&EPA
UniMdStras
Efmronimmai ProtMSton
AgMicy
Off la of
PwteW
WHhington DC 20460
March 1988
Guidance for the
Reregistration of
Pesticide Products
Containing Captan
as the
Ingredient
-------
GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
CAPTAN
AS THE ACTIVE INGREDIENT
EPA CASE NUMBER 0120
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D. C. 20460
March 6, 1986
-------
TABLE OF CONTENTS
Introduction I
I. Regulatory Position and Rationale 4
II. Requirement for Submission of Generic Data 36
III. Requirement for Submission of Product—Specific Data 39
IV. Submission of Revised Labeling 131
A. Label Contents . 131
B. Collateral Information 137
V. Instructions for Submission 138
1
-------
APPENDICES
Page
1 1—1 Guide to Bibliography 41
11—2 Bibliography 43
11—3 FIFRA §3(c)(2)(B) Summary Sheet — EPA Form 8580—1 . . 158
11—4 Certification of Attempt to Enter Into an Agreement
with Other Registrants for Development of Data
EPA Form 8580—2 159
1 1 1—1 Product Specific Data Report (End—Use Products) . . 160
IV—1 40 CFR 162.10 Labeling Requirements 164
IV—2 Table of Labeling Requirements 176
IV—3 Physical/Chemical Hazards Labeling Statement. . . . 179
IV—4 Storage Instructions 180
IV—5 Pesticide Disposal Instructions 181
IV—6 Container Disposal Instructions 182
ii
-------
I NTRODtJCTION
The Federal Insecticide, Fungicide, arid Rodenticide Act
(FIFRA 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 generally 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 ma Registration Standard,
on each pesticide and its uses. The Agency may determine that,
iii order to remain in compliance with FIFRA, the registrant
must provide additional data to support existing registrations,
modify its product labels to provide additional precaution-
ary 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 unreasonable adverse effects on the environ-
ment. The Registration Standard may lead to initiation of a
Special Review if it. appears that use of the product may cause
unreasonable adverse effects on the environment. The Special
Review can result in a decision by the Agency to require a change
in the conditions of registration, suspension, or cance-liation
of the registratio n.
The scientific review, which is not contained in this
Guidance Package but is available from the N ational Technical
Information Service, 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 arid will propose
regulatory actions to the extent necessary to protect the
public.
EPA has the authority under FIFRA sec. 3(c)(2)(B) to
require registrants to submit data regarding the hazards
1
-------
that may result from the intended use of the 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 of the
active ingredient) and other producers who do not qualify
for the formulator’s exemption..*
A producer who does not currently qualify but wishes
to quaLity for the formulator’s exemption may change his
his source of supply to a registered source, provided the
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,
identi fying 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. It 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 E’IFRA 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 formulator’s exemption applies to a registrant of an
product it 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
f i rm.
2
-------
PRODUCTS SUBJECT TO THE -- ACTION(S) REQUIRED TO
REGISTRATION STANDARDS PROGRAM MAINTAIN REGISTRATION
I. Products That Do Not Qualify
For The Formulator’s Exemption
A. Single Active Ingredient These products must be reregis—
Products* 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 These products will not be
Products 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 Only when additional restric—
The Formulator’s Exemption 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 Il IS 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.
3
-------
I. REGULATORY POSITION AND RATIONALE
A. INTRODUCTION
This Registration Standard describes the regulatory position
of the Environmental Protection Agency (EPA) on N—trichloromethyl—
thio—4—cyclohexene- -l,2—dicarboximide (captan), based on an
evaluation of 19 registered manufacturing—use products (MUPs), and
certain end—use products (EUPs) containing captan as the sole
ingredient. Labeling requirements, tolerances, special local
needs registrations authorized by section 24(c) of the FIFRA, as
well as registrations under section 3 of FIFRA were considered in
this analysis. The Agency sets forth the data requirements that
must be met to register or reregister products covered by this
Standard.
This Standard addresses registration requirements for current
and future MUPS and labeling requirements for EUPs. Captan MOPs
that differ appreciably from the ones described here may require
amendments to this Standard. Also, use—patterns that differ from
those described here may also require amendments to this Standard.
B. DESCRIPTION OF CHEMICAL
Captan is the acceptable common name for N—trichlorornethyl—
thio—4—cyclohexene—1,2—dicarboximide and was officially recognized
by the Interdepartmental Committee on Pest Control. Trade names
for captan are Merpan, Orthocide, SR—406, and Vancide 89. It is in
the pesticide classification known as fungicide and dicarboximides
or chlorinated organosulfur compounds.
There are 19 technical and formulation intermediate products
that may be used in the manufa turing of end—use pesticide.
The Office of Pesticide Programs Internal Control Number (EPA
Shaughnessy Number) for captari is 081301, and its CAS Number
is 133—06—2.
Captan has the following identifying characteristics:
Empirical Formula: C 9 H 8 C1 3 NO 2 S
Molecular Weight: 300.61
Structural Formula: o
H 2
H
Ii I NSCC1 3
H
H2
4
-------
Color: Pure is white crystals; technical is white to buff colored
amorphous powder.
Odor: Pure is odorless, the technical is pungent.
Melting Point: 158—164 °C
Vapor Pressure: Less than io—6 mm Hg at 25 °C.
Solubility: Practically insoluble in water, soluble in acetone,
ethanol, kerosene, xylene, chloroform, and benzene.
Stability: Regarded as stable. Decomposes slowly at the melting
point. In solution captan decomposes rapidly depend-
ing on the pH and temperature, being slower at pH 4
and rapid at pi-i above 10 at constant temperature.
Captan is a broad spectrum fungicide which is registered with
the EPA for use in the culture of both food and nonfood crops and
as an industrial fungicide. It is registered for use as a foliar
fungicide to be applied to a wide variety of fruit, vegetable,
nut, and ornamental crops, for application to seeds and plant
propagules, as a preplant application to soil and as a post—
harvest application to many fruit and vegetable crops. Captan is
also used for application to produce packing boxes, to soil and
crops grown in greenhouses, to house plants, to home gardens, to
dog and cat dusts and shampoos, and to hand soaps. It is
incorporated into plastics, oil—base paints, wall paper pastes,
textiles, paper, and cosmetics. It is registered either as single
active ingredient formulations or in combination with other
fungicides and with insecticides. It is approved by the U.S.
Food and Drug Administration for use in cosmetics and shampoos
for humans. -
Biological Activity -
Captan has been considered to be a norisystemic broad spectrum
fungicide, however, there is some information to support a
conclusion that it and one or more of its metabolites are
systemic in plants. The rate of movement in plants appears
to be slower than other systemic fungicides. Its fungicidal
activity persists on leaf surfaces for a shorter time than
thiram or captafol. In a comparative study under similar
conditions its acti.vity persisted 2.2 weeks, while thiram
and captafol’ persisted for 3.0 and 5.6 weeks, respectively
(D. Neely, Phytopathology: Vol. 60:505—510).
5
-------
There are 494 FIFRA Section 3 registered pesticide products
that bear ingredient statements that include captan as one of the
active ingredients. These products involve 118 registrants.
There are 66 FIERA Section 24(c) registered pesticide products that
bear ingredient statements that include captan as one of the
active ingredients. These products were registered by 24 States
to permit uses that meet particular special local needs. There
are also 76 intras ate registrations held by 29 registrants; these
must be registered under Section 3 of FIFRA (50 FR 25889).
•C REGULATORY POSITION AND RATIONALE
The potential risks associated with the use of pesticide
products containing captan to control fungi in agricultural and
non—agricultural applications were detailed in the Captan Special
Review Document of June, 1985. The preliminary notice of
determination concluding the special review of pesticide products
containing captari was published on June 21, 1985 (50 Federal
Register 25884—25889). In that Notice, the Agency concluded that
studies conducted on mice and rats have shown statistically
significant increases in incidences of certain tumors. Furthermore,
the agency found that the use of captan resulted in dietary and
environmental exposure that may pose unreasonable risks to human
health unless certain steps are taken. Accordingly, the Agency
proposed to cancel or deny Federal registrations of products
containing captan for use on food crops with the proviso that in
the final decision that EPA would continue any use on food where
data are submitted demonstrating that captan residues on food are
sufficiently lower than EPA ’s estimates or that alternative
application methods will sufficiently reduce dietary exposure to
captan. EPA also proposed in its preliminary determination that
protective clothing and/or equipment be worn for specific non—food
agricultural and non—agricultural uses of captan arid that revised
labeling be required on products intended eor non—food use.
The Agency has also identified certain data requirements
for captan and its metabolites for residue chemistry and toxicology,
and issued a section 3(c)(2)(B) Data Call—In Notice on April 29,
1985 requesting that data.
This registration standard for captan incorporates the
regulatory changes proposed in the preliminary determinaton of
the Special Review, with the understanding that some or all of
the food uses may be retained in the final determination. Other
regulatory determinations set forth in this Standard evolved from
the data reviewed in the process of preparing this Standard.
The data requirements that conform to the April 29, 1985, Section
3(c)(2)(B) Data Call—In Notice are not changed by this Standard.
The dates for submission of the required data under the Data
Call—In Notice re’main the same as stated in that Notice. The
toxicology data required by the Data Call-In Notice have been
received by the Agency and have been found adequate. However
6
-------
residue chemistry data for reduction of dietary exposure are
still outstanding under the April 29, 1985 Notice. This requirement
includes (1) Residue Reduction Data (section 171—4(c)) required on
certain agricultural commodities to establish the extent to which
residues from captan—treated crops may be reduced (see 3(a) below
for details), and must be submitted 12 months from the date
the registrants received the Notice, and (2) Crop Residue
Data as described in 3(d) herein must be sumitted 24 months from
the date the registrants received the Notice.
Based on a review and evaluation of all available data and
other relevant information on captan the Agency has made the
following determinations:
1. EPA has determined in a preliminary determination of
the Special Review of captan that pesticide products con-
taining captan for use on food crops do not meet the stat-
utory standard for registration under FIFRA and that, based
on available data, there are no modifications to the terms
and conditions of registration which would bring these
products into compliance with the statute. However, in
the final Special Review decision, EPA will retain any use
where data are submitted that demonstrate that actual residues
are sufficiently lower than current tolerances or that
modifications to application practices will sufficiently
reduce dietary risk.
Accordingly, EPA has proposed to cancel the registration
of each pesticide product containing captan and labeled
for use on any food crop, whether the product is registered
under section 3 or 24(c) of E’IFRA. However, if registrants
or other parties submit data showing that food residues are
sufficiently lower than EPA estimated or that alternative
application methods will sufficiently lower dietary
residues of captan, then EPA will consider continuing the
registrations of captart for use on food. EPA also proposed
to deny applications for Federal registration of captan
products for use on food crops.
EPA is requiring registrants to submit residue data to
support tolerances for the combined residues of captan
and its major metabolite, delta 4 —tetrahydrophthalimide
(THPI); and to determine actual residue levels before mak-
ing a final decision on cancellation of registrations of
products for this use. EPA also is requiring submission
of residue data to establish tolerances for seed treat-
ment, although it is not proposing to cancel registration
for use for seed treatment.
7
-------
EPA has also determined that the terms and conditions for
registration of pesticide products containing captan
for certain other uses must be amended in order to bring
these products into compliance with the statutory
standard.
Rationale: The principal concern about the risk posed by
captan is that its use on agricultural crops poses a risk
of cancer to humans through dietary exposure. EPA’s
concern is based primarily on the results of animal studies
showing statistically significant increases in the
incidences of gastrointestinal adenocarcinomas in male and
female mice and kidney tumors in male rats. EPA is also con-
cerned about the human health risks to persons applying
captan to crops, mixing or .loading formulations, working
in fields or nurseries with crops treated with the pesticide,
and mixing captan into end—use products such as mattresses,
shower curtains, and paints. Based on the oncogenic
potency demonstrated in animal studies and on estimates
of human exposure to captan, EPA has assessed lifetime
cancer risks from dietary and applicator exposure to
end—use captan products.
EPA has calculated lifetime oncogeriic risks for dietary,
worker and end—product exposure, based on human exposure
estimates and a potency factor derived from three studies.
Two studies conducted by Chevron in 1981 and 1983 showed
a statistically significant increase in adenocarcinomas
in the gastrointestinal tracts of male and female mice.
The results of a study con.ducted by Stauffer Chemical
Company showed a statistically significant increase in
kidney tumors in male rats. nalysis of the data from
these three chronic feeding studies show dose—related
increase in tumors.
If a pesticide is determined to be an oncogenic agent, it
is classified for regulatory purposes on the weight—of—
the—evidence, which involves consideration of the quality
and adequacy of the data and the kind of responses induced
by a potential oncogen (49 Federal Register, 46296—46297).
The evidence for determining captan’s oncogeriic class-
ification consists of: 1 ) an increased incidence in
uncommon adenomas and adenocarcinomas of the upper
gastrointestinal (GI) tract in the Charles River CD—i
strain of mouse in the two previously mentioned
8
-------
Chevron studies and one Stauffer study (1985), 2) an
increased incidence of these GI tumors in a National Cancer
Institute study using the B6C3F1 strain of mouse (1977), 3)
Captan is also associated with a small dose—related increased
incidence of kidney tumors in a second species, the Charles
River CD rat, 4 ) Captan shows positive mutagenic activity
in gene mutation and chromosomal aberration tests, in vitro ,
but not in vivo , 5) Other structurally related compounds
also demonstrate oncogen].c potential. Captafol (with the
same ring structure) is associated with a small treatment—
related increase in renal tumors in the Charles River CD
rat. Folpet (with the same side chain) is associated with
a treatment-related increased incidence of intestinal
tumors in the Charles River CD—i mouse.
On the basis of this information, the EPA has classified
captan as a “probable human carcinogen,” Group B2, under
EPA’s proposed guidelines (49 FR 46294).
Using the multistage model for a risk assessment of ca tan’s
oncogenic potential, the Agency has determined the for
5 sets of dose—to—tumor relationships. The geometric mean of
these 01 *S is 2.3 x IO 3 (mg/kg/dayY 1 . The values repre-
sent the upper 95% bound on the slope of the dose response.
Accurate residue data upon which EPA could base a
calculation of dietary risk estimates are not available.
ThereEore, EPA used the highest residue levels that are
legally permissible, the tolerance levels, as a basis for
its dietary risk estimates. Basing these estimates on the
tolerance levels is reasonable because the Food and Drug
Administration (FDA) monitors residue levels to ensure
that the tolerances are not exceeded and may seize any
foods with residues exceeding the tolerances. Thus, in
the absence of actual residue data, EPA is confident that
residues are no higher than the current tolerances. EPA
is requiring residue data from the registrants and will
include such data in calculating its final risk assessment
before taking final regulatory action. At this time,
however, EPA has calculated an upper bound estimate of
total dietary risk of iO to iO and is proposing
regulatory action on that basis. The quantitative
designation “io ”, i.e. 0.001, represents the upper 95
percent confidence limit on the probablity of developing
cancer as extrapolated from animal data. The actual
probability thus may be lower.
9
-------
In addition, these risks are based on worst—case assumptions
about dietary exposure (i.e., that food residues are at
current maximum allowable levels and that 100 percent of
the food crops are treated with captan). Data from market
basket surveys suggest that the exposure, and hence the
risk, may be substantially lower. Thus, the actual human
risks are probably lower than those estimated by EPA,
although definitive data are lacking to predict those lower
risks.
Use of captan on seeds may result in residues of captan
and/or its metabolites on the plants that grow from the
seeds; however, EPA has no data for plant residues from
seed treatment and no tolerances have been established.
While EPA is assuming at this time that the residues
would be insignificant due to the limited amount of
pesticide that can be transferred from the seed coating
to the whole plant, EPA is requesting such residue data
from the registrants before making a final determination
on the dietary risks to humans.
EPA has also quantified the oncogenic risk to agricultural
applicators, mixer/loaders, and fieldworkers, as well as
nonagricultural applicators and end users. Without
protective measures, the upper 95% bound estimates of risk tQ
agricultural applicators range from i0 to i0 for
dermal and inhalation exposure, while estimates for
mixer/loaders range from to i0 . Using expo-
sure data from studies on exposure from picking strawberries,
EPA’S upper 95% bound estimates of lifetime risk for field—
workers range from io 4 to i 6
For non—agricultural uses of captan, EPA’s assessment of
oncogenic risk for use in plastics, adhesives, paints,
and cosmetics ranges from negligible to significant. For
persons engaged in the manufacture of plastics, paints,
and cosmetics treated with captan, the potential risk
from exposure to captart is negligible if gloves, protective
clothing, and respirator (dust mask for .cosmetic
incorporation) are worn. For persons engaged in the
manufacture of captan—treated adhesives, the upper 95% bound
estimate of potential risk from captan incorporation is
if no protective clothing is worn. For end—
users of products containing captan, the upper 95% bound
estimates of risk range from for human exposure
to shampoos for animals to l0 for aerosol sprays if
no gloves are worn.
10
-------
In the preliminary Special Review determination, EPA considered
restrictions other than concellation of registrations that
would reduce the dietary risks posed by captan, as well as
exposure to applicators, mixer/loaders, fieldworkers, and product
end—users. Among the risk reduction measures short of cancel-
lation that are available to EPA are changes in the directions
for use on the pesticide’s labeling and classification of
the pesticide for “restricted use” pursuant to FIFRA section
3(d), EPA concluded that certain restrictions could be adequate
to reduce exposure and risks to an acceptable level for
applicators, mixer/loaders and fieldworkers, as well as for
most non—agricultural end—users. Such restrictions include
extending the preharvest interval and modifying application
practices, or prohibiting post—harvest application. However,
dietary exposure and residue data necessary to calculate any
reduction in dietary risks are unavailable, so that EPA cannot
consider these as viable options until such data are available.
EPA has encouraged interested persons to submit data on
alternative mechanisms for reducing dietary exposure to captan
and any data that would be used to refine the risk assessment.
It has been demonstrated that captan falls within Toxicity
Category IV (40 Code of Federal Regulations §162.10(h)(l))
based on oral toxicity, Toxicity Category III based on
inhalation toxicity, Toxicity Category I based on eye
irritation and is a dermal sensitizer. Captan has pro-
duced decreased pup litter weights in reproduction studies,
however it does not appear to be a teratogen for either
he rabbit or Golden Syrian hamster.
11
-------
2. The Agency has concluded that captart is not a teratogen in
hamsters.
EPA requested additional information (Federal Register,
Volume 50, P. 25886’). to determine whether captan was
teratogenic in hamsters. Adequate data has been submitted
and the Agency has concluded that the reported effect of
fused ribs in hamster was within normal background
incidence for the species.
3. The Agency has required certain residue chemistry data on
an expedited basis. This requirement was the subject
of a special Section 3(c)(2)(B) data call—in notice
dated April 29, 1985. This notice was sent to all
registrants of products that bear labeling for either
manufacturing or formulation use. The letter specified
the following data requirements:
As specified in the Pesticide Assessment Guidelines,
Subdivision 0, with sections indicated below, of the
Pesticide Data Requirements, part 158.125:
a. Residue Reduction Data
Section 171—4(c). Residue data are required for
the following agricultural commodities to establish the
extent to which residues from captan—treated crops may be
reduced. Depending on the commodity, data are needed on
residue levels present after washing, peeling, and/or
cooking (processing). These data are required under
section 171 .4(c)(2)(Iv)(b) for better estimation of
actual residues consumed. -
Samples may be fortified with captan at to1er nce
levels in the laboratory; field treated crop samples
are not required, but may be used if desired. Residues
of both captan and tetrahydrophthalimide (THPI) should be
analyzed before and after processing. Commodities marked
with an asterisk (*) should be fortified with captan and
THPI separately or together, with THPI fortified at one—
half the tolerance level of captan and analyzed before
and after cooking. The purpose of this study is to
determine whether captan and Ti-IPI residues are heat
labile.
12
-------
Processing/or
Washing Peeling Cooking
almonds x x
(blanching) (roasting)
apples, pears, quince (choose 1 ) x x x
*apricots, peaches (choose 1) x x x
avocados — x —
*beans, peas, (dry and succulent
including soy,
choose 2) x x x
(succulents) (shelling
dry beans)
beets, turnips, rutabagas (roots,
choose 2) x x x
blackberries, dewberries, rasp
berries (choose 1) x x
blueberries, cranberries
(choose 1) x x
broccoli, cauliflower (choose 1) x x
cabbage x — x
cantalopes, honeydews, muskmelon, — x —
watermelon (choose 2)
*Carrots x x x
celery x X
cherries, grapes,.plums (prunes), x x x
mangoes, nectarines (choose (large)
1 large, 1 small)
corn x x
(husking)
cucumbers, eggplant, summer
squash (choose 1) x x x
garlic, leek, onion, shallot
(choose 1 •dry, 1 green) x (green) x (dry) x
*grapefruit, lemon, lime,
orange, tangerine x (juice)
greens (beet, collard, kale,
mustard, turnip, spinach,
choose 2) x x
lettuce X
peppers (including pimientos,
choose 2) x x x
pineapple x x
*potatoes x x x
pumpkins, squash (choose 1) — x x
rhubarb x — x
*strawberries x x
taro x x x
tomatoes x x x
13
-------
b. Analytical_Methodolo_q
Section 171—4(b). In order to confirm the
market basket data already submitted, validation data for the
analytical methodology used by the registrants must be provided
as required under Section 171—4(b).
c. Feeding Studies
Sectron 171—4(c). Poultry feeding studies
are required because the data on eggs and tissues are lacking.
Eggs and tissues should be analyzed for parent compound
captan and its three metabolites tetrahydrophthalimide (THPI),
3—hydroxy THPI, and 5—hydroxy TI-IPI as required under Section
171—4(c)(3)(d). The highest feeding level should be equivalent
to 10 times the maximum level likely to be consumed by poultry.
d. Crop Residue Data
Section 171—4(c). Residue data for captan
and tetrahydrophthalimide are needed for all registered crops.
These data should be gathered in accordance with the Data
Requirements of 40 CER 158.125, with reference to the Pesticide
Assessment Guidelines, Subdivision 0, Section 171—4(c).
Specifically, the data should reflect the maximum total number
of applications (preplant, at—plant, preharvest, and post-
harvest, as registered), the maximum registered application
rate, minimum preharvest intervals, and be geographically
representative of the growing areas for each crop. Residue
levels must be reported separately for each stage of application
for which a crop is registered—-preplant, at—plant, preharvest,
and postharvest. For example, if a crop is registered for at—
plant and preplant use of captan, residue levels of captan and
THPI in the harvested crop must be measured and reported
separately. If a crop is registered for preplant, preharvest
and postharvest use of captan, the residues must also be
reported separately. Processing studies should be performed
where applicable with reference to 171—4(c)(2)(iv)(a). A
storage stability study should support harvest to analysis
Lntervals and storage conditions (e.g., temperature).
e. Seed Treatments
Section 171—4(c). The seed treatments using
captan were registered as nonfood uses. The Agency has since
determined that, unless radiolabeled studies showing no uptake
are provided, seed treatments are food uses, and normally require
low—level (method sensitivity) tolerances. Because captan is
used to treat seed from a number of commodities not having
14
-------
established tolerances and since no tolerances have yet been
proposed to cover the possible residues from seed treatments,
EPA requires residues data for captan and THPI for representative
crops to support low level tolerances covering seed treatments.
Residue data for crops grown from treated seed must be submitted
for corn, soybeans. rice or a small grain, potatoes, and two of
the vegetables having seed treatments. Assuming that detectable
residues are not found in these crops, the residue data from
these six crops can be translated to other crops in support of
additional tolerances for seed treatments. If detectable
residues are found, then data for additional crops may be
required, depending on the level observed.
Rationale: The Agency is concerned about captart’s oncogenic
potential and needs the data mentioned above to complete the
Special Review. In addition, the data are inadequate to support
registration of seed, seed—piece and other plant propagule
uses as non—food and non—feed uses. Data requirements to
support these uses are listed in Tables A and B.
4 . The available environmental fate data are insufficient to
fully assess the potential for exposure of humans and non—
target organisms to captan. When the required studies
under §158.130 are submitted, a complete environmental
exposure assessment can be made.
An interim 4—day reentry interval has been imposed for
the agricultural uses of captari until adequate data have
been submitted as specified in Table A, Section 158 .140,
Subdivision K, Re—entry.
15
-------
Rationale: Captan meets the chronic (oncogenic effects in
mice and rats) and use-pattern (application to growing crops)
criteria of 40 CFR 58.140 for submission of reentry
exposure data. Fieldworker exposure data are available
for strawberry harvesters but not for other crop harvesters;
the data were summarized in the Captan Position gocument 2/3.
Table 22 of that document estimates risks of l0 to io6 (B 2 )
for picking-and weeding strawberries under tile assumption
of a 35—year working lifetime. As this captari registration
standard proposes not to reregister captan for food uses,
the period of exposure for which an interim reentry
interval will be in effect is likely to be about three
years (the time necessary to complete a cancellation
action). Therefore the estimated risk to fieldworkers
is roughly an order of magnitude lower. The exposure data
on which this risk assessment was based (Table 13 of
the PD 2/3) were generated from seven field exposure
studies, four of which were carried out while strawberries
were being harvested three to four days after captan
application (the other three studies involved longer periods
after application). The Agency has accordingly decided
to set an interim reentry interval of four days for captan
to prevent workers from reentering treated fields with—
out protective clothing. Reentry is permissible during this
time provided that appropriate protective clothing is worn.
Registrants are required to submit reentry data for
captan in accordance with 40 CFR 158.140. When data are
submitted, the Agency will reevaluate this restriction.
5. In order to evaluate Captan’s potential to contaminate
ground water the Agency is requiring the following
studies:
158.130 Environmental Fate
161—1 Hydrolysis
161—2 Photodegradatiori in water
161—3 Photodegradation on soil
162—1 Aerobic Soil Metabolism
162—2 Anaerobic Soil Metabolism
162r3 Anaerobic Aquatic Metabolism
163—1 Leaching and Adsorption/Desorption
164—1 Soil Dissipation
158.120 Product Chemistry
63.8 Solubility
63.11 Octanol/ water Partition Coefficient
16
-------
Rationale: There are inadequate data to conclude that
captan does not pose a ground water problem due to potential
leaching of metabolites and/or degradates. The Agency
is concerned about surface water and possible ground water
contamination by captan and its degradates. Metabolites and
degradates in soil have not been adeqately studied. There-
fore, mobility studies and the fate of the metabolites and
degratates are required. In order to characterize the
potential for captan to enter ground water, the Agency
needs the studies mentioned above.
6. Acute toxicity studies on estuarine and marine organisms
and simulated or actual field testing with aquatic
organisms are required under this Standard. Data from
fish early life stage studies, aquatic invertebrate life
cycle studies, aquatic organisms accumulation and simulated
or actual field testing with aquatic organisms may be
required pending results from environmental fate studies.
Both the needed environmental fate data and the above
mentioned data are to be submitted on an expedited basis.
Protocols addressing the simulated or actual field studies
must be submitted for approval by the Agency prior to
conducting the studies.
Rationale: The Agency is concerned about the fish toxicity
and toxic effects to estuarine and marine organisms
because captan is very highly toxic to fish. The
available environmental fate data are insufficient to fully
assess the poterit.ial for exposure of nontarget organisms to
captan. When the required studies under 40 CFR §158.130
are submitted, a complete environmental exposure assessment
can be made for accumulation in fish.
There are insufficient data to characterize the acute and
chronic toxic effects of captan on aquatic invertebrates.
Toxicity data are needed for assessing the hazards to
aquatic invertebrates. Use of captan as a seed treatment
for rice and as a foliar application to citrus and
cranberries may create art acute hazard for nontarget fish
and aquatic invertebrates. Use on citrus may result in
a hazard to two endangered bird species by reducing their
food supply. Everglade Kites consume apple snails and
Wood Storks consume fish. Both the apple snail and fish
populations may be critically reduced by exposure to
captan and its degradates. The ecological effects and expo-
sure assessment data bases are insufficient to preclude
exposure to such risks. Therefore, simulated and/or
actual field studies to quantify such risks are required.
17
-------
7. In order to meet statutory standards product labeling
must be revised to include a requirement to use pro-
tective clothing. In addition, all end—use products
intended for crop use, except seed uses and plant
propagule treatments, must bear labeling restrictions for
crop rotation and for reentering treated areas. (Refer
to Section F, Required Labeling).
Rationale: To reduce risk from captan’s oncogenic
potential and its toxicity to fish, and to maintain
existing registrations, registrants must revise product
labeling as specified in Section F of this Standard.
8. Manufacturing—use pesticide products containing captan as
a sole active ingredient may be registered for sale,
distribution, reformulation, and use, subject to the
terms and conditions specified in this Standard.
Registrants must provide or agree to develop additional
data, as specified in the tables, in order to maintain
existing registrations or to permit new captan registrations.
Rationale: Under FIFRA, the Agency may elect not to cancel
or withhold registration even though data are missing or
inadequate (see Section 3(c)(2)(B) and 3(c)(7) of FIFRA).
Rather, issuance of th.is Standard provides a mechanism
for identifying data needs and sets a timetable for
generation of needed data. These data will be reviewed
and evaluated when they are received and the i gency will
determine at that time if they will affect the registration
of captan products.
9. The Agency has reevaluated the use of detreated seed
corn for feed use for cattle and hogs, since stating
(Federal Register, Vol. 50, p 25888, June 21, 1985)
that the practice of using detreated seed corn for
feeding of cattle and hogs may be continued as long
as the seed.is washed to reduce captan below a 100
parts per million (ppm) tolerance level and the seed is
used only for feeding of cattle and hogs up to 14
days prior to slaughter. The Agency expects to take
action to revoke the tolerance regulations that permit
the use of detreated seed corn within one year from
the date this Standard is received by the American
Seed Trade Association, who originially requested that
these tolerances be established (EPA PP No. 3E1367 and
EPA FAP No. 3E1367), if the following concerns are not
resolved:
18
-------
a. Residue chemistry data must be submitted for
detreated corn seed that had been treated at the
maximum labeled dosage of 3.21 oz. of active
ingredient captan per 100 lbs. of corn seed, the
data should be from such seed that had been in
storage for 3, 6, 12 and 18 months. It is assumed
that samples of such captan treated seed may
be found in commerce. If there is a question
as to the history of the samples used, then a
study must be instituted and conducted to assure
that the data are acceptable. In any regard,
studies with samples from commerce must be
submitted within the time frame stated above.
b. An acceptable method for informing corn seed treaters
and corn seed distributors of acceptable methods
for detreating captan treated corn seed must be
proposed.
c. An acceptable handling procedure for captan treated
seed corn (to be detreated) to assure that there
are no other pesticides on the seed must be proposed.
Rationale: The regulations for residues of captan in detreated
seed corn (21 CFR 561.65) and for residues of captan in fat,
meat and meat byproducts of cattle and hogs (40 CFR 180 .103)
do not identify permitted methods for detreating the captan
treated corn seed. The Federal Register Notice (46 FR 55091—
55092) which established the regulation (21 CFR 561 .65)
mentions washing and roasting, thereby implying that these are
acceptable methods. The Agency has inadequate data to support
either washing or roasting when the maximum registered dosage
of 3.21 oz of captan per 1 0 lbs of seed had been applied.
The Agency now has data to show that captan metabolites occur
in milk and meat. The tolerances for negligible residues
of 0.05 ppm in fat and meat and meat byproducts of cattle and
hogs was established (46 FR 55113—55114) without identifying
the metabolites that occur in animal tissues. A review of
the record shows that there were no acceptable residue data
to support the roasting detreatment method at any dosage
or period of storage. The data deficiencies for residues
of captan in food is covered in Section G and Table A of
this Standard.
19
-------
D. CRITERIA FOR REGISTRATION UNDER THIS STANDARD
All products that contain captan as the sole active ingredient
are subject to this standard and must bear required labeling and
either comply with the acute toxicity limits, product composition,
and use patterns requirements listed in Section E of this document,
or submit data and a justification to amend the standard to
encompass such products.
E. ACCEPTABLE RANGES AND LIMITS
1 . Product Composition Standard
Technical grade products must contain at. least 87 percent
captan and 5 percent related derivatives as the active
ingredients. Each manufacturing—use product must be
fully described with an appropriate certification of
limits. In addition, the active ingredient found in the
manufacturing—use capt.an products must be substantially
similar to that in the currently registered technical
product. Any manufacturing—use product not meeting these
requirements will be considered a new product and will
require an amendment to the standard.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade
and manufacturing—use products containing captan for
acute toxicity category I, provided that the labeling of
those products bear appropriate precautionary statements.
3 . Use Patterns
To be registered under this Standard, manufacturing—use
products containing captan may be labeled for formulation
only into end—use products for use as a fungicide for
foliar applications to fruit, nut, vegetable, and
ornamental crops, for application to seeds and plant
propagules, as a preplant application to soil, as post—
harvest application to fruit and vegetable crops, and for
application to produce packing boxes, to soil and crops
grown in greenhouses, to house plants, to home gardens,
to dog and cat dusts and shampoos and to hand soaps.
Captan may be labeled for incorporation into plastics, oil—
20
-------
base paints, wall paper pastes, textiles, paper, and
cosmetics. It may be registered either in single active
ingredient formulations or in combination with other
fungicides and with insecticides.
4 . Labeling of New and Existing Stock of Registered Products
All captan product registrations must be amended to reflect
the required labeling as specified under Section F (which
follows) within six months after the date of this Standard.
Existing stocks of all captan products in the channels of
trade after one year must bear the required labeling as
specified under Section F.
F. REQUIRED LABELING
ku technical grade and manufacturing—use products (MUP5) and
end-use products (EUPs) must bear appropriate labeling as
specified below and in 40 CFR §162.10. Other portions of
this guidance package contain specific information regarding
labeling requirements. Required labeling must be submitted
within 90 days from the date of receipt of this Standard.
I . Ingredient Statement
The labeling ingredient statement for MUP5 and EUPs must
identify the active ingredient as:
Active Ingredients By Wt.
*Captan
RelatedDerivatives
Inert Ingredients
*N_Trlchloromethy lth io—4—cyc lohexene—1 , 2—
dicarboximide -
2. Precautionary Statements :
All products, MUP5 and EUPs, must bear the following
labeling precautionary statements:
“DANGER
Causes irreversible eye damage. Harmful if swallowed or
inhaled. May cause allergic skin reactions. Do not get
in eyes. Wear goggles or face shield when handling.
Avoid contact with skin and clothing. Remove and separately
launder clothing before reuse.”
21
-------
3. Environmental Hazards Statements
Manufacturi ng—tJse Product Statements
“The product is toxic to fish. Do not discharge
effluent containing this product into lakes, streams,
ponds, estuaries, oceans or public water unless this
product is specifically identified and addressed in an
NPDES permit. Do not disch-arge effluent containing this
product to sewer systems without previously notitying the
sewage treatment plant authority. For guidance contact
your State Water Board or Regional OEfice of the EPA.”
End—Use Product Statements
a. All EUPs that allow foliar application must bear the
hazard precaution (which does not apply to cranberry
and taro uses on EUP labels):
“This pesticide is toxic to fish. Do not apply
directly to water or wetlands (swamps, bogs, marshes
and potholes). Drift and runoff from treated areas
may be hazardous to aquatic organisms in neighbor-
ing areas. Do not contaminate water by cleaning
of equipment or disposal of wastes.”
b. In addition to the above statement, all EUPs that
bear claims for foliar applications to cranberries
and taro must include the following environmental hazard
precautions as part of the use directions for cran-
berries and taro:
“This pesticide is toxic to fish. Drift nd
runoff from treated areas may be hazardous to
aquatic organisms in neighboring areas. Do not
contaminate water by cleaning of equipment or disposal
of wastes.”
C. All EUPs that allow seed treatment must bear the
following environmental hazard precaution:
“This pesticide .is toxic to fish. Do not contaminate
water by cleaning of equipment or disposal of wastes
In the event that treated seeds are spilled and can-
not be salvaged, completely cover them with soil.”
d. Endangered Species Precautions
(Additional precautionary labeling may be required
pending results from the information submitted in
response to the required environmental chemistry and
22
-------
ecological effects data. The total potential risk to
endangered species cannot be evaluated on the basis
of the limited data presently available to EPA.)
The following precautions must be added to EUPs that
bear claims for outdoor uses when the product is
distributed in the States of Alabama, New Mexico,
Tennessee, Texas, and Virginia:
\ “It is a violation of Federal laws to use any
pesticide in a manner that results either in the
death of an endangered species or adverse modifica-
tion of its 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:
STATE COUNTY
Spec i e S
(BULLETIN NO.)
ALABAMA Lauderdale
Slackwater Darter Limestone
(EPA/ES—85—05) Madison
NEW MEXICO Chaves
Peco gambusia Eddy
(EPA/ES—85—21
TENNESSEE Lawrence
Sl ckwater Darter Wayne
(EPA/Es—85—04
Freshwater Mussels Hancock
(EPA/ES—85—07) Cia iborne
Hawkins
Sullivan
TEXAS Reeves
Pecos gumbusia Jeff Davis
(EPA/ES—85—20) Pecos
Commanche Springs Pupfish Reeves
(EPA/ES—85—22) Jeff Davis
VIRGINIA Smyth
Freshwater Mussels Scott
(EPA/ES—85—06) Lee
Washington
Gray son
23
-------
Before using this product in the above counties you must obtain the
EPA Bulletin specified 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 from either your County Agricultural Extension Agent, the
Endangered Species Specialist in your State Wildlife Agency Head-
quarters or the Regional Office of the U.S. Fish and Wildlife Service.
