EPA Pesticide Program Update from EPA's Office of Pesticide Programs 07/11/01
http://www.epa.gov/pesticides
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IN THIS UPDATE:
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1) EPA RELEASES FINAL PESTICIDE REGISTRATION
(PR) NOTICE TO ELIMINATE PHENOL RESISTANCE TESTING
On June 29, 2001, EPA issued the final Pesticide Registration (PR) Notice eliminating phenol resistance testing from the efficacy tests performed on antimicrobial disinfectant and sanitizer pesticides. A Notice of Availability of the PR Notice was published in the Federal Register on June 29th. EPA is eliminating this testing requirement after determining that the test's unreliability and cost outweighed the minimal benefit derived from the test data, and that it will still be able to make the necessary safety and efficacy determinations without the phenol test data.
Before making this decision, the Agency consulted with the Scientific Advisory Panel (SAP) and reviewed its recommendation to eliminate, modify, or redirect the use of phenol resistance testing for antimicrobials. The Agency also discussed the issue with members of the scientific and regulated communities who agreed that (1) the phenol coefficient method has been un-satisfactory for evaluating the sensitivity of certain micro-organisms used during disinfectant efficacy testing and (2) the resistance assay does not mimic the test systems in the current efficacy methods.
Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), antimicrobial disinfectant and sanitizer pesticides must undergo certain efficacy testing before the Agency will approve the registration of such products. Phenol resistance testing has traditionally been used to estimate the resistance or sensitivity of some test bacteria to chemical disinfectants and sanitizers. However, the difficulty in ensuring standardized performance in phenol resistance tests has been a recognized scientific problem for many years. Additionally, the inability of many reputable and competent testing facilities to achieve consistent test results with the phenol resistance standard has prompted both concern and this action by the Agency.
The PR Notice (PR Notice 2001-4) announcing this decision may also
be found on EPA's website at
http://www.epa.gov/opppmsd1/PR_Notices/. or
http://www.epa.gov/opppmsd1/PR_Notices/pr2001-4.pdf
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2) EPA, FDA, AND STATE PARTNERS RESPOND TO MISUSE OF PESTICIDE
Since early June, EPA and the Food and Drug Administration (FDA), in cooperation with EPA Regional Offices, the U.S. Department of Agriculture (USDA), and State regulatory officials, has been investigating incidents in which the restricted use pesticide zeta-cypermethrin (registered by FMC under the trade names Fury and Mustang) was illegally applied to 6,458 acres of wheat in Arkansas and 18,271 acres in Mississippi. Possible misuse of the compound on other crops in Tennessee is also being investigated at this time.
Zeta-cypermethrin is not registered for use on wheat and no wheat tolerances are established, so any detectable residues on wheat would make a treated crop adulterated. State agencies have detected residues on some of the treated wheat well above the existing tolerance for zeta-cypermethrin on cotton. EPA has been working closely with Federal and State officials to determine the dimensions of the misuse, to coordinate a response within EPA and with the other concerned federal agencies, and to work with States and regional and field offices of FDA to make sure the adulterated wheat does not enter commerce.
On June 11th, EPA and FDA issued a joint letter to EPA Regions and the States for distribution to farmers warning them not to move the contaminated wheat into the market or feed it to animals.
On Thursday, June 14th, EPA, FDA, and State officials signed an agreement with the registrant of zeta-cypermethrin whereby the registrant agreed to: (1) notify all affected growers of the company's plans to purchase their adulterated wheat; (2) purchase all wheat from the growers identified by the State regulatory officials; (3) notify FDA and EPA immediately of growers refusing to sell their adulterated wheat; (4) monitor the harvest to ensure that the adulterated wheat does not enter interstate commerce; (5) store the wheat in segregated and secured facilities (either on growers' farms or in contracted commercial facilities);and, (6) be responsible for ensuring that this wheat not be released into interstate commerce unless and until FDA, in consultation with EPA and USDA, provides clearances following review of testing results generated by using FDA-approved methods. EPA has concluded that the residues of zeta-cypermethrin in/on wheat and its processed commodities do not pose a dietary risk once the levels in the raw agricultural commodity (RAC) fall below the detection limit of 0.02 ppm. EPA informed FDA of its determination in a letter on June 14th.
On June 25, EPA briefed officials of the State FIFRA Issues Research and Evaluation Group (SFIREG)on the Fury misuse situation. In response, the SFIREG committee drafted and unanimously passed a resolution supporting vigorous federal and state enforcement actions against any parties involved in misuse of pesticides on food crops. SFIREG was established through a cooperative agreement in 1978 by EPA and the Association of American Pesticide Control Officials (AAPCO) to exchange information between EPA's Office of Pesticide Programs and State regulatory officials.
SFIREG RESOLUTION
In view of the potential adverse consequences to the nation's food supply as a result of illegal pesticide use, and the desire of the state and federal regulatory agencies to ensure full compliance with state and federal pesticide law:
By resolution:
SFIREG (State-FIFRA Issues Research and Evaluation Group) strongly supports the vigorous and full investigation of possible violations of state and/or federal pesticide control law, and specifically the current investigation into the alleged misuse of Fury insecticide on wheat.
SFIREG also strongly supports and encourages the full prosecution of any person or company found to be a party to such misuse, including any grower, certified or licensed applicator, crop consultant or other agronomic advisor, pesticide product distributor, or pesticide product registrant involved in such illegal activity.
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EPA distributes its Pesticide Program Updates to external stakeholders and citizens who have expressed an interest in O.P. activities and decisions. We have established an electronic list serve for people who want to keep abreast of pesticide issues and decisions. This update service is part of EPA's continuing effort to improve public access to Federal pesticide information.
For general questions on pesticides and pesticide
poisoning prevention, contact the National Pesticide
Telecommunications Network (NPTN), toll-free, at:
1-800-858-7378, by E-mail at nptn@ace.orst.edu,
or by visiting their website at:
http://ace.orst.edu/info/nptn/
For information about ongoing activities in the
Office of Pesticide Programs, visit our homepage
at: http://www.epa.gov/pesticides
Or call or write us directly at:
Communication Services Branch
Office of Pesticide Programs (7506C)
US Environmental Protection Agency
Ariel Rios Building
1200 Pennsylvania Avenue, NW
Washington, DC 20004-2403
703-305-5017