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vinclozolin (Ronilan) Notice of Use Cancellations 8/01


ENVIRONMENTAL PROTECTION AGENCY

[OPP-66290; FRL-6795-7]


Vinclozolin; Notice of Use Cancellations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces use cancellations as requested by BASF
Corporation for its registrations containing 3-(3,5-dichlorophenyl)-5-
ethenyl-5-methyl-2,4-oxazolidinedione), or vinclozolin, pursuant to
section 6(f) of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA). This Notice follows up a September 20, 2000, Notice of receipt
of requests to delete these uses from vinclozolin registrations, and to
terminate use and sale for these uses by certain dates. This Notice
also requested comments on these use deletions and dates for end of
sale and use. EPA has considered the comments received and has modified
the schedule of end of sale and use dates accordingly. Any
distribution, sale, or use of the products subject to this cancellation
order is only permitted in accordance with the terms of the existing
stocks provisions of this cancellation order.

DATES: The cancellations are effective August 22, 2001.

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; fax number:
(703) 308-7042; e-mail address: scher.deanna@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. You may be
potentially affected by this action if you manufacture, sell,
distribute, or use vinclozolin products. The Congressional Review Act,
5 U.S.C. 801 et seq., as added by the Small Business Regulatory
Enforcement Fairness Act of 1996, does not apply because this action is
not a rule, for purposes of 5 U.S.C. 804(3). Since other entities may
also be interested, 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 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 Other Related Documents?

    1. 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/. To access information about the risk
assessment and Reregistration Eligibility Decision for vinclozolin, go
to the Home Page for the Office of Pesticide Programs, or go directly
to http://www.epa.gov/pesticides/reregistration/vinclozolin/.
    2. In person. The Agency has established an official record for
this action under docket control number OPP-66290. The official record
consists of the documents specifically referenced in this action, any
public comments received during an applicable comment period, and other
information related to this action, including any information claimed
as Confidential Business Information (CBI). This official record
includes the documents that are physically located in the docket, as
well as the documents that are referenced in
those documents. The public version of the official record does not
include any information claimed as CBI. The public version of the
official record, which includes printed, paper versions of any
electronic comments submitted during an applicable comment period, 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. Receipt of Requests to Amend Registrations to Delete Uses

A. Background

    Vinclozolin (trade names Curalan, 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 various agricultural crops, ornamental plants, and turf.
BASF, the technical 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 (April 21, 2000, 65 FR 21427) (FRL-6555-6).
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
dietary risks of concern, the Agency identified risk concerns for
occupational workers in the ornamental industry in part due to the
potential for long-term exposure and a risk of concern for children
playing on transplanted sod previously treated on a sod farm.
    Therefore, 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, on
May 31, 2000 BASF requested the immediate voluntary cancellation of use
on raspberries onions and ornamentals, phase-out over the following 4
years of all other domestic food uses of vinclozolin except canola, and
the revocation of all import tolerances except for wine grapes to
permit the importation of wine containing residues of vinclozolin. BASF
also requested that EPA modify use of vinclozolin on turf. The
cancellations 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.
    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)(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
requested that EPA waive the 180-day comment period. In light of this
request, EPA granted the request to waive the 180-day comment period,
and a 30-day comment period was allowed.
    EPA announced these use cancellation and amendment requests in a
Federal Register Notice (September 20, 2000, 65 FR 56894) (FRL-6744-2)
and asked for public comments. In response, public comments were
received from three interested parties. The Scotts Company remarked
that it will be difficult for distributers and retailers to manage
inventory based on the Agency's proposed last legal use date being
concurrent with the last date for sale and distribution. Scotts also
requested that the last legal use date be extended for ornamentals
based on the difficulties associated with canceling use during the
middle of the normal use period for one of the largest ornamental
markets. The National Onion Association expressed concern that
alternatives to vinclozolin may be more costly and less effective. The
Association also argued that registration of newer, safer alternatives
should be expedited and that growers in foreign countries could use
vinclozolin on onions for export to the U.S. and thereby gain an unfair
advantage over U.S. growers. Weyerhaeuser Corporation argued against
the use cancellation of vinclozolin for forestry seedlings grown in
greenhouses and nurseries based on convincing evidence that there is a
lack of alternatives for this use. Weyerhaeuser also provided
information about the handler and re-entry exposure and use practices
for coniferous forest tree species in greenhouses.
    Reviewing and responding to the comments and additional information
submitted by Weyerhaeuser required substantial resources and time.
Consequently, the dates originally proposed for ``last date for sale
and distribution of existing stocks'' for onions, raspberries, and
ornamentals have passed. In order to obviate any confusion or
difficulty this may cause those entities affected by this action, the
last date for sale and distribution of existing stocks for onions
raspberries, and ornamentals has been extended from January 1, 2001 to
August 30, 2001.
    In response to comments provided by the Scotts Company, EPA has
amended the previously proposed time frames by designating separate
dates for sale and distribution and for last legal use. Although this
amendment slightly extends the time frames for last legal use, the
change is considered minimal as the new dates do not exceed 2 or 3
months past the original dates established for last legal use. In
addition, the extension of the last sale dates for the product bearing
the ornamentals use until October 15, 2001 will also address Scott's
concerns by allowing sales through the end of the seasonal use period
as defined by Scotts.
    In response to National Onion Association comments, EPA is also
concerned about the availability of alternatives to vinclozolin but
believes there are less risky fungicides available. EPA also continues
to expedite new fungicides through its Reduced-Risk Initiative, which
significantly shortens the time required to register commercially
viable alternatives to pesticides with risks of concern, and is
currently working on registration of a vinclozolin alternative through
this effort. Also, while foreign growers may use vinclozolin in the
near term on onions for export into the U.S., EPA intends to propose
revocation of tolerances for vinclozolin on all canceled uses as soon
as it can be reasonably expected that domestic use has ceased (i.e.,
the last legal use date has passed). Revocation of tolerances will make
the importation of such vinclozolin treated commodities unlawful. In
accordance with FFDCA section 408(l)(2), EPA will revoke the tolerances
within 180 days of last legal use. 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).
    Finally, to address the concerns raised by Weyerhaeuser, EPA is
allowing the sale, distribution, and use of vinclozolin on coniferous
forestry seedlings for an additional 2 years. However to mitigate risks
to re-entry workers, a 12-day restricted entry interval will be
required. However, EPA will allow exceptions to the restricted entry
 interval after 3 days for irrigation and after 7 days for weeding and
scouting. These use changes have been made to the Curalan EG
formulation (EPA Reg. No. 7969-85) as a supplemental label for this
registration. The supplemental label will allow use until August 30,
2003.

