Amicus Curiae Brief — Byrd v. Environmental Protection Agency

Supreme Court, y. S.

99-986] *>

FEB 9 2000

In the Supreme Court of th United State

¢ st

DANIEL M. BYRD,

PETITIONER,

V.

ENVIRONMENTAL PROTECTION AGENCY

RESPONDENT.

¢

ON PETITION FOR WRIT OF CERTIORARI TO

THE UNITED STATES COURT OF APPEALS

FOR DISTRICT OF COLUMBIA CIRCUIT

¢

BRIEF AMICUS CURIAE OF

PATRICIA A. BUFFLER, ERNEST L. DAMAN,

SHELDON LEE GLASHOW, MICHAEL GOUGH, JOHN D.

GRAHAM, NATHAN R. HURT, DANIEL M. KAMMEN,

A. ALAN MOGHISSI, RODNEY NICHOLS, FREDERICK

SEITZ, CHARLES O. VELSY, ELIZABETH M. WHELAN,

JAMES D. WILSON, AND RICHARD WILSON

IN SUPPORT OF PETITIONER

4

MARTIN S. KAUFMAN*

* Counsel of Record

Edwin L. Lewis

Atlantic Legal Foundation

205 East 42nd Street, 9th Floor

New York, NY 10017

(212) 573-1960

Counsel for Amici Curiae

TABLE OF CONTENTS

I i ee es ag ace ws cee i

er I SiC o/s cn Sete b Salk galore ii

EEE ee ee re l

8 Rn a ee re or 2

I oo en eR IN ie i bad chan kaeted 6

A WRIT OF CERTIORARI SHOULD BE

GRANTED BECAUSE THE DECISION OF

THE COURT OF APPEALS THREATENS

THE INTEGRITY OF THE PEER REVIEW

AND THE REGULATORY PROCESS ............. 6

I. SCIENCE IS INCREASINGLY AN

IMPORTANT FACTOR IN

FORMULATING PUBLIC POLICY .......... 6

II. INDEPENDENT PEER REVIEW IS VITAL

FOR ENSURING THAT REGULATORY

REGIMES ARE BASED ON VALID SCIENCE

AND ARE NOT ARBITRARY AND

eee re tee eee ee ee 8

Ill. ©THE DECISION OF THE COURT OF

APPEALS THREATENS THE INDEPENDENCE

OF SCIENTIFIC PEER REVIEW ........... 9

IV. THE “CONTRACTOR EXEMPTION"

IS INCONSISTENT WITH FACA .......... 1]

eee hl erry ees ee ee eee ee ee 16

TABLE OF AUTHORITIES

page

Cases

Animal Legal Defense Fund v. Shalala, 104 F.3d 424

(D.C. Cir. BGT) 2.6. cinan sas ebaeen eee 13 fn. 10

Association of Am. Physicians & Surgeors v. Clinton,

997 F.2d S96 (D.C. Cie. BGR no cues 65 ee tues 14

Byrd v. EPA, 174 F.3d 239, 241 (D.C. Cir. 1999) ... passim

Cargill, Inc. v. U.S., 173 F.3d 323 (Sth Cir. 1999) ... 11,14

Daubert v. Merrell Dow Pharmaceuticals,

SOD US. SID CUSED onc kk cou Sd Beak eeNa sewn 8

Food Chem. News v. Young, 900 F.2d 328

(D.C. Cle. 19GED . os ce cdeuannkaawueee 5, 13 fn. 10

Kumho Tire Co. v. Carmichael, __ US. __,

329 S.Ce. 1967 CRUUED. 6 on dccsnceuuees aso 8

Public Citizen v. United States Dep't of Justice,

491 U.S. 440 (ISG o's. Wass cuuees Bi oy ths 39 Mm. 10

Statutes

Clean Air Act, 42 U.S.C. §§7401-7671q .............. 2

1990 Clean Air Act Amendments,

42 U.S.C. §7412(b)(2) and 42 U.S.C. §7412(d) ... 3fn.4

Federal Advisory Committee Act,

Bin toy” Ff | were passim

lil

Federal Advisory Committee Act Amendments,

ped. 1... 206-153 Cie 7; 1987} ee ee. 12

Regulations

41 C.F.R. § 101-6.1007(b)(2)(iii) (1997) ......... 12 fn. 8

"Carcinogenic Effects of Benzene: An Update,"

