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PHYSICIANS COMMITTEE FOR RESPONSIBLE MEDICINE v. HORINKO

August 25, 2003

PHYSICIANS COMMITTEE FOR RESPONSIBLE MEDICINE, ET AL. PLAINTIFF(S) -V- MARIANNE LAMONT HORINKO, ACTING ADMINISTRATOR, UNITED STATES ENVIRONMENTAL PROTECTION AGENCY DEFENDANT(S)


The opinion of the court was delivered by: Laura Taylor Swain, District Judge [ Page 2]

OPINION AND ORDER

Before the Court are cross-motions for summary judgment pursuant to Rule 56 of the Federal Rules of Civil Procedure. Plaintiffs Physicians Committee for Responsible Medicine ("PCRM"), People for the Ethical Treatment of Animals ("PETA"), American Anti-Vivisection Society ("AAVS"), Alternatives Research & Development Foundation ("ARDF"), Rosa Naparstek, Scott Mishler and John Gentry (collectively, "Plaintiffs") seek judgment as a matter of law on their claims arising from the involvement of defendant United States Environmental Protection Agency ("EPA" or "Defendant") in a voluntary testing program designed to generate toxicity data on some 2,800 high production volume ("HPV") chemicals. In their two-count complaint, Plaintiffs allege that Defendant violated the Toxic Substances Control Act ("TSCA"), 15 U.S.C.A. §§ 2601-2629, by implementing a voluntary testing program ("HPV Challenge Program") rather than promulgating a formal test rule via notice-and-comment rulemaking in accordance with the requirements of Section 4 of TSCA, 15 § U.S.C.A. 2603. Plaintiffs also allege that Defendant violated Sections 3, 5, 9 and 10 of the Federal Advisory Committee Act ("FACA"), 5 U.S.C.A. App. 2, by meeting with representatives of the Chemical Manufacturers Association ("CMA") and the Environmental Defense Fund ("EDF") as part of the process of developing and implementing the HPV Challenge Program. Plaintiffs argue that such meetings amounted to the establishment and/or utilization of an "advisory committee" and that, as a result, Defendant violated FACA by not complying with the statute's public participation and accountability requirements.

Plaintiffs seek an order enjoining Defendant from continuing to implement the HPV Challenge Program, a declaratory judgment that Defendant violated Section 4 of TSCA and Sections 3, 5, 9 and 10 of FACA, and, in the event the Court is not inclined on the evidence [ Page 3]

presented to grant Plaintiffs' motion with respect to their FACA claim, an order compelling Defendant to produce to Plaintiffs certain documents and information related to Plaintiffs' FACA claim that were not previously provided.

Defendant opposes Plaintiffs' motion and has filed a cross-motion for summary judgment, arguing that the Court lacks subject matter jurisdiction of Plaintiffs' claims under TSCA because the statute's citizen suit provision only authorizes civil actions brought to compel the EPA Administrator to perform a duty which is not discretionary. Defendant argues that it was not required to promulgate formal test rules because it did not make the findings necessary to trigger TSCA's mandatory rulemaking provisions. Defendant also contends that it is entitled to summary judgment on the merits of Plaintiffs' FACA claim because it did not establish or utilize an advisory committee within the meaning of FACA and, therefore, was not under any duty to comply with FACA's provisions. Finally, Defendant argues that Plaintiffs have not satisfied their burden for obtaining further discovery pursuant to Fed. R. Civ. P. 56(f).

The Court has considered thoroughly all of the parties' submissions and arguments pertaining to the motions. For the following reasons, Plaintiffs' motion for summary judgment and its request for additional discovery are denied, while Defendant's motion for summary judgment is granted in part and denied in part.

BACKGROUND

The following facts are undisputed except as specified otherwise. The United States imports or produces approximately 2,800-3,000 non-polymeric, organic chemical substances and mixtures in amounts equal to or greater than 1 million pounds per year. These [ Page 4]

substances and mixtures are known as high production volume ("HPV") chemicals. (Pl.'s Local Rule 56.1 Statement ("PR56.1") ¶ 1; Declaration of Charles M. Auer, May 2, 2003 ("Auer Decl.") ¶ 39.)

In the late 1980's, the Organization for Economic Cooperation and Development ("OECD"), an international organization of which the United States is a member, implemented the Screening Information Data Set ("SIDS") program, which led to the development of an internationally recognized set of screening tests designed to aid in the gathering of toxicity data on HPV chemicals. Various chemical companies, including several American companies, have engaged in SIDS testing pursuant to the OECD HPV Program. (Auer Decl. ¶¶ 23-25.)

Despite this initiative, however, the environmental group Environmental Defense Fund asserted in a July 1997 report entitled Toxic Ignorance that existing knowledge of the potentially harmful effects of a sizeable percentage of the HPV chemicals being released into the environment was insufficient. (EDF Report, Toxic Ignorance: The Continuing Absence of Basic Health Testing for Top-Selling Chemicals in the United States (July 1997)). Based on a study of a sample of HPV chemicals, the report concluded that SIDS data relating to human health hazards were available for only 29% of domestic HPV chemicals. Id.

In the aftermath of the report's release, EPA conducted its own analyses and concluded that no publicly available data existed for about 43% of HPV chemicals, while only minimal data existed for most of the remaining chemicals. (Def's Local Rule 56.1 Statement ("DR56.1") ¶ 4). Plaintiffs dispute the accuracy of EPA's findings.

Defendant asserts that, at the time EDF issued its July 1997 report, EDF also issued a formal challenge to 100 chemical companies, asking them to develop health data by the [ Page 5]

year 2000 on about 3,000 chemicals they manufacture. (Declaration of Larry W. Rampy, April 29, 2003 ("Rampy Decl.") ¶ 5). According to Defendant, EDF and CMA began discussions relating to EDF's challenge during the summer of 1997. Defendant asserts that EDF and CMA kept Defendant informed about the discussions and invited Defendant to at least one of their meetings. (Id. ¶¶ 7-11). Defendant claims that, as a result of the discussions between EDF and CMA, CMA announced in April 1998 that both the pace of testing as well as the quantity of chemicals to be tested by American companies through the SIDS program would increase sevenfold. (Id. ¶ 10). According to Plaintiffs, it was EPA that requested that CMA increase the pace of testing. (Letter from CMA to People for the Ethical Treatment of Animals, January 8, 1999.)

On Earth Day, April 21, 1998, Vice President Al Gore announced the national "Chemical Right-to-Know" initiative, which is an effort to provide the public with information about the risks associated with those chemicals that are most pervasive in the environment. The program was designed to "accelerate the development and dissemination of public health and environmental testing data," and included a challenge to manufacturers to test all of the 3,000 or so HPV chemicals within a three-year period. (EPA, Chemical Right-to-Know Program Frequently Asked Questions; Rampy Decl. ¶ 11.)

According to Defendant, after the launch of the Chemical Right-to-Know initiative, CMA and EDF continued their dialogue regarding the need to generate data on HPV chemicals. Defendant asserts that, in June of 1998, CMA and EDF informed Defendant that they had reached broad agreement on a plan to accelerate the generation of publicly available data on HPV chemicals. (Rampy Decl. ¶ 13; Declaration of David Roe, May 1, 2003 ("Roe Decl.") ¶ 12). [ Page 6]

Defendant claims that it informed the organizations that it would be willing to consider their joint proposal, but asserts that it neither directed EDF and CMA to meet nor exerted any influence or control over who attended their meetings. (DR56.1 ¶ 11). According to Defendant, CMA and EDF worked on a framework for an agreement during the summer of 1998 and communicated the framework to EPA in September 1998. Id. On October 9, 1998, EPA, in cooperation with EDF and CMA, announced the establishment of the HPV Challenge Program, a voluntary toxicity data collection effort. The program is an attempt by EPA to challenge the chemical industry to voluntarily sponsor testing of approximately 2,800 HPV chemical substances or mixtures. (Id. ¶¶ 14-15). In conjunction with its formal announcement of the program, EPA sent a letter to approximately 900 chemical companies inviting them to participate in the endeavor. (PR56.1 ¶ 17). Under the program, sponsors are asked to submit to EPA a commitment letter, a "robust summary" of existing data on the particular chemical, and a test plan detailing the manner in which the sponsor expects to fill the gaps, if there are any, in the already existing data (in some cases by performing tests using SIDS protocols). (DR56.1 ¶ 16; EPA, Data Collection and Development on High Production Volume (HPV) Chemicals, 65 Fed. Reg. 81,686, 81,692 (Dec. 26, 2000)). Chemicals may be sponsored by individual companies as well as by consortia and, under certain circumstances, chemicals and mixtures can be grouped into categories for testing purposes. Id. at 81,693-94.

EPA did not issue any public notice pertaining to the development of the HPV Program between the time the Chemical Right-to-Know initiative was announced on April 21, 1998, and the time the HPV Challenge Program was announced on October 9, 1998. (PR56.1 ¶ 9). On May 5, 1999, EPA published its first and only notice announcing public meetings [ Page 7]

relating to the implementation of the HPV Program. (PR56.1 ¶ 22; High Production Volume Chemical Initiative; Periodic Update Meetings, 64 Fed. Reg. 24,151 (May 5, 1999)). On December 26, 2000, EPA published a notice in the Federal Register detailing the background, purpose, and structure of the HPV Program. The notice provided information on a variety of topics pertaining to the program, including how particular chemicals were chosen for inclusion, what types of information were being collected, the role being played by existing data, and how animal welfare issues were being handled.