THIS BULLETIN MUST BE REVIEWED PRIOR TO PESTICIDE USE . Call
1—800—000—0000, toll free, if you have any questions •or cannot
obtain the appropriate bulletin.”
4 . Use Precaution Statements
a. The following statements are to be added under the labeling section,
“Direction for Use”, as specified:
For All EUPs That Claim Agricultural Uses :
“Mixers, loaders and applicators, when mixing, loading and applying
must wear mid—forearm to elbow length natural or synthetic rubber,
vinyl or plastic gloves impermeable to captan, boots or
overshoes, one piece overalls which has long sleeves and long
pants, face shield or goggles, and a hat or other appropriate
head covering.”
“Fieldworkers and harvesters must wear natural or synthetic
rubber, vinyl, or plastic gloves impermeable to captan
residues. Leather or fabric gloves are not acceptable. t ’
If the product is a liquid, the following statement must be added:
A chemical resistant apron must be worn when mixing and
loading this product.”
If the product is a dust, granular or wettable powder the followin
statement must be added:
“A dust mask must be worn when mixing and loading this product.”
For all products:
“Clothing worn while loading, mixing and applying this product
must be laundered separately from other clothing before reuse.
Clothing that may have been drenched or heavily contaminated must
be disposed of in accordance with state and local regulations.”
24
-------
For All EUPs
The following precaution may be added:
“Applicator’s protection may also be obtained by use of an
enclosed tractor cab with a properly filtered air supply.”
For All EUP5 That Claim Homeowner Uses (Yards and Gardens,
House Plants, Shampoos, etc.) :
“Wear natural or synthetic rubber, vinyl, or plastic gloves
impermeable to captan when using indoors or outdoors.
When using outdoors wear long pants and long sleeved shirt
and apply with the wind to your back. Wash nondisposable
gloves thoroughly with soap and water before removing.
Clothing worn while handling this product must be
laundered separately from other clothing before reusing.”
h. All EUPs intended for crop use, except seed, seed piece, and
plant propagule treatements must bear the following use
restrict ions:
i. Do not rotate a foliar treated crop with crops other than
those with registered captan uses.
ii. Do not allow persons to enter treated areas within 4 days
following application unless protective clothing is worn.
Conspicuously post reentry information at site of
application.
lii. Water from cranberry bogs and wetland taro fields (in which
either cranberry plants or taro plants had been treated with
captan) must not be used for irrigation of crops other than
those with registered captan uses.
c. For EUPs that bear labeling for use in greenhouses the following
statements must be added:
“Only the applicator is permitted to be in the greenhouse
during application of captan to soil. Open vents to
greenhouse during application and at least for 1 hour
after application.”
“Workers planting in captan treated soil in greenhouses
must wear gloves impermeable to captan.”
25
-------
C. Tolerance Reassessment
1 . Non—Seed Applications
The established tolerances for captan are presently
expressed as the fungicide captan (N—trichloromethylthio—4—
cyclohexane—1 ,2—dicarboximide) without specifying the metabolites.
The following metabolites have been identified in plants:
delta 4 —tetrahydrophthalimide (THPI,II),
delta 4 —tetrahydrophthalamic acid (TUPAM, III),
4 ,5—epoxyhexahydrophthalimide (THPI—epoxide, V) 1
3—hydroxy—delta 4 —tetrahydrophthalimide (3—OH TUPI, VI),
5—hydroxy—delta 3 —tetrahydrophthalimide (5—OH THPI, VII),
and N—(trichloromethylthio)—4 ,5—epoxyhexahydrophthalimicje
(captan—epoxide, IV).
The major residues are the parent, TI-IPI, and TI-IPAM; the minor
residues are THPI—epoxide, captan epoxide, and 3— and 5—OH THPI.
The following rnetabolites have been identified in
tissues, organs, and milk of goats:
delta 4 —tetrahydrophthaljrnjde (THPI, II),
4 ,5—epoxyhexahydrophthalimide (THPI—epoxide, V),
3—hydroxydelta 4 —tetrahydrophthalimide (3—OH THPI, VI),
5—hydroxydelta 3 —tetrahydrophthalimide (5—OH THPI, VII),
and 4 ,5—dihydroxyhexahydrophthalimicje (4,5—di—Ol-! HHPI, IX),
delta 4 —tetrahydrophthalamic acid
(TI-IPAM, III) and phthalirnide (P1, X) have been identified
as minor metabolites in milk (III), tissues (X), and organs
(X).
The following table identifies the structures at
captan and its metabolites with identifying codes and abbreviations.
26
-------
Captan and its rnetabo1ites
CODE STRUCTURE CHEMICAL NAME ABBREVIATION
0
N.(trich1or 1ethy1thiO)cyClohex -4—efle.1 .2— Captan
I NSCCI3 dicarboximide
II 1JTNH THPI
COOH
In I 4 -Tetrahydrophtha1amic acid THPAM
CONH2
IV O NSCCI3 N.(tr,chIoromethy1thio)-4,S-epoxyhexahyd phthdl1m1de Captan-epoxide
O NH 4,S-Epoxyhexahydrophthdl lmide THPI-epox ide
3.Hydroxy— 4 - tetrahydrophthal irnide
0
VII
0
COOH
VI II IXCOCH
HO
NH
HO
0 o
111J:NH Phtflallmlde
0
, ‘ CO0H
XI II 1
‘ r’ ’C0NH2
OH
S—Hydroxy—4 3 -tetrahydroPhthal imide
4 -Tetranydrophtha1 ic acid
4,5—Dlhydroxyhexahydrophthal m1de
3-Hydroxy—4 4 - tetrahydrvphthalamlc acid
3—OH THPI
5—OH TNPI
THPAL
4 .5-diON HHPI
P1
3-OH IHPAM
‘ As there have been no studies in ici t’ e trichlorot-ethvl side chain has been
radiolabelled, the tate of this si- e chain is not understood.
27
VI
-------
The following table lists the present tolerances
in parts per million for residues of captan.
Parts
Per
Million
in
Captan
Residues
Raw Agricultural Commodity U.S.
Canada
Mexico
Codex
ALMOND, HULLS
ALMONDS 2.01 - — -
APPLES 25.0** 5.0 25.0 25.0
APRICOTS 50 .0 5 .0 — 20 .0
AVOCADOS 25.0 - - -
BEANS, DRY 25.01 — 25.0 —
BEANS, SUCCULENT 25.01 — 25.0 10.0
BEETS, GREENS 100.0 — —
BEETS, ROOTS 2.0
BLACKBERRIES 25.0 - -
BLUEBERRIES (HUCKLEBERRIES) 25.0 5.0 — 20.0
BROCCOLI 2.0 - 2.0 —
BRUSSh LS SPROUTS 2.0 —
CABBAGE 2.0 2.0
CANTALOUPS 25.0 25.0
CARROTS 2.0 2.0
CATTLE, FAT 0 .0 5
CATTLE, MBYP 0 .05
CATTLE, MEAT 0.05 —
CAULIFLOWER 2.0 2.0
CELERY 50 .0 — 50 .0 —
CHERRIES 100.0 5.0 — 50.0
COLLARDS 2 .0 - — -
CORN, SWEET (K+CWHR) 2.0 2.0
COTTON, SEED 2.0 - 2.0 —
CRABAPPLES 25.0 5.0 25.0 25.0
CRANBERRIES 25.0 5.0 — 10.0
CUCUMBERS 25.0 — 25.0 10.0
DEWBERRIES 25.0 — -
EGGPLANT 25.0 —
GARLIC 25.0 25.0 —
GRAPEFRUIT 25.01 — — 15.0
GRAPES 50 .0 5 .0 —
HOGS, FAT 0.05 - —
HOGS, MBYP 0.05
HOGS, MEAT 0.05 -
HONEYDEW Melons 25.0 25.0
KALE 2.0 —
28
-------
Continued
Raw Agricultural Commodity
Parts Per
U.S.
Million in Captan Residues
Canada Mexico Codex
LEEKS
LEMONS
LETTUCE
LIMES
MA NGO ES
MUS KMELONS
MUSTARD, GREENS
NECTARI NES
ONIONS, DRY BULB
ONIONS, GREEN
ORANGES
PEACH ES
PEARS
PEAS, DRY
PEAS, SUCCULENT
PEPPERS
PIMENTOS
PINEAPPLES
PLUMS (F’RESH PRUNES)
POTATOES
PUMPKINS
• Q U I NC ES
RAS PBERRI ES
RHUBARB
RUTABAGAS, ROOTS
SHALLOTS
SOYBEANS, DRY
SOYBEANS, SUCCULENT
SPINACH
SQUASH, SUMMER
SQUASH, WINTER
STRAWBERRI ES
TANG ERI NES
TARO (CORN)
TOMATOES
TURNIPS, GREENS
TURNIPS, ROOTS
WATERMELONS
50 .0
25.01
100 .0
25.01
N. 50 .0
‘ 25.0
2 .0
50 .0
25.0
50 .0
25.01
50 .0
25.0
2 .0
2 .0
25.0
25.0
25.01
100
25.01
25.0
25.0
25.0
25.0
2 .0
50 .0
2 .0
2 .0
100 .0
25.0
25.0
25.0
25.01
0.25
25.0
2 .0
2 .0
25.0
25.0
50 .0
40 .0
25.0
2 .0
2 .0
2 .0
10 .0
10 .0
15.0
20 .0
1 5 .0
— 2.0 —
— 100.0 .20.0
*1 Interim tolerance pending evaluation of captan under Rebuttable
Presumption Against Registration (RPAR) review on transfer of
residues to meat, milk, and eggs from feeding the raw agricultural
commodity or their byproducts.
** Established tolerance under regulatipn, Section 180 .103, 40 CFR.
— 100.0
— 50.0
— 25.0
1 5 .0
10.0
1 5 .0
1 5.0
1 5 .0
25.0
5 .0
5 .0
5 .0
5.0
25.0
2 .0
5 .0
5 .0
25.0 20.0
— 15.0
— 15.0
25.0
29
-------
The following table lists requests for captan
tolerance actions presently before the Agency.
Proposed
Parts Pe
r
Million
inCaptan
Residues
EPA Pestici
de
Raw
Agricultural Commodity
Petition
U.S.
Canada
Mexico
Codex
Number
Almond Nutmeats
Dill
3F2898
9E2251
1 .0
2.0
—
—
—
—
—
—
Kiwi Fruit
0E2427
1
.0 or 10
.0
—
—
20.0
Parsley
9E225 0
100 .0
—
—
-
Taro Leaves
7E1982
0.25
-
—
-
A feed additive regulation ( 561.65, Title 21,
Code of Federal Regulations; Parts 500 to 599) permits
residues of captan at 100 .0 ppm remaining on corn seed from
its intended use as a seed protectarit after detreatmerit.
Detreated corn seed can be used only as a feed for cattle
and hogs up to 14 days prior to slaughter.
The Federal Register Notice of Intent to Cancel Registration of
Pesticide Products Containing Captan; Availability of Position
Document 2/3 (FR, Vol. 50, page 25888) stated: “the practice
of using detreated corn seed for feeding to animals may be
continued as long as the seed is washed to reduce captari to a
100 ppm tolerance level.” This Notice did not address the use
of unwashed corn seed that had been detreated by roasting. To
permit detreating by roasting the Agency is requiring data on
the chemical fate of captari pyrolysis products and other
other pesticides that may be present on seed corn.
A food additive regulation ( l93.4O, Title 21,
Code of Federal Regulations Parts 170 to 199) permits 50.0 ppm
residues of captan in or on washed raisins when present as a
result of fungicidal treatment by preharvest application to
grapes and postharvest application during the drying process.
2. Seed Applications
No tolerances have been established for captan
residues in or on any crop commodity for which captan is
registered solely for seed or plant propagule application,
because heretofore seed or plant propagule applications were
considered as nonfood uses. The EPA registered seed and plant
propagule uses that have been considered as nonfood uses include:
alfalfa, asparagus (plant propagule), barley, beans, beans
(lima), beets (sugar), beets (table), bluegrass, broccoli,
brussels sprouts, cabbage, cantaloupe, carrots, cauliflower,
30
-------
clover, collards, corn (field), corn (sweet), cotton, cowpeas,
crucifers, cucumbers, eggplants, flax, grasses, kale, legumes
(small seeded), lentils, lespedeza, millet, milo, muskmelon,
mustard, oats, onions (pelleting), peanuts (shelled and unshelled),
peas, peppers, pineapple (plant propagule), potato (plant
propagule), pumpkins, radish, rice, rutabaga, rye, safflower,
sesame, sorghum, soybeans, spinach, squash, sugar beets, sun-
flower, swiss chard, tomatoes, trefoil, turnip, watermelons,
and wheat.
3. Plant Metabolism
Available plant metabolism data are not completely
adequate for identifying the metabolites that may result
from the maximum uses and necessary to support the established
tolerances. Quantification and identification of captan
and certain metabolites were performed only for apples
(following foliar or postharvest treatment) and oranges
(postharvest treatment). As captan and captafol have common
rnetabolites in plants, metabolism of captafol in tomatoes
and corn were compared and evaluated with the apple and oranges
metabolism studies. The studies in these plants were adequate;
however, certain additional studies identified in Table A,
Generic Data Requirements for Captan, §158.125, Residue Chemistry,
are required to clarify the nature of residues of captan in
plants.
Future tolerances and existing tolerances may
require inclusion of certain metabolites in the expression of
tolerance, depending on the results from the required potato and
lettuce metabolism studies. In a Special Data Call—In Notice on
Captari dated April 29, 1985, the Agency requested residue data for
captan and THPI for all registered crops.
4 . Animal Metabolism
Available animal metabolism data are not adequate
to support the tolerances in meat; and to establish tolerances
in milk and poultry and eggs. Adequate data are available to
identify and quantify metabolisrr of the ring portion of the
captan molecule, but no data are available on the metabolism of
the trichloromsthylthio moiety (side chain). Certain additional
studies identified in Table A, Generic Data Requirements for Captan,
§158.125 Residue Chemistry, are required to clarify the nature
of residues of captari in animals.
Future tolerances and existing tolerances in meat,
fat, and meat byproducts thay require inclusion of certain
metabolites in the expression of the tolerance, depending on the
results from the required animal feeding studies. In a special
Data Call—In Notice on Captan dated April 29, 1985, the Agency
requested feeding studies and analyses for captan se,
THPI, 3—ON THPI, and 5—ON TUPI.
31
-------
5. Analytical Methods for Residues
Adequate gas chromatography (GC) and colorimetric
methods are available for identifying and quantifying residues of
captan in animal and plant commodities, with the exception of
colorimetric methods which specify surface stripping rather than
grinding or homogenating plant samples. Surface stripping is
ac ceptab1e for samples treated postharvest only and analyzed shortly
after treatment. Field treated samples must be ground or homogenized
as part of the extraction procedure.
For enforcement purposes, FDA ’s Pesticide Analytical
Manual, Method I, Vol. II, Pesticide Regulation Section 180 .103
is acceptable for plant commodities. No validated method is
available for enforcement of tolerances for residues of captan
in animal commodities. Validation of a GC method given in MRID
00025123 must be completed. Validation of GC methods for
determining delta 4 —tetrahydrophthalimide (THPI, [ I) in plants
and THPI and 3—hydroxy—delta 4 —tetrahydrophthalimide (3—OH THPI,
VI) in milk, eggs, animal tissue, and 5—hydroxy—delt.a 3 —tetrahy—
drophthalimide (5—OH TI-iPI, VII) in milk must be validated by
method tryout. The GC method given in MRID 00045179 which
determines delta 4 —tetrahydrophthalarnic acid (TI-IPAM, III) in
animal tissues must also be validated.
As the nature of residues in both plants and
animals have not been adequately described, additional metabo—
lites of concern may have to be identified and quantified.
Method for analysis must be submitted and validated for such
residues.
Data on analytical methods for identifying and
quantifying residues in plants and animal tissue are specified
in Table A, Generic Data Requirements for Captan, §158.125.
6. Storage Stability
No data are available on the storage stability of
residues of captan in animal commodities or in or on plant
commodities. As the nature of residues in plants and animals
has not been adequately described, if additional metabolites of
concern are found, data on the storage stability of such residues
in storage will be required.
The storage stability data required under this
Standard is described in Table A, Generic Data Requirements
for Captan, §158.125.
32
-------
7. Amended Tolerances Needed to Allow Continued
Registration of Uses :
a. Food Uses Registered with Established Tolerances
Under a California Special-\Local Needs
registration (SLN No. CA780027) asparagus may be seed treated
or root dipped. Under a Washington Special Local Needs
registration (SLN No. WA800035) kohirabi may be seed treated or
soil treated. No tolerances exist for captan residues in
eLther of the commodities. Tolerances must be proposed in a
tequest for an EPA Pesticide Petition to cover the residues of
captan that may occur in these commodities. Alternatively,
these registered uses must be withdrawn by the States.
There are registered uses of captan treatment
of soil for greenhouse benches in which vegetables are grown. The
use—patterns involving these use sites should specify for use
only with vegetables having tolerances for residues of captan.
b. Use as a Seed Treatment
Heretofore, seed treatments and plant propagule
treatments have been considered nonfood uses. Availa le plant
metabolism data (refer to Nature of the Residue in Plants
section) indicate that residues of captan may be taken up into
mature plants from treated seed. Therefore, seed treatments
are uses for which residue data and requests for EPA Pesticide
Petitions for proposed tolerances must be submitted. The nature
of residues in plants is not adequately understood. If the
required plant metabolism data indicate additional rnetabolites
of concern, additional residue data and tolerance proposals for
the metabolites will be required.
c. Need for Processing Studies
Processing studies are required for the
following commodities.: potatoes, beans, soybeans, tomatoes,
oranges, plums, sweet corn, and cottonseed.
33
-------
d. Tolerance Reductions Under Review
An EPA Pesticide Petition (No. 3F2898)
proposing reduction of tolerances for the residues of captan
in the following raw agricultural commodities: almonds, apricots,
beans (dry and succulent), beet greens, blackberries, blueberries,
cantaloupe, celery, cherries, cranberries, cucumbers, dewberries,
grapefruit, grapes, honeydew, lemons, lettuce, limes, muskmelon,
nectarines, oranges, peaches, peppers, plums, jnpkins, rasp-
berries, rhubarb, spinach, squash (summer and winter), straw-
berries, tangerines, tomatoes, watermelon, and washed raisins
is pending with the Agency. The amendment also requests that
the expression of residues include delta 4 —tetrahydrophthalimide.
e. Amendment Required for Established Tolerances
The following amendment to Section 180 .103
for residue tolerances for captan are required: (i) “beets
(roots)” in the regulation should be changed to “garden beets,”
the appropriate definition for this commodity; (ii) “taro
(corn)” in the regulation should he changed to “taro root,” the
appropriate definition for this commodity; (iii) tolerances for
residues in or on garlic, leeks, and shallots should he cancelled,
since there are no registered uses of captan n these crops;
(iv) “soybeans, succulent” and “soybeans, dry” should be deleted
from the regulation and “soybean seed” should be added, since
“seed” is the appropriate definition for this raw a ricultural
cornmoditiy; (v) tolerance proposals accompanied by residue data
or feeding and grazing restrictions must be proposed for bean
and pea vines and hay, and soybean forage, hay, and straw; (vi)
“muskmelon” and “honeydew melon” should be deleted from the
regulation since “cantaloupes” covers these commodities; (vii)
“tangelos” should he deleted from the regulation because
“tangerines” covers this commodity; (viii) in 1969 (P pril 12, 1969),
34 FR 6442 revised the 100 ppm plum tolerance to 50 ppm but
this change was never incorporated into the regulation. This
revision should be made; (ix) on receipt of the data requested
for grapes, appropriate food/feed additive tolerances must be
proposed for residues in Juice and raisin waste; (x) the
tolerance for residues in or on crabapples should be deleted
from the regulation as no .registered use for captan on this
commodity exists; and (xi) tolerance proposals and residue data
or feeding and grazing restrictions are needed for pineapple
and cottonseed forage.
f. Label Restrictions Required
Captan may be used as a component of paper
and paper board that may come in contact with aqueous and
fatty foods [ 21 CE’R 176.170(c)]. Residue data to support this
34
-------
regulation are required to support the EPA registered use—
pattern. Alternatively, label amendments are required to restrict
the use of captart—treated packing boxes for fruits and vegetables
having tolerances for residues of captan.
The theoretical maximum residue contri-
bution (TMRC) . rom established tolerances is 12 mg/day based
on a 1 .5 kg diet. The changes in the residue definition, the
tolerance proposals, and the pending tolerances noted above will
all affect a change in the TMRC level. The data requirements
to support established tolerances as listed in 40 CFR 180 .103
are given in Table A.
The Provisional Maximum Permissible Intake
(PN1PI) for a 60 kg person is 0.75 mg/day based on a Provis-
ional Acceptable Daily Intake (PADI) of 0.0125 mg/kg. The
present TMRC represents 1600 percent of the PMPI. The
inclusion of the major metabolite (THPI) in the tolerance
expression may result in an increase in the TMRC and a
greater percentage of the PMPE utilized.
The PADI for captan is based on a rep’roductive
toxicity study in rats. A no—observed—effect level (NOEL) was
established at 1.2.5 mg/kg/day for decreased pup weights.
A safety factor of 1000 is used to derive the PADI because
there was only chronic data on one species. The PADI will be
changed to an ADI when chronic data on a second species (norirodent)
are submitted and found adequate. The data from the most
sensitive species and a safety factor of 100 will be used.
The’ NOEL of 12.5 mg/kg/day was based on reproductive toxicity
excluding the issue of oricogenicity for which a risk assessment
has been made.
H. Use Pattern Statement
Captan may only be used to formulate products
with established use—patterns including both single active and
multiple active ingredient products. Acceptable use—patterns
are listed in the USDA Compilation of Registered Uses of
Fungicides, Part I, pp. C—10—00.01 to C—10—00.2l and/or EPA
Index to Pesticide Chemicals for captan (issued: August 4, 1983).
35
-------
II. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
A. This portion of the guidance document is a Notice
issued under the authority of FIFRA 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 dataNdescribed
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 FIFRA sec. 3(c)(2)(B),
you are required to take appropriate steps to comply with
this i’ tic .
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 Data’ 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 2/ 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
1/ 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.
36
-------
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 “FIFRA
Section 3(c)(2)(B) Summary Sheet” [ EPA Form 8580—1, Appendix
11—31 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 develbping) the data. If you elect
this option, you must notify EPA which registrant(s) are
parties to the agreement.
OR
3. File 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)*/
/ FIFRA sec. 3(c)(2)(B) authorizes joint development of
data by 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)
37
-------
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 voluntat-y 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 Ext ensions of Time
EPA recognize 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 yo i think that you will need more time to generate the
required data than is allowed by EPA’s schedule, you may
submit a request Cor 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
E-acilities, and subject an unnecessarily large number of
animals to testing.
A noted earlier, EPA has discretion to suspend the
registration of a product when a registrant fails to submit data
• required under FIFRA Section 3(c)(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 FIFRA Section 3(c)(2)(B)(iii)]
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.
38
-------
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 datat listed on the
form entitled “Product Specific Data Report” (EPA Form
8580—4, Appendix 111—1) to fill gaps identified by EPA
concerning your product. Under the authority of h’IFRA 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 entitlQd “Must Data By Submitted
Under 3(c)(2)(B).” -
*/ Product specific data pertain to data that support the
formulation which is marketed; it usually includes product
chemistry data and acute toxicity data.
39
-------
Data Requirenent
§158.135 ‘mxicology
ACW E TESTI :
81—1 — Acute Oral Toxicity - Rat
81-2 — Acute Derinal 1\Dxicity
81—3 — Acute Inhalation Toxicity
— Rat
81—4 — Primary Eye Irritation
-Rabbit
81—5 — Primary Dermal Iritation
81—6 — Dermal Sensitization
81—7 — Acute Delayed
urotoxlcity - Hen 4
SUBCH} DNIC TESTIr fl :
82—1 — 90—Day Feeding —
Rodent, Non—rodent
82—2 — 21—Day Derrnal
TABLE A
GENERIC DP TA RE})UIREMEr fl’S )R CAPTANJ
Dzes E PA Have Data
To Satisfy This
Use 2/ Requirement? (Yes,
Patterns No or Partially)
Must
Additional
Data
Be Submitted
1/
Cortiposition
Bibliographic
Citation
Under
FIFRA Section
3(c)(2)(B)? 3 /
1 3AI
A,B,C,E,F,G,H,I
Yes
)t)054789
No
1 3AI
A,B,C,E,F,G,H,I
No
00U 4789
Yes
(9 menths)
TGAI r4P 5
A,B,C,E,F,G,H,I
Yes
00086288
No
‘ IGAI
A,B,C,E,F,G,H,I
Yes
00128621
No
‘ IGAI
A,B,C,E,F,G,H,I
No
00054791
Yes
(9 months)
‘I 3AI
A,B,C,E,F,G,H,I
Yes
00054791
No
1 AI
.
1t AI
‘ I 3 AI
A,C,E,I
A,B,C,E,F,G,H,I
Partially 6
No
(Rodent)
Yes
Yes
(Non—rodent,
18 months)
(12 months)
40
-------
TABLE A
GENERIC DATA REQU I REMENTh FOR CAPTAN
tXes EPA Have Data
Must Addiltional
To Satisfy This
Data Be Su itted
1/
Data_Requiren nt Composition
Use 2/
Pattern
Requirerr nt? (Yes,
Nb_or_Partially)?
Bibliographic
Citation
Under FIE RA Section
3(c)(2)(B)? 2 /
§158.135 ¶Ibxicology
(continued)
82—3 — 90—Day Dermal 113A1 A,B,C,E,F’,G,H,I
82—4 — 90—Day Inhalation — ‘ [ CAT A,B,C,E,F’,G,H,I Nb Yes (15 months)
Rat
82-5 - 90—Day Neurotoxicity- [ CAI
Hen/Marimal ‘
C(WNTC TE TIN33 :
83—1 — Chronic Toxicity — I CA I A,C,E Partially (rodent) 0013)316, 00129157, Yes (non—rodent,
2 species: Rodent 00129163 (rat) 36 months)
arid Non—rodent
83—2 — Oncogenicity Study — 1tA 1 A,C,E Yes 00130316, 00129157, Nb
2 species: Rat and 00129163, (rat) 00068076
Mc ise preferred 00126845 (mouse)
83—3 — Teratogenicity — A,C,E Yes 00093883 (rabbit),
2 species 00086806, 00126348
00078623 (hamster)
83—4 — Reproduction, ‘ [ CAl A,C,E Yes 00125293 (rat)
2—generation 00120315 (rat)
41
-------
TABLE A
GENERIC DATA RET)UIREMENTfl3 E’OR CAVrAN
es EPA 1-lave Data
Must Additional
To Satisfy This
Data Be Submitted
1/
Data Requiren nt Composition
Use 2/
Pattern
Requiremant? (Yes,
Nb or Partially)
Bibliographic
Citation
Under FI RA Section
3(c)(2)(BY? 3 ’
158.135 Tbxicology
(continued)
MLYrACENICITY TESTI NC
84—2 — Gene Mutation
84-2 — ChronDsomal Aberration
84—2 — Other MechanisnE of
Mutagenicity
SPECIAL TESTINC
85—2 — Dz stic Animal Safety 4
85-3 - [ Darmal Absorption
A,C,E
A,C ,E
PAl or P ,C,E
PAl RA
Choice
PAIRA
00087805, 00131715,
00114210, 00131725
00131727, 00114210,
00 l317 5
00117083
Yes (24 nDnths)
nicA l
n iGAI
I ’3A 1
A,C ,E
85—1 — General Metabolism
Yes
Yes
Yes
Nb
Yes
000 3608
00098787
42
-------
TABLE A
GENERIC DATA REX)UIREMEP.IIS FOR CAPTAN
§158.135 ‘DDxicology
(continued)
1/ Ccrnposition: ICAI = Technical grade active ingredient; PAl = 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, Food Crop; B=Terrestrial, Non—Food; C=F qautic, Food Crop;
D=Njuatic, Non—Food; E=Greenhouse, Food Crop; I?=Greenhouse, Non-Food; G=Forestry; H=1)xnestic ()jtdoor; I=Indoor.
3/ Data must be subnitted no later than indicated in Table A.
4/ This test is not required.
5/ The Manufacturir —Use Product (MOP) has added inerts, but will satisfy the requirement.
6/ The chronic rodent study satisfies part of this requirement.
43
-------
Data Requirement
§158.135 Toxicology
ACUTE TESTING
81—1 —
81—2 —
81—3 —
81—4 —
MP
MP
MP
MP
Yes
Nb
es
00054789
00054789
00086288
001)1.28621
00054791
Nb
Yes (9 nonths)
Nb
Nb
Yes (9 iunths)
1/ Composition: MP = Manufacturing—use product.
2/ Dat a must be subi itted no later than 9 nonths fran the date of receipt of this Standard.
TABLE B
PRODUCE SPECIFIC R’ A REX UIREMLEN’IS R MANUFACrURING-USE PRODUC’Pd c0NIrAINiNG CAPTAN
E 3es EPA Have Data
To Satisfy This
Requirement? (Yes,
Nb or Partially)
1/
Must
Additional
Data
Be Subtnitted
Bibliographic
Composition Citation
Under
FIF’RA Section
3(c)(2)(BY? 2 /
Acute Oral Toxicity — Rat
Acute Darmal Toxicity
Acute Inhalation Toxicity
— Rat
Primary Eye
Irritation — Rabbit
81-5 - Primary Dermal
Irritation
MP
81—6 — Dermal Sensitization MP
Yes
Nb
Yes
00054791
44
-------
Yes (9 months)
Yes (9 months)
Yes 5 (9 months)
Yes 6 (24 months)
Yes 7 (24 months)
Yes (27 months)
Yes (27 months)
Yes 8 (6 months)
Yes 9 (12 months)
Yes’ 0 (15 months
GENERIC DATA
Ccinposition ’ /
Use 2/
Pat tern
REI UIREMEE ITS EDR CAPTAN
.—
Wes EPA Have Data
Must
Additional
To Satisfy This
Data
Be Submitted
Requirement? (Yes,
Nb or Partially)
Bibliographic
Citation
Under
FII?RA Section
3(c)(2)(i3)? 3 /
Yes 4 (6 months)
Data Requirement
158.130 Environriental Fate
DEX3RADATION SThDI ES- LAB:
161—1 — Hydrolysis ‘1T AI or
PAIRA
A,B,C,D,E,F,H,I
Partially
00096974
Photodeg radat ion
161—2 — In water ‘RAI or
PAIRA
A,B,C
No
161-3 - On soil 1 AI or
PAIRA
A,
Nb
161-4 - In Air ‘IGAI or
PAIRA
A
Nb
METABOLISM STUDI ES-LAB:
162—1 — Aerobic Soil TUAI or
PAIRA
A,B,E,F,H
Partially
00070414
162—2 — Anaerobic Soil TGAI or
PAIRA
A
Partially
00098881
162—3 — Anaerobic Aquatic TGAI or
PAIRA
C’
162—4 — Aerobic Aquatic TUAI or
PAIRA
C
MOBILITY STUDIES:
163—1 — Leaching and ‘I AI or
Adsorpt ion/Desorpt ion
.
PAIRA
A,B,C,E,F,H
Partially
00096972
— Volatility (Lab) TEP
•
Nb
— Volatility (Field) TEP
A,E,F
Nb
163—2
163—3
45
-------
Data Requirerient Cc i sition 1 /
158.130 Environn ntal Fate (continued)
DISSIPATION STUDI E - FIELD :
164—1 — Soil TEP
164—2 — N uatic (Sedinent) TEP
Water TEP
164—3 — Forestry
164—4 — Cathination and
Tank Mixes
164—5 — Soil, Long—term
ACCUMULATION S’ilJDIE :
165—1 — Rotational Crops
(Confined)
165—2 — Rotational Crops
(Field)
165-3 — Irrigated Crops
165—4 — In Fish
165—5 — In N uatic Non—Target
Yes (39 rronths)
Yes (12 months)
GENERIC DATA
RE UIREMEt’TI’S FOR CAPTAN
[ bes EPA Have Data
Must
Addit iona1
use 2/
Pattern
To.Satis y This
Requirerrent? (Yes,
No or Partially)
Bibliojraphic
Citation
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)? 31
A,B,H
C
C
TEP -
EP A,C
PAIRA A,C
TEP A,C
TEP C
AI or PAIRA A,B,C
TEP
No
No
No
No
No
Yes (27 months)
Yes (27 months)
No
No
Yes (SO months)
Yes (39 months)
Yes (50 months)
46
-------
TABLE A
GENERIC_DATA_RE1 UIREME1’4TS_FOR_CAFTAN _______ ______________
DDes EPA Have Data Must Additional
To Satisfy This Data Be Submitted
Use 2 Requirement? (Yes, Biblieqraphic Under FIFRA Section
Data Requirement Composition Pattern N b or Partially) Citation 3(c)(2)(B)? 3
§158.140 Environmental Fate (continued)
Subdivision K (Reentry)
132—1 Foliar dissipation TEP A,B,C No Yes (27 months)
132—1 Soil dissipation TEP A,}3,C Nb Yes (27 months)
133—3 Dermal. Exposure TEP A,B,C Nb Yes (27 months)
133—4 Inhalation Exposure TEP A,B,C Nb Yes (27 months)
1/ Composition: IGAI = Technical grade of the active ingredient; PAIRA — Pure active ingredient, radiolabelled;
TEP = Typical end—use product.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non—Food; C=Aquatic, Food Crop;
D=N. uatic, Non—Food; E=Greenhouse, Food Crop; F’=Greenhouse, Non—Food; G=E’orestry; H=I) mestic Wtdoor; I=Indoor.
3/ Data must be subiiitted no later than indicated below in this table.
4/ Data on the trichloromethanethiol (TCMT) side chain of captan was incomplete and nonquantitative in the
partically acceptable study (00096974). Complete information on the fate and rates of formation and degradation
of this moiety is necessary before guidelines will be fulfilled.
5/ Because captan is applied as an EC and is suspended in water, hydrolysis will occur. Because there is incomplete
environmental fate and chemical data on captan arid TCMT under these conditions additional studies are required.
6/ The partially acceptable study (00070414) used carbonyl 14 C captan which acceptably documented the fate of the ring
portion of the captan molecule. The fate of the ‘I MT side chain was not addressed. The fate, rate of formation
and degredation of this portion of the captan molecule must be addressed in order to fulfill gi .Udelines requirements.
7/ The partially acceptable study (00098881) used carbonyl ‘ 4 C captan which acceptably documented the fate of the ring
portion of the captan molecule. The fate of the Tc rr side chain was addressed, however it appears that the extraction
technique used could preclude proper analysis of the fate of the side chain. The study is not required if an accept-
able anaerobic uatic study is conducted.
8/ The partially acceptable study (00096972) gives information on the leaching and adsorption/clesorption characteristics
of the parent captan molecule in clay arid 1ay loam soils only. The leaching and adsorption/desorption characteristics
of the parent compound must be addressed in sandy soil. •The major degradation products (TUPI and TCMT) were not
addressed in all major soil types.
9/ As there is incomplete data on vapor pressure of captan and TCMT, additional studies are required.
10/ The requirements for field volatility studies are reserved pending the results of laboratory volitili,ty studies
of captan and its TCMT deqredate.
