[Federal Register Volume 65, Number 26 (Tuesday, February 8, 2000)]
[Notices]
[Pages 6208-6211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-2828]


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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: 
[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 
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:``[email protected],'' 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
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    Registration No.                         Product
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               45639-82  Formetanate HydrochlorideTechnical
              45639-163  Carzol SP
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    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
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    Registration No.                         Product
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            IN-97000400  Carzol SP
            NC-97000200  Carzol SP
            OH-97000800  Carzol SP
            SC-97000700  Carzol SP
            TX-98000800  Carzol SP
            UT-92000100  Carzol SP
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    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
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   EPA
 Company                     Company name and address
   No.
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   45639  AgrEvo USA Company,Little Falls Centre One,2711 Centerville
           Road,Wilmington, DE 19808
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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