Pesticide registration, cancellation, etc.: Vinclozolin,

[Federal Register: July 30, 1998 (Volume 63, Number 146)]

[Notices]

[Page 40710-40712]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr30jy98-59]

ENVIRONMENTAL PROTECTION AGENCY

[OPP-66257; FRL-6020-9]

Vinclozolin; Voluntary Termination of Uses

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of receipt of request to terminate uses.

Summary: In accordance with section 6(f)(1) of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended, EPA is issuing a notice of receipt of request by BASF Corporation to amend its registrations for products containing 3-(3,5-dichlorophenyl)-5-ethenyl-5-methyl-2,4- oxazolidinedione), or vinclozolin, to terminate certain uses.

DATES: Comments must be submitted on or before August 31, 1998.

ADDRESSES: By mail, submit written comments to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. In person, deliver comments to: Rm. 119, CM #2, 1921 Jefferson Davis Highway, Arlington, VA.

Comments and data may also be submitted electronically to: opp- docket@epamail.epa.gov. Follow the instructions under Unit VII. of this document. No Confidential Business Information (CBI) should be submitted through e-mail.

Information submitted as a comment concerning this document may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the comment that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential will be included in the public docket by EPA without prior notice. The public docket is available for public inspection in Rm. 119 at the Virginia address given above, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: Mark Wilhite, Reregistration Branch I (7508W), Special Review and Reregistration Division, Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20046. Office location, telephone number, and e-mail address: Reregistration Branch I, 3rd Floor, 2800 Crystal Drive, Arlington, VA; (703) 308-8586, and e-mail: wilhite.mark@epamail.epa.gov. SUPPLEMENTARY INFORMATION:

1. Background Information

   Vinclozolin (trade names Curalan, Ornilan, and Ronilan) is a fungicide first registered in 1981 to control various types of rot caused by Botrytis spp., Sclerotinia spp, and other types of mold and blight causing organisms on lettuce (all types), onions, raspberries, stonefruit, strawberries, succulent beans, tomatoes, and turf on golf courses, commercial sites, and industrial sites. Vinclozolin is also registered for use on ornamental plants in greenhouses and nurseries. During its review of the vinclozolin toxicology data base for the purpose of making a decision concerning reregistration of vinclozolin under the Federal Insecticide, Fungicide, and Rodenticide Act (``FIFRA''), EPA decided an additional tenfold margin of safety, as specified in the Food Quality Protection Act of 1996, was required to protect the safety of infants and children. Given prior EPA risk assessments of the acute risk posed by vinclozolin, that use of the additional tenfold margin of safety would render aggregate exposure to vinclozolin under existing use patterns to be unacceptably high. BASF, the sole registrant of vinclozolin used on food commodities, recently requested amendment of its vinclozolin registrations to terminate two uses of vinclozolin in order to mitigate this risk.

   There are several ongoing actions concerning vinclozolin. First, as mentioned above, EPA has been working to make a reregistration decision under FIFRA concerning vinclozolin. EPA plans to release a Reregistration Eligibility Decision in the next few months. Second, objections and hearing requests were filedin regard to EPA's establishment of a tolerance for vinclozolin on succulent beans published in the Federal Register of July 18, l997 (62 FR 38464) (FRL- 5727-9). EPA anticipates issuing a decision on the hearing requests and objections, as appropriate, shortly. EPA has made no final decision regarding the eligibility of vinclozolin for reregistration or as to the hearing requests or objections.

2. BASF Request to Amend Registrations

   On June 30, 1998, BASF submitted a written request to EPA seeking to amend the registrations for vinclozolin. Specifically, BASF requested that EPA amend registration numbers 7969-53, 7969-57, 7969- 62, and 7969-85 to terminate the use of vinclozolin on

   [[Page 40711]]

   stone fruits and strawberries. BASF requested that EPA waive the 180- day waiting period for EPA action on its use termination request.

   BASF made clear that the proposed use terminations were conditioned on EPA accepting certain existing stock provisions. EPA interprets BASF's request as proposing the following existing stock provisions:

   1. All existing stocks released for shipment by BASF prior to August 30, 1998, shall be available for sale to end users until June 30, 1999.

   2. Beginning on August 30, 1998, BASF will sticker all cases of vinclozolin-containing products (that are not yet palletted and are in BASF's site of manufacturing/packaging and contain the old labeling) with a notice barring sale and use of the products on the terminated sites after June 30, 1999.

   3. Within 30 days of EPA approval of BASF's proposed use terminations and existing stock provisions, BASF will provide to all Ronilan points of purchase (shown by EDI sales to resellers) 50 copies (per location) of a bulletin with the pertinent details of the label amendments and the existing stocks provisions.

   4. Use of vinclozolin on terminated use sites will be prohibited after January 30, 2000. BASF also made several requests regarding the timing of the revocation of Federal Food, Drug, and Cosmetic Act (FFDCA) tolerances associated with the terminated uses, the FFDCA provision addressing commodities in the channels of trade following FIFRA cancellation and FFDCA revocation, and FIFRA recall or recovery provisions.

3. Terminations Pursuant to Voluntary Requests

   Under section 6(f)(1) of FIFRA, registrants may request at any time that ``a pesticide registration of the registrant be canceled or amended to terminate one or more pesticide uses'' (7 U.S.C. 136d(f)(1)). Consistent with section 6(f)(1) of FIFRA, EPA is issuing a notice of receipt of the request and allowing 30 days for public comment.