4—
-------
TABLE A
GENERIC LY TA REOUI REMErIIS
Ft R CAPTAN
Data Requirerrent
Use
Composi tion ’ / Pattern 2 /
Does EPA Elave Data
To Satisfy This
Requiremant? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under F1E’RA Section
3(c) (2)(b) 3 /
158 .145 Wildlife and
Aquatic Organisms
Avian and Mammalian Testing
71—1 Avian Oral LD 50
AI
A B,C,E ’
F 1 / ,G, F , /
Yes
GSO12O—045 8 ” cs9999—oo1 8
000 20 56O /
71—2 Avian Dietary LC 50
a. waterfo i1
b. upland gaire
71—3 Wild Mammal Toxicity
71—5 Sinulated and Actual TEP
Field Testing for
Mammals and Birds
1 AI A,B
A,B,C,G,I-l
A,B,C,E 4 /,E 4 /,
G , I-I ,i /
000229238/
G 120—047 9 / 00146869/
000 229238/
000928968/
000982958/ 00104083 /
No
No
No
No
Aquatic Organism Testing
72-2 Acute LC 50 - Fresh-
water Invertebrates
A,B,C,
G,H
C
TGAT
TGAI
71—4 Avian Reproduction
a. waterf l
b. upland garre
1 AE
TGAI
Yes
Yes
No
Yes
Yes
A,B,C
A,B
A,B ,C
72—1 Freshwater Fish LC 50
a. warmwater
b. coldwater
1x Ai
TEP (50%)
No
G 3120—0 2 8 / GS0144—012 8 /
0003471 39/ 0005784 58/
No
Yes
‘JXAI
No
A,B,C,E 4 /,F /,G,H,I / Yes
000578468/;
GS0144—012
Yes
No
(9
months)
TEP
(50%)
C Nb
Yes
(9
months)
‘I AI
A,B,C,E ’,F’ ,F,G,H,I / Yes
00070751 ”;
00028759 /
GSO12O—041 8 ’
Nb
TEP
(50%)
C Nb
Yes
(9
months)
48
-------
2
TABLE A
GENERIC DATA RF1 UIRFj4ENrS
ft R CAPTAN
Data R uir ent
72—3 Acute Thxicity —
Estuarine and Marine
Organ i ts
Use
CcmpositionlLi Pattern L
EkDes EPA Have Data
To Satisfy This
Rejuiren nt? (Yes,
No or Partially )
Bib]. icx raphic
Ci tat ion
Must k:lditional
Data Be Submitted
Under FIFRA Section
3 2)(B). 7______
72—4 Fish Early Life Stage
and Pquatic Inverte-
brate Life—Cycle
72—5 Fish Life-cycle
72—6 kluatic Organiai
Accumulation
72—7 Simulated or Actual
Field Testing —
Pquatic Organians
1 AI A,C
A,C
PAl or
Degradation Product
Yes 5 /(12 rrv nths)
Yes 5 /(12 n nths)
Yes 5 /(12 rronths)
No
a. fish
b. shrinp
C. c ’ster
‘It A I
TGAI
TGAI
A,C
A,C
A,C
I AI A,C
Nb
No
Nb
No
Yes 000578468/
Nb
Nb
TEP A,C
No
Yes 6 /(1 year)
Yes 7
49
-------
FtXY NOTES TO TABLE A - WILDLIFE AND AQUATIC ORGANISMS
Ccinposition: TGAI = Technical graiie of active ingredient; PAl = pure active ingredient; TEP = typical 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 crop; E = Greenhouse, Food crop; F = Greenhouse, Nonfood crop; G = Forestry;
H = Danestic Outdoor; I = Indoor.
3/ Data must be submitted no later than indicated below.
14/ To support the MTJP when use includes “Indoor.”
5/ Data are required because the rice seed and citrus use patterns enccmpass greater than 300,000 acres in coastal
counties of the U.S., therefore creating potential to impact martne/estuarine organi s.
6/ Refer to the requirenents for envirormental fate chapter.
7/ Protocols addressing this requirenent are to be submitted to the gency within three (3) months. Protocols
must receive written gency approval prior to conducting such studies. The date when the data are to be submitted
will be determined by the f gency based on the protocols and will be given in the review of the protocols.
8/ Study fulfills guideline requirenents when considered alone.
9/ Study must be ccinbined with other st,udies to fulfill guideline requirenents.
50
-------
TABLE A
GENERIC DATA REQUIR 21ENTS FOR CAPTAN
Does EPA Have Data Must Additional
Use To Satisfy This Data Be Submitted
Data Requirement Composition 1 Pattern 2 Requirement? (Yes, Bibliographic Under FIFRA Section
No or Partially) Citation 3(c)(2)(B)? 3
ç158.155 Nontarget Insect
NONTARGET INSECT TESTING-
POLLINATORS:
141—1 — Honeybee acute TGAI A,B,G,H Yes 00080871 No
contact LD 5 c, 05001991
141—2 — Honeybee — toxicity
of residues on
foliage TEP A,B,GIPH No - No 4
1 41 —4 — Honeybee subacute
feeding study (Reserved] 5
141—5 — Field testing for
pollinators TEP A,B,G,H No — No 4
j Compositions TGAI = Technical grade of the active ingredient; TEP = Typical end-use product.
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. DzzAquatic, Nonfood; E=Greenhouse, Food Crop; F=Greenhouse, Nonfood; G=Forestryj H=Domestic
Outdoor; I Indoor.
Data must be submitted no later than
As data from the acute contact test indicate low toxicity, no fur;her besting is required.
Reserved pending development of test methodology.
/ Reserved pending Agency decision as to whether the data requirement should be established.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
Does EPA Have Data Must Additional
Use To Satisfy This Data Be Submitted
Data Requirement Composition Pattern Requirement? (Yes, Bibliographic Under FIFRA Section
No or Partially) Citation 3(c)(2)(B)?
ci 58.1 55 Nontarget Insect
(continued)
NONTARGET INS XT TESTING -
AQUATIC INSEXTSz
142—1 — Acute toxicity to
aquatic insects (Reserved 6 ]
142—2 — Aquatic insect
life-cycle 8tudy (Reserved 6 ]
142—3 — Simulated or actual
field testing for
aquatic insects (Reserved 6 ]
143-1 - NONTARGET INSEXT
thru TESTING - PRmATORS
143—3 AND PARASITES [ Reserved 6 )
52
-------
TABLE A
GENERIC [ 1A TA RB UIREMENTI’S FOR CAPTAN
Data Requiren nt
Conipositionl/
Does EPA Have Data
To Satisfy This
Requirerr nt? (Yes,
P b or Partially)
Bibliographic
Citation
Must Additional
Data Be Subnitted
Under FIFRA Section
3(c) (2) (B) 2 /
§158.125 Residue Chemistr 1
171-4 — Nature of Residue (Metabolism)
— Plants
— Livestock
174—4 — Residue Analytical Method
PAT RA
PAIRA and plant
metabol i tes
— Plant residues
Pure Analytical
Standards and
metaboli tes
Partially
See Footnote C
Yes 5
— Animal residues
Presently there are
no established tolerances
Pure Analytical
Standard and
netabol i tes
Partially
See Footnote C
Yes 5
171—4 — Storage Stability Data PAT
A. Bibliographic Citations: 00058941, 00083100, 00096978, 00098790, 00098831, GSO12O—001, 00128355.
B. Bibliographic Citations: 00058940, 00098786, G50120—003, GSO12O—004, 00128355, 00096901, 00096908.
C. Bibliographic Citations:
00002927 , .0000 2928,
00042646, 00045174,
00045188, 00045189,
00085525, 00085526,
00098726, 00098731,
00098811, 00098817,
GSO12O—01l, 00128355.
00003025,
00045175,
00053324,
00090988,
00098747,
00098818,
00025123,
00045176,
00054015,
00090989,
00098751,
00117087,
00025125, 00035246, 00035248, 00042645,
00045179, 00045182, 00045183, 00045184,
00054016, 00070201, 00071790, 00083393,
00096910, 00096982, 00097622, 00098720,
00098784, 00098789, 00098804, 00098810,
GSO12O—008, 00098894, 00128355,
Partially See Footnote A
Partially See Footnote B
Yes 3
yes
Yes 6
53
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
Data Requirement
Composition 1 /
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c) (2)(B) 2 /
c158.125 Residue Chemistry
(continued)
171—4 — Magnitude of the Residue—
Residue Studies for Each
Food Use
Root and Tuber Vegetable Groupa
Beets, Garden 1
Carrots 2
Potatoes 3
Taro 4
Tur nip5
Leaves of Root and Tuber Vegetable Groupb
Beet Green 1 EP
Taro Leaves 2 EP
Turnip Greens 3 EP
Bulb Vegetable Groupc
Garlic 1
Leeks 2
On ions 3
Shallots 4
00098716
00098894
00054016
Leafy Vegetables (except brassica) Groupd
Celeryl EP
Lettuce 2 EP
Rhubarb3 EP
Spinach 4 EP
No
Partially
No
Part i. ally
Yes
00070201 Yes
- Yes
00070201 Yes
Brassica Leafy Vegetab le Groupe
Broccoli 1
Brussels Sprouts 2
00070201 Yes
- No
EP No
EP No
EP No
EP No
EP No
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes 7
Yes
Yes 8
Yes 8
Yes
Ye 8
EP No
EP No
EP No
EP No
EP
EP
Partially
No
54
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
Data Requirement
Composition 1 /
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2) (B) 2 !
158.125 Residue Chemistry
(continued)
171—4 - Magnitude of the Residue-
Residue Studies for Each
Food Use
Cabbage 3
Cauliflower4
Collards 5
Kale 6
Mustard Greens 7
Legume Vegetabl s Group!
Beans (Dry and succulent)l
Peas (Dry and Succulent) 2
Soybeans 3
EP
EP
EP
Foliage and Legume Vegetable Groups
Bean Vines and Hay l EP
Pea Vines and Hay 2 EP
Soybean Forage, Hay and Straw 3 EP
Partially
No
Partially
No
No
Partially
00046914
00070201
00098710
00071790
00096982
00098709
Yes
Yes
Yes
Yes
Yes
Yes
Fruiting Vegetables (except Cucurbits) Grouph
Eggplantl
Peppers 2
Toma toes 3
Partially
Partially
Partially
00098709
00070201
00085526
00098708
Yes
Yes
Yes
EP
No
Yes
EP
No
Yes
EP
No
No
EP
No
Yes
EP
No
Yes
EP
EP
EP
55
-------
TABLE A
GENERIC E TA RE) UIREMEt’JtS FOR CAPTAN
Data Requiren nt
Com xsition”
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
f b or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B) 2 ’
§158.125 Residue Chemistry
(continued)
171—4 — Magnitude of the Residue—
Residue Studies for Each
Food Use
Citrus GroipJ
Grapefruit 1
Lertuions 2
L
Ora r es 4
Tangerines 5
Pome Fruits Groupk
Apples l
EP
EP
EP
EP
EP
EP
EP
00098709
00098818
00 128355
00128355
00085526
00058941
00085524
00098759
00128355
00085526
00098722
00098789
00106602
00128355
00128355
00098711
00128355
Yes
Yes
Yes
Yes
Yes
Yes
1’b
Yes
Cucurbit Vegetable Group
Cucumber 1
Melons (excluding watern lon) 2
Pumk ins 3
Watermelortt
Partially
Partially
Partially
Partially
Partially
Partially
1’b
Partially
1’b
EP
EP
EP
Crabapples 2
Yes
Yes 8
56
-------
TABLE A
GEI’IERIC IY TA REI UI REME I S EOR CAPTAN
Data Requiren nt
ompos it ionl /_
IY es EPA Have beta
To Satisfy This
Requiren nt? (Yes,
Nb or Partially)
Bibliographic
Citation
Must Additional
Data Be Subeitted
Under FIFRA Section
3(c) (2)(B) 2 /
§158.125 Residue Chemistry
(continued)
171—4 — Magnitude of the Residue—
Residue Studies for Each
Food Use
EP
EP
EP
EP
EP
Partially
Partially
Partially
Partially
Partially
0070201
00055526
00098722
00106602
00128355
00128355
00128355
00128355
00128355
00128355
Yes
Yes
Yes
Yes
Yes
Small Fruits and Berries Group!
Blackberries’
Blueberries 2
Cranberries 3
Dewbe rries 4
Grapes 5
00046914
00070201
00090988
00128355
00070201
00046914
00070201
00090988
00098726
00128355
00128355
EP
EP
Pears 3
Quinces 4
Stone Fruits Group 1
Apricots 1
Cherries 2
r ectarines 3
Peaches 4
Plums (fresh prunes) S
Partially
Nb
Yes
EP Nb
EP Partially
EP Partially
EP
EP Partially
No
Yes
Yes
No
Yes
57
-------
TABLE
GENERIC DATA RFX)UIREMENI FOR CAPTAN
Data Requirenent
Composition 1 /
E es EPA Have Data
To Satisfy This
Requirenent? (Yes,
t b or Partially )
Bibliographic
Citation
Must Additional
Data Be Submitted
Under l,’IFRA Section
3(c)(2)(B) 2 /
§158.125 Residue Chemistry
(continued)
171—4 — Magnitude of the Residue-
Residue Studies for Each
Food Use
00070201
00090988
00098804
00098811
00128355
00128355
Cereal Grains Graip°
Corn’
EP
Partially
00045176
00070201
GS O12O—039
00128355
Yes
Herbs and Spices GroupP
Dill 1
Parsley 2
Avocadc1
Raspberries 6
Strawberries 7
Tree its Groupfl
Almonds!
EP
EP
EP
Partially
0070201
Yes
Partially
00046914
00070201
00090988
00117088
00128355
Yes
Partially
Yes
EP
EP Partially No 7
EP Partially No 7
Yes
58
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
Data Requirement
Composition 1 I
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c) (2)(B) 2 /
158.125 Residue Chemistry
(continued)
171—4 - Magnitude of the Residue—
Residue Studies for Each
Food Use
Co ttonseedS
EP
Partially
0002928
00070201
00090988
Yes
Kiwi t
EP
Partially No
PineappleU
EP
Partially
00085526
00098719
Yes
Seed TreatinentsV
Food Packing BoxesW
EP
Partially
EP No
0003025
00025125
00035246
00035248
000451 78
00096910
00098751
00098808
00098810
0010453
Yes
Yes
Man go e sr
EP No Yes
Meat, Milk, Poultry and EggsX
EP
Partially
Yes
59
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
158.125 Residue Chemistry (continued )
a. crop group tolerance is not appropriate at the present time for the following reasons:
Additional residue data are required to support the existing tolerances for captan residues in or on
potatoes and carrots.
Data are required for two additional group members (radishes and sugar beets).
The registered uses of captan formulations on group members with established tolerances are markedly
dissimilar (foliar, preplant, postharvest, and seed treatment.
The following data are needed for support of existing tolerances on the following commodities:
1. Beets, Garden (Beet, Roots ) - No data were submitted to support the established tolerance for
residues of captan in or on garden beets. The following data are required:
The requested test protocols recognize that the registrant(s) may seek cancellation of foliar and/or
preplant use of captan formulations to permit tolerance reductions (Captan Special Review Position
Document 2/3, dated June 1985); thus, depending upon the registrant’s wishes, data from one of the
following three test protocols must be submitted:
i. If the registrant wishes to retain registered preplant and foliar uses data depicting captan
residues of concern in or on beets harvested after a preplant soil application of a WP formu-
lation of 6.56 lb al/A, followed by multiple foliar applications at 7- to 10— day intervals of
a F1C or WP formulation at 1.2 lb ai/100 gal are required. Beets must be harvested on the day
of last foliar application. Foliar applications must be made using both ground and aerial
equlpBent. Alternatively, the registrant may propose a label amendment to omit aerial appli-
cations and stibmit tests using ground equipment only. Also, the registrant should propose a
label amendment limiting the number of gal/A/application, and the number of applications/
season or lb ai/A/season to those reflected in the above—required tests. Tests must be con-
ducted in WI, NY, CA, and TX, which represent prominent canning beet production areas (Ware,
G.W., and J.P. NcCollum, 1980; Producing Vegetable Crops , Interstate Printers & Publishers,
Inc., p. 422). State production percentages are not available.
ii. If the registrant wishes to cancel foliar uses, then only data reflecting preplant tests
described above are required and an appropriate tolerance revision must be proposed.
iii. If the registrant wishes to cancel foliar and preplant uses and retain seed treatment uses,
data depicting captan residues of concern in or on crops grown from treated seed must be sub-
mitted (refer to section entitled Seed Treatments for details of data requirements) and art
appropriate tolerance revision must be proposed.
60
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
c158.125 Residue Chemistry (continued )
2. Carrots — The requested test protocols recognize that the registrant(s) may seek cancellation of
foliar use of captan formulations to permit tolerance reductions (Captan Special Review Position
Document 2/3, dated June 1985); thus, data reflecting only one of the following treatment regimens
are required:
i If the registrant wishes to retain foliar uses, tests must include multiple foliar applications
at 6— to 10—day intervals with either a WP or F1C formulation at 3 lb ai/A/application and
samples of mature roots must be obtained on the day of final treatment. These data must depict
captan residues of concern. Applications must be made using both ground and aerial equipment.
Alternatively, the registrant may propose a label amendment to omit aerial applications and sub-
mit only tests using ground equipment. Also, the registrant should propose a label amendment
limiting the maximum number of applications or lb al/season rate to that reflected in the above—
required tests. These tests must be conducted in CA (51%), TX (14%), and either MI (7%), MN
(2%), or WI (7%), which represent major U.S. carrot production areas; production percentages
cited in Agricultural Statistics , 1984, p. 153, appear in parentheses.
ii. If the registrant wishes to cancel foliar use and retain seed treatment uses, data depicting
captan residues of concern in or on crops grown from treated seed must be submitted (refer to
the section entitled Seed Treatment for details of data requirements) and an appropriate
tolerance revision must be proposed.
3. Potatoes — The available data are insufficient to assess the interim tolerance for residues of captan
in or on potatoes for the following reasons: Ci) no data were submitted concerning foliar appli-
cations; (ii) no data were submitted concerning residues resulting from postharvest applications;
(iii) insufficient data were submitted reflecting residues resulting from seed piece treatment; (iv)
no data were submitted reflecting residues of concern in processed products of potatoes; and (v) geo-
graphic representation was inadequate. The following additional data are required:
The following requested test protocols recognize that the registrant(s) may seek cancellation of
foliar and or postharvest use of captan formulations to permit tolerance reductions (Captan Special
Review Position Document 2/3, dated June 1985); thus, depending upon the registrant’s wishes, data
from one or more of the following three test protocols must be submitted:
i. If the registrant wishes to retain registered foliar and postharvest uses, tests must include
multiple toliar applications at 5— to 7-day intervals with a WP formulation at 6 lb ai/A/appli-
cation. Samples must be harvested on the day of final treatment and, on the same day, receive
a postharvest, slurry dip application with the 50% WP at 1.25 ai/100 gal. These data must
depict captan residues of concern. Foliar applications must be made using both ground and
aerial equipment.
61
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
158.125 Residue Chemistry (continued)
Alternatively, the reqistrant may propose a label amendment to omit aerial applications and
submit only tests using ground equipment. Also, the reqistrant should propose a label amend-
ment limiting the maximum number of applications or lb ai/A/season rate to that reflected in
the above-required tests. These tests must be conducted in ID (— ‘25%), OR ( -‘-‘6%) and ME
(- 7%) which represent the major U.S. potato production areas; state production percentages
appear parenthetically ( Agricultural Statistics , 1984, p. 165)
ii. If the registrant wishes to cancel foliar and postharvest uses and retain seed piece treatment
uses, data depicting captan residues of concern in or on potatoes must be submitted (refer to
the section entitled Seed Treatment for details of data requirements) and an appropriate toler-
ance revision must be proposed.
iii. If the registrant wishes to cancel postharvest uses and retain foliar use, then only data re-
flecting foliar tests described above are required and an appropriate tolerance reduction
should be proposed.
Data reflecting the concentration of residues of concern in processed products of potato (gran-
ules, chips, and dried potatoes). Data must reflect potatoes with measurable, weathered res-
idues. Should residues be found to concentrate upon processing, appropriate food/feed addi-
tive tolerances must be proposed.
4. Paro — The available data are insufficient to assess the established tolerance for residues of captan
in or on taro root because no data depicting residues in or on whole taro root were presented. The
following additional data are required:
Residue data pertaining to compounds of concern in or on taro root harvested after a single preplant
soil treatment at 50 lb al/A. These tests must be conducted in HI, the only State in which captan
is registered for use on taro, and must reflect application to wetland taro only.
5. Turnip - No data were submitted to support the established tolerance for residues of captan in or on
turnip root. The following data are required:
Data depicting captan residues of concern in or on turnips harvested after a single preplant soil
application, followed by incorporation, with a WP formulation at 7 or 14 lb ai/A; the maximum permis-
sible per acre rate is to be specified by the registrant. Tests must be conducted in GA, TX, and
either OH or PA which represent the major turnip production areas designated in Vegetable Crops , 15th
D i., H.C. Thompson and W.C. Kelly, 1957, p. 338; individual State production percentages are not
available.
62
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
158.125 Residue Chemistry (continued )
The registrant must propose a label amendment specifying the maximum rate permitted for the 5% D
formulation. Residue tests reflecting this use will not be required unless the maximum rate is in
excess of that specified for the WP formulation.
If the registrant wishes to cancel preplant uses and retain seed treatment uses, then data depicting
captan residues of concern in or on crops grown from treated seed must be submitted (refer to section
entitled Seed Treatment for details of data requirements) and an appropriate tolerance revision must
be proposed.
b. Leaves of Root and Tuber Vegetable Group - A crop group tolerance is not appropriate at the present time
for the following reasons:
Additional data are required to support the existing tolerance for captan residues in or on turnip
greens.
Registered uses, and established tolerances are dissimilar for members of the leaves of root and tuber
group.
Residue data must be submitted and a use proposed for captan formulations on one additional group member
(sugar beets).
1 • Beet Greens — No data have been submitted to support the established tolerance for residues of captan
in or on beet greens. The following data are required:
The requested test protocols recognize that the registrant(s) may seek cancellation of preplant and/
or foliar use of captan formulations to permit tolerance reductions (Captan Special Review Position
Document 2/3, dated June 1985); thus, depending upon the registrant’s wishes, data from one of the
following three test protocols must be submitted:
i. If the registrant wishes to retain registered preplant and foliar uses, data depicting captan
residues of concern in or on garden beet greens harvested after preplant soil application with
a Wp formulation at 6.56 lb ai/A followed by multiple foliar applications at 7— to 10-day in-
tervals with a F1C or WP formulation at 1.2 lb ai/100 gal are required. Beet greens must be
harvested on the day of the last foliar application. Foliar applications must be made using
both ground and aerial equipment. Alternatively, the registrant may propose a label amendment
to omit aerial applications and submit only tests using ground equipment. Also, the registrant
should propose a label amendment limiting the number of gal/A/application and the numb r of
applications/season or lb ai/A/season to that reflected in the above—required tests. Tests
must be conducted in WI, NY, CA, and TX, which represent prominent canning beets production
areas (Ware, G.W., and J.P. McColluin, 1 .980; Producing Vegetable Crops , Interstate Printers &
Publishers, Inc., p. 422). State production percentages are not available.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
158.125 Residue Chemistry (continued )
ii. If the registrant wishes to cancel foliar uses and retain preplant uses, then only data re-
flecting preplant tests described above are required and an appropriate tolerance reduction
should be proposed.
iii. If the registrant wishes to cancel foliar and preplant uses and retain seed treatment uses,
data depicting captan residues of concern in or on crops grown from treated seed must be sub-
mitted (refer to the section entitled Seed Treatment for details of data requirements) and an
appropriate tolerance revision must be proposed.
2. Taro Leaves — No tolerance for residues of captan in or on taro leaves has been established. A
tolerance of 0.25 ppm is pending for residues of captan in or on taro leaves [ PPfl7E1982; amendment
of November 30, 1983).
3. Turnip Greens - No data were submitted to support the established tolerance for residues of captan
in or on turnip greens. The following data are required:
Data depicting captan residues of concern in or on turnip greens harvested after a single preplant
soil application, followed by incorporation, with a WP formulation at 7 or 14 lb ai/A; the maximum
permissible per acre rate is to be specified by the registrant. Tusts must be conducted in GA, TX,
and either OH or PA which represent the major turnip production areas designated in Vegetable Crops ,
5th Ed., H.C. Thompson and W.C. Kelly, 1957, p. 338; individual State production percentages are
not available.
The registrant must propose a label amendment specifying the maximum rate permitted for the 5% D
formulation. Residue tests reflecting this use will not be required unless the maximum rate is in
excess of that specified for the WP formulations.
If the registrant wishes to cancel preplant uses and retain seed treatment uses, then data depicting
captan residues of concern in or on crops grown from treated seed must be submitted (refer to section
entitled Seed Treatments for details of data requirements) and an appropriate tolerance revision
must be proposed.
c. Bulb Vegetable Group - A crop group tolerance is not appropriate at the present time for the following
reasons:
Mditional data are required for green onions and bulb onions, two representative commodities (see
Onions section for details of data requirements).
Use directions must be proposed for an additional representative commodity (garlic, leeks, or shallots)
and appropriate supporting data must be submitted.
64
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
158.125 Residue Chemistry (continued )
1. Garlic — As captan is not federally registered for use on garlic, we recommend that the established
tolerance be cancelled. Alternatively, the registrant may propose use directions and submit appro-
priate supporting residue data.
2. Leeks — As captan is not federally registered for use on leeks, we recommend that the established
tolerance be cancelled. Alternatively, the registrant may propose use directions and submit appro—
priate supporting residue data.
3. Onions — No acceptable residue data were available to assess the adequacy of the established
tolerance. Data obtained with analytical methods which prescribed colorimetric determination
of surface extractable residues rather than macerations of whole samples were considered inadequate.
The following data are required:
The requested test protocols recognize that the registrant(s) may seek cancellation of preplant,
foliar and/or postharvest use of captan formulations to permit tolerance reductions (Captan Special
Review Position Document 2/3, dated 6/85); thus, depending upon the registrant’s wishes, data from
one of the following test protocols must be subn itted:
i. If the registrant wishes to retain registered preplant, foliar and postharvest uses, data
must be submitted depicting captan residues of concern in or on green and dry bulb onions
treated once preplant with the 5% D at 2 lb ni/A and several times foliarly with the 5% D
and, in separate tests, with a wp formulation at 1.5 lb ai/A. Foliar applications should
begin at the normal time of disease development and continue at 7-day intervals until
the day of harvest. On the final day of foliar treatment, green and dry bulb onions must
receive a postharvest treatment (dip or spray) at 1.28 lb ai/lOO gal using a WP formulation.
Foliar applications must be by ground and aerial equipment (in separate tests); alternatively,
the registrant may propose deletion of aerial use and submit only tests using group equipment.
Also, the registrant(s) must propose a maximum permissible number of applications or lb ai/A/
season; the data reflected above must reflect the maximum seasonal rate proposed. Tests
should be conducted in CA (29.6%), TX (14.2%), OR (13.6%), MI (5.9%), and NY (7.3%), which
represent the major U.S. onion production areas ( Agricultural Statistics , 1984, p. 162);
State production percentages are given parenthetically.
ii. If the registrant wishes to cancel postharvest use and retain preplant and foliar uses,
then only data reflecting preplant and foliar tests described above are required and an
appropriate tolerance reduction should be proposed.
iii. If the registrant wishes to cancel foliar and postharvest uses and retain preplant use,
then only data reflecting preplant tests described above are required and an appropriate
tolerance reduction should be proposed.
65
-------
TABLE A
GENERIC DATA REQIJIRE24ENTS FOR CAPTAN
158.125 Residue Chemistry (continued )
iv. If the registrant wishes to cancel foliar, preplant, and postharvest uses and retain seed
treatment uses, data depicting captan residues of concern in or on crops grown from treated
seed must be submitted (refer to the section entitled Seed Treatments for details of data
requirements) and an appropriate tolerance revision must be proposed.
4. Shallots - As captan is not federally registered for use on shallots, we recommend that the
established tolerance be cancelled. Alternatively, the registrant may propose use directions
and submit appropriate supporting residue data.
d. Leafy Vegetables (except brassica) Group — A crop group tolerance is not appropriate at the present
time for the following reason:
Additional data are needed to support the established tolerances for residues in or on lettuce (head
and leaf), celery and spinach.
1. Celery — No acceptable residue data were available to assess the adequacy of the established
tolerance. Data obtained with analytical methodology which prescribed colorimetric determina- .
tion of surface extractable residues rather than macerations of whole samples were considered
inadequate. No acceptable data were submitted which reflected any use of captan formulations.
The following data are required:
The requested test protocols recognize that the registrant(s) may seek cancellation of foliar
use of captan formulations to permit tolerance reductions (Captan Special Review Position
Document 2/3, dated June 1985); thus, data reflecting only one of the following test regimens
are required:
i. If the registrant wishes to retain foliar uses, tests must reflect multiple foliar
applications of a wp formulation (applied at 1 lb ai/lO0 ga. of spray, using 200 gal/A),
and (in separate tests) a D formulation applied at 2.25 1b al/A. Applications should
be repeated at 7—day intervals.
ii. If the registrant wishes to cancel foli r uses and retain plant bed uses then tests must
reflect multiple plant-bed applications of a WP formulation (and, in separate tests, a D
formulation) applied at 6.5 lb al/A (for the WP, the use rate should be 1 lb ai/lOO gal
of spray, applied at 450 gal/A).
66
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
158.125 Residue Chemistry (continued )
These tests should reflect a 0—day posttreatznent interval. The registrant may propose cancellation
of uses of D formulations, in lieu of conducting studies with D formulations. Tests should use
ground and (in separate tests) aerial application methods. The registrant may propose label
modifications to eliminate aerial application in lieu of conducting aerial studies. Studies
should be conducted in CA (57.5%) and FL (21.2%), which collectively represent 78.7% of total
1983 U.S. celery production ( Agricultural Statistics , 1984, p. 156). The registrant must propose
a maximum seasonal use rate, and provide supporting data.
2. Lettuce - The available data are insufficient to support the existing tolerance of 100 ppm captan
for residues of captan in or on lettuce, since application methods and sample composition were
not identified, leaf lettuce data were not provided, and few head lettuce tests reflected a 0-day
posttreatment interval. The following additional data are required:
Data depicting captan residues of concern in/on both head lettuce (with and without wrapper leaves)
and leaf lettuce from tests reflecting multiple foliar application of the 50% WP at 1 lb ai/l00 gal
of spray (using 200 gal spray/A), repeated at 7-day intervals are required. The tests must reflect
a 0-day posttreatment interval. Ground equipment must be used to apply the compound; the registrant
may conduct additional tests reflecting aerial application, or may propose label modifications to
eliminate this use. The registrant may conduct additional tests reflecting the use of a D formula-
tion at 2.5 lb ai/A, repeated at 7—day intervals by ground and air (see above) equipment, or may
propose label modifications eliminating such uses. The registrant must propose a maximum seasonal
use rate and provide supporting data. These tests should be conducted in CA (69.4%) and AZ (18.7%),
which together represent 83.5% of the 1983 U.S. lettuce—growing regions ( Agricultural Statistics ,
1984, p. 160).
3. Rhubarb - The available data (a single study) do not provide sufficient information to permit the
evaluation of the established tolerance for captan residues. The following data are required:
Data depicting residues of captan residues of concern in/on rhubarb from studies reflecting multiple
foliar applications of a wP formulation (at 1 lb a/100 gal spray) and a 0-day PHI. The registrant
must propose a maximum seasonal use rate and a maximum single application rate (lb ai/l000 ft 2 ) and
provide supporting data. Tests should be conducted in MI (16.3%), OR (20.4%), and WA (39.5%), which
collectively represent 76.2% of total U.S. 1978 rhubarb acreage (1978 Census of Agriculture, Vol. I,
p. 187).
4. Spinach - The available data are i 1 nadequate for evaluation of the established tolerance for captan
residues in/on spinach, since no data reflected the use of preplant or at-plant treatments, only two
samples reflected multiple foliaritreatments, geographic representation was inadequate, and no data
reflected a 0-day posttreatment interval. The following additional data are required:
67
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
c158.125 Residue Chemistry (continued )
The requested test protocols recognize that the registrant(s) may seek cancellation of foliar,
preplant, and/or at—plant use of captan formulations to permit tolerance reductions (Captan Special
Review Position Document 2/3, dated June 1985); thus, data reflecting only one of the following test
regimens are required:
i. If the registrant wishes to retain registered preplant, at—planting, and foliar uses; data
depicting captan residues of concerp in or on spinach harvested after a single preplant
broadcast application of a D formulation at 6 lb ai/A, an at-plant application of a WP or
D formulation at 3.5 lb ai/A and multiple foliar applications at 7-day intervals (by ground
and, in separate tests, aerial equipment) of a WP formulation at 1 lb ai/l00 gal (applied
at 200 gal/A), an EC at 0.21 lb ai/l00 gal, and a D at 4.0 lb ai/A (each in separate tests).
The registrant must propose a maximum gal/A rate (for the EC formulation) and a maximum
seasonal use rate and provide supporting data. These tests reflect a 0—day posttreatment
interval. The registrant may propose cancellation of D formulation uses and aerial appli-
cation on spinach in lieu of conducting the tests representing these uses. Studies should
be conducted in CA (38.1%), AR (4.5%), MD (5.2%), NJ (3.8%), OK (4.8%), and TX (20.1%),
which collectively represent 76.5% of total 1978 U.S. spinach acreage (1978 Census of
Agriculture, Vol. I, p. 187).
ii. If the registrant wishes to cancel foliar uses and retain preplant and at-plant uses, then
only data reflecting preplant and at—plant above are required and an appropriate tolerance
reduction should be proposed.
iii. If the registrant wishes to cancel foliar and preplant uses and retain seed treatment uses,
data depicting captan residues of concern in or on crops grown from treated seed must be
submitted (refer to the section entitled Seed Preatment for details of data requirements)
and an appropriate tolerance revision must be proposed.
e. Brassica Leafy Vegetable Group - A crop group tblerance is inappropriate at the present time for the
following reasons:
Available data do not support the established tolerance for residues in or on broccoli, a representative
commodity of this group.
Data must be submitted for cabbage and mustard greens, representative commodities of this group.
1. Broccoli — The available data are inadequate to support the established tolerance because no data
reflecting the registered preplant use were submitted. The following data are required:
68
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
158.125 Residue Chemistry (continued)
The requested test protocols recognize that the registrant(s) may seek cancellation of certain uses
of captan formulations to permit tolerance reductions (Captan Special Review Position Document 2/3,
dated 6/85); thus, data reflecting only one of the following test regimens are required:
i. If the registrant wishes to retain preplant use, data must be submitted pertaining to captan
residues of concern in or on broccoli following preplant treatment with a WP formulation at
7.5 or 14 lb ai/A (the maximum application rate must be clarified). Tests must be conducted
ir CA where 90% of the domestic broccoli is produced ( Agricultural Statistics , 1984, p. 15
ii. If the registrant wishes to cancel preplant uses and retain seed treatment uses, data epicting
captan residues of concern in or on crops grown from treated seed must be submitted (refer to
the section entitled Seed Treatment for details of data requirements) and an appropriate
tolerance revision must be proposed.
2. Brussels Sprouts — No data were submitted for brussels sprouts. However, since the registered use
on broccoli is similar to that on brussels sprouts, the requested data for broccoli will be trans-
lated to brussels sprouts.
3. Cabbage — No data were submitted to support the established tolerance for residues in or on cabbage.
The following data are required:
The requested test protocols recognize that the registrant(s) may seek cancellation of certain uses
of captan formulations to permit tolerance reductions (Captan Special Review Position Document 2/3,
dated June 1985); thus, data reflecting only one of the following test regimens are required:
i. If the registrant wishes to retain preplant use, data must be submitted pertaining to captan
residues of concern in or on cabbage (with and without wrapper leaves) following preplant
treatment with a wP formulation at 7.5 or 15 lb al/A (the maximum application rate must be
clarified). Tests must be conducted in NY (- 2l%), FL (- l7%), TX (—16%), WI
(--9% and CA (—6%), which represent the major cabbage producing reqions of the country
(Ware, G.W. and J.p. McCollum. 1980. Producing Vegetable Crops , 3rd ed., p. 259); State
production percentage are given in parentheses.
ii. If the registrant wishes to cancel preplant uses and retain seed treatment uses, data depicting
captan residues of concern in or on representative crops grown from treated seed must be sub-
mitted (refer to the section entitled Seed Treatment for details of data requirements) and an
appropriate tolerance revision must be proposed.
69
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
158.125 Residue Chemistry (continued )
4. Cauliflower — No data were submitted for cauliflower. However, since the registered use on broccoli
is similar to that on cauliflower, the requested data for broccoli will be translated to cauliflower.
5. Collards — No data were submitted for collards. However, since the registered use on mustard greens
is similar to that on collards, the requested data for mustard greens will be translated to collards.
6. Kale — No data were submitted for kale. However, since the registered use on mustard greens is
similar to that on kale, the requested data for mustard greens will be translated to kale.
7. Mustard Greens — No data were submitted to support the established tolerance for residues of captan
in or on mustard greens. Therefore, the following data are required.
The requested test protocols recognize that the registrant(s) may seek cancellation of certain uses
of captan formulations to permit tolerance reductions (Captan Special Review Position Document 2/3,
dated June 1985); thus data reflecting only one of the following test regimens are required:
i. If the registrant wishes to retain preplant use, data must be submitted pertaining to captan
residues of concern n or on mustard greens following preplant treatment with a WP formulation
at 7.5 or 14 lb ai/A (the maximum rate must be clarified). Tests must be conducted in TX, CA,
and GA, the leading producers of mustard greens (Seelig, R.A. 1970. Mustard Greens. Fruit
and Vegetable Facts and Pointers . United Fresh Fruit and Vegetable Association); State produc-
tion percentages were not available.
ii. If the registrant wishes to cancel preplant uses and retain seed treatment uses, data depicting
captan residues on concern in or on representative crops grown from treated seed must be sub-
mitted (refer to the section entitled Seed Treatment for details of data requirements) and an
appropriate eolerance revision must be proposed.
f. Legume Vegetables Group - A crop group tolerance is not appropriate at the present time for the following
reasons:
Data requirements to support the established tolerances for residues in or on beans (succulent and dry)
and peas (succulent and dry) must be satisfied.
The registered uses of captan formulations on beans and soybeans (foliir and preplant) differs from that
for peas (preplant or at-plant).
