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AGENCY USE OF SCIENCE IN THE RULEMAKING 

PROCESS: PROPOSALS FOR IMPROVING 

TRANSPARENCY AND ACCOUNTABILITY 

HEARING 

BEFORE THE

SUBCOMMITTEE ON 

REGULATORY AFFAIRS AND FEDERAL 

MANAGEMENT 

OF THE

COMMITTEE ON 

HOMELAND SECURITY AND 

GOVERNMENTAL AFFAIRS 

UNITED STATES SENATE 

ONE HUNDRED FIFTEENTH CONGRESS 

FIRST SESSION 

MARCH 9, 2017 

Available via http://www.fdsys.gov 

Printed for the use of the Committee on Homeland Security 

and Governmental Affairs 

( 
(II) 

COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS 

RON JOHNSON, Wisconsin, Chairman 

JOHN MCCAIN, Arizona 

ROB PORTMAN, Ohio 

RAND PAUL, Kentucky 

JAMES LANKFORD, Oklahoma 

MICHAEL B. ENZI, Wyoming 

JOHN HOEVEN, North Dakota 

STEVE DAINES, Montana 

CLAIRE MCCASKILL, Missouri 

THOMAS R. CARPER, Delaware 

JON TESTER, Montana 

HEIDI HEITKAMP, North Dakota 

GARY C. PETERS, Michigan 

MAGGIE HASSAN, New Hampshire 

KAMALA D. HARRIS, California 

CHRISTOPHER R. HIXON, Staff Director 

MARGARET E. DAUM, Minority Staff Director 

LAURA W. KILBRIDE, Chief Clerk 

SUBCOMMITTEE ON REGULATORY AFFAIRS AND FEDERAL 

MANAGEMENT 

JAMES LANKFORD, Oklahoma, Chairman 

JOHN MCCAIN, Arizona 

ROB PORTMAN, Ohio 

MICHAEL B. ENZI, Wyoming 

STEVE DAINES, Montana 

HEIDI HEITKAMP, North Dakota 

THOMAS R. CARPER, Delaware 

MAGGIE HASSAN, New Hampshire 

KAMALA D. HARRIS, California 

JOHN CUADERESS, Staff Director 

JAMES MANN, Professional Staff Member 

ERIC BURSCH, Minority Staff Director 

WARREN FLATAU, Minority Legislative Fellow 

KATIE DELACENSERIE, Subcommittee Clerk and Committee Archivist 
(III) 

C O N T E N T S 

Opening statement: Page 

Senator Lankford .............................................................................................. 1 

Senator Heitkamp ............................................................................................ 8 

Senator Hassan ................................................................................................. 9 

Senator Harris .................................................................................................. 11 

Senator Daines ................................................................................................. 16 

Senator Carper ................................................................................................. 23 

Prepared statement: 

Senator Lankford .............................................................................................. 35 

Senator Heitkamp ............................................................................................ 37 

WITNESSES 

THURSDAY, MARCH 9, 2017 

Susan Dudley, Director, Regulatory Studies Center, The George Washington 

University ............................................................................................................. 3 

Andrew A. Rosenberg, Ph.D., Director, Center for Science and Democracy, 

Union of Concerned Scientists ............................................................................ 5 

Nancy Beck, Ph.D., Senior Director, Regulatory Science Policy, American 

Chemistry Council ................................................................................................ 7 

ALPHABETICAL LIST OF WITNESSES

Beck, Nancy, Ph.D.: 

Testimony .......................................................................................................... 7 

Prepared statement .......................................................................................... 56 

Dudley, Susan: 

Testimony .......................................................................................................... 3 

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

Rosenberg, Andrew A., Ph.D.: 

Testimony .......................................................................................................... 5 

Prepared statement .......................................................................................... 49 

APPENDIX 

Article submitted by Senator Harris ...................................................................... 74 

Responses to post-hearing questions for the Record from: 

Ms. Dudley ........................................................................................................ 77 

Mr. Rosenberg ................................................................................................... 81 

Ms. Beck ............................................................................................................ 85 

(1) 

1The prepared statement of Senator Lankford appears in the Appendix on page 35. 

AGENCY USE OF SCIENCE IN THE 

RULEMAKING PROCESS: PROPOSALS FOR 

IMPROVING TRANSPARENCY AND 

ACCOUNTABILITY 

THURSDAY, MARCH 9, 2017 

U.S. SENATE,

SUBCOMMITTEE ON REGULATORY,

AFFAIRS AND FEDERAL MANAGEMENT,

OF THE COMMITTEE ON HOMELAND SECURITY

AND GOVERNMENTAL AFFAIRS, 

Washington, DC. 

The Committee met, pursuant to notice, at 10:15 a.m., in room 

342, Dirksen Senate Office Building, Hon. James Lankford, Chairman of the Subcommittee, presiding. 

Present: Senators Lankford, Daines, Heitkamp, Carper, Hassan, 

and Harris. 

OPENING STATEMENT OF SENATOR LANKFORD1

Senator LANKFORD. Good morning. Welcome to today’s Subcommittee hearing entitled Agency Use of Science in the Rulemaking Process: Proposals for Improving Transparency and Accountability. 

Over 2 years ago, this Subcommittee began an in-depth review 

of the rulemaking process, tackling subjects such as retrospective 

review, agency use of guidance, and issues surrounding small business’ concerns when it comes to improving the regulatory outcomes. 

This morning we will continue our regulatory work by examining 

how agencies use scientific information to inform their regulatory 

decision making. 

American people should be confident that when agencies regulate 

they are relying on up-to-date, accurate, and unbiased information. 

To put it simply, agencies should rely on the best available information and make decisions based on the weight of that information. 

When determining whether scientific information is the best 

available, agencies should consider things like whether information 

has been peer-reviewed by an independent third party, whether the 

conclusions are verifiable and reproducible, whether the information’s use is consistent with its intended purpose, and whether the 

data is transparent and publicly available. 
2 

This is not a new idea. Presidents from both parties have 

stressed the importance of relying on sound science to inform regulatory decisions. Executive Order (EO) 12866, which has been in 

place since 1993, and endorsed by every President since, directs 

agencies to base decisions on the best reasonably obtainable, scientific and technical information. Eight years ago, President 

Obama went even further by issuing a memorandum to agency 

heads guaranteeing scientific integrity by following a list of principles that included consideration of well-established scientific processes and urging transparency to the public. And in 2011, President Obama issued Executive Order 13563, where he directed each 

agency to ensure the objectivity of any scientific and technical information used to support regulatory actions. 

Yet, despite these clear directives, agencies continue to use questionable science to support their regulatory decisions, or we do not 

know the background on science. For example, in 2015, when the 

Environmental Protection Agency (EPA) proposed a ban on 

chlorpyrifos, an insecticide that farmers have been using successfully for decades, the agency based the regulation on a study that 

was discredited by their own scientific advisory panel and by the 

U.S. Department of Agriculture (USDA). 

I understand agencies often face difficult choices and not all 

studies come to the same conclusion, but it is very concerning when 

agencies are not open about why they chose to use a study with 

such significant criticism. When agencies hide information from 

both Congress and the American people, it is our job to question 

motives and methods as a part of oversight. 

Transparency is not an unreasonable request. In fact, it will go 

a long way in enforcing better regulations and heading off lawsuits 

in the future. When agencies issue regulations that place legally 

binding requirements on the American people, the data and methods or models the agency used should be publicly available for independent, third-party review. 

When many of the most costly Clean Air Act (CAA) regulations 

are based on a single Harvard study from 1993, EPA should not 

be able to hide behind the excuse they can’t release the study because they do not own it, Harvard does, despite the fact that Harvard receives well over half a billion dollars in Federal awards. 

Examples like these call into question whether agencies are 

using best information because it is unknown, not because there is 

just a false accusation. We just don’t know, and the American people do deserve to be able to know when these things impact their 

lives in such a significant way. 

Each administration has their own priorities, but the principles 

supporting regulatory decisions should remain constant, regardless 

of who occupies the White House. If past administrations’ attempts 

to encourage agencies to base their regulatory decisions on transparent, sound science have failed, Congress should consider establishing new legal requirements. 

I look forward to discussing steps Congress can take to implement basic, fundamental requirements that have been endorsed by 

both Democrat and Republican administrations for decades. 

Senator Heitkamp is running a little bit behind, though I will always tease her and say the lady is never late, but I will recognize 
3 

1The prepared statement of Ms. Dudley appears in the Appendix on page 38. 

her for an opening statement if she chooses to give that orally, or 

to be able to put that into the permanent record if she does not 

choose to. 

With that I would like to recognize our witnesses. Let me introduce them all and then we will do a swearing-in, and then we will 

take your testimony. 

The Hon. Susan Dudley is the Director of the Regulatory Studies 

Center and Distinguished Professor of Practice in the Trachtenberg 

School of Public Policy and Public Administration, George Washington (GW) University. Before joining the faculty at GW, she 

served as the Administrator of the Office of Information and Regulatory Affairs (OIRA), from 2007 to 2009. Thanks for being here. 

Dr. Andrew Rosenberg is the Director of the Center for Science 

and Democracy at the Union of Concerned Scientists. Before joining the Union of Concerned Scientists, he served as the Northeast 

Regional Administrator of the National Marine Fisheries Service 

(NMFS) at the National Oceanic and Atmospheric Administration 

(NOAA). Thanks again. 

Dr. Nancy Beck is a senior director of Regulatory and Science 

Policy at the American Chemistry Council (ACC). Prior to joining 

the ACC she served as a toxicologist and science policy analyst at 

the Office of Management and Budget (OMB’s) Office of Information and Regulatory Affairs from 2002 to 2012. 

I do thank all of the witnesses for appearing. 

It is our custom, as a Subcommittee and as a committee, to 

swear in all witnesses, so if you would all please rise and raise 

your right hand. 

Do you swear the testimony you will give before this committee 

will be the truth, the whole truth, and nothing but the truth, so 

help you, God? 

Ms. DUDLEY. I do. 

Mr. ROSENBERG. I do. 

Ms. BECK. I do. 

Senator LANKFORD. Thank you. You may be seated. Let the 

record reflect the witnesses have all answered in the affirmative. 

We do use a timing system here. That would be a 5-minute time 

clock that will start in front of you, countdown for your opening 

statements. Obviously all of your written statements will go into 

the permanent record already, and so we are welcome to be able 

to receive your oral testimony. 

Susan Dudley, you are up first. 

TESTIMONY OF SUSAN DUDLEY,1 DIRECTOR, REGULATORY 

STUDIES CENTER, THE GEORGE WASHINGTON UNIVERSITY 

Ms. DUDLEY. Thank you very much, Chairman Lankford, and it 

is good to meet you, Senator Hassan. 

Effective regulatory policy that focuses resources on addressing 

real threats to public health and the environment depends on reliable scientific information and transparent policy choices, so your 

hearing is important. 

I do not think anyone wants science to be politicized, but no one 

is immune to the temptation to put a spin on science to advance 
4 

a policy goal. Politicization can arise when political decisionmakers 

attempt to distort scientific findings, but also when scientists and 

others attempt to exert influence on policy decisions by how they 

present scientific information. 

My prepared testimony focuses on the second type of 

politicization. It identifies two problems that current regulatory institutions tend to aggravate. The first is when scientists, intentionally or not, insert but do not disclose their own policy preferences in the scientific advice they provide decisionmakers. I have 

called this ‘‘hidden policy judgments’’ and others have called it ‘‘advocacy science’’ or ‘‘normative science.’’ The second problem is the 

tendency to camouflage controversial policy decisions as science. 

For this I adopt Wendy Wagner’s colorful term, a ‘‘science charade.’’ 

Institutional arrangements tend to aggravate both the hidden 

policy judgments and science charades, which threaten the credibility of science and harm regulatory policy. Many of those involved 

in regulatory decisions have incentives to hide policy preferences, 

such as how to deal with uncertainty inherent in assessments of 

risk, and to dismiss, and even denigrate dissenting views. Key policy choices, disguised as science, too often rest with technical staff, 

while policymakers are able to avoid responsibility by claiming that 

their hands were tied by the science. 

In thinking about reforms to improve how science is used in regulation, clarifying which aspects of the decision are matters of 

science and which are matters of policy is essential to avoid both 

hidden policy judgments and the science charade. This was a key 

finding of a 2009 Bipartisan Policy Center (BPC) report, as well as 

a 1983 National Research Council (NRC) book. 

In a forthcoming paper, Marcus Peacock and I offer 10 recommendations. I boiled those down to eight in my written testimony, and will trim them down to five for the remaining few minutes that I have. 

First, we must recognize that science is a positive discipline that 

can inform, but not decide, appropriate policy. In drafting authorizing legislation, Congress should not delegate decisions to agencies 

on the pretense that science alone can make the normative decision 

of what policy ought to be. 

Second, science advisory panels can provide a necessary and valuable source of information and peer review for agencies, but greater efforts should be made to restrict their advice to matters of 

science and not ask them to recommend policy. Further, a 2012 

Keystone Center report emphasized all potential panelists on those 

science advisory boards will have conscious and unconscious biases, 

so it is important to select panelists with diverse perspectives and 

expertise, who are willing to engage in open discussion and are 

open to considering other views. 

Third, risk assessments necessarily involve assumptions and 

judgments as well as pure scientific inputs, yet they often generate 

precise-sounding predictions that hide not only considerable uncertainty about actual risk but hidden judgments. Greater transparency regarding the assumptions and policy rationales for choosing one set of assumption or models over another would encourage 

more openness and constructive discussion about science and policy. 
5 

1The prepared statement of Mr. Rosenberg appears in the Appendix on page 49. 

Fourth, reproducibility is important and it requires sharing of 

underlying data. I understand and appreciate concerns about disclosure of personally identifiable information (PII) and confidential 

information, but many Federal agencies have successful guidelines 

allowing access to data containing PII, using tiered approaches 

commensurate with the sensitivity of the information. 

And finally, the scientific method depends on falsifiable 

hypotheses, data gathering, replication, dissent, and challenge—Reforms that intentionally engage rather than avoid competing views 

and that subject scientific predictions to ex-post evaluation would 

go a long way toward improving underlying science and the decisions that depend on it. 

Legislation both Senators Lankford and Heitkamp have introduced, could be constructive. One bill that you introduced just yesterday would require advanced notices of proposed rulemaking for 

high-impact regulations, and one that you introduced together last 

session, would have required agencies to plan for ex-post review 

when proposing new rules, and that provides that feedback. 

So I will close there, and thank you again for inviting me. 

Senator LANKFORD. Thank you. Dr. Rosenberg. 

TESTIMONY OF ANDREW A. ROSENBERG, PH.D.,1 DIRECTOR, 

CENTER FOR SCIENCE AND DEMOCRACY, UNION OF CONCERNED SCIENTISTS 

Mr. ROSENBERG. Chairman Lankford, Senator Hassan, Members 

of the Subcommittee, and Ranking Member Heitkamp, thank you 

for the opportunity to testify today on the important role of science 

and rulemaking process. 

I am Andrew Rosenberg, Director of the Center for Science and 

Democracy at the Union of Concerned Scientists, and I have more 

than 25 years of experience as a scientist in government service, 

academia, and the private sector. I have served as a scientist and 

regulator in Democratic and Republican administrations, including 

as Deputy Director of NOAA Fisheries, as you noted. And in academia, I was the Dean of Life Sciences and Agriculture at the University of New Hampshire. 

Independent science plays a critical role in the policy decisions 

made by the Federal Government that impact Americans’ health 

and safety, and the science process consists of continuous and incremental discoveries in multiple fields of study, accumulating a 

weight of evidence and building toward broad acceptance of facts 

within the scientific community. 

Weight of evidence refers to the cumulative body of scientific research and analysis that pertains to a particular subject. Weight 

refers not only to the number of studies but also their importance, 

robustness, and credibility in drawing scientific inference. Credibility relates to the design of the study, analytical methods, methods of inference, as well as provenance of the work with regard to 

potential conflicts of interest, peer reviews conducted, and comparisons with other relevant studies. 

A valid and credible scientific process consists of a rigorous examination of ideas, review and critique by technically qualified 
6 

peers, open exchange of ideas among colleagues, and protection 

against manipulation of results by vested interests. 

I serve as a regular reviewer for scientific journals, as a member 

of editorial boards, and as an independent reviewer for national 

and international reports. In this capacity, I consider the framing 

of the study, the methods, the results, the researchers’ interpretation in light of my knowledge of the field, and relevant scientific 

literature. I may not agree with the conclusions drawn by the researchers, but if the aforementioned components are well-executed 

then the study contributes to the body of evidence, in my view. 

Every study is subtly different and should be judged by experts 

in the field on its merits, and in my view, best available science 

is research that is conducted in accordance with well-established 

scientific practices, including well-designed investigation, logical 

statistically rigorous analyses, clear documentation of data collection and analytical methods, careful peer review of results free 

from external influences seeking a particular policy outcome. 

I strongly believe that this process cannot be legislated without 

undermining innovation and unduly constraining the scientific information available to policymakers and to the public. If one were 

to legislate what should legally be considered best available 

science, it would prevent the innovation and flexibility that is inherent in the scientific process. This ability to innovate is essential 

for agencies as they address new discoveries, such as emerging 

public health threats. 

Public access to science that underlies regulatory decisions is important as part of our democracy and to ensure the rationale for 

decisions is clear, even if all do not agree with the final policy outcomes. On this point it is important to distinguish between data 

and science. The scientific information critical for an informed public concerns how studies are conducted, how information is interpreted, and inferences are drawn. This is not dissimilar from the 

information a peer reviewer like me considers in evaluating a 

study, albeit for the public in a non-technical form. Peer reviewers, 

in general, do not review raw data. 

Agency rulemaking must be informed by independent science advice that is free from political pressure. Twenty-four Federal agencies have developed scientific integrity policies that help ensure the 

independence of scientific advice. There is now legislation in both 

House and Senate that would codify scientific integrity policies into 

law, which I view as a positive step for protecting science-informed 

policymaking. Strengthening peer review policies in several agencies further safeguards government science. 

Best available science should be used to describe the weight of 

scientific evidence developed by a credible process for ensuring 

independence from political influence. Agency scientists supported 

by a commitment to independent science, scientific integrity policies, and appropriate transparency measures should be trusted to 

provide science advice to decisionmakers, and I agree it is advice. 

All Americans benefit when science is used to inform policy, and 

its integrity in the rulemaking process is imperative for a functional democracy and a safer, cleaner planet for all. 

Thank you Mr. Chairman, Ranking Member, and Members of the 

Committee. I appreciate the opportunity. 
7 

1The prepared statement of Ms. Beck appears in the Appendix on page 56. 

Senator LANKFORD. Dr. Beck. 

TESTIMONY OF NANCY BECK, PH.D.,1 SENIOR DIRECTOR, REGULATORY SCIENCE POLICY, AMERICAN CHEMISTRY COUNCIL. 

Ms. BECK. Good morning, Chairman Lankford, Ranking Member 

Heitkamp, Senator Hassan, and Senator Harris. I am honored to 

be here today representing the American Chemistry Council. My 

name is Nancy Beck and I have spent over 15 years working at the 

intersection of science and policy. 

The business of chemistry is a critical component for manufacturing safe, high-quality products. ACC member companies and the 

public rely on science to innovate, to advance product stewardship, 

and to prove the assessments of chemical risk. ACC members expect high-quality science and objective assessment processes to underpin regulatory decisions. 

Reliance on high-quality science is critical to ensuring public 

trust. Regrettably, that trust is eroding. In July 2016, almost 200 

toxicologists signed an appeal for the integrity in science. They 

were expressing concerns that precautionary regulations and policies are being presented as objective science, when, in fact, they are 

not. Dr. Rosenberg recently stated, ‘‘When science is sidelined from 

policy decisions, we all lose.’’ The American Chemistry Council 

shares these concerns. 

Improving agency science should not be as challenging as it has 

been. As you have mentioned, Senator Lankford, government and 

non-governmental guidance already exists. In 2002, Federal agencies were directed through OMB’s information quality guidelines to 

ensure the quality, objectivity, utility, and integrity of information 

which they disseminate to the public. 

Unfortunately, while most agencies have committed to meeting 

these standards, some agencies’ scientific analyses falls short. 

Some examples of this are provided in the testimony ACC has provided in writing. These shortfalls are despite Federal guidance on 

risk assessment and peer review, and further guidance from organizations like the National Academy of Sciences (NAS), the Keystone Center, and the Bipartisan Policy Center. 

The bipartisan Lautenberg Chemical Safety Act (LCSA) now 

mandates that EPA apply high-quality, reliable, and relevant scientific information by using best available science and a weight of 

the evidence approach. To date, EPA appears to imply that business as usual is consistent with these standards. Rather than explicitly incorporating the best available science and the weight of 

the evidence standards into the draft framework rules it is developing to implement the act, the agency has suggested that it can 

simply rely on existing approaches and current practices. This is of 

great concern to the ACC. 

The peer review report from EPA’s most recently released draft 

risk evaluation notes that EPA did not apply a weight of the evidence approach, nor did it use a systematic review process, which 

is a critical part of conducting a weight of the evidence evaluation. 

EPA simply chose the value that would provide the lowest allow-
8 

1The prepared statement of Senator Heitkamp appears in the Appendix on page 37. 

able exposure, without transparently documenting the quality of 

the individual studies they considered. 

The good news here is that there are many potential solutions 

to improve agency science, and I am going to present just four. 

One, improving and clarifying scientific definitions. The intent of 

the scientific standard is to improve existing agency practices. 

Agencies should provide clear and specific definitions for terms like 

best available science and weight of the evidence. These definitions 

should address not only what agencies should consider when evaluating information, but also what information agencies should 

present in the evaluations, forcing the agencies to show their work 

and present their thought process in a clear and transparent manner. 

Two, there must be stronger oversight to ensure that existing 

guidance is actually followed. Existing guidance documents could 

be converted into agency checklists and agency staff could self-certify that their evaluations are consistent with these checklists. 

These checklists could also be used by stakeholders and peer reviewers. 

Third, as was mentioned before, the importance of improving 

peer review practices cannot be underestimated. Ensuring that 

peer review panels have the depth and breadth necessary to address scientific concerns while also ensuring that conflicts and biases are addressed is critical. 

And fourth, the government can play an important role in changing the incentives for grant funding such that decisions are not so 

heavily dependent on finding positive results, and the government 

standards for funding should ensure that research studies follow 

best scientific practices and are designed with the regulatory use 

in mind. 

In conclusion, ensuring that Federal decisionmaking is firmly 

based on the use of high-quality science can be achieved through 

common-sense reforms that will lead to a more efficient and effective regulatory process. ACC looks forward to working with Members of the Committee to enhance approaches to ensure that highquality science is the foundation of regulatory decisionmaking. 

Thank you. 

Senator LANKFORD. Thank you. Before we move into our time of 

questions, as is our tradition on this committee, the Ranking Member and I will defer our questions at the end. 

Before we move to Senator Hassan, I want to recognize Senator 

Heitkamp for her opening statement. 

OPENING STATEMENT OF SENATOR HEITKAMP 

Senator HEITKAMP. Just a quick apology to our panel. I had a 

markup in the Banking Committee where a bill of mine was being 

considered, and I wanted to make sure it got across the finish line. 

So I had a chance to review your testimony and really appreciate 

your attendance, and I ask that the Chairman include my opening 

comments for the record.1

Senator LANKFORD. Absolutely. Without objection. So did you get 

your bill across the finish line? 
9 

Senator HEITKAMP. Well, I got it out of committee. 

Senator LANKFORD. OK. Out of the gate is a start. [Laughter.] 

So that is great. 

Senator Hassan, you are recognized. 

OPENING STATEMENT OF SENATOR HASSAN 

Senator HASSAN. Well, thank you, Mr. Chairman, and Ranking 

Member Heitkamp, and welcome to all of the witnesses today. 

Thank you all for being here. 

I wanted to start, Dr. Rosenberg, with a question to you. In your 

testimony you talk about the scientific community’s view of what 

constitutes best available science, and you also state that generally 

accepted standards cannot clearly be legislated without jeopardizing the kind of scientific innovation that leads to some of our 

most important findings and discoveries. 

So I would ask you to take just a minute or so to elaborate a little bit more on what you see as the problem with legislating what 

should be considered the best available science. 

Mr. ROSENBERG. Thank you, Senator. I think this is a really crucial point, of course, for the hearing, but in general as we think 

about the processes of bringing science into rulemaking. 

If you legislate best available science, I believe, from being an 

agency scientist and regulator, that is exactly what agencies will 

do and they will not deviate. And so even if there is clearly a better 

approach, even if there is new science that should be brought into 

the mix, agencies will say, ‘‘My mandate is to do it this way. I will 

do it that way until the mandate changes.’’ 

I know that there is some rhetoric that agencies do things differently from their mandates. From my experience, you spend an 

awful lot of time saying, ‘‘OK, what is the law telling us we need 

to do? ’’ and you really do not have very much time to do other 

things. If that guidance is given in statute for best available 

science, it will become very rigid in agency practice, and the danger 

there is that, science does actually evolve, quite dramatically sometimes. You want people to be able to include new information, new 

types of data collection that lead to new inference in their results 

and bring that to bear on the best policies for the Nation. 

Senator HASSAN. Thank you. Another question for you, Dr. 

Rosenberg. You highlighted the significance of understanding scientific uncertainties, but also the importance of acting once the 

weight of evidence is compelling enough to justify a reasonable policy solution. For example, while there may be a degree of uncertainty as to some aspects of climate change, there is widespread 

agreement that global climate change caused by human activities 

is occurring now and it is a growing threat to society, and as somebody whose home in New Hampshire just ran out of power because 

of sudden extreme winds this morning, like many Americans I am 

acutely aware of this growing sense of extreme weather. 

So why does science have uncertainty, why is it OK for scientific 

uncertainty to exist, and how does uncertainty play into the decisionmaking process. 

Mr. ROSENBERG. Well, again, thank you for the question. Uncertainty exists not only in science, of course, but unfortunately in life, 

but certainly scientific evidence will always have some degree of 
10 

uncertainty. I think the importance is to characterize that uncertainty but think of it in terms of, from a policy perspective, then, 

what risks are we incurring? 

And so uncertainty comes in many forms. As a scientist you 

think about uncertainty in really four different ways. You think 

about measurement error, which is your ability to actually measure 

what is happening in the world; process error, which is your understanding of the processes by which things move forward; implementation error, your ability if you implement something to actually do 

it accurately; and model error, your ability to characterize a process 

in a model which is inherently going to leave some aspects out. 

