*1 problem regulations, cise” summary judg- view of the nature of the identified III, comfortably itself statutory may short of the ment not lend anything Part n.17, 93 at 621 S.Ct. 2479. by Supreme in former. 412 U.S. hearing identified Court here, majority as the alternative to is the situation as the Hynson summary This judgment inadequate accomplish recognize, perhaps will be to and as is most appears to satisfactory problems, resolution of these by years to the three it eloquently testified either in the first instance or summary took for FDA to conclude that by this court further upon review. Wein- judgment justified, lengthy was berger Hynson, Dunning, v. Wescott & judicial period of time consumed in a review 609, 621, 2469, U.S. S.Ct. L.Ed.2d 207 justi- which has had to conclude that FDA’s (1973). doing apparent fication for so is not so as to dispense agency hearing with a further hand, applicant’s On one if the bur- McDonnell, “some kind.” Wolff v. 418 U.S. den on having charged by been remand — 539, 557-58, 2963, 41 94 S.Ct. L.Ed.2d 935 failing FDA with meet agen- one of the (1974); Friendly, and see Kind of “Some cy’s “imprecise” testing requirements —is Hearing,” 123 U.Pa.L.Rev. simply put in the record some factual or logical “support for view” that [its] view, my accordingly, summary judg- met, requirement Maj.Op. is indeed at- where, ment should not be sustained of 190 D.C., U. App. F.2d, S. at 1125of 587 here, charged merely with a applicant it is imagine applicant, hard to that an “imprecise” testing failure to meet an re- whose appear submissions to FDA do not FDA, quirement established but where us stage conclusively at this to be insuffi- its failure to conform the scientific norm face, cient on their could not almost auto- requirement underlying that is not conclu- Hence, matically comply on remand. sively apparent the face applica- result of remand and review in this court circumstances, tion. Under these FDA almost inevitably require would be to required should be to utilize statutory statutory hearing anyway, fur- hearing procedure determining ther delay on the road to the merits. On application sufficient, and, so, if hand, the other if applicant’s burden of whether it approved. should be production stringent is more thus is —and inconsistent with recognizable notion of “summary judgment” is difficult to see —it how the more pro- or less informal remand
ceeding contemplated place will FDA or' us
in a position better now than we are in to resolve questions the “complicated in scien- al., Appellants, H. Peter FORSHAM et tific methodology” to by referred the ma- - jority. Maj.Op. U.S.App. of 190 D.C., 1118 of case, 587 F.2d. In either CALIFANO, con- Joseph Jr., Secretary A. siderations of expedition cannot be over- Department Health, Education looked, especially proceeding in a which has Welfare, et al. has; been going long on as as this one No. 76-1308. indeed, it may well it probable seems be— Appeals, United Court of States that, light problems raised me— the District of Columbia Circuit. majority opinion, abandonment at this point of summary judgment is the shorter— 2, Argued Dec. 1976. rather longer than the to final ter- —route July Decided mination matter. July As Amended The Supreme mightily Court labored Rehearing On Oct. Hynson to include weapon summary judgment in the procedural FDA’s arsenal.
But, doing so, at pains recognize
that there are “imprecise” “pre- as well as *2 Baltimore, Md., Md., was on
of the State brief, Klimt. appellee, BAZELON, LEVENTHAL and Before MacKINNON, Judges. Circuit *3 by Circuit filed for the Court Opinion Judge LEVENTHAL. Judge Circuit filed opinion
Concurring MacKINNON. Judge opinion by Circuit
Dissenting filed BAZELON.
LEVENTHAL, Judge: Circuit appeal presents aspect In its broad under what condi- question whether and private group compiled by tions data grant-in- money under a federal receiving “agency rec- are or become program aid ords” virtue of the fact that program and has the author- has funded the those ity to demand records. brought by specialists
An action was diabetes, as individuals the treatment committee,1 to obtain raw research Pro- University Group Diabetes data of the program privately is a gram (UGDP). The long-term federally funded conducted and diabetes, study of the treatment clinical reported certain harmful conse- that has Freishtat, Boston, Mass., with Harvey W. upon long-term use quences attendant Roccograndi, Chayet & Anthony whom J. hypoglycemic agents. Plaintiffs of oral Boston, Mass., Sonnenreich, was on the validity study, of the and are question brief, appellants. therapeutic concerned lest a useful tool Justice, the market. Kimmel, unnecessarily Michael removed from Atty., Dept, of Lee, C., the raw in order to Washington, They D. with whom Rex E. seek access to Gen., Silbert, challenge study’s Atty. Atty. implement Asst. Earl J. U. their S. Schaitman, Atty., Dept, validity. and Leonard
Justice, C.,D. were on the Washington, Free- brought under the The action was brief, appellees. for Federal (FOIA), 5 Act U.S.C. dom of Information Kurz, to each Atty. Asst. That Act is addressed
Mary Elizabeth Gen. § Md., Baltimore, Md., “agency” with of the Federal Government State of subject Feldman, Gen., Broadly Atty. speaking, Asst. whom David H. defined.2 behalf, physicians any own department, 1. Three sue their title includes executive mili- tary department, corporation, behalf of the Committee on Care Government Diabetic, complaint corporation, as an unin- described in the controlled other Government or corporated physicians in- of 178 association establishment the executive branch of the daily management (including volved in the treatment and Government the Executive Office President), any independent regula- of diabetes. 552(e): tory agency. § 2. 5 U.S.C. purposes section, For of this the term “agency” 551(1) as defined in section of this rep- sons associated with each to make it directs exceptions, Food and information, of NIAMDD. certain resentatives available to the not involved Drug Administration It establishes records.” “agency and also design inception, or enjoin planning, “jurisdiction Court’s the District was funded withholding agency study. rec- from responsibility its part production NIAMDD as and to order ords from the field of diabetes improperly withheld research in support 552(a)(4)(B). regulatory ob- any specific 5 U.S.C. complainant.” § and not tional Institutes grant on under the tive stitute of Center at cation and Welfare. cy” al 1. The UGDP Service, § 241(c). The UGDP grants NIAMDD). participating organization Institute Diseases Public basis of administered The Arthritis, made to the UGDP statutory A. BACKGROUND (hereafter is a Health University grants Department Act, being That institute Study of university medical centers within their Health, Metabolism and The grant-in-aid Service were made to each of and the by applications, funded sometimes the Public Health grants part which in of Maryland.3 Act, 42 Health, Coordinating is an National In- by 13 feder- of the Na- Sponsoring were made authority Institute turn is “agen- Diges- U.S.C. Edu- jective in mind. rare. individual review by this Institute is vision of the of data for review erations NIAMDD. normal charts nating grants outstanding currently Due to the mately 1800—it would 9. The UGDP raw data require grantees sf: responsibility grantee. Management practice Center and are not owned of [*] periodic investigators forms) grant-supported to the Furthermore, large grantee’s (45 CFR of NIH or [*] and, raw data are the institute reports — of the number to submit their raw generally limited [*] not be funded activities grantee. §§ and fact, property of the day-to-day op- (e. submitted this Institute 74.80, 74.82). is of research activities *4 the Coordi- [*] is submission g., extremely physically approxi- patient Super- [*] is background facts are pertinent The subject raw for the Institute to possible presented in of Dr. Donald review, the affidavit G. submitted, data, to critical and' if Whedon, of NIAMDD: Director data of of the raw require submission study have been an would the UGDP the UGDP inspiration
4. The
It
requirement.