62 Fed. Reg. 35172-35173 (June 30, 1997) ........ 4,15

Miscellaneous

Stephen G. Breyer, The Interdependence of

Science and Law, Science 280:537 (April 24, 1998) ... 6-7

Byrd Declaration, 17 22-13

(Pet. App. Section C at C-12-C-13) .......... 10 fn. 6

EPA, "ORD. Standard Operating Procedures for Peer

Review of Sci. or Techn. Work Products." (Sept. 30, 1994) 7

EPA, Office of Res. & Dev., Carcinogenic Effects of

Benzene: An Update, (EPA/600/P-97/001F, April 1998) . 5

EPA, Office of Science Policy, Office of Research

and Development, Science Policy Handbook,

Peer Review, EPA 100-B-98-001 (Jan. 1998) ... 9, 10-11

Statement of Sen. Metcalf, 118 Cong. Rec. $14647

(Sept. 12, 1972), reprinted in McMurtry, V.,

Fed. Advisory Comm. Act (Pub. L. 92-463),

Source Book: Legislative History, Texts, and

Other Documents at 158 (Cong. Res. Serv. 1978) ..... 3

Statement of Rep. Waxman in support of H.R. 2977,

1997 Cong. Rec. at H10581 (Nov. 9, 1997) ..... 12 fn. 9

1

INTEREST OF AMICI

Amici’ are scientists, scholars and teachers of science, public

health and public policy and consultants. Amici include a

Nobel! Laureate in physics, the president emeritus of one of the

most prestigious research universities in the world, the chief

executive officer of one of this nation’s oldest and most

prestigious scientificsocieties, former presidents or chairpersons

of important learned societies in fields of science and

technology, former government officials (some of whom worked

in senior science positions for the Environmental Protection

Agency or for Congress). The fields of expertise of amici

include chemistry, physics, risk analysis, toxicology,

epidemiology and engineering (including, of particular relevance

to this case, environmental sciences); many of them have

earned doctorates in various fields of science. Many are or

have been editors and contributors to scientific and other

scholarly journals, and are authors of authoritative works in

their respective areas of expertise. Some are professors at

highly regarded institutions of higher education in the United

States’. They hold many other distinctions for achievements in

fields of science and academia. Amici are authors of numerous

articles, studies, monographs and textbooks. Many are

' Pursuant to Supreme Court Rule 37.6, amici curiae state

that this brief was not prepared, written, funded or produced by any

person or entity other than amici curiae or their counsel.

Counsel for the parties have consented to the filing of this

brief. Letters of consent have been filed with the Clerk of the Court.

Amici appear in their individual capacities, and not as

representatives of the organizations or institutions with which they are

affiliated.

2

frequently called upon to serve on official commissions, review

boards, advisory committees and institute’.

Amici express no view as to the appropriateness of EPA’s

benzene regulations. Amici appear solely to inform the Court

of their views as to the importance of peer review in evaluating

scientific data, theories and conclusions, and the importance of

science and peer review in the formulation of public policy as

embodied in legislation or regulations.

STATEMENT OF THE CASE

Amici will not burden the Court with a detailed recitation of

the relevant statutory provisions and the factual background of

this case (for that they adopt the narrative contained in the

Petition herein), but will merely highlight the most significant

elements of each.

A. The Statute

The Federal Advisory Committee Act, 5 U.S.C. App. II

("FACA"), provides that "advisory committee’ means any

committee, board, commission, council, conference, panel, task

force, or other similar group. . . which is. . . established or

utilized. . . by one or more agencies, in the interest of obtaining

advice or recommendations. .. ." FACA § 3. FACA applies to

"each" advisory committee. FACA § 4. FACA’s requirements

include opening each advisory committee meeting to the public

and allowing attendance by interested persons, and making

available for public scrutiny the records, reports, drafts, and

studies made available to each advisory committee. FACA §

10(a) & (b).

*. The qualifications of amici, the positions they hold and

have held, and the scholarly honors and distinctions they have earned

are set forth in the biographical appendix to this brief.

Dalal Aca a

3

A major purpose of FACA is to ensure "disclosure and

objective counsel,” so that the public will know what advice the

Government is getting and how they might add "to the

information process." Statement of Sen. Metcalf (floor

manager), 118 Cong. Rec. $14647 (Sept. 12, 1972), reprinted in

McMurtry, V., Fed. Advisory Comm. Act (Pub. L. 92-463),

Source Book: Legislative History, Texts, and Other Documents

at 158 (Cong. Res. Serv. 1978). See also Public Citizen v.

United States Dep't of Justice, 491 U.S. 440 (1989).

B. The Regulatory Background

Benzene is a chemical manufactured in high volume and is

widely used as a component of gasoline and in a wide range of

industrial processes and specialty chemicals. Benzene can cause

acute myelocytic leukemia in humans, and EPA has regulated

it as a hazardous air pollutant under the Clean Air Act, 42

U.S.C. §§7401-7671q, because of its carcinogenic effect.

