United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-96-002
August 1996
R.E.D. FACTS
AMITROLE
Pesticide
Reregistration
Use Profile
Regulatory
History
All pesticides sold or distributed in the United States must be
registered by EPA, based on scientific studies showing that they can be
used without posing unreasonable risks to people or the environment.
Because of advances in scientific knowledge, the law requires that
pesticides which were first registered before November 1, 1984, be
reregistered to ensure that they meet today's more stringent standards.
In evaluating pesticides for reregi strati on, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency develops
any mitigation measures or regulatory controls needed to effectively reduce
each pesticide's risks. EPA then reregisters pesticides that can be used
without posing unreasonable risks to human health or the environment.
When a pesticide is eligible for reregi strati on, EPA explains the basis
for its decision in a Reregistration Eligibility Decision (RED) document.
This fact sheet summarizes the information in the RED document for
reregi strati on case 0095, Amitrole.
Amitrole is a terrestrial non-food herbicide used primarily in
industrial areas (outdoors), non-agricultural rights-of-way, fencerows,
hedgerows, non-agricultural uncultivated areas, soils, ornamental and/or
shade trees, and ornamental shrubs and vines. There are no tolerances for
any food crop or water which will be used for irritation, drinking or other
domestic purposes. Amitrole's mechanism of action inhibits carotenoid
synthesis, chlorophyll formation, and limited regrowth of buds. Amitrole
formulations include a solid/dust (technical) product, a wettable powder (in
water soluble bags), and an emulsifiable concentrate (the registrant has
requested voluntarily cancellation of this product). Amitrole is solely
applied by fixed boom sprayers attached to tractors, trucks or railway
(ground equipment).
Amitrole was first registered as a pesticide in the U.S. in 1948. The
EPA issued a Registration Standard March 30, 1984 (PB87-104766). The
Registration Standard besides requiring submission of studies informed
registrants that even though amitrole was not used on food crops and there
was no dietary exposure to the chemical the Agency had major concerns for
dermal exposure, with inhalation furnishing only a minor contribution to the
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total body burden. Human exposure, in some circumstances, occurred at
doses which resulted in antithyroid effects in laboratory animals.
Amitrole's use patterns and application techniques met the oncogenicity risk
criterion for Special Review. The Agency determined that it would not
reregister any current product and it would not register any new product
containing amitrole until all pivotal data was reviewed.
On May 15, 1984, the Agency issued a Notice of Special Review
(Position Document-1) of pesticide products containing amitrole. The
Agency's Special Review was initiated to address the use of amitrole on
non-crop sites (highway rights-of-way, primarily) and by homeowners, and
to examine the carcinogenic risk to mixers, loaders and applicators. The
data indicated that amitrole induced thyroid, pituitary and liver tumors in
laboratory animals. The registrant voluntarily acted on a number of
measures that reduced worker exposure to amitrole. Among these were the
deletion of the high exposure application methods such as knapsack
sprayers, the adoption of a "no-glug" container design for the liquid
formulation to reduce splashing while pouring, the addition of protective
clothing requirements to labels, and packaging of the wettable powder
formulation in water soluble packets. Lastly, the registrant voluntarily
canceled all homeowner products.
During the Special Review phase, two Data Call-Ins (DCIs) were
issued by the Agency. A DCI was issued on February 22, 1990 requesting
efficacy, usage and worker exposure monitoring data for both liquid and
powder formulations of amitrole. A second DCI was issued on August 16,
1991 requesting product chemistry, ecological and environmental fate
studies and toxicology studies.
Based on a risk and benefit assessment, the Agency concluded that
the benefits provided from the use of amitrole (taking into consideration the
measures previously discussed) outweigh the risks. Thus, the Agency on
October 8, 1992 issued a Notice of Final Determination (57 FR 46448) of
the Amitrole Special Review. The Agency continued to require: restricted
use (RU) classification, a cancer warning statement on the label, application
methods remain limited to boom sprayers, and protective clothing
requirements remain on the label. The Notice was published in the Federal
Register and comments were invited for 30 days. No comments were
received.
