Docket Number EPA-HQ-OPP-2010-0752 www.regulations.gov

Sodium Cyanide (M-44) Summary Document Registration Review: Initial Docket September 20103 TABLE OF CONTENTS

Page #

I. Preliminary Work Plan (PWP) 4

II. Fact Sheet 10

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 Form ulation for Sodium Cyanide (M-44), September 20, 2010

2. Sodium Cyanide: Human Health Risk Sc oping Document in Support of Registration
Review, September 8, 2010

3. Food/Feed & Non-Food/Non-Feed Us es Considered in Registration Review Work Planning – Sodium cyanide (074002), July 6, 2009

4. Sodium cyanide (074002) California Departm ent of Pesticide Regulation (CADPR) Usage Data, November 3, 2009

5. Sodium Cyanide: Review of Human Incidents, May 20, 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 cyanide are located in docket EPA-HQ-OPP-2010-0752 at http ://www.regulations.gov.4 I. PRELIMINARY WORK PLAN – Sodium Cyanide

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/

.

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 cyanide.

Sodium cyanide was initially registered in the United States as a pesticide in 1947. A Reregistration Eligibility Decision (RED) and Tolerance Reassessment Eligibility Decision (TRED) for sodium cyanide were issued in 1994 and 2006, respectively. Sodium cyanide is currently registered as a restricted use predicid e and as a restricted us e insecticide. As a predicide, sodium cyanide is manufactured as an encapsulated singl e dose poison, which is inserted into an M-44 spring-lo aded ejector device, to contro l animals (foxes, coyotes, feral dogs) that prey upon livestock or threatened or endangered species. Sodium cyanide is not currently registered for any food or feed uses. However, there is one Special Local Needs (SLN) registration under Section 24(c) for use in Californ ia as an insecticide in which sodium cyanide is used as a source of hydrocyanic gas for qua rantine fumigation of su rface pests on citrus bound

for Arizona.

A summary of the issues relevant to the registration review of sodium cyanide is presented below.5 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 cyanide 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 sodium fluoroacetate (Compound 1080), the Agency will conduct an endangered species risk assessment for all uses of sodium cyanide. A new human health risk assessment and additional data are not needed for sodium cyanid e 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 sodium cyanide used in M-44 spring-loaded ejectors. The USFWS issued a Biological Opinion (BO) in March 1993. For M-44, the BO found that this registration could affect the Florida panther, gray wolf, grizzly bear , jaguarondi, Louisiana black bear, ocelot, San Joaquin kit fox, California condor, Hawaiia n crow, and the Mariana crow. FWS determined that if certain reasonable and prude nt alternatives and measures were adopted, the registration would not jeopa rdize the continued existen ce of these species. The sodium cyanide M-44 labels were amended to identify the specific listed species. In the

1994 RED EPA concluded that the use of M- 44 did not pose unreasonable risks to the environment if the product was used in accordan ce with the established use restrictions. Per this registration review, EPA will rein itiate formal consultations with FWS in accordance with Section 7 of the Endange red 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 Cyanide (M-44) (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 sodium cyan ide and has determined that these data and6 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 registration review.

• EPA does not anticipate needing immunotoxicity data because availa ble toxicity data provide no evidence of immunotoxic potential for cyanide compounds. Additionally, metabolism studies indicate that cyanide is metabolized to naturally occurring constituents that are not likely to provoke an immune response.

• The tolerance expression in 40 CFR 180.130 will be reviewed during registration review to ensure that it appropriately covers the me tabolites and degradates of sodium cyanide and that it specifies the residues to be measured for each commodity.

• For further information please refer to the Sodium Cyanide: Human Health Assessment Scoping Document in Support of Registration Review (September 8, 2010), which is

available in the docket at 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 cyanide is not among the group of 58 pesticide active ingred ients on the initial

list to be screened under the EDSP. Under FFD CA sec. 408(p) the Agency must screen all pesticide chemicals. Accordingly, EPA anticipat es issuing future EDSP orders/data call-ins for7 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/

.

Timeline

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

Registration Review for Sodium Cyanide – 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 cyanide case.

Trade Irritants :

Through the registration review process, th e Agency intends to solicit information on trade irritants and, to the extent feasible, take steps toward facilitating irritant resolution.

Growers and other stakeholders are asked to comme nt on any trade irritant issues resulting from

lack of Maximum Residue Limits (MRLs) or disparities between U.S. tolerances and MRLs in8 key export markets, providing as much specifici ty as possible regarding the nature of the

concern.