The initial risk assessment* for benzene, drafted by EPA’s

Office of Research and Development ("ORD") was peer

reviewed by EPA’s Science Advisory Board, which operat

under FACA guidelines. ORD subsequently updated the

benzene risk assessment, but did not subject the update to

scientific peer review, although EPA used the updated benzene

* The 1990 Clean Air Act Amendments require EPA to

promulgate emissions standards for major sources and source

categories of designated hazardous air pollutants ("HAPs"), including

benzene. 42 U.S.C. §7412(d). EPA is required to consider the risks

posed by exposures to particular HAPs in setting standards for HAP

emissions. See, e.g., 42 U.S.C. §7412(b)(2). A risk assessment employs

statistical methods to analyze the findings of scientific studies on the

effects of exposure of humans or animals to chemical substances in

order to extrapolate from such data to a numerical estimate of the

risk of occurrence of symptoms in humans from defined exposure

doses.

4

risk assessment as the basis for additional Clean Air Act

regulations.

C. The Benzene Advisory Committee

In 1992 EPA’s Office of Mobile Sources asked ORD to

provide another update of the human carcinogenic risks of

inhaled benzene. In 1997 a Federal Register notice announced

a peer review workshop scheduled for July 16, 1998 and public

review of ORD’s draft update. "Carcinogenic Effects of

Benzene: An Update." The Federal Register notice also stated

that Eastern Research Group ("ERG"), an EPA contractor,

would provide logistical support for the peer review workshop,

and that after the workshop, EPA would "consider the

peer-panel and public comments before preparing a final report

for the Office of Mobile Sources." 62 Fed. Reg. 35172-35173

(June 30, 1997).

D. The Role of EPA’s Contractor

Under EPA’s Statement of Work, ERG was, among other

tasks (many of them purely ministerial), to select committee

members from a list provided by EPA and from its own list and

submit its choices for EPA approval, designate the panel

chairperson in "consultation with EPA" and draft and send a

summary report of the committee meeting to EPA prior to

finalizing the report. See Byrd v. EPA, 174 F.3d 239, 241 (D.C.

Cir. 1999) (hereafter "Byrd"). EPA reserved the authority to

approve or disapprove ERG’s proposed choices of committee

members and the committee chair. See Byrd at 241, 247.

EPA did, in fact, provide ERG with a list of "acceptable"

panel members, and four of the six members of the panel came

from this list. Byrd at 241. "EPA held a teleconference with

ERG and the selected panelists, during which the panelists were

instructed to prepare pre-meeting comments on the draft

Benzene Update ‘specifically addressing a series of questions

that [EPA] had provided to ERG. The panelists circulated

5

their pre-meeting notes among themselves and provided a copy

to EPA." All of this occurred before EPA provided any public

notice of the formation of the Benzene panel. Jd. at 241.

The report of the public meeting, with committee member

comments, was finalized and was adopted by EPA. See EPA,

Office of Res. & Dev., Carcinogenic Effects of Benzene: An

Update, at v, (EPA/600/P-97/001F, April 1998) (final

document).

E. The Court of Appeals Decision

The majority in the Court of Appeals for the District of

Columbia held that EPA had not "established" or “utilized” the

benzene advisory committee for FACA purposes. Byrd v. EPA,

174 F.3d at 245. It cited Public Citizen v. Dept. of Justice, 491

U.S. 440 (1989), for the proposition that "an advisory panel is

‘established’ by an agency only if it is actually formed by the

agency. ...’ , 174 F.3d at 245. The D. C. Circuit also stated

that the analysis of whether an advisory committee has been

"established" does not turn on who determines the methodology

and operation of the committee, and concluded that ERG, not

EPA, had established the committee. Jd. at 246-247. Although

the panel majority recognized that "the contract between ERG

and EPA afforded EPA significant potential authority in the

panel selection process," 174 F.3d at 247, it held that because

EPA had not fully exercised the authority it had reserved over

the benzene committee’s activities and because there was "no

reason to assume that the threat of an EPA veto affected

ERG’s panel selections," it had not shown that EPA had

"established" the benzene committee. Jd.

The Court of Appeals majority also held, based on what it

characterized as the Supreme Court’s "narrow" interpretation

of the term “utilized” in Public Citizen, supra, that while

utilized’ encompasses a group organized by a nongovernmental

entity, this is so only where the group is "nonetheless so ‘closely

tied’ to an agency as to be amenable to ’strict management by

ee

6

agency officials.” /d. at 246 (citing Food Chem. News v. Young,

900 F.2d 328 at 332-333 (D.C. Cir. 1990)). It held that EPA’s

involvement in the benzene committee did not constitute the

requisite strict management. /d.°

ARGUMENT

A WRIT OF CERTIORARI SHOULD BE

GRANTED BECAUSE THE DECISION OF

THE COURT OF APPEALS THREATENS

THE INTEGRITY OF THE PEER REVIEW

AND THE REGULATORY PROCESS

I. SCIENCE IS INCREASINGLY AN

IMPORTANT FACTOR IN FORMULATING

PUBLIC POLICY

In a recent speech to the American Association for the

Advancement of Science and in a follow-up article in the

journal Science, Justice Breyer noted

As society becomes more dependent for its well-

being upon scientifically complex technology, we

find that this technology increasingly underlies

legal issues of importance to all of us.

