GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
ARSENIC ACID
(NON-WOOD PRESERVATIVE USES)
AS THE ACTIVE INGREDIENT
CHEMICAL CODE: 006801
CASE NUMBER: GS-0389
CAS REGISTRY NUMBER: 7778-39-4
SEPTEMBER 1986
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
I. Introduction 1
II. Chemical Covered by this Standard
A. Description of Chemical
B. Use Profile
C. Regulatory History
III. Agency Assessment 6
A. Summary
B. Preliminary Risk Assessment
C. Other Science Findings
D. Tolerance Reassessment
E. Reported Pesticide Incidents
IV. Regulatory Position and Rationale 19
A. Regulatory Positions
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard 26
VI. Requirement for Submission of Generic Data 28
A. What are generic data?
B. Who must submit generic data?
C. What generic data must be submitted?
D. How to comply with DCI requirements
E. Procedures for requesting a change in protocol
F. Procedures for requesting extensions of time
G. Existing stocks provisions upon suspension or
cancellation
VII. Requirement for Submission of Product-Specific Data . .33
VIII. Requirement for Submission of Revised Labeling .... 34
IX. Instructions for Submission 35
A. Manufacturing use products (sole active)
B. Manufacturing use products (multiple active)
C. End use products
D. Intrastate products
E. Addresses
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APPENDICES
Paqe
I. DATA APPENDICES 38
Guide to Tables
Table A
Table B
II. LABELING APPENDICES 66
Summary of label requirements and table
40 CFR 162.10 Labeling Requirements
Physical/Chemical Hazards Labeling Statements
Storage Instructions
Container Disposal Instructions
III. USE INDEX APPENDIX 87
IV. BIBLIOGRAPHY APPENDICES 92
Guide to Bibliography
Bibliography
V. FORMS APPENDICES 96
EPA Form 8580-1 FIFRA §3(c)(2)(B) Summary Sheet
' EPA Form 8580-6 Certification of Attempt to Enter Into
an Agreement with Other Registrants .for
Development of Data
EPA Form 8580-4 Product Specific Data Report (End-Use
Products)
EPA Form 8580-27 Formulator's Exemption Statement
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I. INTRODUCTION
EPA has established the Registration Standards program
in order to provide an orderly mechanism by which pesticide
products containing the same active ingredient can be reviewed
and standards set for compliance with FIFRA. The standards
are applicable to reregistration and future applications for
registration of products containing the same active ingredient.
Each registrant of a product containing an active ingredient
subject to this Standard who wishes to continue to sell or
distribute that product must bring his product and labeling
into compliance with FIFRA, as instructed by this Standard.
Pesticides have been grouped into use clusters and will be
reviewed on the basis of a ranking scheme giving higher
priority to (1) pesticides in clusters used on food .and feed
crops; and T2)"pesticides produced in large volumes.
The Registration Standards program involves a thorough
review of the scientific data base 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 the pesticide; to determine the need for
additional data on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable
adverse effects" criteria of FIFRA. In its review EPA identifies:
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the
pesticide.
2. Additional studies necessary to support continued
registration. The additional studies may not have been
required when the product was initially registered or may
be needed to replace studies that are now considered
inadequate.
3. Labeling revisions needed to ensure that the product
is not misbranded and that the labeling is adequate to
protect man and the environment.
The detailed scientific review, which is not contained
in this document, but is available upon request^-, focuses on
the pesticide active ingredient. The scientific review
primarily discusses the Agency's evaluation of and conclusions
from available data in its files pertaining to the pesticide
scientific reviews may be obtained from the Information
Services Section, Program Management and Support Division,
(TS-757C), EPA, 401 M St., SW, Washington, D.C. 20460.
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active ingredient. However, during the review of these data
the Agency is also Looking for potential hazards that may be
associated with the end use products that contain the active
ingredient. The Agency will apply the provisions of this
Registration Standard to end use products if necessary to
protect man and the environment.
EPA's reassessment results in the development of a
regulatory position, contained in this Registration Standard,
on the pesticide and each of its registered uses. See Section
IV - Regulatory Position and Rationale. Based on its regulatory
position, the Agency may prescribe a variety of steps to be
taken by registrants to maintain their registrations in
compliance with FIFRA. These steps may include:
1. Submission of data in support of product registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in
the issuance of a Notice of Intent to Cancel or a Notice of
Intent to Suspend (in the case of failure to submit data).
In addition, in cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154
to examine in depth the risks and benefits of use of the
pesticide. If the Agency determines that the r-j.sVs of the
pesticide's use outweigh the benefits of use, the Agency
may propose additional regulatory actions, such as proposed
cancellation of uses of the pesticide which have been determined
to cause unreasonable adverse effects on the environment.
EPA has authority under the Data Call-in (DCI) provisions
of FIFRA sec. 3(c)(2)(B) to require that registrants submit
data to answer our questions regarding the chemical, toxico-
logical, and environmental characteristics and fate of a
pesticide. This Registration Standard lists the data EPA
believes are necessary to resolve our concerns about this
pesticide. These data are listed in Tables A, B, and C of
Appendix I. Failure to comply with the DCI requirements
enumerated in this Registration Standard may result in issuance
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by EPA of a Notice of Intent to Suspend the affected product
registrations.
FIFRA sec. 6(a)(2) requires registrants to submit factual
information concerning possible unreasonable adverse effects
of a pesticide at any time that they become aware of such
information. Registrants should notify the Agency of any
information, including interim or preliminary results of
studies, if those results suggest possible adverse effects
on man or the environment. This requirement continues as
long as the products are registered by the Agency-
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II. CHEMICAL COVERED BY THIS STANDARD
A. DESCRIPTION OF CHEMICAL
The following chemical is covered by this Registration
Standard:
Common name: Arsenic acid
Chemical name: Arsenic Acid, Orthoarsenic acid
CAS Number: 7778-39-4
OPP (Shaughnessy) Number: 006801
Empirical Formula: H3AsC>4
Trade names: Desiccant L-10®. Hi Yield® H-10, Poly
Brand Desiccant, Hi Yield® Synergized H-10®
Description of physical characteristics of chamical [Note -
Information listed refers to the pure active ingredient,
unless specified as technical grade active ingredient (TGAI)]:
Physical State — Aqueous solution (TGAI)
Color-- Pale yellow to pale green (TGAI)
Odor — None (TGAI)
Boiling Point-- Not available in Agency files.
Flash Point — Not available in Agency files.
Melting Point — Not available in Agency files.
Solubility — Highly soluble in water (TGAI)
Specific Gravity — 1.884 at 20°C (TGAI)
Stability — Reacts with bases to form salt (TGAI)
Unusual Handling Characteristics — Reacts with fabric,
galvanized metals, black iron, and certain other
metals resulting in deterioration, corrosion, or
liberation of gases (e.g., hydrogen, arsine).
B. COMPOSITION OF INORGANIC ARSENIC COMPOUNDS
Arsenic acid (H3As04) is an inorganic form of arsenic.
Arsenic exists in two oxidation or valence states, As+3
(trivalent) and As+5 (pentavalent ) . Arsenic acid is pentavalent.
Salts of arsenic may be pentavalent arsenates or trivalent
arsenites. Inorganic arsenic compounds (arsenicals) can be
transformed chemically between trivalent and pentavalent
inorganic forms depending upon environmental conditions.
Inorganic and organic forms (combined with carbon atoms) are
also interconverted in nature. In animals, similar transfor-
mations occur during metabolism in the body. Refer to
Section III.B.2. for a discussion of the metabolism of
arsenicals in animals.
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C. USE PROFILE
Type of Pesticide: Desiccant
Pests Controlled: N/A
Registered Uses: Cotton, Okra (seed production crop only)
Predominant Use: Cotton
Mode of Activity: Desiccation of foliage and stems
Formulation Types Registered: Aqueous solutions (end use only)
Method(s) of Application: Foliar spray (single application
prior to harvest)
D. REGULATORY HISTORY
The principal use of arsenic acid as a pesticide has
been as a component of wood preservative formulations.
These are not addressed in this Registration Standard, but
will be subject of a separate Registration Standard concerning
chromated arsenicals. The uses of arsenic acid subject to
this registration standard are desiccant uses on cotton and
okra seed crop.
Arsenic acid has been registered as a cotton desiccant
for over 22 years. In 1979, a non-food use on seed crop
okra was registered in the state of Arizona. Previously
registered nonwood preservative uses also included use as a
broad spectrum herbicide on Bermudagrass turf and noncrop
areas (e.g., highway and rail rights-of-way, parking lots,
drainage ditchbanks). All but the cotton and okra uses have
been voluntarily cancelled.
The Environmental Protection Agency issued a Notice of
Rebuttable Presumption Against Registration (hereafter referred
to as Special Review) for the wood preservative and non-wood
preservative uses of the inorganic arsenicals on October.18,
1978 (43 FR 48267). That notice was based on a determination
that the use of the inorganic arsenical pesticide products
met or exceeded the risk criteria for oncogenicity, mutagenicity
and teratogenicity under 40 CFR 162.11 (these risk criteria
are now found in 40 CFR 154.7).
In January 1981, the Agency issued a preliminary regulatory
determination (46 FR 13020) which proposed changes to the
terms and conditions of registration for the wood preservative
uses of the inorganic arsenicals. The non-wood preservative
products were not included in this proposed decision, but will
be the subject of a separate proposed decision in the future.
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III. AGENCY ASSESSMENT
A. SUMMARY
The Agency has reviewed all the data submitted to support
the registration of arsenic acid as well as a number of
pertinent studies in the open literature on arsenic acid and
certain other inorganic arsenicals (e.g., sodium arsenate,
sodium arsenite, arsenic trioxide, arsenic pentoxide).
Based on a review of these data, the Agency has determined
the following.(see Section B of this Part for more detailed
information):
1. Arsenic acid is acutely toxic to humans by the oral
route, as observed from its use in homicides, suicides and
poisonings. Few animal tests have been conducted for acute
toxicity, however, and data are required on formulated products
of arsenic acid.
2. Inorganic arsenic compounds (including arsenic acid)
have been classified as Group A oncogens, signifying that
there is sufficient evidence of human oncogenicity.- based on
human epidemiological studies. This conclusion is supported
by evidence of mutagenicity in numerous studies.
Excess mortality due to lung cancer was demonstrated
in several studies among smelter workers and among workers
engaged in the production of arsenical pesticides. Other
human epidemiology studies have demonstrated an association
between exposure to high levels of arsenic in drinking water
or in arsenic containing medicinal preparations and skin
cancer.
An inhalation risk assessment indicates that the risks
to mixer/loaders and applicators of arsenic acid are comparable
to those that have been tolerated for the general population
in the vicinity of smelters due to arsenic in the ambient air.
At this time the Agency is unable to estimate dermal or
dietary risks from arsenic acid pesticide uses. The EPA
Risk Assessment Forum is reevaluating the appropriate risk
model to be used for these routes of exposure to arsenic.
3. Arsenic has demonstrated a potential to cause terato-
genic or fetotoxic effects. The Agency has determined, however,
that existing animal studies on inorganic arsenicals are
inadequate for risk assessment purposes. Therefore additional
teratogenicity tests are necessary. The Agency issued a
Data Call-In (DCI) Notice on 4/7/86 requesting teratogenicity
data for inorganic arsenical wood preservatives.
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4. The use of arsenic acid as a desiccant on cotton in
Texas coastal counties may affect the Attwater's Greater
Prairie Chicken, an endangered species. The chicken feeds
in and around cotton fields from July to September and may
ingest arsenic acid-contaminated vegetation, seeds and insects.
Arsenic acid has been added to the group of pesticides used
on cotton currently being reviewed by the Office of Endangered
Species, U.S. Department of Interior. Labeling statements
will be required on an interim basis until avian acute toxicity
and avian feed residue studies are received and evaluated.
B. PRELIMINARY RISK ASSESSMENT.
There__is an extensive body of information available on
arsenic and~'i€s inorganic compounds from literature and other
sources. Therefore, although the Agency does not have specific
studies on arsenic acid per se, in many cases it is not
requiring additional data under FIFRA. This risk assessment
relies primarily on studies and documents developed for
other Agency purposes. Principal among these is a final report
of the Agency's Office of Health and Environmental Assessment
(OHEA), entitled "Health Assessment Document for Inorganic
Arsenic." This and other documents mentioned are cited in
the Bibliography (Appendix IV).
1. Acute toxicity. The acute oral toxicity of inorganic
arsenicals in humans has been well documented over centuries
of use as a poison in homicides, suicides, and from accidental
ingestion of drugs and pesticides. The pentavalent forms
are less toxic than the trivalent ones? however, the symptoms
of toxicity are the same. The reported oral toxicity of
arsenic acid in rats is 48-100 mg/kg, however, the rat is a
poor model for toxicity in man, since it binds arsenic in
the body. Man is known to be more sensitive than the rat
to arsenic poisoning on a weight basis.
Data on dermal and inhalation systemic toxicity and
skin and eye irritation potential of arsenic acid are not
available and are required to be submitted.
2. Metabolism. The in vivo metabolism of inorganic
arsenicals is well understood. The development of new analytical
techniques capable of identifying the forms of arsenic in the
body has enabled researchers to chart the biotransformations
that occur. In every mammalian system studied, inorganic
arsenicals are metabolized from the pentavalent forms (arsenic
acid, sodium arsenate) to the trivalent arsenite form. At
the same time, a methylation process results in the formation
of monomethyl and particularly dimethyl arsenic compounds.
These are subsequently excreted in the urine, usually within
several days.
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With the exception of rats, arsenic does not generally
accumulate in active tissues of the mammalian body. Retention
of arsenic in skin, hair, and nails is regarded as an excretory
mechanism. Rats, however, bind arsenic to erythrocytes,
which results in a delayed distribution to tissues and a
biological half-life of up to 90 days. For this reason,
studies using rats as the test species give atypical results.
Required testing is to be conducted with species other than
the rat to avoid anomalous findings.
3. Carcinogenicity. The Carcinogen Assessment Group
(GAG) of the Environmental Protection Agency has performed
an assessment of the weight of evidence for carcinogenicity
of inorganic arsenicals. Based on epidemiological studies
in humans and on other supportive studies and information,
the GAG coffe lorded there is sufficient evidence that inorganic
compounds of arsenic are both lung and skin carcinogens in
humans. According to the Agency's draft Guidelines for
Carcinogen Risk Assessment (January 7, 1986) inorganic arseni-
cals (including arsenic acid) have been classified in Group A
(carcinogenic to humans).
A large number of toxicological studies are available
on the oncogenicity of arsenic compounds. The most critical
and persuasive evidence linking human cancer with exposure
to inorganic arsenicals was derived from epidemiology studies.
An excess mortality due to lung cancer associated with exposure
to arsenic was demonstrated in several studies of smelter
workers and among workers engaged in the production of arsenical
pesticides. The increased mortality in these studies was
related to occupational inhalation exposure to inorganic
arsenicals.
Among the numerous available studies, the CAG based a
final risk model for occupational inhalation exposure on
three studies of copper smelter workers and on an NCI series
of statistical analyses of some of these same workers:
a. Higgins et al. (1982) conducted a followup study on
smelter workers in Anaconda, Montana, who had previously been
studied by Lee and Fraumeni in 1969. The Higgins study contains
data on 1800 men, including all of the heavy exposure workers
and 20% of the other workers from the Lee and Fraumeni study.
Cumulative exposures were estimated and information on smoking
habits was obtained for most of the cohorts. A statistically
significant increase in the number of respiratory cancers
was observed among non-smokers in the high exposure group.
This study is summarized in the OHEA report, pp. 7-104 to
7-110.
b. Lee-Feldstein (1983) surveyed 8047 smelter workers
at the same location as Higgins et al. in Anaconda, Montana.
