Court Opinion

ID: 9465294
Source: CourtListenerOpinion
Date Created: 2023-08-05 00:41:52.899861+00
Date Added: 2024-06-11T17:39:05.611206
License: Public Domain

BAZELON, Circuit Judge,
dissenting:
Plaintiffs seek disclosure of the raw data of a federally-sponsored research project, the University Group Diabetes Program (UGDP). The UGDP data are locked in a bank vault in Maryland in the custody of the UGDP program coordinator. For the majority, this means they are not agency “records” subject to disclosure under the Freedom of Information Act (FOIA). With all due respect, I cannot agree.
In my view, factors other than possession are relevant in determining whether the UGDP data are agency “records.” The Federal Government has provided all of the funding for the UGDP; the Government has an unrestricted right of access to the data; and importantly, the Government has extensively relied on the UGDP study and data in regulatory action affecting the treatment of diabetes. I think these factors cumulatively establish a significant degree of federal involvement with the UGDP raw data. Accordingly, I would hold that they are agency “records.”
I.
The Freedom of Information Act requires federal agencies to disclose all “records,” 5 U.S.C. § 552(a)(3),1 that do not fall within one of nine exemptions. Id. § 552(b)(l)-(9). No definition of the term “records” is found in either the Act or the legislative history.2 The case law, focusing almost exclusively on the exemptions, sheds little light on this *1141term.3 We are thus left with little direct guidance in attempting to elucidate a key provision of the Act.
The majority does not discuss the difficulties involved in defining agency “records.” It simply asserts, with little supporting rationale, that the crucial question is whether the documents have been “created” or “obtained” by a federal agency.4 In adopting this approach, the majority joins with the federal defendants and the district court in looking to such factors as property rights and possession in defining agency “records.”5 I have no objection to title or custody as relevant criteria. I do object, however, to a test based on only some of many possibly relevant factors, with little justification offered for the primacy of these factors. The place to start in determining the scope of agency “records” is not with assertion, but with an examination of the policies of the FOIA.
There can be no doubt about the basic goals of the Freedom of Information Act. As the Senate Report put it, the fundamental premise of the Act is that “the public as a whole has a right to know what its Government is doing.” S.Rep.No.813, 89th Cong., 1st Sess. 5 (1965). FOIA was designed, in the words of the Report, “to establish a general policy of full agency disclosure unless information is exempted under clearly delineated statutory language. . . . ” Id. at 3. In the House, Congressman after Congressman rose to speak in support of the policy underlying the bill. This was, as they variously put it, the right to the public “to information relating to the actions and policies of Federal agencies,” 112 Cong.Rec. 13655 (1966) (remarks of Rep. Hall); “to know the facts about the operation of their government,” id. at 13657 (remarks of Rep. Reid); “to be fully informed about the policies and activities of the Federal Government,” id. at 13648 (remarks of Rep. Faschell). These statements suggest the need for a broad definition of agency “records”: broad *1142enough to let the public know everything “its Government is doing;” to illuminate all “policies and activities of the Federal Government.”
The principle that “the disclosure requirement be construed broadly . . .,” Soucie v. David, 448 F.2d 1067, 1080 (D.C.Cir.1971), is also rooted in the structure of FOIA. Before FOIA was enacted, the public information section of the Administrative Procedure Act allowed agencies to withhold information “in the public interest,” or “for good cause shown,” or if the person seeking the information was not “properly and directly concerned.” 5 U.S.C. § 1002 (1964). These broad exemptions created what was in effect a “withholding statute,” not a “disclosure statute..”6 To remedy this situation, Congress enacted a statute containing a general disclosure section and nine narrowly drawn exemptions. The disclosure section provided that “any person” could have access to any agency “record,” without having to state a reason for wanting the information. And the exemptions were drafted to provide “definitive guidelines”7 as to what information could be withheld. To avoid new loopholes, Congress expressly limited the grounds for nondisclosure to'those specified in the exemptions.8 The objective was to “make it clear beyond doubt that all materials of the Government are to be made available to the public by publication or otherwise unless explicitly allowed to be kept secret by one of the exemptions in [§ 552(b)].” S.Rep.No. 813, supra at 10 (emphasis added in part).
Both the purpose and the structure of FOIA point to a broadly inclusive definition of agency “records” — a definition encompassing “all materials of the Government.” I seriously doubt that common law notions of property or custody can define the totality of such records. In my view, the appropriate approach under the statute is to examine all the relevant circumstances surrounding the creation, preservation, and use of particular records. If this analysis reveals a significant degree of federal involvement with the records,9 then they should be considered agency “records” subject to FOIA.
II.
Plaintiffs emphasize three forms of federal involvement with the UGDP research data: federal funding of the data, federal access to the data, and federal reliance on the data in administrative decisionmaking. We need not decide whether one of these factors, or even two of these factors in combination, would be sufficient to make the UGDP data agency “records.” Where all three factors are present, however, I think these materials are clearly agency “records.”
A. Government Funding