Well, that is helpful for scientists to think about those types of 

uncertainty and they mean something different, but to a broader 

public, and usually to policymakers, uncertainty means you do not 

really know. It does not necessarily mean that. I mean, all of those 

types of uncertainty are different. 

So if you go back to your climate change example, I would say 

it is not so much that there is a level of agreement among scientists as there is a very large weight of evidence, and if you look 

at that weight of evidence, it is quite compelling, any possible way 

you look at it. And sure, there may be people who say, ‘‘Well, I can 

identify one piece of evidence that does not seem to fit,’’ but the 

weight of evidence is entirely clear. 

Now you, as policymakers, are responsible for deciding how much 

risk we should take. That is not a science decision. I agree with 

Professor Dudley on that. We can say if you tell us something 

about risks that you believe society should incur, how the uncertainty that we have relates to those risks. Most people would say, 

if, in fact, climate is changing as rapidly as the evidence indicates, 

that the risks to many aspects of society are very high, so, therefore, you might want to take action with more uncertainty than, 

say, you would take in crossing the street. 

Senator HASSAN. Right. Well, thank you, and that leads me to a 

question for the whole panel, a general one, and I have a little over 

a minute left. So I want to follow up on that, because Dr. Rosenberg just described the balance between uncertainty and risk to 

public. In New Hampshire, as you all know, like in many other 

States, we have a heroin and opioid epidemic that is devastating 

and it is a critical public health threat. And the threat, the scale 

of it is stunning, it is unprecedented, and we have been really 

working hard to get in place the prevention, treatment, recovery, 

and public safety measures needed to support those on the front 

lines of this epidemic. 

But sometimes those interventions and methods we are using are 

newer, and while we have evidence supporting our policies, we do 

not always have the kind of 100 percent certainty that we would 

like to have to approach this public health epidemic. 

So the real question is, does scientific uncertainty about something mean we should not take action at all when the risk is high, 

and what dangers do you think legislating a definition of best 

available science could pose to responding to this type of urgent crisis? Because I have only got like 10 seconds left, Dr. Dudley, I will 

start with you and then I will ask the others to submit a written 

answer to that. 
11 

Ms. DUDLEY. Very briefly, no. Uncertainty does not mean act or 

do not act, but I agree with Dr. Rosenberg—it is a policy question. 

So scientists can tell you, ‘‘Here is the uncertainty. Here is why we 

have this uncertainty,’’ and it is policy officials’ responsibility to 

say, ‘‘Here is what action I would like to take,’’ knowing that uncertainty. 

Senator HASSAN. Thank you. 

Senator LANKFORD. Senator Harris. 

OPENING STATEMENT OF SENATOR HARRIS 

Senator HARRIS. Thank you. Thank you all for your work. I have 

to tell you my mother was a scientist, an endocrinologist, and, in 

fact, one of my first jobs ever was cleaning pipettes. I was awful. 

She fired me. [Laughter.] 

But I do appreciate your work and the importance of the work, 

and particularly the importance of politics not playing into your 

mission and the very important role you play in advancing us, in 

terms of human health and also what we need to do in terms of 

really thinking about what we can do in terms of being innovative 

as a country. 

So, Dr. Rosenberg, I have a question for you. This morning on 

CNBC, EPA Administrator Scott Pruitt stated that carbon dioxide 

is not a primary contributor to global warming. He said, and I 

quote, ‘‘I think that measuring with precision human activity on 

the climate is something very challenging to do, and there is tremendous disagreement about the degree of impact, so no, I would 

not agree that it is a primary contributor to global warming that 

we see.’’ And then he went on to say, ‘‘We need to continue the debate and continue to review and continue our analysis.’’ 

Separately, according to an article in the New Republic on March 

7, the EPA’s Office of Science and Technology, which has historically been in charge, of developing clean water standards for the 

States, had on its website that their standards were guided by 

science. Since January 30 of this year, the reference on their 

website to science-based standards has disappeared. 

So my question to you is that we are obviously talking a lot here, 

in this hearing, about sound science policy, yet one of the most important agencies that should consider science has removed the reference to science from their website. So can you talk a little bit 

about what you believe the role of science will play in the EPA and 

any other Federal agencies, and your concerns, if the importance 

and significance of science is diminished? 

Mr. ROSENBERG. Thank you, Senator, for the question. I was not 

good at cleaning pipettes either, so I became a fisheries scientist 

instead of a Senator, I guess. [Laughter.] 

The statements that you read are very concerning. I can only tell 

you what I believe the role of science should be. Clearly, the weight 

of evidence as—in my response to Senator Hassan—on not only the 

occurrence of global warming but also the human role in global 

warming, is very strong. In fact, it has been looked at by multiple 

studies, multiple investigators. All of the data sets indicate that 

you cannot really explain the data without attribution to greenhouse gas emissions, including CO2, but not restricted to CO2. 
12 

So it is very concerning to say that he does not believe that CO2 

is a primary contributor, and equally, that the uncertainty is so 

high that we cannot act, and I think this goes back to Senator Hassan’s question directly. Whether it be an opioid crisis, global warming, or many other issues, you really have to think about what is 

the risk. So it seems to me that the uncertainty is relatively low 

about whether global warming is occurring. There certainly is higher uncertainty about localized effects, but the risk of not taking action is quite high, and there are elements of understanding that 

risk that come from the science. 

For an agency like the EPA, which is fundamentally focused on 

public health and safety protections, which are largely identified by 

scientific work, to, in any way, diminish the role of science in the 

agency is extremely concerning because it is public health and safety, and that is what they were set up by Congress to do, and those 

are fundamentally science and technical questions. How you address them, of course, is both a policy decision for you and for the 

Administration, depending on which policies we are talking about, 

but I hope we would all agree that without a very strong science 

basis and recognition of that science, then we would be in serious 

trouble with regard to public health and safety across the country. 

I was asked what I make of the change in the website for the 

EPA Office of Science. I was very concerned about it because it referenced economically viable solutions as opposed to public health, 

and that certainly worries me. In my experience as a regulator, 

there is an awful lot of discussion about what is economically viable for whom, which part of an industry and which part of the public, and so on, but public health threats need to be front and center 

and predominant, and that is a science and technical exercise, by 

and large. 

Senator HARRIS. And so we have a lot of students in the hearing 

room, which always makes us happy. Can you explain to me and 

them, and the Committee, what you believe this might means in 

terms of the next couple of years, and what the diminishing of 

science has the potential to do, in terms of policy for the next couple of years, and any long-term impact as it relates to the health 

and well-being of our citizens? 

Mr. ROSENBERG. Well, first of all, again, I hope that the EPA 

continues to do what they have done for the Nation since it was 

created, and that is continue to protect public health and safety. 

And sure, I understand that people can criticize from different perspective, but fundamentally we should realize where we have come 

over the last 40 to 50 years, in terms of public health and safety. 

I live in the Boston area. Look at Boston Harbor or the Charles 

River or the air in Los Angeles, or whatever you would like, to decide whether that is important. So I hope the agency refocuses on 

using science and technical information. 

I believe that there are many actions that have been proposed or 

called out or mentioned by Administrator Pruitt and others in the 

Administration that would dramatically slow the ability to address 

public health and safety concerns, and I think that that is truly 

problematic, because while we have come a long way in 40 years, 

there certainly are many issues that continue to arise. So I hope 

students are thinking, first of all, it is really important to be in-
13 

1The article referenced by Senator Harris appears in the Appendix on page 74. 

volved in science and technology, and I have quoted you a number 

of times, Senator Hassan, from when we met, that, everyone here 

agrees that Science, Technology, Engineering and Math (STEM) 

education is really important. I hope we listen to the STEM-educated. 

And so I hope the students here think about STEM education, 

and also are thinking fundamentally about what history has shown 

us about public health and safety changes in the country. They 

may not remember L.A. when you could not drive down the streets, 

but it did occur, and we have learned a lot from the history of 

agencies like the EPA, and we cannot let up now. 

Senator HARRIS. Thank you. And, Mr. Chairman, I have asked 

unanimous consent that the article be entered into the record.1

Senator LANKFORD. Without objection. 

Senator HARRIS. Thank you. 

Senator LANKFORD. Before I recognize Ranking Member 

Heitkamp, I would encourage dialogue with us. We have a bill 

dealing with sound science, and it is not a partisan bill. That is everything, and for everyone, for either side of this. And so I would 

appreciate just the dialogue on that ongoing. 

So, Senator Heitkamp. 

Senator HEITKAMP. Thank you, Mr. Chairman, and thank you to 

all of the students here. I know this seems like it might be really 

boring, and not consistent with some fireworks that you see in 

other committee hearings, but I think that this discussion is so important to the future of our country. How do we take fact-based 

analysis, science-based analysis? And you will never separate facts 

from judgment. 

So we are going to have different judgments about different facts, 

and we are going to have to analyze those. But the problem is that 

frequently people have different sets of facts, and different visions 

of science, some of which you heard today. The challenge that we 

have right now regarding CO2—we can have this discussion, but 

frequently, on things like that, the world moves around us. Right? 

The Chief Executive Officers (CEOs) of major Fortune 500 companies move around us, and say, in their judgment, they have looked 

at it, they need to do things differently in their own contexts. The 

public moves around us. 

And that is always the challenge we have with science, because 

frequently, in Washington, D.C., it is politicized. We just have to 

put that out there, that science is in the eyes of the beholder, what 

is, in fact, scientific fact. And one of the things that I resist that 

we are doing a little bit today is we are just looking at one area, 

whether it is climate or whether it is, in fact, the EPA. 

This discussion goes beyond that, and I want to engage first with 

Ms. Dudley, because we have had long conversations about the application of fact-based analysis to rulemaking, and there is a challenge here because people look at rulemaking, or these challenges, 

through the lens of what they believe to be fact. 

I want to just give you an example. Recently—this is actually 

true—a basketball player suggested that the world was flat. That 

was in a tweet. I do not know if you saw it. And the response that 
14 

someone gave was, ‘‘Well, we should respect his opinion.’’ And I’m 

thinking, maybe not, because I thought Galileo dealt with this and 

was imprisoned. The Earth goes around the Sun. The Earth is not 

flat. 

But yet there seems to be an acceptance in this country for a 

wide variety of reasons which say let’s respect this. And so there 

is a widespread kind of narrowing of the lanes. You can have a difference of opinion within a narrow lane, but we cannot be swimming outside the lanes so that we accept or have a reasonable dialogue about the Earth being flat. I am just sorry. I am not going 

to do it. 

And so the reason why I raised that is, can we, in fact, legislate 

that lane in a way that really gets us back to using science, but 

also recognizes that judgment comes with science? And I would like 

to start with Susan. 

Ms. DUDLEY. I think that is a great way to look at it. There are 

some things that clearly we know, based on science. The world is 

not flat. There are other things where there is more uncertainty. 

As Dr. Rosenberg said, there is a lot of uncertainty. It is inherent 

in everything, not just science but in everything. And being able to 

differentiate what is pure science, what is pure policy, and what is 

in that trans-science area in the middle that we need to translate 

from pure science to policy, that is the trickiest thing. And if we 

can be more explicit about that, if scientists can say, ‘‘Here is 

where the science ends and here is the uncertainty around it,’’ if 

we could be more explicit about that, I think we would solve a lot 

of the problems that you are talking about, where we are arguing 

about science when we really are not. 

I will just quote briefly from The Bipartisan Policy Center. They 

had a report in 2009, on improving use of science in regulatory policy, and they concluded that ‘‘a tendency to frame regulatory issues 

as debates solely about science, regardless of the actual subject in 

dispute, is at the root of the stalemate and acrimony all too present 

in the regulatory system.’’ 

Senator HEITKAMP. Yes. Dr. Rosenberg. 

Mr. ROSENBERG. So I agree. I mean, this is an absolutely critical 

point. I believe, certainly, in the process of policymaking we should 

give different people their due, based on expertise. I certainly have 

an opinion on pretty much everything, my wife will tell you. 

Senator HEITKAMP. And you would agree with me, the world is 

not flat. [Laughter.] 

Mr. ROSENBERG. I am quite certain that the evidence is overwhelming. 

Senator LANKFORD. Have you ever been to western Oklahoma? 

[Laughter.] 

Mr. ROSENBERG. No, sir. 

Senator HEITKAMP. Or the Red River Valley in North Dakotas. 

Mr. ROSENBERG. So I recognize there is some uncertainty—— 

[Laughter.] 

But I actually think that the scientific evidence and the inference 

that you draw from that evidence, and call science, should be done 

by people who are working through a scientific process, and, in 

fact, are scientists. 
15 

By the same token, I certainly agree with Susan, that, everyone 

has an opinion and we need to try to be careful so that for me as 

a scientist to offer my opinion about, a policy matter and I am 

couching it clearly as this is my opinion about the policy matter, 

not that it is my science that dictates a particular policy matter. 

And so I often am in training for young scientists and students who 

will say it is important to distinguish—here is the evidence and 

here is what I think it means, in light of the body of scientific 

knowledge. Now if I want to say, ‘‘Here is what I think you ought 

to do about it, Senator,’’ that needs to be clearly separated. 

The difficulty in the current debate, of course, is that you have 

all kinds of people saying, ‘‘Well, the science says this.’’ ‘‘No, it says 

that.’’ Most of them seem to be non-scientists or observers, and I 

think they should offer their opinion, whether the world is flat or 

not, but I think we should weight it and not consider it scientific 

evidence. That is why I continually refer to the scientific process 

in my testimony. 

And I do not think that science is the sole deciding factor for 

most policies. It never is. You have an incredibly difficult job of 

making those societal choices. Those societal choices that you deal 

with every day are not a scientific decision. They are not part of 

the science process. All we can do is try to inform you of what the 

threats are, problems are, the opportunities, and certainly the consequences of certain decisions, based on the evidence that we have 

collected or have in hand. 

Senator HEITKAMP. Well, let us talk to Dr. Beck. 

Ms. BECK. Yes. It is a great question. To me, it comes down to 

transparency. I do not want you to trust me because I am a scientist. I want you to trust me because you have looked at my analysis, and you have been able to evaluate, if it rigorous, did it follow 

the scientific method, did anyone peer-review it? Right? If we can 

be transparent about the quality of the science and the uncertainties that come along with the science, then we can have a real dialogue about what the policy should be. 

So, to me, the solution is in clarity in transparency and the 

strength of the science. 

Senator HEITKAMP. Yes. I mean, I just think it is a big circle, 

and, there is consensus that this is the unknown in the middle. 

These are the variables in the middle. But there are scientific facts 

that do, in fact, establish and are widely accepted, in spite of what 

some person may say. Unfortunately, too often, we argue—let us 

take climate. For so many people, climate is not in the center. Climate is on the outside. This is known. And, in part, because I think 

it got politicized before there was ever an evaluation of the science. 

You see what I am saying? Because the public, and, I think, opinion-makers did not come to consensus on the science or on the variables before there was a lot of discussion about policy initiatives. 

And so it becomes a political issue as opposed to a scientific 

issue, and that is the challenge that we have, which is when does 

it cross the Rubicon? Can we achieve some kind of analysis? And 

Senator Lankford and I are struggling with this. How do we respect other opinions but also narrow the focus of what we consider 

scientific proof or sound science? 
16 

And so with that, that is more rhetorical than anything else. I 

will allow Senator Daines to have a moment here. 

Senator LANKFORD. Yes. I recognize Senator Daines. 

OPENING STATEMENT OF SENATOR DAINES 

Senator DAINES. It has been a great discussion. Thank you, Mr. 

Chairman and Ranking Member Heitkamp. 

I just would submit, for the record, that Exhibit A and B for the 

flat Earth thought would be probably in North Dakota and Oklahoma—— [Laughter.] 

And I will bring the contrarian opinion here, being from the 

Rockies of Montana. 

Well, thank you for testifying before the Committee today. I 

guess if you want to have a fun fact this morning, I am the only 

chemical engineer that serves in Congress, out of 535 of us here on 

the Hill. There are several engineers. I get to hold down the chemical engineering caucus of one. So I truly have a fundamental appreciation for the proper role of science in the Federal rulemaking 

process, because it should, above all, be objective, meaning two 

things above all. One, data should be able to stand up to public 

scrutiny, and, two, it can be replicable. 

When I worked at Procter and Gamble—I spent 28 years in the 

private sector before I came here to this new day job, where I wear 

a tie every day—our company used science to meet the needs of the 

mass consumer market, ultimately studying the needs of our consumers and rigorously developing a solution to meet that need. 

That is what made our business successful. It was the best type of 

sound and objective peer review you could ask for. 

As Ms. Dudley mentioned in her testimony, science can only tell 

us what is but not what ought to be, and for that the rulemaking 

process requires human judgment, which has run amok, in my 

opinion, as regulators continue to conflate science with their own 

personal judgments. 

I know the issue of climate came up. I will give you an example 

of that. I was in a hearing last year where we had Gina McCarthy, 

the Director of the EPA, come and testify. We were talking about 

the Clean Power Plan. And the Clean Power Plan, those regulations were going to affect the State of Montana more than any 

other State in the United States. It was going to have a devastating effect on our jobs—studies done by the University of Montana—our jobs, tax revenues, economic activity, double the increases in utility rates. 

So I asked Gina, I said, ‘‘Cato ran the regulations through an algorithm called Magic, where you take the regulation, it then determines what the projected reduction in CO2 would be, and then 

projects what the impact would be on global temperature, which ultimately these regulations were means to an end, in terms of trying 

to reduce CO2 and reduce the impact on temperature. 

And when Cato ran those numbers, the answer came back, 0.02 

degrees centigrade, which is negligible. It is a rounding error. And 

I challenged Gina on that. I said, ‘‘Gina, I understand what we 

want to do with these regulations and we can quantify the impact 

on people. We can also quantify the impact on the science on cli-
17 

mate.’’ And I was hoping she would refute my data, and tell me 

why I was wrong and why she had other studies. 

But in this limited peer review I had, from one senator to an 

EPA director, she did not refute the data. In fact, she said, ‘‘We 

need to do this because it is almost a moral obligation to show the 

world, and show China, and India, and other places, how we are 

leading in that effort,’’ to which I responded, pragmatically, ‘‘Well, 

if you we cede the leadership of technology for coal-fired plants to 

the Chinese and to India, we will not have a better outcome. We 

will have a worse outcome, environmentally speaking, because we 

do a better job in the United States of protecting our environment, 

and sure, we could develop clean coal technology, innovate it, and 

affect the entire world.’’ 

So I think this is an example, again, where we need to get into 

the science and not be afraid to debate the science, debate the facts 

and the figures here, to ensure that we have appropriate regulations and outcomes. 

Ms. Dudley, in your written testimony, you mentioned that Congress too often cedes power to regulators, allowing them to set policy objectives. An example you offered was the difference between 

the Clean Air Act and the Safe Drinking Water Act (SDWA), and 

how Congress required agencies to consider economic costs in the 

Safe Drinking Water Act. 

So my question is, would you say that agencies are currently 

compliant with statutory guardrails like requirements to consider 

economic costs and benefits? 

Ms. DUDLEY. Every President, going all of the way back to 

Carter, but more explicitly Reagan and Clinton, set in place standards that required agencies to look at the benefits and the costs of 

new regulations, and try to maximize the net benefits—get more 

benefits than cost, whenever possible. But it is subject to statutory 

constraints. The Safe Drinking Water Act is explicit and says you 

should look at the benefits and costs. The Clean Air Act, especially 

the ambient air quality standards, is not. In fact, it has been interpreted as saying that you cannot consider the costs of achieving the 

standard. 

This gets back to what I was saying to you, Senator, Heitkamp, 

regarding the blurring of the lines. In the Clean Air Act we pretend 

that we are making our decision purely based on public health, because we are not allowed to consider costs. But nobody really 

thinks that is true because we do not set the standards at zero. In 

the Safe Drinking Water Act, there is much less acrimony, much 

less argument over whether the science is biased or not, because 

we can be clear, here is what the science says; now let us do some 

tradeoffs in setting the policy. And I think, to the extent statutes 

can look more like the Safe Drinking Water Act, that allow us to 

be honest about where the science ends and where the policymaking begins, that would improve the analysis and also the decisions. 

Senator DAINES. Yes. If Congress were to have established these 

economic guardrails for agencies over past Congresses, do you have 

any estimate of how much cost it would have saved the economy, 

or how many jobs, perhaps, would have been created? 
18 

Ms. DUDLEY. There are just so few good estimates of the real impacts of regulation, either benefits or costs, but I could just give 

you an example. An EPA rule—not the Clean Power Plan but another rule that affected electric utilities, the Mercury and Air 

Toxics Rule—the Supreme Court sent that back to EPA because 

that statute set standards that are appropriate. 

Senator DAINES. Yes. 

Ms. DUDLEY. And the Court said, ‘‘It’s not appropriate to have $9 

billion in costs to achieve hundreds of thousands of dollars in risk 

reduction.’’ So, in that case, the Supreme Court said, when the 

statutory language says appropriate, it does mean this balancing of 

benefits and costs. 

Senator DAINES. Yes. 

Ms. DUDLEY. But yes, if Congress were more explicit, I think that 

$9 billion you would have been able to save. 

Senator DAINES. Yes. That is a pretty good number. Well, and I 

think you mentioned the Clean Power Plan. Certainly a little over 

a year ago the Supreme Court intervened, as well, on that. 

I want to talk about the redacting PII. I think that came up for 

public access. 

Oh, I am out of time, I see, Mr. Chairman. Are you OK? 

Senator LANKFORD. I will ask for unanimous consent to give you 

12 more seconds. [Laughter.] 

That is fine. 

Senator DAINES. I am having so much fun here, I am looking 

at—— 

Senator LANKFORD. It is all right. Go ahead. 

Senator DAINES [continuing]. The red light was on here, Senator. 

Regarding redacting PII for public access, Mr. Rosenberg spoke 

in his testimony that the public should not have access to scientific 

information used for regulations in order to maintain confidentiality. We do not use reams of paper anymore. We do use Excel 

and other forms. Dr. Beck, cannot sensitive information be redacted, since most data is electronic? 

Ms. BECK. Yes. I think sensitive information can be redacted, as 

well as protecting confidential business information, trade secret 

information. There are ways to share the data without sharing 

these important details. 

Senator DAINES. So it seems that researchers, can data mine, 

they can slice-and-dice numbers to perhaps draw their preferred 

conclusions. And back to that important point of peer review and 

scrutiny, do you believe there is wisdom in numbers on this one, 

and public scrutiny of scientific information could perhaps foster 

better regulatory rules and outcomes? 

Ms. BECK. Reproducibility, to me, is critical. Right? So often 

times you need the underlying data to actually reproduce the analysis. We have had situations at the American Chemistry Council 

where we did not understand an analysis that was presented by 

EPA, and at first we worked with the journal researchers, to try 

to get that data. We worked with the agency to try to get that data. 

Eventually—and this took years—we were able to get the data 

through a data transfer agreement with the National Institutes of 

Health (NIH), and they protected whatever information needed to 

be protected, and we were able to conduct a re-analysis of that 
19 

data. And that re-analysis came out differently than the agency’s 

analysis, so now we can actually have that important scientific dialogue to understand the data. So I think that access to information 

is really important. 

Senator DAINES. Thank you. 

Senator LANKFORD. Thank you. So this whole conversation is the 

challenge that we have back and forth between, we want to get 

good information, whether it is science, or whether it is facts, or 

research, or whatever it may be, in any area, because the policymakers need that, and the agencies need that. So the conversation 

today is really all about how do we get that balance between getting good science, but understanding we are not asking the scientists to be the policymakers, and in a strange way, we ask the 

Federal Bureau of Investigation (FBI) to go research, to go get everything together, and then they give all of their information to the 

Department of Justice (DOJ), and the Department of Justice determines whether to prosecute. The two are kept separate, so you do 

not have the people doing all of the research and all of the gathering of information also making the final decision. 

In a strange way, science and policymakers are the same way. 

We ask folks in science, ‘‘Do the research. Get the information.’’ 

But we have to make some final decisions on this on how to be able 

to balance it, but we want to make sure that is done in the same 

in the agencies. So the challenge is, how do we pull this together? 

Professor Dudley, you made a comment that I would like to be 

able to highlight more. You did not talk about it much, during your 

oral testimony, but you did in your written testimony—about risk 

assessments, and getting multiple options and opportunities, knowing that science does not always agree on some things. So giving 

kind of a larger window view of that. Can you go into a little more 

depth on that? 

Ms. DUDLEY. Yes. I think that would be very important, and because the model—— 

Senator LANKFORD. Describe what you mean by the risk assessments, and then take us through it. 

Not everyone in the room has read your written statement. 

Ms. DUDLEY. Well, you are missing something. [Laughter.] 

In developing, especially environmental and public health regulations, we go through a process where agencies assess the risk and 

then they try to manage the risk. And back in 1983, the National 

Academy of Sciences said, conceptually, we should think of those 

as two separate things-the risk assessment process and the risk 

management process, because the risk management process takes 

other factors into account—the economics, law, what other regulations are in effect, political goals—whereas the risk assessment is 

the scientific inputs. Again, risk assessment tells us what ‘‘is’’ 

versus what ‘‘should be.’’ 

But I think we have all talked about this. It is important to recognize that even in that risk assessment phase, it is not as 

straightforward as ‘‘the Earth is flat or not.’’ There is a lot of uncertainty. There are different models that predict different things, 

different data available, different assumptions used to apply those 

data to the situation that we are concerned about. And that is 

where a lot of these hidden policy judgments can get hidden. 
20 

So one of my recommendations—and this is not my recommendation but it comes from other people in this field—is that it would 

be better if the scientists were to lay out, using this set of assumptions, we get this number, a different set of assumptions provides 

different numbers. Lay that out, and then the policymaker can look 

at those different estimates, and that is the policymaker’s job. I 

mean, it is your job. It is the head of EPA’s job. Knowing this is 

a range of estimates, what is the right policy? 

Senator LANKFORD. You have worked with us before, at OIRA, 

and you are familiar with the process. What would that look like, 

as far as an executive action or a codification or—how would you 

consider something like that fitting into how we do our government? 

Ms. DUDLEY. That is a great question. It is so much harder to 

put it into a statute. 

Senator LANKFORD. Correct. 

