United States Pre v ention, P esticides EP A 738-R-95-025 En vironmental Protection And T o xic Substances September 1995 Agency (7508W) 

# Reregistration Eligibility Decision (RED) 

# Sodium Fluor oacetateUNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES

CERTIFIED MAIL

Dear Registrant: I am pleased to announce that the Environmental Protection Agency has completed its reregistration eligibility review and decisions on the pesticide chemical sodium fluoroacetate. The enclosed Reregistration Eligibility Decision (RED) contains the Agency's evaluation of the data base of this chemical, its conclusions of the potential human health and environmental risks of the current product's use, and its decisions and conditions under which this use and products will be eligible for reregistration. The RED includes the data and labeling requirements for products for reregistration. It may also include requirements for additional data (generic) on the active ingredients to confirm the risk assessments. To assist you with a proper response, read the enclosed document entitled "Summary of Instructions for Responding to the RED". This summary also refers to other enclosed documents which include further instructions. You must follow all instructions and submit complete and timely responses. **The first set of required responses are due 90 days from the date of this letter.**  **The second set of required responses are due 8 months from the date of this letter.**  Complete and timely responses will avoid the Agency taking the enforcement action of suspension against your products. If you have questions on the product specific data requirements or wish to meet with the Agency, please contact the Special Review and Reregistration Division representative Frank Rubis at (703) 308-8008. Address any questions on required generic data to the Special Review and Reregistration Division representative Leonard Ryan at (703) 308-8067. Sincerely yours,

Lois Rossi, Director Special Review and Reregistration Division Enclosures**SUMMARY OF INSTRUCTIONS FOR RESPONDING TO THE REREGISTRATION ELIGIBILITY DECISION (RED)**  1. **DATA CALL-IN (DCI) OR "90-DAY RESPONSE"** --If **generic data** are required for reregistration, a DCI letter will be enclosed describing such data. If **product specific data** are required, another DCI letter will be enclosed listing such requirements. If **both generic**  **and product specific data** are required, a combined Generic and Product Specific letter will be enclosed describing such data. Complete the two response forms provided with each DCI letter (or four forms for the combined) by following the instructions provided. **You must submit the response forms for each product and for each DCI within 90 days of the date**  **of this letter (RED issuance date); otherwise, your product may be suspended.** 2. **TIME EXTENSIONS AND DATA WAIVER REQUESTS** --No time extension requests will be granted for the 90-day response. Time extension requests may be submitted only with respect to actual data submissions. Requests for data waivers must be submitted as part of the 90-day response. Requests for time extensions should be submitted in the 90-day response, but certainly no later than the 8-month response date. All data waiver and time extension requests must be accompanied by a full justification. All waivers and time extensions must be granted by EPA in order to go into effect. 3. **APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"**

-- **You must submit the following items for each product within eight months of the date of this letter**  **(RED issuance date).**

a. **Application for Reregistration** (EPA Form 8570-1). Use only an original application form. Mark it "Application for Reregistration." Send your Application for Reregistration (along with the other forms listed in b-e below) to the address listed in item 5. b. **Five copies of draft labeling** which complies with the RED and current regulations and requirements. Only make labeling changes which are required by the RED and current regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation changes, or labeling changes not related to reregistration) separately. You may delete uses which the RED says are ineligible for reregistration. For further labeling guidance, refer to the labeling section of the EPA publication "General Information on Applying for Registration in the U.S., Second Edition, August 1992" (available from the National Technical Information Service, publication #PB92-221811; telephone number 703-487-4650).

c. **Generic or Product Specific Data** . Submit all data in a format which complies with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA identifier (MRID) numbers. Before citing these studies, you must **make sure that they meet the Agency's acceptance criteria**  (attached to the DCI). d. **Two copies of the Confidential Statement of Formula (CSF)** for each basic and each alternate formulation. The labeling and CSF which you submit for each product must comply with P.R. Notice 91-2 by declaring the active ingredient as the **nominal concentration** 

. You have two options for submitting a CSF: (1) accept the standard certifiedlimits (see 40 CFR §158.175) or (2) provide certified limits that are supported by the analysis

of five batches. If you choose the second option, you must submit or cite the data for the five batches along with a certification statement as described in 40 CFR §158.175(e). A copy of the CSF is enclosed; follow the instructions on its back.

e. **Certification With Respect to Data Compensation Requirements**. Complete and sign EPA form 8570-31 for each product. 4. **COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE** --Comments pertaining to the content of the RED may be submitted to the address shown in the Federal Register Notice which announces the availability of this RED. 5. **WHERE TO SEND PRODUCT SPECIFIC DCI RESPONSES (90-DAY) AND APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)**  **By U.S. Mail:** Document Processing Desk **(RED-SRRD-PRB)** Office of Pesticide Programs (7504C) EPA, 401 M St. S.W. Washington, D.C. 20460-0001 **By express:** Document Processing Desk **(RED-SRRD-PRB)** Office of Pesticide Programs (7504C) Room 266A, Crystal Mall 2 1921 Jefferson Davis Hwy. Arlington, VA 22202 6. **EPA'S REVIEWS** --EPA will screen all submissions for completeness; those which are not complete will be returned with a request for corrections. EPA will try to respond to data waiver and time extension requests within 60 days. EPA will also try to respond to all 8- month submissions with a final reregistration determination within 14 months after the RED has been issued.**ENVIRONMENTAL PROTECTION AGENCY OFFICE OF PESTICIDE PROGRAMS**  **SPECIAL REVIEW AND REREGISTRATION DIVISION** 

### REREGISTRATION ELIGIBILITY DECISION **SODIUM FLUOROACETATE**

**LIST C CASE 3073** 

### TABLE OF CONTENTS

**SODIUM FLUOROACETATE REREGISTRATION ELIGIBILITY DECISION TEAM**

...................................................... i **EXECUTIVE SUMMARY**

........................................ iv **I. INTRODUCTION** 

.......................................... 1 **II. CASE OVERVIEW** 

......................................... 2 **A. Chemical Overview** 

.................................... 2 **B. Use Profile** 

.......................................... 2 **C. Estimated Usage of Pesticide** 

.............................. 3 **D. Data Requirements** 

..................................... 4 **E. Regulatory History** 

..................................... 4 **III. SCIENCE ASSESSMENT** 

..................................... 9 **A. Physical Chemistry Assessment** 

............................. 9 **B. Human Health Assessment** 

................................ 9 **1. Toxicology Assessment** 

.............................. 9 **a. Acute Toxicity** 

.............................. 9 **b. Subchronic Toxicity** 

.......................... 10 **c. Metabolism** 

............................... 10 **d. Reference Dose** 

............................. 11 **2. Exposure Assessment** 

.............................. 11 **a. Dietary and Occupational/Residential Exposure** 

....... 11 **3. Risk Characterization** 

............................. 11 **a. Toxicological Endpoints** 

....................... 11 **b. Occupational and Residential** 

................... 11 **C. Environmental Assessment** 

............................... 11 **1. Ecological Toxicity Data** 

........................... 11 **a. Toxicity to Terrestrial Animals** 

.................. 12 **b. Toxicity to Aquatic Animals** 

.................... 14 **c. Toxicity to Plants** 

........................... 16 **2. Environmental Fate** 

.............................. 16 **a. Environmental Fate Assessment** 

.................. 16 **b. Environmental Fate and Transport** 

............... 17 **c. Water Resources** 

............................ 18 **3. Exposure and Risk Characterization** 

................... 18 **a. Ecological Exposure and Risk Characterization** 

....... 18 **IV. RISK MANAGEMENT AND REREGISTRATION DECISION** 

........... 29 **A. Determination of Eligibility** 

.............................. 29**1. Eligibility Decision** 

............................... 30 **2. Eligible and Ineligible Uses** 

......................... 30 **B. Regulatory Position** 

................................... 30 **1. Restricted Use Classification** 

......................... 30 **2. Endangered Species Statement** 

....................... 30 **V. ACTIONS REQUIRED OF REGISTRANTS** 

....................... 31 **A. Manufacturing-Use Products** 

............................. 31 **1. Additional Generic Data Requirements** 

.................. 31 **2. Labeling Requirements for Manufacturing-Use Products** 

...... 31 **B. End-Use Products** 

.................................... 31 **1. Additional Product-Specific Data Requirements** 

............ 31 **2. Labeling Requirements for End-Use Products** 

............. 32 **C. Existing Stocks** 

...................................... 38 **VI. APPENDICES**

........................................... 39 **APPENDIX A.**  **Table of Use Patterns Subject to Reregistration**

....... 40 **APPENDIX B.**  **Table of the Generic Data Requirements and Studies Used t**  **o Make the Reregistration Decision** 

.......................... 47 **APPENDIX C.**  **Citations Considered to be Part of the Data Base Supporting the**  **Reregistration of Sodium Fluoroacetate**

...................... 50 **APPENDIX D.**  **Product Specific Data Call-In**

................... 56 **Attachment 1.**  **Chemical Status Sheets**

................... 67 **Attachment 2.**  **Product Specific Data Call-I n Response Forms (Form A**  **inserts) Plus Instructions**

........................... 68 **Attachment 3.**  **Pr oduct**  **Specific Requirement Status and Registrant' s**  **Response Forms (Form B inserts) and Instructions**

.......... 72 **Attachment 4.**  **EPA Batching of End-Use Products for Meeting Dat**  **a Requirements for Reregistration** 

...................... 75 **Attachment 5.**  **List of All Registrants Sent This Data Call-In (insert**  **) Notice** 

........................................ 77 **Attachment 6.**  **Cost Share, Data Compensation Forms, Confidentia**  **l Statement of Formula Form and Instructions** 

............. 79 **APPENDIX E.**  **List of Available Related Documents**

............... 86i

**SODIUM FLUOROACETATE REREGISTRATION ELIGIBILITY DECISION TEAM Office of Pesticide Programs:**  Biological and Economic Analysis Division Alan Halverson Economic Analysis Branch Gabe Patrick Biological Analysis Branch Environmental Fate and Effects Division David Farrar Science Analysis and Coordination Staff Richard Felthousen Ecological Effects Branch Gail Love Environmental Fate and Groundwater Branch Health Effects Division Charles Frick Chemical Coordination Branch Pat McLaughlin Toxicology Branch Winston Dang Occupational and Residential Exposure Branch Registration Division Bipin Gandhi Registration Support Branch Mark Perry Registration Support Branch Bill Jacobs Insecticide-Rodenticide Branch Dan Peacock Insecticide-Rodenticide Branch Special Review and Reregistration Division Leonard Ryan Accelerated Reregistration Branch Kathleen Depukat Accelerated Reregistration Branch Policy and Special Projects Staff Jean Frane **Office of Compliance:** Mickey Post

## GLOSSARY OF TERMS AND ABBREVIATIONS

ii ADI Acceptable Daily Intake. A now defunct term for reference dose (RfD). AE Acid Equivalent a.i. Active Ingredient ARC Anticipated Residue Contribution CAS Chemical Abstracts Service CI Cation CNS Central Nervous System CSF Confidential Statement of Formula DFR Dislodgeable Foliar Residue DRES Dietary Risk Evaluation System DWEL Drinking Water Equivalent Le vel (DWEL) The DWEL represents a medium specific (i.e. drinking wat er) lifetime exposure at which adverse, non carcinogenic health effects are not anticipated t o occur. EEC Estimated Enviro nmental Concentration. The estimated pesticide concentration in an environment, such as a terrestrial ecosystem. EP End-Use Product EPA U.S. Environmental Protection Agency FDA Food and Drug Administration FIFRA Federal Insecticide, Fungicide, and Rodenticide Act FFDCA Federal Food, Drug, and Cosmetic Act FOB Functional Observation Battery GLC Gas Liquid Chromatography GM Geometric Mean GRAS Generally Recognized as Safe as Designated by FDA HA Health

Adv isory (HA) The HA values are used as informal guidance to municipalities and othe r organizations when emergency spills or contamination situations occur. HDT Highest Dose Tested LC Me

dian Lethal Concentration. A statistically derived concentration of a substance that can b e 50 expected

to cause death in 50% of test animals. It is usually expressed as the weight of substance per weight or volume of water, air or feed, e.g., mg/l, mg/kg or ppm. LD Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50% 50 of

the test animals when administered by the route indicated (oral, dermal, inhalation). It i s expressed as a weight of substance per unit weight of animal, e.g., mg/kg. LD Lethal Dose-low. Lowest Dose at which lethality occurs lo LEL Lowest Effect Level LOC Level of Concern LOD Limit of Detection LOEL Lowest Observed Effect Level MATC Maximum Acceptable Toxicant Concentration MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulat e contaminants in drinking water under the Safe Drinking Water Act. μg/g Micrograms Per Gram mg/L Milligrams Per Liter MOE Margin of Exposure MP Manufacturing-Use Product MPI Maximum Permissible Intake MRID Master Record Identificati on (number). EPA's system of recording and tracking studies submitted. N/A Not Applicable NOEC No effect concentration NPDES National Pollutant Discharge Elimination System

## GLOSSARY OF TERMS AND ABBREVIATIONS

iii NOEL No Observed Effect Level NOAEL No Observed Adverse Effect Level OP Organophosphate OPP Office of Pesticide Programs PADI Provisional Acceptable Daily Intake PAG Pesticide Assessment Guideline PAM Pesticide Analytical Method PHED Pesticide Handler's Exposure Data ppb Parts Per Billion PPE Personal Protective Equipment ppm Parts Per Million PRN Pesticide Registration Notice Q The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model * 1 RBC Red Blood Cell RED Reregistration Eligibility Decision REI Restricted Entry Interval RfD Reference Dose RS Registration Standard SLN Special Local Need (Registrations Under Section 24 (c) of FIFRA) TC Toxic Concentration. The concentration at which a substance produces a toxic effect. TD Toxic Dose. The dose at which a substance produces a toxic effect. TEP Typical End-Use Product TGAI Technical Grade Active Ingredient TLC Thin Layer Chromatography TMRC Theoretical Maximum Residue Contribution torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions. FAO/WHO Food and Agriculture Organization/World Health Organization WP Wettable Powder WPS Worker Protection Standardiv

**EXECUTIVE SUMMARY** The Environmental Protection Agency has completed an assessment of the potential human health and environmental risks associated with the pesticidal use of sodium fluoroacetate in the United States. Based on its review of the targe database, the Agency has determined that th e currently registered uses will not cause unreasonable risk to humans or the environment and that these uses are therefore is eligible for reregistration. Sodium fluoroacetate (Compound 1080) is an acute toxicant predacide against coyote s which prey on sheep and goats. Currently registered en d-use products are 1% solutions which are injected into the rubber reservoirs of Livestock Protection Collars. These collars are strapped to the throats of sheep or goats. Coyotes attempting to kill collared livestock are likely to puncture the collars and to be fatally poisoned by sodium fluoroacetate as a result. S o dium fluoroacetate is highly toxic to warm blooded animals, including humans, when taken internally. Additionally, sodium fluoroacetate may pose a high acute risk to non-targe t birds and mammals that may scavenge the carcasses of predators that are killed from biting the co llared livestock. State-limited registrations for sodium fluoroacetate collars have been issued in T exas, New Mexico, Wyoming, Montana, and South Dakota. The use of these products are further limi ted to only those states which have an EPA-approved certification and trainin g program, which

currently includes only Texas, New Mexico, Wyoming, and Montana. The use is further restricted within these four states to specific counties when there is potential for adverse effects to endangered species. Before reregistering the products containing sodium fluo roacetate, the Agency is requiring that product specific data, revised Confidential S tatements of Formula (CSF) and revised labeling be submitted within eight months of the issuance of this document. These data include product chemistr y for each registration. After reviewing these data and any revised labels and findin g them acc eptable in accordance with Section 3(c)(5) of FIFRA, the Agency will reregister a product.1

**I. INTRODUCTION**  In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended to accel erate the reregistration of products with active ingredients registered prior to November 1, 1984. The a

mended Act provides a schedule for the reregistration process to be completed in nine years. There are five phases to the reregistration process. The first four phases of the process focus on identification of data requirements to support the reregistration of an active ingredient and the generation and sub mission of data to fulfill the requirements. The fifth phase is a review by the U.S. Environmental Protection Agency (re ferred to as "the Agency") of all data submitted to support reregistration. FIFRA Se

ction 4(g)(2)(A) states that in Phase 5 "the Administrator shall determin e whether pesticides containing such a ctive ingredient are eligible for reregistration" before calling in d ata on products and either reregistering products or taking "other appropriate regulator y action." Thus, reregistration involves a thorough review of the scientific data base underlying a p e sticide's registration. The purpose of the Agency's review is to reassess the potential hazards ar ising from the currently registered uses of the pesticide; to determine the need for additiona l data on health and environmental effects; and to determine whether the pesticide meets the "no unreasonable adverse effects" criterion of FIFRA. Thi s document presents the Agency's decision regarding the reregistration eligibility o f the registered uses of sodium fluoroacetate. The document con sists of six sections. Section I is the introduction. Section II describes sodium fluoroacetate , its uses, data requirements and regulatory history. Section III discusses the human health and environmental assessment based on the data available to the Agency. Section IV p resents the reregistration decision for sodium fluoroacetate. Section V discuss

es the reregistration requirements for sodium fluoroacetate Finally, Section VI is t he Appendices which support this Reregistration Eligibility Decision. Additional detail s concerning the Agency's review of applicable data are available on request.2

**II. CASE OVERVIEW**  **A. Chemical Overview**  Th e following active ingredient is covered by this Reregistration Eligibilit y Decision: **Common Name:** Sodium Fluoroacetate

**Chemical Name:** Sodium Monofluoroacetate **Chemical Family:** Fluoroacetic Acid **CAS Registry Number:** 62-74-8

**OPP Chemical Code:** 075003 **Empirical Formula:** F-CH -C-O -Na 2 2
**Trade and Other Names:** Compound 1080

**Basic Manufacturer:** U. S. Department of Agriculture-registrant Tull Chemical Company, Oxford. AL.-m anufacturer **B. Use Profile**  Presented be

low is information on the currently registered uses with an overview of use sites and application methods. A detailed table of the registered uses of sodiu m fluoroacetate is in Appendix A. For **Sodium Fluoroacetate** : **Type of Pesticide:** Predacide **Mode of action** : Stomach poison.3 **Use Sites:** Sheep, lambs, kids, goats, dairy goats (lactating or unspecified), goats (wool/angora animal)
**Target Pests:** Product kills coyotes preying on sheep or goats. **Formulation Types** Formulation Intermediate - 90% a.i. **Registered:** Collar: 1% a.i. availab le. All Collars contain 1.1 oz of formulated material which is equal t o approximately .00067 lbs a.i./collar. **Method and Rates of Application:**  When predation is anticipated, collars ( one collar per col lared animal) are strapped in place with th e rubb er toxicant reservoirs positioned in the throa t regio ns of sheep or goats in target flocks or herds

. Th e sodium fluoroacetate solution is released if a col lar reservoir is punctured by an attacking coyote or by another agent. Up to 20 collars may be used in fenced pastures up to 100 acres in size. Up to 50 collars may be used in past ures of 101 to 640 acres. Up to 100 collar s may be used in pastures of 641 to 10,000 acres.

**Use Practice Limitations:**  For a complete listing of product limitations, se e Sect ion V, Labeling Requirements for End-us e Products.

