S. HRG. 115–410 

OVERSIGHT OF THE ENVIRONMENTAL PROTECTION AGENCY’S IMPLEMENTATION OF SOUND 

AND TRANSPARENT SCIENCE IN REGULATION 

HEARING 

BEFORE THE

SUBCOMMITTEE ON SUPERFUND, WASTE 

MANAGEMENT, AND REGULATORY OVERSIGHT 

OF THE

COMMITTEE ON 

ENVIRONMENT AND PUBLIC WORKS 

UNITED STATES SENATE 

ONE HUNDRED FIFTEENTH CONGRESS 

SECOND SESSION 

OCTOBER 3, 2018 

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

( 

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

OVERSIGHT OF THE ENVIRONMENTAL PROTECTION AGENCY’S IMPLEMENTATION OF SOUND AND TRANSPARENT SCIENCE 

IN REGULATION 

U.S. GOVERNMENT PUBLISHING OFFICE

33–371 PDF WASHINGTON : 2018

S. HRG. 115–410 

OVERSIGHT OF THE ENVIRONMENTAL PROTECTION AGENCY’S IMPLEMENTATION OF SOUND 

AND TRANSPARENT SCIENCE IN REGULATION 

HEARING 

BEFORE THE

SUBCOMMITTEE ON SUPERFUND, WASTE 

MANAGEMENT, AND REGULATORY OVERSIGHT 

OF THE

COMMITTEE ON 

ENVIRONMENT AND PUBLIC WORKS 

UNITED STATES SENATE 

ONE HUNDRED FIFTEENTH CONGRESS 

SECOND SESSION 

OCTOBER 3, 2018 

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

( 

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

(II) 

COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS 

ONE HUNDRED FIFTEENTH CONGRESS 

SECOND SESSION 

JOHN BARRASSO, Wyoming, Chairman 

JAMES M. INHOFE, Oklahoma 

SHELLEY MOORE CAPITO, West Virginia 

JOHN BOOZMAN, Arkansas 

ROGER WICKER, Mississippi 

DEB FISCHER, Nebraska 

JERRY MORAN, Kansas 

MIKE ROUNDS, South Dakota 

JONI ERNST, Iowa 

DAN SULLIVAN, Alaska 

RICHARD SHELBY, Alabama 

THOMAS R. CARPER, Delaware, 

Ranking Member 

BENJAMIN L. CARDIN, Maryland 

BERNARD SANDERS, Vermont 

SHELDON WHITEHOUSE, Rhode Island 

JEFF MERKLEY, Oregon 

KIRSTEN GILLIBRAND, New York 

CORY A. BOOKER, New Jersey 

EDWARD J. MARKEY, Massachusetts 

TAMMY DUCKWORTH, Illinois 

CHRIS VAN HOLLEN, Maryland 

RICHARD M. RUSSELL, Majority Staff Director 

MARY FRANCES REPKO, Minority Staff Director 

SUBCOMMITTEE ON SUPERFUND, WASTE MANAGEMENT, 

AND REGULATORY OVERSIGHT

MIKE ROUNDS, South Dakota, Chairman 

JERRY MORAN, Kansas 

JONI ERNST, Iowa 

DAN SULLIVAN, Alaska 

JOHN BARRASSO, Wyoming (ex officio) 

CORY A. BOOKER, New Jersey, 

Ranking Member 

BERNARD SANDERS, Vermont 

CHRIS VAN HOLLEN, Maryland 

THOMAS R. CARPER, Delaware (ex officio) 

(III) 

C O N T E N T S 

Page 

OCTOBER 3, 2018 

OPENING STATEMENTS 

Rounds, Hon. Mike, U.S. Senator from the State of South Dakota .................... 1 

Booker, Hon. Cory A., U.S. Senator from the State of New Jersey ..................... 3 

WITNESSES 

Calabrese, Edward J., Professor, University of Massachusetts at Amherst 

School of Public Health and Health Sciences .................................................... 5 

Prepared statement .......................................................................................... 8 

Responses to additional questions from: 

Senator Markey ......................................................................................... 15 

Senator Sanders ........................................................................................ 18 

Hahn, Robert, Visiting Professor, Oxford University Smith School of Enterprise and the Environment ................................................................................. 20 

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

Responses to additional questions from Senator Sanders ............................. 29 

Holt, Rush D., Chief Executive Officer, American Association for the Advancement of Science ..................................................................................................... 31 

Prepared statement .......................................................................................... 33 

Responses to additional questions from Senator Markey ............................. 38 

ADDITIONAL MATERIAL 

Case-Control Study of Lung Cancer Risk From Residential Radon Exposure 

in Worcester County, Massachusetts. Richard E. Thompson et al., Health 

Physics Society. Manuscript accepted August 29, 2007 .................................... 379 

National Stone, Sand & Gravel Association, Statement for the Record, October 3, 2018 ............................................................................................................ 393 

(1) 

OVERSIGHT OF THE ENVIRONMENTAL PROTECTION AGENCY’S IMPLEMENTATION OF 

SOUND AND TRANSPARENT SCIENCE IN 

REGULATION 

WEDNESDAY, OCTOBER 3, 2018 

U.S. SENATE, 

COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS, 

SUBCOMMITTEE ON SUPERFUND, WASTE MANAGEMENT, 

AND REGULATORY OVERSIGHT, 

Washington, DC. 

The Committee met, pursuant to notice, at 2:20 p.m. in room 

406, Dirksen Senate Office Building, Hon. Mike Rounds (Chairman 

of the Subcommittee) presiding. 

Present: Senators Rounds, Booker, Barrasso, Carper, Ernst, Sullivan, Whitehouse, and Van Hollen. 

OPENING STATEMENT OF HON. MIKE ROUNDS, 

U.S. SENATOR FROM THE STATE OF SOUTH DAKOTA 

Senator ROUNDS. Good afternoon, everyone. 

The Environment and Public Works Subcommittee on Superfund, 

Waste Management, and Regulatory Oversight is meeting today to 

conduct a hearing entitled Oversight of the Environmental Protection Agency’s Implementation of Sound and Transparent Science in 

Regulation. 

Today we will hear testimony from experts and members of the 

scientific community in order to explore opportunities for greater 

transparency and the use of the best available science at the EPA. 

Regulations created by the EPA help to protect the American people from tainted water, dirty air, and chemical exposure. The essential work completed by the EPA should always have as its basis 

protecting human health and the environment. 

However, in the past, I have been concerned that the broad discretion and lack of transparency at the EPA has led the Agency to 

seek out the science that supports a predetermined policy outcome 

rather than relying upon the best available science before coming 

to conclusions. Failing to do so results in regulations that overly 

burden our economy without having a substantial impact on 

human health or environmental protection. 

On April 30th, 2018, the EPA published a proposed rule entitled 

‘‘Strengthening Transparency in Regulatory Science.’’ This proposed rule would require the EPA to identify what science they 

used to come to regulatory decisions and to make those studies 

available to the public without compromising privacy protections. 

2 

The proposed rule would also require the EPA to take into account high quality studies that challenge current scientific assumptions. The proposal seeks to accomplish this without excluding historically relied upon studies by allowing the EPA Administrator to 

waive certain data access requirements on a case by case basis. 

I thank the EPA for taking this important step, and I look forward to hearing from our witnesses today about the proposed rule. 

In addition, on September 12th, 2017, I introduced S. 1794, the 

Honest and Open New EPA Science Treatment Act, commonly referred to as the HONEST Act. Companion legislation, H.R. 1430, 

was also introduced by Representative Lamar Smith. The HONEST 

Act passed the House of Representatives with bipartisan support 

on March 29th, 2017. Both bills have been referred to the Senate 

Committee on Environment and Public Works. 

The HONEST Act would prohibit the EPA from proposing, finalizing, or disseminating regulations or guidance unless all scientific 

and technical information relied on to support those actions is 

based on the best available science. The bill also requires this information to be specifically identified and publicly available in a 

manner sufficient for independent analysis and substantial reproduction of research results. Finally, the HONEST Act requires the 

EPA to redact sensitive information such as personally identifiable 

information, trade secrets, or commercial or financial information. 

It has been suggested by some that the EPA is incapable of providing greater scientific transparency because of privacy concerns. 

We have a responsibility to be sensitive to that issue, in part because we do not want to dissuade individuals from participating in 

environmental studies. 

I believe the EPA should use, as a model, the privacy protections 

already used by other Federal agencies, including the de-identification protocols employed by the Department of Health and Human 

Services. 

The EPA has a long history of creating burdensome, unnecessary 

regulations without giving the public an opportunity to fully vet 

the reasoning behind their decisions. We should all agree with providing greater transparency if it can be done without excluding legitimate scientific studies or compromising privacy. This is especially true if we can turn to other agencies, like the National Institutes of Health, for guidance on best practices. 

Sound, reliable science is vital to helping us make important policy decisions that impact not just the health of American families, 

but their livelihoods. We should welcome vigorous debate on the 

science the EPA relies upon. Doing so will result in regulations 

that have the greatest benefit to human health and the environment, while doing the least harm to the economy. It will also result 

in regulations that can withstand legal challenges, providing industry with a level of certainty that allows them to make long-term 

investment decisions. 

I would like to thank our witnesses for being here with us today, 

and I look forward to hearing your testimony. 

At this time, I would like to recognize Senator Booker for a 5- 

minute opening statement. 

Senator Booker. 

3 

OPENING STATEMENT OF HON. CORY A. BOOKER, 

U.S. SENATOR FROM THE STATE OF NEW JERSEY 

Senator BOOKER. Mr. Chairman, I am really grateful. Thank you 

for this opportunity and for calling the hearing. 

I just want to give a quick opening statement and will submit 

a lot more of my remarks for the record. 

One thing the Chairman and I agree with is how important it is 

for our regulatory agencies, including the EPA, to use the best 

available science to inform their decisionmaking. That is why so 

many of their Federal environmental laws include a best available 

science requirement, including TSCA, something that all of us 

worked well together on, which members of this Committee spent 

lots of time working on and came to an incredible bipartisan consensus on. 

I think we can also agree that transparency in agency decisionmaking is very important. So, I am glad to have the chance to have 

a discussion about the need for transparent, science based decisionmaking at the EPA. 

Unfortunately, the policy proposals that are the subject of today’s 

hearing include the EPA’s proposed rule to purportedly strengthen 

transparency and regulatory science. This rule is far more likely to 

hinder science based regulation than help it. In fact, the EPA did 

not even consult with its own scientific advisory board, which is 

charged with determining whether the best available science is 

being used as a basis for EPA regulatory actions, regarding this 

public rule. Instead, it has chosen to ignore fundamental concerns 

raised by its own advisory board members. 

I believe that the proposed rule put forth by the EPA and the 

legislation called the HONEST Act actually conflicts with the 

EPA’s directive to use the best available science. Examples of this 

are common sense. If the EPA could not consider scientific studies 

unless the underlying data is made publicly available in a way that 

is sufficient for validation, the Agency would not be able to consider 

science gathered in the aftermath of environmental disasters, such 

as the Deepwater Horizon oil spill, which is not a scientifically 

replicable event. 

The Agency would not be able to consider studies that rely on 

private medical information or confidential business information 

because that data could not be made publicly available. Obviously, 

it would be unethical for anyone to attempt to replicate public 

health analyses that used data gathered from different exposures 

to certain populations and communities, exposures to lead, to 

PCBs, to mercury, or other chemical contaminants. We would not 

want anybody to replicate those studies and that suffering. 

For example, the EPA bases its standards for lead based paint 

hazards on long-term studies of children who were exposed to lead. 

Prohibiting the EPA from using these historical studies would cripple its ability to protect children and other vulnerable populations 

from lead, as one example. 

I am looking forward to this afternoon’s conversation, but I want 

to emphasize that if the EPA was truly concerned about transparency, there are actually meaningful actions the EPA could be 

immediately taking. 

4 

First, the EPA could release to the public the report that EPA 

completed more than 1 year ago regarding the cancer risks of formaldehyde, something we still have not released. Where is the transparency there? 

Second, the EPA could convene an independent science advisory 

panel to recommend best practices for ensuring transparency in developing public health and environmental regulations, not ignore 

their own science based advisory board. 

Finally, the EPA could immediately withdraw its May 2018 proposed rule to modify the Risk Management Program amendments 

where EPA is now proposing to restrict the public’s access to information about what chemicals are being stored in facilities in their 

communities and neighborhoods. The public has a right to know 

about dangerous chemicals. Why is the EPA withholding that information from them? 

So, I look forward to hearing from our witnesses. I will put more 

information for the record, but I again want to thank my colleague 

and friend for calling this important hearing having this discussion. 

Senator ROUNDS. Thank you, Senator Booker. 

Our witnesses joining us for today’s hearing are Dr. Edward 

Calabrese, Professor, University of Massachusetts at Amherst 

School of Public Health and Health Sciences; Robert Hahn, Visiting 

Professor, Oxford University Smith School of Enterprise and the 

Environment; and Dr. Rush Holt, Chief Executive Officer, American Association for the Advancement of Science. 

Welcome to all of you. 

I would like to also, at this time, yield to Senator Booker to introduce Dr. Holt. 

Senator BOOKER. I could not let this moment go, Chairman, without trying to make Dr. Holt blush a little bit, because he is nothing 

short of a New Jersey treasure. He served eight terms in the House 

of Representatives and was the Congress’s only legitimate rocket 

scientist who was in Congress. He has had an extraordinary career 

of public service even beyond his eight terms as a House member. 

Right now, he is a publisher of Science Family of Journals. In 

this role, Dr. Holt leads the largest multidisciplinary scientific and 

engineering membership organization. Prior to joining AAAS, Dr. 

Holt was not only a Congressperson, but he was probably one of 

the best well known leaders in his State of New Jersey because he 

was the most nerd-chic guy in our State. 

Dr. Holt has been named one of Scientific American magazine’s 

50 national visionaries contributing to a brighter technological future and a champion of science by the Science Coalition. From 1989 

to 1998 Dr. Holt was Assistant Director of the Princeton Plasma 

Physics Laboratory, and he previously taught physics and public 

policy at Swarthmore College. 

And I just want to get rid of the rumor. In the TV show The Big 

Bang Theory, Sheldon’s character was not based on Dr. Holt. 

[Laughter.] 

Senator VAN HOLLEN. Mr. Chairman, if I could just briefly add 

to that. 

I want to welcome all the witnesses, but it is good to see my 

friend, Rush Holt. We served together for many years in the House, 

5 

and everything that the Ranking Member said is 100 percent true, 

but he left out a very important fact, which I believe you are the 

only Member of Congress who won Jeopardy or was a finalist on 

Jeopardy, as well. 

I apologize because I am going to have to leave, and I am going 

to try and come back, but I appreciate the opportunity. Thanks. 

Senator ROUNDS. Thank you. 

Once again, thank you, Senator Booker. 

Thank you to all of our witnesses for taking the time to participate today; we most certainly appreciate it. 

We will now turn to our first witness, Dr. Calabrese, for 5 minutes. 

I would share with you all your opening statements will all be 

included, without objection, for the record. We would ask if you 

could try to limit your opening remarks to about 5 minutes; that 

would be greatly appreciated by the Committee as well. 

Dr. Calabrese, welcome, and you may begin. 

STATEMENT OF EDWARD J. CALABRESE, PROFESSOR, UNIVERSITY OF MASSACHUSETTS AT AMHERST SCHOOL OF 

PUBLIC HEALTH AND HEALTH SCIENCES 

Mr. CALABRESE. Thank you very much. 

Good afternoon, Chairman Rounds, Ranking Member Booker, 

and distinguished members of the Committee. My name is Edward 

Calabrese, and I am a Professor of Toxicology at the University of 

Massachusetts School of Public Health, Amherst, Mass. I am 

pleased to share with you my views on the EPA risk assessment 

transparency proposal. 

Briefly, I have been at UMass for 42 years, teaching and researching in the areas of toxicology and risk assessment. I have authored nearly 900 papers in the peer reviewed literature, about a 

dozen books, served on multiple National Academy committees 

such as the Safe Drinking Water Committee and the Air Cabin 

Safety Committee, which recommended to the FAA to eliminate 

smoking on commercial aircraft, a recommendation that was quickly adopted. 

For the past 20 years, I have been funded by the Air Force Office 

of Scientific Research to assess the nature of the dose response of 

toxic substances in the low dose zone in order to protect the health 

and the well-being of Air Force personnel. These activities have led 

to a major dose response revolution in the area of biology, medicine, toxicology, and risk assessment. 

The USEPA has proposed a general framework to strengthen its 

regulatory science procedures via enhancing transparency in multiple ways. I applaud EPA for this proposal as it is not only timely 

but requires scientific and administrative accountability. The proposal is broad, requiring the Agency to provide the scientific basis 

for proposed regulations, including underlying data. While this is 

an excellent start, the Agency should also commit to providing detailed explanations and public access to data that the Agency considered and decided not to use for regulation. 

In addition, most EPA scientific decisions are based on multiple 

assumptions, some of which are frequently hidden, obscured, and 

often silent drivers of regulatory action; for example, the use of 

6 

highly susceptible and often poorly predictive animal models. These 

assumptions need to be fully described, documented, and justified. 

This process should also include the basis for why EPA chose not 

to adopt the use of other or different approaches and/or assumptions. Thus, EPA’s transparency proposal is excellent as far as it 

goes, but it needs to be expanded; it also requires an explanation 

of what was considered, and why it was rejected. 

Multiple high profile controversies exist over the lack of availability of data sets used by EPA for regulatory decisions. While I 

have not been involved in Agency disputes over such data bases, 

I would like to note two personal examples that speak to data sharing with EPA and the scientific community, and the value offered 

to the Agency and the public. For example, in the 1980s I developed a data base of 6,000 dose responses concerning whether carcinogens could cause cancer with but a single dose. I made many 

presentations on this topic across the country, including several 

NAS Committees concerned with acute/short term exposures to 

toxic and carcinogenic agents in the aftermath of the 1984 Bhopal, 

India, disaster. Following these presentations, EPA asked me to 

provide it with a copy of the single exposure carcinogen data base. 

These presentations and the shared data base were intended to assist the NAS in guidance to EPA. 

Second, my group at the University of Massachusetts conducted 

multiple studies on soil ingestion in children and adults. Subsequently, EPA used these data for clean up standards of soil and 

dust contamination for the benefit of children and adults. Our 

group created a public Web site with all our data available for use 

by the EPA and the world, minus personal identifiers. 

These are examples to enhance improved science and transparency in regulatory activities. The EPA transparency proposal is 

crucial to enhance public health and should have been adopted in 

some form 20 or more years ago. 

With regards to risk assessment, ‘‘data transparency’’ should require the EPA to routinely receive and openly evaluate for accuracy 

any information that could significantly alter the key scientific assumptions underlying and dictating regulatory policy and practices. 

This current EPA proposal does just that by stating that EPA 

should no longer use the LNT, or linear non-threshold, model as 

the default in risk assessment. 

Movement away from LNT as the accepted default model is long 

overdue. It is compellingly supported by many peer reviewed scientific and historical studies and is badly needed to advance toward a more science based approach in assessments of human and 

ecological risks. 

Within this context, I have researched the nature of the dose response in the low dose zone for more than 30 years and have published about 500 papers on this topic in peer reviewed journals. I 

have organized and conducted international conferences on the 

topic for over 25 years and have created a professional journal 

called Dose Response, for which I am the editor in chief. I have also 

written chapters on dose response for some of the major textbooks. 

More recently, in the past decade I have exhaustively researched 

the historical origins and scientific foundations of EPA’s LNT 

model and have found it sorely wanting. LNT is important because 

7 

it is the model upon which all our cancer risk assessments and key 

health and ecological regulations are based. What I have learned 

was unexpected, and it has turned more than 30 years of my understanding of toxicology upside down. It has revealed that what 

I taught for so many years at UMass and have written about so 

ardently in my many articles and books was factually wrong. What 

I learned in this reevaluation of LNT was that the field of toxicology and our regulatory agencies, such as EPA, had made a serious error in their understanding of LNT and incorrectly applied it 

to the assessment of human and ecological risks. 

During my research and publication over a dozen peer reviewed 

journal articles on the scientific origins of LNT, I learned that the 

LNT dose response model which drives cancer risk assessment was 

based on flawed science, on ideological biases by leading radiation 

geneticists, on scientific misconduct by National Academy of 

Sciences genetics panel during the atomic radiation scares of the 

1950s, and on a 40-year mistaken assumption by yet another NAS 

committee. 

I learned that these flaws, biases, misconducts, and mistakes ultimately gave rise to the EPA model and were perpetuated down 

to the present day by subsequent committees of the NAS and EPA. 

What began for me as a routine academic exercise to affirm the scientific origins and credibility of LNT ironically ended as a remarkable repudiation of its scientific adequacy, challenging both the old 

guard and an EPA risk assessment process that is in need of significant revision. 

My findings show that the EPA adopted LNT for all the wrong 

reasons and built their flawed risk assessment edifice upon it, failing to perform due diligence expected by Congress and the public. 

Senator ROUNDS. If I could ask you to perhaps wrap it up. Everything will be included in the record. 

Mr. CALABRESE. It is one paragraph more, Senator. 

Senator ROUNDS. Yes. Go ahead. 

Mr. CALABRESE. Second, extensive research findings that contradict EPA’s LNT model have now been documented in the scientific literature. 

With so many failed LNT predictions, EPA must not continue to 

use LNT as its default. A crusading EPA was young, impressionable, inexperienced, and somewhat blinded, and it adopted the 

flawed LNT model, believing that it would save the world. Not only 

was it wrong scientifically; the LNT in many ways has damaged 

public health and the economy, the worst of both worlds. 

The present EPA proposal to consider non-linear models for risk 

assessment is a critical, positive development. Thus, I believe that 

the EPA has made a bold and constructive proposal that is scientifically sound and should be strongly supported, approved, and implemented. 

Thank you very much. 

[The prepared statement of Mr. Calabrese follows:] 

8 


33371.001

Dr. Edward J. Calabrese 

Professor of Toxicology 

University of Massachusetts, Amherst 

Edward J. Calabrese is a Professor of Toxicology at the University 

of Massachusetts, School of Public Health and Health Sciences, 

Amherst. Dr. Calabrese has researched extensively in the area of 

host factors affecting susceptibility to pollutants, and is the author of 

over 850 papers in scholarly journals, as well as more than 10 

books, including Principles of Animal Extrapolation; Nutrition and 

Environmental Health, Vols. I and II; Ecogenetics; Multiple Chemical Interaction; Air 

Taxies and Risk Assessment; and Biological Effects of Low Level Exposures to 

Chemical and Radiation. Along with Mark Mattson (NIH) he is a co-editor of the 

recently published book entitled Hormesis: A Revolution in Biology, Toxicology and 

Medicine. He has been a member of the U.S. National Academy of Sciences and 

NATO Countries Safe Drinking Water committees, and on the Board of Scientific 

Counselors for the Agency for Toxic Substances and Disease Registry (ATSDR). Dr. 

Calabrese also serves as Chairman of the Biological Effects of Low Level Exposures 

(BELLE) and as Director of the Northeast Regional Environmental Public Health Center 

at the University of Massachusetts. Dr. Calabrese was awarded the 2009 Marie Curie 

Prize for his body of work on hormesis. He was the recipient of the International Society 

for Cell Communication and Signaling-Springer award for 2010. He was awarded an 

Honorary Doctor of Science Degree from McMaster University in 2013. In 2014 he was 

awarded the Petr Beckmann Award from Doctors for Disaster Preparedness. 

Over the past 25 years Professor Calabrese has redirected his research to 

understanding the nature of the dose response in the low dose zone and underlying 

adaptive explanatory mechanisms. Of particular note is that this research has led to 

important discoveries which indicate that the most fundamental dose response in 

toxicology and pharmacology is the hormetic-biphasic dose response relationship. 

These observations are leading to a major transformation in improving drug discovery, 

development, and in the efficiency of the clinical trial, as well as the scientific 

foundations for risk assessment and environmental regulation for radiation and 

chemicals. 
9 


33371.002

October 3, 2018 

Testimony of Edward J. Calabrese, Ph.D 

Senate Environment and Public Works Subcommittee on Superfund, Waste Management 

and Regulatory Oversight 

"Oversight of the Environmental Protection Agency's Implementation of Sound and 

Transparent Science in Regulation" 

Good afternoon, Chairman Rounds, Ranking Member Booker, and 

distinguished members of the Committee. My name is Edward Calabrese, and I am 

a professor of toxicology at the University of Massachusetts, School of Public 

Health Sciences, Amherst, Massachusetts. I am pleased to share with you my 

views on the EPA Risk Assessment Transparency Proposal. 

Briefly, I have been at UMass for 42 years, teaching and researching in the 

areas of toxicology and risk assessment. I have authored nearly 900 papers in the 

peer-reviewed literature, about a dozen books, served on multiple National 

Academy of Sciences (NAS) committees such as the Safe Drinking Water 

Committee and the Air Cabin Safety Committee, which recommended to the FAA 

to eliminate smoking on commercial aircraft, a recommendation that was quickly 

adopted. For the past 20 years I have been funded by the Air Force Office of 

Scientific Research to assess the nature of the dose response oftoxic substances in 

the low dose zone in order to protect the health and wellbeing of Air Force 
10 


33371.003

personnel. These activities have lead to a major dose-response revolution in 

biology, medicine, toxicology and risk assessment. 

The U.S. EPA has proposed a general framework to strengthen its regulatory 

science procedures via enhancing transparency in multiple ways. I applaud EPA 

for this proposal as it is not only timely but requires scientific and administrative 

accountability. The proposal is broad, requiring that the Agency provide the 

scientific basis for proposed regulations, including underlying data. While this is 

an excellent start, the Agency should also commit to providing detailed 

explanations and public access to data that the Agency considered and decided not 

to use for regulation. In addition, most EPA scientific decisions are based on 

multiple assumptions, some of which are frequently hidden, obscured and often 

silent drivers of regulatory action. (e.g., the usc ofhighly susceptible and often 

poorly predictive animal models). These assumptions need to be fully described, 

documented, and justified. This process should also include the basis for why EPA 

chose not to adopt the use of other/different approaches and/or assumptions. Thus, 

EPA's transparency proposal is excellent as far as it goes, but it needs to be 

expanded; it also requires explanation of what was considered and why it was 

rejected. 

Multiple high profile controversies exist over the lack of availability of key 

data sets used by the EPA for regulatory decisions. While I have not been involved 

2 
11 


33371.004

in Agency disputes over such databases, I would like to note two personal 

examples that speak to data sharing with EPA and the scientific community and the 

value offered to the Agency and the public. In the 1980s I developed a database of 

6,000 dose responses concerning whether carcinogens could cause cancer with but 

a single dose. I made many presentations on this topic across the country, including 

several to NAS Committees concerned with acute/short term exposures to toxic 

and carcinogenic agents in the afternmth of the 1984 Bhopal, India disaster. 

Following these presentations, EPA asked me to provide it with a copy of the 

single-exposure carcinogen database. These presentations and the shared database 

were intended to assist the NAS in guidance to EPA. Second, my group at the 

University of Massachusetts conducted multiple studies on soil ingestion in 

children and adults. EPA subsequently used these data for clean-up standards of 

soil/dust contamination for the benefit of children and adults. Our group created a 

public website with all our data available for use by the EPA and the world. These 

are examples to enhance improved science and transparency in regulatory 

activities. The EPA transparency proposal is crucial to enhance public health and 

should have been adopted 20 or more years ago. 

With regard to risk assessment, "data transparency" should require the EPA to 

routinely receive and openly evaluate for accuracy any information that could 

significantly alter the key scientific assumptions underlying and dictating 

3 
12 


33371.005

regulatory policy and practices. This current EPA proposal does just that by stating 

that the EPA should no longer usc the LNT (linear non-threshold) model as the 

default model in risk assessment. Movement away from LNT as the accepted 

default model is long overdue. It is compellingly supported by many peer-reviewed 

scientific and historical studies, and it is badly needed to advance toward a more 

science-based approach in the assessments of human and ecological risks. 

Within this context I have researched the nature of the dose response in the 

low-dose zone for more than 30 years and have published< about 500 articles on this 

topic in peer-reviewed journals. I have organized and conducted international 

conferences on the topic for over 25 years and created a professional journal called 

Dose Response, for which I am the editor in chief. I have also written chapters on 

dose response for some ofthe major toxicology textbooks. More recently in the 

past decade, I have exhaustively researched the historical origins and scientific 

foundations ofthe EPA's LNT model and have found it sorely wanting. LNT is 

important because it is the model upon which all our cancer risk assessments and 

key health and ecological regulations are based. What I have learned was 

unexpected and has turned more than 30 years of my understanding of toxicology 

upside down. It has revealed that what I had taught for so many years at UMass 

and had written about so ardently in my many articles and books was factually 

wrong. What I learned in this re-evaluation ofLNT was that the field of 

4 
13 


33371.006

toxicology and our regulatory agencies, such as EPA, had made a serious error in 

their understanding ofLNT and incorrectly applied it to the assessment of human 

and ecological risks. 

During my research and publication of over a dozen peer-reviewed journal 

articles on the scientific origins ofthe LNT, I learned that the LNT dose-response 

model, which drives cancer risk assessment, was based on flawed science, on 

ideological biases by leading radiation geneticists, on scientific misconduct by an 

NAS Genetics Panel during the atomic radiation scares ofthel950's, and on a 40-

ycar mistaken assumption by yet another NAS Committee. I learned that these 

flaws, biases, misconducts and mistakes ultimately gave rise to the LNT model and 

were perpetuated down to the present day by subsequent Committees of the NAS 

and the EPA. What began for me as a routine academic exercise to a11irm the 

scientific origins and credibility ofLNT ironically ended as a remarkable 

repudiation of its scientific adequacy, challenging both the old guard and an EPA 

cancer-risk assessment process that is in need of significant revision. 

My findings show that the EPA adopted the LNT for all the wrong reasons 

and built their flawed risk assessment edifice upon it-failing to perform the due 

diligence expected by Congress and the public. Secondly, extensive research 

findings that contradict the EPA's LNT model have now been documented in the 

scientific literature. With so many failed LNT predictions, EPA must not continue 

5 
14 


33371.007

to use the LNT model as its default. A crusading EPA that was young, 

impressionable, inexperienced and somewhat blinded adopted the flawed LNT 

model-believing it would save the world. Not only was it wrong scientifically, 

the LNT in many ways has damaged public health and the economy-the worst of 

both worlds. The present EPA proposal to consider non-linear models for risk 

assessment is a critical, positive development. Thus, I believe that EPA has made a 

bold and constructive proposal that is scientifically sound and should be strongly 

supported, approved, and implemented. 

6 
15 


33371.008

Senate Committee on Environment and Public Works 

Subcommittee on Superfund, Waste Management, and Regulatory Oversight 

Hearing entitled, "Oversight of the Environmental Protection Agency's Implementation of 

Sound and Transparent Science in Regulation" 

October 3, 2018 

Questions for the Record for Dr. Calabrese 

Senator Markey: 

Senator Markey: General Response Statement: 

None of the questions provided by Senator Markey directly addressed subjects discussed in my 

prepared testimony for the Senate hearing of October 3, 2018. Only question #I was related by 

way of a potential implication but still was beyond the scope of my testimony. Nonetheless, to 

the extent possible, I will attempt to address the questions asked. 

I. Some of the important regulatory actions by EPA in the pesticide field, such as the 

suspension order that took aldrin/dieldrin off the market, were based on animal data, such 

as induction of cancer in mice. At the time there was no proof that aldrin/dieldrin caused 

cancer in humans, and no ethical way of establishing that by experimentations. Would 

that suspension be possible today, if the "sound and transparent science" proposal were 

enacted? 

I don't think that there is a clear answer to this question since the EPA proposal is very 

open ended and non-prescribed for bow cancer risk assessment would be undertaken. It 

appears that EPA is opting for more freedom for their scientists to judge risks and perform 

their assessment on a case-by-case basis. That is, I think that they want their scientists to 

have the flexibility to follow the data rather than be forced to follow a very prescribed 

default model approach, such as the LNT. I have submitted my comments into the record, 

offering a prescribed basis called model uncertainty. This process integrates optimal 

features of LNT, threshold, and hormesis in a straightforward fashion that could be used to 

inform and guide the risk assessment process for non-carcinogens and carcinogens. 

2. You have stressed your past opposition to smoking on airplanes, yet the brochure of your 

2004 Dose-Response conference shows contributions from R.J. Reynolds, Phillip Morris, 

Corillard, and British-American Tobacco. Can you see any possible circumstance under 

which tobacco in any form could be found to have a hormetic effect? If so, please 

describe it. If not, why do you think these companies thought it was in their interest to 

subsidize your conference? 

The area of smoking and the possibility of hormesis could best be studied within an 

epidemiological framework. My area of expertise is as a toxicologist. Thus, whether 

hormetic effects could occur from exposures to tobacco products in humans would be an 

hypothesis that could be studied but it is outside of my area of expertise. 

The question was raised as to why some tobacco companies provided support for a 

conference I directed in the early-mid 1990s. I suspect that they responded to my request 

Page 1 ofS 
16 


33371.009

for financial support and someone in authority must have thought it was in their best 

interests. It should be noted that I requested permission from the University of 

Massachusetts to make such as request to Tobacco companies several years prior to that 

time. However, permission was not granted initially. The request was brought to the UMass 

Board of Trustees and eventually approved. My understanding is that all external sponsors 

must follow a set of prescribed UMass rules and groups such as Tobacco companies are not 

excluded as long as they follow all UMass sponsorship rules. 

3. You have referred to yourself as being the author of "nearly 900 pages in the peerreviewed literature.'' (Testimony I 0/3/18, p I). How many of those pages appeared 

exclusively in Dose-Response, the journal that you founded and are now the editor for? 

The answer is 13. I might add that it is very common for editors to publish in their 

journals. Most editors I know do this modestly as would be the case with my history. 

Please note that I typically publish 20 or more papers per year. Thus, the proportion of my 

papers published in Dose Response is about 5% or possibly less. 

4. In 2015, you published an article in the journal "Environmental Research" with the title, 

"On the origins of the linear no-threshold (LNT) dogma by means of untruths, artful 

dodges and blind faith." Later, solely on the basis of the publication of that article, you 

demanded that the editors of the magazine "Science" retract an article published in 1956. 

Did the editors of Science agree to that demand, and if not, how do you explain their 

refusal? 

The editor did not agree with my request. As to why my request was denied, this would 

have to be addressed by the editor directly. I am attaching my published assessment of this 

situation. 

5. In an article in Dose-Response entitled "Atomic Bomb Health Benefits," Dr. Thomas J. 

Luckey wrote, "One burst of low dose irradiation elicits a lifetime of improved health." 

Dose Response, 2008; 6(1): 97-112. Do you agree with respect to the health benefits of 

atomic bombs? 

a. In the same article, which as editor you presumably approved, Dr. Luckey 

suggested that survivors of a nuclear bomb blast should receive additional 

radiation. Do you agree? 

I am not an expert on the effects of atomic bomb blasts on people. I have not studied this 

issue in a detailed manner. 

The fact that a paper is published in the journal I edit has little to no relationship to my 

thoughts on the matter. I tend to follow the peer-review comments closely and almost never 

over turn a recommendation. 

Page 2 ofS 
17 


33371.010

6. Dose-Response published Dr. Luckey's 2006 article, "Radiation Hormesis: The Good, 

the Bad, and the Ugly." (2006; 4(3): 169-190. In it he wrote: "Premature cancer deaths 

are caused by insufficient radiation ... the United States has about 275,000 preventable 

premature cancer deaths each year. The cause is attributed to insuflicient radiation ... 

[W]e need radiation supplementation for more abundant health. Do you agree? 

b. In the same article, Dr. Luckey wrote that if EPA succeeded in reducing 

household radon exposures, the result would be to cause "many lung cancer 

deaths." Do you agree? 

c. Tn the same article, published by you, Dr. Luckey wrote, "Nuclear waste could 

provide safe radiation spas throughout the world." Do you agree? 

These are research questions that could be tested. There are many studies of human 

populations where the radiation exposure is far higher than average. These might provide 

opportunities to evaluate questions relating to elevated human exposures to various types 

of ionizing radiation under differing environmental conditions and cultural circumstances. 

I would not speculate on the outcome of a study in advance. I am attaching an 

epidemiological study of radon exposure/lung cancer in Worcester County, Massachusetts 

that may provide some relevant insight to your question. 

7. You have repeatedly declared that the Linear No-Dose Threshold Theory (LNT) was the 

product of scientific misconduct, originating with the Nobel Prize acceptance speech of 

Dr. Hermann Muller, who received the Nobel Prize in chemistry in 1946. (see 

hllr:f\' l\\\21 s_t<;eJllt!IY2'£ i,:nccl.£t:l.L£oJnL\ rt i <;).<?.s 2 QJl/Lilll: 

2011 Imcn·icl\ Calal}rcsc~). You seem to theorize that Dr. Muller deliberately lied, 

and that scientists and regulators have suppressed the truth about radiation ever since. Is 

it possible that there is an honest difference of opinion between you and the NAS, EPA, 

NRC, IAEA, TCRP, NCRP, etc.? 

I am not sure to what extent my opinions differ with specific individuals or specific 

organizations. I do not know who represents EPA, NRC and the other groups listed. I do 

not know who in those groups have read any of my papers and what their understandings 

are. 

8. In 2016, Dose-Response published a commentary by Dr. CarolS. Marcus ("Destroying 

the Linear No-Threshold Basis for Radiation Regulation," 2016 Oct-Dec; 14(4)), which 

described the regulation requiring licensees of nuclear facilities and materials to keep 

radiation doses to workers and the public "as low as reasonably achievable" (ALARA), 

as "nonsensical." She wrote: "What if large numbers of licensees went on an ALARA 

strike?" Do you agree that NRC licensees should consider this form of civil 

disobedience, by deliberately refusing to follow the ALARA regulation? 

I do not have knowledge of NRC licenses duties and responsibilities. It not something that I 

have studied or worked on. 

Page 3 ofS 
18 


33371.011

9. The same contributor, Dr. CarolS. Marcus, wrote in a 2015 rulemaking petition to the 

NRC that the thousands of thyroid cancers diagnosed in the former Soviet Union among 

children exposed to radiation from the Chernobyl accident were not in fact caused by 

radiation, as "the radiation doses were too low to have caused this." Do you agree? 

I have not studied this question and do not have an opinion on it. 

Senator Sanders: 

10. As you know, medical studies with human subjects typically provide the basis for 

policies designed to protect public health. However, the individual health data of study 

subjects is required by federal law to remain confidential, which can make study results 

hard, if not impossible, to reproduce. If the EPA's proposed "Strengthening Transparency 

in Regulatory Science" rule (the rule) is implemented, these studies relying on human 

medical records may no longer be used. As you noted in your testimony, studies based on 

human medical records are superior to studies based on animal models, which tend to be, 

according to you "highly susceptible and often poorly predictive". 

During the hearing, you also used the term "secret science" to refer to scientific studies 

that deal with animal models rather than hwnan populations, suggesting again that these 

animal model studies are inferior to those based on human subjects. 

Given that the rule would increase the EPA's reliance on this type of"secret science" you 

disavowed during the hearing, please describe your plan, including a timeline, for 

publicly opposing the rule and revising your testimony. 

Please explain how relying more heavily on these poorly predictive animal models 

advances the EPA's stated mission to "protect human health and the environment". 

I re-read my prepared statement and did not find the term "secret science" mentioned. 

Senator Barrasso stated (page 42): Dr. Calabrese, your testimony also states that hidden 

assumptions in the EPA's secret science are often kind of silent drivers of regulatory 

action. Could you please describe how secret science can bias decisions made from a 

regulatory standpoint? My written testimony was mischaracterized by linking the concept 

of "hidden assumptions" in the risk assessment process to "hidden assumptions in the 

EPA's secret science" .... l never linked hidden assumptions in risk assessment to "secret 

science". 

The question posed does not relate to my comments or misunderstood my comments ... .I 

referred to the use of "multiple assumptions, some of which are frequently hidden, 

obscured and often silent drivers of regulatory action." I then gave the example of the usc 

of highly susceptible animal models that do not predict human responses well. 

I believe that the question posed by Senator Sanders misses the concept I was trying to 

convey. I did not disavow any type of study. I simply requested that EPA needs to fully 

describe/explain the assumptions relied upon when interpreting studies for human 

responses. Failure to describe the assumption relied upon can be problematic since one 

Page 4 of 5 
19 


33371.012

cannot then fully understand the procedures used by the EPA in the risk assessment 

process. 

II. Many epidemiological studies based on human subjects are only possible due to existing 

human exposure to toxic chemicals. These studies are obviously not reproducible because 

knowingly exposing human study subjects to toxic chemicals is unethical. These studies 

are extremely valuable in helping agencies like the EPA formulate effective policies to 

protect public health. If the rule is implemented, it would allow outside interests to 

"disprove" these irreproducible, yet scientifically sound, studies simply because those 

interests do not like the outcomes. 

Please describe the safeguards in the proposed rule to ensure that these types of 

scientifically sound, but ethically irreproducible, studies are not rejected by the EPA. 

This area is outside of my expertise. However, I strongly support the use of all valid studies. 

Please note that it is very unlikely that any study perfectly replicates one another. There 

are always some differences. This is why each study tells something unique and should be 

used in the assessment process. It is also why I believe that a type of carefully described 

weight of evidence procedure should be developed, peer-reviewed, and used. EPA has used 

weight of evidence procedures in the past for cancer risk assessment guidelines. These 

could be updated, peer reviewed and employed to objectively guide Agency procedures. 

Page 5 of 5 
20 

Senator ROUNDS. Thank you, Mr. Calabrese. 

Now we will turn to Mr. Robert Hahn for your opening statement. 

STATEMENT OF ROBERT HAHN, VISITING PROFESSOR, OXFORD UNIVERSITY SMITH SCHOOL OF ENTERPRISE AND 

THE ENVIRONMENT 

Mr. HAHN. Thank you, Chairman Rounds, Ranking Member 

Booker, and distinguished members of the Committee. 

Most of you folks are probably old enough to remember the movie 

The Graduate with Dustin Hoffman. There was a scene early on in 

The Graduate where he is wandering around aimlessly by the 

swimming pool and a gentleman comes up to him and whispers the 

word plastics. 

Well, the word I want to whisper to you today, and Senator 

Booker and Senator Rounds touched on this in their opening remarks, is the importance of evidence. There is a virtual explosion 

going on in the Academy in which I work as an economist in developing evidence based policy. 

Just moving a little bit beyond the pros and cons of this legislation, which I will talk about in a minute and give my perspective 

on, I think there is a real opportunity politically to move forward 

in basing decisions that politicians and civil servants make about 

regulatory decisions and other programs, and basing them on evidence based policy, and that is where I would like to see us going. 

That is sort of my big ax to grind. So, if I run out of my 5 minutes, 

I have at least made my political statement, which is probably a 

good thing to do if I am going to run for President, which I am not. 

I want to make a few points and conclude with a short plea for 

breaking the political logjam. 

The first one is that I believe that the HONEST Act, as it is 

called, addresses a very important public policy issue, and it does 

so in a constructive way. That is not to say that it is perfect or 

can’t be improved, but I am very sympathetic with the direction in 

which it and the EPA proposal is trying to move us. 

The second point is why simply apply this to EPA? There are a 

lot of regulatory agencies and programmatic agencies in Washington, DC. We might want to think about expanding the kinds of 

ideas that Senator Rounds and Senator Booker talked about. 

And the third point I want to make is the point I just made 

about better evidence decisionmaking related to a commission I 

served on that President Obama was instrumental in starting, 

along with Congressman Ryan and Senator Murray. 

So, point No. 1. The HONEST Act addresses an important public 

policy concern. I am just going to give you one example, so it is 

proof by anecdote. I have about 3 minutes. 

So, I ran a center for about 10 years between two think tanks 

in Washington, DC, the AEI Brookings Center on Regulatory Policy, or some such thing. I was doing a study with Ted Gayer, who 

is now at Brookings, trying to figure out what was going on with 

mercury emissions in a proposed regulation that EPA had on mercury emissions, and it took us a really long time to figure out what 

was going on because we didn’t have easy access to the data or the 

models. We found, in our independent analysis, that that particular 

21 

rule, as it was tailored, probably wouldn’t pass a benefit-cost test, 

and we published our findings in science. But that is of secondary 

importance. 

What is of primary importance is the point that the Ranking Minority Member and the Chair pointed out, that we want to have 

these data made available and these models made available in a 

way that academics and other interested parties can check on the 

findings before they go into force. 

Let me move on to a second point under this, and it relates to 

my specific views on the strengthening transparency and regulatory science proposal that EPA had. 

There can be honest differences of opinion, but what would that 

proposal have done? It would have required the EPA to identify 

studies that are used in making regulatory decisions, it would have 

encouraged studies to be made publicly available to the extent 

practicable, and it would direct the EPA to clearly state and document assumptions made in regulatory analyses. 

Now, if I were grading an exam, say, at the Kennedy School, 

where I was on the faculty many years ago, and a student didn’t 

do that, they probably would have gotten a C or less. In other 

words, these are things that make common sense, at least from my 

point of view. 

Here is what, in my view, the EPA rule wouldn’t do: it wouldn’t 

nullify existing environmental regs; it wouldn’t disregard existing 

research, violate confidentiality protections, or jeopardize privacy. 

Let me move on to my conclusion, which is repeating my opening 

introduction. 

I think there is a real opportunity here for the Congress to move 

forward in promoting a new era in terms of getting people to acquire and use data more intelligently to improve decisions in government and in the private sector. 

For the government, I believe there is an opportunity to move 

things forward by promoting, as I said before, evidence based policy. It is pretty hard for a politician or an individual of any political 

persuasion to object to the idea of evidence and using better evidence in decisionmaking. I think that is really important. 

I think the HONEST Act represents a modest, albeit important, 

step in the direction of trying to move such policy, and I would 

urge legislators to move swiftly to consider this effort and other efforts that could vastly improve the quality of decisionmaking in 

government and thus improve the welfare of American citizens. 

Thank you. 

[The prepared statement of Mr. Hahn follows:] 

22 


33371.013

Robert Hahn 

Visiting Professor 

Oxford University Smith School of Enterprise and the 

Environment 

Bob Hahn is a visiting professor and former director of economics 

at the Smith School of Enterprise and the Environment, Oxford 

University, and a senior fellow at the Georgetown University Center for Business and 

Public Policy. He has served on the faculties of Harvard and Carnegie Mellon, and has 

also had senior appointments at the American Enterprise Institute (AEI) and Brookings. 

Mr. Hahn co-founded and directed the AEI-Brookings Joint Center for Regulatory 

Studies, a leader in policy research in law and economics, regulation, and antitrust. 

Previously, he worked for the U.S. President's Council of Economic Advisers and was 

the chief economist on the White House drafting team for the 1990 Clean Air Act 

Amendments. His responsibilities included helping to design the innovative cap-andtrade system for limiting smokestack sulfur emissions. 

Mr. Hahn is currently conducting several economics experiments aimed at improving 

productivity, and promoting growth and sustainability. He also continues to do research 

on government regulation, competition policy, energy policy, Internet policy, 

environmental policy, and understanding the benefits of breakthrough innovations. He 

served as a commissioner on the U.S. Commission on Evidence-Based Policymaking 

and is currently working with key decision makers on ways to promote evidence-based 

policy. 
23 


33371.014

Assessment of the Honest and Open New EPA Science Treatment Act of 2017 

or the HONEST Act 

Testimony before the Senate Committee on Environment and Public Works 

Professor Robert Hahn* 

October 3, 2018 

Embargoed until the time of the hearing 

*Visiting Professor, Smith School, Oxford University and Senior Policy Scholar, 

Georgetown Center for Business and Public Policy. The author would like to thank 

Nick Hart and Robert Shea for helpful conversations on this general topic and Jayani 

Chakravarti for excellent research assistance. The views in this testimony are those 

of the author, and do not necessarily reflect the views of the institutions with which 

he is affiliated. 
24 


33371.015

Assessment of the Honest and Open New EPA Science Treatment Act of 2017 

or the HONEST Act 

Professor Robert Hahn 

October 3, 2018 

Good afternoon. My name is Robert Hahn. It is my pleasure to testify before the 

Senate Committee on Environment and Public Works on the HONEST Act. 

I am a visiting professor at the Oxford University's Smith School and a senior policy 

scholar at the Georgetown University Center for Business and Public Policy. I have 

served on the faculties of Harvard University and Carnegie Mellon University and 

also held senior positions at AEI and Brookings. My bio is attached along with 

selected references that may be of interest to the Committee. 

I wish to make three points and conclude with a plea for breaking the political logjam 

in this important area of policy. Here are the three points in a nutshell. 

First, the HONEST Act addresses an important public policy issue in a constructive 

way. The use of sound science in a transparent manner in regulatory decisionmaking is critical for improving the welfare of Americans and consumers more 

generally. 

Second, the issue of using sound and transparent science is one that is germane to 

many government agencies, and some of the ideas in this act could be usefully 

extended to other government agencies. 

Third, there is a more fundamental issue of how to promote better evidence-based 

decision making in government. I will offer some ideas on that as well. 

1. The HONEST Act addresses an impot1ant public policy concern 

Having access to models and data are keys to being able to reproduce and extend 

results, which is important. I recall a research project I did with Ted Gayer on the 

regulation of mercury emissions from power plants. In that research, we reviewed 

EPA documents. It was challenging to replicate the findings of that analysis; and 

even though there was supposed to be a clear benefit-cost analysis, it was difficult to 

connect the dots. Once we connected the dots, we found that the regulation would 

not likely pass a benefit-cost test based on the government's data. It would have 

been very helpful in undertaking this research if we had easier access to the 

scientific models and data underlying that analysis. 

A second strand of my research reinforced this finding. In work with Patrick Dudley, I 

found that environmental regulatory assessments for major regulations done by the 

U.S. Environmental Protection Agency were not always of high quality. For example, 

the agency often did not consider alternatives adequately, or consider a range of 

benefits and costs. In fairness, my understanding is that EPA has done much to 

improve the quality of their analysis since that study, but my understanding is that 

there are still significant issues with modelling and transparency. 
25 


33371.016

Recently, I reviewed an EPA proposed rule on "Strengthening Transparency in 

Regulatory Science" (RIN 2080-AA14), which appears to have a similar goal to the 

HONEST Act. I published an editorial reflecting my views in the Washington Post. 

While many scientists argued that this proposal would likely stifle science in 

administrative rulemaking, I came to the opposite view. 

Critics typically argued that the proposed regulation would suppress research that 

contains confidential records. A careful reading of the rule suggests that it would: 

require the EPA to identify studies that are used in making regulatory 

decisions; ... encourage studies to be made publicly available "to the extent 

practicable" ... and it would direct the EPA to clearly state and document 

assumptions made in regulatory analyses. 

Here's what the EPA's rule wouldn't do: nullify existing environmental 

regulations, disregard existing research, violate confidentiality protections, 

jeopardize privacy or undermine the peer-review process." 1 

The EPA regulations likely have costs and benefits in the billions in the aggregate 

(using OMS's estimates). It is for that reason that I argued that its proposed rule was 

worth considering, and that it should be evaluated on an ongoing basis. 

2. Congress should consider something like the Honest Act for other 

government agencies. 

Greater transparency and accountability for decision making are critical not just for 

the EPA, but for virtually all government agencies that use models and data to 

design programs and regulations. Thus, I believe something like the HONEST Act 

should be considered for most other government agencies -- especially those 

involved with designing and evaluating programs, policies and regulations. 

3. Congress should promote better evidence-based decision making in 

government. 

"Taking steps to increase access to data, with strong privacy protections, is how 

society will continue to make scientific and economic progress and ensure that 

evidence in rule-making is sound." The EPA's proposed rule and the HONEST Act 

follow principles laid out in 2017 by the bipartisan Commission on Evidence-Based 

Policymaking -humility, transparency, privacy, capacity and rigor- and moves us 

toward providing greater access to scientific data while protecting individual privacy. 

Congress should consider adopting the recommendations in this report that would 

improve the basis for making informed government decisions. 

1 Quotations are taken from my Washington Post oped referenced at the end of the testimony. 

2 
26 


33371.017

In addition, Congress should consider legislation that requires all agencies to 

develop programs and regulations that are likely to pass a broadly defined benefitcost test. This legislation could be patterned after executive orders that all presidents 

have used since President Ronald Reagan (e.g., Executive Order 12291 ). In 

addition, Congress should provide funding to evaluate and improve programs and 

regulations on an ongoing basis. 

4. The Political Opportunity 

We may be at the dawn of a new era in terms of acquiring and using data more 

intelligently to improve decisions in government and in the private sector. For 

government decision making, I believe there is an opportunity to move things forward 

by promoting "evidence-based policy". This is something that I believe all elected 

representatives should support, regardless of their ideological preferences or party 

affiliation. 

The HONEST Act represents a modest, albeit important, step in the direction of 

trying to improve evidence-based policy. I would urge legislators to move swiftly to 

consider this effort and other efforts that could vastly improve the quality of decision 

making in government, and thus improve the welfare of American citizens. 

Appendix: Selected References and Bio for Robert Hahn 

Selected References 

Abowd, John M. and Shmutte, ian M., An Economic Analysis of Privacy Protection 

and Statistical Accuracy as Social Choices, forthcoming in the American 

Economic Review. 

Arrow, Kenneth J., et a/. (1996), "Is There a Role for Benefit-Cost Analysis in 

Environmental, Health, and Safety Regulation?," Science 272, no. 5259 (April 

12, 1996): 221-222. 

Gayer, Ted and Hahn, Robert (2005) "Costs and Benefits of Regulating Mercury," 

Science 310, (November 4, 2005): 777-778. 

Cohen, Linda R. and Hahn, Robert (1999). "A Solution to the Controversy Over 

Public Access to Scientific Data," Science 285 (July 23): 535-36. 

"Commission on Evidence-Based Policymaking Report," issued by CEP in 

September 2017. https://www.cep.gov/content/dam/cep/reportlcep-finalreport.pdf 

3 
27 


33371.018

Dudley, Patrick, and Hahn, Robert (2007), "How Well Does the U.S. Government Do 

Cost-Benefit Analysis?" Review of Environmental Economics and Policy 1, 2 

(Summer): 192-211. 

Economist magazine (2018), "Swamp science: Scott Pruitt embarks on a campaign 

to stifle science at the EPA," April 30. 

Greenstone, Michael. 2009. 'Toward a Culture of Persistent Regulatory 

Experimentation and Evaluation." in D. Moss and J. Cisternino (eds.), New 

Perspectives on Regulation, Cambridge, MA: The Tobin Project. 

Hahn, Robert (2018) "Many mocked this Scott Pruitt proposal: They should have 

read it first," Brookings/Washington Post, May. 

Mayo, John (2015) Results Based Regulation: 20th Century Lessons and 21st 

Century Opportunities, September. 

https:!/cbpp.georgetown.edu/publications/results-based-regulation-20thcentu ry-lesson s-and-21 st-century-oppo rtun ities 

4 
28 


33371.019

Bio for Professor Robert Hahn 

Robert Hahn is a visiting professor and former director of economics at the Smith 

School of Enterprise and the Environment, Oxford University, and a senior policy 

scholar at the Georgetown University Center for Business and Public Policy. He is 

also co-founder of The Behavioralist and Signal, two companies that use behavioral 

economics and evidence-based policy making to promote the social good. Bob has 

served on the faculties of Harvard and Carnegie Mellon, and has also had senior 

appointments at AEI and Brookings. Bob co-founded and directed the AEI-Brookings 

Joint Center for Regulatory Studies, a leader in policy research in law and 

economics, regulation, and antitrust. Previously, he worked for the U.S. President's 

Council of Economic Advisers and was the chief economist on the White House 

drafting team for the 1990 Clean Air Act Amendments. His responsibilities included 

helping to design the innovative cap-and-trade system for limiting smokestack sulfur 

emissions. 

Bob is currently conducting several economics experiments aimed at improving 

productivity, and promoting growth and sustainability. He also continues to do 

research on government regulation, competition policy, energy policy, Internet policy, 

environmental policy, and understanding the benefits of breakthrough innovations. 

He served as a commissioner on the U.S. Commission on Evidence-Based 

Policymaking and is currently working with key decision makers on ways to promote 

evidence-based policy. 

5 
29 


33371.020

Senate Committee on Environment and Public Works 

Subcommittee on Superfund, Waste Management, and Regulatory Oversight 

Hearing entitled, "Oversight of the Environmental Protection Agency's Implementation of 

Sound and Transparent Science in Regulation" 

October 3, 2018 

Questions for the Record for Mr. Hahn 

Senator Sanders: 

I. You testified in the hearing that the EPA's proposed "Strengthening Transparency in 

Regulatory Science" rule (the rule) would not ''disregard existing research" nor 

"jeopardize privacy". However, medical studies with human subjects typically provide 

the basis for policies designed to protect public health. Additionally, the individual health 

data of study subjects is required by federal law to remain confidential, which can make 

study results hard, if not impossible, to reproduce. If the rule is implemented, these 

studies relying on human medical records may no longer be used, which will lead to 

some existing research to be disregarded. Using individual health data of study subjects 

will jeopardize their privacy. Please explain how the EPA will be able to implement the 

rule without disregarding existing research or jeopardizing patients' privacy. 

Answer: Theproposed rule says: "Nothing in the proposed rule compels the 

disclosure of any confidential or private information in a manner tliat violates 

applicable legal and ethical protections." 

2. Many epidemiological studies based on human subjects are only possible due to existing 

human exposure to toxic chemicals. These studies are obviously not reproducible because 

knowingly exposing human study subjects to toxic chemicals is unethical. These studies 

are extremely valuable in helping agencies like the EPA formulate effective policies to 

protect public health. If the rule is implemented, it would allow outside interests to 

''disprove" these irreproducible, yet scientifically sound. studies simply because those 

interests do not like the outcomes. 

Please describe the provisions in the proposed rule that would ensure these types of 

scientifically sound, but ethically irreproducible, studies are not rejected by the EPA. 

Answer: See answer to 1. I also quote the proposed rule: "The best available science 

must serve as the foundation of EPA's regulatory actions." Taken together, l believe 

a reasonable interpretation of the rule is that EPA should consider such studies. 

3. The EPA estimates that the HONEST Act would cost $250 million a year to enforce, 

with one of the major costs being the process of redacting private information from 

studies. Yet, the HONEST Act would only authorize a total of$1 million each year for 

enforcement. Do you believe this insufficient funding would impede the EPA's ability to 

enforce the rule and protect confidential health data? If not, please describe how the 

EPA can effectively protect patients' privacy with 0.4 percent of the necessary budget to 

do so? 
30 


33371.021

Answer: EPA cost estimates are often highly uncertain. I cannot comment on the 

validity of this particular cost estimate. I believe the benefits of this proposed rule 

should be weighed against the costs. Based on my experience I believe there are 

substantial advantages to sharing data and models on which important policy 

decisions are based with appropriate researchers. My testimony before the 

committee makes this clear. Thus, I would urge the Congress to encourage EPA 

and other agencies to move in this direction. This argument is consistent with 

many of the recommendations adopted by the U.S. Commission on EvidenceBased Policymaking, on which I served. 

Page 1 ofl 
31 

Senator ROUNDS. Thank you for your testimony, Mr. Hahn. 

We will now turn to our third witness, Dr. Holt. 

Dr. Holt, you may begin. 

STATEMENT OF RUSH D. HOLT, CHIEF EXECUTIVE OFFICER, 

AMERICAN ASSOCIATION FOR THE ADVANCEMENT OF 

SCIENCE 

Mr. HOLT. Thank you. And I do hope to stick to the evidence and 

to the topic at hand. Thank you. 

Chairman Rounds, Senator Booker, I appreciate the opportunity 

to testify before you today on behalf of the American Association 

for the Advancement of Science. 

The AAAS is the world’s largest general scientific membership 

organization publisher of Science magazine, among other things, 

and our mission is to advance science, engineering, and innovation 

throughout the world for the benefit of all people. We also represent 250 affiliated societies. 

The transparency rule that you are considering is opposed by 

many, I think most, scientists and scientific organizations because, 

contrary to the stated purpose of the rule, the rule would result in 

the exclusion of valid and important scientific findings from the 

regulatory process, as Senator Booker has said. 

Transparency, openness, and peer review and regulatory science 

are essential ingredients of science, as espoused by AAAS since the 

founding in 1948. However, the so called transparency rule is an 

insidious dodge. 

Those who want to overturn the EPA procedures with this rule 

provide no good evidence that there is any deficiency in the scientific research that has been used up until now. Excluding the 

kinds of peer reviewed research that has been used is not justified. 

To put it bluntly, the initiative you consider today is not about 

transparency or sound science; it apparently is about reducing regulations. We know this because the architects and proponents 

present their proposals as part of a deregulatory agenda. 

But most important, whatever the ulterior purpose may or may 

not be, the effect of the rule would be a significant reduction in 

good, relevant science that could be used by EPA, and the change 

would likely result in harm to people and the environment. 

The proposed rule and its strict application would allow only research that is made completely public, and this demonstrates either a deep misunderstanding of how science works, and should 

work, or an intention to cherry pick evidence in the name of transparency. 

There are numerous examples of excellent peer reviewed research where some data cannot be published openly or where the 

experiment cannot be precisely repeated, and where redaction and 

anonymizing won’t work. The most obvious examples are research 

projects that study human illness resulting from pollutants, for example. 

There are accepted procedures for testing results and verifying 

outcomes with methodologies that do not require access to all the 

raw data, so it doesn’t need to be fixed. That is my point there. 

The U.S. Department of Defense has said the EPA transparency 

rule would be problematic. EPA’s own Science Advisory Board 

32 

questioned whether it would be possible to implement the rule as 

proposed. The current Deputy Assistant Administrator of EPA’s 

Chemicals Office stated that ‘‘such a requirement would be incredibly burdensome, not practical,’’ and could justify all TSCA risk 

evaluations; not to mention the many, many scientists and scientific societies who see this rule as damaging. 

The proponents of the rule want to eliminate secret science. 

There is no secret science here. The only secret that I see is the 

deficiency that the authors of the transparency rule see in the existing research used by EPA. The open secret is that the proponents of the rule are not seeking a better scientific process; they 

appear to be seeking a way to cherry pick research in order to loosen regulations. 

So, I recommend that you scrap these initiatives and work with 

the science community and other stakeholders to increase the use 

of science in the regulatory process, not to find ways to decrease 

the science that can be used. 

I thank you for your time, and I will be happy to take any questions. 

[The prepared statement of Mr. Holt follows:] 

33 


33371.022

Rush D. Holt 

Chief Executive Officer 

American Association for the Advancement of Science 

Rush D. Holt, Ph.D., became the chief executive officer of the 

American Association for the Advancement of Science (AAAS) 

and executive publisher of the Science family of journals in 

February 2015. In this role, Holt leads the world's largest multidisciplinary scientific and engineering membership organization. 

Over his career, Dr. Holt has held positions as a teacher, scientist, administrator, and 

policymaker. From 1989 to 1998, Holt was assistant director of the Princeton Plasma 

Physics Laboratory (PPPL), a Department of Energy national lab, which is the largest 

research facility of Princeton University and one of the largest alternative energy 

research facilities in the country. At PPPL, Holt helped establish the lab's nationally 

renowned science education program. From 1980 to 1988, Holt was on the faculty of 

Swarthmore College, where he taught courses in physics and public policy. In 1982, he 

took leave from Swarthmore to serve as an AAAS/Arnerican Physical Society Science 

and Technology Policy Fellow on Capitol Hill. From 1987 to 1989, Holt served as an 

arms control expert at the U.S. State Department, where he monitored the nuclear 

programs of countries such as Iraq, Iran, North Korea, and the former Soviet Union. 

Before coming to AAAS, Holt served for 16 years as a member of the U.S. House of 

Representatives, representing New Jersey's 12th Congressional District In Congress, 

Holt served as a member of the Committee on Natural Resources and the Committee 

on Education and the Workforce. He served on the National Commission on the 

Teaching of Mathematics and Science (known as the Glenn Commission), founded the 

Congressional Research and Development Caucus, and served as a co-chair of the 

Biomedical Research Caucus. Holt served eight years on the Permanent Select 

Committee on Intelligence and, from 2007 to 2010, chaired the Select Intelligence 

Oversight Panel, which worked to strengthen legislative oversight of the intelligence 

community. His legislative work earned him numerous accolades, including being 

named one of Scientific American magazine's "50 National Visionaries Contributing to a 

Brighter Technological Future" and a "Champion of Science" by the Science Coalition. 

He has also received awards from the American Chemical Society, the American 

Association of University Professors, the National Association of Graduate-Professional 

Students, the American Institute for Medical and Biological Engineering, the Council of 

Scientific Society Presidents, the American Geophysical Union, and the Biotechnology 

Industry Organization. Holt is a past recipient of two of AAAS' highest honors: the 

William D. Carey Lectureship Award (2005) and the Philip Hauge Abelson Award 

(2010). 

Holt is a Phi Beta Kappa graduate of Carleton College in Northfield, Minnesota, and he 

holds MA and Ph.D. degrees in physics from New York University. He is married to 

Margaret Lancefield, a physician, and they have three children and seven 

grandchildren. 
34 


33371.023

Testimony before the 

Senate Energy and Public Works Committee 

Subcommittee on Superfund, Waste Management, and Regulatory Oversight 

by 

Dr. Rush D. Holt 

American Association for the Advancement of Science 

October 3, 2018 

Chairman Rounds, Ranking Member Booker, and esteemed committee members, 

thank you for the opportunity to testify before you today on behalf of the American 

Association for the Advancement of Science, or AAAS. AAAS is the largest general 

scientific membership society in the world, and publisher of the journal Science. Our 

mission is to advance science, engineering, and innovation throughout the world for 

the benefit of all people. 

You are considering the science that goes into EPA regulations. EPA is legally 

required to base its work on current scientific research. For almost a half century 

the Environmental Protection Agency has implemented legislation written to protect 

the health of people and their environment, saving countless lives. The Transparency 

Rule that you are considering is opposed by many - I think, most - scientists and 

scientific organizations because, contrary to the stated purpose of the rule, the rule 

would result in the exclusion of valid and important scientific findings from the 

regulatory process. 

Of course, everyone wants transparency, openness, and peer review in regulatory 

science. These are essential ingredients of science espoused by AAAS since its 
35 


33371.024

founding in 1848. However, this so-called Transparency Rule is an insidious dodge. 

There is no good evidence provided by those who want to overturn the successful 

procedures of EPA that there is any deficiency in the scienti fie research that has been 

used until now. Excluding the kinds of peer reviewed research that has been used is 

not justified. 

To put it bluntly, the initiative you consider today- the Secret Science Act of some 

years ago, which became the HONEST Act, and then turned into the Transparency 

Rule- is not about transparency or sound science. Jt is about reducing regulations. 

We know this because the architects and proponents present these proposals as part 

of a deregulatory agenda. Most important, whatever the ulterior purpose may or 

may not be, the effect of the rule would be a significant reduction in good, relevant 

science that could be used by EPA. This change would likely result in harm to 

people and their environment. 

The proposed rule says that only research about which every detail is made 

completely public could be used in regulatory decision making because the research 

must be subject to exact replication. That demonstrates either a deep 

misunderstanding of how science works (and should work) or an intention to cherrypick the evidence in the name of transparency. 
36 


33371.025

There are numerous examples of excellent, peer-reviewed research where some data 

cannot be published openly or where the experiment cannot be precisely repeated. 

The most obvious such examples are research projects that study human illness 

resulting from pollutants. You do not need to know the names of the victims who 

breathe dirty air or drink tainted water to know the science is done right. There are 

accepted procedures for testing results and verifying outcomes with methodologies 

that do not require access to raw data. Furthermore, using only studies that can be 

repeated precisely would eliminate, for example, studies of emissions of smelting 

plants that no longer exist or studies of a natural disaster that can shed light on 

continuing environmental insults. 

The U.S. Department of Defense said the EPA transparency rule was problematic. 

The EPA's own Science Advisory Board questioned whether it would be possible to 

implement the rule as proposed. The current deputy assistant administrator of EPA's 

chemicals office stated when first reviewing the proposed rule internally, "such a 

requirement would be incredibly burdensome, not practical" and could jeopardize 

all TSCA risk evaluations because proprietary chemical process information would 

not be made public. 

The proponents of the rule say they want to eliminate "secret science." There is no 

secret science. The only secret is the deficiency that the authors of this Transparency 

Rule see in existing research used by EPA. The open secret is that the proponents 
37 


33371.026

of the rule are not seeking a better scientific process. They appear to be seeking a 

way to cherry pick research in order to loosen regulations. 

I urge you to scrap these initiatives and work with the scientific community and other 

stakeholders to increase- not decrease- the use of science in the regulatory process. 

Thank you for your time and for allowing me to testify, and I would be happy to 

answer any of your questions. 
38 


33371.027

Senate Committee on Environment and Public Works 

Subcommittee on Superfund, Waste Management, and Regulatory Oversight 

Hearing entitled, "Oversight of the Environmental Protection Agency's Implementation of 

Sound and Transparent Science in Regulation" 

October 3, 2018 

Questions for the Record for Dr. Holt 

Senator Markey: 

I. How important do you think considering the science and evidence is for meeting the 

obligation of supporting "best available science" required by the Clean Air Act and many 

other EPA regulations? 

Regulations and agency actions do indeed need to be informed by the best available 

science and a rigorous scientific process free from political interference. It is for this 

reason that AAAS opposes issuing a rule that would restrict the ability of a federal 

agency to utilize rigorous science as it establishes policies and that could have long-term, 

negative consequences to public health and the environment for all Americans. 

Science, and the evidence that supports that science, are key to any interpretation of the 

notion of"best available science." The best available science should be science that 

continually reexamines previous findings and further advances the field of knowledge so 

regulations are updated with the latest information that science produces- not the kind 

that politicians would select to achieve a specific end. 

2. In general, do you think the proposed secret science rule is more likely to increase or 

decrease the amount of peer-reviewed science being considered in regulations? 

As we stated in our comments to the Federal Register, AAAS is very concerned that 

EPA's proposed rule will prevent the use of the best available scientific studies in setting 

critical public health and environmental policies in cases where the underlying data 

cannot or should not be made publicly available. If put into practice, the proposed rule 

will prohibit the agency from using a wide swath of high-quality, past and present 

scientific research. Requiring all raw data to be made publicly available before a study 

can be utilized in EPA decision-making will cut off EPA from foundational research that 

has informed EPA's work since the inception of the agency and may violate Federal laws 

and directives already in place. 

a. Some of the important regulatory actions by EPA in the pesticide field, such as 

the suspension order that took aldrin/dieldrin off the market, were based on 

animal data, such as induction of cancer in mice. At the time there was no proof 

that aldrin/dieldrin caused cancer in humans, and no ethical way of establishing 

that by experimentations. How confident are you that this suspension would be 

possible today, if the "sound and transparent science" proposal were enacted? 

While animal studies do not contain protected health data of human research 

subject, they do often contain propriety or confidential business information. 

Page 1 of3 
39 


33371.028

Companies who produce substances like aldrin/dieldrin often submit their 

proprietary data to EPA with the explicit understanding it will not be publicly 

released. Industry, alongside the scientific community, has expressed concern that 

that the proposed transparency mle would negatively impact their ability to work 

with the EPA if all data were to be made public. 

b. Safe Drinking Water Act Regulation for radionuclides relied on epidemiological 

studies of survivors from the Hiroshima and Nagasaki atomic bomb attacks. 

Would studies like these be considered by the EPA under this new science rule? 

AAAS believes that many epidemiological studies will be prohibited from use by 

the EPA in setting regulatory decisions under the new transparency rule as they 

contain private health information of research participants that cannot be made 

publicly available. ln addition, AAAS is concerned that for studies like the one 

mentioned above, which only happen once and cannot nor should not be repeated, 

that overly narrow prescriptions of how studies should be verified could prohibit 

research or data on singular events from being used. lt is vital, as AAAS has 

repeatedly stated in comments to both the legislation and proposed rule, that the 

scientific process be freed from political influence or exacting guidelines that 

would hinder the advancement of new science. 

c. Are there any other existing regulations you would like to note as being 

particularly at risk if the "secret science" proposal is enacted? 

Regulations that use science as the foundation for their actions, like the Clean Air 

Act and Clean Water Act, would be at risk if the transparency rule is enacted. 

While the rule, and legislation like the Secret Science Act, are specific to EPA we 

have expressed concern that if enacted it could be used as a justification to 

implement similar policies at other agencies. This would in turn place any 

regulation at risk that uses science as major contributor to the justification for new 

regulations. 

3. A brochure for the 2004 International Dose-Response Society conference shows 

contributions from R.J. Reynolds, Phillip Morris, Corillard, and British-American 

Tobacco. Why do you think these companies would subsidize this kind of scientific 

conference? 

AAAS believes in the practice, use and promotion of sound science, regardless of 

funding sources. While many have cast science funded or conducted by corporate entities 

as tainted, we believe good science is science that is performed with integrity, adheres to 

the scientific method, and holds up to scrutiny. If research is funded by a corporation and 

still meets the high standards of good science, then it is still good science. However, if 

concerns exist that a funding source places a bias in the research or researchers, federal 

agencies should utilize their scientific integrity policies to protect against such biases. 

Page 2 of 3 
40 


33371.029

4. In 2015, Dr. Edward Calabrese published an article in the journal "Environmental 

Research" with the title, "On the origins of the linear no-threshold (LNT) dogma by 

means of untruths, artful dodges and blind faith." Later, solely on the basis of the 

publication of that article, he demanded that the editors of your journal, "Science," retract 

an article published in 1956. How did you and your editors respond to that demand and 

why? 

The editors of Science did respond to Dr. Calabrese and his colleagues on their 2015 

request to retract a 1956 article based on alleged scientific misconduct. The response was 

that in cases of scientific misconduct, which involves either plagiarism or the falsification 

or fabrication of data, it is the responsibility of the institution where the research was 

conducted to investigate such misconduct and to decipher whether the accusation has 

merit. Journals do not have the resources to conduct such an investigation. It was also 

noted that in this case it would be difficult to fully investigate misconduct as the original 

researchers arc deceased. Lastly, the response also referenced that the 1956 paper in 

question was one of hundreds over the past half century on this broad topic, and the use 

of the LNT model is now based on more than the National Research Council's report in 

question and Dr. Mueller's work. Based on these factors Science did not consider 

retracting the paper. 

Page 3of3 
41 

Senator ROUNDS. Dr. Holt, thank you for coming and testifying 

today. 

Each of the Senators now has the opportunity for a 5-minute 

Q&A with you, and I will begin at this time. 

I would like to start with Mr. Hahn. I would just like to ask over 

a multi-period of time you have written extensively on the need for 

greater scientific transparency with regard to regulations that have 

an enormous impact on the economy and the quality of life for the 

American people. What do you believe has been the primary motivating factor behind not pursuing greater transparency prior to the 

current Administration? 

Mr. HAHN. I am not sure I have a 1-minute answer to that question, but I guess I think about it on a couple levels. Sometimes 

there is raw politics involved in particular issues where Congress 

may feel strongly about doing something, and it may not be in its 

own interest to necessarily get to the heart of the scientific matter. 

I think partly it is a matter that agencies don’t always adapt to 

the latest technology, so we have the Internet now, we have easy 

ways of sharing things. It is worth, in my view, putting some resources into some of the issues that Dr. Calabrese mentioned earlier so that people can have access to the kinds of data bases that 

he developed, but I am thinking of the government, the models on 

which they are building things. 

So, for example, when we were writing the Administration’s 

version of the Clean Air Act, EPA used a consultant that didn’t 

share its model, and a lot of the Clean Air Act was being driven 

by the results of this model, in my opinion, and I don’t think that 

was an appropriate way to conduct the development of that very 

important piece of legislation. 

Senator ROUNDS. Thank you. 

Dr. Calabrese, as a scientist, can you speak to the value of studies that can be replicated? 

Mr. CALABRESE. Replication is a pretty complicated question because it is really—in many ways, replication is the gold standard, 

especially when you are dealing with low dose exposures. High dose 

exposures is one thing, where you kind of overwhelm systems with 

massive exposures, and you can see effects, but human exposures 

are going to be at much lower levels, and you really want to see 

if there are adverse effects that you are trying to prevent and you 

think might be occurring, then you want to be able—in your experimental systems, you want to be able to see if these findings are 

reproduceable or not. 

The problem with these types of things is that, especially with 

regards to epidemiologic data and to somewhat minor effects, a lot 

of times a study comes out positive in one and then can’t be replicated in many other studies. So the gold standard is that we really have to hold the scientific researchers accountable for essentially 

providing reliable information to regulatory agencies and to society 

to give us confidence that the findings are sustainable and are believable, and this doesn’t have to necessarily involve an exact replication, but would have to involve some type of confirmatory reliability that is substantial, that adds strong weight of evidence to 

any conclusion. 

Senator ROUNDS. Thank you. 

42 

Dr. Holt, I am just curious. It would seem to me that for those 

of us that have to make decisions based upon recommendations 

from any type of an agency, in this case either Republican or Democrat, it seems to me the most data that we can get, and that 

which can be identified as being scientifically and peer reviewed, 

would be welcome by the scientific community, but you have expressed a real doubt about the intent of moving forward with that, 

and I am just curious. It seems as though the movement toward 

using sound science and one with as much transparency as possible 

would be a positive thing, and I am just curious. 

I have heard your opening statement, but I am kind of surprised 

that there wouldn’t be more of a welcoming to a peer reviewed discussion with a number of different points of view that would be 

brought in, and I am missing something, I think, on it. Could you 

maybe elaborate a little bit, please? 

Mr. HOLT. Yes, thank you. Surely, you do want verification. EPA 

is required to base their work on science, actually different from 

most regulatory agencies. It is written into the laws. In other 

words, you should be using current science. And the science is not 

just the collection of data; it is collection of data in a way that removes bias; it is assembly of the data that—I mean, it has to be 

empirical, based on experiment, observation, and then it has to be 

verified, and that is the key word. 

It is really a red herring to say replication is what is necessary. 

The verification can come in various ways: through repeating the 

experiment, if it is an experiment. But even most experiments are 

hard to repeat exactly, and certainly natural disasters. Senator 

Booker referred to the Gulf oil discharge. Let’s hope that isn’t repeatable. There are many circumstances where it can’t be repeated 

in exactly the same way. 

But it can be verified through peer review, through independent 

verification, through confirmation of the studies by putting them in 

the context of other studies. That is the way science works. And it 

is science, this whole process that you want to be maximized in the 

regulatory process. 

Senator ROUNDS. Thank you. 

Senator Booker. 

Senator BOOKER. I am going to defer to my colleague and friend, 

Senator Carper. 

Senator ROUNDS. Senator Carper. 

Senator CARPER. Thank you so much for deferring. 

A quick question of you, Dr. Holt. I am not going to ask a yes 

or no question of you, but anything that the other two witnesses 

said that you would say, yes, that is right, I agree with that? Have 

they said anything that you agree with? 

Mr. HOLT. Well, yes. I mean, certainly that we need—— 

Senator CARPER. Briefly mention one of the things that you may 

heard. 

Mr. HOLT. Yes. More evidence. Clearly, we always want more 

evidence in this day and age, when evidence, opinion, and ideology 

are considered interchangeable. 

Senator CARPER. Good. 

Same question, Dr. Calabrese, of you and Mr. Hahn. Anything 

that Rush said that you agree with even a little bit? 

43 

Mr. CALABRESE. I would have to say I agree only a little bit with 

a couple of points that he made, and that is in many ways, I agree, 

the Agency is directed toward science based regulation. But the 

problems with science based regulation are the assumptions upon 

which the science essentially feeds into, and that is that we have 

national toxicology program studies that use very high doses, three 

doses at extremely high doses that may be 100,000-fold more than 

what people may be exposed to, and we have unverified—— 

Senator CARPER. I am going to stop right there. Thank you. We 

will ask you to continue to respond for the record, if you will. I 

have little time. 

Mr. Hahn, anything that he said that you actually agree with? 

If you could be very brief in stating. 

Mr. HAHN. The answer is yes, and I think we all agree that agencies should use the best science, and they should have a transparent process so people and experts can understand what we are 

getting. I think the point of disagreement is about whether the proposals before us, the proposed rule and the HONEST Act, whether 

they move the ball forward or whether they don’t, and my reading 

is that they do move the ball forward. 

Senator CARPER. OK. Thank you. 

A question, if I could, of Dr. Holt. I think it was in May of this 

year we learned that political appointees within EPA have stalled 

the release of EPA’s formaldehyde risk assessment. The risk assessment reportedly concludes that formaldehyde causes cancer 

and leukemia. This health assessment has been years in the making and is ready to be peer reviewed, but EPA’s political folks are 

insisting on keeping it under lock and key in response to industry 

pressure. 

My question of you, Dr. Holt, is how would you respond to the 

concern that EPA is keeping its own formaldehyde science secret, 

while simultaneously claiming that it needs a new rule to 

‘‘strengthen the transparency of EPA’s regulatory science’’? 

Mr. HOLT. Senator Booker pointed out the irony in this. There 

does seem to a double standard there. I am not expert on the formaldehyde study per se, and in fact, much of it is not available for 

examination. 

Senator CARPER. All right. 

Let me try another question, if I could, Dr. Holt. EPA’s 23 Federal advisory committees were established, I believe, to advise the 

Agency on environmental science, on public health safety, and 

other subjects that are central and critical to EPA’s work. 

Last year EPA announced that it would prohibit scientists who 

receive EPA grants from serving on its Federal advisory committees. In 1999 a Federal appellate court rejected a nearly identical 

approach at HHS, reasoning that members of these committees are 

‘‘selected because they are experts in that field’’ and therefore, it 

is not surprising that HHS would also fund their research. 

My question: Given that EPA’s advisory committees should include the best scientists, shouldn’t EPA eliminate its seemingly unlawful effort to exclude anyone with an EPA grant from serving on 

them? 

Mr. HOLT. Senator, I would refer you to a statement that we 

made, our organization made some months ago. I won’t take much 

44 

time from this hearing because that is somewhat apart from the 

subject of this hearing, but in EPA in particular, the science advisory process is essential. And I don’t want to get into how much 

or if it is being degraded, but it is important to defend that scientific advisory process in the EPA. 

Senator CARPER. All right. 

One last question, Dr. Holt. Given that the rulemaking process, 

rewriting a rule or litigating a rule, are costly endeavors, shouldn’t 

EPA either withdraw the rule entirely or perhaps remedy all the 

problems before finalizing it? 

Mr. HOLT. That is what I was trying to get at when I said I don’t 

see the reason to change this. If there is deficiency in how it has 

worked up to now, then we can talk about what changes might be 

needed. But I don’t see the deficiencies. 

Now, some people have said, for example, the six cities Harvard 

study that found deadly effects of small particulates was a flawed 

study, but most people don’t think it was a flawed study, and in 

fact, it has been verified in a variety of ways. And yet that has 

been the example that has been used for why we need a change 

in transparency, a change in procedures at EPA. 

So, unless I am convinced that what has been done is wrong and 

needs to be changed, I don’t see why we should have this or any 

variation on it. 

Senator CARPER. Mr. Chairman, thanks for allowing Dr. Holt to 

answer that question, and my thanks to Senator Booker for yielding his time to me. Thank you. 

Senator ROUNDS. Thank you, sir. 

At this time, I will turn to the full Committee Chairman, Senator 

Barrasso. 

Senator BARRASSO. Thank you, Senator Rounds. Thanks for holding this important hearing. 

Mr. Hahn, I was wondering. President Obama issued an executive order 7, 8 years ago, I think 2011, stating, he said regulations 

‘‘must be based on the best available science.’’ Does the EPA’s current proposed rule to strengthen the transparency of the Agency’s 

use of regulatory science, does this align with what President 

Obama asked for in 2011? 

Mr. HAHN. I don’t know exactly the text of what President 

Obama said, but to me, we all agree, there is consensus, that rules 

should be based on the best available science. And I would even go 

further and say we should roll rules out slowly so we can learn 

about what works and what doesn’t work, and do pilot studies and 

feed that back into our knowledge. 

The real issue is what is happening on the ground at agencies 

like EPA, HHS, independent agencies like the Federal Communications Commission, and that is kind of my wheelhouse, where we do 

benefit-cost analyses. We see that some of the regulations that 

come out of these agencies are incredibly beneficial, like seatbelt 

regulations, like the smoking regulation you talked about earlier, 

and some of them are not so beneficial, they are very expensive and 

actually don’t improve overall consumer welfare. 

So the short answer is yes, this rule, in my view, promotes the 

best available science, but I would like to see Congress more generally pushing in the direction of promoting evidence based policy. 

45 

Senator BARRASSO. Dr. Calabrese, your testimony notes a lot of 

health models currently used to inform regulatory decisions are 

based on data gathered 60 years ago. These models also use scientific assumption developed during that era. 

How have the advances in science and technology improved the 

scientific community’s ability to produce more accurate results and 

research? 

Mr. CALABRESE. There has been a wealth of scientific development since the first proposal for the use of LNT for cancer risk assessment back in 1956, and essentially what we have had since the 

1950s to the present time is really policy driving science. But we 

have such substantial scientific development that really has to be 

switched around, and science has to now drive policy. And my understanding of the dose response relationships in great detail is 

that the simplistic linearized model of the 1950s did not take into 

account the plethora of biology that we have today, and the regulatory agencies need to be flexible to the science and let science 

drive policy, rather than the other way around. 

Senator BARRASSO. Mr. Hahn, EPA’s proposal allows the Administrator to grant case by case waivers to use scientific studies 

which may not be able to meet the new transparency studies. Do 

you believe that the proposal’s waiver is an appropriate method to 

provide flexibility, while maintaining the strong transparency 

standards that we are looking for? 

Mr. HAHN. The short answer to your question is yes, but I 

haven’t thought carefully about other ways of doing that that could 

potentially be better. 

Senator BARRASSO. Dr. Calabrese, your testimony also states 

that hidden assumptions in the EPA’s secret science are often kind 

of silent drivers of regulatory action. Could you please describe how 

secret science can bias decisions made from a regulatory standpoint? 

Mr. CALABRESE. Yes. The so called what I call the secret type 

sciences is essentially you might have really excellent studies that 

deal with an animal model that has very little relevance to a 

human population, yet we assume that the human population is responding exactly like the information provided by the animal. So, 

the science can be great, but the relevance of a human population 

can be pretty much nil, and yet that is what the belief systems are 

based on, and regulations are based on, and there are a whole series of other specific examples like that. 

Senator BARRASSO. Thank you very much. 

Thank you, Mr. Chairman. 

Senator ROUNDS. Senator Booker. 

Senator BOOKER. I just want you to know, Mr. Chairman, I am 

not intimidated at all by going after the Chairman. He and I have 

a lot in common. He has a degree in science, biology, chemistry. I 

have a degree in science as well, political science. 

[Laughter.] 

Senator BARRASSO. And we are both left handed, as are several 

of the panelists today. It is a big day. 

Senator BOOKER. Yes. 

Senator BARRASSO. What about you, Carper? We have three left 

handers here and a couple left handers there. 

46 

Senator BOOKER. That is pretty good. That is pretty good. 

Dr. Holt, Mr. Hahn used a football analogy which was an appeal 

to my more baser qualifications for the job I am in, as a former 

football player, where he talked about moving the ball up the field 

or not. He said that is what this is about. 

Clearly, you want transparency. Clearly, you have talked about 

the urgency for transparency, the urgency for good science. But I 

just don’t think what is being clearly stated is that this very great 

tune of saying, hey, we want more transparency actually doesn’t 

move the ball forward; it actually is going to move the ball back 

and hurt, potentially, the health and well-being of folks. 

Could you succinctly explain one more time why such a proposed 

rule and the legislation actually could devastatingly hurt the safety 

and security of the American public? 

Mr. HOLT. The rule excludes the use of some kinds of research, 

and there are long lists of actual research or potentially relevant 

research that would be eliminated by any likely interpretation or 

application of this rule. I would direct the Senators to a letter I believe is available to you, I can certainly make it available to you, 

from the Emmett Environmental Law and Policy Clinic at Harvard 

Law School about the transparency rule. It is signed by presidents 

of hospitals and universities. They have a long list of valid research 

that they believe by any reasonable interpretation of this rule 

would be unusable in making regulatory policy. 

And as I said in my prepared remarks, if you don’t use all the 

good relevant science, people will be hurt. 

Senator BOOKER. Right. And so the fact that the majority of your 

membership organization has spoken out against this; the EPA’s 

own Science Advisory Board has spoken out against this; you have 

universities and other science folks saying don’t do this because 

you are going to exclude relevant science, you are going to undermine the safety of individuals because much of this is not 

replicable; all these things should scream to us that there is something wrong, even though the buzz words sound really good. 

I want to bring your attention to a strategy that was used by 

those industries that were trying to prevent health and safety 

standards that we take for example, cigarette smoking has been 

brought up. The EPA’s proposed rule sounds so much similar. This 

secret science rhetoric that was used by the tobacco industry is the 

same rhetoric that is being used right now. 

At the time, the tobacco industry lobbyists sought to create process based hurdles that would make it harder for agencies to establish guidelines and safeguards for secondhand smoke exposure. Rumored proposals would have prohibited the EPA from using a study 

unless it was considered replicable and all the underlying data in 

that study was released to the public. 

This is de ́ja` vu all over again, as another New Jerseyan once 

said. 

So here is industry—and this is the irony of this moment for 

me—is that you have industry working really hard to stop the 

transparency on things like the methane rule, on what we are seeing right now with the methylene chloride, and then on other areas 

they are trying to stop us regulating things just like we did with 

the tobacco industry. 

47 

You have been, obviously, down here for 16 years of your career. 

Do you see this double standard and hypocrisy being used to try 

to do things that hurt the public health when it benefits industry, 

and doing things that undermine science? 

Mr. HOLT. Well, in my testimony I talked about a likely motivation of the people who are proposing this because they are proposing it as part of a deregulatory regime, but I wanted to get beyond that because really what I wanted to talk about is not whether it is a double standard and what the motivation is, but what 

would the effect be. And this is not just me saying this; I mentioned this Environmental Law Clinic, but the Thoracic Medical Society, the American Geophysical Union, the American Chemical Society; many, many organizations and even far more individual scientists are saying the effect would be that science that we know 

to be good science would likely be excluded. 

Senator BOOKER. And just to make this last comment, exactly 

what you said is the issue with the methylene chloride, which people are dying from in the United States of America. It has been responsible for dozens of deaths. Under the TSCA law, bipartisan 

TSCA law, the EPA proposed a ban on methylene chloride in paint 

strippers in 2017, and in 2018 the Agency said it would finalize a 

rule, yet they haven’t acted. The scientific basis for the proposed 

ban on methylene chloride comes from an Agency risk assessment 

that received extensive interagency review and external peer review by independent scientists and relied on high quality studies 

but—and the point of here—the underlying case studies are not 

publicly available because of protecting information. 

So this is an example of what you are saying of how this would 

stop the banning of this chemical, which we know now needs to be 

banned; other nations have done it. 

So I would just like to submit for the record, Mr. Chairman, if 

I can ask unanimous consent to submit for the record comments 

and letters from the Boston University School of Public Health, the 

California Environmental Protection Agency, the Project on Government Oversight, the Environmental Defense Fund, the Natural 

Resource Defense Council, all demanding that the rule be withdrawn immediately, and the Ecological Society of America, which 

opposes the EPA’s rule. 

Senator ROUNDS. Without objection. 

[The referenced information follows:] 

48 


33371.030

Boston University School of Public Health 

Department of Environmental Health 

715 Albany Street 

Boston, Massachusetts 02118-2526 

T 617-358-2322 F 617-358-2642 

August 15, 2018 

By Electronic Submission to www.regulations.gov 

Acting Administrator Andrew Wheeler 

U.S. Environmental Protection Agency 

1200 Pennsylvania Avenue, NW 

Washington, D.C. 20460 

Docket lD No. EPA-HQ-OA-2018-0259 

Re: COMMENTS ON PROPOSED RULE, STRENGTHENING TRANSPARENCY IN 

REGULATORY SCIENCE, 83 FED. REG.18,768 (Apr. 30, 2018) 

Dear Acting Administrator Wheeler: 

We are submitting this letter to express our strong opposition to the proposed rule and to request 

that EPA withdraw it in its entirety. The authors and signatories of this letter are four members of 

the National Research Council (NRC) Committee on Improving Risk Analysis Approaches Used 

by the U.S. Environmental Protection Agency (EPA). This committee authored the report titled 

"Science and Decisions: Advancing Risk Assessment" [1]. We had the mandate to broadly 

consider how the EPA conducts risk assessment, including the questions of how dose response 

modeling should ideally be done, how uncertainty should be dealt with, and the scientific bases 

for and alternatives to default assumption choices in areas of uncertainty. Beyond our roles on 

the NRC committee, the authors have worked in academia, state government, and federal 

government, and collectively have substantial experience addressing the topics within this 

proposed rule. 

While we have objections to a number of elements ofthe proposed rule, many of which have 

been articulated in other letters [e.g., comments submitted by the International Society of 

Environmental Epidemiology (ID: EPA-HQ-OA-2018-0259-1973) and by Wendy Jacobs on 

behalf of signatories from Harvard (ID: EPA-HQ-OA-2018-0259-5418)]. within this letter we 

are focusing specifically on the paragraph that relates to transparency ofthe assumptions 

underlying dose response modeling. 

We have 4 primary objections related to this paragraph: 

I) The statement that "'there is growing empirical evidence of non-linearity in the 

concentration response function for specific pollutants and health effects" is vague, 

incorrect, and not supported by scientific evidence. 
49 


33371.031

2) The statement that "the use of default models, without consideration of alternatives or 

model uncertainty, can obscure the scientific justification for EPA actions" is incomplete, 

poorly defined, and does not reflect the necessity to make decisions based on uncertain 

information. 

3) The proposed rule is overly prescriptive regarding the modeling approaches that should 

be applied, demonstrates misunderstanding of the concept of model uncertainty, and is 

vague about the responsible parties and implications of the rule. 

4) Setting aside the merits (or lack thereof) of the content within the paragraph, the 

proposed rule is not the appropriate mechanism to effect change in risk assessment 

modeling practice at the Agency. 

We expand upon each of these points below. 

1. The statement that "there is growing empirical evidence of non-linearity in the 

concentration response function for specific pollutants and health effects" is vague, 

incorrect, and not supported by scientific evidence. 

In Chapter 5 of"Science and Decisions", the committee directly confronted the issue of dose 

response or concentration response modeling and how to address vexing challenges related to 

linear or non-linear associations. However, upon careful review ofthe literature and 

developing a theoretical framework for dose response modeling, the committee reached the 

opposite conclusion- there is growing empirical evidence of low-dose linearity. For 

example, many studies of fine particulate matter (PM2s) health effects displayed linearity at 

low concentrations at the time "Science and Decisions" was published [2-4], and the 

empirical evidence has grown substantially since that time [5-1 0]. There is analogous 

literature showing low-dose non-cancer health effects of lead [11-13], ozone [7, 8, 14], and 

arsenic [ 15-17], among other pollutants. In fact, for multiple pollutants and health outcomes, 

evidence indicates that the slope at low dose may be greater than the slope at high dose- a 

so-called "supralinear" concentration response function [18]. The proposed rule uses the 

phrase "non-linearity", but without any further explanation, it is not clear if that is solely 

intended to indicate evidence of thresholds below which no health effects would be seen, or 

to also incorporate other non-linear concentration response functions (whether supralinear, 

sub linear but where health effects are seen at low concentrations, or other non-monotonic 

forms). 

A major conclusion of "Science and Decisions" was that people are exposed to numerous 

background processes and exposures that would tend to lead to low-dose linearity for many 

chemicals in question. In other words, people may be exposed to pharmaceuticals, food, 

endogenous chemicals, and other exposures that all operate similarly in the body as a given 

chemical. Furthermore, people vary greatly in their vulnerability to chemical exposures for a 

variety of reasons. If a single person were exposed to a chemical in isolation, there could be a 

level below which no health effects would be exhibited. But if many people were exposed to 

that chemical, and a host of other substances, it would be likely that population-level health 

effects would be seen at low concentrations. 

2 
50 


33371.032

The aforementioned statement in the proposed rule, which was provided without any 

footnotes or references from the scientific literature, is therefore unsubstantiated by empirical 

evidence and directly contradicted by the conclusions from an expert committee specifically 

convened by EPA to address this question. 

2. The statement that "the use of default models, without consideration of alternatives or 

model uncertainty, can obscure the scientific justification for EPA actions" is 

incomplete, poorly defined, and does not reflect the necessity to make decisions based 

on uncertain information. 

It is important to recognize at the outset that default models are intrinsic to risk assessment. 

Starting with the 1983 Red Book [ 19], which established the foundations of risk assessment, 

federal agencies were recommended to develop uniform inference guidelines to avoid the 

possibility of manipulation of risk assessment outcomes and to help to standardize risk 

assessment across chemicals, sites, and scenarios. These so-called "defaults" were intended 

to be the best choice in the absence of data to the contrary, based on a strong scientific 

foundation but ultimately requiring some science policy judgments. "Default" should 

therefore not be used as a pejorative term it simply reflects the best current scientific 

understanding at a time when a decision needs to be made, for an Agency facing many 

similar decisions on a regular basis. New scientific understanding will lead to methods that 

deviate from the defaults and may, in fact, lead to new defaults. 

"Science and Decisions" included specific discussion of the topic of defaults. The committee 

concurred with the challenges and complications related to the use of defaults, including the 

fact that ultimately any choice of defaults reflects a value judgment made by the Agency (i.e., 

regarding the degree to which the Agency balances errors of underestimation vs. errors of 

overestimation of risk). 

That said, the "default models" statement within the proposed rule is incomplete, not 

reflective of current EPA practice, and not reflective of the need for the Agency to regularly 

make decisions. First, default models are based on current scientific understanding -far from 

obscuring the scientific justification for decisions, they illuminate them. For example, EPA 

has a default scaling factor to go from animal to human doses, which is based on our 

understanding of allometric variation of physiological factors across mammals as well as 

empirical evidence [20]. Similarly, use oflinear extrapolation in cancer risk assessment 

reflects scientific insight about the mode of action of the compound. 

Further. the current process as articulated by EPA [20] is ample to cover this concern, as it 

calls for a full evaluation ofthe available scientific data prior to invoking defaults. Therefore. 

risk assessments typically involve a comprehensive discussion of the available evidence, for 

compounds under study and others with similar attributes, with default models and methods 

used in situations when decisions must be made in the face of inadequate data. Default 

methods and default assumptions provide a bridge from available data that may not support 

more complicated analyses to decisions that need to be made in a timely manner. 

3 
51 


33371.033

Risk assessments are continually striving for increased transparency so that the uncertainties 

are understood by all parties, but this does not require engaging in a range of alternative 

approaches for which there is no obvious preference or scientific support. Defimlt models and 

assumptions, where necessary, provide risk assessments with a uniform approach in the face 

of uncertainty rather than having to deal with many competing risk assessments on the same 

topic. How does this obscure the scientific justification for action? 

In fact, presenting numerous alternative models, without some logical and consistent 

rationale for choosing among them, would obscure the ability to compare risk assessments 

and keep the Agency from making even the most basic decisions. The "Science and 

Decisions" committee grappled with this question and concluded that "the goal is not to 

present the multitude of possible risk estimates exhaustively but to present a small number of 

exemplar, plausible cases to provide the risk manager a context for understanding additional 

uncertainty contributed by considering assumptions other than the default" [I]. The proposed 

rule as written does not reflect this measured perspective. 

3. The proposed rule is overly prescriptive regarding the modeling approaches that should 

be applied, demonstrates misunderstanding of the concept of model uncertainty, and is 

vague about the responsible parties and implications of the rule. 

The proposed rule is quite specific about the concentration response modeling approaches 

that should be applied, including "a broad class of parametric concentration response models 

with a robust set of potential confounding variables; non parametric models that incorporate 

fewer assumptions; various threshold models across the exposure range; and spatial 

heterogeneity". While it is not directly stated, this component of the proposed rule relates to 

epidemiological studies, and more specifically, appears to target air pollution epidemiology. 

As articulated elsewhere [e.g., comments submitted by the International Society of 

Environmental Epidemiology (ID: EPA-HQ-OA-2018-0259-1973)], this prescriptive 

modeling approach is not reflective of best scientific practice. By following this approach, 

EPA would place greater weight on studies that force the data into shapes that may not be 

indicated by the data (i.e., by using defined parametric models and threshold models). This 

might potentially prioritize studies which report a range of statistical approaches even if they 

yield poorly fitting curves, as compared to a study which uses a widely-accepted nonparametric modeling approach that performs well. This is a far cry from "transparency". 

Similarly, the call to consider spatial heterogeneity is largely pertinent to only national-scale 

air pollution epidemiology, and does not consider whether such an analysis is indicated by 

the study design and available data. More broadly, it is not clear what is meant by "should 

give appropriate consideration"- does this mean EPA should not use studies lacking these 

attributes when making regulatory decisions? Given that most journal articles would not 

include such a wide range of models, is EPA proposing that individual researchers should 

produce additional models and provide them to EPA, or that EPA plans to reanalyze studies 

to fit these specific criteria? 

4 
52 


33371.034

Similarly, fitting numerous specified curves to toxicological study data ("including linear, 

threshold, and U-shaped, J-shaped, and bell-shaped models") does not represent best 

scientific practice. Fitting major competing models where mechanistic model forms are 

suggested by the underlying data or understanding of chemical action is reasonable and 

supported by "Science and Decisions". However, while one can fit many curves to a set of 

data and show that the resulting risk estimates differ, this is not necessarily reflective of the 

true level of uncertainty and would thus further obscure the assessment and impede decisionmaking. There are two major issues. First, most available toxicological data sets do not have 

the resolution to differentiate among many different model forms that can have extremely 

different low-dose extrapolations. Many parametric model forms would fit the data equally 

well but result in a wide range of estimated risks. Second, where the data allow for such 

differentiation, those models that do not fit the data well should be down-weighted, and those 

models that are not mechanistically supported should not even be considered. Best scientific 

practice involves using model averaging, wherein numerous mechanistically justified models 

are fit and the better-fitting models receive a higher weight than more poorly-fitting models. 

While we are supportive of the concept of incorporating model uncertainty, simply fitting a 

prescribed list of models to a small number of observations just provides a list of varying risk 

numbers without any strong scientific basis or ability to move forward. This reflects a 

fundamental misunderstanding of the concept of model uncertainty, ignoring the fact that 

some models are better justified than others, either based on scientific theory or empirical 

evidence related to curve-fitting. The text is confusingly written and not well thought 

through, and would leave the Agency ill-prepared to conduct risk assessments. 

4. Setting aside the merits (or lack thereof) of the content within the paragraph, this 

proposed rule is not the appropriate mechanism to effect change in risk assessment 

modeling practice at the Agency. 

The science associated with dose response modeling within risk assessment, ranging from 

better understanding of biological mechanisms to statistical modeling and risk estimation 

methods, continues to evolve. Because of the complexity of risk assessment and the fact that 

it operates at the science-policy interface, EPA regularly seeks guidance from the National 

Academies on where the field is and where it is going [1, 19, 21, 22]. EPA also has the Risk 

Assessment Forum, where senior scientists grapple with ditlicult issues related to risk 

assessment to allow for consistent implementation across the Agency, as well as periodic 

reports and guidance documents that provide best practices for cancer and non-cancer risk 

assessment (e.g., https://www.epa.gov/risk!risk-assessment-guidelines). These all represent 

deliberative processes that carefully examine the state of the science and offer conclusions 

regarding best practices. In contrast, this paragraph within the proposed rule is highly 

prescriptive in a manner that would add very little that is constructive and would most serve 

to lengthen and delay the risk assessment process. If the Agency wishes to re-examine 

questions related to how uncertainty is best characterized in dose response modeling, there 

arc ample mechanisms to do so beyond a short paragraph with no citations tucked into a 

proposed "transparency'' ru I e. 
53 


33371.035

Conclusions 

Broadly, the "Science and Decisions" committee was clear that EPA's approach to dose response 

modeling needed to be changed to reflect growing scientific knowledge and the evolving needs 

of decision makers. But this section of the proposed rule does not reflect the conclusions from 

the NRC committee (or other standard mechanisms by which changes in modeling and risk 

assessment practice are typically promulgated), and instead proposes prescriptive steps that, if 

taken in aggregate, would delay the risk assessment process and confuse risk managers, 

ultimately leading to paralysis by analysis. 

The signatories of this letter affirm the value of transparency and agree that the question of how 

epidemiological or toxicological information is used by EPA risk assessors to inform decisions is 

an important and challenging one. But, an overly prescriptive and poorly defined list of modeling 

approaches will not either decrease or illuminate uncertainty, and will not provide the basis for 

the specific decisions that confront the Agency. It appears that the treatment of uncertainty here 

is meant specifically to undermine the basis for public health protective measures, rather than to 

better represent the information available. They are merely a recipe for obfuscation and delay. 

We would ask that the proposed rule be withdrawn. 

By: ?;.."~-

,,,.:<~-

Jonathan Levy, SeD 

Interim Chair and Professor, Department of Environmental Health 

Boston University School of Public Health 

715 Albany St., T4W 

Boston, MA 02118-2526 

Email: jonlevy0ibu.cdu 

Submitted on behalf of: 

John Bailer, PhD 

University Distinguished Professor and Chair 

Department of Statistics 

Miami University 

Oxford, OH 

6 
54 


33371.036

Thomas A. Burke, PhD, MPH 

Jacob I and Irene B. Fabrikant Professor and Chair in Health Risk and Society 

Director, Risk Sciences and Public Policy Institute 

Johns Hopkins University Bloomberg School of Public Health 

Baltimore, MD 

Gary Ginsberg, PhD 

Assistant Professor 

Yale School of Public Health 

New Haven, CT 

7 
55 


33371.037

References 

1. Committee on Improving Risk Analysis Approaches Used by the U.S. EPA. Science and 

Decisions: Advancing Risk Assessment. Washington, DC: National Academies Press, 

2008. 

2. Samoli E, Analitis A, Touloumi G, Schwartz J, Anderson HR, Sunyer J, Bisanti L, 

Zmirou D, Vonk JM, Pekkanen J, et al. Estimating the exposure-response relationships 

between particulate matter and mortality within the APHEA multicity project. Environ 

Health Perspect 2005, 113:88-95. 

3. Schwartz J, Laden F, Zanobetti A. The concentration-response relation between PM2.5 

and daily deaths. Environ Health Per~pect 2002, 110:1025-1029. 

4. Dominici F, McDermott A, Zeger SL, Samet JM. National maps of the effects of 

particulate matter on mortality: exploring geographical variation. Environ Health 

Perspect 2003, Ill :39-44. 

5. Lepeule J, Laden F, Dockery D, Schwartz J. Chronic exposure to fine particles and 

mortality: An extended follow-up of the Harvard Six Cities Study from 1974 to 2009. 

Environ Health Perspect 2012, 120:965-970. 

6. Shi LH, Zanobetti A, Kloog I, Coull BA, Koutrakis P, Melly SJ, Schwartz JD. Lowconcentration PMz.s and mortality: Estimating acute and chronic effects in a populationbased study. Environ Health Perspect 2016, 124:46-52. 

7. Di Q, Dai L, Wang Y, Zanobetti A, Choirat C, Schwartz JD, Dominici F. Association of 

short-term exposure to air pollution with mortality in older adults. lAMA 2017, 318:2446-

2456. 

8. Di Q, Dominici F, Schwartz JD. Air pollution and mortality in the Medicare population. 

N Eng/ JMed2017, 377:1498-1499. 

9. Villeneuve PJ, Weichenthal SA, Crouse D, Miller AB, ToT, Martin RV, van Donkelaar 

A, Wall C, Burnett RT. Long-term exposure to fine particulate matter air pollution and 

mortality among Canadian women. Epidemio/2015, 26:536-545. 

10. Crouse DL, Peters PA, van Donkelaar A, Goldberg MS, Villeneuve PJ, Brion 0, KhanS, 

Atari DO, Jerrett M, Pope CA, et al. Risk ofnonaccidental and cardiovascular mortality 

in relation to long-term exposure to low concentrations of tine particulate matter: a 

Canadian national-level cohort study. Environ Health Perspect 2012, 120:708-714. 

ll. Lanphear BP, Rauch S, Auinger P, Allen RW, Hornung RW. Low-level lead exposure 

and mortality in US adults: a population-based cohort study. Lancet Pub Health 2018, 

3:e177-e184. 

12. Lanphear BP, Hornung R, Khoury J, Yolton K, Baghurst P, Bellinger DC, Canfield RL, 

Dietrich KN, Bornschein R, Greene T, et al. Low-level environmental lead exposure and 

children's intellectual fi.mction: an international pooled analysis. Environ Health Perspect 

2005, 113:894-899. 

13. Surkan PJ, Zhang A, Trachtenberg F, Daniel DB, McKinlay S, Bellinger DC. 

Neuropsychological function in children with blood lead levels <I 0 microg/dL. 

Neurotoxico/2007, 28:1!70-1177. 

14. Bell ML, Peng RD, Dominici F: The exposure-response curve for ozone and risk of 

mortality and the adequacy of current ozone regulations. Environ Health Perspect 2006, 

114:532-536. 

8 
56 


33371.038

15. Ersboll AK, Monrad M, Sorensen M, Baastrup R, Hansen B, Bach FW, Tjonneland A, 

Overvad K, Raaschou-Nielsen 0. Low-level exposure to arsenic in drinking water and 

incidence rate of stroke: A cohort study in Denmark. Environ Int2018, 120:72-80. 

16. Almberg KS, Turyk ME, Jones RM, Rankin K, Freels S, Graber JM, Stayner LT. Arsenic 

in drinking water and adverse birth outcomes in Ohio. Environ Res 2017, 157:52-59. 

17. Gilbert-Diamond D, Emond JA, Baker ER, Karrick SA, Karagas MR. Relation between 

in utero arsenic exposure and birth outcomes in a cohort of mothers and their newborns 

from New Hampshire. Environ Health Perspect 2016, 124:1299-1307. 

18. Lanphear BP: Low-level toxicity of chemicals: No acceptable levels? PLoS Biol20 17, 

I 5: e2003 066. 

19. Committee on the Institutional Means for Assessment of Risks to Public Health. Risk 

Assessment in the Federal Government: Managing the Process. Washington, DC: 

National Academies Press, 1983. 

20. US Environmental Protection Agency: Guidelines for Carcinogen Risk Assessment. 

Washington, DC: Risk Assessment Forum; 2005. 

21. Committee on Risk Characterization. Understanding Risk: Informing Decisions in a 

Democratic Society. Washington, DC: National Academies Press, 1996. 

22. Committee on Toxicity Testing and Assessment of Environmental Agents. Toxici(F 

Testing in the 21st Century: A Vision and a Strategy. Washington, DC: National 

Academies Press, 2007. 

9 
57 


33371.039

CalEPA 

California Environmental 

Protection Agency 

August 16, 2018 

Andrew Wheeler, Acting Administrator 

Un~ed States Environmental Protection Agency 

1555 151

h Street, NW 

Washington D.C. 20005 

Edmund G. Brown Jr. 

Govornor 

Submitted Electronically 

Re: U.S. EPA Strengthening Transparency in Regulatory Science Proposal 

Docket No. EPA-HQ-OA-2018-0259 

Dear Acting Administrator Wheeler: 

The California Environmental Protection Agency (CaiEPA) submits the attached 

comments on the United States Environmental Protection Agency's (EPA) proposed 

"Strengthening Transparency in Regulatory Science" rule, (83 FR 18768 (April30, 

2018).) CaiEPA submits these comments on its own behalf and on behalf of the 

following California environmental prdeatlon <~gencies: the California Air Resources 

Board, the Office of Environmental Health Hazard Assessment, the Department of Toxic 

Substances Control, the Department of Pesticide Regulatkm and the State Water 

Resources Control Board, 

The proposed rule will not serve its purported purpose of guaranteeing that EPA relies 

on the best available science for its regulatory action. Instead, its requirement that all 

research data, methods and models for "pivotal" regulatory science must be made 

available to the public is unnecessary, impractical and will prevent EPA !nom 

considering the best available science in carrying out its mission to protect public health 

and the environment. CaiEPA and its constituent agencies urge EPA to abandon the 

proposed rule. 

Thank you for your consideration of the attached comments. 

Sincerely, utt'-

Matthew Rodriquez 

Secretary of California EPA 
58 


33371.040

COMMENTS OF CALIFORNIA ENVIRONMENTAL PROTECTION AGENCY, 

CALIFORNIA AIR RESOURCES BOARD, OFFICE OF ENVIRONMENTAL HEALTH 

HAZARD ASSESSEMENT, DEPARTMENT OF TOXIC SUBSTANCES CONTROL, 

DEPARTMENT OF PESTICIDE REGULATION AND STATE WATER RESOURCES 

CONTROL BOARD ON PROPOSED STRENGTHENING TRANSPARENCY 

IN REGULATORY SCIENCE RULE 

DOCKET No. EPA-HQ-OA-2018-0259 

INTRODUCTION 

The California Environmental Protection Agency (CaiEPA) submits the 

comments below on the proposed rule entitled "Strengthening Transparency in 

Regulatory Science" (83 Fed.Reg. 18768 (April30, 2018). CaiEPA submits these 

comments on its own behalf and on behalf of the following California environmental 

protection agencies: the California Air Resources Board (CARS), the Office of 

Environmental Health Hazard Assessment, the Department of Toxic Substances 

Control, the Department of Pesticide Regulation and the State Water Resources Control 

Board. 

The proposed rule purports to be directed toward enhancing the transparency 

and validity of the scientffic information relied upon by the U.S. Environmental 

Protections Agency (EPA) in order to strengthen the integrity of EPA's regulatory 

actions. (83 Fed. Reg. 18768.} The mechanism proposed to achieve this purported 

goal is to require that data and models underlying scientific studies that are "pivotal" to 

regulatory action must be made available to the public. (83 Fed. Reg. 18769.) 

High quality science is critical to EPA's mission to protect human health and the 

environment. EPA must rely on science to understand the nature and relative risks of 

threats to human health and the environment, including the populations likely to be 

affected by any threats, the circumstances and levels of exposure to risks at which harm 

to human health or the environment have occurred or are likely to occur, and the 

methods and techniques that can be used to reduce or eliminate harm to human health 

or the environment. 

However, the proposed rule would prevent EPA's consideration of relevant, high 

quality, important science and appears to be directed to that end. It is based on a 

fundamentally flawed assumption: that a threshold criterion for determining the merit of 

scientific research is that all raw data and research methods are made available to the 

public. The proposed rule does not explain why this criterion should take precedence 

over all other criteria that are used in the scientific community to evaluate the merit of 

scientific research, and it ignores well-established reasons that some high quality 

scientific data and research methods cannot be made available to the public. It also 

fails to explain why the consistent use of existing methods for evaluating scientific 
59 


33371.041

research, including peer review and EPA's scientific advisory panels, is insufficient to 

ensure that EPA relies on the best available science for its regulatory actions. 

There is no reason to codify the proposed rule's exclusionary regulatory 

requirement If adopted, the proposed rule would only endanger and impede EPA's 

mission to protect public health and the environment EPA should abandon the 

proposed rule. 

I. The Proposed Rule is Based on a Faulty Premise Regarding the Determinants of 

Research Quality. 

We agree that scientific research should be transparent regarding methods used 

to collect, analyze and interpret data, and transparent regarding the results and 

conclusions derived from analysis and interpretation of date. Indeed, scientists are 

trained in assessing research according to all of these criteria. 1 The proposed rule 

deviates from accepted standards used by the scientific community to assess the 

validity of research. The scientific community applies a/1 of these criteria, and applies 

them even when not all data can be made publically available for a variety of reasons. 

These reasons include but are not limited to the confidential nature of personal health 

infonnation, the confidential nature of business information, and the confidential nature 

of proprietary intellectual property. Notwithstanding these well-established protections 

for some raw data and research methods, the scientific community regularly assesses 

the merits of scientific research. The proposed rule advances no reason why the 

accepted methods used in the scientific community to evaluate scientific research 

should be replaced with the single, threshold requirement in the proposed rule. 

The proposed rule also deviates from accepted practices that EPA routinely 

uses, and is required to use, to evaluate science it relies on for regulatory decisions. 

EPA has long recognized that proprietary "confidential business infonnation" submitted 

to it cannot be shared with the public, yet it routinely relies on that infonnation, 

including scientific studies and other scientific information, as the foundation for 

important regulatory decisions. (See, e.g., confidential business information protection 

provisions in the Toxic Substances Control Act at 15 U.S.C. § 2613, subd. (c), and in 

the Federal Insecticide, Fungicide and Rodenticide Act at 7 U.S. C. 136h, subd. (b).) 

EPA also adheres to specific Congressional directives regarding the science it should 

consider for regulatory action, including directives to consider whether the scientific 

information is reasonable, clear, complete and whether it has been peer reviewed. 

(See, e.g., the Toxic Substances Control Act at 15 U.S.C. § 2625, subds. (h) and (i), 

requiring EPA to consider several factors to evaluate science relating to toxic 

chemicals and requiring that decisions be based on "the weight of the scientific 

evidence," and the Clean Air Act at 42 U.S.C. § 7408, subd. (a)(2), requiring EPA to 

rely on "the best available, peer-reviewed science and supporting studies conducted in 

accordance \Nith sound and objective scientific practices.") 

1 J. Berg, P. Campbell, V. Keirmer, N. Raikhel, D. Sweet, "Joint Statement on EPA Proposed 

Rule and Public Availability of Data; Science, April 30, 2018. 

2 
60 


33371.042

The fact that the proposed rule is at odds with the manner in which the scientific 

community evaluates research-underscored by the large number of comments 

submitted in opposition to the rule by scientists, scientific organizations, and scientific 

journals-and also at odds with methods EPA uses and is required to use to evaluate 

scientific information suggests that the proposed rule's true purpose is other than to 

ensure that EPA relies on the "best available science." Instead, the true purpose 

appears to be to exclude from EPA's consideration scientific research that might 

support a need for rigorous regulatory action. That purpose is unacceptable, unlawful, 

and contrary to EPA's mission and duty to protect human health and the environment. 

EPA should continue to use of the comprehensive criteria used by the scientific 

community (and historically used by EPA) to evaluate scientific research. 

tl. The Proposed Rule is Unnecessary Because Existing Procedures Assure that 

EPA's Regulatory Actions are Based on the Best Available Science. 

The proposed rule does not contain an explanation of the necessity for the rule. 

There are no references to regulations adopted by EPA where a subsequent review of 

the data or models used in scientific research has revealed that they did not support the 

regulatory action or were falsified. Neither is there any suggestion that EPA has relied 

on flawed scientific methods as the basis for regulatory action, or that public 

unavailability of data or research methods has resulted in irrational or arbitrary 

regulations. 

The lack of any explanation for a need for the proposed rule is doubtress 

because procedures are already in place that assure use of the best available science 

for EPA's regulatory activity. These procedures include the Scientific Advisory Board 

established by Congress in 1978 to advise on scientific matters (42 U.S.C. § 4365.), 

existing independent peer review of much of the scientific research relied on tor 

regulatory action, and legal requirements that prohibit EPA's adoption of regulations that 

are arbitrary, capricious or unsupported by substantial evidence (e.g. 5 U.S.C. §. 706). 

When consistently implemented, these procedures and requirements, among others, 

assure that EPA's regulatory actions are based on the best available science and cast 

substantial doubt that the true purpose of this rulemaking has anything to do with 

strengthening the validity of regulatory science. 

Congress created the Scientific Advisory Board (SAB) to provide the 

Administrator with scientific advice. (42 U.S.C. § 4365.) The SAB is required by its 

authorizing legislation to make every effort to maximize public participation and 

transparency, "including making the scientific and technical advice of the [SAB] and any 

investigative panels ... publically available in electronic form on the website of the 

Environmental Protection Agency." (Ibid.) The proposed rule does not mention the 

SAB, or its important function in providing expert assessments of whether scientific 

research offered as tile basis for regulatory action is, in fact, the best available science. 

In another telling signal about the proposed rule's true purpose, EPA did not even 

3 
61 


33371.043

consult with the SA B-its own scientific experts-regarding the proposed rule's 

provisions and has ignored the SAB's objections to the proposal.2 

The proposed rule also ignores that much of the scientific research considered in 

the regulatory context, and all research published in reputable journals, has already 

been subject to extensive peer review. While the proposed rule would place judgments 

regarding the science that EPA may use in the hands of political appointees-wiH1 its 

suggestion of an ad hoc mechanism for making exceptions to the rule's limitations-the 

method that is accepted in the scientific community for assessment of the strength of 

scientific research is peer review, The fact that scientific studies are regularly peer 

reviewed, including peer review by expert panels such as the SAB, renders the 

proposed rule unnecessary. 

The process for establishing National Ambient Air Quality Standards (NAAQS) 

illustrates the scientific review procedures that are already in place for EPA's regulatory 

actions. In the NAAQS process, the research results that are given the most weight are 

from the peer-reviewed literature. After EPA staff and their contractors review the 

literature, the Clean Air Scientific Advisory Committee of the SAB, which consists of 

internationally recognized experts in their scientific disciplines, reviews the EPA staff 

reports. The Committee provides advice to the Administrator regarding the adequacy of 

current standards and recommendations for revisions, if necessary for the protection of 

public health. The EPA staff reports also receive public comment, including from 

independent and industry scientists, and the Committee review includes consideration 

of those public comments. EPA NAAQS documents typically receive multiple rounds of 

expert scientific review before they are finalized. 

The ultimate safeguard to assure that EPA regulatory action is based on highquality science is the fact that EPA's regulatory action is subject to the notice and 

comment requirements of the Administrative Procedure Act (APA, 5 U.S.C. § 553) and 

ultimately to judicial review. To the extent that scientific information proposed as a 

basis for regulatory action falls short, the APA provides members of the public, 

regulated businesses and other scientists an opportunity to comment to the agency 

about those shortcomings and to submit contrary studies and information for agency 

consideration. (Ibid.) Following adoption of a regulation, interested parties may seek 

judicial review to determine whether it is arbitrary, capricious or lacking in evidentiary 

support. (5 U.S.C. § 706.) The APA requirements, and the opportunity for judicial 

review of EPA's regulatory action, protect against the adoption of regulations that lack 

high-quality scientific support. An additional rule is not required. 

'See Letter from Michael Honeycutt, Chair, Science Advisory Board, et al., to Scott Pruitt, 

Administrator, U.S. EPA (June 28, 2018), available at 

https:l/yosemite.epa.gov/sab/sabQ.rmil!f1.02flloopupWedReportslastonthBOARDl4_1;.Q!l44CA2 

8936083852582BB004ADE54/$File/EPA-SAB-j_8-003+Unsigned.pdf 

4 
62 


33371.044

Ill. The Proposed Rule Would Eliminate Important Scientific Research from EPA's 

Consideration to the Detriment of Effective Protection of Human Health and The 

Environment and Establish a Disincentive for Innovative Research. 

As set forth above, the apparent purpose of the proposed rule is to exclude highquality scientific research from being considered by EPA, because it might point to the 

need for regulatory action. The examples below highlight research that EPA would likely 

not be required or permitted to consider if the proposed rule is adopted:3 

A. The proposed rule would exclude vital epidemiological studies from 

EPA's consideration. 

Many of the key studies likely to be affected by the proposed rule, if finalized, are 

long-term cohort epidemiological studies that have been integral to setting standards 

that protect public health and the environment, but for which raw data cannot legally or 

ethically be published. This prominently includes the NMOS, particularly given the 

iterative nature of NAAQS administrative record reviews and EPA's specific solicitation 

of comment about retrospective application of the proposed rule to these reviews (83 

Fed.Reg. at 18772). 

EPA assesses the potential for adverse health impacts associated with air 

pollutants as part of setting NAAQS. Epidemiological studies reveal the links between 

pollutant exposure and adverse health effects. The Harvard Six Cities study of over 

8,000 people4 and the American Cancer Society study of over 500,000 people,5 in 

particular, have demonstrated the association between particulate matter (less than 2.5 

microns) exposures and premature mortality. A more recent study of 61 million 

Medicate recipients found adverse health effects associated with particulate exposure 

below the current standardH These studies rely on confidential information about each 

-----······--··-· 

' As discussed below, the proposed regulatory text would allow the Administrator to exempt 

studies from the rule ''if he or she determines that compliance is impracticable because: (a) It is 

not feasible to ensure that all dose response data and models underlying pivotal regulatory 

science is publicly available in a manner sufficient for independent validation, in a fashion that is 

consistent with law, protects privacy, confidentiality, confidential business information, and is 

sensitive to national and homeland security[.]" 83 FRat 18774. However, this exemption 

seems designed to allow EPA to avoid publishing dose response data and models on which the 

agency's "pivotal regulatory science" has already relied, rather than allowing EPA to base 

regulatory decisions on data that cannot be made publicly available. 

• Johanna Lepeule, Francine Laden, Douglas Dockery, and Joel Schwartz. Chronic Exposure to 

Fine Particles and Mortality: An Extended Follow-up of the Harvard Six Cities Study from 1 97 4 

to 2009. Environmental Health Perspectives 2012. 120(7): 965-970. 5 C. Arden Pope, Ill, PhD, Richard T. Burnett, PhD, Michael J. Thun, MD, Eugenia E. Calle, 

PhD, Daniel Krewski, PhD, Kazuhiko Ito, PhD, and George D. Thurston, SeD. Lung Cancer, 

Cardiopulmonary Mortality, and Long-term Exposure to Fine Particulate Air Pollution. JAMA. 

2002 Mar6; 287(9): 1132-1141. 6 Qian Di, M.S., Yan Wang, M.S., Antonella Zanobetti, Ph.D., Yan Wang, Ph.D., Petros 

Koutrakis, Ph.D., Christine Choirat, Ph.D., Fransecsa Dominci, Ph.D. and Joel Schwartz, Ph.D., 

5 
63 


33371.045

person in the cohort. This information includes employment history, medical history, 

and alcohol and drug use. Validation of the study's conclusions would require re-I inking 

of data sets containing individually identifiable health information. For example, 

residence data needs to be paired with birth and death dates, and related health 

condition or lifestyle data (e.g. smoking habits) to isolate the effect of air pollution levels 

on the mortality rates of populations in different cities. Insisting such data be "publically 

available" is a violation of the Health Insurance Portability and Accountability Act of 

1996 (HIPAA). The proposed rule would either require publishing data so thoroughly 

redacted as to be effectively useless for validation, or, more likely and more in keeping 

with the rule's apparent actual purpose, preclude EPA from considering these studies 

and others like them in the NAAQS standard-setting process. EPA's failure to consider 

individual health data-because it cannot be made public-would miss important data 

regarding particularly vulnerable populations that the NAAQS were developed to 

protect. The ultimate result would be weakened NAAQS standards that would not rely 

on the best available science. 

The proposed rule would also imperil vital health protections that relate to 

ensuring clean water. Epidemiological studies that EPA could not consider under the 

proposed rule include studies related to fecal indicator bacteria concentrations and 

water-content recreation at ocean and freshwater beaches. These studies of people 

swimming, wading, surfing and contacting water at beaches include individual 

participant enrollment in the studies and follow-up to gather private medical data to 

estimate dose-related responses. This type of epidemiological data was used in EPA's 

Clean Water Act section 304(a) criteria (33 U.S.C. § 1314(a)), including EPA's 2012 

Recreation Water Quality Criteria,? which is a foundation document for the California 

State Water Board's proposed bacterial water quality objectives. 

The proposed rule would also likely prevent EPA from considering 

epidemiological studies of children exposed in utero to mercury through maternal 

consumption of mercury-contaminated fish or marine animals because individual health 

data could not be made public. EPA used these epidemiological studies in its 2001 

report, Water Criterion for the Protection of Human Health: Methylmercury, 8 which 

served as a basis for the California State Water Board's recently adopted mercury water 

quality objectives. 

Other examples of vital research that would likely be excluded from consideration 

by the proposed rule include toxicity criteria for lead, arsenic and vinyl chloride, amongst 

other chemical agents, as well as biomonitoring studies that identify the presence of 

Air pollution and Mortality in the Medicare Population, New England Journal of Medicine 2017, 

376 (26) 2513-2522. 1 No. EPA-820-F-12-058, available at ]Jllil.§://www.epa.gov/siteslproductions!files{2015.: 

1 Oldocumentslrwgc2012.df 

'No. EPA-823-R-01-001, available at 

.tlt\p_pjlnepis.epa,ggyLE,;!:\§li.f:YE'_\.l8.l,"cgi?Dockey=20003UU4.TXT 

6 
64 


33371.046

chemicals in human subjects. All of this research is based on personal raw data that 

cannot be provided to the public, 

Protection of public health and the environment requires that EPA not adopt an 

unnecessary regulatory requirement that would prevent its consideration of vital 

epidemiological studies. 

B. The proposed rule would exclude large amounts of animal studies from 

EPA's consideration and important data regarding chemical exposures. 

A large toxicological literature based on animal studies has accrued over the past 

60 years that underlies the establishment of advisory levels and standards for hundreds 

of chemicals, including drinking water maximum contaminant levels, soil clean-up 

targets, hazardous air pollutants reference levels, water quality levels for establishing 

permits, pesticide registration decisions. In the scientific studies relied on for 

establishing these levels, data are generally provided in aggregated form due to journal 

page count limitations. Certain raw study data are available at an individual animal level 

(e.g., pathology data) online and from animal study reports performed by the National 

Toxicology Program (NTP), but such data are not included in study reports published by 

academic and industry researchers in peer-reviewed journals. 

The proposed regulation would preclude EPA from considering a large number 

of these important, peer-reviewed animal studies- studies that should serve as a 

foundation for regulatory action-- merely because of the unavailability of the raw data 

underlying the studies or the time and expense that would be required to obtain the raw 

data and provide it to the public. Further, a requirement to obtain an ad hoc exception 

to the proposed rule's requirements for farge numbers of animal studies would be wholly 

unworkable. Again, the ultimate result of the proposed rule's requirements as applied to 

animal studies would be that EPA would not consider peer-reviewed, high-quality 

research that has been accepted in the scientific community. 

C. The proposed rule would exclude innovative academic research from 

EPA's consideration. 

For scientists at academic and research institutions, intellectual property 

protections for innovative analytical tools, models, and computer code are vital to 

scientific achievement and career advancement. Section 30.5(c) of the proposed rule, 

however, would require the publication of all details of such original models and code. 

Moreover , intellectual property is absent from the list of potential exceptions to the data 

publication requirements in proposed section 30.5 and bases for exemptions in 

proposed section 30.9, both of which suggest (without any detail) protections only for 

privacy, confidentiality, confidential business information, and national and homeland 

security. 

This lack of protection for intellectual property would thwart innovation and/or prevent 

the consideration of newer tools and models in EPA's regulatory decision-making. 

7 
65 


33371.047

Additionally, industry research might still be protected as confidential business 

information, while academic or public interest research would not be entitled to rely on 

intellectual property protections. The absence of publication exceptions or exemptions 

for protected intellectual property makes it far more likely that industry research, rather 

than academic or public interest research, would form the basis of regulatory decisionmaking. This could build an industry preference into EPA's regulatory process. 

D. The proposed rule would exclude high-quality meta-analyses from 

EPA's consideration. 

The proposed rule would also substantially affect EPA's ability to consider high 

quality meta-analyses. Meta-analyses incorporate the results from multiple studies on 

the same topic, and can be most informative when using data sets with information at 

the individual level. If studies using individual data are excluded because of 

confidentiality and disclosure concerns, there will be concern for the validity of high 

quality meta-analyses that incorporate data from individual studies. 

E. The proposed rule is likely to exclude high-quality CARS-funded 

research from EPA's consideration. 

Over the past two decades, CARS has funded more than 460 research contracts, 

which have resulted in a similar number of peer-reviewed, highly cited publications in 

high-impact journals. On average, other articles cite these CARS-funded publications 

about 82 times each, and approximately 80 percent are published in the top quartile of 

journals in terms of scientific impact, which compares favorably to publications funded 

by other organizations such as the EPA and the Health Effects Institute. Publications 

on health and exposure, atmospheric science, and emissions monitoring and control 

have received the most citations, and reflect CARS's long-standing research strengths. 

CARB research also has been cited in reviews of the NMOS and in dozens of CARB 

regulatory documents. Publications resulting from CARS research contracts have won 

multiple Haagen-Smit Prizes for outstanding papers published in the journal 

Atmospheric Environment, the John Johnson award for outstanding research in diesel 

engines from the SAE International Journal of Engines, and the Arthur C. Stern 

Distinguished Paper award from the Journal of the Air and Waste Management 

Association.9 

A significant number of the studies that CARS supports are 

epidemiological/cohort studies that the proposed rule is likely to preclude from EPA 

consideration in its regulatory decision making for the reasons discussed above. These 

likely include: 

-----------

9 CARS 2018. Proposed Triennial Strategic Research Plan Fiscal Years 2018-2021, 

https://ww2. arb.ca. gov/sites/defa ul!/files/20 18-04/FY2018-21_ Triennial_ Research_Pian-2018-

04-24.pdf' p. 9. 