After reviewing all the submitted data and comparing other pesticidal
chemicals also classified as "restricted use," the Agency has determined that
the restricted use classification is no longer appropriate. Amitrole is
classified as a B2-probable human carcinogen. Two thirds of the Agency's
calculated cancer risk of 10"5 to mixers/loaders (assuming handlers wear
long sleeve shirts, long pants, shoes and socks) is from inhalation exposure.
The Agency believes that the likelihood of inhalation exposure is almost
non-existent since the amitrole is packaged in water soluble bags. Focusing
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only on cancer risk from dermal exposure, the estimated cancer risk
approaches 10"6. Thus, with the low dermal absorption factor (0.5%) (since
the registrant has requested voluntary cancellation of the amitrole use for
ornamental plant nurseries), continued packaging in water soluble bags,
additional protection (although minimal because of the low dermal
absorption) afforded by chemical resistant gloves and chemical resistant
apron, the Agency concluded that the Restricted Use classification could be
rescinded if the registrant agreed to the following conditions: voluntarily
cancel their liquid formulation product; retain the cancer warning label;
retain the boom sprayer as the only application mode; retain the same use
profile as a non-food use pesticide; and provide the Agency with handler
exposure studies for mixers/loaders of water soluble packages to confirm
the Agency's risk assessment and conclusions. In addition, the registrant
understands that any proposed future expansion of their market will require
that a separate risk assessment be performed for any new use/application
method. Furthermore, amitrole labels must carry a ground water advisory
and the registrant must submit additional ecological studies to complete the
Agency's risk assessment.
Human Health
Assessment
Toxicitv
In studies using laboratory animals, amitrole technical has been
shown to be in toxicity category IV and III (practically non-toxic and
slightly toxic, respectively) for acute oral and acute dermal exposure. The
requirement for an acute inhalation study was waived because a 2-year rat
inhalation study is available. Even though this study was not useful for
regulatory purposes it did show that the LC50 is probably at least greater
than 0.5 mg/1 (the highest target concentration tested). Therefore, it is
likely that the acute inhalation is at least toxicity category III. Amitrole is
also in toxicity category III for primary eye irritation and toxicity category
IV for primary dermal irrititation (both with rabbits). Amitrole is not a skin
sensitizer in guinea pigs.
NOTE: For acute oral, dietary, mammalian/avian/aquatic toxicity:
Category I = very highly or highly toxic
Category II = moderately toxic
Category III = slightly toxic
Category IV = practically non-toxic
Two human studies indicated minimal oral and dermal effects with
amitrole. A dermal absorption study with amitrole (96.4% pure) and
14-C-amitrole (4.03mCi/nmol) indicated that little or no 14-C amitrole was
absorbed over a period of up to 10 hours at dose levels up to 10.0 mg/rat.
Dietary Exposure
Amitrole is a non-food use pesticide. There are no food use patterns,
and since chronic or lifetime exposure is an unlikely scenario, an RfD is not
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required to be established nor did the Agency conduct a dietary risk
assessment.
Carcinogen classification
Amitrole has been classified as a Group B2-probable human
carcinogen by the Office of Pesticide Programs Carcinogenicity Peer
Review Committee (document dated August 30, 1991). This classification
is based on the thyroid tumors seen in the rat (both sexes, multiple strains)
and mouse (both sexes, two strains) and on liver tumors seen in the mouse
(both sexes, multiple strains) as described in studies. The Agency
calculated a Ql* of 0.68 from the thyroid tumor effects as seen in the first
long term toxicological study.
Occupational and Residential Exposure
All products containing amitrole are for occupational use only. There
are no homeowner use products containing amitrole. And although the
Agency has identified inhalation as an appropriate route of exposure on
which to conduct short term and intermediate term risk assessment, the
Agency also believes that in reality there is little likelihood of actual
inhalation exposure from mixing/loading/applying of amitrole. The
inhalation exposure estimates are very conservative because:
(1) amitrole is not volatile, (2) amitrole is only packaged in water soluble
bags (which greatly reduces the chance for incidental inhalation exposure),
(3) the inhalation exposure values presented in Table 3 reflect data from the
Agency's Pesticide Handlers Exposure Database (PHED VI. 1), which for
the water soluble packaging data set includes some instances where
detections were not found but a value of half the limit of detection was
assumed, and (4) the Agency assumed 100% adsorption of inhalation
exposure from both the oral developmental toxicity study and the
reproduction study. The assumption of half the limit of detection is a
common Agency practice in establishing exposure/residue values.