**C. Estimated Usage of Pesticide**  This section summarizes the best estimates available for the pesticide uses o f sodium fluoroacetate. These estimates are derived from a variety of published an d proprietary sources availa ble to the Agency. The data, reported on an aggregate and site basis, reflect annual fluctuations in use patterns as well as the variability in using dat a from various information sources. Table 1, below, summarizes the amounts of sodium fluoroacetate used by site.4

**Table 1. Estimates of Typical Usage of Sodium Fluoroacetate** Site Head Available Head Treated Site Treated Lbs a.i.

(000) (000) (%) applied Sheep - US 9080- 10850 0.6 - 0.7 <0.01 <1 MT only 520 - 580

- - - NM only 460 - 510

- - - SD only 540 - 590

- - - TX only 1710 - 1940

- - - WY only 830 - 850

- - - Goats - US 2250 - 2550 0.2 <0.01 <0.5 NM only 80-90

- - - TX only 1650 - 1960

- - - Total - US 11330 - 13400 0.8 - 0.9 <0.01 <1 1987 Census of Agriculture: US New Mexico Agricultural Statistics, 1988 Pesticide Use in Wyoming, 1990 South Dakota Agriculture on the Move, 1993-1994 Wyoming Agricultural Statistics, 1992 Texas Ag. Facts, Annual Summary, 2/25/94Montan a Agricultural Statistics, 1987 USDA/APHIS Animal Damage Control EPA information, reports and proprietary sources Notes: Coyote is the only active pest. Goats and sheep are the only active sites. Method of application is by collar. **D. Data Requirements**  The da ta required to support the uses of sodium fluoroacetate are identified i n Appe ndix B. This includes all data requirements identified by the Agency to suppor t reregistration for currently registered use. **E. Regulatory History**  Origins and Early Development This chemical case pertains to a large "family" of chem icals which are metabolized in the manner of fluoroacetic acid and which, consequently, are very toxic (Pattison , 1959). Of these chemicals, sodium monofluoroacetate (Compound 1080) an d fl uoroacetamide

(Compound 1081) have been registered as pesticides in the U.S. Fo r reasons outlined belo

w, there no longer are any registered uses of fluoroacetamide in the U.S. Legal use of sodium monofluoroacetate is limited to livestock protection colla r products. Poisons in the fluoroacetic acid "family" occur natura lly in Western Australian and South African plants that have been implica ted in the poisoning of livestock (Aplin, 1979; Patti son, 1959). The gifblaar plant ( Dichapetalum cymosum ) of South Africa arises a s5

small tufts of leaves and flow ers from long and extensively branched underground stems. Af ricans have used extracts of gifblaar (which means "toxic leaf") and related plants a s arrow poisons. Th e active substance in gifblaar was extracted as its potassium salt, potassiu m fluoroacetat

e, in 1943 or 1944 (Marais, 1944 cited by Pattison, 1959). By that time , resea rch already had been undertaken on synthesized fluoroacetic acid and relate d compounds. Synthesis of fluoroacetic acid was reported in 1896 by the Belgian researche r Swarts (cited by Pattison, 1959). Fluoroacetic acid was patented in Germany in 1930 as a mothproofing agent. Subsequently, Germans researched a num ber of related compounds as potential chem

ical warfare agents and systemic insecticides. In the mid-to-late 1930s, Pol ish military researchers discovered that fluoroacetate compounds are extremely toxic materials. Much of the research conduc ted in Nazi-occupied countries prior to the end of World War II was either lost or very late in being reported publicly. The escape of a Polish scientist to England brought elements of the knowledge gained in Poland to th e allied side. Further research took place in England and in the U.S. English scientist s ul timately

concluded that "compounds that form fluoroacetic acid by hydrolysis and/o r oxidation are toxic." (Pattison, 1959, p. 19) In the U.S ., research on compounds related to fluoroacetic acid led to severa l deve lopments, including the development of sodium fluoroacetate as a rodenticide an d mammalian

predacide and fluoroacetamide as a rodenticide. The names 1080 and 1081 for so dium fluoroacetate and fluoroacetamide, respectively, came from the invoic e numb ers that these materials were assigned in U.S. Government laboratories (Peacock , 1964). Extensive research on this family of ch emicals after World War II led to a general understanding of the mode of toxic action and the development of analytical method s which, if not extremely sensitiv e by present standards, were at least able to detect the use of compounds related to fluoroacetic acid in certain homicides (Patt ison, 1959). However, the pr oblem of poor recovery of sodium fluoroacetate in or on animal tissues remaine d until the mid 1980s (Kimball and Mishelanie, 1993). U.S. Regulatory History of Sodium Fluoroacetate Development and use of sodium fluoroacetate as a predacide and rodenticide in the U.S

. began in the 1940s (e.g., Robinson, 1948), prior to the 1947 enactment of th e Fede ralInsecticide, Fungicide and Rodenticide Act (1947) by which requirements fo r Fed eral registration of pesticide products were instituted. Products containing sodiu m fluoroacetate were among those registered shortly after the registration requirement went6

into effect. Pattison (1959) rep orts that the Monsanto Corporation produced about 5 tons of sodium fluoroacetate in 1948. In 1955, Monsanto's 90% sodium fluoroacetate product was t ransferred to Tull Chemical Company of Oxford, AL. By the early 1970s, Tul l Chemica lCompany was the only firm legally producing sodium fluoroacetate for pes t control purposes in the U.S. Tul l's registered product at the time, EPA Registration No. 5217-1, was a 90% sodium fluoroacetate concentrate which was labeled for mixing baits that could be applied to control a variety of rodents and predatory mammals. In 1964 and again in 1971, the use of poisons to control predatory mammals were rev iewed by select committees (Leopold, et al 1964; Cain, et al , 1972). Following th e issuance o f the "Cain Report", President Nixon issued Executive Order 11643, whic h banned the use of poisons to cont rol predators on Federal lands. Shortly thereafter, EPA issued PR Notice 72-2 which canceled all registered predator control uses of sodiu m fluoroacetate, sodium cyanide, and strychnine (Ruckelshaus, 1972). Subsequent to th e cancellation of predacidal uses of sodium fluoroacetate, sever al parties sought to have such uses restored. There was a period of illegal use of sodium fluoroacetate as a predacide i n Wyomi ng

from 1975 to 1977 (Thomas, 1983, p. 22; see also Nissen, 1982, p. 79; an d Johnson, 1978). In 1977, the U.S. Departm ent of the Interior (USDI) applied for an Experimental Use Permit (EUP) to investigate the potential risks and benefits associated with the use of sodium fluoroac

etate in "toxic collars" which would be placed on the necks of sheep and goat s. Rubber pouches containing sodium fluoroacetate solution would be positione d around the animals' throat regi ons where they would be likely to be ruptured by the teeth of coyotes that attempted to kill the livestock with species-typical throat bites. In 1981, EPA was petitioned by the USDI and livestock interests to re visit the 1972 predacide cancellati on decision with respect to sodium fluoroacetate. EPA responded by holdi ng informal hearings on the issue in 1981 and formal, Subpart D administrative hearings i n 1982. The Subpart D hearings considered reinstatement of sodiu m fl uoroacetate

in injected-carcass bait stations and three additional types of applications : toxic collars, small "single-dose baits" i ntended to provide enough toxicant to reliably kill one coyote, and "smear posts." The initial and final decisions (Nissen, 1982; Thomas , 1983) pe rmitted EPA to consider applications for registration of sodium fluoroacetate in toxic collars and single-dose baits and rejected the carcass baits and smear posts. On July 18, 1985, EPA granted a registration to USDI for a toxic collar product (E PA Registration Number 6704-85). By then, the product was called the "Livestoc k Protection Collar." In 1986, thi s product was transferred to the Animal and Plant Health Inspect ion Service (APHIS) of the U.S. Department of Agriculture (USDA). Its ne w Registration No. became 56228-22. Since 1987, five S tate-limited registrations have been issued for Livestock Protection Collars. These product s permit use of collars in Montana,7

Ne w Mexico, South Dakota, Texas, and Wyoming. However, there is no approve d training and certification program in South Dakota. A concentrate product registered to APHIS (56228-26) that is limited to use in the manufacture of Livestoc k Protection Collars an d the six registered livestock collar products mentioned above are the only registere d pesticide products in the U.S. which legally contain sodium fluoroacetate. In the mid 1980s, USDI and later APHIS obtained EUPs which authorized field trials with sodium fluoroacetate single-dose baits made of tallow. These baits eac h contained 5 mg of active ingredient. However, sod ium fluoroacetate was never registered for this use pattern. The rodenticidal uses of sodium fluoroacetate were not directly affected b y Executive

Or der 11643 or by PR Notice 72-2. However, the U.S. Department of th e Interior withdrew it

s sodium fluoroacetate rodenticide products following the issuance of Exec utive Order 11643. At the time, Tull's 5217-1 product and dozens of intrastat e registrations for rodenticidal uses of sodium fluoroacetate remained valid. In 1978, EPA classified all legal uses of sodium fluoroac etate as "Restricted" due to "Acute oral toxicity hazard to nontarget organisms, use and accident history." (Costle, 1978) In the mid 1970s, EPA placed the non-predacidal uses of sodium fluoroacetate into its RPAR ("Rebuttable Presumption Against Registration") process , the forerunner to what now is called "Special Review." On December 1, 1976, EPA's "Position Document 1" (PD1) was published (41FR52792, 1976). EPA announced a preliminary decision in the RPAR in a second document, the PD 2/3, on November 4, 1983 ( Barbehenn, et al , 1983). Af ter consideration of responses to the PD2/3, EPA issued its final decision in the form of a PD4 document in July of 1985 (Anonymous, 1985). The PD 4 called for retention of all ro denticidal uses of sodium fluoroacetate that were permitted at that time, but also imposed si gnificant requirements to modify labels and to supply missing research data

. The PD4 represented a significant chan ge in EPA's regulatory position from that taken in the PD 2/3 document, which had recommended cancellation or denial of many uses and modification of all others except those for control of commensal rodents "in and around buildings and ships" (Barbehenn, et al , 1983). The data call-in issued with t he PD4 sought information on the chemistry, residue chemistry, environmental fate, toxicology, a nd ecological effects of sodium fluoroacetate. The PD4 also dictated that 0.02 % was the highest active ingredient strength that could be used for prairie dog control, where such use was permitted, and for ground squirre l control with

in the range of the California condor. EPA gave registrants whose products were used in such areas the option of developing efficacy data "to establish the lowes t effective concentration" if the 0.02% level did not appear to be effective (Anonymous, 1985). The Agency reserved the right to modify the decisions reached in the PD4. Tull 's product 5217-1 was canceled "by operation of law on February 18, 1986" (Y ost, 1989) because the company did not respond to a November 22, 1985, "Notice of8

Intent to Cancel" (Campt, 1985) requiring that an application for amended registration was submitte d within 90 days of the letter. Later, other parties indicated that they woul d provide the data that Tull would not commit to obtain. On November 13, 1986, Tull was granted a registration (5217-2) for a 90% s odium fluoroacetate product that could be used only as a source of active ingred ient for registered sodium fluoroacetate products. Along with this registration, EPA issued a schedule for supplying missing data pertaining t o Tull's new product. After two deadlines for submitting data for Tull's new product (5217-2) passed , EPA refrained from taking immediate cancellation action. Instead, EPA met with parties (e.g., end-use registrants, user groups) concerned with the potential loss of a source o f sodium fluoroace

tate for controlling rodents. After the various meetings had concluded, EPA issued r

evised data call-ins in December 1987 pertaining to 5217-2 and to th e rod enticidal uses of sodium fluoroacetate (Tinsworth, 1987a,b). Due to lack o f appropriate responses toward supplying the data required by the 1985 and 1987 data callins (Campt, 1988), EPA proceeded toward canceling Tull's ma nufacturing use concentrate (5217-2). The product was canceled on February 21, 1989 (Yost, 1989). Subsequently, all "special local needs" registrations issued under §24(c) of FIFRA were canceled, and all pend ing applications for Federal registration of intrastate products containing sodium fluoroacetate

were denied. These actions were completed by August 9, 1990 (Campt , 1990). Regulatory Status of Sodium Fluoroacetate The currently registered uses of sodium fluoroacetate are strictly limited t o livestock protection collars as a predacide in those states whic h have registrations and EPA approved certification and training programs. Since all other predacid al uses were canceled by the Admi nistrator in 1972, as described above in the regulatory history, additiona l predacidal uses cannot be granted without o bservation of the procedures for reconsidering cancellation decisions set forth in 40 CFR Part 164, Subpart D. Under the provisions of Subpart D, an application for a new predicidal use o f sodium fluoroacetate would require the submission by an applicant of substantial ne w evidence w hich might have affected the cancellation decision and could not have bee n made av ailable to the Administrator during the prior proceeding. In addition, Subpart D requires that the Administrator conduct a hearing before granting reconsideration of the 1972 cancellation decision. U.S. Regulatory History of Fluoroacetamide Fluoroaceta

mide (Compound 1081) was first registered as a pesticide in the U.S. in 197 2. In 1976, EPA began an RPAR for this compound because of potential hazards to humans and nontarget animal s. In 1978, all uses of fluoroacetamide were classified as "Restri cted" because of "acute oral toxicity" (Costle, 1978) and the absence of a tru e9

antidote. In 1979, label changes were adopted to address the Agency's most critica l concerns by limiting use of the sole registered product to sewers. As a result, the RPAR process with respect to this chemical was concluded (PD2, Feb. 28, 1980 - 45FR 13189). Fluoroac etamide ultimately was canceled in 1989 after the registrant of the only product failed to pay the registration maintenance fee. **III. SCIENCE ASSESSMENT**  **A. Physical Chemistry Assessment**  Sodium fluoroacetate is a sodium salt of fluoroacetic acid which is a tan colored alk aline powder with a pH of 10.3. This is probably due to the sodium hydroxid e impurity. It melts at 197

-203 C with decomposition. It is soluble in water but practically insoluble in all non-polar solvents. Sodium fluoroacetate is stable in sunlight, at a temperature of 54 C, and in tin coated metal containers. **B. Human Health Assessment**  **1. Toxicology Assessment**  The toxic ological data base on sodium fluoroacetate is adequate and wil l support reregistration eligibility.

**a. Acute Toxicity**  **Table 2. Acute Mammalian Toxicity**

TEST RESULTS CATEGORY Oral LD50--rat LD 0.22 mg/kg I 50 Dermal LD50--rabbit LD 277.1 mg/kg M; II 50 324.2 mg/kg F Eye irritation--rabbit slight irritation III Dermal irritation--rabbit not irritating IV

An acute oral toxicity study with rats used 90.0% sodiu m fluoro acetate. The LD was 0.22 mg/kg, which is toxicity category I 50 (MRID 40016971). An acute oral toxicity study with coyotes used doses of sodium fluoroacetate diluted with water. The LD was 0.12 mg/k g 50 sodium fluoroacetate, which is toxicity category I (MRID 00065627)

. Literature

reports have indicated oral LD s of 0.10 mg/kg for rats, 0.50 50 mg/kg for m

ice, 0.066 mg/kg for dogs, and 0.34 mg/kg for rabbits. The human oral LD has been reported as 0.714 mg/kg, and the potentiall y

lo toxic dose for humans has been stated as 0.5-2.0 mg/kg (Sax and Lewis, 1989).10 An acute dermal toxicity study with rabbits used technical sodium fluoroacetate. The L D was 277.1 mg/kg for males and 324.2 mg/kg for 50 females. The animals showed lethargy, diarrhea, and convulsion s precedi ng

death, along with extensive hemorrhage of the thymus an d congestion of the lungs. This is toxicity category II (MRID 152129). A pr imary eye irritation study used a 1.0% aqueous solution o f sodiu m fluoroacetate with rabbits. There was slight irritation and sligh t che mosis, which is toxicity category III (MRID 40402603). A primar y dermal i rritation study also used a 1.0% aqueous solution on rabbits

. There was only transient slight edema on on e rabbit and the compound was considered not irritating (MRID 40402604). Requirements fo

r acute inhalation toxicity and dermal sensitization studie s were waived due to the severe acute toxicity of the compound and the restriction of its use in a livestock protection collar. **b. Subchronic Toxicity**  Technical sodium fluoroacetate was administered by gavage for 13 weeks to Crl:CD(SD)Br rats. The doses were 0, 0.05, 0.20, or 0.5 0 mg/kg/da

y. The NOEL was 0.05 mg/kg/day. The LOEL was 0.2 0 mg/kg/day, based on dose-related findings in histopatholog y (h ypospermatogenesis, fusion bodies, and immature or abnormal sperm ) and decreased size and weight of testes and epididymides in males

. Females had dose-related increases in absolute and relative heart weight s at the mid and high doses (Wolfe, 1988). In a study with male Sprague Dawley rats, the animals were dosed with 0, 0.07, 0.19, or 0.71 mg/kg/day of sodium fluoroacetate in thei r drinking wat

er for seven days. This was followed by 21 days without the test compou

nd. A group of rats from each dose level was killed each day of treatment and on days 3, 7, 14, and 21 after d osing. The testes, kidneys and liver were examined. Testicular atrophy and nonreversible tubula r degeneration were found at the mid and high dos e. Testicular atrophy with reve rsible tubular degeneration was found at the low dose. No effects on liv er or kidney were seen. The lowest dose was the LOEL (MRI D 40016990).

**c. Metabolism**  Fluoroacetate in the m

ammalian body is converted to fluorocitrate. This compound inhibits the enzyme aconitase, thus blocking the citric acid cycle

. This leads to accumulation of citric acid, which may caus e11 con vulsions and death from cardiac failure or respiratory arrest (Gribble, 1973). Sodium

fluoroacetate can be absorbed through the gastrointestinal tract, respiratory tract, or open wounds, but only slow ly through intact skin (Sax and Lewis, 1989). **d. Reference Dose**  The RfD was determined to be 0.00002 mg/kg/day. This w as based on t he 13-week subchronic oral rat study, in which the NOEL was 0.0 5 mg/kg /day. An uncertainty factor of 3000 was used to account fo r interspecies extrapolation, intraspecies differences, and lack of additional studies (Ghali, 1994). **2. Exposure Assessment** 

**a. Dietary and Occupational/Residential Exposure**  Under the current permitted use pattern there will be no sodiu m fluoroacetate

exposure to the general population. Based on the us e information, there are no applicator/mixer/loader or post-applicatio n exposure concerns other than following the label restriction for use b y certified personnel only. **3. Risk Characterization** 

**a. Toxicological Endpoints**  Because o f the specific nature of this registered use, the primar y concern is for the potential risk of acute toxicity. **b. Occupational and Residential**  The re are no uses of sodium fluoroacetate in residentia l envi ronments. Based on the use information, potential risk for acut e toxicity to workers exposed to sodium fluoroacetate is not expected. **C. Environmental Assessment**  **1. Ecological Toxicity Data**  The Agency has adequate data to assess the hazard of sodium fluoroacetate to nontarget organisms.12 **a. Toxicity to Terrestrial Animals**  In order to establish the acute and subacute toxicity of sodiu m fluoroacetate to birds, the follow ing tests were required using the technical grade materia

l: one avian single-dose oral LD study on one species; the 50 bobwhite quail ( Colinus virginianus ) or preferably the mallard duck ( Anas platy rhyncos ); two subacute dietary LC studies on one species o f 50 water fowl(preferably the mallard duck) and one species of upland gam e bird (preferably the bobwhite quail or the ring-necked pheasant ( Phasianus colchicus ). **(1) Birds, Acute and Subacute**  Acute oral toxicity The acute oral LD valu

e for the technical grade of sodium 50 fluoroacetate

for avian species has been reported in the literature. Hudson e t al. (1984) reported the acute oral LD values for th e 50 ring-necked pheasant, mallard duck and chukar ( Alectoris graeca ) to be 6.4 (95% C.I. = 3.85-10. 8), 9.1 (95% C.I. = 5.6-14.6) and 3.51 (95% C.I. = 2.58-4.78) mg/kg, respectively. Ward an d Spen cer (1947) determined the acute lethal doses for numerou s avian species and reported LD values as low as 3.0, 5.0, and 15 50 mg/kg for the widgeon ( Mareca americana ), golden eagle (Aquila chrysaetos

), and black vulture ( Cartharista urubu ), respectively

. At zert (1971) reported the LD for the black-billed magpie ( Pic a 50 pica ) to be 1 mg/kg. In addition, the USDA conducted a series of acute oral LD tests on the magpie to get toxicity data for a species

50 that is likely to scavenge the carcasses of coyotes and/or livestock (B urns and Connolly, 1992). Results of these studies showed that the acute o

ral LD for the magpie ranged from 1.78 mg/kg to 2.3

50 mg/kg, depending on temperature and season. These data indicat

e that sodium fluoroacetate is very highly toxic to avian species on an acute oral basis. The guidelin e re quirements for this test have been satisfied. Table 3, below is a data summary for the acute toxicity of sodium fluo roacetate to avian species.13

**Table 3.** AVIAN ACUTE ORAL TOXICITY DATA Species LD mg/kg Conclusions 50 Mallard duck 9.1 highly toxic Chukar 3.5 highly toxic Ring-necked Pheasant 6.4 highly toxic Widgeon 3.0 highly toxic Golden eagle 5.0 highly toxic Black vulture 15.0 highly toxic Black-billed Magpie 1.0 - 2.3 highly toxic

Subacute dietary toxicity Campb ell et al. (1994) reported that the avian dietary LC 50 values of sodium fluoroacetate for the mallard duck and bobwhite quail were 231 (95% C.I.=150-338) and 4 86 (95% C.I.=339-696) ppm, respectively (MRID #s 43210602; 43210601). B ased on these data, sodium fluoroacetate can be classified as highly toxic to avian species on a dietary basis

. The guideline requirements for a dietary study h ave been satisfied. Table 4 is a data summary for th e dietary toxicity of sodium fluoroacetate to avian species. **Table 4.** AVIAN SUBACUTE DIETARY TOXICITY DATA Species LC ppm Conclusion 50 Bobwhite quail 486 highly toxic Mallard duck 231 highly toxic

