MICHAEL P. WALLS

 VICE PRESIDENT

REGULATORY & TECHNICAL AFFAIRS

americanchemistry.com® 700 Second St., NE | Washington, DC 20002 | (202) 249.7000 

September 27, 2012

Dr. Stan Barone

Peer Review Leader

U.S.EPA Headquarters

Ariel Rios Building

1200 Pennsylvania Avenue, N.W.

Washington, D.C. 20460

Re: Peer Review Plans for EPA Work Plan Risk Assessments

Dear Dr. Barone:

The American Chemistry Council (ACC) 1appreciates the opportunity to comment on the 

August 17, 2012, Peer Review Plans for the risk assessments conducted by the Environmental 

Protection Agency (EPA) on chemicals identified under the Agency’s work plan chemicals. 

ACC members have a significant interest in a peer review process for the risk assessments that is 

not only efficient and effective, but one that fairly and reasonably considers all relevant scientific 

data in each of its assessments in a transparent and robust manner. 

ACC and its members make substantial, ongoing investments in research to support product 

development, product stewardship and regulatory requirements, including investments related to 

the 83 substances the Agency has identified as Work Plan priorities for further review and 

assessment. 

 

1

The American Chemistry Council (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 $720 billion enterprise and a key 

element of the nation's economy. It is one of the nation’s largest exporters, accounting for ten cents out of every 

dollar in U.S. exports. Chemistry companies are among the largest investors in research and development. Safety 

and security have always been primary concerns of ACC members, and they have intensified their efforts, working 

closely with government agencies to improve security and to defend against threats to the nation’s critical 

infrastructure.
Dr. Stan Barone

September 27, 2012

Page 2

ACC commends EPA on its stated plan to publish the Work Plan risk assessments for public 

review and comment, and is particularly pleased that EPA has published its peer review plans for 

comment as well. ACC believes that effective peer review of the assessments is critical to the 

transparency and credibility of the Work Plan process, and indeed for the program’s overall 

success. Unfortunately, the Peer Review Plans provide very little information regarding the 

overarching approach that will be taken, how data and information will be evaluated and 

integrated, and the scope of the evaluation. EPA has stated that the risk assessments will be 

more extensive than a screening level assessment, but less extensive than a more detailed 

technical assessment. Beyond that, however, there are still some significant uncertainties about

the planned scope and approach for conducting the assessments. Based on these concerns, ACC 

offers the following comments as a constructive and practical contribution as the Agency 

considers the Work Plan review process and peer reviews of substances under the Plan.

The Work Plan Assessments Are Highly Influential Scientific Assessments (HISAs)

The 2004 OMB Information Quality Bulletin for Peer Review (OMB Bulletin), defines HISAs as 

assessments that are “...novel, controversial, or precedent-setting or ha[ve] significant 

interagency interest.”2 This definition is also consistent with the definition in the 3rd Edition of 

the EPA Peer Review Handbook.3 It is clear that the risk assessments to be peer reviewed meet 

this definition, and should be treated by EPA as HISA’s to ensure the most robust peer reviews.

The Work Plan chemical assessments conducted, peer reviewed, and published by EPA will, in 

fact, be novel and precedent setting. The assessments will establish the framework under which 

the Work Plan chemical priorities will be evaluated and potentially regulated. However, EPA 

has classified them in the Peer Review Plans as only “influential.” ACC believes that the 

appropriate recognition of the assessments, due to their importance and influence, is to treat 

them as HISAs. 

It is also apparent that the Work Plan chemical risk assessments could be controversial and of 

significant interagency interest. As noted, it is not yet clear what data will be used in the 

assessments and how the information will be evaluated and interpreted. Furthermore, the scope 

of the assessments and the full extent of the decisions they will be used to inform are also 

unclear. EPA has indicated that, in appropriate cases, the assessments will constitute the 

scientific justification for future regulations, some of which will likely have significant economic 

impacts. It is critical that the Work Plan assessments be considered HISAs.

