Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-caDC-95-05058/USCOURTS-caDC-95-05058-0/pdf.json

Nature of Suit Code: 895
Nature of Suit: Freedom of Information Act of 1974
Cause of Action: 

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United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued May 10, 1996 Decided July 2, 1996

No. 95-5058

ROBERT A. BURKA,

APPELLANT

v.

UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES; PUBLIC HEALTH SERVICE; THE

NATIONAL INSTITUTES OF HEALTH; NATIONAL CANCER INSTITUTE,

APPELLEES

Appeal from the United States District Court

for the District of Columbia

(No. 92cv02636)

Robert A. Burka, appearing pro se, argued the cause for appellant, with whom Jack L. Lahr and

Lawrence M. Sung were on the briefs.

Richard M. Friedman, Counsel, pro hac vice, United States Department of Health and Human

Services, argued the cause for appellees, with whom Eric H. Holder, Jr., United States Attorney, R.

Craig Lawrence and Michael J. Ryan, Assistant United States Attorneys, were on the brief. Susan

A. Nellor, Assistant United States Attorney, entered an appearance.

Before: WALD, BUCKLEY and SENTELLE, Circuit Judges.

Opinion for the court filed by Circuit Judge WALD.

WALD, Circuit Judge: Between December, 1991 and August, 1992, appellant Robert Burka

filed several Freedomof Information Act ("FOIA" or "Act") requests with the Department of Health

and Human Services ("HHS" or "agency") seeking information related to smoking behavior. The

agency disclosed some of the documents Burka sought, but withheld data from a comprehensive

study of how community-based interventions affect smoking habits. Burka then filed suit in federal

court challenging the agency's decision to withhold the research material. On remand from an earlier

round in this court, the district court granted the agency's motion for summary judgment, ruling that

the materials sought by Burka were exempt from FOIA disclosure under Exemption 5 of the Act as

"confidential research information." Burka now seeks reversal of the district court's decision. As

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explained below, Exemption 5 allows an agency to refuse disclosure of records "not available by law

to a party ... in litigation with the agency." We find that the material sought by Burkacomputer

tapesrecording survey responses about smoking habits and attitudes, as well as paper questionnaires

on the same topicis not generally protected in civildiscoverybecause ofits nature, and so conclude

it does not fall under the protection of Exemption 5. Accordingly, we reverse the grant of summary

judgment to HHS and remand to the district court for further proceedings.

I. BACKGROUND

Before considering whether the agency properly withheld the the information requested, we

explain exactly what material Burka sought from HHS, and how the agency and district court

responded.

A. The "COMMIT" Study

1. Study Goals, Design, and Implementation

The data sought by Burka was compiled during an extensive study of smoking behavior

conducted from 1986 to 1993 by the National Cancer Institute ("NCI"), a division of HHS' National

Institutes of Health. NCI initiated this project, called the Community Intervention Trial for Smoking

Cessation Study ("COMMIT" or "study"), in order to assess the effectiveness of community-based

anti-smoking efforts. COMMIT represented a significant investment of $45 million by NCI, see

Editor's Foreword, 11 INT'L Q. COMMUNITY HEALTH EDUC. 169 (1991), reprinted in App. at 189,

which described it as "the most comprehensive planning, implementation and evaluation effort to

reduce smoking through community approaches attempted to date." Lawrence Wallack & Russell

Sciandra, Media Advocacy and Public Education in the Community Intervention Trial to Reduce

Heavy Smoking (COMMIT), 11 INT'LQ. COMMUNITY HEALTH EDUC. 205, 206 (1991), reprinted in

App. at 221, 222.

COMMIT was designed to test two related hypotheses: first, that smoking behavior is

significantly shaped by social circumstances and pressures, and second, that using community sites

such asschools, workplaces, and health care offices as the locus for anti-smoking efforts will induce

people to alter their smoking behavior. Lichtenstein, et al., Introduction to the Community

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Intervention Trial for Smoking Cessation (COMMIT), 11 INT'LQ.COMMUNITY HEALTH EDUC. 173,

175 (1991),reprinted in App. at 191, 193; Thompson, et al., Principles of Community Organization

and Partnership for Smoking Cessation in the Community Intervention Trial for Smoking Cessation

(COMMIT), 11 INT'LQ.COMMUNITY HEALTH EDUC. 187, 188-89 (1991), reprinted in App. at 204,

205-06; Thompson, et al., Community mobilization for smoking cessation: lessons learned from

COMMIT, 8 HEALTH PROMOTION INT'L 69, 70 (1993), reprinted in App. at 363, 364. In eleven

different locations acrossthe United States andCanada, theCOMMIT teampaired communities with

similar demographic profiles, mobility and migration patterns, urbanization rates, numbers of work

sites, estimated smoking rates, and access to various channels for community-based intervention

efforts. COMMIT Research Group, Community Intervention Trial for Smoking Cessation

(COMMIT): Summary of Design and Intervention, 83 J. NAT'L CANCER INST. 1620, 1621 (1991),

reprinted in App. at 178, 179. One community in each pair was randomly selected to participate in

a concentrated smoking cessation campaign, and the other community was used as a control for

comparison purposes. In each of the eleven communities targeted for intervention, COMMIT

researchers conducted 4 years of smoking cessation efforts at localschools, workplaces, and health

care provider offices, as well asthrough the mass media. Id. at 1620-21,reprinted in App. at 178-79.