This large study followed mortality for up to 39 years among
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workers who had been employed for at least 12 months. Workers
were categorized into heavy, medium and light exposure groups
and by length of employment. Detailed work exposure levels
and work histories were available. At all exposure levels,
there was a statistically significant number of excess respiratory
cancers. This study is summarized in the OHEA report, pp.
7-95 to 7-104.
c. Enterline and Marsh (1982) studied 2802 men who had
worked at a Tacoma, Washington, smelter for a year or more
between 1940 and 1964, with observations through 1976.
Individual exposures to airborne arsenic were estimated
using work histories and were correlated to levels of arsenic
found in urine. A statistically significant increase in
respiratory cancers was observed at the higher exposure levels
studied. This" study is summarized in the OHEA report, pp.
7-118 to 7-128.
d. Brown and Chu (1983 a, b, c) interpreted the data
of Lee-Feldstein according to a multi-stage model of carcino-
genesis, taking into account exposure rate, durations of
exposure, age at initial exposure, and time since cessation
of exposure. Brown and Chu's analysis is described in the
OHEA report, pp. 7-110 to 7-118.
The CAG used the epidemiological studies of Higgins,
Lee-Feldstein, and Enterline and Marsh and the statistical
analysis of Brown and Chu in developing its final unit risk
estimate for inhalation oncogenic risk, which is described
in the OHEA report, pp. 7-130 to 7-135.
Other human epidemiology studies have demonstrated an
association between skin cancer in non-occupational populations
and high levels of arsenic in drinking water. Persons exposed
to arsenicals in medicines have also been shown to be at
risk.
The Agency has prepared a risk model for oral exposure
to inorganic arsenicals based on an epidemiology study of
skin cancer in a section of Taiwan with high arsenic concen-
trations in well water (Tseng et al., 1968). The EPA Risk
Assessment Forum, an Agency-wide task group charged with
assessing risk issues, is-currently, reevaluating this risk
model for exposure via the oral route. Their report is
expected to be issued in late 1986 or early 1987.
In contrast to the clear association between inorganic
arsenicals and cancer in humans, arsenic carcinogenicity in
test animals has not been observed in most studies,, A few
recent reports have noted positive results. Studies in
species other than rats have generally shown negative findings.
The OHEA document (pp. 7-77 to 7-87) summarizes 32 studies
using animals, in which the majority of studies (25) were
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either negative or inconclusive. Given the extensive amount
of information on human exposures, the Agency is not requiring
additional animal studies.
4. Mutagenicity. Results from numerous mutagenic and
other genotoxic assays provide support to the carcinogenic
risk finding. The weight of evidence indicates that arsenate
and arsenite can interact with DNA in mammalian somatic and
germinal cells and therefore may have the potential to cause
heritable effects in humans.
Observed positive effects in various assays have included
chromosome-breaking effects, interference with DNA repair
mechanisms, direct toxicity to mammalian gonads, and positive
effects in ^elected microbial test systems for mutagenicity.
For example, both the pentavalent and trivalent inorganic
arsenicals have induced chromosomal aberrations in vitro in
human fibroblast cells, Syrian hamster embryo cells, and
human peripheral lymphocytes. Results for some studies are
dose-related, and arsenites are more potent than arsenates
in the induction of chromosomal aberrations in cultured
mammalian cells. In addition, among lymphocytes cultured
from exposed workers (or from patients undergoing treatment)
there is suggestive evidence of chromosomal damage by arsenic
in vivo. Furthermore, inorganic arsenic may potentiate the
effects of chromosome-damaging agents (Sram, 1976; T.-C. Lee
et al., 1986).
Evidence of the ability of inorganic arsenic to reach
the germ cells (gonads) and produce mutagenic effects in
mammals is found in the positive results in the dominant
lethal test of Sram and Bencko (1974).
There are no mutagenicity data gaps for arsenic acid.
5. Teratogenicity/Fetotoxicity- Arsenic has been
shown to cause teratogenic/fetotoxic effects when tested in
animals by routes of exposure not typical of those expected
for humans. When tested by routes by which human exposure
from pesticide use could be expected, animal studies have
been negative or inadequate to demonstrate teratogenicity/
fetotoxicity- The Agency is unable to evaluate the risks to
humans from available animal studies, and is requiring additional
teratogenicity studies.
Sodium arsenate has been shown to produce gross malfor-
mations (terata) in hamsters, rats and mice by intravenous
and intraperitoneal routes of administration. Increased
mortality, increased resorptions and decreased body weights
of fetuses have also been observed in these studies.
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By contrast, oral (gavage) studies in experimental
animals have either failed to produce gross malformations in
offspring or have produced only a slightly increased incidence
and only at dosage levels that have also caused maternal
toxicity:
a. In three mouse studies by Hood et al. using single
oral doses of 40-100 mg/kg, 60 mg/kg, and 120 mg/kg on days
7-15 of gestation, there were no teratogenic effects at lower
dosages. Slight effects were noted, but only at the 120 mg/kg
level, at which there was increased maternal toxicity as
well.
b. Kimmel and Fowler reported that administration in
the drinking water of 2.7 and 6.5 mg/kg/day of s.odium arsenate
to pregnant^rSts throughout pregnancy produced no effects.
All of the oral studies cited above were incomplete or
had deficiencies that make them unacceptable to the Agency
to fulfill teratogenicity data requirements.
Intravenous, intraperitoneal and oral studies using
sodium arsenite have yielded results almost identical to
those for sodium arsenate, but at somewhat lower dosage
levels.
Intravenous and intraperitoneal administration are not
typical of the human exposures likely from pesticide use.
Therefore, the Agency is currently unable to assess the
risks of teratogenicity/fetotoxicity likely from pesticide
use of arsenic acid. Additional studies by the oral route
are required to assess teratogenic risks.
Arsenic can cross the placental barrier in humans and
has been incriminated in neonatal deaths (Gosselin et al.,
1984). Available human studies, however, are limited to
epidemiological studies among female smelter workers in Sweden,
which showed increased spontaneous abortions and decreased
mean birthweights of offspring. These studies were designed,
however, to study exposures to a variety of diverse chemicals
in the smelter, not arsenicals alone (OHEA, 1984). Thus the
effects noted in the study cannot be attributed to arsenical
exposure per se.
6. Reproductive effects. There are insufficient data to
assess the effects of inorganic arsenicals upon reproductive
functions. In light of the Agency's concern about possible
teratogenic/fetotoxic effects of arsenicals, a reproduction
study also is required.
7. Neurotoxicity. Arsenic is known to cause neurotoxic
effects in humans, with the expression and severity of effects
dependent 'upon the route of exposure, level of arsenic, and
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duration of exposure. Acute and subchronic exposures typically
lead to peripheral neuropathy, distal muscle weakness and
loss of sensation, which may progress to paralysis and crip-
pling. Lower exposures and chronic exposures generally have
a more gradual onset of similar symptoms.
8. Other observed effects in humans. Other chronic
and subchronic effects of inorganic arsenicals that have
been observed in humans include:
—Skin toxicity, resulting in hyperpigmentation and
disorders such as eczema, redness, keratosis, loss of
nails, and swelling, which are reversible if exposure
ceases.
—ToxfBity to the blood system, resulting in blood
dyscrasias of various forms, also reversible if exposure
ceases.
—Liver and kidney toxicity, with jaundice, degeneration
of the tissues, and cirrhosis.
--Pulmonary system effects, perforation of the nasal
septum, and tracheal and bronchial effects.
9. Dietary Exposure and Risks. EPA cannot at this time
assess the oncogenic dietary risks associated with pesticide
use of arsenic acid.
Arsenic is a constituent of rock and mineral formations
in the earth's crust. Weathering of rocks and minerals and
decay of plant material appear to be major sources of naturally
occurring arsenic in soils. Additional sources of arsenic in
the environment are deposition and precipitation of airborne
particles from industrial operations.
The determination of dietary exposure resulting from
pesticide use is complicated because arsenic acid residues
cannot be chemically differentiated from background arsenic.
Further, the form and valence of arsenic is subject to change
under environmental conditions. Data identifying the species
of arsenic residues (pentavalent or trivalent) from applied
arsenic acid are not available. Determination of background
soil residue levels and identification of the form of those
residues are central to the interpretation of arsenic acid
residues in food and feed and the risks arising from them.
Residue data are required, and when submitted will be
considered in addition to the results of the oral risk model
being considered by the Risk Assessment Forum (see III.B.3).
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10. Mixer/Loader/Applicator Exposure and Risks. Mixer/
loaders of arsenic acid are estimated to have an inhalation
exposure of 0.07 mg/hr actual arsenic. This level of exposure
results in a lifetime inhalation risk of 10~4 to 10~5 to
mixer/loaders. This risk level approaches that for the
general population in areas of high exposure to ambient air
levels of arsenic, such as smelters. Inhalation exposure to
applicators is negligible.
Average dermal exposure to mixer/loaders is estimated,
base-i on surrogate data from other agricultural uses, to be
530 mg/hr. Dermal exposure to applicators is estimated to
be 24 mg/hr. These dermal exposure figures may be revised
when the results of the required dermal penetration study
and glove permeability information are submitted. Lifetime
dermal oncogerfic risk cannot be calculated at this time.
The risk model now being assessed by the Agency Risk Assess-
ment Forum will be used when completed.
11. Field worker exposure and risks. Arsenic acid is
used as a desiccant only on seed crop okra and machine harvested
cotton. After application, field workers do not enter treated
fields for 4-10 days, and then only to check the edge of the
field for readiness for harvesting. Therefore there is no
reasonable expectation of post-application exposure. The
use is for cotton, primarily in Texas/Oklahoma, and okra in
Arizona; the temperature range of 105-115*F usually necessitates
the use of enclosed harvesters and combines that are air-
filtered and air-conditioned. Thus exposure to harvester
operators is negligible.
12. Benefits. Arsenic acid is used in parts of Texas
and Oklahoma to desiccate cotton in preparation for harvesting
with a cotton stripper. This method of harvest removes a
crop (after desiccation) in one sweep--but with more leaves
and stems than a cotton picker.. Typically about one-third
of stripper acreage is chemically treated; arsenic acid
accounts for approximately 57% of such treatment.
For the stripper process to function properly, thorough
desiccation is needed to allow the cotton bolls to break
free readily from the stalk. The entire plant, not just the
leaves, must be killed to ensure that green stem trash and
newly regrown tissue will not result in excessive moisture
in the harvested cotton. Excessive moisture content will
lead to deterioration of fiber and seed quality while the
cotton is being stored in modules awaiting ginning.
In Texas and Oklahoma, much of the cotton is of a dryland
variety, with lower yields per acre than that found in the
Mississippi Delta or in irrigated areas of Arizona and Cali-
fornia. Use of arsenic acid as a desiccant also permits a
short season production system. Desiccation allows early
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harvest and destruction of crop residues before most insect
reproduction, thus diminishing the opportunity for overwintering
of boll weevils and pink bollworms. As a consequence, popu-
lations of these insects have dropped noticeably and appli-
cations of insecticides have been significantly reduced.
Although usage has varied over time, a normal year's
usage is about 5.8 million pounds active ingredient for
application on 1.3 million acres of cotton. This is about
10% of total U. S. cotton acreage, but about 25% of Texas
acreage and 12% of Oklahoma acreage. A significant portion
of the Texas acreage is in the Blacklands of the central
eastern portion of the state.
Killing frosts or paraquat may be substituted for arsenic
acid. In the Texas and Oklahoma Plains, frosts are frequently
relied on to desiccate cotton. There are disadvantages,_
however, in waiting for frosts to prepare cotton for stripping:
lint weight drops, lint color darkens, staple length diminishes,
and germination decreases. Along the Texas coast and in the
Blacklands, the lateness or infrequency of frosts prevents
reliance upon nature to desiccate cotton. Instead chemical
desiccants are used--usually arsenic acid.
The only registered alternative to arsenic acid is
paraquat. The efficacy of paraquat is affected by moisture;
if conditions are too moist, the chemical may not completely
kill the plant, thus permitting foliar regrowth between
treatment and harvest. Along the Texas coast and in the
Blacklands, paraquat is less reliable because of the generally
moist conditions of those areas. Although paraquat may
desiccate as well as arsenic acid under dry weather conditions,
it is less consistently effective than arsenic acid. Moreover,
it is generally more expensive.
C. OTHER SCIENCE ASSESSMENTS
1. Toxicity to fish and wildlife. Data are not available
to completely assess the toxicity of arsenic acid to birds; an
avian acute toxicity study is required. However, based on
avian dietary studies in mallard duck and bobwhite quail,
arsenic acid can be characterized as moderately toxic to
birds. An estimated LD-50 based on the LC-50 is 111 mg/kg
arsenic.
Arsenic acid is slightly toxic to freshwater fish, with
an LC-50 of approximately 60 ppm, and moderately toxic to
aquatic invertebrates (LC-50 of 6.5 ppm). An early life
stage study for aquatic invertebrates is required to assess
the effect of continued low-level exposure to arsenic.
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2. Endangered species. The use of arsenic acid as a
desiccant of cotton in coastal areas of Texas may pose a
hazard to the Attwater's prairie chicken, an endangered
species, in Victoria, Refugio and Fort Bend counties. The
prairie chicken uses the edges of cotton fields for feeding,
not on the cotton plants, but on field edge forbs, seeds,
grasses, and insects.
At use levels of 4.4 Ibs/A, the Agency estimates that
a bird could have an average daily intake of 73 mg/kg, well
above the endangered species trigger level of 11.1 mg/kg
(1/10 the estimated LD-50 of 111 mg/kg).
Arsenic acid is freely soluble in water, therefore
runoff from treated fields may potentially affect endangered
aquatic species. Using a 5% runoff factor, the expected
environmental concentration of arsenic acid in a one acre
pond would be 815 ppb, greater than 1/20 the LC-50 for aquatic
invertebrates. There are no endangered aquatic invertebrates
in the areas where arsenic acid is used as a desiccant;
therefore the risk is minimal.
3. Groundwater. Environmental fate data to assess the
potential of arsenic acid or its environmental degradates
to contaminate groundwater are sparse. The few data available
indicate that the desorption constant of arsenic acid is in
the range of 20-100, which suggests low leaching potential.
Elevated levels of arsenic have been reported in some ground-
waters underlying arsenic acid use areas in Texas. It is
impossible to determine whether these residues result from
pesticide use or from naturally occurring arsenic.
D. TOLERANCE REASSESSMENT
A tolerance of 4.0 ppm has been established for residues
of arsenic acid (expressed as arsenic trioxide As2C>3) in
or on cottonseed (40 CFR 180.180). No tolerances have been
established in meat, milk, fat, meat byproducts, and processed
food or feed, nor are there any Codex, Canadian, or Mexican
cotton tolerances. The use on okra seed crop has been deter-
mined to be a nonfood use.
1. Residue Data. EPA has evaluated the residue data
supporting the existing tolerance, and has determined that
the available residue data, metabolism data (both plant and
animal) and analytical methods for residue determinations
are inadequate to support the existing tolerance for arsenic
acid in cottonseed. The residue data reviewed in support
of the tolerance include the following:
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a. Analytical methodology for determining the levels of
residues of arsenic acid in plants and animals. The
analytical methods submitted were considered to be
inadequate since they are not capable of distinguishing
among the forms of arsenic in plant and animal tissues.
b. Data on the magnitude and levels of residues of arsenic
acid in cottonseed. These data were considered inadequate
because of inadequate geographical distribution of test
sites, lack of information regarding arsenic species
present, and insufficient number of tests reflecting
the 4-day preharvest interval.
