUISIANA 

Mr. SCALISE. Thank you, Mr. Chairman and Ranking Member 

Whitfield, for having this hearing today. I also want to thank our 

witnesses for taking the time to be with us. 

I believe we can all agree that the issue of persistent, bioaccumulative and toxic chemicals, otherwise known as PBTs, is an important one that we must continue to examine. I am pleased that this 

subcommittee is once again taking up the issue of toxic substances 

and the laws governing their use in commerce. 

The use and regulation of toxic substances and of chemicals in 

general is an issue that we all must take very seriously. First, because of the effects certain chemicals can have on our health and 

the environment. I know from hearing from the statements of my 

colleagues made today that they share these concerns but we also 

want to make sure that the chemicals that are produced, used and 

imported into our country are safe. But this issue is also important 

to be because of the chemical industry’s presence in my home State 

of Louisiana and because of its importance to our national economy. 


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According to the American Chemistry Council, over 96 percent of 

all manufactured goods are directly touched by the business of 

chemistry, making this industry a vital part of every aspect of our 

economy. In Louisiana, the chemical industry directly employs over 

22,000 people and for every chemistry industry job in Louisiana, an 

additional 4.5 jobs are created in our State, and one thing that 

must be pointed out is this chemical industry, these jobs are highpaying. The average wage of a chemistry industry employee in Louisiana is over $82,000, which is 53 percent higher than the average 

manufacturing wage in the State. During these tough economic 

times, these are the kind of jobs we need to be creating more of. 

As this committee continues to consider legislation, we must 

make our decisions based on real science that is measurable, reliable and reproducible. We must also consider the unintended consequences of actions that might well be well-intentioned but don’t 

fix the problems yet produce devastating consequences as was the 

case in the last Congress when changes to the Consumer Product 

Safety Improvement Act shut down small businesses in America. 

Again, it is clear that there are harmful chemicals like PBTs out 

there that can have harmful effects if not used properly, and the 

proper safeguards need to be put in place, and we know that the 

EPA has been taking steps to ensure that is the case. I think the 

key finding is the appropriate balance between protecting our 

health and environment, and protecting a vital sector of our economy and the jobs in this industry. I believe these goals are not mutually exclusive. 

I look forward to hearing from our panelists today on actions 

that have been taken in other States and other countries to put 

protections in place. And I am interested in our panelists’ thoughts 

on the use of exposure and risk data, things that in my opinion 

should be based on sound science and should be used along with 

data on the hazards that chemicals may pose. 

Thank you, Mr. Chairman, and I yield back. 

Mr. RUSH. Mr. Barrow is recognized for 2 minutes. The chair 

thanks the gentleman. 

Mr. Green is recognized for 2 minutes. 

OPENING STATEMENT OF HON. GENE GREEN, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. GREEN. Thank you, Mr. Chairman, for holding this hearing 

on continued looking at the modernization of the Toxic Substance 

Control Act. I also want to welcome and congratulate our new 

ranking member, Congressman Whitfield, and look forward to 

working with him as we move forward on TSCA modernization and 

other matters before the subcommittee. 

The issue we are looking at today, persistent, bioaccumulative 

and toxic chemicals, or PBTs, are widely agreed to be a small but 

potentially dangerous class of chemicals. Their ability to build up 

in the food chain and persist over long periods of time pose a significant danger to human health and the environment, a fact that 

the EPA has recognized as they have taken action to implement 

more rigorous screenings for chemicals that display characters of 

PBTs. These actions include lower reporting thresholds for PBTs on 

the toxic release inventory, the development of prioritization of tool 


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for the waste streams containing PBTs and reviewing TSCA premanufacturing notices for substances that meet PBT-related criteria. 

I look forward to our witnesses today and what further steps we 

can take to domestically further protect human health and environment but also the important international area. Transboundary migration of pollutants is an important issue and one this committee 

has worked on for some time through efforts to implement the 

Stockholm Convention on Persistent Organic Pollutants to LongRange Transboundary Air Pollution, POPs protocol in the Rotterdam Convention on the Prior Informed Consent. Passing legislation of these treaties should be a priority in any TSCA modernization legislation this committee takes up. 

Mr. Chairman, I know I am almost through with my time but 

I would like to ask unanimous consent to place a letter into the 

record from the American Chemistry Council in today’s hearing. 

ACC has long supported implementing the international treaties 

and it sees U.S. leadership in this area as critical action in the 

international area, and I would encourage if we haven’t started it 

to establish a working group of all the interested parties of such 

major legislation and I would hope we could pass it through this 

Congress. 

Mr. RUSH. The chairman thanks the gentleman and without 

hearing no objection, the letter will be included into the record. 

[The information appears at the conclusion of the hearing.] 

Mr. RUSH. We recognize Dr. Gingrey for 2 minutes for the purposes of opening statements. 

OPENING STATEMENT OF HON. PHIL GINGREY, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF GEORGIA 

Mr. GINGREY. Mr. Chairman, thank you for calling this third 

hearing on the Toxic Substance Control Act of 1976. I am happy 

that we have once again delved into this complex issue and I appreciate the diligence of Commerce, Trade, and Consumer Protection Subcommittee to continue to examine this important issue. 

TSCA directs the Environmental Protection Agency to regulate 

all phases of manufacturing of chemicals and to identify unreasonable risk of injury from new or existing chemicals. When regulating 

these chemicals, TSCA directs the EPA to use the least burdensome option to reduce the risk of harm while balancing the benefits 

provided by the chemical. As a risk-based law, TSCA relies on the 

presence of sound science promote the chemical produces and the 

EPA in order to properly implement the law. 

Mr. Chairman, while there are many laudable elements of TSCA, 

that does not mean that this law is anywhere close to perfect. Since 

its enactment, chemical manufacturers and processes have advanced and so has technology. Accordingly, TSCA needs to best reflect the science that is currently being utilized. As we heard during our previous two hearings on this matter, TSCA reform is needed because we need to ensure the safety of chemicals used in all 

products, however, while there is that consensus, the way to accomplish the reform is certainly subject to debate and, indeed, some 

disagreement. 


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Today’s hearing looks at a different aspect of TSCA, and its domestic and international implications for health and environmental 

factors of persistent, bioaccumulative and toxic chemicals, PBT. 

Subsequently, today’s panel of witnesses will discuss the efforts 

taken by TSCA to maintain the safe use of chemicals both at home 

and abroad, however, I hope that we do not use this hearing as a 

vehicle to fundamentally overhaul TSCA because if we do, my fear 

is that we will jeopardize the long term viability of the chemical 

industry which will have lingering ramifications for other industries and subsequently, of course, our economy. 

Mr. Chairman, I would suggest that as we hear from our distinguished panel of witnesses today we keep in mind the underlying 

risk-based principles that guide the current implementation of 

TSCA for health and environment. I look forward to their testimonies. 

And I yield back. 

Mr. RUSH. The chair recognizes the gentlelady from Ohio, Ms. 

Sutton, for 2 minutes. 

OPENING STATEMENT OF HON. BETTY SUTTON, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF OHIO 

Ms. SUTTON. Thank you, Chairman Rush, for holding today’s important hearing on TSCA and the persistent, bioaccumulative and 

toxic chemicals also known as PBTs. 

This is a very serious issue. Our health, the environment and the 

public’s confidence are at issue and chemicals that are considered 

to be persistent, bioaccumulative and toxic have been associated 

with severe health risks and results, and these types of chemicals 

have been found in human bodies and that they can build up in 

our food chain and last for long periods of time in our environment. 

In fact, PBTs accounted for 97 percent of all fish consumption 

advisories in 2008, and my congressional district includes part of 

Lake Erie’s shoreline. 

In 1997, the U.S. and Canada launched the Great Lakes Bi-National Toxics Strategy to eliminate PBTs and according to the state 

of the Great Lakes 2009 report produced jointly by the U.S. EPA 

and Environment Canada, releases of targeted bioaccumulative 

toxic chemicals have declined significantly from their peak period 

in past decades. The report continues to state that ‘‘For the most 

part, bioaccumulative toxic chemicals no longer limit the reproduction of fish, birds and mammals.’’ And while this sounds like good 

news, there is still much work to be done. With funding from the 

Great Lakes Restoration Initiative, Ohio is investing $4.21 million 

in five projects to address toxic substances and reduce contamination. 

I have met with health care professionals in my congressional 

district who have expressed concern about health consequences 

that they have seen from chemical exposure in patients, as well. 

And I am interested to hear from today’s witnesses how the Toxic 

Substances Control Act can be modernized to more effectively address these very real health concerns. Industry and a variety of environmental, animal welfare, and health and safety groups have all 

stated that they support modernizing TSCA, and as we move forward, we need to ensure the public’s trust, and protect the public 


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and future generations from health and environmental harm while 

providing industry with a clear direction to ensure that our workers keep working. It must not be a question of jobs versus the environment. We can and we must effectively tend to both. 

And I yield back. 

Mr. RUSH. The chair now recognizes the gentleman from Maryland, Mr. Sarbanes, for 2 minutes. 

Mr. SARBANES. Thank you, Mr. Chairman. I appreciate your 

holding this third hearing on the Toxic Substances Control Act. 

My continuing perspective on this is that few Americans would 

imagine how thin the protections are when it comes to some of 

these chemicals and so it is really incumbent on us to try to modernize this oversight. I am going to be particularly interested to 

hear about how we can sort of get a head start based on the fact 

that it has been 30-plus years since this was modernized and 

science has certainly advanced significantly. So even if we are now 

going to come armed with a stronger set of standards for how we 

judge the toxicity of these various chemicals, I imagine there is a 

whole set of them that we already know are sinister enough that 

they ought to be put in a category right at the outset so that we 

can sort of start on the 30-yardline or the 40-yardline instead of on 

the 10-yardline, and I am looking forward to the testimony of the 

panel in that respect and otherwise on this important issue. 

And I yield back my time. Thanks. 

Mr. RUSH. The chair thanks all of the members for their opening 

statements. 

And it is now my pleasure and honor to introduce our witnesses. 

We have nine esteemed witnesses from both far and near and I 

want to really express to each and every one of you how grateful 

we are that you would take, you will take, the time out from your 

busy schedules to appear before this subcommittee and to give us 

your best in helping us and direct us as we travel down this path 

to modernizing and reauthorizing TSCA. 

I want to introduce now Mr. James Jones who serves as the deputy assistant administrator for the Office of Prevention, Pesticides 

and Toxic Substances for the Environmental Protection Agency. 

And seated next to Mr. Jones is Dr. John Thompson and he is the 

division director for the Office of Environmental Policy, Bureau of 

Oceans, Environment and Science at the Department of State and 

next to Dr. Thompson is Mr. Ted Sturdevant. Mr. Sturdevant is the 

director of the Department of Ecology for the great State of Washington. And seated next to Mr. Sturdevant is Dr. Linda Greer who 

is director of the Health and Environmental Program for the Natural Resources Defense Council. And to her left is Dr. Christina 

Cowan-Ellsberry and she is from CE2 Consulting, former principal 

scientist of the Environmental Sciences Department at Procter and 

Gamble. And lastly, we have with us this morning Dr. William J. 

Adams who is the chairman of the North American Metals Council. 

And I again want to welcome each and every one of you to this 

hearing. And it is the practice of this subcommittee to swear-in all 

of our witnesses, and so I want to ask that each one of you stand 

and raise your right hand and respond to this question. Do you solemnly swear to tell the truth, the whole truth and nothing but the 


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truth? Let the record reflect that the witnesses have all answered 

in the affirmative. 

And before we hear the opening statements of the witnesses, I 

must inform each and every one of you who are present that there 

are votes occurring. I don’t know how much time we have left on 

the votes right now. Less than 10 minutes so we will try to get to 

two or three and then we will have to see how many votes are 

there? Three? We have three votes so it will take us about a halfan-hour to get over there and get back so we ask that you just be 

patient with us while we go and vote. 

Dr. Sturdevant, we are going to try to finish you up before we 

have to go over there. Is that okay? Yes, thank you very much. 

Now, the chair recognizes Mr. Jones for 5 minutes. 

STATEMENTS OF JIM JONES, DEPUTY ASSISTANT ADMINISTRATOR, OFFICE OF PREVENTION, PESTICIDES AND TOXIC 

SUBSTANCES, ENVIRONMENTAL PROTECTION AGENCY; 

JOHN THOMPSON, DIVISION DIRECTOR, OFFICE OF ENVIRONMENTAL POLICY, BUREAU OF OCEANS, ENVIRONMENT 

AND SCIENCE, DEPARTMENT OF STATE; TED STURDEVANT, 

DIRECTOR, DEPARTMENT OF ECOLOGY, STATE OF WASHINGTON; LINDA GREER, DIRECTOR, HEALTH AND ENVIRONMENT PROGRAM, NATURAL RESOURCES DEFENSE COUNCIL; 

CHRISTINA COWAN-ELLSBERRY, CE2 CONSULTING, FORMER 

PRINCIPAL SCIENTIST, ENVIRONMENTAL SCIENCES DEPARTMENT, PROCTER AND GAMBLE; AND WILLIAM J. 

ADAMS, CHAIRMAN, NORTH AMERICAN METALS COUNCIL 

STATEMENT OF JAMES J. JONES 

Mr. JONES. Good morning, Chairman Rush and members of the 

subcommittee. 

I am Jim Jones, Deputy Assistant Administrator for Prevention, 

Pesticides and Toxic Substances at EPA. I am here today to talk 

about chemicals that are persistent, bioaccumulative and toxic, otherwise known as PBTs, and EPA’s domestic and international actions related to such chemicals. I appreciate the opportunity to be 

here today. 

As this committee knows, EPA’s mission is to protect public 

health and the environment. Ensuring that our citizens, and especially our children, are protected from exposure to unsafe levels of 

toxic chemicals and pollution by continually strengthening our 

chemical management regime is not only central to EPA’s work but 

it is an area that EPA Administrator Jackson identified as one of 

her priorities for the agency. 

You have asked me here today to talk about PBTs in particular. 

PBTs are long-lasting substances that build up in the food chain 

and at certain exposure levels may be harmful to human health 

and the environment. Their persistent property means that when 

they are released into the environment they remain essentially 

unaltered for months or years. With continued use and release, 

they build up in sediments and soil and their concentrations increase as they go up the food chain. It is this concentration in the 

food chain which, under certain circumstances, can cause adverse 

effects in humans or wildlife. Some PBTs are also susceptible to 


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long range transport such that adverse effects can be found far removed from their site of production or use. Combined, these properties are what make EPA concerned not only with historical PBT 

chemicals, such as DDT and PCBs, but also with chemicals with 

similar properties entering commerce today or in the future. And 

so I would like to take a few minutes to just touch on a few of the 

relevant domestic and international actions we have taken with respect to PBTs. 

On September 29 of 2009, EPA Administrator Jackson announced that EPA is putting in place a comprehensive approach to 

enhance the agency’s current chemicals management program 

under TSCA. On December 30 of 2009, EPA posted action plans on 

phthalates, perfluorinated chemicals, polybrominated diphenyl 

ethers and products, and short-chained chlorinated paraffins. The 

latter three are PBTs. These action plans summarize available hazard exposure and use information, outline the risks that each 

chemical may present and identify the specific steps the agency has 

taken to address those concerns. 

The initial chemicals selected for action plan development were 

chosen on the basis of multiple factors including chemicals identified as persistent, bioaccumulative and toxic as well as other factors. But while we are moving forward to implement the actions in 

those plans, we know that the very nature of PBTs means that 

stand-alone action by any one country is not enough. 

The global nature of many of these substances is why the Obama 

Administration identified the Stockholm Convention on Persistent 

Organic Pollutants, known as the POPs Convention, along with the 

Rotterdam Convention on Prior Informed Consent, known as the 

PIC Convention, as a priority treaty for U.S. ratification and why 

joining the POPs Protocol to the Convention on Long Range Transboundary Air Pollution, known as the LRTAP POPs Protocol, is in 

our interest. By joining with the rest of the world to phase out or 

reduce the use and release of these PBTs, we protect both human 

health and the environment, and not only for ourselves but for the 

rest of the world. 

At EPA we take the risks posed by these substances to our environment and public health very seriously but we are hampered by 

our lack of implementing legislation. As your committee considers 

the issue of PBTs, I would stress the importance of implementing 

legislation that would allow the United States to join the Stockholm Convention, the Rotterdam Convention and the LRTAP POPs 

Protocol. The Obama Administration thinks it is time to become 

parties to these agreements. 

Among our efforts to strengthen the agency’s chemical management regime, we have released a set of administration principles 

to help guide legislative reform and outline a series of activities to 

enhance our programs. Much of that work will encompass PBT 

substances and could provide an opportunity for the consideration 

of implementing legislation for the POPs Convention, the PIC Convention and the LRTAP POPs Protocol. We look forward to working 

with Congress, our domestic stakeholders and the international 

community to strengthen both our domestic and international actions with respect to PBT substances. 


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Thank you for having me here today and I will be happy to respond to any questions that you may have. 

[The prepared statement of Mr. Jones follows:] 


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TESTIMONY OF 

JAMES J. JONES 

DEPUTY ASSISTANT ADMINISTRATOR FOR 

PREVENTION, PESTICIDES AND TOXIC SUBSTANCES 

BEFORE THE 

SUBCOMMITTEE ON COMMERCE, TRADE, AND CONSUMER PROTECTION 

COMMITTEE ON ENERGY AND COMMERCE 

U.S. HOUSE OF REPRESENTATIVES 

March 4, 2010 

Good morning Chairman Rush and Members of the Subcommittee. I am James Jones, Deputy 

Assistant Administrator for Prevention, Pesticides and Toxic Substances at the United States 

Environmental Protection Agency. I am here today to talk about chemicals that are persistent, 

bioaccumulative, and toxic, otherwise known as PBTs, and EPA's domestic and international 

actions related to such chemicals. I appreciate the opportunity to be here today. 

As this Committee knows, EPA's mission is to protect human health and the environment. 

Ensuring that our citizens, and especially our children, are protected from exposure to unsafe 

levels of toxic chemicals and pollution or other environmental threats in their homes, schools, 

or communities by continually strengthening our chemical management regime is not only 

central to EPA's work, but is an area that EPA Administrator Jackson identified as one of her 

priorities for the Agency. As she noted in her own testimony to Congress, the public expects 

the government to provide assurances that chemicals which are ubiquitous in our economy, 

our environment, and our bodies have been assessed, using the best available science, and that 

unacceptable risks have been eliminated. 

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You have asked me here today to talk about PBTs in particular. PBTs are long-lasting 

substances that build up in the food chain and, at certain exposure levels, may be harmful to 

human health and the environment. Their persistent property means that they do not break 

down, 50 when they are released to the environment they remain, essentially unaltered, for 

months or years. With continued use and release, they build up in sediments and soil. PBT's 

also bioaccumulate, such that their concentrations increase as they go up the food chain from 

sediment, to aquatic insects, to fish, for example. It is this concentration in the food chain 

which, under certain circumstances, can cause adverse effects in humans, including 

reproductive defects, or in wildlife. Some PBTs are also susceptible to long range transport 

such that adverse effects can be found far removed from their site of production or use. 

Combined, these properties are what make EPA concerned not only with historical PBT 

chemicals, such as DDT and PCBs, but also with chemicals with similar properties entering 

commerce today or in the future. And so I would like to take a few minutes to just touch on a 

few of the relevant domestic and international actions we have taken with respect to PBTs. 

First, in terms of pesticides, the Agency has adapted its standard risk assessment 

methodologies to specifically address the particular needs of compounds that exhibit 

perSistent, bioaccumulative, and toxic characteristics. These refined methods are designed to 

account for the unique attributes of PBT chemicals and are applied on the basis of 

internationally-recognized screening criteria. These unique attributes include the highly 

persistent nature of PBTs in the aquatic and terrestrial environment, their rapid partitioning 

onto soils and sediments, their accumulation in aquatic and terrestrial food webs, and their 

movement over exceptionally long distances away from their application. The Agency has 

begun using these methods to address the potential long-term build up of these chemicals in 

the environment, their potential biomagnification in aquatic food webs, and their potential 

transport to remote regions such as the Arctic. 

Second, in terms of industrial chemicals, the Agency recently announced that our office 

completed and released an initial set of chemical action plans which outline potential steps to 

address chemical risks. The chemicals selected for action plan development were chosen on 

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the basis of multiple factors, including available hazard, exposure, and use information; 

potential concern for children's health; use in consumer products; presence in human blood; 

persistence, bioaccumulative, and toxic characteristics; and production volume. In fact, three 

of the first four chemical action plans, covering polybrominated diphenyl ethers (PBDEs), longchained perfluorinated chemicals, and short-chained chlorinated paraffins, include chemicals 

that are known internationally for their PBT characteristics. 

We are moving forward to implement the actions in those plans and are working to develop 

plans for other chemicals as well, which will be announced on a regular basis in the months 

ahead. Further, among an array of other activities that cover PBTs in our new chemicals 

program, EPA has developed a policy statement that provides guidance criteria for determining 

persistence, bioaccumulation, and toxicity, and advises the industry about our regulatory 

approach, including the evaluation criteria, review process, exposure/release controls, and 

testing strategy for potential new PBT chemicals. EPA has also developed a computerized tool, 

the PBT Profiler, to help evaluate whether chemical have characteristics of persistence, 

bioaccumulation, and toxiCity and has made this PBT Profiler available on an EPA website at 

www.pbtprofiler.net. Our regional office in Chicago also has a significant PBT program and our 

TRI program takes into account the importance or significance of PBT characteristics through 

lower thresholds for reporting requirements. In addition, PBTs are a major regulatory focus in 

the Agency's Great lakes Water Quality Initiative, finalized in 1995. All in all, the breadth of PBT 

actions throughout the Agency is indicative of the importance we place on protecting human 

health and the environment from exposure to such harmful substances. 

But given the very nature of PBTs, stand-alone action by anyone country is not enough. 

Depending on the exposure level, these substances can pose real health and environmental 

risks to U.s. citizens and to people around the world because they are used and released here 

and in other countries and many can travel long distances from their source. 

The global nature of many of these substances is why the Obama Administration identified the 

Stockholm Convention on Persistent OrganiC Pollutants, along with the Rotterdam Convention 

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on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in 

International Trade, as a priority treaty for u.s. ratification. The United States was instrumental 

in negotiating both the Stockholm Convention and the Rotterdam Convention, each of which 

contributes in its own way to a healthier global environment and to a healthier America. The 

Stockholm Convention on Persistent Organic Pollutants (POPs) prohibits or restricts the 

production, use, and release of chemicals that are toxic, persist in the environment for long 

periods of time, bioaccumulate as they move up through the food chain, and are transported 

long distances in the environment, often landing far from the sources where they are released. 

The reduction or elimination of these POPs sources will have significant benefit to the United 

States and other countries around the world by reducing exposures that adversely affect 

human health and the environment. 

The Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous 

Chemicals and Pesticides in International Trade (PIC) was developed to promote information 

exchange and informed risk-based decision-making in the global movement of hazardous 

chemicals and pesticides. The Convention empowers governments to make their own domestic 

science- and risk-based decisions in an informed manner and, with regard to listed substances, 

obligates Parties to ensure that such substances are not exported to Parties that have not 

provided their consent. Additionally, for certain substances considered banned or severely 

restricted in the exporting country, the agreement requires the exporting government to 

provide export notification to the importing government. This prior informed consent regime is 

particularly helpful and important to developing countries that lack the capacity to enforce 

their own regulatory deciSions. 

The POPs Protocol to the Convention on Long Range Transboundary Air Pollution (the LRTAP 

POPs Protocol), which is similar to the Stockholm Convention, also addresses substances that 

are toxic, persistent, bioaccumulative, and susceptible to long range transport. However, this 

Protocol is regional in nature, covering the Member States of the United Nations Economic 

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Commission for Europe, which includes, among others, the United States, Canada, the EU, 

Russia, parts of the former Soviet Union, and Eastern Europe. 

The United States has already taken some steps to address the risks posed by PBT substances 

generally, and specifically the risks posed by the PBT substances covered by the Stockholm 

Convention, the LRTAP POPs Protocol, and the Rotterdam Convention. But it is of utmost 

importance for the United States to take the final step and join these agreements. Full 

participation in these Conventions and this Protocol by the United States is of special 

importance, for example, for the people and environment of Alaska, which is impacted more 

than any other state by POPs transported by air and water from outside the United States. This 

is particularly true for Alaskan Natives, who, like many around the United States, rely heavily on 

traditional diets comprised of fish and wildlife. 

By joining with the rest of the world to phase out or reduce the use and release of these PBTs, 

we protect both human health and the environment, not only for ourselves, but for the rest of 

the world. At EPA, we take the risks posed by these substances to our environment and public 

health very seriously. We are internationally recognized for our sound scientific risk 

assessments and regulatory decision making, and other countries look to the United States to 

provide strong leadership in the area of chemical safety. Our actions are respected and often 

replicated in other countries across the globe. But we are hampered by our lack of 

implementing legislation. 

As your committee considers the issue of PBTs, I would stress the importance of implementing 

legislation that would allow the United States to join the stockholm Convention, the Rotterdam 

Convention, and the LRTAP POPs Protocol. Over the past few decades, the United States has 

negotiated and signed international agreements that have the goal of protecting human health 

and the environment from toxic chemicals, but has been unable to join these agreements due 

to our lack of domestic legislation. The Obama Administration thinks it is time to pursue U.s. 

ratification of these agreements. 

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As part of our efforts to strengthen the Agency's chemical management regime, we have, 

among other actions, released a set of Administration principles to help guide legislative reform 

and outlined a series of ongoing and planned activities to enhance the Agency's chemical 

management efforts. Much of that work will encompass PBT substances and could provide an 

opportunity for the consideration of implementing legislation for the Rotterdam Convention, 

the Stockholm Convention, and the lRTAP POPs Protocol. We look forward to working with 

Congress, our domestic stakeholders, and the international community to strengthen both our 

domestic and our international actions with respect to PBT substances. 

Thank you for having me here today and I'll be glad to respond to any questions you may have. 

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Mr. RUSH. The chair now recognizes Dr. Thompson for 5 minutes. 

STATEMENT OF JOHN E. THOMPSON 

Mr. THOMPSON. Thank you, Mr. Chairman, and my thanks to the 

members of the subcommittee for holding this hearing on domestic 

and international actions on PBTs. 

I have a written statement I would like to submit for the record 

with your permission. 

Mr. RUSH. Hearing no objection. 

Mr. THOMPSON. Thank you. 

The advances in the discovery and application of chemicals have 

led to many benefits enjoyed by society. At the same time, certain 

chemicals impose significant risks to human health and the environment. Production and use of such chemicals is increasing outside of the United States. That is important because of the potential for local harm and also because some chemicals are capable of 

having impacts far from where they are used and released. 

Indigenous people in Alaska and elsewhere in the United States, 

though often remote from such sources, may be particularly at risk 

to exposure because of their reliance on a subsistence diet. Of particular interest, are those PBTs which are organic and capable of 

transporting over long distances, these chemicals are referred to 

persistent, organic pollutants or POPs. We focus on these chemicals 

internationally because they can pose risks far from their source of 

release. The role of the State Department is to facilitate international cooperation aimed at mitigating these risks and we do so 

working closely with our colleagues from the Environmental Protection Agency. In that regard, I would like to describe three key 

international agreements aimed at controlling these types of chemicals, the Stockholm Convention on POPs, the Protocol on POPs on 

the Convention on Long Range Transboundary Air Pollution and 

the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade. 

The Stockholm Convention aims to protect human health and the 

environment from exposure to POPs. It has been ratified by 169 

countries including nearly all of our major trading partners and allies. The Convention calls upon parties to prohibit or restrict production in use of POPs such PCBs, and to reduce byproduct emissions of substances such as dioxins and furans. It includes a 

science-based procedure to govern the addition of chemicals and allows a party to decide whether to join amendments adding a substance to the Convention. 

The second agreement I would like to mention is the POPs Protocol to the Convention on Long Range Transboundary Air Pollution. This agreement is broadly similar to the global Stockholm 

Convention, but it is regional in nature, encompassing the United 

States, Canada, Europe and the former Soviet Republics. 

A third important agreement is the Rotterdam Convention which 

promotes shared responsibility between exporting and importing 

countries in the trade of certain chemicals. For international shipments of such chemicals, it stipulates that consent of the importing 

country must be obtained before the chemical can be exported. The 


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Convention helps to ensure countries have information to make decisions on sound chemicals management which means less likelihood of health and environmental risks in those countries and in 

the United States. 

These agreements have the support of this Administration and 

the business and environmental communities but we are a 

nonparty because we need legislation to fully implement their provisions. We are therefore unable as a nonparty to participate fully 

in their proceedings. Only by joining these agreements, can we use 

them effectively to pursue public health protection in the United 

States. What is of paramount interest to the Department of State 

is enabling full U.S. participation in the deliberation of these agreements as soon as possible so we can pursue U.S. interests, especially protecting public health and the environment. 

I also note that EPA recently announced the development of action plans to address certain classes of chemicals as potential priorities. Some of these chemicals are under consideration or are already included in the agreements that I have described. The best 

way for the United States to lead internationally is to do so based 

on a strong domestic approach that is consistent with our international obligations. By taking action at home, we can use these 

agreements to ensure chemicals are managed more responsibly 

abroad. 

In summary, Mr. Chairman, there are some chemicals whose use 

anywhere in the world may present a public health and environmental threat to the United States because they are persistent, bioaccumulative, toxic and are transported over long distances. We are 

most effective leading abroad when we have been diligent and effective in addressing chemicals management at home. We have the 

tools to promote better management of these chemicals on a global 

basis through these agreements but we need to join them to do that 

most effectively. 

Thank you for having me here today and I would be pleased to 

answer any questions. 

[The prepared statement of Mr. Thompson follows:] 


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WRITIEN TESTIMONY OF 

DR. JOHN E. THOMPSON 

DIVISION DIRECTOR 

BUREAU OF OCEANS, ENVIRONMENT AND SCIENCE 

U.S. DEPARTMENT OF STATE 

BEFORE THE 

SUBCOMMITIEE ON COMMERCE, TRADE, AND CONSUMER PROTECTION 

COMMITIEE ON ENERGY AND COMMERCE 

U.S. HOUSE OF REPRESENTATIVES 

March 4, 2010 

Thank you, Mr. Chairman, and my thanks also to the members of the Subcommittee for holding 

this hearing on domestic and international actions on persistent, bioaccumulative, and toxic 

chemicals. 

Advances in the discovery, production, and application of chemicals have been responsible for 

many benefits enjoyed by society all over the world. But as scientific knowledge of these 

substances has increased, we have learned that certain chemicals impose significant risks to 

human health and the environment. We also see a trend of growing production and use of 

chemicals in developing countries, which may lack fully developed regulatory systems to ensure 

sound management practices. We care about how other countries manage and use chemicals 

for at least two reasons: because of the potential for local harm, and because some chemicals 

are capable of haVing significant impacts far from where they are released. For example, the 

elevated levels of persistent organic pollutants (POPs) measured in Alaska and the Arctic, far 

from where they are used or produced, make it clear that poor management abroad can lead to 

human health and environmental risks at home. 

The set of chemicals we are talking about today chemicals that persist in the environment, 

bioaccumulate in organisms, and are toxic - are being focused on because of their intrinsic 

characteristics. Of particular concern is a subset of these chemicals which are organic and 
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capable of transporting over long distances; these chemicals are often referred to as POPs. It is 

these chemicals in particular we are focusing on internationally because they can pose risks to 

public health and the environment in countries far from the source of production or use. While 

the United States and many developed countries stopped using these chemicals many years 

ago, they can still present a threat to the health of our population because of their continued 

use in other countries today. Indigenous people in Alaska and elsewhere in the United States 

may be particularly at risk to exposure because of their reliance on a subsistence diet. Through 

our global efforts of collaboration and cooperation, we can seek to improve standards for the 

management of chemicals and raise environmental protection in other countries to a level that 

will benefit their public health as well as ours. The role of the State Department is to work with 

other countries to facilitate this type of cooperation, working side by side with our colleagues 

from the Environmental Protection Agency. 

For these reasons, international cooperation is not only desirable, but vitally necessary to 

protect public health and the environment in the United States. I would like to focus on three 

key international agreements aimed at controlling the types of chemicals that are the subject of 

this hearing. The three agreements are the Stockholm Convention on Persistent Organic 

Pollutants, the Protocol on Persistent Organic Pollutants of the Convention on Long Range 

Transboundary Air Pollution (LRTAP), and the Rotterdam Convention on the Prior Informed 

Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade (PIC). 

The Stockholm Convention aims to protect human health and the environment from chemicals 

that are of particular concern because of four intrinsic characteristics: they are toxic, they 

bioaccumulate in humans and animals, they are resistant to natural breakdown, and they have 

the potential to be transported over long distances. The twelve POPs initially covered by the 

agreement are: aldrin, hexachlorobenzene, chlordane, mirex, DDT, toxaphene, dieldrin, 

polychlorinated biphenyls (PCBs), endrin, heptachlor, dioxins and furans. None of these twelve 

chemicals is now used or manufactured in the United States, but they are still used in some 

parts of the world. Sale and use of DDT, for example, has been banned domestically since 1973, 

but continues to be used in other countries as an antifoulant in paint when alternatives to that 

use already exist. Through international cooperation we can put an end to these unnecessary 

uses of POPs. 

The Stockholm Convention entered into force on May 17, 2004, and has been ratified by 169 

countries, including nearly all of our major trading partners and allies. It calls upon countries to 

prohibit or restrict production and use of POPs such as PCBs, and to reduce byproduct 

emissions of chemicals like dioxins and furans. It includes a science-based procedure to govern 

the addition of chemicals to the Convention. This procedure includes a review process which 

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considers criteria for inclusion of chemicals of global concern, as well as socio-economic aspects 

of the use of these chemicals. This is the procedure used to add nine new substances to the 

Convention in May, 2009: hexabromobiphenyl, hexa- and hepta-bromodiphenyl ether, lindane, 

pentachlorobenzene, perfluorooctane sulfonic acid, tetra- and penta-bromodiphenyl ether, 

chlordecone, and alpha and beta hexachlorocyclohexane. While the Parties continue to 

consider additional substances for inclusion in the Convention's scope, the Convention includes 

provisions that allow a party to affirmatively decide whether to join amendments adding new 

substances to the Convention. Therefore, should the United States join the Convention, we can 

utilize this provision to ensure that we only take on obligations to address further chemicals if 

we affirmatively agree to do so. 

The second agreement I would like to describe is the POPs Protocol to LRTAP, which entered 

into force on October 23, 2003, and has 29 Parties. This agreement is broadly similar to the 

global Stockholm Convention, but it is regional in nature, encompassing the United States, 

Canada, Europe, and the former Soviet Republics. The POPs Protocol initially included sixteen 

substances, and in December 2009, it was amended to add 7 additional substances to its scope. 

Like the Stockholm Convention, the LRTAP POPs Protocol is structured to ensure the United 

States would only take on obligations to address further chemicals if we affirmatively agree to 

do so. 

Another important agreement is the Rotterdam Convention on the Prior Informed Consent 

Procedure. The Rotterdam Convention promotes shared responsibility between exporting and 

importing countries in the trade of certain chemicals and pesticides. It entered into force on 

February 24, 2004 and has been ratified by 131 countries. The Convention currently lists 40 

chemicals, many of which are the same chemicals considered to be POPs. For international 

shipments of the chemicals listed, the Convention stipulates that prior informed consent of the 

importing country must be obtained before the chemical can be exported to that country. 

Many countries simply lack the capacity to either control their borders, or lack a fully effective 

regulatory system that ensures their proper use. The Rotterdam Convention helps to ensure 

they have full information to make decisions on the sound use and management of chemicals 

within their own domestic environments. Better management of harmful chemicals in other 

countries means less likelihood of public health and environmental risks in those countries and 

in the United States due to their unnecessary release into commerce and the environment. 

The United States participated actively in the negotiation of each of these agreements, and has 

supported them through multiple administrations. We have vital interests at stake in 

protecting public health and the environment in the United States, and the tools available to us 

in these agreements can be used to galvanize global efforts aimed at controlling their 

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production and use. While these agreements enjoy the support of this Administration, the 

business community, and environmental organizations, we are currently not a party to any of 

them. The United States has taken some domestic action related to most of the listed 

substances, but we would require legislation to fully implement the obligations of the 

agreements. Meanwhile, as a non-Party, the United States is unable to participate fully in the 

political or technical aspects of their proceedings and contribute to the process as the 

agreements evolve over time and add additional chemicals to their scope. By joining these 

agreements the United States will be able to take on the role befitting our status as a leader in 

environmental protection, and be able to use them effectively to pursue public health 

protection in the United States. 

I would also like to emphasize the importance of the connection between the domestic and 

international aspects of the control of persistent, bioaccumulative and toxic chemicals. EPA has 

recently announced the development of chemical action plans to address certain classes of 

chemicals as potential priorities because they may present risks to human health and the 

environment. In some cases, the chemicals on which EPA is focusing are also the subject of 

international attention. Short-chain chlorinated paraffins (SCCPs) are an example of such a 

group of chemicals for which EPA has developed an action plan, and at the same time, has been 

proposed for listing in the Stockholm Convention and already been added as an amendment to 

the lRTAP POPs Protocol. And this isn't the only example. Several of the chemicals EPA is 

focusing on are included or are under consideration for inclusion under the Stockholm 

Convention. The best way for the United States to lead internationally, is to do so based on a 

strong approach at home that is risk-based and consistent with our international obligations. 

Development of action plans or other effective domestic approaches to address these 

chemicals allows us to promote sound, risk-based management approaches in other countries 

through these international agreements. When we have taken strong action at home, the 

United States has been very successful in mobilizing political will in other countries to ensure 

chemicals are managed in a more environmentally sound manner. 

We are very pleased at the attention being paid in Congress to the need to undertake a 

comprehensive and thoughtful review of one of our domestic laws as a part of possible changes 

to the Toxic Substances Control Act (TSCAl. The particular approaches and technical issues 

involved in this legislation are outside of my area of expertise so the Department of State will 

not express views on these matters. What is of paramount interest to the Department of State 

is enabling the full participation of our government in the deliberations that take place under 

the international Conventions I have described as soon as possible, because their evolution 

impacts vital U.S. interests, especially protecting pUblic health and the environment for u.s. 

citizens. The sooner the United States takes a seat at these tables, the sooner we will be 

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ensured that we have a voice as further changes to the agreements are contemplated, for 

example the addition of chemicals to their scope. Our participation will significantly help 

international efforts to address the types of chemicals that are the subject of this hearing. For 

these reasons, it is vital that we move forward quickly to join these agreements. 

In summary, Mr. Chairman, there are some chemicals whose use anywhere in the world may 

present a public health and environmental threat to the United States because they are 

persistent, bioaccumulative, toxic, and are transported over long distances. We have the tools 

to promote better management and safer alternatives to these chemicals on a global basis if we 

join these international agreements and utilize them to elevate other countries to our level of 

environmental protection. We are most effective leading abroad when we have been diligent 

and effective in addressing chemicals management at home first. This hearing is a sign of a 

renewed domestic interest in pursuing improved sound chemicals management at home, which 

I hope can facilitate our further efforts abroad aimed at the same goal of public health and 

environmental protection in the United States. We need to join these key Conventions to do 

that most effectively. I thank the Subcommittee for holding a hearing on this important issue, 

and I would be pleased to answer any questions the subcommittee might have. 

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Mr. RUSH. Thank you, Dr. Thompson. 

Mr. Sturdevant, will you please hold your testimony until we return? The committee stands in recess until 11:30. 

[Recess] 

Mr. RUSH. Dr. Greer, are you prepared with your opening statement? 

Ms. GREER. Yes, sir. 

Mr. RUSH. All right, well, the chair recognizes Dr. Greer for 5 

minutes for the purposes of an opening statement. 

STATEMENT OF LINDA E. GREER 

Ms. GREER. Thank you for the opportunity to testify today. 

