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Fenridazone Potassium TRED Facts

This fact sheet serves as and explains EPA's tolerance reassessment eligibility decision (TRED) for fenridazone potassium, which consists of a voluntary voluntary cancellation of this pesticide. Fenridazone potassium was scheduled for tolerance reassessment in 2003; however, during 2003, the registrants of fenridazone requested voluntary cancellation. The following provides background information on pesticide registration, reregistration, and tolerance reassessment, an overview of the uses and health effects associated with fenridazone, and a summary of the terms of its cancellation. Because of the voluntary cancellation decision, EPA did not complete risk assessments for fenridazone potassium and will not issue a TRED document for this pesticide.

Pesticide Registration and Reregistration

All pesticides sold or distributed in the United States must be registered by EPA, based on scientific studies showing that they can be used without posing unreasonable risks to people or the environment. Because of advances in scientific knowledge, the law requires that pesticides which were first registered before November 1, 1984, be reregistered to ensure that they meet today's more stringent standards.

To implement provisions of the Food Quality Protection Act of 1996 (FQPA), EPA considers the special sensitivity of infants and children to pesticides, as well as aggregate exposure of the public to pesticide residues from all sources, and the cumulative effects of pesticides and other compounds with common mechanisms of toxicity. The Agency develops any mitigation measures or regulatory controls needed to effectively reduce each pesticide's risks. EPA then reregisters pesticides that meet the safety standard of the FQPA, and can be used without posing unreasonable risks to human health or the environment.

Tolerance Reassessment Decisions

EPA issues a TRED (Tolerance Reassessment Eligibility Decision) for a pesticide that requires tolerance reassessment decisions, but does not require a reregistration eligibility decision at present because: (1) the pesticide was initially registered after November 1, 1984, and by law is not included within the scope of the reregistration program; (2) EPA completed a RED for the pesticide before FQPA was enacted on August 3, 1996; or (3) the pesticide is not registered for use in the U.S. but tolerances are established that allow crops treated with the pesticide to be imported from other countries. TREDs for pesticides that are part of a cumulative group, such as the organophosphates, will not become final until EPA considers the cumulative risks of all the pesticides in the group.

Background

Fenridazone Potassium was first registered in 1985. On May 20, 2003, Monsanto requested voluntary cancellation of its fenridazone registration and product Hybrex 2LC Chemical Hybridizing Agent, (EPA Reg. No. 524-453.) EPA published a Federal Register Notice on July 25, 2003 (Federal Register Notice, OPP-2003-0231; FRL-7315-6), announcing receipt of Monsanto's request for cancellation and inviting the public to comment during the next 30 days. The Agency did not receive any comments and on November 5, 2003, the cancellation of the fenridazone potassium registration became effective.

Uses

Fenridazone potassium was used as a plant growth regulator to produce hybrid wheat. The product was formulated as a liquid concentrate and mixed with water and a surfactant, and applied at 0.5 to 2.5 lb. active ingredient per acre.

Health Effects

Based on toxicity data submitted for registration, the compound does not appear to be teratogenic, fetotoxic, carcinogenic, or mutagenic, and has minimal effects on reproduction, with decreased pup survival at very high doses. No appropriate effects attributed to a single exposure were identified in any study including the rat or rabbit developmental toxicity studies.

Tolerances

Tolerances or maximum residue limits for fenridazone are located at 40 CFR 180.423. There are 32 tolerances that exist for food and feed items such as wheat, meat, milk, and eggs. EPA anticipates publishing an FR notice proposing the revocation of tolerances for fenridazone in the near future. EPA will make a final decision regarding tolerance revocation after considering public comments on the proposal.

Regulatory Conclusion

1. The registrant, Monsanto Company, which held the fenridazone potassium registration requested cancellation under FIFRA section 6(f), of that product containing fenridazone potassium as an active ingredient. EPA granted this cancellation request after a 30-day comment period following the publication of the 6(f) notice in The Federal Register.

2. Cancellation orders generally permit a registrant to sell or distribute existing stocks for 1 year after the date of cancellation request was received . However, the fenridazone potassium product has not been sold since 1989; therefore, no products should be in the channels of trade.

For More Information EPA is making this Reregistration Eligibility Decision (RED) Fact Sheet for fenridazone potassium available, as announced in a Notice of Availability published in the Federal Register. To obtain a copy of the Fact Sheet or to submit written comments, please contact the Pesticide Docket, Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), US EPA, Washington, DC 20460, telephone 703-305-5805.

Electronic copies of this RED Fact Sheet are available on the Internet. See Pesticide Reregistration Status. Printed copies of the RED fact sheet can be obtained from EPA's National Service Center for Environmental Publications (EPA/NSCEP), PO Box 42419, Cincinnati, OH 45242-2419, telephone 1-800-490-9198; fax 301-604-3408.

Following the comment period, the fenridazone potassium RED Fact Sheet also will be available from the National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161, telephone 1-800-553-6847, or 703-605-6000.

For more information about EPA's pesticide reregistration program, the fenridazone potassium RED, or the status of individual products containing fenridazone potassium, please contact the Special Review and Reregistration Division (7508C), OPP, US EPA, Washington, DC 20460, telephone 703-308-8000.

For information about the health effects of pesticides, or for assistance in recognizing and managing pesticide poisoning symptoms, please contact the National Pesticide Telecommunications Network (NPTN). Call toll-free 1-800-858-7378, from 6:30 am to 4:30 pm Pacific Time, or 9:30 am to 7:30 pm Eastern Standard Time, seven days a week. Their internet address is ace.orst.edu/info/nptn Exit EPA disclaimer.

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