Docket Number EPA-HQ-OPP-2010-0753 

www.regulations.gov

Fluoroacetic Acid Derivatives Summary Document 

Registration Review: Initial Docket 

September 2010 

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TABLE OF CONTENTS 

 Page # 

I. Preliminary Work Plan (PWP) 4 

II. Fact Sheet 9 

 

This Preliminary Work Plan and Fact Sheet summarize the Environmental Protection Agency’s 

current position based on the following documents: 

1. EFED Registration Review Problem Formulation for Sodium Fluoroacetate (1080), 

September 20, 2010 

2. Sodium Fluoroacetate and 2-Fluoroacetamide: Human Health Risk Scoping Document in 

Support of Registration Review, September 8, 2010 

3. Uses Considered in Registration Review Work Planning – Sodium 

fluoroacetate (075003), September 2009

5. Sodium Fluoroaceate Derivatives: Review of Human Incidents, February 25, 2010 

6. Environmental Protection Agency’s (EPA) Response to the Petition and Addenda 

Requesting that EPA Suspend and Cancel the Registrations of the Predator Control Uses 

of Sodium Cyanide and Sodium Fluoroacetate (Compound 1080), January 16, 2009 

All supporting documents for the registration review of sodium fluoroacetate are located in 

docket EPA-HQ-OPP-2010-0753 at http://www.regulations.gov. 
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I. PRELIMINARY WORK PLAN – Fluoroacetic Acid Derivatives 

Introduction

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review 

program. All pesticides distributed or sold in the United States (U.S.) generally must be 

registered by the Environmental Protection Agency (EPA or the Agency), based on scientific 

data showing that they will not cause unreasonable risks to human health or the environment 

when used as directed on product labeling. The registration review program is intended to make 

sure that, as the ability to assess risk evolves and as policies and practices change, all registered 

pesticides continue to meet the statutory standard of no unreasonable adverse effects to human 

health or the environment. Changes in science, public policy, and pesticide use practices will 

occur over time. Through the registration review program, the Agency periodically reevaluates 

pesticides to make sure that as change occurs, products in the marketplace can be used safely. 

Information on this program is provided at: http://www.epa.gov/oppsrrd1/registration_review/ . 

The Agency is implementing the registration review program pursuant to Section 3(g) of 

the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and will review each 

registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard 

for registration. The Agency will consider benefits information and data as required by FIFRA. 

The public phase of registration review begins when the initial docket is opened for each case. 

The docket is the Agency’s opportunity to state what it knows about the pesticide and what 

additional risk analyses and data or information it believes are needed to make a registration 

review decision. After reviewing and responding to comments and data received in the docket 

during this initial comment period, the Agency will develop and commit to a final work plan and 

schedule for the registration review of sodium fluoroacetate. It should be noted that sodium 

fluoroacetate is the only active ingredient in the fluoroacetic acid derivatives registration review 

case. 2-fluoroacetamide was initially included in the fluroacetic acid derivatives case, however 

this chemical was cancelled in 1989 and there are no active pesticide registrations in the United 

States. Therefore, 2-fluoroacetamid will not be considered in this registration review. 

Sodium fluoroacetate (Compound 1080) is an acute toxicant used for predator control and 

is registered for use in livestock protection collars (1080 LPC) to control coyotes that prey upon 

sheep or goats. A summary of the issues relevant to the registration review of Compound 1080 

is presented below. 

Anticipated Risk Assessment and Data Needs

A new ecological risk assessment and additional ecological toxicity and environmental 

fate data are not anticipated as being needed for sodium fluoroacetate in support of registration 

review. However, as outlined in the Agency’s response to the petition and addenda (filed on 

January 24, 2007, March 20, 2007, July 27, 2007 and January 7, 2008) requesting that EPA 

suspend and cancel the registration of the predator control uses of sodium cyanide (M-44) and 
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sodium fluoroacetate (Compound 1080), the Agency will conduct an endangered species 

assessment for the registered use of Compound 1080. A new human health risk assessment and 

additional data are not needed for Compound 1080 in support of registration review. 