2. Toxicology Data. As discussed earlier, there are
few experimental animal studies adequately characterizing
the subchrdnicf and chronic effects of arsenic acid, and the
dosage levels below which these effects are not observed (the
no observed effect level or NOEL). There is, as noted, a
substantial body of information on human long-term effects
of arsenic. Therefore, chronic feeding studies in animals
that would normally be required in support of tolerances are
not considered necessary. Reproduction and teratology studies
are required using arsenic acid or other soluble pentavalent
arsenicals, such as sodium arsenate or arsenic pentoxide.
The Agency has in the interim calculated a preliminary
acceptable daily intake (PADI) level from available data on
sodium arsenate, a pentavalent salt of arsenic acid. The
PADI is based on non-oncogenic effects observed in chronic
feeding studies. After review of the required reproduction
and teratogenicity studies, an ADI will be established using
the study which would result in the most conservative estimate.
Three chronic feeding studies for sodium arsenate are available:
a. A 2-year feeding study, on dogs (Byron et al., 1967)
using dosage levels of 5, 25, 50, and 125 ppm (expressed
as actual arsenic). Effects observed at the highest
dosage level (125 ppm) were increased mortality (1/6
dogs died), decreased body weight gain, and" mild anemia.
The NOEL for this study was 50 ppm (equivalent to 1.25
mg/kg/day actual arsenic).
b. A lifetime study in rats (Kroes et al., 1974),
using a single dosage of 416 ppm. Effects observed
were decreased body weight gain, decreased food consump-
tion, and increased erythrocyte counts in the female
rats. The NOEL, which was not determined in this study,
was therefore <416 ppm (equivalent to <20.8 mg/kg/day).
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c. A 2-year feeding study on rats (Byron et al, 1967),
using dosages of 31.25, 62.5, 125, 250 and 400 ppm.
Effects at the 400 ppm level were increased mortality,
decreased body weight gain and enlarged and/or thickened
common bile ducts in the livers of the treated animals.
The NOEL for this study was 62.5 ppm (equivalent to
3.125 mg/kg/day of sodium arsenate).
Of the studies on sodium arsenate, the dog study was selected
for the purpose of calculating the PADI because:
—The dog study provided the lowest NOEL (i.e., dogs
appear to be more sensitive than rats to sodium arsenate),
—The rat is not the test species of choice .because of
its unique ^hatacteristic of retaining arsenic in the body
rather than excreting it rapidly. The results of rat studies
are therefore atypical and inappropriate for determination of
a NOEL.
3. Provisional Acceptable Daily Intake. The tolerance
for arsenic acid is expressed as arsenic trioxide (AS2O3)
(see 40 CFR 180.180). The NOEL from the dog study must also
be expressed as AS2O3 for comparability with arsenic acid.
To convert a dosage of 1.25 mg/kg/day of arsenic (the
NOEL in the dog study) to arsenic trioxide, one must use a
conversion factor of 1.32:
1.25 mg/kg/day x 1.32 = 1.65 mg/kg/day of AS2O3.
Using the calculated NOEL of 1.65 mg/kg/day of AS203
and a safety factor of 100, the provisional ADI is
1.65 * 100 = 0.0165 mg/kg/day of AS203.
For an average 60 kg person, the Maximum Permissible
Intake or MPI is
0.0165 mg/kg/day x 60 kg = 0.99 mg/day.
The amount of arsenic (expressed as the trioxide) that
is contributed to the average diet from use of arsenic acid
on cotton (known as the Theoretical Maximal Residue Contribution
or TMRC) is 0.009 mg/day. This represents 0.9% of the amount
that is permissible for a 60 kg person.
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E. REPORTED PESTICIDE INCIDENTS
The Agency has reviewed information from its Pesticide
Incident Monitoring System (PIMS) reports from 1966-1981.
In that period of time, 28 incidents involving arsenic acid
alone were reported. Eight of these involved use of arsenic
acid as a cotton desiccant.
Of the eight incidents identified as relating to cotton
desiccant use, one involved a human fatality and two persons
hospitalized,, three involved cattle, and four involved crop
damage from spray drift.
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IV- REGULATORY POSITION AND RATIONALE
A. REGULATORY POSITIONS
1. Special Review. The Agency initiated a Special
Review for the non-wood uses of arsenic acid in 1978. The
Agency's preliminary determination is projected for issuance
in 1987. Until the conclusion of the Special Review, all
currently registered products will remain registered.
Rationale; The Agency determined in 1978 (October 18,
1978, 43 FR 48267) that the inorganic arsenicals met or
exceeded the risk criteria for Special Review on the basis of
oncogenicity, mutagenicity and teratogenicity/fetotoxocity
criteria.
2. New uses. No new uses for arsenic acid will be
approved until the conclusion of the Special Review.
Rationale; In light of the ongoing Special Review
and the concerns it raises about arsenic acid, EPA believes
it prudent not to expand the uses or increase potential
exposure to arsenic acid.
3. Restricted Use; Arsenic acid products will be
restricted to use by certified applicators.
Rationale; The Agency has determined that arsenic
acid products exceed the criteria for Restricted Use classi-
fication stated in 40 CFR 162.ll(c)(2)(ii). First, arsenic
acid is highly toxic to humans by the oral route, thus meeting
the criterion for restriction on an acute toxicity basis
(§ 162.11(c)(2)(ii)(A)). Second, arsenic has been categorized
as a Class A oncogen, thus meeting the criterion for restriction
on a chronic toxicity basis (§ 162.11(c)(2)(ii)(B)).
EPA believes that, to minimize the risks to mixer/loaders
and applicators, use should be limited to persons who have
been trained in proper use procedures and exposure reduction
measures.
4. Groundwater Concerns; The Agency will not place any
restrictions on use of arsenic acid products at this time
based upon potential groundwater contamination.
Rationale: Available data indicate that arsenic acid
residues have a low leaching potential. Although arsenic
has been detected in groundwater, the available data do not
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permit EPA to determine whether the source of the residues
was pesticide use, naturally occurring arsenic in the soil,
or arsenic deposited on the soil from non-pesticidal sources.
A decision on regulatory action will be deferred until the
results of the soil column leaching study and supplemental
leaching data specified in Table A are submitted.
5. Reentry Requirements; The Agency will not impose any
reentry requirements for the currently registered uses of
arsenic acid [i.e., cotton and okra (seed crop)].
Rationale; After spray residues of arsenic acid
have dried on the fields, they are not generally dislodgeable.
Moreover, workers do not enter the treated fields for 4-10
days, and only to inspect the fields just prior to the projected
harvest date €o insure that the crop is sufficiently desiccated
for harvest. These workers would only be inspecting a limited
portion of treated fields near the end of the established
preharvest intervals (i.e., 4 and 10 days after treatment
for cotton and okra, respectively). Therefore EPA has determined
that reentry intervals are not needed.
6. Protective Clothing Requirements; The Agency will
require that protective clothing be worn by mixer/loaders
and applicators. Product labels will be required to specify
that mixer/loaders wear chemical resistant protective suits,
gloves and boots and eye protection. Applicators will be
required to wear a protective suit. The Agency will also
require that a special study on glove permeability be conducted.
Rationale; Arsenic acid end use products are toxic
and oncogenic. Protective clothing is necessary to minimize
exposure during mixing, loading and application in order to
protect against acute toxicity as well as potential oncogenic
risk. Eye protection is required for mixer/loaders because
the product is an acid. The glove permeability study will
permit the Agency to evaluate dermal exposure and risks with
protective clothing.
7. Endangered Species Concerns; The Agency will require
ail end-use products intended for use as a cotton desiccant
to contain endangered species labeling to protect the Attwater's
Greater Prairie Chicken in Texas. labeling statements will
require users to obtain and review a bulletin on use in
areas where the Attwater's Greater Prairie Chicken is found,
and, in those areas, not to use arsenic acid. The Agency
has included arsenic acid in its cluster of cotton pesticides.
The addition of arsenic acid is currently being reviewed by
the Office of Endangered Species (OES), U.S. Department of
the Interior (USDI). To further evaluate the hazard to
birds, including endangered species, the Agency is requiring
an avian acute toxicity study and a residue monitoring field
study on avian food items associated with cotton fields.
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Rationale; The referral to the OES, USDI, and the
labeling statements are based upon calculations comparing
the expected environmental concentration of arsenic acid
with estimated avian toxicity levels. The Agency derived an
estimated avian LD5Q from the avian dietary LC5Q study.
From the use rate of arsenic acid on cotton, EPA. calculated
the environmental concentration level on various bird feed
items around cotton fields. The calculated expected environ-
mental concentration exceeds 1/10 the estimated avian LD-50,
and thus arsenic acid exceeds the criterion for referral to
OES, USDI for an endangered species opinion.
The Agency is requiring actual residue monitoring of
avian feed items and an avian LD-50 study to verify its
theoretical calculations. In the interim, endangered species
labeling wiTl be used to protect endangered bird species
likely to be found in treated areas.
8. Tolerance Reassessment; The Agency will reassess
the adequacy of the existing tolerance after required metabolism
data and residue data have been submitted. Current grazing/feeding
restrictions will remain in effect. The Agency has required
residue metabolism studies on cottonseed, ruminants, and
poultry, crop residue field trial data on cotton, and processed
food/feed data for cottonseed in the Data Call-in (DCI)
issued on February 10, 1986.
Rationale? There are insufficient data to determine
whether a change in the present tolerance for cottonseed is
needed. Available residue data have been determined to be
inadequate and additional toxicology data are required.
9. Rotational Crop Label Restrictions; The Agency
is not at this time requiring rotational crop restrictions.
If required data demonstrate that followup crops take up
arsenic residues from soil, rotational crop restrictions or
tolerances in those crops may be necessary.
Rationale; The Agency lacks data at the present time
to determine whether planting food or feed crops-in arsenic
acid treated soils would result in illegal residues in these
crops. Several factors lead the Agency to believe that
rotational crop restrictions are not necessary to prevent
illegal residues: (1) Arsenic is bound to soil, thereby
limiting its bioavariability in following crops, such that
uptake is not expected? and (2) If there were uptake of arsenic
in rotational crops, phytotoxicity would occur at very low
levels, limiting the potential residues in the plant.
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11. Continuation of Registration: While data gaps are
being filled, currently registered end-use products (EPs)
containing arsenic acid as the sole active ingredient may be
sold, distributed, and used, subject to the terms and conditions
specified in this Standard. Registrants must provide or
agree to develop additional data, as specified in the Data
Appendices, in order to maintain existing registrations.
Rationale; Under FIFRA, the Agency does not normally
cancel or withhold registration simply because data are
missing or are inadequate (see FIFRA sec. 3(c)(2)(B) and
3(c)(7), unless available data indicate that use of the
product is likely to cause unreasonable adverse effects on
the environment.
Issuance of this Standard provides a mechanism for
identifying data needs. After receipt and review of the
data, the Agency will determine if additional regulatory
changes are necessary.
B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard,
products must contain arsenic acid as the sole active ingredient,
bear required labeling, and conform to the product composition,
acute toxicity limits, and use pattern requirements listed
in this section.
C. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
To be registered or reregistered under this Standard,
manufacturing-use products (MPs) must contain arsenic acid
as the sole active ingredient. Each MP formulation proposed
for registration must be fully described with an appropriate
certification of limits, stating maximum and minimum amounts
of the active ingredient and inert ingredients which are
present in products, as well as impurities found at greater
than 0.1%.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade
and manufacturing-use products containing arsenic acid provided
that the product labeling bears appropriate precautionary state-
ments for the acute toxicity category in which each product is
placed.
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3. Use Patterns
To be registered under this Standard, manufacturing-use
products may be labeled for formulation into end-use products
only for the commodities listed below. The Use Index lists
all registered uses, as well as approved maximum application
rates and frequencies.
-Terrestrial, non-domestic, food use on:
Cotton
-Terrestrial, non-domestic, nonfood use on:
Okra (seed crop only)
D. REQUIRED LABELING
All arsenic acid products (manufacturing and end use)
must bear appropriate labeling as specified in 40 CFR 162.10.
Appendix II contains information on label requirements.
No pesticide product containing arsenic acid may be
released for shipment by the registrant after September 30,
1987, unless the product bears an amended label which
complies with the requirements of this Standard.
No pesticide product containing arsenic acid may be
distributed, sold, offered for sale, held for sale, shipped,
delivered for shipment, or received and (having so received)
delivered or offered to be delivered by any person after
September 30, 1988, unless the product bears an amended
label which complies with the requirements of this Standard.
The following information must appear on the labeling:
1. Ingredients Statement
The ingredient statement for all products must
list the active ingredient as "Arsenic acid" and must
contain a substatement which indicates the percentage
of "Total Arsenic (water soluble), expressed as metallic"
2. Use Pattern Statements
All manufacturing-use products must state that they
are intended for formulation into end-use products for
acceptable use patterns. Labeling must specify sites,
which are listed in Use Patterns, Section C.3. However,
no use may be included on the label where the registrant
fails to agree to comply with the data requirements in
TABLE A for that use pattern.
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3. Precautionary Statements for all products .
When mixing/loading or otherwise handling the concen-
trate wear midforearm to elbow length chemical resistant
gloves, chemical resistant shoes or boots, goggles or
face shield, and a protective suit which has long sleeves
and long pants. The protective suit must be worn over
normal work clothes.
4. Precautionary Statements for Manufacturing-Use Products
N/A (none registered for non-wood preservative uses)
5. Precautionary Statements for End-Use Products
ATI end use products must bear the following statements:
a. RESTRICTED USE PESTICIDE
DUE TO ACUTE TOXICITY AND
ONCOGENICITY
For retail sale to and use only by certified applicators
or persons under their direct supervision, and only
for those uses covered by the certified applicator's
certification.
[The restricted use statement must appear at the top
of the front panel of the label.]
b. When applying the diluted spray solution wear a
protective suit which has long sleeves and long
pants, chemical resistant gloves, and chemical
resistant shoes or boots. The protective suit
must be worn over normal work clothes.
c. When applying the dilute spray from an enclosed
aircraft cockpit or enclosed tractor cab wear an
uncontaminated long sleeve shirt and long pants.
Any article of clothing worn while applying the
product must be cleaned before reusing." Launder
workclothes separate from household articles.
Clothing which has been drenched or heavily contam-
inated should be disposed of in accordance with
state or local regulations.
d. This pesticide is toxic to wildlife. Do not
apply directly to water or wetlands (swamps, bogs,
marshes and potholes). Do not contaminate water by
cleaning of equipment or disposal of wastes.
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e. Cotton desiccant use only: "The use of any
pesticide in a manner that may kill or otherwise
harm an endangered or threatened species or adversely
modify their habitat is a violation of federal
laws. The use of this product is controlled to
prevent death or harm to endangered or threatened
species that occur in the following counties or
elsewhere in their range.
Before using this pesticide in the following counties,
you must obtain the Cropland Endangered Species Bulletin
(EPA/ES-CROP). The use of this pesticide is prohibited
in these counties unless specified otherwise in the
Bulletin. The EPA Bulletin is available from
either your County Agricultural Extension Agent,
tTfe Endangered Species Specialist in your State
Wildlife Agency Headquarters or the appropriate
Regional Office of the U.S. Environmental Protection
Agency (EPA). This Bulletin must be reviewed prior
to pesticide use and and retained.
Texas Counties Endangered Species
Fort Bend, Refugio, Attwater's Greater
Victoria Prairie Chicken
f. Do not graze or use treated plants or gin trash
for food or forage.
g. (Product name) is injurious to all plant foliage.
h. Pesticide wastes are acutely hazardous. Improper
disposal of excess pesticide, spray mixture or rinsate
is a violation of Federal law. If these wastes cannot
be disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control
Agency or the Hazardous Waste representative at the
nearest EPA Regional office for guidance.
