Government Accountability Project v. Food & Drug Administration, Civil Action No. 2012-1954

Background

Plaintiff Government Accountability Project (GAP) filed a FOIA request for 2009 sales data of antimicrobial drugs labeled for use in food-producing animals; FDA produced two documents with redactions and only redactions to Document 2 remain in dispute.
ADUFA §105 (21 U.S.C. §360b(l)(3)) requires sponsors to report annual antimicrobial sales and directs the Secretary to publish summary reports with limits (e.g., no independent reporting of classes with fewer than three sponsors; protect confidential business information).
Document 2 provides 2009 kilogram volumes by antimicrobial class, market (domestic/export), and route of administration, and notes the number of sponsors per cell; FDA redacted cells that reflect single sponsors, aggregates of two sponsors, or aggregates of three-or-more when other public data would permit back-calculation of a smaller sponsor group.
FDA invoked FOIA Exemptions 3 and 4 to justify redactions; AHI (industry intervenor) supports Exemption 4; GAP contends ADUFA §105 is not an Exemption 3 withholding statute and that Exemption 4 cannot be shown to prevent disclosure.
The Court held ADUFA §105 is not a withholding statute under FOIA Exemption 3 because its text and structure limit its non‑disclosure language to the Secretary’s mandated public summaries, not to FOIA disclosures.
On Exemption 4 (confidential commercial information), the Court found defendants proved the market is competitive but a genuine dispute of material fact exists whether disclosure of the 2009 data would likely cause substantial competitive harm; thus summary judgment for any party was denied.

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether ADUFA §105 is a statutory withholding rule under FOIA Exemption 3	§105 only limits content of the Secretary’s required public summary reports, not all disclosures; thus it is not an Exemption 3 withholding statute	§105’s limits (e.g., not independently reporting classes with <3 sponsors; protecting CBI) bar disclosure generally and qualify as an Exemption 3 withholding statute	Court: Held §105 is not a withholding statute for Exemption 3; its restrictions apply to the Secretary’s mandated summaries, not as a blanket FOIA bar
Whether the redacted data are exempt under FOIA Exemption 4 (confidential commercial information)	Disclosure would not likely cause substantial competitive harm; data are from 2009 and may be stale; a single year is insufficient to build current models	Disclosure would likely cause substantial competitive injury: reveals market share, enables market re-entry, obviates costly market research, and exposes production/capacity/pricing sensitivity	Court: Defendants proved actual competition, but there is a genuine dispute of material fact whether disclosure would likely cause substantial competitive injury; summary judgment denied
Whether FDA’s redaction methodology (single sponsor, two-sponsor aggregates, avoiding back-calculation) is permissible under Exemption 4	Overbroad and unjustified given Exemption 4’s substantial-harm requirement and data age	Necessary to prevent competitors from inferring individual sponsor volumes and causing competitive harm	Court: Did not decide on permissibility—denied summary judgment due to factual dispute over likelihood of substantial competitive harm
Appropriate disposition at summary judgment stage	Grant disclosure to GAP	Maintain redactions	Court: Denied all summary judgment motions; factual development/resolution needed on Exemption 4 issue

Key Cases Cited

Pub. Citizen v. Rubber Mfrs. Ass’n, 533 F.3d 810 (D.C. Cir.) (statute that limits agency’s mandated reports does not necessarily constitute an Exemption 3 withholding statute)
Reporters Comm. for Freedom of the Press v. U.S. Dep’t of Justice, 816 F.2d 730 (D.C. Cir.) (threshold inquiry whether a statute specifically exempts matters from disclosure for Exemption 3)
Nat’l Parks & Conservation Ass’n v. Morton, 498 F.2d 765 (D.C. Cir.) (Exemption 4 confidentiality test for compelled disclosures: impairment of government’s ability to obtain info or likely substantial competitive harm)
Niagara Mohawk Power Corp. v. U.S. Dep’t of Energy, 169 F.3d 16 (D.C. Cir.) (to invoke Exemption 4 on competitive-harm grounds, agency must show actual competition and likely substantial competitive injury)
Consumer Prod. Safety Comm’n v. GTE Sylvania, Inc., 447 U.S. 102 (U.S.) (Exemption 3 can apply where statutory text unambiguously bars disclosure in all contexts)