PUBLIC
REVIEW
028320 A
CASE NUMBER 42
GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
AS THE ACTIVE INGREDIENT
ACEPHATE
(103301)
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
September, 1985
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TABLE OF CONTENTS
Introduction 1
I. Regulatory Position and Rationale 4
II. Requirement for Submission of Generic Data 70
III. Requirement for Submission of Product-Specific
Data 73
IV. Submission of Revised Labeling 73
A. Label Contents 74
B. Collateral Information 79
V. Instructions for Submission 80
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APPENDICES
Page
II-l Guide to Bibliography 83
II-2 Bibliography 85
II-3 FIFRA §3(c)(2)(B) Summary Sheet - EPA Form 8580-1
II-4 Certification of Attempt to Enter Into an Agreement
with Other Registrants for Development of Data
EPA Form 8580-2
III-l Product Specific Data Report (End-Use Products)
IV-1 40 CFR 162.10 Labeling Requirements
IV-2 Table of Labeling Requirements
IV-3 Physical/Chemical Hazards Labeling Statement
IV-4 Storage and Disposal Instructions
IV-5 EPA Index to Pesticide Chemicals - ACEPHATE
ii
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INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide Act
(FIPRA sec. 3(g)) directs EPA to reregister all pesticides as
expeditiously as possible.
To carry out this task, EPA has established the Regis-
tration Standards program, which will review all pesticide
products containing active ingredients first registered before
January 1, 1977. Pesticides will be reviewed in use clusters
which have been ranked to give earliest review to pesticides
used on food and feed crops.
The Registration Standards program involves a thorough
review of the scientific data base underlying pesticide
registrations and an identification of essential but missing
studies which may not have been required when the product
was initially registered or studies that are now considered
insufficient. EPA's reassessment results in the development
of a regulatory position, contained in a Registration Standard,
on each pesticide and its uses. The Agency may require the
registrant to modify product labels to provide additional
precautionary statements, restrict the use of the pesticide
to certified applicators, provide reentry intervals, modify
uses or formulation types, specify certain packaging limitations,
or other requirements to assure that proper use of the pesticide
will not result in adverse effects on the environment.
The scientific review, which is not contained in this
Guidance Package but is available upon request, concentrates
on the technical grade of the active ingredient and identifies
missing generic data. However, during the review of these
data we are also looking for potential hazards that may be
associated with the end use (formulated) products that contain
the active ingredient. If we have serious concerns, we will
address end use products as part of the Registration Standards
program and will propose regulatory actions to the extent neces-
sary to protect the public.
EPA has the authority under FIFRA sec. 3(c)(2)(B) to
require registrants to submit data that will answer our
questions regarding the hazard that may result from the
intended use of a pesticide. Although sec. 3(c)(2)(B) provides
that all registrants are responsible for these data, the
Agency generally imposes generic data requirements only on the
registrants of the manufacturing use products (basic suppliers
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of the active ingredient) and other producers who do not
qualify for the forraulator's exemption.*
A producer who wishes to qualify for the formulator's
exemption may change his source of supply to a registered
source, provided the source does not share ownership in
common with the registrant's firm. A registrant may do so
by submitting a new Confidential Statement of Formula, EPA
Form 8570-4, identifying the registered source of the active
ingredient, to the appropriate Product Manager within 90
days of receipt of this Guidance Document. The chart on the
following page shows what is generally required of those who
do and do not qualify for the formulator's exemption in the
Registration Standards program.
If you decide to request the Agency to cancel the regis-
tration of any of your products subject to the requirements
of this Guidance Document, please notify the Product Manager
named in the cover letter, within 90 days from the receipt
of this document. If you decide to'maintain your product
registration(s), you must provide the information described in
the following pages within the timeframes outlined. EPA will
issue a notice of intent to cancel or suspend the registration
of any currently registered product which does not comply
with the requirements set forth in this Guidance Document.
You are reminded that FIFRA sec. 6(a)(2) requires you to
submit factual information raising concerns of possible
unreasonable adverse effects of a pesticide. You should
notify the Agency of interim results of studies in progress
if those results show possible adverse effects.
*The formulator1s exemption applies to a registrant of an
product if the source of his active ingredient(s): (1) is a
registered product and (2) is purchased from a source which
does not have ownership in common with the registrant's
firm.
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PRODUCTS SUBJECT TO THE
REGISTRATION STANDARDS PROGRAM
ACTION(S) REQUIRED TO
MAINTAIN REGISTRATION
I. Products That Do Not Qualify
For The Formulator's Exemption
A. Single Active Ingredient
Products*
These products must be reregis-
tered. To obtain reregistration,
labeling, packaging and data
requirements must be satisfied
in accordance with the Regis-
tration Standards Guidance
Document.
B. Multiple Active Ingredient
Products
These products will not be
reregistered at this time.
However, generic data required
to continue the registration of
the active ingredient under
review, as described in the
Registration Standards Guidance
Document, will be required and
some labeling precautions may
also be required.
II. Products That Do Qualify For
The Formulator's Exemption
Only when additional restric-
tions or labeling are needed to
protect man or the environment
will these products be subject
to the Registration Standard
requirements. Affected products
will be dealt with in a variety
of ways, including but not
limited to the Label Improvement
Program and special intent
to cancel notices.
* End use products of registrants who also produce a manufacturing
use product will not be required to be reregistered provided that
registrant fulfills the requirements specified in the Guidance
Document for manufacturing use product(s). Such end use products
will be subject to the labeling changes required for products in "II"
above. If there are no manufacturing use products registered by any
company end use products will be required to be reregistered.
NOTE: If all registrants in "I" above fail to meet the requirements in
I-A and B above, then the registrants in "II" lose their right to
qualify for the formulator's exemption and become subject to the
requirements in I-A and B.
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I. REGULATORY POSITION AND RATIONALE
A. Introduction
This chapter contains the Agency's regulatory position and rationale
on products containing the pesticide acephate as a sole active Ingredient.
The Agency bases its position and rationale on a consideration of all
uses of acephate appearing on pesticide products registered under
Sections 3 and 24 (c) of the PIPRA. There are no acephate products
authorized for distribution in intrastate commerce under 40 CPR 162.17.
The Agency has reviewed the known chemical, environmental, and toxico-
logical characteristics of this pesticide and its established tolerances
£or residues in or on food and feed commodities. Prom these considerations
the Agency sets forth the data and labeling requirements that must be
met by registrants and applicants for registration of Acephate manu-
facturing-use (MP) products in order for their products to be registered
or reregistered under this Standard. Unique labeling requirements and
certain data needs for end-use products (EPs) containing acephate are
also established by this Standard.
Only those data and labeling requirements for current and future
substantially similar MPs and EPs are addressed here. Applications to
register products that differ appreciably from those described in this
Standard may be subject to additional data and/ or labeling requirements.
No new uses of acephate will be considered until the human safety concerns
raised in this Standard are satisfactorily resolved.
B. Description of Chemical
Acephate is the American National Standards Institute (ANSI) approved
cannon name given to the chemical, 0,S-dimethyl acetylphosphoramidothioate.
Other names include Orthene; Ortho 12,420; RE 12,420; and Ortran.
Identifying characteristics and codes are as follows:
Empirical Formula:
Molecular Weight: 183.16
CAS Registry No.: 30560-19-1
ENT Registry No.: 27,822
Shaughnessy No.: 103301
Technical acephate is an off-white crystalline solid. It has
a strong pungent mercap tan- type odor. Its solubility is high in
water, good in polar organic solvents and poor in aromatic solvents.
It is stable at 21 °C but decomposes at its melting point (82-89 °C).
Chevron Chemical Company is the sole producer of acephate in the
United States and markets its products under the trade name, Orthene.
There is one technical/MP (9755) registered and two formulation
intermediate MPs (85% and 75%) registered. There are 28 products
registered for use in the United States under Sect. 3 of the PIPRA.
These include 23 single active ingredient formulations and 5 multiple
active ingredient formulations. On record as of March 13, 1985, there
were 113 products containing acephate registered under Sect. 24(c) of
the FIFRA.
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Acephate is a systemic, organophosphate Insecticide registered
for use on a variety of ornamentals (by both homeowner and conmercial
applicator), agricultural crops, forests, pasture and rangeland, lawns
and turf, indoor use in both conmercial (including food handling
establishments) and residential buildings; and in greenhouses. It is
formulated into soluble concentrate solids, soluble concentrate liquids,
granulars, pressurized liquids, and an 85% cartridge. Acephate is not
a restricted use chemical and is registered for homeowner use as well
as commercial and agricultural uses. Methods of application include
aerial, ground, injection into tree trunks (cartridge formulation);
dip treatment for ornamentals [24(c) registration]; soil incorporated
granular (ornamentals), and sprinklers.
As an organophosphate, acephate exerts its toxic action by inhibiting
certain important enzymes of the nervous system (cholinesterase).
C. Regulatory Position and Rationale
Based on a review and evaluation of all available data and other
relevant information on acephate, the Agency has determined the following:
1. Residue reduction studies and exposure studies are required to
enable the Agency to accurately assess the potential human risks
from current uses of acephate. These data include:
a. Residue studies to determine the fate of residues of
acephate and methamidophos in succulent beans (during
cooking and canning); dried beans (during cooking and
canning; soybean oil (during the refining process); and
soybeans (during processing to defatted flour).
b. A dairy cattle feeding study to determine the fate of
residues of acephate and methamidophos during pasteurization
or processing into the milk fractions; nonfat milk solids,
milkfat solids, and milk sugar (lactose).
c. Applicator exposure studies for forestry application; for
application to both home and commercial ornamentals; and
for indoor application in homes, greenhouses, and commercial
establishments.
d. Postapplication studies of indoor exposure to inhabitants
resulting from application in homes, greenhouses, and
commercial establishments.
e. Usage data (as specified on last page of Table A) and use-
related exposure data (as specified in Table C) for all sites
listed in (c) above in addition to cotton and lettuce.
f. Dermal penetration data.
g. Spray drift data for terrestrial food and nonfood sites,
and for forestry uses.
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h. Glove permeability study for all liquid formulations con-
taining acephate.
1. Reentry data (dislodgeable residue decline curve data for
use on cauliflower and soil residue dissipation data for
use on peanuts).
The use of protective clothing including impermeable gloves,
long sleeved shirt and long legged trousers, is being imposed for
mixer/loaders and applicators as an interim measure to reduce exposure
to users of acephate products pending submittal and evaluation of the
exposure studies described above. Products registered for indoor,
domestic use will be required to bear a label statement prohibiting
children and pets on treated surfaces until spray has dried. Refer
to section P, Required Labeling.
Rationale:
The review has identified a potential chronic effects concern.
Based on the available evidence, i.e., findings from the mouse onco-
genicity study and the mutagenicity assays, the Agency has classified
the chemical as a category C carcinogen (a possible human carcinogen) and,
as such is being regulated by the Agency as a carcinogen. The
available assays indicate that acephate showed consistently positive
responses in gene mutation assays, was active in about 50% DNA repair
assays, was very active in one sister chrcmatid exchange (SCE) in Chinese
hamster cell cultures and was without response in in vivo assays.
The mouse oncogenicity study showed a statistically significant Increase
in the proportion of liver adenomas/carcinomas and hyperplastic nodules
occurring only in the high dose (1000 ppm) females and only at the
time of terminal sacrifice. The proposed EPA guidelines for carcinogenic
risk assessment (PR November 23, 1984) were followed for the evaluation
and classification of the oncogenic effect of acephate. Following
the guidance set forth in the EPA proposed guidelines, the mouse
oncogenic response was considered as "limited evidence." At this
time the Agency is considering the impact of this concern in terms of
potential human risk. To estimate this level of concern, the Agency
is requiring the exposure data and residue studies as specified above.
The Agency believes that, with the use of the protective clothing,
as noted above and the required labeling specified within this standard,
there will be no unreasonable adverse effects in the interim until
exposure assessment data are received and reviewed. Based on conside-
ration of the following points, the Agency believes that the weight
of evidence that acephate is a human carcinogen is weak.
The cancer guidelines state that sufficient evidence of carcino-
geniclty may be shown by an increased incidence of malignant tumors or
combined malignant and benign tumors in multiple species or strains.
The guidelines take the position that the mouse-liver tumor response
could be considered as limited evidence of carcinogenicity when a
number of factors such as the following are observed: The occurrence
of tumors only in the highest dose group and/or only at the end of
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the study; no substantial dose-related increase in the proportion of
tumors that are malignant; the occurrence of tumors that are predomin-
ately benign; no dose-related shortening of the time to the appearance
of tumors; negative or inconclusive results from a spectrum of short-
term tests for mutagenic activity; and the occurrence of excess tumors
only in a single sex.
0 In the case of acephate, the Agency considers the evidence of
carcinogenicity for acephate as limited evidence. In the
following paragraphs, each of these factors is discussed as it
relates to the available information on acephate.
(a) The occurrence of tumors only in the high.est dose group and/
or only at the end of the study.
The statistically significant increase in the liver
adenomas/ carcinomas and hyperplastic nodules were observed
in only the high dose (1000.0 ppm) females and only at
the end of the study. At 52 weeks there was an interim
sacrifice of 40 females. No tumors were diagnosed at
this time. There is no evidence of life shortening due
to hepatocellular carcinomas. The study was not designed to
provide definitive information regarding the time at which
tumors first occurred. Thus, it is not possible to draw any
definitive conclusions regarding the timing of occurrence of
the tumors. However, the incidence of tumors only in the high
dose females tends to support a classification of the
acephate data as "limited evidence" of carcinogenicity.
(b) No substantial dose-related increase in the proportion of
tumors that are malignant.
Though the tumors were predominantly malignant in the high
dose females, the effect was observed only at the highest
dose. Therefore, there is no observed dose-response
relationship for the malignant tumors (carcinomas).
However, the power of this and any other similar study does
not usually allow a definitive conclusion on the absence of
dose response.
(c) The occurrence of tumors that are predominantly benign,
showing no evidence of metastasis or invasion.
The ratio of percentage of carcinomas to adenomas in the
high dose females is 15.8? to 3.9%. This supports a
conclusion that malignant tumors are the predominant
tumors. Therefore, this information is supportive of a
classification of "sufficient" for acephate.
(d) No dose-related shortening of the time to the appearance
of tumors.
There was an interim sacrifice at 52 weeks of 40 females.
No tumors were observed at this time. Tumors were observed
only at the end of the study in high dose females. Thus,
within the limitations of the study design, there does not
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appear to be evidence of a shortened time to tumor effect.
However, as indicated above, the study was not designed to
provide definitive information regarding the time at which
tumors first occurred.
Recognizing these limitations, the Agency believes that the
evidence is adequate to conclude that there probably was
not a shortening of the time to the appearance of tumors.
Therefore, this factor tends to support a classification
of the acephate data as "limited evidence" of carcinogencity.
(e) Negative or inconclusive results from a spectrum of short-
term tests for mutagenic activity.
Acephate induces gene mutations, DNA repair and sister
chromatid exchanges. It was positive or weakly positive
in eight gene mutation assays with activation, and negative
in two acceptable studies. It was positive in one acceptable
change DNA repair assay with activation, and negative in
two acceptable studies. It was positive in one acceptable
sister chroraatid exchange assay with activation. It has
been negative in two acceptable in vivo studies. The
overall conclusion is that acephate has a definitive
effect in a number of mutagenic assays. The in vivo
assays, which were without response are generally regarded
to be of lesser sensitivity, nontheless, these negative
effects show that acephate is not a strong mutagenic
agent under _in vivo conditions, while moderately mutagenic
in cellular systems (prokariots and eukariots). Therefore,
this information is supportive of a classification of
"sufficient" for acephate.
(f) The occurrence of excess tumors only in a single sex.
The tumors occurred only in the female mice. Therefore,
this supports a "limited evidence" of carcinogenicity
classification for acephate.
(g) Other data:
The rat oncogeniclty study showed an increased incidence
of medullary neoplasms in the adrenal gland (pheochromocytomas)
of the acephate-treated male rats when related to the
concurrent controls.
The incidence of pheochromocytomas in the acephate-treated
male rats, however was within the ranges reported for the
historical control male rats of the same strain. Following
extensive analysis, Agency scientists concluded that the
rat study is not indicative of an oncogenic response to
acephate.
Available studies on the metabolism of acephate by rats, dairy
cattle, pigs and goats have shown that acephate is excreted
essentially unchanged in mammalian urine. The excretion is rapid
and there is no accumulation of acephate in tissues.
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Serious consideration was given to the initiation of a Special
Review because of the potential human safety concern identified during
the Standard review process. As noted, the Agency believes the weight of
the evidence that acephate is a human carcinogen is limited. Further, it
has been determined that a Special Review could not now be usefully
conducted because of the gaps in important data, particularly exposure
data, listed in items C. l(a) through (i) above. These data are
necessary to enable the Agency to complete a risk assessment under
the Special Review process and to make a determination regarding the
registration status of acephate. Once these data are received, the
Agency will initiate an expedited review and evaluation of the data.
Therefore, because the Agency believes required measures will prevent
unreasonable adverse effects in the interim until exposure data are
received and reviewed, because the Agency considers that the weight of
evidence that acephate is a human carcinogen is weak, because additional
studies are needed to accurately determine the potential risk to humans
and because the required time and resources do not justify a Special
Review at this time, the Agency is not placing acephate into Special
Review at this time.
In making future decisions on acephate, the Agency will also take
into consideration results of the toxicity studies for acephate's
cholinesterase-inhibiting metabolite, methamidophos* which have been
received and are now under review by the Agency. These studies include
a mouse oncogenicity study, a rat chronic feeding/oncogenicity study,
a dog chronic study, a rat teratology study, a rat reproduction study
and mutagenicity studies. Until these studies are reviewed, particularly
the chronic feeding, oncogenic and mutagenic studies, the possibility
that the high-dose oncogenic effect of acephate may be due to methamidophos
cannot be unequivocally eliminated. A preliminary review of the submitted
oncogenic studies for methamidophos indicate that they are negative, but
further reviews are necessary to confirm this preliminary finding.
Technical acephate contains 0.9 to 1.2% w/w of methamidophos. A
portion of acephate (generally, from 0.6 to 10%) can also be converted
to methamidophos by microorganisms in mammalian gut (and be absorbed)
and by plants.
Available residue data are not sufficient to allow the Agency to
complete its assessment of the potential dietary risk to consumers of
acephate-treated food commodities. Data are needed to determine the
fate of residues of acephate and its metabolite, methamidophos, during
processing of these commodities.
The Registration Standard for methamidophos was issued by the Agency
tember 30. 1982.
September 30, 1982.
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Available data suggest that cooking and canning would be a
potential route of dietary exposure reduction. For example, in two
canned succulent bean samples, residues of acephate and methamidophos,
represented 12-58/5 and 34-65/6 respectively, of the residues determined
In/on the raw agricultural commodity. Although there are limited
cooking and canning data available, the results are inconclusive and,
moreover, the percentage of residues lost during cooking or canning is
expected to depend upon the conmodity in question and, therefore,
studies need to be conducted on each crop individually.
Thus, the residue studies on food prepared for consumption for the
specified commodities as cited in C,l(a) and (b) above are needed to
accurately assess the dietary risk from use of acephate as described
in this document. Until the required studies are received and the
Agency has completed its evaluation of the dietary risks posed by the
current established tolerances, no additional tolerances for acephate
will be considered.
Because dermal penetration data are lacking for acephate, the Agency
is unable to determine the amount of dermal absorption of the material
resulting from various levels of exposure. The Agency is requiring that
such data be submitted.
The exposure studies and usage data cited in C.I (c), (e), and (f)
above are needed to enable the Agency to accurately assess the potential
risk to applicators from the use of acephate as described in this document.
As an interim precautionary measure to reduce the potential exposure
to applicators, use of protective clothing including impermeable gloves,
long-sleeved shirt and long legged trousers is being Imposed. However,
tests defining glove permeability of liquid formulations are required
so that a determination can be made as to what specific glove materials
are resistant to acephate formulations (including the inert Ingredients)
and to also determine the breakthrough times.
Additionally, the studies of indoor exposure to inhabitants are
required to accurately assess the postapplication risk to nonapplicators.
The current registered methods of application of acephate in indoor
domestic settings are limited to localized areas. These application
methods are crack and crevice, spot spray and paint brush spot treatments
for use by pest control operators or service persons; and foliar treatment
of house plants by homeowners. Because these uses of acephate in Indoor
residential settings are considered a limited use pattern in that
application is limited to selective specified surfaces and does not
include general treatment (application to broad expanses of surfaces such
as walls, floors), it is expected that the potential exposure to
inhabitants would be minimal. The current registered acephate product
labels registered for indoor, domestic use carry the following restriction:
Do not allow children or pets on treated surfaces until spray has
dried. This restriction will continue to appear on all such acephate
products to reduce exposure until a fuller assessment of risks can be
made.
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Spray drift data are also required to determine the potential
exposure to humans who may be present in the area at time of application.
Pending submlttal and evaluation of the studies necessary to
evaluate the potential risk to humans from the present uses of acephate
as described in this document, the Agency will not consider any new
uses of acephate that would result in an increase in the current
exposure or in new exposure, i.e., exposure to segments of population
not previously exposed.
2. An interim reentry interval of 24 hours is being imposed for
fieldworkers. Reentry prior to lapse of the 24 hour interval
requires the use of protective clothing Including impermeable
gloves, longsleeved shirt and long legged trousers. Greenhouse
workers who may be exposed to treated plant surfaces in greenhouses
within 24 hours after application must wear protective clothing,
including impermeable gloves, long-sleeved shirt and long legged
trousers.
Rationale:
The available worker exposure data show that dislodgeable acephate
residues decline rapidly from leaf surfaces with approximately half of
the applied acephate dissipated within 24 hours following application.
Additional data, however, are needed for the Agency to accurately
determine the potential exposure risk to field workers. These data
include the dermal penetration and the reentry data described in the
preceding section C.I of this document. As an interim precautionary
measure, the Agency is imposing the 24-hour reentry interval for
field workers.
Although the scope of the current reentry guidelines (subdivision K),
is limited to use patterns associated with growing crops and does not
include interior settings, it is expected that greenhouse workers
could encounter substantial dermal exposure to acephate residues in
treated greenhouses. Therefore, the Agency is imposing the use of
the protective clothing described above by greenhouse workers who may be
exposed to treated plant surfaces within 24 hours after application
of acephate, as an interim measure. As described in section C.I of
this document, data defining glove permeability of liquid formulations
of acephate is being required.
As described in C.I. above, it is expected that the potential
exposure to inhabitants resulting from the use of acephate in homes
would be minimal.
3. To support continued registration of peppermint and spearmint uses,
additional residue data for mint hay supporting a lower tolerance
are required. To support continued registration of range and
pastureland uses, residue data on grass hay supporting a lower
tolerance are required. Pending submittal and evaluation of these
data, use restrictions prohibiting the feeding of spent mint hay and
grass hay to lactating dairy animals are being imposed as an
interim measure. Refer to section F, Required Labeling.
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Rationale:
As a part of the reregistration process, the established tolerance
levels for acephate in meat, milk, poultry, and eggs have been reeval-
uated.
In determining the level of secondary residue likely to occur in
meat, milk, poultry or eggs from ingestion of treated feed items, the
proportion in the animals diet of the feed items bearing the residue
must be taken into account,' along with the tolerance level established
for those feed items. Table II of the Residue Chemistry guidelines
(Subdivision 0) is used as a guide in determining the proportion of
the diet of the various feed items. In the case of acephate, the
amount of residues contributing to the animals diet from ingestion of
acephate treated feed items, particularly spent mint hay or grass hay
is larger than was previously thought.
The available swine and cattle feeding studies indicate that the
tolerances for the fat, meat, and meat byproducts of swine, cattle,
goats, horses and sheep are adequate. Also, the available poultry
feeding data indicate that the tolerance levels in eggs and poultry
fat, meat, and meat byproducts are adequate.
However, the available residue data indicate that the established
tolerance level for acephate residues in milk is likely to be exceeded
if maximum levels of spent mint hay or grass hay are included in the
dairy animal diet.
Thus, the additional mint hay and grass hay data as cited above
are needed to reduce the current tolerances in/on spent mint hay and
grass hay. The label restrictions cited above are needed as an
interim precautionary measure to ensure that the tolerance level for
acephate residues in milk is not exceeded.
4. The following revisions in 40 CPR 180.108, 21 CPR 561.20, 40 CFR
180.315, 21 CFR 561.277 and 21 CPR 193-10 are to be initiated by
the Agency.
- 40 CFR 180.108 and 21 CFR 561.20
The acephate tolerances currently established under these
sections are to be expressed in terms of only acephate
per se, with references to sections 40 CFR 180.315 and
21 CFR 561.277 indicating that tolerances for the metabolite,
methamidophos are also in effect.
- 40 CFR 180.315 and 21 CFR 561.277
The methamidophos tolerances currently established under
these sections are to be divided into parts (a) and (b)
where (a) includes (1)tolerances reflecting use of
methamidophos and (2) tolerances where both acephate and
methamidophos formulations are used on the same crops, and
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(b) includes tolerances reflecting use of acephate
formulations alone, i.e., residues of roethamidophos resulting
fron the metabolisn of acephate.
- 21 CFR 193.10
These food additive tolerances reflecting crack and crevice
treatment in food-handling facilities are to be expressed
in terms of only acephate per se, i.e., based on available
data, no residues of the metabolite methamidophos are
expected to occur «0.001 ppm) in or on these foods.
Also, such a change in the residue definition would require
deletion of the paragraph (d)(8) of 40 CFR 180.3 which states that
methemidophos residues may not exceed the higher of the two tolerances
established for the use of acephate or methamidophos as a pesticide.
Refer to Table 2 at the end of this chapter for the tolerance
changes reflecting this change in the residue definition.
