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benomyl (Benlate) Cancellation Order 7/01


ENVIRONMENTAL PROTECTION AGENCY

[OPP-66288; FRL-6794-9]


Benomyl; Cancellation Order

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY:  This notice announces a cancellation order for product
cancellations requested by E.I. du Pont de Nemours & Company (DuPont)
for its registrations of pesticide products containing methyl 1-
(butylcarbamoyl)-2-benzimidazole carbamate, or benomyl, and accepted by
EPA, pursuant to section 6(f) of the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA). This order follows up a May 23, 2001,
notice of receipt of requests for registration cancellations. In that
notice, EPA requested comments on the proposed cancellations and
indicated that it would issue an order confirming the voluntary
registration cancellations. Any distribution, sale, or use of canceled
benomyl products is only permitted in accordance with the terms of the
existing stocks provisions of this cancellation order.

DATES: The cancellations are effective August 8, 2001.

FOR FURTHER INFORMATION CONTACT: By mail: Demson Fuller, Special Review
and Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460, telephone number: (703) 308-8062; fax number:
(703) 308-7042; e-mail address: fuller.demson@epamail.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 benomyl 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/.
    2. In person. The Agency has established an official record for
this action under docket control number OPP-66288. 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 Request to Cancel Registrations

A. Background

    Benomyl is a benzimidazole carbamate and systemic foliar fungicide
registered for use on almonds, apples, anise, apricots, asparagus,
avocado, banana, barley, bean vine, blueberries, brassica (broccoli,
Brussels sprouts, cabbage, chicory, chinese cabbage, cauliflower,
collards, kale, kohlrabi, mustard greens, rutabagas, and turnips),
caneberries (raspberries, blackberries, boysenberries, loganberries,
and dewberries), cardoon, carrots, celery, cherries, citrus, conifers,
corn, cucurbits (cucumber, melons, pumpkins, and squash), currants,
dandelions, dill, figs, grapes, macadamia nuts, mangoes, mushrooms,
nectarines, onions, oats, papayas, peaches, peanuts, pears, peas,
pecans, peppers, pineapple, pistachio, plums, prunes, rape, rice, rye,
soybeans, spinach, strawberry, sugar beets, tomatoes, wheat, and yams.
    Dupont met with the Agency on April 18, 2001, and requested a
voluntary cancellation of all their registrations for
products containing benomyl, to be effective December 31, 2001. Dupont
stated that this decision was based on business reasons. They submitted
this request in writing in a letter dated April 18, 2001. On May 1,
2001, Dupont submitted a second letter requesting that the effective
date of cancellation be moved from December 31, 2001, to May 1, 2001.
EPA noted that it could not grant a cancellation request until the
requisite public comment period expired and EPA had considered public
comments received.
    Pursuant to section 6(f)(1) of the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA), EPA announced receipt of this request from
Dupont in a Federal Register notice published on May 23, 2001 (66 FR
28466) (FRL-6784-3). In that notice EPA provided a 30-day comment
period. Dupont requested that the Administrator waive the 180-day
comment period provided under FIFRA section 6(f)(1)(c), and EPA granted
this request.
    Public comments were received from seven interested parties:
    The American Mushroom Institute is concerned with the loss of
benomyl due to its effectiveness controlling diseases such as green
mold. They would like for the Agency to assist them in registering
effective alternatives.
    The Arizona Department of Agriculture would like for Dupont to
dispose of any benomyl products that dealers have in stock after the
proposed December 31, 2002, termination of sales date for products in
the channels of trade. They also have concerns for users who may have
excess benomyl and would like Dupont to dispose of their products as
well.
    The California Pistachio Commission is concerned with the timing
for tolerance revocation. They fear that growers may purchase excess
stocks of benomyl and not have adequate time to exhaust their benomyl
supplies and allow for treated pistachios to clear the channels of
trade before tolerances are revoked. They ask EPA to delay tolerance
revocation until 2007.
    A blueberry grower in Michigan, as well as the Michigan Blueberry
Growers Association, commented on the need for effective materials to
control diseases such as canker, botrytis, anthracnose, and alternaria
on blueberries. The Michigan Blueberry Growers Association is also
concerned over the timing for tolerance revocation.
    The U.S. Apple Association commented that growers of both apples
and pears will need new products to control various diseases currently
controlled by benomyl. They are concerned with the high costs
associated with certain benomyl alternatives, and that increased use of
less-expensive alternatives may lead to resistance problems. The U.S.
Apple Association also asks that EPA delay tolerance revocation for 4
years after cancellation to ensure apple products clear the channels of
trade.
    Finally, a consulting firm objected to Dupont's request to waive
the 180-day comment period because the unexpected request for
cancellation has the potential to cause financial loss to other
registrants working with, or preparing to work with benomyl. Because
``me-too'' applications for registrations of a generic off-patent
product require the active registration of a substantially similar
product, this firm holds that Dupont has eliminated the opportunity for
other registrants to apply for and obtain benomyl product ``me-too''
registrations. The effect of this, they say, is that generic
registrants will lose investments they may have made in pursuing such
registrations.
    In response to this last comment, EPA notes that FIFRA allows
applicants who have submitted their applications before the voluntary
cancellation has occurred to use the data submitted by the original
data submitter as long as data compensation requirements are fulfilled.
EPA acknowledges that Dupont's decision may affect the business
opportunities of other pesticide manufacturers who wish to register new
benomyl products, and that waiving the 180-day comment period reduces
the window of opportunity for submission of ``me-too'' applications for
registration. At the time Dupont requested the voluntary cancellations,
it had already ceased production of benomyl. FIFRA section 6(f)(1)(C)
states that EPA may waive the 180-day comment period upon the request
of the registrant. The Agency believes, that this provision was
intended to give ample time for EPA to hear from growers the potential
impact of the requested cancellations on agriculture. EPA, in
coordination with the U.S. Department of Agriculture, has communicated
with representatives of commodity groups for the crops on which benomyl
is registered to: Inform them of the requested cancellation, summarize
the Federal Register notice announcing the requested cancellation,
ascertain the potential impacts on Agriculture of the requested
cancellations, and encourage affected parties to submit comments during
the 30-day comment period on the proposed cancellations. For these
reasons, EPA decided that it was appropriate to grant Dupont's request
to waive the 180-day comment period as provided for by FIFRA section
6(f)(1)(C).
    In response to comments on the timing for tolerance revocation, EPA
is concerned with growers purchasing excess amounts of benomyl. Because
this action is not due to risk issues, EPA is not setting a last legal
use date, but, EPA believes that use of existing stocks of these
products will likely end in 2003, given that the registrant ceased
production of technical product around April 2001, and that no sale or
distribution of product may occur after December 31, 2002. EPA will
determine how long treated food containing residues of benomyl could
remain in the channels of trade assuming that treatment last occurs on
December 31, 2003, and will set the tolerance revocation dates
accordingly.
    In response to the comments on the need for reasonable disposal of
benomyl, EPA recommends that distributors purchase reasonable supplies
to avoid excess stocks. EPA notes that Dupont, in a letter dated July
6, 2001, has offered to receive product for the purpose of disposal
from dealers and distributors following December 31, 2002, and from
users following December 31, 2003. Dupont will dispose of these
products at no cost to anyone willing to ship the products to a
designated Dupont facility.
    In response to comments on the need for alternative materials to
replace benomyl, EPA is aware of the importance of benomyl to growers.
The Agency is committed to working with industry to identify and make
available suitable alternatives to control diseases on mushrooms,
blueberries, apples, pears, and other crops. Also, EPA continues to
expedite new fungicides through its reduced risk initiative which
shortens the time required to register new chemicals and uses.