Ms. DUDLEY. So in 2007, we issued—I forget what it was called— 

the Office of Science and Technology Policy and OIRA issued a 

joint paper that Ms. Beck was very involved in, on risk analysis in 

general. Not just the regulatory process. And that laid out some 

things that really had been based on a set of guidelines issued in 

the Clinton Administration. Those have withstood the test of time. 

I wonder whether that would be something that might be worth 

fleshing out a little bit more. 

Senator LANKFORD. OK. That is interesting to be able to note. 

Dr. Rosenberg, you have mentioned a couple of times that you 

feel like it will especially squash science and innovation if best 

available science is codified at some point. So I want to delve into 

that a little bit more, of the why, because as I read through it, my 

competitive nature says if it is the best available science and it is 

new science coming up, it would drive them to be able to show the 

validity of it, multiple locations to be able to see how it has been 

used, and to show this science, this technique, this modeling is better than that modeling, and to be able to push them toward that. 

You seem to imply that if we do best available science that will 

actually push all innovation out and only old science, that has been 

well-tested and has, as you have mentioned, weight of evidence 

from being used over and over again, will be the one that is used. 

How do we hit a balance on that, because this is not theory anymore? This is already being codified by Congress. It is in the Toxic 

Substances Control Act (TSCA) Bill already, of a standard for best 

available science. It has been in Executive Orders (EO) for a very 

long time. 

Mr. ROSENBERG. Thank you, Mr. Chairman. I think in TSCA and 

in other bills, there is some description of process, but if you codify, 

and, particularly, then becomes judicially reviewable, then people 

will retreat back to what is the most cautious interpretation in 

many cases. That is what I believe agencies will do. They will be 

careful about the information that they consider as part of that 

weight of evidence, and that means that you would be less willing 

to consider new information or information coming from other 

sources that might be critically important. 

I believe that you can certainly, through your oversight responsibilities, hold agencies to account that they have used a very effec-
21 

tive process. My concern is, in legislation, then it becomes a much 

more rigid vehicle. So it is not that I do not think that there is no 

such thing as best available science. I described what I think the 

hallmarks of best available science are in my testimony. 

I do not think it is as rigid, and if I can refer to Professor Dudley’s comments on risk assessment, as there is a good example. The 

view of how you do risk assessment in different fields has, in many 

cases, changed through time. You could legislate exactly how you 

should perform a risk assessment, including how do you 

paramaterize the models, if you like. Now you are getting down 

deeply into how do you actually conduct the science. 

On the other hand, there may be much better ways to approach 

that problem that emerge next year, the year after, or in a different field, and you want to make sure that people are able to do 

that and not say, ‘‘That is not how we do it.’’ 

In TSCA, it seems to me, and you are obviously an expert on 

TSCA, but there is an opportunity to use a structured system, but 

it does not apply across many other fields. Even the term 

‘‘replicable’’ or ‘‘reproducible’’—what does that mean to me as a scientist who does field studies on marine biology? 

Senator LANKFORD. You have to wait for that same fish to swim 

by again, in the same spot. [Laughter.] 

Mr. ROSENBERG. Yes. I would ask the fisherman to catch him 

again. 

Senator LANKFORD. Yes. We need to know—and I think the oversight portion of this feeds into what you just mentioned, that when 

people are looking at it, it is not just closest science, or the sciences 

in the cubicle next to you that was most convenient for the agency—— 

Mr. ROSENBERG. Absolutely. 

Senator LANKFORD [continuing]. Or it is someone that I graduated with, but there is an actual opening up to say, let us ask the 

broader question. Let us ask the entire science community. And 

going back to your comments earlier, about peer review—it seemed 

like you were very engaged in the issue of oversight on peer review 

process—to be able to ask the broader question, for us, as policymakers, to say, have we looked at a broader group of science? And 

just because you used them last year does not mean that this is 

the best available science this year. It could be someone besides 

your brother-in-law that has the best available science this year. 

Let us open this up. 

Mr. ROSENBERG. I entirely agree that the mechanisms for ensuring that the science is not only best available but—and is independent, are critically important, and those are peer review, disclosure of conflicts of interest, ensuring that you are bringing in information from other fields, all of those things, that are done in understanding that all of this science is scrutinized through a public 

process as well. 

Senator LANKFORD. That is the ultimate peer review. 

Mr. ROSENBERG. There are many aspects of peer review that 

occur in a regulatory process. 

Senator LANKFORD. But the question is, when you are going for 

best available science—and I am going to go to Senator Carper 

here in just a moment—but when you are going at best available 
22 

science, our goal of that, and what I hope we can do, and what I 

hope we did in TSCA—TSCA was so well-received it was voicevoted here in the Senate, as putting in statute, for the first time, 

something that has been in executive action for a long time, to say 

let us look at how do we open this up to as many people in the 

science community as we can, and ask the EPA, in this setting, to 

be able to look specifically at who you have used, but is that the 

best method to use, and go research that out, and go ask the real 

questions of it, and then to be able to put that in that language, 

and also, as you have talked about before, the weight of evidence, 

which we will come back and talk about in a moment again. That 

becomes extremely important. 

What we are trying to figure out is, if this works in TSCA, does 

it work in other instances, to ask for the data, to ask for the method, to ask for the model, to do the transparency, to do, as you have 

just mentioned, for the public to be able to look at it and do the 

ultimate peer review, and to be able to evaluate and ask the hard 

questions that need to be asked, and know it is going to stand up, 

that the scientists are willing to be able to say, ‘‘This is good 

science. We put our science out. Policymakers made their decisions 

based on that,’’ but at the end of the day, people can look and review the science. And so if you disagree with a policymaker, you 

can also go back and ask them, ‘‘Where did you get this thought 

to come from?’’ and you can also go back and disagree with them, 

and argue through the facts as well. 

Mr. ROSENBERG. All of those principles I agree with, but I would 

just add you also need to make it workable, because, of course, you 

cannot wait to make a decision about a toxic chemical, about a resource or anything else, until you have such broad engagement. 

And there always, of course, will be somebody with a contrarian 

view. 

Senator LANKFORD. Sure. 

Mr. ROSENBERG. And so it does have to be a workable system 

that agencies can actually manage. Otherwise, they will not actually carry out their mandated results. 

Senator LANKFORD. I could not disagree more, but even in emergency situations, where we have seen agencies step in and say, 

‘‘This is so vitally important. We need to engage right now for public safety and health,’’ there are mistakes even in that, and we 

need to allow for humanity to exist. 

One of the most obvious examples was recently, when agencies 

rushed in after the fertilizer plant explosion in West Texas, and it 

was immediately, we need to make these massive changes around 

the country, and then, 2 years later, the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) finished their investigation 

and discovered that was not an accidental explosion. That was an 

intentionally set fire. Well, that changed everything on the 

premise, that for 2 years the agencies had run with a false 

premise. 

So I understand everyone makes mistakes in the process on that, 

but good oversight helps us in the process as well, and a good set 

of boundaries for it. 

We will come back to this. I want to recognize Senator Carper. 
23 

OPENING STATEMENT OF SENATOR CARPER 

Senator CARPER. Thanks. Thanks so much, Mr. Chairman. Senator Heitkamp, good morning. Nice to see you. To our witnesses, 

Susan, welcome back. You have been here before. You should probably pay us by the appearance. [Laughter.] 

Dr. Rosenberg, Dr. Beck. I have a specific question for Dr. Beck. 

Before I do, I applaud our Chair and Ranking Member for holding 

this hearing. We are grateful to our witnesses for coming. 

I have a question for Dr. Beck, but before I do that I would just 

like to ask Susan if each of you just take maybe 30 or 45 seconds, 

since I did not get to hear your testimony, and just maybe give me 

what you thought would be a point that we should really walk 

away from here with. Give us a good nugget or two. 

Ms. DUDLEY. For me, I think it is that science is essential for informing regulatory policy, but it cannot decide regulatory policy, or 

policy, in general, and that there are other disciplines that are also 

important. And so often, when people accuse others of politicizing 

science, they really are talking about decisions that science can inform, but not decide. And if we could do a better job of being clear 

where the science ends and where the policy begins, I think it 

would open up to much more rational debate on the policy side, 

and we would not impugn science inappropriately. 

Senator CARPER. All right. Good. Thank you. Dr. Rosenberg. 

Mr. ROSENBERG. I would actually agree with that. I would also 

say that we should—when we are talking about concepts such as 

best available science, we should really focus on the process of developing that science. It is not a matter that everyone goes and 

redoes the analysis, that it is the science through a credible process, contributes to a weight of evidence. 

And then there is a judgment call on a policymaker’s side—is the 

weight of evidence enough to take action? But we should trust that 

there is a strong science process and continue to strengthen it with 

elements such as scientific integrity policies and transparency policies. 

Senator CARPER. Good. Thank you. Dr. Beck same question. 

Ms. BECK. So I agree with Susan Dudley about—both of them— 

about the separation of science and policy, and I think this is why 

it is important that we be really transparent about the quality of 

science. And the confusion about whether or not to codify a definition is—I just do not understand it. I think that people should commit to using an approach—that uses a clear criteria to evaluate 

studies, to ensure they are peer-reviewed. It does not put the finger 

on the scale for any particular study, but ensures that at that period in time, you are looking at all of the evidence and using the 

best evidence to define the science. And then you move it to the 

policy arena. 

Senator CARPER. Would it be safe to say that the three of you 

agree that we should not be blinded by science? 

I think everybody nods yes. Thank you. Thomas Dolby would appreciate you saying that. 

Dr. Beck, my colleague has been talking about Toxic Substance 

Control Act and his compadre from Oklahoma, Jim Inhofe, following David Vitter from Louisiana, Tom Udall, myself, and a 

bunch of others, worked for years to enact the full legislation. And 
24 

I think if they ever remake the filmstrip or civics video about how 

a bill becomes a law, I would nominate TSCA for the Oscar, and 

say—it took a long time, but, in the end, it was just really nicely 

done. 

The reason it was important that Congress act last year, was 

that TSCA had been essentially a broken law since 1991. I think 

some would say even before that, where an industry, I think in 

1991, successfully sued to overturn the Bush Administration’s proposed ban on asbestos. And they were able to do that because the 

old law required EPA, as you may recall, to choose the ‘‘less burdensome’’ regulation for industry, and industry argued that the 

EPA had not evaluated the costs and the benefits of all possible alternatives to a ban, even though EPA had spent, I guess, a decade 

or so writing the rule and had prepared thousands of pages of analysis. 

The EPA concluded that TSCA was unusable, and for decades it 

could not regulate the safety of chemicals it knew to be dangerous. 

Would you agree that the requirement that EPA select the ‘‘least 

burdensome’’ regulation is a major part of why old TSCA was unusable and a major part of why we all worked so hard together to 

reform it, Ms. Beck? 

Ms. BECK. Yes, that language was very problematic. 

Senator CARPER. If you want to say more that that language was 

very problematic, you can. 

Ms. BECK. Well, the language does not—— 

Senator CARPER. We do not charge you for testimony. We do not 

pay you either. [Laughter.] 

Ms. BECK. The language does not exist anymore, right? I think 

there was full agreement that the language confused the science 

and the policy. So now you have an unreasonable risk standard in 

the new Lautenberg Chemical Safety Act, which is based purely on 

the evaluation of the science. It looks at the hazards and the exposures under very specific exposure conditions, and then it makes a 

science determination. And then separate from that, there will be 

some risk management steps that consider costs and benefits, but 

there is no requirement on the agency to choose the least burdensome. 

Senator CARPER. OK. When we wrote the new law over the last 

couple of years, we told EPA to—try to first figure out whether or 

not a chemical was dangerous, and then to consider the cost when 

the agency was deciding how to protect people from whatever risk 

the agency had identified. We did not tell EPA, though, that it had 

to study the costs and benefits of every possible regulation, and we 

did not tell EPA that it had to choose the cheapest option. We told 

EPA it had to protect the public against unsafe chemicals and consider costs when it did so. 

Let us just say, for a moment, that EPA proposes a regulation 

under TSCA that costs industry, we will say, a billion dollars. A 

lot of money. And industry tells EPA, during the required comment 

period, that there is an alternative that will protect people just as 

well, that costs only a million dollars. A million versus a billion. 

Is it not true that the Administrative Procedures Act (APA) requires EPA to consider and respond to industry’s views on cost 

when they write the final rule? And that could be, again, you, Dr. 
25 

Beck. Is it not true that the Administrative Procedures Act requires EPA to consider and respond to industry’s views when EPA 

writes the final rule? 

Ms. BECK. So I am not an expert in the Administrative Procedures Act, but yes, the rulemaking process does require that the 

agency consider the public comments and provide responses to 

those comments. It does not require that the agency accept those 

comments but they have to consider them, discuss them, and explain how they were considered. 

Senator CARPER. OK. Thanks. 

Ms. BECK. Yes. 

Senator CARPER. Is it not also true that if EPA ignores that 

cheaper, equally protective measure in its final rule that industry 

could also sue and overturn the rule, under the Administrative Procedures Act? And if you do not know the answer to that question, 

maybe one of the other—your colleagues would. Dr. Rosenberg. 

Susan? 

Mr. ROSENBERG. Well, it is probably more Susan’s area than 

mine, but I would say that frequently happens with a claim that 

it is arbitrary and capricious, which is the language of the Administrative Procedures Act, and that was drummed into my head 

when I was a regulator, because that is in every challenge to a regulation—you have been arbitrary and capricious, which goes back 

to the role of science. So, yes, that is what APA does. It gives you 

that opportunity. 

Senator CARPER. Yes. Susan? Same question. 

Ms. DUDLEY. Yes, that is right. Anybody could sue if the agency 

did not base their final regulation on the material in the docket, 

which would be comments from the public, the data they have, et 

cetera. 

Senator CARPER. OK. Good. Who succeeded you at OIRA? Was it 

Cass Sunstein? 

[No audible response.] 

One of the things that President Obama asked him to do was 

to—I do not know if it had been done before, but I think they called 

it a look-back—to look back at regulations that had been adopted, 

in some cases many years ago, that may have served their purpose 

but did not anymore, and to see which ones should be saved, which 

ones modified, and which ones gotten rid of. 

I have read that that was a pretty successful endeavor. I believe 

it went on throughout the rest of the Obama Administration. Do 

you have any recollection of that? 

Ms. DUDLEY. You are right. It was actually something that every 

President since Carter has asked agencies to do. 

Senator CARPER. Yes. 

Ms. DUDLEY. And yet they really do not do a good job of it, for 

several reasons. One is that the incentives are not there. It is much 

more interesting to look at the next problem to solve rather than 

looking back, and even regulated parties often are not interested, 

because—especially if there are investments they had to make, the 

last thing they want is for the agency to say, ‘‘Oh, never mind. We 

should not have done that,’’ because then their competitors will 

have an advantage. 

Senator CARPER. Yes. 
26 

Ms. DUDLEY. But it is also hard to do. So it is not—— 

Senator CARPER. Did you do it while you were running OIRA? 

Ms. DUDLEY. Yes, and so I was at OIRA for the last end of the 

Bush Administration—— 

Senator CARPER. Yes. 

Ms. DUDLEY [continuing]. So I was actually wrapping up things 

that had been begun before me, toward the end. 

Senator CARPER. You were there on the clean-up? 

Ms. DUDLEY. I was there for the clean-up. I was finishing things. 

Senator CARPER. Oh, that is good. 

Ms. DUDLEY. But one of the things that I think about retrospective review is that it is not just to see what does not work and to 

rescind and reduce costs. It is to find out whether our estimates of 

the risk reduction benefits were accurate. It is part of the scientific 

method that requires hypothesis testing, gathering data and testing your hypothesis. 

So I think it is very important. There was a bill that Senators 

Lankford and Heitkamp introduced last year that would have required agencies, when writing a new regulation, to plan for how 

they would review it, 5 or 10 years down the road. That, I think, 

would be huge for the science, the risk assessment that goes into 

regulation—— 

Senator CARPER. Right. 

Ms. DUDLEY [continuing]. Ex-ante as well as ex-post. 

Senator CARPER. You are not just saying that because he is sitting here, are you? 

Ms. DUDLEY. No. Not because I am huge fan of both of yours, but 

no, that is not why. 

Senator CARPER. Thank you. And the converse is true. 

Thanks so much for being here and for your help. Thanks. 

Thanks, Mr. Chairman. 

Senator LANKFORD. No, thank you, and can I finish up this conversation as well, when we were talking about finishing and closing 

and cleaning it up, and we will have about another 10 minutes or 

so if you all are kind of wondering on time, unless we keep going, 

and then it goes until one. We will see. 

My question for you is this issue of retrospective review. How 

does that work in the science, and I am still thinking about the legislative side of this. Let us say you have a regulation that is a $100 

million-plus regulation that comes out. Seven years later you go 

back and look at it. It is not accomplishing what you want. The 

science has moved, as Dr. Rosenberg, you have talked about often. 

The science continues to develop in research. You have better 

measurement tools and you figure out your hypothesis did not 

work. How do you do a retrospective review when there is also a 

scientific opinion that is sitting, that may, at that point, be 10 or 

12 years old? Are you talking about a retrospective review that 

would also include re-evaluating the science again, or just looking 

at the numbers, or trying to evaluate that? 

Ms. DUDLEY. I actually think thats one of the under-appreciated 

advantages of doing better retrospective review would be evaluating whether our scientific predictions were right. So it is not just 

valuable for the regulations that we issued 10 years ago, because 

it may be too late to change those, but it helps us the next time 
27 

we issue a regulation, we will know which of our assumptions 

maybe were not right. So I think it will improve the science if we 

could do a better job of it. 

Senator LANKFORD. Right. And it is the same thing whether it 

is economics or whether it is science of any type, that you get a 

chance to note, this is what we estimated, this is what we thought 

would happen, this is the model, and then we look at it 5 years 

later and say, is the model proving to be correct, and sometimes 

you have not had enough time to be able to evaluate it, and sometimes you have. 

Ms. DUDLEY. It is just an essential part of the scientific method. 

Senator LANKFORD. OK. I want to get into this issue of weight 

of evidence. Dr. Beck, you and Dr. Rosenberg both brought this up 

significantly, both in written comments and in oral comments as 

well, by dealing with the weight of evidence. Dr. Beck, you mentioned several spots that you had some frustration already with the 

EPA not looking at weight of evidence. I would like to get a chance 

to talk about that and figure out how we address that, because that 

is one of the things in TSCA, specifically in statutory language, 

that this Congress said, ‘‘no, we want EPA to look at weight of evidence in this role, and to be able to figure out where that comes 

from.’’ 

So, Dr. Beck, if you want to talk about how you see that being 

applied right now and then let us try to figure out how we actually 

deal with this. 

Ms. BECK. Yes. So in the Congressional Record associated with 

the TSCA rulemaking, there is a definition for weight of evidence, 

and we would like to see the agency simply adopt that definition. 

It basically would commit them to looking at the studies and evaluating their strengths and limitations using a systematic review 

process which is a standardized process for essentially evaluating 

evidence, providing sort of the recipe for how you are going to bake 

your cake before you bake it. Everybody knows the criteria that 

you are going to use, the plans that you are going to use for analysis. You put that up front. You are clear about how you are going 

to collect your literature and evaluate your literature and do the 

analysis. So once you have evaluated the strength of the evidence, 

right, the individual strength of each individual studies, based on 

the quality of those studies, you weight it all and you make your 

determination. 

So that is the definition to us that seems so straightforward and 

so consistent with the scientific process, we think it should be 

adopted into the regulations that EPA is writing, to implement 

TSCA. 

Senator LANKFORD. OK. Are there other definitions out there for 

weight of evidence that you would recommend, other than what 

was done in the Congressional Record? 

Ms. BECK. The term has been confused over the years. Some people use a strength of evidence approach. That is very different and 

we do not support a strength of evidence. That is how many studies 

are positive, how many are negative—— 

Senator LANKFORD. Right. 

Ms. BECK [continuing]. And oftentimes people discount the negative studies. We only think the negative studies should be dis-
28 

counted if they are of bad quality. If they are of high quality they 

should be considered equally. 

So, to me, the cleanest approach is to adopt the one that the Congressional drafters had, and there was support for that definition 

in the House language as well as in the Senate language. 

Senator LANKFORD. OK. Dr. Rosenberg, any comments about just 

the weight of evidence? 

Mr. ROSENBERG. Well, I would just say that the weight of evidence is more than just tallying up the number of studies, and I 

do not think that you can equally weight every study. And so I do 

not disagree that there should be clear guidance from the agency, 

in terms of—so that people can understand how the agency will interpret information going forward. But I would caution against saying, well, if it is a credible study then everything gets equal weight, 

because that is not how you would do it as a scientist, certainly. 

You would consider the uncertainty. You would consider a lot of 

factors around the study and weight things appropriately. 

Senator LANKFORD. Back to the range of options, Dr. Beck, you 

had mentioned one of your proposals, grant funding not based on 

positive outcome. 

Ms. BECK. Yes. So, in the scientific world there is this concept 

of publish or perish, and that if you do not have a strong publication record you are not going to get promotions in academia and 

you are not going to get tenured positions. And in the journal 

world, there is an incentive to only publish data that are positive. 

People do not like to publish negative studies. People have talked 

about creating journals of negative data so that people are not reproducing the same studies that fail over and over again because 

the public does not know that they fail, because nobody is publishing them. 

So if there was a way to, at least within the Federal Government, to encourage the publication and the presentation of negative 

data, that would be extremely helpful. 

We are aware of cases, for instance, at the National Institute of 

Environmental Health Sciences (NIEHS), where they have done 

some studies that are actually negative, and we have been talking 

to them, can you please publish these data? These are important 

studies. And at this point in time there are not incentives to them 

to release negative data as much as there is to release positive 

data. 

Senator LANKFORD. But when you talk about grant funding 

based on it, the grant funding should be, at the beginning of it they 

do the study, not at the end of it. Somewhat this sounds like—— 

Ms. BECK [continuing]. Yes—— 

Senator LANKFORD [continuing]. You want to make sure your 

study ends up positive at the end if you have got grant dollars, if 

you want to get more grant dollars. 

Ms. BECK. If you want to get more grant dollars. That is correct. 

You have a 5-year grant and you want to get your grant renewed, 

or you want your center renewed, you want your center to have 

positive findings or it is not likely to get renewed by a Federal 

agency. 

Senator LANKFORD. So is it the fear that the science either gets 

limited—there were, for lack of better terms, 10 things we learned 
29 

not to do, one thing we learned to do, and we only published the 

one because you want to show positive, or is your fear that the 

science is going to make sure that they try to push it and steer it 

toward something positive, regardless? 

Ms. BECK. Well, it is actually both. The official term is publication bias, and that is that what exists in the literature are mostly 

positive findings. So then when people go to evaluate all of the evidence in totality, they are going to have a lot more positive studies 

than negative studies, and then what you cannot evaluate does not 

get to inform your regulation, right, so the positive studies are then 

informing the regulation and the negative studies, which are not 

published, are not known. 

Senator LANKFORD. OK. Dr. Rosenberg. 

Mr. ROSENBERG. Just very briefly, while I agree that occurs, it 

is not restricted to grant-funded research. Of course, industry does 

the same thing. Clinical trials are the classic example of that. You 

do not put forward the clinical trials that did not show the positive 

effect. And so there is a problem of those incentives. It is all across 

industry and it is also in academia. 

Senator LANKFORD. OK. Both of you also mentioned the issue 

about peer review, and if there is a legislative—in fact, Dr. Rosenberg, I think you said if there is an area to address in legislation 

that peer review process or trying to improve that was one of the 

areas. But regardless of whether it is legislative or not, what would 

be your recommendations on trying to deal with the peer review 

process, or how we label this, this is a peer-reviewed study, and 

still determine the quality of that? 

Mr. ROSENBERG. Well, I think I said that both scientific integrity 

and peer review were important areas for progress. I think the 

independence of peer review is critical, where you are actually getting the peer reviewers, and the breadth of that peer review. This 

is actually not the same as a peer review you do for academic journals, where, there is a limited number of reviewers and then you 

can move forward with publication. Obviously, in regulatory work, 

you have to have a more intensive process, and that goes to the selection of peer reviewers and so forth. 

I think, from a legislative perspective, it is important that agencies be clear about what their peer review process is, and how they 

select reviewers. We should be careful that reviewers are not representatives of different interests, so the idea that has been in 

some quarters in science advisory boards, that you should have 

representational members. That is a bad idea for peer review. You 

should be there because of your expertise in particular areas and 

you contribute to the review. There are questions in regulatory review about whether it should be anonymous review or not. The 

most important thing is that there is a clear and transparent, process for how we are going to conduct peer review. People can know 

that we did it—— 

Senator LANKFORD. So let me press on that a little bit. When you 

are talking about representational review, do you have an issue, for 

instance, if you were doing—let us say we are testing safe drinking 

water, that EPA is both doing their own sample with their own 

agency folks. Industry that may be nearby that they know that 

they are suspect, should they be able to be at that site, be able to 
30 

pull from that same—if you are going to pull 10 gallons of water 

out and be able to examine it, they pull a quart out of it as well, 

out of that same group, so they are able to run it through their lab? 

So you have multiple competing labs all checking it, because as you 

know well, there are some differences in all of the testing there. Do 

you have a problem with that type of peer review, where it is a 

group that could be affected by it, but they would have to be there 

onsite to be able to make sure their sample is consistent? 

Mr. ROSENBERG. So I do not have any problem with having, as 

you describe, different entities involved in the sampling. What I 

would say is that if you are going to then apply peer review, which 

is independent, outside experts who look at the results, and look 

at the methodology, and do all of the things that you do in peer 

review—this is not, again, the raw data, but how it was done—that 

that be done not just for the agency analysis but it also be done 

then if the affected industry says, oh, well, we got different results—— 

Senator LANKFORD. Show your data. 

Mr. ROSENBERG [continuing]. It should have exactly the same 

peer review standards. 

Senator LANKFORD. Yes. 

Mr. ROSENBERG. The difficulty I have had in regulatory settings 

is that I might go through, 20 public meetings on scientific analysis 

for, again, marine resources. I know you have many of those in 

Oklahoma. And someone else would stand up and say, ‘‘Well, my 

results are different.’’ You have absolutely no idea whether that 

has been reviewed or who has reviewed it. It is not meeting the 

same standard at all. So you have to compare like with like. 

Senator LANKFORD. Yes. You will be glad to know that Oklahoma 

has more fresh water shoreline than any other State in the union. 

Mr. ROSENBERG. I am really happy to know that. 