**(2) Birds, Chronic**  Subst antial chronic exposure to birds is not expected wit h use of the sodium fluoroacetate livestock protection collar. **(3) Mammals**  Wild mammal testing may be required for a pesticid e depending on the

results of the lower tier studies such as acute and suba cute testing and on the intended use pattern and pertinen t environmental fate characteristics. Because the livestock protection14 collar is specificall

y designed to kill a wild mammal (coyote), wild mammal toxicity testing has been required for sodi um fluoroacetate. Ward and Spence

r (1947) determined the acute lethal doses of so dium fluoroacetate for numerous mammalian species an d rep orted LD values as low as 0.1 mg/kg for both the cotton ra t 50 (Sigmodon hispidus

) and coyote ( Canis latrans ). T hey also reported that the LD for the deer mouse ( Peromyces sp .) was 4.0 mg/kg. 50 Beasom (1982) reported that the LD values for the opossu m 50 ( Didelphis virginiana

) and raccoon ( Procyon lotor ) were 41.6 and 1.1 mg/kg, respectively. Atzert (1971) reported that the LD of 50s sodium fluoroac

etate to the striped skunk ( Mephitus mephitus ) and opossum are 1 and 60 mg/kg, respectively. The se data indicate that sod ium fluoroacetate can be classified as very highly toxic t o mammals on an acute oral basis. The gui deline requirement for the wild mammal toxicity test has been satisfi ed. Table 5 is a summary for the acute toxicity of sodium fluoroacetate to mammals. **Table 5.** MAMMALIAN ACUTE TOXICITY DATA Species LD mg/kg Conclusions 50 Coyote 0.1 highly toxic Cotton rat 0.1 highly toxic Deer mouse 4.0 highly toxic Raccoon 1.1 highly toxic Opossum 41.6 highly toxic Skunk 1.0 highly toxic

**(4) Insects**  Data are not required on toxicity to insects, on the basis of negligible exposure associated with the sodium fluoroacetat e livestock protection collar. **b. Toxicity to Aquatic Animals**  **(1) Freshwater Fish**  In order to establish th

e toxicity of a pesticide to freshwater fish, the minimum data required on the tech nical grade of the active in gredient are two freshwater fish toxicity studies. One stud y15 shoul d use a coldwater species (preferably the rainbow trout), and the ot her should use a warmwater species (preferably the bluegil l sunfish). Collins (1993) reported that the 96-hour LC values o f 50 tech nical grade sodium fluoroacetate to the rainbow trou t ( Oncorhynchus mykiss

) and bluegill sun

fish ( Lepomis macrochirus ) were 54 mg a.i./l and > 970 mg a.i./l, respectively. When n o substantial m

ortality occurs at the highest dose evaluated, the LC 50 is rep orted as greater than that dose. Based on these data, sodium fluoroacetate

can be classified as slightly toxic to coldwater fis h sp ecies and practically non-toxic to warm water fish species. The g u ideline requirements for freshwater fish toxicity tests have been satisfied (MRID# 42961601, 42961602 ). Table 6 is a summary for the toxicity of sodium fluoroacetate to freshwater fish. **Table 6.** FRESHWATER FISH ACUTE TOXICITY DATA Species 96-hour LC (mg a.i./l) Conclusions 50 Rainbow trout 54 slightly toxic Bluegill sunfish 970 practically non-toxic **(2) Freshwater Invertebrates**  The m inimum testing required to assess the toxicity of a pesti cide to freshwater invertebrates is a freshwater aquati c invertebrate

toxicity test, preferably using the first instar Daphnia magna or early instar amphipods, stoneflies, mayflies, or midge s ( Chironomus sp

.). Col lins (1993) conducted an acute static toxicity test o n daphnids and determined that the 48-hour EC of sodiu m 50 flu oroacetate

was 350 mg a.i./l (MRID# 42961603). Based o n these data, sodium fluoroacetate can be classified as practically nontoxic to freshwater invertebrates. The guideline r equirement for the freshwater

toxicity test has been satisfied. Table 7 is a summar y for the toxicity of sodium flu oroacetate to freshwater invertebrates. **Table 7.** FRESHWATER INVERTEBRATE TOXICITY DATA Species 48-hour EC50 (mg a.i./l) Conclusions Daphnia magna 350 practically non-toxic16 **(3) Estuarine and Marine Animals**  A c ute toxicity testing with estuarine and marine organisms is required when an end-use product is intended for direc t application to the marine or estuarin e environment or is expected to reach that environment in significant concentra tions. The terrestrial non-food use of sodium fluoroacetate will not result in substantial ex posure to the estuarine environment. Therefore, these data ar e not required.

**c. Toxicity to Plants**  Toxicity data are not required for terrestrial, semiaqua tic, or aquatic plants for sodium fluoroacetate because the chemical is not a herbicide, is not applied aerially, and there is no other a pparent basis for a phytotoxicity concern. **2. Environmental Fate**  The A gency has reviewed all literature submitted on environmental fat e properties, including studies not required for the livestock protection collar use

. No acceptable guideline studies for hydrolysis or other fate properties have been submitted. Four published articles on environmental fate were submitted by the Te xas Department of Agriculture in support of an emergency exemption, and 13 publi shed or unpublished articles were submitted in 1986 by the State o f Cali fornia. These articles were found to be lacking significant data and o f uncertain value, and therefore not, acceptable as guideline st udies. If any new uses of sodium fluoroacetate are proposed, acceptable environmental fate studies may be required.

**a. Environmental Fate Assessment**  The fate properties of the chemical are characterized to the extent possible, recognizing the limitations of the available data. The conclusions are very t entative relative to an evaluation that could be made if guideline studies were available. The limited data available sug gest that leaching and metabolism are the maj or routes of dissipation. However, undegraded fluoroacetate i s considered mobile and consequently has a high potential t o move downward in the soil and reach ground water.17 Sodium fluoroacetate appears to degrade primarily by biologically mediated processes. Sodium fluoroacetate ap pears first to ionize to sodium and fluoroacetate with the fluoroacetate portion further degrading b y biologically mediated processes. Microorganisms capable o f deh alogenating

compounds are reported to metabolize fluoroacetate t o fluoride an

d glycolate faster than other microorganisms. Unvalidated data suggest that sodium fluoroaceta te does not degrade substantially in 27 days in sterile soil. Because there ar

e no leaching adsorption-desorption data, mobility can only be assessed on the basis of solubility in water. Based on solubility in wat er, undegraded fluoroacetate may tend to leach. However, th e potential for leaching may be reduced in some soils by adsorption t o organic matter and clay particles and absorption by plants. **b. Environmental Fate and Transport**  **(1) Degradation**  Hydrolysis (161-1) Three published articles have been submitted to the Agency to sup port the hydrolysis data requirement. These articles wer e found t o be lacking significant data and of uncertain value, an d ther efore, not acceptable to fulfill the hydrolysis guidelin e requirem ent. However, the Agency is not requiring a ne w hyd rolysis study because of the limited amount of sodiu m fluoroa cetate that is used annually in the livestock protectio n co llars, as noted Section II.C. (MRID 00061751, 40016958 , 40016959) Bas ed on one of these published articles the stability o f sodium monofluoroacetate in water and saline was determined for a period of approximately 6 months. An i mmediate loss of fluorine was detected in

both the water and saline solutions. A progressive loss of fluorine was reported in the water solutions. However, the saline solutions indicated no significant decreas es in fluorine content after the initial loss. The chemical reaction was not furthe r addressed in the first of the articles by Goldman (MRID 00061751). However, other articles indicate the following reaction:

XCH COO- + OH = HOCH COO- + X- 2 2 (where X = F, Cl, or I)18 **c. Water Resources**  **(1) Ground Water**  For terrestrial uses, the published or unpublished dat a indicate that small quantities of sodium fluoroacetate have th e potential to reach groundwater. The Agency's P esticides in Ground Water Data

base reports no detections for the period 1971 to 1991. **3. Exposure and Risk Characterization** 

**a. Ecological Exposure and Risk Characterization**  **(1) Exposure and Risk to Nontarget Terrestrial Animals**  Certa in nontarget species of birds and mammals includin g enda ngered and non-endangered species may be exposed by th e following mechanisms: Primary hazard Cont aminated sheep or goat carcasses with either broke n (punctured) or unbroken collars. Toxicant spilled on the ground or vegetation when a collar is punctured. Secondary hazard Carca sses of coyotes killed by the sodium fluoroacetat e livestock protection collars and not removed. Vo mitus of poisoned coyotes. (The chemical has emeti c properties) Based on a variety of studies that ha ve been reviewed by the Ag ency, the principal source of risk is exposure of scavenger s feedin g on the head and neck area of dead livestock bearing th e sodium fluoroacetate livestock protection collars. The other sources of exposure identified abov e are not likely to result in unacceptable risk. Factors that reduce the r isk associated with use of the sodium fluoroacetate

livestock protection collars include rapi d decomp osition of carcasses, selective feeding of scavengers fro m19 wounds on the carca

ss rather than contaminated skin surface of the head or neck, and the emetic property of the chemical. Th e concern s for risk to wildlife can be addressed with applicator s following environmental hazard stat ements, special use restrictions, and endangered species protection statemen ts that are required to be placed on the label. The following is a review of information that applies to the risks to both birds and mammals, which may be exposed by similar mechanisms. Ri sk from exposure to livestock carcasses bearing livestoc k protection collars. The information available suggests that the greatest risk to nontarget species is from exposure to the neck areas of livestoc k carcasses bearing the sodium fluoroacetate livestock protectio n collars. Kno

wlton and Ebbert (1991) used radiolabeled sodiu m fluoroacetate as a p

hysiological marker to determine the amount of toxicant likely to be consumed by a coyote and the amount likely to occur on the necks of collared goats ( Capra sp.) when the coyotes attacked the goats and puncture d the collars that contained 30 ml of the toxi cant. The volume of fluid dispensed from the collar wa s 19. 2 ml on average (range 11.9 to 27.8 ml); the average volum e ingested by the coyote was 1.0 ml (0.1 to 2.9 ml). The averag e amount of toxicant contaminating the neck of the goat was 75 m g (39 to 118 mg). The average amount of t oxicant not recovered was 113 mg (0 to 234 mg). Once punctured, the pouches discharge d over 85% of their contents within a short time period. Relatively little of the toxicant was actually ingested by the coyotes with 6 of 15 coyotes ingesting less than 5 mg when killing the goat. S a varie et al . 1990 also studied contamination of the necks of collared lambs ( Ovi s

sp.) killed by coyotes. They found that 12 conta minated sheepskins contained an average of 96 mg sodiu m fluoroacetate with a range of 23 to 200 mg. Comp arison of the two studies just cited (Knowlton an d Ebbert , 1991; Savarie et al . 1990) suggests that the amount o f toxicant on the necks of collared livestock is similar for goats and sheep. The averag

e amount of sodium fluoroacetate released from the co llar was 130 mg in the goat study (Knowlton and Ebert) and20 135 mg f or the sheep study (Savarie et al .). The amount no t recovered was 5

.6 mg for the goat study and 6.1 mg in the sheep study. In the Knowlton and Ebbert study, the average amount o f fluid con taminating the neck of the goat was 7.5 ml (3.9 to 11. 8 ml ), or about 75 mg toxicant. That level clearly exceeds toxicit y valu es for numerous birds and mammals that could scavenge th e carcass, which suggests that the primary hazard to the scavenger s is quite high. However, field studies reviewed sub sequently suggest th at mortality to scavengers feeding on the carcasses is actuall y minor. For example, it has been observed that vultures, magpies, raven s ( Corvus corax

), red-tailed hawks ( Buteo jamaicensis ) , caracaras (

Polyborus c

heriway ), coyotes, and skunks all scavenged the carc asses of collared livestock killed by coyotes, but non e appeared to have been poisoned (USDA/APHIS, 1991; Connolly, 1980; Littauer, 1983). Several factors may account for the apparent discrepanc y bet ween the field results and the implications of residu e measurement

s. First, the typical behavior of scavengers is to feed at wounds or openings in the carcass or where the skin has bee n torn away from the carcass, rather than on the contaminated neck area. This tendency m

ay greatly reduce the likelihood of exposure to av ian species such as the bald eagle ( Haliaeetus leucocephalus ) (USFWS, 1984, 1985). Connolly (1980) simulated exposure t o non-ta rget animals with a series of tests exposing magpies an d dome stic dogs ( Canis familiaris

) to collared livestock killed b y co yotes. Both dogs and magpies fed heavily on the carcass bu t neither were poisoned. Connolly further observed that both th e species tended to feed on parts where the coyote had previously fed rathe r than on the neck area where the highest contamination i s likely. They concluded t

hat typical feeding behavior of scavengers confers a degree of protection against accidental poisoning b y livestock collars. Secondly, toxicity data suggest that birds likely to scavenge, particularly raptors, tend to be less sensitive t o sodium fluoroacetate than mammals, especially canids (Haegele et al ., 1984; Ward and Spencer, 1947 and

Atzert, 1971). Also, emesis has been observed as an early symptom of sodium fluoroacetate poisoning (Ward and Spencer, 1947) and may cause certain raptors to d iscontinue feeding be fore lethal amounts are absorbed (Dana, 1971). The emeti c pr operty of sodium fluoroacetate is likely to reduce exposure t o21 rapt ors scavenging on livestock, and probably will also make th e raptors less likely to continue feeding on them. Another factor that can greatly influence the primar y hazard, especially in warm weather, is that livestock carcasses decompose rapidly under field con

ditions, rendering them unpalatable to many avian and mammalian species (Burns et al., 1984 and Connolly , 1980). Risk from lost or spilled toxicant Knowlton and Ebbert (1 991) found that the average volume of fluid not recovered was 11.3 (0-23.4) ml or approximately 113 mg sodium

fluoroacetate, which is nearly 33% of the total amount in the 30 m

l collar. It is believed that most of the fluid no t recovered is

spilled on the ground. The available fate information cons ists largely of studies that were not found to be acceptable

. Nevertheless the available information on fate properties suggest s that sodium fluoroacetate tends to be absorbed rapidly to organi c material and tends to degr ade rapidly in soil. The Agency believes that there is no substa

ntial hazard to non-target organisms from the sodium fluoroacetate that spills on the ground as a result of th e collar being punctured by an attacking coyote. Ri sk from consumption of tissue, stomach contents, or vomitus of coy otes killed by the sodium fluoroacetate livestock protectio n collars Connolly (1980) evaluated sodium fluoroacetate residues in muscle of captive coyotes that received known oral doses. At a known or al dose of 5.0 mg the concentration in muscle wa s determ ined to be 0.10 ppm while the 10 mg dose resulted in a concentration of 0.19 ppm. Based on th is relationship a coyote that ingests a n average of 1 ml fluid (10 mg toxicant) will have muscle tissue residues of 0.19 ppm sodium fluoroacetate. The highes t sodium fluoroacet

ate residue level found in muscle tissue was 0.93 ppm. Residues in coyotes that have killed sheep wearing the 30 ml collar have been determined by Burns et al. (1984). Those authors report average concentrations of 0.15 ppm in muscle, 0.5 ppm i n st omach contents, and 0.35 ppm in vomitus. The highest residu e found occurred in the stomach contents and was 2.3 ppm.22 Knowlton and Ebbert (1991) analyzed muscle tissue from 10 coyotes that were kille

d as a result of puncturing collars. Residues were detected in the muscle of all the coyotes. The concentration in muscle tissue was 0.089 ppm (range of 0.05 to 0.280 ppm); the mean±SE sodium fluoroacetate lost from 12 collar s was 92±56 mg (range 3 to 183 mg). Table 9 below gives estimates of the amount of muscl e ti ssue, stomach contents, or vomitus, from coyotes killed with the 30 ml sodium fluoroacetate livestock protection collar that woul d have to be consumed in order for a scavenger to ingest an LD 50 (Burns et al., 1984). These data suggest that secondary hazard to to anim als that may feed on a contaminated coyote carcass i s ordinarily not substantial (Burns et al., 1984; Connolly, 1980 ; Knowlton

and Ebbert, 1991). However, it is likely that carcasse s will oc casionally contain enough sodium fluoroacetate to kill a scavenger. The results below represent averag e exposures. The data suggest substantial variation from one carcass to the next. Thi s qual ification

has to be considered when interpreting statements i n the f ollowing assessments related to muscle tissue, vomitus, an d stomach contents. Table 9. Approximate amounts of tissue from coyotes killed with the 30 ml sodium fluoroacetate livestock protection collars that scavengers would have to consume to obtain an LD of sodium fluoroacetate. 50 Species Average LD LD dose Muscle 0.15 Stomach 0.5 Vomit 0.35

weight (kg) mg/kg (mg) ppm (kg) ppm (kg) ppm (kg) 50 50 Black 2.0 15.0 30 200 60 85.7 vulture Golden 4.54 5.0 22.7 151 45.4 64.8 Eagle Black-Billed 0.18 1.0 0.18 1.2 0.36 0.51 Magpie Coyote 11.4 0.1 1.14 7.6 2.28 3.25 Skunk 3.18 1.0 3.18 21.2 6.36 9.08 Muscle Tissue Most species would have to consume considerabl e contaminated tissue, relative to their body weig ht, to obtain a lethal dose. For example, black vulture, golden eagle, and black-bille d magpie would have to consume 100×, 33×, and 6.6× their body23 we ights, respectively, to obtain an LD dose from muscle tissue

. 50 Even a coyote, the most sensitive species tested, would have to eat approximately 67% of its body weight to get an LD dose. 50 Stomach Contents Black vulture, golden eagle, and black-billed magpie would have to consume 30×, 10× and 2× their body weight , respectively, to obtain an LD dose from stomach contents

. 50 Because of the higher concentrations in stomach contents, specie s that feed primar

ily on the viscera may be at greater risk than those that feed primarily on muscle. Vomitus Clinical observations suggest that sodium fluoroacetate i s emetic especially

to canids which have ingested more than an LD 50 [Ward and Spencer, 1947 and Texas A&M University Syste m (T AMUS), 1983]. Observations of coyote behavior made durin g the TA MUS study also found that some coyotes would cache th e vomitus, which may furt

her reduce exposure to animals that would otherwis e eat it. Connolly (1980) reported that concentrations i n vomitus of

four poisoned coyotes ranged from below the detection limit (0.1 ppm) to 0.72 ppm. The average conce ntration in vomitus from fiv e coyotes that attacked sheep wearing the 30 ml collar has been reported to be 0.35 ppm (USDA/APHIS, Unpub lished Report, 1986). These levels may be toxic to certain species that are ver y sensitive to sodium fluoroacetate; however, the Agency consider s it unlikely that sufficiently large amounts of vomitus would b e available or found by non-target animals under field conditions to exceed the Agency's risk criteria. For example, the coyote would have to c onsume about 29% of its body weight to obtain a LD 50 equivalent from vomitus

. The skunk would have to consume 280% of its body weight. Burns et al. (1986) also studied residues in coyotes kille d wit h single drop baits (SDBs) treated at 5 mg/bait. They foun d average concentrations of 0.29 ppm for mus cle, 0.30 ppm for small intestine, and 0.31 ppm for stomach. They concluded that thes e valu es were consistent with those found in the 30 ml sodiu m fluoroacetate

livestock protection collars study conducted b y Connolly (1980). They also conducted a series of feeding tests to determine if there was any potential for secondary hazard to non

target animals that fed on coyotes poisoned by the SDBs. All of the24 re moved tissue except the gastrointestinal tract was fed to 3 dog s ( Ca nis familiaris

), 3 coyotes, 4 striped skunks and 15 magpies for periods ranging from 14 to 35 days. The total amount o f con taminated tissue consumed, and expressed as percent of bod y weight averaged 67% for dogs, 152% for coyotes, 117 % for skunks and 371% for the magpies. None of the test species exhibited any signs of sodium fluoroacetate poisoning or had any detectabl e sodium f luoroacetate residues in there tissues. Again, these dat a indicate that even if non

-target species feed on carcasses of coyotes killed by the collar, it is highly unlikely that they will inges t sufficien t quantities of contaminated tissue to result in a secondary hazard. Finally, the U.S. Fi sh and Wildlife Service was required to ev aluate secondary hazard to non-target organisms resulting fro m use of the 30 ml sodium fluoroacetate livestock protection collars. To simulate secondar

y poisoning, coyotes were administered doses of 4 mg, 100 mg, and 400 mg of sodium fluoroacetate. Upo n dea th, all the coyotes were skinned and eviscerated and all muscle tiss ue was removed from the skeletons. All the tissue except th e gastroin testinal tract was ground up and fed to stripped skunks , raccoo ns and opossums. The results indicated that only th e carcasses of animals that had recei ved more than 200 mg of sodium fluoroacetate would be expected to p lace scavengers at risk and that the only species of sc

avengers that would be expected to be at risk would be those with relatively low tolerance for the chemica l (TAMUS, 1983). The dosages that caused observable effect s greatl y exceeded those administered to the coyote by the sodiu m f l uoroacetate livestock protection collars, indicating that mortality to non-target animals is unl ikely from operational use of the collar. Total Collar Use In add ition to the residue information, it is important t o consider h

ow many collars will typically be used in coyote control oper ations. Based on the results of field studies conducted i n vario us states, it appears that the numbers of collars used and th e amounts of sodium fluoroacetate actually lost to the environmen t are bot h quite low. For example, in the study conducted in Ne w Mexico only 23 of 330 of the c ollars (or 7%) were ever punctured. Of those 23 collars only 5 (or 22%) were punctured by coyote s (Litta uer, 1991). The remaining 18 collars were punctured fro m vegetation or unknown causes.25 Du ring three years of monitoring in Wyoming, Montana , Texa s, and New Mexico only 294 out of 2257 collars (13%) were punct ured and had their contents released. Assuming that eac h collar was completely empt ied, the amount of sodium fluoroacetate released to the environment wo uld be 88.2 grams, or an average of 29.4 g rams/year over the four state area where the collars wer e used. What is even more significant is that only 108 of the 29 4 collars punctured, or 36.7%, were punct ured by coyotes. The total amount of sodium fluoroa cetate released from collars punctured by coyote attacks (assuming that each collar was emptied) was 32. 4 grams or a n average of only 10.8 grams/year over the four stat e ar ea. Nearly as many collars (80 collars or 4%) were puncture d from vegetation and unknown causes as from coyote attacks. Field Studies From 1978 to 1980, the U.S. Fish and Wildlife Servic e co nducted field research in various states to assess primary an d seco ndary hazards from the use of the sodium fluoroacetat e livestock protection collars (Connol ly, 1980). It was found that the pri mary scavenger of collared goats that were killed by coyotes in Texa s were turkey vultures ( Cartharista aura ) and black vultures

, while red-tailed hawks, caracaras and ravens infreq uently scavenged kills. No scave

nging by mammals was observed. In Montana and Idaho, black-billed magpie was the species observed mos t frequently as a scavenger of sheep kil led by coyote. Scavenging by ravens was observed infrequently. In addition the followin g summary is given for primarly poisoning: "I n summary, coyote-killed collared livestock were known to have been scavenged by turkey vultures, black v ultures, magpies, rav ens, red-tailed hawks, caracaras, a skunk and a coyote durin g the present studies. No scavenger was known or believed to have been poisoned. Scavengers ignored the collars and fed instead upon the viscera and muscle

that has been exposed by the killer coyote." Field observations of secondary poisoning studies, c onducted in Texas and Montana showed that turkey vultures were the onl y sca vengers of dead coyotes although numerous other scavenger s such as golden e

agles, ravens, magpies, skunks and other potential scavengers were abundant in the area. From 1981 to 1983, the New Mexico Department o f Agriculture conducted an experimental fi eld program evaluating the26 efficacy and safety of the toxic collar. A total of 330 collars were used over appro

ximately 1,000 days. Twelve collared lambs were attacked, but only 5 collars were actually punctured by predators. A total of 18 collars were accidentally punctured while 21 collar s were lost. Three predators were found dead, two coyote and one bobcat ( Ly nx rufus ). The only non-target animal believed to have been poiso ned during the study was a skunk. The results of thi s study suggest that

exposure of non-target species by feeding on the coyote carcass or the neck area of the collared livestock was low and did not result in any significant adverse effect s (Littauer, 1983). As part of the reg

istration requirements, the USDA/APHIS was required to submit

information on hazard to non-target species resulting from the use of the 30 ml sodium fluoroacetate livestock prot ection collars, collected as a result of use of the device i n Mon tana, Wyoming, New Mexico, South Dakota and Texa s (USDA/APHIS, 1991) . The major findings from the actual use of the c ollar during 1988, 1989 and 1990 as well as a report on th e field and laboratory research conducted from 1978 to 1980 are as follows: The conten

ts of a small portion (13%) of the collars placed on l ivestock were actually released into the environment

. The total amount of sodium fluoroacetate involved in th e release, assuming that each collar was completely emptied, was 88.2 grams. This is an average of 29.4 grams/yea r over the four state area where the collars were used. (N o collars were used in South Dakota.) There were no reports of deaths of non-target animal s associated with the use of the so dium fluoroacetate livestock protection collars during this period. Only limited scavenging occurred on coyote carcasses

. Scavenging

was reported by caracara and two species o f vulture. Livestock carcasses were scavenged by vultures, magpies , ravens, red-tailed hawks, caracaras, skun ks and coyotes, but no ne of these non-target species were known to have bee n poisoned as a result. Sc avenger species tended to feed mainly on viscera an d muscle of hind quarters.27 Of the 13% of the collars that had their contents release d during the time period (or 294 collars), only 5% (10 8 collars) were punctured by coyotes. **(a) Birds**  The chemical is very highly toxic to birds on a n acu te oral basis. Certain bird species may be exposed , primarily as a result of scavenging t he carcasses of livestock be aring the sodium fluoroacetate livestock protectio n collars. The risks are d

iscussed in detail above, generically for nontarget avian scavengers and nontarget mammalia n scav engers. The concerns for risk to wildlife can b e addressed with the environmen tal hazard statements, special use restrictions, and endangered species protectio n statements, that are required to be placed on the label. **(b) Mammals**  The chemical is very highl y toxic to mammals on an acute oral basis. Certain specie s may be exposed, primarily as a result of scavenging the carcasses of livestock bearing the sodium fluoroacetate livestock protection collars. Th e risks are discussed in detail a bove, generically for nontarget avian scavengers and nontarget mammalian scavengers

. The conc erns for risk to wildlife can be addressed wit h environmentalhazard statements, special use restrictions , and endangered species protection statements, that ar e required to be placed on the label. **(c) Insects**  Su bstantial exposure of nontarget insects is no t ant icipated from the use of the sodium fluoroacetat e livestock protection collars. **(2) Exposure and Risk to Nontarget Aquatic Animals**  Based on low toxicity to aquatic animals and low exposure associated with use of the sodium fluoroacetate livestock protection collars, the Agency finds that use o f the collar is not likely to result in unacceptable ris

k. Sodium fluoroacetate is practically non-toxic to warmwater fish species and aquatic invertebrates, and onl y28 slightly toxic to col dwater fish species. The Agency does not have reports of detections in surface or ground water.
**(3) Exposure and Risk to Nontarget Plants**  Evaluation

of exposure and risk is not required fo r terre strial, semiaquatic, or aquatic plants because sodiu m fluoroacetate is not a herbicide and is not applied aerially, and there is no other apparent basis for a phytotoxicity concern. **(4) Endangered Species**  On March 21, 1985, the Agency requested formal Sectio n 7 consultation relative to the Un ited States Department of Interior's ap plication to register compound sodium fluoroacetate livestoc k protection collar. On June 14, 1985, the U. S. Fish and Wildlife Service - Office of Endangered Species (USFWS-OES) responded and concluded that the use of the sodium fluoroacetate collar with propos ed use directions and restrictions posed no jeopardy to th e bald eagle, San Joaquin kit fox, black-footed ferret ( Mustel a nigripes ), and gray wolf ( Can

is lupus ), but was likely to jeopardize the continued existence of the grizzly bear (Ursus arctos horribilus ), Rocky Mountain wolf ( Canis lupus irremotus ) and Californi a condor ( Gymn

ogys californianus

) (USFWS, 1985). The USFWSOES provided specific state and county recommendations fo r avoiding adverse effects to the non-jeopardy species as well a s reasonable

and prudent alternatives for precluding jeopardy to the three species in jeopardy from the use pattern. Based on thes e rec ommendations, the Agency developed specific endangere d species label precautions and use restrictions for the 30 ml collar. These use restrictions have been included in a Technical Bulleti n that accompanies the labeling. In 1987 , as a result of informal consultation with fiel d operations personnel from the USFWS, the Agency became aware that ad ditional precautions, specifically addressing the use of th e sodiu m fluoroacetate livestock protection collars in Texas, wer e required to prot

ect the ocelot ( Felis pardalis ) and jaguarundi ( Felis yagoua rundi cacomitei ) (USFWS, 1986). The additional us e precauti ons

were reviewed by the Agency and included in th e Technical Bulletin.29 In March 1993 the USFWS issued a final biological opinion on the effects of 16 vertebrate control agents on threatened an d en dangered species. This opinion specifically addressed th e livestock prote

ction collar and included jeopardy determinations to the gray wolf and grizzly bear. It did not conclude jeopard y determinations to any other species. Th e USFWS identified specific areas where the collar could not be used and concluded tha t impleme ntation of such a restriction would preclude jeopardy t o both the g raph wolf and the grizzly and that no incidental tak e would occur from the use of the collar. Suc h restrictions have been incorporated on the livestock protection collar labels. **IV. RISK MANAGEMENT AND REREGISTRATION DECISION**  **A. Determination of Eligibility**  Section 4 (g)(2)(A) of FIFRA calls for the Agency to determine, after submission of relevant data concerning an active ingredient, whether products containing the active ingr edients are eligible for reregistration. The Agency has previously identified an d required the submission of the generic (i.e. active ingredient specific) data required t o support reregistration of products containing sodiu m fluoroacetate active ingredients. The A g ency has completed its review of these generic data, and has determined that the data are sufficient to support reregistration of all products containing sodium fluoroacetate

. Appendi x B identifies the generic data requirements that the Agency reviewed as part of its determination of reregistration eligibility of sodium fluoroacetate, and lists th e submitted studies that the Agency found acceptable. The data identified in Appendix B were sufficient to all ow the Agency to assess the registered uses of sodium fluoro acetate and to determine that sodium fluoroacetate can be us ed without resulting in unreasonable adverse effects to humans and the environment

. The A gency, therefore, finds that all products containing sodium fluoroacetate as th e active ingredients are eligible for reregistration. The reregistration of particular products is addressed in Section V of this document. The Agency made its reregis tration eligibility determination based upon the target da ta base required for reregistration, the current guidelines for conducting acceptabl e studies to generate such data, publ ished scientific literature, etc. and the data identified in Appendix B. Although the Age ncy has found that all currently registered uses of sodium fluoroacetate ar

e eligible for reregistration, it should be understood that the Agency may take appro priate regulatory action, and/or require the submission of additional data t o suppo rt the registration of products containing sodium fluoroacetate if new informatio n comes to the Agency's attention or if the data requirements for registration (or th e guidelines for generating such data) change.30 As described in the Regulatory History and Status section of this document (Section II.E.), and in 40 CFR Part 164 , Subpart D, new predicidal uses for sodium fluoroacetate cannot be g ranted without submission by the applicant of new evidence which was no t availa ble and which could have impacted the outcome of the decision in 1972 by th e Administrator to cancel the predi cidal uses, and without a hearing involving all interested parties.

**1. Eligibility Decision** 

Based on the reviews of the generic data for the active ingredient sodium fluoroacetate, the Agency has sufficient information on the health effects of sodium fluoroace tate and on its potential for causing adverse effects in fish and wildlif e and the environment. The Agency has determined that sodium fluoroacetate pr oducts, labeled and used as specified in this Reregistration Eligibility Decision, will not pos e unreasonable risks or adverse effects to humans or the envi ronment. Therefore, the Agency concludes that products c ontaining sodium fluoroacetate registered for the sole remaining use are eligible for reregistration. **2. Eligible and Ineligible Uses**  The Agency has determined that the single currently registered use o f sodium fluoroacetate is eligible for reregistration. **B. Regulatory Position**  The following is

a summary of the regulatory positions and rationales for sodium fluoroacetate. Where labeling revisions are imposed, specific language is set forth i n Section V of this document. **1. Restricted Use Classification**  Sodi um fluoroacetate, which is only registered for use in livestoc k protectio n collars, will retain the restricted use classification imposed by th e Agency in 1978 due to its high acute toxicity and the need for highly specialized applicator training. **2. Endangered Species Statement**  The Agency has concerns about the expos ure of threatened and endangered animal species to sodium fluoroacetate as discussed above i n the science assessment chapter.31 At this time no further measures are necessary for p rotection of endangered species. Should the use of sodium fluoroacetate change or the Agency become s aware of new information tha t would warrant new concerns, the Agency will take additional action as necessary. **V. ACTIONS REQUIRED OF REGISTRANTS**  This sectio

n specifies the data and labeling requirements and responses necessary for the reregistration of both manufacturing-use and end-use products. **A. Manufacturing-Use Products**  **1. Additional Generic Data Requirements**  The generic data base supporting the reregistration of sodium fluoroacetate for the above eligible use has been reviewed and determined to be substantiall y complete. **2. Labeling Requirements for Manufacturing-Use Products**  To re main in compliance with FIFRA, manufacturing use product (MP ) labeling must be revised to comply with all current EPA regulations, PR Notices and applicable policies. The MP labeling must bear the following statement under Directions for Use: "For use only for reformulating into sodium fluoroacetate solutions for use only in Federally-registered livestock protection collars". **B. End-Use Products**  **1. Additional Product-Specific Data Requirements**  Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any neede d product-specific data regarding the pesticide after a det ermination of eligibility has been made. The produc

t specific data requirements are listed in Appendix G, the Product Specific Data Call-In Notice. Registrants must review previous data su bmissions to ensure that they meet cu rrent EPA acceptance criteria (Appendix F; Attachment E) and if not, commit to conduct new studies. If a registrant believes that pr eviously submitted data meet current testing standards, then study MRID numbers should be cited according to the instructions in the Requirement Status and Registrants Response Form provided for each product."Direct Supervision," as described in this restriction, conforms to the requirements 1 established under 40 CFR 171.6. 32

**2. Labeling Requirements for End-Use Products**  The use of sodium fluoroacetate in th e animal protection collar is currently register ed in five states (Montana, New Mexico, South Dakota, Texas, an d Wyoming). The following list of use restrictions for sodium fluoroa cetate represents the USDA/APHIS product. The labels and labeling of all products must comply with EPA's curren t regulations and requirements as specified in 40 CFR §156.10 and other applicable notices. USE RESTRICTIONS 1. Use

o f livestock protection (LP) collars shall conform to all applicabl e Federal, State, and local regulations. 2. LP

Collars shall be sold or transferred only by registrants or their agents and only to certified Liv

estock Protection Collar applicators. Collars may be used only by specifically certified Livestock Protection Colla r applicators or by persons under their direct supervision. 1 The certified applicator is directly responsible for assuring that all us e restricti ons

are met. The certified applicator will decide, in accordanc e with label directions, when and under what circumstances collars will b e used. The certified applicator will either apply collars or be physicall y prese nt where collars are applied by a noncertified person. However, a noncertified person who has received adequate instructions from th e certified applicator may store collars, check collars in the field, remov e collars , repair or dispose of damaged collars in accordance with us e restrictions, retrieve collars laying in the field and properly dispose o f contaminated material and animal carcasses. 3. Certifi cation

of applicators shall be performed by appropriate regulator y agencies. Prior to certification, each applicator shall receive training which will include, but need not be limited to: (a) Training in safe handling and attachment of LP collars.33 (b) Trainig

in disposal of punctured or leaking LP collars, an d contaminated animal remains, vegetation, soil, and clothing. (c) Instructions for practical treatment of 1080 poisoning in human s and domestic animals. (d) Instructions on record keeping. 4. Registra

nts or their agents shall keep records of all collars sold o r tran sferred at their address of record. Records shall include the name , address, state where Livestock Protection Collar certification was issued, certifi cation

number of each recipient, and dates and numbers of collar s sold or transferred. 5. Each ap

plicator shall keep records dealing with the use of LP Collars and the r esults of such use. Records shall be maintained in accordance wit h appropr iate State or Federal regulations but for not less than two year s following disposal or loss of collar. Such records shall include, but need not be limited to: (a) The number of LP collars attached on livestock. (b) The pasture(s) where LP collared livestock were placed. (c) The dates of each attachment, inspection, and removal (d) Th

e number and locations of livestock found with ruptured o r punctured LP collars and the apparent cause of the damage. (e) The number, dates, and approximate location of LP collars lost. (f) The

spec ies, locations, and dates of all suspected poisonings o f humans, domestic animals or non-target wild animal s resulting from LP collar use. 6. An

y suspected poisoning of threatened or endangered species must b e report ed immediately (within three days) to the Environmental Protection Agency, as will

each suspected poisoning of humans, domestic animals or no n-target wild animals. The person to contact at the Environmenta l Protection Agency is Robert A. Forrest (PM-14), Registration Divisio n (7505C), 401 M Street, SW, Washington, DC 20460. 7. Only

the registrant or collar manufacturer is authorized to fill LP collars with 1080 solution. Certified applicators are not authorized to fill L P collars

. Compound 1080 solution may not be removed from collars an d used for any other purpose.Fenced pastures include all grazing land that is enclosed by livestock fencing. This includes 2 wire or other man-made fences such as rock walls, and natural barriers such as escarpments, lakes, and large rivers that will prevent the escape of livestock. 34 8. LP

Collars shall only be used to take coyotes within fenced pastures n o 2 larger than 2,560 acres (4 square miles). But where average annua l precipitation does not exceed 20 inches and vegetation is sparse, consisting only of short to mid-height grasses and scattered shrubs, collars may b e used i n pastures up to a maximum of 10,000 acres (16 square miles) i n size. In no case shall the applicator place LP collared livestock in pastures wher e co mpliance with other Use Restrictions, such as monitoring, is impossible; i n fenced pastures larger than 10,000 acres; or in unfenced, open range. 9. LP

Collars shall be used only where losses of sheep or goats due t o predation by coyotes are occurring or , based upon prior experience, where coyote predation can reasonably be expected to occur. 10. Where LP collars are in use, each logical point of access (for example , roads, g ates, and trails) shall be conspicuously posted with a bilingua l (En glish/Spanish

or other second language appropriate for the region ) warning sign not less than 8" X 10" in size. Signs shall be inspected weekly to ensure their continued presence and legibility and will be removed when collar s are removed. The signs will have a minimum type size fo r "DANGER-POISON" of 24 point (1/4 inches), with remaining text at least 18 point (3/16 inches). 11. All

LP collared livestock must be checked at least once every seven days and collars adjusted if needed. If any LP collared animal is not accounted for in two consecutive checks, an intensive search for it must be made. In addition, if more than three LP collared animals are not accounted for during any one

check, an intensive search for these animals is required. If more th an nine (9) LP collars are unaccounted for during any 60 da y per iod, remove all collars from animals and terminate their use. Do no t resum e use until adequate steps have been taken to prevent further, excessive loss of collars.35 12. Damaged, punctured, or leaking LP collars shall be removed from the field for repair or proper disposal. Damaged collars shall be placed individually in leakproof containers while awaiting repair or proper disposal

. Authorize

d collar repairs are limited to minor repairs of straps an d fastenings. Leaking or punctured collars must be properly disposed. 13. Dispose of 1080 wastes (p unctured, leaking, or otherwise unrepairable LP co llars; contaminated leather clothing, animal remains, wool, hair, vege tation, water, and soil) under three feet of soil, at a safe location , preferably on property owned or managed by the app licator and at least 1/2 mile from hu

man habitations and water supplies. No more than 10 collars may be buried

in any one hole. lf buried in a trench, each group of 1 0 collars must be at least 10 feet apart. Incine ration may be used instead of burial for disposal in the fiel d (preferably on property owned or managed by the applicator) at least 1/2 mile from human habitation and water su pplies. Place collars and waste (listed above) in an incinerator or refuse hole, saturate with diesel fuel, and ignite. Attend the burn until the contaminated material is completel y consumed. Al ternatively, contact your State Pesticide or Environmental Contro l Agency or the Hazardous Waste representative at the nearest EPA Regional Office for guidance in disposing of wastes at approved hazardous wast e disposal facilities. When snow or frozen

ground make on-site disposal impractical, up to one cubic foot of wastes may be stored in a leak-proof container in a dry , locked place for 90 days. Metal Container: Triple rinse c ontaminated and uncontaminated containers with water. Punctu

re and dispose of contaminated container and rinsate as above. Plastic Container: Triple rinse with water. Then puncture and dispose o f container and rinsate as above. 14. All persons authorized to possess and use LP Collars shall store them under l o ck and key in a dry place away from food, feed, domestic animals, and corrosiv e chemicals and in outbuildings, or in outdoor storage area s attached to, but separate from human living quarters.36 15. Provisions for the protection of endangered species: The LP Colla

r may not be used in the following areas due to potentia l adverse effects to endangered species (California condor). STATE COUNTIES California Fresno, Kern, Kings, Los Angeles, Monterey, Sa n Luis Obispo, Santa Barbara, Tulare, and Ventura The LP colla

r may not be used in the following areas without written approva l from the nearest U.S. Fish and Wildlife Service Office (FWS, Endangered Species Specialists). If FWS or the user determines that the use of collars may adversely im pact an endangered species (San Joquin kit fox, black-footed ferret, Norther n Rocky Mountain wolf, or Grizzly bear) in the specific areas requested, collars may not be used in these areas. Written approval must be obtained annually.
State Counties or Area NEAREST FWS OFFICE/ PHONE
California Alameda, Contra Costa, Sacramento, CA