8 
66 


33371.048

- The 1 0-year Children's Health Study (CHS) initiated in 1993, which was the first 

major study to assess the impacts of long-term air pollution exposure on the 

respiratory health of California's children.1

° Following 5,500 students in 12 

southern California communities from fourth grade through high school, this 

study revealed the extent to which ozone, nitrogen dioxide, acid vapors 

consisting of nitric acid and hydrogen chloride, and particulate matter affect 

children's lung development. The results of this study are evidence for 

classifying children as sensitive receptors to air pollution and have influenced 

research since and shaped California legislation addressing children's 

microenvironments.11 

- The Los Angeles Family and Neighborhood Survey (LAFANS), a study of 

families in different neighborhoods in Los Angeles County. 12 The researchers 

found that children more highly exposed to traffic pollution were 30-40 percent 

more likely to report wheeze symptoms.13 

10 Peters, J.M., et al. (1999) "A study of twelve Southern California communities with differing 

levels and types of air pollution. II. Effects on pulmonary function," American Journal of 

Respiratory and Critical Care Medicine. 159: 768-775; Avol, E.L., et al. (2001) "Respiratory 

effects of relocating to areas of differing air pollution levels,' American Journal of Respiratory 

and Critical Care Medicine, 164: 2067-2072; Gauderman, W.J., et al. (2002) "Association 

between air pollution and lung function growth in Southern California children: Results from a 

second cohort," American Journal of Respiratory and Critical Care Medicine, 166(1 ): 74-84; 

McConnell, R., et al. (2002) "Asthma in exercising children exposed to ozone: A cohort study,'' 

Lancet, 359: 386-391; Gauderman, W.J., et al. (2004) "The effect of air pollution on lung 

development from 10 to 18 years of age,' New England Journal of Medicine 351 (11 ): 1057-

1067; Gauderman, W. J., et al. {2005) "Childhood asthma and exposure to traffic and nitrogen 

dioxide," Epidemiology 16:737-743; McConnell, R., et al. (2006) "Traffic, susceptibility, and 

childhood asthma,' Environmental Health Perspectives 114:766-772; Gauderman, W. J., et al. 

(2007) "Effect of exposure to traffic on lung development from 10 to 18 years of age: a cohort 

study," Lancet 369:571-577; Gauderman, W.J., et al. (2015) "Association of improved air quality 

with lung development in children" New England Journal of Medicine 372(1 0):905-913; 

Berhane, K. et al. (2016) "Association of changes in air quality with bronchitic symptoms in 

children in California, 1 993-2012", Journal of the American Medical Association, 315( 14 ): 1491-

1501. 

11 GARB 2018. Proposed Triennial Strategic Research Plan Fiscal Years 2018-2021, 

https://ww2.arb.ca.gov/sitesldefault!files/2018-04/FY2018-21_ Triennial_ Research _Pian-20 18-

04-24.pdf' pp. 6, 15. 12 Ritz, Bet al. (2009) ;'Traffic-Related Air Pollution and Asthma in Economically Disadvantaged 

and High Traffic Density Neighborhoods in Los Angeles County, California" Final Report ARB 

Contract No. 04-323 Prepared for the California Air Resources Board and California 

Environmental Protection Agency Sacramento, CA. 

13 GARB 2018. Proposed Triennial Strategic Research Plan Fiscal Years 2018-2021, 

https:/lww2.arb.ca.gov/sites/defaultlfiles/20 18-04/FY20 18-21_ Trienniai_Research _Pian-20 18-

04-24.pdf' p. 15. 

9 
67 


33371.049

The East Bay Kids Study14 and the California Health Interview Survey (CHIS),15 

which sought to determine impacts of pollution levels and greater sensitivity in 

low-income neighborhoods on asthma, including in the CHIS study, on whether 

the asthma burden disparity is due to exposure to higher levels of air pollutants, 

greater vulnerability, or both. Findings from these studies have helped to inform 

policy decisions on motor vehicle emissions control and enforcement, and 

asthma prevention, control, and education in low socioeconomic status 

populations. 16 

IV. There are No Provisions That Could be Included In the Proposed Rule that 

Would Make it Workable or Effective to Assure that EPA Relies on the Best 

Available Science. 

EPA's notice of the proposed rule solicits comments on which criteria it should 

base exceptions to the rule, including whether case-by-case exceptions to the rule may 

be appropriate. Because the underlying premise of the rule is flawed and the rule is 

unnecessary, unlawful, arbitrary, and harmful, we decline to provide suggestions for 

methods to determine exceptions to the rule. There are no criteria or ad hoc methods 

for making exceptions to the rule that would not pose an unnecessary risk of 

constraining use of the best available science to make regulatory decisions, particularly 

where political appointees rather than expert scientific panels, such as the SAB, would 

apply the criteria or make the ad hoc determinations. 

Additionally there are no criteria or ad hoc methods that would prevent stalling 

vital decisions to protect public health and the environment by "analysis paralysis." The 

proposed rule, if adopted, would inevitably delay setting protective standards through 

prolonged evaluation of the sufficiency of the public availability of research data and 

methods, rather than evaluation of the actual quality and import of scientific research. A 

related likely consequence of the proposed rule, even if it contains ad hoc mechanisms 

for exceptions, is a reduction in EPA's ability to respond quickly to emerging challenges, 

when data and models toke time to be made publicly available and/or redacted and 

otherwise prepared in a format appropriate for public review. 

EPA suggests the following methods to protect privacy, confidentiality, security, 

and other necessary interests: "simple data masking, coding, and de·identification 

techniques"; "[r]equiring applications for access; restricting access to data for the 

purposes of replication, validation, and sensitivity evaluation; establishing physical 

controls on data storage; online training for researchers; and nondisclosure 

1' Kim, J., et al. (2008) "Residential Traffic and Children's Respiratory Health." Environmental 

Health Perspectives 116.9 (2008): 1274·1279. 15 Meng, Y-Y., et al. (2012) "Is Disparity in Asthma among Californians due to Higher Pollution 

Exposures. Greater Vulnerability, or Both?" Final Report ARB Contract No: 07-309 Prepared for 

the California Air Resources Board and the California Environmental Protection Agency. 1a GARB 2018. Proposed Triennial Strategic Research Plan Fiscal Years 2018-2021, 

https://ww2.a rb.ca.gov/sites/defauiVfiles/20 18-04/FY2018-21_ Trienniai_Research _Pian-20 18-

04-24.pdf' p. 22. 

10 
68 


33371.050

agreements." (83 Fed. Reg. at 18771.) Each of these proposed strategies is insufficient 

to protect privacy and confidentiality, and also a waste of time and resources because 

the underlying proposed rule is unnecessary in the first place. Further, these 

suggestions presume resources that EPA does not commit. EPA's failure to prepare a 

Regulatory Impact Analysis, or attempt to estimate the significant expenses that would 

be required to prepare, redact, and make public vast amounts of data-as it would have 

to do in order to actually base regulatory decisions on the best available sciencesuggests that EPA does not intend to take on any burdens associated with the 

proposed rule, including burdens attendant to data masking, coding·and deidentification techniques. 17 The lack of any commitment to fund implementation of 

procedures to protect privacy, confidentiality, security and other interests would privilege 

industry science, where funds would be available to comply with the proposed rule's 

requirements, and would exclude robust academic and other science from EPA's 

consideration only because of insufficient funds to comply with the proposed rule's 

onerous and unnecessary requirements. 

Data masking, coding, and other procedures suggested to protect privacy, 

particularly in the context of epidemiological research, also would not work. Even when 

medical data is masked or coded, subjects can be identified if the sample size is small 

enough, the characteristics described are rare enough, and/or the data includes, for 

example, subjects' family structure, geographic location, dates of birth, sex/gender, 

medical conditions, occupations, and/or dates and causes of death. The fact that the 

public would be able to de-anonymize much epidemiological data, after de-identification 

processes have been applied, would almost certainly have a chilling effect on voluntary 

public participation in important research. It would also prevent EPA from relying on the 

"best available science'' in carrying out its work. 

V. The Proposed Rule Undermines Established Principles and Practices in its 

Approach to Dose Response Modeling, and Would Result in Delays in 

Completion of Risk Assessments. 

The proposed rule includes particular focus on dose response models and 

default assumptions used in those models. The need for default approaches in risk 

assessments has long been recognized as necessary to select among inference options 

in the presence of uncertainty. It has also been long recognized that there can be 

compelling scientific evidence for taking an alternative approach to a default in a 

17 U.S. EPA does not acknowledge or attempt to justify its failure to prepare a Regulatory Impact 

Analysis or otherwise estimate the benefits and burdens of the proposal, saying only: "One 

recent analysis found that: 'Improvements in reproducibility can be thought of as increasing the 

net benefits of regulation because they would avoid situations in which costs or benefits are 

wrongly estimated to occur or in which regulatory costs are imposed without corresponding 

benefits ... .' They concluded that 'an increase in existing net benefits from greater 

reproducibility, which, if it occurred, would cover the costs of obtaining the data and making the 

data available." 83 Fed.Reg. at 18772, citing https://www.mercatus.org/systemlfiles/ MercatusLutter-Public-Access-Data-v3.pdf.Securily. 

II 
69 


33371.051

scientific analysis. The National Academy of Sciences has reviewed this approach to 

defaults throughout the years, 18 and the need for default approaches to perform 

assessments absent compelling science to the contrary has been established. EPA has 

therefore developed a series of practices, handbooks and guidance documents over the 

years that guide the development of risk assessments. Further, as the science has 

developed, these practice and guidance documents have been updated following 

lengthy review and discussion. Individual EPA documents also undergo extensive 

internal and external scientific peer review. The result is a canon that guides the 

development of analyses and against which the analyses are judged. 

In this context, we make the following observations about the proposed rule's 

provisions regarding dose response modeling data: 

• Requiring justification for all default assumptions ignores establishment of 

defaults through prior public processes and external public peer reviews. 

Requiring EPA to justify the use of default assumptions for every toxicity health 

factor derivation ignores the detailed development process of those default 

assumptions. Those default assumptions were developed in several EPA 

documents (including the 2005 Guidelines for Carcinogen Risk Assessment19), 

which received public comment and extensive external peer-review. Requiring 

EPA to rejustify those default assumptions every time they are used, as the 

proposed rule suggests, would serve no purpose other than to add unnecessary 

delay to risk assessments and regulatory action. 

• The approach to non-linear cancer dose-response modeling suggested by the 

proposed rule is inconsistent with scientific guidance for detenmining when 

defaults can be replaced by alternative modeling approaches that are backed by 

chemical-specific data. 

• The requirement for sensitivity analysis for all alternative-modeling assumptions 

does not require an evaluation of the scientific validity of those models. The 

proposed rule's requirement that dose-response modeling include a sensitivity 

analysis including all alternative modeling assumptions does not make any 

10 National Academy of Sciences, National Research Council (2009) Science and Decisions: 

Advancing Risk Assessment, Washington DC, National Academy Press, available at 

h ttps :/ /www. nap. ed ul ca ta logill1.Q2/§.(:l<::l.n ce~a nd-d ecis ion s-a dvanci ng -risk ~assessment; 

National Academy of Sciences. National Research Council (1994). Science and Judgment in Risk 

Assessment. Washington DC National Academy Press; 

National Academy of Sciences, National Research Council (1983). Risk Assessment in the 

Federal Government; Managing the Process, Washington DC National Academy Press 

"No. EPA/630/P-03/001 F, available at https://www.epa..:.g_o..Yf..§l!.es/production/files/20'13-

09/documents/cancer ill!Ldelines final 3-25-05.pdf 

12 
70 


33371.052

mention of how those assumptions would be scientifically justified. This lack of 

scientific justification criteria would invite the submission of models that would not 

have biological relevance for inclusion in the sensitivity analysis. This would 

result in a process that would make EPA risk assessment documents unwieldy, 

unmanageable and unreliable. 

• The proposed rule gives obvious preference to specific dose-response models 

(e.g., various cancer threshold models) over current EPA modeling practice. 

This preference is problematic. As an example, EPA cancer modeling generally 

assumes that no exposure threshold exists for carcinogenesis unless data to the 

contrary exist. This assumption includes the recognition of the study design of 

most cancer bioassays, which use a relatively small sample size, resulting in a 

low detection power. This low detection power often makes it difficult or 

impossible to determine the existence of a threshold for carcinogenicity for a 

specific chemical. 

This current EPA cancer modeling practice was developed in documents that 

received public comment and peer-review. That review process included 

consideration of the assumptions noted above. EPA non-cancer modeling 

practice documents also received public comment and peer-review. 

In contrast, the proposed rule's requirement for re-justification of established and 

accepted modeling practices has not undergone any scientific peer review, 

including peer review by EPA's own SAB, lacks scientific consensus, and is not 

scientifically justified in the rule. 

• The proposed rule does not address guidance for evaluating the scientific 

plausibility and usefulness of alternative dose-response models. The proposed 

rule generally does not provide any guidance or direction on how alternatives to 

current EPA dose-response modeling practice would be evaluated for their 

scientific plausibility and usefulness. 

For instance, the preamble to the proposed rule states, "EPA should give 

appropriate consideration to high quality studies that explore ... nonparametric 

models that incorporate fewer assumptions". (83 Fed. Reg at 18770.) 

Unfortunately, nonparametric dose-response models lacking a biological 

background can be manipulated to result in output that does not correspond to 

the biological reality. The proposed rule does not compel such models to be 

consistent with biology and to be evaluated for biological plausibility. 

Additionalfy, the statement in the proposed rule that "EPA should also 

13 
71 


33371.053

incorporate the concept of model uncertainty when needed as a default to 

optimize low dose risk estimation based on major competing models" (83 

Fed. Reg. at 18770) is completely unclear. 

CONCLUSION 

The proposed rule, if adopted, would not strengthen the validity of regulatory 

science that serves as the basis for EPA regulatory action. Instead, it would exclude vital 

science from consideration, delay important regulatory action and interfere with the 

agency's ability to respond to environmental and public health emergencies, all for no 

discern able reason. The proposed rule is unnecessary to ensure that EPA relies on high 

quality science for regulatory action and is instead a dangerous and transparent attempt 

by EPA to limit its consideration of important and valid science that might impel action to 

protect human health and the environment. EPA should abandon the proposed rule. 

14 
72 


33371.054

August 16,2018 

Acting Administrator Andrew Wheeler 

U.S. Environmental Protection Agency 

1200 Pennsylvania A venue, NW 

Washington, D.C. 20460 

Submitted to: http://www.rcgulations.gov 

Subject: Comments on Proposed Rule, "Strengthening Transparency in Regulatory Science,'' 83 

Fed. Reg. 18768 (April30, 2018), Docket ID No. EPA-HQ-OA-2018-0259 

Dear Acting Administrator Wheeler: 

The Project On Government Oversight (POGO) provides the following public comment about 

the Environmental Protection Agency's (EPA) proposed rule, "Strengthening Transparency in 

Regulatory Science,'' published on April 30, 2018. 1 As an independent nonprofit organization 

committed to achieving a more effective, ethical, and accountable federal government, POGO 

has an interest in ensuring that the EPA follows its legal obligations for the use of scientific 

evidence in rulemaking, adheres to all appropriate steps of the rulemaking process, and continues 

to issue and strengthen sound public protections under its statutory obligations. Because this rule 

fails in each of these regards and would cause the EPA to fail in many future rulemakings going 

forward if put into effect, POGO expresses its strong objections to the proposed rule and urges 

the EPA to withdraw it. 

The proposed rule notes that "the best available science must serve as the foundation of EPA's 

regulatory actions" and uses the words "transparency" and "reproducibility" to project lofty 

goals. But, instead of making scientific evidence more available or easier to use, the mle will 

often mean the best available science is ot1'1imits to the Agency. Its real effect will be to 

undermine the way that the EPA is able to rely on and even-handedly assess scientific studies for 

use in the rulemaking process. 

The rule lacks a purpose and scientific basis 

This proposed rule presents no clear explanation or examples of the types of problems it is 

seeking to solve 

This rule lacks a fundamental statement of its purpose or of the problems that it purports to 

address, the central element of any proposed rule. In addition to offering no clear explanation of 

1 83 Fed. Reg. 18768, April 30,2018. https://www.regulations.gov/document?D~EPA-HQ-OA-2018-0259-0001 
73 


33371.055

any problem, the proposal provides no supporting evidence, no studies establishing that the EPA 

has an information problem, nor any citations that the proposed standard has ever been used 

before or that the EPA understands what its impact will be when implemented. This lack of a 

statement of purpose reflects the wholly insufficient development process that produced this rule, 

which, as is described below, originated without input from key stakeholders inside and outside 

of the EPA. 

If the EPA does believe there is a real problem, it should be able to provide some example of a 

scientific study that has been used during rulemaking that does somehow substantively lack 

transparency or fails some standard for reliability. Inclusion of such examples are necessary in a 

proposed rule so that commenters can debate those examples. By failing to include any past or 

present cases that might necessitate its proposed rule, we are left to conclude that there is no 

clear purpose for the EPA's proposal. 

There is no systematic analysis of the use of scientific studies in rulemaking that provides a 

basis for this rule 

Proposing a rule that will fundamentally change what information can be used in future 

rulemakings is a major undertaking and requires a great deal of certainty and evidence. Given the 

complete lack of evidence provided in this case, this proposed rule is premature even if the 

Agency truly believes there is some deficiency in the policies and procedures governing use of 

information in rulemakings. Before proposing any rule, but especially one that is this 

foundational to future rulemaking, the Agency should start by conducting studies to better 

understand the scope of the problem, if there is one, and the best way to improve its use of 

scientific studies. Without such a study, the EPA has provided no evidence to support the claim 

that there is an issue with the "transparency of EPA regulatory science'' or that there is a need for 

the public to be able to "replicate findings," as the rule suggests. 

This type of study should go hand-in-hand with an evaluation of the rule and its supporting 

evidence by the EPA's Science Advisory Board (SAB). In this case, to appropriately assess the 

scientific claims being made, the SAB should be allowed to fully investigate and offer specific 

recommendations on the rule. In fact, the SAB itself has said that the rule "deals with a myriad of 

scientific issues for which the Agency should seek expert advice from the Science Advisory 

Board."2 

In fact, scientific studies are already thoroughly evaluated under the current rulemaking 

process 

As is described below, this rule's implementation will place large portions of scientific research 

off-limits during EPA rulemaking. Instead of arbitrarily excluding broad types of studies from 

2 Memorandum hom Alison Cullen, Chair, SAB Work Group on EPA Planned Actions for SAB Consideration of 

the Underlying Science to Members of the Chartered SAB and SAB Liaisons, regarding Preparations for Chartered 

Science Advisory Board (SAB) Discussions of Proposed Rule: Strengthening Transparency in Regulatory Science 

RIN (2080-AAI4), May 12,2018. 

https:/ /yosemite.epa.gov/sab/sabproduct.nsf/E21 FF A£9568548258525 828C00808BB7 /$Filc/WkGrp memo 2080-

AAI4_finai_05132018.pdf - -

2 
74 


33371.056

being cited in rulemaking, why not continue to give Agency scientists the ability, as they have 

had for decades, to comprehensively assess and compare the scientific evidence presented in a 

study and give weight to each study as a result of careful deliberation? 

During the rulemaking process, EPA officials already decide if studies are unreliable or flawed 

based on the studies' own merits-and sometimes even flawed studies can offer important 

insights that the EPA should benefit from. For each rule, the Agency is already required to fully 

explain its reasoning and the studies relied on, offer dockets of supporting information, and have 

a public comment period. This notice-and-comment process already allows outside stakeholders 

to raise concerns or problems with the science used or offer alternative studies. The Agency has 

to consider and respond to those comments, which commonly occurs in the form of an extensive 

explanation that accompanies the final rule in the Federal Register. 

A letter from the chief editors of six of the major scientific journals explains this process of 

evaluating studies, even when data cannot be made public: 

"The merits of studies relying on data that cannot be made publicly available can still be 

judged. Reviewers can have confidential access to key data and as a core skill, scientists 

are trained in assessing research publications by judging the articulation and logic of the 

research design, the clarity of the description of the methods used for data collection and 

analysis, and appropriate citation of previous results." 3 

The rule fails to explain its two key requirements for the use of studies in 

rulemaking 

The rule fails to properly define the two key requirements that will have a major impact on how 

it is implemented: I) how to anonymize sensitive data for public release and 2) the distinction 

between replicability and reproducibility and how either precisely applies to scientific studies. 

Without knowing the details of how these transparency and replicability provisions, central to the 

rule, will be implemented, commenters can't even begin to assess the wide-ranging outcomes of 

this rule. Even ignoring the fact that this rule provides no statement of purpose, as described 

above, or that it was created with significant procedural shortcomings, as described below, the 

fact alone that it is impossible to provide substantive comment is sufficient reason for this rule to 

be withdrawn. 

The rule provides only a vague description of how to anonymize data 

First, the rule states that data relied on in making regulations must be made publically available. 

but there are a variety of valid reasons researchers don't publish all the underlying datapersonally identifiable information and confidential business information being among the 

biggest concerns. 

1 Jeremy Berg, eta/., "Joint statement on EPA proposed rule and public availability of data," Science, April 30, 

2018. http:!/sciencc.scicncemag.org/content/early/20 18/04/30/scicncc.aauO 116 

3 
75 


33371.057

The scientific community itself acknowledges that not all data can be made public. The letter 

from the six chief editors explains the sharp limits on transparency, stating that "in not every 

case can all data be fully shared. Exceptional circumstances, where data cannot be shared openly 

with all, include data sets featuring personal identifiers."4 

Given the range of studies and information that would be affected by the proposed rule, the 

Agency would need numerous and complicated processes to ensure that data was properly 

anonymized. The EPA's proposed rule claims there are ways to mask data to ensure privacy is 

protected, but fails to provide any details or specifics for how such a process would be 

implemented-this is not a simple issue of redacting a few data fields. But instead of providing 

specific steps for how this process would be handled so that commenters could provide input, the 

rule is all but silent on this issue. 

Some scholars have explored ways to better anonymize data in scientific studies, but those 

efforts are not foolproof. Even when personal identifying information is removed from data, it 

can be possible to identify individuals in the right circumstances from a combination of simple 

data points 5 The most effective way to protect personal privacy, then, is to not publish the 

detailed data underlying these studies at all. In these cases, even though the studies have been 

conducted by reputable researchers at academic institutions, and peer reviewed to ensure 

validity, they would ultimately be unavailable to Agency officials as evidence in rulemakings. 

The rule fails to differentiate meaningfully between reproducibility and replicability 

The second key consideration that the proposed rule fails to address is a concrete definition for 

what it means for information that "includes the information necessary for the public to 

understand, assess, and replicate findings,'' which is the standard the rule attempts to establish 

for information that is considered "publicly available in a manner sufficient for independent 

validation." Besides a vague list containing items that may be included in this type ofpublically 

available and replicable information (''data," "associated protocols." "computer codes and 

models involved in the creation and analysis of such information," ''recorded factual materials,'' 

and "detailed descriptions of how to access and use such information,"), no further description of 

what it means to "replicate findings" is given. 

Confounding matters, while the statement of the rule itself refers to replicability of scientific 

findings, the background information supporting the rule focuses on scientific studies' 

''reproducibility," which has a wholly different meaning in a scientific context. While the 

definitions of these terms continue to be debated by scientists, which further demonstrates the 

difficulty in how the EPA has used them, there is broad consensus: 6 a study is commonly defined 

by scientists as replicable if its findings can be obtained again through conducting a new, 

'Jeremy Berg, eta/., "Joint statement on EPA proposed rule and public availability of data," Science, April30, 

2018. http://science.sciencemag.org!content/early/2018/04/30/science.aauO 116 5 Mark van Rijmenam, "The Re-ldentification Of Anonymous People With Big Data," Datafloq, February 10,2018. 

https://datatloq.com/read/re-identifYing-anonymous-people-with-big-data/228 

''Mark Libennan, "Replicability vs. reproducibility-- or is it the other way around?" Language Log, October 3 I, 

2015. http://languagelog.Idc.upenn.edu/nlll?p~21956 

4 
76 


33371.058

independent study, whereas a study is typically defined as reproducible if reanalysis of data 

collected during that study, using the same or similar methods, produces the same findings. 

The vast disparity in these definitions, and the fact that both terms are mentioned multiple times 

between the proposed rule and its supporting information, leaves us to guess what the intent of 

the rule really is, which means commenters simply can't interpret how this rule will be 

implemented. But, because the rule itself says it must be possible to "replicate" studies' findings, 

we should assume that the rule may intend the strongest possible meaning: that it must genuinely 

be possible to conduct all studies used in rulemaking again, from scratch, and obtain the same 

findings. As we explain below, this then establishes a standard that would preclude an enormous 

quantity of studies form being used in the rulemaking process. 

The rule will undermine the use of scientific evidence in rulemaking 

Scientific studies that could inform rulemaking will be thrown out 

Essentially, the proposed rule would require that the Agency only use studies for which the 

underlying data is fully public or whose findings can be replicated in their entirety. So it's 

reasonable to conclude that, if the rule goes into effect, the EPA will no longer be able to use a 

large portion of the studies that it currently relies on, including important longitudinal human 

health studies, to craft public safeguards. Major health studies often collect large amounts of 

information about the people who agree to participate and there are laws, like the Health 

Insurance Portability and Accountability Act of 1996/ that strictly prohibit sharing a person's 

medical information. 

In the letter from the six major scientific journals, 8 after the editors raise concerns about limiting 

scientific evidence, they also conclude that "excluding relevant studies simply because they do 

not meet rigid transparency standards will adversely affect decision-making processes." 

The Agency also uses many studies, such as those that link living in proximity to an airport to 

toxic blood lead levels in children9 or studies that found a link between fine particulate air 

pollution and premature deaths, 10 that cannot be repeated, because they were based on 

environmental disasters or major exposures to toxic substances. Just because they can 't---{)r 

shouldn't-be repeated, however, doesn't mean we should ignore the vital insights they provide. 

The knowledge we have gained from these tragedies can and should be used to help safeguard 

the public in the future. 

7 https://www.gpo.gov/fdsys/pkg/PLA W-1 04publ191/pdf/PLA W-1 04publ191.pdf 8 Jeremy Berg, era/., "Joint statement on EPA proposed rule and public availability of data," Science, April 30, 

2018. http://scicnce.sciencemag.org/content/early/20 18/04/30/science.aauO 116 9 Marie Lynn Miranda, era/., "A Geospatial Analysis of the Effects of Aviation Gasoline on Childhood Blood Lead 

Levels," Environ lfealrh Perspecr, Vol. 119, Issue I 0, October 201 I, p. 1513-1516. 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3230438/ 

10 Douglas W. Dockery, era! .• "An Association between Air Pollution and Mortality in Six U.S. Cities," N Eng/ J 

Med, Vol. 329, December 9, 1993, p. 1753-1759. Results were then confirmed by an independent reanalysis: Health 

Effects Institute, "Reanalysis of the Harvard Six Cities Study and the American Cancer Society Study of Particulate 

Air Pollution and Mortality" July 2000. https:i/www.hcaltl>effects.org/system/files/HEI-Reanalysis-2000.pdf 

5 
77 


33371.059

Instead, banned from being allowed to make use of the vast wealth of scientific evidence based 

on human subjects, Agency officials will be left with studies that don't have any personal 

privacy concerns, such as industry studies that often rely on animal test subjects. 11 

The rule will put the EPA in the position of setting standards for studies, significantly 

reducing the number of studies the EPA can rely on 

The rule's constraints on the use of scientific studies mean that even the use of studies that don't 

end up being haphazardly tossed out by this rule will be hindered substantially. 

The rule also puts the Agency in a position in which it's forced to serve as an independent 

reviewer of all scientific data underlying studies it uses, effectively having to peer-review these 

studies, which will severely hamstring Agency scientists, who already have limited resources. 

When the EPA was sued over air quality standards for particulate matter and ozone during the 

George W. Bush administration, the U.S. Court of Appeals for the District of Columbia Circuit 

said a requirement to make public the underlying data for the key studies used in the rulemaking 

process would be "impractical and unnecessary." 12 

The three judge panel concluded that, "if EPA and other governmental agencies could not rely on 

published studies without conducting an independent analysis of the enormous volume of raw 

data underlying them, then much plainly relevant scientific information would become 

unavailable to EPA for use in setting standards to protect public health and the environment ... " 

The Congressional Budget Office (CBO), in response to the HONEST Act of2017, 13 a piece of 

legislation with very similar provisions to the proposed rule, has said that this type of policy, 

without a major funding commitment, would significantly reduce the number of studies that the 

EPA is able to rely on when proposing rules. 14 

If the EPA wants to address the accessibility of scientific studies and data, an important issue to 

scientists as well as members of the public, it should acknowledge that those efforts, which 

might include building a new public-facing platform or carefully considering certain types of 

standards, will amount to a years-long process and will require an enormous investment of 

Agency time and funding. That type of proposal shouldn't be made in a brief proposed rule, 

however, and should only be made, as described above, if extensive studies demonstrate that 

there is a real need for an update to how scientific studies are used in Agency rulemaking. 

11 Warren Cornwall, "New rule could force EPA to ignore major human health studies," Science, April 25, 2018. 

http:llwww.sciencemag.org/news/20 18104/new-rule-could-force-epa-ignore-major-human-health-studies 12 American Trucking Associations, Inc., et al., Petitioners, v. Environmental Protection Agency, 283 F.3d 355 (D.C. 

Cir. 2002). https:/llaw.justia.comlcases/federal/appellate-courts/F312831355/4844911 

" *https:llwww.congress.goV!billlll5th-congress/house-bill/1430 

14 EPA analysis of Honest Act to Cl30, 2017. https://www.scribd.comldocument/344731162/EPA-analysis-ofHonest-Act-to-CI30 

6 
78 


33371.060

The process for creating this rule was severely flawed and will result in 

procedural issues for future rules 

There is no statutory authority for this rule 

The EPA is proposing this rule without any clear statutory authority from Congress. Agencies 

are not permitted to create new laws or requirements unless duly authorized by Congress. While 

an agency has authority in its given issue area, which, in the case of the EPA, is protecting the 

environment, that authority is not absolute. 

The EPA claims that its authority for this rule stems from "provisions providing general 

authority to promulgate regulations necessary to carry out the Agency's functions" under a 

number of environmental laws. This is a grave misinterpretation of the Agency's authority under 

these laws, as none of these laws require or mention transparency requirements for scientific 

studies. Agencies do offer new regulations or update existing ones under the authority of longstanding statutes, but these are done because of changes in technology, science, or law that then 

require new rules to properly enforce the original intent of the statute. But this proposal to 

regulate what counts as usable science during rulemaking is far removed from the intent 

Congress had in passing laws about keeping our air and water clean and protecting the public 

from hazardous chemicals. 

In fact, this proposal would directly contradict requirements in several of the laws cited by the 

Agency that instruct the EPA to consider available science in rulemakings. For instance, the Safe 

Drinking Water Act directs the EPA to base its determination about whether to regulate any 

particular contaminant "on the best available public health information." 15 Additionally, the 

Toxic Substances Control Act requires the EPA to take regulatory action "consistent with the 

best available science." 16 

The rule violates the Administrative Procedure Act 17 

The Agency also seems to claim it derives some authority from "requirements in the 

Administrative Procedure Act (APA) to ensure public participation in the rulemaking process." 

However, that is again an overly broad interpretation. Federal agencies have overseen public 

participation in rulemakings for years. The proposed rule would not improve the key public 

participation components such as rulemaking disclosures or the notice and comment process. 

If anything, the rule is in violation of the AP A, which makes it clear that an agency can not 

engage in arbitrary and capricious actions or decisions in rulemakings. The Agency must have 

clear and strong justification for actions taken in a rulemaking. Given the lack of supporting 

evidence or statutory requirement for this policy, the EPA will be hard pressed to prove that this 

untested standard for scientific transparency is not arbitrary. 

15 *42 U.S.C. § 300g-l(b)(l)(B)(ii)(ll) 16 *!5 U .S.C. § 2625(h) 17 *5 U.S.C. §§ 553. 706. 

7 
79 


33371.061

In fact, if the rule were put into effect, it could undermine future rulemakings by the EPA. Many 

of the proposed rules using these standards could be challenged in court and deemed "arbitrary 

and capricious" because they exclude relevant data and studies for failing to meet poorly 

established data transparency requirements. Separately, if a commenter referred substantively to 

a study that the EPA was barred from using, the Agency's failure to respond to the comment 

could also cause the rule to be deemed ''arbitrary and capricious." 

The proposed rule gives the Administrator alone discretion to exempt future rulemakings from 

this rule "on a case-by-case basis if he or she determines that compliance is impracticable," 

either because scientific data underlying the rule cannot be made appropriately publicly available 

or because a review of the science cannot be conducted in accordance with cited guidance from 

the Office of Management and Budget. Because the rule does not provide any mechanism for 

evaluating if studies should be exempted from the rule's requirements, however, there is no 

reason to conclude that the Administrator will make case-by-case exemptions appropriately and 

there is no way to prevent exemptions from be granted arbitrarily. 

The rule should be withdrawn 

In conclusion, POGO finds the EPA to be without sufficient authority to propose this rule and 

the proposed rule itself to be incomplete, ill-considered, and contrary to the Agency's mission to 

protect the public and environment. Therefore, we again urge the EPA to withdraw this rule. 

We appreciate your consideration and attention to this matter. If you have questions or need 

additional information, please contact us at 202-347-1122 or smoulton@pogo.org. 

Sincerely, 

Sean Moulton 

Senior Policy Analyst 

Andrew Bergman 

Special Environmental Advisor 

8 
80 


33371.062

August 16, 20 1 8 

VIA ELECTRONIC SUBMISSION 

The Honorable Andrew Wheeler 

Acting Administrator 

U.S. Environmental Protection Agency 

1200 Pennsylvania Ave., N.W. 

Washington, DC 20460 

Attn: EPA-HQ-OA-2018~259 

Re: Comment of the Environmental Defense Fund on the Environmental Protection 

Agency's Proposed Rule: Strengthening Transparency in Regulatory Science, 83 Fed. Reg. 

18768 (Apr. 30, 2018) ("Proposal") 

Environmental Defense Fund ("EDF") submits the following comments on EPA's April 

30,2018 proposed rule, ·•strengthening Transparency in Regulatory Science" (the "Proposal"). 1 

Representing over two million members and supporters, EDF applies science, economics, and 

the law to solve our most urgent public health and environmental problems. EDF regularly 

engages in policy advocacy, regulatory proceedings, and litigation to secure and defend 

protections for human health and the environment under the Clean Air Act ("CAA "),Toxic 

Substances Control Act ("TSCA "), and other statutes administered by EPA-protections that 

save lives, improve well-being, and provide a more vibrant economy for all Americans, 

including our members. EDF and our members therefore have a profound stake in ensuring that 

EPA actions are anchored in the best available science, and are not distorted by policies and 

practices that seek to unjustifiably limit EPA ·s use of science tor the purpose of weakening 

health and environmental protections. 

For the reasons explained below, the Proposal would violate EPA's substantive and 

procedural obligations, is arbitrary and capricious, and must be withdrawn. Indeed, the Proposal 

is the classic wolf in sheep's clothing. Cloaked in vague platitudes about scientific quality and 

promoting "transparency," the Proposal would establish a sweeping new regulatory requirement 

prohibiting EPA ti·om considering public health studies for which underlying data cannot be 

made "publicly available in a manner sufficient tor independent validation."2 This requirement 

would bar EPA from considering many vital public health studies that are based on confidential 

patient information that cannot be legally or ethically disclosed, and have been rigorously vetted 

using time-tested approaches that are widely accepted in the scientific community. Nowhere 

does the Proposal document what deficiencies in existing EPA regulatory science it is trying to 

solve, much less why such draconian restrictions on the use of science would improve the quality 

of EPA decision-making. 

This wolfs true nature, however, cannot be covered up: the Proposal is in fact directed 

at excluding the best available science demonstrating significant health and welfare effects from 

1 Strengthening Transparency in Regulatory Science, 83 Fed. Reg. 18,768 (Apr. 30. 20 18). 2 !d. at 18,773 (proposed 40 C.P.R. § 30.5). 
81 


33371.063

agency decision-making in order to thwart the agency's ability to protect the public health and 

welfare. As our comments document, the Administration hastily concocted this Proposal as a 

way of unilaterally implementing failed legislative proposals backed by prominent opponents of 

accepted climate change science and patterned on proposals put forward by the tobacco industry 

in the 1990s. According to records obtained from EPA through the Freedom of Information Act 

when this Administration's own political staff discovered that earlier versions of the Proposal 

might also restrict industry-funded science supporting the registration of pesticides and other 

chemicals, it decided to ''thread this one real tight!" to ensure that only those studies supporting 

public health regulations would be subject to this new "transparency" rule. 3 

Ultimately, this Proposal does not "strengthen science." EPA's Science Advisory Board 

("SAB'') and the scientific community were not even consulted in its development, and a host of 

scientific authorities-including members of the SAB, editors ofthe nation's leading scientific 

journals, the National Academies, and numerous scientific and medical organizations-have 

raised fundamental concerns about the Proposal. Rather than strengthen science, the Proposal 

grants the Administrator vague and manipulable authority to censor science that by any scientific 

definition is the best simply because it connicts with this Administration's political goals. We 

urge EPA to abandon this deeply destructive and misguided Proposal. 

'See discussion in(i·u Section VII. 

2 

Respectfully submitted, 

Tomas Carbonell 

Ben Levitan 

Jennifer McPartland 

Ryan O'Connell 

Martha Roberts 

Ananya Roy 

Surbhi Sarang 

Robert Stockman 

Environmenral Defense Fund 

Keri Powell 

Alexandra Teitz 

Steve Silverman 

Susannah Weaver 

Consultants for Environmental 

Defense Fund 
82 


33371.064

TABLE OF CONTENTS 

OVERVIEW ................................................................................................................................... 7 

Terminology .................................................................................................................................... 9 

I. EPA's Proposed Rule Violates Numerous Substantive Statutory Requirements .................. 13 

A. EPA Does Not Have Authority to Issue the Proposed Rule .......................................... 13 

B. The Proposed Rule Violates EPA's Statutory Authorities ............................................. 14 

I. EPA's statutory authorities generally require the agency to consider all available data 

when undertaking significant rulemakings ........................................................................... 15 

2. The proposal violates these statutory commands by requiring EPA to ignore science 

when undertaking significant rulemakings ........................................................................... 16 

3. By prohibiting EPA from considering all valid and relevant studies when undertaking 

significant rulemakings, the proposed rule would prevent EPA from complying with an 

array of statutory provisions governing EPA's consideration of available science .............. 22 

4. EPA's proposed exemption provision docs not remedy the unlawfulness of 

prohibiting EPA from considering valid and relevant studies due to the public unavailability 

of underlying data and methods ............................................................................................ 32 

C. EPA's Proposed Rule Would Violate the Information Quality Act... ............................ 34 

Tl. EPA's Proposed Rule is Unreasonable and Arbitrary and Capricious .................................. 35 

A. EPA Failed to Consider the Legitimate Reasons That Underlying Data May Not be 

Made Publicly Available, or to Propose Solutions to Remedy These Actual Limitations ....... 36 

1. There are multiple reasons why underlying data are not publicly available for all 

studies ................................................................................................................................... 36 

7 The Proposal fails to propose any actual solutions to remedy the legitimate reasons 

for why data may not be made publicly available ................................................................ 40 

B. The Proposal Will Not Advance the Supposed Cause of ··Transparency" Upon Which it 

is Based ..................................................................................................................................... 48 

I. Where there are lower hurdles to making data publicly available, this is already 

commonly occurring, with support ii·om various initiatives ................................................. 48 

2. EPA's proposed approach does not require researchers to make underlying data 

publicly available .................................................................................................................. 49 

C. The Proposal does not Acknowledge, Much Less Examine, its Likely Actual EffectReducing the Quality and Quantity of Studies upon which Regulatory Decisions are Based. 51 

I. EPA fails to recognize that forcing the disclosure of all data and models would have 

harmful effects on the quality and quantity of scientific research used by EPA .................. 51 

3 
83 


33371.065

2. Because EPA will be barred from using many valid scientific studies with nonpublic 

data, the net effect of this proposal will be to harm, not strengthen. EPA's use of science in 

the regulatory process ........................................................................................................... 52 

D. EPA's Policy Rationales for its Proposal are Arbitrary and Capricious ........................ 64 

I. EPA arbitrarily fails to provide a reasoned explanation for why the proposed rule is 

needed ................................................................................................................................... 64 

2. EPA arbitrarily fails to offer a reasoned explanation for its departure from existing 

policies that broadly require the agency to consider all available scientific information when 

undertaking rulemakings ....................................................................................................... 67 

3. EPA's Proposal arbitrarily fails to consider and deviates from best practices in 

scientific review, which support using a broad array of information. informed by a "weight 

of the evidence" approach, rather than arbitrarily excluding certain studies up front. ......... 68 

4. EPA irrationally conflates scientific "validity" and "transparency" with data 

availability, incorrectly assuming that eliminating the use of studies without publicly 

available data will improve scientific validity and transparency .......................................... 70 

5. EPA arbitrarily attempts to bolster one element of scientific transparency, while 

ignoring significant other transparency-related concerns ..................................................... 75 

6. EPA's justification of the proposal is incoherent and lacks almost any evidentiary 

support ................................................................................................................................... 75 

7. EPA has failed to explain why it has singled out dose response studies to be excluded 

iftheir underlying data and models are not publicly available, but has not similarly targeted 

any other types of studies commonly used by EPA .............................................................. 79 

8. EPA arbitrarily failed to consider the implications of this proposal on interagency 

coordination .......................................................................................................................... 80 

9. EPA's proposal irrationally excludes proceedings that tend to benefit industry 

interests, even though these proceedings are far less transparent than the rulemakings EPA 

bas targeted ........................................................................................................................... 81 

E. EPA's Proposal is Arbitrary Because it is Inconsistent With Long-Standing EPA and 

Federal Government Policies and Ongoing Efforts to Strengthen Science Quality in a 

Measured and Balanced Way through EPA's Existing Science Policies ................................. 85 

I. Instead of providing a reasoned explanation for its change in policy, EPA wrongfully 

claims the Proposal is consistent with existing EPA, federal government, and third-party 

practices and policies ............................................................................................................ 86 

2. EPA's Proposal fails to consider important implementation problems that existing 

EPA and federal government policies place at the forefront. ............................................... 91 

TIL The Proposed Rule's Peer Review Provisions Raise Numerous Concerns ........................... 94 

A. EPA Has Failed to Consider the Costs of Making OMB Peer Review Requirements 

Judicially Enforceable ............................................................................................................... 94 

B. EPA Must Clarify that Studies that Have Already Been Adequately Peer-Reviewed by 

Third Parties Need Not be Re-Reviewed by EPA .................................................................... 95 

4 
84 


33371.066

C. EPA Must Clarify the Intent of the Exemption Provision with Respect to Peer Review 

Requirements and Confirm that the OMB Peer Review Bulletin's Waiver Provision Would 

Remain in Effect for EPA ... ,., ........... ,,,,., .. , .... ,.,.,.,.,,,.,., ............ , ............................. 95 

D. EPA Must Clarify How the Proposed Rule Would Impact EPA's Existing Peer Review 

Handbook .................................................................................................................................. 96 

IV. The Proposal Would Impose Arbitrary and Inappropriate Methods for Assessing Health 

Risks ............................................................................................................................................. 97 

A. EPA's Proposal Seeks to Undermine Key Scientific and Public Health Tenets Relating 

to Dose-Response and the Use of Defaults ............................................................................... 97 

1. The proposal arbitrarily dismisses linear (i.e., non-threshold) dose-response 

relationships .......................................................................................................................... 98 

2. The proposal improperly dismisses defaults ......................................................... ,. 100 

3. The Proposal arbitrarily promotes studies that include a variety of dose-response 

models ................................................................................................................................. 101 

4. The proposed rule provides no justification for codifying scientific approaches into 

regulation ............................................................................................................................ 101 

V. EPA Fails to Adequately Consider Costs and Benefits of the Proposal. ............................. 101 

VI. EPA Fails to Comply with the Paperwork Reduction Act. ..................................... , .......... 108 

Vll. The Circumstances Surrounding the Proposed Rule Indicate that it Was Based on a Desire to 

Suppress Vital Public Health Science for the Benefit of Certain Regulated Industries ............. 110 

A. The Proposed Rule is an Attempt by EPA to Implement an Unenacted Congressional 

Bill, The HONEST Act... ........................................................................................................ Ill 

1. Available information on the development of the proposal illustrate its industry 

origins ................................................................................................................................. 115 

13. EPA's Proposed Rule Mirrors Policies That the Tobacco Industry Advocated for in the 

1990's to Suppress Unfavorable Science ................................................................................ 117 

C. EPA, Under the Trump Administration, Has a History Of Suppressing Science and 

Transparency, Undermining the Purported Justifications for the Proposal., .... , ............ , ... , 118 

VIII. The Proposal Violates Procedural Requirements of the APA, CAA. and Other Statutes 

and Executive Orders ... , .................................. , ........... , .................... ,,., ................................. 121 

A. The Proposed Rule is a Binding, Legislative Rule and Subject to the Requirements of 

the APA ..................................................................... , .................... ,,., .... ,, ... , .................... 122 

B. The Proposal is Subject to the Procedural Requirements of the Clean Air Act.. ......... 123 

C. EPA !las Failed to Provide a Properly Developed Docket and Record as Required by 

the APA and CAA and Has Thereby Violated the Notice Requirements ofthesc Statutes ... 124 

D. The Proposal is too Vague for Meaningful Comment. .. ,.,,,,, ... ,, .. , .... , .. , ...... , .. , 128 

E. EPA Must Comply With Other Requirements of the Clean Air Act ............ ,,,,, ..... 131 

F. EPA Failed to Submit the Proposal to the SAB or to Consult with the Scientific and 

Technical Community .... , .. , .................................. , ........ , ...... , .. , .............................. , ....... , 132 

5 
85 


33371.067

G. EPA's Proposal Fails to Meet the Procedural Requirements of FIFRA ...................... 133 

H. EPA's Proposal Fails to Meet the Procedural Requirements of the Safe Drinking Water 

Act, 42 U.S.C. § 300fEt Seq .................................................................................................. 134 

I. EPA Unlawfully Failed to Consult with Other Agencies as Required by TSCA ........ 134 

J. EPA Has Failed to Consult with the Science Advisory Committee on Chemicals ..... 135 

K. EPA Has Failed to Provide Documents in Response to EDF's FOIA Requests ......... 135 

L The OIRA Review Process for the Proposal Was Too Rushed to be Meaningful and 

EPA Has Not Sufficiently Coordinated with Other Federal Agencies ................................... 135 

Appendix A. Analysis of Sources Cited to in the Proposal ........................................................ 13 8 

Appendix B. Provisions of Federal Environmental Statutes Requiring EPA to Consult With 

Other Federal Agencies in Implementing Key Programs ........................................................... 183 

6 
86 


33371.068

OVERVIEW 

The Proposal acknowledges that ··[t]he best available science must serve as the 

foundation of EPA's regulatory actions."'4 But it then requires EPA to systematically ignore the 

best available science when it regulates to protect human health and welfare. This is counter to 

EPA's statutory mandates to use "best available science," and the proposal is a transparent 

attempt not to strengthen science, but rather to censor science that is inconvenient to the current 

Administration's political goals. 

Since EPA was established nearly haifa century ago. the Agency and its leadershipunder Administrations of both parties-have recognized the central role that rigorous science 

plays in fultilling the Agency's mission of protecting human health and the cnvironment 5 EPA's 

obligation to consider the best available science is not only a policy commitment that flows fi·om 

the Agency's mission; it is a legal obligation enshrined in many of the fundamental public health 

and environmental statutes that EPA is charged with administering. The agency has established 

an array of mechanisms over the last five decades-including "rigorous review" by its scientific 

advisory boards "that goes beyond the typical journal peer review procedures"6

-to ensure that 

the Agency's decisions arc grounded in the best available science. 

The Administrator's proposal does not build on this strong foundation; to the contrary, it 

crumbles it. The purpose and effect of the proposal would be to degrade the quality of science in 

EPA ·s decision making. While the proposal suggests that its aim is to improve transparency by 

increasing public availability of data, in actuality it proposes none of the steps that a proposal 

seriously aimed at that goal would propose, such as increasing funding for EPA grantees to 

undertake this effort, or proposing solutions to real concerns about patient contidentiality. 

Instead, the heart of the proposal is a bar on considering science simply because the underlying 

data is not publicly available, regardless of whether the science has been peer reviewed, 

reproduced. or contains other hallmarks of scientific quality. Indeed. the agency's recent 

communication to the Congressional Budget Office that a similar Congressional proposal could 

be implemented at "no cost" proves the point: EPA's aim here is not to make more data available 

(which costs money), but to rely on Jess science in decisionmaking. 

The agency's arbitrary, single-minded focus on considering studies for which certain data 

and models arc publicly available (but only the dose-response studies relevant to health 

4 83 Fed. Reg. at 18.769. 5 Brady Dennis, Outgoing EPA chief Science is _'fundamental to absolure!y ere1ything we do', Washington Post 

(Dec. 21. 2016) (quoting Iarmer EPA Administrator Gina McCarthy as saying, "Science is everything. Almost ever) 

action we take is bounded by wbat the science tells us. It's based on a factual record of where the world is today and 

\vhat is our obligation under our mission. Science needs to be protected. Any effort to undermine that science in a 

\vay that v•muld give undue influence to ti:Jlks that aren't scientists is a really big problem,"), 

https:/ /v.,ww. was hi ngtonpost.com/news/energy -en vironmcnt/wp/20 1 6/12/21 /outgoing -epa-chief-sciencc-i scverything-it-is-tundamental-to-ab~olutely-evcrvthing-we-dol?utm term= .6fl e454 72169: Christine Todd Whitman. 

,\'o room for science in Trump Administration, CNN (May 15. 2017). bttps://v.ww.cnn.com/2017/05/15/opinions/noscicnce-in-trump-administration-whitman/indcx.html (describing AJministrator Pruitt's actions as a "trend awa; 

li·om science as the backbone of the EPA and other key lt!derul agencies''). 6 Memorandum by Alison Cullen. Chair. SAB Work Group on EPA Planned Actions for SAB Consideration of the 

Underlying Science 4 {May 12. 20 IS) (observing that the Prorosal ··rails to mention that EPA has mechanisms tOr 

vetting science through several expert pands." including the SAB and others). 

7 
87 


33371.069

protective regulation, not the ones supporting registration of chemicals) stands in stark contrast 

to the way the scientific community validates research findings. The scientific community, and 

scientific journals look to a range of attributes when assessing the quality of a scientific study, 

including whether the study has been peer reviewed, whether the scientists used rigorous 

scientific methods, and whether the study's results have been reproduced or replicated. While 

scientific journals and other institutions have encouraged making data and models publicly 

available, there is widespread recognition in the scientific community that doing so is often 

legitimately constrained due to legal and ethical protections on the confidentiality and privacy of 

data, or because the data is unavailable. Moreover, no scientist or scientific organization supports 

the Proposal's approach of excluding research for which the underlying data cannot be disclosed. 

Indeed. none ofthe materials EPA cites support such an extreme approach. To the contrary, the 

scientific community recognizes that the quality of a study is not determined by whether the 

underlying data is publicly available and has long utilized a variety of tools for ensuring the 

integrity and rigor of research findings. 7 

For all these reasons, numerous representatives of the scientific community-including 

editors of the very scientific journals whose policies EPA cites to in the Proposal, the American 

Association for the Advancement of Science, members of the SAB, and other scientists cited to 

by EPA-have already voiced serious concerns about the Proposal. 8 As these experts have 

recognized, it is not consistent with good scientific practice, and certainly not consistent with the 

Agency's responsibility to utilize ''best available science;· to deem certain scientific studies 

unworthy of consideration simply because these studies cannot meet an arbitrary public 

availability requirement. 9 Far from promoting the integrity of Agency decisions, the Proposal's 

simplistic approach would impoverish the Agency's decision-making by excluding the 

consideration of scientific studies that, standing alone or in combination with other studies. have 

significant bearing on vital public health and environmental protections. This. in turn, would 

result in regulations that are not based on "best available science" and that will provide 

inadequate protection for the very public health and welfare that EPA has been charged by 

Congress to safeguard. 

7 .)'ee id at 4 ("The propos!.!d rule fails to mention that there are various ways to assess the validity of prior 

~pidemiologic studies without public access to data and analytic methods."). 

x E.g.. Anne Q. Hoy. ,)'cientffic Leaders ,)'peak Out on tPA ·s Proposed ·'Transparency Rule.· 

https://v.,rww.aaas.org/news/scicntifi~:~leaders-speak-out-epa-s-proposed-transparencv-rule: Jeremy Berget a! .. Joint 

Statement on EPA Proposed Rule and Public Availability of Data, Science (Apr. 30, 2018). 

http://science.scicncemag.org/contcnt/carh/20 l8/04/301science.aau0116; Letter to Acting Administrator Wheeler 

ii·om \1arcia McNutt, President of the National Academy of Sciences, C. D. Mote. Jr .. President of the National 

Acadcm: of Engineering, and Victor J. Dzau. President of the National Academy of Medicine (July 16. 2018) 

(Warning that ·'overly stringent requirements tOr transparency may cause valid evidence to be discarded and thereb)" 

pose a threat to the credibility of regulatory science)·· and stating that ·'The National Academies have developed a 

long-standing body of work that demonstrates scientific literature can be evaluated in a transpanmt and objective 

manner without complete disclosure of the underlying data.··). 9 See John loannidis. All science should inform policy and regulation. 15 PLOS 5 (May 3. 2018) ("Past collected 

and analyzed information can and should still be used for dccisionwmaking. taking into account any relevant 

imperfections. While fully transparent and reproducible int(wmation should certainly be valued more highly. studies 

with weaknesses can still offer insights."). 

8 
88 


33371.070

That, of course, appears to be the current Administration's goal. A close examination of 

the history of this Proposal confirms that its purpose is not to strengthen science at EPA, but to 

undermine public health and environmental protections by arbitrarily blinding the agency to vital 

research. Indeed, the Proposal resembles proposals advanced by the tobacco industry for the 

specific purpose of suppressing public health science warning about the dangers of tobacco 

smoke. 10 The Proposal also resembles failed legislation in Congress that was similarly advanced 

by industry interests seeking to undermine public health and environmental protections, and 

criticized by scientific experts. 11 EPA documents released in response to Freedom oflnformation 

Act (FOIA) requests relating to the Proposal show that Trump Administration appointees 

deliberately tailored the scope of the Proposal in order to promote industry interests. 

EPA's purpose and mission is to protect human health and welfare, not to promote the 

agendas of the worst polluters and their allies in order to weaken health and welfare protections. 

EPA should withdraw this misguided and harmful proposal. 

Terminology 

At the outset, it is useful to review relevant terminology, which the Proposal appears to 

confuse and conflate. A recent National Academy ofScicncL•s workshop produced the lollmving 

definitions of'·reanalysis." ·'replication." and ·'reproduction," each of which has a diftcrcnt 

scientific meaning and dift~rent applications and implications." Let's consider each of these 

de fin it ions separately. 

11 reana~rsis is when you conduct afi;rther analysis olduta. A person doing a reonalvsi.\· 

of data may use the .\a me programs and sratisticalwethodoio!{ies thai were originally 

used to mwlr::e the data or lila)' use alternative merhodologies. hurrhe point is to wwly=c 

e.wcrlv the some dma to see i/rhe same result emergesfi·om the analvsis. 

A reanalysis docs validate or invalidate a study findings. If all credible methods of 

reanalysis yield effectively the same results as the original analysis. this docs strengthen the 

original findings. The usc of differing statistical models should be assessed with care and 

demonstrate that the assumptions supporting a new method of analysis is significantly more 

credible than the: original unalysis. It is easy to develop methods of analysis that can demonstrate 

10 Emily Atkin. The EPA is A cling Like Big Tobacco. The New Republic (Apr. 26. 20!8). 

https://ncvvrepuh!ic.com/artic!e/148126/epa~acting-like-big-tobacco {describing the role of Steve Miltoy. a leading 

public proponent of the Proposal who has taken credit for its existence. in crafting similar policy proposals on behalf 

of the tobacco industry-funded Advancement ofSounJ Science Coalition). 11 Letter by U.S. Science. Engineering. and Academic Institutions to Kevin McCarthy, House Majority Whip (Mar. 

16. 2015) (opposing "Secret Science Rctorm Act. H.R. 1030"). https:llsciencepolicy.agu.orgltiles/2013107/AAASSecret-Science-letter-McCarthv-2015.pdf; Letter hy Barry Nussbaum. American Statistical Association to Sen. 

Mike Rounds and Sen. Kamala Harris (May 25. 2017) (opposing HONEST Act, H.R. 1430). 

https:tlwww.amstat.orglasa/tileslpdtsiPOL-HONEST ActLetter.pdf 1

:: National Academies of Sciences. Engineering. and Medicine. Principles and obstacles for sharing datafrom 

em•ironmental hea!Jh research: ¥Yorks hop summary. The National Academies Press (20 16). 

https:/h.nvw.nap.edu/catalog/21703/principles·and-obstaclcs-t<w-sharing-data-fi·om-environmental-health-research. 

9 
89 


33371.071

a dilkrcnt finding, but arc created solely tor that purpose and these should not be given greater 

weight in evaluating a particular study. 

Replicatiou 11/cmls that you acwa!ly repeal a scientific experimenl or a tria/to oblain a 

consislent resull. lhc second experimc111 uses exactlv the same protocols and statistical 

programs but H'ilh dif/i!re11l dawfi·om a different population13 The goal1:1· to see if the 

same results hold wilh da!a/i'0/1111 different population 

Replication predominantly applies to laboratory studies and randomized control trials 

since you arc able to colllrol almost all ofthc experimental details making replication possible, 

Replication docs not enlwncc transparency. In environmental epidemiology, randomized control 

trials arc not feasible or ethicaL and replication of observational studies is virtually impossible 

since it is not possible to create the same conditions as seen in the original study. Even in 

laboratory experiments, replication can be ditlicult due to uncontrolled factors like genetic drift 

in cell lines and animal strains. Finally. if you do have replicate studies and one has a positive 

linding and another has a negative finding. there wotlid have to he additional criteria used to 

determine which study was correct: thus a failure to replicate should not immediately lead to the 

conclusion that there is no effect Rather than replicating a study. it is far better to develop a 

better study that replicates the results while providing greater insight into the basis underlying 

any toxicity. 

And rhen.jinally, when you reproduce a scienli/ic experimenr, you arc producing 

something that is t'erv similar ro that research. lwr if is in a dif/i're/11 medium or contcxl. 

Fur example. "researcher trho is reproducing an experiment addresses the same 

research question but from 11 different angle than/he original researcha did. 

Here, reproduction refers to a body of evidence addressing the same hypothesis. but using 

different populations, methods. etc. Reproduction does not enhance transparency. The majorit) 

of research on the health effects of environmental hazards tall into this category. I !ere. a series of 

studies that address the same hypothesis and give the snme basic result docs indeed strengthen 

findings of toxicity. 

None oftht:sc concepts discusses the scientific quality of the study: this is critical. The 

ability to replicate a study 1vith very poor scientific quality docs not strengthen the scientific 

belief that any toxicity is present. Similarly. studies that attempt to reproduce the same findings 

must have their quality clearly established befi.Jre comparisons can be made across the multiple 

studies. 

An example of how some of these different tcdmiques work in practice is the scientific 

evidence on air pollution and premature death which include the Harvard Six Cities Study and 

the American Cancer Society Cancer Prevention Study II (ACS CPS II). The extent to which 

these studies have been reanalyzed and reproduced is extraordinary and hy no means necessary. 

But they provide a good case study of how these techniques work in practice. 

13 •·oitTerent population" in this context means a different ,~let of the same test subjects (e.g., same animnl species 

and strain. same cell lines). 

10 
90 


33371.072

The originalllarvard Six Cities and IICS CPS II studies on mortality were published in 

1993 and 1995 respectively. 

The llarvard Six Cities study assessed the long-term effects of fine particle pollution 

(PM2.5) over 12 to 14 years ( 1974-!989) on premature mortality among 8.111 adult 

participant> who lived in 6 ditTerent cities: Watertown, MA: Harriman, TN: St. Louis, 

MO: Steubenville. OH: Portage. WI: and Topeka. KS. After accounting for cigarette 

smoking, level of education. body mass index. and nccupational exposure to dusts. gases. 

and fumes, the authors of this study found that for members of the same age and sex 

group there was a 26'Yo higher risk of premature mortality between the study participants 

living in the city with the highest levels of particles (Steubenville) and the city with the 

lowest levels (Portage). 11 

The investigators of the Harvard Six Cities study. along with others, reproduced their 

finding in a separate assessment of the association between tine panicle levels and 

mo1iality among 295,223 adults who lived in 50 metropolitan areas across the United 

States. over a period of7 years ( 1979-1983) in the ACS CPS II study. litter accoullting 

for smoking. education. body mass index. alcohol consumption. and sclt~reported 

occupational expPsure to a number of substances. the scientists found that for participants 

of the same age. race and sex there was a 17% increased risk of mortality with every 25.4 

microgram per meter cube change in f';'vl2.:'i. 1

' 

The llarvard Six Cities Study and the /\CSCPSII were reanalyzed by the Health EtTccts 

Institute, a nonprofit indcrendent research corporation fi.mded b) FPA and the motor vehicle 

industry, under a data sharing agreement. A research team evaluated the consistency and 

accuracy of the data and then undertook a series of comprehensive analyses to test the validity of 

the findings first using the sam.: statistical analyses and then testing the robustness of the original 

findings and interrretations to alternative analytic approaches. The results of the reanalysis were 

resoundingly similar to the original studies. For the Harvard Six cities study the reanalysis found 

a 28% increased risk of mm1ality per 18.6 microgram per meter cube of PM2.5 in comparison to 

26% flmnd in the original study. For the ACS CPS II study the showed that for every 25.4 

microgram per meter cube change in PM2.5 there was an associated 18% increased risk of 

mortality (results ofthc independent reanalysis) vs 17°/o reported by the original study. 1'' 

14 Dockery, D.W .. Pope. C.A .. Xu. X .. Spengler. J.D., Ware. J.fl .. Fay. M.F .. Ferris Jr. B.G. and Speizcr. F.E .. An 

Association Between Air Po/JU!ion and Xfarlafity in Six US Cities. 329(24) New England Journal of Medicine 1753-

1759 ( !993 ). 

"Pope. C.A .. Thun. M..l., Namboodiri. M.M .. Dockery, D.W., Evans. J.S .. Speizer. F.E. and Heath. C.W .. 

Particulate Air Poilu/ion as a Predictor of Morlality in a f'rospeclive SIUdv r>f US Adults. 151(3) American Journal 

of Respiratory and Critical Care Medicine 669-674 ( 1995). 1

<' Krewski. Daniel. ct aL. Reana(vsis of the Harvard Six Cities ,)'tudy and the American Cancer ._)'ociety Study of 

particulate air pollution and mortality. t{)otnote on 249 Health Effects Institute (2000), See also Letter to /\ndrl'\\ 

Whl·elcr !h)ml-larYard! lnhcr:-it) (Docket ID No. EPA-HQ-0/\-201R-0259) {rcanaly~i:-; and "rt:lcasing r'-lw data 

will not impnwc the qualiL) or the rl.'su!ting rcpnrt/stud)/ana!ysis. anJ therl'l{lTL' \\ill do nothing to renJer lln) 

indi\ idua! stud; ·hctt~o.•r."'). 

II 
91 


33371.073

A large body of literature also shows that this association of tine particle pollution and 

mortality has been reproduced in different populations across the globe, 17 over different periods 

of time. contexts and using different methods. Most recently. a study of 61 million elderly people 

enrolled in Medicare across the entire United States t(JIIowcd over 13 years f(lllnd a strong 

association between particle pollution and increased risk of mortality. at even the current levels 

of air pollution and below the current air quality standards f\Jr PM2.5. ~ It is this accumulation of 

evidence of reproducible effects in multiple studies that is critical in determination of causality 

and validation of an effect and is already an integral pmi of the EPA process of supporting 

causality. 1" 

Through these different methods, the original findings of the llarvard Six Cities Study 

have been validated many times over. and they have been used to inform countless EPA rule 

rnukings that address particulate matter pollution. Notably. however, the Proposal would appear 

to preclude EPA ti"om using them because---while the Study has been reanalyzed and 

reproduced-the underlying data is not publicly available because of patient confidentiality 

protections bound by individual contractual agreements between the scientists and the research 

participants and by the llealth lnsuram;e Po11ability and Accountability Act. These reasons an: 

unrelated to the validity. integrity or quality of the Harvard Six Cities Study. Indeed, the Office 

of Management and Budget"s data quality guidelines specitically point to the Harvard Six Cities 

Study as an example of how data may be validated or corroborated without public release of the 

underlying raw data. 20 It is critically important to note that reanalysis projects are not simple or 

incxpensive 21 The reanalysis ofjusllhe Harvard Six Cities Study and the i\CS CPS II took three 

years to complete and cost $899.046 in direct expenditures. 2

' without accounting f\1r costs 

incurred by Health Effects Institute f(lr oversight and review as well as staff compensation. 

In summary. reanalysis is a tool to demonstrate the robustness ol' an effect to changes in 

the statistical model underlying an analysis of a single data set. However. it is easy to develop 

methods of reanalysis that can demonstrate a different finding. Theref\lre. care must be taken to 

understand the assumptions underlying models applied in reanalysis in order to judge their 

relevance. Replication in the environmental health context is primarily limited to laboratory 

studies and. without additional information to guide a decision. provides little information that 

can be used to decide between rcplicaw studies with differing results. Reproducing effects in 

multiple studies that are not identical is the basis for almost all scicntilic decisions on 

environmental issues and should be the f(lcus of the EPA's approach to regulatory science. 

Finally. none ol"thcse issues address other key aspects of scientific quality such as 

17 EPA. NCEA. Integrated Science Assessment.fbr Particulate ,\falter. EPA/600/R-08/l39F (2009): Beelen. Rob. el 

aL. L:f.fects (?f long-term exposure to air poilU! ion on natural-cause mortality: an ana(vsis (~f 22 European cohorts 

1rithin the multicentre ESCAPE proiect. 383.9919 The Lancet 785-795 (2014 ). 18 Di, Qian. et al.. Air pollution and mortality in the Afedicare population. 3 76.26 New England Journal of Medicine 

2513-2522 (20 17). 

'''EPA. Preamble to the Integrated Science Assessments (/SA) (EPA/600/R-15/067) (2015). 

OMB "s Guidelines Ensuring and Maximi=ing the Quality. Ohjecth·ity. Utility. and /ntegritv of Information. 67 

Fed. Reg. 8.452, 8.456 (Feb. 22. 2002). 

" Comments of Daniel Greenbaum. President Health Effects Institute (HE!). on Proposed Rule EPA-IIQ-OA2018-0259 (July 17. 2018). 2: Krewski. DanieL et al .. Reanalysis (?fthe Narrard Six Cities Sl1f((l' and the American Cancl!r Society Study of 

particulate air pollution and mortalit_v, t(1otnotc on 249 Health Effects Institute (2000), 

12 
92 


33371.074

gcncralizability and bias; how these characteristics of any scicntilic study are assessed by the 

EPA directly relate to the transparency of any decisions they might make. 

I. EPA's Proposed Rule Violates Numerous Substantive Statutory Requirements. 

A. EPA Does Not Have Authority to Issue the Proposed Rule. 

Agencies are creatures of Congress; "an agency literally has no power to act ... unless 

and until Congress confers power upon it." Louisiana Pub. Serv. Comm ·n v. FCC, 476 U.S. 355, 

374 (1986); see Am. LibraryAss'n v. FCC, 406 F.3d 689,691 (D.C. Cir. 2005) ("[tis axiomatic 

that administrative agencies may issue regulations only pursuant to authority delegated to them 

by Congress."). EPA points to a smattering of statutes as allegedly authorizing the Proposal.23 

None of these authorities. however. authorize EPA to promulgate a one-size-fits-all regulation 

governing how the agency will consider science under its various statutory authorities, which is 

perhaps why EPA solicits comment on whether additional authorities might exist to authorize its 

Proposal. The varied statutes that the Proposal cites have different requirements as to the 

agency's obligations when considering science. Compare CAA § J08(a) (standards must '·rctlect 

the latest scientific knowledge useful in indicating" health and welfare effects)24 with TSCA § 

4(1) (Administrator must consider "any other infiJrmafion available"f 5 with Safe Drinking Water 

Act ("SOW A'')§ J412(b)(l )(B)(ii)(ll) (Administrator must consider ''the best available public 

health information").26 The Proposal gives no explanation of how any of the provisions it cites 

provide authority for the Proposal, much less how all of them authorize identical requirements. 

For example, EPA cites the Clean Air Act,§ 30!, 42 U.S.C. § 7601, as purpmtedly 

granting authority for the Proposal. 27 The authority granted by section 30 I (a), however, applies 

only to the Clean Air Act and, in any event, is not broad enough to encompass this Proposal. 

Section 301 provides that ·'[l]he Administrator is authorized to prescribe such regulations subject 

to section 307(d) as are necessarv to carry out his [or her] functions under this Act."18 The courts 

have consistently "decline( d) to read ... open-ended power into section 30 I :m and instead have 

required that regulations promulgated under section 301 be both necessary and appropriate. 30 As 

83 Fed. Reg. at 18769. 04 41 U .S.C. ~ 7408(a). 

OS 15 U.S.C. ~ 2603(1). 

"42 U.S.C. ~ 300g-1(b)(1)(B)(ii)(ll). (b)(I)(A)(i): see also. 42 U.S.C. ~ 300g·1(b)(3)(A)(i) ("the Administrator 

shall use ... the best available. pecr~rcvicwcd science and supporting studies conducted in accordance \Vith sound 

and objective scientific practices·'), 17 83 Fed. Reg. at 18769. 08 42 U.S.C. § 7601(a)( I) (emphasis added). 09 Nat. Res. Def Councilv. Reil(J'. 976 F.2d 36.41 (D.C. Cir. 1992). 

"'E.g. Alabama Power Co. v. Cost/e. 636 F.2d 323.403 (D.C. Cir. 1979) (finding an EPA rule unauthorized under 

section 301. and concluding that '"[a]n extension ofPSD permit requirements beyond the wording of the Act is 

there tOre neither necessary nor appropriate to carry out EPA ·s functions under the Act.")~ ,Vat. Res. Def Councilr. 

EPA, 22 F.3d 1125. 1148 (D.C. Cir. 1994) ("[Siection 301 does not provide the Administrator ·carte blanche 

authority to promulgate any rules. on any matter relating to the Clean Air Act. in any manner that the Administrator 

\Vishes:·· and instead .. a!!owjs] the promulgation of rules that are necessary and reasonable to effect tbe purposes of 

13 
93 


33371.075

discussed in more detail below, EPA's Proposal here is not necessary, and instead directly 

conflicts with several other provisions of the Clean Air Act. It is axiomatic that a "general grant 

of authority cannot trump specific statutory provisions, "3 1 

Nor does Congressional authorization to conduct orfimd research authorize EPA to 

ignore research in regulatory decision-making. Accordingly, provisions like TSCA § 10, which 

directs that the "Administrator shall , ., conduct such research, development, and monitoring as is 

necessary to carry out the purposes of this [Act],"32 and CAA § 103, which authorizes the agency 

to conduct and support research,33 plainly do not authorize the Proposal. 

B. The Proposed Rule Violates EPA's Statutory Authorities. 

Not only is there no authority for EPA's pan-statutory Proposal, the Proposal would 

violate explicit statutory commands. Though EPA admits that "[t]he best available science must 

serve as the foundation of EPA's regulatory actions."34 proposed section 30.5 would prohibit 

EPA from considering high quality and critically important scientific studies-precisely that 

"best available science''-when undertaking regulatory actions. Specifically, section 30.5 would 

prevent EPA from considering any scientific study for which the underlying "dose response data 

and models" are not "publicly available in a manner sufficient for independent validation."35 

This would be true even if that scientific study constituted "information available to the 

Administrator" in a TSCA § 4(f) rulemaking, 15 U.S.C. § 2603(1)(2); "reflect[ed] the latest 

scientific knowledge useful in indicating'' health and welfare effects in a CAA § 108 rulemaking, 

42 U.S.C. § 7408(a)(2); or reflected "the best available public health information" in a SDWA 

rulemaking. 42 U.S.C. § 300g-l (b )(I )(B)(ii)(ll), Accordingly, this proposed prohibition would 

contravene an array of statutes governing EPA's consideration of science when promulgating 

rules, such as requirements to consider the "best available science" when setting environmental 

protection standards. See, e.g., SDWA, 42 U.S. C. § 300g-l (b)(3 )(A) (EPA must usc "[t]he best 

available, peer-reviewed science and supporting studies conducted in accordance with sound and 

objective scientific practices'' and "[ d]ata collected by accepted methods or best available 

methods''); TSCA, 15 U.S.C. § 2625(h) ("[T]he Administrator shall use scientific information, 

technical procedures, measures, methods, protocols, methodologies, or models, employed in a 

manner consistent with the best available science."); CAA, 42 U.S.C. § 7408(a) (EPA shall 

establish air quality criteria that ''shall accurately reflect the latest scientific knowledge useful in 

indicating the kind and extent of all identifiable effects on public health or welfare which may be 

the Act.") (quoting Citi=ens to Sm•e Spencer Counfy r. EPA. 600 F.2d &44, 873 (D.C. Cir. 1979)): Nat. Res. De( 

Counci!r. EPA, 749 F.3d 1055. 1063 (D.C. Cir. 2014) ("[W]e have consistently held that EPA's authority to issue 

ancillary regulations is not open-ended, partkularly when there is statutory language on point.''}: North Carolina 1'. 

EPA. 531 F.3d 896, 922 iD.C. Cir. 2008), on rei! 'gin parr, 550 F.3d 1176 (D.C. Cir. 2008) (striking down a 

regulation promulgated under Section 301 because EPA could not demonstrate that it was '"necessary'" to fulfill the 

purposes of the Act). 31 Nat. Res, De( Counci/1·. EPA, 749 F.3d 1055, 1063-64 (D.C. Cir. 2014): API 1'. EPA, 52 F.3d 1113, J 119 (D.C. 

Cir. 1995) (same). 

15 U.S.C. ~ 2609(a), cited at &3 fed. Reg. at 18769. 33 42 U.S.C. * 7403. cited at 83 Fed. Reg. at 18769. 

83 Fed. Reg. at 18769. 31 83 Fed. Reg. at 18773-74. 

14 
94 


33371.076

expected fi·om the presence of such pollutant in the ambient air, in varying quantities."). And, by 

excluding science that meets these statutory criteria from supporting regulations to protect public 

health and welfare, the Proposal would frustrate Congress's policy in these statutes and frustrate 

EPA from achieving its fundamental mission.36 

I. EPA's statutory authorities generally require the agency to consider all 

available data when undertaking significant rulemakings. 

As just noted. EPA's statutory authorities mandate a variety of requirements for what 

scientific information EPA must consider in rulemaking. These statutes are discussed in detaiL 

infra at Section 1.8.3. To take one example that appears in numerous statutes. including TSCA, 

CAA, SDWA, and the Endangered Species Act, Congress has often required agencies to act on 

the '"best available science.'' For an agency to comply with this obligation, the agency must at 

least consider all available scientific information. ''Best" means "of the most excellent, effective, 

or desirable type or quality."37 "Available" means "able to be used or obtained."38 And "science'' 

means ·'the intellectual and practical activity encompassing the systematic study of the structure 

and behavior of the physical and natural world through observation and experiment."39 Assessing 

which science is "best" requires consideration of the overall quality of the science, and the public 

availability of underlying data is. at best, one of many aspects that should inform that assessment 

of overall quality. 

An agency "cannot ignore available ... information.''40 Numerous courts have indicated 

that a plaintiff or petitioner can establish a violation of the ·'best available science" requirement 

by "point[ingl to any scientific evidence that the agency failed to consider."41 'The best available 

data requirement. .. prohibits [an agency] from disregarding available scientific evidence that is 

in some way better than the evidence [it] relies on.'"42 "An agency does ... have an obligation to 

deal with newly acquired evidence in some reasonable fashion." 43 EPA's proposal will result in 

EPA precluding itself from considering certain studies that are ''available," thus violating the 

requirement that EPA rely on the best available science. 

In addition, the requirement that agencies use "best available" science or information 

often means that the agency must act even if the available science or information is imperfect. 

16 See. e.g. Shays r. FEC. 528 F.3d 9!4. 9!9 (D.C. Cir. 2008) (''[W]e ·must reject administrative constructions of 

[a] statute that ti·ustrate the policy that Congress sought to implement.'") (quoting Cant'/ Air Lines, Inc v. Dep 't of 

Transp. 843 F.2d !444, !453 (D.C. Cir. !988)). 

:n Oxford .4merican Dictionarv 159 {3d cd. 201 0). 18 /J at Ill. . 

"ld at 1564. 4

° Connerr. Bwford. 848 F.2d 144!. 1454 (9th Cir. !988): San Luis & Delta-Mendota Water Aut h. v. Jewell, 747 

F.3d 58!, 602 (9th Cir. 20!4) (quoting Kem Cnty .. 450 F.3d at I 080-81 (quoting Conner 1'. B111jord, 848 F.2d 1441. 

1454 (9th Cir. 1988)). 41 Sqfari Club lnt '/ v. Sa/a:ar (In re Polar Bear Endangered Species Act Listing & Section .J(d) Rule Litig. -MDL 

No. 1993). 709 F.3d I, 9(D.C. Cir. 2013). 

"Kern Cty Farm 13ureau1'. ,11/en. 450 F.3d !072. 1080 (9th Cir. 2006) (quoting Sw. Ctr.for Biological Dil'ersily 1'. 

Babbill. 2!5 F.3d 58.60 (D.C. Cir. 2000)). 43 Catawba County r. EPA. 57! F.3d 20,45 (D.C. Cir. 2009) (quoting American/ron & Steel institute 1'. EPA. 115 

F.3d 979, 1007(D.C. Cir. 199!)). 

15 
95 


33371.077

"Even if the available scientific and commercial data were quite inconclusive, [the agency] 

may-indeed must-still rely on it" when the agency has a duty to act."4 "[Wjhere the 

information is not readily available, we cannot insist on perfection."45 Just as the Courts have 

recognized that they cannot expect perfection, agencies cannot choose to ignore certain studies or 

sources of information based solely on whether the data is publicly available-especially where 

the validity of those studies has been established using techniques that do not rely on public 

availability of underlying data. 

EPA cannot reasonably elevate the interest in public availability of all underlying 

information above all other factors in assessing the '·best available science." Textually, EPA's 

approach is unlawfu I. 

2. The proposal violates these statutory commands bv requiring EPA to 

ignore science when undertaking significant rulemakings. 

In direct violation of statutory requirements to consider, for example, ·'any other 

information available" or "the latest scientific knowledge [that is) useful" or ·'best available 

science," the Proposal would prohibir EPA from considering relevant and high quality science 

whenever the underlying data for a study is not publicly available. Through the Proposal, EPA 

unlawfully tries to engraft an additional statutory requirement onto each of these statutes, 

requiring that to be considered a study's underlying data must be publicly available 46 For EPA's 

Proposal to succeed, EPA must demonstrate that a study cannol be "other information available 

to the Administrator" or the ''latest scientific knowledge useful in indicating'' health or welfare 

effects or the "best available science," or any of a number of other statutory formulations if the 

underlying data is not publicly available. EPA's Proposal fails to do so, and it could not do so. 

As explained infi'a at Section II.A.l, there are many reasons that underlying study data 

may not be available that have no bearing on the quality or validity of the study. These include 

legal restrictions or concerns about privacy (especially with respect to studies involving human 

subjects), confidentiality, confidential business information. or national security. Further, if this 

requirement were applied retroactively to existing studies. it may no longer be possible to make 

underlying data and models publicly available. EPA acknowledges these impediments in 

proposed section 30.9, which provides the Administrator with discretion-but not an 

obligation-to allow the agency to consider a study for which underlying data or models are not 

publicly available if he determines that public disclosure is infeasible. But where the 

Administrator fails to exercise his discretion to grant an exemption pursuant to proposed section 

30. 9, or where data or models are unavailable for reasons that do not satisfy the infeasibility 

standard, proposed section 30.5 would prohibit EPA from considering such studies, regardless of 

whether they meet the statutory criteria for consideration. 

The only way that this prohibition could comport with EPA's statutory obligations is if a 

study for which underlying data is not available cannot be, for example, "other information 

44 Southwest C'!r. for Biological Diversity v. Babbitt. 215 F.3d 58. 60 (D.C. Cir. 2000) (quoting Citv of Las Vegas v. 

l.ujan, 891 F.2d 927,933 (D.C. Cir. 1989)). 

·

15 San Luis. 747 f.3d at 602. 

See Nat'/ Ass 'n !lf Homebuilders v. Defenders of Wildlife. 551 U.S. 644. 663-64 (2007). 

16 
96 


33371.078

available" or "the latest scientific knowledge [that is] useful" or "best available science"-i.e., if 

the public unavailability of a study's underlying dose response data and models makes the study 

ineligible to meet these criteria, regard less of whether the study has been peer reviewed, is based 

on rigorous methodologies, or has been published in a leading journal, and regardless of the 

reason for the public unavailability. EPA makes no such demonstration-nor could it. There is 

simply no support for such a proposition; to the contrary, all of the evidence shows that studies 

may be "best available science," and certainly "other information available" regardless of 

whether the data underlying them is publicly available. 

What the Proposal fails to recognize is that disclosure of data addresses only one method 

of validating scientific research-and a relatively less important aspect at that. Disclosure of data 

for a given study-the focus of the Proposal-permits independent researchers to determine 

whether the data and methodology used in that studv can be applied to generate the same results. 

This may help protect against sources of error or misrepresentation in a particular study. 

However, both EPA and independent researchers have recognized that such reanalysis does not 

by itself validate a particular study47 Rather, a study's evidentiary weight rests both on the 

strength of its methodology, as well as whether similar results can be obtained by applying the 

study's methodology to a relevant, but different dataset or population, or by using a distinct 

methodology to interrogate the same hypothesis." 8 

a) The scientific community 

Publication in a peer-reviewed scientific journal is the way that scientists communicate 

their findings to other scientists and is considered the hallmark of scientific quality. Notably, the 

editors in chief of the world's top scientific journals have notified EPA that "[i]t does not 

strengthen policies based on scientific evidence to limit the scientitlc evidence that can inform 

them; rather, it is paramount that the full suite of relevant science vetted through peer review, 

which includes ever more rigorous features, inform the landscape of decision making."49 In 

response to EPA's Proposal, the editors-in-chief of Science and Nature, and other leading 

scientists explained that though "[d]ata sharing is a feature that contributes to the robustness of 

published scientific results ... in not every case can all data be fully shared."5° For example, tl.ill 

n S'ee EPA. Preamble to the Integrated Science Assessment at 20 (20 15) ("An inference of causality is strengthened 

when a pattern of elevated risks is ohscrved across several independent studies. The reproducibili~y nffinding'i· 

constitutes one ofthe strongest arguments for causality ..... ) (emphasi:-; added): National Academies. Principles and 

Obstacles for Sharing Data From Environmental Health Research 6 (20 I 6) (quoting researcher Lynn Goldn1an 's 

observation that reproducibility and replicability across independent studies- as distinct from reanalysis of a single 

set of data using the same methodology- are the most convincing ways of validating a research finding); Lynn R. 

Goldman & Ellen Si!bcrgeld, Correspondence on Access to Chemical Data Used in Regula!or'}1 Decision ;\4aking. 

121 Environmental I lealth Perspectives A I I I (Apr. 2013 ). https:i/chp.niehs.nih.gov/wpcontent/uploadsll21/4/ehp. l206438.pdf(''Rep!ication in science is quite different: it involves perfbrmance of an 

independent study with the same hypothesis and then testing tbe extent to which this independent study reaches the 

same conclusions ... Designing and conducting a replication study does not require access to raw data tJ·om the 

original study: this would abrogate the concept of independence.") 48 See National Academies. Principles and Obstacles at 6. 49 Jeremy Berget al.. Joint Statement on J;PA Proposed Rule and Public Availability()( Data, Science (Apr. 30. 

2018). http://science.scienccmag.org/content/early/20 I 8/04/JO/sciencc.aauO l I 6. 

50 !d. 

17 
97 


33371.079

sharing is not possible when data sets include "personal identifiers."51 The scientists confirm that 

even under circumstances where underlying data cannot be made generally available, it is 

possible to evaluate the merits of a study, explaining: 

Importantly, the merits of studies relying on data that cannot be made publicly available 

can still be judged. Reviewers can have confidential access to key data and as a core skill, 

scientists are trained in assessing research publications by judging the articulation and 

logic of the research design, the clarity of the description of the methods used for data 

collection and analysis, and appropriate citation of previous resu Its. 52 

They conclude that EPA's proposal to exclude relevant studies from EPA's consideration based 

solely on the fact that underlying data or methods cannot be made available to the public "will 

adversely affect decision-making processes."53 

In a letter filed in this docket, the Presidents of the National Academies of Science, 

Engineering, and Medicine similarly observe that the public availability of data is not necessary 

to ensure the integrity of regulatory science and is not a sufficient criterion for excluding a 

particular study from consideration. The Presidents' letter notes: "The National Academies have 

developed a long-standing body of work that demonstrates scientific literature can be evaluated 

in a transparent and objective manner without complete disclosure of the underlying data." 54 

The letter goes on to explain: "If the study data are not avai !able, their absence may affect how 

the study is rated and used in the [agency's] analysis, but the study should not necessarily be 

eliminated from the assessment."55 

b) EPA policy and practice 

EPA has previously stated in several different forums that a scientific study can be valid 

even if the underlying dose response data and models are not publicly available. For example, 

EPA recently explained in its own Plan to increase Access to Results of EPA-Funded Scientific 

Research that even though "some research data cannot be made fully available to the public but 

instead may need to be made available in more limited ways." the lack offull public availability 

"does not affect the validity of the scientific conclusions from peer-reviewed research 

publications."56 Under the plan. EPA must make publications resulting from EPA-funded 

research publicly accessible on National Institute of Health's PubMed Central (PMC). 57 The plan 

!d 

52 !d 

5:< Jd. 

Letter to Acting Administrator Wheeler fi·om Marcia McNutt. President of the National Academy of Sciences, 

C.D. Mote, Jr., President of the National Academy of Engineering. and Victor J. Dzau. President of the National 

Academy of Medicine 2 (July 16. 2018). 

http://www.nationalacademies.orglincludcs/EP A %20Proposed%20Rule%20Docket%20EP A· H Q-0 A-20 l8-

0259%20NASEM%20Comment.pdf. 

5 !d at2-3. 

EPA. Plan to Increase Access to l?esu/1s of EPA-Funded Scientific Research 4-5 (Nov. 29. 2016). 

https :I /\VW\V .epa. gov I sites/production/ tlles/20 16~ 12/ documents/ epasc i ent i li crcsearchtrn nspcran cvpl an .pd [ 57 !d. at 8. 

18 
98 


33371.080

aims to "maximize access, by the general public and without charge, to digitally formatted data 

resulting from EPA funded research, while protecting confidentiality and personal privacy, 

recognizing proprietary interests, business confidential information and intellectual property 

rights, and preserving the balance between the relative benefits and costs of long-term 

preservation and access. "58 The plan recognizes important exceptions for when ··the research 

data cannot be released due to one or more constraints, such as requirements to protect 

confidentiality, personal privacy, proprietary interest, or property rights."59 It specifically 

declares: "The validity of scientific conclusions drawn from research publications or their 

associated research data, or EPA's ability to consider those conclusions and data in its actions, 

does not depend on compliance with this Plan."60 

Likewise, EPA's Science Policy Council explains in A Summary of General Assessment 

Factors for Evaluating the Qualizv of Scientific and Technical Information that EPA's 

determination as to the quality and reliability of a particular scientific study docs not depend on 

one single factor (e.g., the public availability of underlying data), but instead turns on the 

agency's consideration of five general factors. 61 Congress implicitly endorsed this approach by 

including a directive for EPA to use these same five factors in evaluating science under the Toxic 

Substances Control Act Amendments passed in 2016,61 and just last year this Administration 

included these same factors in a recent regulation implementing TSCA.63 The factors comprise: 

(I) soundness; (2) applicability and utility; (3) clarity and completeness; (4) uncertainty and 

variability; and (5) evaluation and revicw64 Of these, the only ones with any possible direct 

relevance to EPA's proposed approach are the third and fifth factors, but neither supports the 

elevation of public availability of data above all other considerations or the exclusion of studies 

with non-public data. The third factor. "clarity and completeness'' requires EPA to consider 

"[t]he degree of clarity and completeness with which the data. assumptions, methods, quality 

assurance, sponsoring organizations and analyses employed to generate the information are 

documented." The fifth factor, "evaluation and review," requires EPA to consider "[tjhc extent 

of independent verification, validation and peer review of the information or of the procedures, 

measures, methods or models." Even clear and complete "documentation" ofthe data used does 

not require that the data be made publicly available. Nor does factor five require either that a 

study's findings must have been replicated using the same data, or that the data must be available 

"!d. at II (emphasis added). 

50 /d. 

60 !d. at 6. 61 EPA Science Policy Council, A Surnmm:v of General Assessmeni Factors for Evaluating the Qualify ofScient{/ic 

and Technical if?[ormation. EPA 100/B-03/001 (.June 2003) https://www.epa.gov/risk/summary~general~asscssmentfacto rs~cva! uating-g ual ity-scienti tl c-and-technical-i n formation. 

"/d. at 7. 61 EPA Science Policy Council. A Summmy of General "~ssessment Factors for Emluating the Quality ofSciemific 

and Technical Information: 15 U.S.C. * 2625(11)(1)-(5); 82 Fed. Reg. 33.726.33.731 (July 20. 2017). 42 U"S.C. * 

300g-l(b)(3 )(A). 

M Note that TSCA and the regulations do not include the headers for the tive factors ( .. soundness," "applicability 

and utility," etc.) included in the Science Policy Council guidance. but the description of each factor to be 

considered is largely identical. 

19 
99 


33371.081

to allow for such replication. Moreover, these are only portions of two of five key factors to 

consider.65 

Similarly, EPA's Guidelines for Ensuring and Maximizing the Quality, Objectivity, 

Utility and Integrity of the Information Disseminated by the Environmental Protection Agency,66 

CEPA Information Quality Guidelines") issued pursuant to Section 515(a) of the Treasury and 

General Government Appropriations Act for Fiscal Year 2001 (Public Law 106-554; H.R. 5658) 

(the "Data Quality Act") make it clear that the public unavailability of underlying data or models 

does not render a study inappropriate for EPA's consideration. Specifically, the EPA Information 

Quality Guidelines acknowledge that even with respect to science that will have "a clear and 

substantial impact on important public policies or private sector decisions:' there will be 

circumstances where "access to data and methods cannot occur due to compelling interests such 

as privacy. trade secrets, intellectual property, and other confidentiality protections."67 

Significantly, the Guidelines do not instruct EPA to ignore such science. Rather, the Guidelines 

instruct that if underlying data or methods are unavailable, "EPA should, to the extent 

practicable, apply especially rigorous robustness checks to analytic results and carefully 

document all checks that were undertaken."68 The Guidelines further explain: "Original and 

supporting data may not be subject to the high and specific degree of transparency provided for 

analytic results; however, EPA should apply, to the extent practicable, relevant Agency policies 

and procedures to achieve reproducibility, given ethical, feasibility, and confidentiality 

constraints. ''69 

Far from instructing EPA not to consider scientific studies for which underlying data or 

models are unavailable, the EPA Information Quality Guidelines expressly acknowledge that 

EPA must balance a variety of important aims to fulfill its statutory obligations to protect public 

health and the environment. EPA explains in the guidelines that '"most environmental statutes 

obligate EPA to act to prevent adverse environmental and human health impacts" and that "ffjor 

many of the risks that we must address, data are sparse and consensus about assumptions is 

rare."70 Thus, rather than set rigid rules regarding what science and information EPA can rely 

upon in its rulemakings, EPA "seek[s] to strike a balance among fairness, accuracy, and efficient 

implementation."71 EPA states: ''Refusing to act until data quality improves can result in 

substantial harm to human health, safety, and the environmcnt."72 

As discussed infra at Section l.B.3.b)ii, even this Administration, in the context of 

promulgating regulations under TSCA, has adopted a regulatory definition of "best available 

See EPA Science Policy CounciL A Swnmmy (?lGenera! Assessment fGctorsfor Evaluating the Quali(V of 

S'cientffic and Technical h?formation. 60 EPA. Guidelinesfor Ensuring and Maximi:ing the Quality. Objectil'ily, Utility. and /me grit)• oflnf(;rmation 

f);ssl!minated hy the EPA (2002). https://www.epa.gov/gualitv/guidelines-ensuring-and-maximizing-qualityo bj ectivi t) -utility -and-i ntegritv-i nformation. 67 id at 21. 

N~ Id 

G9 /d. 

70 /d at 52. 

71 !d 

!d. 

20 
100 


33371.082

science" expressly incorporating a multi-factor analysis, and that definition recognizes that 

public unavailability of data does not render a study incapable of being '·best available science." 

c) The courts 

As EPA acknowledges in footnote 3 of the Proposal, in at least two instances the D.C. 

Circuit Court of Appeals has recognized that studies for which underlying data is not publicly 

available may constitute ''best available science."73 The D.C. Circuit's decisions in these cases 

further demonstrate that the public unavailability of a study's underlying data does not render a 

study incapable of constituting "best available science" otherwise unworthy of EPA's 

consideration. 

In American Trucking Associations v. EPA, the petitioner challenged EPA's reliance on 

scientific studies for which underlying data was not publicly available in deciding to strengthen 

the national ambient air quality standards for particulate matter.?< The Court held that the Clean 

Air Act did not require EPA to make public underlying data where EPA relied on the study itself 

and not the raw data underlying the study. The Court agreed with EPA's position that requiring 

agencies to obtain and publicize the data underlying all studies on which they rely ·'would be 

impractical and unneccssary."75 Importantly. the Court concluded that: 

If EPA and other governmental agencies could not rely on published studies 

without conducting an independent analysis of the enormous volume of raw data 

underlying them. rhen much plainly relevant scientific information would become 

unavailable to EPA for use in setting srandards to protect public health and the 

environment .... Such data are often the property of scientific investigators and 

are often not readily available because of .. proprietary interests ... or because of 

[confidentiality] arrangements [with study participants ]76 

The court accordingly recognized that ignoring relevant scientific information simply because 

the underlying data is not available would violate EPA's obligations to consider ·'best available 

science." Coalition of Ballery Recyclers Association v. EPA involved another challenge to EPA's 

reliance on a scientific study for which the underlying data was not publicly available.77 In that 

case, EPA had relied upon the study in question to determine the '·concentration-response 

relationship between blood lead levels and IQ changcs.''78 The D.C. Circuit again upheld EPA's 

reliance on studies without making the underlying data publicly available and explained, "raw 

data often is unavailable due to proprietary interests of a study's scientific investigators or 

confidentiality agreements with study participants."79 Likewise, in Ci~)' of Waukesha v. EPA the 

83 Fed. Reg. at 18769. 74 283 F.3d 355.372 (D.C. Cir. 2002). 

"ld at 372 (quoting '-Jational Ambient Air Quality Standards tor Particulate Matter. 62 Fed. Reg. 38.652. 38.689 

(July 18. 1997). 76 ld (emphasis added). 77 604 F.3d 613. 622-23 (D.C. Cir. 20 I 0). 78 /d. at 622. 7

'' !d. at623. 

21 
101 


33371.083

D.C. Circuit concluded that agency peer review satisfies the requirement to use best, peerreviewed science and supporting studies 80 

d) The Proposal 

Finally, even the Proposal appears to concede that studies for which data is not publicly 

available could constitute the "hest available science" that EPA is statutorily required to 

consider. The proposed exemption provision in section 30.9 makes it clear that EPA does not 

consider a study to be invalid or unsuitable for EPA's consideration based only on the public 

unavailability of underlying data or models. Specifically section 30.9 would give the 

Administrator discretion to authorize consideration of a scientific study where "[i]t is not feasible 

to ensure that all dose response data and models underlying pivotal regulatory science is publicly 

available." Of course, EPA could not have intended for proposed section 30.9 to provide the 

Administrator with discretion to take a study that is not "best available science" into 

consideration when promulgating a rulemaking. If the Administrator has discretion to allow 

consideration of a study for which it is infeasible to make the study's underlying data and models 

publicly availahle, then it obviously is not necessary for such underlying data and models to be 

publicly available for a scientific study to constitute "best available science." Yet, unless the 

Administrator elects to exercise his discretion under proposed section 30.9 and find that it is 

"infeasible" to make a study's underlying data and models publicly available. proposed section 

30.5 broadly prohibits EPA from relying on the study in support of"significant regulatory 

actions." 

Moreover, while proposed section 30.5's prohibition would apply to ·'pivotal regulatory 

science" used for "significant regulatory actions," the proposed rule says nothing to prohibit 

EPA's reliance on these studies for other agency purposes, such as in permitting, enforcement, or 

regulatory actions that do not qualify as "significant." Thus, EPA clearly does not believe that a 

study cannot be "best available science" based solely on the fact that underlying data and models 

are not publicly available. 

In sum, if finalized, EPA's proposed rule would restrict EPA's ability to consider ·'best 

available science" when undertaking significant rulemakings, contrary to the numerous statutory 

directives discussed in detail below. 

3. Bv prohibiting EPA from considering all valid and relevant studies when 

undertaking significant rulemakings, the proposed rule would prevent EPA from 

complying with an array of statutory provisions governing EPA's consideration of 

available science. 

a) The Proposal Contravenes the Clean Air Act 

80 320 F.3d 228.247 (D.C. Cir. 2003). 

22 
102 


33371.084

Under Clean Air Act section 108(a),81 EPA must establish air quality criteria for each air 

pollutant that serves as the basis for setting the national ambient air quality standards. Such 

criteria '·shall accurately reflect the latest scientific knowledge useful in indicating the kind and 

extent of all identifiable effects on public health or wei Fare which may be expected from the 

presence of such pollutant in the ambient air, in varying quantities."81 As explained above, the 

scientific community, EPA, and the courts have all concluded that lack of public availability of 

underlying data does not render the study invalid. And, consideration of such studies can be 

essential for EPA to fulfill Clean Air Act section 108(a)'s directive that it consider "the latest 

scientific knowledge" in establishing air quality criteria, that it consider studies ''useful" in 

indicating effects of pollutants on ambient air, and in providing an adequate margin of safety in 

the standard itself. 83 Thus, EPA's proposal to bar EPA from considering such studies would 

prevent EPA from complying with its statutory obligation under Clean Air Act section l 08(a). 

Section I 08(a)(2) says nothing about excluding information-its evident purpose is to be 

inclusive as to information to be considered. EPA's historic practice reflects this broad directive: 

each NAAQS review evaluates virtually all studies in the area, excluding none. but assigning 

appropriate weight based on study-by-study evaluation. Since the NAAQS provisions were 

enacted in 1970, EPA has conducted many NAAQS rulemakings. The agency does not establish 

per se, a priori rules regarding study inclusion or exclusion. but rather evaluates each of the 

individual studies-and there are thousands typically evaluated for each NAAQS review-on 

their merits based on reasoned criteria. While details of the development and review of the 

criteria and standards have evolved over time, in practice, EPA has endeavored to include all 

relevant scientific studies in the process, even providing provisional assessments of relevant 

literature that appears after the formal scientific review has been completed. Over the years, tens 

of thousands of peer-reviewed studies of health effects, exposure, and atmospheric interactions, 

and monitoring have been included in reviews of criteria and standards. A requirement that they 

must be excluded from consideration unless the raw data and full methodologies are made 

available for all of them is inconsistent with the !egis!at(ve mandate and EPA's practice over the 

last 40 years. 

Thus, a science regulation that applies to the NAAQS is unlawful unless EPA can show 

that the new standard can be established and implemented consistent with the applicable 

statutory requirements. To do so, EPA must prove that public unavailability of data means that a 

study does not constitute ''latest scientific knowledge useful" in indicating etfects on human 

health or wclfare. 84 EPA's Proposal neither acknowledges this requirement nor explains how the 

Proposal would not violate this statutory command. 

31 42 li.S.C. § 740R(a). 82 42 U.S.C. § 7408(a)(2). 

83 !d. 

3

' 42 U.S.C. § 7408(a)(2). 

23 
103 


33371.085

For example, in past NAAQS reviews, EPA has considered the Harvard Six Cities 

studl5 and American Cancer Society studies86, despite the fact that the data underlying these 

studies is not publicly available. These studies, however, arc plainly "useful in indicating the 

kind and extent of all identifiable effects on public health or welfare."87 These seminal studies 

have been part of the air quality criteria since the mid-1990s-thcy have thus been accepted as 

"useful" by separate panels ofCASAC, and by EPA, in three separate NAAQS reviews. Their 

use has been upheld by the D.C. Circuit.88 Both studies have been reanalyzed and validated by 

highly competent third-party reviewers (the Health Effects Institute) with access to the 

underlying data. ~ The study results have been reproduced many times over. 90 Extended followup analyses of the ACS and Harvard Six Cities studies provide consistent and stronger evidence 

of an association with PM 2.5 and mortality at even lower air quality distributions than had 

previously been observed.91 This type of cumulative weight of evidence is highly probative in 

assessing both causality and in establishing the level of the NAAQS. 92 The proposal says almost 

nothing about any of these other attributes that not only make these studies "useful," but indeed 

make them particularly high quality and reliable. 

The primary ozone NAAQS provides further examples of the pernicious effects the 

proposal would have. Among the key controlled human exposure studies demonstrating that 

exposure to ozone causes adverse health effects in even healthy subjects at levels below the level 

of the then-current NAAQS are Adams (2006) and Schelegle (2009).93 These studies were 

sponsored by the American Petroleum Institute. which controls access to the underlying data. 

The American Petroleum Institute refused an EPA researcher access to the data of a related 

Dockery. D.W .. Pope. C.A .. Xu. X .. Spengler. J.D .. Ware. J.H .. Fay. M.E.. Ferris Jr. 13.G. and Speizer, F.E .. An 

association between air pollution and mortali~v in six US cities. 329(24) New England Journnl of Medicine 1753-

1759 (1993). 

"'Pope. C.A .. Thun, M . .l.. Namboodiri. M.M .. Dockery, D.W .. Evans. J.S., Speizer. F.E. and lleath. C.W .. 

Particulate air pollution as a predictor ofrnorta!i(y in u prospectil·e s/11(6' of US adults. 151(3) American Journal of 

Respiratory and Critical Care Medicine 669-674 ( 1995): Krewski. D .. Jerrett. ,vl., Burnett. R.T .. Mo, R .. Hughes. E.. 

Shi. Y .. Turner. M.C .. Pope. C.A. Ill. Thurston. G .. Calle. E. E .. Thun, M.J .. Ex/ended Follmr-up and Spatial 

Analysis (~(the American Cancer Sacie(v ,')'tudy Linking Particulate A;,· Pollution and Afortality. 140 Health Effects 

Institute. 13oston. MA (2009). 

"CAA section 108 (a)(2). 42 U.S.C'. P408(a)(2). 38 Coalition ofBa/!eJy Recyclers Ass'nl'. t:Pll. 604 F.3d at 623. 3

'

1 KrC\\SkL DanieL et aL Reanaly.'>·is of the 1/an·ard Six Cities Study and the American Cancer Socii!!) Study of 

Particulate Air Pollwion and ,>fortaliry.llealth Ertects Institute. Cambridge. MA (2000). 

')I) 5'ee EPA. NCEA. Jnregratcd Science :lssessrnentfor Particulate ,\fatter (EP/\/600/R-08/139F). 7-86 (2009). 

')J ~\ee EPA, Policy Assessment for tht: Rel·iell' oft he Particulate A1atler i'.iational Ambient Air Quality Standard 

(EPA 452/R-11-003 ). 2-31 to 33 (Apr. 2011 ). See also Memorandum by Alison Cullen. Chair. SAI3 Work Group on 

EPA Planned Actions J<)f SAB Consideration of the Underlying Science at 4 (May !2. 20 18) (noting that "additional 

studies have confirmed the basic findings" of the Six Cities and American Cancer Society studies and that .. the 

rigorous fbrm of peer revievv and independent reanalysis'' applied ·'has accomplished a measure of confidence in 

findings v.~ithout public access to data and analytic methods."'), 

Stale of Mississippi r. EPA. 744 F.3d 1334. 1344 (D.C. Cir. 2013) (endorsing EPA's weight of evidence approach. 

and stating that "incremental (and arguably duplicative) studies arc valuable precisely because they confirm or 

quality previous lindings or otherwise decrease uncertainty''). 91 See EPA. Policy Assessment for the Review qfthe O:.one lv'ntional Ambiel1f ·Dr Quulily Standards (EPA ~452/R14-006. 3-27.4-10 (Aug. 2014). 

24 
104 


33371.086

Adams study it sponsored (Adams (1998)). 94 So not only would these evidently "useful'' (under 

CAA section I 08(a)(l)) studies be barred from consideration under the Proposal, but the 

Proposal creates a perverse incentive for industry to refuse access to study data. The published 

studies- peer reviewed-would obviously be providing information ·'useful" in indicating 

effects of air pollution, but the Proposal would not only bar their consideration but create an 

incentive tor industry never to provide underlying data for any industry-sponsored study with a 

result not to industry's liking. 

The most recent premiere long-term cohort study for PM is Domenici (20 17) which 

found even greater effects of fine particles at levels below EPA's current standards.95 This study 

used a Medicare database available to any research group that can guarantee confidentiality of 

personal data. 96 Yet the proposal could evidently bar consideration of this powerful study.97 

NAAQS must be requisite to protect the public health, and to provide an ·'adequate 

margin of safety" in doing so.98 The proposal violates this central statutory requirement. 

NAAQS are required to provide this margin of safety "to build a buffer to protect against 

uncertain and unknown dangers to human health."99 EPA's Proposal would build a buffer against 

using the very studies necessary to guard against these dangers. 100 

b) EPA's Proposal contravenes the Toxic Substances Control Act 

(TSCA). 

i. TSCA expressly requires that EPA consider reasonably available 

information and EPA 's proposal would preclude EPA from 

considering some reasonably available information. 

When Congress amended TSCA through passage of the Frank R. Lauten berg Chemical 

Safety for the 21st Century Act (Lauten berg Act), Congress provided a number of detailed 

instructions on how EPA should consider scientific information with respect to chemical 

substances; EPA's proposal contradicts Congress's carefully crafted scheme. In particular, 

Congress included a provision specitlcally requiring that EPA consider all "reasonably available 

94 5'ee EPA, First F .. xternal Re1•iew Drqft Integrated Science Assessment for O::one and Related Photochemical 

Oxidams (EPA/600/R-10/076A). 6-7n. I (feb. 2011). 95 Qian Di ct. al.. Air Pollution and A1ortali~v in the ;'V/edicare Population. 376 New England Journal of Medicine 

2513 (2017). https:i/www.ncjm.org/doi/pdti!O.l056/NEJMoal702747. 06 See CMS. Limited Data Set (LDS) Files, https://www.cms.gov/Rcscarch-Statistics-Data-and-Systcms/Files-torOrdcr/Data-Disclosures-Data-Agreements!DUA - NewLDS.html (last accessed Aug. 9. 2018) (noting data requires 

a signed data use agreement and data cannot be disclosed). 07 See 83 Fed. Reg. 18768. 18773. Proposed section 30.5 final sentence ("where data is controlled by third parties. 

EPA shall work with those parties to endeavor to make the data available in a manner that complies with this 

section"). There appears to be some interaction required before third party studies are considered to be publicly 

available. 

08 CAA section l09(b): 42 U.S.C. * 7409(b). 90 Stale of Mississippi. 744 F.3d at !353. 100 See American Farm Bureaur. EPA. 559 F.Jd 512,525-26 (D.C. Cir. 2009) (remanding primary Particulate 

Matter NAAQS because inadequate consideration of certain epidemiologic studies resulted in a standat·d lacking an 

adequate margin ,,f salety). 

25 
105 


33371.087

inf(Jrmation." 101 When making decisions about testing or the risk evaluation or regulation of new 

or existing chemicals, "the Administrator shall take into consideration information relating to a 

chemical substance or mixture, including hazard and exposure information, under the conditions 

of use, thar is reasonab~v available ro the Administrator." IS U.S.C. § 2625(k) (emphases 

added). But under EPA's proposed rule, EPA would often be precluded from considering such 

reasonably available information if all the underlying data and models were not publicly 

available. See 83 Fed. Reg. at 18,769 n.3 (stating that proposal '·would preclude [EPA] from 

using [non-public J data in future regulatory actions"). EPA's proposal violates the plain language 

ofTSCA § 26(k), as well as Congress's clear purpose of ensuring that EPA consider all 

reasonably available information relating to a chemical when making a decision about the 

chemical. 

Under its plain language, "available" means ''able to be used or obtained; at someonc's 

disposal." 102 Congress chose this standard to ensure that EPA would make decisions based on all 

reasonably available information. S. Rep. No. I 14-67 at 9 (June 18, 20 I 5) ('The section ... 

requires EPA to consider reasonably available information about potential hazards and exposures 

of a chemical substance under the conditions of use when making decisions under TSCA .... The 

Committee intends that EPA systematically search for and identify relevant information that is 

available to inform safety assessments and determinations."); Oversight of the Environmental 

Protection Agency's Progress in Implementing Inspector General and Government 

Accountability Office Recommendations: Hearing before the Subcomm. on Superfund, Waste 

Management, and Regulatory Oversight of the S. Comm. on Environment and Public Works, 

!14th Cong. at 63 (June 14, 2016) ("[F]or the EPA to properly evaluate and regulate toxic 

substances, it is essential that they have the most up-to-date chemical and toxicity data 

available.''). Congress also selected this standard to avoid paralysis by analysis-Congress 

wanted EPA to act on available information and not to postpone action waiting for new or 

perfect information to become available. See, e.g, 162 Con g. Rec. S35 I L S35 17 (daily ed. June 

7, 20 16) (referring to "information reasonably available to EPA" as ''ensur[ing]that such 

considerations do not require additional information to be collected or developed"). ''Congress 

recognized the need to use available studies, reports and recommendations for purposes of 

chemical assessments rather than creating them from whole cloth.'' 1d at S3522. And Congress 

intended for EPA to consider studies even when they had not undergone all possible forms of 

vetting. "[l]n instances where there were other studies and reports unavailable at the time of the 

[National Academy of Sciences] recommendations, EPA should take advantage of those studies 

and reports in order to ensure that the science used for chemical assessments is the best available 

and most current science." /d. at S3522. Congress intended for EPA to consider all reasonably 

available information, and EPA's proposal would thwart that clear purpose. 

Notably, this Administration has adopted two regulations under the amended TSCA 

defining reasonably available information. These regulations generally provide that: 

Reasonably available information means information that EPA possesses or can 

reasonably generate, obtain, and synthesize f(ll' use in risk evaluations. considering the 

deadlines specified in TSCA [for action]. Information that meets the terms of the 

101 Pub. L. No. 114-182. ~ 17(k). 130 Stat. 448, 502 (June 22. 2016) (codilied at 15 U.S.C. ~ 2625(k))_ 

w: Oxford American DiclionmJ·l1J (3d ed. 2010). 

26 
106 


33371.088

preceding sentence is reasonably available information whether or not the information is 

confidential business information, that is protected from public disclosure under TSCA 

section 14. 

40 C.F.R. § 702.33; see also 40 C.F.R. § 702.3 (similar definition for prioritization decisions). 

This bears no resemblance to the limitations put forward in the Proposal. Indeed, EPA has 

defined "reasonably available information" to include information EPA withholds as 

Confidential Business Information (CBI) under TSCA § 14. 15 U.S.C. § 2613. lfthe proposed 

rule forecloses EPA from considering information that cannot be fully disclosed, as it appears to 

do, then EPA cannot comply with both these regulations and the proposed rule. 

EPA's proposal also violates other provisions ofTSCA that expressly require EPA to act 

on '·available information." For example, in preparing risk evaluations for existing chemicals, 

EPA "shall integrate and assess available information on hazards and exposures for the 

conditions of use of the chemical substance, including information that is relevant to specific 

risks of injury to health or the environment and information on potentially exposed or susceptible 

subpopulations identified as relevant by the Administrator.'' 103 Under the proposed rule, EPA 

would not be able to integrate and assess available information where all underlying data has not 

been disclosed. Similarly, when developing regulations for existing chemicals, EPA "shall 

consider and publish a statement based on reasonably available injimnation with respect to" a 

number of factors, including the effects of the chemical on health and the environment. 104 But 

under the proposed rule, EPA cannot consider all reasonably available information when 

assessing those health and environmental effects. 

Indeed. TSCA § 4(1) imposes a duty upon EPA to initiate regulation in response to any 

available information that meets certain substantive standards. However, if all the underlying 

information were not available, EPA's proposed rule would then foreclose EPA from 

considering that information during the resulting rulemaking. Congress would not have created a 

scheme where EPA must act in response to certain information but then cannot consider that 

information in taking action. Speciftcally, under TSCA § 4(1): 

Upon the receipt of-( I) any injimnation required to be submitted under this Act, or 

(2) any other informal ion available to the Administrator-which indicates to the 

Administrator that there may be a reasonable basis to conclude that a chemical substance 

or mixture presents a significant risk of serious or widespread harm to human beings, the 

Administrator shall, ... initiate applicable action under section 5, 6, or 7 to prevent or 

reduce to a sufficient extent such risk or publish in the Federal Register a finding, made 

without consideration of costs or other non risk factors, that such risk is not 

unreasonable. 105 

Thus if"any ... information available" to EPA provides a reasonable basis to conclude that a 

chemical''presents a significant risk of serious or widespread harm to human beings," then EPA 

must initiate action to regulate the chemical. But under EPA's proposed rule, EPA would then be 

101 15 U.S.C. § 2605(b)(4)(F)(i) (emphasis added). 

"" ld R 2605(c)(2)(A) (emphasis added). 105 15 U.S.C. § 2603(t) (emphases added). 

27 
107 


33371.089

required to ignore the information triggering this duty when crafting the final regulation unless 

the source of the information fully disclosed all underlying data. That result clearly contradicts 

Congress's intent, which was to create a duty for EPA to react to any available information 

meeting the substantive standard ofTSCA § 4(1). 

In sum, Congress repeatedly directed EPA to consider all reasonably available 

information when making decisions under TSCA. The proposed rule would illegally preclude 

EPA from considering available information. The two cannot be reconciled, and the rule is 

unlawful. 

ii. TSCA requires an agency to act on the "'best available science," 

meaning that EPA must consider all available science and assess 

the quality of the science based on a variety a./factors. 

EPA's proposed blanket prohibition against basing a rulemaking on science for which 

underlying data or models are not publicly available would be particularly hard to reconcile with 

the "best available science" standard as articulated in TSCA, which clearly contemplates a caseby-case analysis in which EPA weighs a variety of factors when identifying the best available 

science. The relevant provision of TSCA requires that: 

(h) Scientific standards. In carrying out sections 4, 5, and 6, to the extent that the 

Administrator makes a decision based on science, the Administrator shall use scientific 

information, technical procedures, measures, methods, protocols, methodologies, or 

models, employed in a manner consistent with the best available science. and shall 

consider as applicable-

(!) the extent to which the scientific information, technical procedures. measures. 

methods, protocols. methodologies, or models employed to generate the information are 

reasonable for and consistent with the intended use of the information; 

(2) the extent to which the information is relevant for the Administrator's use in making a 

decision about a chemical substance or mixture; 

(3) the degree a_[ clarity and completeness with which the data, assumptions, methods, 

quality assurance, and analyses employed to generate the information are documented; 

(4) the extent to which the variability and uncertainty in the information, or in the 

procedures, measures, methods, protocols, methodologies, or models, are evaluated and 

characterized; and 

(5) the extell/ of independent verification or peer review of the information or of the 

procedures, measures, methods, protocols, methodologies, or models. 10" 

Thus, Congress provided EPA with factors to guide its consideration of the "best available 

science." and Congress did not make the public disclosure of all underlying data a requirement 

for material to be the "best available science." Quite the opposite; Congress included aspects of 

disclosure and independent review as parts of factors to be considered when weighing scientific 

information. But these are just aspects of five different factors to be weighed ·•as applicable," and 

106 15 U.S. C. ~ 2625(h) (emphases added). 

28 
108 


33371.090

Congress clearly contemplated that EPA would sometimes rely on science that does not meet the 

proposed rule's requirement of full disclosure of all underlying data. 

First. Congress directed EPA to consider these factors when weighing particular 

information; Congress specifically did not develop (or direct EPA to develop) bright-line criteria 

for eliminating information from consideration entirely. Thus. each factor includes the phrase 

"degree o!" or "extent to which," without identifying any threshold that would be disqualifYing. 107 This shows that Congress intended these factors to help EPA assess the weight information 

should be given based on its relative scientific reliability, not to create minimum thresholds of 

reliability below which information must be ignored by EPA altogether. For EPA to insert a 

screen on top of these factors--excluding information where the underlying data and models are 

not publicly available as required by the proposed rule--contradicts Congress's unambiguous 

intent about how EPA should approach its assessment of the best available science. 

Second, Congress made the "degree of clarity and completeness" with which the 

underlying data is documented to be part of one factor for EPA to consider in evaluating whether 

a particular study is the "best available science." 108 But EPA must also consider ·'the degree of 

clarity and completeness'' with which "assumptions, methods, quality assurance, and analyses'' 

are documented as weii.H19 Thus, Congress contemplated that EPA would still rely on some 

studies that did not document completely all the underlying data, much less disclose all of that 

information. 

Third, Congress made ·'the extent of independent verification or peer review of the 

information or of the procedures, measures, methods, protocols, methodologies, or models" 

another factor to be weighed when considering whether information is the "best available." 110 

Notably, Congress's choice of the disjunctive "or" reflects that "peer review" can be an adequate 

alternative to ''independent verification," and Congress did not require that either "independent 

verification or peer review·· be accomplished through public availability of data as required in 

the proposed rule. Moreover, Congress contemplated scenarios where EPA would give more 

weight to evidence even if the "information" had not undergone "independent verification or 

peer review'' based on the extent to which the "procedures, measures, methods. protocols, 

methodologies. or models" had done so. 

Fourth and most importantly. EPA cannot rationally elevate the interest in public 

disclosure of all underlying data above all the other factors that Congress expressly required EPA 

to consider in evaluating science. Congress required EPA to consider these five factors "as 

applicable" when weighing information. and Congress did not make full public availability of 

underlying data one of the factors. much less a decisive or absolute one. 

107 See. e.g 15 U.S.C. ~ 2625(h)( I) ("!he extent /o which the scientific inf(Jrmation .. [are] consistent with the 

intended use of the information··) (emphasis added}. 108 15 u.s.c. ~ 2625(h)(3 ). 

109/d 

1

" 1 15 U.S.C. ~ 2625(h)(5). 

29 
109 


33371.091

This administration recently adopted a regulatory definition of"best available science" 

for purposes ofTSCA which expressly incorporated consideration of these five factors and was 

otherwise inspired by use of the term in the Safe Drinking Water Act (SDWA). 111 EPA defined 

the phrase: 

Best available science means science that is reliable and unbiased. Use of best available 

science involves the use of supporting studies conducted in accordance with sound and 

objective science practices, including, when available, peer reviewed science and 

supporting studies and data collected by accepted methods or best available methods (if 

the reliability of the method and the nature of the decision justifies use of the data). 

Additionally, EPA will consider as applicable: 

[TSCA § 26(h)(l)(5) factors] 112 

According to EPA in selecting this definition, "the Agency is remaining consistent with 

the current approach already used Agency-wide, while also acknowledging the specific standards 

under TSCA." 113 Notably, this definition does not require public disclosure of all underlying data 

for science to be the ''best available science," yet many studies that meet this definition of"best 

available science" would be excluded under EPA's proposed rule. 

EPA's Proposal cannot be reconciled with EPA's existing definition of best available 

science, with decades of court and agency precedent, or with text of the statute. When a statute 

requires the agency to make a decision based on the "best available science," it would be 

unlawful to follow EPA's proposed rule. 

iii. EPA's proposed rule also contradiels TSCA 's requirement that 

decisions be made based on the weight t!f the scientific evidence. 

TSCA § 26(i) requires EPA to make decisions regarding testing and regulating new and 

existing chemicals "based on the weight of the scientific evidence.'' 114 If EPA excludes certain 

information, as proposed, then EPA will not be able to weigh the evidence as a whole. 

Indeed, this administration recently adopted a regulation defining "weight of scientific 

evidence" to mean ·•a systematic review method ... that uses a pre-established protocol to 

comprehensively, objectively, transparently, and consistently, identify and evaluate each stream 

ofevidence, including strengths, limitations, and relevance of each study and to integrate 

evidence as necessary and appropriate based upon strengths, limitations, and relevance.'' 115 

Systematic reviews consider the entire body of scientific evidence, but EPA's proposed rule 

would prevent EPA from conducting true systematic review because it would prohibit the 

Agency from considering studies where the data were not publicly available and it would 

111 See 82 Fed. Reg. 33.726.33.731 (July 20. 2017), 42 U.S.C. ~ 300g-l(b)(3)(A). 

"' 40 C.F.R. ~ 702.33. 113 82 Fed. R~g. at33.731. 114 15 u.s.c. § 2625(i). 115 40 C.F.R. § 702.33 (emphases added). 

30 
110 


33371.092

eliminate studies based on criteria other than their "strengths, limitations, and relevance." 116 If 

the proposed rule forecloses EPA from considering information that cannot be fully disclosed, as 

it appears to do, then EPA cannot comply with this regulation and the proposed rule. 

In sum, EPA's proposed rule is inconsistent with TSCA's plain text. EPA should not 

adopt the proposed rule because it cannot be reconciled with the agency's duties under TSCA. 

iv. Secrion 10 ofTSCA does not authorize this proposal. 

Nothing in Toxic Substances Control Act (TSCA) § I 0 authorizes EPA to exclude 

scientific information during rulemakings on any basis. Section I 0 authorizes EPA to research 

and develop information for purposes of carrying out TSCA. 117 Section I 0 also authorizes EPA 

to develop systems to collect and disseminate information about chemical subs!ances. 118 But 

TSCA § \0 is silent regarding rulemaking or EPA's use of scientific information in rulemaking. 

It does not authorize EPA to exclude scientific information on any basis; if anything, TSCA § 10 

reflects a congressional judgment that EPA should be prepared to use any and all ''toxicological 

and other scientific information which could be useful to the Administrator in carrying out the 

purposes of this [Act]." 119 

c) EPA's Proposal contravenes the Safe Drinking Water Act. 

The Safe Drinking Water Act requires EPA to issue national drinking water regulations 

setting required purity levels for water from public water supply systems. 120 Before regulating, 

the Administrator must conclude that the contaminant at issue ''may have" an adverse effect on 

the health of persons. 111 In regulating, the Administrator must consider "the best available public 

health infonnation'' 122 The section adds that in setting regulations, the Administrator "shall use 

.. .the best available, peer-reviewed science and supporting studies conducted in accordance with 

sound and objective scientific practices" and in addition "data collected by accepted methods or 

best available methods.··lll When Congress promulgated these statutory requirements in 1996, 

the Senate Committee on Environment and Public Works 124 explained that the "Administrator 

has a duty to seek and rely upon the best available science and information to support. ... [m]any 

116Jd 

117 See 15 U.S.C. ~ 2609(a) ("The Administrator shall ... conduct such research. development. and monitoring as is 

necessary to cmTy out the purposes of this [Act]."); see alw 15 U.S.C. ~ 2609(c). (d). (e). 

"'See !5 U.S.C. ~ 2609(h). (c). (g). 

11 '

1 15 U.S.C. * 2609ib)(2)(A). 100 42 U.S.C. § 300g-l. 12 ' !d. al(b)(I)(A)(i). 122 /d. at(b)(l)(ll)(ii)(fl). 101 42 U.S.C. * 300g-l(bl(3)(A). See City of Waukesha!'. FPA. 320 F.Jd at 247-48 (D.C. Cir. 2003) (holding that 

agency peer review satisfies requirement to use best. peer-reviewed science and supporting studies); City of 

Portland 1'. EPA. 507 F 3d 706. 716 (D.C. Cir. 2002) (same). 12-1 The Report of the Senate Committee on Environment and Public Works is authoritative on these provisions. as 

the language adopted in the Committee bill (S.I316) on the usc of science was adopted verbatim in Pub. L. 104-182. 

SeeS. Rep. 104-169 alp. 121 and Pub. L. 104-!82 at §103. 

3\ 
111 


33371.093

of the most important activities including selecting contaminants for regulation, setting 

standards, designing analytical methods and structuring waivers, variances and exemptions.'>~ 25 

By restricting EPA to considering only those scientific studies for which underlying data, 

models, and other information is publicly available, EPA ·s proposal prevents EPA from 

complying with the SDWA directive that it consider the "best available" public health 

information and science when setting SDW A standards. Specifically, as explained above, the 

public will not necessarily have access to the underlying information used to produce the "best 

available, peer-reviewed science and supporting studies."126 Nowhere does the SOW A authorize 

EPA to ignore such studies based on the public unavailability of underlying information. Thus, 

regardless of the merits of the core objective of EPA's proposal-"to ensure that the regulatory 

science underlying its actions is publicly available in a manner sufficient for independent 

validation'' (proposed§ 30.1 "What is the purpose of this subpart?"). EPA's attempt to elevate 

this objective above the agency's statutory obligation to consider the "best available" science 

when promulgating SDWA standards is unlawfuL 127 

4. EPA's proposed exemption provision does not remedy the unlawfulness of 

prohibiting EPA from considering valid and relevant studies due to the public 

unavailability of underlying data and methods. 

Though the proposed exemption provision in section 30.9 would grant the EPA 

Administrator discretion to authorize the agency to consider studies for which underlying data or 

models are not publicly available, this provision is insufficient to remedy the proposed rule's 

unlawfulness and detrimental impacts. It is well established that existence of a waiver or 

exemption mechanism cannot be used to justify a provision otherwise beyond an agency's legal 

authority. Dimension Financial Corp. v. Board of Governors of Federal Reserve Svslem, 744 

F.2d 1402, 141 0 (I Oth Cir. 1984) ('The possible exception to the initial impact of Regulation Y 

(Part 225.21 (B)(4)) contains requirements with no objective standard and thus unbounded 

agency discretion. This as a device to meet objections to the new regulation cannot cure the 

exercise of powers denied by Congress or not provided for by Congress. Public Uri lilies Comm. 

of Calif v. United Srares, 355 U.S. 534 (1958); In reSurface Jlilining Regulation Litigation, 627 

F.2d 1346 (D.C. Cir. 1980); ALL TEL Corp. v. FCC 838 F.2d 551, 561 (D.C. Cir. 1988) ("The 

FCC cannot save an irrational rule by tacking on a waiver procedure. 'The very essence of 

waiver is the assumed validity of the general rule .... ')(citing WAIT Radio v. FCC, 418 F.2d 

1153. 1158 (D.C. Cir. 1969)); Unired Srares Telecom Ass'n v. FCC. 359 F.3d 554. 571 (D.C. Cir. 

2004) ("Moreover. even if the FCC had adopted some lawful mechanism for making exemptions 

from its general national rule, it could not necessarily rely on the existence of that mechanism as 

the sole justification for not adopting a more narrowly tailored rule .... [T]he mere existence of 

a safety valve does not cure an irrational rule.") 

S. Rep. 104-169 at 28 (emphasis added). 

'" 42 U.S.C. ~ 300g-l(b)(.l)(A). 

'" 83 Fed. Reg. al 18773. 

32 
112 


33371.094

First, while the statutory provisions described above require EPA to consider best 

available science and other relevant information when making regulatory decisions, see, e.g., 

Safe Drinking Water Act, 42 U.S.C Section 300g-1 (b)(3)(A)(i) ("The Administrator shall use the 

best available, peer reviewed science."), the Administrator has discretion over whether to grant 

an exception. See Proposed § 30.9 ("The Administrator may grant an exemption to this subpart 

on a case-by-case basis ... '')(emphasis added). 128 Where a statute requires that the agency 

consider certain information in reaching a decision, EPA cannot promulgate a rule that gives the 

Administrator discretion over whether to allow such consideration. 

Second, the only basis on which the Administrator may grant an exemption under 

Proposed § 30.9 is that it "'is not feasible" to "ensure that all dose response data and models 

underlying pivotal regulatory science is publicly available'' as the rule requires.'" 9 However, the 

Proposal does not explain how ·•feasibility" is to be determined in this context-or even whether 

the term encompasses practical feasibility, cost-effectiveness, or other considerations. Moreover, 

there can easily be situations where it is theoretically ''feasible'' to make underlying data publicly 

available, but this information is nonetheless not publicly available. For example, a scientist who 

intends to rely on the same data to publish multiple papers may be disinclined to make that data 

available to competitorsuo Y ct. because it is technically "feasible" to make the underlying data 

publicly available, the proposed rule would not even provide the Administrator with authority to 

grant an exemption authorizing such consideration, thus forcing the Administrator to violate the 

law. 

Third, even if it were lawful for EPA to ignore relevant science, the exemption provision 

is arbitrary, as it does not define sufficient criteria or process steps by which the Administrator 

may decide to exempt a study. The provision instructs the Administrator to rely on a handful of 

broad (and highly manipulable) policy considerations in determining whether it would be 

infeasible to make data and methods publicly available. 131 These factors could be applied broadly 

to give the Administrator nearly absolute discretion. From the face of the Proposal, it is not even 

clear that the Administrator would be required to provide a public, written explanation of his 

decision to grant (or deny) a waiver. This lack of accountability could lead to the arbitrary 

exclusion of sllldies the Administrator unilaterally cbooscs to not exempt. 

"~ 83 Fed. Reg. at 18774. 129 83 Fed. Reg. at 18774. 1

'

0 Or in cases \vhere companies jointly funded research it may he unclear who owns the data and has the right to 

share it, and companies may be reluctant to share it V•lith competitors. See, e.g, National Academies of Sciences. 

Engineering, and Medicine. Principles and obstacles for sharing data from environmental health research: 

Workshop SUI11111WJ'. 45 The National Academies Press (2016). https://www.nap.edu/catalog/217031principles-andobstaclcs-t0r-sharing~data-ti·om~environmental-health-research. ("As you can imagine. . not all competitors play 

nicely together. Some even resort to gamesmanship to try to exclude competitors from the market. Things can get 

nasty and messy in a hurry in these discussions."). 131 See 83 Pcd. Reg. at 18774. Under R30.9(a). the Administrator should consider whether it is infeasible "in a 

fashion that is consistent with la\v. protects privacy. confidentiality, confidential business information. and is 

sensitive to national and homeland security." ~30.9(b) references 70 Fed. Reg. :1:664. which exempts peer review in 

situations of''disscminations of sensitive information related to ce11ain national security, foreign affairs. or 

negotiations involving international treaties and trade \Vhere compliance with this Bulletin would interfere with the 

need for secrecy or promptness:· 

33 
113 


33371.095

Finally, the exemption provision is impractical and likely could not be implemented 

effectively. According to the Congressional Budget Office, EPA "relies on about 50,000 

scientific studies annually to perform its mission.'' and at times, relies on thousands of studies for 

one action. 132 Many of the studies that would he affected by this rule are complex and include 

large datasets that would lead to an extensive decision-making process under the exemption 

provision. EPA does not include any rationale in the proposal justifying how the Administrator 

could reasonably decide to exempt studies on a case-by-case basis given the tens of thousands of 

studies EPA considers each year. This provision could create a large backlog, which would result 

in important studies being effectively removed from EPA consideration because of the need to 

finalize a regulation before an exemption for every relevant study is granted. Accordingly, the 

exemption provision fails to safeguard against the unlawful exclusion of valid science from 

EPA's regulatory process. 

C. EPA's Proposed Rule Would Violate the Information Quality Act. 

EPA's proposed rule is also unlawful because it exceeds EPA's authority under Section 

515(a) of the Treasury and General Government Appropriations Act for Fiscal Year 200 I (Public 

Law 16-554; H.R. 5658), commonly referred to as the Information Quality Act. 133 Specifically, 

the Information Quality Act requires EPA promulgate data quality guidelines that arc consistent 

with those promulgated by the Office of Management and Budget. Contrary to EPA's assertion 

in the preamble to the proposal, the Proposed Rule is not consistent with OMB's data quality 

regulations. 

The OMB Guidelines recognize that data availability is not necessary to high quality 

science, but is one among many factors. While imposing high standards of quality. objectivity, 

utility, and integrity of information disseminated by Federal Agencies, the Guidelines recognize 

the need to implement controls "flexibly. and in a manner appropriate to the nature ... of the 

information to be disscminatcd." 134 As part of ensuring ''objectivity" these guidelines encourage 

agencies that disseminate influential scientific. financial, or statistical information, "to include a 

high degree of transparency about data and methods to facilitate the reproducibility of such 

information by quali1ied third parties." 135 However, they emphasize the need to treat certain data 

differently, due to privacy and confidentiality conccrns. 136 In fact, the OMB Regulations 

specifically declare that ''[wlith regard to original and supporting data related thereto, agency 

guidelines shall not require that all disseminared data be subjected to a reproducibility 

requirement.'' 137 Rather, the OMB Guidelines instruct that agencies "identify. in consultation 

with the relevant scientific and technical communities, those pa11icular types of data that can 

132 Congressional Budget Oftice, Cost &timate.· fl R !DO 2-3 (March 29. 2017). 

https:/ /www.cbo.gov/svstem/lilesll 15th-congress-20 17-20 18/costestimate/hr I 43 O.pdC 133 Codilied at 44 U.S.C. 3504(d)(l) and 3516. 

