Nader v. United States Environmental Protection Agency

859 F.2d 747
CourtCourt of Appeals for the Ninth Circuit
DecidedOctober 14, 1988
DocketNo. 87-7103
StatusPublished
Cited by4 cases

This text of 859 F.2d 747 (Nader 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
Nader v. United States Environmental Protection Agency, 859 F.2d 747 (9th Cir. 1988).

Opinion

FLETCHER, Circuit Judge:

This case requires us to decide for the first time whether the EPA’s denial of a citizens’ rulemaking petition may be directly appealed to this court pursuant to 21 U.S.C. § 346a(i) or 21 U.S.C. § 348(g).

After several disputed scientific studies suggested that the pesticide daminozide may cause tumors, respondent EPA conducted a special review to decide whether to revoke the tolerance for daminozide. On [748]*748the basis of its Scientific Advisory Panel’s decision that the studies were inconclusive, the Agency decided not to revoke the tolerances. Instead, it proposed in April, 1986, to reduce the tolerance from 30 parts per million to 20 ppm. In July 1986, while EPA’s proposed rule was still pending, petitioners filed a petition under 21 U.S.C. §§ 346a and 348 asking the Agency to revoke the tolerance altogether. 21 U.S.C. § 346a(e) provides that the Administrator “may” propose regulations when asked by an interested person to do so, but imposes no express duty on the Administrator. On January 6, 1987, EPA denied the petition. Ten days later, on January 16, it published a final regulation reducing the tolerance for daminozide from 30 ppm to 20 ppm.

Petitioners appeal the denial of their petition. They contend that 21 U.S.C. §§ 346a(i) and 348 grant this court jurisdiction to review EPA’s denial. Because petitioners failed to comply with procedural prerequisites for review under § 348(g) and because we find no appealable order for purposes of § 346a(i), we dismiss for want of jurisdiction.

BACKGROUND

A. Statutory Framework

The Environmental Protection Agency (EPA or Agency) regulates pesticides under two separate statutes — the Federal Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. §§ 301-392, and the Federal Insecticide, Fungicide and Rodenticide Act (FI-FRA), 7 U.S.C. §§ 136-136y. Before a pesticide may be sold or distributed in the United States, it must be registered by EPA under FIFRA. A pesticide may be registered only if it does not cause “unreasonable adverse effects” on human health or the environment, a standard that is applied by weighing the benefits of a pesticide against its risks. 7 U.S.C. §§ 136a, 136(bb).

Under the FDCA, no residue of a pesticide not generally recognized as safe may be present on a raw agricultural commodity unless the Agency has established a “tolerance” or an exemption from the requirement of a tolerance. 21 U.S.C. § 346a(a). A tolerance is the maximum allowable amount of pesticide that may remain in or on a commodity. Under section 346a(b), the Administrator must issue a regulation establishing a tolerance for the pesticide “to the extent necessary to protect the public health.” In establishing a tolerance, the Administrator is to “give appropriate consideration, among other relevant factors, [] to the necessity for the production of an adequate, wholesome, and economical food supply.” Id. The Administrator may set the tolerance at zero if the available scientific data do not justify the establishment of a greater tolerance. Id.

In addition to establishing tolerances for raw products, the Agency may set tolerances for pesticide residues in processed foods. 21 U.S.C. § 348(d).1 Absent such a tolerance, a processed food bearing residues at levels in excess of that authorized in the raw product is considered “adulterated” and prohibited in interstate commerce. 21 U.S.C. § 342(a)(2)(C). Section 348 also contains a provision known as the “Delaney clause,” which dictates that “no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal_” 21 U.S.C. § 348(c)(3)(A).

Both section 346a and 348 permit persons outside the EPA to request the Agency to set a tolerance. Section 346a(e) provides:

The Administrator may at any time, upon his own initiative or upon the request of any interested person, propose the issuance of a regulation establishing a tolerance for a pesticide chemical....

If within 30 days of the publication of such a proposal, there has been no request for an advisory committee, the Administrator “may by order publish a regulation based upon the proposal[.]” Id.

Similarly, section 348 permits “any person” to file a petition proposing the is[749]*749suance of a regulation prescribing, among other things, a tolerance level. 21 U.S.C. § 348(b). Thereafter, the Administrator must, by order, either establish a regulation or deny the petition. 21 U.S.C. § 348(c).

B. Administrative Proceedings

The pesticide at issue in this case is daminozide, a plant growth regulator the principal use of which is on apples. Dami-nozide is sold by respondent Uniroyal under the trademark name “Alar.” First registered in 1963, it was approved for use on apples in 1968. Alar reduces crop losses and lowers harvesting costs by preventing the fruit from dropping off the trees prior to harvest. It also reduces many fruit disorders, increases fruit size, and enhances the firmness of the apples, enabling them to be stored and marketed throughout the year.

Unfortunately, there is also evidence to suggest that daminozide or its degradation product, unsymmetrical dimethylhydrazine (UDMH), may be an animal carcinogen. Five scientific studies conducted between 1973 and 1984 demonstrated with statistically significant results a correlation between ingestion of Alar and various types of tumors in certain lab animals. Both the methodology and the results of these studies have been questioned, however, and the parties in this case disagree as to their significance.

The studies aroused sufficient concern at the EPA that in June 1984 the Agency stated that based on its review of the data, it had “concluded that daminozide and its UDMH hydrolosis product are oncogenic [tumor causing] in laboratory rats and mice.” Guidance for the Interim Registration of Pesticide Products Containing Dam-inozide as the Active Ingredient at 12.

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Bluebook (online)
859 F.2d 747, Counsel Stack Legal Research, https://law.counselstack.com/opinion/nader-v-united-states-environmental-protection-agency-ca9-1988.