****

* The Court of Appeals noted that "If the benzene panel was

in fact an "advisory committee" subject to FACA as defined by 5

U.S.C.App. Ii § 3(2), both parties agree that the panel functioned in

violation of FACA. Among other things, ’the records, ... working

papers ... or other documents which were made available to ... each

advisory committee shall be available for public inspection and

copying, FACA, 5 U.S.C.App. II § 10(b), and "[d]etailed minutes of

each meeting of each advisory committee shall be kept.’ Id. § 10(c).

Byrd at 242.

7

The importance of scientific accuracy in the

decision of such cases reaches well beyond the

case itself. A decision wrongly denying

compensation in a toxic substance case, for

example, can deprive not only the plaintiff of

warranted compensation but can discourage

other similarly situated individuals from even

trying to obtain compensation and can

encourage the continued use of a dangerous

substance. .. .The upshot is that we must search

for law that reflects an understanding of the

relevant underlying science, not for law that

frees companies to cause serious harm or forces

them unnecessarily to abandon the thousands of

artificial substances on which modern life

depends.

Stephen G. Breyer, The Interdependence of Science and Law,

Science 280:537 (April 24, 1998).

Amici submit that understanding and application of the

relevant underlying science is as important in the formulation

of regulatory regimes, which often have a significantly broader

impact than a particular case or even a series of litigations.

Of particular relevance to this case, EPA itself deemed the

benzene assessment its Category I, EPA’s highest category for

determining the level of appropriate peer review, a category

that includes "Major Scientific or Technical Work Products.” See

Byrd 174 F.3d 239, 244. EPA reserves Category I for

"regulatory/technical products" of the kind that support "major

regulatory decisions or policy/guidance of major impact," and

that "establish a significant precedent, model, or methodology

... or address controversial issues. See EPA, "ORD. Standard

Operating Procedures tor Peer Review of Sci. or Techn. Work

Products". (Sept. 30, 1994) at 8. J.A. 125.

no OR mate sn it el ea conic

8

Il. INDEPENDENT PEER REVIEW IS VITAL

FOR ENSURING THAT REGULATORY

REGIMES ARE BASED ON VALID SCIENCE

AND ARE NOT ARBITRARY AND CAPRICIOUS

Peer review, while not guaranteeing that particular methods

of scientific theories, data or conclusions are accurate, are vital

means of permitting the scientific community to examine the

data, to understand them, to test them, to evaluate the

investigator’s methods and findings, and to show either that the

data or methods of a particular scientist are correct and

appropriate and lead to valid conclusions or that they are not

correct and thus do not lead to valid conclusions.

The importance of peer review in ensuring the integrity and

validity of scientific and technical data and findings was

recognized by this Court in Daubert v. Merrell Dow

Pharmaceuticals, 509 U.S. 579, 593-594 (1993):

Another pertinent consideration is whether the

theory or technique has been subjected to peer

review and publication. . . . [S]ubmission to the

scrutiny of the scientific community is a

component of "good science,” in part because it

increases the likelihood that substantive flaws in

methodology will be detected. See J. Ziman,

Reliable Knowledge: An Exploration of the

Grounds for Belief in Science 130- 133 (1978);

Relman and Angell, How Good Is Peer

Review?, 321 New Eng.J.Med. 827 (1989). The

fact of publication (or lack thereof) in a peer-

reviewed journal thus will be a relevant, though

not dispositive, consideration in assessing the

scientific validity of a particular technique or

methodology on which an opinion is premised.

See also Kumho Tire Co. v. Carmichael, __U.S.__, 119 S.Ct.

1167, at 1175-76 (1999).

9

The EPA itself has recognized the importance of independent

and objective peer review of scientific or technical judgments.

In its Science Policy Council Handbook Peer Review, EPA

described the peer review process in the following words:

1.2.1 Why use Peer Review?

Peer review is intended to uncover technical

problems or unresolved issues in a preliminary

(or draft) work product through use of

independent experts. This information is then

used to revise that draft product so that the

final work product will reflect sound technical

information and analyses. Peer review is a

process for enhancing a scientific or technical

work product so that the decision or position

taken by the Agency, based on that product, has

a sound, credible basis.

EPA, Office of Science Policy, Office of Research and

Development, Science Policy Handbook, Peer Review, EPA

100-B-98-001 (Jan. 1998) (available at http://www. epa . gov/

ordntmt/ORD/spc/perevmem.htm (emphasis in original).

Ill. THE DECISION OF THE COURT OF

APPEALS THREATENS THE INDEPENDENCE

OF SCIENTIFIC PEER REVIEW.