Senator LANKFORD. We dig a lot of ponds. [Laughter.] 

So we do that. We know how to store our water. 

Let me ask for your quick response on that as well, and then I 

want to try to move on to a final question. 

Ms. BECK. Yes. Peer review is an area that I think could benefit 

from a lot of improvements. One of these issues relating to representative, equal review of all data is funding. I listened to a peer 

review panel where there was a very good study funded by industry, and when it came up one of the peer reviewers said, ‘‘Wait. 

Was not that funded by industry? We are not going to consider 

that.’’ It was just completely discounted, simply based on its funding, and there was no evaluation of the quality of the data. 

So, again, I think these peer-review panels, of course you need 

to address conflicts and biases, but you need the breadth and the 

depth and the expertise. If you are reviewing something about a 

manufacturing process and you have nobody that understands the 

manufacturing process, I do not think that peer review is going to 

end up being very good. 

In the FDA, they have ways of having experts that might have 

conflicts on panels to help educate the panels, but they do not vote. 

Senator Carper referred to the Oscar-winning TSCA rule. The 

TSCA legislation actually requires different representations on the 

review panel, and those representations include animal welfare, 
31 

labor, industry. In putting that panel together for the industry representation, EPA has chosen two people from the pharmaceutical 

industry. These people do not understand the chemical manufacturing process and TSCA does not regulate pharmaceuticals. 

So I think you have to reach a point where you ensure that you 

have the right expertise and breadth to do a high-quality peer review. 

Senator LANKFORD. Yes, which makes it a challenge after the 

fact. 

Ms. BECK. Yes. 

Senator LANKFORD. The TSCA language on the science section, 

do any of the three of you have an issue with that, how it was written for that area, as much as you know the language? I am not 

going to ask you to know every word of it, but as much as you 

know. Dr. Beck. 

Ms. BECK. So I would just say that that language, it is consistent 

with what is in the information quality guidelines. It is very consistent with what is in the Safe Drinking Water Act. It should not 

be new to the agencies. 

Senator LANKFORD. No, it has been in existence for a long 

time—— 

Ms. BECK. Yes. 

Senator LANKFORD [continuing]. As Executive Orders and other 

actions. 

Ms. BECK. It is not new. It is around, so it is actually nice to see 

it in there, and we hope that when EPA finalizes their framework 

rules under TSCA they will commit, to meeting those standards in 

their rules. 

Mr. ROSENBERG. Chairman, I do not know the language in that 

little detail. I would just refer back to one comment that Dr. Beck 

made, about representation on a peer-review panel. That is exactly 

the problem of having people who are there to represent a particular interest. They are no longer peer reviewers. If they are 

there because they have particular expertise, I do not have a problem. 

Senator LANKFORD. Right. 

Mr. ROSENBERG. But if you say, ‘‘I am here as an industry reviewer. I am here to represent the interests of industry,’’ or nongovernmental organizations (NGO’s), then I have a real problem. 

That is not a peer review to me. 

Senator LANKFORD. Right. 

Ms. BECK. I agree with you. It should be expertise. 

Senator LANKFORD. Right. So let me ask this question. Is there 

an issue with trying to get the data, the models, and the methods 

out, so when an agency concludes their work, you can ask the practical question, ‘‘You came to this conclusion as an agency head. You 

based it on this report. Can we see—with private information excluded, obviously, and redacted—the data, the models, and the 

methods’’ to be able to come to that? Susan Dudley. 

Ms. DUDLEY. I think that is essential, and I will just read from 

Science magazine which requires that now for their articles. The 

editors, when they made the change to make data available, said 

that ‘‘when the greatest number of creative and insightful minds 

can find access and understand the essential features that led to 
32 

the collection of a data set, the data reached their highest potential.’’ 

So I think that is an essential element of the transparency that 

you mentioned in your opening statement. 

Senator LANKFORD. OK. Dr. Rosenberg. 

Mr. ROSENBERG. I do not agree that the raw data is needed and 

I do not think that is what Science requires, in most cases. At least 

whenever I publish there they do not ask for the raw data. I think 

the confidentiality is not just for public health records. It is also 

confidential business information, intellectual property. It gets very 

complicated quickly. 

Again, for most studies, you are not reviewing the raw data but 

you are doing exactly what Susan said. You are looking at how was 

the data collected, what is the provenance of the study, models, and 

so on. Does that mean that we would never consider results from 

a proprietary model, including the magic model that one of your 

committee members cited? For evaluating the Clean Power Plan we 

should not consider that because that model is proprietary. So 

there is a whole range of information, not just public health information. 

I think that to the extent that data can be released, fine, but I 

do not think that that should be the requirement, and if you cannot 

do it, for multiple reasons, therefore, you do not move forward. 

Senator LANKFORD. How do we have transparency without knowing the data, or without knowing the process of how it was put together? Because as you know well, the variables within data and 

the assumptions that underlie that can vary dramatically. 

Mr. ROSENBERG. I have absolutely no difficulty with describing, 

in detail, how the data was collected. The data collection process 

is part of something I review in every study that I look at. The 

modeling process is something that I review in every study that I 

look at, because I tend to mostly review modeling studies. I do not 

review the raw data. 

Now, sure, some people may want to do alternative analyses of 

that raw data. It is almost inevitably going to be for regulatory 

matters, industry. Nobody else would have the capability of doing 

that. But again, then, interpreting those results, unless they are 

put back into exactly the same peer review process that the agency 

used, is almost impossible, and the difficulty then is you have gotten into a very difficult, very long process of review with almost no 

end, because anyone putting in a new process starts a new round 

of peer review and you just stay in peer review forever. 

So I think you need to be realistic about what the information 

will be. The information to review is the details of that process of 

how that data was collected, certainly, and all of the other elements of the study, as I indicated in my testimony. 

Senator LANKFORD. OK. Dr. Beck. 

Ms. BECK. I noted this is in my testimony. The public trust is 

eroding in science. There are articles in the Washington Post about 

how 50 percent of the science that is published is, maybe false and 

not true. And I am not saying every study is unreliable, but if you 

want to have trust and confidence in your regulatory decisions, you 

need to be as transparent as you can absolutely be about that un-
33 

derlying data, so that everyone is on the same page and can have 

a scientific dialogue. It helps to build trust and confidence. 

So proprietary information, private information, all that needs to 

be protected. There are ways to protect proprietary information in 

models while letting other people look at those models. I think 

there are legal ways data-sharing can happen, and to the extent 

that the scientific community can improve that, the public confidence in the science will be greatly improved and confidence in 

regulatory decisions will be improved. 

Senator LANKFORD. Yes, that is a balance, obviously. We want 

people to be able to do their research, to be able to protect their 

data. They have paid for it, they have worked through the process, 

unless it is the Federal taxpayer that paid for it, and that is a 

whole different set of issues. 

But the challenge that we face is trying to trust it and to say 

‘‘how can we get a chance to do a good evaluation,’’ even things 

that are given the tag ‘‘it was in a journal,’’ ‘‘it was published,’’ or 

‘‘it was peer-reviewed.’’ 

One of my favorites studies, when we were going through and 

doing the preparation for all this, and the research, was finding Dr. 

Bohanan’s tests from Harvard, the biologist there, where he wanted to find out how the scientific journals went, and so he created 

a completely bogus study, with bogus modeling and everything else, 

and presented it to 300 different scientific journals, and 157 of 

them accepted it. And you think, OK, there is a challenge here, 

even within scientific journals, on how they accept what is fact and 

what is, at that point, completely bogus information. So we have 

to be able to guard that, and that is part of gaining public trust. 

The one thing I would like to do is be able to maintain this conversation. We are seeking a way to be able to solve this legislatively. We do not want to overreact and what it has done and able 

to squash the future of science, or to be able to compel people to 

not do research or to be able to put proprietary information that 

should not be put in the public domain not in there. 

I would tell you I serve on the Intelligence Committee as well. 

We deal with a tremendous amount of redacted information and a 

tremendous amount of research that can be put aside with private 

information. So I think there are ways to be able to accomplish 

some of this without putting people’s private information or proprietary information at risk, so we can still gain trust. 

So I would appreciate your feedback as we walk through this 

process. The legislative process, as I can assure you, is a messy 

process, and I would appreciate it if you would join us in the mess, 

and any ideas that you have. 

Before we adjourn I do want to announce that on April 6, the 

Subcommittee intends to hold a hearing regarding our continuing 

efforts to address potential problems and solutions associated with 

the Federal workforce. 

This concludes today’s hearing. I do, again, want to thank your 

witnesses for being here today. I appreciate knowing your work. 

We did not get to even 10 percent of what you each submitted in 

your written work as well, and I do bemoan that, but we are out 

of time. 
34 

The hearing record will remain open for 15 days until the close 

of business on March 24, for the submission of statements and 

questions for the record. 

I thank all of you again. This hearing is adjourned. 

[Whereupon, at 11:59 a.m., the Subcommittee was adjourned.] 
(35) 

A P P E N D I X 
36 

Yet, despite these clear directives, agencies continue to use questionable science to support their 

regulatory decisions. 

For example, in 2015 when the EPA proposed a ban on chlorpyrifos (chlor-pier-i-fos), an 

insecticide that farmers have been using successfully for decades, the agency based the 

regulation on a study that was discredited by their own Scientific Advisory Panel and the USDA. 

I understand agencies often face difficult choices and not all studies come to the same 

conclusion, but it is very concerning when agencies are not open about why they choose to use a 

study with such significant criticism. 

When agencies hide information from both Congress and the American people it is our job to 

question their motives and methods. 

Transparency is not an unreasonable request. In fact it will go a long way in forcing better 

regulations and heading offlawsuits. 

When agencies issue regulations that place legally binding requirements on the American people, 

the data the agency uses should be publically available for independent third-party review. 

When many of the most costly Clean Air Act regulations are based on a single Harvard study, 

the EPA should not be able to hide behind the excuse that they can't release the study because 

they don't own it, Harvard does, despite the fact that Harvard receives well over a half of a 

billion dollars in federal awards. 

Examples like these call into question whether agencies are actually using the best information 

available to them when they make regulatory decisions. 

Each administration has their own priorities, but the principles supporting regulatory decisions 

should remain constant regardless of who occupies the White House. 

If past administrations' attempts to encourage agencies to base their regulatory decisions on 

transparent sound science have failed, Congress should consider establishing new legal 

requirements. 

I look forward to discussing steps Congress can take to implement these basic and fundamental 

requirements that have been endorsed by both Democrat and Republican administrations for 

decades. 

With that, I recognize Ranking Member Heitkamp for her opening remarks. 
37 

U.S. Senate Committee on Homeland Security and Governmental Affairs 

Subcommittee on Regulatory Affairs and Federal Management 

Opening Statement of Ranking Member Heidi Heitkamp 

(As prepared for delivery) 

Hearing on Agency Use of Science in the Rulemaking Process: 

Proposals for Improving Transparency and Accountability 

Thursday, March 9, 2017 

Thank you Mr. Chairman. Today's hearing focuses on a vitally important subject. 

Science is an indispensable tool for policy makers. It's fair and proper use allows us to make 

informed decisions based upon the weight of evidence. Science is also a key driver of 

technological and economic innovation. Science can create new industries and new jobs. 

Science can change the way we live our lives. Science also needs to be part of our nation's 

regulatory process. 

Science, in its many varied forms, can play an important role in giving Congress, the 

Administration and the federal agencies important information that can help inform policy 

decisions. For this reason, it is critically important that our nation seeks to uphold the highest 

standards of scientific integrity. In the rulemaking space, a big part of that is improving 

transparency and accountability. It's not enough for agencies to say "trust us." They must be 

able to demonstrate that a decision affecting tens or hundreds of millions of Americans is fully 

reasoned. 

Today, I hope to hear some strong ideas on how to increase transparency and accountability in a 

manner that is consistent with the public interest. The public should have access to data and 

information but we also need to include common-sense protections. No one wants personal 

information shared in a regulatory docket, and agencies may need access to legitimately 

proprietary information from businesses to make the best regulatory decision possible. 

What is clear is that there is a balance to be struck. Accessibility and transparency need to be at 

the forefront of any discussion about regulatory reform and improving the regulatory process. 

However, we also have to understand that the term "science" encompasses a vast array or 

information and methodology in a wide variety of disciplines. It may not be possible to settle on 

and determine a single methodology to achieve scientific results that works across the entire 

federal enterprise. 

I want to submit for the record a statement from Harold P. Wimmer, National President and 

CEO, of the American Lung Association, outlining principles to guide the use of science in 

federal policy development. I look forward to hearing the testimony of our witnesses and any 

suggestions they have to promote reasonable and balanced steps that advance our mutual 

objectives. 
38 

THE GEORGE WASHINGTON UNIVERSITY 

WASHINGTON, DC 

Prepared Statement of Susan E. Dudley 

Director, GW Regulatory Studies Center 

Distinguished Professor of Practice, 

Trachtenberg School of Public Policy and Public Administration 

Hearing on 

Agency Use of Science in the Rulemaking Process: 

Proposals for Improving Transparency and 

Accountability 

Homeland Security and Governmental Affairs 

Subcommittee on Regulatory Affairs 

United States Senate 

March 9, 2017 

The George Washington University Regulatory Studies Center 

805 21" St, NW, MPA 612 

Washington, DC 20052 

202-994-7543 

RegulatoryStudies@gwu.edu 

www.RegulatoryStudies.gwu.edu 
39 

Agency Use of Science in the Rulemaking Process: 

Proposals for Improving Transparency and Accountability 

Prepared Statement of Susan E. Dudley March 9, 2017 

Thank you Chairman Lankford, Ranking Member Heitkamp, and Members of the Subcommittee 

for inviting me to share my thoughts as you consider improving the transparency and 

accountability of science in the rulemaking process. I am Director of the George Washington 

University Regulatory Studies Center, and Distinguished Professor of Practice in the 

Trachtenberg School of Public Policy and Public Administration.' From April 2007 to January 

2009, I oversaw federal executive branch regulations as Administrator of the Office of 

Information and Regulatory Affairs (OIRA) in the Office of Management and Budget (OMB). I 

have studied regulations and their effects for more than three decades, from perspectives in 

government (as both a career civil servant and political appointee), the academy, and consulting. 

1. The Importance of Transparency and Accountability in Regulatory 

Science 

Effective regulatory policy that focuses resources on addressing real threats to public health and 

the environment depends on reliable scientific information and transparent policy choices. 

Unfortunately, such regulations are often the subject of heated debate, involving accusations of 

"politicized science." 

Problems arise when political decision-makers attempt to distort what scientific studies conclude, 

but also when scientists and others attempt to exert influence on policy decisions by selectively 

presenting, or even distorting, scientific findings While there is extensive media coverage of the 

former, the examination of how science may be politicized inside federal regulatory decisionmaking processes has been largely limited to academia and the scientific community. 

As the Subcommittee considers proposals for improving transparency and accountability in 

agencies' use of science in the rulemaking process, it should recognize two types of politicized 

science that can infect policymaking within regulatory agencies. The first is when scientists, 

intentionally or unintentionally, insert, but do not disclose, their own policy preferences in the 

scientific advice they provide government decision-makers. Such "hidden policy judgments" 

1 The George Washington University Regulatory Studies Center raises awareness of regulations' effects with the 

goal of improving regulatory policy through research, education, and outreach. This statement reflects my views, 

and does not represent an official position of the GW Regulatory Studies Center or the George Washington 

University. 

Prepared Statement of Susan E. Dudley, HSGAC Regulatory Affairs, March 9, 2017 

www .RegulatoryStudies. gwu.edu 2 
40 

lead to what has been called "advocacy science"2 or "normative science."3 The second is when 

scientists and/or policymakers conflate scientific information and nonscientific judgments to 

make a policy choice, but then present that decision as being solely based on science. 

It is this tendency to "camouflag[e] controversial policy decisions as science" that Wendy 

Wagner called a "science charade"4 and it can be particularly pernicious. For instance, a 2009 

Bipartisan Policy Center (BPC) 2009 report, Improving the Use of Science in Regulatory Policy, 

concluded that "a tendency to frame regulatory issues as debates solely about science, regardless 

of the actual subject in dispute, is at the root of the stalemate and acrimony all too present in the 

regulatory system today."5 Both of these problems, hidden policy judgments and the science 

charade, can be the result of officials falling prey to the "is-ought fallacy": incorrectly mixing up 

positive information about what "is" with normative advice about what "ought to be." 

Institutional arrangements in the regulatory development process tend to aggravate both hidden 

policy judgments and science charades. They threaten the credibility of the scientific process and 

harm regulatory policy. Many of those involved in regulatory decisions have incentives to hide 

policy preferences, such as how to deal with the uncertainty in assessments of risk, and to 

dismiss and denigrate dissenting views. Key policy choices, disguised as science, too often rest 

with technical staff; meanwhile, policy makers charged with making hard policy decisions are 

able to avoid responsibility by claiming that their hands were tied by "the science." 

2. Risk Assessment and Risk Management 

Science is rarely sufficient for making policy decisions for two reasons. First, while science is 

essential for understanding the positive question of what is, or predicting what outcomes might 

obtain under different scenarios, it is not determinative for the normative decisions regarding 

what ought to be.6 Along these lines, in 1983 the National Research Council (NRC) of the 

National Academy of Sciences presented a framework for making regulatory decisions regarding 

health, safety, and environmental risks that separated decisions into two conceptual phases: risk 

assessment and risk management. 7 

2 See, for example, Jason Scott Johnston, ed. Institutions and Incentives in Regulatory Science. Lexington Books 

(2012) 

3 Lackey, Robert T. "Normative Science." Terra Magazine. Oregon State University. 2013;8(2). 4 Wagner, Wendy E. The Science Charade in Toxic Risk Regulation. Columbia Law Review. 1995 Nov;95(7): 

1614;29. 

5 Bipartisan Policy Center. Improving the Use of Science in Regulatory Policy. Washington (DC): Bipartisan Policy 

Center; 2009; I 0. Available at: 

http://www.bipartisanpolicy.org/sites/default/filcs/BPC%20Science%20Report%20fnl.pdf"BPC" 

6 See John Neville Keynes, The Scope and Method o(Politica/ Economy. Fourth Edition., Batoche Books: 

Kitchener, Ontario (1999), p. 22. 7 National Research Council and the Committee on the Institutional Means for Assessment of Risks to Public 

Health. Risk Assessment in the Federal Government: Managing the Process. 1983. Washington D.C.: National 

Academies Press, p. 3. This document is also commonly known as the "Red Book." 

Prepared Statement of Susan E. Dud ley, HSGAC Regulatory Affairs, March 9, 2017 

www.RegulatoryStudies.gwu.edu 
41 

The risk assessment phase provides science-based information regarding what we know about a 

risk (positive information regarding what is). While risk assessment is a necessary input for 

deciding how the government should regulate a risk, it is rarely sufficient. A second phase, risk 

management, is necessary for determining what ought to be. Sound policy decisions regarding 

risk management typically need to consider a host of non-scientific factors such as economic 

feasibility, legal constraints, ethical considerations, and the existence of other public policies that 

may address, or exacerbate, the risk, to name just a few. 

Unfortunately, in practice there is not a clear distinction between scientific and policy decisions 

in the regulatory process. First, when it comes to risk assessment, scientists will never have 

complete information to predict outcomes with certainty, so analysts rely on what the NRC 

called "risk assessment policy"- assumptions, judgments, and rules of thumb- to guide the use 

of scientific information in analyses that inform policy in the face of uncertainty. 8 "Risk 

assessment policy" includes various judgments, including which science is considered, how 

individual studies are weighed and combined, when competing theories are considered 

appropriately supported for inclusion, which models to use, and in general, what to do in the face 

of scientific uncertainty. It also guides the way in which risks are characterized and 

communicated. 9 In other words, the risk assessment phase itself embeds judgments necessary to 

produce a result that scientists can give to policymakers; and these judgments, intentionally or 

not, can bias the ultimate advice provided to decision-makers and the public. 

Policymakers and the public are often unaware of the influence of these risk assessment policy 

choices or the existence of alternative choices that are equally plausible. Instead, assessments 

often generate precise-sounding predictions that hide not only considerable uncertainty about the 

actual risk, but the reliance on biased inferences and assumptions for handling that uncertainty. 10 

While some judgment is necessary to translate scientific evidence into risk assessments, current 

risk assessment policies are not transparent, and lead to distortions in risk estimates and false 

precision in the presentation of scientific information. 11 As former EPA scientist Robert Lackey 

observed "[t]oo often, scientific information presented to the public and decision-makers is 

8 National Research Council and the Committee on the Institutional Means for Assessment of Risks to Public 

Health. Risk Assessment in the Federal Government: Managing the Process. 1983. Washington D.C.: National 

Academies Press, p. 3. 9 Dudley, SE & Gray, GM. "Improving the Use of Science to Inform Environmental Regulation," in Institutions and 

Incentives in Regulatory Science, Lexington Books, Jason Johnston ed. (20 12) 10 For example, EPA's "Risk Assessment Principles and Practices" document states: "[s]ince EPA is a health and 

environmental protective agency, EPA's policy is that risk assessments should not knowingly underestimate or 

grossly overestimate risks. This policy position prompts risk assessments to take a more 'protective' stance given the 

underlying uncertainty with the risk estimates generated." (USEPA 2004, 13-14) 11 Gray, G. & Cohen, J. "Rethink Chemical Risk Assessment." Nature. 2012 Sep; 489. P. 27.:"the problem is the 

EPA's use of assumptions that it claims are 'public health protective,' which err on the side of overstating risk when 

data are lacking .... Such inflated risk estimates can lead to overly stringent regulations and can scramble agency 

priorities because the degree of precaution differs across chemicals." 

Prepared Statement of Susan E. Dudley, HSGAC Regulatory Affairs, March 9, 2017 

www. RegulatoryStudies. gwu.edu 4 
42 

infused with hidden policy preferences," 12 a practice he calls "normative science." These hidden 

policy judgments obscure the boundary between science and policy, and contribute to the 

politicization of science through biased science advice. 

Presentations that are not transparent can mask normative science. For example, in its 2011 

evaluation of EPA's Integrated Risk Information System (IRIS) assessment for formaldehyde, 

the National Academy of Sciences raised concerns about recurring "problems with clarity and 

transparency of the methods": 

In general, the committee found that the draft was not prepared in a consistent 

fashion; it lacks clear links to an underlying conceptual framework; and it does 

not contain sufficient documentation on methods and criteria for identifYing 

evidence from epidemiologic and experimental studies, for critically evaluating 

individual studies, for assessing the weight of evidence, and for selecting studies 

for derivation of the [reference dose] RfCs and unit risk estimates. 13 

While embedded policy judgments raise concerns of hidden bias in the risk assessment phase of 

a rulemaking, policy judgments couched as "science" can raise similar problems in the risk 

management phase. 

While there should be a clear distinction in the minds of scientists and policymakers between 

describing what "is" and deciding what "ought to be," the two are sometimes unintentionally, or 

intentionally, conflated when the ultimate policy decision is presented as dictated solely by "the 

science." We adopt the phrase "science charade" 14 to describe the camouflaging of controversial 

policy decisions as science. 

Scientists and/or policymakers create a science charade by describing a policy decision in purely 

scientific (or scientific sounding) terms without revealing the trans-science 15 and policy factors 

that played a role in the decision. Scientists can unwittingly impose, or intentionally foist, 

science charades on decisionmakers by hijacking risk management decisions. Policymakers can 

create science charades on their own, or scientists and policymakers may cooperate in disguising 

value-laden decisions as the necessary result of "the best science." Regardless, the science 

12 Lackey 2013. 13 Committee to Review EPA's Draft IRJS Assessment ofFonnaldehyde; National Research Council. Review of the 

Environmental Protection Agency's Draji!RIS Assessment of Formaldehyde. Washington (DC): National Academy 

of Sciences; 2011: 4. Available at: http://www.nap.edu/catalog.php?record id-13142 14 See Wagner 1995. 15 Alvin M. Weinberg. "Science and Trans-Science." Science 177.4045 (1972): 211. Print. "!propose the term transscientific for these questions since, though they are, epistemologically speaking, questions offact and can be stated 

in the language of science, they are unanswerable by science; they transcend science ... Scientists have no 

monopoly on wisdom where this kind of trans-science is involved .... " 

Prepared Statement of Susan E. Dud ley, HSGAC Regulatory Affairs, March 9, 20 17 

www .RegulatoryStudies. gwu.edu 
43 

charade results in similar harms as hidden policy judgments in risk assessments: the public is 

cheated of sound and open policy making and the integrity of science advice is weakened. 

Both hidden policy judgments in risk assessments and science charades result from incorrectly 

mixing up positive information about what "is" with normative advice about what "ought to be." 

These errors are examples of the "is-ought fallacy." 16 Scientists and policymakers may 

intentionally invoke the is-ought fallacy, although for different reasons. Scientists may wish to 

influence policymakers by subtly absorbing nonscientific assumptions in their risk assessments 

or in descriptions of what "is" so that it appears there is no better risk management alternative 

than the one they prefer. Likewise, decisionmakers, such as political appointees, who may fear 

criticism of a particular decision can muddle descriptions of what "is" with assumptions 

regarding what "ought to be" in the risk management phase of rulemaking and claim that 

"science" dictated the outcome. In both cases, the fallacy allows scientists and/or policymakers 

to create a science charade by disguising a policy decision in a lab coat. 

