[Federal Register Volume 67, Number 44 (Wednesday, March 6, 2002)]
[Notices]
[Pages 10193-10196]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-5315]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-66299; FRL-6824-9]
Acephate; Cancellation Order for Certain Uses and Products
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the cancellation order for all O,S-
dimethyl acetylphosphoramidothioate (or acephate) product registrations
cited in voluntary cancellation requests by acephate registrants Valent
USA Corporation, Micro Flo Company LLC, Drexel Chemical Company, United
Phosphorus, Inc., Whitmire Micro-Gen Research Labs, The Scotts Company,
and Pursell Technologies, Inc., and approved by EPA, pursuant to
section 6(f)(1) of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA). The product cancellation and use deletion requests were
submitted to reduce certain residential risks which exceeded the
Agency's level of concern. In a Notice of Receipt of Requests For
Amendments to Delete Uses and to Voluntarily Cancel Certain Product
Registrations (66 FR 59422) (FRL-6810-1) November 28, 2001, EPA
indicated that it would consider any public comments submitted within
the comment period before acting on the requests. The Agency, however,
received neither a comment nor withdrawal request. EPA hereby issues in
this notice a cancellation order approving the requested cancellations
and use deletions. 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 approved product cancellation and use deletion dates are
outlined in Tables 1, 2, and 3 of this notice.
FOR FURTHER INFORMATION CONTACT: By mail: Kimberly Lowe, Special Review
and Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460: telephone number: (703) 308-8059: fax number:
(703) 308-8005: 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 acephate 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 homepage at http://www.epa.gov/.
To access this document, on the homepage 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 for acephate, go to the homepage for the Office of Pesticide
Programs or go directly to http://www.epa.gov/pesticides/op/acephate.htm.
2. In person. The Agency has established an official record for the
Interim Reregistration Eligibility Decision action on acephate under
docket control number OPP-34164A. The official record consists of the
documents 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. Requests to Cancel and Amend Registrations to Delete Uses
A. Background
During development of the Interim Reregistration Eligibility
Decision (IRED) on the organophosphorus pesticide, acephate, EPA
identified risks of concern for residents, including children, who
contact treated surfaces in homes following indoor application. EPA
also identified a risk of concern for young children playing on lawns
treated with acephate. To voluntarily address these health risk
concerns, Valent and all other relevant acephate registrants agreed to
request amendment of their registrations to delete these uses.
The IRED for acephate completed on September 30, 2001, and
announced in the Federal Register (January 30, 2002) (67 FR 4426) (FRL-
6821-1), noted the need to consult with the Secretary of Health and
Human Services prior to approving a certain request to cancel
[[Page 10194]]
products or delete uses associated with a public health pesticide.
Although it is unclear whether acephate is a public health pesticide,
as a courtesy, EPA consulted with the Centers for Disease Control and
Prevention, as well with officials from the Department of Agriculture's
Animal and Plant Health Inspection Service before issuing this
cancellation order.
The primary technical registrant, Valent, submitted a written
request on October 15, 2001 to EPA, seeking to amend its manufacturing-
use product (MUP) registrations and end-use product (EUP) registrations
for acephate. Valent requested that EPA amend all of its registered
products to delete the use of acephate on residential indoor and
turfgrass sites (except golf courses, sod farms, and spot or mound
treatment for harvester and fire ant control). The use deletion
requests involved seven FIFRA section 3 registrations held by Valent.
Valent also requested the voluntary cancellation of one section 3
manufacturing use registration and eight Special Local Need
registrations under FIFRA section 24(c). These cancellation requests
were conditioned on EPA granting certain existing stock provisions.
Nearly identical use deletion requests were received from the other
three technical registrants of acephate: Drexel Chemical Company,
United Phosphorus, Inc., and Micro Flo Company LLC. Furthermore, the
remaining end use product registrants, Whitmire Micro-Gen Research
Labs, The Scotts Company, and Pursell Technologies, Inc., made similar
use deletion requests. All registrants requested that EPA waive any
applicable 180-day public comment period for EPA action on its
requests.
For the purposes of this use deletion action, ``residential use''
refers to use sites within the definition of the term at 40 CFR
152.3(u). Thus, residential indoor sites refers to all ``residential
use'' sites that are indoors. The ``turfgrass'' use deletion refers to
any turfgrass use site, unless the specific turf use site or pest is
excepted, as described in this notice. Thus, turfgrass use directions
on revised labeling would be limited to golf course, sod farm, and spot
or mound treatment for harvester or fire ant control.
In response to the requests to delete uses and cancel certain
product registrations, EPA published a Notice of Receipt of Requests
For Amendments to Delete Uses and to Voluntarily Cancel Certain Product
Registrations for acephate (66 FR 59422, November 28, 2001). In that
notice, EPA waived the 180-day public comment period, as requested, and
indicated that during the 30-day public comment period that was
provided it would consider any comments submitted by December 28, 2001
before deciding whether to act on the requests. Neither a comment was
received from any member of the public nor a withdrawal request made by
any registrant in regard to this announcement. EPA also considered the
registrants' existing stocks request and believes that such a provision
is consistent with EPA policy on existing stocks and standards
established under FIFRA.
