Petition for Writ of Certiorari — LeFevre v. Brown

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In THE

Supreme Court of the United States

OCTOBER TERM, 1995

JENNIE R. LEFEVRE, SALLY M. HILL,

FREDERICK L. RADA AND MARY CHRISTINA VELDMAN,

‘ Petitioners,

SECRETARY, DEPARTMENT OF VETERANS AFFAIRS,

Respondent.

Petition for a Writ of Certiorari to the

United States Court of Appeals

for the Federal Circuit

PETITION FOR A WRIT OF CERTIORARI

DAVID F. ADDLESTONE REX E. LEE *

BARTON F.. STICHMAN CARTER G. PHILLIPS

GERSHON M. RATNER RONALD S. FLAGG

NATIONAL VETERANS LEGAL KIM FORDE-MAZEUI

SERVICES PROGRAM SIDLEY & AUSTIN

2001 S Street, N.W. 1722 Eye Street, N.W.

Suite 610 Washington, D.C. 20006

Washington, D.C. 20009 (202) 736-8000

(202) 265-8305

Counsel for Petitioners

February 12, 1996 * Counsel of Record

WILSON - Epes PRINTING Co., Inc. - 789-0096 - WASHINGTON, D.C. 20001

QUESTIONS PRESENTED

The Agent Orange Act of 1991 requires the Secretary

of Veterans Affairs, in deciding eligibility for veterans’

disability and death benefits, to consider “sound medical

and scientific evidence” in determining whether a “posi-

tive association” exists between “the exposure of humans

to an herbicide agent” and “the occurrence of a disease

in humans,” 38 U.S.C. § 1116(b)(1) (emphasis added).

The questions presented in this case are:

1. Whether, once the Federal Circuit determined that

the Secretary of Veterans Affairs’ denial of a positive as-

sociation and presumptive service connection for prostate

cancer rested on findings not supported by, and contrary

to, the record, the court should have vacated the Secre-

tary’s rule and remanded the case for reconsideration

rather than upholding the Secretary’s rule on bases not

relied on by the Secretary.

2. Whether the Act permits the Secretary to ignore

credible evidence of an association between exposure to

dioxin, which is indisputably an “herbicide agent,” and

disease in humans simply because dioxin is not, in and

of itself, an herbicide.

(i)

TABLE OF CONTENTS

Page

QUESTIONS PRESENTED owe ccccceccceeeeee i

TABLE OF AUTHORITIES ......... aided eilibesidlacapacecadehdictads iv

Nessun tmeenn, 1

sith 2

STATUTORY AND REGULATORY PROVISIONS

Sh Ee aA ee ee 2

STATEMENT OF THE CASE ............... i roslialeladscaaninlinse 2

a. Prostate Cancer ........................... SS cn YD eR 8

b. Nasal/Nasopharyngeal Cancer ......... 9

c. Hepatobiliary Cancer ..................................... 10

REASONS FOR GRANTING THE PETITION ..__. 12

ae a 30

(iil)

TABLE OF AUTHORITIES

CASES Page

Action, Inc. V. Donovan, 789 F.2d 1453 (10th Cir.

1: REA SARC as URI Sea D aI gral AME APRS 23

Asarco, Inc. V. United States EPA, 616 F.2d 1153

gy ap; BRR RARE entrees MIDI Pe ees 21, 22

Board of Governors of Fed. Reserve Sys. V. Dimen-

sion Fin. Corp., 474 U.S. 361 (1986) aS 29

Brown V. Gardner, 115 S. Ct. 552 (1994) ..... , 28

Camp V. Pitts, 411 U.S. 138 (1973) a taccsisce

Cardinal Chem. Co. v. Morton Int'l, Inc., 113 8. Ct.

WOE, CI otasecce cckviiiname odes 26

Chevron, U.S.A., Inc. Vv. Natural Resources Defense

Council, Inc., 467 U.S. 887 (1984) ............... 29

Cincinnati Bell Tel. Co. v. FCC, 69 F.3d 752 (6th

A |) RRR eee ee eo ee gee eo a 22

Citizens to Preserve Overton Park, Inc. v. Volpe,

401 U.S. 402 (1971). ae 15

Combee v. Brown, 34 F.3d 1039 (Fed. Cir. 1994)... 26

Dole v. United Steelworkers of Am., 494 U.S. 26,

cert. denied sub nom. Associated Builders &

Contractors, Inc. Vv. OSHA, 494 U.S. 1003

Lp ERISA naa Se ee RRA re se orca 28

Facchiano Constr. Co. v. United States Dep’t of

Labor, 987 F.2d 206 (3d Cir.), cert. denied, 114

ee eR | Renee Ee eer eae 22

Feres Vv. United States, 340 U.S. 135 (1950) ; 26

Gilbert Vv. Derwinski, 1 Vet. Apn. 49 (1990) ... 5

Madison Gas & Elec. Co. v. United States EPA, 25

[pM By: Bk. |) BGS ee een RCA ene 22

Mayo V. Schiltgen, 921 F.2d 177 (8th Cir. 1990) K 22

Motor Vehicle Mfrs. Ass’n of the U.S., Ine. V.

State Farm Mut. Auto. Ins. Co., 463 U.S. 29

(1983) .. ad eee a ee oe

Nehmer V. United States Veterans’ Admin., 712

FP. Bem. TEOE CID. Cae. TD. oacnccnveccccncncesecccccsnes 4

OXY USA, Inc. Vv. FERC, 64 F.3d 679 (D.C. Cir.

IR aa eRe SRA i a Ne OW eR ; 22

Pennzoil Co. V. FERC, 789 F.2d 1128 (5th Cir.

| END DONE Nena An AT VEN =U oo CO ep 22

Puerto Rico Sun Oil Co. v. United States EPA, 8

F.3d 78 (ist Cir. 1998) ............. Bsa aN Ee ee 22

TABLE OF AUTHORITIES—Continued

Page \

SEC v. Chenery Corp., 318 U.S. 80 (1948)

ge Eee aidainica ini 15, 19, 20, 21

SEC v. Chenery Corp., 332 U.S. 194 (1947)

fe, Eg PP i ae: 12, 15, 19, 21

Sealed Air Corp. Vv. United States ITC, 645 F.2d

PEO: Cede ii CRE idnee nea edt ca ee 20, 21

South Corp. v. United States, 690 F.2d 1368 (Fed.

ON SUE oa ee er 20

St. James Hosp. v. Heckler, 760 F.2d 1460 (7th

Cir.), cert. denied, 474 U.S. 902 (1985) .............. 17

Stencel Aero Eng’g Corp. v. United States, 431

js 6 UO.) ee ee rs Oe Se 26

Ward v. Merit Sys. Protection Bd., 981 F.2d 521

2 i ee: |. eee oon Pe ET 19, 20

Weyerhauser Co. Vv. Costle, 590 F.2d 1011 (D.C.

Rs MUI, Scat ce ae 17

STATUTORY AND REGULATORY AUTHORITIES

Airing Oe IE io ac ceccnces sa ouinc cocheecelo mrs a aged, 11

i a 15, 29

Se RE ID inci sk deicina ecsnceseccencsaassiicucongacieaaapsin 23

we We tcc ee 11, 23, 26

£45 |) |) ee Cmte 2 Aohes 26

The Agent Orange Act of 1991, Pub. L. No. 102-4,

§ 2, 105 Stat. 11 (1991) (codified as amended at

OS SR ce RC ee 2

ee NE I ac ana bea Bi Ca passim

38 U.S.C.A. § 1116 Note, sec. 3(c) .........00...0000. 6

§ 1116 Note, sec. 3(d) (1) (C) .......... . &2

§ 1116 Note, sec. 3(g) ....................0.0....... 6, 14

§ 1116 Note, sec. 3(i) ..... RS ea eee 14

Oe I aa i i hk 7

The Veterans’ Dioxin and Radiation Exposure

Compensation Standards Act, Pub. L. No. 98-

542, 98 Stat. 2725 (1984) (amended by Pub. L.

No. 102-4, § 10(a), (b), 105 Stat. 19 (1991))_. 4

130 Cong. Rec. S6152 (daily ed. May 22,1984)... 26

130 Cong. Rec. S6156-57 (daily ed. May 22, 1984) .. 26

137 Cong. Rec. H730 (daily ed. Jan. 29,1991)... 4

TABLE OF AUTHORITIES—Continued

Page

137 Cong. Rec. $1267 (daily ed. Jan. 30, 1991) .......... 4

Ca ite te ie ita ieee ahees eee teemacstttnaeaiaveeectinen 7, 26

3 > (eek ike «tte LTC TE PED RPSL 2

Oe Fe, Te ee I iri oo cic veccicteccmeemecnsinananics 8, 24

3 BO KH 5. fa SRST IRE Limes sases 8, 24, 25

56 Fed. Reg. 51,651 (1991) ...........0......... Seabee aii 8, 24

i a _—_ | eaRERNaeaapaecentoe? passim

OTHER AUTHORITIES

1 Kenneth C. Davis, Administrative Law Treatise

4 Bg: Speier: Diam om es cele lie 1 Peale cat ale 25

Michael C.R. Alavanja, et. al., Mortality Among

Forest and Soil Conservationists, 44 Archives

Boerwih, Eleesees De CRO cokmeceetecccatenetbetateoenecieense 9

Leon F. Burmeister, Cancer Mortality in Iowa

Farmers; 1971-1978, 66 J. Nat’] Cancer Inst. 461

¢) | | PRRwanrr ee ER Ye eT 9

David Coggon, et al., Mortality of Workers Ex-

posed to 2 methyl-4-chlorophenoxyacetic acid, 12

Seandinavian J. of Work, Env’t and Health 448

(0). | BARNES RENMEI Semen AE bie. aL NEA ea 10

Marilyn A. Fingerhut, et al., Cancer Mortality in

Workers Exposed to 2,3,7,8-tetrachlorodibenzo-

p-dioxin, 324 New Eng. J. of Medicine 212

CHOOE ences tee 9

Lennart Hardell, et al., Epidemiological Study of

Nasal and Nasopharyngeal Cancer and Their Re-

lation to Phenoxy Acid or Chlorophenol Ex-

posure, 3 Am. J. Indus. Med. 247 (1982) ........... 10

A. Manz, et al., Cancer Mortality Among Workers

in Chemical Plants Contaminated With Dioxin,

338 Lancet O60 (1001) inccnccsceccc le x. 9

Rodolfo Saracci, et al., Cancer Mortality in Work-

ers Exposed to Chlorophenoxy Herbicides and

Chlorophenols, 338 Lancet 1027 (1991) ............... 9,10

Institute of Medicine, National Academy of

Sciences, Veterans and Agent Orange: Health

Effects of Herbicides Used in Vietnam (1998)

(NAD Ree) 3 a Set passim

IN THE

Supreme Court of the United States

OCTOBER TERM, 1995

No. 95———

JENNIE R. LEFEVRE, SALLY M. HILL,

FREDERICK L. RADA AND MARY CHRISTINA VELDMAN,

. Petitioners,

SECRETARY, DEPARTMENT OF VETERANS AFFAIRS,

Respondent,

Petition for a Writ of Certiorari to the

United States Court of Appeals

for the Federal Circuit

PETITION FOR A WRIT OF CERTIORARI

Petitioners Jennie R. LeFevre, Sally M. Hill, Frederick

L. Rada and Mary Christina Veldman respectfully peti-

tion for a writ of certiorari to review the judgment and

opinion of the United States Court cf Appeals for the

Federal Circuit (“Federal Circuit”).

OPINIONS BELOW

The opinion of the Federal Circuit (App. 1a-27a),'

entered on September 15, 1995, is reported at 66 F.3d

1191 (Fed. Cir. 1995). The administrative rule under

review (App. 28a-45a), issued by the Secretary of Vet-

erans Affairs, is reported at 59 Fed. Reg. 341 (1994).

——_

1 All citations to “App. ” refer to the Appendix filed con-

temporaneously herewith pursuant to United States Supreme Court

Rule 14(1) (i). All citations to “Jt. App. ——” refer to the Joint

Appendix filed in the proceedings before the Federal Circuit.

JURISDICTION

The judgment of the Federal Circuit was entered on

September 15, 1995. App. la-27a. A petition for rehear-

ing was denied on October 13, 1995. App. 46a. On

December 12, 1995, the Chief Justice extended the time

for filing this petition to and including February 12,

1996. The jurisdiction of this Court is invoked under

28 U.S.C. § 1254(1).

STATUTORY AND

REGULATORY PROVISIONS INVOLVED

The Agent Orange Act of 1991, Pub. L. No. 102-4, § 2,

105 Stat. 11 (1991) (codified as amended at 38 U.S.C.

$1116) (including relevant portions of the Historical

and Statutory Notes thereto); and the administrative rule

under review, reported at 59 Fed. Reg. 341 (1994),

are reprinted in the Appendix beginning at App. 47a and

28a, respectively.

STATEMENT OF THE CASE

1. The four petitioners are a Vietnam veteran who

has prostate cancer* and three widows of Vietnam vet-

erans who died from hepatobiliary (liver and bile) cancer

or nasal/nasopharyngeal (“nasal”) cancer.’ Petitioners

2 Petitioner Frederick Rada currently suffers from prostate

cancer. He has applied to the Department of Veterans Affairs

(“VA”) for disability benefits for such cancer, but his claim will

presumably be denied because of the denial by the Secretary of

Veterans Affairs (“Secretary”) of presumptive service connection

for prostate cancer in the January 4, 1994 rule at issue herein.

’ Petitioners Jennie LeFevre and Sally Hill are the widows of

veterans who died from hepatobiliary cancer or complications

related thereto. Under current veterans law, a surviving spouse

is entitled to Dependency and Indemnity Compensation (‘DIC’’)

if his or her spouse dies as a result of a service connected

condition. 38 C.F.R. §3.5. Both petitioners have applied to the

VA for DIC benefits based on their spouses’ death from hepatobili-

ary cancer. Petitioner LeFevre’s claim for DIC has already been

denied because of the Secretary’s denial of presumptive service

connection for hepatobiliary cancer. Petitioner Hill’s DIC claim

ew See,

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———— =

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allege that the veterans’ cancers were associated with

exposure to herbicide agents during their military service

in Vietnam and that, accordingly, they are entitled to

disability or death benefits from the Department of Vet-

erans Affairs (“VA”). Under Section 2 of the Agent

Orange Act of 1991, 38 U.S.C. § 1116 (the “Agent Orange

Act” or “Act”), the Secretary of Veterans Affairs (“Sec-

retary”) is required to grant presumptive service connec-

tion for diseases for which he determines there is a “posi-

tive association” between the diseases and exposure to an

“herbicide agent,” i.e., any chemical in an herbicide used

in Vietnam. 38 U.S.C. § 1116(a)(4), (b)(1). This case

involves the petitioners’ challenge to the Secretary’s rule,

issued January 4, 1994, denying a positive association

and presumptive service connection for prostate cancer,

hepatobiliary cancer, and nasal cancer.

2. The Agent Orange Act represents the second at-

tempt by Congress to ensure compensation for Vietnam

veterans and their families for harm suffered as a result

of the veterans’ exposure to dioxin contained in herbi-

cides, including principally “Agent Orange,” * during their

military service in Vietnam. Within the last ten years,

Congress has twice enacted major statutes to compel the

Secretary (formerly Administrator) of Veterans Affairs

to (1) determine which diseases are associated with ex-

posure to dioxin and other chemical agents found in

presumably will be denied likewise because of the Secretary’s denial

of presumptive service connection for hepatobiliary cancer.

Petitioner Mary Christina Veldman’s husband died from nasa!

cancer or complications related thereto. She applied for DIC bene-

fits based on her spouse’s death from nasal cancer. Her claim was

denied by the Regional Office and is pending on appeal before the

Board of Veterans’ Appeals. Her claim presumably will be denied

because of the Secretary’s denial of presumptive service connection

for nasal cancer.

*“Agent Orange” is a 50/50 blend of 2,4-Dichlorophenoxyacetic

Acid (2,4-D) and 2,4,5-Trichlorophenoxyacetic Acid (2,4,5-T). The

chemical processes of making 2,4,5-T created some amount of 2,3,7,8-

Tetrachlorodibenzo-p-dioxin (‘dioxin’).

herbicides used by American military forces in Vietnam;

and (2) to pay compensation to Vietnam veterans or

their survivors for disabilities associated with those

diseases.

First, in 1984, Congress enacted the Veterans’ Dioxin

and Radiation Exposure Compensation Standards Act,

Pub. L. No. 98-542, 98 Stat. 2725, 2727 (1984)

(amended by Pub. L. No. 102-4, § 10(a), (b), 105 Stat.

19 (1991)), which directed the Secretary to grant pre-

sumptive service connection “to veterans who were ex-

posed during service . . . in the Republic of Vietnam to a

herbicide containing dioxin” for any disease which “sound

scientific and medical evidence” demonstrates is “con-

nected . . . to such service.” The VA construed the 1984

statutory standard as demanding proof of a “ ‘cause and

effect relationship between dioxin exposure’ and any dis-

eases,” Nehmer v. United States Veterans’ Admin., 712

F. Supp. 1404, 1416 (N.D. Cal. 1989) (quoting 35

C.F.R. § 3.311(d)), before VA was required to presump-

tively connect such a disease to military service. Under

the VA’s restrictive causal relationship requirement, VA

found only one disease to be service connectable—

chloracne. /d. at 1408. In 1989, the VA’s “cause and

effect” requirement was judicially invalidated. See id. at

1423. Instead, it was held that Congress intended to

require only that there be “a finding of a significant

Statistical association between dioxin exposure and vari-

ous diseases” to mandate presumptive service connection.

Id. at 1420.

In 1991, frustrated with the VA’s restrictive and dila-

tory implementation of even this less burdensome, “statis-

tically significant association” standard, Congress enacted

the Agent Orange Act with an explicitly more permissive

legal standard. See 137 Cong. Rec. H730 (daily ed.

Jan. 29, 1991) (statement of Rep. Evans); 137 Cong.

