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vinclozolin (Ronilan) Voluntary Termination of Uses 7/98

[Federal Register: July 30, 1998 (Volume 63, Number 146)]
[Page 40710-40712]
>From the Federal Register Online via GPO Access []



[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- 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:

I. 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 filed in 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.

II. 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.

III. 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 

IV. 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.

V. Proposed Acceptance of Use Termination and Existing Stocks 

    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.

VI. 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

[[Page 40712]]

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.

VII. 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:

    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 filed online 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. 98-20410 Filed 7-29-98; 8:45 am]