One hundred percent of the UGDP funding was provided by the National Institute *1143of Arthritis, Metabolism, and Digestive Diseases (NIAMDD), one of the institutes of the National Institutes of Health. Federal funding is significant for FOIA purposes for two reasons. First, funding of scientific research is a federal activity, and FOIA was enacted to allow the public to obtain information about all federal activities — including the expenditure of money. As one Congressman put it, FOIA was intended in part to enhance the rights and responsibilities of the voting public by making it possible for them to know “what their Government is doing with their money.” 112 Cong.Rec. 13659 (1966) (remarks of Rep. Gurney); accord 110 Cong.Rec. 17088 (1964) (remarks of Sen. Dirksen).
Federal funding of the UGDP is also important because funding brings with it significant Government control over the use, maintenance, and disposition of the UGDP raw data. This can be seen by examining HEW regulations governing the relationship between the Government and the grant recipient. Under these regulations, the grantee is obliged to retain “financial records, supporting documents, statistical records, and all other records pertinent to an HEW grant” for a period of three years after receiving the grant. 42 C.F.R. § 74.20. If the granting agency determines that any of the records generated by the grantee have “long term retention value,” the agency may order the records transferred to the Government for permanent custody. Id. § 74.20(b). At all times, the Government has the right of access to “any books, documents, papers, and records of the grantee” for the purpose of making “audit, examination, excerpts and transcripts.” Id. § 74.23(a). The regulations further require that the grantee retain all “[ljaboratory notes, related technical data and information” that pertain to a patentable invention, and make them available to HEW upon request. Id. § 52,22. And if the grantee copyrights a publication resulting from the grant, the regulations give the Government a royalty free, nonexclusive license “to reproduce, translate, publish, use, disseminate, and dispose of such materials and to authorize others to do so.” Id. § 52.23. While these provisions probably fall short of establishing full federal ownership of the UGDP data, see Gov. Br. at 26-31, they do establish, I think, that the Government has a substantial degree of control over the use and disposition of the UGDP records.
B. Government Access
Under the HEW grant regulations, the Government has an apparently unlimited right of access to the UGDP raw data. 45 C. F.R. § 74.23(a) provides:
HEW and the Comptroller General of the United States, or any of their duly authorized representatives, shall have access to any books, documents, papers, and records of the grantee which any of them determine are pertinent to a specific HEW grant, for the purpose of making audit, examination, excerpts and transcripts.10
HEW is permitted to “examine” and “excerpt” not only the financial records of the UGDP, but also raw research records. This is demonstrated by the fact that when the FDA conducted a scientific audit of the UGDP, portions of the raw data were examined by government investigators, copied, and then retained by the agency. Gov. Supp. Memo, of Dec. 5, 1977.
The Government’s right of access to the UGDP raw data is important for FOIA purposes since it establishes the basis for Government compliance with FOIA requests. Obviously, the Government must be able to obtain copies of requested agency “records” quickly and without legal impedi*1144ment.11 For example, if the Government had to purchase certain data, or subpoena certain records to comply with a FOIA request, these materials might not be considered agency “records.” We need not decide this question, for no such barrier is involved here. The Government can exercise its right of access to the UGDP data at any time and for any reason. To be sure, greater inconvenience may be involved in obtaining copies of documents not in the immediate custody of the agency. But, as the Government concedes, agency “records” need not be located within the physical confines of the agency. Gov. Br. at 20 n. 32. Records may be bailed to a privately-owned warehouse, loaned to a private entity, or may have been sold or donated to the Government but not delivered. In terms of ease of compliance with FOIA, these types of situations are indistinguishable from the present case.12
C. Government Reliance
Probably the strongest link between the UGDP data and the Federal Government is found in the extensive history of federal reliance on the UGDP study and data in regulatory action dealing with the treatment of diabetes. This reliance must be viewed against the background of intense controversy surrounding the UGDP ever since the study’s first conclusions were published in 1970.13
Release of the UGDP’s initial findings, suggesting a possible correlation between oral hypoglycemic drugs and cardiovascular mortality, had a profound impact.14 Professional conferences were convened, articles were published, and scientific studies were undertaken with the hope of evaluating the UGDP conclusions and determining their validity. The medical and scientific communities eventually divided along pro- and anti-UGDP lines. Supporters of the UGDP cited the study’s cost, duration, broad patient base, and sophisticated design as confirming the validity of the findings.15 Critics of the UGDP, on the other hand, pointed to alleged inadequacies in study design, *1145methodology, and execution.16 The controversy was compounded when a UGDP investigator, Dr. Angela Bowen, resigned from the study, challenging the integrity of the program director and suggesting a possible manipulation of the data base to reach results unfavorable to one of the drugs under study.17
Despite all the uncertainty about the validity of the UGDP study, and the inability of skeptical scientists and physicians to examine the raw data, the Federal Government has twice relied on the UGDP findings in regulatory action affecting a large segment of the public. In 1975, the Commissioner of the Food and Drug Administration (FDA) proposed new labeling requirements for oral hypoglycemic drugs used in the treatment of diabetes. 40 Fed. Reg. 28587 (1975). The Federal Register notice of the proposed warning stated in part:
The judgment of the Commissioner that changes must be made in the labeling of the oral hypoglycemic drugs to reflect the findings of the UGDP study is well known. .
The warning proposed in this labeling is based primarily on a thorough review and evaluation of the UGDP study. .