Rec. $1267 (daily ed. Jan. 30, 1991) (statement of

Sen. Daschle). In the Agent Orange Act, 38 U.S.C.

§ 1116(b), Congress not only omitted any requirement

to prove a “cause and effect” relationship as a prerequi-

site to making a disease presumptively service connected.

but also eliminated the requirement announced by

Nehmer to prove a statistically significant association.°

Instead, by requiring the Secretary to service connect a

disease for which he finds a “positive association,” id.

§ 1116(b)(1), and deeming a “positive association” to

exist whenever “the credible evidence for the association

is equal to or outweighs the credible evidence against

the association,” id. § 1116(b)(3) (emphasis added ),

Congress created a strikingly expansive standard for

Service connection. Congress has not even required that

a “preponderance” of the scientific evidence favor an

association; rather, as in baseball, where a “tie goes to

the runner”, here, a “tie” in the scientific evidence “goes

to the veterans.” Cf. Gilbert v. Derwinski, 1 Vet. App.

49, 55-56 (1990).° Indeed, Congress went so far as to

continue benefits for veterans and their survivors awarded

on the basis of presumptive service connection. even if

the Secretary subsequently determines that a presumption

is not warranted. See 38 U.S.C. § 1116(d).

Under the Agent Orange Act, Congress established a

Statutory scheme pursuant to which the Secretary was to

seek to contract with the National Academy of Science

(“NAS”), an independent non-profit, non-governmental

scientific organization. NAS was to “review .. . and

assess the strength” of the scientific evidence as to the

association, if any, between exposure to herbicides used

® While the Agent Orange Act requires the Secretary to “take

into consideration” when he “evaluate[s] any study” whether its

“results are statistically significant,” 38 U.S.C. § 1116 (b) (2), along

with several other factors affecting how much weight he should

give to any study, id., there is no statutory prerequisite that evi-

dence be statistically significant before presumptive service con-

nection is warranted. /d. §$1116(b). The Secretary apparently

agrees that, under the Act, “statistical significance” is only one

factor affecting the weight to be given a study. See 59 Fed. Reg.

341, 342 (1994) (App. 30a).

® This is in keeping with the congressional recognition of the

large debt which the country owes its veterans. See Gilbert, 1

Vet. App. at 54.

by American forces in Vietnam and “each disease sus-

pected to be associated with such exposure,” 38 U.S.C.A.

§ 1116 Note, sec. 3(c), and submit periodic reports to

Congress on its findings, id., sec. 3(g).

Within 60 days after the Secretary received the NAS’s

first such report, he was to determine whether a “positive

association exist{ed] between (A) the exposure of

humans to an herbicide agent, and (B) the occurrence

of a disease in humans.” 38 U.S.C. § 1116(b)(1) (em-

phasis added).* The Secretary had to find that a “positive

association” existed “if the credible evidence for the asso-

ciation is equal to or outweighs the credible evidence

against the association.” Jd. § 1116(b)(3). Whenever

the Secretary found a “positive association,” the Act re-

quired him to presumptively service connect that disease.

Id. § 1116(b)(1).* However, if the Secretary determined

7 Curiously, the language of the Act only obligates NAS to con-

sider evidence of association between “herbicides” and disease, not

between “herbicide agents” and disease, 38 U.S.C.A. § 1116 Note,

sec. 3(d)(1)(C), as is required of the Secretary under 38

U.S.C. §1116(b) (1). Notwithstanding this apparent discrepancy

between the duties imposed upon NAS and the Secretary, NAS

construed its mandate under the Act as being to study “the health

effects of exposure to Agent Orange, other herbicides used in

Vietnam, and their components, including dioxin.” Jt. App. 106B

(emphasis added). Accordingly, NAS reported on studies concern-

ing exposure both to “herbicides and herbicide components.” Jd.

at 106D (emphasis added). NAS traced the Act to “public concerns”

over, inter alia, “environmental and occupational exposure to herbi-

cides and dioxin.” Jd. at 106A. NAS also noted that studies

involving exposure to herbicides were not as available as studies

involving exposure to TCDD or dioxin. Id. at 106C.

8 The legal effect of granting presumptive service connection for

any particular disease was to presume each Vietnam veteran who

had such disease to have been exposed to an herbicide containing

dioxin in Vietnam, 38 U.S.C. § 1116(a) (3), and to presume that

the disease was “incurred in or aggravated by [military] service,”

id. §$1116(a)(1). As a result of these presumptions, each

Vietnam veteran who incurred such a disease would be entitled to

monthly disability compensation, unless the VA could prove that the

disease was due to some cause other than exposure in Vietnam to

that the scientific evidence weighed against a “positive

association” as to a particular disease, the Act mandated

that he publish within 60 days of this determination a

notice in the Federal Register explaining the “scientific

basis for that determination.” Jd. § 1116(c)(1)(B).

3. On July 27, 1993, NAS issued its first report pur-

suant to the Act—Institute of Medicine, National Acad-

emy of Sciences, Veterans and Agent Orange: Health

Effects of Herbicides Used in Vietnam (Certified List

(“C.L.”) #2) (“NAS Report”) (Jt. App. 106-227).

The NAS Report placed various diseases in one of four

categories relating to the strength of the evidence of an

association between each disease and herbicide exposure.

The four categories are “Sufficient Evidence of an Asso-

ciation,” “Limited/Suggestive Evidence of an Associa-

tion,” “Inadequate/Insufficient Evidence to Determine

Whether an Association Exists,” and “Limited ‘Suggestive

Evidence of No Association.” Jt. App. 204. Prostate

cancer was placed in the second category, “Limited /Sug-

gestive Evidence of an Association,” and hepatobiliary

and nasal cancer were placed in the third category, “In-

adequate/Insufficient Evidence to Determine Whether an

Association Exists.” ®

an herbicide containing dioxin. See id. $1110; 38 C.F.R. § 3.308.

In addition, if such a veteran died from his presumptively service

connected disease, his survivors would be entitled to death benefits.

See 38 U.S.C. § 1810.

* These two categories are defined as follows:

Limited/Suggestive Evidence of an Association: Evidence is

suggestive of an association between herbicides and the out-

come but is limited because chance, bias, and confounding

could not be ruled out with confidence. For example, at least

one high-quality study shows a positive association, but the

results of other studies are inconsistent.

Inadequate/Insufficient Evidence to Determine Whether an

Association Exists: The available studies are of insufficient

quality, consistency, or statistical power to permit a conclusion

regarding the presence or absence of an association. For

example, studies fail to control for confounding, have inade-

quate exposure assessment, or fail to address latency.

Jt. App. 204.

4. On December 22. 1993, the Secretary signed a

rule concluding that the scientific evidence did not estab-

lish a “positive association” as to 20 suspected diseases,

purported to explain the scientific bases for those con-

clusions, and refused to grant presumptive service con-

nection to any of those diseases. On January 4, 1994,

pursuant to 38 U.S.C. § 1116(c)(1)(B), the Secretary

published the rule in the Federal Register. 59 Fed. Reg.

341 (1994) (App. 28a). The rule, which is the subject

of this case, contains the Secretary’s determination that

there is no “positive association,” 38 U.S.C. § 1116(b)

(3), between herbicide exposure” and 20 diseases

suspected of being associated with exposure to herbicides

in Vietnam, and his consequent determination that “a

presumption of service connection is not warranted,” id.

§ 1116(c)(1)(B). Three of the 20 denied diseases—

prostate cancer, hepatobiliary cancer and nasal cancer—

are at issue here.

a. Prostate Cancer

The Secretary found “that the credible evidence against

arn. association between prostate cancer and herbicide ex-

posure outweighs the credible evidence for such an asso-

ciation, and . . . [that] a positive association does not

exist.” 59 Fed. Reg. at 342 (App. 32a). Notably,

prostate cancer is the only disease which NAS placed in

the second category (“Limited/Suggestive Evidence of an

Association”) for which the Secretary denied a positive

association. The other two diseases in that category,

respiratory cancer and multiple myeloma, as well as all

five diseases placed by NAS in the first category, were

granted presumptive service connection. See Jt. App.

106F-106G; 55 Fed. Reg. 43,123, 43,124 (1990)

(non-Hodgkin’s lymphoma, “NHL”); 56 Fed. Reg.

51,651 (1991) (soft tissue sarcoma, “STS”); 56 Fed.

Reg. 29,719, 29,723 (1991).

10 Notwithstanding the statutory mandate that the Secretary

must determine the existence of a “positive association” between

exposure to an “herbicide agent” and disease, the Secretary uni-

formly made his determinations instead based on exposure to an

“herbicide” itself. See 59 Fed. Reg. at 342-46 (App. 30a-45a).

The central basis for the Secretary’s conclusion is his

finding that “[t]here are statistically significant occupa-

tional studies which show no association between prostate

cancer and herbicide exposure.” 59 Fed. Reg. at 342

(App. 31a). In support of this finding, the Secretary

cited three studies reviewed in the NAS Report—studies

by Fingerhut, Manz and Saracci." Jd. The Secretary

balanced the purported conclusions of these three studies

against those of “[s]ome occupational studies [that] have

shown a slight elevated risk for prostate cancer among

farm and forestry workers,” * and “one study concerning

a small sub-set of farmers (Morrison, H., [et al.], 1993.

Farming and prostate cancer mortality. American Jour-

nal of Epidemiology 137:270-280 [C.L. #1.38]) [that]

associated the increased risk of prostate cancer among

farmers specifically with herbicide exposure.” Id. (App.

31a-32a). The only other reason the Secretary gave for

concluding that the “credible evidence against an associa-

tion between prostate cancer and herbicide exposure out-

weighs the credible evidence for such an association,”

id. (App. 32a), was that “[t]he Morrison study is so

recent that it it [sic] too early to determine whether its

results will be replicated by other research,” id.

b. Nasal/Nasopharyngeal Cancer

The Secretary’s first reason for denying “positive asso-

ciation” between herbicide exposure and nasal cancer was

that “[m]ost studies (e.g., [Kerstin Wiklund, Swedish

11 Marilyn A. Fingerhut, et al., Cancer Mortality in Workers

Exposed to 2,3,7,8-tetrachlorodibenzo-p-dioxin, 324 New Eng. J.

of Medicine 212 (1991) (“Fingerhut 1991, C.L. # 1.24”); A. Manz,

et al., Cancer Mortality Among Workers in Chemical Plants Con-

taminated With Dioxin, 338 Lancet 959 (1991) (“Manz 1991,

C.L. #1.36”) ; Rodolfo Saracci, et al., Cancer Mortality in Workers

Exposed to Chlorophenoxy Herbicides and Chlorophenols, 338

Lancet 1027 (1991) (“Saracci 1991, C.L. #1.47”).

Leon F. Burmeister, Cancer Mortality in Iowa Farmers:

1971-1978, 66 J. Nat'l Cancer Inst. 461 (1981) (“Burmeister 1978,

C.L. #1.71”); Michael C.R. Alavanja, et al., Mortality Among

Forest and Soil Conservationists, 44 Archives Envtl. Health 94

(1989).

Agricultural Workers: A Group With a Decreased Risk

of Cancer, 51 Cancer 566 (1983) (“Wiklund 1983, C.L.

# 1.53”); Guglielmo Ronco, et al., Cancer Risk Among

Danish and Italian Farmers, 49 British J. of Indus. Medi-

cine 220 (“Ronco 1992, C.L. #1.46”)]) showed incon-

clusive results, and often did not control for confounding

variables.” Jd. at 345 (App. 43a). The only other rea-

son the Secretary gave for denying positive association

was that, even though three other studies (two of which

the Secretary found were “based on the same three

cases”) “showed increased risk associated with herbicide

exposure; . . . that risk was not statistically significant,

which diminishes the importance of these studies.” Jd. at

345-46 (App. 43a).”

c. Hepatobiliary Cancer

With regard to hepatobiliary (liver and bile) cancer,

the Secretary found:

There are a variety of risk factors that should be

considered by a credible study, including hepatitis B

and C, alcohol abuse, cirrhosis, exposure to poly-

chlorinated biphenyl (PCB), and smoking. The rele-

vant studies are few, and have not adequately con-

trolled for these risk factors. A Swedish case control

study (Hardell L., [et al.], 1984. Aetiological as-

pects on primary liver cancer with special regard to

alcohol, organic solvents and acute intermittent por-

phyria: an epidemiological investigation. British

Journal of Cancer 50:389-397 [C.L. #1.28]) showed

a relationship between herbicide exposure and the sub-

sequent development of hepatobiliary cancer, how-

ever other studies of similar size [Ronco 1992, C.L.

#1.46; Wiklund 1983, C.L. #1.53] indicated no

13 The three studies referred to by the Secretary were: David

Coggon, et al., Mortality of Workers Exposed to 2 methyl-4-

chlorophenoryacetic acid, 12 Scandinavian J. of Work, Env’t and

Health 448 (1986) (“Coggon 1986, C.L. #1.21”); Saracci 1991,

C.L. #1.47; and Lennart Hardell, et al., Epidemiological Study of

Nasal and Nasopharyngeal Cancer and Their Relation to Phenoxy

Acid or Chlorophenol Exposure, 3 Am. J. Indus. Med. 247 (1982)

(“Hardell 1982, C.L. #1.27”).

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relationship. A large occupational study (Fingerhut

et al., 1991, [C.L. #1.24]) and a study of farmers

in Denmark and Italy [the same Ronco 1992 study

already relied on in the prior sentence] found no rela-

tionship. Accordingly, the Secretary has found that

the credible evidence against an association between

hepatobiliary cancer and herbicide exposure out-

weighs the credible evidence for such an association,

and he has determined that a positive association does

not exist.

Id. at 343 (App. 33a-34a).

5. Petitioners sought review in the Federal Circuit

of the Secretary’s rule denying a positive association and

presumptive service connection as to the three diseases."

With respect to prostate cancer, the court first set forth

the Secretary’s findings, most notably:

There are statistically significant occupational studies

which show no association between prostate cancer

and herbicide exposure (e.g., Fingerhut . . .; Manz

— oun s

App. 20a (quoting 59 Fed. Reg. at 342). The court

concluded that the Secretary:

14 As a threshold matter, the Federal Circuit determined, over

the Secretary’s objection, that the court had jurisdiction pursuant

to 38 U.S.C. § 502, which provides that “[a]n action of the Secre-

tary to which [5 U.S.C.] section 552(a)(1) ... refers... is

subject to judicial review. Such review shall be in accordance

with [the Administrative Procedure Act] and may be sought only

in the United States Court of Appeals for the Federal Circuit.”

App. 9a. Section 552(a)(1)(E) requires agencies to publish in

the Federal Register, “substantive rules of general applicability

. and statements of general policy or interpretations of general

applicability ... .” The court recognized that it “may directly

review rules promulgated by the Department of Veteran’s Affairs,

including substantive rules of general applicability, statements of

general policy and interpretations of general applicability.” App.

9a-10a. The court concluded that the Secretary’s determination

was a “rule,” and therefore subject to judicial review, because it was

legislative and policy-making in nature in that it “prescribed the

basis on which the Department would adjudicate every claim seek-

ing disability or survivor benefits for specified diseases allegedly

caused by exposure to herbicides in Vietnam.” Z/d. at 10a.

erred in citing the Fingerhut, Manz, and Saracci

studies as supporting the statement that “[t]here are

statistically significant occupational studies which

show no association between prostate cancer and

herbicide exposure.” Instead, the three studies actu-

ally show a positive association, but are not statisti-

cally significant.

Id. at 2la (emphasis added). Nonetheless, the court

upheld the Secretary’s conclusion as to prostate cancer

because “{i]t would have been accurately supported if

the Secretary had cited to the Ronco and Wiklund stu-

dies, which were statistically significant and showed a

negative association and none at all, respectively.” /d.

(emphasis added).

With respect to hepatobiliary cancer and nasal cancer,

the court determined that the Secretary’s finding of no

positive association was not arbitrary and capricious. In

so doing, the court rejected petitioners’ contention that

it was error on the part of the Secretary to fail to con-

sider undisputed evidence of “biologic plausibility,” i.e.,

biological support for an association between exposure

to dioxin, a contaminart contained in herbicides, and

both hepatobiliary and nasal cancers. Jt. App. 211, 214.

Although the court found that NAS “reported extensive

evidence that dioxin caused cancer in laboratory ani-

mals,” App. 20a, and that “the carcinogenicity of an

herbicide contaminant [e.g., dioxin] could be viewed as

credible evidence of a positive association,” id., the court

upheld the Secretary’s failure to consider indisputably

sound scientific evidence of biologic plausibility between

dioxin and both hepatobiliary and nasal cancers because

“the presence of dioxin in an herbicide does not compel

the conclusion that there was such a relationship caused

by exposure to the herbicide.” /d.

REASONS FOR GRANTING THE PETITION

In SEC v. Chenery Corp., 332 U.S. 194, 196 (1947)

(Chenery II), this Court affirmed the fundamental prin-

ciple of administrative law that “a reviewing court. . .

must judge the propriety of [agency] action solely by the

grounds invoked by the agency.” (Emphasis added).

Adherence to this principle is necessary to ensure the

proper separation of power between the judiciary and

the administrative agencies of the Executive to which

Congress has delegated exclusive authority to administer

various statutory schemes. See id. The Federal Circuit’s

approach to review of agency decisions, as exemplified

by its decision upholding the Secretary’s denial of a posi-

tive association for prostate cancer based on evidence not

relied on by the Secretary, undermines this critical

balance.

The Federal Circuit has shown a willingness—in this

and other cases—to depart from the Chenery doctrine by

conducting its own review of the administrative record

and substituting its judgment for that of the agency. The

Federal Circuit’s approach: (1) unduly intrudes into the

domain of the political branches, (2) conflicts with the

mandates of this Court, and (3) conflicts with the ap-

proaches employed in other circuits. A litigant seeking

judicial review in the D.C. Circuit (as well as in other

circuits) can expect the court to assess the propriety of

the challenged agency action strictly on the bases relied

upon by the agency. By contrast, a litigant traveling

down the street and seeking judicial review in the Fed-

eral Circuit can now expect that court to substitute its

own policy judgments where those rendered by the agency

are unquestionably contrary to the evidence on which the

agency relied.

