Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca10-87-02495/USCOURTS-ca10-87-02495-0/pdf.json

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

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PUBLISH 

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Umted StM(t§ v-~ic ,,.,{ Appeals 

Tenth Circuit 

JUN 2 2 1990 

UNITED STATES COURT OF APPEALS 

FOR THE TENTH CIRCUIT 

.ROBERT L. HOECK.ER 

Clerk 

CELIA ANDERSON, 

Plaintiff-Appellant, 

v. 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES; MARGARET 

HECKLER, Secretary, 

Department of Health and 

Human Services; FOOD AND 

DRUG ADMINISTRATION; and 

DR. FRANK YOUNG, M.D., 

Commissioner, Food and 

Drug Administration, 

Defendants-Appellees, 

and 

DOW CORNING CORPORATION, 

Defendant/Intervenor-Appellee 

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Nos. 86-2246 

86-2495 

Appeal from the United States District Court 

for the District of Utah 

(D.C. No. C-84-0861J} 

Daniel F. Bertch of Robert J. Debry & Associates (Robert J. Debry 

of Robert J. Debry & Associates, with him on the brief}, Salt Lake 

City, Utah, for Plaintiff-Appellant. 

Burt A. Braverman of Cole, Raywid & Braverman, Washington, D.C. 

(Susan Paradise Baxter and Kenneth A. Grant of Cole, Raywid & 

Braverman, Washington, D.C., Ray R. Christensen of Christensen, 

Jensen & Powell, Salt Lake City, Utah, and Harvey Steinberg of Dow 

Corning Corporation, Midland, Michigan, with him on the brief}, 

for Defendant/Intervenor-Appellee. 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 1 
Before HOLLOWAY, Chief Judge, BARRETT, and EBEL, Circuit Judges. 

EBEL, Circuit Judge. 

2 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 2 
I C 

This appeal concerns plaintiff-appellant Celia Anderson's 

attempt under the Freedom of Information Act (''FOIA"), 5 U.S.C. 

§ 552, to compel defendant-appellee Food and Drug Administration 

(''FDA'') to disclose certain documents submitted to the FDA by 

defendant-intervenor Dow Corning Corporation. The district court 

granted summary judgment to defendants, holding that the requested 

documents contain confidential information that is exempt from the 

disclosure requirements of the FOIA. We affirm in part, reverse 

in part, and remand. 

The following issues are raised on appeal: (1) whether 

Exemption 4 of the FOIA, 5 U.S.C. § 552(b)(4), allowed the FDA to 

refuse to disclose all of the documents at issue; (2) whether 18 

u.s.c. § 1905, 21 U.S.C. § 306j(c), or 21 u.s.c. § 33l(j) justify 

nondisclosure of the documents pursuant to Exemption 3 of the 

FOIA, 5 u.s.c. § 552(b)(3); and (3) whether the district court 

should have vacated its judgment pursuant to Federal Rule of Civil 

Procedure 60(b)(3). 

FACTS 

Appellant sued Dow in state court for injuries allegedly 

caused by an injection of liquid silicone manufactured by Dow. 1 

In connection with her state suit, appellant submitted a FOIA 

request to the FDA in order to obtain over 16,000 pages of 

documents that Dow had submitted to the FDA concerning Dow's 

liquid silicone, which is still in the testing phase and for which 

1 Liquid silicone is used by plastic surgeons to correct facial 

disfigurement. 

3 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 3 
( ' 

Dow has been seeking FDA approval for over 20 years. The FDA 

rejected appellant's request. 

The documents at issue consist of over 16,000 pages contained 

in a Notice of Claimed Investigational Exemption for a New Drug 

("IND"), a New Drug Application ("NDAII), and an Application for an 

Investigational Device Exemption (''IDE"), all submitted by Dow to 

the FDA. An IND is filed as a precqndition to clinical testing of 

a drug. 21 U.S.C. § 355(i), 21 C.F.R. § 312.50. Once the IND is 

approved by the FDA, the sponsor of the new drug can ship the drug 

for use in clinical tests, the results of which are reporte0 to 

- che FDA. 21 C.F.R. § 312.10. When adequate evidence of complete 

clinical testing has been submitted to the FDA, the sponsor may 

file an NDA, the approval of which is required before a drug can 

be marketed in interstate commerce. 21 u.s.c. § 355(a), (b), and 

(j). The NDA must contain extensive data regarding the 

composition, manufacture, and effects of the drug, including full 

reports of clinical and nonclinical investigations, adverse 

reaction reports, and published articles on the effectiveness of 

the drug. 21 C.F.R. § 314.50. 

After Dow filed its IND for injectable silicone, amendments 

to the Food, Drug, and Cosmetic Act were passed, giving the FDA 

regulatory authority over medical devices. As a result of those 

amendments, injectable silicone was reclassified from a drug to a 

medical device, and Dow was required to convert its IND to an 

Application for an Investigational Device Exemption ("IDE"), the 

medical device equivalent of an IND. See 21 u.s.c. § 360j(g); 21 

4 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 4 
C.F.R. § 812.20. Dow's IDE essentially contains the research that 

has been carried out by Dow under its IND and NDA. 2 

Appellant brought suit in the district court seeking 

disclosure of the documents in the IND, NOA and IDE pursuant to 

the FOIA. Dow intervened and has defended the action on behalf of 

the FDA. Dow prepared an eighty-five page "Vaughn index 113 listing 

roughly 16,000 documents at issue by in-house number. Across from 

the entries was a brief description of the document(s) and a coded 

explanation referring to one of seven specific categories of 

information "for which confidentiality is claimed:" 

1. Manufacturing and processing information, including 

formulations, chemistry and quality assurance 

procedures. 

2. Protocols, including forms for reporting results of 

research and informational materials supplied to 

clinical investigators. 

3. Preclinical test data. 

4. Clinical test data including adverse reaction 

reports and interim data. 

5. Patient information. 

6. Contractor and consultant identities. 

7. Marketing, sales and customer information. 

Vaughn Index at iv. In addition to those brief explanations, Dow 

filed as an exhibit the affidavit of Robert T. Rylee, II, a Vice 

2 Instead of an NOA, a sponsor of a new medical device must file 

a Premarket Approval Application ("PMA") as a condition to 

obtaining market approval. 21 u.s.c. § 360e, 21 C.F.R. § 814.20. 

3 A Vaughn index is a compilation prepared by the government 

agency (or intervenor) listing each of the withheld documents and 

explaining the asserted reason for its nondisclosure. See Vaughn 

v. Rosen, 484 F.2d 820 (D.C. Cir. 1973), cert. denied 415 U.S. 977 

(1974). See generally, Franklin & Bouchard, Guidebook to the 

Freedom of Information and Privacy Acts, §l.15[6] (1990). 

5 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 5 
President and General Manager of Dow. In that affidavit, Mr. 

Rylee provided more thorough explanations of the seven 

justifications listed in the Vaughn index. However, Mr. Rylee's 

affidavit did not elaborate on the description or asserted 

justification for nondisclosure of the individual documents. 