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
Identified In Section II.A. are subject to certain requirements
for data submission or changes in composition, labeling or
packaging of the product. The applicable requirements depend
on whether the product is a manufacturing or end use product
and whether the pesticide is the sole active ingredient or
one of multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as
the sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and B2
3. The labeling requirements specified for manufacturing
use products in Section IV.
*». Administrative requirements (application forms, Confiden-
tial Statement of Formula, data compensation provisions)
associated with rereglstration.
2 Data requirements are listed in the three Tables in
Appendix I of this Registration Standard. The Guide to
Tables in that Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to all
products containing the pesticide subject to this Registra-
tion Standard. Table B lists product-specific data applicable
to manufacturing use products. The data in Tables A and B
need not be submitted by a producer who is eligible for the
formulator's exemption for that active ingredient.
Table C lists product-specific data applicable to end use
products. The Agency has decided that, in most cases, it
will not require the submission of product-specific data for
end use products at this time. Therefore most Registration
Standards do not contain a Table C.
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B. Manufacturing use products containing this pesticide
as one of multiple active ingredients are subject to:
The data requirements listed in Table A.
C. End use products containing this pesticide as the
sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to the
end use product.
2. If eligible for the formulator's exemption3, the
data requirements listed in Table C.
srz- _^_
3. If not eligible for the formulator's exemption, the
data requirements listed in Table A and the data require--
ments listed in Table C.
4. The labeling requirements specified for end use
products in Section IV.
D. End use products containing this pesticide as one of
multiple active ingredients are subject to:
a. If not eligible for the formulator's exemption,
the date requirements listed in Tables A and C.
b. If eligible for the formulator's exemption, the
data requirements listed in Table C.
3 If you purchase from another producer and use as the
source of your active ingredient only EPA-registered products,
you are eligible for the formulator's exemption for generic
data concerning that active ingredient (Table A) and product-
specific data for the registered manufacturing use product
you purchase (Table B).
Two circumstances nullify this exemption:
1) If you change sources of active Ingredient to an
unregistered product, formulate your own active ingredient,
or acquire your active ingredient from a firm with ownership
in common with yours, you individually lose the exemption
and become subject to the data requirements in Table A.
2) If no producer subject to the generic data requirements
in Table A agrees to submit the required data, all end use
producers lose the exemption, and become subject to those
data requirements.
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VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice
issued under the authority of PIPRA sec. 3(c)(2)(B). It
refers to the data listed in Table A, which are required to
be submitted by registrants to maintain in effect the regis-
tration of products containing this active ingredient. **
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other Ingredients.
(unless the product bears labeling that would make the data -
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often required
for ecological effects studies and applies to all products
having that formulation type. These are classed as generic
data, and are contained in Table A.
B. Who must submit generic, data?
All current registrants are responsible for submitting
generic data in response to a data request under PIPRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (PIPRA sec. 3(c)(2)(D) and § 152.85) to submit
generic data in response to a DCI notice if the registrant
who supplies the active Ingredient in his product is complying
with the data request.
If you are not now eligible for a formulator's exemption,
you may qualify for one if you change your source of supply
to a registered source that does not share ownership in
common with your firm. If you choose to change sources of
supply, the Confidential Statement of Formula must identify
.the new source(s) and you must submit a Formulator's Exemption
Statement form.
If you apply for a new registration for products containing
this active ingredient after the Issuance of this Registration
Standard, you will be required to submit or cite generic
data relevant to the uses of your product if, at the time
** Registrations granted after Issuance of this Standard
will be conditioned upon submission or citation of the data
listed in this Registration Standard.
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the application is submitted, the data have been submitted
to the Agency by current registrants. If the required data
have not yet been submitted, any new registration will be
conditioned upon the new registrant's submission or citation
of the required data not later than the date upon which
current registrants of similar products are required to provide
such data. See PIFRA sec. 3(c)(7)(A). If you thereafter fail
to comply with the condition of that registration to provide
data, the registration may be cancelled (PIPRA sec. 6(e)).
C. Wnat generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed
to evaluate ^current uses of all products containing this
active Ingredient, the uses for which such data are required,
and the dates by which the data must be submitted to the
Agency.
D. How to comply with PCI requirements.
Within 90 days of your receipt of this Registration
Standard, you must submit to EPA a completed copy of the form
entitled "PIPRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1, enclosed) for each of your products. On that form
you must state which of the following six methods you will
use to comply with the DCI requirements:
1. You will submit the data yourself.
2. You have entered Into an agreement with one or more
registrants to Jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
submit the data on which you will rely. You must also provide
EPA with documentary evidence that an agreement has been
formed which allows you to rely upon the data to be submitted.
Such evidence may be: (1) your letter offering to join in
an.agreement and the other registrant's acceptance of your
offer, (2) a written statement by the parties that an agreement
exists, or (3) a written statement by the person who will be
submitting the data that you may rely upon Its submission.
The Agency will also require adequate assurance that the
person whom you state will provide the data Is taking appropriate
steps to secure It. The agreement to produce the data need
not specify all of the terms of the final arrangement between
the parties or a mechanism to resolve the terms.
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3. You have attempted to enter Into an agreement to
Jointly develop data, but no other registrant has accepted
your offer. You request that EPA not suspend your registration
for non-compliance with the PCI. EPA has determined that,
as a general policy, it will not suspend the registration of
a product when the registrant has in good faith sought and-
continues to seek to enter into a data development/cost
sharing program, but the other registrants developing the
data have refused to accept its offer. [If your offer is
accepted, you may qualify for Option 2 above by entering
into an agreement to supply the data.]
In order to qualify for this method, you must:
1. File^ith EPA a completed "Certification of - Attempt _
to Enter into an Agreement with other Registrants for Develop-
ment of Data" (EPA Form 8580-6, enclosed).
2. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must,
at a minimum, contain the following language or its equivalent:
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(B) in the [name of active ingredient] Registration
Standard upon terms to be agreed or failing agreement
to be bound by binding arbitration as provided by FIFRA
section 3(c)(2)(B)(iii).
The remainder of your offer may not in any way attempt to
limit this commitment. If the other registrant to whom your
offer is made does not accept your offer, and if the other
registrant informs us on a DCI Summary Sheet that he will
develop and submit the data required under the DCI, then you
may qualify for this option. In order for you to avoid
suspension under this method, you may not later withdraw or
limit your offer to share in the burden of developing the
data. In addition, the other registrant must fulfill its
commitment to develop and submit the data.
4. You request a waiver of the data requirement. If
you believe that a data requirement does not (or should not)
apply to your product or its uses, you must provide EPA with
a statement of the reasons why you believe this is so. Your
statement must address the specific composition or use factors
that lead you to believe that a requirement does not apply.
Since the Agency has carefully considered the composition and
uses of pesticide products in determining that a data require-
ment applies, EPA does not anticipate that many waivers will
be granted. A request for waiver does not extend the time-
frames for developing required data, and if your waiver
request is denied, your registration may be suspended if you
fail to submit the data.
30
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5. You request that EPA amend your registration by deleting
the uses for which the data are needed. You are not required
to submit data for uses which are no longer on your label.
6. You request voluntary cancellation of the registration
of your product(s) for which the data are needed.
E. Procedures for requesting a change in testing protocol.
If you will generate the required data and plan to use
test procedures which deviate from (or are not specified in)
either EPA's Pesticide Assessment Guidelines or the Reports
of Expert Groups to the Chemicals Group, Organization for
Economic Cooperation and Development (OECD) Chemicals Testing
Programme, you must submit for EPA approval the protocols
you propose to use.
You should submit your protocols before beginning testing
and await EPA approval, because the Agency will not ordinarily
accept as sufficient studies using unapproved protocols.
A request for protocol approval will not extend the timefrarae
for submission of the data, nor will extensions generally be
given to conduct studies due to submittal of inappropriate
protocols.
P. Procedures for requesting extensions of time.
If you think that you will need more time to generate
the data than is allowed by EPA's schedule, you may submit a
request for an extension of time. Any request for a time
extension which is made as an initial response to a section
3(c)(2)(B) request notice must be submitted in writing to
the Product Manager listed at the end of this section and
must be made before the deadline for response. Once dates
have been committed to and EPA has accepted these commitments,
any subsequent requests for a time extension must be submitted
in writing to the Office of Compliance Monitoring.
EPA will view failure to request an extension before
the response deadline as a waiver of any future claim that
there was insufficient time to submit the data. While EPA
considers your request, you must strive to meet the deadline
for submitting the data.
The extension request should state the reasons why you
believe that an extension is necessary and the steps you
have taken to meet the testing deadline. Time extensions
normally will not be granted due to problems with laboratory
capacity or adequacy of funding, since the Agency believes
that with proper planning these can be overcome. Time extensions
may be considered when Joint data development is planned,
31
-------
or when the Agency must approve a new or modified protocol
before the study can be begun.
A request for an extension does not extend the tlraeframe
for submission of the data. If EPA denies your request for
a time extension and you do not submit the data as requested,
EPA may begin proceedings to suspend the registrations of
your products.
G. Existing stocks provision upon suspension or cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under
FIFRA sec. 3*4cJ(2)(B), an existing stocks provision Is not
consistent with the Act. Accordingly, the Agency does not
anticipate granting permission to sell or distribute existing .
stocks of suspended product except in rare circumstances.
If you believe that your product will be suspended or cancelled
and that an existing stocks provision should be granted, you
have the burden of clearly demonstrating to EPA that granting
such permission would be consistent with the Act. The following
information must be included in any request for an existing
stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of
existing stocks and your estimate of the time required
for their sale or distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of PIPRA.
32
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VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing
using a specific formulated product, and, unlike generic
data, generally support only the registration of that product.
All such data must be submitted by the dates specified in
this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data
are listed in Table C. As noted earlier, the Agency has
decided that it will not routinely require product-specific
data for enchase products at this time. Therefore, Table C -
may not be contained in this Registration Standard; if there
is no Table C, you are not required to submit the data at
this time.
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section IV.D, E, P, and G. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options IV.D.I. (submit data)
or IV.D.6.(cancellation of registration).
Failure to comply with the product-specific data require-
ments for your products will result in suspension of the
product's registration.
33
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VIII. REQUIREMENT FOR SUBMISSION OF REVISED LABELING
PIPRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the Agency's assessment of the data supporting the product
and its uses. General labeling requirements are set out in
40 CPR 162.10 (see Appendix II - LABELING and SUMMARY). In
addition, labeling requirements specific to products containing
this pesticide are specified in Section IV.D of this Registra-
tion Standard. Applications submitted in response to this
notice must include draft labeling for Agency review.
If you fail to submit revised labeling as required,
which complies with 40 CPR 162.10 and the specific Instructions
in Section IVvD., EPA may seek to cancel or suspend the
registration of your product under PIPRA sec. 6.
34
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IX. INSTRUCTIONS FOR SUBMISSION
A. Manufacturing Use Products (MUPs) containing Arsenic
acid as sole active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division
for each product subject to this Registration Standard:
a. The "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA
Form 8580-1), with appropriate attachments.5
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form
if applicable.
d. Evidence of compliance with data compensation
requirements of PIFRA sec. 3(c)(l)(D). Refer to 40 CFR
152.80-152.99-
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Application for Pesticide Registration (EPA
Form 8570-1).
b. Two copies of any required product-specific data
(See Table B).
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
Labeling should be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for
storage in 8-1/2 x 11 files. The draft label must indicate
the intended colors of the final label, clear indication
of the front panel of the label, and the intended type
sizes of the text.
d. Product Specific Data Report (EPA Form 8580-4).
5 If on the Summary Sheet, you commit to develop the data,
present arguments that a data requirement is not applicable
or should be waived, or submit protocols or modified protocols
for Agency review, you must submit a copy of the Summary
Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data
generated in response to this notice. This submission is in
addition to responding to the Product Manager, and should be
submitted to the Office of Compliance Monitoring at the
address given at the end of this section. (Actual studies
are not to be submitted to the Office of Compliance Monitoring.)
35
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3. Within the times set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
B. Manufacturing Use Products containing Arsenic Acid
in combination with other active ingredients.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. PIPRA sec. 3(c)(2)(B) Summary Sheet, with appropriate
attachments5 (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
c. Formulator's Exemption Statement (EPA Form ),
if applicable.
2. Within the time frames set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
C. End Use Products containing Arsenic Acid as the sole
active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA Section 3(c)(2)(B) Summary Sheet, with
appropriate attachments? (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form ),
if applicable.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Two copies of any product-specific data, if required
by Table C.
b. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
36
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c. Three copies of draft labeling, Including the container
label and any associated supplemental labeling. Labeling should
be either typewritten text on 8-1/2 x 11 inch paper or a mockup
of the labeling suitable for storage in 8-1/2 x 11 files. The
draft labeling must indicate the intended colors of the final
label, clear indication of the front panel of the label, and
the intended type sizes of the text. End use product labeling
must comply specifically with the instructions in Section IV
(Regulatory Position and Rationale).
D. Intrastate Products containing Arsenic Acid either as
the sole active ingredient or in combination with other
active ingredients.
These products are being called in for full Federal regis-
tration. Producers of these products are being sent a letter
instructing them how to submit an application for registration.
E. Addresses
The required information must be submitted to the following
address:
Richard P. Mountfort PM-23
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
The address for submissions to the Office of Compliance
Monitoring is:
Laboratory Data Integrity Program
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460.
37
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I. DATA APPENDICES
38
-------
TGUIDE-1
GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements
for the pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
Table C contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CPR Part 158.
The reference numbers accompanying each test refer to the
test protocols set out in the Pesticide Assessment Guidelines,
which are available from the National Technical Information
Service, 5285 Port Royal Road, Springfield, VA 22161.
2. Test Substance (Column 2). This column lists the composition
of the test substance required to be used for the test, as
follows :
TGAI = Technical grade of the active Ingredient
PAI = Pure active ingredient
PAIRA = Pure active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product
EP = End use product
CHOICE = Choice of several test substances on a
case-by-case basis
Any other test substances, such as metabolites, jfill be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3).- This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 CPR Part 158. The following
letter designations are used for the given use patterns:
A = Terrestrial, food
B = Terrestrial, non-food
C = Aquatic, food
D = Aquatic, non-food
E = Greenhouse, food
P = Greenhouse, non-food
G = Forestry
f= Domestic outdoor
= Indoor
39
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TGUIDE-2
Any other designations will be defined in a footnote to the table.
A. Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that completely satisfy
"this data requirement. These data may be cited by
other registrants in accordance with data compensation
requirements of Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such data
do not fully satisfy the data requirement. In some cases,
the Agency may possess data on one of two required species,
or may possess data on one test substance but not all.
The term may also indicate that the data available to
EPA are incomplete. In this case, when the data are
clarified, or additional details of the testing submitted
by the original data submitter, the data may be determined
to be acceptable. If this is the case, a footnote to
the table will say so.
NO - EPA either possesses no data which are sufficient
to fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional infor-
mation.
5. Bibliographic citation (Column 5). If the Agency has
acceptable data in its files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no
MRID number has been assigned. Refer to the Bibliography
Appendices for a complete citation of the study.
6. Must additional data be submitted? (Column 6). This
column Indicates whether the data must be submitted to the
Agency. If column 3 indicates that the Agency already has
data, this column will usually Indicate NO. If column 3
indicates that-the -Agency has only partial data or no data,
this column will usually indicate YES. In some -cases, even
though the Agency does not have the data, EPA will not require
its submission because of the unique characteristics of the
chemical; because data on another chemical can be used to
fulfill the data requirement; or because the data requirement
has been waived or reserved. Any such situation will be
explained in a footnote to the table.
7. Time frame for submission (Column 7). If column 5 requires
that data be submitted, this column indicates when the data
are to be submitted, based on the issuance date of the Regis-
tration Standard. The timeframes are those established either
as a result of a previous Data Call-in letter, or standardized
timeframes established by PR Notice 85-5 (August 22, 1985).
