Natural Res. Def. Council v. United States Envtl. Prot. Agency

• Decision Date: 16 September 2011
• Docket Number: Docket No. 08–3771–ag.
• Citation: 73 ERC 1257,658 F.3d 200
• Parties: NATURAL RESOURCES DEFENSE COUNCIL, Petitioner,v.UNITED STATES ENVIRONMENTAL PROTECTION AGENCY, Respondent.
• Court: U.S. Court of Appeals — Second Circuit

658 F.3d 200

73 ERC 1257

NATURAL RESOURCES DEFENSE COUNCIL, Petitioner,

v.UNITED STATES ENVIRONMENTAL PROTECTION AGENCY, Respondent.

Docket No. 08–3771–ag.

United States Court of Appeals, Second Circuit.

Argued: Feb. 14, 2011.Decided: Sept. 16, 2011.

Aaron Colangelo, Natural Resources Defense Council, Washington, D.C., for Petitioner.Kent E. Hanson, U.S. Department of Justice, Environment & Natural Resources Division (Ignacia S. Moreno, Assistant Attorney General, Jonathan J. Fleuchaus, U.S. Environmental Protection Agency, Office of General Counsel), Washington, D.C., for Respondent.Before: POOLER, WESLEY, and CHIN, Circuit Judges.POOLER, Circuit Judge:

The pesticide dichlorovinyl dimethyl phosphate (“DDVP” or “dichlorvos”) is used to kill many types of insects. Depending on the level of one's exposure to dichlorvos, the pesticide also may disrupt proper functioning of the human nervous system. To determine safe levels of exposure to dichlorvos for certain exposure scenarios, the Environmental Protection Agency (“EPA”) relied heavily on a single study in which six people were paid to ingest a dose of the pesticide every day for three weeks. After the study detected an adverse effect, EPA used the study to attempt to estimate, to a reasonable certainty, an aggregate level of exposure to dichlorvos at which no harm would result. EPA then set tolerances regarding the maximum level of dichlorvos residue on food products. EPA also registered numerous dichlorvos products for sale and distribution in the United States.

In June 2006, NRDC petitioned EPA to revoke all tolerances and cancel all registrations for dichlorvos. EPA denied the petition and in response NRDC filed objections and requests for a public evidentiary hearing. EPA denied those requests in a July 23, 2008 final order. NRDC now seeks review of that EPA order, arguing in part that EPA failed to explain why, when assessing the safety of dichlorvos for certain exposure scenarios, EPA did not apply an additional tenfold children's safety factor, to account for potential pre- and post-natal toxicity and completeness of data with respect to exposure and toxicity to infants and children. Because such an explanation is required under the Food Quality Protection Act of 1996 (“FQPA”), see 21 U.S.C. § 346a(b)(2)(C)(ii), we grant NRDC's petition for review in part, vacate EPA's June 23, 2008 order in part, and remand for further proceedings.

NRDC also appeals EPA's decision not to apply the tenfold children's safety factor for certain risk assessments in which EPA did not rely on the above-mentioned human study. In this regard, NRDC argues only that EPA cannot reduce or waive the tenfold children's safety factor unless and until it completes the FQPA-mandated endocrine disruptor screening program. We reject this argument. FQPA allows EPA to reduce or waive the tenfold margin of safety if “reliable data” indicate that a lower margin of safety will be safe for infants and children. FQPA does not require the “reliable data” to come from the endocrine disruptor screening program. Accordingly, we deny in part NRDC's petition for review.

Lastly, having vacated the portions of EPA's June 23, 2008 order assessing the risk of dichlorvos based on the above-mentioned human study, we need not decide whether NRDC is entitled to a public evidentiary hearing regarding that study's alleged statistical invalidity and failure to obtain informed consent.

I. The Statutory Authority for the EPA's Regulation of Pesticides

A.

EPA oversees a comprehensive scheme of pesticide regulation under the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. §§ 301–94, and the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), 7 U.S.C. §§ 136–36y.

FDCA regulates pesticide residues in the food supply and requires EPA to establish tolerance levels (or exemptions) for the maximum permissible level of pesticide residue on food products. 21 U.S.C. § 346a(a)-(c). “Before any agricultural commodity containing pesticide residue can be sold or distributed, a tolerance (or exemption) meeting certain safety standards must be promulgated by the EPA.” Natural Res. Def. Council v. Johnson, 461 F.3d 164, 167 (2d Cir.2006). Under FDCA, a safe tolerance for a pesticide is determined by considering “aggregate exposure” to the pesticide, including “all anticipated dietary exposures.” 21 U.S.C. § 346a(b)(2)(A)(ii).