private non-government
extraordinary
study came from
re-
applications
practice
evaluate
scientists
mid-1959.
physicians and
progress
grants on the basis
study
newal
Between 1959 and
before
reports submitted
entry
reports
final
began with the
first
actually
was followed with
methods,
practice
design,
objec-
NIH. This
patients,
specific
grants. No
per-
respect to the UGDP
were evaluated
tives of
University
grantees
of Alabama
3. The institutional
are:
Birmingham, Alabama
University
Case-Western Reserve
University of Cincinnati
Cincinnati, Ohio
Cincinnati, Ohio
Baltimore Medical Center
Greater
University Maryland
Towson, Maryland
Baltimore, Maryland
Hospital
of Brook-
Jewish
and Medical Center
University Minnesota
lyn
Minneapolis, Minnesota
Brooklyn, New York
University
Rico
of Puerto
Virginia Mason Research Center
Juan, Puerto Rico
San
Seattle, Washington
University
Washington
of St. Louis
Hospital
Massachusetts General
Louis,
Boston,
St.
Missouri
Massachusetts
University
Virginia
Rush-Presbyterian-St.
Center
West
Luke’s Medical
Morgantown,
Virginia
Chicago,
West
Illinois
quality
in-depth assessment of the
for an
grants required
provisions of the UGDP
a re-
study.
Society
made
Depart-
data to the
the UGDP
submission of raw
Health,
apparently
1974 that
ment
Education and Welfare.
to the Institute in
port
74.23,
on both sides of the con-
Pursuant
to 45 CFR
officers or
some merit
found
§
some of
employees
Department
troversy.
could ob-
It
that while
concluded
purposes
tain access to the raw data for
were val-
the criticisms of
inspection
and copying
unpersuasive,
audit
if access
and the evi-
id most were
pertinent
grant.
deemed
harmfulness adduced
the UGDP
dence of
the subject
data which are
of this
“moderately strong.” This was
study was
by,
case have never been seen
or been in
in the American Medical Asso-
made
of,
possession
employee
officer or
February
ciation Journal for
1975.5
* *
of the National Institutes of Health.
Drug Administration
2. Food
sought by the
documents
particular
on
are observations
case
in this
plaintiffs
Drug Administration of
The Food and
moni-
who were
patients,
over 1000 diabetic
HEW,
of the UGDP
being apprised
re-
estimated
It
years.
to 8
October, 1970,
tored from 5
sults,
Bulletin to
in its
issued
docu-
55 million such
are some
there
community a recommendation
the medical
ments.
should be used
tolbutamide
adult-onset,
cases of
stable diabetes
June, 1970,
investigators
could not be controlled
diet
could
presentation
made a
methods and
June, 1971,
not be
with insulin. A
treated
*5
initial results of their
at the annual
proposed
FDA
changes
labeling
bulletin
meeting of the American Diabetes Associa-
hypoglycemic drugs
of oral
to warn of car-
tion. The results
that the admin-
indicated
diovascular hazards.
Plaintiff committee
(an
hypoglyce-
istration of tolbutamide
oral
enjoin
proposed labeling
sued to
the
on
drug)
mic
to mild adult-onset diabetics led
ground
study,
of
in the
deficiencies
UGDP
to a death rate from cardiovascular disease
and the First Circuit remanded to the FDA
higher
groups
that
treated with diet
than
of
for exhaustion of administrative remedies.6
insulin,
alone,
dosage
with
a fixed
The FDA deferred further action on the
dosage of
The
with a variable
insulin.
find-
the review
the
labeling pending
UGDP
in the
ings
published
were
December
study by
Society.
already
the Biometric
As
Journal of the American Diabetes Associa-
noted,
report
the 1974
of the Biometric So-
During
tion.
1970 and
over a dozen
mixed,
found
ciety was
but overall
“moder-
published
journals
articles were
in medical
strong”
of harmfulness
ately
evidence
concerning
study,
supportive
some
study.
Its
contract
some critical.4
require
Society
NIAMDD did not
data,
The NIAMDD contracted in 1972 with
access to the
but it
seek
UGDP
Society, private
apparently
the Biometric
internation-
examine some of the raw
did
biostatisticians,
professional
require
al
The contract did not
society
data.7
listing
Fed.R'eg.
original patient
study,
4. For a
see 40
records of the
28592.
UGDP
light
and continues:
“While in
of our discus-
5. 131 AMAJ 615.
propriety
sion we need not resolve the
of each
requests,
we
we recent-
these
reiterate what
Bradley Weinberger,
(1st
2. To
HEW records
any possible
avoid
misunderstand-
ing,
ruling
we articulate
our
NIAMDD).
embodies
ing
(of
activities
FTC,
Sterling Drug,
U.S.App.D.C.
plaintiffs
require
Inc. v.
will
issue of fairness to
237, 244,
698, 705;
EPA,
light
450 F.2d
Robles v.
attentive consideration
of the ad
843,
(1973), repeating
quotation
F.2d
of risk of
ministrative record. When issues
Law,
Davis,
Supp.
involved,
may
from K.
Administrative
harm are
use results
(disclosure
“depend upon
§ 3A.22
was never to
of scientific researchers even without access to
party
data,
interest or lack of interest of the
underlying
as is evidenced
the fre
seeking disclosure”).
studies,
quent
foreign
g., Ethyl
use of
see e.
EPA,
373,
Davis,
Corp.
400,
U.S.App.D.C.
See also K.
id. at
“The Act
§ 3A.29:
party
(en banc),
denied,
never takes into account the need of the
F.2d
cert.
426 U.S.
disclosure;
seeking
it never calls for bal-
96 S.Ct.
Plaintiffs’ claim is
effect an assertion
record)18
doing
in the course of
its
government
that
the federal
should be re-
work,
quired formally
constructively
ex-
is there an
record that can be
—
—to
contract-grant
right
ercise its
of access in
demanded under FOIA.19
duty
U.S.App.D.C.
