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Dear Stan:

Attached please find EDF’ s comments on the work plan chemical peer review pl ans, which are applicable to each of the five plans. I was unable to attach or uploa d this file using the website, and was told by Pris cilla that you will be able to ensure they are formally received a nd attached as comments to each of the five plans.

Please let me know if there are any questions or co ncerns.

Best regards, Richard 

### EDF comments on EPA work plan chemical peer review plans

Richard Denison
to: Stan Barone 09/27/2012 11:40 AM Cc: Priscilla Flattery, Jennifer McPartland Hide Details From: Richard Denison <rdenison@edf.org>

To: Stan Barone/DC/USEPA/US@EPA

Cc: Priscilla Flattery/DC/USEPA/US@EPA, Jennifer Mc Partland <jmcpartland@edf.org>

History: This message has been forwarded.

EDF comments on workplan chemical risk assessment p eer reviews 9

- 27

- 12 final.pdf 

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...Richard A. Denison, Ph.D.

Senior Scientist

Environmental Defense Fund 1875 Connecticut Avenue NW Suite 600 Washington DC 20009 T 202 387 3500, x 3348 rdenison@edf.org Blog: edf.org/chemandnano Website: edf.org

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...1875 Connecticut Avenue, NW Washington, DC 20009 T 202 387 3500
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Sacramento, CA / San Francisco, CA / Washington, DC / Beijing, China / La Paz, Mexico

Totally chlorine free 100% post

- consumer recycled paper Comments of the Environmental Defense Fund

on EPA’s peer review plans for its risk assessments of work plan chemicals September 27, 2012

These comments address two issues:

 the need to consider individuals drawn from a broad range of organizations in selecting peer reviewers; and

 implications of EPA’s and the Federal Government’s conflict of interest policies for selection of peer reviewers.

N eed to consider individuals dra wn from a broad range of organizations in selecting peer reviewers

We understand from the peer review plans posted by EPA that peer reviewers will be selected by an independent contractor and there is not a nomination process. It is critical, therefore, t hat the contractor consider appropriately qualified individuals drawn from a broad range of organizations, including:

 state and local government agencies

 labor unions and related organizations representing workers

 consumer organizations

 health , environment al and scientific organizations , professional societies, research institutions and individual professionals

 organizations representing health

- effected individuals

 state as well as national environmental organizations

Requirements for avoiding conflicts of interest and appearance of a lack of impartiality : Implications
for s election of peer reviewers for EPA’s risk assessments of work plan chemicals

These comments are provided in response to EPA’s solicitation of comments on its peer review plans for
work plan chemical draft risk assessments. W e first describe requirements applicable to selection of peer reviewers to avoid conflicts of interest and appearance s of a lack of impartiality

. We then discuss the implications of these requirements with respect to the types of individuals that should be excluded from consideration in the panel selection process.Comments of the Environmental Defense Fund

September 27, 2012 Page 2

Requirements

In selecting members of the peer review panels to review the draft risk assessments of work plan
chemical s , EPA and its contractors are required to abide by the Peer Review Policies applicable to all federal agencies’ peer reviews.

EPA’s Peer Review Agenda web page describes procedures for peer review of agency reports and

pu blications. It lists the work plan chemical draft risk assessments as constituting “influential scientific
information ” that are subject to the Office of Management and Budget’s (OMB) 2004 bulletin on peer
review

. The OMB bulletin in turn includes the following requirement: “This Bulletin requires agencies to adopt or adapt the committee selection policies employed by the National Academy of Sciences (NAS)
when s electing peer reviewers who are not government employees.”

In addition, EPA peer reviews are to comport with the agency’s Peer Review Policy and the procedures
of EPA’s Peer Review Handbook , both of which have incorporated the relevant provisions of the OMB bulletin, including its reference to the NAS committee selection policies.

The NAS Committee Selection Policy

The 2003 NAS policy sta tes (page 2): “Subsection 15(b)(1) of FACA further requires that the institution must "make its best efforts to ensure that (A) no individual appointed to serve on the committee has a conflict of interest that is relevant to the functions to be performed, unless such conflict is promptly and publicly disclosed and the Academy determines that the conflict is unavoidable .” The policy goes on to state (page 8) : “A particular individual's conflict of interest may be determined to be unavoidable if, for examp le, the individual's qualifications, knowledge, and experience are particularly valuable to the

wor k of the committee and if the institution is unable to identify another individual with comparable qualifications, knowledge, and experience who does not also have a conflict of interest

. ”

EPA’s Peer Review Handbook

The Peer Review Handbook states (page 60): “ Selection of peer reviewers should be made by identifying reviewers with the appropriate expertise and then narrowing the field of potential peer
reviewers to those individuals that are independent, do not have a conflict of interest and do not appear to l ack impartiality

. ”

An addendum to the handbook provides more specifics on what constitutes “an appearance of a lack of impartiality” and provides illustrative examples. For “experts hired under a contract mechanism,” which
is the means to be used to select the peer review panel s for t he work plan chemical draft risk

assessments , the addendum defines (page 5) an “ appearance of a lack of impartiality ” as occur ring

“ when a n expert participating in a particular matter involving specific parties may cause a reasonable person with knowledge of the relevant facts to question the expert’s ability to carry out official duties without bias or influence

. ”Comments of the Environmental Defense Fund

September 27, 2012 Page 3

Implications for selection of peer reviewers

In EDF’s view, these requirements mean that the panels selected by EPA’s contractor(s) to conduct peer
reviews of EPA’s draft risk assessments of work plan chemicals must ex clude any of the following types
of individuals:

1. Any em ployee of, consultant or con tractor hired by, or other individual affiliated with (e.g., Board member) or receiving funding from any company that produces, processes , sells or uses :

o the substance(s) on which the risk assessment has been conducted, or

o subs tances that compete with or are alternatives to the substance(s) on which the risk assessment has been conducted; and
2. Any employee of, or consultants or contractors hired by, or other individual affiliated with (e.g., Board member) or receiving funding fro m any trade association that includes or otherwise represents a company described in the first item above.

While an exception is provided for unavoidable conflicts of interest where “ the institution is unable to identify another individual with comparable qualifications, knowledge, and experience who does not

a lso have a conflict of interest, ” we consider this circumstance to be highly unlikely to arise with respect to the peer reviews of EPA’s draft risk assessments of work plan chemicals. Should such a circumstance arise, EPA’s contractor should provide and fully document the basis on which it has concluded the conflict is unavoidable, and EPA should promptly provide a full public disclosure of the precise nature of
the conflict , as required by the NAS p olicy

.

Respectfully submitted,

Richar d A. De nison, Ph.D. Senior Scientist