01-21200. Vinclozolin; Notice of Use Cancellations

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces use cancellations as requested by BASF Corporation for its registrations containing 3-(3,5-dichlorophenyl)-5-ethenyl-5-methyl-2,4-oxazolidinedione), or vinclozolin, pursuant to section 6(f) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). This Notice follows up a September 20, 2000, Notice of receipt of requests to delete these uses from vinclozolin registrations, and to terminate use and sale for these uses by certain dates. This Notice also requested comments on these use deletions and dates for end of sale and use. EPA has considered the comments received and has modified the schedule of end of sale and use dates accordingly. 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 cancellations are effective August 22, 2001.

FOR FURTHER INFORMATION CONTACT:

By mail: Deanna Scher, 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 vinclozolin 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/​. To access information about the risk assessment and Reregistration Eligibility Decision for vinclozolin, go to the Home Page for the Office of Pesticide Programs, or go directly to http://www.epa.gov/​pesticides/​reregistration/​vinclozolin/​.

2. In person. The Agency has established an official record for this action under docket control number OPP-66290. 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 [phone].

II. Receipt of Requests to Amend Registrations to Delete Uses

A. Background

Vinclozolin (trade names Curalan, Ronilan) is a fungicide first registered in 1981 to control various types of rot caused by Botrytis spp., Sclerotinia spp, and other types of mold and blight causing organisms on various agricultural crops, ornamental plants, and turf. BASF, the technical registrant of vinclozolin, petitioned EPA to establish tolerances for residues of the fungicide vinclozolin and its metabolites containing the 3,5-dichloroanaline moiety in or on canola and succulent beans (April 21, 2000, 65 FR 21427) (FRL-6555-6). However, EPA was unable to make the “reasonable certainty of no harm” finding mandated by section 408(b)(2) of the Federal Food, Drug, and Cosmetic Act (FFDCA) for succulent beans and canola use and associated tolerances if all existing uses remained in place. In addition to dietary risks of concern, the Agency identified risk concerns for occupational workers in the ornamental industry in part due to the potential for long-term exposure and a risk of concern for children playing on transplanted sod previously treated on a sod farm.

Therefore, to reduce the risk posed by exposure to vinclozolin, and thereby enable the Agency to make a “reasonable certainty of no harm” finding for succulent beans and canola and the related tolerances, on May 31, 2000 BASF requested the immediate voluntary cancellation of use on raspberries onions and ornamentals, phase-out over the following 4 years of all other domestic food uses of vinclozolin except canola, and the revocation of all import tolerances except for wine grapes to permit the importation of wine containing residues of vinclozolin. BASF also requested that EPA modify use of vinclozolin on turf. The cancellations were conditioned on EPA reestablishing the expired tolerance for vinclozolin use on succulent beans and granting a new tolerance associated with a canola registration. The cancellations were also conditioned on EPA accepting certain existing stock provisions.

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)(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 the registrants request a waiver of the comment period, or the Administrator determines that continued use of the pesticide would pose an unreasonable adverse effect on the environment. The registrant requested that EPA waive the 180-day comment period. In light of this request, EPA granted the request to waive the 180-day comment period, and a 30-day comment period was allowed.

EPA announced these use cancellation and amendment requests in a Federal Register Notice (September 20, 2000, 65 FR 56894) (FRL-6744-2) and asked for public comments. In response, public comments were received from three interested parties. The Scotts Company remarked that it will be difficult for distributers and retailers to manage inventory based on the Agency's proposed last legal use date being concurrent with the last date for sale and distribution. Scotts also requested that the last legal use date be extended for ornamentals based on the difficulties associated with canceling use during the middle of the normal use period for one of the largest ornamental markets. The National Onion Association expressed concern that alternatives to vinclozolin may be more costly and less effective. The Association also argued that registration of newer, safer alternatives should be expedited and that growers in foreign countries could use vinclozolin on onions for export to the U.S. and thereby gain an unfair advantage over U.S. growers. Weyerhaeuser Corporation argued against the use cancellation of vinclozolin for forestry seedlings grown in greenhouses and nurseries based on convincing evidence that there is a lack of alternatives for this use. Weyerhaeuser also provided information about the handler and re-entry exposure and use practices for coniferous forest tree species in greenhouses.

Reviewing and responding to the comments and additional information submitted by Weyerhaeuser required substantial resources and time. Consequently, the dates originally proposed for “last date for sale and distribution of existing stocks” for onions, raspberries, and ornamentals have passed. In order to obviate any confusion or difficulty this may cause those entities affected by this action, the last date for sale and distribution of existing stocks for onions raspberries, and ornamentals has been extended from January 1, 2001 to August 30, 2001.

In response to comments provided by the Scotts Company, EPA has amended the previously proposed time frames by designating separate dates for sale and distribution and for last legal use. Although this amendment slightly extends the time frames for last legal use, the change is considered minimal as the new dates do not exceed 2 or 3 months past the original dates established for last legal use. In addition, the extension of the last sale dates for the product bearing the ornamentals use until October 15, 2001 will also address Scott's concerns by allowing sales through the end of the seasonal use period as defined by Scotts.

In response to National Onion Association comments, EPA is also concerned about the availability of alternatives to vinclozolin but believes there are less risky fungicides available. EPA also continues to expedite new fungicides through its Reduced-Risk Initiative, which significantly shortens the time required to register commercially viable alternatives to pesticides with risks of concern, and is currently working on registration of a vinclozolin alternative through this effort. Also, while foreign growers may use vinclozolin in the near term on onions for export into the U.S., EPA intends to propose revocation of tolerances for vinclozolin on all canceled uses as soon as it can be reasonably expected that domestic use has ceased (i.e., the last legal use date has passed). Revocation of tolerances will make the importation of such vinclozolin treated commodities unlawful. In accordance with FFDCA section 408(l)(2), EPA will revoke the tolerances within 180 days of last legal use. Commodities legally treated will be allowed in the channels of trade past the last date of legal use in accordance with FFDCA section 408(l)(5).

Finally, to address the concerns raised by Weyerhaeuser, EPA is allowing the sale, distribution, and use of vinclozolin on coniferous forestry seedlings for an additional 2 years. However to mitigate risks to re-entry workers, a 12-day restricted entry interval will be required. However, EPA will allow exceptions to the restricted entry interval after 3 days for irrigation and after 7 days for weeding and scouting. These use changes have been made to the Curalan EG formulation (EPA Reg. No. 7969-85) as a supplemental label for this registration. The supplemental label will allow use until August 30, 2003.

B. Requests for Voluntary Amendment and Cancellation

Pursuant to FIFRA section 6(f)(1)(A), BASF submitted requests for voluntary cancellation and use amendment of the registrations for vinclozolin. Specifically, BASF requested that EPA immediately amend registration number 7969-85 (Ronilan, Curalan, Touche) to terminate the use of vinclozolin on onions, raspberries, and ornamental plants.

EPA has considered the public comments received as detailed above in section II.A. and the timing of this Notice, and has modified the time frames for use cancellation and existing stocks from that published in the original proposal. These changes are reflected in the following Table 1.

Table 1.—Time Frame for Use Cancellation and Existing Stocks Provision

Commodity	Date of Registrant Use Cancellation Request	Last Date for Sale and Distribution of Existing Stocks by Registrant	Last Date for Sale and Distribution of Existing Stocks by Others	Last Date for Legal Use
Onions	July 15, 2000	August 30, 2001	October 15, 2001	December 15, 2001
Raspberries	July 15, 2000	August 30, 2001	October 15, 2001	December 15, 2001
Ornamentals (except conifer seedlings)	July 15, 2000	August 30, 2001	October 15, 2001	December 15, 2001
Conifer seedlings	July 15, 2000	August 30, 2003	October 15, 2003	December 15, 2003
Kiwi	December 31, 2001	December 31, 2002	November 30, 2003	January 30, 2004
Chicory	December 31, 2001	December 31, 2002	November 30, 2003	January 30, 2004
Lettuce	July 15, 2004	July 15, 2005	September 30, 2005	November 30, 2005
Succulent Beans	July 15, 2004	July 15, 2005	September 30, 2005	November 30, 2005

III. Cancellation Order

Pursuant to FIFRA section 6(f)(1)(A), EPA hereby grants the requested voluntary use cancellations and amendments of the registrations for vinclozolin as described in this Notice. Accordingly any distribution, sale, or use of existing stocks of 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 Provision

Pursuant to section 6(f) of FIFRA, EPA is granting the requests for voluntary amendment and cancellation during the appropriate time frames identified in Table 1. For purposes of the cancellation order, the term “existing stocks” will be defined, pursuant to EPA's existing stocks policy at (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. Any distribution, sale, or use of existing stocks after the effective date of the cancellation order 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.

The distribution or sale of existing stocks by registrants will not be lawful under FIFRA after the sale and distribution dates for registrants listed in Table 1, 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. Retailers and distributors may sell or distribute products with previously approved labeling which have been released for shipment until such supplies are exhausted, or until the date specified for “Sale and Distribution by Others” as presented Table 1, whichever comes first. End-users may use products with previously approved labeling until such supplies are exhausted or until the last legal use date listed in Table 1, whichever comes first.

List of Subjects

• Environmental protection
• Pesticides and pests

Dated: August 10, 2001.

Jack E. Housenger,

Acting Director, Special Review and Reregistration Division, Office of Pesticide Programs.