02-5315. Acephate; Cancellation Order for Certain Uses and Products

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

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: [phone]: fax number: [phone]: e-mail address: [e-mail].

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 [phone].

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 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

Company	MUP Registration Number	Actual Amended Label Date	Last Date for Use of Existing Stocks to Formulate End Use Products with Deleted Uses		Last Date for Registrant to Sell and Distribute Existing Stocks of Products Bearing Deleted Uses
			Indoor Residential	Turfgrass
Drexel Chemical Company	19713-410	1-11-02	1-11-02	10-31-02	1-11-02
Micro Flo Company	51036-246	12-31-01	12-31-01	10-31-02	12-31-01
Valent USA Corp.	59639-41	12-31-01	12-31-01	10-31-02	12-31-01
United Phosphorus, Inc.	70506-3	12-31-01	12-31-01	10-31-02	12-31-01

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 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

Company	EUP Registration Number	Effective Date of Use Deletions	Last Date for Sale and Distribution of Existing Stocks by the Registrant
			Indoor Residential	Turfgrass
The Scotts Company	239-2406	N/A	No later than 10-31-02	12-31-02
	239-2436	N/A	No later than 10-31-021	12-31-02
	239-2440	1-30-02	N/A	12-31-02
	239-2461	N/A	No later than 10-31-021	12-31-02
	239-2632	N/A	No later than 10-31-02	12-31-02
Whitmire Micro-Gen	499-373	12-31-01	N/A	12-31-02
Drexel Chemical Co.	19713-495	1-11-02	N/A	12-31-02
	19713-497	N/A	1-28-02	12-31-02
Micro Flo Company	51036-236	N/A	12-31-01	12-31-02
	51036-252	N/A	1-28-02	12-31-02
	51036-237	12-31-01	N/A	12-31-02
	51036-337	N/A	12-31-01	12-31-02
Valent USA Corporation	59639-26	N/A	No later than 10-31-02	12-31-02
	59639-28	N/A	No later than 10-31-02	12-31-02
	59639-31	1-11-02	N/A	12-31-02
	59639-33	N/A	No later than 10-31-02	12-31-02
	59639-87	N/A	No later than 10-31-02	12-31-02
	59639-91	N/A	No later than 10-31-02	12-31-02
United Phosphorus, Inc.	70506-1	N/A	No later than 10-31-021	12-31-02
Pursell Technologies	73614-1	N/A	1-30-02	12-31-02
1 Exception 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 and turfgrass uses, the existing stocks provisions outlined in Table 2 apply.

Table 3.—Acephate Product Registration Cancellation Requests

Company/Address	Product Registration Number	Product Name
Valent USA Corporation 1333 N. California Blvd., Ste. 600 Walnut Creek, CA 94596	59639-42	Valent Orthene MFG
	AL960001	Pinpoint 15 granular
	FL890016	Orthene turf, tree and ornamental spray
	FL960007	Pinpoint 15 granular
	GA970002	Pinpoint 15 granular
	LA950011	Pinpoint 15 granular
	MS960016	Pinpoint 15 granular
	SC960001	Pinpoint 15 granular
	TX960011	Pinpoint 15 grandular

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.