17. 164
1137 cians, impact far-reaching. be would are considerations Overarching policy 5. any one There is a of in physician applicants. The number documents by stressed legisla- of reform reading millions plea stupendous reaching for liberal be would — legislation this reform agree tion. We The number us. of single ease before in con- niggardly be construed should not is not a matter grants contracts federal objective. The legislative of travention Orleans, they record, as noted of but was “a gen- Act embraces thrust” of the “basic in the annually for disbursements account disclosure” agency full philosophy eral of implications of billions. The awesome the ob- exemptions and subject specific to shrugged be cannot plaintiffs’ contention of administrative pierce the veil jective “to permits technology ac- off because modern open agency to action secrecy and through comput- tape cess to on documents scrutiny.”20 light physical pro- without need printouts, er However, avoiding general policy of duction. charter for secrecy give does not on federal engaged research Scientists beyond the law the domain extending docu- grants accept must the fact is the records” that “agency” “agency government, with the federal ments filed data in Act. To stretch for keystone of the own initiative or whether the scientists’ on grantees, cannot possession of federal demand, are lawful sub- an audit or other contemplation the fair justified as within be terms, any in scientific ject to Even FOIA. time the law was either at the Congress for the kind surrogate provides such audit amended, today or even passed or to usually accorded scientific reliability specific to reconstruct trying doctrine replication experiments when by studies light broad legislative intent However, undertaking to be feasible. by Congress.21 purposes disclosed personnel is not the responsible by audited requiring tautology say to It is accept rummaging agreement same as an promote grantee records will disclosure of large. world of FOIA. But disclo policies the disclosure by specula- the statute unless required by sure is not will not trim FOIA court Congress are records. those records or reaction of as adverse motivation tion FOIA, fashioning a balance struck Similarly, the court cannot the scientists.22 pursuit of the boundless precludes which Act of the reach of the supply the extension policy, to policy goal, one even a dominant by building policy on a sought by plaintiffs countervailing all consider the exclusion of an extension would speculation that such ations. and re- cooperation scientific not throttle beyond matters our involves search. This If given the statute is kind notice. sphere judicial interpretation sought by plaintiff physi- proper FPC, U.S.App. government v. 144 Co. involved in Montana Power tum denied, 263, (1970), program, planning cert. 400 739 or execution of the D.C. 445 F.2d core whether, 566, (1971). by contrast, entity 1013, retains its 27 627 U.S. 91 S.Ct. L.Ed.2d during private fide fashion character bona that results in the the course the endeavor Exemption considering 4 for trade secrets however, situation, records. Even in the latter information, court found it or commercial government are examined inquire whether non-commercial irrelevant through rights may rec- audit become mean-spirited “a lot who are either scientists if, example, the records ords under Barbary FOIA — ruthlessly pursue as the self-interest pos- copied its or come into field,” pirates or are in their own chosen did session. governed consideration that “se- loftier philosophical crecy values is antithetical Rose, Department v. 425 U.S. of Air Force Proj., Washington Inc. Research science.” 352, 1115, (1976). 360, L.Ed.2d 392 S.Ct. 169, 175, HEW, U.S.App.D.C. 504 F.2d v. Opinions in court the same effect of this 238, (1974). FTC, U.S.App. Myers clude Bristol Co. v. 25, (1970); 424 F.2d Getman D.C. 209, 211, NLRB, U.S.App.D.C. 450 F.2d *10 employees and directly, through its own action, in this in our requested isWhat time, long program so in resources, study the claim view, of statute on a is an extension appraised by covering many that must so be and public space, of interest so broad in give subject the which in legislature the can Even a case controls. patients and opinions elicit from all in- study, extended study a grant where is to conduct the sources, and pro’s and consider the terested by conducted federal might conceivably be con’s. advantage employees, is an in terms there government of advancement effective fitting by referring to close It is study by is public the if the done of interest need, any pondering of such exten- the goes government various The FOIA, institutions. for considering sion the the im- employ- of its own beyond capabilities pact philosophy purpose on the of Fed- ees, insights spirit grant programs. adding eral have who selected a and students scientists represent a means for programs Grant learning. at a center of style, different life society our which is root- governance conception the value of pluralistic ed noted, not concerned As we are earlier private governmental drawing on both where of case the feder- here kind with the Federal leading A student of sources. exercises detailed control government al grant it23 puts law presents a condition operations. over Such is assistance to an autono- grant The considerations, as noted in Orle- different grantee. grantee The is not an mous suggestion have a of sub- ans. Nor do we arm, agent instrumentality terfuge, agency seeking to with a federal employees grantor. grantee scrutiny conduct research outside employees. are not federal The torts of laws, using government by facilities that are not grantee federal torts. The only nominally. are independent The case property grantee is not federal before us concerns UGDP conceived property. private, non-government physi- in 1959 by grantee” reference to “an autonomous They developed cians and scientists. their concept, not an observa- a core incidental methodology; own it was not dictated grant program tion. In a the federal government. federal government gets advantage of services course, funded any program Of doing someone who is his own rendered government opportunity federal there is thing. own autonomous It is not thing, his for the to assess results of government government operation the same as a in dis- performance studies. There guise. by the federal may also be directions Through grants university groups, its government matters of in certain government obtains efforts of cre- essentially peripheral to the policy that are who flourish in an academic persons ative may, There core of work done. arrangements atmosphere. provide Such example, requirement of avoidance of be a independence measure of detachment and race, grounds religion, discrimination on government agency. from the mission of the may creed or sex. There achievement of may the tug govern- The researchers feel government objectives apply other which strings, an- purse they ment but also feel across the board to all activities financed to the standards of their academic swerable government. federal colleagues. question central Plaintiffs cite the multi-million dollar na- government really involved the core of ture of the as a for access. reason question program. least a whether the At least in a case such as the There is at no us, could claim government federal have conducted one where there before Mason, 23. M. S. Current Trends Grant Law-Fiscal Year 35 Fed.Bar. Federal 167-68 complaint. In such case from the of day-by- control significant government *11 may contents . . . examine court involvement in operation, or detailed day . .” records in camera . agency such of program, planning or execution from added.) A fair conclusion (Emphasis autonomy of concept grantees of the overall just it is that not foregoing indicates though there are federal ob- persists, even “agency records” that but “records” jectives, right perhaps and of federal audit addressing. is statute requirements. overarching