Merced, San Joaquin, 916-978-4866 Santa Clara, and Satnislaus Idaho Bonner, Boise (north of Boise, ID

State Highway 21), 208-334-1931 Boundry, Clearwater, Custer (north of local road running from Sun Valley to Chilly and a corresponding line northeast from Chilly to Patterson), Fremont, Idaho, Lemhi, Shosshone, and Valley Michigan Keweenaw (Isle Royal) and Twin Cities, MN

entire Upper Peninsula 612-725-3276State Counties or Area NEAREST FWS OFFICE/ PHONE

37 Minnesota Aitkin, Becker, Beltrami, Twin Cities, MN

Carlton, Cass, Clearwater, 612-725-3276 Cook, Crow Wing, Hubbard, Itasca, Kittson, Koochiching, Lake, Lake of the Woods, Mahnomen, Marshall, Pennington, Pine Roseau, and St. Louis
Montana Beaverhead, Carbon, Helena, MT

Flathead, Gallatin, Glacier, 406-449-5322 Lake, Lewis and Clark, Lincoln, Madison, Missoula, Park, Pondera, Powell, Sanders, Stillwater, Sweet Grass, and Teton Washington Pend Orielle, Okanogan, Boise, ID

(National Park and Forrest 208-334-1931 Land), Skagit, and Whatcom Wisconsin Douglas, Florence, Twin Cities, MN

Lincoln, Oneida, and Price 612-725-3276 Wyoming Fremont, Park, and Teton Helena, MT

and Yellowstone National 406-449-5322 Parks 16. The

numbe r of LP collars used shall be the minimum necessary fo r effective livestock protection. For pastures of the following size classes, do not use more collars than the number indicated. Size (acres) Number of Collars up to 100 20 101 to 640 50 641 to 10,000 10038 17. Each applica

tor will have a one-ounce bottle of syrup of ipecac (to induce vomiting in case of accidental poisoning) available when attaching , inspecting, removing, or disposing of LP collars. 18. No contaminated animal will be used for food or feed. In addition, for State-limited products, additional use restrictions consistent with EP A's regulatory position and legal decisions regarding predacidal uses of sodiu m fluoroacetate

may be added. The organization of restrictions may be altered so as t o maintain consistency with applicable State and Federal laws and regulations but n o requirements

may be dropped or mitigated. Any changes to the use restrictions must be requested

through the amendment process and must be accepted by the U.S

. Environmental Protection Agency before they may be incorporated into the labeling o f product released for shipment in the U.S. Unless the Agency specifically indicates otherwise, the current accepted labeling for registered 1080 Livestock Protection Collar products remains acceptable. The re gistrants should submit 5 copies of their last accepted labeling (all 3 componets

thereof) with their 8-months responses. The Agency will then review th e documents to determine whether any changes are needed. **C. Existing Stocks**  R e gistrants may generally distribute and sell products bearing old labels/labeling for 26 mont

hs from the date of the issuance of this Registration Eligibility Decisio n (RED). Persons other than the registrant may generally distribute or sell such products for 50 months from t

he date of the issuance of this RED. However, existing stocks time fr ames will be established case-by-case, depending on the number of products involved, the number of label changes, and other factors. Refer to "Existing Stocks of Pesticid e Products; Statement of Policy"; Federal Register , Volume 56, No. 123, June 26, 1991. The Agency has determined that registrants may distribute and sell sodiu m fluoroacetate

products bearing old labels/labeling, i.e., labels absent the modification s specified in this RED document, except as noted below, for 26 months from the date of issuance of this RED. Registrants and persons other than the registrants remain obligated to meet preexisting Agency imposed label changes and existing stocks requirement s applicable to your products.39 

# VI. APPENDICES40 **APPENDIX A. Table of Use Patterns Subject to Reregistration** Report Run Date: 05/01/95 ) Time 12:06 APPENDIX A ) CASE 3073, [Fluoroacetic acid derivs.] Chemical 075003 [Sodium fluoroacetate] LUIS 2.0 ) Page 1 PRD Report Date: 01/20/95 4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444 SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)] cycle

USES ELIGIBLE FOR REREGISTRATION FOOD/FEED USES ))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))) DAIRY GOATS (LACTATING OR UNSPECIFIED) Use Group: INDOOR FOOD Animal treatment (rubber bladder collar)., FM/L NA 6.650E-04 lb * NS NS NS NS NS NS 013 C20, CAL When needed., Glove. collar Geo.013: The collar may not be used in the following California counties due to potential adverse effects to endangered species (California condor): Fresno, Kern, Kings, Los Angeles, Monterey, San Benito, San Luis Obispo, Santa Barbara, Tulare, and Ventura. The collar may be used in various counties (see label for specific counties) of the following states: California, Idaho, Michigan, Minnesota, Montana, Washington, Wisconsin, and Wyoming. Written approval, on an annual basis, must be obtained from the U.S. Fish and Wildlife Service Office prior to use in these states. FM/L NA 6.650E-04 lb * NS NS NS NS NS NS MT C20, CAL collar FM/L NA 6.708E-04 lb * NS NS NS NS NS NS NM C20, CAL collar FM/L NA 6.708E-04 lb * NS NS NS NS NS NS SD C20, CAL collar FM/L NA 6.708E-04 lb * NS NS NS NS NS NS TX C20, CAL collar FM/L NA 6.708E-04 lb * NS NS NS NS NS NS WY C20, CAL collar GOATS (MEAT) Use Group: INDOOR FOOD Animal treatment (rubber bladder collar)., FM/L NA 6.650E-04 lb * NS NS NS NS NS NS 013 C20, CAL When needed., Glove. collar Geo.013: The collar may not be used in the following California counties due to potential adverse effects to endangered species (California condor): Fresno, Kern, Kings, Los Angeles, Monterey, San Benito, San Luis Obispo, Santa Barbara, Tulare, and Ventura. The collar may be used in various counties (see label for specific counties) of the following states: California, Idaho, Michigan, Minnesota, Montana, Washington, Wisconsin, and Wyoming. Written approval, on an annual basis, must be obtained from the U.S. Fish and Wildlife Service Office prior to use in these states. FM/L NA 6.650E-04 lb * NS NS NS NS NS NS MT C20, CAL collar FM/L NA 6.708E-04 lb * NS NS NS NS NS NS NM C20, CAL collar FM/L NA 6.708E-04 lb * NS NS NS NS NS NS SD C20, CAL collar FM/L NA 6.708E-04 lb * NS NS NS NS NS NS TX C20, CAL collar41 Report Run Date: 05/01/95 ) Time 12:06 APPENDIX A ) CASE 3073, [Fluoroacetic acid derivs.] Chemical 075003 [Sodium fluoroacetate] LUIS 2.0 ) Page 2 PRD Report Date: 01/20/95 4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444 SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)] cycle

USES ELIGIBLE FOR REREGISTRATION FOOD/FEED USES (con't) ))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))) GOATS (MEAT) (con't) Use Group: INDOOR FOOD (con't) FM/L NA 6.708E-04 lb * NS NS NS NS NS NS WY C20, CAL collar KIDS (MEAT) Use Group: INDOOR FOOD Animal treatment (rubber bladder collar)., FM/L NA 6.650E-04 lb * NS NS NS NS NS NS 013 C20, CAL When needed., Glove. collar Geo.013: The collar may not be used in the following California counties due to potential adverse effects to endangered species (California condor): Fresno, Kern, Kings, Los Angeles, Monterey, San Benito, San Luis Obispo, Santa Barbara, Tulare, and Ventura. The collar may be used in various counties (see label for specific counties) of the following states: California, Idaho, Michigan, Minnesota, Montana, Washington, Wisconsin, and Wyoming. Written approval, on an annual basis, must be obtained from the U.S. Fish and Wildlife Service Office prior to use in these states. FM/L NA 6.650E-04 lb * NS NS NS NS NS NS MT C20, CAL collar FM/L NA 6.708E-04 lb * NS NS NS NS NS NS NM C20, CAL collar FM/L NA 6.708E-04 lb * NS NS NS NS NS NS SD C20, CAL collar FM/L NA 6.708E-04 lb * NS NS NS NS NS NS TX C20, CAL collar FM/L NA 6.708E-04 lb * NS NS NS NS NS NS WY C20, CAL collar LAMB (MEAT) Use Group: INDOOR FOOD Animal treatment (rubber bladder collar)., FM/L NA 6.650E-04 lb * NS NS NS NS NS NS 013 C20, CAL When needed., Glove. collar Geo.013: The collar may not be used in the following California counties due to potential adverse effects to endangered species (California condor): Fresno, Kern, Kings, Los Angeles, Monterey, San Benito, San Luis Obispo, Santa Barbara, Tulare, and Ventura. The collar may be used in various counties (see label for specific counties) of the following states: California, Idaho, Michigan, Minnesota, Montana, Washington, Wisconsin, and Wyoming. Written approval, on an annual basis, must be obtained from the U.S. Fish and Wildlife Service Office prior to use in these states. FM/L NA 6.650E-04 lb * NS NS NS NS NS NS MT C20, CAL collar FM/L NA 6.708E-04 lb * NS NS NS NS NS NS NM C20, CAL collar42 Report Run Date: 05/01/95 ) Time 12:06 APPENDIX A ) CASE 3073, [Fluoroacetic acid derivs.] Chemical 075003 [Sodium fluoroacetate] LUIS 2.0 ) Page 3 PRD Report Date: 01/20/95 4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444 SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)] cycle

USES ELIGIBLE FOR REREGISTRATION FOOD/FEED USES (con't) ))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))) LAMB (MEAT) (con't) Use Group: INDOOR FOOD (con't) FM/L NA 6.708E-04 lb * NS NS NS NS NS NS SD C20, CAL collar FM/L NA 6.708E-04 lb * NS NS NS NS NS NS TX C20, CAL collar FM/L NA 6.708E-04 lb * NS NS NS NS NS NS WY C20, CAL collar SHEEP (MEAT) Use Group: INDOOR FOOD Animal treatment (rubber bladder collar)., FM/L NA 6.650E-04 lb * NS NS NS NS NS NS 013 C20, CAL When needed., Glove. collar Geo.013: The collar may not be used in the following California counties due to potential adverse effects to endangered species (California condor): Fresno, Kern, Kings, Los Angeles, Monterey, San Benito, San Luis Obispo, Santa Barbara, Tulare, and Ventura. The collar may be used in various counties (see label for specific counties) of the following states: California, Idaho, Michigan, Minnesota, Montana, Washington, Wisconsin, and Wyoming. Written approval, on an annual basis, must be obtained from the U.S. Fish and Wildlife Service Office prior to use in these states. FM/L NA 6.650E-04 lb * NS NS NS NS NS NS MT C20, CAL collar FM/L NA 6.708E-04 lb * NS NS NS NS NS NS NM C20, CAL collar FM/L NA 6.708E-04 lb * NS NS NS NS NS NS SD C20, CAL collar FM/L NA 6.708E-04 lb * NS NS NS NS NS NS TX C20, CAL collar FM/L NA 6.708E-04 lb * NS NS NS NS NS NS WY C20, CAL collar NON-FOOD/NON-FEED ))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))) GOATS (WOOL/ANGORA ANIMAL) Use Group: INDOOR NON-FOOD43 Report Run Date: 05/01/95 ) Time 12:06 APPENDIX A ) CASE 3073, [Fluoroacetic acid derivs.] Chemical 075003 [Sodium fluoroacetate] LUIS 2.0 ) Page 4 PRD Report Date: 01/20/95 4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444 SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)] cycle

USES ELIGIBLE FOR REREGISTRATION NON-FOOD/NON-FEED (con't) ))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))) GOATS (WOOL/ANGORA ANIMAL) (con't) Use Group: INDOOR NON-FOOD (con't) Animal treatment (rubber bladder collar)., FM/L NA 6.650E-04 lb * NS NS NS NS NS NS 013 C20, CAL When needed., Glove. collar Geo.013: The collar may not be used in the following California counties due to potential adverse effects to endangered species (California condor): Fresno, Kern, Kings, Los Angeles, Monterey, San Benito, San Luis Obispo, Santa Barbara, Tulare, and Ventura. The collar may be used in various counties (see label for specific counties) of the following states: California, Idaho, Michigan, Minnesota, Montana, Washington, Wisconsin, and Wyoming. Written approval, on an annual basis, must be obtained from the U.S. Fish and Wildlife Service Office prior to use in these states. FM/L NA 6.650E-04 lb * NS NS NS NS NS NS MT C20, CAL collar FM/L NA 6.708E-04 lb * NS NS NS NS NS NS NM C20, CAL collar FM/L NA 6.708E-04 lb * NS NS NS NS NS NS SD C20, CAL collar FM/L NA 6.708E-04 lb * NS NS NS NS NS NS TX C20, CAL collar FM/L NA 6.708E-04 lb * NS NS NS NS NS NS WY C20, CAL collar SHEEP Use Group: INDOOR NON-FOOD Animal treatment (rubber bladder collar)., FM/L NA 6.650E-04 lb * NS NS NS NS NS NS 013 C20, CAL When needed., Glove. collar Geo.013: The collar may not be used in the following California counties due to potential adverse effects to endangered species (California condor): Fresno, Kern, Kings, Los Angeles, Monterey, San Benito, San Luis Obispo, Santa Barbara, Tulare, and Ventura. The collar may be used in various counties (see label for specific counties) of the following states: California, Idaho, Michigan, Minnesota, Montana, Washington, Wisconsin, and Wyoming. Written approval, on an annual basis, must be obtained from the U.S. Fish and Wildlife Service Office prior to use in these states. FM/L NA 6.650E-04 lb * NS NS NS NS NS NS MT C20, CAL collar FM/L NA 6.708E-04 lb * NS NS NS NS NS NS NM C20, CAL collar FM/L NA 6.708E-04 lb * NS NS NS NS NS NS SD C20, CAL collar FM/L NA 6.708E-04 lb * NS NS NS NS NS NS TX C20, CAL collar44 Report Run Date: 05/01/95 ) Time 12:06 APPENDIX A ) CASE 3073, [Fluoroacetic acid derivs.] Chemical 075003 [Sodium fluoroacetate] LUIS 2.0 ) Page 5 PRD Report Date: 01/20/95 4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444 SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)] cycle

USES ELIGIBLE FOR REREGISTRATION NON-FOOD/NON-FEED (con't) ))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))) SHEEP (con't) Use Group: INDOOR NON-FOOD (con't) FM/L NA 6.708E-04 lb * NS NS NS NS NS NS WY C20, CAL collar45 Report Run Date: 05/01/95 ) Time 12:06 APPENDIX A ) CASE 3073, [Fluoroacetic acid derivs.] Chemical 075003 [Sodium fluoroacetate] LUIS 2.0 ) Page 6 PRD Report Date: 01/20/95 4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
LEGEND 444444
HEADER ABBREVIATIONS Min. Appl. Rate (AI unless : Minimum dose for a single application to a single site. System calculated. Microbial claims only. noted otherwise) Max. Appl. Rate (AI unless : Maximum dose for a single application to a single site. System calculated. noted otherwise) Soil Tex. Max. Dose : Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only). Max. # Apps @ Max. Rate : Maximum number of Applications at Maximum Dosage Rate. Example: "4 applications per year" is expressed as "4/1 yr"; "4 applications per 3 years" is expressed as "4/3 yr" Max. Dose [(AI unless : Maximum dose applied to a site over a single crop cycle or year. System calculated. noted otherwise)/A] Min. Interv (days) : Minimum Interval between Applications (days) Restr. Entry Interv (days) : Restricted Entry Interval (days) PRD Report Date : LUIS contains all products that were active or suspended (and that were available from OPP Document Center) as of this date. Some products registered after this date may have data included in this report, but LUIS does not guarantee that all products registered after this date have data that has been captured.
SOIL TEXTURE FOR MAX APP. RATE * : Non-specific C : Coarse M : Medium F : Fine O : Others
FORMULATION CODES FM/L : FORM NOT IDENTIFIED/LIQUID
ABBREVIATIONS AN : As Needed NA : Not Applicable NS : Not Specified (on label) UC : Unconverted due to lack of data (on label), or with one of following units: bag, bait, bait block, bait pack, bait station, bait station(s), block, briquet, briquets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser, drop, eartag, grains, lure, pack, packet, packets, pad, part, parts, pellets, piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick, strip, tab, tablet, tablets, tag, tape, towelette, tray, unit, --
APPLICATION RATE DCNC : Dosage Can Not be Calculated No Calc : No Calculation can be made W : PPM calculated by weight V : PPM Calculated by volume U : Unknown whether PPM is given by weight or by volume cwt : Hundred Weight nnE-xx : nn times (10 power -xx); for instance, "1.234E-04" is equivalent to ".0001234"
USE LIMITATIONS CODES C20 : Endangered species restriction. CAL : Do not contaminate water, food or feed. * NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
GEOGRAPHIC CODES 013 : Other MT : Montana NM : New Mexico46 Report Run Date: 05/01/95 ) Time 12:06 APPENDIX A ) CASE 3073, [Fluoroacetic acid derivs.] Chemical 075003 [Sodium fluoroacetate] LUIS 2.0 ) Page 7 PRD Report Date: 01/20/95 4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444 GEOGRAPHIC CODES (Cont.) SD : South Dakota TX : Texas WY : Wyoming47

**APPENDIX B.**  **Table of the Generic Data Requirements and Studies Used to Make the**  **Reregistration Decision GUIDE TO APPENDIX B**  Appen dix B contains listings of data requirements which support the reregistration for active ing redients within the case SODIUM FLUOROACETATE covered by this Reregistratio n Eli gibility

Decision Document. It contains generic data requirements that apply to SODIU M FLUOROACETATE in all products, including data requirements for which a "typica l formulation" is the test substance. The data table is organized in the following format: 1. Data Requirement

(Column 1). The data r

equirements are listed in the order in which they appear in 40 CFR Part 158. the reference numbers accompanying each test refer to the test protocol s set in the Pesticide Assessment Guidelines, which are available from the Nationa l Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650. 2. Use Pa

ttern (Column 2). This column indicates the use patterns for which the dat a requirements apply. The following letter designations are used for the given use patterns: A Terrestrial food B Terrestrial feed C Terrestrial non-food D Aquatic food E Aquatic non-food outdoor F Aquatic non-food industrial G Aquatic non-food residential H Greenhouse food I Greenhouse non-food J Forestry K Residential L Indoor food M Indoor non-food N Indoor medical O Indoor residential 3. Bibliographi c citation

(Column 3). If the Agency has acceptable data in its files, this column l ists the identifying number of each study. This normally is the Master Recor d Identific ation (MRID) number, but may be a "GS" number if no MRID number has bee n assigned. Refer to the Bibliography appendix for a complete citation of the study.48 

# APPENDIX B **Data Supporting Guideline Requirements for the Reregistration of Sodium Fluoroacetate REQUIREMENT**  **USE PATTERN CITATION(S)**  

### PRODUCT CHEMISTRY **61-1 Chemical Identity**  LM 41216101 **61-2A Start. Mat. & Mnfg. Process**  LM 42127401 **61-2B Formation of Impurities**  LM 41216101 **62-1 Preliminary Analysis**  LM 41631701 **62-2 Certification of limits**  LM 41631702 **62-3 Analytical Method**  LM 41631704 **63-2 Color**  LM 42678801 **63-3 Physical State**  LM 42678802 **63-4 Odor**  LM 42678803 **63-5 Melting Point**  LM 41171102 **63-7 Density**  LM 41171103 **63-10 Dissociation Constant**  LM 41171102 **63-12 pH**  LM 41171103 **63-13 Stability**  LM 42678804 **63-17 Storage stability**  LM 41631703 

### ECOLOGICAL EFFECTS **71-1A Acute Avian Oral - Quail/Duck**  LM * **71-2A Avian Dietary - Quail**  LM 43210601 **71-2B Avian Dietary - Duck**  LM 43210602 **71-5A Simulated Field Study**  LM 41958701 **71-5B Actual Field Study**  LM 41514901 **72-1A Fish Toxicity Bluegill**  LM 42961601 **72-1C Fish Toxicity Rainbow Trout**  LM 42961602 **72-2A Invertebrate Toxicity**  LM 42961603 

### TOXICOLOGY **81-1 Acute Oral Toxicity**  LM 40016971, 65627, * **81-2 Acute Dermal Toxicity**  LM 152129 **81-3 Acute Inhalation Toxicity**  LM Waived **81-4 Primary Eye Irritation - Rabbit**  LM 40402603

