United States Prevention, Pesticides EPA 738-R-07-007
Environmental Protection and Toxic Substances May 2007
(7508P)
Reregistration
Eligibility Decision for
Antimycin A
-------
REREGISTRATION ELIGIBILITY
DECISION
for
Antimycin A
ListD
Case No. 4121
Approved by:
Peter Caulkins
Acting Director, Special Review and
Reregistration Division
?-
Date
Page 2 of34
-------
Table of Contents
I. Introduction 7
II. Chemical Overview 7
A. Regulatory History 8
B. Chemical Identification and Nomenclature 8
C. Use Profile 8
III. Summary of Risk Assessments 10
A. Human Health Risk Assessment 11
1. Toxicity Profile 11
2. Metabolites and Degradates 12
3. Human Exposure and Risk 12
B. Ecological Risk Assessment 13
1. Environmental Fate and Transport 13
2. Ecological Exposure and Risk 13
3. Ecological Incidents 16
4. Endangered Species 17
IV. Risk Management and Reregistration Eligibility Decisions 17
A. Determination of Reregistration Eligibility 17
B. Requirements for Reregistration 18
1. Risk Mitigation Measures 18
2. Product Label Amendments 19
3. Confidential Statement of Formula 20
C. Regulatory Rationale 20
1. Benefits and Alternatives 20
2. Human Health Risk 21
3. Ecological Risk 24
4. Endocrine Screening 24
V. What Registrants Need to Do 24
A. Manufacturing Use Products 25
B. End-Use Products 25
1. Product-Specific Data Requirements 25
2. Confidential Statement of Formula 25
3. Labeling for End-Use Products 26
Page 3 of 34
-------
Antimycin A Reregistration Eligibility Decision Team
Office of Pesticide Programs
Use, Biological, Economic, and Alternatives Analysis
Nicole Zinn
Monisha Kaul
Jenna Carter
Jihad Alsadek
Environmental Fate and Effects Risk Assessment
Thomas Steeger
Dirk Young
Elizabeth Behl
Health Effects Risk Assessment
Debbie Smegal
Byong-Han Chin
Chris Olinger
Mike Metzger
Registration Support
Dan Peacock
John Hebert
Risk Management
Lance Wormell
DirkHelder
Margaret Rice
Office of General Counsel
Erin Koch
United States Department of Agriculture
Ted Rogers
Page 4 of 34
-------
Glossary of Terms and Abbreviations
a.i. Active Ingredient
aPAD Acute Population Adjusted Dose
APHIS Animal and Plant Health Inspection Service
ARTF Agricultural Re-entry Task Force
BCF Bioconcentration Factor
CDC Centers for Disease Control
CDPR California Department of Pesticide Regulation
CFR Code of Federal Regulations
ChEI Cholinesterase Inhibition
CMBS Carbamate Market Basket Survey
cPAD Chronic Population Adjusted Dose
CSFII USDA Continuing Surveys for Food Intake by Individuals
CWS Community Water System
DCI Data Call-in
DEEM Dietary Exposure Evaluation Model
DL Double layer clothing {i.e., coveralls over SL}
DWLOC Drinking Water Level of Comparison
EC Emulsifiable Concentrate Formulation
EDSP Endocrine Disrupter Screening Program
EDSTAC Endocrine Disrupter Screening and Testing Advisory Committee
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an
environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
EXAMS Tier II Surface Water Computer Model
FDA Food and Drug Administration
FFDCA Federal Food, Drug, and Cosmetic Act
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FOB Functional Observation Battery
FQPA Food Quality Protection Act
FR Federal Register
GL With gloves
GPS Global Positioning System
HIARC Hazard Identification Assessment Review Committee
IDFS Incident Data System
IGR Insect Growth Regulator
IPM Integrated Pest Management
RED Reregistration Eligibility Decision
LADD Lifetime Average Daily Dose
LC50 Median Lethal Concentration. Statistically derived concentration of a substance expected to
cause death in 50% of test animals, usually expressed as the weight of substance per weight or
volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LCO Lawn Care Operator
LD50 Median Lethal Dose. Statistically derived single dose causing death in 50% of the test animals
when administered by the route indicated (oral, dermal, inhalation), expressed as a weight of
substance per unit weight of animal, e.g., mg/kg.
LOAEC Lowest Observed Adverse Effect Concentration
LOAEL Lowest Observed Adverse Effect Level
LOC Level of Concern
LOEC Lowest Observed Effect Concentration
mg/kg/day Milligram Per Kilogram Per Day
MOE Margin of Exposure
MP Manufacturing-Use Product
Page 5 of 34
-------
MRID Master Record Identification (number). EPA's system of recording and tracking studies
submitted.
MRL Maximum Residue Level
N/A Not Applicable
NASS National Agricultural Statistical Service
NAWQA USGS National Water Quality Assessment
NG No Gloves
NMFS National Marine Fisheries Service
NOAEC No Observed Adverse Effect Concentration
NOAEL No Observed Adverse Effect Level
NPIC National Pesticide Information Center
NR No respirator
OP Organophosphorus
OPP EPA Office of Pesticide Programs
ORETF Outdoor Residential Exposure Task Force
PAD Population Adjusted Dose
PCA Percent Crop Area
PDCI Product Specific Data Call-In
POP USDA Pesticide Data Program
PF10 Protections factor 10 respirator
PF5 Protection factor 5 respirator
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
PIS Primary Irritation Score
ppb Parts Per Billion (ug/L; micrograms per liter)
PPE Personal Protective Equipment
PRZM Pesticide Root Zone Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RPA Reasonable and Prudent Alternatives
RPM Reasonable and Prudent Measures
RQ Risk Quotient
RTU (Ready-to-use)
RUP Restricted Use Pesticide
SCI-GROW Tier I Ground Water Computer Model
SF Safety Factor
SL Single layer clothing
SLN Special Local Need (Registrations Under Section 24(c) of FIFRA)
STORET Storage and Retrieval
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TRAC Tolerance Reassessment Advisory Committee
TTRS Transferable Turf Residues
UF Uncertainty Factor
USDA United States Department of Agriculture
USFWS United States Fish and Wildlife Service
USGS United States Geological Survey
WPS Worker Protection Standard
Page 6 of 34
-------
I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in
1988 to accelerate the reregi strati on of products with active ingredients registered prior to
November 1, 1984, and amended again by the Food Quality Protection Act of 1996 (FQPA)
and the Pesticide Registration Improvement Act of 2003 (PRIA) to set time frames for the
issuance of Reregi strati on Eligibility Decisions. FIFRA calls for the development and
submission of data to support the reregi strati on of an active ingredient, as well as a review of
all data submitted to the U.S. Environmental Protection Agency (EPA or "the Agency").
Reregi strati on involves a thorough review of the scientific database underlying a pesticide's
registration. The purpose of the Agency's review is to reassess the potential hazards arising
from the currently registered uses of a pesticide, to determine the need for additional data on
health and environmental effects, and to determine whether or not the pesticide meets the "no
unreasonable adverse effects" criteria of FIFRA.
The Agency made its reregi strati on eligibility determination for antimycin A based on
the required data, the current guidelines for conducting acceptable studies to generate such
data, and published scientific literature. The Agency has found that currently registered
piscicidal (fish-kill) uses of antimycin A are eligible for reregi strati on provided the
requirements for reregi strati on identified in this reregi stration eligibility decision (RED) are
implemented.
