Northwest Coalition for Alternatives to Pesticides v. United States Environmental Protection Agency

544 F.3d 1043, 38 Envtl. L. Rep. (Envtl. Law Inst.) 20246, 67 ERC (BNA) 1737, 2008 U.S. App. LEXIS 20065
CourtCourt of Appeals for the Ninth Circuit
DecidedSeptember 19, 2008
Docket05-75255, 05-76807
StatusPublished
Cited by24 cases

This text of 544 F.3d 1043 (Northwest Coalition for Alternatives to Pesticides v. United States Environmental Protection Agency) is published on Counsel Stack Legal Research, covering Court of Appeals for the Ninth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Northwest Coalition for Alternatives to Pesticides v. United States Environmental Protection Agency, 544 F.3d 1043, 38 Envtl. L. Rep. (Envtl. Law Inst.) 20246, 67 ERC (BNA) 1737, 2008 U.S. App. LEXIS 20065 (9th Cir. 2008).

Opinions

Opinion by Judge PREGERSON; Partial Concurrence and Partial Dissent by Judge IKUTA.

PREGERSON, Circuit Judge:

Petitioners are two environmental groups challenging the Environmental Protection Agency’s (“EPA”) establishment of tolerances for seven pesticides used mostly on fruit and vegetable crops. We grant the petition in part, deny it in part, and remand to the EPA.

BACKGROUND

I.

The EPA regulates pesticides under two statutes: the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), 7 U.S.C. § 136-136y, and the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 346a.

Under FIFRA, pesticides sold in the United States must be registered by the EPA. 7 U.S.C. § 136a. The EPA may not register a pesticide unless the pesticide will perform its intended function without causing “any unreasonable adverse effects on the environment.” 7 U.S.C. § 136a(e)(5)(C).

The FDCA authorizes the EPA to set “tolerances” for pesticide residues in food. [1046]*104621 U.S.C. § 346a(b). “A tolerance is the maximum allowable amount of pesticide that may remain in or on a commodity.” Nader v. EPA, 859 F.2d 747, 748 (9th Cir.1988). The EPA may “establish or leave in effect a tolerance for a pesticide chemical residue in or on a food only if [the EPA] determines that the tolerance is safe.” 21 U.S.C. § 346a(b)(2)(A)(i). The term “safe” is defined to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” 21 U.S.C. § 346a(b)(2)(A)(ii). Any tolerance that is not “safe” must be modified or revoked. 21 U.S.C. § 346a(b)(2)(A)(i).

Tolerances are established by rulemak-ing. 21 U.S.C. § 346a(d). Pesticide manufacturers initiate the rulemaking process by petitioning the EPA to set a tolerance. 21 U.S.C. § 346a(d)(l). The EPA publishes notices of these petitions in the Federal Register. 21 U.S.C. § 346a(d)(3). After reviewing a petition and any comments received on it, the EPA may issue: (1) a final rule establishing a tolerance, (2) a proposed rule, or (3) an order denying the petition. 21 U.S.C. § 346a(d)(4).

Once the EPA takes final action on a petition, any affected party has sixty days to file objections with the EPA and to seek an evidentiary hearing on those objections. 21 U.S.C. § 346a(g)(2). The EPA’s final order in response to those objections is subject to judicial review. 21 U.S.C. § 346a(h)(l).

II.

In 1996, Congress amended the FDCA by enacting the Food Quality Protection Act (“FQPA”), Pub.L. No. 104-170, 110 Stat. 1489. One of the key provisions of the FQPA requires the EPA to give special consideration to risks posed to infants and children when establishing pesticide tolerances. Specifically, the FQPA directs the EPA to use “an additional1 tenfold margin of safety ... to take into account potential pre-and post-natal toxicity and completeness of the data with respect to exposure and toxicity to infants and children.” 21 U.S.C. § 346a(b)(2)(C). This tenfold (or “10x”) child safety factor is presumptively applied to all tolerances. Thus, in making tolerance decisions, the EPA must assume that the risk to children from the use of a particular pesticide on food is ten times greater than for adults. The EPA may “use a different margin of safety for the pesticide chemical residue only if, on the basis of reliable data, such margin will be safe for infants and children.” Id. (emphasis added).

Unfortunately, the FQPA does not define “reliable data.” The dispute before us turns on the definition of this term.

Between December 2001 and April 2002, the EPA published seven regulations establishing tolerances for the pesticides ace-tamiprid, fenhexamid, halosulfuron-methyl, isoxadifen-ethyl, mepiquat, pymetrozine, and zetacypermethrin used on many foods, including fruits, vegetables, nuts, cereal grains, milk, and eggs.2 Each regulation [1047]*1047was promulgated in response to an industry petition to establish tolerances.

The EPA did not apply the presumptive lOx child safety factor to any of these seven pesticides. The EPA reduced the lOx child safety factor to 3x for four of the pesticides (acetamiprid, fenhexamid, isoxa-difen-ethyl, and pymetrozine). For the remaining three pesticides (halosulfuron, me-piquat, and zeta-cypermethrin), the EPA did not apply a child safety factor at all.

In 2002, Natural Resources Defense Council, Inc. (“NRDC”) filed objections to each of the tolerances based on the EPA’s decision to reduce or remove the child safety factor.3 NRDC argued that the EPA did not have “reliable data” allowing it to deviate from the child safety factor.

On August 10, 2005, the EPA issued its final order rejecting NRDC’s objections. See Order Denying Objections to Issu-ances of Tolerances, 70 Fed.Reg. 46,706 (Aug. 10, 2005) (hereinafter “Final Order”). The Final Order upheld the 3x child safety factor for acetamiprid, fenhex-amid, isoxadifenethyl, and pymetrozine, and a lx child safety factor (i.e., no safety factor) for halosulfuron, mepiquat, and ze-taeypermethrin. Id. at 46,711-13, 46,736.

NRDC and the Northwest Coalition for Alternatives to Pesticides (“NCAP”) each petitioned for review of the Final Order.

JURISDICTION

We have jurisdiction under the FDCA, which provides that “any person who will be adversely affected” by an EPA order denying tolerance objections may file a petition for review in the Court of Appeals within 60 days of the EPA’s order. 21 U.S.C. § 346a(h)(l).

NRDC filed administrative objections to the tolerances in 2002. The EPA published its Final Order denying those objections on August 10, 2005.

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544 F.3d 1043, 38 Envtl. L. Rep. (Envtl. Law Inst.) 20246, 67 ERC (BNA) 1737, 2008 U.S. App. LEXIS 20065, Counsel Stack Legal Research, https://law.counselstack.com/opinion/northwest-coalition-for-alternatives-to-pesticides-v-united-states-ca9-2008.