!H OMB"s Guidelines Ensuring and Maximi::ing the Quality, Objectivity, Utility. and Integrity r~fbtformation. 67 

Fed. Reg. 8.452. 8.453 (Feb. 22. 2002). 

'"67 Fed. Reg. at 8460. 131' Q;\/B ·s Guidelines Ensuring and Maximi:ing the Quality, Objectivity. Utility. and !megrity <~[information, 67 

Fed. Reg. 8. 452. 8.460 (Feb. 22, 2002) (interest in making data publicly available "does not override other 

compelling interests such as privacy. trade secrets. intellectual property. and other confidentiality protections"). 

67 Fed. Reg. at 8460 (emphasis added). 

34 
114 


33371.096

practicable [sic] be subjected to a reproducibility requirement, given ethical, feasibility. or 

confidentiality constraints." 138 The OMB Regulations ti.1rther explain that while ''[m]aking the 

data and methods publicly available will assist in determining whether analytic results are 

reproducible .. .the objectivity standard does not override other compelling interests such as 

privacy, trade secrets, intellectual property, and other confidentiality protections. 139 OMB 

explains that "where public access to data and methods will not occur due to other compelling 

interests, agencies shall apply especially rigorous robustness checks to analytic results and 

document what checks were undertaken." 140 

By outright prohibiting EPA from relying on a study to support a significant rulcmaking 

if that study's underlying data and models are not publicly available, EPA's proposed rule 

departs from OMB's unambiguous language instructing agencies that they ''shall not'' require 

that all data and models be subject to the reproducibility requirement, and that "the objectivity 

standard does not override other compelling interests." 141 The fact that EPA's proposed rule 

includes a discretionary "exemption" provision does not correct this problem, as that provision 

would not require the Administrator even to consider whether an exemption is warranted, let 

alone grant such an exemption under appropriate circumstances. 

Because Congress expressly granted OMB the authority to set guidelines for data quality 

and instructed agencies like EPA to follow OMS's lead, EPA lacks statutory authority to adopt a 

regulation that is contrary to OMS's guidelines. Accordingly, EPA's proposed regulation 

violates the Information Quality Act and must be withdrawn. " 2 

II. EPA's Proposed Rule is Unreasonable and Arbitral)' and Capricious. 

In addition to violating the requirements of the various statutes that EPA administers or is 

subject to, the Proposal suffers from a total failure to consider important dimensions of the 

profound shift in policy that it implements. In the Proposal, EPA neglects to consider the many 

legitimate reasons why a study's underlying data may not be publicly available-reasons that 

have nothing to do with the quality of the study-and fails to offer solutions consistent with 

these legitimate limitations. EPA makes vague gestures to various guidelines and practices 

issued by other agencies and scientific organizations, none of which actually support the 

Proposal's radical position that EPA should exclude consideration of studies that rely upon 

confidential data. EPA does not even establish that there is a real problem that the Proposal 

would actually address: nowhere in the Proposal does EPA identify any prior agency action that 

has been called into serious question due to a failure to release study data. EPA's utter failure 

"to consider an important aspect of the problem" and to provide an explanation for the Proposal 

138 67 Fed. Reg. at R460. There is no indication that EPA consulted with the .scientific and technical community--or 

even its own Science Advisory Board-before proposing to require that the underlying data and models be made 

publicly available tbr all pivotal regulatory science regardless of ethicaL feasibility. or confidentiality constraints. 1

"' 67 Fed. Reg. at 8460 (emphasis added). 110 67 Fed. Reg. at 8460. 141 See 67 Fed. Reg. at 8460. 

'"Prime Time !nt'l Co. l'. fli!sack, 599 FJd 678.685 (D.C. Cir. 2010) ("[l3]ecause Congress delegated to OMfl 

authority to develop binding guidelines implementing the IQA. we defer to OMB's reasonable construction of the 

swtute.") 

35 
115 


33371.097

that is consistent with the evidence before the agency renders the Proposal wholly arbitrary and 

capricious. See Adotor Vehicle Mfrs. Ass 'n. v. Slate Farm Mut. Auto. ins. Co., 463 U.S. 29, 43 

( 1983). Likewise, EPA's failure to explain its 180-degree change in position from its former 

belief that the lack of publicly-available data does not render a study inappropriate tor 

consideration in regulating is a hallmark of arbitrary and capricious decision-making. FCC v. 

Fox Telev. Stalions, inc., 556 U.S. 502, 515-16 (2009). 

A. EPA Failed to Consider the Legitimate Reasons That Underlying Data May 

Not be Made Publicly Available, or to Propose Solutions to Remedy These Actual 

Limitations. 

I. There are multiple reasons why underlying data are not publiclv available 

for all studies. 

There are legal and ethical requirements that restrict making public the data underlying 

studies, including rules to shield private personal information, requirements to maintain 

confidential business information, situations where obtaining the necessary permissions to 

release data are logistically difficult or impossible, and situations in which researchers have 

made significant investments in developing datasets that they intend to continue to work with for 

future studies. Not all of these barriers can be overcome, nor can they be overcome in every case. 

While there are ways potentially to address some of them, they can be extremely costly and 

burdensome, and/or may harm the prospects for further research. Accordingly, while the 

scientific community has made efforts to make more data publicly available, to the best of our 

knowledge all of the policies adopted by government and academic journals recognize that data 

is not, and need not be, publicly available to evaluate their quality. 

a) Strong legal and ethical requirements limit the release of data in 

human subjects studies. 

Particularly with respect to human subjects, there are strong legal and ethical privacy and 

confidentiality protections, which researchers are bound to respect. 143 In some cases, researchers 

would be subject to civil or criminal penalties for violationsi 44 

The environmental health dose response studies targeted by EPA's proposal are likely to 

include human population studies (or epidemiological studies). Often the best available 

epidemiological studies contain extensive and sensitive data on individuals, such as 

environmental exposures, medical history (such as infant reproductive developmental 

abnormalities, children's behavioral and development problems, heart attacks or dementia among 

the elderly). dates of birth. residential address, drug use. race, socio-economic status (income, 

l·P See. e.g. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral 

Research. The Belmont Report (Apr. 18. 1979). https://www.hhs.gov/ohrp/sites/default/!ilcs/the-belmont-report508c FINAL.pdf: Federal Policyjrll' the Protection of !inman Subjects. Final Rule. 82 Fed. Reg. 7.149 (Jan. 19, 

2017): HIPAA Privacy Rule. 45 C.F.R. §§ 160. 164.102-06. 164.500-534. 

'"See, The Health Insurance Portability and Accountability Act of 1996 (IIIPAA). Public Law 104-191 (enacted 

Aug. 21, 1996) (providing f{x criminal and civil penalties fOr violations). 

36 
116 


33371.098

education), status of subjects' marriages, employment history, etc. For example, air pollution 

studies commonly use residential address information to assign air pollution exposures and link 

them to health cffects. 145 Other studies focused on genetically susceptible populations may also 

be linked to genetic databases or contain information on key genetic mutations that are strongly 

predictive of serious health risks, such as risk of Alzheimer's disease, and are thus very 

sensitive. 146 

To conduct these studies, investigators must obtain informed consent from the study 

participants to collect protected health information, and investigators must sign documents 

promising to protect the privacy of this individually identifiable health information. Absent 

complex, difficult and costly de-identification and redaction techniques, these data simply cannot 

be released publicly. As discussed below in section li.A.2.b), in some cases such techniques are 

simply not applicable or still leave significant risk of breach of privacy. 

Additional protections apply to specific types of human subject information. For 

example, medical records are subject to strict requirements governing the use and disclosure of 

such information under the Health Insurance Portability and Accountability Act of 1996 

(H IPAA). 147 HIPAA requires researchers to protect identifiable information, and it provides that 

such information may only be disclosed for research purposes with the written consent of the 

person providing the information. 148 

Another limitation on public availability of data is the requirement under the Federal 

Policy lor the Protection of Human Subjects (also known as the Common Rule) that for all 

federally funded studies involving human research subjects, researchers must first obtain 

Institutional Review Board (IRB) approval and informed consent from study participants. 149 

An IRB reviews each human subjects research project to ensure that the specific research 

protocol protects individual rights. Participants must be notified about the degree to which the 

confidentiality of their records will be maintained, and must receive appropriate notification and 

145 See, e.g.. Kaufman. Joel D .. et al.~ Assodation henreen air pollution and coronmy ariel)! calcification within six 

metropolitan areas in the USA (the t\tulti-Ethnic ~)~rudy (?[Atherosclerosis and .-1ir Pollution): a longitudinal cohort 

stur(v. 388.10045 The Lancet 696-704 (2016). 

'"'See. e.g, Richardson JR. Roy/\, Shalat SL. von Stein RT. Hossain MM. Buckley B. Gearing M. Levey AI. 

German OC. Elevated serum pesticide levels and risk for Af=heimer disease. 71(3) Jt\MA Neurology 284-90 (Mar. 

I. 2014). 147 PublicLawl04 191. 

!-1S National Reser:~rch Council, Expanding Access to Research Data: Reconciling Risks and Opportunities. The 

National Academies Press (2005). 

"'' 45 C.P.R. ~R 46. I 01-124 is the U.S. Department of Health and Human Services ("HHS") citation ror the 

Common Rule. t\ total of 18 federal agencies have adopted it: each agency has its own separate entry in the Code of 

Federal Regulations. This federal rule governs ethical constraints that federally fttnded studies must follow, 

including academic research, responding to earlier concerns of ethical lapses in medical research. See, e.g.. Jerry 

MenikotT. Could Tuskegee happen Today'. I St. Louis U. J. Health L. & Pol'y 311. 3 12-16 (2008) (describing the 

Congressional response to public outcry when the details or the Tuskegee experiment were brought to light). The 

thrust of the Common Rule is to address such matters of research ethics as inl(wmcd consent. informational risk. and 

institutional oversight when research invoh·es human subjects. 

37 
117 


33371.099

give consent if study data is to be shared outside the research team. 150 The IRB also considers 

risks to the participants and how use of the information obtained may adversely impact the rights 

and welfare of the subjects. 151 Most institutions have committed to comply with the Common 

Rule for all of their research, even when it is not federally-funded. 152 

For studies that had received IRB approval prior to finalization of this proposed rule, 

there may be no practical opportunity to make the data publicly available. Even for new studies 

going forward, it may be extremely difficult, require additional (often unavailable) funding for 

elaborate protective measures, or simply impossible to obtain IRB approval for protocols that 

would allow the data to be made publicly available. 

EPA's own Science Advisory Board voiced these concerns that EPA was discounting the 

challenges to making even limited releases of data, saying: 

The proposed rule oversimplifies the argument that ··concerns about access to 

confidential or private information can, in many case, be addressed through the 

application of solutions commonly in use across some parts of the Federal government." 

For studies already completed or underway, the participation of human subjects is 

undertaken according to terms approved by the cognizant IRB. These terms can vary 

from study to study. ln some cases, the data cannot be released simply by redacting 

portions of it. For example, data may have been collected with an assurance to the 

participating individuals that their data would be kept confidential. 153 

Some researchers might respond by choosing to work only on public administrative 

datascts, but this would harm rather than strengthen science quality by curtailing scientific 

inquiry. Thus, the effects of EPA's proposed approach would cause some researchers to choose 

not to pursue research with human subjects, stifling scientific discovery, while others would 

forgo compliance with EPA's regulatory requirements and have their research ignored by EPA. 

As a result, EPA's proposal would both discourage the development of best available science as 

well as EPA's use of it. 

b) There are especially significant barriers to public release of 

underlying data and models from studies that have already been 

completed. 

With respect to studies that have already been completed, there are additional formidable 

barriers to public release of underlying data and models. Particularly. with older studies, simply 

finding the data sets and determining ownership may be expensive or impossible. For older 

studies with human subjects. obtaining consent to release of data may be practically impossible, 

150 See. 82 Fed. Reg. 7.149-7,274. 

151 /d. 

152 HilS. Federahvide Assurance (FWA)for the Protection of Human Subjects, https://www.hhs.gov/ohro/registcrirbs-and-obtain-t\vas/l\vas/fwa-projection-ot~human-subjecct/index.html (last accessed Aug. 13, 20 18). 153 ;v!emorandum by Alison Cullen. Chair, SAB Work Group on EPA Planned Actions tor SAB Consideration orthe 

Underlying Science (May 12. 2018). 

38 
118 


33371.100

and the data may have been collected in ways that would make protecting privacy with release 

difficult or impossible. 154 

For some studies. administrative issues related to the data could be the most difficult 

barrier to overcome in providing for public release. Larger and more costly studies are often 

performed by groups of researchers within a university, across multiple institutions, or across 

multiple individual companies. Over time, the data itself may become lost or misplaced, or it 

may become unclear who actually owns and controls access to the data. Academics move among 

institutions, companies merge and spin oft: and the initial agreements were not always clear in 

the first instance. Obtaining consent from multiple institutional players takes extensive time and 

resources, at minimum. and simply may no longer be possible in some instances. 155 

These problems are exacerbated with respect to human subject studies. Researchers are 

legally and ethically obliged either to protect the privacy of the individual study subjects or attain 

each subject's consent to share data. 156 This can be impractical for older studies and virtually 

impossible for larger studies, and extremely burdensome. For example, the Harvard Six cities 

study was started in 1975 and had 8,111 participants. 157 The ACS CPS II extended analysis by 

Krewski in 2009, which is central to PM2 s NAAQS standards, was initiated in 1979 and 

encompassed data from 500.000 study pmiicipants who lived in I 16 metropolitan arcas. 15 s For 

these types of situations, tracking down participants (or where the participants have passed away. 

their family members) to get consent is simply not realistically possible. 

Even in situations where investigators might theoretically be able to attain consent, it 

would require extensive financial and human resources, which are usually simply not available. 

especially to academic researchers or to EPA. EPA ignores this prohibitive constraint and makes 

no attempt to address it. 

c) There are additional significant barriers to public release of data in 

some situations, even for prospective studies. 

Even with respect to prospective application of EPA's proposal. providing for public 

release of underlying data and models is costly and resource intensive, creating a serious 

disincentive for researchers to meet EPA's proposed requirements. Investigators willing to make 

their study underlying data publicly available would still face the logistical hurdle of making the 

data and models available in a manner sufticient for independent validation by the public. In 

154 See, e.g., National Academics of Sciences. Engineering. and Medicine. Principles and obstacles for sharing da!a 

frorn environmental health research: FVorkshop surnmm:v. 61-63 The National Academies Press (20 I6). 

https :! /www .nap .cdu/ cata I og/2 1 703 /principl es~and~o bstacles~for-sharin g-data-from-env ironmenta I ~heal th-rcsearch. 

'" ld at45. 156 Federal Policy for the Protection of Human Subjects; Final Rule. 82 Fed. Reg. 7,149 (Jan. 19. 2017): HIPAA 

Privacy Rule. 45 C.F.R. §§ 160. 164.102-106. 164.500-534. 157 Dockery. D.W .. Pope. C.A .. Xu. X .. Spengler. J.D .. Ware . .I.H .. Fay, M.E., Ferris Jr. B.G. and Speizer. F.E .. An 

association between air pollution and mortality in six US cities, 329(24) New England Journal of Medicine. 1753-

1759 (1993). 

lSS Krew-ski D, Jen·ett M, Burnett RT. ct aL. £r.tended Follow-Up and Spatial Ana~vsis (~fthe American Cancer 

Society Swdy Linking Particulate Air Pollution and Mortality. 140 Health Effects Institute, Boston MA (2009). 

39 
119 


33371.101

addition to the cost of thoughtful and effective deidentification or redaction of sensitive 

information, the proposed text would likely require researchers to prepare annotated manuals 

including precise detail as to what variables were collected. how information was collected, and 

the rationale for each step taken. Some manuals alone run into hundreds of pages. One press 

account noted the example of publicly available datasets from the National Center for Health 

Statistics, which can come with I 00-page manuals; researchers would need to hire additional 

staff to meet such requirements. 159 Yet EPA fails even to recognize (much less propose any 

means to address) the cost to researchers in time and money, on top of the constraints on 

academic research already imposed by the very limited funding available for this type of work. 

In addition, there are other barriers to public release of underlying data. Studies 

conducted on behalf of industry or with industry cooperation may contain confidential business 

information, the release of which could jeopardize a company's competitiveness. 

Also, in some instances, researchers cannot make their data sets public without losing 

much of the value to the researcher of these laboriously and meticulously collected sets of 

information. Research, especially those studies that include large numbers of human subjects. are 

incredibly human and capital intensive endeavors. Moreover researchers may base years of work 

and multiple papers on unique datasets they developed and hold, and many scientists build their 

careers on carefully harvesting information from single large studies for years to come. It is not 

only unreasonable, but also unfair, to expect academic scientists to turn over their intellectual 

property and research investments, forgoing potential earnings and career advancements. 

Moreover, EPA's myopic and inflexible approach to data access gives no consideration to data 

sharing arrangements between researchers and the agency that could be developed to support 

EPA's consideration and integration of research. 

If scientists arc forced to choose between giving away their hard-earned data or forgoing 

any regulatory impact. it will discourage scientists from engaging in critical science that is 

targeted to help prevent disease and disability in our population. It appears that in many cases, 

scientists will choose to retain their datasets, with a worst-of-both-worlds result-EPA will be 

deprived of valid scientific information and the scientific community will be discouraged from 

contributing their critical expertise to policy-making. EPA's Proposal does not consider the realworld implications of forcing such choices on researchers. 

The agency's failure to consider or examine any of these legitimate reasons for not 

making data publicly available is arbitrary and capricious. 

2. The Proposal fails to propose any actual solutions to remedy the legitimate 

reasons tor why data may not be made publicly available. 

In the proposal EPA blithely and irrationally ignores or assumes away the real and 

significant issues raised above. suggesting that existing mechanisms and techniques can be used 

150 Alessandra Potenza and Rachel Becker. Sco!l Pruilt 's mnr 'secret science' proposal is the wrong way to increase 

transparency Here ·s what scienfist.s think a science transparency rule should include. The Verge (May 1. 20 18~ 

g :30am EDT). https://www.thcvcr£c.com/20 18/5/ I I 173 04298/cpa-science-transrurencv-ru le-scott-pruitt-datasharing. 

40 
120 


33371.102

to protect privacy and confidentiality while making underlying research data publicly available. 

In fact, the evidence (including several of the sources that EPA cites) indicates that the potential 

mechanisms alluded to by EPA would only have the potential to address some of the barriers 

cited above, have serious limitations even for those, and are actllally becoming less effective as it 

becomes easier to combine and manipulate public data sets. 

a) EPA vaguely references a range of possible approaches to 

protecting privacy and confidentiality, but provides no evidence that any 

of these are sufficient to address the legitimate concerns raised above. 

EPA vaguely claims "'concerns about access to confidential or private information can, in 

many cases, be addressed through the application of solutions commonly in use across some 

parts of the Federal government."' 160 EPA claims that there are examples from the Department of 

Health and Human Services, the National Institute of Standards and Technology, the Department 

of Education, and the Census Bureau. Unfortunately, apart from a reference to HHS guidance on 

data de-identification (discussed below), EPA does not actually identify or cite to any specific 

examples from these agencies in the proposed rule itself: making it impossible to discern what 

examples EPA believes exist or to meaningfully comment upon the degree to which such 

examples, if they exist, might suggest that these issues are manageable. The additional 

hyperlinks added to the docket on May 25, 2018, weeks into the comment period, also link to 

examples that provide no further assurance that this proposal can be implemented without 

implicating privacy concerns, and as discussed in detail below, the vaguely referenced other 

agencies' "solutions" are unlikely to be of much help. 

The "solutions'' EPA might have in mind do not address the issues raised by the Proposal 

because no other agency has tried to implement a requirement such as the one EPA proposes. 

Other agencies provide guidance and techniques to protect privacy during data collection and 

disclosure to allow more use of data collected by the government, not to mandate that data 

collected by academic or industry researchers be publicly available for purposes of replicating 

analyses. The Department of Education. for example, has shared techniques for institutions to 

provide data on students and schools to meet reporting requirements without compromising 

privacy. 161 They recognize that each technique "requires some loss ofinfonnation.'" 62 While deidentified information may still be useful, e.g .. to show overall school progress, in the context of 

the Education Department, it is not clear these techniques arc transferable to other contexts. 

EPA links to a document of the Privacy Technical Assistance Center, Data Deidentification: An Overview of Basic Terms, which provides a high-level overview of key terms 

and practices to help educational agencies and institutions comply with the Family Educational 

Rights and Privacy Act (FERPA). 163 This document is concerned witb data disclosure that occurs 

160 83 Fed. Reg. 18.770. 161 National Center tOr Education Statistics. SLDS Technical Brief· Statistical Aiethodsfor PrOTecting Personally 

Identifiable lnj(>rmation in Aggregate Reporting (Dec. 20 I 0). https:l/nccs.cd.govlpubs20 lll2011603.pdf. 

()~ ld at27. 161 Privacy Technical Assistnncc Center. Data De-identification: An Overview of Basic Terms (200 I). 

https://studentprivacy.ecl.gov/sites/defau!Ufiles!resourccdocument/filc/datadeidentiticationterms.pd[ 

41 
121 


33371.103

"when schools, districts, or states publish reports on student achievement or share students' data 

with external researchers" not to make underlying data publicly available for independent 

validation. 164 Thus, it is unclear that methods used to de-identify but preserve data for those 

purposes would be adequate in this context. For example, one of the methods that the U.S. 

Department of Education uses for disclosure avoidance for tabular data is to not release 

information for any cell that has a size below some minimum, which essentially means not 

disclosing information where there are small numbers in a certain cell. 165 Thus, it is quite 

possible that techniques that result in a loss of information would prevent researchers !rom 

repeating the experiment. Yet EPA fails to acknowledge the nuances and limitations of these 

policies. 

EPA links to a NIST document entitled De-Identification of Personal Information by 

Simson L. Garfinkel (NISTIR 8053), which discusses de-identification, but not in the context of 

making research data publicly available for independently validating scientific studies. The 

document instead notes that ''that there is a trade-off between the amount of de-identification and 

the utility of the resulting data" and that ''[i]t is thus the role of the data controller, standards 

bodies, regulators. lawmakers and courts to determine the appropriate level of security, and 

thereby the acceptable trade-off between de-identification and utility." 166 It further notes that 

"de-identification approaches based on suppressing or generalizing specific fields in a database 

cannot provide absolute privacy guarantees, because there is always a chance that the remaining 

data can be re-identified using an auxiliary dataset." 167 

EPA's reference to the U.S. Census Bureau is similarly unhelpful. !Jere EPA provides a 

link to a website titled Data Ingest and Linkage that details the U.S. Census Bureau's approach to 

linking data across many records they hold. 168 The Website links to a working paper that describes 

the method by which the Census assigns a unique person identifier to records it holds that 

enables it to link records together to create the tina! file. 169 It is totally unclear how this process 

on linking together records is a solution that EPA could implement to protect privacy of 

individuals when disclosing data as it concerns how to identify data with specific people-not 

protecting privacy. 

While other agencies are clearly grappling with the issue of how to make governmentcollected data available. they have also highlighted the many challenges in protecting privacy 

and confidentiality while doing so-such as the ability for de-identified data to be re-identifiedand these agencies accept that there is more work to be done before these concerns are fully 

:u-t !d. at I. 

)(' 5 !d. at 4. 

166 Simson L.. Garfinkel. De-Identification of'Personal In/ormation (NISTIR 8053). 11-12 NIST (Oct. 2015). 

https:l/nvlpubs.nist.gov/nistpubslir/20 !SiN! ST.! R.8053 .pdf. 

"'

7 ld al5. 168 U.S. Census Bureau, Data Ingest and Linkage. https://\vww .census.gov/about/adnn/linkage/technicaldocumcntation/processing-de-identiHcation.html (last accessed Aug. 13. 20 15). 160 Deborah \Vagner & Mary Layne. The Person !dem{/7cation Validation System (PVS}· App~ving the Center for 

Administrath·e Record~· Research and Applications· (C'ARRAJ Record Linkage Soft1l'are. CARRA \Vorking Paper 

Series. Working Paper# 2014-0 I. U.S. Census Bureau (July I. 2014 ). 

42 
122 


33371.104

addressed. 170 The letter filed in this docket by the Presidents of the National Academies of 

Science, Engineering and Medicine underscores these difficulties, specifically noting the 

National Academies' previous work finding that "statistical analyses of data sets that generate 

highly precise results-such as geographic specificity or other characteristics that identify 

respondents-may result in privacy breaches ... This presents a new challenge that federal 

statistical agencies are just beginning to address." 171 EPA docs not even acknowledge, much less 

try to address, these gaps in agencies' abilities to protect sensitive data. 

EPA cursorily mentions a range of options for facilitating secure access to confidential 

data, including: "[r)equiring applications for access; restricting access to data for the purposes of 

replication, validation, and sensitivity evaluation; establishing physical controls on data storage; 

online training for researchers; and nondisclosure agrecments." 172 EPA docs not indicate whether 

it would deem providing access with these types of controls in place sufficient to meet EPA's 

proposed requirement "publicly available in a manner sufficient for independent validation.'' 

EPA also fails to recognize the significant costs associated with implementing most of these 

options or the risks to privacy that remain even if these methods are employed. 

b) EPA cites to one example-the technique of deidentification-but 

fails to acknowledge, let alone address, the significant costs and 

limitations of this approach. 

As already discussed, it is legally and ethically necessary to ensure the privacy of the 

individuals whose data have been collected, as some of these data, such as medical history or 

employment data, can be quite sensitive. EPA suggests deidentification and redaction of 

sensitive information can be used to protect privacy when study data is made public. EPA fails to 

recognize that these techniques are generally burdensome and costly, and may lose too much 

information for replication purposes. EPA also ignores the real concerns. based in empirical 

evidence, about reidentification of individuals through cross linking with existing public datasets 

and the ensuing breach of privacy. 173 

170 See. e.g., Simson L. Garfinkel. De-Identification qf Personal Information (NISTIR 8053), NIST (Oct. 2015) 

(detailing methods ofre-identification and challenges to de-identifying information. concluding "there is 

comparatively little known about the underlying science of de-identitkation" and "there is a clear need for standards 

and assessment techniques that can measurably address the breadth of data and risks described in this paper."). 171 Letter to Acting Administrator Wheeler fh)m Marcia McNutt, President of the National Academy of Sciences, 

C. D. Mote, Jr., President of the National Academy of Engineering. and Victor J. Dzau. President ofthc National 

Academy of Medicine at 4 (July 16. 2018) (citations removed). 170 83 fed. Reg. 18.771. 

"Recently. a peer reviewed study examined the identifiability of records t1·om an environmental health study in 

Northern Ca!it(xnia. Using data considered by HIPAA to be sufficiently de-identified to be made public. \vhich 

involved tar fe\ver variables than \vou!d be required to make public in the cohort studies. they \Vere able to correctly 

identil'y over 25%. of the participants. Another study searched the Lcxis-Nexis database for stories that mentioned 

hospitalization. and by matching that v.:ith age. race. sex and Zip code ti·om a supposedly anonymized hospital 

admissions data base was able to match 43% of the people named in the news stories to their medical records ... 

Comments of the International Society f{w Environmental Epidemiology on EPA ·s proposed rule on Strengthening 

Transparency in Regulatory Science (EPA-HQ-OA2018-0259-000 11 

https:llwww.regulations.gov/documcnt'!D~EPA-HQ-OA-2018-0259-1973 (citing Sweeney L. Yoo JS. l'ero,ich L 

Boronow KE. Brown P and .IG B .. Re-ident[fication Risks in HIPAA 5;qfe Harhor Data: A s/Udy of data from one 

43 
123 


33371.105

Indeed, experts have observed that even the disclosure of redacted or "de-identilied" data 

sets has become more fraught as public health studies have become more rigorous, because these 

studies are relying upon greater quantities of ever more granular personal information. 174 

i. De identification is complicated and costly. 

EPA states that "[o]ther federal agencies have developed tools and methods to deidentify 

private information." but then cites to only one source, which does not address the concerns 

raised here. 175 EPA cites to the U.S. Department of Health and Human Services' Guidance 

Regarding Methods for De-identification of Protected Health Information in Accordance with 

the Health Insurance Portability and Accountability Act (HJPAA) Privacy Rule. 176 This guidance 

provides two methods for de-identifying data: (I) expert determination method, where an expert 

determines that, after application of statistical and scientilic principals and methods, the risk is 

very small that the information alone or with other available information could be used to 

identify the subject; and (2) the safe harbor method, requiring that a number of identiliers are 

removed. 177 The first method requires case-by-case work, and EPA has provided no information 

regarding how EPA or others could potentially implement it or how much it might cost. In 

addition, there is no indication of how broadly this technique might be applicable to adequately 

de-identify data. I.e., EPA must provide its views on whether this technique is likely to be 

applicable to the majority of studies relevant to EPA with non-public data, some studies, or only 

a handful. The second method requires removal of much information that may be necessary to be 

able to reanalyze or reproduce the research results. so it is unclear whether it would satisfy 

EPA's requirements in the Proposal. The second method is also costly, which EPA also 

completely disregards. Furthermore, even the safe harbor method has been shown to provide 

potentially insufficient privacy protections due to the mosaic effect. discussed more below. 

EPA fu11her states: "The National Academies have noted that simple data masking. 

coding, and de-identilication techniques have been developed over the last half century ... , '' 

seemingly suggesting that data can easily be modified to address privacy concerns. 178 This is 

incorrect. The National Academies in fact recognizes that complex, evolving, and yet 

undeveloped techniques are needed to resolve these concerns: "Initially. relatively simple data 

masking techniques, such as top coding income amounts ... were used to generate restricted data 

em'ironmentaf health study. Technology Science (2017) and Sweeney L,, Only } 'ou, }'our Doctor, and ~'4any Others 

Jfay Know. Technology Science (2015)). 

'"See Letter tt·om DanielS. Greenbaum. llealth Effects Institute. to Lck Kadeli. Environmental Protection Agency 

3 (Aug. 27. 2013) (describing the usc ofincreasingly tine-grained community-level and zip code-level data in public 

health studies. and noting that ''these characteristics which have in general enhanced the quality and the sensitivity 

of the studies- increase the difficulty of providing a fully "de-identified" data set while also enabling a different 

investigator to conduct a full replication and sensitivity analysis or the original stud; r~sults:·). 

83 Fed. Reg. at 18.771. 

83 Fed. Reg. at 18.771 n. 17. 

HHS. Guidance Regarding i\lethodsfor De-ident{/lcation of Protected Health iJ?formathm in .-lccordance 'rith 

the Health Insurance Portobili(v and ,Jccountability Act (H/PAA) Privac.v Rule. https://www.hhs.gov/hipaa/forrro ressionalslpri vacv /special-topics/ d e-idcnti lication/i ndex. h tml 

'" 83 Fed. Reg. at 18.771. 

44 
124 


33371.106

products [,] [ d]uring the last decade the increasing risks of confidentiality breaches have led 

researchers to develop increasingly sophisticated methodologies for restricted data products." 17" 

They state, ''more research is clearly needed to assess the relative ability of different masking 

methods, and of synthetic data. to reduce the risk of disclosure while preserving data utility." 180 

They recognize the current limitations of producing restricted data that sufficiently limits 

identifiability to allow it to be made publicly available in a useful torm. They note that "wellinformed policy making" requires "[r]csearch using detailed confidential data'' that cannot be 

made public-which the Proposal fails to acknowledge to the detriment of the quality of EPA's 

policy dccisions 181 In the meantime, the National Academies state that more work is needed to 

allow "[h]igh-quality public-use files'' that still assure ''the inferential validity of the data while 

safeguarding their confidentiality." 182 

ii. Ongoing developments in data analytics make data 

de identification more difficult to conduct and less /ikefv to 

adequately protect privacy and confidentiality. 

In pointing to the option of deidentification and redaction techniques, EPA also fails even 

to mention, let alone address, the increasing risk of re-identification through data analysis using 

multiple data sets. The so-called "mosaic effect" makes even very limited, redacted releases of 

data to the public a threat to the privacy of study subjects. OMB has recognized the threat to 

privacy from the mosaic effect. which it describes as "when the information in an individual 

dataset, in isolation, may not pose a risk of identifying an individual (or threatening some other 

important interest such as security), but when combined with other available information, could 

pose such risk.''m OMI3 specifically highlighted the complicated nature of this threat and the 

need for agencies to address it carefully, particularly as they may not possess the needed 

expertise. 184 

Studies show the reality and scope of there-identification threat. For example, Dr. 

Latanya Sweeney, professor of government and technology in residence at Harvard University, 

has examined dcidcntified datasets and combined them with other public data sets to test this 

concern. She was able to use information in medical information and a voter list, such as birth 

date, gender, and zip code, to identify individuals in the deidentified Massachusetts Group 

Health Insurance Commission dataset in 1997, including the then Massachusetts Governor, 

179 National Research CounciL f"'.xpanding Access to Re:warch Data· Reconciling Risks and Opportunities~ 27 The 

National Academies Press (2005 ). 180 ld at 28. 

'"ld at 2. ISO /d 

183 OMIJ Memorandum M-13-13, Memorandum f(Jr the Heads of Executive Departments and Agencies on Open 

Data Policy-Managing lnt(wmation as an Asset 4-5 (May 9, 2013). 18;

1 !d at 9-10 (''Agencies should note that the mosaic effect demands a risk-based analysis. often utilizing statistical 

methods whose parameters can change over time. depending on the nature of the information. the availability of 

other information. and the technology in place that could facilitate the process of identification. Because of the 

complexity of this analysis and the scope of data involved. agencies nHlY choose to take advantage of entities in the 

r::xecutive Bran12h that rna; have relevant expertise. including the staff' of Data.gov. ") 

45 
125 


33371.107

William Weld. 185 Studies have indicated that between 63% and 87% of the population of the 

United States could be uniquely identified by using only gender, ZIP code, and date ofbirth. 186 

Dr. Sweeney was also able to link data in the Personal Genome Project to names and contact 

information, identifying between 84 to 97% of profiles. 187 In 20 II she was able to identify 43% 

of individuals in a department of health in Washington state hospital discharge database using 

newspaper stories. 188 Another study189 showed how ''data on air and dust samples from 50 homes 

in two communities in California could be combined with data released under the Safe Harbor 

provisions of the Health Insurance Portability and Accountability Act (HIPAA) to 'uniquely and 

correctly identify [in one community] 8 of32 (25 percent) by name and 9 of32 (28 percent) by 

address. "'190 

The Commission on Evidence-Based Policymaking. which EPA also cites in the 

Proposal 191 , also stresses the dangers of re-identification of data that has been stripped of direct 

identifiers. They note: "No existing statistical disclosure limitation method ... is able to 

completely eliminate the risk of re-identification," despite increasingly complex techniques that 

have been developed since the 1970s. 192 They also note the threat posed by the "cumulative 

amount of information available about individuals and businesses that could be used for reidentification,'>~93 with the threat increasing as available information grows and technology to 

allow re-identification improves. 194 

Further, the National Academies note, ''data that are most useful to legitimate researchers 

typically have characteristics that pose substantial risk of disclosure." 195 This includes 

information such as: 

detailed geographic information; 

• repeated data collection from the same subjects; 

outliers, such as people with very high incomes; 

• many attribute variables; and 

185 Rothstein, Mark A .. is deidemfjication s!!fjlcie111 to protect health priwtcy in research?. 10.9 The American 

Journal ofBiocthics 3-11.6 (2010). 186 !d. at 5. 187 Sweeney. Latanya and Abu. i\kua and \Vinn. Julia. Jdent{fying Participants in the Personal Cienome Project by 

.Vame (llpril 29. 2013 ). https://ssrn.com/abstmct·-2257732 or http:/idx.doi.org/1 0.2139/ssrn.2257732. 188 Sweeney L.. Jfarching known patients to health records in Washington 5'tate data. Han ard University. Data 

Privacy Lab (2013 ). https:/idataprivacylab.org/projects/wa/1 089-l.pdf. 139 Latunya Sweeney . .Ji Su Yon. Laura Perovich. Katherine E Boronow, Phil Brown. and Julia Green Brody~ Reidemfjicntion Risks in HJPAA Sq(e Harbor !Jata: A Sttu~v qlData From One Enr;,·onmental Health Stuc~r. 

Technology Science (/lug. 28. 20 17). https://techscience.org/a/20 17082801/. 

;qo Commission on Evidence-Based Policymaking. The Promise ufEridence-Based Policynwking. 54 (20 1 7), 

https :/ /wv .. '\V .cep.gov I content/ dam/ ccp/rcport/ceo-fi nal~report.pdf. 

'"' 83 Fed. Reg. at 18771. n. 19. 

Commission on Evidence-Based Policymaking. The Promise of Eridence-Based Pot;cymaking 53 (2017). 19J /d. at 54. 194 Jd at 55. 19 ~ National Research Council. Er:panding Access to Research Data: Reconciling Risks and Opportunities. 2l The 

National Academies Press (2005). 

46 
126 


33371.108

complete census data rather than a survey of a small sample of the population. 196 

There is increased vulnerability in "f d]ata with geographic detail, such as census block data" and 

longitudinal data obtained in panel surveys. which is otlen salient in environmental research. 197 

iii. De identification may make data sets unusable for reanalysis 

purposes. 

Work by other experts in this area suggests that deidentification can be carried out and 

help protect privacy, but it may produce datasets that have lost vital information needed for 

specific analyses. 1

" 8 Even the HIPPAA guidelines document states: "Of course. de-identification 

leads to information loss which may limit the usefulness of the resulting health information." 199 

Such results limit the utility of deidentified data sets and would not meet the requirements of the 

proposed rule which state that "EPA will ensure that the data and models underlying the science 

is publicly available in a manner sufficient for vafidation and analysis." 

Further, even if it may be technically possible to release some amount of data while 

preserving privacy in some cases, doing so imposes substantial additional costs.200 The preamble 

of the proposed rule suggests that privacy concerns can be addressed through mechanisms such 

as data masking, coding, and de-identification techniques-all of which would impose additional 

costs on researchers. The preamble also indicates that requirements for dose response data and 

availability may differ and involve a range of mechanisms such as deposition in public data 

repositories, and controlled access in federal research data centers-which would require EPA 

funding to maintain the facilities. 201 As discussed further in Section V of these comments. the 

proposed rule fails to acknowledge these costs, let alone provide any information about them or 

suggest ways to provide for them. Nevertheless, the costs can be significant, and even smaller 

costs could be prohibitive for many researchers. 

At a time when federal funding for research in environmental and public health-related 

fields has largely flat-lined, academic researchers, in particular, are likely to have few additional 

196 ld al21-22. 1()7 fd at22. 

103 Simson L. Garfinkel. De-Identificution of Personal In{ormation (NISTIR 8053). NIST (Oct. 2015) (saying the 

goals of allowing data to be used while providing privacy protections .. arc antagonistic. in that there is a trade-off 

between the amount of de-identification and the utility of the resulting data."). 

;"" HHS, Guidance Regard;ng Afethodsfor De-identification of Protected !fea!Th !f?formation in /lccordance wilh 

the Health Insurance Portability and Accountability Act (f!JPAA) Privm:y Rule. https://v.'ww.bhs.gov/hipaa/forprofess ional s/ori vacy/ special-topics/ dc-i denti tication/i ndex. h tml. 200 National Academies of Sciences. Engineering. and Medicine. Principles and obstacles for sharing dntafrom 

enrironmental health research: Workshop summarv. 46-47 The National Academies Press (2016). 

https://www.nap.edu/catalog/21703/principles-and-obstacles-ti.lr-sharing-data-ti·om-environrnental-health-research. 

::.or See. The National Academies. lrnproring Access to and Confidentiality <?f Research Data: Report of a Workshop, 

National Academies Press 48 (2000) (At present. [costs for federal research data centers! are being covered partly by 

federal agency budgets and partly by user fees. The Census Bureau's research data centers have been supported in 

part by grants from the National Science Foundation and NIA, but may eventually have to recover more oftheir 

costs from users."), 

47 
127 


33371.109

funds available to undertake these activities 202 This raises additional concerns-if researchers 

funded by industry are generally able to support the additional costs of making data publicly 

available, while academic researchers are far less likely to be able to do so, EPA's proposed 

approach could institutionalize a dangerous bias in the source of studies that EPA is allowed to 

use for regulatory activity. 

With respect to the potentially very large costs that would accrue to EPA, EPA's proposal 

provides no indication that any funding to support such activities would be available. EPA 

funding is at its lowest level since the 1980s. 203 Absent a significant change in Congressional 

priorities, any EPA expenditures for the purposes of supporting making data publicly available 

would necessarily require cutbacks in other critical areas of environmental protection, which 

might include supporting additional research, conducting inspections, issuing permits, setting 

standards, or many other activities. EPA's Proposal includes no discussion of whether funds 

would be made available, nor whether other activities would be sacrificed, whether these tradeoffs would make any sense, and what the overall impacts might be on public health and the 

environment. 

B. The Proposal Will Not Advance the Supposed Cause of "Transparency" 

Upon Which it is Based. 

The Proposal does not present or support the case that public accessibility to underlying 

data is necessary to vet scientific research-which, as discussed above, it is not-but even if it 

was, as discussed above, the scientific community is already taking steps to make underlying 

data publicly available where feasible, with the widespread understanding that this is neither 

necessary nor appropriate in all cases. 204 The Proposal does not examine the policies and 

practices that are already working to make data publicly available where feasible, the extent to 

which existing policies may already be sufficient to meet EPA's alleged transparency goals, or 

the reasons why some data is still not released publicly. Still less does EPA question whether this 

proposal would add anything to the current efforts, or whether it would have any effect 

whatsoever in increasing public accessibility of data. 

I. Where there are lower hurdles to making data publicly available, this is 

alreadv commonly occurring, with support trom various initiatives. 

20' See, American Association tor the Advancement of Science, Trends in Federal Research by Discipline FYI 970-

2017, chart, (last updated .July 20 18). http://mcmprodaaas.s3.amazonaws.com/s3 ts-public/Disc1 O.ipg''RrBDGaSpG5edeDsiBRyoQvApdami0s40. 

'"'Compare FY 2018 budget of$5.655 billion (EPA, FY 2018 Budget in /3ri~f'(May 2017)) and projected FY 2019 

EPA budget of$6.146 billion (EPA "'ews Release, EPA FJ' 2019 Budget Proposal Released (Feb. 12. 2018). 

https://www.epa.gov/newsreleasesiepa-fy-2019-budQet-proposal-released) with fiscal year 20 ITs budget of $8.058 

billion and historical budgets (EPA's Budget and Spending. https:/1\\ww.cpa.gov/planandbudgctlbudget (last 

accessed .lui) 26. 2018)). 

See National Academics of Sciences. Engineering. and Medicine, Principles and ohstacle.r.:for sharing data from 

enriranmentaf health research: Workshop :·;wmnm)J. The National Academies Press (2016). 

https :/ /v,v·;w. nap .ed u/ catalo g/2 1 703 /pri nci p les-and-obstacl cs-t()r-shari n g -data-fro m-cnv i ronmenta 1-health-research. 

48 
128 


33371.110

There are already various ongoing initiatives to make scientific data and models more 

commonly publicly available, where appropriate, as discussed more below. For example, EPA 

cites the ongoing implementation of the 2016 Plan to Increase Access to Results of EPA-Funded 

Scientific Research.105 This Plan aims to maximize access to "research data underlying a 

publication'' resulting from EPA-funded rescarch. 206 It is worth emphasizing the Plan also 

exempts "research data [that] cannot be released due to one or more of constraints, such as 

requirements to protect confidentiality, personal privacy, proprietary interest, or property 

rights."207 There is also a 12-month embargo period before publications are made publicly 

available.208 The Plan also explicitly indicates that 

[i]t is important to recognize that some research data cannot be made fully available to 

the public but instead may need to be made available in more limited ways, e.g., 

establishing data use agreements with researchers that respect necessary protections. 

Whether research data are fit!ly available to the public or available to researchers 

through other means does not i!ffect the validity of the scientific conc/usionsji·om peerreviewed research pub/ications 209 

EPA also mentions the data availability policies or requirements of many scientific 

journals (although EPA does not specifically discuss any of these policies or indicate how or 

why they are not sufficient to address EPA's concerns).210 Thus, where there arc not significant 

barriers due to costs, or contidentiality or other concerns, there arc increasing mechanisms to 

encourage scientists to make their data meaningthlly and responsibly publicly available, and in 

response to these mechanisms, scientists frequently do so alrcady. 211 

2. EPA ·s proposed approach does not require researchers to make underlying 

data publicly available. 

There are multiple real and significant barriers to the public release of underlying data 

from some studies, and the Proposal cites no reason to believe that, in the majority of cases 

where data is not already released, one or more of those barriers are not present. Because those 

barriers are significant, this is not a situation where creating an incentive to private action is 

likely to be sufficient to drive such action where it is not already occurring. 

205 X3 Fed. Reg. at 18770. 20<! EPA. !'fan to Increase Access to Results qf EPA-Funded Sdentific Research 11 (Nov. 291 2016). 

https ://vvww. epa. gov /si tes/production/tlles/20 16-1 2/ documentslepascient i ti crcsearchtransperancyplan.pd f. 

"" ld at II. ~08 /d. 

209 /d. at 4-5 (emphasis added). 

"" 83 Fed. Reg. at 18.770 (stating that the policies and recommendations EPA considered were .. informed by the 

policies recently adopted by some major scicntitic journals and cites to "related policies from the Proceedings of the 

National Academy of Sciences. PLOS ONE. Science. and Nature.''); 83 Fed. Reg. at 18.771 n. 20 (claiming the 

•·policies or recommendations of publishers Taylor & Francis. Elsevier. PLOS. and Springer Nature'' support the 

Proposal because they require authors to deposit the data underlying their studies in public data repositories). 

" 1 Jeremy Berg. Obfi1scating with transparency. 360 Science 133 (Apr, 13. 2018), 

http:i/scicnce.sciencemag,org/content/360/63 85/133/tab-pdf ("Increasingly. many publications. including those trom 

the Science family ofjournals. are linked to underlying data in accessible forms in repositories where they are 

readily available to interested parties. particularly those who seck to reproduce results or extend the analysis:'). 

49 
129 


33371.111

Yet with respect to release of data, the Proposal would only create an incentive for 

private action, not an actual requirement that data be released, First. this Proposal addresses data 

produced and held by external scientists, not data held by EPA itself or that EPA has authority to 

gain access to, Where EPA holds data, it is already governed by the Information Quality Act, 

OMB Circular A-110, and the Freedom oflnformation Act.2' 2 The Shelby Amendment required 

OMB to amend Circular A-ll 0 to require that federal agencies provide "research data relating to 

published research findings produced under an award that were used by the Federal Government 

in developing an agency action that has the force and effect of law" to the public through the 

Freedom of information AcL213 Importantly, the term "research data" excludes "[t]rade secrets, 

commercial information, materials necessary to be held confidential by a researcher until they 

are published, or similar information which is protected under law" as well as '"[p ]ersonnel and 

medical information and similar information the disclosure of which would constitute a clearly 

unwarranted invasion of personal privacy, such as information that could be used to identify a 

particular person in a research study,""' Many voiced concerns that even this provision could 

compromise scientific research and personal privacy,"' This Proposal presumably is also not 

directed at studies funded by EPA, where the researchers must generally make data publicly 

available as a condition of receiving funding, 216 There are already mechanisms by which EPA is 

making research data publicly available where it has the authority and access to do so, and only 

after carefully ensuring that doing so will not compromise privacy interests, 

Second, EPA has no authority to regulate the authors of studies or the scientific journals 

in which the studies are published, and EPA makes no attempt to regulate them directly, The 

preamble to the proposed rule states: "EPA should ensure that the data and models underlying 

scientific studies that are pivotal to the regulatory action arc available to the public."217 It further 

states that the proposed regulation is ''designed to provide a mechanism to increase access to 

dose response data and models underlying pivotal regulatory science, .... m The proposed 

regulations then state that for significant regulatory actions EPA "shall ensure that dose response 

data and models underlying pivotal regulatory science are publicly available in a manner 

212 OMB Circular A-110 Revised ll/l9/93 As Further Amended 9/30/99 36( d)( l) ("In addition. in response to a 

Freedom oflnformation Act (FOIA) request tOr research data relating to published research findings produced under 

an award that were used by the Federal Government in developing an agency action that has the force and effect of 

law. the Federal m.varding agency shall request. and the recipient shall provide. within a reasonable time, the 

research data so that they can be made available to the public through the procedures established under the FOIA,"): 

5'ee also. Lynn R. Goldman & Ellen K Si!hcrgeld. Assuring Access Ia Data for Chemical Erahwtion. 121 

Environmental Health Perspectives 149 (Feb, 2013). https:l/ehp,niehs,nih,gll\'/wpcontcnt/uploads/l21/2/ehp.12061 0 I. pdf (noting the numerous feasibility concerns that would arise were EPA to he 

required to make rU\v underlying data av<:~ilable for studies not goYcrned hy these mechanisms. given the large 

number of studies it usually relics on and that JJct that EPA is usually not in possession of the raw data. in addition 

to funding and ethical limitations). 

213 OMB Circular A-110 (36)(d)( ]), 

214 0:Vm Circular A-110 (36)(d)(2)(i}, 

:Is See Eric A. Fischer. Public Access to Data.Jf·om Federally Flmded Research: Prm·isions in Q,HB Circular A-110, 

Congressional Research Service. 13 (Mar. I. 2013), https://fas,org/sgp/crs/secrecy/R42983,pdf, 

216 U,S, EPA. Plan to Increase Access to Results olEPA-Funded Scientific Research (Nov, 29, 2016), 

b..1.!.mi.J /vvww .epa. gov /sites/production/ ti les/20 16-12/ documentslepascicnti fi crcscarcht.ransperancyplan. pdf. 

"'g3 Fed, Reg, at 18769, 

'" g3 Fed, Reg, at 18770, 

50 
130 


33371.112

sufficient for independent validation.'' 219 But (apart from studies that EPA funds) EPA has no 

authority to require those data and models to be made public. 

Hence, this proposal would regulate not the scientists, bur EPA itself. EPA would 

"ensure" that data and models underlying scientific studies "pivotal" to regulatory action arc 

publicly available simply hy barring EPA's own use in regularory aclions of any studiesfor 

which the authors do not make the data and models publicly available. The "mechanism'' 

mentioned in the preamble is not technical assistance or funding to encourage greater availability 

of data; it is simply the pressure generated by EPA's refusal to consider the results of a study if 

the authors do not release publicly the underlying data and models. The obvious question that 

EPA has neither asked nor attempted to answer in the Proposal is whether such a ban would be 

sufficient to incentivize study authors to make their data and models publicly available, where 

they have not already done so, or whether the ban willlargcly result in just limiting the studies 

available to EPA. Most of the significant barriers to release detailed above are not a matter of the 

researcher's preference, but rather take the form oflegal and ethical constraints, significant costs, 

large time investments, or the loss of proprietary data critical to a researcher's future career 

prospects. While it seems plausible that having their research applied in a regulatory context 

would be viewed as an incentive by some, or perhaps many, researchers, there is no reason to 

believe that such an incentive would be sufficient to overcome the significant barriers to public 

release of data where those barriers exist. Indeed, the party most likely to be incentivized by 

EPA's proposed requirements is the regulated community which has vested financial interests in 

regulatory actions the agency may take-a situation that almost certainly will lead to significant 

bias and conflicts of interests in the scientific evidence that the agency considers. 

Yet EPA barely acknowledges the nature of the "mechanism" it is proposing, and EPA 

certainly does not explore in any way how the mechanism would operate or whether it would be 

effective in driving release of data. Still less does EPA admit that the primary effect of this 

approach is very likely to be the exclusion of critical valid scientific studies from EPA's 

consideration. Finally, EPA utterly fails to contemplate what the etTect of such exclusion would 

be on EPA's ability to adopt regulatory standards that protect public health and the environment. 

C. The Proposal does not Acknowledge, Mnch Less Examine, its Likely Actual 

Effect-Reducing the Quality and Quantity of Studies upon which Regulatory 

Decisions are Based. 

I. EPA fails to recognize that forcing the disclosure of all data and models 

would have harmful effects on the quality and quantity of scientific research used 

by EPA. 

Although it appears highly unlikely that this proposal would drive additional data to be 

released, EPA presumes otherwise, and fails to recognize the harms that would likely result if 

EPA actually were successful in finalizing the rule. One reason researchers are particularly 

cautious about releasing human subjects data is that they understand that public willingness to 

'" 83 Fed. Reg. 18773. 

51 
131 


33371.113

participate in research studies depends upon protecting the privacy of the participants. Risks of 

privacy breaches and researchers' inability to control use of subject data will undermine potential 

participants' confidence in scientists' ability to protect their information.220 This will likely 

reduce participation in studies or even lead to biases in responses from participants.221 It could 

also result in attrition of participation by select subpopulations, particularly those who may be 

most vulnerable, such as children or people with disabilities or disease, or those with the most to 

protect. such as high socioeconomic populations. Reduced participation and particularly reduced 

participation among select subpopulations will reduce scientists' ability to draw meaningful 

inferences from their results to broader populations, the whole of which EPA is charged with 

protecting. 

In addition. the prospect that their research would not be used if researchers were unable 

to make their data public is likely to deter researchers from even engaging in environmental 

health research, particularly research involving human subjects.222 Lynn Goldman and Ellen 

Silbergeld conclude that a requirement by EPA that researchers release raw data underlying 

studies reviewed for rulemakings on pesticides and chemicals "would not be tenable" and would 

in tact "have a chilling effect on the engagement of the global scientific community in research 

relevant to the protection of human health and the environment."223 Overall, the result will be to 

diminish and undermine the strength of the scientific information available to EPA. 

2. Because EPA will be barred ti·om using many valid scientific studies with 

nonpublic data, the net effect ofthis proposal will be to harm, not strengthen, 

EPA's use of science in the regulatory process. 

The most damaging aspect of EPA's proposal is that it will bar EPA from using many 

valid scientific studies that provide critically important information supporting regulatory 

standards and requirements. This will significantly harm, not strengthen, EPA's use of science in 

the regulatory process-especially since the public availability of data is neither necessary nor 

sufficient to ensure the validity of the studies EPA relies upon. It is clearly arbitrary and 

~~0 ,)'ee Eugenia Economos. Farm worker Association of florida. Testimony at EPA Public Hearing on Proposed Rule 

'·Strengthening Transparency in Regulatory Science·· (July 17, 20 18): Leila Jamal ct. aL Research Parhcipan!s' 

Affitudes Tmrards !he C'OI?fidentiality q[Genomic Sequence Information. 22 Eur. J. Hum. Genetics 964 (2014). 

https:l/wwvi.ncbi.nlm.nih.gov/pmc-/articles/PMC4350593/. 

221 Christine Lothen~K!inc eta!.. Truth and Consequences: Ethics, Confldenhali(v, and Disclosure in Adolescent 

Longitudinal Prevention Research. 33 Journal of Adolescent Health 38j-394 (2003 ). 

"'See Augusta Wilson, Climate Sci. Legal Dci'. Fund. Testimony at EPA Public Hearing on Proposed Rule 

"Strengthening Transparency in Regulatory Science .. (.lui) 17. 20 18). https:i/www.csldf.org/20 181071 16/why-weoppose-to-thc-epas-propo~ed-transparencv-rule/ (''This could have a deeply concerning chilling effect on the 

conduct of important human health studies. Privacy concerns could influence what science gets done and \vhat does 

not. Lines of scienti tic inquiry that would have been pursued may not be. The quality of data may be poorer than it 

otherwise \vould have been."); Augusta Wilson. Big Tobacco's Smoke and ;\lirrors Re\·h·ed by Pruitt's 5'cience 

Tran.1parency Policy. The Hill (June 4. 2018. 5:00PM). http:/lthehill.com/opinion/energy-cnv_i_ronment/390638-bigtobuccos-smoke-and-mirrors-rcvivcd-bv-pruitts-science ("Good scientists may understamlably hesitate to pursue 

important lines of scientific inquiry if doing so will make them targets for regulators. interest groups and legislators 

who seck to impugn their credibility and troll through their em ails looking for wa)S to publicly embarrass them:·). 22' Lynn R. Goldman & Ellen K SilbergelJ. Assuring Access to Data for Chemical EwJ!uation. 121 Environmental 

llealth Perspectives 149. 150 (Feb. 2013). https:/lehp.nichs.nih.gov/wp-content/uploads!l2112/chp.J2061 Ol.pJf. 

52 
132 


33371.114

capricious for EPA to sacrifice the agency's use of the best available science under these 

circumstances. 

a) The prohibition on using studies with underlying non public data 

will operate to exclude quality research results from EPA's regulatory 

process. 

The next subsection provides an extensive discussion of some of the types of studies and 

specific studies that EPA would be unable to use under the Proposal. 224 Prior analyses by the 

Congressional Budget Ortice of related legislative proposals have also concluded that public 

availability requirements would significantly reduce the number of studies EPA relies uponperhaps by as much as one-half.'25 Bizarrely, however, EPA does not even mention this probable 

effect ofthe Proposal, let alone provide information on which particular studies or types of 

studies would be excluded (absent a case-by-case exemption). Further, EPA utterly fails to 

consider what the effects of such exclusions could be on EPA's ability to develop and support 

standards to protect public health and tbe environment. There arc many areas where these effects 

might be extremely damaging, as the examples below detail. 

Not only would this proposal exclude valid studies, but it may well disproportionately 

exclude high quality studies. Some of the most robust and informative environmental health 

studies arc human subjects studies with a large number of geographically distributed participants 

who are tracked over very long periods of time. These attributes make the results of these studies 

especially useful in regulatory decision making, since they are more representative of the 

population being addressed and provide information on exposure and health effects over a period 

of time. But these are also the attributes that make public release of the underlying data most 

difficult, and frequently impossible, as discussed above in Section II.A.I. Excluding these 

studies is highly likely to distmt and undermine regulatory decision making by removing support 

for standards that are actually health protective. EPA has not identified any harms it is aiming to 

address through this Proposal, but whatever they are perceived to be, it is hard to see how they 

could outweigh the harm from barring EPA from considering the best available scientific 

information. 

This Proposal also could be particularly harmful to EPA's ability to act in areas where the 

science is less developed, such as emerging threats. If there are a relatively small number of 

studies, the inability to consider some or all of them could cripple EPA ·s ability to act. This is 

224 Note that EPA has proposed to allm .. · the Administrator to grant exemptions to the prohibition on a case-by-case 

basis. but the hurdle of requiring case-by-case determinations is so high (EPA relics on roughly 50,000 studies per 

year according to the CBO) and the criteria are sufficiently stringent (public availability must be ·'not feasible." 

which may well exclude. e.g .. cost concerns) thnt it appears most plausible to assume that many studies will not be 

granted an exemption. See Section I.B.4 for further discussion. 005 See Susanne S. Mehlman. Jon Sperl & Amy Pctz. Cong. Budget Ot11ce. H.R. 1030: Secret Science Reform Act of 

2015 at 2-3 (20 15) (''CBO expects that EPA ... would base its future work on fewer scientific studies .... CBO 

expects that the agency would probably cut the number of studies it relics on by about one-half .... ''); Jon Sperl & 

Amy Petz. Cong. Budget Office. H.R. 1430: Honest and Open New EPA Science Treatment (HONEST) Act of 

2017 at 1-2 (20171 ("EPA officials have explained to CBO that the agency would implement H.R. 1430 with 

minimal funding .... That aprroach to implementing the legislation would significantly reduce the number of 

studies that the agency relies on . . '"). 

53 
133 


33371.115

precisely the type of situation where a proactive early response could avoid extensive 

contamination (which is expensive to address) and multiple exposures (which are impossible to 

reverse), and the resulting adverse outcomes. Yet, apart from a question about how to apply the 

proposed rule to existing administrative records such as for the NAAQS, the closest EPA comes 

to hinting at the possibility of the regulatory and public health effects of excluding valid studies 

is when EPA asks the public to comment "on the effects of this proposed rule on individual EPA 

programs." None of these extremely consequential impacts of the Proposal are acknowledged or 

explored in any depth in the Proposal. 

b) Examples of scientific studies that would be excluded 

The proposed rule seeks to "ensure that dose response data and models underlying pivotal 

regulatory science are publicly available in a manner sufficient for independent validation."226 

The proposal indicates that "[i]nfonnation is considered 'publicly available in a manner 

sutlicicnt for independent validation· when it includes the information necessary for the public to 

understand, assess, and replicate findings.''127 Further. footnote three of the proposal states: 

Historically, EPA has not consistently observed the policies underlying this proposal, and 

courts have at times upheld EPA's use [sic) non-public data in support of its regulatory 

actions. See Coalition of Battery Recyclers Ass 'n v. EPA, 60./ F. 3d 613, 623 (D.C. Cir. 

2010); American Trucking Ass 'ns v. EPA. 283 F.3d 355, 372 (D.C. Cir. 2002). EPA is 

proposing to exercise its discretionary authority to establish a policy that would preclude 

it from using such data in future regulatory actions.228 

Taken together, EPA is proposing to prohibit the use of studies involving dose response 

data and models in significant regulatory decisions where the underlying data are not publicly 

available. Such a prohibition would affect virtually all pending and future regulatory actions and, 

if applied retrospectively, past regulatory actions. Regulatory actions would not reflect the best 

available science, leading to inadequate or absent critical public health and environmental 

protections. 

Eight examples of pending, past, and future regulatory actions that are themselves put at 

risk from the proposed regulation, or cite to studies that under the Proposal may not be able to be 

utilized in future actions, explained in more detail below, include: 

proposed bans of trichloroethylene (TCE) for use in vapor degreasing, 

aerosol degreasing, and spot cleaning in dry cleaning facilities under TSCA 

section 6(a);229 

"'' 83 Fed. Reg. at 18773 (emphasis omitted). 201 !d. at 18773-74. 

!d. at 18769 n.3. 

""Trichloroethylene (TClo): Regulation of Usc in Vapor Degreasing Under TSCA Section 6(a). 82 Fed. Reg. 7432 

(.ian. 19. 2017): Trichloroethylene: Regulation of Certain Uses Under TSCA ~ 6(a). 81 Fed. Reg. 91.592 (Dec. 16. 

2016). 

54 
134 


33371.116

proposed ban of methylene chloride for usc in paint and coating removal 

under TSCA section 6(a); 230 

• final rule setting formaldehyde emission standards for composite wood 

products under TSCA Title VI; 231 

• National Primary Drinking Water Regulation for arsenic under the 

SDWA; 232 

• NAAQS for oxides of nitrogen under the CAA; 233 

NAAQS for ozone under the CAA; 234 

forthcoming proposed National Primary Drinking Water Regulation for 

perchlorate in development under the SDW A; 23' and 

future regulatory action on the perfluoroalkyl substances (PFASs) 

perfluorooctanoic acid (PFOA) and pcrfluorooctane sulfonate (PFOS) under 

SDW A and Comprehensive Environmental Response, Compensation, and 

Liability Act (CERCLA).236 

Explanations of the likely effect ofEPA's Proposal on these regulatory activities arc described 

below. 

Proposed bans of TCEfor use in vapor degreasing, aerosol degreasing, and spot cleaning in 

dry cleaning facilities under TSCA section 6(a) 

EPA has proposed two regulations under TSCA section 6(a) to ban the use ofTCE in 

vapor degreasing, aerosol degreasing and spot cleaning in dry cleaning facilities. 237 Exposure to 

TCE is linked to several adverse health outcomes, including liver and kidney issues, 

developmental effects, and several forms of cancer.238 The scientific basis for these proposed 

regulations is provided in the agency's 2014 risk assessment: TSCA Work Plan Chemical Risk 

Assessmenl, Trichloroethylene: De greasing, Spot Cleaning and Arts & Crafts Uses 239 which 

'

3

" Methylene Chloride and N-Methy lpyrrolidonc; Regulation of Certain Uses Under TSCA Section 6(e). 82 Fed. 

Reg. 7464 (Jan. 19. 2017). 

Formaldehyde Emission Standards lor Composite Wood Products. 8I Fed. Reg. 89.674 (Dec. I2. 20I6). 

National Primary Drinking \Vater Regulations: Arsenic and Clarifications to Compliance and Ne\\' Source 

Contaminants Monitoring. 66 Fed. Reg. 6976 (Jan. 22. 2001). 

Review of the Primary National Ambient Air Quality Standards ti.w Oxides of Nitrogen. S3 Fed. Reg. I7.226 

(Apr. IS. 20 IS). 

OH National Ambient Air Quality Standards tor Ozone. 80 Fed. Reg. 65.292 (Oct. 26. 20I5). 

m Drinking Water: Regulatory Determination on Perchlorate. 76 Fed. Reg. 7762 (Feb. II. 2011 ). 

"''Press Release. EPA. In Case You Missed It: ·'EPA Chief Vows that Clean Drinking Water is National Priority'' 

(May 22. 20 18). https://w\V\\·.epa.gov/ncwsrclcases/case-you-misscd-it-epa-chief-vmvs-clean-drinking -watcrnational-prioritv. 

'-" 82 Fed. Reg. at 7432; 8I Fed. Reg. at 91.592 238 82 Fed. Reg. at 7435-36. 

EPA. Oflice ofChem. Safetv & Pollution Prevention, EPA Doc. No. 740-R l-4002, "TSCA Work Plan Chemical 

Risk Assessment: Trichloroethylene: Degreasing. Spot Cleaning and At1s & Cratls Uses" (20I4) fhereinatler TCE 

Work Plan Risk Assessment], https:llwww.epa.gov/sites/productionltlles/2014-

II/documents/tce opptworkplanchemra tina! 0624I4.pdf. 

55 
135 


33371.117

drew heavily from the 2011 EPA Integrated Risk Information System (IRIS) Toxicological 

Review ofTC£.240 As noted in the 2014 work plan risk assessment 

EPA/OPPT's work plan risk assessment for TCE is based on the hazard and doseresponse information published in the toxicological review that the U.S. EPA's [IRIS] 

published in 2011. EPA/OPPT used the TCE IRIS assessment as the preferred data 

source for toxicity information .... The TCE IRIS assessment used a weight-of-evidence 

approach, the latest scientific information and physiologically-based pharmacokinetic 

(PBPK) modeling to develop hazard and dose-response assessments for TCE's 

carcinogenic and non-carcinogenic health effects .... Development ofTCE's hazard and 

dose-response assessments considered the principles set forth by the various risk 

assessment guidelines issued by the National Research Council and the U.S. EPA.241 

EPA clearly found the TCE IRIS assessment to be scientifically rigorous. EPA made this 

determination without the data underlying the key, peer-reviewed studies242 used in the 

assessment being publicly available. EPA's proposed science rule would preclude the use of 

these studies, severely jeopardizing the fate of the proposed TCE bans and allowing high-risk 

uses ofTCE to continue. 

Proposed ban of methylene cltloritlefor use in paint and coating removal under TSCA section 

6(a) 

EPA has proposed a ban on the use of methylene chloride in paint and coating 

removers. 243 Methylene chloride is associated with a number of hazardous health effects, 

including impaired visual and motor functions, respiratory irritation, headaches, nausea, and 

death 244 The scientific basis for this proposed regulation is provided in the agency's 2014 risk 

assessment, TSCA Work Plan Chemical Risk Assessment: Afethylene Chloride: Paint Stripping 

Use. 245 The work plan risk assessment for methylene chloride identified both cancer and noncancer risks resulting from exposure to the use of methylene chloride in paint and coating 

0

" 1 EPA. EPA/635/R-09/0 II F:·Toxicological Review of Trichloroethylene"" (20 I 1 ). 

https://ctbub.epa.gov/ncea/iris/iris documents/documents/toxrevie\vs/0 199tr/O 199tr.pdf. 041 TC'E Work Plan Risk Assessment at 65. 210 The key studies used by EPA to derive the noneancer toxicity values for TCE are Deborah E. Keil et al., 

Assessment of Trichloroethylene (TCE) Exposure in :\furine Strains Genetically-Prone and :Von-Prone to Develop 

,"utoimmune Disease. 44 .1. Envtl. Sci. & Health. Part A 443 (2009); Margie M .. Peden-Adams et al.. De,·elopmental 

Jmmunotoxicity <?[Trichloroethylene ITCE): Studies in B6C3FJ Mice, 41 .1. Envtl. Sci. & Health. Part A 249 (2006). 

and Paula D. Johnson ct a!., Threshold ofTrichloroethylene Contamination in Maternal Drinking Waters l~fjecting 

Fetal Heart De.·e/opment in rhe Rat. Ill Envtl. Health Persp. 289 (2003). The key studies used by EPA to derive 

the cancer toxicity values tor TCE are B. Charbotel et al.. Case-comrol Study on Renal Cell Cancer and 

Occupational Trichloroethylene Exposure in the Arve Valley (f'l·ance) (2006); and Ole Raaschou-Nielsen et al., 

Cancer Risk Among fVorkers at Danish Companies UsinK Trichloroethvlene A Cohort ,)'tudy, 158 Am . .1. 

Epidemiology 1182 (2003 ). 

:o 82 Fed. Reg. at 7464. 

'" ld at 7468~ EPA. Ot1icc ofChcm. Safety & Pollution Prevention. EPA Doc. No. 740-R 1-4003. TSCA Work Plan Chemical 

Risk Assessment: Methylene Chloride: Paint Stripping Use (2014) [hercinaf\er Methylene Chloride Work Plan Risk 

Assessment]. https://www .epa.govlsites/productionifilcs/20 15-09/documents/dcm opptworkp!anra final.pdf. 

56 
136 


33371.118

removers. As detailed in the work plan assessment, the proposed ban notes that liver toxicity and 

central nervous system effects are the most sensitive non-cancer endpoints for chronic and acute 

exposure, respectively.246 Accordingly, these endpoints were used to evaluate the extent of risk 

resulting from exposure to methylene chloride using a margin of exposure (MOE) approach. The 

raw data underlying key studies used to derive the benchmark MOE for chronic exposure'47 and 

acute248 exposures to methylene chloride are not publicly available. As with TCE, EPA's 

proposed regulation would preclude the agency from using these key studies to support the 

proposed rule to ban methylene chloride in paint and coating removers. The effect would be to 

severely jeopardize the finalization of this life-saving ban. 

Final rule setting formaldehyde emission standards for composite wood products under TSCA 

title VI 

In 2016, EPA issued a final rule establishing federal formaldehyde emission standards tor 

composite wood products 249 Formaldehyde exposure is associated with several adverse health 

impacts, including respiratory issues, eye and nose irritation, and lung and nasopharyngeal 

cancers."0 As part of the rulemaking process, EPA conducted an economic analysis to determine 

which of several prospective regulatory actions would result in the largest net benefit after 

weighing the compliance costs that firms would incur and the public health benefits that would 

result from reduced formaldehyde exposure. 251 The monetary benefit that would result from the 

alleviation of adverse health outcomes associated with formaldehyde exposure was a core 

component of the economic analysis. Specifically, EPA calculated the annual estimated 

monetary benefits of avoided cases of eye irritation and nasopharyngeal cancer. 

246 fd at 115. 

:!.n K.D. Nitschke eta!.. J1ethylene Chloride: .4 2- Year Inhalation Toxicity and Oncogenicity Study in Rats 11 

Fundamental & Applied Toxicology 48 ( 1988). 2

-1 8 As discussed in the work plan chemical assessment for methylene chloride. EPA considered two different 

benchmark MOEs in its assessment of acute exposure risks--one derived t1·om a 1 ~hour Spacecratl Maximum 

Allowable Concentration (SMAC) and the other !rom a Califi.>rnia acute reference exposure level (REL). Methylene 

Chloride Work Plan Risk Assessment at 23. EPA preferred the SMAC-derived approach t(,r reasons articulated in 

the work plan assessment. Raw data underlying many of the key studies used to derive the SMAC are not publicly 

available (Melvin E. Andersen eta!., Physiologica!J.v Based Phannacokinetic 1Hode/ing with Dich!oromethane, its 

Metaboli!e, Carbon 1\Jonoxide, and Blood Carboxyhemoglobin in Rats and Humans, 1 OX Toxicology & Applied 

Pharmacology 14 ( 1991 ): Irma. Astrand et aL, Etposure to ,Hethylene Chloride: I. Its Concentration in Alveolar Air 

and Blood During Rest and Ewrcise and Its Jietabo/ism. 1 Scandinavian J. of Work, Env·t & Health 78 {1975): 

G.D. DiVincenzo and & C.J. Kaplan, Uptake, .Hetabolism, and £/imina/ion (~(t\1ethylene Chloride Vapor by 

Humans. 59 Toxicology & Applied Pharmacology 130 (1981 ): Jack c:. Peterson. Modeling the Uptake. Metabolism 

and beret ion of Dichloromethane by i\Ian, 39 Am. Indus. Hygiene Ass'n J. 41 ( 1978): Y.R. Putz cl al.. A 

Comparative Study <~[the EjJ'ects of Carbon A.fonoxide and Methylene Chloride on Human Pe1jOrmance. 2 J. EnvtL 

Pathology & Toxicology 97 ( 1979): Ronald S. Ratncy et al.. In Vivo Conversion of Methylene Chloride to Carbon 

Monoxide. 28 Archives ofEnvtl. Health: An lnt'l J. 223 (1974); Richard D. Stewart et al.. E<perimental Human 

Etposure to Methylene Chloride. 25 Archives ofEnvtl. Health: An lnfl .1. 342 ( 1972). 249 81 fed. Reg. at 89,674. 050 /d. at 89.677-78. 

"' EPA. Economic Analysis c>fthe Formaldehyde Standards tor Composite Wood Products Act Final Rule (20 16) 

[hereinatler Formaldehyde Standards Econ. Analysis]. Dnckel ID: EPA-HQ-OPPT-2016-0461-0037. 

57 
137 


33371.119

EPA relied on several robust, peer-reviewed studies to demonstrate the relationship 

between exposure to formaldehyde and these endpoints. For nasopharyngeal cancer, EPA 

referenced the highly regarded U.S. National Toxicology Program (NTP) Report on Carcinogens 

(RoC).252 The U.S. NTP concluded that chronic exposure to formaldehyde increases risk of 

nasopharyngeal cancer as evidenced by several key human epidemiological studies.253 For eye 

irritation, EPA relied on two epidemiological studies that examined residential exposure to 

formaldehyde. 254 Both these studies showed that the prevalence of eye irritation increases with 

heightened exposure to formaldehyde. The data underlying key, peer-reviewed studies that 

identify nasopharyngeal cancer and eye irritation resulting from formaldehyde exposure are not 

publicly available. EPA would have been forced ignore these studies were the proposed rule in 

place at the time the formaldehyde rule was developed. If the proposed rule is applied 

retrospectively, the formaldehyde rule will be at significant risk. 

National Primary Drinking Water Regulation (NPDWR) for arsenic under the Safe Drinking 

Water Act (SDWA) 

In 200 l. EPA published a final rule, pursuant to its obligations under the Safe Drinking 

Water Act, establishing a new maximum contaminant level (MCL) for arsenic. 255 Ingestion of 

high levels of arsenic can result in death, and even low-level ingestion can lead to severe health 

impacts, including skin diseases 256 As part of the rulemaking process, EPA requested that the 

National Research Council (NRC) review the agency's prior standards and risk assessments for 

arsenic as well as the available scientific data regarding the risks of arsenic exposure and 

ingestion.257 Among the critical studies that the NRC analyzed were two epidemiological studies 

performed in the 1960s and l970s that documented the relationship between arsenic in well 

water and skin diseases of an affected community in Taiwan. 258 The studies found that ingestion 

of high levels of arsenic through well water correlated to a higher likelihood of developing skin 

052 Nat"! Toxicology Program, Formaldehyde. in Report on Carcinogens (RoC). 14th ed. 2016). 

https://ntp.niehs.nih.gov/ntp/roc/content/prolilcs/formaldehvdc.pdf; Nat'! Toxicology Program. Final Report on 

Carcinogens Background Documentfor Formaldehyde (Jan. 22. 2010) (used to develop the 2011 RoC review for 

lc1rmaldehyde). 

253 !d. at J-2 (citing M. Hauptmann et al.. ,\for!ali(vfrom Solid Cancers Among Workers in Formaldehyde 

Industries, 159 Am. J. EpiLicmiology 1117 (2004); Allan Hildeshcim ct al., Occupational Exposure to I'Vood. 

Formaldehyde, and Soll'ents and Risk ufNasophmyngeal Carcinoma. 10 Cancer Epidemiology, Biomarkers & 

Prevention 1145 (200 I); Thomas L. Vaughan et aL Occupational Ecposure to FormaldehJYle and rVood Dust and 

SasophwTngeaf larcinoma, 57 Occupational & Envtl. rvled. 376 {2000); Sheila West cl aL iVon-v;raf R;sk Factors 

lor ,\asophm:vngeal Carcinoma in the Philippines_ Results from a Case-Control Study, 55 lnt'l J. Cancer 722 

11993)). 

25" Formaldehyde Standards Econ. Analysis at 4-24 to -25 (citing Lawrence P. Hanrahan et al.~ Formaldehyde Vapor 

in .Hobi/e flames: .A Cross-.S'eclional .)'un'e.y i~f'Concentrationr..· and !rritanl t._jfecl.". 74 Am. J. Pub. Health I 026 

( 1984 ): Kai-Shen Liu eta!.. Irritant Ejfi:cts of Formaldehyde Exposure in ,\labile Homes. 94 Envtl. Health Persp. 91 

(1991)). 

055 66 Fed. Reg. at 6976. 

CDC Fact Sheet. Arsenic- ToxFAQs (2007). https:/lwww.atsdr.cdc.govltoxfaqslttacts2.pdL 

.See Nafl Research CounciL Arsenic h-1 Drinking Water ( 1999). 

5iee generally id. (citing Wen~ Ping Tseng. Effects and Do,.,·e-response Relationships qf5Jkin Cancer and 8/ac:~foot 

Disease with Arsenic. l9 E1wt'l Health Persp. 109 (1977): ¥/en-Ping Tseng ct al.. Preralence (?f5'kin Cancer in an 

Endemic Area of Chronic Arsenicism in l'aill'an. 40 J. Nari Cancer lnsL 453 ( 1968}). 

58 
138 


33371.120

cancer and other skin diseases. NRC's report concluded that based on the available evidence. 

EPA's previous standard for arsenic was inadequate tor protecting the public health.159 

Following the NRC report, EPA finalized a MCL of l 0 ppb for arsenic, which was based 

on the two epidemiological studies from Taiwan.260 Both studies were peer reviewed. published 

in prestigious health and environmental journals. and have been cited numerous times by other 

researchers. Yet it is unlikely the data from these studies could be made publicly available, as the 

data are four to five decades old and include confidential individual health information. If 

applied retroactively, or if EPA re-evaluates the MCL for arsenic, the proposed rule would likely 

mean that EPA could not rely on these studies. 

National Ambient Air Quality Standards (NAAQS) for oxides t>{ nitrogen under the Clean Air 

Act (CAA) 

In 2004. EPA awarded a grant to the University of Washington to study the effects of 

long-term air pollution on the development of cardiovascular disease. More than 6,000 patients 

across the nation participated in the l 0-year study. called the Multi-Ethnic Study of 

Atherosclerosis Air Pollution Study ("MESA Air''). 261 Results from the initial study showed that 

long-term exposure to oxides of nitrogen (NO,) and fine particulate matter contributes to 

cardiovascular disease. 262 MESA Air was the first study to show the negative health effects of 

long-term exposure to air pollution. Through funding from EPA, the National Institutes of 

Health, and the Health Effects Institute, MESA Air research is ongoing.263 

On April 18, 2018, EPA published a final rule maintaining the current NAAQS for 

N0,.264 As part of the rulemaking process, EPA published the Integrated Science Assessmentfi>r 

Oxides of Nitrogen- Health Criteria265 This assessment incorporated research from MESA Air, 

including research related to modeling and statistical techniques, and was relied on by EPA in 

maintaining the NAAQS for NO, in 2018. Yet because confidential health data comprises most 

of the research's data, as well as other identifying data such as ages and addresses, it is extremely 

unlikely the underlying data can be made publicly available. Researchers seeking to use the 

study's data must formally request and be granted access to de-identified datasets and arc 

prohibited trom further distributing data reccived 266 Despite initially funding the research, under 

the proposed rule, EPA would be restricted from relying on this research in future rulemakings. 

:::59 ..._r.;ee Nat'! Research CounciL Arsenic in Drinking Willer 8~9 (1999). 

or.o EPA. Six-Year Review 2 llealth Effects Assessment: Summary Report 34 (2009) (citing Tseng ( 1977): Tseng et 

al. ( 1968)), https:/iwww.epa.gov/sites/production/tiles/20 14-12/docurnents/822r09006.pdf. 

"'' Multi-Etlmic St1u~v ofAtherosclerosis (MF:SA) Air Study. EPA (last visited Aug. 13. 2018), 

https:/ /w\VW .epa.gov /air-research/m u! ti ~eth n ic~studv-atherosclcros i s~mesa-ai r~stud v. 262 Dr. Wayne Cascio. EPA's kfESA Air .)'tudy ( 'orifirms that Air Pollution lontributes to the#/ Cause <~f Death in 

the [/S., The EPA lllog (May 25. 2016). https://blog.epa.gov/blog/2016/05/epa-mesa-air-studv/. 061 MESA AIR HOME. Univ. of Wash. Sch. of Pub. Health, Dep't ofEnvtl. & Occupational Health Servs. (last 

visited Aug. 13. 2018 ). http://deohs.vvashington.edu/mesaair/horne. 064 83 fed. Reg. at 17226. 2

" 5 EPA. EPAi6oO/R-15/-68. Integrated Science Assessment for Oxides ofNitrogen-Health Criteria (2016). 

""'Memorandum from W. Craig Johnson. MESA Coordinating Ctr.. on MESA Dcidentitied Dataset Distribution 

Policy Statement (Apr. 12. 2016). https://www.mesanhlbi.org/PublicDocs/MESA DeidcntifiedDataDistribution PolicvStatement 041220 16.pdf. 

59 
139 


33371.121

NAAQS for ozone under the CAA 

In October of2015, EPA strengthened the NAAQS for ozone/67 which is the main 

component of smog. Ozone pollution is linked to asthma and other respiratory health problems, 

and it is particularly dangerous for children and the elderly. As part of the rulemaking process, 

EPA published the Integrated Science Assessment for Ozone and Related Photochemical 

Oxidants in 2013, which reviewed the available science to build the scientific basis for the 

NAAQS. 268 In the Integrated Science Assessment, EPA relied on recent epidemiological studies 

demonstrating the causal relationship between ozone and childhood asthma as well as other 

developmental effects.269 These studies were peer-reviewed and are invaluable to ensuring that 

all people, and especially children and older adults, are protected from the dangerous impacts of 

smog. However, the studies include individual demographic and genetic data. It is unlikely the 

data could be made publicly available. Under the proposed rule, when EPA reviews the ozone 

NAAQS, the agency would likely be unable to rely on these studies. 

Forthcoming proposed NPDWRfor perchlorate in development under the SDWA 

In 20 II, EPA made a regulatory determination to develop a national primary drinking 

water regulation for perchlorate under the SDWA, based on the conclusion that ''there is a 

substantial likelihood that perchlorate will occur in public water systems with a frequency and at 

levels of public health concern."270 Underlying this conclusion is a body of literature detailing 

the health risks associated with perchlorate, namely the chemical's interference with normal 

thyroid function by inhibiting uptake of iodide into the thyroid gland. Iodide is essential to 

making thyroid hormones that regulate the body's metabolism and orchestrate fetal and infant 

brain development. In its determination, EPA cited a study by Michael Zimmermann, which 

reviews the adverse effects that iodine deficiency has on children's health.271 

Currently EPA is using peer-reviewed studies271 to develop the dose-response model 

central to deriving the maximum contaminant level goal (MCLG) for perchlorate in drinking 

water. These studies demonstrate that perchlorate exposure during pregnancy results in low 

"'

7 80 Fed. Reg. at 65292. 

"'' EPA. EPA/600/R-1 0/076F. Integrated Science Assessment lt1r Ozone and Related Photochemical Oxidants 

(20 13 ). https://www.momscleanairtorce.org/wp-content/uploads/20 I 5105/0zone-20 13-1 SA-ExecutiveStllnmarv.pd[ 

21'

9 See. e.g. Muhammad T. Salam ct al., Roles of Arginase Variants. Atopy, and O:one in Childhood Asthma. 123 J. 

of Allergy & Clinical Immunology 596 (2009); Tal at Islam et al.. Glutathione-S-transfcrasc (GSTI Pl. GSTM1. 

Erercise. O:one. and Asthma Incidence in School Cl1ildren. 64 Thorax 197 (2009). 

77 Fed. Reg. at 7762. 271 /d. at 7763 (citing Michael Zimmerman. Iodine Deficiency. 30 Endocrine Reviews 376 (2009)). 272 EPA. Post-Meeting Peer Review Summary Report: External Peer Review for EPA's Proposed Approaches to 

fl?(orm the Derivation of a }vfaximum Contaminant Level Goa/for Perchlorate in Drinking Water (Mar. 20 I 8), 

https:/iwww.regulations.gov/document''D=EPA-H Q-0 W -2016-0439-0012, Docket I D: EPA-HQ-0 W -20 16-043 9-

0012. 

60 
140 


33371.122

maternal level of the thyroid hormone T4 leading to neurodevelopmental problems in children.273 

As with the Zimmermann study, the data underlying these studies arc not publicly available. 

Under EPA's Proposal, the agency would be unlikely to rely on these studies putting at risk both 

the 20 II regulatory determination itself and EPA's ongoing work to develop the perchlorate 

NPDWR. 

Future regulatory action 011 PFOA ami PFOS u11der the SDWA and CERCLA 

In May 2018. EPA announced that the agency will begin the process of developing, under 

the SOW A, maximum contaminant levels (MCLs) for pertluorooctanoic acid (PFOA) and 

pertluorooctane sulfonate (PFOS), in addition to designating these chemicals as "hazardous 

substances,'' possibly under the Comprehensive Environmental Response. Compensation, and 

Liability Act (CERCLA).m 

EPA developed health advisories for PFOA and PFOS in 2016. The supplementary 

documents275 provided with these advisories detail the various sources of evidence that EPA 

considered in its characterization oft he health impacts of PFOA and PFOS. Among the sources 

of health effect information was the CS Health Project.276 a community-wide assessment of 

approximately 69,000 individuals living in or near Parkersburg, West Virginia, that was 

mandated as part of a lawsuit following a major release of PFOA from the DuPont Washington 

Works production plant into the area's drinking water. Based on this data set and other relevant 

studies, the researchers leading the CS Health Project concluded that there was a probable link 

between PFOA exposure and several harmful health effects, including thyroid disease, ulcerative 

colitis, kidney cancer, and testicular cancer.277 

The presiding judge sealed the data from the CS Health Project to protect participant 

privacy. m Under EPA's proposed rule. when the Agency is developing regulations for PFOAas it intends to do in the near future-it would not consider publications from the C8 Health 

Martjin Finken. et aL. /1.-/aterna/ Hypothyroxinetnia in Ear~v Pregnane)' Predicts Reduced Pe1j'ormance in 

Reaction Time Tests in 5- to 6-Year-0/d Offspring. 98 .I Clin Endocinol Metab. 1417 (20 13 ). ; Korevaar et al .. 

Association ofAlaternal Thyroid Function During Early Pregnant.)' wilh Qffspring IQ and Bra;n Aforphology in 

Childhood: A Population-Based Prospecti\'e C'ohort Study 4 Lancet Diabetes & Endocrinology 35 (2016): Victor J. 

Pop eta!., Low malerna!jl·ee thyroxine concemrations during ear~v prewwncy are associated with impaired 

psvchomotor development in in(imcy. 50 Clinical Endocrinology 149 ( 1999): Victor .1. Pop et al .. Malemal 

hypothyroxinaemia during ear~v pregnancy and subsequent child developmenl. a 3-yearfo!lolr-up slUdy 59 Clinical 

Endocrinology 282 (2003): F. Vermig!io et al., Attent;on deficit and hyperactivity disorders in the qff~pring (d mol hers exposed to mild-moderate iodine deficiency: a po.~sible norel iodine deficiency disorder in developed 

countries. 89 J. Clinical Endocrinology & Metabolism 6054 (2004). 274 Press Release. EPA. In Case You Missed It: ·•EPA Chief Vows that Clean Drinking Water is National Priority"' 

(May 22. 20 18 ). https;//wv•r'W .epa. gov I ne\vsrcl cases/ case-vo u-missed -it -cpa-ch icf-vows-c! can-drinking -waternational-priority. 

271 EPA. EPA-822-RIG-003.11ealth Effects Support Document for Pcrfluorooctanoie Acid (PFOA) (2016): EPA. 

EPA-822-RI6-002. Health Efl'ects Support Document for Pcrfluorooctane Sulf(matc (PFOS) (2016). 276 Frisbee. eta! .. the CS Health Project: Design, Methods, and Participants, 117 Envtl. Health Persp. 1873 (2009). 

https://ehp.niehs.nih .gov/vvp-contentiuploads/117 112/ehp.0800379 .pdf. 

-::.n C8 Science Panel. The 5'cience Panel Jflebsite. http://www.c8scicncepancl.~rg/index.html (last updated Jan. 4. 

2017). 

278 Frisbee eta!.. at 1876. 

61 
141 


33371.123

Project because tbe raw underlying data are not publicly available. In failing to consider such 

crucial case studies, EPA would be ignoring best available science, thereby undermining its own 

attempt to protect Americans from emerging health threats such as PFOA and PFOS. 

c) Prominent scientists and leaders in public health agree that this 

Proposal would harm science-based public health protections. 

Leading experts in public health, science, and environmental policy agree that the proposed 

rule would have far-reaching, detrimental impacts on public health and would constrain EPA's 

decision-making capabilities. By limiting the scientific studies that EPA may consider, the 

proposed rule would lead to less effective environmental policies and weaker public health 

protections. Experts have said the following: 

"[The proposed rule] will threaten the lives of real people."- Commissioners of the 

Minnesota Pollution Control Agency and Department of l-!calth279 

• "If the proposed rule is approved, science will be practically eliminated from all decisionmaking processes. Regulation would then depend uniquely on opinion and whim."- John 

P. A. Joannidis, C.F. Rehnborg Chair in Disease Prevention at Stanford University"80 

• "It does not strengthen policies based on scientific evidence to limit the scientific 

evidence that can inform them .... Excluding relevant studies simply because they do not 

meet rigid transparency standards will adversely affect decision-making processes."-

Editors of Science family of journals, Nature, Public Library a_[ Science journals, 

Proceedings o.fthe National Academic of Sciences, and Ce/f.2 81 

"Without access to the restricted data, regulatory programs could become more or less 

stringent than they otherwise would be, with consequences for both regulatory costs and 

benefits .... [the proposed rule] could have the effect of removing legal, ethical, and 

peer-reviewed studies of health effects as sources to support the agency's regulatory 

efforts.''- Members of the Science Advisory Board282 

·'[The proposed rule] would prevent the best science from informing policy decisions and 

result in weaker health safeguards." Harold P. Wimmer. National President and CEO of 

the American Lung Association283 

Letter ti·om John Line Stine. Comm·r. Minn. Pollution Control Agency. & Jan Malcolm. Comm·r. Minn. Dep't 

of Health. to E. Scott Pruitt. Adm·r. EPA (May 15. 2018). http://www.documentcloud.org/documents/4465265-

MPCA·M DH -.loint-Lcttcr-to-EPA·Science.html#documcnt/p 1 . 280 John P.A. Joannidis. All Science Should inform Policy and Regulation. 15 !'LoS Med. 5 (2018). 

http://journals.plos.org/plosmcdicine/article'!id~ I 0.13 71 /journal.pmcd .I 002576. 

:lNI Jeremy Berget aL Joint Statement on EPA Proposed Rule and Public Availability o.lData, 360 Science (20 18)1 

http://science.sciencemag.nrg/content/360/6388/eaauO ll6?utm campaign-""toc sci~mag 20 l8-05-

03&et rid~296581 0 13&et cid~2008556. 

"'Memorandum !rom Alison Cullen, Chair ofSAB Work Group on EPA Planned Actions 1(lr SAB Consideration 

of the Underlying Science to the Members of the Chartered SAB and SAB Liaisons (May 12, 2018). 

https://yoscmite.cpa.oov/sab/sabproduct.nstiE21 FF AE956B548258525 828C00808BB7 /$Fi lc/WkGrp memo 2080-

AAI4 tinal 05l32018.pdf. 

::&~Press Release. Am. Lung Ass"n. American Lung Association Strongly Opposes EPA's Proposed Rule to Limit 

Critical Health Science (Apr. 24, 2018). http://www.lung.org/about-us/mcdia/prcss-relcases/cpa-propose-limithcalth-scicncc.html. 

62 
142 


33371.124

"If [the proposed rule] had been in effect 20 years ago, the nation might have forgone 

programs that are preventing over 50,000 premature deaths each year." Environmental 

Protection Network 18 ~ 

"[The proposed rule] would greatly weaken EPA's ability to comprehensively consider 

the scientific evidence across the full array of health effects studies. This would 

negatively impact EPA public protections that reduce levels of lead, harmful chemicals. 

and tine particle pollution, among others."- 985 scientists in a joint letter to 

Administrator Pru itt285 

"[The proposed rule] would severely hamstring the agency when it comes to developing 

and enforcing public health rules by limiting the kinds ofreseareh the EPA can use in 

crafting rules." Union of Concerned Scicntists286 

''[Administrator] Pruitt is moving to rid the EPA of the science needed for effective 

regulation .... Its potential impact goes well beyond the EPA's regulatory effectiveness 

to the underlying role of science in American society." Dr. Bernard Goldstein. 

Professor Emeritus of Environmental and Occupational Health at the University of 

Pittsburgh and tlmncr EPA Assistant Administrator for Research and Development. 287 

Additionally, when the U.S. House of Representatives passed similar legislation in 2017, 

H.R. \430, numerous professional organizations raised concerns about the implications of the 

proposed legislation.288 The Environmental Data & Governance Institute (EDGI) found that: 

A bill that provided genuine provisions for public data access and usability, and did not 

focus on mandating the reproducibility of studies and on prohibiting the use of any data 

that could not be divulged to the general public in its entirety. would not be expected to 

hamper the EPA in a significant way. EDG\'s analysis ofH.R. 1430 shows that it does 

not achieve its stated goals. Instead, our research shows that H.R. 1430 would not 

promote transparency and that its passage would instead block the EPA from using the 

data it needs to fulfill its mission of protecting public health and the environment.189 

Memorandum tl·om Envtl. Prot Network on Preliminary Assessment ofPruitfs Proposed Regulation to Restrict 

EPA's Use of Sound Science 2 (Apr. 26. 2018). 

h ttps :/!docs. wixstati c .comlu gdl 486 8e0 8 bbc4 7 f8h66 84 8e4a60503 d4dd3 a9e 72 .pdf. 85 Letter !!·om 985 Scientists to E. Scott Pruitt. Adm'r. EPA (Apr. 23. 2018). https://s3.amazonaws.com/ucsdocumcnts/sciencc-and-democracy/sccret-science-letter-4-23-20 l8.ndf. 

:!85 Press Release, Union of Concerned Scientists. Scientists Oppose Pruitt's Research Restrictions (Apr. 23. 20 18), 

https://www.ucsusa.org/ne\~ress-rdease/scicntists-opnosc-new-pruitt-restrictions#. Wv,:M I Mu4vvUI. 230 Press Release. Union of Concerned Scientists, Scientists Oppose Pruitt's Research Restrictions (Apr. 23. 20 18). 

https: I /v./W\V. ucsusa.org/news/press-re! case/sci cntists-oppose-new-prui tt-restrictions#. \V v .. ·M I M u4 vy U I. 287 Bernard Goldstein. iYhy the EPA's 'Secret ,)'cience ·Proposal Alarms Public Health Experts. The Conversation 

(May 18. 2018. 6:40AM). https://theconversation.comlwhy-the-epas-seeret-science-proposal-alarms-public-bcalthcsperts-96000. 

:zss See Vivian Underhill eta!.. EnYtl. Data & Governance Initiative. Public Protections Under Threat at the EPA: 

Examining Safeguards and Programs that Would Have Been Blocked by H.R. 1430 (2017), 

https:/lenvirodatagov .orglwp-content/uploads/20 17/03/Public-Protections-under-Threat-at-the-EPA .pdt; Jon Sperl & 

Amy Petz. Cong. Budget Ot!ice. H.R. I 430: Honest and Open New EPA Science Treatment (HOl'EST) Act of 

2017 (2017). 289 See Vivian Underhill eta!.. Envtl. Data & Governance Initiative. Public Protections Under Threat at the EPA: 

Examining Safeguards and Programs that Would Have Been Blocked by H.R. 1430 IS (20 17), 

ht.Jps:l/envirodatagov .org/wp-content/uploads/20 I 7/03/Public-Protections-under-Threat-at-the-EPA .pdf. 

63 
143 


33371.125

D. EPA's Policy Rationales for its Proposal are Arbitrary and Capricious 

1. EPA arbitrarilY fails to provide a reasoned explanation for why the 

proposed rule is needed. 

In essence, EPA's proposed regulation is a solution in search of a problem-a problem 

that does not exist. The administrative record for the Proposal fails to show that the Agency's 

past regulatory decisions inappropriately relied on scientific information of questionable value. 

In fact, EPA fails to point to a single example of a case in which, in developing regulations, EPA 

relied upon a study or studies later found to be questionable or invalid. Having failed to address 

this foundational question, EPA also misses the questions that would build on that-even if EPA 

actually had used invalid science in some instance, EPA would still have to ask whether the 

underlying data for that study had been made publicly available, and if not, if the problems with 

the study could have been avoided through having made the data publicly available. 

The Proposal neither acknowledges the mechanisms EPA already uses to ensure the 

integrity of science in decision-making nor establishes that there is a problem that the Proposal is 

needed to solve. The reality is that both Congress and EPA have established an array of 

mechanisms and safeguards over the last five decades to ensure that the Agency's decisions are 

grounded in best available science. These mechanisms include review of agency science and 

decisions by EPA's scientific advisory boards, including the Science Advisory Board (SAB), the 

Clean Air Scientific Advisory Committee, Board of Scientific Counselors, the Science Advisory 

Committee on Chemicals, and the Federal Insecticide, Fungicide, and Rodenticide Act Scientific 

Advisory Panel290-a process that a work group of the SAB recently described as a "rigorous 

review process that goes beyond the typical journal peer review procedures,"291 and that the 

National Research Council recognized as playing an ''important role in helping EPA to ensure 

the credibility and quality of ... science-based decisions."292 The Proposal also ignores EPA's 

use of independent peer review processes to evaluate certain studies used in regulatory 

decisions;293 the use of transparent literature surveys that are themselves subject to peer review 

S'ee 42 U.S.C. ~ 4365 (establishing the Science Advisory Board and requiring that EPA seek its review ot: among 

other things, certain rulcmakings under the Clean Air Act Federal Water Pollution Control Act Resource 

Conservation and Recovery Act. Noise Control Act, Toxic Substances Control Act. anJ Safe Drinking Water Act); 

42 U.S. C.~ 7409 (requiring the Clean Air Scientific Advisory Committee to advise EPA on matters relating to the 

National Ambient Air Quality Standards); 7 \J.S.C. ~ 136w (requiring EPA to seek comments ti·om the FIFRA 

Science Advisory Panel on certain rulemakings under FIFRA. and to seek advice on operating guidelines for 

scientific analyses by EPA that lead to actions carrying out FIFRA): 

Memorandum by Alison Cullen. Chair. SAll Work Group on EPA Planned Actions lor SAfl Consideration of the 

Underlying Science 4 (May 12. 20 18) (observing that the Proposal ·'tails to mention that EPA has mechanisms lor 

vetting science through several expert p~mels.'' including the SAB and others). 

Nat' I Research Council. Science tor Environmental Protection: The Road Ahead 181 (2012) ("External adv·isory 

groups-including SAB. BOSC. and NACEPT-play an important role in helping EPA to ensure the credibility and 

quality of its scientific studies and science~based decisions.''). 

:<>J See. e.g.. EPA Sci. and Tech. Policy Council. Peer Review Handbook xiii. 15 (4th cd. 20 15) (noting that EPA has 

a '"long-standing history of peer review" and providing for peer review of internally generated studies designated as 

"Influential Scientific Information" or "Highly Influential Scienti1ic Assessments"): Nat' I Research Council~ 

64 
144 


33371.126

and public comment, such as the Integrated Science Assessments (ISA) that inform the National 

Ambient Air Quality Standards;'"' and independent review of EPA science programs and risk 

assessment practices by authorities such as the National Research Council. 295 Major regulatory 

decisions-and the underlying scientific bases for those decisions-arc also subject to public 

comment and judicial review, which serves as an important check on agency decisions that fail to 

properly account for the best available science. 

Thanks to these multiple and overlapping safeguards, the quality of the science 

underlying EPA decisions is robust. 296 More to the point, there is no indication that EPA science 

sutrers from the so-called "replication crisis" that the Proposal identifies as the principal reason 

for requiring the public disclosure of underlying data or models for studies used in EPA 

decisions. 297 It is telling that the sources EPA cites in support of its claims of a "'replication 

crisis"298 call into question its existence299 and in many instances promote solutions that do not 

involve access to underlying data300-such as looking at cumulative evidence using a variety of 

methods instead of over-emphasizing the results of a single study.301 It is even more telling that 

Science for Envirnnmental Protection: The Road !\head 180 (2012) ( .. In rule-making processes that rely on 

extensive reviews of scientific infOrmation. EPA generally imposes a strong preference for reliance on published, 

peer-reviewed studies. The agency·s peer review polic) states that ·peer review oC all scientific and technical 

intOrmation that is intended to lnfi.Jrm or support Agency decisions is encouraged and expected,'''). 2

'!4 See EPA. EPA/600/R-15/067. Preamble to the Integrated Science Assessments 5-25 (20 15) (describing the step,s 

EPA undertakes in preparing an Integrated Science Assessment. including extensive and transparent compilation 

and screening of relevant literature; puhlic comment and independenl review by the CASAC: and EPA's application 

of recognized frameworks in evaluating public health causation relationships). 

See. e.g., Nat" I Research Council. Review of EPA ·s Integrated Risk Information S)'srem (IRIS) Process 3 (20 14) 

(describing the charge o !'the authoring committee as encompassing a rcvlcvv of recent changes to EPA's IRIS 

program as well as to "review current methods for evidence-based reviews and recommend approaches for \Veighing 

scientific evidence for chemical hazard and dose-response assessments."): Nat'! Research CounciL Science t<w 

Environmental Protection: The Road Ahead at x (explaining that EPA asked authoring committee "'to assess 

independently the overall capabilities of the agency to develop. obtain. and usc the best available scientific and 

technologic information and tools to meet persistent. emerging~ and future mission challenges anJ opportunities"). 

See Nat' I Research Council. Science for Environmental Protection: The Road ;\head at 13 ( .. For over 40 years. 

EPA has been a national and world leader in addressing the scientific and engineering challenges of protecting the 

environment and human health.''); Wendy Wagner, Science in Regulation: A Study ofAgency Decisionmaking 

Approaches 29 (20 13) (describing EPA ·s N i\i\QS review process as ·'exemplary" and a ·'ftve-star process lor 

incorporating science into regulatory policy"). 

'"' 83 Fed. Reg. at 18770. 2

<.)

8 It is additionally unclear \.Vhat EPA means hy '"replication crisis:· and EPA appears to be misusing the term. as 

the source it cites to describes a "reproducibility crisis:· Marcus R. Munat() ct. al. A Manifesrofor Reproducible 

5'cience~ I Nature Human Behavior 1 (20 17), and another source details how "'(a]s the movement to examine and 

enhance the reliability ofresean::h expands, it is important to note that some of its basic terms-reproducibility. 

rcplicabi!ity, reliability. robustness. and generalizability-arc not standardized:· Steven N. Goodman et aL. What 

Does Research Reproducibility ;\!can?. 8 Sci. Translation Med. I (20 16 ). 

MunafO et. al. A ,\,fan[fesro.f!Jr Reproducible 5'cience. l Nature Human Behavior l (2017) ( .. Whether ·crisis· is 

the appropriate term to describe the current state or trajectory of science is dehatable ... , ,.) 100 See. e.g. Marcia McNutt. Reproducibility. 343 Science 229 (2014) ( .. [.I journals can only do so much to assure 

readers of the validity of the studies they publish. The ultimate responsibility lies with authors to be completely open 

with their methods, all of their findings. and the possible pitfalls that could invalidate their conclusions.'"). 301 .John P.A. Joannidis, Why Most Published Research Findings eire False. 2 PLoS Med. 0696,0700--01 (2005) 

(''Second. most research questions arc addressed by many teams. and it is misleading to emphasize the statistically 

significant findings of any single team. What matters is the totality of the evidence ... ). 

65 
145 


33371.127

the Proposal identifies no EPA actions that have been called into question because the science 

underlying those actions cannot be validated or replicated. In any event, the Proposal does not 

require replication of studies and only limits the cumulative evidence and context in which to 

interpret any given study--{)n)y hampering EPA's reliance on more robust scientific findings 

even if such a crisis were to exist.302 

In addition, numerous independent reviews of EPA's science-based actions by the courts, 

as well as the consistency with which the Agency has solicited and relied on the advice and 

approval of its external Science Advisory Board committees have added to the credibility of 

EPA ·s decisions. The Proposal provides no information supporting the notion that the 

overarching processes of EPA assessment of relevant scientific studies and subsequent peer 

review of such assessments, as well risk and policy assessments that EPA has developed and 

improved over time, are in any way insufficient to address the concerns that arc allegedly the 

main focus of the proposal. 

EPA's failure to identify a problem or inadequacy that new regulations arc needed to 

address is not only arbitrary-it is also contrary to the directive of E.O. 12866 which states that: 

[fJederal agencies should promulgate only such regulations as are required by law, are 

necessary to interpret the law, or are made necessary by compelling public need, such as 

material failures of private markets to protect or improve the health and safety of the 

public, the environment, or the well-being of the American people. In deciding whether 

and how to regulate, agencies should assess all costs and benefits of available regulatory 

alternatives, including the alternative of not regulating. 303 

E.O. 12866 further directs each agency to ''identify the problem that it intends to address 

(including, where applicable, the failures of private markets or public institutions that warrant 

new agency action) as well as assess the significance of that problem." 304 Before proceeding any 

further with this proposal. EPA should clearly identify the problem it is trying to solve, provide 

evidence that there is. in fact, a problem, and allow for public comment on whether a problem 

exists that could be addressed through EPA regulation. 

This is not to say that EPA· s use of science cannot be improved or strengthened-a f 

course continued improvement is always desirable. But to improve upon current practices it is 

necessary to identify what is deficient, why, how it can be corrected and the potential effects of 

such deficiency and any proposed changes to practice. EPA docs none of these. 

Marcus R. Munafo & George Davey Smith. Repeating Experiments Is Not Enough. 553 Nature 399. 399-400 

(2018). https:!/www.nature.com/articles/d41586-0 18-0 1023-3#ref~CR3 (noting that "[i]f a study is skewed and 

replications recapitulate that approach, findings will be consistently incorrect or bitJscd" and suggesting that instead . 

.. an essential protection against tlawed ideas is triangulation .. , or "the strategic use of multiple approaches to address 

one question"), 103 Exec. Order No. 12.866.58 Fed. Reg. 51.735 (Oct. 4. 1993). 

304/d 

66 
146 


33371.128

2. EPA arbitrarily fails to offer a reasoned explanation for its departure from 

existing policies that broadly reguire the agency to consider all available scientific 

information when undertaking rulemakings. 

In addition to the statutes discussed in Section LB.3 that require EPA to use the best 

available science when making regulatory decisions, a number of EPA's own policies embed this 

requirement as well. By arbitrarily limiting the science EPA considers when making regulatory 

decisions, the Proposal contravenes these policies, injuring the scientific integrity of EPA's 

actions. As discussed in more detail in Section !I.E because EPA is changing course from 

established policy, EPA must fully acknowledge and justify its decision, which it has failed to do 

in the Proposal. 

EPA's own existing Scientific Integrity Policy states: 

To support a culture of scientific integrity within the Agency, this policy ... [r]ecognizes . 

. . policy makers within the Agency weigh the best available science, along with 

additional factors such as practicality, economics, and societal impact, when making 

policy decisions. 305 

The Proposal conflicts with this policy by restricting what may be the best available science on a 

given topic from EPA's consideration solely because the underlying data cannot be made public. 

As described above, public availability of data is neither necessary nor sufficient to ensure that 

studies constitute "best available science.'' The Proposal does not acknowledge this departure 

from the agency's Scientific Integrity Policy, much less explain why such a departure is 

reasonable. 

Likewise. the Proposal is in tension with EPA's Information Quality Guidelines, 

developed in response to OMB guidelines issued under Section 515(a) of the Treasury and 

General Government Appropriations Act for Fiscal Year 200 I, which require EPA to ensure the 

objectivity of influential scientific information it disseminates by using "the best available 

science and supporting studies conducted in accordance with sound and objective scientific 

practices.''306 EPA considers information to be disseminated when EPA prepares and distributes 

information to support an Agency decision or regulation or when EPA distributes information in 

a way that suggests EPA agrees with it, that it supports EPA's viewpoint, or if in the distribution 

EPA proposes to use it to support or formulate a regulation or agency decision.J07 Thus. the 

Proposal conflicts with the Guidelines by restricting scientific studies that EPA may use to 

support regulations, which may cause it to disseminate other information to support its 

regulations that is not based on the best available science. 

105 EPA, Scientific Integrity Policy 3-4. 106 EPA. Guidelines f\1r Ensuring and Maximizing the Quality. Objectivity. Utility. and Integrity of Information 

Disseminated by the Environmental Protection Agency 21-22 (2002), 

https:/ /www. epa.gov lsi tes/production/ ft les/20 I 7-0 3/ documents/ epa· in fo·q ual it v ·guide! i nes.pd f. 3

"' !d at 15-16. 

67 
147 


33371.129

EPA's Peer Review Handbook similarly acknowledges that "EPA strives to ensure that 

the scientific and technical bases of its decisions meet two important criteria: (I) they are based 

upon the best current know ledge from science, engineering, and other domains of technical 

expertise; and (2) they are credible."303 EPA's Science Policy Council Handbook on Risk 

Characterization also requires reasonableness in the agency's risk assessments, which is achieved 

when "the characterization is based on the best available scientific information.''309 These 

policies clearly impact EPA's regulatory actions, and thus will be impacted by the Proposal. Yet 

EPA completely fails to analyze the impact the Proposal will have on its ability to comply with 

these policies and fails to explain why it is changing course or justify its decision to do so. 

Indeed, the Proposal fails to even acknowledge that the agency is changing positions. 

3. EPA's Proposal arbitrarily fails to consider and deviates from best 

practices in scientific review, which support using a broad array of information, 

informed by a "weight of the evidence" approach, rather than arbitrarily excluding 

certain studies up front. 

There is broad agreement in the scientific literature. retlectcd in EPA's own guidance. 

that a "weight of the evidence'' approach is an optimal way to analyze and synthesize an array of 

scientific information in a decision-making contcxt.310 This approach, which is described in more 

detail below. calls for scicntilic assessments to be based on a broad array of studies-retlecting 

multiple lines of inquiry. where appropriate-each or which is carell!lly weighted based on 

various indicia of credibility. This eardi.il and rigorous process is incompatible with the 

requirements of the Proposal, which would bar EPA from considering even highly credible, 

persuasive studies based solely on whether the underlying data is available. Yet the Prorosal 

never ackmm ledges the contlict between its requirements and EPA's proven practices for 

scientific assessments. and never provides any good reasons for this change of course. 

One prominent example of this •·weight of the evidence" approach is contained in EPA's 

l'remnhlc to the lntegroted Science Assessments.111 The Integrated Science Assessments are 

pollutant-specific reports that EPA produces as the scientific basis for establishing and updating 

11111 EP/\. EPA Peer Review Handbook 4th Edition A-4 (Oct. 2015). https://www.epa.gov/sites/production/liles/2016-

03/documcntsiepa peer review handbook 4th edition.pdf. 

"'"EPA, Sci. Policy CounciL Risk Characterization Handbook 18 (2000). 

https://wv.,w.epa.gov/sites/production/tilcs/20 15-l 0/documcnts/osp risk characterization handbook 2000 odt 31 n 5'e~.?. e.g, Matthev.· E. Bates. Olivia C. Massey, & Matthew D. Wood. iFeight-~f-Evidence Concept.v: Introduction 

and Application to Sediment Afanagemenr 5-8 (US Army Corps of Engineers ERDC/EL SR-18-1. Mar. 2018). 

http://www.dtic.mil/dtic/tr/fulltcxt/u211 048843.pdf (reviewing literature on development of and best practices in 

\veight-of-evidencc assessment. and observing that "Vv'ithin the US, the US EPA and its partner agencies use and 

recommend the use of WOE extensively."); Cf John P.A. loannidis. All science should itiform poli'Y and 

regulation, PLOS Med 15:5 (May 3. 2018) (''Even the strongest science may have imperfections. In using scientific 

information tOr decision-making, it is essential to examine evidence in its totality, recognize its relative strengths 

and weaknesses. and make the best judgment based on what is available."): U.S. EPA. Preamble to the Integrated 

Science Assessments (I SA). U.S. Environmental Protection Agency, Washington, DC EI'A/600/R-15/067. 2015. 

See also EPA Science Policy Council, A Swnmmy of General Assessment Factors for Erafualing !he Quality (~f 

Scientific and Technica/IJ?formalion at 2 (June 2003) (describing EPA's guiJance for carcinogen risk assessment 

~llld ecological risk assessment as 8dditiona! examples of the agency's ··\veight~of,.evidence" upproach). 311 EPA. Preamble to the lntegrotcd Science Assessments ( ISA) (EPA/600/R-15/067) (20 15). 

68 
148 


33371.130

EPA's National Ambient Air Quality Standards (NAAQS), which establish health-based 

standards for critical air pollutants. The Integrated Science Assessments arc intended to 

implement the Clean Air Act's directive to "accurately reflect the latest scientific knowledge 

useful in indicating the kind and extent of identifiable effects on public health and welfare which 

may be expected from the presence of[a] pollutant in the ambient air." 312 These are some of the 

most consequential scientific evaluations that EPA performs, in terms of the health, 

environmental, and economic impacts of the resulting standards, and they must withstand the 

highest level of technical and legal scrutiny. 313 Thus, EPA uses the very best and most defensible 

scientific methods to produce them, which are described in the Preamble to the Integrated 

Science Assessments. 

The Preamble to the Integrated Science Assessments is an ''overview document outlining 

the basic steps and criteria used in developing the Integrated Science Assessments," which EPA 

references as a companion document to each Integrated Science Assessment. 31 ' As EPA 

explains, the "Preamble describes the process of searching the literature, selecting studies for 

consideration, evaluating study quality, synthesizing and integrating the evidence, and 

characterizing the evidence for public health and welfare impacts of criteria air pollutants." 315 It 

also "describes the five-level causal framework for evaluating weight of evidence and drawing 

scientific conclusions and causal judgments." 316 Central to this scientific assessment process is 

the understanding that evidence from all types of studies. such as animal studies. human 

observational studies (cohort. time series). controlled chamber studies. and exposure 

assessments. among others. must be evaluated and incorporated into final determinations of 

ctTects. No single study alone drives the final determinations of causality; rather. the weight of 

evidence from ~cvcral.lincs of inquiry is critical.317 This framc\\Ork to c~aluate all available 

science builds upon decades ofaccrucd knowledge and thinking drawing li·om expertise across 

several disciplines. including evidence-based decision making.m 

The Preamble states: "In its evaluation and integration of the scientific evidence on health 

or welfare effects of criteria pollutants, the U.S. EPA determines the weight of evidence in 

support of causation and characterizes the strength of any resulting causal classification."319 The 

312 Learn Ahout rhe ISAs. EPA (quoting 42 U.S.C. ~ 7408(b)) (alteration in original). https:l/www.epa.gov/isalleamabout-isas (last visited Aug. 14. 2018). 

"'See Mississippi l'. EPA. 744 F.3d 1334. 1344-45 (D.C. Cir. 2013) (upholding EPA's use of the ·'weight of 

evidence·' approach in setting NAAQS. saying EPA .. evaluated the evidence as a whole through an ·integrative 

synthesis,' what it called a ·\vcight of evidence approach.' And appropriately so: one type of study might be useful 

for interpreting ambivalent results from another type. and though a ne\V study does little besides confirm or quantit~ 

a previous finding. such incremental (and arguably duplicative) studies are valuable precisely because they contlnn 

or quantify previous findings or otherwise decrease uncertainty") (citations omitted). 

}! 4 EPA. Preamble to the Integrated Science Assessments. 

https://cfpub.epa.gov/ncea/isa/recordisplav.cfm''deid=Jl 0244 (last visited Aug. 14, 20 18). 

'-15 fd 

""Id 

117 See FPA. Preamble to the Integrated Science Assessments at 22. 

JIR See Marcus R. Munafc'l & George Davey Smith. Robust research need\' many lines qj'eridence. Nature (Jan. 23. 

20 18), https:/iwww.nature.com/articlesld41586-0 18-0 1023-3#ref-CRJ. 31 " EPA. Preamble to the Integrated Science Assessments at 18. 

69 
149 


33371.131

Preamble explains in further detail: 

In the IS A, the U.S. EPA assesses the body of relevant literature, building upon evidence 

available during previous NAAQS reviews, to draw conclusions on the causal 

relationships between relevant pollutant exposures and health or environmental effects. 

IS As use a five-level hierarchy that classifies the weight of evidence for causation. This 

weight-of-evidence evaluation is based on the integration of findings from various lines 

of evidence from across health and environmental effect disciplines that are integrated 

into a qualitative statement about the overall weight of the evidence and causality 320 

Similarly, section 26 of the Toxic Substances Control Act (TSCA) requires that decisions made 

under sections 4, 5, or 6 of the law must adhere to certain scientific standards including use of 

best available science and a weight of the scientific evidence approach. 321 In its final regulation, 

Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act, 

EPA defines weight of scientific evidence as: 

Weight of scientific evidence means a systematic review method, applied in a manner 

suited to the nature of the evidence or decision. that uses a pre-established protocol to 

comprehensively, objectively. transparently, and consistently, identify and evaluate each 

stream of evidence, including strengths. limitations, and relevance of each study and to 

integrate evidence as necessary and appropriate based upon strengths, limitations, and 

relevance. 322 

Systematic review in turn requires a full review of the body of scientific evidence available, 

where study quality is evaluated largely according to methodological design and not the degree 

to which underlying data are publicly available.313 EPA's Proposal contravenes TSCA's 

requirements to apply a weight of the scientific evidence approach, as defined by the agency, by 

instating a process that, among other things, conflicts with applying a systematic review 

approach in the evaluation of chemicals under TSCA. 

The Proposal's approach of preemptively barring studies based on the unavailability of 

data cannot be reconciled with EPA's detailed policies for scientific assessment. 

4. EPA irrationally conflates scientific ·•validity" and "transparency'' with 

data availability, incorrectly assuming that eliminating the use of studies without 

publicly available data will improve scientific validity and transparencv. 

In the preamble to the proposed rule, EPA states that the intent of the regulation is "to 

strengthen the transparency of EPA regulatory science." 324 Later in the preamble, EPA states: 

''[e]nhancing the transparency and validity of the scientific information relied upon by EPA 

!d at 22 (footnote omitted). 

"' 15 u.s.c. § 2625(11). (i). 

"'40 C:.F.R. ~ 702 . .13. 303 Nafl Research Council. Review of EPA's Integrated Risk lnlormation System (IRIS) Process. 

https :/ /w\V\Io,', nap .edu/ cata! o g/ I 8 7 64/revi ew-o f.-epas-i ntcgratcd-risk -information -sv stem-i ris-proccss. 

·"' 83 Fed. Reg. at 18.768. 

70 
150 


33371.132

strengthens the integrity of EPA's regulatory actions and its obligation to ensure the Agency is 

not arbitrary in its conclusions." 325 EPA then leaps to the unexplained conclusion that barring 

the use of studies without publicly available data will enhance transparency and validity. EPA's 

assumption that data availability (or "transparency'' in the form of data availability) ensures the 

use of valid science or its equivalent to using the best available science is manifestly incorrect, 

and hence provides an irrational basis for the proposed rule. In fact, neither data availability in 

particular, nor transparency in general, is equivalent to or a guarantee of "validity" in scientific 

studies. 

a) EPA arbitrarily fails to explain why EPA ·s existing mechanisms 

arc inadequate to ensure the scientific integrity of its actions. 

The Proposal ignores both the available approaches embraced by the scientific 

community and the record of past EPA assessments, which reveal alternative methods for 

ensuring the credibility of potentially useful scientific studies. These alternatives include. but arc 

not limited to: confidential sharing of data with independent research teams that are in a position 

to validate results; comparisons of research findings with the results of other peer-reviewed 

research efforts, including through meta-analyses and literature reviews that are designed to shed 

light on consistent findings across studies; and strong peer-review processes led by scientific 

journals, by EPA. or by advisory bodies such as the SAB. 326 Indeed, the SAB workgroup that 

examined the Proposal expressly noted its failure to acknowledge any of these mechanisms: 

The proposed rule fails to mention that there are various ways to assess the validity of 

prior epidemiologic studies without public access to data and analytic methods. For 

example, the Health Effects Institute (HE I) conducted a re-analysis of the influential 

Harvard Six Cities and American Cancer Society (ACS) epidemiologic studies and was 

able to replicate its findings and to assess the robustness of the findings via sensitivity 

analysis ... in this particular case, an unusually rigorous form of peer review and 

independent reanalysis. coupled with many follow-up studies, has accomplished a 

measure of confidence in findings without public access to data and analytic methods .... 

The proposed rule fails to mention that EPA has mechanisms for vetting science through 

several expert panels .... For example, the EPA CASAC routinely reviews and evaluates 

epidemiologic and toxicological studies that are the basis for dose-response relationships 

used in risk and exposure assessments for air pollutants regulated under the National 

Ambient Air Quality Standards. Although such mechanisms do not typically engage in 

reanalysis of original data using the same methods as the original investigators, they do 

entail a rigorous review process that goes beyond the typical journal peer review 

procedures 327 

/d. atl8.769. 

See, e.g, Letter to Acting Administrator Wheeler from Marcia McNutt. President of the National Academy of 

Sciences. C.D. Mote. Jr .. President of the National Academy of Engineering. and Victor J. Dzau. President of the 

National Academy of Medicine 2 (July 16. 20 18) ("The National Academies have developed a long-standing body 

ot'work that demonstrates scientific literature can be evaluated in a transparent and objective manner without 

complete disclosure of the underlying data.'"). . 

"'Memorandum from Chair of the SAB Work Group on EPA Planned Actions lbr SAB Consideration oftbe 

Under!;ing Science. Alison Cullen. to Members of the Chartered Si\B and SAB Liaisons 4 (May 12. 2018). 

hltps:l/yosemite.epa.gov/sablsabproduct.nst!/E2l FF AE956B548258525828C00808BB 7 /$File/WkGro memo 2080-

AA 14 tina I 051320 l8.pdf. 

71 
151 


33371.133

EPA scientific assessments typically begin with expert staff identifying and assessing 

peer reviewed studies and studies published in reputable scientific journals. This includes 

examining the strengths and weaknesses of individual studies, including factors such as design, 

the reputation and past work of the researchers, quality assurance, methods and analyses. This is 

followed by a broader look to examine the consistency and coherence ofthe study with respect to 

the tlndings of similar study types across multiple studies, as well as a more integrated 

assessment of the weight-of-evidence that considers multiple lines of scientific evidence. The 

assessments are in turn peer reviewed by EPA scientific advisory committees as well as the 

public.328 In certain exceptional cases, reanalysis by EPA or competent third party investigators 

can provide some additional credibility. 

As the SAB workgroup that examined the Proposal noted, the record of EPA's treatment 

of the evidence in the case of two landmark fine particle epidemiology studies shows how 

scientific researchers and EPA used all of these approaches in examining the association between 

long-term exposures to fine particles and mortality. This effort began with Harvard's "Six Cities" 

study, reported in (Dockery et al.. 1993).329 The researchers initially sought to reproduce their 

initial findings using a data base with a much larger number of subjects and cities and did indeed 

reproduce those findings (Pope et al., 1995) (see below).330 By 2009 enough new evidence had 

accumulated for EPA's integrated assessment for particulate matter to conclude that the number 

of large U.S. cohort studies, together with supporting evidence from other epidemiology and 

toxicological studies were sufficient to infer a causal relationship between long-term PM2.5 

exposures and mortality and cardiovascular effects. This conclusion regarding causality (the 

strongest finding possible under the causality classification methodologyl31 ) based on these 

studies was endorsed by the external Clean Air Scientific Advisory Committee (CASAC), which 

noted: "The five-level classification of strength of evidence for causal inference has been 

systematically applied; this approach has provided transparency and a clear statement of the level 

of confidence with regard to causation, and we recommend its continued use in future lSAs." 332 

(Samet, 2009). Thus, the link between particulate matter exposure and mortality that was 

observed in the Six Cities study has been vetted through multiple mechanisms that have 

confirmed the validity of the findings without public access to the underlying data-including 

extensive reanalysis using larger datasets with longer duration of follow up and different 

statistical methods; reproduction and corroboration with independent studies using distinct 

populations and methodologies; and rigorous external review by independent scientists. 

' 28 See, e.g. EPA. Preamble to the Integrated Science Assessments 3. Figure II. (20 15) 

https://cfpub.epa.gov/ncca/isa/rccordisplay .cfm?dcid--3 1 0244. 329 Douglas W. Dockery et al.. An Association Between Air Pollution and ;\4orlaliry in SLt ( '5. Cities. 329 Nevi Eng . 

.1. Med. I 753 (2003). 33° C. Arden Pope. Ill eta!.. Particulate Air Pollution as a Predictor ofi\Iortalit}' in a Prospectire Stur~v of U.S 

. .Jdults. 151 Am . .1. Respiratory & Critical Care Me d. 669 ( J 995). 

:m The Preamble to the Integrated Science Assessments Sections describes the tivc-icvcl hierarchy that classifies the 

weight of evidence for causation and methodology to make the determination. and "causal relationship·· is the 

strongest tlnding. 

' 3' Letter from Dr. Jonathan M. Samet. Professor & Chair, Dep't of Preventive Mcd. Univ. ofS. CaL to Lisa P. 

Jackson. Adm'r. EPA (Nov. 2. 2009). 

72 
152 


33371.134

The Proposal says virtually nothing about the use of these existing mechanisms in EPA's 

current scientific assessment practices, or the level of confidence those mechanisms afford in 

EPA's regulatory science. Yet despite the proven track record of these mechanisms in assuring 

the validity of landmark studies such as the ACS and Six Cities studies, the Proposal would 

effectively reject their use and require EPA instead to exclude consideration of studies based on 

the sole criterion of public availability of underlying data. The Proposal's failure to explain this 

choice is arbitrary and capricious. 

b) EPA arbitrarily equates data availability with valid science. 

As discussed in detail in Section II.C.2. the absence of publicly available underlying data 

docs not make the results of a study invalid or even suggest that the study is likely to be invalid. 

Nor has EPA presented evidence to suggest that studies with publicly available underlying data 

are more likely to represent strong science than studies without such data availability. As 

discussed in Section I I.A. I. key reasons why researchers do not make data for some studies 

publicly available have nothing to do with scientific quality. Further, as discussed below and in 

the Terminology section. while reanalyzing study results using the same data is one way to help 

validate those results. it is neither the primary nor a sufficient way to do so. Hence, EPA's 

apparent conflation of data availability and best available science is not based on any evidence 

cited by EPA, is contrary to the evidence before EPA, and is simply arbitrary. 

EPA's Preamble to the Integrated Science Assessments provides another discussion of 

how EPA evaluates study yuality. and similarly, docs not call out publicly available data: 

[Tjhe individual study quality is evaluated by considering the design, methods, conduct, 

and documentation of each study, but not the study results. This uniform approach aims 

to consider the strengths, limitations, and possible roles of chance, confounding, and 

other biases that may affect the interpretation of individual studies and the strength of 

inference from the results of the study. 313 

A statement by the American Statistical Association on p-Values: Context, Process, and 

Purpose further emphasizes the multiple considerations related to quality, stating "Researchers 

should bring many contextual factors into play to derive scientific inferences, including the 

design of a study, the quality of the measurements, the external evidence for the phenomenon 

under study, and the validity of assumptions that underlie the data analysis."334 Similarly. the 

letter filed by the Presidents of the National Academies of Sciences, Engineering, and Medicine 

in this docket lists multiple reports conducted since 2007 that have examined EPA's scientific 

assessment processes and "that advise EPA on the scientific bases of regulatory decisions related 

to human health and the environment."335 According to the NASEM Presidents, 

m EPA. Preamble to the Integrated Science Assessments at 7. 

https :/ /dbu b. epa. gov /ncea/isa/recordisplav .c fm 0 deid~ 3 l 0244. 

'"Ronald L.. Wasscrstcin & Nicole A. Lazar. The ASA 's Statement onp-Values: Context. Process and Purpose. 

70:2 The American Statistician 129, IJI (20!6). 

m Letter to Acting Administrator Wheeler fi·om Marcia McNutt. President ofthe National Academy of Sciences, 

C:.D. Mote. Jr., President of the National Academy of Engineering, and Victor .1. D7llU, President of the National 

Academy of Medicine 2 (July 16. 2018). 

73 
153 


33371.135

These reports encourage EPA to consider all available science in the rule-making process 

and provide guidance about how the agency could be more transparent in describing how 

evidence is gathered and evaluated .... Individual study quality should be evaluated on 

the basis of information that is available in standard journal articles, such as the study 

design elements, analytical techniques, and statistical methods. Researchers may be 

contacted to answer questions about the conduct of the study or be asked to provide 

additional data. If the study data are not available. their absence may affect how the study 

is rated and used in the analysis, but the study should not necessarily be e/iminated.fi·om 

the assessment. 336 

OMS's Guidelinesfor Ensuring and Ma~imizing the Quality, Objectivity, Utility, and 

Integrity of Information Disseminated by Federal Agencies provide another important example 

of the distinction between information transparency and quality. Unlike the Proposal, which 

conflates transparency with quality, OMS's Guidelines encourage transparency as a means to 

obtain greater objectivity in data, but do not consider it an absolute requirement or the only 

means by which objectivity can be achieved. The Guidelines specifically provide that it is 

possible to verify the objectivity of information that cannot be made publicly available through 

other types of"robustness checks."337 

As an example. the OMB Guidelines point to the Harvard Six Cities Study, where 

underlying data could not be made publicly available due to confidentiality concerns. In that 

case, the raw data was released only to researchers at the Health Effects Institute. who were 

bound to the same confidentiality requirements as the original researchers. and who were able to 

reanalyze and reproduce the study's results. 338 

c) Reanalyzing a study using publicly available data is not necessary 

to ensure valid science nor sufficient to ensure against invalid results. 

To ensure the validity of scientific research, the scientific community relies most heavily 

upon peer review. In peer review, independent scientists with related expertise evaluate a study's 

quality using the types of factors discussed above. Studies used by EPA are ofien further 

evaluated by one of EPA's scientific advisory boards, such as the Clean Air Science Advisory 

Committee or the Science Advisory Board. These types of reviews do not depend on a study's 

data being made publicly available. 

Making data available does allow independent researchers to try to reanalyze the same 

data and produce the same results. But reanalyzing a study is just one of many ways the 

scientific community ensures integrity. and it is not. in fact a widely used mechanism. 339 

Be !d (emphasis added). 337 OMS, Guidelinesfor Ensuring and Maximi::ing the Quality, Ohjecti1'ity, Utility. and Integrity qf information 

Disseminated hy Federal Agencies; llepuh!ication. 67 Fed. Reg. 8.452. 8.460 (Feb. 22. 2002) . 

. us !d. al 8.456. 

"'See John P.A. loannidis. All science should iliform policy and regulation. IS PLOS MeJ I. 2 (May 3. 2018). 

http://journals.pios.org/plosmedicine/article?id"" 10. 1371/joumal.pmed.l002576 (However. we should recognize that 

74 
154 


33371.136

Reproducing study results using a different population or method is generally considered a 

stronger validation than simply reanalyzing the results using the same data, as it shows that the 

results hold across a different population 340 

5. EPA arbitrarily attempts to bolster one element of scientific transparencv. 

while ignoring significant other transparency-related concerns. 

Another arbitrary aspect of this proposal is that EPA appears to assume that the only way 

to enhance transparency in regulatory science is to ensure that the underlying data and modeling 

for individual studies are publicly available. In fact, significant concerns have been raised about 

other non-public aspects of the modern scientific research and publication process that may 

undermine the accuracy of scientific results. For example, there are rising concerns about the 

increasing numbers of predatory pay-to-publish journals, which provide little-to-no guarantee of 

scientific integrity of their published studiesH1 Other areas of concern include undisclosed 

financial bias.341 But rather than evaluating concerns related to transparency across the spectrum 

of peer-reviewed science. EPA has arbitrarily seized upon one narrow area. This area also 

happens to be a target of regulated industries, as discussed further in Section VII. 