FIFRA has a slightly different focus, but is linked with FDCA in an important regard. FIFRA establishes a pesticide registration system and requires EPA to set the conditions under which pesticides may be sold or distributed in the United States. 7 U.S.C. § 136a(c)(5); see also id. § 136q (regulating labeling, packaging, composition, and disposal). In determining whether to register a pesticide under FIFRA, EPA must consider whether the pesticide is safe under FDCA. Id. § 136a(c)(5)(C). In particular, EPA may not register or reregister a pesticide if it determines that the pesticide would cause “unreasonable adverse effects on the environment,” id., which includes an “unreasonable risk to man” or a “human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with the standard under [21 U.S.C. § 346a],” id. § 136(bb). In addition, if EPA determines that a registered pesticide causes “unreasonable adverse effects on the environment,” it may cancel the registration. Id. § 136d(b)(1).

B.

In 1988, Congress asked the National Academy of Sciences (“NAS”) to appoint a committee to study the vulnerability of infants and children to pesticide residues. Five years later, the NAS's National Research Council released a report on the issue, concluding that “[t]raditional approaches to toxicological risk assessment may not always adequately protect infants and children” and recommending various reforms. National Research Council, Pesticides in the Diets of Infants and Children at 360 (1993), available at http:// www. nap. edu/ catalog. php? record_ id= 2126 (hereinafter, “Nat'l Research Council, Pesticides Report ”). See also id. at 359–63.

In 1996, in response to the National Research Council report, and aiming to better coordinate the safety standards in FIFRA and FDCA, Congress passed the Food Quality Protection Act (“FQPA”). Pub.L. No. 104–170, 110 Stat. 1489 (1996). Three changes are most relevant here. First, FQPA established a new safety standard for pesticide tolerances. Under FQPA, a pesticide tolerance is “safe” when “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). In making this determination, Congress required EPA to consider, among other things, “the validity, completeness, and reliability of the available data from studies,” the anticipated and actual residue levels of the pesticide in or on foods, “the dietary consumption patterns of consumers,” “the percent of food actually treated with the pesticide,” and international standards. See id. § 346a(b)(2)(D)-(F), (b)(4). Further, Congress required EPA to consider

safety factors which in the opinion of experts qualified by scientific training and experience to evaluate the safety of food additives are generally recognized as appropriate for the use of animal experimentation data.

Id. at § 346a(b)(2)(D)(ix). In this regard, the House Report noted that it “expect[ed], based on discussions with [EPA],” that EPA would apply “a 100–fold safety factor ... to the scientifically determined ‘no observable effect’ level when data are extrapolated from animal studies.” H.R.Rep. No. 104–669, at 32, 1996 U.S.C.C.A.N. 1268, 1280 (1996) (limiting this requirement to threshold effects, in which EPA “is able to identify a level at which the pesticide chemical residue will not cause or contribute to any known or anticipated harm to human health”).

Second, Congress required EPA to assess the risk of pesticide residue to infants and children when “establishing, modifying, leaving in effect, or revoking a tolerance or exemption.” 21 U.S.C. § 346a(b)(2)(C). In assessing the risk, Congress required EPA to consider available information about:

[I] consumption patterns among infants and children that are likely to result in disproportionately high consumption of foods containing or bearing such residue among infants and children in comparison to the general population; ...

[II] the special susceptibility of infants and children to the pesticide chemical residues, including neurological differences between infants and children and adults, and effects of in utero exposure to pesticide chemicals; and ...

[III] the cumulative effects on infants and children of such residues and other substances that have a common mechanism of toxicity.

21 U.S.C. § 346a(b)(2)(C)(i).

For each pesticide tolerance, Congress required EPA to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue.” Id. § 346a(b)(2)(C)(ii)(I). To make this determination, Congress required EPA to use “an additional 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.” Id. § 346a(b)(2)(C)(ii) (limiting this requirement to threshold effects). 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).

Lastly, given FQPA's substantial changes to the method of determining pesticide safety, “FQPA required that the EPA reassess the safety of all then-existing tolerances.” Johnson, 461 F.3d at 168. For this review, Congress required EPA to determine whether each tolerance is “safe” or exempt from the...