Benomyl; Cancellation Order

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces a cancellation order for product cancellations requested by E.I. du Pont de Nemours & Company (DuPont) for its registrations of pesticide products containing methyl 1-(butylcarbamoyl)-2-benzimidazole carbamate, or benomyl, and accepted by EPA, pursuant to section 6(f) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). This order follows up a May 23, 2001, notice of receipt of requests for registration cancellations. In that notice, EPA requested comments on the proposed cancellations and indicated that it would issue an order confirming the voluntary registration cancellations. Any distribution, sale, or use of canceled benomyl products is only permitted in accordance with the terms of the existing stocks provisions of this cancellation order.

DATES:

The cancellations are effective August 8, 2001.

FOR FURTHER INFORMATION CONTACT:

By mail: Demson Fuller, Special Review and Reregistration Division (7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460, telephone number: (703) 308-8062; fax number: (703) 308-7042; e-mail address: fuller.demson@epamail.epa.gov.

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 benomyl 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 Home Page at http://www.epa.gov/. To access this document, on the Home Page 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/.

2. In person. The Agency has established an official record for this action under docket control number OPP-66288. 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 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. Receipt of Request to Cancel Registrations

A. Background

Benomyl is a benzimidazole carbamate and systemic foliar fungicide registered for use on almonds, apples, anise, apricots, asparagus, avocado, banana, barley, bean vine, blueberries, brassica (broccoli, Brussels sprouts, cabbage, chicory, chinese cabbage, cauliflower, collards, kale, kohlrabi, mustard greens, rutabagas, and turnips), caneberries (raspberries, blackberries, boysenberries, loganberries, and dewberries), cardoon, carrots, celery, cherries, citrus, conifers, corn, cucurbits (cucumber, melons, pumpkins, and squash), currants, dandelions, dill, figs, grapes, macadamia nuts, mangoes, mushrooms, nectarines, onions, oats, papayas, peaches, peanuts, pears, peas, pecans, peppers, pineapple, pistachio, plums, prunes, rape, rice, rye, soybeans, spinach, strawberry, sugar beets, tomatoes, wheat, and yams.

Dupont met with the Agency on April 18, 2001, and requested a voluntary cancellation of all their registrations for products containing benomyl, to be effective December 31, 2001. Dupont stated that this decision was based on business reasons. They submitted this request in writing in a letter dated April 18, 2001. On May 1, 2001, Dupont submitted a second letter requesting that the effective date of cancellation be moved from December 31, 2001, to May 1, 2001. EPA noted that it could not grant a cancellation request until the requisite public comment period expired and EPA had considered public comments received.

Pursuant to section 6(f)(1) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA announced receipt of this request from Dupont in a Federal Register notice published on May 23, 2001 (66 FR 28466) (FRL-6784-3). In that notice EPA provided a 30-day comment period. Dupont requested that the Administrator waive the 180-day comment period provided under FIFRA section 6(f)(1)(c), and EPA granted this request.

Public comments were received from seven interested parties:

The American Mushroom Institute is concerned with the loss of benomyl due to its effectiveness controlling diseases such as green mold. They would like for the Agency to assist them in registering effective alternatives.

The Arizona Department of Agriculture would like for Dupont to dispose of any benomyl products that dealers have in stock after the proposed December 31, 2002, termination of sales date for products in the channels of trade. They also have concerns for users who may have excess benomyl and would like Dupont to dispose of their products as well.

The California Pistachio Commission is concerned with the timing for tolerance revocation. They fear that growers may purchase excess stocks of benomyl and not have adequate time to exhaust their benomyl supplies and allow for treated pistachios to clear the channels of trade before tolerances are revoked. They ask EPA to delay tolerance revocation until 2007.

A blueberry grower in Michigan, as well as the Michigan Blueberry Growers Association, commented on the need for effective materials to control diseases such as canker, botrytis, anthracnose, and alternaria on blueberries. The Michigan Blueberry Growers Association is also concerned over the timing for tolerance revocation.

The U.S. Apple Association commented that growers of both apples and pears will need new products to control various diseases currently controlled by benomyl. They are concerned with the high costs associated with certain benomyl alternatives, and that increased use of less-expensive alternatives may lead to resistance problems. The U.S. Apple Association also asks that EPA delay tolerance revocation for 4 years after cancellation to ensure apple products clear the channels of trade.

Finally, a consulting firm objected to Dupont's request to waive the 180-day comment period because the unexpected request for cancellation has the potential to cause financial loss to other registrants working with, or preparing to work with benomyl. Because “me-too” applications for registrations of a generic off-patent product require the active registration of a substantially similar product, this firm holds that Dupont has eliminated the opportunity for other registrants to apply for and obtain benomyl product “me-too” registrations. The effect of this, they say, is that generic registrants will lose investments they may have made in pursuing such registrations.

