2

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 RISK ASSESSMENTS ..................................................................... 6

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

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

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

References:

This document summarizes the Environmental Protection Agency's current position based on the 

following documents: 

1. Registration Review: Combined Problem Formulation 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 the Registration Review: Antimycin A. Carl Chen, et al. July 

20, 2015.

5. Standard Operating Practices for the Use of Fintrol® (Antimycin A) for Restoration of Native 

Fish Populations. National Park Service. U.S. Department of the Interior. November 2012. 

6. Fintrol® Fish Toxicant Kit (EPA Reg. No. 3096-2). Revised labeling to add links to the National 

Park Service Standard Operating Procedures. John Hebert. December 31, 2012. 

These and other supporting documents for the antimycin 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 the first public comment period for this registration 

review (docket number EPA-HQ-OPP-2015-0480). Antimycin A is a restricted-use piscicide, 

registered to restore aquatic habitats by killing non-native fish. It is also registered to selectively kill 

scaled fish in aquaculture facilities raising catfish. Antimycin A is formulated as a soluble concentrate, 

and sold as Fintrol® Fish Toxicant Kit, which contains antimycin 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 other hand-held sprayer. Use is limited to relatively 

secluded areas. There are no registered 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 completing 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 combined problem formulation and draft ecological 

risk assessment because there are no additional data requirements for registration review. The draft 

human health and ecological risk assessments and this Preliminary Work Plan (PWP) are now in the 

docket for a 60-day public comment period.

 

The registration review process was designed to include a public participation component to solicit 

input from interested stakeholders. The Agency intends, 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 decision 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-making process for this chemical. In addition to 

general areas on which persons may wish to comment, the PWP and Appendix identify areas for which 

the Agency specifically seeks comments and additional information. 

This PWP begins by addressing whether or when additional data will be required for antimycin A. It 

then summarizes the statutory and regulatory authority for registration 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 timeline for antimycin A. Finally, the appendix to this 

document includes identification and discussion of some areas that are considered generally in 

registration review along with some additional 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 limited to current registered uses for Fintrol®, the sole 

registered pesticide product containing antimycin A. However, EPA anticipates that substantial data 

would be necessary to support any new product 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 registered by EPA, 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 program is intended ensure 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 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 review each registered pesticide every 15 years to 

determine whether it continues to meet the FIFRA standard for registration. The regulations governing 

registration review are codified in 40 CFR 155.40. During registration review, EPA 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, data, or other 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 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 been 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 identified 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/ 
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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 Reregistration 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 piscicide (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 facilities to remove 

scaled fish from fingerling catfish ponds. 

Use Sites Antimycin A is registered for use in lakes, ponds, streams, and 

intermittently flooded areas. 

Summary of Usage No quantitative usage information 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 FIFRA 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 90th 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 technical or end use products 

containing antimycin A to the U.S. market. 

RECENT ACTIONS 

The antimycin A product label was amended in December 2012 to incorporate the 2012 National Park 

Service (NPS) Standard Operating Procedures, Standard Operating Practices for the Use of Fintrol®

(Antimycin A) for Restoration of Native Fish Populations. 

 
6

REGISTRATION REVIEW RISK ASSESSMENTS 

A combined registration review problem formulation for environmental fate and ecological effects and 

preliminary ecological risk assessment was completed on September 8, 2015. The draft human health 

risk assessment for antimycin A was completed on July 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 ecological 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 Environmental 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 limited areas in accordance 

with detailed standard operating procedures (SOPs) developed by the National Park Service (NPS), 

the existing database is adequate for purposes 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, antimycin A is very highly toxic to fish and aquatic 

invertebrates. At the maximum treatment concentration, acute risk quotients 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 deactivated before water leaves the targeted treatment 

area. In addition, bioassays using caged fish placed downstream from the treatment area confirm 

that antimycin A degrades/dissipates 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 with 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 macroinvertebrate populations in flowing water 

environments return to pretreatment levels within several months of treatment. 

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

 Use of antimycin A in aquaculture is limited to clearing catfish fingerling production ponds of 

scaled fish. These ponds are not drained until adult catfish 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 for the aquaculture use. 

 Although the environmental fate and effects database for antimycin A is limited, it is sufficient for 

this registration review. However, EPA anticipates that additional data would be necessary to 

evaluate any potential new uses. 
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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 antimycin A. As a restricted-use pesticide, 

antimycin A is applied only by trained and/or certified applicators wearing extensive personal 

protective equipment. Use restrictions and the chemical properties of antimycin A prevent residues 

from occurring in food commodities or drinking water. Access to treated areas is prohibited during 

treatment and for 7 days following treatment, thereby eliminating any potential bystander exposure. 

These use restrictions preclude human exposure or risk. 

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

additional data would be needed to evaluate any new uses. 

Table 3: Summary of the Draft Ecological 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 incidents have been reported for 

antimycin A. 

Human Health 

Dietary 

Food N There is no human dietary 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 registered 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 incidents have been reported for 

antimycin A. 
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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 already reported to the Agency. 

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

TIMELINE 

EPA has created the following estimated timeline 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 Period2,3 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 Decision for the registration review of 

antimycin A. 

 

 

2

 The Agency is seeking comment on this PWP and the draft human health and ecological 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 pesticides, the Agency plans to 

provide a 60 calendar day public comment period generally for draft risk assessments. 
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Appendix – Additional Areas Considered in the Antimycin A Registration Review 

PUBLIC COMMENTS AND FEEDBACK: 

Guidance for Commenters: The areas below highlight topics of special 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 impairment 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 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 Process7

 in order 

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

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 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 Interim Approaches for assessing risks to listed species from pesticides. 

The Interim Approaches were developed jointly by the agencies in response to the National Academy of 

Sciences’ (NAS) recommendations and reflect a common approach to risk assessment shared by the 

agencies as a way of addressing scientific differences 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_pollutant_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.htm
10

pesticide risk assessments that EPA and the Services must conduct in connection 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 addition, the EPA presented the joint Interim Approaches at the 

December 2013 Pesticide Program Dialogue Committee (PPDC) and State-FIFRA Issues Research and 

Evaluation Group (SFIREG) meetings, and held a stakeholder workshop 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 will also consider public comments 

on the Interim Approaches in connection with the development of upcoming Registration Review 

decisions. The details of the joint Interim Approaches are contained in the white paper “Interim 

Approaches for National-Level Pesticide Endangered Species Act Assessments Based on the 

Recommendations of the National Academy of Sciences April 2013 Report,” dated November 1, 2013. 

Given that the agencies are continuing to develop 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-target wildlife and plants that assumes for the 

sake of the assessment that listed species and designated 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 potential for effects exists once the scientific methods 

being developed by the agencies have been fully vetted. This screening-level risk assessment for 

antimycin A indicates potential risks of direct effects to listed freshwater and estuarine/marine fish and 

invertebrates. Once the agencies have fully developed and implemented the scientific methods necessary 

to complete risk assessments for endangered and threatened (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 numerous studies to assess potential adverse 

outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and 

chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, reproductive, 

and general or systemic toxicity. These studies include endpoints which may be susceptible to 

endocrine influence, including effects on endocrine target organ histopathology, organ weights, estrus 

cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, and sex ratios in 

offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess 

growth, developmental and reproductive effects in different taxonomic groups. As part of its most 

recent Reregistration Eligibility Decision for antimycin A, EPA reviewed these data and selected the 

most sensitive endpoints for relevant risk assessment 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 certain substances (including pesticide active and 
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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 endocrinerelated effects caused by the substance, and establish a dose-response relationship between the dose 

and the E, A, or T effect. 

Under FFDCA section 408(p), the Agency 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 ingredients and 9 inert ingredients. A second list of chemicals identified 

for EDSP screening was published on June 14, 20138

 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, the 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/