00-2828. 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.

SUMMARY:

AgrEvo USA Company, the company that holds the pesticide registration of pesticide products containing formetanate hydrochloride (m-[[(dimethylamino)methylene]amino]phenyl methylcarbamate hydrochloride) has asked EPA to amend its registration to delete use on plums, prunes, and greenhouse grown ornamental plants,and cancel six pesticide products registered for greenhouse grown ornamental plants under section 24(c) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). In accordance with section 6(f)(1) of FIFRA, as amended, EPA is issuing a notice of receipt of this request by the registrant. The request to delete the aforementioned uses from the registration, and voluntary cancellation of 24(c) registrations for greenhouse grown ornamental plants are the result of an agreement between EPA and the registrant regarding the registration of pesticide products containing formetanate hydrochloride. Given the potential dietary risks from formetanate hydrochloride use on registered food crops, the registrant requested, among other things, that uses that appear to be of little benefit (i.e., plums and prunes) be deleted from pesticide product labels. In addition, due to potential worker exposure risks from formetanate hydrochloride pesticide product use on greenhouse grown ornamental plants, the registrant requested that this use 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, EPA intends to grant the requested amendments to delete uses and voluntary registration cancellations.

DATES:

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

FOR FURTHER INFORMATION CONTACT:

By mail: Michael Goodis, Special Review and Reregistration Division (7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Avenue, NW, Washington, DC 20460; telephone [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 potentially be affected by this action if you manufacture, sell, distribute, or use pesticide products containing the active ingredient formetanate hydrochloride. Formetanate hydrochloride, trade name is Carzol® SP, is an insecticide/miticide of the carbamate class, and is presently registered in the United States and is used on citrus, stone and pome fruits, alfalfa (grown for seed), and greenhouse grown ornamental plants. AgrEvo USA Company is the sole technical manufacturer of formetanate hydrochloride.

Although this action may be of particular interest to persons who produce or use pesticides, 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 information in this notice, 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?

Electronically. You may obtain electronic copies of this document,and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/​. To access this document, on the Home Page select “Laws and Regulations” 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/​.

In Person. The Agency has established an official record for this action under docket control number OPP-64046. 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 Hwys, Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is [phone].

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-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, DC 20460.

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 Hwys, 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 [phone].

Electronically. You may submit your comments electronically by E-mail to:“[e-mail],” 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 OPP-64046. 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.”

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 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. What Action is the Agency Taking?

This notice announces the Agency's receipt of a request from the registrant to amend their pesticide products registered under section 3 of FIFRA. In a memorandum of agreement(“Agreement”) effective October 14, 1999, EPA and the registrant of products containing formetanate hydrochloride agreed to several voluntary measures to reduce dietary, agricultural worker, and ecosystem risks associated with formetanate hydrochloride exposure. EPA initiated the negotiations with registrants after formetanate hydrochloride, as currently registered, was found to pose an unacceptable dietary risk, especially to children ages 1 to 6 years old, risks of concern to agricultural workers, and unacceptable risks to birds, terrestrial mammals, and aquatic invertebrates. As part of the Agreement, the registrant agreed, among other things, to reduce application rates on all food crops, reduce the number of applications, and to take a number of steps to reduce worker exposure. The registrant also agreed to terminate formetanate hydrochloride product use on plums and prunes, which appear to benefit little from use of the product, and greenhouse grown ornamentals, to address worker risk concerns. In return, EPA agreed 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 greenhouse grown ornamentals, the registrant has submitted a request to amend their registration of pesticide products containing formetanate hydrochloride pursuant to section 6(f)(1)(A) of FIFRA. These registrations are listed in the following Table 1:

Table 1.— Registrations with Pending Use Deletions

Registration No.	Product
45639-82	Formetanate Hydrochloride Technical
45639-163	Carzol® SP

This notice also announces receipt by the Agency of an application from the registrant to cancel six pesticide products registered under section 24(c) of FIFRA. These registrations are listed 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 for the registrant of the products listed in Tables 1 and 2:

Table 3.— Registrant Requesting Deleted Uses and Voluntary Cancellation

EPA Company No.	Company name and address
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 their pesticide registrations be canceled or amended to terminate one or more pesticide uses. Section 6(f)(1)(B) of FIFRA further provides that, before acting on the request, EPA must publish a 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 the public may comment before the Agency may act on the request to cancel registrations or delete pesticide uses. In the case of minor agricultural uses, section 6(f)(1)(C) of FIFRA requires that EPA provide a 180-day comment period under certain circumstances.

For this action, the registrant of formetanate hydrochloride has requested that EPA waive any public comment period provided in 6(f) of FIFRA. In light of this request, EPA is granting the request to waive the 180-day comment period, but is providing a 30-day public comment period before taking action on the requested voluntary cancellations and amendments to delete uses.

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 will apply 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 all other provisions of any earlier cancellation action are controlling. The withdrawal request must also include a commitment to pay any reregistration fees due, and to fulfill any applicable unsatisfied data requirements.

V. Provisions for Disposition of Existing Stocks

The registrant has requested amendment of the formetanate hydrochloride registrations identified in Table 1 and voluntary cancellation of the formetanate hydrochloride 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 as prescribed in the Federal Register of June 26, 1991, (56 FR 29362) (FRL-3846-4), 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.

As part of the October 14, 1999, Agreement negotiated with the registrant, all formetanate hydrochloride products sold or distributed, including existing stocks, (except for the purpose of relabeling according to the Agreement) by the registrant after December 1, 1999, shall bear labeling approved by EPA pursuant to the Agreement. Moreover, sale and distribution by persons other than the registrant of products, including existing stocks, not bearing labeling approved by EPA pursuant to the Agreement (except for the purpose of relabeling according to the 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 propose to revoke the tolerances found in: 40 CFR 180.276 for residues of formetanate hydrochloride in 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 hydrochloride products on plums and prunes. In accordance with the October 14, 1999, Agreement, the Agency intends to revoke these tolerances to help reduce acute dietary risks that currently exceed the margins of safety deemed acceptable by the Agency. The Agency intends that the tolerance revocations become effective June 1, 2000.

VII. Import Tolerance Guidance

The Agency is willing to consider requests to modify or maintain a tolerance following the cancellation of the accompanying registration. Such request should be sent to the person identified in the “FOR FURTHER INFORMATION CONTACT” section. If EPA receives a request to modify or maintain a tolerance in response to this Notice, the Agency will issue a Notice under section 408(f) of FFDCA informing the public of the data required to support the tolerance and stating the time period for submitting the required data. Regardless of whether a tolerance applies solely to domestic food uses or solely to imported foods, the same technical chemistry and toxicology data are required to support tolerances under FFDCA section 408. For pesticide chemicals used in or on food, EPA requires residue chemistry data that are representative of growing conditions in exporting countries in the same manner that the EPA requires representative residue chemistry data from different U.S. regions to support domestic use of the pesticide and the tolerance. Persons supporting the maintenance or modification of tolerances to cover residues in or on imported food have the burden of demonstrating the relevance 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 foods following the cancellation of the registered food use, the Agency will publish in the Federal Register a notice proposing to revoke the tolerance. That notice will again give interested parties the 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.