In response to this last comment, EPA notes that FIFRA allows applicants who have submitted their applications before the voluntary cancellation has occurred to use the data submitted by the original data submitter as long as data compensation requirements are fulfilled. EPA acknowledges that Dupont's decision may affect the business opportunities of other pesticide manufacturers who wish to register new benomyl products, and that waiving the 180-day comment period reduces the window of opportunity for submission of “me-too” applications for registration. At the time Dupont requested the voluntary cancellations, it had already ceased production of benomyl. FIFRA section 6(f)(1)(C) states that EPA may waive the 180-day comment period upon the request of the registrant. The Agency believes, that this provision was intended to give ample time for EPA to hear from growers the potential impact of the requested cancellations on agriculture. EPA, in coordination with the U.S. Department of Agriculture, has communicated with representatives of commodity groups for the crops on which benomyl is registered to: Inform them of the requested cancellation, summarize the Federal Register notice announcing the requested cancellation, ascertain the potential impacts on Agriculture of the requested cancellations, and encourage affected parties to submit comments during the 30-day comment period on the proposed cancellations. For these reasons, EPA decided that it was appropriate to grant Dupont's request to waive the 180-day comment period as provided for by FIFRA section 6(f)(1)(C).

In response to comments on the timing for tolerance revocation, EPA is concerned with growers purchasing excess amounts of benomyl. Because this action is not due to risk issues, EPA is not setting a last legal use date, but, EPA believes that use of existing stocks of these products will likely end in 2003, given that the registrant ceased production of technical product around April 2001, and that no sale or distribution of product may occur after December 31, 2002. EPA will determine how long treated food containing residues of benomyl could remain in the channels of trade assuming that treatment last occurs on December 31, 2003, and will set the tolerance revocation dates accordingly.

In response to the comments on the need for reasonable disposal of benomyl, EPA recommends that distributors purchase reasonable supplies to avoid excess stocks. EPA notes that Dupont, in a letter dated July 6, 2001, has offered to receive product for the purpose of disposal from dealers and distributors following December 31, 2002, and from users following December 31, 2003. Dupont will dispose of these products at no cost to anyone willing to ship the products to a designated Dupont facility.

In response to comments on the need for alternative materials to replace benomyl, EPA is aware of the importance of benomyl to growers. The Agency is committed to working with industry to identify and make available suitable alternatives to control diseases on mushrooms, blueberries, apples, pears, and other crops. Also, EPA continues to expedite new fungicides through its reduced risk initiative which shortens the time required to register new chemicals and uses.

B. Requests for Voluntary Cancellation of Products

Pursuant to FIFRA section 6(f)(1)(A), Dupont has submitted requests for voluntary cancellation of registrations for their products containing benomyl. The registrations for which cancellations were requested are identified in the following Table 1:

III. Cancellation Order

Pursuant to section 6(f)(1)(A) of FIFRA, EPA is approving the requested registration cancellations. Accordingly, the Agency orders that the registrations identified in Table 1, are hereby canceled. Any distribution, sale, or use of existing stocks of the products identified in Table 1, in a manner inconsistent with the terms of this Order or the Existing Stock Provisions in Unit IV of this Federal Register 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

For purposes of this Order, the term “existing stocks” is defined, pursuant to EPA's existing stocks policy 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 cancellation.

A. Distribution or Sale by the Registrant

The distribution or sale of existing stocks by registrants will not be lawful under FIFRA after August 8, 2001, 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.

B. Distribution and Sale by Other Persons

Sale or distribution by any person of existing stocks of any products identified in Table 1, will not be lawful under FIFRA after December 31, 2002.

V. Notification of Intent to Revoke Tolerances

This notice also serves as an advance notification that the Agency intends to revoke the related tolerances, for the cancelled registrations listed in this notice, unless there is a request from the public to support the tolerances for import purposes. EPA believes that the end use of any remaining existing stocks of these products will likely end in 2003 given that production of technical product by the registrant ceased around April 2001 and that sale and distribution of benomyl products will end on December 31, 2002. EPA will determine how long treated food containing residues of benomyl could remain in the channels of trade assuming that the last treatment occurred on December 31, 2003, and will set the expiration date accordingly.

It is EPA's general practice to propose revocation of tolerances for residues of pesticide active ingredients for which FIFRA registrations no longer exist, to protect the food supply of the U.S. and to discourage the misuse of pesticides within the United States. In many cases the cancellation of a food use in the U.S. indicates that there are insufficient domestic residue data or other information to support the continuation of the tolerance and an uncertain amount of relevant data concerning residues on imported food. In the absence of relevant data, EPA is unable to make a safety finding regarding the treated food entering the U.S. Upon request, EPA will provide interested parties with its import tolerance policy and data requirements, explaining how an interested party should go about seeking to retain a tolerance for import purposes.

List of Subjects

• Environmental protection
• Pesticides and pests