I am Linda Greer and I am the director of the Health Program 

at NRDC, the Natural Resources Defense Council. I have a Ph.D. 

in environmental toxicology and a masters degree in public health. 

Since 1981, I have worked on a wide range of environmental health 

issues, and have focused on numerous persistent, bioaccumulative 

and toxic chemicals including mercury, dioxin and PCBs, among 

others. 

Commonsense tells us that chemicals with a PBT profile are bad 

actors and that laws designed to protect people from dangerous environmental contaminants should prioritize the phase-out of chemicals with this alarming profile. Society should rely upon safer 

chemicals that will degrade and be metabolized easily in the body 

back into harmless chemicals after use, not those that will take 

shelter in our bones, in our blood and in our fat for the rest of eternity. 

Remarkably, however, PBTs are not a thing of the past. Despite 

the notoriety of this class and all that scientists have learned about 

them over the past 30 years, there are still many such chemicals 

that continue to be used in commerce today and sometimes in very 

large quantities. Three of EPA’s four recently announced chemical 

action plans, for example, are from the PBT class. 

The polybrominated diphenyl ethers, the PBDEs, are still used 

today as flame-retardants in plastics, polyurethane foams and textiles, even though safer alternatives are available. They remain in 

products in millions of homes. This, despite the evidence that their 

chemical structure is extraordinarily similar to the PCBs banned 

decades ago that they share structural characteristics of the 

dioxins. 

Despite the toxicological evidence that shows that PBDEs are 

thyroid hormone disrupters, that they are neurotoxic to the developing brain, and that they have immunotoxic properties similar to 

PCBs; despite the doubling of their concentration milk samples 

every 5 years; despite their detection globally, including in the arctic where they have never been used, PBDEs are still in use in 

2010. And other PBDEs are similarly still in the market and used 

in high volume despite all that we know about the hazards they 

pose, defying commonsense. 

So how can this be? It is truly a tribute to the utter impotence 

of TSCA that chemicals with such notorious profiles remain on the 

market allowing the public to be endlessly exposed while analysis 

after analysis lumbers on. TSCA constraints make it very difficult 

for EPA to fully assess new chemicals or require the testing of 


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chemicals in use, and the hurdles for EPA to actually restrict use 

of an existing chemical are even higher. It is almost impossible for 

EPA to take regulatory action against PBTs and other dangerous 

chemicals, even those like asbestos that are well-known to cause 

cancer or other serious health effects. And although some in industry see the problems and agree that we need reform, many others 

are comfortable with the culture or study and delay that have kept 

EPA from taking action on chemicals they have marketed without 

safety data for more than a generation. 

This head-in-the-sand mentality is not good for business in the 

long run. Europe is far ahead of us and will prohibit the export of 

these chemicals to their markets. Safety problems will plague these 

companies eventually as the latest story from Toyota shows us. 

The consequence of such delay in getting PBTS and other dangerous chemicals off the market may well have had a personal impact on me. Three years ago as I continued my career to reduce 

toxic chemical pollution, I got a call from my doctor about an abnormality in my mammogram. Soon afterwards, I was struggling 

to come to terms with the diagnosis every woman dreads, breast 

cancer. Despite my Ph.D., I found myself thinking what everyone 

thinks in a situation like this, why did this happen to me, and not 

just why me but why so many colleagues and friends. The president of NRDC, Frances Beinecke, was diagnosed with breast cancer 

about 8 years ago. So was the executive assistant of John Adams, 

our former president. She died of that disease before the age of 45, 

a woman in our finance department, another in communications, 

one of our senior analysts, an office manager, a young temporary 

secretary, my sister-in-law. Most or all of these women did not 

have known risk factors and all of them contracted this disease 

when they were very young. 

I suspect many of the members of this committee, and their staff, 

have had similar experiences. Friends, family and colleagues who 

have been diagnosed with cancer, or who have children with infertility issues, or grandchildren with development or learning disabilities, or elderly parents with Alzheimer’s or Parkinson’s disease. 

I tell my story to inspire you, this committee, this Congress and 

this Administration to seriously consider what it will take to get 

action on hazardous chemicals still being used in commerce today, 

known PBTs and others. Not just testing. Not just information. Not 

more analysis, action. Well known PBTs, such as dioxin, DDT and 

PCBs have been associated with the risks of breast cancer for 

many, many years. A survey of peer review literature found more 

than 200 chemicals has been associated with mammary tumors in 

animals. Chlorinated solvents, polynuclear aromatics and others, 

yet EPA has taken action on only four of 80,000 chemicals in commerce in the 35 years of TSCA. 

The public is rightfully alarmed and wants to see action and results not just more years of studies that lead nowhere. Many retailers have themselves taken action to remove products from shelves 

where they fear harm to their customers in light of government 

stagnation. Even certain segments of industry itself, the personal 

products manufacturers, for example, who manufacture our lotions 

and shampoos, have begun to speak out for the need for reform 


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fearing problems in the ingredients that they buy for their formulation. 

For this reason, we recommend Congress and this committee, 

mandate the phase-out of at least the handful of best known PBTs 

and bad actors in a reauthorized TSCA and put our country on a 

path forward for the use of safer chemicals. We have spent literally 

decades quantifying the risks of these chemicals and exposed an 

entire generation in the meantime, unable to turn to the more 

practical questions of how these PBTs are used, how they can be 

reduced, how they can be phased out. It is time for EPA to parse 

the uses, identify the critical uses, identify the unnecessary uses, 

and move forward on these chemicals. 

I was one of the lucky ones. My breast cancer has been caught 

early and I am doing well but as I do my work every day, I think 

of my daughter who was dosed with every contaminant in my 

breast milk four or more times a day for the first year of her life 

and of her generation. My efforts here today and back at the desk 

to reduce or eliminate toxic chemicals are for her, and you too 

should take action to protect your children and grandchildren. 

Thank you very much for this opportunity to testify. 

[The prepared statement of Ms. Greer follows:] 


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TESTIMONY OF 

LlNDA E. GREER, Ph.D 

DIRECTOR, HEALTH AND El\TVIRONMENT PROGRAM 

ON BEHALF OF: 

NATURAL RESOURCES DEFENSE COUNCIL 

BEFORE THE U.S. CONGRESS 

COMMITTEE ON ENERGY AND COMMERCE 

SUBCOMMITTEE ON COMMERCE, TRADE AND CONSUMER PROTECTION 

AT HEARlNG ENTITLED: 

TSCA AND PERSISTENT, BIOACCUMULA TIVE, AND TOXIC CHEMICALS: EXAMINING 

DOMESTIC AND INTF.RNATIONAL ACTIONS 

MARCH 4,2010 
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Thank you for the opportunity to testify today. My name is Linda Greer, and I am the Director of the 

Health Program at NRDC (the Natural Resources Dcfense Council). I have a Ph.D. in environmental 

toxicology and a masters degree in public health. Since 1981, I have worked on a wide range of 

environmental health issues, including Federal policies for assessing hazardous chemicals, pollution 

prevention opportunities in U.S. and Chinese manufacturing plants, and global mercury use reduction. My 

work and rescarch has focused on numerolls persistent, bioaccumulative and toxic chemicals, including 

mercury, dioxin, and PCBs, among many others. As I scientist, I know that PBT chemicals should be a 

high priority for use and exposure reduction because failure to act will result in ever-increasing 

contamination, not just of the enviromnent, but also of our bodies. 

PBTs are uniquely dangerous because once they are released into the environment (intentionally or 

accidentally), they don't go away. They linger for years or even decades, accumnlating and increasing in 

concentration over time. PCBs, the only chemicals banned by Congress under the original TSCA, 

similarly continue to plague both our environment and our bodies. Although levels ofPeBs have 

gradually declined over the past 3 decades, these chemicals can still be found lingering in the blood of 

nearly everyone in the U.S. Rachel Carson warned about the dangers of persistent chemicals, saying: 

"This pollution is for the most part irrecoverable; the chain of evil it initiates ... is for the most part 

irreversible."l 

As if persisting for more than 30 years were not enough, PBT chemicals also increase in concentration in 

living things over time as they move up the food chain - the "8" property of their PBT classification: 

bioaccumulation. This means that even low concentrations in environmental media (such as air, water, or 

soil) can lead to levels hundreds or thousands of times higher in living things. Bioaccumulation is the 

reason that 43% of the Nation's total lake acreage and 39% of the nation's total river miles in a1150 states 

now carry fish advisories warning against consumption due to contamination with persistent chemicals 

such as mercury, PCBs, and dioxin (Figure 1),;; 

The combined properties oftoxicity, persistence and bioaccumulation make quantifying the threat posed 

by these chemicals extremely challenging. It is not enough to look simply at existing concentrations in 

air, water, sailor sediment, to evaluate the harm they posc; one must consider that concentrations will 

continue to rise over time and only decrease very slowly, perhaps taking decades or longer. Similarly one 

must look beyond environmental concentrations to the concentrations at the top ofthe food chain for PBT 

chemicals in order to evaluate effects. Here again, existing concentrations are not necessarily at 

equilibrium; with or in some cases even without continued loading, they too will contitme to rise over 

time and not go away. The tool that EPA and others use to quantify the harm that chemicals pose - risk 

assessment - is in fact an inadequate tool for evaluating the harm posed by PBTs for this reason. Because 

risk assessments require a quantification of exposure levels, and because the levels of PBTs will continue 

to rise for as long as the contaminant is released into the environment of the food chain, they cannot 

adequately evaluate tbe harm posed by this class of compounds. 

The application of risk assessment to PBTs is further limited due to the complex movement ofPBTs 

through multiple levels of the food web and the long distance transport of PBTs throughout the global 

environment For these reasons, using risk assessment to determine which uses of PBTs should be 

reduced or eliminated, and to what extent, is fraught with difficulty. Many layers of added uncertainty 

result, severely limiting the predictive value of such judgments when risk assessment is applied to PBTs. 

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Common sense tells us that chemicals with a PBT profile are bad actors, and that a law or policy designed 

to protect people must phase out the use ofPBTs and require the use of safer chemicals that degrade 

easily back into harmless chemicals when treated or discharged into the environment, rather than 

sequestered in our bones, blood or fat deposits because they cannot be degraded, 

It is instructive to look historically at the evaluation of the toxic properties of PCBs to understand why 

risk assessment doesn't work well for this class of chemicals, Initial small studies of adult male workers 

done in the 1 960s did not detect dramatic health effects, so the chemicals were initially touted as 

relatively nontoxic and the fact that they were persistent and accumulated in fat was not considered a 

problem.iii Over the decades, larger and more detailed studies on young children have shown that PCBs 

are neurotoxic, and have anti-thyroid and immunotoxic effects,iv These health effects occur at low doses 

at levels that many people who consume fish from the Great Lakes and other areas today have in their 

bodies. But by the time the newer, much more complex and expensive scientific studies were done, it was 

too late - significant damage was already done because PCBs had persisted and accumulated in the 

environment, contaminating the entire food web. 

PCBs were banned outright by Congress in 1976 (one of the few successes of the Toxic Substances 

Control Act), In 1978, the United States entered into the binational Great Lakes Water Quality Agreement 

with Canada, which called for the virtual elimination of persistent toxic chemicals to protect human health 

and the aquatic environment. Less than two years ago, Congress overwhelmingly voted to ban the export 

of mercury from the U.S, - an important step toward an international treaty to substantially reduce 

mercury in commerce and significantly curb emissions and thereby protect our food supply. 

Unfottunately it will take many more decades before the damage fi'om these persistent chemicals begins 

to subside. 

The history of persistent, bioaccumulative and toxic chemicals has created a compelling case for 

prevention"Many scientists have pointed out that waiting for clear evidence of harm from these chemicals 

is tantamount to closing the proverbial barn door long after the animals have scattered far and wide. If wc 

fail to act to,rcduce or eliminate chemicals in use today that are likely to be the PCBs, dioxins, and 

mercury of the future, then future generations will be faced with the realization that the food they eat is 

tainted by health dangers. 

Despite the notoriety of PBT chemicals, there are many such chemicals that continue to be used in 

commerce today -and sometimes in very large quantities. For example, some of the polybrominated 

diphenyl ethers (PBDEs) are still used as flame retardants in plastics, polyurethane foams, and textiles 

even though safer alternatives are available. While some PBDEs are no longer used, they remain in 

products in millions of homes. The chemical structure of the PBDEs is extraordinarily similar to the 

PCBs, and these chemicals also share structural characteristics of the dioxins. In fact, the toxicologic 

evidence shows that the PBDEs are thyroid hormone disruptors, that they are neurotoxic to the developing 

brain, and that they have immunotoxic properties similar to the PCBs.' 

The PBDEs are environmentally persistent and bioaccumulate rapidly, Levels ofthe PBDEs doubled 

every five years in breast milk samples from Sweden, and residues ofthese chemicals have been detected 

globally including in the arctic, where they have never been used,'i Several U.S, states, including 

California, Illinois, Maryland, Michigan, Minnesota, Maine, New York, and Washington have restricted 

major uses of PBDEs based on their inherent properties as PBTs without attempting to apply ineffective 

risk assessment methods to the task. 

EPA has announced plans to take more additional, although limited, action on these chemicals, and 

urgently requires additional Congressional authority to take immediate action on persistent chemicals 

such as the PBDEs, Meanwhile many other chemicals are also turning ont to be persistent, 

bioaccumlative and toxic: the di-, trio, tetra- and pentachlorobenzenes, hexachlorobutadiene, other flame 

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retardants such as tetrabromobisphenol A and HBCD, and PFOS, and the musk xylenes, to name only a 

few. All of these chemicals require decisive action, not years of additional study while the levels in the 

food supply creep upward. 

Scientific and regulatory consensus definitions for persistent, bioaccumulative, and toxic chemicals 

already exist These criteria are not particularly controversial, and it makes sense for Congress to simply 

state that, as a matter ofV.S. policy, with narrow exceptions, new chemicals with these properties should 

not be introduced into commerce. Similarly, PBT chemicals that are currently in commerce should be 

phased out, allowing, of course, for exemptions for essential uses for which no alternatives yet exist. 

Before I close, I would like to mention that the hazards posed by PBTs are very personal for me. Three 

years ago, when I was doing work to reduce global mercury use and pollution, I got a call from my doctor 

about an abnormality on my mammogram. Soon afterward, I was struggling to come to terms with the 

diagnosis every wOlllan dreads - breast cancer. I have to tell you, it really threw me for a loop. I found 

myself thinking what everyone thinks in a situation like this - why did this happen to me? I don't have 

many of the conventional risk factors for breast cancer, but I'm not alone. Most of tile women with this 

disease don't have known risk factors. 

One difference between me and many other women with breast cancer is my familiarity with the science. 

r know that in the United States between the 1970's and 2000, breast cancer incidence rates increased by 

more than 40 percent. As of2008 a woman's lifetime risk of breast cancer in the U.S. was one in eight. 

I also know that the belief that breast cancer is mainly a genetic disease is unfounded. In July of 2000, a 

Scandinavian study of nearly 45,000 twins published in the New England Journal of Medicine tried to 

separate out genetic vs. environmental factors in cancer. The bottom line of this important study was that 

the vast majority of cancers are environmental rather than genetic. In the case of breast cancer, only about 

one-quarter of the risk is due to inherited factors; that leaves the remaining risk of breast cancer linked to 

environmental factors. 

There are numerous known or suspected environmental toxicants that have been linked to breast cancer. 

In fact, a 2007 study identified 216 chemicals that have been shown to cause cancers of the mammary 

gland in animals.'" Worse still, after more than three decades since the establishment of EPA, only a 

small handful of tile tens ofthousands of chemicals on the market have been evaluated for their ability to 

cause this terrible disease. 

Numerous chemicals that have been linked to breast cancers in animals and humans are PBTs, including 

now-banned pesticides such as dieldrin, aldrin, and heptachlor, as well as the PCBs and dioxins. It's no 

surprise to a toxicologist like myself that these chemicals might he linked to breast cancer -- since they 

accumulate in fat cells, and are known to concentrate in breast tissue and even breast milk. Just this fall, 

an updated study on women exposed to dioxin from a 1976 industrial accident in Italy reported a 

statistically significant increased risk of breast cancer (by morc than 2.5-fold) in dioxin-exposed 

women.~;i Meanwhile EPA began an assessment of the health risks of dioxin in J 985, and 25 years later 

has still not completed the work. 

As great as the problems posed by these historical examples of persistent, bioaccumulative carcinogens 

are, this Committee, Congress, and the Administration, should be thinking seriously about how to address 

chemicals that are still being used in commerce today, that are known to have these same properties of 

persistence and bioaccumulation. These are chemicals that are nol only used for industrial purposes like 

PCBs in transformers. We are talking about PBT chemicals used in everyday products that people have 

in their homes - in their furniture, in their computers, in their cookware. From there, PBT chemicals can 

easily make their way into Ollr breast milk, our food, and our bodies. Congress must take responsible 

action to phase out the use of PETs and put our country on a path toward use of safer chern icals. When 

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chemicals accumulate rapidly, and then linger on for generations, we don't have the lUxury to engage in a 

lengthy research study or prolonged risk assessments. It should simply be a matter of common sense 

policy that manufacturers n1ust, where feasible, switch to alternative chemicals that are not persistent and 

do not bioaccumulate. 

J was one of the lucky ones. My breast cancer was caught early and I am doing well. But as I do my work 

every day, I think of my daughter .. who received whatever contaminants I had in my breast milk when I 

nursed ber -- and of her generation. My efforts to reduce or eliminate toxic chemicals are for her. We 

must protect the ncxt generation by creating responsible and effective chemical policy today. 

Thank you for this opportunity to testifY. 

Figure 1: Fish Advisories for PST Contamination in the United States 

50.0-.------------------~--------------___. 

45.0 

~ 40.0 

<: ... 35.0 o 

\II 

..9:! 30.0 

f 

---.--.-~ .. -~---~--.... -.--.--.---------.-.----"------."- _. --"------------

II River Miles 

II Lake Acres 

] 25.0 .~-.-.. - .. ----~ .. --~-.--------... -

~ 

~ 20.0~J_ l: 15,0 --

~ 

10.0 j 

I 5.01 

0.0 

1993 1994 1995 19% 1997 1999 1999 1000 2001 2002 2003 2004 2005 2006 1007 200S 

Year 
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i Carson R. Silent Spring. Boston: Houghton Mifflin Company, 1962;6. 

ii http://www.epa. >!ov/watersc iencelfish/advisories/tech2008 .hlm 1 

iii Ouw HK, Simpson GR, Siya\i DS. Use and health effects of Aroclor 1242, a polychlorinated biphenyl, ir 

electrical industry. Arch Environ Health 1976;31:189-94. 

iv Birnbaum L. Developmental effects of dioxins and related endocrine disrupting chemicals, Toxicol Lett 

1995;82/83:743-750. 

v Eriksson P, Iakobsson E, Fredriksson A. Brominated flame retardants: A novel class of developmental 

neurotoxicants in our environment? Environ Health Perspect 2001;109:903-908. 

vi Ikonomou M, Rayne S, Addison R. Exponential increases ofbrominated flame retardants, polybrominate 

diphenyl ethers, in the Canadian Arctic from 198] to 2000. Environ. Sci. Techno!. 2002;36:1886-1892. 

vii Rudel RA, Attfield KA, Schifano IN, Brody JG. Chemicals causing mammary gland tumors in animals, 

new directions for epidemiology, chemicals testing, and fisk assessment for breast cancer prevention. Cane, 

Issue S12: 2635-2666,2007. 

viii Pesatori AC, Consonni D, Rubagotti M, Grillo P, Bertazzi PA. Cancer incidence in the popUlation expo 

dioxin after the "Seveso accident": twenty years offollow-up. Environ Health. 8:39,2009. 

6 
44 

Mr. RUSH. The chair now recognizes Dr. Cowan-Ellsberry. 

STATEMENT OF CHRISTINA COWAN-ELLSBERRY 

Ms. COWAN-ELLSBERRY. First, I would like to thank the chairman and the ranking member and the members of the subcommittee for inviting me to testify before you today. 

My name is Christina Cowan-Ellsberry and I have worked in the 

field of environmental and human safety and risk assessment of 

chemicals for over 30 years. I am here of my own volition and represent only myself. My testimony is based on my scientific training 

and expertise and my experience with the PBT issue. There are 

two reasons I decided to come on my own. First, as a consumer and 

citizen of the United States, I am as concerned as you are about 

chemicals that may be in commerce and that could cause adverse 

impacts on me, my family and the environment. 

Secondly, I have worked since the 1990s, and actually earlier, on 

the development of the PBT criteria and methods for identifying 

and evaluating the safety of organic PBTs in several national and 

international fora, including the United States, Canada, Europe 

and the United Nations. I have seen how using the established criteria, and science and risk-based assessment process has resulted 

in effective PBT identification and assessment programs, and has 

resulted in prioritization of resources toward PBT management on 

national and global scales. As successful as these initiatives have 

been in illustrating it is possible to identify, assess and manage 

PBTs, these initiatives have also illustrated that the process can be 

scientifically challenging, and require the active involvement of the 

best scientists and the use of the most reliable and relevant data. 

At the recent SETAC Pellston Workshop, one common frustration 

voiced by participants was that many of the current national and 

international regulations accept only a limited set of test data. 

While this may be appropriate for screening and prioritization, it 

fails to recognize the incredible evolution of the science which has 

produced new insights into PBT chemical and an array of new 

methods to identify and assess PBT chemicals. As a result, the scientists are frustrated when they bring forward these new data and 

insights only to find that they are rejected, not because of scientific 

reasons but rather because the regulatory framework does not 

allow for its consideration. Given the rapid improvement in these 

test methods and guidance, it is critically important for U.S. EPA 

scientists to contribute to and incorporate the most current science 

and scientific understanding into their assessments. 

Through all my years of work on PBTs, I have greatly valued the 

scientific expertise and interaction with my colleagues in the U.S. 

EPA, and commend them for their role in promoting the risk-based 

and science-based underpinnings of the PBT identification and assessment process. My concern is, and as voiced by several here, is 

that although the U.S. publicly committed in the 1990s to working 

within the international community to address chemicals of international concern, the U.S. has not become a full party to either the 

LRTAP POPs Protocol or the Stockholm POPs Protocol. Unfortunately, the risk-based and science-based underpinning of these two 

conventions, which the United States promoted are being eroded 

without this active U.S. involvement. I strongly urge you to make 


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45 

sure that the U.S. becomes a full party to these conventions so that 

the U.S. government scientists can once again bring their knowledge and expertise forward in leadership internationally. 

Finally, I believe it is also important that EPA develop a stronger Federal PBT program so that the States do not have to take separate, and potentially conflicting, actions to identify and manage 

these substances. Many States don’t have the depth in scientific expertise nor the number of staff to effectively conduct these scientifically challenging assessments on their own. To ensure a technically strong and coordinated process for identification, assessment and management of PBTs, this program should include a scientific, multi-stakeholder fora, that includes representatives from 

these States, as well as potentially other scientific advisory panel 

members. Ultimately, I believe that a reform of TSCA that contains 

a strong commitment to and adequate funding for this Federal program of PBT identification, assessment and management, and U.S. 

leadership internationally in PBT conventions, will benefit U.S. 

citizens as it will contribute to improving global public health and 

the environment through managing existing PBT chemicals, and 

provide assurance that new chemicals that have PBT properties 

will not enter commerce. 

And once again, I thank you for this opportunity to testify today 

and I look forward to answering your questions. 

[The prepared statement of Ms. Cowan-Ellsberry follows:] 


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WRITTEN TESTIMONY OF CHRISTINA COWAN-ELLSBERRY, PH.D. 

To the Subcommittee on Commerce, Trade, and Consumer Protection Hearing on 

"TSCA and Persistent, Bioaccnmulative, and Toxic Chemicals: Examining Domestic and 

International Actions" 

March 4,2010 

I would very much like to thank the Chairman. Mr. Rush. Ranking Member. Mr. Whitfield and 

Members of the Subcommittee for inviting me to testify before you today. My name is Christina 

Cowan-Ellsberry. I have a Ph.D. in Civil Engineering with emphasis in Environmental 

Engineering. 1 have worked in the field of environmental and human safety and risk assessments 

for chemicals for over 30 years. Because I was invited as a tcchnical witness to this hearing on 

Persistent. Bioaccumulative and Toxic Substances (PBTs) in TSCA. I thought it would be 

relevant for this committee to understand my background on this topic. 

I have workcd on the development of the technical criteria and process for identifying and 

evaluating the safety of PBTs since the 1990s. I was a technical contributor to the Canadian 

Toxic Substance Management Policy criteria and assessment approach, and to their technical 

guidance documents on how to determine if a substance under evaluation meets the Persistence. 

Bioaccumulation and/or Toxicity criteria. I contributed to the technical criteria and process for 

UN Economic Cooperation for Europe's (UNECE) Persistent Organic Pollutants (POPs) 

Protocol to the Long-Range Transboundary Air Pollution (L.RTAP) C011\'cntion and the NAFTA 

Commission for Environmental Cooperation's Sound Management of Chemicals Initiative both 

of which contain PBT assessmcnts. I served as a representative to the Criteria Expert Group for 

the UN's Stockholm Persistent Organic Pollutants Convention. I have also contributed technical 

comments to the REACH implementation approach for PBTs. On a detailed scienti1ic level. I 

have organized and been a key contributor in several technical workshops and discussion groups 

both nationally and internationally on various aspects of the science and approaches to 

identifying and evaluating PBTs. This included the most recent Society of Environmental 

Toxicology and Chemistry'S Pellston Workshop whose goal was to improve the process of 

identification and evaluation of chemicals against the PBT criteria. Furthermore. I am the 

chairperson for the International L.ife Sciences Institute's Health and Environmental Sciences 

lnstitute (liES I) Bioaccumulation Project Committee whose mission is to develop the tools 

needed for improving the assessment of the potential bioaccumulation of organic substances. In 

all of these activities. I have worked with staff from the US EPA. You can see from this brief 

summary of my background that I have both a comprehensive knowledge of the technical basis 

for the criteria, identification and assessment of Persistent. Bioaccumulativc and Toxic (PBT) 

substances and the subcategory of organic PBTs called Persistent Organic Pollutants (POPs)s. In 

addition, I understand the goals of the various global PBT programs and how these lead to 

apparent differences in criteria and consequences. 

INTERNATIONAL PROGRAMS HAVE BEEN ADDRESSING PBT'S FOR SEVERAL 

DECADES. PBT identification and assessment for new and existing chemicals has been a 

priority of governments including the United States since the early 1990s. The first national 

regulatory effort to establish criteria and a process to identify PBT substances was Environment 
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Canada's Toxic Substance Management Policy (TSMP). which was published in 1995 1

• An 

integral part of this policy was development and publication of the tirst set of screening criteria 

for identifying if a substance was persistent and/or bioaccumulative. The objective oflhe policy 

and its associated criteria was to provide a framework for making science-based decisions to 

identify and prioritize PBT substances for risk assessment and potcntialmanagement. This 

scientific framework and criteria for Persistence and Bioaccumulation were also incorporated 

into the NAFTA CEC's Sound Management of Chemical's initiative (implemented in 1995)2 and 

the UN ECE's Persistcnt Organic Pollutants protocol within. their Long-Range Transport and 

Persistence (LRTAP) Convention (Entered into force 2003)". Within the UN ECE POP's 

protocol, the persistence criteria for water and sediment were reduced slightly from those 

included in the TSMP. These tinal set of criteria for Persistence and Bioaccumulation were 

eventually incorporated into the UN Stockholm Convention on Persistent Organic Pollutants 

(entered into force 2004yl. Initially, in all these conventions, toxicity identification was 

determined by a risk based assessment called a risk profile but more recently a numeric criterion 

has also been incorporatcd in addition to thc risk profile. Based on this vetting and discussion 

there is now international consensus that the UN Stockholm Convention and the Canadian TSMP 

criteria are scientifically-based and appropriate because these criteria are now incorporated into 

many national PBT regulatory programs. In Table I, I illustrate the cross-section of Persistence 

and Bioaccumulation criteria used in several national and international programs. This table 

illustrates that although there are some differences in criteria. most regulatory programs have the 

same or vcry similar criteria. The differences in criteria typically reflect differences in 

regulatory objectives. 

Using these criteria and assessment processes, very effective PBT screening identification and 

assessment processes have been on-going in Canada and Europe for approximatcly a decade. 

The Canadian Government in the Canadian Environmental Protection Act reauthorization in 

1999 initiated a process to identify and prioritize PBT substances that are in commerce in 

Canada together with chcmicals that have concerns lor human health. This initial screening or 

categorization of the approximately 23,000 substances on the Domestic Substances List was 

completed in September 2006. Environment and Health Canada are now conducting screening 

assessments on the 200 highest priority substances (of which 77 were identitied as potential 

PBT's) to determine whether the substance truly meets the criteria and if it is "toxic" or capable 

of becoming "toxic" as defined in CEPA 1999. This determination of toxic consists of 

conducting a risk assessment. which integrates the known or potential exposure of a substance 

with known or potential adverse effects on the environment and humans. A similar initiative was 

undertaken in Europe. Beginning in June 200 I, thc European Chemicals Bureau conducted a _ 

screening study to identify PBT substances among the 2682 high production volume chemicals'. 

Thcy identilied an initial list of 127 substances. which was finally reduced to 24 substances by 

incorporating data from manufacturers as part of a scientific review by regulators from across 

Europe. The next step in each of these programs after the initial PBT identification is to conduct 

1 http://www.ec.gc.ca/toxics/TSM P /EN/execsum.cfm 

2 http://www .cec.org/P age .asp ?Pagel D=9 24&Site N ode I D=237 

3 http://www.unece.org!env/lrtap/pops_hl.htm 

4 http://chm.pops.int/ 

5 The approach and results are described at 
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an evaluation of the sources. major em issions pathways to the environment in order to establish 

the most appropriate and effective measures to minimize risks to humans and the environment. 

Since the 1990s, the US EPA has also been actively involved in developing a strategy for 

identifying PBTs and in assessing these priority substances for more detailed review of their 

persistence, bioaccumulation and toxicity properties, risk assessment and management within 

several TSCA programs. On November 4. 1999. EPA issued its final policy statement (11+ I R 

(,\l i C)~) on a category for PBT new chemicals which represented the first formal statement of 

national policy regarding new chemical "persistent organic pollutants" ("POPs"). The policy 

statement provided guidance criteria ror persistence, bioaccumulation, and toxicity for new 

chemicals Crable I) and advised the industry about EPAs regulatory approach f<)r chemicals 

meeting the criteria. Using these criteria, the U.S. EPA initially developed a list of 53 chemicals. 

which was reduced to 28 organic chemicals and 3 metals based on comments and new 

information during public comment on the methodology. This list is used to help implement 

EPA's national RCRA waste minimization policy to reduce the generation ofPBT chemicals 

found in RCRA hazardous waste. [n2004, EPA established a goal ofa 10 percent reduction of 

these PBT priority chemicals by 2008 compared to a 2001 baseline. US EPA has complemented 

this waste minimization policy by adding many of these PBT chemicals to the Toxic Releases 

Inventory (TRI) reporting. For existing chemicals. PBT screening and the developed list of 

priority PBT substances has been used as one basis for choosing substances for development of 

EPA's chemical action plans. These National Action Plans for several of the chemicals included 

on the Priority Chemical list which include dioxinsifurans. hexachlorobenzene. mercury. 

benzo(a)pyrcne. and six additional polycyclic aromatic hydrocarbons (PAHs) are also used as 

part ofthe US '$ international commitments under NAFT A. the Canada-United States Binational 

Toxics Strategy, the United Nations Environment Programme's Persistent Organic Pollutants 

(POPs) effort. and the United Nations Economic Commission for Europe's Long Range 

Transport Air Pollutants (LRTAP) Persistent Organic Pollutants effort. 

Since 1999. PBT screening has been an integral part of EPA's New Chemical PM]\; review under 

TSCA to avoid approving new PBTs. To provide transparency to stakeholders. EPA developed 

an evaluation tool called the PBT Profiler. which predicts PBT potential of chemicals. This 

assessment tool estimates the environmental persistence (1'). bioconcentration potential (8), and 

aquatic toxicity (T) of discrete chemicals based on their molecular structure and compares the 

results to the PBT criteria The model compares results with the PHT criteria established for 

Premanufacture Notices (PMNs) submitted under section 5 ofTSCA. This tool has been 

recognized as an extremely valuable contribution to the international community regulators. 

industry and scientists - involved in PBT identification and assessments. 

TSCA MUST BE FLEXIBLE TO INCORPORATE STATE OF THE SCIENCE. These 

initiatives in United States. Canada. and Europe have illustrated that it is possible to identify 

PBT substances and to conduct risk-based assessments: however. the process can be a 

scientifically challenging and requires the active involvement of manufacturers and scientists. 

Some of these challenges are related to the low water solubility, difficulty in measurement. and 

attachment to surfaces of these types of chemicals. which cause them 10 be classified as "dilTicult 

to tesC substances. Thus. the scientific community has been working on developing guidance on 

how to evaluate chemicals with PB and T properties using readily available data. There has also 
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been an emphasis on developing improved test methods or modifying existing test methods so 

that the results are \alid for "difficult to tesC suhstances. For example. bioaccumulation tests 

have been modified to include new il1-rifro metabolism methods. Because of the wide range of 

challenges and the importance of PBT assessments, many scientific groups are actively involved 

in research to improve assessment approaches and ensure greater contidence in the final PBT 

conclusions. For example. the Society of Environmental Toxicology and Chemistry conducted a 

Pellston Workshop vvhose goal \Vas to improV'C the process ofidcntification and cvaluation of 

chemicals against the PBT criteria building on the most recent science6

• Organization for 

Economic Co-operation and Development (OECD) and HESl's Bioaccumulation Committee are 

actively engaged in developing and validating alternative methods for Bioaccumulation 

assessments. European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) has 

also developed guidance on how to conduct risk assessments for PBT substances? Given the 

rapid improvement in the test methods and guidance it is critically important for US EPA to 

contribute to and incorporate the most current science and scientific understanding in their 

assessments. especially as these relate to reducing animal testing. 

One recent example of the eftort to improve the process and guidance for pnT identification and 

assessment was Society of Environmental Toxicology and Chemistry's (SET AC) Pellston 

Workshop. This workshop which was held in January of2008 hrought together experts from 

academia. government. and industry to review and discuss significance recent advancements in 

our understanding of the behavior and potential impact ofPBTs in the environment as well as to 

develop recommendations for policy-makers on how to improve the science in the regulatory 

context. One concern raised by the workshop participants is that most of current national and 

international regulations dellne PBTs in terms of fairly strict pass or fail criteria. This is 

appropriate for early screening and prioritization but fails to recognize that the state of the 

science and our understanding of PBT which have vastly improved since these criteria were 

developed in the late 1970s and early 1980s. The incredible evolution in the state of the science 

since then has produced new insights into PBT substances and an array of new methods to 

identify PBT chemicals but the regulatory programs have not kept up with the rapid development 

in environmental chemistry and toxicology. As a result. scientists sometimes bring forward new 

data using the state-of-the-scicnce test methods and evaluations. but find the data rejected 

because the regulatory fi'amework does not allow for its consideration. With this background, 

any revision of existing frameworks for evaluating PBTs need to provide adequate flexibility to 

allow the introduction of additional. new. and emerging scientific evidence into the processes. 

One example is the application ofbioconcentration factors to judge whether a substance is 

Bioaccumulativc. ljnder most of the current regulatory schemes the only options arc older 

models known as the OECD 305 tests which use a large nlllnber of tlsh and are very time 

consuming and costly. Providing flexibility to incorporate improved predictive models. in vitro 

metabolism test data. shorter less animal intensive screening BCF test data. and field data in the 

'Integrated Environmental Assessment and Management Volume 5 Issue 4 Nine papers on p. 535-

711. 

7 ECETOC. TR 098 - Risk Assessment of PBT Chemicals. February 2006 

http://www.ecetoc.org/index.php?mact=MCSoap,cntnt01 . details.O&cntntO 1 by _ category=5&cntntO 1 templat 

e=display Jist_ v2&entntO 1 order _by=Reference%20Desc&cntntO 1 displaLtemplate=display _ details_ v2&c 

ntnto1 documenUd=277 &cntntO 1 returnid=89 
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evaluation would result in improved confidence in the PBT assessments while reducing cost, 

time and animals used in testing, The modernization ofTSCA should be Ilexible to incorporate 

new, validated methods that used advanced state-of-the-science methods, 

PBT'S MUST BE PRIORITIZED, ASSESSED FOR RISK AND, WHERE 

APPROPRIATE, MANAGED. For PBT screening identification, the chemical substances are 

evaluated as to whether they meet any of the three criteria. i.e .• are they persistent or 

bioaccumulativc or to:\ic. Depending on the objective of the particular regulatory framework 

within which the PBT identification is contained. the substances may be categorized into 

different groups by level of concern or priority depending on whether the substance meets a 

combination of these criteria. The highest priority for risk assessment and potential management 

are those substances that meet all three criteria - the combination of Persistence and 

Bioaccumulation and Toxicity. Canada's CEPA 1999 law took the focus beyond combined PBT 

to specify that chemicals which were persistent and toxic only (PiT) or bioaccumulative and 

toxic only (BiT) should also be prioritized, albeit with the very highest priority placed first on 

chemicals that meet all three criteria tor P. Band T. The EU PBT strategy focused priority on 

those chemicals that are P, Band T and those that are very persistent and very bioaccumulativc 

only (i.e .. meet UN Stockholm Criteria P and B criteria) which arc called vPvB. These options 

in how to prioritize substance tor TI.lrtilcr scrutiny and risk-based assessment have some scientific 

basis. and can be incorporated into a priority setting approach based on PBT categorization. It is 

important to recognize that even if the same criteria are used to identify a PBT. the different 

regulations may designate them by different abbreviations (Table 1). 

In all of these PBT identification programs. the initial prioritization of the substance is based on 

whether it meets the combination of PB and T criteria. The next step is to conduct a scientific 

risk-based assessment of potential for harm. This risk assessment process is separated Irom any 

final risk management decision although it can be used to intorm potential risk management 

options. Furthermore. there is a range ofmanagcment options available depending on uses of the 

substance. For example in the Stockholm protocol, management options range from I) 

prohibition and legal or administrative action to eliminate the production and use of the chemical 

(Annex A) to 2) allowing production and specific exemptions for use by specific parties (Annex 

B). Environment Canada's PBT assessments also allow for range ofmanagcmcnt options from 

no-further action at this time to implementation ofvirtual elimination. 

All of these programs. both nationally and internationally have illustrated that the use ofPBT 

identification for existing chemicals would result in a relatively limited number of substances to 

assess and for which. if necessary, develop management strategies. It is not possible to predict 

the final number of PBT substances currently in commerce nationally and/or internationally that 

will require risk assessment and potential management: however. it would appear to be less than 

100. For example. within the Stockholm POPs Protocol the initial number of high priority 

substances was 12 many of which were no longer manufactured. Currently an additional 9 

substances have been recommended for listing in Annexes A. Band/or C with specific control 

measures. An additional three substance are under review. The EU review of their 2683 high 

volume chemicals resulted in identitication of24 PBT substances. The Canadian DSL 

categorization of 23.000 substances identified 77 PBT substances. The US EPA list of organic 

priority PBT substances is 30. There is a significant overlap of the substances across the lists. 

Some of the ditferences in numbers relates to the targeted objectives of the different national 
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programs, the actual value of the criteria and the way that these criteria are combined in the final 

identification (sec Table I). 

RATIFICATION OF INTERNATIONAL CONVENTIONS SO THAT EPA CAN BRING 

SCIENTIFIC LEADERSHIP TO INTERNATIONAL FORA. My concern is that although 

the US and EPA scientists hme publically committed to working with the international 

community to address chemicals of international concern and the EPA scientists were very active 

in the discussions on PBT screening criteria and assessment process on many of these 

international protocols including UNECE's POPs protocol and the Stockholm POPs convention, 

the US has not become a signatory to either of these critically important chcmicalmanagement 

conventions. In 13Ct. the October 5. 1998 notice that signaled the development of EPA's PBT 

strategy stated that part of the intent of this notice was to alert the parties involved in negotiation 

of the United Nations Environment Programme (U:--JEP) POPs Convention that the US was 

taking leadership on this issue. It was envisioned that this strategy could serve as a model for 

other countries in taking steps to discourage the introduction of chemicals with PBT properties as 

new chemicals and pesticides. In fact. the development of the PBT profiler has been a key 

contribution to this strategy and a tool that is uscd internationally as mentioned previollsly. 