To measure the effectiveness of these cessation programs, COMMIT researchers developed

survey tools to measure smoking behavior both before and after the intervention efforts. Prior to

launching the cessation programs, the researchers conducted two "before" polls of smoking habits

in each of the eleven pairs of communities(22 communitiestotal) to obtain baseline data. In the first

survey, conducted in 1988, COMMIT researchers asked adults about their demographic

characteristics, smoking status, current and past smoking behavior, use of tobacco products other

than cigarettes, attitudes and knowledge about smoking, and other health-related information. First

Decl. of Dr. Edward J. Sondik ¶ 17, reprinted in App. at 120, 125 [hereinafter "First Sondik Decl."].

In the second "before" survey, two years later, the COMMIT team asked approximately 8,000

ninth-grade students to complete a lengthy written questionnaire regarding their current and past

smoking habits, as well as a range of other topics related to influences which might affect their

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1The written questionnaire asked students about their current and past smoking habits, where

they purchased cigarettes, whether price increases would affect their purchase of cigarettes, their

use of other tobacco products, the smoking habits of their friends, their exposure to tobacco

advertising, the presence of anti-smoking programs and policies in their schools, their knowledge

and attitudes about smoking, and the attitudes towards smoking of their parents, friends, and

teachers. See First Sondik Decl. ¶ 20; COMMIT Youth Survey, reprinted in App. at 147-67. 

2Although Burka's initial FOIA requests might be interpreted as including these follow-up

responses, in his final request to the agency and in his briefs to the district court and this court, he

clarified that he now seeks only the baseline data collected prior to the COMMIT intervention

efforts. Thus, the follow-up responses are not at issue in this appeal. 

smoking behavior.1Id. WW 19-20. The researchers then engaged in various intervention efforts at

a range of different community locations, and surveyed the same populations afterwardsto determine

how the cessation efforts had affected their smoking habits.2 Memorandum & Order, No. 92-2636,

at 4 (D.D.C. Feb. 10, 1995), reprinted in App. at 10, 13 [hereinafter "1995 Mem. & Order"].

Ratherthan coordinating the collection and analysis ofthis data itself, NCI contracted out this

task to Information Management Systems ("IMS"). See NCI/IMS Contract, reprinted in App. at

406-13; Plaintiff's Statement of Material Facts Not in Dispute ¶ 4, reprinted in App. at 446, 447;

Defendant's Response to Plaintiff's Statement of Material Facts ¶ 4, reprinted in App. at 451.

According to NCI and IMS, two other firms actually conducted the adult phone survey and created

computer tapes of the results, and then turned over these tapes to IMS. First Sondik Decl. ¶ 21;

First Decl. of Janis A. Beach, WW 3-4 reprinted in App. at 84, 85 [hereinafter "First Beach Decl."].

Various research institutions collaborating on the COMMIT project collected the paper

questionnaires and turned them over to IMS as well. Id. IMS transferred these results to computer

tapes, which it still hasin its possession, id., and transmitted the paper questionnaires to NIH, where

they are currently stored in a federalrecords center, First Sondik Decl. ¶ 23; First Beach Decl. ¶ 11.

2. Publications by COMMIT Researchers

One of the central goals of the COMMIT project is the publication of research results. For

example, members of the COMMIT team have already published several articles based solely on the

baseline dataone concerning the methodology developed by the team for measuring

community-wide behavior changes, see Gail, et al., Aspects of Statistical Design for the Community

Intervention Trial for Smoking Cessation (COMMIT), 13CONTROLLEDCLIN.TR. 6 (1992),reprinted

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3

In December of 1991, Burka submitted a FOIA request for "[a]ll documents constituting,

referring or relating to cigarette/tobacco advertising targeted at specific age groups of actual or

potential consumers of tobacco products and the effects of such advertising on brand recognition,

loyalty and market share among different age groups." Burka FOIA Request of 12/19/91,

reprinted in App. at 42-44. The agency released a number of documents and notified Burka that

in App. at 327, and several others discussing the smoking rates in various test communities and

across various demographic categories,see, e.g., Mattson, et al., Evaluation Plan fortheCommunity

Intervention Trial for Smoking Cessation (COMMIT), 11 INT'LQ.COMMUNITY HEALTH EDUC. 271

(1991), reprinted in App. at 284; Sorensen et al., Promoting Smoking Control Through Worksites

in the Community Intervention Trial for Smoking Cessation (COMMIT), 11 INT'L Q. COMMUNITY

HEALTH EDUC. 239 (1991), reprinted in App. at 254. Still another article discusses the purchasing

habits of teen smokers, see Cummings, et al., Where teenagers get their cigarettes: a survey of the

purchasing habits of 13-16 year olds in 12 US communities, 1 TOBACCO CONTROL 264 (1992),

reprinted in App. at 323. The research team has also published other articles which compare the

baseline and follow-up data and draw conclusions about the use of various resources for quitting

smoking, as well as other factors which might affect the likelihood that a particular segment of the

populationwill quit smoking,see, e.g., Pomrehn, et al., Enhancing Resourcesfor SmokingCessation

Through Community Intervention: COMMIT as a Prototype, 11 INT'L Q. COMMUNITY HEALTH

EDUC. 259 (1991), reprinted in App. at 273; Royce, et al., Smoking Cessation Factors among

African Americans and Whites, 83 AM.J. PUB. HEALTH 220 (1993), reprinted in App. at 356. The

agency has stated that the COMMIT team plans to publish a total of 11 additional reports, see Br.

for Appellee at 33 n.12, although when asked at oral argument, counselfor the government could not

provide a specific time line for publication. Nor has the agency provided us with information about

the topics of these proposed articles, other than to assert that they will "disseminate the results of the

project." Id. at 32; see also First Sondik Decl. ¶ 29 (reports will present "the results and conclusions

from the project").