The December 26, 2000 notice also explained that the two "commitment" phases of the initiative, during which companies signed on to sponsor particular chemicals, had already been completed, with the first phase having ended on March 15, 1999, and the second phase having ended on December 1, 1999. During the two phases, commitments were garnered from 469 companies to sponsor a total of 2,155 chemicals. (65 Fed. Reg. 81693-94). As of May 5, 2003, approximately 2,165 chemical substances and mixtures had been sponsored in connection with the HPV Challenge Program. (Auer Decl. ¶ 39.)

The notice also indicated that there were two phases of the HPV Challenge Program: the "voluntary phase," which is described above, and a "regulatory" phase, during which proposed test rules would be promulgated pursuant to Section 4 of TSCA for certain of the HPV chemicals that companies did not sponsor voluntarily. (PR56.1 ¶ 24; 65 Fed. Reg. 81,658, 81,686.)

In the December 26, 2000 notice, EPA published a proposed test rule requiring chemical companies to conduct SIDS tests on 37 out of the approximately 600 HPV chemicals not sponsored by companies voluntarily. (PR56.1 ¶ 25; 65 Fed. Reg. 81,658). After formally announcing the HPV Challenge Program in October 1998, EPA [ Page 8]

conducted a public workshop and held meetings with representatives from a variety of outside groups, including PCRM and PETA, on multiple occasions. (Auer Decl. ¶¶ 42-46). Plaintiffs PCRM and PETA have been aware of the HPV Challenge Program since November 1998. During their communications with Defendant, representatives from PCRM and PETA expressed concern over the amount of animal testing that would occur as a result of the HPV Challenge Program. (Complaint ¶ 9). Plaintiffs lobbied for limits on the amount of animal testing that would occur, requesting that EPA: 1) reduce the number of chemicals included in the program on the grounds that already-existing SIDS data were sufficient or further testing was otherwise unnecessary, 2) change the program so that data would be generated by means other than animal testing, and 3) rely solely on human exposure and use data. (Id. ¶ 8.)

Defendant contends that it made changes to the HPV Challenge Program to address Plaintiffs' concerns and minimize the amount of animal testing performed under the program. On October 14, 1999, EPA sent a letter to companies participating in the program delineating a series of principles that were designed to minimize the amount of animal testing used in the program. Companies were urged to test chemicals in groups where appropriate to reduce the overall number of tests required, to defer all testing other than group testing until November 2001, to maximize use of existing data, and to exercise good judgment regarding when certain types of tests were unnecessary. (DR56.1 ¶¶ 21-22). Plaintiffs dispute whether the HPV Challenge Program was changed at all to minimize the amount of animal testing performed and, although Plaintiffs concede that the above-referenced letter was sent and that the principles described above were included, they dispute whether the principles were consistently adhered to by either EPA or the companies participating in the program. (Pl's Response to DR56.1 ¶¶ 21-22). [ Page 9]

Plaintiffs contend that EPA, CMA and EDF underestimated the amount of data on HPV chemicals that was publicly available prior to the establishment of the HPV Challenge Program. Plaintiff PCRM released a report on August 1, 2001, finding that toxicity data that were already present in publicly available databases overlooked by EDF and EPA were sufficient to make basic assessments of the risks associated with most HPV chemicals. (PR56.1 ¶ 26.) Plaintiffs also point to an April 1998 EPA report admitting that its search for all publicly available data was not comprehensive due to limited resources, as well as a June 17, 1999 statement by the EDF before the House Committee on Science, Subcommittee on Energy and Environment, acknowledging that it was likely that some additional unconsidered relevant information for assessing toxicity was available. (Id. ¶¶ 28-29). Defendant asserts that the reason that sponsors participating in the HPV Challenge Program are asked to conduct a review of all relevant existing data before performing testing is to address this concern, i.e., that some available data have not yet been uncovered. (Def's Response to PR56.1 ¶ 27.) Despite the involvement of EDF and CMA in the development of the HPV Challenge Program, EPA did not create any "advisory committee" under FACA in connection with the initiative. EPA also did not file a charter or make findings either that meetings with groups such as EDF and CMA were in the public interest or that the composition of attendees at the meetings was fairly balanced and did not include members with inappropriate special interests. EPA neither made its meetings with EDF and CMA open to the public nor published notices in the Federal Register about meetings relating to the HPV Program. EPA also did not make available for public inspection any records, documents, or transcripts from HPV Challenge [ Page 10]

Program-related meetings with EDF and CMA until after the commencement of this lawsuit. (PR56.1 ¶¶ 10-14; Def's Response to PR56.1 ¶¶ 10-14.) On July 16, 2002, Plaintiff PCRM requested that EPA provide it with copies of "any and all documents generated as a result of the meeting(s) between the EPA, the Environmental Defense Fund (now Environmental Defense), and the Chemical Manufacturers Association (now the American Chemistry Council) from April to October 1998 which resulted in the development of the HPV Challenge Program." (Letter Request For Discovery from PCRM to EPA, July 16, 2002; PR56.1 ¶ 34). No documents concerning the development of the HPV Challenge Program were produced to Plaintiff or otherwise made publicly available by EPA ...


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