This case is an especially good vehicle for clarifying

the proper approach to judicial review of agency deci-

sions. The substitution of the Federal Circuit’s judgment

for that of the agency is clear on the face of the court’s

opinion. In addition, given the strength of the evidence

supporting a positive association for prostate cancer, the

Secretary could well reach a different conclusion upon

reconsideration. Furthermore, Congress’s longstanding

concerns—expressed in two legislative acts within the last

decade—that veterans be compensated for harms asso-

ciated with exposure to herbicides contzining dioxin in

Vietnam, coupled with the Federal Circuit’s exclusive

jurisdiction over the Secretary’s decision in this case,

underscore the fact that this case raises important ques-

tions of federal law which should be settled by this

Court.

With respect to hepatobiliary and nasal cancer, the

Federal Circuit misconstrued the Agent Orange Act in

permitting the Secretary to disregard evidence of the

health effects of exposure to a contaminant contained in

herbicides simply because the contaminant is not, in and

of itself, an herbicide. This interpretation contravenes

the Act’s mandate to consider evidence of an association

between “the exposure of humans to an herbicide agent”

and “the occurrence of a disease in humans,” 38 U.S.C.

§ 1116(b)(1) (emphasis added). The court’s construc-

tion unduly restricts the type of evidence on which the

Secretary is to base his determinations, contrary to the

plain language of the Act. Were the Secretary to recon-

sider his determinations with reference to the previously

ignored biological evidence in favor of association, again

he might well find the statutory “positive association”

standard met.

Both of the errors in the Federal Circuit’s decision—

the court’s approach to judicial review and statutory in-

terpretation—render untold numbers of Vietnam veterans

without relief in frustration of Congress’s policy of com-

pensating those who have incurred harm in service of

their country. Moreover, without proper guidance from

this Court, the Secretary will likely repeat the errors left

uncorrected by the Federal Circuit in the four or five

future rounds of determinations required by the Agent

Orange Act. See 38 U.S.C.A. § 1116 Note, sec. 3(g)

(NAS to submit additional reports at least once every

two years after first report); 38 U.S.C. § 1116(b)(2)

(Secretary to make determinations based on the reports re-

ceived from NAS under the Act); 38 U.S.C.A. § 1116(e)

& Note, sec. 3(i) (Secretary’s duty to make positive-

association determinations shall cease ten years after year

of first NAS report). For these reasons, this Court should

review the decision of the Federal Circuit.

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1. “It is well-established that an agency’s action must

be upheld, if at all, on the basis articulated by the agency

itself.” Motor Vehicle Mfrs. Ass’n of the U.S., Inc. v.

State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 50 (1983)

(“Motor Vehicle’) (citations omitted). See also SEC v.

Chenery Corp., 318 U.S. 80, 93-94 (1943) (“Chenery I’’)

(An agency’s “action must be measured by what the

[agency] did, not by what it might have done.”). As this

Court explained in Chenery IT:

a reviewing court . . . must judge the propriety of

[agency] action solely by the grounds invoked by the

agency. If those grounds are inadequate or improper,

the court is powerless to affirm the administrative

action by substituting what it considers to be a more

adequate or proper basis. To do so would propel the

court into the domain which Congress has set aside

exclusively for the administrative agency.

332 U.S. at 196 (emphasis added). Accordingly, no court

is “empowered to substitute its judgment for that of the

agency,” Citizens to Preserve Overton Park v. Volpe, 401

U.S. 402, 416 (1971) (“Overton Park’), but only to

decide whether the agency’s decision is “arbitrary, capri-

cious, an abuse of discretion, or otherwise not in accord-

ance with law,” 5 U.S.C. § 706(2)(A). If the agency

decision is “arbitrary and capricious,” the court must

vacate the decision and remand for further proceedings.

See, e.g., Motor Vehicle, 463 U.S. at 57; Camp v. Pitts,

411 U.S. 138, 143 (1973): Chenery I, 318 U.S. at 95.

M An agency decision is “arbitrary, capricious [or| an abuse

of discretion” under 5 U.S.C. §706(2)(A) if any of the four

following conditions is met: (1) the decision relies on factual

determinations which are unsupported by, or contrary to, the

record, e.g., Motor Vehicle, 463 U.S. at 43, 52-53; (2) the decision

fails to consider relevant factors, e.g., Overton Park, 401 U.S. at

416; Motor Vehicle, 463 U.S. at 43; (8) the decision relies on

irrelevant factors, id.; and/or (4) the agency’s reasoning contains

a “clear error of judgment,” e.g., Overton Park, 401 U.S. at 416;

Motor Vehicle, 463 U.S. at 43.

The Secretary’s decision denying a “positive association”

between prostrate cancer and herbicide exposure is indis-

putably unsupported by the grounds on which the Secre-

tary relied. The Secretary’s entire assessment of whether

the “credible evidence” in favor of association equals or

outweighs the “credible evidence” against begins, and rests

heavily on, his reliance on three specific studies, which

purportedly demonstrate that “[t]here are statistically sig-

nificant occupational studies which show no association

between prostrate cancer and herbicide exposure.” 59

Fed. Reg. 341, 342 (1994) (App. 3la). This critical

finding is not only unsupported by, but contrary to, the

very evidence cited by the Secretary. Those three studies

—Fingerhut, Manz, and Saracci—stand for exactly the

opposite principle from that for which the Secretary cites

them: although not “statistically significant,” they do show

an association. Indeed, now the Secretary “concedes” this

fact. See Secretary’s Br. to Fed. Cir. at 36 (Oct. 14,

1994).

When that prop for the Secretary’s analysis is knocked

out, because it is contrary to the record, the assessment

of the evidence is radically changed in the opposite direc-

tion. Now, instead of three statistically significant studies

showing no association, as the Secretary improperly found,

there are three credible studies all showing a harmful

association, the very opposite of the Secretary’s premise.

Thus, at this first stage of the Secretary’s analysis, what

the record shows is three credible studies in favor of an

association. Next, the Secretary acknowledges that other

occupational studies show a “slight elevated risk for pros-

tate cancer among farm and forestry workers.” 59 Fed.

Reg. at 342 (App. 3la). Then, the Secretary admits

that there is one study, Morrison, which has “associated

the increased risk of prostate cancer among farmers spe-

cifically with herbicide exposure.” Id. (App. 31la-32a)

(emphasis added). Thus, all the studies cited by the

Secretary support an association for prostate cancer.

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The Secretary’s failure to cite a single study in support

of his conclusion that the credible evidence “against” out-

weighed the credible evidence “for” an association, while

citing several studies contrary to this conclusion, is a classic

example of “arbitrariness” under the Administrative Pro-

cedure Act. See Motor Vehicle, 463 U.S. at 43 (explana-

tion “counter to the evidence before the agency” is “arbi-

trary and capricious”); accord St. James Hosp. v. Heckler,

760 F.2d 1460, 1468 (7th Cir.) (reliance on study “seri-

ously undermin[ing]” agency’s conclusions as sole factual

basis for rule is “clear error of judgment”), cert. denied,

474 U.S. 902 (1985); see also Weyerhauser Co. Vv.

Costle, 590 F.2d 1011, 1029-31 & n.22 (D.C. Cir. 1978).

Nor is this harmless error. Since a court “cannot be sure

that under the correct [facts the Secretary] would have

reached the same conclusion, [it] cannot characterize the

defect as harmless.” /d. at 1031 n.27.

On review, the Federal Circuit recognized the error in

the Secretary’s interpretation of the evidence when it ex-

pressly found that the Secretary:

erred in citing the Fingerhut, Manz, and Saracci

studies as supporting the statement that “[t]here are

Statistically significant occupational studies which

show no association between prostate cancer and

herbicide exposure.” Instead, the three studies actu-

ally show a positive association, but are not statisti-

cally significant.

App. 2la (emphasis added). Thus, it is undisputed that

the Secretary “offered an explanation for [his] decision

that runs counter to the evidence before the agency.”

Motor Vehicle, 463 U.S. at 43. Such action is “[nJormally

. arbitrary and capricious.” Jd. That should have

ended the court’s analysis and justified a remand to the

Secretary.

However, the Federal Circuit sought to cure the Secre-

tary’s erroneous reliance on the three specific studies by

searching the record on its own to find two other studies—

which the Secretary never cited—to support his “finding”

of statistically significant studies showing no association.

The court reasoned that the Secretary's finding “would

have been accurately supported if [he] had cited to the

Ronco and Wicklund studies.” App. 2la. On its face,

the court’s substituting other studies for the ones the Secre-

tary actually relied on runs afoul of the fundamental prin-

ciple that “an agency’s action must be upheld, if at ail,

on the hasis articulated by the agency itself.” Motor

Vehicle, 463 U.S. at 50. Since the agency has “offered

an explanation for its decision that runs counter to the

evidence before [it] . . . [t]he reviewing court [may] not

attempt itself to make up for such deficiencies.” Jd. at 43.

The Federal Circuit could not properly speculate how

the Secretary would have decided “positive association”

for prostate cancer if he had known that all of the three

studies he misread as showing “no association” in fact

showed the very opposite: a “positive association.” The

Agent Orange Act places responsibility, in the first and

last instance, with the Secretary to weigh the evidence and

determine whether a positive association exists. See 38

U.S.C. § 1116(b)(1) (“Whenever the Secretary deter-

mines, on the basis of sound medical and scientific evi-

dence, that a positive association exists . . .”) (emphasis

added); id. § 1116(b)(2) (“In making determinations

., the Secretary shall take into account (A) [NAS]

reports .. . and (B) all other sound medical and scien-

tific information and analyses available to the Secretary.

In evaluating any study . . ., the Secretary shall take

into consideration” factors bearing on the weight to be

given the study) (emphasis added). The Secretary him-

self concedes and explains at length that it is his duty

to weigh the evidence to determine whether there is a

“positive association” for any disease. See 59 Fed. Reg.

at 342 (App. 29a). Thus, only the Secretary is properly

situated to reconsider his decision in light of the errone-

ousness of the factual premises for his previous decision.

Under the precedents of this Court, the Secretary’s deci-

sion on prostate cancer should be vacated and the case

remanded to the Secretary for further consideration. See,

. rit well Th

e.g., Motor Vehicle, 463 U.S. at 57; Camp v. Pitts, 411

U.S. 138, 143 (1973); Chenery I, 318 U.S. at 95.

2. The Federal Circuit’s willingness to substitute its

judgment for that of an agency has revealed itself in other

cases as well. In Ward v. Merit Systems Protection Board,

981 F.2d 521 (Fed. Cir. 1992), the Federal Circuit ex-

pressly acknowledged that it was upholding an agency’s

decision under a different theory than that applied by the

agency. The court distinguished Chenery / stating that,

notwithstanding Chenery I’s “broad statements with re-

spect to the basis of judicial review of an administrative

decision,” the case only requires that agency actions not

be upheld on “entirely different” grounds. Ward, 981 F.2d

at 527 (emphasis added). The theory applied by the court

in Ward, although different from the agency’s, the court

reasoned, was permissible because it was not “wholly

different” and it was clear that the agency would have

reached the same conclusion under the court’s new theory.

The Ward court’s reasoning was flawed. First, the

Chenery doctrine does not only preclude courts from

affirming agency actions on “wholly” or “entirely” differ-

ent grounds, it precludes affirmance on any basis if the

agency’s action, viewed solely on the grounds articulated

by the agencv, is improper. See Chenery II, 332 US. at

196; accord Motor Vehicle, 463 U.S. at 43, 50. The

court’s attempt to justify upholding the agency’s decision

because the court believed the agency would reach the

same conclusion is precisely the type of second-guessing

the Chenery doctrine prohibits. Indeed, the risk inherent

in predicting what the agency would have done had it

applied a proper basis for its action is aptly illustrated by

the Ward decision. Contrary to the court’s reasoning, it

is far from clear that the agency would have reached the

same conclusion under the theory supplied by the court.’®

16 The Merit Systems Protection Board had determined that a

federal employee was not covered by the Whistleblower Protection

Act for complaining about the travel expenses of another emp'oyee

on the ground that the travel expenses of a single individual simply

Even more remarkable, in Sealed Air Corp. v. United

States ITC, 645 F.2d 976 (C.C.P.A. 1981), the Federal

Circuit’s predecessor’ purported to be required by

Chenery I to uphold an agency’s decision that the court

found was based on a “mistaken” belief. According to

the court, “[an agency’s] decision must be affirmed where

the result is correct, notwithstanding its reliance on a

wrong ground or a wrong reason.” /d. at 986 (citing

Chenery I, 318 U.S. at 88). The court fundamentally

misread this Court’s discussion in Chenery I.

After reiterating the principle that “[t]he grounds upon

which an administrative order must be judged are those

upon which the record discloses that its action was

based,” Chenery I, 318 U.S. at 87, the Court observed:

In confining our review to a judgment upon the

validity of the grounds upon which the Commission

itself based its action, we do not disturb the settled

rule that, in reviewing the decision of a lower court,

it must be affirmed if the result is correct “although

cannot constitute “a gross waste of funds.” Ward v. Merit Sys.

Protection Bd., 981 F.2d 521, 527 (Fed. Cir. 1992). The court

disagreed, concluding that one person’s travel expenses may amount

to a gross waste of funds under certain circumstances. Jd. at 528.

The court upheld the agency action, however, because on the facts

of the case, in the court’s opinion, the travel expenses did not

reach that level. The court reasoned that since it was purportedly

applying to the particular facts a “narrower” formulation of the

same “general rules” applied by the agency, it was clear that the

agency would have reached the same conclusion under the court’s

theory. Jd. at 527-28.

This reasoning is illogical. The agency denied relief because it

was laboring under the mistaken belief that, as a rule, travel ex-

penses by one individual can never constitute a gross waste of

funds. If, however, the agency understood that the question called

for a particularized factual determination, it might have found

that a gross waste of funds had occurred.

17 The United States Court of Customs and Patent Appeals pre-

ceded the creation of the Federal Circuit and its decisions, rendered

prior to and including September 30, 1982, are binding precedent

in the Federal Circuit. See South Corp. v. United States, 690 F.2d

1368, 1369-70 (Fed. Cir. 1982) (en banc).

Pee eM ee ek ee eT

ich ah a> 9 86 vaten nc

the lower court relied upon a wrong ground or gave

a wrong reason.”

Id. at 88 (quoting Helvering v. Gowran, 302 U.S. 238,

245 (1937)) (emphasis added). The Court in Chenery

I was merely explaining that the proscription against a

court’s substituting its judgment for that of| an adminis-

trative agency is different from the equally well-settled

principle that a reviewing court should affirm a judicial

decision if sustainable on any legal theory. Accordingly,

as the dissent in Sealed Air Corp. recognized, “| Chenery

I], relied upon by the majority, prohibits rather than

endorses the substitution of the court’s findings to sustain

the {International Trade Commission’s] order below.”

645 F.2d at 990 (Nies, J., dissenting) (emphasis added) ;

see also id. at 997 (“No support can be found in Chenery

[1] or Helvering for this court to uphold an order by

interjecting a new ground, sua sponte... .”).

Thus, the decision by the Federal Circuit in the instant

case is not an aberration; instead it represents the Fed-

eral Circuit’s practice of upholding agency decisions on

grounds not relied on by the agency. Through its ap-

proach of “affirm[ing] the administrative action by sub-

stituting what it considers to be a more adequate or

proper basis,” the Federal Circuit has wrongfully “pro-

pel{led] the court into the domain which Congress has

set aside exclusively for the administrative agency.”

Chenery II, 332 U.S. at 196. Accordingly, the Court

should grant this petition.

3. Not only does the Federal Circuit’s approach to

reviewing agency actions flout this Court’s precedent, it

creates an intolerable conflict between the Federal Circuit

and other circuits. When agency decisions are reviewed

in these other circuits, agencies are entitled to reconsider

their rules if initial decisions were erroneous. For ex-

ample, in Asarco, Inc. v. United States EPA, 616 F.2d

1153 (9th Cir. 1980), the Ninth Circuit vacated an

order by the Environmental Protection Agency because

it could not be supported by the grounds relied on by the

agency. In so doing, the court criticized the trial court

for conducting a de novo review of the evidence relating

to the agency’s action:

Consideration of the evidence to determine the cor-

rectness or wisdom of the agency’s decision is not

permitted, even if the court has also examined the

administrative record. If the court determines that

the agency’s course of inquiry was insufficient or in-

adequate, it should remand the matter to the agency

for further consideration and not compensate for the

agency’s dereliction by undertaking its own inquiry

into the merits.

Id. at 1160."*

18 Accord Cincinnati Bell Tel. Co. v. FCC, 69 F.3d 752, 758 (6th

Cir. 1995) (finding agency rule unsupported by agency’s reasons

and requiring remand for agency to reconsider since “[wle will

not supply the basis for the agency’s action, but instead rely on

the reasons advanced by the agency in support of the action’’)

(citations omitted) ; OXY USA, Inc. v. FERC, 64 F.3d 679, 693-94

(D.C. Cir. 1995) (noting that alternative reason might support

agency’s order, but remanding because “[i]t is not the reason

that the Commission adopted, however, and we may affirm the

agency only on the grounds upon which it relied in exercising its

power’) (citations omitted); Madison Gas & Elec. Co. v. United

States EPA, 25 F.3d 526, 528 (7th Cir. 1994) (refusing to uphold

agency order on alternative basis proposed by agency’s lawyer

stating that “[w]hether that is a good or a bad ground for the

agency’s decision . . ., it is not a ground that the agency articu-

lated. We are therefore barred by the Chenery doctrine from

upholding its decision on the basis of it.) (citations omitted) ;

Puerto Rico Sun Oil Co. v. United States EPA, 8 F.3d 73, 79 (1st

Cir. 1993) (vacating agency’s order notwithstanding that rationale

might exist to support agency’s action since an “agency’s decision

cannot be supported on reasoning that the agency has not yet

adopted”) (citations omitted); Facchiano Constr. Co. v. United

States Dep’t of Labor, 987 F.2d 206, 215 (3d Cir.) (directing

remand to agency because basis articulated by agency did not

support agency’s action), cert. denied, 114 8. Ct. 80 (1993) ; Mayo

Vv. Schiltgen, 921 F.2d 177, 179 (8th Cir. 1990) (reversing district

court’s affirmance of agency decision on new ground because “a

reviewing court cannot search the record to find other grounds

to support the [agency’s] decision”); Pennzoil Co. v. FERC, 789

F.2d 1128, 1136 & n.21 (5th Cir. 1986) (vacating and remanding

In the Federal Circuit, in contrast, if an agency makes

critical mistakes in formulating rules, the court will usurp

the agency’s discretion and decide for itself whether the

agency’s rules should be upheld on alternative grounds.