B. Burka's FOIA Requests

After filing two FOIA requests in 1991 and 1992 seeking information relating to cigarette

advertising,3on August 31, 1992, Burka filed his third and final FOIA request, seeking "all

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it was withholding other responsive materials under FOIA Exemptions 5 and 6, but did not

specifically mention the existence of the COMMIT data tapes or questionnaires. HHS Response

Letters of 1/7/92, 3/2/92, and 3/13/92, reprinted in App. at 45-52. In the meantime, an HHS

publication printed an article summarizing some of the baseline COMMIT data on brand selection

among adults and teenagers, several other articles regarding the effect of cigarette advertising on

children appeared in other publications, and the Surgeon General made public remarks on the

same topic. See, e.g., CDC MORBIDITY AND MORTALITY WEEKLY REPORT, reprinted in App.

348-55; Glenn Ruffenach, Study Says Teen-Agers' Smoking Habits Seem to Be Linked to Heavy

Advertising, WALL ST. J., Mar. 13, 1992, at B8, reprinted in App. at 347; Suggested Remarks for

Antonia Novello, M.D., Surgeon General of the Public Health Service, at the AMA Press

Conference on "Old Joe" Advertising, Mar. 9, 1992, reprinted in App. at 343-46. Burka then

filed a second, more specific FOIA request on March 25, 1992 referencing these articles and the

COMMIT study, and on April 10, 1992, appealed the denial of his first request. Burka FOIA

Request of 3/25/92, reprinted in App. at 53-57; Burka Appeal of Denial of FOIA Request,

reprinted in App. at 58-62. The agency, in turn, provided several additional documents related to

"Old Joe Camel" advertising, upheld denial of a relevant memorandum pursuant to Exemption 5,

and stated that there were no further responsive records. HHS Response Letter of July 8, 1992,

reprinted in App. at 63-64. Several months later, it also released copies of the COMMIT

contracts and protocol. First Burka Decl. ¶ 13, reprinted in App. at 91, 95. 

questionnaires and data tapes relating to the National Cancer Institute 1990 survey of ninth-grade

students undertaken as part of the [COMMIT] study." Burka FOIA Request of 8/31/92, reprinted

in App. at 65-66. The agency refused to give him this material. It acknowledged that while it had

the written questionnaires in its possession, it was withholding them under Exemptions 4 and 5 of

FOIA; as to the tapes, the agency stated only that they were in possession of IMS. HHS Response

Letter of 9/4/92, reprinted in App. at 67-68.

After the agency denied his administrative appeal, see Second Burka Decl. ¶ 3, reprinted in

App. at 99-100, Burka filed suit in district court. Abandoning his quest for other materials related

to cigarette advertising, he challenged the agency's decision to withhold only three specific items: the

written questionnaires completed by ninth-graders in 1990; the computer data tape containing the

results of these questionnaires; and the computer data tape containing the results of the 1988 adult

phone survey. Compl. for Injunctive Relief ¶ 9, reprinted in App. at 31, 34. The government

continued to oppose disclosure, arguing that the data tapes were not "agency records" covered by

FOIA, and that even if they were, both the tapes and written questionnaires were protected under

Exemptions 4, 5, and 6.

Adopting the government's position in part, the district court first noted that an agency

document is covered by Exemption 5 if not "routinely discoverable by an agency's opponent upon a

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showing of relevance in a civil action." Memorandum, No. 92-2636 at 8 (D.D.C. Dec. 13, 1993)

[hereinafter "1993 Mem."]. The court further stated that defendants had cited "ample authority" for

the proposition that confidentialresearch material may be protected in the context of civil discovery.

The remaining question, the court found, was whether or not the specific information sought by

Burkathe questionnaires and tapeswould be fairlycategorized as "confidentialresearchmaterial"

if the agency attempted to shield it in civil discovery proceedings. It concluded that the agency had

identified two interests which would trigger protection of the material in discovery: 1) interference

with ongoing scientific research, which could occur if the data was released prior to the follow-up

surveys, and individuals then modified their behavior or survey answers in response to this

information; and 2) harm to "the COMMIT researchers' interest in having their research published

in prestigious, peer-reviewed journals," which the agency claimed would result if any study data was

disclosed prior to release ofthe remaining articlesslated for publication. Id. at 8-9. Accordingly, the

court granted summary judgment for the agency, ruling that although the questionnaires and data

tapes were "agency records" for purposes of FOIA, they could be withheld under Exemption 5.

Burka appealed that decision to our court, and before oral argument, filed a motion to

supplement the record with twelve additional publications allegedly containing data related to the

COMMIT study. 1995 Mem. & Order at 4-5. This court remanded the case to the district court for

consideration of Burka's supplemental request. Order, No. 94-5003 (D.C. Cir. June 15, 1994) (per

curiam). On remand, the district court granted the motion to supplement the record and proceeded

to resolve the case on the merits. Leaving undisturbed its conclusion that the requested information

constituted "agency records" subject to FOIA, the court considered whether the materialwas exempt

from disclosure. It first determined that since the COMMIT research had been concluded during the

time between the district court's initial ruling and the remand, the government's interest in avoiding

a skewing of the research results was no longer relevant. 1995 Mem. & Order at 4. The court then

turned to the government'sinterest in publishing the COMMIT resultsin prestigiousjournals, finding

that even though some oftheCOMMIT data had been made public via the additional articlesincluded

in the motion to supplement, this partial disclosure did not vitiate the researchers' interest in keeping

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confidential the remainder of the data until they had published the rest of the proposed articles. It

concluded that "[t]hose interests [in publication] still render the data "confidential research

information' within the meaning of Rule 26(c)(7) and hence, justify exempting the data from

disclosure under FOIA exemption 5." Id. at 8.

Burka now seeks reversal of the district court's grant of summary judgment for the

government. He advances several arguments in support of his claim that Exemption 5 is inapplicable.