The decision of the Court of Appeals threatens a public

interest which is perhaps even more far-reaching than the

emasculation of FACA. The advisory committee at issue here

was a peer review panel. Peer review is the crucial,

independent validator of important scientific judgments.

Contractors often depend on agencies for their economic

survival. Some scientists are influenced by the potential for

receiving grant money from the government. If an agency uses

its power of veto or the more subtle "power of suggestion" over

10

the contractor to effectively exclude from peer review panels

scientists whom the agency apprehends will be "too

independent,” then the process and purpose of peer review is

distorted. This is exacerbated if scientists who are not on the

peer review panel are prevented from obtaining data and other

information about the panel’s work so that they may critique it

free from the influence of the agency or the agency’s agent, the

contractor®.

The specific event that triggered this case is the withholding

from Dr. Byrd of data that was important or necessary to

enable him, as a knowledgeable and interested member of the

public, from fully and intelligently commenting on the work of

the benzene peer review panel. Data are the lifeblood of

science, and without full access to data scientific judgments

cannot be properly scrutinized. Indeed, it can be said that full

disclosure of data is the sine qua non of peer review’.

Without access to all available information, the interested

public, and particularly outside experts such as Dr. Byrd, are

prevented from "uncover[ing] technical problems or unresolved

issues" and ensuring "that the final work product will reflect

sound technical information and analyses." EPA, Office of

Science Policy, Office of Research and Development, Science

* In this case, EPA’s close supervision of committee

membership selection resulted in inclusion of a scientist whose earlier

contract work for EPA on the health effects of benzene was included

in the very documentation that was under review by the committee.

Byrd Declaration, 1] 22-13. (Pet. App. Section C at C-12-C-13).

” While peer review in the EPA regulatory process has a

somewhat different purpose than peer review for publication, we

believe that the differences are not material or substantial. For

purposes of assuring that EPA’s practices and regulatory decisions are

grounded in good data and valid analytical methods, independent

peer review, and public access to the data and to the peer review

panel's process are necessary.

1]

Policy Handbook -- Peer Review, EPA 100-B-98-001 (Jan.

1998)

IV. THE "CONTRACTOR EXEMPTION"

IS INCONSISTENT WITH FACA’S PURPOSE.

Without any basis in the statutory language and purpose of

FACA, the Court of Appeals created an exemption that is

readily invoked by federal regulatory agencies and provides a

simple way for them to evade FACA. FACA contains no such

exemption, nor does its legislative history (see Judge Williams,

dissenting in part: "it seems to me inconsistent with the

Statute’s language and intent to exempt from FACA a panel

controlled so closely in membership and purpose." Byrd v. EPA,

174 F.2d at 249) or rulings of this Court. Under the broad

holding of the Court of Appeals in this case, an agency that

seeks advisory committee advice need only hire a contractor to

perform essentially ministerial functions, while retaining

effective control over the membership, direction and substantive

work of the committee. This would enable the agency to avoid

responsibilities of accountability to Congress and openness to

the public.

The principal purpose of FACA is to ensure that ". . . the

Congress and the public . . . be kept informed with respect to

the number, purpose, membership, activities, and cost of

advisory committees." 5 U.S.C.App. 2 § 2(b)(5). In Public

Citizen v. United States Dep’t of Justice, 491 U.S. 440, 453 (1989)

this Court noted that public and congressional scrutiny is

intended to further FACA’s overall objective of avoiding the

"expenditure of public funds for worthless committee meetings

and biased proposals." (emphasis added). See also Cargill, Inc.

v. U.S., 173 F.3d 323, 329 (Sth Cir. 1999) ("FACA is designed

to ensure that advisory committees are fairly constituted and

properly monitored so that they will provide sound advice.").

This purpose is implemented by requirements in the statute and

Pe bed at sew,

12

implementing regulations that are intended to ensure that

advisory committees are objective’.

The 1997 Federal Advisory Committee Act Amendments,

Pub. L. 105-153 (Dec. 17, 1997) strengthened FACA’s openness

requirements, and closed a "loophole," by providing, inter alia,

that agencies may not use the advice or recommendations of

the National Academy of Sciences unless specific FACA

procedural requirements (including public notice of meetings

and publication of summaries of meetings that are closed) are

met. The 1997 amendments reiterate that FACA’s purpose is

to safeguard "the public’s right to know about the advisors and

procedures used to produce technical or policy advice for the

government."” This recent amendment of FACA indicates that

the broad exemption to FACA found by the Court of Appeals

is contrary to Congress’ intent. Indeed, the FACA

Amendments of 1997, prohibiting agency use of National

Academy of Sciences committees without compliance with

* FACA § 5(b)(2) states that each advisory committee must

have membership that is "fairly balanced in terms of the points of

view represented." 5S U.S.C.App. 2 § 5(b)(2). The regulations

implementing FACA require that the agency overseeing an advisory

committee have a "plan" to ensure "fairly balanced membership" and

to ensure that "the agency will consider a cross-section of those

directly affected, interested, and qualified, as appropriate to the

nature and functions of the committee." See 41 C.F.R. § 101-

6.1007(b)(2)(iii) (1997).