Ecological Risk: 

• As part of the Agency’s response to the petition and addenda requesting that EPA 

suspend and cancel the registration of the predator control uses of sodium cyanide (M-44) 

and sodium fluoroacetate (Compound 1080), the Agency has initiated informal 

consultation with the United States Fish and Wildlife Service (USFWS) and intends to 

reinitiate formal consultation with the USFWS as part of this registration review. 

• On April 15, 1991 EPA initiated consultation for 16 vertebrate control agents including 

Compound 1080 in livestock protection collars (1080 LPC). The USFWS issued a 

Biological Opinion (BO) in March 1993. For the 1080 LPC, the BO found that this 

registration could affect the gray wolf and black bear. FWS identified specific state and 

county areas where 1080 LPCs could not be used and concluded that implementation of 

such restriction would preclude jeopardy to both the gray wolf and the grizzly bear. 

Incidental take was not permitted. The 1080 Compound labels were amended to identify 

the specific listed species. In the 1994 RED EPA concluded that the use of Compound 

1080 did not pose unreasonable risks to the environment if this product was used in 

accordance with the established use restrictions. Per this registration review, EPA will 

reinitiate formal consultations with FWS in accordance with Section 7 of the Endangered 

Species Act (USFWS/NMFS, 1998) to confirm that the current measures remain 

adequately protective of listed species identified in the 1993 BO and if necessary will 

recommend additional measures for new listed species. 

• For further information please refer to the EFED Registration Review Problem 

Formulation for Sodium Fluoroacetate (1080) (September 20, 2010), which is available 

in the docket at: http://www.regulations.gov

Human Health Risk: 

• EPA has reviewed the existing toxicology database and most recent human health 

exposure and risk assessments for Compound 1080 and has determined that these data 

and assessments are adequate based on current methodologies. Therefore, a new human 

health risk assessment and additional data are not anticipated as being needed in support 

of this registration review. 

• Sub-chronic dermal toxicity, prenatal developmental toxicity (rat and rabbits), rat 

reproduction, mutagenicity, neurotoxicity, and immunotoxicity studies are typically 

required for registration of a non-food use pesticide (40 CFR Part 158). These data are 

not available for sodium fluoroacetate. However, these data are needed for the following 
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reasons: (1) based on the very narrow use pattern, workers are the only potentially 

exposed subpopulation; and (2) given that sodium fluoroacetate is fully enclosed in the 

collars and its use is strictly limited to trained and certified personnel only, occupational 

exposure is not expected to occur. Therefore, the available data are adequate to assess 

human health risks associated with registered uses of sodium fluoracetate and additional 

toxicity data are not anticipated as being needed. 

• For further information please refer to the Sodium Fluoroacetate and 2-Fluoroacetamide: 

Human Health Assessment Scoping Document in Support of Registration Review

(September 8, 2010), which is available in the docket at: http://www.regulations.gov

Endocrine Disruptor Screening Program

As required under FFDCA section 408(p), EPA has developed the Endocrine Disruptor 

Screening Program (EDSP) to determine whether certain substances (including pesticide active 

and other ingredients) may have an effect in humans or wildlife similar to an effect produced by 

a “naturally occurring estrogen, or other such endocrine effects as the Administrator may 

designate.” The EDSP employs a two-tiered approach to making the statutorily required 

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a 

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine related effects caused by the substance, and 

establish a quantitative relationship between the dose and the E, A, or T effect. 

Between October 2009 and February 2010, EPA issued test orders/data call-ins for the 

first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert 

ingredients. This list of chemicals was selected based on the potential for human exposure 

through pathways such as food and water, residential activity, and certain post-application 

agricultural scenarios. This list should not be construed as a list of known or likely endocrine 

disruptors. 