The Commissioner reaffirms his view that the UGDP study is an adequate and well-controlled clinical trial, which is the most extensive and detailed examination of the long-term administration of hypoglycemic agents yet undertaken.
The Commissioner believes that the UGDP study is a validly conducted trial and accepts the opinion of the Biometric Society committee and other experts that the increased cardiovascular mortality found in this trial cannot reasonably be attributed to scientific shortcomings in the study.
Id. at 28591.18 A clearer affirmation and reliance on the UGDP study is hard to imagine.
*1146Later, in 1977, Secretary Califano of HEW declared phenformin, an oral hypoglycemic drug, an “imminent hazard to public health” under § 505(e) of the Food and Drug Act, 21 U.S.C. § 355(e), and suspended approval of all new drug applications for this drug. The Secretary indicated that he was relying to a considerable extent on the statistical evidence gathered by the UGDP. The order stated that “[t]he FDA, which is experienced in interpreting and analyzing incidence figures for adverse reactions, has examined [the UGDP] statistics and concluded that the incidence figures are scientifically valid.” Order of the Secretary Suspending Approval at 11 (July 25,1977).19
Significantly, the proposed labeling change and suspension of phenformin were not undertaken solely on the basis of the published studies of the UGDP. In addition, the Federal Government has twice exercised its right of access to the UGDP raw data to verify the validity of the UGDP findings. When the initial controversy over the UGDP erupted, NIAMDD retained an independent group of biostatisticians, the Biometric Society, to review the UGDP. The Society was given access to the UGDP raw data for this purpose. After conducting a partial audit, it published a report indicating support for the UGDP findings.20 Several years later, prior to the suspension of new drug applications for phenformin, the FDA conducted its own audit of the UGDP. Details of this audit are sketchy, but the federal defendants admit that the FDA examined and copied at least a sample of the UGDP data in the course of its examination of the study. Gov.Supp.Mem. of Dec. 5, 1977 at 2.
These Government-sponsored or conducted audits are of considerable importance. By examining the UGDP raw data at first hand, the Government has apparently satisfied itself that the UGDP results are sound. In other words, the Government has relied directly on the UGDP raw data in the course of formulating official Government policy. As such, these data are precisely the sort of documents Congress intended to be disclosed under FOIA. SDC Development Corp. v. Mathews, supra n. 3, at 1119-20.21
*1147III.
The majority cryptically asserts that a finding that the UGDP raw data are agency “records” would interfere with the “autonomy” of federal grant recipients. The exact meaning of this is unclear. I do not maintain, nor do plaintiffs argue,22 that the UGDP is a federal “agency.” Consequently, no suggestion has been made that all of the various duties and responsibilities of a federal agency should be imposed on the UGDP. The only question before us is whether the UGDP raw data are agency “records” of HEW. An affirmative answer to this question would require HEW — not the UGDP — to obtain copies of these records in response to plaintiffs’ FOIA request. No direct interference with the manner or method in which a grantee conducts its research would result.
Perhaps the majority’s reference to “autonomy” means to suggest that scientific activity would be chilled by the knowledge that data produced under a federal grant could, in limited circumstances, become agency “records.” This has been advanced elsewhere as a policy reason for not finding the UGDP data to be agency “records.”23 On closer examination, however, I think even this concern carries little force.
The notion that a chilling effect could result from subjecting the records of federal grantees to disclosure could refer to one of three things. First, it could refer to the possibly inhibiting effect of a visit to the laboratory by a federal official executing a FOIA request. As a basis for restricting FOIA, I find this implausible in the extreme. The inconveniences occasioned by an infrequent FOIA request would be no greater than those currently created by conditions attached to the grant, including the possibility of Government inspection.24 Yet these burdens appear to have had an imperceptible effect on the enthusiasm for federal research grants.
Secondly, the chilling effect notion could refer to the danger that unscrupulous scientists would use FOIA to appropriate valuable research data for their own credit — or profit. This is a legitimate concern, and if all grantee research records were subject to FOIA it could conceivably deter some scientists from seeking federal grants. But the danger of misappropriation is minimal where, as here, the Government has relied on scientific records in the course of its decisionmaking. Government reliance will likely be limited to cases where the results of the study have been previously published or announced. Thus, whatever weight this concern is entitled to in other contexts, it is of little significance where the element of reliance is present.
Finally, federal grant applicants might be inhibited by having methodological or investigatory flaws in their work uncovered through a FOIA request. If this is the danger the majority seeks to avoid under the guise of protecting grantee “autonomy,” then it is a sad day for both the scientific community and the Freedom of Information Act. The essence of the scientific community, I had thought, is the commitment to the advancement of scientific truth by subjecting findings and conclusions to the “exacting scrutiny of fellow ex*1148perts.”25 Moreover, where scientific data bear the earmarks of agency “records” subject to FOIA, it would be the height of irony to deny disclosure on the ground that it could expose errors or frauds and thereby discourage those who do the work of the Government. FOIA was enacted in part to end the practice of withholding information “only to cover up embarrassing mistakes or irregularities. . . . ” S.Rep.No. 813, supra, at 3. To restrict the definition of agency “records” to accomplish the same end could only be regarded as a giant leap backwards.
I respectfully dissent.