For approximately half of the documents listed in the Vaughn 

index, no coded explanation entry appeared. Instead, Dow had 

written ''n/a" in the explanation column. In the introduction to 

the Vaughn index, Dow explained its reasons for not disclosing 

those documents for which no explanation had been offered: 

This index identifies portions of the documents at 

issue that are subject to withholding because they 

contain privileged or confidential commercial 

information or trade secrets within the meaning of 

Exemption 4 of the Freedom of Information Act, 5 u.s.c. 

§ 552, and the Trade Secrets Act, 18 u.s.c. § 1905. 

However, Dow Corning also asserts that all of the 

documents at issue, including documents or portions of 

documents that have not been identified in this index as 

falling within Exemption 4 or the Trade Secrets Act, are 

required to be withheld pursuant to Defendant FDA's 

statutory authority and implementing regulations. 

Vaughn Index at iv-v. 4 

The district court granted Dow's motion for summary judgment, 

determining .that there were no material facts in dispute and 

holding that the documents at issue are exempt from disclosure 

4 Dow also stated in the introduction to the index that it 

"believes that portions of the documents at issue not identified 

in this index are withholdable as intra- or inter-agency memoranda 

under FOIA Exemption 5 and companion statutory and regulatory 

provisions, and relies on Defendant FDA to identify such 

materials." It is not at all clear from the record and the 

parties' briefs if there are documents not identified in the 

Vaughn index which the appellant is seeking to have disclosed. 

However, because appellant does not assert on appeal that there 

are any such documents, and because Dow does not argue on appeal 

that any of the disputed documents are covered by Exemption 5, we 

need not address either of those questions. 

6 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 6 
pursuant to Exemptions 3 and 4 of the FOIA, 5 U.S.C. § 552(b)(3) & 

(4), and are prohibited from disclosure under 18 u.s.c. § 1905, 

21 u.s.c. § 33l(j), and 21 u.s.c. § 360j(c). See R. Doc. 71 

(August 12, 1986 Order). 

Appellant subsequently obtained all of the documents at issue 

through discovery in her state court suit. The documents, 

however, are subject to a protective order entered in that suit 

that prohibits their use outside the litigation. Appellant still 

seeks the documents free from any restrictions, claiming that she 

wants to make the public aware of the dangers of silicone 

injections. See Appellant's Br. at 5. 

After appellant filed the first of these two appeals (No. 86-

2246), she discovered additional evidence which, in her view, 

indicated that Dow's documents did not contain trade secrets. 

Armed with the new evidence, appellant filed a motion to vacate 

the district court's judgment pursuant to Federal Rule of Civil 

Procedure 60(b)(3). The district court denied appellant's motion. 

She then filed the second of these appeals (No. 87-2495), 

challenging the district court's denial of her Rule 60(b)(3) 

motion. 

ANALYSIS 

Congress enacted the FOIA in 1966, and it became effective in 

1967, It generally provides that the public has a right of access 

, enforceable in court, to federal agency records, subject to nine 

specific exemptions. See 5 u.s.c. § 552. The basic purpose of 

the Act "is to ensure an informed citizenry, vital to the 

7 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 7 
functioning of a democratic society, needed to check against 

corruption and to hold the governors accountable to the governed." 

NLRB v. Robbins Tire & Rubber Co., 437 U.S. 214, 242 (1978). To 

achieve that goal, the FOIA is designed to "'pierce the veil of 

administrative secrecy and to open agency action to the light of 

public scrutiny."' Wren v. Harris, 675 F.2d 1144, 1145 (10th Cir. 

1982) (quoting Department of the Air Force v. Rose, 425 U.S. 352, 

361 (1976)). The FOIA is to be broadly construed in favor of 

disclosure, Alirez v. NLRB, 676 F.2d 423, 425 (10th Cir. 1982), 

and its exemptions are to be narrowly construed. Irons & Sears v. 

Dann, 606 F.2d 1215, 1219 (D.C. Cir. 1979), cert. denied, 444 U.S. 

1075 (1980). The federal agency resisting disclosure bears the 

burden of justifying nondisclosure. Alirez, 676 F.2d at 425. 

The FOIA contains nine exemptions from disclosure, set forth 

at Section 552(b). Those exemptions are exclusive under the Act. 

See 5 U.S.C. § 552(c); E.P.A. v. Mink, 410 U.S. 73, 79 (1973). 

The following two exemptions are relevant to this appeal: 

This section [requiring disclosure of government 

documents] does not apply to matters that are --

(3) specifically exempted from disclosure by statute . provided that such statute (A) requires that 

matters be withheld from the public in such a manner as 

to leave no discretion on the issue, or (B) establishes 

particular criteria for withholding or refers to 

particular types of matters to be withheld; 

(4) trade secrets and commercial or financial 

information obtained from a person and privileged or 

confidential .••• 

5 u.s.c. § 552(b)(3) and (4). 

8 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 8 
De Novo Review By the District Court 

When an action is brought under the FOIA to obtain 

information in the possession of a government agency, the district 

court must review de novo the agency's decision not to disclose 

the requested materials. See Desalvo v. I.R.S., 861 F.2d 1217, 

1221 (10th Cir. 1988). The district court must determine whether 

all of the requested materials fall within an exemption to the 

FOIA and may not simply conclude that an entire file or body of 

information is protected without consideration of the component 

parts. See United States Dept. of Justice v. Julian, 486 U.S. 1 

(1988); 5 5 u.s.c. § 552(b) ("Any reasonably segregable portion of 

a record shall be provided to any person requesting such record 

after deletion of the portions which are exempt under this 

subsection."); see also Federal Bureau of Investigation v. 

Abramson, 456 U.S. 615, 626-27 ( 1982) ( "Congress intended for 

courts to 'consider the nature of the particular document as to 

which exemption is claimed, in order to avoid the possibility of 

impermissible 'commingling' by an agency's placing in an 

investigatory file material that did not legitimately have to be 

5 In Julian, the Court held that Fed. R. Crim. P. 32(c) and the 

Parole Act were Exemption 3 statutes which in part prevented 

prison inmates from obtaining their presentence reports under the 

FOIA. Id. at 10-11. Applying the "reasonably segregable" 

requirement of 5 u.s.c. § 552(b) the Court concluded that although 

Rule 32(c) and the Parole Act "specifically exempt from disclosure 

any information in the report that relates to confidential 

sources, diagnostic opinions, and other information that may cause 

harm to the defendant or other third parties ... the remaining 

parts of the reports are not covered by this exemption [3], and 

must be disclosed unless there is some other exemption which 

applies to them." Id. at 9, 11. 

9 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 9 
kept confidential.''' (quoting NLRB v. Robbins Tire & Rubber Co., 

437 U.S. 214, 229-30 (1978)). 

In order to fulfill its obligation to review de novo the 

agency's decision not to disclose materials sought under the FOIA, 

a district court has a variety of options. "The FOIA allows the 

district court flexibility in utilizing in camera review of the 

disputed documents, indexing, oral testimony, detailed affidavits, 

or alternative procedures to determine whether a sufficient 

factual basis exists for evaluating the correctness of the 

[agency] determination in each case." Desalvo, 861 F.2d at 1222, 

n.6. Although a Vaughn index is an often-employed means for 

reviewing the agency decision, 6 if the index is insufficient, then 

the district court must utilize other procedures in order to 

develop an adequate factual basis for review of the agency action. 

