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CFR Citation: 40 CFR Part 180

RIN ID: RIN 2070-AB

OPP ID: [OPP-301040; FRL-6740-1]

NOTICE: RULES

ACTION: Pesticides; tolerances in food, animal feeds, and raw agricultural commodities:

DOCUMENT ACTION: Final rule.

SUBJECT CATEGORY: Buprofezin (2-Tert-butylimino-3-isopropyl-5-phenyl-1,3,5- thiadiazinan-4-one); Time-Limited Pesticide Tolerances

DATES: This regulation is effective August 31, 2000. Objections and requests for hearings, identified by docket control number OPP301040, must be received by EPA on or before October 30, 2000.

DOCUMENT SUMMARY: This regulation establishes time-limited tolerances for residues of buprofezin in or on lettuce, head; lettuce, leaf; and vegetables, cucurbits. Aventis CropScience requested these tolerances under the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act of 1996. The tolerances will expire on December 31, 2004.

SUMMARY: Buprofezin,

SUPPLEMENTAL INFORMATION

A. Does this Action Apply to Me?

You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to: Examples of Categories NAICS Potentially Affected Entities Industry 111 Crop production 112 Animal production 311 Food manufacturing 32532 Pesticide manufacturing [[Page 52939]]

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.
B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?

1. Electronically.You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select ``Laws and Regulations,'' Regulations and Proposed Rules, and then look up the entry for this document under the ``Federal RegisterEnvironmental Documents.'' You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/.

2. In person. The Agency has established an official record for this action under docket control number OPP301040. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 3055805. II. Background and Statutory Findings

In the Federal Register of August 26, 1998 (63 FR 45483) (FRL5791 1), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104170) announcing the filing of a pesticide petition (PP) for tolerance by Aventis CropScience (formerly AgrEvo USA Company, 2 T.W. Alexander Drive, Research Triangle Park, N.C. 27709). This notice included a summary of the petition prepared by Aventis CropScience, the registrant. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR 180.511 be amended by establishing a tolerance for residues of the insecticide buprofezin, in or on lettuce, head; lettuce, leaf; and vegetables, cucurbits at 5.0, 13.0, and 0.50 parts per million (ppm), respectively. The tolerances will expire on December 31, 2004.

Buprofezin is an insecticide which will be sold under the trade name of Applaud 70WP. Buprofezin is a new insect growth regulator used for the control of several species of Homoptera spp., such as planthoppers, mealybugs, leafhoppers, whiteflies and scales. It is currently registered in 76 countries mainly for use on vegetables, cotton, citrus, rice and ornamentals.

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) defines ``safe'' 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.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and 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. . . .''

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL57547).

III. Aggregate Risk Assessment and Determination of Safety

Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a tolerance for residues of buprofezin on lettuce, head; lettuce, leaf; and vegetables, cucurbits at 5.0, 13.0, and 0.50 parts per million (ppm), respectively. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

The toxicological data base for buprofezin is adequate for selecting toxicity endpoints according to the Agency guideline requirements for a fooduse chemical by 40 CFR part 158. However, an additional developmental neurotoxicity study in rats is required to address Agency concerns raised from the presence of thyroid effects observed in rat and dog subchronic and/or chronic studies.

1. Acute toxicity. Buprofezin is classified by the Agency as toxicity Category III for acute oral and toxicity category IV for acute dermal toxicity, acute inhalation toxicity, eye irritation and dermal irritation, and is not a dermal sensitizer. The nature of the toxic effects caused by buprofezin are discussed in the following Table 1 as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed.
[[Page 52940]]
Table 1.Acute Toxicity Data on Buprofezin Technical* Guideline No. Study Type Results Toxicity Category 870.1100 Acute oral toxicity LD50 1,653 mg/kg males, III LD50 2,015 mg/kg females 870.1200 Acute dermal toxicity LD50 > 5,000 mg/kg IV 870.1300 Acute inhalation LC50 > 4.21 mg/L IV toxicity (estimated) 870.2400 Acute eye irritation Mild IV 870.2500 Acute dermal irritation Slight IV 870.2600 Skin sensitization Negative NA ^*Buprofezin Technical (99% a.i.)

2. Subcronic, chronic, and other toxicity. For subchronic toxicity, the primary effects of concern in the rat were increased microscopic lesions in male and female liver and thyroid, increased liver weights in males and females, and increased thyroid weight in males. Increased focal necrosis with an inflammatory infiltrate in the liver was observed in females following dermal subchronic exposure, as was increased acanthosis and hyperkeratosis in skin.

In chronic studies in the rat, an increased incidence of follicular cell hyperplasia and hypertrophy in the thyroid of males was reported. Increased relative liver weights were reported in female dogs. In the mouse, increased absolute liver weights in males and females, along with an increased incidence of hepatocellular adenomas and hepatocellular adenomas plus carcinomas in females were reported. The Agency has evaluated the carcinogenic potential of buprofezin, based on these liver tumors in female mice, and classified it as having ``Suggestive Evidence of Carcinogenicity, but not sufficient to assess human carcinogenic potential.''

The developmental toxicity study in the rat produced reduced ossification and reduced pup weight at maternally toxic doses (death, decreased pregnancy rates, and increased resorption rates). No developmental toxicity was observed in the rabbit at or below maternally toxic dose levels.

The reproductive toxicity study showed decreased pup body weights at dose levels where liver effects (increased relative and/or absolute liver weights) and decreased body weight gains were observed in the parental generations.

The data do not raise concern for susceptibility in offspring. The developmental and reproductive studies showed toxicity in the offspring only at dose levels that were toxic in the parent(s). The toxicity observed in the offspring was not more severe, qualitatively, than the toxicity observed in the parents.

The data do not indicate a basis for concern for neurotoxicity. Possible neurotoxicity (hunched positions, lethargy) was observed in the rat developmental toxicity study, at levels that caused death. In the 90day rat subchronic study, a 24% decrease in plasma
cholinesterase was reported in males and females at the high dose level. However, this was not correlated with any pathological observation or functional deficit. Neurotoxicity was not observed in any of the chronic studies in the rat, mouse, or dog.

There is no concern for mutagenic activity in several studies such as the Ames assay, forward mutation assay, mouse micronucleus assay, in vitro human cytogenetic assay, and unscheduled DNA synthesis.

A rat metabolism study indicated that 95% of the administered compound is recovered in the feces and urine within 72 hours, and that 45% is recovered as the parent compound, with the remainder as several metabolites. The nature of the toxic effects caused by buprofezin are discussed in the following Table 2 as well as the NOAEL and the LOAEL from the toxicity studies reviewed.
Table 2.Subchronic, Chronic, and Other Toxicity Guideline No. Study Type Results 870.3100 90Day oral NOAEL: 13.0 mg/kg/day toxicity rodents (Males or M); 16.3 (rat) mg/kg/day (Females or F)

FOR FURTHER INFORMATION CONTACT By mail: Richard J. Gebken, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 3056701; and email address: gebken.richard@epa.gov.