4. Procedures for Withdrawal of Request

   For BASF to withdraw a request for use termination BASF must submit such withdrawal in writing to Mark Wilhite, at the address listed under ``FOR FURTHER INFORMATION CONTACT,'' postmarked before August 31, 1998. This written withdrawal of the request for use termination will apply only to the applicable section 6(f)(1) request listed in this notice.

5. Proposed Acceptance of Use Termination and Existing Stocks Provision

   EPA proposes to accept BASF's request for amendment of its vinclozolin registration (EPA registration numbers 7969-53, 7969-57, 7969-62, and 7969-85) to terminate uses on stone fruits and strawberries. It is EPA's general practice to accept, as a routine matter, registrants requests for cancellation of registrations or specific uses in registrations unless the registrant withdraws the request. Notice of the request for cancellation is published primarily for the purpose of alerting affected parties so that they may either attempt to convince the registrant to maintain the registration or apply to register the product themselves. EPA proposes to approve these terminations expeditiously after the close of the comment period unless BASF withdraws its request or a compelling reason opposing termination is presented in public comments.

   EPA also proposes to accept BASF's requested existing stocks provisions. Under FIFRA section 6(a)(1), EPA may permit the continued sale and use of a canceled pesticide if such sale or use ``is not inconsistent with the purposes of this Act.'' BASF has made clear that its request for voluntary termination of these uses is tied to its proposal for existing stocks. Given EPA's risk concerns regarding vinclozolin, the Agency believes that generally any voluntary termination and existing stocks provision that results in less use of vinclozolin is not inconsistent with the provisions of FIFRA. By accepting this voluntary termination and existing stocks provision, EPA is not determining that exposure to vinclozolin under the revised registration and the existing stocks provision does not result in unreasonable adverse effects on the environment as that phrase is defined in FIFRA section 2(bb). Rather, EPA believes it has the flexibility to accept voluntary risk mitigation measures undertaken by registrants without first determining whether further actions are necessary to meet FIFRA standards. Ultimately, EPA must determine whether the vinclozolin registration meets FIFRA's unreasonable adverse effects standard. EPA will be making that determination shortly in the context of its reregistration decision on vinclozolin. Assuming BASF's request is approved, EPA will consider the vinclozolin registration, as amended, including the existing stocks provision, in making its determination on reregistration.

6. Proposed Existing Stocks Provision

   EPA proposes the following existing stocks provision:

   1. Effective no later than the date upon which the requested termination is approved (``approval date''), no vinclozolin products may be released for shipment unless their labels reflect the changes described in this notice.

   2. Any vinclozolin product that on the approval date: has not been released for shipment; is present in a BASF manufacturing or packaging facility; and contains labeling not reflecting the proposed terminations may be stickered by BASF to reflect the use terminations and to bar the sale and use by June 30, 1999.

   3. Retailers, distributors, and end-users may sell, distribute, or use products with the previously approved labeling which have already been released for shipment as of August 30, 1998, until such supplies are exhausted or January 30, 2000, whichever comes first.

   4. Within 30 days of the approval date, BASF shall provide to all Ronilan points of purchase, 50 copies of a bulletin with the pertinent details of the label amendments and existing stocks provisions. EPA requests public comment on these proposed existing stock provisions. EPA particularly asks for comment from parties affected by the restriction on use of the product after January 30, 2000.

   BASF requested that EPA revoke the tolerances for vinclozolin on strawberries and stone fruits on January 30, 2000. In response, EPA would note that it is EPA's general practice to revoke tolerances for canceled uses when existing stocks for such uses are exhausted or use is barred. BASF also sought confirmation that stone fruits and strawberries legally treated with vinclozolin prior to any tolerance revocation would be allowed to clear the channels of trade under FFDCA section 408(l)(5). Under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on a commodity after the date the tolerance is revoked will not be unlawful if the pesticide is applied when the tolerance was in effect and in a manner that was lawful under FIFRA and EPA has not issued a determination that consumption of the food will pose an unreasonable dietary risk. Additionally, BASF wanted clarification that it would have no obligation to recover or recall any vinclozolin products as a result of its voluntary termination request. In response, EPA would note that recalls under FIFRA section 19(b) are

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   mandatory only where a pesticide's registration has been suspended and canceled. Finally, BASF requested EPA provide advance public notice of its voluntary cancellation proposal. This notice provides the public with such notice. EPA will also publish the existing stocks provisions that are established if the requested termination is approved.

7. Public Record and Electronic Submissions

   The official record for this action, as well as the public version, has been established for this action under docket control number ``OPP- 66257'' (including comments and data submitted electronically as described below). A public version of this record, including printed, paper versions of electronic comments, which does not include any information claimed as CBI, is available for inspection from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The official record is located at the Virginia address in ``ADDRESSES'' at the beginning of this document.

   Electronic comments can be sent directly to EPA at:

   opp-docket@epamail.epa.gov

   Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comment and data will also be accepted on disks in Wordperfect 5.1/6.1 or ASCII file format. All comments and data in electronic form must be identified by the docket control number ``OPP-66257.'' Electronic comments on this action may be filedonline at many Federal Depository Libraries.

   List of Subjects

   Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests.

   Dated: July 23, 1998. Jack E. Housenger, Director, Special Review and Reregistration Division, Office of Pesticide Programs.

   [FR Doc. 98-20410Filed7-29-98; 8:45 am]

   BILLING CODE 6560-50-F