Opinion ID: 3068682
Heading Depth: 3
Heading Rank: 1

Heading: The Diesel Exhaust in Miners Study

Text: Between 1992 and 1995, NIOSH and NCI developed a draft protocol for the study. In 1996, HHS decided to use a particular advisory committee, the NIOSH’s Board of Scientific Counselors (“BSC”), to provide peer review for the draft protocol. In January, April and July 1997, BSC held public meetings to 1 NIOSH is a component of HHS. 29 U.S.C. § 671(a). NIOSH conducts scientific research related to occupational safety and health. Id. §§ 669(a)(1). NIOSH’s research is used, inter alia, to generate recommendations regarding permissible exposure levels for potentially harmful substances. Id. §§ 669(a)(3), 671(d). Congress has recognized a particular role for NIOSH in mine-related research. Federal Mine Safety and Health Act of 1977, 30 U.S.C. § 801. Congress directed NIOSH to improve and expand research programs to prevent occupational diseases in the mining industry. Id. U.S.C. §§ 801(g), 951(a)(9); see also 29 U.S.C. § 671. Congress declared that “there is an urgent need to provide more effective means and measures for improving the working conditions and practices in the Nation's coal or other mines in order to prevent death and serious physical harm, and in order to prevent occupational diseases originating in such mines.” 30 U.S.C. § 801(c). 2 NCI is another component of HHS. See 42 U.S.C. §§ 281(a), (b)(1); id. § 202. NCI conducts and supports research, information dissemination, and other activities related to “the cause, diagnosis, prevention, and treatment of cancer.” Id. § 285. NCI is also authorized to coordinate its research activities with other public and private entities, such as NIOSH, that perform similar work. See id. § 284(c)(1). 3 MARG represents a majority of the mine operators with mines in the study. Current MARG company members include Cargill, Inc., Detroit Salt, Mossaic Potash (formerly IMC), Morton Salt, General Chemical (now Tata Chemicals, US), FMC Wyoming, and Navistar and Lonny Badeaux who is a plaintiff in his own personal capacity, as a former miner and subject of the study. 2 Case: 11-30812 Document: 00511866647 Page: 3 Date Filed: 05/24/2012 No. 11-30812 review the draft protocol, for which BSC provided notice and allowed for public comment. Plaintiffs offered their comments at the meeting. After the meetings, BSC voted to approve the protocol for the study. Then in 1999, however, Plaintiffs sued, alleging that HHS had violated the Federal Advisory Committee Act (“FACA”) by using BSC to review the draft protocol. Pursuant to FACA, the government must file the charter for an advisory committee (such as BSC) with a certain congressional standing committee, depending on the federal agency that the advisory committee advises. 5 U.S.C. Appx. § 2. HHS had mistakenly filed the charter for BSC with the House Committee on Commerce, rather than the House Committee on Education and the Workforce (“the House Committee”). On appeal, this court held that HHS had indeed made a mistake by filing BSC’s charter with the wrong congressional committee. Cargill, Inc. v. United States, 173 F.3d 323, 334 (5th Cir. 1999). Although inadvertent, HHS’s mistake required correction. To ensure proper congressional oversight of BSC, and to ensure that BSC’s review of the draft protocol was valid, the appropriate congressional committee with the requisite expertise needed to be involved. This court further held that Plaintiffs had standing to compel HHS to refile the charter because the validity of the study protocol affected Plaintiffs’ interests. Id. at 342. The study findings would form the basis for new administrative regulations. An invalid study protocol would generate an invalid study, which could lead to unnecessarily restrictive regulations on Plaintiffs. This court ultimately instructed the district court to fashion an injunction that promoted FACA’s goals of ensuring public accountability and of reducing economic waste. Id. On remand on March 13, 2000, the district court issued an injunctive order to remedy this FACA violation (“2000 Order”), which required HHS to provide study drafts and requested study data to the House Committee, and gave the 3 Case: 11-30812 Document: 00511866647 Page: 4 Date Filed: 05/24/2012 No. 11-30812 House Committee veto power over the study. HHS appealed the order as overly broad, and this court agreed with HHS, instructing the district court to enter a narrower order, stating that there was “little reason for future injunctive relief” beyond refiling the charter with the correct House committee. Akzo-Nobel, Inc. v. United States, 2001 WL 34772206, at – (5th Cir. 2001). “[A]n order requiring [House Committee] approval before the study can be released is not appropriate for HHS’s inadvertent mistake in filing the [BSC’s] charter with the wrong House committee.” Id. at . HHS did not hide from Congressional oversight. It tried to make itself accountable to the public. It unknowingly filed BSC's charter with the wrong House committee and filed it with the correct Senate committee. Plaintiffs and other interested parties had actual notice that the BSC was reviewing the study protocol and were informed of and invited to every meeting of the BSC panel. Id. This court noted concern “that the [House] Committee should have sufficient time to examine the misfiled study data” and become familiar on the validity of the study protocol and BSC’s corresponding advice. Id. at . Accordingly, we instructed the district court to “revise its order so that HHS will be barred from publicly releasing any of the information it sends to the [House] Committee until 90 days after its submission.” Id. On remand again in 2001, the district court issued a new two-part injunctive order (“2001 Order”).4 In the first part of the order, the district court required HHS to submit BSC work product to the House Committee and to Plaintiffs. The last line of the first part states: “Defendants shall provide Plaintiffs with copies of all documents submitted to the Committee in compliance with this Order.” In the second part of the order, the district court required HHS to submit to the House Committee (i) study data requested by the 4