"Where the agency affidavits merely parrot the language of the 

statute and are drawn in conclusory terms, the court's 

responsibility to conduct de novo review is frustrated." Carter 

v. United States Dept. of Commerce, 830 F.2d 388, 393 (D.C. Cir. 

1987) (quotations omitted). 

6 

The District Court may, in its discretion, order 

production of the [withheld] material or some sample 

thereof for in camera inspection .•.• Moreover, 

should the task of in camera inspection prove too 

burdensome, the court may allow appellant to engage in 

further discovery, or order the [agency] to supplement 

its Vaughn filings. 

Whether the District Court proceeds by ordering 

supplemental affidavits or by an in camera inspection of 

See supra note 3. 

10 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 10 
documents or samplings, it must ensure that it has an 

adequate foundation for review of the [agency's] 

withholding claims. 

King v. United States Dept. of Justice, 830 F.2d 210, 225-26 (D.C. 

Cir. 1987). A second problem which may require the district court 

to look beyond the Vaughn index and agency affidavits arises when 

there is evidence of agency bad faith. "[I]f information 

contained in the agency affidavits is contradicted by other 

evidence in the record--then, in camera inspection may be 

necessary to insure that agencies do not misuse the FOIA 

exemptions to conceal non-exempt information." Carter, 830 F.2d 

at 393; see Ingle v. United States Dept. of Justice, 698 F.2d 259, 

266 (6th Cir. 1983).7 

On appeal, the initial inquiry of the circuit court is 

whether the district court had an adequate factual basis upon 

which to base its decision. See King, 830 F.2d at 225. In 

addition, where the district court has granted summary judgment in 

favor of the government agency, we must review de novo the 

district court's legal conclusions that the requested materials 

are covered by the relevant FOIA exemptions. See Johnson v. 

United States Dept. of Justice, 739 F.2d 1514, 1517 (10th Cir. 

J984). 

7 The foregoing principles are applicable in cases such as this 

one where the existence of the documents or the file containing 

the information sought is known and is not contested and the only 

dispute is whether the documents are within one of the enumerated 

FOIA exemptions. Thus, we do not address the situation where the 

existence of the requested information is at issue. See~, 

National Cable Television Ass'n Inc., v. F.C.C., 479 F.2d 183 

(D.C. Cir. 1973). 

11 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 11 
In this case, the record upon which the district court based 

its conclusions consisted entirely of the Vaughn index and 

affidavit described above. The district judge ruled from the 

bench and did not discuss the individual bases for his ruling: 

THE COURT: Seems to me that the exemptions claimed by 

the party defendant acting through its surrogate, the 

intervenor, are appropriate exemptions justifying the 

non-disclosure at this time of the documents sought 

under both the provisions of the statute and the 

provisions of the regulation so that the cross-motion of 

the defendant, intervenor, will be granted. 

PLAINTIFF'S COUNSEL: Your Honor, if I may ask a 

question about your ruling. Does that ruling intended 

[sic] to encompass also the 50 percent of the documents 

that we talked about earlier where they say nonTHE COURT: Their motion is granted. 

See R. Vol.Vat 33. In a written order which followed, the 

district court stated that "[b]ased on the uncontested facts that 

appear of record and for the reasons stated in open court, the 

court concludes that the documents at issue are exempted from 

disclosure by exemptions 3 and 4 of the FOIA, 5 u.s.c. § 1905 and 

21 u.s.c. §§ 33l(j) & 360j(c)." Dist. Ct. Op. at 2. We now 

proceed to evaluate the adequacy of the record and the correctness 

of the district court's conclusions in the context of the 

individual exemptions at issue. 

12 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 12 
1. Exemption 4 

The district court held that many of the documents here are 

covered by Exemption 4 of the FOIA. By its terms, Exemption 4 

exempts from disclosure trade secrets and commercial or financial 

information that is privileged or confidential. "Like all FOIA 

exemptions, exemption 4 is to be read narrowly in light of the 

dominant disclosure motif expressed in the statute." Washington 

Post Co. v. United States Dept. of Health & Human Services, 865 

F.2d 320, 324 (D.C. Cir. 1989). 

A. Trade Secrets 

Appellant argues that not all of the documents at issue are 

trade secrets exempted from disclosure and that a document-bydocument review is required. We agree that a more particularized 

review of the documents (whether by in camera review, 

supplementation of the Vaughn index, review of more detailed 

affidavits, or otherwise) is required. 

Initially, we must decide upon the proper definition of 

the term "trade secrets" in Exemption 4. Appellees urge us to 

adopt the broad definition of "trade secrets" set forth in the 

first Restatement of Torts, § 757 comment b (1939): 

A trade secret may consist of any formula, pattern, 

device or compilation of information which is used in 

one's business, and which gives him an opportunity to 

obtain an advantage over competitors who do not know or 

use it .... A trade secret is a process or device for 

continuous use in the operation of the business. 

The FDA has adopted that definition at 21 C.F.R. § 20.6l(a): 

"A trade secret may consist of any formula, pattern, device, or 

compilation of information which is used in one's business and 

13 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 13 
which gives him an opportunity to obtain an advantage over 

competitors who do not know or use it." 

The D.C. Circuit rejected that broad definition in Public 

Citizen Health Research Group v. Food and Drug Administration, 704 

F.2d 1280 (D.C. Cir. 1983). That court concluded that the 

agency's interpretive regulation was not binding because "Congress 

has made clear both that the federal courts, and not the 

administrative agencies, are ultimately responsible for construing 

the language of the FOIA, see 5 U.S.C. § 552(a)(4}(B)(l976), and 

that agencies cannot alter the dictates of the Act." Id. at 

1287. 8 The court proceeded to explain that the Restatement 

definition was "inconsistent with the language of the FOIA and its 

underlying policies." Id. at 1288. Instead, the court decided 

that trade secrets should be defined in the narrower common law 

sense, as "a secret, commercially valuable plan, formula, process, 

or device that is used for the making, preparing, compounding, or 

processing of trade commodities and that can be said to be the end 

product of either innovation or substantial effort." Id. at 1288 

(footnote omitted). That definition requires that there be a 

"direct relationship" between the trade secret and the productive 

process. Id. 

We agree with the D.C. Circuit's narrow definition because we 

believe that it is more consistent with the policies behind the 

8 "No single agency is entrusted with FOIA's primary 

interpretation, and agencies are not necessarily neutral 

interpreters insofar as FOIA compels release of information the 

agency might be reluctant to disclose." Retired Railroad Workers 

v. Railroad Retirement Board, 830 F.2d 331, 334 (D.C. Cir. 1987); 

see infra note 17. 