. [E]ach agency, upon request for records which (A) reasonably describes such records and (B) is made in accordance with published rules stating the time, place, fees (if any), and procedures to be followed, shall make the records promptly available to any person.
5 U.S.C. § 552(a)(3) (1974). As originally enacted, this section provided:
[E]ach agency, on request for identifiable records made in accordance with published rules stating the time, place, fees to the extent authorized by statute, and procedure to be followed, shall make the records promptly available to any person.
The section was amended in 1974 to make clear that “[a] ‘description’ of a requested document would be sufficient if it enabled a professional employee of the agency who was familiar with the subject area of the request to locate the record with a reasonable amount of effort.” H.R.Rep.No.876, 93d Cong., 2d Sess. 5-6 (1974), U.S.Code Cong. & Admin.News 1974, pp. 6267, 6271.

. The 1967 Attorney General’s Memorandum does contain one sentence relevant to the definition of agency records. It says: “Subsection (c) [552(a)(3)] refers, of course, only to records in being and in the possession or control of an agency.” R. Clark, Attorney General’s Memorandum on the Public Information Section of the Administrative Procedure Act (1967) reprinted in Freedom of Information Act Source Book, S.Rep.No.82, 93d Cong., 2d Sess. 222 (1974) (emphasis added). Although the Attorney General’s Memorandum is a doubtful guide to congressional intent, see K. Davis, Administrative Law Treatise 117 (1970 Supp.), the fact that it refers to two criteria for defining agency “records” — possession or control — suggests a more inclusive approach than that adopted by the majority. I would also argue that the Attorney General’s Memorandum is consistent *1141with the result I would reach here, since in my view the Government involvement with the UGDP data amounts to “control.”

