65 FR 181 pgs. 56253-56255 - Hexythiazox; Extension of Tolerance for EmergencyExemptions
Type: RULEVolume: 65Number: 181Pages: 56253 - 56255
Docket number: [OPP-301046; FRL-6744-5]
FR document: [FR Doc. 00-23949 Filed 9-15-00; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301046; FRL-6744-5]
RIN 2070-AB78
Hexythiazox; Extension of Tolerance for EmergencyExemptions
AGENCY:
Environmental Protection Agency (EPA).
ACTION:
Final rule.
SUMMARY:
This regulation extends and re-establishestime-limited tolerances for combined residues of the insecticidehexythiazox(trans-5-(4-chlorophenyl)-N-cyclohexyl-4-methyl-2-oxothiazolidine-3-carboxamide)and its metabolite containing(4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moietyat 3.0 ppm on strawberry; 0.1 ppm on dates; 0.1 ppm on cottonseed, undelinted; and 2.0 ppm on cotton gin byproducts for anadditional 2-year period. These tolerances will expire andbe revoked on October 31, 2002. This action is in response toEPA's granting of an emergency exemption under section 18 of theFederal Insecticide, Fungicide, and Rodenticide Act authorizinguse of the pesticide on strawberry, dates, and cotton. Section408(l)(6) of the Federal Food, Drug, and Cosmetic Act requiresEPA to establish a time-limited tolerance or exemption from therequirement for a tolerance for pesticide chemical residues infood that will result from the use of a pesticide under anemergency exemption granted by EPA under section 18 of theFederal Insecticide, Fungicide, and Rodenticide Act.
DATES:
This regulation is effective September 18, 2000. Objections and requests for hearings, identifiedby docket control number OPP-301046, must be received byEPA on or before November 17, 2000.
ADDRESSES:
Written objections and hearing requestsmay be submitted by mail, in person, or by courier. Pleasefollow the detailed instructions for each method as provided inUnit III. of the SUPPLEMENTARY INFORMATION. Toensure proper receipt by EPA, your objections and hearingrequests must identify docket control number OPP-301046 inthe subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT:
By mail: DavidDeegan, Registration Division (7505C), Office of PesticidePrograms, Environmental Protection Agency, 1200 PennsylvaniaAve., NW., Washington, DC 20460; telephone number:703-308-9358; and e-mail address:deegan.dave@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are an agriculturalproducer, food manufacturer, or pesticide manufacturer.Potentially affected categories and entities may include, but arenot limited to:
| Categories | NAICS Codes | Examples of 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 ratherprovides a guide for readers regarding entities likely to beaffected by this action. Other types of entities not listed inthe table could also be affected. The North American IndustrialClassification System (NAICS) codes have been provided to assistyou and others in determining whether or not this action mightapply to certain entities. If you have questions regarding theapplicability of this action to a particular entity, consult theperson listed under FOR FURTHER INFORMATIONCONTACT.
B. How Can I Get Additional Information, Including Copies ofthis Document and Other Related Documents?
1. Electronically .You may obtain electroniccopies of this document, and certain other related documents thatmight be available electronically, from the EPA Internet HomePage at http://www.epa.gov/. To access this document, on theHome Page select "Laws and Regulations,""Regulations and Proposed Rules," and then look upthe entry for this document under the " FederalRegister -Environmental Documents." You can alsogo directly to the Federal Register listings athttp://www.epa.gov/fedrgstr/.
2. In person . The Agency has established anofficial record for this action under docket control numberOPP-301046. The official record consists of the documentsspecifically referenced in this action, and other informationrelated to this action, including any information claimed asConfidential Business Information (CBI). This official recordincludes 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 anyinformation claimed as CBI. The public version of the officialrecord, which includes printed, paper versions of any electroniccomments submitted during an applicable comment period isavailable for inspection in the Public Information and RecordsIntegrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m.,Monday through Friday, excluding legal holidays. The PIRIBtelephone number is (703) 305-5805.
II. Background and Statutory Findings
EPA issued two final rules, one published in the Federal Register of October 13, 1998 (63 FR 54594)(FRL-6030-3), and the other published in the Federal Register of November 26, 1997 (62 FR 62986)(FRL-5750-9), which announced that on its owninitiative under section 408 of the Federal Food, Drug, andCosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the FoodQuality Protection Act of 1996 (FQPA) (Public Law 104-170)it established time-limited tolerances for the combined residuesof hexythiazox and its metabolites at 3.0 ppm on strawberry; at0.1 ppm on dates; and at 0.1 ppm on cotton, undelinted seed; andat 2.0 ppm on cotton gin byproducts, with expiration dates ofSeptember 15, 2000 (strawberry and dates) and October 1, 1999(cotton). EPA established the tolerances because section408(l)(6) of the FFDCA requires EPA to establish a time-limitedtolerance or exemption from the requirement for a tolerance forpesticide chemical residues in food that will result from the useof a pesticide under an emergency exemption granted by EPA undersection 18 of the Federal Insecticide, Fungicide, and RodenticideAct (FIFRA). Such tolerances can be established without providingnotice or period for public comment.
