Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-caDC-94-05013/USCOURTS-caDC-94-05013-0/pdf.json

Nature of Suit Code: 890
Nature of Suit: Other Statutory Actions
Cause of Action: 

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United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued February 2, 1995 Decided April 25, 1995

No. 93-5404

THE AMERICAN LEGION,

APPELLANT

v.

EDWARD DERWINSKI, SECRETARY, DEPARTMENT OF

VETERANS AFFAIRS;

DONNA E. SHALALA, SECRETARY, DEPARTMENT OF HEALTH AND

HUMAN SERVICES;

WILLIAM L. ROPER, M.D., DIRECTOR, CENTERS FOR

DISEASE CONTROL;

VERNON N. HOUK, DIRECTOR, CENTER FOR ENVIRONMENTAL 

HEALTH AND INJURY CONTROL CENTER;

UNITED STATES OF AMERICA,

APPELLEES

and Consolidated Case No. 94-5013

VIETNAM VETERANS OF AMERICA;

HAROLD A. BUTLER; CAROL RIDOLFI-DELANEY;

MAREL J. MACKI; BEVERLY NEHMER,

APPELLANTS

v.

EDWARD DERWINSKI, SECRETARY, DEPARTMENT OF

VETERANS AFFAIRS;

DONNA E. SHALALA, SECRETARY, DEPARTMENT OF HEALTH AND HUMAN SERVICES;

WILLIAM L. ROPER, M.D., DIRECTOR, CENTERS FOR

DISEASE CONTROL;

VERNON N. HOUK, DIRECTOR, CENTER FOR ENVIRONMENTAL 

HEALTH AND INJURY CONTROL CENTER;

UNITED STATES OF AMERICA,

APPELLEES

Appeals from the United States District Court

for the District of Columbia

(90cv1808)

Gershon M. Ratner argued the cause for appellants. With him on the briefs were Mark A. Venuti and

Ron Simon. Barton F. Stichman entered an appearance for appellants.

Jonathan R. Siegel, Attorney, United States Department of Justice, argued the cause for appellees.

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1

In 1988, Congress redesignated the Veterans Administration as the Department of Veterans

Affairs and named the Secretary of Veterans Affairs (previously, the Administrator of Veterans'

Affairs) to head the department. Department of Veterans Affairs Act, Pub. L. No. 100-527, 102

Stat. 2635 (1988). We use the current title "Secretary" in this opinion whenever the statute or

record refers to the Administrator of Veterans' Affairs. 

With him on the brief were Frank W. Hunger, Assistant Attorney General, Eric H. Holder, Jr.,

United States Attorney, and Robert S. Greenspan, Attorney, United States Department of Justice.

Before: EDWARDS, Chief Judge; RANDOLPH and ROGERS, Circuit Judges.

Opinion for the court filed by Circuit Judge ROGERS.

ROGERS, Circuit Judge: The American Legion and others appeal from the grant of summary

judgment rejecting their challenge to the decision of the Secretary of Veterans Affairs to abandon a

congressionally mandated epidemiological study of the effects of exposure to dioxin, a by-product

of Agent Orange and other herbicides, on Vietnam veterans.1 The district court ruled that the

Secretaryhad acted within his discretion in abandoning the Agent Orange Study, which the Secretary

had commissioned the Centers for Disease Control to design and conduct, after determining that

sampling problems made it unlikely that the investigation would yield scientifically valid results.

American Legion v. Derwinski, 827 F. Supp. 805, 812-14 (D.D.C. 1993). Appellants contend that

the Secretary erroneously relied on a repealed standard as the basis for abandoning the study and

violated the statute by halting the study before submitting a mandated report of health results to

Congress; alternatively, they challenge as arbitrary and capricious the Secretary's conclusion that a

scientifically valid study was impossible. Finding these contentions unpersuasive, we affirm.

I.

As background to appellants' contentions, we first outline the statute and the Secretary's

efforts to implement the statutory directive for an epidemiological study on the effects of exposure

to dioxins during the Vietnam conflict.

A. The Statute. In enacting the Veterans' Health Programs Extension and Improvement Act

of 1979, Pub. L. No. 96-151, 93 Stat. 1092 (codified as amended at 38 U.S.C. § 219 note (1988)),

reprinted as amended in 38 U.S.C.A. § 527 note (1991) (the "1979 Act"), Congress sought to

determine by means of an epidemiological study the health effects of exposure to Agent Orange and

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2Epidemiology is "a branch of science and medicine [that] uses studies to "observe the effect of

exposure to a single factor upon the incidence of disease in two otherwise identical populations.' " 

DeLuca v. Merrell Dow Pharmaceuticals, Inc., 911 F.2d 941, 945 (3d Cir. 1990) (quoting Black

& Lilienfeld, Epidemiological Proof in Toxic Tort Litigation, 52 Fordham L. Rev. 732, 755

(1984)); see also Affidavit of Dr. Zena A. Stein, proffered by appellants, at 2. 

3TCDD stands for 2,3,7,8-Tetrachlorodibenzo-p-Dioxin, a by-product created during the

manufacture of certain herbicides. 

4

See 1979 S. REP. at 37-39; Health Study Protocol at 4-5. 

other herbicides on Vietnam veterans.2Id. § 307; see also S. REP. NO. 260, 96th Cong., 1st Sess.

36-40 (1979) ("1979 S. REP."), reprinted in relevant part in 1979 U.S.C.C.A.N. 1894, 1922-1926.

These herbicides, which the United States military used during the Vietnam conflict, contain varying

amounts of dioxinsalso referred to as TCDD3which studies have suggested can cause harmful

health effectsin laboratory animals and consequently led to concern about similar effectsin humans.4

Congress sought to determine whether Vietnam veterans had suffered such adverse health effects as

a result of their military service and, if so, to compensate them for their injuries. See 1979 S. REP.

at 38-40.

