Gov't Accountability Project v. Food & Drug Admin.

• Decision Date: 26 August 2016
• Docket Number: No. 12-cv-1954 (KBJ),12-cv-1954 (KBJ)
• Citation: 206 F.Supp.3d 420
• Parties: GOVERNMENT ACCOUNTABILITY PROJECT, Plaintiff, v. FOOD & DRUG ADMINISTRATION, Defendant.
• Court: U.S. District Court — District of Columbia

206 F.Supp.3d 420

GOVERNMENT ACCOUNTABILITY PROJECT, Plaintiff,

v.FOOD & DRUG ADMINISTRATION, Defendant.

No. 12-cv-1954 (KBJ)

United States District Court, District of Columbia.

Signed August 26, 2016

Karen J. Gray, Sarah L. Nash, Government Accountability Project, Washington, DC, for Plaintiff.

Fred Elmore Haynes, John G. Interrante, Patricia K. McBride, U.S. Attorney's Office for the District of Columbia, Washington, DC, for Defendant.

MEMORANDUM OPINION

KETANJI BROWN JACKSON, United States District Judge

Plaintiff Government Accountability Project ("GAP") is a non-profit organization whose mission includes "enhanc[ing] overall food integrity by facilitating truth-telling and transparency." (Compl., ECF No. 1, ¶ 3.) To that end, GAP has requested documents from the Food and Drug Administration ("FDA" or "Defendant") under the Freedom of Information Act ("FOIA"), 5 U.S.C. § 552 et seq. , concerning total sales of antimicrobial drugs labeled for use in food-producing animals during the year 2009. (See Pl.'s Statement of Material Facts ("Pl.'s SMF"), ECF No. 41-1, ¶¶ 1–2.) In response, the FDA eventually turned over two responsive documents, with certain redactions. (See id. ¶¶ 5–6.) The only remaining dispute is whether the information redacted from the second document was properly withheld pursuant to one of FOIA's exemptions. (See Pl.'s Mem. in Opp. to Defs.' Mots. for Summ. J. & in Supp. of Cross-Mot. for Summ. J. ("Pl.'s Mem."), ECF No. 41, 2–40, at 3.)¹

Before this Court at present are the parties' cross-motions for summary judgment, as well as a motion for summary judgment from Intervenor-Defendant Animal Health Institute ("AHI"). (See Def.'s Renewed Mot. for Summ. J. ("Def.'s Mot."), ECF No. 32, 1–3; Intervenor-Def. Animal Health Institute's Mot. for Summ. J. ("AHI's Mot."), ECF No. 40, 1–2; Pl.'s Cross-Mot. for Summ. J. ("Pl.'s Mot."), ECF No. 41, 1.) GAP asserts that the redactions are improper (see generally Pl.'s Mem.), but the FDA maintains that the redacted information properly falls under FOIA Exemptions 3 and 4. (See generally Def.'s Mem. in Supp. of Def.'s Mot. ("Def.'s Mem."), ECF No. 32, 9–45.) AHI agrees with the FDA, and offers its own arguments that Exemption 4 applies. (See generally Intervenor-Def. Animal Health Institute's Mem. in Supp. of Mot. for Summ. J. ("AHI's Mem."), ECF No. 40, 14–46.)

As explained below, this Court concludes that FOIA Exemption 3, which protects information "specifically exempted from disclosure by statute[,]" 5 U.S.C. § 552(b)(3), does not cover the redacted information because Section 105 of the Animal Drug and User Fee Amendments of 2008—the statute that the FDA invokes—is not an exemption statute. See 21 U.S.C. § 360b(l )(3). Exemption 4, which protects "trade secrets and commercial or financial information obtained from a person and privileged or confidential[,]" 5 U.S.C. § 552(b)(4), may well cover the information at issue, but there is a dispute of material fact regarding whether the release of the information would cause substantial competitive harm, as that exemption requires. Therefore, at this stage, summary judgment is not warranted in favor of any party, and all three motions must be DENIED . A separate order consistent with this Memorandum Opinion will follow.

I. BACKGROUND

A. Basic Facts

Antimicrobial drugs are used in food-producing animals for a variety of purposes, including to treat and prevent disease and to promote growth and weight gain. (See Decl. of Michael J. Blackwell ("Blackwell Decl."), Ex. 1 to Pl.'s Mot., ECF No. 41-2, ¶ 9.) Some members of the public are concerned that the overuse of such drugs may harm public health by creating antimicrobial-resistant bacteria that might subsequently infect humans. (See id. ) But data on the use of antimicrobial drugs in food-producing animals is hard to come by, making it difficult to study the link between such drugs and antimicrobial resistance. (See id. ¶ 10.)