EPA received requests to extend the use of hexythiazox onstrawberry, dates, and on cotton for this year's growing seasondue to the continued lack of effective registered products tocontrol mite species in the cultivation of these crops. Afterhaving reviewed each submission, EPA concurs that emergencyconditions continue to exist. EPA has authorized under FIFRAsection 18 the use of hexythiazox on strawberry, dates, and oncotton for control of various mite species in California (allthree commodities) and Florida (strawberry only).
EPA assessed the potential risks presented by residues ofhexythiazox in or on strawberry, dates, and cotton. In doingso, EPA considered the safety standard in FFDCA section408(b)(2), and decided that the necessary tolerance under FFDCAsection 408(l)(6) would be consistent with the safety standardand with FIFRA section 18. The data and other relevant materialhave been evaluated and discussed in the final rule of October13, 1998 (63 FR 54594). Based on that data and informationconsidered, the Agency reaffirms that extension of thetime-limited tolerance will continue to meet the requirements ofsection 408(l)(6). Therefore, the time-limited tolerances areextended (in the case of strawberry and dates) and re-established(in the case of cotton) for an additional 2-year period.EPA will publish a document in the Federal Register to remove the revoked tolerance from the Code of FederalRegulations (CFR). Although these tolerances will expire and berevoked on October 31, 2002, under FFDCA section 408(l)(5),residues of the pesticide not in excess of the amounts specifiedin the tolerance remaining in or on strawberry, dates, and cottonafter that date will not be unlawful, provided the pesticide isapplied in a manner that was lawful under FIFRA and theapplication occurred prior to the revocation of the tolerance.EPA will take action to revoke this tolerance earlier if anyexperience with, scientific data on, or other relevantinformation on this pesticide indicate that the residues are notsafe.
III. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, anyperson may file an objection to any aspect of this regulation andmay also request a hearing on those objections. The EPAprocedural regulations which govern the submission of objectionsand requests for hearings appear in 40 CFR part 178. Althoughthe procedures in those regulations require some modification toreflect the amendments made to the FFDCA by the FQPA of 1996, EPAwill continue to use those procedures, with appropriateadjustments, until the necessary modifications can be made. Thenew section 408(g) provides essentially the same process forpersons to "object" to a regulation for an exemptionfrom the requirement of a tolerance issued by EPA under newsection 408(d), as was provided in the old FFDCA sections 408 and409. However, the period for filing objections is now 60 days,rather than 30 days.
A. What Do I Need to Do to File an Objection or Request aHearing?
You must file your objection or request ahearing on this regulation in accordance with the instructionsprovided in this unit and in 40 CFR part 178. To ensure properreceipt by EPA, you must identify docket control numberOPP-301046 in the subject line on the first page of yoursubmission. All requests must be in writing, and must be mailedor delivered to the Hearing Clerk on or before November 17, 2000.
1. Filing the request . Your objection mustspecify the specific provisions in the regulation that you objectto, and the grounds for the objections (40 CFR 178.25). If ahearing is requested, the objections must include a statement ofthe factual issues(s) on which a hearing is requested, therequestor's contentions on such issues, and a summary of anyevidence relied upon by the objector (40 CFR 178.27).Information submitted in connection with an objection or hearingrequest may be claimed confidential by marking any part or all ofthat information as CBI. Information so marked will not bedisclosed except in accordance with procedures set forth in 40CFR part 2. A copy of the information that does not contain CBImust be submitted for inclusion in the public record. Informationnot marked confidential may be disclosed publicly by EPA withoutprior notice.
Mail your written request to: Office of the Hearing Clerk(1900), Environmental Protection Agency, 1200 Pennsylvania Ave.,NW., Washington, DC 20460. You may also deliver your request tothe Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401M St., SW., Washington, DC 20460. The Office of the HearingClerk is open from 8 a.m. to 4 p.m., Monday through Friday,excluding legal holidays. The telephone number for the Office ofthe Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment . If you file anobjection or request a hearing, you must also pay the feeprescribed by 40 CFR 180.33(i) or request a waiver of that feepursuant to 40 CFR 180.33(m). You must mail the fee to: EPAHeadquarters Accounting Operations Branch, Office of PesticidePrograms, P.O. Box 360277M, Pittsburgh, PA 15251. Pleaseidentify the fee submission by labeling it "TolerancePetition Fees."
EPA is authorized to waive any fee requirement "when inthe judgement of the Administrator such a waiver or refund isequitable and not contrary to the purpose of thissubsection." For additional information regarding thewaiver of these fees, you may contact James Tompkins by phone at(703) 305-5697, by e-mail at tompkins.jim@epa.gov, or bymailing a request for information to Mr. Tompkins at RegistrationDivision (7505C), Office of Pesticide Programs, EnvironmentalProtection Agency, 1200 Pennsylvania Ave., NW., Washington, DC20460.