6. EPA's justification of the proposal is incoherent and lacks almost any 

evidentiary support. 

Although as discussed above. EPA has not identified a problem with EPA's use of 

science, EPA may be assuming (without any basis of support) that it needs to strengthen the 

validity ofthe science EPA uses in rulemaking. If so, EPA then appears to leap to the 

conclusions (again without any supporting evidence) that the only way to strengthen the validity 

of the science is by enhancing transparency, that no other possible steps to enhancing integrity 

are worth considering, and that enhancing transparency means making underlying data and 

models publicly available. This is all before EPA even gets to its obviously illogical conclusion 

most of the raw data ![·om past studies arc not publicly available. In a random sample of the biomedical literature 

(2000-2014). none of268 papers shared all of their raw data. Only one shared a full research protocol. The 

proportion of studies that have had all their raw data independently re-analyzed is prohably less than one in a 

thousand, The number of studies that have been exactly replicated in new investigations is quite larger, but still a 

n1inorily in most fields.") (citing Iqbal S, Wallach J, Khoury MJ, Schully S, Joannidis JPA .. Reproducible research 

practices and transparency across the biomedical literature, 14 PLoS Rio!. 1 (201Cl) (';Replication studies were rare 

(n 4). and only 16 studies had their data included in a suhsequent systematic review or meta-analysis.'')). 

J.:to See, e.g., Comments of the International Society for Environmental Epidemiology on EPA's proposed rule on 

Strengthening Transparency in Regulatory Science Section 2 (EPA-HQ-OA20 18-0259-000 I). 

https:/lwww.regulations.gov/document?D=EPA-HQ-OA-2018-0259-1973 ("However, although data reanalysis has 

a role to play. ultimately. the key determination of the consistency of scientific evidence comes from replication. nol 

rcanaly:;is.") (note that I SEE uses the term "replicate" to mean what \Ve have defined in these comments as 

.. reproduce .. ). 

34 ! See Gina Ko!Jta. ~\!any Academics are Eager to Publish in Worthless Journals. N.Y. Times (Oct. 30, 20 17). 

https:/lwww.nytimes.com/20 17/1 0/30/science/predatory-iournals-academics.html; Publish and Don't Be Damned. 

The Economist (June 23. 20 18), https:llwww.economist.com/science-and-technologv/20 18/06/23/some-sciencejourna!s-that-claim-to-pccr-rcview-papcrs-do-not-do-so. 

·' 12 EPA. Scientific Integrity Policy. https://www.epa.gov/sites/production/liles/20 14-

02/documents/scientific integrity policy 2012.pdf(sceking to protect agency reliance on science fi·om political 

interference. personal motivations. conflicts of interest. bias. etc.). 

75 
155 


33371.137

that threatening exclusion of studies without publicly available data will "increase access to dose 

response data and models underlying pivotal regulatory science," 343 rather than simply bar EPA 

from considering a vast universe of useful and rigorously vetted studies. The evidence cited by 

EPA in suppot1 of the need to strengthen science through its proposed approach is so vague and 

perfunctory that it is largely impossible even to tell which conclusions various sources are 

supposed to support. EPA's rationale for its data availability requirements consists of a few 

conclusory statements by EPA itself, a reference to "the replication crisis," and citations to a 

handful of articles and guidance issued by EPA and OMB. None of these provide a rational basis 

of support for the Proposal. 

EPA begins by stating that the "proposed rule is consistent with the principles underlying 

the Administrative Procedure Act and programmatic statutes that EPA administers to disclose to 

the public the bases for agency rules and to rationally execute and adequately explain agency 

actions.'' 344 While EPA is correct that it must disclose the basis and provide an adequate 

explanation for rulemaking (principles EPA manifestly fails to follow in this Proposal), it does 

not follow that these principles either require or support the quite specific notion that dose 

response data and models must be publicly available. Nor does EPA attempt to explain how 

these broadest of rulemaking principles support EPA's specific proposed approach here. 

Next. EPA states that the proposal is ''consistent with" two recent executive orders and 

OMB guidelines on information quality and agency information management. 345 One of the 

executive orders says nothing more than that environmental regulations should be ·'developed 

through transparent processes that employ the best available peer-reviewed science .... "346 The 

other is targeted at eliminating regulations including those that are "unnecessary" and 

"ineffective," which, as our comments detail. the Proposal clearly would bc 347 While the OMB 

guidelines on information quality generally support transparency in science. they call for a far 

more nuanced approach than EPA proposes here and do not call for agencies to exclude studies 

for which underlying data is not available, as discussed above in section I. C. In fact, as discussed 

above, EPA's proposal unlawfully contravenes these guidelines. 

EPA then states that the Proposal "builds upon" prior EPA actions in response to 

government-wide data access and sharing policies. 348 In support of this claim, EPA cites 

generally to five prior EPA policy documents related to science. EPA fitils to point to a single 

statement, provision or requirement in any of these documents, however, as support for the 

specific approach proposed here. This is not surprising. as EPA's proposal to exclude studies 

with non-public data is actually a significant change from the prior policies, which supported 

balancing the interest in access to data with interests in privacy and confidentiality. as discussed 

in more detail in Section !I.E. In fact, one ofthe documents cited by EPA, the Plan to Increase 

Access to Results of EPA-Funded Scientific Research, directly contradicts an apparent premise of 

m 83 Fed. Reg. at 18.770. 

-'" 83 Fed. Reg. a\ 18.769. 

3-15/d. 

.1·'6 Exec. Order No. 13.783. 82 Fed. Reg. 16,093, 16.093 (Mar. 31. 20 17): see also discussion in Appendix A. 

Exec. Order No. 13777.82 Fed. Reg. 12285. 12286 (Mar. I. 2017): see also discussion in Appendix A. 

" 8 83 Fed. Reg. at 18.770. 

76 
156 


33371.138

EPA's Proposal, stating: "Whether research data are fully available to the public or available to 

researchers through other means does not affect the validity of the scientific conclusions from 

peer-reviewed research publications."349 EPA ignores this contradiction altogether and provides 

no explanation whatsoever as to how the Proposal "applies concepts and lessons learned from 

[EPA's] ongoing implementation" of this plan, as EPA asserts. 350 

EPA also claims that the Proposal builds on the "experience of other federal agencies in 

this space."351 In this case, EPA simply lists other federal agencies without referring to any 

policies, documents or actions by those agencies, except for one particular Census Bureau 

database that allows federal Census data to be shared securely. Obviously a bald uncited 

statement that other federal agencies have ·'experience in this space" is far too vague to allow 

meaningful comment by the public on EPA's rationale for its action, much less provide any 

support or rationale for the proposed policy. Further, the Census Bureau database cited is an 

example of how an agency can provide secure access to its own data, but it does nothing to 

explain or justify EPA's Proposal to exclude third party studies with nonpublic data from 

consideration in rulemaking. The U.S. Census Bureau operates the Federal Statistical Research 

Data Centers, which are secure facilities providing authorized access to restricted-use microdata 

for statistical purposes only. To gain access, researchers must obtain Census Bureau Special 

Sworn Status-passing a moderate risk background check and swearing to protect respondent 

confidentiality for life. This approach meets the U.S. Census Bureau's needs by allowing access 

to confidential information only to researchers whose proposals meet certain criteria, who go 

through a vetting process, and who agree to protect the information. Yet again, this is a structure 

designed to protect data collected by the government, not third parties, and there are substantial 

costs to this approach, which are borne by the Census Bureau. It is clearly not directly 

transferable to the context of the Proposal. 352 It is also unclear whether such a structure, even if 

it were practical (which it is not), would be sufficient to satisfy EPA's requirement to make data 

and models ··publicly available:· 

Next, EPA vaguely refers to recommendations from third party advocates supporting 

·'open science."353 EPA does not specify. let alone discuss, those recommendations. EPA 

certainly does not explain how EPA's current use of science is inconsistent with any such 

recommendations or inadequate in light of them, or whether any of these third party 

organizations believe that studies with non public data are insufficiently valid for use in 

rulemaking. Indeed, one of the organizations cited by EPA-the Bipartisan Policy Center 

" 9 EPA. Plan to Increase Access to Results of EPA-Funded Scientific Research 4-5 (20 16) (emphasis omitted). 

https://www .ena.gov/sites/production/ti le.s/20 16~ 12/documents/epascienti ficrescarchtransperancyplan.pdf. 

Jso 83 Feel. Reg. at 18.770. 

351/d. 

352 See Letter to Acting Administrator Wheeler from Marcia McNutt President of the National Academy of 

Sciences. C.D. Mote, Jr .. President of the National Academy of Engineering. and Victor J. Dzau. President of the 

National Academy of Medicine 3 (July 16. 2018). (''There are several differences in the confidential microdata 

collected ti·om individuals and businesses by federal statistical agencies through surveys. versus data and results 

tl·om the kinds of studies that are within the scope ofthc EPA proposed rule. These differences have important 

implications about making data publicly accessible. What works well in the federal statistical environment may not 

translate effectively to EPA. where stakeholders might be strongly motivated to discount stlldy results that run 

counter to their regulatory preferences.''). 

m X3 Fed. Reg. at 18770. 

77 
157 


33371.139

("BPC")-filed a letter in this docket stating emphatically that "the proposed rule is not 

consistent with the BPC report in substance or intent. While the Science for Policy Project panel 

encouraged greater transparency and access to data, the report never suggested excluding studies 

from consideration in developing regulation if data from those studies were not publicly 

available.''354 Again, the policy documents cited in the footnote accompanying this statement 

generally undercut rather than support EPA's ProposaL as discussed in detail in Appendix A. 

EPA also suggests that "these policies" (which policies it is unclear) ''are informed by the 

policies recently adopted by some major scientific journals." 355 EPA does not cite any specific 

policies adopted by the journals named in the footnote, but it does not appear that any of those 

journals has determined that studies with nonpublic data arc invalid and should not be relied 

upon or used. To the contrary, the editors of these journals issued a strong public statement 

aftlrming that "in not every case can all data be fully shared," that "the merits of studies relying 

on data that cannot be made publicly available can still be judged," and that "[i]t does not 

strengthen policies based on scientific evidence to limit the scientific evidence that can inform 

them ... Excluding relevant studies simply because they do not meet rigorous transparency 

standards will adversely affect decision-making processes.''356 Again, however, EPA's failure to 

provide any specific information or citations in support of its conclusory statements make it 

impossible to meaningfully comment on the support for EPA's ProposaL 

Further, EPA mentions "the replication crisis,'' 357 but provides no information on the 

reality, seriousness, scope, implications, or causes of such a crisis. EPA fails to explain what it 

understands the ''replication crisis'' to be. much less how EPA's proposal might ameliorate it. It 

is not even clear whether EPA understands the meaning of the term "replication,'' as the agency 

fails to distinguish between "rcplicability" and ''reproducibility," and uses both terms apparently 

interchangcably. 358 See earlier discussion of key terminology at page 9. 

The proposed regulatory text provides, "[i]nformation is considered 'publicly available in 

a manner sufftcient for independent validation' when it include the information necessary for the 

public to understand, assess, and replicate findings" and then lists ''data'' as the first type of 

information that may be included.m Yet "replicating findings" is essentially limited to 

laboratory animal and randomized controlled trials and does not capture the vast majority of 

human epidemiological studies. More importantly, replicating studies does not require access to 

underlying study data, but rather details regarding the methodological design. Further 

"reproducing" studies is generally viewed as a more informative and resource efficient approach 

to validation of research. 

15' Leiter ti·om Jason Grumct. President ofBPC to Administrator Scott Pruitt (May 22. 201 ~). 

355Jd 

350 Jeremy Berget a!.. Joint state men! on EPA proposed rule and public availability c?f dnla. Sdence (Apr. 30, 

201 X) . 

.157/d. 

Js& Compare, e.g .. 83 Fed. Reg. at 1~774 (proposed rule requires information to be available "l(Jr the public to 

understand. assess. and replicate findings"), and 83 Fed. Reg. at 18770 (alluding to "replication crisis" as a basis lor 

the need for the proposed rule). with 83 Fed. Reg. at I ~772 (discussing an analysis purporting net benefits trom the 

proposal due to "greater reproducibility"). and 83 Fed. Reg. at I ~769 ("EPA must. .. ensure that its decision-making 

is marked by independence, objectivity, transparency. clarity, and reproducibility."). 75" 83 Fed. Reg. at 18773-74 (emphasis added). 

78 
158 


33371.140

finally. to the extent that specific circumstances justif; actually replicating a study, foP A 

tails to explain why it is nect)ssary to make a study's underlying data broadly available to the 

public rather than employing a more secure approach that protects personal privacy. For 

example, to quell concerns about the validity of the American Cancer Society Cancer Prevention 

Study ll (ACS CPS II) and the Harvard Six Cities Study-both seminal air pollution studies that 

are described earlier in these comments-an independent panel of Canadian and American 

scientists independently audited and reanalyzed them. Due to personal privacy concerns, the data 

was not made publicly available but was instead held in a restricted access data warehouse at 

the Health Effects Institute, an organization funded by both the automotive industry and EPA. 

The independent audit and reanalysis took three years and roughly one million dollars. It 

evaluated the consistency and accuracy of the data and then undertook a series of comprehensive 

analyses to test the robustness of the original findings and interpretations to alternative analytic 

approaches. The results of the independent analysis found resoundingly similar results tor both 

studies.360 

The results of this reanalysis suggest that routine assessment of quality indicators such as 

methodology. cont(Junding and bias routinely evaluated in the peer review process are generally 

su!Iicient to confirm a study's validity. Fu11hcr. while it plainly would be infeasible to undertake 

such an expensive and time-consuming reanalysis fl1r the vast mt~jority of studies. this example 

demonstrates that it is possible to undertake a reanalysis without making underlying data broad I; 

available to the entire public. Yet EPA's proposed rule apparently would bar regulators from 

relying on these high quality and extensively vetted studies due to the fact that the underlying 

data was never made publicly available. EPA does not-and cannot--explain how a rule that 

would prohibit the agency tl-om considering these seminal. high quality scientific studies 

comports with its goal of strengthening the agency's usc of science in regulatory actions. 

7. EPA has failed to explain why it has singled out dose response studies to 

be excluded if their underlying data and models are not publiclv available, but has 

not similarly targeted anv other types of studies commonly used by EPA. 

EPA also has proposed to target the requirements for public availability specifically to 

the data and modeling underlying one specific subset of scientific research--dose response 

studies. EPA has provided no explanation or justification tor targeting dose response studies in 

particular or for not including other types of studies or scientific information. EPA has not 

suggested that these studies are inherently less reliable than other studies. that they more 

36° For the Harvard Six cities study. the reanalysis results were I .28 hazard ratio for mortality per 18.6 microgram 

per meter cube of PM2.5. in comparison to a hazard ratio of 1.26 found in the original study. For the ACS CPS II 

study, the reanalysis showed that for every 25.4 microgram per meter cube change in PM2.5 there was an associated 

hazard ratio tor mottality of !.18 (resuiL' of the independent reanalysis). as compared to the hazard Ratio of !.17 

reported by the original investigators. Daniel Kre\vski, et al.~ Overview of the reanalysis a,[ the Harvard six cities 

study and American Cancer Society study of particulate air pollution and mortality, 66 J. Toxicology & Envtl. 

Health Part A }j07 (2003): llealth Effects lnst.. Reanalysis of the Harvard Six Cities Study and the American 

Cancer Society Study of Particulate Air Pollution and Mortality (2000 ). 

79 
159 


33371.141

commonly fail to publicly disclose data and modeling information, that replication is more 

necessary for these studies than others, or any other conceivable reason. Absent any explanation 

from the agency, it is impossible to comment on the factual predicates for EPA's proposed 

decision, or the reasonableness ofEPA'sjustification, except to state that it appears completely 

arbitrary in the absence of any rationale. See, e.g., Transactive Corp., v. United States, 91 FJd 

232, 237 (D.C. Cir. 1996) ("A long line of precedent has established that an agency action is 

arbitrary when the agency offered insufficient reasons for treating similar situations 

differently.''). 

8. EPA arbitrarily failed to consider the implications of this proposal on 

interagency coordination. 

Additionally, EPA arbitrarily failed to consider the far-reaching implications this 

Proposal could have on inter-agency coordination and consultation given that other agencies 

normally rely on research potentially excluded by the Proposal. 361 In the numerous 

environmental statutes that EPA cites, there are dozens of provisions that require EPA to 

coordinate or consult with other Federal entities-especially when implementing research 

programs and issuing information or guidelines. 362 The Proposal would almost certainly frustrate 

and impair this coordination and consultation, either by forcing EPA to ignore the science 

provided by other agencies or by severely restricting the science that EPA itself would be able to 

share with other agencies in these statutorily required processes. The Proposal arbitrarily ignores 

these potential impacts. 

In addition to the many examples of statutorily required consultation that are identified in 

Appendix B, other federal agencies routinely incorporate and rely upon EPA science assessments 

in their own efforts to carry out their mandates to protect human health and safety. As with 

statutorily required consultations. the Proposal utterly fails to acknowledge or consider what 

impacts restricting EPA's own use of dose-response studies would have on the work of these 

other agencies. Indeed, there is no evidence that these other agencies were even permitted to 

comment on the Proposal as part of the usual process of interagency review. 

Some selected examples of other federal agency programs that rely on EPA science 

include: 

The Food and Drug Administration (FDA) enforces tolerances established by EPA for 

pesticide chemical residues in human and animal foods under the Federal Insecticide, 

J6l See Motor Vehicle Mfrs. Ass'n v. Stale Farm Mut. Auto. Ins. Co., 463 U.S. 29. 43 (1983) ("Normally, an agency 

rule would be arbitrary and capricious irthe agency has ... entirely failed to consider an important aspect of the 

problem."). 

'"2 Sec 42 U.S.C. ~~ 7403. 7408(a). 7408(c). 7408(f). 74!2 (Clean Air Act§§ 103. 108. 112); 33 U.S.C. §§ 13!4. 

13!7(al(7). l345(d)( 1) (Clean Water Act §§ 304, 307(a)(7). 404(d)( I)): 42 U.S.C. §§ 6907(a). 6911, 6912(a)(2)-(6 ), 

6942(b). 6981(a) (Resource Conservation and Recovery Act§§ lll08(a). 2001. 2002(a)(2)-(6). 4002(b). 8001(a)J: 7 

U.S.C. ~§ 136w-3. 136w(d). 136a-l(n)(2)-(3). 136(11)(2). !36t(b), 136i-2(c) (Federal Insecticide. Fungicide. and 

Rodenticide Act§~ 2. 4. 11. 22. 25, 28); 15 U.S.C. §§ 2608id). 2604(1)(5). 2604(hl(2)(BJ(ii) (Toxic Substances 

Control Act): 42 U.S.C. § 301lg-1 (b)( I l(D). 300g-li d). 300j-l3(a)(5). 300j-3d. 300j-19i b)(2)(A l (Safe Water 

Drinking Act). See also Appendix 8: Table of Consultation Requirements. 

80 
160 


33371.142

Fungicide, and Rodenticide Act, including through a comprehensive pesticide residue 

monitoring program that tests for approximately 700 pesticide residues in both impotted 

and domestic commodities 363 To the extent the Proposal affects EPA's tolerances, the 

nature and effectiveness of FDA's own work to monitor for violations of those 

tolerances would be impacted. 

FDA also regulates contaminants in bottled water under the Federal Food, Drug and 

Cosmetics Act. Section 410 of the Act requires that FDA regulations for bottled water 

be issued in coordination with the effective date of National Primary Drinking Water 

Regulations issued under the Safe Drinking Water Act, and be no less protective of 

public health than those standards. If the Proposal impedes EPA's work to establish 

drinking water standards, this may affect FDA's own ability to justify protective bottled 

water standards.364 

In certain circumstances, FDA also coordinates with EPA to provide the public with 

information and advice on environmental contaminants in foods. For example, in 2017 

FDA and EPA released a joint advisory on mercury hazards associated with the 

consumption of fish and shellfish, which was based in part on EPA's assessment of the 

"reference dose" or level of exposure that a person can experience over a lifetime 

without a risk of harm. 365 The Proposal could radically alter the science EPA would be 

permitted to consider in future such initiatives, and frustrate the ability of FDA and other 

agencies to coordinate effectively with EPA to develop joint advice and information. 

The Department of !lousing and Urban Development is required by statute to assist EPA 

in assessing the extent of radon contamination in the United States and developing 

measures to avoid and reduce radon contamination.366 I-IUD has also developed policies 

to require radon testing at properties receiving federal financing, which incorporate EPA 

radon standards.367 To the extent the Proposal affects future EPA assessments of radon 

risks, the scope, cost and effectiveness of HUD radon programs could be affected as 

well. 

9. EPA's proposal irrationallv excludes proceedings that tend to benefit 

industry interests, even though these proceedings are far less transparent than the 

rulemakings EPA has targeted. 

EPA's claims that it values transparency are clearly a pretext for eliminating 

"inconvenient," life-saving science from rulemakings that increase public health protection. 

Among other things, by excluding adjudications, permit proceedings, and certain rulemakings, 

EPA has excluded proceedings where EPA and industry regularly rely on nondisclosed 

information and where agency action in general, and particularly expeditious action, tends to 

"('3 FDA. Pesticide Residue itfonitoring Program Questions and Answers, 

hllps://wwwfda,gm•IFoodFoodborne!llnessContaminants/PesticidesiuCm5837 1 l.htm {last visited Aug. 13. 2018). 

''"FDA. Guidance(or Indus/!)" Bottled Waler and To/a/ Coliform and E. Coli: Small Enlily Compliance Guide, 

h!!ns: iilt'ww. fda gor/Food'Ciuidance f?egl.tlation,cGuidance DocumentsRegulatorv!nformation/ucm2()6215. htm (last 

visited Aug. 14. 2018). 365 Advice About Eating Fish. From the Environmental Protection Agency and Food and Drug Administration: 

Revised Fish Advice; Availability. 82 Fed. Reg. 6572 (Jan. 19. 2017). 

"'"See Pub. L. 100-628. title X.§ 1091. Nov, 7.1988,102 Stat. 3283, 767 See HUD. HUD Oftice of Multifamily Development Radon Policy. Notice H 2013-03 (Jan. 31. 2013). available 

at ht1ps: ·nvwwhudgm'<'\iTes:documems,'/3-0JHSGi'v'.PDF. 

81 
161 


33371.143

favor industry. By limiting the proposal to "significant regulatory actions," the proposed rule 

would treat exactly the same study differently depending on whether it supports regulation or 

non-regulation in a particular context. The proposed rule will tend to exclude evidence when it 

supports a health-protective regulation that is costly to industry, but the proposed rule will then 

allow the use of the exact same evidence when the ultimate agency decision avoids regulation or 

deregulates industry activities or otherwise has low compliance costs. Thus, the Proposal is 

clearly shaped to favor industry interests, not to further transparency. 

Specifically, EPA has chosen to limit the application of this Proposal to "significant 

regulatory actions'' under E.O. 12866, and thus EPA does not extend this Proposal to 

adjudications, permit proceedings, or many less economically significant rulemakings. 368 In 

particular, EPA has effectively exempted the TSCA new chemicals program where industry 

seeks expeditious actions allowing market access and EPA regularly fails to disclose its own 

analyses and the studies and materials supporting those decisions, much less any underlying data. 

As explained below, in these proceedings industry seeks affirmative authorization from EPA to 

commercialize chemicals, so industry has a vested interest in expeditious government action. 

EPA's decision to exempt these proceedings is particularly egregious because these 

proceedings are extraordinarily more opaque than the rulemakings EPA has targeted with this 

Proposal. In the TSCA new chemicals program, EPA often provides no meaningful opportunity 

for public review or comment before EPA takes action, and EPA regularly violates its existing 

statutory and regulatory obligations by disclosing almost none of its analyses or the information 

supporting its decisions to authorize the manufacture of new chemicals. Notably, much of the 

information at issue has never been peer-reviewed or subjected to nearly the level of public 

scrutiny as have the studies that EPA is trying to exclude from health-protective rulemakings 

under the proposed rule. EPA cannot credibly claim to pursue transparency with this Proposal 

while running certain programs as "black boxes'' where little, if any, information is disclosed. ·ro 

be clear. the problem is that EPA often does not disclose its own analyses or many of the 

underlying studies at all, much less underlying data; it is outrageous for EPA to then turn around 

and suggest that, in other contexts, disclosure of its analyses and the supporting peer-reviewed 

studies provides insufficient transparency. 

As drafted, EPA's Proposal will not apply to EPA's New Chemicals Review Program 

under TSCA. TSCA § 5 governs EPA's review of"new chemical substance[s]," generally 

chemicals that have not previously been distributed in U.S. commerce. 369 By and large, no 

person may manufacture (defined to include import) a ''new chemical substance" in the United 

States without providing EPA notice at least 90 days beforehand. 3711 When a person submits a 

pre-manufacture notice (PMN). EPA must review the PMN and make one of three types of 

determinations under TSCA § 5(a)(3).371 EPA then must take the actions required by the 

'''' 83 Fed. Reg. at 18.771. 

1C·' See !5 U.S.C. ~* 2604. 2602(1!). 

ld § 2604(a)( I). 

/d § 2604(a )(I )(ll ). Depending on the circumstances. instead of submitting a PMN. a person may seek to obtain 

one of several exemptions from the PMN process. such as the Test Marketing Exemption. The proceedings 

governing npplications f()r these exemptions involve even less public disclosure than EPA ·s processing of 

PMNs. EPA's proposal will also not apply to the proceedings governing these exemptions. 

82 
162 


33371.144

relevant determination, and the person must comply with any applicable requirement imposed.372 

The person may not begin manufacturing the chemical substance until EPA has completed its 

review and made a determination. These proceedings do not qualify as significant regulatory 

actions under E.O. 12866, because EPA does not consider them rulemakings and because the 

regulation of chemicals that have not yet been introduced to the market generally will not be 

economically significant within the meaning of the E.O. 

Because industry generally cannot manufacture a new chemical substance until EPA has 

completed its review, industry has a strong interest in expeditious action on PMNs. Nor is this 

idle speculation; industry commenters have repeatedly called for EPA to move more 

expeditiously. 373 Providing disclosure in these proceedings would likely, at a minimum, take 

additional time, and thus it seems likely that EPA has exempted these proceedings to serve 

industry's interest in hasty resolution. 

Moreover, the New Chemicals Program is infinitely more opaque than the rulemakings 

EPA is currently targeting with its Proposal, often in direct violation of law. EPA does not make 

the public files for new chemicals electronically available, and when a person does obtain a copy 

ofthe public file from EPA, 374 the files generally reveal almost none of EPA's analyses 

supporting its decisions or the information submitted to support those decisions, with massive 

amounts of data redacted or concealed as Confidential Business Information (Cill). It's not a 

question of failing to disclose all the underlying data; EPA often fails to disclose the supporting 

studies or information at all. 

'" ld 37 ·-, See, e.g. Am. Coatings Ass'n Comment on New Chemicals Rcvicv,.r Program 2 (Jan. 20201 8). 

https://www.regulations.gov/document?D~EPA-HQ-OPPT-20l7-05R5-0068 (""We urge the Agency to expedite the 

process as much as possible. so that manufacturing is able to commence."), Docket ID: FPA-HQ-OPPT-2017-0585-

0068: Am. Chemistry Council Comment on New Chemicals Review Program 7 (.ian. 19.20 18). 

hllps://www.regulations.gov/document?D•FP A-110-0PPT -20 17-0585-0062 ("These delays underscore industry's 

continuing concerns that the section 5 program remains too slow .... "). Docket ID: EPA-HQ-OPPT-2017-0585-

0062: U.S. Chamber of Commerce Comment on New Chemicals Review Program 3 (Jan. 19. 2018). 

https://mvw.regulations.gov/document?O~EPA-HQ-OPPT-2017-0585-0057 ("[T]he Chamber believes that EPA 

should continue to strive to meet the 90~day goa! in a timelier and more effective fashion ... .''), Docket ID: EPAIIQ-OPPT -2017-0585-0057: Am. Petrol. lnst. Comment on New Chemicals Review Program 2 (Jan. 19. 2018). 

https://\yww.reE:ulation.s.gov/document?D=EPA-HQ-OPPT-2017-0585-0053 ("EPA should respond to a request for 

a Pre-Notice Consultation in a .short tirncth1me-two to four days. rather than two to four vveeks."). Docket !D: 

EPA-HQ-OPPT-2017-05X5-0053: In!' I Fragrance Ass'n N. Am. Comment on New Chemicals Review Program I 

(Jan. 20. 2018). https://www.regulations.gov/document0 D4iPA-IIQ-OPPT-2017-0585-0064 (identifying as a 

problem "review periods far exceeding 90 days- some exceeding a year"), Docket!D: EPA-HQ-OPPT-20 17-0585-

0064. 

As EDF has previously explained. EPA is already committing systematic procedural violations by tailing to make 

the public tiles tor new chemicals electronically available to the general public. Envtl. Dcf. Fund Comment on New 

Chemicals Review Program 23-26 (.I an. 20, 20 18). https://www.regulations.gov/doeument?D~FPA-HO-OPPT20 17-0585-0071, Docket ID: EPA-HQ-OPPT-20 17-0585-0071. Under TSCA g 5( d). each Prc-manutacturc Notice 

(PMN) "shall be made available. subject to section 14. tor examination by interested persons." 15 U.S.C. 

g 2604(d)( I). EPA's implementing regulations provide that ''fall! information submitted with a notice. including 

any health and safety study and other supporting documentation. will become part of the public file tor that notice," 

40 C.F.R. g 720.95. and those public tiles are supposed to be "available in the electronic docket at 

http://www.regulations.gov." !d. g 700.17(b)( I). Rut EPA generally does not make the public tiles l(lr PMNs 

electronically available. 

83 
163 


33371.145

As EDF detailed in prior comments and in various blog posts, EPA regularly conceals 

vast swathes of information in this program, including providing many blank documents 

identified as consisting of health and safety studies.375 Notably, in this same context, industry 

commenters have urged EPA to take steps to accept data and information that will not be 

publicly disclosed or where EPA will only be provided with or make public industry-prepared 

summaries of the underlying data. See, e.g., Comment submitted by Raleigh Davis, Assistant 

Direction, EHS, American Coatings Association (ACA), 

https://www.regu lations.gov/document?D=EPA-HQ-OPPT -2017-0585-0068 ("ACA strongly 

encourages EPA to develop as many of these [non-disclosure agreements] as possible."); 

Comment submitted by Jared Rothstein, Senior Manager, Regulatory Affairs, Society of 

Chemical Manufacturers & Affiliates (SOCMA), p.l 

https:/ /www.regu lations.gov/document?D=EPA-HQ-OPPT -2017-0585-0049 ("EPA should 

accept the submission of robust summaries."). Thus. industry has expressed a desire tor EPA to 

continue to operate the new chemicals program with limited disclosure, and thus far, EPA has 

acceded to that wish. 

If EPA extended the rule articulated in proposed § 30.5 to the new chemicals program. it 

would seem that EPA would either have to make much of the information in the public tiles 

available or EPA would be precluded from using this information. 83 Fed. Reg. at 18.769 n.3 

(stating that EPA is proposing to preclude itself from using such data in future regulatory 

actions). Without this information, EPA generally would not be able to lind that the new 

chemical "is not likely to present an unreasonable risk of injury to health or the environment," 

the finding that allows unregulated manufacture of the chemical. See 15 U.S.C. § 2604(a)(3)(C). 

Notably, TSCA expressly provides a resolution when EPA has insufficient information, 

requiring that EPA regulate the chemicai.Jd. § 2604(a)(3)(B)(i), (e). When "the information 

available to [EPA] is insufficient to permit a reasoned evaluation of the health and environmental 

effects of the relevant chemical substance; ... [EPA] shall issue an order" regulating the 

chemical "to the extent necessary to protect against an unreasonable risk of injury to health or the 

environment." ld. 2604(e).Thus, excluding the information would require EPA to regulate the 

new chemicals before they could enter the market. 

Thus. EPA's exclusion of the new chemicals program clearly favors industry. allowing 

industry to conceal information and evade regulation. In addition, EPA cannot rationally impose 

stringent new disclosure requirements that exclude extensive peer-reviewed, high-quality studies 

in some contexts while simultaneously authorizing the commercial distribution of new chemicals 

with almost no disclosure and no peer-review. 

375 Envtl. Def. Fund Comment on New Chemicals Review Program 24·25. 

https://www.rcgulations.gov/document D~EPA-f!O·OPPT·2017·0585·0071. For more detaiL see EDF's series of 

blog posts on its finding in its our review of public tiles for nearly 70 new chemicals tc1r which EPA made "not 

likely to present em unreasonable risk'' determinations. Eg.. Stephanie Sch\vartz & Richard Dennison, EPA's 

Appalling Failure lo Provide Public Access 10 Public Dala on TSC4 New Chemicals. EDF Health Blog (Jan. 

24.20 18 ), http://bJogs.cd f'.org/heallh/20 18/0 1/24/epas-appal!ing·failure·tO·provide-pubJic-access-to-public-Jata-Ontsca-new-chem i ca Is/. 

84 
164 


33371.146

E. EPA's Proposal is Arbitrary Because it is Inconsistent With Long-Standing 

EPA and Federal Government Policies and Ongoing Efforts to Strengthen Science 

Quality in a Measured and Balanced Way through EPA's Existing Science Policies. 

EPA claims throughout the Proposal that it is consistent with EPA and other federal 

government policies and approaches to transparency. However, a closer look reveals that the 

documents that EPA itself cites do not support the over-simplified and drastic approach taken by 

the Proposal. Federal government policies to promote data transparency have instead advocated a 

careful approach that balances the benefits of data disclosure with the costs and risks associated 

with it. Nowhere do they suggest that confidential information that cannot be made public is no 

longer valid for agency use. Instead, they aim to maximize the integrity and usability of data 

through data sharing when possible and practical-to enhance rather than hinder the ability of 

government agencies to achieve their missions. The Proposal is based on unsubstantiated claims 

that lack evidence, deviates from existing EPA and broader federal government policy without 

acknowledgement or explanation, and conflicts with leading research and policy proposals in this 

area- rendering the Proposal arbitrary and capricious. 

Agencies are required to justify reversals in policy by addressing the existing record and 

reasons for why a change in policy is appropriate. 376 They must acknowledge the change and 

''show that there are good reasons for the new policy."377 The agency must supply a reasoned 

analysis beyond which would be required in the absence of the old policy. 378 An agency may not 

''disregard contrary or inconvenient factual determinations that it made in the past."379 EPA in 

the past took the position that: 

[EPA] does not believe that it is appropriate to refuse to consider published studies in the 

absence of underlying data. The EPA frequently relies on peer reviewed studies in the 

public literature across agency programs without possessing underlying data and the 

Federal courts have made clear that the EPA is not required to obtain or analyze the raw 

data in order to rely on such studies. If the EPA and other governmental agencies could 

not rely on published studies without conducting independent analyses of the raw data 

underlying them, then much relevant scientific information would become unavailable 

for use in setting standards to protect public health and the cnvironment.380 

'

76 FCC\'. Fox Television Stations. Inc. 556 U.S. 502. 5!5 (2009). 

ld 178 Motor Vehicle A{(rs. Ass 'n 1'. Stale Farm Mul. Auto. Ins. Co<> 463 U.S. 29. 42 ( 1983) ("[A]n agency changing its 

course by rescinding a rule is obligated to supply a reasoned analysis !()!'the change beyond that which may be 

required \Vhen an agency does not act in the first instance''). 379 FCC r. Fox Te/erision Stations. Inc. 556 U.S. 502. 537 (2009) (Kennedy. J. concurring). 380 House of Representatives. Committee on Agriculture. Hearing to Consider the !mpacls of the Environmental 

Protect;on Agency's A cOons on the Rural Economy Serial No. 114-41. 82 (Feb. II. 20 16) (response to questions 

from Gina McCarthy. Administrator. EPA): See also Email ti·om Nancy Reck to Justin Schwab and Richard 

Yamada (Mar. 5. 20!8. 1:42:01 AM) (part ofFOIA release to request by Union of Concerned Scientists citing EPA 

pesticide program documents from December 2016) (email tlags language from EPA pesticide program documents: 

·'To be dear. EPA continues to believe that the ra\.V data should be made available tOr public inspection to ensure 

that EPA ·s assessments are as transparent as possible. While the EPA therefore strives to ensure that data underlying 

research it relics upon arc accessible to the extent possible. it docs not believe that it is aprropriatc to refuse to 

consider rublished studies in the absence of underlying data. The EPA fl·equently relics on reer reviewed studies in 

85 
165 


33371.147

Thus, EPA in the past set forth a view diametrically opposed to the one it ·is taking now-in the 

past relying heavily on studies it would now be excluded from using. EPA previously recognized 

that there are other ways to validate scientific studies, such as through peer review, that do not 

require release of underlying data and its prior view rightly saw the danger in adopting a policy 

that would require EPA to make public underlying data. 

EPA's current policies set forth standards of scientific integrity that involve use of the 

best scientific information available (see 11.0.2), which the Proposal also now re-writes. While 

previously EPA took the view that all valid science (with proper quality control and assessment 

measures in place) should be considered as it sets standards, EPA now takes the position that it is 

more important to use only those studies where the underlying data and models are made 

available to the public, even if this compromises EPA's ability to use the best available science. 

EPA's existing open data policies recognize with exceptions and exemptions that as much as the 

pursuit of making data public is a worthy goal, there are competing interests. EPA has always 

taken the view that not releasing certain kinds of data to uphold these competing interests does 

not in fact compromise its scientific integrity or commitment to transparency-and the balance it 

strikes is the one most suitable to help its achieve its greater mission. The Proposal is arbitrary 

because EPA does not even acknowledge that it is now changing its view drastically and does 

not address the valid reasons underlying its prior policies or explain why they now merit 

changing. 

I. Instead of providing a reasoned explanation for its change in policy. EPA 

wrongfully claims the Proposal is consistent with existing EPA, federal 

government, and third-party practices and policies. 

As discussed further below in Section Vlii.D. the footnotes of EPA's Proposal in many 

cases provide only vague references to policies and reports that purportedly support the Proposal, 

leaving the public to guess as to what EPA is reterring and embark on a treasure hunt tor the 

relevant item. But even where EPA provides specific citations, examination quickly reveals that 

frequently they do not fully support the propositions they accompany, and, when viewed in full 

context, provide evidence against the Proposal. Because EPA makes a series of conclusory 

statements provided with no explanation or reasoning that would help the reader understand why 

EPA interpreted the cited record to support the Proposal, the Proposal appears to be completely 

unsupported by evidence and explanation-rendering it arbitrary and capricious. A full 

documentation of the misrepresentations made in the footnotes of the Proposal is available in 

Appendix A and demonstrates that EPA is not able to substantiate its claims that the Proposal has 

been informed by or is consistent with the policies of EPA, other agencies, or other 

organizations. 

the puhlic literature across agency programs without possessing underlying data and the federal courts (see Coalition 

of Battery Recyclers Association v. EPA. 604 F.Jd 613 (D.C. Cir. 2010); American Trucking Associations v. EPA, 

203 F.Jd 355 (D.C. Cir. 2002)) have made clear that EPA is not required to obtain or analyze the raw data in order 

to rely on such studies. If EPA and other governmental agencies could not rely on publisbed studies \Vithout 

conducting an independent analysis of the raw data underlying them. then much relevant scientific information 

would become unavailable tor use in setting standards to protect public health and the environment."). 

86 
166 


33371.148

EPA claims: "The proposed rule takes into consideration the policies or 

recommendations of third party organizations who advocated for open science."381 The sentence 

is accompanied by a footnote listing a number of organizations, for most of them not providing 

reference to any specific policies, recommendations, or statements. 382 

One of these vague references points to the Administrative Conference of the United 

States' Science in the Administrative Process Project, without providing further detail. 

Assuming that EPA is referring to the Administrative Conference of the United States' 

Recommendation 2013-3: Science in the Administrative Process, Wendy Wagner, sole author of 

ACUS 's final report Science in Regulation: A Study of Agency Decisionmaking Approaches and 

who served on the panel that produced the Bipartisan Policy Center's recommendations also 

cited by the Proposal has stated: 'They don't adopt any of our recommendations, and they go in 

a direction that's completely opposite, completely different. ... They don't adopt any of the 

recommendations of any of the sources they cite. I'm not sure why they cited them''383 While 

ACUS recommends agencies increase transparency of how they rely on scientific information 

and strive to make data underlying scientific information publicly available, nowhere does it 

suggest that agencies should not consider or rely on studies where underlying data and models 

cannot be made publicly available, or that these circumstances make scientific information less 

valid. ACUS instead suggests that information be made publicly available "to reproduce or 

assess the agency's technical or scientific conclusions" "[c]onsistent with the limitations in the 

lntormation Quality Act (IQA) guidelines issued by the Office of Management and Budget and 

its own IQA guidelines"384 Moreover, ACUS acknowledges valid limitations on public 

disclosure of data such as legal protections for privacy, trade secrets, and confidential business 

information. 385 Thus, ACUS recommends data be made public only "[t]o the extent practicable 

and permitted by law and applicable policies."386 Unlike the Proposal, the recommendation 

acknowledges that agencies may still use information where underlying data cannot be publicly 

disclosed, and suggest agencies "note that fact and explain why they used the results if they 

chose to do so."387 It thus provides a much more nuanced policy recommendation than that 

outlined in the Proposal-which suggests EPA either find a way to make underlying data and 

models public, despite the numerous potential obstacles and concerns in doing so, or completely 

disregard the research study. 

3

" 83 Fed. Reg. at 18.770. 

lSO 83 Fed. Reg. at 18.770. n. I 0 ("These include policies and recommendations fi·om: The Administrative 

Conference of the United States' Science in the Administrative Process Project; National Academics· reports on 

Improving Access to and CoJ?fidentia/ity c~f Research Data, £rpanding Access to Research Data, and Access to 

Research Data in the 2 /5'1 Centwy; the Health Effects Institute: Center for Open Science; members of the Risk 

Assessment Specialty Section of the Society ofToxicology, the Dose Response Section of the Society lor Risk 

/\nalysis. and the International Society for Regulatory Toxicology and Pharmacology~ and the Bipartisan Policy 

Center·s Science fOr Policy Project"'), 383 Robinson Meyer, Scott Pruill 's New Rule Could Completely Tran.~(orm the EPA, The Atlantic (Apr. 25, 2018), 

https :/ /www. theatlantic. com/sci cnce/arch i vc/20 I 8/04/how-thc~epas-nev,r-secrct -science·ru I c/5 58 8 78/. 

Js.~ ifdmini.slratil•e Conference Recommendation 2013-3: Science in the Administratire Process, 78 Fed. Reg. 4J,Jj2. 

41.358 (July 10, 2013). 385 78 Fed. Reg. 41.352, 4U58 n.l2 (July 10. 2013). 386 78 Fed. Reg. 41.352.41.358 (July 10. 2013). 

m 78 Fed. Reg. 41,352.41,358 (July 10, 2013). 

87 
167 


33371.149

EPA's claims that its Proposal is consistent with the policies of major science journals is 

similarly misleading. 388 EPA does not explain why the policies of scientific journals regarding 

the disclosure of data underlying their published studies should inform how an agency with a 

mission to protect human health and the environment uses research for regulatory actions. 

Additionally, these journals' policies provide exceptions for when privacy or other concerns do 

not allow for public sharing of data, and they never represent that this on its own weakens the 

validity of the research. 389 And, as discussed supra in Section l.B.2.a), the editors of these 

journals have specifically dismissed the Proposal.390 

EPA wrongfully claims its policy is consistent with existing OMB and EPA policies, 

while failing to recognize that these polices-while advocating for more transparency-take a 

measured, nuanced approach to data disclosure.391 EPA cannot finalize this policy without 

acknowledging and providing a reasoned explanation for its divergence from long-standing 

policy and without providing actual evidence that supports the Proposal, which it has not done. 

Prior policies recognize that government decision-making requires considering all scientific 

information, and legitimate limitations to data disclosure should not obstruct sound policymaking. EPA cannot rely on these documents to support the rule, leaving an inadequately thin 

record of evidence to support the Proposal, and must respond to policy rationales articulated in 

these documents as it now changes course. 

'

88 83 Fed. Reg. at 18.770 (EPA states that the policies and recommendations it considered were "informed by the 

policies recently adopted by some major scientific journals and cites to ''related policies from the Proceedings of the 

National Academy of Sciences. PLOS ONE, Science. and Nature.''): 83 Fed. Reg. at 18.771 n. 20 (citing "policies or 

recommendations of publishers Taylor & Francis~ Elsevier, PLOS. and Springer Nature" as potential mechanisms 

for compliance with Proposal). 

w> Taylor & Francis, Data Sharing /-<AQs, https://authorservices.taylorandtl·ancis.com/data-sharing-faqs/ (All our 

policies allow exceptions where data sharing violates protection of human subjects or other valid subject privacy 

concerns.) (last accessed Aug. 15. 2018): Else! vier, Research Data Policy. https://\vww.elsevier.com/about/our~ 

busincss/policies/rescarch~data (policy merely encourages when possible. rather than requires, data sharing: 

"Research data should be made available fi·ee of charge to all researchers wherever possible and with minimal reuse 

restrictions.") (last accessed Aug. 15. 2018): PLOS One, Data Availability. http://journals.plos.org/plosonc/s/dataavailabilitv (allows exceptions to making data public "for ethical or legal reasons. e.g., public availability would 

compromise patient confidentiality or participant pri\'acy·· or present other threats) (last accessed Aug. 15. 20 18); 

Springer Nature. Research data policies F4Qs, https://group.springernature.com/gp/authors/researchwdatapolicv/fags/12327154 ("'reasonable restrictions on data availahility arc permitted to protect human privacy. biosafety 

or respect rc<lsonable terms of use for data obtained under license tl·om third partie$.'') (last accessed Aug. 15, 2018). 

See, also. discussion in Appendix A. 

y:oo Jeremy Berg eL al.. Joint statement on EPA proposed rule and public rn·ai/ability of data, Science (Apr. 30. 

20 18). http://science.scicnccmag.org/content/early/20 18/04/30/science.aauO 116. 

'

91 EPA states: "This proposed rule is also consistent with ... the focus on transparency in OMI3's Guidelines for 

Ensuring and :Ha:r:imi:ing the Qua/it_v. Objectiri/y. UtWty and Integrity qf lr?formation Disseminated by Federal 

Agencies (the Guidelines) and OMB Memorandum 13-13: Open Data Policy-Managing Information as an Asset." 

83 Fed. Reg. at 18.769-70. EPA says the Proposal '·builds upon prior EPA actions in response to government wide 

data access and sharing policies." that it applies ''concepts and lessons learned" tl·om implementation of to the 2016 

Plan to Increase Access to Results of EPA-Funded Scientific Research. 83 Fed. Reg. at 18.770. also citing to EPA 

Open Government Plan -1. 0. Open Data lmplementalion Plan. EPA ·s Scient{fic lntegri(v Pol/c)!, and Guidelinesfor 

Ensuring and ;Haximi:ing the Quality, Objectivity, Utility, and lntegr;ty of il?formation Disseminated by the 

r-"tn·ironmental Protection Agency. 83 Fed. Reg. at 18.770 n. 8. 

88 
168 


33371.150

The Plan to Increase Access to Results of EPA-Funded Scientific Research, discussed 

supra at I.B.2.b), represents the view EPA has consistently espoused in the past, that when it can 

make data available without compromising other critical values, it does, but will not exclude 

information from its consideration when it cannot. 392 

EPA cites to its implementation ofOMB's guidelines, Guidelines/or Ensuring and 

Maximizing the Quality, Objectivity, Utility, and Integriry of Information Disseminated by the 

Environmental Protection Agency. These Guidelines note "[t]he mission of the EPA is to protect 

human health and safeguard the natural environment upon which life depends'' and "[t]he 

collection, use, and dissemination of information of known and appropriate quality are integral to 

ensuring that EPA achieves its mission."393 They thus highlight that the controls on data quality 

exist to allow EPA to meet its mission-unlike the Proposal. which changes EPA's existing view 

by placing transparency of data, apparently for its own sake even when unrelated to data quality, 

ahead of EPA's ability to achieve its mission. As explained above in Sectioni.C, the Proposal 

violates the Information Quality Act and these Guidclines 394 

EPA disregards the careful approach to data disclosure outlined in OMB Memorandum 

M-13-13, Open Data Policy-Managing Information as an Asset, which requires agencies to 

collect or create information in a way that supports downstream information processing and 

dissemination activities, and does not establish a policy of requiring agency data to be made 

public in order for the agency to be able to rely on it."' It recognizes that sharing agency data 

with the public can result in numerous benefits, but requires careful thought about privacy and 

confidentiality concerns. The memorandum establishes "a framework to help institutionalize the 

principles of effective information management at each stage of the information's life cycle to 

promote interoperability and openness," noting "[w]hether or not particular information can be 

made public, agencies can apply this framework to all information resources to promote 

efficiency and produce value."396 It places consideration of privacy concerns at the forefront, 

saying "[a]gcncies should exercise judgment before publicly distributing data residing in an 

existing system by weighing the value of openness against the cost of making those data 

public."397 EPA has provided no indication that it has carefully weighed these costs and benefits. 

Before agencies make data publicly available, OMB Memorandum M-13-13 requires that 

agencies "review the information collected or created for valid restrictions" such as legal, 

"privacy. confidentiality pledge, security, trade secret, contractual. or other valid restrictions to 

release.''"'' OMB recognizes these restrictions ''may affect the amount, type, form. and detail of 

391 See, also. discussion in Appendix A. 39 ~ EPA. Guidelines for Ensuring and Jvfaximi:ing the Quali(y, Objectivity, Utility, and Integrity (?f Information 

Disseminated by the Environmental Protection Agency (EPAi260R-02-008) 5 (Oct. 2002), 

https://www.epa.gov/quality/guidelines-ensuring-and-maximizing-qualitv-objcctivitv-utility-and-integrityinformation. 

394 See. also. discussion in Appendix A. 

"'5 OMB Memorandum M-13-13. Open Data Policy-Managing Information as an Asset 1 (May. 9. 2013). 

3% !d. 

m !d. at 6. 

NR /d. at 9. 

89 
169 


33371.151

data released by agencies."399 It also requires agencies to consider the "'mosaic effect' of data 

aggregation," discussed at Section II.A.2.b)ii, which EPA does not acknowledge at all in the 

Proposal:oo 

EPA's Open Government Plan 4.0 acknowledges that not all data is releasable to the 

public, even as it aims to "increase publicly accessible EPA data to support citizens' 

participation in government and promote transparency and accountability of Agency 

operations.""'' EPA states: "By providing releasable information in open and machine-readable 

formats, EPA enables the public and other organizations to better leverage the rich wealth of 

information available.''·"" EPA's own Open Data Policy notes that it is important to develop 

·'policies and processes to ensure that only appropriate data are released to the public and made 

available online."'03 To do so, EPA uses different "access levels" for different data sets, {public, 

restricted public and non-public) and notes that it may not be able to publicize data due to "law, 

regulation or policy, which address privacy, confidentiality, security or other valid 

restrictions."''" EPA has not made clear that restricted access would satisfy the requirement of 

making information ''publicly available." The Proposal seems to completely do-away with this 

multi-level, nuanced approach, imposing a blanket ''publicly available'' requirement for all 

studies EPA intends to rely on, despite obstacles to their release. 

The Proposal turns away from EPA's Scientific Jntegri(v Policy. which stresses "a firm 

commitment to evidence,"405 endorses use of"the best available science"406 and "[r]equire[s] 

reviews ... regarding the content of a scientific product to be based only on scientific quality 

considerations.'''"' The Proposal, on the other hand, inhibits use of sound scientific information 

and evidence by arbitrarily excluding science for reasons unrelated to its quality. While the 

policy ·'lr]ecognizes the value of independent validation of scientific methods""08 and facilitating 

''the free flow of scientific information" by making information available "including access to 

data and non-proprietary models underlying Agency policy decisions,"409 this is proposed as a 

flexible standard and an ideal to aspire to, not an absolute rule that takes priority over other 

competing interests-such as use of the best scientific information. As discussed more in Section 

VII.C this Administration has blatantly violated key aspects of the policy by silencing scientists 

and the dissemination of scientific information, which this Proposal seems aimed at continuing. 

directly undoing "EPA's longstanding commitment to the timely and unfiltered dissemination of 

its scientific information -uncompromised by political or other interference" and goal to 

communicate scientific findings openly and actively to the public."" By now placing 

'" Jd at 10 . 

..;oo !d at 9-10. 

lOI EPA. Open Go1'ernment Plan -10 4 (Sept. 2016)" 402 /d. (emphasis added). 40·

1 EPA. Open Data Policy Implementation Plan 4. httrs://\vww.epa.gov/sites/production/lilcs/2015· 

05/documents/opendatapolicvimplementalionplan 030415 linalb.pdf. 

''" Jd "'05 EPA. Scientific Integrity Polic.v 3. 

·

10'' Jd at 3-4. 

""!d. at 4. 

"' ld -iO') fd 

"

110 ld at 5. 

90 
170 


33371.152

"transparency" ahead of use of the best available science, aside from violating statutory 

requirements, EPA is changing its own policies and priorities and must justify this new position. 

In footnote 2, EPA dubiously claims the Proposal is consistent with the Memorandum for 

the Heads of Executive Department and Agencies on Scientific Integrity (Mar. 9, 2009).''' 

Notably, the Memorandum specifies, "Except for information that is properly restricted/rom 

disclosure under procedures established in accordance with statute, regulation, Executive Order, 

or Presidential Memorandum, each agency should make available to the public the scientific or 

technological findings or conclusions considered or relied on in policy decisions.""" Not only 

does the Memorandum provide no support for the notion that agencies should be barred from 

relying on studies where the underlying data is properly restricted from disclosure it additionally 

discusses disclosure only of findings and conclusions, not underlying data. 

Thus, despite EPA's claims to the contrary, the Proposal marks a shift in policy that EPA has 

up to this point followed EPA arbitrarily fails to acknowledge this shift, to identify good reasons 

for the change, or to explain why EPA believes the proposed rule would be an improvement over 

current mechanisms utilized by EPA to ensure the integrity of EPA's actions. 

2. EPA's Proposal fails to consider important implementation problems that 

existing EPA and federal government policies place at the forefront. 

An agency rule is arbitrary and capricious if it "entirely failed to consider an important 

aspect of the problem."413 EPA's Proposal completely fails to consider the numerous barriers that 

currently exist to making underlying data public. As highlighted in OMB and EPA policies, there 

is an understanding that the worthy goal of ensuring greater transparency of scientific 

information is in tension with other compelling, competing interests such as privacy and 

confidentiality. When these two are in tension, existing policies have recognized that this will 

prevent certain data from being publicly released-and that agencies still need to be able to use 

scientitlc information in these circumstances. Transparency goals should not override the ability 

of the agency to rely on otherwise valid scientific information as it goes about achieving its core 

mission. While the Proposal purports to take into account privacy and confidentiality concerns, it 

appears to do so by either grossly oversimplifying EPA's ability to address these concerns or by 

deeming all such information unusable--essentially completely failing to consider the problems 

of this approach. 

OMB Circular A-130 recognizes that the values of openness. transparency, and allowing 

the free flow of information between the federal government and the public are important values, 

they must be contextualized. Thus, it cautions: "Promoting openness and interopcrability, subject 

" 1 83 Fed. Reg. at I S.769 n. 2 {"lfscientitic and technological intormation is developed and used by the Fcdernl 

Oovernment. it should ordinarily be made available to the public. To the extent permitted by law. there should be 

transparency in the preparation. identification. and use of scientific and technological information in 

policymaking.") 

"' Memorandum for the Heads of Executire Department and Axencies on Scientific Integrity (:V!ar. 9, 2009). 74 

Fed. Reg. I 0671 (Mar. II, 2009). https://obamawhitehouse.mchives.gov/the-press-otTicc/memorandum-headscxecutive-departments-and-agencies-3-9-09 (emphasis added). 413 A-lotor Vehicle A(frs. Ass 1

n r. Stale Farrn lvfut. Auto. Ins. Co., 463 U.S. 29,43 (1983). 

91 
171 


33371.153

to applicable legal and policy requirements, increases operational efficiencies, reduces costs, 

improves services, supports mission needs, and increases public access to valuable Federal 

information.''414 Similarly it states: "The open and efficient exchange of scientific and technical 

Federal information, subject to applicable security and privacy controls and the proprietary 

rights of others, fosters excellence in scientific research and effective use of Federal research and 

development resources."415 Circular A-130 makes clear that "[p]rotecting an individual's privacy 

is of utmost importance. The Federal Government shall consider and protect an individual's 

privacy throughout the information life cycle."416 It requires that agencies recognize that 

"Federal information is managed by making information accessible, discoverable, and usable by 

the public to the extent permitted by law and subject to privacy, security (\vhich includes 

confidentiality), or other valid restrictions pertaining to access, use, dissemination, and 

disclosure ... . "417 

Further, Circular A-130 requires agencies to "[l]imit the creation. collection, use, 

processing, storage, maintenance, dissemination, and disclosure of [personally identifiable 

information] to that which is legally authorized, relevant, and reasonably deemed necessary for 

the proper performance of agency functions" and "[t]o the extent reasonably practicable .. 

. reduce all [personally identifiable information] to the minimum necessary for the proper 

perlormance of authorized agency functions."' 18 

and: 

The appendix to the Circular realizes that privacy protections require ongoing progress 

Emerging technologies and services may continue to shift the ways in which agencies 

acquire, develop, manage, and use information and technology. As technologies and 

services continue to change, so will the threat environment. Agency programs must have 

the capability to identify, respond to, and recover from current threats while protecting 

their information resources and the privacy of the individuals whose information they 

maintain.419 

OMS Memorandum M-14-06 specifically lays out policies intended to help agencies 

make the most of"administrative data that cannot be made publicly available due to statutory, 

regulatory, or policy protections," for statistical purposes, including ''activities typically 

characterized as research, evaluation, and analysis. as long as the focus of those activities is on 

reporting aggregate findings about a group."420 It notes "[s]ome administrative data can be 

publicly released, whereas other administrative data cannot be released ... [and] it is the case that 

both types of administrative data (public and nonpublic) can be useful for Federal statistical 

' 14 OMB Circular A-130 at 3 (emphasis added). 

"'/d. at 4 (emphasis added). 

-W'fd 

m ld at 14 (emphasis added). 018 !d. at 17. 

"'Jd at Appendix 1-1. 420 OMB Memorandum M-14-06 at 6. 

92 
172 


33371.154

purposes," suggesting agencies should not abandon reliance on data not able to be publicly 

released.'2 1 

OMB Memorandum M-11-02 "strongly encourages Federal agencies to engage in 

coordinated efforts to share high-value data" but notes that in certain cases sharing data will 

contravene other compelling concerns and that federal agencies need to think about applicable 

privacy laws, regulations, and policies to "fully protect[] individual privacy" and preserve public 

trust.422 Unlike the Proposal, it takes a more nuanced approach recognizing that sharing data is 

not always appropriate and should only be done "responsibly and appropriately."423 

OMB recognizes that even when just sharing information among agencies, privacy 

concerns must be weighed against those benefits that agencies can achieve with sharing data: 

''Agencies should work together to determine what data sharing opportunities are desirable, 

feasible, and appropriate. In general, data sharing should only be pursued if the benefits 

outweigh the costs."424 

OMB Memorandum M-1 0-06 also encourages ''a plan for timely publication of the 

underlying data ... in an open format and as granular as possible, consistent with statutory 

responsibilities and subject to valid privacy, confidentiality, security, or other restrictions."-115 

The memorandum aims to achieve "transparency, participation, and collaboration,"426 

recognizing that not making data available does not deter those goals when there are valid 

concerns and the legitimacy of the data is not otherwise questioned. 

EPA's Dra.fi Strategic Data Action Plan Version 1.0 similarly aims to work towards a 

more open government, and to increase the public's access to high quality data. However, the 

agency recognizes barriers to this goal, not applying the plan to "data resources containing 

Confidential Business Information (CBI) or sensitive data that arc not available for public 

access."427 In similarly recognizes that "[i]n order to protect the privacy and security of the 

public, businesses, and US Government staff and operations, some types of data may be deemed 

sensitive and will not be made public or published on Data.gov."428 

These all highlight instances where EPA and OMB have recognized that privacy and 

confidentiality present ongoing concerns that are not easily addressed and that conflict with other 

aims of federal government. Yet, they recognize that protecting information in these cases is a 

valid path, and not making data public does not compromise the validity of the findings or 

-+:!t ld at 2. 

122 OMB Memorandum M-ll-02. 

'" !d .Q4 Memoranda OI~05 --Guidance on InterAgency Sharing of Personal Data- Protecting Personal Privacy (Dec. 20, 

2000). https://www. whitchouse.gov/wp-contentluploads/20 17/ll/200 l-M-0 l-05-Guidance-on-lnter-i\gencyS hari ng-o t~Personai-Data- Protecting -Person a !-Privacy .pdf. 

·!25OMB Memorandum M-1 0-06 on Open Government Directive at 8. 

426 /d. at l. 

427 EPA. Draft Strategic Data Action Plan Version J. n 3 (Mar. 20 II) 

https://\V\V\v.epa.gov/sites/production/ti les/documents/epa sdap v I.O.pdf. 

428 /d. at 14. 

93 
173 


33371.155

conclusions upon which the data is based and should prevent agencies from using those findings, 

conclusions, and data to inform their work. The Proposal provides no explanation for why EPA 

is now changing its view to a conflicting one, making the Proposal arbitrary. 

liL The Proposed Rule's Peer Review Provisions Raise Numerous Concerns. 

Proposed section 30.7 provides that "EPA shall conduct independent peer review on all 

pivotal regulatory science used to justify regulatory decisions consistent with the requirements 

of the OMI3 Final Information Quality Bulletin for Peer Review (70 Fed. Reg. 2664) and the 

exemptions described therein." This proposed provision generally appears to be designed to 

enshrine OMB's existing peer review requirements for "influential scientific information."429 

Remarkably, the preamble to the proposed rulemaking lacks any explanation whatsoever 

for why EPA is proposing this new peer review requirement or what its impact might be. EPA 

has additionally not provided any information to suggest that EPA is not already following 

OMB's Peer Review Bulletin. EPA's lack of any supporting rationale or analysis frustrates the 

public's ability to provide meaningful comment on this provision,430 and is itself a sign that this 

requirement is fundamentally arbitrary. In addition, the discussion below outlines several 

specific concerns with this proposed regulatory requirement. 

A. EPA Has Failed to Consider the Costs of Making OMB Peer Review 

Requirements Judicially Enforceable. 

The most obvious change wrought by EPA's incorporation ofOMI3's Peer Review 

Bulletin into EPA's regulations is that it apparently would make the OMB Peer Review 

requirements judicially enforceable. At present, OMB Peer Review Bulletin requirements are not 

judicially enforceable."31 Rather, the Bulletin ·'specifically disclaims that its contents create any 

enforceable rights, thereby preserving the agency's discretion to interpret and apply" the 

Bulletin.432 If EPA finalizes its proposed peer review rules, EPA may find itself subject to 

countless legal challenges to its regulations based on compliance with OMB Peer Review 

requirements. These additional legal challenges would come at a cost, including the financial 

cost of increased litigation as well as the cost to public health and the environment when 

unwarranted legal challenges lead to lengthy delays in implementation of needed regulatory 

protections. Given that EPA is already subject to OMI3 Peer Review requirements. it is unclear 

OMB. Final h?formation Quality Bulletinfor Peer Re1·iew, 70 Fed. Reg. 2664. 2677 (Jan. 14. 2005) fllcreinaftcr: 

OMB Peer Review Bulletin}. 

' 30 See Connecticut Light & Pmrer Co. r. Nuclear !legulaiOIY Com .. 673 F.2d 525.530 ([).C. Cir. 1982) ('The 

purpose of the comment period is to allow interested members ofthc public to communicate information. concerns. 

and criticisms to the agency during the rule-making process. If the notice of proposed rulemaking tails to provide an accurate picture of the reasoning that has led the agency to the proposed rule, interested 

parties \viii not be able to comment meaningfully upon the agency's proposals."); Honeywell fnt'/, inc. l'. EPA. 372 

F.3d 441.445. (D.C. Cir. 2004) ("Under the Administrative Procedure Act, a notice of proposed rulemaking must 

.. provide sufficient t~Ktual detail and rationale for the rule to permit interested pm1ies to comment meaningfully."). 

·'" OMB Peer Review Bulletin~ XII. 70 Fed. Reg. a12674 ("This I3ullclin is intended to improve the internal 

management ofthc executive branch. and is not int~nded to, and does not create any right or benefit. substantive or 

proceduraL enforceable at law or in equity, again~t the United States, its agencies or other entities, its oHicers or 

employees. or any other person.""). 

!"amity Farm Alliance v Sala=ar, 749 F.Supp. 2d 1083, 1095 IE.D. Ca. 20111). 

94 
174 


33371.156

whether the proposed regulation would provide any new benefits in terms of ensuring that EPA's 

regulations are based on valid and unbiased science. Yet the administrative record for this 

proposed rulemaking is devoid of any EPA analysis of the costs and benefits of making the 

existing peer review requirements judicially enforceable. EPA must carefully evaluate the 

anticipated costs and benefits from these proposed regulatory requirements and provide a 

reasoned explanation for why they are needed. 

B. EPA Must Clarify that Studies that Have Already Been Adequately PeerReviewed by Third Parties Need Not be Re-Reviewed by EPA. 

Because proposed section 30.7 expressly incorporates the OMB Peer Review Bulletin 

''and the exemptions described therein," it appears that EPA intends to incorporate the OMB 

Peer Review Bulletin provision providing that "'agencies need not have further peer review 

conducted on information that has already been subjected to adequate peer rcview."433 However, 

there is some ambiguity due to language in proposed section 30.7 instructing that EPA must "ask 

peer reviewers to articulate the strengths and weaknesses of EPA's justifications for the 

assumptions applied and the implications of those assumption for the results." Obviously, peer 

review conducted prior to EPA's reliance on a study would not have involved review of the 

strengths and weaknesses of EPA's justifications. If EPA were required to re-peer review all 

influential scientific information, this rulemaking would burden EPA with needless and 

significant costs that likely would bring many EPA rulemakings to a standstill, preventing EPA 

from fulfilling its statutory mission of protecting public health and the environment. To prevent 

this from happening. EPA must clarify that the proposed rule will not supplant EPA's existing 

authority under the OMB Peer Review Bulletin not to conduct further peer review where 

information has already been subject to adequate peer review-and that such prior peer review is 

not subject to the requirement in proposed section 30.7 that reviewers consider the strengths and 

weaknesses of EPA's justifications. 

C. EPA Must Clarify the Intent of the Exemption Provision with Respect to 

Peer Review Requirements and Confirm that the OMB Peer Review Bulletin's 

Waiver Provision Would Remain in Effect for EPA. 

EDF does not support the peer review provisions for the reasons detailed in this section. 

but if EPA moves ahead with these proposed provisions, EPA must revise the proposed 

regulatory language to clarify that the waiver authority provided by the OMB Peer Review 

Bulletin-which OMB itself has emphasized "ensure[s] needed tlexibility"-would remain in 

effect for EPA even if EPA finalizes the proposed peer review regulations.434 

Proposed section 30.9(b) provides that the Administrator may grant an exemption from 

the peer review requirements if he or she determines that "[it] is not feasible to conduct 

independent peer review on all pivotal regulatory science used to justify regulatory decisions for 

reasons outlined in OMB Final information Quality for Peer Review (70 FR 2664), Section IX." 

Oddly, however, only two of the seven enumerated exemptions in Section IX of the OMB Peer 

411 OMB Peer Review Bulletin. 70 Fed. Reg. at2675. 

m OMB Peer Review Bulletin. 70 red. Reg. at2673. 

95 
175 


33371.157

Review Bulletin pertain to feasibility-Exemption 1 governing "national security, foreign 

affairs, or negotiations involving international trade or treaties" and Exemption 3 governing 

time-sensitive health or safety disseminations. 435 If EPA decides to finalize peer review 

requirements, EPA must amend its proposed regulation to clarify that all of the exemptions set 

forth in section IX of the OMB Peer Review Bulletin remain in effect regardless of whether they 

pertain to feasibility. Furthermore, EPA must clarify what, if any, additional effect is intended by 

the exemption provision in proposed section 30.9. 

Additionally, EPA must amend the proposed rule to confirm that the "Deferral and 

Waiver" provision set forth in Section VIII of the OMB Peer Review Bulletin remains in effect 

for EPA. That provision provides: 'The agency head may waive or defer some or all of the peer 

review requirements of Sections II and Ill of this Bulletin where warranted by a compelling 

rationale. If the agency head defers the peer review requirements prior to dissemination, peer 

review shall be conducted as soon as practicable." 416 OMB explained that this provision 

"ensure[s] needed flexibility in unusual and compelling situations not otherwise covered by the 

exemptions in the Bulletin before information is disseminated.''437 If EPA were to finalize the 

"exemption" language in proposed section 30.9(b) without clarification, it is possible that it 

could be read to encompass the entirety of the Administrator's ability to grant exemptions, 

supplanting Section VIII of the OMB Peer Review Bulletin. 

D. EPA Must Clarify How the Proposed Rule Would Impact EPA's Existing 

Peer Review Handbook. 

EPA's Peer Review Handbook incorporates the provisions of OMS's Peer Review 

Bulletin.m In the I land book, EPA confirms that it "conducts peer review of its products in 

accordance with the guidance in the OMB Peer Review Bulletin."439 However, the EPA Peer 

Review Handbook adds details and specific procedures that are not present in the OMB Peer 

Review Bulletin. 

Surprisingly, EPA's proposed peer review regulations do not even mention EPA's Peer 

Review Handbook, let alone explain how the new proposed regulations would impact EPA's 

compliance with the Handbook. For example, EPA's Handbook specifies "exemption criteria" in 

Section 3.3.'40 EPA must clarify whether anything in the proposed peer review regulation would 

supplant instructions in the Peer Review Handbook, and if so, provide a reasoned explanation for 

the change. Likewise, EPA must explain the role of the Peer Review Handbook going forward in 

administering peer review requirements. 

435 OMB Peer Review Bulletin, 70 Fed. Reg. at 2674. 436 OMB Peer Review Bulletin, 70 Fed. Reg. at 2673. 

m OMB Peer Review Bulletin, 70 Fed. Reg. at 2673. 

mu.s. EPA. Science and Technology Policy Council Peer Review Handbook. 4th Ed. (2015), 

https://wvvw.epa.govisites/production/liles/20 !6-03/documents/epa peer review handbook 4th edition.pdf. 

[Hereinaller: EPA Peer Review Handbook]. 43" EPA Peer Review Handbook at 26. 

" 0 EPA Peer Review Handbook at 44-45. 

96 
176 


33371.158

IV. The Proposal Would Impose Arbitrary and Inappropriate Methods for Assessing Health 

Risks 

A. EPA's Proposal Seeks to Undermine Key Scientific and Public Health Tenets 

Relating to Dose-Response and the Use of Defaults. 

The proposed rule asserts that a broad interest of the current Administration is to "ensure 

that the data and models underlying scientific studies that are pivotal to ... regulatory action are 

available to the public" 441 and to "change agency culture and practices regarding data access so 

that the scientific justification for regulatory actions is truly available for validation and 

analysis."442 However, the Proposal specifies a particular interest and initial focus on "dose 

response data and models" as evident throughout the preamble and proposed regulatory 

provisions. 

Dose-response studies are a critical clement of risk assessments for toxicants including 

air pollutants. Assessment of a toxicants risks typically proceeds through a tour-step process: I) 

hazard identification, 2) dose-response assessment, 3) exposure assessment, and 4) risk 

characterization.H3 Dose-response assessment describes the relationship between exposure to a 

toxicant and observed e!Tect on human or ecological receptor. EPA provides the following 

description of dose-response on its website: "Dose-Response Assessment. .. characterizes the 

quantitative relationship between chemical exposure and each credible health hazard. These 

quantitative relationships are then used to derive toxicity values."4

" Dose-response plays a 

central role in the evaluation of chemical risks as it provides the characterization of the potency 

or effect size of the toxicant. In other words, dose-response assessment is used to determine the 

levels of exposure at which adverse effects will occur and thus informs what risk management 

actions should be taken to protect human and ecological health. Dose-response assessments are 

commonly used to derive chemial toxicity values. The lower a substance's toxicity value the 

greater its potency and the less exposure is necessary tor an effect to occur. 

EPA reveals the underlying motivation behind its interest in transparency of doseresponse data and models on page eight of the Proposal, where it states: 

In addition, this proposed regulation is designed to increase transparency of the 

assumptions underlying dose response models. As a case in point, there is growing 

empirical evidence of non-linearity in the concentration-response function for 

specific pollutants and health ctTects. The use of default models, without 

consideration of alternatives or model uncertainty, can obscure the scientific 

justification for EPA actions. To be even more transparent about these complex 

relationships, EPA should give appropriate consideration to high quality studies 

441 Proposed Rule, 83 Fed. Reg. at 18769-70. 442 Proposed Rule. 83 Fed. Reg. at 18770. 

HJ EPA. Conducting a Human Health Risk Assessment, https;//\\'WW.epa.gov/risk!conducting-human-hcalth-riskassessmcnt (last accessed Aug. 16. 2018). 444 EPA, Basic b?formalion about the Integrated Risk il!formation S)>stem, https://www.epa.gov/iris/basicin1<.xmation-about-integratcd-risk-information-svstem (last accessed Aug. 16. 2018). 

97 
177 


33371.159

that explore: A broad class of parametric concentration-response models with a 

robust set of potential confounding variables; non parametric models that 

incorporate fewer assumptions; various threshold models across the exposure 

range; and spatial heterogeneity. EPA should also incorporate the concept of 

model uncertainty when needed as a default to optimize low dose risk estimation 

based on major competing models, including linear, threshold, and U-shaped, Jshaped, and bell-shaped modcls. 44' 

This excerpt raises several troubling and erroneous concepts that are contrary to core scientific 

tenets and best practices in chemical hazard and risk assessment as discussed extensively in a 

seminal 2009 report by the National Academies (Academies): Science and Decisions: Advancing 

Risk Assessment (Science and DecisiomJ"46 The report was requested and sponsored by EPA's 

National Center for Environmental Assessment and was developed over a three-year period by a 

15-member committee that included state environmental agencies, non-governmental 

organizations, industry, and academic institutions. The committee was specifically tasked with 

"developing scientific and technical recommendations for improving risk analysis approaches 

used by EPA, including providing practical improvements that EPA could make in the near term 

(2-5 years) and in the longer term (1 0-20 years)."447 The report has been cited over 400 times in 

the scientific literature. 

The Proposal fails to discuss these best practices for risk assessment, much less provide 

any persuasive reason for departing from them. The Proposal provides no support for its 

assertion that there is "growing empirical evidence" of nonlinearity in dose-response 

relationships; fails to acknowledge or contend with the National Academies' finding that nonthreshold dose-response relationships are common for toxicants, and should be assumed as a 

default; fails to discuss the well-known rationales put forward by the National Academies for 

using default models; and irrationally prioritizes consideration of studies that employ a wide 

range of dose-response models, without any consideration for whether those alternative doseresponse models are appropriate for risk assessment. Alarmingly, the Proposal offers no analysis 

of how the proposed requirements to consider threshold-response relationships and avoid default 

models would tltrther the protection of human health and the environment-and gives no 

indication that the Agency has considered whether its proposed approach affords appropriate 

protection for the public in evaluating the risks of dangerous pollutants and toxicants. The 

proposed requirement is irretrievably arbitrary and unjustified, and must be withdrawn. 

I. The proposal arbitrarily dismisses linear (i.e .. non-threshold) doseresponse relationships. 

EPA makes a blanket assertion that "there is growing empirical evidence of non-linearity 

in the concentration-response function for specific pollutants and health efTects" without any 

evidentiary basis.448 In contrast. in Science and Decisions, the Academics discussed at length the 

·' 15 Proposed Rule, 83 Fed. Reg. at 18770. 

·H6 National Academies. Science and Decisions: Advancing Risk Assessment (2009}, 

h ttps:/ I W\V\V. nap. edu/ cat a! og/ J 2209/sci ence-and ~decisi ons-advanci n!! -risk -assessment. --147Jd. 

" 8 Proposed Rule. 83 Fed. Reg. at 18770. 

98 
178 


33371.160

evidence for the opposite. Namely, non-linear dose-response relationships-that is the existence 

of thresholds of chemical exposure below which effects are not expected to be observed-is the 

exception rather than the rule when considering background exposures, co-exposures, variability 

across the diverse population and other considerations. The Science and Decisions report notes: 

... [A]n individual's risk from exposure to an environmental chemical is 

determined by the chemical itself. by concurrent background exposures to other 

environmental and endogenous chemicals that affect toxicity pathways and 

disease processes. and by the individual's biologic susceptibility due to genetic, 

lifestyle, health, and other factors. How the population responds to chemical 

insults depends on individual responses, which vary among individuals. 149 

In this regard. it is important to note that risk assessments are typically designed to 

estimate incremental risk in the population due to exposure to a single hazard. As discussed by 

the Academies, individual risk is determined by both the chemical exposure and an individual's 

unique circumstance of factors (e.g., co-exposures and susceptibilities). Cancer incidence in the 

population illustrates the significance of these additional factors in considering actual individual 

risk to a particular chemical exposure. Individual lifetime risk of developing cancer is 1 in 3, and 

I in 5 for dying from cancer,450 indicating a substantial population baseline risk resulting from a 

large number of exposures and other risk factors. Assuming that there is somehow a threshold for 

everyone cannot be supported by the evidence. Therefore, given that the mission of EPA is to 

protect public health, the linear approach is most appropriate unless there is strong evidence in 

favor of an alternative as recommended in Science and Decisions. 

EPA currently approaches risk assessment of I) carcinogens and 2) noncarcinogens and 

carcinogens "acting through an MOA [mode of action] considered nonlinear at low doses"451 

separately-applying a linear dose-response framework for the former and a non-linear doseresponse framework for the latter. The Academics strongly argued against this arbitrary 

distinction and recommended a uniform linear approach to the assessment of all chemicals. 

Indeed. for carcinogens purported to have a non-linear MOA, the Academies indicated: 

... omissions in this overall approach for low-dose nonlinear carcinogens could 

yield inaccurate and misleading assessments .... [T)he current EPA practice of 

determining "'nonlinear" MOAs does not account for mechanistic factors that 

create linearity at low dose. The dose-response relationship can be linear at a low 

dose when an exposure contributes to an existing disease process. Effects of 

exposures that add to background processes and background endogenous and 

exogenous exposures can lack a threshold if a baseline level of dysfunction occurs 

without the toxicant and the toxicant adds to or augments the background process. 

Thus, even small doses may have a relevant biologic effect. That may be difticult 

.qq National Academies. Science and Decisions: Advancing Risk Assessment 135 (2009). 450 American Cancer Society. Lifetime Risk of Developing or Dying From Cancer. 

https:/ /u.rww .c:ancer.org/canccr/ cancer~has ics/1 i feti n1e-probahi I itv-o f .. developi n g ·or-dying· fi·om -cancer .htm I (I ast 

revised Jan. 4, 2018). 1 National Academies. Science and Decisions. ~d,·ancing Risk Assessmentl29 (2009). 

99 
179 


33371.161

to measure because of background noise in the system but may be addressed 

through dose-response modeling procedures. Human variability with respect to 

individual thresholds for a nongenotoxic cancer mechanism can result in linear 

dose-response in the population.452 

Similarly, for noncarcinogens, the Academies indicated that "noncarcinogens can 

exhibit low-dose linearity, for example, when there is considerable interindividual 

variability in susceptibility and each individual has his or her own threshold, especially 

when an underlying disease (such as cardiopulmonary disease) can interact with the 

toxicant (such as pmiiculatc matter [PM] or ozone)."453 

The Academies ultimately and definitively recommended that "cancer and 

noncancer responses be assumed to be linear as a default. .. [and that] [a]n alternative 

analytic option ... is available for cases in which it can be shown that background is 

unlikely to be an important contributor to risk, according to the recommended evaluation 

ofMOAs and background."454 

2. The proposal improperly dismisses defaults. 

EPA's Proposal also indicates an interest and intent to move away from "default models, 

without consideration of alternatives or model uncertainty'' which purportedly "can obscure the 

scientific justification for EPA actions.''455 Here, EPA demotes and ignores the purpose of 

science-based defaults, in suggesting that lhey '"obscure the scientific justification for EPA 

actions" while simultaneously encouraging routine application of model alternatives without 

meaningful justification or substantiation. 

Again, EPA's Proposal deviates significantly from the recommendations in Science and 

Decisions where the Academies wrote, 

[D]efaults need to be maintained for the steps in risk assessment that require 

inferences or to till common data gaps. Criteria arc needed for judging whether, in 

specific cases, data arc adequate to support a different inference from the default 

(or whether data are sufficient to justify departure from a default). 456 

The Academies further recommended that l) ·'EPA should continue and expand use of 

the best, most current science to support or revise its default assumptions," 2) "work toward the 

development of explicitly stated defaults to take place of implicit or missing defaults," and 3) 

that "departure [from defaults] should occur only when the evidence of the plausibility of 

alternatives is clearly superior to the evidence of the value of the default."457 These 

recommendations underscore and reaffirm the role of defaults, and make clear that deviations 

452 National Academies, ~)'cience and Decisions: Advancing Risk Assessment 129-30 (2009). 

-1 5:< National Academies. Science and Oi?cisions: Adrcmcing Risk Assessment 131 (2009). 

-IS-I National Academies. Science and Decisions: :tdvancing Risk Assessment 180 (2009). 

Proposed Rule. 83 Fed. Reg. at I 8770. 45 (, National Academics. Science and Decisions: Advancing Risk Assessment207 (2009) . 

.157 !d 

100 
180 


33371.162

from defaults are to be considered carefully, on a case-by-case basis, and only when adequately 

justified. 

3. The Proposal arbitrarilv promotes studies that include a variety of doseresponse models. 

EPA's Proposal promotes the use of studies that explore a variety of dose-response 

models. Use of dose-response models to estimate pollutant or chemical risk should generally 

address issues such as goodness-of-tit, confidence bounds around predicted risks, biological 

plausibility, and sensitivity of the prediction to untested assumptions. 458 

However, giving higher weight to studies that use a wide range of models just because 

they use a wide range models is wholly inappropriate, arbitrary, and without scientific or public 

health justification. In fact, it creates a perverse incentive to apply multiple models to data 

without regard to appropriateness of fit and underlying assumptions (among other key 

considerations), and importantly, without regard to public health and ecological protection. It is 

worth noting that nowhere in the Proposal has the agency articulated how this requirement would 

further its primary mission and purpose of protecting human health and the environment. 

There are numerous dose-response analyses that could be applied to any data set. Any 

analysis of the data assumes an underlying statistical distribution of the data, models for mean 

response, variance structures, shapes, and other data fit considerations that are subject to choice 

in the formal analysis. Scientists have historically used a reduced set of science-based, 

empirically supported models for specilic types of data that have obtained widespread 

acceptance. EPA's specification of various types of modeling approaches the agency should 

consider ignores this reality. 

4. The proposed rule provides no justification for codifying scientific 

approaches into regulation. 

The proposed rule's provisions addressing dose-response models are inappropriate for the 

numerous reasons discussed in this section. They also unnecessarily and inappropriately 

memorialize highly complex and technical scientific issues into regulation-a generally frowned 

approach given the inherently evolving nature of science. These issues arc more appropriately 

dealt with in guidance, a more flexible vehicle better equipped for adapting to new scientific 

understanding and in this way supporting use of best available science. 

V, EPA Fails to Adequately Consider Costs and Benefits of the Proposal. 

It is arbitrary and capricious to "'entirely tai[l] to consider an important aspect of the 

problem' when deciding whether regulation is appropriate." l'vfichigan v. EPA, 135 S. Ct. 2699, 

2707 (2015) (quoting State Farm, 463 U.S. at 43). As in Michigan, failure to consider the costs 

and bene !its of a regulation where there is no statutory bar to doing so is arbitrary and capricious. 

·'"Nat' I Research Council. Health Risks from Dioxin and Related Compounds: Evaluation of the EPA 

Reassessment ( 2006 ). https://w\vw.nap.edu/catalog/11688/health-risks-Ji·om-dio.xin-and-related-compoundsevaluation-of.·the. 

101 
181 


33371.163

The proposed rule entirely fails to comply with the requirements of non-arbitrary-andcapricious rulemaking because it fails to disclose, much less analyze or consider, any of the costs 

of the rule; barely discusses and does not analyze or quantify the benefits; does not provide any 

reasoned explanation of why the benefits of the rule justify its costs; and does not consider 

potential alternatives. The Proposal's discussion of costs and benefits is a scant two 

paragraphs459 (and was apparently not included at all in the version sent to the Office of 

Management and Budget).460 The proposed rule begins by conclusorily asserting that "EPA 

believes the benefits of this proposed rule justifY the costs."461 It then briefly discusses the 

perceived benefits, incorrectly suggesting that the National Academy of Sciences shares EPA's 

view by citing to a publication that discusses both risks and opportunities of expanding access to 

research data, and does not discuss at all the costs and benefits of ignoring relevant science in 

regulatory decisionmaking_462 It then merely states that the "action should be implemented in a 

cost-effective manner." citing vaguely to "recent activities of the scientific community and other 

federal agencies" without any concrete examples or analysis_463 The preamble's discussion 

emphasizes that the Proposal does not compel EPA to make information available where it 

concludes that doing so is not possible, but omits that if compliance is not possible, EPA will not 

consider the study, which has its own costs. It then concludes by citing the working paper of the 

Mercatus Ccnter464 that baldly asserts that improvements in reproducibility "can be thought of as 

increasing the net benefits of regulation b(~cause they would avoid situations in which costs or 

benefits are wrongly estimated to occur or in which regulatory costs are imposed without 

corresponding benefits."465 Setting aside the lack of substantiation for this assertion, it entirely 

omits situations in which costs and benefits are wrongly estimated because the relevant science is 

not used-and the costs that would be imposed on society if EPA inadequately protects 

communities from harmful pollution or toxic exposures. 

Indeed, the Proposal nowhere discllsses its significant costs in either quantitative or 

qualitative terms, costs that have actually been examined by independent organizations, and that 

are susceptible to analysis. If the Proposal is truly ''designed to provide a mechanism to increase 

access to" data "in a manner consistent with statutory requirements for protection of privacy and 

confidentiality of research participants," 83 Fed. Reg. at 18,770, then it will have significant 

costs. And if, as it appears, the Proposal's true "mechanism" is excluding science from 

regulatory decisionmaking, its costs will be even greater in the form of insufficiently protective 

regulations. 

Proposed Rule. 83 Fed. Reg. at 18.772. 

"'° Cumpw·e. EO 12866 Proposal 2080-AA 14 OIRA Conclusion Document (Docket II). No. EPA-HQ-OA-2018-

0259-0006) with EO 12866 Proposal 2080-AA 14 OIRA Review Start Document (Docket I D. No. EPA-IIQ-OA20 18-0259-0007). 

"'' Proposed Rule. 83 Fed. Reg. at 18.772. ·160 /d. 

4.61/d. 

464 For a proposal allegedly aimed at increasing transparency, it is notable that EPA does not disclose that Charles 

Koch-an outspoken opponent of public health protections who stands to gain financially from deregulation-is a 

board member of the Mercatus Center. Mercatus Center, Charles Koch, https://www.mercatus.org/charles-koch (last 

accessed: Aug. I. 2018). 

'"'Proposed Rule. 83 Fed. Reg. at 18.772. 

102 
182 


33371.164

If it were not possible to quantify and monetize any of the costs, which is not the case 

here as discussed below, EPA would still be required under E.O. 12866 and the requirements of 

rational rulemaking to identify and discuss the qualitative costs of this Proposal. It is inherently 

irrational for an agency to take an action without any consideration of any costs, disadvantages 

or negative effects of that action. The qualitative costs of this Proposal include the costs to 

researchers of actions they must undertake to protect the confidentiality of patient and subject 

data, as well as to compile and make public their raw data. and the potential loss of subjects (and 

attendant damage to research efTorts and results) due to confidentiality concerns. There are also 

various costs to the agency of administering the regulation. which include contacting researchers. 

gathering data, ensuring that patient confidentiality and confidential business information are not 

disclosed. Additional costs could also be incurred through conducting any additional peer 

reviews required by proposed section 30.7 and any additional analyses imposed by proposed 

section 30.6's requirement that "EPA shall clearly explain the scientific basis for each model 

assumption used and present analyses showing the sensitivity of the modeled results to 

alternative assumptions." Most importantly, there are potentially huge costs of regulating without 

using the relevant science merely because the underlying raw data is not publicly available. If 

studies supporting a stronger standard are excluded and EPA can there tore only justify a weaker 

requirement that leaves large numbers of people at risk of health effects from a pollutant, 

pesticide, or chemical, then this Proposal could impose enormous costs for each insufficiently 

protective regulation. 466 Y ct the Proposal fails even to mention these costs. let alone discuss their 

scope and significance. 

In addition, many of these costs can be quantified and monetized, but EPA has neither 

attempted to do so nor explained why it could not. For example, EPA has extensive information 

available to it on what the agency would need to do to implement this Proposal and how much 

those activities would cost. In fact, EPA already gathered much of this data and provided it to the 

Congressional Budget Office for use in estimating the costs of a similar (though not identical) 

proposal from Congress, the HONEST Act. With respect to the Congressional proposal, CBO 

concluded, just with respect to the costs to EPA, that ·'based on information from the EPA and 

other federal agencies, as well as organizations and researchers in the scientific community that 

publish in peer-reviewed journals." EPA "could spend between a few million dollars per year to 

more than one hundred million dollars per year ... to ensure that data and other information 

underlying studies are publicly available in a format sufficient to allow others to substantially 

reproduce the results of studies."467 In the 2017 estimate. CBO concluded that "(i]fthc EPA 

continued to rely on as many scientific studies as it has used in recent years ... then CBO 

466 In l(lotnote 3 of the Proposal. Proposed Rule. 83 Fed. Reg. at 18.769. EPA suggests that the studies underlying 

the NAAQS for particulate matter. at issue in the case cited-Am. Truckinf( Ass'ns v. FYA. 2R3 F.3d 355.358 (D.C. 

Cir. 2002}-are an example of data the agency would be "preclude[d]" !rom using in the future. The benefits of 

these NAAQS included up to $75.100 million in annual benefits from avoided cases of mortality in 2010 alone for a 

partial attainment scenario. National Research Council (US) Committee. Estimatinf( the Hea/th-Risk-lieduction 

Benefits of Proposed Air Pollution Regulations. 43 

National Academies Press (2002). https:i/www.ncbi.nlm.nih.gov/books/NBK22l0281. 467 Congressional Budget Cost Estimate tor H.R. 1430. Honest and Open New EPA Science Treatment (HONEST) 

Act of20l7 (Mar. 29. 2017) ("2017 CBO Estimate"); see also Congressional Budget Ofticc Cost Estimate. S. 544. 

Secret Science Ret(wm Act of 2015 (June 5. 20 15) (estimating that another similar congressional proposal would 

cost up to $250 million per year). 

103 
183 


33371.165

estimates that the agency would need to spend at least $100 million dollars per year to upgrade 

the format and availability of those studies' data," "on average, $10,000 per scientific study."468 

Such costs would cover the costs of"obtaining all the underlying data used in a study, reviewing 

the data to address any confidentiality concerns, formatting the data for public access, providing 

access to the computer codes and models used in the study's analysis, and providing descriptions 

and documentation on how to access the data."469 Notably, this does not include the cost to 

researchers to engage in this effort. As Deputy Assistant Administrator Nancy Beck noted, 

during the development of the Proposal, requiring "a huge amount of data to be submitted to the 

agency" would "be incredibly burdensome" and "not practical."470 

Even the Mercatus working paper--apparently the only thing EPA relied upon in 

discussing the costs and benefits of the Proposal, 83 Fed. Reg. 18,772 n. 24, notes, with respect 

to the HONEST Act, that "[t]he cost of providing access to data has been one of the primary 

concerns about requiring access to data used by the federal government."471 Far from concluding, 

as the Proposal suggests, an increase in net bcnetits from greater reproducibility, the Mercatus 

working paper simply explained a figure the authors were suggesting could be calculated (the 

point where net benefits would be positiv('); the authors do not themselves calculate the benefits, 

and admit that their "estimates of the benefits of public access to data supporting federal 

regulatory decisions fall short of proving that the benefits outweigh the associated costs."472 And 

while the Mercatus working paper disagrees with CBO's cost estimates, it does not argue that 

that requiring access to data is cost-less; indeed, it discusses the "costly activities and services 

that need to be performed," including activities related to "data collection and data 

accessibility.''473 According to that working paper, data collection requires "correspond[ing] with 

researchers and publishers to obtain the data, revicw[ing] the data for confidentiality concerns, 

fonnat[ting] the data for public access, publicly post[ing] the computer code and models used in 

each study's analysis, and provid[ing] descriptions and documentation on how to obtain the 

date.''474 Data accessibility requires "computer processing services to construct and maintain data 

bases to store study-related information."475 While the actual calculations put forward by the 

Mercatus working paper appear faulty (for example, it entirely omits the cost to researchers to 

compile and make their data public, does not include the costs of ensuring patient privacy is 

protected,476 and makes assumptions about the similarity of a chemical manufacturer collecting 

its own studies and EPA collecting and disseminating information of other researchers), the 

working paper at least acknowledges that there are costs, something EPA's Proposal completely 

ignores. 

·

168 2017 CBO Estimate at 3 ,)(,C) ld 

470 Email from Nancy Beck to Richard Yamada (Jan. 31. 2018 2:51 PM). 471 Mercatus Working Paper 19. 172 /d at 27-29. 

"' !d at 20. ~74 fd 

"'!d at 20-21 (quoting CBO. "Cost Estimate. S. 544, Secret Science Reform Act of2015." June 5, 2015). 476 For example. this may require special archiving and access arrangements to limit data sharing. such as those in 

NIH data sharing plans, which NIH requires only for studies that receive more than $500~000 in federal funding in a 

year. NIH. Nlll [)ata Sharing Policy and Implementation Guidance. 

https://grants.nih.gov/grants/po!icy/data sharing/data sharing guidance.htm (last accessed Aug. 16, 2018). 

104 
184 


33371.166

Nor docs the proposed rule disclose the cost-highlighted on the very first page of a 

National Academy of Sciences (NAS) report on data access-that "perceived risks to privacy 

and confidentiality reduce survey participation," a cost that the NAS explains is "borne out by 

research."477 NAS explains that this "threatens the research enterprise itself, because concerns 

about privacy and confidentiality are among the reasons often given by potential respondents for 

refusing to participate in surveys, and those concerns have been shown to affect behavior as 

wcll. 478 The NAS panel emphasized: "Any confidentiality breach that became known would be 

likely to heighten such concerns and, correspondingly, reduce survey response rates. Efforts to 

increase researchers' access to data must, therefore, take into account the need to avoid 

increasing the actual and perceived risks of confidentiality breaches."479 The Proposal does not 

so much as discuss this potential cost. 

This confidentiality risk has a further cost: it affects the quality of the data collected. As 

the NAS explained: 

The reason for confidentiality pledges and for stringent procedures to prevent 

disclosure is that they improve the quality of data collected from individuals, 

households, and firms. It is essential that respondents believe they can provide 

accurate, complete information without any fear that the information will be 

disclosed inappropriately. Indeed, if the information was disclosed, harm might 

come to an individual respondent. 480 

The Proposal's only acknowledgment of this complex problem and cost is its statement that 

··EPA believes that concerns about access to confidential or private information can, in many 

cases, be addressed through the application of solutions commonly in usc across some parts of 

the Federal governmcnt.''481 Remarkably, EPA does not cite a single example of these common 

solutions, citing only vaguely to '·examples from the U.S. Department of Health and Human 

Services, National Institute of Standards and Technology, U.S. Department of Education, and the 

U.S. Census Bureau" and some hyper! inks not in the Proposal added to the docket almost a 

month into the comment period.'82 Accordingly, not only does the Proposal include no analysis 

of these alleged solutions and their costs and benefits, it does not even explain what the solutions 

are that EPA believes address this concern. 

And if EPA complies with the regulation not by spending the money to make data 

publicly available, and if the research community does not bear those costs itself, see 83 Fed. 

Reg. at 18,770-7! ("Nothing in the proposed rule compels the disclosure of any confidential or 

private information in a manner that violates applicable legal and ethical protections."), then it 

appears that EPA would simply ignore studies that do not comply with the regulation. See 83 

Fed. Reg. at 18,769 n. 3 ("EPA is proposing to exercise its discretionary authority to establish a 

4

n National Research Council, Expanding Access to Research Data: Reconciling Risks and Opportunities, vii 

National Academies Press (2005). 478 ld at 51; see also id. at 52-54 (describing the research supporting this risk). 47 q /d. at 51. 

4SO /d. 

481 83 Fed. Reg. at 18.770. 

480 /d. 

105 
185 


33371.167

policy that would preclude it from using s~ch data in future regulatory actions."). That course of 

action has its own significant costs, and EPA provides no analysis in the Proposal of the 

magnitude of studies that it has previously relied upon that it could no longer rely upon in 

regulating. See 2017 CBO Estimate ("EPA officials have explained to CBO that the agency 

would implement H.R. 1430 with minimal funding and generally would not disseminate 

information for the scientific studies that it uses to support covered actions. That approach to 

implementing the legislation would significantly reduce the number of studies that the agency 

relies on when issuing or proposing coven:d actions .... "). As the SAB noted in its May 12.2018 

letter, "[t]he proposed rule does not include any assessment of the impact of data restrictions on 

existing or future regulatory programs. Without access to the restricted data, regulatory programs 

could become more or less stringent than they otherwise would be, with consequences for both 

regulatory costs and benefits."483 

Likewise, EPA has included only a cursory mention of the expected qualitative benefits 

of the Proposal, with no discussion of the anticipated likelihood, scope, or impact of the 

suggested benefits, let alone any effort to quantify them, much less monetize them. EPA simply 

assumes that the Proposal will "improve the data and scientific quality of the Agency's actions 

and facilitate expanded data sharing an exploration of key data sets" without any analysis or 

evidence. In fact, as we have explained, the likely outcome of the Proposal is that it will degrade 

the data and scientific quality of the Agency's actions by ignoring relevant science simply 

because the underlying data is not publicly available. Moreover, EPA's finding is not consistent 

with the conclusions of the National Academies, as the Proposal suggests. As also explained 

above, the NAS report highlighted both the risks and benefits of making data publicly available 

and nowhere concluded that there were benefits to excluding data from the agency's regulatory 

decisions simply because the underlying data was not publicly available. Nor does the agency 

analyze how likely its Proposal is to actually facilitate expanded data sharing. and its main aim 

appears to be excluding science as it does not actually provide any funding, mechanisms, or best 

practices for sharing data. 

lt is more than ironic that EPA claims-without any data or analysis-that its Proposal 

will increase the net benefits of other regulations while it does nothing to actually consider the 

costs and benefits of the Proposal itself. Moreover, there is no reason to think that excluding 

relevant science merely because the underlying data is not publicly available would increase the 

net benefits of a regulation. For example, it appears that under the proposed rule EPA would 

exclude a peer-reviewed, published study whose conclusion had been reproduced based upon 

numerous different datasets (and whose underlying data, though not publicly available, had been 

reevaluated by outside experts), while including a study that had had no peer review, was not 

published, had no corroborating studies, and had not actually been replicated or reproduced, 

merely because the underlying data was made publicly available. That is simply not a recipe for 

more accurate decisionmaking. 

The proposed rule also violates the' APA and other statutes' requirements for reasoned 

decisionmaking by failing to consider any alternative approaches, much less their costs, here. 

This is particularly irrational in this context where it appears that many of the benefits sought by 

"'Memorandum fi·om Alison Cullen. Chair. SAB Work Group on EPA Planned Actions tor SAB Consideration of 

the Underlying Science to Members of the Chartered SAB and SAB Liaisons 3 i:v!ay IX. 2018). 

106 
186 


33371.168

EPA could be largely achieved with much less burdensome and costly approaches. A critical 

element of reasoned decision making is consideration of alternatives which are congruent with 

agencies' statutory responsibilities and objectives. Motor Vehicle Mfi·s. Ass'n v. State Farm Mut. 

Auto. lns. Co., 463 U.S. 29, 48,50 (1983) (safety agency acted arbitrarily in failing to consider 

alternative safety measures after rejecting passive restraints). EPA failed to consider other 

methods to ensure scientific robustness at the agency. For example. the SAB letter notes that 

''[t)he proposed rule fails to mention that there are various ways to assess the validity of prior 

epidemiologic studies without public access to data and analytic methods."484 The Proposal does 

not consider any alternatives to ensuring that studies are reliable even where the underlying data 

cannot be made public because of privacy or other concerns. 

Furthermore, by failing to consider costs and benefits, the Proposal contravenes 

Executive Order 12866. Executive Order 12866 requires agencies to assess the costs and benefits 

of proposed regulations and propose or adopt a regulation only upon a reasoned determination 

that the benefits justify the costs.485 For "significant regulatory actions," like the proposed rule, 

83 Fed. Reg. at 18,772. the agency must provide: 

(i) An assessment, including the underlying analysis, of benefits anticipated from 

the regulatory action (such as, but not limited to, the promotion of the efficient 

functioning of the economy and private markets, the enhancement of health and 

safety, the protection of the natural environment, and the elimination or reduction 

of discrimination or bias) together with, to the extent feasible, a quantification of 

those benefits; 

(ii) An assessment, including the underlying analysis, of costs anticipated from 

the regulatory action (such as, but not limited to, the direct cost both to the 

government in administering the regulation and to businesses and others in 

complying with the regulation, and any adverse effects on the efficient 

functioning of the economy, private markets (including productivity. 

employment, and competitiveness). health, safety, and the natural environment), 

together with. to the extent feasible, a quantification of those costs; and 

(iii) An assessment, including the underlying analysis, of costs and benefits of 

potentially effective and reasonably feasible alternatives to the planned regulation, 

identified by the agencies or the public (including improving the current 

regulation and reasonably viable nonregulatory actions), and an explanation why 

the planned regulatory action is preferable to the identified potential 

alternatives.<86 

mId at4 (pointing to the Health Effects Institute re-analysis of the Harvard Six Cities and American Cancer 

Society epidemiological studies). 

"'Exec. Order 12866 ~ l(b)(6)-(7) (Oct. 4. 1993). 486 Exec. Order 12866 * 6(a)(3)(C). 

107 
187 


33371.169

The agency must also make these assessments and analyses "available to the public."487 

Executive Order 13563 reaffirms these principles and requirements, explaining that agencies 

"must take into account benefits and costs, both quantitative and qualitative."488 

Agencies are further encouraged to weigh the costs and benefits of developing higher 

information quality in OMB 's Information Quality Guidelines.489 Costs that the Guidelines 

encourage agencies to consider include "costs attributable to agency processing effort, 

respondent burden, maintenance of needed privacy, and assurances of suitable 

confidentiality.''490 EPA's existing information quality guidelines track the OMB Guidelines 

closely. EPA's disregard of the Guidelines' recommended weighing costs and benefits further 

contributes to the arbitrariness of EPA's failure to consider the costs of the Proposal. 

The Proposal's failure to analyze and disclose costs and benefits cannot be cured in a 

final regulation. Should EPA not abandon this misguided Proposal. it must re-propose it after 

first analyzing its costs (both to public health, to researchers, and to the agency itself) and 

benefits, and providing the requisite opportunity for public comment on its analysis. As 

discussed further below in Section VIII.D, the public cannot meaningfully comment on the 

proposed rule without understanding the actual costs and benefits of the Proposal, the 

alternatives EPA considered, and the analyses underlying EPA's assessments. 

VI. EPA Fails to Comply with the Paperwork Reduction Act. 

EPA and the White House Office of Management and Budget (OMB) must scrutinize the 

Proposal for its information collection burden, as that concept is defined under the Paperwork 

Reduction Act (PRA). 491 The only reference to the PRA in the Proposal is EPA's denial that this 

action "contain[s] any information collection activities" or "impose[s) an information collection 

burden''49' But if finalized, the Proposal would significantly increase that burden in the 

rulemakings to which it applies. EPA and OMB cannot rationally ignore such an entirely 

foreseeable impact when considering this Proposal. 

The PRA institutes procedural safeguards to "minimize the paperwork burden for 

individuals, small business, educational and nonprofit institutions,'' and others.''" It requires that. 

prior to initiating a "collection of information." agencies must "provide 60-day notice in the 

Federal Register ... to solicit comment to," inter alia, ·'evaluate whether the proposed collection 

ofinfonnation is necessary for the proper performance of the functions of the agency," "evaluate 

the accuracy ofthe agency's estimate of the burden of the proposed collection of information," 

'''Exec. Order 12.866 9 6(a)(3)(E)(i). 

"'Exec. Order 13563 § 1(a) (.Jan. 18. 2011). 430 OMB, Guidelines for Ensuring and ,\faxirni:hlg the Quality, Objectivi(v, l!tifity. and Integrity of lt!formation 

Disseminated by Federal Agencies, Repuh/ication.. 67 Fed. Reg. 8452. 8453 (Feb. 22, 2002). 

-'~ 90 OMH. Guide/;nesfor Ensuring and Afaximi:ing the Quality, Objectivity, Utility, and integrity of information 

Dissemina!ed by Federal Agencies: Repub/icalion, 67 Fed. Reg. 8452. 8453 (Feb. 22. 2002). 

·Nl See 44 U.S.C. § 3502(2). (3) (delining "burden" and "collection ofinfi>rmation"). 

See 83 Fed. Reg. at 18.772. 

'''3 44 u.s.c. § 3501(1). 

108 
188 


33371.170

and "minimize the burden of the collection of the information on those who are to respond."494 

After evaluating public comments, agencies must submit the proposed collection of information 

to OMB for additional review and publish a notice in the Federal Register setting forth "an 

estimate of the burden that shall result from the collection of information'' and "notice that 

comments may he submitted to the agency and [OMB]."495 Any such collection of information is 

subject to OMB approvaL496 OMB is required to determine "whether the collection of 

information ... is necessary for the proper performance of the functions of the agency."497 A 

negative determination precludes the agency from initiating the collection ofinfonnation.m 

The requirements that EPA would impose through this Proposal quality as collections of 

information under the PRA. The statute defines "collection of information" to include "the 

obtaining [or] causing to be obtained ... of facts or opinions by or for an agency, regardless of 

form or format, calling for ... answers to identical questions posed to, or identical reporting or 

recordkeeping requirements imposed on, ten or more persons ... .''499 OMB regulations 

emphasize the breadth of this delinition, specifying that ''[a] Collection of information may be in 

any form or format, including ... reporting or recordkeeping requirements; ... policy 

statements; ... rules or regulations; ... oral communications;" and others.500 "Any 

record keeping, reporting, or disclosure requirement contained in a rule of general applicability is 

deemed to involve ten or more persons."501 The definition of"collcction of information" is 

agnostic as to whether disclosure is "mandatory, voluntary, or required to obtain or retain a 

benefit," and to whether disclosure is to an agency or "members of the public or the public at 

large.'·502 

The Proposal would impose a burden that falls squarely within the definition of 

"collection of information." In order to use scientilic research, the agency would "obtain[] or 

caus[e] to be obtained ... facts." Assuming the requirements are applied consistently, the 

"questions posed;' or ''reporting or recordkeeping requirements imposed," would be "identicaL" 

As the requirements are ''contained in a rule of general applicability"-i.e., the instant 

Proposal-they are "deemed to involve ten or more persons." It makes no difference whether the 

agency seeks the information through a questionnaire. telephone call, or some other fonnat. Nor 

does it matter whether the agency directly mandates that entities provide the information, or 

provides that entities must "voluntary[ily]" provide the information in order for research to be 

eligible lor consideration in important rulemakings. 

While EPA has refrained from detailing the mechanics by which entities would provide 

the information, the agency expressly contemplates that the burden of providing such 

information would fall at least partly to members of the public whom the PRA exists to 

4

'" 44 U.S.C. § 3506(c)(2)(i), (ii). (iv). 

'"!d.§ 3507(a)(I)(D)(ii)(V). (VI). 496 See id. § 3507(o)(2). 491 Jd § 3508 . . ~()8 !d. ' 

4

'''' 44 U.S.C. § 3502(3)(A)(i). 500 5 C.F.R. § 1320.3(c)( 1). 

"' ld § !320.3(c)(4)(i). 

"" ld § l320.3(c). (c)(2). 

109 
189 


33371.171

protect.503 For example, proposed regulation 40 C.F.R. § 30.5 provides that, "[w]bere data is 

controlled by third parties, EPA shall work with those parties to endeavor to make the data 

available in a manner that complies with this section." Moreover, the agency specifically 

"solicits comment on how to incorporate stronger data and model access requirements in the 

terms and conditions of cooperative agreements and grants."504 As noted above, the PRA is 

implicated when collection of information is "required to obtain or retain a benefit,"505 and OMB 

guidance has identified grants as a "Federal benefit" for purposes of the PRA. 506 

EPA cannot evade the PRA requin:ments by narrowly asserting that "this action" imposes 

no information collection burden and ignoring the action's entirely foreseeable future impacts. 

The proposal expressly "is intended to apply prospectively," suggesting that it "prospectively" 

requires burdensome collections of information in future rulemakings. EPA must not ignore the 

PRA in this rulemaking, only to claim in future rulemakings that this rule moots or constrains the 

PRA's application by compelling certain collections of information. 

In the alternative, if EPA genuinely believes that this Proposal would not burden the 

public with new collections of information, then EPA's stated basis for this rulemaking is 

exposed as a farce. EPA claims that the Proposal would "ensure" that certain data "are publicly 

available" and expresses specific concern for science "developed outside the agency."st" 

Collection of information, including from researchers employed outside of the federal 

government, is central to the purpose-and essential to the implementation-of the Proposal. 

Providing this information would inevitably impose a burden on researchers. If the agency does 

not actually intend to collect information under this Proposal, it underscores that EPA's true 

purpose is not to increase transparency, but rather to thwart the development and maintenance of 

vital public health protections on the grounds that the agency lacks the information it would need 

to support them. 

At a minimum, EPA must acknowledge and describe the information collection burden 

that this Proposal would impose so that OMB and the public can conduct a proper evaluation and 

provide responsive comments. 

VII. The Circumstances Surrounding the Proposed Rule Indicate that it Was Based on a Desire 

to Suppress Vital Public Health Science for the Benefit of Certain Regulated Industries. 

The circumstances surrounding the development of this proposed rule underscore that it 

is not intended to "strengthen the transparency of EPA regulatory science."s<ls Far from 

furthering EPA's mission of protecting human health and the environment based on the best 

available science, the Proposal is EPA's effort to implement tailed congressional legislation that 

503 Cf id § 1320.3(k) (defining "person" tor purposes of the PRA). 504 83 Fed. Reg. at 18.77!. 505 5 C.F.R. ~ 1320.3(c). 50c' .)'ee Memorandum from Cass R. Sunstein. Administrator, Office orin fOrmation and Regulatoty Affairs. re: 

Information Collection Under the Paperwork Reduction Act J (Apr. 7. 20 I 0). available at 

www. \Vh i tehouse. g:ov/s i tes;\vh itehouse.gov /files/om b/assets/i nforeg/PRAPrimer 0407 20 1 0. pdf. 

5° 7 83 Fed. Reg. at 18.768. 18770. 508 83 Fed. Reg. 18.768. 

110 
190 


33371.172

was intended to suppress rigorous science for the benefit of private industry and at the expense of 

public health. 

EPA's Proposal is largely based upon the HONEST Act of20 17, an unenacted House bill 

that aimed at undermining climate and regulatory science. Available information about the 

Proposal's evolution indicates that regulated industries had a disproportionate role in its 

development. In addition, the Proposal mirrors advocacy tactics employed by the tobacco 

industry in the 1990's in order to suppress scientific research demonstrating the adverse health 

effects of cigarettes and second-hand smoke. Finally, the Proposal follows a host of instances in 

which the Agency, under former EPA Administrator Scott Pruitt, suppressed science and 

transparency-underscoring the bad faith nature of the purported justifications for this rule. 

A. The Proposed Rule is an Attempt by EPA to Implement an Unenacted 

Congressional Bill, The HONEST Act. 

EPA's Proposal is an outgrowth of a failed congressional bill, the HONEST Act. The bill 

was vigorously supported by Congress members with strong ties to the precise industries that 

would have benefited from its enactment. Internal and external EPA communications illustrate 

that the HONEST Act served as a precursor to EPA's Proposal. The intertwined history of the 

HONEST Act and EPA's Proposal cast doubt on the Agency's protTered rationale. 

The HONEST Act 

The HONEST Act509 is a House bill introduced in 2017 by sponsor Representative Lamar 

Smith (R-TX), and is the latest manifestation of various bills aimed at undermining EPA 

regulation through limitations on the types of scientific research the Agency may use510 The 

HONEST Act and these related bills were introduced and passed in the House three times, but 

each time, failed to progress in the Senate.511 

Like the current Proposal, the HONEST Act was touted by its proponents as an effort to 

enhance the transparency and credibility of regulatory science at EPA. But the HONEST Actlike the Proposal-would in fact have had the effect of limiting the scope and quality of science 

underlying EPA actions. Indeed the HONEST Act was widely criticized and opposed by 

scientists, scientific organizations. medical organizations and other scientific authorities for 

precisely this reason. For example, eight public health and medical associations including the 

American Lung Association, American Public Health Association, National Medical 

Association, and Physicians for Social Responsibility issued an open letter to Congress in spring 

2017 opposing the HONEST Act because it "would limit the kinds of scientific data EPA can use 

5

()Q HONEST Act. H.R. 1430. !15th Cong. (2017). 510 See Secret Science Reti:Jrm Act of2014. H.R. 4012, !13th Con g. (2014); Secret Science Reti:Jrm Act of 2015. 

II.R. I 030. I 14th Con g. (2015); li.R. 1430; liON EST Act. S. 1794. !15th Con g. (20 17). 511 On March 2017. Representative Smith introduced the HONEST Act in the !15th Congress. On March 29. 2017. 

the bill passed the House without amendment. Most recently, Senator Mike Rounds (R-SD) introduced a Senate 

version ofthe HONEST Act on September 12.2017. As with past versions of the bill, the Senate referred the Bill to 

the Committee on Envinmment and Public Works. hut took no further action. 

Ill 
191 


33371.173

as it develops policy to protect the American public from environmental exposures and permit 

violation of patient confidentiality."512 Th1e American Association for the Advancement of 

Science and twenty-two other leading scientific organizations and research universities likewise 

sent a letter to House Majority Whip Kevin McCarthy in March 2017 opposing the bill and 

warning that it could lead to a "situation where the EPA would be prevented from using the best 

available science and disseminating public information in a timely fashion."513 As we have noted 

elsewhere in these comments, the Congressional Budget Office- after consulting with EPA staff 

likewise concluded that the HONEST Act would "significantly reduce the number of studies 

that the agency relies on when issuing or proposing covered actions."514 

That the HONEST Act would suppress rather than promote good science at EPA is not 

surprising, given that the sponsors ofthe HONEST Act have a history of rejecting established 

climate science and strong ties to industries that would benefit from limiting the role of science 

in EPA rulemakings. Representative Lamar Smith is widely known as an opponent of 

mainstream climate science and public health and environmental safeguards.515 In a July 24, 

2017 opinion piece, Representative Smith lauded the benefits of increased atmospheric carbon 

dioxide: "A higher concentration of carbon dioxide in our atmosphere would aid photosynthesis, 

which in turn contributes to increased plant growth." 516 Smith and the sponsor of the Senate 

version, Mike Rounds, also receive substantial contributions from the same industries that will 

benefit from the proposal. 517 

512 Letter from Alliance of Nurses tOr Health Environments, Americnn Lung Association. American Puhlic Health 

Association. American Thoracic Society. Asthma and Allergy Foundation of America. Health Care Without Harm. 

National Medical Association. and Physicians for Social Responsibility to U.S. House (Mar. 27. 2017). 

http://www.lung.org/assets/Qocuments/advocacy-archive/letter-to-us-housc~opposing-2.pdf. 

513 Letter tl·om American Association for the Advancement of Science et al. to Rep. Kevin McCarthy (Mar. 28, 

20 17). https://mcmprodaaas.s3 .amazonaws.com/s3 Ispub I ic/HR %20 14 3 0%20 H 0 NE ST%20A ct%20 Multi societv%20 Lctter%20of%2 OC onccrn. pdf. 514 CBO. H.R. 1430, Honest and Open New EPA Science Treatment (HONEST) Act of2017 at 2 (Mar. 29, 2017). 

hllps:!/www. cbo. gor/svstemlfi/es ?tile'"" 1 /Sth-congress-2{) 17-20 /8/costes·timate/hr 1-IJO.pdf 515 See. e.g. Rep. Lamar Smith. Climate Change: Se!'en Indisputable Facts, The Hill (Sept. 8. 2017.5:46 PM). 

http://thehill.comiopinioniop-ed/252989-climate-change-scven-indisputable-facts (''Like all climate alarmists. the 

president wants Americans to believe there is no uncertainty about climate changc .... But the truth is there arc more 

questions about climate change than there are answers. For instance. even the most advanced climate models all 

!ailed to predict the lack of warming the Emth has experienced over the last 18 years."); Lamar Smith. The Climate 

Change Religion. The Wall Street Journal: Opinion! Commentary (Apr. 23.2015.7:35 PM). 

https://www.wsj.com/articles/the-climate-change-religion-1429832149. (''When assessing climate change. we 

should fOcus on good science, not politically correct science."): Lamar Smith. Smith: EPA Hides Truth about 

Climate Regulations. Media Center: Press Releases (Aug. 13. 2014). https:/ilamarsmith.house.gov/mediaccnter/press-releases/smith-epa-hides-truth-about-climate-regulations. 

516 Lamar Smith. Don't Believe the f~vsteria over Carbon. The Daily Signal Energy: Commentary (July 24, 2017). 

h ttps:/ /www.dai ly signa 1. com/2 0 1 7/07/24/ Liont -believe-hvsteria-carbon-d ioxide/ 517 Throughout his congressional career, Represcnlativc Smith received over $787.047 in contributions from the oil 

and gas sector. Center for Responsive Politics. Rep. Lamar Smith Texas Distr;Cl 21: Summary. Open Secrets: 

Congress. https://vvww.opensecrets.org/membcrs-ofCcongress/summary?cid~NOOOO 1811 &cvcle~CAREER&type~J 

(last visited June 6. 2018). From 2011 to 2018. Senator Rounds received over $215.000 ti·om oil and gas companies 

nlone. Center fOr Responsive Politics. Sen Alike Rounds- South Dakota: Surnmwy. Open Secrets: Congress. 

https:l/www.opensecrcts.org/mcmbcrs-o kongresslsummary?cid~N0003 5187 &cvclc~CAREER&type~r (last 

visited June 14. 2018). 

112 
192 


33371.174

Representative Smith also has ties to EPA staff who drafted the proposal, underscoring 

the close connection between his failed legislation and this proposed rule. Dr. Richard Yamada. 

rormer professional statTmember on Smith's House Committee on Science, Space & 

Technology now serves as the Deputy Assistant Administrator for EPA's Office of Research and 

Development. 518 At EPA, Dr. Yamada has participated in the drafting and development of the 

Agency's version of the proposa1. 519 

The HONEST Act as Predecessor for the Proposal 

As this section details, it is clear that the HONEST Act is a direct predecessor of this 

proposed rule and that both initiatives share the same purpose: to undermine EPA's use of 

rigorous science in crafting health and environmental protections. The language used in the 

proposal shares strong similarities with the HONEST Act. Furthermore, internal and external 

communications from EPA leadership demonstrate the proposal's origins in the HONEST Act. 

While lengthier than the congressional HONEST Act, EPA's proposal contains parallel 

language to the bill. One can compare examples from the text of the 2017 HONEST Act as 

passed in the House, to the text of the proposal from the Final l'ederal Register Notice: 

The HONEST Act of2017 

An Act: To prohibit the [EPA] from proposing, finalizing, or disseminating regulations or 

assessments based upon science that is not transparent or reproducible ..... 

The Administrator shall not proposed, finalize, or disseminate a covered action unless all 

scientific and technical information relied on to support such covered action is--( A) the 

best available science: (B) specifically identified; and (C) publicly available online in a 

manner that is sufficient for independent analysis and substantial reproduction of search 

results ... 520 

Strengthening Transparency in Regulatm:v Science Proposal 

EPA shall clearly identify all studies (or other regulatory science) relied upon when it 

takes any final action. EPA should make all studies available to the public to the extent 

practicable ... When promulgating significant regulatory actions, the Agency shall 

ensure that dose response data and models underlying pivotal regulatory science are 

publicly available in a manner surficient for independent validation. 521 

518 EPA, Dr. !iichard ramada. EPA Research. h!!Qs://www.epa.gov/research/dr-richard-yamada. (last updated Jan. 

12. 20[8). 519 Email from Richard Yamada. Dcptuy Assistant Adm'r, Office ofRescarh and Dev .. to Drew Feeley, Policy 

Counsel, Office of Policy; Brittany Bolen, Acting Assoc. Adm'r. Ofticc of Policy: Clint Woods. Deputy Assiswnt 

Adm'r. Office of Air and Radiation: Justin Schwab, Deputy Gen. CounseL Office of Gen. Counsel; Erik Baptist. 

Senior Deputy Gen. Counsel, Otlice of Gen. Counsel; and Nancy Beck. Deputy Assistant Adm'r. Office ofChcm. 

Safety and Pollution Prevention (Jan. 29.2019. 10:58 PM), 

https:/ldrive.google.com/tile/d/l peMXj Bhq61UYGGNB WbSjpOu I Zh-qLI4pl. 510 H.R.I430§ 2(b)(1). 

"'Strengthening Transparency in Regulatory Science. 83 Fed. Reg. 18,768. 18,773 (Apr. 30. 2018) (proposed 40 

C.F.R. §§ 30.4. 30.5). 

113 
193 


33371.175

The best available science must serve as the foundation of EPA's regulatory actions. 522 

Responsive records released to the Union of Concerned Scientists ("UCS") make evident 

that the HONEST Act served a predecessor to the proposal. Administrator Pruitt's schedule 

reveals that he met with Representative Smith on January 9, 2018, less than four months before 

the Federal Register announcement of the proposal.523 Emails from Pruitt and his staff, dated just 

over a week after that meeting, indicate that Smith was working on a "pitch that EPA internally 

implement the HONEST Act."524 Subsequent emails sent between Pruilt's EPA staff in February 

2018 demonstrate that EPA officials promptly began drafting the proposal. 525 

Before Smith's internal EPA 'pitch,' Agency leadership commented favorably on the 

HONEST Act of2017. Although EPA initially estimated that implementation of the act would 

cost over $250 million per year, 526 that estimate was never reported to the Congressional Budget 

Office ("CBO"). As CBO's cost estimate determination indicates, EPA political leadership 

diverged from the earlier estimate and instead assured CBO that the bill could be implemented 

''with minimal funding."527 Severa! news sources have reported that the Administrator's Office 

ofthe EPA became involved in communications with CBO, and decided to respond to CBO 

directly with the assurance the bill could be implemented at 'no cost.' 528 

Finally. in an exclusive interview with the Daily Caller shortly before the proposal's 

publication, former Administrator Pruitt promised: 

520 ld. at 18.769. 

EPA. Calendar for Scott Pruitt, Administrator, Senior Leaders Calendars. https://archive.epa.gov/epa/seniorlcadcrs-calendars/calendar-scott-pruitt-former-administrator.html (last visited Aug. 3, 20 18) (search starting point 

lield lor "Smith." then see entrv for .Jan. 9, 2018). 524 Email fi·om Aaron Ringel. 6eputy Assoc. Adm ·r. Office of Intergovernmental Affairs. to Troy Lyons. Assoc. 

Adn1.L Office of Congressional and Intergovernmental Relations; David Fotouhi. Deputy Gen. Counsel, Office of 

Gen. Counsel: Mandy Gunasekara. Principal Deputy Assistant Adm'r. Office of Air and Radiation: and Rich<1rd 

Yamada. Deputy Assistant Adm'r, Office of Research and Dev. (Jan. 16.2018.2:28 PM)( on file with Union of 

Concerned Scientists). https://drive.google.com/tile/d/15Z6RKok51ugwkgAmhK3rseTOEJhfo8Sj/. 

'"See. e.g., Email fl·om Richard Yamada, Deputy Assistant Adm'r, Office of Research and Dcv .. to Nancy Beck, 

Deputy Assistant Adm'r, Office ofChcm. Safety and Pollution Prevention (Jan. 29,2018,6:07 PM)( on file with 

Union of Concerned Scientists). https://drive.google.com/tile/d/1 DvwXyjzZIPstQx3tVL-jW Yjv-S7VD2H/; Email 

ii·om Richard Yamada, Deputy Assistant Adm'r, Office of Research and Dev .. to Drew Feeley. Policy Counsel. 

Ofllce of Policy; Brittany Bolen. Acting Assoc. Adm'r. Oflice of Policy: Clint Woods. Deputy Assistant Adm'r, 

Oftice of Air and Radiation; Justin Schwab. Deputy Gen. Counsel, Oflicc of Gen. Counsel: Erik Baptist, Senior 

Deputy Gen. Counsel, Otlicc of Gen. Counsel; and Nancy Beck, Deputy Assistant Adm'r. Office ofChem. Safety 

and Pollution Prevention (Jan. 29,2019, 10:58 PM). 

https://drive.google.com/lile/d/lpeMXjBhq61UYGGNBWbSjp0uiZh-gLI4p/. 

""EPA. Comments on CBO Questions for EPA regarding H.R. xxxx. the HONEST Act of2017 (n.d.) (on tile with 

Bloomberg Bureau ofNational Aft~lirs}. http://src.bna.com/nAL 

CBO. Cost Estimate: H .R. 1430. Honest and Open New EPA Science Treatment (HONEST) Act of20 17 l 

12017). https:liwww.cbo.gov/svsteml!ilcs/1!5th-con"rcss-20 17-2018/costestimate/hr 1430.pdf. 

"'E.g. Scott Tong, Critics Say HONEST Act undercuts EPA's use of science, Marketplace: Sustainability (Apr. 10. 

20 17, 1 :08 PM}, https://www.marketplace.org/20 17/04/ l 0/sustainability/honest~act-seen-critics-undercutting-epa-susc-science. 

114 
194 


33371.176

If we use a third party to engage in scientific review or inquiry, and that's the basis of 

rulemaking, you and every American citizen across the country deserve to know what's 

the data, what's the methodology that was used to reach that conclusion that was the 

underpinning of what rules that were adopted by this agcncy. 519 

The Daily Caller directly linked the proposal to the HONEST Act, ''Pruitt's pending science 

transparency policy mirrors Smith's HONEST Act, which passed the House in March 2017.''530 

Spokeswoman for Chairman Smith's House Committee on Science, Space, and 

Technology, Thea McDonald. also told the Daily Caller: ·'[t)he chairman has long worked 

toward a more open and transparent rule-making process at EPA, and he looks forward to any 

announcement from Administrator Pruitt that would achieve that goal."531 

I. Available information on the development of the proposal illustrate its 

industry origins. 

The history of the proposal's internal development indicates that certain representatives 

of regulated industries had a nearly exclusive role in its promulgation, and that industry concerns 

were given special solicitude by EPA's senior political leadership. Meanwhile, the scientific 

community and the EPA's own Science Advisory Board were neither involved in the evolution 

of the proposal nor notified of its initiation until after its official publication in the Federal 

Register, further suggesting that this proposal is not grounded in a genuine concern for 

advancing science at EPA and is, in fact, at odds with EPA's mission of protecting human health 

and the environment. 

Nancy Beck, key decision maker and EPA's current Deputy Assistant Administrator of 

the Office of Chemical Safety and Pollution Prevention, previously served as the Senior 

Director, Regulatory & Technical Affairs for the American Chemistry Council. 532 While 

employed by the ACC, Beck submitted a written statement in general support of the HONEST 

Act. 533 

In internal EPA emails released pursuant to Union of Concerned Scientists' Freedom of 

Information Act ("FOIA") request, Beck expressed concerns that repeated those of industry. Her 

concerns that certain language in the proposal might compromise industry confidential business 

information ("CBI") or alter individual party adjudications were met with assurances by Deputy 

Assistant Administrator for the Office of Research and Development, Richard Yamada, that the 

529 Michael Bastach. Exclush·e.· Scoff Pruill Will End EPA's Use of'Secrel Science· lo Jusl(fy Regula/ions. The 

Daily Caller (Mar. 20. 2018. I :06 AM). http://dailycaller.com/20 18/03/19/epa-scott-pruitt-secrct-science/. 

5)0/d. 

51lJd 

510 Nancy Beck. Linkedln. https://www.linkedin.com/in/nancybbeck/ (last visited June 6. 2018). 5

'

3 Written Statement ojNanc.}' B. Beck Before the U.S Senate Committee on Homeland Securi(V and Governmental 

Affairs. Subcommillee on Regulatory Affairs and Federal Managemenl Regarding a Hearing on !he Agency Use of 

Science in the R11lemaking Process: Proposals for Improving Transparency and Accountability. American 

Chemistry Council I (Mar. 9. 2017). https://www.hsgac.senate.Qov/imo/mcdiaidoc/BECK%20TESTIMONY.pdf. 

115 
195 


33371.177

agency would "thread" the proposal "real tight."534 Concerns about protecting CBI. expressed in 

Beck's emails, echo her statement in support of the HONEST Act to the House Subcommittee on 

Regulatory AtTairs and Federal Management while she was employed by the ACC. 535 

The proposal's justifications regarding the private-sector burden of regulatory costs 

reiterates concerns and suggestions about EPA's policy for evaluating science that the Agency 

received from industry itself. In emails to EPA leadership from May 2014, the National 

Association of Manufacturers ("NAM") specifically identified dozens of EPA regulations that 

were "affecting its members," many of which were chemical, air, and water regulations which 

were based upon the types of research and studies that would be excluded under EPA's proposed 

rule536 

In response to EPA's 2017 proposed rule, Procedures for Prioritization of Chemicals for 

Risk Evaluations, NAM made recommendations that EPA ensure that TSCA prioritization relied 

upon ''the best available science" in a process that requires '·a heightened level of 

transparency.''537 NAM also provided the EPA with materials that called for reform of EPA's 

·'process for evaluating science to improve transparency and better involve the public."538 This 

parallels NAM's 2014letter to the House in support of that year's version of Rep. Smith's 

HONEST Act539 

The American Petroleum Institute's ("API") Senior Director of Regulatory and Scientific 

Affairs wrote to the EPA: "[t]he science and data used to support a regulation should be 

reviewed to determine if they are still valid based on scientific integrity, consistent with EPA's 

Principles of Scientific Integrity and Policy (2012). with meaningful disclosure of all potential 

areas of bias. guarding against manipulation or misinterpretation."540 

API also issued a press release on that same day, May 15, 2017, in which the 

organization summarized its conversations with EPA: "API today urged the EPA to adopt a 

53-1 Email fl·om Richard Yamada. Deputy Assistant Adm'r, Office of Research and Dcv., to Nancy Beck. Deputy 

Assistant Adm'r, Otlice of Chern. Safety and Pollution Prevention: Erik Baptist. Senior Deputy Gen. Counsel. 

Office of Gen. Counsel: and Justin Schwab. Deputy Gen. CounseL Office of Gen. Counsel {.ian. 31. 2018. 7:54 

I'M)(on tile with Union of Concerned Scientists), 

https://drive.goog1e.comillle/d/1 VIUUz2wDTT7c7oxBAU3gSPSIMlipie05/. 

'iJ'i American Chemistry CounciL supra note 34, at 7. 

\~~>Letter 1hm1 the Nat·! Ass·n oi' Mt:S. to Regulatory Reform Officer and Associate Administrator. Samantha K. 

Dra\'is (May 15. 20 17) in Maxine Josclow, /:)nails: EPA a/! ears as indusf/)1 pitched 'secret scienn.> ·, E&E Nc,vs: 

Regulations (May 18. 20 18). https:/lwww.eenews.net/greenwire/20 18/05/17/storiesil 060081997. at 169-88. 5

" hi. at 184. 

"'EPA Afeetill!i Briefing Paper. Nat'! Assn ofMts. (n.d.). in .loselow. at772-6. 53 ' Letter fi·om the Nat' I Ass'n ofMfs. to U.S. House of Representatives (Nov. 19. 2014) in Nat' I Ass'n ofMfs .. Key 

,\1am{{ac!Uring Votes: I 13th Congress, Advocacy: Congressional Voting Record, 

http://ww\v.nam.org/ Advocacv/Key-Manufacturing-Votes/ !13th-Congress/( lousc/H R-40 12--the-Sccrct-Sciencc~ 

Reti>rm-Act-of-20 14-sponsored-bv-Representative-Dave-SchweikerH R-AZ)I'' taxonomyid~211. (last visited June 

6, 2018). 540 Letter ti·om the Am. Petroleum lnst. to Regulatory Reform Officer and Associate Administrator. Samantha K. 

Dravis (May 15. 20 17) in Joselow. at 1140. 

116 
196 


33371.178

regulatory system that enhances safety and protects the environment while prioritizing the 

production and refining of American natural gas and oil."541 

In contrast, EPA's Science Advisory Board ("SAB'') leadership was not notified of the 

rulemaking activity until it was published in the Federal Register, in contravention of Agency 

practices for communicating major actions such as the proposed rule 542 EPA also failed to 

provide the SAB with a description of the proposal 543 

Despite the SAB's Congressionally-mandated role to formally review and comment on 

EPA actions of this nature, 544 the SAB and scientific community were not consulted in the 

development of the rule. 545 Indeed. SAB leadership questioned the scientific support behind the 

proposal: "[a]lthough the proposed rule cites several valuable publications that support enhanced 

transparency, the precise design of the rule appears to have hccn developed without a public 

process for soliciting input from the scientific community.''546 

SAB leadership took note of the HONEST Act's connection to the proposal, stating the 

rule was "highly controversial'' as indicated by the fact that "a similar legislative effort in the 

House has been stalled in Congress tor several years."547 

B. EPA's Proposed Rule Mirrors Policies That the Tobacco Industry Advocated 

for in the 1990's to Suppress Unfavorable Science, 

Both this proposed rule and the HONEST Act bear close similarities to policies promoted 

by the tobacco industry in the 1990's to suppress unfavorable science-further confirming that 

the proposed rule would degrade the quality of science at EPA and undermine public health. 

Before EPA's proposed rule and the HONEST Act, Philip Morris (today, Altria) and publicrelations firm APCO partnered to establish The Advancement of Sound Science Coalition 

("TASSC") in order to ·'inform the market of the problem with unsound science" that 

demonstrated adverse health effects of tobacco and second-hand smoke. 548 TASSC led a 

worldwide publicity campaign in the 1990s to promote "Good Epidemiological Practices" that 

S·tl Reid Porter. API: Regu/atOJ~V System Should Promote Technological Innovations and lndus/J~V Rest ?rae/ices~ 

Am. Petroleum Inst.: News (May 15. 2017). http://viww.api.org/ne\vs-policy-andissues/news/20 l7i05/l5/regulatorv-system-should-promote-technoL (la5t visited June 6. 20 18). 542 Memorandum trom Chair of the SAB Work Group on EPA Planned Actions f(>r SAB Consideration of the 

Underlying Science, Alison Cullen, to Members of the Chartered SAB and SAil Liaisons (May 12. 2018), 

https://yosemite.epa.gov/sablsabproduct.nsll/E21 FF A E956B548258525828C00808B B 7 /$File/WkGrp memo 2080 · 

AAI4 fmal 05132018.pdf. 54} !d. 

544 Environmental Research. Development, and Demonstration Authorization Act of 1978,42 U.S.C. * 4365 (1978). 145 Memorandum ti·mn Chair of the SAB Work Group on EPA Planned Actions tor SAB Consideration of the 

Underlying Science. Alison Cullen, to Members of the Chartered SAB and SAB Liaisons (Mav 12. 2018), 

https:/ lvosem ite .epa. "ov lsablsabprod uct. nslliE21 F FA E9 56B 5 4825 85 25 82 8C0080 81l B 7 /$F i leiWkGrp memo 2080-

AAI4 final 05132018.pdL 54h !d. 

'i47 !d. 

548 See APCO Assoes .. Revised Plan l(lr the Public Launching ofTASSC (Through 1993) (Oct. 15. 1993) (internal 

document) (on tile with UCSF. available online through Truth Tobacco Industry Documents portal). 

117 
197 


33371.179

aimed at undermining U.S. and international regulatory efforts based on epidemiologic studies of 

passive smoking and lung cancer.549 

During the same period, Philip Morris made it a strategic priority to pursue legislation 

and policies to require public disclosure of epidemiological data. A May 1997 planning 

document advocated for using "existing political and business coalitions" that opposed clean air 

regulations to promote "legislative solutions to ensure that public policy is based on sound 

science" and ·'require epidemiological studies to meet a minimum set of criteria and/or require 

researchers to make public the underlying data before these studies can be used as a basis for 

regulations at the state or federallevel."550 In 1998, Powell Tate- a lobbying firm that 

represented R.J. Reynolds organized a "secret science" working group focused on "requiring 

the disclosure of taxpayer-funded analytical data upon which federal and state rules and 

regulations are based, as well as the analytic data underlying health and safety studies funded by 

the government .... " 551 

Although TASSC no longer exists. its executive director, Steve Milloy, continues the 

organization's "sound science" rhetoric against other types of regulation through his website, 

JunkScience.com. 552 In fact, Milloy has personally taken credit for EPA's proposal and was one 

of a select few invited to Pruitt's public announcement of the proposal earlier this year. 553 After 

the proposed rule was announced, Milloy told reporters, "!look at this as one of my proudest 

achievements. The reason this is anywhere is because of Steve Milloy.''554 

C. EPA, Under the Trump Administration, Has a History Of Suppressing 

Science and Transparency, Undermining the Purported Justifications for the 

Proposal. 

A FOIA request submitted by E&E News uncovered a document cmailed by former EPA 

official David Schnare laying out a strategy to overturn the 2009 Greenhouse Gas Endangerment 

Finding. 555 In the document, one of the stc:ps contemplated as part of the reconsideration included 

EPA only relying ''on information, data and studies where the original data upon which assessment 

is based is available to the public .... EPA would not rely on any study whose authors refuse to 

549 Elisa K. Ong and Stanton A. Glantz, Constructing ··s·aund 5'cience" and "Good Epidemiology '. Tobacco, 

Lcmyers, and P~thlic Relations Firms. 91 Am . .1. o i' Public Health 1749. 1753 (200 I). 

:-so Annamaria Baba eta!.. Legislating "Sound Science" the Role of the Tobacco indus! I}'. 95 Am, l of Public 

Health S20, S22 (2005). 

"'Memorandum from Leslie Gianelli. Powell Tate, to "Secret Science" Work Group (Apr. 10, 1998). available at 

https://ww\V. ind ustrydocuments I i brary. ucsf. edu/tobaccoi docs/# i d-··""kl yc0069. 

"'Emily Atkin. The EPA is Acting Like Big Tobacco, The :-Jew Republic (Apr. 26, 2018). available at 

https://newrepubl ic.com/aJ1icle/J 48126/era-acting-1 ike-big-tobacco. 553 Robin Bra vender, Pruill to unveil 'secret science' ef!brl todaJ'·-sources~ E&E News: EPA (Apr. 24, 2018). 

htlps:l/www.eenews.net/storiesll 060079891. 554 Robin Bravcndcr. li'ump team wamed to kill agency authority on C02 -emails, E&E News (June I, 20 18). 

https:l/www.eenews.net/storiesll 060083175. 555 Document entitled GHG Endangerment Finding Redox. 

https:l/www.eenews.net/assets/20 18106/01/document cw 13.pdf. 

118 
198 


33371.180

provide the underlying data, including computer code used to evaluate and analyze the data." 556 

This is just one example among numerous others that this proceeding is not intended to increase 

transparency, but rather aimed at weakening EPA standards that the current Administration 

disapproves of, despite their grounding in robust scientific evidence. 

EPA's non-transparent approach to this rulemaking, as well as other Agency actions. 

underscore that the proposal was not offered in good faith. The Agency has removed thousands 

ofwebpages from its website. limited public and press access to Agency events, and withheld 

key data underlying rulemakings and proceedings. These practices cast doubt on EPA's 

proffered justifications of transparency and accountability. 

In EPA's stay of the Oil and Natural Gas Sector: Emissions Standards for New, 

Reconstructed, and Modified Sources, EPA failed to disclose directly relevant evidence for the 

basis of revision of the standards consisting of industry compliance reports. 557 Despite the fact 

that these compliance reports were in the agency's possession and comprised of public 

documents containing factual data that should have been available for public inspection, EPA has 

to date still not released all of the compliance reports in its possession. 

In August 2017, EDF received information pursuant a FOIA request revealing that more 

than 1,900 climate-related webpages and files on EPA's website were removed or modified.558 

Many of the removed and modified pages were related to climate change science and impacts, 

such as "Climate Impact on Health Through Life Stages," "Climate Change Science," and 

"Methane and Black Carbon Impacts on the Arctic: Communicating the Science."559 

In January 2018, EDF received additional responsive records to another FOIA request 

demonstrating that former Administrator Pruitt directed the removal of many climate change 

science, impacts, and resources pages as well as all material related to the Clean Power Plan on 

EPA.gov. 560 

556 Document entitled Gl IG Endangerment Finding Redux. 

https:llwww.eenews.net/assets/20 18106/0 1/document cw l3.pdf. 557 Comments of Clean Air CounciL Clean Air Task Force. Center for Biological Diversity. Earth justice. 

Earthworks. Environmental Defense Fund. Environmental Integrity Project. Environmental Law and Policy Center. 

Natural Resources Defense Council, Sierra Club. and National Parks Conservation Association on Oil and Natural 

Gas Sector: Emission Standards tl1r New. Reconstructed. and Modified Sources: Stay of Certain Requirements and 

Oil and Natural Gas Sector Emission Standards t<w Ne\v, Reconstructed. and Modified Sources: Three Month Stay 

of Certain Requirements Docket No. EPA-HQ-OAR-2010-0505 and Docket No. EPA-HQ-OAR-2017-0346 (Dec. 8. 

2017). 

558 Environmental Defense Fund Obtains !nj(>rnwtion on Over 1,900 Climate-Related Items Remol'edfrom or 

Modified on EPA Website. EDF: Press release archive (Aug. 11, 2017). https:l/wv\'w.edf.orglmedia!environmentaldefense~ f und-obtains-i ntOrmation-ovcr-1 900-cl i mat e-re I ated-items-removcd-or. 55'l Jd 

560 E-mail ti·om Lincoln Ferguson. Senior Advisor, Oftfce of Public Affairs, to Amy Graham, Advisor. Oftice of 

Public A flairs; John Konkus. Deputy Associate Administrator, Office of Public Affairs; JP Freier. Associate 

Administrator. Office of Public Affairs; Liz Bowman. Acting Associate Administrator. Office ofPub1ic Affairs: and 

Jahan Wilcox, Strategic Communications Advisor. Office of Public Affairs (Apr. 5, 2017, 4:15PM) in EDF, Newly 

Released Records Refer to Pruitt's Personal Jnvol1'ement in Removal a,( Climate /J?formationfrom EPA Website. 

EDF: Press release archive (Jan. 29. 2018). https:liwww.edf.org/sitesldefault!files/2018.01.05-nartialproduction.pdf. 

119 
199 


33371.181

At the same time, EPA was soliciting comments on its proposal to repeal the Clean 

Power Plan. The removal ofwebpages related to climate and Clean Power Plan topics from the 

EPA website restricted the public's ability to formulate informed comments throughout the 

rulemaking process. 561 Thus, the public lacked the same "access to data and influential scientific 

information used to inform federal regulation"56c which EPA claims to observe in its proposal. 

The Administration has not rigorously pursued its purported goal of transparency in other 

contexts by limiting public and press access to Agency events and withholding key data 

underlying several recent rulemaking proceedings. 

At the event where former Administrator Pruitt announced the proposal, reporters were 

not invited to attend.'"3 Documents received in response to a Sierra Club FOIA request to the 

EPA reveal that the Administrator had requested press access and advertisement to the public be 

limited for other events. 

For his speaking engagement at a Federalist Society event in March 2017, Pruitt's 

scheduling director asked that organizers not advertise to press directly and directed organized to 

tell media that the event "is not open to press and is off the record.''56' Emails also demonstrate 

that the Agency worked with a public relations firm to devise a plan to promote positive 

comments and censor negative comments on media from the Administrator's facility visits. 565 

EPA additionally failed to provide the public with access to data in key rulemakings and 

proceedings. For example, in EPA's rulemaking to repeal emissions requirements for glider 

vehicles, engines, and kits, commenced in November 2017. the Agency failed to release the 

underlying reports and data before the public comment period closed.566 At this date, EPA still 

has not released data used in a key study cited in the Agency's proposal. 

In the words of the proposal, EPA acted in contravention of its goals of''better informing 

the public," "enhancing the public's ability to understand and meaningfully participate in the 

56 ! Environmental Data & Governance Initiative on EPAls ProposaL Repeal ofCarhon Pollution Emiss;on 

Guidelines/or Existing Stationmy Sources: Electric Utility Generating Units. 82 Fed. Reg. 48.035 (Apr. 26. 2018). 

awli!ab/e at https://envirodatagov.org/edgi cpp proposed rule comments 042618/. 

"'' 83 Fed. Reg. 1RJ68. 18.768 (Apr. 30. 2018). 

Miranda Green, Pruitl signs proposed rule to erase ·secrer science 'from EPA. The }Iii! (Apr. 24. 20) 8. 2:40 

PM ). http ://theh ill. com/po 1 icv I energy -env iro nmemi3 8 46 3 6-pru itt -si gns-proposed-ru lc-to-erasc-sccrct -science-fromagenc\. 

'"Email !rom Juli Nix. Director of Conferences, Federalist Society. to Millan Hupp, Director of Scheduling and 

Advance. EPA (Mar. 17.2017. 12:30 PM)(on file with Sierra Club), 

https://www.Jocumentcloud.org/documents/4453 1 64-Pruitt-Sierra-Ciub-NYT-Foia.html#document/p29ia422141 . 

"'Email tram Gus Wagner. Partner and Creative Dir .. ARC Media. !(mvarded to £larry Hart, CEO, Nat' I Rural 

Electric Coop. Ass'n: Amy Graham. Dir. ofCommc'n, EPA: Tate £lennett, Assoc. Adm'r. Otftce of Public 

Engagement and Envvtl. Educ.; Joe Wilkinson. Sr. Vice Pres., Assoc. Electric Coop. (Apr. 18. 2017). 

sr,(, EDF Supplemental Comment on EPA's Proposed Rule, Repeal (l£mission Requirementsfbr Glider Vehicles, 

Glider Engines. and Glider Kits. 82 Fed. Reg. 53.442 (Mar. II. 2018). 

ht!ps.· · ·ww11·. edf orw~r;;ite s:'de faufl 1 tiles/ conte nt/ED F%2 0 Thi rd%2 OSuppleme ntal%2 OCom me nt%2 Ore %2 () TTU%2 OSt 

udv%2031 /.18.pd[ 

120 
200 


33371.182

regulatory process," and "ensur[ing] that its decision-making is marked by independence, 

transparency, clarity, and reproducibility" as it proceeded through rulemakings that ·'will affect 

the public" and where "the public is likely to bear the cost of compliance."51'

7 

VIII. The Proposal Violates Procedural Requirements of the APA, CAA, and Other Statutes 

and Executive Orders 

The proposed rule fails to meet even the most basic procedural and substantive 

obligations. The Administrative Procedure Act (APA) requires that the "opportunity for 

comment must be a meaningful opportunity," and "[t]hat means enough time with enough 

information to comment and for the agency to consider and respond to the comments." 

Prometheus Radio Project v. FCC, 652 F.3d 431, 450 (3d Cir. 20 II) (internal citation and 

quotation marks omitted). See also Am. Hasp. Ass 'n v. Bowen, 834 F.2d 1037, 1044-45 (D.C. 

Cir. 1987) (noting the "obvious importance of the [APA's] policy goals of maximum 

participation and full information."). For its part, the Clean Air Act (CAA) "requires a much 

more detailed notice of proposed rulemaking than does the APA." Union Oil Co. of Cal. v. EPA. 

821 F.2d 678, 682 (D.C. Cir. 1987); see Small Refiner Lead Phase-Down Task Force v. EPA, 

705 F.2d 506, 550 (D.C. Cir. 1983) ("[TJhe additional notice requirements in§ 307(d)(3) suggest 

that Congress intended agency notice under the Clean Air Act to be more, not less, extensive 

than under the APA.''). Executive Order 13563 underscores these obligations requiring that to 

promote "open exchange of information and perspectives among State, local, and tribal officials, 

experts in relevant disciplines, affected stakeholders in the private sector, and the public as a 

whole,., agencies "shall endeavor to provide the public with an opportunity to participate in the 

regulatory process.''568 

Moreover, notice has to be provided by the agency; it cannot be bootstrapped from the 

public comments.569 The reasons are evident: there is no requirement for parties to monitor all of 

the thousands or tens of thousands of submitted comments in order to guess the issues on which 

to comment. 570 A contrary rule ·'would turn notice into an elaborate treasure hunt, in which 

interested parties, assisted by high-priced guides (called 'lawyers'), must search the record for 

the buried treasure of a possibly relevant comment."571 

Drafting these comments has entailed a great deal of guesswork. The comments of EDF 

or any other commenter on a particular issue thus should not be taken to mean that EPA provided 

sufficient notice of that issue. 

The proposed rule lacks essential elements needed to understand it, rendering the 

opportunity for comment meaningless. The Proposal contains vague and contradictory 

statements about its actual substance and eftect, tails entirely to analyze and disclose its costs 

"'

7 83 Fed. Reg. 18.768.18.768-9 (Apr. 30. 2018). 

SM~ Exec. Order 13563 ~ 2. 

" 9 Small Refiner Leadl'lwse-Down Task Force t'. EPA. 705 F.2d 506, 547 (D.C. Cir. 1983): Shell Oil Co. r. EPA. 

950 F.2d 741. 760-61 (D.C. Cir. 1991); CS\' Trans. v. Smjitce Tramp. Bd 584 F.3d 1076, I 082 (D.C. Cir. 2009): 

Ci!y ~f'Waukesha v. EPA. 320 F.3d 228.234 (D.C. Cir. 2003). 570 Am. Fed'n of Labort'. Donol'an. 757 F.2d 330, 340 (D.C. Cir. 1985); Fer!ili:erlnsl.v. EPA. 935 F.2d 1303, 1312 

(D.C. Cir. 1991). 

S7! Sma!l Rejlner Lead Phase Down. 705 F.2d at j50. 

121 
201 


33371.183

and benefits, and is littered with vague references to entire websites and executive branch 

departments. The cursory reasoning and wholly inadequate record offered in support of the 

proposed rule prevents stakeholders from engaging with the agency on its rationale for the 

proposed action and its costs and benefits, or offering contrary evidence. Finally, EPA has not 

provided any basis whatsoever to warrant the gross inadequacies of the proposed rule and the 

process to consider it. With such a deeply deficient basis for action, the only legally viable 

course is to withdraw the Proposal. 

A. The Proposed Rule is a Binding, Legislative Rule and Subject to the 

Requirements of the APA 

The Administrative Procedure Act, the Clean Air Act, and other federal statutes proscribe 

procedures that must be followed in agency rulemaking, and which EPA has failed to meet in its 

Proposal. This proposed rule docs not fit into any of the exceptions the APA provides for the 

procedural requirements of rulemaking-it is neither an interpretive rule, general statement of 

policy, or a rule of agency organization, procedure or practice.572 

The proposed rule does not purport to clarify or explain an already existing statute or 

rule, and thus is not an interpretive rule:m The proposed rule is not a general statement of policy, 

because it establishes a standard of conduct, which has the force oflaw. It uses mandatory 

language indicating a requirement: ''When promulgating significant regulatory actions, the 

Agency shall ensure that dose response data and models underlying pivotal regulatory science 

are publicly available in a manner sutlicient for independent validation."574 Unlike a general 

statement of policy. which "does not establish a 'binding norm,' ... [and] is not finally 

determinative of the issues or rights to which it is addressed," EPA here makes no qualifications 

that it has any leeway to not follow the Proposal's new requirements in all future regulatory 

actions. 575 The provision allowing the EPA Administrator to grant exceptions in a limited 

number of cases does not turn this rule into a general statement of policy because it also binds 

the Administrator's discretion, allowing deviation from the policy only when they make specific 

findings. 576 EPA has not indicated that "in subsequent proceedings it will thoroughly consider 

not only the policy's applicability to the facts of a given case but also the underlying validity of 

the policy itself," but seems poised to apply the policy in all instances-granting exceptions only 

in limited circumstances where compliance is deemed impracticable. 577 It nowhere indicates that 

EPA may reassess in each case whether following this rule is the best means to achieve scientific 

integrity as it undertakes regulatory action. The Proposal has other indications of a binding rule, 

including that EPA intends to codify it in the Code of Federal Regulations. and EPA has itself 

characterized the Proposal as a binding rule. 578 

572 5 u.s.c. § 553. 571 Guardian Fed Sav. & Loan Asso v. Fed Sav. & Loan Ins. Corp .. 589 F.2d 658.665 (D.C. Cir. 1978). 

"·'Proposed Rule, 83 Fed. Reg. at 18.773 (emphasis added); Pac. Gas & Elec. Co. v. Fed Power Com .. 506 F.2d 

33.38-39 (D.C. Cir. 1974), 575 Pac. Gas & Elec. Co. v. Fed Power Com .. 506 F.2d 33. 38 (D.C. Cir. 1974). 

Proposed Rule. 83 Fed. Reg. at 18.774. 517 Pac. Gas & E/ec. Co. r. Fed P01rer Com .. 506 F.2d 33. 39 (D.C. Cir. 1974). 518 Robinson Meyer, Sco/1 Pruill's Xew Rule Could Comple!ely Tran~formlhe EPA. The Atlantic (Apr. 24, 2018). 

h Ups:/ /wW\'-". thea t! antic. com/ science/ arch i v e/2 0 18/04/how-the-epas-nc\v-secrct -sci cnce-ru! c/5 58 8 7 8/ (as 

122 
202 


33371.184

This rule is also not a rule of agency organization, procedure or practice. for purposes of 

the APA. Agency actions in this category are those "that do not themselves alter the rights or 

interests of parties, although it may alter the manner in which the parties present themselves or 

their viewpoints to the agency ."579 An agency action that "trenches on substantial private rights 

and interests" does not fall under this exemption580 By restricting the scientific studies on which 

EPA may base final significant regulatory actions, EPA severely limits parties from relying on 

excluded studies in advocating for particular safeguards. In the preamble, EPA makes clear that 

the rule is about "EPA's regulatory actions" and underlying conclusions. 5

8 ' Because the rule 

substantively impacts agency conclusions and regulations, it impacts private rights and interests. 

The rule does not allow private individuals to submit for consideration (or renders such submittal 

a nullity) studies that they would have been permitted to prior to the proposed rule, thus 

impacting the substantive standards that EPA is able to justify setting-which has implications 

for the regulated community as well as for public health. The Proposal "encodes a substantive 

value judgment or puts a stamp of approval or disapproval on a given type of behavior" by 

requiring regulatory actions to be supported only by certain scientific information deemed 

acceptable by the proposed rule. 5

8

' 

In CropLife Am. v. E.P.A., the Court held that a similar rule promulgated by EPA, barring 

third-party human studies from agency consideration during pesticide registrations was a binding 

regulation because it used "clear and unequivocal language" reflecting "an obvious change in 

established agency practice" that created a "binding nonn.''583 The Court stated: ·'EPA's stated 

rule is binding on petitioners, who arc now barred from relying on third-party human studies 

(even in cases where such studies formerly were approved), and is binding on the agency 

because EPA has made it clear that it simply 'will not consider' human studics."584 Similarly, the 

Proposal appears to bind EPA to not consider scientific information it could consider before. 

unless it falls under certain narrow, ambiguously defined exceptions, and binds the public and 

organizations such as EDF who can no longer submit studies to EPA that EPA would previously 

have been required to consider as part of the mlemaking process. 

B. The Proposal is Subject to the Procedural Requirements of the Clean Air 

Act. 

Administrator Pruitt signed the Proposal. he stated: "This is not a policy. This is not a memo. This is a proposed 

rule."). 

579 Ballerton v. Marshall. 648 F.2d 694, 707 (D.C. Cir. 1980). 580 Ballerton v. Marshall. 648 F.2d 694.708 (D.C. Cir. 1980). 581 83 Fed. Reg. 18.769. 580 Am. Hasp. Asso. v. Bowen. 834 F.2d 1037. 1047 (D.C. Cir. 1987). See also Pharm Mfrs. Asso. r. Finch. 307 F. 

Supp. 858. 865 (D. Del. 1970) (tinding that a regulation promulgating new criteria f(1f' clinical investigations that 

will meet the standards of evidence necessary to demonstrate the effectiveness of drug products, and excluding 

certain kinds of clinical investigations, was not merely a procedural rule, because they ''did effect a material 

narrov,ring of the range of evidence which previously had been considered relevant in evaluating a drug's efficacy. 

Because of the important clarification of acceptable testing standards effected by the September regulations and 

because of the substantial impact of these regulations on the drug industry .... ") 581 329 F.3d 876. 881 (D.C. Cir. 2003). 58~ !d. 

123 
203 


33371.185

Section 307(d) applies to "such ... actions as the Administrator may determine."585 EPA 

claims to take this action under "authority of the statutes it administers ... including Clean Air 

Act sections I 03, 30 I (a)."586 By issuing this Proposal through notice and comment procedures, 

Administrator Pruitt appears to have determined that 307(d) procedures apply. 

Even without that invocation, the proposed rule is subject to these procedural 

requirements because it materially impacts many of the actions delineated in 307(d)( I) to which 

the CAA rulemaking procedures explicitly apply. The Proposal applies to "significant regulatory 

actions:' which many of these actions are. The CAA requires science-based decision-making that 

the Proposal will materially affect. For example, by restricting the science EPA may rely on in 

regulatory actions, the Proposal materially impacts residual risk determinations for hazardous air 

pollutants(§ 307(d)(I)(C)), standards for mobile source air toxics (§ 307 (d)(l)(K)), and residual 

risk standards for municipal solid waste combustors(§ 307(d)(I)(D)). 587 

This proposed rule directly affects EPA's setting and review of National Ambient Air 

Quality Standards (NAAQS),588 the promulgation or revision of which is subject to the CAA 

rulemaking requirements.589 Section 108(a) of the Clean Air Act requires the Administrator to set 

air quality criteria for air pollutants that ·'reflect the latest scientific knowledge." This Proposal 

amends the science EPA can consider for air quality criteria. Under CAA section 109 EPA must 

usc the air quality criteria to set primary and secondary NAAQS and periodically review themwhich EPA is currently doing for Particulate Matter. 590 In the Proposal. EPA cites Am. Trucking 

Ass'ns v. EPA. 283 F.3d 355, 358 (D.C. Cir. 2002) as an example of an instance where EPA 

relied on a scientific study where the underlying data was not publicly available. EPA states that 

under the Proposal use of such science would be "preclude[ d]". 591 In Am. Trucking Ass'ns the 

Court upheld EPA's use of key studies underlying the NAAQS for PM. Under the Proposal, EPA 

would not have been permitted to use those studies, and it is unclear how the Proposal will affect 

EPA's reliance on these studies as it undertakes its review. This demonstrates how this Proposal 

would have an immediate impact on EPA NAAQS-setting under the CAA. EPA is thus subject 

to the CAA 307(d) procedural requirements for this Proposal. 

C. EPA Has Failed to Provide a Properly Developed Docket and Record as 

Required by the APA and CAA and Has Thereby Violated the Notice Requirements 

of these Statutes 

EPA has failed to provide a properly developed record in support of the proposed rule. 

EPA has not identified sufficient supporting evidence in the Proposal or in its docket and has 

failed to provide adequate notice of the supporting evidence for the public to respond to 

585 42 U.S.C.S. * 7607(d)(l )(V). 

"" 83 Fed. Reg. at I 8.769. 

"'83 Fed. Reg. at 18.773. 

"' CAA Secti~n lOS( a). 53" CAA Section 307(d)( I )(A). 

·"'0 See Release oft he Final integrated Review Planjbr the National Ambient Air Quality. 81 Fed. Reg. 87.933 (Dec. 

6. 2016). 59 ; 83 Fed. Reg. at !8.769 n. 3. 

124 
204 


33371.186

meaningfully, as the Administrative Procedure Act, the Clean Air Act, and other substantive 

statutes require. 

Under the APA, agencies must base their actions on examination of the facts, "the agency 

must examine the relevant data and articulate a satisfactory explanation for its action including a 

'rational connection between the facts found and the choice made.'"592 The factual determination 

underlying the agency decision must be based on substantial evidence and will be set aside "if 

the agency 'relied on factors which Congress has not intended it to consider, entirely failed to 

consider an important aspect of the problem, offered an explanation for its decision that runs 

counter to the evidence before the agency, or is so implausible that it could not be ascribed to a 

difference in view or the product of agency expertise. "'593 

Rulemaking under the Clean Air Act is subject to the same general requirements of 

statutory conformity and reasoned decision-making derived from the APA and basic principles 

of administrative law. Clean Air Act rules cannot be "arbitrary, capricious, an abuse of 

discretion, or otherwise not in accordance with law," ·'in excess of statutory jurisdiction, 

authority, or limitations, or short of statutory right," or "without observance of procedure 

required by law." 

As noted in Appendix A and below in Section Vlli.D EPA's citations for support in the 

Proposal are vague and uninformative, and even where the particular citation can be identified 

and located, it is often not clear how EPA thinks the citation suppm1s the Proposal. This docs not 

meet the standards of the APA and CAA. 

Additionally, EPA has failed to meet the docket requirements of the CAA. CAA section 

307(d)(3) requires that publication of the proposed rule in the Federal Register include a 

summary of the factual data on which the proposed rule is based, the methodology used in 

obtaining the data and in analyzing the data, and the major legal interpretations and policy 

consideration underlying the proposed rule. It also requires the agency to place "[a]ll data, 

information, and documents ... on which the proposed rule relies" in the rulemaking docket on 

the date of publication of the proposed rule. 5°• The undifferentiated citation of articles and 

policies, most of which contradict the Proposal or otherwise offer no support for it, fails abjectly 

to satisfy these requirements.595 Any document that becomes available after the proposed rule 

Molar Vehicle A{ji·s. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29.43-44, (1933). 591 Cab!evision Sys. Cmp. v. FCC. 597 F.3d 1306. 1310 (D.C. Cir. 2010). 504 CAA Section 307(d)(3). 595 See Kenneco/1 v. EPA, 684 F.2d 1007, 1018 (D.C. Cir. l982)("Scction 307(d)(3) requires that notice of proposed 

.. regulations be accompanied by a statement of their basis and purpose. including the factual data on \Vhich the 

proposed regulations are based. the methodology used in obtaining and analyzing the data. and the major legal 

interpretations and policy considerations underlying the proposed regulations._ _Though EPA states in its 

preamble to the final regulations that its current eligibility test is based upon a closure policy adopted by EPA before 

1977. and that it has used iinandal tests similar to the present closure test under the agency's existing policy.no 

documents embodying those tests or demonstrating the methodology used before 1977 were ever placed in the 

docket. The only document in the docket purporting to explain that a closure test was ever employed by cPA was a 

memorandum in which EPA economist 1-la!c sets ttwth his recollection that such a test had been used bef{)re 1977 to 

determine '-'Vhether smelters would be permitted to rely upon dispersion techniques to meet the ambient standards. 

That memo, dated August 17. 1979. was placed in the docket on March 12, 1980, approximately eleven months at\er 

125 
205 


33371.187

has been published and that is of central relevance to the rulemaking must also be placed in the 

docket as soon as possible after its availability. 596 The agency must allow enough time for 

participants in the rulemaking to respond to those documents with comments5 n 

As of the date of the publication of the Proposal, the docket at regulations.gov contained 

only the following 12 documents: (I) OIRA Review Start Document (Apr. 17, 20 18); (2) OIRA 

Review Conclusion Document (Apr. 23, 2018); (3) White House Memorandum on Scientific 

Integrity (Mar. 9, 2009); ( 4) Guidelines for Ensuring and Maximizing the Quality, Objectivity, 

Utility, and Integrity of Information Disseminated by Federal Agencies; Republication, 67 Fed. 

Reg. 8,452 (Feb. 22, 2002); (5) Exec. Order 13,777, Enforcing the Regulatory Reform Agenda, 

82 Fed. Reg. 12.285 (Feb. 24, 2017); (6) EPA, Plan to Increase Access to Results ofEPAFunded Scientific Research (Nov. 29. 2016); (7) OMB Memorandum M-05-03 on Issuance of 

OMB's ''Final information Quality Bulletin for Peer Review" (Dec. 16, 2018); (8) EPA, 

Guidelines for Ensuring and Maximizing the Quality. Objectivity, Utility, and Integrity of 

Information Disseminated by the Environmental Protection Agenq (Oct. 2002); (9) Exec. Order 

13.563, Improving Regulation and Regulatory Review, 76 Fed. Reg. 3,821 (Jan. 18, 2011); (I 0) 

Exec. Order 16, 093, Promoting Energy Independence and Economic Growth, 82 Fed. Reg. 

16,093 (Mar. 28, 2017); (11) OMB Memorandum M-13-13: Open Data Policy-Managing 

Information as an Asset (May 9, 20 13); (12) Commission on Evidence-Based Policymaking, The 

Promise of Evidence-Based Policymaking (Sep. 2017). 

This clearly is not enough to meet the APA 's or CAA's requirements. Aside trom the 

drafts of the proposed rule submitted to OIRA, each of these documents was a pre-existing 

memorandum, policy document, or executive order that contains no specific analysis-factual, 

legal, policy or otherwise-that pertains to the impacts of or at all justifies this proposed rule. 

While EPA in the proposed rule cites to some of these documents as purportedly being consistent 

with these prior policies, see, e.g., 83 Fed. Reg. at 18,769-70, as is discussed in Section II and in 

Appendix A, these policies do not in fact provide any basis for the Proposal. The record that 

EPA provides clearly fails to support its proposed action. Some of the factual data, legal 

interpretations, and policy considerations that EPA has not sufficiently provided evidence for 

include: the number of scientific studies that would be precluded from consideration under the 

Proposal; whether there are fields of research where the Proposal would result in insufficient 

scientific information available for EPA to meet its statutory duties; how EPA will address the 

substantial privacy concerns implicated by the Proposal; how application of this Proposal will 

impact substantive agency actions; what the costs of implementing this Proposal are if EPA 

intends to not just exclude studies from consideration where too costly to provide access, etc. 

EPA, for instance, includes Executive Order 13,563 in the docket to support its statement 

that "[t]he best available science must serve as the foundation of EPA's regulatory actions."598 

While Executive Order 13,563 makes that statement, it does not support EPA's Proposal, which 

the close ofthe public comment period, and reveals neither the actual tests nor the methodology used by EPA. The 

failure of EPA to observe the procedures mandated by*~ 307(d)(3) and 307(d)(6) was thus arbitrary and 

capricious."') 

5

<16 CAA Section 307(d)(4). 

" 7 Sierra Club''· Cost/e. 657 F.2d 298, 352 (D.C. Cir. 1981 l: Union Oil Co. ''· EPA. 821 F.2d 678, 683 (D.C. Cir. 

1987). 

5

" 83 Fed. Reg. at 18,769 n. 1. 

126 
206 


33371.188

as explained above, hinders EPA's use ofthe best available science. EPA provides no evidence 

or explanation in the docket or Proposal for why EPA believes this policy would further that 

goal. The executive order only states that agencies should make available to the public the 

scientific or technological .findings or conclusions on which rules rely, as opposed to underlying 

raw data that EPA has targeted with this Proposal. Meanwhile, EPA blatantly violates the 

executive order's provisions requiring agencies to weigh costs and benefits; to write regulations 

that are easy to understand; and to provide the scientific and technical findings underlying the 

rule for the public to comment on. 

Section 307(d)(3) of the CAA requires that "[a]ll data, information, and documents ... on 

which the proposed rule relies shall be included in the docket on the date of publication of the 

proposed rule." Many items that EPA cites to in the Proposal as providing a basis for the 

proposed rule do not appear in the docket. For example, EPA states: ''The proposed rule takes 

into consideration the policies or recommendations of third party organizations who advocated 

tor open scicncc."599 In a footnote, EPA provides: "These include policies and recommendations 

from: The Administrative Conference of the United States' Science in the Administrative 

Process Project; National Academies' reports on Improving Access to and Confidentiality of 

Research Data, Expanding Access to Research Data, and Access to Research Data in the 21st 

Century: the Health Effects Institute; Center tor Open Science; members of the Risk Assessment 

Specialty Section of the Society ofToxicology. the Dose Response Section of the Society for 

Risk Analysis. and the International Society for Regulatory Toxicology and Pharmacology; and 

the Bipartisan Policy Center's Science for Policy Project.''600 Many of these policies and 

recommendations did not appear in the docket on the data of publication of the Proposal and still 

do not appear in the docket-a clear violation of the CAA-nor are the specific documents or 

reports even identified or properly cited so that they may be tracked down. This is evidently 

prejudicial to commenters-it undermines commenters ability to submit meaningful feedback 

when the agency is hiding the ball in this manner. 

These policies and recommendations arc not easily identifiable on their own either, even 

after significant internet research. This is also true of footnote 16, where EPA lists a number of 

agencies to support its claim that the federal government is already implementing solutions to 

data disclosure 601 EPA cites, for example, the Nationallnstitute of Standards of Technology. 

NIST has numerous policy documents on protecting privacy concerns and keeping data secure as 

well as its own internal policies on releasing data. It is hard to see how any arc relevant here, but 

without a particular cite the public is denied even a chance to respond to whatever EPA is trying 

to use as support-or must respond to everything that might be being referenced, creating a 

burdensome task. Throughout these comments, as we attempt to respond to EPA's Proposal, we 

have been very practically limited by our inability, even after much research and consideration, 

to be fully certain we have identified the appropriate policies to respond to. This presents a 

situation that the CAA's docket requirement was exactly formulated to prevent. 

500 83 Fed. Reg. at 18.770. 

"

00 83 Fed. Reg. at 18.770 n. 10. 

WI 83 Fed. Reg. at 18.770 n. 16. 

127 
207 


33371.189

On May 25, 2018, EPA added a memorandum to the docket for this rulemaking602 This 

memorandum contains hyperlinks apparently intended to accompany various citations in the 

footnotes of the Proposal. This document does not cure the former procedural defect, as the CAA 

requires information the proposed rule relies on to be placed in the docket on the day the 

proposed rule is published.603 Further, these hyper! inks still link ambiguously to various 

documents and agency websitcs without providing any information about what specifically EPA 

intends to cite or how the cited information is being used or considered by EPA. Additionally, 

simply adding such a document to the docket does not provide adequate notice to the public. 

Someone who had access only to the proposed rule and was not carefully monitoring the docket 

would have no indication or notice of this new document. 

Either EPA is failing to comply with the CAA 's requirements by failing to include in the 

docket factual data, legal interpretations, and policy considerations that support the Proposal, or 

these supporting items do not exist, deeming this rulemaking completely arbitrary-in either 

case the Proposal fails to meet the standards of the APA and CAA. Under the CAA the 

rulemaking docket "must provide the entire basis for the final rule and the exclusive record for 

judicial review,'' this docket clearly cannot support a final rule. 604 

D. The Proposal is too Vague for Meaningful Comment. 

Section 553 of the APA, 5 U.S.C. § 553(b)(3), requires that an agency proposing a rule 

"provide sufficient factual detail and rationale for the rule to permit interested parties to 

comment meaningfully.''605 The Clean Air Act requires even more, that the Federal Register 

notice be accompanied by a statement of basis and purpose that includes a summary of the 

factual data on which the proposed rule is based, the methodology used in obtaining the data and 

in analyzing the data; and the major legal interpretations and policy considerations underlying 

the proposed rule. 606 As discussed above, all data, information, and documents on which the 

proposed rule relies must be included in the docket on the date of publication of the proposed 

rule. 607 

These core requirements are "designed (I) to ensure that agency regulations are tested via 

exposure to diverse public comment. (2) to ensure fairness to atTccted parties, and (3) to give 

affected parties an opportunity to develop evidence in the record to support their objections to 

the rule and thereby enhance the quality of judicial review.''608 In addition, "a chance to 

comment ... [enables) the agency [to) maintain[) a flexible and open-minded attitude towards its 

602 EPA Memorandum RE: Omitted Hyperlinks for Footnotes in the Proposed Rule (May 25. 2018). EPA-HQ-OA20 18-0259-0812. 603 Section 307(d)(3). 604 Union Oil Co. of California v. EPA .. 821 F.2d 678. 681-82 (D.C. Cir. 1987). 

"

05 United States Telecom Assn. v. FCC, 825 FJd 674.700 (D.C. Cir. 2016) (quoting /loneywe/1 Inti.. Inc.\'. EPA. 

372 F.3d 441.445 (D.C. Cir. 2004) (internal quotation marks omitted). 606 42 u.s.c. § 7607(d)(3). 

""' 42 u.s.c. * 7607(d)(3). 608 lnt '/ Union. United Mine Workers ojAm. v. Mine Safety and Health Admin .. 407 F.Jd 1250. 1259 (D.C. Cir. 

2005). 

128 
208 


33371.190

own rules,"609 and ·'avoid[s] the inherently arbitrary nature of unpublished ad hoc 

determinations."610 The "notice required by the APA ... must disclose in detail the thinking that 

has animated the form of a proposed ru lc and the data upon which that rule is based . . . . [A ]n 

agency proposing informal rulemaking has an obligation to make its views known to the public 

in a concrete and focused form so as to make criticism or formulation of alternatives possible." 

Home Box Qffice, Inc. v. FCC. 567 F.2d 9, 35-36 (D.C. Cir. 1977); see also Horsehead Res. Dev. 

Co., Inc. v. Browner. 16 F.3d 1246, 1268 (D.C. Cir. 1994) ("[A]n agency must describe the range 

of alternatives being considered with reasonable specificity. Otherwise. interested parties will not 

know what to comment on, and notice will not lead to better-informed agency decisionmaking.") (internal citations and quotation marks omitted). 

The failure to include critical documents relevant to the proposed rule in the docket, as 

required by the Clean Air Act, itself constitutes a notice violation because "'absence of those 

documents, or of comparable materials ... makes impossible any meaningful comment on the 

merits of EPA's assertions."611 By failing to provide a more developed docket, EPA is frustrating 

the terms and purposes of these statute's notice requirements. These procedures are in place to 

form a "specific" proposal that can serve as a ''focus for comments," Small Refiner Lead PhaseDown Task Force v. EPA, 705 F.2d 506, 548-49 (D.C. Cir. 1983); see Home Box Office, Inc. v. 

FCC, 567 F.2d 9, 36 (D.C. Cir. 1977) (agency must "make its views known ... in a concrete and 

focused form so as to make criticism or formulation of alternatives possible''). Because EPA has 

not provided supporting evidence, has not included key items it points to as major considerations 

underlying the Proposal, and has generally presented a vague and unspecified proposed rule and 

docket, EDF and the public are hindered in our ability to provide specific comment focused on 

the underpinnings of the Proposal, because we do not know and can only guess as to what they 

are.612 

Even the text of EPA's proposed rule and the statement of basis and purpose fails to 

provide the requisite notice to allow meaningful comment. At the most fundamental level, it 

contains vague and contradictory statements about the actual effect of the Proposal. The Proposal 

generally appears to make its requirements mandatory-i.e., failure to make information publicly 

available will preclude the agency from relying on the study at all. See 83 Fed. Reg. at 18,769 n. 

3 ("EPA is proposing to exercise its discretionary authority to establish a policy that would 

preclude it from using such data in future regulatory actions."); id. at 18,771 ("the regulatory text 

would impose requirements''); see also id. at 18,769 ("EPA will ensure that the data and models 

underlying the science is publicly available .. .'') (emphasis added) and proposed section 30.5 

(''When promulgating significant regulatory actions, the Agency shall ensure that does response 

data and models underlying pivotal regulatory science are publicly available in a manner 

sufficient for independent validation"). In a few places, however, the Proposal makes it sound as 

if its aims are more aspirational. See id. at 18,770 ("Where available and appropriate, EPA will 

use peer-reviewed information, standardized test methods, consistent data evaluation procedures, 

609 McLouth Steel Prods. Cmp. v. Thomas, 838 F.2d 1317, !325 (D.C. Cir. 1988) (internal citation and quotation 

marks omitted). 610 L'nited States\'. Revnolds. 710 F.3d 498. 519-20 (3d Cir. 20 13). 611 Kennecott Corp. v .. EPA. 684 F.2d 1007, !0!8 (D.C. Cir. !982). 612 ''Without a readily accessible statement of the agency's rationale, interested parties [could not] comment 

meaningfully during the rulemaking process." Ne. Md. Waste Disposal Auth. v. EPA. 358 F.3d 936.949 (D.C. Cir. 

2004). 

129 
209 


33371.191

and good laboratory practices to ensure transparent, understandable, and reproducible scientific 

assessments.") (emphasis added); id. at 18,772 ("The proposed rule directs EPA to make a// 

reasonable efforts to" make data publicly available, but "does not compel the Agency to make 

that information available where it concludes after all such reasonable efforts that doing so in 

way [sic] that complies with the law and appropriate protections is not possible.") (emphasis 

added); see also id. at 18,768 ("EPA should ensure that the data underlying those are publicly 

available .. .'') (emphasis added). The difference between a requirement precluding use of science 

and making all best efforts to make data publicly available is enormous. 

To the extent EPA intends to propose a rule that would preclude use of science, as it 

appears the Proposal would do, the proposed rule is further flawed because it contains no 

analysis of how that would affect regulations. How many studies docs EPA typically rely on in 

promulgating regulations? What percentage ofthese would meet EPA's new requirements? For 

those that do not. how many could not meet these requirements for patient privacy, confidential 

business information, or other reasons? How would EPA set standards if it must rely on many 

fewer studies? Would EPA be precautionary in the face ofless evidence? Would EPA delay 

promulgating regulations in order to comply with this new mandate? How does this mandate 

interact with statutory deadlines or statutory requirements that EPA look at a wide range of 

science? None of these very basic questions are addressed in the proposed rule and without 

answering them, it is impossible for the public to assess the import and likely consequences of 

the Proposal. Even more basically, the agency gives no notice as to the Proposal's impacts, its 

costs, its benefits, why it applies only to regulatory requirements but not to any regulatory 

actions (like licensing or permitting) that confer a benefit, substantive and procedural criteria for 

adjudicating waivers, or even the legal theory under which the Proposal issues-the plaintive 

solicitation for comment as to "additional or alternative sources" of authority, 83 Fed. Reg. at 

18771, does not suffice. 

To the extent the Proposal is intended to solicit comment on how EPA may make 

reasonable efforts to make data publicly available it is also unlawfully vague. The proposed rule 

includes numerous footnotes referencing entire websites or even Departments of the Executive 

Branch. For example, the Proposal claims that "EPA believes that concerns about access to 

confidential or private information can, in many cases, be addressed through the application of 

solutions commonly used across some parts of the Federal government."613 To support this 

proposition, EPA remarkably cites (without any further elaboration or explanation in the 

proposal itself) to •·examples from the U.S. Department of Health and Human Services, National 

Institute of Standards and Technology, U.S. Department of Education, and the U.S. Census 

Bureau.''614 See Small Lead R~finer Phase Down, 705 F. 2d at 548 (requirement that comments 

arc to raise issues with "reasonable specificity" applies equally to the agency giving notice). For 

example, it is not possible to identify whether the sources referenced support EPA's claim that 

there are approaches available to address the serious privacy issues raised by the Proposalwithout providing the specific policies and recommendations, a public commenter has no way of 

knowing whether they are consistent or why EPA believes them to be consistent. It is impossible 

to respond in a meaningful way without significant guesswork. 

'' 13 Proposed Rule, 83 Fed. Reg. at 18,770. 

''14 fd at 18.770 n. 16. 

130 
210 


33371.192

Similarly, in footnote 10, where EPA lists a number of organizations whose "policies and 

recommendations" the Proposal allegedly took under consideration-no explanation is 

provided.615 In addition, in the proposed rule EPA fails to adequately define key terms like 

"validation", "independence'', ''reproducibility," "replication," and "uncertainty," while also 

citing a "replication crisis" in science. It is important that these terms are defined clearly as these 

terms are not defined consistently across the scientific community nor governments-which has 

implications for the scope and purview of the proposed rule. 

This amount of information is wholly insufficient to allow a public commenter to provide 

meaningtl.!l comments about these issues. 

Courts have been reluctant to find that important information appearing solely in the 

footnote of a rulemaking document satisfied the notice requirement of the APA, holding that "an 

agency may not turn the provision of notice into a bureaucratic game of hide and seek."616 

Referencing a key document without fllliher discussion in the rulemaking document itself, and 

without incorporating it by reference or publishing it in the Federal Register, also does not satisfy 

the notice requirements of the APA617 Subsequent publication of the document may not be 

enough to cure a defect of notice where an important issue is ''belied by the obscurity of the 

footnote intended to give notice" and further agency procedure is required to provide the public 

with "the opportunity to comment on a significant part of the agency's decisionmaking process as 

required by section 553.''618 Thus. the undifferentiated citations in the footnotes of the Proposal 

do not give adequate notice for public comment. 619 

E. EPA Must Comply With Other Requirements of the Clean Air Act 

As discussed above, the Proposal impacts EPA ·s process lor setting N AAAQs in material 

ways by amending the scientific information that can be used as air quality criteria. Under the 

CAA air quality criteria cannot be amended without review by the Clean Air Science Advisory 

Committee (CASAC).620 Thus. EPA must submit this proposal to CASAC for review. consider 

~>IS S3 red. Reg. at 1 S.770. n. 10 ("These include policies and recommendations from: The Administrative 

Conference of the United States· Science in the Administrative process Project: National Academics· reports on 

lmproring Access to and Conjldentiality of Research Data, Expanding Access to Research Data, and Access to 

Research Data in the 21st Cen/W}': the Health Effects Institute; Center tOr Open Science: members of the Risk 

Assessment Specialty Section of the Society of Toxicology, the Dose Response Section of the Society for Risk 

Analysis. and the International Society for Regulatory Toxicology and Pharmacology; and the Bipartisan Policy 

Center's Science for Policy Project.) 

" 6 MC! Telcommunications Corp.''· FCC. 57 F.3d 1136, 1142 (D.C. Cir. 1995). 617 PPG Indus, Inc. v. Cost/e. 659 F.2d 1239. 1249-50 (D.C. Cir. 1981). 

"" PPG Indus., Inc. r. Castle. 659 F.2d 1239, 1250 (D.C. Cir. 1981 ). 619 See. e.g. Chamber of Commerce l'. SEC, 443 F. 3d 890, 899 (D.C. Cir. 2006); Jackson v. Des Moines Mun. 

!lousing Agency. No. 4:07-cv-00438-HDV. 2008 U.S. Dist. LEXIS 125003, at *8-9 (S.D. Iowa June 4, 2008); 

Bil/ingtonv. Undenrood. 613 F.2d 91. 94 (5th Cir. 1980) (''Such a statement must be sufficiently specific tor it to 

enable an applicant to prepare rebuttal evidence to introduce at his hearing appearance."); Edgecomb v. Housing 

Auth .. X24 F.Supp. at 312. 314-15 ( 1993): Driver v. Housing Auth., 713 N.W.2d 670.673 (Wis. Ct. App. 2006); 

Owner-Operator fndepende/11 Drivers Ass'n. Inc. v. Federal Aiotor Carrier Safety Admin .• 494 !'.3d 188. 209 (D.C. 

Cir. 2007) ("It is certainly true that a notice can be "too general to be adequate."). 

''

00 CAA * 109(d)(2)(fl). 

131 
211 


33371.193

their recommendations. and provide reasonable explanation tor deviation trom those 

rccommendations.''21 

F. EPA Failed to Submit the Proposal to the SAB or to Consult with the 

Scientific and Technical Community 

There is no indication that EPA consulted with the scientific and technical communityor even its own Science Advisory Board-before proposing to require that the underlying data 

and models be made publicly available for all pivotal regulatory science regardless of ethical, 

feasibility, or confidentiality constraints. As detailed in a June 28, 2018 letter from the chair of 

the SAB, the SAB learned of the rule only through a press event, federal register notice, and 

news articles 622 The letter further explained that the proposed rule "was not identified as a major 

action in either of the Spring 2017 or Fall2017 semi-annual Regulatory Agendas,'' and that SAB 

members "had no information regarding the time line for finalizing the rule .... " 623 The letter 

also points out that "the precise design of the proposed rule appears to have been developed 

without a public process for soliciting input specifically from the scientific community." even 

though the proposed rule raises important scientific questions. 624 

Not surprisingly, the SAB concluded in its May 31,2018 meeting that the Proposal 

merits SAB review because it "deals with issues of scientific practice and proposes constraints to 

the use of scientific studies in particular contexts.''625 Moreover, the SAB chair's June 28 letter 

raises a number of questions that echo the concerns we have detailed in our comments, including 

the feasibility of providing access to data and methods for already-completed studies; "legitimate 

confidentiality and privacy interests" that would counsel against providing "complete public 

access"; the costs and effort associated with implementing the Proposal; the relationship between 

the Proposal and previous EPA efforts to encourage transparency; and the need to consider ''the 

multiple existing methods to assess the validity of prior epidemiologic studies" that '·do not 

provide public access to data and analytic methods."626 

EPA's failure to consult with the SAB is contrary to statute and to EPA's wellestablished practice. EPA must submit its Proposal to the SAB pursuant to the requirements of 

42 U.S.C. § 4365(c)(l) (the Environmental Research Development Demonstration Authorization 

Act or "ERDAA"), which requires the Administrator to submit to the SAB any proposed criteria 

document standard, limitation, or regulation, together with relevant scientific and technical 

information in the possession of the (EPA) on which the proposed action is based at the time it 

provides that proposal to another agency of the government for formal review. The SAB must 

"'' C!IA ~ 109(dl(2)(B): 307(d)(3). 020 Letter from Dr. Michael Honeycutt, Chair. Science Advisory Board. to Scott Pruitt. EPA Administrator (June 28. 

2018), 

https://yosemitc.epa.gov/sab/sabproduct.nsi/LookupWcbReport.,LastMonthBOARD/4ECB44CA28936083852582B 

B004AD E54/$file/EP A-SAB-18-003+U nsigned.pdL 

'"" !d 1>2-1. Jd 

id 

ld 

132 
212 


33371.194

then review and comment on the proposal.627 While the Administrator need not receive the 

SAB's final approval, the Administrator must consider the SAB's advice and comments.!>" 

As the SAB chair's letter notes, EPA's "usual process" is to inform the SAB about the 

publication of the agency's semi-annual regulatory agenda and provide descriptions of actions 

that are contained in the agenda, including "available information regarding the science that is 

informing these agency actions."629 That procedure was not followed here. In its evident zeal in 

the name of purported "transparency," EPA has ignored major statutory and regulatory 

requirements that provide actual transparency to the Clean Air Act's scientific review process. 630 

Should EPA decide to move forward with this Proposal, it must first allow the SAB to complete 

its review and take into account the SAB' s recommendations in any final rule. 

G. EPA's Proposal Fails to Meet the Procedural Requirements of I<'IFRA 

The Proposal lists FIFRA section 25 as an authority for the rulemaking.631 The agency, 

however, has already failed to follow several required procedures for issuing a valid regulation 

under this section of FIFRA. FIFRA section 25 requires the agency to seek comments from the 

Secretary of Agriculture on all draft proposed regulations 60 days prior to signing a proposed 

regulation for publication,"32 and 30 days prior to publication for a final rule. If the Secretary of 

Agriculture provides comments, the Administrator must also respond in writing as part of the 

proposed rulemaking package.633 FlFRA additionally requires EPA to publish a notice in the 

Federal Register simultaneously with the transmission of the proposed rule to USDA 634 And the 

statute requires the agency to submit a copy ofthe proposed rule for comment to the Scientific 

Advisory Panel ("SAP").6J5 as well as a copy to the Agriculture Committees in the House and 

Senate any time the agency is required to consult with the Secretary of Agriculture.636 This 

means that EPA here should have provided both committees and the SAP with a copy of the 

proposed regulation at least 60 days prior to publication of the Proposal in the Federal Register. 

627 42 li.S.C. §4365(c)(2). 

See H. Rep. No. 95-722 (95th Cong. lst Sees. (1977) (Conference Report). 629 Letter 1h)m Dr. Michael Honeycutt. Chair, Science Advisory Board. to Scott Pruitt. EPA Administrator (June 28. 

2018). 

630 See Memorandum ''Identifying EPA Planned Actions fOr Science Advisory Board Consideration ofthe 

Underlying Science'' fl·om Michael Goo, Assistant Administrator for Policy. Glenn Paulsen, EPA Science Advisor. 

and Vanessa Vu. Science Advisory Board Otlice Director (Dec. 27. 2012;) Memorandum from James Mihelcic. 

Chair. SAB Work Group on EPA Planned Actions for SAB Consideration of the Underlying Science to Members of 

the Chartered SAB and SAB Liaisons (Nov. 12. 2013) (explaining SAB Work Group process. where EPA sent to the 

SAB "short descriptions of major planned actions that were not yet proposed" and the SAB Work Group determined 

which of the actions merited their consideration in a public forum), 

"'' 83 Fed. Reg. 18769. 6

" 7 U.S.C. 136w(a)(2)(A). 633 7 U.S.C. 136w(a)(2l(B). 614 7 U.S.C. 136w(a)(2)(D). 635 7 U.S.C. 136w(d)(l). 

''36 7 U.S.C. 136w(a)(3). 

133 
213 


33371.195

The agency did not comply with any of these requirements, and does not indicate that it will in 

any final rule. The Proposal is therefore unlawful. 637 

To be sure, in some instances the Administrator and Secretary may together agree to 

waive some of the consultation requirements among themselves,638 but there is no indication that 

Administrator Pruitt did that with this Proposal. And even if the Administrator and Secretary 

later agree to waive the consultation requirement section 25(a)(2)(A) and (B), that waiver would 

not alter EPA's obligation to provide the SAP and the House and Senate Committees with a copy 

of the regulation. Nor would it change the fact that the Administrator illegally issued the 

Proposal without consulting the Secretary of Agriculture. A very serious consequence of these 

procedural mistakes is to deprive the agency of a full understanding of how the proposed 

rulemaking might affect the regulation of pesticides and thereby affect agriculture, human health, 

and the environment. 639 Therefore, the only lawful path forward here is for the Agency to 

withdraw the Proposal, consult with the entities required by FIFRA, and then subsequently renotice the Proposal. 

H. EPA's Proposal Fails to Meet the Procedural Requirements of the Safe 

Drinking Water Act, 42 U.S.C. § 300f Et Seq. 

EPA cites the Safe Drinking Water Act as an authority for the Proposal, but has failed to 

comply with the procedural requirements of the statute. The SDWA provides authority to 

promulgate regulations at 42 U.S.C. 300g-l(d). Though EPA does not cite this particular section, 

it is the only provision of the SDW A that provides EPA with rulemaking authority. The SDWA 

requires the Administrator to consult with the Secretary of Health and Human Services and the 

National Drinking Water Advisory Council in proposing and promulgating regulations under this 

section. EPA has not met these requirements here, and as such cannot claim to be using SDWA 

authority to promulgate this rule. 

I. EPA Unlawfully Failed to Consult with Other Agencies as Required by 

TSCA. 

When promulgating the Proposal, EPA unlawfully failed to consult with other entities as 

required by TSCA. For example, consider the sole statutory authority EPA cites under TSCA-§ 

10. 

To the extent EPA acts under TSCA § I 0, TSCA § 10 repeatedly directs EPA to consult, 

cooperate, and/or coordinate with the Secretary of Health and Human Services, and sometimes 

other agencies as well.640 EPA has not identified any specific provision ofTSCA § 10 that 

authorizes the proposed rule, and as noted above, no provision does. But if EPA acts under 

TSCA § I 0, then EPA needs to comply with the requirements of whichever provision EPA 

637 If finalized, the proposal will also have to be transmitted to the Secretary of the Senate and Clerk of the House of 

Representatives. See 7 U.S.C. 136w(a)(4). The rule does not become effective until60 days alter this rule or 

regulation i~ transmitted. 

''" 7 U.S.C. 136w(a)(2)(C). 

r,w See af:.m, Sedion ILD.8. 

"'0 15 U.S.C. § 2609(a). (b)t2)(A). (b)(2)(B). (c). (d). (e). (g). 

134 
214 


33371.196

considers relevant. Most ofthe provisions ofTSCA § 10 expressly require that EPA consult, 

coordinate, or cooperate with, at least, the Secretary of Health and Human Services (section 

IO(a), IO(b)(2)(A), IO(b)(2)(8), IO(c), IO(d), IO(e), IO(g)). For example, the provision that 

mentions "research and development results" states that EPA shall act ·'in consultation with the 

Secretary of Health and Human Services and other heads of appropriate departments and 

agencies."641 EPA does not appear to have complied with any of the procedural requirements of 

TSCA § 10. 

J. EPA Has Failed to Consult with the Science Advisory Committee on 

Chemicals 

As discussed above, this proposed rule has severe implications for the implementation of 

TSCA. The Science Advisory Committee on Chemicals' purpose is "to provide independent 

advice and expert consultation, at the request of the Administrator, with respect to the scientific 

and technical aspects of issues relating to the implementation of this subchapter."642 This 

rulemaking specifically involves "the scientific and technical aspects of issues relating to the 

implementation of[this Act]," yet there is no indication that the Administrator has consulted 

with the committee.643 Congress specifically created this Committee to consult on these types of 

issues, and thus EPA is abusing its discretion to not consult with this Committee about a 

proposal that will so radically affect the scientific and technical aspects of issues relating to the 

implementation ofTSCA. 

K. EPA Has Failed to Provide Documents in Response to EDF's FOIA Requests 

EDF currently has two Freedom of Information Act Requests directly related to the 

substance of this rulemaking pending at EPA, for which we have received no responsive 

documents thus far, despite the passage of the statutory deadlines for a response. The first 

request (No. EPA-HQ-20 18-005636) was submitted on March 20, with a determination from 

EPA statutorily due by April 19-which has not been provided. EDF submitted a second request 

(No. EPA-HQ-2018-007397) on May 4. Given the lack of transparency and information around 

the basis for this rule, its impacts, and its true motivations, EDF and the public cannot provide 

informed comment on this rule without the public records that have been requested. For EPA to 

close the public comment period on this Proposal before all relevant records are released to the 

public is arbitrary and prevents our ability to meaningfully comment. 

L. The OIRA Review Process for the Proposal Was Too Rushed to be 

Meaningful and EPA Has Not Sufficiently Coordinated with Other Federal 

Agencies 

EPA did not provide enough time for the Office oflnformation and Regulatory Affairs 

(''OIRA") to meaningfully review the Proposal. Executive Order !2,866 requires agencies to 

641 15 U.S.C. 9 2609(g). 

''" 15 U.S.C. * 2625(o)(2). 

"" 3 15 u.s.c. 9 2625(0)(2). 

!35 
215 


33371.197

submit all significant regulatory actions to OIRA.644 This submission must contain ·•an 

assessment of the potential costs and benefits of the regulatory action" in addition to other 

analyses.645 Executive Order 12,866 provides OIRA 90 days to review and return the draft 

regulatory action to the agency. 646 As indicated above, the Proposal gives scant consideration to 

the costs of the proposed action. The April 17. 2018 draft sent to OIRA for review contained no 

mention of cost and benefits of the Proposal at all.647 It appears that OMB drafted the two 

paragraphs on costs that appear in the Proposal as published in the federal registcr. 648 

EPA transmitted the Proposal to OIRA on April 19, and OIRA's website indicates that its 

review concluded on April23.649 This is not nearly sufficient time for White House review of 

this far-reaching Proposal that raises important inter-agency issues. Further, media outlets report 

that there were discrepancies in the date when OIRA concluded its review of the proposed rule, 

suggesting that the date was backdated from April 25 to April 23 only after Administrator Pruitt 

signed the proposed rule on April24.650 The public record also shows OIRA convened no 

Executive Order 12,866 meetings in regards to this rule. EDF requested such a meeting on the 

morning of April 24; our request was not granted, even though the Proposal was still listed as 

under OJRA review. 

The rushed process is particularly concerning given the proposed rule's complex crossagency impacts. A letter from a group of Democratic senators to OIRA raising these concerns 

highlighted that, on average, OIRA review of EPA rules takes 55 days. 651 Given how bare-bones 

EPA's proposed rule was, lacking many of the elements required by Executive Order 12,866, it 

seems that OIRA should have required even more time to review the Proposal. Because this rule 

affects EPA's regulatory actions across program areas and statutes and interacts with the work of 

other agencies, as discussed more in Section ll.D.8, adequate OIRA review was required to 

ensure consistency across the federal government. Certain other agencies base their standards on 

standards set by EPA. For example, FDA and EPA work together to promulgate advice on fish 

consumption, based on the reference dose calculated by EPA. The Proposal could thus have an 

impact on FDA's ability to promulgate advice on fish consumption sufficient to protect human 

health.652 Thus, EPA's disregard of scientific evidence as it sets these standards will directly 

impact the sufficiency of standards set by these agencies. 

"'4 Exec. Order 12.866. Regulatorv Planning and Revim. 58 Fed. Reg. 51.735 (Sept. 30. 1993 ). 

6..\5/d. 

04('/d 

""EO 12866 Proposal 2080-AA 14 OlRA Review Start Document (Apr. 17. 2018), ID EPA-HQ-OA-2018-0259-

0007. 

,,_,,Compare EO 12866 Proposal2080-AA14 OIRA Review Start Document (Apr. 17. 2018).10 lOPA-HQ-OA2018-0259-0007with EO 12866 Proposal2080-AA14 01RA Conclusion Document (Apr. 23. 2018), lD EPA-HQOA-2018-0259-0006. 

01 RA, 01/?A Conclusion of EO /2866 Regulatory Review for Strengthening li·ansparency and Validity in 

liegulatDJy Science. https://www.reginfo.gov/public/do/eoDetails?rrid~ 128014 (last accessed Aug. 16. 20 18). 

''50 See Sean Reilly, OMB backdates completion date for 'secret science' review. E&E News (Apr. 27. 2018). 

https://wwvv'.eenevv'S.net/grecnwire/20 18/04/27/stories/1 060080331. 1'

51 Letter fi·01n Senators Hassan. Carper. McCaskill. Markey. Harris. and Whitehouse to Ncomi Rao. Administrator. 

OlRA (Ma; 9. 20 18). hJ.tps:l/www.hassan.senatc.gov/imo/media/doc/RaoEPAL.cttcrFinal.pdf. 65::: FDA. Technical Information on Derelopment (!lFish Consumption Adyice- FD.4i£PA Advice on Vr'hat Pregnant 

/Fomen and Parents Should Know ahout Eating Fish, 

136 
216 


33371.198

As noted above, EPA failed to consult with other federal agencies before proposing this 

rule. EPA also violated its own data access plan, which says EPA "will consider how. when, and 

whether to apply the EPA policy to research that is subject to public access policies from other 

agencies" as it recognizes that "duplicative or conflicting requirements might result when 

research is subject to public access policies from multiple federal agencies".653 There is no 

evidence that EPA considered these issues or that EPA followed its own policy to "coordinate 

with other agencies and the private sector" as it implements new data access policies.654 

The usual procedures appear to have been set aside for this proposed rule, and EPA has 

provided no explanation for why shortened review procedures were necessary. It was initially 

reported that this Proposal was categorized as a "tier 3" measure, subject to the lowest amount of 

scrutiny in EPA's own internal review process, and developed largely by political appointees 

with no input from career staff, despite having characteristics of a "tier 1" measure, subject to the 

highest level of scrutiny.655 These characteristics include being precedent-setting; controversial; 

having cross-Agency, cross-media, and inter-agency impacts and controversies; and raising 

external interest, all of which are present here. Though the agency appears to have now raised it 

to ''tier I" status, the Proposal that is now available for public comment was subject only to these 

initial hasty procedures, calling into question its va!idity.656 

EPA must withdraw the Proposal and release it only under the full, proper procedures. 

https:ll"ww.faa.gov/Food/FoodbornelllnessContaminants/Metals/ucm531136.htm (last accessed Aug. I. 20 18). 

"5' EPA. Plan/a Increase Access to Results ~f EPA-I·'unded Scientific Research at 8 (Nov. 29, 2016), 

https:/ /v-.'\VW .epa.gov I sites/prod uction/ti I es/2 0 16-12/ documents/epasci cnt i fi crcsearchtranspcrancyplan .pdf. 654 ld at 15. 655 Inside EPA. EPA Science Plan Skirted Usual Process, Raising Finali=ation. Legal Doubts (May 14. 2018). 

https://insidccpa.com/dailv-news/cpa-sciencc-plan-skirted-usual-process-raising-tinalization-lcgal-doubts. 

" 56 Inside EPA. EPA Strengthens /merna/ Review q[Science Rule As SAB Seeks Scrutiny (June I, 2018), 

h ttps:/ /i nsideepa.com/ dai lv -news/ epa-stren gthens-i nternal-revi ew-sc icncc-rulc-sab-sceks-scruti nv. 

137 
217 


33371.199

Appendix A. Analysis of Sources Cited to in the Proposal 

This appendix provides an analysis oft he sources EPA cites in the proposed rule. 

showing ultimately that EPA has provided no sources or authorities that support or provide a 

reasoned basis for the proposed rule and that many of the sources raise key implementation 

concerns that EPA fail.~ at all to address-rendering the proposal arbitrary and capricious. 

Footnote 1: Sec Exec. Order No. 13563,76 Fed. Reg. 3821 (Jan. 21, 2011). "Our regulatory 

system must protect public health, welfare, safety, and our environment while promoting 

economic growth, innovation, competitiveness, and job creation. It must be based on the 

best available science." 

Exec. Order No. 13563 requires agencies to utilize the "best available science" in 

regulatory actions.657 This requirement is further encoded in numerous statutes and policies that 

EPA implements. EPA states in the proposed rule that: "The best available science must serve as 

the foundation of EPA's regulatory actions."658 However, as the comments raise more 

thoroughly, by arbitrarily restricting the scientific studies EPA will consider, this proposed rule 

will hinder EPA ·s use of the best available science and therefore violates the eommand of Exec. 

Order No. 13563 and other versions of these requirements. 

Furthermore, this executive order requires agencies to "ensure the objectivity of any 

scientific and technological information and processes used to support the agency's regulatory 

actions" consistent with the President's Memorandum for the Heads of Executive Departments 

and Agencies, "Scientific Integrity" (March 9, 2009). As the comments note. however, the 

proposed rule along with the provision allowing the Administrator to grant discretionary 

exemptions will harm the objectivity of scientific and technological information and processes at 

EPA by paving the way for politics, rather than objective scientific criteria, to dictate which 

scientific studies are considered. 

Footnote 2: See Memorandum for the Heads of Executive Department[ sic] and Agencies on 

Scientific Integrity (Mar. 9, 2009). "If scientific and technological information is developed 

and used by the Federal Government, it should ordinarily be made available to the public. 

To the extent permitted by law, there should be transparency in the preparation, 

identification, and use of scientific and technological information in policymaking." 

EPA claims about the proposal that "[b]y better informing the public. the Agency in[ sic] 

enhancing the public's ability to understand and meaningfully participate in the regulatory 

process." EPA then cites to the Memorandum for the Heads of Executive Departments and 

Agencies on Scientific Integrity. 659 Not only does the proposal con1lict with this memorandum, 

but it will make it more difficult for the public to meaningfully participate in the regulatory 

process. 

Exec. Order No. 13563.76 Fed. Reg. 3821 (Jan. 21.2011 ). 

''" 83 Fed. Reg. at 18,769. 

''50 83 Fed. Reg. at 18.769 n. 2. 

138 
218 


33371.200

The memorandum sets out a number of actions for agencies to take to ensure scientific 

integrity.660 Just one of these factors involves making scientific and technological information 

publicly available, notably specifying, "l:xceptfor information that is properTy restrictedfrom 

disclosure under procedures established in accordance with statute, regulation, Executive Order, 

or Presidential Memorandum, each agency should make available to the public the scientific or 

technological findings or conc1usions considered or relied on in policy decisions."661 The 

memorandum thus supports only making scientific findings and conclusions publicly available, 

not the data underlying those findings and conclusions. Further, it correctly notes that some 

information is properly restricted from disclosure. It does not say that the inability to disclose 

such information should prevent it from being considered by agencies. The memorandum thus 

provides no support for the notion that agencies should be barred from relying on studies where 

the underlying data cannot be disclosed. The memorandum's narrow approach to public 

disclosure should not be taken to support EPA's proposal but rather counsels against the 

proposal's mandate that all underlying data be made publicly available. 

EPA's proposal fundamentally conflicts with the heart ofthe memorandum-that "[t]he 

public must be able to trust the science and scientific process informing public policy 

decisions.''662 To earn this trust. the memorandum declares: "'Political officials should not 

suppress or alter scientific or te~hnological findings and conclusions. "663 By discarding scientific 

studies where underlying data cannot be made publicly available, this proposal will result in 

scientific findings being suppressed. By allowing the Administrator to grant exemptions to this 

policy based on their discretion with no public record or explanation, the proposal allows for the 

Administrator to pick and choose based on their preference the science informing the agency's 

actions, eroding the public's trust in the science informing public policy decisions. 

The memorandum provides a number of ways in which agencies can ensure scientific 

integrity which the proposal does not consider including: hiring candidates for science and 

technology position based on their "knowledge, credentials, experience, and integrity," having in 

place appropriate rules and procedures to ensure integrity of the scientific process, establishing 

scientific processes such as peer review and accurately reflecting scientific and technological 

information, establishing procedures to identify when scientific integrity may be compromised, 

including establishing whistleblowcr protections 664 EPA does not explain why any of these 

pathways would not serve as a better means of ensuring scientific integrity. 

Footnote 3: EPA has the authority to establish policies governing its reliance on science in 

the administration of its regulatory functions. Historically, EPA has not consistently 

observed the policies underlying this proposal, and courts have at times upheld EPA's use 

660 Memorandum for the Heads ofExecuti\'e Departments and Agencies on Scientific Integrity (Mar. 9, 2009). 74 

Fed. Reg. 10671 (Mar. I I. 2009). 661 Memorandum t(w the Heads of Executive Departments and Agencies on Scientific Integrity (Mar. 9, 2009). 74 

Fed. Reg. 10671 (Mar. 11. 2009) (emphasis added). 

""'Memorandum for the Heads of Executive Departments and Agencies on Scientific Integrity (Mar. 9. 2009). 74 

Fed. Reg. 10671 (Mar. 11. 2009). 

""Memorandum tor the Heads of Executive Departments and Agencies on Scientific Integrity (Mar. 9. 2009). 74 

fed. Reg. 10671 (Mar. II. 2009). 

""'Memorandum for the Heads of Executive Departments and Agencies on Scientific Integrity (Mar. 9. 2009). 74 

Fed. Reg. 1067! (Mar. 11. 2009). 

139 
219 


33371.201

non-public data in support of its regulatory actions. See Coalition of Battery Recyclers 

Ass'n v. EPA, 604 F.3d 613,623 (D.C. Cir. 2010); American Trucking Ass'ns v. EPA, 283 

F.3d 355, 372 (D.C. Cir. 2002). EPA is proposing to exercise its discretionary authority to 

establish a policy that would preclude it from using such data in future regulatory actions. 

In footnote 3 of the proposal, EPA notes that "courts have at times upheld EPA's use 

[sic] non-public data in support of its regulatory actions" and cites to Coalition of Battery 

Recyclers Ass 'n v. EPA, 604 F.3d 613, 623 (D.C. Cir. 2010) and American Trucking Ass 'ns v. 

EPA, 283 F.3d 355, 372 (D.C. Cir. 2002). 665 These cases indeed held that EPA's prior, longstanding position of relying on scientific studies even when the underlying data could not be 

made publicly available was reasonable. It is well-established that agencies must acknowledge 

changes in position and "show that there are good reasons for the new policy."666 This footnote, 

the only mention of EPA's previous policy, does not sufficiently acknowledge or explain why 

EPA is now changing its position. 

In American Trucking Ass 'ns v. EPA the Court held that the Clean Air Act did not require 

EPA to make public underlying data where EPA relied on the study itself and not the raw data 

underlying the study.667 The Court stated that such a requirement "would be impractical and 

unnecessary.''668 They agreed with EPA's then statement that: 

If EPA and other governmental agencies could not rely on published studies without 

conducting an independent analysis of the enormous volume of raw data underlying 

them, then much plainly relevant scientific information would become unavailable to 

EPA for use in setting standards to protect public health and the environment .... Such 

data are often the property of scientific investigators and are often not readily available 

because of ... proprietary interests ... or because of [confidentiality] arrangements [with 

study participants]. 669 

In Coalition of Battery Recyclers Ass 'n v. EPA, the Court cited American Trucking 

Ass 'ns v. EPA and held, again, that EPA was permitted to rely on studies without making the 

underlying data public.670 They noted, "raw data often is unavailable due to proprietary interests 

of a study's scientific investigators or confidentiality agreements with study 

participants."671 These court cases thus not only upheld EPA's prior practice as permissible, but 

went on to agree that EPA's prior practice was preferable and necessary in light of these other 

policy concerns. 

EPA provides no response to this history, saying only: "Historically, EPA bas not 

consistently observed the policies underlying this proposal. ... ''672 EPA fails explicitly to 

665 83 Fed. Reg. at 18.769. 

"''''FCC\'. Fox Telnision Stations, Inc. 556 U.S. 502. 515 (2009). 6

'

7 283 F.3d 355. 372 (D.C. Cir. 2002). 668 /d at 372 (quoting Particulate Matter NAAQS. 62 Fed. Reg. at 38.689.) (!6') !d. 

"'' 604 F.3d 613.623 (D.C. Cir. 2010). 

''

71 ld at 315. 670 83 Fed. Reg. at 18. 769. 

140 
220 


33371.202

recognize that this proposal changes its past policy and provides no justification in light of the 

compelling opposing points that both EPA and the Courts previously recognized as deterring this 

approach. 

Footnote 4: Exec. Order No. 13777,82 Fed. Reg. 12285 (Mar. 1, 2017). Regulatory reform 

efforts shall attempt to identify "those regulations that rely in whole or in part on data, 

information, or methods that are not publicly available or that are insufficiently 

transparent to meet the standard for reproducibility." 

EPA claims that the proposal is consistent with Exec. Order No. 13777.673 This executive 

order provides no support tor the proposal, and in fact is targeted at eliminating regulations 

including those that are "unnecessary" and "ineffective," which, as our comments detail, the 

proposal clearly would be.674 

This executive order creates a Regulatory Reform Task Force and calls for them to identify 

for repeal, replacement, or modification regulations that among other criteria 

are inconsistent with the requirements of section 5!5 oft he Treasury and General 

Government Appropriations Act. 200! (44 U.S.C. 3516 note), or the guidance issued 

pursuant to that provision, in particular those regulations that rely in whole or in part on data, 

information, or methods that are not publicly available or that are insufficiently transparent to 

meet the standard for reproducibility. 675 

As described in detail in our comments and below, contrary to the inference drawn here in Exec. 

Order No. 13 777, the Data Quality Act and OMS's guidelines issued pursuant to it do not 

require research data and models to be made publicly available for reproducibility purposes in 

order for agencies to rely on the scientific findings and conclusions produced using that data. 

Executive orders cannot override the statutory requirements that EPA use the best 

available science or the laws governing administrative procedure including the APA. The 

proposal's "consistency" with this executive order then cannot serve as a legal basis for EPA to 

adopt an arbitrary and capricious policy that contravenes these best available science 

requirements reflected in the statutes EPA administers. 

Additionally, Exec. Order No. 13777 by its terms requires only the identification of 

regulations that rely in whole or in part on data not publicly available, it says nothing about 

precluding agencies from relying on such studies and does not and cannot require agencies to 

adopt such practices. However, if the proposed rule is to be "consistent" with the executive order 

then it must also follow section 3(e): 

In performing the evaluation described in subsection (d) ofthis section, each Regulatory 

Reform Task Force shall seek input and other assistance, as permitted by law. from 

entities significantly aftected by Federal regulations, including State, local, and tribal 

""83 Fed. Reg. at 18. 769. 674 Exec. Order No. 13777. 82 Fed. Reg. 12285, 12286 (Mar. I. 2017). 670 Exec. Order No. 13777. 82 Fed. Reg. 12285. 12286 (Mar. I. 2017). 

141 
221 


33371.203

governments, small businesses, consumers, non-governmental organizations, and trade 

associations.676 

There is no evidence that EPA consulted with the many stakeholders impacted by this policy, 

including the medical or scientific research communities, which have been largely opposed to 

this policy. 

Footnote 5: Exec. Order No. 13783,82 Fed. Reg. 16093 (Mar. 31, 2017). "It is also the 

policy of the United States that necessary and appropriate environmental regulations 

comply with the law, are of greater benefit than cost, when permissible, achieve 

environmental improvements for the American people, and are developed through 

transparent processes that employ the best available peer-reviewed science and 

economics." 

EPA claims the proposal is consistent with Exec. Order No. 13783.677 However, Exec. 

Order No. 13783 calls for agencies to consider salient information that the proposal has patently 

ignored. Exec. Order No. 13783 calls for agencies to consider the costs and benefits "that are 

based on the best available science and economics" to ensure sound regulatory decisionmaking.678 The proposal provides no analysis of the costs and benefits of implementing this new 

policy, despite there likely being high costs to making research data public with little evidence of 

significant benefits achieved from this policy alone. 

Further, by arbitrarily excluding scientific information that EPA may use in its regulatory 

analyses, the proposal conflicts with the executive order's command to employ the best available 

science and economics.679 

Footnote 6: February 22, 2002 (67 F.R 8453) OMB's Guidelines Ensuring and Maximizing 

the Quality, Objectivity, Utility, and Integrity oflnformation (2002) 

https://www.federalregister.gov/documents/2002/02/22/R2-59/guidelines-for- ensuring-andmaxim izin g-th e-quality-objectivity-utility -and-integrity -of-information. 

EPA wrongly claims that the proposal is "consistent with ... the focus on transparency in 

OMB's Guidelinesfor Ensuring and Maximizing the Quality, Objectivity. Utility and Integrity of' 

Information Disseminated by Federal Agencies."680 To say that OMB's Guidelines have a "focus 

on transparency" that is furthered by EPA's proposal is a gross oversimplification. EPA here 

appears to suggest that transparency is the highest objective to be achieved, divorced from any 

consideration of whether transparency hinders or furthers any other goals. The OMB Guidelines, 

while imposing high standards of quality, objectivity, utility, and integrity of information 

disseminated by Federal Agencies, recognize the need to implement controls ''flexibly, and in a 

" 76 Exec. Order No. 13777. 82 Fed. Reg. 12285. 12286 (Mar. I. 2017). 

''77 83 Fed. Reg. at 18.769. 073 Exec. Order No. 13783,82 Fed. Reg. 16093.16095 (Mar. 3!. 2017). 67" Exec. Order No. 13783, 82 Fed. Reg. 16093 (Mar. J!. 2017). 6' 0 83 Fed. Reg. at 18,769-70. 

142 
222 


33371.204

manner appropriate to the nature ... of the information to be disseminated."681 They suggest 

thinking about transparency strategically to further the aims of good government, unlike the 

proposal, which conflates transparency and quality without consideration of other factors. 

As part of ensuring "objectivity" of information these guidelines encourage agencies 

which disseminate influential scientific, financial, or statistical information, "to include a high 

degree of transparency about data and methods to facilitate the reproducibility of such 

information by qualified third parties." 682 However, they emphasize the need to treat certain data 

differently, due to privacy and confidentiality concerns.683 While they recommend agencies 

''identify the sources of the disseminated information'' they note that this is "to the extent 

possible, consistent with confidentiality protections.''084 Importantly, they take great pains to 

urge agencies not to subject all data to a reproducibility requirement where this could hamper 

agencies.685 They require agencies, instead, to consult with "the relevant scientific and technical 

communities" to identify data that "can practicable [sic] be subjected to a reproducibility 

requirement, given ethical. feasibility, or confidentiality constraints."686 There is no indication 

that EPA consulted with the scientific and technical community, with EPA's own Science 

Advisory Board raising concerns about the proposal and tinding that "lt]his action merits further 

review by the SAB."687 The Guidelines make clear: 

Making the data and methods publicly available will assist in determining whether 

analytic results are reproducible. However, the objectivity standard does not override 

other compelling interests such as privacy, trade secrets. intellectual property, and other 

confidentiality protections.688 

In direct conflict with the reasoning underlying EPA's proposal, the Guidelines 

specifically provide that it is possible to verify the objectivity of information that cannot be made 

publicly available through other types of"robustness checks.''689 As an example, they point to 

the Harvard Six Cities Study, where underlying data could not be made publicly available due to 

confidentiality concerns, but the raw data was released instead to researchers at the Health 

Effects Institute, bound to the same confidentiality requirements as the original researchers, who 

were able to replicate its results.690 In contrast, EPA's proposal would not allow for the 

consideration of this study. 691 

681 Ch\IR ·s Guidelines Ensuring and A1aximi:ing the Quality. Objectivity, Ulility, and integrity of information. 67 

Fed. Reg. 8452. 8453 (Feb. 22, 2002). 680 67 Fed. Reg. 8452. 8460. 68:< fd 

'

84 67 Fed. Reg. 8452, 8459. 685 67 Fed. Reg. 8452. 8460 ("With regard to original and supporting data related thereto. agency guidelines shall not 

require that all disseminated data be subjected to a reproducibility requirement.") 

680 Jd. 

687 Memorandum from SAB Work Group on EPA Planned Actions 1or SAA Consideration of the Undel"iying 

Science (May 12. 2018). 688 67 Fed. Reg. 8452. 8460. 

l:>fN fcf. 

6

'

10 67 Fed. Reg. 8452. 8456. 6'

11 83 Fed. Reg. at 18769 n. 3 (citing to a case challenging EPA's reliance on this study and saying the rule "would 

preclude it from using such data in future regulatory actions.") 

143 
223 


33371.205

The guidelines also recommend agencies recognize that information quality comes at a 

cost, and that agencies should weigh the costs and benefits, which EPA has not done in the 

proposal. 692 

Thus, the proposal completely turns away from OMB's guidelines where OMB 

··urges caution in the treatment of original and supporting data because it may often be 

impractical or even impermissible or unethical to apply the reproducibility standard to such 

data.'' 693 As the comments discuss further, the proposal rule thus unlawfully conflicts with this 

flexible approach that prioritizes agencies' ability to use science as set out by OMB under the 

Information Quality Act. 

Footnote 7: Memorandum for the Heads of Executive Departments and Agencies on Open 

Data Policy-Managing Information as an Asset (https://project-open-data.cio.gov/policymemo/). "Specifically, this Memorandum requires agencies to collect or create information 

in a way that supports downstream information processing and dissemination activities. 

This includes using machine-readable and open formats, data standards, and common core 

and extensible metadata for all new information creation and collection efforts. It also 

includes agencies ensuring information stewardship through the use of open licenses and 

review of information for privacy, confidentiality, security, or other restrictions to release." 

EPA claims the proposal is consistent with OMB's memorandum on Open Data 

Policy.694 This is incorrect, however, as the memorandum supports downstream information 

processing and dissemination-not through complete public disclosure without regard to privacy 

or security-but through instituting a framework of data collection, formatting, and storage that 

allows for public dissemination, if possible.695 Recognizing that not all data can be publicly 

disclosed, and that such data is still useful, the memorandum declares: ·'Whether or not particular 

information can be made public, agencies can apply this framework to all information resources 

to promote efficiency and produce value.''696 

The proposal is thus inconsistent with the memorandum, which stresses the importance of 

information stewardship and "review of information for privacy, confidentiality, security, or 

other restrictions to release."697 When information cannot be released, the memorandum does not 

suggest agencies ignore the information or not rely on it for regulatory purposes. It focuses on 

prescribing agency practices to maximize the downstream usability of data that can be made 

publicly available, including through "using machine-readable and open formats. data standards, 

and common core and extensible metadata for all new inlonnation creation and collection 

etTorts"698 as well as "building or modernizing information systems in a way that maximizes 

interoperability and information accessibility, maintains internal and external data asset 

''"' 67 Fed. Reg. 8452. 8452-53. 

""' 67 Fed. Reg. 8452. 8456. 

""' 83 Fed. Reg. at 18.769-70. 

''05 Memorandum for the Heads of Executive Departments and Agencies on Open Data Policy-Managing 

Information as an Asset, M-13-13 (May 9, 20 I 3). 096 ld. at I. 

r')? Jd at 2. 

698 Jd at l-2. 

144 
224 


33371.206

inventories, enhances information safeguards, and clarifies information management 

responsibilities."099 Thus, while the memorandum centers on how agencies can marginally 

increase the utility ofinfonnation they possess for usc by the public, the proposal turns this on its 

head by advocating for discard of otherwise high quality scientific information if the data 

underlying such information cannot be made publicly available. 

OMB stresses that to achieve "open data," agencies should adopt a presumption in favor 

of openness that is importantly limited by countervailing privacy, confidentiality, security, or 

other valid restrictions. 700 Thus, agencies are expected to "exercise judgment before publicly 

distributing data residing in an existing system by weighing the value of openness against the 

cost of making those data public.''701 The proposal docs not at all weigh the costs, to the agency 

or to the public, of requiring all underlying data to be made publicly available. 

While requiring agencies to adopt measures to strengthen privacy protections and data 

security, the memorandum recognizes serious limitation to data disclosure that EPA completely 

fails to consider. For example, the memorandum mandates that agencies take into consideration 

the ·'mosaic etfect,''702 which EPA does not at all acknowledge-all while making superficial 

and unsupported statements about how privacy concerns can be easily addressed. 703 The 

memorandum recognizes and stresses the challenge of responding to this threat, which requires 

undertaking a "risk-based analysis, often utilizing statistical methods whose parameters can 

change over time, depending on the nature of the information, the availability of other 

information, and the technology in place that could facilitate the process of idcntifieation."704 

OMB importantly notes this analysis "may affect the amount, type, torm, and detail of data 

released by agencies."705 Because it ignores these concerns, EPA's proposal is arbitrary and 

capricious. 

Footnote 8: Plan to Increase Access to Results of EPA-Funded Scientific Research; EPA 

Open Government Plan 4.0; Open Data Implementation Plan; EPA's Scientific Integrity 

(J'J'J Jd at 2. 

700 ld at5. 

701 /d. at 6. 

702 OMB explains: "The mosaic effect occurs when the informalion in an individual dataset, in isolation, may not 

pose a risk of identifying an individual (or threatening some other important interest such as security). hut \.Vhen 

combined \vith other available information, could pose such risk. Before disclosing potential PIT or other potentially 

sensitive infOrmation, agencies must consider other publicly available data-in any medium and from any source--to 

determine 1.vhether some combination of existing data and the data intended to be' publicly released could a!!ow ror 

the identification of an individual or pose another security concern." Memorandum for the Heads of Executive 

Departments and Agencies on Open Oata Policy-Managing Information as an Asset. M-13~13 at 4~5 (May 9, 

2013). 

707 Memorandum lllr the Heads of Executive Departments and Agencies on Open Data Policy-Managing 

lntlmnation as an Asset. M-13-13 at9-10 (May 9. 2013). See, e.g.. 83 Fed. Reg. at 18,770 ('"EPA believes that 

concerns about access to confidential or private information can. in many cases. be addressed ... .'') 704 Memorandum for the Heads of Executive Departments and Agencies on Open Data Policy-Managing 

Information as an Asset. M-13-13 at 9-10 (May 9. 2013). 705 Memorandum tor the Heads of Executive Departments and Agencies on Open Data Policy-Managing 

Information as an Asset. M-13-13 at 10 (May 9. 2013). 

145 
225 


33371.207

Policy; Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and 

Integrity oflnformation Disseminated by the Environmental Protection Agency. 

Rather than acknowledge the drastic change in EPA policy this proposal would 

implement, EPA contrarily claims that the proposal simply "'builds upon prior EPA actions.''706 

None ofthe sources EPA cites here call into question the validity of scientific research for which 

underlying data and models cannot be made public. Indeed, they consistently recognize the 

legitimate limitation on data disclosure while also acknowledging the need for the agency to rely 

on information for which underlying data may not be released without compromising important 

privacy and confidentially concerns. 

I. Plan to Increase Access to Results of EPA-Funded Scientific Research, 

h ttps://www .epa.gov/sites/prod uction/files/20 16-

12/documents/epascientificresearchtransperancyplan.pdf 

Contrary to EPA's claim that the proposal'"builds upon" prior EPA policy, it is actually a 

radical shift away from the view EPA takes in its Plan to Increase Access to Results of EPAFunded Scientific Research, which notes even though "some research data cannot be made fully 

available to the public but instead may need to be made available in more limited ways," this 

availability '"does not affect the validity of the scientific conclusions from peer-reviewed 

research publications."707 The Plan to Increase Access to Results of EPA-Funded Scientific 

Research thus dictates the view EPA has consistently espoused in the past. that it may make data 

available when it can without compromising other critical values, but that it will not exclude 

information from its consideration when it cannot. Yet EPA denies, rather than acknowledging 

and explaining, its new decision to reverse its past stance. 

The Plan requires EPA to make publications resulting from EPA-funded research 

publicly accessible on NIH's PubMed Central (PMC) 708 It aims to "maximize access, by the 

general public and without charge, to digitally formatted data resulting trom EPA funded 

research. while protecting confidentiality and personal privacy, recognizing proprietary 

interests, business confidential if?formation and intellectual property rights, and preserving the 

balance between the relative benefits and costs of long-term preservation and access. "709 It 

recognizes important exceptions for when "the research data cannot be released due to one or 

more constraints, such as requirements to protect confidentiality, personal privacy, proprietary 

interest, or property rights."710 It specifically declares: 'The validity of scientific conclusions 

drawn from research publications or their associated research data, or EPA's ability to consider 

those conclusions and data in its actions. does not depend on compliance with this Plan."711 

''" 83 Fed. Reg. at 18,770. 70' EPA. !'ian ta Increase Access to Results of EPA-Funded Scientific Research 4-5 (Nov. 29. 2016). 

https://\vww.cpa.gov/sites/production/tilcs/20 I 6-12/documcnts/cpascientificresearchtransperancyplan.pdf 708 /d. at 8. 

""/d. at II (emphasis added). 710 !d 

711 !d at 6. 

146 
226 


33371.208

The Plan acknowledges making more limited releases of data "e.g., establishing data usc 

agreements with researchers that respect necessary protections," that fall short of full public 

disclosure. 712 Unlike the proposal, which fails to account for the costs of implementation, the 

plan also acknowledges the need to "balance between the value of providing long-term access 

and its associated costs."713 

The Plan thus further enshrines the view that this rule is unnecessary-where EPA has 

access to data and can release it without compromising other interests, it already does so. It 

further supports the notion that this type of disclosure is not necessary, and will not help, to 

ensure EPA's reliance on valid scientific conclusion. EPA must fully explain its decision to 

deviate from this prior-held stance. 

II. EPA Open Government Plan 4.0, https://www.epa.gov/sites/production/files/2016-

09/documents/20I6epaopengovplan4 Odraft091516updatel.pdf 

EPA's Open Government Plan 4.0 also acknowledges that not all data is releasable to the 

public, even as it aims to '·increase publicly accessible EPA data to support citizens' 

participation in government and promote transparency and accountability of Agency 

operations."714 EPA states in the Plan: ·'By providing releasable information in open and 

machine-readable formats, EPA enables the public and other organizations to better leverage the 

rich wealth of information available.''715 Further, in the Plan EPA notes the stringent 

requirements it has in place on the "collection. access, use, dissemination, and storage of 

personally identifiable information (PIT) and Privacy Act information to prevent unwarranted 

invasions of personal privacy."716 

Rather than suggesting that EPA release underlying data to the public in order to rely on 

scientific information, the Plan only speaks to utilizing a careful approach-with due regard for 

privacy and limitations to data release-to making EPA data more accessible to the public where 

possible. 

III. Open Data Implementation Plan, https://www.epa.gov/sites/production/files/2015-

05/documents/opendatapolicyimplementationplan 030415 finalb.pdf 

EPA's own Open Data Policy, which implements the requirements of White House 

"Open Data Policy Managing Information as an Asset" Memorandum M-13-13, notes that it is 

important to develop "policies and processes to ensure that only appropriate data are released to 

ld. at 4. 7l3Jd 

714 EPA, Open Government Plan./. 0 4 (Sep. 20 16). https://www.epa.gov/sites/production/!11es/20 16-

09/documents/20 16epaopengovplan4 Odraft091516update !.pdf. 715 EPA, Open Government Plan 4.0 4 (Sep. 2016), https://www.epa.gov/sitcs/production/tiles/2016-

09/documents/20 16epaopengovplan4 Odraft091516update l.pdf (emphasis added). 716 EPA. Open Government Plan 4.0 23 (Sep. 2016). https://W\nv.epa.gov/sites/production/tlles/2016-

09/documents/20 16epaopengovplan4 Odratl091516update l.pdf. 

147 
227 


33371.209

the public and made available online."717 To do so, EPA uses different "access levels" for 

different data sets, (public, restricted public, and non-public) and notes that it may not be able to 

publicize data due to "law, regulation or policy, which address privacy, confidentiality, security 

or other valid restrictions."718 

Thus, while the Open Data Policy applies a multi-level, nuanced approach to data 

disclosure, the Proposal completely does away with this by applying a blanket requirement to 

make all underlying data and models publicly available. The Open Data Policy this conflicts 

with, rather than supports, the Proposal. 

IV. EPA's Scientific Integrity Policy, https://www.epa.gov/sites/production/files/2014-

02/documents/scientific integrity policy 2012.pd f 

Contrary to EPA's claim. the Proposal turns away from EPA's Scientific Integrity Policy, 

which stresses "a firm commitment to evidence," endorses use of''the best available science'' 

and "[r]equire[s] reviews ... regarding the content of a scientific product to be based only on 

scientific quality considerations."719 The Proposal, on the other hand, inhibits use of sound 

scientific information and evidence by arbitrarily excluding science from EPA's consideration 

for reasons unrelated to its quality.720 

While the policy "[r]ecognizes the value of independent validation of scientific 

methods''721 and facilitating ''the free flow of scientific information" by making information 

available "including access to data and non-proprietary models underlying Agency policy 

decisions," 722 this is a flexible standard and an ideal to aspire to, not to take priority over other 

competing interests-such as use of the best available science. This measure is meant to 

"facilitate[] the free flow of scientific information" and "expand and promote access to scientific 

information."723 The Proposal, however, limits the free flow of scientific information and 

restricts access to scientific information by restricting EPA's consideration of scientific studies. 

As discussed in our comments, this Administration has blatantly violated key aspects of 

the policy by silencing scientists and the limiting the dissemination of scientific information, 

directly undoing "EPA's longstanding commitment to the timely and unfiltered dissemination of 

its scientific information- uncompromiscd by political or other interference" and goal to 

communicate scientific findings openly and actively to the public. 724 The Scientific Integrity 

Policy is meant to uphold scientific ideals-and prevent arbitrary, politicized decisions about 

which science to utilize-and the Proposal is thus in strong conflict with it. 

717 EPA, Open Data Policy Implementation Plan 4 (Feb. 2015), https://www.epa.gov/sites/production/flles/2015-

05/documcnts/opendatapolicyimplementationplan __ 030415 _ flnalb.pdf. 718 EPA. Open Data Policy !mplememation Plan 4 (Feb. 2015). https://www.epa.gov/sites/production/files/2015-

05/documents/opendatapolicyimplementationplan _ 030415 _ finalb.pdf 719 EPA, Scientific Integrity Polic_v 4. https://w,vw.epa.gov/sites/production/iiles/2014-

02/documents/scientitic integrity policv 2012.pdf. 720 !d. at 3-4. 711 !d. at 4. 

!d 724 !d.. at 5. 

\48 
228 


33371.210

V. Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and 

Integrity of Information Disseminated by the Environmental Protection Agency, 

https://www.epa.gov/quality/guidelines-ensuring-and-maximizing-quality-objectivityutility-and-integrity-information 

EPA's Proposal also does not "build upon" its Guidelines for Ensuring and Maximizing 

the Quality, Objectivity, Utility, and Integrity of Information Disseminated by the Environmental 

Protection Agency. The Guidelines note that it may not be possible for underlying data and 

models to be subject to same degree of disclosure as analytic results, and highlight other methods 

of ensuring the quality of scientific research where disclosure is not possible. 

The Guidelines start by noting, "[t]he mission ofthe EPA is to protect human health and 

safeguard the natural environment upon which life depends" and "[t]he collection, use, and 

dissemination of information of known and appropriate quality are integral to ensuring that EPA 

achieves its mission.'m5 They thus highlight that the controls on data quality exist to allow EPA 

to meet its mission-unlike the Proposal, which makes no mention of EPA's mission or how the 

Proposal would further that mission. Because the Proposal restricts EPA's ability to rely on the 

best available science, it obscures EPA in achieving its mission to set safeguards that are 

protective of human health and the environment, and thus such a statement could not truthfully 

be made. 

While the Guidelines seek to maximize the quality of influential information by 

facilitating the reproducibility of the information-they note: 

In addition, if access to data and methods cannot occur due to compelling interests such as 

privacy, trade secrets, intellectual property, and other confidentiality protections, EPA 

should, to the extent practicable, apply especially rigorous robustness checks to analytic 

results and carefully document all checks that were undertaken. Original and supporting data 

may not be subject to the high and specific degree of transparency provided for analytic 

results; however, EPA should apply, to the extent practicable, relevant Agency policies and 

procedures to achieve reproducibility, given ethical, feasibility, and confidentiality 

constraints. 726 

EPA's Guidelines detail EPA's long-standing position, that it may validate research studies even 

when data cannot be made publicly available-unlike the Proposal, which apparently assumes 

disclosure of underlying data and models is necessary to ensure scientific validity. The 

Guidelines discuss existing programs, such as EPA's Quality System and EPA's Peer Review 

725 EPA, Guidelinesfor Ensuring and Moximi:ing the Quality, Objectivity, Utility, and Integrity of Information 

Disseminated b_v the Environmental Protection Agency 5 (Oct. 2002), https://w\\rw.cpa.gov/guality/guidclines~ 

ensuring~and~maximizing~qua!itv-objectivity~utility~and-integritvwinformation. 

726 !d. at 21. 

149 
229 


33371.211

Policy727 that are in place to assure the high quality of EPA information disseminates. EPA does 

not explain in the Proposal why these other checks are now insufficient. 

Footnote 9: For example, see related policies from the National Science Foundation, 

National Institute of Science and Technology, the National Institutes of Health; and the US 

Census Bureau, which provides secure access to data from several agencies in an 

environment that protects against unauthorized disclosure (https://www.census.gov/fsrdc). 

EPA purports that the Proposal builds upon "the experience of other federal agencies in 

this space" but the citations reveal that is simply not the case.728 To support this statement, EPA 

provides only a hyperlink to a U.S. Census Bureau website along with vague references to entire 

executive branch agencies, with no explanation or discussion of which of their policies EPA 

believes the Proposal is building upon. Without a more specific citation. it is impossible to know 

which policies EPA is referencing or to respond to them meaningfully. 

EPA cites to the U.S. Census Bureau's Federal Statistical Research Data Centers as an 

example of use of secure facilities that allow the Census Bureau to provide controlled access to 

authorized researchers to use restricted-use microdata for statistical purposes only. In order to 

gain access, researchers must obtain Census Bureau Special Sworn Status by passing a moderate 

risk background check and swearing to protect respondent confidentiality for life. While this 

·•solution" meets the U.S. Census Bureau's needs by allowing access to confidential information 

only to researchers whose proposals meet certain criteria, who go through a vetting process, and 

who agree to protect the information, this is done at a cost-which EPA has not accounted forand would not satisfy EPA's requirement to make data and models "publicly available." Thus, 

this example provides no support for the Proposal. 

Footnote 10: These include policies and recommendations from: the Administrative 

Conference of the United States' Science in the Administrative Process Project; National 

Academies' reports on Improving Access to and Confidentiality of Research Data, 

Expanding Access to Research Data, and Access to Research Data in the 21st Century; the 

Health Effects Institute; Center for Open Science; members of the Risk Assessment 

Specialty Section of the Society of Toxicology, the Dose Response Section of the Society for 

Risk Analysis, and the International Society for Regulatory Toxicology and Pharmacology; 

and the Bipartisan Policy Center's Science for Policy Project. 

In footnote 10, EPA lists a number of organizations whose recommendations and policies 

the Proposal allegedly took into consideration. In fact, since the Proposal was published, many of 

these organizations have issued statements opposing the Proposal and contesting EPA's claim 

that their policies and recommendations endorse the Proposal. In this footnote, EPA provided no 

hyper! inks or specific citations for which recommendations and policies it was referencing, 

making it impossible to understand why EPA believed these organizations supported the 

Proposal or to respond to them. 

727 Jd. at 10-13. 728 83 Fed. Reg. at 18,770. 

150 
230 


33371.212

I. The Administrative Conference of the United States' Science in the Administrative 

Process Project 

EPA cites to the Administrative Conference of the United States' Science in the 

Administrative Process Project-Recommendation 20!3-3: Science in the Administrative 

Process. Wendy Wagner, sole author of ACUS's final report Science in Regulation: A Study of 

Agency Decisionmaking Approaches and who served on the panel that produced the 

recommendations strongly opposed the notion that the Proposal builds upon these 

recommendations, saying: "They don't adopt any of our recommendations, and they go in a 

direction that's completely opposite, completely different. ... They don't adopt any of the 

recommendations of any of the sources they cite. I'm not sure why they cited them.'m9 

While ACUS recommends agencies increase transparency of how they rely on scientific 

information and strive to make data underlying scientific information publicly available, 

nowhere do they suggest that agencies should not consider or rely on studies where underlying 

data and models cannot be made publicly available, or that these circumstances make scientific 

information less valid. They instead suggest that information be made publicly available for 

assessment and reproducibility purposes "(c]onsistent with the limitations in the Information 

Quality Act (IQA) guidelines issued by the Office of Management and Budget and its own IQA 

guidelines.'mo They acknowledge valid limitations such as legal protections for privacy, trade 

secrets, and confidential business information.731 Thus, they recommend data be made public 

only "[t]o the extent practicable and permitted by law and applicable policies."732 Unlike the 

Proposal, the recommendation acknowledges that agencies may still use information where 

underlying data cannot be publicly disclosed, and suggest agencies "note that fact and explain 

why they used the results if they chose to do so."733 It thus provides a much more nuanced policy 

recommendation than that outlined in the Proposal-which suggests EPA either find a way to 

make underlying data and models public, despite the numerous potential obstacles and concerns 

in doing so, or completely disregard the research study. 

II. National Academies Improving Access to and Confidentiality of Research Data 

Rather than containing any particular recommendations or policy proposals, this report 

discusses a number of issues pertaining to data disclosure and privacy protection, the tradeoffs 

"between increasing data access on the one hand and improving data security and confidentiality 

729 Robinson Meyer. Scalf Pruitt's New Rule Could Completely Transform the EPA. The Atlantic (Apr. 25. 20 !8), 

https://www .theat !antic .com/sci ence/archive/20 1 8/04/how-the-epas-new-secret -.,cience-ru I e/5 58 8 7 8/. 730 Administrative Cmrference Recommendation 2013-3: Science in the Administrative Process. 78 Fed. Reg. 41,352, 

41.358 (July 10, 20!3). 

Tll Administrative Cm!ference Recommendation 2013-3: Science in the Administrative Process, 78 Fed. Reg. 4 L352, 

41.356 (July 10. 2013). 732 Administrative Cof!.ference Recommendation 2013-3: 5icience in the Administrative Process, 78 Fed. Reg. 41)52, 

41.357 (July 10. 2013). 733 Administrative Conference Recommendation 2013-3: Science in the Administrative Process, 78 Fed. Reg. 41.352. 

41.358 (July 10, 2013). 

I 51 
231 


33371.213

on the other.'m4 and "alternative approaches to limiting disclosure risk while facilitating data 

access the benefits and limitation of various approaches to these issues."735 Thus, rather than 

calling on agencies to rely only on scientific studies where the underlying data and models are 

made public, the report in fact discusses challenges and obstacles to achieving greater data 

disclosure, for which the Proposal provides no substantive or meaningful explanation. 

The report discusses why exercising caution with respect to disclosing confidential 

personal information is so important, because if such information is exposed it could lead to 

being arrested for a crime, being denied eligibility for welfare or Medicaid, being charged 

with tax evasion, losing a job or an election, failing to qualify for a mortgage, or having 

trouble getting into college. Disclosure of a history of alcoholism, mental illness, 

venereal disease, or illegitimacy can result in embarrassment and loss of reputation. Less 

directly, research results based on personal data can cause harm by affecting perceptions 

about a group to which a person belongs. 736 

The report reveals very legitimate reasons why researchers and study participants would be 

reluctant to allow underlying data to be made publicly available-and these reasons in no way 

compromise the validity of the scientific conclusions based upon this data. 

The report also discusses the nuances of selecting methods to protect privacy while 

making underlying data publicly available. For example, while EPA casually makes claims that 

controlled access is an example of a solution in place across federal agencies737-this report 

points out the drawbacks of such an approach: 

The use of restricted access arrangements, which has been deemed necessary to provide 

adequate protection for confidential information about individuals and businesses, results 

in increased costs to conduct research. Custodians of the data files need additional 

resources to process applications, operate inspection systems, staff research data centers, 

and inspect outputs to ensure that disclosure does not occur. Researchers require 

resources to prepare applications for access, to provide appropriate physical security for 

the data, or to visit a secure site. 738 

The report also discusses the difficulty of funding such centers-noting that while the costs are 

currently covered by a combination of federal agency budgets and user fees, including grants 

from the National Science Foundation and National Institute on Aging, federal funding may no 

longer be able to support such efforts.739 EPA's cursory mention to use of restricted access 

facilities as a potential solution to the concerns implicated by the Proposal fail to mention or 

address any of these challenges. 

734 The National Academics, Improving Access tv and Cory(idenliality of Research Data: Report ~fa Workshop, 

National Academies Press 2-3 (2000). 

'-" ld at3. 

" 6 !d. at 19. 

·n7 R3 Fed. Reg. at 18,771. 738 Id at48. 

7}9 Jd 

152 
232 


33371.214

III. National Academies Expanding Access to Research Data: Reconciling Risks and 

Opportunities 

EPA's Proposal in no way takes into consideration the recommendations ofthe National 

Academies report Expanding Access to Research Data: Reconciling Risks and Opportunities. 

This report considers competing approaches to increase use of research data while protecting 

confidentiality, and concludes that "no one way is optimal for all data users or all purposes" and, 

importantly, that "the nation's statistical and research agencies must provide both unrestricted 

access to anonymized public-use files and restricted access to detailed, individually identifiable 

confidential data for researchers under carefully specified conditions."740 In other words, the 

report finds that making data publicly available without restriction while respecting 

confidentiality concerns is not currently feasible or compatible with the missions of federal 

agencies. 

Furthermore. the report mainly concerns itself with how agencies might increase access 

to data in their control and possession to allow for more research in social issues and provide a 

better basis for more informed policy decisions-it does not discuss whether federal agencies 

should make data publicly available in order to allow for independent validation of scientific 

research they rely on for regulatory purposes and thus cannot be a basis for the Proposal.741 

While the report discusses that one of the benefits of data sharing is that it allows for 

""verification, refutation, or refinement of original results," nowhere does the report suggest that 

agencies should rely only on research studies that make data publicly available or that such 

verification is necessary to validate a research study. 742 Indeed, it details a discussion on this 

topic that presents competing views on requirements to make research data available to the 

public to allow for replication. John Bailar raised concerns that researchers would be deterred 

from doing certain kinds of work if they feared it would be subject to ·'hostile scrutiny" and that 

competitors could seize data for their intcrcsts. 743 Others disagreed with this position. 744 

However, EPA failed to engage any of these considerations or at all justify its decision to 

implement a policy that could have severe negative implications. None of the researchers stated 

agencies should disregard the study if underlying data could not be made public. 

The "recommendations" made by tbe report do not endorse EPA's proposal. The report 

provides 15 recommendations in Chapter 5.745 Recommendations 1-4 concern documentation 

and data access and call on agencies to better document how the data they make available is 

used; to use a variety of modes to provide access to data they produce or fund using a 

combination of restricted access to confidential data and unrestricted access to appropriately 

altered public-use data; to support research to guide more efficient allocation of resources among 

different data access modes; and to involve users in planning modes of access to their data?46 

0 The National Academics, E:rpanding Access to Research Data: Reconciling Risks and Opportunities, National 

Academies Press 2 (2005). 

741 /d. at 7. 742 !d. at 39. 743 !d. at I 05-06. 744 See id. at 107. 

"'!d. at 63. 746 /d. at 66-69. 

153 
233 


33371.215

In this Proposal, EPA does nothing to better document use of data that it makes public, 

has only called for a requirement to make research data and models "publicly available" rather 

than recognizing that a variety of modes and levels of access may be necessary, and does nothing 

to support more research into methods of making data more widely available without 

compromising confidentiality-indeed blithely assuming that such means are already available 

and sufficient-and also has not indicated that there has been any widespread call for EPA to 

make such data available or pointed to any comments of users of this data in this process. 

Recommendations 5-8 concern public use data and call on agencies to support research 

on techniques to provide useful innovative public-use data that minimizes the risk of disclosure; 

streamlined procedures to allow researchers access to public-use microdata through existing and 

new data archives; a warning on all public-use data that they are provided for statistical purposes 

only and that any attempt to identify an individual is a violation, and requiring users to attest to 

having read the warning; and restricting access to public-use data to those who agree to abide by 

confidentiality protections, subject to meaningful penalties. 747 

EPA's proposal once again ignores these recommendations that call for greater research 

and a measured approach to making data more widely available. The Proposal provides no ideas 

or methods or support for research that would help strengthen confidentiality protections while 

making data more available. 

Recommendations 9-I 3 concern research data centers, remote access, and licensing 

agreements and call on the Census Bureau to (I) broaden the interpretation of the criteria for 

assessing the benefits of access to data; (2) maintain the continuous review cycle; and (3) take 

account of prior scientific review of research proposals by established peer review processes 

when awarding access to research data centers; for more research on cost effective means of 

providing secure access to confidential data by remote access; increasing use of licensing 

agreements for access to confidential data; working with data users to develop flexible, 

consistent standards for licensing agreements and implementation procedures for access to 

confidential data; and including auditing procedures and legal penalties in licensing agreements 

for willful misuse of confidential data.748 

EPA's proposal does not increase any research into use of remote data centers or 

licensing agreements, simply making passing references to these modes as potential solutions 

with no discussion or explanation-and ignoring the recommendations here suggesting that more 

work is needed to realize their potential. 

Recommendations 14-15 concern maintaining the public's trust and call on agencies to 

give certain basic information about confidentiality and data access to everyone asked to 

participate in statistical surveys; and to support continuing research on the views of data 

providers and the public about research benefits and risks. 749 

!d. at 69-7 4. 748 !d at 74-80. 

"'!d at 80-81. 

154 
234 


33371.216

EPA's proposal does not involve anything that increases the public knowledge about 

confidentiality protections or their views on research benefits and risks. 

Recommendations 16-19 concern training, monitoring, and education to complement 

other protections on data. They call on data collection agencies to provide employees with 

continually updated written guidelines on confidentiality protection and training in 

confidentiality practices and data management and to institute procedures for monitoring 

violations of confidentiality protections practices and confidentiality breaches. They also call on 

educational and professional organizations to provide training in ethical issues for all those 

involved in the design, collection, distribution, and use of data obtained under pledges of 

confidentiality and for the development of strong codes of ethical conduct that reflect the need to 

protection confidentiality750 

EPA's proposal also contains no provisions on increasing training, monitoring, or 

education, within the agency or among researchers to allow for more careful handling of 

confidential data. 

Thus, EPA's Proposal completely ignores the careful research and thinking the National 

Academies and researchers have done on what is needed from federal agencies in order to make 

data more publicly available, and how to do so in a responsible manner. It does not implement 

any of the recommendations in the report, and in no way builds upon this work. 

IV. National Academies Access to Research Data in the 21st Century: An Ongoing 

Dialogue Among Interested Parties: Report of Workshop 

EPA cites to the National Academies' Access to Research Data in the 21st Century: An 

Ongoing Dialogue Among Interested Parties: Report of Workshop as one for which it took into 

consideration "policies or recommendations," despite the fact that this report comes with the 

explicit limitation that: 

The goal of the workshop was not to reach conclusions or recommendations; nor could it 

address other pressing issues beyond the regulatory process, such as protection of 

intellectual property, the influence of broader access on scientific competition, the 

potential for increased administrative burdens and changes in the research process, and 

the challenge of providing data access in an increasingly electronic world. 751 

Thus, this report stresses the many unanswered, challenging policy questions that must be 

addressed as agencies contemplate how to make data publicly available. These are the questions 

EPA should have addressed in its Proposal, but did not. 

750 !d. at 81-84. 751 Science, Technology. and Law Panel; Policy and Global Affairs; National Research Council. Access to Research 

Data in the 21st Centwy: An Ongoing Dialogue Among Interested Parties· Report of Workshop. The National 

Academics Press ix (20ll2). 

155 
235 


33371.217

The Report offers a look into the scientific review process that also calls into question the 

underlying assumption in EPA's proposal-that making data publicly available is necessary to 

ensure the validity of a scientific finding. The report notes that scientific claims "are not 

'binary'" they instead "fall in the category of being uncertain to various degrees."752 The 

reliability of a particular scientific finding can be assessed using various mechanisms, starting 

with an examination of the strength of the design, methods, and statistical results. 753 Then "one 

asks whether there is consistency within the data (pertaining to mechanisms of effect or related 

outcomes) and with other studies and scientific theories."754 Finally, "the robustness ofthe 

findings is evaluated through the use of different analytical approaches."755 

The report describes how studies may be validated through a range of approaches.756 

While it notes that in some cases it is possible to exactly replicate the original study, this is not 

always the case, especially in large epidemiological studies where "repeating a study is 

seldom either possible or desirable."757 Then "replication" can take a variety offonns, not all of 

which require access to underlying data, including: 

Additional analyses done on the data set by the original or collaborating 

Investigators; 

New results generated from older data sets; 

• New studies addressing the same hypothesis; 

• Independent analysis ofthe same data set by different people; 

Monitoring of the results of actions taken on the basis of the findings. 758 

Another form of replication the report describes is 

meta-analysis, which is a systematic strategy for comprehensively describing and 

summarizing a body of research evidence from two or more studies. The goal is to 

produce a quantitative synthesis of the evidence presented in multiple studies that relate 

to a research question. In a typical meta-analysis, all the data used have been published in 

the public domain and are easy to inspect and analyze.759 

The report specifically mentions the Harvard Six Cities Study as an example of a study where 

data could not be made publicly available, but which was verified to allow the agency to 

justifiably rely on it to set important air standards.760 Thus, unlike the Proposal the report 

acknowledges the many different pathways that exist to for researchers to assess other studies, 

and does not suggest that allowing the general public access to underlying data and models is 

necessary. 

750 !d at 5. 3 ld at 7. 

754/d. 

755 /d. 

756/d 

757 fd 758 fd at 7-8. 750 fd at 8. 760 !d. at 8-12. 

!56 
236 


33371.218

One of the panels of the workshop discussed the Shelby Amendment, and public access 

to data underlying agency regulation. A bench scientist expressed concerns that, though the idea 

of sharing data was a good idea, because any person could request information for any reason, 

this mechanism could be used to harass scientists whose work was found objectionable.761 A 

representative ofNIH similarly stated that while sharing data with other researchers was good 

scientific practice, allowing for indiscriminate public access to data serves "little purpose for 

those without the skills to reanalyze it."762 Additionally, access through FOIA does not allow for 

limitations to be put on the use of the data, which is typically available in other data-sharing 

modes.763 A representative from EPA raised issues including: 

The Shelby Amendment. .. raises several questions for the EPA about rule making as a 

legal and deliberative process. At what point should the agency disclose what type of 

regulation is going to be considered or issued? The timing of the release can influence its 

reception. Should the agency use contracts to support the research needed for 

regulations? Contracting, as opposed to grants that support more flexible work, might 

narrow the type of information the agency receives and could possibly limit the scope of 

the science underlying the regulation. 764 

These questions and concerns are highly relevant to the Proposal as well, yet EPA provides no 

indication that it has given them any consideration. 

Finally, a representative from NRDC pointed to other mechanisms that are already in 

place to ensure agencies rely on high quality data. For example, under the Administrative 

Procedure Act, agencies must respond to any comments that raise questions about a scientific 

studies design, performance, or conclusion.765 Courts can determine whether an agency was 

reasonable in its decision to refuse to accept the findings of a study because it could not access 

underlying data or refuses a request from a study participant. 766 EPA does not explain why these 

existing mechanisms are not sufficient to ensure the integrity of the science it relies on. 

V. The Health Effects Institute 

In the original federal register notice, EPA provided no specificity as to which Health 

Effects policy EPA was referring to or why it supported the Proposal. Such a vague and 

unspecified reference does not meet the notice requirements of the APA and other statutes, and 

makes it impossible to respond. 

VI. Center for Open Science 

761 !d. at 14. 762 /d. at 15. 

76.\/d. 

764 !d at 16. 765 !d. at 17. 

766/d. 

157 
237 


33371.219

In the original federal register notice, EPA provided no specificity as to which Center for 

Open Science policy EPA was referring to or why it supported the Proposal. Such a vague and 

unspecified reference does not meet the notice requirements of the APA and other statutes, and 

makes it impossible to respond. 

VII. Members of the Risk Assessment Specialty Section of the Society of 

Toxicology, the Dose Response Section of the Society for Risk Analysis, and the 

International Society for Regulatory Toxicology and Pharmacology 

In the original federal register notice, EPA provided no specificity as to which policy of 

the Members of the Risk Assessment Specialty Section of the Society ofToxicology, the Dose 

Response Section of the Society for Risk Analysis, and the International Society for Regulatory 

Toxicology and Pharmacology EPA was referring to or why it supported the Proposal. Such a 

vague and unspecified reference does not meet the notice requirements of the APA and other 

statutes, and makes it impossible to respond. 

VIII. Bipartisan Policy Center's Science for Policy Project 

In the original federal register notice, EPA provided no specificity as to which Bipartisan 

Policy Center's Science for Policy Project policy EPA was referring to or why it supported the 

Proposal. Such a vague and unspecified reference does not meet the notice requirements of the 

APA and other statutes. and makes it impossible to respond. 

Footnote 11: For example, see related policies from the Proceedings of the National 

Academy of Sciences, PLOS ONE, Science, and Nature 

EPA claims that the Proposal takes into consideration policies adopted by scientific journals, but 

does not specify which "related policies" from these journals.767 While some of these journals 

have adopted certain policies encouraging or requiring researchers to share underlying data for 

the studies they publish, they all allow for exceptions when data cannot be released for 

compelling reasons, such as confidentiality protections. 

Furthermore, the editors of these journals have issued a joint statement opposing the 

Proposal and noting that their policies do not endorse such an approach by EPA. They note that 

some data sets cannot be shared publicly, and that there are still other methods available to verify 

scientific findings. The statement also strongly condemns the notion of excluding scientiftc 

information from consideration when underlying data cannot be made publicly available: 

It does not strengthen policies based on scientific evidence to limit the scientific evidence 

that can inform them; rather, it is paramount that the full suite of relevant science vetted 

through peer review, which includes ever more rigorous features, inform the landscape of 

decision making. Excluding relevant studies simply because they do not meet rigid 

transparency standards will adversely affect decision-making processes. 768 

767 83 Fed. Reg. at 18.770. 768 Jeremy Berget. al., Joint statement on EPA proposed rule and public availability of data, Science (Apr. 30. 

2018). http:llscience.sciencemag.org/content/earlv/20 l8/04/30/science.aau0116. 

158 
238 


33371.220

Thus, EPA cannot claim that the Proposal is in any way supported by the data sharing policies of 

these scientific journals. 

Footnote 12: See: https://www.nature.com/articles/s4I562- OI6-002I; 

http:/ /jou rnals.plos.org/plosrnedicine/ a rticle?id= I O.l37l/jou rnal.prned.0020 I24; 

http:/ /sci en ce.scien cern ag.org/ con ten t/343/6I68/22 9 .long; 

https://www.econornist.com/news/leaders/2I588069-scientific-research-has-changedworld-now-it-needs-change-itself-how-science-goes-wrong.; 

http:/ /strn.sciencernag.org/con tent/8/34l/34Ipsl2.full. 

EPA claims that the Proposal is informed by the policies of scientific journals in response 

to the "replication crisis."769 EPA provides no explanation or evidence to support the fact that 

such a "crisis" is occurring or that EPA's Proposal would do anything to address the crisis. The 

sources EPA cites for this proposition speak to a concern about scientific studies being 

reproducible or replicable due to a number of different conditions related to poor scientific 

practices. While some of the articles speak about making data more available as an ideal to 

aspire to, none of them support the idea that a research study whose underlying data has not been 

made publicly available should. tor that reason alone, be considered invalid. Further, many of 

these articles speak to how current scientific norms do not result in underlying data being 

available, which is a huge barrier to EPA's Proposal that EPA does not at all address. 

I. Marcus R. Munafo et. al, A Manifesto for Reproducible Science, I Nature Human 

Behavior I (20I7) 

Far from suggesting that agencies rely only on scientific studies if the underlying data is 

made public, or even that making underlying data public is necessary to ensure validity of 

scientific conclusions, the article discusses at a high level a number of systemic and cultural 

challenges to reproducible science. By ignoring the nuances of this article and presenting it 

without any explanation as support for its Proposal, EPA runs into the problem the article 

specifically cautions against, warning: "Some solutions may be ineffective or even harmful to the 

efficiency and reliability of science, even if conceptually they appear sensible.'mo 

This article does not endorse the existence of a "replication crisis" and in fact says, 

"[w)hether 'crisis' is the appropriate term to describe the current state or trajectory of science is 

debatable."771 Instead it notes a very different problem than the one EPA appears to target with 

the Proposal. It points broadly to an issue of there being "substantial room for improvement with 

regard to research practices to maximize the efficiency of the research community's use of the 

public's financial investment in research." 772 

760 83 Fed. Reg. at 18.770. 770 Marcus R. Munafo et. al, A Manifesto for Reproducible Science. I Nature Human Behavior I, 7 (2017). 771 ld at I. 772 fda~ I. 

!59 
239 


33371.221

This article makes clear that open data requirements are just one of many solutions and 

steps to take towards increasing efficiency of use of resources and robustness of scientific 

findings-and never suggests that a lack of publicly available underlying data should 

automatically disqualify a research finding from consideration. It discusses a number of other 

improvements including protecting against cognitive biases through blinding, improving 

methodological training, implementing methodological support, encouraging collaboration and 

team science, promoting study pre-registration, improving quality of reporting, diversifying peer 

review, and changing incentives to promote efficient and effective research instead of just 

innovative outcomes. 

While the article recognizes transparency as a "scientific ideal"773 it notes many 

challenges that currently exist to achieving this ideal, which EPA does not at all address. The 

article notes, "In reality, science often lacks openness: many published articles are not 

available to people without a personal or institutional subscription, and most data, materials 

and code supporting research outcomes are not made accessible, for example, in a public 

rcpository.'m4 It further finds "substantial barriers to meeting these ideals, including vested 

financial interests (particularly in scholarly publishing) and few incentives for researchers to 

pursue open practices." Nowhere does the article suggest that the many scientific studies for 

which data is not available due to prevailing scientific norms and practices be completely 

discarded. These challenges suggest that many studies EPA wishes to rely on may not be able 

to meet the rigid requirements of EPA's proposal severely restricting the science EPA can 

use, degrading the quality of its decision-making. 

Marcus R. Munafo, lead author on this paper, has since published a piece specifically 

dismissing science policy approaches that overemphasize the importance ofreplication. 775 It 

states that the overemphasis on replicability is detrimental to science-that "[i]f a study is 

skewed and replications recapitulate that approach, findings will be consistently incorrect or 

biased."776 Instead, the author suggests that "an essential protection against flawed ideas is 

triangulation'' or "the strategic use of multiple approaches to address one question.''777 This 

involves looking at a broad base of different scientific studies and does not require underlying 

data to be made publicly available, not individual studies based on whether or not they can be 

replicated.778 By excluding scientific studies from EPA's consideration, the Proposal 

overemphasizes the value of replication to the detriment of being able to evaluate a study in the 

context of many other studies examining the same issue through a variety of methods. The 

Proposal may well lead to reliance on Jess robust science and is thus arbitrary. 

77.1 !d at 5. 

774 !d 

Marcus R. Munaf6 & (Jcorgc DaYcy Smith, Rohusl research needs man_v liw.!s f!luridence. Nature (Jan. 23. 

20 I X). https:i/w\\w.nature.com/articles/d41586-018-01023-3#ref-CR3. 776 !d. 

m !d. 

mid 

160 
240 


33371.222

II. John P.A. Joannidis, Wily Most Published Research is False, 2 PLoS Medicine 0696 

(2005) 

The article suggests"the high rate of nonreplication (lack of confirmation) of research 

discoveries is a consequence of the convenient, yet ill-founded strategy of claiming conclusive 

research findings solely on the basis of a single study assessed by formal statistical significance, 

typically for a p-value less than 0.05."779 It looks at a number of different contributors to false 

positive findings and discusses solutions to this problem. Importantly, it stresses the need to 

focus on large studies. consider the totality of the evidence, and improve understanding of prestudy odds. 780 These solutions each involve considering more evidence and more scientific 

studies to contextualize any one given study. Nowhere does the article suggests requiring 

underlying data be made public or fewer studies be considered. EPA's proposal contrarily 

emphasizes data disclosure above all other practices for ensuring scientific integrity-and will 

result in fewer studies being considered to shed light on the scientific truth. 

The author of this article has specifically criticized EPA's Proposal, saying that, if it is 

finalized, "science will be practically eliminated from all decision-making processes" and 

"[r]egulation would then depend uniquely on opinion and whim.'' 781 The author highlights the 

inherent problem in EPA's Proposal, that "most of the raw data from past studies are not publicly 

available" and that indeed "[i]n a random sample of the biomedical literature (2000-2014) none 

of268 papers shared all ofthcir raw data ... [and] [o]nly one shared a full research protocol."m 

EPA has not addressed this major issue that suggests the Proposal would bar EPA from relying 

on massive amounts of scientific research. The article notes that reproducibility issues vary 

across the disciplines and that in many areas in which EPA operates, a solid and large foundation 

of scientific research has produced credible and widely-affirmed findings, including "in fields 

such as air pollution and climate change."783 Even in these other fields, however, it firmly states 

that "simply ignoring science that has not yet attained such standards, is a nightmare."784 

III. Marcia McNutt, Reproducibility, 343 Science 229 (2014), 

h ttp://science.scienccmag.org/conten t/343/6168/22 9 .long 

EPA cites an announcement by Science that, in response to reports "that a troubling 

proportion of peer-reviewed preclinical studies are not reproducible;ms Science is adopting new 

policies requiring authors making submissions to the journal to disclose "whether there was a 

pre-experimental plan for data handling (such as how to deal with outliers), whether they 

conducted a sample size estimation to ensure a sufficient signal-to-noise ratio, whether samples 

were treated randomly. and whether the experimenter was blind to the conduct of the 

779 John P.A. Joannidis. Why Most Published Research is False, 2 PLoS Medicine 0696 (2005). 780 fd at 0700-0701 781 John P.A. Joannidis. All science should inform policy and regulation, 15 PLOS Med I, 2 (May 3, 20 18), 

http://journals.plos.org/plosmedicine/article?id= I 0.13 71/journal.pmed.l 002576. 782 /d at 1. 783 fd at2. 784 /d at2. 785 Marcia McNutt, Reproducibility. 343 Science 229 (20 14 ), 

http:// science.sciencemag.orgl content/3 4 316 16 8/229 .long. 

161 
241 


33371.223

experiment."786 While the article considers steps to increase reproducibility of science, it notes 

that data availability is not a necessary or sufficient step to ensure credibility of research 

findings, and that "ultimate responsibility lies with authors to be completely open with their 

methods, all of their findings, and the possible pitfalls that could invalidate their conclusions."787 

EPA's Proposal ignores the ability to assess studies through these other important indicators to 

assure their validity. 

VI. How Science Goes Wrong, Economist (Oct. 21, 2013), 

h ttps:/ /www .eco nom ist.co m/n ews/lead ers/21588069-scien tific-research-has-changedworld-now-it-needs-change-itself-how-science-goes-wrong 

This article opposes the view that verification of a study depends solely on the underlying 

data being made publicly available. While it identifies that much scientific research is unable to 

be replicated, the solution it proposes include tightening standards, particularly in statistics, 

registering research protocols in advance and monitoring them, and: "lw]hcre possible, trial data 

also should be open for other researchers to inspect and test.'' 788 Thus, even to the extent it 

discusses data availability, it suggests data should be open for other researchers, as opposed to 

the public, and recognizes this may not always be possible.789 

VII. SteveN. Goodman, What does research reproducibility mean?, 8 Science 

Translational Medicine I (2016), 

http://stm.sciencemag.orglcontent/8/341/341psl2.full 

Rather than saying anything about agencies relying only on scientific studies where 

underlying data is made public, this article discusses the importance of clearly defining key 

terms in the discussion about scientific reproducibility, noting that there is a lack of standardized 

definitions of terms such as "reproducibility, replicability, reliability, robustness, and 

generalizability."790 This raises a key issue of vagueness in EPA's proposal-EPA does not 

provide definition for key terms such as "independently validate" or "reproducible'' and 

confusing mentions a "replication crisis" while citing to articles that speak to a "reproducibility 

crisis." 