70
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
158.125 Residue Chemistry (continued)
1. Beans (Dry and Succulent ) - The available data are inadequate for evaluation of the established
tolerances for captan residues in or on dry and succulent beans, since submitted data did not
depict residues on dry or lima beans, did not depict residues resulting from pre— or at-plant
treatments to succulent bean varieties, did not reflect more than two foliar treatments per season
(two in only one study), and did not provide adequate geographic representation. The following
additional data are required:
The requested test protocols recognize that the registrant(s) may sek cancellation of certain uses
of captan formulations to permit tolerance reductions (Captan Special Review Position Document 2/3,
dated June 1985); thus, data reflecting only one of the following test regimens are required:
1. If l he registrant wishes to retain preplant, at—plant, and foliar uses, tests must include:
(i) a preplant broadcast treatment with a WP formulation at 6 lb ai/A; (ii) an at—plant
treatment using a D formulation at 6 lb ai/A; and (iii) in separate tests, multiple foli r
applications (at 4-day intervals) of a WP and, in separate tests, an EC formulation at 1.2
lb ai/lOO gal of spray and of a D formulation at 3 lb ai/A/application. A maximum gal/A
rate must be proposed for WP, F1C and EC formulations and the data requested must reflect
this rate. Samples must be obtained on the day of final treatment and data must depict
captan residues of concern. Applications are to be made using both ground and aerial
equipment. Alternatively, the registrant may propose a label amendment to omit aerial
application and submit only tests using ground equipment. The registrant must propose a
label restriction which gives the maximum number of applications allowed per season for
foliar applications; the date required above must reflect that number.
Snap bean tests should be conducted in the states of WI (36%), OR (21%), NY (15%), and MI
(7%), which collectively represent 79% of 1983 U.S. snap bean production. Dried bean
tests should be conducted in MI (29%), CA (15%), NE (14%), CO (11%), and ND (11%), which
represent -8O% of 1983 U.S. dried bean production (data from Agricultural Statistics ,
1984, pp. 151 and 256). Lima bean tests should be conducted in CA (58%), WI (9%), and
DE (7%), which represent 74% of the 1977 U.S. lima bean production (G.W. Ware and J.P.
McCollum, 1980, Producing Vegetable Crops , Interstate Printers & Publishers, Inc.,
Danville, IL, 508 pp.).
2. If the registrant wishes to cancel foliar uses and retain preplant and at—plant uses, then
only data reflecting preplant and at—plant tests described above are required and an appro-
priate tolerance revision must be proposed.
3. If the registrant wishes to cancel preplant, at—plant, and foliar treatment uses, data
depicting captan residues of concern in or on representative crops grown from treated
seed must be submitted (iiefer to the section entitled Seed Treatment for details of data
requirements) and an appropriate tolerance revision must be proposed.
71
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
158.125 Residue Chemistry (continued)
Residues must be determined in cannery residue rocessed from snap, lima, and dried beans
bearing measurable weathered residues . If residues are found to concentrate in any of these
processed products, appropriate food additive tolerances must be proposed.
2. Peas (Dry and Succulent ) — The established tolerances for captan residues in or on dry and succulent
peas cannot be evaluated, since no data depicting captan residues on or in peas were submitted. The
following data are required:
The requested test protocols recognize that the registrant(s) may seek cancellation of certain uses
of captan formulations to permit tolerance reductions (Captan Special Review Position Document 2/3,
dated June 1985); thus, data reflecting only one of the following test regimens are required:
1. If the registrant wishes to retain preplant uses, tests reflecting captan residues of concern
in or on peas (one succulent and one dried variety) following a preplant soil broadcast treatment
with a Wp formulation at 6 lb ai/A. These tests must he conducted in the states of WA (2%), WI
(27%), NM (19%), and OR (-40%), which collectively represent ‘-‘77% of 1983 U.S. pea produc
( Agricultural Statistics , 1984, p. 163).
2. If the registrant wishes to cancel preplartt uses and retain seed treatment uses, data depicting
captan residues of concern in or on representative crops grown from treated seed must be sub-
mitted (refer to the section entitled Seed Treatment for details of data requirements) and an
appropriate tolerance revision must be proposed.
3. Soybeans — The available data are sufficient to assess the adequacy of the established tolerance and
label directions, including the SLN registrations held by AR, MS, and TX. We recommend that the
entries of soybeans, succulent, and soybeans, dry, be deleted from the 40 CFR 180.103(a) because the
raw agricultural commodity of soybeans is seed. Insufficient processed product data are available
to determine whether food/feed additive tolerances are required; thus, the following additional data
are required:
Data reflecting residues in’ meal, hulls, soapstock, and crude and refined oil processed from seed
bearing measurable weathered residues. If residues are found to concentrate in any of these pro-
cessed products, appropriate food/feed additive tolerances must be proposed.
[ Note: If the . registrant elects to cancel SLN registrations for foliar use of captan formulations
on soybeans, then additional data reflecting at-plant use will be required.]
g. Foliage of Legume Vegetable Group - A crop group tolerance is not appropriate at the present time, for
the following reason:
72
-------
TABLE A
GENERIC DATA REQUIRE 4ENTS FOR CAPTAN
c158.125 Residue Chemistry (continued )
Residue data and tolerance proposals must be submitted for vines and hay of beans and peas and for
forage, hay, and straw of soybeans; alternatively a label restriction prohibiting the use of these
feed items may be proposed (refer to the following sections for details).
1. Bean Vines and Hay — No tolerances have been established or proposed and no data are available
pertaining to residues of captan in or on bean vines or hay. Since bean vines and hay are raw
agricultural commodities, tolerance proposals must be submitted; alternatively, the registrant
must propose feeding/grazing restrictions on treated crops. If the registrant elects not to
impose livestock feeding restrictions, the following data are required:
The requested test protocols recognize that the registrant(s) may seek cancellation of certain
uses of captan formulations to permit tolerance reductions (Captan Special Review Position
Document 2/3, dated June 1985); thus, data reflecting only one of the following test regimens are
required:
i. Ifthe registrant wishes to retain preplant, at—plant, and foliar uses, tests must include:
(1) a preplant broadcast treatment with a WP at 6 lb ai/A; (ii) an at-plant application of
a D formulation at 6 lb ai/A; and (iii) in separate tests, multiple foliar applications,
(at 4—day intervals) of a WP and an EC at 1.2 lb ai/lOO gal and of a D formulation at
3 lb al/A/application. The registrant must propose a maximum gal/A/application rate for
EC and WP formulations and submit data reflecting that rate. Samples must be obtained
on the day of final treatment and data must depict captan residues of concern. Applications
are to be made using both ground and aerial equipment. Alternatively, the registrant may
propose a label amendment to omit aerial application and submit only tests using ground
equipment. The registrant must propose a label restriction which gives the maximum number
of applications allowed per season for foliar applications; the data required above must
reflect that number. Snap bean tests should be conducted in the states of WS (86%), OR
(21%), NY (15%), and MI (7%), which collectively represent 79% of 1983 U.S. snap bean
production. Dried bean tests should be conducted in MI (29%), CA (15%), NE (14%), CO
(11%), and MD (11%), which represent -‘-80% of 1983 U.S. dried bean production (data from
Agricultural Statistics , 1984, pp. 151 and 256). Lima bean tests should be conducted in
CA (58%), WS (9%), and DE (7%), which represent -‘-74% of 1977 U.S. lima bean production
(G.W. Ware and J.P. McCollum, 1980. Producing Vegetable Crops , Interstate Printers &
Publishers, Inc., Danville, IL, 608 pp.).
ii. If the registrant wishes to cancel foliar uses and retain preplant and at—plant uses, then
only data reflecting preplant and at-plant tests described above are required.
73
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
c158.125 Residue Chemistry (continued )
iii. If the registrant wishes to cancel preplant, at—plant, and foliar uses and retain seed
treatment uses, data depicting captan residues of concern in or on representative crops
grown from treated seed must be submitted (refer to the section entitled Seed Treatment
for details of data requirements).
2. Pea Vines and Hay — No tolerances have been established for captan residues of concern in or on
the vines and hay of peas nor are such tolerances proposed.
The registrant must either propose feeding/grazing restrictions for treated pea vines and hay,
or propose tolerances for captan residues of concern in or on pea vines and pea hay, and support
them with the following data:
The requested test protocols recognize that the registrant(s) may seek cancellation of certain
uses of captan formulations to permit tolerance reductions (Captan Special Review Position Document
2/3, dated June 1985); thus, data reflecting only one of the following test regimens are required:
3. Soybean Forage, Hay and Straw — The registrant must either propose tolerances for captan residues
of concern in or on soybean forage, straw, and hay and provide the supporting data described below,
or must propose feeding and grazing restrictions. The available data are inadequate for tolerance
proposal, since no data reflecting at-planl application were submitted. The following data are
required:
The requested test protocols recognize that the registrant(s) may seek cancellation of certain uses
of captan formulations to permit tolerance reductions (Captan Special Review Position Document 2/3,
dated June 1985); thus, data reflecting only one of the following test regimens are required:
i. If the registrant wishes to retain preplant uses, tests reflecting captan residues of concern
in or on soybean forage, hay, and straw following a preplant soil broadcast treatment with the
5% D formulation at 6 lb ai/A. These tests should be conducted in the states of IL (16%), IN
(7.7%), IA (17%), MN (9.2%), MO (6.3%), ND (9.1%), and OH (6.5%), which collectively represent
“71.8% of U.s. 1983 soybean production ( Agricultural Statistics , 1984, p. 128). Alterna-
tively, the registrant may propose a feeding and grazing restriction.
ii. If the registrant wishes to cancel preplant uses and retain seed treatment uses, data depicting
captan residties of concern in or on representative crops grown from treated seed must be sub-
mitted (refer to the section entitled Seed Treatment for details of data requirements).
h. Fruiting Vegetable (except Cucumbers) Group — A crop group tolerance is inappropriate at the present
time for the following reason:
74
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
ç158.125 Residue Chemistry (continued )
Mditional data are required to support established tolerances for residues in or on representative com-
modities, peppers and tomatoes.
1. Eggplant - The available data are inadequate to support the established tolerance because the data
reflected only 1—2 applications whereas an unlimited number of treatments may be made, and no data
representing the 0—day posttreatment interval were submitted. However, additional data are not
required because the data requested for peppers will be translated to assess the established
tolerance for residues in or on eggplant.
2. Peppers - The available data are inadequate to support the established tolerance because (i) no data
reflected a 0-day posttreatment interval; (ii) the data reflected a limited number of applications
whereas no maximum number of applications per season is established; (iii) no recovery data were
submitted an analytical procedures (surface extraction or sample maceration) were unclear; and
(iv) geographic representation was poor. The following additional data are required:
The requested test protocols recognize that the registrant(s) may seek cancellation of certain use
of captan formulations to permit tolerance reductions (Captan Special Review Position Document, 2/3,
dated June 1985); thus, data are required from one of the following treatment regimens.
i. Ifthe registrant wishes to retain foliar uses, tests must include multiple foliar applications
with a WP formulation at 3 lb ai/A. Treatments must begin at first fruit set and continue at
3—day intervals throughout the growing season. Foliar tests should reflect 0—day posttreatment
interval. Applications must be made using both ground and aerial equipment. Alternatively,
the registrant may propose a label amendment to omit aerial applications and submit only tests
using ground equipment. Trials must be conducted in CA (31%), FL (35%), and TX (13%), since
these States represent the major U.S. pepper production areas as designated in Agricultural
Statistics , 1981, p. 180.
ii. If the registrant wishes to cancel foliar uses and retain seed treatments, data depicting
residues of concern in or on representative crops must be submitted (refer to section entitled
Seed Treatment for details of data requirements) and an appropriate tolerance revision must
be proposed.
2. ¶ftmatoes - The available data are insufficient to assess the adequacy of the established tolerance
because data reflecting a 0—day posttreatment interval were meager and geographic representation
was inadequate. Furthermore, no data were submitted concerning concentration of residues upon
processing. The following additional data are required:
75
-------
TABLE. A
GENERIC DATA REQUIREMENTS FOR CAPTAN
158.125 Residue Chemistry (continued )
The requested test protocols recognize that the registrant(s) may seek cancellation of certain uses
of captan formulations to permit tolerance reductions (Captan Special Review Position Document 2/3,
dated June 1985); thus, data reflecting only one of the following treatment regimens are required:
i. If the registrant wishes to retain foliar and preplant uses, tests must include a preplant
application with a D formulation at 7.5 lb ai/A and multiple foliar applications with a WP
and, in separate tests, a D formulation at 5 lb ai/A/application. Treatments must begin at
first fruit set and continue at 5—day intervals; samples of mature fruits must be obtained
on the day of final treatment. These dafa must depict captan residues of concern. Foliar
applications must be made using both ground and aerial equipment and greenhouse tests must
be represented. The registrant may propose a label amendment to omit aerial applications
and submit only tests using ground equipment for field tests. Tests must be conducted in
CA where -85% of tomatoes grown for processing are produced and FL where 5O% of
the U.S. fresh market tomatoes are produced ( Agricultural Statistics , 1984, p. 173).
ii. If the registrant wishes to cancel foliar uses and retain preplant use, data from tests, as
described above, reflecting preplant use only must be submitted and an appropriate tolerance
revision proposed.
iii. If the registrant wishes to cancel foliar and preplant uses and retain seed treatment uses,
data depicting captan residues of concern in or on representative commodities must be sub-
mitted (refer to section entitled Seed Treatment for details of data requirements) and an
appropriate tolerance revision must be proposed.
Data depicting residues in or on wet and dry pomace, puree, catsup and juice processed from tomatoes
bearing measurable weathered residues are required. If residues concentrate in any of these pro-
cessed commodities, appropriate food/feed additive tolerances must be proposed.
i. Cucurbit Vegetable Group — A crop group tolerance is not appropriate at the present time for the
following reasons:
Data are required for the representative crops, cantaloupes, cucumbers, and summer squash (see
Conclusions sections for these crops for details of data requirements).
Registered uses of captan formulations on cantaloupe and cucumbers (preplant, foliar, and postharvest)
are dissimilar from the registered uses on other group members (preplant and foliar only).
76
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
158.125 Residue Chemistry (continued )
1. Cucumbers — The submitted data for cucumbers do not adequately support the established tolerance
for residues of captan in or on cucumbers because: (i) the submitted foliar data are too meager;
(ii) the procedural steps (surface extraction or sample maceration) used in residue analysis were
not clarified; and (iii) no postharvest treatment data are available. The following data are
required:
The requested test protocols recognize that the registrant(s) may seek cancellation of certain
uses of captan formulations to permit tolerance reductions (Captan Special Review Position
Document 2/3, dated June 1985); thus, data reflecting only one of the following test regimens are
required:
i. If the registrant wishes to retain preplant, foliar, and postharvest uses, tests must
include: (i) a single preplant broadcast soil treatment with a WP formulation at 6 lb
ai/A, and (ii) in separate tests, multiple foliar applications at 5—day intervals with
a D formulation at 5 lb ai/A, a WP formulation at 1.5 lb ai/lOO gal or the maximum lb
ai/A rate, and an EC at 1.2 lb ai/lOO gal. A maximum lb ai/A/applicat lon rate must be
proposed for WP, F1C, and EC formulations and the requested data must reflect that rate.
Also, a maximum permissible number of applications/season or lb al/season must be proposed
and represented in the data. Samples must be obtained on the day of final foliar treatment
and treated postharvest with a WP or a PlC formulation at 1.28 lb ai/lOO gal. These data
must depict captan residues of concern. Foliar applications must be made using both
ground and aerial equipment. Alternatively, the registrant may propose a label amendment
to omit aerial applications and submit only tests using ground equipment. Tests must be
cOnducted in CA, FL, TX, and MI which account for 58% of U.S. fresh market and 38% of U.S.
processing production ( Agricultural Statistics, l981, p. 171).
ii. If the registrant elects to cancel postharvest uses and retain preplant and foliar uséis,
only data reflecting the above—described preplant and foliar treatments are required and
an appropriate tolerance reduction must be proposed.
iii. If the registrant elects to cancel postharvest and foliar uses and retain preplant uses, only
data reflecting the above—described preplant treatments are required and an appropriate
tolerance reduction must be proposed.
iv. If the registrant wishes to cancel preplant, foliar and postharvest uses and retain seed
treatment uses, data depicting captan residues of concern in or on representative crops grown
from treated seed must be submitted (refer to the section entitled Seed Treatment for details
of data requirements) and an appropriate tolerance revision must be proposed.
77
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
158.125 Residue Chemistry (continued )
2. Melons (excluding watermelons) - The available data are not adequate to support the established
tolerance for residues of captan in or on cantaloupes, honeydew melons, or muskmelons, since data
were submitted that reflect only postharvest treatment. While we consider the submitted postharvest
data adequate to describe residues resulting from this type of treatment, they are not adequate to
indicate what residues will result from foliar or preplant uses. The following data are required:
The requested test protocols recognize that the registrant(s) may seek cancellation of certain uses
of captan formulations to permit tolerance reductions (Captan Special Review Position Document 2/3,
dated June 1985); thus, data reflecting only one of the following test regimens are required:
1. If the registrant wishes to retain preplant, foliar, and postharvest uses tests must include:
(1) a single preplant broadcast soil treatment with a WP formulation at 6 lb ai/A, and (ii) in
separate tests, multiple foliar applications t 5-day intervals with a D formulation at 5 lb au
A, a WP formulation at 1.5 lb ai/100 gal or the maximum lb al/A rate and with an EC at 1.2 lb ai/
100 gal. A maximum lb ai/A/application rate must be proposed for the WP, PlC, and EC formula-
tions and the requested data must reflect that rate. Also, a maximum permissible number of
applications/season or lb al/season must be proposed and represented in the data. Samples
must be obtained on the day of final foliar treatment and treated postharvest with a WP or a
F1C formulation at 1.28 lb ai/100 gal. These data must depict captan residues of concern in
or on cantaloupes. Foliar applications must be made using both aerial and ground equipment.
Alternatively, the registrant may propose a label amendment to omit aerial applications and
submit only tests using ground equipment. Tests must be conducted in CA which accounts for
-67% of U.S. cantaloupe production ( Agricultural Statistics , 1981, p. 165).
2. If the registrant elects to cancel postharvest uses and retain preplant and foliar uses, only
data reflecting preplant and foliar treatments are required and an appropriate tolerance reduc-
tion must be proposed.
3. If the registrant elects to cancel postfiarvest and foliar uses and retain preplant use, only data
reflecting the above-described preplant treatments are required and an appropriate tolerance re-
duction must be proposed.
4. If the registrant wishes to cancel postharvest, foliar, and preplant uses and retain seed treat-
ment uses, data depicting captan residues of concern in or on representative crops grown from
treated seed must be submitted (refer to data requirements) and an appropriate tolerance revision
must be proposed.
78
-------
- TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
158.125 Residue Chemistry (continued )
We recommend that the established tolerances for muskinelons and honeydew melons be deleted, since
they are redundant with that for cantaloupes, the appropriate commodity according to Table 2 of
the EPA Residue Chemistry Guidelines.
3. Pumpkins — No data were submitted for pumpkins. Data requested for cantaloupes will be used to
assess the established tolerance.
No data were submitted for winter or summer squash. Data requested for cantaloupes and cucumbers
will be used to assess the established tolerances for residues in or on winter and summer squash,
respectively. [ Note: translated data may not be used for establishment of a group tolerance.]
4. Watermelon — The submitted data are inadequate to support the established tolerance for the residues
of captan in or on watermelons because they do not reflect a 0—day posttreatment interval or the
maximum registered use rate. Data requested for cantaloupes will be used to assess the established
tolerance for residues in or on watermelon.
j • Citrus Group - A crop group tolerance is not appropriate at the present time for the following reasons:
Additional data must be submitted to support the established tolerances for residues in or on oranges,
grapefruit, and lemons (refer to individual crop group sections for details).
The registered uses of captan formulations on oranges and tangerines (tangeloes) differ from those for
grapefruit, lemons, and limes.
1. Grapefruit — The available data are insufficient to assess the adequacy of the established interim
tolerance for residues of captan in or on grapefruit for the following reasons: Ci) no data were
submitted reflecting residues in or whole fruit following postharvest application; (ii) insufficient
data were submitted (one datum) reflecting preharvest application; and (iii) geographical representa-
tion was inadequate. The following additional data are required:
The requested test protocols recognize that the registrant(s) may seek cancellation of certai n uses
of captan formulations to permit tolerance reductions (Captan Special Review Position Document 2/3,
dated June 1985); thus, data reflecting only one of the following treatment regimens are required:
i. If registrant(s) wishes to retain tree skirt and postharvest uses, tests must include tree skirt
treatments with a WP and a D formulation (in separate tests) at 10 lb ai/A. Two applications at
10—week intervals must be made, the first before winter rains. Trees must be thoroughly wet to
a height of 4 feet. Fruit must be harvested at maturity and treated postharvest by spray and
79
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
158.125 Residue Chemistry (continued )
dip (in separate tests) with a WP or F1C formulation at 1.28 lb ai/100 gal. Data must be
conducted in FL (65%), TX (18%), or CA (12%), which collectively represent 95% of the U.S.
grapefruit production ( Agricultural Statistics , 1984, p. 200).
ii. If a the registrant wishes to cancel postharvest uses and retain tree skirt uses, then only test
reflecting postharvest treatment are required and an appropriate tolerance revision must be pro-
posed.
The registrant must propose a label amendment to delete the citrus by-product feeding restric-
tion; such a restriction is inappropriate because utilization of citrus by—products is not under
grower control.
2. Lemons — The available data are inadequate for evaluation of the established tolerance for captan
residues in or on lemons because the submitted data did not depict residues following tree skirt
applications, and postharvest treatments did not reflect the maximum registered rate. The following
additional data are required:
The requested test protocols recognize that the registant may seek cancellaiton of certain uses of
captan formulations to permit tolerance reduction (Captan Special Review Position Document 2/3, dated
June 1985); thus, data reflecting only one of the following test regimens are required.
i. If the registrant wishes to retain tree skirt and postharvest uses, tests must include tree
skirt treatment with a WP and, in separate tests, a D formulation at 10 lbs ai/A. Two appli-
cations at 10—week intervals must be made, the first before winter rains. Trees must be
thoroughly wet to a height of 4 feet. Fruit must be harvested at maturity and treated post-
harvest by spray and dip, in separate tests, with a WP or PlC formulation at 1.28 lb ai/100
gals. These da.ta must depict captan residues of concern. Tests must be conducted in AZ and
CA which provide 20% and 80% respectively, of the U.S. lemon crop (Agr. Statistics 1984,
p. 200).
ii. If the Registrant wishes to cancel postharvest uses and retain tree skirt use, then only tests
utilizing the above—mentioned tree skirt treatments must be performed and an appropriate toler-
ance revision must be proposed.
3. Limes — No data were submitted pertaining to captan residues in or on limes. However, no data are
required because the registered uses on lemons are similar to those on limes; therefore, the re-
quested data for lemons will he translated to limes.
80
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
158.125 Residue Chemistry (continued )
4. Oranges — The available daa are inadequate for evaluation of the established tolerance for captan
residues in or on oranges because the submitted data did not depict residues following tree skirt
applications, foliar tests did not reflect multiple applications, and postharvest treatents did not
reflect the maximum registered rate. Furthermore, the submitted processing studies were insufficient
to determine whether residues concentrate in processed products. The following additional data are
required:
The requested test protocols recognize that the registrant(s) may seek cancellation of certain uses
of captan formulatins to permit tolerance reductions (Captan Special Review Position Document 2/3,
dated June 1985); thus, data reflecting only one of the following test regimens are required:
1. If the registrant wishes to retain tree skirt, foliar and postharvest uses, tests must include
U) tree skirt treatments with a WP and, in separate tests, a D formulation at 10 lb al/A. Two
applications at 10—week intervals must be made, the first before winter rains. Trees must be
throughly wet to a height of 4 feet; (ii) multiple foliar applications with a WP formulation
(with and without spray sticker) at 5 lb al/A/application made between petal fall and the time
fruit is 1/2 ’ in diameter; and (iii) postharvest treatment by spray and dip, in separate
tests, with a WP or F1C formulation at 1.28 lb ai/100 gal. These data must depict captan re-
sidues of concern. Foliar application must be made using both ground and aerial equipment.
Alternatively, the registrant may propose a label amendment to omit aerial applications and sub-
mit only tests using ground equipment. The registrant must propose a label amendment which gives
the maximum number of foliar applications allowed per season; the data required above must re-
flect that number. Tests must be conducted in CA and FL which provide ‘—34% and 62%, respect-
ively, of the U.S. orange crop ( Agricultural Statistics , 1984, p. 200).
2. If the registrant(s) wishes to cancel postharvest use, and retain foliar and tree skirt uses,
then only tests utilizing the above-mentioned foliar and tree skirt treatments must be performed
and an appropriate tolerance revision msut be proposed.
3. If the registrant(s) wishes to cancel postharvest and foliar uses and retain tree skirt treat-
ments, tests must be performed utilizing the above-mentioned tree skirt tests only and an appro—
pria e tolerance revision must be proposed.
Residues of concern must be determined in dried pulp, oil, molasses, and juice processed from
oranges bearing measurable weathered residues. If residues are found to concentrate in any of
these processed products, appropriate food/feed additive tolerances must be proposed. [ Note:
this processing study will apply to all citrus crops.]
81
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAFTAN
§158.125 Residue Chemistry (continued )
The registrant must propose a label amendment to delete the citrus by—product feeding restrict—
Ofl5; such a restriction is inappropriate because utilization of citrus by—products is not under
grower control.
5. Tangerines — No data were submitted pertaining to captan residues in or on tangerines. However,
no data are required because the registered uses on oranges are similar to those on tangerines
(tangeloes); therefore, the requested data for oranges will be translated to tangerines. We re-
commend that the 40 CFR 180.103 entry for tangeloes be deleted since tangerines is considered a
general category for both tangerines and tangeloes (40 CFR 180.1).
k. Pome Fruits Group - A crop group tolerance is inappropriate at the present time for the following reason:
Additional data are required for apples and pears, the representative commodities of this group (refer
to crop sections for details).
1. Apples - The data indicate that residues will not exceed the established tolerance following post—
harvest treatment alone in accordance with registered uses. However, the data are insufficient to
assess the established tolerance for residues in or on apples because no data were submitted reflect-
ing residues from foliar applications at the maximum rate followed by postharvest treatment at the
maximum registered rate. Therefore, the following data are required:
The requested test protocols recognize that the registrant(s) may seek cancellation of certain use
of captan formulations to permit tolerance reductions (Captan Special Review Position Document 2/3,
dated June 1985). Therefore, only one of the following protocols need be addressed:
If the registrant wishes to retain foliar and postharvest uses, tests must include multiple
foliar applications with a wP and, in separate tests, a D formulation at 8 lb ai/A/application.
Treatments using an EC at 2 lb ai/100 gal must also be represented. Treatments must begin at
delayed dormant and continue at 5—day intervals through first cover, then at 7—day intervals
thereafter until harvest. Samples of mature fruits must be obtained on the day of final treat-
ment and treated postharvest with a spray or dip in a WP or F1C formulation at 1.28 lb ai/100
gal. These data must depict captan residues of concern. Applications must be made using both
ground and aerial equipment. Alternatively, the registrant may propose a label amendment to
omit aerial applications and submit only tests using ground equipment. Tests must be conducted
in WA (35%), NY (13%), MI (10%), CA (6%), PA (6%), and VA (6%), ( Agricultural Statistics , 1984,
p. 187).
82
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
158.125 Residue Chemistry (continued )
If the registrant(s) elect to cancel postharvest uses, data are required for foliar treatments,
as described above, only; an appropriate tolerance revision should be proposed.
The available processing data indicate that concentration of residues does not occur in juice,
dry pomace, or wet pomace.
2. Crabapples — Since captan is not federally registered for use on crabapples, we recommend that the
40 CFR 180.103(a) be amended by deleting the tolerance for crabapples. Alternatiely, the registrant
may propose use directions and submit appropriate supporting residue data.
3. Pears - The data indicate that residues will not exceed the established tolerance following post-
harvest treatment in accordance with registered uses. However, the data are insufficient regarding
foliar applications, or combinations of foliar and postharvest treatments for the following reasons:
(i) no data were submitted reflecting residues from foliar applications at the maximum rate; (ii) no
data were submitted reflecting residues from foliar applications at the maximum rate followed by
postharvest treatment at the maximum registered rate. The data requested for apples will be trans-
lated to assess the established tolerances covering residues in or on pears. [ It should be noted,
however, that translated data may not be used to support a crop group tolerance.]
4. Quinces — No data were submitted in support of the established tolerance for quinces. However, since
the registered foliar use on quince is similar to that on apples, the requested data for apples will
be translated to quince.
1. Stone Fruits Group - A crop group tolerance is not appropriate at the present time for the following
reasons:
The use directions are quite diverse for the commodities with registered uses in this crop group.
Data requirements to support the established tolerances for residues in or on cherries and peaches must
be satisfied.
1. Apricots - The available data do not adequately support the established tolerance for the following
reasons: (i) none of the submitted tests depicted residues following multiple applications as
allowed under the current use directions; (ii) no aerial application data were submitted; and (iii)
no tests were submitted depicting residues resulting from the registered postharvest use. Therefore,
the following data are required:
83
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
158.125 Residue Chemistry (continued )
The requested test protocols recognize that the registrant(s) may seek cancellation of some uses such
as postharvest dip or spray treatments to permit tolerance reductions (Captan Special Review Position
Document 2/3, dated June 1985). If the registrant(s) wish to retain delayed dormant, foliar, and pos
harvest uses, tests must include: multiple foliar applications with, in separate tests, a D and a
WP formulation at 5 lb ai/A and 1.5 lb ai/100 gal, respectively. Applications of all formulations
must be made in separate tests using both aerial -and ground equipment. Treatments must begin in red
bud periods and continue through cover stages; the registrant must propose a maximum seasonal use
rate and provide supporting data. Fruits must be obtained on the day of final treatment and
immediately subjected to postharvest treatment with a WP or F1C formulation applied in a dip and
as a spray (in separate tests) at 1.28 lb ai/100 gal. Data must reflect captan residues of concern.
sts must be conducted in CA where 96% of all domestic apricots are produced (Agricultural Statis-
tic, 1984, p. 193, 1983 preliminary data). Alternatively the registrant(s) may elect to cancel
certain uses. If postharvest uses are cancelled, then only foliar tests as described above are re-
quired. The registrant may propose deletion of aerial use and conduct tests with ground equipment
only. An appropriate tolerance revision should be proposed if postharvest use is cancelled.
2. Cherries — The available data are insufficient to assess the adequacy of the established tolerance
because (i) only one test represented residues following an application rate approaching or above the
maximum single use rate; (ii) none of the tests depict residues following applications with D or EC
formulations, (iii) no aerial application data were submitted; and (iv) no tests were submitted
depicting residues resulting from the registered postharvest use. The following data are required:
The requested test protocols recognize that the registrant may seek cancellation of some uses such
as postharvest dip or spray treatments to permit tolerance reductions (Captan Special Review Position
Document 2/3, dated June 1985). If the registrant wishes to retain delayed dormant/foliar and
postharvest uses, tests must include multiple foliar applications with, in separate tests, a D
formulation at 10 lb al/A/application and an EC and WP or F1C at 2 lb ai/100 gal. All tests must
reflect use of ground and aerial equipment. Treatments must begin in pink bud periods and continue
through cover stages; the registrant must begin in pink bud periods; the registrant must propose a
maximum seasonal use rate and provide supporting data. Samples of mature fruit must be obtained on
the day of final treatment and immediately subjected to postharvest treatment with a WP or F1C
formulation applied, in separate tests, in a dip and as a spray at 1.28 lb ai/100 gal. Data must
reflect captan residues of concern. sts with sour cherries must be conducted in MI (60%) and NY
(15%) and tests with sweet cherries must be conducted in MI (10%), NY (2%), OR (25%), and WA (50%)
States which represent the major cherry growing regions in the U.S. ( Agricultural Statistics , 1984,
p. 196, 1983 preliminary data). Alternatively, the registrant(s) may elect to cancel or propose
amendments to certain registered uses. If postharvest uses are cancelled, then only foliar tests
as described above are required the registrant may propose deletion of aerial use and ocnduct tests
with ground equipment only. If postharvest use is cancelled, an appropriate tolerance revision
must be proposed.
84
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
158.125 Residue Chemistry (continued )
3. Nectarines - The available data are inadequate to support the established tolerance for the following
reasons: (i) none of the tests depict residues following applications with D or EC formulations;
(ii) no aerial application data were submitted; and (iii) no tests were submitted depicting residues
resulting from the registered postharvest use. The use direction for nectarines are similar to those
for peaches. Therefore, no data will be required depicting residues of concern in or on nectarines
since, upon submission of the requested data for peaches, the data will be translated to nectarines.
4. Peaches — The available data are inadequate to support the established tolerance for the following
reasons: (i) no tests depict residues following applications of the D formulations, (ii) residue
data following aerial applications are not available, and (iii) no tests were submitted depicting
residues following the registered postharvest use. The following data are required:
The requested test protocols recognize that the registrant(s) may seek cancellation of certain uses
such as postharvest dip or spray treatments to permit tolerance reductions (Captan Special Review
Position Document 2/3, dated June 1985). If the registrant wishes to retain delayed dormant/foliar
and postharvest uses tests msut include multiple foliar applications with, in separate tests, a D
formulation at 6 lb ai/A/applicatiort and an EC formulation at 2 lb ai/100 gal; all tests must re-
flect use of ground and aerial equipment. Treatments must begin in pink bud periods and continue
through cover stages; the registrant must propose a maximum seasonal use rate and provide supporting
data. Samples of mature fruit must be obtained on the day of final treatment and immediately subject
to postharvest treatment with a WP or F1C formulation applied, in separate tests, in a dip and as
a spray at 1.28 lb ai/100 gal. Data must reflect captan residues of concern. Tests must be con-
ducted in CA (59%), GA (5%) or SC ( 5%), and PA (5%) or NJ (5%), States which represent the
major U.S. peach growing regions ( Agricultural Statistics , 1984, p. 215, 1983 preliminary data).
Alternatively, the registrant(s) may elect to cancel or propose amendments to certain registered
uses. If postharvest uses are cancelled, then only foliar tests as described above are required and
the registrant may propose deletion of aerial use and conduct tests with ground equipment only. If
the postharvest use is cancelled, then an appropriate tolerance revision must be proposed.
5. Plums (fresh prunes ) — The available data provide adequate support for the established tolerance;
however, since no processing studies concerning residues on dried prunes are available, the following
additional data are required:
Residue data for prunes dried from plums bearing measurable, weathered residues. Should residues
concentrate upon processing, an appropriate food additive tolerance must be proposed.
85
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
158.125 Residue Chemistry (continued )
m. Small Fruits and Berries Group - A crop group tolerance is not appropriate at the present time, for the
following reason:
Additional data are required for raspberries, blueberries, cranberries, grapes, and strawberries.
1. Blackberries - The existing tolerance cannot be evaluated, since no data depicting captan residues
in/on blackberries have been submitted. Requested data for raspberries will be translated to black-
berries (refer to the Raspberries section); therefore, no additional data are required for black-
berries.
2. Blueberries — The available data do not provide adequate support for the established tolerance for
captan residues in or on blueberries, since the reported data are meaqer, the majority of the data
are incomplete and/or do not reflect a 0—day posttreatment interval, no data reflect aerial appli-
cation, and captan residues found in one study reflecting a 0—day posttreatxnent interval exceeded the
established tolerance level. The following additional data are required:
Data depicting captan residues of concern in Or on blueberries, from tests reflecting multiple foliar
applications by air and (in separate tests) by ground equipment of a WP formulation at 2.5 lb ai/A.
Applications must begin at midbloom and continue at 7-day intervals until berries are mature.
Samples must be collected on the day of the final treatment. (Alternatively, if the registrant
elects to propose cancellation of the aeri al use, aerial data data need not be submitted.) These
tests should be conducted in MI (41.2%), NJ (26.1%), and ME (18.1%), which collectively represent
--85.4% of 1983 U.S. blueberry production ( Agricultural Statistics , 1984, P. 214).
3. Cranberries — The available data do not provide adequate support for the established tolerance for
captan residues in or on cranberries, since data reflecting multiple applications are meager, no data
reflect more than two treatments, no data reflect aerial application, no data reflect the use of
multiple treatments with a 0-day posttreatment interval, and geographic representation is inadequate.
The following additional data are required:
Data depicting captan residues of concern in or on cranberries, from studies reflecting delayed
dormant and multiple foliar applications of the 50% WP by ground equipment and (in separate tests)
by air at 3.5 lb ai/A. Samples must be collected on the day of the final treatment. Alternatively,
the registrant may elect to propose cancellation of aerial application, in which case aerial data
need not be submitted. These studies should be conducted in the States of MA (48.3%) and WI (37.4%),
which collectively represent 86% of 1983 U.S. cranberry production ( Agricultural Statistics ,
1984, p. 208).
86
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
158.125 Residue Chemistry (continued )
The registrant must propose a label restriction which gives the maximum number of applications
allowed per season for foliar application; the data required above must reflect that number.
4. Dewberries — The existing tolerance cannot be evaluated, since no data depicting captan residues in/
on dewberries have been submitted. Requested data for raspberries will be translated to dewberries
(refer to the Raspberries section); therefore, no additional data are required for dewberries.