This document consists of six sections: Section I contains the regulatory framework
for reregi strati on reassessment; Section II provides an overview of the chemical, including a
profile of its use and usage; Section III gives an overview of the human health and ecological
risk assessments; Section IV presents the Agency's reregi strati on eligibility and risk
management decisions; Section V summarizes label changes necessary to implement the risk
mitigation measures outlined in Section IV; and Section VI includes the appendices, related
supporting documents, and Data Call-In (DCI) information. The revised risk assessment
documents and related addenda are not included in this document, but are available in the
Public Docket at http://www.regulations.gov in docket number EPA-HQ-OPP-2006-1002.
II. Chemical Overview
Antimycin A, or 3-methylbutanoic acid 3[[3-(formylamino)-2-
hydroxylbenzoyl]amino]-8-hexyl-2,6-dimethyl-4,9-dioxo-l,5-dioxonan-7-yl ester, is a
Restricted Use Pesticide registered by EPA for piscicidal (fish kill) uses. Derived as a
fermentation product from Streptomyces mold, the chemical is applied directly to water to
renovate recreational fish populations and to remove scaled fish from catfish fingerling and
food-fish production ponds. Over the past decade antimycin A has been used by Federal and
state agencies to restore threatened/endangered (listed) fish to their native habitats. Although
once explored as a potential cancer treatment, there is no known use of antimycin A in
human medicine.
Page 7 of 34
-------
A. Regulatory History
Antimycin A was discovered in 1945 and was first registered as a fish toxicant in
1960. There is one registered product that contains antimycin A (Fintrol-® Concentrate,
EPA Registration Number 39096-2, Aquabiotics Corp.). This product is classified as a
Restricted Use Pesticide (RUP) due to aquatic toxicity and the need for highly specialized
applicator training.
Data call-ins were issued in 1993 and several required toxicology studies were
submitted. The technical registrant submitted waiver requests for the remaining requirements
and the Agency granted these requests based on low usage.
B. Chemical Identification and Nomenclature
PC Code:
Common name:
Chemical structure:
Molecular Formula:
IUPAC name:
Chemical Class:
CAS#
006314
Antimycin A
HdC
C28H40N209
3-methylbutanoic acid 3[[3-(formylamino)-2-
hydroxylbenzoyl]amino]-8-hexyl-2,6-dimethyl-4,9-dioxo-l,5-
dioxonan-7-yl ester
Nitrosalicylanilide
1397-94-0
C. Use Profile
Antimycin A has two broad uses as a piscicide: fish management program use and
aquaculture use. Environmental factors such as water body size, pH, temperature, and, in
lotic environments, flow rate and gradient affect the amount of antimycin A and number of
application sites/stations that must be used to achieve the desired concentration. For
example, antimycin A is more effective in warm water; thus, less antimycin A may be
required during the summer months than the winter months for the same treatment site,
assuming other factors remain constant.
Fish Management Program Use
As part of a fish management program, antimycin A is used primarily by Federal and
state agencies to eliminate invasive or non-native species in an area where threatened or
indigenous species would later be restored. The compound is applied to water to achieve
Page 8 of 34
-------
treatment concentrations up to 25 parts per billion (ppb) by a drip-feed device which is part
of a drip station (see Figure 1), or by backpack sprayer, boat bailer, or other hand-held
sprayer. Drip stations are typically used in streams and rivers inaccessible to boat traffic.
Backpack sprayers may be used to supplement drip stations or other application devices in
areas with poor water circulation (e.g., stagnant pools that the chemical may not reach
through natural stream flow). Backpack sprayers are used in areas where water depth is 1
foot or less. Boat bailers are used in larger water bodies such as ponds and rivers. Deeper
water bodies may require the use of a pump mechanism (to ensure adequate mixing
throughout the water column) where antimycin A is dispensed through a perforated hose
stretching the length of the water column, or is delivered through the boat's propeller wash
using a pump mechanism.
Figure 1: Antimycin A Drip Station
5-gallon bucket containing water,
^ antimycin A & diluent, nonoxyl-9
Hose
Drip-feed device calibrated to
deliver 1 gallon per hour
Aquaculture Use
In aquaculture (catfish production), antimycin A can be applied at concentrations up
to 25 ppb to achieve a "complete kill" or at concentrations up to 10 ppb to achieve a
"selective kill." Complete kills are performed prior to stocking fmgerlings to eliminate all
fish in the treatment area. Selective kills are performed after stocking fmgerlings to
eliminate only smaller or more sensitive species that compete for food and resources and may
reduce the yields of commercial farmers. Approximately 18 to 36 months elapse before
fmgerlings weighing <50 grams (g) are harvested as adult catfish weighing >450 g.
Use Profile Summary
Type of Pesticide:
Summary of Use:
Piscicide.
Antimycin A is applied directly to water to manage fish
populations in lakes, ponds, reservoirs, rivers, streams, and in
Page 9 of 34
-------
Target Organisms:
Mode of Action:
Tolerances:
Use Classification:
Formulation:
Methods of Application:
Use rates:
Application Timing:
Annual usage:
aquaculture. The chemical can be applied at high
concentrations to achieve a "complete kill" or, in aquaculture
only, at lower concentrations to achieve a "selective kill."
Complete kills are used to eliminate all fish in the treatment
area; selective kills are used to eliminate only smaller or more
sensitive species.
Undesired fish species.
Antimycin A uncouples oxidative phosphorylation by blocking
the electron transport pathway to Complex III within the
mitochondria.
No tolerance exists for antimycin A.
The Antimycin A product is classified as a Restricted Use
Pesticide due to aquatic toxicity and the need for highly
specialized applicator training.
Liquid.
Applications are made with a drip-feed device as part of a drip
station, backpack sprayer, boat bailer, and sprayer.
The label evaluated in this RED for the sole product containing
antimycin A allows the chemical to be applied to achieve
treatment concentrations up to 25 parts per billion (ppb) and
recommends 7 to 10 ppb for use in aquaculture.
Antimycin A may be applied at any time of year.
Available usage data for piscicidal applications indicate that
several hundred pounds of antimycin A are applied annually.
III. Summary of Risk Assessments
This section summarizes EPA's human health and ecological risk conclusions for
antimycin A to help the reader better understand EPA's risk management decisions. The full
risk assessments and related supporting documents are available at
http://www.regulations.gov in docket number EPA-HQ-OPP-2006-1002. EPA's human
health and ecological risk assessments were updated based on comments received during the
60-day public comment period that closed on March 19, 2007.
Comments were received from Aquabiotics Corp., National Park Service, Food &
Water Watch, Trout Unlimited, Wyoming Game and Fish Department, State of Arizona
Game and Fish Department, American Fisheries Society Task Force on Fishery Chemicals,
Page 10 of 34
-------
Turner Enterprises, People for the Ethical Treatment of Animals, Colorado Division of
Wildlife, Wilderness Watch, and several citizens. In addition to other comments,
respondents expressed interest in reviewing the proposed standard operating procedures
manual, the necessity of preventing human exposure, concerns with the relatively sparse
human health and ecological database, and suggested risk reduction strategies. The Agency's
response to comments documents are available in the antimycin A public docket and this
RED presents risk management decisions based on public input.
Where possible, EPA relied on maximum labeled application concentrations to
estimate exposure in its human health and ecological risk assessments. The antimycin A
label evaluated in EPA's assessments allows treatment concentrations up to 25 ppb for
difficult-to-control species but does not specify a maximum treatment concentration. Based
on communications with stakeholders and users, EPA believes that treatment concentrations
of 25 ppb or lower are suitable to control unwanted fish species and that higher
concentrations may result in additional and unnecessary risk. As a result of this RED, labels
will be amended to specify a maximum treatment concentration of 25 ppb (see Section IV).