3. The harms of politicized science and the example of NAAQS 

In a forthcoming article, Marcus Peacock and I use the process by which EPA sets National 

Ambient Air Quality Standards (NAAQS) for "criteria pollutants" 17 under the Clean Air Act to 

illustrate some of the perverse incentives involved in developing regulations, which can 

encourage biased science advice and a science charade. We found the NAAQS process 

particularly worth examining because, on the one hand it is held up by some as an ideal by which 

all science-based rulemaking should be developed, 18 but on the other, NAAQS decisions are 

among the most controversial of EPA policies. Each of the last three presidents has taken the 

highly unusual step of publicly and personally intervening in EPA's regulatory decisions. 19 

16 Also called the "naluralistic fallacy," the "positive-normative fallacy,'' Hume's Law and Hume's Guillotine. 17 The Clean Air Act, 42 U.S.C. § 7408 (a)( I) identifies six "criteria pollutants": particulate matter, ground-level 

ozone, carbon monoxide, sulfur oxides, nitrogen oxides, and lead. Available at: 

http://www.gpo.gov/fdsys/pkg!USCODE-2008-title42/pdf/USCODE-2008-title42·chap85.pdf 

18 Wendy Wagner. "Science in Regulation: A Study of Agency Decision making Approaches" (referring to the 

NAAQS development process as ~~the equivalent of a five-star process for incorporating science into regulatory 

policy.") 2013: 29. Available at: http://acus.gov/report/science-regulation-final-report 19 EPA's 1997 standards for ozone and fine particles were debated extensively at the cabinet level and, on issuance 

of the final regulations, President Clinton took the unprecedented step of writing a public memorandum to the EPA 

Administrator on "Implementation of Revised Air Quality Standards for Ozone and Particulate Matter," to "ensure 

that the new standards are implemented in a common sense, cost-effective manner." Available at: 

http://www.gpo.gov/fdsys/pkg/WCPD-1997-07-21/pdf/WCPD-1997-07-21-Pgl 080.pd0 (See Arthur Fraas, 

"Observations on O!RA's Policies and Procedures,'' Administrative Law Review, Vol. 63:20 II at 81-85 for an 

insider's account of the 1997 deliberations.) In 2008, EPA again faced objections from other agencies, as well as 

from state and local governments, when it proposed to revise the ozone standard. President George W. Bush was 

called in to settle the dispute, following the rarely used section 7 ofE.O. 12866 regarding the resolution of conflicts. 

He decided the dispute over the appropriate form of the welfare standard by directing EPA Administrator Stephen 

Johnson to set it at a level identical to the primary standard. Available at: 

http://www.reginfo.gov/public/postreview/Steve Johnson Letter on NAAOs final 3-13-08 2.pdfln2011, the 

President intervened again. EPA was poised to revise the ozone standard amid strong objections from other parts of 

Prepared Statement of Susan E. Dudley, HSGAC Regulatory Affairs, March 9, 2017 

www.RegulatoryStudies.gwu.edu 6 
44 

The Clean Air Act directs EPA to set NAAQS to "protect public health" with an "adequate 

margin of safety," but falls prey to the is-ought fallacy and encourages the science charade by 

restricting the agency from openly considering relevant nonscientific factors. Combined with 

tight deadlines, the statutory language permits Congress to take credit for laudable public goals, 

while blaming the executive branch's execution for any undesirable outcomes. The courts have 

reinforced a limited interpretation of the Act, as well as tight deadlines for issuing revised 

standards. Executive branch career and policy officials respond by hiding policy judgments and 

developing scientific-sounding explanations to justify one standard over another, and public 

interveners vigorously defend alternative standards based on their own interpretation of the 

"science." 

Scientists argue for the primacy of their data, analysts have an incentive to downplay rather than 

reveal uncertainties regarding their predictions or the implications of key risk assessment policy 

choices, and decision makers point to science as either requiring a new standard or as 

determining that existing standards are adequate. 

This has evolved into an adversarial process, characterized by harsh rhetoric in which each party 

claims the science supports its preferred policy outcome and questions opponents' credibility and 

motives, rather than a constructive discussion regarding appropriate data, assumptions and 

normative decisions. The real reasons for selecting a particular standard may not even be 

discussed. This harms the credibility of science advice and results in poorer decision making. 

4. Recommendations 

In thinking about reforms to improve how science is used in developing regulations, clarifying 

which aspects of the decision are matters of science and which are matters of policy is essential 

to avoid both hidden policy judgments and the science charade. When people condemn the 

"politicization" of science,20 the problem may really be that we ask too much of science in 

addressing policy problems. 

As the BPC recommended, a focus of reform should be on devising regulatory processes that, "in 

as many situations as possible, ... help clarify for both officials and the general public which 

aspects of disputes are truly about scientific results and which concern policy."21 This would not 

only help address the is-ought fallacy, but also the problem of hidden policy judgments, in which 

the effect of risk assessment policy judgments on estimates of outcomes are not acknowledged. 

the government and the regulated community, when President Obama took the unusual step of"request[ing] that 

Administrator Lisa Jackson withdraw the draft ozone NAAQS" from interagency review. Available at: 

http://www.whitehouse.gov/the-press-office/2011/09/02/statement-president-ozone-national-ambient-air-gualitystandards. This is the only time during President Obama's administration that the White House returned a regulation 

to an agency. 20 Mooney, C. The Republican War on Science. New York: Basic Books; 2006. 21 Bipartisan Policy Center, 2009:4. 

Prepared Statement of Susan E. Dudley, HSGAC Regulatory Affairs, March 9, 2017 

www.RegulatoryStudies.gwu.edu 7 
45 

"This transparency would both help force values debates into the open and could limit spurious 

claims about, and attacks on, science."22 

In our forthcoming article, Marcus Peacock and I offer a set of recommendations that attempt to 

alter the incentives of the parties to the rulemaking process to I) address behavior contributing to 

the is-ought fallacy, 2) address the problem of hidden policy judgments, and 3) improve 

incentives generally. The following eight suggestions are based on that article. 

1. Recognize that "science" is a positive discipline that can inform, but not decide, 

appropriate policy. 

In drafting authorizing legislation, Congress should not delegate decisions to agencies on the 

pretense that science alone can make the normative determination of what policy ought to be. 

Some statutes directed at health, safety, and environmental risks have facilitated more rational 

regulatory policy than others by recognizing that risk management requires normative judgments 

that consider tradeoffs. For example, the Safe Drinking Water Act requires EPA to consider the 

costs as well as the benefits of requiring local water authorities to install controls for specific 

substances. Perhaps that is one reason why the debates over drinking water standards are 

generally less acrimonious than debates over ambient air quality standards. Since the statute 

allows explicit consideration of tradeoffs when setting standards, the full burden of decisionmaking is not vested in the risk assessment. As a result, policy makers and interested parties may 

have less incentive to embed policy preferences in the risk assessment portion of the analysis, 

because they can debate them openly and transparently in the risk management discussion.23 

2. Legislators and policymakers must clarify the appropriate role for scientific 

advisors. 

The engagement of scientific advisory panels can provide a necessary and valuable source of 

information and peer review for agency science, but greater efforts should be made to restrict 

their advice to matters of science, and not ask them to recommend regulatory policies. When 

asked to advise on policy choices, it is impossible for members not to be tempted to wrap their 

policy views in a lab coat and present them as scientific recommendations.24 As reports from 

both the BPC and the Keystone Center25 emphasized, the questions posed to such panels "should 

22 Bipartisan Policy Center, 2009:5. 23 Dudley & Gray, 2012. 24 See, for instance, the recommendation of former CASAC member Morton Lippman regarding changing the Clean 

Air Act. Lippman noted "CASAC's role must be limited to highlighting the issues at the science-policy interface 

and the scientific knowledge that informs these issues." Dr. Morton Lippman. "Comments on the NAAQS Review 

Process." 2006, at A-22. http://yosemite.cpa.gov/sao/sabproduct.nsfiWebCASACNanessa%20Memo 03-l6-

Q6/$File/sabso-casac memo and comments.pdf 25 The Keystone Center. Research Integrity Roundtable. Improving the Use of Science in Regulatory Decision 

Making: Dealing with Conflict oflnterest and Bias in Scientific Advisory Panels, and Improving Systematic 

Scientific Reviews. Washington (DC): The Keystone Center; 2012. Available at: 

Prepared Statement of Susan E. Dudley, HSGAC Regulatory Affairs, March 9, 2017 

www. RegulatoryStudies. gwu.edu 
46 

be clearly articulated, and 'explicitly differentiate, to the extent possible, between questions that 

involve scientific judgments and questions that involve judgments about economics, ethics, and 

other matters of policy."'26 Experts with formal training and experience in policy analysis, 

economics, law, and other disciplines are much better equipped to provide advice on these latter 

questions. 

3. Establish procedures and incentives to make more transparent the effect different 

credible risk assessment inputs and assumptions have on the range of plausible 

outcomes. 

Risk assessments necessarily involves assumptions and judgments as well as pure scientific 

inputs, yet they often generate precise-sounding predictions that hide not only considerable 

uncertainty about the actual risk, but hidden policy judgements.27 One way to make risk 

assessment policy choices more transparent to decisionmakers and the public would be for 

agency scientists to calculate and present multiple risk estimates based on a variety of 

scientifically plausible data sets, endpoints, models, etc., 28 rather than embedding multiple risk 

assessment policy choices in a single assessment. 29 Greater transparency regarding the 

assumptions and policy rationales for choosing one set of assumptions or models over another 

would encourage more openness and constructive discussion about science and policy, 

improving the ultimate policy decision and probably engendering greater acceptance of that 

policy choice. 30 

4. Institutionalize reforms that encourage greater feedback and challenge of risk 

assessment practices and policy choices. 

The scientific method depends on falsifiable hypotheses, data gathering, replication, dissent, and 

challenge, to ensure objective analysis to minimize bias in the interpretation of results. 

Institutional reforms that intentionally engage, rather than avoid, competing views, could go a 

long way to improve the clarity of the risk assessment process and the decisions that depend on 

scientific input. Successful reforms might involve pre-rulemaking disclosure of risk assessment 

information to engage broad public comment on the proper choice of studies, models, 

https ://www .keystone.org!i mageslkeystone-center/spp 

documents/Health/Research%201ntegritv%20Rountable%20Report.pdf 

26 The Keystone Center, 2012: 8. (Internal citation to BPC at 5.) 27 Dudley et al, "Consumers Guide to Regulatory Impact Analysis: Ten Tips for Being an Informed Policymaker," 

GW Regulatory Studies Center Working Paper, February 2, 2017. Available at: 

httos://regulatorystudies.columbian.gwu.edu/consumcr"/oE2%80%99s-guide-regulatory-impact-analysis 

28 Dudley & Gray 2012 29 Lackey, 2013. 30 Dudley & Gray, 2012. 

Prepared Statement of Susan E. Dudley, HSGAC Regulatory Affairs, March 9, 2017 

www.Regul atoryStudics. gwu.edu 9 
47 

assumptions, etc. long before any policy decisions are framed, and "positions" established. 31 

Advanced notices of proposed rulemaking could be used effectively to gather such input. 32 

5. Scientific advisory panels should be required to represent a diversity of 

perspectives, disciplines, expertise, and experience. 

The 2012 Keystone Group report offers a series of recommendations on "the composition of 

committees that are empaneled to review the science behind a regulatory decision."33 

Acknowledging the importance of choosing panelists that "have the knowledge, training, and 

experience needed to address the charge to the panel,"34 it admonished agencies "to recognize 

that all potential panelists will have conscious and unconscious biases," and said that "the panel 

selection process requires review of the disclosed information and a judgment as to the ability of 

each prospective panelist to participate in open discussion and to consider other perspectives."35 

6. Encourage feedback through retrospective review of regulatory outcomes. 

Regulatory programs are rarely subjected to rigorous evaluation and feedback. Most regulatory 

analyses rely on models and assumptions to make predictions about the risk reduction benefits 

that will accrue from a specific intervention. Institutionalizing a requirement to evaluate whether 

the predicted effects of the regulation were realized would provide an incentive to improve the 

use of science for predicting the benefits of interventions. Agencies should be required to include 

in proposed regulations a framework for empirical testing of assumptions and hypothesized 

outcomes. 36 To incentivize more robust evaluation, agencies could be required to test the validity 

of risk-reduction predictions before commencing new regulation that relies on models. 

7. Regulations should be designed to facilitate natural experimentation and learning. 

Designing regulations from the outset in ways that allow variation in compliance is essential if 

agencies are to go beyond observing mere associations and gather data necessary to test 

hypotheses of the relationship between regulatory actions, hazards, and risks. Quasi-experiments, 

31 Balla, Steven J. and Dudley, Susan E. "Stakeholder Participation and Regulatory Policymaking in the United 

States." A report prepared for the Organisation for Economic Co-operation and Development. 2014. 

http://regulatorystudies.columbian.gwu.edu/sites/regulatorystudies.columbian.gwu.edu/files/downloads/BallaDudley-US-Stakeholder-Reg-Process-ll-20 14.pdf 32 See, for example, S. 1820, "Early Participation in Rulemaking Act of2015." https://www.congress.gov/bill/ll4thcongress/senate-bill/l820/text 

33 Keystone, 2012:4. 34 Keystone, 2012:14 35 Keystone, 2012: 15 36 For example, see S. 1817, "Smarter Regs Act of20 15," https://www.congress.gov/bill/ll4th-congress/scnatebill/18!7/text 

Prepared Statement of Susan E. Dudley, HSGAC Regulatory A flairs, March 9, 2017 

www. Re gulatoryStudies. gwu.edu 10 
48 

relying on differences in treatments (such as differences in attainment status with NAAQS) can 

inform risk assessments going forward. 37 

8. Greater weight should be placed on scientific studies that were subject to peer 

review and whose results are reproducible. 

Peer review is often considered a fundamental component of the scientific process and scientific 

publishing is focusing more on the sharing of data and experimental transparency. 38 Disclosure 

of underlying data and computer code has become standard among the more prestigious 

scientific and technical journals, which allow for data sharing agreements when individuallyidentifiable information prevents public disclosure. 39 These disclosure policies appear to 

improve the reproducibility of the results of published papers. 40 

* * * 

No one is immune to the temptation to spin science to advance a pre-determined policy goal. 

However, masquerading policy preferences as "science" can be extremely harmful. As former 

Assistant Administrator of the U.S. Environmental Protection Agency, Milton Russell, has noted, 

while government scientists need to be protected from "influence over what they find and 

report," "policy-makers must be protected from policy analysts or scientists telling them what 

they should decide, but open to information about what the consequences of alternative decisions 

are likely to be."41 

Current regulatory institutions and procedures tend to aggravate two contributors to the 

politicization of science: "hidden policy judgments" (not acknowledging the policy judgments 

inherent in risk assessment) and "science charades" (camouflaging policy decisions as science). 

Both of these problems threaten the credibility of the scientific process and harm regulatory 

policy. 

37 For an illustration of this method applied to the competitive effects ofNAAQS, see Greenstone, M., List J.A., 

Syverson, C. "The Effects of Environmental Regulation on the Competitiveness of U.S. Manufacturing." MIT 

Center for Energy and Environmental Policy Research working paper. CEEPR WP 2012-0 13; 2012. 38 Joel Achenbach, "The new scientific revolution: Reproducibility at last." Washington Post. January 27,2015. 39 Dudley et al, 2017, Tip 6. 40 Randall Lutter and David Zorn. 2016. "Reinforcing Reproducibility: What Role for the Federal Government?" 

RegulationWinter2015-16: 15-16. 

https://o bject.cato .orglsites/cato .org/files/serial s/files/regulation/20 15/12/regulation-v38n4-8 4.pdf#page= 1 0. 41 Milton Russell, "Lessons from NAPAP," Ecological Applications, 2(2), 1992, p. 108. -

Prepared Statement of Susan E. Dudley, HSGAC Regulatory Affairs, March 9, 2017 

www.RegulatoryStudies.gwu edu 11 
49 

Written Testimony of Andrew A. Rosenberg, Ph.D. 

U.S. Senate Subcommittee on Regulatory Affairs and Federal Management 

"Agency Use of Science in the Rulemaking Process: Proposals for Improving Transparency and 

Accountability" 

March 9, 2017 

Chairman Lankford, Ranking Member Heitkamp, and Members of the Senate Homeland 

Security and Governmental Affairs Subcommittee on Regulatory Affairs and Federal 

Management: 

Thank you for the opportunity to testify today to discuss the important role that science plays in 

the rulemaking process. I am Dr. Andrew Rosenberg, Director of the Center for Science and 

Democracy at the Union of Concerned Scientists. I have more than 25 years of experience in 

government service, academia, private sector consulting, and non-profit leadership, have 

authored over l 00 peer reviewed papers, as well as numerous national and international scientific 

reports on fisheries and ocean science policy, and on the intersection between science and 

policymaking. 

Within the U.S. government, I have served as a scientist and regulator under both Democratic 

and Republican administrations, including as the Deputy Director of National Oceanic and 

Atmospheric Administration's (NOAA) National Marine Fisheries Service. I have also taught in 

academia for more than ten years, and was the former Dean of Life Sciences and Agriculture at 

the University of New Hampshire. Since 2012, I have directed the Center for Science and 

Democracy at the Union of Concerned Scientists. 

The Union of Concerned Scientists puts rigorous science into action for a healthier planet and a 

safer world. Our staff includes scientists, engineers, economists, and analysts working to address 

some oftoday's most pressing problems. Backed by a network of more than a half-million 

supporters and some 20,000 scientists and technical experts across the country who are a part of 

our Science Network, we believe that scientific analysis should guide government policies. For 

nearly 50 years, UCS has championed and continues to advocate for the need to base our 

governmental decisions on the best scientific and technical information available. 

The Center for Science and Democracy at the Union of Concerned Scientists works to 

strengthen the role science plays in policy and community decisions. We work to ensure that 

policymakers and the public have access to the independent scientific information needed to 

make informed decisions about public health, safety, and the environment. Furthermore, we 

lay out a positive vision of how independent science and scientists can be made more 

impervious to political influence, such as implementing strong scientific integrity policies 

and maintaining strong conflict of interest standards at federal agencies and federal scientific 

advisory boards. 
50 

Science in the Policy-making Process 

Science plays a critical role in the policy decisions made by the federal government that impact 

Americans' health and safety, from ensuring that drugs are proven to be safe and effective, to 

keeping our food free of disease, to keeping our drinking water clean, to assuring safe working 

conditions for workers, and protecting our natural resources. While these decisions are not made 

based on scientific and technical assessments alone, technical input is integral to the regulatory 

process. Science provides government agencies and the public the ability to assess public health, 

safety, and environmental threats, evaluate the impacts of possible policy responses, and make 

informed decisions to protect the public interest. Science allows us to monitor ongoing results 

and emerging concerns on a wide range of issues from rapidly proliferating infectious diseases to 

dangerous and pervasive air pollutants. Using science to inform policy decisions and involving 

the public throughout the decision-making process is critical for public trust in the operations of 

the government and upholds our democratic principles. My experience as a scientist and manager 

has affirmed that good governmental decisions require the best scientific and technical 

information available, unfettered by political, financial, or ideological influence. 

The scientific process consists of continuous and incremental discoveries in multiple fields of 

study accumulating a weight of evidence and building toward broad acceptance of facts within 

the scientific community. 

Weight of the evidence refers to the cumulative body of scientific research and analysis that 

pertains to a particular subject. "Weight" refers not only to the number of studies but also their 

importance, robustness, and credibility in drawing scientific inference. Credibility relates to the 

desigu of the study, analytical methods and methods of inference, as well as the provenance of 

the work with regard to potential conflicts of interest, peer reviews conducted, and comparison to 

other relevant studies. These elements are a key part of the scientific process. 

A valid and credible scientific process consists of a rigorous examination of ideas, review, and 

critique by technically qualified peers, open exchange of ideas among colleagues, and protection 

against manipulation of results by vested interests or retaliation for one's scientific findings. 

Freedom to participate in the scientific process ensures that technological innovations and 

attendant benefits to society are supported and protected. 

Some environmental statutes require that agencies make decisions based solely on the best 

available science while others require science to be used in certain discrete parts of the 

regulatory decision. For example, the Clean Air Act requires National Ambient Air Quality 

Standards be set using the best available science on the link between air pollutants and health 

effects, but allows for other considerations including economic factors when implementing the 

standards. It is, of course, the agency's responsibility, with input from qualified scientific 

2 
51 

advisers, to abide by their statutory obligations when conducting rulemaking and to consider the 

weight of the evidence as required by law. 

I serve as a regular reviewer for several scientific journals, as a member of two editorial boards, 

and as an independent reviewer for national and international reports (e.g. from governments or 

United Nations bodies). In this capacity, I consider the framing of a study, the methods, the 

results, and the researcher's interpretation in light of my knowledge of the field and relevant 

scientific literature. I may not agree with all inferences drawn by the researchers in the 

discussion, but if the aforementioned components are well executed, then a paper merits 

publication in my view. Every paper is subtly different and should be judged by experts in the 

field on its merits. This is generally true of the science used in the regulatory process as well. 

Here, the question arises, what is best available science? And what is independent science? In 

my view, and the view of most of the scientific community, best available science is research 

that is conducted in accordance with well-established scientific practices, including a welldesigned investigation, logical and statistically rigorous analysis, clear documentation of data 

collection and analytical methods, as well as results free from external influences that may 

support a particular policy position, and careful peer review. I strongly believe that these 

generally accepted standards cannot be clearly legislated without undermining innovation and 

accounting for the broad array of scientific methods. 

Science is an ever-evolving process. Legislating what is considered to be the "best available" 

removes the process of science from scientists and puts it in the hands of legislators and the 

courts. As former congressman and current chief executive officer of the American Association 

for the Advancement of Science (AAAS) Rush Holt told the House Committee on Science, 

Space, and Technology earlier this year: 

"Legislation removing concepts like reproducibility and independent analysis from the 

hands of scientists and into a legislative chamber or a court room would truly have a 

chilling effect on the scientific process and reduce the benefits that science could bring to 

society. Seeking to influence the scientific process has no place in how a government or 

other entity should conduct science."1 

Furthermore, if one were to legislate what should be legally considered "best available science," 

it would prevent the innovation and flexibility that is inherent in the scientific process. This 

ability to learn is essential for agencies as they address new discoveries like autonomous vehicles 

and advancements in nanotechnology. As we learn more, science continues to evolve. New 

research leads to a better understanding of complex challenges that we face today, allowing 

experts to make appropriate determinations, sometimes erring on the side of caution when faced 

with uncertainty or limited data to best protect the public. 

3 
52 

When I was working as a lead regulator in the Northeast, research findings from federal, state, 

and academic scientists on New England and mid-Atlantic fisheries indicated an overexploitation 

of the resource. While of course there was uncertainty in the exact status of fishery resources, the 

risk of not taking action with regard to public trust resources outweighed the uncertainty. The 

fishing industry and other members of the public had ample opportunity to present their views 

and evidence. Opinions of those in the industry were very influential in the process, alongside 

the science. But the scientific evidence that accumulated over many years ultimately led us to 

take measures to curb overfishing with the result that some of the fish stocks recovered and now 

support vibrant fisheries. 

While it is important to document where the uncertainty lies, it is also necessary to act once the 

weight of evidence is compelling enough to justifY reasonable, evidence-based policy solutions. 

The weight of scientific evidence cannot be tilted with just one study. A poorly conducted study, 

unduly influenced by a vested interest, should not be equally considered along with the multitude 

of peer reviewed and well-executed studies. 

As I noted, peer review is a critically important quality control mechanism if it is well conducted. 

But, make no mistake, it is possible to misuse the process. A case in point is that tobacco 

company, Phillip Morris, used a phony peer review process to falsifY research in an effort to stop 

or circumvent regulations around light cigarettes and their relationship to nicotine addiction, tar 

consumption, and disease, including cancer. The company hired scientists from industry-friendly 

consulting firms to publish a study in Regulatory Toxicology and Pharmacology, which had a 

record of publishing research paid for by industry.2 It used this published study which underwent 

conflicted peer review, to dispute the scientific consensus on the harms oflight cigarettes and the 

findings of the Surgeon General, the National Academy of Sciences, the National Cancer 

Institute, and the American Cancer Society, whose research found that lung cancer mortality 

rates among smokers increased after light cigarettes began dominating sales. 3 In this case, the 

degree to which the tobacco industry paid for and influenced the research demonstrated a clear 

conflict of interest, limiting the credibility of the study. The telling analysis of this study's 

diminished credibility was accomplished not by reviewing raw data, but through an examination 

of the conflicts of interest and the methodology. 

Public Access to Science 

We are probably all in agreement that public access to the science that underlies regulatory 

decisions is important so that the public can fully engage in the democratic process and to ensure 

that the rationale for decisions is clear, even if we all don't agree with the final policy outcome. 

However, access to critical scientific information must be granted only while maintaining 

necessary confidentiality and respecting privacy concerns. 

4 
53 

On this point, it is important to distinguish between data and science. The scientific information 

critical for an informed public is information on how studies are conducted, how the information 

is interpreted, and inferences that are drawn. This is not dissimilar to the information a peer 

reviewer like me considers in evaluating a study, albeit for the public in a non-technical form. I 

cannot think of an example of a peer reviewer requiring access to raw data in reviewing a study. 

Access to underlying data may of course be important for other researchers to use in their own 

studies as the scientific process proceeds. I have analyzed long-term datasets that were collected 

by others in many studies. Access to that data must respect confidentiality provisions, intellectual 

property, commercial confidentiality, and of course the opportunity of the original researchers to 

publish their results first. Confidentiality is critical and required by research institutions, through 

their Institutional Review Boards, for any studies including people. For example, medical data 

relied upon by public health researchers and used by agencies may not be publicized because of 

sensitive, personal information and other legal violations. As noted above it is important to 

distinguish between raw, confidential data and scientific analyses that might be used by an 

agency in the analysis of public health and safety protections. 

Legislation like the Honest and Open New EPA Science Treatment Act of 2017 is misleading 

and fails to adequately address this distinction. It would effectively disallow agencies from using 

protected raw data and thereby restrict the government's ability to meet its statutory obligations 

based on science to protect public health and the environment. Most critical and illogically, the 

result would be that the public would not be protected from genuine threats to health and safety 

because of restrictions in data access protecting the privacy of members of the public. Further, 

such restrictions would increase costs and burdens to agencies, while undermining the ability for 

agencies to make decisions based on incredibly important research using confidential public 

health information. This is all to no purpose, since the raw data is not needed in order for the 

public to be informed about scientific information. 

For example, the landmark Harvard Six Cities study published in 1993 relied upon longitudinal 

cohort data using individuals' medical and occupational histories as well home air quality data in 

order to study the association between chronic exposure to air pollution and mortality in six 

major U.S. cities.4 This study was one of many assessments used by the Environmental 

Protection Agency (EPA) in determining the need for new particulate matter standards to 

improve health outcomes in the United States.5 However, some elected officials have politicized 

this study, calling its data "hidden" and asking the EPA to provide the raw data for "independent 

scientific verification," despite the study having been peer reviewed and subsequently reanalyzed 

by independent researchers. 6 But in order for the scientific process to work, the rights and 

privacy of study participants must be protected and the analyses based on these data must be 

used by agencies using a credible scientific process. If citizens did not feel !ike their private 

health information could be protected, they would not volunteer for these types of studies that 

help federal and state agencies ensure the strongest public health safeguards for all Americans. 