5. Grapes — The available data doL not provide adequate support for the established tolerance for captan
in or on grapes, since the amount of data reflecting full-season treatment patterns, maximum reg-
istered use rates, or 0-day posttreatment intervals is inadequate, and no data reflect aerial treat-
ment. Also, data depicting residues in washed raisins do not reflect full-season treatments or
aerial applications. The following additional data are required:
Data depicting captan residues of concern in or on grapes and washed raisins from tests reflecting
the following treatment program:
1. Multiple foliar applications of a WP and an EC (in separate tests) at 1.96 at lb ai/250 gal spray
A (before bloom, immediately after bloom, and at 7-day intervals thereafter), and (in separate
tests) of a D formulation at 5 lb ai/A. Formulations must be applied by ground and (in separate
tests) by air. Samples (grapes) must be collected immediately after the last application. Re-
presentative samples should be analyzed.
2. Two postharvest applications of a WP, at 1.5 lb al/A by air, and (in separate tests) of 1 lb al/A
by ground equipment to fruit from above tests on drying trays in the field. After treatment,
raisins should be processed normally and analyzed for residues.
Tests should be conducted in CA (89.3%) and NY (3.5%), States which collectively represent
93% of the 1982 U.S. grape—growing regions ( Agricultural Statistics , 1983, p. 210).
The registrant must specify whether the “pomace” data submitted in PP#3F2898 were for wet or dry
pomace. If the data were for wet pomace, data depicting residues in dried pomace processed from
grapes bearing measurable weathered residues are required and an appropriate feed additive
tolerance proposal, if needed.
The available data indicate that captan residues concentrate in juice and raisin waste by factors
up to 2x and 8x, respectively. On receipt of the data requested above, appropriate food/feed
additive tolerances for these processed commodities must be proposed.
87
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAFTAN
158.125 Residue Chemistry (continued )
6. Raspberries - The available data do riot adequately support the established tolerance for captan
residues in or on raspberries, since the data are meager, and do not reflect multiple (more than
two) applications, sampling on the day of harvest, the use of WP or PlC formulations or the maximum
lb ai/100 gal rate. If 1.96 lb ai/100 gal are applied at 250 gal/A (maximum expected gal/A for rasp-
berries), then the maximum expected rate is -.5 lb ai/A. Therefore, the following additional data
are required:
Data depicting captan residues of concern in or on raspberries, from tests reflecting the following
full-season treatment program using a D formulation at 3 lb al/A and a WP at 5 lb ai/250 gal/A (each
in separate tests) applied by ground equipment and (in separate tests) by air; delayed dormant
application; foliar application at bloom, two weeks postblooni, 3-5 days prehaverst, midharvest, and
8—10 days postmidharvest. Samples must be collected on the day of the last treatment. Alter-
natively, if the registrant elects to propose cancellation of aerial uses, aerial data need not be
submitted. These tests should be conducted in the states of WA (51.5%) and OR (48.5%), which
collectively represent -.100% of 1983 U.S. raspberry production ( Agricultural Statistics , 1984,
p. 214).
The above requested data will also be used to evaluate the established tolerances for residues in or
on blackberries and dewberries.
7. Strawberries — The available data do not provide adequate support for the established tolerance for
captan residues in or on strawberries, since few studies reflected the use of maximum registered lb
ai/IO0 gal (1.96) use rates for WP formulations, and none reflected maximum use rates for Ds or ECs.
Purtherinore, residue levels were found to approach tolerance levels in several studies reflecting the
use of rates as low as O.31x the maximum use rate, and postreatment intervals greater than 0 days.
The following data are required:
Data depicting captan residues of concern in or on strawberries, from tests reflecting the following
full—season treatment program (samples must be collected immediately after the last treatment).
1. Delayed dormant application by air or (in separate tests) by ground equipment of a Wp and EC
formulation at 5 lb a i/250 gal/Aand (in separate tests), a D formulation at 5 lb al/A.
ii. Multiple foliar applications using the foriau ations and use rates listed under (1.) above.
(Alternatively, if the registrant elects to propose cancellation of aerial uses, aerial data
need not be submitted.) These tests should be conducted in the States of CA (70%) and OR
(8.9%), which collectively represent 79% of 1983 U.S. strawberry-growing regions ( Agricultural
Statistics , 1984, p. 227).
88
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
158.125 Residue Chemistry (continued )
The registrant must propose a label restriction which gives the maximum number of foliar appli-
cations allowed per season; the data required above must reflect that number.
n. Tree Nuts Group — A crop group tolerance is inappropriate at the present time for the following reasons:
No data have been submitted for pecan or English walnut, representative commodities of this group.
Additional data are required for almonds, a representative commodity of this group.
1. Almonds — The available data are insufficient to assess the adequacy of the established tolerances
because data reflecting the maximum application rate were not submitted. The following data are re-
quired:
Data reflecting residues of concern in or on almond nutineats and almond hulls resulting from
multiple applications with either a WP or a F1C formulation at 16 lb ai/A/application. Treatments
must take place at delayed dormant, popcorn, bloom, and petal fall, and at regular intervals there-
after up to 12 days prior to harvest. Applications must be made using both ground and aerial equip-
ment, in separate tests. Alternatively, the registrant may propose a label amendment to omit aerial
applications and submit tests using ground equipment only. Tests must be conducted in CA, where
virtually all domestic almonds are produced ( Agricultural Statistics , 1984, p. 237).
We recommend that the registrant propose a label amendment deleting the feeding restriction on almond
hulls treated later than 5 weeks after petal fall, as this commodity is not under grower control.
o. Cereal Grains Group - A crop group tolerance is inappropriate at the present time for the following
reasons:
No data or registered use (other than seed treatment) exist for rice, sorghum, and wheat, representative
commodities of this group.
Additional data are required for corn, a representative commodity of this group.
1. Corn — The available data are insufficient to assess the adequacy of the established tolerance for
residues in or on sweet corn because data reflecting soil or foliar applications were not submitted.
The following data are required:
The requested test protocols recognize that the registrant(s) may seek cancellation of soil and/or
foliar use of captari formulations to permit tolerance reductions (Captan Special Review Position
89
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
158.125 Residue Chemistry (continued )
Document 2/3, dated June 1985); thus, data reflecting only one of the following treatment regimens
are required;
i. If the registrant wishes to retain foliar and preplant uses, a maximum gal/A or lb al/A rate
must be proposed for the foliar use and the 50% WP must be applied accordingly using aerial and
ground equipi ent (in separate tests) 10 days prior to harvest. All tests must include preplant
soil treatment of the 50% WP or 5% D formulations at 6 lb ai/A. Alternatively, the registrant
may propose a label amendment to omit aerial applications and submit foliar tests using ground
equipoent only. Samples must be analyzed for all captan residues of concern. Tests must be
conducted in NY (11%), OH (8%), CA (7%), and FL (28%) which represent the major fresh market
production regions and WI (25%) and WA (15%) which represent the major production regions for
processing ( Agricultural Statistics , 1984, p. 158).
ii. If the registrant wishes to cancel foliar use and retain preplant soil treatment use, mature
sweet corn from geographic regions specified above must be harvested from tests in which the
50% WP or 5% D formulation was applied as a preplant soil treatment at 6 lb ai/A. An appro-
priate tolerance reduction should be proposed.
iii. If the registrant wishes to cancel preplant and foliar uses and retain seed treatment uses,
data depicting captan residues of concern in or on representative crops grown from treated seed
must be submitted (refer to the section entitled Seed Treatment for details of data require-
ments) and an appropriate tolerance revision must be proposed.
Also, no data were submitted concerning concentration of residues in the processed product of sweet
corn, cannery waste. The following data are iequired:
Residues of concern in cannery waste processed from sweet corn bearing measurable weathered residues.
If concentrations of any residues of concern is found to occur, a suitable feed additive tolerance
must be proposed.
The data are insufficient to assess the established tolerance for residues in or on detreated seed
corn because no data were submitted depicting residues resulting from detreated seed that originally
had been treated at the maximum allowable rate. The following data are required:
90
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
c158.125 Residue Chemistry (continued )
Residues of concern in or on corn seed treated (in a slurry) with a WP, D, or F1C formulation at
3.76 oz ai/lOO lbs seed, and detreated by an acceptable process. Data must depict residues of
concern both before and after detreating. If different methods of detreating are to be permitted,
data must be presented depicting residues resulting from each method. Data must depict the in-
fluence of varying parameters of the detreating process, such as rate of seed treatment, volume
of water required, temperature employed, etc. These data are to be used to establish the accept-
able conditions for detreating by each process. A mechanism should be implemented to prevent the
feeding of detreated seed which contain residues of pesticides in addition to those of captan.
p. Herbs and Spices Group — A crop group tolerance is inappropriate at the present time for the following
reasons:
Tolerance proposals for dill and parsley are currently under review and no data have been submitted
or tolerances established or proposed for other crop group members.
1. Diii — No conclusions may be made at the present time since the petition for use on dill is
currently pending. -
2. Parsley — No conclusion may be made at the present time since the petition for use on parsley
is currently pending.
3.’ Avocado — No data were submitted to support the established tolerance for residues of captan in
or on avocados. The following additional data are required:
The requested test protocols recognize that the registrant(s) may seek cancellation of foliar
use of captan formulations to permit tolerance reductions (Captan Special Review P9sition
Document 2/3, dated June 1985); thus, data reflecting only one of the following treatment regimens
are required:
i. If the registrant wishes to retain foliar use, data reflecting captan residues of concern
must be provided from avocados harvested on the same day as the last of multiple foliar
applications, using a WP at 1 lb/lOO gal/application (the registrant must propose a
maximum seasonal use rate and submit data accordingly). Separate tests mqst be conducted
utilizing aerial and ground (high and low volume) equipment. Alternatively, the registrant
may propose deletion of the aerial use from label directions and submit only tests using
ground equipment. The foliar tests must be conducted in CA and FL, which respectively
represent 89 and ll% of the U.S. avocado production regions ( Agricultural Statistics ,
1984, p. 194)
91
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
158.125 Residue Chemistry (continued )
ii. Should the registrant elect to cancel foliar application of captan to avocado, and retain
seed treatment use, further data reflecting seed treatment may be required (refer to section
entitled Seed Treatment for details of data requirements I
r. Mangoes — No data were submitted to support the established tolerance for residues of captan in or on
mangoes. The following additional data are required:
The requested test protocols recognize that the registrant(s) may seek cancellation of certain uses
of captan formulations to permit tolerance reductions (Captan Special Review Position Document 2/3,
dated June 1985); thus, data reflecting only one of the following treatment regimens are required:
If the registrant wishes to retain foliar and postharvest uses, tests must include multiple foliar
applications with a WP formulation at 10 lb al/A per application. Mangoes must be harvested on the
day of last application and immediately treated postharvest with a WP or F1C formulation at 1.28 lb
ai/l0O gal in separate dip and spray tests. These data must depict captan residues of concern.
Foliar application must be made using (in separate tests) appropriate aerial and ground (high and
low volume) equipment. Alternatively, the registrant(s) may propose a label amendment to omit
aerial application, and submit only tests using ground equipment. The registrant must proposed
maximum seasonal application rate for foliar treatments and submit data accordingly. Tests must
be conducted in FL which accounts for 92% of the U.S. production area of mangoes (Census of
Agriculture 1983, p. 193).
s. Cottonseed — The available data are insufficient to assess the established tolerance for residues of
captan in or on cottonseed for the following reasons: (i) residue data did not reflect maximum per-
missible application for at—plant treatment; (ii) analysis for residues was not performed on whole
cottonseed; (iii) geographical representation was poor; and (iv) insufficient data were submitted
reflecting concentrations of residues in processed products of cottonseed. Furthermore, since
forage is a raw agricultural commodity of cotton, either residue data must be submitted and a
tolerance proposed, or a feeding restriction must be proposed. The following data are required:
The requested test protocols recognize that the registrant(s) may seek cancellation of certain uses
of captan formulations to permit tolerance reductions (Captan Special Review Position Document 2/3,
dated June 1985); thus, data reflecting only one of the following treatment regimens are required:
i. If registrant(s) wish to retain at—plant (preplant) use of captan on cotton, tests must
be performed utilizing a D formulation at 6 lb al/A. Residue data must depict captan
residues of concern in or on cottonseed and cotton forage. A tolerance for captan
residues of conern in or on cotton forage must be proposed; alternatively, the registrant
may propose feeding and grazing restrictions. Tests must be conducted in MS (15%), TX
(23%), and CA (26%), since these states represent the major u.s. cotton growing regions
( Agricultural Statistics , 1984, p. 63).
92
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
158.125 Residue Chemistry (continued )
ii. If the registrant(s) wishes to cancel preplant uses and retain seed treatment uses, data
depicting captan residues of concern in or on representative, crops grown from treated seed
must be submitted (refer to the section entitled Seed Treatment for details of data require-
ments) and an appropriate tolerance revision must be proposed.
Data depicting residues of concern in cottonseed processed products including meal, hulls, soapstock,
crude oil, refined oil processed from cottonseed bearing measurable, weathered residues. Should
concentration of residues be found to occur upon processing, then appropriate food/feed additives
must be proposed.
t. Kiwi — No conclusions may be made at the present time since the petition for kiwi fruit is currently
pending.
u. Pineapple - The available data are insufficient to assess the adequacy of the established tolerance
because no data reflecting captan residues in or on whole fruit were presented and no date reflected
postharvest treatments. Furthermore, no data were available concerning residues in or on pineapple
forage or in pineapple processed products (bran and juice). Since pineapple forage is a raw agricul-
tural product of pineapple, a tolerance proposal and supporting data must be submitted; alternatively,
the registrant may propose a feeding restriction. The following additional data are required:
The requested test protocols recognize that the registrant(s) may seek cancellation of certain uses
of captan formulations to permit tolerance reductions (Captan Special Review Position Document 2/3,
dated June 1985); thus, data reflecting only one of the followinq treatment regimens are required:
i. If the registrant wishes to retain preplant, foliar and postharvest uses, data must be
submitted depicting captan residues of concern in or on pineapple treated once preplant
(as pineapple slips) and serveral times foliarly (ground equipment only) with the 50% WP.
Preplant dip treatment is to be at 5 lb ai/100 gal and foliar treatments are to be at 2
lb ai/lOO gal. The registrant must propose a maximum number of foliar treatments and
submit data accordingly. Pineapples must be harvested on the day of last foliar appli-
cation and subsequently given a postharvest application of 5 lb ai/l0O gal, as a wash,
and in separate tests, a dip. Foliar tests must be conducted in HI, which accounts for
—99% of the U.S. pineapple production area of the U.S. (Census of Agriculture, 1978,
p. 204).
ii. If the registrant(s) wishes to cancel postharvest use, and retain preplant and foliar use,
tests must be performed utilizing above—mentioned preplant and foliar treatments and an
appropriate tolerance revision must he proposed.
93
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
158.125 Residue Chemistry (continued )
iii. If the registrant(s) wishes to cancel foliar and postharvest use and retain preplant use, then
tests must be performed utilizing above-mentioned preplant tests and an appropriate tolerance
revision must be proposed.
Registrant must provide residue data for the RAC pineapple forage from the above tests, and propose
a tolerance or propose appropriate feeding restrictions.
Residue data must be provided for bran and pineapple juice processed from pineapple bearing
measurable, weathered residues. If residues are found to concentrate upon processing, then
appropriate food/feed additive tolerances must be proposed.
v. Seed Treatments — Since l 4 C-residues are taken up into pods, stems and leaves of soybean grown from
seed treated with ( 14 C]captan (refer to Nature of the Residue in Plants; MRID 00083100), seed treatment
must be considered a food use. Thus, all raw agricultural commodities of crops having seed treatment
as a registered use of captan must have tolerances for residues of captan. The available data are
adequate for cotton seed and corn seed only; following seed treatment at maximum rates, no measurable
residues were found in or on these commodities. The data for soybeans, oats, and wheat are not
adequate because rates well below the maximum permissible rates were used. The following data are
required:
Representative commodities from the nongrass animal feeds; cereal grains; forage, fodder, and straw
of cereal grains; and grass forage, fodder, and hay crop groups are given in 40 CFR 180.34 and the
individual crops, flax, lentils, okra, peanuts, radishes, rape, sunflower, sugar beets, safflower,
sesame, and Swiss chard must be seed-treated with captan according to the label directions of the
product having the maximum permissible use rate. In many cases, the maximum rate is present on a
multiple active ingredient formulation label. Samples of all raw agricultural commodities from
each crop must be collected at the shortest interval after planting in which they could be used
for food or feed purposes. Analyses should be made for all residues of concern. Tolerances
reflecting maximum expected residue levels or, if no measurable residues are detected, at the
limit of detection must be proposed.
The Special Report procedures for captan may result in cancellation of many uses on crops having
tolerances for residues of captan. However, we expect that seed—treatment uses may not be cancelled
(Captan Special Review Position Document 2/3, June 1985). If all uses, with the exception of
seed treatment, are cancelled for any of the crops for which tolerances exist (see list under Use
Directions and Limitations), seed treatment data collected according to the procedures outlined
above will be required for those crops, or representative crops in each crop group. In such cases,
appropriate tolerance revisions (reductions) must be proposed at the time of the data submission.
94
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN
158.125 Residue Chemistry (continued )
w. Food Packing Boxes — No data are available to support the food additive regulation for captan as a
surface treatment on paper and paperboard for use in contact with food. Also, no data are available
regarding the use of captan to surface—treat food packing boxes. Therefore, the following data are
required:
The registrant is referred to 21 CFR 176.170(c) and (d) for data requirements regarding the use
of captan as a surface treatment of paper and paperboard. All of the test procedures in Table 2
(section C) for food types I, II, and VIB must be completed using methods described in section d
following surface treatment of paper and paperboard with captan at 0.225% retention, based on
weight of the sheet, using the 75% WP formulation. No end test is required for food type VIII
(dry solids with the surface containing no free fat or oil). However, 21 CFR 176.180(a) states
that the “stthstances” (1 .e., captan) must be “used in amounts not to exceed that required to
accomplish their intended physical or technical effect, and are so used as to accomplish no
effect in food other than that ordinarily accomplished by packaging.”
All labels (50—80% WP) permitting treatment of food “packing boxes” must be amended with a restriction
permitting use on boxes used to pack fruits and vegetables having esablished tolerances for residues
of captan only. Furthermore, if these tolerances (or proposed tolerance revisions) are set to cover
seed treatment or preplant use only, data are required to verify that residues resulting from treat-
ment of packing boxes will not result in tolerance—exceeding values.
x. Meat, Milk, Poultry and Eggs — The maximum expected dietary intake of captan residues by beef cattle
is 139 ppm up to 14 days prior to slaughter and 128 ppm for the 14 days prior to slaughter if the
diet consisted of 20% bean cannery residue, 10% wet grape pomace, 30% cull potatoes, and 40% detreated
corn seed up to 14 days prior to slaughter and 20% bean cannery residue, 10% wet grape pomace, 30%
cull potatoes, 25% almond hulls, and 15% dry beans for the 14 days prior to slaughter. The maximum
expected intake by dairy cattle is 139 ppm based on the diet described above that included detreated
corn grain. For hogs, the maximum expected intake up to 14 days prior to slaughter is 124 ppm based
on a diet consisting of 10% bean cannery residue, lO% wet grape pomace, 50% cull potatoes and 30%
detreated corn seed and 99 ppm for the 14 days prior to slaughter based on a diet consisting of 10%
bean cannery residue, 10% wet grape pomace, 50% cull potatoes, 20% dry beans, and 10% dry soybeans.
The maximum expected intake by turkeys and broilers is 19 ppm based on a diet consisting of 3% wet
grape pomace, 5% dry grape pomace, 5% dehydrated apple pomace, 7% cull potatoes, 10% dry beans, 20%
soybeans, 30% soybean meal, 10% dry peas, and 10% cottonseed meal. For laying hens, the maximum
expected intake is 34 ppm based on a diet of 3% wet grape pomace, 5% dry grape pomace, 5% pineapple
bran, 20% cull potatoes, 15% dry beans, 50% dry soybeans, and 2% soybean meal.
95
-------
TABLE A
G NERIC DATA REQUIREMENTS FOR CAPTAN
§158.125 Residue Chemistry (continued )
[ The contributions to the diet by wet grape pomace, cull potatoes, and bean cannery residue were
corrected for dry matter percentages of 37%, 23%, and 9.4%, respectively. Thus, tolerances for
residues in or on these commodities were multiplied by 2.7, 4.3, and 10.6, respectively, prior
to determining their contribution of residues to the animal’s diet. It should be noted, however,
that data gaps exist for several feed commodities (refer to “Magnitude of the Residue in Plants”);
thus, these “maximum expected intake” levels are subject to change.]
Presently, the nature of the residue in plants and animals is not adequately understood. On
receipt of the data requested in the sections entitled •‘Nature of the Residue in Plants,” “Nature
of the Residue in Animals,” and “Magnitude of the Residue in Plants,” the adequacy of the residue
data for animal products will be assessed and the adequacy of established tolerances for residues
in animal products determined. Also, at that time pertinent sample storage and storage stability
information for animal commodities will be required since such information is either inadequate or
lacking at the present time.
96
-------
TABLE A
GENERIC U tTA REI UIREMENI’S fOR CAFTAN
§158.125 Residue Chemistry (continued )
1/ Ccinposition: IGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabeleci;
TEP = l ypical end-use product; EP = End—use product.
2/ Data* must be subnitted no later than 24 rronths from the date of receipt of this Standard.
3/ Data reflecting the distribution and metabolism of carbonyl—labeled ( 14 C) captan in lettuce following fuliar
treatments, and in potato tubers following fuliar and postharvest treatments. Application rates must be
sufficiently high to permit complete 14 C—residues identification. Data reflecting the metabolism of 14 C—
labeled trichlorcr thyl this moiety of the captan molecule in potato tubersand lettuce. Note: Samples fran
the metabolism studies requested above must also be analyzed using enforcement methods to ascertain method
validity.
4/ Metabolism studies utilizing poultry. Animals must be dosed for three days with carbonyl-labeled ( 14 C)
captan at a concentration in the total diet which will result in sufficient residues in the tissues and eggs
for characterization. Animals must be sacrificed within 24 hours of the final dose (eggs rmist be collected
twice daily). 14 C—Residues must be characterized in muscle, fat, kidney, liver, and eggs. Data reflecting
the metabolism of 14 C—labeled trichioro methyl this moiety (side chain) of captan molecule in ruminants and
chickens. Note: Samples fran-the metabolism studies requested above must also be analzed using enforcement
methods to ascertaib method validity.
5/ Method trials must be conducted to evaluate the CC methods given in MRID 00025123 for determination of captan
residues in animal tissues, eggs, and mild. F’or enforcement purposes, Method I in PAM, Vol. II, Pesticide
Reg. Sec. 180 .130 is acceptable for plant commodities.
The nature of residues in plant and animals has not been adequately described. If additional metabolites of
concern are detected in plants and/or animals products, the conclusions stated above may be changed.
* Required data, excluding the data required under the April 29, 1985, Section 3 (c)(2)(B), “Special Data
Call—In—Notice on Captan and Its Metabolites for Residue Chemistry and Toxicology” notice. The schedule
for submitting those data is not changed by this Standard.
97
-------
TABLE A
GENERIC DATA RE) U I RE 4ENTS FOR CAFTAN
§158.125 Residue Chemistry (continued )
6/ The storage stability of captan residues in or on animal and plant tissues is not adequately understood. The
follo iing additional data are required:
The stDrage intervals and conditions of storage of samples used to support all established tolerances for
residues must be submitted. These data must be accompanied by data deputing the percent decline in
residues at the tii es and under the conditions specified. On receipt of these data, the adequacy of the
aforen ntioned tolerances will be reevaluated.
All residue data requested in this standard must be accompanied by data regarding storage length and
conditions o storage of samples analyzed. These data must be accompanied by data depicting the
stability of residues under the conditions and for the tima intervals specified.
7/ conclusion can be made because a petition for residues in or on this raw agricultural connodity is pending
with the EPA.
8/ There was federally registed use for this conirrodity. The tolerance must deleted or the use the crop must be
registered.
98
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAN 92% TEcHNIcALa; (EP ’ REG. NO. 32691-1; CALHIO CHEMICALS, INC.)
Does EPA
Have Data
Must Additional
Data Requirement
Compositlonb
to
Satisfy This
Requirement?
Bibliographic
Citation
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?C
158.120 Product Chemistry
Product Identity and Composition:
61—1 — Product Identity and Disclosure
of Ingredients
TGAI
Yes
61—2 — Description of Beginning Mate-
No
rials and Manufacturing Process
TGAI
No
61-3 — Olscuss lon of Formation of Im-
Yes
purities
1GM
No
Analysis and Certification of Product
Yes
Ingredients
62—1 — Preliminary Analysis of Product
Samples
1GM
No
62—2 — Certification of Ingredient Lim-
Yes
its
1GM
62—3 — Analytical Methods to Verify
Partially
Registration jacket
Yes
Certified Limits
TGAI
Physical and Chemical Characteristics
TGAI
Partially
Yes
Registration jacket
Yes
63—2 — Color
63—3 — Physical State
TGAI
Yes
Registration jacket
No
63—4 - Odor
1GM
Registration jacket
No
63—5 — Melting Point
TGAI
No
Yes
63—6 — Boiling Point
TGAI
N,Ae
Yes
63—7 — Density, Bulk Density, or
Specific Gravity
TGAI
Partially
Registration jacket
Yes
° The 92% technical serves as a manutacturlng—use product.
b Composition: TGAI = technical grade of the active ingredient.
C Data iwst be submitted no later than € months from the date of this Standard.
d Information obtained from desk references.
e Not required because the technical is a solid at room temperature.
99
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAF’TAN 92% IEcHNIcALa;
(EPA REQ. NO. 32691-1; CALH!O CHEMICALS 1 INC.)
Does EPA
Must Additional
Have Data to
Data Be Submitted
Data Requirement
Comp sitionb
Satisfy This
Requirement?
Bibliographic
Citation
Under FIFRA Section
3(c)(2)(B)?c
158.120 Product Chemistry (continued)
63—8 — Solubility
TGAI
Yes
Registration jacket
No
63—9 — Vapor Pressure
63—10 — Dissociation Constant
PAL
PA!
Yes
N/Ad
00098845
No
No
63—11 — Octanol/Water Partition
Coefficient
PAL
No
Yes
63—12 — ph
TGAI
Partially
Registration jacket
Yes
63—13 — Stability
Other Requirement:
64—1 — Submittal of Samples
TGAI
N/A
Partially
N/A
Registration jacket
Yes
Ihe 9 % technical serves as a rnanutacturing-use product
b Composition: TGAI = technical grade of the active ingredient; PA! = pure active Ingredient.
C Data must be submitted no later than 6 months from the date of this Standard.
d Not required because the active ingredient is not an acid or base.
100
-------
TABLE D
GENERIC DATA REQUIREMENTS FOR CAPTAN 90% FORMULATION INTERMEDIATEa; (EPA REG. NO. 239—2351;
CO.)
CHEVRON CHEMICAL
Does EPA
Have Data to
Must Additional
Data Requirement
Compositionb
Satisfy This Bibliographic
Requirement?e Citation
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?C
158.120 Product Chemistry
Product Identity and Composition:
61—1 — Product Identity and Disclosure
of Ingredients
MP
Yes
61—2 — Description of Beginning Mate-
No
rials and Manufacturing Process
MP
No
61—3 — Discussion of Formation of Im—
Yes
.pur lt les
NP
No
Analysis and Certification of Product
Yes
Ingredients
62—1 — Preliminary Analysis of Product
Samples
NP
No
62—2 — Certification of Ingredient Lim-
Yes
its
NP
Partially Registration
62—3 — Analytical Methods to Verify
Yes
Certified Limits
NP
Partially 00098862;
Other Requirements:
64—1 — Submittal of Samples
N/A
jacket
N/A
Yes
No
—.
manufact uring—use
Ihe 9O formulation intermediate serves as a
b Conpositlon: NP Manufacturing—use product.
C Data must be submitted no later than 6 months from the date of this Standard.
d Information obtained form desk references.
e Data requirements pertain to the basic formulation and the alternate formulation (refer to Confidential
Appendix B).
101
-------
The 92% technical serves as a manutacturing—use product.
Composition: TGAI = technical grade of the active ingredient.
Data nust be submitted no later than Ł months from the date of this Standard.
Information obtained from desk references.
Not required because the technical is a solid at room temperature.
TABLE E
GENERIC DATA REQUIREMENTS FOR CAPTAN 92% TEcHNLcALa; (EPA REG. NO. 239—1246; CHEVRON CHEMICAL CO.)
Does EPA
Have Data
Must Additional
Data Requirement
Compositionb
Satisfy This
Requirement?
Bibliographic
Citation
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?C
158.120 Product Chemistry
TGAI
Yes
Product Identity and Composition:
61—1 — Pcoduct Identity and Disclosure
of Ingredients
61—2 — Description of Beginning Mate-
No
rials and Manufacturing Process
TGAI
Partially
61—3 — Discussion of Formation of Im-
Yes
purities
TGAI
No
Analysis and Certification of Product
Yes
Ingredients
62—1 — Preliminary Analysis of Product
.
Samples
TGAI
No
62—2 — Certification of Ingredient Lirn-
Yes
Its
TGAI
Partially
62—3 — Analytical Methods to Verify
Registration jacket
(es
Certified Limits
TGAI
Partially
00098862
Physical and Chemical Characteristics
TGAI
Yes
Yes
63—2 — Color
63—3 — Physical State
TGAI
Yes
00098893
No
63—4 — Odor
1GM
No
00098893
No
63—5 — Melting Point
1GM
No
Yes
63—6 - Boiling Point
1GM
N/As
Yes
63- 7 — Density, Bulk Density, or
Specific Gravity
1GM
Partially
Registration jacket
Yes
d
b
C
c i
e
102
-------
the 9 % technical serves as a manufacturing—use proiuct
Composition: TGAI = technical grade of the active ingredient; PA! = pure active ingredient.
Data must be submitted no later than 6 months from the date of this Standard.
Not required because the active Ingredient is not an acid or base.
TABLE E
GENERIC DATA REQUIREMENTS FOR CAPTAN 92% TECHNICALa; (EPA REG. NO. 239-1246; CHEVRON CHEMICAL CO.)
Does EPA
Have Data to
Must Additional
Data Requirement
Composi ionb
Satisfy This
Requirement?
Bibliographic
Citation
Data Be Submitted
tinder FIFRA Section
3(C)(2)(B)?C
158.120 Product Chemistry (continued)
63—8 — Solubfl lty
TGA!
No
63—9 — Vapor Pressure
63—10 — Dissociation Constant
PA!
PA!
Yes
N/Ad
-Yes
No
63—11 — Octanol/Water Partition
No
Coefficient
PA!
No
63—12 — pH
TGAI
No
Yes
63-13 — Stability
TGAI
Partially
00098893
Yes
Other Requirement:
64-1 — Submittal of Samples
N/A
N/A
Yes
U
b
C
d
103
-------
TABLE F
GENERIC DATA REQUIREMENTS FOR CAt’TAN 45% FORMULATION INTERMEDIATEa (EPA REG. NO. 239-2367;
CO.)
CHEVRON CHEMICAL
Does EPA
Have Data to
Must Additional
Data Requirement
Compositionb
Satisfy This
Requirement?
Bibliographic
Citation
Data Be Submitted
Under FIFRA Section
3(c)(2.)(B)?C
158.120 Product Chemistry
Product Identity and Composition:
61—1 — Product Identity and Disclosure
of Ingredients
MP
Yes
d
61—2 — Description of Beginning Mate-
No
rials and Manufacturing Process
MP
No
61—3 — Discussion of Formation of Im-
Yes
purities
MP
No
Analysis and Certification of Product
Yes
Ingredients
62—1 — Preliminary Analysis of Product
,
Samples
MP
No
62-2 — Certification of Ingredient Lim-
Yes
its
MP
Partially
62—3 — Analytical Methods to Verify
Registration jacket
Ye
• Certified Limits
Other Requirements:
4—1 — Submittal of Samples
MP
N/A
Partially
N/A
00098862
Yes
No
—.
manufacturing—use
a me q5 formulation intermediate serves asa
b Composition: MP = Manufacturing—use product.
C Data must be submitted no later than 6 months from the date of this Standard.
d Information obtained from desk references.
104
-------
TABLE G
GENERIC DATA REQUIREMENTS FOR CAPTAN 80% FORMULATION INTERMEDIATEa (EPA REG. NO. 239—2058;
CO.)
CHEVRON CHEMICAL
Does EPA
Have Data
Must Additional
Data Requirement
Compositionb
to
Satisfy This
Requirement?
Bibflographic
Citation
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?C
158.120 Product Chemistry
HP
Yes
——d .
Product Identity and Composition:
61—1 — Product Identity and Disclosure
of Ingredients
61—2 — Description of Beginning Mate—
No
rials and Manufacturing Process
HP
No
61—3 — Discussion of Formation of Im-
Yes
purities
MP
No
Analysis and Certification of Product
Yes
Ingredients
62—1 — Preliminary Analysis of Product
Samples
HP
No
62—2 — Certification of Ingredient Lim—
Yes
Its
HP
Partially
62—3 — Analytical Methods to Verify
Registration jacket
Yes
Certified Limits
MP
Partially
Other Requirements:
64-1 — Submittal of Samples
N/A
N/A
00098862
Yes
No
“ - manufacturing-use product.
The m formulation intermecilate serves as
b Composition: HP = Manufacturing—use product.
C Data must be submitted no later than 6 months from the date of this Standard.
d Information obtained from desk references.
105
-------
TABLE H
GENERIC DATA REQUIREMENTS FOR CAP FAN 80% FORMULATION INTERMEDIA rEa (EPA REG. NO. 239-2411;
CO.)
CHEVRON CHEMICAL
Does EPA
Must Additional
Data Requirement
.
ComposItlonb
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?C
158.120 Product Chemistry
Product Identity and Composition:
61—1 — Product Identity and Disclosure
of Ingredients
61—2 — Description of Beginning Mate-
Yes
No
rials and Manufacturing Process
MP
61—3,— Discussion of Formation of Im-
No
Yes
purities
MP
Analysis and Certification of Product
No
Yes
Ingredients
62—1 — Preliminary Analysis of Product
Samples
MP
62—2 - Certification of Ingredient Lim-
No
Yes
its
MP
62—3 — Analytical Methods to Verify
Partially
Registration jacket
Yes
Certified Limits
MP
Other Requirements:
64—1 — Submittal of Samples
N/A
Partially
N/A
00098862
Yes
No
--
a The 80% formulation lntermeaiate Serves as
b Conposition: MP = Manufacturing_use product.
C Data must be submitted no later than 6 months from the date of this Standard.
d Information obtained from desk references.
e Data requirements pertain to the basic formulation and the alternate formulations (refer to Confidential
Appendix B).
O6
-------
GENERIC DATA REQUIREMENTS FOR CAPTAN 90% FORMULATION
CO.)
TABLE I
INTERMEDIATEa (EPA REG. NO. 239—829;
CHEVRON CHEMICAL
Does EPA
Must Additional
Have Data to
Data Be
Data Requirement
Composltionb
Satisfy This
Requirement?
Bibliographic
Citation
Submitted
Under FIFRA Section
3(C)(2)(B)?C
158.120 Product Chemistry
Product Identity and Composition:
MP
Yes
No
61—1 — Product Identity and Disclosure
of Ingredients
61—2 — Description of Beginning Mate-
rials and Manufacturing Process
MP
No
Yes
61—3 — Discussion of Formation of Im-
purities
MP
No
Yes
Analysis and Certification of Product
Ingredients
62—1 — Preliminary Analysis of Product
Samples
MP
No
Yes
62—2 — Certification of Ingredient Lim-
its
MP
Partially
Registration jacket
Yes
62-3 — Analytical Methods to Verify
Certified Limits
MP
Partially
00098862
-Yes
Other Requl rements:
64—1 — Submittal of Samples
N/A
N/A
No
manufacturing—use product.
d The formulation intermediate serves as a
b Composition: MP = Manufacturing—use product.
C Data must be submitted no later than’6 months from the date of this Standard.
d Information obtained from desk references.
107
-------
TABLE J
GENERIC DATA REQUIREMENTS FOR CAPtAN 90% FORMULATION INTERMEDIATEa (EPA REG. NO. 239—2137;
CO.)
CHEVRON CHEMICAL
Does EPA
,
Have Data
Must Additional
Data Requirement
Cornposftionb
to
Satisfy This
Requirement?
Bibliographic
Citation
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?C
158.120 Product Chemistry
Product Identity and Composition:
MP
Yes
61—1 — Product Identity and Disclosure
of Ingredients
61—2 — Description of Beginning Mate-
No
rials and Manufacturing Process
MP
No
61—3 — Discussion of Formation of Im-
Yes
purities
MP
No
Analysis and Certification of Product
Yes
Ingredients
62—1 — Preliminary Analysis of Product
Samples
MP
No
62—2 — Certification of Ingredient Lim-
Yes
its
MP
62—3 Analytical Methods to Verify
Registration jacket
Yes
Certified Limits
MP
Other Requirements:
64—1 — Submittal of Samples
N/A
N/A
00098862
Yes
No
- a manufacturing—use product.
a 90% formulatIon intermediate serves as
b Composition: MP = Manufacturing-use product.
C Data nust be submitted no later than 6 - months from the date of this Standard.
d Information obtained from desk references.
108
-------
TABLE K
GENERIC DATA REQUIREMENTS FOR CAPTAN 90% FORMULATION INTERMEDJATEa (EPA REG. NO. 239-2388;
CO.)