### Data Supporting Guideline Requirements for the Reregistration of Sodium Fluoroacetate

**REQUIREMENT USE PATTERN**  **CITATION(S)**

49 **81-5 Primary Dermal Irritation - Rabbit**  LM 40402604 **81-6 Dermal Sensitization**  LM Waived **82-1(a) 90-Day Feeding - Rodent**  LM 40016990, * **85-1 General Metabolism**  LM * 

### ENVIRONMENTAL FATE **161-1 Hydrolysis**  LM 61751, 40016958, 40016959 *See Appendix C, Bibliography for citations from the published literature50

**APPENDIX C.**  **Ci tations**  **Considered to be Part of the Data Base Supporting th e**  **Reregistration of Sodium Fluoroacetate GUIDE TO APPENDIX C**  1. CONT ENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studie s considered relevant by EPA in arriving at the positions and conclusions stated elsewhere in the Reregistration Eligibility Document. Primary sources for studies in thi s bibliography

have been the body of data submitted to EPA and its predecessor agencies in support of past regulatory decisions. Selections from other sources including th e published literature, in those instances where they have been considered, are included. 2. UNIT S OF ENTRY. The unit of entry in this bibliography is called a "study". In th e case of p ublished materials, this corresponds closely to an article. In the case o f unpubl ished

materials submitted to the Agency, the Agency has sought to identif y documents

a t a level parallel to the published article from within the typically large r volumes in whic

h they were submitted. The resulting "studies" generally have a distinct title (o r at least a single subject), can stand alone for purposes of review and can b e described with a conventional bibliographic citation. The Agency has also attempted to unite basic documents and commentaries upon them, treating them as a single study. 3. IDENTI FICATION OF ENTRIES. The entries in this bibliography are sorte d numerically by Master Reco rd Identifier, or "MRID number". This number is unique to the citation, and should be used whenever a specific referenc e is required. It is not related to the six-digit "Accession Number" which has been used to identify volumes of submitted st udies (see paragraph 4(d)(4) below for further explanation). In a few cases, entrie s add ed to the bibliography late in the review may be preceded by a nine characte r temporary

id entifier. These entries are listed after all MRID entries. This temporar y identifying number is also to be used whenever specific reference is needed. 4. FORM

OF ENTRY. In addition to the Master Record Identifier (MRID), each entr y consis ts of a citation containing standard elements followed, in the case of materia l submitted to EPA, by a description of the earliest known submission. Bibliographi c conventions used reflect the standard of the American National S tandards Institute (ANSI), expanded to provide for certain special needs.

a Autho

r. Whenever the author could confidently be identified, the Agency ha s chosen to show a personal author. When n o individual was identified, the Agency has shown a n identifiable laboratory or testing facility as the author. When n o author or laboratory could b e identified, the Agency has shown the first submitter as the author. b. Document date. The date of the study is taken directly from the document. When the date is followed by a question mark, the bibliographer has deduced the dat e from the evidence contained in the document. When the date appears as (19??), the Agency was unable to determine or estimate the date of the document.

c. Title. In some cases, it has been necessary for the A gency bibliographers to create or enhance a doc

ument title. Any such editorial insertions are contained between square brackets. d. Trailing parentheses. For stu dies submitted to the Agency in the past, the trailing parentheses include (in addition to any self-explanatory text) t he following elements describing the earliest known submission: (1) Sub

mission date. The date of the earliest known submission appear s immediately following the word "received." (2) Administrative number. The next element im mediately following the word "under " is the registration number, experimental use permit number,51 petition number, or other administrative number asso ciated with the earliest known submission. (3) Submitte

r. The third element is the submitter. When authorship i s defaulted to the submitter, this element is omitted. (4) Volume Identification (Accession Numbers). The final element in th e trailing par

entheses identifies the EPA accession number of the volume in which the original submission of the study appea rs. The six-digit accession num ber follows the symbol "CDL," which stands for "Company Dat a Lib rary." This accession number is in turn followed by an alphabeti c suffix which shows the relative position of the study within the volume.

### BIBLIOGRAPHY

MRID CITATION

______________________________________________________

52 --------- Beasom, S. L., (1982). Report on-Efficacy of the 1080 toxic collarsas a predator

damage control method (July 1, 1982 -September 30,1982). Texas A & M University, College Station, Texas.

--------- Burns R. J., Connolly, G. E. and Okuno, I. (1986). Second ary toxicity of coyotes killed by 1080 single-dose baits. Denver Wildlife Research Center, USDA/APHIS. Proc. 12th Vertebrate Pest Conf, San Diego, California. p324-329.

--------- Burns, R.J . and G.E. Connolly 1992. Toxicity of Compound 1080 to Magpie s and th e Relationship of Dose Rates to Residues Recovered. USDA, Denve r Wildlife Research Center. Proc. 15th Vertebr ate Pest Conf., Newport Beach, Ca. p403 (6).

--------- Dana, R. H. 1971. Vertebrate pest control in California . Unpublished mimeo. rep. California Dept. of Agriculture. 14 pp.

-------- Ghali, G. 1994. RfD/Peer Review Report of Sodium Fluoroacetate. U.S. EP A memorandum.

-------- Gribble, G. 1973. Fluoroacetate Toxicity. J. Chem. Educ. 50:460-2.

-------- Hegdal, P. L., T.A. Gatz, K. A. Fagerstone, J.F. Glahn and G. H.Matschke

. (1979 ). Hazards to wildlife associated with 1080 baiting for California groun d squirrels.

-------- Hilton, H. W., Q.H. Yuen, and N.S. Nomura. 1969. Absorption o f monofluoroacetate-2C ion and its transloca tion in sugarcane. J.Agric. Food Chem. 17:131-134.

-------- Hudson, R. K., R. K. Tucker, and M. A. Haegele, 1984. Handbook of toxicity

of pes ticides to wildlife, 2nd edition. U.S. Dept. ofInterior, Fish and Wildlif e Service, Resource Publication 153, Washington, D.C. 90 pp.

-------- Knowlton, F.F., and S.M. Ebbert. 1991. Develop physiologic markersto identify

co yotes that kill sheep or goats (Unpublished report to the EPA - QA-090 ) USDA/APHIS, Denver Wildlife Research Center,Denver, Colorado. 27 pp.

-------- Sax, N . I., and Lewis, R. J. SR, (1989) Dangerous Properties of Industria l Materials, 7th Ed. Van Nostrand Reinhold, NY.

-------- TAMUS (Texas A&M University System). 1983. Efficac y of the 1080 toxic collar as a predator damage control method. Final report tothe U.S. Fish and Wildlif e Serv ice for Cooperative Research Project No. 14-16-0009-81-934, September 1, 1980 -June 30, 1983. Department of Wildlife and Fisheries Sciences, Texa s Agric ulturalExperiment Station. Data report submitted to the Environmenta l Protection Agency to support mo dification of the Texas A&M University System, College Station, TX. 134 pp.

### BIBLIOGRAPHY

MRID CITATION

______________________________________________________

53 -------- USDA/AP HIS, 1986. Unpublished Report entitled: Residues of sodiu m fluoroacetate

(1080) in coyotes and on the necks of sheep due to the use of large (6 0 ml) compound 1080 livestock protection collars. Denver Wildlife Researc h Cent er, Denver, Colorado. A data report to support the registration of the 60 ml collar. Laboratory and Pen Studies. September 1985-January 1986. 10 pp.

-------- USDA/A PHIS, 1991. Correspondence from P. Joseph, summarizing th e information on the use of

the Compound 1080 Livestock Protection Collar during FY-1988, 1989, and 1990 in five western states.

-------- USFWS, 1984. Formal Section 7 Biological Opinion regarding 1 year extension

of experimental use permit for the 1080 toxi c collar in Idaho, Montana and Texas. (6704-EUP-14). (FWS/OES EPA-84-3) 5 pp.

-------- USF WS, 1985. Formal Section 7 Biological Opinion on the 1080 livestoc k protection collar. Region 6 (6-RO-85-001) 18 pp.

-------- USFWS, 1986. Letter from Allan J. Mueller , Acting Field Supervisor Division of Ecological Services, Houston, Texas to Roger Mulder, Regul atory Division, Texas Department of Agriculture, regarding endangered species use restrictions fo r Texas.

-------- Ward, J. C. and D.A. Spencer. 1947. Notes on the pharmacology ofsodiu m fluoroacetate-compound 1080. Journal of the American Pharmaceutica l Association. 36(2): 59-62.

-------- Wolfe, G. 1988. Subchronic Toxicity Study in Rats with Sodium Fluoroacetate.

Study No. HLA-2399-118. Unpublished study conducted by Hazleton.
00061746 At

zert, S.P. (1971) A Review of Sodium monofluoroacetate (Compound 1080) : Its Properties, Toxicology, and Use in Predator an d Rodent Control. By U.S. Fish and Wildlife Service, Div . of Wildlife Services. Washington, D.C.: U.S. FWS. (Spe cial scientific report--wildlife no. 146; available from: Superintendent o f Do cuments, U.S. Government Printing Office, Washington, D.C. 20402 ; published study; CDL:229637-B) 00061750 David, W.A.L.; Gardiner, B.O.C. (1966) Persistence of Fluoroacetate an d fluo roacetamide

in soil. Nature 209(5030):1367-1368. (Also in unpublishe d submission received A pr 21, 1977 under 35978-2; submitted by Wyoming, Dept. of Agriculture, cheyenne, Wyo.; CDL: 229637-F) 00065627 Connolly, G., comp. (1980) Use of Comp ound 1080 in Livestock Neck Collars to Kill Depredating Coyotes. (U.S. Fish and Wildlife Service, Denver Wildlif e Research Center; unpublished study including published data; CDL:243665-A)

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ns, R.; Connolly, G.; Meeker, D.; et al. (1984) Efficacy and Hazards o f Compound

1080 in Toxic Collars: Laboratory and Pen Studies, April 1980 Jul y 1984. U npublished compilation prepared by US Fish and Wildlife Service , Denver Wildlife Research Center. 53 p. 00243665 USDI Fish and Wildlife. 1980. Acute Oral Toxicity Study with Coyotes. 40016958 Goldman, P.; Milne, G. (1966) Ca rbon-fluorine bond cleavage. II. Studies on the mechanism of the defluorination of fluoroacetate. Journal of Biological Chemistry 241(23):5557-5559. 40016959 Harrison, B.; Bransford, A.; MaNamara, B. (1951) Deterioration of sodiu m monofluoroacetate in water and saline solutions. Federation Proceed. Pharm. and Experimental Therapeutics 10:306-307. 40016963 Ke

lly, M. (1965) Isolation of bacteria able to metabolize fluoroacetate o r fluoroacetamide. Nature 208(5012):809-810. 40016964 Lien, B.; Cole, A.; Walker, J. (1979 ) Effect of sodium fluoroacetate ("compound 1080") on the soil microflora. Soil Biol. Biochem. 11:13-18. 40016965 Tonomura , K.; Futai, F.; Tanabe, O., et al. (1965) Defluorination o f monofl uoroacetate

by bacteria. Part I. Isolation of bacteria and their activity o f defluorination. Agr. Biol. Chem. 29(2): 124-128. 40016966 Walker, J.; Lien, B. (1981) Metabolism of fluoroacetate by a soil Pseudomonas

sp. and Fusarium solani. Soil. Biol. Biochem. 13: 231-235. 40016967 Corr, P.; Martire, P. (1971) Leaching by rain of sodium fluoroacetate ("1080")

from baits used for rabbit control. Austral. J. Exp. Agric. and Animal Husb

. 11(Jun):287-281. 40016969 Pete

rs, J. (1974) Environmental Contamination, Toxicology, and Residues o f Compound 1080 (Sodium Fluoroacetate) in Relation to Aerial Co ntrol Programmes in Protection Forests: A Synopsis. Unpublished study prepared by New Zealand Forest Service. 6 p. 40016970 Stapl es, E. (1968) The reduction of the sodium monofluoroacetate ("1080" )

content of carrot baits of various thickness by weathering. N.Z. Jour. Agric. Res. 11(2):319-329. 40016971 Dieke, S.; Richter, C. (1946) Comparative assays of rodenticides on wild norway

rats: I. Toxicity. Reprint No. 2708, Public Health Reports 61(19):672-679. 40016990 Sullivan, J.; Smith, F.; Garman, R. (1979) Effects of fluoroacetate on the testis

of the rat. Reprod. Fert. 56:201-207.

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55 40402603 Cerven, D. (1987) Primary Eye Irritation/Corrosion in Albino Rabbits: Sodiu m Monofluoroacet

ate Compound 1080-1% (...) Poison: Lab. Proj. ID MB 87-8886 D. Unpublished study prepared by MB Research Laboratories, Inc. 11 p. 40402604 Cerve

n, D. (1987) Primary Dermal Irritation in Albino Rabbits: Sodiu m Monofluoroacet

ate Compound 1080-1% (...) Poison: Lab. Proj. ID MB 87-8886 C. Unpublished study prepared by MB Research Laboratories, Inc. 10 p. 41514901 Savar

ie, P.; Burns, R.; Zemlicka, D. (1990) Sodium Fluoroacetate (Compoun d 1080) C ontamination on the Necks of Lambs with Livestock Protection Collar s (LPCs) that are killed by Coyotes: Lab Project Number: QA-65. Unpublishe d study prepared by USDA-AP HIS-S&T, Denver Wildlife Research Center. 227 p. 42961601 Col lins, M. (1993) Sodium Fluoroacetate-Acute Toxicity to Bluegill Sunfis h (Lepomis macrochirus) Under Static Renewal Conditions: Lab Project Number : 13014.0293.6100.100: DWR C QA-294: 93-7-4847. Unpublished study prepared by Springborn Labs, Inc. 65 p. 42961602 Coll ins, M. (1993) Sodium Fluoroacetate-Acute Toxicity to Rainbow Trou t (O ncorhynchus

mykiss) Under Static Conditions: Lab Project Number : 13 014.0293.6101.103: QA-295: 93-8-4885. Unpublished study prepared b y Springborn Labs, Inc. 68 p. 42961603 Collins, M. (1993) Sodium Fluoroacetate-Acute Toxicity to Daphnids (Daphni a

magna) Under Static Conditions: Lab Project Number: 13014.0293.6102.110 : DWRC QA-296: 93-7-4844. Unpublished study prepared by Springb orn Labs, Inc. 70 p. 43210601 Cam

pbell, S.; Beavers, J.; Grimes, J. (1994) Sodium Fluoroacetate: A Dietar y LC50 Study with the Northern Bobwhite: Lab Project Number: 247-101B : QA-297: 94-021. Unpublished study prepared by Wildlife International Ltd. 27 p. 43210602 Cam

pbell, S.; Beavers, J.; Grimes, J. (1994) Sodium Fluoroacetate: A Dietar y LC50 Study with the Mall ard: Lab Project Number: 247-102B: 94-021: QA-298. Unpublished study prepared by Wildlife International Ltd. 26 p.56 **APPENDIX D.**  **Product Specific Data Call-In** UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES DATA CALL-IN NOTICE
CERTIFIED MAIL

Dear Sir or Madam: This Notice requires you and other registrants of pesticide products containing the active ingredient identified in Attachment 1 of this Notice, the Data Call-In Chemical Status Sheet , to submit certain product specific data as noted herein to the U.S. Environmental Protection Agency (EPA, the Agency). These data are necessary to maintain the continued registration of your product(s) containing this active ingredient. Within 90 days after you receive this Notice you must respond as set forth in Section III below. Your response must state: 1. How you will comply with the requirements set forth in this Notice and its Attachments A through G; or 2. Why you believe you are exempt from the requirements listed in this Notice and in Attachment 3, Requirements Status and Registrant's Response Form , (see section III-B); or 3. Why you believe EPA should not require your submission of product specific data in the manner specified by this Notice (see section III-D). If you do not respond to this Notice, or if you do not satisfy EPA that you will comply with its requirements or should be exempt or excused from doing so, then the registration of your product(s) subject to this Notice will be subject to suspension. We have provided a list of all of your products subject to this Notice in Attachment 2, Data Call-In Response Form , as well as a list of all registrants who were sent this Notice (Attachment 6). The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070- 0107 (expiration date 12-31-92). This Notice is divided into six sections and seven Attachments. The Notice itself contains information and instructions applicable to all Data Call-In Notices. The Attachments contain specific chemical information and instructions. The six sections of the Notice are: Section I - Why You Are Receiving This Notice Section II - Data Required By This Notice57

Section III - Compliance With Requirements Of This Notice Section IV - Consequences Of Failure To Comply With This Notice Section V - Registrants' Obligation To Report Possible Unreasonable

Adverse Effects Section VI - Inquiries And Responses To This Notice The Attachments to this Notice are: 1 - Data Call-In Chemical Status Sheet 2 - Product-Specific Data Call-In Response Form 3 - Requirements Status and Registrant's Response Form 4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data Requirements for Reregistration 5 - List of Registrants Receiving This Notice 6 - Cost Share and Data Compensation Forms, and Product Specific Data Report Form
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE The Agency has reviewed existing data for this active ingredient and reevaluated the data needed to support continued registration of the subject active ingredient. The Agency has concluded that the only additional data necessary are product specific data. No additional generic data requirements are being imposed. You have been sent this Notice because you have product(s) containing the subject active ingredient. SECTION II. DATA REQUIRED BY THIS NOTICE II-A. DATA REQUIRED The product specific data required by this Notice are specified in Attachment 3, Requirements Status and Registrant's Response Form . Depending on the results of the studies required in this Notice, additional testing may be required. II-B. SCHEDULE FOR SUBMISSION OF DATA You are required to submit the data or otherwise satisfy the data requirements specified in Attachment 3, Requirements Status and Registrant's Response Form , within the time frames provided. II-C. TESTING PROTOCOL All studies required under this Notice must be conducted in accordance with test standards outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been established. These EPA Guidelines are available from the National Technical Information Service (NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650). Protocols approved by the Organization for Economic Cooperation and Development (OECD) are also acceptable if the OECD-recommended test standards conform to those specified in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the OECD protocols, they should be modified as appropriate so that the data generated by the study will satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend58

deadlines for complying with data requirements when the studies were not conducted in accordance with acceptable standards. The OECD protocols are available from OECD, 1750 Pennsylvania Avenue N.W., Washington, D.C. 20006. All new studies and proposed protocols submitted in response to this Data Call-In Notice must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)]. II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES ISSUED BY THE AGENCY Unless otherwise noted herein, this Data Call-In does not in any way supersede or change the requirements of any previous Data Call-In(s) , or any other agreements entered into with the Agency pertaining to such prior Notice. Registrants must comply with the requirements of all Notices to avoid issuance of a Notice of Intent to Suspend their affected products. SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE III-A. SCHEDULE FOR RESPONDING TO THE AGENCY The appropriate responses initially required by this Notice for product specific data must be submitted to the Agency within 90 days after your receipt of this Notice. Failure to adequately respond to this Notice within 90 days of your receipt will be a basis for issuing a Notice of Intent to Suspend (NOIS) affecting your products. This and other bases for issuance of NOIS due to failure to comply with this Notice are presented in Section IV-A and IV-B. III-B. OPTIONS FOR RESPONDING TO THE AGENCY The options for responding to this Notice for product specific data are: (a) voluntary cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice or (c) request a data waiver(s). A discussion of how to respond if you chose the Voluntary Cancellation option is presented below. A discussion of the various options available for satisfying the product specific data requirements of this Notice is contained in Section III-C. A discussion of options relating to requests for data waivers is contained in Section III-D. There are two forms that accompany this Notice of which, depending upon your response, one or both must be used in your response to the Agency. These forms are the Data-Call-In Response Form , and the Requirements Status and Registrant's Response Form , Attachment 2 and Attachment 3. The Data Call-In Response Form must be submitted as part of every response to this Notice. In addition, one copy of the Requirements Status and Registrant's Response Form must be submitted for each product listed on the Data Call-In Response Form

unless the voluntary cancellation option is selected or unless the product is identical to another (refer to the instructions for completing the Data Call-In Response Form in Attachment 2). Please note that the company's authorized representative is required to sign the first page of the Data Call-In Response Form and Requirements Status and Registrant's Response Form

(if this form is required) and initial any subsequent pages. The forms contain separate detailed instructions on the response options. Do not alter the printed material. If you have questions or need assistance in preparing your response, call or write the contact person(s) identified in Attachment 1. 1. Voluntary Cancellation - You may avoid the requirements of this Notice by requesting voluntary cancellation of your product(s) containing the active ingredient that is the subject of this Notice. If you wish to voluntarily cancel your product, you must submit a59

completed Data Call-In Response Form , indicating your election of this option. Voluntary cancellation is item number 5 on the Data Call-In Response Form . If you choose this option, this is the only form that you are required to complete. If you chose to voluntarily cancel your product, further sale and distribution of your product after the effective date of cancellation must be in accordance with the Existing Stocks provisions of this Notice which are contained in Section IV-C. 2. Satisfying the Product Specific Data Requirements of this Notice There are various options available to satisfy the product specific data requirements of this Notice. These options are discussed in Section III-C of this Notice and comprise options 1 through 6 on the Requirements Status and Registrant's Response Form and item numbers 7a and 7b on the Data Call-In Response Form

