Am. Chemistry Council, Inc. v. U.S. Dep't of Health & Human Servs.

Decision Date13 February 2013
Docket NumberCivil Action No. 12–1156 (JEB).
Citation922 F.Supp.2d 56
PartiesAMERICAN CHEMISTRY COUNCIL, INC., Plaintiff, v. UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, et al., Defendants.
CourtU.S. District Court — District of Columbia

OPINION TEXT STARTS HERE

Kent A. Yalowitz, New York, NY, Blake A. Biles, Washington, DC, for Plaintiff.

Karen Patricia Seifert, United States Department of Justice, Washington, DC, for Defendants.

MEMORANDUM OPINION

JAMES E. BOASBERG, District Judge.

In November 2011, Plaintiff American Chemistry Council submitted a Freedom of Information Act request to a division of the Department of Health and Human Services. ACC sought records pertaining to a federally funded study that had considered the potential health effects of exposure to formaldehyde. The study's findings had led HHS to elevate formaldehyde's carcinogenic status in its biennial Report on Carcinogens. Unhappy with HHS's response to its FOIA request, Plaintiff then brought this suit alleging that Defendants' search of their records was inadequate and that they improperly refused to request research data from the study's authors. ACC seeks relief under FOIA and the Administrative Procedure Act, as well as a writ of mandamus.

Defendants—HHS and three of its component agencies—now move to dismiss under Federal Rules of Civil Procedure 12(b)(6) and 12(b)(1). Because the only research data sought from the authors is publicly available, the Court will grant Defendants' Motion on that issue. The Court, however, agrees with ACC that it is premature to conclude that Defendants performed an adequate search of their own records. Finally, because FOIA already provides sufficient relief, the Court will dismiss Plaintiff's alternative claims under the APA and for mandamus.

I. BackgroundA. Report on Carcinogens

In 1978, Congress ordered HHS to begin publishing “a biennial report which contains ... a list of all substances ... [that] are known to be carcinogens or may reasonably be anticipated to be carcinogens and ... to which a significant number of persons ... are exposed [and] ... information concerning the nature of such exposure.” 42 U.S.C. § 241(b)(4)(A)-(B); see Community Mental Health Centers Extension Act of 1978, Pub.L. No. 95–622, § 262(10), 92 Stat. 3412, 3435. Pursuant to that congressional mandate, a component entity of HHS has subsequently published twelve “Report[s] on Carcinogens” (RoC). See About the Report on Carcinogens, Nat'l Toxicology Program, http:// ntp. niehs. nih. gov/? objectid= 03 C 9 B 512– ACF 8– C 1 F 3ADBA 53 CAE 848 F 635 (last updated Sept. 7, 2012) (“The 12th RoC, the latest edition, was published on June 10, 2011.”).

Formaldehyde, “a colorless, flammable gas that is used in aqueous solution to manufacture building materials and many household products,” was first listed in the second edition of the RoC. See Compl., ¶¶ 9–10; Nat'l Toxicology Program, Dep't of Health & Human Servs., Report on Carcinogens 195 (12th ed. 2011) (“ 12th RoC ”). For the ensuing thirty years, the Report classified the substance in a lesser carcinogenic category—namely, “reasonably anticipated to be a human carcinogen.” See 12th RoC at 195. The 12th RoC, however, upgraded it to the more severe category of “known to be a human carcinogen.” See id. In doing so, the report cited, inter alia, Luoping Zhang et al., Occupational Exposure to Formaldehyde, Hematoxicity, and Leukemia–Specific Chromosome Changes in Cultured Myeloid Progenitor Cells,

19 Cancer Epidemiology, Biomarkers & Prevention 80 (2010) (Zhang Study). See id. at 195, 197–200. The Zhang Study is a published scientific research article that was funded, at least in part, by federal grants disbursed by Defendants. Compl., ¶¶ 5, 14.B. OMB Circular A–110

The relationship between FOIA and federally funded grantees is governed in part by the Shelby Amendment. This 1999 legislation directed the Office of Management and Budget to amend its Circular A–110—its full title is “Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non–Profit Organizations”“to require Federal awarding agencies to ensure that all data produced under an award will be made available to the public through the procedures established under [FOIA].” Omnibus Consol. & Emergency Supplemental Appropriations Act for the Fiscal Year 1999, Pub. L. No. 105–277, 112 Stat. 2681–495 (1998). OMB, in response, revised Circular A–110 to reflect its current form. It states, in relevant part:

[I]n response to a [FOIA] request for research data relating to published research findings produced under an award that were used by the Federal Government in developing an agency action that has the force and effect of law, the Federal awarding agency shall request, and the recipient shall provide ... the research data so that they can be made available to the public through the procedures established under the FOIA.

