### M ICHAEL P. W ALLS

VICE PRESIDENT

REGULATORY & TECHNICAL AFFAIRS

americanchemistry.com ® 700 Second St., NE | Washington, DC 20002 | (202) 249.7000 September 2 7 , 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) 1 appreciates 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 an d 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, pr oduct 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

env ironmental 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 ass essments 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 Pl an process , and indeed for the program’s overall

success . Unfortunately, the Peer Review Plan s 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 und er the Plan

.

The Work Plan Assessments Are Highly In fluential 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 h a[ve] significant interagency interest.” 2 This definition is also consistent with the definition in the 3 rd 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

.

T he 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 justif

ication for future regulation s, 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_revie w_handbook_2012.pdfDr. 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

ea rly 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 e xample, 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 pe er 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 appropri ate 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 priorit y 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 f or each

of these HISA reviews. T he public comment periods and peer review meetings should be scheduled to permit peer reviewers ample time in advance of the meeting to review public

co mments.

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 o r 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

info rmation 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 2668Dr. 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 ca ndidates 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.

Than k 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