As Highly Influential Scientific Assessments, the Rigor of the Peer Review Process Must be 

Improved

As HISAs, it is critically important that the Work Plan chemical assessments undergo a more 

robust peer review process than is required for Influential Scientific Information, consistent with 

the standards described in the OMB Bulletin. Although HISAs may take more time upfront to 

 

2

See OMB Information Quality Bulletin for Peer Review (the OMB Bulletin) available at: 

http://www.whitehouse.gov/sites/default/files/omb/assets/omb/fedreg/2005/011405_peer.pdf

3

See EPA peer review handbook available at: 

http://www.epa.gov/peerreview/pdfs/peer_review_handbook_2012.pdf
Dr. Stan Barone

September 27, 2012

Page 3

ensure a more transparent and rigorous peer review, the quality of the final product will be more 

robust and independent. A more rigorous peer review process does not necessarily mean that 

EPA will be unduly delayed in completing the assessments. Indeed, a more robust process in the 

early stages will create greater efficiencies on the back-end by ensuring the assessment 

appropriately addresses the comments of a robust peer review panel and those of stakeholders. 

For example, the current Peer Review Plans only identify very generic expertise of individuals 

being considered as peer reviewers. To ensure a robust slate of reviewers, the public, including 

scientific and professional societies, should be asked to nominate peer review candidates. 

Similarly, consistent with the best practices of the National Academies and the EPA Scientific 

Advisory Board, the public should be allowed to comment on the specific reviewers under 

consideration. If EPA fails to ensure the appropriate expertise, independence, and balance on the 

peer review committees, it will undermine the entire review process. In turn, any future 

assessments on the remaining Work Plan priority chemicals will be negatively affected. We 

encourage EPA to follow the OMB Bulletin for expert reviewer selection for HISAs.

EPA’s Peer Review Plans indicate that peer reviews will be conducted by teleconference. ACC 

is concerned that this approach does not encourage the healthy, deliberative discussion that is 

fostered in an in-person meeting. Furthermore, the peer review process should be structured to 

provide sufficient opportunity for robust discussion and consideration of public comments by the 

independent scientific peer reviewers. For some of the Work Plan chemicals, such as long chain 

chlorinated paraffins, EPA identifies the need for expertise in 12 different disciplines. Thus, 

there will be a clear need for a robust dialogue and learning among the chosen reviewers. 

The OMB Bulletin states: “The more rigorous and expensive processes are particularly valuable 

for highly complex, multidisciplinary, and more important documents, especially those that are 

novel or precedent-setting”.4 A teleconference will not foster the dialogue necessary to ensure a 

robust review. We strongly encourage EPA to hold at least one in-person panel meeting for each 

of these HISA reviews. The public comment periods and peer review meetings should be 

scheduled to permit peer reviewers ample time in advance of the meeting to review public 

comments. 

While EPA has not described how it will respond to the peer review and public comments, due to 

the importance of these assessments, it is crucial that EPA provide a transparent response to the 

peer review report explaining the agency’s agreement or disagreement with the views expressed 

in the report. Similarly, EPA should respond in writing to the public comments. This step is 

critical if, as EPA anticipates, the assessments will be the basis for future regulatory action.

More Detailed Information is Required for the Peer Review Plans to be Useful

Beyond the designation as an HISA, the Peer Review Plans appear to meet the most basic 

standards of the OMB Bulletin and EPA Handbook. Nevertheless additional, more detailed 

information is needed in order for the plans to be truly useful and informative to the public and 

stakeholders. For example, EPA did not provide any information regarding the scope of the 

assessments. Are the assessments to be focused on human health issues, environmental issues, 

 

4

See the OMB Bulletin at page 2668
Dr. Stan Barone

September 27, 2012

Page 4

or both? Some of the Peer Review Plans describe the need to enlist disciplines with expertise in 

ecology, while others make no mention of ecology. 

Others mention a need for expertise in biology-embryology, but it is not clear what species in 

which EPA is interested. For example, an expert in human reproduction may not be able to 

answer questions related to reproduction in aquatic species. Consequently, if stakeholders or 

members of the public were interested in nominating expert candidates to EPA, the Peer Review 

Plans are not sufficiently informative to inform stakeholder/public input. EPA should use the 

Peer Review Plans to specifically identify the ecological or human endpoints that will be the 

focus of the risk assessments.

Thank you again for the opportunity to comment on the Peer Review Plans and for considering 

our comments, and please do not hesitate to contact me, Christina Franz or Nancy Beck of the 

ACC staff if you have any questions regarding the concerns we have raised.

Sincerely,

Michael P. Walls

Vice President

Regulatory & Technical Affairs

CC: Wendy Cleland-Hamnett

Boris Bershteyn, OMB

Dominic Mancini, OMB