As previously discussed, the registrant voluntarily restricted the use
patterns of amitrole to reduce the exposure of amitrole to handlers. The
wettable powder and liquid concentrate formulations were voluntarily
packaged by the registrant to water soluble packets and "no-glug"
containers, respectively. The only current application method is for fixed-
boom sprayers attached to ground equipment such as tractors, trucks or
railroad wagons.
The registrant has recently requested the voluntary cancellation of the
liquid formulation (in no-glug container) and has also requested the use
deletion of the only use currently within the scope of the Worker Protection
Standard, ornamental plant nurseries.
The three exposure scenarios identified for amitrole are:
(1) Mixing/loading the liquid concentrate formulation (packaged in
no-glug containers) to support ground application. As noted
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previously, the registrant has requested voluntary cancellation
of this product. The Agency has included the mixer/loader,
exposure/risk estimates for this formulation since the voluntary
cancellation is still in process.
(2) Mixing/loading the wettable powder formulation (packaged in
water soluble bags) to support ground application, and
(3) Applying as a spray with fixed-boom ground equipment.
(Exposure data for groundboom equipment is used as a
surrogate for the fixed-boom ground equipment).
The Agency conducted an assessment of the inhalation risks
associated with amitrole following short-term and intermediate-term
exposures to occupational handlers. The Agency has determined that a risk
assessment is not required for short-term and intermediate-term dermal
exposures. Margins of exposure (MOE) for occupational inhalation
exposures were calculated for handlers using the NOELs of 4 mg/kg/day for
short-term and 0.9 mg/kg/day for intermediate-term exposure. Amitrole is
not marketed to homeowners (only application methods is fixed-boom
sprayer), therefore the sole exposure concern is for occupational handlers.
The calculations indicate that with the exception of one scenario, all of the
MOEs for short- and intermediate-term inhalation exposures at baseline
protection (i.e., no respirator) exceed 100 indicating acceptable risk. The
exception is the intermediate-term inhalation exposure of Scenario 1
(mixing/loading the liquid concentrate, which has an MOE of 82).
However, the registrant is voluntarily cancelling this formulation.
Carcinogenic Risks
The Agency conducted an assessment of the carcinogenic risks
associated with amitrole following exposures to occupational handlers
including all currently registered uses, which includes the liquid concentrate
formulation (packaged in a no-glug container) for which the registrant has
recently requested a voluntary cancellation.
The calculations indicate that the risks at baseline protection (i.e.,
long-sleeve shirt, long pants, shoes, and socks) are in the 10"5 range for
mixing/loading wettable powders (contained in water-soluble packaging)
and application using open-cab groundboom sprayers, the surrogate for
fixed-boom ground sprayers. The calculations indicate that the risks at
baseline protection are greater than 10"4 for mixing/loading liquid
formulations. These calculations do not reflect the exposure reduction
expected to be realized from the mandatory use of "no-glug" containers for
liquid formulations. The registrant has, however, recently requested
voluntary cancellation for this formulation.
The risk assessment indicates that the risks at baseline protection are
approximately 10"5 for mixing/loading the wettable powder formulation
packaged in water soluble bags. Since the risk assessment was conducted
using this assumption, the Agency is requiring that the wettable powder
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formulation continue to be marketed only in water-soluble packaging. In
addition, since the Agency has low confidence in the data used to assess
exposure to mixers and loaders using water-soluble packaging and amitrole
is a relatively potent carcinogen, additional risk reduction measures for
mixers and loaders is being required. The following risk mitigation
measures for mixers and loaders handling the wettable powder amitrole
formulations, should adequately mitigate risk to these workers:
• mandatory use of water-soluble packaging for wettable powder
amitrole formulations, and
• requiring mixers and loaders to wear a chemical-resistant apron, long-
sleeve shirt, long pants, shoes, socks and chemical-resistant gloves.