federal some opinion page-of court’s at The fleeting reference should be At least a page 1136 of 587 F.2d U.S.App.D.C., some of acknowledge to the fed- made states: of the state grantees are institutions eral only if principle is that governing The There thus are considera- governments.24 (or a has obtained record agency a federal These are not of federalism involved. tions record) in the has a to obtain the duty dimension. necessarily of constitutional work, agen- is there its doing of course However, are not without relevance they can be demanded record that cy extent to which such appraising the [Emphasis FOIA. added.] automatically governed by grantees are necessary is not to statement The italicized by Congress for the federal provided rules join I Each and do not it. our decision govern access to records agencies, such as rec- involving request a for particular case personnel management,25 or meetings, and agency but possession not in the of an ords or other rules. which, duty is some alleged, there it is indicate a foregoing The matters on its to obtain the records must decided struck, one considers balance must be I would leave to circumstances. particular that are autono- advantages grantees opinion any to the future declaration as a they and value because are not mous have inter- the FOIA should be extent which conflicting governmental, possibly by, not created preted to cover records policy that cherishes full and free possession by, otherwise in the obtained or government agencies shuns access implication de- plain The agency. of an balancing a secrecy as Such invidious. of the statute is language from rived legislature. task for extension belong which apply that it does to records ground sought by plaintiffs access on possession in its agency or are —that properly not addressed to public interest is is, agency created records which courts. is all that needed That obtained. rec- I not refer to this case. would decide Affirmed. be said that an might ords about which duty obtain might have some MacKINNON, Judge, concurring: Circuit presented we until such time as are join Judge generally I Leventhal’s question directly that raises case opinion following but wish to add the obser- neces- to us all the relevant facts presents vations. applicability the FOIA sary to decide the 552(a)(3) “[Ejach provides: 5 U.S.C. § to that situation. . agency, upon any request for records . go would even further The dissent promptly shall make the records available interpretation of for the normal substitute 552(a)(4)(B) any person.” also U.S.C. § meaning to be language of the statute ” “agency refers to the location of records from an extraneous examination derived constituting conferring one basis for as surrounding “all the relevant circumstances “jurisdic- district the district court creation, use preservation, [the] enjoin withholding from (Dissent tion to at-of records” particular F.2d, production empha- and to order agency records 1142 of 587 U.S.App.D.C., at Then, re- analysis this original). improperly withheld sis any agency “[i]f Usery, University Mary- League U.S. supra, National Cities 24. See note 96 S.Ct. L.Ed.2d land. Program Diabetes Group University in- degree of federal significant veals a records, they then are locked in a (UGDP). volvement with the The UGDP sub- custody should be considered ‘records’ Maryland bank vault in omitted). ject (Id., footnote to FOIA” For the coordinator. program interpretation allowing catch is they majority, means a judge might what upon statute to turn under the subject to disclosure “records” degree “significant of federal consider a (FOIA). Act With Information Freedom of attempt impose involvement.” The is to agree. respect, due I cannot all standard varies foot” which “chancellor’s possession than view, other my factors however, statute, judge. with each *12 determining whether the are relevant in construction, and susceptible not of such agency data are “records.” so, them gives for those whose foot happily provided Federal has all of the Government find to be a would records short standard UGDP; funding the Government for the wherever there was “agency records” right has an of access to the unrestricted access to records. funding federal or data; courts, importantly, and Government standard, applied That as some practically the FOIA to un- on the UGDP and extensively would extend relied in those and lengths limited universities affecting in action regulatory engage private in industries which research. I think these fac- treatment of diabetes. If Act to Congress desires the be so extend- cumulatively significant establish a de- tors ed, by enacting appropriate can do so it with gree involvement federal legislation; my but view coincides with that I would Accordingly, hold that data. expressed Judge opinion, in Leventhal’s they are “records.” agency that extreme extension of the Act such an by judicial should not be created fiat. I. conclusion, reaching In this I see no harm requires Information Act The Freedom of particular to records are public. Where “records,” all inquiry, agencies as in the federal to disclose subject legitimate dissent, they two to in the 552(a)(3),1 cases referred that do fall within U.S.C. § may subpoenaed by parties. be interested 552(b)(l)-(9). Id. exemptions. one of nine § No the term “records” is found definition of
BAZELON, Judge, dissenting: Circuit legislative history.2 in either the Act or the law, focusing exclusively The case almost Plaintiffs seek disclosure the raw data light little federally-sponsored exemptions, of a on the sheds on this project, research request (1974), Cong. agency, upon Admin.News for records U.S.Code & [E]ach pp. (A) reasonably which describes such records (B) published in and is made accordance with Attorney 2. The 1967 General’s Memorandum time, place, stating (if any), rules fees and does one sentence relevant to the defi- contain followed, procedures to be make the shall says: nition of records. It “Subsection promptly any person. records available to refers, course, (c) [552(a)(3)] only to (1974). 552(a)(3) originally en- U.S.C. As § being possession control of an or acted, provided: Clark, this section agency.” Attorney Memo- R. General’s request agency, on for identifiable [E]ach randum Information Section Public published (1967) in accordance records made with Act re- the Administrative Procedure time, stating place, printed the ex- rules fees to in Freedom of Information Act Source statute, Book, procedure Cong., S.Rep.No.82, 2d tent authorized 93d Sess. added). Although followed, (1974) (emphasis promptly the Attor- shall make the records ney guide any person. a General’s Memorandum is doubtful available to intent, Davis, congressional see K. Adminis- was amended in 1974 to make clear The section (1970 Supp.), trative fact ‘description’ requested Law Treatise of a that document “[a] defining agency refers to two criteria professional if it enabled would be sufficient a possession suggests or employee who familiar with was “records” — control — approach adopted more inclusive than request subject area of the to locate the argue majority. I would also the At- record with a reasonable amount of effort.” torney Memorandum is consistent General’s Cong., H.R.Rep.No.876, 5-6 93d 2d Sess. it, put the fundamen- Report As the Senate We thus left with little direct term.3 public as is that “the guidance to elucidate a of the Act attempting key premise tal provision of Act. know what its right a whole has S.Rep.No.813, 89th doing.” Government not discuss difficul- majority does de- 1st Cong., Sess. defining agency “records.” involved in ties Report, “to signed, in the words of asserts, supporting with little It ra- simply of full general policy establish a tionale, question the crucial exempted unless information disclosure have been “created” the documents statutory lan- clearly delineated adopt- agency.4 federal “obtained” ” House, . . Id. at 3. In the joins guage. approach, majority ing Congressman after rose Congressman the federal defendants district as looking property speak policy underlying court to such factors in support of the possession defining rights it, was, variously put they the bill. This I objection “records.”5 have no title or re- “to information right object, custody I do as relevant criteria. policies actions Federal lating to the however, test based on some of (re- (1966) Cong.Rec. 13655 agencies,” 112 factors, many possibly relevant with little *13 Hall); the facts “to know Rep. marks of justification primacy of offered government,” of their operation about place to start in deter- these factors. The Reid); Rep. of “to be (remarks id. at 13657 mining the of “records” is not scope agency policies and activi- informed about fully assertion, an of with but with examination Government,” at id. of the Federal ties policies of FOIA. Faschell). (remarks Rep. of These 13648 suggest the need for broad There can no about the basic statements doubt goals agency of Act. definition of “records”: broad of Freedom Information here, my concurring op. reach the result I would since in of 587 F.2d. But see at-of U.S.App.D.C., involvement with