Rationale:
The change in residue definition, i.e., to change the expression
for acephate tolerances from combined residues of acephate and
methamidophos to residues of acephate per se, would achieve compati-
bility with the maximum residue levels (MRLs) of the Codex Alimentarius
Commission at least in terms of residue definition. This change
would also result in the U.S. tolerances and the Codex MRLs for acephate
being compatible for the following commodities: cottonseed, eggs,
animal tissues, lettuce, and milk. Residue data preclude decreasing
the soybean acephate tolerance of 1 ppm to the Codex MRL level of 0.5
ppm. Of the methamidophos tolerances altered or created due to the
recommended change in residue definition, only those for residues in
animal tissues are compatible with Codex MRLs. Based on the residue
data, the tolerances recommended for methamidophos in or on cottonseed,
milk, and soybeans cannot be reduced to the levels of the corresponding
Codex MRLs. Although the recommended change in residue definition
would result in "new" tolerances for methamidophos, these tolerances
merely reflect the residue levels that are already present in/on the
specified crops resulting from the metabolism of acephate.
5. The Agency is requesting additional ground water data on an
accelerated basis in order to evaluate the potential for ground
water contamination. These studies include mobility,
photodegradation, metabolism and dissipation data.
Rationale:
Due to its rapid leaching behavior, acephate has the potential
for groundwater contanination. Available studies are insufficient to
assess this potential. Thus, additional data are required.
13
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Available studies show that acephate dissipates rapidly with half-
lives of <3 and~6 days in aerobic and anaerobic soils, respectively.
The major metabolite was C02 in both types of soil. Apparently most of
the applied acephate and the degradate methamidophos degrade to immobile
compounds in^^-20 days.
6. The Agency is requiring an avian residue monitoring study.
The need for additional testing will depend on results of this
monitoring study.
Rationale:
Although the dietary toxicity of acephate to avian species is
not considered high, its metabolite, methamidophos, has been shown
to be very toxic to birds in dietary exposures. Available data on
methamidophos residues occurring in avian feed items fron appli-
cation of acephate at 1 Ib active ingredient per acre, suggest
that residue levels of methamidophos may occur as high as 9% to
41% of the bobwhite acute dietary toxicity value. This is of
regulatory concern as published EPA regulations [162.11(c) (2)(iii)(B)]
state that a pesticide would be a candidate for restricted use if
dietary residues exceed 1/5 (i.e., 20%) of the avian acute toxicity
value immediately after treatment. The avian residue monitoring data
are required to support continued registration of the multiple
application, high use rate field crops.
7. The Agency is imposing interim labeling to protect endangered
species.
Rationale:
Appropriate labeling for the protection of endangered species
determined to be in jeopardy has been developed by the Agency using
a generic (cluster) approach.
This generic approach, which entails the analysis of the effects
of all pesticides on endangered species on a crop-by-crop basis, rather
than a chemical-by-chemical approach, is being developed in cooperation
with Federal and State enforcement agencies, the Office of Endangered
Species (OES) and the U.S. Department of Agriculture (USDA), using the
extension services and the National Agricultural Chemical Association
(NACA). Thus, the labeling developed under this approach will encompass
all endangered species associated with use of pesticides on a particular
crop.
Individual chemical reviews, such as this registration standard
for acephate will, drawing on information developed in the clusters,
consider all product uses and associated endangered species and impose
appropriate label restrictions on a case-by-case basis. The label
statements, identified in Section F/ including the state-by-state
listing of endangered species, must be added to the acephate label for
the 1986 growing season. Additional labeling may be required if: new
uses are added to the label or, as the Agency continues investigations
14
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on these issues, if additional endangered species information develops
indicating a potential for hazardous exposure.
The Agency is imposing labeling restrictions for the protection of
the following endangered species determined to be in jeopardy from use
of acephate: masked Bobwhite, Aleutian Canada Goose, California Condor,
Hawaiian Goose, Kirtland's warbler, Mississippi Sandhill Crane,
Attwater's Greater Prairie Chicken, and the Whooping Crane. Reter
to F.3.g. of this chapter for the labeling restrictions required to
appear on acephate products labeled for use on soybeans, alfalfa,
peanuts, beans, forest, pasture and rangeland.
8. The Agency is requiring a rat reproduction study utilizing a lower
dosage level than that used in the current rat reproduction study.
Rationale:
Though the current study is considered a scientifically valid study,
it does not fulfill the data requirement for a reproduction study in
that a no-observable effect level (NOEL) was not determined.
Various reproductive effects (low pregnancy rate, high loss of total
litters, high fetal losses, decreased size and weight of total litters
and decreased number of live fetuses) were observed at the lowest dose
level tested which was 50.0 ppm of technical acephate (93% acephate).
When a 100 fold safety factor is applied to this level, it is equiva-
lent to the current acceptable daily intake (ADI) level for acephate.
The occurrence of these effects raises a question of concern over the
potential risk to humans, resulting from exposure to acephate. There-
fore, a rat reproduction study utilizing a lower dosage level than
that used in the current study is required in order to determine a
definite NOEL for reproductive effects, and to enable the Agency to
evaluate the potential risk of such effects on humans from exposure
to acephate. However, it should be noted the effects were seen only
at levels which are substantially higher than that to which humans can
reasonably be anticipated to be exposed, taking into account ample
margins of safety. Therefore this data does not trigger a special
review.
Should the new rat reproduction study show a lower effect level,
the current ADI for acephate may be changed accordingly.
9. In suttmary, the results of the available toxicological studies
on acephate are listed below.
Acute oral - rat: 945 mg/kg (male); and 866 mg/kg (female)
Toxicity Category ill
Acute dermal - rabbit: >10,000 mg/kg (male)
Toxicity Category III
Acute inhalation - rat: >61.7 mg/kg (male and female)
Toxicity Category IV
Mouse oncogenicity: Female mice, fed 1000 ppm of technical acephate
(highest dose tested), had a statistically significant higher
15
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Incidence of hepatocellular carcinomas (15.8/&) and hyperplastic
nodules (19.7/&) than did the controls.
Rat oncogeniclty: Not oncogenlc to male and female rats under the
conditions of the study; highest dose tested was 700 ppm
(35 mg/kg).
Rat chronic feeding: NOEL = 5 ppm (0.25 rag/kg), based on the
inhibition of chollnesterase activity in plasma, RBC and brain.
Dog chronic feeding: NOEL = 30 ppm (0.75 mg/kg) based on the
inhibition of plasma, RGB and brain cholinesterase activity.
NOEL = >100 ppm (2.5 mg/kg) for systemic toxicity.
Rabbit teratogenicity: Not fetotoxic or teratogenic at 10 mg/kg
(highest dose tested).
Rat teratogenicity: Not teratogenic at 200 mg/kg (highest dose
tested).
Mutagenicity: The available studies indicate that acephate can
induce gene mutations, DNA repair, and sister chromatid
exchanges. However, in vivo studies indicate that these
effects, and structural chromosome aberrations, are not
produced at a detectable level in an intact mammalian system.
10. Additional toxicologies! testing are required to be conducted on
methylthioacetate (MTA) which occurs as an impurity in the current
registered technical material.
Rationale:
Results of an acute dermal toxicity study with MTA on rabbits
indicate nonreversible diminution or absence of pupillary light reflex
and blindness caused by gliosis, macrophage accumulation, malacia, and
papilledema of the optic nerve, optic tract, and brain between the
optic chiasm and the pituitary. The dose levels tested were 1500,
2000, 2500 and 3000 mg/kg (dermal dose applied to a gauze sponge).
The clinical signs reported with an interim report of a second dermal
study in rabbits showed no indication of blindness. None of the other
available studies on MTA showed any clinical sign of blindness.
The available data suggest that MTA, despite its generally low
acute toxicity, may pose a hazard to the optic tract and pituitary
gland in rabbits and other mammals at low doses. Data were not provided
to demonstrate a NOEL for lesions at these target organs. Since visual
impairment is Inherently difficult to diagnose in animals, it is possible
that this effect occurred in other studies but was not detected. In
addition, a mutagenic effect was seen in the mouse lymphoma assay in the
activated system. Due to the insufficiency of the submitted data to
explain the toxic and mutagenic potential of MTA, the Agency requires
that additional studies be performed.
16
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These studies, which are identified in Table A located at the end
of Chapter II, include a 90-day dermal in rabbits, acute oral in rat and
rabbits, acute inhalation, the final report of a second acute dermal in
rabbits, neurophysiological studies of the visual system and mutagenicity
studies.
Results of the available toxicological studies conducted with MTA
are sumnarized below:
Acute dermal - rabbit: 1720-2820 mg/kg: Toxicity Category II-III
Clinical signs included Irreversible absence/diminution of
pupillary light reflex and apparent blindness.
Acute inhalation - rat: 3.47 mg/1: Toxicity Category III
Skin irritation - rabbit: 2.6 Primary Irritation Score: Toxicity
Category III
Skin sensitization - guinea pig: non-sensitizing and nonirritating;
dose level tested was 0.3 ml (0.3g)
Eye irritation - rabbit: Toxicity Category III; dose level tested
was 0.1 ml of 93.5% MTA.
Mutagenicity - mouse lymphoma assay: mutagenic to lymphoma cells
in the activated system, but not in the nonactivated system;
levels tested were 1-10,000 microgram/ml (activated) and
10-5,000 microgram/ml (nonactivated).
D. Criteria For Registration Under The Standard
To be covered under this Standard, products must contain acephate
as the sole active ingredient, bear required labeling, and conform to
the product composition, acute toxicity limits, and use pattern require-
ments listed in section E of this document.
The applicant for registration or reregistration of manufacturing-use
products subject to this Standard must comply with all terms and
conditions described in it, including submission of an up-to-date
Confidential Statement of Formula, submission of revised labeling,
commitment to fill data gaps on the schedule specified by the Agency
and, when applicable, offer to pay compensation as required by 3(c)(l)(D)
and 3(c)(2)(D) of the Federal Insecticide, Fungicide and Rodenticide
Act (FIFRA), as amended, 7 U.S.C. 136(c)(l)(D) and 136(C)(2)(D).
Registration applicants must contact the Agency for specific instructions,
including updated information on data requirements and companies whose
data have been used in support of registration.
Registrants of end-use products who do not qualify for the Forraulator's
Exemption must satisfy labeling, packaging and data requirements in
accordance with this guidance package. Registrants of end-use products
who qualify for the Formulator's Exemption must comply with the unique
labeling statements Identified in Section F.
17
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E. Acceptance Ranges And Limits
1. Product Composition Standard
To be covered under this Standard, manufacturing-use products must
contain acephate 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 which may be present in products.
2. Acute Toxlcity Limits
The Agency will consider registration of technical grade and
manufacturing-use products containing acephate, provided that the
product labeling bears appropriate precautionary statements for the
acute toxicity category in which each product is placed.
3. Use Patterns
To be registered under this Standard, manufacturing-use products
containing acephate must be labeled as limited for formulation
into end-use products only for the uses listed below. The attached
index entry (Appendix IV-5) lists all registered uses, as well as
approved maximum application rates and frequencies.
0 Terrestrial, nondomestic, food uses on: cauliflower, brussels
sprouts, peanuts, peppermint, spearmint, pasture, rangeland,
beans, celery, cotton, head lettuce, peppers, soybeans, cotton.
0 Aquatic, nondomestic, food use on: cranberries.
0 Terrestrial, nondomestic, non-food uses on: tobacco; forests;
grasses and broadleaf weeds in nonbearing pistachio orchards
[24(c) registration]; ornamentals (field grown, and nursery stock);
wasteland; commercial turf.
0 Domestic outdoor use on: lawns; ornamentals; residential turf
areas (parks, recreational areas); and as a perimeter treatment
adjacent to and on the surfaces of buildings.
0 Domestic indoor use on: house plants; and as a spot treatment
in residential, industrial, institutional, and commercial
buildings and in transportation equipment.
0 Nondomestic indoor use: ornamental and forest greenhouse plants
18
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F. Required Labeling
All manufacturing-use and end-use acephate products must bear
appropriate labeling as specified in 40 CFR 162.10. The guidance
package for this Standard contains information on label requirements.
All labeling changes, with the exception of the end-use product labeling
as specified below, must appear on all products released for shipment
by October, 1986. All labeling changes, with the exception of the
end-use product labeling as specified below, must appear on all products
in channels of trade by October, 1987.
In addition to the above, the following information must appear on
the labeling:
1. Ingredient Statement
The ingredient statement for MPs must list the active ingredient
as: Acephate, (0,S-dimethyl acetylphosphoramidothioate)... %
2. Use Pattern Statements
All manufacturing-use acephate product labels must state that
the products may be used for formulation into end-use products
only for the aforementioned use patterns. Labeling must
specify sites, which are listed in Use Patterns, Section E.3.
A limiting factor will be data that support these use patterns.
No use may be included on the label where the registrant
fails to agree to comply with the data requirements in either
Table A or Table B for that use pattern.
3. Precautionary Statements
Statements for Manufacturing-Use Products
a. Labels for manufacturing-use acephate products must
bear statements reflecting the compound's acute human
toxicity. Acephate is in Toxicity Category III by the
oral and dermal routes of exposure and in Category IV
by the inhalation route of exposure; the required
precautionary statements associated with these categories
are specified in 40 CFR 162.10.
b. The following environmental hazard statement must
appear on all MP labels:
"Do not discharge effluent containing this product
directly into lakes, streams, ponds, estuaries,
oceans or public waters unless this product is
specifically identified and addressed in an NPDES
permit. Do not discharge effluent containing this
product to sewer systans without previously notifying
the sewage treatment plant authority. For guidance,
contact your State Water Board or Regional Office of
the Environmental Protection Agency."
19
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c. The following interim protective clothing statement
must appear on all MP labels:
Wear protective clothing including impermeable
gloves, long-sleeved shirt and long legged trousers
when handling this product.
Statements for End-Use Products
The following labeling changes must appear on all
end-use products released for shipment by April, 1986.
The following labeling changes must appear on all products
in channels of trade by October, 1986.
a. The following interim protective clothing statement
must appear on all EP labels.
During all mixing/loading operations and during
application, wear protective clothing including
impermeable gloves, long-sleeved shirt and long
legged trousers.
b. The following restriction must appear on acephate
products labeled for domestic indoor use:
Do not allow children or pets on treated surfaces
until spray has dried.
c. The following interim worker reentry interval statement
must appear an acephate products labeled for use on
field crops.
Do not reenter treated fields within 24 hours
following application. Should reentry prior to
this time be necessary, protective clothing including
impermeable gloves, long-sleeved shirt and long legged
trousers must be worn.
d. The following interim protective clothing statement
must appear on acephate products labeled for greenhouse
use:
Greenhouse workers who may be exposed to treated
plant surfaces within 24 hours following application
of acephate must wear protective clothing including
impermeable gloves, long-sleeved shirt and long
legged trousers.
20
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e. The following environmental hazard statements must
appear on acephate products labeled for the specified
uses.
1. Agricultural and Ornamental Uses
This pesticide is toxic to birds. Do not apply
directly to water or wetlands. Do not contaminate
water by cleaning of equipment or disposal o£
wastes. Cover or soil-incorporate spills.
2. Forest and Rangeland Use
This pesticide is toxic to birds. Applications
may adversely affect birds in treatment areas.
Do not apply directly to water or wetlands except
under forest canopy. Do not contaminate water by
cleaning of equipment or disposal of wastes.
Cover or soil-incorporate spills.
3. Agricultural Crop Uses
This product is highly toxic to bees exposed to
direct treatment or residues on blooning crops or
weeds. Do not apply this product or allow it to
drift to blooming crops or weeds if bees are
visiting the treatment area.
f. Interim use restriction statements (Refer to C.3. of
this chapter)
1. Peppermint and spearmint:
Do not use spent mint hay for feed for dairy
animals.
2. Pasture and rangeland:
Do not graze or feed grass hay to dairy
animals.
g. The following endangered species restrictions, including
the state-by-state listing of endangered species specified
in the following chart, must appear on acephate products
labeled for the uses specified in the chart:
It is a violation of Federal laws to use any pesticide
in a manner that results in the death of an endangered
species or adverse modification of their habitat.
The use of this product may pose a hazard to certain
Federally designated endangered species known to occur
in specific areas within the following counties:
21
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ENDANGERED SPECIES RESTRICTIONS
STATE, SPECIES,
(BULLETIN NO.)
SOYBEANS
PASTURELAND
& RANGELAND
ALFALFA
PEANUTS
FOREST
BEANS (TEna,
dried type
and succulent)
Arizona
Masked Bobwhite
(EPA/ES-85-14)
Arizona (South
of Tucson)
California
(1) Aleutian
Canada Goose
(EPA/ES-85-02)
(2) California
Condor
(EPA/ES-85-15)
Colusa
Merced
Stanislaus
Tulare, Kern
Los Angeles
Ventura
Santa Barbara
Obispo
Colusa
Merced
Stanislaus
Colusa
Merced
Stanislaus
Hawaii
Hawaiian Goose
(EPA/ES-85-16)
Maul, Hawaii
Michigan
Kirtland's
Warbler
(EPA/ES-85-17)
Crawford
Oscoda
losco
Montmorency
Presque Isle
Roscommon
Alcona
Kalkaska
Ogemaw
Otsego
Wexford
22
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ENDANGERED SPECIES RESTRICTIONS (continued)
STATE, SPECIES,
(BULLETIN NO.)
Mississippi
Mississippi
Sandhill Crane
(EPA/ES-85-18)
Texas
Attwater's
Greater Prairie
Chicken
(EPA/ES-85-01)
Whooping Crane
(EPA/ES-85-19)
SOYBEANS
Austin
Colorado
Port Bend
Victoria
Arnasas
Brazoria
Galveston
Refugio
Goliad
PASTURELAND
& RANGELAND
Jackson County
Austin
Colorado
Port Bend
Golaid
Victoria
Arnasas
Brazoria
Galveston
Refugio
Idaho, Utah,
Wyoming,
Colorado,
New Mexico,
N. Dakota,
S. Dakota,
Nebraska,
Kansas, Texas,
Oklahoma
ALFALFA
Austin
Colorado
Port Bend
Golaid
Victoria
Arnasas
Brazoria
Galveston
Refugio
Socorro and
Valencia,
New Mexico
1
PEANUTS
Austin
Colorado
Brazoria
Fort Bend
FOREST
BEANS (lima,
dried type
and succulent)
Before using this product in the above counties you must obtain the EPA Bulletin specific to your area. This Bulletin
identifies areas within these counties where the use of this pesticide is prohibited, unless specified otherwise in
the Bulletin. The EPA Bulletin is available either from your County Agricultural Extension Agent, the Endangered Species
Specialist in your State Wildlife Agency Headquarters or the appropriate Regional Office of the U.S. Pish and Wildlife
Service. THIS BULLETIN MUST BE REVIEWED PRIOR TO PESTICIDE USE.
23
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G. Tolerance Reassessment
The currently established tolerances for combined residues of
acephate and its metabolite methamidophos, as currently established
under 21 CFR 193.10, 21 CFR 561.20, and 40 CFR 180.108, are supported
by the available data in or on the following comiodities or processed
products: beans (dry and succulent), brussels sprouts, cauliflower,
celery, cottonseed, cranberries, lettuce (head), mint hay, pasture and
range grass and hay, peanuts, peanut hulls, peppers, soybeans, cotton-
seed meal and hulls, soybean meal, all foods exposed in food handling
establishments, eggs, and the fat, meat, and meat byproducts of cattle,
goats, hogs, horses, poultry, and sheep. The currently established
tolerance for acephate residues in milk has been found likely to be
exceeded if maximum levels of spent mint hay or grass hay are included
in the dairy animal diet; refer to C.3 of this chapter for the Agency's
position and rationale regarding this problem. Refer to Table I at
the end of this chapter for the current tolerance levels for the U.S.,
Mexico, and Codex.
Additional data are required to assess human exposure to acephate-
treated tobacco (aerial application data). No crop group tolerances
are appropriate at the present time due to lack of sufficient data
within each group.
A change in the residue definition for acephate tolerances is to
be initiated by the Agency. Refer to C.4 of this chapter for details
of this change. Refer also to Table 2 at the end of this chapter for
the tolerance changes reflecting this change in the residue definition.
The metabolism of acephate in plants and animals is adequately
understood. Available data show that the residues in or on plants
resulting from acephate use may be largely or wholly intact acephate
and its metabolite, methamidophos. Available animal metabolism data
show that most of the radiolabeled material is rapidly eliminated from
the body and that a majority of the material was excreted in the urine.
Methamidophos is not the major metabolite in ruminants. About 80 percent
of the radiolabeled material in the urine was associated with unchanged
acephate, and less than 10 percent with the metabolite, O,S-dimethyl
phosphorothioate. Most of the methamidophos formed is probably
eliminated and excreted in the urine as 0,S-dimethyl phosphorothioate.
The available plant metabolism studies show that acephate residues
are readily absorbed by the roots and translocated throughout the plant.
Data show that acephate does not accumulate in carrot plants rotated in
acephate-treated soil or in fish, daphnia, or diatoms.
24
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Acephate's Acceptable Dally Intake (ADI) for non-carcinogenic
effects, is 0.0250 mg/kg/day based on the chronic rat feeding study
with a NOEL of 5.0 ppm (0.25 mg/kg/day) and using a safety factor of
10. This safety factor was used because the rat NOEL level of 5.0 ppm
is based on cholinesterase activity in brain, plasma and red blood
cells. It is the Agency's policy to use a safety factor of 10 in such
cases, since this activity is considered to be the more sensitive criteria.
The maximum permissible intake (MPI) is 1.500 rag/day for a 60 kg human.
The Theoretical Maximum Residue Concentration (TMRC), based on relevant
food factors and established tolerances, is .4592 mg/day/1.5 kg. This
figure represents 30.61 percent of the ADI. As described in C.8. of
this chapter, results of the new rat reproduction study may effect the
current ADI for acephate.
As described in C.I of this chapter, additional residue studies
are required to better define the dietary exposure to residues of acephate
fron treated food items as consumed. Pending submittal and evaluation
of these data, no new tolerances including temporary tolerances, will be
considered for acephate nor its metabolite, methamidophos.*
* A restriction against the establishment of further tolerances for
methamidophos was previously imposed under the Methamidophos Registration
Standard issued September 30, 1982.
25
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Table I. Present Tolerances;
The following tolerances for residues of acephate exist In the United States
and Mexico, and several international maximum residue limits (MRLs) have
been recommended by the Codex Alimentarius Commission (listed below). No
acephate tolerances are in effect in Canada. Note that U.S. tolerances
cover combined residues of acephate and its metabolite methamidophos and
that Mexican tolerances (presumably) and Codex MRLs cover only acephate per se.
Commodity
Tolerances (ppm)
a/ b/
United States Mexico International (Codex)
Alfalfa
Beans (dry and
succulent)
Broccoli
Brussel sprouts
Cabbage
Cattle (fat, meat,
meat byproducts)
Cauliflower
Celery
Chili pepper
Citrus fruits
Corn
Cottonseed
Cottonseed hulls
10
3(1.0)
3(0.5)
0.1
2(0.5)
10(1.0)
3
10
8
10
4
1
4
8(PA)d/
5
5
5
0.1
26
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Conroodity
Cottonseed meal
Cranberries
Eggs
Goats (fat, meat,
meat byproducts
Grapes
Grass
Grass hay
Hogs (fat, meat,
meat byproducts)
Horses (fat, meat,
meat byproducts)
Lettuce
Melons
Milk
Mint hay
Nuts
Peanuts
Peanut hulls
Peppers
Tolerances (ppm) (Continued)
V
United States Mexico International (Codex)
8 _
0.5(0.1) — —
0.1 — 0.1
0.1 — —
— 5 —
15
1 S — — —
0. 1 — 0. 1
OT __
. i
10(1.0) 10 10
. o __
0.1 — 0.1
15(1.0) — —
— 0.2 —
0.2 0. 1
c Iim^m ___
4(1.0)
Potatoes
Poultry (fat, meat,
meat byproducts)
0.1
0.5
0.1
*This table does not include the tolerance for acephate in/on macadamia nuts
(0.5 ppm) which was established subsequent to completion of evaluation needed
for this document. Acephate is not currently registered for use on macadamia
nuts.
27
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Tolerances (ppm) (Continued)
Cormodity
United States Mexico International (Codex)"
Sheep (fat, meat,
meat byproducts)
Soybeans
Soybean meal
0.1
1
4
0.5
Sugar beet, leaves — —
Sugar beet, roots — —
Tcmatoes — 4
Watermelons — 5
£/
Processed foods 0.02 (FA)
10
0.1
5
—
a Numbers represent combined residues of acephate and methamidophos, whereas
numbers in parentheses represent the maximum residues (in ppm) of methamidophos.
b All Codex MRLs are Step 7.
c Due to treatment of food handling establishments.
d Unspecified whether seed, oil, meal, hulls, or any combination thereof.
28
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Table 2. Tolerance changes reflecting the recommended change In residue definition.