CHEVRON CHEMICAL
Must Additional
Data Requirement
Compositlonb
to
Satisfy This
Requirement?
Bibliographic
Citation
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?C
158.120 Product Chemistry
MP
Yes
Product Identity and Composition:
61—1 — Product Identity and Disclosure
of Ingredients
61-2 — Description of Beginning Mate-
No
rials and Manufacturing Process
MP
No
61—3 — Discussion of Formation of Im-
Yes
purities
MP
No
Analysis and Certification of Product
Yes
Ingredients
62—1 — Preliminary Analysis of Product
Samples
MP
No
62—2 — Certification of Ingredient Lim-
Yes
its
MP
62—3 — Analytical Methods to Verify
Registration jacket
Yes
Certified Limits
MP
Partially
00098862
Other Requirements:
64—1 — Submittal of Samples
N/A
N/A
Ye
-
No
--
The 90% formulatIon intermediate serves as a
Conposition: MP = Manufacturing—use product.
Data must be submitted no later than 6 months from the date of this Standard.
Information obtained from desk references.
Data requirements pertain to the basic formulation and the alternate formulation (refer to Confidential
Appendix B).
b
c
d
e
109
-------
TABLE I
GENERIC DATA REQUIREMENTS FOR CAI TAN 92% FORMULATION INTERMEDIATEa (EPA REG. NO. 239—2396;
CO.)
CHEVRON CHEMICAL
Does EPA
Must Additional
Data Requirement
Compositionb
Have Data to
Satisfy This
Requirement?
Bibliographi 9
Citation //
Data Be Submitted
Under FIFRA Section
3(c)(2)
-------
GENERIC DATA REQUIREMENTS FOR CAPTAN 90% FORMULATION
CO.)
TABLE M
INTERMEDIATEa (EPA REG. NO, 19713—107; DREXEL CHEMICAL
Does EPA
Have Data to
Must Additional
Data
Data Requirement
Composltlonb
Sat}sfy This
Requirement?
Bibliographic
Citation
Be Submitted
Under FIFRA Section
3(C)(2)(B)?C
158.120 Product Chemistry
MP
i
I
Yes
No
Product Identity and Composition:
61—1 — Product Identity and Disclosure
of Ingredients
61—2 — Description of Beginning Mate-
rials and Manufacturing Process
MP
No
Yes
61—3 — Discussion of Formation of Im-
purities
MP
No
Yes
Analysis and Certification of Product
Ingredients
62-1 — Preliminary Analysis of Product
.
Samples
MP
No
Yes
62—2 — Certification of Ingredient Lim-
its
MP
Partially
Registration Jacket
Yes
62—3 — Analytical Methods to Verify
Certified Limits
MP
No
Other Requirements:
64—1 — Submittal of Samples
N/A
N/A
No
product.
The 90% formulation intermediate serves as a
b Composition: MP = Manufacturing—use product.
C Data liust be submitted no later than 6 months from the date of this Standard.
d Information obtained from desk references.
ill
-------
TABLE N
GENERIC DATA REQUIREMENTS FOR CAP’tAN 1% FORMULATION INTERMEDIATEa (EPA REG. NO. 4816—325;
CORPORATION).
FAIRFIELD AMERICAN
EPA
Have Data
Must Additional
Data Requirement
Compositjonh
to
Satisfy This
Requirement?
Bibliographic
Citation
Data Be Submitted
Under FIFRA Section
3(c)(2 )(B)?C
158.120 Product Chemistry
MP
Yes
Product Identity and Composition:
61—1 — Product Identity and Disclosure
of Ingredients
61—2 - Description of Beginning Mate-
No
rials and Manufacturing Process
MP
No
61—3 — Discussion of Formation of Im-
Yes
purities
NP
No
Analysis and Certification of Product
Yes
Ingredients
62—1 — Preliminary Analysis of Product
Samples
NP
No
62—2 — Certification of Ingredient Lim-
Yes
its
NP
62—3 — Analytical Methods to Verify
Partially
Registration jacket
Yes
Certified Limits
NP
No
Other Regui rements:
64—1 — Submittal of Samples
N/A
N/A
Yes
No
- -
C The 1% formulation intermediate serves as a
b Composition: MP = Manufacturing—use product.
C Data must be submitted no later than 6 months from the date of this Standard.
d Information obtained from desk references.
112
-------
TABLE 0
GENERIC DATA REQUIREMENTS FOR CAPTAN 2.5% FORMULATION INTERMEDIATEa (EPA REG. NO. 4816—411;
CORP.)
FAIRFIELD AMERICAN
Does EPA
Have Data to
Must Additional
,Data Requirement
Compositionb
Satisfy This
Requirement?
Bibliographic
Citation
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?C
158.120 Product Chemistry
MP
Yes
.._d
Product Identity and Composition:
61—1 — Product Identity and Disclosure
of Ingredients
61—2 — Description of Beginning Mate-
No
rials and Manufacturing Process
MP
No
61—3 — Discussion of Formation of Im-
Yes
purities
MP
No
Analysis and Certification of Product
Yes
red lents
62—1 — Preliminary Anal.ysls of Product
Samples
MP
No
62—2 — Certification of Ingredient Lim-
Yes
its
MP
Partially
Registration jacket
62—3 — Analytical Methods to Verify
Yes
Certified Limits
MP
No
Other Requirements:
64-1 — Submittal of Samples
N/A
N/A
- Yes
No
- a manufacturing—use product.
d The formulation intermediate serves as
b Composition: MP = Manufacturing—use product.
C Data must be submitted no later than 6 months from the date of this Standard.
d Information obtained from desk references.
113
-------
TABLE P
GENERIC DATA REQUIREMENTS FOR CAPTAN 92% TECHNICALa; (EPA REG. NO. 7501—24; GUSTAFSON, INC.)
‘
Does
Have
Must Additional
Data Requirement
Composltionb
Data to
Satisfy This
Requirement?
Bibliographic
Citation
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?C
158.120 Product Chemistry
Product Identity’ and Composition:
TGAI
Yes
61—1 — Product Identity and Disclosure
of Ingredients
61—2 — Description of Beginning Mate-
No
rials and Manufacturing Process
TGAI
No
61—3 — Discussion of Formation of Im-
Yes
purities
TGAI
No
Analysis and Certification of Product
Yes
Ingredi ents
62—1 — Preliminary Analysis of Product
Samples
62—2 — Certification of Ingredient urn-
1GM
No
/
Yes
Its
1GM
//
62—3 — Analytical Methods to Verify
Partially
Registration jacket
Yes
Certified Limits
1GM
No
Physical and Chemical Characteristics
TGAI
Yes
63-2 — Color
63—3 — Physical State
TGAI
No
No
Yes
63-4 — Odor
TGAI
Yes
63-5 — Melting Point
TGAI
No
No
Yes
63—6 — Boiling Point
1GM
N/As
Yes
63—7 — Density, Bulk Density, or
Specific Gravity
IGAI
No
Yes
The 92% technical serves as a manufacturing—use product.
b Composition: 1GM = technical grade of the active ingredient.
C Data must be submitted no later than 6 months from the date of this Standard.
d Information obtained from desk references.
e Not required because the technical Is solid at room temperature.
114
-------
TABLE P
GENERIC DATA REQUIREMENTS FOR CAPTAN 92% TEcHNIcALa; (EPA REG. NO. 7501—24; GUSTAFSON, INC.)
the 9 % technical serves as a manufacturrng—use product
Composition: 1GM = technical grade of the active ingredient; PA! pure active Ingredient.
Data must be submitted no later than 6 months from the date of this Standard.
Not required because the active ingredient is not an acid or base.
Does EPA
Must Additional
Have Data to
Data Be Submitted
Data Requirement
Compositionb
Satisfy This
Requirement?
Bibliographic
Citation
Under FIFRA Section
3(c)(2)(B)?c
158.120 Product Chemistry (continued)
63—8 — So lubiHty
TGAI
No
Yes
.63—9 — Vapor Pressure
63-10 — Dissociation Constant
PA!
PA!
Yes
N/Ad
No
No
63—11 — Octanol/Water Partition
Coefficient
PAL
No
Yes
63-12 — pH
TGA!
No
Yes
63—13 — Stability
TGA!
No
Yes
Other Requi rement:
64—1 — Submittal of Samples
N/A
N/A
a
b
C
d
115
-------
TABLE Q
GENERIC DATA REQUIREMENTS FOR CAPTAN 90% FORMULATION INTERMEDIATEa (EPA REG. NO. 45115—11; IDA, INC.)
Does EPA
Have
Must
Additional
to
Satisfy This
Data Recluirement compositionb Requirement?
Bibliographic
Citation
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?C
158.120 Product Chemistry
Product Identity and Composition:
61—1 — Product Identity and Disclosure
of Ingredients tIP Yes No
61—2 — Description of Beginning Mater-
ials hand Manufacturing Process NP No Yes
61—3 — Discussion of Formation of Im-
purities NP No Yes
Analysis and Certification of Product
Ingredients
62—1 — Preliminary Analysis of F roduct
Samples NP No Yes
62—2 — Certification of Ingredient Lim-
its NP Partially Registration jacket Yes
62—3 — Analytical Methods to Verify
Certified Limits NP No Yes
Other Requirements :
64—1 — Submittal of Samples N/A N/A No
d The 90% formulation Intermediate serves as a manufacturing—use product .
b Composition: MP = Manufacturing—use product.
C Data must be submitted no later than 6 months from the date of this Standard.
d Information obtained from desk references.
116
-------
The O,b formulation Intermediate serves as
Composition: MP = Manufacturing—use product.
Data must be submitted no later than 6
Information obtained from desk references.
TABLE R
GENERIC DATA REQUIREMENTS FOR CAPTAN 0.5% FORMULATION INTERMEDIATEa (EPA REG. NO. 1021-610;
KING CO.)
MCLAUGHLIN GORMLEY
Does EPA
Have Data to
Additional
Data Requirement
Compositlonb
Satisfy This
Requirement?
Bibliographic
Citation
Be Submitted
Under FIFRA Section
3(c)(2)(B)?C
158.120 Product Chem1str
Product Identity and Composition:
MP
Yes
No
61—1 — Product identity and Disclosure
of Ingredients
61—2 — Description of Beginning Mate-
rials and Manufacturing Process
MP
No
Yes
61—3 — Discussion of Formation of Im-
purities
MP
No
Yes
Analysis and Certification of Product
Ingredients
2—l — Preliminary Analysis of Product
Samples
MP
No
Yes
62—2 — Certification of Ingredient Lim-
its
MP
Partially
Registration jacket
Yes
62—3 — Analytical Methods to Verify
Certified Limits
MP
No
Other Requirements:
— Submittal of Samples
N/A
N/A
Yes
No
a
b
c
d
a manufacturing—use product.
months from the date of this Standard.
fl7
-------
The 9 % technical Is not a registered manufacturing—use product.
Composition: TGAI = technical grade of the active ingredient.
Data must be submitted no later than 6 months from the date of this Standard.
Information obtained from desk references.
Not required because the technical is a solid at room temperature.
TABLE S
GENERIC DATA REQUIREMENTS FOR CAPTAN 92% TECHNIcALa; (UNREGISTERED; MAKHTESHIM CHEMICAL WORKS, LTD.)
Does EPA
Must
Have Data to
Data
Data Requirement
Conipositionb
Satisfy This
Requirement?
Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?C
158.120 Product Chemistry
TGAI
Yes
No
Product Identity and Composition:
61—1 — Product Identity and Disclosure
of Ingredients
61—2 — Description of Beginning Mate-
rials and Manufacturing Process
TGAI
Partially
00098845 Yes
61—3 — Discussion of Formation of Im-
purities
TGAI
No
Yes
Analysis and Certification of Product
Ingredients
62—1 — Preliminary Analysis of Product
Sampl.es
1GM
No
Yes
62—2 — Certification of Ingredient Lim-
its
TGAI
Partially
Re9istratlon jacket Yes
62—3 — Analytical Methods to Verify
for EPA Reg. No. 11678—1
Certified Limits
TGAI
Partially
00098746; 00098741; Yes
Physical and Chemical Characteristics
Registration jacket for
EPA Reg. No. 11618—12
63—2 — Color
TGAI
Yes
00098746
63—3 — Physical State
TGAI
Yes
No
00098746 No
63—4 — Odor
TGAI
No
63—5 — Melting Point
TGAI
Yes
Yes
00098746 No
63—6 — Boiling Point
TGAI
N,Ae
No
63—7 — Density, Bulk Density, or
Specific Gravity
1GM
Yes
00098845 No
a
b
C
d
E
118
-------
TABLE S
GENERIC DATA REQUIREMENTS FOR CAPTAN 92% TEcHNIcALa;
(UNREGISTERED; MAKHTESHIM CHEMICAL WORKS, LTD.)
Does EPA
Must Additional
Have Data to
Data Be Submitted
Data Requirement
Con 1 positionb
Satisfy This
Requirement?
Bibliographic
Citation
Under FIFRA Section
3(c)(2)(B)?C
158.120 Product Chemistry (continued)
63-8 — Solubility
TGAI
Partially
00098746
Yes
63-9 — Vapor Pressure
63—10 — Dissociation Constant
PA!
PA!
Yes
N/Ad
00098845
No
No
63—11 — Octanol/Water Partition
Coefficient
PA!
No
Yes
63-12 — pH
TGAI
No
Yes
63—13 — Stability
TGA!
No
Yes
Other Requirement:
64—1 — Submittal of Samples
N/A
N/A
The 9?Z technical is not a registered manütacturing—use product.
b Composition: TGA! = technical grade of the active ingredient; PA! = pure active ingredient.
C Data must be submitted no later than 6 months from the date of this Standard.
d Not required because the active ingredient is not an acid or base.
119
-------
TABLE I
GENERIC DATA REQUIREMENTS FOR CAPrAN 90% FORMULATION INTERMEDIATEa; EPA REG. NO. 11678—1; MAKHTESHIM CHEMICAL
WORKS LTD.)
Does EPA
Have Data
Must Additional
Data Requirement
Compositionb
Satisfy This
Requirement?
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?C
158.120 Product Chemistry
Product Identity and Composition:
61—1 — Product Identity and Disclosure
of Ingredients .
NP
Yes
61—2 — Description of Beginning Mate-
.
No
rials and Manufacturing Process
NP
N
61—3 — Discussion of Formation of Im-
Yes
purities
MP
No
Analysis and Certification of Product
Yes
Ingredients
62—1 — Preliminary Analysis of Product
Samples
NP
No
62—2 — Certification of Ingredient Lim-
.
Yes
Its
NP
Partially
62—3 — Analytical Methods to Verify
Registration jacket Yes
Certified Limits
Other Requirements:
64—1 — Submittal of Samples
NP
N/A
Partially
N/A
00098746; 00098741; Yes
Registration j f’ket
for EPA Reg. No. 11678—12
No
—.
manufacturing-use
° me 9U formulation intermediate serves as a
b Composition: MP = Manufacturing—use product.
c Data must be submitted no later than 6 months from the date of this Standard.
d Information obtained from desk references.
120
-------
TABLE U
GENERIC DATA REQUIREMENTS FOR •CAPTAN 74% FORMULATION INTERMEDIATEa (EPA REG. NO. 11678—2; MAKHTESH!M CHEMICAL
WORKS, LID).
Does EPA
Must Additional
Have Data to
Data Be Submitted
Data Requirement
Compositionb
Satisfy This
Requirement?
Bibliographic Under FIFRA Section
Citation 3(C)(2)(B)?C
158.120 Product Chemistry
MP
Yes
No
Product Identity and Composition:
61—1 — Product Identity and Disclosure
of Ingredients
61—2 — Description of Beginning Mate-
rials and Manufacturing Process
MP
No
Yes
61—3 — Discussion of Formation of Im-
purities
MP
No
Yes
Analysis and Certification of Product
Ingredients
62—1 — Preliminary Analysis of Product
Samples
MP
No
Yes
62—2 — Certification of Ingredient Lim-
its
MP
Partially
Registration jacket Yes
62—3 — Analytical Methods to Verify
Certified Limits
MP
Partially
00098746; 00098741; Yes
Other Requirements:
Registration jacket
for EPA Reg. No. 11678—12
64—1 - Submittal of Samples
N/A
N/A
Na
-
manufacturing-use product.
° Ihe /4 formulation Intermediate serves as a
b Composition: tip = Manufacturing—use product.
C Data mist be submitted no later than C months from the date of this Standard.
d Information obtained from desk references.
121
-------
TABLE V
GENERIC DATA REQUIREMENTS FOR CAPTAN 81% FORMULATION INTERMEDIATEa (EPA REG. NO. 11678-15;
WORKS, LID).
MAKHTESHIM CHEMICAL
Does EPA
Have Data
Must Additional
Data Requirement
Compositionb
to
Satisfy This
Requirement?
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?C
158.120 Product Chemistry
Product Identity and Composition:
MP
Yes
61—1 — Product Identity and Disclosure
of Ingredients
61—2 — Description of Beginning Mate-
No
rials and Manufacturing Process
MP
No
61—3 — Discussion of Formation of Im-
Yes
purities
MP
No
Analysis and Certification of Product
Yes
Ingredients
62—1 — Preliminary Analysis of Product
Samples
MP
No
62—2 — Certification of Ingredient Lim-
Yes
its
MP
Partially
62—3 — Analytical Methods to Verify
Registration jacket Yes
Certified Limits
MP
Partially
Other Requirements:
00098746; 00098741; Yes
Registration jacket for
EPA
64—1 — Submittal of Samples
N/A
N/A
Reg. No. 11678-12
No
-
a The SI% tormulatlon intermediate serves as a
b Composition: MP Manufacturing—use product.
C Data must be submitted no later than 6 months from the date of this Standard.
d Information obtained from desk references.
122
-------
TABLE W
GENERIC DATA REQUIREMENTS FOR CAPTAN 76% FORMULATION INTERMEDIATEa (EPA REG. NO. l1678—& MAKHTESHIM CHEMICAL
WORKS, LID).
Does EPA
Have Data to
Must Additional
Data
Data Requirement
Compositlonb
Satisfy This
Requirement?
Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?C
158.120 Product Chemistry
Product Identity and Composition:
61—1 — Product Identity and Disclosure
of Ingredients
MP
Yes
No
61—2 — Description of Beginning Mate-
rials and Manufacturing Process
HP
No
Yes
61—3 — Discussion of Formation of Im-
purities
MP
No
Yes
Analysis and Certification of Product
Ingredients
62—1 — Preliminary Analysis of Product
• Samples
MP
No
Yes
62—2 — Certification of Ingredient Lim-
its
MP
Partially
Registration jacket Yes
62-3 - Analytical Methods to Verify
Certified Limits
MP
Partially
00098746; 00098741; Yes
Other Requirements:
Registration jacket
for EPA Reg. No. 11678—12
64—1 — Submittal of Samples
N/A
N/A
No
manufacturing-use product.
a Ilie /b% formulation intermediate serves as a
b Composition: MP = Manufacturing—use product.
C Data nust be submitted no later than 6 months from the date of this Standard.
d Information obtained from desk references.
123
-------
TABLE X
GENERIC DATA REQUIREMENTS FOR CAPTAN 76% FORMIJI..ATION INTERMEDIATEa (EPA REG. NO. 11678-14;
WORKS, ITO).
MAKFITESHIM CHEMICAL
Does EPA
Have Data
Must Additional
Data Requirement
Compositlonb
to
Satisfy This
Requirement?
Data Be Submitted
Bibliographic Under FIFRA Section
Citation
158.120 Product Chemistry
Product Identity and Composition:
61—1 — Product Identity and Disclosure
of Ingredients
MP
Yes
....d
61—2 — Description of Beginning Mate-
No
rials and Manufacturing Process
MP
No
61—3 — Discussion of Formation of Im-
Yes
purities
MP
No
Analysis and Certification of Product
Yes
Ingredients
62—1 — Preliminary Analysis of Product
Samples
HP
No
62—2 — Certification of Ingredient Lim-
Yes
its
HP
Partially
62—3 — Analytical Methods to Verify
Registration jacket Yes
Certified Limits
HP
Partially
Other Requirements:
•
00098741; Yes
Registration jacket for
EPA
64—1 — Submittal of Samples
N/A
N/A
Reg. 11678—12
No
- manufacturing—use product.
a Thi iö formulation intermediate serves as a
b Composition: MP = Manufacturing—use product.
C Data must be submitted no later than 6 months from the date of this Standard.
d Information obtained from desk references.
124
-------
TABLE V
GENERIC DATA REQUIREMENTS FOR CAPTAN 83%FORMULATION INTERMEDIATEa (EPA REG. NO. 11678—12; MAKHTESHIM CHEMICAL
WORKS, LID).
d The 83% formulation Intermediate serves as a
b Composition: MP = Manufacturing—use product
C Data must be submitted no later than 6
d Information obtained from desk references.
Does EPA
Must Additional
Have Data to
Data Be Submitted
Data Requirement
Compositionb
Satisfy This
Requirement?
Bibliographic
Citation
Under FIFRA Section
3(c)(2)(B)?c
158.120 Product Chemistry
NP
Yes
No
Product Identity and Composition:
61—1 — Product Identity and Disclosure
of Ingredients ‘
61—2 — Description of Beginning Mate-
rials and Manufacturing Process
NP
No
Yes
61—3 — Discussion of Formation of Im-
purities
NP
No
Yes
Analysis and Certification of Product
Ingredients
62—1 — Preliminary Analysis of Product
Samples
MP
No
Yes
62—2 — Certification of Ingredient Lim-
its
NP
Partially
Registration jacket
Yes
62-3 — Analytical Methods to Verify
Certified Limits
NP
Partially
00098746; 00098741;
Yes
Other Requirements:
64—1 — Submittal of Samples
N/A
N/A
Registration jacket
No-
manufacturing—use product.
months from the date of this Standard.
125
-------
TABLE 1
GENERIC DATA REQUIREMENTS FOR CAPTAN 86% FORMULATrON INTERMEDIATEa (EPA REG. NO. 11678-9;
WORKS, LID).
MAKHTESHIM CHEMICAL
Does EPA
Must Additional
Have Data to
Data Be Submitted
Data Requirement
Compositlonb
Satisfy This
Requirement?
Bibliographic Under FIFRA Section
Citation 3(C)(2)(B)?C
158.120 Product Chemistry
tip
Yes
.._d No
Product !dentIty and Composition:
61—1 — Product Identity and Disclosure
of Ingredients
61-2 — Description of Beginning Mate-
rials and Manufacturing Process
tiP
No
Yes
61—3 — Discussion of Formation of Im-
purities
tiP
No
Yes
Analysis and Certification of Product
Ingredients
62—1 — Preliminary Analysis of Product
Samples
MP
No
Yes
62-2 — Certification of Ingredient Lim-
its
MP
Partially
Registration jacket Yes
62—3 — Analytical Methods to Verify
Certified Limits
MP
Partially
00098746; 00098741; Yes
Other Requirements:
Registration jacket for
EPA Reg. No. 11678—12
64—1 — Submittal of Samples
N/A
N/A
No
-
manufacturing—use product.
a The 86% formulation intermediate serves as a
b Composition: MP = Manufacturing—use product.
C Data irust be submitted no later than 6 months from the date of this Standard.
d Information obtained from desk references.
126
-------
Does EPA
Must Additional
Have Data to
Data Be Submitted
Data Requirement
Compositionb
Satisfy This
Requiremen.t?
Bibliographic
Citation
Under FIFRA Section
3(c)(2)(B)?C
158.120 Product Chemistry I
Product Identity and Composition:
I
TGAI
Yes
No
61—1 — Product Identity and Disclosure
of ingredients
61—2 — Description of Beginning Mate-
rials and Manufacturing Pro.cess
TGAI
No
Yes
61—3 — Discussion of Formation of Im-
purities
1GM
No
Yes
Analysis and Certification of Product
Ingredients
62—1 — Preliminary Analysis of Product
Samples
TGAI
No
Yes
62—2 — Certification of Ingredient Lim-
its
TGAI
Partially
Registration jacket
Yes
62—3 — Analytical Methods to Verify
Certified Limits
TGAI
Partially
00044657; 00098798;
Registration jacket
Yes
Physical and Chemical Characteristics
TGAI
Yes
Registration jacket
No
63—2 — Color
63—3 — Physical State
TGAI
Yes
Registration jacket
No
63—4 - Odor
TGAI
No
Yes
63—5 — Melting Point
1GM
No
.Yes
63—6 — Boiling Point
TGAI
N,Ae
63—7 — Density, Bulk Density, 1 or
Specific Gravity
IGA!
Partially
Registration jacket
Yes
Ihe 9 % technical serves as a manufacturing—use product.
Composition: TGAI = technical grade of the active ingredient.
Data must be submitted no later than 6 months from the date of this
Information obtained from desk references.
Not required because the technical is a solid at room temperature.
TABLE AA
GENERIC DATA REQUIREMENTS FOR CAPTAN 92% TECHNICALa; (EPA REG. NO. 476—2099; STAUFFER CHEMICAL CO.)
0
b
C
d
e
Standard.
127
-------
TABLE AA
GENERIC DATA REQUIREMENTS FOR CAPTAN 92% TEcHNIcALa; (EPA REG. NO. 476—2099; STAUFFER
CHEMICAL CO.).
Does .EPA
Have Data
Must Additional
Data Requirement
Compositionb
to
Satisfy This
Requirement?
Bibliographic
Citation
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?C
158.120 Product Chemistry (continued)
63—8 — Solubility
TGAI
Yes
63—9 — Vapor Pressure
63—10 — Dissociation Constant
PAl
PAl
Yes
N/Ad
Registration jacket
No
No
63—11 — Octanol/Water Partition
No
Coefficient
PA!
No
63—12 — pH
TGAI
No
Yes
63—13 — Stability
TGA!
Partially
Yes
Other Regul rement:
64—1 — Submittal of Samples
N/A
N/A
Registration jacket
Yes
d The 92% t chn1caI serves as a manufacturing—use product.
b Composition: TGAI technical grade of the active Ingredient; PA! = pure active Ingredient.
C Data must be submitted no later than 6 months from the date of this Standard.
d Not required because the active Ingredient is not an acid or base.
128
-------
TABLE BB
GENERIC DATA REQUIREMENTS FOR CAPTAN 90% FORMULATION INTERMEDIATEa (EPA REG. NO. 416—2100;
CO.).
STAUFFER CHEMICAL
Does EPA
Must Additional
Have Data to
Data Be Submitted
Data Requirement
.
Compositionb
Satisfy This.
Requirement?
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?C
158.120 Product Chemistry
I
NP
Yes
No
Product Identity and Composition:
61—1 — Product Identity and Disclosure
of Ingredients
61—2 — Description of Beginning Mate-
rials and Manufacturing Process
NP
No
Yes
61—3 — Discussion of Formation of Im-
purities
MP
No
Yes
Analysis and Certification of Product
Ingredi ents
62—1 — Preliminary Analysis of Product
Samples
NP
No
Yes
62—2 — Certification of Ingredient Lim-
its
NP
Partially
Registration jacket Yes
62—3 — Analytical Methods to Verify
Certified Limits
Other Requirements:
MP
Partially
00044657; 00098798; Yes
Registration jacket for
EPA Reg. No. 476-2099
64—1 — Submittal of Samples
N/A
N/A
No
manufacturing-use product.
•d The 90% formulatIon intermediate serves as a
b Composition: MP = Manufacturing—use product.
C Data rmist be submitted no later than 6 months from the date of this Standard.
d Information obtained from desk ‘references.
129
-------
TABLE
GENERIC DATA REQUIREMENTS FOR CAPTAN 80% FORMULATION
CO.).
CC
INTERMEDIATEa (EPA REG. NO. 476—2119;
STAUFFER CHEMICAL
Does EPA
Have Data to
Must Additional
Data Requirement
Compositionb
Satisfy This
Requirement?
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?C
158.120 Product Chemistry
MP
Yes
Product Identlt and Composition:
61—1 — Product Identity and Disclosure
of Ingredients
61—2 — Description of Beginning Mate-
No
rials and Manufacturing Process
MP
No
61—3 — Discussion of Formation of Im-
Yes
purities
MP
No
Analysis and Certification of Product
Yes
Ingredients
62—1 — Preliminary Analysis of Product
Samples
MP
No
6 -2 — Certification of Ingredient Lim-
Yes
its
MP
Partially
Registration
62—3 — Analytical Methods to Verify
jacket Yes
Certified Limits
MP
Partially
00044657;
Other Requirements:
Yes
Registration jacket for
EPA No. 476—2099
•
64—1 — Submittal of Samples
N/A N/A
No
- manufacturing—use product.
d formulation Intermediate serves as a
b Composition: MP = Manufacturing—use product.
C Data nust be sampled no later than 6 months from the date of this Standard.
d Information obtained from desk references.
130
-------
IV. SUBMISSION OF REVISED LABELING
Note : This section applies to all products.
FIFRA 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 CFR 162.10 (see
Appendix IV—1 ) and are surn arized for products containing
this active ingredient as jart of this Guidance Document
(See Appendix IV—2). Applications submitted in response to
this notice must include draft labeling for Agency review.
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 FIFRA sec. 6(b)(1).
A. Label Contents
40 CFR 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 tlistributor 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—l. [ 40 CFR
162.10(d)]
131
-------
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
Req. 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—l.
[ 40 CFR 162.10(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 Libel or immediate container.
It must also appear on the wrapper i 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—l. [ 40 CFR 162.10(f)]
Item 6A. INGREDIENTS STATEMENT — An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement rnu . st 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—l. [ 40 CFR
162.10 (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 Signal Word “Keep Out of Reach
on Front Panel Minimum Type Size of Children”
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
“Keep Out of Reach of Children” must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. See Appendix IV—1.
[ 40CFR162.lO(h)(l)(jj)]
132
-------
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—l.
[ 40 CFR 162.10 (h)(l)(i)J
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 ppear in immediate proximity to
the word POISON. See Appendix Iv—l. [ 40 CFR 162.lO(h)(l)(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—l. [ 40 CFR 162.l0(h)(1)(iii)]
Item 7E. REFERRAL STATEMENT — Th 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.
SeeAppendixlV—l. [ 40 CFR162.lO(h)(l)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING — The
precautionary statements listed below must appear together
on the label under the heading “PRECAUTIONARY STATEMENTS.”
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. See Appendix IV—l. [ 40 CFR 162.10
(h) (2)1.
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, i njury or damage. See Appendix IV—l. [ 40 CFR 162.10
(h) (2) (i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non—target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. See Appendix IV—1. [ 40 CFR
162 .10 (h) (2) (ii)]
133
-------
Item 8C. PHYSICAL OR CHEMICAL HAZARD
1. Flammability statement . Precautionary statements relating
to flammability 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—flammability. The
following criteria will be used t 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°F (177°C).
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
iii. 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 flammability, 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.
134
-------
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 162.11(c). You will be notified of
the Agency’s classification decision.
Classification Labeling Requirements
If 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 CFR 162.lO(h)(l)(iv)
b. Directly below this statement on the front panel,
a summary statement of the terms of restriction must
appear (including the reasons for restriction if
specified in Section I). It 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:
135
-------
a. You may label the product for Restricted use.
If you do so, you may include on the label uses that
are unrestricted, but. you may not distinguish them
on the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may “split” your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
Item 9B [ There is no Item 9B]
Item 9C. 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 1OA. 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 lOB [ There is no Item lOB]
Item bC. 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, IV—5, and IV—6 to determine the storage and disposal
instructions appropriate for your products.
Item 1OD. 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 pe ticide. 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—l. [ 40 CFR 162.10 1
136
-------
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.
137
-------
V. INSTRUCTIONS FOR SUBMISSION
A. For Manufacturing Products (MP) containing (name of
pesticide) as sole 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 ot this section the “FIFRA Section
3(c)(2)(B) Summary Sheet” EPA Form 8580—1. Refer to Appendix
11—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 111—1
C. Two copies of any required product—specific data
(See Tables B).
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 jndication 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)(1)(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 any
test is delayed or aborted so that the agreed schedule cannot be
1 38
-------
met, notify the Product Manager and the Office of Compliance
Monitoring.
B. For Manufacturing Use Products containing (name of pesticide)
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 11—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 (name of pesticide) alone
or 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, t ’ EPA Form
8580—1. Refer to Appendix 11—3 with appropriate attachmeri s.
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 111—1), if applicable (if Table C lists required
product—specific data).
1 39
-------
c. Two copies of any required product—specific data,
if applicable (if Table C lists 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. 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.
3. Within the time frames set forth in Table A , submit all
generic data, unless you are eligible for the formulator’s
exemption.
D. For intrastate products containing (name of pesticide)
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. Addresses
Applications and other required information should be
submitted to the following address:
Product Manager
Registration Division (TS—767C)
Office of Pesticide Programs
Environmental Protection Agency
401 NI St., SW.
Washington, D.C. 20460
Phone No. (703)
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
140
-------
Appendix 11—1
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 OF ENTRY. The unit of entry in this bibliography
is called a “study. t ’ 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 OF ENTRIES. The entries in this bibliography
are sorted numerically by ‘Master Record Identifier,” or
MRID, nurhber. 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 1 4(d)( 1 4) below for a further explana-
tion. En 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 jo be used whenever specific reference is needed.
LI. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
141
-------
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 Jrom 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
1n 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, petit1on 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.
( ) 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 nui iber Is in turn
followed by an alphabetic suffix which sI ws the
relative position of the st iy within the volune.
Fbr exanpie, within accession rnznber l23L 56 3 the
first sttziy u1d be l23L 56—A; the second, 123L 56—
B; the 26th, 123456—Z; and the 27th, l23Z 56—AA.
142
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Captan Standard
MRID CITATION
00002875 Frear, D.E.H.; Boyd, J.E. (1967) Use of Daphnia magna for the
microbioassay of pesticides: I. Development of standardized
techniques for rearing Daphnia and preparation of dosage-mor-
tality curves for pesticides. Journal of Economic Entomology.
60(5):1228—1236. (Also in unpublished submission received
May 11, 1977 under 239—2458; submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:230225—A)
00002927 Devine, J.M.; Horton, W.E. (1972) Determination of Captan N-Tn-
chloromethylrnercapto_4_cyclohexene_1,2,...dlcarboximjde in Cot-
tonseed: Report No. 120. (Unpublished study received on unknown
date under 0F0939; prepared by State Univ. College——Oswego, Lake
Ontario Environmental Laboratory, submitted by Uniroyal Chemi-
cal, Bethany, Conn.; CDL:094582—A)
00002928 Uniroyal Chemical (1972) Residues in PPM: Vitavax. (Unpublished
study received on unknown date under 0F0939; CDL:094582-B)
00003025 Chevron Chemical Company (1977) Residue Chemistry Data to Support
the Label Registration f Orthocide—Vitavax 20—20 Seed Protect—
ant. Includes method RM—IF—1 dated Jun 25, 1976 entitled:
Determination of Captan residues in crops. (Unpublished Study
received May 11, 1977 under 239-2458; CDL:230222-A)
00020560 Schafer, E.W. (1972) The acute oral toxicity of 369 pesticidal
pharmaceutical and other chemicals to wild birds. Toxicology
and Appljed Pharmacology 21(? ):315—330. (Also in unpublished
submission received Apr 25, 1978 under 476-2180; submitted by
Stauffer Chemical Co., Richmond, Calif.; CDL:233577-C)
00022923 Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary
Toxicities of Environmental Pollutants to Birds: Special Scien-
tific Report——Wildlife No. 191. (U.S. Dept. of the Interior,
Fish and Wildlife Service, Patuxent Wildlife Research Center;
unpublished report)
00025123 Chevron Chemical Company (1979) Determination of Captafol, Captan,
THPI, and 3—OH THPI in Tissues and Eggs and Determination of
Captan, THPI, 3—OH THPI, and 5—OH THPI in Milk and Cream. Un-
dated method nos. RM-6—G—2, RM-1G—1 and RRC—75-32. (Unpublished
study received Jan 2, 1980 under 239-2211; prepared in coopera-
tion with Stauffer Chemical Co.; CDL:099190—F)
00025125 Leary, J.B.; Lai, J.C. (1976) Captan——Lactating Dairy Cow Feeding
Study——Residues in Meat. (Unpublished Study received Jan 2,
1980 under 239—2211; submitted by Chevron Chemical Co., Rich-
mond, Calif.; CDL:099190—H)
143
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Captan Standard
MRID CITATION
00025129 Cheng, H.M. (1976) Metabolism of Carbonyl—14C-difolatan in Young
Tomato and Corn Plants. (Unpublished study received Jan 2, 1980
under 239—2211; submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:099190—L)
00034713 Tooby, T.E.; Hursey, P.A.; Alabaster, J.S. (1975) The acute toxic-
ity of 102 pesticides and miscellaneous substances to fish.
Chemistry and Industry 21(?/Jun):523—526. (Published study)
00035246 Haumschild, 0.; Wingender, R.J. (1972) Report to American Seed
Trade Association, Inc.: Tissue Residue Study for Captan and
Tetrahydrophthalimide in Crossbred Steers Fed Technical Captan:
IBT No. J1255. Includes methods entitled: Determination of Cap—
tan and Determination of Tetrahydrophthaljmjde (THPI). (Unpub-
lished Study received Jun 27, 1977 under 3E1367; prepared by In-
dustrial Bio—Test Laboratories, Inc., submitted by Stauffer
Chemical Co., Richmond, Calif.; CDL:096174—A)
00035248 Taylor, R.E.; Brunhouse, E. (1972) Captan Study for American Seed
Trade Association. Includes method RM—1E dated May 25, 1972.
