[Federal Register Volume 66, Number 163 (Wednesday, August 22, 2001)]
[Notices]
[Pages 44134-44136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-21200]


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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: [email protected].

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

[[Page 44135]]

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

[[Page 44136]]

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
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                                                      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
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Onions                            July 15, 2000       August 30, 2001     October 15, 2001    December 15, 2001
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Raspberries                       July 15, 2000       August 30, 2001     October 15, 2001    December 15, 2001
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Ornamentals (except conifer       July 15, 2000       August 30, 2001     October 15, 2001    December 15, 2001
 seedlings)
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Conifer seedlings                 July 15, 2000       August 30, 2003     October 15, 2003    December 15, 2003
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Kiwi                              December 31, 2001   December 31, 2002   November 30, 2003   January 30, 2004
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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]
BILLING CODE 6560-50-S