Federal Register: August 18, 2000 (Volume 65, Number 161)
DOCID: FR Doc 00-21080
ENVIRONMENTAL PROTECTION AGENCY
Environmental Protection Agency
CFR Citation: 40 CFR Part 180
RIN ID: RIN 2070-AB78
OPP ID: [OPP-301037; FRL-6737-6]
ACTION: Pesticides; tolerances in food, animal feeds, and raw agricultural commodities:
DOCUMENT ACTION: Final rule.
Acibenzolar-S-Methyl; Pesticide Tolerance
DATES: This regulation is effective August 18, 2000. Objections and requests for hearings, identified by docket control number OPP301037 must be received by EPA on or before October 17, 2000.
This regulation establishes tolerances for residues of acibenzolarSmethyl in or on bananas; Brassica (cole) leafy vegetables; fruiting vegetables; tomato, paste; leafy vegetables (except spinach); and spinach. Novartis Crop Protection, Inc. requested these tolerances 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 Potentially Categories NAICS 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 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 OPP301037. 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. [[Page 50439]]
II. Background and Statutory Findings
In theFederal Register of February 18, 1999 (64 FR 8102) (FRL6061 4) and theFederal Register of February 4, 2000 (65 FR 5639) (FRL6398 9), EPA issued notices 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 pesticide petitions (PP) for tolerance by Novartis Crop Protection, Inc., P.O. Box 18300, Greensboro, NC 27419. These notices included summaries of the petitions prepared by Novartis Crop Protection, Inc., the registrant. There were no comments received in response to the notices of filing.
The petitions requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide acibenzolarS methyl, benzo(1,2,3)thiadiazole7carbothioic acidSmethyl ester, in or on bananas at 0.1 part per million (ppm), Brassica (cole) leafy vegetables at 1.0 ppm, fruiting vegetables at 1.0 ppm, leafy vegetables (except spinach) at 0.25 ppm and spinach at 1.0 ppm. Agency review of data submitted in support of the petitions indicated that a separate tolerance of 3.0 ppm for tomato, paste should also be established.
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 tolerances for residues of acibenzolarSmethyl on bananas at 0.1 ppm; Brassica (cole) leafy vegetables at 1.0 ppm; fruiting vegetables at 1.0 ppm; tomato, paste at 3.0 ppm; leafy vegetables (except spinach) at 0.25 ppm; and spinach at 1.0 ppm. EPA's assessment of exposures and risks associated with establishing the tolerances 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 acibenzolarS
methyl are discussed in this unit 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 90Day oral toxicity rats NOAEL: Males:126 mg/kg/day; Females: 131 mg/kg/day
FOR FURTHER INFORMATION CONTACT
By mail: Daniel Kenny, Acting PM-22,
Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave.,
NW.,Washington, DC 20460; telephone number: (703) 3057546; and email address: email@example.com.