Acephate
Methamldophos
Commodity
Beans (succulent
and dry forms)
Brussels sprouts
Cauliflower
Celery
Cottonseed
Cranberries
Eggs
Fat, meat, and
meat byproductsd
Grass (pasture and
range)
Grass hay
Lettuce (head)
Milk
Mint hay
Peanuts
Peanuts hulls
Peppers
Soybeans
Cottonseed hullsS
Cottonseed mealS
Soybean mealfi
Processed foods*1
Established
tolerance ( ppm )a
3(1)
3(0.5)
2(0.5)
10(1)
2
0.5(0.1)
0.1
0.1
15
15
10(1)
0.1
15(1)
0.2
5
4(1)
1
4
8
4
0.02
Recommended
tolerance(ppm)b
3
3
2
10
2
0.5
0.1
0.1
15
15
10
0.1
15
0.2
5
4
1
4
8
4
0.02
Established
tolerance ( ppm ) c
—
1
1
1
0.1
ie
—
If
—
Recommended
tolerance ( ppm) c
1
1
1
1
0.5
0.1
0.01
0.01
3
3
1
0.05
1
0.1
1.5
1
0.2
0.1
2.5
2
— —
Expressed in terms of combined residues of acephate and methamidophos. If specified, limits of
methamidophos are given parenthetically.
b Expressed in terms of acephate per ae only.
c Expressed in terms of only methamidophos per se.
d Included are cattle, goats, hogs, horses, poultry, and sheep.
e The methamidophos tolerance covers all types of lettuce (head and leaf).
f The methamidophos tolerance covers all types of peppers.
g Peed additive tolerances in 21 CPR 561.20 (acephate) and recommendations for inclusion under 21 CPR 561.277
(methamidophos).
h Food additive tolerance reflecting spot and crack and crevice treatment of food areas of food handling
establishments (21 CFR 193.10). There is no expectation of methamidophos residues in such foods
(residues were nondetectable, <0.001 ppm, in all cases).
*This table does not include the tolerance of acephate In/on macadamla nuts (.05 ppm) which was established subsequent
to completion of evaluation needed for this document. Acephate is not currently registered on macadamia nuts.
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TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: ACEPHATE
Guideline Citation and
Name of Test
§158.120 Product Chemistry
Product Identity:
and Manufacturing Process
61—3 Discussion of FotYiitition of
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
Test
Substance
ils TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Guidelines
Status
R
R
CR
R
R
R
R
R
Are Data Footnote
Required Number
Yes No
[x] n 4
[x] T] 4
[x] t~] 5
Cxi [~]
[x] [~]
[x] [~3
[x] C~]
O [x] 2
Data Must Be
Submitted Within
Tlmef rame Listed
Below I/
6 Months
6 Months
12 Months
6 Months
6 Months
6 Months
6 Months
30
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TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: ACEPHATE
Guideline Citation and
Name of Test
Test
Substance
Guidelines
Status
Are Data
Required
Yes No
Footnote
Number
Data must Be
Submitted Within
Timeframe Listed
Below I/
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-7 - Density, Bulk Density, or
Specific Gravity
63-8 - Solubility
63-9 - Vapor Pressure
63-10 - Dissociation constant
63-11 - Octanol/water partition
coefficient
63-12 - pH
63-13 - Stability
Other Requirements;
64- 1 - Submittal of samples
TGAI
TGAI or PAI
PAI
PAI
PAI
TGAI
TGAI
TGAI, PAI
R
R
R
R
R
R
R
CR
[x]
[x]
[x]
O
[x]
[x]
n
[J
[J
n
[J
[x]
n
n
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
TGAI = Technical Grade of the Active Ingredient; PAI = Pure Active Ingredient; R = Required; CR = Conditionally Required
I/ Data must be submitted within the indicated tlmefrarne, based on the date of the Guidance Document.
0 6 Month Due Date is April 30, 1986 .
0 12 Month Due Date is October 31, 1986 .
2/ Data not required becauseTthe 97% technical material Is solid at room temperature.
3/ Data not required because acephate is a polar compound.
][/ A description of the new manufacturing process yielding methylthioacetate (MTA) as an impurity, including purities of
starting materials, reaction conditions, and any purification and quality control steps must be submitted.
5/ Analysis of five or more representative batches from the altered process for any impurity present at >Q.l% by weight,
MTA, and any other highly toxic and/or mutagenic/oncogenlc impurity whether above or below 0.156 (w:w) including
descriptions and validation of the analytical procedures used must be submitted.
31
-------
GENERIC DATA REQUIREMENTS FOR ACEPHATE
Data Requirements
Composition
Does EPA Have Data
To Satisfy This
_!/ Requirement? (Yes,
No, or Partially)
Bibliographic
CitationlS/
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Tlmeframe For Data
Submission 2/
§158.125 Residue Chemistry
171-2 - Chemical Identity
171-3 - Directions for Use
171-4 - Nature of Residue (Metabolism)
- Plants
TGAI
NA
PAIRA
Partially
Yes
- Livestock
171-4 - Residue Analytical Method
- Plant residues
- Animal residues
171-4 - Magnitude of the Residue-
Residue Studies for Each
Food Use
- Crop Group #1 - Legume Vegetables
(succulent or dried)
o Crop 1 Beans - (dry and
succulent incl.
lima beans)
PAIRA and Plant
Metabolites
TGAI and Metabolites
TGAI and Metabolites
Yes
Yes
Yes
TEP
Partially
NA
YesV 6 Months
Yes5/ 6 Months
00015187, 00015203 No
05007862, 00015188
00014990, 00015210
00014989
00015222; 00014555 No
00014729, 00014579 No
00014659, 00014983
GS0042001
00014729 No
00014791, 00014787
00014774, 00014775 YesW 24 months
00014778, 00014777 ~
00014776, 00014540
00014780, 00014781
00014783, 00014541
00014782, GS0042004
32
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TABLE A
GENERIC DATA REQUIREMENTS FOR ACEPHATE
V
Data Requirements
Composition
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No, or Partially)
Bibliographic
Citation13/
Must Additional Data
Be Submitted Under
FIFRA § 3(c) (2MB)?
Timeframe For Data
Submission 2/
§158.125 Residue Chemistry - Continued
171-4 - Magnitude of the Residue
Residue Studies (continued)
o Crop 2 - Soybeans TEP Partially 00014534,
00014532,
00015049,
- Crop Group #2 - Leafy
Vegetables (Except Brassica)
o Crop 1 - Celery TEP Partially 00014770,
00014772,
00015326,
00015323,
00015324,
00014769,
00014768,
o Crop 2 - lettuce (Crisp TEP Partially 00015190,
head type) 00015192,
00015194,
00014533 Yes10/ 24 Months
00015050
00015060
00014771 Yes6/ 24 months
00014773
00015325
00015328
00015327
00015329
GS0042005
00015191 Yes6/ 24 month
00015193
00015293
00015294, 00014971
00015042, GS0042002
GS0042003
o Crop Group #3 - Brassica
(cole) Leafy Vegetables
o Crop 1 - Brussels Sprouts
TEP
Yes
GS0042006; GS0042002
GS0042003
o Crop 2 - Cauliflower
TEP
Yes
GS0042007
No
33
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TABLE A
GENERIC DATA REQUIREMENTS FOR ACEPHATE
V
Data Requirement
Composition
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation13/
Must Additional Data
Be Submitted Under
FIFRA § 3(c) (2)(B)?
Timeframe for Data
Submission 2/
§158.125 Residue Chemistry - Continued
171-4 - Magnitude of the Residue
Residue Studies (continued)
- Crop Group #4 - Fruiting
Vegetables (except cucurbits)
o Crop 1 - Peppers
Crop Group #5 - Grass
Forage, Fodder, and Hay
o Crop 1 - Grass (pasture
and range)
o Crop 2 - Grass Hay
Crop Group #6 - Small
Fruits annd Berries
o Crop 1 - Cranberries
TEP
Yes
TEP
TEP
Partially
Partially
00014765, 00014760
00014762, 00014763
00014764, GS0042008
GS0042047
No
GS0042009
GS0042009
TEP
Yes
GS0042010
Yesf/7/
24 months
24 months
No
34
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TABLE A
GENERIC DATA REQUIREMENTS FOR ACEPHATE
Data Requirements
Composition"
Does EPA Have Data
To Satisfy This
I/ Requirement? (Yes,
No, or Partially)
Bibliographic
Citationl3/
Must Additional Data
Be Submitted Under
PIPRA § 3(c)(2)(B)?
Timeframe For Data
Submission 2/
§158.125 Residue Chemistry - Continued
171-4 - Magnitude of the Residue
Residue Studies (continued)
- Miscellaneous Crops
o Crop 1 - Cotton
TEP
Partially
o Crop 2 - Mint Hay
(peppermint and spearmint)
o Crop 3 - Peanuts
TEP
TEP
Partially
Yes
00015199, 00015198 Yes6/ 24 months
00015206, 00014852
00015038, 00014854
00015206, 00014855
00015196, 00014853
00029683, GS0042048 YesT/ 24 months
GS0042011 No
35
-------
XAOLC. H.
GENERIC DATA REQUIREMENTS FOR ACEPHATE
Data Requirements
Compositlorf
Does EPA Have Data
To Satisfy This
I/ Requirement? (Yes,
No, or Partially)
Bibliographic
Citationl3/
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)7
Tlmeframe For Data
Submission 2/
§158.125 Residue Chemistry - Continued
171-4 - Magnitude of the Residue
Residue Studies (continued)
- Meat/Milk/Poultry/Eggs
- Potable Water
- Fish
- Irrigated Crops
- Food Handling
171-5 - Reduction of Residue
TGAI or Plant Partially
Metabolites
EP N/A
EP N/A
EP No
EP Yes
Residue of No
Concern
GS0042015
00015183 Yes&V !&/ 18 Months
00015225
00015222
00015230
00015245
NtA5/
GS0042013 No9/
GS0042014
YeslO/ 24 Months
171-6 - Proposed Tolerance3/ll/
171-7 - Reasonable Grounds
Support of Petition
171-11 - Tobacco
171-13 - Submittal of Analytical^/
Reference Standards
TEP
Partially
05014159
00015122
00015125
GS0042012
Yes8/ 24 months
36
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TABLE A
8 GENERIC DATA REQUIREMENTS FOR ACEPHATE
§158.125 Residue Chemistry - Continued
I/ Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radlolabelled; TEP =
Typical end-use product; EP = End-use product; Residue of concern = acephate and methamidophos have been identified
as the residues of concern resulting from application of acephate.
2/ Data must be submitted within the indicated timeframe, based on the date of the Guidance Document.
0 6 Month Due Date is April 30, 1986 .
0 18 Month Due Date is April 30, 1987 .
0 24 Month Due Date is October 31, 1987.
3/ Includes filing fee.
V The same chemical identity data as required under §158.120 are required, with emphasis on Impurities
that could constitute a residue problem.
5/ Refer to Chapter II. F3f, of this document for the required interim use restriction statements for peppermint,
spearmint, pasture, and rangeland.
6/ The available data (GS0042002 and GS0042003) suggest that the stability of acephate residues upon frozen storage
is dependent upon the stored, treated commodity. Of the six crops tested, only lettuce and brussels sprouts have
been assigned acephate tolerances. No data are available concerning residue stability in stored animal products.
We do not feel that the tested commodities are representative of all crops regulated for acephate tolerances,
especially In light of the erratic lettuce storage data. We, therefore, cite the following data gap which must
be satisfied,
o Weathered residues of acephate and methamidophos must be determined in and on the following commodities immediately
prior to storage and at Intervals approximating the maximum period of storage at subfreezing temperatures: beans,
celery, cottonseed, grass, and lettuce. In addition, eggs, milk and animal tissues must be similarly tested.
77 It is estimated that, based on available residue data, the established tolerance level for acephate residues in milk
are likely to be exceeded if maximum levels of spent mint hay or grass hay are included In the dairy animal diet.
To ensure that the established tolerance level in milk will not be exceeded the following data must be submitted to
maintain continued registration of the use of acephate on mint (spearmint and peppermint) and pasture and rangeland:
-------
TABLE A
9 GENERIC DATA REQUIREMENTS FOR ACEPHATE
§158.125 Residue Chemistry - Continued
L/Cont.
Mint
Submit additional mint hay residue data supporting a lower tolerance.
Pasture and rangeland
Submit additional residue data on hay supporting a lower tolerance.
Q/ Tobacco residue data generated from aerial applications of acephate are required.
9/ These data are sufficient to support the current established food additive tolerance for use of
acephate in food handling establishments under 21 CPR 193. Additional data and a proposed
tolerance under 21 CPR 561 would be required to support use of acephate in food areas of feed handling
establishments. The current registered use of acephate in food areas of food handling establishments Is
restricted for use in food (as opposed to feed) handling establishments.
10/ Residue data on food prepared for consumption for the following commodities are needed to estimate
actual dietary exposure to residues of acephate and its metabolite, methamidophos from consumption
of these foods.
Beans, succulent: Available canning data are quite variable for residues of both acephate and
methamidophos and, in addition, sampling was inadequate. Canning does, however, appear to be a potential
route of dietary exposure reduction. No cooking (boiling) data are available on beans. Therefore,
the following data must be submitted to estimate actual dietary exposure to succulent beans:
o Cooking (boiling) of succulent green beans according to common consumer practices. Beans must bear
field-weathered, detectable residues of acephate and methamidophos. Beans must be analyzed both
before and after cooking. Cooking water should also be analyzed.
o Commercial processing (canning) of fieId-treated, succulent green beans bearing detectable
residues of acephate and methamidophos. Beans must be analyzed both before and after canning.
Canning water should also be analyzed.
Beans, dried; No canning or cooking data are available. Data are insufficient to support an increase
in the PHI, if desired. The following data are required to estimate the actual dietary exposure to residues
in dry beans:
38
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TABLE A
10 GENERIC DATA REQUIREMENTS FOR ACEPHATE
§158.125 Residue Chemistry - Continued
o Pinto and/or navy beans must be field-treated with the 75% soluble concentrate/solid formulation
(SC/S) six times at 1 Ib ai/A. Beans are to be allowed to dry normally, and then both boiled and
canned, in separate tests, according to typical home or commercial preparation procedures.
Cooking fluid and beans must be analyzed both before and after boiling and canning for residues of
acephate and its metabolite metharnidophos.
Soybean oil; The available processing data are not adequate to estimate the dietary exposure due to
consumption of soybean oil.
Acephate residues in crude oil may be present _< 33% of the concentration in or on soybean seed.
Cottonseed data indicate that further reductions in residues would occur upon refining the crude oil
but data are insufficient to make a reliable estimation. Therefore, the following data must be submitted.
o A determination of residues of acephate and methamidophos in crude oil and refined oil.
Soybean, defatted flour: There are no data available on the degree of concentration (or reduction) of
residues of acephate and methamidophos in defatted flour, which is used as a component of infant formula.
A four-fold residue concentration generally occurs upon processing soybeans to soybean meal (and, presumably,
defatted flour), as reflected by the 1.0 ppm vs. 4 ppm tolerances in or on seed vs. meal, respectively.
Defatted flour is similar to soybean meal but has not been toasted and is more finely ground. Therefore,
the following study must be submitted to refine the estimated dietary exposure due to consumption of defatted
soybean flour.
o A determination of the degree of concentration (or reduction) of acephate and methamidophos upon processing
soybeans (containing field-weathered residues) to defatted flour.
ll/ No new tolerance proposals are required to be submitted to support registered uses of acephate
as described in this document.
12/ The rationale of how the residue data support the proposed tolerance is required to be submitted
with any proposed tolerance(s). As specified in footnote 11 above, no new tolerance proposals
are required.
39
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TABLE A
11 GENERIC DATA REQUIREMENTS FDR ACEPHATE
§158.123 Residue Chemistry - Continued
137 Where there are more than one bibliographic data citation listed for a data requirement, each
study by itself only partially satisfies that data requirement.
IV Submittal of reference standards are required to be submitted for new pesticides and thus would
not need to be submitted for acephate.
15/ These data are not required because the registered use of acephate as described In this document
indicate that crops are not irrigated with acephate treated water.
16/ Milk: Dairy products contribute H.2 - 26.1% of the ADI, depending on the population under consideration.
The Tolerance Assessment System (TAS) recognizes three milk fractions: nonfat milk solids, milkfat solids, and milk
sugar (lactose). However, no data are available concerning the fate of residues upon pasteurization or processing
into the fractions noted above. The following data are required for an actual exposure assessment:
o A dairy cattle feeding study must be conducted in which cattle are fed acephate and methamidophos at an
approximately 5:1 ratio in the diet. The feeding level should be high enough to result in detectable residues
of both acephate and methamidophos In milk. Exaggerated rates would be advantageous. Residues of acephate
and methamidophos must be determined in whole raw milk (containing detectable residues of each compound),
pasteurized milk, and in nonfat milk solids, milkfat solids, and possibly milk sugar (lactose).
40
-------
12
TABLE A
GENERIC DATA REQUIREMENTS FOR ACEPHATE
I/
Data Requirement Composition
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis TGAI or PAIRA
Photodegradation
161-2 - In water TGAI or PAIRA
161-3 - On soil TGAI or PAIRA
161-4 - In Air TGAI or PAIRA
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil TGAI or PAIRA
162-2 - Anaerobic Soil TGAI or PAIRA
162-3 - Anaerobic Aquatic TGAI or PAIRA
162-4 - Aerobic Aquatic TGAI or PAIRA
MOBILITY STUDIES:
163-1 - Leaching and TGAI or PAIRA
Adsorption/Desorption
163-2 - Volatility (Lab) TEP
163-3 - Volatility (Field) TEP
Does EPA Have
Data To Satisfy
Use 2/ This Require-
Pattern ment? (Yes, No
or Partially)
A,B,C,F,G,H Partially
A,B,C,G Yes
A,B,C,G No
A,B,C No
A,B,F,H Yes
A, B Yes
C,G No
C Yes
A,B,C,F,G,H Partially
A,B,F No
A,B,F No
Bibliographic
Citation 11/
00014986
00014987
00015202
—
—
00014991
00014991
—
00014988
05018064
00015209
00015213
00014992
00015212
—
—
Must Additional Data
Be Submitted Under
FIFRA § 3(c) (2) (B)?
Timeframe for Data
Submission •*/
Yes10/ 9
No
Yes 9
No4/
No
No
Yes 27
No
Yes£/ 1 2
No4/
No_4/
Months
Months
Months
Months
41
-------
13
J-ftDI il'i A
GENERIC DATA REQUIREMENTS FOR ACEPHATE
Data Requirement
I/ Use 2/
Composition Pattern
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Cltationll/
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Timeframe for Data
Submission 3/
§158.130 Environmental Pate - Continued
DISSIPATION STUDIES-FIELD:
164-1 -
164-2 -
164-3 -
Soil
Aquatic (Sediment)
Forestry
TEP
TEP
TEP
A,B,H
C
G
No
Partially
Yes
Yes
00015221 Yes6_/
00014637, 00029738 No
27 Months
27 Months
164-4 - Combination and
Tank Mixes12/
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
165-5 - In Aquatic Nontarget
Organisms
TEP A,B,C,G,H
PAIRA A
TEP A
TEP
TCAI or PAIRA A,B,C,G
TEP G
No
Partially
No
No
Yes
Yes
00014638, 05015409
00014642
00014635
00015210
00015243
Reserved7/
Yesl3/ 39 Months
Reserved^/
No9/
No
00014637, 00014496 No
00014638, 00015242
00014642
00014635
42
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ACEPHATE
14
§158.130 Environmental Fate - Continued
I/ Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radlolabelled;
TEP = Typical end-use product.
21 The use patterns are coded as follows: A = Terrestrial, Pood Crop; B = Terrestrial, Nonfood; C = Aquatic,
Pood Crop; D = Aquatic, Nonfood; E = Greenhouse, Pood Crop; P - Greenhouse, Nonfood; G = Forestry;
H = Domestic Outdoor; I = Indoor.
37 Data must be submitted within the indicated tlmeframe, based on the date of the Guidance Document.
0 9 Month Due Date is July 31,1986 .
0 12 Month Due Date is October 31, 1986 .
0 27 Month Due Date is January 31, 1988 .
0 39 Month Due Date is January §1, 1989 .
4/ These data are not required because of the low vapor pressure of acephate.
57 Adsorption/desorption data must be submitted.
\/ Aquatic field dissipation data reflecting the registered use of acephate on cranberries are required.
If The Agency will determine whether this study is required based on an evaluation of the dissipation
studies required in 164-1 and 164-2 of this table. If required, the Agency will notify the registrant and will
provide a time frame for submittal of the study which will be 49 months from date of notification.
87 The Agency will determine whether this study is required based on an evaluation of the confined rotational
crop data required in 165-1 of this table. If required, the Agency will notify the registrant and will provide
a time frame for submittal of the study which will be 50 months from date of notification.
97 These data are not required because the current registered use patterns as described in this Document
indicate that crops are not Irrigated with acephate-treated water.
107 This study would satisfy the data requirement if documentation proving it was done with sterile (bacteria-
free) water can be provided by the registrant.
ll/ Where there is more than one bibliographic data citation listed for a data requirement, each study by
itself only partially satisfies that data requirement.
12/ These data are not required because this Document only addresses single active ingredient products.
137 These data are required for leafy vegetable crops.
43
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15
TABLE A
GENERIC DATA REQUIREMENTS FOR ACEPHATE
Does EPA Have Must Additional Data
Data To Satisfy Be Submitted Under
I/ Use 2/ This Require- Bibliographic PIPRA § 3(c)(2)(B)?
Data Requirement Composition Pattern ment? (Yes, No Citation ll/ Timeframe for Data
or Partially) Submission 3/
§158.135 Toxicology
ACUTE TESTING:
81-1
81-2
81-3
81-7
- Acute Oral Toxicity - Rat TGAI A,B,C,F,G,H,I
- Acute Dermal Toxicity TGAI A,B,C,F,G,H,I
- Rabbit
- Acute Inhalation Toxicity TGAI A,B,C,F,G,H,I
- Rat
- Delayed TGAI A,B,C,F,G,H,I
Neurotoxicity - Hen
Yes
Yes
Yes
No
00014675 No
00029696
00014681 No
GS0042023
00015307 No
Yes
12 Months
SUBCHRONIC TESTING:
82-1
82-2
82-3
82-4
82-5
- 90-Day Feeding : TGAI
- Rodent, and
- Nonrodent (Dog)
- 21-Day Dermal - Rabbit TGAI
- 90-Day Dermal - Rabbit TGAI
- 90-Day Inhalation: TGAI Tobacco
- Rat
- 90-Day Neurotoxicity: TGAI A,B,C,F,G,H,I
- Hen
-Mammal
No
No
Yes
No
No
No
No
NoV
NoV
GS0042045 No
NoV
,es6/
Reserved?/
Reserved?/
6 Months
(Protocol)
44
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TABLE A
GENERIC DATA REQUIREMENTS FOR ACEPHATE
Data Requirement
I/ Use 2/
Composition Pattern
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation ll/
Must Additional Data
Be Submitted Under
PIFRA § 3(c)(2)(B)?
Timeframe for Data
Submission 3/
§1^8.135 Toxicology - Continued
CHRONIC TESTING:
83-1 - Chronic Toxiclty - TGAI A,C Yes
2 species:
- Rodent, and
- Nonrodent (Dog) A,C Yes
83-2 - Oncogenicity - TGAI A,B,C,P,G,H,I Yes
2 species:
- Rat (preferred), and
GS0042024
GS0042033
00014699
GS0042025
GS0042024
GS0042033
GS0042032
No
No
No
- Mouse (preferred)
83-3 - Teratogenicity - TGAI
2 species:
- Rat
- Rabbit
83-4 - Reproduction - Rat TGAI
2-generation
MUTAGENICITY TESTING
84-2 - Gene Mutation (Ames Test) TGAI
84-2 - Structural Chromosomal TGAI
Aberration
84-4 - Other Genotoxic Effects TGAI
A,B,C,P,G,H,I Yes
A,C,I Yes
A,C,I Yes
A,C No
A,B,C,P,G,H,I Yes
A,B,C,F,G,H,I Yes
A,B,C,F,G,H,I Yes
GS0042026, GS0042030 No
GS0042027, GS0042031
GS0042029,
00014695
GS0042028
No
No
YeslO/ 39 Months
GS0042038, 00028625 No
GS0042040 No
GS0042039
No
45
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TABLE A
GENERIC DATA REQUIREMENTS FOR ACEPHATE
Data Requirement
I/ Use 2f
Composition Pattern
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation ll/
Must Additional Data
Be Submitted Under
PIFRA § 3(c)(2)(B)?
Timeframe for Data
Submission 3/
§158,135 Toxicology - Continued
SPECIAL TESTING
85-1 - General Metabolism
85-2 - Dermal Penetration
86-1 - Domestic Animal
Safety
PAI or PAIRA
Choice
Choice
A,C
Yes
00014219
00014518
00014994
A,B,C,P,G,H,I No
No
Yes8/
No9/
6 Months
(Protocol)
46
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TABLE A
18 GENERIC DATA REQUIREMENTS FOR ACEPHATE
§158.135 Toxicology - Continued
I/ Composition: PAI = Pure active ingredient; PAIRA = Pure active ingredient, radiolabelled; Choice = Choice of several
test substances determined on a case-by-case basis.
2/ The use patterns are coded as follows: A = Terrestrial, Pood Crop; B = Terrestrial, Nonfood; C = Aquatic,
Pood Crop; D = Aquatic, Nonfood; E = Greenhouse, Pood Crop; P = Greenhouse, Nonfood; G = Forestry; H = Domestic
Outdoor; I = Indoor.
3/ Data must be submitted within the indicated timeframe, based on the date of the Guidance Document.
0 6 Month Due Date is April 30, 1986 .
0 12 Month Due Date is October 31, 19»6 .
0 39 Month Due Date is January 31 > 1989 .
V These data are not needed to support registration of acephate because the available 28-month rat feeding and the
2-year dog feeding studies (83-1) are adequate to assess human exposure via the oral route.
5/ This study is not required to support registration of the current use pattern of acephate as described in
this Document.
6/ This study is required to assess the exposure of man to the residue remaining at the time of use of tobacco.
The proposed protocol must be submitted within 6 months. The study must be submitted within 15 months from
date of acceptance of the protocol by the Agency.
7/ The Agency will determine whether these studies are required based on an evaluation of the acute neurotoxicity
study requested in 81-7 of this table. If required, the Agency will notify the registrant and will provide a
time frame for submittal of the study which will be 15 months from date of notification.
8/ The proposed protocol must be submitted within 6 months. The study must be submitted within 6 months
from date of acceptance of the protocol by the Agency.