However, the leadership position of the US in international chemical management has been 

weakened by not becoming a full signatory to these critically important conventions. I strongly 

urge the US to become a signatory to these Conventions so that U.S. government scientists can 

once again bring their knowledge and expertise forward in leadership internationally as full 

parties to these conventions. Within this role, the US and its scientists can also play an important 

role in leading first world nations to increase their participation in the global identification. riskbased assessment and management of PBTs which will improve the safety of US citizens from 

these international pollutants. Because, as mentioned previously. the process of identification, 

assessment and where necessary, risk management of PBTs is being continuously improved. 

EPA scientists should be in a position to provide leadership within these technical areas in the 

US as well as globally. Full US participation in these agreements is critical in maintaining. riskbased and science-based processes in PBT identification. assessment and management efTorts 

globally. Thus. as you consider modernization ofTSCA, in addition to becoming full signatories 

and parties to these conventions, it wi II be very important to provide adequate funding of EPA 

scientists to be integral members of national and international groups working on the continual 

improvement of methods and assessment approaches. 

STRONG NATIONAL PBT PROGRAM. It is also important that the US EPA develop a 

stronger Federal PBT program to build confidence so that States do not have to take separate and 

potentially conflicting actions to identify and manage these types of substances. Most states 

don't have the depth of scientific expertise nor the number of staff to effectively conduct these 

scientifically challenging assessments. Thus, a role that EPA can play is to develop and 

promulgate methods for identillcation and assessment and provide assistance to states that are 

interested in investigating PI3Ts. To ensure acceptance and a technically strong. comprehensive 

process for identification and assessment ofPBT's. these methods should be developed within a 

scientific multi-stakeholder process or through the use ofa Scientific Advisory Panel. This will 

also require a cOlllmitment tI'om Congress for full funding. staffing. and support of such a strong 

Federal PBT program. 
52 


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Ultimately a reform ofTSCA that contains a strong commitment and adequate funding to a 

Federal program Jor PBT identification. assessment and management and US leadership 

internationally in PST conventions \\·ill encourage technical innovation ofnelV chcmicals and 

products that will improve the lives of US citizens and the international community. As a result. 

this modernized TSCt\ will benefit the US citizens as it will contribute to improving global 

public health and the cnvironment for c:l.isting chemicals and provide assurance that new 

chemicals that havc PST properties will not enter commercc. 

Mr. Chairman and distinguished members of the suhcommittee, thank you again for the 

invitation to testify here today. In the meantime. I look torward to answering any questions you 

may have. 

Table 1; Persistence and Bioaccumu]ation Criteria and their use in Variolls Regulations and 

Conventions. 

BioacclImlilation BCF/BAF* > 1000 BCFiBAF* > 2000 BCFiBAF* " 5000 

Criteria 

--------

Persistence Criteria 

(halt~lives) 

--- .... ----.. ---. Water 180 days 

I 

• US EPA New Chemicals 

Soil ~ 180 days Program (Ban)' 

• Canada TSMP 3 

Sediment 360 days NAFTASMOC' 

Water = 60 days • EUTGDPBT • Stockholm POPs Protocol ·i 

Soil ~ 180 days • UNECE POPs Protocol' 

Sediment = 180 days • EU vPvB 7 

Water - 60 days • US EPA New 

Soil 60 days 

Chemicals Program 

(SNUR)' 

Sediment -" 60 dav~ 

*BIOconccntralion Factor (BCF)/BIOaccumulation Factor (BAf) 

L US EPA New Chemicals Program. 64 FR 60194 Catcgol) for Persiste!lt. Bioaccu!11ulathe and To.\ic New 

Chemicals ).io\",4 1999. TSC/\ 5e Action. Ordt.:r Pending Testing/Significant Ne\\ l'sc Rule (SNL:R). Criteria 

also used in olher TSC/\ rcgubtor) programs. 

2. tJS EPA New Chemicals Progral11. 6-1- fR 60194 Catcgor) for Persistent. Bioaccumulati\c and To:-..ic ~C\\ 

Chemicals Nov.4 1999. TSCA 5c Action. Ban Pending Testing, Criteria also used in other '! seA regulator) 

programs. 

3. Canadian TS\,tP Crit('ria. 

CatcgoriLation orthc DSIJ. 

4, Stockholm Persistent Organic Pollutants Protocol. 

l'hcsc criteria "cre used in the 

5, 1998, larhus Proloco! on Persistent OIXa17ic Pol/lilallts ! ;1" 

6.N ~fTA Commission for Em'ironncmental Cooperation's Sound Management ofChemiculs InitiJthe. 

~ _! ,'1 ~: ( \-::::< ~ , 

7. European Conm1issioll Joint Research Centrc Institute 1'01' Health and Consumer Protection. it)r 

http://ecb.jrc.ec.curopa.eu/csis/index.php?PC.i\'l-pbt 

--
53 

Mr. RUSH. The chair now recognizes Mr. Sturdevant for 5 minutes. 

STATEMENT OF TED STURDEVANT 

Mr. STURDEVANT. Thank you, Mr. Chair, members of the subcommittee for holding this hearing and for having me. 

My name is Ted Sturdevant. I am the director of the Washington 

State Department of Ecology. 

Citizens in Washington State, like elsewhere, I imagine, expect 

from government basic health protections from things like toxic exposures. In recent years, we in Washington were seeing rising levels of concern around toxic chemicals and so a few years ago we 

made an agency priority the reduction of toxic threats in our State, 

and we started with starting the nation’s first PBT program. That 

seemed like a very logical place to start for reasons that you have 

heard. It is very clear that we should be very careful with PBTs 

and it is also very clear that we are not very careful with PBTs. 

I had a real ah-ha moment when we were writing our PBT regulation. I was at home one morning, shaving, and I looked at the 

ingredients in the shaving cream and Nonylphenol was on there 

and the only reason that I knew what the heck that was is that 

we were considering inclusion of that chemical in our PBT list. It 

was right on the bubble and, you know, nothing on the can indicated it was anything I should be worried about and it just and, 

you know, I was rubbing this stuff on my face every day, and it 

just left me with this sense that no one was really watching and 

certainly not watching as closely as we should be. 

I think that only prevention works with PBTs. Once you let the 

PBT genie out of the bottle, you can’t get it back in. PCBs are a 

great example of that. They were banned 34 years ago but today 

PCBs are flowing into Puget Sound all the time. We are spending 

millions of dollars on cleanup and we are still seeing fish and wildlife impacts from PCBs. 

A good and more recent example of both the challenge and I 

think the solution is found in the PBDE flame retardants you have 

heard about. They have been around since the ’70s. In 2003, we 

were seeing rising levels of PBDEs in Washington’s environment 

and citizens. We didn’t really know much about them. They were 

appearing in women’s breast milk, in house dust that babies crawl 

around in, in polar bears in the artic. So we decided to take a look 

at them as part of our PBT program. We spent 3 years working on 

a chemical action plan for those flame retardants and the more we 

looked, the more concerned we grew. Levels kept rising. Studies 

kept showing more health concerns. 

In the meanwhile, industry was applying pressure saying they 

are safe, that we need to protect fire safety standards. We need to 

keep studying them and basically that everything was fine but we 

reached a very different conclusion. We decided that if there were 

better ways, if there were safer ways to flame-retard products in 

our homes, like TVs, computers, mattresses, furniture, then we 

should stop using PBDEs and use those safer alternatives, and we 

found ourselves in the middle of quite a fight. Some very sophisticated folks showed up in Olympia and fought us pretty hard on 

that and it took awhile but we did finally get there and we passed 


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54 

the nation’s first ban on the deca-form of PBDEs but that was only 

one State. The other States, several other States had to then go 

through the same fight, take different approaches and the good 

news is that enough States did that, that there was a recent announcement of a voluntary phase-out of deca production in the 

United States. 

The bad news is that is not a very good system. It takes too long. 

It costs too much. It creates this patchwork of regulatory approaches across the country and it lets far too much unnecessary 

toxic contamination happen in the meantime. 

I don’t think at the root of this that the problem or the solution 

is terribly complicated. We need a Federal system that works based 

on a few commonsense principles. First, before allowing a substance to be put out there into widespread commerce, we should 

make every reasonable effort to make sure that it is safe. I think 

that it is fair that that burden rest on industry rather than on EPA 

and the taxpayers. Second, if we know that there are chemicals out 

there that are causing environmental or human health problems, 

government should be able to step in, protect citizens and ban 

those chemicals. Third, if we know with reasonable certainty that 

a substance poses problems and there are safer alternatives, we 

should stop using that and switch to the safer alternative. 

With PBTs I think we already know enough that we should be 

very careful and make every effort to phase-out those uses that we 

can do without and prevent new uses. These seem to me to be 

sound, fair principles for a reasonable chemicals policy but it is not 

the one we have today. I would urge you to fashion such a policy. 

This isn’t about being anti-chemical. It is about being pro-saferchemical whenever you can and should. 

As you look at TSCA, I would ask you to keep in mind the role 

that the States have played in advancing protections from PBTs 

and other toxic chemicals. Even with TSCA reform, if another 30 

years go by before we revisit it, we are going to need the States 

to fill in the gaps and be the laboratories of reform, and I would 

ask you to preserve our ability to do that. And because we at the 

State level need a strong Federal system, Washington and 12 other 

States in December issued our principles for reform of TSCA and 

those were provided to you with my written testimony. 

Finally, one other priority that we have in the State of Washington is restoring our Puget Sound to health by 2020. That problem with the Sound is not just about toxic pollution but toxic 

chemicals are entering the Sound everyday. Now, fixing TSCA 

won’t fix Puget Sound but if we don’t fix TSCA, and prevent a lot 

of that toxic contamination that could be prevented, we are not 

going to fix Puget Sound, and I don’t think we are going to fix a 

lot of our other waterways, either, and we will continue to experience toxic exposures that just don’t need to happen. 

So with that, I would like to express my very sincere gratitude 

for your looking at this issue and I respectfully urge you to craft 

a strong chemicals management policy that this country very much 

needs and deserves. Thank you. 

[The prepared statement of Mr. Sturdevant follows:] 


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Testimony of Ted Sturdevant 

Executive Director 

Washington State Department of Ecology 

Before the 

Subcommittee on Commerce, Trade and Consumer Protection 

Committee on Energy & Commerce 

U.S. House of Representatives 

March 4, 2010 

I appreciate the opportunity to testify on this important issue. My name is Ted Sturdevant, and 

I am the Director of the Washington State Department of Ecology. In Washington State, we 

have made the reduction of toxic threats one of our top strategic priorities. One of the 

foundations of that effort has been our focus on phasing out persistent, bioaccumulative toxics, 

or PBTs. 

I am not a scientist, and I'm sure you will hear from others more qualified to speak to the 

unique dangers posed by PBTs. These chemicals are often called "the worst of the worst" 

because they persist in the environment, they build up in our bodies and the food chain, and 

they are toxic. Over 10 years ago, we recognized that if we were serious about protecting 

human health and the environment in Washington from toxic contamination, PBTs were the 

right place to start. Washington was the first state in the nation to target PBTs, developing a 

PBT strategy in 2000 and adopting regulations in 2006 to phase out their uses and releases. We 

have since developed and implemented chemical action plans on mercury, PBDE flame 

retardants and lead, and we are now beginning work on PAHs, or polycyclic aromatic 

hydrocarbons. 
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This approach has resulted in the collection and proper disposal of over 14,000 pounds of 

mercury that otherwise might have been released to the environment or led to human 

exposure, and helped shape the national program to remove mercury switches from 

automobiles. 

It also led to the nation's first ban on decaBDE, a commonly used flame retardant, after years of 

research and a great deal of political opposition. Since then, several other states have banned 

decaBDE, and recently the EPA announced the phase-out of decaBDE production in the U.S. 

And our action plan on lead resulted in a ban on lead wheel weights, and ongoing work to 

eliminate the threat of exposure among children to lead paint in older homes. 

That may sound like I'm boasting of our success, but the truth is that our approach to 

protecting people and our environment from toxic chemicals is a failure. It's a failure at the 

state level, and it's a failure at the national level. We are failing to prevent avoidable harm to 

our children, we are failing to protect the food chain that sustains us, we are failing to save 

countless millions of taxpayer dollars that are wasted on health care costs and environmental 

cleanup, and we are failing to exercise common sense. 

After working on toxics issues for the past several years, I have found that behind the science, 

behind the congeners and the acronyms and the chemistry, the core of this debate is actually 

quite simple, and it all comes down to common sense, and the old adage that an ounce of 

prevention is worth a pound of cure. I think the basic principles for a rational chemicals 

management policy are these: 

2 
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First: before you allow a substance to be put into widespread use and commerce, it makes 

sense to take all reasonable measures to first make sure it is safe. 

Second: if science tells us that there are toxic chemicals that pose an urgent and unacceptable 

threat, government should be able to protect the public and ban those chemicals. 

Third: if we know with reasonable certainty that a particular substance is dangerous to people 

or the food chain and doesn't break down; and if we know that allowing continued use of that 

substance will spread it far and wide; and if there is an alternative substance that could perform 

the same task much more safely; then the right policy is simple: stop using the dangerous 

substance, and use the safer alternative. In the case of PBTs, we already know enough that we 

should make every effort to phase out current uses and prevent new uses. 

These concepts seem to me to be sound, fair principles for a reasonable chemicals policy. But 

none of these principles - precaution, targeted bans when needed, or encouraging the use of 

safer alternatives - describes current policy. Instead, the burden of proof is on EPA to prove a 

chemical unsafe, without the proper tools or data to do that job. And even in instances where 

safer alternatives exist for a chemical for which there is clear cause for concern, there is no 

effective mechanism to require or encourage switching to the safer alternative. 

PCBs provide a good example of how the system doesn't work. The production of PCBs began in 

the 1920's, and by the 1930's there were already studies suggesting that PCBs were harmful to 

humans. Production and use continued to increase, as did the data warning of concerns. The 

EPA finally banned PCBs in 1979, after more than SO years of widespread use. Since then, 

3 
58 


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despite the ban and millions of private and taxpayer dollars spent on PCB cleanup in 

Washington State, significant amounts of PCBs continue to flow into Puget Sound today. 

This is a critical point; when we put persistent toxics out into the world, they persist. And if 

they turn out to be a problem, then the problem becomes enormous, and largely unsolvable. 

Once out, we cannot ever truly put the PBT genie back in the bottle. This has been an 

expensive lesson that we all should learn from - when we uncork that bottle, let's be as sure as 

we can that it makes sense to do so. 

Without a system that starts with precaution, allows targeted bans and effectively moves us 

from less safe to more safe products, we at the state level are forced to fight for and fund 

solutions on a patchwork basis, as more and more of us recognize that federal chemical policy 

does not provide the tools we need to carry out our missions to protect our citizens and 

environments. State by state, chemical by chemical approaches are not efficient or effective 

ways to address PBTs, which do not respect jurisdictional boundaries. 

While I would much prefer a strong federal system, and at long last have great hopes for TSCA 

reform this year thanks to your interest and leadership, please keep in mind the critical role the 

states have played in advancing protections from PBTs and other toxic chemicals. Even with 

effective reform this year, if another 30 years go by before revisiting TSCA, we will need the 

states to fill in the gaps and serve as the laboratories of reform, and I ask you to preserve our 

ability to do so. 

Because the need is so clear for federal reform, Washington and twelve other states issued in 

December our Principles for Reform of the Toxic Substances Control Act, outlining our hopes for 

4 
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an effective federal chemicals management program, which I have provided with my written 

testimony. 

I'd also like to speak to the politics of chemical policy. Not many years ago, toxies issues were 

widely perceived as being outside the mainstream. Battle lines were commonly drawn along 

ideological or partisan lines. I believe this has changed significantly in the past few years. As 

our scientific understanding of impacts from various chemicals has increased, as work on green 

chemistry and safer alternatives has progressed, and as the public has become aware of holes 

in the system designed to protect us from toxic exposures, the demand for action has risen 

dramatically, and not along party lines. 

Rather than pitting jobs against the environment, intelligent reform protects both. When we 

identified a safer alternative to decaBDE, that alternative was being manufactured by some of 

the same companies that produced decaBDE. The choice is not about whether we are able to 

produce or use critical products like flame retardants, it is instead about using the least harmful 

of those products when it is warranted. 

Our ban on decaBDE was a strongly bipartisan vote, and in the last few weeks, the Washington 

Legislature passed bills to ban certain products containing Bisphenol A by a 36-9 vote in the 

state Senate, and 95-1 in the state House. We did this with strong bipartisan votes because the 

bill made common sense - there is legitimate cause for concern over that chemical, and clearly 

safer alternatives exist for those products named. 

5 
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There is nothing partisan about the principle of prevention, nor can I see an ideological divide 

over the principle that when safer alternatives are available that would allow us to avoid 

human and environmental harm, and save taxpayers money, we should use them. 

As you contemplate reform of the Toxic Substances Control Act, I ask you to build a preventive 

framework that requires reasonable measures to show that chemicals are safe before they are 

allowed into widespread commerce. 

And for those chemicals that are already out there among us, I ask you to create a system that 

prioritizes chemicals of concern, and provides effective tools to address them. For the worst of 

the worst, EPA needs to be able to ban them, with PBTs at the top of that list. For others, we 

need a clear means of determining whether safer alternatives exist, and a mechanism that 

moves us toward those safer choices. 

I appreciate the opportunity to testify today, and I deeply appreciate your interest in 

strengthening our nation's approach to protecting our citizens and environment from avoidable 

toxic contamination. 

6 
61 


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STATES' PRINCIPLES ON REFORM OF THE 

TOXIC SUBSTANCES CONTROL ACT 

DECEMBER 2, 2009 

Require Chemical Data Reporting. Chemical and product manufacturers should be required to 

develop and provide chemical health and safety information. as wcll as exposure and use data. 

including the presence of toxic chemicals in products and the associated chemical hazards and 

risks. to regulators. businesses. and the public. 

Demonstrate Chemicals and Products are Safe. Manufacturers should provide the necessary 

information to regulators to conclude that new and existing chemicals and products in commerce 

are safe and do not endanger the public or the environment. The public has a right to expect that 

the products they use are safe. 

Prioritize Chemicals of Concern. Government should identify and prioritize chemicals of 

concern in order to regulate the most problematic chemicals in commerce, and have the authority 

to take timely action to protect people and the environment. Sutlicient resources should be made 

available to SUppOlt these actions. 

Protect the Most Vulnerable. Chemical regulation should be designed to protect the most 

vulnerable, including pregnant women and children. 

Promote Safer Chemicals and Products. Based on green chcmistry principles. manufacturers 

should be required to assess and identify safer alternatives to problematic chemicals of concern. 

Government should establish protocols for evaluating potential alternatives to chemicals of 

concern. 

Address Emerging Contaminants. Emerging chemicals of concern. including nanoscale 

materials. need to be assessed for public and environmental safety before they go into 

widespread commerce and usc. 

Strengthen Federal Law & Preserve States' Rights. States acknowledge the need for a strong 

federal chemical regulation system. while expressly preserving the authority of state and 

localities to implement measures to managc chemicals of concern. 

Fund State Programs. Effective state-federal governance should enhance the role of states in 

TSCA implementation. promote data and inlonnation sharing. and provide sustained funding for 

state programs. The states are in a unique position to provide innovative. cosl-effective solutions 

for chemicals of concern prioritization, interslate dala sharing. and safer chemical alternatives 

assessments. 

C;:JhfMntil! Conn<"cliCllt J l11mo1"! !\lame I Ma01and MaS5ac1msetls! :vhchig:m' N~'\\ Hamr~!nre! 1\<.:\\ .krs('~ ! New York IOrt'gon Vermont! Was1111lgton 
62 


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States' Principles on Reform of the Toxic Substances Control Act 

December 2, 2009 State 

S, Adams, Secretary 

California Environmental 

Protection Agency 

p, Scoll, Director 

Environmental Protection Agency 

David p, Littell, Commissioner 

Maine Department of 

Environmental Protection 

Shari T, Wilson, Secretary 

Maryland Department of the Environment 

Laurie Burt, Commissioner 

Massachusetts Department of 

Environmental Protection 

Steven E. Chester, Director 

Department of Environmental 

Thomas S, Burack, Commissioner 

New Hampshire of 

Environmental 

Mark N. Mauriello, Acting Commissioner 

New Jersey Department of Environmental 

Protection 

Pele Grannis, Commissioner 

New York State Department of 

Environmental Conservation 

Dick Pedersen , Director 

Department of 

m!lrl1nm""nt~ Quality 

Commissioner 

Environmental Conservation 

Ted Sturdevant, Director 

Washington State Department of 

California I Connetticut I Illinois : Maine! Maryland! Massaehuse~,s i Michigan i New Hampshire 1 New Jersey I New York I Oregon! Vermont I Washington 
63 

Mr. RUSH. Thank you very much. 

Now, the chair recognizes Dr. Adams for 5 minutes. 

STATEMENT OF WILLIAM ADAMS 

Mr. ADAMS. Thank you, Mr. Chairman. It is my pleasure this 

morning to testify and talk about Toxic Substance Control Act and 

PBT particularly as it applies to metals. 

I am the chairman of the North American Metals Council. I am 

also a scientist and I have worked in the area of PBTs since the 

late ’70s, and specifically, in the 1990s, and more recently on the 

REACH legislation in Europe. And over the course of time, I have 

published some hundred papers and I have published a book on 

PBT, so let me begin. 

I would like to give you some details about why PBT, some of the 

criteria of PBT are not applicable to metals. I would also like to 

give you some information as to how I think the hazard of metals 

and inorganic substances should be determined. 

Regarding persistence, persistence is problematic for metals because all metals and elements on the Periodic Table are conserved, 

and hence, they are persistent. The form and availability of the 

metal can change depending on the environmental conditions. They 

are also different for each metal element on the Periodic Table and 

this should be considered. Thus, setting a criterion say of example 

of removal of 70 percent in 28 days in the water automatically includes all the metals, and this includes the ones that are essential 

such as copper, zinc and iron, which are essential for life. As a result, applying criteria that were designed for organic substances to 

the metals then creates problems that are not necessarily needed. 

Regarding bioaccumulation, unlike organic substances, bioaccumulation potential of metals cannot be estimated using octanol-water partition coefficients. This is a common approach to estimate the amount of substance will accumulate in the fat of an organism. Bioconcentration and bioaccumulation factors are inversely 

related to exposure for metals. This is not the case for organics. 

The consequence of this is that in the most cleanest environments 

we have, let’s take Lake Superior. What we find in that situation 

is that we have the biggest bioaccumulation factors. PBT criteria 

used, for example, use a bioaccumulation factor of 1,000 to decide 

whether a substance is bioaccumulative. All the metals pass that 

criteria for Lake Superior so, in fact, the whole approach is 

counterintuitive. The cleanest environments give you the biggest 

bioconcentration factors. In short, that B does not work for inorganic substances. 

Regarding toxicity, metals are generally not soluble. Toxicity results are almost always based on soluble metal salt that has been 

used in some toxicity tests for some organism. However, those are 

not the products that are put in the marketplace. By and large, the 

massive metals, the powders, the oxides, the sulfites are insoluble 

substances. I would like to point out in our recent discussions with 

the European Commission, we had this same discussion and after 

a long period of time and many testimonies the REACH regulations 

now acknowledge that PBT criteria do not apply to metals, and you 

can find this in the text of the Annex XIII of the REACH regulation. 


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64 

Now, I would like to take a moment or two then to propose an 

alternative. If we argue that P and B are not applicable to metals 

then let’s look at what I think might work. 

In 2003, I chaired a SETAC, environmental toxicology and chemistry, sorry, Society of Environmental Toxicology and Chemistry 

workshop. We invited some 40 scientists from around the world to 

participate in this and the specific issue at hand was, how do we 

assess the hazard of metals. At this workshop PBT issues were discussed at length and reported out in a book which I edited. 

Consensus was reached at the workshop that the individual criteria, P, B and T, are limited in their ability to assess hazard or 

to prioritize metal substances. The criteria are not linked or integrated, and they attempt to identify or predict hazards using bioaccumulation and persistence as modifiers of toxicity but without 

fully incorporating other important fate characteristics, which for 

metals can include speciation, complexation, precipitation, dissolution, transformation, and sedimentation, and the approach does not 

consider exposure or release rate so we are essentially assessing 

hazard but no effort to assess risk. 

The science community recommended that a more comprehensive 

approach be taken for both metals and organics in which a generic 

hazard ranking could be determined using a model which simulates 

natural receiving water such as a lake. The model is termed a Unit 

World Model. The aim is to incorporate partitioning, transport, reactivity, bioavailability, and exposure route to give a single, transparent metric of hazard. It is essentially a critical load approach 

in which an estimate is made at the rate of which a chemical must 

be introduced into a common defined environment to achieve a concentration that becomes toxic, and the output of this model then is 

a calculation of the rate and the amount that has to be released 

to cause a problem. This allows then a ranking of both metals and 

organic substances so that you now not only just have criteria that 

says yes, it is PBT, but you have a ranking of the substances. Following the workshop, efforts have been ongoing to develop and validate this model and we worked on this now for 6 years. This model 

is now available and it can be downloaded and you can find it at 

www.unitworldmodel.net. 

In conclusion, attempts to universally and indiscriminately apply 

PBT criteria to all chemical substances and, for example, including 

metals, would be of concern, and would not necessarily reflect good 

science. Similarly, PBT information, by itself, cannot determine 

risk and such criteria should not be used in isolation as a basis for 

requiring regulatory action. It is important, and I summarize, to 

understand that persistence and bioaccumulation factors are not 

particularly useful for assessing metals. I believe the state of the 

science has moved beyond PBT and we have an opportunity to use 

more integrated, and a more reliable approach that not only considers the hazard but also considers release rates and processes 

that occur in nature, and this approach is now available. 

I thank you for this opportunity and I would be pleased to take 

any questions. 

[The prepared statement of Mr. Adams follows:] 


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WRITTEN STATEMENT OF 

WILLIAM ADAMS, Ph.D. 

CHAIRMAN OF THE 

NORTH AMERICAN METALS COUNCIL (NAMe) 

AS SUBMITTED TO THE 

SUBCOMMITTEE ON COMMERCE, TRADE & CONSUMER PROTECTION 

COMMITTEE ON ENERGY & COMMERCE 

U.S. HOUSE OF REPRESENTATIVES 

ON 

"PERSISTENCE, BIOACCUMULATION AND TOXICITY (PBT): 

STRENGTHS AND WEAKNESSES" 

March 4, 2010 
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Introdnction 

As Chainnan of the North American Metals Council (NAMC), I appreciate the opportunity to 

submit this testimony for the Subcommittee's consideration. NAMC is an unincorporated notfor-profit group of metals-producing and metals-using associations and companies that focuses 

on science and policy issues that affect metals in a generic way. On behalf ofNAMC members, 

I am pleased to provide these comments on the use of PBT -- or persistence, bioaccumulation, 

and toxicity -- for assessing the hazard of chemical substances, including metals and metal 

compounds. 

My background is as a scientist with a Ph.D. in Environmental Science with 14 years work 

experience in the organic chemical industry and 15 years experience in the metals industry. I 

have published several papers specifically addressing PBT issues and edited a book on the 

subject. Over the years, I have developed approximately 100 technical papers in the 

environmental science field. Additionally, I served on the U.S. Environmental Protection Agency 

(USEPA or EPA) Science Advisory Board for 10 years. I currently work for Rio Tinto, a global 

mining company. 

As Chainnan ofNAMC, I am particularly proud ofNAMC's cooperative role with EPA in the 

development of the Framework/or Metals Risk Assessment (Framework).! The Framework was 

published in 2007 and outlines key principles on how metals should be considered in health and 

ecological risk ass~ssments. As recognized by EPA in the Framework, inorganic metals and 

metal compounds present unique issues for risk assessors and generally should not be assessed 

using models developed for organic substances. It is with this perspective that ! offer the 

following comments. 

What Are PST Criteria and How Are They Used? 

PBT criteria are measures of chemical substance properties that have been used since the early 

19705 to assess the hazard and key environmental fate attributes of chemicals as a means to 

identifY substances that have the potential to harm the environment. In the U.S., the 

development of hazard and risk assessment methodologies for chemical substances began in the 

late 19605 and early 19705 to fonnalize an approach for selecting product substitutions (for 

example in the soap and detergent industry and eventually in the pesticide and industrial 

chemical industry). Hazard (or "toxicity") is defined as a measure of the inherent (intrinsic) 

capacity of a substance to cause an adverse response in a living organism. Risk is 

EPA. 2007. Framework fbI' metals risk assessment. EPA 120fR-07/001, Office of the 

Science Advisor Risk Assessment Forum, USEPA, Washington, DC 20460. Available at 

http://www.epa.gov/raf/metalstrameworklpdfs!meta!s-risk-assessment-final.pdf. 

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defined/described as the integration of hazard and exposure infonnation and is thus not an 

intrinsic attribute of a substance (e.g., the extent of risk will vary depending on the extent of 

exposure). 

In the context ofPBT approaches, "T" or toxicity has been used primarily, but not exclusively, to 

assess the hazard of substances to aquatic organisms. "B" typically refers to bioaccumulation in 

fish or other aquatic species; there are no universal metrics of B for humans. "P" refers to 

persistence and is generally measured as a half-life for degradation in the environment. This can 

include biological (biodegradation) as well as chemical (e.g., hydrolysis, photolysis) processes. 

In the 19905, there was increasing recognition that organic chemicals such as polychlorinated 

biphenyls (PCBs) and dichlorodiphenyltrichloroethane (DDT) that present properties of P, B, 

and T are of particular concern for their potential effect on the environment. 

There have been several primary uses ofPBT infonnation: 

III prioritization of substances for further testing; 

III environmental hazard classification of substances and use in safety data 

sheets; 

III ranking and/or selection of priority substances; 

III selection of contaminated sites for further evaluation; and 

III selection of substances for water, soil, and sediment quality guidelines or 

criteria. 

There is considerable literature on the environmental assessment of organic substances focusing 

on Persistence (P), BioacculTIulation (B), and Toxicity (T).v.4.s These factors arc used in 

Adams, W.J., B. Conard, G. Ethier, K.V. Brix, P.R. Paquin, and D.M. DiToro. 

2000. The challenges of hazard identification and classification of insoluble 

metals and metal substances for the aquatic environment. Hum. Ecol. Risk Assess. 

6(1): 1019-1038. 

Kleka. G, Boethling B, Franklin J, Grady L, Graham D, Howard PH, Kannan K, Larson 

RJ, Mackay D, Muir D, van de Meent D. 2000. Evaluation of Persistence and LongRange Transport of Organic Chemicals in the Environment. SETAe Press, Pensacola, 

FL, USA. 

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Canada, 6 the U.S.'? and elsewhere by national and international (e.g .• the 

StcoeklllOim Convention on Persistent Organic Pollutants8). In the U.S., PBT have been 

used to identify substances of concern for waste minimization, emissions reporting, and for the 

identification of substances for stricter regulations (air, water, solid waste). In Canada, a PBTapproach is one avenue used for categorizing substances on the Domestic Substances List 

to determine if a screening assessment is required. Most recently, the use of PBT has 

been applied in Europe as part of the Registration, Evaluation, Authorization and Restriction of 

Chemicals (REACH) legislation, wherein PST criteria are used as part of an overall approach for 

identifying substances that may require Authorization for continued use. 

For reasons that I will explain in more detail below, it is very important to recognize that there is 

acknowledgement in the REACH regulations that these PST criteria do not apply to metals.9 

The text in Annex XIII, which outlines the criteria for identification of PST substances, 

specifically notes that "this annex shall not apply to inorganic substances," which includes 

metals, although it does apply to organo-metals. 

Scheringer M. 2002. Persistence and Spatial Range of Environmental Chemicals: New 

Ethical and Scientific Concepts for Risk Assessment. Wiley & Sons Inc. Hoboken, NJ, 

USA. 

Lipnick RL, Hennens JLM, Jones KC, Muir DCG (eds). 2000. American Chemical 

Society Symposium Series No.772 Persistent, Bioaccumu!ative, and Toxic Chemicals: 

Volume I. American Chemical Society, Washington, DC, USA. 

Government of Canada. 1999. Canadian Environmental Protection Act (CEPA). 

Government of Canada, Ottawa, ON, Canada. 

EPA. New Chemicals PBT Policy at 

TOX/19991N0vember/Day-04/t28888.htm. 

Stockholm Convention on Persistent Organic Pollutants at 

Commission of the European Communities. 2001. Amended Proposal for a Decision of 

the European Parliament and of the Council Establishing the List of Priority Substances 

in the Field of Water Policy, Paragraph 20 (Jan. 16, 2001); Official Journal of the 

European Union, ANNEX xm - Criteria For The Identification Of Persistent, 

Bioaccumulative And Toxic Substances, And Very Persistent And Very Bioaccumulative 

Substances. 

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Recognized Limitations of PDT Applications 

The scientific underpinnings ofthe use of PBT lie in the fact that these measures are believed to 

represent inherent or intrinsic properties of the chemical. As such, these properties are 

independent of environmental changes in temperature, pressure, fish species, etc., or other 

factors, especially exposure concentration. This turns out to be only partially true, as it is known 

that biodegradation studies used to measure P are subject to changes in temperature as this 

affects the rates of biodegradation by microorganisms. B is also affected by temperature and 

length of the exposure, and the potential for metabolic breakdown (metabolism) which can differ 

between species. 

To overcome these difficulties, standard test methods have been established such that the 

measures reflect pseudo-intrinsic values. For both P and B, the test results obtained for most 

organic substances using these methods are independent of test concentration making the 

measures relevant to real world systems where concentrations often vary. Toxicity, however, is 

directly related to exposure concentration and duration (e.g., acute versus chronic exposures) and 

therefore test conditions are standardized to allow for repeatable measures of toxicity to standard 

species . 

. In the U.S., PBT was proposed for use by the USEPA in 1997 for selection of substances for 

waste minimization, identified as a Waste Minimization Prioritization Tool. PBT criteria were 

used to score chemical substances. In 1999, EPA's Office of Solid Waste developed a list of 

substances using the PBT tool. At that time, NAMC provided comments on the limitations of 

th.e tool for application to inorganic substances, including metals. In 2007, EPA's Framework 

clearly identified the limitations of applying P and B for metals assessment. 10 

Strengths and Weaknesses ofthe Use of PDT Approaches and Standard Criteria 

Strengths -- The main advantage of the use of PBT is its simplicity. It requires only three 

measures that are easily determined and apply to many classes of organic compounds. The test 

procedures are standardized and utilized globally. Data bases now exist where the PBT values 

can be identified and used as needed. The development of the High Production Volume (HPV) 

program under the Organization for Economic Cooperation and Development (OECD) and by 

USEPA has generated additional PBT data, and the REACH regulation in Europe should provide 

yet additional information. All of these efforts lend themselves to making a vast amount of data 

available for assessing hazard and environmental fate of chemical substances using a PBT 

approach. The approach has the advantage and reputation of identifying problematic substances 

that are recognized internationally in the Stockholm Convention on Persistent Organic 

10 Framework at Section 5.2.5.4. 

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Pollutants. It is important to note that the PBTs addressed under the Stockholm Convention are 

limited to organic substances that also have the ability for global environmental transport (e.g., 

dioxins, furans, PCBs, organochlorine pesticides such as DDT, dieldrin, chlordane, etc.). It is 

important to recognize that not all organic PBTs have the potential for global transport. 

'Weaknesses -- The simplicity of the approach is also a drawback to its broad application. The 

PBT screening criteria assess only hazard and key environmental fate properties, not risk. A 

substance may pose PBT concerns,' but not present risk if exposure is controlled or is minimal. 

To assess risk, a PBT approach must additionally consider volume of production and release to 

the environment. PBT assessment provides information on the properties of the substance, but 

not the probability or likelihood of effects. Other disadvantages include the following: 

III PBT does not consider pathways and magnitude of entry to the 

environment. 

III Octanol-water partition coefficients (Kow) have been used as surrogates 

for measures of B. These measures do not consider the potential for 

metabolism and are not applicable to some classes of compounds, 

including metals, silicates, and other inorganic substances. 

III Measures of persistence typically focus on biodegradation and not other 

environmental loss mechanisms that can include hydrolysis, photolysis, 

complexation, burial in sediments, and remineralization. 

In addition, the approach does not consider the benefits of a given chemical substance. 

Why PST Criteria Are Not Appropriate for Metal Substances 

Specifically for metal substances, there are several disadvantages and reasons why PBT criteria 

have limitations to their use, which are outlined below. That is why NAMC supports an 

alternative approach to PBT assessment for evaluating metals and metal compounds, which is 

explained later in this testimony. 

11 

III Persistence: Persistence is problematic for metals because all metals and 

elements on the periodic table are conservedll and hence, persistent. The 

form and availability of the meta! can change depending on the 

Law of Conservation of Mass is a relation stating that in a chemical reaction, the mass of 

the products equals the mass of the reactants. See 

http://chemistry.about.comlod/chemistryglossarylaJconservmassdef.htm. 

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environmental conditions. They are also different for each metal element 

and this must be considered. Thus, setting a criterion such as a half life for 

degradation of 70% in 28 days in water automatically captures all metals, 

including those that are essential (iron, copper, zinc, etc). As a result, 

applying criteria designed for organics to metals can be misleading. A 

more discriminating approach is needed. This issue becomes significant if 

PBT criteria are used to identifY contaminants of concern and to introduce 

restrictions on commerce, transportation, and labeling. 

III Bioaccumulation: Unlike organic substances, bioaccumulation potential 

of metals cannot be estimated using octanol-water partition coefficients 

(Kow). Bioconcentration and bioaccumulation factors (BCFs and BAFs) 

are inversely related to exposure concentration and are not reliable 

predictors of chronic toxicity, food chain accumulation, or hazard. The 

inverse relationship between exposure concentration and BCF results in 

organisms from the cleanest environments (i.e., background) having the 

largest BCF or BAF values. This result is counterintuitive to the use of 

BCF and log Kow as originally derived for organic substances.!2 

III Toxicity: Metals are generally not readily soluble. Toxicity test results 

based on soluble salts may overestimate the bioavailability and the 

potential for toxicity for many substances, especially for the massive 

metals and insoluble sultlde and metal oxide fonns. Further, many 

organisms appear to regulate metal accumulation to some extent, 

especially for essential metals. 

Alternative Approach for Assessing Metal Substances 

In 2003, I chaired a workshop which was sponsored by the Society of Environmental Toxicology 

and Chemistry (SET AC), a professional society that supports practices for protection, 

enhancement. and management of sustainable environmental quality and ecosystem integrity. At 

the workshop. PST issues were discussed at length and reported out in a book. 13 Consensus was 

12 

13 

McGeer, J.e., K.V. Brix, D.K. DeForest, S.L Brigham, J.M. Skeaff. W.J. Adams and A. 

Green. 2003. Bioconcentration Factor for the Hazard Identification of Metals in the 

Aquatic Environment: A Flawed Criterion? Environ. Tax. Chern. 22(5): 1017-1037. 

Adams WJ, Chapman PM. 2005. Assessing the Hazard of Metals and Inorganic Metal 

Substances in Aquatic and Terrestrial Systems: Summary of a SET AC Pellston 

Workshop. Pensacola (FL). SETAC Press, Pensacola, FL, USA. 

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reached at the workshop that individual criteria, like PBT, are limited in their ability to assess 

hazard or to prioritize metal substances. The criteria are not linked or integrated and they 

attempt to identil'y or predict effects (hazard) using bioaccumulation and persistence as modifiers 

of toxicity, without fully incorporating other important fate characteristics, which for metals 

include speciation, complexation, precipitation, dissolution, transformation, and sedimentation. 

It was suggested that a more comprehensive approach be taken for both metals and organics in 

which a generic hazard ranking be sought using a "unit world" model. The aim is to incorporate 

partitioning, transport, reactivity, bioavailability, and exposure route information to give a single 

and transparent metric of hazard. It is essentially a "critical loading" approach in which an 

estimate is made of the rate at which a chemical must be introduced into a common defined 

environment to achieve a concentration in a target compartment (such as water or fish) that is 

deemed to be of concern from toxicity or regulatory objective viewpoints. An LC50 or no-effect 

level could be used. Hazardous substances will have lower critical emission rates. A group of 

metals and organics can thus be ranked for a common metric of hazard using this critical loading 

approach. Following the workshop, efforts have been on-going to develop and validate a Unit 

World Model. 14 This model is now available for use (www.unitworldmodel.net). 

Conclusion 

Any attempt to universally and uncritically apply PBT criteria to all chemical substances -- for 

example, to create lists of chemicals of concern -- would be scientifically inappropriate and 

would result in misleading if not erroneous outcomes. Similarly, since PBT information, by 

itself, cannot determine risk, such criteria should not be used in isolation as a basis for requiring 

regulatory action. If, regardless of these cautions, an attempt is made to base regulatory actions 

on PBT information for some substances, it is important to understand that persistence and 

bioaccumulation factors cannot be applied to metal materials because P and B criteria were 

developed for organic chemicals and are ill-suited to evaluate the hazards of metals. Instead, 

consideration must be given to an exposure concept of transtormation relative to the potential 

release of forms of metals that are bioavailable. 

Thank you for this opportunity. 

14 Farley, K. 2010. Validation of the Unit World Model. Presentation at the ICMM 

Technical Working Group Meeting, Raleigh-Durham, January 7, 2010. Manuscript I 

preparation, Manhattan College, New York. 

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Mr. RUSH. The chair thanks the witnesses again. 

And the chair recognizes himself now for 5 minutes of questioning of the witnesses. 

And, Dr. Greer, it is my understanding that if we know a given 

chemical is toxic and there is exposure and then we can determine 

the risk as defined by the national academics in their 1983 socalled Red Book they laid out the Federal risk assessment process. 

Risk assessment is ‘‘the characterization of the potential adverse 

health effects of human exposure to environmental hazards.’’ From 

that, Dr. Greer, can we assume that if a chemical is persistent, bioaccumulative and toxic that it is a PBT and there are known exposures so therefore there is a high risk? I have a couple of other 

questions that go along with that. When we know that there are 

PBTs and evidence of exposure, I understand that exposure can be 

important based on the geographic areas of specific populations, 

how should we address this concern? Can you answer both of those 

questions? 

Ms. GREER. Sure, let me clarify that it is not my position that 

risk assessment is not a valuable tool or that it is not important 

to look at both hazard and exposure, not at all but there are certain chemicals out there that meet the PBT criteria for which we 

already have evidence of exposure through biomonitoring of human 

blood or through looking at animals at the top of the food chain. 

And that combination, in my mind, is definitely sufficient to identify those chemicals for fast action so that the agency does not 

spend years and years deciding what level is dangerous but start 

asking questions about use reduction instead. What are do we have 

critical uses that we have to keep on the market? Do we have, you 

know, really the opposite, stupid uses that we could get rid of 

quickly and to start asking reduction questions rather than risk 

question. So I think that the real problem here is not so much the 

debate about risk assessment and exposure but really how to get, 

how to change TSCA so that it is not just about study, study, study 

but is about taking action instead. Asking the set of use production 

questions and exposure reduction questions instead of the questions just about hazard which is what the agency has, unfortunately, spent most of its 35 years doing. 

And when we look at the uses of these chemicals, we have to look 

at the patterns of exposure and the patterns of use. We know from 

experience that there are many communities with hotspots of exposure where certain chemicals have been used in large quantities 

and have accumulated. Certain patterns in diets that have hotspots 

of human exposure, et cetera. It is very hard to make a general 

safety determination that it is going to be okay here and not okay 

there because we usually lack the information about the widespread and spotty uses of these chemicals combines. I hope that answers your two questions. 

Mr. RUSH. Dr. Jones, I have about another minute and a half. 

Do you generally have a response to the questions? 

Mr. JONES. The same questions? 

Mr. RUSH. Yes. 

Mr. JONES. The agency believes that ultimately we need to evaluate chemicals based on their hazard, their exposure and their risk, 

and that the reason for that is that by addressing chemicals and 


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uses that have the highest risk, we are going to get the best protection for the country, and not spending our energies on exposure 

routes that may pose little or not risk but instead on those exposure routes that are going to present the highest risk. 

Mr. RUSH. Okay. The chair recognizes now Mr. Whitfield. 

Mr. WHITFIELD. Thank you, Mr. Chairman, and thank you all for 

your testimony. We appreciate it very much. 

Mr. Jones, back in 1991, there was a lawsuit, Corrosion Proof 

Fittings v. EPA, which evidently in the TSCA Act when you came 

up with the measure to correct the problem you use the least burdensome standard and evidently in that particular case, the EPA 

did not use the least burdensome standard. What is the difference 

in the standards in this in TSCA and in say the Clean Air Act? 

Mr. JONES. Unfortunately, I am not particularly expert at the 

Clean Air Act but I have a high degree of expertise in the pesticide 

regulatory framework, FIFRA. 

Mr. WHITFIELD. FIFRA, okay, let’s say FIFRA. 

Mr. JONES. Well, I am sorry. My expertise is in pesticides and 

in TSCA. 

Mr. WHITFIELD. Oh, okay. 

Mr. JONES. The pesticides program which is sort of similar, it is 

chemicals. 

Mr. WHITFIELD. Yeah. 

Mr. JONES. Thus the regular standard is a reasonable certainty 

of no harm for chemicals used on food and it is a basic risk benefit 

standard for chemicals that are not used on food. There isn’t a 

least burdensome requirement in those statutes. 

Mr. WHITFIELD. Okay, well, under TSCA when we talk about unreasonable risk, how do you define unreasonable risk? How do you 

determine something has unreasonable risk? 

Mr. JONES. Unreasonable risk under TSCA as it exists right now 

has been interpreted to be a risk benefit standard and that so if 

the risk of the use outweighs the benefits, it is determined to be 

an unreasonable risk. 

Mr. WHITFIELD. Okay, so it is a risk versus benefit. Now, and 

that is not always the standard in some other environmental laws, 

is it? 

Mr. JONES. That is correct. 

Mr. WHITFIELD. Okay and I would assume that Dr. Greer and 

Mr. Sturdevant and maybe Dr. Thompson would agree that the 

more stringent standard would be the best standard and would I 

be correct in that? 

Ms. GREER. I would agree that the track record shows that this 

standard has not been good for us. For example, in the case that 

you cite, it kept the agency from taking action against asbestos 

which I think is widely regarded as a, you know, a dangerous carcinogen. 

Mr. WHITFIELD. Yeah. 

Ms. GREER. It is not to say though that we don’t think that there 

are critical uses of toxic chemicals that will need to remain on the 

market. 

Mr. WHITFIELD. Right. 


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Ms. GREER. And so, you know, there needs to be an exit ramp 

for those uses so that we don’t jam ourselves into something unreasonable, in the common language, not in the legal language. 

Mr. WHITFIELD. Okay, all right, and I think we all agree on that, 

I mean, hopefully, that there are chemicals that are quite valuable 

and yet there is some dangers to most chemicals and, hopefully, we 

could when we rewrite this Act can come up with a balanced approach that would benefit everyone. 

Another question I had for you, maybe, Mr. Jones, or anyone else 

who wants to talk about it. The Toxic Release Inventory Program 

which I guess came about because of the Community Right To 

Know Act, and it is my understanding that EPA in the Toxic Release Inventory Program right now has something like 600 and 

some chemicals that are on that list. How are those chemicals selected? 

Mr. JONES. Largely, based on their toxicity, although there is a 

special way in which PBTs can be identified and actually have a 

lower reporting threshold then chemicals that are not PBTs. 

Mr. WHITFIELD. Yeah and who actually makes that decision? 

Mr. JONES. They are made by the administrator of the Environmental Protection Agency, and over the last 15 years multiple, at 

multiple points in time different administrators have made that determination. 

Mr. WHITFIELD. Yeah but you do have some lab somewhere doing 

some testing on animals to decide, is that correct? 

Mr. JONES. There is a wide range of toxicity information and 

sources of information. Some of it is generated by manufacturers. 

Some of it is generated by universities and some of it is generated 

at EPA laboratories. 

Mr. WHITFIELD. Yeah, well, you know, I am no expert in this but 

last night I was sitting around and I was looking at this inventory 

list, and I just looked down this list of 600 chemicals and I came 

across one called metiran, m-e-t-i-r-a-n, which maybe you call are 

familiar with but I wasn’t. And it is on the list of Communities 

Right to Know and yet when I read that toxicity part of the study, 

it says when rats were fed a thousand milligrams diet of metiran 

for 2 weeks, 5 days per week, no symptoms of illness were produced. No ill effect was observed in dogs that received 45 milligrams daily of this fungicide for 90 days, or 7.5 milligrams daily 

for almost 2 years. There were no negative effects. So I was just 

curious, how is it determined that this will be on the list of something that communities need to know about? 

Mr. JONES. I would need to go back and get some more information around that. I know metiran is a registered pesticide active ingredient so there would be a wide number of toxicity studies that 

have been generated to support its registration so I should be able 

to answer that question. 

Mr. WHITFIELD. Yeah, well, then do any—Dr. Greer, do you have 

any comment about that or you, Mr. Sturdevant? I mean, like I 

said, I am not a scientist and but it seems to me that if you give 

this particular substance—most of the decisions are made based on 

the animal studies is my understanding, and if you give animals 

that much and yet you decide to put it on there, I just wonder what 


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is the real standard for deciding? What is the precise standard to 

make that decision? 

Ms. GREER. I also don’t happen to know about that chemical but 

like Mr. Jones, I mean I know the criteria that the agency uses to 

get those chemicals on the list so there is something here that 

doesn’t meet the eye, and I would have to go back and then submit 

for the record what I think is the rationale for having that chemical on the Toxic Release Inventory. 

Mr. WHITFIELD. Yeah, well, is there—if you were at a Rotary 

Club in your hometown and you were explaining the criteria for 

placing a chemical on this inventory list, how would you in layman’s term explain it to them? 

Ms. GREER. Would you like me to? 

Mr. WHITFIELD. Yes. 

Ms. GREER. I would—in layman’s terms I would say they are 

chemicals that can harm human health or the environment. 

Mr. WHITFIELD. They can. Now, that is pretty vague it would 

seem but that is what you would say, is that correct? 

Okay, I am sorry. 

Mr. RUSH. I am going to recognize the gentleman from Maryland, 

Mr. Sarbanes, for 5 minutes. 

Mr. SARBANES. Thank you, Mr. Chairman. 

And thank you, Dr. Greer, for your answer just then because I 

am actually speaking to a Rotary Club this evening. If I get any 

questions like that, I will know what to say. 

Ms. GREER. I will come up with a second verb for you. 

Mr. SARBANES. I wanted to go right to this discussion you have 

been having about sort of rapid action versus study because I imagine that will be an important part of our discussion on the reauthorization and will probably lead to some tension of perspectives, 

as well. What do you have in mind when you talk about rapid action, and maybe you could speak to a category of chemicals that we 

could view as already having been sort of research tested and understood ad nauseam in terms of the toxic impact they have, using 

whatever combination of standards is appropriate, that we could 

really just get moving on in terms of this rapid action? So talk 

about the category and even some of the particular chemicals that 

you would identify for that rapid action and then what the rapid 

action would be that you envision? 

Ms. GREER. Well, in our opinion, there are several dozen chemicals, maybe two or three dozen chemicals, not hundreds or thousands or chemicals, but a relatively speaking handful of chemicals 

that have been extremely well-studied. They have been studied, 

many of these chemicals, literally for decades. In the case of a 

chemical like dioxin, you know, there are file cabinet rooms full of 

studies on these chemicals. It is not most chemicals, Mr. Sarbanes, 

I mean most chemicals we don’t have that amount of study, and 

so there are really two categories in my mind. The ones that have 

been extremely well studied, I would put a chemical like TCE on 

that, a chemical like formaldehyde on that, you know, that we have 

quite a bit of information. And then the second category would be 

some of the PBTs, some of the chemicals that we have known for 

years are, as one of the other testifiers said, you know, the genie 

is out of the bottle and they have come out and we are now in a 


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legacy mode of trying to do the cleanup. And for those two categories of chemicals, I would submit that we really don’t need more 

study. What we really need is an action plan to look at what the 

uses are and to phase-out or reduce the uses and exposures to 

those chemicals because one more study is not going to make the 

difference and we already have enough evidence to know that at 

certain concentrations they will cause problems. So would be the 

relative minority of chemicals relatively short list but ones that I 

think are very ripe for action given how long they have been already studied. 

Mr. SARBANES. Would you imagine identifying those explicitly in 

a reauthorized statute? 

Ms. GREER. Based on my experience of watching EPA over the 

years, we learned in other statutes then when that we made lists 

of chemicals it led to much faster action because the agency took 

a much, much longer time left to their own devices to do it. So 

based on experience with implementation really, I would strongly 

recommend that we put the list into the statute, yes. 

Mr. SARBANES. When you look internationally at some of these 

other conventions and protocols and regulatory regimes that exist, 

do you see that approach in place? 

Ms. GREER. Yes, that is right. When you look, for example, at the 

Stockholm Treaty, at the POPs Treaty, those chemicals were 

named and continue to be named in an ongoing process of adding 

more chemicals to the list. 

Mr. SARBANES. And then, Mr. Sturdevant, I was just intrigued 

by the approach you took. What was the pushback you were getting? Who, you know, you described various parties showing up in 

the State capitol. Describe a little bit why they were so resistant 

and where they are now in that you have taken steps. I mean it 

doesn’t appear that the economy of Washington State has collapsed 

due to the measures you have taken so maybe you could just talk 

about that a little bit. 

Mr. STURDEVANT. Yeah, well, the, you know, in fact, the when we 

identified an alternative to this flame retardant and some of the 

same companies that made the PBDE flame retardants also made 

the alternatives so there wasn’t anything really in terms of an economic impact in terms of jobs. There wasn’t any impact in terms 

of flame retardants. It was very interesting and, you know, it felt 

a little bit like a David and Goliath fight really with the resources 

that came to bear, very sophisticated resources there. And, you 

know, as the evidence continued to sort of go our way, the arguments changed and, you know, in the end it there was an attempt 

to put a deal together where okay, so if we are going to go ahead 

and take action on PBDEs, let us exchange that for greater fire 

safety standards in the State on other products basically sort of 

driving a new market. So, you know, I think that it was so about 

money, and it was about also I think setting a precedent, you 

know, that the first, this. It was a hard fight because it was the 

first ban on that product in the country and others followed and 

it was all about whether that first domino was going to topple or 

not. 

Mr. SARBANES. Thank you. 


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Mr. RUSH. I would like to ask before you respond we are going 

to take an additional 3 minutes for additional questions. 

As you can see, we know that the great gulf that we are going 

to have to cross for TSCA reauthorization is the bulk of chemicals 

on that, you know, either abandon or come up with another process 

of identifying that would include a ban in the legislation. 

And I would like to get your response, first of all, do you think 

that these chemicals should be banned in the next, chemicals specifically banned in the next and if you would take a moment or two 

to support your answer, your rationale and we will start with Mr. 

Jones. 

Mr. JONES. Well, the agency and the Administration has articulated a number of principles. There are five principles in all. The 

first principle is the chemical should be reviewed against the safety 

standard that are based on sound science and reflect risk-based criteria protection of human health and the environment. That is 

probably the principle that most is relevant to the question of 

should the statute itself ban chemicals. If it is done in a risk-based 

manner I think that might be consistent with the principle. If it is 

just a it just names them and bans them with any risk-based criteria related to that it would seem to be inconsistent with that 

principle. 

Mr. RUSH. Dr. Thompson, same question. 

Mr. THOMPSON. I think I would just echo those comments and 

just I would note that internationally under the Stockholm Convention, we do have a scientific review committee that really looks, you 

know, at these issues very closely, analyzes it, looks at the risks 

associated with the chemicals and they come forward with recommendations to the countries that participate in the agreements 

in terms of whether a chemical should, in fact, be banned or should 

it be restricted in some way, and whether exemptions should exist. 

So just to echo the comments from my colleague from EPA and 

note that I do think a very, there is sort of a very similar type of 

a procedure that we have internationally to actualize quite a similar outcome, I think. Thank you. 

Mr. RUSH. Mr. Sturdevant. 

Mr. STURDEVANT. I certainly don’t have the expertise to say what 

chemicals should be on that early action list but I would say that 

you need to look at a couple things. One is so how bad is it and 

if it is bad enough then I think bans are justified. The other question is are there alternatives and as Dr. Greer said is that use really important or necessary. So I think it is you have to look at both 

what it is providing and are there alternatives and if there are alternatives that are easily available, and I think it makes that decision a lot easier to make. 

Mr. RUSH. Dr. Greer. 

Ms. GREER. And I will be quick since I have sort of already answered this question. 

Mr. RUSH. Right. 

Ms. GREER. I do think that there are a number of chemicals that 

have a mature docket, so to speak, a Texas new docket that is quite 

complete and that statutory list would be helpful to get fast action 

on those chemicals as we reauthorize TSCA. 

Mr. RUSH. Dr. Cowan-Ellsberry. 


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Ms. COWAN-ELLSBERRY. When I worked within the UN on the 

protocol, that was one of the things that we did emphasize is that 

it needed to be risk-based, and I think I would also emphasize that 

any alternatives also need to be assessed because we don’t want to 

move in precipitously to something that could be worse. And having multiple management options and phasing them in as Dr. 

Greer said, getting rid of alternatives where they are maybe not 

necessary, would probably be an easy way to go. 

Mr. RUSH. Dr. Adams. 

Mr. ADAMS. Yes, thank you. 

Let me draw upon the experiences currently in progress in Europe at the moment under the REACH legislation. Under that process, chemicals such as Dr. Greer has mentioned and ones that are 

well-known have been identified and put on a list for further review, not further study. The point being is that the studies are 

done. They have looked at the toxicology. They have determined 

them to be hazardous and potentially causing risk but there is then 

a careful review of the use of the substance, its release to the environment and the cost benefit. So I would favor rather that kind of 

approach rather than just prescriptively writing substances into 

the legislation. 

Mr. RUSH. Thank you. 

The chair now recognizes Mr. Whitfield for 3 minutes. 

Mr. WHITFIELD. Yeah, I would ask Dr. Greer what do you say to 

what Dr. Adams just said there? Do you agree with him or not? 

Ms. GREER. I think, well, you know, it is interesting. I think that 

what the question really comes down to who is in the best position 

to make some of those evaluations and decisions? Are there some 

chemicals that the Congress can take a look at and in discussion 

with effected parties and with EPA say, you know, okay this is a 

list. This is the chemicals. I think that we can do that and that 

given how long it has taken the agency which I might add really 

every time they can tentative decision, you know, is plagued by 

comments and delay, et cetera, et cetera, I think we could make 

faster work for them by looking at some of those chemicals so I 

don’t think I have a disagreement at all in concept. I think the 

question on the table for us as we move forward for TSCA reauthorization is where are those conversations taking place and lets 

keep an eye on how can we really make this system work. What 

would be the best solution to make the system work? 

Mr. WHITFIELD. Now, Dr. Adams, I know in your testimony you 

said that a hard and fast PBT criteria would ignore scientific nuances like how a chemical or metal reacts in a particular environment or based upon climate or hydrology and other factors. So you 

would not want to just see a list to be banned by Congress, I am 

assuming? 

Mr. ADAMS. Well, I think there are a few chemicals. If you consider the POPs Treaty or the POPs Convention, for example, you 

will see some substances in there that are identified as being extremely hazardous and not to be traded in commerce. 

Mr. WHITFIELD. So there are some things we could easily mention. 


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Mr. ADAMS. There are a few things out there that are kind of nobrainers, if you will, okay and why not. I mean and many of them 

are PCBs that are not manufactured anymore so it is an easy one. 

Mr. WHITFIELD. Right. 

Mr. ADAMS. But there are some others that could be an easy 

choice but by and large, I think we want to consider the uses and 

we want to consider the risk of substances. 

Mr. WHITFIELD. Right, now, could you give me a couple of examples that there would be universal agreement on? 

Mr. ADAMS. Well, if you look at many of the chlorinated pesticides that were used in the ’60s and ’70s, so that is Lindane, 

Aldrin, Methoxychlor, DDT, DDE, so a number of those kinds of 

compounds are recognized internationally as being unacceptable. 

Mr. WHITFIELD. Now, let me just ask one other question that 

maybe someone could respond to. We have heard a lot of discussion 

today about implementation legislation in order to abide by some 

of these treaties. Can someone just give me a quick synopsis of 

what we are talking about there? Mr. Jones, do you want to do that 

or Dr. Thompson? 

Mr. THOMPSON. I could give you maybe some brief highlights I 

think of what is needed. I think in particular there are a number 

of provisions in the agreements that call for parties to do specific 

things. Under the Stockholm Convention, for example, we would 

have difficulties preventing the manufacture or production of 

chemicals for export and use in other countries. There are a number of other provisions that are related to both export controls and 

import controls for the different agreements that current domestic 

authorities don’t really cover. And finally, there are some waste-related provisions to prevent the reuse and recycle of persistent, organic pollutants that we would need some tidying up domestically 

to implement those obligations. 

Mr. WHITFIELD. Okay and how many PBTs have actually been 

banned under TSCA since its inception? Have any? 

Mr. JONES. The most notable one is the PCBs were banned by 

statute. 

Mr. WHITFIELD. By statute, yeah. 

Mr. JONES. The agency has only taken five other sort of major 

regulatory bans since the statute was implemented and I am not 

sure if any of them are PBTs. 

Mr. WHITFIELD. Okay, thank you. 

Thank you. 

Mr. RUSH. The Chair recognizes Mr. Sarbanes for an additional 

3 minutes. 

Mr. SARBANES. Thank you, Mr. Chairman. 

I am just thinking about the different standards by which one 

could judge our efforts to limit some of these toxic chemicals and 

their use and our exposure to them and so forth, and there are all 

kinds of standards. I mean there is the legal standard that would 

be used in a tort case, for example. There is the standard that the 

agency sets which can sometimes interfere with or enhance the 

legal standard where we use to protect or create a higher legal 

standard. And I guess there is an industry burden standard that 

operates in our thinking but the one that I am thinking about the 


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most is what I would just call the kind of member of public consumer commonsense standard. 

There are a lot of situations in which these other standards I 

mentioned from the standpoint of the consumer, if they are more 

aggressive, they are seen as unreasonable, in other words consumers will say well, you know, that is going a little bit too far. 

But in this context, it is hard for me to imagine that a member of 

the public understanding some of the risks that are involved here 

would not want to adopt the most aggressive standard relative to 

all these others that was available. And, you know, I imagine people looking back on a hearing like this, we are on a reauthorization 

of TSCA that doesn’t take this step of identifying obviously dangerous chemicals out of the gate, and putting in place a rapid action strategy. I imagine the reaction of the public would be to say, 

you know, excuse me, what didn’t you understand? What more did 

you need to know to take aggressive steps to address this problem? 

So going forward, I am going to be pretty strong on the notion that 

we need to get out of the gate quickly with respect to those chemicals, that category of chemicals where we have a lot of knowledge 

at our fingertips. 

My question was this, describe what you think will happen and 

it sounds like it may already have begun when our standards fall 

further and further behind the standards that are being imposed 

other places. Do we become a dumping ground? I mean, what that 

gap has got to produce some significant and harmful consequences 

to it and if anybody would like to speak to that, I would welcome 

it. 

Yes, Dr. Greer. 

Ms. GREER. Yeah, I think there are three things that you see and 

we have actually already seen all three of them. The first is that 

we could become a dumping ground. We used to worry about when 

the United States took action on a chemical that was unsafe that 

maybe that chemical would end up in the Third World, in the developing world and that that would be, you know, something that 

we would feel morally responsible for because we had decided it 

wasn’t safe enough for us but it could go to Africa or some place 

where that government was not up-to-speed on that. Well, now we 

face the real prospect that Europe will ban certain things from 

products and they will be okay here in the United States because 

Europe is ahead of our system and that we, the United States of 

America could become a dumping ground for things that are not 

safe enough for Europe. 

The other two things that you will see, I think and have already 

seen is that States will start to take action where they have problems, either because they have hotspots or problems in certain rivers or in certain communities, or because their citizens are particularly upset and sensitized to this. And we will get the sort of patchwork regulation that is not really good for industry because different States have different systems and it all gets very confusing. 

And the third that you will see, which I think we are already 

seeing, is what we call retail regulation which is that some in the 

private sector will say we don’t want to sell this. This is what happened with BPA and plastic bottles in baby bottles where they 

didn’t want to wait for the government to take action because their 


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market was being threatened by the fact that customers didn’t 

want BPA in their baby bottles, and so they took action without 

the government for their own purposes, for their own business purposes so that they could say to their customers, we have our own 

systems in place to make things safe for you, and you can feel 

happy to come shop here and buy those things, and that is sort of 

random. It is a chemical of the weak system that we think if we 

had a well-functioning government system it could be more orderly, 

more systematic, et cetera, et cetera. So I think those are the three 

consequences that jump to my mind immediately and I actually 

think we are seeing all three of them already because, of course, 

the system has been broken for some time now. 

Mr. SARBANES. Thank you. 

Mr. RUSH. The chair thanks the gentleman. 

The chair wants to make sure that you care about our purposes 

and our continuing work, and the focus of our continuing work, and 

this will be on reforming TSCA, and not necessarily reauthorizing 

TSCA. We want to make sure we are clear about that. We want 

to reform TSCA and it means a lot, you know, and we don’t have 

the right idea of how we are working on it and we might wind up 

someplace else and we certainly can’t afford to wind up someplace 

else. We need to reform TSCA. 

With that said, I want to again thank the witnesses for sacrificing your invaluable time with us. You have been very informative and very enlightening toward this committee, subcommittee, 

and I for one, feel much more empowered and enlightened because 

of your comments and your answers to the questions. I want to 

thank you again for being here with us. 

And that said, without objection, I would like to submit into the 

record some supporting action on PBTs from the Safer Chemicals 

Healthy Families, they sent letters. The Environmental Working 

Group has sent letters. The National Council of Churches has sent 

letters. The Pesticide Action Network of North America, we heard 

from them in the form of letters and other communications, and 

the American Public Health Association. It has already been ordered that the American Chemistry Council letter be included, and 

we have a letter also from the National Petrochemical and Refiners 

Association. And lastly the chairman of the full committee, Chairman Waxman, has an opening statement that we would also enter 

into the record without objection. And so without objection, so ordered and these and other associated matters be entered into the 

record. 

[The information appears at the conclusion of the hearing.] 

Mr. RUSH. The chairman would also like to keep the record open 

for another 2 weeks and would ask the witnesses if there are any 

members of the subcommittee who want to ask questions in writing, if you would get to you and if you would in a timely manner 

as promptly as you can, respond to those questions in writing. It 

would certainly be an enormous help to this subcommittee. Thank 

you very much. 

And the subcommittee now stands adjourned. 

[Whereupon, at 12:54 p.m., the Subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 


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Statement of Rep. Henry A. Waxman 

Chairman, Committee on Energy and Commerce 

"TSCA and Persistent, Bioaccumulative, and Toxic Chemicals: 

Examining Domestic and International Actions" 

Subcommittee on Commerce, Trade, and Consumer Protection 

March 4, 2010 

Today's hearing examines substances used in commerce 

known as persistent, bioaccumulative, and toxic chemicals. I 

commend Chairman Rush for holding this important hearing and 

I want to welcome Representative Whitfield to his first hearing 

of this Congress as Ranking Member. 

This is the Subcommittee's third hearing reviewing the 

Toxic Substances Control Act, TSCA (pronounced "TOS-KA"), 

the nation's primary law for ensuring the safety of industrial 

chemicals. At the first hearing, the Committee learned of the 

widespread agreement among industry, labor, and 

nongovernmental organizations that TSCA needs to be 

reformed. At the second hearing, we heard testimony on how to 

prioritize the vast number of chemicals in commerce for which 

we do not have health and safety information. Today's hearing 
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discusses how to proceed with a set of chemicals that most agree 

are at the top of the list of concern. 

These hearings are helping us determine how best to 

modernize TSCA and fix its many flaws. In addition to these 

hearings, we have been working closely with our colleagues in 

the Senate and will be reaching out to the many stakeholders in 

the TSCA process. Just like Chairman Rush, I am hopeful that 

TSCA reform can proceed on a bipartisan basis and with 

continued input from stakeholders. We all want legislation that 

improves protections for public health and the environment, as 

well as continued innovation and job production. 

I thank all of the witnesses for being here today and look 

forward to hearing their testimony. 

Thank you. 

2 
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Opening Statement for "TSCA and Persistent, Bioaccumulative, and Toxic 

Chemicals: Examining Domestic and International Actions" 

for Rep. Kathy Castor, FL-l t 

• Thank you, Chairman Rush, and good morning to my 

colleagues. We are here today because comprehensive 

TSCA reform has been put off for a generation. 

• We now have an opportunity to confront the threats that 

persistent toxic chemicals pose and lead the way forward on 

TSCA reform. 

• I am looking forward to hearing the testimony ofthe 

witnesses, and I thank them for their contributions to this 

important process. 

• In] 976, when the Toxic Substances Control Act was passed, 

there were already more than 60,000 chemicals in production 

in the United States. 

• We knew very little then about what health and 

environmental impacts these chemicals were having. 

• But instead of taking a cautious approach with regards to 

protecting the public from any potential adverse affects, we 

placed the burden of proof that these chemicals were safe on 

the chemical companies that manufactured them. 

• This approach to consumer protection led the EPA to require 

testing on a mere 200 chemicals, despite the years of solid 

science that has shown that many are, in fact, highly toxic. 

• Even more concerning, the EPA today regulates just 5 of the 

more than 80,000 chemicals now in circulation. 

• PBTs pose an especially worrisome threat to our 

communities because they can build up in the food chain and 

the human body and linger for years, increase the risk of 

chronic disease, and spread across the globe. 

• The good news is, we know much more now than we did in 

1976. 

• We know that the international community has spoken out on 

chemicals reform because both developed and developing 
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nations are experiencing some of the dangerous effects of 

these toxic substances. 

• We also know that environmental chemicals, including 

PBTS, are widespread in humans and actually tend to be 

higher in Americans than the people of other nations. 

• The Stockholm Convention, which the U.S. has signed, 

created international agreement that persistent organic 

pollutants need to be reduced or eliminated across the globe. 

• But Congress hasn't taken the steps to implement this 

agreement, along with others that would provide regulatory 

structure to the chemicals industry and much-needed 

safeguards for our communities. 

• So, I call on my colleagues to implement these international 

treaties and to finalize comprehensive TSCA reform. 

• After 34 long years, it's time to put this regulatory wilderness 

behind us. 

• It's time to move beyond analysis and take action, starting 

with the worst offenders, including PBTs, which have been 

linked to breast cancer, brain cancer, asthma, autism, 

reproductive disorders, and birth defects. 

• It's time to place the burden of proof on the chemical 

companies where it belongs and move away from the 

"research and delay" strategy that has benefited the chemical 

industry and done untold harm to consumers. 

• It's time to pursue international agreements that will prevent 

the United States and its most vulnerable communities from 

becoming the global dumping grounds for toxic substances 

like PBTs and formaldehyde. 

• There is too much at stake, something we know now, and can 

no longer make excuses for. 

• Thank you all. I look forward to the testimony of our 

witnesses, and I yield the balance of my time. 
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ONE HUNDIlCO f:.-LEVENTH CONGRr:s~: 

((ongress of tbc 7Mniteb $tates 

ji}onse of i'\rpresmtiltiu~% 

COMMITTEE ON ENEliGY AND COMMERCE 

2125 RAYBUPJ\r' HOUSE O;:FiCE BUr~DING 

WASIiiNGTON, DC 20515-6115 

8nc)rg jeOI) I!) 181 C0.j 1QliSG .guv 

MEMORANDIIM 

March 2,2010 

))["0/>,8101.1f<AS 'lANK;NG \1b<tF1f,R 

'CCO"CH'A'W'"' 

To: Subcommittee on Commerce, Trade, and Consumer Protectiou Members and Staff 

Fr: Subcommittee on Commerce, Trade, and Consumer Protection Staff 

Re: Hearing on "TSCA and Persistent, Bioaccumulatiw, and Toxic Chcmicals: 

Examining Domcstic and International Actions" 

On Marcil 4. 2010. at 10:00 a.m, in room 2322 ortlle Rayburn House Office Building. 

the Commerce, Trade. and Consumer Protection Subcommittee will hold a hearing entitled. 

"TSCA and Persistent, Bioacclll11ulative. and Tm.ic Chemicals: Examining Domestic and 

International Actions:' This hearing will examine the efforts taken to protect health and the 

environment from the subset of chemicals that meet the criteria for being labeled as persistent. 

bioaccumulative. and toxic (PBT). how the Toxic Substances Control Act (TSCA) I is currently 

being used to manage these chemicals. and how the TSCA process might be improved. 

I. BACKGROUND 

TSC A was enacted in 1976 to address the public health risk of chemicals used in 

commerce. TSCA requires the Environmental Protcction Agency (EPA) to analyze new 

chemicals for their safety. and authorizes EPA to restrict or ban the use of new or existing 

chemicals that pose an "unreasonahle risk" to public health or the environment The 

Subcommittee held two hearings on TSCA in 2009. 2 with the latter focusing on prioritizing 

chemical substances for safety determination. 

I 15 U.s.c. § 260 I et seq, 

2 Subcommittee on Commerce. Trade. and Consumer Protection, Hearing on RevisiTing 

Ihe Toxic Substances Control Act o1I976. Illth Congo (Feb. 26. 2009): Subcommittee on 

Commerce. Trade. and Consumer Protection. Hearing on Prioritizing Chemicals/or Sare~)! 

Determination. II Ith Congo (Nol', 17.2009). 
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Chemicals with certain properties can be particularly problematic for health and the 

environment. Persistent chemicals are highly resistant to degradation in the em'ironment and can 

spread across the globe. Bioaccumulative chemicals can build up in the food chain and in the 

human body. Toxic chemicals cause adverse health cffects in cxposed individuals. Chemicals 

with all three characteristics (PBTs) are considered to be particularly harmful. Exposure to PBTs 

have been associated with canccr. neurotoxicity. reproductive and developmcntal toxicity. and 

genetic mutations. Even with controls to restricl or el iminate their use. they can remain 

unchanged as long-lasting contaminants in the global environment. 

A recent study estimated there are 610 persistent and bioaccumulative chemicals 

currently used in commerce:' Of these. many are also known to be toxic. Examples ofPBTs 

include: chemicals such as polychlorinated biphenyls (PCBs). certain brominated flame 

retardants, and certain pcrtluorinated compounds; metals such as lead. mcrcury and cadmium; 

and fragranccs such as musk xylene. In addition. many pesticides arc PBTs. though pesticides 

are outside the scope ofTSCA because they arc regulated under the Federal Insecticide. 

Fungicide and Rodenticide Act (FIFRA). 

II. DOMESTIC ACTIONS 

J, Federal Actions 

In the late 1990s. the EPA initiated actions to consider PBTs uniquely from other toxic 

substances. In 1998. EPA published a draft strategy "to further reduce risks to human health and 

the environment from existing and future exposure to priority persistent. bioaccumulative. and 

toxic (PBT) pollutants,'·4 In 1999. EPA lowered the reporting thresholds for specific PBTs 5 and 

provided guidance on reporting these chemicals in 2001.° Also in 1999. EPA published a policy 

statement that created a PBT category for new chemical substances under TSC A Section 5 pre-

.; Howard PII. Muir DCG.1nde11lifj'ing Sell' Persistent and BioacclImulatil'e Organics 

Among Chemicals in COl/lmerce. Environmental Science and Technology (Jan. 22, 20J 0). 

4 Environmental Protection Agency. "ill/timedi" Strategy/hI' Priorily Persistenl, 

Bioacclll11ulative. and Toxic (PBT) Chemicals. 63 FecI. Reg. 63926 (Nov. 17. 1998) (Notice of 

Availability and Solicitation of Public Comment). 

, Certain chemicals are reported in the Toxic Release Inventory as authorized under the 

Superfund Amendments and Reauthorization Act. Emergency Planning and Community Rightto-Know Act of 1986, Title I II of the Superfund Amendments and Reauthorization Act. Pub. L. 

No. 99--199. 

(, Environmental Protection Agency. Emergency Planning and Community Right-ToKnoll' Act-- Section 313: Guidance for Reporting Toxic Chemicals: Pesticides and Other 

Persistelll BioacclIlIIlIlatil'c Toxic (PBTI Chemicals (Aug. 200 I). 

2 
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manufacture notice (PMN) provisions. 7 [n 2002. EPA finalized a tool to predict whether a 

chemical may meet criteria for being labeled as a PBT. even when data is limited. 8 

EPA has begun efforts to set baseline contamination levels to be able to analyze whether 

actions have been effective in reducing PBTs in the environment. In ::009. EPA published the 

National Lake Fish Tisslle Study examining 268 PBTs. demonstrating for the first time that 

certain PBTs are common water pollutants in the continental U.S. 9 In particular, mercury and 

PCBs were detected in all fish samples. PBTs account for 97% of all fish consumption 

advisories in 2008. 10 Future studies \\ ill need to determine trends in contamination levels in 

U.S. lake fish. 

Levels of clwironmcntal chcmicals including some PBTs are measured in humans and 

analyzed by the Centers for Disease Control and Prevention. II In their t(Jurth report released in 

December 2009. PFCs and PBDEs were measured for the tirst time. and have been found to be 

"widespread" in humans. Comparing these levels to that found in other countries, U.S. levels 

tend to be higher. 

In September 2009. EPA Administrator Jackson announced a new plan for improving 

chcmical managcment under current law. 12 which was followed by a December 2009 

announcement of action plans on tOUl' groups of chemicals. Three of the four action plans are for 

PBTs: long-chain perfluorinated chemicals (PFCs) used in stain-resistant or non-stick products, 

polybromodiphenyl ethers (PBDEs) lIsed as flame retardants. and short-chain chlorinated 

paraf1ins (SCCP) and other chlorinated paraffins used in metalwork, as plasticizers. and as flame 

retardants. 13 

2. State Govemment Actions 

7 Environmental Protection Agency. Cat<'gOl:v/or Persistent. Bioaccul11ulative, and Toxic 

Nell' Chemical Substances. 6.:1 Fed. Reg. 60194 (Nov. 4. 1999) (policy statement). 

8 Environmental Protection Agency, PET ProfileI' (online at 

www.epa.gov/oppt/sf/tools/pbtprofiler.htm) (accessed Feb. 3. 20 I 0). 

'I Environmental Protection Agency. National Lake Fish Tissue Sludy (Sept. 2009) 

(online at \V\V\V.epa.gov/waterscienceifish/study). 

10 Environmental Protection Agency. 2008 Biennial ,\/alional Listing ofFish Advisories 

(Sept. 2009) (online at \\\\ \V.epa.gov/waterscience/fishiadvisoriesitech2008.pdt). 

II Centers for Disease Control and Prevention, Fourth National Report 0/1 Human 

Exposure to Em'ironmenwl Chemicals (Dec. 2009). 

12 Environmental Protection Agency, Enhancing Existing Chemical Afanagclllellf 

Program (online at www.epa.gov/opptlexistingchemicals/pubs/cnhanchems.html) (accessed 

Nov. 13.2009). 

13 Environmental Protection Agency. Existing Chemicals Action Plans (online at 

www.epa.gov/oppt/cxistingchell1icals/pubs/ecactionpln.html) (accessed Jan. 25. 20 I 0). 

3 
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Washington State is currently the only state in the nation that has a policy to reduce use, 

releases, and exposure to PBTs within its borders. l-l This PBT Rule. adopted in 2006. establishes 

criteria to identify and list PBTs. and establishes criteria for selecting PBTs for action to protect 

health and the environment. Many other States. including Maine, Maryland, Massachusetts, 

Penllsylvania. South Carolina. and Virginia. have adopted chemical-specific legislation or 

policies. including on specific PBTs. I

) 

III. INTERNATIONAL ACTIONS 

Due to the long-range transportation of PBTs. there is general acceptance that there must 

be a collective international effort to manage their use and release into the environment. There 

are three relevant international conventions regarding PBTs. The 1998 Rotterdam Convention 

on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in 

International Trade (PIC Convention) provided a commitment to a shared responsibility for 

protecting health and the environment in international trade and information exchange of certain 

hazardous chemicals. 16 In 1998. the Convention on Long-Range Transboundary Air Pollutants 

(LRTAP)17 adopted a POPs protocol to provide a reduction or elimination ofprodllction and usc 

of certain PBTs. IS The 2001 Stockholm Convention for Persistent Organic Pollutants (POPs 

Convention) provided a shared commitment to reduce or eliminate releases of certain PI3Ts from 

intentional and non intentional sources. 19 The LRTAP POPs Protocol entered into force in 2003. 

and the PIC and POPs Conventions entered into f()fce in 2004. The United States has signed the 

PIC Convention, the LRTAP POPs Protocol, and the POPs Convention. but Congress has not 

successfully passed legislation to implement them. ell Recently. a number of organizations have 

again called on the United States to implement these treaties. cl 

14 Washington State, Chap!er 173-333 WAC. Persistent Bioaccul71ulatil'e Toxins (Jan. 13. 

2006) (online at w\\IV.ecy.wa.gov/biblio/\\ac 173333.html). 

I) Environmental Council of the States. Stale Experiences with Emerging Contaminants: 

Recommendations/or Federal Action (Jan. 2010) (online at 

ww\\.ecos.org/files/3959 _file_January _20 I 0_ [COS _ Green_ Report.pdf). 

16 Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous 

Chemicals and Pesticides in International Trade (Sept. 10, 1998). See www.pic.int. 

1979), 

17 Geneva Convention on Long-Range Transboundary Air Pollutants (LRT AP) (Nov. 

18 LRT AP Aarhus Protocol on Persistent Organic Pollutants (June 24. 1998). 

19 Stockholm Convention 011 Persistent Organic Pollutants (May 22. 200 I). 

cO S. 519; H.R. 3849. I 09th Congo (2006); H.R. 4591. 1091h Congo (2006): H.R. 4800. 

109th Congo (2006): H.R. 6421. 109th Congo (2006); S. 2042. 109th Congo (2005): S. 1486, 

108th Cong. (2004): H.R. 4935. I 07th Congo (2002); S. 2118. 107th Congo (2002): S. 2307. 

I 071h Congo (2002). 

cl See Letter from Daryl Ditz. et al. to Secretary Hillary Rodham Clinton and 

Administrator Lisa P. Jackson (Dec. 16, 2009) (online at 

www.cieLorg/Publications/TSCA_POPs_16Dec09.pdf); The National Congress of American 

4 
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In addition. u more regional international agreement between the US and Canada is the 

1997 Great Lakes Binational Toxics Strategy developed to eliminate PBTs in the Great Lakes 

region. 22 The 2009 Siale oUlle Greal Lakes report describes recent trends for many indicators. 

including fish concentrations ofPBTs. 23 This report sho\\s a decrease in certain contaminants 

such as PCBs. but no improvement in other contaminants such as mercury. The authors of this 

report highlight thc need to track concentrations for emerging concerns such as PFCs and 

PBDEs. The Obama Administration recently released a 5-year Great Lakes Restoration 

initiath'e Action Plan highlighting a concern for toxic substances. and PBTs in particular. \\ ith 

the goal to virtually eliminate "the release of any or all persistent to-.:ic substances (PTS) in to the 

Great Lakes basin ecosystem:·24 

IV. WITNESSES 

Jim Jones 

Deputy Assistant Administrator 

Ot1ice of Prevention. Pesticides and Toxic Substances 

Environmental Protection Agency 

John Thompson 

Division Director 

Office of Environmental Policy 

Bureau of Oceans. Environment and Science 

Department of State 

Ted Sturdevant 

Director. Department of Ecology 

State of Washington 

Linda Greer 

Director 

Indians. Resolulion iiPSP-09-021: Protection (Jf'the Health and Human Rights (~f Present and 

Fulure Generalions Ihrough Ralification alld illlpicmel1lafion by Ihe Uniled Slates "fthe 

Stockholm Com'ention 011 Persislent Organic Folllllanis (2009) (online at 

www.ncai.org/fileadmin/resolutions/PSP-09-021_linal.pdf); Letter from Andrea Kidd Taylor. 

Member. American Public Health Association Executive Board, to Congressman Wa-.:man (Feb. 

18, 2010); Letter from Safer Chemicals Health Families to Congressman Bobby Rush (Feb. 23. 

2010); Letter from Pesticide Action Network North America to Congressman Bobby Rush (Feb. 

24.2010). 

22 Great Lakes Binational To-.:ics Strategy (online at www.epa.gov/glnpo/bns/index.html) 

(accessed Feb.!. 2010). 

23 Environment Canada and United States Environmental Protection Agency. Slate of the 

Grea! Lakes 2009 (online at binational.net/solec/sogl2009/S0GL_ 2009 _ en.pdf). 

2·\ Great Lakes Restoration initiative Action Plan. FY 201 O-f"}' 201-1 (Feb. 21. 20 10). 

5 
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Ilealth and Environment Program 

Natural Resources Defense Council 

Christina Cowall-Ellsberrv 

CEc Consulting . 

Former Principal Scientist 

Environmental Sciences Department 

Procter & (jamble 

William J. Adams 

Chairman. North American Metals Council 

Staff contact: Rebecca Brown at 202-226-2424. 

6 
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!J • ...,_~ Safer Cllemicais 

r.'Y Healthy Families 

February 23,2010 

Honorable Bobby L. Rush, Chairman 

Subcommittee on Commerce, Trade and Consumer Protection 

Committee on Energy and Commerce, U.S. House of Representatives 

2125 Rayburn House Office Building, Washington, D.C. 20515 

CC: Chairman Henry Waxman 

Chairman Frank Lautenberg 

Senator James Inhofe 

Chairwoman Barbara Boxer 

Administrator Lisa Jackson 

Dear Chairman Rush, Ranking Member Radanovich and Members of the Subcommittee, 

Thank you for scheduling the February 11 th hearing, "Examining Domestic and 

International Actions on Persistent, Bioaccumulalive, and Toxic Chemicals (PBTs) " 

which was cancelled due to the snowstorm. We are writing to share our concerns about 

PBTs as members of the Safer Chemicals, Healthy Families coalition and allied 

organizations, who represent millions of parents, consumers, health advocates, and 

communities from around the country (www.saferchemicals.org). 

Urgent attention is needed to address the elass of chemicals known as Persistent, 

Bioaccumulative, and Toxic Chemicals, or PBTs. This class ineludes many of the most 

notorious chemicals ever studied - ehcmicals such as dioxins, mercury, lead, cadmium 

and polychlorinated biphenyls (PCBs), the dangers of which we have known for some 

time, as well as relative newcomers such as polybrominated diphenyl ethers (PBDEs) 

widely used as flame retardants and a variety of per fluorinated chemicals (PFCs) used to 

impart stain or moisture resistance to textiles and paper packaging or to produce nonstick 

cookware. 

PBTs are uniquely dangerous because they pose a triple threat. They persist in the 

environment for long periods of time and can be transported long distances: they 

accumulate in living organisms and increase in concentration as they move up the food 

chain; and, they are highly toxic, often at very low levels of exposurc. 

Because they exhibit all three of these hazardous properties, PBTs are inherently unsafe. 

And because releases of evcn small amounts ofPBTs will eventually lead them to build 

up to very high levels and in locations 0 [ten far removed from their point of use or 

release, traditional risk assessment methods cannot be used to effectively support 

regulatory action on PBTs. Because risk assessments require a quantification of exposure 

levels, they cannot adequately evaluate the harm posed by PBTs, the levels of which will 

continue to rise in people or other organisms, even after the contaminant ceases being 

released into the environment. 
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Moreover, requiring such chemicals to undergo expensive and time-consuming risk 

assessments would only delay taking needed action on a class of chemicals for which 

there is already broad scientitic agreement regarding the serious threat they pose to 

human health and the environment. 

As you consider policy options for modernizing the Toxic Substanccs Control Act 

(TSC At wc urge you to support immediate action to address these most dangerous of 

chemieals to which people are being exposed, PBTs should be phased out of commerce 

on an expeditious but reasonable time line, with exceptions allowed only for critical uses 

that lack viable alternatives. In addition, new PBTs should not be approved for use in 

commerce under a reformed TSCA. 

We have experienced first hand in our communities the devastating impacts PBTs can 

have on wildlife and people. For example: 

In the Northwest, Puget Sound's declining orca whales have become one of the 

most contaminated populations of marine mammals in the world, in part because 

of PCBs found in the Puget Sound food chain. PCBs are known endocrine 

disruptors and probable carcinogens that become highly conccntrated in the fatty 

tissues of top predators. PCBs arc the only chemical banned under the original 

TSCA, yet more than 30 years later they continue to pollute the environment. 

In the Great Lakes, the levels ofPBDEs in walleye and lake trout rose 

exponentially from 1980 to 2000, doubling every 3-4 years. Similarly, PBDEs in 

Great Lakes region herring gull eggs increased 60-fold between 1981 and 2000. 

In Maine, whieh is downwind from all the other states, common loons have the 

highest levels of mercury in the country and thc eggs of peregrine falcons have 

among the highest levels of the decaBDE flame retardant ever recorded. 

A growing body of scientitic evidence links PBT chemicals to a wide range of serious 

human health problems, including early onset of puberty, infertility, endocrine disruption, 

learning disabilities, behavioral disorders and certain cancers. And scientists are now 

finding evidence that these chemicals contaminate people at levels that are cause for great 

concern. For example: 

• A 2009 study of 302 women residing in North Carolina found that three quarters 

of them had PBDEs contaminating their breast milk. The highest levels were 

found in women ages 25-29, in the prime of their child-bearing years. PBDEs can 

have negative impacts on behavior, brain development and reproduction. 

The Arctic is a hemispheric sink for PBTs, which are transported long distances 

via atmospheric and oceanic currents. Arctic Indigenous peoples reliant on 

traditional diets of fish and marine mammals are among the most highly exposed 

people on earth. A study of the Yupik people ofSt. Lawrence Island in Alaska 

found that they carry PCBs in their blood at levels that are 6-9 times higher than 

the general population in the lower-48 states. 
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The Environmental Proteetion Ageney (EPA) estimates that more than 300,000 

newborns each year may have inereased risk oflearning disabilities assoeiated 

with in utero exposure to methylmercury. EPA scientists indicate that research 

has found no safe level of mercury exposure. 

Most disturbing is that we now know people are being exposed to many of these PBT 

chemicals as a result of their use in everyday consumer products such as: 

PBDEs and other brominated flame retardants are found in furniture, electronics, 

and textiles. 

PFCs are widely used in food packaging, clothing and other textiles and 

cookware. 

Governments at all levels are already taking action to phase out the use of these 

particularly dangerous chemicals. Congress should follow their lead. For example: 

Under the Great Lakes Water Quality Agreement of 1978 and subsequent Great 

Lakes BiNational Toxics Strategy, the U.S. and Canada pledged to seek the 

virtual elimination of the discharge of persistent toxic substances to the Great 

Lakes. 

32 states have passed mercury products legislation to rid the marketplace of 

mercury-containing items. 

14 states have passed legislation to eliminate lead in certain products. 

12 states have adopted laws to replace PBDEs with safer alternatives. 

Washington State is implementing a comprehensive plan and regulations to target 

PBTs for reduction and phase out. 

Internationally, the Stockholm Convention on Persistent Organic Pollutants 

(POPs) and the Protocol on Persistent Organic Pollutants to the Convention on 

Long-Range Transboundary Air Pollution (LRTAP) have targeted numerous 

PBTs for global phase-outs. 

Companics that make or use PBTs are also acting to reduce or eliminate them: 

Based on the toxicity of per flu oro octanoic acid (PFOA) and related chemicals, 

and growing evidence they are accumulating in the blood of the U.S. population, 

EPA negotiated an agreement with DuPont and other producers of these 

chemicals to phase out their use by 2015. 

SC Johnson has adopted a company policy under which it prohibits use ofPBTs 

in its products. 

Consumer electronics companies such as Apple and Sony Ericsson are on traek to 

eliminate all halogenated substances, including PVC and all brominated and 

chlorinated flame retardants, from their produets. 

We cannot wait for continued delay and endless study while these chemicals continue to 

build up in people and the environment. We urge you to follow the lead of the many U.S. 

states, nations and companies that are meeting the challenge of eliminating all but 

essential uses of PBTs. 
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Thank you for your attention to this important issue. We look forward to working with 

you toward meaningful TSCA reform that better protects our health and environment. 

Sincerely, 

Alaska: 

Pamela Miller, Executive Director 

Alaska Community Action on Toxies 

Anchorage. AK 

Kenneth Kingeekuk, President 

Tribal Council 

Native Village of Savoonga, St. Lawrence Island, Alaska 

Andrea Carmen, Executive Director 

International Indian Treaty Council 

Palmer. AK 

California: 

Ansje Miller, Coordinator 

Californians for a Green and Healthy Economy 

Oakland, CA 

Eveline Shen, Executive Director 

Asian Communities for Reproductive Justice 

Oakland, CA 

Gretchen Lee, Policy Director 

Breast Cancer Fund 

San Francisco, CA 

Joseph H. Guth, J.D .. Ph.D .. Legal Director 

Science & Environmental Health Network 

Albany,CA 

Jose T. Bravo, Director 

Just Transition Alliance 

San Diego, CA 

David W. Campbell, Secretary-Treasurer 

United Steelworkers Local 675 

Carson,CA 

Pamela King Palitz, Environmental Health Advocate and Staff Attorney 

Environment California 

Los Angeles, CA 
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Wafaa Aborashed, Executive Director 

Bay Area Healthy 

Davis Street Family Resource Center 

San Leandro, CA 

Kristin S. Schafer. Senior Policy Analyst 

Pesticide Action Network 

San Francisco, CA 

Michael Green, Executive Director 

Center for Environmental Health 

Oakland,CA 

Connecticut: 

Cindy Luppi, New England Co-Director 

Clean Water Action 

Hartford. CT 

Sarah UhL Environmental Health Coordinator 

Coalition for a Safe & Healthy Connecticut 

Hartford, CT 

Carole Bergeron, PhD, Executive director 

CT Nurses' Association and CT Nurses' Foundation 

Meriden. CT 

Carolyn Wysocki 

Ecological Health Organization (ECHO) 

Berlin, CT 

Mark MitchelL Executive Director 

Connecticut Coalition for Environmental Justice 

Hartford, CT 

Phil Sherwood. Deputy Director 

Connecticut Citizen Action Group 

Hartford, CT 

Jenn Hatch. Program Associate 

Connecticut Public Interest Research Group 

West Hartford, CT 

Michael Fitts, Executive Director 

ConnectiCOSH 

Newington, CT 
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Rabbi Andrea Cohen-Kiener 

Executive Director. Connecticut Interreligious Eco-Justice Network. 

Hartford, CT 

Megan Jenny, Connecticut Community Organizer 

Toxics Action Center 

West Hartford. CT 

Diane Ethier. President 

Connecticut Foundation for Environmentally Safe Schools 

CT 

District of Columbia: 

Andy Igrejas, Campaign Director 

Safer Chemicals, Healthy Families 

Daniel Rosenberg. Senior Attorney 

National Resources Defense Council 

Washington, DC 

Kirsten Moore. President & CEO 

Reproductive Health Te~hnologies Project 

Washington. DC 

Richard A. Denison. PhD., Senior Scientist 

Environmental Defense Fund 

Washington. DC 

Rose Gonzalez, MPS, RN. Director. Government Affairs 

American Nurses Association 

Washington, DC 

Joan Blades, President 

Moms Rising 

Washington. DC 

Daryl Ditz, Senior Policy Advisor 

Center for International Environmental Law 

Washington, DC 

Jeff Sell, Esq., Advocacy and Public Policy VP 

Autism Society 

Washington, DC 

Lynn Thorp. National Campaigns Coordinator 

Clean Water Action 

Washington, DC 
99 


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Liz Hitchcock. Public Health Advocate 

U.S. PIRG 

Washington. DC 

Ed Hopkins. Director - Environmental Quality Program 

Sierra Club 

Washington. DC 

Joyce Martin. Director. Environmental 

Health Policy 

American Association on Intellectual and Dcvelopmental 

Disabilities (AAIDD) 

Washington. DC 

Emily Enderle. Legislative Associate 

Earth Justice 

Washington. DC 

Wayne Shields. CEO & President 

Association of Reproductive Health Professionals (ARHP) 

Washington. DC 

Kristen Welker-Hood. ScD MSN RN. Director. Environment and Health Programs 

Physicians for Social Responsibility 

Washington. DC 

Anna Gilmore Hall, RN. CAE, Executive Director 

Health Carc Without Harm 

Washington. DC 

H1inois: 

Max Muller, Program Director 

Environment Illinois 

Chicago.IL 

Brian Imus. Director 

Illinois PIRG 

Chicago.IL 

Indiana: 

Lin Kaatz Chary. PhD. MPH 

Indiana Toxies Action 

Gary. IN 

Georgia: 

Daniel Parshley. Project Manager 

Glynn Environmental Coalition 

Brunswick. GA 
100 


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Kentucky: 

Joetta Venneman, Director of the Office of Global Ministries 

Sisters of Charity of Nazareth Congregational Leadership 

Nazareth, KY 

Elizabeth Crowe, Director 

Kentucky Environmental Foundation 

Berea, KY 

Massachusetts: 

Bill Ravanesi MA, MPH. Boston Regional Director 

Health Care Without Harm-Boston 

Longmeadow, MA 

David Ozonoff. MD, MPH. Professor of Environmental Health 

Boston University School of Public Health 

Boston.MA 

Susie Davidson. Co-Coordinator 

Coalition on the Environment and Jewish Life, Boston Chapter 

Brookline, MA 

Lee Ketelsen. New England Co-Director 

Clean Water Action 

Boston. MA 

Janet S. Domenitz. Executive Director 

MASSPIRG 

Boston.MA 

Joan Kulash. President 

People for the Environment 

North Andover. MA 

Ellie Goldberg, M.Ed .. VP Legislation 

Massachusetts Parent Teacher Association (Mass PTA) 

Rehoboth. MA 

Margo Simon Golden, President Board of Directors 

Women's Community Cancer Project 

Cambridge, MA 

Debra Fastino. Director 

Coalition for Social Justice 

Fall River, MA 
101 


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Gary Cohen, President 

Environmental Health Fund 

Boston, MA 

Deborah E, Moore, PhD, Executive Director 

Second Look 

Worcester, MA 

Maryland: 

Jenny Levin, Associate 

Maryland Publk Interest Research Group 

Baltimore MD 

Nanette Schweitzer, President 

Learning Disabilities Association of Maryland 

Dunkirk,MD 

Lorne K. Garrettson, MD, FAAP, FAACT., Prof Emeritus, Pediatrics and Environmental 

and Occupational Medicine. Emroy University. 

Sandy Spring. MD 

Cindy Schwartz, Executive Director 

Maryland League of Conservation Voters 

Annapolis, MD 

Tommy Landers, Policy Advocate 

Environment Maryland 

Baltimore, MD 

Maine: 

Christopher S1. John. Executive Director 

Maine Center for Economic Policy 

Augusta, ME 

Mike Belliveau. Executive Director 

Environmental Health Strategy Center 

Bangor, ME 

Meredith Small, Executive Director 

Toxics Action Center Campaigns 

Portland. ME 

Amanda Sears. Chair 

Alliance for a Clean and Healthy Maine 

Portland, ME 

Marc R. Mutty, Director of Office of Public Affairs 

Roman Catholic Diocese 
102 


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Portland, ME 

Staci K. Converse, Esq., Staff Attorney 

Disability Rights Center 

Augusta. ME 

Paul Santomenna. Executive Director 

Maine Chapter - Physicians for Social Responsibility 

Portland, ME 

Jesse Graham, Executive Director 

Maine People's Alliance 

Bangor. ME 

Ben Dudley, Executive Director 

Engage Maine 

Portland, ME 

Ruth Lockhart, Executive Director 

Mabel Wadsworth Women's Health Center 

Bangor, ME 

Mary Orear, Executive Director 

Mainely Girls 

Rockport, ME 

Gail Yolk, President 

National Council of Jewish Women Southern Maine 

Portland, ME 

Anne Conners, Chair 

Maine Women's Health Campaign 

Cushing, ME 

Will Everitt. Maine State Director 

League of Young Voters 

Portland, ME 

Brownie Carson. Executive Director 

Natural Resources Council of Maine 

Augusta, ME 

Sarah Standiford. Executive Director 

Maine Women's Lobby 

Hallowell, ME 

Dean Crocker, President and CEO 

Maine Children's Alliance 
103 


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Augusta, ME 

Russell Libby. Executive Director 

Maine Organic Farmers and Gardeners Association 

Unity, ME 

Peter Crockett. Executive Director 

Maine Labor Group on Health 

Augusta, ME 

David J. Mokler. PhD, Chapter Chair 

Sierra Club Maine Chapter, Chapter Chair 

Portland, ME 

Gene Kucinkas. Board President 

Learning Disabilities Association of Maine 

Oakland. ME 

Niaz Dorry. Coordinating Director 

Northwest Atlantic Marine Alliance 

Windham. ME 

Jill Conover. Executive Director 

Autism Society of Maine 

Winthrop, ME 

Carol Tiernan. G .E.A.R. Program Director 

G.E.A.R. Parent Network 

Augusta. ME 

Julia J. Bell, Executive Director 

Maine Developmental Disabilities Council 

Augusta, ME 

Beverly Baker 

Maine Parent Federation. Inc. 

Augusta. ME 

Chris Quint. Senior Public Affairs Director 

Planned Parenthood of Northern New England and Planned Parenthood of Northern New 

England Action Fund 

Portland, ME 

Virginia Mott. Legislative Chairperson 

Maine Parent Teacher Association 

Lakeville. ME 
104 


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Heidi Shott, Canon for Communications and Social Justice 

Episcopal Diocese of Maine 

Portland, ME 

Landis Hudson, Executive Director 

Maine Rivers 

Yarmouth, ME 

Rev. Jill Job Saxby, Executive Director 

Maine Council of Churchcs 

Portland, ME 

Michigan: 

Mike Garfield, Director 

Ecology Center 

Ann Arbor, MI 

Patricia Gillis, Executive Director 

Voices for Earth Justice 

Southfield. MI 

Sarah Mullkoff. Michigan Campaigns Coordinator 

Clean Water Action 

Lansing, MI 

Jackic D. Igafo-Te'o, Community Liaison 

Learning Disabilities Association of Michigan's Healthy Children Project 

Lansing, Michigan 

Lisa Wozniak, Executive Director. 

Michigan League of Conservation Voters 

Ann Arbor, MI 

Robin Heller, Executive Director 

LocalMotionGreen 

Grosse Pointe, MI 

Minnesota: 

Tim Stanley, Senior Director, Government and Public Affairs 

Planned Parenthood Minnesota, North Dakota. South Dakota 

Minneapolis, MN 

Lisa Wolf, Conference Coordinator 

Minnesota Association for Children's Mental Health (MACMH) 

St. Paul, MN 

Joshua Winters, Executive Director 

Minnesota Public Interest Research Group 
105 


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Minneapolis, MN 

Kathleen Schuler. Senior Policy Analyst 

Institute for Agriculture and Trade Policy 

Minneapolis, MN 

Peter Starzynski. Healthy Legacy Coalition Coordinator 

Healthy Legacy Coalition 

Minneapolis, MN 

Deborah Torraine, Secretary, Board Officer 

AfroEco 

St. Paul, MN 

Tessa HilL President 

Kids for Saving Earth 

North Branch, MN 

Cindy McComas, Program Director 

Minnesota Technical Assistance Program 

Minneapolis, MN 

Rebecca Sheets, Board President 

MnPA (Minnesota Pesticide Awareness) 

Staples, MN 

Susan Hubbard, Executive Director 

EUREKA Recycling 

Minneapolis, MN 

Montana: 

Erin Switalski, Executive Director 

Women's Voices for the Earth 

Missoula, MT 

Terry Kendrick 

Montana Women Vote 

Missoula, MT 

Allyson Hagen, Executive Director 

NARAL Pro-Choice Montana 

Helena, MT 

Stacy Anderson, Director of Public Affairs 

Planned Parenthood-Montana 

Helena, MT 
106 


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Kim Abbott 

Montana Human Rights Network 

Helena, MT 

Bonnie Buckingham, Executive Director 

Women's Opportunity and Resources Development-Montana 

Missoula, MT 

Cindy Weese, Executive Director 

YWCA-Montana 

Missoula, MT 

Andrea Davis, Executive Director 

home Word-Montana 

Missoula, MT 

Karen Knudsen, Executive Director 

Clark Fork Coalition 

Missoula, MT 

Jonda Crosby, Executive Director 

Alternative Energy Resource Organization-Montana 

Helena, MT 

North Carolina: 

Nicole Stewart, Organizer 

NC Conservation Network 

Raleigh, NC 

Ana Duncan Pardo, Communications Coordinator 

Toxic Free North Carolina 

Raleigh, NC 

New York: 

Kathleen A. Curtis, LPN, Policy Director 

Clean New York 

Schenectady, NY 

Cecil Corbin-Mark, Co-Coordinator 

JustGreen Partnership 

New York, NY 

Karen Miller. Executive Director 

Huntington Breast Cancer Action Coalition & Prevention is the Cure 

Huntington, NY 

Barbara J. Warren 

Citizens' Environmental Coalition 
107 


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Albany, NY 

David O. Carpenter, M.D., Director 

Institute for Health and the Environment 

University at Albany 

Rensselaer. NY 

Cynthia Wilson, Environmental Action Coordinator 

Citizens for a Clean Environment, Inc. 

CobleskilL NY 

Laura Weinberg, President 

Great Neck Breast Cancer Coalition 

Great Neck, NY 

Pamela LaBrake. Founder 

Parents Against Lindane 

Schenectady. NY 

Judy Braiman. President 

Empire State Consumer Project 

Rochester. NY 

Judith M. Anderson, President 

Environmental Justice Group ofWNY, Inc. 

Buffalo. NY 

Patricia Foucht 

Breast Cancer Coalition of Rochester 

Rochester. NY 

Marian Feinberg. Environmental Health Coordinator 

For A Better Bronx 

Bronx, NY 

Orgcon: 

Rcnce Hackenmillcr-Paradis. Program Director 

Orcgon Environmental Council 

Portland. OR 

Sarah Doll. National Coordinator 

Safcr States 

Portland. OR 

Oregon Center for Environmental Health 

Portland. OR 
108 


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Lisa Arkin. Executive Director 

Oregon Taxies Alliance. 

Eugene, OR 

Pennsylvania: 

Connie Parr, President 

Learning Disabilities Association of America 

Pittsburgh, PA 

Texas: 

Matthew S. Tejada, PhD, Executive Director 

Galveston-Houston Association for Smog Prevention and Mothers for Clean Air 

Houston. TX 

Virginia: 

Lois Gibbs, Executive Director 

Center for Health, Environment & Justice (CHEJ) 

Falls Church. VA 

Vermont: 

Charity Carbine. 

Alliance for a Clean and Healthy Vermont 

Burlington, VT 

Paul Burns. Executive Director 

Vermont Public Interest Research Group 

Montpelier. VT 

Carol Westinghouse 

Informed Green Solutions, Inc. 

East Burke, VT 

Washington: 

Laurie Valeriano. Policy Director 

Toxic Free Legacy 

Seattle. WA 

Ivy Sager-Rosenthal. Environmental Health Advocate 

Washington Toxics Coalition 

Seattle. WA 

Karen Bowman. Environmental Health Nurse Specialist 

Washington State Nurses Association 

Seattle. WA 

Mo McBroom. Policy Director 

Washington Environmental Council 

Seattle, WA 
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Elaine Rose. CEO 

Planned Parenthood VOTES' Washington 

Seattle. WA 

Clifford Traisman. Exeeutive Director 

Washington Conservation Voters 

Seattle. WA 

Lee Anne Beres. Executive Director 

Earth MinistryIWashington Interfaith Power & Light 

Seattle, WA 

Ann Clifton, Co-Chair 

Mercury Awareness Team of Washington 

Olympia, WA 

Elaine Rose. CEO 

Planned Parenthood VOTES! Washington 

Seattle. WA 

Blair Anundson. Consumer and Democracy Advocate 

WashPIRG 

Seattle. WA 

Mike Peterson. Executive Director 

The Lands Council 

Spokane. WA 

Darlene Schanfald, Project Coordinator 

Rayonier Hazardous Waste Cleanup Projeet 

Olympic Environmental Council Coalition 

Sequim WA 

Wisconsin: 

Connie Minowa. Co-Founder 

Earthology Institute 

Viroqua. WI 
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eNVIRONMENTAL WORKING GROUP wwwewg org 

March 3, 2010 

The Honorable Bobby l. Rush 

Chairman, Subcommittee on Commerce, Trade and Consumer Protection 

United States House of Representatives 

Washington, DC 20515 

Subject: Industrial chemicals in umbilical cord blood - including persistent and 

bioaccumulative compounds - need urgent action 

Dear Chairman Rush, 

Thank you for holding this hearing, "TSCA (Toxic Substances Control Act) and Persistent, 

8ioaccumulative, and Toxic Chemicals: Examining Domestic and International Actions," and for 

your continued leadership on reforming the outdated, broken Toxic Substances Control Act. 

Among the most notorious and dangerous chemicals ever put into commerce are so-called 

persistent bioaccumulative and toxic chemicals (PBTs). This category of pollutants includes 

DDT, polychorinated biphenyls (PCBs), the Teflon chemicals perfluorooctanyl sulfonate (PFOS) 

and perfluorooctanoic acid (PFOA), brominated flame retardants, lead and mercury compounds 

and dioxins. 

PBTs have been a priority for the environmental community and the Environmental Protection 

Agency (EPA) for the past 40 years. In fact, a rare and notable success under the current Toxic 

Substances Control Act (TSCA) has been EPA's program to keep new PBTs off the market 

through the Pre-manufacture Notification process. 

Environmental Working Group (EWG) has long been deeply concerned about PBTs. Our work 

over the past decade has been instrumental in achieving phase-out agreements for the 

persistent and bioaccumulative Teflon chemical, PFOA, and the brominated flame retardants, 

penta, otca and decabromodiphenyl ether (DecaBOE). EWG strongly supports rigorous controls 

and bans for existing high-risk PSTs and a policy that keeps new PSTs from entering the 

market. 

But PSTs are just one of several categories of chemicals that demand priority action under a 

reformed national toxic chemicals policy. The broader and more fundamental question before 

Congress is how to set priorities in a new federal toxic substances law that will deal effectively 

with the tens of thousands of chemicals used in consumer products and the many hundreds of 

these already known to contaminate the human body. 

Curbing environmental pollution and human exposure to PSTs must be a priority for reform. 

But elevating PSTs as a class to a super-priority status could delay progress towards muchneeded protections from other substances that pose a threat to Americans as great or even 

greater than that from many PSTs. 

HEADQUARTERS 1436 U st. NW, SUite 100 Washington, DC 20009 I P: 202.667.6982 F: 202.232.2592 

CALIFORNIA OFFICE 2201 Broadway, Suite J08 Oakland, CA 94612 I P: 510.'144.0973 F: 510.444.0982 

MIDWEST OFFICE lOJ E. 6th Street, SUite 201 Ames, IA 50010 I P: 515.598.2221 
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The Honorable Bobby L. Rush 

[ndustriai Chemicals in Umbilical Cord Blood - Including PBTs Need Urgent Action 

Children's health must be the top priority 

March 3. 2010 

Page 2 

The chemicals that deserve highest priority are those that contaminate the blood of babies 

before they are born. There is an emerging consensus within scientific and medical 

communities that the most critical chemical exposures occur before birth, when the brain and 

other organs are exquisitely sensitive to trace changes in blood chemistry. Any substance, PBT 

or otherwise, that intrudes upon the womb and threatens a child's normal development must 

receive our most urgent attention. 

EWG has detected nearly 300 chemicals in the cord blood of 20 American newborns. Many of 

these chemicals are PBTs. But others are not. Among the most troubling substances found in 

cord blood that are not PBTs are bisphenol A, the synthetic estrogen and plastics component; 

perchlorate, a thyroid toxin and explosives chemical used in fireworks, airbags and rocket fuel; 

and phthalates, a class of potent endocrine disruptors linked to birth defects in boys and a 

common component of soft plastics. 

In our view, a chemical's persistence in the environment or its ability to accumulate in living 

things should render it of very high regulatory concern. But those two criteria should not be 

the only factors that elevate a chemical to top priority for regulatory action. The test must be 

the toxicity, including the endocrine-disrupting properties of each substance, and the 

intensity of exposure faced by high-risk populations such as pregnant women, their fetuses 

and newborns. 

States move to protect children 

The absence of a strong federal chemicals policy has led to numerous state initiatives aiming 

to protect the public. particularly children, from high-risk chemical exposures. Few national 

organizations have worked harder than EWG to support states' efforts to ban or restrict the 

chemicals of highest concern in consumer products, where such actions were merited. 

EWG's research has helped drive and sustain these efforts, including our 12 studies measuring 

chemical pollution in 200 people and our analyses of human health risks from exposures to 

common, toxic consumer product chemicals. EWG experts have testified in support of single 

chemical bans and broader chemical policy reform legislation in nine states: California, Illinois, 

Iowa, Maine, Maryland, Massachusetts, Minnesota, Oregon and Pennsylvania, plus the District 

of Columbia. In California, EWG was the lead sponsor of legislation in 2008 and 2009 to ban 

BPA in baby bottles and children's cups. 

States have helped pave the way to federal policy reform, but state efforts have not been 

targeted exclusively or even primarily toward PBTs. Instead, state lawmakers have focused on 

chemicals that present the greatest risks to children. 

In 2009 and 2010, legislation was introduced in 21 states and the District of Columbia to ban 

BPA (not a PBT) in baby bottles and other children's products. BPA bans have been signed into 

law two states Minnesota and Connecticut - and are awaiting gubernatorial signatures in 

three states - Maryland, Washington, and Wisconsin. At the same time at least three states -

Oregon, Washington and Maine - have enacted laws to ban high-risk uses of Deca BDE, a PBT 

flame retardant. Similar Deca ban bills are pending in 12 more states and the District of 

Columbia. 
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The Honorable Bobby l, Rush 

Industrial Chemicals in Umbilical Cord Blood - Including PBIs - Need Urgent Action 

Mnrch 3, 2010 

Page 3 

Maine and Washington have passed broader legislation designed to protect children from highhazard chemicals in toys and other products intended for children. One of several criteria for 

targeting chemicals under these laws is whether or not a chemical is a PBT. Washington also 

has a program to list PBTs and publish action plans to reduce their use and promote 

alternatives, Initiated in 2000 by the Department of Ecology, the program has listed 27 PBTs 

to date and has published action plans for three. 

No state has passed legislation banning all PBTs as a group, and no state has passed 

legislation that singles out PBTs as a higher-priority group of chemicals than those with other 

hazardous characteristics, such as their ability to cause cancer. The Maine Toxic Chemicals in 

Children's Products Act, for example, designates a chemical's ability to cause cancer, 

reproductive or developmental harm, or to disrupt the endocrine system along with persistence 

and bioaccumulation as criteria for being listed as a chemical of high concern (Maine Revised 

Statutes, Title 38, Chapter 16-0, Sec 1693), All the criteria are equally important under the 

law, 

Congressional action is needed 

This steady stream of state bills reflects strong, broad-based support for chemical policy reform 

at the national leveL Comprehensive federal reform, like that proposed in the Kid-Safe 

Chemicals Act of 2008, would protect the health of all Americans, not just those living in a 

short list of states currently advancing reforms one chemical at a time. 

Only action at the federal level can tackle the sheer number of PBTs in use today. Academic 

studies estimate that as much as three percent of all chemicals are persistent and 

bioaccumulative (Howard et al 2010). EPA lists about 140 chemicals as PBTs, among them are 

lead, mercury and cadmium, 

PBTs permeate the economy and reigning them in is an extremely complex task that only the 

federal government can perform, Of the hundreds of PBTs in use today, some likely present 

serious health threats. Others probably do not. The absence of state initiatives banning PBTs 

is in part due to recognition of this fact, and in part due to the fact that some persistent and 

bioaccumulative compounds are used in important products where a ban is currently difficult 

to justify. Mercury is used in all energy-saving compact fluorescent light bulbs, PFOS is critical 

for airplane brakes, and lead is fabricated into a wide range of products from car batteries to 

crystal chandeliers, Although PBTs share characteristics that make them uniquely problematic, 

it is critical that actions to reduce and eliminate them, first target high-risk uses. 

The American people need and deserve a toxic chemicals policy that sets clear and defensible 

priorities and targets all the high-risk chemicals on the market, not just those with certain 

characteristics. 

The Kid-Safe Chemicals Act introduced in earlier sessions of Congress proposed comprehensive, 

yet practicable and effective remedies that would give high priority to PBTs. We strongly 

support those provisions and believe they could be strengthened to require that any persistent 

and bioaccumulative chemical be presumed unsafe, Industry would then have one year to rebut 

that presumption and prove that the chemical meets the safety standard of the law, or it 

would be taken off the market. This would place PBTs on par with provisions in the bill 

governing all chemicals found in cord blood, which would also be presumed unsafe until 
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The Honorable Bobby l.. Rush 

Industrial Chemicals in Umbilical Cord Blood - Including PBTs Need Urgent Action 

,'larch 3, 2010 

Page 4 

proved otherwise. But it would not grant PBTs elevated status, and it would apply consistent 

criteria to both priority groups. 

We applaud you for holding this hearing, and we thank you for your leadership in efforts to 

reform the Toxic Substances Control Act. We look forward to the introduction of your 

legislation and working with you to ensure its passage. 

Sincerely, 

Richard Wiles 

Senior Vice-President, Policy & Communications 

\ ' f : 

Jane Houlihan 

Senior Vice-President for Research 
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Earth Ministry- Ecumenical Ministry of Oregon's Interfaith Network for Earth ConcernsThe Episcopal Church- Evangelical Lutheran Church in America- Friends Committee on 

National Legislation- GreenFaith- Interreligious Eco-Justice Network- Presbyterian Church 

(U.S.A.) Washington Office- Maine Council of Churches- Maryknoll Office of Global 

Concerns- Massachusetts Council of Churches- Minnesota Council of ChurchesMissionary Oblates, Justice, Peace/lntegrity of Creation Office- National Council of 

Churches- Pennsylvania Council of Churches- United Church of Christ, Justice and 

Witness Ministries- The United Methodist Church - General Board of Church and SocietyThe United Methodist Women- Unitarian Universalist AssociationUnitarian Universalist Ministry for the Earth- Texas Impact- Voices for Earth Justice 

Honorable Bobby L. Rush, Chairman 

Subcommittee on Commerce, Trade and Consumer Protection 

Committee on Energy and Commerce, U.S. House of Representatives 

2125 Rayburn House Office Building, Washington, D.C. 20515 

CC: Chairman Henry Waxman 

Chairman Frank Lautenberg 

Senator James Inhofe 

Chairwoman Barbara Boxer 

Administrator Lisa Jackson 

March 2, 2010 

Dear Chairman Rush, Ranking member Radanovich, and Members of the Subcommittee, 

As various faith traditions, we are united across theological lines on the need to protect Creation, 

care for our bodies, and care for vulnerable populations. We believe that all humankind is created 

in God's image and receives nourishment from the bounty of God's Creation (Genesis 1 :26-27). 