While appearing to maintain, at times, that Exemption 5 incorporates only a limited number of

privileges (deliberative material, attorney/client communications, work product, and confidential

commercial information), Burka acknowledges elsewhere that the provision encompasses all

well-recognized civil discovery protections. He claims, however, that the rules of civil discovery

recognize neither a blanket protection of confidential research information, nor a more tailored

protection which might be invoked to prevent premature disclosure of research data if disclosure

would harm the researcher's opportunities for publication. Alternatively, he argues that even if

confidential research data may be shielded in discovery to protect a researcher's publication

opportunities, the government has not adequately explained how disclosure of the COMMIT tapes

and questionnaires would harm that interest and thus has not demonstrated that this material would

be protected in discovery. Not surprisingly, the government takes a contrary position on both points,

asserting that confidential research data is a category of information protected in civil discovery

proceedings, and that the specific records sought byBurka would be eligible for such protection and

may therefore be withheld in the FOIA context, as well.

II. ANALYSIS

Having detailed the type ofinformation sought byappellant Burka and the tortuouslegal path

his FOIA request hastaken, we reach the question of whether the agency appropriately withheld the

COMMIT questionnaires and data tapesa query answered in the affirmative by the district court

in granting summary judgment for HHS. It is well established that summary judgment is appropriate

where, viewing the facts in the light most favorable to the non-moving party, no genuine issue of

material fact remains. FED. R. CIV. P. 56(c); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249

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4HHS does not contest Burka's position that the COMMIT questionnaires are agency records

for purposes of FOIA. 

(1986). We review de novo a district court's grant of summary judgment for an agency in a FOIA

case. Nation Magazine v. U.S. Customs Service, 71 F.3d 885, 889 (D.C. Cir. 1995) (citing Steinberg

v. United States Dep't of Justice, 23 F.3d 548, 551 (D.C. Cir. 1994)), though "mindful that the

"burden is on the agency' to show that requested materialfalls within a FOIA exemption." Petroleum

Information Corp. v. U.S. Dep't of Interior, 976 F.2d 1429, 1433 (D.C. Cir. 1992) (quoting 5 U.S.C.

§ 552(a)(4)(B) and citing Anderson, 477 U.S. at 254).

A. COMMIT data tapes are "agency records" for purposes of FOIA

To qualify as an "agency record" subject to FOIA disclosure rules, "the agency must "either

create or obtain' the requested materials," and "the agency must be in control of [them] at the time

the FOIA request is made." Dep't of Justice v. Tax Analysts, 492 U.S. 136, 144 (1989) (quoting

Forsham v. Harris, 445 U.S. 169, 182 (1980)). HHS suggests that the COMMIT data tapes4do not

satisfy these requirements because they were neither created by agency employees, nor are they

currently located on agency property. The district court disposed of this argument in its 1993 ruling,

and we now affirm its persuasive analysis on this point. See 1993 Mem. at 3-7. While the mere fact

that the firms which created the 1988 data tapes, as well as IMS, which created the 1990 tapes and

now possesses both sets of tapes, received federal funds to finance the research would not be

sufficient to conclude the data were "created or obtained" by the agency, see Forsham, 445 U.S. at

177, the extensive supervision and control exercised by the agency over collection and analysis ofthe

data indicates that these firms acted on behalf of HHS in creating the tapes. As to the second prong

of the Tax Analyststest, this circuit has identified four factorsrelevant to a determination of whether

an agency exercises sufficient control over a document to render it an "agency record": "(1) the

intent of the document's creator to retain or relinquish control over the records; (2) the ability of the

agency to use and dispose of the record as it sees fit; (3) the extent to which agency personnel have

read or relied upon the document; and (4) the degree to which the document was integrated into the

agency's record system or files." Tax Analysts v. Dep't of Justice, 845 F.2d 1060, 1069 (D.C. Cir.

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5

In fact, it is not clear from the government's brief whether it contests on appeal Burka's claim

that the agency exercised constructive control over the records at the time appellant's FOIA

request was filed. 

6

In relevant part, Rule 26(c) provides:

Upon motion by a party or by the person from whom discovery is sought, ... for

1988) (citation omitted), aff'd on other grounds, 492 U.S. 136 (1989). NCI ordered creation of the

materials, plansto take physical possession ofthe tapes at the conclusion of the project, hasindicated

it will disclose the information after its publication schedule is completed and prohibited IMS from

making anyindependent disclosures, and hasread and relied significantlyon the informationinwriting

articles and developing agency policies. As did the district court, we find these actions sufficient to

conclude that HHS had constructive control of the tapes at the time Burka filed his FOIA requests.5

Since Burka has adequately demonstrated that both prongs ofthe Tax Analyststest are satisfied here,

the tapes must be treated as "agency records" for purposes of FOIA.

B. Scope of Exemption Five

Because FOIA establishes a strong presumption in favor of disclosure, see S. REP. No. 813,

89th Cong., 1st Sess. 3 (1965), requested material must be disclosed unless it falls squarely within

one of the nine exemptions carved out in the Act. United States Dep't of Justice v. Julian, 486 U.S.

1, 8 (1988) (citing United States v. Weber Aircraft Corp., 465 U.S. 792 (1984)); see also Petroleum

Info. Corp., 976 F.2d at 1433 (summary judgment in favor of FOIA plaintiff appropriate if agency

seeks to protect information that falls outside proffered exemption). Thus, HHS may withhold the

agency records sought by Burka only if they fall under an applicable exemption. The agency

contended, and the district court agreed, that Exemption 5, which removes from FOIA's reach

"inter-agency or intra-agencymemorandums or letters which would not be available bylaw to a party

... in litigation with the agency," 5 U.S.C. § 552(b)(5) (1994), would fill that bill. In support of this

position, HHS draws our attention to FederalRule of Civil Procedure 26(c)(7), which allows a court

to issue a protective order in civil discovery mandating that "a trade secret or other confidential

research, development, or commercial information not be revealed or be revealed only in a

designated way." FED.R. CIV. P. 26(c)(7) (emphasis added).6 The agency argues that the type of

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good cause shown, the court in which the action is pending ... may make any order

which justice requires to protect a party or person from annoyance,

embarrassment, oppression, or undue burden or expense, including one or more of

the following:

... (7) that a trade secret or other confidential research, development, or

commercial information not be revealed or be revealed only in a designated way.