8. Footnotes (at the end of each table). Self-explanatory.
40
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GENERIC DATA REQUIREMENTS FOR ARSENIC ACID
Data Requirement Test Use Does EPA Bibliographic
Substance Patterns Have Data?!/ Citation!/
§158.120 Product Chemistry
Product Identity
61-2 - Description of Beginning TGAI All No N/A
Materials and Manufacturing
Process
61-3 - Discussion of Formation of TGAI All No N/A
Impurities
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis TGAI All No N/A
Physical and Chemical
Characteristics
Must Additional Time Frame
Data be for
Submitted? Submission
i/
Yes 6 Months
2/
Yes 6 Months
Yes 12 Months
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
63-7 - Density, Bulk Density, or
Specific Gravity
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
All
All
All
All
All
All
No
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
N/A
Yes
Yes
Yes
Yes
Yes
Yes
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
-------
TABIE A
GENERIC DATA REQUIREMENTS FOR ARSENIC ACID
Data Requirenient
Test Use
Substance Patterns
Does EPA Bibliographic Must Additional Time Frame
Have Data?I/Citationl/ Data be for
Submitted? Submission
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-8 - Solubility
63-9 - Vapor Pressure
63-10 - Dissociation constant
63-11 - Octanol/water partition
coefficient
63-12 - pH
63-13 - Storage Stability
Other Requirements:
64- 1 - Submittal of samples
TGAI or PAI All
TGAI or PAI All
TGAI or PAI All
PAI All
TGAI All
TGAI All
TGAI, PAI All
No
No
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Yes
Yes
Yes
Yes
Yes
Yes
Yes
6 Months
6 Months
6 Months
6 Months
6 Months
15 Months
6 Months
I/ Not applicable. Although product chemistry data may have been submitted in the past, the Agency has determined that
these data must be resubmitted for each pesticide. New requirements have been introduced and previously submitted
data must be updated. Therefore bibliographic citations for the old data are not applicable.
2/ From the date of receipt of the "Da'ta Call-in Notice" for arsenic acid issued 2/10/86.
-------
TABIE A
GENERIC DATA REQUIREMENTS FOR ARSENIC ACID
Data Requirement Test Substance
§158.125
171-2 -
171-4 -
—
—
171-4 -
—
-
171-4 -
Residue Chemistry
Chemical Identity TGAI
Nature of Residue
(Metabolism)
Plants PAIRA
Livestock PAIRA
Residue Analytical Method
Plant residues TGAI
Animal residues TGAI
Magnitude of the Residue-
Residue Studies for Each
Pood Use
o Cotton
i
— Crop field trials TEP
— Processed Pood/Peed EP
— Meat/Milk/Poultry/Eggs TGAI
Does EPA Bibliographic Must Additional Time Frame
Have Data? Citation Data be for
Submitted? Submission
97
No Yes
37 97
No — Yes
V 9/
No Yes
5/ 1,97
No — Yes
57 1,9/
No — Yes
2,6/ 1,97
No — Yes
2,77 1,97
No — Yes
2,87
No — Reserved —
-fcfc
Osl
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TABIE A
GENERIC DATA REQUIREMENTS FOR ARSENIC ACID
§158.125 Residue Chemistry - Continued
I/ It is recommended that the results of the "Nature of Residue (Metabolism)" studies in plants and animals be submitted
and found to be acceptable by the Agency prior to the development of an acceptable Analytical Method and that both
of these data requirements should be completed prior to completion of the crop field trials.
21 All residue data requested in this standard must be accompanied by data regarding storage duration and conditions
of samples analyzed. These data must be accompanied by data depicting the stability of residues of arsenic acid
(total as well as speciated arsenic) under the conditions and for the intervals specified.
3/ Data reflecting the distribution and metabolism of [T^Aslarsenic acid in cottonseed following foliar deslccant
treatment. Samples must also be analyzed using (1) Method I(d) in PAM, Vol. II (A.O.A.C. 14th Ed., § 25.041-25.04?)
to ascertain its validity for data collection and enforcement purposes, and (11) an analytical procedure capable of
speclatlng arsenic.
V Metabolism studies utilizing ruminants and poultry. Animals must be dosed for three days with [74As]arsenic acid
at a concentration in the total diet which will result in sufficient residues in the tissues, milk, and eggs for
characterization. Animals must be sacrificed within 24 hours of the final dose (milk and eggs must be collected
twice daily). 7^ As- residues must be characterized in muscle, fat, kidney, liver, milk, and eggs. Samples must
also be analyzed using (1) Method I(b) In PAM, Vol. II (A.O.A.C. 14th Ed., § 25.050-25.055) to ascertain its validity
for data collection and enforcement purposes, and (11) an analytical procedure capable of speciating arsenic.
j)/ Validated quantitative methods which are capable of speclatlng arsenic In plant and In animal tissues must be
submitted.
6/ Data depicting residues of total'arsenic and Individual arsenic species (expressed as As and as As2Ch) In or on
cottonseed harvested 4 days after a single application of the 755? SC/L at 1.5 qt./A, applied in 4 gal. water
/acre using ground equipment. Tests must be conducted In TX (30/0, CA (25%), and MS (11.556), which represent the
major U.S. cotton production regions (Agricultural Statistics, 1984, p. 62); 1983 preliminary cotton production
values for each state appear in parentheses.(Note: If this use on cotton is geographically restricted to Texas and
Oklahoma, then data from Texas only will be required.) The treatment history of the fields for the past 5 years will
be required. Two different groups of treated samples and controls will be required. One group should be known to
have been treated with an arsenical pesticide within the past 1 to 2 years; the second group should be known not to
have been treated in the past 5 years. Pretreatanent soil measurements of total arsenic and individual arsenic
species (expressed as As and as As203) must be obtained from each test site.
-------
GENERIC DATA REQUIREMENTS FOR ARSENIC ACID
§158.125 Residue Chemistry - Continued
7/ Data depicting residues of total arsenic and Individual arsenic species (expressed as As and as As2C3) In gin
trash, meal, hulls, crude and refined oil, and soapstock, processed from cottonseed bearing measurable, weathered
residues. Should residues concentrate In any of these products, appropriate food/feed additive tolerances must be
proposed.
8/ The need for studies regarding the magnitude of the residue in meat, milk, poultry, and eggs will be determined when
the requirement for livestock metabolism data has been satisfied.
9/ This data has already been requested In the arsenic acid "Data Call-in Notice" issued 2/10/86. The time frame for
submission of this data is as specified in that Notice.
cn
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TABLE A
GENERIC DATA REQUIREMENTS FOR ARSENIC ACID
Data Requirement
1
§158.130 Environmental Fate""
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis
Photodegradation
161-2 - In water
161-3 - On soil
161-4 - In Air
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
,2,3/
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Test
Substance
or PAIRA
or PAIRA
or PAIRA
or PAIRA
or PAIRA
or PAIRA
Use
Patterns
A,B
A,B
A
A
A,B
A
Does EPA Bibliographic
Have Data? Citation
No
No
No
No
No
No
Must Additional
Data be
Submitted?
V
No
5/
No
5/
No
5/
No
6/
Yes
11
Yes
Time Frame
for
Submission
27 Months
27 Months
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
ABILITY STUDIES:
TGAI or PAIRA
TGAI or PAIRA
163-1 - Leaching and TGAI or PAIRA
Adsorption/Desorption
.63-2 - Volatility (Lab)
163-3 - Volatility (Field)
TEP
TEP
N/A~
]
N/A~
A,B
A
A
li/
\
19/
No
No
No
Yes"
Yes
8,97
12 Months
12 Months
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TABLE A
GENERIC DATA REQUIREMENTS FOR ARSENIC ACID
Data Requirement
Test Use Does EPA Bibliographic
Substance Patterns Have Data? Citation
Must Additional Time Frame
Data be for
Submitted? Submission
158.130 Environmental Fate - Continued'
DISSIPATION STUDIES-FIELD:
TEP
TEP
TEP
TEP
1.2.3/
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and
Tank Mixes
164-5 - Soil, Long-term
ACCUMULATION STUDIES;
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
Organisms
165-5 - In Aquatic Non-Target
Organisms
ADDITIONAL STUDIES;
- Glovo Permeability
Study
TEP
I
PAIR,A
TEP
i
TEP
TGAI or PAIRA
TEP
TEP
A,B
N/A"
19/
N/A
197
A
A
N/A"
A,B
19/
N/A~
19/
A,B
No
No
No
No
No
No
Yes"
11,12/
13/
No
IV
17/
Yes
18/
Yes"
2? Months
Reserved —
157
Yes 39 Months
16/
Reserved —
12 Months
6 Months
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TABIE A
GENERIC DATA REQUIREMENTS FOR ARSENIC ACID
§158.130 Environmental Fate - Continued
I/ Because of the unique chemical properties of the arsenic species a complete statement of formula will be required
for each TEP. This statement must Include forms, quantities, and species of arsenic present.
2/ For all metabolism, dissipation and uptake studies, methodologies should be designed such that natural soil arsenic
may be distinguished from arsenic acid residues.
3/ Due to the non-standard nature of the data requirements to be imposed under this Registration Standard it is
strongly recommended that protocols for each study be submitted prior to initiation of the study.
V No additional data required. Arsenic acid (pure active ingredient) is chemically defined as a weak triprotic
Inorganic acid. Hydrolysis of such acids occurs as deprotonation and will occur upon mixing with water. The pK's
for the three protons are 2.25, 6.77> and 11.60. Products will be the proton and the pentavalent arsenate anion
form or a partially protonated anion depending on the system pH.
5/ No additional data required. Due to the known photochemical characteristics of the compound no useful environ-
mental fate information would be obtained from a photolysis study.
6/ Study should be designed as a confined dissipation study. A minimum of three soils will be necessary to fullflll
these requirements. At least two of the soils used in these studies must be representative of the area of use.
Data needed Include the form, availability, and rates of dissipation and/or occlusion of arsenic acid residues.
Species determination of available arsenic acid residues may be necessary.
i
]_/ Data required must define the form, availability, and rates of dissipation and occlusion of arsenic acid residues.
Additionally, data are required to determine the degree of anaerobicity (Eh) of the test system. Species
determination of available arsenio acid residues will be necessary since arsenite (As+3) formation occurs under
anaerobic conditions.
8/ Soil column leaching study required. See Subdivision N §163-1 for study specifics.
-------
GENERIC DATA REQUIREMENTS FOR ARSENIC ACID
§158.130 Environmental Fate - Continued
97 Additional study required using soils representative of the areas of arsenic acid use:
a. At least three soil core sites should be examined for background As levels before desiccant application;
b. A conservative water tracer such as chloride ion should be added to the field on the same day as the pesticide
is applied;
c. All soil cores should be taken and analyzed In continuous six Inch segments until the zone of maximum leaching
is established;
d. Arsenic acid residues at the zone of maximum leaching should be speclated and quantified.
10/ Data requirements reserved pending the results of an acceptable laboratory volatility study.
ll/ Establishment of preapplication soil background levels is required for Interpretation of this data.
12/ Speciatlon of available As residues will be necessary for determination of environmental fate of arsenic acid
residues.
13/ Data requirements for combination products and tank mix uses are not being Imposed for this Standard because no
such products or tank mix uses exist for the cotton and okra uses.
IV Data requirements are reserved pending results of aerobic soil metabolism and terrestrial field dissipation
studies.
i
157 Crops used for these studies should be representative of those that are normally rotated into arsenic acid treated
fields.
l6/ Data required unless confined study (165-1) Indicates no uptake of arsenic acid residues.
177 Baseline or background arsenic levels in test organisms must be established prior to the addition of the test
material.
18/ A glove permeability study is required. The study should be conducted in accordance with ASTM 739-81 - Standard
Test Method for Resistance of Protective Materials to Permeation by Hazardous Liquid Chemicals. It is strongly
suggested that a test protocol be submitted prior to initiation of this study.
197 Data is only required for aquatic and/or forestry use patterns, as specified in §158.130.
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TABLE A
GENERIC DATA REQUIREMENTS FOR ARSENIC ACID
Date Requirement
§138.135 Toxicology
ACUTE TESTING:
81-1 - Acute Oral Toxlclty
- Rodent
81-2 - Acute Dermal Toxiclty
- Rabbit
81-3 - Acute Inhalation Toxlclty
- Rodent
81-7 - Delayed
Test
Substance
TGAI
TGAI
TGAI
TGAI
Use
Patterns
A,B
A,B
A,B
A,B
Does EPA Bibliographic
Have Data? Citation
No
No
No
No
Must Additional
Data be
Submitted
2/
Yes
Yes
2/
Yes
V
No
Time Frame
for
Submission
9 Months
9 Months
9 Months
Neurotoxicity - Hen
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ARSENIC ACID
Date
§158.
Requirement
135 Toxicology
Test
Substance
Use
Patterns
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted
Time Frame
for
Submission
SUBCHRONIC TESTING:
82-1
82-2
82-3
82-4
82-5
- 90-Day Feeding:
- Rodent, and
- Non-rodent (Dog)
- 21-Day Dermal - Rabbit
- 90-Day Dermal - Rabbit
- 90-Day Inhalation:
- Rat
- 90-Day Neurotoxicity:
- Hen
-Maximal
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
i
A
A
A
A
A
A
A
Yes
Yes
Yes
No
No
No
Yes
00159870
00159870
00159870
00159870
No
No
No
V
No
I/
No
V
No
No
—
—
—
—
—
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ARSENIC ACID
Data Requirement
§158.135 Toxicology - Continued
CHRONIC TESTING:
83-1 - Chronic Toxicity -
2 species:
- Rodent, and
- Non-rodant (Dog)
83-2 - Oncogenicity -
2 species:
- Rat (preferred), and
- Mouse (preferred)
83-3 - Teratogenicity -
2 species:
- Rodent
- ITabbit
83-4 - Reproduction - Rodent
2-generation
MOTAGENICITY TESTING
84-2 - Gene Mutation (Ames Test)
84-2 - Structural Chromosomal
Test
Subutance
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
i
TGAI
TGAI
TGAI
Use
Patterns
A
A
A
A
A
A
A
A,B
A,B
Does EPA
Have Data?
Yes
Yes
V
Yes
V
Yes
No
No
No
Yes
Yes
Bibliographic
Citation
00159870
00159870
00159870
00159870
—
00159870
00159870
Must Additional
Data be
Submitted?
No
No
No
No
3/
Yes
Yes
2/
Yes
No
No
Time Frame
for
Submission
—
—
15 Months
15 Months
39 Months
l_» «_LTIM-
Aberration
84-U - Other Genotoxlc Effects
TGAI
A,B
Yes
00159870
No
-------
TABIE A
GENERIC DATA REQUIREMENTS FOR ARSENIC ACID
Data Requirement Test Use Does EPA Bibliographic Must Additional
Substance Pattern Have Data? Citation Data be
Submitted?
§158.135 Toxicology - Continued
SPECIAL TESTING
Time Frame
for
Submission
85-1 - General Metabolism PAI or ?AIRA A Yes 00159870 No —
85-2 - Dermal Penetration Choi
86-1 - Domestic Animal Choi
Safety
36 A No Yes
26 A Yes 00159870 No
12 Months
I/ Data base (OHEA document - 00159870) and exposure scenario do not mandate testing at this time.
2_/ A rodent species other than the rat is required since rats are known to be anomalous with respect to the
pharmacokinetics of arsenic.