There are no amitrole-specific post-application exposure data
available. For many amitrole use scenarios, the Agency believes that the
risks from post-application exposures will not pose an unacceptable risk to
persons entering treated areas because, in general, amitrole is used in areas,
such as rights-of-way, industrial areas, permanent landscape plantings, and
other non-crop areas, where frequent or routine prolonged contact with
treated surfaces is unlikely. Therefore, the Agency has determined that
post-application exposures do not appear to pose an unreasonable risk to
persons entering treated areas, as long as entry is not permitted until sprays
have dried.
Environmental
Assessment
Environmental Fate
Acceptable and supplemental information from environmental fate
studies with respect to the persistence and mobility of amitrole under
laboratory and field conditions has been reviewed. Persistence classes
discussed in the following sections were based on the groupings (ranging
from non-persistent to persistent) published in Goring et al., (1975) and
McEwen and Stephenson (1979). The environmental fate data base for
amitrole with terrestrial non-food crop use is essentially complete.
The following information is derived from acceptable environmental
fate studies reviewed by the Agency. The studies determining laboratory
persistence (degradation and metabolism processes) indicate amitrole is
slightly to moderately persistent [aerobic soil half-life (t1/2) »22-26 days;
aerobic aquatic half-life of »57 days] with degradation primarily through
biotic processes such as microbial-mediated metabolism. Abiotic
hydrolysis is not a significant degradation process. Amitrole was reportedly
stable to photodegradation in water and was shown to photodegrade slowly
on soil with a t1/2 of >30 days. Results of the anaerobic aquatic metabolism
study demonstrate that amitrole is persistent with a t1/2 of >1 year. In an
aerobic aquatic metabolism study, amitrole was moderately persistent with
an experimentally-determined t1/2 of »57 days for a flooded sandy loam
sediment. Results of terrestrial field dissipation studies in Washington and
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Oregon show amitrole dissipating fairly rapidly under field conditions with
DT50s ranging from »17-21 days.
The mobility of amitrole was evaluated with batch equilibrium studies
and amitrole was determined to be mobile in silty clay, sandy loam, sand,
and silt soils (Kds ranged from 0.152-0.922 ml/g). The reported vapor
pressure of amitrole is 4.4 x 10"7 mm Hg (5.9 x 10"5 Pa) and the estimated
Henry's Law Constant of 1.6 x 10"15 atm-m3/mol are low; therefore,
volatilization and subsequent photodegradation in air are not considered
probable routes of dissipation.
The bioaccumulation in fish study was not submitted; however, the
high solubility (280 g/1) and low octanol/water partition coefficient
(log Kow = -0.15) indicate limited potential for bioaccumulation in fish.
Amitrole is mobile, somewhat persistent and may have the potential
to contaminate ground water. This assessment is based on the acceptable
environmental fate studies which indicate amitrole has a significant number
of characteristics in common with pesticides that are known to leach to
ground water. Amitrole is stable to hydrolysis, and aerobic soil and
anaerobic aquatic metabolism and field dissipation data indicate that it is
somewhat persistent. Amitrole is classified as mobile because the low Kd
and Koc values indicate it will not strongly adsorb to soil. Pesticides with
similar properties have been found in ground water.
Amitrole may contaminate surface water from runoff or spray drift
associated with ground spray application. Amitrole is stable to degradation
from abiotic hydrolysis and aqueous photolysis, and is slightly to
moderately persistent (aerobic soil metabolism t1/2 =22-26 days; aerobic
aquatic metabolism t1/2 »57 days) in aerobic environments. Amitrole does
not adsorb significantly to soil particles and may be transported in the
dissolved phase by runoff to surface water bodies. Amitrole's primary route
of dissipation is microbial-mediated metabolism; however, amitrole is
stable in anaerobic environments.