(Unpublished Study including letter dated Feb 1, 1973 from J.C.
Calandra to Ron Harris, received Jun 27, 1977 under 3E1367; pre-
pared by Harris Laboratories, Inc., submitted by Stauffer Chemi-
cal Co., Richmond, Calif.; CDL:096174—D)
00042645 Rappaport, S.H.; Katague, D.B. (1978) Determination of Captan Resi-
dues in Crops by Gas Chromatography. Method RRC—76—30R dated
Mar 27, 1978. (Unpublished Study received Sep 25, 1980 under
0E2427; prepared by Stauffer Chemical Co., submitted by New Zea-
land, Ministry of Agriculture and Fisheries, Wellington, New
Zealand; CDL:099651-C)
00042646 New Zealand, Ministry of Agriculture and Fisheries (19??) Method
for the Determination of Captan Residues in Kiwifruit. (Unpub-
lished Study; CDL:099651—D)
00044657 Ja, B.Y.; Smith, W.J.; Barney, J.E. (1971) Assay of Technical
Captain and Its Formulations by Gas Chromatography. Stauffer
Analytical Method no. 16 dated Mar 1971. (Unpublished study
received Mar 29, 1971 under 476—2100; Submitted by Stauffer
Chemical Co., Richmond, Calif.; CDL:101422—A)
144
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Captan Standard
MRID CITATION
00045174 Haumschild, 0.; Wingender, R.J. (1972) Report to American Seed
Trade Association, Inc.: Tissue Residue Study for Captan and
Tetrahydrophthalimjde in Crossbred Steers Fed Technical Captan:
IBT No. J1255. Includes undated methods entitled: Determination
of Captan and Determination of Tetrahydrophthalimjde (THPI).
(Unpublished Study received Mar 9, 1973 under 3E1367; prepared
by Industrial Bio—Test Laboratories, Inc., submitted by American
Seed Trade Association, Inc., Kalamazoo, Mich.; CDL:096506-C)
00045175 American Seed Trade Association, Incorporated (19??) Analytical
1ethod Used for Residue Analysis of Captan. (Unpublished study
received Mar 9, 1967 under 3E1367; CDL:096507-B)
00045176 Wilson, M. (1973) Captan Residue Report: Field Corn Seed. (Unpub..
lished study received on unknown date under 3E1367; submitted by
American Seed Trade Association, Inc., Kalamazoo, Mich.; CDL:
096507—C)
00045178 American Seed Trade Association, Incorporated (1973) Supplement to
American Seed Trade Association, Inc. Petition # 3F1367 for a
Captan Tolerance on Detreated Corn Seed Intended as Feed for
Beef Cattle and Swine. (Unpublished Study including letter
dated Apr 25, 1973 from J.C. McKay to Harold Wright, received on
unknown date under 3E1367; CDL:096507—E)
00045179 Patchett, G.G. (1973) Determination of Tetrahydrophthalamic acid
Residues in Cattle and Hog Tissues. Method no. WRC 73—38 dated
May 17, 1973. (Unpublished study received on unknown date under
3E1367; prepared by Stauffer Chemical Co., submitted by American
Seed Trade Association, Inc., Kalamazoo, Mich.; CDL:096507—F)
00045182 American Seed Trade Association, Incorporated (19??) Determination
of Captan Residues on Treated Seed Corn. Undated method. (Un-
published study received Mar 9, 1967 under 3E1367; CDL:096507—J)
00045183 American Seed Trade Association, Incorporated (19??) Method for De-
termination of Captan Residue on Corn. (Unpublished Study re-
ceived Mar 9, 1967 under 3E1367; CDL:096507-K)
00045184 Kilgore, W.W.; Winterlin, W.; White, R. (1967) Gas chromatographic
determination of Captan residues. Journal of Agricultural and
Food Chemistry 15(6):1035—1037. (Also in unpublished submission
received on unknown date under 3E1367; submitted by American
Seed Trade Association, Inc., Kalamazoo, Mich.; CDL:096507—L.)
145
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Captan Standard
MRID CITATION
00045188 Chevron Chemical Company (1972) Determination of Captari Residues in
Animal Tissues. Method RM—1E dated May 26, 1972. (Unpublished
study received on unknown date under 3E1367; submitted by Amen—
can Seed Trade Association, Inc., Kalamazoo, Mich.; CDL:
096507—Q)
00045189 Wingender, R.J. (1973) Report to American Se d Trade Association,
Inc.: Results from the Analysis of Hog issues for Tetrahydro—
phthalimide: IBT No. D2043. (Unpublisned Study received Mar 9,
1973 under 3E1367; prepared by Industrial Blo—Test Laboratories,
Inc., submitted by American Seed Trade Association, Inc., Kala-
mazoo, Mich.; CDL:096506—F)
00046914 Hensill, G.S. (1957) Phaltari Res earch Report 1957. (Unpublished
study received Oct 28, 1957 under unknown admin. no.; submitted
by Chevron Chemical Co., Richmond, Calif.; CDL:119324—A)
00053324 California Spray—Chemical Corporation (1957) Methods of Residue
Analysis of Captan or Phaltan. (Unpublished study received Feb
11, 1958 under unknown admin. no.; submitted by Chevron Chemical
Co., Richmond, Calif.; CDL:119325—A)
00054015 California Spray Chemical Corporation (1960) The Analysis of Resi-
dues of Captan and Phaltan. Method RM—1 dated Apr 4, 1960.
(Unpublished study received Jul 14, 1972 under 2E1215; submitted
by Interregional Research Project No. 4, New Brunswick, N.J.;
CDL: 09 104 3-A)
00054016 University of Hawaii (1969) Captan—Taro Residue Study. (Unpub-
lished study received Jul 14, 1972 under 2E1215; prepared by
Agricultural Biochemistry Dept., Pesticide Laboratory in coop-
eration with Chevron Chemical Co., submitted by Interregional
Research Project No. 4, Ne w Brunswick, N.J.; CDL:091043-B)
00054789 Nelson, N. (1949) A Preliminary Toxicological Study of SR-406, a
Fungicide. (Unpublished study received Jun 1, 1965 under un-
known admin. no.; prepared by New York Univ., Bellevue Medical
Center, Laboratory of Industrial Toxicology, submitted by Chev- .
ron Chemical Co., Richmond, Calif.; CDL:001148—A)
00054791 New York University (1951) Progress Report No. 2: Continuation
Studies on SR-406. (Unpublished study received Jun 1, 1965
under unknown admin. no.; prepared by Bellevue Medical Center,
Laboratory of Industrial Toxicology, submitted by Chevron Chemi-
cal Co., Richmond, Calif.; CDL:001148—C)
146
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Captan Standard
MRID CITATION
00057846 Hermanutz, R.O.; Mueller, L.H.; Kempfert, K.D. (1973) Captan toxic-
ity to fathead minnows (Pimephales promelas), bluegills
(Lepomis macrochirus), and brook trout (Salvelinus forn—
tinalis). Journal of the Fisheries Research Board of Canada
30(12):1811—1817. (Also in unpublished submission received Jan
21, 1977 under 239-533; submitted by Chevron Chemical Co., Rich-
mond, Calif.; CDL:230401—C)
00058608 Mitchell, A.D.; Robinson, D.E.; Beck, J.C. (1980) An Evaluation of
the Effect of Captan on Unscheduled DNA Synthesis in Diploid
Human Fibroblasts: Contract Nos. 68-01—2458 and 68-02—2947; SRI
Projects LSU—3493 and LSU—7558. Final rept. (SRI International
for U.S. Environmental Protection Agency; unpublished study;
CDL :244432—A)
00058940 Cheng, H.M. (1980) Metabolism of Carbonyl—14C-Captan in a Lac-
tating Goat: .File No. 721.14/Captan. (Unpublished study re-
ceived Oct O, 1980 under- 239—533; submitted by Chevron Chemical
Co., Richmond, Calif.; CDL:243629—B)
00058941 Cheng, H.M. (1980) Degradation Products of Carbonyl—14C-Captan
in Apple and Orange Processed Parts: File No. 721.14/Captan.
(Unpublished Study received Oct 30, 1980 under 239-533; sub-
mitted by Chevron Chemical Co., Richmond, Calif.; CDL:243629—D)
00068076 Wong, Z.A.; Bradfield, L.G.; Akins, B.J.; et al. (1981) Socal 1150:
Lifetime Oncogenic Feeding Study of Captan Technical (SX-944) in
CD—i Mice (ICR Derived). (Unpublished Study received Jan 29,
1981 under 239—533; submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:244220—A; 244221; 244222; 244223; 244224; 244225;
244226)
00070201 California Spray Chemical Corporation (1957) Captan Residues——
Various Crops. (Reports by various sources; unpublished study
received Feb 25, 1957 under PP0124; CDL:090426-J)
00070414 Pack, D.E. (1974) The Soil Metabolism of Carbonyl-14C-Captan:
File No. 773.21. (Unpublished study received Nov 26, 1974
under 239—533; submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:120648—B)
00070751 Boudr’eau, P.; Forbis, A.D.; Cranor, W.; et al. (1980) Static Acute
Toxicity of Captan Technical (SX—1086) to Daphnia magna: ABC
Report # 26633. (Unpublished study received Jan 12, 1981 under
239—1246; prepared by Analytical Bio Chemistry Laboratories,
Inc., submitted by Chevron Chemical Co., Richmond, Calif.; CDL:
244428—A)
147
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Captan Standard
MRID CITATION
00071790 Stauffer Chemical Company (1980) Residue Data of Various Chemi-
cals, Including Captan, on Soybeans. (Compilation; unpub-
lished study received Dec 12, 1980 under AR 80/24; submitted by
state of Arkansas for Stauffer; CDL:243877-A)
00078623 Chevron Chemical Company (1979) Teratology Study in Hamsters:
IRDC No. 415—005. (Compilation; unpublished study, including
IRDC no. 999—015, received Jun 20, 1979 under 239—1246; CDL:
238658—C)
00080871 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1972) Effect of
Pesticides on Apiculture: Project No. 1499. 1972 annual rept.
(Unpublished study received Jan 24, 1974 under 4F1459; prepared
by Univ. of California——Riverside, Dept. of Entomology, Div. of
Economic Entomology, submitted by Nor-Am Agricultural Products,
Inc., Naperville, Ill.; CDL:093885—A)
00083100 Pack, D.E. (1980) Analysis of Soybeans Grown from Seed Treated with
14C—Captan——GreenhouSe Study: File 721.14. (Unpublished study
received Mar 23, 1981 under 239—2457; submitted by Chevron Chem-
ical Co., Richmond, Calif.; CDL:244766—A)
00083393 California Chemical Company (1961) The Determination of and Differ-
entiation between Residues of Phaltan and Captan: File 740.10.
Residue method RM—1A dated Jan 31, 1961. (Unpublished study
received on unknown date under PP0283; CDL:090305-D)
00085524 California Spray—Chemical Company (1955) Spray Residue Remaining
from the Use of Captan as an Agricultural Fungicide. (Compila-
tion; unpublished study received May 1, 1955 under PPOO15; CDL:
090983-N) -
00085525 Petrino, L.M. (1955) Colorirnetric Estimation of Captan Surface Res-
idue on Fruit Samples: (Adaptation of Method Published in Ana-
lytical Chemistry, July, 1952, Page 1173). Method dated Mar 21,
1955. (Unpublished study received May 1, 1955 under PPOOI5;
prepared by Stauffer Chemical Co., submitted by California
Spray—Chemical Co., Richmond, Calif.; CDL:090983—O)
00085526 California Spray—Chemical Company (1954) Determination of Captan
Residues. (Unpublished study received May 1, 1955 under PPOO15;
CDL :090983—P)
00086288 Gregory, L.K.; Narcisse, J.K. (1974) The Acute Inhalation Toxicity
of Orthocide 83: SOCAL 589/XIII:129 (5-647). (Unpublished
study received Sep 24, 1975 under 239—729; submitted by Chevron
Chemical Co., Richmond, Calif.; CDL:140140—F)
148
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Captan Standard
MRID CITATION
00086803 Rodwell, D.E. (1979) Teratology Study in Hamsters: 415—005. Amend-
ment to the final rept. (Unpublished Study received Sep 28,
1981 under 239—1246; prepared by International Research and De-
velopment Co”p., submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:246246—A)
00087805 Brusick, D.J.; Nguyen, 1.0.; McGowan, J. (1981) Mutagenicity Eval-
uation of Captan in the Somatic Cell Mutation Assay: LBI Project
No. 20951. Final rept., rev. Includes method dated Apr 10,
1978. (Unpublished Study received Sep 28, 1981 under 239—1246;
prepared by Litton Bionetics, Inc., submitted by Chevron Chemi-
cal Co., Richmond, Calif.; CDL:246244—A; 246245)
00090988 California Spray—Chemical Corporation (1957) The Results of Tests
on the Amount of Residue Remaining, Including a Description of
the Analytical Method Used: Captan. (Compilation; unpublished
study received on unknown date under PP0124; CDL:O90432—D)
00090989 Curtis & Tomkins, Limited (1955) Letter sent to L.W. Hazleton dated
Mar 30, 1955: Determination of captan and tetrahydrophthalimide
residues on apples, concerning lab, no. 55d40. (Incomplete; un-
published study received Apr 18, 1957 under PP0124; submitted by
California Spray—Chemical Corp., Richmond, Calif.; CDL:090432-E)
00093883 Palmer, A.K.; Barton, S.d.; Clark, R. (1981) Effect of Technical
Captan on Pregnancy of the New Zealand White Rabbit: CHR/15/
8114. (Unpublished study received Jan 22., 1982 under 239—1246;
prepared by Huntingdon Research Centre, England, submitted by
Chevron Chemical Co., Richmond, Calif.; CDL:246624-A)
00096901 Crossley, J. (1970) The Fate of Difolatan in a Lactating Ruminant
(Goat): File No. 721.14. (Unpublished study received Jun 9,
1977 under 239—2211; submitted by Chevron Chemical Co., Rich-
mond, Calif.; CDL:096157-C)
00096908 Cheng, H.M. (1979) Metabolism of Carbonyl 14C Captafo] in a Lac-
tating Goat: File No. 721.14. (Unpublished study received Jan
2, 1980 under 239—2211; submitted by Chevron Chemical Co., Rich-
mond, Calif.; CDL:099191-G)
00096910 Hillebrecht, W.R.; Riggs, R.L. (1977) Captan Milk Residue Study
in Lactating Dairy Cattle. (Unpublished study received Jan 2,
1980 under 239—2211; prepared by Stauffer Chemical Co., sub-
mitted by Chevron Chemical Co., Richmond, Calif.; CDL:099191—I)
149
-------
OFFICE OF PESTICIDE PI RAMS
REX3ISTRATION STANDARD BIBLIOGRApF-Iy
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Captan Standard
MRID CITATION
00096972 Pack, D.E. (1977) Soil Mobility of Captan, Folpet and Captafol As
Determined by Soil Thin—layer Chromatography: File . 722.0.
(Unpublished study received May 30, 1978 under 239—2211; sub-
mitted by Chevron Chemical Co., Richmond, Calif.; CDL:234046—N)
00096974 Wolfe, N.L.; Zepp, R.G.; I ster, J.C.; et al. (1976) Captan hydrol-
ysis. Journal of Agricultural and Food Chemistry 2 (5):’.;41—
1045. (Also in unpublished sul ission received May iD, 1978
under 239—2211; submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:234046—R)
00096978 Abell, 3.; Moore, J.E. (1967) Attempts To Den nstrate the Trans—
location of Difolatan and Orthocide: File t b. 721.13. (Unpub-
lished study received May 30, 1978 under 239—2211; subiutted by
Chevron Chemical Co., Richmond, Calif.; CDL:234O46—p B)
00096982 Chevron Chemical Company (1979) Residue Data Sheet: Soybeans:
Test Nb. T—4546. (Compilation; unpublished study received
Mar 28, 1979 under 239—2369; CDL:237912—A)
00097622 Stauffer Chemical Company (1976) Captan 80—WP on Soybeans: Summary
of Crop Residue Data. (Compilation; unpublished study received
1976 under 476— —77; CDL:228997—A)
00098295 Chevron Chemical Company (1980) One Generation Reproduction Stud-
ies with Captan (SX—1086). (Compilation; unpublished study
received Apr 5, 1982 under 239—1246; CDL:247147—C)
00098296 Chevron Chemical Company (1980) Captan (SX—1086)/Orie Generation
Reproduction Studies, Including Diet Analyses. Includes method
dated Jun 15, 1979. (Compilation; unpublished study received
Apr 5, 1982 under 239—1246; CDL:247147—D)
00098708 Chevron Chemical Company (1950) Residue Studies of Orthocide 406
on Tbmatoes. (Compilation; unpublished study received Mar 21,
1951 under 239—533; CDL:001157—B)
00098709 Chevron Chemical Company (1950) Residue Studies of Orthocide 406
on Various Vegetables. (Compilation; unpublished study re-
ceived Mar 21, 1951 under 239—533; CDL:001157—C)
00098710 Davis, D.L. (1950) Residue Analysis——SR—406: Snap Beans. (Un—
published study received Mar 21, 1951 under 239—533; submitted
by Chevron Chemical Co., Richn nd, Calif.; CDL:001157—D)
150
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Captan Standard
MRID CITATION
00098711 Davis, D.L. (1950) Residue Analysis——SR—406: Apples. (Unpub—
lished study received Mar 21, 1951 under 239—533; submitted by
Chevron Chemical Co., Richmond, Calif.; CDL:001157—E)
00098716 Kahn; G.K. (1954) Captan Residues on Potatoes. (Unpublished study
received Jun 2, 1954 under 239—533; submitted by Chevron Chem-
ical Co., Richmond, Calif.; CDL:001163-A)
00098719 Zoebisch, O.C. (1954) Letter sent to G.S. Hensill dated Aug 18,
1954 Orthocide 50 in pineapple tissue. (Unpublished study
received Sep 13, 1954 under 239-533; prepared by Libby McNeill
& Libby, submitted by Chevron Chemical Co., Richmond, Calif.;
CDL : 001169—A)
00098720 Chevron Chemical Company (1952) Analysis of Fruits and Vegetables
for Captan Residues. (Unpublished study received Mar 22, 1955
under 239—533; CDL:001177—A)
00098722 Kahn, G.K. (1958) Letter sen’t to G.S. Hensill dated May 21, 1958:
Captan residues: postharvest t”eatment. (Unpublished study
received Jun 20, 1958 under 239-533; submitted by Chevron Chem-
ical Co., Richmond, Calif.; CDL:0O1194—A)
00098726 Chevron Chemical Company (1950) SR-406: Residues in Various
Crops. (Compilation; unpublished study received Oct 10, 1951
under 239—1102; CDL:001257—B)
00098731 Kittleson, A.R. (1952) Colorimetric determination Of N—trichloro—
methiotetrahydrophthalimide. Analytical Chemistry 24:1173—1174.
(Also in unpublished submission received Feb 21, 1973 under
1486—20; submitted by Ferro Corp., Bedford, Ohio; CDL:006427-C)
00098741 Makhteshim Beer-Sheva Chemical Works, Limited (1972) Chemical Data
on Merpan. (Compilation; unpublished study, including
DS.13.51.31, DS.13.51.2 and DS.13.51.13, received Jun 2, 1972
under 11678—2; CDL:02318].-A)
00098746 Makhteshim Beer-Sheva Chemical Works, Limited (1972) Studies of
the Chemical Merpan. (Compilation; unpublished study, includ—
ing OS 13.51, 13.51.2, 13.51.10, received Apr 17, 1972 under
11678-1; CDL:026318—A)
00098747 Makhteshim Chemical Works Limited (1969) Merpan: Residue Analysis:
OS 13.51.11. (Unpublished study received Apr 17, 1972 under
11678—1; CDL:026318-B)
1 51
-------
OFFICE OF PESTIICDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Captan Standard
MRID CITATION
00098751 Chevron Chemical Company (1954) Captan Residues in Meat. (Unpub-
lished Study received May 5, 1954 under 239—656; CDL:027009-B)
00098759 Office of the Commissioner (1961) Residues of Captan in Citrus
and Other Crops. (Compilation; unpublished study received
Oct 2, 1967 under 9E0755; CDL:09].304-F)
00098784 Interregional Research Project Number 4 (1976) Determinarion of
Captan Pesticide in or on Taro Leaves. (Compilation; unpub-
lished Study received Jul 11, 1977 under- 7E1982; CDL:097592—A)
00098786 Mitoma, C. (1972) Pilot Study to Determine the Nature and Magnitude
of the Residues from Ingestion of Captan in a Ruminating Animal
SRI Project LSC—1697. (Unpublished Study received Mar 7, 1977
under 239—2457; prepared by Stanford Research Institute, sub-
mitted by Chevron Chemical Co., Richmond, Calif. CDL:096129—B)
00098787 Hoffman, L.J.; DeBaun, J.R.; Knarr, J.; et a]. (1976) Metabolism of
N —(trichlorornethylthio)_1,2_d lcarboxim ldo_14C_4_cyc]ohex_
ene (Captan) in the Rat and Goat: ARC—B—33. Rev. (Unpublished
study received Mar 7, 1977 under 239—2457; prepared by Stauffer
Chemical Co., submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:096129-C)
00098789 Chevron Chemical Company (1976) Captan Residue Analyses--Apples.
(Compilation; unpublished study, including test nos. 1—3513 and
1—3514, received Mar 7, 1977 under 239—2457; CDL:096129—H)
00098790 DeBaun, J.R.; Gruwell , L.A.; Menn, J.J. (1975) The Fate of Captan
Carbonyl—14C on Field—grown Apple Trees: MRC-B-44. Rev.
(Unpublished study received Mar 7, 1977 under 239—2457; prepared
by Stauffer Chemical Co., submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:096129—I)
00098798 Barney, J.E. (1970) Assay of Technical Captan, Captan Dusts, and
Wettable Powders: Stauffer Analytical Method No. 2. (Unpub-
lished Study received Mar 29, 1971 under 476-2100; submitted by
Stauffer Chemical Co., Richmond, Calif.; CDL:101419—A)
00098804 California Spray—Chemical Corporation (1961) Residue Data Sheet:
Almonds: Test No. 1—239. (Unpublished study received Jan
24, 1962 under 239—533; submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:121209—A)
00098808 Chevron Chemical Company (1957) Captan: Residues in Cattle.
(Compilation; unpublished study, including cattle progress re-
port 247, received May 9, 1961 under unknown admin. no.; CDL
121212—C)
152
-------
OFFICE OF PESTIICDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Captan Standard
MRID CITATION
00098810 Cripps, J.M. (1957) Letter sent to California Spray—Chemical Cor-
poration dated Feb 13, 1957: Captan residues——chicken eggs,
breasts, thighs and livers. (Unpublished study received May 9,
1961 under unknown admin. no.; submitted by Chevron Chemical
Co., Richmond, Calif.; CDL:121212—G)
00098811 Chevron Chemical Company (1957) Captan Residues in Almonds.
(Compilation; unpublished study received May 9, 1961 under un-
known adrnin. no.; CDL:121212—H)
00098817 Chevron Chemical Company (1957) Residue Studies of Captan on
Raisins. (Compilation; unpublished study received Jun 25, 1957
under 239—104; CDL:121282—A)
00098818 Pennwalt Corporation (19??) Captan Residue on Cantaloupes Treated
with Decco Salt No. 10. (Unpublished Study received Aug 5,
1957 under unknown admin. no.; CDL:121594—A)
00098831 Tagawa, H.; Yamaguchi , Y. (1970) Persistence of Captan and Difo—
latan in Soil and Their Absorption by Tobacco Plants from Soil.
A translation of: Without Title. Bulletin of the Hatano
Tobacco Experiment Station, Yokohama, Kangagwa, Japan73:353..
(Unpublished study received Jan 4, 1978 under 239—1246; sub-
mitted by Chevron Chemical Co., Richmond, Calif.; CDL:232569-H)
00098845 Makhteshim Beer-Sheva Chemical Works, Limited (1973) Chemistry of
Merpan Technical. (Compilation; unpublished study received
Dec 15, 1976 under 11678—1; CDL:227308-A)
00098862 Chevron Chemical Company (1978) Composition of Captan Technical
Including HPLC Methods of Analysis. (Compilation; unpublished
study, including file nos. 721.2 and 750.15, received Oct 30,
1978 under 239-1246; CDL:235665—A)
00098881 Pack, D.E. (1979) The Anaerobic Soil Metabolism of Carbonyl—
14C captan: File No. 721.14. (Unpublished study received Aug
27, 1979 under 239—2457; submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:240891—B)
00098893 Chevron Chemical Company (1978) Product Chemistry Data-—Captan.
(Compilation; unpublished study, including file no. 721.2, re-
ceived Sep 18, 1979 under 239-2474; CDL:241046-A)
00098894 Chevron Chemical Company (1979) Analyses for Orthocide Plus in
Potatoes. (Compilation; unpublished Study received Sep 18,
1979 under 239—2474; CDL:241047—A)
153
-------
OFFICE OF PESTIICDE PRCKRAMS
R 3ISTRATION STANDARD St BLI(XRAPHY
Citations Considered to be Part of the Data Base Supportir
Registrations Under the Captan Standard
MRID cITATIoN
00104083 Stromberg, K. (1975) Sub-lethal Effects of Seed Treatment Pesti-
cides on Breeding Hen Pheasants. DDctoral Dissertation, Michi-
gan State Univ., Dept. of Fisheries and Wildlife. (Unpublished
study received Mar 5, 1979 under 239—579; submitted by Chevron
Chemical Co., Richncnd, CA; CDL:237966—A)
00104753 McKay, J.C. (1973) Letter sent to Harold Wright dated Mar 2, 1973
Determinations for residues of tetrahydrophthalamic acid——
Captan. (Unpublished study received Mar 9, 1973 under 3E1367;
prepared by Stauffer Chemical Co., submitted by American Seed
Trade Association, Inc., Kalamazoo, Mich.; CDL:096506—D)
00106602 Stauffer Chemical Company (1975) Sumnary of Crop Residue Data Sup-
porting Registration of Captan: Irnidan 16:12—WP. (Compilation;
unpublished study received Mar 21, 1975 under 476—2172; CDL:
0284 53—D)
00114210 Siirvron, ‘I.; Mitchell, A.; Jorgenson, T. (1977) Evaluation oE
Selected Pesticides as Chemical Mutagens in vitro and in vivo
Studies: EPA—600/1--77—028; Contract r\k. 68—01—2458; Olin 3554.
(Stanford Research Institute for U.S. Environmental Protection
Agency, Office of Research and Development, Health Effects Re-
search Laboratory; unpublished study; CDL:248284-E)
00117083 Adir, J.; Chin, T.: Ruch, G.; et al. (1982) Captart 50—WP: A Dermal
Absorption Study in Rats: T—11008. (Unpublished study received
Sep 3, 1982 under 476—2099; submitted by Stauffer Chemical Co.,
Richiiond, CA; CDL:248429—A)
00117087 Maddy, K.; Kahn, C.; Riddle, L.; et al. (1977) A Breakd n Study of
Captari ... on Strawberry Foliage and Fruit in Ventura County,
California ACF 59—372. (California, Dept. of Food and Agricul-
ture, Agricultural Chemicals and Feed; unpublished study; CDL:
2484 29—E)
00117088 Maddy, K.; Edmiston, S.; Kahn, C.; et al. (1977) A Study of the De-
cay of Captan on the Foliage and Fruit of Strawberries in Santa
Cruz County, California: ACF 59—376. (California, Dept. of Food
and Agriculture, Agricultural Chemicals and Feed; unpublished
00120315 Schardein, J.; Aldridge, D. (1982) One Generation Reproduction
Study in Rats with Captari: 153—190; T—10486. (Unpublished
study received Nov 18, 1982 under 476—2099; prepared by Inter-
national Research and Development Corp., submitted by Stauffer
Chemical Co., Richnond, CA; CDL:249019—A)
study; CDL:248429—F)
154
-------
OFFICE OF PESTIICDE PRCXRAMS
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Captan Standard
N1RID CITATION
00120316 Goldenthal, E.; Warner, M.; Rajasekaran, D.; et al. (1982) 2—year
Oral Toxicity/Carciriogenicity Study of Captan in Rats: 153—097.
(Unpublished study received Nbv 18, 1982 under 476—2099; pre-
pared by International Research and Development Corp., subnitted
by Stauffer Chemical Co., Richrrond, CA; CDL:249020—A; 249021;
249022; 249023; 249731)
00125293 Schardein, 3.; Schwartz, C.; Thorstenson, J. (1982) Three Genera-
tion Reproduction Study in Rats: 153—096. (Unpublished study
received Jan 20, 1983 under 239—1246; prepared by International
Research and Development Corp., submit.ted by Chevron Chemical
Co., Richrrcrid, CA; CDL:249334-A)
00126348 Schardein, J. (1983) Teratology Study in Hamsters: 415—005. Amend-
ed final rept. (Unpublished study received Mar 9, 1983 under
Corp., submitted by Chevron Chemical Co., Richrrond, CA; CDL:
249681—A)
00126845 Daly, I.; Knezevich, A. (1983) A Lifetime Oral Oncogenicit.y Study
of Captan in Mice: Project Nb. 80—2491. Final rept. (Unpub-
lished study received Apr 14, 1983 under 239—1246; prepared by
Bio/dynamics, Inc., sut nitted by Chevron Chemical Co., Richrtond,
CA; CDL:249943—A; 249942; 249948: 249944; 249945; 249946;
249947)
00128355 Chevron Chemical Co. (1982) Residue Chemistry Data: Captan.
(Compilation; unpublished study received May 19, 1983 under
3F2898; CDL:071624—A; 071625; 071626)
00128621 Bullock, C. (1982) The Eye Irritation Potential of Chevron Captan
90 Concentrate: Socal 1919 (S—2086). (Unpublished study re-
ceived May 25, 1983 under 239—2137; submitted by Chevron Chemi-
cal Co., Richnond, CA; CDL:250381—A)
00129157 Saunders, D. (1983) Letter sent to t4. Sauerhoff dated Jun 9, 1983:
Historical data: T—10002. (Unpublished study received Jun 15,
1983 under 476—2099; submitted by Stauffer Chemical Co., Rich—
n nd, CA; CDL:250668—A)
00129163 Stauffer Chemical Co. (1982) Revised Pages of 2—year Oral Toxici—
ty/Carcinogenicity Study of Captari in Rats with Captan Techni-
cal, SX944: 153—097. (Unpublished study received Jun 15, 1983
under 476—2099; CDL:250667—A)
00131715 Ficsor, G.; Bordas, S.; Wade, S.; et al. (1977) Mammilian host— and
fluid—mediated mutagenicity assays of captan and streptozotociri
in salnonella typhirnuriuin. Mutation Research 48:1—15. (Also in
unpublished subnission received Nbv 28, 1980 under unkn n ad—
mm. no.; submitted by Stauffer Chemical Co., Richnorid, CA; CDL:
251563—E)
155
-------
OFFICE OF PESTIICDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Captan Standard
MRID CITATION
00131725 Tezuka, H.; Teramoto, S.; Kaneda, M.; et al. (1978) Cytogenetic and
dominant lethal studies on captan. Mutation Research 57:201-
207. (Also in unpublished submission received Nov 28, 1980 un-
der unknown admin. no.; submitted by Stauffer Chemical Co.,
Richmond, CA; CDL:251563—S)
00131727 Tezuka, H.; Ando, N.; Suzuki, R.; et al. (1980) Sister-chromatid
exchanges and chrornosomal aberrations in cultured chinese hams-
ter cells treated with pesticides positive in microbial rever-
sion assays. Mutation Research 78:177—191. (Also in unpub-
lished submission received Nov 28, 1980 under unknown admin.
no.; submitted by Stauffer Chemical Co., Richmond, CA; CDL:
25156 3—U)
00151236 Beavers, J. (1978) Acute Oral LD5O — Bobwhite Quail: Orthocide
Technical: Final Report: Project No. 162—102. Unpublished study
prepared by Wildlife International, Inc. 15 p.
05001991 Stevenson, J.H. (1978) The.acute toxicity of unformulated
pesticides to worker honey bees (Apis mellifera). Plant
Pathology 27(1):38-40.
GSO12O—OO1 Lukens, R; Sisler, H. (1958) Chemical reactions involved in
the fungitoxicity of captan. Phytopathology 48:235:244.
Published study.
GSO12O—003 DeBaun, J.; Miaullis, J.; Knarr, J. al. (1973) The metabolic
fate of captan (trichloromethylthio-14C) in the rat. Report
No. ARC—B-34. Submitted by Stauffer Chemical Co.
GSO12O—004 Hoffman, L.; Debaun, J.; Knarr, J.; Menn, J. (1973) Metabolism
of N—(trichloromethylthio)—1,2—dicarboximide 14C-4-cyclohexene
(Captan) in the rat. Report No. ARC—B—36. Submitted by
Stauffer Chemical Co.
GSO12O—008 Chevron Chemical Co. (1978) Determination of captan residues in
crops: RM—1F-2. Unpublished method dated June 5, 1978.
GSO12O—011 Pomerantz, I. (1968) Residue method for captan, folpet, and
difolatan. Memorandum sent to Petitions Review Branch
September 9, 1968.
GSO12O—039 American Seed Trade Association (1973) Captan: Methods for
removing residues from corn seed that exceed any proposed
tolerance. Unpublished study submitted by American Seed
Trade Assocation under Petition 3E1367.
156
-------
OFFICE OF PESTIICDE P X RN ’1S
REXISTPATION STANDARD BIBLI(XRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Captan Standard
MRID CITATION
GSO12O—041 U.S. EPA (1979) 48—hr EC5O study of technical captan to Daphriia
magna. Laboratory of Terrestrial and uatic Biology,
Chemical and Biological Investigations Branch, Beltsville, MD
GSO12O—042 U.S. EPA (1979) 96—hr LC5O study of technical captan to bluegill.
Laboratory of Terrestrial and quatic Biology, Chemical and
Biological Investigations Branch, Beltsville, MD.
GSOI2O—047 Wildlife International (1978) Acute Oral L C5O — Bobwhite Quail
Orthocide Technical-Final Report. Submitted by Chevron
Chemical Co.
GS9999—OO1 Hudson, R.; Tucker, R.; Heagele, M. (1984) Handbook of Toxicity
of Pesticides to Wildlife. U.S.D.I. Publication 153,
Washington, D.C. -
GS0144—012 Johnson, W.; Finley, M. (1980) Handbook of acute toxicity of
chemicals to fish and aquatic invertebrates. U.S. Fish and
Wildlife Service Publication b. 137. Washington, D.C.
157
-------
0MB Approval 2070—0057 (expires 5/31/86)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
(To qualify, c tify J j four Items) 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 wnting to enter into such en 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 otter was made
to the following firm(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)(8). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME SiGNATURE DATE
I
EPA Form 8580-6 (10-82)
-------
L _ j ...j ,, , .
(E.. r ires I31/Sf-
EPA REGISTRATION NO
FIFRA SECTION 3(C)(2)(B) SUMMARY SHEET
PRODUCT NAME
APPLICANT’S NAME DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit “generic” data imposed by the FIFRA section 3(C)(2)(B) notice contained in the referenced
Guidance Document. I am responding in the following manner
0 1 I will submit data in a timely manner to satisfy the following requirements. If the test procedures I will use deviate from (or are not
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group, OECD
Chemicals Testing Programme, I enclose the protocols that I will use
02. I have entered into an agreement with one or more other registrants under FIFRA section 3(C)(2)(B)(ii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by
NAME OF OTHER REGISTRANT
0 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.
04. I request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
o 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 8580-1 (10-82)
-------
Appendix 111-1
PRODUCT SPECIFIC DATA REPORT
EPA R istratjon No. Guidance I)Dcunent for________
E te
I
R istratjon
Guideline No. Name of Test
Testnot
required
for my
product
listed
above
(check
below)
I am c np1ying with
data requ1r nents by
J
(Fbr EPA Use Only)
Accession Numbers
Assigned
Citing MRI
&thmit-
ting
t ta
(At—
tached)
§158.20
PRODUCT
CHEMISTRY
61—1
Identity of
ingredients
61—2
Stateiient of
composition
61—3
Discussion of’
formation of
ingredients
62-1
Preliminary
analysis
62-2
Certification of
limits
62-3
Analytical methods
for enforcenent
limits
63—2
Color
63—3
PhysIcal state
63—14
Odor
63—5
Melting point
63—6
Boiling point
63—7
E nsity, bulk—
density, or
specific gravity
.
63—s
Solub l .ty
63-9
Vapor pressure
63—10
Dissociation
constant
63—11
Oetano1/ ter
partition
coefficient
63—12
pH
160
-------
Appendix 111-1 (continued)
R istration
Guideline No.