3/ A mouse or hamster is required since rats are known to be anomalous with respect to the pharmacokinetics
of arsenic.
i
V Human epidemiology studies were used in place of animal studies.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ARSENIC ACID
Data Requirement
§158.140 Reentry Protection
132-1 - Foliar Dissipation
132-1 - Soil Dissipation
133-3 - Dermal Exposure
133-4 - Inhalation Exposure
§158.142 Spray Drift
201-1 - Droplet Size Spectrum
202-1 - Drift Field Evaluation
Test
Substance
TEP
TEP
TEP
TEP
TEP
TEP
Use Does EPA Bibliographic
Pattern Have Data? Citation
I/
N/A
I/
N/A
I/
N/A
I/
N/A
A,B No
A,B No
Must Additional Time Frame
Data be for
Submitted? Submission
— —
— —
— —
— —
Yes 9 Months
Yes 9 Months
I/ Substantial human exposure to the. pesticide is not likely to occur.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ARSENIC ACID
Data Requirement
§158.145 Wildlife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
70-1 - Special Test
71-1 - Acute Avian Oral Toxicity
71-2 - Avian Subacute Dietary
Toxicity
- Upland Game Bird, and
- Waterfowl
71-3 - Wild Maximal Toxicity
71-^ - Avian Reproduction
- Upland Game Bird, and
- Waterfowl
71-5 - Simulated Field Testing
- Manuals, and
- Birds
- Actual Field Testing
- Mammals, and
- Birds
Test
Substance
TEP
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
i
TEP
TEP
TEP
TEP|
Use
Pattern
A
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
Does EPA Bibliographic
Have Data? Citation
No
No
Yes 00121618
Partial 00106855
No
No —
No
No
No
No
No
Must Additional
Data be
Submitted?
I/
Yes
Yes
No
11
Yes
No
No
No
No
I/
Reserved
No
I/
Reserved
Time Frame
for
Submission
16 Months
9 Months
—
9 Months
—
—
—
—
—
—
—
ui
LTI
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ARSENIC ACID
Data
§158
Requirement
.145 Wildlife and
Test Use Does EPA Bibliographic Must Additional Time Frame
Substance Pattern Have Data? Citation Data be for
Submitted? Submission
Aquatic Organisms - Continued
AQUATIC ORGANISM TESTING
72-1
72-2
72-3
72-4
- Freshwater Fish Toxic ity
- Coldwater Fish Species,
and
- Warrowater Fish Species
- Acute Toxicity to
Freshwater Invertebrates
- Acute Toxicity to
Estuarine and Marine
Organisms
- Fish
- Mollusk
- Shrimp
- Fish Early Life Stage
Aquatic Invertebrate
TGAI A,B Yes GS0389-002 No
2/
TGAI A,B Partial 00119999 Yes 9 Months
TGAI A,B Yes GS0389-003 No
V
TGAI A No — Reserved
V
TGAI A No — Reserved
V
TGAI A No — Reserved —
5/
TGAI N/A No No
5/
TGAI A No — Yes 15 Months
Life Cycle
72-5 - Fish - Life-Cycle
TGAI
No
Reserved"
6/
-------
GENERIC DATA REQUIREMENTS FOR ARSENIC AC1U
Data
§158
72-6
Requirement
.145 Wildlife and
Aquatic Organisms
- Aquatic Organism
Accumulation
- Crustacean
- Fish
- Insect Nymph
- Mollusk
Test
Substance
- Continued
TGAI
TGAI
TGAI
TGAI
Use Does EPA
Pattern Have Data?
A No
A No
A No
A No
Bibliographic
Citation
Must Additional Time Frame
Data be for
Submitted? Submission
Reserved"
i/
Reserved — —
I/
Reserved — —
6/
Reserved — —
72-7 - Simulated Field Testing
- Aquatic Organisms TEP
- Actual Field Testing
- Aquatic Organisms TEP
A
A
No
No
6/
Reserved"
6/
Reserved"
Ln
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ARSENIC ACID
§158.1*15 Wildlife and Aquatic Organisms - Continued
i
I/ Residue monitoring field study on avian food items associated with cotton fields in Texas. Carcasses should be
recorded when found. Pood items tested should include grasses, forbs (such as, buttonweed, doveweed and ruellia),
seed-producing plants and dead Insects. Protocols must be submitted within 3 months.
2/ This study may be repaired by submission of missing data/information: dissolved oxygen and pH values during the test;
data on negative controls; and 96-hour mortality data. If these data cannot be supplied, a new study is required in
order to fulfill this data requirement.
3/ Studies may be required upon receipt of avian acute oral ID50 and the Special Test (70-1 described in footnote 1).
V Testing on marine organisms is reserved pending receipt of acute freshwater fish testing results (72-1).
5/ Chronic testing on freshwater aquatic species is being required because the estimated environmental concentration in
water exceeds 0.01 the LC50. Only the aquatic Invertebrate life cycle test is being required because acute toxicity
data indicate that the aquatic invertebrates are more sensitive than fish to arsenic acid.
6/ Test reserved pending outcome of the aquatic invertebrate life cycle test.
7_/ Addition of arsenic acid to the diet resulted In food aversion in the submitted study. Either a repellency test,
using treated diet and untreated nonpreferred food as choices, or an additional dietary study using another species
of waterfowl must be performed.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ARSENIC ACID
Data Requirement Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation
§158.150
121-1 -
Plant Protection
TARGET AREA EP A,B No
PHYTOTOXICITY
Must Additional Time Frame
Data be for
Submitted? Submission
No
NONTARGET AREA PHYTOTOXICITY
122-1 -
122-1 -
122-2 -
123-1 -
123-1 -
123-2 -
1211-1 -
124-2 -
TIER I
i
Seed Germination/ TQA'i B No —
Seedling Emergence
Vegetative Vigor TGAI B No
Aquatic Plant Growth TGAI B No —
TIER II
Seed Germination/ TGAI B No —
Seedling Emergence '
Vegetative Vigor TGAI B No
Aquatic Plant Growth TGAI B No —
TIER III
Terrestrial Field TEP B No —
Aquatic Field TEP B No
2/
No
2/
No
2/
No
3/
No
3/
No
3/
No
3/
No
3/
No
ui
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ARSENIC ACID
§158.150 Plant Protection
I/ These data are only required when target area phytotoxicity is one of the issues involved in initiating the Special
Review.
2/ Data requirement is not relevant to the okra use.
3/ Test is not required because corresponding lower tier tests are not required.
-------
GENERIC DATA REQUIREMENTS FOR ARSENIC ACID
Data Requirement
Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
§158.155 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORS;
141-1 - Hone.; bee acute TGAI A,B
contact toxicity
141-2 - Honey bee - toxicity TEP A,B
of residues on
foliage
141-4 - Honey bee subacute (Reserved)"
feeding study
141-5 - Field testing for TEP A,B
pollinators
NONTARGET INSECT TESTING -
AQUATIC INSECTS:
2/
142-1 - Acute toxicity to (Reserved)"
aquatic insects
142-2 - Aquatic insect (Reserved)"
life-cycle study
142-3 - Simulated or actual (Reserved)"
field testing for
aquatic insects
143-1 - NONTARGET INSECT (Reserved)"
thru TESTING - PREDATORS
143-3 AND PARASITES
3/
3/
3/
3/
No
No
Yes
J
Reserved
9 Months
I/
No
Reserved
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ARSENIC ACID
§158.155 Nontarget Insect
I/ Requirement reserved pending receipt of results from Honeybee acute contact study.
2/ Reserved pending development of test methodology.
3/ Reserved pending Agency decision as to whether the data requirement should be established.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR.MANUFACTURING-USE PRODUCTS CONTAINING ARSENIC ACID
Data Requirement
Test Use Does EPA Bibliographic
Substance Pattern Have Data?!/ Citation!/
Materials and
Manufacturing Process
61-3 - Discussion of Formation MP
of Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis MP
i
62-2 - Certification of Limits MP
62-3 - Analytical Methods to Verify MP
Certified Limit
Physical and Chemical Characteristics
63-2 - Color MP
63-3 - Physical State MP
63-4 - Odor MP
All
All
All
All
All
All
All
No
No
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Must Additional Time Frame
Data be for
Submitted? Submission
§158.120 Product Chemistry
Product Identity:
61-1 - Product Identity and MP All No N/A
Disclosure of
Ingredients
61-2 - Description of Beginning MP All No N/A
I/
Yes 6 Months
2/
Yes 6 Months
Yes
Yes
Yes
Yes
Yes
Yes
Yes
6 Months"
2/
12 Months
12 Months
12 Months
6 Months
6 Months
6 Months
04
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING ARSENIC ACID
Data
§158.
Requirement
Test
Substance
Use.
Pattern
Does EPA Bibliographic Must Additional Time Frame
Have Data?!/ Citation!/ Data be for
Submitted? Submission
120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-7
63-12
63-14
63-15
63-16
63-17
63-18
63-19
63-20
Other
64- 1
- Density, Bulk Density, or
Specific Gravity
- pH
- Oxidizing or Reducing
Action
- Flammabllity
- Explodability
- Storage Stability
- Viscosity
- Miscibllity
- Corrosion Characteristics
Requirements :
- Submittal of samples
MP
MP
MP
MP
MP
MP
iMP
MP
i
MP
MP
All
All
All
All
All
All
All
All
All
All
No
No
No
No
No
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
7 Months
7 Months
7 Months
7 Months
7 Months
16 Months
7 Months
7 Months
7 Months
7 Months
I/ Not applicable. Although product chemistry data may have been submitted in the past, the Agency has determined that
these data must be resubmitted for each manufacturing use product. New requirements have been Introduced and
previously submitted data must be updated. Therefore bibliographic citations for the old data are not applicable.
2/ From the date of receipt of the Data Call-in Notice for* arsenic acid issued 2/1O/86.
-------
TABI£ B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING ARSENIC ACID
Data Requirement Test Use Does EPA Bibliographic! Must Additional
Substance Pattern Have Data? Citation Data be
Submitted?
§158.135 Toxicology
ACUTE TESTING
I/
81-1 - Acute Oral Toxicity - Rodent MP A,B No — Yes
81-2 - Acute Dermal Toxicity MP A,B No — Yes
- Rabbit
I/
81-3 - Acute Inhalation Toxicity MP A,B No — Yes
- Rodent
81-4 - Primary Eye MP A,B No — Yes
Irritation - Rabbit
81-5 - Primary Dermal MP A,B No — Yes
Irritation - Rabbit
81-6 - Dermal Sensitization - MP A,B No — Yes
Guinea Pig
i
I/ A rodent species other than the rat. is required since rats are known to be anomalous with respect to the
pharmacoklnetics of arsenic.
ON
LD
Time Frame
for
Submission
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
-------
II. LABELING APPENDICES
66
-------
SUMMARY-1
LABEL CONTENTS
40 CPR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it Is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. [40 CPR I62.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required Identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency.
[40 CPR I62.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the_final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
[40 CPR I62.10(f)]
Item 6A. INGREDIENTS STATEMENT - An Ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. [40 CPR l62.10(g)]
67
-------
SUMMARY-2
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. [40 CFR I62.10(h)(1)(11)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel Immediately below
the child hazard warning statement. [40 CFR 162.10 (h)(l)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation toxicity, the word "Poison" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. [40 CFR I62.10(h)(1)(i)]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I
II, and III. [40 CFR I62.10(h)(1)(ill)]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel
[40 CFR I62.10(h)(l)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back*
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR 162.10(h)(2)].
68
-------
SUMMARY-3
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CPR I62.10(h)(2)(1)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CPR I62.10(h)(2)(11)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - PLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria
in the PHYS/CHEM Labeling Appendix. The requirement Is
based on the results of the flashpoint determinations and
flame extension tests required to be submitted for all products.
These statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no signal word is
used in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - PIPRA sec. 3(d)
requires that all pesticide formulations/uses be classified
for either general or restricted use. Products classified
for restricted use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of ko CPR 162.11 (c). You will be notified ol'
the Agency's classification decision.
69
-------
SUMMARY-4
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size
as required for human hazard signal word (see table in 40
CPR
b. Directly below this statement on the front panel,
a summary statement of the terms of restriction must
appear (including the reasons for restriction if specified
in Section I). If use is restricted to certified applicators,
the following statement is required: "For retail sale
to and use only by Certified Applicators or persons
under their direct supervision and only for those uses
covered by the Certified Applicator's Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label uses that
are unrestricted, but you may not distinguish them
on the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that -the products will be assigned
separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
70
-------
SUMMARY-5
Item 10A. REENTRY STATEMENT - If a reentry interval
has been established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix II,
STOR, PEST/DIS, and CONT/DIS to determine the storage and
disposal instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by .
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment.
[40 CPR 162.10]
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from those
accepted in connection with registration of the product. It
should be made part of the response to this notice and submitted
for review.
71
-------
SUMMARY-6
LABELING REQUIREMENTS OP THE FIFRA, AS AMENDED
ITEM
1
2
3
H
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OP REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit'area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
Fhiib'iiHKhJj
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
Immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Inmediately
below child
hazard
warning
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of .
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
•Note type size requirements.
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SUMMARY-?
ITEM
70
7D
7E
8
8A
BB
LABEL ELEMENT
Skull & cross-
bones and word
POISON (In red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OP REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others :
Grouped with
side panel
precautionary
statements .
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
v
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
Osl
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SUMMARY-8
ITEM
Be
9A
9B
10A
10B
IOC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OP REQUIREMENT
All pressurized
products, others
with flash
points under
150°P
All restricted
products
All products
PR Notice «3-2
or as determined
by the Agency
All products
All products
i
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFEPKK.h
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Required statement is:
"It is a violation of Federal law
to use this product in a manner
Inconsistent with its labeling."
Must be set apart and clearly distin-
guishable from from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
-------
§ 162.10 Labeling requirements.
(a) General—(1) Contents of the
label Every pesticide products shall
bear a label containing the informa-
tion specified by the Act and the regu-
lations in this Part. The contents of a
label must show clearly and promi-
nently the following:
44) The name, brand, or trademark
under which the product is sold as pre-
scribed in paragraph (b) of this sec-
tion;
(ii) The name and address of the
producer, registrant, or person for
whom produced as prescribed in para-
graph (c) of this section;
(iii) The net contents as prescribed
in paragraph (d) of this section;
(iv) The product registration
number as prescribed in paragraph (e)
of this section;
75
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Environmental Protection Agency
(v) The producing establishment
number as prescribed in paragraph (f)
of this section;
(vi) An ingredient statement as pre-
scribed in paragraph (g) of this sec-
tion;
(vii) Warning or precautionary state-
ments as prescribed in paragraph (h)
of this section;
(viii) The directions for use as pre-
scribed in paragraph (i) of this section;
and
(ix) The use classification(s) as pre-
scribed in paragraph (j) of this section.
(2) Prominence and legibility, (i) All
words, statements, graphic representa-
tions, designs or other information re-
quired on the labeling by the Act or
the regulations in this part must be
clearly legible to a person with normal
vision, and must be placed with such
conspicuousness (as compared with
other words, statements, designs, or
graphic matter on the labeling) and
expressed in such terms as to render it
likely to be read and understood by
the ordinary individual under custom-
ary conditions of purchase and use.
(ii) All required label text must:
(A) Be set in 6-point or larger type;
(B) Appear on a clear contrasting
background; and
(C) Not be obscured or crowded.
(3) Language to be used. All required
label or labeling text shall appear in
the English language. However, the
Agency may require or the applicant
may propose additional text in other
languages as is considered necessary to
protect the public. When additional
text in another language is necessary,
all labeling-requirements will be ap-
plied equally to both the ISnglteh and
other-language versions of the label-
ing.