The 1979 Act directed the Secretary to conduct an epidemiological study pursuant to a

protocol approved by the director of the congressional Office of Technology Assessment ("OTA").

1979 Act § 307(a)(2)(A)(i). The statute also required the director of OTA to oversee the conduct

of the study and report its oversight activities to the appropriate congressional committees. Id. §

307(a)(2). Further, as part of the effort to ensure that the study was "scientifically valid and ...

conducted with efficiency and objectivity," the 1979 Act directed the President to coordinate the

Secretary'sstudy with any other Federal governmentalstudies on the effects of dioxins. Id. § 307(c).

The 1979 Act expressly required, however, that the Secretary continue the study only "for as long

after the submission of [his first] report [to Congress on "the results thus far obtained under the

study'] ... asthe [Secretary] may determine reasonable in light ofthe possibilityof developing through

such study significant new information on the long-term adverse health effects of exposure to

dioxins." Id. § 307(a)(3), (b)(2).

The 1979 Act initially called for an epidemiologicalstudy of veterans who "were exposed to"

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5The two other studiesthe "Vietnam Experience" study, to assess the "possible health effects

of the general Vietnam experience," and the "Sarcoma/Lymphoma" or "Selected Cancers" study,

to "evaluate the risk of contracting soft tissue sarcoma and lymphoma among Vietnam veterans

(and/or those exposed to herbicides)"have been completed and are not at issue in these appeals. 

dioxins during the Vietnam conflict. Id. § 307(a)(1) (amended 1981). From the outset, a major

obstacle to completion ofthe studywasthe identification of veterans, other than "Ranch Hands" who

did the actual spraying, who had been exposed to Agent Orange during their service in Vietnam. S.

REP. NO. 89, 97th Cong., 1st Sess. 25 (1981) ("1981 S. REP."). To address this problem, Congress

amended the statute in 1981 to require a study of veterans' health effects that "may result" from

exposure to dioxins. Veterans' Health Care, Training, and Small Business Loan Act of 1981, Pub.

L. 97-72 § 401(a)(1), 95 Stat. 1061 (1981) (codified at 38 U.S.C. § 219 note (1988)), reprinted in

38 U.S.C.A. § 527 note ("1981 Amendments"). The 1981 Amendments also expanded the scope of

the study to examine health effects that may have resulted from other factors in the overall Vietnam

experience, "including exposure to other herbicides, chemicals, medications, or environmental hazards

or conditions." Id. According to the Senate Report, the amendments were intended to "allow the

Secretary to begin the study of the health status of these veterans by identifying a population of

veterans who served in Vietnam, without first having to determine whether each was, without

question, exposed to Agent Orange in Vietnam." 1981 S. REP. at 26.

B. The Health Study Protocol and Pilot Study. Following enactment of the 1981

Amendments, the Secretary entered into a contract with the Centers for Disease Control ("the

Center") to design a protocol for the epidemiological investigation. The Center's Health Study

Protocol, completed in November 1983, proposed three studies to evaluate the health of Vietnam

veterans, one of which was the "Agent Orange" Study, designed to examine the effects of exposure

to Agent Orange and other herbicides on veterans' health. See United States Department of Health

and Human Services, Public Health Service, Centersfor DiseaseControl, Protocolfor Epidemiologic

Studies of the Health of Vietnam Veterans (November 1983) at 1, 6-9 ("Health Study Protocol").5

To isolate the effects of dioxin exposure, theCenter needed to distinguish between groups ofVietnam

veterans who were similar except for their level of dioxin exposure. See supra n.2. The Health Study

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Protocol proposed to use military records to divide a sample of Vietnam veterans into those who

were likely exposed to herbicides in Vietnam and those likely not exposed and then to compare the

health of the two cohorts. Health Study Protocol at 6-7, 10-15. The Center planned to review

battalion journal files and morning reports to locate companies at various times during the Vietnam

conflict and to determine the presence or absence of individuals within the company. Utilizing

herbicide usage reports such as aircraft spraying records to estimate the location and timing of

herbicide applications, the Center planned to fit veterans into the "likely exposed" or "likely not

exposed" cohort "according to the measure of their company's distance in time and space from any

herbicide applications." Id. at 6. To measure the possible health effects of dioxins, the Center would

then compare the medical histories of "likely exposed" and "likely not exposed" veterans based on

review of mortality records, health interviews, medical examinations, and laboratory tests. Id. at 20-

25.

The Health Study Protocol cautioned that certain "obstacles" prevented the Center from

adopting the "ideal" design for an Agent Orange cohort study, which would have compared one

group free from all exposure to another group subjected to "meaningful" exposure to herbicides.

These obstacles included the difficulty of defining "meaningful exposure" and the uncertainty about

whether exposed veterans were comparable to unexposed veteransin other characteristicsthat might

affect health. Most significant for purposes of these appeals, the Protocol noted that the "uneven

quality" of the military records, including gaps in company records and errors in herbicide usage

records, meant that "the categorization of individuals with respect to their potential for herbicide

exposure will be uncertain and will forever remain so." Id. at 6. The Health Study Protocol

concluded that "[s]ince many of the proposed procedures are untested, modification, indeed even a

recommendation not to proceed with an Agent Orange Study, may be required...." Id. at 11.