14 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 14 
FOIA than the broad Restatement definition. Of the arguments put 

forth by that court in support of its construction, we find most 

compelling the observation that adoption of the Restatement 

definition of "trade secrets" would render superfluous the 

"commercial or financial information" prong of Exemption 4 because 

there would be no category of information falling within the 

latter but outside the former. Like the D.C. Circuit, we are 

reluctant to construe the FOIA in such a manner. "A statute 

should be construed so that effect is given to all its provisions, 

so that no part will be inoperative or superfluous, void or 

insignificant, and so that one section will not destroy another 

unless the provision is the result of obvious mistake or error." 

J. Sutherland, Statutes and Statutory Construction, § 46.06 at 104 

(C. Sands 4th ed. rev. 1984). 

Applying the narrower definition to this case, we must remand 

the case to the district court because we cannot tell if the 

district court applied that definition and because that court did 

not make sufficient findings for us to review on appeal. Neither 

the district court's ruling from the bench nor the subsequent 

written order make clear which documents the court believed were 

exempt as "trade secrets," and which documents were exempt on 

other grounds. Any attempt on our part to determine which of 

defendants' seven proposed classifications of the enormous number 

of documents at issue were adopted by the district court as trade 

secrets would be sheer speculation. Although we believe that the 

majority of documents which Dow sought to exclude under the 

descriptive category of "manufacturing and processing information, 

15 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 15 
including formulations, chemistry and quality assurance 

procedures" are probably within the narrow definition of trade 

secrets under Exemption 4, we cannot tell if the district court 

considered other documents to be trade secrets as well. The 

district court may have believed that documents which were 

withheld under the other six listed explanations 9 were also trade 

- secrets. Therefore, on remand the district court must review 

Dow's claims of exemption, applying the narrow definition of trade 

secrets, and make findings that adequately explain the basis of 

its ruling and that relate its rulings either to specific 

documents or to clearly described categories of documents that are 

drawn with sufficient precision so that all documents within a 

particular category are similar in nature. 10 

B. Commercial Information 

If not a trade secret, for Exemption 4 to apply the 

information must be "(a) commercial or financial, (b) obtained 

from a person, and (c) privileged or confidential." National 

Parks and Conservation Ass'n v. Morton, 498 F.2d 765, 766 (D.C. 

Cir. 1974). Although the documents at issue clearly satisfy the 

9 See supra text accompanying notes 3 and 4. 

10 The district court is entitled to considerably more 

assistance from the defendants than it received in this case. The 

burden of adequately describing the documents and of defining any 

narrowly-drawn categories that may be used to deal with similar 

documents as a group should normally be placed in the first 

instance on the agency or other party claiming protection for the 

documents requested. The district court's task is essentially one 

of review, but neither it nor the appellate court can adequately 

fulfill this function without more particularized descriptions 

than those that were provided here. 

16 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 16 
first two requirements, appellant argues that not all of the 

documents here are "privileged or confidential'' and that a 

document-by-document review is necessary to determine which 

documents are exempted from disclosure. Again, we agree that a 

more particularized review is required, though we leave selection 

of the best method to accomplish that to the district court's 

discretion. 

(1) Privilege 

Defendants contend that the documents at issue are 

''privileged" because they are protected by a state protective 

order which was entered pursuant to Utah Rule of Civil Procedure 

26(c)(7) in appellant's products liability action against Dow. 11 

We recognize that certain types of discovery privileges may 

constitute an additional ground for nondisclosure under FOIA 

Exemption 4. However, on the few occasions when this ground for 

exemption has been recognized under Exemption 4, the underlying 

privilege has been for privileges not otherwise specifically 

embodied in the language of Exemption 4 such as the attorneyclient privilege, see Miller, Anderson, Nash, Yerke & Wiener v. 

11 The Utah rule tracks the federal rule and provides as 

follows: 

Upon motion by a party or by the person from whom 

discovery is sought, and for good cause shown, the court 

in which the action is pending ... may make an order 

which justice requires to protect a party or person from 

annoyance, embarrassment, oppression, or undue burden or 

expense .•. that a trade secret or other confidential 

research, development, or commercial information not be 

disclosed or be disclosed only in a designated way. 

Utah R. Civ. P. 26(c)(7). 

17 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 17 
Department of Energy, 499 F. Supp. 767, 771 {D. Or. 1980), the 

attorney work product privilege, see Indian Law Resource Center v. 

Dept. of the Interior, 477 F. Supp. 144, 148 {D.D.C. 1979), and 

the confidential report privilege, see Washington Post Co. v. HHS, 

603 F. Supp. 235, 237-39 {D.D.C. 1985), rev'd on other grounds, 

795 F.2d 205 {D.C. Cir. 1986). However, recognition of a 

privilege for materials protected as a "trade secret or other 

confidential research, development or commercial information" 

pursuant to a protective order under Rule 26{c){7) would be 

redundant and would substantially duplicate Exemption 4's explicit 

coverage of "trade secrets and commercial or financial 

information." See Federal Open Market Committee v. Merrill, 443 

U.S. 340, 360 (1979). 12 Therefore, we hold that materials which 

are the subject of a protective order under rule 26{c){7) are not 

privileged for purposes of FOIA Exemption 4 because the 

determination of whether documents contain trade secrets under 

Exemption 4 is to be made solely by applying the express exemption 

for trade secrets and confidential commercial or financial 

information found in the exemption itself. 

12 In Federal Open Market Committee, the Court held that if the 

materials protected under Federal Rule of Civil Procedure 

26(c)(7), would be privileged under Exemption 5 of the FOIA. Id. 

at 356, 364. However, the Court made clear that one justification 

for its conclusion was the fact that adoption of such a privilege 

for Exemption 5 ''would not substantially duplicate any other FOIA 

exemption." Id. at 360. Because Exemption 4 already explicitly 

exempts tradesecrets and confidential commercial or financial 

information, it would provide a redundancy {and perhaps 

conflicting standards) to also allow trade secrets and 

confidential commercial or financial information to obtain exempt 

status through the separate ''privilege" language in Exemption 4. 

18 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 18 
If we were to adopt a contrary rule and establish that Rule 

26(c)(7) constitutes an ind~pendent ground of privilege under 

Exemption 4, then we would have to confront several complicated 

issues which we do not today address. For instance, we would have 

to decide the issue of whether federalism principles would be 

offended if a state court protective order were to be binding upon 

a federal court's FOIA decision. We would also have to determine 

whether the definition of ''trade secret or other confidential 

research, development or commercial information" under the state 

protective order employs the same definition as that to be used by 

a federal court in applying Exemption 4. Given the special 

considerations favoring disclosure under FOIA, it is not at all 

clear that the definitions utilized by a state.court under a state 

version of Rule 26(c)(7) would be the same as those governing the 

FOIA. 