. Deletion of a use(s) and the low volume/minor use option are not valid options for fulfilling product specific data requirements. 3. Request for Product Specific Data Waivers . Waivers for product specific data are discussed in Section III-D of this Notice and are covered by option 7 on the Requirements Status and Registrant's Response Form . If you choose one of these options, you must submit both forms as well as any other information/data pertaining to the option chosen to address the data requirement. III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE If you acknowledge on the Data Call-In Response Form that you agree to satisfy the product specific data requirements (i.e. you select item number 7a or 7b), then you must select one of the six options on the Requirements Status and Registrant's Response Form related to data production for each data requirement. Your option selection should be entered under item number 9, "Registrant Response." The six options related to data production are the first six options discussed under item 9 in the instructions for completing the Requirements Status and Registrant's Response Form . These six options are listed immediately below with information in parentheses to guide registrants to additional instructions provided in this Section. The options are: (1) I will generate and submit data within the specified time frame (Developing Data) (2) I have entered into an agreement with one or more registrants to develop data jointly (Cost Sharing) (3) I have made offers to cost-share (Offers to Cost Share) (4) I am submitting an existing study that has not been submitted previously to the Agency by anyone (Submitting an Existing Study) (5) I am submitting or citing data to upgrade a study classified by EPA as partially acceptable and upgradeable (Upgrading a Study) (6) I am citing an existing study that EPA has classified as acceptable or an existing study that has been submitted but not reviewed by the Agency (Citing an Existing Study) Option 1, Developing Data -- If you choose to develop the required data it must be in conformance with Agency deadlines and with other Agency requirements as referenced herein and in the attachments. All data generated and submitted must comply with the Good Laboratory Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide Assessment Guidelines (PAG), and be in conformance with the requirements of PR Notice 86- 5.60

The time frames in the Requirements Status and Registrant's Response Form are the time frames that the Agency is allowing for the submission of completed study reports. The noted deadlines run from the date of the receipt of this Notice by the registrant. If the data are not submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to Suspend the affected registration(s). If you cannot submit the data/reports to the Agency in the time required by this Notice and intend to seek additional time to meet the requirements(s), you must submit a request to the Agency which includes: (1) a detailed description of the expected difficulty and (2) a proposed schedule including alternative dates for meeting such requirements on a step-by-step basis. You must explain any technical or laboratory difficulties and provide documentation from the laboratory performing the testing. While EPA is considering your request, the original deadline remains. The Agency will respond to your request in writing. If EPA does not grant your request, the original deadline remains. Normally, extensions can be requested only in cases of extraordinary testing problems beyond the expectation or control of the registrant. Extensions will not be given in submitting the 90-day responses. Extensions will not be considered if the request for extension is not made in a timely fashion; in no event shall an extension request be considered if it is submitted at or after the lapse of the subject deadline. Option 2, Agreement to Share in Cost to Develop Data -- Registrants may only choose this option for acute toxicity data and certain efficacy data and only if EPA has indicated in the attached data tables that your product and at least one other product are similar for purposes of depending on the same data. If this is the case, data may be generated for just one of the products in the group. The registration number of the product for which data will be submitted must

be noted in the agreement to cost share by the registrant selecting this option. If you choose to enter into an agreement to share in the cost of producing the required data but will not be submitting the data yourself, you must provide the name of the registrant who will be submitting the data. You must also provide EPA with documentary evidence that an agreement has been formed. Such evidence may be your letter offering to join in an agreement and the other registrant's acceptance of your offer, or a written statement by the parties that an agreement exists. The agreement to produce the data need not specify all of the terms of the final arrangement between the parties or the mechanism to resolve the terms. Section 3(c)(2)(B) provides that if the parties cannot resolve the terms of the agreement they may resolve their differences through binding arbitration. Option 3, Offer to Share in the Cost of Data Development -- This option only applies to acute toxicity and certain efficacy data as described in option 2 above. If you have made an offer to pay in an attempt to enter into an agreement or amend an existing agreement to meet the requirements of this Notice and have been unsuccessful, you may request EPA (by selecting this option) to exercise its discretion not to suspend your registration(s), although you do not comply with the data submission requirements of this Notice. EPA has determined that as a general policy, absent other relevant considerations, it will not suspend the registration of a product of a registrant who has in good faith sought and continues to seek to enter into a joint data development/cost sharing program, but the other registrant(s) developing the data has refused to accept your offer. To qualify for this option, you must submit documentation to the Agency proving that you have made an offer to another registrant (who has an obligation to submit data) to share in the burden of developing that data. You must also submit to the Agency a completed EPA Form 8570-32, Certification of Offer to Cost Share in the Development of Data, Attachment 7. In addition, you must demonstrate that the other registrant to whom the offer was made has not accepted your offer to enter into a cost sharing agreement by including a copy of your offer and proof of the other registrant's receipt of that offer (such as a certified mail receipt). Your offer must, in addition to anything else, offer to share in the burden of producing the data upon terms to be agreed or failing agreement to be61

bound by binding arbitration as provided by FIFRA section 3(c)(2)(B)(iii) and must not qualify this offer. The other registrant must also inform EPA of its election of an option to develop and submit the data required by this Notice by submitting a Data Call-In Response Form and a Requirements Status and Registrant's Response Form committing to develop and submit the data required by this Notice. In order for you to avoid suspension under this option, you may not withdraw your offer to share in the burdens of developing the data. In addition, the other registrant must fulfill its commitment to develop and submit the data as required by this Notice. If the other registrant fails to develop the data or for some other reason is subject to suspension, your registration as well as that of the other registrant will normally be subject to initiation of suspension proceedings, unless you commit to submit, and do submit the required data in the specified time frame. In such cases, the Agency generally will not grant a time extension for submitting the data. Option 4, Submitting an Existing Study -- If you choose to submit an existing study in response to this Notice, you must determine that the study satisfies the requirements imposed by this Notice. You may only submit a study that has not been previously submitted to the Agency or previously cited by anyone. Existing studies are studies which predate issuance of this Notice. Do not use this option if you are submitting data to upgrade a study. (See Option 5). You should be aware that if the Agency determines that the study is not acceptable, the Agency will require you to comply with this Notice, normally without an extension of the required date of submission. The Agency may determine at any time that a study is not valid and needs to be repeated. To meet the requirements of the DCI Notice for submitting an existing study, all of the following three criteria must be clearly met :
a. You must certify at the time that the existing study is submitted that the raw data and specimens from the study are available for audit and review and you must identify where they are available. This must be done in accordance with the requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR Part 160. As stated in 40 CFR 160.3(j) " 'raw data' means any laboratory worksheets, records, memoranda, notes, or exact copies thereof, that are the result of original observations and activities of a study and are necessary for the reconstruction and evaluation of the report of that study. In the event that exact transcripts of raw data have been prepared (e.g., tapes which have been transcribed verbatim, dated, and verified accurate by signature), the exact copy or exact transcript may be substituted for the original source as raw data. 'Raw data' may include photographs, microfilm or microfiche copies, computer printouts, magnetic media, including dictated observations, and recorded data from automated instruments." The term "specimens", according to 40 CFR 160.3(k), means "any material derived from a test system for examination or analysis." b. Health and safety studies completed after May 1984 must also contain all GLPrequired quality assurance and quality control information, pursuant to the requirements of 40 CFR Part 160. Registrants must also certify at the time ofsubmitting the existing study that such GLP information is available for postMay 1984 studies by including an appropriate statement on or attached to the study signed by an authorized official or representative of the registrant.62

c. You must certify that each study fulfills the acceptance criteria for the Guideline relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3 Technical Guidance and that the study has been conducted according to the Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG (both available from NTIS). A study not conducted according to the PAG may be submitted to the Agency for consideration if the registrant believes that the study clearly meets the purpose of the PAG. The registrant is referred to 40 CFR 158.70 which states the Agency's policy regarding acceptable protocols. If you wish to submit the study, you must, in addition to certifying that the purposes of the PAG are met by the study, clearly articulate the rationale why you believe the study meets the purpose of the PAG, including copies of any supporting information or data. It has been the Agency's experience that studies completed prior to January 1970 rarely satisfied the purpose of the PAG and that necessary raw data are usually not available for such studies. If you submit an existing study, you must certify that the study meets all requirements of the criteria outlined above. If you know of a study pertaining to any requirement in this Notice which does not meet the criteria outlined above but does contain factual information regarding unreasonable adverse effects, you must notify the Agency of such a study. If such study is in the Agency's files, you need only cite it along with the notification. If not in the Agency's files, you must submit a summary and copies as required by PR Notice 86-5. Option 5, Upgrading a Study -- If a study has been classified as partially acceptable and upgradeable, you may submit data to upgrade that study. The Agency will review the data submitted and determine if the requirement is satisfied. If the Agency decides the requirement is not satisfied, you may still be required to submit new data normally without any time extension. Deficient, but upgradeable studies will normally be classified as supplemental. However, it is important to note that not all studies classified as supplemental are upgradeable. If you have questions regarding the classification of a study or whether a study may be upgraded, call or write the contact person listed in Attachment 1. If you submit data to upgrade an existing study you must satisfy or supply information to correct all deficiencies in the study identified by EPA. You must provide a clearly articulated rationale of how the deficiencies have been remedied or corrected and why the study should be rated as acceptable to EPA. Your submission must also specify the MRID number(s) of the study which you are attempting to upgrade and must be in conformance with PR Notice 86-5. Do not submit additional data for the purpose of upgrading a study classified as unacceptable and determined by the Agency as not capable of being upgraded. This option should also be used to cite data that has been previously submitted to upgrade a study, but has not yet been reviewed by the Agency. You must provide the MRID number of the data submission as well as the MRID number of the study being upgraded. The criteria for submitting an existing study, as specified in Option 4 above, apply to all data submissions intended to upgrade studies. Additionally your submission of data intended to upgrade studies must be accompanied by a certification that you comply with each of those criteria as well as a certification regarding protocol compliance with Agency requirements. Option 6, Citing Existing Studies -- If you choose to cite a study that has been previously submitted to EPA, that study must have been previously classified by EPA as acceptable or it must be a study which has not yet been reviewed by the Agency. Acceptable63

toxicology studies generally will have been classified as "core-guideline" or "core minimum." For all other disciplines the classification would be "acceptable." With respect to any studies for which you wish to select this option you must provide the MRID number of the study you are citing and, if the study has been reviewed by the Agency, you must provide the Agency's classification of the study. If you are citing a study of which you are not the original data submitter, you must submit a completed copy of EPA Form 8570-31, Certification with Respect to Data Compensation Requirements

. Registrants who select one of the above 6 options must meet all of the requirements described in the instructions for completing the Data Call-In Response Form and the Requirements Status and Registrant's Response Form, as appropriate. III-D REQUESTS FOR DATA WAIVERS

If you request a waiver for product specific data because you believe it is inappropriate, you must attach a complete justification for the request, including technical reasons, data and references to relevant EPA regulations, guidelines or policies. (Note: any supplemental data must be submitted in the format required by PR Notice 86-5). This will be the only opportunity to state the reasons or provide information in support of your request. If the Agency approves your waiver request, you will not be required to supply the data pursuant to section 3(c)(2)(B) of FIFRA. If the Agency denies your waiver request, you must choose an option for meeting the data requirements of this Notice within 30 days of the receipt of the Agency's decision. You must indicate and submit the option chosen on the Requirements Status and Registrant's Response Form . Product specific data requirements for product chemistry, acute toxicity and efficacy (where appropriate) are required for all products and the Agency would grant a waiver only under extraordinary circumstances. You should also be aware that submitting a waiver request will not automatically extend the due date for the study in question. Waiver requests submitted without adequate supporting rationale will be denied and the original due date will remain in force. IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE IV-A NOTICE OF INTENT TO SUSPEND The Agency may issue a Notice of Intent to Suspend products subject to this Notice due to failure by a registrant to comply with the requirements of this Data Call-In Notice, pursuant to FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent to Suspend include, but are not limited to, the following: 1. Failure to respond as required by this Notice within 90 days of your receipt of this Notice. 2. Failure to submit on the required schedule an acceptable proposed or final protocol when such is required to be submitted to the Agency for review. 3. Failure to submit on the required schedule an adequate progress report on a study as required by this Notice. 4. Failure to submit on the required schedule acceptable data as required by this Notice.64

5. Failure to take a required action or submit adequate information pertaining to any option chosen to address the data requirements (e.g., any required action or information pertaining to submission or citation of existing studies or offers, arrangements, or arbitration on the sharing of costs or the formation of Task Forces, failure to comply with the terms of an agreement or arbitration concerning joint data development or failure to comply with any terms of a data waiver). 6. Failure to submit supportable certifications as to the conditions of submitted studies, as required by Section III-C of this Notice. 7. Withdrawal of an offer to share in the cost of developing required data. 8. Failure of the registrant to whom you have tendered an offer to share in the cost of developing data and provided proof of the registrant's receipt of such offer or failure of a registrant on whom you rely for a generic data exemption either to:
a. inform EPA of intent to develop and submit the data required by this Notice on a Data Call-In Response Form and a Requirements Status and Registrant's Response Form; b. fulfill the commitment to develop and submit the data as required by this Notice; or

c. otherwise take appropriate steps to meet the requirements stated in this Notice, unless you commit to submit and do submit the required data in the specified time frame. 9. Failure to take any required or appropriate steps, not mentioned above, at any time following the issuance of this Notice. IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS UNACCEPTABLE The Agency may determine that a study (even if submitted within the required time) is unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds for suspension include, but are not limited to, failure to meet any of the following: 1. EPA requirements specified in the Data Call-In Notice or other documents incorporated by reference (including, as applicable, EPA Pesticide Assessment Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test Guidelines) regarding the design, conduct, and reporting of required studies. Such requirements include, but are not limited to, those relating to test material, test procedures, selection of species, number of animals, sex and distribution of animals, dose and effect levels to be tested or attained, duration of test, and, as applicable, Good Laboratory Practices. 2. EPA requirements regarding the submission of protocols, including the incorporation of any changes required by the Agency following review. 3. EPA requirements regarding the reporting of data, including the manner of reporting, the completeness of results, and the adequacy of any required supporting (or raw) data, including, but not limited to, requirements referenced or included in this Notice or contained in PR 86-5. All studies must be submitted in the form of a final65

report; a preliminary report will not be considered to fulfill the submission requirement. IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS EPA has statutory authority to permit continued sale, distribution and use of existing stocks of a pesticide product which has been suspended or cancelled if doing so would be consistent with the purposes of the Act. The Agency has determined that such disposition by registrants of existing stocks for a suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not be consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants permission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional circumstances. If you believe such disposition of existing stocks of your product(s) which may be suspended for failure to comply with this Notice should be permitted, you have the burden of clearly demonstrating to EPA that granting such permission would be consistent with the Act. You must also explain why an "existing stocks" provision is necessary, including a statement of the quantity of existing stocks and your estimate of the time required for their sale, distribution, and use. Unless you meet this burden the Agency will not consider any request pertaining to the continued sale, distribution, or use of your existing stocks after suspension. If you request a voluntary cancellation of your product(s) as a response to this Notice and your product is in full compliance with all Agency requirements, you will have, under most circumstances, one year from the date your 90 day response to this Notice is due, to sell, distribute, or use existing stocks. Normally, the Agency will allow persons other than the registrant such as independent distributors, retailers and end users to sell, distribute or use such existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of voluntarily cancelled products containing an active ingredient for which the Agency has particular risk concerns will be determined on case-by-case basis. Requests for voluntary cancellation received after the 90 day response period required by this Notice will not result in the Agency granting any additional time to sell, distribute, or use existing stocks beyond a year from the date the 90 day response was due unless you demonstrate to the Agency that you are in full compliance with all Agency requirements, including the requirements of this Notice. For example, if you decide to voluntarily cancel your registration six months before a 3 year study is scheduled to be submitted, all progress reports and other information necessary to establish that you have been conducting the study in an acceptable and good faith manner must have been submitted to the Agency, before EPA will consider granting an existing stocks provision. SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE UNREASONABLE

ADVERSE EFFECTS Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a pesticide is registered a registrant has additional factual information regarding unreasonable adverse effects on the environment by the pesticide, the registrant shall submit the information to the Agency. Registrants must notify the Agency of any factual information they have, from whatever source, including but not limited to interim or preliminary results of studies, regarding unreasonable adverse effects on man or the environment. This requirement continues as long as the products are registered by the Agency. SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE66

If you have any questions regarding the requirements and procedures established by this Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status Sheet

. All responses to this Notice (other than voluntary cancellation requests and generic data exemption claims) must include a completed Data Call-In Response Form and a completed Requirements Status and Registrant's Response Form (Attachment 2 and Attachment 3 for product specific data) and any other documents required by this Notice, and should be submitted to the contact person(s) identified in Attachment 1. If the voluntary cancellation or generic data exemption option is chosen, only the Data Call-In Response Form need be submitted. The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic Substances (OPTS), EPA, will be monitoring the data being generated in response to this Notice. Sincerely yours,

Lois Rossi, Division Director Special Review and Reregistration Division Attachments 1 - Data Call-In Chemical Status Sheet 2 - Product-Specific Data Call-In Response Form 3 - Requirements Status and Registrant's Response Form 4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data Requirements for Reregistration 5 - List of Registrants Receiving This Notice 6 - Cost Share and Data Compensation Forms, and Product Specific Data Report Form67

**Attachment 1.**  **Chemical Status Sheets SODIUM FLUOROACETATE DATA CALL-IN CHEMICAL STATUS SHEET**  INTRODUCTION You have been sent this Generic Data Call-In Notice because you have product(s ) containing sodium fluoroacetate. This Generic Data Call-In Chemical Status Sheet , contains an overview of data required by th is notice, and point of contact for inquiries pertaining to the reregistration of SODIU M FLUOROACETATE

. This attachment is to be used in conjunction with (1) the Generic Dat a Call-In Notice, (2) the Generic Data Call-In Response Form (Attachme nt 2), (3) the Requirements Status and Registrant's Form (Attachment 2), (4) a list of registrants receiving this DC I (Attachment 4), (5) the EPA Acceptance Criteria (Attachment 5), an d (6) the Cost Share and Data Compensatio

n Forms in replying to this sodium fluoroacetate Generic Data Call In (Attachment F). Instructions and guidance accompany each form. DATA REQUIRED BY THIS NOTICE The additional data requirements needed to complete the generic database for sodiu m fluoroacetate are contained in the Requir ements Status and Registrant's Response , Attachment C. The Ag ency has concluded that additional product chemistry data on sodium fluoroacetate ar e needed. These data are needed to fully complete the reregistration of all eligible sodiu m fluoroacetate products. INQUIRIES AND RESPONSES TO THIS NOTICE If you have any questions regarding the generic data requirements and procedure s established by this Notice, please contact Leonard Ryan at (703) 308-8067. All responses to this Notice for the generic data requirements should be submitted to: Leonard Ryan, Chemical Review Manager Accelerated Reregistration Branch Special Review and Registration Division (H7508W) Office of Pesticide Programs U.S. Environmental Protection Agency Washington, D.C. 20460 RE: SODIUM FLUOROACETATE68

**Attachment 2.**  **Product Specific Data Call-In Response Forms (Form A inserts) Plus**  **Instructions** INSTRUCTIONS FOR COMPLETING THE **DATA CALL-IN RESPONSE FORM** FOR **PRODUCT SPECIFIC DATA** Item 1-4. Already completed by EPA. Item 5. If you wish to **voluntarily ca ncel**  your product, answer " **yes** ." If you choose this option, you will not have to provide the data required by the Data Call-In Notice and you will n

ot have to complete any other forms. Further sale and distribution of your product after the effe ctive date of cancellation must be in accordance with the Existing Stocks provision of the Data Call-In Notice (Section IV-C). Item 6. Not

applica ble since this form calls in product specific data only. However, i f your product is **identical**

to another product and you qualify for a **data exemption**

, you must respond with " **yes** " to Item 7a (MUP) or 7B (EUP) o n this form, provide the **EPA r egistration numbers of your source(s)**  ; you would **not** complete th

e "Require ments Status and Registrant's Response" form. Examples of suc h prod ucts include **repackaged**

products and **Special Local Needs (Section 24c )**  products which are identical to federally registered products. Item 7a. For each **manufacturing use product** (MUP) for which you wish to maintai n registration, you must agre e to satisfy the data requirements by responding " **yes** ."
Item 7b. For each **end use product** (EUP) for which you wish to maintain registration, you must agree to satisfy the data requirements by responding " **yes** ." If you ar

e requesting

a **data waiver** , answer " **yes** " here; in addition, on the "Requirements Status and Registrant's Response" form under Item 9, you must respond wit h **Option 7** (Waiver Request) for ea

ch study for which you are requesting a waiver. See Item 6 with regard to identical products and data exemptions. Items 8-11. Self-explanatory. **NOTE** : You may provide **additional information** that does no

t fit on this form in a signed letter that accompanies this form . For example, you may wish to report that your product has already been tra nsferred to another company or that you have already voluntarily canceled this product. For these cases, please supply all relevan t details so that EPA can ensure that its records are correct.69