A. Human Health Risk Assessment
Because relatively few data are available, EPA did not conduct a quantitative human
health risk assessment for antimycin A. EPA evaluated the submitted data as well as
available open literature and determined that there is adequate information to support a
reregi strati on eligibility decision for the limited piscicidal uses, provided labeling is
implemented that will eliminate or virtually eliminate the potential for human exposure.
1. Toxicity Profile
Toxicity assessments estimate to what degree a pesticide could cause adverse health
effects in humans and the level or dose at which such effects could occur.
a) Acute Toxicity Profile
Table 1 presents available information on the acute toxicity for the one registered
end-use pesticide product containing antimycin A (Fintrol®, 23% active ingredient). Waiver
requests have been granted for the remaining data requirements due to low and specialized
use patterns. In cases where data were not available, EPA made reasonable worst-case
toxicity assumptions. The Agency may modify its conclusions or assumptions upon
submission of additional data.
Table 1. Acute Toxicity Profile of Fintrol®
Guideline
Number
870.1100
Study Title
End-use acute oral [rat]
Source
(MRID)
45937201
Results
LD50 = 286 mg/kg (M)
LD50 = 361 mg/kg (F)
LD50 = 316 mg/kg (combined)
Toxicity
Category
II
Page 11 of 34
-------
Guideline
Number
870.1200
870.1300
870.2400
870.2500
870.2600
Study Title
Acute dermal [rat]
Acute inhalation [rat]
Acute eye irritation
[rabbit]
Acute dermal irritation
Skin sensitization
Source
(MRID)
46762604
46762605
46762603
46762602
N/A
Results
LD50 >5000 mg/kg
LC50 = >2.59 mg/L
From 24 hours to 14 days, 1/2
had scattered diffuse areas of
opacity
Not a dermal irritant
Not a dermal sensitizer
Toxicity
Category
IV
IV
II
N/A
N/A
LD50 = Median Lethal Dose; N/A = not applicable
b) Completeness of Database
The toxicological database for antimycin A is inadequate to conduct a quantitative
risk assessment. However, EPA believes that the available submitted data as well as
available open literature studies are adequate to support a reregi strati on eligibility decision,
provided labeling is implemented that will eliminate or virtually eliminate the potential for
human exposure.
2. Metabolites and Degradates
EPA reviewed the metabolism of antimycin A and concluded that there are
degradation products. EPA believes that degradation products would not likely present risks
above the Agency's level of concern, provided labeling is implemented that will eliminate or
virtually eliminate the potential for human exposure.
3. Human Exposure and Risk
In the absence of data demonstrating exposure and risk below the Agency's level of
concern, exposure to antimycin A must be virtually eliminated to be eligible for
reregi strati on. Dietary exposure to antimycin A may occur by consuming treated water or
fish. Recreational exposure may occur by swimming, wading, fishing, or performing other
recreational activities in treated water. Occupational exposure may occur by mixing,
loading, applying, or otherwise directly participating in an antimycin A application.
To preclude human exposure, labels must be amended to prohibit harvesting of
surviving fish from a selective kill use for 12 months after treatment; require drinking water
intakes within the treatment area to be closed until monitoring samples demonstrate
antimycin A levels are below the limit of detection (0.015 ppb); prohibit public access to the
treatment area during and for 7 days after treatment (i.e., after >99% degradation assuming
tl/2= 12 hours); require outflow from treated areas to be deactivated with potassium
permanganate; require additional personal protective equipment (PPE) for handlers. In
addition, the registrant must submit a detailed standard operating procedures (SOP) manual
(see Section IV).
Page 12 of 34
-------
These measures will be incorporated in the product labeling. Certain label
restrictions may be reduced or removed upon submission of acceptable toxicity and exposure
studies that demonstrate risk would not exceed the Agency's level of concern.
B. Ecological Risk Assessment
EPA conducted an ecological risk assessment for antimycin A to support the
reregi strati on eligibility decision. EPA evaluated the submitted environmental fate and
ecological studies as well as available open literature and determined that the data are
adequate to support a reregi strati on eligibility decision.
1. Environmental Fate and Transport
Although environmental fate data are limited, the primary route of degradation
appears to be base hydrolysis. In studies conducted by EPA, antimycin A degraded relatively
rapidly (tl/2 < 12 hours, pH 1 to 9) under static conditions. Half-lives for antimycin A tended
to decrease with increasing pH and under more alkaline conditions (pH 9) the average half-
life due to hydrolysis was 3.4 hours. In studies where the test solutions were mechanically
mixed rather than static, half-lives at environmentally relevant pH values (pH 5 to 8) ranged
from less than 1 hour to 10 hours.
Field data indicating that antimycin A can move considerable distances (1.75 km) are
not inconsistent with measured hydrolysis rates since the flow rate of treated stream water in
these studies was such the chemical could move over a kilometer in less than 12 hours.
However, the hydrolysis data and field data are inconsistent with chemical half-lives
estimated using a registrant-submitted aerobic metabolism study. It is uncertain why
laboratory data indicate that antimycin A is subject to rapid hydrolysis whereas the aerobic
metabolism study indicates otherwise. It is possible that sediment-water systems, such as
that used in the aerobic metabolism study, may provide a substrate for antimycin A sorption
and that the sediment may shield antimycin A from hydrolytic degradation. However,
antimycin A that is bound to sediment is not expected to be bioavailable and any amount of
compound that may desorb is expected to degrade rapidly given the short half-life.
Based on model estimates, antimycin A is not expected to be mobile in soil and
sediment (log Koc = 3.41) and has a relatively low potential for bioconcentrating in aquatic
organisms (bioconcentration factor = 350x). A compound is considered likely to
bioconcentrate if the bioconcentration factor (BCF) is >1000. Models indicate that
antimycin A is not likely to persist in the environment and its low vapor pressure (2.3 IxlO"15
mm Hg) and Henry's Law constant (2.42 xlO"17 atm-m3 mol"1) limit its volatility.
2. Ecological Exposure and Risk
To estimate potential ecological risk, EPA integrates the results of exposure and
ecotoxicity information using the risk quotient (RQ) method. RQs are calculated by dividing
acute and chronic estimated environmental concentrations (EEC) by ecotoxicity values for
Page 13 of 34
-------
various wildlife and plant species. RQs are then compared to the levels of concern (LOG)
presented in Table 2.
Table 2. EPA's Levels of Concern for Risk Quotients
Risk Presumption
Acute Risk - there is potential for acute risk
Acute Endangered Species - endangered species
may be adversely affected1
Chronic Risk - there is potential for chronic risk
Level of Concern
Terrestrial
Animals
0.5
0.1
1
Aquatic
Animals
0.5
0.05
1
Plants
1
1
N/A
1 RQs that exceed EPA's level of concern for endangered species do not constitute a "may affect finding" under
the Endangered Species Act.
When the RQ exceeds the level of concern for a particular category, the Agency
presumes a risk of concern. In general, the higher the RQ, the greater the potential risk. Risk
characterization provides further information on potential adverse effects and the possible
impact of those effects by considering the fate of the chemical and its degradates in the
environment, organisms potentially at risk, and the nature of the effects observed.
a) Aquatic Organisms
EPA estimated toxicity, exposure, and risk to freshwater fish and invertebrates. Data
were not available to evaluate the risk of antimycin A exposure to non-target aquatic plants.
To estimate risks to aquatic animals, the Agency considered estimated environmental
concentrations (EEC) in surface water bodies based on a treatment concentration of 25 ppb.
Table 3 presents a summary of potential ecological risk from exposure to antimycin A.