The Animal Drug and User Fee Amendments of 2008 ("ADUFA"), 110 Pub. L. 316, 122 Stat. 3509, codified at 21 U.S.C. § 360b(l )(3), requires that sponsors of antimicrobial drugs used in animals submit an annual report to the Secretary of Health and Human Services containing "the amount of each antimicrobial active ingredient in the drug that is sold or distributed for use in food-producing animals." 21 U.S.C. § 360b(l )(3)(A). This report must include, among other things, the amount of each antimicrobial active ingredient sold or distributed, and this information must reflect certain specified variables: (1) "container size, strength, and dosage form"; (2) "quantities distributed domestically and ... exported"; and (3) "dosage form, including, for each such dosage form, a listing of the target animals, indications, and production classes that are specified on the approved label of the product." Id. § 360b(l )(3)(B). A portion of this data is made available to the public in the form of annual summary reports, subject to certain statutory restrictions. See id. § 360b(l )(3)(E) ; (2009 Summary Report, Ex. 5 to Decl. of Gorka Garcia-Malene ("Garcia-Malene Decl."), ECF No. 32-1, 33–60; Def.'s Mem. at 11 n.1).

As part of its mission to promote food quality through transparency, GAP filed a FOIA request in February of 2011, seeking certain data that were not included in the summary reports. This initial FOIA request sought

(1) printed copies of all educational and outreach materials that FDA has prepared in order to inform and assist antimicrobial drug sponsors in fulfilling their duty to report the amount of antimicrobial active ingredient in their drugs that have been sold or distributed for use in food-producing animals pursuant to [Section] 105 of the Animal Drug User Fee Amendments of 2008; (2) FDA's data for use of antimicrobial drugs in food-producing animals in 2009 as broken down by container size, strength, and dosage form; and (3) FDA's data for use of antimicrobial drugs in food-producing animals in 2009 as broken down by class of animal.

(Pl.'s SMF ¶ 2.) The FDA produced documents in response to the first part of GAP's request in May of 2011; one month later, in June, the agency notified GAP that it was withholding documents with respect to the remaining parts of the request on the basis of Exemption 4. (See Garcia-Malene Decl. ¶¶ 6–7; Pls.' Mem. at 2.) GAP appealed that determination in July of 2011, and the FDA denied the appeal one year later. (See Compl. ¶ 23.) GAP then filed the instant complaint, in December of 2012, seeking to challenge the FDA's withholding determination. (See id. ¶¶ 33–36.)

Meanwhile, GAP modified portions of its FOIA request. (See Compl. ¶ 21; Garcia-Malene Decl. ¶ 8.) Most notably, GAP altered the second and third parts of the request to indicate that it desired "aggregated data concerning the amount of antimicrobial active ingredient sold for each class of antimicrobial drugs, rather than data concerning sales or distribution by each individual sponsor[.]" (Compl. ¶ 21 (emphasis added); see also Pl.'s SMF ¶ 4.) The FDA conducted a search based on this new request and located two responsive documents, known for the purposes of this case as "Document 1" and "Document 2." (Pl.'s SMF ¶ 5.) The agency produced both documents with redactions (id. ¶ 6), and at this point, GAP is not challenging the scope or adequacy of the FDA's search, nor the redactions that the agency made to Document 1 (see Pl.'s Mem. at 3). Rather, the only remaining dispute between the parties is the legitimacy of the redactions in Document 2. (See id. )

Document 2 lists the volume (in kilograms) of the active ingredients for all antimicrobial drugs sold and distributed in 2009, broken down based on three characteristics: the market within which the drug is distributed (e.g., domestic or export); the route of the drug's administration (e.g., injection or topical); and the drug's antimicrobial class (e.g., aminoglycosides or tetracyclines). (See Ex. to Notice of Filing ("Doc. 2"), ECF No. 21-1; AHI's Mem. at 24.) The document also indicates, for each particular antimicrobial class within a route and a market, whether the drugs in that class had one, two, or three or more sponsors in 2009. (See Doc. 2 at 1.) Finally, the document records the total volume of active ingredients for antimicrobial drugs sold or distributed by the type of market, and the route of administration within that market. (See id. ) For example, according to the document, 22,957 kilograms of macrolides designed for injection were sold or distributed domestically in 2009, coming from three or more distinct sponsors. (See id. ) And, overall, there were 388,518 total kilograms of antimicrobial drugs designed for injection sold or distributed domestically in 2009. (See id. )

Significantly for present purposes, the FDA has invoked FOIA Exemptions 3 and 4 to redact many of the data points in Document 2. To be specific, the FDA asserts that it has redacted: (1) "all individualized sales and distribution data (i.e., data from a single, distinct sponsor)"; (2) "all sales and distribution data comprised of aggregated data of two distinct sponsors"; and (3) "sales and distribution data comprised of aggregated data of three of more distinct sponsors" if, through simple arithmetic using public data the agency has already released, such data could reveal aggregated sales and distribution data of one or two distinct sponsors. (Def.'s Mem. at 13.) According to the FDA, these redactions reflect the agency's concern about potential revelations to industry competitors regarding the sales/distribution volume of a particular class/route/market combination that is attributable to a particular sponsor. (See id. at 22–27; 39–41.)

As a practical matter, the FDA's redaction analysis appears to have worked as follows. As noted above, the FDA first redacted all data from a single specific sponsor. There was only one sponsor in 2009 for domestic sulfas designed for injection, for example (see Doc. 2 at 1), and in...