The Center's initial review, conducted from 1983 to 1986, confirmed its concern that

inadequacies in the military documentation would likely make identification of appropriate cohorts

impossible. Informed of these difficulties, OTA advised Congress in September 1985 that if the

difficulties in evaluating exposure were not resolved, OTA might conclude that the "it is impossible

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6A veteran received a score of one "hit" for each day that his company was located within 2

kilometers of a reported Agent Orange spray line applied within the previous 6 days. 

to study the effects of Agent Orange." OTA subsequently suggested that the Center postpone any

"major new phase" ofits Agent Orange Study until it had devised an appropriate means of estimating

exposure and recommended that instead of proceeding with the interviews of study subjects

scheduled to begin in January 1986, the Center conduct a pilot study to test the methods and results

of its initial exposure assessments. Accordingly, the Environmental Support Group of the United

States Army and Joint Services developed a pilot study, at the Center's request, to identify "heavily

exposed personnel." Completed in mid-1986, the pilot study ranked veterans based on their number

of "hits," or opportunities for exposure to Agent Orange; veterans with the largest number of "hits"

were classified as those most likely to have faced heavy exposure.6

In early1986, theAgent OrangeWorkingGroup ("WorkingGroup"),formed bythePresident

to carry out his responsibilities under the 1979 Act, convened a Science Subpanel on Exposure

Assessment ("Science Subpanel") to evaluate the Center's exposure assessment methods and review

the results of the pilot study. In a May 26, 1986, letter to the Working Group, the Science Subpanel

concluded that two problems jeopardized the Center's Agent Orange Study: first, the potential for

"considerable" misclassification because of unit dispersion and incomplete records of spray

operations; and second, the fact that the Center's records review showed that most veterans had

never been exposed to a "hit," as defined by the Center, and thus "the paucity of clearly exposed

combat veterans makes it questionable whether a sufficient number can be assembled to conduct an

epidemiological study of the type originally designed." The Science Subpanel noted that recent

scientific advances might enable the Center more accurately to identify cohorts of likely exposed and

likelyunexposed veterans, but that given the problems with current identificationmethods, "anystudy

of ground troops, which is dependent upon military records for the assessment of exposure to

herbicides, [should] not be conducted without an additional method to verify exposure."

C. The TCDD Validation Study. Responding to the recommendations from OTA and the

Science Subpanel not to proceed with a military records-based study without some independent

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7Although the Center did not know the precise half-life of TCDD at the time it developed its

TCDD protocol, it determined in the course of the study that TCDD has an average half-life of

seven years. The half-life of a substance is "the time required by the body, tissue, or organ to

metabolize or inactivate half the amount of a substance taken in." F.A. DAVIS, TABER'S

CYCLOPEDIC MEDICAL DICTIONARY at 717 (1985). 

8The Center controlled for differences such as age, race, region of current residence, body

mass index, alcohol use, smoking history, and self-reported civilian occupational and home

exposure to herbicides. Id. at 23. The study also considered the impact of other factors that

might lead to study biasgroup selection, laboratory error or measurement bias, variability in

half-life, selection or participation bias, and sample sizeand concluded that none of these factors

likely influenced the results. Id. at 27-30. 

verification, the Center developed a protocol to compare current serum TCDD levels in veterans'

blood. Assuming TCDD survived in the blood for several years, the Center postulated that veterans

who faced "heavy" exposure could be expected to have higher serum TCDD levels than lesser

exposed veterans even twenty years after their exposure to Agent Orange.7 The Center used both

the pilot study's "hit"-based exposure indices and veterans'self-reported exposure estimatesto divide

a set of Vietnam veterans into "low hit," "medium hit," and "high hit" subsets and, for comparison,

also examined a group of non-Vietnam veterans of the same era.

The results ofthe TCDD study confirmed the Center'ssuspicionsthat neither military records

nor self-reporting could adequately differentiate between veterans who were and were not likely

exposed to Agent Orange in Vietnam. U.S. Department of Health & Human Services, Centers for

DiseaseControl,ComparisonofSerumLevels of2,3,7,8-Tetrachlorodibenzo-p-DioxinWithIndirect

Estimates of Agent Orange Exposure Among Vietnam Veterans: Final Report (August 1987)

("TCDD Report"). The Center found "no meaningful association" between veterans' current TCDD

levels and the exposure indices developed through either military records or self-reporting.8Id. at

1. Besides failing to validate the use of military records as exposure indicators, the TCDD study

reinforced the conclusion that ground troops faced little likelihood of "heavy" exposure to Agent

Orange. Id. at 2. The Center thus concluded that it could not conduct the cohort Agent Orange

Study that it had originally planned:

The findings of thisstudy and the conclusion from the Agent Orange Working Group

Science Subpanel report on exposure assessment (June 1986) do not identify any

method for using military records or self-reported exposure to distinguish between

U.S. Army ground combat troops who were and were not exposed to Agent Orange

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9The Secretary described Ranch Hand veterans as "the sole group of veterans ... available for

the successful epidemiological investigation envisaged by the Congress." 

in Vietnam, as would be needed for a cohort study of possible health effects.

Id. at 1.

In a review ofthe TCDD study, OTAagreed that "a large-scale epidemiologicalstudyto look

for effects of Agent Orange in ground troops who served in Vietnam" was currently impossible, and

cautioned that any future studies "should be narrowly focused on specific, testable hypotheses, and

cannot have the aim of generalizability to all or most ground troops." Id. at 9. On October 29, 1987,

the director of the Center reported to the Secretary the Center's concurrence with OTA and the

Working Group that the Agent Orange Study "cannot be conducted" and that the Center had begun

"the close-out process" for its Agent Orange Study.

D. The Secretary's decision. In December 1987, the Department of Medicine and Surgery

in the Veterans Administration recommended a halt to all further studies of the effects of Agent

Orange (other than the Air Force's Ranch Hand study). Because the results of the TCDD report

"make it exceedingly unlikely that any method will satisfactorily distinguish between exposed and

unexposed Vietnam veterans," the Department of Medicine and Surgery concluded that "a

scientifically meaningful epidemiologicalstudy of the possible health effects of Agent Orange cannot

be conducted."

On February 9, 1988, the Secretary sent the TCDD report, along with correspondence from

OTA and the Working Group, to the Chairman of the House Committee on Veterans' Affairs. In a

cover letter the Secretary stated that:

Despite our efforts, ... no one has successfully identified a large enough group of

Vietnam veterans known to have been exposed to Agent Orange or other herbicides

to allow the preparation of a protocol and the conduct of an epidemiologicalstudy as

required by Public Law 96-151.[9 ]I must, therefore, advise you that no scientifically

sound study can be undertaken and request that the [Veterans Administration] be

relieved of the requirement to do this research. This opinion coincides with that of

the Office of Technology Assessment, as expressed in their comments of September

1987, and with the June 3, 1987, comments of the interagency Agent Orange

Working Group.

A week later, the Secretary formally notified the Chairman of the decision to discontinue work on the

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10In accord with the Secretary's recommendation that any allocated but unexpended funds be

reallocated to either "the U.S. Air Force's Ranch Hand Study's blood dioxin levels research or

other research on Agent Orange and closely related subjects," Congress in 1988 transferred

$3,000,000 of the unexpended funds for blood tests in the Ranch Hand study and $1,000,000 for

"a survey of scientific evidence, studies, and literature" regarding the health effects of possible

herbicide exposure in Vietnam, to be conducted by an independent scientific entity under contract

with the VA, "pursuant to a law enacted after the date of the enactment of this Act." See § 1201

of Pub. L. No. 100-687, 102 Stat. 4105, 4125 (1988). Subsequently, in 1991, Congress

authorized the National Academy of Sciences to review and evaluate the available scientific

studies regarding the health effects of herbicide exposure and required the Secretary to enact

regulations establishing a presumption that any malady correlated with herbicide exposure is

service-related. Agent Orange Act of 1991, Pub. L. No. 102-4, 105 Stat. 11 (1991) (codified as

amended at 38 U.S.C. § 1116 & note (Supp. IV 1992)). 

Center's Agent Orange Study. On February 19, 1988, in his third annual report to Congress on the

status of the Center's three-part Health Study, the Secretary repeated his conclusion that "based on

the results of the ... TCDD Validation Study, ... an [Agent Orange Study] cannot be conducted so

as to achieve a scientifically sound conclusion regarding the possible adverse health effects of

exposure of Vietnam veterans to Agent Orange."10

Appellants thereafter filed suit, contending that the Secretary unlawfully abandoned the

Center's Agent Orange Study based on the wrong legalstandard, that the Secretary lacked authority

to terminate the Agent Orange Study before submitting a health results report to Congress, and that

his decisionwas contraryto the Administrative Procedure Act, 5 U.S.C. § 706. Following the district

court's grant of summary judgment for appellees, appellants filed these consolidated appeals.

II.

In addressing appellants' challenges to the grant ofsummary judgment in favor of appellees,

our review is de novo. Diamond v. Atwood, 43 F.3d 1538, 1540 (D.C. Cir. 1995); Shields v. Eli

Lilly & Co., 895 F.2d 1463, 1466 (D.C. Cir. 1990). Thus, the limited questions before the court are

whether the Secretary adopted a "permissible" interpretation ofthe 1979 and 1981 Acts,see Chevron

U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 841-42 (1984), and, if so,

whether, as a matter of law, the Secretary's decision in February 1988 to abandon the Center's Agent

Orange Study was arbitrary and capricious, an abuse of discretion, or otherwise contrary to law. 5

U.S.C. § 706(2)(A); Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 416 (1971);

Dr. Pepper/Seven-Up Companies, Inc. v. FTC, 991 F.2d 859, 862 (D.C. Cir. 1993). In reviewing

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the Secretary's decision to abandon the study, the court's task is to determine whether the Secretary

"examine[d] the relevant data," and made a "rational connection between the facts found and the

choice made." Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983)

(internal quotations omitted); see also Citizensto Preserve Overton Park v. Volpe, 401 U.S. at 416.

Given the nature of the scientific expertise brought to bear on the issue of whether to continue the

Center's Agent Orange Study, the court'sreview is at its most deferential. Baltimore Gas & Electric

Co. v. Natural Resources Defense Council, Inc., 462 U.S. 87, 103 (1983).

A. Reporting "results". Appellants contend that the Secretary violated the statute by

abandoning the Center's Agent Orange Study before reporting actual health results to Congress.

Section 307(b)(2) of the 1979 Act provides:

Not later than twenty-four months after the date of the approval of the protocol ...

and annually thereafter, the [Secretary] shallsubmit to the appropriate committees of

the Congress a report containing (A) a description of the results thus far obtained

under the study conducted pursuant to this subsection, and (B) such comments and

recommendations as the [Secretary] considers appropriate in light of such results.

[Emphasis added].

Appellants maintain that the word "results" in § 307(b)(2) means substantive health results, and

hence, that the Secretary lacked authority to abandon the Center's Agent Orange Study before

reporting to Congress the Center's conclusions about adverse health effects of Agent Orange and

other herbicides on Vietnam veterans. See id. § 307(a)(3) as amended by 1981 Amendments §

401(a)(2) (Secretary may discontinue the study "after the submission of the first report under

subsection (b)(2)"). The Secretary interprets "results" under § 307(b)(2) to include the progress

made thus far to carry out the study and maintains that he fulfilled § 307(b)(2)'s requirement when

he provided Congress with a progress report on February 13, 1986.