Sodium fluoracetate is not among the group of 58 pesticide active ingredients on the 

initial list to be screened under the EDSP. Under FFDCA sec. 408(p) the Agency must screen all 

pesticide chemicals. Accordingly, EPA anticipates issuing future EDSP orders/data call-ins for 

all Registration Review cases, including those for which EPA has already opened a Registration 

Review docket for a pesticide active ingredient. 

For further information on the status of the EDSP, the policies and procedures, the list of 

67 chemicals, the test guidelines and the Tier 1 screening battery, please visit our website: 

http://www.epa.gov/endo/. 
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Timeline

 

The Agency has created the following estimated timeline for the completion of the 

sodium fluoroacetate registration review. 

Registration Review for Sodium Fluoroacetate – Projected Registration Review Timeline

Activities Estimated Date 

Opening the docket 

Open Docket and Public Comment Period 2010 – September 

Close Public Comment 2010 – November 

Case Development 

Final Work Plan 2011 – February 

Open Public Comment Period for Preliminary Risk Assessments 2013 – Jan.- March 

Close Public Comment Period 2013 – April – June 

Registration Review Decision 

Open Public Comment Period for Proposed Registration Review 

Decision 

2013 – July – Sept. 

Close Public Comment Period 2013 – Oct. – Dec. 

Final Registration Review Decision and Begin Post-Decision Follow-up 2014 

Total (years) 4 

Guidance for Commenters

The public is invited to comment on EPA’s preliminary registration review work plan 

and rationale. The Agency will carefully consider all comments, as well as any additional 

information or data provided in a timely manner, prior to issuing a final work plan for the sodium 

fluoroacetate case. 

Environmental Justice: 

EPA seeks to achieve environmental justice, the fair treatment and meaningful 

involvement of all people, regardless of race, color, national origin, or income, in the 

development, implementation, and enforcement of environmental laws, regulations, and policies. 

To help address potential environmental justice issues, the Agency seeks information on any 

groups or segments of the population who, as a result of their location, cultural practices, or other 

factors, may have atypical, unusually high exposure to sodium fluoroacetate compared to the 

general population. Please comment if you are aware of any sub-populations that may have 

atypical, unusually high exposure, compared to the general population. 
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Water Quality: 

Sodium fluoracetate is not identified as a cause of impairment for any water bodies listed 

as impaired under section 303(d) of the Clean Water Act, based on information provided at 

http://iaspub.epa.gov/tmdl_waters10/attains_nation_cv.cause_detail_303d?p_cause_group_id=88

5. In addition, no Total Maximum Daily Loads (TMDL) have been developed for sodium 

fluoroacetate, based on information provided at 

http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id

=885&p_pollutant_group_name=PESTICIDES. More information on impaired water bodies and 

TMDLs can be found at http://www.epa.gov/owow/tmdl/. The Agency invites submission of 

water quality data for this pesticide. To the extent possible, data should conform to the quality 

standards in Appendix A of the OPP Standard Operating Procedure: Inclusion of Impaired 

Water Body and Other Water Quality Data in OPP’s Registration Review Risk Assessment and 

Management Process (see: 

http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm), in order to ensure 

they can be used quantitatively or qualitatively in pesticide risk assessments. 

Additional Information: 

Stakeholders are also specifically asked to provide information and data that will assist the 

Agency in refining risk assessments, including any species-specific ecological effects 

determinations. The Agency is interested in receiving any ecological incidents information 

specific to sodium fluoroacetate (non-target and avian and mammalian mortalities) that has not 

already been reported to the Agency. 