Ecological Effects
The acute risk to nontarget animals (birds, insects, mammals, fish and
aquatic invertebrates) is predicted to be low. Chronic risk to mammals was
identified; however, the chronic risk to other nontarget animals (birds, fish
and aquatic invertebrates) was not determined because chronic ecological
effect data were not available.
Studies indicate that amitrole is practically non-toxic to avian species
on an acute oral and subacute basis. For birds, it is important to note that
the LC50 values used to calculate the RQs were greater that the highest dose
tested (5,000 ppm). The Agency considers amitrole to represent low acute
risk to birds. At this time chronic risk to birds cannot be assessed, because
avian reproduction data are not available.
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Amitrole is practically non-toxic to small mammals on an acute oral
basis. The RQs for small herbivores and insectivores (0.13 to 0.29)
exceeded by small margins the LOCs for endangered species (0.1) and
restricted use (0.2). Amitrole however, may be hazardous to mammalian
reproduction in localized areas. Using the acceptable two-generation rat
reproduction study, the risk assessment indicates use of amitrole has the
potential for chronic risk to mammalian species and may also chronically
affect endangered mammalian species. The mammalian exposure
asssessments use residue levels which represent the maximum estimated
values, and the residues are expected to be lower on most food items.
Amitrole residues are predicted to decline by microbial-mediated
metabolism, physical removal by washoff and other dissipation pathways.
The amitrole residue levels on food items in treated areas are not known
because the treated areas are limited to nonagricultural use sites (rights-of
way, fencerows, hedgerows, etc.) and the extent of exposure may be
limited.
There is sufficient information to characterize amitrole as relatively
non-toxic to bees.
The toxicity of amitrole to most aquatic organisms tested to date
range from practically non-toxic (freshwater finfish) to moderately toxic
(marine invertebrates). Chronic risk to freshwater fish can not be assessed
because the fish life-cycle data are not available at this time.
There is sufficient information to characterize amitrole as slightly
toxic to aquatic invertebrates. However, the chronic risk to freshwater
invertebrates will be assessed once the invertebrate life cycle study is
reviewed.
The acute risk from applications of amitrole is expected to be low to
freshwater and marine/estuarine organisms. The risk quotients determined
from application rates ranging from 3.6-8.0 Ibs ai/A are less than the levels
of concern for the tested aquatic animals at all use rates, except for
marine/estuarine invertebrates. The RQ for mysid shrimp was 0.137
(8 Ibs ai/acre) which exceeded the LOCs for endangered species (0.05) and
restricted use (0.1) by a small margin. In this assessment, the screening
model GENEEC was used to model runoff from non-agricultural use sites
for amitrole. The GENEEC model was based on an agricultural use
scenario and is a conservative estimate of exposure from surface runoff
because agricultural land uses are intensive and may cover large areas.
The conclusion of low acute risk to estuarine crustaceans is based not
only on the fact that the LOCs were exceeded by a small margin, but also
because amitrole is used on non-agricultural use sites. In addition to
marginal LOG exceedances and non-agricultural uses, the amount of
amitrole applied annually in the United States is relatively small. Usage
information for amitrole in the U.S. is between 40,000 and 60,000 pounds
of the active ingredient on an annual basis. Furthermore, endangered
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Additional Data
Required
Product Labeling
Changes Required
estuarine invertebrates are not currently listed by the United States Fish
Wildlife Service (USFWS).
The available information indicates that amitrole affects the
vegetative vigor of both monocots and dicots at very low levels (<0.01 Ibs
ai/A). The risks to non-target plants from sheet and channelized runoff was
not determined with certainty because plant toxicity data were limited
(seedling emergence data are not available). Qualitatively, amitrole's broad
spectrum plant control due to its mode of action (i.e., inhibition of
carotenoid synthesis) suggests exposure of amitrole may impact non-target
plants. Based on the 3.6 to 8.0 Ibs. ai/A use rates of amitrole, risk quotients
exceed the levels of concern for terrestrial and semi-aquatic plants (1.0).
Risk quotients are based on EC25s from the dry weight parameter for wheat
(monocot) and pepper (dicot) from the vegetative vigor study. The wheat
and pepper plant EC25s were the most sensitive plants tested and the lowest
levels for the available plant toxicity data.