5 
54 

There are other reasons as well, for not allowing unlimited access to underlying data. For 

example, the underlying data can be proprietary in nature, whether it is being shared with federal 

agencies by regulated industries, other private entities, or scientists who are conducting their own 

research. To return to my own direct experience as a regulator, fishermen and others who work 

on the water are intensely protective of data about their activities. And public access to raw data 

is unnecessary for people to understand the scientific analyses underpinning regulations. But 

requiring public access to some data would potentially disadvantage some businesses. 

A Framework for Independent Science in Rulemaking 

A coherent, publicly credible and acceptable framework to assure that scientific advice is 

independent is needed as an antidote to vested interests seeking to use science to justifY predetermined policy positions for economic, political, or ideological gain. Agency rulemaking 

must be informed by independent scientific advice that is free from political pressure. As stated 

earlier, components of independent science include peer review, disclosure of potential conflicts 

of interest, public availability of research findings and methodology, freedom to publish 

research, and mitigation of scientific misconduct. 

Agencies have procedures in place that facilitate best practices to advance the role of science in 

the rulemaking process. Twenty-four federal agencies have developed scientific integrity policies 

in response to a 2009 White House directive, many of which provide the protections necessary to 

foster a culture of scientific integrity at federal agencies. 7 There is now legislation in both the 

House and Senate that would enshrine the requirement that the scientific integrity policies 

remain in place, which I view as a positive step to protect science-informed policymaking. 

Further, many government agencies, including the EPA, NOAA, the U.S. Fish and Wildlife 

Service, the National Institutes of Health, and the Centers for Disease Control and Prevention, 

also have strong peer review policies that encourage rigorous and transparent scientific analysis 

and further safeguard the government scientific process.8 When free from undue influence, the 

scientific process and its ability to inform government decisions works well, but this process can 

still be undermined by political interference. 

Examples of political interference in the rulemaking process can include manipulating scientific 

or technical results, selectively editing agency scientific documents, exaggerating uncertainty 

while downplaying what is known, tampering with scientific procedures, intimidating, censoring 

or coercing scientists, suppressing scientific findings, disregarding scientific findings when 

legally mandated to consider them, and allowing conflicts of interest in decision-making 

processes.9 Scientific integrity policies at departments and agencies help to minimize 

interference in the role of science in the regulatory process and create a culture of scientific 

integrity within the government. Engagement of the public and ensuring access to scientific 

information (not raw data) throughout the regulatory process also enhances the role of science in 

our democracy. 

6 
55 

Agencies should use the best available scientific information in rulemaking as guided by their 

missions and statutory obligations. "Best available" should be used to describe the weight of 

evidence which only includes science developed by a credible process for ensuring 

independence from undue influence by vested interests. Agency scientists, supported by a 

commitment to a rigorous independent science, scientific integrity policies, and appropriate 

transparency measures, should be trusted to analyze available data and issue policies that 

consider and value the weight of the evidence. All Americans benefit when science is used to 

inform policy, and its integrity in the rulemaking process is imperative for a functional 

democracy and a safer, cleaner environment for all. 

Mr. Chairman, Ranking Member, and members of the committee, I appreciate the opportunity to 

share my views and I am happy to answer any questions. 

1 Holt, R. Testimony Before the Committee on Science, Space and Technology. February 7. 2 Heath, D. Contesting the Science of Smoking. 2016. The Atlantic, May 4. Online at 

www.theatlantic.com/politicslarchive/2016/05/low-tar-cigarettes/481116!, accessed March 1, 2017. 3 U.S. Surgeon General. 2014. The Health Consequences of Smoking-50 Years of Progress: A Report of the 

Surgeon General, 2014. Online at www.surgeongeneral.gov/librarylreports/50-years-oj-progressl, accessed March 

1, 2017; Institute of Medicine. 2001. Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction. 

National Academy Press: Washington, D.C.; U.S. Department of Health and Human Services, National Institutes of 

Health, National Cancer Institute. 200 I. Risks Associated with Smoking Cigarettes with Low Machine-Measured 

Yields of Tar and Nicotine. Smoking and Tobacco Control Monograph No. 13. Bethesda, MD, November; Thun, 

M.J., C.A. Day-Lally, E.E. Calle, W.D. Flanders, and C.W. Heath, Jr. 1995. Excess mortality among cigarette 

smokers: changes in a 20-year interval. American Journal of Public Health, 85(9): 1223-1230, September. 4 Dockery, D.W., C.A. Pope, X. Xu, J.D. Spengler, J.H. Ware, M.E. Fay, B. G. Ferris, Jr., and F.E. Speizer. 1993. An 

Association between Air Pollution and Mortality in Six U.S. Cities. New England Journal of Medicine, 329: 1753-

1759. doi: 10.1056/NEJM19931209329240l. 5 U.S. Environmental Protection Agency, Office of Air and Radiation. 2011. The Benefits and Costs of the Clean 

Air Act from 1990 to 2020, Revision A. Online at www.epa.gov/sites/production(files/2015-

f71documents/fullreport_rev_a.pdf, accessed March 1, 2017. 

Rowland, C. 2013. House GOP demands Harvard Study data. Boston Globe, September 7. 7 Goldman, G.T., E. Berman, M. Halpern, C. Johnson, Y. Kothari, G. Reed, and A.A. Rosenberg. 2017. Ensuring 

scientific integrity in the age of Trump. Science, 355(6326): 696-698, February 17. 8 Goldman, G., G. Reed, M. Halpern, C. Johnson, E. Bennan, Y. Kothari, and A. Rosenberg. 2017. Preserving 

scientific integrity in federal policymaking: lessons from the past two administrations and what's at stake under the 

Trump Administration. Cambridge, MA: Union of Concerned Scientists. Online at 

www. ucsusa.orglsites/default(files/attach/20 1710 I !preserving-scientific-integrity-in:federal-policymaking-ucs2017.pdf, accessed March l, 2017. 9 Grifo, F., T. Donaghy, P. Baur, M. Halpern, K. Kaufman, M. McCarthy and C. Wexler. 2008. Federal science and 

the public good: Securing the integrity of science in policy making. Cambridge, MA: Union of Concerned Scientists. 

Online at www.ucsusa.orglsitesldefault(files/legacylassetsldocuments/scientific _integrity/Federal-Science-and-thePublic-Good-12-08-Update.pdf, accessed March I, 2017. 

7 
56 

merican· 

Chemistry 

ouncil 

Written Statement of 

Nancy B. Beck, Ph.D., DABT 

Senior Director of Regulatory & Technical Affairs 

American Chemistry Council 

Before the 

U.S. Senate Committee on Homeland Security and Governmental Affairs 

Subcommittee on Regulatory Affairs and Federal Management 

Regarding a Hearing on the Agency Use of Science in the Rulemaking Process: 

liP age 

Proposals for Improving Transparency and Accountability 

March 9, 2017 

American Chemistry Council 

700 2nd Street, N.E. 

Washington, D.C. 20002 
57 

Summary 

The American Chemistry Council (ACC) 1 appreciates this opportunity to provide testimony on 

Federal Agency use of science in the rulemaking process, and particularly on proposals for 

improving transparency and accountability. 

The business of chemistry is a critical component for manufacturing safe, high quality products 

and ACC member companies rely on science to conduct the research necessary to discover new 

chemistries and identify new applications of existing chemistries. They also rely on science to 

develop new tools for assessing the potential hazards, exposures and risks of chemical 

substances. Similarly, they expect high quality, up to date science and relevant reliable 

assessment processes to underpin regulatory decisions by the Federal government. 

Reliance on the highest quality, best available science is critical to ensuring public trust. Without 

it, consumers are at a severe disadvantage. Stakeholders can lose confidence in regulatory 

decision making, which in turn can lead to product de-selection that is not supported by science, 

unwarranted public alarm and unnecessary costs. 

ACC supports actions to enhance the integration of the best available scientific knowledge and 

weight ofthe evidence methods as the foundation for regulatory decision making across Federal 

Agencies. We also support improving the technical quality and objectivity of Agency 

evaluations, particularly through enhancing the transparency of how the science is being 

considered, interpreted, and evaluated. 

In 2002, Federal Agencies were directed to ensure the quality, objectivity, utility and integrity of 

information which they disseminated to the public.2 In theory, this should have had a direct 

impact on improving the quality of scientific analyses that support regulatory decisions. 

Unfortunately, while most Agencies have committed to meeting these standards, we have seen 

that some of the scientific analyses that have come out of the EPA and other Federal Agencies 

fall short of meeting the objectivity and quality standards discussed in the government-wide 

Information Quality Guidelines. 

1 ACC represents the leading companies engaged in the business of chemistry. ACC members apply the science of 

chemistry to make innovative products and services that make people's lives better, healthier and safer. ACC is 

committed to improved environmental, health and safety performance through Responsible Care®, common sense 

advocacy designed to address major public policy issues, and health and environmental research and product testing. 

The business of chemistry is a $797 billion enterprise and a key element of the nation's economy. It is the nation's 

largest exporter, accounting for fourteen percent of all U.S. exports. It is also one of the nation's most heavily 

regulated industries. Chemistry companies are among the largest investors in research and development. 2 Pursuant to what is commonly referred to as the Information Quality Act (Sec. 515 of the Treasury and General 

Government Appropriations Act for FY 2001, Pub. L. No. 106-554), the Office of Management and Budget (OMB) 

issued government-wide Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of 

Information Disseminated by Federal Agencies (2002), 67 Fed. Reg. 8452 (Feb. 22, 2002) [hereinafter Information 

Quality Guidelines], available at: 

https://georgewbush-whitehouse.archives.gov/omb/memoranda/fy2007/m07-24.pdf; 

21Page 
58 

ACC's testimony today discusses some of the standards that already exist, discusses the new 

Lautenberg Chemical Safety Act scientific standards, and provides some suggestions for 

ensuring the quality of science that supports regulatory activities. We also share examples of 

where some Agencies' scientific evaluations continue to fall short. 

I. The Need for Confidence in Science 

As we are all aware from the news media, there is a large public perception that science may not 

inform Federal Agency decision making. Indeed even organizations like the American 

Association for the Advancement of Science (AAAS) have now become official partners in the 

planned Apri122, 2017 March for Science. Dr. Rush Holt, the CEO of AAAS has stated "We see 

the activities collectively known as the March as a unique opportunity to communicate the 

importance, value and beauty of science. "3 Concerns about confidence in science, particularly to 

inform regulations, is not new and certainly did not begin with the 2016 elections. 

In 2013, George Mason University conducted a survey to help capture the viewpoints of the 

scientific community on the state of regulatory risk assessment. The survey "Expert Opinion on 

Regulatory Risk Assessment" reached out to all members of the Society of Toxicology Risk 

Assessment Specialty Section, the Society for Risk Analysis Dose Response Section and the 

International Society for Regulatory Toxicology and Pharmacology.4 The survey focused on how 

well and how frequently critical parts of a risk evaluation were conducted (e.g., was there a 

problem formulation, were standardized protocols used for data collection, was a weight of 

evidence approach used, was peer review sufficient). In general, the findings showed that there is 

widespread concern over the current application of these procedures and also showed concerns 

about the amount of attention given to scientific factors in risk management.5 

In July 2016, almost 200 toxicologists signed "an appeal for the integrity of science in public 

policy."6 This appeal urges legislators to embed the "rules of evidence" of the scientific method 

in statutes governing administrative policy and regulations. These scientists are concerned that 

precautionary regulations and policies are being presented as objective science, when in reality 

they are not. In another recent article, Dr. Andrew Rosenberg of the Union of Concerned 

Scientists stated, "When science is sidelined from policy decisions, we alllose."7 ACC shares 

the concerns and recommendations of this diverse set of scientists. Too often we see scientific 

assessments, or even policies, that are driven by default assumptions rather than actual scientific 

evidence. 8 

ACC has consistently called upon the EPA to improve the design and conduct of its chemical 

assessments. In 2014, ACC released Principles for Improving Chemical Hazard and Risk 

3 See Science Magazine, Feb 28, 2017 article available at: http://www.sciencemag.org/ncws/2017/02/will-they-orwon~t~they·what-science-groups-are-saying-about-joining-march-science. 

4 The Survey and results can be found at: https:l/cmpa.gmu.edu/wp-contentluploads/2013/12/GMU-StudyReport.pdf. 

5 Ibid at page 2. 6 See article available at: htto://www.sciencedirect.com/science/article/pii/S0300483X 16301123. 7 See Science Magazine, Feb 17, 2017 article available at: http://science.scicncemag.org/content/355/6326/696/tabpQf 

'See NIOSH Carcinogen Policy example provided in Appendix I of this testimony. 

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Assessments.9 ACC did not invent these principles. For years, authoritative bodies, like the 

National Academy of Sciences (NAS), have provided similar constructive input to the EPA. 10 

Appendix I of this testimony provides some specific examples of cases where Federal Agency 

evaluations have not met scientific standards. 

II. Tools and Standards Exist to Improve Agency Science 

Improving Federal Agency science should not be as challenging as it has been. Significant 

governmental and non-governmental guidance already exists. As noted below, often this 

guidance is not followed. 

a. Information Quality Guidelines 

In 2002, the Office of Management and Budget (OMB) released the Guidelines for 

Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity ofinformation 

Disseminated by Federal Agencies (Information Quality Guidelines). 11 The guidelines 

were then adopted by Federal Agencies and the OMB's principles were to be reflected in 

the agency-specific guidelines. 

With regard to the analysis of risks to human health, safety and the environment, 

Agencies have adopted or adapted the quality principles applied by Congress to risk 

information used and disseminated pursuant to the Safe Drinking Water Act (SDWA) 

Amendments ofl996 (42 U.S.C. 300g-l(b)(3)(A) & (B)). In these amendments, 

Congress emphasized that EPA must use the best available scientific evidence for risk 

information. Since the Information Quality Guidelines directed all Agencies to adopt this 

standard, Agencies were directed, "to the degree that an Agency action is based on 

science," to use: 

(i) the best available, peer-reviewed science and supporting studies conducted in 

accordance with sound and objective scientific practices; and (ii) data collected by 

accepted methods or best available methods (if the reliability of the method and 

the nature ofthe decision justifies use of the data). 

Additionally, the 1996 SDWA amendments directed EPA "to ensure that the presentation 

ofinformation [risk] effects is comprehensive, informative, and understandable." The 

Information Quality Guidelines adopted this language and directed all Agencies: 

[I]n a document made available to the public in support of a regulation [to] 

specify, to the extent practicableY 

9 See ACC principles available at: https:l/www.americanchemistry.com/Chemicai-Hazard-and-Risk-AssessmentsPrinciples/ and further details at: https:l/www.amerieanchemistry.com/Policy/Chemicai-Safety/ChemicalAssessments/Principles.pdf. 

10 See for instance chapter 7 in the 20 II NAS Review of the Environmental Protection Agency's Draft IRIS 

Assessment of Formaldehyde available at: https://www.nap.edu/catalog/13142/review-of-the-environmentalprotection-agencvs-draft-iris-assessment-of-formaldehyde. 

11 The Information Quality Guidelines are available at: https://georgewbushwhitehouse.archives.gov lorn b/mcmorandalfy2007/m07 -24.pdf. 12 Bracketed language reflects changes to text for clarity. 

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(i) each population addressed by any estimate [of applicable risk 

effects]; 

(ii) the expected risk or central estimate of risk for the specific 

populations [affected]; 

(iii) each appropriate upper-bound or lower-bound estimate of risk; 

(iv) each significant uncertainty identified in the process of the 

assessment of [risk] effects and the studies that would assist in 

resolving the uncertainty; and 

( v) peer-reviewed studies known to the [agency] that support, are 

directly relevant to, or fail to support any estimate of [risk] effects 

and the methodology used to reconcile inconsistencies in the 

scientific data. 

b. Memorandum on Updated Principles for Risk Analysis 

In 2007, OMB and the Office of Science and Technology Policy (OSTP) issued a joint 

memorandum to Executive Departments and Agencies on Updated Principles for Risk 

Analysis (Principles for Risk Analysis ).13 This memorandum was intended to reinforce 

the principles developed in 1995. While the focus was on actions directed at improving 

public health, safety, and the environment, it was noted that many of the principles were 

relevant to other fields, such as financial or information technology risk analyses. 

The Principles for Risk Analysis reiterated the requirements for best available science as 

they were articulated in the Information Quality Guidelines and presented further 

important information regarding the use of and presentation of assumptions, judgments, 

and uncertainties in risk analyses. For instance, among other requirements, the Principles 

for Risk Analysis require that: 

Judgments used in developing a risk assessment, such as assumptions, defaults, 

and uncertainties, should be stated explicitly. The rationale for these judgments 

and their influence on the risk assessment should be articulated. 14 

Results based on different effects and/or different studies should be presented to 

convey how the choice of effect and/or study influences the analysis. The 

presentation of information regarding different scientifically plausible endpoints 

should allow for a robust discussion of the available data, associated uncertainties, 

and underlying science.15 

Due to the inherent uncertainties associated with estimates of risk, presentation of 

a single estimate may be misleading and provide a false sense of precision. Expert 

panels agree that when a quantitative characterization of risk is provided, a range 

of plausible risk estimates should be provided. 16 

13 See: https://georgewbush-whitehouse.archives.gov/omblmemoranda/fy2007/m07-24.pdf. 14 Ibid, at page 8. 15 Ibid, at page 8. 16 Ibid, at page 6. 

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c. Non-Governmental Reports on Improving Science in Regulations 

Improving Peer Review: 

In addition to government guidance, other consensus groups have spoken to the needs for 

ensuring high quality science. For instance, in 2009 the Bipartisan Policy Center put out a 

report entitled "Improving the Use of Science in Regulatory Policy."17 Important 

recommendations in this report included: 

The Administration needs to promulgate guidelines (through executive orders or 

other instruments) to ensure that when federal agencies are developing regulatory 

policies, they explicitly differentiate, to the extent possible, between questions 

that involve scientific judgments and questions that involve judgments about 

economics, ethics and other matters of policy .

18 

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. 19 

In 2012, the Keystone Center released a report entitled "Improving the Use of Science in 

Regulatory Decision-Making. "20 This report stressed the importance of consistency and 

transparency in selecting peer review panels and also noted that the regulatory process is 

better when there is a consistent, transparent and systematic review and evaluation of the 

scientific literature. 

The importance of a robust peer review process cannot be underestimated. Peer review is 

essential in the evaluation of scientific information to ensure the development of 

scientifically defensible assessments. It allows for the review of the underlying 

assumptions, methodology, criteria, and conclusions reached in the evaluation. Federal 

Agencies have several mechanisms available to them to conduct peer review of scientific 

information; however, these peer review processes and approaches are inconsistently 

applied, including the selection of peer review panel members and the consideration 

given to public and peer review comments. 

For example, during some EPA peer review meetings, the peer reviewers have appeared 

to be overly deferential to EPA and reluctant to be seen as criticizing EPA staff. We have 

also seen situations where peer reviewers have suggested discounting a study solely 

based on the funding source, without any consideration of the quality of the study. Also, 

EPA staff often comment throughout peer review meetings, essentially participating as 

peers, while stakeholders, including industry experts, are typically excluded from the 

17 See: http://cdn.bipartisanpolicy.org/wp-content/uploads/sites/default/files/BPC%20Science%20Report%20ful.pdf. 18 Ibid, at page 4. 19 Ibid, at page 45. 20 See: https://www.keystone.org/wo-content/uploads/2 0 15/081091812-Research-lntegritv-Roundtable-Report.odf. 

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dialogue. This practice undermines the integrity of the reviewers' role as independent and 

external to the assessment itself. 

Additionally, a critical element of peer review is the consideration of public comments. 

The public plays an important role in the review process by helping identify key scientific 

information and potential concerns with the assessment being evaluated. Unfortunately, 

within some Agencies, there is no robust consideration of public comments in the peer 

review process. For example, reviewers on the EPA Science Advisory Board (SAB) are 

not given clear advice regarding what it means to "consider" public comments. In fact we 

have seen SAB chairs ignore public input because they are not required to address it. 

When this has occurred, SAB staff have not clarified to the peer reviewers that they can 

and should respond to public input. 

Improving Systematic Review: 

The importance of systematic review in risk evaluation was mentioned in the 2012 

Keystone Center report, and emphasized in a 2014 NAS report ofits Review ofEPA's 

Integrated Risk Information System (IRIS) Process.21 This NAS panel noted that the use 

of systematic review approaches would "substantially strengthen" the IRIS process at 

EPA. Unfortunately, we have yet to see the IRIS program release an assessment that is 

consistent with these NAS recommendations. 

Data Access and the Protection of Confidential Business Information: 

Both the Bipartisan Policy Center report and the Keystone Center report discuss the need 

to protect proprietary business information. The legitimate need for protection must be 

balanced against public interest in the disclosure of relevant studies and data for the 

purposes of reproducibility.22 The OMB Information Quality Guidelines recognize this 

tension and note that 

Even in a situation where the original and supporting data are protected by 

confidentiality concerns, or the analytic computer models or other research 

methods may be kept confidential to protect intellectual property, it may still be 

feasible to have the analytic results subject to the reproducibility standard. 

When it comes to environmental, health and safety information about chemicals, the 

Toxic Substances Control Act (TSCA) requires that EPA have access to that information. 

ACC member companies' current practice is to share summary results of industry studies 

with EPA or to provide raw data underlying health, safety and environmental studies with 

EPA upon request. Thus the Agency has the information it needs to ensure the safe 

regulation of chemicals, and EPA can rely on this information in its regulatory decisions. 

While any proprietary information must be protected, there are processes that exist to 

make robust study summary information available to the public in a manner that is 

sufficient to ensure public understanding of the data and address transparency demands. 

When it comes to full disclosure to the public, decisions to share raw data with nonregulatory bodies are made on a case by case basis. Companies weigh factors such as the 

21 See; http;//dels.nas.edu/Report/Review-lntegrated-Risk/18764. 22 See the Keystone Center report at page 20. 

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potential health/environmental impact of the product, the commercial value of the data, 

the age of the data, and other administrative, ethical, financial, legal, technical, and public 

health considerations. 

III. Science Standards in the 2016 Lantenberg Chemical Safety Act 

When the Lautenberg Chemical Safety for the 21'1 Century Act (LCSAf3 was passed in 2016, it 

was the first time Congress directed a Federal Agency to consider not only the best available 

science but also the weight of the scientific evidence (WoE). These scientific standards, added to 

TSCA in Section 26 of the LCSA, have a prominent role in ensuring the Act achieves the 

fundamental objective of improving public confidence in the federal regulatory system. EPA 

now has a mandate to apply high quality, reliable and relevant scientific information. 

To date, EPA appears to be interpreting these scientific standards as implying that "business as 

usual" is consistent with the standards. EPA is reluctant to explicitly incorporate the best 

available science and WoE standards into the framework rules that it is developing to implement 

the LCSA. Instead, the Agency has suggested that simple reliance on existing guidelines and 

current practices are sufficient to meet the standards in Section 26.24 This is of great concern to 

ACC. 

For example, Section 26(i) of the LCSA requires that EPA make decisions using a WoE 

approach. While a definition of WoE is not provided in the statute, the June 7 Congressional 

Record provides a definition that was entered into the record by Senator Boxer, the ranking 

minority member on the committee: 

Weight of the evidence means a systematic review method 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.25 

This definition is also consistent with the June 2015 House Report language.26 

Importantly, the definition refers to using a systematic review approach, as has been 

recommended by the Keystone Center report and the NAS in 2014. It also suggests that 

evidence be judged on its quality. 

Notably, EPA's proposed risk evaluation rule does not incorporate this definition. EPA has 

asked, however, for comment on this approach. 

23 P.L. 114-182,130 Stat. 448 (June22,2016). 24 EPA's draft framework rules for prioritization and risk evaluation can be found at: https://www.epa.gov/assessingand-managing-chemicals-under-tsca!frank -r-lautenberg -chem ical-safety-21 st-century -act-5. 25 See Senate Congressional Record, June 7, 2016 at page 83518, available at: 

https://www.congress.gov/crec/20 16/06/07/CREC-20 16-06-07-pt1-PgS3511.pdf. 26 See House Report at page 33, available at: https://www.congress.gov!ll4/crptfhrpt176/CRPT-l14hrpt176.pdt: 

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A recent example demonstrates that EPA apparently does not interpret WoE in the same way 

Congress did in the LCSA. In the draft risk assessment of l-bromopropane (released prior to 

enactment ofLCSA), EPA did not conduct a systematic review, and the draft assessment did not 

provide information regarding the quality of the individual studies.27•

28 Although the assessment 

identified some quality considerations, EPA did not provide any information regarding its own 

findings from its quality review of the individual studies.29•

30 Additionally, EPA did not describe 

how considerations were applied and what constitutes a study of"high quality" or "good 

quality." While EPA staff orally noted that they followed a WoE approach/ 1 EPA simply chose 

the value that provided the lowest point of departure and thus would be most health protective. 

The 1-bromopropane draft risk assessment is not consistent with the best available science or the 

WoE approach envisioned under the LCSA. If EPA chooses to simply follow current practices, 

the Agency will embark on a process that is not consistent with the new Section 26 science 

standards. 

Section 26 requires EPA to develop, within two years of enactment, any new policies, 

procedures and guidance that are necessary to ensure compliance with the LCSA. In addition, 

within five years of enactment and then once every five years, EPA is required to review these 

policies, procedures and guidance. This approach will ensure that EPA is consistently relying 

upon scientific approaches that are consistent with the state of the science. 

IV. Potential Solutions to Improving Agency Science 

ACC provides the following four recommendations to improve the science supporting regulatory 

decision making. 

a. Improve and Clarify Scientific Definitions 

ACC believes that the intent of Congress in drafting the scientific standards in the LCSA is clear. 