While providing definitions for these various terms, the article notes that there terms all 

represent various methods of attempting to verify studies to ensure "scientific claims based on 

scientific results are true" and cautions against "treating reproducibility as an end in itself--

rather than as an imperfect surrogate for scientific truth." 791 Instead, it promoted the view of 

looking across studies to ''assess their cumulative evidential weight."792 EPA Proposal thus 

directly contradicts the suggestions of this article. 

786 !d 

787 !d 

788 l!ow Science Goes Wrong, Economist (Oct. 21, 2013). https://www.cconomist.com/ncws/leadcrs/21588069-

scientlfic~research-has·changed·\VOrld*nowwit·needs-change-itself-hmv-scicncc-goes-wrong. 

789 !d. 

790 SteveN. Goodman. JYhat does research reproducibility mean?, 8 Science Translational Medicine 1 (2016), 

http://stm.sciencemag.org/contenti8/34li341ps 12.full. 79) !d 

!d. at 3. 

162 
242 


33371.224

Footnote 13: EPA has not consistently followed previous EPA policy (e.g, EPA's Scientific 

Integrity Guidance, referenced above) that encouraged the use of non-proprietary data and 

models. 

While EPA in a footnotes suggests that EPA has not consistently followed EPA's EPA's 

Scientific Integrity Policy encouraging the use of non-proprietary data and models, it misses the 

fact that EPA's policy was not written as an absolute standard, but was intended to be a tlexible 

one. The policy states only that "the use of non-proprietary data and models are encouraged, 

when feasible, to increase transparency."793 EPA must thus explain and justify its deviation from 

its prior tlexible approach that the Proposal now imposes. 

Footnote 14: https://www .whitehouse.gov/wp-content/uploads/2017 /11/2005-M-05-03-

Issuance-of-OMBs-Final-Information-Quality-Bulletin-for-Peer-Review-December-16-

2004.pdf 

The Proposal appears to issue a requirement for independent peer review of all pivotal 

regulatory science used to justify regulatory decisions, consistent with the requirements of the 

OMA Final Information Quality Bulletin for Peer Review. EPA cites to OMB's Final 

Information Quality Bulletin for Peer Review, explaining existing peer review requirements that 

nowhere does EPA suggest are not already being complied with. 

As discussed in our comments, there is some vagueness as to whether the Proposal 

maintains, expands, or narrows these already existing requirements. OMS's bulletin underwent a 

rigorous stakeholder process including response to comments on multiple drafts from 

stakeholders, a federal agency workshop at NAS, outreach to major scientific organizations and 

societies, a formal interagency rcview. 794 EPA's Proposal has not gone through nearly the same 

level of review, or as our comments detail, even met the minimum legal requirements for 

consultation and review. OMS's guidance further provides that agencies should consider the 

"tradeoffs between depth of peer review and timeliness"795 This includes considering a benefitcost framework for peer review that takes into account "the direct costs of the peer review 

activity and those stemming from potential delay in government and private actions that can 

result from peer review."796 As our comments detail. EPA has not provided any meaningful 

benefit-cost analysis ofthe Proposal. Thus, it would be improper and in contlict with OMS's 

guidance for EPA to be expanding the peer review requirements through this Proposal. 

Footnote 15: February 22, 2002 (67 FR 8453) OMB's Guidelines Ensuring and Maximizing 

the Quality, Objectivity, Utility, and Integrity of Information (2002) 

793 EPA, Scientific Integrity Policy at 4. 794 Final information Quality Bulletin for Peer Review, 70 Fed. Reg. 2664 (Jan. 14, 2005). 795 ld at 2.668. 796 Id at 2.668 

163 
243 


33371.225

https://www.federalregister.gov/documents/2002/02/22/R2-59/guidelines-for-ensuring-andmaximizing-the-gualitv-objectivity-utility-and-integrity-of-information. 

As discussed above in the Section on footnote 6, EPA's attempt to align its proposal with 

OMB's guidelines is misguided. 

Footnote 16: See examples from the U.S. Department of Health and Human Services, 

National Institute of Standards and Technology, U.S. Department of Education, and the 

U.S. Census Bureau. 

In the original Proposal EPA provided no specific "examples" and this vague cite 

provided very little direction about what EPA was referencing here-making it impossible to 

review these examples or respond to them. 

Footnote 17: https://www .hbs.gov/hipaa/for-professionals/privacy/special-topics/d eidentification/index.html. 

EPA states that other agencies have tools to de-identify information private information, 

but fails to recognize that these methods are not transferable to EPA's context.797 EPA links to 

guidance on de-identification requirements under HIPAA. This guidance provides two methods 

for de-identifying data: (I) expert determination method, where an expert determines that, after 

application of statistical and scientific principals and methods, the risk is very small that the 

information alone or with other available information could be used to identifY the subject; and 

(2) the safe harbor method, requiring that a number of identifiers are removed. The first method 

requires case-by-case work and EPA has provided no information regarding how EPA could 

implement it or how much it might cost and thus the feasibility of requiring researchers or EPA 

to de-identify data this way is questionable. The second method requires removal of much 

information useful for research that may be necessary to be able to independently validate the 

research, so it is unclear that it would satisfy the Proposal's demands. Furthermore, the safe 

harbor method has been shown to provide potentially insufficient privacy protections. 798 

Footnote 18: https://www.nap.edu/catalog/11434/expanding-access-to-rcscarch-datareconciling-risks-and-opportunities. 

In this footnote, EPA cites to a report by the National Academies for the proposition that 

"The National Academies have noted that simple data masking, coding, and de-identification 

techniques have been developed over the last half century ... " 799 This incorrectly makes it seem 

as though the National Academies have identified simple techniques to de-identify data for 

public release without compromising personal piracy. A full review of the report reveals the 

797 83 Fed. Reg. at 18.771. 

" 8 Latanya Sweeney. Ji Su Yon. Laura Perovich, Katherine E Boronow, Phil Brown. and Julia Green Brody, Reidentifcation Risks in H!PAA Safe Harbor Data: A Study qf Data From One Environmental Health Study. 

Technology Science (August 28. 2017). 799 83 Fed. Reg. at J 8,771; National Research Council, E:.Xpanding Access to Research Data: Reconciling Risks and 

Opportunities. National Academies Press (2005). 

164 
244 


33371.226

opposite is true, that The National Academies in fact recognize that complex, evolving, and yet 

undeveloped techniques are needed to resolve these concerns. It offers recommendations that are 

intended to improve upon existing techniques, indicating that this area is under constant change 

and many advances are left to be made. ROo Further, the report notes this improvement requires 

·'strong partnership between the research community and statistical and research agencies in the 

design of innovative research on disclosure avoidance techniques and data access modalities and 

in the implementation of the advances that result from such research."801 The Proposal takes no 

steps towards advancing design of new techniques or providing resources to undertake all that 

needs to be done to make the Proposal remotely feasible. 

Further, the Report notes that a changing landscape is making it increasingly difficult to 

apply past techniques to sufficiently protect data from identification, saying: "Initially, relatively 

simple data masking techniques, such as top coding income amounts ... were used to generate 

restricted data products[,] [d]uring the last decade the increasing risks of confidentiality 

breaches have led researchers to develop increasingly sophisticated methodologies for restricted 

data products."802 They state, "more research is clearly needed to assess the relative ability of 

different masking methods, and of synthetic data, to reduce the risk of disclosure while 

preserving data utility."803 EPA does not acknowledge these newly emerging concerns. 

The National Academies recognize the current limitations of producing restricted data 

that sufficiently limits identifiability to allow it to be made publicly available in a useful form. 

They note that "well-informed policy making" requires ·'[r]esearch using detailed confidential 

data" that cannot be made public-which the Proposal fails to acknowledge to the detriment of 

the quality of EPA's policy decisions. 804 Just because certain information cannot be made public 

for legitimate reasons does not mean the government should refuse to use it to inform policy. 

And much of the data useful for environmental and health research is particularly sensitive-the 

report notes there is increased vulnerability in "[d]ata with geographic detail, such as census 

block data" and longitudinal data obtained in panel surveys, which is often salient in 

environmental research805 In the meantime, the National Academies state that more work is 

needed to allow "[h]igh-quality public-use files" that still assure "the inferential validity of the 

data while safeguarding their confidentiality."806 

They also point to broader implications of not implementing sufficient privacy 

protections that EPA does not consider at all may result from the Proposal. The quality of data 

collected is likely to suffer as "[i]t is essential that respondents believe they can provide accurate. 

complete information without any fear that the information will be disclosed inappropriately."807 

Essentially, the report leaves as an open question "decisions about how much disclosure risk is 

acceptable in order to achieve the benefits of greater access to research data involve weighing the 

800 /d at35, 

801 /d at35. 802 !d. at 27 803 !d. at 28. 804 /d. at 2. 

sos !d. at 22. 

B06 !d. at 2. 

soJ /d. at 5!. 

165 
245 


33371.227

potential harm posed by disclosure against the benefits potentially foregone." 808 Thus, EPA 

wrongfully points to this report as supporting the notion that simple techniques exist to address 

privacy concerns. The report recommends only more research to reduce risks and increase data 

utility along with consultation with data users and providers about these issues-which the 

Proposal does not implement and thus the report does not support the Proposal. 809 

Footnote 19: https://www.cep.gov/content/dam/cep/report/cep-final-report.pdf; 

h ttps :/ /www .n a p.ed u/ cat a Iog/2465 2/in novations-in-fed era 1-sta tistics-co m bin ing -datasources-while-protecting-privacy; https://www.nap.edu/catalog/24893/federal-statisticsmultipledata-sources-and-privacy-protection-next-steps. 

EPA claims that "the National Academies and the Bipartisan Commission on Evidence 

Based Policy have discussed the challenges and opportunities for facilitating to secure access to 

confidential data for non-government analysts."810 The proposal does not explain how these 

examples are relevant, as there is no indication that secure access to underlying data would meet 

the requirements of making underlying data "publicly available." Further. even if it were 

relevant, a review of the sources cited reveal that they do discuss many challenges in this 

space-which the Proposal does not at all address-and provide no support for the Proposal. 

I. Commission on Evidence-Based Policymaking, The Promise of Evidence-Based 

Policymaking (2017) 

This report centers on how to enhance infrastructure to increase the access and use of data 

between federal agencies to support government policy-making, rather than increase public 

access to data to non-governmental analysts for purposes of independently validating regulatory 

science! 11 Further, its focus is to help efforts to make more data available for government 

purposes to better inform policies. The Proposal on the other hand seeks to make data available 

to validate individual studies while ultimately making less data available for EPA to consider as 

it creates policies. 

To the extent the report does speak to making more data publicly available, it envisions an 

entirely new framework to provide adequate privacy protections. Chapter Three of the report 

discusses increasing threats to privacy as ·'the amount of information about individuals that is 

publicly available has grown and the technology that can permit unauthorized re-identification 

has improved.''812 It notes that forming solutions to this problem while preserving the quality of 

data is difficult, and that a challenge is "ensuring that enhanced statistical disclosure methods do 

not change the data in ways that increase the difficulty of reproducing research results." It thus 

specifically notes that protecting confidentiality can be in tension with allowing data to be used 

for reproducibility purposes. 

"'Id at 62. 809 /d. 

810 R3 Fed. Reg. at l R.771. 811 Commission on Evidence-Based Policymaking. The Promise of Evidence-Based Po/icymaking (2017). 812 !d. at 54-55. 

166 
246 


33371.228

The report recommends: (I) amending federal statutes to require Federal departments to 

conduct a comprehensive risk assessment on de-identified confidential data intended for public 

release and release de-identified confidential data subject to the Privacy Act and CIPSEA only 

after a disclosure review board approves the release and publicly provides the risk assessment 

and a description of steps taken to mitigate risk; (2) federal departments to adopt state-of-the-art 

database, cryptography, privacy-preserving, and privacy-enhancing technologies for confidential 

data used for evidence building; (3) federal departments assign a senior official the responsibility 

for coordinating access to and stewardship of the department's data resources; (4) new 

legislation ensuring that data acquired under a pledge of confidentiality arc kept confidential and 

used exclusively for statistical purposes.813 The Proposal does not discuss or contribute to any of 

these efforts. 

Chapter Four recognizes that some data cannot be made publicly available without 

sacrificing the utility of the evidence and thus sets forth recommendations for creating a new 

National Secure Database Service to allow researchers to access "detailed data that cannot be 

made publicly available, and only for exclusively statistical purposes."814 This report thus 

implicitly recognizes the value of using confidential data to "securely generate evidence about 

government policies and programs."815 While transparency is a crucial goal, using data that 

cannot be made publicly available can help inform government policies in important ways. 

The Report details the many obstacles to making data publicly available, and ultimately 

concludes that much more work is needed in this area, none of which is being furthered by 

EPA's Proposal. 

II. NAS, Innovations in Federal Statistics: Combining Data Sources While Protecting 

Privacy (20 17) 

This report provides recommendations to increase sharing and usc of data by the federal 

government and between agencies. 816 It places maintaining privacy and confidentiality at the 

forefront. The report provides a discussion of the benefits and challenges to allowing external 

researchers to access data held by government agencies. This assumes that agency has access to 

data in the first place-which may not be the case with the studies EPA wishes to rely on that 

would be barred by its Proposal. 

The report notes multiple risks to privacy and confidentiality from data breaches, identity 

theft, and the threat from the ability to combine multiple data sources to re-identify anonymized 

data as more and more data is made publicly available.817 The solutions that the report proposes 

to minimize these risks include: data minimization, restricted data, restricted access (including 

licensing agreements, federal statistical research data centers, nongovernment data enclaves). 818 

813 1d at47. 

'" ld at 66. 815 Jd at 68. 816 NAS. Innovations in Federal Statistics: Combining Data Sources While Protecting Privacy, National Academics 

Press (20 17). 817 ld at 76-79. 818 fd at 82-88. 

167 
247 


33371.229

The Proposal does not allow for data minimization since it is aimed at making public complete 

underlying data that is likely to involve salient personally identifiable information for an 

unlimited amount oftime. 819 Data restriction involves "removing explicit identifiers and 

applying a variety of statistical disclosure limitation methods to the dataset to reduce the risk of 

disclosure."820 However, because these techniques "decrease the precision of the variables in the 

dataset and ... introduce errors" it is unclear that they would preserve data for independent 

validation while also sufficiently protecting privacy. 821 Restricted access involves using 

"administrative procedures and technology to restrict who can access the dataset and what kinds 

of analyses can be done with the data to reduce the risk ofdisclosure."822 This specifically limits 

access to data from the general public, which seemingly would not meet the requirements of 

EPA's proposal. Thus, EPA has not addressed how it would meet any of the challenges raised in 

this document. 

III. NAS, Federal Statistics, Multiple Data Sources, and Privacy Protection: Next Steps 

(2017) 

This report is not directly relevant as it discusses ways to combine diverse data sources 

from government and private sector sources and the privacy issues that arise from combining 

multiple data sets. 823 The purpose of the report is to help "federal statistical agencies examine 

and evaluate data from alternative sources and then combine them as appropriate to provide the 

country with more timely, actionable, and useful information for policy makers, businesses, and 

individuals."824 EPA's proposal will in fact restrict the information that EPA can use. 

The report notes that the "privacy status of data is dynamic over time, that datasets that 

are not individually identifiable today may in the future become individually identifiable" with 

the availability of new techniques and auxiliary data. 825 It notes that as data sets are linked, these 

privacy threats increase. 826 The Proposal does not discuss or address threats to privacy from data 

linkages. 

The panel highlighted a number ofthreats to privacy and data security, including from 

security threats and inferential disclosure, and concluded ''there is awareness of weaknesses of 

current statistical disclosure limitation methods, but the feasibility for federal statistical agencies 

of implementing new technologies, such as differential privacy, has not been clearly 

demonstrated.''827 Finally, they state: 

810 !d. at 82·83. 

'

00 ld at 83. 

"'!d. 

822 !d. at 85. 823 NAS, Federal Statistics, Multiple Data Sources. and Privacy Protection: Next Steps. National Academies Press 

(2017). 

'

24 !d. at2. 

'

25 !d. at 71. 

s:"ld. at 72. 

" 7 ld. at 105. 

168 
248 


33371.230

Overall, much work, interaction, and collaboration will be needed across the various 

disciplines and stakeholders as agencies seek to move forward to provide stronger 

privacy protection for the data they either collect from respondents or acquire access to 

from other administrative and private-sector sources for statistical purposes. It will be 

critical for there to be robust discussions of the implications of this approach for all 

stakeholders and these discussions will need to be informed by concrete examples to help 

everyone understand how use of these technologies will affect them. 828 

The report notes that in order to provide greater access to data much more research and resources 

are needed. The Proposal identifies no such resources or processes needed to develop needed 

methods and techniques to allow for greater data disclosure. 

Footnote 20: For example, see policies or recommendations of publishers Taylor & Francis, 

Elsevier, PLOS, and Springer Nature 

EPA cites to "policies or recommendation" of several journals that require data be 

deposited in public data repositories as an example of the Proposal's requirement of data 

availability. 829 EPA provided only a list ofjournals with no reference to any specific policies 

making it difficult to respond fully to this statement. 

Each of these journals, however, has exceptions to its data availability requirements when 

there are valid reasons preventing authors from making their data publicly available via a public 

data repository. Further, the editors of these journals released a joint statement that explains why 

their policies with regards to data availability should not be used to support a policy by a federal 

agency that would in fact restrict the scientific studies it could rely on. 830 Given the vastly 

different contexts and aims of federal agencies and scientific journals when it comes to making 

data publicly available, journal policies should not inform EPA's direction. None of these 

journals claims that lack of data availability in itself calls into question the validity of a scientific 

conclusion based on that data-and thus these policies do not support the Proposal. 

Footnote 21: For example: https://osp.od.nih.gov/scientific-sharing/requesting-access-tocontrolled-access-data-maintained-in-nih-designated-data-repositories-e-g-dhgap/; 

https://www.census.gov/fsrdc 

As examples of controlled access to data in federal research data centers, EPA cites to the 

National Institutes of Health's policy for requesting access to controlled-access data maintained 

in NIH-designated data repositories and the U.S. Census Bureau's website on Federal Statistical 

Research Data Centers, secure facilities providing authorized access to restricted-use microdata 

for statistical purposes only. NIH requires researches to be a tenure-track professor, senior 

828 fd at 106. 829 83 Fed. Reg. at 18,771. 830 Jeremy Berget. al., Joint statement on EPA proposed rule and public ami/ability of data, Science (Apr. 30, 

20 18), http://science.sciencemag.ol'g/contentlearl v/20 18/04/30/science.aauO 116. 

169 
249 


33371.231

scientist, or equivalent and go through required procedures prior to gaining access.831 The U.S. 

Census Bureau requires researchers to obtain Census Bureau Special Sworn Status, which 

requires passing a moderate risk background check and swearing to protect respondent 

confidentiality for life, with significant financial and legal penalties under Title 13 and Title 26 

for failure to do so. 832 

It is unclear how these policies are informing EPA's proposal. EPA's proposal would 

require data to be made "publicly available," and these forms of restricted access specifically do 

not make data publicly available. They require significant resources and infrastructure and 

careful thought about who will be permitted to access such data and under what conditionsnone of which EPA has provided any discussion of in the Proposal. 

Footnote 22: These recommendations are consistent with those of Lutter and Zorn (2016). 

https:/ I www .mercatus.org/system/files/Mercatus-Lu tter-Pu blic-Access-Data-v3. pdf. we re. 

EPA cites to a working paper by Randall Lutter and David Zorn as supporting the 

proposition that "EPA should collaborate with other federal agencies to identify strategies to 

protect confidential and private information in any circumstance in which it is making 

information publicly available. These strategies should be cost-effective and may also include: 

Requiring applications for access; restricting access to data for the purposes of replication, 

validation, and sensitivity evaluation; establishing physical controls on data storage; online 

training for researchers; and nondisclosure agreements.''833 

Lutter and Zorn reference these strategies as ones agencies could use to minimize the 

risks to personally identifiable information when agencies make data publicly available. 834 

However, EPA's proposed regulations do not discuss or propose implementation of any of these 

strategies. The Proposal would result in a rule that mandates only that data be made "publicly 

available" without any possibility for more restricted release. As the comments discuss, EPA has 

further not consulted with other federal agencies on this Proposal. 

Lutter and Zorn additionally do not argue that agencies should immediately disregard 

studies where data cannot be made publicly available, and provide alternative procedures 

agencies should utilize in those cases when still relying on studies.m In a separate statement on 

the HONEST Act. which contains similar requirements as the Proposal, Lutter and Zorn stated 

that the legislation "should also allow agencies to regulate in instances where they do not possess 

data.''836 While these additional procedures they recommend agencies follow could still be overly 

831 NIH. Requesting Access to Controlled-Access Data Maintained in NIH-Designated Data Repositories (e.g .. 

dbCaP). https ://osp .od .nih. gov /scientific-shari ng/rcq uesti n g-access-to-controlled-access-d ata-mai ntai ned-in-nihdesignated-data-repositories-e-g-dhgap/ (last accessed Aug. 10. 2018). 

BJ:: U.S. Census Bureau, Secure Research Environment, 

https://www.census.gov/aboutl~prmlfsrdc/aboutlsccure rdc.html (last accessed Aug. 10. 2018). 

m 83 Fed. Reg. at 18.77!. 8

" Randall Lutter & David Zorn. On the Benefits and Costs of Public Access to Data Used to Support Federal 

Policy Making, Mercatus Working Paper 31 (Sept. 2016). 535 Jd. at 32-33. 836 Randall Lutter and David Zorn, The Data That Our Government Uses Must be li·ansparent, SmartRegs (Mar. 13. 

20 17). https:Jismartregs.org/Jhe-data-that-our-government-uses-must-be-transparen.\:£~a 16b3 de 19d. 

170 
250 


33371.232

burdensome and barriers to EPA promulgating important safeguards, it is important to note that 

even they see the dangers in a rule that would force the agency to disregard studies when 

underlying data could not be made public. 

Footnote 23: https://www.nap.edu/catalog/11434/ expanding-access-to-research-datareconciling-risks-and-opportunities. 

The Proposal claims "The benefits EPA ensuring that dose response data and models 

underlying pivotal regulatory science are publicly available in a manner sufficient for 

independent validation are that it will improve the data and scientific quality of the Agency's 

actions and facilitate expanded data sharing and exploration of key data sets."837 EPA cites to a 

National Academies report. This report does speak to many benefits of making data available to 

researchers, including helping to maintain and improve data quality; 838 promoting new research 

and exploration of new questions using existing data;839 and allowing for verification, refutation. 

or refinement of original resu Its. 840 

However, the report simply considers the benefits of making data publicly available in a 

broad sense, it docs not consider the issue in the Proposal-which is that new data is not 

necessarily being made publicly available that was not before, and at the same time EPA's 

consideration of scientific research is being limited. Thus, it does not consider the costs to 

government policy-making that come from EPA's refusing to consider scientific research where 

underlying data is not publicly available. Since it is questionable whether the Proposal will result 

in any new data being made available to the public, and certain that it will result in EPA's 

ignoring valid scientific findings, it is unlikely that this Proposal will "improve the data and 

scientific quality of the Agency's actions" as EPA claims. 

Footnote 24: https://www.mercatus.org/system/files/Mercatus-Lutter-Public-Access-Datav3.pdf. 

EPA cites to a paper by Randall Lutter and David Zorn for its analysis that "an increase 

in existing net benefits from greater reproducibility, which, if it occurred, would cover the costs 

of obtaining the data and making the data available."841 However, there arc important limitation 

to this analysis that seriously call this conclusion into question. 

First, the statement that EPA cites to is taken out of context. The entire sentence is: 

''More specifically, we can calculate an increase in existing net benefits from greater 

reproducibility, which, if it occurred, would cover the costs of obtaining the data and making the 

data available."842 This statement is not a conclusion that the benefits of making publicly 

337 83 Fed. Reg. at 18.772. 

""The National Academics, Expanding Access to Research Data: Reconciling Risks and Opportunities, National 

Academies Press 48 (2005). 8)

9 /d at38. 340 Id at 39. 841 Randall Lutter & David Zorn. On the Benefits and Costs of Public Access to Data Used to Support Federal 

Policy Making. Mercatus Working Paper (Sept. 2016). 842 Id at 27. 

171 
251 


33371.233

available data underlying research that federal agencies use to promulgate significant public 

polices would outweigh the costs. It is describing the figure that Lutter and Zorn go on to 

calculate-the threshold level of increase in net benefits required by this policy to equal the costs 

of implementation. They find that "an improvement in net benefits of 0.02 to 2.08 percent would 

imply that the net benefits of requiring data access are positive." 843 They themselves note that 

this estimate "fall[ s] short of proving that the benefits outweigh the associated costs.''844 

Their analysis itself is suspect because it differs greatly from the cost estimate provided 

by the Congressional Budget Office for H.R. 1430, Honest and Open New EPA Science 

Treatment Act of2017. The CBO estimated that, if the agency were to choose to rely only on 

studies that met the Act's requirements from the outset, implementing this legislation would cost 

about $5 million from 2018-2022.845 They assumed it would cost $10,000 per study to make data 

available to enable use of studies.846 They estimated costs of at least $100 million per year if 

EPA were to continue to rely on as many studies to support its actions as it has done in recent 

years 847 An older cost estimate from CBO on a prior version of the HONEST Act estimated that 

it would cost "about $250 million a year for the next few years."848 This assumed that EPA 

would spend from $10,000 to $30,000 per study to make the data available and that EPA would 

reduce the number of studies it relies on by about one-half. 849 

Zlttter and Lorn calculated an alternative amount for the costs to EPA of this legislation. 

They find that "the total cost to the EPA for data collection and public accessibility would be 

$2,558 per study, or about 26 percent of the $10,000 per study cost estimated by CB0."850 They 

used estimates that EPA reported under the Paperwork Reduction Act for time that entities in the 

chemical industry would need to spend to comply with EPA's Health and Safety Data Reporting 

Rule (40 C.F.R. 716). 851 While they purport that the requirements of that rule are similar to the 

activities that EPA would undertake to comply with the HONEST Act and similar legislation, 

they provide no further basis for this. 852 Given the great discrepancy between their and CBO's 

estimates, it is unclear that their estimate sufficiently accounts for the numerous costs associated 

with EPA locating underlying research data not currently in its possession and upgrading it to 

enable it to be made publicly available. 

They also rely on questionable assumptions in their calculation. They assume that "given 

modern technology, by the time research has been published. almost all relevant underlying data 

8--13Jd 

84-1/d at29. 805 Congressional Budget Office, Cost Estimate: HR. 1-130. Honest and Open New EPA Science Treatment 

(/!ON EST) .-Jet of 2017 (Mar. 29. 20 17), https://www.cbo.gov/systcm/filcs/ll5th-congress-20 17-

20 18/costestimate/hr1430.pdf. 

" 6 !d. at 3. 

847 !d. atJ. 848 Congressional Budget Of!ice, Cost Estimate: HR. /030 Secret Science Reform Act <f 20/5 (Mar. II. 2015), 

https://www.cbo.gov/sites/defaultlfiles/114th-congress-20 15-20 16/costestimate/hr I 030.pdf. 840 !d at 3 .. 850 Randall Lutter & David Zorn. On the Benefits and Costs of Public Access to Data Used to Support Federal 

Poli(V Making, Mercatus Working Paper 23 (Sept. 2016). 

"'Jd. at21. 

85:! ld 

172 
252 


33371.234

and computer code and models will be in electronic format" so time spend photocopying studies 

will be reduced. 853 This does not consider that EPA may want to rely on older studies where all 

relevant information is not available in electronic, easily accessible formats. They provide 

unsupported estimates for activities that EPA would need to undertake to comply with HONEST 

Act-like legislation that has no corresponding requirement in EPA's Health and Safety Data 

Reporting Rule-such as estimating 10 hours for EPA to format unformatted data for public 

access. 854 

They additionally produce their own estimate for the number of studies that EPA relics 

on each year, looking at materials posted in dockets on regulations.gov and coming to a total of 

18,000 pieces of scientific research per year.855 CBO estimated 50,000 scientific studies per 

year 856 Assuming that EPA continued to rely on all 18,000 studies per year, Zutter and Lorn 

came to total implementation costs of about $46 million per year, far below the estimate by CBO 

assuming EPA still relied on at least half of the studies it does currently. Thus, one should view 

this cost estimate with suspicion, and there is no reason it should be relied on over CBO's cost 

estimates and does not suffice for EPA providing its own cost benefit analysis. 

May 25, 2018 Memorandum 

On May 25, 2018, EPA provided a memorandum that provided additional hypcrlinks for 

some of the sources cited in the footnotes. 857 

Footnote 9 

o National Science Foundation: https://www.nsf.gov/bfa/dias/policy/dmp.jsp 

o National Institute of Science and Technology: https://www.nist.gov/open 

o National Institutes of Health: https://grants.nih.gov/policy/sharing.htm 

The hyperlinks that EPA provides fail to point to any relevant policies that support EPA's 

Proposal. First, EPA links to the National Science Foundation's policies requiring investigators 

who receive NSF grants to share research data with other rcsearchers. 858 Importantly, they are 

only to release privileged or confidential information "in a form that protects the privacy of 

individuals and subjects involved" and NSF may make adjustments or exceptions when needed 

853 Id at 22. ss4 Id 

855 /d. at 24. 856 Congressional Budget Ollice Cost Estimate: H.R. 1430, Honest and Open New EPA Science Treatment 

(HONEST) Act of2017 (Mar. 29, 2017). https://www.cbo.gov/systemifilcs/115th-congress-2017-

2018/costestimate/hrl430.pdf. 3 857 May 25, 2018 Memorandum Re: Omitted Hyperlinks tor Footnotes in the Proposed Rule (Docket lD No. EPAHQ-OA-2018-0259) 

858 NSF. Disseminating and Sharing of Research Results, httos://www.nsf.gov/bla/dias/policy/dmp.jsp (last accessed 

Aug. 10. 2018). 

173 
253 


33371.235

"to safeguard the rights of individuals and subjects, the validity of results, or the integrity of 

collections or to accommodate the legitimate interest of investigators."859 

EPA links to the National Institute of Science and Technology policy on sharing data 

arising from NlST-funded research. 860 The plan clearly exempts "[p]ersonnel and medical 

information and similar information the disclosure of which would constitute a clearly 

unwarranted invasion of personal privacy" from being subject to the data sharing policy 861 

EPA also cites to The National Institutes of Health. The hyper link links to a webpage 

consisting of a number of policies dictating sharing of NIH-funded research with no clarification 

of which policy EPA is referring to or why it is relevant to the Proposal. While NIH policies do 

in many cases require data from NIG-funded research to be shared publicly-these policies place 

protection of personal information at the forefront and thus include controls such as controlled 

access, de-identification of information, data aggregation and allow exceptions when data cannot 

be made publicly available. 

These examples all deal with policies to share data tha! the agencies have access to and 

the ability to share-because they deal with federally-funded research. EPA's Proposal, on the 

other hand, applies to all data whether or not EPA has the data in its possession or is authorized 

to release it. They all speak to making data available to increase its utility, not to making data 

available specifically for the purposes of independent validation ofresearch results. which 

requires data be available on a more granular level that makes privacy protection more difficult. 

Further. EPA already has policies in place to make publicly available data that is produced by 

research it funds. Also, none of these policies address regulating how the agencies themselves 

rely on or use scientific information. Thus the Proposal in no way ''builds upon" the efforts they 

represent. 

Footnote 10 

o Administrative Conference of the United States' Science in the Administrative 

Process Project: https:/ /www .acus.gov/research-projects/science-ad ministrativeprocess 

o Improving Access to and Confidentiality of Research Data: 

https://www.nap.edu/read/9958 

o Expanding Access to Research Data: https://www.nap.edn/catalog/11434/expandingaccess-to-research-data-reconciling-risks-and-opportnnities 

o Access to Research Data in the 21st Century: 

https:/ /www .na p.ed u/catalog/1 0302/access-to-research-data-in-th e-2lst-cen tu ry-anongoing 

o Health Effects Institute: https://www.healtheffects.org/system/files/AppendixD-dataaccess_3.pdf 

859 NSF. Chapter Xi- Other Post A1ttard Requirements and Considerations, 

https://mvw.nsrgov/pubs/policydocs/pappgl7 1/pappg ll.jsp#XID4 (Jan. 30. 2017). 860 NIST, Public Access to NIST Research, https://www.nist.gov/open (last accessed Aug. 10. 2018). 8" 1 NIST, Managing Public Access to Results of Federally Funded Research Policy 1·2 (Jun. 26. 2015). 

https://mvw.nist.gov/sites/defa~lt/tiles/documcnts/20 18/06/ 19/!inal p 5700.pdf. 

174 
254 


33371.236

o Center for Open Science: 

https://osf.io/x2w9h/? ga=2.15543670.1160736397.1518527893-

7763321 06.1518527893 

o Members of the Risk Assessment Specialty Section of the Society of Toxicology, the 

Dose Response Section of the Society for Risk Analysis, and the International 

Society for Regulatory Toxicology and Pharmacology: 

http://www .isrtp.org/GMU%20WEBINAR _DEC_ 20 13/GMU%20Study%20Docum 

ent4.pdf 

o Bipartisan Policy Center's Science for Policy Project: 

http://bipartisanpolicy.org/wpcontent/uploads/sites/default/files/BPC%20Science%20Report%20fnl.pdf 

I. The Health Effects Institute, https://www.healtheffects.org/systemlfiles/ AppendixDdata-access_3.pdf 

EPA provides a link to the HE! Policy On The Provision Of Access To Data Underlying 

HEI funded Studies. This policy is "to provide access expeditiously to data for studies that it has 

funded and to provide that data in a manner that facilitates review and verification of the work 

but also protects the confidentiality of any volunteers who may have participated in the study and 

respects the intellectual interests of the original investigator of the work."862 It is written to be 

consistent with OMB Circular A-ll 0, which requires agencies to respond to FOIA requests for 

data underlying federally supported research used to develop federal agency actions with the 

force and effect of law. EPA already has policies in place to make public the data underlying 

research that it funds, and already must comply with OMB Circular A-110, thus, it is unclear 

how this Proposal builds upon this policy. 

Furthermore, the policy specifically excludes "personal and medical information and 

similar information that is personally identifiable, and the disclosure of which would constitute a 

clearly unwarranted invasion of personal privacy, such as information that could be used to 

identify a particular person in a research study" and requires the requestor to pay reasonable 

costs. In this manner, it further deviates from the Proposal. 863 

II. Center for Open Science, 

https://osf.io/x2w9h/? _ga=2.15543670.1160736397.1518527893-7763321 06.1518527893 

EPA links to the Center for Open Science's 2017-2020 Strategic Plan. 864 While the 

strategic plan outlines COS's own mission to "increase openness, integrity, and reproducibility 

of scholarly research'' and to meets its goal of creating "a future scholarly community in which 

the process, content, and outcomes of research are openly accessible by default" nothing in this 

862 HEL APPENDIX D. HE/ POLICY ON THE PROVISION OF ACCESS TO DATA UNDERLYING HEIFCJ.VDED 

STUDIES, https://www.healtheffects.org/system!filcs/ AppendixD-data-access 3 .rdf (last accessed Aug. I 0, 20 18). 863/d. 

864 Center for Open Science, Strategic Plan, https://osf.iolx2w9hi? ga=2.15543670.1160736397.1518527893-

776332106.1518527893. 

175 
255 


33371.237

strategic plan suggests anything like EPA's Proposal. 865 It does not discuss barring use of studies 

or ensuring access to underlying data-and thus is completely irrelevant to the Proposal. 

III. Members of the Risk Assessment Specialty Section of the Society of Toxicology, the 

Dose Response Section of the Society for Risk Analysis, and the International 

Society for Regulatory Toxicology and Pharmacology: 

http://www.isrtp.org/GMU%20WEBINAR_DEC_2013/GMU%20Study%20Docum 

ent4.pdf 

EPA links to a survey conducted by the Center for Media and Public Affairs and Center 

for Health and Risk Communication at George Mason University. 866 They surveyed members of 

the Risk Assessment Specialty Section of the Society of Toxicology, the Dose Response Section 

of the Society for Risk Analysis, and the International Society for Regulatory Toxicology and 

Pharmacology. However, the survey thus does not represent any official recommendation or 

policy position from these professional organizations, and represent only the views of the 

members who chose to participate in the survey. 

Thus, while the survey found 69% of those surveyed "regard it as "very important" for 

assessors to have access to underlying raw data for the most critical studies in order to 

independently analyze their results," this should be viewed in the rightful context.867 The survey 

did not ask whether agencies should continue to rely on scientific studies where the underlying 

data cannot be made public or independently analyzed. The survey question further appears to 

have only asked whether researchers assessing studies should have access to underlying data to 

independently analyze results, not whether underlying data should be made publicly available. 

Further, the Dose Response Section of the Society for Risk Analysis has since submitted 

a comment to EPA that states this footnote and the claim that EPA makes that the Proposal took 

into consideration these recommendations and policies is "inaccurate" and that "the 'DoseResponse Section [sic] of the Society for Risk Analysis' has never adopted any 'policies or 

recommendations' on this or any other topic."868 They have asked that EPA remove all 

references to the organization and make clear in the comment response for this rule that ""third 

party Organizations' whose policies and recommendations were considered do not include 

the Society for Risk Analysis or the Dose-Response Specialty Section." 

The Society for Toxicology similarly have said this survey does not constitute support 

from the Specialty Section or the SOT as a whole, and requesting "that any and all references to 

"members of the Risk Assessment Specialty Section of the Society of Toxicology" be removed 

"' Id at 6. 806 George Mason University. Expert Opinion on Regula/my Risk Assessment (Dec. 6. 2013). 

http://www.isrtp.org/GMU%20WEBINAR DEC 2013/GMU%20Study%20Document4.pdf. 857 ld. at 2-3. 

"'8 Comment from Weihsueh A. Chiu, Chair. Dose-Response Specialty Group, Society for Risk Analysis. Docket lD 

No. EPA-1-IQ-OA-2018-0259 (May 24. 2018). 

176 
256 


33371.238

from the Final Rule."869 They also specifically comment that "invalidating data solely on the 

basis of public availability is inappropriate."870 

IV. Bipartisan Policy Center's Science for Policy Project, 

http://bipartisanpolicy.org/wpcontent/uploads/sites/default/files/BPC%20Science%20Report%20fnl.pdf 

EPA provides a hyper! ink to the Final Report of the Science for Policy Project Improving 

the Use of Science in Regulatory Policy.871 This report makes a number of recommendations, 

none of which endorse the Proposal. In relevant part, Recommendation Three suggests 

"Agencies and their scientific advisory committees should cast a wide net in reviewing studies 

relevant to regulatory policy. and should make their methods for filtering and evaluating those 

studies more transparent."872 They urge agencies to increase availability of data and information 

on research studies and subject all studies relied on in the formulation of regulation to be subject 

to the requirements of the Shelby Amendment and OMB Circular A-ll 0 regardless of who 

funded the study. 873 Importantly, those requirements contain important exception for 

confidentiality and privacy concerns--and thus do not support the Proposal. 

This recommendation is also aimed at increasing use of science in regulatory policy, and 

does not suggest that agencies not rely on studies where those data access requirements cannot 

be met because of other concerns. It also highlights that the use of CBI to prevent access to data 

appears to be overused and urges agencies to make procedures more stringent to allow only for 

legitimate claims ofCBI-which EPA does not address in its Proposal. 874 

Recommendation Four states: "The federal government, universities, scientific journals 

and scientists themselves can help improve the use of science in the regulatory process by 

strengthening peer review, expanding the information available about scientific studies, and 

setting and enforcing clear standards governing conflict of interest."875 As part of this 

recommendation, the report ''Federal agencies, universities and journals should encourage or 

require on-line publication of the methods and data underlying published scientific studies."876 

However, it once again does not say that agencies should not consider research studies where this 

is not possible due to privacy or other compelling reasons. 

Wendy Wagner, who served on the panel that produced the recommendations has stated: 

''They don't adopt any of our recommendations, and they go in a direction that's completely 

809 Comment from Leigh Ann Burns Naas. Society ofToxicology. Docket ID No. EPA-HQ-OA-2018-0259 (May 

25. 2018) at 1. 

s7o !d. at 2 871 Bipartisan Policy Center, Science for Policy Project. improving the Use ~(Science in Regulatmy Policy (Aug. 5. 

2009), http://bipartisanpolicy.orglwp-content/uploadslsites/default/filcs/RPC%20Sciencc%20Report%20fnl.pdf. 812 /d at41. 

873 !d. 874 /d. at 43. 875 /d. at 45. 

"" ld at 46. 

177 
257 


33371.239

opposite, completely different .... They don't adopt any of the recommendations of any ofthe 

sources they cite. I'm not sure why they cited them."877 

Footnote 11 

o Proceedings of the National Academy of Sciences: 

http://www.pnas.org/page/authors/journal-policies#xi 

o PLOS ONE: http://journals.plos.org/plosone/s/data-availability 

o Science: http://www .sciencemag.org/au thors/science-journals-editorial-policies 

o Nature: http://www.nature.com/authors/policies/data/data-availability-statementsdata-citations.pdf 

While EPA links to journal policies that encourage or require, in some instances, sharing 

data, they contain exceptions when privacy would be compromised. 878 The editors of these 

journals issued a joint statement opposing the ProposaL They note that some data sets cannot be 

shared publicly, and that there are still other methods available to verify scientific findings. The 

statement also strongly condemns the notion of excluding scientific information from 

consideration when underlying data cannot be made publicly available: 

It does not strengthen policies based on scientific evidence to limit the scientific evidence 

that can inform them; rather, it is paramount that the full suite of relevant science vetted 

through peer review, which includes ever more rigorous features, inform the landscape of 

decision making. Excluding relevant studies simply because they do not meet rigid 

transparency standards will adversely affect decision-making processes. 879 

Thus, journal policies encouraging the sharing of underlying data do not support a proposal by a 

regulatory agency to exclude from consideration studies when the underlying data is not publicly 

available. 

Footnote 16: 

o U.S. Department of Health and Human Services: https://www.hhs.gov/hipaa/forprofessionals/privacy/special-topics/de-identification/index.html 

o National Institute of Standards and Technology: 

https://nvlpubs.nist.gov/nistpubs/ir/2015/NIST.IR.8053.pdf 

o U.S. Department of Education: 

h ttps://studen tprivacy .ed.gov/sites/default/files/resou rce _ document/file/data_ deident 

ification_ terms. pdf 

o U.S. Census Bureau: https://www.census.gov/about/adrm/linkage/technicaldocumentation/processing-de-identification.html 

EPA suggests the examples linked to could address concerns about privacy and 

confidentiality arising from the ProposaL However, the cited sources provide no assurance that 

Robinson Meyer. Seal/ Pruitt's New Rule Could Completely Tramform the EPA. The Atlantic (Apr. 25. 2018), 

https:/ /www .the at! antic .com/science/arch ive/20 I 8/04/how-thc-epas-new-sccret -scicncc-rule/5 58 878/. 878 See discussion below on footnote 20. 87 '~ Jeremy Berg d. al., Joint statement on EPA proposed rule and public availability of data, Science (Apr. 30. 

2018), http://science.sciencemag.org/content/carly/20 18/04/30/science.aauO I 16. 

178 
258 


33371.240

the Proposal could be implemented to expand disclosure of personal data without serious risks to 

privacy. 

I. U.S. Department of Health and Human Services, https://www.hhs.gov/hipaa/forprofessionals/privacy/special-topics/de-identification/index.html 

EPA first points to guidance on de-identification requirements under HIPAA. This 

guidance provides two methods for de-identifying data: (I) expert determination method, where 

an expert determines that, after application of statistical and scientific principals and methods, 

the risk is very small that the information alone or with other available information could be used 

to identify the subject; and (2) the safe harbor method, requiring that a number of identifiers are 

removed. The first method requires case-by-case work and EPA has provided no information 

regarding how EPA could implement it or how much it might cost and thus the feasibility of 

requiring researchers or EPA to de-identify data this way is questionable. The second method 

requires removal of much information useful for research that may be necessary to be able to 

independently validate the research, so it is unclear that it would satisfy the Proposal's demands. 

Furthermore, the safe harbor method has been shown to provide potentially insufficient privacy 

protections. 880 

II. National Institute of Standards and Technology, 

https://nvlpubs.nist.gov/nistpubs/ir/2015/NIST.IR.8053.pdf 

EPA links to a NIST document entitled De-Identification of Personal Information as a 

potential solution to address concerns about confidentiality and privacy. 881 This document 

discusses different techniques and issues with de-identification of personal information. 

However, the document does not discuss de-identification of personal information specifically 

for the purposes of making research data publicly available for independently validating 

scientific studies. The document instead notes that: 

The purpose of de-identifying data is to allow some uses of the de-identified data while 

providing for some privacy protection by shielding the identity of the data subjects. These 

two goals are antagonistic, in that there is a trade-off between the amount of deidentification and the utility of the resulting data. However, de-identification opens up 

new uses for the data that were previously prohibited due to privacy concerns. It is thus 

the role of the data controller, standards bodies, regulators, lawmakers and courts to 

determine the appropriate level of security, and thereby the acceptable trade-off between 

de-identification and utility. 882 

EPA completely fails to note this obstacle, that as data is stripped of identifiable material it also 

loses utility to researchers. EPA cites to broad privacy protection techniques without explaining 

gao Latanya Sweeney) Ji Su Yon, Laura Perovich, Katherine E Boronow, Phil Brown, and Julia Green Brody. Reidentifcation Risks in HIPAA Sqfe Harbor Data: A Study of Data From One Environmentai!Jealth Study. 

Technology Science (August 28, 2017). 881 Simson L. Garfinkel. De-Identification oj?ersonallnjormation (NISTIR 8053), NIST (Oct. 2015). 

https :/In vi pubs.n i st. gov /nistpu bs/ir/20 15/NIST .IR.805 3. pdf. 880 !d. at 11-!2. 

179 
259 


33371.241

whether they could be applied to protect privacy while still allowing enough utility in the data set 

to allow for independent validation as required by the Proposal. 

The document notes many of the challenges to protecting privacy including that: "deidentification approaches based on suppressing or generalizing specific fields in a database 

cannot provide absolute privacy guarantees, because there is always a chance that the remaining 

data can be re-identified using an auxiliary dataset."883 The harms of data linkages and increasing 

difficulty to preserve privacy as more and more information about individuals is made available 

is another challenge that EPA has not addressed. 

III. U.S. Department of Education, 

https:/ /stu den tprivacy .ed.gov /sites/default/files/resource_ document/file/data_ deidentificatio 

n_terms.pdf 

EPA links to a document of the Privacy Technical Assistance Center, Data Deidentification: An Overview of Basic Terms, which provides a high-level overview of key terms 

and practices to help educational agencies and institutions comply with the Family Educational 

Rights and Privacy Act (FERPA). 884 EPA has not explained why the requirements ofFERPA are 

applicable here. This document is concerned with data disclosure that occurs "when schools, 

districts, or states publish reports on student achievement or share students' data with external 

researchers" not to make information publicly available for independent validation.885 Thus its 

unclear that methods used to de-identify but preserve data for those purposes would be adequate 

in this context. 

For example, one of the methods that the U.S. Department of Education uses for disclosure 

avoidance for tabular data is to not release information for any cell that has a size below some 

minimum, which essentially means not disclosing information where there are small numbers in 

a certain ccll. 886 This could obviously lead to a loss of information that would prevent a deidentified data set from being used to independently validate research findings. 

IV. U.S. Census Bureau, 

https://www.census.gov/about/adrm/linkagc/tcchnical-documentation/proccssing-deidentification.html 

EPA provides a link to a website titled Data Ingest and Linkage that details the U.S. 

Census Bureau's approach to linking data across many records held by the Bureau, permitting 

more detailed information to be linked back to one individual to allow for analysis and research. 

The website links to a working paper that describes the method by which the Bureau assigns a 

unique person identifier to records it holds that enables it to link records together to create the 

"'/d. at 5. 884 U.S. Department of Education. Privacy Technical Assistance Center. Data De-identification: An Overview of 

Basic Terms (Oct. 20 12), 

https://studentprivacy.ed.govlsitesldefault/files/resource document/!ile/data deidentilication terms.pdf. 

8K5fd. 

886 ld at 4. 

180 
260 


33371.242

final file. 887 It is totally unclear how this process on linking together records is a solution that 

EPA could implement to protect privacy of individuals when disclosing data as it concerns how 

to identify data to specific people-not how to make data available while protecting their 

privacy. 

Footnote 20: 

o Taylor & Francis: https://authorservices.taylorandfrancis.com/data-repositories/ 

o Elsevier: https://www.elsevier.com/authors/author-services/research-data 

o P LOS: http:/ /journals. plos.org/p losone/s/data-avai labi I ity 

o Springer Nature: https:/ /www .springernature.com/ gp/authors/research-datapol icy/repositories 

EPA cites to "policies or recommendation" of several journals that require data be 

deposited in public data repositories as an example of the Proposal's requirement of data 

availability. 888 While these journals have policies that encourage authors to deposit data in public 

data repositories, they all have important exceptions in cases where this is not feasible or ethical. 

The hyper! ink for Taylor & Francis links to a page that provides information about how 

to find public data repositories to submit date to in order to comply with journal sharing policies. 

However, Taylor & Francis' basic data sharing policy "which applies across many of [their] 

journals" does not require data be submitted to a public data repository, but "encourages authors 

to share and make data open where this does not violate protection of human subjects or other 

valid subject privacy concerns.''889 Thus, this policy is flexible and allows exceptions for when 

privacy concerns are at stake. 

The hyper! ink for Elsevier links to a page providing general information about data 

sharing. While the web page notes that researchers "are increasingly encouraged, or even 

mandated, to make ... research data available, accessible, discoverable and usable," it also 

provides important qualifications. 890 It notes, "there are times when the data is simply not 

available to post or there are good reasons why it shouldn't be shared."891 In these cases, authors 

arc encouraged to provide a data statement explaining why the data cannot be shared. 

The hyperlink for PL.OS links to a page describing PL.OS's data availability policies. It 

explains, "PLOS journals require authors to make all data underlying the findings described in 

their manuscript fully available without restriction, with rare exceplion."892 The policy 

recommends deposition of the data into a public repository, however, it recognizes that there are 

887 Deborah Wagner & Mary Layne, The Person Identification Validation System (PVS): App~ving the Center for 

Administrative Records Research and Applications· (C1RRA) Record Linkage Software. CARRA Working Paper 

Series. Working Paper# 2014-01. U.S. Census Bureau (July I, 2014). 888 83 Fed. Reg. at 18.771. 889 Taylor & Francis Author Services, Understanding our data sharing policies. 

https:l/authorservices.tavlorandfrancis.com/understanding-our-data-sharing-policics/ (last accessed Aug. 10. 2018). 890 Elsevier. Sharing research data. https://www.elsevier.com/authors/author-services/research-data (last accessed 

Aug. 10. 2018). 891 /d. 

892 !'LOS One, Data Availability, http://journals.plos.org/plosone/s/data-availability (last accessed Aug. 10, 2018). 

181 
261 


33371.243

instances when this may not be ethical or legal, for instance because the "underlying data pose 

privacy or legal concerns e.g., where data might reveal the identity or location of participants."893 

In these instances, it allows an exception to this policy. 

The hyper! ink for Springer Nature links to a page listing recommended repositories. 

While Springer Nature's data policies support data sharing via public data repositories, it notes, 

·'reasonable restrictions on data availability are permitted to protect human privacy, biosafety or 

respect reasonable terms of use for data obtained under license from third parties."894 

893 ld 

:.N4 Springer Nature, Research Data Poficies FAQs. hHps://ww\v,springernature.com/gp/authors/research-datapolicv/fags/12327154 (last accessed Aug. 10. 2018). 

182 
262 


33371.244

Appendix B. Provisions of Federal Environmental Statutes Requiring EPA to Consult 

With Other Federal Agencies in Implementing Key Programs 

Consultation Provisions in Clean Air Act 

Section Section Title Consultation Requirement 

§ 118(c) President's Air Quality (c) Prior toAdvisory Board and (1) issuing criteria for an air pollutant under section 

Advisory Committees 108(a)(2) 

(2) publishing any list under section lll(b)(I)(A) or 

112(b)(1)(A), 

(3) publishing any standard under section 111 or section 

112, or 

(4) publishing any regulation under section 202(a). 

The administrator shall, to the maximum extent practicable 

within the time provided, consult with appropriate advisory 

committees, independent experts. and Federal departments and 

agencies. 

§ 103 Research, Investigation, Consult with other Federal agencies to coordinate research and 

Training, and other avoid duplication of activities 

Activities 

§lOS( a) Air Quality Criteria and Consult with Federal agencies to issue information on air 

Control Techniques pollution control techniques 

§lOS( c) Air Quality Criteria and "[A]fter consultation with the Secretary of 

Control Techniques Transportation ... update the June 1978 Transportation-Air 

Quality Planning Guidelines and publish guidance on the 

development and implementation of transportation and other 

measures necessary to demonstrate and maintain attainment of 

national ambient air quality standards." 

§108(!)(1) Air Quality Criteria and Consult with Secretary of Transportation to provide information 

Control Techniques "regarding the formulation and emission reduction potential of 

transportation control measures related to criteria pollutants and 

their precursors." 

§ 112(d)(9) Hazardous Air Pollutants Allows Administrator not to list radionuclide emissions if 

Administrator detennines, after consultation with Nuclear 

Regulatory Commission (NRC), that NRC regulations already 

provide an ad-"9._uate margin of safety. 

§122 Listing of Certain Consult with NRC before listing any nuclear or nuclear byUnregulated Pollutants product material 

§169A Visibility Protections for Consultation with Department of Interior and Federal Land 

Federal Class 1 Areas Managers for regional haze determinations 

§231 (a)(2)(B)(i) Aircraft Emission Consult with Federal Aviation Administration on aircraft engine 

Standards emission standards 

§250 (d) General Provisions Consult with Department of Energy (DOE) and Department of 

Transportation (DOT) in carrying out Administrator's duties 

under the this part (Clean Fuel Vehicles) 

§404( f)( I )(A) Energy Conservation and Consult with Secretary of Energy to determine Qualified 

Renewable Energy Energy Conservation Measure 

183 
263 


33371.245

§507(b)(3)(A) Small Business Consult with SBA Administrator to determine which category 

Stationary Source of small business sources could be exempted 

Technical and 

Environmental 

Compliance Assistance 

Program 

Consultation Provisions in Clean Water Act 

Section Section Title Text 

§304(c) Information and Consult with appropriate Federal and State agencies to issue information 

Guidelines on pollution-reducing procedures and operating methods to implement 

standards of performance under &306. 

§304( d) (I )-(2) Information and Consult with appropriate Federal and State agencies to publish the amount 

Guidelines of reduction attainable through secondary treatment and information on 

alternative waste treatment management techniques. 

§304(e) Information and Consult with appropriate Federal and State agencies to publish 

Guidelines supplemental regulations to control plant site runoff, leaks/spillage, 

sludge/waste disposal, and drainage 

§304(1) Information and Consult with Federal and State agencies to issue guidelines for evaluating 

Guidelines nonpoint sources and methods to control pollution from those sources. 

§307(a)(7) Toxic Consult with Federal departments and agencies prior to publishing 

Pretreatment regulations pursuant to this section 

Effluent 

Standards 

g404(d)(l) Disposal of Administrator must consult with Federal agencies on regulations 

Sewage Sludge providing guidelines for the disposal of sludge and the utilization of 

sludge for various purposes. 

§liS( a) Lake Tahoe Coordinate with Secretary of Agriculture and other Federal agencies 

Study regarding adequacy and need for extending Federal oversight of Lake 

Tahoe 

§311 (d)(2)(M) Oil and Consultation with FWS and NOAA for a fish and wildlife response plan 

Hazardous 

Substance 

Liability 

§312(e) Marine "Before the standards and regulations under this section are promulgated, 

Sanitation the Administrator and the Secretary of the department in which the Coast 

Devices Guard is operating shall consult with the Secretary of State; the Secretary 

ofllealth, Education. and Welfare; the Secretary of Defense; the Secretary 

of the Treasury; the Secretary of Commerce; other interested Federal 

agencies .. , 

Consu tatton ProvtsJOns 111 e era Insecttct e, Fungtct e, an . F d . "d . "d d d . Ro enttct "d e Act 

Section Section Title Text 

136w(a)(2)(A) Authority of the (A) Proposed Regulations: 

Administrator: Procedure: 

Proposed regulations At least 60 days prior to signing any proposed regulation 

for publication in the Federal Register, the Administrator 

shall provide the Secretary of Agriculture with a copy of 

such regulation. If the Secretary comments in writino to 

184 
264 


33371.246

the Administrator regarding any such regulation within 30 

days after receiving it, the Administrator shall publish in the 

Federal Register (with the proposed regulation) the 

comments of the Secretary and the response of 

the Administrator with regard to the Secretary's comments. 

Ifthe Secretary does not comment in writing to 

the Administrator regarding the regulation within 30 days 

after receiving it, the Administrator may sign such regulation 

for publication in the Federal Register any time after such 

30-day period notwithstanding the foregoing 60-day time 

requirement. 

I 36w(a)(2)(B) Authority of the At least 30 days prior to signing any regulation in final 

Administrator: Final form for publication in the Federal Register, 

Regulations the Administrator shall provide the Secretary of 

Agriculture witb a copy of such regulation, If the 

Secretary comments in writing to 

the Administrator regarding any such final regulation within 

I 5 days after receiving it, the Administrator shall publish in 

the Federal Register (with the final regulation) the comments 

of the Secretary, if requested by the Secretary, and the 

response of the Administrator concerning the Secretary's 

comments. lfthe Secretary does not comment in writing to 

the Administrator regarding the regulation within 15 days 

after receiving it, the Administrator may sign such regulation 

tor publication in the Federal Register at any time after such 

15-day period notwithstanding the foregoing 30-day time 

requirement. In taking any final action under this subsection, 

the Administrator shall include among those factors to be 

taken into account the effect of the regulation on production 

and prices of agricultural commodities, retail food prices, 

and otherwise on the agricultural economy, and 

the Administrator shall publish in the Federal Register an 

analysis of such effect 

136w(a)(3) Authority of the At such time as the Administrator is required under 

Administrator: Procedure: paragraph (2) of this subsection to provide the Secretary of 

Congressional Committees Agriculture with a copy of proposed regulations and a copy 

of the final form of regulations, the Administrator shall also 

furnish a copy of such regulations to the Committee on 

Agriculture of the House of Representatives and the 

Committee on Agriculture, Nutrition, and Forestry of the 

Senate. 

136w(a)(4) Authority of the Simultaneously with the promulgation of any rule or 

Administrator regulation under this subchapter, the Administrator shall 

transmit a copy thereof to the Secretary of the Senate and the 

Clerk of the House of Representatives. The rule or regulation 

shall not become effective until the passage of 60 calendar 

days after the rule or regulation is so transmitted. 

185 
265 


33371.247

136w-3 Identification of Pests; The Administrator. in coordination with the Secretary of 

cooperation with Agriculture, shall identity those pests that must be brought 

Department of Agriculture under control. The Administrator shall also coordinate and 

cooperate with the Secretary of Agriculture's research and 

implementation programs to develop and improve the safe 

use and effectiveness of chemical, biological. and altemative 

methods to combat and control pests that reduce the quality 

and economical production and distribution of agricultural 

products to domestic and foreign consumers. 

l36(r)(a) Research and Monitoring: The Administrator shall undertake research including 

Research research by grant or contract with other Federal agencies, 

universities, or others as may be necessary to carry out the 

purposes of this subchapter. and the Administrator shall 

conduct research into integrated pest management in 

coordination with the Secretary of Agriculture. The 

Administrator shall also take care to ensure that such 

research does not duplicate research being undertaken by any 

other Federal agency. 

136a-l (n)(2)-(3) Reregistration of (2) Consultation. In the case of a pesticide registered for use 

registered pesticides: in public health programs for vector control or for other uses 

Authorization of funds to the Administrator determines to be human health protection 

develop public health data uses, the Administrator shall, upon timely request by the 

registrant or any other interested person, or on the 

Administrator's own initiative may, consult with the 

Secretary [of Health and Human Services) prior to taking 

final action to suspend registration under section 

3(c)(2)(B)(iv) or cancel a registration under section 4. 6(e), 

or 6(1). In consultation with the Secretary, the Administrator 

shall prescribe the form and content of requests under this 

section. 

(3) Benefits to support family. The Administrator, 

after consulting with the Secretary, shall make a 

determination whether the potential benefits of continued use 

of the pesticide for public health or health protection 

purposes are of such significance as to warrant a 

commitment by the Secretary to conduct or to arrange for the 

conduct of the studies required by the Administrator to 

support continued registration under section or reregistration 

under section 4 

7 uses Definitions: Minor Use (2) the Administrator, in consultation with the Secretary of 

136(11)(2) Agriculture, determines that, based on information provided 

by an applicant for registration or a registrant, the use does 

not provide sufficient economic incentive to support the 

initial registration or continuing registration of a pesticide for I 

such use and-- I 

186 
266 


33371.248

l36i(a)(I) Use of restricted use Requires the Administrator to consult with Governor of each 

pesticides; applicators state to conduct a program for the certification of use of 

specific pesticides. 

!36a( c)( 1 )(F)(ii) Registration of Pesticides; The period of exclusive data use provided under clause (i) 

Procedure for registration shall be extended 1 additional year for each 3 minor uses 

registered after the date of enactment of this clause [enacted 

Aug. 3, 1996] and within 7 years of the commencement of 

the exclusive use period, up to a total of 3 additional years 

for all minor uses registered by the Administrator if the 

Administrator, in consultation with the Secretary of 

Agriculture, determines that, based on information provided 

by an applicant for registration or a registrant, that--(!) there 

are insufficient efficacious alternative registered pesticides 

available for the use; (!!)the alternatives to the minor use 

pesticide pose greater risks to the environment or human 

health; (Ill) the minor use pesticide plays or will play a 

significant part in managing pest resistance; or 

(IV) the minor use pesticide plays or will play a significant 

part in an integrated pest management program. 

l36t(b) Delegation and (b) Cooperation. The Administrator shall cooperate with the 

Cooperation Department of Agriculture, any other Federal agency, and 

any appropriate agency of any State or any political 

subdivision thereof, in carrying out the provisions of this Act 

and in securing uniformity of regulations. 

l36o(e) Imports and Exports Secretary of the Treasury shall prescribe regulations tor this 

section in consultation with the Administrator. 

l36p Exemption of Federal and The Administrator may, at the Administrator's discretion, 

State Agencies exempt any Federal or State agency from any provision of 

this Act if the Administrator determines that emergency 

conditions exist which require such exemption. The 

Administrator, in determining whether or not such 

emergency conditions exist, shall consult with the Secretary 

of Agriculture and the Governor of any State concerned if 

they request such determination. 

136w-7 Department of Agriculture (A) Grant authority. The Secretary, in consultation with the 

Minor Use Program Administrator. shall establish a program to make grants for 

the development of data to support minor use pesticide 

registrations and reregistrations. The amount of any such 

grant shall not exceed 1/2 of the cost of the project for which 

the grant is made. 

l36i-l(a)(l) Pesticide Recordkeeping The Secretary of Agriculture, in consultation with the 

Administrator of the Environmental Protection Agency, shall 

require certified applicators of restricted use pesticides 

136i-2(c) Collection of Pesticide Coordination. The Secretary of Agriculture shall, as 

Use Information appropriate, coordinate with the Administrator of the 

Environmental Protection Agency in the design of the 

187 
267 


33371.249

surveys and make available to the Administrator the 

a re ate results of the surve s to assist the Administrator. 

Consultation provisions under the Toxic Substances Control Act 

Section Title Text 

2609(a) Research, Development, (a) Authority. The Administrator shall, in consultation 

collection, dissemination, and cooperation with the Secretary of Health and Human 

and utilization of data Services and with other heads of appropriate 

departments and agencies, conduct such research, 

development, and monitoring as is necessary to carry out 

the purposes of this Act. The Administrator may enter into 

contracts and may make grants for research, development, 

and monitoring under this subsection. Contracts may be 

entered into under this subsection without regard to sections 

3648 and 3709 of the Revised Statutes 

2609(b)(l), (2) Research, development, Administrator shall Consult and cooperate with Secretary of 

collection. dissemination, HHS and other heads of appropriate departments and 

and utilization of agencies, to establish an efficient system for retrieval of 

information: Information toxicological and other scientitic information which could be 

Systems useful 

2609(c) Research, development, Administrator shall coordinate with Assistant Secretary for 

collection, dissemination, HHS to develop screening techniques 

and utilization of 

infonnation: Screening 

Techniques 

2609(d) Research, development. Administrator shall, in consultation and cooperation with the 

collection, dissemination, Secretary of Health and Human Services, establish and be 

and utilization of responsible for research aimed at the development, in 

infonnation: Monitoring cooperation with local, State, and Federal agencies, of 

monitoring techniques and instruments which may be used in 

the detection of toxic chemical substances and mixtures and 

whieh are reliable. economical, and capable of being 

implemented under a wide variety of conditions 

2609(c) Research, development, The Administrator shall, in consultation and cooperation with 

collection, dissemination, the Secretary of Health and Human Services, establish 

and utilization of research programs to develop the fundamental scientific 

information: Basic Research basis of the screening and monitoring techniques described in 

subsections (c) and (d), the bounds of the reliability of such 

techniques, and the opportunities for their improvement. 

2609(g) Research, development, The Administrator shall, in consultation with the Secretary of 

collection, dissemination, Health and Human Services and other heads of appropriate 

and utilization of departments and agencies, establish and coordinate a system 

information: Exchange of for exchange among Federal. State, and local authorities of 

research and development research and development results respecting toxic chemical 

results substances and mixtures, including a system to facilitate and 

promote the development of standard information format and 

analysis and consistent testing procedures. 

188 
268 


33371.250

2608(d) Coordination "Coordination. In administering this Act [15 USCS §§ 2601 

et seq.], the Administrator shall consult and coordinate with 

the Secretary of Health and Human Services and the heads of 

any other appropriate Federal executive department or 

agency, any relevant independent regulatory agency, and any 

other appropriate instrumentality of the Federal Government 

for the purpose of achieving the maximum enforcement of 

this Act ... " 

2608(e) Exposure Information If the Administrator obtains information related to exposures 

or releases of a chemical substance or mixture that may be 

prevented or reduced under another Federal law, including a 

law not administered by the Administrator, the Administrator 

shall make such information available to the relevant Federal 

agency or office of the Environmental Protection Agencv. 

12604(1)(5) Manufacturing and Consult with Assistant Secretary of Labor prior to adopting 

Processing Notices: any restriction of chemical substance for workplace 

Protection Against exposures 

Unreasonable Risks 

2604(h)(2)(B)(ii) Manufacturing and Consult with AG of the Federal Trade Commission about 

Processing Notices: exempting persons from information requirements. 

Exemptions 

c onsu tat10n p fOVISIOnS Ill t e h S a e ~ D. rm·mg k' W ater Act 

Section Title Text 

300g-l Standards: The Administrator may promulgate an interim national primary drinking 

(b)(l)(D) Listing of water regulation for a contaminant without making a determination for the 

Contaminants contaminant under paragraph ( 4)(C), or completing the analysis under 

for paragraph (3)(C), to address an urgent threat to public health as determined 

Consideration, by the Administrator after consultation with and written response to any 

Urgent Threats comments provided by the Secretary of Health and Human Services, 

to Public Health acting through the director of the Centers for Disease Control and 

Prevention or the director of the National Institutes of Health. 

300g-1(d) Regulations: Regulations; public hearings; administrative consultations. Regulations 

under this section shall be prescribed in accordance with section 553 of 

title 5, United States Code (relating to rule-making), except that the 

Administrator shall provide opportunity for public hearing prior to 

promulgation of such regulations. In proposing and promulgating 

regulations under this section, the Administrator sha11 consult with the 

Secretary and the National Drinking Water Advisory Council. 

300j-12(i)(2) Funds: Indian (2) Use of funds. Funds reserved pursuant to paragraph(!) shall be used 

Tribes: Use of to address the most significant threats to public health associated with 

Funds public water systems that serve Indian Tribes, as determined by the 

Administrator in consultation with the Director of the Indian Health 

Service and Indian Tribes. 

300j-13(a)(5) Source Water Demonstration project. The Administrator shall, as soon as practicable, 

Quality conduct a demonstration project. in consultation with other Federal 

Assessment agencies, to demonstrate the most effective and protective means of 

189 
269 


33371.251

assessing and protecting source waters serving large metropolitan areas 

and located on Federal lands. 

300j-5(b) National (b) Functions. The Council shall advise, consult with, and make 

Drinking Water recommendations to, the Administrator on matters relating to activities, 

Advisory functions, and policies of the Agency under this !i)le [42 USCS §§ 300f et 

Council seq.]. 

300j-3d Water Supply (a) Drinking water technology clearinghouse. The Administrator. 

Cost Savings in consultation with the Secretary of Agriculture, shall-

(I) develop a technology clearinghouse for information on the costeffectiveness of innovative and alternative drinking water delivery 

systems, including wells and well systems; and 

(2) disseminate such infonnation to the public and to communities and 

not-for-profit organizations seeking Federal funding for drinking water 

delivery systems serving 500 or fewer persons. 

300i-3(a) Contaminant In general. The Administrator, in consultation with the Centers for Disease 

Prevention, Control and, after consultation with appropriate depat1ments and agencies 

Detection and of the Federal Government and with State and local governments, shall 

Response review (or enter into contracts or cooperative agreements to provide for a 

review ot) current and future methods to prevent, detect and respond to the 

intentional introduction of chemical. biological or radiological 

contaminants into community water systems and source water for 

community water systems, including each of the following: 

300j- Algal Toxin (b) Information coordination. In carrying out this section the 

19(b)(2)(A) Risk Administrator shall--

Assessment and (2) as appropriate, consult with--

Management . (A) other Federal agencies that--

0 (i) examine or analyze cyanobacteria or algal toxins; or 

0 (ii) address public health concerns related to harmful 

algal blooms; 

Consultation Provisions in the Comprehensive Environmental Response. Compensation, and 

L' Ia bT I tty A ct 

Section Section Title Consultation Requirement 

§311 (a)( I) Research, The Secretary of Health and Human Services ... in consultation with the 

Development, Administrator, shall establish and support a basic research and training 

and program ... consisting of the following 

Demonstration (A) Basic research (including epidemiologic and ecologic studies) which 

may include each of the following: 

(i) Advanced techniques for the detection, assessment, and evaluation of 

the effects on human health of hazardous substances. 

I (ii) Methods to assess the risks to human health presented by hazardous 

substances. 

(iii) Methods and technologies to detect hazardous substances in the 

environment and basic biological, chemical. and physical methods to 

reduce the amount and toxicity of hazardous substances. 

(B) Training, which may include each ofthe following: 

190 
270 


33371.252

(i) Short courses and continuing education for State and local health and 

environment agency personnel and other personnel engaged in the 

handling of hazardous substances, in the management of facilities at 

which hazardous substances are located, and in the evaluation of the 

hazards to human health presented by such facilities. 

(ii) Graduate or advanced training in environmental and occupational 

health and safety and in the public health and engineering aspects of 

hazardous waste control. 

(iii) Graduate training in the geosciences, including hydrogeology, 

geological engineering. geophysics. geochemistry, and related fields 

necessary to meet professional personnel needs in the public and private 

(a) sectors and to effectuate the purposes of this Act. 

~3 I l(a)(2) Research, The Director of the Nationallnstitute for Environmental Health Sciences 

Development, shall cooperate fully with the relevant Federal agencies referred to in 

and subparagraph (A) of paragraph (5) in carrying out the purposes of this 

Demonstration section. 

§311(a)(5) Research, To assist in the implementation of this subsection and to aid in the 

Development, coordination of research and demonstration and training activities funded 

and from the Fund under this section, the Secretary shall appoint an advisory 

Demonstration council (hereinafter in this subsection referred to as the "Advisory 

Council") which shall consist of representatives oft he following: 

(A) The relevant Federal agencies. 

(13) The chemical industry. 

(C) The toxic waste management industry. 

(D) Institutions of higher education. 

(E) State and local health and environmental agencies. 

(F) The general public. 

§3 I l(a)(6) Research. Within nine months after the date of the enactment of this subsection, the 

Development, Secretary, acting through the Director of the National Institute for 

and Environmcntalllealth Sciences, shall issue a plan for the implementation 

Demonstration of paragraph (I). The plan shall include priorities for actions under 

paragraph (I) and include research and training relevant to scientific and 

technological issues resulting from site specific hazardous substance 

response experience. The Secretary shall, to the maximum extent 

practicable, take appropriate steps to coordinate program activities under 

this plan with the activities of other Federal agencies in order to avoid 

duplication of effort. The plan shaiJ be consistent with the need for the 

development of new technologies for meeting the goals of response 

actions in accordance with the provisions ofthis Act. The Advisory 

Council shall be provided an opportunity to review and comment on the 

plan and priorities and assist appropriate coordination among the relevant 

Federal agencies referred to in subparaoraph (A) of paragraph (5). 

§3 I I (c) Research, HAZARDOUS SUBSTANCE RESEARCH.-The Administrator may 

Development, conduct and support. through grants, cooperative agreements, and 

and contracts, research with respect to the detection, assessment, and 

Demonstration evaluation of the effects on and risks to human health of hazardous 

substances and detection of hazardous substances in the environment. 

The Administrator shall coordinate such research with the Secretary of 

Health and Human Services, acting through the advisory council 

established under this section, in order to avoid duplication of effort. 

I9l 
271 


33371.253

§ 104(i)(4) Response The Administrator of the ATSDR shall provide consultations upon 

Authorities request on health issues relating to exposure to hazardous or toxic 

substances, on the basis of available information, to the Administrator of 

EPA 

§104(i)(5)(A) Response For each hazardous substance listed pursuant to paragraph (2), the 

Authorities Administrator of ATSDR (in consultation with the Administrator of EPA 

and other agencies and programs of the Public Health Service) shall 

assess whether adequate information on the health effects of such 

substance is available. For any such substance for which adequate 

information is not available (or under development), the Administrator of 

ATSDR, in cooperation with the Director of the National Toxicology 

Program, shall assure the initiation of a program of research designed to 

determine the health effects (and techniques for development of methods 

to determine such health effects) of such substance. 

§ J 04(i)(6)(C) Response In determining the priority in which to conduct health assessments under 

Authorities this subsection, the Administrator of ATSDR, in consultation with the 

Administrator of EPA, shall give priority to those facilities at which there 

is documented evidence of the release of hazardous substances, at which 

the potential risk to human health appears highest, and for which in the 

judgment of the Administrator of A TSDR existing health assessment data 

are inadequate to assess the potential risk to human health as provided 

in subparagraph (F). In determining the priorities tor conducting health 

assessments 

§107(c) Abatement Within one hundred and eighty days after enactment of this Act, the 

Action Administrator of the Environmental Protection Agency shall, after 

consultation with the Attorney General, establish and publish guidelines 

for using the imminent hazard, enforcement. and emergency response 

authorities of this section and other existing statutes administered by the 

Administrator of the Environmental Protection Agency to effectuate the 

responsibilities and powers created bv this Act. 

§120(e)(l) Federal Not later than 6 months after the inclusion of any facility on the National 

Facilities Priorities List, the department, agency. or instrumentality which owns or 

operates such facility shall, in consultation with the Administrator and 

appropriate State authorities, commence a remedial investigation and 

feasibility study for such facility. 

§120(e)(6) Federal Administrator, after consultation with other departments, may determine 

Facilities that remedial efforts should be done by another potentially responsible 

party and may enter into a settlement agreement with such party. 

Consultation Provisions in the Resource Conservation and Recovery Act 

Section Section Title Consultation Requirement 

§2002(a)(1) Authorities of In carrying out this Act, the Administrator is authorized toAdministrator ( l) prescribe, in consultation with Federal, State, and regional authorities, 

'uch rePulations as are necessary to carry out his functions under this Act; 

§ lOOS(a) Solid Waste Administrator shall consult with Federal agencies, among others. to 

Management develop and publish guidelines for solid waste management. 

Information and 

Guidelines 

192 
272 


33371.254

§2001 Office of Solid Establishing an Interagency Coordinating Committee for RCRA between 

Waste and EPA. Department of Energy, Department of Commerce, and all other 

Interagency Federal agencies. Includes coordinating research and projects. 

Coordinating 

Committee 

§2002(a)(2)- Authorities of (2) consult with or exchange information with other Federal agencies 

(6) Administrator undertaking research, development, demonstration projects, studies, or 

investigations relating to solid waste; 

... 

(5) utilize the information, facilities, personnel and other resources of 

Federal agencies, including the National Bureau of Standards I and the 

National Bureau of the Census, on a reimbursable basis, to perform 

research and analyses and conduct studies and investigations related to 

resource recovery and conservation and to otherwise carry out the 

Administrator's functions under this Act; and 

(6) to delegate to the Secretary of Transportation the performance of any 

inspection or enforcement function under this Act relating to the 

transportation of hazardous waste where such delegation would avoid 

unnecessary duplication of activity and would carry out the objectives of 

this Act and of the Ha?.ardous Materials Transportation Act. 

§4002(b) Federal Not later than 18 months after enactment, Administrator shall consult 

Guidelines for with appropriate agencies to promulgate guidelines for the development 

Plans and implementation of State plans. Such guidelines should be reviewed 

and revised at least every three years. 

§SOOI(a) Research, The Administrator, alone or after consultation with the [Department of 

Demonstrations, Energy], or [FER C), shall conduct, and encourage, cooperate with, and 

Training, and render financial and other assistance to appropriate public (whether 

Other Activities Federal, State, interstate, or local) authorities, agencies, and institutions, 

private agencies and institutions, and individuals in the conduct of. and 

promote the coordination of, research, investigations, experiments, 

training, demonstrations, surveys, public education programs, and studies 

relating to-

(I) any adverse health and welfare effects of the release into the 

environment of material present in solid waste, and methods to eliminate 

such effects .... 

§8001(b)(2)( Research. any activities undertaken under provisions of sections 8002 and 8003 as 

D) Demonstrations, related to energy; as related to energy or synthetic fuels recovery from 

Training, and waste; or as related to energy conservation shall be accomplished through 

Other Activities coordination and consultation with the [Department of Energy l 

193 
273 


33371.255

NRDC's statement on EPA's Proposed Rule to Strengthen Science 

Transparency in EPA Regulations: 

Introduction 

Thank you for providing the Natural Resources Defense Council, Inc. (NRDC) this 

opportunity to present our views on "EPA's proposed rule to strengthen science 

transparency in EPA regulation." NRDC is a national, non-profit organization of 

scientists, lawyers, and environmental specialists, dedicated to protecting public 

health and the environment. Founded in 1970, NRDC serves more than two million 

members, supporters and environmental activists with offices in New York, 

Washington, DC, Los Angeles, San Francisco, Chicago, Bozeman, Montana, and 

Beijing. NRDC has been engaged with the environmental issues surrounding 

nuclear energy and nuclear weapons since our founding, and NRDC maintains a 

Nuclear Program staffed by a nuclear physicist, a nuclear engineer, a radiation 

health physicist and an attorney. 

EPA's proposed rule 

Despite the failure of the proposed rule to precisely name radiation standards or 

cite the EPA's authority under the Atomic Energy Act, with the agency's focus on 

reviewing the underlying science for dose-response models, it is NRDC's 

presumption that EPA intends to revise the underlying science for radiation 

standards, and the Linear No-threshold dose-response model (LNT) in particular. 

Specifically, EPA's proposed rule states that" ... this proposed regulation is 

designed to increase transparency of the assumptions underlying dose-response 

models. As a case in point, there is growing empirical evidence of non-linearity in 

the concentration response function for specific pollutants and health effects." The 

proposed rule fails to provide a citation or empirical evidence to support the 

statement. By contrast, the science in radiation epidemiological studies has 

repeatedly demonstrated, over decades, that the LNT dose-response model 

provides the most reasonable description of the relation between low dose 

exposure to ionizing radiation and the incidence of solid cancers that are induced 

by ionizing radiation. 
274 


33371.256

The Linear No-Threshold (LNT) dose-response model 

As it does in every other instance and under every other environmental statute, 

EPA relies on independent, authoritative scientific bodies to provide analyses and 

evaluations of scientific evidence in support of its radiation standard-setting 

policies. EPA bases its regulatory limits, and nonregulatory guidelines for 

population exposures to low-level ionizing radiation on the linear no-threshold 

(LNT) dose-response model. 1 EPA's radiation protection standards are based on 

the premise that any radiation dose carries some risk, and that risk increases 

directly with dose. This method of estimating risk is called the "linear no-threshold 

dose-response model (LNT). 

This longstanding and well-supported assumption assumes that the risk of cancer 

due to a low dose exposure is proportional to dose, with no threshold. For over 40 

years the LNT dose-response model has been commonly utilized when developing 

practical and prudent guidance on ways to protect workers and members of the 

public from the potential for harmful effects from radiation in balance with the 

commercially justified and optimized uses of radiation. EPA derives the LNT 

model from reports by authoritative scientific bodies including the U.S. National 

Academy of Sciences (NAS), the National Council on Radiation Protection and 

Measurements (NCRP), and the International Commission on Radiological 

Protection(ICRP). There is strong scientific consistency by these authoritative 

groups that an LNT model is the best at the current time (and has been for the past 

half century). 23 Indeed, EPA noted as recently as late 2015, ''[ o ]ver the last half 

century, numerous authoritative national and international bodies have convened 

committees of experts to examine the issue ofLNT as a tool for radiation 

regulation and risk assessment ... Again and again, these bodies have endorsed 

LNT as a reasonable approach to regulating exposures to low dose radiation." 4 

NAS Biological Effects oflonizing Radiation (BEIR) VII committee has studied 

and published its report on risk models for estimating the relationship between 

See, e.g., radiC~ti<)tl radiatitln·lwaith· c!Tc>:t:, 

Puskin, Jerome S. on the use of LNT for radiation protection and risk assessment by the US 

Environmental Protection Agency." Dose-Response 7.4 (2009): dose-response. 3 Valentin, Jack. The 2007 recommendations of the international commission on radiological protection. 

Oxford: Elsevier, 2007. d See 
275 


33371.257

exposure to low levels of ionizing radiation and harmful health effects. 5 The 

Committee judged that the LNT model provided the most reasonable description of 

the relation between low dose exposure to ionizing radiation and the incidence of 

solid cancers that are induced by ionizing radiation. 

The NCRP published its latest commentary on the LNT issue only weeks ago, in 

April 2018.6 The specific purpose of its commentary is to provide a review of 

recent epidemiologic data from studies with low doses or low dose rates and the 

Life Span Study (LSS) of atomic-bomb survivors to determine whether these 

epidemiologic studies broadly support the LNT dose-response model as a 

reasonable basis for radiation protection. Epidemiologic studies of humans provide 

evidence that is critically important in establishing potentially causal associations 

of environmental factors with the disease. The studies were selected by a 

consensus of experts who have a broad purview of the recent radiation 

epidemiology literature, and they ensured that the largest and most important 

eligible studies were included. 

NCRP commentary in conclusion of its epidemiology studies states that," ... based 

on current epidemiologic data, the LNT model should continue to be used for 

radiation protection purposes, and no alternative dose-response relationship 

appears more pragmatic or prudent for radiation protection purposes than the LNT 

model." 

How the proposed rule jeopardizes health protections 

The epidemiologic science and associated studies that are the basis of adherence to 

the LNT and decades of protective radiation standards are likely to be expressly 

excluded from consideration by EPA by the tenus ofthis proposed rule. 

NAS and other studies that EPA has long relied upon in the radiation standards 

setting process are epidemiological human cohort studies. EPA's proposed rule, if 

implemented, would limit EPA staff from basing regulatory actions on precisely 

these types of studies by requiring that the underlying data of these studies should 

Natiomd Research CounciL ffea!th risksj!·om exposure to low levt.!lv q('ioni:zinf{ radiathm: Rf~!R V!f phose 

2. Vol. 7. National Acudemics Press. 2006. 

NCRP Commentary 27. "Implications of Recent Epidemiologic Studies for the Linear-Nonthreshold Model 

and Radiation Protection." NCRP, 2018 
276 


33371.258

fully be publicly shared. This would be a nearly impossible task for the agency. 

Data for some of the radiation epidemiological studies are accessible to users7

·

8 

with a detailed description of how a user can access the information. However, 

public sharing of personally identifiable information (PII) is restricted because the 

studies rely on confidential health data. 

These are profoundly important studies that have been peer reviewed for decades 

and the science that has emerged from them has been validated multiple times. But 

these are not studies where the entirety of the public data can be shared or 

independently replicated. There are no other radiation epidemiologic studies of 

health and longevity on a large size population (example: more than 120,000 

individuals in the atomic-bomb survivor studies) that have continued for more than 

60 years. Thus, replication of the studies is impossible as this data comes from 

individuals exposed to significant acute and protracted dose of radiation. 

Implementation of the rule would effectively block the use of such key scientific 

studies and allow for radiation standards to be either wholly weakened or made 

functionally meaningless. 

Adverse consequences 

The U.S. EPA relied on the LNT dose-response model to develop the following 

reports and regulations to protect the general public and radiation workers from the 

potential for harmful effects from radiation: 

Federal guidance reports (FGRs) for radiation protection that provide technical 

information and policy recommendations for radiation dose and risk assessment: 

Nuclear fuel cycle standards and regulations addressing environmental issues 

for all phases of the uranium fuel cycle, including uranium milling; chemical 

conversion; fuel fabrication and reprocessing; power plant operations; waste 

management, storage, and disposal; and site cleanup for milling operations. 

Examples of areas that might be impacted by this rule include: 

I. Maximum allowed concentrations of radionuclides in drinking water 
277 


33371.259

2. Soil cleanup levels for Superfund sites 

3. Monitoring around radiation-producing equipment used for medical 

purposes 

4. Radioactive waste disposal 

5. The concept of ALARA (As Low As Reasonably Achievable) in radiation 

protection 

Conclusion 

Abandoning the LNT dose-response model and replacing it with either a threshold 

model or a concept that low doses of radiation are safe will have an adverse effect 

on radiation workers and the general public by allowing radiation protection 

regulations to be relaxed, reinterpreted and then weakened. In conclusion, I urge 

the EPA to abandon the proposed rule. Thank you! 
278 


33371.260

• ECOL04iiCAL SOCIETY OF AMERICA. 

esa Ecological Society of America 

1990 M St, NW, Suite 700 

Washington, DC 20036 

October I, 2018 

The Honorable John Barrasso 

Chairman 

Committee on Environment and Public Works 

410 Dirksen Senate Office Building 

Washington, DC 20510 

The Honorable Mike Rounds 

Chairman 

Subcommittee on Waste Management 

and Regulatory Oversight 

410 Dirksen Senate Office Building 

Washington, DC 20510 

The Honorable Thomas R. Carper 

Ranking Member 

Committee on Environment and Public Works 

456 Dirksen Senate Office Building 

Washington, DC 20510 

The Honorable Cory Booker 

Ranking Member 

Subcommittee on Waste Management 

and Regulatory Oversight 

456 Dirksen Senate Office Building 

Washington, DC 20510 

Re: Oversight of the Environmental Protection Agency's Implementation of Sound and Transparent Science in Regulation 

Dear Senators Barrasso, Rounds, Carper, and Booker: 

The Ecological Society of America (ESA) is a professional scientific society composed of over 9,000 professional 

ecologists. I write on its behalf to express ESA's strong opposition to the Environmental Protection Agency's Notice of 

Proposed Rulemaking, ''Strengthening Transparency in Regulatory Science." 

The proposed rule stipulates that the U.S. Environmental Protection Agency (EPA) will ensure that the data and models 

underlying the pivotal science that informs significant regulatory actions are made publicly available and that they are 

available in a format that allows for outside analysis and validation. Within the scientific community, high~quality 

scientific studies are judged by scientific methodology and the rigor with which they are conducted during the peer review 

process. and not solely on data transparency. While the ESA generally supports open science and transparency, the ESA is 

concerned that overly stringent requirements for transparency may cause valid scientific evidence to be discarded and 

thereby pose a threat to the credibility of regulatory science and the EPA's ability to use the best available science in 

decision-making. As a result, the proposed rule could have far-reaching consequences for clean air, clean water, public 

health and the environment The proposed rule also ignores the inherent risks involved in data disclosure such as the need 

to protect confidential human subject data used in epidemiologic studies. 

The proposed rule will not improve the quality of science used by the EPA or allow the agency to fulfill its mandate of 

protecting human health and the environment The ESA strongly opposes the EPA's efforts to restrict the use of the best 

available science in its policymaking. The Society stands ready to work with Members of Congress, the EPA and other 

members of the scientific community to evaluate the unintended consequences of this proposed mle. Thank you for 

providing oversight on this issue and for your consideration of our concerns. 

Sincerely, 

Laura Hucnneke, Ph.D 

President 

Phoneo (202) 833-8773 • Faxo (202) 833-8775 • Email; esahq@esa.org • Webo http//www.esa.org/ 
279 

Senator ROUNDS. I would ask unanimous consent to include in 

the record several articles written by Dr. Calabrese and a letter in 

support of the proposed science transparency rule from the American Chemistry. 

Senator BOOKER. He has published 900 articles. Are you putting 

them all in the record? 

Senator ROUNDS. Five hundred. 

Senator BOOKER. Just no requirement that I read them, please. 

Senator ROUNDS. Not today, anyway. 

Senator BOOKER. Not today. OK. 

[The referenced information follows:] 

280 


33371.261

/\cad. Quest. 

DOt t 0.1 007/> 1212 9-0 t 7-9660-6 

(I) CrossMark 

UNSETTLED SCIENCE 

Societal Threats from Ideologically Driven Science 

Edward J. Calabrese 

Springer Science+Busincss Media, LLC 2017 

I remember clearly my first week in graduate school in the entomology 

department at the University of Massachusetts Amherst in 1971. One of my 

fellow graduate students had just reported on a potentially important finding 

relating to a type of circadian rhythm, the twenty-four-hour cycle of biological 

processes that many organisms exhibit. The key observation occmred between 

1 :00 a.m. and 4:00a.m. He was going to confirm his findings the following day. 

For reasons that were not shared, my advisor had some doubts about this 

"major" discovery and decided to be present at the lab between I :00 a.m. and 

4:00 a.m., along with the department chair (in retrospect, a bad sign). 

When the student arrived at the lab the next day, my advisor asked whether 

the significant findings had been confirmed. The student acted very excited, 

claiming to have confirmed the result, and showed the data. The only problem 

was that during those early morning hours the student had not been in the lab, 

where my advisor and chair sat waiting and waiting to see him. The novel 

discovery proved to be a hoax, and in less than an hour the student had cleared 

out his office and was never to be seen again. 

As for me, I got his office and an eye-opening education on honesty in 

science. life in general, and the consequences of unethical behavior. 

I have never been too preoccupied with issues of honesty over the years because 

everyone I have worked with has seemed to be tmthful about their science. Plus, we 

have tended to work in very close teams with multiple people checking what 

everyone else was doing. There have been many disagreements on all aspects of 

studies and data interpretation, but no challenges on the honesty issue. I have read 

William Broad and Nicholas Wade's 1982 book Betrayers o(the Truth, all about 

Edward .1. Calabrese is professor of toxicology in the Dcpmtmcnt of Environmental llcalth Sciences at the 

University of Ma:5sachusctts Amherst, Amher~t, MA 01002; edwardc@schoolph.umass.cdu. 

'!} Springer 

Published online: 30 October 2017 
281 


33371.262

Calabrese 

fraud and deceit in science, but its stories and scenes seem to belong to a 

different world from mine. Most ofthe individuals caught in fraud appear to 

be in a mad race for some type of academic glory, whereas my life in 

science has been far more quiet. sedate, and mostly fun. 

Muller and the History of Dose-Response 

The issue of honesty and deceit in science would reenter my life exactly 

forty years after my first week in graduate school. It all started very quietly. 

I had written a substantial review paper on the history of the linear doseresponse, how it came to be accepted and used by regulatory agencies. The 

dose-response refers to the means by which drugs and other chemicals and 

physical agents, like radiation. affect biological systems and how this may 

be influenced by both the total amount and the rate of agent administered. 

As has long been my custom, I often send a copy of the draft manuscript to 

a group of knowledgeable friendly critics prior to journal submission. On 

this occasion one of the friendly critics, a very experienced expert in the 

area of genotoxicology, wrote that I had not explained the role of the Nobel 

laureate Hermann .T. Muller and his significance in this area as deeply and 

insightfully as it probably needed to be covered. 

He did not claim to be an expert on Muller, who was awarded the 1946 Nobel 

Prize in Physiology or Medicine for his discovery of the production of mutations 

by means of X-ray irradiation, but simply had a strong hunch that I was missing 

an important part of the story. Based on my respect for this person's past insights 

and help, this was more than enough for me to put the paper on hold to learn all 

about Muller's life and accomplishments. I obtained numerous articles by 

Muller, multiple articles about him, a substantial biography, and his 

December 12, 1946. Nobel Lecture. I even found a 1957 lecture he gave 

to other Nobel winners posted on the web. It was interesting to hear his 

voice, see his mannerisms, and follow his train of thought. 

I stm1ed with Muller's earliest papers and followed his career until the very 

end. Then l read and studied his biography and Nobel Lecture. This method was 

expansive, since it also forced me to look at the lives of other leading scientists 

of his era who worked with him in one way or another in the area of radiation 

genetics. This study led me to the previously unexplored world of the history of 

science. especially the history of radiation, mutation. cancer, and public health. 

From reading multiple dissertations I came to appreciate the incredible depth 

and insight that such historians of science offer. and 1 was upset that J had never 

£}Springer 
282 


33371.263

Societal Threats from Ideologically Driven Science 

really taken the time to learn about and from these effiJrts. So much had J 

missed! It was a bit like peeling an onion. 

The story of Muller and his era became progressively more interesting and 

offered much insight into the scientific process. Little did my friendly critic 

know that his comment had reawakened in me a latent gene for the unrelenting 

search for historical truth. In fact, in my freshman year of college l had started 

out as a history major and then got so inspired by my zoology course that I 

switched to biology. Now it seemed that J was coming full circle. 

I became particularly fascinated with parts of Muller's life because he was a 

professor at Amherst College (1940-1945), located in the town where l live, 

something l did not know. I tracked down the house he lived in, which was just a 

short walk to the college and about 1.5 miles from my home. I learned much 

about his work on the Manhattan Project with the famous geneticists Curt Stem 

and Ernst Caspari, and its impact on dose-response. My c1itic was correct: 

Muller was very important in the history of dose-response and risk assessment. 

In fact, I learned that Muller created the term '"proportionality rule" in 1930 to 

describe the linear dose-response and played a key supportive role in the initial 

creation of the LNT single-hit model in the mid-1930s. The LNT dose-response 

model assumes that the response is directly proportional to dose down to a single 

molecule. In marked contrast. the threshold dose-response assumes that there is a 

safe level of exposure as long as the exposure is below the threshold dose. 

Manhattan Project and Dose-Response 

While doing this historical digging, I noticed a potential disparity 

between what Muller stated in his Nobel Lecture and what I had come 

to learn about key findings in the mutation study of Caspari and Stern, 

on which Muller was a paid consultant. In his Nobel Lecture, Muller 

was quite emphatic that the threshold dose-response model was not 

scientifically credible and needed to be replaced by the LNT model for 

risk assessment. l found this very curious, since in August 1946 Caspari 

finished his major study on the effects of chronic ionizing radiation on 

mutations in Drosophila and found a threshold response. 

The genetic damage component of the Manhattan Project was conducted at the 

University of Rochester under the direction of Stern. It represented the most 

significant research ever in this area. It had a very strong research team, improved 

quality control, large-scale studies, and excellent teclmical support, among other 

factors. While Stem, Muller, Caspari, and the rest of the Rochester team 

.g). Springer 
283 


33371.264

Calabrese 

were expecting that Caspari would confinn their belief in linearity, he didn't. In 

fact, just the opposite happened. His data demonstrated a threshold dose-response. 

This was the proverbial fly in the ointment. Had Caspari's data supported a 

linear dose-response, it would have provided a major boost for the goal of 

replacing the threshold model with LNT held by Muller, Stern, and most others 

in the radiation genetics community. 

This made me wonder whether Muller had seen the Caspari findings prior to 

giving the Nobel Lecture. I figured that he probably had not seen them since he 

never could otherwise have made the statement that he did about the lack of 

possibility of there being a threshold. Here was the best study to date, one in 

which Muller was an active and influential consultant and knew the quality of 

the people and research effmt. 

How could he ignore it, or worse still, dismiss it? 

I needed to find out what Muller knew and when he came to know it. I 

contacted some historians of science and they had no insights on this question, 

so I ended up purchasing all the communication I could identify between Muller 

and all the Stem team members. Late one afternoon I received between six 

hundred and eight hundred pages of con·espondence and related material. 

I reviewed all the material that evening and found the so-called smoking gun. 

I learned that Stem had sent Muller the manuscript that he and Caspari had 

prepared on the study on November 6, 1946, after having alerted Muller in 

September to expect it. Muller acknowledged receipt of the Caspari manusctipt 

and offered preliminary comments on it in a November 12, 1946, letter to Stem. 

In the letter Muller acknowledged that these tindings seriously challenged the 

LNT model. that the study needed to be replicated, that Stern needed to get the 

funds to do this, and that Caspari was a very competent researcher and that 

Muller could not dismiss the study due to inexpetience or other reasons. Thus I 

knew for the first time that Muller had seen the Caspari findings one month prior 

to giving his Nobel Lecture and had an excellent sense of its significant 

implications, and that it could not be dismissed but needed to be repeated. 

This new infonnation troubled me. I putmyselfin Muller's position: Ifl were about 

to receive the Nobel Prize, could I ever state that there was no possibility that the 

threshold model was biologically plausible after seeing the Caspari study findings? In 

tact, his recommendation tor a major replication directly contradicted this comment. 

The replication was not trivial and would take a year and require the help of multiple 

technicians. plus one as experienced as Cas pari or Stem to direct it. I felt that the best I 

could do on this matter, ifl were in Muller's situation, would be to acknowledge that 

the shape of the close-response in the low dose zone remained a viable research 

question and needed to be resolved. I might have stated that while I believe that the 

£!Springer 
284 


33371.265

Societal Threats fi·om Ideologically Driven Science 

linear dose-response is most likely the con·ect view. this needed to be assessed further. 

And yet, while Muller acted like a scientist in his communications with Stem, in his 

public demeanor he was deceitful and vety ideological---everything a scientist should 

not be. To act this way during the most significant moment in his professional life 

revealed important character traits in Muller, including those of dishonesty, risktaking, manipulation, and arrogance. 

I held out hope that he may have had new insights that led him to criticize the 

study and that would provide an explanation for his rejection of Caspari's 

threshold conclusion. However, a detailed seven-page letter to Stem dated 

January 14, I 947, reaftlrmed the November 12, 1946, letter. With this now in 

hand I came to the fim1 but unsettling conclusion that Muller was deliberately 

deceptive in his Nobel Lecture and used this opportunity to achieve a longdreamed-of goal to have LNT as the default model for cancer risk assessment. 

This was his chance and, apparently, the ends justified the means-again, a 

rationalization that scientists should never accept. 

In 2012, I published this Muller Nobel Lecture story in the toxicological 

literature. 1 It quickly generated a series of criticisms, mostly ad hominem attacks 

on my character and research achievements. These were in part related to the fact 

that Muller could not defend himself along with other earlier defenders of the 

LNT model. These critics may not have been aware that Muller had himself 

criticized the work of a deceased scientist, Lewis J. Stadler, who had 

challenged Muller's gene mutation interpretations from 1931 until his death 

in 1954 and likewise could not respond to Muller's criticisms in 1956. 

Dose-Response and Deception 

The deception issue would not end with Muller's Nobel Lecture, but would 

serve as the tip of even more troubling revelations. My initial follow-up wa~ to 

make a detailed evaluation of the Manhattan Project's genetics/radiation research 

and see what l could learn from it. With respect to the Caspari research, I learned 

that Stem at first refused to accept the validity of these findings, claiming that the 

only reason that Caspari observed a threshold was due to a control group that had 

aberrantly high mutation rates that led to the threshold rather tllan linearity. To his 

credit, Caspari dug into the literature and presented convincing evidence that the 

control group was not aberrant but normal. To his credit, Stern backed 

1 Edward J. Calabrese, "Muller's Nobel Prize Lecture: When Ideology Prevailed over Science," 7bxicological 

Sciences 126, no. 1 (2012): l 4; "Muller's Nobel Lecture on Dose-Response for Ionizing Radiation: Ideology 

or Science?" Archives of Toxicology 85. no. 12 (2011): 1495--98; and "Key Studies Used to Support Cancer 

Risk ;\ssessmcnt Questioned." f:'nvimnmc:utal and Molecular Muwgcncsis 52, no. 8 (20 [I): 595 606. 

'f) Springer 
285 


33371.266

Calabrese 

down---that is, the Caspari control was now considered normal. Did this mean 

that Stem gave up the effort to minimize the influence of the Cas pari findings? 

Not in the least --but how did he do this? 

It was subtle and it took both Stem and Caspari to do it, the latter oddly 

cooperating with etiorts to undermine his own study, perhaps due to his sensing 

of what was important to Stem, his influential supervisor. First, a detailed reading 

of the paper revealed that essentially the entire discussion centered on why their 

data should not be accepted until it could be learned why this study showed a 

threshold, while a companion acute study lead by Warren Spenser completed a 

year before showed a linear dose-response. In many ways this was a false 

argument, since the two studies had more than twenty-five methodological 

differences and the issue could never have been practically resolved. They had 

to know this. 

Second, the Caspari study was superior to the Spenser study in multiple ways: 

it was performed second, used better equipment and facilities, and improved 

temperature controls, among other features. ln addition, much was learned during 

the Spenser study that was transferable to Caspari's efforts. Further, a detailed 

review of the Spenser study revealed a long list of problems that Stem, Muller, 

and others apparently never detected. All of these issues have now been 

documented. and some are serious. 

The bottom line is that Stem and Muller did not want the Caspari paper to 

see the light of day, and if it did, they wanted to seriously compromise its 

impact. This view is actually reflected in Muller's January 14, 194 7, letter to 

Stem. 

The story gets even more intriguing as we now consider the attempt to 

replicate Caspari's findings. h1 fact, it gets much worse, as the historical record 

shows to what lengths Stem and Muller and others LU1der their int1uence, or spell, 

would go to twist the truth to advance their ideology. Sometimes this resulted in 

direct lies, other times in data manipulation, censming, and other fonns of 

obfuscation and misleading behavior. 

In the first replication study paper, for example, Stem and Delta Uphoff. a 

master's student at the University of Rochester, concluded that her control was 

aberrantly low and that this led to data that could not be properly interpreted. 

This was based on extensive written communication with Muller. Muller had a 

massive an1ount of control mutation data in studies dealing with the aforementioned 

dispute with Lewis Stadler on the nature of gene mutations. In multiple letters that I 

obtained, Muller unequivocally supported the Caspati control as nonnal and the 

Uphoff control as aberrant. This write-up was sent to the Atomic Energy 

Commission by Stern and was classified. When Stern published the 

©Springer 
286 


33371.267

Societal Threats !rom Ideologically Driven Science 

findings a year later, he and Uphoff neglected to inform the scientific 

community that one year earlier the data that they were now publishing 

had been uninterpretable (their own written characterization) and that her 

control group was aberrant based on the data in the published literature and 

in Muller's massive database. 

A second example involved Muller writing in the scientific literature that 

the study by Caspari that challenged LNT should not have credibility because 

of its aberrantly high control group values. Of course, he had the data to 

support the Cas pari findings and had done so in writing in a series of letters 

with Stem. Despite the duplicity of Muller on this issue, he was never 

challenged by Stern or Caspari---even though they knew that Muller had 

directly contradicted his letters to Stern and his publications. 

The National Academy of Sciences and LNT 

It would be bad enough if the story stopped here, but it didn't. It became even 

worse. The next noteworthy developments occurred when the National Academy 

of Sciences (NAS) created its Biological Effects of Atomic Radiation (BEAR) I 

Committee in 1955 and atmounced its seminal recommendation to switch to 

linearity in June 1956. This was actually the big ideological payotifor all the past 

etforts to ensure the success of the LNT. It represented collusion, I should say, 

inbreeding at the highest levels: the Rockefeller Foundation funded the BEAR 

committee; Detlev Bronk, president of the NAS, was also president of the 

Rockefeller Institute for Medical Sciences (later Rockefeller University); and 

Bronk chose the chaim1a11 ofthe Genetics Panel from the Rockefeller Foundation. 

Transcripts reveal that the chair was enticing the panelists with more 

Rockefeller grant money. The goal was to get the scientific community 

and the public to go linear, simple as that. For this to happen, data had to 

be censored. In addition. the Genetics Panel had to show that it was in 

close agreement on the scientific basis of radiation-induced mutation 

risks. which their individual estimates were designed to show. However, 

the panel was so split in their scientific conclusions of radiation-induced mutation 

risks that ifthey were shared with the public. the policy recommendations of the 

panel would have no credibility-or so the panel members. such as Jim Crow, a 

University of Wisconsin professor of genetics, strongly believed and wrote 

about in correspondence with Chairman Warren Weaver. 

%) Springer 
287 


33371.268

Calabrese 

My Conclusions and Their Consequences 

The findings to support my conclusions have been published in considerable detail? They reveal that the Genetics Ptmel misrepresented the research 

record in the journal Science on several key matters, all of which were needed 

to get their policy views accepted. The panel voted on these matters, including 

deciding not to show their data and not to provide any written justification for 

their conclusions. Thankfully, these highly prestigious scientists preserved their 

correspondence reports and notes, which pem1itted me to discover their 

deceptions-both as individuals and, more surprising, as an NAS 

committee-and eventually piece this story together. The 1956 NAS BEAR 

I Genetics Panel report and its LNT recommendations would become the most 

significant document in the seventy-year history of cancer risk assessment. 

The acceptance of their guidance is the historical basis of why the U.S. and 

numerous other countries adopted the LNT. As the twig is bent so grows the 

tree. 

Two years ago Jerry Cuttler, an active researcher on LNT and radiation, 

wrote to Marcia McNutt. editor-in-chief of Science, to request that the 1956 

mticle of the BEAR I Genetics Panel be retracted due to my documentation of 

its deliberate misrepresentation of the scientific record and the major and 

continuing historical significance of this paper.3 The situation was complicated 

from the start, since McNutt was also a finalist to become the next president 

of the NAS, and her name was already posted on the NAS website as such. 

In such a situation. McNutt should have recused herself from deciding on this 

issue. Since the then-outgoing NAS president Ralph J. Cicerone was strongly 

disputing my challenging papers at the time. McNutt's conflict of interest with 

deciding upon the retraction request and her desire to become the next NAS 

president is obvious. Yet despite her finalist status-m1d she did become NAS 

president-McNutt did not recuse herself. Her decision was to deny the request. 

(The appendix to this article contains three key e-mail exchanges on this issue.) It 

was also disturbing that no apparent set of checks and balances existed within 

Science's organization to ensure proper oversight on such matters. 

The story of LNT, therefore, is one of leading scientists, from the time of 

Muller's Nobel Lecture in 1946 to today. being driven by ideology and/or 

self-interest. This should not be who we arc as scientists, nor what we should accept. 

2Edward J. Calabrese. "On the Origins of the Linear No-Threshold (LNT) Dogma by Means of untruths, Artful 

Dodges and Blind Faith," Em·imnmemal Research 142 (2015): 432-·42. 

3Edward J. Calabrese. "LNTgatc: llow Scicntil!c Misconduct by tho U.S. NAS Led to Government' Adopting 

LNT lor Cancer Risk Assessment," Environm~ntal Rescan:h 14R (20 16): 535 46. 

'©Springer 
288 


33371.269

Societal Threats from Ideologically Driven Science 

APPENDIX 

Marcia McNutt, e-mail message to Jerry Cuttler, August 11, 2015 

Subject: Science Paper, Genetic Effects of Atomic Radiation; Evidence of Scientific 

Misconduct 

Dear Dr. Cuttler: 

We considered carefully your concerns about the controversy with respect to the 

linear no-threshold (LNT) dose-response model for assessing the risk of radiationinduced cancer. You have requested that Science retract a 1956 paper that takes a 

position on this issue. Standard practice in Science and other journals would be not to 

consider the retraction of an article more than just a few years old except in 

extraordinary circumstances. New discoveries are constantly advancing the 

frontiers of science, and unless we had some statute of limitations on 

retractions, we would be constantly retracting old articles after the field 

has moved on. We can imagine certain exceptions in cases of papers that 

arc still highly int1uential. In considering this specific request to Science, 

we asked the following questions: 

(i) Is the 1956 Science paper trustworthy? We concluded that we cannot produce 

the information we need to answer this question 60 years post publication to 

the standards that would be required to consider a formal retraction. The 

authors are no longer living. We do not even have a record ofthe Science 

editorial standards of that em, much less a review jacket for that paper. This 

case is so old we would never be able to reconstruct the evidence from all 

parties involved in our editorial decision. 

(ii) lfthe paper is not trustworthy, is the matter a problem of scientific quality or 

scientific integrity? Because we cannot answer (i), we cannot answer (ii). 

However, 1 will note that many of the concerns raised in the Calabrese paper 

would fall under the classification of science quality, not science integrity. 

They would not be grounds for retraction of a paper 60 years after the fact. 

(iii) Does this Science paper still have the "pervasive int1uence" claimed in the 

article by Calabrese? We consulted an independent expe1t whose positions 

indicate that s/he has no extreme positions on this matter. one way or another. 

His/her considered view is thatthe I 956 Science paper was one ofhundreds of 

papers over the past half century on this broad topic, and certainly the use of 

the LNT model by almost all the regulatory agencies, world wide, is now 

based on a lot more than the NRC report and Dr. Muller's work. For example, 

~Springer 
289 


33371.270

Calabrese 

if you take a look at the series ofNRC "BEIR" [Biological Effects oflonizing 

Radiation] 4 reports, in the more recent ones there is no particu Jar emphasis on 

Muller's work, with the arguments now more based on endpoints that more 

directly relate to radiation-induced cancer. 

Based on this analysis, we do not sec any reason to consider revising our policy 

for this paper. Science considers this case closed and will not reconsider the 

decision. 

Dr. Marcia K. McNutt 

Editor-in-Chiet: Science family ofjoumals 

American Association for the Advancement of Science 

1200 New York Avenue N.W. 

Washington, D.C. 20005 

Edward A. Calabrese, e-mail message to Marcia McNutt, August 19,2015 

Subject: NAS 195611 aper Retraction 

Dear Dr. McNutt: 

I read your e-mail letter to Dr. Cuttler, rejecting his request (and others) to retract 

the NAS BEAR I, Committee Genetics Panel published in Science in June, 

1956, due to its multiple incidents ofsctious falsification and fabrication. I have 

carefully studied your five reasons for this decision. 

While 1 commend you tor your directness and transparency in sharing the basis of 

the decision, I have concluded that your analysis of the issue was faulty on each of 

the five reasons (see attached or below) and contradicted by the factual record in a 

number of cases. While I know you wrote that the decision was "final," I hope 

that you will be open to the new analysis and that you will reconsider this issue. 

Sincerely, 

Edward J. Calabrese, Ph.D. 

Department of Environmental Health Sciences 

School of Public Health and Health Sciences 

University of Massachusetts 

Amherst, MA 01 003 

·'see, for example, National Research Council of the National Academies. l!ealt!J Lf{ec(> o/Erposure to Low 

Levels<~( !oni::iiTg Radiation: BEJR \Ill Phase 2 (Washington, DC: The National Academics Press, 2006). 

Q Springer 
290 


33371.271

Societal Threats !rom Ideologically Driven Science 

Issue #1: Is the situation extraordinary given the 60 year time lag'! 

The situation is extraordinary because the LNT model for cancer risk 

assessment continues to dominate all regulatory agencies, affects clinical 

treatments, environmental regulations, clean-up costs, medical treatment strategies, 

all needlessly wasting massive resources. In fact, it is widely believed that the 

recommendations by the NAS BEAR I Committee, Genetics Panel to switch from 

threshold to the LNT model was the most significant event in the history of risk 

assessment. It is also extraordinary because substantial contemporary toxicological 

discoveries have revealed serious failings with the LNT model with findings more 

consistent with the threshold and hormesis models. 

Issue #2: New discoveries are constantly advancing the frontiers of science: 

Contrary to your statement, my letter did not challenge an older paper (i.e., NAS 

Genetics Panel Science paper, 1956) based on new discoveries such as DNA 

repair, adaptive responses, apoptosis, and hormesis that could create non-linear 

dose-responses. It is, however, challenging this paper because it falsified and 

fabricated the research record and it continues to affect, in significant ways, the 

beliefs and actions of regulatory agencies. influential governmental and nongovernmental organizations, educational institutions, materials and practices, 

and leaders in the risk assessment field---all without their knowledge that the 

Genetics Panel paper in Science is now recognized as being based on fraud and 

deception. 

Issue #3: Is the Science paper trustworthy? You claim that this is not 

knowable because: new standards for evaluation; because the authors are 

not alive; and the 1950s recordkeeping is poor and without knowledge of 

how this paper was reviewed. 

The issues of falsification and fabrication are historically founded and have 

long been addressed by professional standards in the sciences and their 

journals. My published articles have shown that the research record was 

deliberately altered in the Science paper by the Genetics Panel and I 

possess and cited the text of letters and memos documenting the scientific 

misconduct and the reasons why the falsification/fabrication was done. The 

fact that none of the Panel members are alive is adequately compensated by 

the factual record which is substantive and unequivocal, with high internal 

and external consistency. It is not significant to the present case whether 

the Genetics Panel paper in Science received a peer review, as most reports 

by high level advisory committees are usually stand-alone and not subject 

':f:i Springer 
291 


33371.272

Calabrese 

to standard peer-review processes, as are papers of individual scientists. 

Nonetheless, all papers need integrity and honest reporting. My published 

papers have shown that the BEAR I Genetics Panel failed in this regard in 

multiple and critical ways, affecting key conclusions and acceptance of 

their findings by the scientific community, governmental agencies, and the 

general public. 

Issue #4: Is the problem one of scientific quality or integrity? 

You do not provide any specific evidence, but offer a general statement that 

many examples cited in the Calabrese (20 15) paper concerned scientific 

quality rather than integrity. The fact that there were important issues raised 

about scientific quality (e.g., the obvious description of Jim Crow's research 

method) does not detract from the integrity issue. The key point is that it was 

because ofthe poor data quality that the Panel decided to cover up their 

scientific weaknesses (i.e., poor quality) so that their goal of a switch to LNT 

could occur. The central issue is that the Panel was not honest and altered the 

research record to promote this goal. I suspect that if the data quality were good, 

they would not have "needed" to lie and deceive. However, their LNT goal was 

more important than truth. 

Issue #5: The continuing "pervasive influence" ofthe 1956 paper: 

You cite an mmamed knowledgeable independent consultant who told you that 

the LNT is now based on many more papers than the NRC report and Muller's 

work. First, the Calabrese (20 15) paper never states that the LNT was based on 

Muller's research. It states that Muller used his influence to promote acceptance 

of the LNT by being dishonest in his spoken and written words, all of which 

were documented. The paper traced the initial acceptance of the LNT to the 

work of Curt Stem and his students and these were highly criticized in the 

Calabrese paper. It was the Stem papers that the BEAR I Genetics Panel based 

their beliefs upon and cited in subsequent Congressional testimony ( 1957). You 

stated that the more recent BEIR reports do not base their recommendations on 

Muller's work and focus now on cancer. In multiple papers l show that within one 

year of BEAR I, that major advisory groups had generalized the Genetics 

Panel recommendation from genetic risk to cancer risk assessment. We 

have also documented that the U.S. EPA in the late 1970s specifically relied on the 

BEAR Genetics Panel 1956 recommendation when it adopted LNT, showing 

clearly that your assertions are incotTect. More specifically, Roy Albert, Chair of 

the EPA Carcinogen Group, in his 1994 paper in Critical RevieY..'S in Toxicology, has 

reported that EPA adopted the L1'-.'T model of the Atomic Energy Commission (who 

1.} Springer 
292 


33371.273

Societal Thrcal< from Ideologically Driven Science 

adopted the BEAR I, Genetics Panel report) that had been applied to estimating risk 

tor fallout from atomic weapon tests. He stated that it was clear, simple, and easily 

understood and was plausible based on the linearity of the mutation response (see 

BEAR I) within the framework oftarget theory. He then noted that "any difference 

between chemical carcinogens and ionizing mdiation could be waved aside as 

both cause genetic damage." Thus, the BEAR I report in Science served as the 

critical foundation for the current EPA LNT cancer risk assessment. 

A vast number of published papers with experimental data contradict the 

LNT model. In fact, the mega-mouse (24,000 mice) study of the FDA to estimate 

the shape of the dose-response in the low dose zone showed a striking horrnetic 

dose-response for bladder cancer as emphasized by a 14-member expert panel of 

the Society of Toxicology. Detailed Japanese studies with DDT showed clear 

hormetic dose-responses for carcinogenicity. Numerous whole animal 

cancer bioassays with ionizing radiation show reduced cancer risks and 

life extension at low doses in multiple models. These and numerous other 

findings, along with the above conceptual developments (DNA repair, 

adaptive response, etc.) all happened after BEAR I. If anything, the LNT 

model decision should have been reversed except for the ideological grip 

that has long enveloped this field. 

In summary, this response addresses each issue that your letter used to support 

your rejection of the request to retract the NAS 1956 Science paper due to 

research misconduct. The evidence presented here provides an objective 

basis for you to reconsider the proposal to retract the 1956 NAS Genetics 

Panel Science paper. The evidence is convincing that misconduct did occur, 

and the issue is too important to continue to ignore. Science has a professional 

and moral responsibility to correct this continuing scientific deceit. 

Marcia McNutt, e-mail message to Edward A. Calabrese, August 19, 2015 

Subject: NAS 1956 Paper Retraction 

Dr. Calabrese: 

I happened to be at a large gathering of distinguished scientists today, most of 

whom have published in Science, and l asked them the following question: 

"Do you believe it would be pem1issible for Science to retract your paper (or any 

other researcher's paper) based on evidence put forth by a third party claiming 

<f) Springer 
293 


33371.274

Calabrese 

scientific misconduct, without allowing you the opportunity to rebut the 

claims?" 

There was not a person who believed that it would be appropriate or ethical for 

Science to retract a paper under those circumstances. Examples that were given 

by this distinguished group for why due process needed to be given to both sides 

before action is taken included: 

Possibility of conflict of interest on the part of the third party: 

Situations in which so-called "evidence of misconduct"' was taken out of 

context and either misinterpreted or purposely misrepresented; 

Limited knowledge of third parties as to the entire story; e.g., believing that 

a result was based on X when it was based on Y. 

You obviously answer "yes'' to the question above, otherwise you would not 

continue to press this issue, but you are the only person I have encountered so far 

of that opinion. Science will not be changing its policy. 

Please respect that the matter is closed. 

Sincerely, 

Marcia McNutt 

Editor-in-Chiet: Science family ofjoumals 

American Association for the Advancement of Science 

1200 New York Avenue N.W. 

Washington, D.C. 20005 

~Springer 
294 


33371.275

The Honorable John A. Barrasso 

Chairman 

merican· 

Chemistry 

ouncil 

Committee on Environment and Public Works 

United States Senate 

Washington, DC 20510 

Dear Chairman Barrasso: 

On October 3, 2018, the Senate Committee on Environment and Public Works 

Subcommittee on Superfund, Waste Management, and Regulatory Oversight held a 

hearing entitled, "Oversight ofthe Environmental Protection Agency's Implementation of 

Sound and Transparent Science in Regulation." During the hearing, Senators Booker and 

Carper recommended that EPA release a chemical assessment of formaldehyde generated 

by EPA's Integrated Risk Information System (IRIS) program. EPA has a duty to ensure 

its regulatory decisions are grounded in a thorough and objective review of the best 

available and most relevant scientific evidence. A public release of the draft formaldehyde 

IRIS assessment would be premature and would circumvent EPA's current review 

practices, which include a multi-step intra-agency review by other EPA programs as well 

as an inter-agency review by other interested federal agencies in advance of any public 

release. This review process is particularly important because, numerous stakeholders, 

including the National Academy of Sciences (NAS), 1 have repeatedly raised concerns 

about the scientific quality of assessments generated by the IRIS program. 

The American Chemistry Council's Formaldehyde Panel (the Panel)2 has continued to have 

concerns about the EPA's draft formaldehyde IRIS assessment. In a January 2018 meeting 

between the Panel and EPA to discuss the formaldehyde science, EPA staff specifically 

stated that the revised IRIS assessment of formaldehyde would not rely on a mode-ofaction framework to integrate the available science, a direct contradiction to the 

recommendation of the NAS in its 201 I report.3 In the past, IRIS assessments have relied 

heavily on epidemiological data to draw conclusions, while sometimes ignoring or 

discounting relevant toxicological and mechanistic, or mode of action, studies. This 

approach is outdated and inconsistent with currently accepted risk assessment practices 

regarding the necessity of integrating all lines of scientific evidence to reach scientifically1 National Academy of Sciences (NAS). National Research Council (NRC). 2011. Review of the Environmental 

Protection Agency's Draft IRIS Assessment ofFonnaldehyde. Committee to Review EPA's Draft IRIS Assessment of 

Fonnaldehyde. Board of Environmental Studies and Toxicology. Division of Earth and Life Sciences. Available at 

http://ww\\'.nap.edu/catalog.php?rccord id'-' 13142. 2 The Formaldehyde Panel represents U.S. producers, suppliers and users of formaldehyde and formaldehyde product,. 3 The NAS 2011 report recommends that EPA "Select outcomes on the basis of available evtdence and understanding 

of mode of action" and the report also notes "A clearer presentation ofiriformation with more tables that summarize 

available s/udies. figures that synthesize related effects from multiple studies (see Figure 6-2), and greater integration 

of information about mode of action and potentially susceptible populations during study selection and assignment of 

uncertainty factors would improve the assessment's ability to make a compelling case.. " 
295 


33371.276

defensible conclusions. It also fails to meet the scientific standards required by the 

Lauten berg Chemical Safety Act.4 

EPA's Acting Administrator Wheeler has prudently decided to conduct an internal review 

of the IRIS program to ensure the substances being evaluated reflect the priority regulatory 

needs of the EPA program offices. The Panel hopes that this review will be broadened 

beyond priority-setting to also include a review of the scientific rigor employed by the IRIS 

program, including the program's application of science-based safe thresholds for chemical 

exposures. 

As evident in the October 3'd hearing, transparency and application of current scientific 

knowledge are critical for effective regulation. A scientifically-flawed IRIS formaldehyde 

assessment could lead to unwarranted concerns regarding exposure. EPA must not take 

such an outcome lightly. Given the previous concerns raised about the IRIS program, the 

Committee should endorse the efforts by Acting Administrator Wheeler to review the 

fom1aldehyde assessment to confirm the scientific basis of the assessment before releasing 

it publicly. Acting Administrator Wheeler should be commended for his efforts to ensure 

the best available data are used to draw conclusions about potential health risks to avoid 

creating unfounded consumer fear and prevent undue economic impacts. EPA must be 

allowed to conduct its full internal review without being constrained by artificial deadlines 

or having to truncate its review unnecessarily. 

Sincerely, 

Kimberly Wise White, Ph.D. 

American Chemistry Council (ACC) 

Senior Director, Chemical Products and Technology Division 

On Behalf of the ACC Formaldehyde Panel 

4 Section 6(b)(4)(F)(i) of the Lauten berg Chemical Safety Act requires risk evaluations to integrate and assess available 

information on hazards and exposures for the conditions oF use of the chemical substance. Additionally. Section 26(i) 

requires EPA to make decisions using a weight of scientilic evidence approach. 

americanchemistry .com Y 700 Second St., NE I Washtngton, DC 20002 I (202) 249.7000 
296 


33371.277

merican· 

Chemistry 

ouncll 

BEFORE THE 

SENATE COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS 

STATEMENT FOR THE RECORD OF THE 

AMERICAN CHEMISTRY COUNCIL 

October 3, 2018 

The American Chemistry Council (ACC) appreciates the opportunity to provide this 

statement to the Senate Environment and Public Works Committee regarding EPA's 

proposed rule, ·'Strengthening Transparency in Regulatory Science." ACC and its 

members have a strong interest in EPA's adoption and implementation of the proposal that 

will strengthen the science EPA uses to make decisions. 

ACC believes that EPA's proposal correctly codifies an important good governance 

principle: that government agencies should be as transparent as possible, within the 

bounds of the law, about scientific information they rely on and the justifications for the 

significant regulatory decisions they make. 

EPA's proposal builds on the principles underlying the Administrative Procedure Act 

(APA), Executive Orders 12866, 13777, and 13783, and guidance developed by the Office 

of Management and Budget (OMB). In our view, the proposal is consistent with these 

foundational elements. 

In particular, ACC supports the proposed expansion of the Office of Science and 

Technology Policy's (OSTP) 2013 memorandum entitled "Increasing Access to the 

Results of federally Funded Scientific Research." The proposal directs federal agencies 

and offices to develop and submit plans to OSTP, which ensure that, to the extent 

practicable, peer-reviewed publications and digital scientific data resulting from federallyfunded scientific research arc accessible to the public, the scientific community, and 

industry. 

The 2013 OSTP directive requires each agency to develop a public access plan that 

maximizes access to federally-funded "digitally formatted scientific data" 1 while also 

protecting confidentiality, personal privacy, confidential business information (CBI), 

intellectual property rights, and U.S. competitiveness2 In 2016, EPA issued its Plan to 

1 As defined in OMB circular II 0 as "the digital re-corded factual material commonly accepted in the 

scientific community as necessary to validate research findings, including data sets used to support scholarly 

publications ... " It is a definition consistent with that of'"research data" in the regulatory text of EPA's 

proposal. 

l More than 20 federal agencies have developed and implemented Data Access Plans, including EPA, the 

National Institutes of Health (NIH), the Center f<1r Disease Control (CDC), and the Food and Drug 

Administration (FDA). 

Second St., Wast1ington, DC 20002 l 1202.) 249-7000 
297 


33371.278

Increase Acce,~s to Results of EPA-funded Scientific Research in response to the OSTP 

directive.3 Importantly, EPA's proposal on Strengthening Transparency extends these 

commitments beyond the government-funded requirement of the OSTP directive to "dose 

response data and models underlying pivotal regulatory science regardless of the source of 

funding or identity of the party conducting the regulatory science.'"' 

EPA's focus on dose-response data and models appropriately reflects the evolution of 

toxicology from a largely observational science to a discipline that applies advanced 

scientific techniques and knowledge. Research programs within academia, government, 

and private sector labs have greatly improved our ability to investigate and understand the 

underlying biological mechanisms, modes of action, and dose responses of toxicants. We 

can now e\'aluate biological events leading to toxicity and consider how (in a dose· 

response manner) these biological events relate to potential risks to htllllan health. This 

was not possible J 0-to-20 years ago. 

Importantly, these improvements should translate to: 

• 1l1e application of tratlsparent weight-of-the-evidence approaches to the assessment 

ofhuman relevance 

• The development of points of departure 

• The derivation of protective human health equivalent dosages that minimize the use 

of uncertainty factors and variability. 

EPA's proposed rule will promote the application of this knowledge to improve the 

scientific basis of government regulatory policies and industry product stewardship. 

For enviromnental concerns, exposure-response is the more appropriate relationship to 

evaluate because most of tl1e environmental test guidelines require quantifying 

concentrations in media external to the organism for use as the exposure metric. Toxicity 

information, and when available- knowledge of mechanisms, are integrated with 

exposure-re$pOnsc models for risk-based environmental safety decision making. 

ACC encourages EPA to implement best available scientific procedures under this 

mlemaking. The Agency should move away from the outdated linear concept of how 

biulogy operates toward biologically-based mechanisms, i.e., mode of action (MOA) and 

adverse outcome pathways (AOP) for both cancer and non-cancer effects, that clearly 

establish the threshold nature of toxicolob>ical endpoints for derivation of points of 

departure for establishing regulatory values and making regulatory decisions.5

•

6 

2 
298 


33371.279

As we noted earlier, EPA's proposed rule is consistent with and builds on policies 

implemented by previous administrations. In our comments to EPA on the proposal, we 

noted in particular that implementation would be aided by a policy statement or guidance 

that commits the Agency to afford greater weight to studies using validated lest methods 

and procedures, models, and approaches, when and where those data are based on publicly 

accessible data, and transparent computer algorithms. Guidance to assist implementation 

of the rule should include specific examples and/or case studies, perhaps drawing from 

recent EPA rulcmakings, to demonstrate what constitutes regulatory science that is 

material to EPA's significant regulatory decisions. Other scientifically relevant and 

reliable studies and data should not be eliminated from consideration, but rather, accorded 

less weight when integrating evidence from multiple studies within and across different 

lines of evidence. 

We believe the proposal is consistent with the relevant provisions of Section 26 of the 

Toxic Substances Control Act (TSCA), as amended by the Fmnk R. Lautenberg Chemical 

Safety for the 21" Century Act, approved by an overwhelming Congressional majority in 

2016.1 EPA's proposed rule is an important step toward ensuring that the science the 

Agency relics on in decision-making is transparent and accessible. 

7 TSCA Section 26(h)-(k) (15 U.S.C. §262S(h)-(k)) provides: 

(h) Scientific Standards.-ln carrying out sections 2603, 2604 and 2605, to the extent that the 

Administrator makes a decision based on science, the Administrator shall use scientific infonnation, 

technical procedures, measures, methods, protocols, methodologies, or models employed in a manner 

consistent with the best a~Jailable science, and shall consider as applicable-

( I) the extent to which the scientific information. technical procedures, measures, methods, 

protocols, methodologies, or models employed to generate the information arc reasonable for and 

consistent with the intended use of the infonnation; 

(2) the extent to which the information is relevant for the use of the Administrator in making a 

decision about a chemical substance or mixture; 

(3) the degree of clarity and completeness with which the data, assumptions, methodst quality 

assurance, and analyses employed to generate the infom1ation are documented; 

(4) the extent to which the variability and uncertainty in the information, or in the procedures, 

measures, methods, protocols, methodologies, or models, are evaluated and characterized; and 

(5) the extent of independent verification or peer review or the jnformation or of the procedures, 

measures, methods, protocols, methodologies, or models, 

(i) Weight or Scientific Evidence.-The Administrator shall make decisions under sections 2603, 2604, and 

2605 based on the weight of the scientific evidence. 

U) Availability or lnformation.-Subjeet to section 2613, the Administrator shall make available to the 

public--· 

(1) all notices, determinations, findings, rules, consent agreements, and orders of the Administrator 

under this title; 

(2) any information required to be provided to the Administrator under section 2603; 

(3) a nontechnical summary of each risk evaluation conducted under section 2605(b); and 

(4) a list of studies considered by the Administrator in carrying out each such risk evaluation. along 

with the results of those studies; 

(5) each designation of a chemical substance under section 2605(b), along with an identification of 

the infonnation, analysis, and basis used to make the designations, 

(k) Reasonably Available lnrormation.-ln carrying out sections 2603,2604, and 2605, the Administrator 

shall take into consideration intbrmation relating to a chen1ical substance or mixture, including hantrd and 

exposure intOnnation, under the conditions of use, that is reasonably available to the Administrator. 