B. Requests for Voluntary Amendments of Manufacturing-Use Product
Registrations to Delete Certain Uses
Table 1 specifies the time frame for the use deletions and use of
existing stocks of manufacturing use products by formulators.
``Turfgrass'' in the context of Table 1 does not include the excepted
uses of golf course, sod farm, and/or spot or mound treatment for
harvester and fire ant control (unless otherwise specified). In
addition to conditions specified in Table 1, registrants may continue
formulating acephate products from these manufacturing use products
labeled with deleted uses into end use products labeled exclusively for
non-deleted uses, provided the other time frames in the following Table
1 are followed. Such formulation may continue until registrant supplies
of the manufacturing use product are exhausted. In accordance with the
proposed timetable for the use deletions, all manufacturing use product
registrations labeled for formulation into pesticides with indoor
residential uses or turfgrass uses were officially amended on or
shortly after the proposed use deletion date of December 31, 2001.
Based on proposed labeling submitted by MUP registrants to terminate
the subject uses, the Agency approved amendments to three MUPs on
December 31, 2001 and one MUP on January 11, 2002.
Table 1.--Acephate Manufacturing Use Products: Use Deletions and Use of Existing Stocks
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Last Date for Use of Existing Stocks to Last Date for
Formulate End Use Products with Deleted Uses Registrant to Sell
MUP Registration Actual Amended Label ---------------------------------------------- and Distribute
Company Number Date Existing Stocks of
Indoor Residential Turfgrass Products Bearing
Deleted Uses
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Drexel Chemical Company............ 19713-410............. 1-11-02............... 1-11-02.............. 10-31-02............. 1-11-02
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Micro Flo Company.................. 51036-246............. 12-31-01.............. 12-31-01............. 10-31-02............. 12-31-01
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Valent USA Corp.................... 59639-41.............. 12-31-01.............. 12-31-01............. 10-31-02............. 12-31-01
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United Phosphorus, Inc............. 70506-3............... 12-31-01.............. 12-31-01............. 10-31-02............. 12-31-01
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C. Requests for Voluntary Amendments of End-Use Product Registrations
to Delete Certain Uses
Table 2 specifies the time frame for implementing the requested use
deletions and outlines the conditions for use of existing stocks for
affected end use products. The conditions described in this table
pertain to the end use registrants of acephate. (N/A in Table 2 means
``not applicable.'') In accordance with the proposed timetable for the
use deletions and in response to proposed labeling submitted by EUP
registrants, all EUP registrations labeled for indoor residential uses
were officially amended to terminate indoor residential uses on (or
within one month of) the proposed use deletion date of December 31,
2001.
End use products labeled for turfgrass will be amended to terminate
certain
[[Page 10195]]
turfgrass uses, no later than October 31, 2002. ``Turfgrass'' in the
context of Table 2 does not include the excepted uses of golf course,
sod farm, and/or spot or mound treatment for harvester and fire ant
control (unless otherwise specified). Nearly all registrants of product
registrations labeled for turfgrass uses have submitted proposed
labeling to terminate the subject turfgrass uses before the proposed
use deletion date. EPA has already approved five label amendments and
is currently reviewing the balance of the submissions. Product
registrations shown in the following Table 2 with the entry, ``no later
than 10-31-02'', refers to turfgrass product registrations for which
proposed labels are still under EPA review or pending. The effective
date for the turfgrass use deletion is either the date of EPA approval
for the label amendment terminating the use, or October 31, 2002,
whichever comes first.
Table 2.--Acephate End Use Products: Use Deletions and Use of Existing Stocks
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Last Date for Sale and Distribution of
EUP Registration Effective Date of Existing Stocks by the Registrant
Company Number Use Deletions ---------------------------------------
Indoor Residential Turfgrass
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The Scotts Company.............. 239-2406.......... N/A............... No later than..... 12-31-02
10-31-02..........
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.............................. 239-2436.......... N/A............... No later than..... 12-31-02
10-31-021.........
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.............................. 239-2440.......... 1-30-02........... N/A............... 12-31-02
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.............................. 239-2461.......... N/A............... No later than..... 12-31-02
10-31-021.........
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.............................. 239-2632.......... N/A............... No later than..... 12-31-02
10-31-02..........
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Whitmire Micro-Gen.............. 499-373........... 12-31-01.......... N/A............... 12-31-02
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Drexel Chemical Co.............. 19713-495......... 1-11-02........... N/A............... 12-31-02
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.............................. 19713-497......... N/A............... 1-28-02........... 12-31-02
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Micro Flo Company............... 51036-236......... N/A............... 12-31-01.......... 12-31-02
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.............................. 51036-252......... N/A............... 1-28-02........... 12-31-02
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.............................. 51036-237......... 12-31-01.......... N/A............... 12-31-02
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.............................. 51036-337......... N/A............... 12-31-01.......... 12-31-02
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Valent USA Corporation.......... 59639-26.......... N/A............... No later than..... 12-31-02
10-31-02..........
