65 FR 235 pgs. 76169-76171 - Fludioxonil; Extension of Tolerance for Emergency Exemptions
Type: RULEVolume: 65Number: 235Pages: 76169 - 76171
Docket number: [OPP-301083; FRL-6756-6]
FR document: [FR Doc. 00-31054 Filed 12-5-00; 8:45 a.m.]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301083; FRL-6756-6]
RIN 2070-AB78
Fludioxonil; Extension of Tolerance for Emergency Exemptions
AGENCY:
Environmental Protection Agency (EPA).
ACTION:
Final rule.
SUMMARY:
This regulation extends a time-limited tolerance forresidues of the fungicide fludioxonil in or on caneberries at 2 parts per million (ppm) foran additional 1-year period. This tolerance will expire and is revoked on December 31, 2001.This action is in response to EPA's granting of emergency exemptions under section 18 of theFederal Insecticide, Fungicide, and Rodenticide Act authorizing use of the pesticide oncaneberries. Section 408(l)(6) of the Federal Food, Drug, and Cosmetic Act requires EPA toestablish a time-limited tolerance or exemption from the requirement for a tolerance for pesticidechemical residues in food that will result from the use of a pesticide under an emergencyexemption granted by EPA under section 18 of the Federal Insecticide, Fungicide, andRodenticide Act.
DATES:
This regulation is effective December 6, 2000. Objections and requests for hearings, identified by docket control number OPP-301083, must be received by EPA on or before February 5, 2001.
ADDRESSES:
Written objections and hearing requests may besubmitted by mail, in person, or by courier. Please follow the detailed instructions for each method as provided in Unit III. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your objections and hearing requests must identify docket control number OPP-301083 in the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT:
By mail:Stephen Schaible, Registration Division (7505C), Office of Pesticide Programs,Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 308-9362; and e-mail address:schaible.stephen@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 agricultural producer, foodmanufacturer, or pesticide manufacturer. Potentially affected categories and entities mayinclude, but are not 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 rather provides a guide for readersregarding entities likely to be affected by this action. Other types of entities not listed in thetable 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 actionmight apply to certain entities. If you have questions regarding the applicability of this action toa 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 ProposedRules," and then look up the entry for this document under the " Federal Register -Environmental Documents." You canalso go directly to the Federal Register listings athttp://www.epa.gov/fedrgstr/.
2. In person . The Agency has established an official recordfor this action under docket control number OPP-301083. The official recordconsists of the documents specifically referenced in this action, and other information related tothis action, including any information claimed as Confidential Business Information (CBI). Thisofficial record includes the documents that are physically located in the docket, as well as thedocuments that are referenced in those documents. The public version of the official record doesnot include any information claimed as CBI. The public version of the official record, whichincludes printed, paper versions of any electronic comments submitted during an applicablecomment period is available for inspection in the Public Information and Records IntegrityBranch (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 PIRIBtelephone number is (703) 305-5805.
II. Background and Statutory Findings
EPA issued a final rule, published in the Federal Register of June 30, 1999 (64 FR 35037) (FRL-6086-4), which announced that on its owninitiative under 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 Law104-170) it established a time-limited tolerance for the residues of fludioxonil inor on caneberries at 2 ppm, with an expiration date of December 31, 2000. EPAestablished the tolerance because section 408(l)(6) of the FFDCA requires EPA to establish atime-limited tolerance or exemption from the requirement for a tolerance for pesticide chemicalresidues in food that will result from the use of a pesticide under an emergency exemptiongranted by EPA under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act(FIFRA). Such tolerances can be established without providing notice or period for public comment.
EPA received a request to extend the use of fludioxonil on caneberries for thisyear's growing season due to the widespread development of pest resistance to previously-used standard fungicides benomyl, iprodione and vinclozolin; no currently availablealternatives appear to provide suitable disease control and significant economic losses areexpected with moderate to severe disease pressure. After having reviewed the submission,EPA concurs that emergency conditions exist. EPA has authorized under FIFRA section 18 the use of fludioxonil on caneberries for control of gray mold in Oregon and Washington.
EPA assessed the potential risks presented by residues of fludioxonil in or oncaneberries. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2),and decided that the necessary tolerance under FFDCA section 408(l)(6) would be consistentwith the safety standard and with FIFRA section 18. The data and other relevant material havebeen evaluated and discussed in the final rule of June 30, 1999 (64 FR 35037) (FRL-6086-4). Based on that data and information considered, the Agency reaffirms thatextension of the time-limited tolerance will continue to meet the requirements of section408(l)(6). Therefore, the time-limited tolerance is extended for an additional 1-year period.EPA will publish a document in the Federal Register to remove therevoked tolerance from the Code of Federal Regulations (CFR). Although this tolerance willexpire and is revoked on December 31, 2001, under FFDCA section 408(l)(5), residues of thepesticide not in excess of the amounts specified in the tolerance remaining in or on caneberriesafter that date will not be unlawful, provided the pesticide is applied in a manner that was lawfulunder FIFRA and the application occurred prior to the revocation of the tolerance. EPA will takeaction to revoke this tolerance earlier if any experience with, scientific data on, or other relevantinformation on this pesticide indicate that the residues are not safe.
III. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any person mayfile an objection to any aspect of this regulation and may also request a hearing on thoseobjections. The EPA procedural regulations which govern the submission of objections andrequests for hearings appear in 40 CFR part 178. Although the procedures in those regulationsrequire some modification to reflect the amendments made to the FFDCA by the FQPA of 1996,EPA will continue to use those procedures, with appropriate adjustments, until the necessarymodifications can be made. The new section 408(g) provides essentially the same process forpersons to "object" to a regulation for an exemption from the requirementof a tolerance issued by EPA under new section 408(d), as was provided in the old FFDCAsections 408 and 409. However, the period for filing objections is now 60 days, rather than 30days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this regulation in accordancewith the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt byEPA, you must identify docket control number OPP-301083 in the subject line onthe first page of your submission. All requests must be in writing, and must be mailed ordelivered to the Hearing Clerk on or before February 5, 2001.
1. Filing the request . Your objection must specify thespecific provisions in the regulation that you object to, and the grounds for the objections (40CFR 178.25). If a hearing is requested, the objections must include a statement of the factualissues(s) on which a hearing is requested, the requestor's contentions on such issues, and asummary of any evidence relied upon by the objector (40 CFR 178.27). Information submittedin connection with an objection or hearing request may be claimed confidential by marking anypart or all of that information as CBI. Information so marked will not be disclosed except inaccordance with procedures set forth in 40 CFR part 2. A copy of the information that does notcontain CBI must be submitted for inclusion in the public record. Information not markedconfidential may be disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900), EnvironmentalProtection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may alsodeliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St.,SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m.,Monday through Friday, excluding legal holidays. The telephone number for the Office of theHearing Clerk is (202) 260-4865.
2. Tolerance fee payment . If you file an objection or requesta hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of thatfee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters AccountingOperations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251.Please identify the fee submission by labeling it "Tolerance Petition Fees."
EPA is authorized to waive any fee requirement "when in the judgementof the Administrator such a waiver or refund is equitable and not contrary to the purpose of thissubsection." For additional information regarding the waiver of these fees, you maycontact James Tompkins by phone at (703) 305-5697, by e-mail attompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins atRegistration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency,1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection fees, you must mailyour request for such a waiver to: James Hollins, Information Resources and Services Division(7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 PennsylvaniaAve., NW., Washington, DC 20460.
3. Copies for the Docket . In addition to filing an objectionor hearing request with the Hearing Clerk as described in Unit III.A., you should also send acopy of your request to the PIRIB for its inclusion in the official record that is described in UnitI.B.2. Mail your copies, identified by docket control number OPP-301083, to:Public Information and Records Integrity Branch, Information Resources and Services Division(7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 PennsylvaniaAve., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of thePIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mailto: opp-docket@epa.gov. Please use an ASCII file format and avoid the use ofspecial characters and any form of encryption. Copies of electronic objections and hearingrequests will also be accepted on disks in WordPerfect 6.1/8.0 file format or ASCII file format.Do not include any CBI in your electronic copy. You may also submit an electronic copy ofyour request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator determines that thematerial submitted shows the following: There is a genuine and substantial issue of fact; there isa reasonable possibility that available evidence identified by the requestor would, if establishedresolve one or more of such issues in favor of the requestor, taking into account uncontestedclaims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by therequestor would be adequate to justify the action requested (40 CFR 178.32).
IV. Regulatory Assessment Requirements
This final rule extends the expiration date of a time-limited tolerance under FFDCA section 408. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). This final rule does not contain anyinformation collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995(UMRA) (Public Law 104-4). Nor does it require any prior consultation as specifiedby Executive Order 13084, entitled Consultation and Coordination with IndianTribal Governments (63 FR 27655, May 19, 1998); special considerations as required byExecutive Order 12898, entitled Federal Actions to Address Environmental Justicein Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994);or require OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62FR 19885, April 23, 1997). This action does not involve any technical standards that wouldrequire Agency consideration of voluntary consensus standards pursuant to section 12(d) of theNational Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions thatare established on the basis of a FIFRA section 18 petition under FFDCA section 408, such asthe tolerance in this final rule, do not require the issuance of a proposed rule, the requirementsof the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do notapply. In addition, the Agency has determined that this action will not have a substantial directeffect on States, on the relationship between the national government and the States, or on thedistribution of power and responsibilities among the various levels of government, as specified inExecutive Order 13132, entitled Federalism (64 FR 43255, August 10,1999). Executive Order 13132 requires EPA to develop an accountable process to ensure"meaningful and timely input by State and local officials in the development ofregulatory policies that have federalism implications." "Policies that havefederalism implications" is defined in the Executive Order to include regulations thathave "substantial direct effects on the States, on the relationship between the nationalgovernment and the States, or on the distribution of power and responsibilities among the variouslevels of government." This final rule directly regulates growers, food processors,food handlers and food retailers, not States. This action does not alter the relationships ordistribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4).
V. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq. , asadded by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register . This final rule is not a "major rule" as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Dated: November 22, 2000.
James Jones,
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 read as follows:
Authority:
21 U.S.C. 321(q), (346a) and 371.
§ 180.516 [Amended]
2. In § 180.516, by amending the table in paragraph (b), by revising the expiration/revocation date for Caneberries from "12/31/00" to read "12/31/01".
[FR Doc. 00-31054 Filed 12-5-00; 8:45 a.m.]
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