Table 3. Summary of Potential Risk to Aquatic Organisms
Taxonomic Group1
Freshwater Fish
Freshwater Invertebrates
Saltwater Mollusk
Direct Acute Effects
Mortality
Mortality, immobilization
Mortality
RQ
2,778
3,125
0.40
1 Data were not available for aquatic plants.
Freshwater Fish
As a registered piscicide, antimycin A is expected to kill fish and aquatic
invertebrates at the concentrations at which it is applied. Based on the most sensitive species
and treatment concentrations of 25 ppb, acute risk levels of concern are exceeded for aquatic
animals by several orders of magnitude. Even for the least sensitive fish and aquatic
Page 14 of 34
-------
invertebrates tested, treatment concentrations of 25 ppb would exceed acute risk levels of
concern.
Adequate data are not available to quantitatively estimate chronic risk to aquatic or
terrestrial animals. However, available data indicate that antimycin A will not persist in the
environment; would, in flowing waters, eventually be flushed through the system and would
be diluted by untreated tributaries; and is typically only applied to an area once per year.
Thus, the likelihood of chronic ecological exposure is low. To ensure chronic exposure does
not occur, the Agency will require outflow from treatment areas to be deactivated with
potassium permanganate (see Section IV).
Where antimycin A is used to remove scaled fish from aquaculture ponds, treatment
concentrations are considerably lower than 25 ppb to ensure that the health/survival of the
crop is not impaired. Therefore, the likelihood of either acute or chronic effects in non-target
animals from the use of antimycin in aquaculture is low, particularly since the treated water
is typically retained within the aquaculture facility. The extent to which treated water is
released into adjacent water bodies is uncertain as are the associated risks to non-target
aquatic animals. Therefore, to preclude exposure to non-target aquatic animals, outflow of
treated water from aquaculture ponds must be deactivated with potassium permanganate (see
Section IV). Potassium permanganate is a strong oxidizing agent with a variety of uses
including deactivating piscicides such as antimycin A and purifying drinking water for
human consumption.
Freshwater Invertebrates
Based on laboratory data, aquatic invertebrates and fish appear to demonstrate
comparable sensitivity to antimycin A. However, field studies in high-gradient mountain
streams deactivated with potassium permanganate suggest that aquatic invertebrate
populations are temporarily affected by antimycin A. Sampling conducted several months to
a year after treatment indicate that aquatic invertebrate abundance and diversity were similar
to pretreatment levels. Even in first-order streams where antimycin A was not deactivated
with potassium permanganate, invertebrate drift and survival did not appear to be
significantly affected during or immediately after 8-hr treatments at 10 ppb. Whether these
studies are indicative of aquatic invertebrate communities in all antimycin A use areas is
uncertain. To address the uncertainly of whether these studies are indicative of aquatic
invertebrate communities in general, the standard operating procedures manual required by
this RED will include, as part of the required final report, a discussion of the pre- and post-
treatment monitoring results for non-target organisms within the treatment area (see Section
IV).
b) Terrestrial Organisms
EPA estimated toxicity, exposure, and risk to avian and mammalian terrestrial
organisms. Data were not available to evaluate the risk of antimycin A exposure to non-
target insects or terrestrial plants; however, given the ways in which antimycin A is applied,
exposure is expected to be minimal. To estimate risks to terrestrial animals, the Agency
Page 15 of 34
-------
considered EECs in surface water bodies based on a treatment concentration of 25 ppb.
Table 4 presents a summary of potential ecological risk from exposure to antimycin A. The
estimated risks to evaluated terrestrial organisms are below the Agency's level of concern.
Table 4. Summary of Potential Risk to Terrestrial Organisms
Taxonomic Group1
Birds
Mammals
Direct Acute Effects
Mortality, sub-lethal
Mortality
RQ2
<0.01
<0.01
1 Data were not available for insects or terrestrial plants.
2 Dose-based values.
Birds
Based on an acute oral toxicity study using formulated product, antimycin A is
classified as very highly toxic to water fowl (mallard duck LD50 = 2.9 mg/kg body weight)
and highly toxic to upland game birds (bobwhite quail LD50 = 39 mg/kg body weight).
However, since antimycin A is applied directly to water, there is little likelihood that
terrestrial forage items for birds will contain antimycin A residues from this use. While it is
possible that some piscivorous birds may feed opportunistically on dead or dying fish located
on the surface of treated waters, amended labels will recommend that dead fish be collected
and buried, rendering the fish less available for consumption (see Section IV). In addition
many of the dead fish, given sufficient time, will sink and will not be available for
consumption by birds.
Mammals
Based on an acute oral toxicity study using formulated product, antimycin A is
classified as moderately toxic to mammals following acute oral exposure (male rat LD50 =
286 mg/kg, female rat LDso = 361 mg/kg). However, antimycin A is not likely to present
significant food exposure to wild mammals because treatments are typically conducted in an
area no more than once per year and dead fish, given sufficient time, will tend to bloat and
sink below the surface of the water where they disintegrate and will not available for
terrestrial animal consumption. Antimycin A is not likely to present significant drinking
water exposure to wild mammals because human presence will temporarily drive away
wildlife and the compound will rapidly degrade (standing and flowing water), become
diluted (flowing water), and, after deactivation with potassium permanganate, move beyond
(flowing water) treatment areas.
3. Ecological Incidents
A review of the Ecological Incident Information System database revealed no
reported incidents related to the use of antimycin A. However, because an incident has not
been formally reported does not necessarily indicate that incidents have not occurred. The
relatively low annual usage of antimycin A may partially explain the lack of reported
incidents.
Page 16 of 34
-------
4. Endangered Species
The Endangered Species Act required federal agencies to ensure that their actions are
not likely to jeopardize listed species or adversely modify designated critical habitat. A
primary use of antimycin A is to eliminate invasive or non-native species in designated
critical habitat so threatened or indigenous species may later be restored.
The Agency has developed the Endangered Species Protection Program to identify
pesticides whose use may cause adverse impacts on federally listed endangered and
threatened species, and to implement mitigation measures that address these impacts. To
assess the potential of registered pesticide uses that may affect any particular species, EPA
puts basic toxicity and exposure data developed for the REDs into context for individual
listed species and considers ecological parameters, pesticide use information, the geographic
relationship between specific pesticide uses and species locations and biological
requirements and behavioral aspects of the particular species. When conducted, these
analyses take into consideration any regulatory changes recommended in the RED being
implemented at that time. A determination that there is a likelihood of potential effects to a
listed species may result in limitations on the use of the pesticide, other measures to mitigate
any potential effects, and/or consultations with the Fish and Wildlife Service or National
Marine Fisheries Service, as necessary. If the Agency determines use of antimycin A "may
affect" listed species or their designated critical habitat, EPA will employ the provisions in
the Services regulations (50 CFRPart 402).
The ecological assessment that EPA conducted for this RED does not, in itself,
constitute a determination as to whether specific species or critical habitat may be harmed by
the pesticide. Rather, this assessment serves as a screen to determine the need for any
species specific assessment that will evaluate whether exposure may be at levels that could
cause harm to specific listed species and their critical habitat. That assessment would refine
the screening-level assessment to take into account such things as the geographic area of
pesticide use in relation to the listed species, the habits and habitat requirements of the listed
species, etc. If the Agency's specific assessments for antimycin A result in the need to
modify use of the pesticide, any geographically specific changes to the pesticide's
registration will be implemented through the process described in the Agency's Federal
Register Notice (54 FR 27984) regarding implementation of the Endangered Species
Protection Program.
IV. Risk Management and Reregistration Eligibility Decisions
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA) calls for the Agency to determine, after submission of relevant data concerning an
active ingredient, whether pesticides containing the active ingredient are eligible for
reregi strati on. Based on available data, EPA has completed its assessment of the risks
associated with the use of pesticides containing the active ingredient antimycin A and has
Page 17 of 34
-------
concluded that it has sufficient information to make a decision as part of the reregi strati on
process under FIFRA, as amended by the Food Quality Protection Act (FQPA).
EPA has determined that currently registered uses of antimycin A will not pose
unreasonable risks to humans or the environment if the requirements for reregi strati on
outlined in this document are implemented. Unless labeled and used as specified in this
document, antimycin A would present risks inconsistent with FIFRA. Accordingly, should a
registrant fail to implement any of the requirements for reregi strati on identified in this
document, the Agency may take regulatory action to address the potential risk concerns from
the use of antimycin A.
B. Requirements for Reregistration
Piscicidal uses for antimycin A are eligible for reregi strati on provided that registrant
complies with the requirements outlined in this document including the following: (1)
implement risk mitigation measures; (2) amend product labels; and (3) submit an up-to-date
confidential statement of formula (CSF) for each product.
1. Risk Mitigation Measures
Products containing antimycin A are eligible for reregi strati on provided that the
registrant implements the risk mitigation measures presented in Table 5. Specific labeling
requirements to implement these measures are presented in Table 6.
Table 5. Risk Mitigation Measures for Antimycin A
Risk of Concern
Exposure from
consuming treated
water may pose risks
of concern
Mitigation Measures
Flowing water (including outflow from standing water such as
lakes and aquaculture ponds) from treatment areas must be
deactivated with potassium permanganate.
Drinking water intakes within the treatment area must be closed
during treatment and until monitoring samples demonstrate
antimycin A levels are below the limit of detection (0.015 ppb).
Exposure from
consuming treated fish
may pose risks of
concern
Through posting and access area closures, the Certified
Applicator or designee under his/her direct supervision must
prohibit consumption of dead fish taken from treatment areas.
The registrant must amend labels to specify maximum treatment
concentrations of 10 ppb for use as a 'selective kill' in
aquaculture.
When antimycin A is applied as a selective kill in aquaculture,
the Certified Applicator must inform the owner/operator of the
aquaculture site being treated that surviving fish must not be
harvested for food or feed for a minimum of 12 months after
treatment.1
When antimycin A is applied as a complete kill in aquaculture,
the Certified Applicator must inform the owner/operator of the
aquaculture site being treated that the water body must not be
restocked for a minimum of 7 days after treatment.
Page 18 of 34
-------
Exposure from
performing
recreational activities
in treated water may
pose risks of concern
Through posting and access area closures, the Certified
Applicator or designee under his/her direct supervision must
prohibit recreational access (e.g., wading, swimming, boating
and fishing) to the treatment area during treatment and for 7
days after treatment.
Occupational exposure
may pose risks of
concern
The registrant must amend labels to specify maximum treatment
concentrations of 25 parts per billion (ppb).
The registrant must amend labels to require antimycin A
applications to be supervised by an on-site Certified Applicator.
The on-site Certified Applicator should attend a certification
program for piscicide applications.
The registrant must amend labels to require all mixers/loaders
and others exposed to the concentrate (e.g., through cleaning
equipment) to wear long-sleeved shirt and long pants, chemical-
resistant gloves, shoes plus socks, protective eyewear, a
dust/mist respirator, and a chemical-resistant apron.
The registrant must amend labels to require all applicators and
other handlers to wear long-sleeved shirt and long pants,
chemical-resistant gloves, shoes plus socks, and protective
eyewear.
In addition, applicators using handheld equipment or handheld
nozzles must wear a dust/mist respirator and coveralls.
The registrant must amend labels to prohibit handlers from
wearing contact lenses while handling this product.
Ecological risk
quotients (RQ) for
non-target species
exceed OPP's level of
concern
The registrant must amend labels to prohibit antimycin A use in
estuarine/marine environments.
Through deactivation with potassium permanganate, the
Certified Applicator or designee under his/her direct supervision
must ensure that antimycin A will not affect areas beyond the
treatment area.
The Certified Applicator or designee under his/her direct
supervision should collect and bury dead fish.
1 The registrant may request that EPA remove or reduce this restriction upon submission of acceptable toxicity
and exposure studies that demonstrate risk from consuming fish is below OPP's level of concern
2. Product Label Amendments
Manufacturing-Use Products and End-Use Products must be amended to reflect the
mitigation measures presented in Table 5 and the label amendments presented in Table 6 and
Table 7 (see Section V). As a result of this RED, the registrant will also be required to
develop and submit a standard operating procedures (SOP) manual that will be part of the
product labeling.
EPA believes that a detailed SOP manual is necessary for antimycin A because the
ways in which it is applied are significantly more complex than typical agricultural
pesticides. Because so many detailed instructions and procedures must be followed to
conduct a safe, effective, and lawful piscicide application, the product label may need to be
augmented to capture all of the necessary SOPs.
Page 19 of 34
-------
In addition to other topics and information, the antimycin A SOP manual must
contain detailed procedures/instructions for completing potentially complex activities
including, but not limited to, the following topics: planning an antimycin A application;
applying antimycin A as a complete and selective kill treatment; deactivating antimycin A
with potassium permanganate; virtually eliminating human (handler, bystander, dietary,
recreational) exposure; minimizing ecological exposure; documenting pre- and post-
treatment non-target populations; keeping treatment records; posting and preventing access to
treated areas; and facilitating compliance with the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), the Clean Water Act (CWA), the National Environmental Policy
Act (NEPA), and the Endangered Species Act (ESA).
The SOP manual is currently under development and the registrant will continue to
seek input from EPA for developing the draft SOP manual. The manual will be released for
public and stakeholder comment prior to finalization. The registrant will be responsible for
updating the manual as necessary and also for making it available to antimycin A users as
part of the required labeling.
3. Confidential Statement of Formula
Certain inert ingredients or impurities in the end-use product (Fintrol®) may pose
risks to human health and the environment. As part of product reregi strati on, the registrant
must submit an updated confidential statement of formula (CSF). The CSF must quantify all
inert ingredients and impurities >0.1%. If appropriate, EPA will take additional steps to
address risks of concern from inert ingredients and impurities (see 40 CFR 158.155).
C. Regulatory Rationale
The Agency has determined that antimycin A is eligible for reregi strati on provided
that the registrant implements the mitigation measures in this RED through amended
labeling. With amended labeling, EPA believes that antimycin A will not present risks
inconsistent with FIFRA and that the benefits of antimycin A to society - including enhanced
recreational areas and control of non-native and invasive species - outweigh the remaining
risks. A summary of EPA's rationale for reregistering and managing risks associated with
antimycin A is presented below.
1. Benefits and Alternatives
Antimycin A and rotenone (CAS Number 83-79-4, EPA PC Code 071003) are the
only two broad spectrum piscicides registered in the United States. Antimycin A and
rotenone each appear to have niche uses, although both can be applied in a variety of
situations. In general, antimycin A is used to repopulate native, threatened, or endangered
trout species in streams, by eliminating nonnative fish species, particularly in high-altitude
alpine lakes and streams because it is effective in cold alpine waters and where pH is low. In
addition, this piscicide may be used at low concentrations, which makes it easy to transport
to isolated or hard to reach mountain streams. Rotenone is most often used in standing water,
such as large lakes and reservoirs. It is typically applied to improve or maintain sport
Page 20 of 34
-------
fisheries, to sample fish populations, and to eliminate unwanted species in rearing ponds.