OMB Circular A–110 § ––––.36(d)(1) (emphasis added). HHS has since codified Circular A–110 in the Code of Federal Regulations. See45 C.F.R. § 74.36(d)(1)-(2).

C. Plaintiff's FOIA Request

On November 7, 2011, ACC's Assistant General Counsel submitted a FOIA request for “all Records related to [the Zhang Study],” including any records related to the federal grants that provided funding to the study. Compl., Exh. 1 (FOIA Request) at 1. Plaintiff specifically demanded three categories of documents: (1) “Records related to the protocol and methodology for conducting the [Zhang] Study”; (2) “Records related to the information and data obtained regarding the [Zhang] Study subjects”; and (3) “Records related to any analyses, results, ... findings and conclusions” of the Zhang Study. Id. at 1–2. Under item 2, Plaintiff sought:

2. All Records related to the information and data obtained regarding the Study subjects. These include all Records concerning:

a. Original questionnaires administered to Study subjects by trained interviewers requesting such information as occupational history, environmental exposures, medical history and current medications, and past and current tobacco and alcohol use.

b. Spreadsheets or other Records that were developed in order to summarize and/or analyze the information collected as part of the questionnaires administered to each Study subject.

c. Records identifying the specific factory at which each Study subject was employed.

d. Records identifying the specific Chinese or Western medicines used by each Study subject.

e. Records containing the laboratory analytical results from the exposure monitoring conducted with UME diffusion samplers worn by each Study Subject.

f. Data and methods used for estimating 8–hr time weighted average levels for control subjects and exposed subjects.

g. Records that provide the Study subjects' individual clinical chemistry results, to include laboratory standardization, laboratory reference values and interlaboratory comparison statistics.

Id. at 2 (emphasis added).

In a December 1 letter communicating the Agency's “final response” to Plaintiff's FOIA request, HHS attached 108 pages of documents, but refused to forward ACC's request under 2f to the Zhang Study's grantees pursuant to Circular A–110. See Compl., Exh. 3 (Final Response Letter) at 3. The Agency explained:

To the extent that your request under item 2f seeks data produced under [an agency] grant pursuant to the provisions of [Circular A–110], please understand that that the provisions of Revised Circular A110 apply to data:

• First produced under a new or competing continuing grant awarded after April 17, 2000, (the day [HHS] amended 45 C.F.R. Part 74 to implement Revised Circular A–110); and

• Cited publicly and officially by the Federal Government in support of an agency action that has the force and effect of law.

Because the data you have requested does not meet one or both of the above referenced criteria, [the Agency] will not forward your request under item 2f to the grantee for response.

Id.

Plaintiff appealed this final response arguing, inter alia:

In the [Agency's final] Response, [the Agency] contends that the provisions of OMB Circular A–110 apply to data (1) first produced under a new or competing continuing grant awarded after April 17, 2000, and (2) cited publicly and officially by the Federal Government in support of an agency action that has the force and effect of law. [The Agency] further contends that “because the data you have requested does not meet one or both criteria, [the Agency] will not forward your request under item 2f to the grantee for response.” Since the grants at issue were awarded well after April 17, 2000, it appears that NIH is asserting that the Study has not been “cited publicly and officially by the Federal Government in support of an agency action that has the force and effect of law.”

Compl., Exh. 4 (FOIA Appeal Letter) at 6. The remainder of that portion of the appeal argued solely that the Zhang Study had been cited in the 12th RoC and draft EPA regulations, both of which Plaintiff asserted had the force and effect of law. Id. ACC, however, did not address whether Circular A–110 should apply to items other than 2f.

The Agency responded to the appeal approximately one month after Plaintiff had filed the instant lawsuit. See Opp., Exh. 2 (HHS Response to Appeal) at 1. In it, HHS determined that it did not need to request data from the Zhang Study's grantees because neither the RoC nor the draft EPA regulations were final agency actions having the force and effect of law. Id. at 4. It did, however, enclose thirty-two pages of additional records that were retrieved from a component of HHS that had not been previously searched. Id. at 2.

In bringing its suit, Plaintiff alleges that Defendants violated FOIA and Circular A–110 both because their search of their own records was inadequate and because they failed to request data from the Zhang Study's grantees. Plaintiff seeks relief under FOIA (Count I)...

To continue reading

Request your trial
101 cases

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT