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### Antimycin A – Table of Contents

OVERVIEW ...................................................................................................................... .............. 3

DATA NEEDS .................................................................................................................... ............ 3

STATUTORY AND REGULATORY AUTHORITY ................................................................... 4

CHEMICAL FACTS ................................................................................................................ ....... 4

USE AND USAGE INFORMATION ............................................................................................. 5

RECENT ACTIONS ................................................................................................................ ....... 5

REGISTRATION REVIEW RI SK ASSESSMENTS ..................................................................... 6

TIMELINE ...................................................................................................................... ................ 8

NEXT STEPS .................................................................................................................... .............. 8

Appendix – Additional Areas Considered in the Antimycin A Registration Review.................9

References:

This document summarizes the Environmental Pr otection Agency's current position based on the following documents:

1. Registration Review: Combined Problem Formul ation for Preliminary Environmental Fate and Ecological Risk Assessment for Antimycin A. September 8, 2015.

2. Antimycin A. Human Health Assessment Scoping Document and Preliminary Human Health Risk Assessment in Support of Registration Review. July 6, 2015.

3. Antimycin A: Tier I Review of Human Incidents . Elizabeth Evans and Shanna Recore. April 15,

2015.

4. BEAD Chemical Profile (BCP) for th e Registration Review: Antimycin A . Carl Chen, et al . July 20, 2015.

5. Standard Operating Practices for the Use of Fint rol® (Antimycin A) for Restoration of Native Fish Populations . National Park Service. U.S. Departme nt of the Interior. November 2012.

6. Fintrol ® Fish Toxicant Kit (EPA Reg. No. 3096-2). R evised labeling to add links to the National Park Service Standard Operating Procedures. John Hebert. December 31, 2012.

These and other supporting documents for the antimy cin A registration review case may be found in the docket EPA-HQ-OPP-2015-0480 at http://www.regulations.gov

.3 OVERVIEW

The docket for antimycin A is now open, initiating th e first public comment period for this registration review (docket number EPA-HQ-OPP-2015-0480). Antim ycin A is a restricted-use piscicide, registered to restore aquatic habitats by killing non-nat ive fish. It is also regi stered to selectively kill scaled fish in aquaculture facilities raising catfish. Antimycin A is fo rmulated as a soluble concentrate,

and sold as Fintrol ® Fish Toxicant Kit, which contains an timycin A and a diluent containing the surfactant Nonoxynol-9. Fintrol ® is applied to water by a drip-feed device, which is part of a drip station, or by boat bailer, backpack sprayer or othe r hand-held sprayer. Use is limited to relatively secluded areas. There are no regist ered residential uses.

This document summarizes what the Environmental Protection Agency’s Office of Pesticide Programs knows about human health and ecological risks associated with the current registered uses of antimycin A and providing an anticipated timeline for completi ng the registration review for antimycin A.

Because there are no human health data needs and only minor updates were required to meet current assessment standards, EPA developed a combined scoping document and draft human health risk assessment. Likewise, the Agency developed a co mbined problem formulation and draft ecological

risk assessment because there are no additiona l data requirements for registration review. The draft human health and ecological risk assessments and th is Preliminary Work Plan (PWP) are now in the docket for a 60-day public comment period.

The registration review process wa s designed to include a public par ticipation component to solicit input from interested stakeholders. The Agency in tends, by sharing this information in the docket, to inform the public of what it knows about antimycin A and what types of information would be helpful for the Agency as it moves toward an interim registration review decisi on on antimycin A. The Agency encourages all interested stakeholders to (1) review the PWP, its appendix, and the associated draft human health and ecological risk assessments and (2) provide comments and additional information that will help the Agency’s decision-m aking process for this chemical. In addition to general areas on which persons may wish to commen t, the PWP and Appendix identify areas for which the Agency specifically seeks comments and additional information.

This PWP begins by addressing whether or when additi onal data will be required for antimycin A. It then summarizes the statutory a nd regulatory authority for registra tion review. In addition, the PWP provides chemical facts, use and usage information, recent actions, a summary of the draft risk assessments, and a projected registration review timelin e for antimycin A. Finally, the appendix to this

document includes identification a nd discussion of some areas that are considered generally in registration review along with some addi tional chemical case-specific information.

DATA NEEDS

The Agency does not plan to require any additional data for the registration review of antimycin A. The scope of this registration review is lim ited to current registered uses for Fintrol ® , the sole registered pesticide product contai ning antimycin A. However, EPA an ticipates that substantial data would be necessary to support any new produc t registrations or expansion of use.4 STATUTORY AND REGULATORY AUTHORITY

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All pesticides distributed or sold in the U.S. generally must be register ed by EPA, based on scientific data showing that they will not cause un reasonable risks to human health or the environment when used as directed on product labeling. The program is intended en 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. Informati on on this program is provided on EPA’s website. 1

The Agency is implementing the program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and will re view each registered pesticide every 15 years to

determine whether it continues to meet the FIFRA st andard for registration. The regulations governing registration review are codified in 40 CFR 155.4 0. During registration review, EPA will consider benefits information and data, as required by FIFRA. The public phase of re gistration review begins when the initial docket is opened fo r each case. The docket is the Agency’s opportunity to state what it knows about the pesticide and what additional risk an alyses, data, or other in formation it believes are needed to make a registration review decision. Af ter reviewing and responding to comments and data received in the docket during this initial comment period, the Agency will develop a proposed interim decision for antimycin A.

CHEMICAL FACTS

Table 1 provides a summary of the chemical facts for antimycin A.

Table 1: Chemical Facts for Antimycin A (Fintrol ® )

PC code 006314 Case Number Not applicable

CAS Number 1397-94-0 Year first registered 1960 Pesticide Type Piscicide

Chemical Class None Reregistration Eligibility Decision (RED) May 2007

Cumulative Group None

40 CFR Citation No tolerances have b een established for antimycin A. Dual-use Antimycin A is registered for conventional pesticidal uses only and has no registered antimicrobial or biopesticidal uses. Non-pesticidal Uses There are no identifi ed non-pesticidal uses of antimycin A.

Pesticide Re-evaluation Division, Chemical Review Manager Christina Scheltema, scheltema.christina@epa.gov, 703-308-2201

1 http://www.epa.gov/oppsrrd1/registration_review/5 Table 1: Chemical Facts for Antimycin A (Fintrol ® )

Registration Division, Product Manager Mark Suarez, Suarez.mark@epa.gov , 703-305-0120

USE AND USAGE INFORMATION

Table 2 summarizes the use and usage information for antimycin A. Please see the BEAD Chemical Profile (BCP) for Reregistrati on Review: Antimycin A (PC 006314) in the registration review docket

for more details.

Table 2: Antimycin A Use and Usage Information

Summary of Use Antimycin A is a piscicid e (fish toxicant) registered for use to

control unwanted fish. It is used by Federal and State resource management agencies for habitat restoration and by private sector certified pesticide applicators in aquaculture facili ties to remove scaled fish from fingerling catfish ponds. Use Sites Antimycin A is registered fo r use in lakes, ponds, streams, and intermittently flooded areas. Summary of Usage No quantitative usage in formation is available for antimycin A. Formulation Type(s) Soluble concentrate Application Method(s) Spray equipment, boat bailer, or drip stations. Technical Registrant(s) Aquabiotics Corporation No. of Registrations One FI FRA Section 3 registration

Restricted Use Yes

Guidance for Commenters: Additional areas of use and usage related information requested for this registration review, and of particular interest to EPA, are described below.

 Use distribution ( e.g. , geographical distribution of relevant use sites).

 Median and 90 th percentile reported use rates (lbs a.i./A ) from usage data – national, state, and
county.

 State or local use restrictions.

 Foreign technical registrants not listed above who supply te chnical or end use products containing antimycin A to the U.S. market.

RECENT ACTIONS

The antimycin A product label was amended in Decem ber 2012 to incorporate the 2012 National Park Service (NPS) Standard Operating Procedures, Standard Operating Practices for the Use of Fintrol ® (Antimycin A) for Restorati on of Native Fish Populations

.6 REGISTRATION REVIEW RISK ASSESSMENTS

A combined registration review pr oblem formulation for environmenta l fate and ecological effects and preliminary ecological risk assessment was comple ted on September 8, 2015. The draft human health risk assessment for antimycin A was completed on Ju ly 6, 2015. The previous ecological and human health risk assessments were completed in 2007 to support the Reregistration Eligibility Decision for antimycin A.

Conclusions of the preliminary eco logical and human health risk assessments for the registration review of antimycin A are summarized below. Table 3 summarizes aspects considered in these preliminary risk assessments. Please see the September 8, 2015 document, Registration Review: Combined Problem Formulation for Preliminary Envi ronmental Fate and Ecological Risk Assessment for Antimycin A and the July 6, 2015 document, Antimycin A – Draft Human Health Risk Assessment for Registration Review , for details.

Ecological Risk Summary

 Because antimycin A is a restricted-use pesticide, used in relatively limite d areas in accordance with detailed standard operating procedures (SOPs) developed by the National Park Service (NPS), the existing database is adequate for pur poses of registration review. The NPS Standard Operating Practices for the Use of Fintrol ® (Antimycin A) for Restoration of Native Fish Populations are now part of the federal pesticide label.

 Consistent with its intended use as a piscicide, antim ycin A is very highly toxic to fish and aquatic

invertebrates. At the maximum treatment concentr ation, acute risk quotient s within the treatment area exceed EPA’s levels of concern, based on the most sensitive species. However, when antimycin A is used in flowing water, it is deactiv ated before water leaves the targeted treatment area. In addition, bioassays using caged fish pl aced downstream from th e treatment area confirm that antimycin A degrades/dissipa tes below levels of concern.

 Given that use of antimycin A is intended to result in 100% kill of the target species when it is used to restore native fish populations in accordance w ith the NPS SOPs, and that it is deactivated so treated water does not move outside the targeted treatment area, EPA does not have concerns for chronic exposure or risk to either fish or aquatic invertebrates.

 Data provided by the NPS indicate that macroi nvertebrate populations in flowing water environments return to pretreatment levels within several months of treatment.

 Antimycin A is not expected to pose ri sks to fish-eating birds and mammals.

 Use of antimycin A in aquaculture is limited to clearing catfish finger ling production ponds of scaled fish. These ponds are not drained until adult ca tfish have been harvested at least a year after treatment. Shortly after treatment, antimycin A degrades without harming catfish. Therefore, EPA

does not have risk concerns fo r the aquaculture use.

 Although the environmental fate and effects database for antimycin A is limited, it is sufficient for this registration review. However, EPA anticipat es that additional data would be necessary to evaluate any potential new uses.7 Human Health Risk Summary

 EPA has conducted a qualitative human health risk assessment for antimycin A. At this time, the Agency has no human health risk concerns for an timycin A. As a restricted-use pesticide, antimycin A is applied only by trained and/or certified applicators wearing extensive personal protective equipment. Use restri ctions and the chemical propertie s of antimycin A prevent residues from occurring in food commodities or drinking water. Access to treated area s is prohibited during treatment and for 7 days following treatment, there by eliminating any potential bystander exposure. These use restrictions preclude human exposure or risk.

 The existing database is sufficient for this re gistration review; however, EPA anticipates that

additional data would be needed to evaluate any new uses.

Table 3: Summary of the Draft Ecologica l and Human Health Risk Assessments for the Antimycin A Registration Review

Type of Risk Assessment Conducted? Notes

Ecological and Environmental Fate Ecological and environmental fate

risk assessment Y The assessment is based on the existing database for antimycin A. Endangered Species Assessment N Please see pages 39 and 40 of the preliminary risk

assessment. Incidents Y No ecological in cidents have been reported for antimycin A.

Human Health Dietary

Food N There is no human dietar y exposure to antimycin A. Drinking water N Occupational Handlers (mixers, loaders, applicators) Y EPA has conducted a qualitative assessment.

Post-application N

Residential Handlers N There are no regist ered residential use products containing antimycin A. Post-application Y EPA has conducted a qualitative assessment.

Other Aggregate N Human exposure to antimycin A is minimal; therefore a quantitative aggregate assessment was not conducted. Cumulative N Antimycin A has not been identified as a member of a cumulative group that shares a common mechanism of toxicity.

Tolerances N No tolerances have been established for antimycin A. Incidents Y No human poisoning inci dents have been reported for antimycin A.8 Guidance for Commenters: Additional ecological information requested for this registration review, and of particular interest to EPA, is described below.

 Ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian and mammalian mortalities) not alr eady reported to the Agency.

 Water quality monitoring data (s ee Appendix for further details).

TIMELINE

EPA has created the following estimated time line for the antimycin A registration review.

Table 4: Projected Antimycin A Registration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and 60-day Public Comment Period 2,3 2015 – September

Close Public Comment Period 2015 – November Registration Review Decision 60-day Public Comment Period for Proposed Interim Registration Review Decision 2016 April – June

Interim Registration Review Decision and PostDecision Follow-up 2017

Total (years) 2

NEXT STEPS

After the 60-day public comment period closes, the Agency will review and respond to any comments received in a timely manner and then issue a Proposed Interim Decisi on for the registration review of antimycin A.

2 The Agency is seeking comment on this PWP and the draft human health and eco logical risk assessments during this comment period.

3 The regulations governing registration review generally require the Agency to provide a public comment period of at least 30 calendar days for draft risk assessments; see 40 CFR Part 155.53(c). For conventional pe sticides, the Agency plans to provide a 60 calendar day public comment period generally for draft risk assessments.9 

### Appendix – Additional Areas Considered in the Antimycin A Registration Review

PUBLIC COMMENTS AND FEEDBACK:

Guidance for Commenters: The areas below highlight topics of sp ecial interest to the Agency where your comments, data submissions, or reference to sources of additional information could be of particular use.

Water Quality:

Antimycin A is not identified as a cause of impairme nt for any water bodies listed as impaired under section 303(d) of the Clean Water Act. 4 In addition, no Total Maximum Daily Loads (TMDL) or water quality criteria have been developed for antimycin A. 5 More information on impaired water bodies and TMDLs can be found at the Agency’s website. 6 The Agency invites submission of water quality data for this pesticide. To the extent possible, data shoul d conform to the quality standards in Appendix A of the OPP Standard Operating Procedure: Inclus ion of Impaired Water Body and Other Water Quality Data in OPP’s Registration Re view Risk Assessment and Management Process 7 in order to ensure they can be used quantitatively or qualitatively in pesticide risk assessments.

Environmental Justice:

EPA seeks to achieve environmenta l justice, the fair tr eatment 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 othe r factors, may have atyp ical, unusually high exposure to antimycin A compared to the general population. Please comment if you are aware of any subpopulations that may have atypical, unusually high exposure compared to the general population.

ENDANGERED SPECIES:

In November 2013, the EPA, along with the U.S. Fish & Wildlife Service (USFWS ), the National Marine Fisheries Service (NMFS) (collectively, the Services), and the U.S. Department of Agriculture (USDA) released a summary of their joint In terim Approaches for assessing risks to listed species from pesticides. The Interim Approaches were develo ped jointly by the agencies in response to the National Academy of Sciences’ (NAS) recommendations and reflect a comm on approach to risk assessment shared by the agencies as a way of addressing scientific di fferences between the EPA and the Services. The NAS report outlines recommendations on specific scientific and technical issues related to the development of

4 http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885

5 http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_p ollutant_detail?p_pollutant_group_id=885&p_pollutant_group_

name=PESTICIDES

6 http://www.epa.gov/owow/tmdl/

7 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm10 pesticide risk assessments that EPA and the Services must conduct in connecti on with their obligations under the Endangered Species Act (ESA) and FIFRA.