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, unus ually high exposure to sodium cy anide compared to the general population. Please comment if you are aware of any sub-populati ons that may have atypical, unusually high exposure, compared to the general population.

Water Quality :

Sodium Cyanide 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 cyanide, 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 cyanide (non-target and avian and mammalian mort alities) that has not already been reported to the Agency.9 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 cyanide.10 II. FACT SHEET

Background Information

• Sodium cyanide registration review case number: 8002

• PC Code: 074002 ; CAS # 143-33-97

• Sodium cyanide was first register ed in the United States in 1947

• A Reregistration Eligibility Deci sion (RED) was issued in 1994

• A Tolerance Reassessment Eligibility Decision (TRED) was issued in 2006

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

• There is one Special Local Needs (SLN) f ood/feed use registration under Section 24(C) for use as an insecticide; a nd there are 8 FIFRA Section 3 active product registrations for use as a predicide.

• A tolerance of 50 ppm is establishe d under 40 CFR §180.130 for residues of hydrogen cyanide resulting from use of sodium cyanide in/on fruit and citrus.

• 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 Food/Feed & Non-Food/Non-Feed Uses Considered in Registration Review Wo rk Planning – Sodium cyanide (074002) (July 6, 2009) in the sodium cyanide docket.

• Sodium cyanide is classified as a restricted use pesticide (RUP) that may only be applied by certified applicators for both pr edicide and insecticide uses.

• Sodium cyanide is registered for use to cont rol coyotes, red foxes, gray foxes and wild dogs that are: suspected of pr eying on livestock; suspected of preying on threatened or endangered species; or are vect ors of communicable diseases.

• As a predicide sodium cyanide is formulat ed as a powder enclosed in polyethylene capsules containing 88.78%- 91.06% active ingredient.

• Each capsule is loaded into a capsule holder, which is screwed onto the ejector mechanism of an M-44. The capsule holder is treated with a scent formulated to attract canids. When an animal tugs at the capsule holder, a spring-driven plunger ejects sodium cyanide powder into the animal’s mouth causing the death of the animal.

• Sodium cyanide is also registered as an insecticide for one Speci al Local Needs (SLN) registration that is used in California. As an insecticid e (SLN registration) sodium cyanide is used as a source of hydrocyanic gas for quarantine fumigation of surface pests

to control red scale on fresh market citrus bound for Arizona.

• The SLN end-use product is formulated as a granular containing 98% sodium cyanide as the active ingredient. It is applie d by professional applicators only.11 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 and sodium fluroacetate. EPA denied the request to susp end 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 th e environment under FIFRA and that the registrations meet the FIFRA eligibility standards.

• In August 2010 the Agency amended APHIS M-44 registrations with updated label language to add more clarity to the use restrictions established in 1994.

• EPA is currently working with the States to amend all FIFRA Section 3 registration

labels to reflect the rece ntly revised label language.

Ecological Risk Assessment Status

The following are key findings of the ecologi cal risk assessments conducted to support the registered uses of sodium cyanide. For a detailed discussion of previous ecological risk

assessments refer to the EFED Registration Review Problem Formulation for Sodium Cyanide (M-44) (September 20, 2010), which is located in the docket.

• The most recent ecological risk assessment was completed in 1994 in support of the sodium cyanide Reregistration E ligibility Decision (RED).

• The primary environmental concern identifie d in previous risk assessments was the potential risk for direct e ffects on non-target birds and mammals when the M-44 sodium cyanide devices are triggered and M-44 is inj ected into the non-targ et animal’s mouth.

• In the 1994 RED EPA concluded that the use of M-44 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 M-44 sodium cyanide registrations could affect several listed species . However, FWS determined that if certain reasonable and prudent alternat ives and measures were a dopted, 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 sodium cyanide. Fo r a detailed discussion of the human health risk12 assessment status refer to the Sodium cyanide. Human Health A ssessment Scoping Document in Support of Registration Review (September 8, 2010), which is located in the docket.

• The most recent human health risk assessmen t for the use of sodium cyanide as an insecticide to fumigate CA citrus bound fo r AZ was completed in 2006 in support of the Tolerance Reassessment Elig ibility Decision (TRED). The 2006 risk assessment addressed dietary and occupa tional exposures and risks.

• A human health risk assessment was conducte d in 1994 in support of the sodium cyanide Reregistration Eligibility Decision (RED ). The 1994 risk assessment addressed occupational exposure and risk from use of sodium cyanide as a predicide.

Hazard Characterization:

• All forms of cyanide are extremely acutely t oxic by oral, dermal and inhalation routes of exposures. Cyanides are weakly irritating to th e skin and eye. No data are available on sensitizing properties.