B. Requests for Voluntary Amendment and Cancellation

    Pursuant to FIFRA section 6(f)(1)(A), BASF submitted requests for
voluntary cancellation and use amendment of 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.
    EPA has considered the public comments received as detailed above
in section II.A. and the timing of this Notice, and has modified the
time frames for use cancellation and existing stocks from that
published in the original proposal. These changes are reflected in the
following Table 1.

                     Table 1.--Time Frame for Use Cancellation and Existing Stocks Provision
----------------------------------------------------------------------------------------------------------------
                                                      Last Date for Sale  Last Date for Sale
                                  Date of Registrant   and Distribution    and Distribution      Last Date for
            Commodity              Use Cancellation   of Existing Stocks  of Existing Stocks       Legal Use
                                        Request          by Registrant         by Others
----------------------------------------------------------------------------------------------------------------
Onions                            July 15, 2000       August 30, 2001 October 15, 2001    December 15, 2001
----------------------------------------------------------------------------------------------------------------
Raspberries                       July 15, 2000       August 30, 2001 October 15, 2001    December 15, 2001
----------------------------------------------------------------------------------------------------------------
Ornamentals (except conifer       July 15, 2000       August 30, 2001 October 15, 2001    December 15, 2001
 seedlings)
----------------------------------------------------------------------------------------------------------------
Conifer seedlings                 July 15, 2000       August 30, 2003 October 15, 2003    December 15, 2003
----------------------------------------------------------------------------------------------------------------
Kiwi                              December 31, 2001   December 31, 2002   November 30, 2003   January 30, 2004
----------------------------------------------------------------------------------------------------------------
Chicory                           December 31, 2001   December 31, 2002   November 30, 2003   January 30, 2004
----------------------------------------------------------------------------------------------------------------
Lettuce                           July 15, 2004       July 15, 2005 September 30, 2005  November 30, 2005
----------------------------------------------------------------------------------------------------------------
Succulent Beans                   July 15, 2004       July 15, 2005 September 30, 2005  November 30, 2005
----------------------------------------------------------------------------------------------------------------

III. Cancellation Order

    Pursuant to FIFRA section 6(f)(1)(A), EPA hereby grants the
requested voluntary use cancellations and amendments of the
registrations for vinclozolin as described in this Notice. Accordingly
any distribution, sale, or use of existing stocks of in a manner
inconsistent with the terms of this Order or the Existing Stock
Provisions in Unit IV of this Notice will be considered a violation of
section 12(a)(2)(K) of FIFRA and/or section 12(a)(1)(A) of FIFRA.

IV. Existing Stocks Provision

    Pursuant to section 6(f) of FIFRA, EPA is granting the requests for
voluntary amendment and cancellation during the appropriate time frames
identified in Table 1. For purposes of the cancellation order, the term
``existing stocks'' will be defined, pursuant to EPA's existing stocks
policy at (June 26, 1991, 56 FR 29362) (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 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.
    The distribution or sale of existing stocks by registrants will not
be lawful under FIFRA after the sale and distribution dates for
registrants 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. Retailers
and distributors may sell or distribute products with previously
approved labeling which have been released for shipment until such
supplies are exhausted, or until the date specified for ``Sale and
Distribution by Others'' as presented Table 1, whichever comes first.
End-users may use products with previously approved labeling until such
supplies are exhausted or until the last legal use date listed in Table
1, whichever comes first.

List of Subjects

    Environmental protection, Pesticides and pests.


    Dated: August 10, 2001.
Jack E. Housenger,
Acting Director, Special Review and Reregistration Division, Office of
Pesticide Programs.

[FR Doc. 01-21200 Filed 8-21-01; 8:45 am]