Finally, we would need to determine how much relief would 

have to be granted under Rule 26(c)(7) before such relief rises to 

the level of a privilege. Rule 26(c)(7) authorizes a district 

court to establish protective orders within a wide range of 

alternatives. A protective order may completely bar discovery of 

trade secret materials or it may merely dictate the time, place 

and manner in which the discovery is to occur. It cannot be 

argued seriously that a Rule 26(c)(7) order merely limiting 

production of certain documents to a specified place renders those 

materials privileged for FOIA purposes. We do not read Federal 

Open Market Committee as establishing such an overly broad concept 

19 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 19 
of privilege in the Exemption 5 context. 13 Here, Dow was 

compelled to disclose to appellant all or much of the disputed 

materials, albeit with the requirement that their use be limited 

to that litigation. Such disclosure is inconsistent with ordinary 

concepts of privilege in which discovery is entirely prohibited. 

Moreover, this type of restriction on the use of discovery 

material is not extraordinary, as it is frequently entered upon 

joint stipulation of the parties and without the careful scrutiny 

that should be required if it is to have preclusive effect on a 

FOIA determination. In any event, becaause we hold that the term 

"privilege" in Exemption 4 does not encompass materials that are 

the subject of a limited protective order under rule 26(c)(7), we 

do not need to grapple with these difficult issues. 

(2) Confidential 

Appellees also contend that the information here is 

"confidential." Commercial or financial information is 

"confidential" for purposes of Exemption 4 if disclosure of the 

information is likely "(l) to impair the Government's ability to 

obtain necessary information in the future; or (2) to cause 

substantial harm to the competitive position of the person from 

whom the information was obtained." National Parks, 498 F.2d at 

13 In Federal Open Market Committee, the Court emphasized that 

"[u]nder the circumstances, we do not consider whether, or to what 

extent, [the documents at issue] would in fact be afforded 

protection in civil discovery. That determination must await the 

development of a proper record." Federal Open Market Committee, 

443 U.S. at 364. Thus, the Court contemplated that the degree of 

protection extended under Rule 26(c)(7) is a consideration to be 

factored in the determination of privilege. 

20 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 20 
770 (footnote omitted). 14 

As a preliminary matter, we must determine if there was a 

material fact in dispute on this issue precluding the entry of 

summary judgment. Appellant argues that the district court's 

entry of summary judgment in favor of defendants was improper 

because there was a dispute of material fact concerning whether or 

not Dow intended to market its silicone product. Appellant 

maintains that whether or not Dow intended to market the silicone 

is material to determining whether the disputed documents are 

"confidential" for purposes of FOIA Exemption 4. 

We review the district court's grant of summary judgment de 

novo applying the same legal standard used by the district court 

under Rule 56(c) of the Federal Rules of Civil Procedure. Osgood 

v. State Farm Mut. Auto. Ins. Co., 848 F.2d 141, 143 (10th Cir. 

1988). Summary judgment should be granted only if "there is no 

genuine issue as to any material fact and . . the moving party 

is entitled to judgment as a matter of law." Fed. R. Civ. P. 

56(c). When applying this standard, we are to examine the factual 

record and reasonable inferences therefrom in the light most 

favorable to the party opposing summary judgment. Gray v. 

Phillips Petroleum Co., 858 F.2d 610, 613 (10th Cir. 1988). 

14 On appeal, Dow urges us to adopt an additional consideration 

set forth in 9 to 5 Organization For Women Office Workers v. Board 

of Governors of the Federal Reserve System, 721 F.2d 1 (1st Cir. 

1983): whether disclosure would "harm an identifiable private or 

governmental interest which the Congress sought to protect by 

enacting exemption 4." Id. at 10. However, it appears from the 

record on appeal that this point was not raised before the 

district court. See R. Vol. II, Doc. 56 (Defendant-intervenor's 

Memorandum in Support of Motion For Summary Judgment). 

Accordingly, we will not address the issue for the first time on 

appeal. 

21 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 21 
If the moving party will bear the burden of persuasion 

at trial, that party must support its motion with 

credible evidence--using any of the materials specified 

in Rule 56(c)--that would entitle it to a directed 

verdict if not controverted at trial ••.• Such an 

affirmative showing shifts the burden of prodμction to 

the party opposing the motion and requires that party . to produce evidentiary materials that demonstrate 

the existence of a "genuine fact" for trial. 

Celotex Corp. v. Catrett, 477 U.S. 317, 331 (1986) (citation 

omitted). 

Dow, as intervenor, would bear the burden of persuasion at 

trial on the issue of whether the documents at issue are 

confidential under FOIA Exemption 4. In order to show substantial 

competitive injury, Dow must prove that it actually faces 

competition and that "substantial competitive injury would likely 

result from disclosure." National Parks and Conservation Ass'n v. 

Kleppe, 547 F.2d 673, 679 (D.C. Cir. 1976). Therefore, because 

Dow bears the burden of persuasion on the issue over which 

appellant maintains a material dispute of fact exists, we apply 

the principles of Celotex as described above. 

In support of its motion for summary judgment, Dow.relied on 

the following affidavit testimony of Robert T. Rylee II, VicePresident and General Manager of Dow: 

Dow Corning has always intended to actively pursue 

all marketing opportunities for injectable silicone once 

appropriate FDA clearances are obtained. For a brief 

period in the mid-1970's, it appeared that Dow Corning 

would encounter difficulties in obtaining ultimate FDA 

marketing approval. Therefore, during this brief 

period, Dow Corning had doubts whether marketing would 

ever be a possibility. These doubts account for 

statements made at that time, that marketing was not 

intended in the foreseeable future. Subsequently, these 

doubts were resolved with the establishment of a new 

FDA-approved clinical testing program. 

22 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 22 
Then and now, potential markets for injectable 

silicon exist not only in the United States but also 

abroad. When marketing approval is obtained, Dow 

Corning intends to market this product internationally 

as well as nationally. 

Rylee Affidavit at 20-21. 

Appellant maintains that the following evidence raised a 

question of material fact about whether Dow intends to market 

its· silicon product once it is approved. First, appellant. 

relies on a letter dated May 17, 1977 from A.H. Rathjen, a 

Senior Clinical Research Specialist for Dow, stating that 

"Dow has no intention now, or in the foreseeable future to 

actively seek FDA approval of the [liquid silicon product] 

nor does it have any present plans to market this product to 

the medical profession." See R. Vol. I., Doc. 50, Exhibit A. 

Appellant ~lso submitted a letter from Mr. Rathjen dated 

October 28, 1983 which states, in relevant part, as follows: 

[S]hortly after [a 1975 NOA submission to the FDA], 

Dow Corning elected voluntarily, without influence 

from any outside source, to withdraw our NOA. We 

realized that there w~re no regulations on the 

books that would allow us to control the 

distribution and therefore, there was nothing that 

would allow us to control the use, and prevent the 

misuse and abuse of the drug once it was approved 

for shipment through interstate commerce. 

Therefore, ... Dow Corning voluntarily withdrew 

the NOA. 

Id., Exhibit B (emphasis in original). Finally, appellant 

pointed to a third letter from Mr. Rathjen dated September 6, 

1977, in which he stated: "Dow Corning has no plans now or 

in the foreseeable future to market this drug." Id., 

exhibit C. 