Next Steps

After the 60-day comment period closes, the Agency will review and respond to any 

comments received in a timely manner and then expects to issue a Final Work Plan in December 

of 2010 for sodium fluoroacetate. 
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II. FACT SHEET 

Background Information

• Fluoroacetic Acid Derivatives registration review case number: 3073 

• Sodium fluoroacetate (Compound 1080) PC Code: 075003 ; CAS # 62-74-8 

• Sodium fluoroacetate was first registered in the United States in 1947 

• A Reregistration Eligibility Decision (RED) was issued in 1995 

• Technical registrant: United States Department of Agriculture, Animal Plant Health 

Inspection Service (USDA, APHIS) 

• There are 7 FIFRA Section 3 active product registrations (1 technical registration & 6 

end-use registrations) 

• Pesticide Re-evaluation Division Contact: K. Avivah Jakob (Jakob.kathryn@epa.gov) 

• Registration Division Contact: Bill Jacobs (Jacobs.bill@epa.gov) 

Use and Usage Information 

 For additional details, please refer to Uses Considered in Registration Review Work 

Planning – Sodium fluoroacetate (075003) in the sodium fluoroacetate docket.

• Compound 1080 is classified as a restricted use pesticide (RUP) may only be applied by 

certified applicators. There are several label restrictions for its use which greatly limit 

the exposure and risk potential of this pesticide. 

• Compound 1080 is a predicide which is registered for use in livestock protection collars 

(1080 LPC) to control coyotes that prey upon sheep or goats. 

• The only Compound 1080 end-use product is the 1080 LPC, which consists of two rubber 

bladders and two sets of velcro or elastic straps. Prior to distribution of the collar, each 

of the bladders is injected with 15 ml of a 1% Compound 1080 solution. For proper use, 

LPCs are strapped to a sheep or goat such that the bladders straddle the throat area. 

Coyotes attempting to kill a collared animal are likely to puncture the reservoir and be 

fatally poisoned by Compound 1080. 

Pending and Recent Actions

• In January 2009 EPA issued a response to the petition and addenda filed January 24, 

2007, March 20, 2007, July 27, 2007 and January 7, 2008 requesting that EPA suspend 

and cancel the registration of the predator control uses of sodium cyanide (M-44) and 

sodium fluroacetate (Compound 1080). EPA denied the request to suspend and cancel 

the predator control uses of these two chemicals because it was determined that the use of 

these devises does not create unreasonable adverse effects on the environment under 

FIFRA and that the registrations meet the FIFRA eligibility standards. 
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Ecological Risk Assessment Status

The following are key findings of the ecological risk assessments conducted to support 

the registered uses of sodium fluoroacetate. For a detailed discussion of previous ecological risk 

assessments refer to the EFED Registration Review Problem Formulation for Sodium 

Fluoroacetate (1080) (September 20, 2010), which is located in the docket. 

• The most recent ecological risk assessment was completed in 1995 in support of the 

sodium fluoroacetate Reregistration Eligibility Decision (RED). 

• Although there are a small number of reports of punctured collars leaking in the 

environment, the primary environmental concerns identified in previous risk assessments 

are the potential adverse effects upon the survival of non-target terrestrial vertebrates, 

including endangered and non-endangered species, resulting from primary (contaminated 

sheep or goat carcasses with either broken/punctured or unbroken collars; and/or toxicant 

spilled on the ground or vegetation when a collar is punctured) and secondary (carcasses 

of coyotes killed by Compound 1080 LPC and not removed; and/or vomitus of poisoned 

coyotes) exposure and poisoning. 

• In the 1995 RED EPA concluded that the use of Compound 1080 did not pose 

unreasonable risks to the environment if this product was used in accordance with the use 

restrictions. 

• The 1993 Biological Opinion (BO) found that the use of Compound 1080 could affect 

several listed species. However, FWS determined that if certain reasonable and prudent 

alternatives and measures were adopted, the registration would not jeopardize the 

continued existence of these species. 

Human Health Risk Assessment Status

The following are key findings of the human health risk assessments conducted to 

support the registered uses of Compound 1080. For a detailed discussion of previous human 

health risk assessments refer to the Sodium Fluoroacetate and 2-Fluoroacetamide: Human 

Health Risk Scoping Document in Support of Registration Review (September 8, 2010), which is 

located in the docket. 