In addition to veterans benefits claims, the Federal Circuit

has exclusive jurisdiction to review cases from a number

of administrative agencies in a variety of substantive

areas including military discharge claims; import regula-

tions; civil service disputes, and patent cases.” Accord-

ingly, the flawed approach employed in the Federal

Circuit here adversely affects not only the litigants in

this particular dispute, but litigants nationwide involved

in a wide range of cases falling within the Federal Cir-

cuit’s jurisdiction.

Absent an expressed intent by Congress, which has not

been made, the Federal Circuit does not have greater

discretion in reviewing decisions by agencies within its

jurisdiction than the other federal courts have over agency

actions brought within theirs. Such a conflict in judicial

review is intolerable and should be corrected by this

Court.

4. This case presents an especially compelling case

for this Court to clarify the proper role of the judiciary

in reviewing agency action.

agency order because agency failed to give proper weight to

credibility findings of Administrative Law Judge, and agency’s

decision may be upheld only “on the ground upon which the agency

acted”) (citations omitted); Action, Inc. v. Donovan, 789 F.2d

1453, 1457 (10th Cir. 1986) (refusing to uphold agency decision

where agency failed to give adequate reasons and stating that

“lallthough there may be grounds for [agency’s decision], this

court cannot attribute to the Secretary appropriate reasons for his

decision’”’).

19 Areas of jurisdiction assigned to the Federal Circuit include

appeals from: the Patent and Trademark Office, 28 U.S.C.

§ 1295 (a) (4); the United States International Trade Commission,

28 U.S.C. § 1295(a) (6) ; certain findings of the Secretary of Com-

merce, 28 U.S.C. § 1295(a)(7); the Merit Systems Protection

Board in disputes under the civil service law, 28 U.S.C. § 1295

(a) (9); and certain rule-making by the Secretary of Veterans

Affairs, 38 U.S.C. § 502.

First, it is beyond dispute that the court below upheld

the agency’s rule on bases not relied on by the agency.

As demonstrated above, see supra pp. 8-9, 16-17, central

to the Secretary’s determination that the evidence in the

administrative record against an association between

prostate cancer and herbicide exposure outweighs the evi-

dence supporting an association is the Secretary’s finding

that “[(t]here are statistically significant occupational stu-

dies which show no association between prostate cancer

and herbicide exposure.” 59 Fed. Reg. 341, 342 (1994)

(App. 3la). It is undisputed that the only studies cited

in support of this finding in fact do show an association.

Furthermore, it is clear that the Federal Circuit recog-

nized that, without those studies, the grounds articulated

by the Secretary did not support his finding, concluding

that the finding “would have” been supported only “if”

he had referred to studies he had not mentioned. App.

21a. Thus, the court’s opinion starkly illustrates that the

court upheld the Secretary’s determination concerning

prostate cancer on bases not relied on by the Secretary

and without which the court knew the Secretary’s finding

lacked a foundation.

Second, the evidence supporting a positive association

for prostate cancer is sufficiently weighty that a remand

for reconsideration would not be a useless formality but

reasonably could result in a different outcome now that

the Secretary is aware of the true relevance of the studies

he relied on previously. The NAS Report, on which the

Secretary principally relied, placed prostate cancer in the

second highest category of diseases for which evidence

supported an association with herbicide exposure—“Lim-

ited/Suggestive Evidence of an Association.” See supra

note 9. Prostate cancer is the only disease among the

three diseases placed in this category and the five placed

in the highest category, Jt. App. 106F, 106G, for which

the Secretary did not find a positive association, and ac-

cordingly, did not grant presumptive service connection.

See 55 Fed. Reg. 43,123, 43,124 (1990) (NHL); 56

Fed. Reg. 51,651 (1991) (STS); 56 Fed. Reg. 29,719,

29,723 (1991). Since NAS found the evidence “suggestive”

of an association, and the standard for finding a positive

association requires only that the evidence in favor be at

least “equal to” the evidence against an association, 38

U.S.C. § 1116(b)(3), the Secretary might well find such

an association for prostate cancer, as he did for other

“suggestive” diseases, now that his previous misinterpreta-

tion of the three studies has been corrected. Indeed, since

the Secretary presumably cited only those studies he found

significant, and all the cited studies concerning prostate

cancer support an association with exposure to herbicide

agents, it seems inconceivable that the Secretary would

not find a positive association upon reconsideration.

Third, policy concerns underlying the Agent Orange

Act and its broad impact on a whole class of veterans

demand that the Act be administered according to the

scheme devised by Congress. As discussed above, see

supra pp. 3-7, the Agent Orange Act represents a

continuing effort by Congress to ensure compensation to

veterans exposed to herbicides containing dioxin during

their service in the Vietnam War. That war and the

ensuing controversy over the effects of Agent Orange

have divided this country like few other issues. Resolving

an issue of such controversial and public concern calls

for the exercise of political judgment and policy-making

discretion. Congress has made that judgment in the

Agent Orange Act and enlisted the expertise of the Secre-

tary to carry out Congress’s objectives. The Secretary’s

decision affects not only the petitioners here but all vet-

erans who have suffered from diseases potentially asso-

ciated with exposure to herbicide agents used in support

of military operations in Vietnam. See 1 Kenneth C.

Davis, Administrative Law Treatise § 5.01 (1958).

Finally, without this Court’s intervention, the Secre-

tary’s denial of presumptive service connection effectively

precludes Vietnam veterans with prostate cancer from

seeking relief of any kind. Because veterans or spouses

affected by prostate cancer cannot gain benefits on the

basis of presumptive service connection, they cannot, as

a practical matter, gain any benefits on any basis.”

Moreover, since the Federal Circuit is the only circuit

with jurisdiction to review the Secretary’s rule, see 38

U.S.C. § 502, that court’s determination binds all veterans

nationwide. This Court has recognized that, due to the

Federal Circuit’s exclusive jurisdiction over cetrain sub-

ject matters, its decisions are “a matter of special im-

portance to the entire Nation” justifying review by this

Court. See Cardinal Chem. Co. v. Morton Int'l, Inc.,

113 S. Ct. 1967, 1971 (1993).

Furthermore, due to considerations of sovereign im-

munity and in light of the alternative administrative

scheme created by Congress for compensating veterans, as

illustrated by the Agent Orange Act, veterans are pre-

cluded from pursuing tort actions against the government

for their herbicide agent-related injuries. See Stencel

Aero Eng’g Corp. v. United States, 431 U.S. 666, 672-

73 (1977); Feres v. United States, 340 U.S. 135, 144

(1950). Given the policy concerns underlying the Agent

eee Tee

20 The Secretary argued in the Federal Circuit, Secretary’s Br.

at 22, that his denial of positive association does not preclude

eligibility for benefits because, in theory, an individual can attempt

to prove that his disease was incurred as a result of military

service. See 88 U.S.C. §1113(b); 38 C.F.R. §$3.303(d). The

court properly rejected this argument, observing that in enacting

the scheme for establishing presumptions, Congress recognized

the virtual impossibility of establishing, in an individual case, that

a veteran’s disease is service connected. See App. lla. This recog-

nition is what led Congress to enact the Veterans’ Dioxin and

Radiation Exposure Compensation Standards Act of 1984 and,

subsequently, the Agent Orange Act of 1991. See, e.g., 130 Cong.

Rec. S6156-57 (daily ed. May 22, 1984) (statement of Sen.

Simpson) (“[it] is impossible ... to make any absolute determina-

tion as to cause and effect.”) ; see also 130 Cong. Rec. 86152 (daily

ed. May 22, 1984) (statement of Sen. Specter) ; Combee v. Brown,

34 F.3d 1039, 1041-42 (Fed. Cir. 1994) (discussing difficulty of

proving direct service connection for radiation exposure). Indeed,

petitioners are aware of no case in which direct service connection

has been granted based on exposure to herbicides, and the Secre-

tary has cited none.

Po ae Ke ted int

actin i a

PEA AN ORE

;

Orange Act and its exclusivity as a remedy for herbicide

agent-injured veterans, it is crucial that the proper deci-

sion-maker—the Secretary—be given the opportunity to

perform his function within the administrative scheme

devised by Congress.

Il.

The Federal Circuit’s decision concerning hepatobiliary

cancer and nasal cancer is also erroneous and indepe-

dently justifies review by this Court. The Federal Cir-

cuit acknowledged that NAS “reported extensive evidence

that dioxin caused cancer in laboratory animals.” App.

20a. Further, the court noted that “the carcinogenicity of

an herbicide contaminant [e.g., dioxin] could be viewed as

credible evidence of a positive association.” Jd. However,

the court held, in effect, that the Secretary could ignore in-

disputably sound scientific evidence of a biologically plaus-

ible link between dioxin and both hepatobiliary and nasal

cancers because dioxin is not, in and of itself, an herbi-

cide: “the presence of dioxin in an herbicide does not

compel the conclusion that there was such a relationship

caused by exposure to the herbicide.” /d.

The premise for the court’s rulng appears to have been

that in making “positive association” determinations under

the Agent Orange Act, the Secretary was only legally ob-

ligated to consider sound scientific evidence of associa-

tion between “herbicide exposure” and disease, not such

evidence of association between an “herbicide contamin-

ant,” i.e., dioxin, and disease. Since the NAS Report es-

tablished “biologic plausibility” only between dioxin and

the two cancers, and that did not necessarily imply plausi-

bility between “herbicide exposure” and disease, the court

reasoned, the Secretary had no legal duty to consider bio-

logic plausibility as to dioxin.

The court’s premise is wrong as a matter of law. The

Act’s plain language establishes that the evidence the

Secretary must consider in making determinations as to

“positive association” is exactly what the court permitted

the Secretary to ignore. The Secretary must determine

whether “a positive association exists between (A) the

exposure of humans to an herbicide agent, and (B) the

occurrence of a disease in humans... .” App. 4a (quot-

ing 38 U.S.C. § 1116(b)(1)) (emphasis added). “Herbi-

cide agent” is statutorily defined as “a chemical in an

herbicide used in support of the United States and allied

military operations in the Republic of Vietnam during the

Vietnam era.” 38 U.S.C. § 1116(a)(4). Thus, dioxin is

indisputably an “herbicide agent.”

In short, the statute expressly mandates the Secretary

to consider “sound medical and scientific evidence” of a

positive association between exposure to an “herbicide

agent” (here, dioxin) and “a disease in humans.” (7d.

§ 1116(b)(1). It is undisputed that the evidence of bio-

logic plausibility between dioxin exposure and both hepa-

tobiliary and nasal cancers is “sound . . . scientific evi-

dence.” Further, it is unchallenged that the evidence of

biologic plausibility is evidence supporting a positive as-

sociation between “exposure of humans to an herbicide

agent, and . . . disease in humans” under 38 U.S.C.

§ 1116(b)(1). See NAS Report at 5-16, 5-18 (Jt. App.

197, 199); 38 U.S.C.A. § 1116 Note, sec. 3(d)(1)(C).

And it is beyond cavil that the Secretary, in making deter-

minations as to positive associations, must “take into ac-

count” not only the NAS’s reports but “all other sound

medical and scientific information and analyses available

to the Secretary,” 38 U.S.C. § 1116(b) (2).

Thus, by permitting the Secretary to disregard avail-

able and highly material evidence of biologic plausibility

between dioxin exposure and the two diseases, the court’s

decision violates the plain language of § 1116(b)(2).

See Brown v. Gardner, 115 S. Ct. 552, 557 (1994)

(courts owe no deference to agency’s interpretation of

statute when it “flies against the plain language of the

statutory text”); Dole v. United Steelworkers of Am.,

494 US. 26, 42-43 (declining to defer to agency inter-

pretation where statute clearly expressed congressional in-

tent), cert. denied sub nom. Associated Builders & Con-

tractors, Inc. v. OSHA, 494 U.S. 1003 (1990); Board

of Governors of Fed. Reserve Sys. v. Dimension Fin.

Corp., 474 U.S. 361, 368 (1986) (“The traditional def-

erence courts pay to agency interpretation is not to be

applied to alter the clearly expressed intent of Con-

gress.”); Chevron, U.S.A., Inc. v. Natural Resources De-

fense Council, Inc., 467 U.S. 837, 842-43 (1984) (“If

the intent of Congress is clear, that is the end of the

matter.’’).

This violation is highly prejudicial because the evi-

dence might very well have caused the Secretary to decide

that there is a “positive association” between the two dis-

eases and exposure to “an herbicide agent.” The Secre-

tary’s failure to consider biologic plausibility made the

Seeretary’s denial of positive association for hepatobili-

ary and nasal cancers “arbitrary, capricious, . . . [and]

otherwise not in accordance with the law,” 5 U.S.C. § 706

(2)(A), and the court erred by upholding that denial.

Nor is this conclusion undermined by the Federal Cir-

cuit’s observation that Congress did not explicitly require

the Secretary to consider evidence of biologic plausibility

in making “positive association” determinations. App.

19a. The absence of an explicit mandate does not imply

that the Secretary was not required to consider such evi-

dence. Congress likewise failed to mention expressly any

requirement that the Secretary consider epidemiological

evidence in making those determinations, yet no one could

suggest that the Secretary is, because of the absence of

such language, free to disregard epidemiological studies

in making his “positive association” determinations. Con-

gress plainly did not authorize the Secretary to turn a blind

eye to any of the relevant scientific evidence in making his

“positive association” determination.

There was no need for Congress to list the specific

types of scientific evidence the Secretary had to consider

because Congress gave him a more general directive: he

must consider the NAS’s “reports” and “all other sound

. . . Scientific information and analyses available to

{him],” 38 U.S.C. § 1116(b)(2), relevant to whether

there is an association between exposure to an “herbicide

agent” and “a disease in humans,” id. § 1116(b)(1). As

applied here, that broader legal mandate necessarily re-

quires the Secretary to consider both evidence of “biologic

plausibility” (from toxicological studies) and evidence

from epidemiological studies because both provide “sound

scientific evidence” of positive association between ex-

posure to the herbicide agent dioxin and the two diseases

at issue.

The court’s erroneous endorsement of the Secretary’s

statutory construction essentially guts the mandate of the

Agent Orange Act to base determinations of positive as-

sociation on all relevant available evidence. If allowed to

stand, the court’s ruling will seriously undermine the Act’s

effectiveness.

As a practical matter, the court’s ruling denies relief

to all Vietnam veterans or spouses affected by hepatobil-

iary and nasal cancer. By sanctioning the Secretary’s de-

cision to disregard relevant and credible evidence of the

harmful effects of herbicide agents such as dioxin, the

court has rendered unfairly difficult, if not futile, any at-

tempts to challenge any of the Secretary’s denials of posi-

tive association. In so doing, the Federal Circuit has

frustrated Congress’s policy judgments embodied in the

Agent Orange Act that veterans are entitled to VA com-

pensation for a particular disease if the scientific evidence

in favor of an association between the disease and ex-

posure to an herbicide agent is not outweighed by the

evidence against. This error warrants review by this

Court.

CONCLUSION

For the foregoing reasons, the petition for a writ of

certiorari should be granted.

Respectfully submitted,

DAVID F. ADDLESTONE REX E. LEE *

BARTON F. STICHMAN CARTER G. PHILLIPS

GERSHON M. RATNER RONALD S. FLAGG

NATIONAL VETERANS LEGAL KIM FORDE-MAZRUI

SERVICES PROGRAM SIDLEY & AUSTIN

2001 S Street, N.W. 1722 Eye Street, N.W.

Suite 610 Washington, D.C. 20006

Washington, D.C. 20009 (202) 736-8000

(202) 265-8305

Counsel for Petitioners

February 12, 1996 * Counsel of Record

APPENDICES

Sh ee

uss Eas

AM ees

APPENDIX A

UNITED STATES COURT OF APPEALS

FOR THE FEDERAL CIRCUIT

94-7050

JENNIE R. LEFEVRE, SALLY M. HILL,

FREDERICK L. RADA AND MARY CHRISTINA VELDMAN,

7 Petitioner,

SECRETARY, DEPARTMENT OF VETERANS AFFAIRS,

Respondent.

DECIDED: September 15, 1995

Before RICH, Circuit Judge, FRIEDMAN, Senior Circuit

Judge, and MICHEL, Circuit Judge.

FRIEDMAN, Senior Circuit Judge.

The issue on the merits is the validity of the determi-

nation of the Secretary of Veterans Affairs, pursuant to

the Agent Orange Act of 1991, 38 U.S.C. § 1116 (Supp.

V. 1993 (the 1991 Act), not to create a presumption

that prostate cancer, liver cancer, and nose cancer are

connected to exposure to herbicides in Vietnam, which

would be applied in determining eligibility for disability

and survivor's benefits. The Secretary contends that under

the 1991 Act we do not have jurisdiction to review his

determination. We hold that we have jurisdiction, and

affirm his determination.