Caring for our own bodies is an essential aspect of our cal! to care for and honor God's Creation 

(I Corinthians 6:19; Genesis 2:15). Unfortunately, current chemical policies are failing to protect 

us. Scientists are finding strong links between serious health concerns and the chemicals we are 

exposed to in the air we breathe, the food we eat, the water we drink, and the products we use. 

We applaud you for hosting a hearing concerning Persistent, Bioaccumulative, and Toxic 

chemicals (PBTs), a particularly dangerous class of chemicals. These chemicals can last for long 

periods of time, travel long distances, accumulate in organisms, become more potent as they 

move up the food chain, and they are highly toxic. Swiftly phasing out PBTs should be a key 

component of comprehensive chemical policy reform. 

These chemicals threaten the integrity of God's good Creation, the health of communities in the 

United States, and our sisters and brothers across the globe. They can even be passed on to 

future generations through the developing fetus and through the breast milk of nursing mothers. 

Native communities and other members of Creation in the Arctic are especially vulnerable 

because PBTs naturally migrate and accumulate at the poles. Low-income communities and 

communities of color living near incinerators and other sites where PBTs are present are also 

highly vulnerable. These chemicals are linked to health conditions including cancer, learning and 

developmental disabilities, early onset puberty, and infertility. 

Over the last ten years, many denominations and faith traditions have passed policies to raise 

awareness in their congregations and have taken bold action to curtail use of specific PBTs such 

as dioxin, mercury, and lead. We are also concerned about newer classes of PBTs such as 

polybrominated diphenyl ethers (PBDEs) widely used as flame retardants, and perf!ourinated 

compounds (PFCs) such as those used in paper packaging, stain resistant materials, or non-stick 

cookware. Our communities are responding in faith by making changes in the products used in 
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homes and congregations, and by advocating on a state level for laws that ensure God's Creation 

and vulnerable populations are protected from the most dangerous toxic chemicals. 

However, individual actions and state laws are only one part of the solution. We need a 

more comprehensive approach. It is time for the federal government to act and repair chemical 

legislation that is failing to protect the U.S. population and communities across the globe. The 

evidence is mounting that toxic chemicals are threatening the health of God's Creation and all of 

God's children. The United States Government has a moral responsibility to protect Creation, and 

the citizens in this country and around the world. 

As you work to modernize the Toxic Substances Control Act, we urge you to consider 

immediate action to aqdress the most dangerous of chemicals to which people are being 

exposed. PBTs should be phased out, with exceptions only for critical uses where we lack 

a viable, safe alternative. 

We hope that we can work with you to reform national chemical laws to ensure the health of 

Creation, protect vulnerable populations, and enable future generations of God's children to live 

healthy lives. 

Sincerely, 

Earth Ministry (Washington State) 

Ecumenical Ministry of Oregon's Interfaith Network for Earth Concerns 

The Episcopal Church 

Evangelical lutheran Church in America 

Friends Committee on National legislation 

GreenFaith (New Jersey) 

Interreligious Eco-Justice Network (Connecticut) 

Pennsylvania Council of Churches 

Presbyterian Church (U.S.A.) Washington Office 

Maine Council of Churches 

Maryknoll Office of Global Concerns 

Massachusetts Council of Churches 

Minnesota Council of Churches 

Missionary Oblates, Justice, Peace/Integrity of Creation Office 

National Council of Churches 

United Church of Christ, Justice and Witness Ministries 

The United Methodist Church - General Board of Church and Society 

The United Methodist Women 

Unitarian Universalist Association 

Unitarian Universalist Ministry for the Earth 

Texas Impact 

Voices for Earth Justice (Michigan) 

Contact information: 

Chloe Schwabe 

Environmental Health Program Manager 

National Council of Churches 

202-481-6932 

chloe@nccecojustice.org 
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PesticideAdion 

Network 

March 3. 2010 

Honorable Bobby L Rush. Chairman 

Subcommittee on Commerce. Trade and Consumer Protection 

Committee on Energy and Commerce. U.S. House of Representatives 

2125 Rayburn House Office Building 

Washington. D.C 20515 

Honorable Ed Whitfield. Ranking Member 

Subcommittee on Commerce. Trade and Consumer Protection 

Committee on Energy and Commerce. U.S. House of Representatives 

1411 Raybul11 House Office Building 

Washington. D.C 20515 

Dear Chairman Rush and Representative Whittield: 

Thank you for holding the upcoming hearing on the important issue of persistent 

bioaccumulative toxic chemicals (PBTs). 

Enclosed please find a petition from 2.597 of our supporters who are very 

concerned about the health and environmental impacts of PBTs. and are urging 

Congress to prioritize action on these dangerous substances. The list represents 

citizens from 48 states and the District of Colombia. with the most signiticant 

numbers from California. New York, Florida. Texas. Illinois. Massachusetts and 

Pennsylvania. 

Pesticide Action Network (p AN) North America is one of live independent 

regional centers of PA'N International. a worldwide network of more than 600 

organizations in 90 countries. 

Sincerely, 

Kristin S. Schafer 

Senior Policy Analyst 

PAN North America 

Kristins/£:i'.panna.org 

Advancing Alternatives to Pesticides Worldwide 

49 Powell St, Suite 500, San Francisco, CA 94102·415.981.1771· www.panna.org 

N 

IN-rug,. liN@' 
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March 3, 20 I 0 

Honorable Bobby L. Rush, Chairman 

Subcommittee on Commercc. Trade and Consumer Protection 

Committee on Energy and Commerce, U.S. Housc of Representatives 

2125 Rayburn House Office Building, Washington. D.C. 20515 

Honorable Ed Whitfield. Ranking Member 

Subcommittee on Commerce, Trade and Consumer Protection 

Committee on Energy and Commerce, U.S. lIouse of Representatives 

2411 Rayburn House Office Building. Washington. D.C. 20515 

Dear Chairman Rush and Representative Whitfield: 

Thank you for holding a hearing on the important topic of "Persistent 

Bioaccumulativc Toxic (PBT) Chemicals." We are writing to express our concern 

about these chemicals, and our strong support for prioritizing action on PBTs in any 

efforts moving forward to reform the Toxic Substanccs Control Act (TSC A). 

PBTs are inherently unsafe. They persist in the environmcnt for many years often 

decades. They build up in the food chain, and can pass from mother to child during 

pregnancy. And they are highly toxic, allen at very low levels of exposure. Because 

ofthe persistence of these chemicals, low but sustained emissions of PSTs willlcad 

to dangerous levels over time. Many health effects trom low-level exposure arc long 

term, sometimes even appearing in the next generation. Both of these properties 

making traditional risk assessment an ineffective tool for determining and reducing 

the dangers these chemicals pose. 

Some PBTs can also travel across borders, accumulating in the Arctic region \vhere 

they threaten the health and livelihood of indigenous communities, by contaminating 

traditional foods and reaching astounding levels in the bodies of indigenous peoples. 

·~/e urge you and your colleagues to recognize the urgency of taking action on PBTs, 

as your international colleagues have done through the Stockholm Convention on 

Persistent Organic Pollutants. It's time to protect the communities of today and 1l.lIure 

generations of tomorrow from dangerous chemicals. Let's get our house in order on 

PSTs. 

Sincerely, 

2,597 concerned citizens from 48 states and the District of Colombia 
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MORGAN STATE 

~ UNIVERSITY. ,. '.~'~n. 

School of Community Health & Policy 

February 18,2010 

The Honorable Henry Waxman 

Chair, House Committee on Energy and Commerce 

2204 Rayburn House Office Building 

Washington, D.C. 20515 

Dear Representative Waxman, 

Thank you for taking a leading role in the current legislative etforts to strenb>then our 

national chemical policies. Your leadership on issues related to public health is 

recognized and appreciated in our community. As you know, the American Public Health 

Association (APHA) has for many years called for reform of the Toxic Substances 

Control Act to better protect the public from the health impacts oftoxic chemicals, and 

we are pleased that such efforts now appear to be moving forward. 

I am writing now to encourage you to prioritize efforts to effectively protect the public 

from the dangers of persistent, bio-accumulative toxins (PBTs). This group of chemicals 

poses a particular set of challenges and risks, including health threats from very low 

levels of exposure and intergenerational effects. I hopc that any effort to strengthen our 

system of addressing national chemicals will include the provision of tools to our 

regulatory agencies to take rapid action on PBTs. As outlined in APHA Policy #20055 

(Dec 2005), PBTs are viewed as an urgent priority among public health professionals. 

In addition to supporting reform ofTSCA (see APHA Policy 20077; Nov, 2007), the 

Association has also for many years supported international eftorts to address persistent 

organic pollutants (POPS), as outlined in APHA Policy #20009 (Jan, 2000). Inclusion of 

strong authority to address PBTs at home will enable the U.S. to provide leadership on 

POPs at the international level through the Stockholm Convention. 
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Please feel free to contact me should you have any questions or need more information 

on APHA's position on PBTs and the current TSCA reform efforts. 

Sincerely, 

Andrea Kidd Taylor, DrPH, MSPH 

Member, APHA Executive Board 

Assistant Pro fessor 

Morgan State University 

School of Community Health & Policy 

References: APHA Policy #20055: Protecting Human Milk from Persistent Chemical 

Contaminants 

http://www.apha.orgladvocacy/policy/policysearch/default.htm?id= 13 21 

APHA Policy #20077: Calling on the US Congress to Restructure the 

Toxic Substances Control Act of 1976 

http://www.apha.orgladvocacy/policy/policysearch!default.htm 'Jid= 1350 

APHA Policy # 20009: Support for International Action To Eliminate 

Persistent Organic Pollutants 

http://www.apha.orgladvocacy/policy/policysearch/default.htm?id= 214 

2 
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The Honorable Bobby L. Rush 

merican' Chemistry Council 

March 3, 2010 

Chairman, Subcommittee on Commerce, Trade and Consumer Protection 

United States House of Representatives 

Washington, D.C. 20515 

The Honorable Ed Whitfield 

Ranking Member, Subcommittee on Commerce, Trade and Consumer Protection 

United States House of Representatives 

Washington, D.C. 20515 

Dear Chairman Rush and Ranking Member Whitfield: 

The House Subcommittee on Commerce, Trade and Consumer Protection is scheduled to hear testimony 

March 4th from several witnesses concerning persistent, bioaccumulative and toxic (PBT) substances, and 

their regulation under U.S. and international law. The American Chemistry Council (ACC), a national 

trade association representing 140 member companies that employ 800,000 workers, requests that ACe's 

perspectives on this issue be entered into the hearing record. 

As I testified before tbe Subcommittee last year, ACC and its members welcome Congress' review of the 

Toxic Substances Control Act (TSCA) and tbe measures that might be taken to modernize the statute. 

ACC sbares tbe objective of protecting human health and the environment from any significant risks 

associated with chemicals with PBT properties. It is important that any modifications to TSCA take into 

account the significant advances in PBT regulation already achieved under both domestic and 

international law. 

PBT substances represent a very small percentage of chemicals in commerce in the U niled States. I Many 

are eitber strictly regulated, are not currently in production, or are tbe by-products of human and natural 

activity. PBTs encompass a range of substances, including some metals and a variety of organic 

compounds. 

ACC and its members have long supported processes where PBT substances receive priority attention in 

risk characterization, risk management, and pollution prevention programs. ACC member companies 

have committed to a goa! of minimizing the potential human health and environmental risks that may be 

associated with PBTs. Through Responsible Carc® and similar initiatives, ACC members have worked 

to characterize their products and processes and take appropriate actions. Although not specific to 

1 A "PBT" is a chemical that persists (P) in the environment, has the potential to bioaccumulate (B) in the food 

chain to relatively high levels, and is toxic (T). Only those chemicals that exceed EPA criteria in all three categories 

- P, B, and T,- are considered potential PBTs. 

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The Honorable Bobby L. Rush 

The Honorable Ed Whitfield 

March 4, 20 I 0 

Page 2 

substances with PBT characteristics, to date over 1,000 product safety summaries have been produced by 

ACC member companies, and are publicly available through ACe's website. 2 

In September 1995, the Board of Directors of ACC (then the Chemical Manufacturers Association) 

approved a policy statement on PBTs that underscored ACe's commitment to reduce potential risks from 

PBT materials (i.e., products, byproducts and wastes that contain PBT substances). Simply stated, 

ACe's policy acknowledges the fundamental properties ofPBTs and affinns that substances identified 

through screening as possible PBTs deserve priority attention in further risk characterization. While 

screening is a critical step in the process in that it allows larger numbers of materials to be evaluated more 

rapidly and in a cost-effective manner, it is not by itself a sufficient basis for risk management. In 1996, 

ACC produced guidance material for its members to use in addressing PBT substances. 

In the sequence outlined in the ACC policy, the potential need for and fonn of risk management ofPBTs 

is detennined after a thorough risk characterization of candidate materials identified through screening. 

This process is consistent with the approach ACC has recommended for modifications to TSCA - a 

process in which a chemical substance's hazards, uses and exposures are screened and assessed, and 

appropriate regulatory and risk management decisions are based on an integrated evaluation of hazard, 

use and exposure infonnation, rather than just hazard information alone. 

It is important to note that the Environmental Protection Agency (EPA), and indeed the U.S. government 

as a whole, has provided significant leadership on PBT issues. In the late 1990's, EPA pursued a 

National PBT program, which included lower reporting thresholds for PBTs on the Toxics Release 

Inventory, and the development of a prioritization tool for waste streams containing PBTs. 

The signature element of the program, however, was a little-observed change in the Agency's policy for 

reviewing TSCA pre-manufacturing notices (PMNs) for substances that met PBT related criteria. The 

PBT PMN policy, adopted in 1999, was the first effort by any government to address new chemicals that 

exhibit PBT characteristics. EPA's policy sent a clear message to chemical manufacturers and importers 

that, absent extensive additional data on PBr substances (including use and exposure information), the 

Agency would generally reject PMN applications meeting the highest PBT category of concern. 

Although PBr substances have in general been a very small percentage of new chemical applications, the 

fact remains that the policy has been very effective in reducing the number of new PBr substances and in 

establishing appropriate risk management measures for those few that have entered the market. 

In addition, the U.s. government has long supported the negotiation and implementation of several 

international instruments designed to reduce the regional and global risks of a subcategory of PBT 

substances known as Persistent Organic Pollutants (POPs). The Stockholm Convention on POPs and the 

U.N. Economic Commission for Europe's Protocol on POPs reflect the international community's 

commitment to reduce, and where possible eliminate, the risks of certain listed POPs which meet 

established PBT criteria and are also known to undergo, respectively, global or regional environmental 

transport. Both instruments reflect the significant leadership of the U.S. government, particularly in the 

criteria for the identification of POPs substances. Both instruments adopt a science based approach to 

international POPs regnlation. 

2 ACe's search tool and portal to the safety summaries is available at http:: reporting.responsiblecareus.com/Searcll:PSSummarvSearch.asill!:. 

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The Honorable Bobby L. Rush 

The Honorable Ed Whitfield 

March 4, 2010 

Page 3 

ACC strongly supported the negotiation of the international POPs instruments, and has long advocated for 

U.S. Senate advice and consent to ratification and their reasonable implementation into U.S. law. (See 

Attachment A) Unfortunately, despite U.S. signature of both instruments, Conf,,>Tess has not approved the 

changes to TSCA and the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) necessary to 

implement these agreements in U.S. law. ACC believes that Congress should include appropriate 

implementing language as it considers modifications to TSCA so that the United States can become a full 

Party to these agreements. U.S. participation and leadership in the implementation of these agreements is 

crucial in maintaining the risk-hased, science-justified POPs identification and management effort they 

adopt. 

As Congress discusses modifications to TSCA, PBT substances appropriately warrant review and 

assessment. The recommendations ACC has made for prioritization screening and safety assessments, as 

reflected in our principles for TSCA modernization, provide a mechanism to address the special health 

and environmental concerns that may arise from these substances, and an appropriate process by which 

measures to manage their risks can be taken. (See Attachment B) 

In ACCs view, TSCA modifications should reflect the most up-to-date scientific thinking about how to 

evaluate PBTs and POPs. In 1997 and again in 2008 the Society for Environmental Toxicology and 

Chemistry (SETAC), sponsored workshops on PBT/POPs substances (aka "Pellston Workshop")'. The 

workshops helped advance the science of PBT characterization by reaching consensus on how to better 

identify PBTs and POPs at an early stage, using new scientific information and tools, rather than simply 

defaulting to criteria that have been in place since the late 19705. This workshop included leading 

scientists from academia, government, regulatory bodies and industry. Follow-up from the 2008 

workshop is underway. Congress should consider this scientific discussion on PBTs and POPs to assure 

that the most up to date, reliable scientific methods are applied. 

ACC and its members look forward to working with you and the Subcommittee members as discussions 

around modifications to TSCA continue. lfwe can provide any additional information on ACCs position 

on TSCA modernization, please contact me. 

Sincerely, 

Cal Dooley 

President and CEO 

cc: Subcommittee on Commerce, Trade and Consumer Protection 

3 The Executive Summary of the Proceedings of the Workshop are available at 

http:,'·wW\\i. '\ctac. or£!;' ~ite~:de fau It:' fi ie'S' E '(~cut i veSum mar". pdf 

americanchemistry, com" 1300 Wilson Boulevard. Arlington, VA 222091 (703)741.5000 
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Attachment A 

TESTIMONY OF THE 

AMERICAN CHEMISTRY COUNCIL 

BEFORE THE 

HOUSE SUBCOMMITTEE ON ENVIRONMENT AND HAZARDOUS MATERIALS 

ON LEGISLATION TO IMPLEMENT 

THE STOCKHOLM CONVENTION ON PERSISTENT ORGANIC POLLUTAl'lTS, THE 

LRTAP POPS PROTOCOL, AND THE ROTTERDAM CONVENTION ON 

PRIOR INFORMED CONSENT 

MARCH 2, 2006 

Michael P. Walls, Esq. 

American Chemistry Council 

\300 Wilson Boulevard 

Arlington, VA 22209 

(703) 741-5000 
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TESTIMONY OF THE 

AMERICAN CHEMISTRY COUNCIL 

ON LEGISLATION TO IMPLEMENT 

THE STOCKHOLM CONVENTION ON PERSISTENT ORGANIC POLLUTANTS, THE 

LRTAP POPS PROTOCOL, AND THE ROTTERDAM CONVENTION ON 

PRIOR INFOR.\J!ED CONSENT 

March 2, 2006 

I. Introduction 

The American Chemistry Council (ACC) appreciates this opportunity to reiterate its 

strong support for the three international agreements that arc the subject of this hearing: the 

Stockholm Convention on Persistent Organic Pollutants (POPs), the U.N. Economic 

Commission for Europe's POPs Protocol to the Convention on Long-Range Transboundary Air 

Pollution (LRTAP POPs Protocol) and the Rotterdam Convention on Prior Informed Consent 

(PIC). We also appreciate the opportunity to record our strong support for H.R. 4591, Mr. 

Gitlmor's legislation to implement these agreements by amending the Toxic Substances Control 

Act (TSCA). 

Prompt action on H.R. 4591 is required to ensure that the United States can continue its 

international leadership role under these agreements. H.R. 4591 contains the legislative changes 

to TSCA necessary for the United States to meet its obligations under these agreements, and it 

sends a powerful message to other governments - a message that the agreements must be 

implemented as they were intended, with no more and no less. 

II, U.S. Participation is Necessary in Order to Ensure the Reasonable Implementation 

of these Agreements. 

As the Subcommittee is aware, the LRTAP POPs Protocol, the Stockholm Convention 

and the PIC Convention are all in force. Initial meetings of the parties to these agreements have 

been held, key positions on subsidiary bodies have been allocated, and work has already begun in 

those subsidiary bodies. Chemicals of significant importance to U.S. industry have been 

nominated for inclusion in the conventions. Future decisions on nominated chemicals, review 

processes and best practices will have a major impact on our industry, which is global in scale. 

Already the risk-based, science-justified processes for listing new chemicals are under attack by 

governments who would prefer to ignore those requirements. Yet the ability of the United States 

to lead and appropriately influence the decisions that have long-term consequences for the 

operation of the agreements has been signiticantly reduced because our government is not a 

Party. 

For that reason, we think that it is vital that the Congress take action quickly to adopt 

H.R. 4591 and allow the United States to join these agreements and deal effectively with their 

implementation at both the domestic and international level. In ACe's view, H.R. 4591 is the 

best vehicle for integrating TSCA and U.S. obligations under the agreement. 
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III. H.R. 4591 Addresses the Key Required Changes in U.S. Statutory Authority 

The three international agreements only require modest statutory changes to TSCA. 

These include: 

• Extending EPA authority to prohibit export of current POPs substances for purposes 

prohibited by the Convention. 

• Imposing certification requirements for exports to countries not party to the POPs 

agreements. 

• Codifying the treaty exemptions in TSCA. 

Integrating the Rotterdam PIC export notification provisions into existing TSCA export 

notification requirements. 

In ACC's view, there is no real disagreement that these elements must be addressed in 

implementing legislation. 

The single most controversial issue with respect to these treaties has been how to handle 

future decisions to add new POPs substances under the agreements as a matter of U.S. law and 

regulation. 

The POPs agreements do not obligate the Parties to establish mechanisms to address 

future treaty amendments like new chemicals, and the United States could limit its implementing 

changes to the targeted fixes noted above. But the treaties contemplate the possibility that 

chemicals will be added to the list of covered substances in the future, and ACC shares the view 

that legislative economy suggests an adding mechanism should be considered for the legislation. 

ACC therefore supports the establishment of a new domestic process that would give EPA 

special new authority to prohibit or restrict the manufacture, use, or export of POPs substances 

listed by future decisions under the treaties. 

The Stockholm Convention establishes a process by which a new chemical will be added 

to the list of POPs: 

I. A Party nominates a chemical for consideration as a POP substance. 

2. The treaty Secretariat reviews the nomination to ensure that it meets the minimum 

criteria established in Annex D (e.g., that the nomination includes information on the 

persistent, bioaccumulative, and toxic properties of the substances, and the propensity 

for long-range transport). lfthe nomination meets the criteria, it is forwarded to the 

POPs Review Committee (POPRC). 

3. The POPRC reviews the nomination, and if further consideration is warranted, the 

Committee requests information necessary to prepare a Risk Profile on the substance 

pursuant to Annex E. 

4. The POPRC reviews the Risk Profile. lfthe POPRC decides that further 

consideration is warranted because long-range transport of the substance will lead to 

significant health or environmental impacts such that global action is necessary, the 

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Committee requests information to prepare a risk management evaluation, including 

information on the socio-economic benefit and alternatives to the nominated 

substance, pursuant to Annex F. 

5. On the basis of the risk management evaluation, the POPRC makes a 

recommendation to the Conference of the Parties (COP) whether the chemical should 

be listed in Annex A, B or C of the treaty. 

6. The COP then decides whether to amend the Convention to include the new chemical 

on one of the Annexes. 

H.R. 4591 requires EPA to provide public notice and an opportunity to comment at each 

decision point in this process upon the nomination of a substance, the preparation of the risk 

profile and risk management evaluation, and the recommendation to the COP. The process will 

provide ample public notice of activities under the treaties, and it will assure that U.S. 

representatives in the POPRC and the COP have all relevant information before them at each 

stage of the international process. 

More importantly. the international agreements adopt a l1exible approach to risk 

management measures. For example, elimination of a substance is not a legal requirement for a 

POP substance, but constitutes one option to manage the risks of a POPs release. A domestic 

regulatory process is required to provide the United States sufficient l1exibility to determine how 

it will regulate a particular substance and what, if any, critical uses or exemptions might be 

necessary. The domestic process should include the risk and cost/benefit considerations 

envisioned in the treaty. Further, as the treaty provisions and annexes make clear, risk and 

costlbenefit considerations are not trumped by the need for precaution. Rather, those 

considerations give substance to the precautionary decisions made through the treaty process. 

H.R. 4591 appropriately rel1ects these risk management considerations in a domestic 

regulatory process for new POPs substances that mirror the procedural and substantive decisions 

under the Stockholm Convention and the LRT AP POPs ProtocoL When a new substance is 

adopted under one of these agreements, EPA is granted special new authority to regulate these 

newly listed substances "to the extent necessary to protect human health and the environment in a 

manner that achieves a reasonable balance of social, environmental, and economic costs and 

benefits." In reaching its regulatory decision, EPA is to consider: 

• The etTects and magnitude of the effects of the substance on health or the environment. 

• The benefits of the substance and the availability, risks and economic consequences of 

alternatives to the substance. 

• The economic consequences of the proposed risk management requirement. 

• The domestic and international consequences likely to arise as a result of the domestic 

regulatory action. 

EPA is also authorized to consider additional information in the domestic or international record. 

The decision-making standard and the first three required elements in EPA' s regulatory 

considerations provide the necessary domestic counterpart to the process outlined in the POPs 
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agreements. The treaties require that relevant social, economic, environmental and health 

information is considered in reaching a decision to list a new chemical; H.R. 4591 ensures that 

the same information is considered in reaching a domestic decision. Between the notice and 

comment requirements and the international process, EPA will have a robust domestic and 

international record to consider in reaching a domestic regulatory decision - and a sufficient 

opportunity to ensure that the record supports its subsequent regulatory actions. 

H.R. 4591 sends a powerful signal to those governments that arc attempting to weaken 

the risklbenefit approach set out in the POPs agreements. To date, the international process for 

evaluating new chemicals is only in the initial stages, but some governments are working to 

remove or dilute the criteria for evaluating new chemicals, including the evaluation of risk, costs 

and the potential consequences and risks of any alternatives and potential risk management 

measures. These efforts further reinforce the need for a clear domestic regulatory process. 

The domestic regulatory process in H.R. 4591 sends a clear signal that in order to ensure 

that the United States can be party to a treaty amendment to list a new chemical, the record must 

provide appropriate support. The international agreements adopt a risk/benefit approach in 

implementing appropriate regulatory controls on listed chemicals, and in considering chemicals 

nominated as potential POPs. The agreements rely on technical and economic considerations to 

ensure that priority pollutants are targeted and meaningful control actions taken on a global basis. 

H.R. 4591 does no less - and supports the appropriate use of analytical tools such as risk 

assessment and cost/benefit analysis that EPA already employs in its decisions to manage the 

risks of chemicals. 

Section 6 ofTSCA already provides EPA the necessary authority to prohibit or restrict 

the manufacture, processing, use, distribution or disposal of a chemical substance. Due to the 

special global considerations that apply to substances nominated as POPs, the chemical industry 

has been willing to consider an appropriately narrow modification to the approach used in TSCA 

Section 6. For example, the H.R. 4591 imposes no requirement on EPA to demonstrate that a 

substance poses an "unreasonable risk" to health or the environment, does not require EPA to 

demonstrate that its preferred risk managcment approach is the "least burdensome regulatory 

alternative," and imposes none of the procedural elements of Section 6, such as the informal 

hearings required for proposals under that section. 

We also note that H.R. 4591 does not prevent EPA from regulating POPs substances 

under its existing statutory authority, including TSCA. The United States regulated the existing 

POPs long before the international agreements were drafted, employing a regulatory process that 

considered scientific evidence, risks to health and the environment, and socio-economic 

consequences. The domestic POPs process established in H.R. 4591 simply adapts existing 

requirements in a manner that ensures the United States can meet its international obligations. 

H.R. 4591 also appropriately establishes a requirement that the Executive Branch consult 

with Congress as amendments to the treaty obligations are considered. This provision constitutes 

no restriction on the President's power to conduct foreign policy, and ensures that Congress is 

made aware of significant developments in the future implementation of the agreements. 

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IV. Conclusion 

The American Chemistry Council believes that the Stockholm Convention, LRTAP 

Protocol, and Rotterdam Convention are significant steps in securing international action on 

chemicals through coordinated risk management at the global level. The agreements establish a 

harmonized approach tor action on listed chemicals, and should produce meaningful 

improvements in public health and environmental protection. The United States must become a 

Party to the agreements as soon as possible. 

H.R. 4591 fully implements U.S. obligations under the three agreements into TSCA. It 

complements EPA's existing regulatory authority, provides proper public notice and an 

opportunity to comment at all stages of the international process, and ensures that the United 

States can cooperate with the international community in addressing global risks. We commend 

Mr. GiI!mor for introducing this bill, and urge the Subcommittee and Congress to take quick 

action on the legislation to ensure that the United States can once again fill its leadership role in 

international chemical regulatory matters. 
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merican' Chemistry Council 

10 Principles for Modernizing TSCA 

Attachment B 

The American Chemistry Council and its members support Congress' effort to modernize our 

nation's chemical management system. Such a system should place protecting the public health 

as its highest priority, and should include strict government oversight. It should also preserve 

America's role as the world's leading innovator and employer in the creation of safe and 

environmentally sound technologies and products of the business of chemistry. 

The current chemical management law, the Toxic Substances Control Act (TSCA), is more than 

30 years old. It should be modernized to keep pace with advances in science and technology. 

Moreover, the law must provide the Environmental Protection Agency with the resources and the 

authority to do its job effective(v. 

We have previously (iffered general concepts on which to base a modern chemical management 

system. This document expands upon those concepts and begins to provide more detail, which we 

hope will be useful to policy makers. We will continue to refine the details of our principles for 

modernizing TSCA and are committed to working with all stakeholders toward enactment of 

effective legislation. 

1. Chemicals should be safe for their intended use. 

Ensuring chemical safety is a shared responsibility of industry and EPA. 

Industry should have the responsibility for providing sufficient information for EPA to 

make timely decisions about safety. 

EPA should have the responsibility for making safe use determinations for high priority 

chemicals, focusing on their most significant uses and exposures. 

Safe use determinations should integrate hazard, use, and exposure information, and 

incorporate appropriate safety factors. 

Consideration of the benefits of chemicals being evaluated. the cost of methods to 

control their risks, and the benefits and costs of alternatives should be part of EPA' s risk 

management decision making, but should not be part of its safe use determinations. 

Other agencies, such as FDA and CPSC, should continue to make safety decisions for 

products within their own jurisdictions. 

2. EPA should systematically prioritize chemicals for purposes of safe use determinations. 

Government and industry resources should be focused on chemicals of highest concern. 

americanchemistry.com· 13L1() \Nilson Boulcyard. Arlington. VA 222091 (703) 741.:3tXIO "f; 
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The priorities should reflect considerations such as the volume of a chemical in 

commerce; its uses, including whether it is formulated in products for children; its detection in 

biomonitoring programs; its persistent or bioaccumulative properties; and the adequacy of 

available information. 

3. EPA should act expeditiously and efficiently in making safe use determinations. 

Since a chemical may have a variety of uses, resulting in different exposure potentials, 

EPA should consider the various uses and focus on those resulting in the most significant 

exposures. 

EPA should complete safe use determinations within set time frames. 

4. Companies that manufacture, import, process, distribute, or use chemicals should be required 

to provide EP A with relevant information to the extent necessary for EPA to make safe use 

determinations. 

Companies throughout the chain of commerce should be responsible for providing 

necessary hazard, use, and exposure information. 

EPA should be authorized to require companies, as appropriate, to generate relevant new 

data and information to the extent reasonably necessary to make safe use determinations 

without having to prove risk as a prerequisite or engaging in protracted rulemaking. 

Testing of chemicals should progress to more complex and expensive tests through a 

tiered approach as needed to identify hazards and exposures of specific concern. 

To minimize animal testing, existing data should be considered prior to new testing, and 

validated alternatives to animal testing should be used wherever feasible. 

Existing data and infonnation should be leveraged in EPA's safe use determinations. 

including data and information from other mandatory and voluntary programs such as 

REACH and the U.S. High Production Volume challenge. 

5. Potential risks faced by children should be an important factor in safe use determinations. 

Safe use determinations should consider the effects of a chemical on children and their 

exposure to the chemicaL 

Safe use determinations should consider whether an extra margin of safety is needed to 

protect children. 

6. EPA should be empowered to impose a range of controls to ensure that chemicals are safe for 

their intended use. 

The controls could range from actions such as labeling, handling instructions, exposure 

limits and engineering controls to use restrictions and product bans. 
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The controls should be appropriate for managing the risk, taking into account 

alternatives, benefits, costs, and uncertainty. 

7. Companies and EPA should work together to enhance public access to chemical health and 

safety information. 

EPA should make chemical hazard, use, and exposure information available to the public 

in electronic databases. 

Other governments should have access to confidential information submitted under 

TSCA, subject to appropriate and reliable protections. 

Companies claiming confidentiality in information submittals should have to justify 

those claims on a periodic basis. 

Reasonable protections for confidential as well as proprietary information should be 

provided. 

8. EPA should rely on scientifically valid data and information, regardless of its source, 

including data and information reflecting modem advances in science and technology. 

EPA should establish transparent and scientifically sound criteria for evaluating all of the 

information on which it makes decisions to ensure that it is valid, using a framework that 

addresses the strengths and limitations of the study design, the reliability of the test methods, 

and the quality of the data. 

EPA should encourage use of good laboratory practices, peer review, standardized 

protocols, and other methods to ensure scientific quality. 

9. EPA should have the staff; resources, and regulatory tools it needs to ensure the safety of 

chemicals. 

EPA's budget for TSCA activities should be commensurate with its chemical 

management responsibilities. 

10. A modernized TSCA should encourage technological innovation and a globally competitive 

industry in the United States. 

A new chemical management system should preserve and enhance the jobs and 

innovative products and technologies contributed by the business of American chemistry. 

Implementation ofTSCA should encourage product and technology innovation by 

providing industry certainty about the use of chemicals. 
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WRITTEN STATEMENT OF 

NATIONAL PETROCHEMICAL & REFINERS ASSOCIATION (NPRA) 

AS SUBMITTED TO THE 

SUBCOMMITTEE ON COMMERCE, TRADE AND CONSUMER PROTECTION 

Committee on Energy & Commerce 

V.S. House of Representatives 

on 

"TSCA (Toxic Substanccs Control Act) and Pcrsistcnt, Bioaccumulative, and Toxic 

Chemicals: Examining Domestic and International Actions." 

March 4, 2010 
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Introduction 

NPRA, the National Petrochemical & Refiners Association, appreciates the opportunity to 

submit written testimony for today's hearing examining persistent, bioaccumulative and toxic 

(PBT) substances. Our association represents more than 450 businesses, including virtually all 

U.S. refiners and petrochemical manufacturers, their suppliers, and vendors. NPRA members 

supply consumers with a wide variety of products used daily in their homes and businesses, 

including fuels, lubricants, and chemicals that serve as building blocks for everything from 

plastics to clothing, medicine, and computers. 

Background and Overview 

NPRA considers the existing federal chemicals regulatory framework to be a strong foundation 

for the protection of consumer health and the environment, while simultaneously allowing for the 

devclopment of products that enhance our standard of living. NPRA and its members support a 

responsible update of the nation's chemicals risk management regulatory framework. Within 

that context. we understand the Subcommittee's interest in how the federal government should 

best address persistent, bioaccumulative and tox ic substances. 

Defining Persistence, Bioaccumulation and Toxicity 

Through the Organization for Economic Cooperation and Development (OEeD), intcrnational 

consensus has been achieved among regulatory scientists regarding how to appropriately define 

certain chemicals as persistent, bioaccumulative and toxic. The United States should adhere to 

those definitions and not diverge into its own classification scheme, which would create a 

patchwork of varying definitions for PBTs throughout different regions. 

Because of advances in analytical chemistry techniques, a substance should not necessarily be 

classitied as bioaccumulative simply if trace (parts per billion or trillion) amounts are found in 

biomonitoring studies. Scientists are still trying to interpret the implications of finding this many 

previously undetected suhstances in the human body at these extremcly low levels. It is thus 
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premature to draw any kind of regulatory conclusion regarding bioaccumulation until there is 

clear international consensus among regulatory scientists through the DECO. 

Consistent with international scientific consensus, a particular substance should not be classified 

as a PBT unless it is persistent, bioaccumulative and toxic. Possessing just one or two of these 

traits does not present the same potential hazard as possessing all three and should not be viewed 

as such. 

Risk Management for PBTs 

Risk management tor PBTs should follow the same approach as for any other chemical. A 

particular PBT, like any other substance, should not automatically be considered a high risk 

because of its inherent properties. Persistence can be a valuable trait for materials that need to 

withstand harsh environments. Bioaccumulation does not mean that safety is jeopardized. The 

human body accumulates, metabolizes and excretes many naturally occurring toxic substances 

every day. Certain PBTs have been used safely for years in industrial settings by controlling 

releases and exposures. 

Conclusion 

NPRA supports Congress providing EPA the authority to regulate persistent, bioaeeumulative 

and toxic substances. The United States should continue to follow international consensus 

through the DECO on the definitions ofpersistence, bioaccumulation and toxicity, and on 

classifications ofPBTs. PBTs should be evaluated for risk in the same manner as any other 

substance in commerce and subjected to a tiered and targeted approach to risk management. 
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EPA RESPONSES TO CONGRESSIONAL QUESTIONS FOR THE RECORD 

March 4, 2010 PBT Hearing 

House Energy and Commerce 

Sub-Committee on Commerce, Trade, and Consumer Protection 

September IS, 2010 

The Honorable Bobby l. Rush 

1. Biomonitoring can be used to determine the amount that people are actually exposed to 

certain chemicals. At our last hearing on TSCA in November, we heard from the Centers for 

Disease Control and Prevention about their biomonitoring program. Their fourth 

biomonitoring report found "widespread" exposure to emerging chemicals of concern. These 

include PBTs such as perfluorinated compounds (PFOA) and flame retardants (PSDEs). 

a. Do you believe that if a chemical is found to contaminate the human body, there is 

exposure? 

Yes, although presence in the body alone does not tell us what the resulting risk of the chemical 

may be to human health. The presence of a chemical in the human body is a key factor in 

Agency decision making regarding both toxicity testing and risk mitigation of chemicals. A 

number of the Agency's risk reduction actions under TSCA have been focused on chemicals 

found in the human body in biomonitoring studies, for example, penta- and octabromodiphenyl ether as well as a broad class of PFOS and PFAC chemicals. Biomonitoring 

information is also a selection criterion for the new EPA chemical action plans recently 

released, and action plans where this was a factor include polybrominated diphenyl ethers, 

phthalates, long-chain perfluorinated compounds and short chain chlorinated paraffins. 

b. Do you believe once we know that a chemical is a PST and there is exposure, this is 

sufficient information for EPA to take immediate action to reduce or eliminate the use of 

PBTs? 

Exposure to a PBT is potential cause for concern, although presence in the body alone does not 

tell us what the resulting risk of the chemical may be to human health, Having said that, as a 

result of the legal hurdles and procedural requirements TSCA places on EPA prior to collecting 

data, there are large, troubling gaps in the available data and state of knowledge on many 

widely used chemicals in commerce. Although there is a review process for new chemicals 

being introduced into commerce, chemical producers are not required to provide, without 

further action from EPA, the data necessary to fully assess a chemical's risks. 

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In the cases where EPA has adequate data on a chemical, and wants to protect the public 

against well-known risks to human health and the environment, there are legal hurdles that 

prevent quick and effective regulatory action. Meanwhile, the public may be exposed to 

chemicals for which we have little understanding of the consequences. 

When Administrator Jackson announced that EPA would be taking action on a number of 

chemicals, she noted criteria EPA would use to identify these chemicals. 1 PST characteristics 

were among those criteria. In fact, three of the four chemical groups selected for the initial 

group of action plans were PBTs. 

c. If we know that something is a PBT but we do not know if there is exposure, does EPA think 

it would be a priority to find out if there is exposure? Can EPA act on PBTs without exposure 

information? 