3 
299 


33371.280

Comnmntrlty 

~upons~ 

The EPA Cancer Risk Assessment 

Default Model Proposal: Moving Away 

From the LNT 

An lh~matlONi Jrn,r:-t~l 

July..Se!pt.ernh,r20l8:H 

@ ThrtAuthor(s} 1GI$ 

.A.rtitll) TeVJII: gul:delill6l~ 

qppub..tamljournab-petmb'iiuf!S 

001: IO.II17/ISS9ll~l8789tl<O 

!ovt:nitk."H.~\t~.:::omlhomdd~s 

®SAGE 

Edward j. Calabrese1

, Jaap C. Hanekamp1, and Dima Yat:ji Shamoun3 

Abstract 

This ar;l<le s~;rongly suppom the En¥ironm~ntal Prote~lon ~V,en<y proposal ~a make significant change> !n their cancer risk 

aSS<l$$ment principles and pra~ices by moving away from the use of the linear nonthreshold (LNT) dose-response as the defoult 

model An altemate approach is proposed based on model uncertainty which integrates the most scientifically suppomble 

features ol the threshold, hormesis, and LNT models to identify the doses that optimize populatian-basod re<panses (ie, maximize 

health benetitslmlnimlze health harm). This novel approach For cancer risk asseument represents a significant impravemant to 

the current LNT default method from scientific and public health perspective"-

Keywords 

un,er risk asseumentt model uncertainty, LNT, hormesis, thr-eshold, dos~nse, US EPA 

Linear Nonthre:d1old-lts Corrupt History 

and Scientific Flaws 

The proposal by the Environmental Protection Agency 

(EPA)' to no longer use the linear nunthteshold (LN1) as the 

default model in cancer risk assessment i:s long overdue, lt has 

been extens.ively docQmented that: {l) The LNT model has 

been based on flawed science (ie, Hennann J. Muller never 

indue* point mutations but rather large gene deletions and 

other gross chromosomal aberrntians2

; (2) the LNT model h•s 

incorrect scientifi-c intetpretations (ie~ .!'vluUer incorrectly 

t\!isumed that ltis: tran-sgenerational phenotypic changes in 

Drosophila were due to gene mutations)'; and (3) the LNT 

single .. hit theory has b~en formulated under the incorrect 

asswnption that the., Muller x .. ray indu.ced gene mutation theory was sound.1 

Further, the history of LNT has been ripe with deliberate 

misrcpr.,;entations of the scientific rocord, including (l) the 

incorrect <lismissal of the Caspari threshold findings by Stem 

and Muller (""'study by Calabresu4

) contradicting a copious 

research recQrd and substantial private cQrrespondence 

between Muller and Stem4

; (2) Muller's powerfully in!lueJJtial 

comments in his Nobel Prize Lecrure wore deliberately dece!)-

tive'·'; (3) scientific misconduct by the entire membership of 

the US National Academy of Sciences (NAS) Biological 

Effocts of Atomic Radiation (BEAR) I Genetics Panel which 

l<ad to goveromental adoption oftheLNT (ie,publisbing deliberately false information in the journal Science to enhance the 

acceptance of LNT; NAS llEAR I Genetics Panel, 19564

•

7

); 

and ( 4) serious errors on mutation risks that were introduced 

into the key Biological Effects offonizing Radiation (BE!R) I 

Report in 19728 which wen> adopted by the EPA in !975 

to justify the adoption ofLNT for chemicals and radiation?·10 

It is only recently th!!l the BEIR I mistakes and their perpehtotion to the present by other US NAS BEIR Committees and 

their risk as_sessment implications were reported. The LNT 

cancer risk assessment policy, procedures. and bolief system 

are based therefOre upon a newly recognized series of corrupt 

actions and mistakes by key national leaders principally in tile 

mdiation genetics domain. These controlling deceptions and 

1 Dep:~l"'l'T\-em: of Envkonmanta.l Haafth Sdenc:eJ, Univenity ~f Manac:htn:~tt'f. 

Amh<r.~; MA. USA. 7 Se:i~:nee Oepartm~f!t, Unive~ity CoU~ge Roosevelt~ Mlddelbu.rg, 'rlle 

l'lkltheri;J.nds 

3 £tt.momio Oepal"tment, Ur!.iv~r$fty of Taxu at Austin, Austin. lX, USA 

Con-espondlng Author. 

fdw!Jrd J. Ca1abrett".,.. O~~nt ot f"nviron:mantaJ HealthSde!'tt;~, lJnM!t$ity 

of Mas:sathu$ett:J. Motrilt I. NJ44, Ambl!rst. MA Ol®l,USA 

ernaU: edwardc:@!dtoolphumaSf,.~dli 
300 


33371.281

errors have guided the US cancer risk processes from the rnid ... 

1950s to the present. As important as these documented errots 

and deceptions for the LNT model are, a vast scientific litera1\lre exists that refutes the low-dose predictions of the LNT 

modeL u~!l,ll Also~ LNT fsUs outside the empiricllll as nu 

experiment would actually be poBsible to causally connect the 

perturbation of oome part of tl1e DNA by 1 ionizing photon/! 

genotoxic molecule that subsoquently would develop, over the 

organism's lifetime, into some disorder such as cancer. Linear 

nonthreshold sintply a5Sumes this by default. 14 

Given the present EPA proposal, its major challenge is 

whether a cancer risk assessment default model is needed, and, 

if so, what should it be? A defuult model in cancer risk asse5S· 

ment gets around the practical impossibility of testing agents 

for cancer risk over a large number of doses and with very large 

number of animals. This issue was: well demonstrated in the 

now famOWi Food and Drug Administration ED·OI study that 

utilized some 24 000 mice. 15 Such studies take too long, are too 

costly, ll!ld they reduce the possibility that other agents get 

tested, since vast resources would be directed to the massively 

larger study(ies). In addition, the EJ)..Ol study still could not 

explore the potential of very low risks without even a more 

substantial addition of mice. 

Based on the history of clunnic anini a! testing and tbe realization that large experiments were not practic"Bl~ the National 

Toxicology Program (NTP} adopted the long-standing historical modus operandi of using the simple few/high doses 

approach to hazard as-sessment based on the inadequate 

assumption that the LNT model could make accurate predictions in the low-dose zone. These few and excessively high 

doses, however, made it impossible to challenge the LNT pre· 

dictioos as a cancer risk assessment model. Thus, the NTP and 

the EPA worked together to create a system of evaluation in 

which the LNT model would become the default for cssentially 

aU animal model cancer risk assessments. 

The history of EPA risk assessment regulations has been 

based either on epidemiological or on animal model studies. 

In either case, knowledge of the nature of the "'sponse at low 

doS(:s affecting nonnal humans is limited:. For most regulated 

chemicals,. adequate epidemiological srudie..c; don't exist> and 

even ue.dequate•t studies have important limitations. The reality 

of this situation has resulted in regulatory agencies, .such as 

EPA. basing their human expoSUl'e standards on high dose/few 

dose animal studies with mice and rats, needing to extrapolate 

co humnnsJ often across many orrle:rs of magnitude of dose (eg, 

the history of volatile organic contaminants regulation illus--

trates this point). The questiou is how doos the EPA find a way 

out of this regulatory quagmin:: of using the hi•torically corrupt 

and scientifically flawed LNT model? The answer is not in 

basing regulations on mechanistic in vitro studies as helpfu1 

as they are, nor on limited and inadequate epidemiological 

studies as useful as they are, nor on the few/high-dose animal 

model approach. None of those approaches individually or collective}y can offer a solution to the issue of cancer risk 

assessment. 

Dose-Response: An lntemotional journal 

An Improved Default Model Approach: 

Model Uncertainty 

The best answer, for the foreseeable future, from theoretical 

data support and public health perspectives is the use of doseresponse model uncertainty, that is, using the le~ding doseresponse models and determining where they opttmally converge to yield the oo-called regulatory sweet spot. This "sweet 

spot" is the dose where health benefits are optinti.z~d, and risks 

are minimized. The resultant of these convergmg sciencedriven proce5ses will yield the optimal public health dose, with 

changes in dose going either np or down yielding less benefit! 

more public health harm, thus the sweet spot concept (note 1). 

In practice, this invotves fmding a practical and scientific 

means to integrate the thresbold, LNT, and honnetic dos<>-

response models, the 3 models with the most toxicological 

grnvitas based on the peer-reviewed published literamre. Each 

model has its strengths and limits, its advocates:, and its detractorS. In the interest of full disclosure, tbeauthots strongly favor 

the horrnesis model and feel it is far superior to the threshold 

model and even more so to the LNT model- 1 

... 18 Nonetheless, it 

is argued here that the combination and integration of these 3 

most substantial dose-response models into a dynamic risk 

assessment framework works best because it has the potential 

to integrate the best scientific features of the 3 models while 

limiting/minimizing the possibility of error. 

Ttlis process describes/predicts what happens if borrnesis is 

correct or incorrect and the same for the LNT as these 2 models 

provide the bounds of harm or benefit. The case for this integrated dose-response approach has been published in several 

peer-reviewed chemical and radiation health risk assessment 

publications. 4

•

19•

20 Attractive features of this integrative 

approach are that the nadir of the hormetic dose response, 

based on a large nwnber of studies in the bonnetic database, 11 

and the ~·safe" exposure estimate using the threshold doseresponse model with a standard 100-fold uncenainty factor 

yield essentially the same value. Thus, these 2 models provide 

an agreement, although they offer a different toxicological 

interpretation (ie no effect/safe tlu'eshold interpretation v.ernus 

beneficial horrnetic interpretation). At this same dose, the LNT 

model was found to yield a cancer risk approximately I a-• (or 

1 per 10 000 people over an 80-yoar lifespan). This value 

represents a low risk within society, which is not detectable 

via epidemiological evaluation under tho best of research conditions. It is also about 500-fold lower than tl1e caocerrisk from 

background (ie, spontaneous tumors). Figure f provides a. 

description ofL'te integration ofthe threshold, LNT, and hormesjs models within a model uncertainty framework, showing 

the optimized dose (ie, the regulatory sweet spot). If the hor· 

metic dose-response model predictions are correct> then the 

benefits to society in terms of disease reduction would be substantial, However, if hormesis waS wrong and LNT is correct1 

the effects would be undetectable, again showing the regulatory sweet spot. 

The integration of the 3 most oredible. scicctific mudcb 

within a model uncertainty suggests that more research still 
301 


33371.282

Calabrese ot al 

Figul'e l.lntegratfon ofhormests and tNT for risk assessment. LNT 

Indicates linear nonthr.e.shold. 

needs to be Wldertaken to improve the reliability of modelbased, low-dose estimates. It also raises the po..,ibility that this 

general appro11Ch might be able to be refined and fine-tuned so 

as to be applied to specific agents. For example, it is possible/ 

likely tllat the honnetic optima may Vllry somewhat depending 

on the specific agent. Despite the remaining uncertointies of 

this proposed model uncertainty and dose optimization regulatory sweet spot approach, it offers considerable scienti fie and 

societal advances over the present LNT model and should be 

adopted by the US EPA and other environmental regulatory 

agencies in other countries. lt offers a strong scientific foundation, the integrated estimates of the 3 most evaluated models 

and it e-rrs on the side of safety} while allowing society to 

capitalize on the potential ofsignificant public health benefits. 

This perspective is far superior to the current LNT -default risk 

assessment both from scientific and from public health per .. 

spactives. The EPA proposal should be accepted and implemented across all programs involving risk assessment as soon 

as poliSible. 

Authors' Note 

The US Government is authorized to reproduce and di:;.tributc for 

governmental purposes notwithstaading any copyright notation 

thereon. Th~ views and conclusfon!i contained herein are those of the 

authors and should not be intel-ptetcd as ne.cessarily representing policies or endcnernent, either expressed or implied. Spot!so~ bad no 

involvement in 11tudy design. collection, analysis, interpretation. wrif,. 

ing and det.iGion to and where to submit" for publicntion consideration. 

Acknowledgments 

Edward J. Calabrese acknowledges. longtime .support from the US Ah' 

fo[ce {AFOSR FA9S50-13-1-{)047) and B,.xonMobiJ Foundatiou 

(818200000000256). 

Declaration of ConRicting Interests 

The author( iS) detlarcd ng potentia\ conflict5 of interest with r~spect to 

the rc:search, authomh[p, and/or pubHCf:ition oftbi5 article. 

Funding 

The author(s) disclosed receipt of the following :financial support for 

the ~earch, author.sbip, and/or pablicBtion of this article~ Received 

longtime support from tho US Air Force (AFOSR FA9550-13·l-0047) 

and ExxonMobi1 Foundation (S182U0000000256). 

Note 

l. lt is worth noting that the ••optimal dose .. or the "swee-t spot" 

propo!>Cd jn this article is only based on llie dos~sponse science 

in cancer risk assessment. A wor)c in progress by Dima Slnunoun 

and Richard WiJliams expands on this idea of optimal dose by 

marrying r::canomicanalysis (in the form ofbenefit""'(lost analysis) 

with dose-response modeling. The idea is that the optinml dose 

occunt where lhe marginal cost is equal 11J the marginal benefit of 

the reduction in d.ase. This ecottr)mically optimal dose would 1ake 

into account reguliltory costs, various administrative costs, com~ 

pliance costs, and risk-risk trn.de .. offs and health-health trade-offs. 

A3 a result of t}tis comprehewrive: calculus, the ecooomica11y optiw 

mal dose may o~ur ilt a. doie higher than the optimal dose proposed h~re yet maximizing the. net benefits of B risk-ba~ed 

regulation. s~, for e;J.aruple, Keeoey?1 

Referencas 

J. Environmental Protection Agency (EPA). Proposed rule. 

Strengthening transparency in regulatory science. Fed Reg. 

2018;83(83):18768-18774. 

2. Calabrese EJ.FJaws in the LNT single--hit model for cancer risk: 

an historica:l assessment. Environ Res. 2017;158:n3 .. 788. 

3. StadlerU. The gene. &ience. 19S4;120(3125):81l·819. 

4, Calabrese EJ, Shamoun DY. Hanekamp JC. Cancer risk assessment: optimizing human health through linear dose-respon:s.e 

modeL Fwd Chem Toxlcal. 2015;81:137-140. 

5. Calabrese EJ.Muller's NobeJ J~crure on dos~>respoase for ionizing rndiation: ideology or science? Arch Toxicol. 20U;85(12): 

1495-1498. 

6. Calabrese EJ.Muller's Nobel Prize lecture: when ideology pre~ 

vailed over science. Tox Sci. 2012;126(1):1-4. 

7. Anonymous. (icnctic effeob of atomic radiation. Science. 1956; 

123·124(3209):1157-1164. 

8. National Academy of Sciences {NAS)!National Research Coun· 

cit (NRC). T11e Effoct.s vn Popularions of Exposure to Lew Lrrvels 

of lonUing RadiaJion. Washington. DC: National Academy; 

1972. 

9. C.1lab~e Rl The threshold vs LNT showdown: dose rate findings 

exposed flaws in the LNT modeL Part 1. The Russe11-Muller 

dobato.Environ Res. 2017;154:435451. 

10. Calabrese FJ.The threshold vs LNT showdown: dose rate findings 

e11;posed flaws in lhe LNT model. Part 2 How a mistake led BEIR 

I to adopl LNT. Envir<m Re>. 2017;154:452458. 

1 L Calabrese EJ, Blain RB. The hormesis database; the occurrence of 

honnetic dose responses in the toxicologicallitetoture, Reg Tox 

Pharm. 2011;61(1):73·81. 

!1:. Luckey TD. Radialion Hormesis. 1990. Brn::a Rat-on, FL: 

Lewis Publishers. 

13. Sanders CL. Radiation H<mne.sis and the Linear~No-Thresltold 

As~umptWn. 2009. N~w Y<"Jrk, NY: Springer Sc~cnc..: & Bu~ines-::lo 

Media. 
302 


33371.283

14. Hanekamp lC, Bast A, Helsloot I. Tilefliiwed Iagie of LNT-a 

shcrt anaiy.rls. 2015; Docket ID NRC-201~057. 

15. Bruce RD, Carlton WW, Ferber KH, et at.; Society of Toxicology 

EDOI TaskForce. Rc-cl'C.aminatil)n of the EDOl study-adjusting 

for time 011 study. Fund Appi Toxlco/. 1981;1(1):67-1!0. 

16. Calabrese ID.Honncsis: wh.y it is important to to:<ic('llogy and 

toxicologists. Errviron Toxicol Chern. 2008;27(7):1451-1474. 

17. Calabrese EJ. Hormesis is central to toXiCology, pharmacology 

and risk ••sessment. Hum Exp<r Toxica/. 201Q;29(4):249-261. 

18. Calabrese EJ, lavicoJi I, Calabrese V. Hormesis: its impact on 

medicine and health. Hum Exper Tax/col. 2013;(2}:120.1.:52. 

Dose-Responso: An lntomodonol journal 

19. Calabrese EJ. Model uncertainty via the integration ofbonnesis 

and LNT as the default in cancer risk assessment. Dai~~Responsi!. 

2015b;l3(4):J-5. 

20. C~labresc EJ, Shamoun DY. Hanekamp JC. The integrntion of 

LNT and honnesis for cancer risk assessment optimizes public 

health pmtection. Health Phy.r. 2016;110(3):25(;.259. 

21. Keeney RL. Understanding life-threatening risks. Risk Anal. 

i995;15(6):62Hi37. 

22, Calabrese EJ. On the origins of the linear no--threshold (LNT) 

dogma by means of untruth!!, artful dodges and blind faith. 

E11vlro11 Res. 2015;42:432-442. 
303 


33371.284

Environmental Pollution 

From Muller to mechanism: How LNT became the default model for 

cancer risk assessment* 

Edward J. calabrese 

Drputttnent tJ/EmrlrMmerttol fk.alth Sdenres, MordU f, #344, Uraiwrsfty of Ma.wtdntsettl, Amllertr. MA,.liU/03, USA. 

ARTICLE INFO ABSTRACT 

Attidehittoi)P. 

ltl!cel\IM 4: AprU 2.018 

~16M~2Gt8: 

Avail®le t~nlihe 21 May :Uil8 

This paper Stltnmarim the historical and scientifk: fuundations of the Uoear No--Threshold (LNT) :c-ancer rtsk as~men.t model Tht: story of caru:er rlsk assessment is an extrdotdinary one: a~ lt w.1s based on .an initial incorrecr gene muratlon interpretath:m: of Mutler. the applkatio-n of this lne:orte-e:t assumption ln 

th~ dertvation:of thelN't single~hlt model, and a S(!ries of actions by le-ading radiation geneticists during the 1S46-1!J.56 period, iru::tudlng a NatkiMI Academy of Sctences (NAS} Siological Effl.l'cts of Atomic 

Rad~tion {lffiAlt) l Genetics Panel (Anonymotl$, 19S6), to sustain the LNTbefieJvia 41 series of deliberate obfuscations. deteptioru: and misrepresent;:~tiom that pro-Vided the basis of modern cancer risk assessment pol~cy ;md pr-<tctkes. The reaffirming of the tNT model by a: subsequent ~nd highly influential NAS Bio{(lgital Effect.<~: of fQnizing kadlatkm: (BElR.} J 'Committee (NAS/Nk.C, 1972) uslng rrtOuse data bas now 

been found tnbe inappro-pti~lte based on tbe discovery of a significant documented error in the bbtmkal 

control $«)Up that ted to incorrect estimatitms ofdsk in the low dose zone. Correction of this error by the 

wi_ginal s<:ienti5ts and the application of the ~j.usted[corrected data b~e.k t-o the :SEtR i {NAS/NRC, 1972) 

report lndlc:ate:s. til at the datjl W1luld have supported a. thres:hotd rather than the tNT model. Thus, cancer 

risk ilSsessment has a poorly appreciated, {::ot(lple)l: and st.•riousiy flawed history that has undetmtned 

pollc:ies and practices of regu!J:tory .agencies in the U.S, and worldwide to tbe present: time.. 

1. lntroduo;tion 

While a tole of the :environment in affecting the occurrence of cancer has lnog been known (e.g., the occurrence of testicular 

:cancer in chimney sweeps) (PvH. ~ '> J:·; ). transitiouing this recog .. 

nition of concern into an experimental science proved to be difficult ~u seen ln the seties of f-a.Uures to induce skin cancer in animal 

models dudng the early yeats of the ZOth centUry. Finally, after !Thlny failed attempts, in 1918 Japanese resean:Jters made the experimental breakthrough bY the repeat:ed administration of coal 

tars to the ears of rabbitS to produce papillomas and carcinomas 

(V.<m:t1z,w,, ;wd khiiM~r'\/A, !~11.11~ This seminal finding paved the way 

for experimental researth to assess pos-sible environmental causes of cancer. 

Irta similar manner, researchers early in the 2oth century began 

to explore whether it W1IJI jlQSSible to iru!Lt<l! mutations in plants 

and animals ~ 'tn <, ). While it took nearly three decades, 

reported thilt X-rays induced gene mutations In 

,_ ThW 1)3.pil.t ha$ !'Je.efi recommended for aa:eptartce by R No'm.ck. 

E·mllil;6dd.mt; '"~\Yit.\f\,;i;,., ""'""}"' ;)1U'~ 'ihl. 

© 2018 Elsevier Ltd. AU rights reserved. 

fruit flies, narrowly beating three independent teams of botll:nists 

who reported inducing ttansg<!nerational pheMtyplc 

changes X-rays/radimn.; Muller's findings, like that of the 

Japanese -tan<.:er researchers. quickly transformed the field. For his 

disa>very. Mtt!ler n.u:etved the Nobel Prize in 1946., Tbe current 

paper clarifies the historical foundations of the tNTsingte.-hit doseresponse model. its unique dependence upon the gene mutation 

interpretation -of Multer in 1927. and how tbis interp-retation 

became accepted by the scientific community and regulatory 

-agencies, Most importantly, it will be shown that: (1) MuUer•s claim 

that the X-ray-induced transgenerati-onal phenotypi~ changes weredue to mutations was an interpretation Jacking convincing 

evidente~ tile induced transgener.ationa.l phenotypiC: changes 
304 


33371.285

200 f.J. (alabRst I t:nl'iromrumtcf llftlk.uWn 241 (J0f8) 289--JDl 

were due to <:hromosomal deletions and aberrations~ not Muller's 

proposed gene "point mutations"; (3) these devehl{)ffilm~ unde~­

mtne the historical and sclenrific foundations of the I.NT smgle-hlt 

model since it was built upon Muller's gene mutation interpreta~ 

tion {see for a ~ignitkantly exp~n~~d analY~i~ or this is-sue); (4} Muller and other leading US. ra:d1a.tJon genenctsts 

would toUude in a series of artides to promote- acceptance -of the 

tNT, l:'llaking deliberate deceptions and misrepresentations of the 

scientific record; would infiltrate and 

health agencies in 

h (6.} the mouse data used to prnvlde expedmental basis 

for the subsequent reaffirmation of the- LNT for cancer risk assess~ 

mentwas similarly problematic. that is. the SEIR f i'~U\;;,"-,1\; 

Comniittce used a flawed historical control group that signiftcandy 

overestimated risk in the low dose zone, yielding a linear dose 

, ); {7) use of a corrected historical 

a threshold rather than the linear dose 

assessment indicates that the LNT has 

n.nional and international 

2.. MUller and mutation 

Hermann J, Muller, a radiation gene-tidst at the University of 

Texas/Austin, truly b-urst up<>n the national and intematim'lal sc:ene 

foHoWin_g his presentation ut the 5th International Genetics 

Congress in Berlin during September 1927, His highly anticipated 

presentation convincingly demonstrated to an eager and massiv"e 

from around the world that X-rays could 

transgenerat1onal t:Jhenotypic dlimges in Drosophila 

perhaps _providing a mechanism fur evolution. Muller claimed tl:ta:t 

these t;:hanges were the result of induced gen!:! mutation, tiny 

genomic changes, with MuUer coining the terrn "point mutation". 

MUJl€1' not only daimed to be the first to c:ver artificially induce 

gene mutation, he produced copious numbers of them. Muller's 

presentation drew especially great anticipation since in 

tbe Science, pubJished about three months only 

some of the new findings, inexplicably failing to show 

any data. Thus. MuUer. with a flair fur the dramatic, disproved the 

doubters and set himself on a path that 19 years: later would result 

in another trlp to Europe, Stockholm, to receive the N'obel Prize in 

Biology and Medicine. 

Multer's stunning results soon inspired: (1) numerous lab-oratories ro redirect their tcsearch to the assessment of lonirJng ra"' 

dlation induced mutations (, ~''''i P:l; > ): {2) the cr~ation of the 

Genetics Sru;iety of America (GSA} (1931) a few years later, bringing 

zoologists and botanists who were researching genetics und!:!r one 

integrated pr<lfes.sional society; (3) the concept of a Proportionality 

Rule that describes the Une3r dose response for the. ionizing radiation induced mutation response {7',1,1i'>:'L i'(1L\l); (4) the interdiscollaboration of leading physicists and radiation 

ttl create the lir-st mechanism-based cancer risk 

assessment modei (LNT siog1~-hit model) using target theory 

(5) the discovery of chemiAuerbach in the 1940s 

(,\,w,i'JAe!i The reach ofMutlerwa:s long and 

influential, inspiring the focus of ',in her semin,al book 

Silent Spring, that is narm~Uy given credit for starting the envJ .. 

ronmental revolution of the late 1960s a.nd 1970s and -continuing to 

powerfully supportive review of Silent' 

tne l'rew York Herald Tribune published on the Sunday 

prior to the book's publication four ti-ays later ( \4rdh"t 

the x~ray induc-ed "gene" mutation findings of Muller and 

leadership over the next 40 years would profoundly affect the 

environmental movement and the fields of genetic toxicology. 

cancer risk assessment and numerous medical, radiatio-n and pub he 

health practices, , , There is therefore little question that Muller had a major mfiu~ 

ence on ttte scientific community and the general publk, Qrigj~ 

nating from the belief that he had actuallY demonstrated that X· 

rays produce gene mutations in the fruit fly, While the above 

summary highlights some of the societal impact of Muller. thetl' are 

important parallel mncerns with Muller's sdentillc legacy, ln brief, 

\:ull\'<", ;,;·l~'',',,\i made the critical assumption that the numerous X~ 

my induced transgenerational/heritable plwnncypic changes that 

he were the result of induced gene mutations. MuUer 

knew transgenerat!onaljberitable phenotypic changes via Xray*ind\lt:ed chromosomal aberrations was not a significant finding 

n:dJ)i1\, (Zi/:lb). This had been reported previously and would not 

affect an understanding; of basic biological themes such as evolution and its potential mechanism. This was why 

entitled his grounclbreaking july 2Z, 1927 artide in Science •the 

Artificial Transmutation of the Gene". 

3. Point 1nntations vs gene: deletions 

Within three months of his presenting these findings at the 

Genetics Congress' in Berlin (September, 1927) (%•\'11;,,, i•lii't>,,), 

i\!l.-1"'-'\' · 1 ~'Lr :·h" w-ou1d pub!ic:.aUy express concerns that some might 

think that .all he h~1d done was to shoot large holes fie., deletions) 

throughout the genome with the high doses of X-rays used, noting 

that such concerns/questions were initiated by his longtltne ftiend, 

close w!laborator and confidante, Edg<lr Altenburg. a 

professor at Rice University-. Within this 

defensive at the December 1927 AMS meeting at 

ville, Tennessee and in an April192S presentation to the U,S, National Academy of Sciences (NAS) 1\iillt"'r tried t& discount 

the possibility that his reported transgenerational yhenotypic 

changes were due pdndpaJJy to heritable chromosome changes, 

suggesting as proof observations of reverse mutations {e.g .• x---rayinduced reversibl-e changes in eye c-olor- red to white), 

would subsequently publish a massive 82-page 

paper supporting his argument. this was proof enough for Muller 

that X-rays induced small mutations tn genes rather than vast and 

large deletions as by Altenburg, Muller used apparent 

reverse mutation tD preempt potential to his 

gene rnuhnk:m. Mulier argued further the 

assumed point mimicked the type of gene mu~ 

tatkm changes underlying the met:hanism of evolution as might be 

seen with spontaneous gene mutations, spending much of the next 
305 


33371.286

EJ. Qllabrffi? 1 tJtviruniiW!tnl Pollt~tion 241 (20111) 28.9---3Q2 291 

T.able1 

Stadler'S~UengeroMu!ler.quoresfrom '" ,,,,,' 

~~~~~\~~:~ ~!':!!,~~~~=~;~not to explain It but metef)' t4l<~bel itt 

:::: ~~~! :emonstrate that a chemica! change has ccrut·red; we simply infer, s:luce 110 methankal explanation can b~ fnund, th-'t the variation must be due to this 

hwlsible methanlsm." 

~;!:define mutation as: a tta.nsmisslbie'change in tfit' gene~Butwtt identify mutation by cxpoerimental tests, and ~hese tests are notsudt as to .establish. conclusively, ln 

s:pa:ifk ins:tances, that a Change within the gene has octutrt>1l" 

~~~J:!. any MendeUrlng varf~tltm whkb cannot 1:re shown to be du~ to a th.ange lnvDl:v!ng more than one gene is a mut;ttfon." 

~~h~ !ccurrena: of re~u:ion is not ptoofthat the l)riginat mut-.Jtion could trot h<lve bt!cn due t"Vrm to a defitiency,"' 

P.ag7292 

4() years in this quest for a mechanism for evolution. 

While these findings would temporarily satisfY the questioning 

and doubtful Altenburg and other-S. supporting the X~ray~lnduced 

point mutation interpretation, thfs concern would not go .away but 

actually grew principally due to the persistent questioning and new 

research insights of the plant radiation geneticist "'~,, 

\'Yi.4-., Muller's most staunch, yet objective, respected, competitor 

and critic (()\,';bt\'"r 

4. Stadler d:lallenges gene mutation interpretation 

4.1. C'ytugenetic advances 

At the time of his groundbrealdng mutation publication, 

research suffered from an acknowledged limited cytogenetic evaluative capadty which prevented fine structure chromosome resolution (".,. Drosophifa cytology is eh.tstve in its 

finer details"- page 721, \tJJ:~th). and thereby a reduced 

capadty to detect chr{)mosom.)i deletions. Markedly improv_ed 

chromosome cytogenetic resolution capacity wa.s developed by the Cornell plant cytl>geneticist, Barbara McClintock, in the prophase 

stageofmeiosiSwjth maize (~vt,: (1\:ci\}. Two years later she 

would apply this novel technique to Stadler;s x .. ray treated corn in 

the summer of1931. tt revealed that what was once believed to be X~ray induced "gene'' mutagens were :slz.eable duomosomal d~~ 

l:etions. While these findings would force St.ldler to re-evaluate and cllaJlenge his previously published induced mutational findings in barley (~;t,;;!'t', 

the question of whether Mulier's gene mutation interpretation 

with fruit flies was also incorrect. While Stadler woutd cautiously 

share his new doubts with the research community in several 193-1 

in private correspondence with 

genetks re:sea.rch Hke Karl Sax (:.{,{r<; '' 

would finally <:baUenga t-he MuUer gene mutation 

interpretation in a very public manner durittg his Plenary Address 

at the Sixth International Genetics C-engres.~ at Cornell Univel"sity in 

the presence of Muller ("Lllll" , ), 

From this opening round of public debat'e-, Muller and Stadler 

would challenge each other over whether Multer had induced true gene mutations in his highly publicized high dose X-ray experiments. This reseom::h~generat-e« debate would continue undt the 

de:ath of Stadler in 1954 (S! .>J,l$''' involving numerous radi .. 

atlo.n genetidsts to resolve fundamental 

research methods and experimental developments reveal a 

focused. high quality and prodw::tive research activity with 

numerous publications that challenged MuUer's gene mutation Interpretation {State Historical Society of Missouri, Stadler Papers). 

Au extensive review of Multer's gene mutation hypoth~sis along 

with supportive and non .. supportive literature findings is provided 

in the dissertation of ,,,t,,v,t;· ''1,;''', Stadler's Ph.D. student. In this 

instance Stadler would show his flair for excitement and setfronfidence by directing his student (with the assistance of 

Drosophila specialists -and with some formal assistance of Multer) to 

challenge Muller's gene mutation interpretation with Muller's own biological model. In this: extensive study,' <';''\-1 ,,., _ found 

no support for Mutters gene mutation interpretation ba"Sf"d on 

reverse mutations. 

To th~ outside viewer h suggested two outstanding sdentists 

iod<ed in a sdenttfic- dlspute., wtth Multer compelled to protect his 

reputation, future, and legacy, These longstanding competitive 

research activities of Stadler and Mufl.er were much like a bigh~ 

tevel chess match in which aU moves {e.g,, research publications, 

professional society presentations) contributed important inf'Or~ 

mation. By the late 1930s and/or early 1940s Stadler and others had 

metllodica!ly shown that Muller l<lt:ked the nettcted proof for his 

gene mut~tion assertions ''' ':,':,·,,). Th~ ~ubsequent 

development of Improved cyt:Ogtnctic staining for Drosophila 

chromosomes by i'>:;; would reveal that the use- of the 

very high x .. ray doses and dose rates similar to Multer's key findings, like that of Stadler's rese-arch with harley and corn, produced 

copious chromosome a*rrations including .a high of 

deletions, along wlth few. if any, possible gene "point") 

mutations. 

Muller's use of the reverse mutation conc-ept was also found 

unconvincing as multiple papers showed several mechanisms (e.g., 

positinn effect) by whlch reverse transgenerath:maJ phenotypic 

traits <:ould occur without in the gene, (Hent;:c~ 

move that Muller made 

of Stadler or spin-off ideas research had inspired. Furthermore. Stadler's and 

related publications would yield Insight's that were inrrementa!ly 

more definite. inslghtftd and over time, more convincing than 

Muller's, much like f-orcing Muller int-o a corner. 

~ Ste the dlsrussion from' dls:">et.ltinn: for a l:!et;~i.led assessmet~t nf 

revene mutatim'l. and position dfet:t as :retare.d to MuUer·s gerte mut;;~tlon 

intef'ptetath:nl. 
306 


33371.287

292 E..}- Cahlbrese f Environml'f!ml P4/lutfllli 241 (2018} 289-102 

4.2. McClintock's new X-Ray induced mutation me-chanisms 

Complementing the Stadler gene mutation criticism were new mechanistic findings of Barbara McClintocl{s study with her breakfusion-bridge--cycle model of X-ray induced genetic 

(t •':'Jhn;, lP:J ,:tll'll) which then led to strikingly trans~ 

formative transposable element induced mutational insights. Her 

novel mutable gene concept was particularly attractive- to Muller's 

University of Indiana Colleague .md future Nobel laureate dore tutia ' h >\L~} as well as 

closest and Edgar Altenburg. In the case of 

Altenburg, devote much effort to understand the sden" 

tlfic foundations of McClintock's findings and Its role in spontan®us and exogenously induced mutations, The McClintock 

discovery had very broad biological and biomedkal itnpticatloos. 

However, it would also take Altenburg back to his 1927 suggestion 

that Muller had been blasting large holes in Drosophila chromosomes by high dose X~ray treatments. Extensive and detailed CQtrespondence between Al!enhurg and McOintock in the "'rlY 1950s 

reveal the significance that Altenburg placed on her findings and 

how it stripped much significance from Muller's gene mutation 

model. 

transposable chroln<osomal 

-occurrence of both spontaneous and exoge--

nously mutations. induding mutations induced by 

ionizing radiatkm and dremical mutagens such as mustard gas .as 

used by Auerbach with Drosophila. Subsequent findings indicate 

that the early X-ray-indured transgenetational phenotypic llrtdlngs 

fl'A;\''?;;>and "L, \\H:,\Werelikely 

process massive such as 

small to massive deletions and other types of chromosol!l<d aber~ 

;/J' 1 \).These collective developments served 

ro strongly l'einfurce rhe fundamental criticisms bY Stadler of 

Muller's gene mutation interpretation, while supporting the 

McCHntock transpositional element mediated mutation modet 

S, 1M" singl•·hlt model, dose rate and the Manhattan Project 

While Muller was in serious dispute with Stadler throughout the 1930s for his gene nlutation interpretation. there was nonetheless a 

worldwide euphoria of Muller's mutation 

element of which resulted .in !ntc·rdit;dp.linary Qlllabnratit>n between leading physicists railS led by Delbruck and Timcifeeff-Ressovsl<y. 

From the mid-1930s their research provided the 1M" 

a hypothetical mechanistic basis via the use of target 

theory p,q:r,lc;zil.,,l.f"'S\'-'W'i<v z't HrT'l.), This concept was then 

transformed into a biostatistlcal model (.i.e,lNT Single·Hit model) 

which revealed that the shape of the dose response in the low doselone was largely a function of the assumed number of target hits 

required to :produce a gene mutatlo11{/;n,,,,,c 'I ''"'+l ). The fewer the 

hits needed to produce gene mutations the dqser the linear dose 

response fot g¢ne mutation wa:s: approached. 

Since his X-ray Induced gene mutation interpretation had 

:experienced serious scientific challenges and setbacks through the 

1930s, Muller needed another approach to redirect the mutation 

debate to restore support for his gene mutation inwtpretation and 

tow dose linearityrnodel and their integrative linkage, MuUer~s idea was an intriguing one that served, at least in part, both purposes. 

with a new application of a "dose x time""" constant" ex:pe:rirnent as 

seen in tJte Bunsen-Roscoe taw or with Haber's Law. Over the 

decade of the 1930s using his Rule Muller had 

asserted that x .. ray induced was progressiv¢ly 

cumulative and could not be repalred. As a result or these <:harac~ 

teristics the damage should be predicted by the total dose, not by 

dose rate. If the total dose hypothesis were true, then the dose 

response fur mutation should be linear at low dose. all the way 

down to a single ionization, Muller would test this idea in .a 
307 


33371.288

EJ, Cafabrrst I Envirortmmtall'cllution 241 (2(}18}289-3&2 293 

dissertation by Ray~Cbaudhuri at the University of Edinburgh using 

x .. rays and mature spennatozoa of DJW!Jphfla... The findings of this 

dissertation matthed up very well With Muller's predictions sup. 

porting the total dose/tNT hypothesis, these results provided 

support at .a critical stage to MuUer's gene mutation theory, ln fa<t, 

during 1\,·lull~< -" : HNhh ':Nobel Prize l-ecture, he cited the research of 

r;,'~V·'.itdm:nun;·;~r:N. . 

The problem with this newly adopted rlose-rate vs total dose 

strategy to defend the gene mui:ati011 interpretation was that the 

study of Ray-chaudhuri had a series of Important design and 

execution limitations, improvements and 

replication ( { In foH::t, there were so many 

limitations {e.g., sample site, quality control issues, 

d1anging animal models during t~e experiment. lacked documentation of essential methods, mqjor statistical errors, failure to 

coll-ect critical information). it suggested that the normally critical 

Muller might have lowered his academic standards in order ttr 

provide support to his sagging g:ene mutation interpretation. 

The Ray~Chaudhuri dissertation in some ways served as a pilot 

study for the far more substantial efforts lead by Curt Stern, University of Rochester. during the- Manhattan Project starting in 1943. 

Stem would lnittal!y direct an acute study by Warren Spencer, a 

highly regarded Drosophila spe<latist who was on leave from his 

faculty position at the College of Wooster (Ohio, USA), While the 

Spencer part oft he study went as planned, as!gnificantproblem for 

Multer, a paid <unsultant on this project, oo:urred when the data 

from the low dose chronic genetic, toxiCity study, ted by Ernst 

Caspari. revealed a significant dose-rate effect and a threshold for mutagenicity, contradicting the l-i',,l\-',(f\,'''-'Jlbsn 

elusion$. These findings by them.<elves had severe blow to 'the t.Nr single~ hit theory. "11lese 

preceded by 15 years uf research lead by Stadler 

weakened the plausibility ofMuUer•s _gene mutation interp:ratation 

and now at-ong with new tnechanisUc: insig-hts of MtCiintock on x~ 

ray .. induced mutations. This situation became sufficiently threatening to the policy goals of key leaders of the radiation genetic.'l. 

community such as: Muller and Stern who strongly advocated the 

adoption of the LNT single-hit modeL What happened next to the 

field of radiation genetics could not haw been predicted. 

The above set of events, which collectively placed the !Nr single-hit model at risk. set th~ what is 

"LNfgate" {i i\t'-bcv<:\', nf ''"''""""'" 

deceptions, and misrepresentations scientific record 

designed to ensure that the LNT single--hit theory would n~p1ace the 

threshold model for risk assessment. Thls s:eque:nce of 

events has been in detail ovet the 

historical 

~_IJ); i'}'<,l /i'), 

The tNT-gate actions were mediated via the leadership of Curt 

Stern and Hermann J. Muller during the second half of 1946, 

continuing for more than a decade. These efforts lead to the actions 

of the NAS BEAR l Genetics Pail¢! to sustain and lnteg:rat• these 

successful manipulations into the scientific record and government 

regulatory policies, These ideologic-ally directed activities would be 

guided by the academic "offspring" of Muller and Stem, sucn as Jim 

Crow, Bentley Glass. and other esteemed leaders of the radiation 

genetics community. The process became fully successful when the 

next generation uncritically accepted ,as scientific fa~t. the mistakes, 

deceptions, <.Uld mi.srepresent.adons handed dO.wn by the irons of 

the field. This is, in fact. the 4omain where key features of the fields 

of regulatory policy and cancer risk assessment are today. 

6. Saving the hit model 

The LNTgate process. had an unexpected spQntaneous origin. lt 

began when Ernst Caspari informed Stem. his supervisor, that his 

dose-rate findings co-ntradicted those of Ray~Cha.udhuri (total 

dose). As noted above. the obse.rvatJon of a threshold response for 

mutation was not onty not expected but, as: it turned out. actually 

"not permitted". resulting in Stern refusing to accept the Caspari 

findings{, ,;;;1 ;), Giving the appearance of objectivity, 

Stem blamed Caspari's threshold "discovery" on the use of a faulty 

oontro1 group that he inslsted was aberrantly high. Stern did not 

provide any evidence to support this critical judgment. However, 

Stern was aware of earlier publications with control group responses for this tnodel that supported the interpretation 

based QO prior correspondence ('~t:-r ~~ i'l '7t). either forgot 

this or refused to: share it. R-egardless, the Casparl year-long study 

had reached an impasse- with the Stem judgement, a major crisis. 

Showing some degree of jndependence. Caspari would not 

accept Stern's judgement that his control group -displayed aberrantly high values. He dove into the literature and found a series of 

papers, which explicitly addressed the control group question, with 

aU supporting his position ,,,,li). When caspari 

assembled these findings. Stern withdrew the control group critidsm. During this period, Cas pari inform~d M. Oemerec, head of the 

Genetics Department: for the,Carnegie Institute. of his mutation 

threshold dose-response findings and the problems it was cre-ating:. 

This prompted the influential Demerec to write Caspari asking 

"what can be done to save the hit model" (l ,,,,, ). this 

statement seemed to express what Stem .and Casp.ari might well 

howe been thinking. With the control group issue no longer a viable 

means to discredit the Caspari findings, the "save the hit model'' 

strategy of Stern became publishing the manuscript, but framing 

the diseussion to prevent the data from being accepted/used, while 

still showing rompetence of the rese>rch team, thereby 

the LNT/Ray-Chaudhuri framework. this seemed like the 

possible -outoome for Stern and Caspari. 

The stra~gy adopted was to assert that the Caspari data could 

not be accepted or used until it could b¢ determined why he ob~ 

tained a threshold in the chronic study, whHe warren Spencer 

obtained an apparent linear dose response a year earlier in an a-cute 

study with the same fruit fly model while working under Stern. This 

created a false standard, as the two studies had more than 25 

methodological differences; there would be rta possible 

meanstodetY!rminewhythestudiesdlffe:red(,,,,;, \,,y;_\\ ), The 

only way that this highly nuanced perspective (i.e., the recommendation not to use the Cuspari findings until it resolved the 

differences wfth the Spencer study) could have been published was 

if Stern was the journal (i,e., Genetics} editor and there was no peer~ 

this was most likely just what h-appened {f h 

fact, even though Stern proposed this unreatistlc situa~ 

tion, n~ one. of <:nurse, ever explicitly accepted this challenge over 

the next 70 years, induding himself, Caspill'i or Muller. lt 

tactical move in the broader strategy to "save the hit So 

cas-pari and Stern prepan:.>d this manuscript with this obfus-cation 

and sent it to MuUer for review on November 6. 1946 with Muller 

answering un November 12. 1946 (t , ' '\;'"':N, Jt t 1 ). MuUer indi .. 

cated that he was upset that C<!sp.ui found a threshold since this 

could be a serious problem for tNT acceptance and Stem needed to 

replicate the study (not to explain wby the Caspari study dlffered 

from the Spencer study as emphasized io the discussion as this: was 

impossible to do). Thus; Muller was fully informed that the stn:m·, 

gest study (i.e .. chronic exposure to ionizing radiation) w dJte (Le., 

Caspari experiment) showed a threshold for mutation one month 

prior to the Nobel Prize lecture of December 12, 1946 ('-' 

':t4t+b). The linearity supporting acute expo-sure experiment of Spencer had a series of methodological limitations (e.g, hladequat.c 

temperature control, inexplicably combining different dose~rate 

groups with the same total dose. inadequate X~ray machine 
308 


33371.289

"'' E.), CalabreSE' j En\lironmentcl Poflurion 241 (2018) 289-302 

r~tibratlon) that affected the reliabilil)l o[ tile low dose study results 

::,11 }. Yet Stem, Muller and others never identified such even in Multer's detailed review of this research 

), These crllicisms oftheSpencerstudy('"', "' c' 

were first reported more than six decades later 

moment of making scientific 

the world with his statement that is no 

possibility fur a threshold response ("no escape from the condusion that rhete is no threshold") to ionizing radiation induced mutation 

and that rlsl<S needed to be assessed via the LNT single-hit model 

(Nobel Prize lecture, D<c 12, Muller made this 

statement having seen the Casp.ari study not offering any 

tedmical orothercritidsm (tt;c.Jk, '' >fi<c ). Thus. a type ofcotlnslon 

began to take shape betw-een Stem, Caspari, and Muller to do as 

Demerec urged. tn a fottow up letter to Stern (''v1t!H~" HH,',') MuUer 

supported publishing oft he-Casparl paper since there weteenough 

caveats (i.e., obfuscations) and restrit;tions to make the paper non~ 

threatening to the 00 acreptance. 

In 1949 Stern manipulated or colluded with the leadership of 

Sdence to ensure tNT would he 

was treated 

earlier showing no data on his Prtze expert .. 

nor seven years later (1956) in the journal's dealings with. 

tit• fraudulent NAS BEAR I Genetics Panel publication (ci''"''iimh'' 

;'\t;). Here is how it happened, While the Stern research team 

hoped that the foUow~up replic.1tl0n studies would put an end to 

the caspari study .. created crisis. it simply cr-eated a new one, The 

first replication experiment {te., led by -a new master's student 

Oelta Uphoff) was unacceptable ro Stern, this time because the 

control group. was aberrantly tow. The control group's values were so outside the norm that Stem had to check with Muller who 

strongly affirmed (in writing) that the Caspart control group values 

were appropriate: while rejecting Uphofrs: (see l\'!,\>t0~'1\:+" Fil · ,, ' , ' 

for tbe letter correspondence documentation). The troubled Stem 

woufd go so far as to blame ber for having been biased [i.e., "may reflect a personal bias of the experime:nter,. 

with this leading to the low group values 

l;~;>h). This phrase was stated in the Discussion of the 

mdnuscrlpt that was sent to the Atomic Energy Commission (AEC) 

(mu.l Which was immediately classified), 1'his amazing statement 

should have raised a plethora of questions by the scientific community for Stem and Uphoff but it was hidden from view. For 

example, how did the alleged bias start? How long did it continue? 

How might lt have affee:t~rl other experiments, othet· team members and others. th.e data analysis and manuscript write up? A 

follow-up experiment by Uphoff alsn suffered the same fate with an 

aberrant control _group value. This situation was turning into a 

professional disaster, So the question was not just what -could Qe 

done to save the bit model but :also the reputations of Stern, Caspal'i, and Uphoff and other members of the Manhattan Project at 

the University of Rochester. Stern would again show his cr~tivity 

(or deviousness). Since essentially no one had read the classified 

material discounting the tesu1ts and blaming Uphoff and her 

alleged biases leading to the uninterpretable findings. Stern used 

his contacts with the journal Sdence to pub!i~h a one p-age technical 

note of the experiments of Spencer, Caspari, and Uphoff. fn this 

~imitcd technical note. Stern showed no transparency, negleding to 

mform tbe reader that he had found the low contool studies of 

Uphoff unacceptable less than a year be: fore and now he concluded 

these findings were fuUy acceptable. No criticisms of the Spencer 

mentioned despite its: obvious significant limitations 

~;p3 l }. Stern also reintroduced critidsin of the Caspar! 

study without evidence. tn this mini-meta analysis. Stem restored 

the lNf model, literally .. saving the hit model". ln tM finat 

paragraph,: 'nltmf ,,xg; promised the Science readers to 

pro-vide a comprehensive paper with methods, materials. missing 

data and other relevant information, Yet, they never dl<i 

Mull~r and Stern actually promoted the discredited findings of 

Uphoff while marginalizing the Caspari paper. More spedfkaUy, at 

the time Stern asked Muller to help resolv<! the Cas!)ilri·UPholf 

control issue, Muller had been studying spontaneous mutations fruit fly in his ongoing disputes with Stadler con~ 

«:rnin.g whether he induced gene mutation \1), 

Thus, Muller was sitting: on .a tre.asure trove of control gr-oup 

spontaneous mutation data. As noted earlier. in multiple letters to 

Stem, Muller unequivocally sided with the Qspari findings while 

rejecting those of Uphoff (01A'cc'"', !•). With this as 

logoe we now fast forward a few years and find 

rejectintt the t'asp;ati study based on this con~ol group 

being abnormally high, contradicting the literature, his own lfata/ 

publications and his multiple fetters to stern. whlle never providing 

proof for his statements. The evidence reveals Muller dishonestly 

.strow~ to discredit the caspari study, and preserve tNT, while pr<r< 

tect!ng himself from being accused of lying <luring ltis Nolle! Prize 

Lecture, The 1950 paper of Muller was just pr&eded and perhaps 

inspired by an artide by MO .. s Robley P. Evans in Scif:rtce ( l 

criticizing the LNT model, using the threshold findings of 

Casp.ari (C ;,',t!Y' J<uL>I}. After Moller read the Evans 

article, he wrote to Stern criticizing the paper of Evans, blaming the 

criticism of LNT on the findings of caspart (':vhd11"'', ;:•0iJ1 Muller 

Stern to contact Evans and discredit the caspad wofk. No 

found th-at Stem cotnmunicated with Evans 

on this However. shortly after tltat letter exchange with 

Stern, Mufler published his false criticisms of Ci\spari's control 

group. Furthermore. on August 10, 1949 "\itq~hqni ';t:h1~t,' wrot-e 

Muller about the Caspari threshold findings. ackoowledged the 

relial:>Uity of tlte findings yet in search of a medlanist!c.xplanarion. 

App:trently, Muller had thought that Stem and his efforts had fully 

neutralized the threshold findings or Caspad, but this was- not 

apparently the case. 

7, LNT and the NAS !lEAR Genetics panel 

Tlte next stage of the i..NT story would take place witf1 the NAS 

BEAR r Geneti~s Panel which first convened in early November, 

1955 at Ptinceton Un!versil)l. As Muller had learned from many 

earlier frustrations, success within Advisory Committees 1s highly 

dependent upon who is selected. In the cas-e -of the BEAR 1 Genetics 

Panel, the .answer was dear from ti1e start, as the Panelist Tracy M. 

Sonneborn, a Multer colleague at the University of tndiana. read 

their radiation geneticist mantra into the recorded proceedings 

with no debate or dispute. All finnly believed that mut.ationai 

damage was cumulative and irreversible with the dose response 

being ftnear down to a single ionization. Multiple notable radiation 

geneticists at that time were not advocates of the Muller perspective but they were either directed to other NAS BEAR r panels such 

as was the case of Ralph Sl!lgleton (agriculture panel) or not 

selected as was: the case of McClintock. In retrospect. tbe deek was 

stacked along with an administrative leadership that would keep 

the panet rO<:used on the big picrure goaJs of the RockefeUer 

Foundation {RF) that both funded and directed the Panel while in 
309 


33371.290

£.]. Calabme I f:'ln'!'romrnmfal Pa/!J.I('ion 241 (1aJS) 289-.JO.Z 

the administrative structure of the NAS, 

Despite tne endotsement ofthel.NT sing;lo·hlt model by leading 

research geneticists and physicists it was wtdeiy recognized that the fundamental data to support (he tNT single .. hit model was 

inappropriate. The model was dependent on point mutatiDns, not 

large deletions. gene rearrangements. and other gross aberrations. 

In his final and masterful paper, published posthumously in Science, 1 q~;4: would illustrate how Multer's mutational data could 

not provide a credible binfogkaf basis fut the LNT -Single-. hit model. 

Despite the prominence of the journal Science, the stature of Stadler 

and the timeliness of the arfide, this t:ritidsm of the LNT single-hit 

model was never discussed by the NAS BEAR l Genetics Panet In 

fact. not once in the transcribed pages -oi the P:anet meetings were 

Stadler orMcCfintod(s research on gene mutation ever mentioned, 

At the second meeting of the Panel (in ttdc~o)~ Warren Weaver, 

Chair of the Genetics Panel and Director of Research for Rf, tried to 

entice members of the Panel with RF funding if the Panel Report 

would support RF initiatives (e.g., LNn Weaver indicated he would 

"try to get a very substantial amount of free support for genetics if 

at the end ofthis thing we have a case for it. tam not talking about a 

fe'\v thousand do-llars, gentlemen. I am talking about a substantial 

amount of flexible and free support to genetidsts" {r;lE''I\'i<t!1:\1s, 

- BEAR I Genetics Panel Transctipl February 5, 1956, page 

35),'' Weaver would further state that "There may be some very 

practical results and here is the dangerous remark - don't 

misund-erstand m~ we are aU just conspirators here together"~ The 

Weaver remarks obviously link the Panel deliverables to RF fUnding 

for geneticists, intluding those :silting in the room. Further dis~ 

russians of rhe Panel duting the Februa<y S/6, 1956 meeringwou!d reveal that to be successful in the eyes ofWe-aver. the P-anel would 

need to present strong agreement/consensus for the estimation of 

genetic ris~ to the US, poput~tion assuming a linear tlose 

response. However. an unantic:ipated problem came about 4-5 

weeks later (March 1956) when the Panel members displayed 

multiple profound disagreements~ they argued about whether it 

was possible to .even estimate population risks, how to derive the 

estimations, how any derived estimates of damage related to true 

(real) risks, and what the risks actuatly were. With this confusion, 

the highly divergent results of the independent risk estimates that 

were carried out oVer 10 generations were seen as -an unusable sdentifk: "mess"~ su<:h that Panet member. jim Ctow, would daim 

that no one would believe the policy recommendations of the 

Pan~lists since they could not agree, amongst themselves. In a 

Match 29, 195& Letter to Warren Weaver,, '''1'\,V, t"J;,,, stated that: 

'The limits presented on QUf estimates of gene:tlc damage are so 

wide that the reade-rs will. I believe. not have any rontidence in thetn at all." 

lacking authority to dO' Crow. who was to organize the 

te<:bnicat reports for Panel decided to arbitrarily drop 

the threelowestestlmates of risk; by so doing he markedly reduced 

the variation, giving the false impression of more expert Panelis-t 

agreement than was the case. Even after dropping the three, there 

remained considerable uncertainty, being still too large to show to 

the scientific community and general public- One might have 

thought that the P;~ndists whose estimates were dropped would 

have strongly fought to have them retained. There is some evidence 

of signitkant disputes betw-een Demerec and Muller on this matter 

based on a letter rrom Muller to Beadle in August 1956 ,; tli} indicating that Muller did not want to be part of writing ,1 

scientific justification for their, LNT ret.'l>n'lmendation, He indicated 

that he was already too frustrated with his debates with Demer~c 

nver the value of Drosophila versos barter! a in their risk estimations 

and did not want t'O air the so .. calted dirty laundry in public. He had 

thought that they had agreed to disagree. However, the available 

record does not reflect the details ofthls matter, as: it likely octurred 

in the March t95'6 meeting once C:row received the detaited writeups for which no meeting transcript. Muller also noted 

his unresolved with the human geneticists of the Panel 

further unwillingness to seek a consensus report 

justifying rerommendations. This lack of blatant 

open dispute/rebellion suggests that the group consensus was to 

present .a united front that Weaver had earlier pointed ()ut was 

necessary, perhaps using this funding carrot tQ achieve agreement. 

However, panellst James Nee1, who refused to provJde an estinklt:e, 

strongly disputed the legitimacy of the proposed gen•tlc damage 

estimation attlvicy ("h,,,,; \ '').He argued that any consensus 

agreement was an illusion based on a seff..fulfiUing decision to 

reduce variability by forcing the use of similar models with similar 

prm::ess assumptions. Even With Crow stacking the the risk 

estimates were stU! too variable. teading Weaver Crow to 

encourageJroerce the Panel not to show their range of estimates to 

the outside world since it would destroy their ,credibility. The Panel 

would keep it private. There was no "minOrity" report nor leaking 

to the media. The "control"' of the group was evident as those such 

as Demerec and Neel would not publicaUy ch.lUenge the group view 

despite fundamental differences, 

& The N/\5 BEAR I Commltt .. Genetics panel sdem:e 

publication stoey 

The BEAR l Genetics Panel{JubUshed a major artkl.e in Science 

their findings and recommendations. This 

misreprtosentations of the Panel's 

research record. The involved the Panel stating that the 12 

geneticists of the Panel were- invited to provide estimates of genetic 

tisks for the entire US~ population expQSed to a certain dos-e of 

ionizing radiation. but only six accepted tbe dutUenge and provided 

the write up. Yet. nine of the 12 actually did, with Crow dropping 

three estimates as noted earlier., lfl' f<1ct, l had the nine 

detailed d»<•»H>OH'<>. O>C<;UUU, 

mhlimum and maximum damage range was 

±10 or 100 fold. Howevet the actual average minimufl1>-.maximurn 

damage range was about 750 fuld.Third, the Genetics P-anel Science 

paper negiected ro report that three Panelists refused tn participate, 

principally because they be-lieved that such estimates could not he 

reliably done. 

A written record exists that documents that the NAS BEAR I 

Committee Genetics Panel voted not to share their data with the 

scientific community and oth~rs (1 ,\). After the 

Panel's publication in Science it was specifically chaUeng~;~d by 
310 


33371.291

EJ. CQ.Iabrf.w 1 En\'Jrrm/fK'nt(ll f'oflutlon 241 {2018) 28!J-31J2 

several leading U.S. academic researchers to share the scientific basis for the report .and again the Panel formally voted not to do this 

as wdl :z,, ,,,), Of significance Is that the Panel had 

such a scientUk basis for their tNT recommendation, should be seen as failed leadership by tl!e Nl\S 

Ptesid'ent Dedev Bronk and Chairman Weaver, a sign of sdentific 

or a typ< of defense posture, the Panel vote during August, not to provide a scientific basis for thts major 

recommendation to adopt the LNT singl~?~hlt model fur risk 

assessment was then passed un to NAS president Bronk~ who 

accepted theirdedsion. The NAS arlmln!stratlon was therefore fully 

complldt in this process (<,;.i ,~.,,, 0 • 

The NA5 BEAR 1 Cnmmlttee Genetics Panel therefore falsified the 

research record. creating a significant cover up. Providing a detailed 

write up: of their process would have revealed th~ deliberate misrepresentations of the research tecord.lt would at so have revealed 

a highly embarrassing fundamental lack of competence by 

prestigious leading who could not 

address this risk problem, as 

amateurish and incorrect response(: ,\i.liY<'~ 

.also have taken considerable effort to complete a report, 

something that should hav-e been done during the activity of tile 

PaneL 

The goal of the NAS BEAR I Genetics Panel was to recommend 

adoption of the LNT in the US. and worldwide, Within aoout two 

years the tNT recommendation was adopted by national and international advisory committees. eventually becoming worldwide 

po.!icy for cancer risk assessment. Thus, the most significant policy 

reco-mmendation fur t:ancer risk assessment lacked a written sci~ 

entific basis. Most striking is that the: Panel. including MoHer, and 

the president of the NAS made this decision. It is ironic that the U.S. 

National Committee for Radiation Protettion .and Management 

(NCRPM) adopted LNT for cancer risk assessment in December 

1$5$, based on the documentation-lacking NAS BEAR I Genetics 

Panel report days prior to the publication of t\n!>:o,<i l"'t 

demonstrating the existence of dose: rate for ionizing radiation in 

the mouse model. Apparently. the status of the Genetics Fa net and 

the NAS was so high that no documentation was needed 

ernments worldwide. to adopt their reo,mrnenda· tions.Asrecentlyno-tedby\ c~,\"311 '''· 1il'-" ,, ,sevenofthemembers 

of the highly prestigious NAS BEAR I Committee Genetics Panell!ad 

no research experience with the -elfe(;ts of ionizing radii:ttion on 

mutations. In fact. Crow. who had never published on the topic, 

made the decision on which estim.;1.tes to retain. ft is atsu ironic that 

bemeret and NeeJ. who were amongst the most appropriately 

experienced, did not contribute to the radiation rlsk estimates. 

Thus, the Vision that the tO.Uil.try was being guided by the most 

prestigi(lus and -experie-nced grouping of gene-ticists on the matter 

of radiation induced genetic damage was yet another myth to 

enhance acceptance of the LNT. 

9. LIVI! William Runcll and tile <lose rate d!allenge 

Within 2.5 years of the June, 1956 NAS BEAR l 

Science pubilcation, another Science publication wuuJd 

one or the basic: tenets of the BEAR I, Genetics P~nel's recommen~ 

dations. The paper was by William L Russell of the Oakridge Na~ 

tlonai Laboratory, also .a member of the NAS BEAR I Geneti<:s PaneL 

During june- and July of 1958 Rossell's group ( Ct!"1fWt'S(\ ,.'J '1 > J, 

made a miijor discovery, that dose~rate. not total dose, was the key 

predictor of ionizing: radiation induted mutation for mouse spermatogonia and om:ytes. The Oak Ridge group kept this break~ 

through discovery quiet, not presenting the findings at the 

International Genetics Congress in Burlington, VT in the middle <1f 

August RusseT! did share the findings with a New York times 

ionizing radi.., 

ation was not cumutative, the potential to 

yield a threshold, sugge-sting the ex1stence of DNA repair. a possibility that Altenburg sl1ared with Muller soon alter publlcation of In effect. Russell had dlscredlted the 

geneticist community. creating a major 

His strategy would be to pro.tOOte the .;u:ceptaoce of his 

while. at the same time, crt<lting an imptesslon of 

adhering ro the radiation geneticist rtl<ttttra. Russell did not want to 

be ostracized and marginalized fi'om his field by his ideological 

radiation geneticist peers. Russell had seen the dominating and 

whose paper Multer tried to prevent presented ,at an 

internationaJ genetics conference during the summer of 19S6. rn fact, Russell's supervisor, Alexander HoUaender, negotiated a follow 

up "rerondliation"" meeting between Neet and Muller 

1957) at Oakridge, essentially in the of 

responw tight rope until after after which RusseU would unleash a 

the radiation genetics mantra and 

c), 

Despite these findings, their massive expansion by Russell and 

their powerful challenge to the lNT single .. hit reoommendatlon of 

BEAR I, it would take some 14 years before a new powerful Nl\S 

Committee, now :called the BElR I Committee with the Genetics 

Subcommittee being chaired by Muller's protegE jim crow to 

reconside:r the LNT recommendations of BEAR t During this protess 

the BE!R t Genetics Subcommittee re-examined the BEAR I 

a in denying 

rather than the total dose 

that the rad~tian 

damage with doSe replaced. This finding 

also meant that linearity may be at risk nf belng replaced by the 

threshold dose response. reversing the 1956 position of the BEAR J 

Genetics Panet Howover, despite these new challenges to the LNT 

model, the Genetics Subcommittee stiU had a strong disciple of 

Muller in charge with Crow/ and would find some rationale to keep 

the- Unear dose response model as the default if possible. 

Even though the findings of Russell revealed a true threshold for 

oocytes, the same couJQ not be said ror spermatogonia, where the 

dose-rate related damage, which was mediated by PNA repair, was 

only able to rctfuce total mutations induced acutely by 70% and not 

the 100% needed to ilchieve a threshold (h\W\' l ). The BEIR I Ge~ 

netics Subcommittee therefore concluded that even though It was 

now known that an ionizing radiation threshtlld existed for mouse 

~a roWani"th!,!:t!nd ofbl$ t..:Jtet"r, Q11w wOUldadctlowledge- !hat Mulkr and he were 

anwnpt the strm~ge:rt .tdwc.u-esuf'tNTand that they were tna extN~nte in their 

vi'M's:<ind AJ:fkJIU{'' ' IC '}. 
311 


33371.292

EJ. Cttlabrne 1 Enviromm:n.Mir>olllltion 241 (2Qt8} l8'9-3fJ2 

I 

f 

I 

I 

I 

I 

' I 

I 

I 

I 

I 

I 

I 

I 

o..b"' potalblo-dO!I!Heapom« 

CIJI'V(!Il ut lllgtl. dO! OS anD 

dn<>emtes 

llosc---

oocytes, the tNT woutd be based on responses of the mouse sper~ 

matogonia .. While this togk was convincing to the Genetics Subcommittee one would have to wonder why this didn't require 

further evaluation. Could there be an evolutionary explanation for why oocytes might show a threshold whlle spermatOgonia didn't? 

Oo oocytes have a more efficient DNA repair system than Sp€r~ 

matogonia? Are responses of reprodw.:tive celts directly applicctble 

to soma ti-e tells? 

noted questions or debated by 

the I Genetics Subcommitee. The is: that the Genetics Subcommittee failed to broadly consid-er the qUestion and 

were directed by the Crow leadership to obtain the <lesired 

outcome, Thus. Crow and his Genetics Subcommittee retained the 

tNT based on the non~threshold mutation <lata -of the mouse 

"homtng" device for the LNT model. In the late 1970. the U.S. EPA 

directly extended this linearity modet based on ionizing radiation 

to chemical carcinogens ( t,;;,,') The EPA linear cancer 

risk assessment policy would be in 2017 when 

had 

h), and had been .(Otrtcted for a 

massive error in by the Russells ( <, , 1 

calabres:e showed tbat if the corrected historical data had been 

used by the BEIR 1 {:'\·">.1<>\\H< Genetics Subcommittee the 

male mouse would hav-e shown a threshold while the female would 

show an hormetic response. These findings indicate that the basis 

for the lNT assumptiOn was incorrectly formulated and that the ddoption of tNT for risk assessment was incorrect 

10. Discussion 

ra-

::t''"m? e.xag.g:e":"r~ti,on~-~~~~~ 

their massive tNT-promotion 

BEAR I which affected 
312 


33371.293

£]. Cala!!rerv I i;)wfronmenrt~l Pc:lllltion :241 (J018J 289-302 

government, the scientific community, the media and the general 

public. 

Since the deceptions (e.g.. BEAR I) and significant errors (~.g., 

BE1R I) -can be traced back to major scientific historical figures. 

Nobel Prize winners (i.e. Hermann Muller. George Beadle and Max 

Delbru<k). prestigious US. NAS Committ~es (i.e. BEAR I and BEIR l) 

and at least one past NAS president (i.e. Detlev Bronk)(C.<.l\\1•·•" 

it is itnportant that the ideological history of cancel' 

risk assessment in the u.s. be documented -and become a part of the 

scientific and regulatory agency historical record to help ensure 

that vital pubUc health policies and practices do not continue to be 

the offspring of a sdentificaHy incorrect and dishonest past, 

This historic-al reveals a complicated dynamic: 

amongst researchers, colleagues, and rivals, all within a 

framework of politics, policies, social philosophies and personal~ 

!ties. Hermann Muller led the field, starting with redefining the 

concept of mutation and finding lmproved ways to assess it, Multer 

wqrked on these matters Within a framework of wanting to be first, 

gaining recognition and its benefits and pushing this to extremes. 

One example: -of this obsession is seen when Muller claimed credit 

for an important discovery (i.e .. first reported in Drosophila in whlcb 

both genetic and cytological evidence of translocation were combined) that Curt Stern had made dJt;l 

ttr;~!1 >}. Titis resulted in getting 

the nonnally reserved Stern to confront Muller via correspondence. 

Muller was forced to publitally apologize and correct the- matter, 

However; symptomatic of this behavior and in this .same general 

period,. Muller woutd apparently manipulate an editor at Science tO 

publish his discussion on X-ray tndttced mutation without 

providing any data. simply doing so as a means to ensure that he 

would be first - a tactic that was enormously rewarded. 

Much of what Muller dld over the next four derades was to 

and defend the legacy of his breakthrough gene tnuta· 

findings{lnterpretation and the formulation of the Proportionality Rule (the lNi ooncept).ln so doing, Muller would become 

the intellectual leader of the radiation genetic.'i community1 helping 

to cmmre its Importance and create new professional and funding 

opportunities, The principal challenge, for Muller was the 

thoughtful reflections of Stadler and his capacity t{} create and test 

key hypotheses, the data from which would challenge Multer's 

interpretation of his "groundbreaklog" 1i11dlngs. Stadler, who was 

unrelenting, objective a.nd insightful. seemed to follow in the 

footsteps of Muller's PhD. advisor TJi. Morg.an. TI1ese researchers, 

according to "~bhoTred what they termed "speculation", that they even distrusted the validity of the most essential 

lines of reasoning." Stadler and Morgan were leaders in that wave of 

skepticism whose participants "doubted the doubt 'tU they doubted 

it out." ('A\;11+': ',~JM, }. !n the end. Muller's interpret-ations were 

revealed via such follow up experimentation to be incorrect, that is, 

the very high doses he used produced heritable chromosomal, not 

gene. phenotype changes. More than so years later. with advances 

in nucleotide assessment methods, it would be shown that ionizing radiation could produce some gene mutations but at far lower dose-s 

Muller loyalists, such as Charlotte and others, 

would: strain the ltmits of credibility by .arguing that Muller was 

pyoven to ~ correct These examples of revisionist history were 

based Qn an incorrect Interpretation of his findings. Mtdfer would 

excite the world with the claim he produced 40 gene mutations one 

weekend .aftemoon. more than the entire field had produced in a decade Yet we now know that he was not producfng gene mutations. in fact, ~ ~>,·Ji:.~ would eventually 

support Stadler noting that "Stadler testt!<l many X-ray mutations of 

.a partictdar gene in maize and found that aU af them were deficiencies. Not long ago this conclusion was confirmed by experi· 

ments on a different gene in maze. Muller's evlde:nce, gain~d from 

work with Ororophila. was less direct '

1

f115}. While 

,\~v'tb,wh ~~r,~'ij\ gave the- proverbial to perspective. 

this was done even more emphatic any by two ve-ry dose colleagues 

and friends of Muller.\ , 1 'w? ': acknowledged 

that Stadler's de-le-tion interpretations had been convincingly sup ... 

pnne<l with mOdern analytical methods and that Muller was slm· 

p1y too stubborn. holding on too long to a discredited position. 

However. old deeply held and self-serving beliefs such as MoHer's 

original error of interpretation. would mesmerize the schmtifi:c 

community making it impossible to change. as it became an 

accepted myth leading ro the creation of the !.NT single-hit model 

for cancer risk assessment, affecting vast changes In public health 

risk assessment policies and risk communication strategies, while 

being susceptible to poUticat and ideological manipulation. 

The Muller story reveals a conflicted character, the discoverer of 

an apparent major breakthrough. s,omething that he gr-eatly 

desirt!<l. At the same tbne, Muller was tortured with the possibility that he was wrong:, spoke too soon. that his mutations were really 

only holes that the X-rays had poked in the chromosomes. He knew 

only too well that if his mutations were teal!y only poked holes 

there- really wasrft much new or :great with his "breakthrough" 

discovery. Thus, we have a life that sought to "hold on", while trying 

to prove that be actually had produced "real" mutations. 

Eventually the scientific story of Multer's chromosomal rather 

than gene mutations would progresstve.ly emerge, even if it would 

take up to five decades after he received his Nobel Prize.. The in ... 

fluence of Muller continues to be dominantly refle<ted in current 

regulato,y policy, which was based on poorly formulated science, in 

need of rom::ctive transformation by major agencies. such as the 

U.S. EPA. which however have been unable or unw'dllng ro do. TI1e: story of Muller's discovery of gene mutation also ~peaks t-o 

the, broader J:ssue of science being seif-corr«:ting:. Due to the 

cuurage and focus: of Stadler, MuUer's interpretations were mat ... 

Ienged and tested in the laboratory. This inspired others. including 

perhaps a Muller, t-o seek the trut11: These thaUeoges 

would be in the domains of cytogenetics. position effects, 

transpositional elements. reverse mutations, and eventually with 

the use of the Southern Blot, PCR and other DNA tech-nologies. We 

now know that Stadler was correct when he said that it was critital 

ror the scientific community not to confuse the observation of 

transgenerational phenotypic changes at high doses with its un~ 

known mechanism(s). fn the end, Mullet w.1-s eying in, 1927 to 

discover the mechanism of evolution. and he "knew" that itniust be 

gene- mutation. However, he convinced the world (at te.ast for a 

while), and maybe himself. that he had done so with his high dose 

Drosophila experimenh'ttton. However. th~ scientific community 

can thank Stadler and hiS collaborator McClintock for creating the 

necessary doubt that would eventually lead to science displaying a 

self~carrection for Muller's daim. An important follow up question 

is whether regulatory agency "'science". lUre that of experimental 

science, can be self-correcting. Now many years after Muller's 

·9-Jn~rivat\'!l~ttetswlthAltt'nEmrg(,\',,y,,,, q,;<'· ,.,,, 'r,\ ), 

Mutter would Acknowh:dge l)roblems With hl:S revenl" mutation explanatkm, the 

s:ignifitant rol~ of pQsitkm eff~ct .:~nd the influen~ of tbe. ll'IJJtable &mef of 

McCiinrock. 
313 


33371.294

E.,J. Ctriabre-st 1 Enviromnentaf Polluriml 241 (2.()18) 289-302 299 

incorrect interpretations were re~led. sodety stili lives: w!tb a 

risk assessment roodet based on a mistaken set nf MuHer's in~ 

terpretations. In 1995 crow would reflect upon the impact of his 

generation of radlation geneticists in estimating ionizing radiation 

induced risks. With his then 21l-20 hindsight Crow stated that 

Muller's readership and action ".Oversold the dangers, and should 

accept some blame tbr what to at least, tn be an 

irrational emphasis by the general some reguhtory 

agencies on low .. Jevel radiation In the aftermath of the BEIR I (1972) recommendation and Ute 

adoption of the LNT perspective fur regulatory .agency policy and 

practice came a spate ofbfostatistka1 models offering estimates of 

cancer risk in the low dose :zone following the linearized perspective. The broad range of linearized models were highly speculative 

attempts to estimate risks at very law dnses often using some feature of enhanced biological pt.ausihiHty, such as the number of 

theo.retkai -stages in cancer development. the role of interindi~ 

vidual variation, the incorporation of carctnogen bioact;ivation and 

DNA and other (<' J'to''';g:;-kt 

type of mod~ling the most part, In 

Mantel and P.ryan paper, based on the carcinogen 

contamination Cranberry stare during the Kennedy .. Nixon election 

of 1960 followed by a hiatus until the mid-1970s after the creation 

of EPA and OSHA when legislative and regulatoty activities intensified, These models were ronstrained by linear assumptions as 

provided by the BEAR I Genetics Panel, the llEIR I Committee and 

the official adoption ol LNT from UEIR I In 1975 by EPA {see 

recommendation to support the L.NT sing:te .. hit model by a su!J.. 

cQnunittee of the U.S. Department of Health & Welfare (\ h<< 

;:.1/ii)J. In betw'een these two NAS committees there were 

~dvisory groups of a national and tntemational nature that 

towed BEAR J (t>L.thP'M'> /tWiA). The linear ,assumption of these: models in the m.id-1970s and later were base4 on the predecessor NAS committees, with EElR 1 having the latest and most 

direct impact since it ms based on mke rather than fruit fly model 

of BSAR l. Given the above historical reconstruction, the risk 

assessment modeling acthtlties would have been considerably 

different had El'l\ determined thatthe default should be • threshold 

or hormetlc model 'the- rapid dominance of linear tancer risk assessment modeling :in the fate 1910s wuutd not have occurred without the recommendations of the tWO NAS committees. These 

modeling activities wer<t derived from biostatistidans who tried to 

derive mote biologicallY motivated Uilearized models, not being 

aware- of the plotting. scheming. misrepresentations 

.and mistakes of the two MAS In the end. the re~11 

leaders were MuUer. his radiation fuUo~rs and their 

institutional partners, The subsequent linearized modeling was simply the, foUowi~ of the linearity script as written by the NAS 

BEAR l Cenetic:s Panel. 

These convergent entities reached a type of critical mass during 

t11e MAS BEAR I Committee Genetics Panel. facltitatin,g no less than .a 

sctentifi<. social. psydtological and polltkall:r-based risk assessment revolution wnhin the U.S. and e-ssentially aU -other countries 

adopting the l.NT model fur cancer risk assessment 

11, CundU$IODS 

1. Muller incorrectly .assumed he induced getw mutations in 

1927 when he demtrnsttated that x~rays induced transphenotypic: changes in Drosophila 

2. The findings had a major impact au the sdentifk 

community. His non~peer~reviewed data 

and incorrect interpretations. were widely accepted ( 

o'm;)o 

3. This incorrect gene mutation me-chanistic interpretation lead 

to the development of the "Proportionality Rule" f.or dose 

response in 1930 by Mullet and the !.NT single-hit dose 

model 1935 by Timofeelf-Resrovs~ et al. 

thatcommunity, especially by j. 

McClintock. who showed that Muller's 

lnt<:tpt"etation Jacked scientific proof and 

5. Limited a conclusion 

that X~ray induced mut-ations were best explained by tot~l 

dose, not dose rate and the- genetic damage was cumulative, 

irreversible and the dose response was linear 

j<[,:j,:) 

U. Muller's total dose findings were strongly challenged in 

Manh.:attan ProjeCt research with far stronger studies 

(;, 1-;l)t t·\t\ ,{J' i) ,l}. These findings were improperly roarginw 

alized by leaders- of the U.S. r~diation genetics communities 

including Stem and Muller who misr-epresented the data via 

deceptions, fabe statements and obfuscations 

ina;~propriate awarding or the Nobel Pdte In 1946 to 

Muller producing "gene" mutations gave an enormous 

credibility to the LNT risk assessment model. facilita!ing its 

acceptance within the scientific, medical) regulatory and 

polltkal communities. It is likely that the award had long 

tasting: societal impact that facilitated worldwide acceptance 

ofLNT. 

,,_,,}in the 

late 1950s that responses mature spermatozoa to iOnizing radiation induced "ge:rte" mutation which were 

linear at high dose-s and independent of dose rate and such 

doses could be generalized to aU ceU types, doses and dose 

,). 

10. The NAS Genetics Panel deliberately misrepresented 

their own rese-arch findings and hid their contradit.:tory 

findings to promote the accept-ance of the tNT model for 

rcgu1atory agency risk assessment (t 

11. William L Russell at the Oak Rictge National Laboratory 

starting in Jate 1958 demonstrated that radiation 

induced mutations in mouse spennatogonia oocytes 

were dependent upon dose-f'-.Jtt!, not total dose as had been 

assumed, due to their cap.acity to repair DNA t1arnage 

). 

12, BEIR l (-",r'\> Genetics subcommittee 

acknowledged the "mistake" the NAS BEAR f Genetics 

Panel on dose-ra~ but still retained the LNT recommenda~ 

tion because the stgnfficant reduction in mutatton rate in the 

spermatogonia as shown by Russell e( af. had not regressod 

to control values as in oocyres. Nonetheless, the BE!R l Genetics Subcommittee suggested that findings from sper~ 

matogo.nia had greater capacity for gene-r~11ization to somatic cells, due ta tepalt t::apac:il;ie$c, as eomva~d to rnat\ire sper~ 

matozoa. Russe!l referred to failed DNA repair capadty as an 

"odd phenomenon. restrict~d to spe.:rmatozoa and 
314 


33371.295

JQO 

occasioned by the 

mato:wan ctll." ('. 

H. in 1995 a significa.nt error in the 

Russell mouse specific ltJcUS test historical control group, 

This error was subsequently acknowledged and corrected by 

\:'it~\~: along with :\l"tiP/ t ~~:"18,-,J>). tfthis 

not been made or had been corrected prior to the 

creation of BE!R I the mouse spermatogonia data that was 

used tu support continuance of the 00 model would have supported a. threshold o-r hormetic model on the 

Russell and Selby corrections, respectively 

genetics community, including 

Geneth:;s Panel and (5) failure to detect the error iil the 

Russett Mouse Specific locus 1'est: control group, which 

would have precluded support for LNT. EPA ttlen extended 

the error by adopting tNT for: cancer risk assessment,. stating 

in 1975 and 1977 that it was based on the now rec:ogni:t-ed 

erronequs dose rate findings: of Russell as dted in BE1R t 

(1972), 

15. lt is ironic that the misrepresentation of the scientific reoord 

by this NAS BEAR I Genetics Panel to prumote their ldeofogkat agenda stands in sharp contrast to the memorialized 

quote on the Einstein statute on the very grounds of the U.S.. 

NAS In Washington, DC It states: '"fhe right to search for 

truth implies also a duty: one must not conceai any part of 

what one has recogntted to he true." As the histoli<:al record 

shows the NAS BEAR I Genetics Panel did not fuUow the 

guidanc-e of Einstein. 

This work was supported by awards from the U.S. Nr 

Forte jFA9550-13-1-0047j and ExxonMobll foundation 

!S18200il00000256j. The US. 

duce and distribute for gov'ern,mental 

as necessarily representing policies or etl<lon;ement. 

expressed or implied. Sponsors had no involv-ement study 

design, cotlection, analysis, interpretation, writing and decision tn 

and where to submit for publication consideration. 

conflict of interest 

The- authors dedares no conflkt or interest. 

Declaration of interest 

None. 
315 


33371.296

£], Cato.br~ 1 Environmf"ntall'allution341 (20i8) 289-301 lOl 
316 


33371.297

30'l f.lc Culohuse 1 Enviromne-nml Polfmion 241 (2f}f8) 2w-JDZ 
317 


33371.298

Contents 1ists avaUabl~ at 

Environmental Research 

j-o-urnaf homt'.lpage: 

On the origins of the linear no-threshold (LNT) dogma by means of 

untruths, artful dodges and blind faith 

Edward J. Calabrese* 

Oepartment 1Jf E'fl\'frnliltftl:ltcl Hea1th Scienocs. Sthool of PuMk He!lith and Heilfrh Sdence.f. trniwrslty <l/ Manathus.ettr, Amiwm. MA. 0/003, USA 

ARTICLE lNFO 

Artickhistmy: 

R~eivtd ljune 2015 

kecelved in revised !"om1 

IGjuly20tS 

Accept~d 1i j\lly 2{)15 

Avaikblt online 4 Awust21lX?.,"-~~ 

treywordt: 

Rbk<ISS!'$$Jill'J'It 

DostHt.:splln!W.l 

Unt.atdru:eresporue 

Cancer 

Mutation 

lNT 

lon:illrtgradlatHm 

1. introduction 

ARST~ACT 

ln the course of recent assessments of the historical anrl sd· 

entifi:c fuundatioru or dose it was learned that 

the linear dose response promoted ro 

advance ideological most 

Collectively, these deceptive actions became highly 

significant when they facilitated an unchallenged and blind~faith 

adoption of the Linear Dose Response (LOR) model for cancer risk 

assessment of ionizing radiation and later of chemical cardnogens 

/m Sl>, adoption of the LDR model 

~ 2015 Elsevier Inc. All rights reserved. 

affet.:ted the magnitude of financial resources involved in reg~ 

t.datory actions, toxic tort decisions and medical it also 

~fkcted risk communication to 

has 

istic version of this complex story. In 

materials on key indiViduals have been and in~ 

rorporated herein to. darify p~vious histodcaJ frameworks. Finally. crit:kaJ feedback recentty received from reviewers, editors 

a:nd others in tbe research community bas proven invaluable in 

tempering the perspective and improving the content and <ontext 

of th.is assessment This paper follows an historical timeline, starting with the 

pro(ess.ionalfscientlfic relationship between Hermann MuUer and 

Curt Stern and their subsequent <;ollaboratlons -on ionizing radiation during the Manhattan Project. The ma;ny, and, at times, bizarr~ ways in which Stern tried to prevent .1ccepranc-e of the 

threshold modet supportive findings of Ernst Caspari. a member of 
318 


33371.299

the Manhattan Project team, in order to promote the LN't model. 

are detailed. Muller's Nobel Prize Lecture with his 

assessment of the nature of the dose response in range, especially in light of the Caspar! findings, is critiqued, 

leading to an assessment of bow he and Stem acted to cover up MuUer's Nobel Prize tetture deceit via obfuscation of the Man~ 

findings and the subsequent .state"" 

in the sc:ientitk The then as-,., 

valtdatlon and acceptance model. During this investigation, it became evident that the role of Hermann J. Multer 

was essential to the ,adoption of the lNT model and needed greater 

darlfication. 

in 

the "theory linear arran1:ement 

caily stated it in the title af the paper". '""' •cune<u>><n his 

to Muller with the .statement that !tis manuscript .. had been 

written before your [Muller's] first papers about them appeared." 

Nearly six weeks Jater, in .a letter dated October 3, 1929, Mullet 

would respond "1 am very sony to have omitted meotion or your 

work in my discussion of translocation and not to have given you 

credit for having made the first I'.Ytological demonstration of a 

geneticalty demonstrated translocation and pointed out its significance f<~r the theory of linear arrang-ement'". He then indicated 

that he had entlosed a "carbon copy of a note ! am sending in on the subject to th¢: American Naturalist. whith I llope will 

consider rectifying this mistake" ): , 

While Stern caught in a slgnifiCllnt prole"" slonal indiscretion, he let Muller •·control" the nan·ative by not 

objecting to MuUet1

S Vei'sioo of the correction. Nonetheles-s. this 

3. The Manbattan Proje<t: Curt Stem and !.NT 

partidpation in the 

ment proved to be extensive, 

rommunkations with Stern and other team membtts. visits to the 

of Rochester, and a donation of bis Mu!ler-5 strain of 

the Speru:er study. the effects of sex-linked re<:essive lethality 

term (?-40 min) exposures and a 

96 r/h. This resulted in a down ro 25 r (i.e .• 

21 days with sperm stored in sper~ 

Caspari study. there was an aging component to 

the sperm that was not in the Spencer study. The dose r-ate used in 

Caspari's study was much lower { 13,200 times that 

used in Spencer's a<.:ute study at the same 

The data from the chronic expt:tsure study of Caspari supported 

a threshold dose-response model. Stern initiallY rejected the 
319 


33371.300

434 

as seen in 

Caspa:ri's were unexpected and somewhat troubling to 

him because they challenged the linear paradigm of the radiation 

genetics oommunity. Therefure, Caspar! decided m send his findings to another leading researcher, Millsav Demerec. head of ge- netics at Cofd Spring Harbor; for re:vft>w and comment. Laspari was 

looking for a way around this (te,, alternative inter~ 

pretation) and hoping that the Demerec might offer a 

solution. Reflecting the bias of the radiation re~e;:,:rch 

~;ommunity at this time. Demerec wrote to Caspari, acknowledging the pmhlematlc nature of the data, and rather than 

rnmseff providing the hoped fur insight, asked Caspari what rould 

be done to .. save th& hit theory" (/\E1et;c;n Pl~Hti,K\}1l1KAl 'jnc·i;'t> 

'q:·o). There was little question that the Caspari data had created 

a problem and. in f~ct. it would be referred to by Stern as a 

"problem" in ruture corresponde-nce to Noviskl - (1\!T;\'ntc'\1; :;;'tn,'t\f tater become- a member the BEAR l Committee, Panel that 

recommended the acceptante of the Uneat dose--response modet 

While Stern seemed to accept Casparl's findings that supported 

the of his control data, he nonetheless challenged the in ways. The that Stern 

In the 

suppression ·~ enlllltl!:elt..int gamma 

male exposures and numerous - [see >1".'1 \r), making it virtually impossible (if not fmpractital} to re:sotve the differences. 

E.ven though the Caspari study adopted technical and metho~ 

dologka:l improvements over the Spence-r study and had .avoided 

serious operational errors of the Spencer study (e.g., Spencer's 

control ternn'''"''""'· hi:s combining of treatment groups 

but with dose that <!if· 

fered by up to 2.5 treatment 

gwups over the same tirne periods. and his inmnsistent calibra-- tion .of the X~ray machine. etc,) and errors in tile modellng of low 

dose responses (see dt:tailed critidsrns - {+lmt, "' ""' :m{" 

), It was strangely the Spencer Study 

its linear dose responst that became the gold standard .and not the c.,pari study. 

Discussion in the caspari paper, as noted above. made it de.ar 

that the findings in support of a !l\resbold should not he accepted 

until the differ~nces between the two papers ;:auld be resolved. As 

untenable as this position Stern's il:ctions Y~<ete even more 

inexplicable as he would nat a similar the 

flawed Spencer paper that supported linearity. 

unbean.t of,. for investigators w ask the sdentitic community not to 

accept the validity of their findings until it tol!ld be reliably de· 

termined why their findings <liffer~d fmm a study of considerably lesser quality and rell.abitity, Moreover, not placing at the 

same constraints on the weaker study, for which Stern was 

co*author, calls into question the investigator's non-biased <1-0d 

objective appro-ach to research. As a very accompHshed scientist. 

Stern shoutd have known that resolving differences between these 

two studies was not realistically possible. Stem's unusual behavior makes sense when viewed as i1n attempt to blunt any challenge to the linear dose-response model 

(te .. by demanding that the data ofCasparl not he accepted). Stem 

ensured the success of this by sen'Cilng the Spem:~r and 

caspari manuscripts his own Cenetics. and by fully 

controlting tbelr the disc:ussion. for an 

independent peer review as the papers were to the 

journal on November 25. 1941~ and published less rhan five ~ks 

later in january 1948 ("'' Ct~;t,,,,; <"" ,~ 

this point it was not dear whether Muller had seen the 

Caspari data prior to his Nobel Prize Lecture on December 12. 

1946. During th~ LectUre he disavowed any possibility th~t a 

threshold dose response could occur in the- induction ofmutatlons 

by ionizing radiation, Ht demanded a switch to the linear doser-esponse model. stating, "there is no estape from the conclusion 

that there is no threshcld" (,\A\tl\,,, lSl,+h,;}. Not knDwing whether 

Muller had seen Caspatl's data in support of • threshold model 

prior to his Nobcf Ptite lecture, several science- historians With 

considerable knowledge of Mulier and that era were then con~ 

tatted. Yet. none (}f these attempts answered the question, Fortunately. substantial oortespondente between Muller and Stern. Caspari, Spencer and ot11er~ was obtained from archlvaJ libraries. 

The archived ret:ords rev~.aled that Stem wrote to Multer on Sep- tember 24, 1946, to reques.t 1)is services in reviewing the Caspari 

manuscript in preparation for Journal submission. A follow-up letter from Muller on September 27. 1946, accepted this invitation 

and on November 6, 1946. Stern sent the manuscript to Muller at 

the University of Indiana. On Novernher 12, 1946. Muller acw 

knowledged receipt of both the letter and the manuscript. He also 

indicated that be had read manuscript and 

tWit the dose 

Muller's evaluation the taspari manuscript occurred five 

weeks after his Nobel Prize Lecture in the form of a detaUed letter to Stem da~d january 14. 1911 p,""W" 1~-,,, 

19,;' r), eased on this analysts, Mullet had not changed his-opinion. 

He uneqnivocally stated that b.e cotdd not find any meaningful 

criticism of Cas pari's: work (i.e., "l have so little to suggest in regard 

to the manusc:ript.") and he restated the need tn reptkate the 

findings (i.e., "Unfortunately. therefore a repUc;ation seiffilS to be 

imperative,"). lbus, the statements written in private by Muller tc 

Stem were those of a scientist, while his unequivocal public re~ 

jection of the threshold mod-el at the Nobel Prize Lecture was 

dereptive and not without ic:fuologkal und~rpinnings. Knowing 

that uncertainty ln low dose zone and that further 

study was needed. have acted 

pronouncing his conditional LNT modE"i ln Stockholm. Even four rermined steadfast and continued tn advocate his unqualified support f-or the linear do'SC-respqnse model. In a presentation to me New Y-Ork: 

Acadenw of Medicine in 1947, he stated that "there is. then absolutely no threshold dose ... and even the most minute dose carries a 
320 


33371.301

f.J C<!lalllrn' 1 Environmtllfal Rnearch 142 (2015) 432~2 435 

St'pttntbt'r 24t 1946"' Stem to Mtd1'er. 

"Dr, Cas-pari's. report on his work illiiOW lwlng typed and t wonder wh~th:erwt. 

could bothcr you with sending you a copy fur your new wmrue:nts." 

Sepwmh« 11, 1946 - Mlllter to Stan: 

~ Al$(1.,. rd bt' glad to sre Caspar!~ pd!}et WO. ~ 

Novern~ra. 1946- Stern to Mutter:: ~caspari'$ matm11tript hall lhwUy been typed and we would ;apprWatt very 

mU<h ~\11' Cfitk.ll re«<ilog of it." 

definite cll.ance of producing a change exactly proportional to thesize of the dose" (?v!i)kL \'+}J.;), 

Muller's statement jn a letter to Stem {AhH"n'~'~il 

about having "s:o little to suggest in regard 

Casparil manuscript"' may not have been truthful. as 

himself was most Hlcf'>ly responsibl-e the only two 

changes innoduc~d to- the paper prior to its submission to the 

journal Genetics. With the exception of tbese two changes, the 

published study in Genetics was identical in every way to that 

paper which was sent to both Muller fur his pre-submission re~ 

view ,a;nd to the 'Atomic Energy Commission (AEC) in 1947. ln the 

journal version, the first and most significant change was the de .. 

letion of a key sentence in the Conclusion of the 1941 AEC version 

' 'IJ4t ~ The deleted sentence is as foUpws:: 

the practical viewpoint, the results presented open up the 

possibility that a tolerance dose for radiation may be found, as fat 

as the production of mutadon is contcmed1

' (pag:e '15). This 

s.ratement indicated support for rhe threshold dose-response 

mode!. The second change was significant in that it added the 

name of Hel11lilnn J. MuHet to the Acknowledgme-nts uf thle' pub~ 

Iished paper. It seems more than just coinCidence that the only 

two changes hbparted to. the journal version consisted of (1} the 

deletion of a tonduding statement in support of a threshold dtrseresponse model and {2) the simult<tneous addition of Muller's 

name to- the acknowledgment section. There should be little do-ubt 

that removing the threshold conclusion statement was of profound benefit to Muller as it would help him su.snlin the ideofoM 

gtcal dominante of his fav-ored LNT modet Muller dearly had the 

means. motive and opportunity to mitigate the threat hnposW by 

Caspari's paper on the LNT model. So. wa.s Muller responsibll! for 

deleting the key concluding sentence in support of a threshold 

model? Well, we may never know for sure. but strong circumstantial evfdenc~ seems to point io that dlreetion, 

In the aftermath of the Nobel Lecture. Stern fultowed Muller's 

s:ugges:tian to repeat the findings of C.asp~ri. However. his two 

experienced doctoral researchers, Spence"r and Caspari. had lelt for 

the College of Wooster and Wesleyan University in Middleton, 

Connecticut. respectively. Consequently. Stern tJ.pp~ a. new 

Master's student. Delta Uphoff, a recent graduate of Rus.seU Sage 

New York, to replicate the Caspart research 

from her first experiment piqued Stern 

vaiue.s for mutation rates- were about 40% 

below those round in the literature, lnduding study. 

Stem expressed his concern to Mt.dler :and also MuUer tn 

share his largely unpublished data with him on among 

controls for the mutation rates of aging sperm in the fruit fly. ln a 

series of letters between Multer and Stern. Multer ronfl11Ttf;!'d that 

the findings of Uphoff were not reliable and that the unpUblished 

(and published) data were of the control resttl£S. Muller's data ted to an 

section of the Uphoff and Stern 

that the contrn1 

control group was most 

bias. Thus. in a rather unprecedented move, qukk to 

place blarnt"' on the- inexperiem."ed Uphoff. This manuscript, which 

importantly acknowledged the assistance of Muller. was sent to 

the Manhattan Project/AEC where it became 

!icJy unavailable. Thus. the acknowledgment by 

unreliable <ontroJ data. together with the letter exch-anges between Muller and Stern regarding the reUability of Caspari's con~ 

ttol data. indicated that Muller had strong confidence in 

not the Uphoff control data .-'\q;::), 

had Uphoff undertake a follow up replication study. 

a similar una001p!ably low control gmup refirst case~ the findings were again not interpretLtble. in a third experiment that was undertaken. an~ 

other problem arose. This time it was not the control group, which 

seemed to respond as expected, but the treatment gmup whose 

response far exceeded that predi<ted by a linear dose-respons<.' 

model. At tills point, Uphoff had finished her degree and eventhe National Institutes of Health (NIH) as a staff reHowever~ the- damage was done to the Stem initiative 

regarding the Manhattan Projecr/AEC. Each attempt to replicate 

the Caspar! findings had significant problems. Could anything be 

salvaged? 

In january of 1949, Stern deddrsi to submit a tC'chni.cal note to 

the journal Science, integrating the five m.:Qor experiments con~ 

ductl!d under direction for th~ Manhattan Project/ABC. Thes(' 

involved the of Spencer and Caspari and the three Uphoff 

replications. ln Science Stem attempted to rescue the 

first two he already knew had abettant 

l'\1<1/) and, according to milttiple 

Muller also knew. Stern also chose to 

that wen~ not in support of the Unear modei 

qh:'i} and, again attacked the Caspari study as 

aberrant even nothing had changed except for the r.x:currente of even more- do1ra supporting the reliability of Caspari's 

,_. 

Stem-Muller temtmral h~tter exthang" tol1ceming the ag-Cd .. sto.r.ed s:pe1111 eootrol 

mut:ation rate [tee({'/' 1\'\' '• 1i'q}- supplemetlt fOr a more romf)leit- Jeuer 

uch;mg:e}, 
321 


33371.302

EJ. Calablese I Envtl'tlllmi'nrlll Rese>!!rth 142 (2015} 432-442 

control group. These multiple flip·fiops by Stern were befuddling 

and surely required explanation, yet none were provided. The in~ 

ferior Spencer study continued to from 

both Srem and Muller even though, ~• veTJI 

significant problerm, none of which by in his 

letters to Stern tl\<! Sept~mber 13, 

1946 onjan· 

cause 

tide 

radiation" in the journal 

i 1

l9tr: provided an 

ings produced by {'.,1!\}1."1n on page 

10 "A recent paper b-y Spenc-er and Stem.~ .. extends the- principle 

(te., one-hit principle) down to total doses of SO r aru::125 r"". In the 

next paragraph, he states: "lt Is true, in paper .... Caspar\ 

and Stem hav~ reported results deviating from the 

above." In footnote 1 on p~e 10 o[the article cited a!mve, Mulier 

adds "Uphoff and Stern have published a report of further work, 

with doses as low as 50 r. given an intensity as low as 0.0165 r per 

minute. The results obtained are enttreJy in conformity with the 

one-hit of these results, together with 

the leads to the mnduston that tbe deviation first 

\:.fPrt' ~ iif<~<W findings) was caused by .a 

value for spontaneous mut.1tion rate that happened to be unusually high." Although this repeatedly false criticism by Muller was 

indeed highly disconcerting, other genetldsts seemed too wifling 

and ready to :accept more or less on •blind faith" and without 

proper review and If they bad thosen to follow the 

data from Muller himself{\h::,, and his own 1~)S2) as well J.!i 

perhaps the findings of 

caspar!. and not of Uphoff, reteived public attention 

and support. Thus, Muller continued to perpetuate a false view 

that was dis-credited by his own statements/data. Shamefully, 

there is no evidence that anyone chalienged Muller on these 

contradictions. Furthermore, Muller claimed that the research uf 

Delta Uphoff and Curt Stern was "entirely in tonfotmlty with the 

one-hit pdnc;iple* trunnl'c,,zy,, lh"YJHi'\kv' z"' l"i'S 1.}, Wbat Muller 

neglected to state wa.s that Uphoff's first two experiments displayed an aberrantly low control group responses based on Mul- ler's own extensive data involving some 200,000 fruit Hies ('V\lt ,, 

A letter from Curt Stem to Ernst c.,pari {fall 1947) 

addressed the rontrol 

group issue, tt states: "The radiation data continues t-o be puzzling. Delta's difference between control and exper{jmentat 

pears to be due 

yours.. HtJwever. 

control valve dose 

could be "explained 

happened to be 

t3'scontrol 

c-ontext of his 

ris-k asse~ment 

that would have been 

he made outing his Nobel 

A further ex•mple 

concept was in the Uphoff experiments 

0.00165 rjmtn. i.e., 50 r in or in 21 

;j}11}), Jn his paper entitled "Radiation 

netic Material" in the Amerlran Scientilt, !ndkated 

that their research extended "the principle of proportionality of mutation to doses down to doses of 50 rand 25 r and of less than 

0.001 t{mln with a time-intensity relation differing by over 

400,000 timt-:s frnrn that of our high intensity dose~·· By using the 

incorrect dos:e~r<~te or <Q001 r}min {instead of 0.00165 r/min) 

extended the Unear extrapolation over 400,000-

fold, some 150,000 ... fold greater than what the correct dose-rate 

would have predicted. just as in the case of validating the Uphoff 

control groups (discussed ahuve), no one cb>llenged Multer on this 

point lt is doubtful that Muilers actions was a simple editori>l· 

typo as Ir involved twa discrete changes, removing a 65 and 

adding a < sign. Furthermore, ~\60\t: had correctly dted 

the value as 0.00165 r[ruin in a previous paper. 

The a~tions of Multer and Stern {dted above} were critical in ptl'5Uading th-e radiation genetics community t{) adupt UN! tNT 

pt':r:spective, which was reinforced at multiple levels. By the early 

1950s, according to LNT had betome the dominant 
322 


33371.303

£.). CGfab.rt$1.! /.!:'nYfnmnumtul Researdl 142 (2:[)15) 432--442 

view or this group, dewtte having little: elsewhere. This 

timing is important ;~s it s-et the stage for actions of the NAS 

Genetics Panel on the Biologkal Effects of Atomic Radiation. which issul!<! its landmark report on June 1956, and published its 

tedmicai report in the joumal Science Fi'?-1>~1) later 

that month. 

Since- the nature of the do,-o;e response- in the low dose range 

was a critical issue, it would he important to know how the Ge~ 

netics Panel debated this issue, what the nature of the debate was. 

what votes were taken on the general dose respunse issues, and 

wbo were the leading participants In the discussions. The Genetics 

Panel met on November 20 .and 21, 1955, at Princeton 

February S and 5, 195G, In Chicago, Transcripts 

for both of these meetings, The Panel Md a fullow 

up meeting March 1, 1956, with partial attendance and only a 

summary {i.e., no transcript was taken). lntermeetlng 

con;tntmicatic•ns among Panel members were encouraged via the 

of working documents and draft materials, These comwere typically preserved in the historical record, and 

it was generally possible to obtain copies of papers and rorrespondences of the Panel members on BEAR l from their T~?spective 

institutional libraries. Although that which was archived varied 

ac-cording to each person; an effort w,as: made to obtain complete 

sets ofinformation on an Panel members. As a result c.opious fiti?s 

on P-anel members were obtained, enabling the reconstruction of 

Panel activity to a high degree. 

The transcripts of the Cenetlcs Panel indkate that the members 

adhered to the dose- re- sponse model. Sturtevant stated that he had ''no doubt about the 

correctness of the line~r dose re-sponse" and that any effort to 

further document support for it would be for the 

~:!1~~,:~;~~~:, needed to educate and ~o~:::~~~::~:i~~: 

Novemb~r 21, 1955, 

The Panel's single~mindt.-'tf uniformity of belief regarding the 

nature of the low-dose response was profoundly significant ,as lt 

tended not only to Urn it disc:uss!on .md preclude de hate but also to 

ensure adopti-on of their precQnce.ived notions. Due to this lack of 

discussion and absence of debate, the PaneJ was ~;hailenged to 

identify other activities that cauld productively fill its meeting 

times. The Panel Chair. Dr-. w.-.rren Weav~r of the Rockefeller 

Foundation, forged ahe.ld and challenged the 13 geneticists on the 

17~member Panel to ptovide estimates of genetic to the 

U.S. adult population given a specific exposure to the 

purpose of this exercise was to see how .closely estitmte.l of darn<ige might converge a blended mix of high 

!e:v-el expert genetidsts who had experiences studyiog 

an array of diverse populations, including n·ult flies. bacteria, 

par.:unecf11, :yeast, human popuJattons and dinkal patients. among' 

others. Weaver argued that a greater convergence {i.e .. agreement) 

among individual dat'I'Ulge estim<ttes would tend to yield a greater 

colllldence bY sOciety in the ·Panel's scientific conclusions and re- commendatiotlS. AftlloUgh one geneticist resigned from the Panet 

due to overriding academic commitments., the rt-mainlng 12 

For example, on 

"! use a.s a minimum estimate a extrapolat:ion from Drosophila and as a maximum some 

sex-ratio in the Japanese cities. An estimate 

from moulie: data turns out to be just about half way betweert 

so 1 shaU u5e it as the most probably esttmate.'1 The non~ 

biological reasoning demonstl'a_te how 

experts addressed this issue. As the 

geneticists similar lt':vels of uncertainty and dls~ 

agreement. it is nut surprising then that· the P•mel WCl.lld sllare 

their documentation with neither external reviewers nor the In~ 

t-eres.ted 

A problem arose as a result of the extreme variability 

among individual estimates. That the uncertainty of these 

estim<~tes would erode public in the Panel's pronouncements. Crow perceived the problem and memorialized bis 

concern in a fetter to Chairman Weaver of March 29, 1956: '71u;· 

limits presented on our estimates of genetic damagf!! are so wide 

that the reader wm. f believe. not have any confidence in them at 

all," Thus, Crow believed thi!t if the Panel shared its 

with the public then 

any scientific and 

Crow then made a 
323 


33371.304

438 EJ, catobn>se I Emrirttnmentol Rfi"earch 142 (2015) 432-442 

markedly reduced the: amount of variation within the group, this 

initial "a<ljustmenf' was slmply not enough to solve the variability 

problem. Crow then strongly Ufll<ld the Panel not to shdre the six 

remaining and highly variable with the s<ientific 

community and public. Tire Panel 

<:ommendation. and the majority sentiaUy eliminating anyone fr-om the 

science community from critically 

process hy which tlJese estimates were 

the voting tally was obtained. specific 

1ndMdual members wa..:;. diSt:<lvered for four 

their preserved corres;xmder,ce, 

to share 

The afOrementioned analysis reveals that the Genetics Panel 

deliberately falsified the research record in the Sctenu article by 

reporting that only six genetidsts provided estimates of radiation 

induced genetic damage. This was patently false as rune genet\dsts 

provided detailed estimates within the prescribed period of time. 

There was no expectation and no estab1i$hed protocol for the exclusion of estimates as each geneticist on the Pane! was considered 

an independent world-class e"l)ert in his own area of genetics, The 

person who excluded the three Crow. who lacked 

the authority to dO: so. the estimating ri:sk of 

5. BIWII Genetics Panel ceport - fallout 

Following its ads of falsificatio-n and fabrication o.f the research 

record, the Gencti<> Panel continued to shuw its tile 

aftermath of the BEAR l Panel and at the start of !I (fall, 

!956), In this case, several leading biologists had requested that 

the Genl'tics Panel provide documentation that would exp-lain{ 

support its decision to re-commend the adoption of the linear dose-respons-e model for risk assessment purposes, (('disiv,, 

~1-n t"1h) - Supplementary mate-ria! and F};,Jt ., The biologists 

nored that the !lEAR I Panel h>d proclaimed the correctness of the 

LNT model, bUt it failed to provide any wdtten scientific basis fur 

its decision. Since providing documentation to support major decisions is the main mission of any NAS Committee, the BEAR I 

Genetics Panel by this standard, dearly failed to perform its 

mission. However. in .a decision thilt may be difficult [O understand the to do so, deciding instead to redirt:ct its efforts to research areas for future funding, 

furthermore, it is hig:hty unust1a.l. if not astonishing, that the Panel 

a,~;:tuaUy informed the President of the NAS, Detlev Bronk that it 

had decide-d not to provide documentation to support the LNT 

recommendation. tn fact, no documentation in support or the LNT 

decision ever existed at the tlme of the BEliR ! Genetks Panel 

report on june 12~ 195-6, and now it would have to be written wen 

after the fact- a problem in and of ltseif, the 

Panel members. noted that they preferre"d to 

time Identifying fur funding OlliOOrl'unil:ies, 

some of which interest to their own rese-ardt laboratories, NO evidence been found to suggest that President 

Bronk ever to Paners no documentation decision, 

which him in a tetter from George Beadle, Chair 

of the BEAR Jl1 Genetlt:s Panel on September 11, 

1957. T~us. the President ol the the dedsioo 

oot to require the BEAR Genetics Panel to document its support of toe LNT model. 

The BEAR J and II Panels consisted of e$.'>entiaUy the same individuals except for two changes. The Chair (i.e., Warren Weaver) 

srepped down so he award from the Rockefeller 

Foundation to Panel an Qbvious conflict of interest • .and one n~w person {TG who had been invite-d for BEAR I, but was unavailable 

The BEAR l, Genetics P.ane-1 released their re-port .amongst a 

of media in the New \'ark 

'~*)·Other 

O!Otog.,><s.~uc:n inaot>r<><>ria'te actions 

it necessacy to fabricate and falsify in 

publication to ensure that their views Would be 

AU this W<ts clearly expressed in newly unearthe-d re~ 

of the Panel's correspondence. The of the Panel 

was nothing new as it was simply -eauying an 

decade -earlier by Hermann J. Muller at his Nobel Prize lecture. 

111e ex-plicit deceptions -of some Panel members continued even 

some after the fact. For example, Panel member .and genetkist Glass ;<nl), in a book review about the 

Rockefeller retold BEAR J, Genetics Panel story 

report-ed in the concerning how the Panel 

obtained its damage in the u.s. population. 

Glass wrote sought to ov-ercome vast dis~ 

agreements among Panelists by instrutting them to re-turn to their 

hotel rooms and work out their damage calcula.tions individually. 
324 


33371.305

The foUowing day. Glas:s reports, the dis.agrt"'etnents were pro.. 

roundly diminished and a strong <:onsensus emerged. The stal)l' by 

Glass tllaY wet! be how he remembered the event but his memory is strongty c-Ontradicted by the factual record. The fabrications of 

Glass started with his "authoritative" quote from Weaver th.at inspired the geneticists. to r~turn to their rooms. The quote does not 

exist in tb.e meeting transcripts. The story of Weaver sending Pa~ 

nelists: to their hotel rooms to work on their estimates and of their 

the next da.y in triumphal consensus likewise never 

ln fact, Weaver charged them to return tu their re- homes and gave them about a month to work on the 

Thus:, once b.Jsed on the transcripts and suir 

r.ommunkations. Glass bear$ false 

fabrication Is that t!re Panelists 

highly regarded Glass, among whose honors included 

being a President of the MAS and Phi Beta Kappa, amongst nu~ 

merous otber honors. repeated, tberefnre. the long established 

false narrative, reinforcing the tNT m<~ntra well into the modern 

era of risk assessment and doing so wlth great appeal to his au .. 

thority. This is therefore the stot-y of not only how the US. and 

world governments ca:me to adopt the linear dose response- fol' 

risk assessment but also how its origins were forged by deceptinn, 

artful dodges and blind faith to become established. pr~served, 

protected and reinforced by those very people (e.g. Genetics Panelists) and organizations (e.g. NAS} that sadetY ts suppo!'>f':d to 

trust 

6. The Ro<kefeller Foundation ond the tNT 

Jn 1954, tile Board of Trustees of the Rockefeller Foundation 

(RF) developed the proposition that it was n~cessary for the Uni~ 

r.ed States (U.S.) to undertake. a major ~ssessment of ionizing ra~ 

diatiun on humans and the environment. One of their Board 

members was Dr, Detlev Bronk, who was also serving at that time: 

as the President of the Rod<efeller Insn~ute for Medical ~ose>rch 

(which would be4"<Jltte Rockefeller University in 1955) and President of the US. National Academy of S<iences (NAS). Prior to this 

time, Or. Br<mk had also been the ~'resident of Johns Hopkins 

University and the President of the American Ass!Jdation far the 

Advancement of Science (MAS) in 19S2. Bronk took the proposal of the RF Board of Trustees to the NAS and received permission to 

Wldertake this ptoject as an official NAS activity {i \.AfnhHn, :~riff!'}. 

This new project was called the- NAS Biological Effects of Atomic 

Radiation (BEAR) Committee. The project involved six Independent technical panels for different areas of concern (e.g., 

genetics, pathology, oceanography and fisheries, agriculture, me~ 

teorology, and waste di~'Posal and dispersal). The paneb- were 

cteated by Dt. Bronk and administratively overst!cn by the R'F. 

All six Bl::AR Committee expert pan~ls were -ehaired by N!~ 

n.awned experts in their respective fields except [O:r the Genetics 

Panel, which was thatrerl by W>~rren Weaver, a mathematician and 

long-time admiolstratQr at the RF {Rc>:'>, 1\,f\ I'). Interestingly, Bronk 

selected Weaver to chair the Genetics Panel and, .as such, this sew 

lection represented a striking deviation in panel constructio"" and 

leadership, Although multiple im:!.ividuals with considerable re~ 

tevant scientific expertise and strong hMderShip skuts were Jlready on the GE>netic.s Panel, none of them would be selected as 

Chair. ove.rlooked in the setec:tion process were: George Beadle, 

t!\eluture l'tesident uf the Uni~~ersi!Jf of Chicago (ano 1958 Nobel 

Prize winner)~ Alexander Hollender, the highly regarded scientific 

admlnlstrat<Jr at Oak Ridge: Oarence c Little. the past President of 

439 

the Universities or Maine and Michig-an; and MiUs:t.w Oem-erec. 

Head of \.enetles at Cold Spring Harbor. In the selection of panel men\ hers, nne sta.;;pects that Bronk and 

weaver may have intended to "st'ttt."k the deck'~ radiation 

geneticists who support«~ the LNT. 

radiation geneticist at the Brookhaven 
325 


33371.306

440 E.j. Culubm'e ( fnvlroomenml Rne!.tfdl 142 (1015) 4:32-442 

Beadle, Dobzhansky, Muller and Demerec. In a tetter to Beadle, 

Demerec (JtrnN1csn llhihl$u;;illtdl t£)~~)'11) offered a fund~ 

ing plan that could be achieved by •setting aside a fUnd (let us say, 

one hundred mUllan dollars~ to Ire administered by some competent organiution (such as the National 

and U'<d during a period of 20 or 25 years to 

tianing research centers so as 

tists'. Dobchansl<y 

policy consequences. At an 

quire the panei to document the sde:ntitic for the tNT re~ 

c-ommendation and th.~ Panel members' s-elf-serving decision to 

identify funding oppertunitles instead 1:>f writing tb~ mgethet represent uns.crupuloos behaviors that enabled to 

establish the legitimacy of the !.NT model without having to 

defend their position and, at the same time, optimizing their furure funding options. 

? • Conclusions 

• The recommendation by the U.S. NAS in 1956 to adopt the !Nl' 

model was accepted by governments worldwide and 

provided the estimating cancer risks from ionizing 

radiation and over the past six dl!'cades. 

• The recommendations of the NAS BEAR I COmmittee, Genetics Panel were ideologically-driven with no- written scientific 

basiS provided by the Panei.The Genetics Panel explicitly refused 

to provide a written documentation when formally challenged 

to explain their Moreover. the President of 

the NAS became ln the Panel's questionable and irregular ill:tion.s: by no corrective action, even after receiving notification by of the Panel's refusal to provide 

such a re-port. • Studies under the direction of Curt Stem at the University of 

Rochester/University of CaHfomia~Berkley using Drosophila 

provided the sctentifir basis for the LNT of the llEAR l Genetics 

Panel. Detalle:d re--analyses of these studies has reve.ated se-rious 

flaws in the acute study by Warren Spencer and ln key follow up 

chronic exposure experiments by Delta Uphoff, Cmt Stem in· 

tentlonally concealed critical limitations of the Uphoff findings 

which had Stem and Uphoff characterize the"' findings as 

"uninterpretable"'. smrn, in cooperation with Hermann Muller, 

deliberately misrepresented and marginalized the findings of 

Ernst Caspari which supported a threshold modeL 

• The NAS Genetics Panel mmmltted scientific misconduct by 

falsifying, fahriC<~ting and then publishing in the journal Science 

its doctored estimates of human genetic risk: to radiation exposures. The Panel's deceits were designed to prevent the sci~ 

entific community- and the general public From knowing the 

profound uncertainties entailed in its genetit risk estimates. 

thereby insuring: the ready acceptance of its policy 

recommendations. 

communkation messages. ·rne implications actions are profound and 

likely to affect: human health risk assessment, adoption and use 

of new technologies, cost benefit assessments at multiple sod~ 

etaJ levels. roxie tort actions/decisions. and in the education of 

the public on vast areas or environmental health and medical 

tre.atment practices. 

Funding sources 

Resean:b activities in th¢ area of dOse respoll:se have bee-n 

funded by tfu! United St~tes Air Force and ExxonMobil Foundation 

ovtor a number of ye~rs. However, sudt fundlng support has nut 

boon used for the Prt'!sent manuscript. 

Anll'ffe'lll PhilosOph feat Soc~, 1929;t Ste:m letter ro MuHer. August B, i929. Arlll!tian Phllosophi!:ai Sod.ety, 192gb. Muller !ettt:t to Stt!m, October 3, l92-9. Anwrtcatt PhlltlSOPhlca! Sotk!ty, rn-Z!k. Stem lette-r 1:0 Muller, Octnber 21. 1929, 
326 


33371.307

441 
327 


33371.308

.. , £], Caklb~ I Errvlromnenflli Resel.lrt'h 142 (20lS} 432-442 

\ ' ' \{]:10 ~ 

Uphoff. 0£. Stem, C. 1941. hilluene.~ of 24~tmur giimma~ray lrradiatiCtl at !I)W 

dosa~ on !he mutation ratt In Orll1Qphlfa, MDOC-1492, U.S./\ttttnk Energy 

Comml!i:Sion, Hathl Trust Digital library, pp. 1-6, J\Vi!i:labJ~ at:{',-' 

''"'). 

htr ~·,·q,; ~:,en ,,;,>. Wynchank. S., 20tt nw Rotkerelit:t Foundation and its Support of Radiobiology \.Ill 

to tho ts'TO:o. Rockefeller 1\rt:blve Center, Research Reports. Onllne. {:· ,, 
328 


33371.309

Toxicology rethinks its central belief 

abandoned hazardous waste. 

being the foremost exnmpte in many minds, 

Likewise, debates rage about 'sa:fe' 1evels 

of oompounds:in the body, forexamplc leadassodated cognl:ti~ deficits in children, 

which are claimed to occur ;H blood lead 

levels lower than previously thought. In 

addition, the US Congress Is exploring whether low doses of organic: mercury 

preservattwsarecontl'tbuting to-an apparent 

t:narkOO increase in childhood autism. 

1hese, and numerous ather examples, 

illustrate the central role that toxicology 

and the knowledge of the d=-rcsponse 

relatlon.<hlp play in • vast amy of crltlcal env1ronmental1 medica! and public-health 

Issues, A< t"egulatory and public-health 

agencies base their decisions and pollr:i~ on 

toxirologtca( predictions, they are therefore 

of ronsfderable Importance to vast numbers 

1 of{X!Opleas-wclla,_tonatlona.leconomies. Ilk believe the predtcttve model< that oil 

reguhtoryagendesusearebased onafaUacyln 

the toxlcoiogk>l models used to predict and 

fX!rapohtte dose responses from chemtcals. 

phannaceutlqh tmd phys.tcal stressor <:~gents. 

}l,,, we cla.-ify the basis of this tallucy and 

advocate a more predictive model that wm revolutlon!r.cpubUcattitudcstowardsri$k. 

The most fundmncntal coru ... -ept us.ed in tod~ 

cology tb deterrnine risk assessment and 

regulation is the dose~response relationship, for whlclt two model$ have tradUionally 

b"'JI used, Tire threshold mode! (Fig, J a) is 

used Jn the assessment of risks for nm'l .. car~ 

dnagens, and the linear non-threshold 

(LN1) mode! (F!g.lb) to extrapolate risks to 

very low doses of carcinogens. But we believe 

the most fundamental s!sspe of the d<>se 

\ response is neither threshold nor linear. but 

l U-shaped (Fig, !c), and hence both cummt 

models, espectally the linearity model, pro1 

vide less reHableestimatcsofJow .. do..wrisk. 

This U-shape ls commonly called 

hom1esis- where a modest stimullitiOn of 

response occurs at low doses and an 1uhibi., 

tlon of response occurs: at high ones1

, The 

stimulation is often (but not always) 

nbserved foJiowlng an inlUal inhibitory 

resporiSt', 'llppearlng to represent a modest 

Figure t llypotbetl:tal ~ttfVt.'Sd\~fd<:tlug (il) 

thrt!Shotd, (b) Ji.nearnon~thrfShold,and (t') 

h.onnetit:do...e-re.spt~ns~mcde-lsuslngcnnetr 

(rnmdteroftumour.sperll;nlmaf) M!: theendpolnt. 

Thendudionln nwuberoftumour.s perardmal 

atthelo\'!fflrdo,o;es. (1-G) wmpand rot he number 

nftt:&n:ldiu'S;perarttroa-1 {5 huttour:t ~ranftnlll} fn 

the control indttah!1 a I'Edm·OO risk or e\ncer. 

overcompensation to a disruption In home~ 

astas~:e. Depent:Ung on the endpoint th-at is 

rneasuniD. the hormetic dose res.pome is 

either (ln inverted U -~the endpoints being 

gl'owth (such as the effects of low dO.')ei of 

various toxic metals, herbieides ilJld radiation on plant growth) or surviVal {such as 

the -effects of low do~Ws of gamma rays OTl 

rodents) - or a J-the end~ 

eomtder only 

threshold and linear models. 

The toxicologkal <-'Ormnunity made an 

error of histone proportions: In Its formative 

years (the 1930-40s}tnbuylnglntothethmh· 

old medcl', Onceae<:llpted.thlsmede!be<:ll!11e 

tlw bas~ for 

NATUREIVOL4llJ!3F~HRlJARYZ00'3!wwwJ~<ll'1<.;'0111fmlh!nt (Q 2003 NnturePubllshlngGroup 

dioxins, cadmium, mercury, numerousinsecUcldesih<ll'blcldcs, and numerous pharma· 

ceutital agents. These une:xpected. results were 

generally written offcttherasrepmduclblehut 

'parndoxicar phenOON!!JI! with no apparent 

capacity for generaUr..ation. or as biologlcaUy 

imtevantrandmn variation. 

The implications: o-fthfs ~)'Stnmatic error 

are immense, not !<Jast ln t1>x!Cologlca! risk 

assessment The • we devei· 

oped to assess 

diSplayed ev!dcnoe of on 

study design. magnitude of the sUmulat<>ry 

statlstlea! <>f the 

polycyclic: 3fQmatlc X-rays I and various gamma-roy sources reduce 

tumours in some species. Low doses of 

X~rays enhance life span ln male and ferrn:~-le 

mice and guinea piss; ethanol and acetaldehyde enhance longevity in fruit Oies; multi· 

pie s.tre.'iSOr agents extend Jongevity in 

nematodes; numerotts toxic substances (for 

example~ cadmium and lead) enhance 

growth in various plnnt species. Low or 

modest consumption of ethanol redtlees 

totalmortalityinhumans, whiJe1ncrea•;:ing U 

at higher levels ofeonsumpUon. The horrne~ 

sts concept is thus highly generalizable and 

far-reaching, 

Yet the vast majority of toxkological 

experJmerusare not designed to evaluate tho 

hormetlchypothesis,asses.,;;Jng dOSe..'l tluuare 

toe high for the hormetlt. dornaln. Of those 

expm·imcnts that do have study 

designs. a substantial demon~ 

stral:es hormesls. with 

rigorous and dearly entry and 

evaluativecriteria,thehormetlcmodelstrlk~ 

ingly outperforms the 'don'dnant' threshold 

modei1.. The hermetic mod~l is not an 

exccp.tkmtotherule- iUstheruJe. 

fundamental tenet, dose 

response, so wrong? is that, -as 

mentioned above. mosttoxkologlcalexperi~ 

ments tack the capacity to assess. possible 

ho-rmeticdoseresponses. Yetevenwhenthey 

do hove potentially adequate study designs, tM hormctJc ~pon.'in -can $till 00 mbsed 

because at the assumed toXltologlca! thresh· 

old d= (<llllcd NOA!lL, for no oh<ervect 

adverse effect level), there is oftP.n evidtmcc 

091 
329 


33371.310

of a low degrne of tmdclty, even If the 

is nor significantly different from 

control groul' A> the dose below tltc 

standard threshold becomes progre..sively 

more dilute, the response becomes more 

likely ro ~ the control value (hormctlc· 

like), This is why mammalian tox!col.ogical 

studies, which emphasize hlg!l-dosc toxlcu· 

log!call'll£ponsessuch as those u.•ed to assess 

possibletarctnogensin the US,Nat.ionatTox~ 

1m logy Program (NT!'), are oft<'.n Incapable 

o! adequately ass<!SS!ng the bormellc phe· 

nornenon, We.beUeve that this eombtoauo-n 

of ctrcumstaru:es contributed Significantly to 

thetro<lcologicaleommunlcy<mr!oo!tlog the 

honnetic mO<lel and puttl!tg fuUemp!tasJson 

the threshold model for non·cardnogl111S 

.andtheltnearmodt!:lforcarclnoaens, 

The mechanism which hormesiS 

••z 

dostt respon5e. the. F.PA could use the 

hormetic model as default to assess risk in 

both non,..tal"dnogensand can:lnogemll. 

The bormctli; pesspecUvc also turns 

upstde down the strate.gi('s and tactics used 

ror rtsk c::ommunkation of to-xit substances 

!nr tlte public'. For the pas!30 years, regula· 

tory and/or publtc-h~mlth agencies: in many 

countries have 'educated' - and in the 

process frightened tlw public to •xpect 

that there may be no safe expost1re level to 

many tolclc agents, epectally carcinogens 

sucha.'\radla.Uonand dloxtns, {ft!Y.thorrn.etic 

we:rc accepk.>d, the risk-assess~ 

would have to chauge 

F.xen::ise b: now being seen as a sisnilar 

phe.nomenon, in that there may be an optl~ 

mizcd degree of exerdse that ronfurs a Wide 

range of benefits, whereas a.t higher levels 

{dose), the net result would be Adwrse. 

Immunology is likewtscreplelewithexamples 

¢f both chemical· and rO<liatlon·lnduced 

hormetic·Uke biphasic dose rosponscs for a 

broad spectrum of rutdpoints and b!ologl<~l 

model:~, More than 150 endogenous aga~ 

ntstl., drugs and pollutants induce hormctlc 

etf~ts in hun1ans and other a:rtim<!ls, aff-ecting antibody prodttctlon, celi rnlg.ratlan, 

phAgocytosis of microbes, destruction of 

tumour cells and other end~ points. A better 

understanding of such phenomenon would 

have important irnplicaUons fur futmc 

researcha.ndbiornedlcalde:ve1opmcmt 

®- m~ NaturoPubUstllng Group NAlUREjVOL47.1 !UFERRUARY2003fwww fl~lln> ~m/1)8\llf11 
330 

Senator ROUNDS. Senator Ernst. 

Senator ERNST. Thank you to our witnesses today, and thanks 

for holding the hearing, Mr. Chair. 

Mr. Hahn, in your written testimony you stated that your research found that some of the EPA’s environmental assessments 

were not always of high quality, and these assessments went on to 

form the basis for major regulations. 

Can you go into a little bit more detail on this or specify which 

regulations you found to be based on low quality environmental assessments? 

Mr. HAHN. So, I did that research about 10 years ago, and I can’t 

give you a list of a top 10, and journalists often ask me, but I can 

give you some examples of what the problems were. 

Senator ERNST. OK. That would be helpful. 

Mr. HAHN. And some of these problems have been fixed. But you 

get a 200-page regulatory impact assessment, which is great for insomnia, on some chemical, and frequently the Agency doesn’t summarize in a very clear way what their main findings are; they don’t 

necessarily pay attention to the alternatives which they were supposed to think about in finding the best and cheapest way of 

achieving the result; they don’t necessarily count all the benefits 

they should have. 

So, there were real deficiencies in the analytical rigor that was 

underlying these regulatory proposals. And some of the administrators at EPA and other agencies have tried to fix some of these 

things; I don’t know how well they are doing. 

But what I would say generally—and I am sorry Senator Booker 

had to leave—I think it is a really good idea to be able to share 

data and models, because even at the highest level of academia, 

even with peer reviewed publications there are frequently errors. 

A couple of professors from Harvard, who shall remain nameless 

but everyone knows who they are, wrote a very influential book 

about how long it should take to recover after the last Great Recession, and it turns out there were some fundamental errors in their 

analysis that wouldn’t have been uncovered but for the fact that 

their data was shared, which is a good idea. So, I think it is a really good idea to be thinking about sharing data. 

At the same time, I agree with you that we don’t want to necessarily eliminate, by law or regulation, some very persuasive data 

that is published in peer reviewed journals, but my bugaboo is it 

is really important to share this data so other people can take a 

look at it in sunlight so that, when you are passing a regulation 

that is going to impose costs on people or make them lose their job, 

that you have the best available evidence upon which to make 

those decisions. 

Senator ERNST. No, I thank you for that. 

So, just going back and maybe repeating in different terms some 

of what you just said, it is possible, then, that some of those assessments were made, and they were the result of maybe shoddy work 

or perhaps errors; is that correct? 

Mr. HAHN. To use a phrase that my 3 year old niece used many 

years ago when I was doing this research, some of it was stinky. 

331 

Senator ERNST. Well, that is a great way to describe it. Do you 

think that the EPA was trying to tailor the assessments to support 

the need for regulations in some of those cases, perhaps? 

Mr. HAHN. I think it is possible. It is something that is very hard 

to prove, but we all live in Washington, DC. 

Senator ERNST. Certainly. And that is why I think that having 

transparency and peer review is important; a little bit of sunlight 

there. If a regulation is truly needed, then you shouldn’t be opposed to having other people take a look at the methodology there. 

Dr. Holt, this ties into this conversation as well. Some of those 

regulations turned out by various Federal agencies, including EPA, 

do pose economic threats to certain industries, and of course, a 

number of those communities that rely on those industries. If you 

were to be an employee of one of those industries or live in a community where a lot of that economic thrust is involved, shouldn’t 

you want to know every bit of information or data that is being 

used by those different agencies to develop the regulation that 

might threaten your very job or even your entire community? 

Mr. HOLT. Surely, there are regulations that don’t work well, 

that are improper, that even should be removed, but the approach 

to making regulations is not to limit bad regulations by limiting 

the science that might lead to regulations, which is what is going 

on here. The full science should be available. And this is not to 

make science more available; the effect is to restrict the science 

that is available, because the whole rule is about removing some 

studies that cannot be used to make regulations. So, we should ask, 

are we throwing out some good science here. And the answer that 

is arrived at by science society after science society, science after 

scientist, is yes, it would be throwing out good research. 

Senator ERNST. Well, I certainly appreciate all of the different 

opinions here today. 

Thank you, Mr. Chair. 

Senator ROUNDS. Thank you. 

Senator Whitehouse. 

Senator WHITEHOUSE. Thank you, Chairman. I appreciate this 

hearing. 

Dr. Holt, in a circumstance in which science discovers that a substance or a chemical is harmful to human health, and there is an 

industry involved in the manufacture or the distribution of that 

chemical or substance, and that industry wants to fight back 

against the science, what sort of an apparatus does such an industry have at its disposal to take on the enterprise of science? 

Mr. HOLT. Well, let me stick to the subject at hand here. An approach that they might use is to say that their test results are proprietary. And under this rule, if it were in effect, the studies that 

might be available would not be available because they have a legitimate claim to keep their data proprietary, non-public; and 

therefore, some good science that had been verified in appropriate 

ways would not be available to the regulatory agency. 

Senator WHITEHOUSE. Setting aside that question for a minute 

and back to my original question, does an industry in that predicament have access to an array of groups that have experience in trying to deprecate science and foment alternative views? 

332 

Mr. HOLT. Well, as I have heard you speak often, there is an imbalance in access to resources, access to media, and access to public 

persuasion, so the regulatory agencies are set up in order to try to 

restore that imbalance, to make sure that all parties have input to 

the regulatory process. 

Senator WHITEHOUSE. The concern or a concern that I have 

about the very title of this hearing, Sound and Transparent 

Science—which in theory is a very good thing—goes back to a 

phrase that has been kicked around in this conversation called secret science, which I think is a highly misleading term. My understanding is that very often in public health, in order to get data, 

you look at people’s public health records; you look at who got sick, 

who didn’t. You look at the health records of human beings. 

The condition of getting access to those records is that you don’t 

give that private information out publicly. People’s families might 

not want to know about it; people might not want their employers 

to know about it. There might even be cases where they don’t want 

their insurance companies to know about it. 

Will you agree with me that it should not be the price of having 

health records form the basis for scientific study that the individuals involved lose all their privacy with respect to their health 

records? 

Mr. HOLT. Still directed at me? 

Senator WHITEHOUSE. Yes. 

Mr. HOLT. Yes. You are right. As I said earlier, there really is 

no secret science. There should be fully available science when it 

comes to making regulation, and that science—— 

Senator WHITEHOUSE. And the term ‘‘secret’’ really—— 

Mr. HOLT [continuing]. That science is not just the data. Some 

of the data must be kept non-public because of health records, because of legal proprietary information, because of a number of 

other things. 

Senator WHITEHOUSE. But if you were an industry—— 

Mr. HOLT. But the science itself, the process of taking those data 

and verifying them should not be secret. But that is not what this 

rule or this legislation would deal with. 

Senator WHITEHOUSE. If you were an industry that wanted strategically to knock down public health science so that the dangers 

of your product were not understood or made public, then this 

would be a pretty handy way to go about it, because you disable 

an entire field of legitimate public health science by calling secret 

science science that actually only depends on people’s health 

records. 

Mr. HOLT. I think it could be used that way. 

Senator WHITEHOUSE. May I ask unanimous consent that a curriculum vitae for Dr. Calabrese dated August 2013 be put into the 

record? I don’t know if it is in the record already, but it is a pretty 

good summary of some of his industry clients and how much they 

have paid him over the years, and I think that is important in 

judging the witness’s conflicts of interest here. So, if I could add 

that to the record. 

Senator ROUNDS. Without objection. 

Senator WHITEHOUSE. Thank you. 

[The referenced information follows:] 

333 


33371.311

EDWARD J. CALABRESE, PH.D. 

