Registration Statijs of Vertebrate Pesticides with Emphasis on 1080 and Strychnine

REGISTRATION STATIJS OF VERTEBRATE PESTICIDES WITH EMPHASIS ON 1080 AND STRYCHNINE STEVE D. PALMATEER, Insecticide-Rodenticide Branch, Registration Division, Office of Pesticide Programs, U.S. Environmental Protection Agency, Washington D.C. ABSlRACT: A review of currently registered vertebrate pesticides is reported with by far the major weight given to strychnine and 1080. The author searched the Agency's label files and has listed most of those pesticides that have claims against at least one vertebrate animal. Proc. 14th Vertebr. Pest Con(. (LR. Davis and R .E. Marsh, Eds.) Published at Univ. of Calif., Davis. 1990. INTRODUCTION (Table 1) . These are pesticides registered under Sections 3 The purpose of this paper is to report on the current and 24 of the Federal Insecticide, Fungicide, and Rodenticide status of those active ingredients that purport some pesticidal Act (FIFRA). Also included were products that were used activity against vertebrate pests. At one time the Agency had only within state boundaries prior to 1972 (i.e., Intra-State in its files 1,583 labels on at least 85 vertebrate pesticides Products used under 40 CFR 162.17). Table 1. Llst of chemicals that have been listed as an active ingredient on at least one vertebrate pesticide label. Note that some of these vertebrate pesticides are no longer in use or the Agency has determined they should not be considered active ingredients. Chemical Chemical Chemical Acetophenone DDT Phosphorus Ally! isothiocyanate Diphacinone Alpha-pinene Alpha-chlorohydrin Diphacinone sodium salt Pival Aluminum phosphide Pival, calcium salt Endrin 4-aminopyridine (Avitrol) Pival, sodium salt ~ntial oils Anticycin A PMP Antimony potassium tartrate Fenthion Polybutenes ANTU Fumarin Putrescent whole egg solids Arsenious oxide (arsenic trioxide) Fumarin, sodium salt of R-55 Barium carbonate Geranium oil Red squiU Bayluscide Gophacide Rotenone Biomet 12 Lavender oil Bitrex (Benzyl diethyl ammonium) Soap Lemongrass oil Sodium cyanide (M-44) Blood (dried) d-limonene Starlicide Bone tar oil (bone oil) lindane (bird control use only) Strychnine alkaloid Brodifacoum Strychnine sulfate Bromadiolone Magnesium phosphide Sulfaquinoxaline Bromethalin Mesurol (Methiocarb) Methyl bromide Talon (Brodifacoum) Capsaicin Methylene chloride Carbon disulfide TFM Methyl nonyl ketone Tbalium sulfate Castor oil, hydrogenated Mineral oil Tobac.co dust Chlorophacinone Mustard oil Tri-n butyltin Cholecalciferol Thiram Cinnamaldehyde Naphthalene (repellent use only) Tbymol Citral Nicotine sulfate Citronella oil Norbormide Warfarin Coconut oil Warfarin sodium salt Omitrol Compound 1080 Zlnc phosphide Compound 1081 PA-14 Ziram Copper naphthenate Pardichlorobenzene 113 Starting in 1988 the list of vertebrate pesticides started to Also, as clearly required under the FIFRA, the responsibility shrink somewhat with the call-in of the intra-state products. for establishing the safety and efficacy of both of these This meant that the owners of these products were required vertebrate pesticides rests with the registrant and not with the to submit an application for a section 3 registration and the Agency. A complete data base for both strychnine and 1080 registration had to be supported by data. FIFRA, as had not been generated, in large part because of the amended in 1988, required registrants to pay maintenance fees uncertain registration status of the pesticides. starting in 1989. In 1989 this fee was $425 per registered The Agency has issued three Data Call-In (DCI) Notices product up to 50. When the total bill reaches $20,000, the for rodenticidal uses for strychnine and two for Compound registration fee drops to $100 for each additional registered 1080. EPA required that all products be supported by data product until the total bill reaches the maximum limit of necessary for registration under section 3. These actions were $35,000. This year the maintenance fee is $1,300 per product taken under the authority of FIFRA section 3(c)(2)(B) based (except the first product is $650). Section 4 of FIFRA on the determination that the additional data were needed to authorizes the administrator of the Agency to adjust the support the continued registration of both strychnine and maintenance fee so that the Agency will realize an aggregate Compound 1080 products. amount of $14 million. If these fees are not paid, the The Agency required product chemistry, environmental administrator may cancel a registration "by order and without fate chemistry, toxicology, and wildlife and aquatic organism hearing." Therefore if there is a net loss in the number of testing. The Agency also requested the development of registrations, the co.5t of the maintenance fees may increase tolerances for these products if there is foliar contact of the the next year. Reregistration of vertebrate pesticides al.so pesticide with a food or feed crop, uptake of the pesticide in contributed to the decline in the number of products. While a food or feed crop from the soil, or direct contact of the the scope of data requirements was kept to an absolute