Persistence and bioaccumulation, as well as toxicity, are certainly very important factors in 

evaluating a chemical's risks. Filling in gaps in exposure information for PBTs would be a high 

priority. Currently, under TSCA, exposure information is necessary to determine whether an 

existing chemical presents or may present an unreasonable risk. The response to the following 

question outlines EPA's Policy Statement for the consideration of PSTs during the review of 

new chemicals under TSCA. 

d. Do you believe newly developed chemicals that meet the criteria for being a PBT should be 

restricted from entering commerce? 

As outlined in the Administration's principles on TSCA reform, we believe that chemicals should 

be reviewed against safety standards that reflect risk-based criteria protective of human health 

and the environment, and that EPA should have clear authority to take risk management 

actions when chemicals do not meet the safety standard. 

That a chemical is persistent and bioaccumulative, as well as toxic, is certainly a very important 

factor in evaluating a chemical's risks and prioritizing chemicals for action. PBT characteristics 

are among the factors the Agency has considered in identifying chemical substances for action 

in both its enhanced existing chemicals management program and its new chemicals program. 

Beginning in 1988, EPA first used its accumulated experience to group certain chemical 

substances with similar physicochemical, structural, and toxicological properties into categories 

to enable both Pre-Manufacture Notice (PMN) submitters and EPA reviewers to benefit from 

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the accumulated data and decisional precedents for the assessment and regulation of new 

chemical substances, In 1999 (Federal Register, 11/4/1999, page 60194-60204), EPA issued a 

final policy statement regarding the category of persistent, bioaccumulative, and toxic (PST) 

new chemical substances, Through the Policy Statement, EPA adopted specific identification 

criteria and the associated process that EPA would use in evaluating new chemical substances 

suspected as being persistent bioaccumulators, The Policy Statement made clear to submitters 

of new chemical notifications under TSCA section 5 that substances meeting these criteria may 

need to undergo testing on "P" and "B" endpoints which, if confirmed, would be followed by 

appropriate toxicity testing to identify "PBT chemical substances," In addition, the Policy 

Statement made clear that control action under TSCA section 5(e) may be needed in varying 

degrees, based upon the level of risk concern, 

e, When there is known exposure to a persistent and bioaccumulative chemical but toxicity is 

not known, do you believe that this chemical should be limited in commerce or prioritized for 

toxicity testing? 

There are large, troubling gaps in the available data and state of knowledge on many 

widely used chemicals in commerce, Although there is a review process for new 

chemicals being introduced into commerce, chemical producers are not required to 

provide, without further action from EPA, the data necessary to fully assess a chemical's 

risks, If toxicity is unknown for chemicals known to be persistent and bioaccumulative, this 

would be an important data gap which should be filled, 

As outlined in the Administration's principles on TSCA reform, we believe that chemicals should 

be reviewed against safety standards that reflect risk-based criteria protective of human health 

and the environment, and that EPA should have clear authority to take risk management 

actions when chemicals do not meet the safety standard, 

2, The National Research Council in a 2005 report has found biomonitoring to be a "tool with 

great potential," and the GAO recently testified that EPA has not sufficiently used available 

biomonitoring data in its chemical risk assessments, 

a, Does EPA consider the presence of persistent and bioaccumulative chemicals in the human 

body to be a trigger for toxicity testing or risk mitigation? 

That a chemical is persistent and bioaccumulative, as well as toxic, is certainly a very important 

factor in evaluating a chemical's risks, When Administrator Jackson announced that EPA would 

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be taking action on a number of chemicals, she noted criteria EPA would use to identify these 

chemicals. 2 PBT characteristics were among those criteria. 

EPA has used persistence, bioaccumulation, and toxicity (PBT) characteristics in determining 

toxicity testing needs and risk mitigation activities in the New Chemical Program for over 20 

years. Beginning in 1988, EPA first used its accumulated experience to group certain chemical 

substances with similar physicochemical, structural, and toxicological properties into categories 

to enable both PMN submitters and EPA reviewers to benefit from the accumulated data and 

decisional precedents for the assessment and regulation of new chemical substances. In 1999 

(Federal Register, 11/4/1999, page 60194-60204), EPA issued a final policy statement regarding 

the category of persistent, bioaccumulative, and toxic (PBT) new chemical substances. 

Through the Policy Statement, EPA adopted specific identification criteria and the associated 

process that EPA would use in evaluating new chemical substances suspected as being 

persistent bioaccumulators. The Policy Statement made clear to submitters of new chemical 

notifications under TSCA section 5 that substances meeting these criteria may need to undergo 

testing on "p" and "B" endpoints which, if confirmed, would be followed by appropriate 

toxicity testing to identify "PBT chemical substances." In addition, the Policy Statement made 

clear that control action under TSCA section 5(e) may be needed in varying degrees, based 

upon the level of risk concern. 

More recently, EPA has had the opportunity to incorporate biomonitoring information in 

conjunction with PBT information in the Existing Chemical Program. In 2005, EPA's Science 

Advisory Board reviewed a draft risk assessment of perfluorooctanoic acid (PFOA). This 

assessment was one of the first examples of the use of human biomonitoring and 

pharmacokinetic modeling in assessing potential human risks, and in fact was highlighted in 

NRC 2006 report on biomonitoring. The biomonitoring information, in conjunction with the 

PBT characteristics of PFOA, formed the rationale for the risk mitigation activities and the 

phase-out of PFOA (as well as the earlier phase out of PFOS). In addition, this information has 

formed the basis for the toxicity testing requirements, and risk mitigation activities, of all new 

perfluoro compounds submitted through the PMN program. In September 2009, EPA 

announced efforts to enhance the Agency's current chemical management progam, which 

includes the development and release of chemical specific action plans. To date, the Agency 

has released five action plans, including several chemicals which were selected, in part, on 

biomonitoring information, and/or known PBT properties, including perfluoroalkyl acids, PBDEs, 

BPA, and phthalates. 

'http:! www.epa.gov/opptiexistingchemicaisipubs!Existing.Chem.Fact.sheet.pdf 

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b. Does EPA have a plan for utilizing biomonitoring data for identification of exposure to 

persistent and bioaccumulative chemicals? 

Characteristics of persistence and bioaccumulation and biomonitoring data are among the 

factors the Agency has considered in identifying chemical substances for action in its enhanced 

existing chemicals management program and will continue to use these factors. In addition, 

the Great Lakes Restoration Initiative (GLRI) is undertaking a biomonitoring study of intensive 

Great Lakes fish consumers with a focus on chemicals of emerging concern such as brominated 

flame retardants and perfluorinated compounds. The GLRI is a five year mUlti-agency effort to 

restore and maintain the chemical, physical, and biological integrity of the Great Lakes. Under 

the GLRI, significant new investments are being made to address PBTs, including pollution 

prevention efforts, such as implementation of the Great Lakes Regional Collaboration Mercury 

in Products and Waste Phase-down Strategy, as well as in green chemistry and product 

stewardship activities in the Great Lakes basin. Efforts include further monitoring and 

surveillance for new and emerging chemicals in the Great Lakes through expanded fish and air 

deposition monitoring and a new sediment core program to help identify new chemical 

toxicants which may pose threats to human health and the environment3 

3. Mr. Jones, we heard you describe what the EPA is currently doing on PBTs. However, EPA 

drafted a document in 1998 entitled "Multimedia Strategy for Priority Persistent, 

Bioaccumulative, and Toxic (PST) Chemicals." In the years since, it does not appear that that 

draft document was ever finalized. 

a.ls there a plan under this Administration to finalize this strategy document? Similarly, EPA's 

website says that the PST program is no longer active. Can you elaborate on this? Do the new 

chemical action plans you explained in your testimony replace this older PST program? 

EPA does not intend to finalize this document. EPA's current enhanced existing chemicals 

program, which includes the development and implementation of action plans for chemicals 

that EPA believes may pose environmental or public health concerns, has superseded this 

program. Persistence and bioaccumulation, as well as toxicity, are very important factors in 

evaluating a chemical's risks. 

4. EPA's recently announced action plans on 4 chemicals included 3 PSTs. 

3 http://greatlakesrestoration.us/ 

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a. Do you have any indication how many more chemical action plans in the pipeline will be 

for PBTs? You have action plans for non-PBTs. With limited resources, is there a preference 

given to PBTs for an action plan? 

At this point, we cannot say how many future action plans may address PBTs. Persistence and 

bioaccumulation, as well as toxicity, are very important factors in evaluating a chemical's risks. 

b. How many actions plans should we expect in total? 

As of August 20, 2010, EPA has made public eight chemical specific action plans. EPA will 

continue to address chemicals that EPA believes may pose environmental or public health 

concerns. 

c. How many PBTs are currently being used in commerce? How many PBTs are no longer used 

in commerce, yet are still contaminating the environment and our bodies? 

We do not know exactly how many exist and their status in commerce. There are more than 

84,000 chemicals on the TSCA Inventory, and the Inventory does not include pesticides and 

other chemicals subject to other statutes. EPA does, however, have information on some new 

and existing TSCA chemicals. Starting in Fiscal Year 2001, about 6% of all New Chemical notices 

have been determined to be PBTs. About 2% of more than 2200 existing chemicals in the High 

Production Volume Challenge program were identified as PBTs using EPA's PBT Profiler 

screening tool and the new chemicals program protocols. 

d. Does EPA know how many new PBTs have entered into commerce since TSCA was enacted 

in 1976? 

The Agency did not begin tracking PBTs until Fiscal Year 2001. Starting in 2001, about 6% of all 

New Chemical notices have been determined to be PBTs, for a total of 680 through 2008. 

There does not seem to be a discernible trend that we can identify, but the range is from a low 

of 56 in 2008 to a high of 109 in 2002. 

5. Mr. Sturdevant emphasized the need to transition towards safer alternatives where PBTs 

are currently used in commerce. To determine safety, we need information on a chemical's 

toxicity. Currently, EPA is limited in its ability to get this information. 

a. Is there a process in place at EPA to require or encourage switching to safer alternatives, as 

suggested by Mr. Sturdevant? 

The Design for the Environment (DfE) Program in EPA pursues two different approaches to 

promote the transition from chemicals that may pose environmental or public health concerns, 

including PBTs, to scientifically proven safer alternatives. Under the first approach, the 

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Program conducts the Safer Product Labeling program to encourage formulators of cleaning 

and other products to reformulate away from chemicals that may pose environmental or public 

health concerns towards safer substitutes. The Program uses the Agency's toxicological, 

chemistry and other scientific expertise to screen chemicals and recommend safer 

replacements. Products which meet the criteria for every chemical ingredient in the product 

are allowed to affix a DfE logo to their product asserting safer chemistry.4 

When safer alternative chemicals are not readily available or not widely used in an industry, DfE 

uses a different approach, named Alternatives Assessment, to identify and evaluate safer 

chemicals. These Alternatives Assessments are a collaborative effort with leaders in industry, 

NGOs, agency scientists and, as appropriate, academic or other stakeholders. Agency science is 

used to understand the potential for environmental and human health impacts of the 

alternatives and enable a move to safer chemicals. 

The Honorable Ed Whitfield 

1. During questioning, I asked what the process was for adding chemicals to the TRI list. 

Please state for the record what that process is. 

The toxic chemicals subject to the TRI requirements are those chemicals on the list in 

Committee Print Number 99-169 of the Senate Committee on Environment and Public Works, 

titled "Toxic Chemicals Subject to Section 313 of the Emergency Planning and Community RightTo-Know Act of 1986" and any revisions to the list as may be made pursuant to subsection (d) 

or (e) of Section 313. The current list has over 600 individually listed chemicals and about 30 

chemicals categories. 

EPCRA 313(d) provides the authority to add a chemical to the TRI list if the Administrator 

determines, in his or her judgment and based on available and generally accepted scientific 

principles or laboratory tests, or appropriately designed and conducted epidemiological or 

other population studies, that there is sufficient evidence to establish anyone of the following: 

The chemical is known to cause or can reasonably be anticipated to cause significant 

adverse acute human health effects at concentration levels that are reasonably likely to 

exist beyond facility site boundaries as a result of continuous, or frequently recurring, 

releases. 

, http;i;www.epa.gov/dfeipubs/projectsigfcp'index.htlll. 

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The chemical is known to cause, or can reasonably be anticipated to cause in humans (1) 

cancer or teratogenic effects, or (2) serious or irreversible reproductive dysfunctions, 

neurological disorders, heritable genetic mutations, or other chronic health effects. 

The chemical is known to cause or can reasonably be anticipated to cause, because of its 

toxicity, its toxicity and persistence in the environment, or its toxicity and tendency to 

bioaccumulate in the environment, a significant adverse effect on the environment of 

sufficient seriousness, in the judgment of the Administrator, to warrant reporting under 

this section. 

EPA must make such a determination by rule. Additions would be proposed through 

publication of a draft rule to provide notice and opportunity for comment on the addition of 

the chemical to the TRI list. A final rule would be subject to judicial review. A similar process 

would occur to delete a listed chemical if the Administrator determined there was not sufficient 

evidence to establish any of the criteria described above for the chemical. 

Under EPCRA 313(e), any person may petition the Administrator to add or delete a chemical 

and the Administrator must take action within 180 days. 

The TRI regulations were augmented with respect to persistent bioaccumulative toxic (PBT) 

chemicals on October 29, 1999, when EPA published a final rule adding some PBT chemicals to 

the list of toxic chemicals subject to section 313 of EPCRA and section 6607 of the PPA and to 

lower the reporting thresholds for certain PBT chemicals including mercury, dioxin, and PCBs. 

2. How does a chemical, like Metiram, which the toxicity test showed was not causing a 

problem in animals, make the list? 

Based on the 1994 rulemaking record, Metiram is an ethylene bisdithiocarbamate (EBDC) 

fungicide, and EPA found that sufficient evidence suggested that ethylene bisthiocarbamate 

fungicides and ethylenethiourea (a common contaminant, metabolite, and degradation product 

of these fungicides) caused cancer and adverse developmental effects in experimental animals.s 

In a 2-year diet study, ethylenethiourea caused liver adenomas and carcinomas in mice, and 

thyroid follicular cell adenomas and carcinomas in mice and rats. 6 A NOAEL of less than or 

equal to 5 mg/kg has been reported for ethylenethiourea, based on a rat developmental 

559 FR 1863. 1/12/1994 

6 Support Document for the Health and Ecological Toxicity Review ofTRI Expansion Chemicals. U.S. 

Environmental Protection Agency. Washington. DC (1993), page 95. 

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toxicity study.7 Ethylenethiourea caused delayed ossification or hardening of the parietal bone 

in pups. EPA believed then, as it does now, that there is sufficient evidence for listing metiram 

on the EPCRA section 313(c) list pursuant to EPCRA section 313(d)(2)(B) based on the 

carcinogenicity and developmental toxicity data for ethylenethiourea, a metabolite and 

degradation product of metiram. 

3. Please state whether chemicals have been statutorily added to the TRI. Please state 

whether any of their toxicity profiles are similar to or more benign than that for Metiram. 

All of the chemicals that were originally on the TRI list were statutorily added in Committee 

Print Number 99-169 of the Senate Committee on Environment and Public Works, titled "Toxic 

Chemicals Subject to Section 313 of the Emergency Planning and Community Right-To-Know 

Act of 1986." 

No chemicals have been added statutorily since the adoption of the law. 

With respect to your question regarding whether the toxicity profiles of any of the statutorily 

added chemicals are similar to or more benign than that for metiram, since there have not been 

any statutory additions, the Agency does not have anything upon which to base an answer to 

this question. 

4. Please provide a full explanation of the steps EPA must take to ban a PST. Please state 

whether there are legal authorities other than TSCA to address PST chemical risks. 

Section 6(a) of TSCA gives EPA the authority to protect against unreasonable risk of injury to 

health or the environment from chemical substances. If EPA finds that there is a reasonable 

basis to conclude that the chemical's manufacture, processing, distribution, use or disposal 

presents an unreasonable risk, EPA may by notice-and-comment rulemaking take action to: 

Id. 

• Prohibit or limit manufacture, processing, or distribution in commerce; 

• Prohibit or limit the manufacture, processing, or distribution in commerce of the 

chemical substance above a specified concentration; 

• Require adequate warnings and instructions with respect to use, distribution, or 

disposal; 

• Require manufacturers or processors to make and retain records; 

• Prohibit or regulate any manner of commercial use; 

• Prohibit or regulate any manner of disposal; and/or 

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• Require manufacturers or processors to give notice of the unreasonable risk of injury, 

and to recall products if required. 

TSCA section 6(a) indicates that EPA should apply the least burdensome means of adequately 

protecting against the unreasonable risk. In developing a rule under 6(a), TSCA section 6(c) 

directs EPA to consider and publish a statement with respect to: 

1. The effect of the chemical substance being regulated on health and the magnitude of 

exposure of humans to the substance. 

2. The effects of such substance on the environment and the magnitude of exposure of the 

environment to the substance. 

3. The benefits of such substance for various uses and the availability of substitutes for 

such uses. 

4. The reasonably ascertainable economic consequences of the rule, after consideration of 

the effect on the national economy, small business, technological innovation, the 

environment, and public health. 

Only five ban actions have been taken using this authority since TSCA was enacted, along with 

the predominantly invalidated Asbestos Ban and Phase-out Rule. The 5th Circuit Court of 

Appeals decision on the asbestos rule in 1991 had a chilling effect on EPA's use of the TSCA ban 

authority. To the extent EPA has authority to address chemicals in the various media it 

regulates, it also has the authority to address PBT chemicals. While the PBT nature of the 

chemicals may be relevant to a risk finding or Agency priority setting, most EPA authorities do 

not treat PBTs differently as a class. (Note, though, that PBT-listed chemicals are subject to 

lower thresholds to trigger Toxies Release Inventory reporting. See 40 C.F.R. § 372.28.) Thus 

EPA has the broad range of authorities in the environmental statutes available to address PBTs. 

The Honorable Joe Barton 

1. Please state whether the U.S. EPA was the source for recognition and inclusion of Article 

3.3 in the Stockholm Convention concerning new chemicals with POPs characteristics. If not, 

please explain why this fact was stated in EPA's notice finalizing existing U.S. PBT policy. 

As of the date of the issuance of the final PBT policy (November 4, 1999), the negotiation of the 

Stockholm Convention was ongoing and thus Article 3.3 did not yet exist. As stated in the 

Federal Register Notice announcing the category for PBT new chemical substances: 

N ••• development of the TSCA new PBT chemicals policy has occurred in coordination 

with U.s. national, U.S'/Canada binational, and international efforts to identify and 

control the environmental release of persistent organic pollutants (POPs). The proposed 

TSCA PBT category has been provided to the Criteria Expert Group (CEG) established at 

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the first session of the Intergovernmental Negotiating Committee (INC) for an 

International Legally Binding Instrument for Implementing International Action on 

Certain Persistent Organic Pollutants, in accordance with the mandate given by the 

Governing Council of the United Nations Environment Programme (UNEP) in paragraph 

9 of its decision 19/13 C (http://irptc.unep.ch/pops/gcpops<INF>-</INF>e.html). The 

CEG is an open-ended technical working group with a mandate to present to the INC 

proposals for science-based criteria and a procedure for identifying additional POPs as 

candidates for future international action. The CEG is to incorporate criteria pertaining 

to persistence, bioaccumulation, toxicity and exposure in different global regions and 

should take into account the potential for regional and global transport, including 

dispersion mechanisms for the atmosphere and the hydrosphere, migratory species, 

and the need to reflect possible influences of marine transport and tropical climates. At 

its first meeting, October 26-30, 1998 in Bangkok, the CEG recommended that the INC 

consider developing a provision encouraging countries and regions to include in their 

new chemicals schemes elements relating to development and introduction of new 

chemical POPs. The U.S. described its proposed TSCA new chemicals program policy for 

the category of PBT new chemicals, and the full text of the October 5, 1998 Federal 

Register notice was distributed to all delegations as a Conference Room Paper. The 

CEG's recommendation was accepted at the second meeting of the INC (January 25-29, 

1999 in Nairobi) and the INC will consider it further in its deliberations." (64 FR 60194, 

November 4, 1999). 

2. Please state whether EPA's policy for new psr chemicals followed a foreign policy or was 

the first of its kind internationally. 

EPA's policy for new PBT chemicals was the first of its kind internationally, although certain 

other governments (e.g, Japan) also recognized PBTs as chemicals of potential concern in their 

domestic regulatory regimes. 

3. Has the existing psr policy been effective -- in that companies have avoided the 

development and submission of new chemical paTs except in cases where the exposures and 

releases were carefully controlled or avoided entirely? 

Through the 1999 Policy Statement on New Chemicals Category for PBTs, EPA adopted specific 

identification criteria and the associated process that EPA would use in evaluating new 

chemical substances suspected as being persistent bioaccumulators. The Policy Statement 

made clear to submitters of new chemical notifications under TSCA section 5 that substances 

meeting these criteria may need to undergo testing on "P" and "B" endpoints which, if 

confirmed, would be followed by appropriate toxicity testing to identify "PBT chemical 

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substances." In addition, the Policy Statement made clear that control action under TSCA 

section 5(e) may be needed in varying degrees, based upon the level of risk concern. 

Because EPA is not privy to company business decisions regarding which new chemical 

substances should be developed, it is not possible for EPA to comment on whether companies 

have avoided the development and submission of new chemical PBTs since the issuance of this 

policy statement. During the period from FYOI - FY08, EPA received approximately 290 PreManufacture Notices (PMNs) or Significant New Use Notices (SNUNs) and 370 low Volume 

Exemption notifications (lVEs) that were identified by the Agency as "potential" PBTs. There 

does not appear to be a strong trend over this time period. During its review of "potential" PBT 

notifications, EPA carefully assesses the chemical substance to ensure that exposures and 

releases are carefully controlled or avoided entirely. EPA will, if necessary, deny an lVE and/or 

require binding controls on releases and exposures. For PMNs, EPA will, if necessary, regulate 

the substance through TSCA section 5(e) Consent Orders/Significant New Use Rules (SNURs), 

non-5(e) SNURs, or will ban the manufacture of the substance pending the development of 

upfront testing needed by EPA to conduct a reasoned evaluation of the effects of the 

substance. 

4. On Thursday, February 4, 2010, U.s. EPA deleted its web pages specifically designed to 

address PBT issues. Apparently, the Agency did this to archive materials that were as old as 

2002. However, the "archive" contains materials newer than 2002. Please explain why those 

materials newer than the archive guidelines were archived and what criteria were used in 

determining which materials to archive. 

We archived the site because the program had been superseded by the enhanced existing 

chemicals program. However, there are links to active efforts including the PBT Profiler, the 

Toxics Release Inventory program, and some activities ongoing in EPA's Region 5. 

5. EPA's web page states "The PBT program is no longer active." Please explain this statement 

and whether it means EPA no longer supports its new chemicals PBT policy. 

EPA continues to implement its new chemicals policy for PBTs. The PBT program referenced on 

the EPA website addressed existing chemicals and has been superseded by the enhanced 

existing chemicals program. This program was and is unrelated to EPA's New Chemicals policy 

for PBTs. 

6. Other than taking down the PBT website, please describe what actions the Obama 

Administration has taken to demonstrate its support for the Sustainable Futures effort. 

Please describe what improvements, if any, have occurred on your watch. 

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The Sustainable Futures Program has been strengthened and enhanced during the Obama 

Administration. Under Sustainable Futures, EPA offers industry and other stakeholders' 

powerful computerized methods for the evaluation of chemicals. EPA delivers these tools 

together with training, technical assistance and regulatory incentives for qualifying New 

Chemicals developed using the Sustainable Futures tools. In December 2009, EPA launched 

the Analog Identification Methodology (AIM), a web-based tool to facilitate hazard assessment, 

promote risk reduction, facilitate informed substitution, foster pollution prevention outcomes, 

and advance the state-of-the-art in chemical risk assessment. AIM is available at 

http://aim.epa.gov. AIM has been well received by stakeholders, with over 6,700 AIM 

assessments conducted in the first four months of public release. 

7. Work on implementing the Stockholm POPs Convention has progressed since the 

Convention entered into force. Despite EPA Administrator Whitman, in May 2001, making the 

United States a signatory to this Convention by signing the agreement, the United States 

Senate has not ratified the agreement, and Congress has not approved the necessary 

statutory changes to TSCA and FIFRA required to fully implement the treaty obligations. 

a. Please describe the U.S. government's experience with implementation of the Convention 

since it entered into force. 

The Parties have been actively implementing the Convention, including adding nine POPs to the 

Treaty last year. While the United States has been able to provide technical assistance and 

capacity-building to help other countries implement their obligations, as a non-party, we are 

unable to participate fully in the political or technical aspects of the proceedings 

as the agreement evolves over time and additional chemicals are added to its scope. Had the 

United States been a Party, we would have been afforded the opportunity to participate in the 

decisions to add the nine additional substances. The United States may have also had the 

opportunity to playa leadership role in determining the direction of these and other decisions 

taken by the members of the Convention. 

b. Please state whether the new chemical listing process has proceeded as the United States 

anticipated under the treaty as negotiated. 

Yes, the listing process has proceeded as anticipated. As stated above, as a non-party, we are 

unable to participate fully in the political or technical aspects of the proceedings as the 

agreement evolves over time and additional chemicals are added to its scope. Had the United 

States been a Party, we would have been afforded the opportunity to participate in the 

decisions to add the nine additional substances. The United States may have also had the 

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opportunity to playa leadership role in determining the direction of these and other decisions 

taken by the members of the Convention. 

c. Please state whether the treaty as implemented has changed in any respect from the treaty 

as negotiated by the United States. 

The treaty has been amended to include a new Annex G on Arbitration and Conciliation 

Procedures for Settlement of Disputes, and to include nine new POPs in the Convention. These 

chemicals are Pentachlorobenzene, C-Octabromobiphenyl ether components, CPentabromobiphenyl ether components, Alpha HCH, Beta HCH, Gamma HCH, Chlordecone, 

Hexabromobiphenyl, and PFOS. 

8. EPA established a PMN policy with respect to new PBr chemicals in 1999. 

a. Please explain the Agency's experience implementing that policy. 

Through the 1999 Policy Statement on New Chemicals Category for PBTs, EPA adopted specific 

identification criteria and the associated process that EPA would use in evaluating new 

chemical substances suspected as being persistent bioaccumulators. The Policy Statement 

made clear to submitters of new chemical notifications under TSCA section 5 that substances 

meeting these criteria may need to undergo testing on "P" and "B" endpoints which, if 

confirmed, would be followed by appropriate toxicity testing to identify "PBT chemical 

substances." In addition, the Policy Statement made clear that control action under TSCA 

section 5(e) may be needed in varying degrees, based upon the level of risk concern. 

During its review of "potential" PBT notifications, EPA carefully assesses the chemical substance 

to ensure that exposures and releases are carefully controlled or avoided entirely. EPA will, if 

necessary, deny an LVE and/or require binding controls on releases and exposures. For PMNs, 

EPA will, if necessary, regulate the substance through TSCA section 5(e) Consent 

Orders/Significant New Use Rules (SNURs), non-5(e) SNURs, or will ban the manufacture of the 

substance pending the development of upfront testing needed by EPA to conduct a reasoned 

evaluation of the effects of the substance. 

During the period from FY01 - FY08, EPA received approximately 291 Pre-Manufacture Notices 

(PMNs) or Significant New Use Notices (SNUNs) and 369 Low Volume Exemption notifications 

(LVEs) that were identified by the Agency as "potential" PBTs. All of these were 

regulated/restricted by EPA in some fashion or were withdrawn by the submitter during the 

review period. LVEs that were not withdrawn were either denied by EPA or were bound to the 

terms of the exemption notice (Le., strict control on releases and exposures). All of the 

PMNs/SNUNs that were not withdrawn were regulated with 5(e) Consent Orders/SNURS, non5(e) Consent Orders, or were banned pending upfront testing. 

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Of the section 5 notices submitted between FYOI thru FY08, we identified the chemicals in 369 

low Volume Exemptions and 291 PMNs/SNUNs as potential PBTs. 

b. Please state the number of new PBT substances that have been introduced into commerce 

since 1999. 

The Agency did not begin tracking PBTs in the new chemicals program until Fiscal Year 2001. 

Starting in Fiscal Year 2001, about 6% of all new chemical notices have been determined to be 

PBTs, for a total of 680 through 2008. There does not seem to be a discernible trend that we 

can identify, but the range is from a low of 56 in 2008 to a high of 109 in 2002. 

c. Please describe the risk management measures, if any, the Agency required for those 

substances. 

In our new chemicals program, it is our policy to ban Pre-Manufacture Notice chemicals that 

have a persistence >6 months and bioaccumulation >5000 pending upfront testing, and, for 

chemicals with persistence >2 months and bioaccumulation >1000, to regulate under a TSCA 

section 5(e) order to control exposures and releases, and to require testing. 

Based on section 5 notices, between FY01 thru FY08 we identified the chemicals in 369 LVEs 

and 291 PMNs/SNUNs as potential PBTs. All of these were regulated/restricted by EPA in some 

fashion or were withdrawn by the submitter during the review period. l VEs that were not 

withdrawn were either denied by EPA or were bound to the terms of the exemption notice (I.e., 

strict control on releases and exposures). The PMNs/SNUNs that were not withdrawn were 

regulated with 5(e) Consent Orders/SNURS, non-5(e) Consent Orders, or were banned pending 

upfront testing. 

d. Please state whether the PMN policies have been effective in minimizing or eliminating 

risks to human health or the environment, and if so, how. 

EPA believes the implementation of the 1999 Policy Statement on New Chemicals Category for 

PBTs has led to the identification and risk management of PST chemicals within the New 

Chemicals program. Through the Policy Statement, EPA adopted specific identification criteria 

and the associated process that EPA would use in evaluating new chemical substances 

suspected as being persistent bioaccumulators. The Policy Statement made clear to submitters 

of new chemical notifications under TSCA section 5 that substances meeting these criteria may 

need to undergo testing on "P" and "B" endpoints which, if confirmed, would be followed by 

appropriate toxicity testing to identify "PST chemical substances." In addition, the Policy 

Statement made clear that control action under TSCA section 5(e) may be needed in varying 

degrees, based upon the level of risk concern. 

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Starting in Fiscal Year 2001, about 6% of all New Chemical notices have been determined to be 

PBTs, for a total of 680 through 2008. Based on section 5 notices, between FY01 thru FY08 we 

identified the chemicals in 369 LVEs and 291 PMNs/SNUNs as potential PBTs. All of these were 

regulated/restricted by EPA in some fashion or were withdrawn by the submitter during the 

review period. lVEs that were not withdrawn were either denied by EPA or were bound to the 

terms of the exemption notice (i.e., strict control on releases and exposures). The 

PMNs/SNUNs that were not withdrawn were regulated with 5(e) Consent Orders/SNURS, non5(e) Consent Orders, or were banned pending upfront testing. 

9. Please describe any steps the Agency is taking to address the findings of the 2008 Society 

of Environmental Toxicology and Chemistry's Pellston Workshop on PST characteristics. 

Please also describe how the Agency is incorporating the developing science and better 

identifying PST substances identified by that Pellston workshop, the goal of which was to 

improve the process of identification and evaluation of chemicals against the PST criteria. 

The Pellston Workshop are Society of Environmental Toxicology and Chemistry (SETAe) 

sponsored meetings whose purpose is to evaluate current and prospective environmental 

issues. At the 2008 Pellston Workshop, the principal objective was to develop consensus 

guidance on how to evaluate chemicals using scientific information such as experimental data, 

monitoring data, and computer models to determine if they fulfill PBT criteria (Kleeka et aI., 

IEA&M 2009, 5:535-538). The workshop results have been presented in a series of technical 

papers in the October 2009 issue of the journal Integrated Environmental Assessment and 

Management (IEA&M). 

Efforts to improve our program in this area include employing a dedicated team of senior 

scientists to perform predictive calculations for industrial chemicals; updating our 

bioaccumulation model to include an absorption, distribution, metabolism and excretion 

(ADME) component which predicts the metabolism of chemicals; and incorporating 

environmental compartment-specific half-lives into the evaluation of chemical persistence. 

10. Please describe the impact of EPA's New Chemicals PST Policy on the number of new PST 

chemicals. Of the new PST chemicals of which EPA has been notified, please state the general 

trend for release of these chemicals into the environment? 

EPA did not begin tracking PBTs in its new chemicals program until Fiscal Year 2001. Starting in 

FY2001, about 6% of all new chemical notices have been determined to be PBTs, for a total of 

680 through 2008. There does not seem to be a discernible trend that we can identify, but the 

range is from a low of 56 in 2008 to a high of 109 in 2002. Based on section 5 notices, between 

FY01 thru FY08 we identified the chemicals in 369 LVEs and 291 PMNs/SNUNs as potential 

PBTs. All of these were regulated/restricted by EPA in some fashion or were withdrawn by the 

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submitter during the review period. LVEs that were not withdrawn were either denied by EPA 

or were bound to the terms of the exemption notice (Le., strict control on releases and 

exposures). The PMNs!SNUNs that were not withdrawn were regulated with 5(e) Consent 

Orders!SNURS, non-5(e) Consent Orders, or were banned pending upfront testing. 

11. Your testimony references EPA's PBT Profiler tool, which I have been told was designed 

largely for industry's use in designing safer/greener new chemicals. Please generally identify 

the primary users of this tool and describe the benefits derived from that use. 

The PBT Profiler was designed to be used by public stakeholders with a wide variety of technical 

skills and expertise and was jointly developed by industry, Environmental Defense, and EPA. It 

was released to the public in 2002. 

The PBT Profiler interprets the results for non scientists so that a broader array of stakeholders 

can assess PBT characteristics. The user base of the PBT Profiler is wide and diverse. The 

methodology is used by industry, the public, NGOs, academic and research institutions, State 

environmental agencies, and other parts of the u.s. Federal Government, among others. 

Stakeholders have conducted over 200,000 chemical specific PBT screening studies using the 

PBT Profiler. 

The PBT Profiler offers users many benefits. The tool can be used to estimate PBT 

characteristics for new chemicals and can be used to compare and contrast existing chemicals 

for PBT characteristics. This can help drive informed chemical substitution and identify 

pollution prevention and risk reduction opportunities. As examples, Bayer Chemical Company 

used the PBT Profiler to compare and contrast alternatives at research and development phase 

for a new chemical. The Dutch Government used the Profiler to evaluate 50 chemicals 

detected in harbor sediments. The Federal Aviation Administration used the Profiler to 

evaluate safety of chemicals used in aircraft components. SC Johnson evaluated chemicals in 

their supply chain for PBT characteristics. FMC Corporation evaluated 50 chemicals for PBT 

traits. 

12. In responding to a question from Representative Whitfield on the difference in legal 

standards between TSCA chemicals and FIFRA pesticides, you mentioned the pesticide 

standard of "reasonable certainty of no harm". Please state whether there are distinct 

differences between routes of exposure for pesticides, governed under FIFRA, versus other 

chemicals which could be subject to TSCA. 

Yes, "reasonable certainty of no harm" is the standard for issuing pesticides tolerances from the 

Food Quality Protection Act and the "no significant adverse effects" language is from TSCA. The 

potential routes of exposure assessed under FIFRA and TSCA are the same; dermal, inhalation, 

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ingestion (humans), and environmental; it is the context in which those exposures occur that 

may differ. 

Under FIFRA, exposure scenarios are evaluated for all uses of pesticides, such as agricultural 

applications, home and garden (consumer or certified applicator) applications, and institutional 

and industrial applications. For example, application of a pesticide/herbicide to a field crop can 

potentially result in dermal and inhalation exposure to the farmer/applicator and bystander; in 

run-off to streams and wells with subsequent drinking water (ingestion) exposure to the 

general population as well as environmental exposure to terrestrial and aquatic organisms; and 

in ingestion or dietary exposure to the general population from consumption of food. As 

another example, indoor insecticides are assessed for potential dermal and inhalation 

exposures to applicators/consumers. 

Under TSCA, exposure scenarios for industrial chemicals can include dermal and inhalation 

exposures to industrial workers during manufacturing and processing, inhalation exposures to 

the general population due to the volatility of the compound or during incineration of wastes, 

drinking water (ingestion) exposure to the general population as well as environmental 

exposures to aquatic organisms from releases to water during manufacturing, processing or 

use, and dermal and/or inhalation exposures to consumers if the chemical is incorporated into 

a product (powder, liquid, or article). 

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RESPONSE TO U.S. COMMITTEE ON ENERGY & COMMERCE, 

TSCA & PBT CHE1\HCALS HEARING ON 3/4/10 

By: Ted Sturdevant, Director' 

WA State Department of Ecology 

The Honorable Bobby L. Rush: 

1. !ifr. Sturdevant, YOIl ell/phasized the need to transitioll towards safer alternatives where PBTs are 

cli/'relllly lIsed in cOlI/merce. To determine safety, we need information 011 a chemical's toxicity. 

Currently, EPA is limited ill its ability to get this information. }dr. Sturdevallt, given the ClIrrenl 

limitations of TSCA, how can we know if there are safer altematives for current lIses of P BTs? 

Your query raises two fundamental questions: 

1. How do we determine how safe a particular chemical is? 

2. How do we compare chemicals to detelmine which ones are safer than others? 

I'll speak to the second question first. There are a number of tools currently available to determine the 

relative safety of various chemicals. As in other states, we in Washington State have worked with the 

creators of a tool called GreenScrecn to develop an effective, consistent tool for this VC1Y purpose. There 

are other tools as well, including EPA's Design for Environment Program. However, we would be well 

served by a consistent, effective approach to making this determination. We're getting there, but more 

work is needed. 

The bad news, as your question points out, is that there is no effective mechanism to ensure that chemical 

data is available so that we can perform these analyses. Instead, we arc forced to hunt around the world 

for study results on a particular chemical, investigate the studies to ensure they are valid, and hope tbey 

provide the data needed for accurate comparison to alternative chemicals. Even when such data exists, it 

is often classified as confidential business information, and unavailable. 

The Washington Slate Depmiment of Ecology was faced with this question two years ago when we 

sought to determine whether safer alternatives were available for PBDE flame retardants in computers, 

televisions and upholstered furniture. Using publically available data, information from Europe, and a 

variety of studies on toxicity of the identified alternatives, we were able to identify at least one safcr 

alternative foJ' each of these product types. This was an arduous and lengthy process, leading to three 

additional years of deca-BDE use in consumer products while we waited for sufficient data so that we 

could make a valid comparison. Even this process would not be possible for evelY chemical and product 

we wish to investigate, because the data doesn't exist or is confidential. 

The fact that the public should be forced to endure ongoing toxic exposures because manufacturers are 

not required to ascertain and share safety data rcflects the imbalance of the current system. To answer 

your question directly - "Holl' eml we know if there are safer altel'llotil'es for cllrrent uses (!f P BT.I? "-

the answer, uufortunately, is that we have to get lucky and be able to find sufficient data on a chemical 

and its alternatives to determine which is safer. This is why TSCA reform should require manufacturers 

to provide adequate toxicity information to regulators - both to demonstrate their products are safe before 

they cnter the market, and to enable us to find safer alternatives. But until we have the data and the 

consistent means fol' comparison, we can and should operate on the assumption that PBTs are worse than 

nOll-PBTs, and act accordingly. 
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Ted Sturdevant, Director 

Washington State Depmimcnt of Ecology 

Response to U.S. Committee on Energy & Commerce, 

TSCA & PBT Chemicals Hcaring on 3/4/10 

The HOllol'able Joe Barton: 

1. Your testimony references the state ofWashillgtOI1 ban on certainflame retardant chemicals known as 

PEDEs. Please state whether this ban perm/ts the lise of PEDEs in any capacity IInder Washington State 

lmv. Jjyes, please explain how YOII reconcile the permissible lise of PEDEs with your statemelll that 

these chemicals are the "worst Cirthe 1I'0lwt. " 

Washington State's ban on PBDEs targeted the largest uses of these chemical flame retardants. For two 

PBDE formulations, penta-BDE and octa-BDE, all uses were banncd, with exemptiollsprovided for 

transportation vehicles and eql1ipment, militmy and aviation uses, medical devices, and sale of used 

products. For the deca-BDE form, the ban applies only to mattresses, televisions, computers, and 

residential upholstered fumiture after it was shown that safer alternatives were available for these uses. 

