Physicians Committee for Responsible Medicine v. U.S. Environmental Protection Agency

451 F. Supp. 2d 223, 2006 U.S. Dist. LEXIS 64329
CourtDistrict Court, District of Columbia
DecidedSeptember 11, 2006
DocketCivil Action 05-1369 (RMU)
StatusPublished
Cited by1 cases

This text of 451 F. Supp. 2d 223 (Physicians Committee for Responsible Medicine v. U.S. Environmental Protection Agency) is published on Counsel Stack Legal Research, covering District Court, District of Columbia primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Physicians Committee for Responsible Medicine v. U.S. Environmental Protection Agency, 451 F. Supp. 2d 223, 2006 U.S. Dist. LEXIS 64329 (D.D.C. 2006).

Opinion

MEMORANDUM OPINION

Granting the Defendants’ Motion to Dismiss

URBINA, District Judge.

I. INTRODUCTION

The plaintiffs, Physicians Committee for Responsible Medicine (“PCRM”), People for the Ethical Treatment of Animals (“PETA”), and three individuals, bring suit against the Environmental Protection Agency (“EPA”) and Administrator Stephen L. Johnson (collectively, “the defendants”), alleging that the defendants’ adoption of a series of test protocols and guidelines violates the Administrative Procedure Act (APA) rulemaking requirements.

Specifically, the plaintiffs challenge the EPA’s decision to deny their petition to repeal the Developmental Neurotoxicity Test Guidelines (“DNT Guidelines”). The DNT Guidelines are non-mandatory testing procedures which pesticide manufacturers may use in supporting an application to the EPA for a pesticide registration. This case is now before the court on the defendants’ motion to dismiss. Because the plaintiffs lack standing, the court grants the defendants’ motion to dismiss.

II. BACKGROUND

A. The Parties

Plaintiff PCRM is a nonprofit organization based in Washington, D.C. Compl. ¶ 9. It is committed to “promoting a safe and healthful diet and to protecting consumers from food and drink that are dangerous or unhealthful.” Id. PCRM has joined forces with PETA, a national nonprofit membership organization committed to “protecting animals from exploitation and suffering, and to promote a safe and healthful diet.” Id. ¶ 12. According to the complaint, each of the three individual plaintiffs, Trulie Ankerberg-Noblis, Robin Hummel, and Jennifer Reilly, are pregnant (and may have additional children in the future), are vegetarians, and “advocate for a safe and healthy diet.” Id. ¶¶ 15, 18, 20. The individual plaintiffs are concerned about the impact that pesticides may have had, and may continue to have, on their fetuses, on the breast milk they will use to feed their infants, and on their young children. Id. ¶¶ 15,18, 20.

Defendant EPA, among other things, is tasked with the regulation and licensing of pesticides. Under the Federal Food, *226 Drug, and Cosmetic Act (“FFDCA”), the EPA is responsible for the regulation of pesticides in food. 21 U.S.C. §§ 301-394. Under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), the EPA is responsible for “imposing] a federal licensing scheme on the sale, distribution, and use of pesticides.” 7 U.S.C. §§ 136— 136y. Both the FFDCA and the FIFRA articulate how the EPA shall carry out these responsibilities.

Prior to any pesticide entering the marketplace, the pesticide manufacturer must obtain registration for that particular pesticide from the EPA. The EPA, in turn, evaluates data submitted by the pesticide manufacturer concerning the candidate pesticide. Defs.’ Mot. at 5. The EPA may carry out this data evaluation in one of two ways. First, the EPA can require that the pesticide chemical residue pass a “tenfold margin of safety” for children and infants. 21 U.S.C. § 346a(b)(2)(C). In other words, the pesticide manufacturer must show that the pesticide is ten times safer than the typical exposure limits for adults. Second, in the agency’s discretion, it may utilize a margin of safety other than the “tenfold margin of safety” only if “on the basis of reliable data, such margin will be safe for infants and children.” Id. Toward this end, the EPA established DNT Guidelines. Under the DNT Guidelines, the EPA considers developmental neurotoxicity data- — data pertaining to the neurological and behavioral effects of exposure to the pesticide. 1 Defs.’ Mot. at 5. “The ultimate goal of DNT testing is to predict with confidence the neurotoxic potential (or lack thereof) of a test chemical in human infants and children by the extrapolation of data from laboratory experiments on animals.” Compl. ¶ 41. Although developmental neurotoxicity data is not among the data required by the EPA to support a pesticide registration, the EPA has created the DNT Guidelines for pesticide manufacturers to use in collecting data on the safety of the pesticide. Defs.’ Mot. at 6, 18. If the chemical manufacturer does not supply the EPA with developmental neurotoxicity data in support of a particular pesticide application, the EPA will apply the statutory default “Tenfold Margin of Safety.” Compl. ¶¶ 4, 68.

B. The Plaintiffs’ Claims

In carrying out its regulatory responsibilities and in determining whether a particular pesticide is safe to enter the marketplace, the EPA must pay particular attention to the health and well-being of children, and must “ensure that there is a reasonable certainly that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue.” 21 U.S.C. § 346a(b)(2)(C). The plaintiffs claim that the DNT testing procedures and protocols set up by the EPA to monitor the margin of “safety” for children and infants are marginally or no safer than the standards for adults and thus violate the FFDCA. Compl. ¶ 3. The FFDCA requires that any alternative to the “Tenfold Margin of Safety” must be based on reliable data, 21 U.S.C. § 346a(b)(2)(C), and the plaintiffs allege that the EPA’s DNT testing procedure “barely qualifies as ‘scientific,’ and is fraught with so many uncertainties and problems that its use to establish ‘reasonable certainty’ is, beyond reasonable dispute, arbitrary, and capricious,” Compl. ¶ 3.

On July 11, 2005, the plaintiffs filed suit in this court seeking reversal of the EPA’s regulatory decisions regarding child expo *227 sure to chemical residue. First, the plaintiffs challenge the defendants’ rejection of the plaintiffs’ petition requesting that the EPA repeal its DNT Guidelines. The plaintiffs claim that the rejection was arbitrary and capricious or otherwise not in accordance with law in violation of the Administrative Procedures Act (“APA”), 5 U.S.C. § 706(2)(a). Compl. ¶¶ 78-79. Second, the plaintiffs allege that the defendants violated the APA’s procedural requirements by issuing final rules without first providing public notice or an opportunity for public comment. 2 Id. ¶¶ 23, 80-82.

C. Procedural Background

The legal debate concerning the EPA’s use of DNT Guidelines is not a new one. Plaintiffs PCRM and PETA previously brought suit challenging the EPA’s DNT Guidelines in the United States Court of Appeals for the District of Columbia Circuit. 3 Helstosky v. EPA,

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451 F. Supp. 2d 223, 2006 U.S. Dist. LEXIS 64329, Counsel Stack Legal Research, https://law.counselstack.com/opinion/physicians-committee-for-responsible-medicine-v-us-environmental-dcd-2006.