The joint Interim Approaches were released prior to an ongoing series of stakeholder workshops, beginning in November 2013. In a ddition, the EPA presente d the joint Interim Approaches at the December 2013 Pesticide Program Dialogue Committee (P PDC) and State-FIFRA Issues Research and Evaluation Group (SFIREG) meeti ngs, and held a stakeholder wo rkshop in April 2014, allowing additional opportunities for stakeholders to comment on the Interim Approaches. As part of a phased, iterative process for developing the Interim Approaches, the agencies wi ll also consider public comments on the Interim Approaches in c onnection with the development of upcoming Registration Review decisions. The details of the joint Inte rim Approaches are contained in the white paper “ Interim Approaches for National-Level Pesticide Endange red Species Act Assessments Based on the Recommendations of the National Acade my of Sciences April 2013 Report ,” dated November 1, 2013.

Given that the agencies are continuing to devel op and work toward implementation of the Interim Approaches to assess the potential risks of pesticides to listed species and their designated critical habitat, this preliminary risk assessment for antimycin does not contain a complete ESA analysis that includes effects determinations for specific listed species or designated critical habitat. Although EPA has not yet completed effects determinations for specific species or habitats, for this preliminary assessment EPA conducted a screening-level assessment for all taxa of non-targ et wildlife and plants that assumes for the sake of the assessment that listed species and designate d critical habitats may be present in the vicinity of the application of antimycin A. This screening-level assessment will allow EPA to focus its future evaluations on the types of species where the potenti al for effects exists once the scientific methods being developed by the agencies have been fully vetted. This screening-le vel risk assessment for antimycin A indicates potential risks of direct effects to listed freshwat er and estuarine/marine fish and invertebrates. Once the agencies ha ve fully developed and implemented the scientific methods necessary to complete risk assessments for endangered and threat ened (listed) species and their designated critical habitats, these methods will be applied to subsequent analyses for antimycin A as part of completing this registration review.

ENDOCRINE DISRUPTOR SCREENING PROGRAM:

As required by FIFRA and FFDCA, EPA reviews num erous studies to asse ss potential adverse outcomes from exposure to chemicals. Collectiv ely, these studies includ e acute, subchronic and chronic toxicity, including assessmen ts of carcinogenicity, neurotoxicit y, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influence, including effects on endocrine ta rget organ histopathology, organ weights, estrus cyclicity, sexual maturation, fertil ity, pregnancy rates, reprod uctive loss, and sex ratios in offspring. For ecological hazard assessments, EPA ev aluates acute tests and ch ronic studies that assess growth, developmental and reproductive effects in different taxonomic groups. As part of its most recent Reregistration Eligibility Decision for antimyci n A, EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessme nt scenarios from the existing hazard database. However, as required by FFDCA section 408(p), antimycin A is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whether ce rtain substances (incl uding pesticid e active and11 other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or ot her such endocrine effects as th e Administrator may designate.” The EDSP employs a two-tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screeni ng 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 w ill determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testi ng is designed to identify any adverse endocrinerelated effects caused by the subs tance, and establish a dose-respons e relationship between the dose and the E, A, or T effect.

Under FFDCA section 408(p), the Agen cy must screen all pesticide chemicals. 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 ingred ients and 9 inert ingredients. A second list of chemicals identified for EDSP screening was published on June 14, 2013 8 and includes some pesticides scheduled for registration review and chemicals found in water

. Neither of these lists should be construed as a list of known or likely endocrine disruptors.

For further information on the status of the EDSP, th e policies and procedures, the lists of chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit the EPA website. 9

8 See http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0477-0074 for the final second list of

chemicals.

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