9/ These data are not required to support registration of the current registered uses of acephate as
described in this Document.
10/ Though a rat reproduction study has been submitted, it is not acceptable to support registration because
a NOEL (non-observable-effect level) was not determined i.e., various effects on reproduction were observed in
rats that were fed 50 ppm of the test material, the lowest dose level fed. Therefore, a new reproduction study
using lower dose levels is needed in order to determine a definite NOEL for reproductive effects.
ll/ Where there are more than one bibliographic data citation listed for a data requirement, each study by itself
only partially satisfies that data requirement.
47
-------
19
TABLE A
GENERIC DATA REQUIREMENTS FOR ACEPHATE
I/
Data Requirement Composition
§158.140 Reentry Protection
132-1 - Foliar Dissipation TEP
132-1 - Soil Dissipation TEP
133-3 - Dermal Exposure TEP
133-4 - Inhalation Exposure TEP
§158.142 Spray Drift
201-1 - Droplet Size Spectrum TEPfy
201-1 - Drift Field Evaluation TEP6/
Exposure Assessment Studies TEP
Glove Permeability Study TEP9/
I/ Composition: TEP = Typical end-use product.
Use
Pattern
A,B,C,G
A
A,B,C,G
A,B,C,G
A,B,C,G
A,B,C,G
B,F,G,H
—
Does EPA Have
Data To Satisfy
2/ This Require-
ment? (Yes, No
or Partially)
Partially
No
Partially
Partially
No
No
,1 No
No
Must Additional Data
Be Submitted Under
Bibliographic FIFRA § 3(c)(2)(B)?
Citation Timeframe for Data
Submission 3/
00015241 Yes7/ 27 Months
05007862
YesV 27 Months
00015241 Reserved^/
00015241 Reserved^/
Yesfy 6 Months
Yes6/ 6 Months
YesV 6 Months
(Protocol)
Yes9/ 6 Months
(Protocol)
2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Nonfood; C = Aquatic,
Food Crop; D = Aquatic, Nonfood; E = Greenhouse, Food
H = Domestic Outdoor; I = Indoor.
3/ Data must be submitted within the indicated
0 6 Month Due Date is April 30, 1986 .
0 27 Month Due Date is January 31, 1988 .
timeframe
Crop; F = Greenhouse,
, based on the date of
Nonfood; G = Forestry;
the Guidance Document.
V Soil dissipation data are required for use on peanuts because the registered use of acephate on peanuts
as described in this Document involves human tasks that could cause human exposure to residue adsorbed to soil.
-------
TABLE A
20 GENERIC DATA REQUIREMENTS FOR ACEPHATE
Data Requirement
I/ Use 21
Composition Pattern
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Timeframe for Data
Submission 3/
§158.140 Reentry Protection - Continued
5/ Studies of potential applicator exposure must be conducted. Outdoor studies must include forestry application,
application to tobacco, and to both home and commercial ornamentals. The material must be applied to home ornamentals
using a hand compressed air or hose-end sprayer. In addition, studies of indoor exposure of applicators and inhabitants
must be carried out for home, greenhouse, and commercial establishment applications. Home application must be by the
use of a ready to use pressurized spray. Commercial building application must be by a "coarse spray technique." The
postapplication decrease in exposure with time must be monitored.
The references cited below are to be used as guidelines for the exposure studies. The proposed protocol must
be submitted within 6 months. The studies must be submitted within 27 months from date of acceptance of the protocol
by the Agency.
The following general background documents are available to describe how monitoring studies and quantitative
exposure assessments are carried out:
1. Davis, James E. (1980) "Minimizing Occupational Exposure to Pesticides: Personnel Monitoring." Residue
Reviews 75: 33.
This review article describes state-of-the-art procedures for the actual field measurement of dermal and
respiratory exposure.
2. Severn, David J. (1982) "Exposure Assessment for Agricultural Chemicals" in Genetic Toxicology - An
Agricultural Perspective, R.D. Fleck and A. Hollaender, Eds., Plenum Press, New York, p. 235.
This paper presents an overview of how exposure assessments are carried out in EPA, including a discussion of the
use of surrogate exposure studies for assessments when no data are available for a particular pesticide.
3. Severn, David J. (1984) "Use of Exposure Data for Risk Assessment." in Determination and Assessment of
Pesticide Exposure, M. Siewierski, Ed., Elsevier Science Publishing Company, New York, p. 13
This paper describes in greater detail what assumptions are made and how exposure assessments are performed
in EPA.
4. Reinert, Joseph C. and Severn, David J. (1985) "Dermal Exposure to Pesticides: EPA's Viewpoint." in
Dermal Exposure Related to Pesticide Uses, R.C. Honeycutt, G. Zwelg, and N.N. Ragsdale Eds., American Society,
Washington, D.C., p. 357.
This paper is a synthesis of the methodologies and logistics used in preparing applicator exposure assessments
in EPA.
49
-------
TABLE A
21 GENERIC DATA REQUIREMENTS FOR ACEPHATE
Exposure Assessment Studies - Continued
Protocols must be submitted to the Agency for review prior to conduct of the studies. If more detailed guidance
is needed, or if specific questions related to any aspect of pesticide exposure assessment arise, contact:
Joseph C. Reinert, Ph.D., Chief
Special Review Section
Exposure Assessment Branch
Hazard Evaluation Division (TS-769C)
(703) 557-3935
67 The required studies may consist of either of the following or a combination thereof: (1) A reevaluation of existing
published or unpublished data when chemical properties, use patterns, and general geographic/meteorological situations
are similar to the proposed product, (2) An undertaking of the studies required in §158.142. Rather than conducting
these studies on acephate, the Agency is currently encouraging the submittal of surrogate studies, i.e., published or
unpublished information regarding spray drift patterns that would be expected to be similar to the acephate TEP. Refer
to Subdivision R of the Pesticide Assessment Guidelines In section 200-1(d).
77 Limited dislodgeable foliar data are available for cotton; dlslodgeable residue (decline curve) data are required for
cauliflower as a representative crop since, among the current crops registered for acephate as described in this
document, cauliflower is considered to be representative of a worst case in regards to the liklihood of human exposure
to residues by those involved in hand labor tasks.
8/ There are limited data available for use on cotton and it has been determined that this is sufficient given the Agency's
current knowledge of acephate. Should the Agency determine that results of the studies required under 132-1 and the
use-related exposure data warrant the need for these studies, they will be required. If required, the Agency will
notify the registrant and will provide a time frame for submittal of the study which will be 27 months from date of
notification. They may, however be submitted at the option of the registrant.
97 Glove permeability studies are required for all liquid formulations of end-use products. The permeability studies are
to be conducted as described in ASTM 739-81 Standard Test Method for Resistance of Protective Materials to Permeation
by Hazard Liquid Chemicals. The proposed protocol must be submitted within 6 months. The studies must be submitted
within 9 months from date of acceptance of the protocol by the Agency. Because the inerts could influence the
permeability of a formulation, studies are required to be submitted on a typical end-use liquid formulation
representative of a worse case scenario.
50
-------
22
GENERIC DATA REQUIREMENTS FOR ACEPHATE
I/ Use y
Data Requirement Composition Pattern
§158.145
Aquatic
AVIAN
70-1 -
71-1 -
71-2 -
71-3 -
71-4 -
71-5 -
-
Wildlife and
Organisms
AND MAMMALIAN TESTING
Special Test
- Avian Food Residue and TEP A,B
Enzyme Monitoring
Acute Avian Oral Toxicity TGAI A,B,C,G,H
Avian Subacute Dietary TGAI
Toxicity
- Upland Game Bird, and A,B,C,G,H
- Waterfowl A,B,C,G,H
Wild Mammal Toxicity TGAI
Avian Reproduction TGAI
- Upland Game Bird, and A,B,C,G
- Waterfowl A,B,C,G
Simulated Field Testing TEP
- Mammals, and A,B,G
- Birds A,B,G
Actual Field Testing TEP
- Mammals, and A,B,G
- Birds A,B,G
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
No
Yes
Yes
Yes
—
Yes
Yes
No
No
No
Partially
Bibliographic
Citation
—
00014700*
00014701*
00015962**
00015956
00015957
—
00029692
00029691
—
—
—
05014922 05017571
00014639 00014860
05019256 GS042019
05021173 GS042018
GS042017 GS042020
GS042022
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Tlmef rame for Data
Submission 3/
YesV
No
No
No
Nq8/
No
No
Reserved5/
Reserved^/
Reserved5/
Reserved5/
6 Months
(Protocol)
51
-------
23
TABLE A
GENERIC DATA REQUIREMENTS FOR ACEPHATE
Does EPA Have
Data To Satisfy
V Use 2/ This Require- Bibliographic
Data Requirement Composition Pattern ment? (Yes, No Citation
or Partially)
§158.145
Aquatic
Wildlife and
Organisms - Continued
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Timef rame for Data
Submission 3/
AQUATIC ORGANISM TESTING
72-1 -
72-2 -
72-3 -
Freshwater Fish Toxic ity TGAI
- Cold water Fish Species, A,B,C,G,H Yes
and
- Warm water Fish Species A,B,C,G,H Yes
Acute Toxiclty to TGAI A,B,C,G,H Yes
Freshwater Invertebrates
Acute Toxic ity to TGAI
Estuarine and Marine
Organisms
- Fish A,B,G No
- Mollusk A,B,G Partially
- Shrimp A,B,G Partially
05018314*
00014705*
GS0042016*
00014705*
GS0042016*
05012201*
GS0042016*
GS0042021*
00014713
00014711
No
No
No
No6/
Nq6/
No6/
72-4 - Fish Early Life Stage,
and
- Aquatic Invertebrate
Life-Cycle
TGAI
No7/
52
-------
24 TABLE A
GENERIC DATA REQUIREMENTS FOR ACEPHATE
Does EPA Have Must Additional Data
Data To Satisfy Be Submitted Under
I/ Use 2/ This Require- Bibliographic PIPRA § 3(c)(2)(B)?
Data Requirement Composition Pattern ment? (Yes, No Citation Timeframe for Data
or Partially) Submission 3/
§158.145 Wildlife and
Aquatic Organisms - Continued
72-5 - Pish - Life-Cycle TGAI NoT/
72-6 - Aquatic Organism TGAI, PAI or
Accumulation Degradation
Product
- Crustacean NoTV
- Pish NoT/
- Insect Nymph NqJ_/
- Mollusk NoT/
72-7 - Simulated Field Testing TEP NoT/
- Aquatic Organisms
- Actual Field Testing NoT/
-Aquatic Organisms
53
-------
25 TABLE A
GENERIC DATA REQUIREMENTS FOR ACEPHATE
§158.145 Wildlife and Aquatic Organisms - Continued
I/ Composition: TCAI = Technical grade of the active ingredient; PAI = pure active ingredient;
TEP = Typical end-use product;
2/ The use patterns are coded as follows: A = Terrestrial, Pood Crop; B = Terrestrial, Nonfood Crop; C = Aquatic,
Pood Crop; D = Aquatic, Nonfood; E = Greenhouse, Pood Crop; P = Greenhouse, Nonfood; G = Forestry;
H = Domestic Outdoor; I = Indoor.
_3/ Data must be submitted within the Indicated timeframe, baaed on the date of the Guidance Document.
0 6 Month Due Date is April 30, 1986 .
V These data are necessary to support a hazard assessment for the multiple-application, high use-rate field crops.
The data must: (1) address the occurrence of acephate-methamldophos in potential wildlife food
items at maximum treatment rates under realistic repeat application conditions, and (2) monitor a biological
index of toxic effects such as brain ChE in exposed birds. The proposed protocol must be submitted within
6 months. The study must be submitted within 19 months from date of acceptance of the protocol by the Agency.
The following references may be useful in designing the monitoring study:
0 Niethammer, K.R. and T.S. Basket. 1983. Chollnesterase Inhibition of Birds Inhabiting Wheat Fields Treated
with Methyl Parathion. Arch. Environ. Contam. Toxicol.12, 471-475.
0 Bunyan, P.J., M.J. Van Den Heuvel, P.I. Stanley, and E.N. Wright. 1981. An intensive field trial and a
multi-site surveillance exercise on the use of aldicarb to Investigate methods for the assessment of
possible environmental hazards presented by new pesticides. Agro Ecoystems 7: 239-262.
57 The Agency will determine whether these data are required based on an evaluation of the avian residue monitoring
studies requested In 70-1 of this table. If required, the Agency will notify the registrant and will provide a
tlmeframe for submittal of the data which will be from 24 to 48 months from date of notification, depending on
testing required.
6/ These data are not required to support current registered uses of acephate based on the demonstrated low acute
toxicity to fish. However, the two studies cited have been reviewed and used in the hazard assessment of acephate.
7/ Based on the demonstrated low acute toxicity to aquatic organisms and the current registered use patterns of
acephate, these data are not required.
8/ This study is only required on a case-by-case basis. In the case with acephate, the rat toxicity
data submitted under 40 CPR 158.135 are sufficient.
* Study by itself satisfies the data requirement.
** Study by itself only partially satisfies the data requirement.
-------
26
TABLE A
GENERIC DATA REQUIREMENTS FOR ACEPHATE
Data Requirement
I/ Use 2/
Composition Pattern
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Timef rame for Data
Submission 3/
§158.150 Plant Protection
121-1 - TARGET AREA EP
PHYTOTOXICITY
NONTARGET AREA PHYTQTOXICITY
TIER I
122-1 - Seed Germination/ TGAI
Seedling Emergence
122-1 - Vegetative Vigor TGAI
122-2 - Aquatic Plant Growth TGAI
TIER II
123-1 - Seed Germination/ TGAI
Seedling Emergence
123-1 - Vegetative Vigor TGAI
123-2 - Aquatic Plant Growth TGAI
TIER III
124-1 - Terrestrial Field TEP
124-2 - Aquatic Field TEP
3/
I/
I/
I/
I/
I/
I/
3/
I/ Composition: TGAI = Technical grade of the active ingredient; TEP = Typical end-use product. EP = End-use product.
2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Nonfood Crop; C = Aquatic,
Food Crop; D = Aquatic, Nonfood; E = Greenhouse, Food Crop; F = Greenhouse, Nonfood; G = Forestry;
H = Domestic Outdoor; I = Indoor.
3/ These data not required in accordance with §158.150.
55
-------
27
TABLE A
GENERIC DATA REQUIREMENTS FOR ACEPHATE
Data Requirement
I/ Use 2/
Composition Pattern
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
PIPRA § 3(c)(2)(B)?
Timeframe for Data
Submission 3/
§158«155 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORS;
141-1 - Honeybee acute
contact toxicity
141-2 - Honeybee - toxicity
of residues on
foliage
-4 - Honeybee subacute
feeding study
141-5 - Field testing for
pollinators
TGAI
TEP
A,B,C,G,H
A,B,C,G,H
Yes
Yes
00014714
00014715
No
No
(Reserved) 5/
TEP
No
No1*/
56
-------
28
TABLE A
GENERIC DATA REQUIREMENTS FOR ACEPHATE
Data Requirement
I/ Use 2/
Composition Pattern
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Timeframe for Data
Submission 3/
§158.155 Nontarget Insect - Continued
NONTARGET INSECT TESTING -
AQUATIC INSECTS;
142-1 - Acute toxicity to
aquatic insects
142-1 - Aquatic insect
life-cycle study
142-3 - Simulated or actual
field testing for
aquatic insects
143-1 - NONTARGET INSECT
TESTING - PREDATORS
thru
(Reserved)^/
(Reserved)^/
(Reserved)^/
(Reserved)6/
AND PARASITES
143-3
I/ Composition: TGAI = Technical grade of the active ingredient; TEP = Typical end-use product.
2/ The use patterns are coded as follows: A = Terrestrial, Pood Crop; B = Terrestrial, Nonfood; C = Aquatic,
Food Crop: D = Aquatic, Nonfood; E = Greenhouse, Food Crop; F = Greenhouse, Nonfood; G = Forestry;
H = Domestic Outdoor; I = Indoor.
3/ Data must be submitted within the indicated timeframe, based on the date of the Guidance Document.
4/ Results from lower tier study do not indicate the need for field testing.
5/ This requirement is reserved pending development of test methodology.
5/ This requirement is reserved pending further evaluation to determine what and when data should
be required, and to develop appropriate test methods.
57
-------
29
TABIE A
GENERIC DATA REQUIREMENTS FOR ACEPHATE
Data Requirement
I/ Use 2/
Composition Pattern
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Timef rame for Data
Submission 3/
Use Related-Exposure
TEP
A,B,F,G,H,I
No
Yes1*/ 6 Months
I/ Composition: TEP = Typical end-use product.
2/ The use patterns are coded as follows: A = Terrestrial, Pood Crop; B = Terrestrial, Nonfood; C = Aquatic,
Pood Crop: D = Aquatic, Nonfood; E = Greenhouse, Food Crop; F = Greenhouse, Nonfood; G = Forestry;
H = Domestic Outdoor; I = Indoor.
3/ Data must be submitted within the indicated timeframe, based on the date of the Guidance Document.
0 6-Month Due Date is April 30. 1986 .
_V The following data are required for the uses of acephate in forests; on domestic and commercial ornamentals;
cotton; lettuce; and for indoor uses in homes, greenhouses and commercial establishments.
a) Applicator types (homeowners, grower, PCO, etc.).
b) Rate ranges and most commonly used rate in active ingredient per unit.
c) Most commonly used formulations and package sizes with percentages of each.
d) Most commonly used carrier/diluent(s); report ratios.
e) Report methods of application (ground vs. air; band vs. broadcast; fixed boom vs. rope wick; etc.) and
projected percentages of each.
f) Report application timing in relation to crop growth and pest growth (life cycle). Report number of
applications and application intervals; report percent applied at each application (% preemergence
vs. % postemergence vs. % layby). Report timing of field operations (cultivation, thinning, harvesting,
etc.) in relation to pesticide applications) timing.
g) For pesticide(s) of concern, describe typical equipment and factors such as width of boom, volume per unit
application, speed of spraying equipment (MPH), tank size and type, normal operating pressure (PSI), nozzle
types, percent use of open vs. closed cabs, percent use of closed system transfer. (If preemergence,
describe if planting operation is commonly performed at the time of pesticide application.)
58
-------
TABLE A
30 GENERIC DATA REQUIREMENTS FOR ACEPHATE
Use Related Exposure - Continued
h) Describe if nurse tank is used; ferrying time and average distance to water source.
i) Calculate time required to spray out an average tank full of pesticide; and the total number of acres/unit
that can be treated in a typical work day.
j) Describe mixing/loading procedures commonly employed and numbers of mixers/loaders/applications (number of
each type) employed for the entire spray operation; describe if applicator and mixer/loader are the same
person, if not, give percentages of each type. Calculate actual mixer-loader pesticide exposure time;
excluding time spent to add diluent.
k) Describe preharvest; reentry intervals.
1) Describe proportion of grower vs. custom applicators and custom equipment types commonly employed.
m) Estimate total numbers of workers exposed per site/unit by type (applicators, mixer-loaders,
flaggers, etc.). If there are fetotoxic or teratogenic concerns, estimate number of females employed.
n) Describe protective clothing, equipment, and other currently employed means of pesticide exposure
avoidance.
o) Describe methods of pesticide and container disposal currently employed.
p) Estimate numbers of bystanders potentially exposed to spray or dust from treated fields.
q) Identify increased or reduced hazards associated with mixing-loading and applying alternative
chemicals. Identify any other hazards to farmworkers, bystanders, fish and wildlife, water supplies,
etc., associated with potential increased use if the review chemicals were not available.
59
-------
31
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING ACEPHATE
Guideline Citation and Test
Name of Test Substance
§158.120 Product Chemistry
Product Identity:
61-1 - Product Identity and Disclosure
of Ingredients
61-2 - Description of Beginning Materials
and Manufacturing Process
61-3 - Discussion of Formation of
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3 - Analytical Methods to Verify
Certified Limit
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-7 - Density, Bulk Density, or
Specific Gravity
63-12 - pH
63-14 - Oxidizing or Reducing
Action
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
Guidelines
Status
R
R
R
CR
R
R
R
R
R
R
CR
CR
Are Data Footnote
Required Number
Yes No
[x]
©
©
[x]
©
ra
©
©
[x]
ft]
[x]
[x]
n
n 6
["] 6
n ?
n
n 7
n
n
n
n
n
n
Data Must Be
Submitted Within
Tlmef rame Listed
Below I/
6 Months
6 Months
6 Months
12 Months
12 Months
12 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
fin
-------
32
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING ACEPHATE
Guideline Citation and
Name of Test
Test
Substance
Guidelines
Status
Are Data
Required
Yes No
Footnote
Number
Data Must Be
Submitted Within
Timeframe Listed
Below !/
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-15 - Flanmability MP
63-16 - Explodability MP
63-17 - Storage Stability MP
63-18 - Viscosity MP
63-19 - Miscibility MP
63-20 - Corrosion Characteristics MP
Other Requirements;
64- 1 - Submittal of samples MP
CR
R
R
CR
CR
R
CR
[x]
[x]
[x]
[x]
[x]
[x]
n
n
n
n
n
n
[x]
6 Months
6 Months
15 Months
6 Months
6 Months
15 Months
MP = Manufacturing-use Product; R = Required; CR = Conditionally Required
I/ Data must be submitted within the indicated timeframe, based on the date of the Guidance Document.
0 6 Month Due Date is April 30, 1986 .
0 12 Month Due Date is October 31, 1986 .
0 15 Month Due Date is January 31, 19B7 .
2/ Data required for MP's that are combustible liquids.
3/ Data required for MP's that contain an explosive Ingredient.
\l Data required for liquid MP's.
5/ Data required for MP's that are emulsifiable liquids.
\/ A description of the new manufacturing process yielding methylthloacetate (MTA) as an impurity, Including purities of
starting materials, reaction conditions, and any purification and quality control steps must be submitted.
7/ Analysis of five or more representative batches from the altered process for any impurity present at_>0.1/£ by weight,
MTA, and any other highly toxic and/or mutagenic/oncogenic Impurity whether above or below 0.1/5 (w:w) including
descriptions and validation of the analytical procedures must be submitted. The 97$, 85/5 and 75% MP's derived from
the new manufacturing process must all be analyzed. Confidential statements of formula must also be submitted for all
three products.
8/ Storage stability data to determine if MTA forms (or declines) in the 97%, 85/& and 75% MP's must be submitted.
62
-------
33
PRODUCT SPECIFIC DATA
TABLE B
FOR MANUFACTURING-USE PRODUCTS CONTAINING ACEPHATE (97/0
I/
Data Requirement Composition
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation^/ *
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Timeframe for Data
Submission 2/
§158.135 Toxicology
ACUTE TESTING
81-1
81-2
81-3
81-4
81-5
81-6
- Acute Oral Toxiclty - Rat
- Acute Dermal Toxlcity
- Rabbit
- Acute Inhalation Toxicity
- Rat
- Primary Eye
Irritation - Rabbit
- Primary Dermal
Irritation - Rabbit
- Dermal Sensitization -
MP
MP
MP
MP
MP
MP
Yes
Yes
Yes
Yes
Yes
Yes
00014675
00029696
00014681
GS0042023
00015307
00014686
00015305
GS0042037
No
No
No
No
No
No
Guinea Pig
62
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING ACEPHATE (8556)
I/
Data Requirement Composition
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
CitationV *
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Timef rame for Data
Submission 2/
§158.135 Toxicology
ACUTE TESTING
81-1
81-2
81-3
81-4
81-5
81-6
- Acute Oral Toxicity - Rat
- Acute Dermal Toxicity
- Rabbit
- Acute Inhalation Toxicity
- Rat
- Primary Eye
Irritation - Rabbit
- Primary Dermal
Irritation - Rabbit
- Dermal Sensitization -
MP
MP
MP
MP
MP
MP
Yes
Yes
Yes
Yes
Yes
Yes
GS0042042
00014681
GS0042023
00015307
GS0042041
00015305
GS0042043
GS0042037
No
NoV
No6/
No
No?/
No6/
Guinea Pig
63
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35
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING ACEPHATE (15%)
I/
Data Requirement Composition
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation^/ *
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Timef rame for Data
Submission 2/
§138.135 Toxicology
ACUTE TESTING
81-1
81-2
81-3
81-4
81-5
81-6
- Acute Oral Toxicity - Rat
- Acute Dermal Toxicity
- Rabbit
- Acute Inhalation Toxicity
- Rat
- Primary Eye
Irritation - Rabbit
- Primary Dermal
Irritation - Rabbit
- Dermal Sensitization -
MP
MP
MP
MP
MP
MP
Yes
Yes
Yes
Yes
Yes
Yes
GS0042042
00014681
GS0042023
GS0042046
GS0042044
GS0042043
GS0042037
No9/
Nq8/
No
No
No
No8/
Guinea Pig
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TABLE B
36 PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING ACEPHATE
§158.135 Toxicology - Continued
_!/ Composition: MP = Manufacturing-use product.
2/ Data must be submitted within the Indicated time frame, based on the date of the Guidance Document.
3/ These data are sufficient to support registration of the 97% MP currently registered.
¥/ These data are sufficient to support registration of the 85% MP currently registered.
5/ These data are sufficient to support registration of the 75% MP currently registered.
^/ Though these studies were conducted with the 97% MP, they are sufficient to support registration of the 85% MP.
]_/ Though these studies were conducted with the 97% MP (00015305) and 7555 (GS0042043), they are sufficient, when
taken together to support registration of the 85% MP.
8/ Though this study was conducted with the 97% MP, it is sufficient to support registration of the 75% MP.
9/ Though this study was conducted with the 85/6 MP, it is sufficient to support registration of the 75% MP.
* Where there are more than one bibliographic data citation listed for a data requirement, each study by itself
only partially satisfies that data requirement.