FED.R. CIV. P. 26(c). 

7For example, presentence investigation reports requested by the prisoner himself are routinely

available in discovery to the subject of the report and thus not within Exemption 5's purview. 

Julian, 486 U.S. at 12-13. 

information sought by Burka would be shielded under this provision as "confidential research

information," and thusthe materialis not "routinelydiscoverable." Accordingly, the agency contends,

the COMMIT tapes and questionnaires may be withheld under Exemption 5. We now examine this

claim.

As indicated by its language, the parameters of Exemption 5 are determined by reference to

the protections available to litigants in civil discovery; if material is not "available" in discovery, it

may be withheld from FOIA requesters. FOIA's legislative history expressly mentions three types of

material which fall within the exemption's protective scope: predecisional deliberative memoranda,

see, e.g., EPA v. Mink, 410 U.S. 73, 87-92 (1973); Petroleum Info. Corp., 976 F.2d at 1434;

Coastal States Gas Corp. v. Dep't of Energy, 617 F.2d 854, 866 (D.C. Cir. 1980); Mead Data

Central, Inc. v. Dep't of Air Force, 575 F.2d 932 (D.C. Cir. 1978); Montrose Chem. Corp. v. Train,

491 F.2d 63 (D.C. Cir. 1974); attorney-client communications, see, e.g., Schlefer v. United States,

702 F.2d 233 (D.C. Cir. 1983); and attorney work product, see, e.g., FTC v. Grolier, Inc., 462 U.S.

19 (1983); NLRB v. Sears, Roebuck & Co., 421 U.S. 132, 154 (1975); Coastal States Gas Corp.,

617 F.2d at 864-65. Yet as the government reminds us (and Burka concedes, as he must), Exemption

5 is not confined to these three privileges. Instead, it incorporates other generally recognized civil

discovery protections. If a document requested through FOIA "would be "routinely' or "normally'

disclosed [in civil discovery] upon a showing of relevance," it must also be disclosed under FOIA7;

conversely, information which isroutinely protected in discovery falls within the reach of Exemption

5. Grolier, 462 U.S. at 26.

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8Cf. Julian, 486 U.S. at 11 (Exemption 5 is a "somewhat Delphic provision"); Martin v.

Office of Special Counsel, 819 F.2d 1181, 1184 (D.C. Cir. 1987) ("the exact relationship between

ordinary civil discovery and Exemption (b)(5), particularly the application of discovery privileges

under the exemption, has bedeviled the courts since the Act's inception"). 

9Grolier, decided the year before Weber, offers some additional insight on when a civil

discovery protection is "well-settled." 462 U.S. at 26. There, the Supreme Court ruled that

Exemption 5 protected work-product materials even after the termination of litigation, concluding

that material is not "routinely available" if a majority of the circuits have categorized it as

privileged in the context of discovery: "all of the courts of appeals that had decided the issue ...

[and] an overwhelming majority of the federal district courts reporting decisions ... were in accord

with that view." Id. While not tabulating the "yeas" and "nays," the court cited cases from five

circuits, six district courts, and several state courts in accord with its holding, and no cases to the

contrary. 

Deciding which ofthese two categories better describesinformation that issometimessubject

to a protective order, but in other circumstances disclosed, is not an easy task.8 Precedent suggests

that Exemption 5 applies to any material mentioned in FOIA's legislative history, as well as

informationwhich is not routinelydisclosed in discoverybecause it has been accorded a "well-settled"

or "well-recognized" protection. In considering whether the "Machin privilege," which protects

confidentialstatements made during air crash safety investigationsfrom discovery, wasincorporated

in Exemption 5, the Supreme Court explained in Weber:

It is one thing to say that recognition under Exemption 5 of a novel privilege, or one

that hasfound lessthan universal acceptance, might not fallwithin Exemption 5 if not

discussed in itslegislative history. It is quite another to say that the Machin privilege,

which has been well-settled for some two decades, need be viewed with the same

degree of skepticism.

465 U.S. at 801. The court concluded that "since the Machin privilege is well recognized in the case

law as precluding routine disclosure of the statements, the statements are covered by Exemption 5."9

Id. at 799 (emphasis added). Cf. Martin, 819 F.2d at 1185 (Exemption 5 incorporates "all civil

discovery rules," rather than only those related to the executive deliberative process privilege).

Both parties agree that in several contexts, courts have exercised their authority under Rule

26(c)(7) to shield from discovery confidential research informationincluding raw data developed

by researchers. See Br. for Appellant at 31; Br. for Appellee at 18; see also infra n. 13 (listing

cases). Based on these cases, the agency would have us conclude that courts have generally

recognized a protection for this type of informationa protection sufficient to bring all confidential

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10For a similar point, see Anderson v. Dep't of Health & Human Services, 907 F.2d 936, 945-

46 (10th Cir. 1990). There, the court rejected a claim that Exemption 4 of FOIA, which protects

"trade secrets and commercial or confidential information" provided to an agency by a private

party, extends to all materials subject to protective order under Rule 26(c)(7). Recognizing that

courts may issue protective orders imposing varied restrictions, for a wide range of reasons, the

Tenth Circuit concluding that shielding all material covered by some type of protective order from