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.............................. 59639-28.......... N/A............... No later than..... 12-31-02
10-31-02..........
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.............................. 59639-31.......... 1-11-02........... N/A............... 12-31-02
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.............................. 59639-33.......... N/A............... No later than..... 12-31-02
10-31-02..........
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.............................. 59639-87.......... N/A............... No later than..... 12-31-02
10-31-02..........
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.............................. 59639-91.......... N/A............... No later than..... 12-31-02
10-31-02..........
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United Phosphorus, Inc.......... 70506-1........... N/A............... No later than..... 12-31-02
10-31-021.........
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Pursell Technologies............ 73614-1........... N/A............... 1-30-02........... 12-31-02
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1Exception for harvester ant control on turfgrass does not apply to this product; other turfgrass exceptions do
apply.
D. Requests for Voluntary Cancellation of Product Registrations
As mentioned above, Valent also requested the voluntary
cancellation of nine acephate product registrations. The products
identified by Valent's one section 3 MUP registration and eight section
24(c) (or Special Local Need) registrations are shown in the following
Table 3. Insofar as these cancelled product registrations contain one
or more of the subject indoor residential
[[Page 10196]]
and turfgrass uses, the existing stocks provisions outlined in Table 2
apply.
Table 3.--Acephate Product Registration Cancellation Requests
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Product
Company/Address Registration Product Name
Number
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Valent USA Corporation........ 59639-42......... Valent Orthene
1333 N. California Blvd., Ste. MFG.
600.
Walnut Creek, CA 94596........
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............................ AL960001......... Pinpoint 15
granular.
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............................ FL890016......... Orthene turf,
tree and
ornamental spray.
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............................ FL960007......... Pinpoint 15
granular.
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............................ GA970002......... Pinpoint 15
granular.
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............................ LA950011......... Pinpoint 15
granular.
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............................ MS960016......... Pinpoint 15
granular.
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............................ SC960001......... Pinpoint 15
granular.
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............................ TX960011......... Pinpoint 15
grandular.
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III. Cancellation Order
Pursuant to section 6(f) of FIFRA, EPA hereby approves the
requested acephate product registration cancellations and amendments to
terminate all indoor residential uses and all turfgrass uses, except
golf course, sod farm, and/or spot or mound treatment for harvester and
fire ant control, as identified for deletion in the acephate 6(f)
notice of receipt published on November 28, 2001. Accordingly, the
Agency orders that all of the uses identified in Tables 1, and 2 are
hereby deleted from the acephate product registrations in accordance
with the time frames given in this notice. The Agency also orders that
the acephate product registrations identified in Table 3 are hereby
canceled. Any distribution, sale, or use of existing stocks of the
products identified in Tables 1, 2, and 3 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 Provisions
Pursuant to section 6 of FIFRA, EPA grants the existing stocks
provisions contained within the requests for voluntary amendment and
cancellation, as described in large part by the time frames shown in
Tables 1, and 2. For purposes of this cancellation order, the term
``existing stocks'' is defined, pursuant to EPA's Existing Stocks
Policy published in the Federal Register of June 26, 1991 (56 FR
29362), 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 this cancellation order that is not
consistent with the terms of this order will be considered a violation
of section 12(a)(2)(K) and/or 12(a)(1)(A) of FIFRA.
A. Distribution, Sale, and Use of Products with Deleted Uses by
Registrants
The distribution, sale, or use of such stocks by the registrants
(including supplemental registrants) of acephate products is not lawful
under FIFRA after the sale, distribution, and use dates listed in
Tables 1, and 2, 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 effective date of the
use cancellations for the manufacturing-use products is the approval
date of the label amendment. The effective date of the use
cancellations for the end-use products labeled for indoor residential
use is either the approval date of the label amendment or, if the label
amendment is still unapproved, the date of this cancellation order. The
effective date of the use deletions for the end-use products labeled
for use on turfgrass is either the approval date of the label amendment
or October 31, 2002, whichever occurs first.
B. Distribution, Sale, and Use of Products with Deleted Uses by Persons
Other than Registrants
Retailers, distributors, and end-users may sell, distribute, or use
existing stocks of end-use products subject to this order, as presented
in Table 2, until such supplies are exhausted.
C. Distribution, Sale, and Use of Canceled Products
The effective date of the product cancellations is the date of this
cancellation order. Except as provided below, the registrant may sell
or distribute existing stocks for 1 year after the date that the
cancellation request was received by the Agency, which in this case was
October 15, 2001. Registrants are also subject to the time frames and
existing stocks provisions above in Units IV. A, and B for products
with any uses subject to the use deletions in this order and existing
stocks provisions. Unless the provisions of an earlier order apply,
existing stocks already in the hands of dealers or users can be
distributed, sold or used legally until they are exhausted, provided
that such further sale and use comply with the EPA-approved label and
labeling of the affected product(s).
Lists of Subjects
Environmental protection, Cancellation, Pesticides and pests.
Dated: February 22, 2002.
Lois A. Rossi,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. 02-5315 Filed 3-5-02; 8:45 am]
BILLING CODE 6560-50-S