Section 5(b)(3) of FACA requires federal agencies to make

“appropriate provision[ ] to assure that the advice and

recommendations of the advisory committee will not be

inappropriately influenced by the appointing authority or by any

special interest, but will instead be the result of the advisory

committee's independent judgment.” 5 U.S.C.App. 2 § 5(b)(3).

* Statement of Rep. Henry W. Waxman in support of H.R.

2977, 1997 Cong. Rec. at H10581 (Nov. 9, 1997).

13

openness requirements, reflects concern over agency use of the

National Academy to evade FACA".

Under these amendments, an agency can no longer avoid

FACA’s mandatory requirements designed to ensure openness,

accountability and objectivity by utilizing an advisory committee

tormed by the National Academy of Sciences, whose reputation

tor scholarship is well-established, but under the Court of

Appeals’ decision it can evade those requirements by hiring a

far less august, prestigious, reputable and independent

contractor to organize the advisory panel. This result is absurd,

and renders nugatory the central objective of FACA”’.

°° By adopting the 1997 amendments, Congress confirmed

the D.C. Circuit’s holding in Animal Legal Defense Fund v. Shalala,

104 F.3d 424 (D.C. Cir. 1997), in which Judge Silberman, writing for

a unanimous court, held that the National Academy of Sciences was

subject to FACA. In that opinion, Judge Silberman pointed out the

narrowness and somewhat contorted reasoning of Public Citizen. We

submit that Public Cinzen can be distinguished, because there the

ABA Committee accepted no public funds, whereas here ERG clearly

did accept public funds, and was really nothing more than a conduit

for EPA’s funding of the benzene advisory committee. See Animal

Legal; Defense Fund, 104 F.3d at 428.

The court in Animal Legal Defense Fund also explained quite

clearly why Food Chemical News v. Young, 900 F.2d 328 (D.C. Cir.

1990), on which the Court of Appeals in this case relied so heavily,

is inapposite: in Food Chemical News the committee was formed by

a wholly private scholarly organization and "was not amenable to [any]

management by [FDA| officials,” quoting Food Chemical News, 900

F.2d at 333, which in turn was quoting Public Citizen, 491 U.S. at 457-

458.

"The American Society of Mechanical Engineers, for

example, assists government agencies in conducting peer reviews; but

when ASME administers advisory committees, it requires complete

independence, and refuses assignments where the agency seeks to

control or guide the society's advisory panel. Similarly, one of the

amici is chief executive of a non-profit institute that acts as a

Pe eT

+ i sini a ta ta a la dh ala sil

bk Cesceinie te ALN =

14

The Court of Appeals in this case recognized that EPA's use

of contractors to convene advisory committees was a continuing

practice. 174 F.3d at 244 n.4.; id. at 248, yet it created an

exemption that creates a simple and obvious way to circumvent

FACA. As the Fifth Circuit noted in Cargill, Inc. v. U.S., supra,

at 341 "If FACA has no teeth, the work product of spuriously

formed advisory groups may obtain political legitimacy that it

does not deserve. See also Association of Am. Physicians &

Surgeons v. Clinton, 997 F.2d 898, 913 (D.C. Cir.1993). It is for

this reason that amici believe that this Court should grant the

petition and that the Court of Appea!s decision in ‘this case

should be reversed. R

The Court of Appeals’ holding that EPA had not

"established" the benzene advisory committee relied largely on

the majority’s theoretical distinction between possession of veto

power and actual use of that power. We believe that this is, in

the realities of government process, a false distinction. The

majority itself stated that EPA had reserved "significant

potential authority" over the contractor’s selection of committee

members, and stated that "[t]he result in this case might have

been different if EPA had exercised its [veto] authority . . ." it

concluded that "there is no reason to assume that the threat of

an EPA veto affected ERG’s panel selections." Byrd, 174 F.3d

at 247. This, we submit is naive.

government contractor for the purpose of providing credible peer

review of agency sponsored projects; the institute contracts with

ASME to set up the panel to advise the institute. The institute solely

determined to use ASME, and the government agency does not

participate at all in the selection of members of the peer review

panel, nor does it have any power, not even residual power, to

influence the panel’s work. Thus, unlike the advisory committee in

this case, the ASME panels comply strictly with the criteria set down

in Food Chemical News. The ASME panels’ process is open, and they

operate under procedures equivalent to the FACA mandates the

National Academy of Science must follow under the 1997

Amendments.