65
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37
TABLE C
PRODUCT SPECIFIC DATA REQUIREMENTS FOR END-USE PRODUCTS CONTAINING ACEPHATE
Data Requirement
I/ Use 2/
Composition Pattern
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Tlmeframe for Data
Submission 3/
Usage Data
TEP
A,B,F,G,H,I
No
Yes1*/ 6 Months
I/ Composition: TEP = Typical end-use product.
2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Nonfood; C = Aquatic,
Food Crop: D = Aquatic, Nonfood; E = Greenhouse, Food Crop; F = Greenhouse, Nonfood; G = Forestry;
H = Domestic Outdoor; I = Indoor.
3/ Data must be submitted within the Indicated timeframe, based on the date of the Guidance Document.
0 6-Month Due Date is April 30, 1986 .
V The following data are required for the uses of acephate in forests; on domestic and commercial ornamentals;
cotton; lettuce; and for indoor uses in homes, greenhouses, and commercial establishments.
a. Total acres/units treated by commodity (site) in U.S.
b. Lbs/gallon ai applied annually to each site and most commonly used application rate.
c. Geographic areas of use, by site.
d. Product end-use data. Describe commodity end-uses and estimate percentages of each. For example:
Percent of apples sold for fresh fruit, percent sold for processing (broken down by juice vs. applesauce).
e. Sales and production records Including container types and sizes and State sales.
66
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38
TABLE A
GENERIC DATA REQUIREMENTS FOR ACEPHATE'S IMPURITY, METHYLTHIOACETATE (MTA)
Does EPA Have
Data To Satisfy
I/ Use 2/ This Require-
Data Requirement Composition Pattern ment? (Yes, No
or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
PIPRA § 3(c)(2)(B)?
Tlmeframe for Data
Submission 3/
§158.135 Toxicology
ACUTE TESTING:
81-1
81-2
81-3
81-4
81-5
81-6
- Acute Oral Toxicity PI
- Rat
- Rabbit
- Acute Dermal Toxicity PI
- Rat
- Rabbit
- Acute Inhalation Toxicity PI
- Rat
- Primary Eye Irritation PI
- Rabbit
- Primary Dermal Irritiation PI
- Rabbit
- Dermal Sensitization PI
- Guinea Pig
A,B,C,F,G,H,I No
No
A,B,C,P,G,H,I
No
Partially
A,B,C,P,G,H,I
Partially
A,B,C,P,G,H,I
Yes
A,B,C,P,G,H,I
Yes
A,B,C,P,G,H,I
Yes
—
—
—
GS0042051
GS0042050
GS0042054;
GS0042055
GS0042052
GS0042053
V
Yes
V
Yes
5/
Yes
6/
Yes
11
Yes
No
No
No
9 Months
9 Months
9 Months
9 Months
9 Months
67
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39
GENERIC DATA
TABLE A
FOR ACEPHATE'S IMPURITY, METHYLTHIOACETATE (MTA)
17 Use 27
Data Requirement Composition Pattern
§158.135 Toxicology - Continued
SUBCHRONIC TESTING:
82-1 - 90-Day Feeding: PI A,B,C,P,G,H,I
- Rodent, and
- Nonrodent (Dog)
82-3 - 90-Day Dermal PI A,B,C,F,G,H,I
- Rabbit
82-4 - 90-Day Inhalation: PI A,B,C,F,G,H,I
- Rat
MUTAGENICITY TESTING
84-2 - Gene Mutation (Ames Test) PI A,B,C,F,G,H,I
84-2 - Structural Chromosomal PI A,B,C,P,G,H,I
Aberration
84-4 - Other Genotoxic Effects PI A,B,C,F,G,H,I
SPECIAL TESTING
- Neurophy Biological Studies PI A,B,C,F,G,H,I
of the Visual System
Does EPA Have
Data To Satisfy
This Require- Bibliographic
ment? (Yes, No Citation
or Partially)
No
No
No
No
Partially GS0042056
No
No
No
Must Additional Data
Be Submitted Under
PIPRA § 3(c)(2)(B)?
Timef rame for Data
Submission 37
87
Reserved
i/
Reserved
97
Yes 15 Months
107
Reserved
127
Yes 9 Months
Yes 12 Months
Yes 12 Months
Yes 6 Months
(Protocol)
68
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40
TABLE A
GENERIC DATA REQUIREMENTS FOR ACEPHATE'S IMPURITY, METHYLTHIOACETATE (MTA)
§158.135 Toxicology - Continued
I/ Composition: PI = Pure ingredient.
2/ The use patterns are coded as follows: A = Terrestrial, Pood Crop; B = Terrestrial, Nonfood; C = Aquatic,
Pood Crop; D = Aquatic, Nonfood; E = Greenhouse, Pood Crop; P = Greenhouse, Nonfood; G - Forestry; H = Domestic
Outdoor; I = Indoor.
37 Data must be submitted within the indicated timeframe, based on the date of the Guidance Document.
0 6 Month Due Date is April 30, 1986 .
0 9 Month Due Date is July 31/1986 .
0 15 Month Due Date is January 31, 198? .
V These studies must be performed with histopathologic examinations of the visual system and pituitary.
5/ The rat acute dermal study referenced in the "Material Information Bulletin" for methylthioacetate received from
Chevron Chemical Company must be submitted.
6/ Report Socal No. 2207 (GS0042049) is an interim report; the final report must be submitted.
]_/ The available rat acute inhalation study is classified as core minimum. An additional study must be performed
with histopathologic examinations of the visual system and pituitary.
8/ If blindness an/or lesions of the visual system or pituitary are observed in the acute oral studies (81-1), then
90-day feeding studies will be required. If required, the Agency will notify the registrant and will provide a
time frame for submittal of the data which will be 15 months from date of notification.
£/ A no-observed effect level (NOEL) for blindness and related histopathologic lesions must be defined.
10/ If blindness and/or lesions of the visual system or pituitary are observed in the acute inhalation study required
to be submitted, then a 90-day inhalation study will be required. If required, the Agency will notify the
registrant and will provide a time frame for submittal of the data which will be 15 months from date of notification.
ll/ A proposed protocol for these studies must be submitted within 6 months. The studies must be submitted within
12 months from date of acceptance of the protocol by the Agency.
12/ A mouse lymphoma mutagenicity screen test conducted on MTA has been received and is acceptable. Additional testing
as specified in the 84-2 data guidelines are required.
69
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II. REQUIREMENT FOR SUBMISSION OP GENERIC DATA
A. This portion of the guidance document Is a Notice
issued under the authority of PIPRA sec. 3(c)(2)(B). The
tables following this section list the data required for
maintaining the registrability of each product.
EPA has determined that additional generic data described
in Table A must be submitted to EPA for evaluation in order
to maintain in effect the registration(s) of your product(s)
identified as an attachment to the cover letter accompanying
this guidance document. As required by PIPRA sec. 3(c)(2)(B),
you are required to take appropriate steps to comply with
this Notice.
EPA may suspend the registration of each of those products
unless, within the specified time, you have informed EPA how
you will satisfy the requirements of this Notice. Any such
suspension will remain in effect until you have complied with
the terms of this Notice.
B. What Generic Datal/ Must be Submitted. You may deter-
mine which generic data you must submit by consulting Table A
at the end of this chapter. That table lists the generic
data needed to evaluate the continued registrability of all
products, and the dates by which the data must be submitted.
The required studies must be conducted in accordance with
EPA approved protocols (such as those contained in the Pesticide
Assessment Guidelines £/ or data collected under the approved
protocols of the Organization for Economic Cooperation and
Development (OECD). If you do not wish to develop data
in support of certain uses appearing in your labeling, you
may delete those uses at the time you submit your revised
labeling.
For certain kinds of testing (generally ecological
effects), EPA requires the test substance to be a "typical
formulation," and in those cases EPA needs data of that type
I/ Generic data pertain to the properties or effects of a
particular ingredient, and thus are relevant to an evaluation of
the risks of all products containing that ingredient, regardless
of the product's unique composition or specific use. Product-
specific data relate only to the properties or effects of a
product with a particular composition (or a group of products
with closely similar composition).
2/ The Pesticide Assessment Guidelines are available in hard
copy or microfiche from the National Technical Information
Service, 5285 Port Royal Road, Springfield, Va. 22161.
70
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for each major formulation category (e.g., emulsifiable concen-
trates, wettable powders, granulars, etc.) These are classified
as generic data and when needed are specified in Table A.
EPA may possess data on certain "typical formulations" but
not others. Note; "Typical formulation" data should not be
confused with product-specific data (Table B) which are
required on each formulation. Product-specific data are
further explained in Chapter III of this document.
C. Options Available for Complying With Requirements
to Submit Data
Within 90 days of your receipt of this Notice you must
submit to EPA a completed copy of the form entitled "PIPRA
Section 3(c)(2)(B) Summary Sheet" [EPA Form 8580-1, Appendix
II-3] for each of your products. On that form you must state
which of the following methods you will use to comply with
the requirements of this Notice:
1. (a) Notify EPA that you will submit the data, and
(b) either submit the existing data you believe will
satisfy the requirement, or state that you will generate
the data by conducting testing. If the test procedures
you will use deviate from (or are not specified in) the
Pesticide Assessment Guidelines or protocols contained in
the Reports of Expert Groups to the Chemicals Group,
Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must enclose the
protocols you will use.
OR
2. Notify EPA that you have entered into an agreement
with one or more other registrants to jointly develop (or
share in the cost of developing) the data. If you elect
this option, you must notify EPA which registrant(s) are
parties to the agreement.
OR
3. Pile with EPA a completed "Certification of Attempt to
Enter Into an Agreement With Other Registrants for Develop-
ment of Data" (EPA Form 8580-6, Appendix II-4)*/
*/ FIPRA sec. 3(c)(2)(B) authorizes joint development of
data Fy two or more registrants, and provides a mechanism by
which parties can obtain an arbitrator's decision if they agree
to jointly develop data but fail to agree on all the terms of
the agreement. The statute does not compel any registrant to
agree to develop data jointly.
(Footnote continued on next page)
71
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OR
4. Request that EPA amend your registration by deleting
the uses for which the data are needed. (This option is
not available to applicants for new products.)
OR
5. Request voluntary cancellation of the registration(s)
of your products for which the data are needed. (This option
is not available to applicants for new products.)
D. Procedures for Requesting Changes in Testing Methodology
and Extensions OJE1 Time
EPA recognizes that you may disagree with our conclusions
regarding the appropriate ways to develop the required data
or how quickly the data must be submitted. If the test
procedures you plan to use deviate from (or are not specified
in) the registration guidelines or protocols contained in
the reports of the Expert Groups to the Chemical Groups,
Organization for Economic Cooperation and Development (OECD)
Chemicals Testing Programme, you must submit the protocol
for Agency review prior to the initiation of the test.
If you think that you will need more time to generate the
required data than is allowed by EPA's schedule, you may
submit a request for an extension of time. The extension
request must be submitted in writing to the Product Manager.
(Footnote continued from previous page)
In EPA's opinion, joint data development by all regis-
trants subject to a data requirement or a cost-sharing agreement
among all such registrants is clearly in the public Interest.
Duplication of testing could increase costs, tie up testing
facilities, and subject an unnecessarily large number of
animals to testing.
As noted earlier, EPA has discretion to suspend the
registration of a product when a registrant fails to submit data
required under FIFRA Section 3(0)(2)(B). EPA has concluded that
it should encourage joint testing rather than duplicative
testing, and that suspension should be withheld in certain cases.
to further this goal. Accordingly, if (1) a registrant has
informed us of his intent to develop and submit data required
by this Notice; and (2) a second registrant informs EPA that
it has made a bona fide offer to the first registrant to share
in the expenses of the testing [on terms to be agreed upon
or determined by arbitration under PIFRA Section 3(c)(2)(B)(ill)];
and (3) the first registrant has declined to agree to enter
into a cost-sharing agreement, EPA will not suspend the
second firm's registration.
72
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The extension request should state the reasons why you believe
that an extension is appropriate. While EPA considers your
request, you must strive to meet the deadline for submitting
the required data.
III. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Note: Unless stated otherwise in Section I, Regulatory
Position and Rationale, this Section applies only to manufac-
turing use products, not to end use products.
A necessary first step in determining which statements
must appear on your product's label is the completion and
submission to EPA of product-specific data* listed on the
form entitled "Product Specific Data Report" (EPA Form
8580-4, Appendix III-l) to fill gaps identified by EPA
concerning your product. Under the authority of PIPRA sec.
3(c)(2)(B), EPA has determined that you must submit these
data to EPA in order to reregister your product(s). All of
these data must be submitted not later than six months after
you receive this guidance document.
Table B—Product-Specific Data Requirements for Manufacturing
Use Products — lists the product specific data you must submit.
Data that are required to be submitted are identified in the
column of those tables entitled "Must Data By Submitted
Under §3(c)(2)(B)."
IV. SUBMISSION OF REVISED LABELING
Note: This section applies to end use products only to the
extent described in Section I (Regulatory Position and
Rationale). Otherwise, the following information pertains
exclusively to manufacturing use products.
PIPRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the results of data concerning the product and its ingredients.
Labeling requirements are set out in 40 CPR 162.10 (see
Appendix IV-1) and are summarized for products containing
this active ingredient as part of this Guidance Document
(See Appendix IV-2). Applications submitted in response to
this notice must include draft labeling for Agency review.
V Product specific data pertain to data that support the
formulation which is marketed; it usually includes product
chemistry data and acute toxicity data.
73
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If you fail to submit revised labeling information
complying with this section (supplemented by requirements
described in Section I, Regulatory Position and Rationale),
EPA may issue a notice of intent to cancel the registration
under PIPRA sec. 6(b)(l).
A. 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 Appendix IV-2 .
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. See Appendix IV-1. [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. See Appendix IV-1.
[40 CFR 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.
See Appendix IV-1. [40 CPR I62.10(f)j
74
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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. See Appendix IV-1. [40 CPR
I62.10(g)]
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
on Front Panel
in Square Inches
5 and under
above 5 to 10
above 10 to 15
above 15 to 30
over 30
Signal Word
Minimum Type Size
All Capitals
6 point
10 point
12 point
14 point
18 point
"Keep Out of Reach
of Children"
Minimum Type Size
6 point
6 point
8 point
10 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. See Appendix IV-1.
[40 CFR I62.10(h)(l)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. See Appendix IV-1.
[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. See Appendix IV-1. [40 CFR 162,10(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. See Appendix IV-1. [40 CFR 162.10(h)(1)(ill)]
75
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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.
See Appendix IV- 1. [40 CPR 162 ,10(h) (1) ( ill) ]
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. See Appendix IV- 1. [40 CPR 162.10
Item 8 A. 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. See Appendix IV- 1. [40 CPR 162.10
Item 88. 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. See Appendix IV- 1. [40 CFR
l62.10(h)(2)(ii)J
Item 8C. PHYSICAL OR CHEMICAL HAZARD
1. Plammabllity statement. Precautionary statements relating
to f laramability of a product are required to appear on the
label if it meets the criteria in Appendix IV-3. The require-
ment 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.
2 . Criteria for declaration of non-f lammability . The
following criteria will be used to determine if a product
is non-flammable:
a. A "non-flammable gas" is a gas (or mixture of gases)
that will not ignite when a lighted match is placed
against the open cylinder valve.
b. A "non-flammable liquid" is one having a flashpoint
greater than 350°P (177°C).
76
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c. A "non-flammable aerosol" is one which meets the
following criteria:
i. The flame extension is zero inches;
ii. There is no flashback; and
ili. The flashpoint of the non-volatile liquid
component is greater than 350°F (177°C).
3. Declaration of non-flammability. Products which
meet the criteria for non-flammability specified
above may bear the notation "non-flammable" or "non-
flammable (gas, liquid, etc.)" on the label. It may
appear as a substatement to the ingredients statement,
or on a back or side panel, but shall not be highlighted
or emphasized (as with an inordinately large type
size) in any way that may detract from precaution.
4. Other physical/chemical hazard statements. When
chemistry data demonstrate hazards of a physical or
chemical nature other than flamraability, appropriate
statements of hazard will be prescribed. Such statements
may address hazards of explosivity, oxidizing or reducing
capability, or mixing with other substances to produce
toxic fumes.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA 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 I
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 40 CFR I62.11(c). You will be notified of
the Agency's classification decision.
77
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Classification Labeling Requirements
If Section I of this Guidance Document indicates that
your product has been classified for restricted use, the
following label requirements apply:
1. Front panel statement of restricted use classification.
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 162.10(h)(1)(iv)
b. Directly below this statement on the front panel,
a summary statement of the terras 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.
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Item 9B [There is no Item 9B].
Item 90. 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.
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 [There is no Item 10B].
Item IOC. 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
IV-4 to determine the disposal instructions appropriate for
your products.
Item 10D. 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. See
Appendix IV-1. [40 CFR 162.10]
B. 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.
79
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V. INSTRUCTIONS FOR SUBMISSION
A. For Manufacturing Products (MP) containing (name of
pesticide) as an active ingredient.
1. Within 90 days from receipt of this document, you must
submit to the Product Manager in the Registration Division at
the address given at the end of this section the "PIPRA Section
3(c)(2)(B) Summary Sheet" EPA Form 8580-1. Refer to Appendix
II-3 with appropriate attachments.
If on the Summary Sheet, you commit to develop the data,
request a minor chemical exemption, present arguments that a
data requirement is not applicable, or submit protocols or modified
protocols for Agency review, you must also 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 information 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.)
2. Within 6 months from receipt of this document you must
submit to the Product Manager on the Registration Division:
a. Confidential Statement of Formula, EPA Form 8570-4.
b. Product Specific Data Report, EPA Form 8580-4
(Appendix III-l).
c. Two copies of any required product-specific data.
d. Two copies of draft labeling, including the label and
associated brochures. If current labeling conforms to the
requirements of this guidance document and the results of
the short-term data, you may submit such labeling. End use
product labeling must comply specifically with the instructions
in Section I (Regulatory Position and Rationale) of this
guidance document. The 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 inch files. The draft
label must indicate the intended colors of the final label,
clear indication of the front panel label, and the intended
type sizes of the text.
e. Evidence of compliance with data support requirements
of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR 152.80-152.99
for latest requirements.
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 an^
test is delayed or aborted so that the agreed schedule cannot be
met, notify the Product Manager and the Office of Compliance
Monitoring.
80
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B. For Manufacturing Use Products containing diflubenzuron
in combination with other active ingredients
1. Within 90 days from receipt of this document, you must
submit the "FIFRA Section 3(c)(2)(B) Summary Sheet," EPA Form
8580-1. Refer to Appendix II-3 with appropriate attachments.
If on the Summary Sheet, you commit to develop the data,
request a minor chemical exemption, present arguments that a data
requirement is not applicable, or submit protocols or modified
protocols for Agency review, you must also 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 information 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.)
2. 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 agreed schedule cannot be
met, notify the Product Manager and the Office of Compliance
Monitoring.
C. For End Use Products containing dlflubenzuron alone
or in combination with other active ingredients:
1. Within 90 days from receipt of this document, you must
submit the "PIPRA Section 3(c)(2)(B) Summary Sheet," EPA Form
8580-1. Refer to Appendix II-3 with appropriate attachments.
If on the Summary Sheet, you commit to develop the data,
request a minor chemical exemption, present arguments that a
data requirement is not applicable, or submit protocols or modified
protocols for Agency review, you must also 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 Information 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.)
2. Within 6 months from receipt of this document .you must
submit:
a. Confidential Statement of Formula, EPA Form 8570-4.
b. Product-Specific Data Report, EPA Form 8580-4
(Appendix III-l) .
c. Two copies of any required product-specific data.
(Refer to Table C).
81
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d. Two copies of draft labeling, including the label and
associated brochures. If current labeling conforms to the
requirements of this guidance document and the results of
the short-term data, you may submit such labeling. End use
product labeling must comply specifically with the instructions
in Section I (Regulatory Position and Rationale) of this
guidance document. 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 inch files. The draft label
must indicate the intended colors of the final label, clear
indication of the front panel label, and the intended type
sizes of the text.
e. Evidence of compliance with data support requirements
of PIPRA sec. 3(c)(l)(D). Refer to 40 CPR 152.80-152.99
for latest requirements.
3. Within the time frames set forth in Table A, submit all
generic data, unless you are eligible for the f emulator's
exemption.
D. For intrastate products containing diflubenzuron
either as the sole active ingredient or in combination
with other active ingredients
These products are being called in for full Federal
registration. Producers of these products are being sent
a letter instructing them how to submit an application for
registration.
E. Applications and other required information should be
submitted to the following address:
William H. Miller
Product Manager (16)
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., SW.
Washington, B.C. 20460
Phone No. (703) 557-2600
The address for submission 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
82
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Appendix II-l
Guide to Use of 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
in 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 OP 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.
83
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Appendix II-l (continued)
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 27th, 123456-AA.
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Acephate Standard
MRID CITATION
00014219 Warnock, R.E. (1973) Metabolism of Orthene to Ortho 9006 Detected
in Rats. (Unpublished study received Feb 17, 1977 under 6F1680;
submitted by Chevron Chemical Co., Richmond, Calif.; CDL:
098473-C)
00014496 Tucker, B.V. (1972) Residues of Orthene and Ortho 9006 in a Marine
Diatom Growing in Treated Water. (Unpublished study received
Aug 7, 1972 under 239-2406; submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:001571-U)
00014518 Cheng, H.M. (1974) Characterization of 14C in Liver and Urine from
Rats Treated Orally with S-Methyl-14C-Orthene or S-Methyl-14C-
Ortho 9006. (Unpublished study received Nov 10, 1976 under 239-
2418; submitted by Chevron Chemical Co., Richmond, Calif.; CDL:
095570-L)
00014532 Rich, G.J.; Leary, J.B. (1975) Residue Data Sheet: Soybeans: Test
No. T-3074. (Unpublished study including test nos. T-3075 and
T-3197, received Sep 10, 1975 under 239-2418; submitted by Chev-
ron Chemical Co., Richmond, Calif.; CDL:195034-B)
00014533 Post, H.A.; Leary, J.B. (1975) Residue Data Sheet: Soybeans: Test
No. T-3076. (Unpublished study received Sep 10, 1975 under
239-2418; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:195034-C)
00014534 Moherek, E.A.; Leary, J.B. (1975) Residue Data Sheet: Soybeans:
Test No. T-3166. (Unpublished study received Sep 10, 1975 under
239-2418; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:195034-D)
00014540 Sakamoto, S.S.; Slagowski, J.L. (1976) Residue Data Sheet: Beans:
Test No. T-3682. (Unpublished study including test nos. T-3683
and T-3756, received Jun 7, 1977 under 239-2418; submitted by
Chevron Chemical Co., Richmond, Calif.; CDL.-232596-H)
00014541 Ross, B.L.; Slagowski, J.L. (1976) Residue Data Sheet: Snapbeans:
Test No. T-3743. (Unpublished study including test nos. T-3744,
T-3780, T-3781..., received Jun 7, 1977 under 239-2418; sub-
mitted by Chevron Chemical Co., Richmond, Calif.; CDL:232596-J)
00014555 Tucker, B.V. (1974) Characterization of 14C in Tissues and Milk
from Goats Fed S-Methyl-14C-Orthene or S-Methyl-14C-Ortho 9006.