view the Government 190 at 1139of 587 F.2d. “control.” UGDP data amounts to 5. The district court found that CIA, v. No. 76- & Skidmore 3. But see Goland Department (1) employee no official or of the (D.C.Cir., May 23, 1978) (congressional 1800 Health, (HEW),the Education and Welfare agency not hearing transcript possession of in (NIH), Institute of Health the Food National Corp. record); Development agency SDC an (FDA), Drug or the Na- Administration 1976) Mathews, (9th Cir. F.2d 1116 542 Arthritis, tional Institute of Metabolism library (materials in reference not medical Digestive (NIAMDD) is now or Diseases records); Willingham, agency 400 F.2d Cook v. possession in issue ever in of raw data been 1968) curiam) (presentence (10th (per 885 Cir. Group University relating to Diabetes authority report prison not an in hands .; Program (UGDP) (2) . . the raw data Mathews, record); agency Ciba-Geigy Corp. v. question property of the indi- [sic] (UGDP (S.D.N.Y.1977) F.Supp. raw 428 523 coordinating investigators vidual records); agency United Nichols v. data not possession, remains custo- center and aff’d, States, (D.Kan.1971), F.Supp. 460 325 130 dy and control of the UGDP coordinat- 966, denied, (10th Cir.), 409 U.S. F.2d 671 93 S.Ct. cert. .; (3) ing . center neither individu- 268, (1972) (physical L.Ed.2d 232 34 investigators nor coordi- al relating to assassination President evidence ‘agency’ purview the nator within the is an “records”). Kennedy I exclude cases not Act, 552; Freedom of Information 5 U.S.C. § “agency.” E. a federal turn on the definition of g., (4) consequently, data in issue David, U.S.App.D.C. 448 Soucie v. 145 ‘agency subject not records’ disclo- (1971). F.2d 1067 provisions sure Freedom Informa- Act, 552(B) [552(a)(4)(B)], § tion 5 U.S.C. U.S.App.D.C., Maj. op. at at-of 1136 (J.A.) (footnote Appendix at 146-47 omit- Joint ted). majority Apparently, of 587 would F.2d. recognize agency also “records” where the in position is “the planning The federal defendants’ “core Government is involved ‘agency maj. op. of Infor- program, term records’ the Freedom or execution” of at- 19,---of applies posses- U.S.App.D.C., Act to ‘records’ in the mation n. at 1136 agen- n.19, F.2d; or owned sion of federal 1138-1139 where a day-to-day supervi- cy, produced duty under the or has a obtain federal Maj. records. agency.” Br. at 17. op. sion of an Gov. U.S.App.D.C., at-of at 1136 exemptions 552(b)].” S.Rep.No. enough public everything to let the know of the [§ (emphasis part). doing;” supra “its Government is to illuminate all added “policies and activities of the Federal purpose Both the and the structure Government.” point broadly to a inclusive definition “records”—a definition encom-
The principle require that “the disclosure passing “all materials Government.” .,” ment be broadly construed . Sou seriously I law notions doubt common David, (D.C.Cir. cie v. 448 F.2d custody can define the property totali- 1971), is also the structure of rooted in view, ty my appro- of such records. In enacted, FOIA. Before the pub FOIA was priate the statute is to ex- approach under lic information section of the Administra sur- amine all the relevant circumstances agencies tive Procedure Act allowed creation, and use rounding preservation, “in the withhold information inter analysis re- particular If this records. est,” shown,” or if good or “for cause degree of federal in- significant veals a information person seeking the was not records,9 they then volvement with the directly concerned.” “properly and 5 U.S.C. agency “records” sub- should be considered exemptions These broad cre § ject to FOIA. “withholding ated what was in effect a statute,” not a “disclosure statute..”6 To II. situation, remedy Congress enacted a emphasize statute Plaintiffs three forms of containing general disclosure sec fed- narrowly tion and nine drawn eral involvement with the UGDP research exemptions. data, funding data: federal provided The disclosure section federal “any data, person” access to the and federal reliance on could have access to “record,” decisionmaking. the data in administrative having without to state a reason We need decide whether one of these for wanting the information. And the ex *14 factors, or even two of these factors in emptions provide were drafted to “defini combination, would be sufficient to make guidelines”7 tive as to what information the agency UGDP data “records.” Where could be To loopholes, withheld. avoid new however, present, all three factors are I Congress expressly grounds limited the for clearly agency think these materials are specified nondisclosure to'those in the exe “records.” mptions.8 objective was to “make it beyond clear of doubt that all materials Funding A. Government Government are to be made available to the public publication by or otherwise unless percent One hundred of the UGDP fund- explicitly kept by ing provided by allowed to be secret one the National Institute S.Rep.No.813, supra 1138 of through 587 F.2d is at 5. to be realized restrictive definition of “records.” Id. at 3. grappled 9. Another court that has with whether raw data UGDP “records” con- This section does not authorize withhold- goals purposes ing availability cluded “that and of of the Act information or limit the of public, imposing except specifically would records to the be served best a standard proof stated in this section. which calls for that the records were subject 552(c) either Government-owned or to sub- 5 § U.S.C. agree stantial Congress Government control or use. In other enacting I words, appear signifi- policy must struck it a deliberate there was balance between of countervailing poli- full cant Government disclosure and various involvement with the records Maj. op. U.S.App.D.C., cies. at-of 190 at themselves in order to deem them rec- Mathews, legislative history Ciba-Geigy 1137 Corp. of 587 F.2d. But the ords.” abundantly F.Supp. (S.D.N.Y.1977). Although makes it clear that all of the com- I peting policies Congress recognize disagree Judge Tenney’s application saw fit to through specif- standard, were to be accommodated nine particularly his conclusion exemptions. surprise, ic It as a there- directly comes relied on the Government not fore, policy to learn that a not mentioned data, quarrel raw id. at no UGDP I have Congress preserving grantee “autono- —that with his statement standard itself. my,” maj. op. U.S.App.D.C., at-of at 52,22. request. Id. upon § to HEW able Arthritis, Metabolism, Digestive and Dis- publication grantee copyrights if the And (NIAMDD), of the institutes of eases one regulations grant, resulting from of Health. Federal the National Institutes free, nonex- royalty give the Government funding significant purposes for FOIA is translate, pub- reproduce, license “to clusive First, funding of scientific two reasons. disseminate, dispose of use, such