FOIA disclosure would be an overly broad reading of the exemption: "It cannot be argued

seriously that a Rule 26(c)(7) order merely limiting production of certain documents to a specified

place renders those materials privileged for FOIA purposes." Id. at 946. 

research information within Exemption 5. We do not think, however, that these discovery decisions,

taken alone, would justify a decision to extend protection to this entire category of information in the

FOIA context. The decision to limit or deny discovery by means of a Rule 26 protective order rests

on a balancing of variousfactors: the requester's need for the information from this particular source,

itsrelevance to the litigation at hand, the burden of producing the sought-after material; and the harm

which disclosure would cause to the party seeking to protect the information. Federal Open Market

Comm. of the Fed. Reserve Sys. v. Merrill, 443 U.S. 340, 362-63 (1979); see also WRIGHT ET AL.,

FEDERAL PRACTICE AND PROCEDURE § 2043 (1994) (explaining balancing test for issuance of Rule

26 protective order). Yet several of these criteria are not pertinent in the FOIA context; relevance

and need mean nought, since by statute a FOIA requester need not disclose either, and any

burdensomeness of a request is accounted for in other provisions of the FOIA statute. See Merrill,

443 U.S. at 362. Moreover, under this standard it will almost always be possible to identify some

combination of circumstances under which requested information may appropriately be the subject

of a protective order. Even though a court might generally permit discovery of a particular

document, it may deny discovery in a case where the information is not particularly relevant or

necessary to the requester's ability to present his case. Thus, if we simply look at whether the agency

can identify any cases extending a protective order to a certain category of information, the answer

will usually be "yes." If Exemption 5 is triggered every time an agency can point to such cases, the

exception carved out of FOIA's overarching policy of disclosure will quickly swallow up the rule.10

We are inclined to the view that to justify non-disclosure under Exemption 5, an agency must show

that the type of material it seeks to withhold is generally protected in civil discovery for reasons

similar to those asserted by the agency in the FOIA context.

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11In deciding that Exemption 5 included confidential commercial information which would be

protected in discovery, the Merrill Court also relied on the oblique reference in a House Report

to the need to withhold information generated in the process of awarding a contract. See Merrill,

443 U.S. at 357-59. The Court subsequently made clear, however, that if a civil discovery

protection is not a novel one (i.e., if it is "well-recognized"), it may be incorporated in Exemption

5 even if not mentioned in FOIA's legislative history. See Weber, 465 U.S. at 800-01. 

12In Merrill, only one reason (harm to an entity's competitive financial position) was advanced

for protecting confidential commercial information from discovery. By contrast, other case law

regarding confidential research information suggests several reasons to shield this material from

disclosure, e.g., patient confidentiality, continued viability of a research project, and researchers'

publication opportunities. To give force to the Court's insistence in Weber and Grolier that a

protection be generally accepted in civil discovery before it is incorporated into Exemption 5, we

think that an agency must show not only that the interest asserted in support of non-disclosure has

been relied upon to justify issuance of a protective order, but that protection based on that interest

is more than a "novel" occurrence. 

This approach accords with the Supreme Court's assessment ofthe relationship betweenRule

26(c) and Exemption 5. In Merrill, the Court faced the question of whether financial reports

generated by the Federal Reserve Board could be temporarily withheld to avoid potentially

deleterious effects on the price of government bonds. It noted that Rule 26(c)(7) permits courts to

protect confidential commercial information from discovery.11 Yet it was not enough, the Court

determined, for the agencyto simplydemonstrate that the reportsit sought to withhold fellwithin this

category. The Federal Reserve was also required to show, on remand, that the specific interest which

justifies issuance of a protective order for this type of materialharm to the financial position of the

entity which holds the informationwas implicated by the FOIA request. See Merrill, 443 U.S. at

363 ("the sensitivity of the commercial secrets involved, and the harm that would be inflicted upon

the Government by premature disclosure, should continue to serve asrelevant criteria in determining

the applicability of this Exemption 5 privilege"). Likewise, we find it insufficient for HHS merely to

categorize the COMMIT data as "confidential research information." To prevail, it must persuade

us that the interest which it identifies as warranting protection in civil discoverythe researchers'

publication opportunitiesis both a generally recognized ground for shielding the material from

discovery12 and actually implicated by Burka's request.

Our interpretation ofthe scope ofExemption 5 squares with the generalstructure of Rule 26.

The rule allows litigants to obtain discovery "regarding any matter, not privileged, which is relevant

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to the subject matter involved in the pending action." FED. R. CIV. P. 26(b)(1). Privileged

information, then, is presumptively not discoverable. In addition, the rule shields work product

prepared in anticipation oflitigation fromdisclosure, unlessthe partyseeking discoverydemonstrates

"substantial need" for the materials,see FED.R.CIV.P. 26(b)(3), as well as protecting fromdiscovery

expert witnesses not expected to testify at trial, except where a party can show "exceptional

circumstances" which make it "impracticable" to obtain information on the subject by other means,

see FED. R. CIV. P. 26(b)(4). Material which falls outside these categories is presumptively

discoverable, although a court may issue a protective order limiting or denying discovery "for good

cause shown," to protect from"annoyance, embarrassment, oppression, or under burdenor expense."

FED.R.CIV.P. 26(c). Such an order may, inter alia, deny discovery completely; limit the conditions,

time, place, or topics of discovery; or limit the manner in which a trade secret or other confidential

research, development, or commercial information may be revealed. Id. Translating this two-tiered

arrangement into the FOIA context means that merely identifying information as falling within a

privileged categorydeliberativematerial, attorney- client communications, work productmaybe

sufficient to withhold the material from a FOIA requester. When dealing with information withheld

on the groundsthat it may be subject to a protective order, though, something more isrequired: just

as the target of a discovery request must show "good cause" under Rule 26(c) to escape disclosure,

the agency claiming exemption from FOIA must identify an interest similar to one which courts have

found sufficient to justify the "good cause" standard in discovery proceedings.

