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Government Accountability Project v. Food & Drug Administration

United States District Court, District of Columbia

August 26, 2016



          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 the agency's view, if that data point was released, anyone who knew the identity of the sole sponsor would necessarily also know that sponsor's sales or distribution total for domestic, injection-administered sulfa drugs in 2009. (See Def.'s Mem. at 22-23.) The FDA also redacted all data that were aggregated from just two distinct sponsors. For example, two sponsors provided all of the aminoglycosides designed for injection that were sold or distributed in 2009. (See Doc. 2 at 1.) The FDA asserts that, if that data point was released, each sponsor would know the volume that was attributable to its rival simply by subtracting its own volume from the aggregated figure. (See Def.'s Mem. at 24, 40.) Finally, the FDA redacted any data that were aggregated from three or more distinct sponsors where other publicly available data would reveal the sales and distribution data of two or fewer distinct sponsors. For example, while two routes of administration for domestic lincosamides (intramammary and feed) had just one sponsor and were redacted on that basis (see Doc. 2 at 1), two other routes for domestic lincosamides (injection and water) had three or more sponsors (see id.), which meant that, on the fact of the document, the data related to the injection and water routes should have been publicly released. However, according to the FDA, other publicly available information (specifically, the 2009 Revised Summary Report) includes a grand total for domestic sales and distribution of lincosamides. (See 2009 Summary Report at 33-60.) Thus, the agency reasoned, if the lincosamide injection and water totals in Document 2 are released, a competitor could take the grand total from the Summary Report, subtract from it the injection and water totals as revealed in Document 2, and discover the total for lincosamides designed for intramammary and feed, which stem from a single sponsor. (See Garcia-Malene Decl. ¶ 34(a).)

         B. Procedural History

         The FDA and GAP filed cross-motions for summary judgment on the issue of whether Exemptions 3 and 4 justified Document 2's redactions in 2013, and the Court held a hearing on those motions on June 5, 2014. This case was then stayed at the request of both parties while the FDA determined whether or not the figures in Document 2 were accurate. (See Consent Mot. to Stay Litigation, ECF No. 19; Minute Order of August 5, 2014.) The FDA disclosed an updated and revised version of Document 2 (see Joint Status Report, ECF No. 22, at 1), the stay was lifted, and the parties re-filed cross-motions for summary judgment in early 2015.[2]

         In its motion for summary judgment, the FDA argues that Section 105 of ADUFA is a withholding statute within the meaning of Exemption 3, and that its language prohibits the disclosure of the information that the FDA has withheld. (See Def.'s Mem. at 16-27.) With respect to Exemption 4, the FDA contends that the redacted information is confidential commercial data, the disclosure of which would cause substantial competitive injury. (See Id. at 27-43.) For its part, GAP argues that Section 105 of ADUFA is not a withholding statute under Exemption 3 (see Pl.'s Mem. at 11-20), and that even if it were a withholding statute, the FDA has applied it too broadly here (see Id. at 20-25). GAP also urges the Court to conclude that Exemption 4 does not cover the redacted information because Defendants have not shown that the information would cause substantial competitive harm. (See Id. at 24-40.)

         On January 5, 2015, the Animal Health Institute, a trade association of companies that develop and manufacture animal medications, moved to intervene in this action in order to protect its members from the “substantial competitive harm” that would allegedly accompany “public disclosure of the annual sales volume of [their] medications[.]” (Mem. in Supp. of AHI's Mot. to Intervene, ECF No. 23-1, at 2.) The Court granted AHI's motion (see Mem. Op. & Order, ECF No. 37), and AHI subsequently filed its own motion for summary judgment, supporting the FDA's redactions on the basis of Exemption 4 (see AHI's Mot.; AHI's Mem. at 29-45.)

         All three parties' cross-motions have now been fully briefed and are ripe for this Court's review.


         FOIA “generally requires the disclosure, upon request, of records held by a federal government agency[.]” Sciacca v. Fed. Bureau of Investigation, 23 F.Supp.3d 17, 25 (D.D.C. 2014) (alteration in original) (internal quotation marks omitted) (quoting Judicial Watch, Inc. v. U.S. Dep't of the Treasury, 796 F.Supp.2d 13, 18 (D.D.C. 2011)); see 5 U.S.C. § 552(a)(3)(A). However, FOIA also includes nine exemptions that permit agencies to withhold information from disclosure. See Judicial Watch, 796 F.Supp.3d at 23. These exemptions are to be construed narrowly, see Dep't of the Air Force v. Rose, 425 U.S. 352, 361 (1976), and the government bears the burden of demonstrating that any withheld information falls within the claimed exemptions, see Maydak v. Dep't of Justice, 218 F.3d 760, 764 (D.C. Cir. 2000).

         A. FOIA Exemption 3

         Under Exemption 3, an agency may withhold information “specifically exempted from disclosure by statute[, ]” provided that the statute either (1) “requires that the matters be withheld from the public in such a manner as to leave no discretion on the issue, ” or (2) “establishes particular criteria for withholding or refers to particular types of matters to be withheld[.]” 5 U.S.C. § 552(b)(3).[3] These conditions are disjunctive; a statute need satisfy only one of them to qualify under Exemption 3. See Pub. Citizen, Inc. v. Rubber Mfrs. Ass'n, 533 F.3d 810, 813 (D.C. Cir. 2008). However, “[b]efore a court inquires into whether any of the [two statutory] conditions [for withholding information] are met . . . it must first determine whether the statute is a withholding statute at all by deciding whether it satisfies ‘the threshold requirement that it specifically exempt matters from disclosure.'” Id. at 813-14 (emphasis in original) (quoting Reporters Comm. for Freedom of the Press v. U.S. Dep't of Justice, 816 F.2d 730, 734 (D.C. Cir. 1987)).

         To determine whether a statute qualifies as a withholding statute as required, courts look to “the language of the statute on its face[, ]” Zanoni v. U.S. Dep't of Agric., 605 F.Supp.2d 230, 236 (D.D.C. 2009), and they do not defer to an agency's interpretation of the statute, see Reporters Comm., 816 F.2d at 735, rev'd on other grounds, 489 U.S. 749 (1989); cf. Rubber Mfrs. Ass'n, 533 F.3d at 814 (noting that all parties, including the Department of Transportation, had agreed that “[j]udicial deference is neither sought nor owed to the agency's interpretation” of a statute's nature under Exemption 3 (alteration in original) (citation omitted)). Only if a statute meets the threshold requirement must a court consider whether either of the two conditions articulated in 5 U.S.C. § 552(b)(3)(A) is satisfied. See Rubbers Mfrs. Ass'n, 533 F.3d at 815; Zanoni, 605 F.Supp.2d at 236.

         B. FOIA Exemption 4

         FOIA Exemption 4 protects from disclosure “trade secrets and commercial or financial information obtained from a person and privileged or confidential[.]” 5 U.S.C. § 552(b)(4). No party in the instant case argues that this case involves trade secrets, and GAP does not contest that the information in Document 2 is commercial and obtained from a person-the sole dispute is whether the information is “privileged or confidential.” (See Pl.'s Mem. at 25-26; Def.'s Mem. at 27 & n.18.) Courts employ different tests to determine whether information is confidential, depending in part on whether the initial disclosure of the information was voluntary or compulsory. Where a party is required to submit the information to the government, such information is confidential under Exemption 4 “if disclosure of the information is likely . . . (1) 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.” Nat'l Parks & Conservation Ass'n v. Morton (Nat'l Parks I), 498 F.2d 765, 770 (D.C. Cir. 1974) (footnote omitted). “[F]or the government to preclude disclosure based on a competitive injury claim, it must prove that the submitters ‘(1) actually face competition, and (2) substantial competitive injury would likely result from disclosure.'” Niagara Mohawk Power Corp. v. U.S. Dep't of Energy, 169 F.3d 16, 18 (D.C. Cir. 1999) (quoting Nat'l Parks & Conservation Ass'n v. Kleppe (Nat'l Parks II), 547 ...

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