lish, activity, and FOIA was is a federal research do others to so.” authorize materials to obtain infor- enacted to allow provisions proba- these 52.23. Id. While § activities—includ- all federal mation about establishing full federal fall short of bly Con- money. As one ing expenditure data, Br. see Gov. UGDP ownership of the it, part gressman FOIA was intended put establish, think, I that the 26-31, they do rights responsibilities enhance degree of a substantial Government has by making possible voting public disposition use and control over know “what their Government them to UGDP records. Cong.Rec. doing money.” with their (1966)(remarks Gurney); ac- Rep. Access B. Government (1964) (remarks of Cong.Rec. 17088 cord 110 regulations, grant the HEW Dirksen). Under Sen. apparently unlimited Government has funding of the UGDP also Federal raw UGDP data. access to the right of funding brings with it important because 74.23(a)provides: F.R.C. § control over the significant Government Comptroller General HEW and the maintenance, use, disposition of the States, any duly of their autho- United can This ex- data. seen shall have representatives, access rized governing the amining regulations HEW books, documents, and rec- papers, any relationship between Government any of grantee which them ords of the regula- these grant Under recipient. specific pertinent to a determine are obliged “fi- tions, to retain grantee making grant, purpose for the HEW documents, sta- records, supporting nancial examination, excerpts and tran- audit, perti- records, other records and all tistical scripts.10 grant” period for a to an HEW nent and “ex- to “examine” permitted HEW is receiving years grant. three after records the financial cerpt” If granting 74.20. C.F.R. § UGDP, records. This raw research but also generat- determines *15 fact that when the is demonstrated grantee “long reten- ed have term audit of a scientific FDA conducted value,” the rec- agency may tion order UGDP, raw data were ex- portions of the per- to ords transferred the Government investigators, cop- by government amined 74.20(b). At custody. manent Id. all § agency. ied, by the Gov. then and retained times, right Government has the of Memo, Dec. Supp. of books, documents, papers, access “any to grantee” purpose to right and of the for the of access records The Government’s examination, “audit, important for FOIA making excerpts UGDP data 74.23(a). basis regu- Id. it establishes transcripts.” purposes and since § with FOIA re- compliance grantee that the re- require lations further Government must Obviously, the Government notes, quests. techni- “[ljaboratory tain all related requested copies of able to pertain to be obtain cal and information” impedi- legal without invention, quickly avail- “records” patentable and make them years may after administration two to the ords for 10. The have access Government discontinued, and assert regulations as well. an IND FDA been UGDP raw data under its INDs 312.1(a)(12)(6)(e)gives use of more FDAthe the UGDP discontinued § C.F.R. ago. relating years Br. at 34-35. How- right investigator’s Gov. than two ever, access to records (INDs). the UGDP has drugs is no indication that investigational there to new records, the FDA or that J.A. at fact discarded two INDs from the FDA. UGDP holds years extinguished right two after regu- access federal defendants note that stops. anof IND requires investigators administration such rec- lation retain history of federal in the extensive found example, For if the ment.11 Government data, purchase subpoena certain or had and data on the UGDP reliance with a re- comply certain dealing with the treat- action regulatory might not be con- quest, these materials This reliance must of diabetes. ment “records.” We need not de- sidered background of intense against the viewed question, for no such barrier is cide this surrounding the UGDP ever controversy involved here. The Government can exer- pub- were study’s since the first conclusions right cise its of access to UGDP data lished in 1970.13 sure, any any time and for reason. To be findings, initial greater may inconvenience be involved in Release of UGDP’s obtaining copies of documents not correlation between suggesting possible But, custody agency. immediate of the drugs and cardiovascular hypoglycemic oral concedes, agency “records” Government impact.14 Profes- mortality, profound had a physical need not be located within the con- convened, sional were articles conferences agency. fines of the Br. at 20 n. 32. Gov. studies published, were scientific were may privately-owned Records be bailed to a evaluating hope undertaken with the warehouse, private entity, loaned to a or determining their UGDP conclusions and may have been sold donated and scientific com- validity. The medical Government but not delivered. In terms of along pro- divided eventually munities FOIA, ease compliance types these Supporters lines. of the anti-UGDP UGDP indistinguishable of situations are from the cost, duration, pa- study’s broad cited the present case.12 base, sophisticated design as con- tient C. Government Reliance validity findings.15 firming the Crit- UGDP, hand, pointed on the other ics of
Probably
strongest
link between the
study design,
alleged inadequacies
the Federal
UGDP data and
Government is
Complications
requires
agencies
lar
Diabetes,
in Patients with Adult-Onset
11. The Act
to determine
comply
request
(Supp. 2)
with a FOIA
“with-
19 Diabetes
days (excepting Saturdays, Sundays,
in ten
Subsequent
reports
published
were
in Knatter-
legal public holidays)
receipt
after the
ud, Meinert, Klimt,
Martin,
Effects
Osborne &
request
such
.
.
.
U.S.C.
Hypoglycemic Agents
Compli-
on Vascular
552(a)(6)(A) (1974).
days
An
§
additional 10
Diabetes;
cations
Patients with Adult-Onset
circumstances,”
permitted in “unusual
includ-
Preliminary Report
IV. A
sults,
on
Re-
Phenformin
ing “(i) the need to search for and collect the
Goldner,
(1971);
217 JAMA 777
Knatter-
requested records from field facilities or other
Prout,
Hypoglycemic Agents
ud &
Effects of
separate
establishments that are
from the of-
Complications
Vascular
in Patients with Adult-
processing
request;
fice
Id.
Implications
Onset Diabetes:
III.
Clinical
552(a)(6)(B)(i)
added).
(emphasis
§
The last
Results,
(1971);
218 JAMA
Knat-
provision appears
specifically contemplate
Klimt, Osborne,
terud,
Meinert, Martin & Haw-
“records” can be found outside
Study
kins,
Hypoglycemic
A
Effects
custody
agency.
Agents
Complications
on Vascular
in Patients
Sears,
with Adult-Onset Diabetes: V. Evaluation of
majority’s
assertion that NLRB v.
12. The
Co.,
Therapy,
132, 161-62,
1)
(Supp.
Roebuck &
Phenformin
Diabetes
U.S.
95 S.Ct.
Renegotiation
*16
(1975)
(1975).
from in suggesting pos- a thorough director and program on a review primarily is based to reach study. of the data base manipulation sible UGDP and of the evaluation drugs to one of the results unfavorable his view reaffirms The Commissioner study.17 study adequate is and an that uncertainty trial, about va- Despite all which is the clinical well-controlled study, inability and the lidity of the UGDP detailed examination most extensive physicians to ex- skeptical scientists and hypo- long-term administration data, Govern- amine Federal the raw yet undertaken. glycemic agents on the find- twice relied ment has believes The Commissioner affecting large a in action ings regulatory a validly conduct- that the UGDP Com- public. segment of opinion accepts ed trial and Adminis- Drug the Food and missioner of and other Society committee Biometric labeling new re- (FDA) proposed tration experts that the increased cardiovascular hypoglycemic drugs quirements for oral this mortality found in trial cannot rea- 40 Fed. treatment of diabetes. used sonably be attributed scientific short- Register (1975). The Federal Reg. 28587 comings study. in the proposed warning stated notice of the part: Id. at 28591.18 A clearer affirmation is hard on the UGDP of the Commissioner reliance judgment labeling imagine.