In reviewing the Secretary's interpretation of § 307(b)(2), we apply the standard of review

set forth in Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 841-42

(1984). Because, contrary to appellants' contentions, neither the plain language nor the structure of

the statute makes clear Congress' intent to confine "results" to "health results" in mandating reports

by the Secretary, the court must defer to the Secretary'sinterpretation if it "is based on a permissible

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11Although Chevron deference would not apply if the Secretary had adopted this interpretation

solely for purposes of litigation, see City of Kansas City, Mo. v. HUD, 923 F.2d 188, 192 (D.C.

Cir. 1991), the interpretation at issue appeared in the Secretary's February 13, 1986, report to

Congress, in which he stated: "As required by Section 307 of Public Law 96-151 ... I am sending

you and your committee the first status report and its appendices" on the Agent Orange Study. 

construction of the statute." Id. The Secretary's interpretation accordingly invokes our deference.11

Because the Secretary'sinterpretation of "results" is consistent with Congress' use of that term in the

statute, see 1979 Act § 307(b)(2), and appellants' construction of congressional intent would lead to

absurd results, the Secretary's interpretation withstands scrutiny.

TheSecretary'sinterpretationthat "resultsthusfar obtained under the study"meansthe results

of the Secretary's efforts pursuant to the statute is not an impermissible construction of § 307(b)(2).

The word "results" is hardly a technical term of art, but one of common parlance subject to multiple

meanings. Thus, "results" may include conclusions that the Secretary has reached in the course of

efforts to carry out the Center's Agent Orange Study and are not, as appellants suggest, necessarily

limited to "health results" produced by that study. The "result" of the TCDD study, for example, is

the conclusion that current blood serum levels bear no relation to military records-based exposure

assessments. The "results" of the pilot study are the index of "hit"-based exposure assessments and

the conclusion that most ground troops did not have the opportunity for heavy exposure to Agent

Orange. Both studies led, in one sense, to "results ... obtained under the study" since they followed

the Secretary's approval of the Health Study Protocol and represented efforts to develop data that

would enable the production of scientifically valid epidemiological conclusions.

Put otherwise, an epidemiological study on long-term health effects produces many types of

"results" that the Secretary could report to Congress. The fact that the statute requires the Secretary

to submit annual reports on the "results thus far obtained under the study" comports with the view

that Congress wanted regular progress reports on the results of the Secretary's efforts, whether or

not such reports contained substantive health results. See 1979 Act § 307(b)(2). Indeed, the

Secretary'ssubmission of various reports to Congress between 1986 and 1988 alerted Congressthat

the development ofscientifically valid health results depended on the identification of reliable indices

of cohort exposure. The language of § 307(a)(3) also supports the Secretary's interpretation; by

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12The fact that Congress directed the Secretary to consider various administrative actions

based on the "results" reported under § 307(b)(2) does not make his interpretation of "results"

unreasonable. See id. § 307(b)(2)(B), (b)(3). The statute requires the Secretary to submit

"comments and recommendations [that the Secretary] considers appropriate in light of such

results," id. § 307(b)(2)(B), and to give notice and comment of "actions, if any," that the

Secretary proposes to take in response to the results. Id. § 307(b)(3) (emphasis added). The

Secretary fulfilled the requirements of § 307(b)(2)(B) in his first and subsequent progress reports,

when he informed Congress of the proposed TCDD study and its results, notified Congress of the

Center's Agent Orange Study's abandonment, and recommended that the legislature reallocate

unused funds. See supra n.10. Subsection (b)(3) makes clear that the Secretary need not

recommend any "action" based on the study's "results." It is consistent with this subsection for

the Secretary to recommend no rulemaking action, given the "result" that the effects of Agent

Orange could not presently be ascertained. 

allowing the Secretary to abandon the study after submission of the first report if he finds it unlikely

that the study will yield "significant new information on the long-term health effects of exposure to

dioxins," subsection (a)(3) appears to contemplate that the Secretary's first report may not itself

contain information on adverse health effects.12 Id. § 307(a)(3).

Appellants' contrary statutory arguments are unpersuasive. First, appellants contend that

because the statute requires OTA to submit "updates" on the status of unapproved protocols, id. §

307(a)(2)(B)(ii), Congress must have intended "results" under § 307(b)(2) to mean more than a

progress report. Although courts generally presume that " "Congress acted intentionally and

purposely' " when particular language in one section of a statute is omitted in another section,

Russello v. United States, 464 U.S. 16, 23 (1983) (quoting United States v. Wong Kim Bo, 472 F.2d

720, 722 (5th Cir. 1972)), the statutory differences between the reporting requirements imposed on

OTA and the Secretary are consistent with the Secretary's interpretation of "results." OTA's

"updates" on the status of protocolrevisionsreflect only the status ofthe Secretary's plansto conduct

the study; because the Center's Agent Orange Study has not yet begun, the reports cannot contain

its "results." The Secretary's reports, by contrast, reflect information gathered in the process of

conducting the study, which can fairly be labeled "results thus far obtained under the study."

Similarlyunpersuasive is appellants'second contentionthat the differences between the Agent

Orange statute and a 1983 statute providing for an epidemiological study of the health effects of

radiation exposure, Veterans Health Care Amendments of 1983, Pub. L. 98-160 § 601, 97 Stat.

