Opinion ID: 2470339
Heading Depth: 1
Heading Rank: 1

Heading: The Statutory Authority for the EPA's Regulation of Pesticides

Text: 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).
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 tolerance requirement. 21 U.S.C. § 346a(q)(1). If a tolerance is neither safe nor exempt, EPA must modify or revoke the tolerance. Id. Because this tolerance reassessment program runs concurrent to FIFRA's reevaluation of pesticide registrations, see 7 U.S.C. § 136a-1, and because both programs rely on the same underlying risk assessments for pesticides, see id. §§ 136(bb), 136a(c)(5)(C), EPA frequently has used Interim Reregistration Eligibility Decisions (IREDs) to announce decisions on both tolerance reassessment and pesticide reregistration. Johnson, 461 F.3d at 169.
To challenge an existing tolerance, [a]ny person may file with EPA a petition proposing that EPA modify[] or revok[e] a tolerance for a pesticide chemical residue in or on a food. 21 U.S.C. § 346a(d)(1)(A). EPA requires such a petitioner to furnish reasonable grounds for the action sought, such as an assertion of facts (supported by data if available) showing... that experience with the application of the tolerance or exemption from tolerance may justify its modification or revocation. 40 C.F.R. § 180.32(b). If EPA denies the petition, it must issue a regulation or order explaining its reasons. 21 U.S.C. § 346a(d)(4)(A). Within sixty days after such regulation or order is issued, any personnot just the petitionermay file objections thereto with EPA. Id. § 346a(g)(2)(A). The objections must specify[] with particularity the provisions of the regulation or order deemed objectionable and stat[e] reasonable grounds therefor. Id. In addition, a party's objections may include a request for a public evidentiary hearing upon the objection. Id. § 346a(g)(2)(B). The party is entitled to a public evidentiary hearing if and to the extent [EPA] determines that such a public hearing is necessary to receive factual evidence relevant to material issues of fact raised by the objections. Id. EPA's implementing regulations provide that a request for a hearing will be granted when the requesting party shows that: (1) There is a genuine and substantial issue of fact for resolution at a hearing. An evidentiary hearing will not be granted on issues of policy or law. (2) There is a reasonable possibility that available evidence identified by the requestor would, if established, resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary.... (3) Resolution of the factual issue(s) in the manner sought by the person requesting the hearing would be adequate to justify the action requested.... 40 C.F.R. § 178.32(b). After considering the objections and requests for a hearing, EPA must issue a final order stating the action taken on each objection and request for a hearing. 21 U.S.C. § 346a(g)(2)(C). Any person who will be adversely affected by such order may obtain judicial review by filing an appeal in the appropriate circuit court of appeals. Id. § 346a(h)(1). Where such a person also challenge[s] the registration of pesticides under FIFRA, but does so only through a challenge to the tolerances set under the FDCA, such a challenge represent[s] an issue as to which review is... obtainable under Section 346a(h) in the appropriate circuit court of appeals. Johnson, 461 F.3d at 176 (internal quotation marks omitted).