(Unpublished study including test no. T-3201, received Nov 10,
1976 under 239-2418; submitted by Chevron Chemical Co., Rich-
mond, Calif.; CDL:095572-K)
85
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Acephate Standard
MRID CITATION
00014579 Chevron Chemical Company (1974) Orthene—and the Metabolite—Ortho
9006 Residue Analysis by Thermionic Gas Chromatography. Method
RM-12A-4 dated Apr 25, 1974. (Unpublished study received Sep
21, 1976 under 239-2418; CDL:095287-E)
00014635 O'Connor, T.F.; Galletta, T.A. (1975) Environmental Impact Study of
Aerially Applied Orthene on a Forest and Aquatic Ecosystem:
LOTEL Report 174. (Unpublished study received Jun 30, 1975 un-
der 239-2443; prepared by State Univ. of New York—Oswego, Lake
Ontario Environmental Laboratory, submitted by Chevron Chemical
Co., Richmond, Calif.; CDL.-225768-A)
00014637 Bocsor, J.G.; O'Connor, T.F. (1975) Environmental Impact Study of
Aerially Applied Orthene on a Forest and Aquatic Ecosystem: Im-
pact on Aquatic Ecosystem: LOTEL Report 174. (Unpublished study
received Jun 30, 1975 under 239-2443; prepared by State Univ.
of New York—Oswego, Lake Ontario Environmental Laboratory, sub-
mitted by Chevron Chemical Co., Richmond, Calif.; CDL:225768-C)
00014638 Devine, J.M. (1975) Environmental Impact Study of Aerially Applied
Orthene on a Forest and Aquatic Ecosystem: Persistence of Or-
thene Residues in the Forest and Aquatic Environment: LOTEL Re-
port 174. (Unpublished study received Jun 30, 1975 under 239-
2443; prepared by State Univ. of New York—Oswego, Lake Ontario
Environmental Laboratory, submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:225768-D)
00014639 Bart, J.; Streckewald, T.; Peakall, D. (1975) Environmental Impact
Study of Aerially Applied Orthene on a Forest and Aquatic Eco-
system: Impact on Birds: LOTEL Report 174. (Unpublished study
received Jun 30, 1975 under 239-2443; prepared by State Univ.
of New York—Oswego, Lake Ontario Environmental Laboratory, sub-
mitted by Chevron Chemical Co., Richmond, Calif.; CDL:225768-E)
00014642 Moore, R.B. (1975) Environmental Impact Study of Aerially Applied
Orthene on a Forest and Aquatic Ecosystem: Effects of Orthene
on Soil Microorganisms: LOTEL Report 174. (Unpublished study
received Jun 30, 1975 under 239-2443; prepared by State Univ.
of New York—Oswego, Lake Ontario Environmental Laboratory, sub-
mitted by Chevron Chemical Co., Richmond, Calif.; CDL:225768-H)
00014659 Elliott, E.J.; Leary, J.B. (1978) Residue Analysis of Acephate and
Methamidophos in Crops, Soil, Water and Milk. Method RM-12A-5
dated Jan 25, 1978. (Unpublished study received Apr 17, 1979
under 239-2464; submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:238179-G)
86
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Acephate Standard
MRID CITATION
00014675 Cavalli, R.D. (1970) Acute Oral Toxicity of Ortho RE 12,420: SOCO
127/111:39. (Unpublished study received Jun 21, 1972 under
239-EX-61; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:223505-F)
00014681 Cavalli, R.D. (1970) Acute Dermal Toxicity of RE 12,420: SOCO
134/111:35. (Unpublished study received Jun 21, 1972 under
239-EX-61; submitted by Chevron Chemical Co,, Richmond, Calif.;
CDL:223505-L)
00014686 Narcisse, J.K.; Cavalli, R.D. (1971) Eye Irritation Potential of
Orthene Technical, Orthene 75S (CC-2153), and Orthene 75S
(CC-2152): SOCAL 273/VI:107. (Unpublished study received Jun
21, 1972 under 239-EX-61; submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:223505-Q)
00014695 Haley, S. (1971) Report to Chevron Chemical Company, Ortho Divi-
sion: Teratogenic Study with Orthene Technical in Albino Rats:
IBT No. B190. (Unpublished study received Jun 21, 1972 under
239-EX-61; prepared by Industrial Bio-Test Laboratories, Inc.,
submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:223505-Z)
00014699 Hartke, K. (1971) Twelve-Month Status Report to Chevron Chemical
Company, Ortho Division: Two-Year Chronic Oral Toxicity Study
with RE 12,420 in Beagle Dogs: IBT No. C8732. (Unpublished
study received Jun 21, 1972 under 239-EX-61; prepared by Indus-
trial Bio-Test Laboratories, Inc., submitted by Chevron Chemical
Co., Richmond, Calif.; CDL:223505-AD)
00014700 Mastalski, K.; Jenkins, D.H. (1970) Report to Chevron Chemical
Company, Ortho Division: Acute Oral Toxicity Study with RE
12,420 Technical in Mallard Ducks: IBT No. J9110. (Unpublished
study received Jun 21, 1972 under 239-EX-61; prepared by Indus-
trial Bio-Test Laboratories, Inc., submitted by Chevron Chemical
Co., Richmond, Calif.; CDL:223505-AE)
00014701 Mastalski, K.; Jenkins, D.H. (1970) Report to Chevron Chemical
Company, Ortho Division: Acute Oral Toxicity Study with RE
12,420 Technical in Ringneck Pheasants: IBT No. J9110. (Unpub-
lished study received Jun 21, 1972 under 239-EX-61; prepared by
Industrial Bio-Test Laboratories, Inc., submitted by Chevron
Chemical Co., Richmond, Calif.; CDL:223505-AF)
87
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Acephate Standard
MRID CITATION
00014705 Hutchinson, C. (1970) Bioassay Report: Acute Toxicity of RE-12420
to Three Species of Freshwater Fish. (Unpublished study re-
ceived Jun 21, 1972 under 239-EX-61; prepared by Bionomics,
Inc., submitted by Chevron Chemical Co., Richmond, Calif.; CDL:
223505-AJ)
00014711 Sleight, B.H., III (19??) Bioassay Report: Acute Toxicity of Or-
thene (R) (SX-257) to the Brown Shrimp (Penaeus aztecus).
(Unpublished study received Jun 21, 1972 under 239-EX-61; pre-
pared by Bionomics, Inc., submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:223505-AP)
00014713 Sleight, B.H., III (1970) Bioassay Report: Acute Toxicity of RE-
12420 to Atlantic Oyster Embryo (Crassostrea virginica).
(Unpublished study received Jun 21, 1972 under 239-EX-61; pre-
pared by Bionomics, Inc., submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:223505-AR)
00014714 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1971) Effect of
Pesticides on Apiculture: Project No. 1499. (Unpublished study
received Jun 21, 1972 under 239-EX-61; prepared by Univ. of
California—Riverside, Dept. of Entomology, Div. of Economic
Entomology, submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:223505-AS)
00014715 Sakamoto, S,S.; Johansen, C.A. (1971) Toxicity of Orthene to Honey
Bees (Apis mellifera); Alfalfa Leaf Cutter Bees (Megachile
rotundata); Alkali Bees (Nomia melanderi); Bumble Bees
(Bombus auricomus). (Unpublished study received Jun 21,
1972 under 239-EX-61; prepared in cooperation with Washington
State Univ., Entomology Dept., submitted by Chevron Chemical
Co., Richmond, Calif.; CDL:223505-AT)
00014729 Chevron Chemical Company (1972) Orthene—and the Metabolite—Ortho
9006 Residue Analysis by Thermionic Gas Chromatography. Method
RM-12A dated Sep 12, 1972. (Unpublished study received Mar 27,
1973 under 3F1375; CDL:093665-C)
00014760 Ansolabehere, M.J.; Leary, J.B. (1973) Residue Data Sheet: Bell
Pepper: Test No. T-2467. (Unpublished study including test no.
T-2484, received Dec 13, 1974 under 5F1578; submitted by Chevron
Chemical Co., Richmond, Calif.; CDL:094328-B)
88
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Acephate Standard
MRID CITATION
00014762 Winner, W.M.; Leary, J.B. (1973) Residue Data Sheet: Sweet Peppers:
Test No. T-2471. (Unpublished study received Dec 13, 1974 under
5F1578; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:094328-D)
00014763 Adair, H.M.; Leary, J.B. (1973) Residue Data Sheet: Bell Pepper:
Test No. T-2473. (Unpublished study received Dec 13, 1974 under
5F1578; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:094328-E)
00014764 Winner, W.M.; Leary, J.B. (1973) Residue Data Sheet: Bell Peppers:
Test No. T-2485. (Unpublished study received Dec 13, 1974 under
5F1578; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:094328-F)
00014765 Libby, J.; Leary, J.B. (1972) Residue Data Sheet: Peppers: Test
No. T-2370. (Unpublished study received Dec 13, 1974 under
5F1578; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:094328-G)
00014768 Moherek, E.A.; Leary, J.B. (1973) Residue Data Sheet: Celery: Test
No. T-2372. (Unpublished study received Dec 13, 1974 under
5F1578; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:094328-J)
00014769 Ansolabehere, M.J.; Leary, J.B. (1973) Residue Data Sheet: Celery:
Test No. T-2426. (Unpublished study including test no. 2428,
received Dec 13, 1974 under 5F1578; submitted by Chevron Chemi-
cal Co., Richmond, Calif.; CDL:094328-K)
00014770 Sakamoto, S.S.; Leary, J.B. (1973) Residue Data Sheet: Celery: Test
No. T-2427. (Unpublished study received Dec 13, 1974 under
5F1578; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:094328-L)
00014771 Moherek, E.A.; Leary, J.B. (1974) Residue Data Sheet: Celery: Test
No. T-2431. (Unpublished study including test nos. T-2429 and
T-2430, received Dec 13, 1974 under 5F1578; submitted by Chevron
Chemical Co., Richmond, Calif.; CDL:094328-M)
00014772 Winner, W.M.; Leary, J.B. (1973) Residue Data Sheet: Celery: Test
No. T-2433. (Unpublished study received Dec 13, 1974 under
5F1578; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:094328-N)
89
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Acephate Standard
MRID CITATION
00014773 Ansolabehere, M.J.; Leary, J.B. (1974) Residue Data Sheet: Celery:
Test No. T-2811. (Unpublished study including test no. T-3050,
received Dec 13, 1974 under 5F1578; submitted by Chevron Chemi-
cal Co., Richmond, Calif.; CDL:094328-0)
00014774 Ansolabehere, M.J.; Dewey, M.L. (1973) Residue Data Sheet: Lima
Beans: Test No. T-2439. (Unpublished study received Dec 13,
1974 under 5F1578; prepared in cooperation with Morse Laborato-
ries, Inc., submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:094328-Q)
00014775 Winner, W.M.; Leary, J.B. (1973) Residue Data Sheet: Lima Beans:
Test No. T-2443. (Unpublished study received Dec 13, 1974 under
5F1578; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:094328-R)
00014776 Moherek, E.A.; Leary, J.B. (1973) Residue Data Sheet: Lima Beans:
Test No. T-2445. (Unpublished study received Dec 13, 1974 under
5F1578; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:094328-S)
00014777 Sakamoto, S.S.; Leary, J.B. (1973) Residue Data Sheet: Lima Beans:
Test No. T-2481. (Unpublished study received Dec 13, 1974 under
5F1578; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:094328-T)
00014778 Kensler, D.L., Jr.; Dewey, M.L. (1974) Residue Data Sheet: Lima
Beans: Test No. T-2480. (Unpublished study received Dec 13,
1974 under 5F1578; prepared in cooperation with Morse Laborato-
ries, Inc., submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:094328-U)
00014780 Winner, W.M.; Leary, J.B. (1973) Residue Data Sheet: Green Snap
Beans: Test No. T-2444. (Unpublished study received Dec 13,
1974 under 5F1578; submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:094328-W)
00014781 Moherek, E.A.; Leary, J.B. (1973) Residue Data Sheet: Pole Beans:
Test No. T-2446. (Unpublished study received Dec 13, 1974 under
5F1578; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:094328-X)
00014782 Moherek, E.A.; Leary, J.B. (1973) Residue Data Sheet: Snap Beans:
Test No. T-2483. (Unpublished study received Dec 13, 1974 under
5F1578; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:094328-Y)
90
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Acephate Standard
MRID CITATION
00014783 Moherek, E.A.; Leary, J.B. (1973) Residue Data Sheet: Green Snap
Beans: Test No. T-2862. ^Unpublished study received Dec 13,
1974 under 5F1578; submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:094328-Z)
00014787 Sakamoto, S.S.; Leary, J.B. (1973) Residue Data Sheet: Dry Beans:
Test No. T-2830. {Unpublished study received Dec 13, 1974 under
5F1578; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:094328-AD)
00014791 Ansolabehere, M.J.; Leary, J.B. (1974) Residue Data Sheet: Beans:
Test No. T-2440. (Unpublished study received Dec 13, 1974 under
5F1578; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:094328-AH)
00014852 Rushing, K.W.; Leary, J.B. (1973) Residue Data Sheet: Cotton: Test
No. T-2706. (Unpublished study including test nos. T-2707 and
T-2708, received Mar 19, 1975 under 239-2434; submitted by Chev-
ron Chemical Co., Richmond, Calif.; CDL:222344-D)
00014853 Schaefer, R.E.; Leary, J.B. (1974) Residue Data Sheet: Cotton: Test
No. T-3009. (Unpublished study received Mar 19, 1975 under 239-
2434; submitted by Chevron Chemical Co., Richmond, Calif.; CDL:
222344-E)
00014854 Cummings, R.H.; Leary, J.B. (1974) Residue Data Sheet: Cotton: Test
No. T-3007. (Unpublished study received Mar 19, 1975 under 239-
2434; submitted by Chevron Chemical Co., Richmond, Calif.; CDL:
222344-G)
00014855 Rushing, K.W.; Leary, J.B. (1974) Residue Data Sheet: Cotton: Test
No. T-3006. (Unpublished study received Mar 19, 1975 under 239-
2434; submitted by Chevron Chemical Co., Richmond, Calif.; CDL:
222344-H)
00014860 Buckner, C.H.; McLeod, B.B. (1975) Impact of Aerial Applications of
Orthene (R) upon Non-Target Organisms: Report CC-X-104. (Un-
published study received Mar 23, 1977 under 239-2443; prepared
by Canada, Forestry Service, Chemical Control Research Insti-
tute, submitted by Chevron Chemical Co., Richmond, Calif.; CDL:
228753-C)
00014971 Thompson, J.P.; Crossley, J. (1971) Residue Data Sheet: Lettuce:
Test No. T-2051. (Unpublished study received Feb 23, 1972 under
2G1248; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:091774-D)
91
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Acephate Standard
MRID CITATION
00014983 Chevron Chemical Company (1972) Analysis of Orthene Residues by
Thin-Layer Chromatography. Method RM-12B dated Jan 21, 1972.
(Unpublished study received Feb 23, 1972 under 2G1248; CDL:
091774-Q)
00014986 Crossley, J. (1972) Hydrolysis of Orthene. (Unpublished study re-
ceived Feb 23, 1972 under 2G1248; submitted by Chevron Chemical
Co., Richmond, Calif.; CDL:091774-T)
00014987 Lee, H. (1972) Photodegradation of Orthene in Water. (Unpublished
study received Feb 23, 1972 under 2G1248; submitted by Chevron
Chemical Co., Richmond, Calif.; CDL:091774-U)
00014988 Tucker, B.V. (1972) Orthene Stability in Soil Leachate. (Unpub-
lished study received Feb 23, 1972 under 2G1248; submitted by
Chevron Chemical Co., Richmond, Calif.; CDL:091774-V)
00014989 Tucker, B.V. (1972) Plant Metabolism of S-Methyl-14C-Orthene. (Un-
published study received Feb 23, 1972 under 2G1248; submitted by
Chevron Chemical Co., Richmond, Calif.; CDL:091774-W)
00014990 Crossley, 0. (1972) Uptake and Translocation of Orthene by Plants.
(Unpublished study including test nos. T-2125 and T-2126, re-
ceived Feb 23, 1972 under 2G1248; submitted by Chevron Chemical
Co., Richmond, Calif.; CDL:091774-X)
00014991 Tucker, B.V. (1972) Orthene Soil Metabolism—Laboratory Studies.
(Unpublished study including supplement, received Feb 23, 1972
under 2G1248; submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:091774-Z)
00014992 Tucker, B.V. (1972) Orthene Leaching in Soil. (Unpublished study
including supplementary report, received Feb 23, 1972 under
2G1248; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:091774-AA)
00014992 Tucker, B.V. (1972) Orthene Leaching in Soil. (Unpublished study
including supplementary report, received Feb 23, 1972 under
2G1248; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:091774-AA)
00014994 Lee, H. (1972) Metabolism of Orthene in Rats. (Unpublished study
including letter dated Jan 6, 1972 from C.F. Ott to J.N. Ospen-
sen, received Feb 23, 1972 under 2G1248; submitted by Chevron
Chemical Co., Richmond, Calif.; CDL:091774-AC)
92
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Acephate Standard
MRID CITATION
00015038 Adair, H.M.; Leary, J.B. (1972) Residue Data Sheet: Cotton: Test
No. T-2069. {Unpublished study including test nos. T-2070,
T-2253, T-2254..., received Mar 27, 1973 under 3F1375; submitted
by Chevron Chemical Co., Richmond, Calif.; CDL:093666-0)
00015042 Lauck, J.E.; Leary, J.B.; Schinski, W.L. (1972) Residue Data Sheet:
Lettuce: Test No. T-2260. (Unpublished study received Mar 27,
1973 under 3F1375; submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:093666-U)
00015049 Adair, H.M.; Leary, J.B. (1972) Residue Data Sheet: Soybeans: Test
No. T-2088. (Unpublished study including test nos. T-2249 and
T-2250, received Mar 27, 1973 under 3F1375; submitted by Chevron
Chemical Co., Richmond, Calif.; CDL:093667-G)
00015050 Adair, H.M.; Leary, J.B.; Schinski, W. (1972) Residue Data Sheet:
Soybeans: Test No. T-2089. (Unpublished study received Mar 27,
1973 under 3F1375; submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:093667-H)
00015060 Adair, H.M.; Schinski, W.; Leary, J.B. (1972) Residue Data Sheet:
Soybeans: Test No. T-2090. (Unpublished study received Mar 27,
1973 under 3F1375; submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:093667-W)
00015122 Chevron Chemical Company (1973) Summary: Residue and Metabolism:
Orthene (Acephate): Tobacco. Summary of studies 001571-B,
001578-G through 001578-1, 091774-X, 091774-Z, 091774-AA,
223490-D, 223490-E, 223490-G through 223490-1, 223490-R,
223490-T, 223490-U, 223490-W, 223490-X and 223490-AE. (Unpub-
lished study received Jul 20, 1973 under 239-2419; CDL:001578-F)
00015125 Moherek, E.A.; Schinski, W. (1972) Residue Data Sheet: Flue-Cured
Tobacco: Test No. T-2300. (Unpublished study including test no.
T-2301, received Jul 20, 1973 under 239-2419; submitted by Chev-
ron Chemical Co., Richmond, Calif.; CDL:001578-I)
00015183 Ladd, R. (1972) Report to Chevron Chemical Company, Ortho Division,
Meat and Milk Residue Study with Orthene-Ortho 9006 (SX-434) in
Dairy Cattle: IBT No. J2042. (Unpublished study received Mar
27, 1973 under 3F1375; prepared by Industrial Bio-Test Labora-
tories, Inc., submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:093669-H)
93
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Acephate Standard
MRID CITATION
00015187 Tucker, B.V. (1974) Terminal Residues in Alfalfa and Radishes
Treated with S-Methyl-14C-Orthene. (Unpublished study received
on unknown date under 3F1375; submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:093676-B)
00015188 Tucker, B.V.; Pack, D.E. (1974) Analysis of Orthene Treated Field
Crops for Bound Orthene or Ortho 9006 Residues. (Unpublished
study received on unknown date under 3F1375; submitted by
Chevron Chemical Co., Richmond, Calif.; CDL:093676-C)
00015190 Ansolabehere, M.J.; Leary, J.B. (1973) Residue Data Sheet: Crisp
Head Lettuce: Test No. T-2546. (Unpublished study including
test nos. T-2743, T-2745, T-2746..., received Oct 11, 1973 under
3F1375; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:093676-I)
00015191 Sakamoto, S.S.; Leary, J.B. (1973) Residue Data Sheet: Crisphead
Lettuce: Test No. T-2749. (Unpublished study including test
nos. T-2750 and T-2794, received Oct 11, 1973 under 3F1375; sub-
mitted by Chevron Chemical Co., Richmond, Calif.; CDL:093676-J)
00015192 Sakamoto, S.S.; Leary, J.B. (1974) Residue Data Sheet: Crisphead
Lettuce: Test No. T-2751. (Unpublished study including test
nos. T-2760 and T-2889, received on unknown date under 3F1375;
submitted by Chevron Chemical Co., Richmond, Calif.; CDL:
093676-K)
00015193 Sakamoto, S.S.; Ansolabehere, M.J.; Leary, J.B. (1974) Residue Data
Sheet: Crisphead Lettuce: Test No. T-2753. (Unpublished study
including test no. T-2754, received on unknown date under
3F1375; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:093676-L)
00015194 Ansolabehere, M.J.; Leary, J.B. (1974) Residue Data Sheet: Crisp-
head Lettuce: Test No. T-2755. (Unpublished study including
test nos. T-2756, T-2757, T-2758..., received on unknown date
under 3F1375; submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:093676-M)
00015196 Ansolabehere, M.J.; Leary, J.B. (1973) Residue Data Sheet: Cotton:
Test No. T-2256. (Unpublished study received Oct 11, 1973 under
3F1375; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:093676-P)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Acephate Standard
MRID CITATION
00015198 Adair, H.M.; Kalens, K.J.; Leary, J.B. (1974) Residue Data Sheet:
Cotton: Test No. T-2532. (Unpublished study received on unknown
date under 3F1375; prepared in cooperation with Pattison's Labo-
ratories, Inc., submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:093676-R)
00015199 Slocum, J.B.; Kalens, K.J.; Leary, J.B. (1974) Residue Data Sheet:
Cotton: Test No. T-2533. (Unpublished study including test no.
T-2534, received on unknown date under 3F1375; prepared in coop-
eration with Pattison's Laboratories, Inc., submitted by Chevron
Chemical Co., Richmond, Calif.; CDL:093676-S)
00015202 Tucker, B.V. (1972) Stability of Orthene to Sunlight. (Unpublished
study received Mar 27, 1973 under 239-EX-60; submitted by Chev-
ron Chemical Co., Richmond, Calif.; CDL:223490-E)
00015203 Tucker, B.V. (1973) Total 14C Accountability of S-Methyl-14C-Or-
thene Applied to Bean Seedlings. (Unpublished study received
Mar 27, 1973 under 239-EX-60; submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:223490-G)
00015206 Sakamoto, S.S.; Tucker, B.V.; Leary, J.B. (1972) Residue Data
Sheet: Cotton: Test No. T-2071. (Unpublished study received Mar
27, 1973 under 239-EX-60; submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL.-223490-L)
00015209 Tucker, B.V. (1972) Comparison of Acephate Soil Leaching and Sta-
bility in Wet and Dry Soil. (Unpublished study received Mar 27,
1973 under 239-EX-60; submitted by Chevron Chemical Co., Rich-
mond, Calif.; CDL:223490-S)
00015210 Warnock, R.E. (1973) 14C-Orthene Residues in Soil and Uptake by
Carrots—EPA Protocol. (Unpublished study received Mar 27, 1973
under 239-EX-60; submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:223490-T)
00015212 Warnock, R.E. (1972) Orthene Leaching Study—EPA Protocol. (Unpub-
lished study received Mar 27, 1973 under 239-EX-60; submitted by
Chevron Chemical Co., Richmond, Calif.; CDL:223490-X)
00015213 Tucker, B.V. (1972) Leachability of Orthene Residues in Soil 150
Days after Orthene Treatment—Greenhouse Test. (Unpublished
study received Mar 27, 1973 under 239-EX-60; submitted by Chev-
ron Chemical Co., Richmond, Calif.; CDL:223490-Y)
95
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Acephate Standard
MR ID CITATION
00015307 Rittenhouse, J.R.; Wong, Z.A. (1979) The Acute Inhalation Toxicity
of Orthene Specialty Concentrate: SOCAL 1420/36:104. (Unpub-
lished study received Oct 31, 1979 under 239-EX-92; submitted by
Chevron Chemical Co., Richmond, Calif.; CDL:241253-G)
00015323 Henarick, L.E.; Slagowski, J.L. (1978) Residue Data Sheet: Celery:
Test No. T-3935. (Unpublished study received Nov 13, 1979 under
239-2418; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL.-241337-C)
00015324 Sakamoto, S.S.; Slagowski, J.L. (1978) Residue Data Sheet: Celery:
Test No. T-4203. (Unpublished study received Nov .13, 1979 under
239-2418; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:241337-D)
00015325 Hendrick, L.E.; Slagowski, J.L. (1977) Residue Data Sheet: Celery:
Test No. T-4212. (Unpublished study received Nov 13, 1979 under
239-2418; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:241337-E)
00015326 Carter, E.A.; Slagowski, J.L. (1978) Residue Data Sheet: Celery:
Test No. T-4321. (Unpublished study received Nov 13, 1979 under
239-2418; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:241337-F)
00015327 Sakamoto, S.S.; Soderquist, C.J. (1979) Residue Data Sheet: Celery:
Test No. T-4462. (Unpublished study received Nov 13, 1979 under
239-2418; prepared in cooperation with California Analytical
Laboratories, submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:241337-G)
00015328 Kirby, B.W.; Dewey, M.L. (1979) Residue Data Sheet: Celery: Test
No. T-4494. (Unpublished study received Nov 13, 1979 under 239-
2418; prepared in cooperation with Morse Laboratories, Inc.,
submitted by Chevron Chemical Co., Richmond, Calif.; CDL:
241337-H)
00015329 Johnson, R.R.; Soderquist, C.J. (1979) Residue Data Sheet: Celery:
Test No. T-4582. (Unpublished study received Nov 13, 1979 under
239-2418; prepared in cooperation with California Analytical
Laboratories, submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:241337-I)
96
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Acephate Standard
MRID
CITATION
00015956 Fletcher, D. (1976) Report to Chevron Chemical Company: 8-Day
Dietary LC50 Study with Orthene Technical in Bobwhite Quail:
IBT No. 8580-09326. (Unpublished study received Mar 23, 1977
under 239-2443; prepared by Industrial Bio-Test Laboratories,
Inc., submitted by Chevron Chemical Co., Richmond, Calif.; CDL:
228753-A)
00015957 Fletcher, D. (1976) Report to Chevron Chemical Company: 8-Day
Dietary LC50 Study with Orthene Technical in Mallard Duck-
lings: IBT No. 8580-09327. (Unpublished study received Mar 23,
1977 under 239-2443; prepared by Industrial Bio-Test Labora-
tories, Inc., submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:228753-B)
00015962 Hudson, R.H. (1972) Orthene Data: Acute Oral: Mallards. (Internal
Report Series in Pharmacology; unpublished study received Mar
27, 1973 under 3F1375; prepared by U.S. Fish and Wildlife Ser-
vice, Denver Wildlife Research Center, Section of Pesticide-
Wildlife Ecology, Unit of Physiological and Pharmacological
Studies, submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:093671-F)
00028625 Simmon, V.F. (1979) In vitro Microbiological Mutagenicity and Un-
scheduled DNA Synthesis Studies of Eighteen Pesticides: Report
No. EPA-600/1-79-041. (Unpublished study including submitter
summary, received Apr 3, 1980 under 279-2712; prepared by SRI
International, submitted by FMC Corp., Philadelphia, Pa.; CDL:
099350-A)
00029683 Berry, R.E.; Leary, J.B.; Byrne, H.D.; et al. (1977) Orthene 75
Soluble—Mint: Residue Chemistry Data: Summary. (Unpublished
study received Feb 11, 1980 under OE2323; prepared in coopera-
tion with Oregon State Univ., Dept. of Entomology and others,
submitted by Interregional Research Project No. 4, New Bruns-
wick, N.J.; CDL:099240-A)
00029691 Beavers, J.B., Fink, R.; Grimes, J.; et al. (1979) Final Report:
One-Generation Reproduction Study—Mallard Duck: Project
No. 162-107. Includes method
study including letters dated
Francis X. Kamienski; Jan 12,
Leary; Jan 15, 1979 from J.B.