INSTRUCTIONS FOR COMPLETING THE **REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE FORM**  FOR **PRODUCT SPECIFIC DATA** Item 1-3 Completed by EPA. Note the **unique identifier number** a ssigned by EPA in Item 3. This num

ber **must be used in the transmittal document for any dat a**  **submissions**

in response to this Data Call-In Notice. Item 4. The

gui deline reference numbers of studies required to support the product' s cont inued registration are identified. These guidelines, in addition to th e requirements specified in the Notice, govern the conduct of the required studies. Note that s eries 61 and 62 in product chemistry are now listed under 40 CF R 158.155 through 158.180, Subpart C. Item 5. The study title associated with the guideline reference number is identified. Item 6. The use pattern(s) of the pesticide associated with the product specific requirements is (are) identified. For most product specific data requirements, all use patterns are covered by the data requirements. In the case of efficacy data, the require d studies only pertain to products which have the use sites and/or pests indicated. Item 7. The substance to be tested is identified by EPA. For product specific data, th e product as formulated for sale and distribution is the test substance, except in rare cases. Item 8. The

due date for submission of each study is identified. It is normally based on **8 months after issuance of the Rereg istration Eligibility Document**  unless EPA determines that a longer time period is necessary. Item 9. **Enter only one**  **of the following response codes**  **for each data requirement to**  **show how you intend to comply with the data requirement s listed in this table.**  Fuller descriptions of each option are contained in the Data Call-In Notice. 1. I will genera

te and submit data by the specified due date ( **Developing Data** ). By indicating that I have chosen this option, I certify that I will comply with all the requirements pertaini ng to the conditions for submittal of this study as outlined in the Da ta Call-In Notice. By the specified due date, I will also submit: (1) a completed **"Certification Wit h Respect To Data Compensation Requirements"**  **form (EPA Form 8570-29)**  and (2) two completed and signed copies of th e **Confidential Statement of Formula (EPA Form 8570-4)**

. 2. I have

entered into an agreement with one or more registrants to develop dat a jointly ( **Cost Sharing**

). I am submitting a **copy of this agreement** . I understand that this option is available **only** for acute toxi city or certain efficacy data and **only** if EPA indicates in an attachm ent to this Notice that my product is similar enough to anoth er product to qualify for this option. I certify that another party in th e agr eement is committing to submit or provide the required data; if the require d study is not submitted on time, my product may be subject to suspension. By the specified due date, I will also submit: (1) a completed **"Certification Wit h**  **Respect To Data Compensation Requirements" f orm (EPA Form 8570-29)**  and (2) tw o completed and signed copies of the **Confidential Statement of Formula (EPA Form 8570-4)** 

. 3. I have made o

ffers to share in the cost to develop data ( **Offers to Cost Share** )

. I understand that this op

tion is available **only**

for acute toxicity or certain efficacy70 data and **only**

if EPA indicates in an attachment to thi s Data Call-In Notice that my product is similar enough to another product to qualify for this option. I a m submitting **evidence tha**

**t I have made an offer** to another registrant (who has an obligation to submit

data) to share in the cost of that data. I am also submitting a com pleted **"Certification of Offer to Cost Share in the Development Data "**  **form** . I am including a copy of my offer and proof of the other registrant's receipt of that offer. I am identifying the party which is committing to submit or provide the required data; if the required study is not submitted on time, my product may be subject to suspension. I understand tha t other terms under Option 3 in the Data C a ll-In Notice (Section III-C.1.) apply as well. By the specified due date, I will also submit: (1) a completed **"Certification With Respect To Data Compensation**  **Req uirements"**  **form (EPA Form 8570-29)** and (2) two completed and signe d copies of the **Confidential Statement of Formula (EPA Form 8570-4)**

. 4. By the specified due date, I will submit an existing study that has not bee n submi tted previously to the Agency by anyone ( **Submitting an Existing Study** ). I certify that this study will meet all the re quirements for submittal of existing data outlined in Option 4 in the Data Call-In Notice (Se ction III-C.1.) and will meet the attached acceptance criteria (for acute toxicity and product chemistry data). I will a t tach the needed supporting information along with this response. I also certify that I have determined that this study will fill the data requir ement for which I have indicated thi s choice. By the specified due date, I will also submit a complete d **"Certification With Respect To Data Compensation Requiremen ts" form (EPA**  **Form 8570-29**  **)** to show what data compensation option I have chosen. By th e specified due date, I will also submit: (1) a completed **"Certification Wit h**  **Respect To Data Compensation Requirements" f orm (EPA Form 8570-29)**  and (2) tw o completed and signed copies of the **Confidential Statement of Formula (EPA Form 8570-4)** 

. 5. By

the specified due date, I will submit or cite data to upgrade a study classified by the Agency as partially acceptable and upgradable ( **U pgrading a Study**  ). I will submit **evidence of the Agency's review** indicating that the study may be upgraded and what information is requ ired to do so. I will provide the MRID or Accession number of the study at the due date. I understand that the conditions for thi s op tion outlined Option 5 in the Data Call-In Notice (Section III-C.1.) apply. By the specif ied due date, I will also submit: (1) a completed **"Certification Wit h**  **Respect To Data Compensation Requirements" f orm (EPA Form 8570-29)**  and (2) tw o completed and signed copies of the **Confidential Statement of Formula (EPA Form 8570-4)** 

. 6. By

the specified due date, I will cite an existing study that the Agency ha s classi fied as acceptable or an existing study that has been submitted but no t reviewed by the Agency ( **Citing an Existing Study** ). If I am citing anothe r registrant's study, Iunderstand that this option is available **only** for acute toxicity or certain effi cacy data and **only** if the cited study was conducted on my product, an identical product or a product which EPA has "grouped" with one or mor e other products for purposes of depending on the sa me data. I may also choose this opti on if I am citing my own data. In either case, I will provide the **MRID o r**  **Accession number(s)** for the cited d ata on a "Product Specific Data Report" form or i n a similar format. By the specified due date, I will also submit: (1) a completed **"Certification Wit h Respect To Data Compensation Requirements"**  **form (EPA Form 8570-29)**  and (2) two completed and signed copies of th e **Confidential Statement of Formula (EPA Form 8570-4)**

.71

7. I req

uest a waiver for this study because it is inappropriate for my produc t ( **Wai ver** **Request**

). I am attaching a complete justification for this request , in cluding technical reasons, data and references to relevant EPA regulations , guideli nes

or policies. [Note: any supplemental data must be submitted in th e format requi red by P.R. Notice 86-5]. I understand that this is my **onl y**  opport unity to state the reasons or provide information in support of my request. If the Agency

approves my waiver request, I will **not** be required to supply th e data pu rsuant to Section 3(c)(2)(B) of FIFRA. If the Agency denies my waive r requ est, I **must choose**

a method of meeting the data requirements of this Notice by the due date stated by this Notice. In this case, I must, within **30 days** of my rece ipt of the Agency's written decision, submit a revised "Requirements Statu s and Registrant's R esponse" Form indicating the option chosen. I also understand that the deadline for submission of data as specified by the original data call-i n noti ce will not change. By the specified due date, I will also submit: (1) a completed **"Certification Wit h Respect To Data Compensation Requirements"**  **form (EPA Form 8570-29)**  and (2) two completed and signed copies of th e **Confidential Statement of Formula (EPA Form 8570-4)**

. Items 10-13. Self-explanatory. **NOTE** : You may provide **additional information** that does no

t fit on this form in a signed letter that accompanies this form . For example, you may wish to report that your product has already been tra nsferred to another company or that you have already voluntarily canceled this product. For these cases, please supply all relevan t details so that EPA can ensure that its records are correct.72

**Attachment 3.**  **Product Specific Requirement Status and R egistrant's Response Forms**  **(Form B inserts) and Instructions INST**  **RUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AN**  **D REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA**  Item 1-3. Completed b y EPA. Note the unique identifier number assigned by EPA in item 3. This number must be used in the transmittal docume nt for any data submissions in response to this Data Call-In Notice. Item 4. The

guid elines reference numbers of studies required to support the product' s cont inued registration are identified. These guidelines, in addition to th e requirements specified in the Notice, govern the conduct of the required studies. Note that s eries 61 and 62 in product chemistry are now listed under 40 CF R 158.155 through 158.180, Subpart c. Item 5. The study title associated with the guideline reference number is identified. Item 6. The

use pa tters (s) of the pesticide associated with the product specifi c requirements is

(are) identified. For most product specific data requirements, all use patterns are covered by the data requirements. In the case of efficacy data, the required studies only pertain to products which have the use sites and/ or pest s indicated. Item 7. The substance to be tested is identified by EPA. For product specific data, th e product as formulated for sale and distribution is the test substance, except in rare cases. Item 8. The due date for submiss ion of each study is identified. lt is normally based on 8 months a fter issuance of the Reregistration Eligibility Documents unless EP A determines that a longer time period is necessary. Item 9. Enter Only one of the following response codes for each data requirement to show how you intend to comply with the data requirements listed in this table. Fuller descriptions of each option are contained in the Data Call-In Notice. 1. I will generate and submit data by the specified due date (Deve loping Data). By indicating that I have chosen this option, I certify th at I will comply with all the requirements pertaini ng to the conditions for submittal of this study as outlined in the Data Call-In Notice. 2. I have entered into an agreement with one or more registrants to develop dat a jointly (Cost Sharing). I am submitting a copy of this agreement. I understand that this option is available on for a cute toxicity or certain efficacy data and only if EPA indicates in an attachment to this notice that m y product is similar. Enou gh to another product to qualify for this option. I certify that another party in th e agreement is committing to submit or provide the required data; if th e required study is n

ot submitted on time, my product my be subject to suspension. 3. I have made offers to share in the cost to develop data (Offers to Cos t Share). I understand tha

t this option is available only for acute toxicity or certain efficacy data and only if EPA indicates in an attachment t o this Data Call-In Notice that my prod

uct is similar enough to another product to qualify for this option. I am submitting evidence that I have made an offer to another registrant (who has an obligation to submit data) to share in the cost of that data. I am also submitting73 a completed " Certification of offer to Cost Sh are in the Development Data" form. I am including a copy of my offer and proof of the other registrant's receipt of that offer. I am identifying the party which is committing to submit or provide th e require data; if the required study is not submitted on time, my product may b e subje ct to suspension. I understand that other terms under Option 3 in the Dat a Call-In Notice (Section III-C.1.) apply as well. 4. By the specified due da te, I will submit an existing study that has not been su bmitted previously to the Agency by anyone (submitting an Existing Study). I certify that t

his study will meet all the requirements for submittal of existing data outlined in option 4 in the Data Call-In Notice (Section III-C.1.) and will meet the attached acceptance criteria (for acute toxicity and product chemistry data). I will a t tach the needed supporting information along with this response. I also certify that I have determined that this study will fill the data requir ement for which I have indicated this choice. 5. By

the specified due date, I will submit or cite data to upgrade a stud y classified by the Agency as partially acceptable and upgrade (upgrading a study). I will submi t evidence of the Agency's review indicating that the study may b e upgraded and

what information is required to do so. I will provide the MRID or Accession number of the study at the due date. I underst and that the conditions for this Option o

utlined Option 5 in the Data Call-In Notice (Section III-C.1.) apply. 6. By the specified due date, I will cite an existing study that the Agency has classi fied as acceptable or an existing study that has been submitted but no t reviewed by the Agency (Citing an Existing Study). If I am citing anothe r registrant's study

, I understand that this option is available only for acute toxicity or certain e

fficacy data and only if the cited study was conducted on my product, an identical product or a product which EPA has "grouped" with one or mor e other products for purposes of depending on the sa me data. I may also choose this option if I a m citing my own data. In either case, I will provide the MRID o r Accessio n number (s) number (s) for the cited data on a "Product Specific Dat a Report" form or in a similar format. If I cite another registratrant's data, I will sub mit a completed "Certification With Respect To Data Compensatio n Requirements" form. 7. I request a waiver for this study because it is inappropriate for my product (Wa iver Request). I am attaching a complete justification for this request , in cluding technical reasons, data and references to relevant EPA regulations , guid elines or policies. [Note: any supplemental data must be submitted in th e fo rmat required by P.R. Notice 86-5]. I understand that this is my onl y opport unity to state the reasons or provide information in support of my request. If the Agency approves my waiver request , I will not be require to supply the data purs uant to Section 3(c) (2) (B) of FIFRA. If the Agency denies my waive r request, I must choose a method of meeting the data requirements of this Notice by the due date stated by this Notice. In this case, I must, within 30 days of my rece ipt of the Agency's written decision, submit a revised "Requirements Statu s chosen. I also und

erstand that the deadline for submission of data as specified by the original data cal-in notice will not change.74

Items 10-13. Self-explanatory. NOTE: You may provi de additional information that does not fit on this form in a signed letter that accompanies this form. For example, you may wish to report that your product ha s alre ady been transferred to another company or that you have already voluntarily cancelled this product. For these cases, please supply all relevant details so that EPA can ensure that its records are correct.75

**Attachment 4.**  **EPA Batching of End-Use Products for Meeting Data Req uirements for**  **Reregistration EPA'S BATCHING OF SODIUM FLUOROACETATE PRODUCTS FOR MEETING**  **ACUTE TOXICITY DATA REQUIREMENTS FOR REREGISTRATION** In an effort to reduce the time, resources and number of animals needed to fulfill the acute toxicity data requirements for reregistration of products containing sodium fluoroacetate as the active ingredient, the Agency has batched products which can be considered similar for purposes of acute toxicity. Factors considered in the sorting process include each product's active and inert ingredients (identity, percent composition and biological activity), type of formulation (e.g., emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g., signal word, use classification, precautionary labeling, etc.). Note that the Agency is not describing batched products as "substantially similar" since some products within a batch may not be considered chemically similar or have identical use patterns. Using available information, batching has been accomplished by the process described in the preceding paragraph. Notwith-standing the batching process, the Agency reserves the right to require, at any time, acute toxicity data for an individual product should the need arise. Registrants of products within a batch may choose to cooperatively generate, submit or cite a single battery of six acute toxicological studies to represent all the products within that batch. It is the registrants' option to participate in the process with all other registrants, only some of the other registrants, or only their own products within a batch, or to generate all the required acute toxicological studies for each of their own products. If a registrant chooses to generate the data for a batch, he/she must use one of the products within the batch as the test material. If a registrant chooses to rely upon previously submitted acute toxicity data, he/she may do so provided that the data base is complete and valid by today's standards (see acceptance criteria attached), the formulation tested is considered by EPA to be similar for acute toxicity, and the formulation has not been significantly altered since submission and acceptance of the acute toxicity data. Regardless of whether new data is generated or existing data is referenced, registrants must clearly identify the test material by EPA Registration Number. If more than one confidential statement of formula (CSF) exists for a product, the registrant must indicate the formulation actually tested by identifying the corresponding CSF. In deciding how to meet the product specific data requirements, registrants must follow the directions given in the Data Call-In Notice and its attachments appended to the RED. The DCI Notice contains two response forms which are to be completed and submitted to the Agency within 90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant will meet the data requirements for each product. The second form, "Requirements Status and Registrant's Response," lists the product specific data required for each product, including the standard six acute toxicity tests. A registrant who wishes to participate in a batch must decide whether he/she will provide the data or depend on someone else to do so. If a registrant supplies the data to support a batch of products, he/she must select one of the following options: Developing Data (Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing Study (Option 5) or Citing an Existing Study (Option 6). If a registrant depends on another's data, he/she must choose among: Cost Sharing (Option 2), Offers to Cost Share (Option 3) or Citing an Existing Study (Option 6). If a registrant does not want to participate in a batch, the choices are Options 1, 4, 5 or 6. However, a registrant should know that choosing not to participate in a batch does not preclude other registrants in the batch from citing his/her studies and offering to cost share (Option 3) those studies. Seven products were found which contain sodium fluoroacetate as the active ingredient. The products have been placed into one batch and a "no batch" category in accordance with76

the active and inert ingredients, type of formulation and current labeling. Table 1 identifies the products in the batch. Table 2 lists the product which has been placed in the "no batch" category. Table 1 Batch EPA Reg. No. % Active Ingredient Formulation Type 1 13808-7 1.0 Liquid

35975-4 1.0 Liquid 35978-8 1.0 Liquid 39508-2 1.0 Liquid 46779-1 1.0 Liquid 56228-22 1.0 Liquid The following table lists a product that was either considered not to be similar or the Agency lacked sufficient information for decision making and were not placed in any batch. The registrant of this product is responsible for meeting the acute toxicity data requirements separately. Table 2 (No Batch) EPA Reg. No. % Active Ingredient Formulation Type 56228-26 90.0 Solid77



## Attachment **5. List of All Registrants Sent This Data**  **Call-In (insert) Notice**79

**Attachment 6.**  **Cost Share, Data Compensation Forms, Confidential Statement of Formula Form and Instructions**  

### Instructions for Completing the Confidential Statement of Formula The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed copies of the form are required. Following are basic instructions: a. All the blocks on the form must be filled in and answered completely. b. If any block is not applicable, mark it N/A.

c. The CSF must be signed, dated and the telephone number of the responsible party must be provided. d. All

applicable information which is on the product specific data submission must also be reported on the CSF.

e. All w

eights reported under item 7 must be in pounds per gallon for liquids an d pounds per cubic feet for solids. f. Flashpoint must be in degrees Fahrenheit and flame extension in inches. g. For

all a ctive ingredients, the EPA Registration Numbers for the currentl y registered source products must be reported under column 12. h. The Chemical Ab

stracts Service (CAS) Numbers for all actives and inerts and all common names for the trade names must be reported. i. For

th e active ingredients, the percent purity of the source products must b e reported under column 10 and must be exactly the same as on the source product's label. j. All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, o r grams. In no case will volumes be accepted. Do not mix Englis h and metric system units (i.e., pounds and kilograms). k. All the items under column 13.b. must total 100 percent. 1. All items under columns 14.a. and 14.b. for the active ingredients must represent pure active form.

m. The upper and lower certified limits for ail active and ine rt ingredients must follow the 40 CFR 158.175 instructions. An explanation must be provided if the proposed limits are different than standard certified limits.

n. When

new CSFs are submitted and approved, all previously submitted CSF s become obsolete for that specific formulation.808182838485 United States Environmental Protection Agency 2070-0057

Washington, DC 20460 Approval Expires

CERTIFICATION WITH RESPECT TO DATA COMPENSATION REQUIREMENTS Form Approved OMB No. 2070-0107,

3-31-96

Public reporting burden for this collection of information is estimated to average 15 minutes per response, including time for reviewing instru ctions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to, Chief Information Policy Branch, PM-233, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503. Please fill in blanks below. Company Name Company Number

Product Name EPA Reg. No.
I Certify that: 1. For each study cited in support of registration or reregistratiion under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the written permission of the original data submitter to cite that study. 2. That for each study cited in support of registration or reregistration under FIFRA that is NOT an exclusive use study, I am the original data submitter, or I have obtained the written permission of the original data submitter, or I have notified in writing the company(ies) that submitted data I have cited and have offered to: (a) Pay compensation for those data in accordance with sections 3(c)(1)(F) and 3(c)(2)(D) of FIFRA; and (b) Commence negotiation to determine which data are subject to the compensation requirement of FIFRA and the amount of compensation due, if any. The companies I have notified are. (check one) [ ] The companies who have submitted the studies listed on the back of this form or attached sheets, or indicated on the attached "Requirements Status and Registrants' Response Form," 3. That I have previously complied with section 3(c)(1)(F) of FIFRA for the studies I have cited in support of registration or reregistration under FIFRA.

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GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the registration or reregistration of my products, to the extent required by FIFRA section 3(c)(1)(F) and 3(c)(2)(D).

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EPA Form 8570-31 (4-96)86 **APPENDIX E.**  **List of Available Related Documents** The fo llowing is a list of available documents related to sodium fluoroacetate. It's purpose is to provide a path to more detailed infor mation if it is needed. These accompanying documents are part of t he Administrative Record for Sodium fluoroacetate and are included in the EPA' s Office of Pesticide Programs Public Docket. 1. Health and Environmental Effects Science Chapters 2. Detailed Label Usage Information System (LUIS) Report 3. Sodium fluoroacetate RED Fact Sheet 4. PR Notice 86-5 (included in this appendix) 5. PR N otice 91-2 (included in this appendix) pertains to the Label Ingredien t Statement