B. Requests for Voluntary Cancellation of Products

    Pursuant to FIFRA section 6(f)(1)(A), Dupont has submitted requests
for voluntary cancellation of registrations for their products
containing benomyl. The registrations for which cancellations were
requested are identified in the following Table 1:


         Table 1. -- Product Registration Cancellation Requests
------------------------------------------------------------------------
             Company                    Reg. No             Product
------------------------------------------------------------------------
 E.I. du Pont de Nemours &        352-354             Dupont
 Company                                               Benlate
                                                       Fungicide

E.I. du Pont de Nemours &         352-377             Dupont Benomyl
 Company                                               Technical

E.I. du Pont de Nemours &         352-385             Dupont
 Company                                               Benlate
                                                       OD Fungicide

E.I. du Pont de Nemours &         352-564             Dupont
 Company                                               Benlate
                                                       SP Fungicide
------------------------------------------------------------------------


                          DuPont Special Local Need Registration Cancellation Requests
----------------------------------------------------------------------------------------------------------------
              SLN Number                         Crop Reg. No                  Product
----------------------------------------------------------------------------------------------------------------
AZ-930015                              Onions 352-354                  Dupont
Benlate
Fungicide

 VT-770005                              Apples 352-354                  Dupont
Benlate
Fungicide

WA-000009                              Asparagus Crowns 352-564                  Dupont
Benlate SP
Fungicide

WA-770040                              Asparagus Crowns 352-354                  Dupont
Benlate
Fungicide
----------------------------------------------------------------------------------------------------------------

III. Cancellation Order

    Pursuant to section 6(f)(1)(A) of FIFRA, EPA is approving the
requested registration cancellations. Accordingly, the Agency orders
that the registrations identified in Table 1, are hereby canceled. Any
distribution, sale, or use of existing stocks of the products
identified in Table 1, in a manner inconsistent with the terms of this
Order or the Existing Stock Provisions in Unit IV of this Federal
Register 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 Provisions

    For purposes of this Order, the term ``existing stocks'' is
defined, pursuant to EPA's existing stocks policy 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
cancellation.

A. Distribution or Sale by the Registrant

    The distribution or sale of existing stocks by registrants will not
be lawful under FIFRA after August 8, 2001, 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.

B. Distribution and Sale by Other Persons

    Sale or distribution by any person of existing stocks of any
products identified in Table 1, will not be lawful under FIFRA after
December 31, 2002.

V. Notification of Intent to Revoke Tolerances

    This notice also serves as an advance notification that the Agency
intends to revoke the related tolerances, for the cancelled
registrations listed in this notice, unless there is a request from the
public to support the tolerances for import purposes. EPA believes that
the end use of any remaining existing stocks of these products will
likely end in 2003 given that production of technical product by the
registrant ceased around April 2001 and that sale and distribution of
benomyl products will end on December 31, 2002. EPA will determine how
long treated food containing residues of benomyl could remain in the
channels of trade assuming that the last treatment occurred on December
31, 2003, and will set the expiration date accordingly.
    It is EPA's general practice to propose revocation of tolerances
for residues of pesticide active ingredients for which FIFRA
registrations no longer exist, to protect the food supply of the U.S.
and to discourage the misuse of pesticides within the United States. In
many cases the cancellation of a food use in the U.S. indicates that
there are insufficient domestic residue data or other information to
support the continuation of the tolerance and an uncertain amount of
relevant data concerning residues on imported food. In the absence of
relevant data, EPA is unable to make a safety finding regarding the
treated food entering the U.S. Upon request, EPA will provide
interested parties with its import tolerance policy and data
requirements, explaining how an interested party should go about
seeking to retain a tolerance for import purposes.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: July 23, 2001.

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

[FR Doc. 01-19572 Filed 8-7-01; 8:45 am]
BILLING CODE 6560-50-S