Mar 1, 1979 from J.B. Beavers to Francis
Feb 21, 1980 under 239-2418; prepared by
Ltd., submitted by Chevron Chemical Co.,
241824-C)
dated Aug 28, 1978. (Unpublished
Dec 11, 1978 from J.B. Beavers to
1979 from F.X. Kamienski to J.B.
Beavers to Francis X. Kamienski;
X. Kamienski, received
Wildlife International,
Richmond, Calif.; CDL:
97
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OFFICE OP PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Acephate Standard
MRID CITATION
00029692 Beavers, J.B.; Pink, R.; Grimes, J.; et al. (1979) Final Report:
One-Generation Reproduction Study—Bobwhite Quail: Project
No. 162-106. Includes method dated Aug 28, 1978. (Unpublished
study including letters dated Dec 11, 1978 from J.B. Beavers to
Francis X. Kamienski; Jan 12, 1979 from P.X. Kamienskl to J.B.
Leary; Jan 15, 1979 from J.B. Beavers to Francis X. Kamienski;
Mar 1, 1979 from J.B. Beavers to Francis X. Kamienski; Apr 2,
1979 from J.B. Beavers to F.X. Kamienski, received Feb 21, 1980
under 239-2418; prepared by Wildlife International, Ltd., sub-
mitted by Chevron Chemical Co., Richmond, Calif.; CDL:24l824-D)
00029696 Rittenhouse, J.R. (1979) S-1458: The Acute Oral Toxlcity of Orthene
Specialty Concentrate: SOCAL 1416/37:80. (Unpublished study re-
ceived Mar 11, 1980 under 239-EX-95; submitted by Chevron Chemi-
cal Co., Richmond, Calif.; CDL:242078-C)
00029738 Pieper, G.R.; Roberts, R.B.; Larson, J.E. (1977) Residue Analysis
of Carbaryl, Diflubenzuron and Acephate in Foliage, Duff, Water,
Soil, Sediment and Bee Pollen. Final rept. (Unpublished study
received Jul 31, 1978 under 148-1259; prepared in cooperation
with Pacific Southwest Forest and Range Experiment Station, sub-
mitted by Thompson-Hayward Chemical Co., Kansas City, Kans.;
CDL:234514-D)
05007862 Bull, D. (1979) Fate and efficacy of acephate after application
to plants and insects. Journal of Agricultural and Food
Chemistry 27(2):268-272.
05012201 Rabeni, C.; Stanley, J. (1979) Operational spraying of acephate
to suppress spruce budworm has minor effects on stream fishes
and invertebrates. Bulletin of Environmental Contamination and
Toxicology 23(3):327-334.
05014159 Tappan, W.B.; Wheeler, W.B.; Lundy, H.W. (1974) Insect control and
chemical residues after applying acephate on cigar-wrapper and
flue-cured tobaccos in Florida, Journal of Economic Entomology
67(5):648-650.
05014922 Bart, J. (1979) Effects of acephate and Sevin on forest birds.
Journal of Wildlife Management 43(2):544-549.
05015409 Szeto, S.; MacCarthy, H.; Oloffs, P.; Shepherd, R. (1978)
Residues in douglas-fir needles and forest litter following
an aerial application of acephate (Orthene). Journal of
Environmental Science and Health, Part B 13(2):87-103-
05017571 Buckner, C; MacLeod, B. (1975) Impact of Aerial Applications of
Orthene Upon Non-Target Organisms: Information Report No.
CC-X-104. Ottawa, Ontario, Canada: Environment Canada,
Forestry Service, Chemical Control Research Institute.
98
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REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Acephate Standard
MRID CITATION
05018064 Szeto, S; MacCarthy, H.; Oloffs, P.; Shepherd, R. (1979) The
fate of acepnate and carbaryl in water. Journal of
Environmental Science and Health, Part B l4(6):635-654.
05018314 Schoettger, R.] Hauck, W. (1978) Toxicity of experimental forest
insecticides to fish and aquatic invertebrates. P 11-27
in Proceedings of the First and Second USE-UUR Symposia
on the Effects of Pollutants Upon Aquatic Ecosystems: Jun 22-
26, 1976, Borok, USSR. V01. II: USSR Symposium. Available from
National Technical Information Service PB-287 219. Washington,
D.C.: U.S. Environmental Protection Agency EPA-600/3-78-
706.
05019256 Buckner, C.; Mcleod, B.; Lidstone, R. (1976) Environmental
Impact Studies of Spruce Budworm (Choristoneura Pumiferana
Clemens) Control Programs in New Brunswick in 1976: Report
No. CC-X-135. Ottawa, Ontario, Canada: Environment Canada,
Forestry Service, Chemical Control Research Institute.
05021173 Buckner, C.; Mcleod, B. (1977) Impact of Experimental Spruce
Budworm (Choristoneura fumiferana Clemens) Suppression Trials
Upon Forest Dwelling Birds in Newfoundland in 1977: Report No.
FPM-X-9. Sault, Ste. Marie, Ontario, Canada: Department of
Fisheries and the Environment, Canadian Forestry Service,
Forest Pest Management Institute.
99
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Standard
GS0042001 Chevron Chemical Co. (1972) Orthene—and the metabolite—9006
Residue analysis by thermionic gas chromatography. Method
RM-12A-3 dated September 12, 1972. File No. 7401.01 in Section D
of PP# 6F1680. Unpublished study prepared by Chevron Chemical
Company, Richmond, CA. (Ace, No. 094614)
GS0042002 Chevron Chemical Co. (1972) The stability of Orthene residues in
frozen crops and extracts. Dated January 20, 1972. File No. 721.21.
Reference 15.1 in Section D (Vol. IV of V) of PP#3P1375 (Ace.
No. 118186).
GS0042003 Chevron Chemical Co. (1972) Orthene—stability of residues in
crops and crop extracts. Dated December 29, 1972. File
No. 741.11. X773.21. Reference 15.2 in Section D (Vol. IV of
V) of PP03F1375 (Ace. No. 118186).
GS0042004 Chevron Chemical Co. (1980) Orthene 75S Soluble Powder, EPA
Reg. No. 239-2418, 12-03 Residue Chemistry Data. Submitted
December 17, 1980 and received December 29, 1980 under 239-2418.
(Ace. No. 244042)
GS0042005 Chevron Chemical Co. (1982) Orthene 75S Soluble Powder, EPA Reg.
No. 239-2418, Residue Chemistry Data. Submitted June 30, 1982,
and received July 12, 1982, under 239-2418. (Ace. No. 247950).
GS0042006 Chevron Chemical Co. (1982) Orthene (acephate) Amendment to
pesticide petition 7F1899: Broccoli, brussels sprouts, cauliflower.
Section D. Test Nos. T-2077, T-2078, T-2079, T-2271, T-2272,
T-2274, T-2275, and T-3555. Submitted September 29, 1982, and
received October 7, 1982, under PP#7F1899 (Ace. No. 071165).
GS0042007 Chevron Chemical Co. (1982) Orthene (acephate) Amendment
to pesticide petition pp #7F1899: Broccoli, brussels sprouts,
cauliflower. Section D. Test Nos. T-2053, T-2054, T-2244, T-
2245, T-2597, T-2834, T-3818, and T-3819- Submitted September
29, 1982, and received October 7, 1982, under PP#7Fl899 (Ace.
No. 071165).
GS0042008 Chevron Chemical Co. (1981) Orthene 75S Soluble Powder, EPA
Reg. No. 239-2418, 12-03 Residue Chemistry Data. Submitted
March 25, 1981, and received March 31, 1981, under 239-2418 (Ace,
No. 244863).
GS0042009 Chevron Chemical Co. (1980) Section D, including test nos.
T-4539, T-4569, T-4734, T-4643, T-4644, T-4645, T-4925, T-5139,
and T-5167. Dated November 1980 and received November 25, 1980
under PP#1F2449 (Ace. No. 099765).
100
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Standard
GS0042010
GS0042011
GS0042012
GS0042013
GS0042014
GS0042015
GS0042016
GS0042017
GS0042018
IR-4 Project-Rutgers (1982) Section D. Test Nos. T-3534, T-
3538, T-3539, T-3665, T-4033, T-4034, T-4035, T-4036, T-4037, T-
T-5055, T-5056, T-5155, and T-5456.
and received October 13, 1982, under
4038, T-4046, T-4047, T-5006,
Submitted September 28, 1982,
PP#3E2770 (Ace. No. 071173).
Chevron Chemical Co. (1982) Section D including test nos. T-
3265, T-3266, T-3267, T-3268, T-3456, T-4291, T-4292, T-4293, T-
4295, T-4917, T-4918, T-5085, T-5086, T-5087, T-5088, and T-
5240. Submitted January 1982 and received January 19, 1982,
under PP#2F2632 (Ace. No. 070604).
Chevron Chemical Co. (1982) Tobacco Insect Spray, EPA Reg.
No. 239-2419, Residue Chemistry Data. Submitted June 16, 1982,
and received June 23, 1982, under 239-2419. (Ace. No. 247951).
Chevron Chemical Co. (1979) Section D including test nos.
T-4658, T-4659, T-4660, T-4661, T-4662, T-4663, and T-4670.
Submitted April 11, 1979 and received April 17, 1979, under
FAP#9H5216 (Ace. No. 238179).
Chevron Chemical Co. (1980) Amendment to Sections D, F, and G of
the acephate food additive petition 9H5216. Includes test nos.
T-5031 and T-5138. Submitted July 11, 1980, and received July
16, 1980, under FAP#9H52l6 (Ace. No. 242895).
Chevron Chemical Co., B.V. Tucker, File #741.11; January 11,
1973, a swine feeding study in PP#3F1375/FAP#4H5054.
(Ace. No. 118186).
Johnson, W.W.; Finley M.T. (1980) Handbook of acute toxicitj-
of chemicals to fish and aquatic invertebrates. United States
Department of the Interior Fish and Wildlife Service/Resource
Publication 137 Washington, DC.
McEwen, L.C.; DeWeese, L.R. Unpublished. Summary of 1981
Field studies of acephate effects on rangeland wildlife. U.S.
Fish and Wildlife Service, Patuxent Wildlife Research Center.
McEwen, L.C.; Deweese, L.R.; Laraont, T.; Kolbe, E. Unpublished.
Field studies of wildlife hazards related to new range grasshopper
control chemicals and other materials. Progress Report:
October 1, 1979 - September 30, 1980. U.S. Department of
Interior, Fish and Wildlife Service, Patuxent Wildlife Research
Center.
101
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Standard
GS0042019
GS0042020
GS0042021
GS0042022
GS0042023
GS0042024
GS0042025
GS0042026
GS0042027
Petersen, B.; Palmer, D.; Ryder, R. (1981) Unpublished.
The effects of acephate on rangeland wildlife. Colorado State
University, Fishery and Wildlife Biology Department, Fort Collins,
Colorado.
Richmond, M. L.; Henny, C.J.; Floyd, R.L.; Mannan, R.W.j
Finch, D.M.; DeWeese L.R. (1979) Effects of Sevin-4-Oil,
Dimilin, and Orthene on forest birds in Northeastern Oregon.
Res. Paper PSW-148, 19 p., illus. Pacific Southwest Forest and
Range Exp. Stn., Forest Service, U.S. Dep. Agric. Berkeley.
Calif.
Thompkins, J. (1978) Unpublished. Acephate: 48-hour
acute toxicity test (Daphnia magna). U.S.EPA, Benefits and
Field Studies Division, Agricultural Research Center, Beltsville,
MD.
Zinkl, J.G.; Roberts R.B.; Henney C.J.; Lenhart D.S. (1980)
Inhibition of brain cholinesterase of forest birds and squirrels
exposed to aerially applied acephate (Orthene®). Bull. Environ.
Contain. Toxlcol. 24, 676.
Chevron Chemical Co. (1977) The acute dermal toxicity of Orthene
Technical: SOCAL 1110/29:57 (EPA Ace. No. 242041).
Bio/dynamics, Inc. (1978) One-year Interim report of a lifetime
oral toxicity/carcinogeniclty study with Technical RE-12420 in
rats: Project No. 78-2135. Submitted by Chevron Chemical
Company. (EPA Ace. No. 241621).
Chevron Chemical Co.
study in beagle dogs:
No. 093671).
(1972) Two-year chronic oral toxicity
Final report: IBT No. 08732 (EPA Ace.
International Research and Development Corp. (1981) Interim
report of Technical (RE-12420) Orthene lifetime oral carcinogenicity
study In mice. Histopathology data: Project No. 415-006.
Submitted by Chevron Chemical Company (EPA Ace. No. 245374).
International Research and Development Corp. (1979) Lifetime
Oral Carcinogenicity study in mice (1-year interim report):
Project No. 415-006. Submitted by Chevron Chemical Company
(EPA Ace. No. 242275).
102
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Standard
GS0042028 International Research and Development Corp. (1980) Teratology
study in rabbits: Study No. 45-024. Submitted by Chevron
Chemical Company (EPA Ace. No. 245262).
GS0042029 International Research and Development Corp. "ORTHENE Technical
(RE-12420); Lifetime Oral Carcinogeniclty Study in Mice. No.
415-006; February 24, 1982, submitted by Chevron Chemical Company.
(EPA Ace. Nos. 247717-247719).
GS0042030 Bio/dynamics, Inc. (1978) A Subacute Dietary Range Finding
Study of Technical RE-12420 in mice. Project No. 77-1892.
Submitted by Chevron Chemical Company. (EPA Ace. No.
250484).
GS0042031 Acephate: Response from Chevron Chemical Company with regard to
the mouse oncogenic study entitled "ORTHENE Technical (RE-12420):
Lifetime Oral Carcinogenicity Study in Mice. No. 415-006;
February 24, 1982; (EPA Ace. No. 250666).
GS0042032 Bio/dynamics, Inc. (1981) Historical Data for the Lifetime Oral
Toxicity/Carcinogenicity Study with Technical RE-12420 in Rats.
Project No. 78-2135, submitted by Chevron Chemical Company.
(EPA Ace. No. 247508).
GS0042033 Bio/dynamics, Inc. A Lifetime Oral Toxicity/Carcinogenicity
Study with Technical RE-12420 (Acephate) in Rats; Project No. 78-
2135; June 30, 1981: Submitted by Chevron Chemical Co. (EPA
Ace. No. 245748 through 245756).
GS0042034 Life Service Research (1983) ORTHENE Technical: Chollnesterase
Inhibition and Cytogenetics in the monkey. Submitted by Chevron
Chemical Co. (EPA Ace. Nos. 249640 and 249637).
GS0042035 Litton Bionetics, Inc. (1983) Mutagenicity Evaluation of
Chevron Acephate Technical SX-1102 in the Sister Chrcmatid
Exchange Assay _in vivo in mouse bone marrow. Submitted by
Chevron Chemical CcTTEPA Ace. No. 249640 and 249637).
GS0042037 "Modified Ruehler Test for the Skin Sensltization Potential of
Chevron Acephate Technical (SX-1102)."Study No. SOCAL 1840.
Chevron Environmental Health Center. August 9, 1982. Submitted
by Chevron Chemical Company. (EPA Ace. No. 248969).
103
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Standard
GS0042038 Mortelmans, K.E.; Riccio, E.S.j Shepherd, G.F. (1980) In Vitro
Detection of Mltotic Crossing-Over, Mitotic Gene Conversation,
and Reverse Mutation with S. Cerevisiae D7 for Seven Pesticides.
Project No. LSU-7558-20. Prepared by SRI International. (EPA
Ace. Nos. 251894 and 251895).
GS0042039 Evans, E.L.; Mitchell, A.D. (1980) An evaluation of the effect
of acephate on sister chrcraatid exchange frequencies in cultured
Chinese hamster ovary cell.s Project No. LSU-7558. Prepared by
SRI Internatonal. (EPA Ace. Nos. 251894 and 251895).
GS0042040 Kirkhart, B. (1980) Micronucleus test on acephate. Project
No. LSU-7558-19. Prepared by SRI International. (EPA Ace.
Nos. 251894 and 251895).
GS0042041 Environmental Health & Toxicology Laboratories of Standard Oil
Company of California (1978) The Eye Irritation Potential of
Orthene 85 Concentrate (CC4233) S-1328, Socal/33:71, dated
September 13, 1978; received at EPA November 20, 1979; submitted
by Chevron Chemical Co. (EPA Ace. No. 241356).
GS0042042 Chevron Chemical Co. (1974) Rat Acute Oral - Orthene 85.
Socal No. 552. Submitted Chevron Chemical Company (EPA Ace.
Nos. 236863, 236864).
GS0042043 Chevron Environmental Health and Toxicology Lab (1972) Primary
Dermal Irritation - Rabbit. Report No. 314. Submitted by
Chevron Chemical Company (EPA Ace. No. 112341).
GS0042044 Chevron Chemical Co. (1971) The Eye Irritation Potential of
Orthene 75 S. Socal No. 273. Submitted by Chevron Chemical
Company (EPA Ace. No. 112341).
GS0042045 Chevron Environmental Health Center (1982) 21-day Dermal -
Rabbit; Socal No. 1122; submitted by Chevron Chemical Company
(EPA Ace. No. 248019).
GS0042046 Chevron Environmental Health Center (1972) Acute Inhalation -
Rat; Socal No. 315; Submitted by Chevron Chemical (EPA Ace.
No. 112341).
GS0042047 Chevron Chemical Co. (1984) Orthene 753 Soluble Powder (EPA Reg.
No. 239-2418), Residue Chemistry Data. Received April 25, 1984,
under PP#4F3098. (EPA Ace. No. 072678).
104
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Standard
GS0042048 Chevron Chemical Co. February 11, 1980, residue data for acephate
in mint hay, mint oil, and spent mint hay; studies T-3172 thru
T-4133 in Pesticide Petition #OE2323. (Ace. No. 099240).
GS0042049 Chevron Environmental Health & Toxicology (1984). Acute Dermal
Toxicity of Methylthioacetate in Adult Male and Female Rats;
Interim Report Socal No. 2207. Submitted by Chevron Chemical
Company and received May 22, 1985.
GS0042050 Hazelton Laboratories America Inc. (1980), Acute Inhalation in
Rats; revised final report #2107-104. Submitted by Chevron Chemical
Company and received May 22, 1985.
GS0042051 Elars Bioresearch Laboratories, Inc. (1980). Acute Dermal Toxicity
Chevron Methylthioacetate; Revised Report and Ophthalmic Findings;
Project 1534.8. Submitted by Chevron Chemical Company and received
May 22, 1985.
GS0042052 Chevron Environmental Health & Toxicology (1980). The Skin
Irritation Potential of Methylthioacetate; Socal No. 1631/39:131.
Submitted by Chevron Chemical Company and received May 22, 1985.
GS0042053 Chevron Environmental Health & Toxicology (1980). The Skin
Sensitization Potential of Methythioacetate; Socal No. 1632/35:106.
Submitted by Chevron Chemical Company and received May 22, 1985.
GS0042054 Chevron Environmental Health & Toxicology (1980). The Eye Irritation
Potential of Methylthioacetate; Socal No. 1630/39;133. Submitted by
Chevron Chemical Company and received May 22, 1985.
GS0042055 Chevron Environmental Health & Toxicology (1979). The Eye Irritation
Potential of Methylthioacetate; Socal No. 1560/39;92. Submitted by
Chevron Chemical Company and received May 22, 1985.
GS0042056 Chevron Environmental Health & Toxicology (1985). Final Report Mouse
Lymphoma Mutagenicity Screen Methylthioacetate: Socal No. 2338.
Submitted by Chevron Chemical Company and received May 22, 1985.
105
-------
Appendix II-3
OMB Approval No. 20004468 (Expires 12-31-83)
EPA REGISTRATION NO.
FIFRA SECTION 3(C)(2)(B) SUMMARY SHEET
PRODUCT NAME
APPLICANTS NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to tht requirement to submit "generic" data imposed by the FIFRA action 3(C)(2)(B) notice contained ir. the referenced
Guidance Document, I am responding in the following manner
Q1. 1 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:
D1 I have entered Into an agreement with one or more other registrants under FIFRA section 3{C)(2HB){ii> to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
D 3. 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.)
REGISTRANT'S AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
EPA Form 8880-1 (1042)
-------
Appendix II-A
OMB Approval No. 20O04468 (Expires: 12-31-83)
(To qualify, certify ALt, four items)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. 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
(This firm or group of firms is referred to below as "my firm".)
2. My firm is willing to develop and submit 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:
3. My 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
bound 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
to the following (irm(s) on the following date(s):
NAME OF FIRM
DATE OF OFFER
However, none of those firm(s) accepted my offer.
4. My 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
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
SIGNATURE
DATE
EPA Form 86804 (10-821
-------
Appendix III-l
EPA Registration No.
PRODUCT SPECIFIC DATA REPORT
Guidance Document for_
Date
Registration
Guideline No.
§15b\20
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
63-8
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#
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
-------
Appendix III-l (continued)
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
Plammability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral LD-50,
rat
Acute dermal
LD-50
Acute inhalation,
LC-50 rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
required
for ray
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID#
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
-------
APPENDIX IV-1
Chapter I—Environmental Protection Agency
it obtained the data from anothe
(identify); applicant copied day
?m a publication; applicant obt
p>py of the data from EPA).
) The applicant shall submit
his Application a statement that
in iti evaluation of the propertie
cacyAand safety of the form\
end-use product, may not consid
data ks supporting the appl
except the following data:
(1) Tne data the applicant has sub-
mitted tfc EPA under paragraph (b) of
this sectibn:
(2) OtHpr data pertainir/g to the
safety of we product's active ingredi-
ents. ratheV than to the sqffety of the
end-use proauct: and
(3) Existing tolerances, food additive
regulations, ^exemptions/ and other
clearances issued undey the Federal
Food. Drug, and Cosmetic Act.
n who origlnal-
to EPA (or its
on or after Janu-
ort an application
xperimental use
nt adding a new
ration, or for
the applicant
data\submltter have
em on the
amount and thfe terms \pf payment of
any compensation thattmay be pay-
able under FIFFSA section
3(cXlXDXli)/with regard\to approval
of the application), the applicant shall
submit to EPA a statement that he
has furalsned to each sucr\ identified
original data submitter
(DA notification of the applicant's
intent to Apply for registration, includ-
ing the proposed product nami
(2) An offer to pay the person com-
pensation, with regard to the approval
of the/ application, to the extent re-
quires by FTFRA sections 3(c)U)(D)
and Mc)(2XD):
(3/An identification of the ite\n(s)
of «ita to which the offer applies:
-------
§ 162.10
The use classification^) as pre-
scribed In paragraph (J) of this section.
(2) Prominence and legibility. (I) AM
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
consplcuousness (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) AH required label text must:
(A) Be set In 0-polnt or larger type:
(B) Appear on a clear contrasting
background: and
(C) Not be obscured or crowded.
(3) Lontruape 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 English and
other-language versions of the label-
Ing.
(4) Placement of Label—
-------
allel to It. The registration number
and the required Identifying phrase
shall not appear In such a manner as
to suggest or Imply recommendation
or endorsement of the product by the
Agency.
(f) Producing establtthment* 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 wa« 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 statement 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 Ingredient*.
Unless the Ingredient statement Is a
complete analysis of the pesticide, the
term "analysts" shall not be used as a
heading for the Ingredient statement.
(2) Poiltlon of ingredient itatement.
(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.
Till* 40—Protection of tnvtronment
(ID The text of the Ingredient state-
ment must run parallel with other
text on the panel on which It appears.
and must be clearly distinguishable
from and must not be placed In the
body of other text.
(3) Name* 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
baa been established, the chemical
name alone shall be used. In no case
will the use of a trademark or propri-
etary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of Section 28(cX«>.
(4) Statements of percentage*. The
percentages of Ingredients shall be
stated In terms of welght-to-welght.
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 tinted percentage*.
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 pres-
ent.
(6) Deterioration. 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
tdatel."
(II) The product must meet all label
claim* up to the expiration time Indi-
cated on the label.
(7) /n«rt ingredient*. The Adminis-
trator may require the name of any
Chapter I—Environmental Protection Agency
A. i I.MUX IV-1
(continued)
$ 162.10
Inert IngredlenUiO lo be listed In the
Ingredient statement If he determines
that such Ingredlcnt(s) may pose a
hazard to man or the environment.
(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. Sperlflr require-
ments conrernlne content, placement.
type size, and prominence are given
below.
(I) Required front panel statement*.
With the exception of the child
hazard warning statement, the text re-
quired on the front panel of the label
Is determined by the Toxlclty Catego-
ry of the pesticide. The category Is (w-
signed on the basis of the highest
hazard shown by any of the Inrilcnlors
In the table below:
On* 10.
e^k flffwN .
1
Up ID *n) Hrln^nq SO
ingtg
Up 10 MY) Inekrifeq J
mg/M»>
l)p to ind Me«if««on t< '?
houn
W
Fram MX) thru Vmn ni« nwii «mn «
»5
n*»«l«* >*w«>. *n mQ/
n«MM MQM MMIkw
7?»K«»«
(I) Human hazard signal word—(A)
Toricity Category I. All pesticide prod-
ucts meeting the criteria of Toxlclty
Category I shall bear on, the front
panel the signal word "Danger." In ad-
dition If the product was assigned to
Toxlclty Category I on the basis of Its
oral. Inhalation or dermal toxlclty (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) Toitcitv Category //. All pesti-
cide products meeting the criteria of
Toxlclty Category II shall bear on the
front panel the signal word "Warn-
ing."
(C) Toxicity Category III. All pesti-
cide products meeting the criteria of
Toxlclty Category III shall bear on
the front panel the signal word "Cau-
tion."
