1 Attachment 

Dear Stan: 

 

Attached please find EDF’s comments on the work plan chemical peer review plans, which are applicable to each 

of the five plans. I was unable to attach or upload this file using the website, and was told by Priscilla that you 

will be able to ensure they are formally received and attached as comments to each of the five plans. 

 

Please let me know if there are any questions or concerns. 

 

 

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 

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From: Richard Denison <rdenison@edf.org> 

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

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

History: This message has been forwarded. 

EDF comments on workplan chemical risk assessment peer 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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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.

Need to consider individuals drawn 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, that 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, environmental 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 selection 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. We first describe requirements applicable to selection of 

peer reviewers to avoid conflicts of interest and appearances 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 

chemicals, 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 

publications. 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 selecting 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 states (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 example, the individual's qualifications, knowledge, and experience are particularly valuable to the 

work 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 lack 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 panels for the work plan chemical draft risk 

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

“when an 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 exclude any of the following types 

of individuals:

1. Any employee of, consultant or contractor 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 substances 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 from 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 

also 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 policy.

Respectfully submitted,

Richard A. Denison, Ph.D.

Senior Scientist