A. In 1984, Congress recognized that it would be

virtually impossible to determine on a case-by-case basis

whether exposure to herbicides in Vietnam caused a dis-

ease in a particular veteran. 130 Cong. Rec. 13,159

(remarks of Senator Simpson). It therefore decided to

require the Secretary to create a reject a presumption-of-

service connection for particular diseases, based upon the

statistical probability of such connection, as reflected in

scientific studies of the relationship between those diseases

and exposure to herbicides and the incidence of those

diseases in persons and animals subject to herbicide ex-

posure. /d. at 13,157-59; See Veterans’ Dioxin and Radi-

ation Exposure Compensation Act of 1984, Pub. L. No.

98-542, 98 Stat. 2725 (1984 Act).

By 1991 Congress had concluded that the Secretary's

administration of the 1984 Act had created doubt about

the way the Act was being applied. A Senate Committee

report on the 1991 Act stated:

A number of reviews of the scientific literature on the

effects of exposure to dioxin have been carried out

under contract with VA and published by VA pursu-

ant to the mandate in [the 1984 Act]. .. . General

acceptance of these reviews has been impaired be-

cause of concern that VA may have exerted influence

on their content. Although the Committee does not

share such a concern, it nevertheless recognizes that

the perception of a possibility of some taint does

exist and cannot be dismissed out of hand. Other

than these reviews, the Committee is unaware of any

other unified analysis of the results obtained from

studies on the effects of dioxin exposure or of any

up-to-date analysis.

S. Rep. No. 101-82, 101st Cong., Ist Sess. 41 (1989).

Congress therefore enacted the 1991 Act to provide

a review, by an entity completely independent of VA,

that will yield unified compilation and analysis of

the results from the various scientific studies.

ST * by BS TCT RED OB 5 eh Ria TE OG Se ee |

In order to accomplish this result, the Committee

bill would provide for an independent contract scien-

tific organization—the National Academy of Sciences

unless NAS is unwilling to undertake this effort—

to undertake a comprehensive review and evaluation

of all of the scientific evidence, literature, and studies

— including the Selected Cancers (SC) Study being

carried out by CDC—pertaining to the adverse health

effects in humans or other animals of exposure to

dioxin and other substances in herbicides used in

Vietnam.

Id. at 42.

The 1991 Act directed the Secretary to seck to enter

into an agreement with the National Academy of Science

(the Academy or NAS), an independent non-profit, non-

governmental scientific organization, under which the

Academy would “review and summarize the scientific

evidence and assess the strength thereof, concerning the

association between exposure to an herbicide used in

support of military operations in Vietnam,” and “each

disease suspected to be associated with such exposure.”

38 U.S.C. § 1116, Note, § 3(c). The agreement was to

require the Academy to transmit to the Secretary written

reports over ten years, the first within 18 months and the

remaining ones at least every two years. /d., Note

§ 3(g) (i).

Under the 1991 Act the Academy is directed, “[flor

each disease reviewed,” to

determine (to the extent that available scientific data

permit meaningful determinations )—

(A) whether a statistical association with herbicide

exposure exists, taking into account the strength of

the scientific evidence and the appropriateness of the

statistical and epidemiological methods used to detect

the association;

(B) the increased risk of the disease among those

exposed to herbicides during service in the Republic

of Vietnam during the Vietnam era; and

anism or other evidence of a causal relationship be-

tween herbicide exposure and the disease.

(2) the Academy shall include in its reports under

subsection (g) a full discussion of the scientific evi-

dence and reasoning that led to its conclusions under

this subsection.

Id., Note § 3(d).

Within 60 days of receiving the Academy’s report, the

Secretary is to determine whether a “positive association

existed between (A) the exposure of humans to an herbi-

cide agent, and (B) the occurrence of a disease in hu-

mans....” 38 U.S.C. § 1116(b)(1). There is such a

positive association “if the credible evidence for the asso-

ciation is equal to or outweighs the credible evidence

against the association.” 38 U.S.C. § 1116(b)(3). If

the Secretary determines, “on the basis of sound medical

and scientific evidence,” that such positive association

exists, he is required to establish a presumption of service

connection for the disease. 38 U.S.C. § 1116(b)(1).

In making his determinations, the Secretary is required

to “take into account” the Academy’s report and “all other

sound medical and scientific information and analysis

available to the Secretary.” 38 U.S.C. § 1116(b)(2).

“In evaluating any study for the purpose of making such

determinations, the Secretary shall take into consideration

whether the results are statistically significant, are capable

of replication, and withstand peer review.” /d.

B. Pursuant to its agreement with the Secretary, the

Academy conducted an extensive investigation in which

it “review[ed] and summarize[d] the strength of the scien-

tific evidence concerning the association between herbicide

exposure during Vietnam service and each disease or con-

dition suspected to be associated with such exposure.”

The result was a 764 page Report, which exhaustively

reviewed the scientific evidence regarding the association

between exposure to herbicides and various diseases. The

Academy made no new studies, but reviewed existing evi-

dence including various epidemiological studies and studies

of biologic plausibility. The latter is biological evidence,

usually from animal testing, that a particular agent is

associated with a particular disease. The Report was

based on the Academy’s review of more than 6000 ab

Stracts of scientific or medical articles, approximately 230

of which were given detailed analysis.

The Academy summarized the extent of the evidence

of association between herbicide exposure and 31 specific

health problems by placing each disease in one of four

categories. The first category, diseases for which the

scientific evidence constituted “Sufficient Evidence of an

Association” “Between Specific Health Problems and Ex-

posure to Herbicides,” contained five diseases, none of

which is at issue inthis case. The second category was:

Limited/Suggestive Evidence of an Association: Evi-

dence is suggestive of an association between herbi-

cides and the outcome but is limited because chance,

bias, and confounding could not be ruled out with

confidence. For example, at least one high-quality

study shows a positive association, but the results of

other studies are inconsistent.

The Report placed three types of cancer in this cate-

gory, one of which, prostate cancer, is at issue here.

The third category was:

Inadequate/Insufficient Evidence to Determine Wheth-

er an Association Exists: The available studies are

insufficient quality, consistency, or statistical power

to permit a conclusion regarding the presence or

absence of an association. For example, studies fail

to control for confounding, have inadequate exposure

assessment, or fail to address latency.

The Report placed 20 diseases in this category. Two

of them—hepatobiliary (liver) and nasa!/nasopharyngeal

(nose) cancer—are at issue here.

The fourth category, “Limited/Suggested Evidence of

No Association,” contains 4 types of cancer. None of

these is here involved.

The Report noted that the Academy “was charged with

reviewing the scientific evidence, rather than making

recommendations regarding DVA policy, and [placement

of the diseases in categories] is not intended to imply or

suggest any policy decisions, which must rest with the

Secretary.”

The Report also considered separately whether exposure

to herbicides increased risk for Vietnam veterans for each

of the diseases. It concluded that “it is not possible for

the Academy to quantify the degree of risk likely to have

been experienced by Vietnam veterans because of their

exposure to herbicides in Vietnam,” “giv[en] the large un-

certainties that remain about the magnitude of potential

risk from exposure to herbicides in the occupational, en-

vironmental! and veterans studies that have been reviewed,

inadequate control for important confounders in these

studies, and the lack of information needed to extrapolate

from the level of exposure in the studies reviewed to that

of individual Vietnam veterans... .” Id.

In assessing the evidence of biologic plausibility, the

Report noted: “Several studies . . . have been performed

in laboratory animals. In general they have produced

negative results, although some were not performed using

rigorous criteria for the study of cancer in animals, and

some produced equivocal results that could be interpreted

as either positive or negative. . . . [T]here is as yet no

convincing evidence of, or mechanistic basis for, the car-

cinogenicity of any of the herbicides used in Vietnam.”

The Report also addressed the chemical compound known

as TCDD or dioxin, which was a contaminant “found in

varying levels in different batches of Agents Orange,

vray pore ee pom

ee ene

Pink, Purple, and Green.” The Academy reported that

there was extensive evidence that dioxin caused cancer

in laboratory animals.

C. Upon receipt of the Academy’s Report, the Secre-

tary announced that he would recognize as service con-

nected the five diseases the Report had placed in the first

category (“Sufficient Evidence of an Association”). The

Department appointed a task force, “an internal, high-

level panel” of experts, “to carefully analyze the report

from a medical/scientific perspective and to solicit com-

ments from representatives of veterans service organiza-

tions and other interested parties.”

In a detailed report to the Secretary, the task force

“attempt[ed] to translate the Academy’s evaluation of the

scientific literature and other available information into

terms compatible with the legal mandate of P.L. 102-4,

i.e. whether the credible evidence for an association be-

tween exposure to herbicides and any specific disease was

equal to or outweighed the credible evidence against an

association. This is not a simple task. The Task Force

also tried to evaluate additional evidence presented by

the veterans service organizations and a recently published

follow-up on the Seveso incident published in Epidemi-

ology.” The task force concluded that the Academy “had

done a thorough review and evaluation of the available

scientific and medical information regarding health effecis

of the exposure to Agent Orange and other herbicides

used during the Vietnam conflict. There were no obvious

gaps in the information sources cited,” and “the approach

taken by the NAS Committee was reasonable and scien-

tifically sound and the organization of the report was

understandable.”

The task force made recommendations based on the

Academy’s conclusions. It endorsed the Secretary’s deci-

sion that the five diseases that the Academy placed in its

first category (“Sufficient Evidence of an Association”)

“also meet the standard for a positive finding under the

statute, i.e., the credible evidence for an association is

equal to or outweighs the credible evidence against an

association.” The task force spent substantial time on the

three types of cancer that the Academy placed in the

second category (“Limited Suggestive Evidence of an

Association”). The task force concluded that two of

those cancers (respiratory cancers and multiple myeloma)

met the statutory standard and recommended the estab-

lishment of a presumption of service connection for them.

It concluded, however, that prostate cancer did not meet

the statutory standard and recommended not establishing

a presumption of service connection for it. The task

force concluded that none of the diseases that the Academy

placed in the third category (“Inadequate/Insufficient Evi-

dence of an Association”), which included liver and nose

cancer, met the statutory standard, and recommended not

to establish a presumption of service connection for them.

The Secretary adopted the task force’s recommenda-

tions, and published a detailed explanation of his decision

in the Federal Register. 59 Fed. Reg. 341-46 (1994).

He explained his reasons for denying a presumption of

service connection for most of the diseases, including the

three here at issue. The Secretary discussed the scientific

reports, both pro and con, upon which he based his deci-

sion. The Secretary requested that the Academy “focus

particularly on the evidence regarding prostate cancer

and peripheral neuropathy in its next review.”

D. The four petitioners are a Vietnam veteran who

has prostate cancer and three widows of Vietnam veterans

who died of liver or nose cancer. They allege that the

veterans’ exposure to herbicides in Vietnam caused the

cancers. The veteran has a claim for disability compen-

sation pending before the Department of Veterans Affairs.

The three widows have pending their claims for depend-

ency and indemnity compensation. The petition for re-

Tne eee

view asserts that the Secretary’s denial of a presumption

for the three types of cancer “will cause the VA immi-

nently to deny their claims for compensation.”

The petition for review challenges the Secretary’s deter-

mination “insofar as it determines not to allow veterans

presumptive service connection, based on herbicide ex-

posure in Vietnam, for prostate cancer, hepatobiliary

cancers and nasal/nasopharyngeal cancer” (emphasis in

original). The petitioners’ brief asserts that the Secretary’s

denial of a “positive association” between those three types

of cancers and exposure to herbicides in Vietnam was

arbitrary, capricious and contrary to law.

Il.

The jurisdiction of this court directly to review acts

of the Secretary is set forth in 38 U.S.C. § 502 (Supp. V.

1993):

An action of the Secretary to which section 552

(a)(1) or 553 of title 5 (or both) refers, other

than an action relating to the adoption or revision

of the schedule of ratings for disabilities under sec-

tion 355 of title 38, is subject to judicial review.

Such review shall be in accordance with [the Admin-

istrative Procedure Act] and may be sought only in

the United States Court of Appeals for the Federal

Circuit.

Section 552(a)(1) requires each agency to publish in

the Federal Register, among other things, “substantive

rules of general applicability . . . and statements of gen-

eral policy or interpretations of general applicability ... .”

Section 553, captioned “Rule making,” specifies the pro-

cedure for rulemaking.

Thus, we may directly review rules promulgated by the

Department of Veteran’s Affairs, including substantive

rules of general applicability, statements of general policy

10a

and interpretations of general applicability because these

are all actions “to which section 552(a)(1) refers... .”

Section 551(4) of title 5 defines a rule as

the whole or part of an agency statement of general

or particular applicability and future effect designed

to implement, interpret, or prescribe law or policy

or describing the organization, procedure, or practice

requirements of an agency.

As our predecessor court explained: “rule making is legis-

lative in nature, is primarily concerned with policy con-

siderations for the future rather than the evaluation of

past conduct, and looks not to the evidentiary facts but to

policy-making conclusions to be drawn from the facts.”

American Express Co. v. United States, 472 F.2d 1050

(C.C.P.A. 1973) (citations omitted) .

These definitions cover the Secretary’s determination

not to establish a presumption-of-service connection with

respect to prostate, liver, and nose cancer and the vet-

eran’s exposure to herbicides in Vietnam, and therefore

we have jurisdiction to review it. The determination was

a rule because it was a “statement of general . . . applica-

bility and future effect designed to implement . . . or pre-

scribe . . . law or policy ... .” It prescribed the basis

on which the Department would adjudicate every claim

seeking disability or survivor benefits for specified diseases

allegedly caused by exposure to herbicides in Vietnam.

It reflects the result of a process that was “legislative in

nature, [was] primarily concerned with policy considera-

tions for the future . . ., and look[ed] . . . to policy-

making conclusions to be drawn from the facts.” Con-

gress delegated to the Secretary the authority to deter-

mine whether or not to create a presumption of service

connection between certain diseases and military service

in Vietnam, and that determination would control the

decisions in all subsequent cases involving the issue.

Deel SAAB vine Bea Roe

lla

The Secretary contends that his determination is not

a substantive rule because it will not have binding effect,

since a claimant may establish service connection for any

disease or injury by showing that it was incurred in serv-

ice. Not only is this position unrealistic, but it is incon-

sistent with the reasons that led Congress in the 1984

Act to adopt the procedure of the Secretary creating pre-

sumptions of service connection for various diseases asso-

ciated with herbicide exposure. Congress did so because

it recognized that ordinarily it would be impossible for

an individual veteran to establish that his disease resulted

from exposure to herbicides in Vietnam.

Relying on the statement in Animal Legal Defense

Fund v. Quigg, 932 F.2d 920, 927 (Fed. Cir. 1991)

that “a rule is substantive when it effects a change in

existing law or policy which affects individual rights and

obligations,” the Secretary contends that his determina-

tion was merely an announcement “that there would be

no change in the existing law and policy regarding service

connection for those diseases” (emphasis in original). The

policy decision that the 1991 Act required the Secretary

to make was whether or not, under the Act’s standards,

to establish a presumption of service connection for var-

ious diseases. The Secretary’s determination not to estab-

lish a presumption for a particular disease was just as

much a change in policy as his determination to establish

a presumption for another disease. Until the Secretary

had acted, there was no existing law regarding presump-

tions for the Department to follow. The Secretary changed

existing law by establishing or refusing to establish a

presumption.

The Supreme Court dealt with a similar issue in Frozen

Food Express v. United States, 351 U.S. 40 (1956).

That case involved the exception in § 203(b)(6) of the

Interstate Commerce Act, 49 Stat. 543 (1935), from

the requirement that motor carriers have certificates of

12a

public convenience and necessity, to carry “agricultural

commodities.”

“After an investigation instituted on its own motion

[which included an evidentiary public hearing], the Com-

mission issued an order that specified commodities are

not ‘agricultural’ within the meaning of § 203(b)(6).”

Id. at 41. The order incorporated findings from an ac-

companying report that “listted] those commodities that

the Commission [found] exempted under § 203(b) (6)

and those that are not.” Jd. at 42. The order did not,

however, direct carriers hauling the commodities declared

non-exempt to comply with the certificate requirement.

Id. at 45 (Harlan, J., dissenting).

Frozen Food Express, a motor carrier that was trans-

porting commodities that the Commission had ruled were

not “agricultural commodities” (and therefore required a

certificate), filed suit before a three-judge district court

challenging the Commission’s ruling. The district court

“dismissed the action, saying that the ‘order’ of the Com-

mission was not subject to judicial review,” id. at 43,

because “the ‘order’ was no more than a report of an

investigation . . . ‘which does not command the carrier

to do, or to refrain from doing anything.’” Jd. (quoting

United States v. L.A.R. Co., 273 U.S. 299 (1927)).

The Supreme Court reversed, holding that the Com-

mission’s action was reviewable. It stated:

The determination by the Commission that a com-

modity is not an exempt agricultural product has an

immediate and practical impact on carriers who are

transporting the commodities, and on shippers as

well. The “order” of the Commission warns every

carrier, who does not have authority from the Com-

mission to transport those commodities, that it does

so at the risk of incurring criminal penalties.

§ 222(a). Where unauthorized operations occur, the

Commission may proceed administratively and issue

a cease and desist order. § 204(c). The determina-

13a

tion made by the Commission is not therefore ab-

Stract, theoretical, or academic. The “order” of the

Commission which classifies commodities as exempt

or nonexempt is, indeed, the basis for carriers in

ordering and arranging their affairs. The “order” of

the Commission is in substance a “declaratory” one,

see 60 Stat. 240, 5 US.C. § 1004(d), which

touches vital interests of carriers and shippers alike

and sets the standard for shaping the manner in

which an important segment of the trucking business

will be done.

Id. at 43-44 (citations omitted).

That reasoning covers the present case. The Secretary’s

determination not to establish a presumption of service

connection for prostate, liver and nose cancers “has an

immediate and practical impact” on Vietnam veterans

and their survivors who claim benefits on the ground that

the veterans’ cancers resulted from exposure to herbicides,

was not “abstract, theoretical, or academic,” “touches

vital interests of” veterans and their survivors, and “sets

the standard for shaping the manner in which an impor-

tant segment” of the Department’s activities “will be

done.”