Because the risk assessment is incomplete for non-target terrestrial
and aquatic plants, terrestrial (seedling emergence) and aquatic plant (all
five species) testing is being required to confirm and complete the
Agency's risk assessment and conclusions.
The generic data base supporting the reregi strati on of amitrole for the
elegible uses has been reviewed and determined to be substantially
complete for all uses. Nevertheless, the following studies are required to be
conducted on the generic active ingredient: Guidelines 17-4(a) and (b),
Avian reproduction studies and, Guideline 72-4(b), Aquatic Invertebrate
Life Cycle with Daphnia Magna. Furthermore, the following confirmatory
studies are required in order to complete the Agency's risk assessment and
conclusions: Guideline 123-l(a), Terrestial Plant Testing: Seedling
Emergence only. Guideline 123-2 Aquatic Plant Testing: All five species,
and Guideline 231 and 232 Handler exposure study to provide dermal and
inhalation data on mixers and loaders during the use of water-soluble
packages.
The Agency is also requiring product-specific data including product
chemistry and acute toxicity studies, revised Confidential Statements of
Formula (CSFs), and revised labeling for reregi strati on.
All amitrole end-use products must comply with EPA's current
pesticide product labeling requirements and with the following. For a
comprehensive list of labeling requirements, please see the amitrole RED
document.
Labeling Requirements for Manufacturing-Use Products
To remain in compliance with FIFRA, manufacturing use product (MP)
labeling must be revised to comply with all current Agency (EPA)
regulations, PR Notices and applicable policies. An MP registrant may, at
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his/her discretion, add one of the following statements to an MP label under
"Directions for Use" to permit the reformulation of the product for a
specific use or all additional uses supported by a formulator or user group:
(a) "This product may be used to formulate products for specific
use(s) not listed on the MP label if the formulator, user group,
or grower has complied with U.S. EPA submission requirements
regarding support of such use(s)."
(b) "This product may be used to formulate products for any
additional use(s) not listed on the MP label if the formulator,
user group, or grower has complied with U.S. EPA submission
requirements regarding support of such use(s)."
End-Use Products
Additional 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 product specific data requirements are listed
in Appendix D, the Product Specific Data Call-In Notice.
Registrants 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 study MRID numbers should be cited according to
the instructions in the Requirement Status and Registrants Response Form
provided for each product.
Labeling Requirements for End-Use Products
Engineering Control Requirements for Pesticide Handlers
For sole-active-ingredient end-use products that contain amitrole, the
product labeling must be revised to adopt the handler personal protective
equipment/engineering control requirements set forth in this section. Any
conflicting PPE requirements on the current labeling must be removed.
For multiple-active-ingredient end-use products that contain amitrole, the
handler personal protective equipment/engineering control requirements set
forth in this section must be compared to the requirements on the current
labeling and the more protective must be retained. For guidance on which
requirements are considered more protective, see PR Notice 93-7.
Products Intended Primarily for Occupational Use
(WPS and nonWPS)
Minimum (Baseline) PPE/Engineering Control Requirements
The Agency is establishing minimum (baseline) engineering controls
for occupational uses of amitrole end-use products.
For the wettable powder packaged in water soluble packages (non
WPS), the Agency is requiring that mixers/loaders and persons cleaning
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equipment wear: long sleeve shirt and long pants, chemical resistant gloves,
chemical resistant apron, and shoes plus socks.
For the wettable powder packaged in water soluble packages (non
WPS), the Agency is requiring that applicators wear: long sleeve shirt and
long pants, and shoes plus socks.
Determining PPE Requirements for End-use Product Labels
The PPE that would be established on the basis of the acute toxicity
category of the end-use product must be compared to the active-ingredient-
based minimum (baseline) personal protective equipment specified above.
The more protective PPE must be placed on the product labeling. For
guidance on which PPE is considered more protective, see PR Notice 93-7.