. But see Goland & Skidmore v. CIA, No. 76-1800 (D.C.Cir., May 23, 1978) (congressional hearing transcript in possession of agency not an agency record); SDC Development Corp. v. Mathews, 542 F.2d 1116 (9th Cir. 1976) (materials in medical reference library not agency records); Cook v. Willingham, 400 F.2d 885 (10th Cir. 1968) (per curiam) (presentence report in the hands of prison authority not an agency record); Ciba-Geigy Corp. v. Mathews, 428 F.Supp. 523 (S.D.N.Y.1977) (UGDP raw data not agency records); Nichols v. United States, 325 F.Supp. 130 (D.Kan.1971), aff’d, 460 F.2d 671 (10th Cir.), cert. denied, 409 U.S. 966, 93 S.Ct. 268, 34 L.Ed.2d 232 (1972) (physical evidence relating to assassination of President Kennedy not “records”). I exclude cases that turn on the definition of a federal “agency.” E. g., Soucie v. David, 145 U.S.App.D.C. 144, 448 F.2d 1067 (1971).

. Maj. op. at-of 190 U.S.App.D.C., at 1136 of 587 F.2d. Apparently, the majority would also recognize agency “records” where the Government is involved in the “core planning or execution” of a program, maj. op. at-n. 19,---of 190 U.S.App.D.C., at 1136 n.19, 1138-1139 of 587 F.2d; and where a federal agency has a duty to obtain records. Maj. op. at-of 190 U.S.App.D.C., at 1136 of 587 F.2d. But see concurring op. at-of 190 U.S.App.D.C., at 1139 of 587 F.2d.

. The district court found that
(1) no official or employee of the Department of Health, Education and Welfare (HEW), the National Institute of Health (NIH), the Food and Drug Administration (FDA), or the National Institute of Arthritis, Metabolism and Digestive Diseases (NIAMDD) is now or has ever been in possession of raw data in issue relating to the University Group Diabetes Program (UGDP) . . .; (2) the raw data in question is [sic] the property of the individual investigators and UGDP coordinating center and remains in the possession, custody and control of the UGDP study coordinating center . .; (3) neither the individual investigators nor the UGDP study coordinator is an ‘agency’ within the purview of the Freedom of Information Act, 5 U.S.C. § 552; and (4) consequently, the raw data in issue are not ‘agency records’ subject to the disclosure provisions of the Freedom of Information Act, 5 U.S.C. § 552(B) [552(a)(4)(B)],
Joint Appendix (J.A.) at 146-47 (footnote omitted).
The federal defendants’ position is that “the term ‘agency records’ in the Freedom of Information Act applies to ‘records’ in the possession of a federal agency or owned by an agency, or produced under the day-to-day supervision of an agency.” Gov. Br. at 17.

. S.Rep.No.813, supra at 5.

. Id. at 3.

. This section does not authorize withholding of information or limit the availability of records to the public, except as specifically stated in this section.
5 U.S.C. § 552(c) (1970).
I agree that in enacting FOIA Congress struck a deliberate balance between a policy of full disclosure and various countervailing policies. Maj. op. at-of 190 U.S.App.D.C., at 1137 of 587 F.2d. But the legislative history makes it abundantly clear that all of the competing policies Congress saw fit to recognize were to be accommodated through nine specific exemptions. It comes as a surprise, therefore, to learn that a policy not mentioned by Congress — that of preserving grantee “autonomy,” maj. op. at-of 190 U.S.App.D.C., at 1138 of 587 F.2d is to be realized through a restrictive definition of agency “records.”

. Another court that has grappled with whether the UGDP raw data are agency “records” concluded “that the goals and purposes of the Act would be served best by imposing a standard which calls for proof that the records were either Government-owned or subject to substantial Government control or use. In other words, it must appear that there was significant Government involvement with the records themselves in order to deem them agency records.” Ciba-Geigy Corp. v. Mathews, 428 F.Supp. 523, 529 (S.D.N.Y.1977). Although I disagree with Judge Tenney’s application of this standard, particularly his conclusion that the Government has not directly relied on the UGDP raw data, id. at 531, I have no quarrel with his statement of the standard itself.