“[J]udicial review of executive action ‘will not be cut

off unless there is persuasive reason to believe that such

was the purpose of Congress.’” De Martinez vy. Lamagno,

115 S. Ct. 2227, 2231 (1995) (citation omitted). Not

only is there no showing that Congress so intended, but

the few references to the subject in the legislative history

of the 1991 Act support reviewability. During the debate

on the 1991 Act, Senator Daschle stated that

the Secretary’s determination that a particular dis-

ease does not warrant a presumption of service con-

nection would be subject to judicial review. For

example, the Secretary’s published determination that

a presumption of service connection is not warranted

l4a

for a particular disease clearly seems to be a “state-

ment of general policy . . . subject to judicial review

under the Veterans Judicial Review Act.”

137 Cong. Rec. $1271 (daily ed. January 30, 1991).

Senator DeConcini, the floor manager, agreed “that such

a determination would be reviewable.” Jd. Accord 137

Cong. Rec. H731 (daily ed. Jan. 29, 1991) (statement

of Rep. Evans). Moreover, in the 1984 Act, which first

required the Secretary to determine—whether a presump-

tion was warranted, one of the bill’s primary sponsors

Stated:

The Administrator’s compliance with the required

process, as well as any regulations issued by the

Administrator would be subject to judicial review.

I cannot overstate the importance of judicial re-

view. . . It is only just that . . . Vietnam veterans

have their day in court.

130 Cong. Rec. 13,155 (remarks of Senator Specter).

There is a well-settled presumption that agency actions

are reviewable. See McNary v. Haitian Refugee Ctr.,

Inc., 498 U.S. 479, 496 (1991); Wheeler v. United

States, 1t-F:3d 156, 159 (Fed. Cir. 1993). Nothing the

Secretary relies on refutes that presumption. The Secre-

tary’s determination is reviewable.

If.

A. The 1991 Act created an unusual administrative

scheme by which the Secretary is to determine whether

there is a service connection between particular diseases

and herbicide exposure in Vietnam. Unlike the typical

responsibility assigned to government agency, the Secre-

tary was directed to enter into an agreement with the

Academy, a private non-government scientific agency, for

the latter to summarize and assess the scientific evidence

dealing with the issue and report its findings to him.

The major work involved thus was assigned to a non-

ER es a a rn

;

15a

government entity; the Academy was given 18 months

to submit its report, but the Secretary was to render his

decision within 60 days of receiving the report.

Following the receipt of the Academy’s report, and

obviously giving it great weight, the Secretary was to

determine, for each of the diseases involved, whether

there was a “positive association” between exposure of

people to a herbicide agent and the existence of the

disease. The standard for determining whether a positive

association exists is whether the “credible evidence” for

the association equals or outweighs the credible evidence

against it. If the Secretary finds a credible association

for a particular disease, he must establish a presumption

of service connection for it.

The statutory scheme contemplates that the Academy’s

findings on these medical and scientific issues reflected in

the Report would be the key element in the Secretary’s

decision. Congress necessarily intended that the Secre-

tary, although not bound by the Academy’s findings,

would place great reliance on them.

Under the Administrative Procedure Act, we review

the Secretary’s decision to determine whether it was “arbi-

trary, Capricious, an abuse of discretion, or otherwise not

in accordance with law... .” 5 U.S.C. § 706(2)(A).

This is a “highly deferential” standard of review. Ethyl

Corp. v. EPA, 541 F.2d 1, 34 (D.C. Cir.), cert. denied

sub. nom., 426 U.S. 941 (1976). Under the unusual

statutory scheme here involved, with the function of re-

viewing and evaluating the scientific evidence given to a

non-governmental, independent scientific entity, an ex-

tremely strong showing of error would be required before

we properly could reverse the Secretary’s determination.

B. The petitioners make a sweeping attack on the evi-

dentiary basis for the Secretary’s findings and determina-

tions. Although the argument is framed mainly in terms

of the Secretary’s alleged failure to consider the evidence

in the Academy Report that indicated a positive associa-

l6a

tion between the three cancers involved and herbicide

exposure, it really asserts that the Secretary erred because

he did not give sufficient weight to that evidence. In

essence the petitioners urge us to reweigh the evidence

and come to a different conclusion than the Secretary

reached.

Our role, however, “is not to substitute our judgment

for that of the” Secretary. Motor Vehicle Mfrs. Ass'n v.

State Farm Mutual Auto Ins. Co., 463 U.S. 29, 43

(1983). Instead, we consider whether the Secretary has

“examine[d] the relevant facts and articulate[d] an ade-

quate explanation for [his] action including a rational

connection between the facts found and the choice made.

. . . [and] whether the decision was based on a consider-

ation of the relevant factors and whether there has been

a clear error of judgment.” /d. As we show in Part IV,

the Secretary’s decision refusing to establish a presumption

of service connection for the three cancers must stand.

The Secretary did not uncritically accept or merely

rubber-stamp the Academy’s factual findings. Instead, he

carefully reviewed the evidentiary bases for them, recog-

nizing the strengths and weaknesses of the underlying

scientific studies that the Academy discussed. As the

Academy had urged, he did not view the report’s categori-

zation of the diseases according to the strength of statis-

tical association “as recommendations regarding DVA

policy.” Instead of merely applying the presumption to

whole categories, the DVA task force, and then the Secre-

tary, examined each disease to determine if it met the

statutory standard. “The task force spent a great deal

of time focusing on” the diseases in the Academy’s second

category, Limited/Suggestive Evidence of an Association,

and determined that two of those diseases, respiratory

cancers and multiple myeloma met the standard, whereas

prostate cancer did not. The Secretary followed this

recommendation, thus demonstrating independent judg-

ment by recognizing that the Academy’s factual conclu-

17a

sions did not equate to the ultimate decision entrusted

to him.

The petitioners rely to a considerable extent upon two

declarations by experts in biostatistics and toxicology

(Drs. Levin and Legator), which they filed with their

opening brief. Those declarations, however, were not part

of the record on which the Secretary based his decision,

and are not part of the record before this court. Indeed,

this court denied the petitioners’ motion to supplement

the administrative record with those declarations. We

therefore do not consider them.

C. A major ground of the petitioners’ challenge to the

Secretary’s evaluation of the evidence is that the Secretary

improperly failed to recognize that the number of scien-

tific studies showing a positive association between herbi-

cide exposure and each of the three cancers was greater

than the number showing no association or a negative

association. According to the petitioners, the numerical

superiority of this evidence required the Secretary to treat

it as credible evidence of an association. They point out

that the statutory evidentiary standard the Secretary is to

apply in making his findings on whether a positive associ-

ation exists is whether “credible evidence” for an associ-

ation equals or outweighs the credible evidence against it.

The statute does not define “credible evidence.”

In evaluating evidence, however, the critical question

is its quality, not its quantity. Just as “numerical superi-

ority of witnesses alone could not necessarily entitle the

plaintiff to relief,” Banks Construction Company v. United

States, 364 F.2d 357, 362 (Ct. Cl. 1966), so numerical

superiority of scientific studies does not require the trier

of fact to accept them.

The Department task force that reviewed the Academy

Report anticipated and explained the reasons for rejecting

the numerically-superior documents:

it is likely that there will be controversy surrounding

any conclusion about which evidence is credible and

18a

which evidence is less so or not credible. This is

clearly demonstrated by the statements of Mark

Venuti of the National Veterans Legal Services Proj-

ect which have been endorsed by the Vietnam Vet-

erans of America. Many readers of the NAS report

will consider all positive evidence equally “credible”

despite the confidence limits of the studies or the

Statistical significance of the findings. There will be

a tendency to look at the charts prepared by the NAS

and count up those studies which could be interpreted

as positive and balancing them against cited studies

showing no association or a negative association.

This was not the purpose of those charts and the

NAS staff and representatives of the Committee re-

sponsible for the report findings refused to interpret

their findings that way either in the report or in face-

to-face meetings with VA staff or at Congressional

hearings.

The Secretary explained why he rejected the petitioners’

approach:

Simply comparing the number of studies which report

a negative relative risk for a particular condition is

not a valid method for determining whether the

weight of evidence overall supports a finding that

there is or is not a positive association between herbi-

cide exposure and the subsequent development of the

particular condition. Because of difference in statis-

tical significance, confidence levels, control for con-

founding factors, etc., some studies are clearly more

credible than others, and the Secretary has given

them more weight in evaluating the overall credibility

of the evidence concerning specific diseases.

59 F.R. 342.

There is no basis for assuming that, by using the term

“credible evidence” in the 1991 Act, Congress intended

to preclude the Secretary from applying the traditional

principle that the critical issue in evaluating evidence is its

19a

quality, not its quantity. The Secretary cannot be faulted

for refusing to follow the more numerous studies that

support the petitioners’ contentions.

D. The petitioners challenge the Secretary’s refusal to

establish a presumption of service connection for liver

and nose cancer because he did not discuss the biologic

plausibility of an association between those diseases and

herbicide exposure. The 1991 Act provides that “[flor

each disease reviewed, the Academy shall determine...

whether there exists a plausible biological mechanism or

the evidence of a causal relationship between herbicide

exposure and the disease.” 38 U.S.C. § 1116, note d.

Although the Act did not require the Secretary to address

this factor, it required him to consider the Academy report,

which he admittedly did. The petitioners contend that by

implication the Act required him also to discuss biologic

plausibility.

The fact that the 1991 Act expressly required the

Academy to consider biologic plausibility but did not

impose a similar requirement on the Secretary is a strong

indication that the latter was not required to do so. Rus-

sello v. United States, 464 U.S. 16, 23 (1983) (“ ‘[W]here

Congress includes particular language in one section of a

statute but omits it in another section of the same Acct, it

is generally presumed that Congress acts intentionally and

purposely in the disparate inclusion or exclusion’” (cita-

tion omitted) ). This is particularly so because the Act

specified in detail exactly what were the precise duties of

the Academy and the Secretary, and provided specific

standards for each of them to follow. If Congress had

intended the Secretary specifically to consider biologic

plausibility, it is a reasonable assumption that it would

have told him to do so—as it did for the Academy.

The Academy Report discussed biologic plausibility, but

concluded that “there is as yet no convincing evidence of,

or mechanistic basis for, th carcinogenicity of any of the

herbicides used in Vietnam.” The Report also addressed

20a

the carcinogenicity of dioxin, a contaminant “found in

varying levels in different batches of Agents Orange, Pink,

Purple, and Green,” and reported extensive evidence that

dioxin caused cancer in laboratory animals. Although the

carcinogenicity of an herbicide contaminant could be

viewed as credible evidence of a positive association, the

Secretary could reasonably conclude otherwise. This is

especially so because Congress directed that the Academy

was specifically to address “whether there exists a plausible

biological mechanism or other evidence of a causal rela-

tionship between herbicide exposure and the disease,” and

the presence of dioxin in an herbicide does not compel

the conclusion that there was such a relationship caused

by exposure to the herbicide.

IV.

We turn to the Secretary’s refusal to establish a pre-

sumption of service connection for the three cancers

involved.

1. The Secretary stated the following with regard to

prostate cancer:

The NAS report assigns prostate cancer to a category

labeled limited/suggestive evidence of an association,

which it defined as meaning there is evidence sugges-

tive of an association between herbicide exposure

and a particular health outcome, but that evidence

is limited because chance, bias, and confounding

could not be ruled out with confidence. Prostate

cancer is a very common male genitourinary cancer

which shows marked increased prevalence with age.

There are statistically significant occupational studies

which show no association between prostate cancer

and herbicide exposure (e.g., Fingerhut . . . ; Manz

...3 Saracci....). Some occupational studies have

shown a slight elevated risk for prostate cancer among

farm and forestry workers (e.g. Burmeister . . . ;

Alavanja . . .); however, only one study concerning

2la

a small sub-set of farmers (Morrison . . .) associated

the increased risk of prostate cancer among farmers

specifically with herbicide exposure. The Morrison

study is so recent that it is too early to determine

whether its results will be replicated by other research.

Accordingly, the Secretary has found that the credi-

ble evidence against an association between prostate

cancer and herbicide exposure outweighs the credible

evidence for such an association, and he has deter-

mined that a positive association does not exist.

59 F.R. 242 (1994).

The Secretary’s decision accurately analyzes and sum-

marizes the Academy’s findings and is reasonable in light

of that analysis. In placing prostate cancer in the “limited/

suggestive evidence of an association” category, the Acad-

emy pointed out:

Most of the agricultural studies indicate some eleva-

tion in risk of prostate cancer. One large well-done

study in farmers showed an increased risk, and sub-

analyses in this study indicate that the increased risk

is specifically associated with herbicide exposure. The

three major production worker studies . . . all show a

small, but not statistically significant elevation in risk.

It should be noted, however, that most of the

associations are relatively weak (< 1.5).

The petitioners point out, and the Secretary concedes,

that he erred in citing the Fingerhut, Manz, and Saracci

studies as supporting the statement that “[t]here are statis-

tically significant occupational studies which show no asso-

ciation between prostate cancer and herbicide exposure.”

Instead, the three studies actually show a positive associa-

tion, but are not statistically significant. The quoted por-

tion of the statement, however, is not inaccurate. It would

have been accurately supported if the Secretary had cited

to the Ronco and Wicklund studies, which were statis-

tically significant and showed a negative association and

none at all, respectively.

22a

We will “not reverse simply because there are uncer-

tainties, analytical imperfections, or even mistakes in the

pieces of the picture petitioners have chosen to bring to

[our] attention . . . but only when there is such an

absence of overall rational support as to warrant the

description arbitrary and capricious.” Center for Auto

Safety v. Peck, 751 F.2d 1336, 1370 (D.C. Cir. 1985)

(citation omitted). In this case, the Secretary’s miscita-

tion of the three studies does not so undermine the Secre-

tary’s rationale as to render it arbitrary and capricious.

The petitioners also contend that the Secretary erred

in characterizing the Morrison study as a small subset.

The Academy Report shows that the Secretary’s statement

is accurate. His statement referred to a subset of the

study that covered only 20 cases of exposure to herbicides.

The Secretary reasonably could have concluded that be-

cause the entire study covered 1,138 cases of exposure,

this was but a small segment of the study.

The petitioners further object to the Secretary’s state-

ment that it is “too early to determine whether [Morri-

son’s] results will be replicated by other research.” They

contend that this statement indicates that the Secretary

misconstrued his statutory mandate to consider whether

the studies are capable of replication. The Secretary’s

statement merely reflects the Morrison study’s warning

that the results “should be considered tentative because of

the relatively low increases in risk and because an asso-

ciation has not been noted previously.” The Secretary

reasonably recognized that future research on the issue

might undermine or contradict the conclusions of the Mor-

rison study. Indeed, a further Academy report on pros-

tate cancer was due in July 1995.

The petitioners make various arguments concerning the

relative merits of the studies the Academy considered. As

noted, however, it is not our function to reweigh the

evidence. The Secretary’s decision is reasonable based on

Peep oT ee

23a

the Academy’s factual determinations, particularly its find-

ing that almost all studies, certainly all statistically sig-

nificant ones, show a weak positive association at best.

B. The Secretary stated with regard to hepatobiliary

(liver) cancers

The NAS reports assigns . . . hepatobiliary cancers

.. . to a category labeled inadequate/insufficient evi-

dence to determine whether an association exists,

which is defined as meaning that the available studies

are insufficient quality, consistency, or statistical

power to permit a conclusion regarding the presence

or absence of an association with herbicide exposure.

Hepatobiliary cancers are cancers of the liver and

bile duct. There are a variety of risk factors that

should be considered by a credible study, including

hepatitis B and C, alcohol abuse, cirrhosis, exposure

to . . . PCB, and smoking. The relevant studies are

few and have not adequately controlled for these

risk factors. A Swedish case control study (Hardell

.. . 1984...) showed a relationship between herbi-

cide exposure and the subsequent development of

hepatobiliary cancer; however, other studies of sim-

ilar size (Ronco... 1992... .; Wiklund... 1983

. . .) indicated no relationship. A large occupa-

tional study (Fingerhut et al, 1991) and a study of

farmers in Denmark and Italy (Ronco 1992) found

no relationship. Accordingly, the Secretary has

found that the credible evidence against an associa-

tion between hepatobiliary cancer and herbicide ex-

posure outweighs the credible evidence for such an

association, and he has determined that a positive

association does not exist.

59 F.R. 343 (1994).

The Academy Report summarized the various studies

as follows:

24a

There are relatively few occupational, environmental,

or veterans studies of liver cancer (Table 8-6), and

most of these are small in size and have not con-

trolled for life-style-related risk factors. One of the

largest studies (Hardell et al., 1984) indicates an

increased risk for liver cancer and exposure to herbi-

cides, but another study of Swedish agricultural

workers (Wiklund, 1983) estimates a relative risk

that is significantly less than 1.0 [i.e. a protective

association]. The estimated relative risks from other

studies are both positive and negative. As a whole,

given the methodological difficulties associated with

most of the few existing studies, the evidence re-

garding liver cancer is not convincing with regard to

either an association with herbicides/TCDD or the

lack of an association.

The petitioners contend that the Secretary erred in

stating that there were few studies. This statement, how-

ever, reflects the Academy’s statement based on the 18

studies that it examined. The petitioners cite no other

studies that they contend the Secretary also should have

considered.

According to the petitioners, the Secretary erred in

failing to consider that nine studies are in favor of asso-

ciation, that eight are against it and that one finds no

association. Instead, the Secretary relied on the studies

with comparably sized samples, all of which were among

the largest. Of the four he discussed, three do not show

a positive association. Moreover, none of the 18 studies

are Statistically significant. Given this evidence, the Sec-

retary reasonably concluded that the credible evidence

against an association outweighed the credible evidence

for one.

C. The Secretary stated with regard to nasal/naso-

pharyngeal cancer:

ides. “Sas eae

25a

The NAS report assigns . . . nasal/nasopharyngeal

cancer to a category labeled inadequate/insufficient

evidence to determine whether an association exists,

which is defined as meaning that the available studies

are insufficient quality, consistency, or statistical

power to permit a conclusion regarding the presence

or absence of an association with herbicide exposure.