1006-08 (1983) (codified as amended at 38 U.S.C. § 219 note (1988)) (the "1983 Act"), demonstrate

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13Finally, while Congress' failure to consider the possibility that the study might not ultimately

yield substantive health results cannot form the basis for an interpretation contrary to the plain

meaning of a statute, see West Virginia Univ. Hosp., Inc. v. Casey, 499 U.S. at 100-01, where the

Secretary's interpretation comports with the language of the statute and an alternative

interpretation would produce absurd results, the fact that Congress did not specifically consider

the issue is irrelevant. See id.; see also Natural Resources Defense Council, Inc. v. EPA, 725

F.2d 761, 770 (D.C. Cir. 1984). 

that Congress intended to require the Secretary to provide "health results" in his reports pursuant to

§ 307(b)(2) of the 1979 Act. Although the 1983 Act explicitly gives the Secretary discretion not to

conduct a study if he finds a scientifically valid study infeasible, id. § 601(a)(1)(B), the fact that the

Secretary could not abandon the epidemiologicalstudy without developing a protocol and reporting

some kind of results does not mean that the "results" reported must be "health results." Nor is the

1983 Act's requirement of reports on "the progress ... and any results" of the radiation study, id. §

601(a)(5)(A), inconsistent with interpreting "results" as used in § 307(b)(2) of the 1979 Act to

include data and conclusions other than "health results." Absent either a conflict between the 1983

Act and the Secretary's interpretation or a clear contrary meaning of the word "results," we will not

read the 1983 Act to preclude the reasonable interpretation adopted by the Secretary. Compare West

Virginia University Hosp., Inc. v. Casey, 499 U.S. 83, 99-101 (1991).13

Indeed, the reasonableness of the Secretary's interpretation is manifest in light of the

implausibility of the alternative interpretation proposed by appellants. See United States v. Wilson,

112 S. Ct. 1351, 1354 (1992). Under their interpretation, Congress intended to require the Secretary

to proceed with the Center's Agent Orange Study and present its "results" to Congress even when

the Secretary knew that the inability to identify necessary data would render the results scientifically

useless. Not only do the 1981 Amendments and the Secretary's reports to Congress make clear that

Congress knew that the underlying data was problematic, but the various reporting requirements in

the statute highlight the unreasonableness of appellants' unsupported assumption that Congress

intended the Secretaryto devote resourcesto a studythat the Secretary, theCenter, the congressional

OTA, and the President's Working Group had all concluded could not yield the valid scientific results

mandated by statute. Other provisions in the statute also suggest that Congress did not intend the

Secretary to conduct a study unlessit was a scientifically valid one. Congress expressly required the

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141979 Act § 307(a)(1) (amended 1981). 

151981 Amendments § 401(a)(1). 

Secretary to conduct the study pursuant to a protocol approved by the director of OTA. 1979 Act

§ 307(a)(2)(A)(i). The director of the OTA was to assess scientific validity in his approval or

disapproval of the proposed protocol. Id. § 307(a)(2)(B)(i). Also, Congress directed the President

to monitor the study for the purpose of assuring that the study was scientifically valid. Id. § 307(c).

Assuming the accuracy of the Secretary's conclusion that a scientifically valid Agent Orange study

was infeasible, in the absence of a clear statutory command, the Secretary was not required to

proceed with a study that by all indications would not advance scientific knowledge solely to fulfill

the obligation to report "results."

Because the language and purpose of the statute support the Secretary's interpretation of

"results" as the progress made thus far in the Center's Agent Orange Study, we conclude that the

Secretary satisfied his initial reporting obligation under § 307(b)(2) of the 1979 Act when he

submitted a report to Congress on February 13, 1986, describing the results of efforts to carry out

the epidemiological study.

B. The Standard. Appellants contend that the Secretary acted contrary to law because he

decided to abandon the study based on the repealed standard of the 1979 Act (focusing on individual

veterans who "were exposed to ... dioxins")14 instead of the liberalized standard adopted in the 1981

Amendments (examining health effects that "may have resulted from exposure").15 Appellants rely

on the fact that in his February 9, 1988, letter to the Chairman of the House Committee on Veterans'

Affairs, the Secretary reported that he had not "successfully identified a large enough group of

Vietnam veterans known to have been exposed to Agent Orange or other herbicides to allow the

preparation of a protocol and the conduct of an epidemiologicalstudy as required by Public Law 96-

151." They also point to the beginning of the Secretary's letter where he referred to the repealed legal

standard in discussing the efforts made under the 1979 Act "[s]ince 1980." Appellants' emphasis on

this language, however, overlooks other language in the Secretary's letter that demonstrates that he

based his decision on concerns about scientific validity rather than compliance with the pre-1981

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statutory mandate, that the numerous reports before the Secretary recommended abandoning the

Center's Agent Orange Study because compliance with the 1981 mandate was not scientifically

possible, and that the TCDD study confirmed that military records could not yield adequate exposure

indices. 

As appellants point out, a reviewing court "must judge the propriety of [agency] action solely

by the grounds invoked by the agency." SEC v. Chenery Corp., 332 U.S. 194, 196 (1947). It is

equally true, however, that "we will uphold a decision of less than ideal clarity if the agency's path

may reasonably be discerned." Bowman Transp., Inc. v. Arkansas-Best Freight Sys., Inc., 419 U.S.

281, 285-86 (1974). Hence, even if some of the agency's remarks might appear erroneous when read

in isolation, the court will uphold agency action that, "[c]onsidered in its entirety," is based on

appropriate considerations and otherwise complies with relevant statutes and the Administrative

Procedures Act. District Lodge 64 v. NLRB, 949 F.2d 441, 446 (D.C. Cir. 1991). Such

consideration here indicates that the Secretary did not base his decision on the repealed statutory

standard.

First, that the Secretary's decision focused on problems with the cohort study designed

pursuant to the 1981 Amendmentsis evident from hisletter'sreference to the identification of a large

enough group of veterans, as distinct from the focus of the original 1979 Act on individuals who had

been exposed. The Secretary expressly incorporated by reference a separate statement by the

Veterans' Administration's Department of Medicine and Surgery that refersto the 1981 standard and

discussesthe effortsto "estimate the likelihood" of exposure to Agent Orange. He noted, moreover,

at the beginning of his letter that completion of the TCDD study "enabled the V[eterans']

A[dministration] to complete an attempt to determine directly and specifically whether exposure to

Agent Orange had an adverse effect on the health of Vietnam veterans," thereby indicating that as

addressed in the TCDD study, verification of exposure data remained the important factor under the

1981 standard. In context, therefore, the Secretary's reference to exposure suggests that the inability

to distinguish exposure levels among different groups of veterans meant that he could not establish

the data base necessary for a scientifically valid study.