It is also clear that EPA's proposed interpretation diverges from Congressional intent in 

important respects. ClarifYing that the intent of scientific standards is to improve existing 

Agency practices would be useful. In addition, providing clear and specific definitions for terms 

like best available science and WoE would be beneficial to the consistency, reliability and 

credibility of EPA's regulatory decisions. These definitions should address not only what 

Agencies should consider when evaluating scientific information, but also what information 

27 See Comments ofthe American Chemistry Council on the TSCA Work Plan Chemical Draft Risk Assessment of 

1-Bromopropane, Docket No. EPA-HQ-OPPT-2015-0084, May 9, 2016. 28 See peer review report/meeting minutes available at: https://www.regulations.gov/document?D=EPA-HO-OPPT20 15-0805-0028, at page 41 which states: "While the Agency indicates that the literature was thoroughly reviewed 

for robustness, adequacy, etc., the Committee found that it is not clear what exact methodology was used to 

systematically rate, rank, and select studies to inform sections of the risk assessment. For example, was a 

quantitative ranking system developed for study quality?" 29 lbid. 30 See draft available at: https://www.epa.gov/sites/production/files/20 16-03/documents/1-

bp report and appendices final. pdf, at Appendix M. 31 See Chemical Safety Advisory Committee Meeting Transcript available at: 

https://www.regulations.gov/document?D=EPA-HQ-OPPT -2015-0805-0027; at page 130. 

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Agencies should present in evaluations. Requiring the Agencies to "show their work" and 

present their thought process in a transparent and clear manner would be have tremendous value. 

For example, adopting the language from the SD W A Amendments, we suggest the following 

definition of best available science: 

Best available science means information that has been evaluated based on its strengths, 

limitations and relevance and that the Agency is relying on the highest quality 

information. In evaluating best available science, the Agency will also consider the peer 

review of the science, whether the study was conducted in accordance with sound and 

objective practices, and if the data were collected by accepted methods or best available 

methods. To ensure transparency regarding best available science the Agency will 

describe and document any assumptions and methods used, and address variability, 

uncertainty, the degree of independent verification and peer review. 

Defining WoE clearly would also be advantageous. As noted previously, we suggest the 

definition articulated in the Senate debate on LCSA on June 7, 20 !6. When using this definition, 

it will also be important to clearly define the term "systematic review" as there may not be a 

uniform interpretation of that term among stakeholders. 

A particular concern in applying the best available science and weight-of-the-evidence is the 

tendency of federal agencies to use default assumptions, even when data are available. 

Despite more than 30 years of extensive mechanistic toxicological research by academia, 

research institutions and the private sector, some regulatory programs in EPA continue to rely on 

default approaches for hazard characterizations and risk assessments that date back to the 1970s. 

Even though frameworks for integrating mechanistic information and mode of action have been 

developed by authoritative bodies and incorporated into the EPA cancer risk guidelines,32 at the 

present time, there is uneven use within EPA of such approaches in hazard characterizations and 

risk assessments. EPA's Office of Pesticide Programs has often determined, based on WoE 

evaluations that include consideration of mode of action and human relevance, that carcinogenic 

effects in animal studies are not relevant to humans or the carcinogenic effects are secondary to 

target organ toxicity, and thus no carcinogenic risks are posed to humans at doses below those 

which produce such toxicities. However, the IRIS program continues to rely on the 1970s default 

linear approach for cancer risk assessment. The IRIS program steadfast reliance on default linear 

approaches has significant consequences for many chemicals and can create tremendous costs to 

address "phantom risks" in site cleanups. 33 This outdated manner in which the EPA IRIS 

program deals with mode of action knowledge does not comport with use of best available 

science. 

Therefore, in implementing the definitions of best available science and WoE for the evaluation 

of the potential carcinogenic effects of substances, when supported by the scientific data, EPA 

should present non-linear modeling approaches consistent with the available data and scientific 

understanding of endogenous exposures and mode of action, in lieu of, or at a minimum in 

addition to, a linear default. Further, such assessments should include, in addition to upper 

32 See EPA 2005 Guidelines for Carcinogen Risk Assessment 

"See George M. Gray and Joshua T. Cohen Nature 489, 27-28, 06 September 2012. 

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bound calculations, the distribution of estimated hazards or risks, including central tendency 

values, and clear criteria for when defaults are justified, including criteria for the application of 

uncertainty factors. 

b. Improve Oversight and Develop Quality Checklists 

Considering the guidance that already exists from OMB, other consensus bodies, and within the 

Agencies, stronger oversight to ensure that Agencies are following existing guidance could be 

highly effective. This oversight could come from independent offices within Agencies, Congress, 

or OMB or OSTP within the Executive Office of the President. One tool that may be effective is 

to develop a checklist to ensure that quality standards are met in scientific evaluations that 

support regulations. For instance, a recent publication from former EPA scientists has suggested 

that to promote transparency and consistency, risk evaluations could be compared to a guide or 

checklist which depicts all the important elements of a high quality assessment. 34 Drs. Dellarco 

and Fenner-Crisp suggest that this guide "could be used by authors, sponsors, risk assessors, peer 

reviewers, and other interested stakeholders to determine if an assessment meets the current best 

scientific practices."35 

c. Improve Peer Review Practices 

As noted earlier, the importance of a robust peer review process cannot be underestimated. 

Ensuring that peer review panels are composed of a diverse group of experts that have the 

breadth and depth of experience necessary to review scientific analyses in a transparent and 

comprehensive manner would be beneficial. It is also important to ensure that peer reviewers are 

fully independent from the program office issuing the assessment and conflicts of interest are 

fully evaluated and disclosed. More details on improving peer review can be found in the OMB 

Information Quality Bulletin for Peer Review,36 as well as in reports from other consensus 

bodies, as discussed in Section II. 

d. Change Publication Incentives and Standards for Scientific Grants and 

Funding 

Much has been written about the lack of reproducibility of research findings published in peer 

reviewedjournals.37 The trend towards "publish or perish" puts immense pressure on 

researchers to publish findings, and in particular to publish predominantly positive findings. 38 

Publication bias is common to published academic literature. This leads to bodies ofliterature in 

which the majority of publications support a given hypothesis. Publication bias stems from the 

fact there are many fewer incentives for publishing negative information or information that does 

34 See publication available at: https://ehp.niehs.nih. gov/15-1 0483/. 35 Ibid 36 See: https://www.gpo.gov/fdsys/pkg/FR-2005-0 l-l4/pdf/05-769.pdf. 37 See for example: http://joumals.plos.org/plosmedicine/article?id-l 0.137lljournal.pmed.0020 124, or 

http://www.nature.com/news/reproducibility-1.17552. 

38 See for example: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3999612/. 

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not support a hypothesis. Promotions and job security in academia, as well as having grants 

funded by Federal Agencies, are often tied to an author's publication record. 

Government Agencies can play an important role by 1) changing the incentives for grant funding 

such that decisions to fund research do not depend so heavily upon finding positive results and 2) 

putting in place standards to ensure that research studies are designed in a manner that will make 

them useable for regulatory decision making. Standards for funding could ensure that research 

studies follow best scientific practices and are designed with regulatory use in mind. For 

instance, for chemical risk assessment, studies should be designed to test more than three doses 

such that a dose-response analysis can be conducted. Unfortunately we have seen too many 

examples of government funded research where only one high dose is tested. While this 

information may have some value, it is then difficult to use these data to determine what impact 

the same chemical may have at more environmentally relevant lower dose ranges. If the 

government demanded a more robust study design when approving the research projects, the data 

obtained would likely be much more useful. 

V. Conclusion 

Ensuring that Federal decision making is firmly based on the use of high quality science is 

critical to helping the government meet its obligation to protect human health and the 

environment. This can be achieved through common sense reforms that will lead to more 

efficient and effective regulatory decisions. ACC looks forward to working with members of the 

Committee to enhance approaches to ensure that high quality science is the foundation to 

regulatory decision making. 

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Appendix 1: Examples of Scientific Concerns with Federal Science Evaluations 

Below ACC provides a few specific examples where Federal Agencies have fallen short when it 

comes to using the best available science. 

a. Case 1: OSHA Crystalline Silica PEL 

Background 

OSHA finalized its workplace Permissible Exposure Limit (PEL) for crystalline silica in March, 

2016. The final PEL reduced the standard from 100 J.!g/m3 to 50 J.!glm3

. 

Crystalline silica (commonly encountered as beach sand) is the second most abundant mineral in 

the Earth's crust. It is ubiquitous in rocks, gravel, sand and soils; plays a crucial role in 

construction and transportation; and is essential for many manufacturing processes and countless 

products. For example, it is a critical material for foundries and steel making, and is a key 

component of abrasives, paints, high-tech equipment, glass and ceramics. 

OSHA contended that the PEL of 100 J.!g/m3 was not sufficiently protective. In fact, however, the 

data clearly shows that the incidence and rate of silicosis mortality have declined dramatically 

since adoption of the 100 J.!g/m3 PEL in 1971, and the remaining cases can be attributed to higher 

silica exposures that were prevalent decades ago (allowing for latency) and to exceedances ofthe 

100 J.!g/m3 PEL. Moreover, the best evidence indicates that for silicosis and other potential 

pulmonary diseases, including lung cancer, there is a concentration-based threshold for silica 

exposure that exceeds 1 00 J.!glm3• 

Importance 

The new PEL is not economically feasible across multiple sectors of general industry and 

therefore will cause significant economic disruption throughout the economy. OSHA estimated 

that the annualized costs for all of general industry to comply with the revised standard would be 

$359 million. That estimate of compliance costs is deeply flawed and vastly understates the true 

costs of compliance, which are likely to be more than an order of magnitude higher. It would be 

far more cost-efficient and effective to bring all general industry employers into compliance with 

the longstanding PEL of 100 ).tg/m3 rather than mandating that they attempt to comply with the 

new PEL of 50 ).tg/m3

• 

Scientific Concerns 

Because of its long latency period, silicosis cases seen today are attributable largely to exposures 

that occurred decades ago- in most cases, to exposures that began before OSHA's long-standing 

PEL of 100 J.tg/m3 was even adopted. OSHA's argument that silicosis cases are underreported 

does not alter the fact that silicosis cases have dropped dramatically in the previous 40+ years, as 

silicosis cases have been underreported relatively consistently through that same time period. 

There are fundamental shortcomings and limitations in OSHA's risk assessment for all of 

OSHA's identified endpoints of concern: 

o Important statistical errors in modeling and inference, including in particular a failure 

to adequately control for biases, which can lead to false positive results. 

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o A failure to properly model exposure measurement errors, which are common in the 

silica worker cohort studies in particular. 

o Generally, uncertainties are not well characterized in the preliminary quantitative risk 

assessment. 

o A failure by OSHA to carry out any causal modeling or analysis that would allow it to 

conclude that a reduction in the PEL would actually reduce adverse health effects. 

The alleged association between silica exposure per se and lung cancer remains controversial in 

the scientific community. OSHA did not properly weigh and consider the totality of the 

epidemiological evidence, discounting the significance of negative studies while choosing to 

highlight those studies that would confirm OSHA's position. Furthermore, as noted above, the 

best evidence points to an exposure concentration threshold for potential silica-related lung 

cancer that exceeds the PEL of 100 Jlg/m3 that applied in general industry before the new rule 

was adopted in 2016. 

b. Case 2: EPA IRIS Assessment of Trimethylbenzenes (TMB) 

Background 

On September 9, 2016, EPA issued its final report on the IRIS assessment ofTrimethylbenzenes 

(TMBs), which addresses the potential non-cancer and cancer human health effects from longterm exposure to TMBs. Humans are not exposed to individual TMB compounds, but to complex 

mixtures. According to EPA, the primary uses for TMBs are as a blending agent in gasoline 

formulations (C9 aromatic fraction); solvents; and as a paint thinner. 

In its review ofTMBs, the EPA fell far short in meeting its obligations to improve its IRIS 

processes and assessment reports. Without explanation, EPA failed to respond to public 

comments on the draft TMBs assessment, even though the IRIS process for developing 

assessments explicitly includes a response to comments element. 

Importance 

As a final report, the IRIS assessment on TMBs will inform risk management decisions on 

TMBs by EPA's program and regional offices. 

Scientific Concerns 

The IRIS assessment ofTMBs does not accurately represent the health effects associated with 

exposure to TMBs because EPA failed to utilize a consistent and transparent data evaluation 

procedure for evaluating and weighing the full body of evidence. 

In particular, EPA failed to rely on available guideline studies on commercial complex C9 

aromatic mixtures that industry conducted under EPA's TSCA program. The entire commercial 

C9 aromatic blend, which contains a high percentage ofTMBs, has similar toxicological 

properties and health effects as the individual isomers ofTMB. Thus, guideline studies on the 

commercial complex of aromatic mixtures are highly relevant to assessing the toxicology of 

TMBs. 

EPA's Office of Pesticide Programs (OPP) has also reviewed the toxicology ofTMBs and 

determined that the health effects ofTMBs can be efficiently assessed by relying on C9 aromatic 

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mixture studies. OPP reached different scientific conclusions, including different quantitative 

health effect numbers, than that of EPA's IRIS Program. EPA, however, did not resolve these 

differences during the IRIS assessment ofTMBs. 

c. Case 3: NIOSH Cancer Policy 

Background . . In the NIOSH Carcinogen Policy, released in December 2016, NIOSH states that underlymg th1s 

entire policy is the "recognition that there is no known safe level of exposure to a carcinogen."39 

ACC believes this statement is based on a default assumption and not clear scientific evidence, 

as certain carcinogens have thresholds or doses below which no adverse effects are 

identified.40.41 Assuming that every chemical is toxic at high exposures and linear at low 

exposures does not comport with modem-day scientific knowledge of biology and there is no 

compelling evidence-based justification for a general low-exposure linearity. Instead, casespecific mechanistic arguments are needed.42 

d. Case 4: EPA IRIS Assessment of Ethylene Oxide (EO) 

Background 

EPA posted the final IRIS Assessment of EO in December 2016. EPA, using unsupportable, 

conservative, risk assessment modeling, concluded that the one-in-a-million lifetime cancer risk 

associated with exposure to EO is far below EO background levels currently in the environment 

and EO levels naturally converted from ethylene in humans through breathing. 

This conclusion is not plausible, and not scientifically supportable. It is based on an inadequate 

evaluation of a body of evidence from human studies that include historical exposure levels to 

39 See NIOSH Carcinogen Policy available at: https://www.cdc.gov/niosh/docs/2017-IOO/default.html. 40 See, for example Olden K, Vulimiri SV. 2014. Laboratory to community: chemoprevention is the answer. Cancer 

Prev Res (Phil a). 7(7):648-52. http://cancemreventionrescarch.aacrjournals.org/content/canprevres/7/7/648.full.pdf 

at 650; which states: "Our understanding oftoxicologic mechanisms has advanced considerably since the linear nonthreshold model was adapted for cancer risk assessment. Knowledge of mechanism of action is critical for informing 

dose-response relationship below the experimental observable range. Johnson and colleagues (I) have used new 

technologies in analytical chemistry and molecular biology to characterize downstream biologic events in the 

exposure disease continuum. They showed that AFB 1 is a classic genotoxic substance in that it binds covalently to 

DNA and induces mutations. In fact, DNA adduct formation exhibits a characteristic linear dose-response curve 

over a wide range. But, further analysis demonstrated a threshold mode of action, with respect to internal dose of 

active metabolite and hepatocarcinogenesis. That is, there was substantial adduct formation and DNA damage 

without having any affect [sic] on development of hepatocellular carcinoma." 41 See, for example: United States Environmental Protection Agency (EPA). 2015. Chemicals evaluated for 

carcinogenic potential office of pesticide programs, annual cancer report. Washington, DC. 

http://npic.orst.edu/chemicals evaluated.pdf. EPA has determined that a number of substances that produce cancer 

at high doses are not likely to be carcinogenic to humans at low doses. 42 Rhomberg LR. Goodman JE, HaberL T, Dourson M, Andersen ME, Klaunig JE, Meek B, Price PS, McClellan 

RO, Cohen SM. 2011. Linear low-dose extrapolation for noncancer health effects is the exception, not the rule. Crit 

Rev Toxicol. 41 (1):1-19. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3 038594/pdf/btxc 12-00I.pdfand Bogen, 

KT. 2016. Linear-No-Threshold Default Assumptions for Noncancer and Nongenotoxic Cancer Risks: A 

Mathematical and Biological Critique. Risk Analysis Risk Analysis, Vol. 36, No.3. 

http://onlinelibrary.wiley.com/doi/10.1111/risa.12460/pdf .. 

15 I Page 
71 

EO that are far higher than current occupational exposure limits. Other, more accurate, data 

sources are available, and alternative scientific risk assessment modeling approaches could have 

been used, but EPA made no serious, systematic attempt to integrate all of the evidence. 

Importance 

A determination by EPA that EO, with a myriad of important applications including the 

sterilization of medical equipment for surgery, can cause cancer at less than one part-pertrillion43 exposure will needlessly cause alarm and confusion, not only among workers, but also 

in the general population and in the public health and medical communities. These numbers are 

not reliably measurable, and are orders of magnitude below current endogenous and exogenous 

levels of EO. 

Scientific Concerns 

EPA did not adequately consider study quality into the IRIS review. Industry cohorts were not 

considered with the other epidemiology data sets even though this cohort was stronger than 

foreign cohorts used that contained occupational exposure interferences. 

EPA did not fully utilize linear and non-linear modeling approaches (as allowed within the 

cancer assessment guidance) to estimate cancer risk from current EO exposure levels and 

expected DNA repair mechanisms. 

EPA did not consider realistic exposure scenarios and fully delineate endogenous vs. exogenous 

EO and associated health impacts. 

In 2007, EPA's SAB identified problems with the linear regression modeling and low dose 

extrapolation for determining cancer risk. The SAB concluded that substantial revisions were 

needed in the IRIS assessment including: 

• Acquiring and using individual data for modeling rather than grouping populations for 

modeling that currently results in overly conservative estimated cancer risks; 

• Given the distribution of and questionable association with certain cancer types, 

considering using both linear and non-linear approaches to estimate cancer risk; 

• Providing more transparency and correcting flaws associated with inappropriately 

grouping lymphohematopoietic (LH) cancers and combining genders for the doseresponse analysis. 

In 2015, a specially selected SAB Committee reviewed a revised draft EO IRIS assessment. The 

committee, however, did not conduct an independent, unbiased review. Problems included: 

• Inaccurate public statements by several SAB members indicating industry produced 

scientific studies should be disqualified due to potential industry influence, and the 

acceptance by SAB and IRIS staff of such a position; no evidence of biased data 

sponsored by industry was ever presented, and it is clear that those members advocating 

this position should have been disqualified due to these clear biased positions. 

43 1 part per trillion is roughly equivalent to 1 second in 320 centuries or 1 inch in 16,000,000 miles 

16 I Page 
72 

• Lack of understanding by SAB members of new evidence-based medicine concepts 

regarding mutagenicity of cancer cells and the contribution of naturally occurring EO in 

DNA repair mechanisms; 

• Recommendation of epidemiology data sets with questionable or scientifically unsound 

characteristics to estimate cancer risk and rejection of alternative data sets that are as or 

more robust than those selected; 

• EPA still did not use individual data for modeling as recommended in 2007, and did not 

seriously explore alternatives to the linear low dose modeling approach. 

Even though the SAB made extensive recommendations in its 2015 report and public comments 

were submitted on the IRIS draft reviewed by the SAB, EPA still did not respond fully to all 

comments submitted or implement all the changes recommended by the SAB. 

e. Case 5: National Ambient Air Quality Standard for Ground-Level Ozone 

Background 

In 2015, EPA lowered the National Ambient Air Quality Standard (NAAQS) for Ground-Level 

Ozone from 75 ppb to 70 ppb. Ozone, which is one of six criteria pollutants regulated under 

Section 109 of the Clean Air Act, is formed from a reaction between nitrogen oxide (NOx), 

volatile organic compounds (VOCs), and sunlight. Exposure to relatively high concentrations of 

ozone can cause adverse respiratory effects and interfere with plants' ability to produce and store 

food. 

In 2008, the ozone NAAQS was set at 75 ppb. Areas were not designated as complying or failing 

to comply with this standard until May 2012 due to unnecessary delays following the Obama 

Administration's premature reconsideration of the standard in 2010. This resulted in areas across 

the country not being allowed sufficient time to begin implementing the 2008 standard before 

EPA changed the standard again, which the Agency justified as being necessary to protect public 

health and welfare. However, a closer look at EPA's work during this most recent review process 

questions the need to revise down the standard. 

Scientific Concerns 

EPA relied on ecological epidemiology studies, also known as time-series analyses and clinical 

studies, as the basis to lower the ozone NAAQS to 70 ppb in 2015. However, EPA failed to 

adequately characterize the uncertainties associated with adverse health effects reported in these 

studies. Ecological epidemiology studies are not scientifically rigorous enough and are not 

designed to determine if ozone was responsible for the demonstrated the health effects. Clinical 

studies are limited by the small sample sizes and because they do not adequately consider the 

normal variation in the lung function. 

For example, in the 2015 standard, EPA relied on two new studies, Schelegle et al. (2009) 44 and 

Kim eta!. (2011).45 These studies both used a small sample which, while not unusual for a 

44 Schelegle, ES; Morales, CA; Walby, WF; Marion, S; Allen, RP. 2009. 6.6-Hour inhalation of ozone 

concentrations from 60 to 87 parts per billion in healthy humans. Am. J. Respir. Crit. Care Med. 180(3):265-272. 45 Kim, CS; Alexis, NE; Rappold, AG; Kehrl, H; Hazucha, MJ; Lay, JC; Schmitt, MT; Case, M; Devlin, RB; Peden, 

DB; Diaz-Sanchez, D. 20 II. Lung function and inflammatory responses in healthy young adults exposed to 0.06 

ppm ozone for6.6 hours. Am. J. Respir. Crit. Care Med. 183:1215-1221. 

17 I Page 
73 

controlled human exposure study, proves difficult as a basis for drawing broader conclusions 

with regard to the protection of public health. EPA identified lung function decrements of only 

2.8% to be adverse effects when the variation of lung function in normal subjects can vary by 

over 5% (Pellegrino et al. 2005)46 to 17.6% (Medarov et al. 2008).47 EPA must rely on 

biological, not just statistical, significance in identifYing an adverse health and provide clear 

guidance on how to define adverse effects. 

Ultimately, these studies did not actually support health effects below the 75 ppb standard, and 

EPA primarily justified the regulation impacting 300 million people on study results from just a 

few individuals. 

46 Pelligrino, R; Viegi, G; Brusasco, V; Crapo, RO; Burgos, F; Casaburi, R; Coates, A; van der Grinten, CPM; 

Gustafsson, P; Hankinson, J; Jensen, R; Johnson, DC; Macintyre, N; McKay, R; Miller, MR; Navajas, D; Pedersen, 

OF; Wanger, J. 2005. Interpretive strategies for lung function tests. Eur. Respir J. 26: 948-968. 47 Medarov Bl, Pavlov VA, RossoffL. 2008. Diurnal variations in human pulmonary function. lnt J Clin Exp Med. 

1{3):267-273. 

lSI Page 
74 

The EPA's Science Office Removed "Science" 

From Its Mission Statement 

BY EMILY ATKIN 

March 7, 2017 

When President Donald Trump took office in late January, his administration began 

tweaking the language on government websites. Some of the more prominent changes 

occurred on Environmental Protection Agency pages-a mention of human-caused 

climate change was deleted, as was a description of international climate talks. The 

shifts were small, but meaningful; many said they signaled a new era for the EPA, one in 

which the agency would shy away from directly linking carbon emissions to global 

warming and strive to push Trump's "America First" message. 

Those initial tweaks were documented by the Environmental Data and Governance 

Initiative, a group of scientists and academics who spend their free time tracking 

changes to about 25,000 federal government webpages. On Tuesday, they shared their 

latest finding with the New Republic: The EPA's Office of Science and Technology Policy 

no longer lists "science" in the paragraph describing what it does. 
75 

"This is probably the most important thing we've found so far," said Gretchen Gehrke, 

who works on EDGI's website tracking team. "The language changes here are not 

nuanced-they have really important regulatory implications." 

The EPA's Office of Science and Technology has historically been in of 

developing clean water standards for states. Before January 30 of this year, the website 

said those standards were "science-based," meaning they were based on what peerreviewed science recommended as safe levels of pollutants for drinking, swimming, or 

fishing. Since January 30, though, the reference to "science-based" standards 

has disappeared. Now, the office, instead, says it develops "economically 

and technologically achievable standards" to address water DV.tlwtwltl. 

Screenshot courtesy of EDGI 

Gehrke said she thinks these changes 

should be regulated. Environmentalists often argue for performance-based regulations, 

where air and water is required to meet a certain standard of quality, no matter how 

companies choose to meet that standard. Gehrke says removing "science" from OST's 

missions and replacing it with "technologically achievable" means the EPA is moving 

toward more technology-based standards, where polluters just have to install certain 

types of technology. 

Some worry these changes signal the EPA's new direction-one that prioritizes business 

interests over public health and science-under new Administrator Scott Pruitt, who 

has close ties to fossil-fuel companies. Pruitt didn't mention public health once in 

his first speech to agency employees, instead focusing on improving the EPA's 

relationship with private interests. In a tweet after his speech, Pruitt said he was 
76 

committed to working with several types of "stakeholders" on environmental 

stewardship. He did not mention environmentalists as one of those stakeholders. 

~~ Administrator Pruitt 

I'm dedicated to working w/stakeholders -

industry, farmers, ranchers, business ownerson traditional values of environmental 

stewardship. 

The Union of Concerned Scientists {UCS), a science advocacy organization, shares 

EDGI's concerns. "The role of the EPA is to protect public health and safety," said 

Andrew Rosenberg, Director of UCS's Center for Science and Democracy. "So what you 

want a science office to do is make sure you're using the best science available, and 

what's safe for the public. That's a pretty critical role." 

Rosenberg said it would be a "major change in direction" if the EPA stopped prioritizing 

the best science and focused instead on what's most "economically achievable" for 

businesses. "I think we have to be very mindful," he said. "It seems like this EPA and 

this administration broadly seem to view their job as being a support for business as 

opposed to safeguarding public health." 

The EPA did not return our request for comment. 

Emily Atkin is a staff writer at the New Republic. ('t'ernorwce 
77 

Post-Hearing Questions for the Record 

Responses of Professor Susan Dudley, 

Director, George Washington University Regulatory Studies Center 

From Ranking Member Heidi Heitkamp 

United States Senate, Subcommittee on Regulatory Affairs and Federal Management 

Committee on Homeland Security and Governmental Affairs 

"Agency Use of Science in the Rulemaking Process: 

Proposals for Improving Transparency and Accountability" 

March 9, 2017 

1. You state in your testimony that "Congress should not delegate decisions to agencies on the 

pretense that science alone can make the normative determination of what policy ought to 

be." 

• In that vein, is codification of the EO 128661anguage on "best reasonably obtainable" 

science a mistake? What obvious traps should Congress avoid? 