23 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 23 
The district court correctly ruled that appellant's 

evidence did not give rise to a dispute of material fact 

precluding the entry of summary judgment. None of the above 

evidence conflicts with the statements of Mr. Rylee. The 

evidence is entirely consistent with Rylee's statements that 

in the late 1970's Dow did not have an immediate intent to 

market its silicon product. Appellant presented no evidence 

conflicting with Rylee's statements that Dow had the 

intention to market the silicon product when, and if, it 

obtained satisfactory marketing approval from the FDA. 

Therefore, the district court was correct in holding that 

there are no material facts in dispute. 15 

Although we agree with the district court that there 

were not any material facts in dispute precluding a ruling 

that some of the materials described in the Vaughn index were 

"confidential," we cannot determine from the record before us 

which documents the district court in fact believed to be 

"confidential." For the same reason that we are unable to 

evaluate the correctness of the district court's ruling on 

which of the listed documents constitute ''trade secrets" 

under Exemption 4, we must remand in order for the district 

15 Appellant argues that there is a second material fact in 

dispute concerning whether Dow made bona fide efforts to market 

liquid silicone and whether "Dow was illegally manipulating the 

regulatory process by 'studying' a drug it had no intent of 

marketing." We see no distinction between this alleged factual 

dispute and that discussed above. Both questions turn on whether 

Dow intends to market its liquid silicon product. Moreover, to 

the extent that appellant seeks to challenge the propriety of 

Dow's filings before the FDA, a FOIA action is not the proper 

place to raise such a claim. Cf. 21 u.s.c. § 360f(a). 

24 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 24 
court to clarify further which documents, if any, it believes 

are "confidential" within the meaning of Exemption 4. 16 In 

addition, should the district court determine that any of the 

documents are exempt because they contain confidential 

commercial or financial information such that disclosure 

would cause substantial harm to Dow's competitive position, 

the district court must make sufficient findings to support 

any such conclusion. 17 

2. Exemption 3 

As first enacted, Exemption 3 protected information 

"specifically exempted from disclosure by statute." 5 u.s.c. 

§ 552(b)(3) (1970). The Supreme Court interpreted that 

language as manifesting congressional intent to allow 

statutes that permitted the withholding of confidential 

information, and that had been enacted prior to the enactment 

of the FOIA, to remain unaffected by the disclosure mandate 

of the FOIA. Administrator, FAA v. Robertson, 422 U.S. 255, 

265 (1975). In Robertson, the Court specifically held that 

16 Even if the district court had made clear findings of which 

documents contained trade secrets and which contained confidential 

commercial or financial information, we would still need to remand 

for supplementation of the record. As discussed in the previous 

section, some of the descriptions are simply inadequate to enable 

the district court to engage in carefully scrutinizing the claims 

of exemption. 

17 As discussed in connection with our treatment of trade 

secrets, the district court may utilize categories in its analysis 

so long as the categories are narrowly drawn and adequately 

described. The burden of initially defining such categories and 

describing the documents within particular categories may, at the 

discretion of the district court, initiaily be placed on the 

defendants. 

25 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 25 
Section 1104 of the Federal Aviation Act of 1958, which 

allowed the FAA Administrator to withhold from the public any 

FAA material when he believed that "a disclosure of such 

information ... is not required in the interest of the 

public," was an Exemption 3 statute. 

Fearing that the Supreme Court's interpretation would 

allow agencies to evade the FOIA's disclosure policy, 

Congress effectively overruled Robertson in a 1976 amendment 

to Exemption 3. See H. R. Rep. 94-880, reprinted at 1976 

U.S. Code Cong. and Admin. News 2183, 2205 (1976). 

Exemption 3, as amended, now allows the withholding of 

information prohibited from disclosure by another statute 

only if the matters are "specifically exempted from 

disclosure by statute" and the statute either "(A) requires 

that the matters be withheld from the public in such a manner 

as to leave no discretion on the issue, or (B) establishes 

particu~ar criteria for withholding or refers to particular 

types of matters to be withheld." 5 U.S.C. § 552(b)(3). A 

statute falls within Exemption 3's coverage if it satisfies 

either one of those disjunctive requirements lettered "(A)" 

and "(B)". See American Jewish Congress v. Kreps, 574 F.2d 

624, 628 (D.C. Cir. 1978). 

We now examin~ the statutes relied upon by the district 

court to decide whether they are Exemption 3 statutes and, if 

so, whether they support the district court's decision. 

26 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 26 
A. 18 U.S.C. § 1905 

The Trade Secrets Act, 18 u.s.c. § 1905, is a general 

criminal confidentiality statute. It provides: 

Whoever, being an officer or employee of the United 

States or of any department or agency thereof, or agent 

of the Department of Justice as defined. in the Antitrust 

Civil Process Act (15 u.s.c. 1311-1314), publishes, 

divulges, discloses, or makes known in any manner or to 

any extent not authorized by law any information corning 

to him in the course of his employment or official 

duties or by reason of any examination or investigation 

made by, or return, report or record made to or filed 

with, such department or agency or officer or employee 

thereof, which information concerns or relates to the 

trade secrets, processes, operations, style of work, or 

apparatus, or to the identity, confidential statistical 

data, amount or source of any income, profits, losses, 

or expenditures of any person, firm, partnership, 

corporation, or association •.. shall be fined not 

more than $1,000, or imprisoned not more than one year, 

or both; and shall be removed from office or employment. 

18 u.s.c. § 1905 (emphasis added). 

The Supreme Court has not resolved the issue of whether 

Section 1905 is an Exemption 3 statute. See Chrysler v. Brown, 

441 U.S. 281, 319 n.49 (1979). 18 However, most lower federal 

courts that have considered the issue have concluded that§ 1905 

does not qualify as an Exemption 3 statute. ~, CNA Financial 

Corp. v. Donovan, 830 F.2d 1132, 1138 (D.C. Cir. 1987) (Section 

1905 does not satisfy either of the iequirernents of Exemption 3), 

cert. denied, 485 U.S. 977 (1988); Florida Medical Ass'n v. United 

States Dept. of Health, Education & Welfare, 479 F. Supp. 1291, 

1302 (M.D. Fla. 1979); United Technologies Corp. v. Marshall, 464 

18 In Chrysler, the Court stated that it was not deciding "the 

relative arnbits of Exemption 4 and§ 1905, or determining whether 

§ 1905 is an exempting statute within the terms of the amended 

Exemption 3." 441 U.S. at 319 n.49. The Court did indicate that 

Exemption 4 and§ 1905 may have the same practical scope of 

protection. Id. 

27 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 27 
F. Supp. 845, 851 (D. Conn. 1979); St. Mary's Hospital, Inc. v. 

Califano, 462 F. Supp. 315, 317 (S.D. Fla. 1978), aff'd sub nom. 

St. Mary's Hospital, Inc. v. Harris, 604 F.2d 407 (5th Cir. 1979); 

cf. General Elec. Co~ v. U.S. Nuclear Regulatory Commission, 750 

F.2d 1394, 1402 (7th Cir. 1984) (Section 1905 and Exemption 4 are 

coextensive); 9 to 5 Organization v. Board of Governors of Fed. 