Placement in Labeling
The personal protective equipment requirements must be placed on
the end-use product labeling in the location specified in PR Notice 93-7,
and the format and language of the PPE requirements must be the same as
is specified in PR Notice 93-7.
Entry Restrictions
For sole-active-ingredient end-use products that contain amitrole the
product labeling must be revised to adopt the entry restrictions set forth in
this section. Any conflicting entry restrictions on the current labeling must
be removed.
For multiple-active-ingredient end-use products that contain amitrole
the entry restrictions set forth in this section must be compared to the entry
restrictions on the current labeling and the more protective must be
retained. A specific time period in hours or days is considered more
protective than "sprays have dried" or "dusts have settled."
Products Intended Primarily for Occupational Use - WPS uses
Since the registrant's voluntary cancellation of in-scope (nursery-
stock, the only WPS use) use has been received by the Agency, an REI is
not being presented.
NonWPS use - Entry restrictions
The Agency is establishing the following entry restrictions for
nonWPS occupational uses of amitrole end-use products:
"Do not enter or allow other employees to enter the treated area until
sprays have dried."
Placement in labeling:
Place the appropriate nonWPS entry restrictions in the Directions for
Use, under the heading: "Entry Restrictions."
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Labeling Requirements
Products Intended Primarily for Occupational Use
The Agency is requiring the following labeling statements to be
located on all end-use products containing amitrole that are intended
primarily for occupational use.
Application Restrictions
"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."
User Safety Requirements
a. (Registrant: place this on the labeling if coveralls are required
for pesticide handlers on the end-use product label:}
Discard clothing or other absorbent materials that have been
drenched or heavily contaminated with this product's
concentrate. Do not reuse them.
b. (Registrant: place this on the labeling always:}
Follow manufacturer's instructions for
cleaning/maintaining PPE. If no such instructions for
washables, use detergent and hot water. Keep and wash
PPE separately from other laundry.
User Safety Recommendations
"Users should wash hands before eating, drinking, chewing
gum, using tobacco, or using the toilet."
• "Users should remove clothing 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."
Environmental Hazard Statment
The following labeling statement must be added to the
"Environmental Hazards" section on all amitrole end-use products:
Ground water label advisory
"This chemical demonstrates the properties and characteristics
associated with chemicals detected in ground water. The use of this
chemical in areas where soils are permeable, particularly where the
water table is shallow, may result in ground-water contamination."
add list of end use product labeling requirements here, summarizing every
labeling change included in chapter V. of the RED
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The use of currently registered products containing amitrole in
Conclusion accordance with approved labeling will not pose unreasonable risks or
adverse effects to humans or the environment. Therefore, all uses of these
products (not including the uses permitted with the liquid formulation in no-
glug container and the ornamental plant nursery use) are eligible for
reregi strati on.
Amitrole products will be reregistered once the required product-
specific data, revised Confidential Statements of Formula, and revised
labeling are received and accepted by EPA.
EPA is requesting public comments on the Reregi strati on Eligibility
Decision (RED) document for amitrole during a 60-day time period, as
announced in a Notice of Availability published in the Federal
Register. To obtain a copy of the RED document or to submit written
comments, please contact the Pesticide Docket, Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs (OPP), US EPA, Washington, DC 20460, telephone
703-305-5805.
Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and Reregi strati on Information System
at 703-308-7224. They also are available on the Internet on EPA's gopher
server, GOPHER.EPA.GOV, or using ftp on FTP.EPA.GOV, or using
WWW (World Wide Web) on WWW.EPA.GOV.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone
513-489-8190, fax 513-489-8695.
Following the comment period, the Amitrole RED document also will
be available from the National Technical Information Service (NTIS), 5285
Port Royal Road, Springfield, VA 22161, telephone 703-487-4650.
For more information about EPA's pesticide reregi strati on program,
the amitrole RED, or reregi strati on of individual products containing
amitrole, please contact the Special Review and Reregi strati on Division
(7508W), OPP, US EPA, Washington, DC 20460, telephone
703-308-8000.
For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN). Call toll-
free 1-800-858-7378, between 9:30 am and 7:30 pm Eastern Standard
Time, Monday through Friday.
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