(4) Placement of Label—
-------
§ 162.10
40 CFR Ch. I (7-1-85 Edition)
ingredients if the name suggests one
or more but not all such principal
active ingredients even though the
names of the other ingredients are
stated elsewhere in the labeling;
(vii) A true statement used in such a
way as to give a false or misleading im-
pression to the purchaser;
(viii) Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions;
(ix) Claims as to the safety of the
pesticide or its ingredients, including
statements such as "safe," "nonpoison-
ous," "noninjurious," "harmless" or
"nontoxic to humans and pets" with
or without such ^qualifying phrase as
"when used as directed"; and
(x) Non-numerical and/or compara-
tive statements on the safety of the
product, including but not limited to:
(A) "Contains all natural ingredi-
ents";
(B) "Among the least toxic chemi-
cals known"
(C) "Pollution approved"
(6) Final printed labeling, (i) Except
as provided in paragraph (a)(6)(ii) of
this section, final printed labeling
must be submitted and accepted prior
to registration. However, final printed
labeling need not be submitted until
draft label texts have been provision-
ally accepted by the Agency.
(ii) Clearly legible reproductions or
photo reductions will be accepted for
unusual labels such as those silk-
screened directly onto glass or metal
containers or large bag or drum labels.
Such reproductions must be of micro-
film reproduction quality.
(b) Name, brand, or trademark. (1)
The name, brand, or trademark under
which the pesticide product is sold
shall appear on the front panel of the
labeL
(2) No name, brand, or trademark
may appear on the label which:
(1) Is false or Tnislfwting, or
(ii) Has not been approved by the
Administrator through registration or
supplemental registration as an addi-
tional name pursuant to S 162.
-------
Environmental Protection Agency
or endorsement of the product by the
Agency.
(f) Producing establishments regis-
tration number. The producing estab-
lishment registration number preced-
ed by the phrase "EPA Est.", of the
final establishment at which the prod-
uct was produced may appear in any
suitable location on the label or imme-
diate container. It must appear on the
wrapper or outside container of the
package if the EPA establishment reg-
istration number on the immediate
container cannot be clearly read
through such wrapper or container.
(g) Ingredient statement—<1) Gener-
al. The label of each pesticide product
must bear a stafenTent which contains
the name and percentage by weight of
each active ingredient, the total per-
centage by weight of all inert ingredi-
ents; and if the pesticide contains ar-
senic in any form, a statement of the
percentages of total and water-soluble
arsenic calculated as elemental ar-
senic. The active ingredients must be
designated by the term "active ingredi-
ents" and the inert ingredients by the
term "inert ingredients," or the singu-
lar forms of these terms when appro-
priate. Both terms shall be in the
same type size, be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" is
not required for pesticides which con-
tain 100 percent active ingredients.
Unless the ingredient statement is a
complete analysis of the pesticide, the
term "analysis" shall not be used as a
heading for the ingredient statement.
(2) Position of ingredient statement
(i) The ingredient statement is nor-
mally required on the front panel of
the labeL If there is an outside con-
tainer or wrapper through which the
ingredient statement cannot be clearly
read, the ingredient statement must
also appear on such outside container
or wrapper. If the size or form of the
package makes it impracticable to
place the ingredient statement on the
front panel of the label, permission
may be granted for the ingredient
statement to appear elsewhere.
(ii) The text of the ingredient state-
ment must run parallel with other
text on the panel oh which it appears,
and must be clearly distinguishable
§ 162.10
from and must not be placed in the
body of other text.
(3) Names to be used in ingredient
statement. The name used for each in-
gredient shall be the accepted
common name, if there is one, fol-
lowed by the chemical name. The
common name may be used alone only
if it is well known. If no common name
has been established, the chemical
name alone shall be used. In no case
will the use of a trademark or proprie-
tary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of Section 25(c)(6).
(4) Statements of percentages. The
percentages of ingredients shall be
stated in terms of weight-to-weight.
The sum of percentages of the active
and the inert ingredients shall be 100.
Percentages shall not be expressed by
a range of values such as "22-25%." If
the uses of the pesticide product are
expressed as weight of active ingredi-
ent per unit area, a statement of the
weight of active ingredient per unit
volume of the pesticide formulation
shall also appear in the ingredient
statement.
(5) Accuracy of stated percentages.
The percentages given shall be as pre-
cise as possible reflecting good manu-
facturing practice. If there may be un-
avoidable variation between manufac-
turing batches, the value stated for
each active ingredient shall be the
lowest percentage which may be
present.
(6) Detcricrzticx. Pesticides which
change in chemical composition sig-
nificantly must meet the following la-
beling requirements:
(i) In cases where It is determined
that a pesticide formulation changes
chemical composition significantly,
the product must bear the following
statement in a prominent position on
the label: "Not for sale or use after
[date]."
(ii) The product must meet all label
claims up to the expiration time indi-
cated on the labeL
(7) Inert ingredients. The Adminis-
trator may require the name of any
inert ingredients) to be listed in the
ingredient statement if he determines
that such ingredient(s) may pose a
hazard to man or the environment.
78
-------
§ 162.10
40 CFR Ch. I (7-1-85 Edition)
(h) Warnings and precautionary
statements. Required warnings and
precautionary statements concerning
the general areas of lexicological
hazard including hazard to children,
environmental hazard, and physical or
chemical hazard fall into two groups;
those required on the front panel of
the labeling and those which may
appear elsewhere. Specific require-
ments concerning content, placement,
type size, and prominence are given
below.
(1) Required front panel statements.
With the exception of the child
hazard warning statement, the text re-
quired on the front panel of the label
is determined by the Toxicity CategOr
ry of the pesticide. The category is as-
signed on the basis of the highest
hazard shown by any of the indicators
in the table below:
Hazard indicators
Oral ID*
Inhalation 1C.
Dermal ID-
Eye effects
SMfi tftoct* ,
Toxicity categories
1
Up to and including 50
mg/kg.
UpTO-anehincludmg 2
mg/Her.
Up to and including 200
mg/kg.
Corrosive; comeaJ
opacity not reversible
wilhm 7 days.
Gofmnvft i
II
From 50 thru 500 mg/kg..
From 3. thru 2 mg/liter__.
From 200 thru 2000
ComeaJ opacity
reversible within 7
days; irritation
persisting for 7 days.
Severe irritation at 72
hours.
Ill
From 500 thru 5000 mg/
kg.
From 2. thru 20 mg/«er_
From 2.000 thru 20.000_
No oorneal opacity;
irritation raversMe
within 7 days.
Moderate irritation at 72
hours.
IV
Greater than 5000 mg/
kg..
Greater than 20 mg/fiter.
Greater than 20.000.
No irritation.
Mild or slight irritation at
72 hours.
(i) Human hazard signal word—(A)
Toxicity Category L All pesticide prod-
ucts meeting the criteria of Toxicity
Category I shall bear on the front
panel the signal word "Danger." In ad-
dition if the product was assigned to
Toxicity Category I on the basis of its
oral. Inhalation or dermal toxicity (as
distinct from skin and eye local ef-
fects) the word "Poison" shall appear
in red on a background of distinctly
contrasting color and the skull and
crossbones shall appear in Immediate
proximity to the word "poison."
(B) Toxicity Category II. All pesti-
cide products meeting the criteria of
Toxicity Category n shall bear on the
front panel the signal word "Warn-
ing."
(C) Toxicity Category III. All pesti-
cide products meeting the criteria of
Toxicity Category m shall bear on
the front panel the signal word "Cau-
tion."
(D) Toxicity Category IV. All pesti-
cide products meeting the criteria of
Toxicity Category IV shall bear on the
front panel the signal word "Caution."
(E) Use of signal words. Use of any
signal word(s) associated with a higher
Toxicity Category is not permitted
except when the Agency determines
that such labeling is necessary to pre-
vent unreasonable adverse effects on
man or the environment. In no case
shall more than one human hazard
signal word appear on the front panel
of a label.
(ii) Child hazard warning. Every pes-
ticide product label shall bear on the
front panel the statement "keep out of
reach of children." Only in cases
where the likelihood of contact with
children during distribution, market-
ing, storage or use is demonstrated by
the applicant to be extremely remote,
or I/ the nature of the pesticide Is such
that it Is approved for use on infants
or small children, may the Administra-
tor waive this requirement.
(ill) Statement of practical treat-
ment—
-------
Environmental Protection Agency
§ 162.10
front panel near the word "Poison"
and the skull and crossbones.
(B) Other toxicity categories. The
statement of practical treatment is not
required on the front panel except as
described in paragraph (hXIXiiiXA) of
this section. The applicant may. how-
ever, include such a front panel state-
ment at his option. Statements of
practical treatment are, however, re-
quired elsewhere on the label in
accord with paragraph (hX2) of this
section if they do not appear on the
front panel.
(iv) Placement and prominence. All
the require front panel warning state-
ments shall Ire grouped together on
the label, and shall appear with suffi-
cient prominence relative to other
front panel text and graphic material
to make them unlikely to be over-
looked under customary conditions of
purchase and use. The following table
shows the minimum type size require-
ments for the front panel warning
statements on various sizes of labels:
Size of label front panel in square
inches
5 And under —
Above 5 to 10 ..... ••••" —
Above 10 to IS
Above 15 to 30
Ovor 30
Points
Required
signal
word. «H
capitals
6
10
12
14
18
"Keep out
at reach of
children"
6
6
8
10
12
(2) Other required warnings and pre-
cautionary statements. The warnings
and precautionary statements as re-
quired below shall appear together on
the label under the general heading
"Precautionary Statements" and
under appropriate subheadings of
"Hazard to Humans and Domestic Ani-
mals/' "Environmental Hazard" and
"Physical or Chemical Hazard."
(i) Hazard to humans and domestic
animals. (A) Where a hazard exists to
humans or domestic animals, precau-
tionary statements are required indi-
cating the particular hazard, the
route(s) of exposure and the precau-
tions to be taken to avoid accident,
injury or damage. The precautionary
paragraph shall be immediately pre-
ceded by the appropriate hazard signal
word.
(B) The following table depicts typi-
cal precautionary statements. These
statements must be modified or ex-
panded to reflect specific hazards.
Toxicity
category
Precautionary statements by toxicity category
Oral, inhalation, or dermal Unddty
Skin and eye local effects
HI.
IV.
Fatal (poisonous) H swallowed [inhaled or absorbed
through skin]. Do not breathe vapor [dust or spray
mist]. Do not get In eyes, on skin, or on clothing
[Front panel statement of practical treatment re-
quired.].
May to fatal if swallowed [Inhaled or absorbed
through the sMnl. Do not breathe vapors [dust or
spray mist]. Do not get in eyes, 'on skin, or on
clothing. [Appropriate first aid statements required.}.
Harmful If swallowed [Inhaled or absorbed through the
skin]. Avoid breathing vapors [dust or spray mist].
Avoid contact wNh skin (eyes or clothing]. [Appro-
priate first aid statement requiredj.
[No precautionary stateme
Corrosive, causes eye and skin damage (or skin
irritation]. Op not get in •yes. on skin, or on
clothing. Wear goggles .or face shield and rubber
gloves when handBng. Harmful or fatal M swallowed.
(Appropriate first aid statement required.]
Causes eye (and skin] irritation. Do not get in ayes.
onskjn. or on clothing. Harmful If swallowed. (Ap-
propriete first aid statement required.]
Avoid contact with skin, eyes or clothing, hi case of
contact hnmadMely flush eyas or sfcbi with plenty of
(Not
uired.]
(ii) Environmental hazards. Where a
hazard exists to non target organisms
excluding humans and domestic ani-
mals, precautionary statements are re-
quired stating the nature of the
hazard and the appropriate precau-
tions to avoid potential accident,
injury or damage. Examples of the
hazard statements and the circum-
80
-------
§ 162.10
40 CFR Ch. I (7-1-65 Edition)
stances under which they are required
follow:
(A) If a pesticide intended for out-
door use contains an active ingredient
with a mammalian acute oral LDM of
100 or less, the statement "This Pesti-
cide is Toxic to Wildlife" is required.
(B) If a pesticide intended for out-
door use contains an active ingredient
with a fish acute LCM of 1 ppm or less,
the statement "This Pesticide is Toxic
to Fish" is required.
(C) If a pesticide intended for out-
door use contains an active ingredient
with an avian acute oral LDM of 100
mg/kg or less, or a subacute dietary
LCso of 500 ppm or less, the statement
"This Pesticide_is Toxic to Wildlife" is
required. ~ "~
(D) If either accident history or field
studies demonstrate that use of the
pesticide may result in fatality to
birds, fish or mammals, the statement
"This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) For uses involving foliar applica-
tion to agricultural crops, forests, or
shade trees, or for mosquito abate-
ment treatments, pesticides toxic to
pollinating insects must bear appropri-
ate label cautions.
(F) For all outdoor uses other than
aquatic applications the label must
bear the caution "Keep out of lakes,
ponds or streams. Do not contaminate
water by cleaning of equipment or dis-
posal of wastes."
(iii) Physical or chemical hazards.
Warning statements on the flammabil-
ity or explosive characteristics of the
pesticide are required as follows:
Flash point
Required text
(A) PRESSURIZED CONTAINERS
Rash point at or below 20* F; if there is a flashback at
any valve opening.
Rash point above 20* F and not over 80' F or Jf the
flame extension is more than 18 in long at a distance
of 6 in from the flame.
All other pressurized containers
Extremely flammable. Contents under pressure. Keep away from
fire, sparks, and heated surfaces. Do not puncture or incinerate
container. Exposure to temperatures above 130* F may cause
bursting.
Flammable. Contents under pressure. Keep away from heat,
sparks, and open flame. Do not puncture or Incinerate container.
Exposure to temperatures above 130* F may cause bursting.
Contents under pressure. Oo not use or store near heat or open
flame. Oo not puncture or incinerate container. Exposure to
temperatures above 130* F may cause bursting.
(B) NONPRESSURIZEO CONTAINERS
At or below 20* F..
Above 20' F and not over 80* F__
Above 80- F and not over 150' F.
Extremely flammable. Keep away from fire, sparks, and heated
surfaces.
Flammable. Keep away from heat and open flame.
Oo not use or store near heat or open flame.
(i) Directions for Use—(1) General
requirements—(i) Adequacy and clar-
ity of directions. Directions for use
must be stated in terms which can be
easily read and understood by the av-
erage person likely to use or to super-
vise the use of the pesticide. When fol-
lowed, directions must be adequate to
protect the public from fraud and
from personal injury and to prevent
unreasonable adverse effects on the
environment.
(ii) Placement of directions for use.
Directions may appear on any portion
of the label provided that they are
conspicuous enough to be easily read
by the user of the pesticide product.
Directions for use may appear on
printed or graphic matter which ac-
companies the pesticide provided that:
(A) If required by the Agency, such
printed or graphic matter is securely
attached to each package of the pesti-
cide, or placed within the outside
wrapper or bag;
(B) The label bears a reference to
the directions for use in accompanying
leaflets or circulars, such as "See di-
rections in the enclosed circular:" and
(C) The Administrator determines
that it is not necessary for such direc-
tions to appear on the label.
(iii) Exceptions to requirement for
direction for use—
-------
Environmental Protection Agency
§ 162.10
for use only by manufacturers of prod-
ucts other than pesticide products in
their regular manufacturing processes.
provided that:
(.1) The label clearly shows that the
product is intended for use only in
manufacturing processes and specifies
the type(s) of products involved.
(2) Adequate information such as
technical data sheets or bulletins, is
available to the trade specifying the
type of product involved and its
proper use in manufacturing process-
es;
(3) The product will not come into
the hands of the general public except
after incorporation into finished prod-
ucts; and
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(B) Detailed directions for use may
be omitted from the labeling of pesti-
cide products for which sale is limited
to physicians, veterinarians, or drug-
gists, provided that:
(1) The label clearly states that the
product is for use only by physicians
or veterinarians;
(2) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment; and
(J) The product is also a drug and
regulated under the provisions of the
Federal Food, Drug and Cosmetic Act.