pesticide with a livestock animal (e.g., dermal contact or minimum in order to permit Agency scientists to make ingestion of treated bait), in which case the application is a judgments relevant to the safety and efficacy of a pesticide food use, and food use requirements will apply. Under these product, some registrants did not feel that the co.5ts of data circumstances, a petition for tolerance or a petition for generation would justify continued registration. Registrants exemption from the requirement of a tolerance is required to who are slow to submit required data can have their product support registration. As a result of the requirements, all registrations suspended from further sale and distribution until registrants revised their labels to reflect nonfood uses to avoid the required data is supplied to the Agency. Suspended the tolerance requirement. products are subject to the maintenance fees! EPA reviewed the data requirements very carefully before issuing the DCI documents. EPA feels that the requirements STRYCHNINE AND 1080 were lcept to an absolute minimum to avoid unnecessary data The Rebuttable Presumption Against Registration gathering ~ts and yet at the same time to provide adequate (RPAR) notice (now called Special Review) for 1080 and data in order to make a scientific regulatory judgment about strychnine was published in the FEDERAL REGISTER of the risks and benefits of Compound 1080 and strychnine. December 1, 1976. The presumption was against all outdoor Several registrants requested waivers and/or postponement of above-ground uses of strychnine and all uses of Compound data requirements and presented persuasive rationales why the 1080. Three other actions by the Federal government should waivers should be granted enabling the Agency to grant these be noted. In March 1972, Executive Order 11643 was issued. requests. This order prohibited the use of all toxicants, including In October 1985 and again in October 1987, EPA sent strychnine, for control of predators on federal lands or in a group of its scientists and other staff to public meetings in federal programs. Additionally, in February 1978 the Agency Denver, Colorado, to explain why the data were needed, how restricted products of several active ingredients, including the data should be generated, and describe the standard strychnine formulations with concentrations greater than 0.50 format for data submitted under FIFRA The Agency al.so percent, for use only by certified applicators. The criteria sent its vertebrate pest biologists to a meeting of the influencing the restriction for strychnine were significant acute strychnine registrants held in conjunction with the Thirteenth oral toxicity, apparent hazards to nontarget species, and the Vertebrate Pest Conference in Monterey, California, in March results of use and accident history. 1988. The most important development at this meeting was The RPAR criteria that were determined to have been the formation of the strychnine data-gathering consortium met or exceeded for the outdoor above-ground uses of headed by the U.S. Department of Agriculture, Animal and strychnine and all uses of Compound 1080 were: 1) acute Plant Health Inspection Service, Animal Damage Control toxicity to mammals and birds, and 2) significant reduction in (USDNAPHIS/ADC). From the beginning of the strychnine populations of nontarget organisms and fatalities to members consortium, the Agency has attempted to be helpful to the of endangered species. group (e.g., supplied names and addresses of all strychnine Position Document 2(3 (PD 2(3), which detailed the registrants, clarified many of the data requirements, reviewed Agency's decision on strychnine, was published for comments hundreds of protocols, and made hundreds of determinations in November 1980, and in June 1983 for Compound 1080. of data applicability from one registrant to another). In these documents, EPA proposed cancellation of many of the uses for both of these vertebrate pesticides or at least STRYCHNINE modification in terms of use. The Agency received numerous In spite of efforts by EPA, USDNAPHIS/ADC, and comments on the PD 2(3 documents. The most common others to facilitate the strychnine data-gathering process, it criticism was that the Agency had very little definitive data to became apparent in October 1988 that the strychnine data support its conclusions. The Agency felt that its worldwide requirements were not going to be satisfied in a timely literature search had yielded enough data to provide a basis manner. Therefore, on October 6, 1988, the Agency sent for concern about potential risks to nontarget organisms. Notices of Intent to Suspend to all strychnine registrants for 114 failing to submit product chemi.\try and/or failing to show provides the exclusive means of cancelling pesticide significant progr~ towards satisfying the wildlife safety registrations. However, the Endangered Species Act (ESA) efficacy data requirements. Notices of Intent to Suspend were contains a citiun suit provision which allows private citizens sent to 99 companies with a total of 383 products suspended to sue EPA to seek to enjoin violations.

Load more