If you would like to request a waiver of the toleranceobjection fees, you must mail your request for such a waiver to:James Hollins, Information Resources and Services Division(7502C), Office of Pesticide Programs, Environmental ProtectionAgency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
3. Copies for the Docket . In addition tofiling an objection or hearing request with the Hearing Clerk asdescribed in Unit III.A., you should also send a copy of yourrequest to the PIRIB for its inclusion in the official recordthat is described in Unit I.B.2. Mail your copies, identified bydocket control number OPP-301046 to: Public Information andRecords Integrity Branch, Information Resources and ServicesDivision (7502C), Office of Pesticide Programs, EnvironmentalProtection Agency, 1200 Pennsylvania Ave., NW., Washington, DC20460. In person or by courier, bring a copy to the location ofthe PIRIB described in Unit I.B.2. You may also send anelectronic copy of your request via e-mail to:opp-docket@epa.gov. Please use an ASCII file format and avoidthe use of special characters and any form of encryption. Copiesof electronic objections and hearing requests will also beaccepted on disks in WordPerfect 6.1/8.0 file format or ASCIIfile format. Do not include any CBI in your electronic copy.You may also submit an electronic copy of your request at manyFederal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administratordetermines that the material submitted shows the following: Thereis a genuine and substantial issue of fact; there is a reasonablepossibility that available evidence identified by the requestorwould, if established resolve one or more of such issues in favorof the requestor, taking into account uncontested claims or factsto the contrary; and resolution of the factual issues(s) in themanner sought by the requestor would be adequate to justify theaction requested (40 CFR 178.32).
IV. Regulatory Assessment Requirements
This final rule establishes a time-limited tolerance underFFDCA section 408. The Office of Management and Budget (OMB) hasexempted these types of actions from review under Executive Order12866, entitled Regulatory Planning and Review (58FR 51735, October 4, 1993). This final rule does not contain anyinformation collections subject to OMB approval under thePaperwork Reduction Act (PRA), 44 U.S.C. 3501 etseq. , or impose any enforceable duty or contain any unfundedmandate as described under Title II of the Unfunded MandatesReform Act of 1995 (UMRA) (Public Law 104-4). Nor does itrequire any prior consultation as specified by Executive Order13084, entitled Consultation and Coordination withIndian Tribal Governments (63 FR 27655, May 19, 1998);special considerations as required by Executive Order 12898,entitled Federal Actions to Address EnvironmentalJustice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or require OMB review or anyAgency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks andSafety Risks (62 FR 19885, April 23, 1997). This action doesnot involve any technical standards that would require Agencyconsideration of voluntary consensus standards pursuant tosection 12(d) of the National Technology Transfer and AdvancementAct of 1995 (NTTAA), Public Law 104-113, section 12(d) (15U.S.C. 272 note). Since tolerances and exemptions that areestablished on the basis of a FIFRA section 18 petition underFFDCA section 408, such as the tolerance in this final rule, donot require the issuance of a proposed rule, the requirements ofthe Regulatory Flexibility Act (RFA) (5 U.S.C. 601 etseq. ) do not apply. In addition, the Agency has determinedthat this action will not have a substantial direct effect onStates, on the relationship between the national government andthe States, or on the distribution of power and responsibilitiesamong the various levels of government, as specified in ExecutiveOrder 13132, entitled Federalism (64 FR 43255,August 10, 1999). Executive Order 13132 requires EPA to developan accountable process to ensure "meaningful and timelyinput by State and local officials in the development ofregulatory policies that have federalism implications.""Policies that have federalism implications" isdefined in the Executive Order to include regulations that have"substantial direct effects on the States, on therelationship between the national government and the States, oron the distribution of power and responsibilities among thevarious levels of government." This final rule directlyregulates growers, food processors, food handlers and foodretailers, not States. This action does not alter therelationships or distribution of power and responsibilitiesestablished by Congress in the preemption provisions of FFDCAsection 408(n)(4).
V. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 etseq. , as added by the Small Business Regulatory EnforcementFairness Act of 1996, generally provides that before a rule maytake effect, the agency promulgating the rule must submit a rulereport, which includes a copy of the rule, to each House of theCongress and to the Comptroller General of the United States.EPA will submit a report containing this rule and other requiredinformation to the U.S. Senate, the U.S. House ofRepresentatives, and the Comptroller General of the United Statesprior to publication of this final rule in the FederalRegister .This final rule is not a "major rule" as defined by 5U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice andprocedure, Agricultural commodities, Pesticides and pests,Reporting and recordkeeping requirements.
Dated: September 8, 2000.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180-[AMENDED]
1. The authority citation for part 180 continues to readas follows:
Authority:
21 U.S.C. 321(q), (346a) and 371.
§ 180.448 [Amended]
2. In § 180.448, amend the table in paragraph(b) by revising the date "10/1/99" to read"10/31/02" and "9/15/00" to read"10/31/02" wherever it appears.
[FR Doc. 00-23949 Filed 9-15-00; 8:45 am]
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