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Interactive Public Docket

COMMENT BY: Lisa K. Friedman, Acting Principal Deputy General Counsel, EPA
SUBJECT: Response to CRE forward of Tom Bartman's Concerns
DATE: October 12, 1999

Mr. Charles J. Fromm
Executive Director
Center for Regulatory Effectiveness
Suite 700
11 Dupont Circle, N.W.
Washington, DC 20036

Dear Mr. Fromm:

In your letter of August 24, 1999, you asked Administrator Browner to respond to comments submitted by Tom Bartman to your organization on August 3, 1999, concerning the applicability of the Federal Advisory Committee Act (FACA) to the Environmental Protection Agency's (EPA) peer review process. On behalf of Administrator Browner, I am responding to your request.

We see no basis for Mr. Bartman's concerns. EPA is committed to a robust peer review policy. EPA has one of the most extensive and active peer review processes in the federal government. A key step in producing credible regulatory decisions supported by well documented scientific data is ensuring that our work is based on broadly accepted scientific studies. An independent peer review is an essential tool for accomplishing this goal. EPA also complies with all applicable open government laws, and believes that it has a good record of carrying out its peer review in a transparent and credible fashion.

Mr. Bartman's comments concern a specific EPA contract under which EPA's contractor convened a peer review panel. Mr. Bartman represented Daniel M. Byrd, a former EPA employee, in challenging that contractor's peer review panel under FACA. As you know, FACA is an open government law that requires that certain committees providing advice or recommendations to federal agencies comply with chartering, open meeting, and balanced membership requirements. In this instance, at the direction of EPA's National Center for Environmental Assessment, EPA's contractor, Eastern Research Group (ERG), convened a peer review panel in July 1997 to evaluate an EPA report concerning the carcinogenic effects of benzene (Benzene Update). The Benzene Update will be used in future EPA proceedings to regulate the industrial emissions of benzene under the Clean Air Act. Mr. Byrd attended the single public meeting of the contractor's panel, and asked for, but did not immediately receive, copies of the "pre-meeting comments" the panelists had exchanged with one another. Mr. Byrd later sued EPA, arguing that the peer review panel was a federal advisory committee subject to FACA and that the records were required to be released under FACA's open meeting requirements.

Subsequent to the filing of the lawsuit, EPA released the pre-meeting comments to Mr. Byrd under the Freedom of Information Act. However, Mr. Byrd asserted that supplying him with the comments after the fact was not sufficient and sought both a court judgment that the peer review panel violated FACA and an injunction prohibiting EPA from using the Benzene Update until it reconvened a panel under FACA to review the document. The United States District Court for the District of Columbia dismissed the action on the sole ground that "the peer review panel is not be to deemed a federal 'advisory committee' under, and subject to the requirements of, FACA."1 Mr. Byrd appealed that decision to the United States Court of Appeals for the District of Columbia Circuit, and, in a 2-1 decision, the panel affirmed the decision of the district court.2

The same court previously had ruled in Food Chemical News. v. Young, 900 F.2d 328 (D.C. Cir.), cert.denied, 498 U.S. 846 (1990), that an expert panel established by a Food and Drug Administration (FDA) contractor pursuant to a contract to provide expert counsel to FDA on issues relating to food and cosmetic safety was not subject to FACA. The court held that the panel was neither "established" nor "utilized" by FDA because the panel was not subject to FDA's managerial controls.3 In finding that the peer review panel in the Byrd decision also was not an advisory committee subject to FACA, the court reaffirmed that the terms "established" and "utilized" should be given a narrow reading for purposes of FACA.

In EPA's case, the court explained that an agency "establishes" a committee only if the agency directly forms the committee; indirectly forming a committee through a contract by "conceiving the need for it" is not sufficient in itself to trigger FACA requirements. The court further reaffirmed that the term "utilized" should not be given its common meaning for purposes of FACA but instead refers to groups subject to "strict managerial controls" by agency officials. The court found that the EPA contractor, not the Agency, had selected the participants on the expert panel, paid for their services, appointed the chairperson, and exercised independent editorial judgment as to the contents of the final report submitted to EPA. The court also pointed out that while EPA's contract gave the Agency the ability to review the membership of the panel and the contractor's report before it was submitted in final, as evidence of EPA's potential control over the panel, EPA had not in fact exercised this control. EPA did not make any changes to the panelists ERG selected or to the final report before ERG submitted it to EPA.

Mr. Bartman seems to believe that this decision will make it easier for federal agencies to avoid FACA. On the contrary, the court reaffirmed that panels that are managed or controlled by the federal government are subject to all the requirements of FACA. EPA complies fully with FACA and routinely conducts Agency-managed peer review through committees chartered under FACA, such as EPA's Science Advisory Board. At the same time, the Agency may legally contract for peer review services, and as long as EPA does not manage or control the contractor's committee, a contractor established and controlled peer review committee is not subject to FACA.

Mr. Bartman expresses concern that EPA "has established a new means of compromising the independence of peer reviews and thereby potentially fudging the production of risk assessments underlying its major rules." Mr. Bartman states his view that "the primary reason for EPA's use of this device may be its interest in avoiding the open government provisions of. . . FACA . . ., but it may well also be interest in ensuring the presence of favored and favorable scientists on peer review panels that review its science." EPA has neither intention. Indeed, I do not see the logic in Mr. Bartman's claims. It would be far easier for an agency to ensure only "favored" scientists were per reviewing work if the agency itself chartered the panel under FACA, which is well within the agency's authority, rather than using a contractor to conduct all aspects of the peer review, including selecting the panel members, as EPA did here. No court has ever overturned an agency's decision regarding selection of members for a FACA committee. However, if an EPA contractor carries out the peer review, under the Byrd decision, EPA must not participate in the selection of individual members, or else, as the court indicated, the committee would be deemed subject to FACA. Therefore, we do not believe that EPA's legitimate use of contractors to carry out peer review activities can fairly be characterized as an attempt to assure that favored scientists participate in EPA's per review process.

Please call Hale Hawbecker of my staff if you have any additional questions regarding this matter.

Lisa K. Friedman
Acting Principal Deputy General Counsel

1 Byrd v. EPA, C.A. No. 97-1923 (D.D.C. May 1, 1998) (Mem. And Order).

2 Byrd v. EPA, 174 F.3d 239 (D.C. Cir. 1999).

3 The court in Food Chemical News relied on a supreme Court decision, Public Citizen v. Department of Justice, 491 U.S. 440 (1989), which held that the term "utilized" does not have its ordinary meaning for purposes of FACA but instead refers, in relevant part, to advisory groups managed or controlled by the federal government.