Formetanate Hydrochloride; Receipt of Requests to Voluntarily Delete Uses, Request for Cancellation, and Advance Notification of Tolerance Revocation

Note: EPA no longer updates this information, but it may be useful as a reference or resource.
 [Federal Register: February 8, 2000 (Volume 65, Number 26)]
[Notices]
[Page 6208-6211]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08fe00-82]

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ENVIRONMENTAL PROTECTION AGENCY

[OPP-64046; FRL-6489-6]


Formetanate Hydrochloride; Receipt of Requests to Voluntarily
Delete Uses, Request for Cancellation, and Advance Notification of
Tolerance Revocation

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Notice.

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SUMMARY:  AgrEvo USA Company, the company that holds the
pesticideregistration of pesticide products containing formetanate
hydrochloride (m-[[(dimethylamino)methylene]amino]phenyl
methylcarbamate hydrochloride) has asked EPA toamend its registration
to delete use on plums, prunes, and greenhouse grown ornamental
plants,and cancel six pesticide products registered for greenhouse
grown ornamental plants undersection 24(c) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA). In accordancewith section
6(f)(1) of FIFRA, as amended, EPA is issuing a notice of receipt of
this request bythe registrant. The request to delete the aforementioned
uses from the registration, and voluntarycancellation of 24(c)
registrations for greenhouse grown ornamental plants are the result of
anagreement between EPA and the registrant regarding the registration
of pesticide productscontaining formetanate hydrochloride. Given the
potential dietary risks from formetanatehydrochloride use on registered
food crops, the registrant requested, among other things, thatuses that
appear to be of little benefit (i.e., plums and prunes) be deleted from
pesticide productlabels. In addition, due to potential worker exposure
risks from formetanate hydrochloridepesticide product use on greenhouse
grown ornamental plants, the registrant requested that thisuse also be
terminated and registrations for this use under section 24(c) of FIFRA
be canceled.Following publication of this Notice and completion of a
30-day public comment period, EPAintends to grant the requested
amendments to delete uses and voluntary registration cancellations.

DATES:  Comments on the requested amendments to delete uses
andvoluntary registration cancellations must be submitted to the
address provided below by March 9, 2000.

FOR FURTHER INFORMATION CONTACT:  By mail: Michael Goodis,
SpecialReview and Reregistration Division (7508C), Office of Pesticide
Programs, EnvironmentalProtection Agency, 1200 Pennsylvania Avenue, NW,
Washington, DC 20460; telephone (703)308-8157; e-mail address:
goodis.michael@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
potentially be affected by thisaction if you manufacture, sell,
distribute, or use pesticide products containing the active

[[Page 6209]]

ingredient formetanate hydrochloride. Formetanate hydrochloride, trade
name is Carzol SP, isan insecticide/miticide of the carbamate
class, and is presently registered in the United States andis used on
citrus, stone and pome fruits, alfalfa (grown for seed), and greenhouse
grownornamental plants. AgrEvo USA Company is the sole technical
manufacturer of formetanatehydrochloride.
    Although this action may be of particular interest to persons who
produce or usepesticides, the Agency has not attempted to describe all
the specific entities that may be affectedby this action. If you have
any questions regarding the information in this notice, consult
theperson listed under ``FOR FURTHER INFORMATION CONTACT.''

B. How Can I Get Additional Information, Including Copies of this
Document and OtherRelated Documents?

    Electronically. You may obtain electronic copies of this
document,and certain other related documents that might be available
electronically, from the EPA InternetHome Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Lawsand
Regulations'' and then look up the entry for this document under the ``
FederalRegister--Environmental Documents.'' You can also go directly to
the FederalRegister listings at http://www.epa.gov/fedrgstr/.
    In Person. The Agency has established an official record for this
action under docketcontrol number OPP-64046. The official record
consists of thedocuments specifically referenced in this action, any
public comments received during anapplicable comment period, and other
information related to this action, including anyinformation claimed as
confidential business information (CBI). This official record includes
thedocuments that are physically located in the docket, as well as the
documents that are referencedin those documents. The public version of
the official record does not include any informationclaimed as CBI. The
public version of the official record, which includes printed, paper
versionsof any electronic comments submitted during an applicable
comment period, is available forinspection in the Public Information
and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Hwys, Arlington, VA, from 8:30 a.m. to 4 p.m.,
Mondaythrough Friday, excluding legal holidays. The PIRIB telephone
number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or
electronically. To ensureproper receipt by EPA, it is imperative that
you identify docket control number OPP-64046 in the subject line on the
first page of your response.
    By mail. Submit your comments to: Public Information and Records
Integrity Branch(PIRIB), Information Resources and Services Division
(7502C), Office of Pesticide Programs(OPP), Environmental Protection
Agency, 1200 Pennsylvania Avenue, NW, Washington, DC20460.
    In person or by courier. Deliver your comments to: Public
Information and RecordsIntegrity Branch (PIRIB), Information Resources
and Services Division (7502C), Office ofPesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall #2,
1921Jefferson Davis Hwys, Arlington, VA. The PIRIB is open from 8 a.m.
to 4 p.m., Mondaythrough Friday, excluding legal holidays. The PIRIB
telephone number is (703) 305-5805.
    Electronically. You may submit your comments electronically by E-
mail to:``opp-docket@epa.gov,'' or you can submit a computer disk as
described above. Do not submitany information electronically that you
consider to be CBI. Avoid the use of special charactersand any form of
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 orASCII file format. All comments in electronic form must be
identified by the docket controlnumber OPP-64046. Electronic comments
may also be filed online at manyFederal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to
be CBI. You mayclaim information that you submit to EPA in response to
this document as CBI by marking anypart or all of that information as
CBI. Information so marked will not be disclosed except inaccordance
with procedures set forth in 40 CFR part 2. In addition to one complete
version ofthe comment that includes any information claimed as CBI, a
copy of the comment that does notcontain the information claimed as CBI
must be submitted for inclusion in the public version ofthe official
record. Information not marked confidential will be included in the
public version ofthe official record without prior notice. If you have
any questions about CBI or the proceduresfor claiming CBI, please
consult the person identified in the ``FOR FURTHER
INFORMATIONCONTACT.''

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
     Explain your views/interests as clearly as possible.
     Describe any assumptions that you used.
     Provide copies of any technical information and/or data
you used that support your views.
     Make sure to submit your comments by the deadline in this
notice.
     To ensure proper receipt by EPA, be sure to identify the
docket control number assignedto this action in the subject line on the
first page of your response. You may also providethe name, date, and
Federal Register citation.

II. What Action is the Agency Taking?

    This notice announces the Agency's receipt of a request from the
registrant to amend theirpesticide products registered under section 3
of FIFRA. In a memorandum of agreement(``Agreement'') effective October
14, 1999, EPA and the registrant of products containingformetanate
hydrochloride agreed to several voluntary measures to reduce dietary,
agriculturalworker, and ecosystem risks associated with formetanate
hydrochloride exposure. EPA initiatedthe negotiations with registrants
after formetanate hydrochloride, as currently registered, wasfound to
pose an unacceptable dietary risk, especially to children ages 1 to 6
years old, risksof concern to agricultural workers, and unacceptable
risks to birds, terrestrial mammals, andaquatic invertebrates. As part
of the Agreement, the registrant agreed, among other things, toreduce
application rates on all food crops, reduce the number of applications,
and to take anumber of steps to reduce worker exposure. The registrant
also agreed to terminate formetanatehydrochloride product use on plums
and prunes, which appear to benefit little from use of theproduct, and
greenhouse grown ornamentals, to address worker risk concerns. In
return, EPAagreed at this time not to initiate any cancellation or
suspension proceedings under section 6(b)or 6(c) of FIFRA to achieve
the risk reduction measures set forth in the Agreement.
    In order to terminate formetanate hydrochloride use on plums,
prunes, and greenhousegrown ornamentals, the registrant has submitted a
request to

[[Page 6210]]

amend their registration of pesticideproducts containing formetanate
hydrochloride pursuant to section 6(f)(1)(A) of FIFRA.
Theseregistrations are listed in the following Table 1:

           Table 1.-- Registrations with Pending Use Deletions
------------------------------------------------------------------------
    Registration No.                         Product
------------------------------------------------------------------------
               45639-82  Formetanate HydrochlorideTechnical
              45639-163  Carzol SP
------------------------------------------------------------------------

    This notice also announces receipt by the Agency of an application
from the registrant tocancel six pesticide products registered under
section 24(c) of FIFRA. These registrations arelisted in alphabetic
order of the registration number in Table 2 below.





     Table 2.-- Registrations with Pending Requests for Cancellation
------------------------------------------------------------------------
    Registration No.                         Product
------------------------------------------------------------------------
            IN-97000400  Carzol SP
            NC-97000200  Carzol SP
            OH-97000800  Carzol SP
            SC-97000700  Carzol SP
            TX-98000800  Carzol SP
            UT-92000100  Carzol SP
------------------------------------------------------------------------

    The following Table 3 includes the name and address of record
forthe registrant of the products listed in Tables 1 and 2:

Table 3.-- Registrant Requesting Deleted Uses and Voluntary Cancellation
------------------------------------------------------------------------
   EPA
 Company                     Company name and address
   No.
------------------------------------------------------------------------
   45639  AgrEvo USA Company,Little Falls Centre One,2711 Centerville
           Road,Wilmington, DE 19808
------------------------------------------------------------------------

III. What is the Agency's Authority for Taking this Action?

    Under section 6(f)(1)(A) of FIFRA, registrants may request, at any
time, that theirpesticide registrations be canceled or amended to
terminate one or more pesticide uses. Section6(f)(1)(B) of FIFRA
further provides that, before acting on the request, EPA must publisha
notice of receipt of any such request in the Federal Register .
    Section 6(f)(1)(B) of FIFRA requires that EPA provide a 30-day
period in which thepublic may comment before the Agency may act on the
request to cancel registrations or deletepesticide uses. In the case of
minor agricultural uses, section 6(f)(1)(C) of FIFRA requires thatEPA
provide a 180-day comment period under certain circumstances.
    For this action, the registrant of formetanate hydrochloride has
requested that EPA waiveany public comment period provided in 6(f) of
FIFRA. In light of this request, EPA is grantingthe request to waive
the 180-day comment period, but is providing a 30-day public
commentperiod before taking action on the requested voluntary
cancellations and amendments to deleteuses.