changes be must made drug See, Feinstein, hypoglycemic g., is an oral Biostatistics: [Tolbutamide e. Clinical University Analytical competitor phenformin.] Appraisal It not An did and a Study, (UGDP) Group Program Diabetes question me state of affairs occur to (1971). Pharmacology, Therapeutics 167 Clin. allegation was made until 1968 when the first Schor, University Group Pro- Diabetes higher death rate was tolbu- that the Mortality gram: Looks A Statistician at meeting group. another tamide At the same Results, 217 JAMA 1671 biostatistician, investigator revealed Klimt, paid U.S. was consultant Dr. FDA Dr. testified as follows before at Bowen Vitamin, phenformin. the then makers labeling public hearings proposed on the denied, acknowledged. at then This was first change hypoglycemic drugs: oral during spirited which A discussion followed aspect has An more not even troublesome potential such circum- for abuse under explored. involves the been well This length. This ended was at stances discussed personal integrity scientific matter of delega- York from New with the demand key group. honesty one member of the independent of the data review tion that actively question This both was considered Dr. outside statisticians. undertaken investigators privately openly among resign was if this done. threatened to Klimt early as publicly as 1968. It also been asked disap- did not meet with universal This threat question since that time. The finally compromise proval, was reached but hopefully must now ask and answer FDA done but Dr. gathered would be in which review the data that were “were honestly permitted accurately choose the re- field recorded and Klimt would be reported coordinating his from the center Bal- Drs. and Brown were Cornfield viewers! fully recognize they my understanding I is a timore?” that this seri- It choices. allegation there is basis for reasona- ous but simply the numbers and methods reviewed You will recall that this was a ble doubt. coordinating center and to them sent study. Investigators did not double blind This even then. that raw data were used patient taking. know what medication proportions episode major a rift of caused simply along to Data and sent were recorded investigators. among the coordinating center. the biostatistician at J.A. 130-31. *17 printout of the cumula- We then received recognized that of FDA 18. The Commissioner told that a if one was tive results. Therefore given study results of the UGDP time the the “[f]rom in a side effect occurred death other subjected reported, study to was the first were patient was on faith it taken tolbutamide and statisti- clinicians criticism both intense investigator for never knew sure. the because the UGDP Society given The was access to Later, 1977, Secretary Califano hypo- After conduct- phenformin, purpose. HEW declared oral this raw data for pub- report an “imminent hazard to glycemic drug, audit, published a ing partial 505(e) of and lic health” under the Food § findings.20 for the indicating support UGDP Act, 355(e), Drug suspended and U.S.C. § later, prior suspension the years Several applications approval drug new for all phenformin, drug applications of new he drug. Secretary this indicated that The its audit of the the own FDA conducted the relying was to a considerable extent on sketchy, are Details of audit UGDP. gathered by the UGDP. statistical evidence the admit that but defendants the federal FDA, The order that which stated “[t]he sample copied at least FDA examined and experienced interpreting analyzing and of its course data the the UGDP reactions, figures has incidence for adverse Gov.Supp.Mem. study. examination of the con- examined statistics and [the UGDP] 5, of Dec. 1977 at 2. figures are scien- cluded the incidence Government-sponsored or conduct- These Secretary tifically valid.” Order importance. ed are of considerable audits 25,1977).19 Suspending Approval (July at 11 at first By examining the UGDP raw data proposed labeling Significantly, hand, satis- apparently the Government has change suspension phenformin were sound. fied itself that the UGDP results are not solely undertaken on basis of words, In relied other the Government has published studies of the In addi- UGDP. directly on raw data in UGDP tion, the ex- Federal Government has twice formulating course of official Government its to the raw right ercised of access UGDP such, policy. precisely these As validity data to verify the the UGDP intended to Congress sort of documents findings. controversy initial When the over Develop- FOIA. SDC be disclosed the UGDP NIAMDD retained an erupted, Mathews, ment Corp. supra biostatisticians, 1119- independent n. group 20.21 Biometric to review Society, the UGDP. maturity-onset patients, compared diabetic Fed.Reg. cians.” 28588. He conceded wide-spread among plus developed insulin. “a with diet diet belief had treatment alone or many physicians study past was reached UGDP has been This conclusion design investigators, somehow its independently flawed in terms of the UGDP execution, FDA, Society therefore could not serve as a and the commit- the tee, Biometrics proper warning pro- basis to the for a medical again and is affirmed the Commis- fession.” Id. hy- oral sioner. Other clinical trials of these poglycemic drugs comparable are not postpone decided therefore study provide implementation warning insufficient evi- UGDP until [review negate findings study by dence to study. UGDP committee of Society] published. Biometrics Since study pro- the UGDP was the basis Id. at 28591. posed warning, the Commissioner believed passage quoted from refers to statistics 19. independent that this validity review of the statistical sources,” “all but it is available Order at study should be to all available clear includ- from the context that the UGDP persons taking interested before definitive 8, 38, pp. ed. The UGDP also to at referred action. The review the committee of 40-41, 46, 63 and 66. Society required Biometrics lysis extensive reana- and was the data the UGDP of Biometric for the Assessment Committee published February until Hypoglycemic Aspects of Controlled Trials of Id. at 28589. Agents, As- Report for the Committee Society audit Biometrics reconfirmed Agents, Hypoglycemic JAMA sessment of regula- in the need for Commissioner’s belief
tory action based on the UGDP. Although shortcomings, [UGDP] emphasizing reliance might the Government’s expected in which clinical trial data, imply I do not complexity, shortcomings of this do not give plaintiffs’ weight finding ap- that the court should invalidate the central there data, plaintiffs’ pears or to “need” for the UGDP be an increased risk of cardiovascu- suspen- position litigants phenformin mortality lar associated with the administra- Maj. phenformin proceedings. Op. tion of and of sion at---of tolbutamide
1147
request
be no
FOIA
would
infrequent
an
III.
currently created
those
than
greater
asserts that
majority cryptically
including
grant,
attached
conditions
agen-
finding
UGDP
data
that the
inspection.24
of Government
possibility
the
with
“au-
would interfere
cy “records”
to have had
appear
these burdens
Yet
recipients. The
grant
tonomy” of federal
enthusiasm for
effect on the
imperceptible
I do not
this is unclear.
meaning of
exact
grants.
federal research
maintain,
argue,22
plaintiffs
nor
do
Consequent-
“agency.”
is a federal
UGDP
chilling
notion could
effect
Secondly, the
that all of
been made
suggestion
no
has
ly,
unscrupulous scien-
danger
refer to
responsibilities
the various duties
valua-
appropriate
FOIA to
would use
tists
imposed on the
should be
federal
their own credit—or
for
research data
ble
before us is
only question
UGDP.