(C) Detailed directions for use may
be omitted from the labeling of pesti-
cide products which are intended for
use only by formulators in preparing
pesticides for sale to the public, pro-
vided that:
(.1) There is information readily
available to the formulators on the
composition, toxicity, methods of use,
applicable restrictions or limitations,
and effectiveness of the product for
pesticide purposes;
<2) The label clearly states that the
product Is intended for use only in
manufacturing, formulating,
or repacking for use as a pesticide and
specifies the type(s) of pesticide prod-
ucts involved;
(J) The product as finally manufac-
tured, formulated, mixed, or repack-
aged is registered; and
The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(2) Contents of Directions for Use.
The directions for use shall include
the following, under the headings "Di-
rections for Use":
(i) The statement of use classifica-
tion as prescribed in 162.10(j) immedi-
ately under the heading "Directions
for Use."
(il) immediately below the state-
ment of use classification, the state-
ment "It is a violation of Federal law
to use this product in a manner incon-
sistent with its labeling."*
(iii) The site(s) of application, as for
example the crops, animals, areas, or
objects to be treated.
(iv) The target pest(s) associated
with each site.
(v) The dosage rate associated with
each site and pest.
(vi) The method of application, in-
cluding instructions for dilution, if re-
quired, and type(s) of application ap-
paratus or equipment required.
(vli) The frequency and timing of ap-
plications necessary to obtain effective
results without causing unreasonable
adverse effects on the environment.
(viii) Specific limitations on reentry
to areas where the pesticide has been
applied, meeting the requirements
concerning reentry provided .by 40
CFR Part 170.
(ix) Specific directions concerning
the storage and disposal of the pesti-
cide and its container, meeting the re-
quirements of 40 CFR Part 165. These
instructions shall be grouped and
appear under the heading "Storage
and Disposal." This heading must be
set in type of the same minimum sizes
as required for the child hazard warn-
ing. (See Table in § 162.10
(x) Any limitations or restrictions on
use required to prevent unreasonable
adverse effects, such as:
(A) Required intervals between ap-
plication and harvest of food or feed
crops.
(B) Rotational crop restrictions.
(C) Warnings as required against use
on certain crops, animals, objects, or
in or adjacent to certain areas.
(D) [Reserved]
82
-------
§162.11
40 CFR Ch. I (7-1-85 Edition)
(E) For restricted use pesticides, a
statement that the pesticide may be
applied under the direct supervision of
a certified applicator who is not phys-
ically present at the site of application
but nonetheless available to the
person applying the pesticide, unless
the Agency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who is physically present.
(P) Other pertinent information
which the Administrator determines
to be necessary for the protection of
man and the environment.
(j) Statement of Use Classification.
By October 22,1976, all pesticide prod-
ucts must beat on their labels a state-
ment of use classification as described
in paragraphs (j) (1) and (2) of this
section. Any pesticide product for
which some uses are classified for gen-
eral use and others for restricted use
shall be separately labeled according
to the labeling standards set forth in
this subsection, and shall be marketed
as separate products with differen-
registration numbers, one bearing di-
rections only for general use(s) and
the other bearing directions for re-
stricted use(s) except that, if a product
has both restricted use(s) and general
use(s), both of these uses may appear
on a product labeled for restricted use.
Such products shall be subject to the
provisions of § 162.10
-------
Criteria
PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Required Label Statement
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. All Other Pressurized
Containers
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
84
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STOR-1
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading:
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL."
Storage Instructions;
All product labels are required to have appropriate storage
instructions. Specific storage Instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide J.s leaking or has been
spilled, and precautions to minimTze exposure if damage occurs
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
85
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CONT/DIS-1
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. Domestic use products must bear one of the following
container disposal statements:
Container Type Statement
Non-aerosol products
(bottles, cans, Jars)
Non-aerosol products
(bags)
Aerosol products
Do not reuse container (bottle, can, Jar).
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
2. All other products must bear container disposal instructions
based on container type, listed below:
Container Type
Statement
Metal
containers
(non-aerosol)
Plastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Completely empty liner by shaking and
tapping -sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused1, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wording)
£/ Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
86
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III. USE INDEX APPENDIX
87
-------
EPA Compendium of Acceptable Uses
006801 ARSENIC ACID*
TYPE PESTICIDE; Desiccant (Refer also to Fungicide entry for wood
preservatives)
FORMULATIONS; SC/L (15.7 Ib/gal or 75% a.i., 75%)
GENERAL WARNINGS AND LIMITATIONS: RESTRICTED USE PESTICIDE. For retail
sale to and use only by certified applicators or persons under their di-
rect supervision, and only for those uses covered by the certified appli-
cator's certification. Arsenic acid is used as a preharvest desiccant in
(stripper harvested) cotton and in okra grown for seed. Apply on clear
days when the average temperature is 80 F (26.7 C) or higher. Do not use
in galvanized metal containers or spray equipment, as highly toxic arsine
gas may be formed. Avoid spray drift to desirable plants or to areas and
buildings occupied by humans, animals, or poultry. Do not graze or use
treated plants or gin trash for food or forage. This pesticide is toxic
to wildlife. Do not apply directly to water or wetlands (swamps, bogs,
marshes and potholes). Do not contaminate water by cleaning of equipment
or disposal of wastes. When mixing/loading or otherwise handling the
concentrate wear midforearm to elbow length chemical resistant gloves,
chemical resistant shoes or boots, goggles or face shield, and a protec-
tive suit which has long sleeves and long pants. When applying the di-
luted spray solution wear a protective suit which has long sleeves and
long pants, chemical resistant gloves, and chemical resistant shoes or
boots. The protective suit must be worn over normal work clothes. When
applying the dilute spray from an enclosed aircraft cockpit or enclosed
tractor cab wear an uncontaminated long sleeve shirt and long pants. Any
article of clothing worn while applying product must be cleaned before
reusing. Launder work clothes separately from household articles.
Clothing which has been drenched or heavily contaminated should be dis-
posed of in accordance with state or local regulations.
The use of any pesticide in a. manner that may kill or otherwise harm an
endangered or threatened species or adversely modify their habitat is a
violation of federal laws. The use of this product is controlled to pre-
vent death or harm to endangered or threatened species that occur in the
following counties or elsewhere in their range. Before using this pesti-
cide in the following counties, you must obtain the Cropland Endangered
Species Bulletin (EPA/ES-CROP). The use of this pesticide is prohibited
in these counties unless specified otherwise in the Bulletin. The EPA
Bulletin is available from either your County Agricultural Extension
Agent, the Endangered Species Specialist in your State Wildlife Agency
Headquarters or the appropriate Regional Office of the U.S. Environmental
Protection Agency (EPA). THIS BULLETIN MUST BE REVIEWED PRIOR TO PESTI-
CIDE USE. ~~
SPECIES STATE COUNTY
Attwater's Greater Prairie TX Fort Bend, Refugio and Victoria
Chicken
*orthoarsenic acid
Issued: 5-27-86 1-006801-1
Provisional Update: 8-22-86
-------
EPA Compendium of Acceptable Uses
ARSENIC ACID
GENERAL WARNINGS AND LIMITATIONS (continued)
Bee Caution:
Arsenic acid is highly toxic to bees exposed to direct treatment or resi-
dues on blooming crops or weeds. Do not apply this product or allow it
to drift to blooming crops or weeds if bees are visiting the treated area.
TIME REQUIRED FOR CONTROL; Four to 10 days.
PHYTOTOXICITY TO CROPS: Kills leaves rapidly and eliminates leaf re-
growth.
MODE-OF ACTION; Reacts with proteins, causing denaturation of protoplasm.
Inactivates enzymes and decreases rate of respiration.
PLANT REGULATOR CLAIMS :
Desiccant
Issued: 5-27-86 1-006801-2 Q
07
-------
EPA Compendium of Acceptable Uses
ARSENIC ACID
'.007AA
Site, Dosage
and Formulation
(Ib a.i./A)
TERRESTRIAL FOOD CROP
(Agricultural Crops)
Cotton
Tolerance, Use, Limitations
4.0 ppm (cotton, seed)
4 day preharvest interval.
Do not graze or use treated plants or gin trash
for feed or forage. Do not apply to cotton that
is to be harvested by hand or by spindle-type
pickers. Do not apply more than 6 pounds active
ingredient per acre to avoid excessive residues
on raw cottonseed.
General Information: Use as a primary treatment
only for cotton that is to be stripped mechanical-
ly. May be applied to kill new leaf growth prior
to picking after application of a defoliant. Do
not tank mix with other defoliants.
(15.7 Ib/gal SC/L)
004581-00231
or
1-1.5 qt product/A
(75% SC/L)
007401-00184
Preharvest desiccant. Broadcast. Apply uniformly
in 4 to 10 gallons of finished spray per acre.
Do not apply until cotton is mature and all bolls
expected to produce lint are fully opened.
TERRESTRIAL NONFOOD CROP
(Agricultural Crops)
Okra (grown for seed
production only)
[SLN]
6
(15.7 Ib/gal SC/L)
N.F.
Do not graze or use seed for food, feed, or proc-
essing.
SLN - Use limited to AZ .
Preharvest. Broadcast. Apply, in 4 to 10 gallons
of finished spray, 10 to 14 days before harvest.
Issued: 5-27-?
1-006801-3
-------
EPA Compendium of Acceptable Uses
ARSENIC ACID
Listing of Registered Pesticide Products by Formulation
0015 757, soluble concent rate /liquid
arsenic acid (006801)
003008-00043* 007401-00184 007401-00195 007401-00200
*registrant has requested voluntary cancellation.
0015 75% (15.7 Ib/gal) soluble concentrate/liquid
arsenic acid (006801)
000400-00230** 004581-00231 019713-00103# 020004-00003**
**suspended
//scheduled to be suspended
(004581-00231) AZ790038
Issued: 5-27-86 1-006801-4
91
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IV. BIBLIOGRAPHY APPENDICES
92
-------
BIBGUIDE-1
GUIDE TO USE OP THIS BIBLIOGRAPHY
1. CONTENT OP BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
\n the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
2. UNITS OP ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OP ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
93
-------
BIBGUIDE-2
a. Author. Whenever the Agency could confidently Identify
one, the Agency has chosen to show a personal author.
When no Individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author -
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission,
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the"EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number Is In turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 2?th, 123456-AA.
94
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Arsenic Acid Standard
MRID CITATION
00106855 Goldenthal, E.; Wazeter, F=; Dean, W. (1973) Dietary Toxicity
(LC50) Study in Mallard Ducks: Arsenic Acid~75%: 316-004.
(Unpublished study received Jun 28, 1974 under 4581-231; pre-
pared by International Research and Development Corp., submitted
by Agchem Div., Pennwalt Corp., Philadelphia, PA; CDL:026041-B)
00119999 McCann, J.; Pitcher, F. (1973) Delta Brand Arsenic Acid: Bluegill,
Lepomis macrochirus: Test No. 539. (Unpublished study received
Apr 4, 1973 under 295-6; prepared by Pesticides Regulation Div.,
Animal Biology Laboratory, submitted by U.S. Environmental Pro-
tection Agency, Beltsville, MD; CDL:128268-A)
00121618 Goldenthal, E.; Wazeter, F.; Dean, W. (1974) Dietary Toxicity
(LC-50) Study in Bobwhite Quail: 316-004. (Unpublished study
received Apr 9, 1974 under 7401-184; prepared by International
Research and Development Corp., submitted by Voluntary Purchas-
ing Group, Inc., Bonham, TX; CDL:128273-A)
00159870 Jacobson-Kram, D.; Mushak, P.; Piscator, M.; et al. (1984) Health
Assessment Document for Inorganic Arsenic: Final Report: EPA-
600/8-83-021F. Washington, DC: Environmental Protection Agency.
347 p.
GS0389-002 U.S. Environmental Protection Agency (1980) 96-hr LC50 of Arsenic
Acid in Rainbow Trout: Static Jar Test #2446. Unpublished
report prepared by Chemical and Biological Investigations
Branch. 1 p.
GS0389-003 U.S. Environmental Protection Agency (1980) 48-hr EC50 of Arsenic
Acid in Daphnia magna: Static Jar Test #2448. Unpublished
report prepared by Chemical and Biological Investigations
Branch, i p.
-95
-------
V. FORMS APPENDICES
96
-------
HF-KA StCi iuN 3«CH2HB"r SUMMARY SHEET
EPA REGISTRATION NO.
jUCT NAME
i ICANTS NAME
DATE GUIDANCE DOCUMENT ISSUED
th respect to the requirement to submit "generic" data imposed by the FIFRA section 3(C)(2)(B) notice contained in the referenced
jidance Document, I am responding in the following manner:
1. I will submit data in a timely manner to satisfy the following requirements. If the test procedures I will use deviate from (or are not
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group, OECD
Chemicals Testing Programme, I enclose the protocols that I will use:
D2. I have entered into an agreement with one or more other registrants under FIFRA section 3(C)(2)(B)(ii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
AME Or OTHER REGISTRANT
[j3. I enclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data" with
respect to the following data requirements:
D 4. I request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
D 5. I request voluntary cancellation of the registration of this product (This option is not available to applicants for new products.)
'GISTRANT'S AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
'A Form 85EO-1 (10-82)
-------
OMB Approval No. 2000-0468
,qualify, certify ALL four items)
CEHTirJCATiCN OF ATTE.VPTTO C\T-S
INTO AN AGREEMENTW1TH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
I am duly authorized to represent the following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
NAME OF FIRM
EPA COMPANY NUMBER
iis firm or group of firms is referred to below as "my firm".)
My firm is willing to developranoLsubmit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
fy firm has offered in writing to enter into such an agreement Copies of the offers are attached. That offer was irrevocable and included an offer to be
ioiind by an arbitration decision under FIFRA Section-3(c)(2)(B)(iii) if final agreement on all terms could not be reached otherwise. This offer was made
o the following firm(s) on the following date(s): —
NAME OF FIRM
DATE OF OFFER
ever, none of those firm(s) accepted my offer.
y firm requests that EPA not suspend the registration(s) of my firm's product(s), if any of the firms named in paragraph (3) above
ve agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
5 whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statement
>es not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
DNAME
SIGNATURE
DATE
-------
EPA Reg. No.
Guidance Document for
PRODUCT SPECIFIC DATA REPORT
Date
Registration
Guideline No.
§158.120
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-B
63-9
63-10
63-11
63-12
Name of Test
-=-.* -^
Identity of
ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-
density, or
specific gravity
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
PH
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
,-
-------
Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
§158.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
Stability
Oxidizing/ reducing
reaction
h Flammability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral
toxicity, rat
Acute dermal
toxicity, rabbit
Acute inhalation,
toxicity, rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
-------
PORMULATOR'S EXEMPTION STATEMENT
(40 CFR 152.85)
EPA File Symbol/Reg. No. Product Name
Applicant's Name-and Address
As an authorized representative of the applicant for registration of the
product identified above, I hereby certify that:
(1) This product contains the active ingredient(s): --• -
(2) Each active ingredient listed in paragraph (1) is present solely
as the result of the incorporation into the product (during formulation or
packaging) of another product which contains that active ingredient, which
is registered under FIFRA sec. 3, and which is purchased by us from another
producer.
(3) Indicate by circling (A) or (B) below which paragraph applies:
(A) An accurate Confidential Statement of Formula (EPA Form 8570-4) for
the above identified product is attached to this statement. That formula
statement indicates, by company name, registration number and product
name, the source of the active ingredient(s) listed in paragraph (1).
OR
(B) The Confidential Statement of Formula dated on file with
the EPA is complete, current and accurate and contains the information
required on the current CSF Fonr. Mo. S570-4. The registered source(s)
of the active ingredient(s) listed in paragraph (1) is/are listed below:
Active ingredient Source; Product name and Reg. No.
Signature
Date Title
EPA Form (April 1985)
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