• The most recent human health risk assessment for Compound 1080 was conducted in 

1994 in support of the 1995 Reregistration Eligibility Decision (RED). The 1994 risk 

assessment addressed occupational exposures and risk associated with the use of 

Compound 1080 in livestock protection collars (LPCs). 
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Hazard Characterization: 

• Compound 1080 has high acute toxicity via the oral (Category I) and dermal (Category 

II) routes of exposure. It is a slight eye irritant, however it is not a dermal irritant and it is 

not a skin irritant or sensitizer. Requirements for acute inhalation toxicity and dermal 

sensitization studies were waived due to the severe acute toxicity of the compound and 

the restriction of its use in livestock protection collars only. 

Dietary Risk: 

• A dietary (food) exposure assessment has not been conducted because there are no 

registered food/feed uses. 

• A qualitative assessment of potential drinking water exposure was conducted in 1994 and 

EPA determined that this route of exposure and the volume released would not threaten 

either surface water through runoff or ground water through leaching. Therefore, a 

quantitative drinking water exposure assessment was not conducted. 

Residential Risk: 

• There are no registered residential uses of sodium fluoroacetate; therefore, residential 

exposure has not been previously assessed. 

Aggregate Risk: 

• An aggregate exposure assessment has not been previously conducted because it is 

believed that sodium fluoroacetate use does not result in residential and/or dietary 

exposure. 

Occupational Risk: 

• The 1994 occupational exposure assessment concluded that, based on the use 

information, there are no significant risks to workers from applicator or post-applicator 

exposure to Compound 1080. 

Cumulative assessment: 

• EPA does not have, at this time, available data to determine whether Compound 1080 has 

a common mechanism of toxicity with other substances. EPA has not made a common 

mechanism of toxicity finding for Compound 1080 and any other substances and, 

Compound 1080 does not appear to produce a toxic metabolite produced by other 

substances which have tolerances in the U. S. Therefore, EPA has not assumed that 

Compound 1080 has a common mechanism of toxicity with other substances. 

Incidents

• A preliminary review of the Ecological Incident Information System (EIIS) and the 

Avian Monitoring Information System (AIMS) Database identified eight ecological 

incidents associated with the use of Compound 1080. The EIIS database describes nine 
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terrestrial animal incidents, covering a period from 1984-2003. However, one of those 

incidents (IO05417-004, in 1989) is classified as unlikely. There are also two incidents 

from Idaho classified as probable that were determined to be misuses of 1080 (IO19079-

007, in 2000 and IO19079-008, in 2003). Mortality is reported for fifty-eight ravens in 

California, this incident is classified as possible (I005417-003, in 1989). Four incidents 

from Idaho reporting mortality of one gray wolf (per incident) are classified as highly 

probable (IO19079-003 in 1999, IO19079-005 in 1999, IO19079-006 in 2000 and 

IO19079-004 in 2000). No aquatic or plant incidents were reported in the EIIS database 

for Compound 1080. 

• An updated human incident report was recently conducted for Compound 1080 by 

consulting the OPP Incident Data System (IDS) and the Centers for Disease Control and 

Prevention/National Institute for Occupational Safety and Health Sentinel Event 

Notification System for Occupational Risk-Pesticides. No human incidents have been 

reported from 1998 to present. 

Tolerances and International Harmonization

• There are no registered food/feed uses and no established tolerances for the registered use 

of Compound 1080. Codex maximum residue limits (MRLs) do not currently exist.

Data Call-In Status

• A generic data call-in (GDCI) was issued in 1992 (GDCI-075003-17047) and in 1993. 

(GDCI-075003-17381) 

• A product specific data call-in (PDCI-075003-0110) was issued in 1995.

Labels 

• Active Section 3 labels for Compound 1080 can be obtained from the Pesticide Product 

Label System (PPLS) website: http://oaspub.epa.gov/pestlabl/ppls.home.