. The Government may have access to the UGDP raw data under FDA regulations as well. 21 C.F.R. § 312.1(a)(12)(6)(e) gives the FDA the right of access to investigator’s records relating to investigational new drugs (INDs). The UGDP holds two INDs from the FDA. J.A. at 92. The federal defendants note that the regulation requires investigators to retain such records for only two years after administration of an IND has been discontinued, and assert that the UGDP discontinued use of its INDs more than two years ago. Gov. Br. at 34-35. However, there is no indication that the UGDP has in fact discarded the records, or that the FDA right of access is extinguished two years after administration of an IND stops.

. The Act requires agencies to determine whether to comply with a FOIA request “within ten days (excepting Saturdays, Sundays, and legal public holidays) after the receipt of any such request . . . 5 U.S.C. § 552(a)(6)(A) (1974). An additional 10 days is permitted in “unusual circumstances,” including “(i) the need to search for and collect the requested records from field facilities or other establishments that are separate from the office processing the request; . Id. § 552(a)(6)(B)(i) (emphasis added). The last provision appears to specifically contemplate that agency “records” can be found outside the custody of the agency.

. The majority’s assertion that NLRB v. Sears, Roebuck & Co., 421 U.S. 132, 161-62, 95 S.Ct. 1504, 44 L.Ed.2d 29 (1975) and Renegotiation Board v. Grumman Aircratt Engineering Corp., 421 U.S. 168, 192, 95 S.Ct. 1491, 44 L.Ed.2d 57 (1975) require more than a mere right of access to documents is without foundation. These cases stand only for the proposition that FOIA does not oblige an agency to write opinions. They say nothing about the duty to retrieve records that are reasonably described, admittedly exist, and are within an agency’s power to obtain.

. Klimt, Knatterud, Meinert & Prout, The University Group Diabetes Program: A Study of the Effects of Hypoglycemic Agents on Vascular Complications in Patients with Adult-Onset Diabetes, 19 Diabetes (Supp. 2) 747 (1970). Subsequent reports were published in Knatter-ud, Meinert, Klimt, Osborne & Martin, Effects of Hypoglycemic Agents on Vascular Complications in Patients with Adult-Onset Diabetes; IV. A Preliminary Report on Phenformin Results, 217 JAMA 777 (1971); Goldner, Knatter-ud & Prout, Effects of Hypoglycemic Agents on Vascular Complications in Patients with Adult-Onset Diabetes: III. Clinical Implications of UGDP Results, 218 JAMA 1400 (1971); Knat-terud, Klimt, Osborne, Meinert, Martin & Hawkins, A Study of the Effects of Hypoglycemic Agents on Vascular Complications in Patients with Adult-Onset Diabetes: V. Evaluation of Phenformin Therapy, 24 Diabetes (Supp. 1) 65 (1975).

. Some of the controversy surrounding the UGDP study is reviewed in the majority opinion at---of 190 U.S.App.D.C., at 1131— 1132 of 587 F.2d.

. See, e. g., Cornfield, The University Group Diabetes Program: A Further Statistical Analysis of the Mortality Findings, 217 JAMA 1676 (1971); Prout, Knatterud, Meinert & Klimt, The UGDP Controversy: Clinical Trials Versus Clinical Impressions, 21 Diabetes 1035 (1972).

. See, e. g., Feinstein, Clinical Biostatistics: An Analytical Appraisal of the University Group Diabetes Program (UGDP) Study, 12 Clin. Pharmacology, Therapeutics 167 (1971). Schor, The University Group Diabetes Program: A Statistician Looks at the Mortality Results, 217 JAMA 1671 (1971).

