65 FR 144 pgs. 45922-45925 - Imidacloprid; Extension of Tolerance for Emergency Exemptions
Type: RULEVolume: 65Number: 144Pages: 45922 - 45925
Docket number: [OPP-301023; FRL-6597-1]
FR document: [FR Doc. 00-18908 Filed 7-25-00; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301023; FRL-6597-1]
RIN 2070-AB78
Imidacloprid; Extension of Tolerance for Emergency Exemptions
AGENCY:
Environmental Protection Agency (EPA).
ACTION:
Final rule.
SUMMARY:
This regulation extends time-limited tolerances for residuesof the insecticide imidacloprid and its metabolites in or on citrus fruits (crop group 10) at1.0 parts per million (ppm), dried citrus pulp at 5.0 ppm, legume vegetables (crop group 6)at 1.0 ppm, and strawberries at 0.1 ppm for an additional 2-year period. Thesetolerances will expire and are revoked on June 30, 2002. This action is in response to EPA'sgranting of emergency exemptions under section 18 of the Federal Insecticide, Fungicide, andRodenticide Act authorizing use of the pesticide on citrus, succulent beans (part of the legumevegetables crop group), and strawberries. Section 408(l)(6) of the Federal Food, Drug, andCosmetic Act requires EPA to establish a time-limited tolerance or exemption from therequirement for a tolerance for pesticide chemical residues in food that will result from the use ofa pesticide under an emergency exemption granted by EPA under section 18 of the FederalInsecticide, Fungicide, and Rodenticide Act.
DATES:
This regulation is effective July 26, 2000. Objections and requests for hearings, identified by docket control number OPP-301023, must be received by EPA on or before September 25, 2000.
ADDRESSES:
Written objections and hearing requests may besubmitted by mail, in person, or by courier. Please follow the detailed instructions for eachmethod as provided in Unit III. of the SUPPLEMENTARY INFORMATION. To ensureproper receipt by EPA, your objections and hearing requests must identify docket control numberOPP-301023 in the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT:
By mail:Andrew Ertman, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 308-9367; and e-mail address: ertman.andrew@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 | NAICScodes | Examples of potentially affectedentities |
|---|---|---|
| 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 OtherRelated Documents?
1. Electronically . You may obtain electronic copies of this document,and certain other related documents that might be available electronically, from the EPA InternetHome Page at http://www.epa.gov/. To access this document, on the Home Page select "Lawsand Regulations" and then look up the entry for this document under the " FederalRegister -Environmental Documents." You can also go directly to the FederalRegister listings at http://www.epa.gov/fedrgstr/.
2. In person . The Agency has established an official record for thisaction under docket control number OPP-301023. The official record consists of thedocuments specifically referenced in this action, and other information related to this action,including any information claimed as Confidential Business Information (CBI). This officialrecord includes the documents that are physically located in the docket, as well as the documentsthat are referenced in those documents. The public version of the official record does not includeany information claimed as CBI. The public version of the official record, which includesprinted, paper versions of any electronic comments submitted during an applicable commentperiod 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) 305-5805.
II. Background and Statutory Findings
EPA issued a final rule, published in the Federal Register of July 9, 1997 (62 FR 36691) (FRL-5729-4), which announced that on its own initiative under section 408 of theFederal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the FoodQuality Protection Act of 1996 (FQPA) (Public Law 104-170) it established time-limitedtolerances for the residues of imidacloprid and its metabolites in or on the citrus fruitscrop group at 1.0 part per million (ppm) and dried citrus pulp at 5.0 ppm, with anexpiration date of December 31, 1998. These tolerances were extended on December 2,1998 (63 FR 66438) (FRL-6037-2), for an additional 18-month period to June 30, 2000.
EPA issued a final rule, published in the Federal Register of January 20,1999 (64 FR 3037) (FRL-6051-6), which announced that on its own initiative under section 408of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by theFood Quality Protection Act of 1996 (FQPA) (Public Law 104-170) it established time-limited tolerances for the residues of imidacloprid and its metabolites in or on legumevegetables (crop group 6) at 1.0 ppm and strawberries at 0.1 ppm, with an expiration date of June 30, 2000.
EPA established the tolerances because section 408(l)(6) of the FFDCA 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 (FIFRA). Such tolerances can be established without providing notice or periodfor public comment.
EPA received a request to extend the use of imidacloprid on citrus for this year'sgrowing season due to an emergency concerning the spread of Pierce's Disease to wine grapesin California. By controlling the glassy-winged sharpshooter, the vector of Pierce's Diseasein citrus, the state hopes to prevent the spread of the disease to grapes.
EPA received a request to extend the use of imidacloprid on succulent beans (part ofthe legume vegetable crop group) for this year's growing season due to an emergency withsilverleaf whitefly on succulent beans in Georgia.
EPA received a request to extend the use of imidacloprid on strawberries for this year'sgrowing season due to the continuing emergency in California. California requested aspecific exemption for use of imidacloprid on strawberries to control the silverleaf whitefly.The situation in the state of California remains an emergency as there have been no adequatealternatives made available since the initial request for this use. An emergency situation ispresent due to this recently introduced pest, its devastating effects on many fruit and vegetablecrops, and its resistance to registered alternatives.
After having reviewed the submissions, EPA concurs that emergency conditions exist forthe situations in these states. EPA has authorized under FIFRA section 18 the use ofimidacloprid on citrus for control of the glassy-winged sharpshooter in California, the use ofimidacloprid on succulent beans for control of silverleaf whiteflies in Georgia, and the use ofimidacloprid on strawberries for control of silverleaf whiteflies in California.