Res., 721 F.2d 1, 12 (1st Cir. 1983) ("[I]f the government cannot 

prove that the requested documents are within FOIA exemption 4, 

their disclosure will not violate section 1905."). But see,~, 

Burroughs Corp. v. Brown, 501 F. Supp. 375, 382 (E.D. Va. 1980), 

rev'd on other grounds sub nom. General Motors Corp. v. Marshall, 

654 F.2d 294 (4th Cir. 1981). 

We agree with those courts holding that§ 1905 is not an 

Exemption 3 statute. First, we believe that the broad and illdefined wording of S 1905 fails to meet either of the requirements 

of Exemption 3. The prohibition in S 1905 against disclosure is 

not absolute, as required by subpart (A) of Exemption 3. Rather, 

it applies only insofar as disclosure is "not authorized by law." 

Also, Exemption 3's prohibition against disclosure does not 

categorize the information to be withheld and does not contain 

criteria for withholding, as required by subpart (B) of Exemption 

3. Second, the legislative history of the 1976 amendment of 

Exemption 3 clearly states that§ 1905 was not intended to qualify 

as a nondisclosure statute. For example, the House Report states: 

[T]he Trade Secrets Act, 18 U.S.C. S 1905, which relates 

only to the disclosure of information where disclosure 

is "not authorized by law," would not permit the 

withholding of information otherwise required to be 

disclosed by the Freedom of Information Act, since the 

disclosure is there authorized by law. 

28 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 28 
H. Rep. No. 94-880, 94th Cong., 2d Sess. 23 (1976), reprinted in 

1976 U.S. Code Cong. & Admin. News 2183, 2205 (1976). Therefore, 

we conclude that§ 1905, which is merely a general prohibition 

against unauthorized disclosure, does not support the district 

court's decision in this case. 

B. 21 U.S.C. § 360j(c) 

Another statute relied upon by the district court to justify 

nondisclosure is Section 360j(c) of the Medical Devices Act, 21 

u.s.c. § 360j(c), which provides: 

Any information reported to or otherwise obtained by the 

Secretary or his representative under section 360c, 

360d, 360e, 360f, 360h, 360i, or 374 of this title or 

under subsection (f) or (g) of this section which is 

exempt from disclosure pursuant to subsection (a) of 

section 552 of Title 5 by reason of subsection (b)(4) of 

such section shall be considered confidential and shall 

not be disclosed and may not be used by the Secretary as 

the basis for the reclassification of a device under 

serition 360c of this title from class III to class II or 

as the basis for the establishment or amendment of a 

performance standard under section 360d of this title 

for a device reclassified from class III to class II, 

except that such information may be disclosed to other 

officers or employees concerned with carrying out this 

chapter or when relevant in any proceeding under this 

chapter (other than section 360c or 360d of this title). 

Id. (emphasis added). 

The plain language of that section reveals that its scope of 

protection is coextensive with Section 552(b)(4) of the FOIA. 

Therefore, it does not provide independent justification for 

nondisclosure in this case. See Public Citizen Health Research 

Group v. FDA, 704 F.2d 1280, 1285 (D.C. Cir. 1983) (under 360j(c) 

"the confidential status of information is determined solely by 

reference to FOIA Exemption 4 11 ) (emphasis added). 

29 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 29 
c. 21 u.s.c. § 33l(j) 

Section 30l(j) of the Food, Drug, and Cosmetic Act, 21 u.s.c. 

§ 33l(j), provides: 

The following acts and the causing thereof are 

prohibited: 

(j) The using by any person to his own advantage, or 

revealing, other than to the Secretary or officers or 

employees of the Department, or to the courts when 

relevant in any judicial proceeding under this chapter, 

any information acquired under authority of [21 u.s.c. 

§§] 344, 348, 350a, 355, 356, 357, 360, 360b, 360c, 

360d, 360e, 360f, 360h, 360i, 360j, 374, 376, or 379 ... concerning any method or process which as a trade 

secret is entitled to protection. 

(Emphasis added.) Section 33l(j) applies to the information 

sought in this case because the information was obtained pursuant 

to statutes referenced in Section 33l(j): Dow's NDA documents 

were submitted to the FDA pursuant to 21 u.s.c. § 355, which 

requires NDA's and specifies their contents; the IND was filed 

pursuant to 21 U.S.C. § 355(i); and the IDE was filed pursuant to 

21 u.s.c. § 360j(g). 

Initially, we must determine whether Section 33l(j) is an 

Exemption 3 statute. We conclude that it is. First, we believe 

that the language of Section 33l(j) meets the requirement in 

subpart (A) of Exemption 3 because the prohibition against 

disclosure is absolute and applies to any information within its 

scope. Second, we believe that subpart (B) also is met because 

Section 33l(j) is specific as to the particular matters to be 

withheld. 

Having determined that Section 33l(j) qualifies as an 

Exemption 3 statute, we now must decide whether it is broader than 

30 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 30 
Exemption 4. We hold that it is not and consequently that it 

cannot provide any independent justification for nondisclosure in 

this case. The language in Section 33l(j) stating that it applies 

to information ''concerning any met~od or process which as a trade 

secret is entitled to protection" might be construed as affording 

broader coverage than the coverage of "trade secrets'' in Exemption 

4. However, we believe such an interpretation would be contrary 

to the well-established rules that the FOIA is to be broadly 

construed in favor of disclosure, Alirez v. NLRB, 676 F.2d 423, 

425 (10th Cir. 1982), and its exemptions are to be narrowly 

construed. Irons & Sears v. Dann, 606 F.2d 1215, 1219 (D.C. Cir. 

1979), cert. denied, 444 U.S. 1075 (1980). In light of those 

objectives, we believe the use of the term "concerning" should not 

be read as a broadening term. Rather, its presence in the section 

is simply necessary in order for Section 33lj to make sense by 

connecting the modifying phrase "information acquired under 

authority of [the various statutes]" with "any method or process." 

If anything, Section 33l(j) is arguably narrower than Exemption 4 

in that it is limited to information relating to methods or 

processes whereas Exemption 4 applies to all trade secret 

information. This, also, is probably a distinction without much 

of a difference since we have defined trade secret to be limited 

to a secret "used for the making, preparing, compounding, or 

processing of trade commodities." 

In summary, we hold that neither 18 u.s.c. § 1905, 21 u.s.c. 

§ 360j(c) nor 21 U.S.C. § 331j are broader than Exemption 4's 

protection of "trade secrets." However, the district court 

31 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 31 
,. 

apparently relied on these statutes as independent grounds 

justifying nondisclosure of those documents for which Dow had put 

forth no Exemption 4 explanation. 19 Therefore, on remand, the 

19 In ruling from the bench, the district court suggested that 

it might be relying on the FDA's regulations as a basis of 

nondisclosure under Exemption 3. However, because Exemption 3 by 

its terms references only statutory bases for withholding 

information any such reliance is misplaced. 

In assessing whether sections 360j and 33lj provide a basis 

for nondisclosure beyond that under Exemption 4, we need not defer 

to the FDA's regulations barring disclosure of any information 

contained in new drug files during the pendency of the 

application. See 21 C.F.R. §§ 314.430, 812.38. 

The D.C. Circuit has explained why agency interpretations of 

statutes are not entitled to any deference in determining whether 

the statute at issue is an Exemption 3 statute under the FOIA. 

See Reporters' Committee v. United States Dept. of Justice, 816 

F.2d 730 (D.C. Cir. 1987). In Reporters' Committee, the court 

began by noting that the Supreme Court has interpreted the 

language of exemption 3 requiring that a matter be "specifically 

exempted from disclosure by statute" as requiring that a matter be 

"explicitly" exempted. Id. at 734; Baldridge v. Shapiro, 455 U.S. 

345, 355 (1982). The court determined that if that was Congress' 

intent, then "[w]e must find a congressional purpose to exempt 

matters from disclosure in the actual words of the statute (or at 

least in the legislative history of the FOIA .•• )--not in the 

legislative history of the claimed withholding statute, nor in an 

agency's interpretation of that statute." Id. at 735 (citation 

omitted, emphasis added). The court concluded that Congress was 

well aware of the various ways a statute might be interpreted in 

determining whether it was an exemption 3 withholding statute but 

had selected the "plain meaning rule." Id. 

In Retired Railroad Workers Assoc. V: Railroad Retirement 

Board, 830 F.2d 331 (D.C. Cir. 1987), the D.C. Circuit reaffirmed 

the standard of review announced in Reporters' Committee and 

further explained why no deference to an administrative agency's 

interpretation was appropriate in an Exemption 3 FOIA case: "[n]o 

single agency is entrusted with FOIA's primary interpretation, and 

agencies are not necessarily neutral interpreters insofar as FOIA 

compels release of information the agency might be reluctant to 

disclose." Id. at 334; see also Lessner v. United States Dept. of 

Commerce, 827 F.2d 1333, 1335 (9th Cir. 1987) ("A basic policy of 

[the] FOIA is to ensure that Congress and not administrative 

agencies determines what information is confidential. Given the 

court's responsibility to ensure that agencies do not interpret 

the exemptions too broadly, ... deference appears inappropriate 

in the FOIA context. However, because our conclusion is the same 

under either approach, we need not resolve the standard of review 

issue here"). We have not found any cases to the contrary 

[Footnote continued •.• ] 

32 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 32 
district court will need to determine if those documents are 

exempt under Exemption 4 as either trade secrets or confidential 

commercial or financial information. 

Almost half of the documents listed in the Vaughn index had 

no accompanying explanation for why they should be withheld under 

Exemption 4. Although there are thousands of documents listed in 

the index without an accompanying explanation of why they are 

exempt, a survey of just a few examples demonstrates that it is 

highly unlikely that all of those documents will be exempt from 

disclosure under Exemption 4 as trade secrets or confidential 

commercial or- financial information: 

"Exhibit 4", text taken from The Plastic and 

Reconstructive Surgery Journal, Vol. 35, No. 2, 

including investigation of cutaneous response to 

Dimethypolysilokane in animals and humans. 

"Exhibit 611 , text taken from the Israel Medical Journal, 

titled "Malignant Tumor Formation Following 

Subcantaneous Injection Of Silicone Fluid In White 

Mice." 

Letter to the editor, The Lancet, re: silicone injection 

in mice. 

Vaughn Index at 4. Because materials such as these appear to be 

in the public domain, no meritorious claim of confidentiality can 

be made. See C.N.A. Financial Corp. v. Donovan, 830 F.2d 1132, 

1154 (D.C. Cir. 1987). Whether the district court orders 

supplementation of the Vaughn index, in camera inspection, or 

[ ... footnote continued] 

suggesting that any deference to an agency regulation is 

appropriate in deciding whether a statute is a withholding statute 

under FOIA exemption 3. But cf. King, 830 F.2d at 225-26 ("in an 

exemption 1 case the [FBI's] expert opinion on national security 

matters [should be given] the substantial weight to which it is 

entitled"). 

33 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 33 
., 

proceeds by some other method, it will need to scrutinize 

carefully all of the documents being withheld and it must satisfy 

itself as to each document that there is a satisfactory ground 

under Exemption 4 to withhold such document. It then must set 

forth its findings with particularity so that they can be 

meaningfully reviewed on appeal. 

3. Rule 60(b)(3) Motion 

While appellant's appeal concerning the district court's 

grant of summary judgment was pending, appellant filed a motion to 

vacate the district court's judgment pursuant to Rule 60(b)(3) of 

the Federal Rules of Civil Procedure. The district court denied 

that motion, and appellant filed a separate appeal of that denial. 

Rule 60(b)(3) provides authorization to vacate a judgment for 

"fraud ... misrepresentation, or other misconduct of an adverse 

party." We review the district court's decision denying relief 

under that rule for abuse of discretion. See Zimmerman v. Quinn, 

744 F.2d 81, 82 (10th Cir. 1984). 

Appellant contended in her brief that the district court 

erred in refusing to vacate the judgment because appellant has 

discovered new evidence showing that Dow committed fraud in 

obtaining summary judgment. At oral argument, however, 

appellant's counsel made it clear that appellant was no longer 

relying on fraud. Thus, appellant is apparently relying on 

"misrepresentation" or "other misconduct." The new evidence is 

recent deposition testimony by Mr. Rathjen obtained by appellant 

through discovery in her state court suit. Mr. Rathjen testified 

34 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 34 
that, to his knowledge, Dow presently does not have any present 

plans to market liquid silicone even if Dow obtained FDA approval. 

That testimony is arguably inconsistent with the testimony of 

Dow's marketing director, which states that Dow does now intend to 

market the product, although it did not pursue that goal for a 

period in the late 1970's. Appellant argues that the research 

director's testimony is evidence that the documents at issue do 

not contain trade secrets and, as such, it should preclude a grant 

of summary judgment for defendants. 

We affirm the district court's denial of the Rule 60(b)(3) 

motion because appellant has not presented "clear and convincing 

proof" of fraud, misrepresentation, or misconduct. See Devargas 

v. Montoya, 796 F.2d 1245, 1258 (10th Cir. 1986), overruled on 

other grounds, Newcomb v. Ingle, 827 F.2d 675 (10th Cir. 1987). 

Seemingly inconsistent testimony does not necessarily suggest 

I 

fraud, misrepresentation, or other misconduct. The district court 

reasonably could have concluded that the testimony merely 

represented different opinions or different degrees of knowledge 

regarding Dow's intentions. We also conclude that the district 

court did not abuse its discretion in refusing to conduct a 

hearing on ·this issue, in light of appellant's lack of evidence. 

We hereby AFFIRM IN PART, REVERSE IN PART, and REMAND for 

proceedings consistent with this opinion. 

35 

Appellate Case: 87-2495 Document: 01019871112 Date Filed: 06/22/1990 Page: 35