1S

Judge Williams’ dissent pointed out the weakness of this

reasoning, noting that

The veto power is key. That it was not used in

the benzene episode does not much help EPA:

not only may EPA exercise it in future

applications of the policy, but the contractor was

and is quite likely to take the fact of veto power

into account in its selection decisions. Assuming

that contractors will ignore this fact--as the

majority appears to do--seems akin to believing

that the President takes no account of senators’

opinions when he nominates federal judges.

174 F.3d at 249 (citation omitted).

Judge Williams’ analogy of the potential of an agency’s veto

power Over appointments to peer review panels to presidential

judicial nominations actually exaggerates a_contractor’s

independence, because unlike the President, who is co-equal

with the Senate, with powers that can be used as leverage over

individual Senators and the body itself, the contractor is in a

completely subordinate position vis-a-vis the agency because a

contractor like ERG often depends for its lifeblood --

government contract revenues -- on the goodwill of the

contracting agency.

EPA in fact involved itself in the contractor’s choice of

committee members and the committee chair; in drafting of the

committee’s meeting agenda; and in conveying the charge to the

committee. EPA publicly described the benzene peer review

committee as an EPA committee, and the contractor’s role as

merely providing logistical support. 62 Fed. Reg. at 35173; see

Byrd, 174 F.3d at 249 (Williams, J., dissenting)

16

CONCLUSION

Because this case presents an issue of great public

importance, amici support Petitioner's request that the Court

grant the petition for a writ of certiorari.

Dated: February 9, 2000

Respectfully submitted,

MARTIN S. KAUFMAN,

Counsel of Record

ATLANTIC LEGAL FOUNDATION

205 East 42nd Street - 9th Floor

d New York, New York 10017

| (212) 573-1960

Counsel for Amici Curiae

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BIOGRAPHICAL APPENDIX

PATRICIA A. BUFFLER is Professor of Epidemiology at and

tormerly Dean of the School of Public Health of the University

of California at Berkeley. Dr. Buffler is a Fellow of the

American College of Epidemiology, and was President of that

organization in 1991-1992. She is a member of the Institute of

Medicine of the National Academy of Sciences and a Fellow of

the American Association for the Advancement of Science.

ERNEST L. DAMAN is Chairman Emeritus of Foster Wheeler

Development Corporation and was previously Chairman of the

Board ot Foster Wheeler Development Corporation and before

that was Director of Research of that company. He is a Past

President of American Society of Mechanical Engineers. Mr.

Daman is a member of the National Academy of Engineering,

a member of the American Association for the Advancement

of Science and Past Chairman of the American Association of

Engineering Societies and a Fellow of the Institute of Energy

(England). He is the author of numerous papers, and holds 18

patents. He was responsible for the design and development of

a combined steam gas turbine plant, fluidized bed combustion,

fast breeder reactor components, supercritical steam generators,

environmental control processes, and advanced high-efficiency

power generation systems.

SHELDON LEE GLASHOW is a Nobel Laureate in Physics

and Mellon Professor of Physics at Harvard University.

MICHAEL GOUGH is a consultant in risk analysis,

epidemiology and toxicology. He was the Director of Science

and Risk Studies at the CATO Institute in Washington, DC.

He also served as the Manager of the Biological and Behavioral

Sciences Program in the Office of Technology Assessment, U.S.

Congress. Dr. Gough earned a Ph.D. in Biology from Brown

University. He has taught microbiology at Baylor College of

Medicine and at the State University of New York.

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JOHN D. GRAHAM is Director of the Center for Risk Analysis

of the Harvard University School of Public Health and

Protessor of Public Policy and Decision Sciences in the

] Department of Health Policy and Management at the Harvard

: University School of Public Health. He was previously Director

of the Center for Injury Control at the Harvard University

School of Public Health. He is the author or co-author of over

100 published articles and papers on risk analysis, product

safety and public health, He has been a member of the

Highway Safety Study of the Strategic Transportation Research

Committee of the Transportation Research Board of the

3 National Research Council. He was a member of the NHSTA

: Motor Vehicle Safety Research Advisory Committee of the U.S.

Department of Transportation. In 1991 he was elected

president of the Society for Risk Analysis.

Ra) BASES h ee sah aattth niente

NATHAN R. HURT is a recent Past President of the American

Society of Mechanical Engineers. He is vice president of IDM

‘ Environmental Corp. Previously, he worked for Los Alamos

Technical Associates and the Goodyear Tire and Rubber

i Company. He was president of the Goodyear Atomic

Corporation, a subsidiary of Goodyear Tire. He is a

mechanical engineer with 50 years of experience in the chemical

and nuclear industries. His chemical industry experience

includes design, construction and plant management -- primarily

in vinyl monomers and copolymers, synthetic rubbers and

resins, and polyesters. His nuclear industry experience consists

of project management, facilities management, and marketing

in uranium enrichment and weapons plants.

a Cea Ratner tes TR ae ie

DANIEL M. KAMMEN is an environmental physicist and

researcher. He is Professor of Energy Policy at the University

of California at Berkeley. Previously he was Assistant Professor

of Public and International Affairs at Princeton University. He

is the author or contributor to over 40 articles on renewable

energy, technology policy and economic development.