EPA assessed the potential risks presented by residues of imidacloprid in or oncitrus, citrus pulp, legume vegetables, and strawberries. In doing so, EPA considered thesafety standard in FFDCA section 408(b)(2), and decided that the necessary tolerances underFFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section18. The data and other relevant material have been evaluated and discussed in the final rules ofJuly 9, 1997 (62 FR 36691) and January 20, 1999 (64 FR 3037). Based on that data and information considered, the Agencyreaffirms that extension of the time-limited tolerances will continue to meet the requirements ofsection 408(l)(6). Therefore, the time-limited tolerances are extended for an additional 2-yearperiod. EPA will publish a document in the Federal Register to remove therevoked tolerances from the Code of Federal Regulations (CFR). Although these tolerances willexpire and are revoked on June 30, 2002, under FFDCA section 408(l)(5), residues of thepesticide not in excess of the amounts specified in the tolerances remaining in or on citrus, driedcitrus pulp, legume vegetables, or strawberries after that date will not be unlawful, providedthe pesticide is applied in a manner that was lawful under FIFRA, and the application occurredprior to the revocation of the tolerances. EPA will take action to revoke these tolerances earlierif any experience with, scientific data on, or other relevant information on this pesticide indicatethat 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 requirement of a tolerance issuedby EPA under new section 408(d), as was provided in the old FFDCA sections 408 and 409.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 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-301023 in the subject line on thefirst page of your submission. All requests must be in writing, and must be mailed or deliveredto the Hearing Clerk on or before September 25, 2000.
1. Filing the request . Your objection must specify the specific provisions inthe regulation that you object to, and the grounds for the objections (40 CFR 178.25). If ahearing is requested, the objections must include a statement of the factual issues(s) on which ahearing is requested, the requestor's contentions on such issues, and a summary of any evidencerelied upon by the objector (40 CFR 178.27). Information submitted in connection with anobjection or hearing request may be claimed confidential by marking any part or all of thatinformation as CBI. Information so marked will not be disclosed except in accordance withprocedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI mustbe submitted for inclusion in the public record. Information not marked confidential may bedisclosed 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 also deliver your request to the Office of the Hearing Clerk in Rm. C400, WatersideMall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for theOffice of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment . If you file an objection or request ahearing, you must also pay the fee prescribed 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: 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 judgement of theAdministrator 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 may contactJames 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 mustmail your request for such a waiver to: James Hollins, Information Resources and ServicesDivision (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
3. Copies for the Docket . In addition to filing an objection orhearing request with the Hearing Clerk as described in Unit III.A., you should also send a copyof your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2.Mail your copies, identified by docket control number OPP-301023, to: PublicInformation and Records Integrity Branch, Information Resources and Services Division(7502C), Office of Pesticide Programs, Environmental Protection Agency,1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy tothe location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of yourrequest via e-mail to: opp-docket@epa.gov. Please use an ASCII file format andavoid the use of special characters and any form of encryption. Copies of electronic objectionsand hearing requests will also be accepted 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 electroniccopy of your 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 establishes time-limited tolerances under FFDCA section 408.The Office of Management and Budget (OMB) has exempted these types of actions from reviewunder Executive Order 12866, entitled Regulatory Planning and Review (58 FR51735, October 4, 1993). This final rule does not contain any information collections subject toOMB 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 ofthe Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does itrequire any prior consultation as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655,May 19, 1998); special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice 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 fromEnvironmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This actiondoes not involve any technical standards that would require Agency consideration of voluntaryconsensus standards pursuant to section 12(d) of the National Technology Transfer andAdvancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272note). Since tolerances and exemptions that are established on the basis of a FIFRA section 18petition under FFDCA section 408, such as the tolerances in this final rule, do not require theissuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C.601 et seq. ) do not apply. In addition, the Agency has determined that this actionwill not have a substantial direct effect on States, on the relationship between the nationalgovernment and the States, or on the distribution of power and responsibilities among the variouslevels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop anaccountable process to ensure "meaningful and timely input by State and local officials in thedevelopment of regulatory policies that have federalism implications." "Policies that havefederalism implications" is defined in the Executive Order to include regulations that have"substantial direct effects on the States, on the relationship between the national government andthe States, or on the distribution of power and responsibilities among the various levels ofgovernment." This final rule directly regulates growers, food processors, food handlers and foodretailers, not States. This action does not alter the relationships or distribution of power andresponsibilities established by Congress in the preemption provisions of FFDCA section408(n)(4).
V. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq. , as added bythe Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that beforea rule may take effect, the agency promulgating the rule must submit a rule report, whichincludes a copy of the rule, to each House of the Congress and to the Comptroller General of theUnited States. EPA will submit a report containing this rule and other required information tothe U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the UnitedStates prior to publication of this final rule in the Federal Register . This final ruleis 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, Agriculturalcommodities, Pesticides and pests, Reporting and recordkeeping requirements.
Dated: July 12, 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), 346(a) and 371.
§ 180.472 [Amended]
2. In § 180.472, amend the table in paragraph (b), by revising the expiration/revocation date for the following commodities: "Citrusfruits crop group," "Dried citrus pulp," "Legume vegetables" and "Strawberry" from "6/30/00" to read "6/30/02".
[FR Doc. 00-18908 Filed 7-25-00; 8:45 am]
BILLING CODE 6560-50-F