Name of Test
Test not
required
for my
product
listed
above
(check
below)
I am ccii plying with
data requirements by
(For EPA Use ly)
Accession Numbers
Citing MFID#
Sut n1t—
ting
E ta
(At—
tached)
63—13
StabIlity
Assigned
63-l’4
Oxidizing/reduci ng
reaction
63—15
F lairniabillty
63—16
Explodabillty
63—17
Storage stability
‘
63—18
Viscosity
63—19
MiscibIlity
-
63—20
Corrosion
characteristics
63—21
DielectrIc break—
down_voltage
••
5158.135
‘IOXICOLOGY
81—1
-
Acute oral LD-50,
rat
81-2
Acute der na1
LD—50
81—3
.
Acute inhalation,
LC—50 rat
81—u
Primary eye
irritation, rabbit
81-5
PrImary dermal
irritation
81—6
E nrial sensitiza-
tion
161
-------
Apendix 111—1
PRODUCT SPECIFIC DATA REPORT
EPA R istrati.on No. Guidance cui ent for________
E .te
R istration
Guideline No.
I
Name of Test
Test not
required
for my
prcduct
listed
above
(check
below)
I am canplying with
data requir nents by
(Fbr EPA Use Only)
Accession Numbers
Assigned
Citing MRID#
Submit-
ting
L .ta
(At-
tached)
§158.20
PRODUCT
CHEMISTRY
-
61—1
Identity of
ingredients
61—2
Stat nent of
canpositlon
61—3
.
DIscussion or
formation of
ingredients
62—1
PrelIminary
analysis
62—2
CertifIcation of
limits
62-3
Analytical methods
for enforcenent
limits
63—2
Color
63—3
Physical state
63—4
Odor
63—5
Melting point
63—6
Boiling point
63—7
Density, bulk—
density, or
specific gravity
•
63-8
So lubil.ity
.
63—9
Vapor pressure
63—10
DissocIation
constant
-
6 3—11
Octanol/ ter
partition
coefficient
63-12
p&i
1.62
-------
Appendix 111-1 (continued)
R istration
Guideline No.
Name of Test
Test not
required
for my
product
listed
above
(check
below)
I am ccmplying with
data requirements by
(P r EPA Use Qily)
Accession Numbers
Assigned
•
Citing MRID#
Submit-
ting
E ta
(At—
tached)
63—13
StabilIty
63—14
Oxidizing/reducing
reaction
63—15
FlanTnability
63—16
Explodabillty
63—17
Storage stability.
63—18
VIscosity
63—19
MIscibility
63—20
CorrosIon
characteristics
•
63—21
Dielectric break-
down voltage
158.135
WXICOLOGY
81—1
Acute oral LD-50,
rat
81—2
Acute dermal
r.LD—50
81—3
Acute inhalation,
I C—50_rat
81—4
PrImary eye
Irritation, rabbit
81—5
PrImary dermal
irritation
81—6
Dennal sensitiza-
tion
163
-------
§162.10 LABELING REQUIREMENTS
(a) General——(1) Contents of the label . Every pesticide
product shall bear a label containing, the information specified by
the Act and the regulations in this Part. The contents of a
label must show clearly and prominently the following:
(i) The name, brand, or trademark under which the product is
sold as prescribed in .paragraph (b) of this section;
(ii) The name and address of the producer, registrant, or
person for whom produced as prescribed In paragraph (c) of this
section;
(iii) The net contents as prescribed in paragraph (d) of this
section;
(iv) The product registration number as prescribed in paragraph
(e) of this section; -
Cv) The producing establishment number as prescribed In para-
graph Cr) of this section;
(vi) An ingredient statement as prescribed in paragraph (g) of
this section;
(vii) Warning or precautionary statements as prescribed in
paragraph (h) of this section;
(viii) The directions for use as prescribed in paragraph (i)
of this section; and
(ix) The use classification(s) as prescribed in paragraph (j)
of this section.
(2) Prominence and legibility . (1) All words, statements,
graphic representations, designs or other information required on
the labeling by the Act or the regulations in this part must be
clearly legible to a person with normal vision, and must be placed
with such conspicuousness (as compared with other words, state-
ments, 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 customary conditions of purchase
and use.
(ii) All required label text must:
(A) Be set in 6—point or larger type;
(B) Appear on a clear contrasting background; and
(C) Not be obscured or crowded.
(3) Language to be used . All required label or labeling text
shall appear in the English language. However, the Agency may
require or the applicant may propose additional text ’in other
languages as is considered necessary to protect the public. When
additional text in another language is necessary, all labeling
requirements will be applied equally to both the English and
other—language versions of the labeling.
(. 14) Placement of Label-—(i) General . The label shall appear
on or be securely attached to the immediate container of the
pesticide product. For purposes of this Section, and the mis—
branding provisions of the Act, “securely attached” shall mean
that a label can reasonably be expected to remain affixed during
164
-------
the foreseeable conditions and period of use. If the immediate
container is enclosed within a wrapper or outside container
through which the label cannot be clearly read, the label must
also be securely attached to such outside wrapper or container,
if it is a part of the package as customarily distributed or
sold.
(i14 ; rik cars and other bulk containers——(A) Transportation .
While a pesticide product is In transit, the appropriate
provisions of 1 19 CFR Parts 170—189, concerning the transportation
of hazardous materials, and specifically those provisions con-
cerning the labeling, marking and placarding of hazardous materials
and the vehicles carrying them, define the basic Federal require-
ments. In addition, when any registered pesticide product Is
transported in a tank car, tank truck or other mobile or portable
bulk container, a copy of the accepted label must be attached to
the shipping papers, and left with the consignee at the time of
delivery.
(B) Storage . When pesticide products are stored in bulk
containers, whether mobile or stationary, which remain in the
custody of the user, a copy of the label of labeling, including
all appropriate directions for use, shall be securely attached to
the container in the immediate vicinity of the discharge control
valve.
(5) False or misleading statements . Pursuant to section
2(q)(1)(A) of the Act, a pesticide or a device declared subject
to the Act pursuant to § 162.15, is misbranded if its labeling is
false or misleading in any particular including both pesticidal
and non—pesticida]. claims. Examples of statements or representations
in the labeling which constitute misbranding include:
C l) A false or. mlsleading statement concerning the composition
of the product;
(ii) A false or misleading statement concerning the effectiveness
of the product as a pesticide or device;
(iii) A false or misleading statement about the value of the
product for purposes other than as a pesticide or device;
(iv) A false or misleading comparison with other pesticides or
devices;
(v) Any statement directly or indirectly Implying that the
pesticide or device is recommended or endorsed by any agency of
the Federal Government;
(vi) The name of a pesticide which contains two or more
principal active ingredients if the name suggests one or more but
not all such principal active ingredients even though the names
of the other ingredients are stated elsewhere in the labeling;
(vii) A true statement used in such a way as to give a false
or misleading impression to the purchaser;
(viii) Label disclaimers which negate or detract from labeling
statements required under the Act and these regulations;
165
-------
(ix) Claims as to the safety of the pesticide or its ingredients,
including statements such as “safe,” “nonpoisonous,” “noninjurious,”
“harmless” or “nontoxj.c to humans and pets” with or without such
a qualifying phrase as “when used as directed”; and
(x) Non—numerical and/or comparative statements on the safety
of the product, including but not limited to:
(A) “Contains all natural ingredients”;
(B) “Among the least toxic chemicals known”
(C) “Pollution approved”
(6) Final printed labeling . (i) Except as provided in
paragraph (a)c 6)(ii) of this section, final printed labeling must
be submitted and accepted prior to registration. However, final
printed labeling need not be submitted until draft label texts
have been provisionally accepted by the Agency.
(11) Clearly legible reproductions or photo reductions will be
accepted for unusual labels such as those silk-screened directly
onto glass or metal containers or large bag or drum labels. Such
reproductions must be of microfilm reproduction quality.
(b) Name, brand, or trademark . (1) The name, brand, or
trademark under which the pesticide product is sold shall appear
on the front panel of the label.
(2) No name, brand, or trademark may appear on the label which:
(1) Is false or misleading, or
(ii) I-las not been approved by the Administrator through
registration or supplemental registration as an additional name
pursuant to § 162.6(b)(4).
(c) Name and address of producer, registrant, or person for
whom produced. An unqualified name and address given on the
label shall be considered as the name and address of the producer.
If the registrant’s name appears on the label and the registrant
is not the producer, or if the name of the person for whom the
pesticide was produced appears on the label, it must be qualified
by appropriate wording such as “Packed for ***,“ “Distributed by
or “Sold by ***“ to show that the name Is not that of the
producer.
Cd) Net weight or measure of contents . (1) The net weight or
measure of content shall be exclusive of wrappers or other
materials and shall be the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide is a liquid, the net content statement
shall be in terms of liquid measure at 68°F (20°C) and shall be
expressed in conventional American units of’ fluid ounces, pints,
quarts, and gallons.
(3) If the pesticide is solid or semisolid, viscous or
pressurized, or is a mixture of liquid and solid, the net content
statement shall be in terms of weight expressed as avoirdupois
pounds and ounces.
(U In all cases, net content shall be Stated- in terms of the
largest suitable units, i.e., “1 pound 10 ounces” rather than
“26 ounces.”
166
-------
(5) In addition to the required units specified, net content
may be expressed in metric units.
(6) Variation above minimum content or around an average is
permissible only to the extent that it represents deviation
unavoidable in good manufacturing practice. Variation below a
stated minimum is not permitted. In no case shall the average
content of the packages in a shipment fall below the stated
average content.
Ce) Product registration number . The registration number
aáslgned to the pesticide product at the time of registration
shall appear on the label, preceded by the phrase “EPA Registration
No.,” or the phrase “EPA Reg. No.” The registration number shall
be set In type of a size and style similar to other print on that
part of the label on which it appears and shall run parallel 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 establishments registration number . The producing
establishment registration number preceded by the phrase ‘!EPA
Est.”, of the final establishment at which the product was produced
may appear in any suitable location on the label or Immediate
container. It must appear on the wrapper or outside container of
the package if the EPA establishment registration number on the
immediate container cannot be clearly read through such wrapper
or container.
(g) Ingredient statement——(l) General . The label of each
pesticide product must bear a statement which contains the name
and percentage by weight of each active Ingredient, the total
percentage by weight of all inert ingredients; and if the pesticide
contains arsenic in any form, a statement of’ the percentages of
total and water—solublearsenjc calculated as elemental arsenic.
The active ingredients must be designated by the term “active
ingredients” and the inert ingredients by the term “inert
ingredients,” or the singular forms of these terms when appropriate.
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 contain 100 percent
active ingredients. Unless the ingredient statement is a complete
analysis of the pesticide, the term “analysis” shall not be used
as a heading for the.ingredient statement.
(2) Position of ingredient statement . (i) The ingredient
statement is normally required on the front panel of the label.
If there Is an outside container or wrapper through which the
Ingredient statement cannot be clearly read, the ingredient
statement must also appear on such outside container or wrapper.
If the size or form of the package makes it impracticable to place
the Ingredient statement on the front panel of the label, permission
may be granted for the ingredient statement to appear elsewhere.
(ii) The text of’ the ingredient statement 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.
167
-------
(3) Names to be used in ingredient statement . The name used
for each ingredient shall be the accepted common name, if there
is one, followed by the chemical name. The common name may be
used alone only if it is well known. If no common name has been
established, the chemical name alone shall be used. In no case
will the use of a trademark or proprietary name be permitted unless
such name has been accepted as a common name by the Administrator
under the authority of Section 25(c)(6).
( t i) Statements of percentages . The percentages of ingredients
shall be stated In terms of weight-to—weight. The sum of per-
centages of the active and the inert ingredients shall be 100.
Percentages shall not be expressed by a range of values such as
tI 22 _ 25 %•t If the uses of the pesticide product are expressed as
weight of active ingredient per unit area, a statement of the
weight of active ingredient per unit volume of the pesticide
formulation shall also appear in the ingredient statement.
(5) Accuracy of stated percentages . The percentages given
shall be as precise as possible reflecting good manufacturing
practice. If there may be unavoidable variation between manu-
facturing batches, the value stated for each active ingredient
shall be the lowest percentage which may be present.
(6) Deterioration . Pesticides which change in chemical
composition slgnlflc’antly must meet the following labeling re-
quirements:
(1) In cases where it is determined that a pesticide formulation
changes chemical composition significantly, the product must bear
the following statement In a prominent position on the label: “Not
for sale or use after [ date].”
(ii) The product must meet all label claims up to the expiration
time indicated on the label.
(7) Inert Ingredients . The Administrator may require the name
of any Inert ingredient(s) to be listed in the ingredient statement
if he determines that such Ingredient(s) may pose a hazard to man
or the environment.
(i-i) Warnings and precautionary statements . Required warnings
and precautionary statements concerning the general areas of
toxicological hazard including hazard to children, environmental
hazard, and physical or chemical hazard fall into two groups; those
required on the front panel of the labeling and those which may
appear elsewhere. Specific requirements concerning content,
placement, type size, and prominence are given below.
(1) Required front panel statements . With the exception of the
child hazard warning statement, the text required on the front
panel of the label is determined by the Toxicity Category of the
pesticide. The category is assigned on the basis of the highest
hazard shown by any of the indicators In the table below:
168
-------
I
I
Hazard Indicators
I
loxicity categories
f ii
iii
J iv
I
I
Oral ID
5°
Up to and
including
50mg/kg
From 50 thru
500 mg/kg
From 500 thru
5000 mg/kg
I
I Greeter than
I 5000 mg/kg
I
I
I
I
Inhalation IC Up to end
Including
I .2mg/liter
From .2 thru
2 mg/liter
I
I
From 2 1hru
20 mg/liter
Greeter than
I 20 mg/lIter I
I I
I
Dermal 1D5°
Up to and
including
From 200 From 2.000 thru
thru 2000 20,000
Greeter then
20,000 I
I
200mg/kg
I
I
I
r
I
Eye effects
Corrosive;
Corneal opacity
P40 corneel opacity; P40 irritation
corneal opec ty
reversible
irritation
I
I
not reversible
withIn 7 days;
reversible
I
j
within 7 days
Irritation wIthin 7 days
-
I
persisting for I I
I
I
7days
Severe Irritation
at 72 hours
I I
I I
Skin effects J
Corrosive
I
I
Moderate irritation Mild or slight I
at 72 hours irritation all
I 72hours I
I I
(i) Human hazard signal word.——(A) Toxicity Cateaory I . All
pesticide products meeting the criteria of Toxicity Category I
shall bear on the front panel the signal word “Danger.” In
addition if the product was assigned to Toxicity Category I on
the basis of its oral, inhalation or derinal toxicity (as distinct
from skin and eye local effects) the word “Poison” shall appear
in red on a background of distinctly contrasting color and the
skull and crossbones shall appear in immediate proximity to the
word “poison.”
(B) Toxicity Category II . All pesticide products meeting the
criteria of Toxicity Category II shall bear on the front panel
the signal word “Warning.”
(C) Toxicity Category III . All pesticide products meeting the
criteria of Toxicity Category III shall bear on the front panel
the signal word “Caution.”
(D) Toxicity Catecory IV . All pesticide products meeting the
criteria of Toxicity Category IV shall bear on the front panel
the signal word “Cautions ”
169
-------
(E) Use of signal words . Use of any signal word(s) associated
with a higher Toxicity Category is not permitted except when the
Agency determines that such labeling is necessary to prevent
unreasonable adverse effects on man or the environment. In no
case shall more than one human hazard signal word appear on the
front panel of a label.
(ii) Child hazard warning . Every pesticide 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, marketing, 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 Administrator waive this
requirement.
(iii) Statement of practical treatment——(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 falling into Toxicity Category I on the basis of oral,
inhalation or derrnal toxicity. The Agency may, however, permit
reasonable variations in the placement of the statement of
practical treatment is some reference such as “See statement of
practical treatment on back panel” appears on t he front panel
near the word “Poison” and .the skull and crossbones.
(B) Other toxicity categories . The statement of practical
treatment is not required on the front panel except as described
in paragraph (h)(l)(iii)(A) of this section. The applicant may,
however, include such a front panel statement at his option.
Statements of practical treatment are, however, required elsewhere
on the label in accord with paragraph (h)(2) of this section if
they do not appear on the front panel.
(iv) Placement and prominence . All the required front panel
warning statements shall be grouped together on the label, and
shall appear with sufficient 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 requirements for the
front panel warning statements on various sizes of labels:
Size of label front panel
In square inches
Points
Required
signal word,
all capitals
“Keep out
of reach of
Children”
5andunder.... . . ... ..
Above 5 to 10 . . . . . . . . . .
Abovelotol5 .........
Above l5to3O .
Over 30 . . . . . . . . . . . . .
6
10
12.
1 4
18
6
6
8
10
12
170
-------
(2) Other required warnings and precautionary statements . The
warnings and precautio.nary statements as required below shall appear
together on the label under the general heading “Precautionary
Statements” and under appropriate subheadings of “Hazard to Humans
and Domestic Animals,” “Environmental Hazard” and “Physical or
Chemical Hazard.”
(i) Hazard to humans and domestic animals . (A) 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. The precautionary paragraph shall be immediately
preceded by the appropriate hazard signal word.
(B) The following table deptcts typical precautionary statements.
These statements must be modified or expanded to reflect specific
hazards.
I Precautionary statements by toxicity category
lox city
category J
Oral, inhalation, or dermal toxicity
Skin and eye local effects
I
I
t . . .f Fatal Cpoisonous if swallowed (Inhaled or
Corrosive, causes eye and skin donage br
I absorbed through skini. Do not breathe skin irritatloni. Do not get in eyes, on
-
I vapor idusti or spray misti. Do not get
skin, or on clothing. Wear goggles or face
in eyes, on skin, or on clothing iFront shield and rubber gloves when handling.
panel statement of practical treatment Harmful or fatal if swallowed.
required.1. lAppropriate first aid statement required.I
I ii . . . May be fatal if swallowed (inhaled or Causes eye [ and skini irritation. Do not
I absorbed through the skini. Do not breathef get in eyes, on skin, or on clothing.
I I vapors (dust or spray misti. Do not get m l Harmful if swallowed. (Appropriate first
I eyes, on skin, or on clothing. (Appropriatel aid statement reguired.l.
first aid statements r u1red.i. I
iii . . . Harmful if swallowed (inhaled or absorbed Avoid contact with skin, eyes or clothing.
-
through the skini. Avoid breathing vapors
In case of contact liemed lately flush
I
(dust or spray misti. Avoid contact with eyes or skin with plenty of water. Get
I skin [ eyes or clothingi. [ Appropriate medical attention if irritation persists.
f first aid statement required.I. I
I i v . . .f [ No precautionary statements required.I.
(No precaufioncry statements reguired.!.
- 1
I
(ii) Environmental hazards . 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
171
-------
damage. Examples of the hazard statements and the circumstances
under which they are required follow:
(A) If a pesticide intended for outdoor use contains an active
ingredient with a mammalian acute oral LD 50 of 100 or less, the
statement “This Pesticide is Toxic to Wildlife” is required.
(B) If a pesticide intended for outdoor use contains an active
ingredient with a fish acute LC 50 of 1 ppm or less, the statement
“This Pesticide is Toxic to Fish” is recuired.
(C) If a pesticide intended for outdoor use contains an active
ingredient with an avian acute oral LD 50 of 100 mg/kg or less, or
a subacute dietary LC 50 of 500 ppm or less, the statement “This
Pesticide is Toxic to Wildlife” is required.
(D) If either accident history or field studies demonstrate
that use of the pesticide may result in fatality to birds, fish
or mammals, the statement “This pesticide is extremely toxic to
wildlife (fish)” is required.
CE) For uses involving foliar application to agricultural
crops, forests, or shade trees, or for mosquito abatement
treatments, pesticides toxic to pollinating insects must bear
appropriate label cautions.
(F) For all outdoor uses other than aquatic applications the
label must bear the caution “Keep out of lakes, ponds or streams.
Do not contaminate water by cleaning of equipment or disposal of
wastes.”
(iii) Physical or chemical hazards . Warning statements on the
flammability or explosive characteristics of the pesticide are
required as follows:
I I
Flash point Reauired text
I I
(A) PRESSURIZED CONTAINERS I
I I
Flash point at or below 20 ’F; If there is a J Extremely flammable. Contents under pressure.
flashback at any valve opening. Keep away from fire, sparks, and heated
surfaces. Do not puncture or incinerate I
Con ainer. Exposure to temperatures above
I 3OF may cause bursting. I
Flash point above 20 ’F and not over 8O F or if Flammable. Contents under pressure. Keep away
the flame extension is more than 18 in. long from heat, sparks, end open flame. Do not
at a distance of 6 In. from The flame, puncture or incinerate container. Exposure toj
j temperatures above 130’F may cause bursting.
All other pressurized containers . . . . . . . Contents under pressure. Do not use or store
near heat or open flame. Do not puncture or
I incinerate container. Exposure to tempera—
fures above 130 ’F may cause bursting.
(9) P4ONPRESSIPIZED CONTAINERS I
I
I
I
-
Al or below 20’F . . . . . . . . . . . . . . . . Extremely flammable. Keep away from fire,
sparks, and heated surfaces. I
Above 2O F and not over 80F . . . . . . . . . • Flammable. Keep away from heat and open flame.
Above 80’F and not over 150 ’F . . . . . . . . •j
Do not use or store near heat or open flame.
172
-------
(1) Directions for Use——Cl) General requirements——Cl) Adequacy
and clarity of directions . 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.
(11) Placement of directions for use . Directions may appear
on any portion of the label provided that they are conspicuous
enough to be easily read by the user of the pesticide product.
Directions for use may appear on printed or graphic matter which
accompanies the pesticide provided that:
(A) If required by the Agency, such printed or graphic matter
is securely attached to each package of the pesticide, or placed
within the outside wrapper or bag;
(B) The label bears a reference to the directions for use in
accompanying leaflets or circulars, such as “See directions In
the enclosed circular.” and
(C) The Administrator determines that it is not necessary for
such directions to appear on the label.
(i ii) Exceptions to requirement for direction for use——(A )
Detailed directions for use may be omitted from labeling of
pesticides which are intended for use only by manufacturers of
products other than pesticide products in their regular rnanu—
facturing processes, provided that:
(1) The label clearly shows that the product is intended for
use only in manufacturing processes and specifies the type(s) of
products involved.
(2) Adequate information such as technical data sheets or
bulletins, is available to the trade specifying the type of
product involved and its präper use in manufacturing processes;
(3) The product will not come Into the hands of the general
public except after incorporation into finished products; and
(14) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(B) Detailed directions for use may be omitted from the labeling
of pesticide products for which sale is limited to physicians,
veterinarians, or druggists, provided that:
(1) The label clearly states that the product is for use only
by physicians or veterinarians;
(2) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment; and
(3) 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’ pesticide products which are intended for use, only by formulators
in preparing pesticides for sale to the public, provided that:
(1) There is information readily available to the formulators
on the composition, toxicity, methods of use, applicable restrictions
or limitations, and effectiveness of the product for pesticide
purposes;
173
-------
(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 products
involved;
(3) The product as finally manufactured, formulated, mixed, or
repackaged is registered; and
(LI) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(2) Contents of Directions for Use . The directions for use
shall Include the following, under the headings tt Directlons for
Use”:
(1) The statement of use classification as prescribed in
1 6 2.lO(j) immediately under the heading “Directions for Use.”
(ii) Immediately below the statement of use classification,
the statement “It is a violation of Federal law to use this
product in a manner inconsistent with its labeling.”
(iii) The site(s) of application, as for example the crops,
animals, areas, or objects to be treated.
(iv) The target pest(s) associated with each site.
(v) The dosage rate associated with each site and pest.
(vi) The method of application, including instructions fQr
dilution, if required, and type(s) of pp1icatIon apparatus or
equipment requried.
(vii) The frequency and timing of applications necessary to
obtain effective results without causing unreasonable adverse
effects on the environment. -
(viii) Specific limitations on reentry to areas where the
pesticide has been applied, meeting the requirements concerning
reentry provided by 140 CFR Part 170.
(ix) Specific directions concerning the storage and disposal
of the pesticide and its container, meeting the requirements of
140 CFR Part 165. These instructions shall be grouped and appear
under the heading “Storage and Disposal.” This heading must be
set in type of the same minimum sizes as required for the child
hazard warning (See Table in § 162.10(h)(1)(lv).)
(x) Any limitations or restrictions on use required to prevent
unreasonable adverse effects, such as:
(A) Required intervals between application 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 physically 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
applicator who is physically present.
174
-------
(F) Other pertinent Information which the Administrator
determines to be necessary for the protection of man and the
environment.
(j) Statement of Use Classification . By October 22., 1976, all
pesticide products must bear on their labels a statement of use
classification as described in paragraphs (j)(i) and (2) of this
section. Any pesticide product for which some uses are classified
for general use and others for restricted use shall be separately
labeled according to the labeling standards set forth In this
subsection, and shall be marketed as separate products with
different registration numbers, one bearing directions only for
general use(s) and the other bearing directions for restricted
use(s) except that, if a product has both restricted use(s) and
general use(s), both of these uses may appear on a product labeled
for restricted use. Such products shall be subject to the
provisions of’ § 162.lO(j)(2). -
(1) General Use Classification . Pesticide products bearing
directions for use(s) classified general shall be labeled with
the exact words “General Classification” immediately below the
heading “Directions for Use.” And reference to the general
classification that suggests or implies that the general utility
of the pesticide extends beyond those purposes and uses contained
in the Directions for Use will be considered a false or misleading
statement under the statutory definitions of’ misbranding.
(2) Restricted Use Classification . Pesticide products bearing
direction for use(s) classified restricted shall bear statements
of restricted use classification on the front panel as described
below: -
(i) Front panel statement of restricted 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 § 162.1O(h)(1)(jv)), and appearing with sufficient
prominence relative to other text and graphic material on the
front panel to make it unlikely to be overlooked under customary
conditions of purchase and use, the statement “Restricted Use
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 Certcified Applicators or persons under
their direct supervision and only for those uses covered by the
Certified Applicator’s certiTicatlon.” If, however, other
regulatory restrictions are lmposed, the Administrator will define
the appropriate wording for the terms of restriction by regulation.
(k) Advertising. [ Reserved]
[ Lb FR 28268, July 3, 1975; 140 FR 32329, Aug. 1,1975; 1 10 FR
38571, Aug. 21, 1975, as amended at 143 FR 5786,- Feb. 9, 1978]
175
-------
APPENDDC IV-2
LABELING REQUIREME OF THE FIFRA, AS AMENDED
ITE 4
LABEL ELEMEWP
APPLICABILITY
OF REQUIREME1f
PLACE 4Et 1 ON LABEL
COMNFJ IPS
REQUIRED
PREFERRED
1
Product name
All products
Front panel
Center front
panel
2
Ccinpany name
arid address
All products
None
Bottczn front
panel or end
of label text
If r ist rant is not the producer, must
be qualified by “Packed for . .
“Distributed
3
Net contents
All products
None
Bottczn front
panel or eril
of_label_text
by. . .,“ etc.
Pv y be in metric units in addition to
U.S. units
lj
EPA Reg. No •
All products
None
Front panel
Must be in similar type size arid run
parallel to other
5
EPA Est. No.
All products
None
Front panel,
I mmediately
before or
fol 1 owIng
Reg. No.
type.
y appear on the container instead of
the label.
6A
Ingredients
stat nent
All products
Front panel
Immediately
following
product name
Text must run parallel with other text
on the panel.
6B
F unds/gallon
statament
.
Liquid products
where dosage
given as lbs.
al/unit area
Front panel
Directly below
the main
Ingredients
statement
7
Front panel
precautionary
statements
All products
.
Front panel
.
All front panel precautionary statements
must be grouped tcgether, preferably
blocked.
7A
Keep (lit of Reach
of Children
(Child hazard
warning)
All products
Front panel
Above signal
word
Note type size requirements.
7B
Signal word
All products
Front panel
IrrniedIately
below child
hazard
warning
Note type size requirements.
176
-------
APPENDIX P1-2 (continued)
ITEM
LABEL ELEMENT
APPLICABILITY
OF R UIREMEWP
PLACEMENT ON LABEL
RR UIRED
PREFERRED
7C
Skull & cross—
bones and word
FOISON (in red)
All products
which are Cat-
egory I based
on oral, der—
mal, or inhala-
tion toxicity
Front panel
BDth in close
proximity to
signal word
.
COMMEr 1rS
7D
Statement of
practical
treatment
All products
in Categories
I, II, and III
Category I:
Front panel
unless refer-
ral statement
Is used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel
for all.
7E
Referral
statement
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
Front panel
8
Side/back panel
precautionary
statements
All products
None
¶flp or side
of back panel
preceding
directions
for use
f4 st be grouped under the headings in
8A, 8B , and 8C; preferably blocked.
BA
Hazards to
huiians and
dciiiestlc
animals
All products
in Categories
I, II, and III
None
Same as above
ftist be preceded by appropriate signal
iword.
88
E ivirorinental
hazards
All products
None
Same as above
Ehvirormental hazards include bee
caution where
177
-------
APPENDIX IV-2 (continued)
ITEM
LABEL ELEME IT
APPLICABILITY
OF REY UIREMEt Ir
PLACEMENT ON LABEL
COMMF1 I S
RFI UIRED
PREFERRED
BC
Physical or
ch nical
hazards
All pressurized
products, others
with flash
points under
150°F
1 bne
Same as above
9A
Restricted
block
All restricted
products
‘Ibp center
of front
panel
Preferably
blocked
Includes a statanent of the tenna of
restriction. The words IIRESIRICIIED USE
F’ESTICIE€’ must be same type size as
signal word.
9C
.
Misuse
eta ta nent
All products
Immediately
following
heading of
directions
for use
.
1OA
Reentry
statanent
All
cholinesterase
inhibitors
In the
directions
for use
Ininediately
after misuse
statament
bC
Stor e and
disposal block
All products
In the
directions
for use
Immediately
before
specific
directions
for use or
at the end of
directions
for_use
!4ist be set aç rt and clearly distin—
gulahable fran fran other directions
for use.
1OD
Directions
for_use
All products
1’bne
bne
1 y be In metric as l1 as U.S. units
178
-------
Appendix IV-3
PHYSICAL-CHEMICAL
HA ZARDS
Criteria
Required Label Statement
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. ALL OTHER PRESSURIZED
CONTAINERS
II. Non—Pressurized Containers
A. Flashpolnt at or below
20°F.
• B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
&nd heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
179
-------
Appendix IV—LI
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 label 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:
Required type size
Size of label for the heading
front panel in STORAGE AND DISPOSAL -
square inches (all capitals)
10 and under 6 point
Above 10 to 15 . . . .8 point
Above 15 to 30 . . . . . 10 point
Over 30 . . 12 point
Storage and disposal instructions mu2t 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 : -
Au 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.
180
-------
Appendix IV-ZI
(continued)
14 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:
“Pestlcide 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, O CFR
261 for a hazardous waste must bear the following pesticide
disposal statement:
181
-------
Appendix IV-14
(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 .“
3. 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—a roso1 products
(bottles, cans, jars)
Do not reuse container (bottle, can, Jar).
Rinse thoroughly before discarding in trash.
Non—aerosol products
(bags)
Do not reuse bag. Discard bag in trash.
Aerosol products
Replace cap and discard containers in
trash. Do not incinerate or puncture.
182
-------
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
1, Manufacturer may replace this phrase with one Indicating
whether and how fiber drum may be reused.
Metal
containers
(non—aerosol)
Triple rinse (or equivalent). Then offer I
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Plastic containers
Triple rinse (or equivalent) . Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
Incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke. -
Glass containers
Triple rinse (or equivalent) . Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Fiber drums
with liners
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. E npty 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
reused!, dispose of in the same manner.
Paper and
plastic bags
.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Compressed gas
cylinders
Return empty cylinder for reuse (or
similar wording)
183
-------
Appendix IV—k
(continued)
Pesticides that are hazardous wastes under O CFR 261.33(e) and (f)
when discarded.
“ Acutely Hazardous” Commercial Pesticides (RCRA “E” List)
Active Ingredients, (no inerts) :
Acrolein
Aldicarb
Aidrin
Allyl alcohol
Aluminum phosphide
I-Aminopyridine
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p—Ch loroanlljne
Cyanides (soluble cyanide salts, not specified elsewere)
Cyanogeri chloride
2—Cyclohexyl-1, 6 —dinitrophenol
Dieldrin
0,0—Diethyl S— [ 2-ethylthio)ethyl] phosphorodithioate
(disulfoton, Di—Syston)
0,0—Diethyl O—pyrazinyl phosphorothioate (Zinophos)
Dimethoate
0,0—Dimethyl O—p—nitrophenyl phosphorothioate (methyl parathion)
4 , 6 —Dinitro—o—cresol and salts
‘ , 6—Dinitro—o—cyclohexylphenol
2, 4 Dinitrophenol
Dinoseb -
Endos ulfan
End othal 1
Endrin
Pam phur
Fluo roacetamide
He pta c hi or
Hexanethyl tetraphosphate
Hydr’ocyanic acid
Hydrogen cyanide
Methomyl
alpha—Maphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramlde (OMPA, schradan)
Parathion
184
-------
Appendix IV—L
(continued)
“ Acutely Hazardous” Commercial Pesticides (RCRA “E” List)
Active Ingredients continued :
Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
Strychnine and salts
O,O,O,O—Tetraethyl dithiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate
Thallium sulfate
Thiofanox
Toxaphene
War far in
Zinc phosphide
185
-------
Appendix IV- 4
(continued)
“ Toxic” Commercial Pesticide Products (RCRA “F” List)
Active Ingredients :
Acetone
Ac ryionltr lie
Am i t role
Benzene
Bis( 2—ethyihexyl ) pthalate
Cacodyllc acid
Carbon tetrachioride
Chioral (hydrate)
Chiordane (technical)
Chlorobenzene
4—Chioro—m—cresol
Chlorofor n
o—Chlorophenol
1 —Chloro—o--toluidjne hydrochloride
Creosote
Cresylic acid
Cyc lohexane
Decachlorooctahydro—j. , 3, 1 —metheno-2H-cyclobuta [ c ,d]—pentalen—2-one
(keporie, chiordecone)
i,2—Dibromo—3—chloropropane (DBCP)
Dibutyl phthalate
S—3,3—(Dichloroallyl diisopropylthiocarbamate (diallate, Avadex)
o—Dlchlorobenzene
p—Dichloroberizene
Dichiorodifluoromethane (Freon l2 )
3,5—Dichloro—N—(l,l—dimethyl—2—propynyl) benzamlde (pronainlde,Kerb)
Dichioro diphenyl dichioroethane (DDD)
Dichioro diphenyl tr’ichloroethane (DDT)
Dichiorethyl ether
2, 1 4—Dichlorophenoxyacetic, esters and salts (2,4—D)
1 ,2—Dichloropropane
1 ,3—Dichloropropane (Telone)
Dimethyl phthalate
Ethyl acetate
Ethyl L,Zt’ dichlorobenzllate (chlorobenzilate)
Ethylene dibromide (EDB)
Ethylene dichioride
Ethylene oxide
Fo rrnald ehyd e
Furl ural
Hexachlorobenzene
Hexachlorocyclopentadiene
Hexachloroethane
Hydrofluoric acid
186
-------
Appendix IV-Zi
(continued)
“ Toxic” Commercial Pesticide Products (RCRA “F” List)
Active Ingredients :
Isobutyl alcohol
Lead acetate
Lindane
Maleic hydrazide
Mercury
Methyl alcohol
Methyl bromide
Methyl chloride
2,2’—Methylenebis (3, 1 ,6—trich1oropheno1) (hexachiorophene)
Methylerie chloride
Methyl ethyl ketone
L _Methyl...2...pentanone (methyl isobutyl ketorie)
Naphthalene
Nitrobenzene
p—Ni trophenol
Pen tachl oroethane
Pentachloronltrobenzene (PCNB)
Pentaclorophenol
Phenol
Phosphorodithioje acid, O,0-dlethyl, methyl ester
Propylene dichioride
Pyridine
Resorcinol
Saf role
Selenium disulfide
Silvex
F, 2, 4 , 5—Tetrachlorobenzerie
1 ,l,2,2—Tetrachloroethane
Tetrachioroethylene
2,3, 1 4,6—Tetrachlorophenol
Thiram
Toluene
1,1 ,l—Trichloroetharie
Trlchloroethylene
Trichloromonof].uoromethane (Freon il®)
2, 1 1,5—Trichlorophenol
2, 11, 6—Trichiorophenol
2, 4 ,5—Trichlorophenoxyacetjc acid (2,4,5—T)
Xylene
187
-------
Appendix IV— i
(continued)
“ Toxic” Commercial Pesticide Products (RCRA “F” List)
Inert Ingredients :
Acetone
Acetonitrile
Acetophenone
Acrylic acid
Aniline
Benzene
Chlorobenzene
Chloroform
Cyclohexane
Cyclohexanone
Dichiorodifluoromethane (Freon l2 )
Diethyl phthalate
Dime t h yl am in e
Dimethyl phthalate
1 , 1 —Dioxane
Ethylene oxide
Formaldehyde
Formic acid
Isobutyl alcohol
Meleic anhydride
Methyl alcohol (methanol)
Methyl ethyl ketone
Methyl methacrylate
Naphtha lene
Saccharin and salts
Th lour ea
Tol uene
1,1 ,l—Trlchloroethańe
1,1 ,2—Trlchloroethane
Trichiorofluorornethane (Freon 11
Vinyl chloride
Xylene
188
------- |