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Azinphos Methyl - Cancellation Request and Tolerance Revocations 11/99

[Federal Register: December 3, 1999 (Volume 64, Number 232)]
[Notices]
[Page 67899-67902]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03de99-84]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-64043; FRL-6394-8]
Azinphos Methyl; Receipt of Requests For Amendments to Delete
Uses; Request For Cancellation, and Advance Notification of Tolerance
Revocation and Modifications
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The companies that hold the pesticide registrations of
pesticide products containing azinphos methyl (O,O-dimethyl-S-((4-oxo-
1,2,3-benzotriazin 3(4H)-yl)methyl) phosphorodithioate) have asked EPA
to amend their registrations to delete use on cotton in Louisiana and
east of the Mississippi River, and on sugarcane, ornamentals (except
for nursery stocks), Christmas trees, shade trees, and forest trees.
One company has also asked EPA to cancel some of its registrations of
pesticide products containing azinphos methyl. Pursuant to section
6(f)(1) of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), EPA is announcing the Agency's receipt of these requests from
the registrants. The requests to cancel certain uses from the
registrations are the result of an agreement between EPA and several
registrants regarding the registration of products containing azinphos
methyl. Given the potential risks that azinphos methyl use on cotton in
Louisiana and east of the Mississippi River, sugarcane, ornamentals
(except for nursery stock), Christmas trees, shade trees, and forest
trees has on drinking water and ecosystems, EPA intends to grant the
requested amendments to delete uses. The Agency also intends to grant
the requested registration cancellations. In addition, EPA plans to
issue a cancellation order for the deleted uses and the canceled
registrations at the close of the comment period for this announcement.
After publication of the cancellation order, any distribution, sale, or
use of azinphos methyl products will only be permitted if such
distribution, sale, or use is consistent with the terms of that order.
DATE: Comments on the requested amendments to delete uses and the
requested registration cancellations must be submitted to the address
provided below by January 3, 2000.
ADDRESSES: Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit I.C. of the "SUPPLEMENTARY INFORMATION" section. To
ensure proper receipt by EPA, it is imperative that you identify docket
control number OPP-64043 in the subject line on the first page of your
response.
 FOR FURTHER INFORMATION CONTACT: By mail: Barry O'Keefe, Special
Review and Reregistration Division (7508C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460, telephone number: 703-308-8035, e-mail address:
okeefe.barry@epa.gov.
SUPPLEMENTARY INFORMATION: This announcement consists of five parts.
The first part contains general information. The second part addresses
the registrants' requests for amendments to delete uses and for
voluntary cancellation of registrations. The third part proposes
existing stock provisions that will be set forth in the cancellation
order that the Agency intends to issue at the close of the comment
period for this announcement. The fourth part provides advance
notification of tolerance revocation and modifications the Agency
intends to propose. And the fifth part sets forth the Agency's import
tolerance guidance.

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you manufacture,
sell, distribute, or use azinphos methyl 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). If you have
any questions regarding the applicability of this action to a
particular entity, consult the technical person listed in the "FOR
FURTHER INFORMATION CONTACT" section.

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

    1. Electronically. You may obtain copies of this document and
certain other available support documents from the EPA Internet Home
Page at http://www.epa.gov/. You may access this document by selecting
"Laws and Regulations" on EPA's Home Page and then looking 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 for azinphos methyl, go to the Home Page for the
Office of Pesticide Programs or go directly http://www/epa.gov/
oppsrrd1/op/azm.htm.
    2. In person. The Agency has established an official record for
this action under docket control number [OPP-64043]. 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 Highway,
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.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or
electronically. To ensure proper receipt by EPA, it is imperative that
you identify docket control number [OPP-64043] in the subject line on
the first page of your response.

[[Page 67900]]

    1. 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, 401 M St., SW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Information Resources
and Services Division (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB
telephone number is 703-305-5805.
    3. 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 submit any information electronically that you
consider to be CBI. Avoid the use of special characters and any form of
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be
identified by the docket control number 34161. Electronic comments may
also be filed online at many Federal 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 may claim information that you submit to EPA in response to
this document as CBI by marking any part or all of that information as
CBI. Information so marked will not be disclosed except in accordance
with procedures set forth in 40 CFR part 2. In addition to one complete
version of the comment that includes any information claimed as CBI, a
copy of the comment that does not contain the information claimed as
CBI must be submitted for inclusion in the public version of the
official record. Information not marked confidential will be included
in the public version of the official record without prior notice. If
you have any questions about CBI or the procedures for claiming CBI,
please consult the person identified in the "FOR FURTHER INFORMATION
CONTACT" section.

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 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.
    * If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    * Provide specific examples to illustrate your concerns.
    * Make sure to submit your comments by the deadline in this
announcement.
    * To ensure proper receipt by EPA, be sure to identify the docket
control number assigned to this action in the subject line on the first
page of your response. You may also provide the name, date, and Federal
Register citation.

II. Receipt of Requests to Delete Uses And to Cancel Registrations

A. Requests for Amendments to Delete Uses

    In a memorandum of agreement ("Agreement") effective August 2,
1999, EPA and a number of registrants of products containing azinphos
methyl agreed to several voluntary measures to reduce the dietary,
agricultural worker, and ecosystem risks associated with azinphos
methyl exposure. EPA initiated the negotiations with registrants after
azinphos methyl, as currently registered, was found to pose an
unacceptable dietary risk to children ages 1 to 6 years old, risks of
concern to agricultural workers, and unacceptable risks to birds,
aquatic invertebrates, fish, and terrestrial mammals. As part of the
Agreement, the signatory registrants, among other things, agreed to
reduce application rates on pome fruit, to cap production of azinphos
methyl products available in the United States, and to take a number of
steps to reduce worker exposure. The signatory registrants also agreed
to delete the use of azinphos methyl products on cotton in Louisiana
and east of the Mississippi River, sugarcane, ornamentals (except for
nursery stocks), Christmas trees, shade trees, and forest trees. In
return, EPA agreed 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 delete azinphos methyl use on cotton in Louisiana and
east of the Mississippi River, sugarcane, ornamentals (except for
nursery stocks), Christmas trees, shade trees, and forest trees, the
signatory registrants have submitted requests to amend their
registrations of pesticide products containing azinphos methyl to
delete such uses pursuant to section 6(f)(1)(A) of FIFRA. In addition,
a registrant that did not sign the Agreement has also submitted a
request to amend its registrations of pesticide products containing
azinphos methyl to delete such uses. The registrations for which
amendments were requested are identified in the following Table 1.

                                Table 1.--Registrations With Requested Amendments
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                    Company                        Reg. No                  Product                    SLNs
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Bayer Corporation..............................     3125-108  85% Technical
  .............................................     3125-102  22.2% Emulsifiable Concentrate
  .............................................     3125-301  50% Wettable Powder                     NJ94000300
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Makhteshim Chemical Works, Ltd.................      11678-4  85% Technical
  .............................................     11678-53  85% Formulation Intermediate

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Makhteshim-Agan of North America, Inc..........     66222-11  50% Wettable Powder
  .............................................     66222-12  22.1% Emulsifiable Concentrate
  .............................................     66222-16  22.1% Emulsifiable Concentrate
----------------------------------------------------------------------------------------------------------------
Gowan Company..................................     10163-78  50% Wettable Powder                     AZ94000800
  .............................................     10163-80  22.2% Emulsifiable Concentrate
  .............................................     10163-95  85% Technical
  .............................................    10163-138  35% Wettable Powder
  .............................................    10163-139  35% Wettable Powder

[[Page 67901]]

  .............................................    10163-180  50% PVA (Water Soluble Bags)
----------------------------------------------------------------------------------------------------------------

Micro-Flo Corporation..........................     51036-76  22.2% Emulsifiable Concentrate          AZ99000500
  .............................................    51036-130  35% Wettable Powder                     AZ99000500
  .............................................    51036-164  50% Water Dispensable Granules          AZ99000500
----------------------------------------------------------------------------------------------------------------
Platte Chemical Company........................    34704-691  22.2% Emulsifiable Concentrate
----------------------------------------------------------------------------------------------------------------

    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)(B) of FIFRA requires that EPA
provide a 30-day period in which the public may comment before the
Agency may act on the request for voluntary cancellation. However, such
comment period may be waived upon a registrant's request. In addition,
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 (1) the registrants request a
waiver of the comment period, or (2) the Administrator determines that
continued use of the pesticide would pose an unreasonable adverse
effect on the environment. The registrants have requested that EPA
waive the 180-day comment period. In light of this request, EPA is
granting the request to waive the 180-day comment period and is
providing a 30-day public comment period before taking action on the
requested amendments to delete uses.
    As part of the Agreement negotiated with the registrants, the
registrants agreed to relabel all stocks of azinphos methyl products
that are under their control by December 1, 1999. Any distribution or
sale of existing stocks of azinphos-methyl products by the registrants
will be unlawful after December 1, 1999. Any distribution or sale of
such stocks by persons other than the registrants will be unlawful
after December 31, 1999. Given the potential risks that azinphos methyl
use on cotton in Louisiana and east of the Mississippi River,
sugarcane, ornamentals (except nursery stock), Christmas trees, shade
trees, and forest trees has on drinking water and ecosystems, EPA
intends to grant the requested amendments to delete uses at the close
of the comment period for this announcement.

B. Request for Voluntary Cancellation

    In addition to requesting amendments to delete uses, one registrant
has submitted a request for voluntary cancellation of some of its
registrations of pesticide products containing azinphos methyl. The
registrations for which cancellation was requested are identified in
the following Table 2.

                               Table 2.--Registrations With Cancellation Requests
----------------------------------------------------------------------------------------------------------------
                    Company                         Reg. No                  Product                   SLNs
----------------------------------------------------------------------------------------------------------------
Micro-Flo Corporation.........................                  22.2% Emulsifiable Concentrate        TX89001100
  ............................................       51036-205  50% Wettable Powder
  ............................................       51036-207  22.2% Emulsifiable Concentrate
----------------------------------------------------------------------------------------------------------------

    Under section 6(f)(1)(A) of FIFRA, registrants may request, at any
time, that EPA cancel any of their pesticide registrations. The
registrant has requested that EPA waive any applicable comment periods
before taking action on its request for cancellation. In light of this
request, EPA is granting the request to waive the 180-day comment
period and is providing a 30-day public comment period before taking
action on the requested cancellations. Given the potential risks that
azinphos methyl use poses, EPA intends to grant the requested
cancellations at the close of the comment period for this announcement.

III. Proposed Existing Stocks Provisions

    The registrants have requested voluntary amendment of the azinphos
methyl registrations identified in Table 1 and voluntary cancellation
of the azinphos methyl registrations identified in Table 2. Pursuant to
section 6(f) of FIFRA, EPA intends to grant the requests for voluntary
amendment and cancellation. For purposes of the cancellation order that
the Agency intends to issue at the close of the comment period for this
announcement, the term "existing stocks" will be defined, pursuant to
EPA's existing stocks policy at 56 FR 29362, Wednesday, June 26, 1991,
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 the Agency intends to
issue 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.

A. Distribution or Sale by Registrants

    Unless existing stocks of products identified in Table 1 are
relabeled in a manner consistent with the Agreement, the distribution
or sale of such stocks by registrants will not be lawful under FIFRA
after December 31, 1999, 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. In
addition, the distribution or sale of existing stocks of products
identified in Table 2 by registrants will not be lawful under FIFRA
after December 31, 1999, except for the purposes of shipping such
stocks for export consistent with the requirements of section 17 of
FIFRA or for proper disposal.

B. Distribution or Sale by Other Persons

    Unless existing stocks of products identified in Table 1 are
relabeled in a

[[Page 67902]]

manner consistent with the Agreement, the distribution or sale of such
stocks by persons other than registrants will not be lawful under FIFRA
after December 31, 1999, 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. The
distribution or sale of existing stocks of products identified in Table
2 by persons other than registrants will not be lawful under FIFRA
after December 31, 1999, except for the purposes of shipping such
stocks for export consistent with the requirements of section 17 of
FIFRA or for proper disposal.

C. Use of Existing Stocks

    The use of existing stocks of products identified in Tables 1 and 2
on cotton in Louisiana and east of the Mississippi River, sugarcane,
ornamentals (except nursery stock), Christmas trees, shade trees, and
forest trees will be lawful under FIFRA until stocks are depleted
provided that the use is in accordance with either the directions for
use contained in the Agreement or the existing labeling of that
product.

IV. Notification of Intent to Revoke Tolerances

    This document also serves to give notice that the Agency intends to
propose to revoke the tolerance found in 40 CFR 180.154 for residues of
azinphos-methyl in or on sugarcane with a revocation/expiration date of
June 30, 2000. Accordingly, the Agency will issue such a proposed rule
to be published in the Federal Register. In the August 2, 1999,
Agreement, the registrants agreed to cancel the use of azinphos methyl
products on sugarcane. The Agreement states that azinphos methyl
manufacturing-use products may not be reformulated for use on
sugarcane, and that end-use product labels intended for use in the 2000
growing season shall not have sugarcane listed as a use site in the
directions for use section.
    In addition, this document serves to give notice that the Agency
intends to propose to lower tolerances found in 40 CFR 180.154 for
residues of azinphos-methyl in or on apples, crabapples, cranberries,
grapes, pears, and quinces. The Agency will issue such a proposed rule
to be published in the Federal Register. In the August 2, 1999,
Agreement, the registrants agreed to submit a petition requesting
specific tolerance modifications for these fruits to be effective
January 1, 2000. The Agency has received such a petition and intends to
lower these tolerances to help reduce acute dietary risks that
currently exceed the margins of safety deemed acceptable by the Agency.

 V. Import Tolerance Guidance

    The Agency recognizes that interested parties may want to retain a
tolerance in the absence of a U.S. registration, to allow legal
importation of food into the United States. To assure that all food
marketed in the United States is safe, under the FFDCA, EPA may require
the same technical chemistry and toxicology data for such import
tolerances (tolerances without related U.S. registrations) as required
to support U.S. food use registrations and any resulting tolerances. In
addition, EPA may require residue chemistry data (crop field trials)
that are representative of growing conditions in exporting countries in
the same manner that the Agency requires representative residue
chemistry data from different U.S. regions to support domestic use of
the pesticides and the tolerance. Interested parties should contact the
Agency for written guidance on adapting U.S. residue chemistry data
requirements to non-U.S. growing conditions in order to support an
import tolerance.

List of Subjects

    Environmental protection, Memorandum of Agreement, Pesticides and
pests.

    Dated: November 23, 1999.

Lois Rossi,

Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. 99-31350 Filed 11-30-99; 3:02 pm]
BILLING CODE 6560-50-P