Pesticide registration, cancellation, etc.: Vinclozolin,

[Federal Register: September 20, 2000 (Volume 65, Number 183)]

[Notices]

[Page 56894-56895]

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

[DOCID:fr20se00-75]

ENVIRONMENTAL PROTECTION AGENCY

[OPP-64051; FRL-6744-2]

Vinclozolin; Receipt of Request For Amendments to Delete Uses

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

SUMMARY: In accordance with section 6(f)(1) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 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. The requests to cancel certain uses from the registrations are intended to mitigate dietary and aggregate risks which exceed the Agency's level of concern. EPA will decide whether to approve the requests after consideration of public comment.

DATES: Comments on the requested amendments to delete uses must be submitted to the address provided below by October 20, 2000.

FOR FURTHER INFORMATION CONTACT: By mail: Deanna Scher, Special Review and Reregistration Division (7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 308-7043; e-mail address: scher. deanna@epa.gov.

SUPPLEMENTARY INFORMATION:

1. General Information

   1. Does this Action Apply to Me?

      This action is directed to the public in general. Although this action may be of particular interest to persons who produce or use pesticides, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the information in this notice, consult the person listed under FOR FURTHER INFORMATION CONTACT.

   2. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?

      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 Register--Environmental Documents.'' You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/.

2. BASF Request to Amend Registrations

   1. Background Information

      Vinclozolin (trade names Curalan, Ronilan, Vorlan, and Touche) is a fungicide first registered in 1981 to control various types of rot cause by Botrytis spp., Sclerotinia spp, and other types of mold and blight causing organisms on lettuce, onions, raspberries, succulent beans, canola, kiwi, chicory grown for endive, and turf on golf courses, commercial sites, and industrial sites. Vinclozolin is also registered for use on ornamental plants in greenhouses and nurseries.

      BASF, the sole registrant of vinclozolin, petitioned EPA to establish tolerances for residues of the fungicide vinclozolin and its metabolites containing the 3,5-dichloroanaline moiety in or on canola and succulent beans (65 FR 21427, April 21, 2000) (FRL-6555-6). Concomitantly, BASF also proposed amendments under section 3 of FIFRA to the label for Ronilan fungicide (EPA Reg. No. 7969-85) to add the use of these crops. However, EPA was unable to make the ``reasonable certainty of no harm'' finding mandated by section 408(b)(2) of the Federal Food, Drug, and Cosmetic Act (FFDCA) for succulent beans and canola use and associated tolerances if all existing uses remained in place.

      In addition to the action on the tolerance petition, EPA has been working to make a reregistration decision under FIFRA concerning vinclozolin and plans to release a Reregistration Eligibility Decision shortly. As part of the reregistration process, the Agency has recently identified risk concerns for occupational workers in the ornamental industry in part due to the potential for long-term exposure. The Agency also identified a risk of concern for children playing on transplanted sod previously treated on a sod farm.

   2. Request for Voluntary Cancellation

      To reduce the risk posed by exposure to vinclozolin, and thereby enable the Agency to make a ``reasonable certainty of no harm'' finding for succulent beans and canola and the related tolerances, BASF requested the immediate voluntary cancellation of some registered uses. In addition, BASF requested a phase-out over the next 4 years of all domestic food uses of vinclozolin except for the use on canola, and the revocation of all import tolerances except for wine grapes to permit the importation of treated wine. BASF also requested that EPA delete the use of vinclozolin on ornamentals and modify use of vinclozolin on turf.

      On May 31, 2000, BASF submitted a written request to EPA seeking to amend the registrations for vinclozolin. Specifically, BASF requested that EPA immediately amend registration number 7969-85 (Ronilan, Curalan, Touche) to terminate the use of vinclozolin on onions, raspberries, and ornamental plants. The product Vorlan (sold under EPA registration number 7969-85) would no longer be available, as this product is for use on ornamentals only. BASF made clear that the proposed use terminations were conditioned on EPA reestablishing the expired tolerance for vinclozolin use on succulent beans and granting a new tolerance associated with a canola registration. The cancellations were also conditioned on EPA accepting certain existing stock provisions. BASF requested that EPA waive the 180-day waiting period for EPA action on its use termination requests.