The costs of rotenone and antimycin A are similar. For sampling fish populations,
alternatives such as electrofishing are available. Electrofishing requires the use of
specialized equipment that runs a low-voltage current through the water to temporarily stun
fish for easy collection. However, for water bodies requiring partial or complete kill of
certain fish species, rotenone and antimycin A are more effective. Dewatering is an effective
alternative for complete kill in a water body. In select cases, gill netting, which generally
only reduces fish populations, has been used to remove fish from certain mountain lakes in
California.
Although some uses of rotenone and antimycin A coincide, they are not direct
replacements for each other. Because there are no other broad spectrum piscicides available,
the only possible alternatives are non-chemical fish control methods, and none are applicable
for all uses of rotenone or antimycin A. In situations where dewatering or electrofishing are
potential replacements, it is not clear if these are more cost effective or less detrimental to the
environment.
Because there are niche uses and no direct replacements available for all piscicidal
uses of antimycin A, EPA concludes that continued registration, subject to the requirements
of this RED, would provide benefit to society in controlling invasive or unwanted fish
species.
2. Human Health Risk
Adequate data were not available to conduct quantitative assessments to estimate
dietary, recreational, and occupational risk. In the absence of data demonstrating risk below
the Agency's level of concern, to be eligible for reregi strati on, labeling must be adopted that
will virtually eliminate exposure to antimycin A. Certain restrictions may be reduced or
removed upon submission of acceptable toxicity and exposure studies that demonstrate risk
would not exceed the Agency's level of concern.
a) Consuming Treated Water
Because the toxicological effects of antimycin A on humans cannot be estimated, the
Agency made the conservative assumption that exposure from consuming treated water may
pose risks of concern. To mitigate the potential risks, flowing water (including outflow from
standing water such as lakes and aquaculture ponds) from treatment areas must be
deactivated with potassium permanganate and, when drinking water intakes are present
within the treatment area, the intakes must be closed during treatment and until monitoring
samples demonstrate antimycin A levels are below the limit of detection (0.015 ppb).
Deactivation with potassium permanganate - a strong oxidizing agent that is also used to
purify drinking water - and, where required, closure of drinking water intakes within the
treatment area will ensure that antimycin A does not move beyond the intended treatment
area and inadvertently contaminate drinking water.
Page 21 of 34
-------
Upon submission of acceptable data, the registrant may request that the Agency
remove the monitoring requirement. Although not required at this time, the registrant or
other entity may choose to submit data to confirm that no exposure to antimycin A will occur
in situations where water is either treated with potassium permanganate for deactivation
purposes or is subject to an oxidative drinking water treatment regimen.
b) Consuming Treated Fish
Because the toxicological effects of antimycin A on humans cannot be estimated, the
Agency made the conservative assumption that exposure from consuming treated fish may
pose risks of concern. Humans could potentially consume treated fish from a fish
management program use (complete kill) or an aquaculture use (complete or selective kill).
Fish Management Program Use
To mitigate the potential risks from the fish management program use, consumption
of dead fish taken from treatment areas will be prohibited through posting and access area
closures. Coupled with the low likelihood that humans would scavenge for and consume
dead fish, the Agency believes posting a prohibition on consuming dead fish will preclude
human exposure to antimycin A.
Aquaculture Use
To mitigate the potential risks from the complete kill use in aquaculture, the Certified
Applicator must inform the owner/operator of the aquaculture site being treated that the
water body must not be restocked for a minimum of 7 days after treatment.
Depending on environmental conditions, the expected half-life of antimycin A ranges
from several minutes to approximately 12 hours. Based on the conservative estimate that
antimycin A will have a half-life of 12 hours, the Agency estimates that at least 99% of the
compound will have degraded after 7 days. The Agency believes a 7-day prohibition on
restocking will prevent residues in fish and, thus, preclude human exposure.
To mitigate the potential risks from the selective kill use in aquaculture, the Certified
Applicator must inform the owner/operator of the aquaculture site being treated that
surviving fish must not be harvested for food or feed for a minimum of 12 months after
treatment.
When data are not available to estimate residues of pesticides in agricultural food or
feed crops, the Agency typically requires a 12-month pre-harvest interval and classifies the
use as a non-food use. Unless adequate data are available to indicate the contrary, EPA
considers 12 months to be sufficient time to allow residues to dissipate below levels that may
pose a risk to human health.
Based on PBT Profiler modeling, antimycin A does not appear to bioconcentrate in
fish (bioconcentration factor = 3SOX). A compound is considered likely to bioconcentrate if
Page 22 of 34
-------
the bioconcentration factor (BCF) is >1000. In general, chemicals that have the potential to
bioconcentrate also have the potential to bioaccumulate. Since a BCF in fish can be readily
measured in the laboratory and bioaccumulation is much more complicated to determine, the
BCF is frequently used to predict the importance of bioaccumulation. Because of antimycin
A's relatively low BCF, the chemical is not considered likely to bioaccumulate in aquatic
food chains.
Repeat applications or long-term exposure could potentially result in increased
likelihood of bioconcentration; however, antimycin A is applied only once to catfish
fingerlings and, under static conditions, the half-life of antimycin A in water is relatively
short (tl/2 < 12 hours, pH 1 to 9). Therefore, long-term or repeat exposure to antimycin A is
not expected to occur.
Based on the chemical's low likelihood to bioconcentrate and the fact that fish would
only be exposed one time and for a short duration (<12 hours), the Agency believes the
default 12-month harvesting restriction will preclude human exposure to antimycin A in
surviving fish from a selective kill use in aquaculture. Because there is no reasonable
expectation of antimycin A residues, a tolerance is not required for antimycin A residues in
harvested fish used for food or feed.
c) Performing Recreational Activities
Because the toxicological effects of antimycin A on humans cannot be estimated, the
Agency made the conservative assumption that exposure from performing recreational
activities in treated water may pose risks of concern. To mitigate the potential risks, through
posting and access area closures, the Certified Applicator or designee under his/her direct
supervision must prohibit recreational access (e.g., wading, swimming, boating and fishing)
to the treatment area during treatment and for 7 days after treatment. Depending on
environmental conditions, the expected half-life of antimycin A ranges from several minutes
to approximately 12 hours. Based on the conservative estimate that antimycin A will have a
half-life of 12 hours, the Agency estimates that at least 99% of the compound will have
degraded after 7 days. Coupled with the relatively low exposure expected from performing
recreational activities, the Agency believes a 7-day prohibition on recreational access will
preclude human exposure to antimycin A.
d) Performing Occupational Activities
Because the toxicological effects of antimycin A on humans cannot be estimated, the
Agency made the conservative assumption that exposure from performing occupational
activities may pose risks of concern. To mitigate the potential risks, the registrant must
amend labels to specify maximum treatment concentrations of 25 ppb; require antimycin A
applications to be supervised by an on-site Certified Applicator; require all mixers/loaders
and others exposed to the concentrate through cleaning equipment to wear long-sleeved shirt
and long pants, chemical-resistant gloves, shoes plus socks, protective eyewear, a dust/mist
respirator, and a chemical-resistant apron; require all applicators and other handlers to wear
long-sleeved shirt and long pants, chemical-resistant gloves, shoes plus socks, and protective
Page 23 of 34
-------
eyewear (in addition, applicators using handheld equipment or handheld nozzles must wear a
dust/mist respirator and coveralls); and prohibit handlers from wearing contact lenses while
handling this product. The Agency believes the specification of a maximum treatment
concentration and the additional required PPE will virtually eliminate occupational human
exposure to antimycin A.
3. Ecological Risk
EPA conducted an ecological risk assessment for antimycin A to support the
reregi strati on eligibility decision and concluded that ecological risk estimates exceed OPP's
level of concern. To mitigate ecological risk, the Agency is requiring the registrant to amend
labels to prohibit antimycin A use in estuarine/marine environments; require deactivation
with potassium permanganate to ensure that antimycin A will not affect areas beyond the
treatment area; and encourage users to collect and bury dead fish. The Agency believes that
these measures will reduce the potential ecological risk posed by continued use of
antimycin A.
The mitigation measures presented in this document, in addition to the detailed
Antimycin A SOP Manual, will be incorporated in the product labeling. Certain restrictions
may be reduced or removed upon submission of acceptable toxicity and exposure studies that
demonstrate risk would not exceed the Agency's level of concern.
4. Endocrine Screening
EPA is required under the FFDCA, as amended by FQPA, to develop a screening
program to determine whether certain substances (including all pesticide active and other
ingredients) "may have an effect in humans that is similar to an effect produced by a
naturally occurring estrogen, or other such endocrine effects as the Administrator may
designate." Following the recommendations of its Endocrine Disrupter Screening and
Testing Advisory Committee (EDSTAC), EPA determined that there were scientific bases
for including, as part of the program, androgen and thyroid hormone systems, in addition to
the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the
Program include evaluations of potential effects in wildlife. When the appropriate screening
and/or testing protocols being considered under the Agency's Endocrine Disrupter Screening
Program (EDSP) have been developed and vetted, antimycin A may be subjected to
additional screening and/or testing to better characterize effects related to endocrine
disruption.
V. What Registrants Need to Do
The Agency has determined that antimycin A is eligible for reregi strati on provided
that the requirements for reregi strati on identified in this RED are implemented (see Section
IV). The registrant will also need to amend product labeling and submit an updated
confidential statement of formula for each product.
Page 24 of 34
-------
The database supporting the reregi strati on of antimycin A for piscicidal uses has been
reviewed and determined to be adequate to support a reregi strati on eligibility decision.
Additional data are not required at this time. In the future, the registrant may request that
EPA remove or reduce certain restrictions or mitigation measures upon submission of
acceptable toxicity and exposure studies that demonstrate risk exposure to antimycin A is
below OPP's level of concern and/or that no exposure to antimycin A will occur in situations
where water is either treated with potassium permanganate for deactivation purposes or is
subject to an oxidative drinking water treatment regimen.
A. Manufacturing Use Products
Currently there is no registered manufacturing use product for antimycin A. If, in the
future, manufacturing use products are registered, the registrant must include the label
requirements presented in Table 6. The Agency does not intend to issue a generic data call-
in for antimycin A at this time.
B. End-Use Products
1. Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-
specific data regarding the pesticide after a determination of eligibility has been made. The
registrant must review previous data submissions to ensure that they meet current EPA
acceptance criteria and if not, commit to conduct new studies. If a registrant believes that
previously submitted data meet current testing standards, then the study MRID numbers
should be cited according to the instructions in the Requirement Status and Registrants
Response Form provided for each product. The Agency intends to issue a separate product-
specific data call-in (PDCI) outlining specific data requirements.
Generally, registrants will have 90 days from receipt of a PDCI to complete and
submit response forms or request time extensions and/or waivers with a full written
justification. Registrants will have eight months to submit product-specific data.
2. Confidential Statement of Formula
As part of product reregistration, the registrant must submit an updated confidential
statement of formula (CSF) for each antimycin A End-Use product. Each CSF must list all
components present at a concentration of 0.1% or more by weight. These components fall
into three general categories: active ingredients, inert ingredients, and impurities. Active
ingredients are those that have some active role in controlling the pest. Inert ingredients are
intentionally added to the product to achieve effects not directly related to controlling the
pest (such as water, emulsifiers, preservatives, carriers). Impurities (also known as
contaminants) are compounds not intentionally added to the product. Impurities that do not
have toxic properties can be lumped together on the CSF as "Other ingredients" only if each
is below 0.1% by weight.
Page 25 of 34
-------
3. Labeling for End-Use Products
To be eligible for reregi strati on, labeling changes are necessary to implement
measures outlined in Section IV. Specific language to incorporate these changes is presented
in Table 7. Generally, conditions for the distribution and sale of products bearing old
labels/labeling will be established when the label changes are approved. However, specific
existing stocks time frames will be established case-by-case, depending on the number of
products involved, the number of label changes, and other factors.
Page 26 of 34
-------
Table 6. Label Changes Summary Table for Antimycin A Manufacturing-Use Products1
Description
Amended Labeling Language for Manufacturing Use Products
Placement on Label
For all Manufacturing
Use Products
"Only for formulation into a piscicide (fish kill) for the following use(s)
[MUP registrant, insert those uses that are being supported by the
RED]"
"Only for formulation into products that are classified as Restricted Use."
Directions for Use
Additional Uses
"This product may be used to formulate products for any additional
use(s) not listed on the MUP label if the formulator, user group, or
grower has complied with U.S. EPA submission requirements regarding
support of such use(s)."
Directions for Use
Environmental Hazards
Statements Required
by the RED and
Agency Label Policies
"This product is extremely toxic to fish and other aquatic organisms."
"Do not contaminate water, food, or feed by storage or disposal."
"Do not discharge effluent containing this product to sewer systems
without previously notifying the local sewage treatment plant authority."
Precautionary Statements
Currently there is no registered manufacturing use product for antimycin A.
Table 7. Label Changes Summary Table for Antimycin A End-Use Products Intended for Occupational and Residential Use
Description
Amended Labeling Language for End-Use Products
Placement on Label
RUP
"Restricted Use Pesticide"
"Due to toxicity to fish and other aquatic organisms and the need for
specialized applicator training."
"For retail sale to and use by only Certified Applicators or persons under
their direct supervision and only for those uses covered by the Certified
Applicator's certification."
This statement must appear at the very
top of the label's front panel [see 40 CFR
156.10(j)(2)(i) for more information].
No other wording or symbols may
appear above the RUP statement.
SOP Manual
"THIS PRODUCT MUST BE ACCOMPANIED BY AN EPA-
APPROVED PRODUCT LABEL AND THE EPA-APPROVED
'ANTIMYCIN A STANDARD OPERATING PROCEDURES
MANUAL.' THE ANTIMYCIN A STANDARD OPERATING
PROCEDURES (SOP) MANUAL IS LABELING. READ AND
UNDERSTAND THE ENTIRE LABELING AND SOP MANUAL
PRIOR TO USE. ALL PARTS OF THE LABELING AND SOP
MANUAL ARE EQUALLY IMPORTANT FOR SAFE AND
EFFECTIVE USE OF THIS PRODUCT."
Immediately below the RUP statement
on the label and on the cover page of the
Antimycin A SOP Manual.
Page 27 of 34
-------
Description
Amended Labeling Language for End-Use Products
Placement on Label
PPE Requirements
Established by the
RED1
for all Formulations
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are" [EUP
registrant, insert correct chemical-resistant material]. "If you want
more options, follow the instructions for category" [EUP registrant,
insert A, B, C, D, E, F, G, or H] "on an EPA chemical-resistance
category selection chart."
"All mixers/loaders and others exposed to the concentrate through
cleaning equipment or spills must wear:
* long-sleeved shirt and long pants,
* chemical-resistant gloves,
* shoes plus socks,
* protective eyewear,
* a dust/mist filtering respirator (MSHA/NIOSH approval number prefix TC-
21C), or a NIOSH approved respirator with any N, R, P, or HE filter, and
* a chemical-resistant apron."
"All applicators and other handlers must wear:
* long-sleeved shirt and long pants,
* chemical-resistant gloves,
* shoes plus socks, and
* protective eyewear."
"In addition, applicators using handheld equipment or handheld nozzles
must wear:
* a dust/mist filtering respirator (MSHA/NIOSH approval number prefix
TC-21C), or a NIOSH approved respirator with any N, R, P, or HE filter,
and
* coveralls
Exception: if the applicator is exposed to splashing water or walking in
water that is being treated, chest waders must be worn instead of
coveralls."
Precautionary Statements under the
heading "Hazards to Humans and
Domestic Animals"
Page 28 of 34
-------
Description
Amended Labeling Language for End-Use Products
Placement on Label
User Safety
Requirements
"Do not wear contact lenses while handling this product. Ocular contact
with this product can melt a contact lens onto the eye."
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no
such instructions for washables exist, use detergent and hot water. Keep
and wash PPE separately from other laundry."
"Discard clothing and other absorbent materials that have been drenched
or heavily contaminated with this product's concentrate. Do not reuse
them."
Precautionary Statements under the
heading "Hazards to Humans and
Domestic Animals" immediately
following/below the PPE requirements
User Safety
Recommendations
"User Safety Recommendations"
"Certified Applicators applying or supervising the application of this
product should attend a training program for piscicide applications."
"Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet."
"Users should remove clothing/PPE immediately if pesticide gets inside.
Then wash thoroughly and put on clean clothing."
"Users should remove PPE immediately after handling this product.
Wash the outside of gloves before removing. As soon as possible, wash
thoroughly and change into clean clothing."
Precautionary Statements under the
heading "Hazards to Humans and
Domestic Animals" immediately
following/below the Engineering
Controls.
(These statements must be placed in a
box.)
Environmental Hazards
"Environmental Hazards"
"This product is extremely toxic to fish and other aquatic organisms."
"Do not contaminate water by cleaning of equipment or disposal of
equipment wash waters."
Precautionary Statements under the
heading "Hazards to Humans and
Domestic Animals" immediately
following/below User Safety
Recommendations
Page 29 of 34
-------
Description
Amended Labeling Language for End-Use Products
Placement on Label
Personal Protective
Equipment When Re-
entering Treated Areas
"Re-entering the Treatment Area"
"For the first 7 days after treatment, handlers re-entering treated water
must wear the following PPE:
* Chest waders over long-sleeved shirt, long pants,
* chemical-resistant gloves,
* shoes plus socks, and
* protective eyewear."
Direction for Use under the heading
"Re-Entering the Treatment Area"
Complete and Selective
kills
"Complete and Selective Kills"
"This product may be used to achieve a 'complete kill' or a 'selective
kill.' Complete kills are intended to eliminate all fish in the treatment
area whereas selective kills, used only in aquaculture, are intended to
eliminate or reduce the number of only certain (more vulnerable) species.
Detailed instructions for conducting complete and selective kills are
presented in the Antimycin A SOP Manual."
Directions for Use under the heading
"Complete and Selective Kills"
Page 30 of 34
-------
Description
Amended Labeling Language for End-Use Products
Placement on Label
General Application
Restrictions for all
Formulations
"The Certified Applicator supervising the treatment must remain on-site
for the duration of the application."
"The Certified Applicator supervising the treatment must not allow
recreational access (e.g., wading, swimming, boating, fishing) within the
treatment area while antimycin A is being applied and for 7 days after
treatment. See Placarding of Treatment Areas for additional
requirements and information."
"For 'complete kill' use, do not apply this product in a way that will
result in treatment concentrations greater than 25 parts per billion. For
'selective kill' use in aquaculture, do not apply this product in a way that
will result in treatment concentrations greater than 10 parts per billion."
"Do not apply this product in a way that will contact workers or other
persons, either directly or through drift. Only protected handlers may be
in the area during application."
"Do not apply for with any application method or equipment not
specified on this label or in the SOP."
"Do not apply in a manner not specified on this label or the Antimycin A
SOP Manual."
"This product must not be applied to estuarine or marine environments."
"Where practical, users should collect and bury dead fish."
Directions for Use
Page 31 of 34
-------
Description
Amended Labeling Language for End-Use Products
Placement on Label
Additional
Requirements for Use
in Aquaculture
"Additional Requirements for Use in Aquaculture"
"When antimycin A is applied as a selective kill in aquaculture, the
Certified Applicator supervising the application must inform the
owner/operator of the aquaculture site being treated that surviving fish
must not be harvested for food or feed for a minimum of 12 months after
treatment."
"When antimycin A is applied as a complete kill in aquaculture, the
Certified Applicator supervising the application must inform the
owner/operator of the aquaculture site being treated that the water body
must not be restocked for a minimum of 7 days after treatment."
Directions for Use under the heading
"Additional Requirements for Use in
Aquaculture"
Drinking Water
Notification
Requirements
"Drinking Water Notification"
"If drinking water intakes are present within the treatment area, prior to
application, the Certified Applicator must provide notification to the
party responsible for the public water supply or to individual private
water users. Drinking water intakes within the treatment area must be
closed during treatment and until monitoring samples demonstrate that
antimycin A levels are below the limit of detection (0.015 ppb)."
"Detailed instructions for public involvement, notifications, and
monitoring are presented in the Antimycin A SOP Manual."
Directions for Use under the heading
"Drinking Water Notification"
Page 32 of 34
-------
Description
Amended Labeling Language for End-Use Products
Placement on Label
Notification
Requirements for all
applications except
aquaculture
applications
"Placarding of Treatment Areas, Except Aquaculture Applications"
"The Certified Applicator in charge of the application (or someone under
his/her supervision) must placard all access areas to the treatment area.
Detailed instructions for placarding are presented in the Antimycin A
SOP Manual. At a minimum, placards must be placed every 250 feet
(including the shoreline of the treated area and up to 250 feet of shoreline
past the application site to include immediate public access points) and
contain the following information:"
"NOTICE: AREA CLOSURE"
* Skull and crossbones symbol
* "DANGER/PELIGRO"
* "DO NOT ENTER/NO ENTRE: Pesticide Application"
* The name of the product applied
* The agency or entity performing the application
* The purpose of the application
* The start date and time of application
* The end date and time of application
* The duration of the area closure
* "Recreational access (e.g., wading, swimming, boating, fishing)
within the treatment area is prohibited while antimycin A is being
applied and for 7 days after treatment."
* "In standing water treatment areas (non-flowing water), do not
swim or wade in treated water for a minimum of 7 days after the last
application."
* "Do not consume dead fish from treated water."
* The name, address, and telephone number of the Certified
Applicator in charge of the application
"Signs must remain legible during the entire posting period and must be
removed no earlier than 7 days after treatment and no later than 14 days
after treatment."
Directions for Use under the heading
"Placarding of Treatment Areas"
Page 3 3 of 34
-------
Description
Amended Labeling Language for End-Use Products
Placement on Label
Deactivation with
Potassium
Permanganate
"Deactivation with Potassium Permanganate"
"Flowing water (including outflow from standing water) must be
deactivated with potassium permanganate to prevent exposure beyond the
defined treatment area. Detailed instructions for deactivation with
potassium permanganate are presented in the Antimycin A SOP Manual."
Directions for Use under the heading
"Deactivation with Potassium
Permanganate (KMnO4)"
1 PPE that is established on the basis of Acute Toxicity of the end-use product must be compared to the active ingredient PPE in this document. The more
protective PPE must be placed in the product labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7.
Page 34 of 34
------- |