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Second, the Secretary attached to his February 9, 1988, letter to Congress OTA's September

1987 report and the Working Group's comments of June 3, 1987; both documents recommended

abandonment of the Center's Agent Orange Study, not because of an inability to ensure that each

study subject was exposed to Agent Orange, but because current identification methods provided no

scientifically valid means of differentiating groups of veterans based on the degree of exposure, and

thus the long-term health effects of Agent Orange and other herbicides on the study subjects could

not be assessed. OTA and the Working Group thus concluded that "no scientifically sound study can

be undertaken."

Third, the Secretary also attached to his February 9, 1988, letter to Congress the TCDD

validation study, which confirmed that compliance with the 1981 statutory mandate was not feasible

because the Center was unable to classify groups of veterans based on their degree of exposure to

Agent Orange and other herbicides. The Center compared individual hit scores as well as median

TCDD levels by company, by the company in which the veteran spent the most time, and by the

companyinwhich the veteran had the most "hits." The Center concluded that neither individuals with

higher "hit" scores nor companies with predicted higher levels of exposure had, on average,

significantly higher TCDD levels in their blood, and therefore that it could not develop the data base

needed for a cohort epidemiological study.

Viewing the Secretary's February 9, 1988, letter together with the documents that he

incorporated by reference thus makes clear that notwithstanding the Secretary's reference to the

inability to identify veterans "known to have been exposed " to Agent Orange and other herbicides,

his decision to abandon the Center's Agent Orange Study rested on the inability to identify study

cohorts based on the degree of exposure. Although Congress anticipated that the 1981 Amendments

would remove the threshold problem of identifying individual veterans who were exposed to Agent

Orange, 1981 S. REP. 26, 33, the amendments left in place the requirement that the study yield

scientifically valid results. Appellants appear to ignore or underestimate the significance of the fact

that even under the 1981 Amendments the epidemiology study depended on exposure data, and that

the Center's Agent Orange Study relied on the ability to determine the degree of exposure

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experienced by different groups of veterans. Thus, notwithstanding the Secretary's unfortunate

choice ofsome words in his February 9 letter, the references noted by appellants cannot be divorced

from the Secretary's references to "a large enough group" and the enclosed statement of the

Department of Science and Medicine or fairly understood without regard to the supporting materials

on which he relied in making his decision. For these reasons, we conclude that the Secretary did not

rely on an improper legal standard in deciding to abandon the Agent Orange epidemiological study.

C. Abandoning the original Agent Orange Study. Because appellants' other challenges

fail, the success of their appeals turns on whether, as a matter of law, the Secretary acted arbitrarily

and capriciously in determining in February 1988 that a scientifically valid epidemiologicalstudy was

infeasible. Appellants maintain that the "risk" of misclassification cannot alone make an

epidemiological study scientifically invalid and that the Secretary had no evidence to support the

conclusion that the degree of misclassification was sufficiently high to make valid scientific results

unobtainable.

The statute vests the Secretary with broad discretion to abandon the entire epidemiological

studyif, after hisinitialreport to Congress, the Secretary determinesthat the studywillyield no useful

scientific results.

The study ... shall be continued for as long after the submission of the first report

under subsection (b)(2) as the [Secretary] may determine reasonable in light of the

possibility of developing through such study significant new information on the

long-term adverse health effects of exposure to dioxins.

1979 Act § 307(a)(3) as amended by 1981 Amendments § 401(a)(2). Given this broad discretion,

the scope of our review of the Secretary's decision to abandon one component of the Health Study

Protocol is particularly limited. See Kreis v. Secretary of Air Force, 866 F.2d 1508, 1514 (D.C. Cir.

1989) ("[i]t is simply more difficult to say that the Secretary has acted arbitrarily if he is authorized

to act "when he considers it necessary ...' than it is if he is required to act whenever a court

determinesthat certain objective conditions are met") (emphasisin original). Applying this standard,

we conclude that the Secretary did not act arbitrarily and capriciously in abandoning the Center's

Agent OrangeStudyafter determining, inview ofthe available reports,studies and recommendations,

that it was unlikely to produce scientifically valid conclusions about the long-termeffects of exposure

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to Agent Orange and other herbicides on Vietnam veterans' health. 1979 Act § 307(a)(3), (c).

The information available to the Secretaryindicated that fromitsinception, theCenter'sAgent

Orange Studywas confronted with identification difficultiesthat persisted through an additional pilot

study and completion of the TCDD study. The Center's Health Study Protocol anticipated that its

records-based method of exposure assessment might require "modification, indeed even a

recommendation not to proceed with an Agent Orange study...." Health Study Protocol at 11. The

initial review of military records confirmed the Center's concern that it might not succeed in

identifying cohorts of veterans who faced a greater likelihood of exposure to Agent Orange and other

herbicides than comparable cohorts of their peers and thus would have no way of distinguishing the

health effects of exposure to Agent Orange or other herbicides, as needed for an epidemiological

study. The congressional OTA and the President's Working Group supported this assessment. The

pilotstudy, which theCenter commissioned to evaluate its exposure assessment methods, highlighted

the inexactitude in the military records and revealed not onlythat unit dispersion and inadequate spray

records made classification difficult, but also that most veterans (other than the Ranch Hands) never

had the opportunity for significant Agent Orange exposure. The TCDD validation study, in turn,

confirmed that the military records-based assessments bore no relationship to current (and therefore

past) levels of Agent Orange in veterans' blood. With the evidence suggesting that the military

records did not provide accurate exposure indices, and with no evidence that an alternative method

existed to identify a sufficient number of veterans who were likely exposed to Agent Orange or other

herbicides, the Secretary could reasonably conclude, in concurrence with the Center, OTA, and the

Working Group, that the originally planned epidemiological Agent Orange Study was infeasible.