In determining what should and should not be banned, the Washington State Legislature weighed risk 

against the availability of safer alternatives, and against the negative effects of a ban. Based on that 

analysis, the legislature crafted a reasoned, but protective ban. 

Banning a chemical is a serious undertaking and should not be done lightly. It requires a careful analysis 

and balancing of the threats posed by its use, as well as the benefits. We, do not maintain that evelY use of 

evelY PBT should be banned tomorrow. This would be irresponsible. Likewise, given the particular 

threats posed by PBTs, it is iITesponsible not to move away from them as quickly as is reasonably 

possible.' If a safer alternative exists for a pattieular use of a PBT, it makes sense to ban the PBT and 

switch to the safer alternative. Ifno safer alternative exists, and the particular else of a PBT poses a 

danger to the public and is used in a non-essential 01' unimportant way, then it makes sense to ban that 

use. Admittedly, defining "potential danger" and "non-essential or unimportant" demand poli<?y 

decisions, but we should not shy away from making those decisions. In all cases, I believe that we should 

err 011 the side of protecting human health and the environment, paliicularly those most vulnerable, such 

as fetuses, infants, and children. 

2. This COlllmittee has repeatedly heard testimony thalmakiug prevelltative decisions based upon 

incomplete or unverifiable science has dramatic impacts on people's lives. YOll supported a 

precalitiOlwlJ' approach to regulation ill YOllr testimony. Please stale whether you slipporl a 

precalltiOllmJ' approach even when regulation is based IIpon a scienlific study that is 110t supported by 

valid science, the measurements of the silbst(llIces in-the study are 1I0t authentic or sufficiently precise for 

their intended lise, the cOllditions of the scientific study are lIOt well controllecl, and the results cannot be 

replicated by otlier scientists. 

No, I do not SUppOit making decisions based on bad science. Good science is clearly the foundation of 

good chemical policy. I do advocate a precautionary approach, but one that is informed by good science 

and common sense. In the debate over chemicals policy, the word "prccautionary" often is misinterpreted 

to mean that maximum safety is the only consideration that should be used to infol1n decision making. 

When crossing a busy street, it is precautionary to wait for the traffic light, look both ways, and proceed 

with caution. It doesn't mean you shouldn't leave home in the morn ing. 

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Ted Sturdevant, Director 

Washington State Department of Ecology 

Response to U.S. Committee on Energy & Commerce, 

TSCA & PBT Chemicals Hearing on 3/4/1 0 

So it is with chemicals policy. Given (he well established ability of chemicals to travel and persist, it 

defies common sense to asselt a policy that docs not have precaution as a core clement. But sound 

science is also a necessary element, and the two arc not mutually exclusive. There is rarely such a thing 

as "scientific certainty," uor can we often prove the absolute absence of risk. To allow this to prevent us 

from exercising common sense in making policy decisions is wrong. r fmiher believc that if we are to tilt 

one way or another - toward protecting people from harm, or toward protecting manufacturers from 

making changes - I think the precantious choice is clearly the right one. 

3. YOII suggested we sholild eliminale Ihe lise of PETs by forcing the lise of allemalil'e subslances thai 

can peliorm Ihe same tasks in a safer manner. }VIs. Greer testified Ihat PCBs were once thought to be 

nonthreatening based on the science of that time. Please slate when YOll consider a chemical, e.g., a 

substilllie for a pBY; to hm'e been studied enough to assul'e the public il is safe. Please also stale on what 

you base yow' conc/usion. 

There is a big difference between "safe" and "safer." Determining the relative safety of two different 

chemicals is something we can do, if we have access to data on those chemicals. Establishing that 

something is safe, or 100 percellt free of risk, is not something we can do. To use a cliche, it is said that: 

"One can drown in a tablespoon of water." Is water "safe?" 

Concems over the safety of PCBs began to appear in the 1930s. As those concerns grew, if a valid 

scientific comparison had detennined an alternative to be safer than PCBs, then I believe it would have 

beenrcsponsible to force the use of the alternative at any point. Had we dono so, rather than wailing 40 

years for the growing weight ofthe data 10 force a ban, Washington State taxpayers would be saving 

millions of dollars each year that we otherwise spend on ongoing PCB cleanup. 

4. You testified, "State-by-state, chemical-by-chemical approaches are not efficient or effective ways to 

address PETs, which do 110t I'espectjurisdiclional boundaries." Yet, y01l1' state was aggressive ill 

opposing pal's implementing legislation in the 101" Congress because Y01l argued that state sovereignty 

was more important than an overall federal structllre and having 0111' Execlltive Branch set treaty policy 

was of lesser illlporiance. Please explain why YOIlIIOW think state environmentallegis/alion is no /ongel' 

preferable to federal environJlleJlt((llaws. 

Washington State supports development of a strong federal system to regulate chemicals; however, we 

believe such a system should be the "floor," and not the "ceiling." States need to be able to build from 

this foundation and protect their citizens as needed. The advances made by lllany states in preventing 

toxic exposures would not have been possible had TSCA contained a blanket preemption on such 

activities for the past 30 years. A patchwork of state approaches is preferable to a weak federal system. 

But a strong federal system is preferable to a patchwork approach. 
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Ted Sturdevant, Director 

Wash ington State Department of Ecology 

Response to U,S, Committee on Energy & Commerce, 

TSCA & PET Chemicals Hearing on 3/4/10 

Individual states find it challenging to drive changes hi the supply chain through legislation injust one 

state, and oul' capacity to fund the research and assllmc the political fights is limited. Likewise, 

manufacturers find it challenging to design different products for different states. If stronger protections 

were afforded across the nation, states would not be compelled to take individual action Hearly as often as 

we do. But even lmder a strong federal system, the states will and should continue to innovate in order to 

fill in gaps in protection as they are nceded, It should not be a question of slate cnvironmentallaws 01' 

federal environmcntallaws - we need both, and we liced both to work. 

Regarding POPs legislation, HR 4591 contained such broad preemption language that we believed it 

would significantly limit Washington State's ability to protect the public from the POPs Treaty chcmicals, 

It would have removed the ability for any state to take any action on a treaty chemical beyond the 

restrictions adopted by EPA, with the exception of a complete ban or a restriction adopted under the 

Clean Air Act or another federullaw. We argued against this restriction because we believe that it is vital 

to preserve the ability for states to fill ill gaps in federal protections, 

5.· l~Jlltestifiedtl/{lf we should han PBTs and establish a systelllforfinding safer altematives, 

a. Please stale whether yo II support a han 011 the use ofPBTs in products important to the COIlI1/Jy'S 

needs. 

b, Please state whether YOIl support a han Oil the use of PBTs even ifsllitable alternative canllot be 

foul1d 

c. Please state whether you sllpport a ban 011 the lise of PBT's even if the allel'11ative is unproven as a 

suitable substitute, its h(izard and exposure data III/supported hy the science, and its lise is 

IInavailable to the marketplace for years. 

Any ban should carcfully consider a number of factors including whether or not a safer alternative is 

available, the magnitude of the risk posed by the chemical, as well as thc necessity ofthe product in 

question, Washington State's ban ofPBDEs is a good example of this type of assessment. Decisions 

should be based on the best available scientific data and consideration of the factors mentioned above. 

As for banning PETs before a safer alternative is available, it depends on the necessity ofthe patiicular 

use. If using that chemical is the only way to flame retard an airplane escape ramp, a ban probably 

doesn't make sense. But if it is the only way to ensure that a blinking light goes on in a child's tennis 

shoe when he walks, a ban might make good sense even if 110 alternative exists. 

6. Your testimony ineludes a resoilltionfrom Washingtoll {lnd12 a/her stale envirollmelllal progral11s in 

support of certain principles for chemicals management reforl11, represelllingjllst 26 percellt (abOlll one 

in fOIll) of all states, 

a. Please state whether you sellttlie resolution to all 50 states, 

b. Please provide the names of those siales, if all)" thaI deelinedlo sign the resoilitioll. 

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Ted Sturdevant, Director 

Washington State Department of Ecology 

Response to U.S. Committee 011 Energy & Commerce, 

TSCA & PBT Chemicals Hearing on 3/411 0 

The resolution was based ou similar efforts by the U.S. EPA and the National Conference of State 

Legislators to articulate principles for TSCA reform. Several states with existing chemicals policy reform 

efforts were interested in collaborating to avoid duplication of dIort at the federal level. Our common 

experience in strengthening protections in our respective states left us with a sharcd understanding ofthe 

inadequacy of protection under TSCA. 

Fifteen states werc invited to join as they were known to us to be active in Green Chemistry and 

chemicals policy reform efforts through execntive orders, consumer product bans, chemicals policy 

refonn statutes and interstate collaboration on safer chemicals. Minnesota and Virginia did not respond to 

the invitation. 

After the resolution was signed by 13 states, the resolution was disseminated by the Environmental 

Council oflhe States (ECOS) to aliSO stales. Additional states were not asked to sign the resolution. 

-LQc:M Ted Shn'devant, Director 

W A State Department of Ecology 

Submitted: Apri19, 2010 

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April 9, 2010 

Honorable Ilenry A. Waxman 

Chairman 

Committee on Energy and Commcrce 

U.S. House of Representatives 

2125 Rayburn House Office Building 

Washington, DC 20515 

Attention: Earley Green, Chief Clerk 

Dear Chairman Waxman; 

Thank you for the opportunity to appear before the Subcommittee on Commerce, Trade and Consumer 

Protection on March 4, 2010 at the hearing entitled "TSCA and Persistent, Bioaeeumulativc and Toxic 

Chemicals: Examining Domestic and lnternalioml Actions." 

I appreciated the 0ppOliunity as a private citizen and tcehnical expert to contribute to Congress's 

discussions on this vcry important topic. As a consumer and citizen of the United States, I am as 

concerned as you arc about chemicals that may be in commerce and that could cause adverse impacts on 

mc, my family and the environmcnt. Furthermore since I have worked on the development of the PHT 

criteria and the methods for identifying and evaluating the safety of PBTs in severa! national and 

international fora within thc US, Canada, Europe and the United Nations, I appreciated the oppOliunity to 

provide to this cOlllmittee the history and scientific progress that has been made of the PBT screening and 

assessment process. 

If you, Representative Rush, or Representative Barton, would have any additional questions or seck 

clarification on any of my responses, you can contact me. 

Sincerely, 

Christina E. Cowan-Ellsbcrry, Ph.D. 

CE' Consulting, LLC 

77 I 6 Stonehenge Dr 

Cincinnati, OIl 45242 

T: 513-791-4879 

M: 513-240-6689 

E: cel!sberry@gmail.colll 
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The Honorable Bobby L. Rush 

1. Dr. Cowan-Ellsberry, you noted in your testimony that an effective PBT program "will encourage 

technical innovation of new chemicals and products" that will improve lives and benefit our citizens. 

This is a laudable goal. No one wants an effective PBT program to be detrimental to innovation. How 

do we get there? 

The key components to an effective PBT program that will encourage technical innovation of new 

chemicals and products will include 

Transparency in the data and the process used to determine if the chemical meets the criteria 

and definition of a PBT. This transparency is illustrated by the development and public 

distribution of the PBT Profiler that can be used to determine, for many, but not all chemicals, 

an initial estimate of a chemical's PBT properties. 

Adoption of a risk-based review process that considers the use and exposure pattern for a given 

PST rather than making a decision based solely on the hazard characteristics of the substance. 

Public comment process that encourages the involvement of scientists in industry, academia 

and environmental groups who have data and information that can be used to inform any PST 

evaluation of a specific chemical. 

Incorporation of the most current science and scientific understanding in assessments 

Management actions that include reasonable timeframes and evaluation of any "replacements" 

to demonstrate that their risk profile is an improvement. 

The Honorable Joe Barton 

1. You state: "based on the vetting and discussion there is now international consensus that the UN 

Stockholm Convention and the Canadian TSMP criteria are SCientifically-based and appropriate 

because these criteria are now incorporated into many national PBT regulatory programs". Are you 

referring to Annex 0, E, and F of the Stockholm Convention, related to the POPROC? If so, please 

explain the importance of having these tools when setting chemicals policy? Is the U.S. TSCA's 

program more mature and nimble than others in this regulatory universe? 

As background to this question, Annex D of the Stockholm Convention contains criteria for screening 

chemicals for Persistence, P, and Sioaccumulative, S, properties, Potential for Long-range Environmental 

Transport and Adverse Effects. Annex E contains a list of the additional information that can be used to 

prepare the Risk Profile which further elaborates on and evaluates the Annex E information and in 

addition, specifically evaluates if the chemical, as a result of its long-range transport, leads to significant 

adverse human and/or environmental effects, such that global action is warranted. Annex F contains a 

list of the relevant information relating to socio-economic considerations that are associated with each 
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possible control measure. The Canadian Toxic Substance Management Policy (TSMP) contains criteria 

for screening chemicals for P and B properties. As I state in my testimony and illustrate in Table 1, there 

is agreement on the B criteria between these two conventions and substantial agreement on the P 

criteria. Furthermore, the criteria used by US EPA for their new chemical evaluation are in agreement 

with these criteria. The three distinctive step process outlined in Stockholm Conventions Annexes D, E 

and F, should be included in any PBT program under TSCA. 

EPA's actions in the 1990's to incorporate PBTscreening into PMN assessments and how they've 

embedded PBT evaluations into the choice of substances to regulate in the RCRA and TRI programs plus 

the EPA's very rapid actions on perfluoro-chemicals (e.g., PFOS), which were followed and adopted 

globally, demonstrates that EPA was definitely on the forefront of PBT screening and management and 

when necessary EPA can take action. What is needed to ensure an effective TSCA modernization 

program for PBT chemicals and to ensure continuing effective actions by EPA is to specifically include a 

thorough priority setting for chemicals in active commerce. 

2. You state that the "process [to identify PBT substances and conduct risk-assessments] can be 

scientifically challenging". Is this arduousness necessary? In your opinion, would a slimmed down 

assessment process present any real advantages from a scientific standpoint? Is there is a specific 

amount of time that is required for good science to occur? 

Although this process can be scientifically challenging, it does not need to be unduly arduous or take an 

unlimited amount of time. Rather it is more important that resources and commitment is made by all 

parties to reach the final determination. When a chemical is in commerce it is providing a recognizable 

benefit to society. While screening and priority setting for chemicals can and should happen in a 

reasonably rapid timeframe, unless there is an imminent risk, no specific timeframe should be 

designated for coming to the final conclusion that the chemical is a PBT and for instituting management 

programs, if needed. Instead emphasis should be placed on considering all data and the full weight of 

evidence as well as the benefit to society to ensure that any final conclusion and management decisions 

do not result in an unnecessary burden on society. Thus, the most important part of this process is to 

ensure that the most appropriate and current information and understanding is used to make this 

determination and to allow sufficient time for addressing questions, developing new data and 

information as appropriate, ensuring that there is confidence in the weight of the evidence and in the 

final determination 

3. Are you concerned that incomplete assessments or hurried decisions based upon incomplete 

science will have negative effects or consequences? 

a. Why do you consider the "strict pass or fail" criteria that exists for PBTs, like in Europe, to be 

problematic beyond initial screening of substance characteristics? Please explain how the regulatory 

criteria/framework does not allow for consideration of the evolved state of the science? Should we 

be concerned about changes to TSCA that would use this kind of effort? 

As mentioned in the response to the previous question, when a chemical is in commerce it is providing a 

recognized benefit to society so it is not to the benefit of society to make a hasty decision based on 
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limited information. Unless there is convincing evidence that these chemicals in commerce pose an 

imminent and present threat and that suitable and safer replacements exist, allowing time for a 

thorough evaluation before taking any action is to the benefit of society. For example, moving 

immediately toward management of a chemical based on whether it meets a set of "strict pass or fail" 

criteria would not allow for evaluation of the full weight of evidence. In fact, a regulatory 

criteria/framework that does not allow for consideration of advances in the state-of-the-science and 

understanding will inherently lead to decisions that in my opinion could later be determined to be 

inappropriate. Thus, any revision to TSCA that will include explicit evaluation and management of PBTs 

needs to ensure that there is sufficient flexibility and time in the final PBT determination to allow for the 

consideration of the evolved state of the science in the weight of the evidence. 

4. Last week, Dr. Christopher Borgert testified before another one of our subcommittees his concerns 

with the four pillars of science. He said that they were: measurability, reproducibility, relevance, and 

reliability. You mention: "the modernization of TSCA should be flexible to incorporate new, validated 

methods that use advance state-of-the-science methods. Do you agree with Dr. Borgert? How does 

this comport with the overall general PBT discussion? 

When evaluating whether new methods and their results should be included in a specific PST 

assessment, I agree with Dr. Borgert that these same four pillars of science should be considered and 

used to inform the incorporation of these advanced methods in these assessments. This approach also 

agrees with the recommendations from the Pellston workshop. 

S. Please identify what you consider to be the weaknesses in the Canadian and European methods for 

characterizing and regulating PBTs, and whether there exists a potential negative impact due to these 

weaknesses. 

My biggest concern with both of these programs is that they appear in their early stages of 

implementation, to not allow for incorporation of the newly developed and advanced methods of 

evaluation and additional data beyond those directly addressing whether the substance strictly meets 

the P or B or T criteria. For example, the basis for the scientific concern represented by the 

bioaccumulation criteria is whether a substance increases in concentration in organisms higher in the 

food chain. But Canada and Europe do not use information on the fate of a chemical in a food chain to 

inform the bioaccumulation assessment because the focus of the current approach is only on whether 

the substance meets the Bionconcentration Factor criteria. As previously stated, a hasty decision that a 

chemical is a PBT and instituting management without evaluating the full weight of evidence could 

result in a negative impact on society that could have been avoided. 

Secondly, within the Canadian and European PBT regulations, the PB& T criteria are decoupled resulting 

in substances that meet only one or two of the criteria being prioritized for action. Because these 

programs fail to evaluate the PBT characteristics in total including a risk-based assessment followed by a 

cost-benefit analysis, this results in longer lists of chemicals on which action is taken, dilutes the focus 

from the highest priority substances and promotes hasty action. The TSCA reform should maintain an 

emphasis on those chemicals that meet all three of the criteria and on a thorough assessment. 
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6. You testified it is "not possible to predict the final number of PBT substances currently in commerce 

nationally and internationally". Please explain your statement. Please also explain how you conclude 

that the number of PBTs in the environment to "appear[s) to be less than 100". 

First, it is important to recognize that there is no international consensus on the exact number of 

chemicals in commerce; this is part of the reason that it is not possible to predict the final number of 

PBT substances. Never-the-Iess, evaluations of large numbers of chemicals using similar screening 

criteria (see Table 1 of my testimony) have all resulted in less than 100 chemicals tentatively identified 

as PBTs. For example, the Canadian program for evaluating the 23,000 Domestic Substance List (DSL) 

chemicals for PBT chemicals identified only 77 high priority PST chemicals. Similarly, the EU PBT 

evaluation of their 2683 high production volume chemicals resulted in identification of 24 PBT 

chemicals. The number of chemicals brought forward to the Stockholm Convention for global 

management is also much less than 100. Furthermore, many of these identified PBT chemicals do not 

appear to be currently in commerce, are waste products, or are used as site-limited intermediates. With 

the implementation of PBT screening into the evaluation of New Chemical substances, it is highly 

unlikely that new PBT chemicals will enter into commerce. Thus, while we won't know exactly how 

many chemicals actively produced and released to the environment in the U.S. will end up being 

prioritized for assessment, all these pieces of data support my conclusion that the number of PBT 

chemicals appears to be less than 100. 

While a recent publication (Howard and Muir 2010) based on model predictions and expert judgment 

evaluations has been reported to conclude that there are hundreds of P&B chemicals in active 

commerce, a review of the basis for these reports suggests that this is not an appropriate representation 

of their work. For example, the authors clearly state that they were "flexible with the definition of P&B 

chemicals rather than ... using guidelines or threshold values". Thus, they did not use the internationally 

recognized criteria as the basis for their evaluations. In fact, it is unclear in several cases exactly what 

criteria were used making it difficult to determine how many of these chemicals have real PBT concerns. 

Also, over 60% of the chemicals identified using these flexible definitions were not reported in the most 

recent (2006) Inventory Update, indicating that they may not be in active commerce. Furthermore, they 

call for further study of these chemicals to determine if they are present in the environment especially 

in organisms in concentrations that could cause concern to determine if these "potential P&B 

chemicals" truly meet the criteria and concerns of the regulatory PBT programs. Although I do not 

believe it is appropriate to use this preliminary screening evaluation to draw a conclusion on the number 

of P&B chemicals in commerce, this publication demonstrates the valuable role of scientists in calling 

their colleagues to conduct the necessary research to identify those chemicals in commerce that are 

released to the environment and could cause adverse effects, thus would be of concern. This type of 

work needs to be supported so that confidence can be increased that the highest priority chemicals of 

concern have been identified and assessed. 

7. You testified we should have a "stronger Federal PBT program to build confidence so that States do 

not have to take separate and potentially conflicting actions." Please describe what you mean by a 

"stronger Federal PBT program" and whether tougher regulation alone is sufficient for a stronger 

Federal program. 
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A strong Federal PBT program would include 1) a Congressionally mandated TSCA priority setting, 

assessment and where necessary, management program for PBT chemicals, 2) strong technical expertise 

in screening and evaluation of PST chemicals in EPA at the Federal level, 3) development and 

promulgation of improved methods for identification and assessments, 4) training and assistance of 

state representatives, and 5) national coordination of PST chemical assessments and management 

actions. 

8. The Pellston workshop argues that the appearance of a PBT in the environment is not enough to 

warrant regulation, but rather, body or tissue residues showing a direct causal link to adverse 

responses are necessary to garner regulatory management. 

a. Please state whether you agree with that conclusion. 

b. Please state whether you believe body burden studies and the mere presence of a chemical in the 

body demonstrate a need for regulation, or whether they merely give us useful information on 

exposure. 

It is recognized in the scientific community that a chemical, whether it is a PST or not, cannot result in 

toxic or adverse effects on organisms unless it is incorporated into the body or tissue of the organism. 

There are lots of chemicals that are not taken up by organisms due to their physical and chemical 

properties. Thus, the presence of the chemical in the abiotic environment, e.g., soil, sediment, water, or 

air, does not indicate that the chemical is or could cause a significant adverse effect such that regulatory 

management is warranted. It is also important to recognize that the mere presence of a chemical in the 

body or tissue of an organism does not mean that an adverse effect is or will occur. The determination 

of the possibility of adverse effect must compare this body burden or tissue concentration to those 

concentrations found to cause adverse effects in controlled toxicity studies with appropriate margins of 

safety. This is equivalent, on the human health side, to the Center for Disease Control (CDC)'s 

statement that just because people have a chemical in their blood or urine does not mean that it will 

cause disease or have any adverse health effect because the mere presence of a chemical in the body or 

tissue of a human isn't enough to conclude that health effects are occurring. The CDC further 

emphasizes that additional research is required to determine whether the observed levels of a chemical 

may cause health effects and which levels are not significant health concerns 

9. Your testimony states that: "the U.S. EPA initially developed a list of PBT chemicals, wh ich was 

reduced to 28 organic chemicals and 3 metals based on comments and new information during public 

comment on the methodology." In addition, you mention that the European Chemicals Bureau 

identified an initial list of 127 substances, which was finally reduced to 24 substances. What is the 

difference between the methods and the final substances selected? 

The two programs are distinctly different in the program purpose, the starting list of chemicals 

screened, and the approach used. The US EPA list was developed under the RCRA program from a list of 

chemicals that could be present in wastes which included industrial chemicals, pesticides and waste 

products. These PBTs were identified based on a scoring method that included the properties of 

Persistence, Bioaccumulation and Toxicity that were informed by but were not strictly based on the PBT 
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criteria used in the new chemicals program. The scoring method also included some scores related to 

volume in waste based on TRI reporting and presence in the environment. Because of the focus on 

waste some of the chemicals identified on this list are waste products such as Dioxins/Furans and PAHs 

which are not intentionally produced chemicals. By contrast the European Chemicals Bureau program 

started with a list of the IUCLID HPV chemicals which are in commerce. In addition, it should be 

recognized that the criteria used by the European Chemicals Bureau are not the same as those used by 

the US EPA in their PBT screening. In fact, only those chemicals that meet the vPvB designation in the 

EU program could be considered to be equivalent to those meeting the P and B criteria in the US EPA's 

program. In both cases, public comment and additional data was brought forward to inform and 

improve the initial screening determinations and thus both final lists were better focused on chemicals 

with real PBT concerns. Because of the difference in the source list of chemicals that were initially 

chosen for PBT screening and the purposes of the programs, it is reasonable that there is little overlap in 

the final lists. Nevertheless, despite these differences in initial chemical list, purpose, criteria and 

method, when comparing the vPvB sublist of the ECB PBTs with the RCRA list there are 5 chemicals in 

common (i.e., anthracene, hexachlorobenzene, hexachlorobutadiene, gamma-hexachlorocyclohexane 

(Lindane) and Endosulfan). 

10. You testified, "Since 1999, PBT screening has been an integral part of EPA's New Chemical PMN 

review under TSCA to avoid approving new PBTs." Please state whether this is a good or bad thing 

and explain the basis of your conclusion. 

An important step to ensure that new PBT chemicals are not approved for commerce is to incorporate 

screening for PBT properties in the new chemical evaluation process. It was very proactive for US EPA to 

be one of the first countries in the world to explicitly incorporate this screening into their existing New 

Chemical PMN review and to do so in a transparent manner. This also reflects the leadership pOSition 

that the US was taking in the 1990's in the PBT identification process. It should be noted that such 

screening does not automatically prevent approval of the new chemical, PMN submitters are allowed to 

bring forward additional information and data to demonstrate that the chemical is not a PBT. 

11. U.S. EPA's existing screening efforts under TSCA's New Chemical PMN have been recognized as an 

extremely valuable contribution to the international community involved in PBT identification and 

assessments, from regulators to industry and to scientists. U.S. EPA has also been recognized 

internationally for its expertise in this area. 

a. Please state whether you agree with the consensus statement above. 

b. Please explain the basis of the international recognition referenced above. 

As mentioned in the response to the previous question, the US EPA was one of the first countries to 

publically announce and incorporate New Chemical screening for PBT characteristics into their PMN 

evaluations. The US EPA also made publically available the PBT Profiler tool that could be easily and 

transparently used within the global community to aid in chemical screening for PBT properties. This 

tool was built using components of the EPISuite QSAR tools and incorporated the expertise of US EPA 

scientists in how to extrapolate the results of these tools to inform PBT screening. The EPISuite QSAR 
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tool which was developed and has been continually improved by the US EPA, has been used for decades 

by governments' globally in chemical evaluations. The fact that both these tools have been used to 

inform initial screening for the Canadian DSL PBT categorization and the EU PBT assessments 

demonstrates the high regard held for the US EPA expertise. Another demonstration of the high regard 

internationally for US EPA expertise was the leadership role that US EPA took in assessing and taking 

action on perfluoro-chemicals (e.g., PFOS) which lead to subsequent assessment and action within the 

global community. 

12. You state: "Initially, in all these conventions, toxicity identification was determined by a risk 

based assessment called a risk profile but more recently a numeric criterion has also been 

incorporated in addition to the risk profile." Please clarify which Conventions employ this feature, 

including whether there is such numeric criteria for toxicity under the Stockholm Convention. Please 

state whether the risk profile from Annex D and E are the most important criteria, rather than a 

"toxicity criteria", because that is what is sent to the Conference of the Parties by the POPs Review 

Committee? 

To assist in the screening of chemicals for PBT properties, in some jurisdictions such as the Canadian DSL 

PBT screening and the US EPA New Chemical PMN review, toxicity criteria have been developed. These 

criteria are used to prioritize chemicals that meet the P and B criteria by identifying those substance that 

are most toxic as well as meeting P and B criteria. However, as in the Stockholm Convention, the final 

determination of whether the substance is a PBT and is causing significant adverse effects that warrant 

management action is determined by the risk profile. In any revision to the TSCA regarding PBT 

screening and assessment, the role of toxicity criteria as well as the P and B criteria should be limited to 

prioritizing substances and not serve as the basis for determining if the substance warrants immediate 

management action. This designation must result from a risk-based assessment. 

13. Does EPA's current approach have a "toxicity criteria"? What role do you think the numeric 

criterion has for screening vs. the risk profile? 

In addition to the P and B criteria, the New Chemical Program uses "toxicity criteria" in the evaluation of 

PBT characteristics. A chronic (long-term) toxicity value called a Fish ChV is used to estimate a 

chemical's relative toxicity. The toxicity criteria chosen are < 10 mg/I for TSCA Se Action, Significant New 

Use Rule (SNUR) Pending Testing and < 0.1 mg/I for TSCA 5e Action, Ban Pending Testing. Using such 

criteria for screening is important as it recognizes that if a chemical is not toxic (I.e., has a ChV > 10 mg/I) 

that it is unlikely to be causing a significant adverse effect on organisms and thus warrant regulatory 

action even if the P&B criteria are meet. Using toxicity criteria in addition to the P & B criteria in the 

screening assessment allows for prioritizing substances for further review and development of the risk 

profile to determine if regulatory management is needed for the chemical. 

14. During the hearing, there was a discussion about the need to create a list of PST chemicals. 

Please state whether it is more important to have a list of PST chemicals for regulation or a general 

direction for how U.S. EPA should screen, assess, and take action, if warranted, on these substances. 
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In several of the international conventions, lists of globally agreed PBT chemicals have been included 

after years of scientific discussion and international negotiation. In TSCA modernization the critical need 

is to have Congress direct EPA to establish a priority chemical program that includes prioritized PBTs. 

Congress should defer to EPA scientists on the development of such a list as well as the development of 

an effective and workable program that incorporates the most current science and scientific 

understanding for screening, evaluating and developing effective risk management, if warranted, of 

these types of substances. 
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Dr. William 1. Adams 

7760 North Boulder Drive 

Lake Point, UT 84074 

Dear Dr. Adams: 

March 23. 2010 

Thank you for before the Subcommittee ori COItmleree, Trade. and Consumer 

Protection on March 4, 2010, at the hearing entitled "TSCA and Persistent, Bioaccumulative. and 

Toxic Chemicals: Examining Domestic and International Actions," 

Pursuant to the Committee's Rules, attached arc written tor the record directed 

to you from certain Members oftlle Committee. In preparing your answers, address your 

response to the Member who submitted the questions, 

Please provide your responses by 9,2010, to Green, Chief Clerk, via e-mail 

Please contact Earley Green or Jennifer Berenholz at 

Sincerely. 

Chairman 

Attachment 
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The Honorable Joe Barton 

1. kf5. Greer testified that PBrs cannot be adequately assessed using risk assessment 

approaches. Please state whether you agree with this view. 

I \\Tould disagree with that statement recognizing that many succcssful risk assessments 

have been performed on dioxins, furans, PCBs, hexachlorobenzene and other PBT 

substances that have lead to remedial decision or evaluation of exposure levels. Perhaps 

Ms. Greer's statement is aimed at pointing out that risk assessment methods to date have 

resulted in few PBT substanccs being removed from the market place. In that regard, I 

would submit that it is not the fault of thc risk assessment methodology, but the manner 

in which the TSCA laws and regulations have been implemented. 

2. Please explain how disjointed PBr policy can afleet legal authorities under ReRA or 

other Federal environmental statutes. Please also explain how a disjointed PBr 

poliq can effect proper recycling and disposal efforts. 

EPA has long ranked recycling as more environmentally sound than disposal in its solid 

waste hierarchy. A disjointed PBT policy particularly one that inappropriately 

classifies metals as PBTs or seeks to use a PBT classification in lieu of risk asscssment 

approaches can impose higher burdens on management and recycling of used materials. 

resulting in their diversion to hazardous waste disposal facilities. This has adverse effects 

of two types: less recycling means (1) greater need for new materials (and primary 

mctals), and (2) incrcased reliance on costly and environmentally disfavored disposal 

alternatives. The consequences include not only higher costs, but a negative net 

envirorunental outcome. 

3. Mr. Sturdevant testified the government should make decisions about chemical 

substitutions and product replacement. You testified that industry. based on hazard 

and risk methodologies. begal1t%rmalize an approachfor selecting product 

substitutions in the 1960s. Please describe the lessons deril'edji'om the chemical 

substitution eOorts of the 1960s and J9 70s that make having the government in 

chmxe of these decisions a bad idea. 

The development of the PBT concept in the 1960s had its origin in assessing soap and 

detergent products that were causing foaming on may river systems in the US. This led 

to the development of safer alternative by industry without intervention. Products were 

developed that were less toxic and more biodegradable; LAS (linear alkylbenzene 

sulfonate ~ used in may soap products) is one such product. With the discovery of' both 

DDT and PCBs in the Great Lakcs, the PBT approach was used to look for alternative 

products. Use of DDT was bmmed (government action) and Monsanto Company 

voluntarily stopped product of PCBs and substituted more environmentally friendly 

products. Back at this time, DOW Chemical Company, Union Carbide, Proctor & 

Gamble, Monsanto and other were all using a PBT "like" approach to assess chemical 

hazard and to identify product with better environmental properties. These are examples 

where industry has made many decisions on what product to bring to the market. At 
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presnt the Johnson Company, RolU11 and Haas and other have intel11al programs that lead 

them in selection of "green" products. The negative side of government involvement has 

been that the PBT criteria are used in isolation from volume of product, product use and 

release rate. These factors are important in assessing whether or not a product presents 

risk . 

.t. Please explain why using "hazard-only" P BT criteria is an unscientific way to 

regulate PETs. Please also explain how crucial it is to include exposure criteria in 

this assessment. 

As indicated above, PBT criteria are often used in isolation from volume of product, and 

release rate. These factors are important in asscssing whether or not a product presents 

risk. Risk result from the combination of exposure of the substance to humans or wildlife 

and hazard (toxicity potential). Rate of release determines potential for exposure. 

Substances which are produced in small volumcs «1000 lbs). even though they may be 

highly toxic. rarely show up a significant environmental contaminants. Additionally, not 

considering exposure misses the fact normal environmental processes, such as hydrolysis, 

photo-oxidation, transformation and sorption to particles and scdiments may limit 

bioaccumulation and toxicity. 

5. Numerous witnesses I1m'e testified before this Committee regarding the negative 

aspects of the REACH proposal, but you testified Europe's regime appropriately 

treats metals. Please explain your conclusion. 

The procedures used to assess the metals under REACH were developed in cooperation 

w'ith the European Commission. The metals industry began to work with the European 

Commission 5 years before the regulation went into etTect. The copper and lead industry 

agreed to complete a voluntary risk assessment for all uses of all products following the 

spirit of the REACG regulations. The cadmium, nickel and zinc industry also performed 

similar risk assessments, but these were done at the request of the Commission. The 

information gained from these extensive risk assessments ",'ere used to help shape the 

REACH regulations. These 5 industries spent some $35M in collecting information on 

the toxicity of their respective metal substances to evaluate effects on human health, 

aquatic life, soil organisms and multiple wildlife species. Additionally data were gathered 

on water, air, soil and sediment concentrations across Europe as part of the exposure 

assessment. Having expanded such an enormous effort across 5-6 years, extensive data 

sets now exist on these metal substances and their uses. While the exposure assessment 

in Europe may not be appropriate for the United States, clearly the toxicological data sets 

are applicable and useful. The metals industries see no reason why this vast array of 

knowledge could not be used across regulatory jurisdictions. 

6. Please explain 11'hether. in your opinion, "hard-and:fast" PBT criteria ignore the 

scientific nuances ofthese chemicals. including ho'w they react in the environment 

based upon climate. hydrology, and other/actors, Please state whether you believe 

using "hard-and:fast" PET criteria could result in scientifically unsupportable or 
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imperfect regulatory decision-making. 

My comments on PBT were specifically aimed at the application of the PBT criteria to 

metal substances. i.c .• inorganic compounds. In my following comments I explain why 

they are not applicable to metals and inorganic metallic substance. I realize my answer is 

narrowing the field to inorganic substances. but this was the focus on my testimony. 

"Hard and Fase PBT criteria for metals will not \\iork as the PBT criteria were designed 

for substances with a carbon base. 

7. Please describe the dU!erence betlreen a Persistent Organic Pollutant and a chemical 

thai is persistem. bio-acculIlulatire, and toxic. Please explainll'hether this difference 

is important. 

If you translate the words persistent organic pollutant in the strict sense then it only 

covers substances that have a carbon base and do not biodegrade. The term persistent 

organic pollutant (POP) was coined to differentiate chemicals with a carbon (C» base 

from inorganic / metallic substances. Substances that are commonly listed as POPs under 

the POPs treaty are also PBT substances. Considering the chemicals listed as POPs 

under the POPS treaty there is no difference that is significant. 

8. Please explain your assertion that it is both significant and problematic to use PET 

criteria to identit)· contaminants of concern. (/nd to inlroduce restrictions Oil commerce. 

trampo/'talion, and labeling based upon these criteria. 

My statement in this regard was aimed at inorganic substances (non-carbon based 

substances such as metals). The measurcs of persistence and bioaccumulation that have 

been developed to date have bcen developed for organic carbon based substances. They 

are not appropriate descriptors of the properties of metals, While bioaccumulation 

factors (B) for organic substances are independent of concentration and hence. useful 

across a widc range of environments. the same is not true for metals (inorganic 

substances). Bioaccumulation factors for metals arc in fact inversely related to 

concentration. As a consequence the metal bioaccumulation factors for the cleanest 

environments are larger than those for contaminated cnvironmcnts. As a result they 

predict clean environments to be a problem. This is counter intuitive. Likewise for the 

•. p" this docs not work for mctals. Persistence for organic compounds is considcred bad. 

but for metals and inorganic substances. persistence is absolutely critical. Thcse 

substances must be persistence to sustain life. All elements on the periodic table arc 

persistent. Our universc is built on this principal. Hence. my statement follows that PBT 

approaches should never be applicd to metals and inorganic substanee. This is 

recognized in the USEI' A Metals Framework Risk Asscssment document and is 

recognized in the European Union regulations pertaining to REACH. 

If PBT criteria are use to rcgulate inorganic substances including metals this is indeed 

problematic and not in agreement with science based facts. 
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9. rOll testified "individual criteria are limited in their ability to assess hazard or to 

prioritize metal substances" because they are l10tlinked or integrated. In addition. 

you testified that P BT criteria altempt to idenii/jJ or predict hazards using certain 

modifiers withoutfully incorporating other important/ate characteristics. Please 

explail111'hy this is important. 

My comments prior to question No.9 were focused on metals and inorganic substances. 

For this question my response is applicable to both metals and inorganic substances. The 

P - B - T criteria are independent of eaeh other. Thresholds are set for eaeh of the three 

criteria. The substance either meets the criteria or not. The scientifIC community has 

recognized that to properly assess the risk of substances one has to assess the integration 

of persistence (degradation) with potential for accumulation and toxicity after 

environmental factors have occun-ed that may alter exposure. Bioaccumulation does not 

occur independent of cxposure concentration. neither does toxicity. Hence. an integrated 

approach is required to have a full understanding of the potential for effects. The PBT 

approach comes out of the late 19605 and 19705. We now have much better computing 

ability and we recognize we need to assess the bioavailability of the test substance to 

organisms and there is a need to integrate loss of substance from the water column 

(Persistence) with reduced bioaecumulation (B) and resulting potential for inherent 

toxicity (T). Consequently. we have developed model to integrate these three parameters 

in a way that mimics natnral lake systems. This model is entitled the Unit World Model 

and is available at ~"\n\'J..!Ilillyorldmodel.n~!. Details on this integrated approach can be 

found in a book published by the Society of Environmental Toxicology and Chemistry 

(SETAC). 

Adams W.J. Chapman PM. 2005. Assessing the Hazard of Metals and Inorganic 

Metal Slibstances in Aquatic and Terrestrial S)ostem.\': SU!1lm(1l)' of a SETAe 

Pellston Workshop. Pensacola (FL). SETAC Press. Pensacola, FC USA. 

o