[think the language in EO 12866 Section l.b.7. \\hich states "Each agency shall base its 

decisions on the best reasonably obtainable scientific. technical, economic, and other int(Jrmation 

concerning the need for. and consequences of~ the intended regulation,'' is sound guidance. It 

recognizes that good regulatory decisions require agencies to assess the need f()r and 

consequcnccs of actions. and depend on different types of information- scientific as well as 

technical. economic. and other. 

In delegating rcgulntory authority, legislative language should not direct agencies to base 

decisions on science without recognizing that other factors are also important in determining 

optimal solutions. (My answer to question 7 elaborates on this.) 

2. The explanation in your written testimony about the two main ways science is politicized is 

very instructive. 

• Have there been any empirical studies about the incidence of normative versus conflated 

science? In your experience, is one more prevalent than the other? 

I am not aware of empirical studies. and I'm not sure how one would go about measuring this 

phenomenon in an empirical way, but this is a very interesting question. Many criticisms of 

advocacy science come from industry. but one former EPA scientist. Robert Lackey. now 

professor emeritus at Oregon State University has spoken compellingly on ''hat he calls 

"normative science." Here arc 1 short pieces: 

lillD/! I\\ ,QJ:ci!On'llgtc.cd u1s' stem/ li Jcstu29 3 7/2004c'~·"o20-% )()Nonnati vc%2 OSci cnce'%20-

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The George Washington University Regulatory Studies Center 
78 

My working paper provides quotations fi·mn former EPA Clean Air Scientific Advisory 

Committee members who raise similar concerns. 

3. Your testimony explains how policymakers and the public may be unaware how 

deliberations beget false or misleading statements of certainty. Experience suggests that 

these discussions are then subsequently further simplified by news media and interest groups. 

• Do you have any ideas for increasing scientific and policy-making literacy among a 

diverse electorate and population? 

Greater transparency in the models. assumptions. and risk assessment policy choices could 

inform the public and policy makers and encourage more open. constructive debate on those 

choices. One way to make risk assessment policy choices more transparent to the public as well 

as decision makers would he for agency scientists to calculate and present multiple risk estimates 

based on a variety of scientitlcally plausible data sets. endpoints, models. etc. (This is something 

GW Public Health professor George Gray & I suggested in a chapter of a 20!2 book. Institutions 

and Incentives in Regulatory Science. Lexington Books, edited by Jason Johnston. I am trying to 

get the Subcommittee a copy of that volume. which has other articles you may find relevant.) 

Once a range of plausible risk outcomes is identified based on different scicntitically plausible 

inputs. agencies could transparently identify which set of inputs. models, and outcomes 

comported with their preferred risk assessment policy choice. Policy ollicials would choose 

specific numerical values !l·om a range of scientifically plausible risk estimates and publicly 

defend the policy choices that support that choice. This would not only provide the public 

information on the range or risks that scientifically defensible inputs predict, but it would 

provide policy officials a serious incentive to look into estimates of risk, consult with a broad 

vmiety of experts to understand the range of scientific views, and explicitly articulate the policy 

preferences informing their decisions. 

Legislation you have introduced that requires advanced notices of proposed rulemaking could 

encourage pre-rulemaking disclosure of risk assessment inf(l!'mation. to engage broad public 

comment on the proper choice of studies. models, assumptions, etc. long bct(>re any policy 

decisions are fi·arned. and "positions" established. Your hill requiring "prospective-retrospective" 

analysis could also provide the public valuable int(mnation on which key assumptions will 

bcncfit lrom follow up analysis and feedback. 

4. If one accepts the premise that key stakeholders too often dominate public comment periods 

and highly complex scientific deliberations in rulemaking, this begs the question about 

outcomes. 

• Is there academic literature exploring whether this dynamic brings about balanced and 

fairly compromised outcomes? 

I've spoken with colleagues who know this literature better than I. They say there is mixed 

evidence regarding whether comments matter (some studies find they matter. others less so). 

There is some evidence that business/industry comments matter more than others (e.g .. when 

The George Washington University Regulatory Studies Center 2 
79 

industry is in agreement. industry comments matter), though that may reflect the kvcl of detail 

and analysis provided by industry compared to other commenters. 

A 2012 Keystone Center report oiTcrs a series of recommendations on ··the composition of 

committees that are empaneled to review the science behind a regulatory decision" that may be 

relevant to this question. (https://www.kcystone.orgiimagcs/kcvstone-center/spp 

ilil<:ltJll.\?ILts/f !calth/R~~lJ.l:_\:h_%2()Jt:ll\:gritv'\:QlQl{Q!J.!)1£blc'X,20Rcportllilf) Acknowledging the 

importance of choosing panelists that '"have the knowledge, training, and experience needed.'' it 

admonished agencies "to recognize that all potential panelists will have conscious and 

unconscious biases," and said that "the panel selection process requires review of the disclosed 

inl(mnation and a judgment as to the ability of each prospective panelist to participate in open 

discussion and to consider other perspectives ... It encourages a range of perspectives, 

background, and opinion. 

• Alternatively, are you aware of any empirical evidence that greater involvement by 

average Americans will result in different outcomes? 

According to my colleagues. when average Americans get involved, they tend to do so via mass 

comment campaigns that are started by interest groups. Such comments don't add much, if any, 

legal/technical value, but can signa! political problems (i.e., there is a big constituency out there 

that cares in a particular way. an awareness that could affect an agency that is worried about 

congressional oversight). There are case studies of specific rulemakings where mass comment 

campaigns apparently aCfected the content of the rule. (They mentioned USDA's organic 

rulemaking from years ago). 

Cornell's Regulation Room is an interesting efli.Jrt to engage average Americans in rulemaking. 

http://rcgulationroom.org/ 

5. There is a continuing increase in the number of claims deeming data and science provided by 

industry and used by agencies in mlemaking, to be Confidential Business Information (CBI) 

or proprietary. This of course prevents agencies from publicly disclosing such information in 

conflict with everyone's stated desire for greater transparency. 

Should we require that each new and existing CBI claim be fully justified by its ownerthat is make them explain how and why disclosure would do irreparable harm? 

• How do we get around the need for agencies to access information and science from 

industry that businesses legitimately don't want to provide to competitors? 

f don't have enough expe1iise in CBJ to be very helpful here. One concern may relate to the 

purpose of the requests. as agencies sometimes seck detailed operating inf(Jrmation in order to 

write more prescriptive regulations, rather than to set performance-based standards (as 

encouraged by FOs 12866 and 13563 ). 

6. The issue of regulatory resources is very important to me. Imposing new administrative 

rulemaking procedures often triggers demands for additional agency or OIRA resources. 

Where science is concerned, it becomes even more complex. For example, some agencies 

neither sponsor or directly conduct scientific investigation but rather outsource research by 

The George Washington University Regulatory Studies Center 
80 

necessity and depend heavily upon external entities to provide information needed to inform 

rulemaking. 

• In your view, what resources are most important (i.e. tunding, personnel, other)? 

Parkinson's Law -that work expands to Jill the time availahle for its completion may be 

insightful here. Perhaps setting better priorities could help agencies focus existing resources in 

areas where I) public problems demand a government solution because they cannot be addressed 

through private action. and 2) additional scientific research could reduce key uncertainties and 

improve regulatory decisions (the value of information or VOl concept 

!:ll.trl.Jiess\\ron'!.com/lw185x'\aluc of infi.>rmation fi>lll. examples/). Also. soliciting input 

earlier in the regulatory process (e.g., through advanced notices of proposed rulemaking) could 

leverage expertise fi·mn a variety of sources. 

7. Your testimony includes an explanation that "The Clean Air Act directs EPA to set National 

Ambient Air Quality Standards (NAAQS) to "protect public health" with an "adequate 

margin of safety," but the agency falls prey to the science charade. 

• Is the problem here in part one of Congressional excess in statutory drafting? Would 

anything be different if Congress mandated that EPA merely "promote" instead of 

protecting public health? 

I think the prohlcm is that the language, as interpreted by EPA and the Supreme Comi. docs not 

recognize that considerations other than the health effects of exposure are relevant to the 

decision. If the legislative standard vvcre conceptually to separate risk assessment from risk 

management. discussions over the proper standard would be more transparent. To do that, the 

legislation would direct agencies first to assess risks under di!lercnt scenarios and then to choose 

a level appropriate to protect public health. taking into account a) the risk reduction achievable 

ti·om reductions (from the risk assessment step), hut also b) the associated bcnclits, c) the 

feasibility of controls, and d) the costs of achieving the standard. 

Some statutes directed at health, safetv and environmental risks have facilitated more rational 

regulatory policy than others by recognizing that risk management requires nonnative judgments 

that consider tradeoffs. For example, the Safe Drinking Water Act requires EPA to consider the 

costs as well as the benefits of requiring local water authorities to install controls for specific 

substances. Perhaps that is one reason why the debates over drinking water standards are 

generally less acrimonious than debates over ambient air quality standards. Since the statute 

allows explicit consideration of tradeoff's when setting standards, the full burden of decisionmaking is not vested in the risk assessment. As a result, policy makers and interested parties may 

have less incentive to embed policy preferences in the risk assessment portion of the analysis, 

hecause they can debate them openly and transparently in the risk management discussion. 

Codifying current executive requirements for performing regulatory impact analyses, including 

benctit-cost analyses. could provide a "supcrmandate" that would require agencies to explicitly 

present uncertainties and tradeolfs and to justify decisions in a transparent manner. 

The George Washington University Regulatory Studies Center 4 
81 

Post-Hearing Questions for the Record 

Submitted to Andrew Rosenberg, Ph.D., Director, Center for Science and Democracy, 

Union of Concerned Scientists 

From Ranking Member Heidi Heitkamp 

United States Senate, Subcommittee on Regulatory Affairs and Federal Management 

Committee on Homeland Security and Governmental Affairs 

"Agency Use of Science in the Rulemaking Process: 

Proposals for Improving Transparency and Accountability" 

March 9, 2017 

1. Your organization has methodically identified numerous instances in which good science 

was undermined or thwarted by politics from within government, or by powerful 

stakeholders who exert undue influence over scientific research and advisory bodies. 

• How do we prevent such lapses keeping in mind the interplay of influence among 

agencies and regulated entities? 

Preventing such lapses requires a stronger commitment to scientific integrity throughout the 

regulatory process by which policy grounded in science is advanced. Whether the attempts to 

undermine good science come from within or outside of government, a more robust commitment 

to scientific integrity within regulated agencies would make it more difficult to undermine the 

science. Broadly, there are four main elements to improving commitment to scientific integrity 

within agencies: creating a stronger culture of scientific integrity, promoting independent 

science, increasing transparency, and enhancing public participation in the rulemaking process. 

All agencies should have a strong scientific integrity policy, ensure that all employees are made 

aware of the protections within the policy, fully implement and uphold the policy's core 

principles, and regularly evaluate and update the policy. Additionally, agencies may strengthen 

their commitment to scientific integrity by improving disclosures of conflicts of interest in the 

peer review process and on federal advisory committees. For peer reviews, it would be beneficial 

if it were required that all persons in peer review disclose financial ties to interests potentially 

affected by the review. Agencies should consider these disclosures and avoid conflicts to the 

greatest extent possible. Minimization and better disclosure of conflicts of interest for federal 

advisory committees would also be beneficial--one mechanism for increased transparency 

would be to make any conflict of interest waivers granted for committee members easily 

accessible on a public online portal. 

Right now, Congress has a great opportunity to ensure that scientific integrity in research 

and policymaking is protected. Introduced earlier this year, S. 338 would help ensure agencies 

have appropriate scientific integrity policies in place so that federal scientists and policymakers 

could help prevent political interference in the policymaking process. The Senate can also help 

strengthen transparency measures at federal advisory committees by passing H.R. 70, the Federal 

Advisory Committee Act Amendments of 2017, which passed the House earlier this year by 

voice vote. 
82 

2. One of the things that all of you raised in testimony is the need to strengthen governmentwide and agency scientific integrity and conflict of interest policies. 

• Should this be the responsibility of the White House and OMB, or is there a role for 

Congress to play? 

The role of strengthening scientific integrity and protecting policymaking from political 

interference need not be limited to one branch of government. Both the White House and 

Congress can use their respective authorities to help advance scientific integrity in government 

policymaking. 

Currently, there are bills in both the House and Senate that would codify the institution of 

federal agency scientific integrity policies, thus protecting this requirement in perpetuity. These 

bills are a positive step forward and contain several important elements. For example, one 

provision of both bills requires that agencies develop procedures to "identify, evaluate the merits 

of, and address instances in which the scientific process or the integrity of scientific and 

technological information may be compromised." Not all agency scientific integrity policies 

have created strong procedures for investigating and addressing allegation of abuses of scientific 

integrity, and passing a law that requires agencies to create these procedures would help to 

eliminate problems that have arisen within certain agencies because of lack of clarity on the 

topic. 

There is also space for the White House to take further action on scientific integrity. The 

president should appoint an assistant director within the White House Office of Science and 

Technology Policy to coordinate and oversee policies and procedures for ensuring that federal 

actions are informed by the best available science without undue political influence. The White 

House and Congress could also forge a partnership to strengthen scientific integrity, by 

maintaining a commitment to whistleblower protection and preventing retaliation for making 

allegations related to scientific integrity policies, for example. 

3. The Union of Concerned Scientists has raised transparency concerns related to media access 

to government scientists and how changes in journalism create barriers. 

• Keeping in mind what we've heard about the roles of scientists and policy makers, do 

you have any ideas on how agencies can be more responsive to journalists seeking 

agency comment or reaction during reporting? 

There are several ways in which agencies can be more responsive to journalists seeking agency 

comment or reaction during reporting. One place for improvement would be for agencies to 

amend their media policies to remove preapproval as a required condition for interviews. Not all 

agencies have this requirement, but forcing journalists and their scientific sources within 

agencies to navigate through public information officers can- sometimes intentionally, 

sometimes unintentionally-hamper reporting on agency science. If agency public information 

officials do deny interviews, they should inform the journalist of the reason for their decision. 
83 

Additionally, agencies should allow journalists to interview the relevant experts, rather than 

respond to the journalist with talking points or directing the journalist to other employees. It 

would also be helpful for agencies to define "reporter" broadly enough to include freelance 

journalists and new media, since they are sometimes denied the access offered to traditional 

media outlets. There was also a case recently where the FDA used a close-hold embargo; this 

practice is problematic and agencies should refrain from using it. 

4. Much of the discussion about scientific integrity and transparency focuses on the natural and 

physical sciences 

• In general, do you believe the social sciences, computer science, various engineering 

fields and other disciplines are equally rigorous in applying scientific principles? 

In general, the same rigorous scientific principles apply across all sciences, whether the 

distinction is made between "hard" and "soft" sciences or between the physical sciences and 

other sciences. The rigor involved in the scientific process does not change because the subject 

being studied is different. However, it is not feasible for Congress to legislate one-size-fits all 

scientific standards. 

• How do we craft standards of conduct and performance that take into account any 

differences? 

The same standards of conduct and performance should be followed by all scientific disciplines. 

As I outlined in my testimony, a rigorous and credible scientific process relies on the design of 

the study, analytical methods, methods of inference, and the provenance of the work with regard 

to potential conflicts of interest, peer reviews conducted and a comparison of the established 

literature on the subject. The scientific rigor is not determined by the field of study, but rather the 

way in which the scientific process is employed. These standards are well-adhered to by 

scientists in the community, but I believe it is difficult, if not impossible, for Congress to 

legislate some type of"gold standard." There needs to be a certain amount of deference given to 

the scientific community in crafting and implementing standards of scientific integrity. 

5. There is a continuing increase in the number of claims deeming data and science provided by 

industry and used by agencies in rulemaking, to be Confidential Business Information (CBI) 

or proprietary. This of course prevents agencies from publicly disclosing such information in 

conflict with everyone's stated desire for greater transparency. 

• Should we require that each new and existing CBI claim be fully justified by its ownerthat is make them explain how and why disclosure would do irreparable harm? 

Yes. 

• How do we get around the need for agencies to access information and science from 

industry, information and science that businesses legitimately don't want to provide to 

competitors? 
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• How do we get around the need for agencies to access information and science from 

industry, information and science that businesses legitimately don't want to provide to 

competitors? 

Agencies already can protect legitimate confidential business information and should be given 

deference to set up procedures that make the most sense for the businesses that they work with 

and/or regulate. There is nothing wrong with businesses wanting to protect confidential business 

information and proprietary information (this goes for scientists as well). But it is important that 

we do not allow businesses to overuse CBI and proprietary claims to avoid disclosing critical 

information that would help agencies finalize science-based policies. 

6. At the hearing, one witness said that since most Personally Identifiable Information (PII), 

Confidential Business Information (CBI) or proprietary data used in scientific research for 

rulemakings, is electronically formatted, it can be easily redacted to permit public access. 

• Do you agree with this assertion? 

No. 
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Post-Hearing Questions for the Record 

Submitted to Dr. Nancy Beck, Senior Director, Regulatory Science Policy, 

American Chemistry Council 

From Ranking Member Heidi Heitkamp 

United States Senate, Subcommittee on Regulatory Affairs and Federal Management 

Committee on Homeland Security and Governmental Affairs 

"Agency Use of Science in the Rulemaking Process: 

Proposals for Improving Transparency and Accountability" 

March 9, 2017 

I. One of the issues discussed at the hearing is codifying language currently contained in 

Executive Order 12866 concerning the "best reasonably obtainable" science. 

• Do you believe this is necessary and desirable? If so, do you see any potential pitfalls if 

Congress takes this step? 

Response: Yes. It would be very helpful to codify the agencies' commitment to rely on the "best 

reasonably obtainable science". What constitutes the "best reasonably obtainable science" in any 

particular area/matter will be relative as different fields have different standards of excellence. In 

addition, science is always changing. However, this should not prevent agencies from 

committing to rely upon the highest quality evidence. Within any given discipline, one can 

always establish clear criteria by which to judge the quality of scientific information, based on 

current standards (e.g., results of peer review, clarity of assumptions, and discussion of 

uncertainties). Using clear criteria, one can objectively and transparently evaluate evidence and 

subsequently ensure reliance on the best evidence. Codifying best available science will establish 

a mandate that the agencies use clear criteria to evaluate and choose the highest quality and most 

relevant information. 

With an approach like this, the criteria will be stated and the evaluation results will be clear and 

documented. Experts will be able to look back over time and see what the criteria were at a 

certain point and then update evaluations, and perhaps change decisions, as scientific standards 

evolve. Relying on what is known to be the "best reasonably obtainable science" seems like a 

common sense approach to ensuring that the science to support rulemakings is strong. I see no 

pitfalls in codifying this language. 

Finally, please note that in responding to this question I am interpreting "best reasonably 

obtainable science" and "best available science" as being essentially equivalent. While Executive 

Order 12866 (1993) uses the term "best reasonably obtainable scientific, technical, economic, 

and other information," the OMB Information Quality Guidelines (2002), consistent with the 

Safe Drinking Water Act Amendments (1996), uses the term "best available science." "Best 

available science" is also used in Executive Order 13563 (2011). The Lautenberg Chemical 

Safety Act (LCSA) (2016) also uses the term "best available science". For consistency, ACC 

recommends use of the term "best available science." 
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2. Your written testimony notes that stakeholders and indeed consumers may lose confidence in 

government if regulatory decision making is not based upon the best available and highest 

quality science. My question is twofold. 

• First, is an agency or the regulated community ideally best able to determine what 

constitutes the best or highest quality? Second, what more can agencies do to make sure 

they are explaining the science they are relying upon in clear terms understandable to the 

general public? 

Response: Innovation and scientific advancement often takes place in the private sector- and it 

would be a mistake for an agency to ignore the private sector's input in determining what is the 

best available science. Similarly, industry can benefit greatly by coordinating and collaborating 

with Agencies. Thus agencies should work with the public, including the regulated community, 

when making determinations about what constitutes best or highest quality science. If the agency 

is considering criteria to evaluate evidence, the public should have an opportunity to comment on 

and provide input to inform these criteria. 

There is much more the agencies can do to make sure that the science they are relying upon is 

understandable to the public. First and foremost is improving the clarity and transparency about 

scientific decision making. This includes providing clear descriptions of why certain scientific 

information was preferred over other information. It is for this reason that ACC recommends 

providing a definition for best available science in the regulatory text of the EPA framework 

rules that will implement the LCSA. 

3. I agree with your assertion that "improving Federal Agency science should not be as 

challenging as it has been. Significant governmental and non-governmental guidance already 

exists," but is not always followed. 

• To what extent if any is this problem attributable to inadequate Congressional oversight 

of agencies or resource constraints? 

Response: While I don't think the problem is due solely to inadequate oversight, greater 

congressional and public oversight would increase the pressure for agencies to be accountable 

when it comes to following governmental and non-governmental guidance. Resource constraints 

are likely not a concern here; however, perhaps with more resources, agencies could have 

stronger internal oversight mechanisms to ensure that their practices and approaches are 

consistent with best practices. 

4. As you know, this Subcommittee looks at regulatory policy across the entire government. So 

while I agree with the need for better risk analysis and peer review, the fact is not every 

regulator has, or needs a Scientific Advisory Board, Panel or Commission. 

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• How do we improve the overall rigor of regulatory analyses without making every 

agency jump through hoops simply to issue a subject matter rule based upon widely 

accepted technical and scientific consensus? 

• Do you have any concerns that imposing a stringent uniform statutory standard of 

scientific practice and investigation on all agencies invite frivolous debate about matters 

of science long since settled or yet to be thoroughly investigated? 

Response: Many rules rely on risk evaluations or other influential scientific assessments. Using 

transparent and open public comment and peer review processes can provide confidence that the 

scientific underpinnings are robust, without the need for extensive requirements that could 

hamper appropriate regulatory action. 

A uniform standard that lays out the criteria that are used to evaluate "best available science" or 

high quality information should not invite frivolous debate, unless of course a scientific matter 

was settled based on information that was not the highest quality at the time. For instance, to say 

that "best available science" was used means that the information was evaluated based on its 

strengths and limitations and relevance. Ensuring that the agency relied on the highest quality 

information should not be seen as too stringent-it should be seen as ensuring that the best 

inforn1ation was used. The agencies should be able to describe the practices and criteria they 

will use to evaluate scientific evidence (e.g., was it peer reviewed, did it discuss uncertainties) 

and this transparency should help to focus the dialog on discussions about the scientific 

evidence. 

5. There is a continuing increase in the number of claims deeming data and science provided by 

industry and used by agencies in rulemaking, to be Confidential Business Information (CB!) 

or proprietary. This of course prevents agencies from publicly disclosing such information in 

conflict with everyone's stated desire for greater transparency. 

• Should we require that each new and existing CBI claim be fully justified by its ownerthat is make them explain how and why disclosure would do irreparable harm? 

• How do we get around the need for agencies to access information and science from 

industry that businesses legitimately don't want to provide to competitors? 

Response: Agencies do have criteria by which they evaluate CBI claims. For example, EPA's 

criteria under the Toxic Substances Control Act (TSCA) is set forth at 40 C.F.R. 2.208. That 

criteria does not include "irreparable harm," but rather requires a company claiming CBI to 

demonstrate (among several other criteria) that disclosure of the information is "likely to cause 

substantial harm to the company's competitive position or the information is voluntarily 

submitted and its disclosure would be likely to impair the Government's ability to obtain 

necessary information in the future." 

Many companies conduct research that may not be in the public domain. Companies may seek 

to voluntarily submit that scientific research and results to agencies for their consideration, and 

most, if not all, agencies want to have access to those scientific results. That research has 

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potentially significant economic value to the company that has a proprietary interest in it. 

Company's competitors should not have free access to that research without first providing the 

data owner with data compensation. Agencies can and should be willing to either redact the 

relevant commercially sensitive material from the research before making it public or make 

public a robust study summary that recaps the research and its findings. In these circumstances, 

if an interested person wanted to personally review the proprietary material first-hand to verify 

the public characterizations of the research, agencies' should require those interested persons to 

sign a confidentiality agreement that included a requirement that the interested person not use the 

information for any other (competitive intelligence) purpose, subject to financial penalties. 

The recent amendments to the Toxic Substances Control Act require submitters to substantiate 

CBI claims upfront- and notably requires EPA to review all claims to protect confidential 

chemical identity from disclosure, and a representative subset of all other claims. 

It is possible for the agencies to access information that businesses legitimately do not want to 

provide to competitors. This is the current practice and ACC trusts that the agencies have the 

capability to handle this information, and rely upon it as needed, while still protecting CBI. 

6. Here in the regulatory space, the issue of agency resources is always present. 

• What resources are needed to ensure that agencies which rely upon science have access to 

the best reasonably obtainable research data and tools? 

• What additional resources does OIRA need to assess the veracity of agency decisionmaking based in part or whole on scientific evidence? 

Response: Existing resources should be sufficient to ensure agencies rely upon high quality 

science and have access to research data and tools. Agencies currently search for and access a 

large amount of scientific information. Ensuring this information is the highest quality or "best 

available" simply comes down to how the agencies choose what information they rely upon and 

how the agencies justify their choices. Improving the transparency of the process to make those 

decisions will also be required. 

Policy analysts, economists, statisticians, and scientists at OIRA currently strive to assess the 

veracity of scientific evidence relied upon in regulations. With more resources, particularly more 

FTE's, OIRA would likely be able to provide a more in-depth and thorough review of the 

underlying scientit1c analyses. 

7. Much of the discussion about scientific integrity and transparency focuses on the natural and 

physical sciences 

• In general, do you believe the social sciences, computer science, various engineering 

fields and technical disciplines are equally rigorous in applying scientific principles? If 

not, how do we craft one size fits all standards of conduct and performance that take into 

account any differences? 

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Æ 

Response: Social sciences, computer sciences, and other engineering and technical fields should 

be rigorous when applying scientific principles, especially when this information will support 

regulatory decision making. A definition for high quality or best available science, such as the 

one provided in response to question 4, can easily be adapted and applied to many different 

technical fields. A standard that requires Agencies to rely on the highest quality evidence, and to 

transparently justify their choices of scientific evidence, within a particular field, should not be 

overly burdensome. Once there is a standard of conduct making reliance on high quality 

information mandatory, technical experts within agencies can then define the criteria that will be 

used to define what high quality evidence should look like. All the criteria need not be part of the 

broad standard of conduct and performance. 

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