CURRICULUM VITAE 

August, 2013 
334 


33371.312

TABLE OF CONTENTS 

I. SUMMARY....................................................................... 3 

II. BIOGRAPHICAL SKETCH................................................... 3 

III ACADEMIC TRAlNTNG...................................................... 5 

IV. WORK EXPERIENCE........................................................ 5 

V. GRANTS AND RESEARCH FUNDING..................................... 6 

VI. CONSULTING ACTIVITY (partial listing)...................................... 17 

VII. ACADEMIC AND OTHER HONORS.................................... 26 

VIII. SOCIETIES..................................................................... 27 

IX. UNIVERSITY ASSIGNMENTS................................................. 27 

X. CERTIFICATION................................................................... 27 

XI. VISITING PROFESSORSHIP.................................................. 28 

XII. PUBLICATIONS............................................................... 28 

XIII. PRESENTATIONS AT MAJOR 

CONFERENCES/INVITED SEMINARS.................. 88 

XIV. BOOKS.......................................................................... 140 

XV. CONFERENCE PROCEEDINGS- EDITORSHIP......................... 142 

XVI. NEWSPAPER COLUMNIST................................................... 145 

XVII. NEWSLETTER................................................................... 145 

2 
335 


33371.313

I. SUMMARY: 

• Professor ofToxicology at the University of Massachusetts, Amherst since 1976. 

• Board Certified in general toxicology by the Academy of Toxicological Sciences since 

1982. 

• Over 750 publications in peer-reviewed journals. 

• Over 600 invited presentations at major conferences and University seminars. 

• Author or Co-Author of26 hooks. 

• Editor or Co-Editor of over 40 monographs and/or conference proceedings. 

• Consultant to most environmentally oriented federal agencies. 

• Consultant to numerous major U.S. corporations and trade associations. 

• Extramural funding since 1976 from all sources exceeds 30 million dollars. 

• Founding Editor-in-Chief Human and Ecological Risk Assessment 

• Founding Editor-in-Chief Dose-Response Journal 

• Honorary Doctor of Science Degree, McMaster University 2013 

• Advisory Board for the first graduate training program focused on hormetic mechanisms, 

Friedrich-Schiller-University, Jena, Germany 2011 to present 

II. BIOGRAPHICAL SKETCH: 

Edward J. Calabrese is a Professor of Toxicology at the University of Massachusetts, School of 

Public Health and Health Sciences, Amherst. Dr. Calabrese has researched extensively in the 

area of host factors affecting susceptibility to pollutants, and is the author of over 750 papers in 

scholarly journals, as well as more than l 0 books, including Principles of Animal Extrapolation; 

Nutrition and Environmental Health, Vols. I and II; Eeogenetics; Multiple Chemical Interaction; 

Air Toxics and Risk Assessment; and Biological Effects of Low Level Exposures to Chemical 

and Radiation. Along with Mark Mattson (NIH) he is a co-editor of the recently published book 

entitled Hormesis: A Revolution in Biology, Toxicology and Medicine. He has been a member 

of the U.S. National Academy of Sciences and NATO Countries Safe Drinking Water 

committees, and on the Board of Scientific Counselors for the Agency for Toxic Substances and 

Disease Registry (ATSDR). Dr. Calabrese also serves as Chairman of the Biological Effects of 

Low Level Exposures (BELLE) and as Director of the Northeast Regional Environmental Public 

Health Center at the University of Massachusetts. Dr. Calabrese was awarded the 2009 Marie 

Curie Prize for his body of work on hormesis. He is the recipient of the International Society for 

Cell Communication and Signaling-Springer award for 2010. He was awared an Honorary 

Dcotor of Science Degree from McMaster University in 2013. 

3 
336 


33371.314

Over the past 20 years Professor Calabrese has redirected his research to understanding the 

nature of the dose response in the low dose zone and underlying adaptive explanatory 

mechanisms. Of particular note is that this research bas led to important discoveries which 

indicate that the most fundamental dose response in toxicology and phannacology is the 

honnetic-biphasic dose response relationship. These observations are leading to a major 

transformation in improving drug discovery, development, and in the efficiency of the clinical 

trial, as well as the scientific foundations for risk assessment and environmental regulation for 

radiation and chemicals. 

4 
337 


33371.315

Name: Edward J. Calabrese 

Date of Birth: August10, 1946 

Ill. ACADEMIC TRAINING 

University of Massachusetts at 

Amherst,MA 

University of Massachusetts at 

Amherst,MA 

CURRICULUM VITAE 

Address: 60 Cherry Lane 

Amherst, MA 01002 

Phone: (413) 549-5264 (home) 

(413) 545-3164 (work) 

Fax: (413) 545-4692 (work) 

E-Mail: edwardc@schoolph.umass.edu 

1972-1974 Education Ed.D. 1974 

Science Ed. 

1971-1973 Physiology/ Ph.D. 1973 

Toxicology 

(Entomology Department) 

State College at Bridgewater, MA 1969-71 Biology M.A. 1972 

State College at Bridgewater, MA 1964-68 Biology B.A. 1968 

IV. WORK EXPERIENCE 

Graduate Program Director, Environmental Health Sciences Department, December 2003-2004. 

Division Chair, Environmental Health Sciences Division, December 2003-2006. 

Director- Northeast Regional Environmental Public Health Center, 

October 1985-Present. 

Professor· Promoted from Associate Professor, June 1982-Present. 

Associate Professor- Promoted from Assistant Professor, June 1980. 

Assistant Professor - September 1976 - Environmental Health Sciences Program, Division of 

Public Health, University of Massachusetts, Amherst, MA. Duties include: teaching 

introductory and advanced courses in environmental toxicology, directing thesis research. 

5 
338 


33371.316

Assistant Professor- July 1974-August 1976 - Department of Occupational and Environmental 

Medicine, University of Illinois, School of Public Health, and Assistant Director of the 

Environmental Health Resource Center. Duties included: the identification and quantification of 

present and potential environmental health hazards within the state, the development and review 

of environmental health legislation, standards and regulations, testimony at regulatory and 

legislative hearings on standards of environmental quality and teaching courses in environmental 

health. 

Environmental Research Director for the Massachusetts Public Interest 

Research Group- December I 973-June 1974. Duties included: determination of research and 

educationa 1 goals of the organization, direction of student research projects, direction of Water 

Quality Training Institutes throughout Massachusetts. 

Adjunct Professor- Southwest Residence College - University of 

Massachusetts. January 1974. Taught environmental science courses to undergraduate and 

graduate students. 

Assistant Professor- Fall 1973 - North Adams State College, North Adams, MA. Biology 

Department- taught Ecology, Evolution, and Introductory Biology. 

V. GRANTS AND RESEARCH FUNDING 

Principal Investigator. Air Force Office of Scientific Research. Enhancing Biological 

Performance: Occurrence, Mechanisms and Applications. 2013-2018. ($1,197,558). 

Principal Investigator. ExxonMobil. 1-lonnesis Research. 2007-2013. tS 150,000 per year). 

Director. Hormesis Conference general support. Multiple public and private organizations. 

2010-2013. (Approximately $50,000). 

Principal Investigator. Air Force Office of Scientific Research. Conference on Adaptive 

Responses and their Biomedical Applications. 20I2. ($25,544). 

Principal Investigator. Air Force Office of Scientific Research. Conference on Adaptive 

Responses and their Biomedical Applications. 20 II. ($25,580). 

Principal Investigator. Lounsbery Foundation. Development of an Integrative Mechanistic 

Framework. 20 I 0-2012. ($25,000) 

Principal Investigator. Air Force Office of Scientific Research. ChemicaVRadiation Hormesis 

Database, Evaluation ofHormetic Mechanisms & Their Biomedical and Risk Assessment 

Implications. 2008-2010. ($299,371). 

6 
339 


33371.317

Director. Honnesis Conference general support. Multiple public and private organizations. 

2008-2009. (Approximately $120,000). 

Principal Investigator. Air Force Office of Scientific Research. Chemical/Radiation Hormesis 

Database, Evaluation ofHormetic Mechanisms & Their Biomedical and Risk Assessment 

Implications. 2007. ($84,778). 

Principal Investigator. Air Force Office of Scientific Research. Chemical/Radiation Hormesis 

Database, Evaluation ofHormetic Mechanisms & Their Biomedical and Risk Assessment 

Implications. 2007. ($199,845). 

Director. Hormesis Conference general support. Multiple public and private organizations. 

2007. (Approximately $150,000). 

Director. Hormesis Conference general support. Multiple public and private organizations. 

2006. (Approximately $100,000). 

Principal Investigator. Alfred P. Sloan Foundation. Hormesis Center. 2004-2007. ($45,000). 

Principal Investigator. Dow Chemical Co. Distributions for Monte-Carlo Soil Ingestion Risk 

Assessment. 2004-2007. ($160,470). 

Principal Investigator. Lounsbery Foundation. Workshop to Create a Hormesis Institute/Center. 

2005-2007. ($75,000). 

l'rincipallnvcstigator. ExxonMobil. Honncsis Research. 2006. ($150,000). 

Principal Investigator. Air Force Office of Scientific Research. Chemical/Radiation Hormesis 

Database, Evaluation ofHormetic Mechanisms & Their Biomedical and Risk Assessment 

Implications. 2006. ($214,645). 

Principal Investigator. ExxonMobiL BELLE- Chemical Honncsis Database. 2005. 

($150.000). 

Principal Investigator. Air Force Office of Scientific Research. Chemical/Radiation Hormesis 

Database, Evaluation ofHormetic Mechanisms & Their Biomedical and Risk Assessment 

Implications. 2005. ($211,026). 

Principal Investigator. U.S. Department of Energy. International Conference- Honnesis 

Implications for Toxicology, Medicine, and Risk Assessment. 2005-2006. ($5,000). 

Principal Investigator. Dow Chemical Co. Distributions for Monte-Carlo Soil Ingestion Risk 

Assessment. 2004-2006. ($160,470). 

Principal Investigator. Alfred P. Sloan Foundation. Hormesis Center. 2004-2006. ($45,000). 

7 
340 


33371.318

Principal Investigator. U.S. Department of Energy. Non-Linear Dose Response Relationship in 

Biology, Toxicology and Medicine. 2004-2005. ($20,000). 

Principal Investigator. General Electric Foundation. BELLE Initiative. 2004. ($100,000). 

Principal investigator. Exxon Mobil. BELLE -Chemical Honnesis Database. 2004. l$75,000). 

Principal Investigator. Air Force Office of Scientific Research. Chemical/Radiation Hormesis 

Database, Evaluation of Hormetic Mechanisms & Their Biomedical and Risk Assessment 

Implications. 2004. ($174,302). 

Principal Investigator. U.S. Department of Energy. Non-Linear Dose Response Relationship in 

Biology, Toxicology and Medicine. 2003-2004. ($12,500). 

Principallnvestigator. Florida Power and Light. Assessment of Arsenic Bioavailability in 

Humans. 2002-2003. (-$110.000). 

Principal Investigator. Air Force. Toxicological Assessment of Hormesis. 2001-2003. 

($450,000). 

Principal Investigator. US EPNAmerican Chemical Council. Soil Ingestion in Construction 

Workers. 2001-2003. ($750,000). 

Co-Principal Investigator. Health Risks and Fish Consumption from the Pasiac River. 2001-

2002. ($125,000). 

Principal Investigator. CA EPA. Single Exposure Carcinogen Database Update and Evaluation. 

2002. ($50,000). 

Co-Director. II th Annual Soil and Groundwater Conference. San Diego, CA. March 2002. 

($100,000). 

Co-Director. 18th Annual Soil, Groundwater and Sediment Contamination Conference. 

University of Massachusetts. October 200 I. ($125,000). 

Principal Investigator. Conference on Non-Linear Dose-Response. Multiple sponsors (EPA, 

NIEHS, AWWARF, Air Force, and other). June 2001. ($150,000). 

Co-Director. International Conference on Contaminated Soil, Sediment, and Groundwater. 

London. August 2000. ($300,000). 

Co-Principal Investigator. Soil ingestion workshop/assessment. U.S. EPA. June/July 2000. 

($50,000). 

8 
341 


33371.319

Principal Investigator. Soil ingestion in construction workers. U.S. EPA/CMA. October, 1999 

($650,000). 

Principal Investigator. Development of an ionizing radiation hormesis database. Nuclear 

Regulatory Commission. September 1997 - September 1999 ($188,000). 

Principal Investigator. Biological effects of low level exposures. Three year cooperative 

agreement. Reviewed once, 1999. Nuclear Regulatory Commission, 1996-1998, 1999-200 I. 

($60,000 or $20,000/year). 

Principal Investigator. Assessment of soil ingestion in children. Health Canada. January 1999 

($6,500). 

Principal Investigator. Biological effects of low level exposures (BELLE). From multiple 

sponsors. 1997, 1998, 1999,2000,2001,2002,2003,2004. (approx. $120,000/year from 

multiple sources). 

Co-Principal Investigator. Florida Power and Light. Biological .:ffccts of arsenic contaminat.:d 

soil. January 1998 ($100,000). March 1999 ($50.000). 

Principal Investigator. ARCO. Assessment of the role of pm1icle size on soil ingestion estimates 

in children. June 1997 ($150,000). 

Principal Investigator. Health Research Foundation (Japan). Biological effects oflow level 

exposures. September 1997 ($15,000). 

Principal Investigator. U.S. Air Force. Assessment of the societal and scientific implications of 

horrnesis. October 1997- October 2000 ($345,000). 

Principal Investigator. U.S. EPA. Single exposure carcinogen database. October 1997- May 

1999 ($75,000). 

Principal Investigator. GE Foundation. Biological effects of low level exposures (BELLE). 

October 1997 ($15,000). 

Co-Principal Investigator. EPA. Assessment of groundwater contamination by MTBE. 

September 1997 ($43,000). 

Principal Investigator. Exxon. Biological etTects oflow h;vel exposures. 1996-1999 

$20,000/ycar. ($RO,OOO). 

Principal Investigator. Dow-Coming. Biological effects oflow level exposures. 1996-1999 

$1 0,000/year. ($40,000). 

9 
342 


33371.320

Principal investigator. Canadian Electric Utili tie~. Biological effects oflow level exposures. 

1996 ($10,000). 

Co-Director. Bitor-Vcnezuela. Evaluation ofthe endocrine disruption potential ofsurfactants. 

June 1996 ($447,000). 

Co-Principal Investigator. Massachusetts Department of Environmental Protection. 

Determination of heavy metal background levels. June 1996 ($23,000). 

Principal Investigator. ARCO. Assessment of the role of particle size on soil ingestion estimates 

in children. June !996 {$150,000). 

Principal Investigator. Radiation, Science and Health, Inc. Critical assessment of selected 

literature on radiation hormesis. December 1996 ($26,000). 

Principal Investigator. Environmental effects of Orimulsion. December 1996 ($836,000). 

Principal Investigator to support BELLE related activities. January 1995. RJReynolds, Inc., 

$25,000; Electric Power Research Institute, $1 0,000; Dow Coming, $1 0,000; and Canadian 

Electric Utilities, $10,000. 

Principal Investigator. RJRcynolds, Inc. The effects of low levels of chemical agents on 

biological responses. Fcbmary 1995 ($25.000). 

Pnncipallnvcstigator to assess soil ingestion in children living in Northwest of the U.S. ARCO. 

September 1992 -June, 1996 ($748,000). 

Principal Investigator. Louisiana DEQ. Assessment of soil ingestion in children. June 1995 

($50,000). 

Principal Investigator. US EPA. An evaluation of gender differences in susceptibility to toxic 

substances. June 1995 ($55,000). 

Principal Investigator. US EPA. Single exposure carcinogen database. October 1995 ($75,000). 

Principal Investigator. Health Canada. Develop new methodologies to assess human high risks. 

November 1994 ($60,000). 

Principal lnv.:stigator to dirl-ct BELLE activities. EPR I, Dow Coming, Center for Indoor 

Research, and EPA. October 1994 ($55.000). 

Principallnvestigator. Florida Power and Light. Development of a fmmework to conduct an 

ecological risk ass-:ssrncnt on Tampa Bay. April 1994 ($140,000). 

10 
343 


33371.321

Principal Investigator. Gillette, Inc. Support of BELLE-related activities. May 1994 ($3,000). 

Principal Investigator. Florida Power and Light. Assess the effects of several types of fuel oil 

on red blood cells. September 1994 ($31 ,000). 

Co-Director of a series of conferences on petroleum contaminated soil. Held at the University 

of Massachusetts, Amherst. 1985, 1987, 1988, 1989, 1990, 1991, 1992, 1993, 1994, 1995, 1996, 

1997, 1998, 1999, 2000,2001.2002. Approximately $100,000/conference from external cosponsors. 

Co-Director of a series of conferences on soil and groundwater contamination. Held in the 

greater Los Angeles area. 1989-2002. $1 00,000/year. 

Principal Investigator on a grant to assess interspecies differences in hepatic peroxisomes 

proliferation and its role in the development of fish tumors. Department of Defense, U.S.A. 

Aprill988-1993 ($749,000). 

Florida Power and Light. Critical Evaluation of the PM to standard. November 1993 ($20,00<1). 

Principal Investigator to direct BELLE activities: EPRI, Dow Coming, Center for Indoor 

Research, and others. Aprill993 (approx. $50,000). 

Principal Investigator to assess single exposure carcinogens. A TSDR/September 1993 

($50,000). 

Principal Investigator to assess the prevalence of soil pica in children and soil ingestion in 

children with soil pica. State ofColorado. July 1992 ($151,000). 

Principal Investigator to direct the development of a newsletter on the Biological Effects of Low 

Level Exposures (BELLE). U.S. EPA. September 1992 ($60,000). 

Director of the Council for Health and Environmental Safety of Soils Funded by EPA, ATSDR 

and other organizations. 1988 - 1992 ($150,000/yr.) 

Principal Investigator. U.S. EPA. Lead Training Center. March 1992 ($320,000); October 

1993 ($220,000); October 1994 ($290,000). 

Co-Director of National Conference on Hydrocarbon Contaminated Soils. From multiple 

agencies/organizations. ($70,000). 

Co-principal Investigator- Development of risk assessment methods for human and ecological 

risks. Health and Welfare Canada. April 1 1992 ($75,000). 

Co-principal Investigator for Regional Lead Training Center. U.S. EPA. Aprill992 ($250,000). 

11 
344 


33371.322

Principal Investigator to conduct national conference on the Biological Effects of Low Level 

Exposures to Chemicals and Radiation. NIEHS. April 1992 ($1 0,000). 

Principal Investigator to support research activities concerning the biological elfects of low level 

exposures (BELLE). Ontario Hydro. January-May 1992 ($20,000); RJR-Nabisco ($35,000); 

EPRI ($10.000). 

Principal Investigator to assess the effects of selected oxidant stressor contaminants on red blood 

cells. State of Colorado. May 1992 ($44,000). 

Principal Investigator to assess factors assessing the siting of waste sites in the U.S. Waste 

Management Inc. June 1992 ($200,000). 

Principal Investigator to assess environmental factors affecting stream health. Wyman-Gordon, 

Co. July 1992 ($135,000). 

Co-Director of the Hydrocarbon Contaminated Soil and Groundwater Conference. Newport 

Beach, California. 1991 -co-sponsorship $100,000 (approx.). 

Principal Investigator to unrestricted support on predictive toxicology. Proctor and Gamble. 

June 1991 ($5,000). 

Co-principal Investigator to develop a toxicological based risk communication program for lead 

in water. U.S. EPA. August 1991 ($50,000). 

Co-Director of the 6th Annual Hydrocarbon Conference. Sept. 1991 (combined sponsorship 

$100,000. From multiple agencies, federal, state and private sector). 

Principal Investigator of a project to differentiate soil and dust ingestion in children. U.S. EPA. 

Sept., 1991 ($50,000). 

Principal Investigator to support research activities concerning the biological effects of low level 

exposures (BELLE). Dow Chemical. November 1991 ($5,000). 

Principal Investigator to support research activities concerning the biological efleets of low level 

exposures. RJR Nabisco. Inc. July 1990 ($45.000). 

Principal Investigator-Evaluation of the health basis for EPA's regulations of SOTs and 10Cs in 

drinking water. American Water Works Association Research Foundation. July 1990 

($1 00,000). 

Principal1nvestigator on contract to assess the relative potency of methemoglobin fanning 

agents. EPA. July 1990 ($28,000). 

Principal Investigator-Methemoglobin fanning agents: Toxicologic and risk assessment. EPA. 

August 1990 ($28,000). 

12 
345 


33371.323

Principal Investigator to support research activities concerning the biological effects of low level 

exposures. Dow Chemical. November 1990 ($1 0,000). 

Principal Investigator to suppon research activities concerning the biological effects of low level 

exposures. The Electric Power Research Institute. December 1990 ($10,000). 

Co-Director of the Hydrocarbon Contaminated Soil and Groundwater Conference. Newport 

Beach, California. 1990- co-sponsorship $100,000 (approx.). 

Principal Investigator of a contract to assess the Public Health risks associated with medical 

waste. Funded by the Rockefeller Institute of Government, Albany, New York. January 1989 

($15,000). 

Co-Principal Investigator on a grant to assess factors affecting heavy metal tissue distribution in 

selected fish species. General Electric. July 1989 ($112,500). 

Co-Principal Investigator on a grant to assess public health aspects of soil contaminated with 

petroleum. U.S. EPA. July 1989 ($43,000). 

Principal Investigator to continue research on how to estimate how much soil children ingest. 

Gradient Corporation. August 1989 ($35,000). 

Director of a conference on drinking water and health. American Water Works Association 

Research Foundation. September 1989 ($1 0,000). 

Principal Investigator of a contract to assess the methodological approaches for establishing an 

Air Toxic Programs. Rohm and Haas, Inc. Part I -January 1987 ($60,0000. Part 2 -January 

1988 ($60,000). 

Principal Investigator on a grant to develop an approach for assessing human risk for soil 

contamination. Hercules Corporation. January 1988 ($1 0,000). 

Principal Investigator of a contract to assess environmental exposure from the application of 

lawn care chemical treatment practices. Massachusetts Department of Food and Agriculture. 

January 1987- June 1987 $75,000; July 1987- June 1988 ($75,000). 

Director on a grant rrom Proctor and Gamble in the general area of research in animal 

extrapolation. July 1988 ($5,000). 

Principal Investigator of a grant to assess the amount of soil children consume. Syntex, 

Corporation. August 1988 ($25,000). 

Principal Investigator of a study to assess the environmental and public health effects of soils 

contaminated with petroleum products including disposal options. Mass. Depart. of Environ. 

Engineering. July 1986 - June 1987 ($1 08,000). 

13 
346 


33371.324

Director of workshop on risk assessment for aerial spraying of insecticides for control of gypsy 

moths. U.S.D.A.- Forest Service. January 1986 ($12,000). 

Co-principal Investigator of a grant to assess the effects of acid rain on selected freshwater fish 

species. Massachusetts Fish & Wildlife Service. May 1986 ($7,000). 

Co-principallnvcstiglllm of a contract to assess the environmental and public health implications 

of disposal options for petroleum contaminated soil. Edison Electric Institute. July I \186 

(550.000). 

Co-principal Investigator to establish an aquatic toxicology research program in the School of 

Public Health. Funded by the Mass. Department of Fisheries and Wildlife. July 1986 

($1 00,000/year). 

Principal Investigator of a study to assess the environmental and public health effects of soils 

contaminated with petroleum products including disposal options. Mass. Depart. of Environ. 

Engineering. September 1984- June 1985 ($71,000). July 1985- June 1986 ($76,000). 

Director on a grant from Proctor and Gamble in the general area of research in animal 

extrapolation. August 1986 ($5,000), an additional $5,000.00 was received in July 1987. 

Principal Investigator of a grant to assess the amount of soil children consume. Syntex, 

Corporation. August 1986 ($344,000). 

Co-principallnvestigator of the 3-year grant to assess the aquatic toxicity of chlorination of 

waste water treatment plants. Mass. Water Pollution Control Assoc. September 1986 ($90,000). 

Director of EPA sponsored conference on the Environmental and Health effects of Ozone. U.S. 

EPA. October 1986 ($1 0,000). 

Principal Investigator of a grant from the University of Illinois- Effects of ozone on mice with 

low levels of glucose-6-phosphate dehydrogenase in red cells. January 1985 ($5,000). 

Principal Investigator of a study entitled "The Effect of Environmental pH and ModifYing 

Factors on the Reproduction of Rainbow Smelt." Massachusetts Fish and Wildlife Service. 

January 1985 ($9,873). 

Director of a contract to provide toxicological and risk assessment consultation and research to 

the Connecticut State Health Department. February 1985 ($90,000). 

Principal Investigator of a study to assess possible reproductive hazards in the semi-conductor 

industry. Digital Corporation: Phase I- July 1984 ($244,000); Phase 2- March I, 1985 

($194,000). 

14 
347 


33371.325

Director of the Northeast Regional Environmental Health Center, sponsored by the six New 

England States. Starting October 1985 (goal of $250,000/year). 

Principal Investigator on the assessment of the occurrence of biological factors affecting 

interindividual variation in response to toxic substances. Hercules Corporation. October 1985 

($11,000). 

Director of a national conference on "Environmental and Public Health Eftl-'Cts of Soils 

Contaminated with Petroleum Products." Funded by the Massachusetts Department of 

Environmental Quality Engineering, EPRI, ARCO, Northeast Utilities and other companies. 

October 1985 ($50.000). 

Director of a contract to assess the public health hazards associat~d with leaking underground 

storage tanks. EPRL October 19S5 ($20,000). 

Co-Investigator of a study to assess the possibility of using surrogate parameters in monitoring 

for the presence of volatile organic contaminants in drinking water. American Water Works 

Association Research Foundation. October 1984 ($60,000). 

Principal Investigator of a study to assess the effects of elevated levels of sodium in drinking 

water on school children. Massachusetts Department of Environmental Quality Engineering. 

June I 983 ($1 0,000). 

Developed the concept and proposal for a state-supported Environmental R & D Center. It was 

funded by the Massachusetts Legislature in July 1983 for up to $500,000 per year. 

Director of a grant from the U.S. EPA to conduct an International Conference on Cardiovascular 

Disease and Inorganic Constituents in Drinking Water. August 1983 ($65,000). 

Director of a contract from the Massachusetts Department of Environmental Quality Engineering 

to assess the impact of several plastics manufacturing plants on ambient air quality. September 

1982 ($5,068). 

Principal Investigator of a contract to assess government policy with respect to genetic screening 

in the workplace. U.S. Congress' Office ofTechnology Assessment. January 1982 ($7,400). 

Principal Investigator of a Biomedical Research Grant from the University of Massachusetts 

Graduate Research Council to study the development of an animal model to simulate human 

hereditary blood disorders (i.e., G-6-PD deficiency). April 1982 ($5,000). 

Director of a quarterly newsletter entitled "Health Effects Update" for members of the American 

Water Works Association. May 1982 ($20,000/year). 

15 
348 


33371.326

Principal Investigator of a grant to investigate the efficacy of the guinea pig heterologous model 

to predict the effects of ozone on human erythrocytes with a G-6-PD deficiency. 

Hoffmann-LaRoche, Inc. June 1982 ($10,000). 

Principal Investigator of a grant to study the effects on blood pressure of a reduction in sodium in 

drinking water from 120 ppm to 25 ppm. American Water Works Research Foundation. June 

1982 ($29,000). 

Principal investigator on a study designed to evaluate the effect of ascorbic acid supplementation 

on the body burden of lead. Hoffmann-LaRoche, In. July 1982 ($14,700). 

Co-principal Investigator on an unrestricted grant from the State of Massachusetts Department of 

Environmental Quality Engineering to study the potential of organics in drinking water as 

pollutants in household air. November 1981 ($600). 

Principal Investigator of a grant to investigate the effects of variable dietary ascorbic acid intake 

on the toxicity of a proposed toxic ozone intennediate on human subjects (in vitro). 

Hoffmann-LaRoche, Inc., N.J. December 1981 ($10,000). 

Director of a $41,000 grant from the U.S. EPA to conduct an International Conference on 

Cardiovascular Disease and Drinking Water during May 1979. 

Principal Investigator on a contract from the U.S. EPA to provide a critical assessment of the 

epidemiological and toxicological studies concerning the health implications of widespread use 

of diesel fuel. June 1979 ($9,500). 

Co-principal Investigator on a contract from the U.S. EPA to evaluate the effects of chlorite on 

the kidney, blood pressure, and blood parameters in adult and neonate rats and mice. December 

1979 ($176,198). 

Co-principal Investigator on a grant from the U.S. EPA to conduct a study on the effects of 

elevated levels of sodium in drinking water on cardiovascular function. March 1978 ($950,000). 

Director of a $24,000 grant from the U.S. EPA to conduct an International Conference on the 

Effects of Pollutants on High Risk Groups during June 1978. 

Principal Investigator on a grant from the U.S. EPA to conduct a study on the effects of ozone 

and nitrogen dioxide on mice with low levels of glucose-6-phosphate dehydrogenase in their red 

cells. June 1978 ($211 ,000). 

Co-principal Investigator on a grant from the U.S. EPA to conduct a study on the effects of 

chloramines, chlorite, and copper on pregnant female mice with red cells having low levels of 

glucose-6-phosphate dehydrogenase. July 1978 ($95,000). 

I6 
349 


33371.327

Co-principal Investigator on a U.S. EPA grant to evaluate the effect of chlorine dioxide 

disinfection on neonates born during 1946 in a community that temporarily adopted the use of 

chlorine dioxide for disinfection. 1978 ($50,000). 

Co-principal Investigator of a grant from the Water Research Resources Center at the University 

of Massachusetts to investigate the effects of elevated levels of sodium in drinking water on the 

health of community residents. January 1977 ($4,500). 

Co-Principal lnvestigator. Massachusetts Department of Environmental Protection. 

Determination of heavy metal background levels. June 1997 ($30,000). 

Co-principal Investigator on a contract from the Environmental Protection Agency to conduct: 

(I) a study of the incidence of death from circulatory system causes between two communities 

with markedly different sodium levels in drinking water and (2) an analysis of the difference in 

drinking water quality with respect to minerals and heavy metals between these two 

communities. July 1977 ($10,000). 

Co-principal Investigator on a grant from the U.S. EPA to conduct a study on the effects of 

chlorine dioxide on mice with low levels of glucose-6-phosphate dehydrogenase in their red 

cells. October 1977 ($50,000). 

Principal Investigator of a grant from the University of Massachusetts Graduate Research 

Council- Biomedical Effects Section • to continue studies on the effects of ozone on mice with 

low levels of glucose-6-phosphate dehydrogenase in red cells. December 1976 ($5,000). 

VI. CONSULTING ACTIVITY- Partial Listing 

Occupational Health and Safetv Administration (OSHA). Advisor and expert witness on 

litigation proceedings on the area of establishing health risk to workers in different occupations 

with particular emphasis on chemical coordinating exposure. Consultation has focused on 

carcinogenic risk from exposure to aromatic amines such as 3,3'-dichlorobenzidine and 

"MOCA." 

Environmental Protection Agency lEP A). (I) Invited as a consultant to advise what EPA's 

research priorities should be for FY 1981. (2) Selected to critically review the development of 

several criteria documents for drinking water contaminants (i.e., antimony, copper, cyanide, 

dichlorobenzidine, nickel, and zinc). (3) Selected for a national committee to evaluate the 

methodology by which EPA develops health criteria from which national drinking water 

regulations are established. ( 4) Selected as a member of the solvent taskforce to assess risk to 

the general public from drinking water with variable levels of contamination from a variety of 

common solvents. (5) Invited member of a select committee to advise EPA on developing 

methodologies for dealing with epigenetic carcinogens. (6) Selected to chair the health effects 

committee on nationwide public hearings on volatile organic contaminants in drinking water. (7) 

Selected as a member of an advisory group to help establish methodologies for assessing risk 

17 
350 


33371.328

from carcinogens in drinking water. (8) Selected by EPA to give the principal address on health 

effects of drinking water pollutants at four nationwide workshops concerning the re-evaluation of 

the Primary Drinking Water Standards. (9) Selected by EPA to Chair a congressionally 

mandated study on the comparative health risks of seven different drinking water treatment 

technologies, {10) consultant Scientific Advisory Board (SAB) on dioxin and environmental 

exposures. 

National Semi-Conductor Co. (Danbury. CT). Provide direction for the development of a new 

industrial hygiene program. Supervised the developments of risk assessment resulting from 

occupational exposure to arsenic, arsine, silver, gold, antimony, boron compounds, phophene, 

hydrofluoric acid, acetic acid, silane, and hydrazine. 

North Atlantic Treaty Organization (NATO). Drinking Water and Human Health committee. 

Massachusetts State Pesticide Board. Human health effects advisor to an advisory committee of 

the board. 1977-1981. In September 1981, invited to the State Pesticide Board by the Governor 

for a 4-year term, but declined invitation. 

Ecology and Environment, Inc. (Buffalo, NY). This is an international consulting flffil 

concerned with toxic substance regulation, hazardous wastes, and occupational health. I served 

on a health advisory board, which provides direction for their industrial hygiene program. 

Department of Environmental Quality Engineering {DEQE) for the State of Massachusetts. (I) 

On matters pertaining to ambient air quality standards and toxic substances in drinking water. 

(2) Helped to create a 25-hour course on toxicology and risk assessment for DEQE staff. I 

co-instructed the course. (3) Ad Hoc Committee on sodium in drinking water. (4) Member of a 

committee to develop a statewide air toxic program. 

State of California - Energy Resources Conservation and Development Commission. Provided 

information on human high-risk groups in a power plant setting. 

U.S. Army- Division of Environmental Health and Safety (Fort Dietrick, MD). Provided 

guidance on the development of a program to establish permissible exposure limits to chemicals 

employed in various army occupations. 

National Sanitation Foundation. Nominated and elected to the NSF Council of Public Health 

Consultants from 1980 to 1983, specializing in toxicology. 

Governor's Hazardous Waste Siting Council. Advise the Massachusetts Legislature and the 

Governor on the public health considerations in dealing with the proper disposing of hazardous 

wastes in Massachusetts. 

18 
351 


33371.329

Mitre Corporation. Served on a selected committee to fonnulate and review methodology for 

establishing acceptable exposures to toxicants to U.S. Anny personnel in combat and training 

operations. 

State of Massachusetts- Department of Public Health and Department of Environmental Quality 

Engineering Joint Advisoty Committee on Environmental Risk Assessment. 

National Academy of Sciences. (I) Advised on the development of a possible national study of 

persons at increased risk to environmental pollutants and (2) Participated as a member of the 

Safe Drinking Water Committee. 

Praeger Scientific Publishers !NY). Reviewer of book proposals in the areas of environmental 

and occupational health and toxicology. 

John Wiley and Sons, Publishers !NY). Reviewer of proposed books in the area of 

environmental and occupational health and toxicology. 

MacMillan Publishing Co. (NY). Reviewer of proposed books in the areas of environmental and 

occupational health and toxicology. 

Sybron Corporation (Rochester. NY). To direct a human risk assessment of exposure to 

propylene dichloride. 

Perkins-Jordan, Co. <Portland. ME). Environmental/industrial engineering company advisor in 

the area of toxicity of hazardous substances. 

Office of Technology and Assessment for the U.S. Congress. I am advising in the area of 

genetic susceptibility to pollutants. 

Pierce, Atwood et al. - a Portland. Maine Law Finn. I am advising with regard to risk 

assessment for environmental agents. 

Canal Electric Co. To advise on the possible health risks of switching from 2.2% sulfur oil to 

2.8% sulfur oil for the generation of electricity. 

Research Foundation of the American Water Works Association. To develop and conduct 

courses on toxicology and environmental risk assessment. 

Northeast States for Coordinated Air Use Management (NESCAUM). I have been invited to 

present lectures for NESCAUM staff members on high-risk groups and standard setting during 

their Air Pollution Health Effects Course. January 1981 (Hartford, CT); March 1982 (Durham, 

NH). 

19 
352 


33371.330

U.S. Consumer Product Safety Commission and their contractor. JRB Associates. To advise and 

critically review their studies on consumer products and high risk groups especially children. 

Electric Power Research Institute. 1 have been invited to participate in their nationwide study on 

the human health effects ofinhalable particles from coal-fired power plants, 

Gordon A. Enk and Associates, Inc. (Medusa. NY}. I was invited to advise in the area of 

development of toxicological assays to prevent potential human health effects for coal-fired 

power plants. 

Geomet. Inc. (Rockville, MD). I have advised on projects dealing with toxicological hazards in 

the utility industry. 

American Industrial Hygiene Association. Non-Traditional Shiftwork Periods Ad Hoc 

Committee Membership. July 1982. 

Bioassays, Inc. (Woburn, MA). I have advised in the area of developing animal models for 

predicting the response of humans to ozone and nitrogen dioxide. 

Arthur D. Little Company. I have advised on projects dealing with the role of high-risk groups 

in establishing ambient air standards for mobile source pollutants. 

Dvnamic Corporation. I advise on a project dealing with assessing the toxicological health 

hazards associated with the generation of electricity. 

Waste Management of Wisconsin, Inc. I advise on the health effects of groundwater 

contamination by organic substances. 

Committee on Human Health Effects and Drinking Water for the American Water Works 

Association. 

Center for Environmental Health and Human Toxicology. Advised on the health effects of 

formaldehyde. 

Massachusetts Railroad Association. To advise on the potential human health risks associated 

with herbicide spraying. 

Harvard University. I advise on the carcinogenic potential of diesel emissions from power 

generating plants. 

State of Florida. I advise the State's Department of Environment on development of a water 

reuse policy. 

20 
353 


33371.331

City of Los Angeles, Department of Water and Power. I advise concerning risk assessment of 

carcinogens in drinking water. 

State of Connecticut. Preventable Diseases Division. I advise on several areas of health hazards 

assessment of a wide range of pollutants. 

National Institute of Environmental Health Sciences. Selected for the Third Task Force for 

Research Planning on the Environmental Health Sciences -specialty; Role of host variations, 

1984. 

American Industrial Health Council. I have advised on the areas of risk assessment and in 

developing ways to improve scientific communication with the media. 

Envirologic Data. I advise in the general area oftoxicology and risk assessment. 

Academy of Toxicological Sciences. Selected to peer-review the applications ofthose persons 

seeking to become board certified in toxicology. 

National Science Foundation (NSF). I advise on the area of long-term environmental health 

research goals with particular emphasis on human high-risk groups and risk assessment. 

Council for Environmental Quality (CEQ). I advise on the area of long range planning of EPA 

research goals as they pertain to pollutant effects on high-risk groups and research 

methodologies. 

U.S. Forestry Service. I advise on the human health risk associated with the aerial spraying of 

selected pesticides. 

U.S. Consumer Product Safety Commission. I was selected based on a national competition to 

serve as a member of the Consumer Product Safety Commission's Chronic Hazard Advisory 

Panel on the use ofthe plasticizer, di(2-ethylhexyl)phthalate (DEHP) in children's products, e.g., 

pacifer, rubber pants, etc. 

Scientific Advisory Panel. Health and Human Services, State of Connecticut. 

Media Training. I was one of three toxicologists who participated in an intensive media training 

program which focused on how to be interviewed by the media on environmental issues. This 

was sponsored by Chemlawn Inc. February 1985; I had another media training session in 

November 1985 sponsored by HotTman-LaRoche, Inc. 

Doctor's Data. I was invited to be on the Scientific Board of Directors of this organization. 

February 1985. 

21 
354 


33371.332

National Academy of Sciences. I was appointed to a special study committee commissioned to 

assess the health effects of pollutants in commercial aircraft. 1985 to 1986. 

World Health Organization. r was invited to participate in development of basic research needs 

associated with toxic oil syndrome on June 27-28, 1985, in Copenhagen. 

Associated Industries of Vermont. I advised on the toxicological basis of the proposed State of 

Vermont air toxics program. 

Gulf and Western, Inc. I advise on the toxicological effects of cadmium and lead contamination 

of water, air and soil. 

State of California- U.S. EPA. I advise on the development of methodologies· for establishing a 

health-based air taxies program. 

Rohm and Haas. Inc. I was invited to provide a one-day program on animal extrapolation and 

risk assessment; also, I was invited to critique their approaches for deriving air quality standards 

for air toxics. 

Southern California Edison. I advise on the environmental and public health implications of 

soils contaminated with petroleum products. 

Monsanto. I was selected to be a member of an expert independent panel of scientists to review 

toxicology data of pesticide products. 

Navy. I advise the Navy on the health effects of contaminants in drinking water. 

Svntex Corporation. I advise on the health effects of soil contamination with various organic 

contaminants. 

Tam brands, Inc. [have been invited to become a member of their Institutional Review 

Committee. 

Pacific Power and Light. I have advised in the area of assessing public health implications of 

PCB contaminated soil. 

Digital Equipment Como ration. Assess the health implication of ozone emissions from 

manufactured equipment. 

U.S. Justice Department. Advise on health risk assessment associated with hazardous waste 

sites. 

22 
355 


33371.333

Department of Defense. U.S. Army. Advise on the extrapolative relevance of alternative animal 

models for predicting human responses to environmental toxins. 

Council for Agricultural Science and Technology. Invited to serve on national committee to 

assess risk from 2-4D exposure. 

Alliance Technologies. Advise in the area of risk assessment and toxicology on a variety of 

environmental is.~ues. 

Roy Weston, Inc. Advise in the area of risk assessment and toxicology. 

Colorado Department of Public Health. Advised on the development of risk assessment 

methodologies to estimate human health risks from possible exposure from the Rocky Mountain 

Arsenal. 

NOITE Corporation. Denver, Colorado. Advise on the potential public health risks associated 

with drinking water contaminants. 

Smith. Kline and Beckman. Advise on the public health risks associated with incineration of 

medically related waste. 

Gelman, Inc. Advise on the public health implications of organic contaminants in groundwater. 

GZA Corporation. Advise on the public health risks of petroleum contamination. 

Gelman Sciences. Advise on the public health risk of various issues relating to risk assessment 

procedures to estimate public health hazards for chemical contaminants such as I ,4 dioxane. 

State University at Albany - Center for Policy Research. Advise on the issue of medical 

infectious waste and public health. 

World Health Organization {WHO). I advise on the role of genetic factors in affecting the 

occurrence of occupationally-induced disease. 

Woodward-Clyde Consultants, Inc. Advise on the public health risks associated with exposure 

to taxies from multi-media. 

Environ Com. Advise on the issue of soil ingestion by children. 

W.R. Grace. Advise on various risk assessment issues. 

Committee on Urban Environmental Protection for the Division of Urban Affairs of the National 

Association of State Universities and Land Grant Colleges. 

23 
356 


33371.334

Member of the International Joint Commission, Great Lakes Science Advisory Board's Health 

Committee, 1991-1992. 

Florida Power and Light. Advise on various risk assessment areas. 

3M Cmporation. Advise on environmental and occupational health issues. 

National Academy of Sciences. Invited to be a member of the committee assessing the human 

health effects of the fuel additive MTBE. 

State of Colorado. Advised on risks associated with contamination at the Rocky Mountain 

Arsenal. 1988-present (2002). 

Journal Reviewer (examples of): 

Ageing Research Reviews 

Archives of Environmental Contamination and Toxicology 

Biogerontology 

BioEssays 

BioMed Central Genomics 

Chemical Research in Toxicology 

Chemosphere 

Drug Safety 

Ecology Letters 

Ecotoxicology 

Ecotoxicology and Environmental Safety 

Environment International 

Environmental and Experimental Botany 

Environmental Health Perspectives 

Environmental Science and Technology 

Ecperimental Gerontology 

Free Radical Biology and Medicine 

Fresenius Environmental Bulletin 

Food and Chemical Toxicology 

Frontiers in Bioscience 

GLIA 

Hazarouds Materials 

HortScience 

Human and Experimental Toxicology 

International Journal of Obesity 

International Journal of Toxicology 

Italian Journal of Zoology 

Journal of Alzheimer's Disease 

Journal of Plant Growth Regulation 

24 
357 

Senator ROUNDS. I am going to take just a little bit of liberty 

here. I really do appreciate the participation of all of our witnesses 

here today. 

I look back at the time in which I have had an opportunity to 

serve on this Subcommittee, and the idea on it is to be able to provide oversight, and part of that is to ask questions about how the 

determinations are made. 

Part of the discussion on that, and I think regardless of which 

side of the dais you sit on, you want sound science, and you want 

the opportunity to be able to look at it and to ask the same questions that you would as if we all had scientific background; what 

would we be asking with regard to how that determination is 

made, and what data is available,, and how is it come up with, as 

much to be able to support the regulatory processes and say, look, 

we may disagree with the regulatory outcome, but we understand 

the science that was used behind it, and we can dispute it, or we 

can agree with it, back and forth. 

It seems to me that there must be a way for an agency with regulatory oversight responsibilities to be able to share over a period 

of time a process that could be agreed upon very similar to, and 

I am thinking about the National Science Foundation, where, time 

and again, there are different projects that are looked at, they are 

peer reviewed, they are looked at objectively by outside groups who 

then discuss clearly how they come to a conclusion as to which way 

they work; what should be included, whether or not the projects 

meet the appropriate funding guidelines, and so forth. 

Speaking from experience as a former Governor who worked on 

a National Science Foundation, at that point we were looking at 

National Science Foundation work for an underground laboratory 

to be located in Lead, South Dakota. Matter of fact, Princeton was 

one of the universities which participated in a lot of work. And we 

went through an extended period of time in which there were peer 

review processes to determine whether or not this was one of the 

sites at which an underground laboratory looking for neutrinos 

would be built, and I found it fascinating that although there was 

constant discussion among the different science organizations who 

were working on different locations, there was an acceptance that 

the basic process of sound science would win out. 

Now, whether we use the terms of being able to replicate something or to be able to say that it is verifiable, become items that 

within the science community have clear and defined terms. But 

these are the types of discussions that we need to have if we are 

going to get to the point where, over a period of time, regardless 

of which Administration it is, they should be held accountable for 

using the appropriate science, year in, year out. 

And an oversight committee such as this, regardless of whether 

there are Republicans responsible for operating as a majority or 

Democrats, and regardless of whether the Administration is Republican or Democrat, there should be certain accepted standards that 

either Republican or Democrat administrations should be held to 

adhere to with regard to how the regulatory processes are determined, and the accepted facts that are being used in making those 

regulations. That is what this is all about. 

358 

I don’t think there is anything wrong with questioning the existing program which is out there, because most certainly there are 

questions that are raised on a regular basis. It does not mean that 

any one of the existing proposals is perfect, but most certainly I 

think the discussion that you all have held today, and the differing 

points of view that you have, has been very helpful to this Committee in trying to move forward, and I would just thank you all 

for your input today. 

Senator WHITEHOUSE. Can I ask two more unanimous consents? 

One to put into the record a memorandum from the public relations 

firm of Bracewell and Patterson dating back to 1996 for the R. J. 

Reynolds Tobacco Company, and the other an action plan called 

The Secret Science Action Plan, prepared for Phillip Morris. 

Senator ROUNDS. Without objection. 

Senator WHITEHOUSE. Thank you, sir. 

Senator ROUNDS. Thank you. 

[The referenced information follows:] 

359 


33371.335

From: Christopher Horner 

To: Hyde, Timothy N.; Tompson, Randy 

CC: 

BCC: 

Subject: Federal Agency Science 

Date: 12/23/19961:56:01 PM 

Attachments: 

----·-------------· -------

Gentlemen: The following is the document we discussed. Have a happy 

holiday. CCH 

MEMORANDUM 

TO: Mr. Tim Hyde 

Mr. Randy Johnson 

RJ Reynolds Tobacco Company 

FROM: Mr. Christopher C. Horner 

Bracewell & Patterson, LL.P. 

DATE; December 23, 1996 

RE: Background and Proposed Program to Address Federal 

Agency Science 

Per our earlier conversations, the following sets forth what needs to be 

done to reform agency science, focusing on the need based upon your 

interests, and how you are positioned to take a behind the scenes 

leadership position. It provides an overview of the issues relevant to this 

goal, and details a program taking advantage of the increasingly flagrant 

way regulators have perverted the scientific process, hiding behind a 

wall of selected scientists to essentially cow industry and Congress into 

accepting fringe scientific conclusions. 

Summary 

We propose creating, beginning with congressional oversight and a goal 

of enacting legislation, required review procedures which EPA and other 

federal agencies must follow in developing "extra-judicial" documents 

(i.e., those documents produced as guidance, science or other 

government products issued by regulatory agencies which are not 

necessarily at time of publication ripe for judicial review). This is 

important to your organization because, at some point in the near future, 

EPA will most likely be ordered to re-examine ETS. The only way to do 
360 


33371.336

so on a level playing field is to construct explicit procedural hurdles the 

Agency must follow in issuing scientific reports. 

Because there is virtually no chance of affecting change on this issue if 

the focus is ETS, our approach is one of addressing process as 

opposed to scientific substance, and global applicability to industry rather 

than focusing on any single industrial sector. Thus the examples of 

questionable science, to justify these standards. Congress must require 

those examples serve as the test cases. 

Background 

On the surface, now appears an opportune moment for addressing 

agency science head on, tackling the substance. This would seem the 

case because the first run at legislative attempts to reform the regulatory 

process failed and concerned Members are searching for a new 

mechanism to control EPA and other regulatory bodies. The landscape 

of the past year is littered with examples of persistent or 

newly-promoted "bad science," including the Mercury Report to 

Congress, MACT Hazardous Waste Combustion Rule, Methylene Chloride 

and the Dioxin Reassessment. Regarding the latter example, as you are 

likely aware, for the next round of EPA Science Advisory Board (SAB) 

review of the Dioxin Reassessment the Agency has removed any SAB 

members who were too vocal in their disagreement with the Agency. 

There will still be SAB review, but it will be an already-transparent group 

of "agreeable" scientists. So. in addition EPA is flagrantly "stacking the 

deck" with those whose conclusions are predetermined and in the 

Agency's favor. 

Irrespective of this pattern, it is clear the i04th Congress was singularly 

unsuccessful in managing the Agency on a chemical-by-chemical or 

industry-by-industry basis. EPA actions demonstrate the it has taken 

measure of its legislative and industry adversaries, and decided upon 

aggressive campaigns on several of these issues to impose its 

policy-driven will upon scientific conclusions. The Agency helps create, 

and responds, to, the political winds, so you should anticipate no relief 

on re-evaluating ETS. EPA has of late played its public relations card 

very well, avoiding long news cycles for its proposals •• even timing 

them around holidays when readership is at its nadir -while engaging 

the environmental press for the coming conflicts. EPA, helped by the 

backlash of the generally "pro.environment" public to a poorly 

implemented reg-reform agenda, has fostered an atmosphere where 

"industry" are reluctant to match the Agency's hardball tactics out of fear 

either that Congress would duck/mismanage the issue, or of Agency 

retribution. Thus, through a lack of industry support and unfavorable 

press, Congress has to date lacked the requisite support to effectively 

use the oversight powers of the legislative branch. 
361 


33371.337

It is in this climate you will face a chastened but at least as aggressive 

EPA on re--evaluating the ETS study. 

Project Approach 

To improve the climate, and process, under which ETS and others are 

reviewed, we recommend initiating reforms by playing a strong role in 

molding and guiding Congress's oversight of EPA's latest Clean Air Act 

initiative (on PM 2.5/ozone). Such an effort would work toward requiring 

EPA to institute certain procedural changes to the pre-regulatory 

process. These would seNe as a set of checks and balances to ensure 

a fair and equitable development and publication of scientific findings 

(Le., reform the scientific process). It is that process, which is beyond 

the reach of the Administrative Procedure Act, which sets the stage for 

the rulemaking process. These procedures could then be subject to 

judicial review without the courts becoming involved in specific scientific 

issues (i.e., discern if EPA followed the requisite steps, rather than if it 

achieved the "right" answer). 

When EPA announced its proposal to regulate particulate matter and 

tropospheric ozone, despite their news cycle management, the set the 

predicate for procedural change. These proposed regulations, based on 

questionable science, are not focused on those industries that comprise 

EPA's "usual suspects", but rather aU industries including small 

businesses. Congress is expected to conduct heavy oversight of this 

process, with most leaders expressing that the actions are unnecessary 

and unrealistic. EPA has already signaled a desire to compromise as the 

process moves forward, and will start airing its options in the January 

14~15 initial public hearings. It is critical to our overall goal that EPA not be 

allowed to change the forum into an industry-by-industry examination. 

Equally important, the process should not devolve into "outdoor air" 

interest seeking to shift the focus to "indoor air" interests. Instead, the 

efforts we envision focus on the process by which EPA arrived at its 

scientific conclusions, avoiding to the extent possible specific scientific 

issues, contaminants, or industries. 

While some will approach these hearings as regulation~specific, as you 

can appreciate, from our perspective the greater problem is EPA (and 

OSHA) "science," encompassing all the scientific reports, studies, 

guidance documents and procedures produced by the nonregulatory 

offices of these agencies. None of these products are subject to timely 

challenge. In some instances, industry must wait years before 

regulations are promulgated, thus allowing industry to sue. Then, when 

industry has that opportunity, the court is faced with the ramifications of 

overturning years of EPA actions and policies based on this scientific 

document. Moreover, industry face mindsets such as "how can a 
362 


33371.338

document which has been around for so long be wrong?" (the "historical 

credibility" argument). Finally, once industry's hands are tied in 

Washington, EPA or OSHA has distributed the documents or guidance to 

the press or states, forcing industry to face a public relations nightmare. 

Thus, as we see!< to create a regime where this cycle is a thing of the 

past while highlighting problems with contemporary studies. These 

studies will be the first ntest cases" for the reformed process. This 

requires developing (1) overall criteria for a "sound science" process, 

and (2) a record, through congressional oversight, on how the Agency 

typically does not meet those criteria. 

To illustrate, criteria could be as follows: 

"Sound Science" Criteria- any government scientific program must have 

four components: 

Inclusive- The scientific community, the public, Congress, and 

other Executive Branch agencies are given fair and timely access 

to review and affect change in the development of the 

science/document. 

Transparency- the public can follow the developmental process 

the steps followed to develop the final science/document. 

Able to be reproduced- Can the answer be reproduced from the 

record? 

Algorithm - Given the set of all available scientific knowledge on 

the subject would independent groups arrive at the same answer? 

fa possible fifth component which could be included as a deal 

closer could be: 

Not judicially reviewable -This may seem counterintuitive, but one 

of the aspects of reg-reform which its opponents exploited to 

bring it down was the belief that everything would be litigated. Thus, 

it may be possible to achieve reforms through the principle that the 

scientific portions of a successful program should not be easily placed 

before the courts. Instead, the courts should be able to easily look at 

procedures followed (e.g., did the Agency follow its own 

procedures).} 

We envision these new steps being "field tested" on, e.g., the methylene 

chloride study, ETS, etc. which, having been used as justification for 

reform would be he!d and reviewed under the new procedures. 

To ensure Agency compliance Congressional oversight is also required. 

This at worst builds a record for judicial review and at best sets in 
363 


33371.339

motion a set of enforceable procedures. We intend to develop for the Hill 

a set of scientific and procedural questions on scientific issues which 

different committees could then use. This requires: 

Written Record - Submit lengthy, detailed questions to the agency 

requiring written responses. This creates a written record which 

the Agency often seeks to avoid, because it otherwise is permitted to 

develop scientific documents without responding explicitly (unlike the 

proposal/promulgation process) to public concerns. 

Followup Hearings • Once the Agency has responded use this 

record both within and across an issue in oversight on how the 

Agency develops science. (e.g., this is an ideal place to inquire into risk 

assessment default values and risk criteria, which seem to change from 

office to office). 

We envision the end results of the oversight hearings to be: (1) EPA 

publication in the Federal Register of a formal process for handling 

"extra-judicial" documents; (2) new legislation; and/or (3) inclusion in 

environmental or regulatory reform legislation which appears moving in 

the 1 05th Congress. 

This approach merely ensures a fair hearing, but that is typically all the 

situations require to avoid the skewed result the federal agency 

prescribes. Critically, this approach also circumvents the tenuous 

situation you otherwise likely will face, of seeking after-the-fact, 

RJR-specific congressional support to undo the Agency's work. 

What makes the National Association of Manufacturers a strong base for 

the above work is NAM's broad, yet non-specific, business base. Its one 

of a small handful, at best, of broad based associations not associated 

with particular industries. Thus, their lead on this general issue will not 

bog the hearings down in "anti-environmental," industry-specific rhetoric, 

nor create an environment where specific industries can legitimately fear 

Agency retaliation. 

Conclusion 

We envision a program, using contemporary studies and reports to 

illustrate how the Agency skews its results in the pre-regulation stage, 

to create set, reviewable science procedures. That process and its 

criteria will first be tested on those current examples of Agency 

misfeasance, which obviously must be sent back to the Agency or 

otherwise placed on hold in the interim. We need to meet again with you 

to discuss this proposal and how to best implement it, specifically 

beginning with the audiences with NAM and NFIB we discussed. We 

need another meeting, to hammer out the presentation to the two 
364 


33371.340

referenced audiences, and reach consensus with you on the issues and 

approach we intend to pursue. Until we speak with you on this further, 

Happy Holidays. 

CCH 

/cch 
365 


33371.341

33371.342

A PUBLIC AFFAIRS CAMPAIGN 

MOUNTED IN THREE PHASES: 

PHASE 1: LAYING THE GROUNDWORK 

April1- June 1998 

PHASE II: BUILDING A CRITICAL MASS OF "OUTRAG

June - December 1998 

PHASE ill: SUPPORTING A SOLUTION 

1999 

Secret S
367 


33371.343

I 

~ ~ 

~ 

~ ~ 

~ I 

~ 

~ 

~ ~ 

I 

I 

I -

N 

0 

()) 

..... 

(,.) 

~ (II 

<.n 

N 

33371.344

PHASE I OBJECfiVES: 

• Identify and Document the Problem 

• Begin to Build a Critical Mass of Bi-partisan 

Support 

Secret S

33371.345

PHASE I STRATEGY: 

• Recruit Organization to Act as Initial Catalyst 

• Leverage Relationships to Develop Core Alliance 

II Catalyst Organization 

• Boland & Madigan 

II Powell Tate 

Secret S

33371.346

PHASE I EXECUTION 

• Statement of Position 

• Plain Language 

• Baseline for Agreement 

II "Mantra" for Outreach 

Secret S

33371.347

PHASE I EXECUTION 

• Soft Testings: "Unofficial" Outreach to "Friends" to: 

II Assess Interest in Issue 

a Gauge Appetite For Activism 

II Identify Pitfalls and Vulnerabilities 

II Determine Potential for Additional Third-party Outreach 

• Backgrounder Used as Departure Point 

• Findings Compiled and Used as Departure Point For 

Recruitment 

Secret Sc

33371.348

PHASE I EXECUTION 

• Recruit Founding Member to Serve as Catalyst 

• Gma 

• Business Roundtable 

• Nam 

• Create Low-keyed But Powerful Presentation to 

Make the "Pitch" 

LSSvZ£&.80Z Secret S

33371.349

PHASE I EXECUTION 

• Conceptual Research: Qualitative Independent 

Research to Determine 

• Initial Opinion Leader Reaction/response to the 

Issue/ concept 

• Potential Fissures Within "Scientific Community" 

• May Be Used Externally As Well As Internally 

• Helps Solidify Strategy & Messages 8SS17Z£~SOZ Secret S

33371.350

PHASE I EXECUTION 

• Third Party Education and Recruitment -- Two Tiers 

II Associations/public Interest Groups 

+ Philosophical Support 

+ Spokespeople, Especially Within State Organizations 

+ Bi-partisan Appeal 

II Corporations 

+ Monetary and Philosophical Support + Spokespeople, Especially Locally 

+ Political Appeal 

Secret S

33371.351

I PHASE I EXECUTION 

• Education and Recruitment Via 

II F onnal Presentation 

+ Power Point Presentation 

+ Flip Book 

+ Case Studies 

+ 4-5 Page Backgrounder 

• Boland & Madigan/Powell Tate Relationships 

+ Clients and Contacts 

+ Ally Development Experts 

8 Catalyst Organization Contacts 

II Client Contacts 

09St>Z£ HlOZ Secret S

33371.352

• Core Group Targets: 

• Food 

Ill Energy 

Ill Communications 

II Transportation 

Ill Health Care 

Ill Waste Management 

II Labor 

II General Manufacturing 

II Government Transparency 

II Taxpayer Rights 

"Science" (Professional Organizations) 

~ssv~£~aoz Secret S

33371.353

,-PHAsE I EXECUfiON 

• Strategy And Plan Preparation-- Phases II & III 

• Broadening Coalition 

• Media Outreach, National and Local 

• Fundraising 

II Additional Research For Public Consumption 

II Internet 

II Government Relations 

Z9St'Ztt.BOZ Secret S
378 

Senator ROUNDS. With that, once again I want to thank all of our 

witnesses here today. You add to the discussion. 

I would also like to thank our colleagues who have attended this 

hearing for their thoughts and questions. 

The record will be open for 2 weeks, which brings us to Wednesday, October 17th. 

With that, this hearing is adjourned. 

[Whereupon, at 3:35 p.m. the Committee was adjourned.] 

[Additional material submitted for the record follows:] 

379 


33371.354

----------------------------Paper----------------------------

CASE-CONTROL STUDY OF LUNG CANCER RISK 

FROM RESIDENTIAL RADON EXPOSURE IN WORCESTER 

COUNTY, MASSACHUSETTS 

Richard E. Thompson,* Donald F. Nelson,' Joel H. Popkin,* and Zenaida Popkin1 

Abstract-A study of lung cancer risk from residential radon 

exposure and its radioactive progeny was performed with 200 

cases (58% male, 42% female) and 397 controls matched on 

age and sex, all from the same health maintenance organiza~ 

tion. Emphasis was placed on accurate and extensive year-long 

dosimetry with etch-track detectors in conjunction with care· 

ful questioning about historic patterns of in-horne mobility. 

Conditional logistic regression was used to model the outcome 

of cancer on radon exposure, while controlling for years of 

residency, smoking, education, income, and years of ,job expo· 

sure to known or potential carcinogens. Smoking was accounted for by nine categories: never smokers, four categories 

of current smokers, and four categories of former smokers. 

Radon exposure was divided into six categories (modell) witb 

break poinlli at 25, 50, 75, 150, and 250 Bq m-\ the lowest 

being the reference. Surprisingly, the adjusted odds ratios 

(AORs) were, in order, 1.00, 0.53, 0.31, 0.47, 0.22, and 2,50 

with the third category significantly below 1.0 (p < 0.05), and 

the second, fourth, and firth categories approaching statistical 

significance (p < 0.1). An alternate analysis (model 2) using 

natural cubic splines allowed calculating AORs as a continu~ 

ous function of radon exposure. That analysis produces AORs 

that are substantially less than 1.0 with borderline statistical 

significance (0.048 s: p s 0.05) between approximately 85 and 

123 Bq m-3

• College-educated subjects in comparison to high~ 

school dropouts have a significant reduction in cancer risk after 

controlling for smoking, years of residency, and job exposures 

with AOR; 0.30 (95% CJ: 0.13, 0.69),p; 0.005 (model!). 

Health Phys. 94(3):228-241; 2008 

Key words: 222Rn, indoor; cancer; risk analysis; honnesis, radiation 

INTRODUCTION 

ExrosURE ro radon gas has been shown to be a significant 

cause of lung cancer. Radon here means specifically the 

* Bio<otatistics Department, Johns HopkJns Bloomberg School of 

Public Health, Baltimore, MD 21205; t Department of Physics, 

Worcester Polytechnic Institute, Worcester, MA 01609: t St. Vincent 

Hospital and Fallon Clinic, Worcester Medical Center, Worcester, MA 

01608. 

For correspondence contact Richard E. Thompson, Department 

of Biostatistics, Johns Hopkins D\oomberg School of Public Health. 

615 N. Wolfe Street, Baltimore, MD 21205, or email at rthompso@ 

jhsph.edu. 

(Manuscript accepted 29 August 2007) 

0017-9078/08/0 

Copyright ![) 2008 Health Physics Society 

228 

mRn isotope along with it.;; radioactive, alpha-particle-emitting 

progeny. 222Rn arises as a decay product of 226Ra. which 

is widely dispersed in rock and soil. Though 122Rn has a 

half-life of only 3.8 d, its chemical inettness allows it to 

emerge from the rock and soil into confined spaces where 

it accumulates. It has been recognized as a significant 

lung-cancer risk for underground miners for some time. 

The BEIR VI report (NRC 1999) analyzed the pooled 

data from II cohort studies of the lung-cancer risk from 

radon exposure of underground miners using a linear, 

no-threshold (LNT) model of the excess relative risk. 

The report did recognize that a threshold at well below 

typical miner exposures could not be ruled out. Because 

miner exposures were typically 30 times larger than the 

residential exposures of people, the extrapolation of risk 

to those lower exposures involves considerable uncertainty. Nevertheless, the U.S, Environmental Protection 

Agency (U.S. EPA 2003) based a reassessment of lungcancer risk from radon in homes on the BEIR VI report 

with only minor revisions in procedure and results. 

Well over twenty case-control studies of the lungcancer risk from radon in homes have now been reported 

for North American, European, and Chinese locations in 

order to assess more firmly the risk at lower exposure 

levels. While many, but not all, report an excess risk, the 

95% confidence intervals (Cis) in the great majority of 

them include the possibility of no excess risk, which 

would occur if a threshold were to exist A pooled 

analysis of the seven North American studies has recently appeared (Krewski et al. 2005, 2006). The data 

were found to fit an LNT model with "no apparent 

evidence of nonlinearity throughout the range of radon 

concentration observed." The slope of the excess odds 

ratio (OR) was found to be 0.10 per 100 Bq m' 3 in fine 

agreement with the BEIR VI slope deduced from the 

pooled miners data. The 95% Cl, -0.01-0.26, however, 

still includes tbe possibility of a threshold. A recent 

pooled analysis of 13 European studies (Darby et al. 

2005) has also found agreement with the LNT model 

with a slope of 0.08 per 100 Bq m-' with a 95% Cl, 
380 


33371.355

Lung cancer risk from residential radon e R. E. THOMrso;-; ET AL. 229 

0.03-0.16, that excludes a threshold with statistical 

confidence. Two poolings of Chinese data have been 

published. The earlier one (Lubin 2003) found an excess 

OR at 100 Bg m- 3 of 0.139 with 95% Cl of 0.01-0.37. 

The later study (Lubin et al. 2004) found an excess OR at 

100 Bq m- 1 of 0.33 with 95% CJ of 0.01-0.36. Thus, 

both of the Chinese poolings exclude a threshold. A 

meta-analysis of seventeen case-control studies also suggested a linear dependence (Pavia et al. 2003). 

In view of the unusual and unexpected trend of the 

adjusted odds ratio (AOR) vs. radon exposure found in 

this study, to wit, a protective effect, it is worth examining the literature further. First, while a number of the 

particular case/control studies found individual AOR 

values below one, that is, protective or honnetic, none 

found any statistically significant trends in that direction. 

It is, however, a curious fact (investigated in greater 

detail in the Discussion section) that the pooled study of 

Krewski et al. (2005, 2006) has unadjusted ORs that are 

strongly hormetic. Ecologic studies of lung cancer vs. 

radon exposure have had scattered results and, of course, 

lack the individual matching of case-control studies. It is 

interesting, however. that hy far the largest and most 

fully analyzed such studies (Cohen 1995, 1997) found a 

hormetic result. These have been criticized on a number 

of grounds and defended. The BEIR VI report (NRC 

1999) reviewed these and other ecologic studies and 

issued a strong judgment: They are not "informative" 

because of ''inherent limitations of the ecologic method." 

This paper presents a case-control study of lung 

cancer incidence vs. residential radon exposure in 

Worcester County, Massachusetts, carried out between 

1990 and l 999 with both cases and controls from a single 

health maintenance organization. Each case was matched 

individually by age and sex to two controls. In contrast to 

previous case-control studies, evidence supporting a 

hormctic dose-response for radon exposures less than 

150 Bq m- 3 was found. This effect remains marginally 

statisticaHy significant even after controlling for potentially confounding variables, including age and sex by 

the matching of the cases and controls, and smoking 

history, years of residence, income, education, and occupational exposure to suspected carcinogens in multi~ 

variable regression analyses. At a time when intemational consensus is being sought on the lung cancer risk 

of low radon exposure, it may be regarded as unfortunate 

to have a nonconforming study appear, but the results 

were obtained using objective, scientific methods and 

required peer-reviewed reporting. In addition, many aspects of this study rank it among the most careful ones in 

both data collection and analysis. 

STUDY DESIGN 

This study was encouraged as an adjunct study to 

the Connecticut Study (Sandler et al. 2006) and followed 

the protocol therein except for a few modifications as 

required by a lower budget, most significantly testing of 

only the current home. Approval to recruit cases and 

controls was obtained by the Institutional Review Board 

of the St. Vincent Hospital and Fallon Clinic. Both cases 

and controls were clients of the Fallon Clinic\Fallon 

Community Health Plan. Subjects of the study were 

residents of Worcester County, or for a handful of 

subjects. residents a few miJes over it.s borders. Cases 

with histologically or cytologically confirmed primary 

lung cancer were eligible to participate in the study if 

they were at least 40 y of age, had the permission of their 

primary care physician. had lived in a radon-testable 

residence a minimum of 10 y, and were not cigar or pipe 

smokers (cigarette smoking being accepted). Among 

never smokers, all cases were histologically confirmed, 

except for unavailable path specimens in 3 of a total of 15 

patients, while smokers with "non-small cell" cancer had 

cytological confirmation (a total of 8 cases). The pathology was not available for 20 smoking cases. All cases 

were confirmed by a single, blinded pathologist (Chief of 

Pathology, St. Vincent Hospital). 

Of 580 cases considered for the study, 113 refused 

entry, 102 did not meet the residency requirement, 62 

were not given physician approval to participate, 89 died 

before both the case's physician and the case subject had 

agreed upon participation in the study. 5 were disqualified for cigar/pipe smoking, and 209 were enrolled in the 

study. Radon detectors were lost for 9 of these, leaving 

200 cases in the study. Males comprised 58%, females 

42%. The cancer pathology of the cases indicated 59 

(29.5%) with adenocarcinoma, 44 (22.0%) with small 

cell carcinoma, 20 (10.0%) with large cell carcinoma, 44 

(22.0%) with squamous cell carcinoma. 10 (5.0%) with 

other, and 23 (11.5%) with no available pathology. 

Controls were randomly selected by computer from 

the same client population. Two were matched individually to each case on .sex and age to within ±2.5 y using 

date-of-birth (independent of year-of-participation). Of 

939 controls considered for the study, 292 refused entry, 

146 did not meet the residency requirement, 87 were not 

given physician approval to participate, 13 were disqualified for cigar/pipe smoking. and 40 I were enrolled in the 

study. Radon detectors were lost for 4 of these, leaving 

397 controls in the study. By default, 99% of the sobjects 

were Caucasian. 

A questionnaire was filled out by a trained interviewer during a face-to-face interview for every case and 

control. Because of illness or recent death. a surrogate (a 
381 


33371.356

230 Health Physics ~arch 2008, Volume 94, Number 3 

spouse or offspring) wa..:; interviewed for 21.5% of cases 

and 3.3% of controls. A detailed smoking history of the 

number and type (unfiltered or filtered) of cigarettes 

smoked per day for each year in the subject's life was 

obtained. The years of residency of the home and any 

structural changes made during that time were recorded. 

Previous radon testing and radon remediation were ascertained. Among cases and controls, 7.5% and 9.8%, 

respectively, had had the home tested, but only 0.5% of 

eases and 5.5% of controls could remember the result. 

Only one home had had any remediation, and that was 

minimal (crack filling). The subjects were questioned in 

detail concerning hours per week spent in wakeful living 

areas and bedroom(s) and any other level of the house. 

usually the basement, where the subject spent one or 

more hours per week. Sleep was assigned eight hours per 

night This distribution of occupancy time was determined over days of the week and weekends, over seasons 

of the year, and for each differing lifestyle period (full-time 

work, part~time work, retirement, child-rearing, etc.). 

These questions determined the placement of detectors in 

the house. A job history of each subject was obtained, 

and corresponding years of occupational exposures to 

heat welding, asbestos, vinyl chloride, formaldehyde. 

ethylene oxide, x-rays, radioactivity, insecticides, herbicides, smelter fumes. and foundry fumes were obtained. 

Fina1ly, stratified family income and years of education 

were requested. Table 1 summarizes many of these data. 

DOSIMETRY 

Radon concentrations were measured in yearlong 

exposures of Radtrack etch-track detectors (Tech/Ops 

Landauer, Inc., 2 Science Road, Glenwood, IL 60425) in 

the present, or for a few subjects, the immediate past 

residence that had been lived in for a minimum of 10 y. 

Before forwarding each batch of exposed detectors for 

reading by Tech/Ops Landauer, Inc., the U.S. EPA's 

National Air and Radiation Environmental Laboratory in 

Montgomery. Alabama, disguised "blanks" (unexposed 

detectors) and "spikes" (detectors given a cnlibrated 

exposure) in each batch (Smith et al. 1992). The number 

of spikes and blanks disguised in each batch was determined by the Montgomery EPA testing lab, and typically 

contained two spikes and one blank per batch. A cotTection factor of the calibration value divided by the 

Table l. Study population demographics, smoking status, and radon exposure. 

Covariate Controls (N 397) 

Mean (SD) radon expo.'>ure 

Same as above, one outlier removed 

Median radon exposure 

Same as above, one outlier removed 

Sex 

Women 

Residency (y) 

<20 

20--39 

~40 

Mean (SD) time of residency (y) 

Mean {SO) time in home (h wk- 1

) 

Mean (SD) age (y) 

Smoking status 

Never smoker 

Former smoker 

Current smoker 

Total job exposure (y) 

0 

t-9 

"''o Education 

<High school 

High school 

At least some college 

Refused 

Income (S y- 1

) 

<30,000 

2:)0,000 

Refused 

·' T-test of natural logs, 

hKruskai-Wallistest. 

··Two sample Hest. 

d Chi-squared test 

66.3 (65.2) 

50.! 

229 (57.7%) 

[68 (42,3%) 

90 (22.7%) 

203 t5LI%) 

!04 (26,2%) 

30.6 (!2.1) 

113.6 (18.2) 

67.7 (10.0) 

162 (40.8%) 

196 (49.4%) 

39(9.8%) 

290 (73.0%) 

52(13.1%) 

55(13.9%) 

77 (19.4%) 

149(37.5%) 

165 (41.6%) 

6(1.5%) 

159 {40.!1)() 

190(47.9%) 

48(!2.1%) 

Cases (N"" 2(XJ) p·valuc 

67.5 (! 18.5) 0.086"' 

60.2[59.4) 0.047' 

43.7 0.039h 

43.6 0.030h 

0.966h 

115 (57.5°/o) 

85 (42.5%) 

O.OS!d 

62 (31.0%) 

94(47.07() 

44 (22,0%) 

285 (12.!) 0.049' 

116.6 (17.9) 0.052" 

66.6 (9.7) 0.225" 

<0.001d 

15(7.5%) 

80(40.0%) 

105 (52.5%) 

0.! 12d 

<O.OOld 

67(33.5%) 

90 {45.0%) 

40 (20.0%) 

3(1.5%) 

<0.001'1 
382 


33371.357

Llmg cancer risl. from residential radon e R. E. THOMPSON ET AL 231 

Landauer reading was found for each spike, and an 

average of those correction factors for a particular 

analysis batch was applied (multiplied) to each Landauer 

measured value in that batch. Such corrections averaged 

a 19% increase. Another quality assurance procedure was 

to place two detectors side by side for exposure in 

approximately one-tenth of all homes. Sixty-four such tests 

were conducted. The coefficient of variation for the duplicate readings was l 2%, which is thus a measure of the 

precision of individual radon concentration measurements. 

The radon detectors were placed in the house after 

administering the questionnaire and thus determining the 

usage of various parts of the house. Detectors were 

always placed in the living area most often used, in the 

present bedroom, and in any former bedroom. Also, a 

detector was placed in any other level of the house that 

had been used on average for one or more hours per 

week. Typically this was the basement, but occasionally 

an upper story of the house when the bedroom was on the 

ground level. 

The exposure rate was then calculated as a doubly 

weighted average of the various detector measurements: 

first, an average weighted by the fraction of hours per 

week usage of the particular area in a given lifestyle 

period. and second. an average of such averages 

weighted by the number of years of each lifestyle period 

during residency in the house (the most recent five years 

being exduded as a latency period). This i.s a more 

elaborate and accurate method than that used in the 

pooling of data (Krewski et al. 2005, 2006), where a 

"living area•· (sometimes an average of the living area 

and bedroom) measurement was used. The importance of 

resident mobility within the house in determining the 

average exposure has been studied and emphasized by 

the lowa group (Field et al. 2000). A sub-analysis 

presented below supports this thinking. Two extreme 

examples that occurred in this study illustrate the point. 

One subject with full-time employment lived in a twostory house but spent 50 h per week in the basement 

Another subject lived entirely in the basement for a 

number of years before building the upper two floors of 

the house. 

Several yearlong etch-track detector tests of outdoor 

Worcester County air yielded either below detectable, or 

barely detectable, concentrations {average ~10 Bq m~ ). 

Thus, only in-house exposure was considered in this 

study. It is worth mentioning that no exposure contribution was imputed for any of this study's subjects; all 

contributions were measured. The few subjects for whom 

exposure measurements were lost (in spite of a written 

request on the detectors to be notified in case of death, 

occupancy change, etc.) were dropped from the study. 

For our study population of 597 subjects, we found the 

mean (standard deviation, SD) and median radon concentrations for the living area to be 63.5 (79.4) and 44.0, 

for the bedroom to be 61.6 (77.6) and 43.3, and for the 

basement (419 subjects) to be 176.8 (185.7) and 133, all 

in units ofBq m- 3

, 

One detector problem encountered in this study is 

worth mentioning. The EPA furnished the detectors for 

this study all at once. and the manufacturer did not list 

any shelf life for them. Thus, after six years into the 

study, it was a surprise to find that the "blanks" began to 

show small non-zero readings. A conversation with the 

detector maker§ revealed several things: (1) there is an 

aging phenomenon in etch-track detectors which causes 

the background (unexposed) reading to increase with 

time; and (2) the reading procedure of the detector maker 

uses a background subtraction procedure determined 

from samples of the same plastic sheets (typically held 

for four years) that the exposed detector came from. The 

conversation thus affirmed a procedure of subtwcting the 

average reading of the "blank'' detectors from the readings of exposed detectors in that batch. Many "blanks·· 

were then placed in the following batches to better 

evaluate the effect until new detectors were furnished. A 

plot of aU the corrected measurements vs. the time of 

measurement showed no secular variation, thus supporting the ~ubtraction procedure. 

STATISTICAL ANALYSIS 

All analyses were performed using the statistical 

software package Stata Release 8.0 (Stata Corp. 2003). 

As an initial step, exploratory analyses were performed 

on the data to summarize and quantify data spread and to 

look for important trends. Initial confirmatory analyses 

were used to investigate the statistical associations between the outcome of lung cancer (case or control) and 

several explanatory variables. In order to test for statistical associations, the chi-squared goodness-of-fit test 

was used on the categorical data, while the two-sampled 

t test was used for continuous outcomes. The nonparametric Kruskal-Wallis test for differences in the 

medians was also used. Potential outlier observations 

were identified using the Extreme Studentized Deviate 

(ESD) statistic method as described by Rosner (2000). 

Conditional logistic regression was used to model 

the binary outcome of cancer status on radon exposure 

rate (in Bq m- 3

) while controlling for potential confound~ 

ers including years of residency, smoking status. education (<high school, high school graduate, and at least 

some college), household income ( :5$30,000 vs. 

~ Private communication. Mark Salasky. Tech/Ops Landauer: 

1996. 
383 


33371.358

232 Health Physics 

>$30,000), and total years of job exposure to known or 

potential carcinogens (0 y, 1-9 y, and "'10 y). Due to the 

large number of respondents who refused to give their 

household incomes or, to a lesser extent, education level, 

refusals for these two variables were considered as 

separate categories in the regression models. 

Persons were considered former smokers if they had 

not smoked within two years of their interview date. 

Current smokers were classified into categories of packyears smoked, while former smokers were categorized by 

the time since last smoked. The number of filtered 

cigarettes smoked was multiplied by a weight factor of 

0.8 compared to unfiltered cigarettes. "Filtered" cigarettes have changed with time over the decades of this 

retrospective study, and smokers' response to them has 

been found to change also, making any such factor rather 

speculative. The assumption of a modest reduction of 

inhaled carcinogens of 20% seems to be reasonable, and 

was used in calculating smoking intensity. Pack-years of 

smoking were calculated as the lifetime-averaged number of packs smoked per day multiplied by the total 

number of years of smoking. The number of years 

smoked was given to the nearest year. 

Because of the imp01tance of smoking as a potential 

confounder, several alternative ways of modeling smoking into the multi variable regression models were considered. Preliminary univariate analyses and log-odds 

plots revealed a strong positive relationship between 

pack-years smoked and cancer among current smokers, 

and an inverse, non-linear relationship between time 

since last smoked and cancer among former smokers. 

Among former smokers, initial analyses revealed no 

statistical correlations between pack-years and cancer. 

Neither age when first smoked nor age at quitting for 

former smokers was found to be statistically associated 

with cancer. In addition, no statistically significant multiplicative interaction tenns between smoking and radon 

were found. Based on these preliminary results, it was 

determined that the smoking data were best modeled 

with categories of pack-years ror current smokers, and 

categories of time since last smoked for former smokers. 

The total job-related exposure in years to all the 

known and potential carcinogens, listed above, was taken 

as a covariate. No data were available on the intensity of 

the exposure. Preliminary univariate analyses on individual compounds revealed some marginal statistical associations with lung cancer; however, these results became 

statistically non-significant once smoking was controlled 

for. Nevertheless, since it is important to control for 

exposure to other carcinogens when looking at the effects 

of radon on lung cancer. it was decided that this exposure 

could be best quantified as an index of total, cumulative 

years exposed to all the compounds considered. 

March 2008, Volume 94, Number 3 

Log-odds plots of the data suggested that there was 

a non-linear dose-response relationship between radon 

exposure and lung cancer. Therefore, radon exposure 

was considered as a categorical variable to allow for this 

potential non-linearity. In addition, radon exposure was 

modeled with a smooth function using natural cubic 

spline terms with two degrees of freedom (Hastie and 

Tibshirani 1990). Natural spline terms for radon exposure were obtained from the data set using the 'ns' 

function from the statistical package R (R Development 

Core Team 2005). Since neither analysis imposed a 

theoretical risk-vs.-exposure functional dependence, tbe 

data thus determined their own functional shape. For 

comparison, a fit to the LNT model was also calculated. 

RESULTS 

Summaries of demographics and radon-exposure for 

the 200 cases and 397 controls in the study are presented 

in Table I. Controls had a mean (SD) radon exposure rate 

of 66.3 (65.2) Bq m-3 and a median exposure of 50.1 Bq 

m- 3

• In contrast, cases had a mean (SD) and median 

radon exposure of 67.5 (118.5) Bq m -.land 43.7 Bq m -3

, 

respectively. However, one outlier among the cases was 

identified at 1,511 Bq m- 3 With this outlier removed, the 

mean (SD) and median for cases dropped to 60.2 (59.4) 

and 43.6 Bq m-3

, respectively, a difference that is 

statistically lower than that of the controls (p = 0.047 for 

means and p = 0.030 for medians via the Kruskal-Wallis 

test). This comparison of the simplest measure of exposure of cases and controls makes the possibility highly 

unlikely that these data are consistent with a linear 

increase in the risk of lung cancer with increasing radon 

exposure over the low dose region covered. Fig. l shows 

Controls 

600 800 0 400 600 BOO 

Radon (Bq m~) 

Fig. l. Distribution of radon exposures {Bq m ··>) by cases and 

controls. One outlier at 1,511 Bq m-• among the cases is not 

shown. 
384 


33371.359

Lung cancer risk from residential radon e R. E. THOMPSON ET AL 233 

the distribution of radon exposure for both cases and 

controls. 

Among the sample population, cases tended to have 

a marginally statistically shorter mean number of years 

of residency in their homes than controls [28.5 (12.1) vs. 

30.6 (12.1) y, p 0.049). Almost 42% of controls 

reported having at least some col1ege as compared to 

20% of cases, a difference that is highly significant (p < 

0.00 I). Controls had statistically significantly higher 

familv incomes than cases, with almost 48% of controls 

repor~ing household incomes greater than $30,000 y- 1 as 

opposed to 29% of cases in this income category (p < 

0.001 ). The percent of those who refused to give a 

household income was high for both groups (12% for 

controls and almost 17% for cases). A higher proportion 

of cases than controls also tended to have at least I 0 y of 

occupational exposure to potential carcinogens (21% vs. 

14%), an increase that is not statistically signitlcant (p = 

0.112). 

Not surprisingly, cases were much more likely to be 

current smokers than controls. Approximately 53% of 

cases reported that they were smokers at the time of 

interview, as compared to only 10% among the controls 

(p < 0.001). Similarly, only 7.5% of cases reported being 

never smokers as compared to almost 4 J% among the 

controls (p < 0Jl01). The proportion of former smokers 

was about equal between both groups ( 40% for cases and 

49% for controls). 

Table 2 shows the unadjusted ORs and corresponding 95% Cis for lung cancer and several predictor 

variables based on conditional logistic regression models. In this analysis, the radon variable was categorized 

into 6 exposure rate variables with the base category 

ranging from 0-<25 Bq m- 3

• Other break points, 50, 75, 

150, and 250 Bq m- 3

, were chosen to roughly equalize 

category populations. This univariate regression analysis 

revealed a significant decrease in cancer rates as radon 

exposure increased to about 150 Bq m-3

. In comparison 

to the lowest radon category, those with radon exposures 

in the 25-<50 50-<75, and 75-<150 Bq m- 3 categories have a statistically significant lower odds of cancer 

with deduced ORs (95% Cl) equal to 0.53 (0.32, 0.87), 

p = 0.012; 0.45 (0.26, 0.77), p = 0.004; and 0.44 (0.25, 

0.77), p 0.004, respectively. Study participants in the 

150-<250 Bq m-3 exposure category were half as likely 

to be cases as controls; however, this result is not 

Table 2. Unadjusted ORs (95% Cl) of cancer by radon exposure (as a categorical variable), smDking status, income, 

education, and total job exposure. 

Variable Cases/Controls 

Radon exposure (Bq m-'l 

<25 57170 

25-<50 601!27 

50-<75 34/89 

75-<150 34/86 

150-<250 8/18 

~250 717 

Smoking 

Never smoked 15/162 

Last smoked 3-5 20/13 

Last smoked y 22/lfi 

Last smoked 1 !-15 y !5/3! 

Last smoked > 15 y 23/136 

Smoker 5-30 pack~y 15112 

Smoker 30-50 pack~y 40/12 

Smoker 50-60 16/7 

Smoker 3418 

Income~($ 

!09/!59 

2.:30,000 58/!90 

EducatJon~ 

<High school 67177 

High school graJu<~te 90/149 

At least some college 40/165 

Tow! job exposure (y) 

0 1341290 

J-9 25152 

2.:10 4!/55 

'ORs and 959' .. CJs obtained from univariate conditional logistic regression. 11 Refusa!s removed. 

'p !S 0.1. 

dp !S 0.05 . 

• p !S 0.00!. 

Odds rntioa 

LOO 

0.53 

0.45 

0.44 

0.49 

1.20 

1.00 

17.66 

l9.SO 

6.12 

2.{)9 

10.75 

50.23 

49.26 

68.39 

l.OO 

lU7 

LOO 

0.66 

0.22 

1.00 

1.07 

1.74 

Reference 

Reference 

(0.23, 0.60)" 

Reference 

{0.43. LOI)' 

(0.13, 0.38)" 

Reference 

(O.ti3, l.Rl) 

(1.07, 2.82)~ 
385 


33371.360

234 Health Physics 

statistically significant [OR (95% CI) = 0.49 (0.19, 

1.28), p = 0.143]. The highest category of radon exposure (~250 Bq m-'') predicts an increase in the odds of 

cancer as compared to those in the base category, but the 

OR is not statistically significant [OR (95% Cl) = 1.20 

(0.40, 3.59), p = 0.746]. 

Initial regression analyses also revealed a decrease 

in the odds of cancer among former smokers as the time 

since cessation of smoking increased. Former smokers 

with 3 to 5 y and with 6 to lOy since quitting were 17.7 

and 19.5, respectively, times more likely to develop lung 

cancer as compared to the base group of never smokers, 

an increase that is highly statistically significant (p < 

0.001 for both groups). Those who last smoked 11 to 15 y 

prior to interview were only 6 times more likely to be 

cases compared to never smokers, a resnlt that is also 

highly significant [OR (95% Cl) = 6.12 (2.33, 16.11), 

p < 0.001]. Former smokers who had not smoked for at 

least 15 y had an estimated increase in cancer risk that is 

not statistically greater than for never smokers fOR (95% 

Cl) = 2.09 (0.92, 4.75), p = 0.078]. 

Among current smokers, there was dearly a trend 

toward increasing risk as the number of pack-years of 

smoking increased. For example, those with 5 to 30 

pack-years of smoking had an estimated 11-fold risk in 

cancer compared to never smokers fOR (95% Cl) = 

10.75 (3.53. 32.69), p < 0.001] while those with more 

than 60 pack-years of smoking had a cancer risk about 68 

times greater than the never smokers fOR (95% Cl) = 68.39 (21.80, 214.56), p < 0.001]. In fact, 34 of the 42 

participants with greater than 60 pack-years of smoking 

were cases, as compared to only 15 cases among the 177 

never smokers in the study. No current smokers reported 

less than 5 pack-years of smoking. 

Other factors that were statistically associated with 

cancer risk include education level, household income, 

and total years of job exposure to known or potential 

carcinogens. Those study pa11icipants who were high 

school graduates had two-thirds the risk of cancer as 

compared to those with less than a high school education, 

a difference that approaches statistical significance fOR 

(95% Cl) = 0.66 (0.43, 1.01), p = 0.057]. Pm1icipants 

with at least some college had an OR of0.22 (0.13, 0.38) 

of cancer. a decrease in risk that is highly significant 

(p < 0.001). Similarly, those with family incomes greater 

than $30,000 y- 1 had a highly statistically significant 

reduced cancer risk as compared to those making less 

than $30,000 y- 1 [OR (95% Cl) = 0.37 (0.23, 0.60), p < 

0.001]. In terms of occupational exposure, there was an 

almost two-fold cancer risk among those who were 

exposed to known or potential carcinogens for 10 or 

more years on the job as compared to those with no 

job-related exposure, an increase that is statistically 

March 2008, Volume 94, Number 3 

significant [OR (95% CI) = 1.74 (1.07, 2.82). p 

0.027]. Those with one to nine years of job-related 

exposure had no significant increased cancer risk when 

compared to those with no occupational exposure. 

Unadjusted ORs were calculated for the three cell 

types that together account for about three-quarters of the 

cases: adenocarcinoma (59 cases, 117 controls), small 

cell undifferentiated (44 cases, 87 controls). and squamous cell carcinoma (44- cases, 88 controls). The unadjusted ORs for adenocarcinoma were below unity with 

statistical significance between 50 and 150 Bq m-). For 

the five increasing exposure categories enumerated 

above, the ORs (95% Cl) were 0.53 (0.22, 1.25). p 

0.147; 0.28 (0.097, 0.82), p 0.020; 0.31 (0.11, 0.91), 

p = 0.032; 0.38 (0.059, 2.39), p = 0.30; 2.72 (0.23, 

31.5), p = 0.43. The unadjusted ORs for squamous cell 

carcinoma and small cell undifferentiated were without 

statlstical significance. 

Results from multivariable regression analyses are 

presented in Table 3. Two logistic multivariable models 

were considered: model 1 which categorized radon exposure into the six separate categories cousidered in the 

univariate logistic analyses, and model 2 in which radon 

exposure was fitted by natural cubic spline terms. Natural 

spline terms with between 2 and 4 degrees of freedom 

were considered (e.g., 1 to 3 knots) in order to give the 

regression model maximum flexibility to fit the data. 

Preliminary results revealed that varying the degrees of 

freedom produced overlapping curves and approximately 

equal fits to the data. Since spline terms with 2 degrees of 

freedom give a more parsimonious model than models 

incorporating terms with higher degrees of freedom. 

Table 3. AORs (95% Cl) by radon categories controlling for 

smoking, residency. job exposure, income, and education 

(model I). Model 2 gives AORs for continuous radon exposure 

modeled with natural cubic spline terms with 2 degrees 

of freedom." 

Radon expo~ure (Bq m-·') 

<25 

25-<50 

50-<75 

75-<150 

!50-<250 

2!250 

''Reference 4.4 Bq m-~. 

h 12.5 Bq m-1 v. 4.4 Bq m- 1

• 

'37.5 Bq m- 1 v. 4.4 Bq m- 1. 

u62.5 Bq m-e v. 4.4 Bq m-". 

¢ 112.5 Bq m _, v. 4.4 Bq rn"'. 1 200 Bq m-' v. 4.4 Bq m- 1. 

s 880.5 Bq m- 1 v 4.4 Bq m- 1. 

hp -:s O.L 

'p :S 0.05. 

Model I 

AOR (95% Cl) 

1.00 (Reference) 

0.53 {0.24. L! 3)h 

0.31 (0.13. 0.73)' 

0.47 (0.20, !.lO)h 

0.22 (0.04, LJ3)h 

2.50(0.47. !3.46) 

MDdel2 

AOR (95'X·Cll 

0.7:5 (0.:55, l.o3t 

039 (0.14. L07)h' 

0.35 (0.12. 1.04/'·" 

0.35 (0.13. 0.99)'' 

0.36 (0.!2. l.!O)td 

0.47 (0.11, 2.()4)~ 
386 


33371.361

Lung cancer risk from residential radon e R. E. THoMrsos ET A.L 235 

results using this fit are presented under model2 in Table 

3. The AORs for radon exposure under model 1 were 

calculated with <25 Bq m - 3 as the base category of 

comparison, while under model 2, 4.4 Bq m- 3 was used 

as the base of comparison to calculate the AORs at the 

midpoints of the model I radon categories. The value at 

4.4 Bq m -

3 was chosen as the base group in model 2 

since this was the lowest radon reading observed in this 

study. Under model I, those in the 50-<75 Bq m- 3 

category of radon exposure had roughly one-third the 

cancer risk of those in the under 25 Bq m -J category, a 

result that is statistically significant [AOR (95% Cl) = 

0.31 (0.13, 0.73), p = 0.008]. However, three other 

categories, 25-<50, 75-<150, and 150-<250 Bq m-· 3

, 

demonstrate a statistical trend toward a decreased risk, 

giving deduced AORs (95% Cl) of 0.53 (0.24, 1.!3), p = 0.099; 0.47 (0.20, 1.10), p 0.083; and 0.22 (0.04, 

1.13), p = 0.069, respectively. Those in the 2:250 Bq 

m-.l category had a 2.5-fold increase in cancer risk 

compared to the base group, but this increase is not 

statistically significant [AOR (95% Cl) = 2.50 (0.47, 

13.46), p 0.285]. There was less precision and hence a 

larger CI in the 2::250 Bq m -~exposure category because 

of a lack of cases and controls with high exposure values. 

Within the study population, only 14 (2.4%) participants 

were in the 2:250 Bq m - 3 category. 

Modeling radon exposure as a smooth function 

using natural cubic splines (model 2) produces ORs as a 

continuous function of exposure. Model 2 results presented in Table 3 are the values of the continuous 

function at the centers of the exposure categories. These 

results indicate a decreased cancer risk for those in the 

ci 

75-< 150 Bq m - 3 category as compared to the reference 

category that is marginally significant (p = 0.048). In 

addition, those in the 25-<50, 50-<75, and 150-<250 

Bq m - 3 categories have a decreased cancer risk that 

approaches statistical significance compared to the reference category with AORs that have associated p-values 

equal to 0.068, 0.058, and 0.078, respectively. Model 2 

deduced an AOR for subjects in the exposure category 

2:250 Bq m -3 that was less than one also, but with no 

significance [AOR (95% Cl) = 0.47 (0.11, 2.04), p 

0.312]. Fig. 2 shows the AORs, on the natural log scale, and 

associated 95% Cis for the discrete radon categories under 

model 1 as well as the continuous AORs (again on the 

natural log scale) obtained from model 2. A model 2 cUive 

using 3 degrees of freedom (not shown) closely follows the 

plotted 2 degrees of freedom cu1ve below 300 Bq m- 3 and 

then rises somewhat faster, being above 1 .0 at the last 

plotted discrete point l e.g., deduced AOR = 1.41 (0.06, 

34.23) at 880.5 Bq m-3

]. Model2 gives deduced AORs that 

are marginally statistically significant (0.048 s p s 0.05) in 

the region of radon exposure from about 85 to 123 Bq m -J 

Fig. 3 shows the continuous AORs and associated 95% Cis 

(dashed lines) obtained from model 2 for exposures below 

250 Bq m-3 on a linear scale. 

Multi variable regression analyses also revealed that 

income and occupational exposure are no longer significantly associated with cancer risk after controlling for 

education, smoking, and years of residency. However, 

there is a statistical trend towards an increased risk for 

those with lO y or more of job-related exposure (p s 

0.13) from both models I and 2. Education remains 

100 200 300 400 500 600 700 800 900 1000 

Radon (Bq m-3) 

Fig. 2. Plot of AORs and corresponding 95% Cis obtained from model 1 at the midpoint of exposure and continuous 

AORs obtained from model2. Odds ratios for model2 are normalized to 1.0 at 4A Bq m~'. the lowest observed radon 

exposure. 
387 


33371.362

236 Health Physics March 200S. Volume 94, Number 3 

~ ,---------------------------------------------, 

--------- ~ ~+-~-~-~----------~-~-~~----~------~=-~-~---_-__ -__________ _, ml 

"0 

-g 

"0 

.2, * "' ~ 0 \ -------------------j ' ', _________________________________ _ 

50 100 150 200 250 

Radon (Bq m·3) 

Fig. 3. Plot of AORs and corresponding 95% Cis (dash lines) obtained from model 2 for radon exposures less than 250 

Bq m-~. Odds ratios are normalized to 1.0 at 4.4 Bq m- 3

. 

statistically associated with cancer risk even after adjusting for the other covariates, with college-educated participants having approximately one-third the risk as 

compared to those with less than a high school education 

[AOR (95% Cl) = 0.30 (0.!3, 0.69), p 0.005, model I, 

and AOR (95% Cl) = 0.3! (0. !4, 0.69), p = 0.004, 

model 2]. Those who refused to give their education 

status and those with a high school degree had no 

statistically different cancer risk when compared to those 

with less than high school. AORs for the each of the three 

cell types discussed above were completely lacking in 

significance under either model 1 or 2. 

Because other studies of lung cancer risk vs. residential radon exposure, including the pooling study. have 

compared their data to the LNT model, a fit to that 

imposed model was calculated here. A positive slope 

(95% Cl), albeit statistically insignificant, of +0.04 

(-0.20, 0.35) per 100 Bq m- 3

, was found. The positive 

risk values at the higher exposure values pull the best-fit 

linear function upward in spite of the large horrnctic dip 

at the lower values. The likelihood ratio test was used to 

determine if the regression model 2 with natural spline 

term,<.; gives a superior fit to the data as compared to the 

linear modeL This test resulted in a marginally significant result (p = 0.0496) that corresponds in magnitude to 

the p-values associated with the AORs deduced from 

model 2. 

According to both models I and 2, the AOR per year 

of residency was very close to unity (0.99). This indicates 

that years of residency had little statistical effect on this 

study's deduced cancer risk. Nevertheless, admission of 

subjects with as little as 10 y of residency is a weakness 

of this study. To address this weakness, a sub-analy.sis of 

model l that included only subjects with at least 20 y of 

residency was performed. Because conditional logistic 

analysis was used, case-and-two-control triads were 

eliminated from the analyses if the case or both controls 

of the triad had a residency of less than 20 y. This cutoff 

at 20 y reduced the sample size from 597 to 348 subjects. 

Recalculating the univariate analysis of Table 2 with this 

data subset did not change the unadjusted ORs substantially but did, of course, expand the Cis because of the 

reduced statistical power. For comparison to Table 2, the 

new ORs and 95% Cis for the categories of increasing 

radon exposure were: 0.57 (0.31, 1.04), p 0.061:0.41 

(0.20, 0.83), p = 0.013; 0.54 (0.28, 1.05), p = 0.071: 

0.53 (0.!3, 2. 19), p 0.316; and 1.08 (0.21, 5.68). p 

0.926. 

When radon as a categorical variable was considered and covariates listed under model 1 controlled for in 

this sub-analysis, the AORs were greatly reduced for the 

25-<50 and 50-<75 Bq m _, categories of radon exposure as compared to the results presented in Table 3. 

Despite the reduced sample size, AORs for both categories were statistically tess than one. Those in the 25-<50 

Bq m- 3 category gave an AOR (95% Cl) = 0.24 (0.07, 

0.35),p = 0.027, while those in the 50-<75 Bq m- 3 had 

an AOR (95% Cl) 0.11 (0.02, 0.60), p = 0.0!1. The 

results for the 75-<150, 150-<250, and 2:250 Bq m"3 

radon categories also differ from the results presented in 

Table 3, with those in the 75-<150 and 150-<250 Bq 

m- 3 exposure categories having an increased risk, and 

those in the 2:250 Bq m -:> radon category having a 

decreased risk of cancer compared to the results using the 
388 


33371.363

Ltmg cancer risk from residential radon e R E, THOMPSON n AL. 237 

full data set. However, the AORs were not statistically 

different from one for any of these three categories in the 

sub-analysis, reflecting its loss of statistical power [AOR 

(95% CI) = 0.70 (0.21, 2.31), p = 0.564; AOR (95% 

Cl) = !.13 (0.06, 2!.62), p = 0.934: and AOR (95% 

Cl) = 0.73 (0.06, 8.99), p 0.804 for the 75-<150, 

150-<250, and ~250 Bq m-J radon categories, respectively]. While the complete loss of statistical significance 

in the three highest exposure categories is not surprising 

in view of the loss of 42% of the subjects in this 

sub-analysis, the lowering of the AORs in the lower two 

exposure categories and their increased statistical significance at being less than one is quite remarkable. These 

changes in AORs are difficult to explain given the nature 

of multivariable regression analyses. However, these 

results suggest the possibility that a greater nonlinear 

association between radon and cancer risk would have 

been seen if available resources had allowed for enrolling 

only subjects with a residency of ~20 y, as the Iowa 

study (Field et al. 2000) was able to do. 

A second alternative analysis based on model I was 

considered where radon exposure was calculated as a 

simple average of the living room and bedroom exposures, the "living area" exposure of the pooling study 

(Krewski et al. 2005, 2006), in contrast to the mobilityweighted average approach. Interestingly, with the exception of the highest radon exposure category of ~250 

Bq m -', this alternative model produced ORs adjusted 

for the covariates listed in Table 3 that were 26 to 38% 

larger than those obtained using the weighted average 

method. In addition, the p-values for the alternative 

AORs increased substantially in every categmy, with 

only the 50-<75 Bq m -J category retaining statistical 

significance [e.g., AOR (95% Cl) = 0.73 (0.35, 1.52), 

p 0.396; AOR (95% CI) = 0.39 (0.17, 0.91), p 

0.029; AOR (95% Cl) 0.59 (0.25, 1.38), p = 0.222; 

AOR (95% C!) = 0.30 (0.06, 1.59), p 0.157; and AOR 

(95% Cl) 2.20 (0.38, 12.77), p = 0.381 for the 

25-<50, 50-<75, 75-<150, 150-<250, and ~250 Bq 

m- 3 radon categories, respectively]. Note that in every 

category this less accurate measure of exposure caused 

the AORs to move closer to unity. that is, to blur out the 

functional dependence. Also. note that in all but the 

highest (and least significant) exposure category the 95% 

Cis increased from 23 to 40%, demonstrating that the 

pooling study measure of exposure produces a greater 

randomness or misspecification in the exposure values 

compared to the weighted average used in this study. 

Because of the substantial number of cases and 

controls that were interviewed by proxy (21.5% for 

cases. 3.3% for controls), a third sub-analysis was performed using only those data obtained from the participant interviews. The statistical results in the unadjusted 

case were unaffected by this analysis. However, in the 

multivariable model, the trends towards significance 

disappeared for radon categories less than 250 Bq m- 3

• 

but the deduced AORs for these categmies were still less 

than unity. A trend towards significance persisted in the 

~250 Bq m -J category, giving an AOR of 9.35 (p = 0.067) as compared to the reference category (model I). 

An investigation to understand this found only one thing: 

smokers interviewed by proxy had a statistically higher 

number of pack-years as compared to smokers interviewed in person. Whether this is proxy recall bias is 

unclear, and whether it alone could account for the loss 

of significance is also unclear. Of course, a lower 

statistical power from the loss of a quarter of the subjects 

could also contribute to the loss of statistical significance 

in the regression model. 

DISCUSSION 

The results of this study differ strongly from previous case-control studies concerning the risk of lung 

cancer from residential exposure to radon. The data here 

exhibit a striking protective or hermetic dip in the low 

dose rate region for both models 1 and 2. The four 

exposure categories between 25 and 250 Bq m- 3 have an 

average AOR of 0.38 for model I and 0.36 for model 2. 

The AOR is less than 1.0 with statistical significance for 

model I between 50 and 75 Bq m- 3 and with marginal 

statistical significance for model 2 between approximately gs and 123 Bq m- 3 (ranges below the EPA action 

level of 4 pCi L _, = 148 Bq m- 3

). This result was 

entirely unexpected. There have been many other reports 

in case-control studies of ORs below one in the low dose 

region but in all cases without statistical significance 

(Blot et al. !990; Letourneau eta!. 1994; Alavanja et al. 

1994, 1999; Auvinen et al. 1996; Kreuzer et al. 2003; 

Baysson et al. 2004: Wichmann et al. 2005: Sandler et al. 

2006). What reasons can be offered for this difference'' 

One important aspect of any radon study is careful 

dosimetry. Year-long measurements of radon with constant calibration of detectors using spikes, blanks, and 

duplicates are necessary. Equally important is the use of 

detectors in multiple house locations to account adequately for the subjects' mobility in the house. It is of 

great importance to determine this mobility, not just for 

the subjects' present lifestyle (full-time work, part-time 

work, retirement, child-rearing, etc.) but for all previous 

lifestyle periods in that house. This requires careful 

questioning of subjects and forming of doubly weighted 

averages. While this study was begun with this approach 

in 1990, more than a few studies performed since have 

not held to this standard. However, the Iowa study, the 

most elaborate one to date, did emphasize the importance 
389 


33371.364

238 Heillth Physics 

of this standard, but it did not find an OR dip below one 

(Fisher et a!. 1998; Field et al. 1998a and b, 2000). As a 

test of this measurement standard, the data were reanalyzed using simply the average of living area and 

bedroom detector readings as the measure of exposure, as 

in Krewski et al.'s pooling studies (Krewski et al. 2005, 

2006). There was a significant tendency for all OR values 

to move toward unity (from both above and below) and 

for Cis to enlarge and so remove statistical significance. 

One dosimetry difference of this study compared to the 

Iowa study should be noted. The high outdoor radon 

concentration in Iowa required assuming an exposure (35 

Bq m- 3

) of subjects outside their houses, while, as discussed above, radon concentrations in outdoor Worcester 

County air were sufficiently low (-10 Bq m _,) as to be 

ignored. 

Since cigarette smoking is known to be the dominant cause of lung cancer, at least ten times as lethal as 

radon as a national mortality cause, it is essential to 

account for it carefully. The year-by-year smoking his· 

tories of the subjects in this study (number and type 

smoked) were obtained from the interviews. This allowed exploring smoking in many statistical ways, leading to the use of nine smoking categories (Table 3) in our 

final analysis. Handling of this important confounder by 

considering both the duration and intensity of smoking 

among current :.;mokers and length of time since last 

smoked among former smokers is in line with previously 

published radon studies (e.g., Wichmann et a!. 2005; 

Krewski et al. 2005, 2006). 

Under all the models that were considered, both 

former and current smoking greatly increased the risk of 

cancer with a single exception: former smokers who 

reported not smoking for at least 15 y prior to entering 

into the study had only a slightly elevated risk of cancer 

compared to never smokers that was not statistically 

greater than one (Table 3 ). Another major finding that 

was consistent across all the models considered was that 

those with at least some college had approximately 

onc-lhird the risk of cancer as compared to those with 

less than a high school education. Whether this results 

from nature (genes) or nurture (healthier behavior) is 

unclear, but there is some indication of the latter. More 

highly educated people may have a healthier diet con· 

taining more anticarcinogens. This hypothesis is supported by findings in Italy which showed a marginally 

statistically significant reduced lung cancer risk of approximately one-third for those with a high consumption 

of carrots and tomatoes compared those with a low consumption of these vegetables (Bochicchio et al. 2005). A 

suggestion of reduced lung cancer risk with increased 

intake of vegetables, fruits, and juices was also reported 

for Missouri women (Wright et al. 2002). No significant 

March 2008, Volume 94. Number 3 

protective benefit for those with a high school degree, as 

compared to those with less education, was found. 

A rather unique aspect of this radon study design 

was use of the same health maintenance organization 

client pool (but not a hospital-based pool as in Baysson 

et al. 2004) for randomly choosing controls to be matched 

individually by age and sex to the cases. Because a 

control should be as identical as possible to its matched 

case (except, of course, for the presence of primary lung 

cancer), such a procedure should be superior to choosing 

the controls from the general population. This closer 

matching of cao;;es and controls can potentially adjust for 

confounders that are not easily quantified or adju,o;;ted for 

in a regression analysis. Compared to population-based 

recruiting, controls in this study came from a more similar 

socio-economic, geographic, and medical-care stratum of 

the population. How much difference can that make? The 

only way to answer that would be to recruit a new .set of 

400 controls matched to the 200 cases from the general 

population in Massachusetts and re-analyze the data. 

Unfortunately, resources are not currently available for 

such a study. 

Because our results contlict with the LNT hypothesis, it is worth reconsidering that issue. Its appeal 

originally stemmed from two ideas. First, a linear increase without a threshold requires but one parameter, a 

slope, and so is the simplest, nontrivial mathematical 

model. In the absence of further scientific information, 

this is naturally the preferred starting point. In time, a 

theoretical basis for the LNT hypothesis emerged; most 

cancers are monoclonal, and at typical residential exposures it is exceedingly unlikely that a lung cell will be 

struck twice by an alpha particle from radon and its 

progeny even in a person's lifetime. Doubling the exposure doubles the number of cells struck, and so doubles 

the chances of cancer. There is thus no basis for nonlinearity, and hence LNT is the logical conclusion (NRC 

1999). Such reasoning assumes that cells do not communicate with each other. However, the "bystander effect," 

where nearby cells "know" that a cell has been d<:~maged, 

is well established for in vitro cellular systems (Morgan 

and Sowa 20(l7). It undermines the theoretical reasoning 

for the linearity supporting LNT since nearby nontargeted cells could potentially experience either detrimental effects such as genetic damage (Morgan 2003) or 

non-detrimental effects such as a radio-adaptive response 

(lyer and Lehnert 2002). Nevertheless, the importance of 

the bystander effect as a modifier on radiation responses 

at the tissue and organ level and, by extrapolation, on 

human health is unclear (Morgan and Sowa 2007). In 

opposition to evidence supporting nonlinearity, however, 

a third support for LNT has now appeared: the pooling of 

seven studies (Krewski et al. 2005, 2006) finds a linear 
390 


33371.365

Lung cancer risk from residential rndon e R. E. T!lO'-fPSON f:.T AL. 239 

dependence of excess odds ratios [EOR (95% Cl) = 0.10 

(-0.01, 0.26) at 100 Bq m- 3

, p = 0.10]. 

So what can be made of this? First, it should be said 

that, although BEIR VI backs the LNT hypothesis. it 

acknowledges the bystander effect and states, "The 

committee acknowledged that other relationships [than 

LNT], including threshold and curvilinear relationships, 

cannot be exduded with complete confidence, particularly at the lowest levels of exposure" (NRC 1999). The 

Phase I study of BEIR VII (NRC 1998) states, "Enhanced expression of p53 [gene] has also been reported 

in bystander cells in cultures exposed to alpha rays" 

(Hickman et al. 1994), and then goes on to state, "The 

existence of inducible repair systems that improve the 

efficiency of DNA repair has fueled speculative proposals that low levels of ionizing radiation actually have 

beneficial, rather than deleterious, effects. These suggestions of hormesis in the radiation response must be 

considered seriously but critically." 

How could such nonlinear dependences-a hormetic 

dip, in this study- be missed in other case-control 

studies? One possible contributing effect would be that 

the reference category includes a substantial portion of 

those subjects that experience the protective effect. In 

that case. the reference category, normalized to OR I, 

would really contain a sizable population that properly 

belongs to OR < 1. An increa....;;e from such a reference 

category would be expected. For example, the high 

outdoor radon concentration in the Iowa study required 

using a reference category whose upper limit (corresponding to an average exposure rate of 58 Bq m- 1

) 

covers all of the radon exposure category used here that 

gave an AOR = 0.53 (model I) or 0.39 (model 2) and 

one-third of the next category used here that gave an 

AOR 0.31 (model 1) or 0.35 (model 2). The need for 

a substantial number of low-exposed subjects in order to 

detect hormesis has been emphasized in a recent review 

(Calabrese 2005). A second possible contributing effect 

is inadequate dosimetry, particularly in not accounting 

properly for in-house mobility and for its differences 

during earlier lifestyle periods. This could cause a blurring out of an OR dip before its inevit<Jble rise. The 

sub-analysis of this study using the simpler, pooledanalysis (Krewski et al. 2005, 2006) measure of radon 

exposure, discussed earlier, gives strong support to this 

conjecture. 

Though the Iowa study is the most rigorous and 

elaborate study reported to date, the recent pooled analysis of Krewski et al. (2006) should probably be regarded 

now as the standard of comparison. The present study has 

both similarities and differences with that pooling. Some 

basic measures of the studies' data are surprisingly 

similar: from tables 3 and 5 of Krewski et al. (2006), the 

mean of the mean values of radon exposures reported 

(SD) for all cases was found to be 69.8 (46.5) Bq m- 3 

while that of controls was higher at 71.1 (43.0) Bq m -.1. 

In the present study, the mean radon exposure of all cases 

was 60.2 Bq m -J (one outlier removed) while that of 

controls was higher at 66.3 Bq m -J. Also, the unadjusted 

ORs (95% Cl) calculated using 2-by-2 tables from data 

presented in table 9 of Krewski et al. (2006) yield: 0.80 

(0.71, 0.90), p < 0.001: 0.69 (0.60, 0.78), p < 0.001; 

0.75 (0.63, 0.88), p < 0.001: 0.90 (0.78, 1.05), p = 0.178; 0.77 (0.62, 0.96),p = 0.02; and 0.75 (0.61, 0.93), 

p = 0.008 for the categories 25-<50, 50-<75, 75-

<100, 100-<150, 150-<200, and <::200, respectively, 

all in Bq m- 3

• With the exception of the 100-<150 

category, all the unadjusted ORs were statistically less 

than 1.0. These values have their counterpart in the 

present study. For comparison on an equal footing 

[individual matching of cases and controls is not considered and radon exposure was detem1ined usinR the 

simple average living area measure as used in Krewski et 

al. (2006)], the unadjusted ORs (95% CI) of the present 

study were: 0.70 (0.45, 1.09), p = 0.113; 0.54 (0.32, 

0.92), p = 0.024; 0.52 (0.31, 0.88), p = 0.015; 0.59 

(0.22, 1.63),p = 0.311; and 1.19 (0.38, 3.7l),p 0.770 

for the categories 25-<50, 50-<75, 75-<150, 150-

<250, and <::250. respectively, all in Bq m - 3

• 

In spite of these similarities, after adjustment for 

confounders, this study and the pooling study arrive at 

strikingly different conclusions: this study finds a 

hormetic dip (AOR < 1.0) persists over a substantial 

range before a positive cancer risk begins to emerge at 

higher radon exposure levels; in contrast, the pooling 

study finds a positive cancer risk throughout the range. 

The methods useU for calculating the risk differ markedly: the present study fits cubic splines to the AOR data, 

letting the data determine the functional form: the pooling study tlts only to chosen functional dependences with 

the main emphasis on the LNT function. (A forced fit of 

the present study data to the LNT model also gives a 

positive slope, albeit statistically insignificant.) 

The confounders adjusted for in the final analyses of 

the two studies differ: the pooling study used age at 

diagnosis/enrollment, smoking categories. number of 

residences, and years of residence covered by alpha-track 

detector measurements; this study used smoking categories, education. and exposure to known or suspected 

carcinogens. The puzzle that needs to be answered then is 

how these differing adjustments lead to such different 

results for data sets that share similar simple hormetic 

measures of exposure. 

In addition, aspects of the study designs may be 

important. The pooling study is hindered somewhat by 

h<Jving to fmd a "lowest common denominator"' for the 
391 


33371.366

2-W Health Physics 

data of the seven studies, while the present study is not so 

affected. The present study used controls individually 

matched to cases, not frequency matching as most of the 

seven studies used .. The present study imputed no data 

while several of the seven studies used imputed exposure 

data. The present study used historic-mobility-weighted 

averages of exposure while the pooling was able to use 

only a "living area" measurement .. The present study 

matched controls to within :':2.5 y while the pooling 

study used :t5 y. All the seven pooled studies used 

population-based controls while the present study used 

controls from the clients of s<Jme he<Jith maintenance 

organization as the cases were from, giving presumably a 

better socio-economic, geographical, and medical-care 

stratum match to the cases .. Lastly, the present study used 

only face-to-face interviews for which 21 .. 5% of case 

interviews were surrogates, while the pooled study included a wider range of interview techniques and had 

44 .. 1% surrogates for case interviews .. It is hoped that this 

juxtaposition of both similarities and differences will 

help to resolve the puzzle posed above .. 

This p<~per's final conclusion: the possibility of a 

hormetic effect on lung cancer at low radiation doses 

cannot be excluded. 

Acknowledgments-This study was funded by the EPA for the detectors, 

the Fallon Foundation and the Fallon Community Health Plan for the field 

work, and the Worcester Polytechnic Institute and the St. Vincent Hospital 

Depilrtment of Medicine for the data analysis" We wish to acknowledge 

with great appreciation several people who contributed to this study: 

Stephen J. Weininger of Worcester Polytechnic Institute and Kenneth 

Kmnlund and Jane Lochrie of the FaHon Clinic, Worcester Medical Center, 

who contributed to the early phase of this work; Enrique Soto of St. 

Vincent Hospital. Worcester Medical Center, who confirmed the pathology 

of the lung cancer patients: Susan CDnrath of the Radon Office of the EPA 

who ftlrnished the detectors; S .. W_ Poppel1, Rhonda S .. Cook, and David J. 

Gray of the EPA National Air and Radiation Environme'ntal Laboratory in 

Montgomery, AL, for producing the detectors with calibrated exposures; 10 

Elizabeth Johnson for her assistance with the statistical analyses; to Amy 

H. Thompson for her editorial suggestions; to Stuart L. Shalat for 

contributing to the study design; to the many field workers for gathering 

data; and especially to the many lung cancer patients, their matched 

('Ontrols, and their approving physicians who volunteered their time and 

cooperation to make this study possible, 

REFERENCES 

Alavanja MCR, Brownson RC, Lubin JH, Berger E, Chang J, 

Boice JD Jr. Residential radon exposure and lung cancer 

among nonsmoking women. J Nat Cancer Inst 86:1829-

1837; 1994. 

Alavanja MCR, Lubin JH, Mahaffey JA, Brownson RC 

Residential radon exposure and risk of lung cancer in 

Missouri. Am J Public Health 89: I 042-l 048; 1999. 

Auvincn A, Makelainen I, Hakama M, Castren 0, PukkaJa E, 

Reisbacka H, Rytomaa T .. Indoor radon exposure and risk of 

lung cancer: a nested case-control study in Finland .. J Nat 

Cancer lnst 88:966-972; 1996. 

March 2008, Volume 94, Number 3 

13aysson H, Tirmarche M, Tymen G, Gouva S. Cail!aud D, 

Artus JC, Vergnenegre A, Ducloy F, Laurier D. Indoor 

radon and lung cancer in France .. Epidemiol 15:709-716; 

2004. 

Blot WJ, Xu ZY, Boice JD Jr, Zhao DZ, Stone BJ, Sun J, ling 

L-B, Fraumeni JF Jr. Indoor radon and lung cancer in China, 

J Nat Cancer lnst 82: 1025-1030; 1990. 

Bochicchio F, Forastiere F, Farchi S, Quarto M, Axelson 0. 

Residential radon exposure, diet and lung cancer: a casecontrol study in a Mediterranean region. Int J Cancer 

ll4:983-·991; 2005. 

Calabrese El Paradigm lost, paradigm found: the reemergence of hormesis as a fundamental dose response 

model in the toxicological sciences, Environ Pollut 1 38: 

378-411; 2005. 

Cohen BL Test of the linear-no threshold theory of radiation 

carcinogenesis for inhaled radon decay products. Health 

Phys 68:157-174; 1995. 

Cohen BL. Lung cancer rate vs .. mean radon level in V.S, 

counties of various characteristics .. Health Phys 72:114--

1 19; 1997. 

Darby S, Hill D, Auvinen A, Barros-Dios JM, Baysson H, 

Bochicchio F, Deo H, Falk R, Forastiere F, Hakama M, 

Heid I, Kreienbrock L, Kreuzer M, Lagarde F, Makelainen 

I, Muirhead C. Oberaigner W, Pershagen G, Ruano-Ravina 

A, Ruosteenoja E, Schaffrath Rosario A, Tirmarche M, 

Tomasek L, Whitley E, Wichmann H-E, Doll K Radon in 

homes and risk of lung cancer: collaborative analysis of 

individual data from 13 European case-control studies, BMJ 

330:223-228; 2005. 

Field RW, Lynch CF, Steck OJ, Fisher EL. Dosimetry quality 

assurance: Iowa residential radon lung canc~r study. Radiat 

Protect Dosim 78:295-303; 1998a. 

Field RW, Smith BJ, Brus CP. Lynch CF. Neuberger IS, Steck 

DJ .. Retrospective temporal and spatial mobility of adult 

Iowa women. Risk Anal 18:575-584; 1998b. 

Field RW, Steck OJ, Smith BJ, Brus CP, Fisher EL, Neuberger 

JS, Platz. CE, Robinson RA, Woolson RF, Lynch CF .. 

Residential radon gas exposure and lung cancer; the Iowa 

radon lung cancer study. Am J Epidemic! 151:!091--1 102: 

2000. 

Fisher EL, Field RW, Smith BJ, Lynch CF, Steck OJ, 

Neuberger JS. Spatial variation of residential radon 

concentrations: the Iowa radon lung cancer study .. Health 

Phys 75:506-513; 1998. 

Hastie TJ, Tibshirani R.I. General additive models, Boca Raton: 

Chapman and Hall/CRC; 1990. 

Hickman AW, Jaramillo RJ, Lechner JF, Johnson NF .. Alpha 

particle-induced p53 protein expression in a rat lung epithelial cell strain .. Cancer Res 54:5797-5800; 1994. 

Iyer R, Lehnert BE. Low dose, low-LET ionizing radiationinduced radioadaptation and associated early responses in 

unirradiatcd cells, Mutat Res 503:1-9; 2002. 

Kreuzer M, Hcimich J, Wolke G, Schaffrath Rosario A, Gerken 

M, Wellmann J, Keller G, Kreienbrock L, Wichmann HE. 

Residential radon and risk of lung cancer in Eastem Germany. 

Epidcmiol 14:559-568; 2003. 

Krewski D, Lubin JH, Zielinski JM, Alavanja M, Catalan 

VS, Field RW, Klotz JB, Letourneau EG, Lynch CF. 

Lyon ..II, Sandler DP, Schoenberg JB, Steck OJ, Stolwijk 

JA, Weinberg C, Wilcox HB .. Residential radon and risk 

of lung cancer: a combined analysis of 7 North American 

case~control studies .. Epidemiol 16:137-145; 2005. 

Krewski D, Lubin JH, Zielinski JM, Alavanja M, Catalan 

VS. Field RW, Klotz JB, Letourneau EG, Lynch CF, 

Lyon JI, Sandler DP, Schoenberg Jl3, Steck OJ, Stolwijk 
392 


33371.367

Lung cancer risk from residential radon e R. E. THOMPSON 24! 

JA, Weinberg C, Wilcox HB. A combined analysis of 

North American case~control studies of residential radon 

and lung cancer. J Toxicol Environ Health A 69:533-

597; 2006. 

Letourneau EG, Krewski D, Chol NW, Goddard MJ, McGregor 

RG, Zielinski JM, Du J. Case-control study of residential 

radon and lung cancer in Winnipeg, Manitoba, Canada. 

Am J Epidemiol 140:310-322; 1994. 

Lubin JH. Studies of radon and lung cancer in North America 

and China. Radial Prot Dosim 104:315-319; 2003. 

Lubin JH, Wang ZY, Boice JD Jr. Xu ZY, Blot WJ, De Wang 

L, Kleinerman RA. Risk of lung cancer and residential 

radon in China: pooled results of two studies. lnt J Cancer 

109:132-137; 2004. 

Morgan WF. Non-targeted and delayed effects of exposure to 

ionizing radiation: I. Radiation-induced genomic instability 

and bystander effects in vitro. Radiat Res 159;567-580; 2003. 

Morgan WF, Sowa MB. Non-targeted bystander effects induced by ionizing radiation. Mutat Res 616: 159-164; 2007. 

National Research CounciL Health effects of exposure to low 

levels of ionizing radiations: time for reassessment? BEIR VIL 

Committee on Health Risks of Exposure to Radon, Board on 

Radiation Effects Research, Commission on Life Sciences. 

Washington, DC: National Academy Press 23; 1998. 

National Research CounciL Health effects of exposure to 

radon, BEIR VI. Committee on Health Risks of Exposure to 

Radon. Board on Radiation Effects Research. Commission 

on Life Sciences. Washington, DC: National Academy 

Press: 6, 49, App. G; 1999. 

Pavia M, Bianco A, Pileggi C, Angelillo lF. Meta-analysis of 

residential exposure to radon gas and lung cancer. Bull 

World Health Org 81:732-738; 2003. 

R Development Core Team, R: a language and environment for 

statistical computing. Vienna: R Foundation for Statistical 

Computing; 2005. Available at: http://www.r·project.org/. 

Accessed October 2006. 

Rosner B. Fundamentals of biostatistics. Pacific Grove, CA: 

Duxbury; 2000. 

Sandler DP, Weinberg CR, Shore DL, Archer VE, Stone MB. 

Lyon JL, Rothney-Kozlak L, Shepherd M, Stolwijk JAJ. Indoor radon and lung cancer risk in Connecticut and Utah. 

J Toxicol Environ Health A 69:633-654; 2006. 

Smith JM, Poppell SW, Singletary HM. Clark AP, Shue SL A 

summary of the national radon measurement proficiency 

program and associated test facilities. Radiat Protect Dosim 

45:61-64; 1992. 

Stata Corp. Stata Statistical Software: Release 8.0. College 

Station, TX: Stata Corp; 2003. 

U.S. Environmental Protection Agency. Assessment of ri!:iks 

from radon in homes. Wa.'ihington, DC: Office of Radiation 

and Indoor Air, U.S. EPA; 2003. 

Wichmann HE, Schaffrath Rosario A, Heid JM, Kreuzer M, 

Heinrich J, Kreienbrock L. Increased lung cancer risk due to 

residential radon in n pooled and extended analysis of 

studies in Germany. Health Phy.s 88:71-79: 2005. 

Wright ME, Mayne ST. Alavanja MCR. Low fruit and vege~ 

table intake exacerbates the risk of lung cancer associated 

with residential radon exposure. J Nutr l32:3542S; 2002 . 

•• 
393 


33371.368

STATEMENT FOR THE RECORD 

BY 

THE NATIONAL STONE, SAND & GRAVEL ASSOCIATION 

66 Canal Center Plaza, Suite 300 

Alexandria, VA 22314 

703.525.8788 

SUBMITTED TO THE 

COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS 

SUBCOMMITTEE ON SUPERFUND, WASTE MANAGEMENT, 

AND REGULATORY OVERSIGHT 

UNITED STATES SENATE 

"OVERSIGHT OF THE ENVIRONMENTAL PROTECTION AGENCY'S 

IMPLEMENTATION OF 

SOUND AND TRANSPARENT SCIENCE IN REGULATION." 

OCTOBER 3, 2018 
394 


33371.369

U.S. Senate/ Committee on Environment and Public Works 

October 3, 2018 

Page 2 

Chairman Barrasso, Ranking Member Carper, and other members of the Environment & Public Works Committee: 

The National Stone, Sand and Gravel Association (NSSGA) appreciates the 

opportunity to submit a statement for the record of this Committee hearing and to address 

the importance of transparency in regulatory science. 

Aggregates and the Economy 

NSSGA (www.nssga.org) is the leading voice and advocate for the construction 

aggregates industry. NSSGA advances public policies that protect and expand the safe, 

environmentally responsible use of aggregates that build America's infrastructure and 

economy. NSSGA members-stone, sand & gravel producers and the equipment 

manufacturers and service providers who support them-supply the essential raw 

materials found in every home, building, road, bridge and public works project. The 

industry employs more than 100,000 highly-skilled men and women at 5,000 separate 

worksites, in all 50 states. Our members are committed to maintaining a sustainable 

environment for all, and to providing a safe and healthful work environment for their 

employees, whose daily efforts in today's economy provide vital support to their families 

and the communities in which they live. 

The Need for Transparency in Regulatory Science 

The aggregates industry is not opposed to sensible, evidence-based regulations. Our 

members are directly impacted by the Agency's regulations under a host of federal statutes. 

We believe that the foundations of the regulatory process will be immensely strengthened, 

and its benefits greatly increased, when the underlying models, assumptions, methods, and 

data that support regulatory research findings are made publicly available in a manner that 

is sufficient to permit independent validation. 

We salute the leadership shown by the Environmental Protection Agency (EPA) in 

clarifying and proposing to codify the bedrock principles for scientific inquiry that led to a 

host of valid discoveries and beneficial action, but which have been deteriorating in the U.S. 

over time. The Agency should be congratulated for a sound and useful model that all federal 

and state regulatory bodies and research entities should emulate. 

First and foremost, the Agency should continue to endeavor to ensure that the 

research methods and findings it relies on will pass rigorous scientific and legal review. 
395 


33371.370

U.S. Senate/ Committee on Environment and Public Works 

October 3, 2018 

Page 3 

This concept has been recognized for decades in the courts and in many other contexts. The 

limitations of such reviews are now well documented, but they still provide a useful firststep toward valid science. 

Tremendous environmental progress in the U.S. has been made in the last five 

decades. The Agency should be credited for its role in changing not only the state of the 

environment but also the way Americans think about the air, water, and land we all share. 

Much environmental progress to date, however, has represented the "low-hanging 

fruit." We are now in a time when many regulations depend on complex, assumption-laden 

mathematical models or constructs and ambiguous data sets-all of which are open to 

various interpretations. At the same time, no attempt is made to replicate the majority of 

peer-reviewed scientific papers and, indeed, many or most cannot be replicated when such 

attempts are made. Research findings from numerous scientific disciplines are affected. 

Society's need for a healthy environment must consider the needs of all those 

affected by its regulations. A transparent regulatory process-informed by accessible, 

reproducible scientific methods, data, and findings-provides the best opportunity for 

achieving both imperatives. That is particularly true considering the deference that courts 

provide to regulators' choices of research methods and models. Petitioners today cannot 

rely on the courts to question an agency's regulatory processes or conclusions, no matter 

how opaque, irreproducible, speculative, or erroneous their scientific foundation. 

EPA's proposal recognizes and catalogs ample convincing evidence that the Agency's 

present rulemaking process is inadequate and should be modernized. The proposal lays out 

sensible and thoughtful steps that will vastly improve the scientific basis for technical 

regulations. Importantly, many of the ideas embodied in the proposal originated primarily 

outside the Agency before the current administration took office. 

The proposal's objectives are consistent with EPA's authority under the numerous 

environmental statutes that it implements, which emphasize the need for regulatory 

decisions to be guided by sound science and informed public participation while also 

recognizing the need to protect important privacy interests. For example, the Toxic 

Substances Control Act ("TSCA") requires EPA to make regulatory decisions based on the 

"best available science," including the "degree of clarity and completeness with which the 

data, assumptions, methods, quality assurance, and analyses employed to generate the 

information are documented." At the same time, TSCA recognizes the importance of certain 

privacy interests, such as protecting confidential business information and private personal 
396 

Æ 


33371.371

U.S. Senate/ Committee on Environment and Public Works 

October 3, 2018 

Page 4 

information. Clearly, EPA must ensure that any final action it takes on this proposal 

continues to respect the balance between sound, transparent science and legitimate 

privacy interests. 

Mr. Chairman, NSSGA thanks you for holding this very important hearing. NSSGA 

looks forward to continuing to work with the committee in doing what is right for America. 

If we ignore or sideline this opportunity to strengthen the science that strengthens the 

Nation's regulations, we put the future of our society at unnecessary and avoidable risk.