. Dr. Bowen testified as follows before FDA at the public hearings on the proposed labeling change for oral hypoglycemic drugs:
An even more troublesome aspect has not been as well explored. This involves the matter of personal integrity and scientific honesty of one key member of the group. This question was actively considered both privately and openly among the investigators as early as 1968. It has also been asked publicly since that time. The question that the FDA must now ask and hopefully answer is “were the data that were gathered in the field accurately and honestly recorded and reported from the coordinating center in Baltimore?” I fully recognize that this is a serious allegation but there is basis for reasonable doubt. You will recall that this was a double blind study. Investigators did not know what medication a patient was taking. Data were simply recorded and sent along to the biostatistician at the coordinating center. We then received a printout of the cumulative results. Therefore if one was told that a given death or other side effect occurred in a tolbutamide patient it was taken on faith because the investigator never knew for sure. [Tolbutamide is an oral hypoglycemic drug and a competitor of phenformin.] It did not occur to me to question this state of affairs until 1968 when the first allegation was made that the death rate was higher in the tolbu-tamide group. At the same meeting another investigator revealed that the biostatistician, Dr. Klimt, was a paid consultant to U.S. Vitamin, the then makers of phenformin. This was at first denied, then acknowledged. A spirited discussion followed during which the potential for abuse under such circumstances was discussed at length. This ended with the demand from the New York delegation that an independent review of the data be undertaken by outside statisticians. Dr. Klimt threatened to resign if this was done. This threat did not meet with universal disapproval, but a compromise was finally reached in which a review would be done but Dr. Klimt would be permitted to choose the reviewers! Drs. Cornfield and Brown were his choices. It is my understanding that they simply reviewed the numbers and methods sent to them by the coordinating center and that raw data were not used even then. This episode caused a rift of major proportions among the investigators.
J.A. at 130-31.

. The Commissioner of FDA recognized that “[f]rom the time the results of the UGDP study were first reported, the study was subjected to intense criticism by both clinicians and statisti*1146cians.” 40 Fed.Reg. 28588. He conceded that “a wide-spread belief had developed among many physicians that the UGDP study was somehow flawed in terms of its design and execution, and therefore could not serve as a proper basis for a warning to the medical profession.” Id.
The agency therefore decided to postpone implementation of the warning until [review of the UGDP study by a committee of the Biometrics Society] was published. Since the UGDP study was the basis for the proposed warning, the Commissioner believed that this independent review of the statistical validity of the study should be available to all interested persons before taking definitive action. The review by the committee of the Biometrics Society required extensive reanalysis of the data in the UGDP study and was not published until February 10, 1975.
Id. at 28589.
The Biometrics Society audit reconfirmed the Commissioner’s belief in the need for regulatory action based on the UGDP.
Although the [UGDP] has shortcomings, which might be expected in any clinical trial of this complexity, the shortcomings do not invalidate the central finding that there appears to be an increased risk of cardiovascular mortality associated with the administration of tolbutamide and of phenformin to maturity-onset diabetic patients, compared to treatment with diet alone or diet plus insulin. This conclusion has in the past been reached independently by the UGDP investigators, the FDA, and the Biometrics Society committee, and is again affirmed by the Commissioner. Other clinical trials of these oral hypoglycemic drugs are not comparable to the UGDP study and provide insufficient evidence to negate the findings of the UGDP study.
Id. at 28591.

. The quoted passage refers to statistics from “all available sources,” Order at 11, but it is clear from the context that the UGDP is included. The UGDP is also referred to at pp. 8, 38, 40-41, 46, 63 and 66.

. Committee for the Assessment of Biometric Aspects of Controlled Trials of Hypoglycemic Agents, Report of the Committee for the Assessment of Hypoglycemic Agents, 231 JAMA 583 (1975).

. In emphasizing the Government’s reliance on the UGDP study and data, I do not imply that the court should give weight to plaintiffs’ “need” for the UGDP raw data, or to plaintiffs’ position as litigants in the phenformin suspension proceedings. Maj. Op. at---of *1147190 U.S.App.D.C.., at 1134 of 587 F.2d. See NLRB v. Sears, Roebuck & Co., 421 U.S. 132, 143 n. 10, 95 S.Ct. 1504, 44 L.Ed.2d 29 (1975). My point is simply that, because of the Government’s reliance, the UGDP data have been absorbed into the federal decision-making process. This factor, together with the factors previously mentioned — federal funding and federal right of access — satisfies me that the UGDP raw data are agency “records.” They should therefore be potentially available for disclosure to all members of the public.

. Plaintiffs do not challenge the district court’s ruling, see n. 4 supra, that the UGDP is not a federal “agency.” Pet. Br. at 28 n. 7.

. Ciba-Geigy Corp. v. Mathews, supra n. 3 at 530.

. As noted above, HEW grant regulations already give the Government an unlimited right to inspect grantee records. See pp.-- - of 190 U.S.App.D.C., pp. 1142-1143 of 587 F.2d, supra. This right was in fact exercised in this case when the FDA audited the UGDP data.

. R. Merton, The Sociology of Science 275 (1973); see also B. Barber, Science and the Social Order 89 (1952).