IV. Procedures for Withdrawal of Request

    Registrants who choose to withdraw a request for cancellation must
submit such withdrawal in writing to the person listed under ``FOR
FURTHER INFORMATION CONTACT,'' postmarked before March 9, 2000. This
written withdrawal of the request for cancellation willapply only to
the applicable FIFRA section 6(f)(1) request listed in this notice. If
the product(s)have been subject to a previous cancellation action, the
effective date of cancellation and allother provisions of any earlier
cancellation action are controlling. The withdrawal request mustalso
include a commitment to pay any reregistration fees due, and to fulfill
any applicableunsatisfied data requirements.

V. Provisions for Disposition of Existing Stocks

    The registrant has requested amendment of the formetanate
hydrochloride registrationsidentified in Table 1 and voluntary
cancellation of the formetanate hydrochloride registrationsidentified
in Table 2. Pursuant to section 6(f) of FIFRA, EPA intends to grant the
requests forvoluntary amendment and cancellation. For purposes of the
cancellation order that the Agencyintends to issue at the close of the
comment period for this announcement, the term ``existingstocks'' will
be defined, pursuant to EPA's existing stocks policy as prescribed in
the FederalRegister of June 26, 1991, (56 FR 29362) (FRL-3846-4), as
those stocks of a registered pesticideproduct which are currently in
the United States and which have been packaged, labeled, andreleased
for shipment prior to the effective date of the amendment or
cancellation.
    As part of the October 14, 1999, Agreement negotiated with the
registrant, allformetanate hydrochloride products sold or distributed,
including existing stocks, (except for thepurpose of relabeling
according to the Agreement) by the registrant after December 1, 1999,
shallbear labeling approved by EPA pursuant to the Agreement. Moreover,
sale and distribution bypersons other than the registrant of products,
including existing stocks, not bearing labelingapproved by EPA pursuant
to the Agreement (except for the purpose of relabeling according tothe
Agreement), shall be prohibited after June 1, 2000.

VI. Notification of Intent to Revoke Tolerances

    This document also serves as an advance notification that the
Agency intends to proposeto revoke the tolerances found in: 40 CFR
180.276 for residues of formetanate hydrochloridein or on plums (fresh
prunes) and dried prunes. This action reflects the October 14,
1999,Agreement, in which the registrant agreed to delete the use of
formetanate hydrochlorideproducts on plums and prunes. In accordance
with the October 14, 1999, Agreement, the Agencyintends to revoke these
tolerances to help reduce acute dietary risks that currently exceed
themargins of safety deemed acceptable by the Agency. The Agency
intends that the tolerancerevocations become effective June 1, 2000.

VII. Import Tolerance Guidance

    The Agency is willing to consider requests to modify or maintain a
tolerance followingthe cancellation of the accompanying registration.
Such request should be sent to the personidentified in the ``FOR
FURTHER INFORMATION CONTACT'' section. If EPA receives arequest to
modify or maintain a tolerance in response to this Notice, the Agency
will issue aNotice under section 408(f) of FFDCA

[[Page 6211]]

informing the public of the data required to support thetolerance and
stating the time period for submitting the required data. Regardless of
whether atolerance applies solely to domestic food uses or solely to
imported foods, the same technicalchemistry and toxicology data are
required to support tolerances under FFDCA section 408. Forpesticide
chemicals used in or on food, EPA requires residue chemistry data that
arerepresentative of growing conditions in exporting countries in the
same manner that the EPArequires representative residue chemistry data
from different U.S. regions to support domesticuse of the pesticide and
the tolerance. Persons supporting the maintenance or modification
oftolerances to cover residues in or on imported food have the burden
of demonstrating therelevance of any existing domestic data to foreign
growing conditions.
    If EPA does not receive any indication of a need to retain a
tolerance for imported foodsfollowing the cancellation of the
registered food use, the Agency will publish in the FederalRegister a
notice proposing to revoke the tolerance. That notice will again give
interested partiesthe opportunity to come forward to support the
maintenance of the tolerance.

List of Subjects

    Environmental protection, Pesticides and pests, Product
registrations.

    Dated: February 1, 2000.
Lois A. Rossi,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. 00-2828 Filed 2-7-00; 8:45 am]
BILLING CODE 6560-50-F
Formetanate Hydrochloride; Receipt of Requests to Voluntarily Delete Uses, Request for Cancellation, and Advance Notification of Tolerance Revocation

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