C. Applying this Standard to HHS' Non-Disclosure of the COMMIT Data

The asserted government interest in non-disclosure of the COMMIT data is that the

COMMIT researchers and NCI want to publish their results in prestigious, peer-reviewed journals.

By doing so, they can present their findings in a forum which commands professional respect and

enhances their credibility, and by inference strengthens the weight of any agency actions or policy

recommendations based on those findings. Unfortunately, the government has identified only one

case in which a federal court has granted a protective order based on that kind of interest, and our

own research has unearthed no others.

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Although we doubt initially that one federal case is sufficient to support the agency's claim

that the type of material sought by Burka is covered by Exemption 5, we naturally look to that

decision for the persuasiveness of its reasoning. In Dow Chemical Company v. Allen, the Seventh

Circuit considered whether research notes, reports, working papers, and raw data relating to ongoing

animal toxicity studies were discoverable by Dow, which planned to use the information at hearings

on the possible cancellation of its license for production of an herbicide. 672 F.2d 1262 (7th Cir.

1982). The district court declined to enforce a subpoena issued against the researcher, on the

groundsthat the probative value ofthe information was quite limited at that stage of the case; Dow's

need for the material was not overwhelming; and the subpoena was excessively burdensome. Id. at

1270-73. In affirming this ruling, the Seventh Circuit examined each of these interests. It agreed that

the research material lacked probative value because it could not be used by Dow to demonstrate the

safety of the herbicide product at issue, and was not of great need to Dow because neither the

researcher'stestimony nor evidence fromhisstudies would be introduced at the cancellation hearing.

Id. at 1272. On the other side of the protective order balancing test, the court identified several ways

in which discovery would impose a significant burden on the researcher. Citing affidavits

unchallenged by Dow, the court found that immediate public accessto the requested material would

deprive researchers of both the opportunity to have their results published by prestigious

peer-reviewed journals, as well as the professional benefits accompanying this achievement. Id. at

1273-74. It also determined that the researchers' interest in academic freedom would be chilled by

having to disclose all of their underlying raw data and notes. Id. at 1276-77. Since the harm to these

interests that might be caused by immediate disclosure of the research material outweighed Dow's

minimalrelevance and need for the material, the court concluded that the district court had not erred

in denying discovery.

The Seventh Circuit revisited this issue in Deitchman v. E.R. Squibb & Sons, Inc., where it

vacated and remanded a district court's order quashing a subpoena for research data on the

connection between the drug diethylstilbestrol ("DES") and cancer. 740 F.2d 556 (7th Cir. 1984).

Balancing the need for disclosure against any harm it might impose, the court found the burden of

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disclosure significant. The information soughta registry of patients suffering from vaginal

cancerwas a critical toolfor epidemiologicalresearch, and since it was obtained frompatients with

a promise of strict confidentiality, the continued viability of the registry could be severely

compromised by disclosure. Id. at 559-60. This concern, the court determined, could be sufficiently

addressed by conducting discovery in a manner which preserved confidentiality. Id. at 560. The

second interest asserted by the researcher in his effort to defeat the subpoena was similar to that

discussed in Dow: he wished "to divulge to the public the results of his studies only in his own time

and way." Id. Without exploring this issue, the court tersely acknowledged that it had previously

recognized an interest in protecting research material from premature disclosure: "We agree

arguendo that the [research materials] may enjoy a qualified privilege and are not to be pried into

unnecessarily." Id. at 560-61. On the other side of the scale, the Seventh Circuit found the

company's need for the data more compelling than had the district court; without discovery, it could

not review the study protocol for any flaws or biases. Id. at 563. Although remanding for issuance

of a protective order that addressed the need for patient confidentiality and reimbursement of

discovery expenses, the court indicated that discovery of material which did not reveal patient

identities or the researchers' as-yet unpublished conclusions (as compared with factual information

regarding, inter alia, study protocols, questionnaires, and statistical analyses) was appropriate. Id.

at 564-65.

The Second Circuit has also considered whether a researcher's interest in her data merited a

protective order, but declined to conclusively rule on this issue. In re American Tobacco Company,

880 F.2d 1520 (2d Cir. 1989). The district court there had ruled that under state law, a researcher

might have a cognizable interest in preventing disclosure of research data to protect her interest in

publishing those results, although the existence ofsuch a privilege was far from clear; the only state

court case which could be said to have recognized the privilege focused its attention on the burden

of the contested subpoena, and thus "it [was] possible that the court regarded the scholar's interest

in his research data as merely a factor to be taken into account in weighing the burdens of

production." Id. at 1528. The court of appeals eventually determined that even if such a privilege

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13The government cites other cases which grant or affirm issuance of a protective order for

confidential research information, but do so on grounds other than the nature of the information. 

See Deford v. Schmid Products Co., 120 F.R.D. 648, 654 (D. Md. 1987) (permitting discovery of

research data because researcher failed to demonstrate that disclosure of information would cause

harm); Harris v. Upjohn, 115 F.R.D. 191, 192 (S.D. Ill. 1987) (ordering production of reports

regarding adverse drug reactions but allowing redaction of the names of patients and physicians

from these reports, on grounds that patients will participate in research only if their identities

remain confidential); Farnsworth v. Proctor & Gamble Co., 101 F.R.D. 355, 356-58 (N.D. Ga.