concern,
if
legitimate
This is a
profit.
the UGDP raw data are
subject to
records were
research
grantee
all
of HEW. An affirmative answer
“records”
conceivably
scien-
deter some
it could
FOIA
question
require
this
would
HEW—not
to
grants. But the
seeking
tists
federal
from
copies of
rec-
obtain
these
the UGDP—to
is minimal
danger
misappropriation
request.
plaintiffs’
to
FOIA
response
ords in
here,
relied
where,
the Government
No
manner
direct interference
of its
the course
on scientific records
grantee conducts its
method in which a
reliance will
decisionmaking. Government
would result.
research
to cases where
results
likely
limited
be
to “au-
majority’s reference
Perhaps the
published
previously
have been
suggest
that scientific
tonomy” means
Thus,
weight this
whatever
or announced.
knowledge
would be chilled
activity
contexts,
is
is entitled to
other
concern
grant
a federal
produced
that data
the element of
significance where
of little
circumstances,
could,
in limited
become
present.
is
reliance
advanced
agency “records.” This has been
might be
grant applicants
Finally, federal
finding
for not
policy
elsewhere as a
reason
having methodological or inves-
inhibited
“records.”23
work uncovered
examination, however,
tigatory flaws
their
I think
On closer
request.
little
If this is the
through
even this concern carries
force.
a FOIA
seeks to avoid under
danger
majority
chilling effect could
The notion that a
“autono-
guise
grantee
protecting
subjecting
from
the records of feder-
result
for both the
day
my,” then it is a sad
grantees
to one
al
to disclosure could refer
the Freedom of
community and
scientific
First, it
refer
things.
of three
could
of the scien-
The essence
Information Act.
inhibiting
visit
possibly
effect
thought,
the com-
community, I had
tific
executing a
laboratory by a federal official
scientific
to the advancement
mitment
restricting
request. As
a basis
findings
conclusions
by subjecting
truth
FOIA,
implausible
I
ex-
find
of fellow ex-
“exacting scrutiny
The inconveniences occasioned
treme.
challenge
district
U.S.App.D.C..,
do not
22. Plaintiffs
F.2d. See
at 1134 of
supra,
Sears,
Co.,
ruling,
that the UGDP
see n.
court’s
v.
Roebuck &
U.S.
NLRB
“agency.”
Br. at 28 n. 7.
Pet.
not a federal
n.
perts.”25 p.- at methodology,” Maj. op. see own agency bear earmarks of “records” sub- 1138 of 587 p. at U.S.App.D.C., of 190 FOIA, be the ject height it would F.2d, initiated study was in fact deny ground on the irony to disclosure NIH, develop- responsible was for which expose thereby it could errors or frauds and ing protocol. Petition for the research discourage who do the those work of Moreover, Rehearing at 4. as a condition part Government. was enacted in es- grant, of the UGDP NIH renewal practice withholding end the information Board, which, Policy Advisory tablished “only to up embarrassing cover mistakes ” in initiatives according plaintiffs, “took irregularities. . S.Rep.No. . study,” directing the course the [UGDP] supra, at 3. To restrict definition of government involve- evidence of further accomplish “records” to the same Id. on-going ment UGDP research. in as a regarded giant leap end could at 3-4. backwards. “where opinion notes that majority
I respectfully dissent. entity, we by private records are created will turn applicability believe the of FOIA Rehearing On for Petition government on is involved whether the ORDER pro- planning or execution of core - PER CURIAM. gram.” Majority op. p. at of 190 U.S.App.D.C., pp. at 1136-1137of 587 F.2d. Upon appellants’ petition consideration of that, strong from the Plaintiffs make a case rehearing, for it is inception study, government in- Court, ORDERED, by the that the afore- planning volvement in and execution petition rehearing said for denied. pervasive. been Thus, in addition to the reasons set forth Judge grant Circuit BAZELON voted to my dissenting opinion, conten- plaintiffs’ rehearing for set the reasons forth in the tions furnish basis might well an additional attached statement. “agency for rec- finding these to be BAZELON, Judge, Statement of Circuit Plaintiffs, have previously ords.” could not why as to he rehearing: voted for showing required precisely what known petition rehearing, novel for de- physi- majority’s their under criteria cians who requested point termining UGDP data whether data were degree They signifi- out the unusual of federal involve- have records.1 now raised which, ment in the cant ma- question initiation and conduct of the factual under the which, study, ap- jority’s even under the warrants a remand to de- approach, taken proach majority, bring degree would of NIH involvement termine the these data scope “agency within the rec- initiation and conduct of the UGDP study, ords.” an Specifically, plaintiffs suggest that rather than affirmance of independently court, exclusively rather than had an conceived district which focused Merton, court, considering Sociology 1977) R. an- 275 where the district Science (1973); Barber, request see also B. and the Science noted other FOIA the UGDP data (1952). Social Order 89 “[tjhere authority is little official to aid discerning documents are Court whether According majority, government in- noteworthy at records.” Id. It is program, Maj. volvement the “core” of see authority “lighted” principal that the which op. 19,---of U.S.App. at -n. case, majority’s path was not a FOIA but even D.C., n.19, F.2d, at 1138-1139 of Act. Federal Tort Claims action key determining created Maj. op. p.-of U.S.App.D.C., See at by private groups “agency individuals or F.2d, p. discussing v. United States 1135 of 587 records”, appears which to be the use of first Orleans, 48 L.Ed.2d 425 U.S. S.Ct. concept in connection with the definition Ciba-Geigy records under FOIA. Cf. Mathews, Corp. F.Supp. (S.D.N.Y.
H49 possession ownership of physical records.2 *20 AND EXCHANGE
SECURITIES
COMMISSION INC., INDUSTRIES, et
SAVOY al.
Appeal of Mort ZIMMERMAN. S.
No. 76-1490. Appeals,
United States Court of
District of Columbia Circuit.
Argued Oct. 1977. July 14,
Decided
Rehearing Denied July questions peti- Admittedly, case to the district court because in the contentions raised factual, explore conclusory. largely rehearing and to tion for are somewhat involved are however, If, support prejudice plaintiffs may lack factual them work substantial here government opportunity by denying in sufficient to show involvement them the both sides develop program, through will the district court the core of further in- the relevant facts dismissing justified stipulation the suit. then be vestigation, discovery Only can a record satisfactory such a district court. court A less would be far course degree of adequately judge NIH’s permit plaintiffs to elaborate their contentions study. supplementa- rehearing of the UGDP court. involvement However, “core” this Such evidence, adducing should cut not believe we I do tion would but would more consist closely proffer, plaintiffs to show the resemble for the off all avenues requisite degree designed permit government re- us to assess whether involvement study, more initiating directing mand lieu of affirmance would ap- gesture. rehearing. I that this than a formal believe therefore I voted directly remanding proach is inferior to