(D) Toxicitv Category IV. All peatl-
clde products meeting the criteria of
Toxlclty Category IV shall bear on the
front panel the signal word "Caution,"
(F) Uir of tignal ii'nrds. Use of any
signal wortKM associated with « higher
Toxlclty 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. Tn no case
shall more than one humnn hazard
signal word appear on the front panel
of a label.
(II) Child hazard warning. Fvery 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 If 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—(A) Toxicity Category I. A
statement of practical treatment (first
aid or other) shall appear on the front
panel of the label of all pesticides fall-
Ing Into Toxlclty Category 1 on the
basis of oral. Inhalation or dermal tox-
lclty. The Agency may. however.
permit reasonable variations In the
placement of the Mnlrrnrnt of prarll.
-------
§ 162.10
cal treatment Is some reference such
as "See statement of practical treat-
ment on back panel" appears on the
front panel near the word "Poison"
and the skull and crossbones.
(B) Other toxiclly cateyoritt. The
statement of practical treatment Is not
required on the front panel except as
described In paragraph (hHlMIIIHA) 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 (h)(3) 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 be 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:
Till* 40—Prelection of Environment
S«ndur>r)«r_
Abovt 5 to 10.
A0ov« 10 to «»....
Abov* IS to 30 ..
Cvw »
"33d
wart, if
of rrjrjctiof
CMo> «b«orb«l
tvouph fUnl. Do not bnM»w v«x» (Anl or tpr*y
fnM). DO net QM h «*«*. on ndn. or en cWMng
Vrouan r» •*) Oa no* bnj«t» v^tn [dMI or
«r*T mHO Do nal aM In xyo. on tUn. or on
£i00V^£ I A|*8n3JfKii) Ar^ f#4 tl9rvnvr4t rwqi^vr]. |.
HcnnM • »-tr»o.»J |i*«l.d or tt»orb«l Ihrauon •«
Ikln). A««d tr»«»T "Ml
A«otrJ oenud ««n dih (vyw
prttM ft-M *« fttMronl raqi»«d 1
IMo pr*caiAin«ry tti1«m«nls r*oufr«d )
(or It*
DC not art to *f«. on pUn. or en
otoMxo, Ww ooggtM or taei ***J m) nMw
. HwnM «r IrM I •M*»r«l
lnn*«d)
on DUn. 4 )
(II) Environmental hazards. Where a
hazard exists to non target organisms
excluding humans and domestic ani-
mals, precautionary statement* 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-
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
Chapter I—Environmental Protection Agency
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 LC» of I ppm or toss.
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 avlun acute oral LD» of 100
rngAg or less, or a suhacnle dietary
LC» of 500 ppm or IMS. the statement
"This Pesticide Is Toxic to Wildlife" Is
required.
(D> If either accident history or IMd
studies demonstrate that use of the
pesticide may result In fatality to
birds, fish or mammals, the statement
Al , l.tJDIX IV-1
(cont inued)
S 163.10
"This pesticide Is extremely toxic to
wildlife (fish)" Is required.
For all outdoor uses other than
Aquatic application* (he label must
bear the caution "Keep out of lakes.
ponds or streams. Or> not contaminate
water by cleaning of equipment or dis-
posal of wastes."
(JIM Physical or rhrmtcal harnrif*
Warning statement.* nn the flammahll
Ity or explosive characteristic* of the
pesticide are required as follows'
(A) enrssimtrvo CONTJUNVHII
•I
ri.lt. po
fl«m. ortvnlon X mo,. **/.
of 6 h horn ITM n»m«
*• olh* (r»
Al or tntowftr r
*»••» W r t«d no) ovw (o- F..
Abovrj to- r ml not ow ijfi ••_ kn.
I. «-v» hMlrx) ..^^M Ho nnl orv^... ™ W^..,.
1° t*mo«t«i(i»t« rihnv* I TO' f ^^ ^^.^^
«|
*. 9*4 l inM nr «lry4 nMr hrttri or nrrm
On not puncture or InrfriwaM cvttjfcM* Fvprmv* in
iwrn^r-
(B) Mo—XHimnn COHTMtrrll
(I) OfrrcMonj /or Vie—(1) General
requirements—(I) Adequacy and clar-
ity of direction). Directions for use
must be staled In terms which can be
easily read and understood by the
average person likely to use or to au-
pervlne 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 effect* on the
environment.
(II) Placrmfnt of directions for we.
Directions may appear on any portion
of the label provided that they are
conspicuous enough to be easily read
by the user of the pestlcltie product.
Directions for use may appear on
printed or graphic matter which ac-
companies th* pesticide provided that:
(A) If required by the Agency, such
printed or graphic matter to umirrly
attached to each package of (he 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 "Sfp di-
rections In the enclosed circular:" and
(C) The Administrator determlnw
that It Is not necessary for such direr
tlons to appear on the label.
(Ill) Xxceptlons to requirement for
direction for use—(A) Detailed direc-
tions for use may be omitted from la
bellnft of pesticides which are Intended
for use only by manufacturers of prod-
ucts other than pe.illrldc pro/tun* In
their regular manufacturing process***.
provided that:
-------
§ 162.10
(/) The lube! 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;
(£) The product will not come Into
the hands of the general public except
after Incorporation Into finished prod-
ucts: and
{«*) 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 advene ef-
fects on man or the environment: and
O) 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 product* which are Intended for
use only by formulatora In preparing
pesticides for sale to the public pro-
vided that:
(1) There Is Information readily
available to the formulaton on the
composition, toxlclty, 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, mixing,
or repacking for use as a pesticide and
specifies the type(s) of pesticide prod-
ucts Involved:
(3) 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.
T1H. 40— ProlocMon of Environment Chopl.r I—Environmental rVofedlon Agency
AP'M.NDIX IV-1
(continued)
(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.KXJ) Immedi-
ately under the heading "Directions
for Use."
(II) 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."
(Ill) The slte<8) of application, as for
example the crop*, 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.
(vl) The method of application, In-
cluding Instructions for dilution. If re-
quired, and lype(s) of application ap-
paratus or equipment required.
(vll) The frequency and timing of ap-
plications necessary to obtain effective
result* without causing unreasonable
advene effects on the environment.
(vllD 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 direction* concerning
the storage and disposal of the pesti-
cide and It* container, meeting the re-
quirement* of 40 CFR Part 166. These
Instructions Khali 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 I 162.1(XhxlXlv).)
(x) Any limitation* or restriction on
use required to prevent unreasonable
adverse effects, such as:
(A) Required Interval* 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)
(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.
(F) Other pertinent Information
which the Administrator determines
lo be necessary for the protection of
man and the environment.
(J) Statement of Vxr Classification.
By October 22. 1978. all pesticide prod-
ucts must bear on their labels a state-
ment of use classification as described
In paragraph* (J)( I) and (2) of this sec-
tion. Any pesticide product for which
some uses are classified for general use
and others for restricted use shall be
separately labeled according to the la-
beling standards set forth In this sub-
section, and shall be marketed as sepa-
rate products with different registra-
tion numbers, one bearing directions
only for general tise(s) and the other
bearing directions for restricted use(s)
except that. If a product has both re-
stricted use(s) and general use(s). both
of these uses may appear on a product
labeled for restricted use. Such prod-
ucts shall be subject to the provisions
of I 162.IO(JK2).
(I) General Use Classification. Pesti-
cide products bearing directions for
use(s) classified general shall be la-
beled with the exact words "General
Classification" Immediately below the
heading "Directions for Use." And ref-
erence to the general classification
that suggests or Implies that the gen-
eral utility of the pesticide extends
beyond those purposes and uses con-
tained In the Directions for Use will be
considered a false or misleading state-
ment under the statutory definitions
of mlsbrandlng.
(2) Restricted Vif. Classification.
Pesticide product* bearing direction
for use(s) classified restricted shall
bear statements of restricted use clas-
sification on the front panel as de-
scribed below:
CD Front panel statement of restrict-
fit use classification. (A) At the top of
the front panel of the label, set In type
Of the same minimum sizes as required
for human hazard signal words (see
table In I 162 10(hXlxiv». and appear-
ing with sufficient prominence relative
to other text nnd graphic material on
the front panel to make It unlikely lo
be overlooked under customary conrtl
Lions of purchase and use. the state-
ment "Restricted tlse Pesticide" shall
appear.
(B) Directly below this statement on
the front panel, a summary statement
of the terms of restriction Imposed as
a precondition to registration shall
appear. If use Is restricted to certified
applicators, the following statement is
required: "For retail sale to and use
only by Certified Applicators or per
sons under their direct supervision and
only for those uses covered by the Cer
lifted Applicator's certification." If.
however, other regulatory restrictions
are Imposed, the Administrator will
define the appropriate wording for the
terms of restriction by regulation.
(k) Advertising. t Reserved!
MO FR 28288. July 3. 1975: 40 FR 3J32P.
Aug. 1. IB75: 40 FR 36S7I. AUR. 21. 1975. «.«
•mrndrri At 43 FR S78S. Frb. 9. 19781
I 1*2.11 Criteria for itMrrmlniillnni of un-
\ rra*nnahtt •dvrrer rffrrl*.
Criteria for Issuance of IVoticf nf
Intfal to Deny Rrgistration. Cancel
Registration, or to Hold a Heahntr -
(1) Prksumptton, (I) A rebutUtrie pre-
sumption shall arise that a ttbtlce of
Intent toVleny registration pursuant to
section 3rcX8) of the Act. jl notice of
Intent to cancel registration pursuant
to section VbXl) of th% Act. or a
notice of InUint to holer a hearing to
determine whether Ufe registration
should be cancelled or denied, as ap-
propriate, shall T>e b&ued. upon a de-
termination by thVAdmlnlslrator that
the pesticide meetX or exceeds any of
the criteria for rJSkWt forth In para-
graph (a)(3) of t/m section. Upon such
determination^/ the \ Administrator
shall Issue notice by cvtlfled mall to
the applicant or reglsf.raVit. as the case
may be. stating that theVppllcant or
registrant/has the opportunity lo
submit evidence In rebuttaj of such
presurmnlon In accordance win para-
graph /ax«) of this section. T>ie appli-
cant pr registrant shall have fdrty five
M5)yflays frorn the date such notice Is
sent to submit evidence In rebuttal of
the presumption: provided, however.
at for good cause shown the AHnVli
fstrator m»y grant an additional slx\
-------
©}
&\
©
©
no A j
(UK;I
r
>
>
i
>
>
,
(8)
P"! c »uiM>I
STORAGE AMD
DISPOSAL
rnnn
PRODUCT
NAME
• Clrvt tifintO'lul
in ni nr.ni ruling Jt
IOIA| IOOIH1X
^U mis rnomici COMMAS cos (x rtnc*uo»/ C
KEEP OUT Or REACH OF CHILDREN ^
CAUTION <
$iti[ij(Mi or nuric't IBI "iiniii
» riiittrn •
1 OS 5»»l ~— -— ^-^^^
urn n» r^jT tf N.
JSi ^i«nniM>^ini nn
"0«"0 ^J^ ^^
Nil Cf)»
-------
PRECAUTIONARY STATEMENTS
HAJAflDS TO HUMANS
(I OOUeSTC AN1MALSI
DANGER
ENWONUENTAL MAJA'OOS
on
rcm use
I • • <*>bMn « F«Mr* fc»
*W m»«uc1 X •
RE CNTRY STATEMENT
ft
STORAGE AND
DISPOSAL
—
.
crxw
RESTRICTED USE
PESTICIDE
for rctttl illr It md »tt enlf br CtrtUltd Apptlcitort
or ffrioni under (Stir dUitt luptrvlilon ixd onljr f«r
thotc »tti cotertd bjr Iht C«rtHl»d Appllcnori C*rllfl-
PRODUCT
NAME
ACTVt MORtDCNT
TOTAL 10000%
T(«S PRODUCT CONTAM9 t*S O* PEN OAJUOM
KEEP OUT OF REACH OF CHILDREN
DANGER—POISON
STATfUJNT Of PRACTCAt. IRtATMINT
r OH
r
set sot
AKXTQNAL PHTCAUTIONAAY
MfQ BY
TOWN. S^TATE =======
S^ESTABtr^HUENT NO r:
EPA nEC^ISTRATOH NO
MET CONTENTS:
CftOP
CHOP
CHOP
CHOP
CHOP
•VAMUMry STATEMENT
•a
•o
n>
o.
<
i
-------
APPLNDIX IV-2
LABELING REQUIREMENTS OP THE FIFRA, AS AMENDED
ITEM
1
2
3
II
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
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unlt area
All products
All products
All products
PLACEMEN!' ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
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.
1 rimed lately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Iiimod lately
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.
-------
APPENDIX IV-2 (continued)
ITEM
70
7D
7E
8
&A
HB
LABEL ELEMENT
Skull & cross-
bones and word
POISON (In red)
Statement of
practical
treatment
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
KM v i rot HIIOI il.nl
hazards
APPLICABILITY.
OP REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or Inhala-
tion toxic Ity
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
1, II, and III
All products
PLACEMENT ON LABEL
REWIRED
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
Must be grouped under the headings In
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental ha/.ards Include? boo
caution where applicable.
-------
APPENDIX IV-2 (continued)
ITEM
8C
9A
9C
10A
IOC
10D
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°F
All restricted
products
All products
All
cholinesterase
inhibitors
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Inmed lately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Imnediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Must be set apart and clearly distin-
guishable from from other directions
for use.
May be in metric as well as U.S. units
-------
Appendix IV-3
PHYSICAL-CHEMICAL HAZARDS
Criteria
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.
Required Label Statement
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 frcm
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.
-------
Appendix IV-4
STORAGE AND DISPOSAL INSTRUCTIONS FOR PESTICIDES
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 lab3! under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL." The STORAGE AND DISPOSAL heading
must appear in the minimum type size listed below:
Size of label
front panel in
square inches
10 and under
Above 10 to 15
Above 15 to 30
Over 30
Required type size
for the heading
STORAGE AND DISPOSAL
(all' capitals)
.... .8 point
. . . . 10 point
. . . . 12 point
Storage and disposal instructions must be set apart and
clearly distinguishable from other directions for use.
Blocking storage and disposal statements with a solid line is
suggested as a means of increasing their prominence.
A. 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.
-------
Appendix IV-U
(continued)
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize 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.
B. Pesticide Disposal Instructions:
The label of all products, except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal. The statements listed below contain the exact wording
that must appear on the label of these products:
1. The labels of all products, except domestic use, must
contain the statement, "Do not contaminate water, food,
or feed by storage or disposal."
2. Except those products intended solely for domestic use,
the labels of all products that contain active ingredients
appearing on the "Acutely Hazardous" Commercial Pesticide
Products List (RCRA "E" List) at the end of this appendix
or are assigned to Toxicity Category I on the basis of
oral or dermal toxicity, skin or eye irritation potential,
or Toxicity Category I or II on the basis of acute inhala-
tion toxicity must bear the following pesticide disposal
statement:
"Pesticide wastes are acutely hazardous. Improper dis-
posal 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."
The labels of all products, except those intended for
domestic use, containing active or inert ingredients
that appear on the "Toxic" Commercial Pesticide Products
List '(RCRA "F" List) at the end of this appendix or
presently meet any of the criteria in Subpart C, i»0 CFR
261 for a hazardous waste must bear the following pesticide
disposal statement:
-------
3.
Appendix IV-4
(continued)
"Pesticide wastes are toxic. 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."
Labels for all other products, except those intended for
domestic use, must bear the following pesticide disposal
statement:
"Wastes resulting from the use of this product may be
disposed of on site or at an approved waste disposal
facility."
Products intended for domestic use only must bear the
following disposal statement: "Securely wrap original
container in several layers of newspaper and discard in
trash."
C. Container Disposal Instructions
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. All products intended for domestic use 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.
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Appendix IV-4
(continued)
2. The labels for* 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 b^ 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 b^ 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. Empt^ 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
reusedlj dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empt^ 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 empt^ cylinder for reuse (or
similar wording)
Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
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Appendix IV-4
(continued)
Pesticides that are hazardous wastes under 40 CPR 26l.33(e) and (f)
when discarded.
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients, (no inerts):
Acrolein
Aldicarb
Aldrin
Allyl alcohol
Aluminum phosphide
4-Aminopyridine
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p-Chloroaniline
Cyanides (soluble cyanide salts, not specified elsewere)
Cyanogen chloride
2-Cyclohexyl-4,6-dinitrophenol
Dieldrin
0,0-Diethyl S-[2-ethylthio)ethyl] phosphorodithioate
(dlsulfoton, Di-Syston)
0,0-Diethyl 0-pyrazinyl phosphorothioate (Zinophos)
Diraethoate
0,0-Dimethyl 0-p-nitrophenyl phosphorothioate (methyl parathion)
4,6-Dinitro-o-cresol and salts
4,6-Dinitro-o-cyclohexylphenol
2,4 Dinitrophenol
Dinoseb
Endosulfan
Endothall
Endrin
Famphur
Pluoroacetamide
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methomy1
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA, schradan)
Parathion
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Appendix IV-4
(continued)
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients continued;
Phenylmereuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
Strychnine and salts
0,0,0,0-Tetraethyl dithiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate
Thallium sulfate
Thlofanox
Toxaphene
Warfarin
Zinc phosphide
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Appendix IV-4
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Active Ingredients;
Acetone
Acrylonitrile
Amitrole
Benzene
Bis(2-ethylhexyl)pthalate
Cacodylic acid
Carbon tetrachloride
Chloral (hydrate)
Chlordane (technical)
Chlorobenzene
4-Chloro-m-cresol
Chloroform
o-Chlorophenol
4-Chloro-o-toluidine hydrochloride
Creosote
Cresylic acid
Cyclohexane
Decachlorooctahydro-l,3>4-metheno-2H-cyclobuta[c,d]-pentalen-2-one
(kepone, chlordecone)
l^-Dibromo-S-chloropropane (DBCP)
Dibutyl phthalate
S-3,3-(Dichloroallyl diisopropylthiocarbamate (diallate, Avadex)
o-Dichlorobenzene
p-Dichlorobenzene
Dichlorodifluoromethane (Preon 12®)
3,5~Dichloro-N-(l,l-dimethyl-2-propynyl) benzamide (pronamide,Kerb)
Dichloro diphenyl dichloroethane (DDD)
Dichloro diphenyl trichloroethane (DDT)
Dichlorethyl ether
2,1-Dichlorophenoxyacetic, esters and salts (2,4-D)
1,2-Dichloropropane
1,3-Dichloropropane (Telone)
Dimethyl phthalate
Ethyl acetate
Ethyl Jj ,4 '-dichlorobenzilate (chlorobenzilate)
Ethylene dibromide (EDB)
Ethylene dichloride
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene
Hexachlorocyclopentadiene
Hexachloroethane
Hydrofluoric acid
-------
Appendix IV-4
(continued)
"Toxic" Commercial Pesticide Products (RCRA "P" List)
Active Ingredients;
Isobutyl alcohol
Lead acetate
Lindane
Maleic hydrazide
Mercury
Methyl alcohol
Methyl bromide
Methyl chloride
2,2'-Methylenebls (3,4,6-trichlorophenol) (hexachlorophene)
Methylene chloride
Methyl ethyl ketone
4-Methyl-2-pentanone (methyl isobutyl ketone)
Naphthalene
Nitrobenzene
p-Nitrophenol
Pentachloroethane
Pentachloronitrobenzene (PCNB)
Pentaclorophenol
Phenol
Phosphorodithioic acid, 0,0-diethyl, methyl ester
Propylene dichloride
Pyridine
Resorcinol
Safrole
Selenium disulfide
Silvex
1,2,4,5-Tetrachlorobenzene
1,1,2,2-Tetrachloroethane
Tetrachloroethylene
2,3,4,6-Tetrachlorophenol
Thiram
Toluene
1,1,1-Trichloroethane
Trichloroethylene
Trichloromonofluoromethane (Preon 11®)
2,4,5-Trichlorophenol
2,4,6-Trlchlorophenol
2,4,5-Trichlorophenoxyacetic acid (2,4,5-T)
Xylene
-------
Appendix IV
(continued)
"Toxic" Commercial Pesticide Products (RCRA "P" List)
Inert Ingredients:
Acetone
Acetonitrile
Acetophenone
Acrylic acid
Aniline
Benzene
Chlorobenzene
Chloroform
Cyclohexane
Cyclohexanone
Dichlorodifluororaethane (Preon 12®)
Diethyl phthalate
Dimethylamine
Dimethyl phthalate
1,4-Dioxane
Ethylene oxide
Formaldehyde
Formic acid
Isobutyl alcohol
Meleic anhydride
Methyl alcohol (methanol)
Methyl ethyl ketone
Methyl methacrylate
Naphthalene
Saccharin and salts
Thiourea
Toluene
1,1,1-Trichloroethane
1,1,2-Trichloroethane
Trichlorofluororaethane (Freon 11®)
Vinyl chloride
Xylene
-------
DRAFT
6560-50
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDES AND TOXIC SUBSTANCES
[OPP-36103;FRL ]
PESTICIDE REGISTRATION STANDARDS; AVAILABILITY FOR COMMENT
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of Availability of draft Standard for comment,
SUMMARY: This notice announces the availability of certain
draft pesticide Registration Standard documents for comment.
The Agency has completed a review of each listed pesticide
and is making available a document describing its regulatory
conclusions and actions.
DATE: Written comments on each Registration Standard should
be submitted on or before [insert date 60 days after date of
publication in the FEDERAL REGISTER].
ADDRESSES: Three copies of comments identified with the
docket number listed with each Registration Standard should
be submitted to: By mail:
Information Services Section,
Program Management and Support Division (TS-757C),
Office of pesticide Programs,
Environmental Protection Agency,
401 M St., SW.,
Washington, D.C. 20460.
85P-2132
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-2-
In person, deliver comments to:
Rra. 236, CM# 2,
1921 Jefferson Davis Highway,
Arlington, VA.
Information submitted as a comment in response to this
notice may be claimed confidential by marking any part or all of
that information as "Confidential Business Information" (Cbl).
Information so marked will not be disclosed except in accor-
dance with procedures set forth in 40 CFR Part 2. A copy of
the comment that does not contain CBI must be submitted for
inclusion in the public docket. Information not marked confi-
dential will be included in the public docket without prior
notice. The public docket will be available for public
inspection in Rm. 236 at the address given above, from 8 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: To request a copy of a
Registration Standard, contact Frances Mann of the Information
Services Section, in Rm. 236 at the address given above
(703-557-3262). Requests should be submitted no later than
[insert date 30 days after date of publication in FEDERAL
REGISTER] to allow sufficient time for receipt before the
close of the comment period.
For technical questions related to each Registration
Standard, contact the product Manager listed for that
Standard, at the phone number given.
-------
-3-
SUPPLEMENTARY INFORMATION: The Environmental Protection
Agency conducts a systematic review of pesticides to determine
whether they meet the criteria for continued registration
under section 3(c)(5) of the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA). That review culminates in the
issuance of a Registration Standard, a document describing
the Agency's regulatory conclusions and positions on the
continued registrability of the pesticide. In accordance
with 40 CFR 155.34(c), published in the FEDERAL REGISTER on
November 27, 1985 (50 FR 48998), before issuing certain
Registration Standards, the Agency makes the draft document
available for public comment.
Draft Registration Standards for the following pesticides
are now available:
Name of pesticide Docket number Contact person
1. Acephate 30560-19-1 William H. Miller
Product Manager 16
(703-557-2600)
2. Amitraz 33089-61-1 Jay Ellenberger
Product Manager 12
(703-557-2386)
3. Chlordimeform 6164-98-3 Jay Ellenberger
4. Copper sulfate 1344-73-6 Richard Mountfort
Product Manager 23
(703-557-1830)
5. Oryzalin 19044-88-3 Robert Taylor
Product Manager 25
(703-557-1800)
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-4-
Copies of each Registration Standard may be obtained from
the Agency at the address listed under For Further Information
Contact. Because of the length of each Standard and the
limited number of copies available for distribution, only
one copy can be provided by mail to any one individual or
organization. Each Registration Standard is also available
for inspection and copying in EPA Regional Offices at the
addresses listed below after [insert date 30 days after date
of publication in the FEDERAL REGISTER].
LIST OF EPA REGIONAL OFFICES
Pesticides Branch
EPA - Region I
JFK Federal Building
Boston, MA 02203
Contact person: HarulU Kdmiidieg— £if\e\r£i,\j Triolo
Pesticides Branch
EPA - Region II
Woodbridge Avenue
Edison, NJ 08837
Contact person: -F-rod Kozak DttVt
EPA - Region III
Curtis Building
6th and Walnut Sts.
Philadelphia, PA 19106
Contact person: John Smith
Pesticide and Toxic Substances Branch
EPA - Region IV
345 Courtland St., NE
Atlanta, GA 30365
Contact person: Kent Williams
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-5-
Toxic Materials Branch
EPA - Region v
230 South Dearborn St.
Chicago, IL 60604
Contact person: Lavarre Uhlken
Pesticide and Toxic Substances Branch
EPA - Region VI
1201 Bint St.
Dallas, TX 75270
Contact person: Norman Dyer
Pesticide and Toxic Substances Branch
EPA - Region VII
324 East llth St.
Kansas City, MO 64106
Contact person: Leo Alderman
Toxic Substances Branch
EPA - Region VIII
1860 Lincoln St., Suite 900
Denver, CO 80295
Contact person: -R^h H^M^g- ~&ecLn Q
Hazardous Materials Branch
EPA - Region IX
215 Fremont St.
San Francisco, CA 94105
Contact person: Manoy Frost i~dl4ri^ Pe.rrc"f~
Air & Water Division
EPA - Region X
1200 6th Ave.
Seattle, WA 98101
Contact person: Lyn Fgandoon dhucK Shenh(
Dated:
Director,
Office of Pesticide programs
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