      Under section 6(f)(1)(A) of FIFRA, registrants may request, at any time, that their pesticide registrations be amended to delete one or more pesticide uses. Section 6(f)(1)(B) of FIFRA requires that EPA provide a 30-day comment period on the request for voluntary cancellation. In addition, section

      [[Page 56895]]

      6(f)(1)(C) of FIFRA requires that EPA provide a 180-day comment period on a request for voluntary termination of any minor agricultural use before granting the request, unless the registrants request a waiver of the comment period, or the Administrator determines that continued use of the pesticide would pose an unreasonable adverse effect on the environment. The registrant has requested that EPA waive the 180-day comment period. In light of this request, EPA is granting the request to waive the 180-day comment period.

      The following Table 1 specifies the time frame for the immediate cancellation and phase-out of several uses as requested by BASF. Commodities legally treated will be allowed in the channels of trade past the last date of legal use in accordance with FFDCA section 408(l)(5).

      Table 1. -- Time Frame for Use Cancellation and Proposed Existing Stocks Provision

      Last Date for Sale and Commodity

      Date of Use

      Distribution of Last Date for Legal Use Cancellation Request Existing Stocks

      Onions

      July 15, 2000

      January 1, 2001

      September 30, 2001

      Raspberries

      July 15, 2000

      January 1, 2001

      September 30, 2001

      Ornamentals

      July 15, 2000

      July 15, 2001

      September 1, 2001

      Kiwi 24(c)

      December 31, 2001* December 31, 2002

      November 30, 2003

      Chicory 24(c)

      December 31, 2001* December 31, 2002

      November 30, 2003

      Lettuce

      July 15, 2004

      July 15, 2005

      September 30, 2005

      Succulent beans

      July 15, 2004

      July 15, 2005

      September 30, 2005

      * BASF will inform the State of California that it can no longer support the 24(c) registrations by this date.

3. What is the Agency's Authority for Taking this Action?

   Section 6(f)(1) of FIFRA provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be canceled. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the Federal Register. Thereafter, the Administrator may approve such a request.

4. Procedures for Withdrawal of Request

   Registrants who choose to withdraw a request for cancellation must submit such withdrawal in writing to the person listed under FOR FURTHER INFORMATION CONTACT, postmarked before October 20, 2000. This written withdrawal of the request for cancellation will apply only to the applicable FIFRA section 6(f)(1) request listed in this notice. If the product(s) have been subject to a previous cancellation action, the effective date of cancellation and all other provisions of any earlier cancellation action are controlling. The withdrawal request must also include a commitment to pay any reregistration fees due, and to fulfill any applicable unsatisfied data requirements.

5. Proposed Existing Stocks Provision

   Pursuant to section 6(f) of FIFRA, EPA proposes to grant the requests for voluntary amendment and cancellation during the appropriate time frames identified in Table 1. For purposes of the cancellation order that the Agency proposes to issue at the close of the comment period for this announcement, the term ``existing stocks'' will be defined, pursuant to EPA's existing stocks policy at (56 FR 29362, June 26, 1991) (FRL 3846-4), as those stocks of a registered pesticide product which are currently in the United States and which have been packaged, labeled, and released for shipment prior to the effective date of the amendment or cancellation. Any distribution, sale, or use of existing stocks after the effective date of the cancellation order that the Agency intends to issue that is not consistent with the terms of that order will be considered a violation of section 12(a)(2)(K) and/or 12(a)(1)(A) of FIFRA.

   1. Distribution or Sale by Registrants

      If the requested use deletions are approved, the distribution or sale of such stocks by registrants will not be lawful under FIFRA after the sale and distribution dates listed in Table 1, except for the purposes of returns and relabeling, shipping such stocks for export consistent with the requirements of section 17 of FIFRA, or for proper disposal.

   2. Distribution, Sale and Use by Other Persons

      If the requested use deletions are approved, retailers, distributors, and end-users may sell, distribute, or use products with previously approved labeling which have been released for shipment until such supplies are exhausted or the last legal use date presented in Table 1.

      List of Subjects

      Environmental protection, Agricultural commodities, Pesticides and pests.

      Dated: September 7, 2000.

      Lois Rossi, Director, Special Review and Reregistration Division, Office of Pesticide Programs.

      [FR Doc. 00-23941Filed9-19-00]

      BILLING CODE 6560-50-S