1984) (granting protective order to keep confidential the names of patients participating in study),

aff'd, 758 F.2d 1545 (11th Cir. 1985); Rogers v. Proctor & Gamble Co., No. 83-0487, 1984 WL

3658 (E.D. Mo. May 4, 1984) (research data has little probative value; premature disclosure

would make completion of study difficult; and data is so "inconclusive, unconfirmed, and

unreliable" that "[t]o allow the jury to hear [the] unfinished work would run the risk of misleading

the jury"). One of the cited cases, Plough, Inc. v. National Academy of Sciences, does

acknowledge a researcher's interest in protecting from discovery "the analyses, opinions and

conclusions drawn ... from [her] data." 530 A.2d 1152, 1156 (D.C. 1987). This case, however,

involved internal deliberations of a scientific research committee conducted under a promise of

confidentiality, not underlying research data, and the court's decision rested on the limited

relevance and necessity of the documents, coupled with the committee's interest in protecting the

confidentiality of these evaluations, not on the researcher's interest in publishing her results. 

Another state court case cited by the agency, In re R.J. Reynolds Tobacco Co., mentions a

researcher's publication interest, as well as an interest in academic freedom, but the court bases its

decision to deny discovery primarily on the excessive burden which discovery would impose on

the researchers. 518 N.Y.S. 2d 729, 732-35 (Sup. Ct. 1987). Moreover, the Second Circuit, in a

ruling ordering release of the same information sought by the plaintiffs in Reynolds, questioned

whether the court in Reynolds did intend to recognize a state researcher's privilege and declined to

establish one itself. See In re American Tobacco Co., 880 F.2d at 1526-29. Because these

decisions turn on interests other than the one asserted by HHS here, we do not find them directly

on point. 

existed, there was no possibility that disclosure would preempt publication, since the data requested

had been published several years prior to the discovery battle at issue. In light of the significant need

demonstrated by the tobacco companies, the privilegeeven if one existedwould be overridden.

Id. at 1530; see also In re Grand Jury Subpoena Dated January 4, 1984, 750 F.2d 223 (2d Cir.

1984) (declining to decide if qualified "scholar's privilege" should be recognized because factual

record insufficiently developed).13

In several other cases, courts have not onlydetermined that anyinterest in protecting research

materialfromdisclosure is outweighed by the opposing side's need for the information, but have gone

farther, eschewing recognition of such an interest altogether. In Wilkinson v. FBI, a California

district court declined to adopt either a "researcher's privilege" or a broader "archival privilege." 111

F.R.D. 432 (C.D. Cal. 1986). While acknowledging that the Seventh Circuit had been more amenable

to this theory in Dow, the court stated that

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the researcher's privilege is by no means universally accepted by other courts. The

other cases that have considered the privilege have uniformly declined to adopt it.

Some have been generally sympathetic to the privilege, yet have nevertheless held that

it could not be applied on the facts of the case. Still others appear to be hostile to the

proposed privilege and have declined to adopt it in the first instance. Therefore, ...

the cases considering a researcher's privilege are not only distinguishable from the

case at hand, but are simply too tenuousto justify a major extension of their rationale

to create a wholly novel archival privilege.

Id. at 442 (citations omitted). Similarly, another district court, while quashing a subpoena issued for

production of a researcher's study protocols and notes on the grounds that the plaintiff failed to

demonstrate the relevance of the material, rejected the researcher's claim of privilege: "experts or

researchers do not have any federal statutory, case law or common law privilege which protects

against their having to involuntarily share their expertise with the parties in the litigation. Nor does

[state] law provide privilege protection for academic orscientific researchers." Anker v. G.D. Searle

&Co., 126 F.R.D. 515, 519 (M.D. N.C. 1989). See also In re Snyder, 115 F.R.D. 211, 213 (D. Ariz.

1987) (quashing subpoena ordering researcher to give deposition testimony and disclose underlying

research data because researcher had already been required to respond to four prior subpoenas in

related litigation seeking similar information, but ruling that "there is no general academic privilege

protecting [the researcher'sinformation]"); Wright v. Jeep Corp., 547 F. Supp. 871, 876 (E.D. Mich.

1982) (reversing magistrate judge's order quashing subpoena of researcher and rejecting researcher's

privilege as unsupported in case law and contrary to general rule of disclosure).

At this juncture in the development of the law, we cannot say that there is an established or

well-settled practice of protecting research data in the realm of civil discovery on the grounds that

disclosure would harm a researcher's publication prospects. This is not to say that there never will

be such a well-established practice; we would not presume to say how many cases are sufficient to

transform an occasional grant into a generally recognized protection. But as of now, however, the

precedent does not rise to the levelof a routinely accepted dispensation shielding data fromdiscovery

in order to preserve a researcher's opportunities for publication. Because therefore the agency has

not defeated Burka's claim that the data he seeks is "routinely available" in civil litigation, it may not

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14Additionally, it is not clear to us that the agency has successfully demonstrated that

disclosure of the results would hamper its researchers' interests. The information sought by Burka

relates only to the baseline data, not to the effectiveness of the smoking cessation intervention

efforts. The agency asserts that it plans to publish additional articles, but has not indicated how

disclosure of the baseline information alonedata already the subject of several articles published

before conclusion of the studywill affect its ability to publish any remaining pieces. 

withhold the information pursuant to Exemption 5.14

* * *

In order to withhold the tapes and questionnaires sought by Burka, the agency bears the

responsibility of demonstrating that this type of information is shielded from discovery for the same

reason that it asks us to protect the information from FOIA disclosure requirementsbecause

disclosure would diminish the researchers' ability to publish their results in prestigious journals. It

has not done so. Since the agency has not satisfied its burden of showing that the questionnaires and

data tapessought byBurka fall within the scope of Exemption 5, we reverse the district court's grant

of summary judgment for HHS and remand for further proceedings consistent with this opinion.

So ordered.

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