NAS noted an association between nasal cancers

and occupational exposure to nickel and to chro-

mates. Exposure to wood dust is also a risk factor

for nasal cancers; smoking and exposure to formal-

dehyde may increase the risk associated with wood

dust. There is also evidence that leather workers

have an increased risk for nasal cancers and that

there is an association betwen chronic nasal diseases

and consumption of salt preserved foods. Most stud-

ies (e.g. Wiklund, 1983; Ronco et al. 1992)

showed inconclusive results, and often did not con-

trol for confounding variables. Two other epidemi-

ological studies based on the same three cases

(Saracci et al., 1991. Coggon D., Pannett B., Winter

P.D., Achedson E.D., Bonsall J., 1986. Mortality

of workers exposed to 2 methyl-4-chlorophenoxyacetic

acid. Scandinavian Journal of Work, Environment,

and Health 12:448-454) and one case-control study

(Hardell L., Johansson B. Axelson O., 1982. Epi-

demiological study of nasal and nasopharyngeal

cancer and their relation to phenoxy acid or chlor-

ophenol exposure. American Journal of Industrial

Medicine 3 247-257) showed increased risk asso-

ciated with herbicide exposure. However, that risk

was not statistically significant, which diminishes the

importance of these studies. Accordingly, the Secre-

tary has found that the credible evidence against an

association between nasal/nasopharyngeal cancers

and herbicide exposure outweighs the credible evi-

26a

dence for such an association, and he has determined

that a positive association does not exist.

59 F.R. 346 (1994).

The Secretary’s discussion again echoed the Academy’s

Report, which discussed numerous factors and exposures

to things other than herbicides that have been associated

with an increased risk of nasal cancer. It summarized

the epidemiological results much as the Secretary did,

noting that the Saracci and Coggon studies were based

on the same three cases and that the Hardell study “found

[a positive association] for those exposed to phenoxy

acids, based on eight exposed cases.” It noted that a

Center for Disease Control Study of Vietnam veterans

found no “significant associations for Vietnam service,”

and that “[o]ther studies show[ed] inconclusive results.”

It summarized the epidemiologic evidence as “inadequate

or insufficient . . . to determine whether an association

exists between exposure to herbicides and nasal/naso-

pharyngeal cancer.”

Aside from the biologic plausibility and numerical argu-

ments previously discussed, the petitioners contend that

the Secretary made two key errors with regard to nasal

cancers. They contend that the Secretary (as did the

Academy) mistakenly stated that the Sarraci and Coggon

studies were based on the same three cases. Even if this

statement was wrong, however, it did not render the Sec-

retary’s decision arbitrary or capricious. Neither he nor

the Academy attached any significance to the supposedly-

shared samples, but only noted the fact. It does not

appear to have influenced the Secretary’s conclusion. In-

stead, he focused on the inconclusive nature of the studies

discussed, citing their lack of significance.

The petitioners also contend that the Secretary’s deci-

sion was arbitrary and capricious because it did not dis-

cuss a subset of the Hardell study that showed a positive

wer

27a

association between chlorophenol exposure and nasal

cancer. The Secretary’s decision discusses the Hardell

study in terms of what it shows regarding “the risk asso-

ciated with herbicide exposure.” This shows that he was

aware of the Hardell study, but considered only the part

dealing with herbicide exposure. Other than the inclusion

of the subset in a table in the Academy’s report, the peti-

tioners offer no convincing reason why the chlorophenol

subset was a relevant factor that the Secretary should

have deemed credible evidence of a relationship between

herbicide exposure and nasal cancer. They have thus

failed to demonstrate that this was relevant evidence, and

thus the Secretary’s alleged failure to consider it would

not be arbitrary and capricious. Citizens to Preserve

Overton Park v. Volpe, 401 U.S. 402, 416 (1971).

AFFIRMED.

28a

APPENDIX B

[59 Fed. Reg. 341 (Jan. 4, 1994)]

DEPARTMENT OF VETERANS AFFAIRS

Diseases Not Associated With Exposure to

Certain Herbicide Agents

AGENCY: Department of Veterans Affairs.

ACTION: Notice.

SUMMARY: As required by law, the Department of

Veterans Affairs (VA) hereby gives notice that the Sec-

retary of Veterans Affairs, under the authority granted

by the Agent Orange Act of 1991, has determined that a

presumption of service connection based on exposure to

herbicides used in the Republic of Vietnam during the

Vietnam era is not warranted for the following conditions:

Prostate cancer, peripheral neuropathy, hepatobiliary can-

cers, bone cancers, female reproductive cancers, renal can-

cers, testicular cancer, leukemia, abnormal sperm param-

eters and infertility, cognitive and neuropsychiatric

disorders, motor coordination dysfunction, metabolic and

digestive disorders, immune system disorders, circulatory

disorders, respiratory disorders (other than lung cancer),

nasal/nasopharyngeal cancer, skin cancer, gastrointestinal

tumors, bladder cancer, brain tumors, and any other con-

dition for which the Secretary has not specifically deter-

mined a presumption of service connection is warranted.

FOR FURTHER INFORMATION CONTACT: John

Bisset, Jr., Consultant, Regulations Staff, Compensation

and Pension Service, Veterans Benefits Administration,

Department of Veterans Affairs, 810 Vermont Avenue,

NW., Washington, DC 20420, (202) 233-3005.

SUPPLEMENTARY INFORMATION: Section 3 of

the Agent Orange Act of 1991, Public Law 102-4, 105

Stat. 11 (1991), directed the Secretary to enter into an

29a

agreement with the National Academy of Sciences (NAS)

to review the scientific evidence concerning the associa-

tion between exposure to herbicides used in support of

military operations in the Republic of Vietnam during

the Vietnam era and each disease suspected to be asso-

ciated with such exposure. Congress mandated that NAS

determine, to the extent possible, (1) whether there is a

Statistical association between the suspect diseases and

herbicide exposure, taking into account the strength of the

scientific evidence and the appropriateness of the methods

used to detect the association; (2) the increased risk of

disease among individuals exposed to herbicides during

service in the Republic of Vietnam during the Vietnam

era; and (3) whether there is a plausible biological mech-

anism or other evidence of a causal relationship between

herbicide exposure and the suspect disease.

Section 2 of Public Law 102-4 provides that whenever

the Secretary determines, based on sound medical and

scientific evidence, that a positive association (i.e., the

credible evidence for the association is equal to or out-

weighs the credible evidence against the association) exists

between exposure of humans to an herbicide agent (i.e.,

a chemical in an herbicide used in support of the United

States and allied military operations in the Republic of

Vietnam during the Vietnam era) and a disease, the Sec-

retary will publish regulations establishing presumptive

service connection for that disease. If the Secretary deter-

mines that a presumption of service connection is not war-

ranted, he will publish a notice of that determination.

which includes an explanation of the scientific basis for

that determination.

Although Public Law 102-4 does not define “credible”,

it does instruct the Secretary to “take into consideration

whether the results are statistically significant, are capable

of replication, and withstand peer review.” Simply com-

paring the number of studies which report a positive

30a

relative risk to the number of studies which report a nega-

tive relative risk for a particular condition is not a valid

method for determining whether the weight of evidence

overall supports a finding that there is or is not a positive

association between herbicide exposure and the subsequent

development of the particular condition. Because of dif-

ferences in statistical significance, confidence levels, con-

trol for confounding factors, etc., some studies are clearly

more credible than others, and the Secretary has given

them more weight in evaluating the overall credibility of

the evidence concerning specific diseases.

After reviewing approximately 6,420 abstracts of scien-

tific or medical articles and selecting approximately 230

epidemiologic studies for detailed analysis, consulting with

outside experts, and conducting public hearings, NAS is-

sued a report, entitled “Veterans and Agent Orange:

Health Effects of Herbicides Used in Vietnam”, on July

27, 1993. The Secretary announced that same day that

he had concluded that a positive association exists between

exposure to herbicides used in the Republic of Vietnam

and the subsequent development of Hodgkin’s disease and

porphyria cutanea tarda. Proposed regulations were pub-

lished in the Federal Register on September 28, 1993

(See 58 FR 50528-30). The Secretary also announced

that VA would review the remaining findings in the NAS

report to determine whether a positive association exists

between herbicide exposure and any other conditions.

That review has been completed and this notice, pursuant

to Public Law 102-4, conveys the Secretary’s determina-

tion that there is no positive association between herbicide

exposure and prostate cancer, peripheral neuropathy, hep-

atobiliary cancers, bone cancers, female reproductive can-

cers, renal cancers, testicular cancer, leukemia, abnormal

sperm parameters and infertility, cognitive and neuro-

psychiatric disorders, motor/coordination dysfunction,

metabolic and digestive disorders, immune system dis-

orders, circulatory disorders, respiratory disorders (other

3la

than lung cancer), nasal/nasopharyngeal cancer, skin can-

cer, gastrointestinal tumors, bladder cancer, brain tumors,

and any other condition for which the Secretary has not

specifically determined a presumption of service connec-

tion is warranted.

The NAS report assigns prostate cancer to a category

labeled limited/suggestive evidence of an association,

which it defined as meaning there is evidence suggestive

of an association between herbicide exposure and a par-

ticular health outcome, but that evidence is limited be-

cause chance, bias, and confounding could not be ruled

out with confidence. Prostate cancer is a very common

male genitourinary cancer which shows marked increased

prevalence with age. There are statistically significant

occupational studies which show no association between

prostate cancer and herbicide exposure (e.g., Fingerhut

M.A., Halperin W.E., Marlow D.A., Piacitelli L.A., Hon-

char P.A., Sweeney M.H., Greife A.L., Dill P.A., Steen-

land K., Suruda A.J. 1991. Cancer mortality in workers

exposed to 2,3,7,8-tetrachlorodibenzo-p-dioxin. New Eng-

land Journal of Medicine 324:212-218; Manz A., Berger

J., Dwyer J.H., Flesch-Janys D., Nagel S., Waltsgott H.

1991. Cancer mortality among workers in chemical plant

contaminated with dioxin. Lancet 338:959-964; Saracci

R., Kogevinas M., Bertazzi P.A., Bueno De Mesquita

B.H., Coggon D., Green L.M., Kauppinen T., L’Abbe

K.A., Littorin M., Lynge E., Mathews J.D., Neuberger

M., Osman J., Pearce N., Winkelman R. 1991. Cancer

mortality in workers exposed to chlorophenoxy herbicides

and chlorophenois. Lancet 338:1027-1032). Some occu-

pational studies have shown a slight elevated risk for pros-

tate cancer among farm and forestry workers (e.g., Bur-

meister L.F., 1981. Cancer mortality in Iowa farmers:

1971-1978. Journal of the National Cancer Institute

66:461-464; Alavanja M.C., Merkle S., Teske J. Eaton

B., Reed B. 1989. Mortality among forest and soil con-

servationists. Archives of Environmental Health 44:94-

101); however, only one study concerning a small sub-

32a

set of farmers (Morrison H., Savitz, D., Semenciw R.,

Hulka B., Mao Y., Morison D., Wigle D. 1993. Farm-

ing and prostate cancer mortality. American Journal of

Epidemiology 137:270-280) associated the increased risk

of prostate cancer among farmers specifically with herbi-

cide exposure. The Morrison study is so recent that it it

too early to determine whether its results will be repli-

cated by other research. Accordingly, the Secretary has

found that the credible evidence against an association

between prostate cancer and herbicide exposure outweighs

the credible evidence for such an association, and he has

determined that a positive association does not exist.

The NAS report assigns peripheral neuropathy, hepato-

biliary cancers, bone cancers, female reproductive cancers,

renal cancers, testicular cancer, leukemia, abnormal sperm

parameters and infertility, cognitive and neuropsychiatric

disorders, motor coordination dysfunction, metabolic and

digestive disorders, immune system disorders, circulatory

disorders, respiratory disorders (other than lung cancer),

and nasal nasopharyngeal cancer to a category labeled

inadequate insufficient evidence to determine whether an

association exists, which is defined as meaning that the

available studies are of insufficient quality, consistency,

or statistical strength to permit a conclusion regarding

the presence or absence of an association with herbicide

exposure.

Peripheral neuropathy can be induced by many com-

mon medical and environmental disorders unrelated to

herbicide exposure, such as aging, alcoholism, diabetes,

and exposure to other toxic chemicals. The last time VA

considered this issue, it determined, after receiving the

advice of the Veterans’ Advisory Committee on Environ-

mental Hazards, that there was sufficient evidence to meet

the requirements for a “significant statistical association,”

the standard in effect at that time, between exposure to

herbicides containing dioxin and the subsequent develop-

ment of peripheral neuropathy under certain circumstances

as ot ile aah ty

33a

(See 57 FR 2236-38). That conclusion, however, relied

heavily on case reports, which are anecdotal and have no

Statistical significant, and occupational studies such as

Singer and colleagues (1982) (Singer R., Moses M.,

Valciukas J., Lilis R., Selikoff I.J., 1982. Nerve conduc-

tion velocity studies of workers employed in the manu-

facture of phenoxy herbicides. Environmental Research

29:297-311) whose credibility is compromised because

they did not apply consistent methods to define a compari-

son group, determine exposure, evaluate clinical deficits,

use standard definitions of peripheral neuropathy, or

eliminate confounding variables. The Singer study, for

example, excluded individuals with excessive alcohol con-

sumption from the controls but not from the subjects of

the study. Other occupational studies, such as Suskind

and Herzberg (1984) (Suskind R.R., Hertzberg V.S.,

1984. Human health effects of 2,4,5-T and its toxic

contaminants. Journal of the American Medical Associa-

tion 251:2372-2380), which did not have those methodo-

logical problems, showed no difference in the incidence

of peripheral neuropathy for workers exposed to herbi-

cides and workers not so exposed. Accordingly, the Sec-

retary has found that the credible evidence against an

association between peripheral neuropathy and herbicide

exopsure outweighs the credible evidence for such an

association, and he has determined that a positive associ-

ation does not exist.

Hepatobiliary cancers are cancers of the liver and bile

duct. There are a variety of risk factors that should be

considered by a credible study, including hepatitis B and

C, alcohol abuse, cirrhosis, exposure to polychlorinated

biphenyl (PCB), and smoking. The relevant studies are

few, and have not adequately controlled for these risk

factors. A Swedish case control study (Hardell L., Bengts-

son N.O., Jonsson U., Eriksson S., Larsson L.G., 1984.

Aetiological aspects on primary liver cancer with special

regard to alcohol, organic solvents and acute intermittent

porphyria: an epidemiological investigation. British Jour-

34a

nal of Cancer 50:389-397) showed a relationship between

herbicide exposure and the subsequent development of

hepatobiliary cancer; however, other studies of similar

size (Ronco G, Costa G., Lynge E., 1992. Cancer risk

among Danish and Italian farmers. British Journal of

Industrial Medicine 49:220-225; Wiklund K., 1983.

Swedish agricultural workers: a group with a decreased

risk of cancer. Cancer 51:566-568) indicated no rela-

tionship. A large occupational study (Fingerhut et al.,

1991) and a study of farmers in Denmark and Italy

(Ronco et al., 1992) found no relationship. Accordingly,

the Secretary has found that the credible evidence against

an association between hepatobiliary cancer and herbicide

exposure outweighs the credible evidence for such an asso-

ciation, and he has determined that a positive association

does not exist.

Bone cancers were considered together with joint can-

cers by NAS. Because of the rarity of bone cancers,

most studies have been too small to detect a significant

risk. There has not been a consistent finding of bone

cancer in exposed groups; the preponderance of studies

show no association, and the few studies that demon-

Strate a positive relationship (Fingerhut et al., 1991;

Breslin P., Kang H., Lee y., Burt V., Shepard B.M., 1988.

Proportionate mortality study of U.S. Army and USS.

Marine Corps veterans of the Vietnam War. Journal of

Occupational Medicine 30:412-419) are small and have

large confidence intervals which include one. The small

size of the studies and the confidence limitations compro-

mise their significance. Accordingly, the Secretary has

found that the credible evidence against an association

between bone cancers and herbicide exposure outweighs

the credible evidence for such an association, and he has

determined that a positive association does not exist.

Female reproductive cancers reviewed by NAS include

those of the breast, uterus, cervix, ovary, and other genital

malignancies. The data related to women and herbicide

exposure is extremely limited because few of the studies

Oe eee Te

35a

included women. A large number of the breast cancer

studies showed no association. Two studies (Thomas

T.L., Kang H., Dalager N., 1991. Mortality among

women Vietnam veterans, 1973-1987. American Journal

of Epidemiology 134:973-980; Manz et al., 1991) showed

an increased risk for breast cancer which was not signifi-

cant since both studies failed to control for reproductive

histories and had methodological problems. Only one

small case control study (Donna A., Betta P-G., Robutti

F., Crosignani P., Berrino F., Bellingeri D., 1984. Ovari-

an mesothelial tumors and herbicides: a case control

study. Carcinogenesis 5:941-942) showed an association

with ovarian cancer, but the confidence intervals were

very wide. The larger occupational and farm worker

studies all showed significantly lower mortality ratios than

expected. Likewise, studies of exposures generally found

less uterine and cervical cancer than expected. Accord-

ingly, the Secretary has found that the credible evidence

against an association between female reproductive can-

cers and herbicide exposure outweighs the credible evi-

dence for such an association, and he has determined

that a positive association does not exist.

The leather industry, asbestos, cadmium, petroleum

products, analgesics, smoking, and obesity have been as-

sociated with renal cancers. Studies of renal cancer have

generally produced inconclusive results, in some cases

because of failure to adequately control for these con-

founding factors. Only one study of agricultural and

forest workers (Alavanja et al., 1989) showed a signifi-

cantly increased risk of death from renal cancers; how-

ever, the preponderance of studies, including the two larg-

est (Wiklund, 1983; Burmeister, 1981), showed either

no relationship with renal cancers or increased risk which

was not significant. Accordingly, the Secretary has found

that the credible evidence against an association between

renal cancers and herbicide exposure outweighs the credi-

ble evidence for such an association, and he has deter-

mined that a positive association does not exist.

