vinclozolin (Ronilan) Voluntary Termination of Uses 7/98
[Federal Register: July 30, 1998 (Volume 63, Number 146)]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
ENVIRONMENTAL PROTECTION AGENCY
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-
email@example.com. 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
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
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
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
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
[FR Doc. 98-20410 Filed 7-29-98; 8:45 am]
BILLING CODE 6560-50-F