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A. ALAN MOGHISSI is President of the Institute for

Regulatory Science, a non-profit organization dedicated to the

idea that socictal decisions must be based on the best available

scientific information. The activities of the Institute include

research, scientific assessment, and science education at all

levels. Dr. Moghissi held positions at the U.S. Public Health

Service and the U.S. Environmental Protection Agency (EPA).

He served in a number of capacities at EPA, including Director

of the Bioenvironmental/Radiological Research Division,

Principal Science Advisor for Radiation and Hazardous

Materials and Manager of the Health and Environmental Risk

Analysis Program. After his retirement from the EPA, Dr.

Moghissi joined the University of Maryland at Baltimore as

Assistant Vice President for Environmental Health and Safety;

subsequently he was Associate Vice President for

Environmental Health and Safety at Temple University in

Philadelphia, Pennsylvania. - Dr. Moghissi’s research has

included measurement of pollutants and the biological effects

of environmental agents. He is the editor-in-chief of

Environment International and of Technology: Journal of The

Franklin Institute, which is one of America’s oldest continuously

published journals of science and technology. Dr. Moghissi is

chairman of the Environmental Division of the American

Society of Mechanical Engineers.

RODNEY NICHOLS is President and chief executive officer of

the New York Academy of Sciences. He has been a member

of the Executive Committee of the Carnegie Commission on

Science, Technology and Government and was the principal

author of the Commission's report "Science and Technology in

U.S. International Affairs” (1992).

FREDERICK SEITZ is President Emeritus of The Rockefeller

University, a leading research institution. He has been awarded

30 honorary degrees from such institutions as Princeton

University, Northwestern, University of Michigan, Brown, NYU

and University of Pennsylvania. He has received numerous

awards for his work as a scientist and educator including the

A-4

National Medal of Science, the Franklin Medal, the

Department of Defense Distinguished Service Award, the

Nassau Distinguished Service Award and the American College

of Physicians Edward R. Loveland Memorial Award.. He

served two terms as president of the National Academy of

Sciences and has been Chairman of the Board of the Sloan-

Kettering Institute for Cancer Research.

JAMES D. WILSON is Senior Fellow at Resources for the

Future. He holds a Ph.D. in organic chemistry. He has been

a member of numerous scholarly organizations and panels,

including the National Academy of Sciences Committee on Risk

Characterization, the United States Environmental Protection

Agency Peer Review Panel on "Carcinogen Risk Assessment

Guidelines Revision," the United Nations FAO/WHO Joint

Expert Committee on Food Additives. He is a Fellow of the

Society for Risk Analysis.

RICHARD WILSON is Mallinckrodt Professor Emeritus of

Physics at Harvard University and immediate past Director of

the Regional Center for Global Environmental Change at

Harvard University. He is an Affiliate of the Center for

Science and International Affairs and the Center for Middle

Eastern Studies at Harvard University. He is a past Chairman

of the Department of Physics at Harvard University, a past

chairman and currently a member of the Cyclotron Operating

Committee. He is a founder of the Society for Risk Analysis.

He is and has been a consultant to the United States

government and the governments of numerous foreign countries

on matters of nuclear safety, toxicology, epidemiology, public

health and safety and risk assessment. He is the author of

many articles on high energy physics, environmental pollution

and risk analysis, including several articles with the Petitioner.

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CHARLES O. VELZY is a consultant in the field of waste

treatment and disposal. He has over 35 years of experience as

an environmental engineering consultant specializing in the

analysis of waste management problems, design of wastewater

treatment and waste disposal systems and design of new, retrofit

of existing, testing, and permitting of waste combustion

facilities. He has authored or co-authored over 80 publications

— primarily in the field of solid waste management. He has

served on the Science Advisory Board of the USS.

Environmental Protection Agency. He is a past President of

the American Society of Mechanical Engineers (ASME); and

he was Treasurer of the American Academy of Environmental

Engineers (AAEE). He has served on numerous committees

of the ASME, the AAEE, the American National Standards

Institute, and the American Society for Testing and Materials.

He is a registered professional engineer in New York and

eleven other states. Charles Velzy received B.S. degrees in

Mechanical and Civil Engineering and an M.S. in Sanitary

Engineering from the University of Illinois.

ELIZABETH M. WHELAN is President and Founder of the

American Council on Science and Health. She holds a Masters

degree in epidemiology and public health from the Yale School

of Medicine and Harvard School of Public Health, and has a

Doctoral degree in public health from Harvard. She is the

author of more that 20 books about the environment, nutrition

and human health.

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