36a

Major risk factors for testicular cancer are undescended

testis and other factors, such as genetic abnormalities,

infections, etc., which produce atrophy and dysfunction.

In general, occupational studies (Ronco et al., 1992;

Wiklund, 1983) have shown no association between herbi-

cide exposure and testicular cancer. Occupational and

environmental studies have found either no association

or increased risk which was not significant. Studies con-

cerning Vietnam veterans were inconsistent, and in those

that found increased risk, that risk was generally not

significant. Accordingly, the Secretary has found that the

credible evidence against an association between testicular

cancer and herbicide exposure outweighs the credible

evidence for such an association, and he has determined

that a positive association does not exist.

Potential evidence for an association between herbicide

exposure and leukemia comes primarily from studies of

farmers (Ronco et al., 1992; Wigle D.T., Semenciw R.B.,

Wilkins K., Riedel D., Ritter L., Morrison H.I., Mao Y.,

1990. Mortality study of Canadian male farm operators:

non-Hodgkin’s lymphoma mortality and agricultural prac-

tices in Saskatchewan. Journal of the National Cancer

Institute 82:575-582) and residents of Seveso, Italy

(Bertazzi P.A., Zocchetti C., Pesatori A.C., Guercilena

S., Sanarico M., Radice L., 1989b. Ten-year mortality

study of the population involved in the Seveso incident in

1976. American Journal of Epidemiology 129:1187-

1200; Bertazzi P.A., Zocchetti C., Pesatori A.C., Guerci-

lena §., Consonni D., Tironi A., Landi M.T., 1992.

Mortality of a young population after accidental exposure

to 2,3,7,8-tetrachlorodibenzodioxin. International Journal

of Epidemiology 21:118-123). The studies of farmers did

not control for other confounding exposures (Brownson

R.C., Reif J.S., Chang J.C., Davis J.R., 1989. Cancer

risk among Missouri farmers. Cancer 64:2381-2385.;

Brown L.M., Blair A., Gibson R., Everett G.D., Cantor

K.P.. Schuman L.M., Burmeister L.F., Van Lier S.F.,

Dick F. 1990. Pesticide exposures and other agricultural

37a

risk factors for leukemia among men in Iowa and Minne-

sota. Cancer Research 50:6585-6591). When farmers

were stratified by suspected herbicide exposure, the inci-

dence of leukemia was generally not elevated. Any eleva-

tion appeared to be due to factors other than herbicide

exposure, e.g., risk was higher among chicken farmers

than wheat farmers (Alavanja M.C., Blair A, Merkle S.,

Teske J. Eaton B., 1988. Mortality among agricultural

extension agents. American Journal of Industrial Medicine

14:167-176). The suggestive evidence of increased risk

concerning Seveso, Italy was not significant because of

the small number of actual cases in which leukemia was

found. Since none of the studies demonstrated a dose-

response for any subtype of leukemia, it is not possible

to attribute leukemia to herbicide exposure. Accordingly,

the Secretary has found that the credible evidence against

an association between leukemia and herbicide exposure

outweighs the credible evidence for such an association,

and he has determined that a positive association does

not exist.

The common parameters used to evaluate toxic effects

to sperm are number, motility, structure, and morphology.

Many chemicals have been implicated in interfering with

motility and sperm structure (Wyrobek A.J., Gordon

L.A., Burkhart J.G., Francis M.W., Kapp R.W., Letz G.,

Malling H.V., Topham J.C., Whorton M.D., 1983. An

evaluation of human sperm as indicators of chemically

induced alterations of spermatogenic function. A report

of the U.S. Environmental Protection Agency Gene-Tox

Program. -Mutation Research 115:73-148). One occupa-

tional study (Lerda D., Rizzi R., 1991. Study of repro-

ductive function in persons occupationally exposed to

2,4-dichlorophenoxyacetic acid (2,4-D). Mutation Re-

search 262:47-50) and one study of Vietnam veterans

(Air Force Health Study (AFHS), 1992. An Epidemi-

ologic Investigation of Health Effects in Air Force Per-

sonnel Following Exposure to Herbicides. Reproductive

Outcomes. Brooks AFB: USAF School of Aerospace

38a

Medicine. AL-TR-992-0900 602 pp.) found no associa-

tion with decreased sperm count. Another study of Viet-

nam veterans (Centers for Disease Control (CDC), 1989.

Comparison of Serum Levels of 2,3,7,8-Tetrachlorodi-

benzo-p-dioxin with Indirect Estimates of Agent Orange

Exposure Among Vietnam Veterans: Final Report. At-

lanta: U.S. Department of Health and Human Services)

found lower sperm concentration and reduced sperm

motility, but suggested these outcomes may be associ-

ated with the Vietnam experience rather than exposure

to herbicides. Infertility usually incorporates two con-

cepts: the inability to conceive and the inability to pro-

duce live children. Most studies do not take into ac-

count the desire for children, contraceptive practices,

and other factors influencing fertility. NAS found

no occupational or environmental studies examining

herbicide exposure and infertility, and veteran studies

(Field B., Kerr C., 1988. Reproductive behavior and

consistent patterns of abnormality in offspring of Vietnam

veterans. Journal of Medical Genetics 25:819-826; AFHS,

1992; Centers for Disease Control (CDC), 1988. Health

status of Vietnam veterans. III. Reproductive outcomes

and child health. Journal of the American Medical As-

sociation 259:2715-2717) do not support an association

between herbicide exposure and infertility. Accordingly,

the Secretary has found that the credible evidence against

an association between abnormal sperm parameters and

infertility and herbicide exposure outweighs the credible

evidence for such an association, and he has determined

that a positive association does not exist.

Studies of cognitive and neuropsychiatric disorders are

beset by a number of methodologic problems, including

exposure measures, the wide variety of “standardized”

test instruments used, and the inability to detect or cor-

rect for other influences on test results such as emotional

state, non-neurologic disease, metabolic conditions, fatigue,

medications, or style of the examiner. Because of their

failure to adequately control for these confounding factors,

39a

these studies lack credibility in assessing the relationship

of herbicide exposure to these conditions. Accordingly,

the Secretary has found that there is no credible evidence

fo aii association between cognitive and neuropsychiatric

disorders and herbicide exposure, and he has determined

that a positive association does not exist.

There were no significant studies available to analyze

whether an association exists between herbicide exposure

and motor/coordination dysfunction. Accordingly, the

Secretary has found that there is no credible evidence for

an association between motor/coordination dysfunction

and herbicide exposure, and he has determined that a

positive association does not exist.

Metabolic and digestive disorders (diabetes mellitus,

hepatic enzyme abnormality, lipid abnormalities, and

ulcers) were also categorized by NAS as health outcomes

with inadequate/insufficient evidence to determine whether

an association exists. Although NAS found no biologic

basis to suspect an association between herbicide ex-

posure and diabetes, abnormal glucose tolerance tests have

been reported in three studies (Sweeney M.H., Fingerhut

M.A., Arezzo J.C., Hornung R.W., Connally L.B. In

press. Peripheral neuropathy after occupational exposure

to 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD); Air Force

Health Study. 1991. An Epidemiologic Investigation of

Health Effects in Air Force Personnel Following Ex-

posure to Herbicides. Serum Dioxin Analysis of 1987

Examination Results. Brooks AFB, TX: USAF School of

Aerospace Medicine. 9 vols.; Pazderova Vejlupkova J.,

Lukas E., Nemcova M., Pickova J., Jirasek L., 1991. The

development and prognosis of chronic intoxication by

tetrachlorodibenzo-p-dioxin in men. Archives of Environ-

mental Health 36:5-11). While this suggests such an

association, the evidence is inconclusive and its credibility

is questionable because an abnormal glucose tolerance

test is not an absolute indicator of diabetes and none of

these studies allowed for the confounding role of obesity.

Two other studies found no association (Moses M.., Lilis

40a

R., Crow K.D., Thornton J., Fischbein A., Anderson

H.A., Selikoff I.J., 1984. Health status of workers with

past exposure to 2,3,7,8-tetrachlorodibenzo-p-dioxin in the

manufacture of 2,4,5-trichlorophenoxyacetic acid: Com-

parison of findings with and without chloracne. American

Journal of Industrial Medicine 5:161-182; Suskind and

Hertzberg, 1984), and a number of studies have shown

no increased death rates from diabetes (Bertazzi et al.,

1989) Cook R.R., Bond G.G., Olson R.A., Otto M.G.,

1987. Update of the mortality experience of workers

exposed to chlorinated dioxins. Chemosphere 16:2111-

2116; Henneberger P.K., Ferris B.G. Jr., Monson R.R..,

1989. Mortality among pulp and paper workers in Ber-

lin, New Hampshire. British Journal of Industrial Medi-

cine 46:658-664). Accordingly, the Secretary has found

that the credible evidence against an association between

diabetes and herbicide exposure outweighs the credible

evidence for such an association, and he has determined

that a positive associations does not exist.

The studies related to hepatic enzyme abnormality did

not demonstrate an association with liver disease, and

confounding factors (alcohol abuse, cirrhosis, hepatitis,

and other toxic chemicals) were not ruled out. Studies

showing lipid abnormalities do not control for the con-

founding variables of obesity and genetic factors, and no

medical significance of the modest and variable increases

has been demonstrated. The risk of gastric ulcers in

exposed populations has not been sufficiently studied to

many factors (e.g., alcoholism, non-steroidal anti-inflam-

matory drugs, and H. pylori infection) known to be

ciated with ulcers. Accordingly, the Secretary h

that a positive association does not exist.

4la

The available data deal with two categories of immune

system disorders: immune modulation and autoimmunity.

Many immune parameters have been studied; however,

few show a relationship to herbicide exposure. Most

studies address such a wide range of immune parameters

that it is likely that at least some of the positive results

are due to chance alone, which undermines the credibility

of those studies. Furthermore, the clinical meaning, i.e.,

the relationship of immune disorders to disease, is unclear.

Other studies (e.g., Pocchiari F., Silano V., Zampieri A..,

1979. Human health effects from accidental release of

tetrachlorodibenzo-p-dioxin (TCDD) at Seveso, Italy.

Annals of the New York Academy of Sciences 320:311-

320; Ghezzi I., Cannatelli P., Assennato G., Merlo F.,

Mocarelli P., Brambilla P., Sicurello F., 1982. Potential

2,3,7,8-tetrachlorodibenzo-p-dioxin exposure of Seveso de-

contamination workers. A controlled prospective study.

Scandinavian Journal of Work, Environment, and Health

8:176-179) found no relationship between immune system

disorders and herbicide exposure. Accordingly, the Secre-

tary has found that the credible evidence against an asso-

ciation between immune system disorders and herbicide

exposure outweighs the credible evidence for such an

association, and he has determined that a positive asso-

ciation does not exist.

Most occupational studies concerning circulatory dis-

orders (e.g., Moses et al., 1984; Suskind and Hertzberg,

1984) showed no increased mortality or morbidity from

circulatory disorders after herbicide exposure. The studies

of the residents of Seveso, Italy (Bertazzi, P.A., Zocchetti

C., Pesatori A.C., Guercilena S., Sanarico M., Radice L.,

1989a. Mortality in an area contaminated by TCDD

following an industrial incident. Medicina Del Lavoro

80:316-329; Bertazzi et al., 1989b) showed some in-

creased risk of mortality in the first five year follow-up;

however, these studies had a number of technical prob-

lems: they were not specific to circulatory disease and

did not control for the confounding variables of smoking,

42a

diabetes, and hypertension. Veteran studies (e.g., CDC,

1988) have suggested that any increase in heart disease

may be associated with the Vietnam experience rather

than herbicide exposure, and most of these studies did not

adjust for confounding variables. Accordingly, the Secre-

tary has found that the credible evidence against an asso-

ciation between circulatory diseases and herbicide ex-

posure outweighs the credible evidence for such an associ-

ation, and he has determined that a postitive association

does not exist.

NAS examined studies that covered a wide variety of

respiratory disorders (e.g., chronic bronchitis, asthma,

pleurisy, pneumonia, and tuberculosis), other than respira-

tory cancer. Studies of individuals exposed in occupa-

tional settings revealed no increase in mortality from

respiratory disease (Coggon D., Pannett B., Winter P.,

1991. Mortality and incidence of cancer at four factories

making phenoxy herbicides. British Journal of Industrial

Medicine 48:173-178; Blair A., 1983. Lung cancer and

other causes of death among licensed pesticide applicators.

Journal of the National Cancer Institute 71:31-37; Ala-

vanja et al., 1989; Coggon D., Pannett B., Winter P.D..,

Acheson E.D., Bonsall J.. 1986. Mortality of workers

exposed to 2-methyl-chlorophenoxyacetic acid. Scandi-

navian Journal of Work, Environment, and Health 12:448-

454). Environmental exposure studies similarly showed

no significant differences in mortality due to respiratory

disease (Bertazzi et al., 1989a,b). Also, mortality studies

of Vietnam veterans generally found no increased risk.

Morbidity data are generally difficult to evaluate because

of methodological problems and because studies focused

on symptoms, lung function tests and x-ray interpretation

rather than disease (e.g. Calvert et al.. 1991; Pollei S..

Mettler F.A. Jr.. Kelsey C.A., Walters M.R., White R.E.,

1986. Follow-up chest radiographs in Vietnam veterans:

Are they useful? Radiology 161:101-102). One occupe-

tional study (Calvert G.M.. Sweeney M.H.. Morris J.A.,

Fingerhut M.A., Hornung R.W., Halperin W.E.. 1991.

43a

Evaluation of chronic bronchitis, chronic obstructive pul-

monary disease, and ventilatory function among workers

exposed to 2,3,7,8-tetrachlorodibenzo-p-dioxin. American

Review of Respiratory Disease 144:1302-1306) showed

no excess morbidity; another occupational study (Suskind

and Hertzberg, 1984) found increased symptomatology of

respiratory disease, but did not adequately control for the

confounding factor of age. Accordingly, the Secretary

has found that the credible evidence against an association

between respiratory disorders and herbicide exposure out-

weighs the credible evidence for such an association, and

he has determined that a positive association does not

exist.

NAS noted an association between nasal cancers and

occupational exposure to nickel and to chromates. Ex-

posure to wood dust is also a risk factor for nasal cancers;

smoking and exposure to formaldehyde may increase the

risk associated with wood dust. There is also evidence

that leather workers have an increased risk for nasal

cancers, and that there is an association between chronic

nasal diseases and consumption of salt-preserved foods.

Most studies (e.g. Wiklund, 1983; Ronco et al., 1992)

showed inconclusive results, and often did not control for

confounding variables. Two other epidemiological studies

based on the same three cases (Saracci et al., 1991;

Coggon D., Pannett B., Winter P.D.. Acheson E.D., Bon-

sal J.. 1986. Mortality of workers exposed to 2 methy!l-

4-chlorophenoxyacetic acid. Scandinavian Journal of

Work, Environment, and Health 12:448-454) and one

case-control study (Hardell L.. Johansson B., Axclson O..,

1982. Epidemiological study of nasal and nasopharyn-

geal cancer and their relation to phenoxy acid or chloro

phenol exposure. American Journal of Industrial Medi-

cine 3:247-257) showed increased risk associated with

herbicide exposure; however, that risk was not statistically

significant, which diminshes the importance of these

studies. Accordingly, the Secretary has found that the

credible evidence against an association between nasal

44a

nasopharyngeal cancers and herbicide exposure outweighs

the credible evidence for such an association, and he has

determined that a positive association does not exist.

NAS also reviewed the literature with respect to pos-

sible assocations between herbicide exposure and various

reproductive effects, i.e., spontaneous abortion, birth de-

fects, neonatal infant deaths and stillbirths, low birth

weight, and childhood cancers in offspring. These repro-

ductive effects were categorized by NAS as health out-

comes with inadequate insufficient evidence to determine

whether an association exists because the studies were of

inadequate statistical power for specific birth defects, con-

tained a limited sample size, and/or failed to exclude bias

and chance. It should be noted that to compensate a

veteran for these conditions is beyond VA’s authority

(See title 38, U.S.C.) and would require enabling legis-

lation.

NAS assigns four diseases or categories of diseases to

a category labeled limited/suggestive evidence of no asso-

ciation with herbicide exposure which it defined as mean-

ing that several adequate studies, covering the full range

of levels of exposure that humans are known to encoun-

ter, are mutually consistent in not showing a positive asso-

ciation between herbicide exposure and the particular

health outcome at any level of exposure. The conditions

include skin cancer, gastrointestinal tumors (stomach can-

cer, pancreatic cancer, colon cancer, and rectal cancer),

bladder cancer, and brain tumors. There were many

credible studies (See NAS Report, Chapter 8) concerning

all of these conditions that showed no association or a

negative association with herbicide exposure. Accord-

ingly, the Secretary has found that there is no credible

evidence for an association between skin cancer, gastro-

intestinal tumors (stomach cancer, pancreatic cancer,

colon cancer, and rectal cancer), bladder cancer, and

brain tumors and herbicide exposure, and he has deter-

mined that a positive association does not exist.

45a

NAS reviewed approximately 6,420 abstracts of scien-

tific or medical articles as an integral part of the process

that resulted in its report, entitled “Veterans and Agent

Orange: Health Effects of Herbicides Used in Vietnam.”

From these articles, approximately 230 epidemiologic

studies, including studies of people exposed to herbicides

in occupational and environmental settings as well as

studies of Vietnam veterans, were chosen for detailed re-

view and analysis. In our judgment the comprehensive

review and evaluation of the available literature which

NAS conducted in conjunction with its report has _per-

mitted us to identify all conditions for which the current

body of knowledge supported finding of an association

with her exposure. Accordingly, the Secretary has deter-

mined that there is no positive association bet

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