The fact that the TCDD study left open the possibility that military records might accurately

identify exposed veterans at low levels of exposure does not alter this conclusion. Because the

purpose of the TCDD study wasto validate the records-based exposure indices, the study, while not

ruling out the possibility that military records provided accurate exposure indices at low levels of

exposure, did not provide the verification of low-level exposure indices that the Center, OTA, and

the Working Group had deemed necessary to justify a cohort study using military records.

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16Appellants also rely on a statement in the 1986 Science Subpanel report that it "felt that an

additional method to verify exposure is required" as indicating that the Secretary acted on the

basis of amorphous "feelings" rather than evidence in the record. The Secretary, however, based

his conclusion that an exposure verification method was necessary on more than the Science

Subpanel's "feelings." OTA had similarly concluded that, because of misclassification problems,

an independent method of exposure assessment or some means of verifying the records-based

exposure estimates was needed. In addition, the TCDD study, which post-dated the Science

Subpanel report, confirmed that military records did not give reliable estimates of exposure to

Agent Orange among ground troops and that most ground troops had never faced meaningful

exposure to Agent Orange or other herbicides. 

17Appellants proffer the affidavit of Dr. Zena A. Stein, who states that "[m]isclassification

problems, like those at issue in the [Center's] exposure study ... do not necessarily invalidate any

Appellants nevertheless fault the Secretary for his failure to determine precisely how much

misclassification inheres in the military records. According to appellants, the Science Subpanel

implicitly drew a line "on the epidemiological risk continuum" beyond which the degree of

misclassification made scientific validity unachievable.16 They maintain that Ethyl Corp. v. EPA, 541

F.2d 1, 38-40 (D.C. Cir. 1976), and other cases require the Secretary to make this line explicit and

to support his determinationwith evidence in the record. Ethyl, which involved an agency rule setting

a particular numerical value for acceptable blood lead levels, 541 F.2d at 38, offers little guidance

here. Whereas Ethyl addressed whether the agency had a rational basis for the chosen numerical

value, the question in these appeals is whether the Secretary had a rational basisfor determining that

no known method existed to verify whether the military records-based assessments differentiated

between exposed and non-exposed veterans in the way necessary for a cohort study. The TCDD

study was designed, in part, to accomplish what appellants charge the Secretary should have done:

determine the degree of correlation (and therefore the degree of misclassification) between military

records and TCDD exposure. As the TCDD study illustrates, the Secretary has no way of knowing

the precise degree of misclassification. The Secretary knows only that inaccuracies and imprecision

in the military records make it impossible to determine whether a particular group of veteransis more

likely to have been exposed to Agent Orange and other herbicides than a comparable cohort of their

peers. That he did not pursue still other alternatives, at best vaguely identified by appellants, does

not demonstrate that the Secretary acted unreasonably in concluding in February 1988 that the

Center's Agent Orange Study should be abandoned.17

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justification of the study." Affidavit at 6-7. Dr. Stein, however, concedes that "a valid study must

meet a minimum threshold of probability and comparability" between exposed and unexposed

cohorts with respect to the fact of exposure, amount and duration of exposure, and other personal

characteristics and influences that might affect individuals' health. Id. at 2-4. Significantly, Dr.

Stein does not criticize the methodology used by the Center in reviewing the military records, and

she acknowledges that misclassification might preclude a valid Agent Orange Study if "the

misclassification problems were much greater than anticipated and outlined in" the Health Study

Protocol. Id. at 7.

Nor does appellants' assertion that the National Academy of Sciences has now proposed

to conduct an Agent Orange Study based on military records discredit the Secretary's decision,

which was made several years before the Academy issued its preliminary proposal. Moreover, in

the single page from the proposal that appears in the record, the Academy acknowledges that it

"does not know whether the approach it proposes will prove valid or whether new methods will

identify a sufficient number of highly exposed Vietnam veterans for an epidemiologic study." 

National Academy of Sciences, Institute of Medicine, Veterans and Agent Orange: Health Effects

of Herbicides Used in Vietnam (1993). This is hardly a criticism of the Secretary's approach, let

alone the identification of a fundamental flaw in the studies and conclusions on which the

Secretary relied. 

For these reasons we conclude that appellants have failed to show that when the Secretary

made his decision, after extensive efforts to identify and classify the data required for an

epidemiological study that focused solely on the long-term health effects of dioxin exposure, the

Secretary acted unreasonably or contrary to law in abandoning the Center's Agent Orange Study. To

the extent that Vietnam veterans as a group faced higher exposure to Agent Orange and other

herbicides than other groups of veterans, the Center's Vietnam Experience and Selected Cancers

Studies were designed, in part, to detect health effects that may have resulted from such exposure.

In addition, the Air Force's Ranch Hands study was examining the one group of veterans who faced

heavy exposure to Agent Orange and other herbicides. Based on the data available to the Secretary

in February1988, however, the Secretarycould reasonably conclude that it wasimpossible to identify

groups of Vietnam veterans who were similar except for their levels of dioxin exposure, as required

for the cohort tests necessary to ascertain the health effects of dioxins through a scientifically valid

Agent Orange Study.

Accordingly, because appellants have failed to present a material issue of fact or to

demonstrate that appellees were not entitled to judgment as a matter of law as to whether the

Secretary's decisionwas arbitrary, capricious, an abuse of discretion, or otherwise contraryto the law,

we affirm the grant of summary judgment to appellees.

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