Docket Number EPA-HQ-OPP-2010-0753 www.regulations.gov

Fluoroacetic Acid Derivatives Summary Document Registration Review: Initial Docket September 20103 TABLE OF CONTENTS

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I. Preliminary Work Plan (PWP) 4

II. Fact Sheet 9

This Preliminary Work Plan and Fact Sheet su mmarize the Environmental Protection Agency’s current position based on the following documents:

1. EFED Registration Review Problem Formul ation 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 Regi strations of the Predator Control Uses of Sodium Cyanide and Sodium Fluoroacetate (Compound 1080), January 16, 2009

All supporting documents for the registration revi ew of sodium fluoroacetate are located in docket EPA-HQ-OPP-2010-0753 at h ttp://www.regulations.gov.4 I. PRELIMINARY WORK PLAN – Fl uoroacetic Acid Derivatives

Introduction

The Food Quality Protection Act (FQPA) of 1996 mandated a re gistration review program. All pesticides distributed or sold in the United States (U.S .) generally must be registered by the Environmental Protection Agen cy (EPA or the Agency), based on scientific data showing that they will not cause unreasonab le 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 a nd as policies and practices change, all registered pesticides continue to meet th e statutory standard of no unreas onable 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/

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The Agency is implementing the registration re view program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rode nticide Act (FIFRA), and will review each registered pesticide every 15 years to determine wh ether it continues to m eet the FIFRA standard for registration. The Agency will consider benef its information and data as required by FIFRA. The public phase of registration review begins wh en the initial docket is opened for each case. The docket is the Agency’s opportunity to stat e what it knows about the pesticide and what additional risk analyses and data or information it believes ar e 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 fl uoroacetate. It should be noted that sodium fluoroacetate is the only active ingr edient in the fluoroacetic acid derivatives registration review case. 2-fluoroacetamide was initially included in the fluroacetic acid de rivatives case, however

this chemical was cancelled in 1989 and there ar e 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 ac ute toxicant used for predator control and is registered for use in livest ock protection collars (1080 LPC) to control coyotes that prey upon sheep or goats. A summary of the issues rele vant to the registrati on review of Compound 1080 is presented below.

Anticipated Risk Assessment and Data Needs

A new ecological risk assessment and additi onal ecological toxicity and environmental fate data are not anticipated as being needed for sodium fluoro acetate 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) and5 sodium fluoroacetate (Compound 1080), the Ag ency 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 th e petition and addenda requesting that EPA suspend and cancel the registration of the predat or control uses of sodium cyanide (M-44) and sodium fluoroacetate (Compound 1080), the Agency has initiated informal

consultation with the United States Fish a nd 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 fo r 16 vertebrate cont rol agents including Compound 1080 in livestock protection colla rs (1080 LPC). The USFWS issued a Biological Opinion (BO) in March 1993. Fo r the 1080 LPC, the BO found that this registration could affect the gr ay wolf and black bear. FW S identified specific state and county areas where 1080 LPCs could not be us ed 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 conclude d that the use of Compound 1080 did not pose unreasonable risks to the en vironment if this product was used in

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

reinitiate formal consultations with FWS in accordance with Secti on 7 of the Endangered Species Act (USFWS/NMFS, 1998) to confir m that the current measures remain adequately protective of list ed species identified in th e 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 10 80 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 deve lopmental toxicity (rat and rabbits), rat reproduction, mutagenicity, neurotoxicity, and immunotoxicity st udies are typically required for registration of a non-food use pe sticide (40 CFR Part 158). These data are

not available for sodium fluoroacetate. Howe ver, these data are needed for the following6 reasons: (1) based on the very narrow use pattern, workers are the only potentially exposed subpopulation; and (2) given that sodi um fluoroacetate is fully enclosed in the collars and its use is strictly limited to trai ned 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 fluor acetate and additional toxicity data are not antici pated as being needed.

• For further information please refer to the Sodium Fluoroacetate and 2-Fluoroacetamide: Human Health Assessment Scoping Docu ment in Support of Registration Review (September 8, 2010), which is av ailable in th e docket at: http://www.regulations.gov

Endocrine Disruptor Screening Program

As required under FFDCA section 408(p), EP A has developed the Endocrine Disruptor Screening Program (EDSP) to determine whether certain substances (inc luding pesticide active and other ingredients) may have an effect in humans or wildlife si milar 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 ap proach 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 estrog en, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go th rough Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stag e of the EDSP where EPA will determine which, if any, of th e Tier 2 tests are necessary base d on the available data. Tier 2 testing is designed to identify a ny adverse endocrine related eff ects caused by the substance, and establish a quantitative relationship betw een the dose and the E, A, or T effect.

Between October 2009 and February 2010, EPA issu ed 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 sele cted based on the potenti al for human exposure through pathways such as food and water, resi dential activity, and cer tain 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 anticipat es issuing future EDSP orders/data call-ins for all Registration Review cases, in cluding those for which EPA ha s already opened a Registration Review docket for a pestic ide active ingredient.

For further information on the status of the ED SP, the policies and procedures, the list of 67 chemicals, the test guidelines and the Tier 1 screening battery, plea se visit our website: http://www.epa.gov/endo/

.7 Timeline

The Agency has created the following estimated timeline for the completion of the sodium fluoroacetate registration review.

Registration Review for Sodi um Fluoroacetate – Projected Registration Review Timeline

Activities Estimated Date Opening the docket Open Docket and Public Co mment 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 comme nt on EPA’s preliminary regi stration 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, pr ior to issuing a final wo rk plan for the sodium

fluoroacetate case.

Environmental Justice :

EPA seeks to achieve environmental justi ce, 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 envir onmental justice issues, the Agency seeks information on any groups or segments of the population who, as a resu lt of their location, cultur al practices, or other factors, may have atypical, unusually high expos ure 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.8 Water Quality :

Sodium fluoracetate is not iden tified as a cause of impairme nt 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_de tail?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 exte nt possible, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedur e: Inclusion of Impaired Water Body and Other Water Quality Data in OPP’s Regist ration Review Risk Assessment and Management Process (see: http://www.epa.gov/oppsrrd1/regist ration_review/water_quality_sop.htm) , in order to ensure they can be used quantitatively or qual itatively in pesticide risk assessments.

Additional Information :

Stakeholders are also specifically asked to prov ide information and data that will assist the Agency in refining risk assessments, includ ing 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, th e Agency will review and respond to any comments received in a timely manner and then exp ects to issue a Final Work Plan in December

of 2010 for sodium fluoroacetate.9 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 regi stered in the United States in 1947

• A Reregistration Eligibility Deci sion (RED) was issued in 1995

• Technical registrant: United States Departme nt of Agriculture, Animal Plant Health Inspection Service (USDA, APHIS)

• There are 7 FIFRA Section 3 active product re gistrations (1 techni cal registration & 6 end-use registrations)

• Pesticide Re-evaluation Di vision 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 labe l restrictions for its use which greatly limit the exposure and risk poten tial 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 th at the bladders straddl e the throat area. Coyotes attempting to kill a co llared animal are likely to punc ture 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 co ntrol uses of sodium cyanide (M-44) and sodium fluroacetate (Compound 108 0). EPA denied the request to suspend and cancel the predator control uses of these two chemi cals 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.10 Ecological Risk Assessment Status

The following are key findings of the ecologi cal risk assessments conducted to support the registered uses of sodium fluoroacetate. Fo r 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 Reregistrati on 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 surviv al of non-target terrestrial vertebrates, including endangered and non-endangered specie s, resulting from primary (contaminated sheep or goat carcasses with ei ther 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 determ ined 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. Fo r a detailed discussi on 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 a ssessment 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 pr otection collars (LPCs).11 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 sensi tizer. Requirements for acute i nhalation toxicity and dermal

sensitization studies were waived due to th e severe acute toxic ity of the compound and

the restriction of its use in liv estock 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 drinki ng 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 exposur e 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 b een previously conducted because it is

believed that sodium fluoroacetate use does not result in residen tial 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 othe r substances. EPA has not made a common mechanism of toxicity finding for Com pound 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 to xicity with other substances.

Incidents

• A preliminary review of the Ecological In cident 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 nine12 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 pr obable 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 incide nts were reported in the EIIS database
for Compound 1080.

• An updated human incident report wa s recently conducted for Compound 1080 by consulting the OPP Incident Data System (ID S) and the Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health Sentinel Event Notification System for Occupa tional 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 issu ed in 1992 (GDCI-075003-17047) and in 1993. (GDCI-075003-17381)

• A product specific data call-in (P DCI-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

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