• Based on available literature studies, neurotoxity is a majo r effect that occurs across species from exposure to cyanide in its various forms. Data indicate that cyanide induces developmental effects only at doses or con centrations that are overtly toxic to the

maternal animals.

• There are no guideline studies and no av ailable open litera ture studies on the carcinogenic potential of cyanid e. However, due to the acute lethality of cyanide, a carcinogenic evaluation is considered unnecessary.

• There was no qualitative or quantitative increased susceptibility in postnatal offspring toxicity and there is a low de gree of concern for residual uncer tainties for pre and/or postnatal susceptibility. Therefore, the FQPA uncer tainty safety factor was reduced to 1X for sodium cyanide.

Dietary Risk:

• In EPA’s 2006 risk assessment, dietary risk (f ood) estimates from all registered sodium cyanide uses were below the Agency’s level of concern.

• Drinking water exposure was not quantitatively assessed because exposure is expected to be negligible based on available monitoring data.

Residential and Recreational Risk:

• There are no registered residen tial uses of sodium cyanide; therefore, residential exposure has not been previously assessed.13 Aggregate Risk:

• An aggregate exposure assessment has not b een previously conducted because it is believed that sodium cyanide does not result in residential or dri nking water exposure and dietary (food) exposure estimates are below the Agency’s level of concern.

Occupational Risk:

• Occupational risk associated w ith the use of sodium cyanid e in bait products was last assessed in February 1994 in support of th e RED. EPA concluded that there are no significant occupational applicat or exposure concerns and that post-application exposure

would be minimal to humans since label rest rictions effectively limit exposure.

• Occupational exposure to hydrogen cyanide, resu lting from the use of sodium cyanide to fumigate citrus was last a ssessed in 2006. Dermal exposures were not expected based on the limited use pattern and were therefor e not assessed. Inhalation exposures were assessed using monitoring data from fumigati ons conducted at the California facility. Based on this assessment, occupational exposur e from use of sodium cyanide as a citrus fumigant are not of concern.

Cumulative assessment:

• EPA does not have available data to determ ine whether sodium cyanide has a common mechanism of toxicity with other substan ces. EPA has not made a common mechanism of toxicity finding for sodium cyanide and any other substances and, sodium cyanide 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 sodium cyanide has a common mechanism of toxicity with other substances.

Incidents

• A preliminary review of the Ecological In cident Information System (EIIS) and the
Avian Monitoring Information System (AIMS) Database identified forty-five terrestrial
animal incidents, covering a period from 1983-2009. Three of these incidents are

classified as misuses of M- 44. The database records mortality for twenty-six birds,
fifteen dogs, ten wolves, three fox and two bear . No aquatic incident s or plant incidents
were reported in the EIIS database for M-44.

• An updated review of sodium cyanide human incident reports was prepared by consulting the OPP Incident Data System (IDS) a nd the Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health Sentinel Event Notification System for Occupa tional Risk-Pesticides. Six inci dents have been reported from 2002 to present; one major incident, four moderate incide nts, and one minor incident. The single major human incident occurred in 2003 when an adult male (18-64 years old) was recreating on the Bureau of Land Management property. The man14 brushed the top of a device accidentally and was subsequently exposed to product particles (on his face and chest). Blood tests confirmed exposure. The man stated that he

had been unable to work since this incident due to long term effects such as difficulty in breathing and weakness. Four moderate incide nts occurred when the product was ejected accidentally; the patients complained of ey e irritation. A minor case did not have any symptoms; he stated that he administered am yl nitrite immediately after exposure to the product.

Tolerances and International Harmonization

• A tolerance of 50 ppm has been esta blished under 40 CFR §180.130 for hydrogen cyanide residues on citrus fruit, which resultfrom the use of sodium cyanide for postharvest fumigation of citrus. Use of sodium cyanide as a fumigant is limited to citrus

treated in California bound for Arizona a nd not for international export. Codex maximum residue limits (MRLs) do not currently exist for hydrogen cyanide.

Data Call-In Status

• Generic data call-ins (GDCI) were i ssued in 1992 (GDCI-074002-17029), 1993 (GDCI074002-17373), and 2007 (GDCI-074002-26902). Data have been submitted and are currently being reviewed.

• A product specific data call-in (PDC I) was issued in 1994 (PDCI-074002-0099).

Labels

• Active Section 3 labels for Sodium cyanide can be obtained from the Pesticide Product Label System (PPLS) website: http://oaspub.epa.gov/pestlabl/ppls.home

.