Federal Register: June 5, 2001 (Volume 66, Number 108)
DOCID: FR Doc 01-14085
ENVIRONMENTAL PROTECTION AGENCY
Environmental Protection Agency
CFR Citation: 40 CFR Part 180
RIN ID: RIN 2070-AB78
OPP ID: [OPP-301131; FRL-6782-5]
ACTION: Pesticides; tolerances in food, animal feeds, and raw agricultural commodities:
DOCUMENT ACTION: Final rule.
Pyriproxyfen; Pesticide Tolerance
DATES: This regulation is effective June 5, 2001. Objections and requests for hearings, identified by docket control number OPP301131, must be received by EPA on or before August 6, 2001.
This regulation establishes a tolerance for residues of pyriproxyfen in or on pistachio. The Interregional Research Project Number 4 (IR4) requested this tolerance under the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act of 1996.
I. General 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 codes potentially affected entities Industry 111 Crop production 112 Animal production 311 Food manufacturing 32532 Pesticide manufacturing
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 [[Page 30066]]
the entry for this document under the ``Federal RegisterEnvironmental Documents.'' You can also go directly to theFederal Register listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/ nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/ opptsfrs/home/guidelin.htm.
2. In person. The Agency has established an official record for this action under docket control number OPP301131. 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 April 4, 2001 (66 FR 17883) (FRL6772 4), 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 0E6081) for tolerance by IR4, Technology Center of New Jersey, Rutgers, The State University of New Jersey, 681 U.S. Highway #1 South, North Brunswick, NJ 089023390. This notice included a summary of the petition prepared by Valent U.S.A. Corporation, 1333 North California Blvd., P.O. Box 8025, Walnut Creek, CA 945968025, the registrant. There were no comments received in response to the notice of filing.
The petition requested that 40 CFR 180.510 be amended by establishing a tolerance for residues of the insecticide pyriproxyfen, 2[1methyl2(4phenoxyphenoxy)ethoxypyridine, in or on pistachio at 0.02 part per million (ppm).
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 pyriproxyfen on pistachio at 0.2 ppm. 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 nature of the toxic effects caused by pyriproxyfen 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.
Table 1.Subchronic, Chronic, and Other Toxicity Guideline No. Study Type Results 870.3100 Subchronic feeding in rats NOAEL = 23.49 mg/kg/day in males 27.68 mg/ (13 weeks) kg/day in females LOAEL = 117.79 milligram/kilogram/day (mg/ kg/day) in males and 141.28 mg/kg/day in females based on higher mean total cholesterol and phospholipids; decreased mean red blood cells, hematocrit and hemoglobin counts and increased liver weight. 870.3150 Subchronic oral toxicity in NOAEL = 100 mg/kg/day dogs (13 weeks) LOAEL = 300 mg/kg/day based on increased absolute and relative liver weight in males and hepatocellular hypertrophy in females. These findings were also observed at 1,000 mg/kg/day and may represent adaptive changes at both 300 mg/kg/day and the limit dose of 1,000 mg/ kg/day. 870.3200 21Day dermal toxicity NOAEL = >1,000 mg/kg/day (rat) There was no dermal or systemic toxicity at the 1,000 mg/kg/day dose, highest dose tested (HDT). [[Page 30067]]
870.3700a Prenatal developmental Maternal NOAEL = 100 mg/kg/day (rat) LOAEL = 300 mg/kg/day based on increased incidences in mortality and clinical signs at 1,000 mg/kg/day with decreases in food consumption, body weight, and body weight gain together with increases in water consumption at 300 and 1,000 mg/ kg/day. Developmental NOAEL = 300 mg/kg/day LOAEL = 1,000 mg/kg/day based on increased incidences of skeletal variations and unspecified visceral variations at 1,000 mg/kg/day. 870.3700b Prenatal developmental Maternal NOAEL = 100 mg/kg/day (rabbit) LOAEL = 300 mg/kg/day based on based on premature delivery/abortions, soft stools, emaciation, decreased activity and bradypnea. Developmental NOAEL = 300 mg/kg/day LOAEL = 1,000 mg/kg/day. There were no effects observed in the 4 litters examined. 870.3800 Reproduction and fertility Parental/systemic NOAEL = 76 mg/kg/day in effects (rat) males and 87 mg/kg/day in females LOAEL = 386 mg/kg/day and males 442mg/kg/ day in females based on decreased body weight, weight gain and food consumption in both sexes and both generations. Increased liver weight in both sexes of the F
FOR FURTHER INFORMATION CONTACT
By mail: Hoyt Jamerson, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460; telephone number: (703) 3089368; and email address: