&EPA
Environawntal Protection
Agency
Office of
Pvcticidet and Toxic Subrtwiow
Guidance for the
Reregistration of
Pesticide Products
Containing DIMETHYL TETRA
CHLOROTEREPHTHALAT
as the Active Ingredient
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GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING DCPA AS THE ACTIVE INGREDIENT
DCPA
(078701)
CASE NUMBER 0270
CAS 1861-32-1
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
June, 1988
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TABLE OF CONTENTS
I. Introduction
II.. Chemical(s) Covered by this Standard
A. Description of Chemical
B. Use Profile
III. Agency Assessment 6
A. Summary
B. Preliminary Risk Assessment
C. Other Science Findings
D. Tolerance Reassessment
IV. Regulatory Assessment 21
A. Regulatory Positions & Rationales
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V- Products Subject to this Standard 32
VI. Requirements for Submission of Generic Data ... 34
A. What are generic data?
B. Who must submit generic data?
C. What generic data must be submitted?
D. How to comply with DCI requirements
E. Procedures for requesting a change in
protocol
F. Procedures for requesting extensions of time
G. Existing stocks provisions upon suspension
or cancellation
VII. Requirement for Submission of
Product-Specific Data 40
VIII. Requirement for Submission of Revised Labeling . . 41
IX. Instructions for Submission 41
A. Manufacturing use products (sole active)
B. Manufacturing use products (multiple active)
C. End use products
D. Intrastate products
E. Addresses
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APPENDICES
I. DATA APPENDICES 45
Guide to Tables 46
Table A 48
Table B 83
II. LABELING APPENDICES 89
Summary of Label Requirements 90
III. USE INDEX APPENDIX 98
IV- BIBLIOGRAPHY APPENDICES 128
Guide to Bibliography 129
Bibliography 131
V. FORMS APPENDICES 135
EPA Form 8580-1 FIFRA S3(c)(2)(B) Summary Sheet. 136
EPA Form 8580-6 Certification of Attempt to Enter Into
an Agreement with Other Registrants for
Development of Data 137
EPA Form 8580-4 Product Specific Data Report . . 138
EPA Form 8570-27 Formulator's Exemption Statement 140
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. Also known as the Reference
Dose or RfD.
a.i. active ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CSF Confidential Statement of Formula
EEC Estimated Environmental Concentration. The estimated
pesticide concentration system in an environment,
such as a terrestrial ecosystem.
EP End Use Product
EPA U.S. Environmental Protection Agency
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
LC50 Median lethal concentration - a statistically derived
cone en t r a t i on of a substance that can be expected to
cause death Tn 50% of test animals. It is usually
expressed as the weight of substance per weight or
volume of water or feed, e.g., mg/1 or ppm.
LD50 Median lethal dose - a statistically derived single dose
than can be expected to cause death in 50% of the test
animals, when administered by the route indicated
(oral, dermal, inhalation). It is expressed as a
weight of substance per unit weight of animal, e.g.,
nig/kg.
LEL Lowest Effect Level
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of
recording and tracking studies submitted to the Agency.
MP Manufacturing Use Product
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
OPP Office of Pesticide Programs
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OES Office of Endangered Species, U.S. Fish and Wildlife
Service
PADI Provisional Acceptable Daily Intake
ppm parts per million
RfD Reference Dose
TMRC Theoretical Maximum Residue Contribution
iv
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I. INTRODUCTION
EPA has established the Registration Standards program
in order to provide an orderly mechanism by which pesticide
products containing the same active ingredient can be reviewed
and standards set for compliance with FIFRA. The standards
are applicable to reregistration and future applications for
registration of products containing the same active ingredient.
Each registrant of a product containing an active ingredient
subject to this Standard who wishes to continue to sell or
distribute that product must bring his product and labeling
into compliance with FIFRA, as instructed by this Standard.
The Registration Standards program involves a thorough
review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable
adverse effects" criteria of FIFRA. In its review EPA identifies:
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the pesticide.
2. Additional studies necessary to support continued
registration. The additional studies may not have been
required when the product was initially registered or may be
needed to replace studies that are now considered inadequate.
3. Labeling revisions needed to ensure that the product
is not misbranded and that the labeling is adequate to protect
man and the environment.
The detailed scientific review, which is not contained
in this document, but is available upon request1, focuses on
the pesticide active ingredient. The scientific review
primarily discusses the Agency's evaluation of and conclusions
from available data in its files pertaining to the pesticide
active ingredient. However, during the review of these data
the Agency is also looking for potential hazards that may be
associated with the end use products that contain the active
ingredient. The Agency will apply the provisions of this
Registration Standard to end use products if necessary to
protect man and the environment.
scientific reviews may be obtained from the National
Technical Information Service, Port Royal Road, Springfield,
VA 22152 (Telephone No. 703-487-4650).
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EPA's reassessment results in the development of a
regulatory position, contained in this Registration Standard,
on the pesticide and each of its registered uses. See
Section IV - Regulatory Position and Rationale. Based on its
regulatory position, the Agency may prescribe a variety of
steps to be taken by registrants to maintain their registrations
in compliance with FIFRA. These steps may include:
1. Submission of data in support of product registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in
the issuance of a Notice of Intent to Cancel or a Notice of
Intent to Suspend (in the case of failure to submit data).
In addition, in cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154
to examine in depth the risks and benefits of use of the
pesticide. If the Agency determines that the risks of the
pesticide's use outweigh the benefits of use, the Agency
may propose additional regulatory actions, such as cancellation
of uses of the pesticide which have been determined to cause
unreasonable adverse effects on the environment.
EPA has authority under the Data Call-in (DCI) provisions
of FIFRA sec. 3(c)(2)(B) to require that registrants submit
data to answer our questions regarding the chemical, toxicological,
and environmental characteristics and fate of a pesticide.
This Registration Standard lists the data EPA believes are
necessary to resolve our concerns about this pesticide.
These data are listed in the Tables A, B. and C in Appendix I.
Failure to comply with the DCI requirements enumerated in
this Registration Standard may result in issuance by EPA of a
Notice of Intent to Suspend the affected product registrations.
Registrants are reminded that FIFRA sec. 6(a)(2) requires
them to submit factual information concerning possible unreason-
able adverse effects of a pesticide at any time that they
become aware of such information. Registrants must notify
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the Agency of any information, including interim or preliminary
results of studies, if that information suggest possible
adverse effects on man or the environment. This requirement
is independent of the specific time requirements imposed by
EPA for submission of completed studies called in by the
Agency and continues as long as a product is registered
under FIFRA.
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II. CHEMICAL COVERED BY THIS STANDARD
A. Description of Chemical
The following chemical is covered by this Registration
Standard:
Common name: DCPA
Chemical name: Dimethyl tetrachloroterephthalate
Chemical Family: Chlorinated Benzoic Acids
CAS Registry Number: 1861-32-1
OPP (Shaughnessy) Number: 078701
Empirical Formula: CioH6cl4°4
Trade Names:
Other Names:
Physical Characteristics:
Dacthal'
Chlorothal, chlorothal-dimethyl
B. Use Profile
Type of Pesticide:
Pests Controlled:
White Crystalline Solid
Molecular Weiqht: 332
Melting Point: 156 °C
Solubility: < 0.5 mg/L in water
100 g/L in Acetone
200 g/L in Benzene
170 g/L in Toluene
140 g/L in Xylene
Odor: odorless
Vapor Pressure: 0.01 mm Hg at 40 °C
Octanol/Water Partition Coefficient:
6.8 x 103 at 25 °C.
Stability: Stable when stored under
normal temperatures. Decomposes
at 360 to 370 °C. Stable to UV
radiation.
DCPA is a herbicide that is used to control
a broad spectrum of weeds when applied
preemergence to germinating weed seeds.
Mechanical incorporation or incorporation
by irrigation is not required to assure
effectiveness under most conditions of use.
Weeds in ornamental turf and in certain
vegetable and field crops.
Mechanism of Action: Inhibits root growth by modifying cell
division.
Predominant Uses:
DCPA is used in the selective control of
a broad spectrum of weed grasses (smooth
and hairy crabgrass, witchgrass, green and
yellow foxtailf fall panicum and others).
It is also effective in the selective
control of certain broadleaf weeds (carpet
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weed, dodder, purslane, nodding spurge,
prostrate spurge, spotted spurge and common
chickweed). These weeds may be selectively
controlled in ornamental turf, ornamental
plants, strawberries, seeded and trans-
planted vegetables, in cotton and soybeans
and in field beans.
Formulations: There are manufacturing use products (MPs) that
contain 50, 75 and 90 percent DCPA. There are
also wettable powders formulated with 25, 50, 60,
75 and 90 percent DCPA; and granular products
containing 1.15 to 24.0 percent DCPA.
Methods of Application: DCPA may be applied with either
ground or aerial equipment.
Registration History: DCPA was first registered under FIFRA
for use on turf grasses in 1958. The
first food-crop use was registered
on January 8, 1962. There are pre-
sently 148 products registered under
Section 3 (FIFRA), 14 products under
Section 24(c) and 15 intrastate products
are pending registration under FIFRA,
making a total of 177 products. Six
of these products are in combination
with other pesticidal active
ingredients.
Preliminary Quantitative Usage: Sixty-three percent (2 to 2.5
million pounds) is used on
turf sod farms, golf courses,
home lawns and on home gardens.
Thirty-one percent (1.0 to 1.2
million pounds) is used in the
culture of commercial vegetables
(lettuce, cole crops, onions,
sweet potatoes and others.)
Six percent (about 0.2 to one
million pounds) is used in
the culture of field crops
(primarily cotton). The total
annual usage of the active
ingredient DCPA is approxi-
mately 3.2 - 4.7 million
pounds.
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III. AGENCY ASSESSMENT
A. SUMMARY
The Agency has reviewed data submitted to support the registration
of dimethyl tetrachloroterephthalate (DCPA). Numerous data gaps
were identified and few definitive conclusions could be made.
Based on available data, the Agency has reached the following
interim conclusions which are discussed in detail in Section B,
which follows:
1. DCPA and its metabolites appear to have low acute and chronic
toxicity based on the limited studies that have been submitted
to support the presently registered pesticide products.
However these products contain 2,3,7,8-tetrachlorodibenzo-p-
dioxin (2,3,7,8-TCDD) and hexachlorobenzene (HCB) as impurities
from the manufacturing of technical DCPA. These impurities
have chronic toxicological properties (oncogenic, teratogenic,
fetotoxic, mutagenic and adverse affects on immune response
in mammals) that are of particular concern in the reregistration
of DCPA based pesticide products. The manufacturer of technical
DCPA has presented to the EPA information which indicated that
technical DCPA contains no greater than 0.1 part per billion (ppb)
2,3,7,8-TCDD and no greater than 0.3 percent HCB. The Agency
accepts this information until it is confirmed by analysis.
The Agency conducted a preliminary risk assessment based on
the assumption that exposure to the impurities will be propor-
tional to the exposure to DCPA. The estimates of risk obtained
in this risk assessment were low; however, the uncertainities
were high. Therefore, the Agency is requiring additional data
to reduce the uncertainities regarding exposure to the impurities.
When these data are received and reviewed, the risk will be
reevaluated.
2. Forty-five established tolerances for residues of DCPA in
raw agricultural commodities (40 CFR 180.185) are inadequately
supported by both residue chemistry and toxicology data.
Additional data in these areas are required.
3. The Agency's review identified missing data necessary to
evaluate the potential hazard to the environment and to human
health associated with the continued use of DCPA as an active
ingredient in pesticide products. The missing data are listed
as data gaps in the tables of Appendix I of this document, and
must be submitted in order to continue existing registration
of pesticide products containing DCPA and in order to register
new pesticide products that contain DCPA.
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The Agency has also determined that certain label restrictions
and revisions are necessary. These include:
Ingredient Statement
Precautionary Statements
Environmental Hazards Statements
Protective Clothing Requirements
Reentry Interval
The Regulatory Position and Rationale section discusses the
Agency's position on each of these restrictions and the Required
Labeling section contains the specific wording required for each
of the labelina revisions.
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B. PRELIMINARY RISK ASSESSMENT - DCPA/2,3,1,8-TCDD/HCB
1. DCPA
Numerous data gaps exist for DCPA and few definitive conclusions
can be made prior to receipt of the required data. Therefore,
only a hazard assessment will be presented for DCPA. Because
this assessment is based on the data available, it is subject to
change.
o Acute Tpxicity. DCPA did not produce dermal sensitization in
guinea pigs in a dermal sensitization study. There are no
other acute data. DCPA products have been placed in
Toxicity Category III and IV, based upon existing studies.
When acute data required by this Registration Standard are
submitted and reviewed, the Toxicity Category of DCPA will be
reevaluated.
o Subch.ronic Tox ic ity. The Agency has no data on the subchronic
oral, dermal, inhalation toxicity or neurotoxicity of DCPA.
An acceptable chronic oral study in dogs is adequate for the
required subchronic oral study in nonrodents. The chronic oral
study in dogs is discusssed below under chronic toxicity.
o Chronic Oral Toxicity.
a. Dog
EPA has an acceptable study on the chronic oral toxicity of
DCPA in dogs. In that study four male and four female beagle
dogs were dosed with DCPA at 100, 1,000, and 10,000 ppm in
their diet. One dog/sex/dose was sacrificed after one year
and the remaining three/sex/dose were carried for a total of
two years dosing. No compound-related effects were observed.
The NOEL was 10,000 ppm, the highest dose tested. The study
was deficient in terms of EPA Guideline testing protocols
because the number of dogs carried to termination was too
small and inadequate blood chemistry tests and histopathology
were performed. Because the study was terminated at 2 years
rather than at 1 year as currently required and there were no
toxic effects, the study is acceptable for a chronic oral
toxicity study in a nonrodent.
b. Rat
In a chronic toxicity study in rats, 35 male and 35 female rats
were dosed with DCPA at 100, 1,000 and 10,000 ppm in their
diets for 2 years. At termination of the study, the kidney
weights in males and the adrenal weights of females were
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2. Risk Assessment of the Manufacturing Impurities, 2,3,7,8-TCDD
and HCB
The manufacturer of technical DCPA has identified two impurities
2,3,7,8-tetrachlorodibenzo-p-dioxin (2,3,7,8-TCDD) at levels
of no greater than 0.1 ppb and hexachlorobenzene (HCB) at
levels of no greater than 0.3 percent. The Agency's concern
for the potential hazards from these low levels of impurities
in DCPA products is discussed below. EPA has classified both of
these impurities as Probable Human Carcinogens (Group B2).
a. Hazard Profile of 2,3,7,8-TCDD
Oncogenic; effects
In September, 1985, the Agency published a Health
Assessment Document for Polychlorinated Dibenzo-p-
dioxins (MRID-40543002). The conclusions from this
document were used to perform a preliminary risk
assessment for the impurity, 2,3,7,8-TCDD in DCPA
products. A brief summary of the qualitative and
quantitative oncogenic assessment from that document
is presented below. For an in-depth discussion refer
to Section 11 and Appendix B of the document.
EPA classified 2,3,7,8-TCDD as a Probable Human
Carcinogen (Group B2) based on "sufficient" animal
bioassay data and "inadequate" evidence of human
carcinogenicity (Refer to page 11 - 138 of the
Health Assessment Document).
Assuming that 2,3,7,8-TCDD is oncogenic in humans,
the Agency estimated an upper bound incremental unit
cancer risk. Three animal studies were adequate
for use in estimating the Qi (i.e., greatest potency).
The data are summarized as follows:
The Dow (1978) diet study on Sprague-Dawley rats,
Spartan substrain, produced significantly increased
cancers in the males, including stratified squamous
cell carcinomas of the tongue and squamous cell car-
cinomas of the nasal turbinates and hard palate.
There was a significant increase in number of cancers
in the lung, nasal turbinate and hard palate and liver
tumors of females. As with the males, the total number
of animals with at least one of these significant
tumors was recorded. Both the original pathological
analysis (Kociba) and that of an independent jeviewer
(Squire) were considered in estimating the Q^ .
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The NCI gavage studies in Osborne Mendel rats and B6C3F1
mice are summarized as follows:
(a) 2,3,7,8-TCDD in male rats caused an increase in
combined follicular cell adenomas and carcinomas combined
of the thyroid. However, these tumors were not considered
biologically significant for risk assessment purposes.
In females, the combined neoplastic nodules and hepato-
cellular carcinomas were considered significant, and
these data were used. The adrenal cortical adenomas or
carcinomas were not considered biologically significant.
(b) 2,3,7,8-TCDD in male mice caused an increase in hepato-
cellular carcinomas and in combined hepatocellular adenomas
and carcinomas. In female mice, 2,3,7,8-TCDD caused an
increase in subcutaneous tissue fibrosarcomas, lymphomas
or leukemias of the hematopoietic system, liver hepato-
cellular carcinomas and adenomas, and thyroid follicular
cell adenomas.
The Agency calculated the Q±* (i.e., potency) based on
multiple tumor sites in female Sprague-Dawley rats. The
slope estimates obtained by using the slide readings of
two different pathologists were averaged by taking the
geometric mean and the final estimate was as follows:
Q!* = 1.56 x 105 (mg/Kg/day)'1
Other^toxic effects
2,3,7,8-TCDD also has been shown to induce teratoaenic
effects in mice (NOEL 0.1 jjg/kg/day) and in rats (NOEL
0.03 lag/kg/day. In a 3-generation reproductive toxicity
study in rats, 2,3,7,8-TCDD caused reduced fertility, with
a NOEL of 0.001 £g/kg/day.
b. Hazard Profile of HCB
Oncogeni.c effects
In January, 1985, the Agency published a Health Assessment
Document for Chlorinated Benzenes (MRID-40543001). The
conclusions from this document were used to perform a pre-
liminary risk assessment from the impurity, HCB, in DCPA
pesticide products. A brief summary of the qualitative and
quantitative oncogenic assessment from that document is pre-
sented below. For an in-depth discussion, refer to Section
12 of the document. EPA classified HCB as a Probable Human
Carcinogen (Group B2) based on sufficient animal data in
the absence of human data of carcinogenicity (Refer to
page 12-120 of the Health Assessment Document).
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Assuming that HCB is oncogenic in humans, the Agency
estimated an upper-bound incremental unit cancer
risk. Four animaj studies were adequate for use in
estimating the Q^ (i.e., potency).
Fourteen data sets which show significant increases of
tumor incidences were used to calculate the carcinogenic
potency of HCB. These include hepatomas and hemangio-
endothelioma of the liver in both sexes and thyroid
adenomas in male Syrian golden hamsters (Cabral et. al.,
1977), hepatomas in both sexes in Swiss mice (Cabral et.
al., 1979), renal cell adenoma, hepatocellular carcinoma,
and hepatoma in both sexes of Sprague-Dawley rats
(Lambrecht, 1983) and adrenal pheochromocytoma in female
Sprague-Dawley rats (Arnold et. al., 1985). The Q±
obtained from the hepatocellular carcinomas in the female
Sprague-Dawley rats was used to calculate the cancer unit
risk in the health assessment document and will be used
to calculate the preliminary risk as a result of exposure
to HCB from the uses of DCPA pesticide products.
The estimate of greatest potency was determined to be:
Q!* = 1.7 (mq/Kg/dayr1
Other toxic effects
A 4-generation reproductive toxicity study of HCB in rats
produced a NOEL of 20 ppm (1 mg/kg/day). The primary toxic
effect observed was toxicity to the nursing pups. The
effect was lethal at higher doses. No teratogenic effects
were seen. The NOEL for maternal toxicity was 80 ppm
(4 mg/kg/day).
c. Risks from Dietary Exposure
Potential dietary exposures to the impurities 2,3,7,8-TCDD
and HCB may occur from the use of DCPA pesticide products
on various vegetable crops. Tolerances for DCPA do not in-
clude allowable residues for these impurities. Because
there are no actual crop residue data for these impurities,
estimates of potential dietary exposures to them from
DCPA use were calculated using DCPA tolerance levels.
The Agency is requiring analyses for residues of 2,3,7,8-
TCDD and HCB in or on agricultural commodities derived
from crops treated with DCPA pesticide products.
In estimating dietary exposures, it was also assumed that
the impurities are present in crop residues in the same
proportion to DCPA as the impurities are found in the
technical DCPA (i.e., 0.1 ppb 2,3,7,8-TCDD and 0.3% HCB).
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Based upon data on the percent of sites treated with DCPA
and the average residue contribution (ARC), the potential
dietary oncogenic risks were calculated using the equation:
Risk = Exposure x Q*
2,3,7,8-TCDD
Risk = 8 x 10-1* mg/kg/day x 1.6 x 105 (mg/kg/day)-1
= 1 x 10-8
HCB
Risk = 9 x 10~7 mg/kg/day x 1.7 (mg/kg/day)"1
= 2 x 10-6
d. Risks from Non-dietary Exposure
Potential non-dietary exposures to 2,3,7,8-TCDD and HCB
may result from applications of DCPA pesticide products
in commercial vegetable production and to turf and home
lawns. In calculating the potential exposures to these
impurities from these uses, several assumptions were
made. It was assumed that the impurities are present at
the maximum levels found in the technical DCPA product.
Estimated levels were then calculated based on estimated
DCPA exposures. Actual exposure monitoring data were
not available for DCPA; therefore, potential exposures
were estimated based on surrogate data using maximum
application rates. Exposure is expected to occur primarily
via the dermal and oral routes. Data indicate that a
dermal absorption rate for 2,3,7,8-TCDD may be less than
10%. However, in the absence of conclusive data on dermal
absorption, a conservative rate of 50% was used. No
data are available on HCB dermal absorption. Therefore,
it was assumed to be 100% for the purpose of estimating
non-dietary risks.
Agricultural workers in commercial vegetable production
are likely to use a wettable powder formulation of DCPA
twice a year (for a total of approximately 44 hours per
year). Based on surrogate exposure data, potential
cancer risks were calculated for dermal exposures to
2,3,7,8-TCDD and HCB from DCPA during mixing/loading
operations and application using ground boom equipment.
The potential risks were estimated to be 1 x 10-6 for
2,3,7,8-TCDD and 5 x 10~4 for HCB. The use of chemical
resistant gloves will reduce exposures, and therefore
potential risks, by approximately one order of magnitude.
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Pest control operators (PCOs) and homeowners may be exposed
to 2,3,7,8-TCDD and HCB during application of DCPA pes-
ticide products to turf and home lawns. Children playing
on treated lawns may also be exposed. The risk of adverse
effects from these exposures are difficult to estimate
because of the lack of information on foliar residues
and on the rate of dissipation from the foliage. The
Agency is requiring that certain exposure data be submitted
in order to estimate dermal and oral exposures to children
playing on treated lawns.
For PCOs, the potential cancer risks were estimated for
dermal exposures to 2,3,7,8-TCDD and HCB from applying
wettable powder formulations of DCPA with hose-end sprayers.
It was assumed that lawns are treated twice a year and
that PCOs mix, load, and apply DCPA an average of approxi-
mately 10 days per year. Based on surrogate exposure
monitoring data, the estimated cancer risks are 1 x 10~6
for 2,3,7,8-TCDD and 6 x 10~4 for HCB. The use of
chemical resistant gloves and clothing such as long pants
and long-sleeved shirts will reduce exposures and the
potential risks by approximately one order of magnitude.
Potential cancer risks to homeowners from dermal exposure
to 2,3,7,8-TCDD and HCB during application of granular
formulations of DCPA with a rotary spreader were calculated
using surrogate exposure data. Based on the assumption
that such an application takes approximately 2 hours, the
potential cancer risks from 2 applications per year were
estimated to be 3 x 10"8 for 2,3,7,8-TCDD and 2 x 10~5
for HCB. These risks will be reduced by approximately one
order of magnitude if long-sleeved shirt, pants and
chemical resistant gloves are worn during application.
Children playing on treated lawns may be exposed dermally
by direct contact to the toxic impurities in DCPA pesticide
products and orally by licking hands and fingers or exposed
toys. However, exposures to children playing on lawns that
have been treated with DCPA granules are expected to be
primarily from ingesting the granules. Quantitative
analysis of these potential exposures and potential risks
is difficult due to a general lack of information on
exposures to treated lawns and a lack of specific data
from foliar dissipation and dislodgeable residue studies
for DCPA and the impurities of concern. The Agency is
requiring data needed for estimating such exposures.
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In the absence of any data on exposures to DCPA and its
impurities from contact with treated turf, an analysis
was done based on assumptions. For wettable powder formu-
lations, a worst case assumption is that 100% of the
applied DCPA (and therefore 100% of the 2,3,7,8-TCDD and
HCB residue) remains on the foliage; that is, none of
these impurities reach the soil.
If it is further assumed that 2 days per year over a 10
year period a child's entire body comes in contact with
these impurities and that a child licks the surface of a
a 3" ball, the potential cancer risks are estimated to be
3 x 10~7 for 2,3,7,8-TCDD and 2 x 10~4 for HCB. The estim-
ated cancer risk from ingesting two granules of DCPA per
year for 10 years is 5 x 10~10 for 2,3,7,8-TCDD and 2
x 10~7 for HCB. The level of uncertainty in these
estimates is great.
The Agency estimated the margin of safety (MOS) for pro-
fessional and home applicators of DCPA using the NOELs
from 3- and 4-generation reproductive studies of 2,3,7,8-
TCDD and HCB, respectively. Although these are studies
of chronic exposures and may not be the most appropriate
basis for calculating MOSs for short term exposures to
2,3,7,8-TCDD and HCB from use of DCPA, they represent a
worst case. For 2,3,7,8-TCDD the MOSs ranged from approxi-
mately 2,000 for PCOs to greater than 6,000 for homeowners.
For HCB, the MOSs ranged from greater than 60 for profess-
ionals and 200 for homeowners.
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C. OTHER SCIENCE FINDINGS
1. iinvironmental Fate. Environmental fate data are limited to
one hydrolysis study and one mobility study. Data from the
hydrolysis study indicated that DCPA is stable to hydrolysis
in aqueous buffered sterile solutions adjusted to pH 5, 7 and
9 during 36 days of storage in the dark at 24 to 27 °C. Of
the added DCPA (14C) 98.9 percent remained undegraded at the
end of 36 days of storage.
Data from the mobility (leaching and absorption/desorption
study) indicated that DCPA (14C) was immobile in four silt
loam and one silty clay loam soils, based on soil thin layer
chromatography tests. Irradiated DCPA (14C) residues ranged
from immobile to mobile in the same five soils. Monomethyl-
tetrachloroterephthalate (MTP) and tetachlorotetraphthalic
acid (TPA) were identified as degradates in the irradiated
soil. This study does not fulfill data requirements for
mobility of DCPA as it did not completely describe the
analytical methods used, the moisture content of the soil was
not maintained at 75% of 0.33 bar during aging, the soil was
not adequately characterized, and distribution curves of DCPA
and its degradates throughtout the soil columns were not deter-
mined. Another study must be submitted to fulfill this
data requirement.
Hexachlorobenzene (HCB) is resistant to hydrolysis, photolysis
and biodegradation. Being soluble in lipophilic materials, it
is expected to be absorbed and to bioaccumulate in plants.
however, it is not expected to biomagnify through aquatic
food chains. The major source of HCB in aqueous organisms is
from aqueous rather than dietary sources. Rates of depuration
of HCB from exposed aquatic organisms are substantially more
rapid than rates of depuration reported for such highly persis-
tant compounds as DDT. Therefore, biomagnification of HCB
through aquatic food chains probably does not occur. The
Agency does not have adequate data to show that HCB is absorbed
from soils or that it bioaccumulates in plant tissues.
2,3,7,8-TCDD is resistant to hydrolysis, photolysis and bio-
degration. An apparent half-life for 2,3,7,8-TCDD in soil is
10 to 12 years. Because of its high affinity towards soils,
particularly those with significant organic content, and because
of its extremely low water solubilities, 2,3,7,8-TCDD tends to
remain in or near the surface of soils. With time, 2,3,7,8-TCDD
bound to soil becomes more difficult to desorb. Limited data
show that 2,3,7,8-TCDD is not likely to concentrate in plants
grown in contaminated soil. 2,3,7,8-TCDD will bioaccumulate in
aquatic organisms.
15
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2. Fcoloqical Effects. Formulated DCPA products are slightly to
practically nontoxic to finfish. They are practically nontoxic
to aquatic invertebrates. Formulations of DCPA are moderately
to practically nontoxic to aquatic invertebrates. Technical
grade DCPA had an LCso of 620 ug/L in eastern oysters, which
is highly toxic. There are adequate data to suggest there is no
acute hazard to endangered aquatic species. No terrestrial
endangered plants have been identified with any of the
use-patterns of DCPA products.
3. Ground Water. A ground water data call-in (DCI) notice was
issued for DCPA in July, 1984. Based on the data received
from that DCI, the Agency is requiring further ground water
monitoring to determine the extent of ground water contamination
with DCPA.
DCPA metabolites have been detected in ground water in New York
at 50 to 700 ppb. In Suffolk County, New York, 166 wells were
tested for DCPA and DCPA degradates. There were 25 detections
of DCPA acid degradates. The maximum concentration was 1039 ppb.
In a Cape Cod golf course study, three detections of DCPA acid
degradates were made. The concentration ranged from 0 to 0.35
ppb; the mean value was equal to 0.26 ppb. In California, DCPA
was detected four times in 1984 at a maximum concentration of
35 ppb in ground water. In Wisconsin, DCPA acid degradates
were detected in ground water in Dunn and Wankesha Counties at
a mean value of 254.66 ppb.
In November, 1987, the Agency proposed a lifetime health
advisory level for DCPA of 3500 ppb in drinking water. DCPA
and it degradates, which are considered to be toxicologically
equivalent to the parent compund, have been found to date in
ground water at levels below 1500 ppb. However, because of
the low number of observations, no conclusions can be
drawn about the significance of these findings.
Because HCB and 2,3,7,8-TCDD occur in such low quantities in
DCPA, the presence of these impurities in DCPA are not of
ground water concern. Furthermore, these impurities are
considered to be persistent, but non-mobile and are therefore
not expected to move into ground water.
16
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D. TOLERANCE REASSESSMENT
Tolerances have been established for residues of DCPA in or on
the raw agricultural commodities listed in Table 1. Tolerances
for DCPA are presently expressed as the herbicide dimethyl tetra-
chloroterephthalate and its metabolites monomethyl tetrachloro-
terephthalate (MTP) and tetrachloroterephthalic acid (TPA)
(calculated as dimethyl tetrachloroterephthalate). The metabolism
of DCPA in plants is not adequately understood. Metabolism studies
in lettuce/ turnip and onion plants exposed to the maximum quantity
permitted under existing registered labeling must be conducted to
resolve this data gap.
There are no established tolerances for DCPA residues in animal
fat, meat, and meat by-products, or in eggs or milk. The available
studies on the metabolism of DCPA in ruminants did not investigate
the nature of 14C residues found in tissues or milk. Nonradio-
labeled studies have detected the metabolites MTP and TPA in
ruminants and poultry. Therefore, studies are required with
ruminants and poultry using ring-labeled (14C) DCPA at a level
sufficient to make residue identification and quantification
possible. Milk and eggs must be collected twice daily during the
dosing period. Animals must be sacrificed within 24 hours of the
final dosing. The distribution and identity of the residues must
be determined in milk, liver, kidney, muscle and fat.
Samples from the studies requested above should also be
analyzed using current enforcement methods to ascertain the
validity of these methods for analysis of animal commodities.
Upon receipt of the requested data, the need for and nature
of tolerances for DCPA residues in animals products will be
determined.
Adequate gas-liquid chromatography (GLC) methods utilizing
either electron capture (EC) or microcoulometric (MC) detection
are available for collection of data pertaining to residues of
DCPA and its metabolites MTP and TPA in or on plant commodities.
The GLC/MC method described in MRID 00114642 is listed in PAM Vol.
II as Method B. The GLC/EC and GLC/MC methods must undergo method
validations to demonstrate their adequacy for tolerance enforcement
purposes. A colorimetric method is adequate for collection of
residue data for DCPA but does not determine MTP and TPA residues.
Colorimetric methods are not adequate for tolerance enforcement.
At the present time, no tolerances exist for residues of DCPA
and its metabolites MTP and TPA (calculated as DCPA) in animal
commodities, although registered uses exist on crops which may
result in residues in or on feed items. Adequate GLC analytical
methods that determine separate and combined residues of DCPA,
MTP, and TPA residues in animal commodities are available.
A method validation must be conducted to demonstrate method
residues in animal commodities proposed as a result of data
requirements.
17
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Table 1. Tolerances in parts per million (ppm) for residues of
DCPA and metabolites MTP and TPA.
Residues of DCPA Parts per Million
Raw Agricultural Commodity U.S. Canada Mexico Codex
Beans, field dry
Beans, mung, dry
Beans, snap, succulent
Broccoli
Brussels sprouts
Cabbage
Cantaloupes
Cauliflower
Collards
corn, field, fodder
corn, field, forage
Corn, grain (including
field and pop)
corn, pop, fodder
Corn, pop, forage
Corn, sweet (K + CWHR)
Corn, sweet, fodder
Corn, sveet, forage
Cottonseed
Cress, upland
Cucumbers
Eggplant
Garlic
Honeydew melons
Horseradish
Kale
Lettuce
Mustard, greens
Onions
Peas, southern, black-eyed
Peppers
Pimentos
Potatoes
Radish, roots
Radish, tops
Rutabagas
Soybeans
Squash, summer
Squash, winter
Strawberries
Sweet potatoes
Tomatoes
Turnips
Turnips, greens
Watermelons
Yams
2
2
2
1
1
1
1
1
2
0.4
0.4
0.05
0.4
0.4
0.05
0.4
0.4
0.02
5
1
1
1
1
2
2
2
5
1
2
2
2
2
2.0
15.0
2
2
1
1
2
2
1
2
5
1
2
_
—
—
-
-
—
—
—
-
-
-
-
-
-
-
-
-
-
-
_
-
—
—
—
_
_
—
—
-
-
—
_
-
-
-
-
-
-
-
-
-
-
—
—
-
18
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DCPA and its metabolite MTP have been subjected to one or
more multiresidue protocols in PAM Vol. 1. However, there are no
multiresidue procedures for TPA. The Residue Chemistry Data
Requirements in 40 CFR 158.125(a) require that regulated pesticides
be subjected to one or more of the multiresidue procedures published
in an Addendum to Pesticide Assessment Guidelines Subdivision
0-Residue Chemistry Data Requirements for Analytical Methods in 40
CFR 158.125, Multiresidue Protocols. Such testing has not been
conducted on TPA.
The storage stability data available are inadequate to support
the broad range of agricultural commodities with established
tolerances. Information on the duration and conditions of sample
storage prior to residue analysis and on the stability of DCPA
under the storage conditions used must be submitted to support
established tolerances.
bata gaps exist for each of the raw agricultural commodities
listed in the following table. Of particular concern is the lack
of data on the potential metabolites, the potential for residues
of DCPA to exist in processed commodities derived from these raw
agricultural commodities, and the potential for residues in fat,
meat, meat by-products, milk, and eggs of domestic animals. The
data requirements to support established tolerances as listed in
40 CFR 180.185 are given in Table A, Appendix I.
The Agency is also requiring data to show the nature of the
residues of DCPA impurites and the magnitude of these residues
on representative agricultural commodities. These data requirements
are described in Table A, Appendix I.
There are no food or feed additive regualations for DCPA
established under Section 409 of the Federal Food, Drug and
Cosmetic Act.
There are no direct animal treatments for DCPA on livestock or
poultry. At the present time, it is not possible to calculate the
maximum expected intake of DCPA residues by dairy cattle, beef
cattle, poultry, or swine.
Many livestock feed items derived from plants grown in DCPA
treated soils have no established tolerances or they have
tolerances that are inadequately supported by available residue
chemistry data. If the required animal metabolism data demonstrate
that detectable residues of concern may occur in animals from
registered uses, then data quantifying the magnitude of the residue
in animals will be required. Specific data requirements will be
detailed at that time.
19
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For the U.S. population, the Theoretical Maximum Residue
Contribution (TMRC) from established tolerances is 0.394 mg/day
(equivalent to an exposure of 0.006574 mg/kg/day for a 60 kg person),
based on a 1.5 kg diet and a 60 kg person. Based on a chronic
toxicity study in rats, the Provisional Acceptable Daily Intake
(PADI) was established at 0.5 mg/kg/day, based on the NOEL of 50
mg/kg/day and a 100 fold uncertainty factor to account for data
gaps and extrapolation from animal data to humans. The Maximum
Permissible Intake (MPI) for a 60 kg person is, therefore, 30.0
mg/day. Using this value, existing tolerances utilize 1.3% of the
PADI. The TMRC is a conservative estimate because it does not
consider the effect of processing on residue levels in the raw
agricultural commodities, that actual residue levels may be lower
than the established tolerances, and that less than 100 percent
of the crop is treated. Available FDA monitoring data for DCPA
indicate that actual residues are less than tolerance levels.
Vhe PADI used in this assessment was based on a rat feeding
study that indicated a 0.5 mg/kg/day NOEL based on effects on
kidney weights in males and adrenal weights in females. A PADI
was established rather than an ADI because the study was not
acceptable under present EPA Guidelines. Data required under
this Standard will likely change this assessment.
For the U.S. population of children from 1 to 6 years of age
the TMRC from established tolerances is equivalent to an exposure
of 0.011749 mg/kg/day based on the EPA Tolerance Assessment System.
This is the greatest exposed segment of the US population as
determined under the EPA Tolerance Assessment System.
The Federal Food and Drug Administration's (FDA) tolerance
monitoring "Total Diet Study Market Basket", over a period between
April 1982 and April 1986, found no residues of DCPA exceeding
established tolerances in any food item. DCPA residues occurred
in the following food items for which no tolerances exist: raw
apples (0.0004 - 0.004 ppm), chili con carne with beef (0.002 -
0.004 ppm), pear/pears with pineapple (0.002 ppm), canned spinach
(0.0008 - 0.001 ppm), boiled spinach (0.0003 - 0.004 ppm), fried
breaded shrimp (0.002 ppm) and tuna canned in oil (0.002 ppm).
During the period of 1978 to 1987, the FDA reported finding
only two samples of imported lettuce that exceeded the U.S.
established tolerance for residues of DCPA in or on lettuce.
20
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IV. REGULATORY ASSESSMENT
A. REGULATORY POSITIONS AND RATIONALES
Based on review and evaluation of all available data on DCPA,
the Agency has made the following determinations:
1. Special Review
The Agency will not place DCPA into Special Review at this
time.
Rationale; There are presently no chronic toxicological
concerns for exposures to DCPA and there are insufficient data
to indicate unreasonable hazard to wildlife or endangered species.
However, the Agency's evaluation OF DCPA has raised concerns
about the chronic toxicological effects of two manufacturing
impurities, 2,3,7,8-TCDD and HCB, which cannot be resolved by the
available information. The Agency performed a preliminary risk
assessment based on the assumption that the impurities, HCB and
2,3,7,8-TCDD are found in DCPA residues in the same proportion
as they are found in the technical product. Exposures to HCB
and 2,3,7,8-TCDD were calculated to constitute 0.3 percent and
0.1 parts per billion, respectively, of the estimated exposure to
DCPA. The results of this risk assessment are presented in
Section III (Agency Assessment) of this Standard.
The uncertainties of this risk assessment are very great.
Therefore, the Agency is requiring that the registrant develop
additional exposure data for the impurities. In order to assess
the potential risk from dioxin contamination, additional data
are needed to determine whether DCPA is contaminated by other
species of chlorinated dibenzo-p-dioxins or furans. These data
were requested in a data call-in Notice issued in June, 1987.
When the information on the presence of any additional dibenzo-
-p-dioxins or dibenzofurans is available, the Agency will
reevaluate the risk from the use of DCPA products. However, at
the present time the risk due to 2,3,7,8-TCDD from the use of
DCPA is not considered to be unreasonable. The highest risk
estimated was 10~6 for agricultural applicators and PCO's.
The risks due to HCB from the use of DCPA are 10~* for
agricultural applicators and PCOs. While these levels are of
concern, the Agency believes that the risk to applicators can be
reduced to acceptable levels by using protective clothing.
The Agency's preliminary risk assessment also showed that
the risks due to HCB from the use of DCPA to treat lawns could
be as high as 10~* for children exposed while playing on treated
lawns. The Agency believes however that the uncertainties in
the exposure assessment for HCB are so great that the preliminary
risk assessment cannot be used as a basis for determining whether
21
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criteria for initiating a Special Review have been exceeded.
The risk calculated for a child is assumed to be the worst-case
and probably is greatly over-estimated. In making the exposure
estimates, the Agency made assumptions about the frequency of
exposure, the amount of HCB that is present, the rate of HCB
absorption through various routes, and the occurrence of behaviors
(such as eating DCPA granules, eating foliage or soil that has
been treated with DCPA, or licking toys that have come into
contact with DCPA-treated foliage or soil) which could result in
exposures much higher than would occur through the dermal route.
In order to develop a better assessment of exposure, the Agency
is requiring dislodgeable residue and foliar dissipation data on
HCB. When this information becomes available, the Agency will
reconsider its decision on initiating a Special Review on DCPA.
The Agency's preliminary assessment of HCB risk showed that
dietary exposure to HCB present as an impurity in DCPA resulted
in a risk of 2 x 10 ~6- The Agency believes this risk to be
acceptable during the period in which additional data are developed.
The Agency is requiring the submission of metabolism and residue
data on this impurity to resolve the issue of dietary exposure.
2. Restricted Use
The Agency is not classifying any DCPA products or uses as
being for restricted use.
Rationale: As discussed above, the uncertainties in the
exposure assessments for HCB are very great. Accordingly, the
Agency is unable to conclude that the risk posed by HCB warrants
action to classify DCPA as a restricted use pesticide. Data
needed to quantify the risks of HCB and other contaminants are
identified in this Standard. When these data become available,
the Agency will reconsider its position on the classification
of DCPA.
As discussed below, the Agency is imposing requirements
for protective clothing and reentry intervals which it believes
will reduce exposure to the contaminants of concern for applicators
and other persons who may be at risk.
3. Certification, of Limits of Impurities
The Agency is requiring DCPA registrants to certify that
technical DCPA used in formulating their end-use products does
not contain 2,3,7,8-TCDD and HCB in excess of 0.1 ppb and 0.3
percent, respectively. In addition, the Agency is requiring
establishment of certified limits for any other tetra-
through hepta- chlorinated dibenzo-p-dioxin or dibenzofuran that
may be present in technical DCPA.
22
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Rationale. The Agency is aware that 2,3,7,8-TCDD and HCB
are formed during the manufacture of DCPA. The Agency has based
its decision not to initiate Special Review or to restrict the
use of DCPA on the belief that the contaminant levels in technical
DCPA that is used to prepare commercial products do not exceed
the reported maximum levels. If the levels of the impurities
are higher than specified above, the risks posed by these
impurities would be correspondingly higher. The Agency therefore
concludes that establishment of certified limits for these
impurities is necessary to minimize the risk posed by these
substances.
The Agency has already required registrants to establish
certified limits for certain species of chlorinated dibenzo-p-
dioxins and dibenzofurans in the June, 1987 dioxin/furan data
call-in Notice.
4. Significant New Uses
The Agency will not register any significant new uses of
DCPA until product chemistry, toxicology and residue chemistry
data it is requiring in this Standard have been submitted
and found to be acceptable for assessing the proposed uses and
demonstrate that the proposed uses will not result in unreasonable
risks.
Rationale; The data gaps in these areas are such that
registrations of significant new uses of DCPA should await
submission and evaluation of the critical data required by this
Standard.
5. Ground Water
The Agency is requiring ground water monitoring studies on
DCPA and its degradates to determine the extent of ground water
contamination.
Rationale; DCPA and its degradates have been found in ground
water samples in four states. The Agency has proposed a lifetime
health advisory level for DCPA of 3500 ppb in drinking water.
DCPA and it degradates, which are considered to be toxicologically
equivalent to the parent compound, have been found to date in
ground water at levels below 1500 ppb. Because of the low
toxicity of the compound, the low levels observed to date and
the limited number of observations, the Agency does not feel
that regulatory action, other than retrospectove ground water
monitoring studies, is warranted.
23
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6. Protective Clothing
In order to meet the statutory standard for continued
registration, the Agency is requiring the use of certain minimum
protective clothing and equipment for end-use products. The
required labeling language is found in Section IV.D. of this
document.
Rationale: Based on the potential risk of chronic effects from
the impurities 2,3,7,8-TCDD and HCB in DCPA products, the Agency
finds these requirements necessary to protect the public. The
wearing of long-sleeved shirt, long-legged pants and chemically
resistant gloves and the washing of exposed skin and contam-
inated clothing as prescribed in the required labeling will reduce
exposure to DCPA products and decrease the risk of adverse effects.
7. Reentry Intervals
In order to meet the statutory standard for continued
registration, the Agency is requiring an interim 24-hour reentry
interval for agricultural crop uses of DCPA until required reentry
data have been submitted, evaluated, and found to support a
different reentry interval. The required labeling language is
found in Section IV.D. of this document.
Rationale; DCPA meets the toxicity criteria of 40 CFR 158.140
related to reentry restrictions because there is evidence which
indicates that its impurities 2,3,7,8-TCDD and HCB are oncogenic,
mutagenic, or cause developmental effects. DCPA also meets the
exposure criteria of 40 CFR 158.140 for requiring a reentry
period because it is registered for uses which could involve
substantial exposure of agricultural workers to residues of its
impurities 2,3,7,8-TCDD and HCB. Until data are submitted, as
required in Appendix I, which demonstrate that either a longer or
shorter reentry interval is appropriate for DCPA, the interim
24-hour reentry interval will serve to reduce post-application
exposure to 2,3,7,8-TCDD and HCB in DCPA products. (The Agency
imposes a 24-hr reentry level whenever it finds that reentry
retrictions are warranted, but lacks data to characterize the
residues present during the post-application period.)
8. Dietary Exposure Data on Impurities
The Agency is requiring the following studies on impurities
in DCPA to support registration of food uses of DCPA: product
chemistry, plant and animal metabolism, storage stability,
analytical methodology and the magnitude of residues in or on
representative raw agricultural commodities.
Rationale: Current estimates of dietary risk from DCPA
impurities are based on the assumption that the impurities are
present in DCPA residues on food in the same proportion as they
24
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occur in the pesticide product. Data are needed to determine
the nature and magnitude of 2,3,7,8-TCDD and HCB residues. If
the uata show that the impurities or their metabolites accumulate
in DCPA-treated agricultural commodities to levels that raise
concerns about dietary risk, the Agency may find that additional
regulatory action is warranted.
9. Environmental Fate Data on Impurities
The Agency is requiring dislodgeable residue and foliar dis-
sipation data on HCB in order to estimate dermal exposure to
this impurity.
Rationale; The Agency has based its preliminary risk assessment
of non-dietary risk from environmental HCB residues on the
assumption that HCB are present in DCPA residues on soil or
foliage in the same proportion as it occurs in the pesticide
product. Data are needed to determine the fate of soil and
foliar HCB residues in order to refine the estimates of HCB
exposure to farm workers and to users of lawns that have been
treated with DCPA.
10. Data^ Designated for Priority Review
The Agency has identified certain data requirements that
will receive priority review when received.
Rationale: Certain data are essential to the Agency's
assessment of this pesticide product and its uses and may trigger
the need for further studies that should be initiated as soon as
possible. The following studies have been identified for priority
review when received by the Agency:
158.120 Product Chemistry
61-2 Description of Beginning Materials and
Manufacturing Process
61-3 Discussion of Formation of Impurities
62-1 Preliminary Analysis
158.125 Residue Chemistry - DCPA
171-4 Nature of Residue (Metabolism)
-Plants
-Livestock
171-4 Residue Analytical Method
-Plant Residues
-Animal Residues
171-4 Storage Stability Data
158.125 Residue Chemistry -^Impurities
171-4 Nature of Residue (Metabolism)
25
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-Plants
-Livestock
171-4 Residue Analytical Method
-Plant Residues
-Animal Residues
171-4 Storage Stability Data
158.130 Environmental Fate
163-1 Leaching and Adsorption/Desorption
132-1 Foliar Dissipation
133-3 Dermal Exposure (Conditional, at option of Registrant)
133-4 Inhalation Exposure (Conditional, at option of
Registrant)
— Ground Water Monitoring
11. Currently^Registered Uses
While the data gaps are being filled, currently registered
MPs and EPs containing DCPA as an active ingredient may be sold,
distributed, formulated, and used, subject to the terms and
conditions described in this Standard. Registrants must provide
or agree to develop additional data, as specified in the Data
Appendices of this document, in order to maintain existing
registrations.
Rationale: Under FIFRA, the Agency may choose not to cancel
or withhold pesticide registration if data are missing or inadequate
(see FIFRA sections 3(c)(2)(B) and 3(c)(7)).
Issuance of this Registration Standard provides a mechanism
for identifying data needs. When these data are submitted, they
will be reviewed and evaluated, after which the Agency will deter-
mine if additional regulatory action is warranted.
26
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B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard, products
must contain DCPA as one of the active ingredients, bear required
labeling, and conform to the applicable composition, acute toxicity
limits, and use pattern requirements listed in this section.
C. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
To be registered or reregistered under this Standard, pro-
ducts must contain DCPA as one of the active ingredients. Each
MP product proposed for registration must be fully described
with an appropriate certification of limits, stating maximum and
minimum amounts of the active ingredient and inert ingredients
that are present in the product, as well as impurities found at
levels greater than 0.1 percent.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade
and manufacturing-use products containing DCPA provided that the
product labeling bears appropriate precautionary statements for
the acute toxicity category in which each product is placed.
3. Use Patterns
To be registered under this Standard, EPs may be labeled
only for the uses listed below. The Index lists all registered
uses, as well as approved application rates and frequencies.
- Terrestrial Food Crops;
Agricultural Food Crops: Beans (dry, field, snap),
broccoli, Brussels sprouts, cabbage, cantaloupe, cauliflower,
collards, corn (field), corn (sweet), cotton, cress (upland),
cucumber, eggplant, garlic, honeydew melon, horseradish, kale,
leeks, lettuce (head), lettuce (leaf), mung beans, mustard greens,
onions, peppers, potato (whole or cut pieces), Southern beans
(blackeyed peas), radish (grown for seed), soybeans, squash,
strawberry, sweet potatoes, tomato, turnip (greens), turnip
(roots), watermelon, yams (Ipomoea spp.).
Terrestrial Nonfood Crop;
Ornamental Plants and Ornamemtal Forest Trees:
abelia, African violet, ageratum, ajuga, alyssum, arborvitae,
ash, aster, athletic field turf, Austrian pine, azalea, baby's
breath, barberry, bellflower, birch, bleeding heart, bloodleaf,
blue bedder salvia, blue spruce, border forsythia, Boston ivy,
boxwood, bugloss, California privet, camellia, candle larkspur,
candy tuft, Cape marigold, chestnut, chrysanthemum, cinquefoil,
coleus, columbine, coneflower, coral bells, coreopsis, coton-
27
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easter, cottonwood, creeping juniper, creeping thyme, cuphea,
cypress, dahlias, daisies, deutzia, dogwood, dwarf forsythia,
elaeagnus, elm, English ivy, English ivy (ground cover), euonymus,
evening primrose, fernleaf, yarrow, feverfew, fir, flowering
crabapple, forget-me-not, forsythia, four-o-clock, foxglove,
gaillardia, geranium, gladiolus, gold dust, golden marguerite,
goldentuft, golf fairways/golf greens, ground-hemlock, gum,
hawthorn, heath, holly, honeysuckle, hybrid tea roses, hydrangea,
iris, ivy (ground cover), Japanese andromeda, Japanese barberry,
Japanese privet, Japanese yew, juniper, lantana, larkspur, lavender
cotton, liqustrum, lilac, lilies, loblolly pine, locust, lupines,
magnolia, maple, marigold, mentor barberry, mock-orange, morning-
glory, mountain-laurel, multiflora rose, nasturtium, oak, orpine,
pachysandra, pachysandra (ground cover), paxistima, peonies,
petunias, pine, pittosporum, ponderosa pine, poplar, podocarpus,
purple coneflower, red pine, redbud, rhododendron, rose, rose
moss, Russian olive, salvia, scabiosa, scarlet sage, Scotch pine,
shore pine, snapdragon, spiderwort, spirea, spruce, stonecrop,
strawflower, sundrops, sunflowers, sweet pea, sycamore, torch
lily, tree peony, tulip tree, variegated privet, verbena, violets,
wallflower, walnut, weigela, white spruce, willow, wormwood,
yarrow, yellow pine, yew and zinnia.
- Domestic Outdoor;
Ornamental plants and forest trees - Bermudagrass (from
sod), ornamental lawns, zoysia grass (from sod).
D. REQUIRED LABELING
In order to remain in complaince with FIFRA, manufacturing
and end-use products must bear appropriate labeling as specified
in 40 CFR 162.10 and PR Notices 83-2 and 83-3. Appendix II
contains information on label requirements.
No pesticide product containing DCPA may be released for
shipment by a registrant twelve months after receipt of this
Standard unless the product bears an amended label which complies
with the requirements of this Standard.
No pesticide product containing DCPA may be distributed,
sold, offered for sale, held for sale, shipped, delivered for
shipment, or received and (having been so received) delivered or
offered to be delivered by any person 24 months from the date
of receipt of this Standard unless the product bears an amended
label which complies with the requirements of this Standard.
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The following information must appear on the labeling of
DCPA products to remain in compliance with FIFRA:
1. Ingredient Statement
The ingredient statement for all products must identify
the active ingredient as:
Active Ingredient: By Wt.
DCPA (dimethyl tetrachloroterephthalate) .... %
Inert Ingredients: %
2. Precautionary Statements
All products must bear the following precautionary
statement:
Causes moderate eye irritation. Avoid
contact with eyes or clothing. Wash
thoroughly with soap and water after
handling.
3. Environmental Hazards Statements
a. Manufacturing Use Products
All MP labeling must bear the following environmental
hazard statement:
Do not discharge effluent containing
this product into lakes, streams, ponds,
estuaries, oceans, or public waters unless
this product is specifically identified and
addressed in an NPDES permit. Do not dis-
charge effluent containing this product to
sewer systems without previously notifying
the sewage treatment plant authority.
For guidance, contact your State Water
Board or Regional Office of the EPA.
b. End Use Products
1) All nongranular products must bear the following
environmental hazard statements:
Do not apply directly to water or
wetlands (swamps, bogs, marshes, and
potholes). Do not contaminate water
when disposing of equipment wastewater.
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2) All granular products must bear the following
environnental hazard statements:
Collect and incorporate granules
spilled on the soil surface. Do not
apply directly to water or wetlands
(swamps, bogs, marshes, and potholes).
Do not contaminate water by cleaning
of equipment or disposal of wastes.
4. Use Statements and Worker Protection
a. Manufacturing Use Products - None.
b. End Use Products - The following statements must be
included in the "Directions for Use" as specified:
1) All EPs labeled for Agricultural Uses and
Commercial Ornamental Plant Uses must bear the
following statements:
USE ONLY WHEN WEARING THE FOLLOWING PROTECTIVE
CLOTHING AND EQUIPMENT DURING MIXING/LOADING AND
APPLYING, REPAIR AND CLEANING OF MIXING, LOADING,
AND APPLICATION EQUIPMENT, DISPOSAL OF THE PESTICIDE,
AND EARLY REENTRY INTO TREATED AREAS: Wear a long-
sleeved shirt and long-legged pants and chemical
resistant gloves.
IMPORTANTl If pesticide comes in contact with skin,
wash off with soap and water. Always wash hands,
face, and arms with soap and water before smoking,
eating, drinking, or toileting.
AFTER WORK: Before removing gloves, wash them with
soap and water. Take off all work clothes and shoes.
Shower using soap and water. Do not reuse contaminated
clothing. Clothing worn during work must be laundered
separately from household articles. Clothing that
becomes heavily contaminated or drenched must be
destroyed according to State and local regulations.
HEAVILY CONTAMINATED OR DRENCHED CLOTHING CANNOT BE
ADEQUATELY DECONTAMINATED.
2) All EPs labeled for homeowner uses must bear the
following statements:
USE ONLY WHEN WEARING THE FOLLOWING PROTECTIVE
CLOTHING:
Wear long-sleeved shirt and long-legged pants and
chemical resistant gloves.
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IMPORTANTl If the pesticide comes in contact with
skin wash off with soap and water. Always wash
hands, face, and arms with soap and water before
smoking, eating, drinking, or toileting.
AFTER USE: Before removing gloves, wash them with
soap and water. Take off all work clothes and shoes.
Shower using soap and water. Do not reuse contam-
inated clothing. Clothing worn during use must be
laundered separately from household articles.
3) All EPs labeled for agricultural crop use must
bear the following statement:
Do not enter treated areas for 24 hours after
application unless wearing long sleeved shirt and
long pants.
5. Statements of, Practical Treatment
All products must bear the following statements of
practical treatment:
If in Eyes; Flush with plenty of water.
Call a physican if irritation persists.
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.A. are subject to certain requirements
for data submission or changes in composition, labeling or
packaging of the product. The applicable requirements depend
on whether the product is a manufacturing or end use product
and whether the pesticide is the sole active ingredient or
one of multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as
the sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and B2
3. The labeling requirements specified for manufacturing
use products in Section IV.
4. Administrative requirements (application forms, Confiden-
tial Statement of Formula, data compensation provisions)
associated with reregistration.
2 Data requirements are listed in the three Tables in
Appendix I of this Registration Standard. The Guide to
Tables in that Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to all
products containing the pesticide subject to this Registra-
tion Standard. Table B lists product-specific data applicable
to manufacturing use products. The data in Tables A and B
need not be submitted by a producer who is eligible for the
formulator's exemption for that active ingredient.
Table C lists product-specific data applicable to end use
products. The Agency has decided that, in most cases, it
will not require the submission of product-specific data for
end use products at this time. Therefore most Registration
Standards do not contain a Table C.
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B. Manufacturing use products containing this pesticide
as one of multiple active ingredients are subject to:
1. The data requirements listed in Table A.
2. The labeling requirements specified for manufacturing
use products in Section IV.
C. End use products containing this pesticide as the
sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to the
end use product.
2. If eligible for the formulator's exemption3, the
data requirements listed in Table C.
3. If not eligible for the formulator's exemption, the
data requirements listed in Table A and the data require-
ments listed in Table C.
4. The labeling requirements specified for end use
products in Section IV.
D. End use products containing this pesticide as one of
multiple active ingredients are subject to:
1. If not eligible for the formulator's exemption,
the data requirements listed in Tables A and C.
3 If you purchase from another producer and use as the
source of your active ingredient only EPA-registered products,
you are eligible for the formulator's exemption for generic
data concerning that active ingredient (Table A) and product-
specific data for the registered manufacturing use product
you purchase (Table B).
Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient,
or acquire your active ingredient from a firm with ownership
in common with yours, you individually lose the exemption
and become subject to the data requirements in Table A.
2) If no producer subject to the generic data requirements
in Table A agrees to submit the required data, all end use
producers lose the exemption, and become subject to those
data requirements.
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2- If eligible for the formulator's exemption, the
data requirements listed in Table C.
3. The labeling requirements specified for end use
products in Section IV.
VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice
issued under the authority of FIFRA sec. 3(c)(2)(B). It
refers to the data listed in Table A, which are required to
be submitted by registrants to maintain in effect the regis-
tration of products containing this active ingredient.4
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often required
for ecological effects studies and applies to all products
having that formulation type. These are classed as generic
data, and are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the forraulator's
exemption (FIFRA sec. 3(c)(2)(D) and S 152.85) to submit
generic data in response to a DCI notice if the registrant
who supplies the active ingredient in his product is complying
with the data request.
If you are granted a generic data exemption, you rely on
the efforts of other persons to provide the Agency with the
required data. If the registrants who have committed to
generate and submit the required data fail to take appropriate
steps to meet the requirements or are no longer in compliance
with this data requirements notice, the Agency will consider
4 Registrations granted after issuance of this Standard will
be conditioned upon submission or citation of the data listed
in this Registration Standard.
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that both they and you are not In compliance and will normally
initiate proceedings to suspend the registrations of both
your product(s) and their product(s) unless you commit to submit
and submit the required data in the specified timeframe. In
such cases, the Agency generally will not grant a time extension
for submitting the data.
If you are not now eligible for a formulator's exemption,
you may qualify for one if you change your source of supply
to a registered source that does not share ownership in
common with your firm. If you choose to change sources of
supply, the Confidential Statement of Formula must identify
the new source(s) and you must submit a Formulator's Exemption
Statement form.
If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
Standard, you will be required to submit or cite generic
data relevant to the uses of your product if, at the time
the application is submitted, the data have been submitted
to the Agency by current registrants. If the required data
have not yet been submitted, any new registration will be
conditioned upon the new registrant's submission or citation
of the required data not later than the date upon which
current registrants of similar products are required to provide
such data. See FIFRA sec. 3(c)(7)(A). If you thereafter fail
to comply with the condition of that registration to provide
data, the registration may be cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed
to evaluate current uses of all products containing this
active ingredient, the uses for which such data are required,
and the dates by which the data must be submitted to the
Agency.
D. How to comply with PCI requirements.
Within 90 days of your receipt of this Registration
Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1, enclosed) for each of your products. On that form
you must state which of the following six methods you will
use to comply with the DC! requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost o?
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
submit the data on which you will rely. You must also provide
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EPA with documentary evidence that an agreement has been
formed which allows you to rely upon the data to be submitted.
Such evidence may be: (1) your letter offering to join in
an agreement and the other registrant's acceptance of your
offer, (2) a written statement by the parties that an agreement
exists, or (3) a written statement by the person who will be
submitting the data that you may rely upon its submission.
The Agency will also require adequate assurance that the
person whom you state will provide the data is taking appropriate
steps to secure it. The agreement to produce the data need
not specify all of the terms of the final arrangement between
the parties or a mechanism to resolve the terms.
If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data
Submitter Number from the Registration Support and Emergency
Response Branch, Registration Division. The request must
include the following information:
a. A list of the members of the consortium;
b. The name and address of the designated representative
of the consortium, with whom EPA will correspond
concerning the data;
c. Identity of the Registration Standard containing
the data requirement;
d. A list of the products affected (from all members
of the consortium); and
e. Identification of the specific data that the con-
sortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submissions by the consortium.
3. You have attempted to enter into an agreement to
jointly develop data, but no other registrant has accepted
your offer. You request that EPA not suspend your registration
for non-compliance with the DCI.EPA has determined that,
as a general policy,it will not suspend the registration of
a product when the registrant has in good faith sought and
continues to seek to enter into a data development/cost
sharing program, but the other registrants developing the
data have refused to accept its offer. [If your offer is
accepted, you may qualify for Option 2 above by entering
into an agreement to supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification of Attempt
to Enter into an Agreement with other Registrants for Develop-
ment of Data" (EPA Form 8580-6. enclosed).
2. Provide us with a copy of your offer to the other
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registrant and proof of the other registrant's receipt of your
offer (such as a certified nail receipt). Your offer must,
at a minimum, contain the following language or its equivalent:
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(B) in the [name of active ingredient] Registration
Standard upon terms to be agreed or failing agreement
to be bound by binding arbitration as provided by FIFRA
section 3(c)(2)(B)(iii).
The remainder of your offer may not in any way attempt to
limit this commitment. If the other registrant to whom your
offer is made does not accept your offer, and if the other
registrant informs us on a DCI Summary Sheet that he will
develop and submit the data required under the DCI, then you
may qualify for this option. In order for you to avoid
suspension under this method, you may not later withdraw or
limit your offer to share in the burden of developing the
data.
In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice in a timely manner. If the other registrant fails to
develop the data or for some other reason would be subject to
suspension, your registration as well as that of the other
registrant will normally be subject to initiation of suspension
proceedings, unless you commit to submit and submit the required
data in the specified timefrarae. In such cases, the Agency
generally will not grant a time extension for submitting the data.
4. You request a waiver of the data requirement. If
you believe that a data requirement does not (or should not)
apply to your product or its uses, you must provide EPA with
a statement of the reasons why you believe this is so. Your
statement must address the specific composition or use factors
that lead you to believe that a requirement does not apply.
Since the Agency has carefully considered the composition and
uses of pesticide products in determining that a data require-
ment applies, EPA does not anticipate that many waivers will
be granted. A request for waiver does not extend the time-
frames for developing required data, and if your waiver
request is denied, your registration may be suspended if you
fail to submit the data.
5. You request that EPA amend your registration by deleting
the uses for which~~the data are needed. You are not required
to submit data for uses which are no longer on your label.
6. You request voluntary cancellation of the registration
of your product(s) for which the data are needed.
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E« Testing Protocols. Standards for Conducting Acceptable
Tests, Guidance on Evaluating and Reporting Data.
All studies required under this Notice must be conducted
in accordance with test standards outlined in the Pesticide
Assessment Guidelines, unless other protocol or standards are
approved for use by the Agency in writing.
As noted herein, these EPA Guidelines, which are referenced
in the Data Tables, are available from the National Technical
Information Service (NTIS), Attn: Order Desk, 5285 Port Royal
Road, Springfield, VA 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if
the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (Part 158.70).
Please note, however, that certain OECD standards (such as
test duration, selection of test species, and degradate
identification which are environmental fate requirements) are
less restrictive than those in the EPA Assessment Guidelines
listed above. When using the OECD protocols, they should be
be modified as appropriate so that the data generated by the
study will satisfy the requirements of Part 158. Normally,
the Agency will not extend deadlines for complying with data
requirements when the studies were not conducted in accord
with acceptable standards. The OECD protocols are available
from OECD, 1750 Pennsylvania Avenue, N.W. , Washington, D.C.
20006.
F. Procedures for requesting a change in testing protocol.
If you will generate the required data and plan to use
test procedures which deviate from EPA's Pesticide Assessment
Guidelines or the Reports of Expert Groups to the Chemicals
Group, Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must submit for EPA
approval the protocols you propose to use.
You should submit your protocols before beginning testing,
because the Agency will not ordinarily accept as sufficient
studies using unapproved protocols. A request for protocol
approval will not extend the timeframe for submission of the
data, nor will extensions generally be given to conduct
studies due to submittal of inappropriate protocols.
G. Procedures for requesting extensions of time.
If you think that you will need more time to generate
the data than is allowed by EPA's schedule, you may submit a
request for an extension of time. Any request for a time
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extension which is made as an initial response to a section
3(c)(2)(B) request notice must be submitted in writing to
the Product Manager listed at the end of this section and
must be made by the 90-day deadline for response. Once
dates have been committed to and EPA has accepted these
commitments, any subsequent requests for a time extension
must be submitted in writing to the Office of Compliance
Monitoring at the address given in Section IX.E.
EPA will view failure to request an extension before
the data submission response deadline as a waiver of any
future claim that there was insufficient time to submit the
data. While EPA considers your request, you must strive to
meet the deadline for submitting the data.
The extension request should state the reasons why you
believe that an extension is necessary and the steps you
have taken to meet the testing deadline. Time extensions
normally will not be granted due to problems with laboratory
capacity or adequacy of funding, since the Agency believes
that with proper planning these can be overcome.
A request for an extension does not extend the timeframe
for submission of the data. If EPA denies your request for
a time extension and you do not submit the data as requested,
EPA may begin proceedings to suspend the registrations of
your products.
H. PR Notice 86-5 and Any Other Requirements Referenced or
Included Within this Notice.
All data submitted in response to this Notice must comply
with EPA requirements regarding the reporting of data,
including the manner of reporting, the completeness of results,
and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or
included in this Notice or contained in PR Notice 86-5 (issued
July 29, 1986).
I. Existing stocks provision upon suspension or cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under
FIFRA sec. 3(c)(2)(B), an existing stocks provision is not
consistent with the Act. Accordingly, the Agency does not
anticipate granting permission to sell or distribute existing
stocks of suspended product except in rare circumstances.
If you believe that your product will be suspended or cancelled
and that an existing stocks provision should be granted, you
have the burden of clearly demonstrating to EPA that granting
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such permission would be consistent with the Act. The following
information must be included in any request for an existing
stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of
existing stocks and your estimate of the time required
for their sale or distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of FIFRA.
VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing
using a specific formulated product, and, unlike generic
data, generally support only the registration of that product.
All such data must be submitted by the dates specified in
this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data
are listed in Table C. As noted earlier, the Agency has
decided that it will not routinely require product-specific
data for end use products at this time. Therefore, Table C
may not be contained in this Registration Standard; if there
is no Table C, you are not required to submit the data at
this time.
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section VI.D, E, F, and G. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options VI.D.I. (submit data)
or VI.D.6.(cancellation of registration).
Failure to comply with the product-specific data require-
ments for your products will result in suspension of the
product's registration.
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VIII. REQUIREMENT FOR SUBMISSION OF REVISED LABELING
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the Agency's assessment of the data supporting the product
and its uses. General labeling requirements are set out in
40 CFR 162.10 (see Appendix II - LABELING and SUMMARY). In
addition, labeling requirements specific to products containing
this pesticide are specified in Section IV.D of this Registra-
tion Standard. Applications submitted in response to this
notice must include draft labeling for Agency review.
If you fail to submit revised labeling as required,
which complies with 40 CFR 162.10 and the specific instructions
in Section IV.D., EPA may seek to cancel or suspend the
registration of your product under FIFRA sec. 6.
IX. INSTRUCTIONS FOR SUBMISSION
A. Manufacturing Use Products (MUPs) containing the subject
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
for each product subject to this Registration Standard:
a. The "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA
Form 8580-1), with appropriate attachments.5
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
d. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(1)(D). Refer to 40 CFR
152.80-152.99.
5 If on the Summary Sheet, you commit to develop the data,
present arguments that a data requirement is not applicable
or should be waived, or submit protocols or modified protocols
for Agency review, you must submit a copy of the Summary
Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data
generated in response to this notice. This submission is in
addition to responding to the Product Manager, and should be
submitted to the Office of Compliance Monitoring at the
address given at the end of this section. (Actual studies
are not to be submitted to the Office of Compliance Monitoring.)
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2. Within 12 months after receipt of this document you
must submit to the Product Manager:
a. Application for Pesticide Registration (EPA
Form 8570-1).
b. Two copies of any required product-specific data
(See Table B).
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
Labeling should be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for
storage in 8-1/2 x 11 files. The draft label must indicate
the intended colors of the final label, clear indication
of the front panel of the label, and the intended type
sizes of the text.
d. Product Specific Data Report (EPA Form 8580-4).
3. Within the times set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
B. Manufacturing Use Products containing the subject pesticide
in combination with other active ingredients.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA sec. 3(c)(2)(B) Summary Sheet, with appropriate
attachmentsS (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
2. Within 12 months afrer receipt of this document, you must
submit to the Product Manager:
Three copies of draft labeling, including the container
label and any associated supplemental labeling. Labeling
should be either typewritten text on 8-1/2 x 11 inch
paper or a mockup of the labeling suitable for storage
in 8-1/2 x 11 files. The draft label must indicate the
intended colors of the final label, clear indication of
the front panel of the label, and the intended type
sizes of the text.
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3. Within the time frames set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the fonnulator1s exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
C. End Use Products containing the subject 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:
a. FIFRA Section 3(c)(2)(B) Summary Sheet, with
appropriate attachments* (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
2. Within 12 months after receipt of this document you
must submit to the Product Manager:
a. Two copies of any product-specific data, if required
by Table C.
b. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
Labeling should be either typewritten text on 8-1/2 x 11
inch paper or a raockup of the labeling suitable for
storage in 8-1/2 x 11 files. The draft labeling must
indicate the intended colors of the final label, clear
indication of the front panel of the label, and the
intended type sizes of the text. End use product labeling
must comply specifically with the instructions in Section IV
(Regulatory Position and Rationale).
D. End Use Products containing the subject active ingredient
as one of multiple active ingredients
Within 12 months after the receipt of this document, you
must submit to the Product Manager:
Three copies of draft labeling, including the container
label and any associated supplemental labeling. Labeling
should be either typewritten text on 8-1/2 x 11 inch
paper or a mockup of the labeling suitable for storage
in 8-1/2 x 11 files. The draft labeling must indicate
the intended colors of the final label, clear indication
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of the front panel of the label, and the intended type
sizes of the text. End use product labeling must comply
specifically with the instructions in Section IV (Regulatory
Position and Rationale).
E. Intrastate Products containing the subject pesticide either
as sole active ingredient or in combination with other
active ingredients.
Applications for full Federal registration of intrastate
products are required to be submitted no later than July 13,
1988.
F. Addresses
The required information must be submitted to the following
address:
Richard F. Mountfort, Product Manager 23
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
The address for submissions to the Office of Compliance
Monitoring is:
Laboratory Data Integrity Program
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St. , SW
Washington, D.C. 20460.
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APPENDIX I
DATA APPENDICES
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TGUIDE-1
GUIDE TO TABLES
Tables A, Br and C contain listings of data requirements
for the pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
Table C contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format:
1. Data Requ irement (Column 1)- The data requirements are
listed in the order in which they appear in 40 CFR Part 158.
The reference numbers accompanying each test refer to the
test protocols set out in the Pesticide Assessment Guidelines,
which are available from the National Technical Information
Service, 5285 Port Royal Road, Springfield, VA 22161.
2. Test Substance (Column 2). This column lists the composition
of the test substance required to be used for the test, as
follows:
TGAI = Technical grade of the active ingredient
PAI = Pure active ingredient
PAIRA = Pure active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product
EP = End use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 CFR Part 158. The following
letter designations are used for the given use patterns:
A = Terrestrial, food
B = Terrestrial, non-food
C = Aquatic, food
D = Aquatic, non-food
E = Greenhouse, food
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I « Indoor
Any other designations will be defined in a footnote to the table.
46
-------
TGUIDE-2
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that satisfy this data
requirement. These data may be cited by other registrants
in accordance with data compensation requirements of
Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such data
do not fully satisfy the data requirement. In some cases,
the Agency may possess data on one of two required species,
or may possess data on one test substance but not all.
The term may also indicate that the data available to
EPA are incomplete. In this case, when the data are
clarified, or additional details of the testing submitted
by the original data submitter, the data may be determined
to be acceptable. If this is the case, a footnote to
the table will usually say so.
NO - EPA either possesses no data which are sufficient
to fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional infor-
mation.
5. Bibliographic^citation (Column 5). If the Agency has
acceptable data in its files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no
MRID number has been assigned. Refer to the Bibliography
Appendices for a complete citation of the study.
*>• Must^ additipnal data be submitted? (Column 6). This
column indicates whether the data must be submitted to the
Agency. If column 3 indicates that the Agency already has
data, this column will usually indicate NO. If column 3
indicates that the Agency has only partial data or no data,
this column will usually indicate YES. In some cases, even
though the Agency does not have the data, EPA will not require
its submission because of the unique characteristics of the
chemical; because data on another chemical can be used to
fulfill the data requirement; or because the data requirement
has been waived or reserved. Any such unusual situations
will be explained in a footnote to the table.
7. Timeframe for submission (Column 7). If column 5 requires
that data be submitted, this column indicates when the data
are to be submitted, based on the issuance date of the Regis-
tration Standard. The timeframes are those established either
as a result of a previous Data Call-in letter, or standardized
timeframes established by PR Notice 85-5 (August 22, 1985).
8. Footnotes (at the end of each table). Self-explanatory.
47
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DCPA
Test Does EPA Bibliographic Must Additional Timeframe for
Data Requirement SubstanceV Have Data? Citation2/ Data Be Submitted? Submission
§158.120 Product Chemistry
Product Identity and Composition
61-2 - Description of Beginning
Materials and
Manufacturing process TGAI No
61-3 - Discussion of Formation
of impurities TGAI No
Analysis and Certification of
*» product Ingredients
CD
62-1 - Preliminary Analysis TGAI No
Physical and Chemical Characteristics
63-2 - Color TGAI No
63-3 - Physical State TGAI No
63-4 - Odor TGAI No
63-5 - Melting point TGAI No
63-6 - Boiling Point TGAI No
YesV
YesV
Yes£/
YesV
YesVe/
YesV
YesV'V
YesV
6 months £/
6 months £/
12 Months V
6 Months
6 Months
6 Months
6 Months
6 Months
63-7 - Density, Bulk Density, or
Specific Gravity
TGAI
No
YesV
6 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DCPA (cont'd)
Test Does EPA Bibliographic Must Additional Timeframe for
Data Requirement SubstanceV Have Data? Citation^/ Data Be Submitted? Submission
$158.120 Product Chemistry
Physical and Chemical Characteristics (cont'd)
63-8
63-9
63-10
- Solubility TGAI or PAI No
- Vapor Pressure TGAI or PAI No
- Dissociation Constant TGAI or PAI No
YesV
YesV
YesV
6 Months
6 Months
6 Months
VO
63-11 - Octanol/Water partition
Coefficient
63-12 - pH
63-13 - Stability
63-17 - Storage Stability
Other Requirements!
64-1 - Submittal of Samples
PAI
TGAI
TGAI
No
No
No
YesV
PAI or TEP Yes
6 Months
6 Months
15 Months
N/A
N/A
NO
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DCPA (cont'd)
Footnotes t
V Test Substanovt TGAI » Technical Grade of the Active Ingredient; PAI - Pure Active Ingredient.
£/ Not applicable. Although product chemistry data may have been submitted in the past, the Agency has determined
that these data must be resubmitted for each pesticide. New requirements have been introduced and previously
submitted data must be updated. Therefore, bibliographic citations for the old data are not applicable.
£/ Complete information must be provided regarding the nature of the process (batch or continuous), the relative
amounts of beginning materials and the order in which they are added, the chemical equations for each intended
reaction, equipment used to produce each intermediate and the final product, reaction conditions, the duration
of each step of the process, purification procedures, and quality control measures. In addition, the name and
address of the manufacturer, producer, or supplier of each beginning material must be provided, along with
information regarding the properties of each beginning material used to manufacture each product. In order to
assess the potential for contamination with halogenated dibenzo-p-dioxins or dibenzofurans, the description of
the manufacturing process must also include the range of temperature conditions, pressure, and pH at each
reaction step. Refer to the data requirements set forth in the Agency's June, 1987 Data Call-in Notice for
analytical chemistry data on halogenated dibenzo-p_-dioxins/dibenzofurans in DCPA.
_V Timeframes for submitting data required in the Agency's June, 1987 for analytical chemistry data on halogenated
dibenzo-p-dioxins and dibenzofurnans in DCPA are specified that Notice.
5/ A detailed discussion of all impurities that are or may be present at _>. 0.1%, based on knowledge of the beginning
materials, chemical reactions (intended and side), in the manufacturing process, and any contamination during and
after production must be submitted. This discussion must also address the possible formation of halogenated
dibenzo-p-dioxins or dibenzofurans in DCPA, as required in the Agency's June, 1987 Data Call-in Noice.
6/ Five or more representative samples must be analyzed for the amount of active ingredient and each impurity for
~~ which a certified limit is required. Complete validation data (accuracy, precision) must be submitted for each
analytical method used.
7/ Physicochemical characteristics (color, physical state, odor, melting point, boiling point, specific gravity,
~~ solubility, vapor pressure, dissociation constant, KQW, pH, and stability) as required in 40 CFR 158.120 and
more fully described in the Pesticide Assessment Guidelines, Subdivision D, must be submitted.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DCPA (cont'd)
Footnotes (cont'd)i
£/ Data needed if the technical chemical is a liquid at room temperature.
V Data needed if the technical chemical is a solid at room temperature.
10/ Required if the technical chemical is organic and nonpolar.
^V Required if the test substance is dispersible with water.
N/A * Mot applicable.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DCPA
Data Requirement
Test Does EPA Bibliographic Must Additional
Substance1 / Have Data? Citation Data Be Submitted?
Tfeneframe for
Submission2/
S 158. 125 Residue Chemistry
171-2 - Product
171-4 - Nature of Residue
(Metabolism)
- Plants
in
- Livestock
171-4 - Residue Analytical
Method
- Plant Residues
- Animal Residues
171-4 - Storage Stability Data
PAIRA
PAIRA
Partially
TCAI and Partially
Metabolites
TGAI and
Metabolites
PAI or TEP
and Metabolites
Partially
Yes
00058377
00114677
40259101
Partially 00057629
00010026
00114642
00114643
00114644
00114654
00121864
00123748
40259001
00058378
00114643
00121864
Yes4/
Yes5/
Yes6/
18 Months
18 Months
33 Months
Reserved?/
Yes8/,9/
33 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DCPA (cont'd)
Data Requirement
S158.125 Residue Chemistry
171-4 - Magnitude of the Residue
- Crop Field Trials
- Crop Group #1 - Root and
1. Horseradish
£ 2. Potatoes
3. Radishes
4. Rutabagas
5. Sweet Potatoes
6. Turnips
7. Yams
- Crop Group 12 - Leaves of
Test
SubstanceV
Does FPA
Have Data?
Bibliographic Must Additional Timeframe for
Citation Data Be Submitted? Submission2/
Tuber Vegetables 10/
TEP
TEP
TEP
TEP
TEP
TEP
TEP
Root and Tuber
Yes
Partially
Yes
Yes
Yes
Yes
No
00058377 No
00018299 Yes11/ 36 Months
00090259
00114678
00121864 No
40240801 No
00090259 No
00114678
00114681
00090259 No
No32/
Vegetables^/
1. Radish Tops TEP Yes 00121864
2. Turnip Tops TEP Yes 00090259
No
No
-------
,E A
GENERIC D\TA REQUIREMENTS FOR DCPA (cont'd)
Data Requirement
S 158. 125 Residue Chemistry
171-4 _ Magnitude of the Residue
- Crop Field Trials (cont1
Test Does EPA
Substance^/ Have Data?
d)
Bibliographic Must Additional Tlmeframe for
Citation Data Be Submitted? Submission2/
- Crop Group #3 - Bulb Vegetables 13/
1 . Garlic
ji
•^
P*
2. Onions
TEP Yes
TEP Yes
00090259 No
00130562
00090259 No
00114631
00114681
- Crop Group #4 - Leafy Vegetables 147
1 . Cress , Upland
TEP Yes
2. Lettuce TEP Yes
- Crop Group #5 - Brassica Leafy Vegetables
1 . Broccoli
2. Brussels sprouts
3. Cabbage
4. Cauliflower
TEP Yes
TEP Yes
TEP Yes
TEP Yes
00033087 No
00090259
00033087 No
00090259
00090259 No
00114681
00090259 No
00090259 No
00114680
00090259 No
00114681
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DCPA (cont'd)
in
ui
Data Requirement
Test Does EPA Bibliographic
Substance^/ Have Data? Citation
Must Additional Timeframe for
Data Be Submitted? Submission2/
§158.125 Residue Chemistry
171-4 - Magnitude of the Residue
- Crop Field Trials (cont'd)
5.
6.
7.
Collards
Kale
Mustard Greens
- Crop Group #6 - Legume
1.
2.
Beans (Succulent
and Dried)
Soybeans
TEP
TEP
TEP
Yes
Yes
Yes
00090259
00090259
00090259
No
No
No
Vegetables *5/
TEP
TEP
- Crop Group #7 - Fruiting Vegetables
1. Eggplant TEP
2.
Peppers
TEP
Partially
Partially
(Except Cucurbits)
Partially
Partially
00017975
00058377
00090259
00111678
00017975
00058377
00090259
00114678
18/
00090259
00090259
00114680
Yesl6/ 35 Months
Yes£[/ 36 Months
Yes 36 Months
Yes^9/ 36 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DCPA (cont'd)
Data Requirement
§158.125 Residue Chemistry
171-4 - Magnitude of the Residue
Test
Substancel/
Does EPA Biblioaraphic
Have Data? Citation
Must Additional Timeframe for
Data Be Submitted? Submission2/
- Crop Field Trials (cont'd)
3. Tomatoes
- Crop Group |8 - Cucurbit
n
* 1 . Cucumbers
2. Melons
3. Squash, summer
4. Squash/ winter
5. Watermelon
TEP
Vegetables 21/
TEP
TEP
TEP
TEP
TEP
Partially
Partially
Partially
Partially
Partially
Partially
00090259
00114679
00114680
00090259
00090259
00090259
00090259
00090259
Yes »/
Yes22/
Yes2!/
Yes
Yes
Yes
36 Months
36 Months
36 Months
36 Months
36 Months
36 Months
- Crop Group #9 - Small Fruits and Berries 24/
o Strawberries
TEP
Partially
00090259
Yes2!/
36 Months
- Crop Group #10 - Cereal Grains 26/
o Corn, Field and Sweet
- Crop Group #11 - Foraqe,
o Corn Forage and Fodder
TEP
Partially
Fodder, and Straw of Cereal
TEP
Partially
00072099
Grains 28/
00072099
Yes2!/
Yes2?/
36 Months
36 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DCPA (cont'd)
Data Requirement
Test Does EPA Bibliographic Must Additional Timeframe for
Substance1/ Have Data? citation Data Be Submitted? Submission2/
S158.125 Residue Chemistry
171-4 - Magnitude of the Residue
- Crop Field Trials (cont'd)
- Crop Group f12 - Miscellaneous Commodities
o Cottonseed TEP Partially
- Meat/Milk/Poultry/Eggs
TEP
Partially
00114642
00114678
00114681
00038919
00058378
00114643
36 Months
Reserved31/
-------
TABF.E A
GENERIC DATA REQUIREMENTS FOR DCPA (cont'd)
Footnotes;
I/ Test Substance: TGAI - Technical Grade of the Active Ingredient; PAIRA - Pure Active Ingredient, Radiolabeled;
TEP - Typical End-use Product.
21 Data must be submitted within the indicated timeframe, based on the date of this Guidance Document.
3J Refer to Product Chemistry Data Requirement tables.
4/ Data must be submitted depicting the uptake, distribution, and metabolism of [^C]DCPA in lettuce, turnip, and
onion plants harvested after registered preeroergence, postemergence, or lay-by applications. Plants must be
sampled at regular intervals until maturity to characterize residues. All major components of the terminal
residues in mature plant parts must be identified (and confirmatory analytical procedures used to verify
y, identification) and quant itated. If the metabolism of DCPA in these three crops differs significantly, then
oo metabolism data for one representative commodity from each crop group for which registered uses exist will be
required. Representative samples from these tests must also be analyzed by enforcement methods to ascertain
that these methods are capable of determining all residues of concern.
5f Metabolism studies utilizing ruminants and poultry. Animals must be dosed for 3 days with ringlabeled
at a level sufficient to make residue identification and quantification possible. Milk and eggs must be collected
twice daily during the dosing period. Animals must be sacrificed within 24 hours of the final dosing. The dis-
tribution and identity of the residues must be determined in milk, eggs, liver, kidney, muscle, and fat. Samples
from the studies requested above should also be analyzed using current enforcement methods to ascertain the
validity of these methods for analysis of animal commodities. Upon receipt of the requested data, the need for
and nature of tolerances for DCPA residues in animal products will be determined.
6/ Residues of TPA in or on crop samples must be subjected to analysis by multiresidue protocols I-IV available from
the National Technical Information Service under Order No. PB 203734/AS. If the required plant metabolism data
reveal any additional residues of concern from DCPA, then these metabolites will also have to be subjected to the
multiresidue protocols.
If Should the required animal metabolism data indicate that registered uses may result in DCPA residues of concern
~ in animal feed items, then residues of concern of DCPA in animal commodities will need to be subjected to
analysis by multiresidue protocols I-IV (available from the National Technical Information Service under Order
No. PB 203734/AS).
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DCPA (cont'd)
Footnotes (cont'd):
&/ Storage intervals and conditions must be reported for the samples used to generate residue data submitted in
support of the established tolerances for DCPA residues in or on plant commodities. Data must also be provided
which depict the decline in residues during the storage intervals and under the conditions reported. In labora-
tory tests using fortified samples, the pure active ingredient and pure metabolites must be used. However, if
field-weathered samples are used, the test substance must be a typical end-use product.
9/ All residue data requested in this Standard must be accompanied by information specifying the storage intervals
and conditions for samples analyzed. Data must also be submitted depicting the storage stability of residues of
concern in appropriate sample substrates under the storage conditions and time intervals specified. In labora-
tory tests using fortified samples, the pure active ingredient and pure metabolites must be used. However, if
field-weathered samples are used, the test substance must be a typical end-use product.
m
*° J_0/ Use directions must be proposed and appropriate supporting residue data submitted for the additional represent-
ative group members carrot and sugar beet.
11/ Data must be submitted depicting the concentration, if any, of residues in chips, granules, and dried potatoes
processed from potatoes bearing measurable weathered residues. If the data indicate a potential for residue
concentration during processing, appropriate food/feed additive tolerances must be proposed.
12/ Use directions must be proposed, and appropriate supporting residue data submitted for additional representative
group member sugar beet tops.
13/ Use directions must be proposed, and appropriate supporting residue data submitted for the additional representative
group member green onions.
14/ Use directions must be proposed, and appropriate supporting residue data submitted for the additional representative
group members celery and spinach.
15/ Use directions must be proposed, and appropriate supporting residue data submitted for the additional representative
group member peas.
16/ Data must be submitted depicting residues of concern of DCPA in bean cannery residue processed from pods bearing
measurable weathered residues. If residue concentrations in cannery residue exceed the residue concentration
in beans, then an appropriate feed additive tolerance will have to be proposed.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DCPA (cont'd)
Footnotes (cont'd):
Ml Data must be submitted depicting residues of concern in grain dust, meal, hulls, soapstock, crude oil, and
refined oil processed from soybeans bearing measurable, weathered residues. If residues are found to concentrate
in any of these commodities, then appropriate food/feed additive tolerances must be established.
18/ Additional data to support the established tolerances for the combined residues of DCPA and its metabolites MTP
and TPA (calculated as DCPA) in or on the representative group members tomatoes and peppers (refer to the tomatoes
and peppers sections for details of data requirements).
19/ Data depicting residues of concern of DCPA in or on sweet peppers resulting from lay-by soil application (using
ground equipment) of a G formulation (in separate tests) aerial application of a WP formulation at 11 Ib ai/A.
Tests must be conducted in CA (18%), FL (23%) , and TX (16%) which collectively accounted for ca. 60 percent of
the 1982 U.S. sweet pepper acreage.
20/ Data must be submitted depicting DCPA residues of concern in or on tomatoes following postemergence broadcast
soil application (utilizing aerial equipment) of the 75% WP formulation and, in separate tests, a G formulation
(utilizing ground equipment) at 11 Ib ai/A. Tests must be conducted in CA (27%) and FL (50%), which collectively
produced ca. 77 percent of the 1984 U.S. tomato crop (Agricultural Statistics 1985, p. 172).
Tests must be submitted reflecting DCPA residues of concern in dry pomace, puree, catsup, and juice processed
from tomatoes bearing measurable weathered residues. If residues are found to concentrate in any of the above-
mentioned commodities, appropriate food/feed additive tolerances must be proposed.
21 / Additional data to support the established toerances for combined residues of DCPA and its metabolites MTP and
TPA (calculated as DCPA) in or on the representative group members cantaloupe, cucumber, and summer squash
(refer to melon, cucumber, and squash sections for details of data requirements).
22/ Data must be submitted depicting DCPA residues of concern in or on mature cucumbers harvested following
postemergence broadcast soil application of a G formulation at 11 Ib ai/A. Application must be made when
plants have four to five true leaves. Tests must be conducted in CA (8%), MI (18%), and NC (14%) since these
States represent the major U.S. cucumber-growing regions; production figures obtained from Agricultural
Statistics 1985, p. 157, appear in parentheses.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DCPA (cont'd)
Footnotes (cont'd):
23/ Data roust be submitted depicting DCPA residues of concern in or on mature cantaloupes harvested following
postemergence broadcast aerial application to seeded plantings (four to five leaf stage) of the 75% WP
formulation at V1 Ib ai/A. Tests must be conducted in CA (52/5) and TX (21/0; these States collectively
accounted for 75 percent of 1982 U.S. cantaloupe acreage.
Data must be submitted depicting DCPA residues of concern in or on mature cantaloupes harvested following
postemergence broadcast soil application to seeded plantings (four- to five-true-leaf stage) of a G formulation
at 11 Ib ai/A. Tests must be conducted in CA and TX (see footnote 18).
24/ Additional data to support the established tolerance for residues of DCPA in or on the representative group
member strawberries (refer to the Strawberries section for details of data requirements).
Use directions must be proposed, and appropriate supporting residue data submitted for additional represent-
ative group members (blackberries, blueberries, cranberries, and grapes).
t
t
25/ Data must be submitted depicting DCPA residues of concern in or on strawberries following early spring
postemergence broadcast soil application of a WP formulation at 11 Ib ai/A. Tests must include applications
with aerial equipment in 10 gal. of spray suspension/A. Tests must be conducted in CA, which produced 79 percent
of 1984 U.S. strawberry crop.
Data must be submitted depicting DCPA residues of concern in or on strawberries harvested following postemergence
broadcast soil application of a G formulation at 11 Ib ai/A. Tests must be conducted in CA.
26/ Additional data are required to support the established tolerances for residues of DCPA in or on the representative
group menber corn (refer to the Corn, field and sweet section for details of data requirements).
Use directions must be proposed and appropriate supporting residue data submitted for the additional group
members rice, sorghum, and wheat.
-------
TABLE A
GENERIC DATA REQUIREMENTS TOR DCPA (cont'd)
Footnotes (cont'd):
27/ Data must be submitted depicting residues of concern of DCPA in or on sweet corn (Including kernel plus cob with
husk renwved) and corn grain (including field and pop) harvested at maturity after a postemergence directed spray
with the 75% WP at 10.5 Ib ai/A when corn plants are > 18 inches in height. T«sts must be conducted in NC or SC,
the only States in which this use is registered.
Data must be submitted depicting DCPA residues of concern in milled products and grain dust from the milling
process (from wet millings starch, crude and refined oils and from dry millings, grits, meal, flour, crude and
refined oils) processed from field corn grain bearing measurable weathered residues. If residues concentrate
during processing in any of these commodities, then appropriate food/feed additive tolerances must be established.
28/ Additional data are required to support the established tolerances for residues of DCPA in or on the represent-
0, ative group member corn (refer to the Com forage and fodder section for details of data requirements).
" Use directions must be proposed and appropriate supporting residue data submitted for forage, fodder, and straw
of the additional group members wheat and any other cereal grain crop.
29/ Determination must be made of residues of concern of DCPA in or on field corn forage and fodder harvested after a
postemergence directed spray of the 75% WP at 10.5 Ib ai/A to corn plants > 18 inches in height. Test must be
conducted in NC or SC.
30/ Data must be submitted depicting DCPA residues of concern in meal, hulls, crude oil, refined oil, and soapstock
processed from cottonseed bearing measurable weathered residues. If residues concentrate in any of these
processed commodities, appropriate food/feed additive tolerances must be proposed.
31 / Upon receipt of the data requested in the section "Nature of the Reside in Animals," the need for, and the
nature of possible tolerances for DCPA residues in livestock will be assessed. Then the available data will
be evaluated as to its adequacy to support tolerances in animal commodities.
32/ Presently, DCPA is not federally registered for use on yams. DCPA is registered for use on sweet potatoes.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR IMPURITIES OBSERVED IN DCPA
Data Requirement
Test Does EPA Bibliographic Must Additional Timeframe for
Substance1/ Have Data? Citation Data Be Submitted? Submission2/
Impurities
Impurities
S158.125 Residue Chemistry
171-2 Chemical Identity V
171-3 Direction for use
171-4 - Nature of the Residue
(Metabolism)
- Plants 4/
- Livestock
«*» 171-4 - Residue Analytical Method
- Plant Residues Impurities
- Animal Residues Impurities
171-4 - Storage Stability Data impurities
171-4 - Magnitude of the Residue5/r6//7/f8/
- Crop Field Trials
Leafy Vegetables Group
o Lettuce
TEP
Brassica Leafy
Vegetables Group
o Broccoli
See Index
No
No
No
No
No
No
Yes
Reserved
Yes
Reserved
Reserved
TEP
No
YesV
YesW
18 Months
18 Months
33 Months
36 Months
36 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS MX IMPURITIES OBSERVED IN DCPA (cont'd)
Data Requirement
Test Does EPA Bibliographic Must Additional Timeframe for
Substance1/ Have Data? citation Tvita Be Submitted? Submission2/
5158.125 Residue Chemistry
171-4 - Magnitude of the Residue5/,6/7/8/
(cont'd)
- Crop Field Trials (cont'd)
Legume Vegetables Group
o Soybeans TEP
Fruiting Vegetables Group
(Except Cucurbits)
o Tomatoes TEP
Small Fruits and
Berries Group
o Strawberries TEP
Forage, Fodder, and Straw
of the Cereal Grains Group
o Corn Forage and Fodder TEP
Meat/Milk/Poultry/Eggs TEP
No
No
No
No
NO
yes11/
Yes1!/
Yes1*/
Reserved16/
36 Months
36 Months
36 Months
36 Months
-------
TABIJE A
GENERIC DATA REQUIREMENTS FOR IMPURITIES OBSERVED IN DCPA (cont'd)
Footnotes;
Reserved: Data may be needed pending results of additional residue studies submitted.
]_/ Test Substance: TGAI - Technical Grade of the Active Ingredient; PAIRA - Pure Active Ingredient, Radiolabeled;
TEP - Typical End-Use Product.
2J Data must be submitted within the indicated timeframe, based on the date of this Guidance Document.
3/ Refer to Product Chemistry Data Requirement Tables. If dioxins and/or benzofurans are found in technical
~~ DCPA the following residue data requirements for HCB may also be extended to these impurities.
4/ Data depicting the uptake, distribution, and metabolism of ^C-HCB in lettuce, turnip, and onion plants
harvested after treatments similar to the uses registered for DCPA (pre- and post-emergent and at layby)
are required. Plants must be sampled at regular intervals until maturity to characterize residues. These
studies should be carried out in conjunction with the required DCPA metabolism studies so that the decline
of these two chemicals can be compared. All major components of the terminal residue in mature plant parts
must be characterized and quantitated. If the metabolism of HCB in these crops differs significantly, then
additional studies on other crops may be required.
5/ Residue data for impurities should reflect application of TEP's containing current production lots
of technical DCPA.
6/ If detectable residues of impurities are observed in any of the test crops below, residue data will
be required for all crops having established tolerances.
TJ The analytical methodology for the residue studies for HCB on the seven representative commodities must
have a limit of quantitation of 1 ppb or better.
8/ Magnitude of residues in each raw agricultural commodity: The Agency intends to confirm the results reported
from these studies. Therefore each sample collected for analysis should be split into two samples, one
for analysis by the Registrant and one to be stored frozen by the Registrant until requested for analysis
by the Agency. The Registrant should take precautions to ensure that the two samples are equivalent, and both
samples should be treated and stored carefully to minimize sample integrity problems that may arise on
extended storage. The split samples must be clearly labeled, and are not to be submitted to the Agency until
specifically requested.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR IMPURITIES OBSERVED IN DCPA (cont'd)
Footnotes (cont'd):
9/ Residue data on impurities should reflect treatments with appropriate TEP's at the maximum
registered use and be carried out in the states of AZ and CA.
10/ Residue data on impurities should reflect treatments with appropriate TEP's at the the maximum
registered use and be carried out in CA.
ll/ Residue data on irrpurities should reflect treatments with appropriate TEPs at the maximum registered use
and be carried out in the States of AK, 10, MN and OH.
12/ Residue data on impurities should reflect treatments with appropriate TEPs at the maximum registered use and
be carried out in the states of CA and PL.
ot
q>13/ Should detectable residues be observed on tomatoes a processing study employing tomatoes bearing weathered
residues of the appropriate impurity will be required.
14/ Residue data on impurities should reflect treatments with appropriate TEP's at the maximum registered use
and be carried out in CA.
15/ Residue data on impurities should reflect treatments with appropriate TEP'S at the maximum registered use
and be carried out in the States of IL, 10, WI and OH.
16/ Should detectable residues of impurities be observed in feed items, then feeding studies on livestock
may be needed.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DCPA
Data Requirement
Test Use Does EPA Bibliographic
Substance^/ Patterns^'Have Data? Citation
Mast Additional Timeframe for
Data Be Submitted Submission 2/
SI 58. 130 Environmental Fate
Degradation Studies-Lab:
161-1 - Hydrolysis
Photodegradatipn
161-2 - In Water
161-3 - On Soil
161-4 - In Air
Metabolism Studies-Lab:
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic
TCAI
T3AI
TGAI
TGAI
TGAI
TGAI
TGAI
or PAIRA A,B
or PAIRA A,B
or PAIRA A
or PAIRA
or PAIRA A,B
or PAIRA A
or PAIRA
Yes 00114648
Nb
No
No
No
Nb
No
No
Yes
Yes
No
Yes
Yes
No
9 Months
9 Months
27 Months
27 Months
Aquatic
162-4 - Aerobic Aquatic TGAI or PAIRA No
Mobility Studies;
163-1 - Leaching and
Adsorption/
Desorption TGAI or PAIRA A,B No
163-2 - Volatility (Lab) TEP A No
Yes
Reserved4/
27 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DCPA (cont'd)
Data Requirement
Test Use Does EPA Bibliographic Must Additional Tinefrane for
Substance]/ Patterns£/Have Data? Citation Data Be Submitted Submission^/
S 158. 130 Environmental Fate
Mobility Studies (cont'd):
163-3 - Volatility (Field)
Dissipation Studies-Field:
164-1 - Soil
w 164-2 - Aquatic (Sediment)
an
164-3 - Forestry
164-4 - Combination and
Tank Mixes
164-5 - Soil, I/>ng-Tein»
Accumulation Studies:
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
TEP A
TEP A,B
TEP
TEP
TEP
TEP A
PAIRA A,B
TEP A,B
TEP
TGAI or PAIRA A,B
No
No
No
No
No
No
No
No
No
No
ReservedS/
Yes
No
No
No
Reserved*/
Yes
Reserved?/
No
Yes
27 Months
39 Months
12 Months
165-5 - In Aquatic Nontarget
Organisms
TEP
No
No
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DCPA (cont'd)
Test Use Does EPA Bibliographic Must Additional Tixnefrane for
Data Requirement Substance}/ Patterns'/Have Data? Citation Data Be Submitted Submission^/
Environmental Fate, continued
Groundwater Studies
• GroundwBter
Monitoring TEP A,B No
S 158. 140 Reentry Protection
Subpart K - Reentry
132-1 - Foliar Dissipation TEP A,H No
132-2 - Soil Dissipation TEP A No
133-3 - Dermal Exposure TEP A,H No
133-4 - Inhalation Exposure TEP A No
Yes§/ 27 Months
Yes?/ 27 Months
No
Conditional]^/
Condit tonal! O/
-------
TABLE A
GRNERIC DATA REQUIREMENTS FOR DCPA (cont'd)
Footnotes;
I/ Test Substance: TGAI - Technical Grade of the Active Ingredient; PAIRA - Pure Active Ingredient, Radiolabeled;
TEP - Typical End-Use Product.
21 Use patems 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; G - Forestry;
H - Domestic, Outdoor; I - Indoor.
V Data for individual studies must be submitted no later than the dates listed below.
4/ Pending toxicology considerations.
5/ Required if laboratory results show reason for concern.
•*j
0 6/ Required if pesticide residues do not readily dissipate in soil.
7J Required if confined studies show accumulation in rotational crops.
8/ Ground water monitoring protocol must be submitted, reviewed, and approved prior to conducting study.
£/ For crop tests, it will be sufficient to submit foliar dislodgeable residue dissipation data for only one of the
following crops: collards, kale, mustard greens, or turnip greens. The field test(s) must be run in an arid
environment such as a California inland valley. If the Registrant chooses, additional data may be submitted from
other, more-humid environments where residue dissipation may be faster. For home lawns, grass foliar dislodge-
able residue data must also be submitted, but the location of this test is not critical. The dislodgeable resi-
due levels that must be measured are HCB, 2,3,7,8-TCDD and DCPA.
1_Q/ Human-exposure monitoring data may be submitted at the Registrant's option. If dermal exposure data are submitted,
inhalation exposure data must also be submitted. If human exposure monitoring data are submitted, the
data submitted should be limited to foliar dislodgeable residues on treated crop leaves and on treated grass
leaves. These data may be used in conjunction with foliar dislodgeable and soil residue data for setting an
appropriate reentry interval.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DCPA
Data
S158.
Test
Requirement Substance^
.135 Toxicology
Use Does EPA Bibliographic
/ Patterns^/Have Data? Citation
Must Additional Timefrane for
Data Be Submitted Submission^'
Acute Testing;
81-1
81-2
^81-3
M
81-4
81-5
81-6
81-7
- Acute Oral
Toxicity - Rat
- Acute Denial
Toxicity - Rabbit
- Acute Inhalation
Toxicity - Rat
- Eye Irritation
- Dermal Irritation -
Rabbit
- Dermal Sensitization -
Guinea Pig
- Delayed
Neurotoxicity - Hen
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A,B,H No
A,B,H No
A,B,H No
A,B,H No
A.B.H No
A.B.H Yes 00150207
No
Yes
Yes
Yes
Yes
Yes
No
NoV
9 Months
9 Months
9 Months
9 Months
9 Months
Subchronic Testing:
82-1
- 90-Day Feeding
- Rodent
- Nonrodent (Dog)
TCAI
TGAI
A.B.H No
A.B.H No
YesV
No5/
15 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DCPA (cont'd)
Data Requirement
Test Use Does EPA Bibliographic Must Additional
Substance1/ Patterns2/Have Data? Citation Data Be Submitted
Time frame for
Submission V
§158.135 Toxicology
Subchronic Testing (cont'd)t
82-2 - 21-Day Dermal -
Rat
82-3 - 90-D«y Dermal -
Rabbit
82-4 - 90-Day Inhalation -
Rat
82-5 - 90-Day Neurotoxicity
Hen
Chronic Testingt
83-1 - Chronic Toxicity
- Rodent
- Nonrodent (Dog)
83-2 - Oncogenicity
- Rat (preferred)
- Mouse (preferred)
83-3 - Teratogenicity
- Rat
- Rabbit
TGAI
TGAI
TGAI
TGAI
A,B,H
No
No
No
No
Yes6/
Ho/
12 Months
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A
A
A
A
A
A
NO
Yes 00083584
NO
No
Yes 00160685
No
Yes
HO
Yes
Yes
NO
Yes
50 Months
50 Months
50 Months
15 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DCPA (cont'd)
Data Requirement
Test Use Does EPA Bibliographic Must Additional Tinefrane for
Substance1/ Patterns2/Have Data? Citation Data Be Submitted Submission V
§158.135 Toxicology
Chronic Testing (cont'd)i
83-4 - Reproduction - Rat TGAI
2-Generation
Mutagenicity Testing
84-2 - Gene Mutation
(Ames Test) TGAI
84-2 - Structural Chromosomal
Aberration TGAI
84-4 - Other GenotoJdc
Effects
Special Testing
65-1 - General
Metabolism
85-3 - Dermal Absorption
-Rat
TGAI
A,B,H
A,B,H
A,B,H
PAI or PAIRA A,B,H
PAIRA A,B,H
No
Yes
No
No
No
No
Yes
00100775
No
Yes
Yes
50 Months
12 Months
12 Months
Yes 24 Months
Reserved10/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DCPA (cont'd)
Footnotes;
I/ Test Substance - TGAI - Technical Grade of the Active Ingredient; PAI - Pure Active Ingredient; PAIRA - Pure
Active Ingredient, Radiolabeled; Choice - Choice of several test substances determined on a case-by-case basis.
2/ The use patterns are as follows: A - Terrestrial, Food Crop; B - Terrestrial, Nonfood Crop; C - Aquatic,
Food Crop; D - Aquatic, Nonfood; E - Greenhouse, Food Crop; F - Greenhouse, Nonfood; G - Forestry; H - Domestic,
Outdoor; I - Indoor; IP - Industrial Preservative.
_3/ Unless otherwise specified, data must be submitted no later than the number of months listed below, from the
~~ date of receipt of this Standard.
kj This test is required for compounds which are organophosphate inhibitors of cholinesterase, or related to such
~~ inhibitors or metabolites of such inhibitors. DCPA is not an organophosphate; therefore, a study is not required.
-j
* 5/ This study will not be required if an acceptable chronic study is submitted.
6/ This study must be performed on the rat.
TJ This study is not required because existing acceptable end-uses should not result in repeated human skin
contact.
8/ This study la not required because existing acceptable end-uses should not result in repeated Inhalation
exposure.
9/ Since an acute neurotoxicity study is not required for this compound and there is no evidence of neurotoxicity
~~ in mammalian species, this study is not required.
10/ This study maybe required if the product chemistry and dermal exposure data required by this Standard do not
produce an acceptable oncogenic risk when a dermal absorption of 100% is utilized in the risk calculations.
If required, the study will follow the dermal adsorption of the impurities, 2,3,7,8-TCDD and/or HCB in
DCPA at the combined dermal exposures (mg/cm2) of DCPA and the impurities that have been found to occur
during use.
-------
TABIJE A
GENERIC DATA REQUIREMENTS FOR DCPA
ot
Data
Test Use Does EPA Bibliographic Must Additional Tlroeframe for
Requirement Substance]/ Patterns^/ Have Data? Citation Data Be Submitted Submission £/
S 158. 145 Wildlife and Aquatic Organisms
Avian and Mammalian Testing
71-1
71-2
71-3
71-4
71-5
- Acute Avian Oral
Toxicity
• Avian Subacute
Dietary Toxicity
- Upland Game Bird
and
- Waterfowl
- Wild Mammal Toxicity
- Avian Reproduction
- Upland Game Bird
- Waterfowl
- Simulated Field
Testing
- Mammals
- Birds
- Actual Field
Testing
- Mammals
- Birds
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TEP
TEP
TEP
TEP
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
No
No
No
No
No
No
No
No
No
No
Yes
Yes
Yes
NoV
Nq5/
NoV
No*/
No*/
*/
Nq6/
9 Months
9 Months
9 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DCPA (cont'd)
Data
Test Use Does EPA Bibliographic Must Additional Tlnefrane for
Requirement Substance]/ Patterns2/ Have Data? Citation Data Be Submitted Submission^/
S158.145 Wildlife and Aquatic Organisms (cont'd)
Aquatic Organisms Testing
72-1
72-2
72-3
72-4
72-5
- Freshwater Fish
Toxicity
- Coldwater Fish
Species
- Warrawater Fish
Species
- Acute Toxicity
to Freshwater
Invertebrates
- Acute Toxicity to
Estuarine and
Marine Organisms
- Fish
- Mollusk
- Shrimp
- Fish Early Life
Stage
- Aquatic Invertebrate
Life Cycle
- Fish Life Cycle
TGAI
TGAI, TEP
TGAI, TEP
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A,B
A,B
A,B
A,B
A,B
A,B
A.B
A,B
A,B
No Yes 9 Months
No Yes 9 Months
Yes 40098001 No
Yes 40228401 No
Yes 40228401 No
Yes 40228401 No
No No5/
No NoJ>/
No Nq5/
-------
A
GENERIC DATA REQUIREMENTS FOR DCPA (cont'd)
Test Use Does EPA Bibliographic Must Additional Tfcneframe for
Data Requirement Substance]/ Patterns^/Have Data? Citation Data Be Submitted Submission 3
§158.145 Wildlife and Aquatic Organisms (cont'd)
Aquatic Organisms Testing
72-6 - Aquatic Organism
Accumulation TGAI, PAI, or
Degradation
Product
- Crustacean A,B No No5/
- Fish A,B No NqV
- Insect Nymph A,B No NqV
- Mollusk A,B No NoV
72-7 - Sinnilated Field Testing
- Aquatic
Organisms TEP A,B No
- Actual Field Testing
- Aquatic
Organisms TEP A,B No
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DCPA (cont'd)
Footnotes;
\J Test Substance: TGAI - Technical Grade of the Active Ingredient; PAI - Pure Active Ingredient; TEP - Typical
~~ End-Use Product.
2/ The use patterns are 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 - Domestic, Outdoor; I - Indoor.
3/ No data requirement for formulated products, Unless otherwise specified, data must be submitted no later than
the number of months listed below, from the date of reciept of this Standard.
4/ Available information indicate DCPA is low in toxicity to mammals and its use pattern will not cause adverse
*J effects to wild mammals.
00
V Not applicable for purposes of this Standard.
6/ These data are required if available information indicate an acute hazard. Available information do not
trigger this requirement.
TJ These studies are required if available acute toxicity data on aquatic organisms indicate an acute hazard.
Available data do not trigger these requirements.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DCPA
\o
Test Use Does EPA Bibliographic
Data Requirement Substance^/ Patterns^/Have Data? Citation
SI 58. 150 Plant Protection
121-1 - Target Area
Phytotoxiclty
Nontarget Area Phytotoxiclty
Tier I
122-1 - Seed Germination/
Seedling Emergence
122-1 - Vegetative Vigor
122-2 - Aquatic Plant
Growth
Tier II
123-1 - Seed Germination/
Seedling Emergence
123-1 - Vegetative Vigor
123-2 - Aquatic Plant
Growth
Tier III
124-1 - Terrestrial Field
124-2 - Aquatic Field
TEP
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TEP
TEP
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
No
No
No
No
No
ND
No
No
Na
Must Additional
Data Be Submitted
No3/
Yes
Yes
Yes
Reserved*/
Reserved*/
Reserved*/
Reserved5/
ResetvedS/
Tinefraroe for
Submission^/
9 Months
9 Mmths
9 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DCPA
Data Requirement
Test Use Does EPA Bibliographic Must Additional Tiroefrane for
Substance1 / Pattern2/ Have Data? Citation Data Be Submitted Submission^/
TCAI
TEP
SI58.155 Nontarget Insect
Nontarget Insect Testing -
Pollinators;
141-1 - Honey Bee Acute
Contact Toxicity
w141-2 - Honey Bee - Toxicity
0 of Residues on
Foliage
141-4 - Honey Bee Subacute
Feeding Study (Reserved)V
141-5 - Field Testing for
Pollinators TEP
Nontarget Insect Testing -
Aquatic Insects;
142-1 - Acute Toxicity to
Aquatic Insects (Reserved)^/
142-2 - Aquatic Insect Life
Cycle Study (Reserved)^/
142-3 - Sijnulated or Actual
Field Testing for
Aquatic Insects (Reserved)^/
A,B
A,B
A,B
Yes
No
00018842
No*/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DCPA (cont' d)
Test Use Does EPA Bibliographic Must Additional Tlmeframe for
Data Requirement Substance]/ Pattern^/ Have Data? Citation Data Be Submitted^' Submission
SI58.155 Nontarget Insect (cont'd)
143-1 - Nontarget Insect (Reserved)^/
thru Testing - Predators "~
143-3 - and Parasites
00
-------
TABLE A
GENERIC MTA REQUIREMENTS FDR DCPA (cont'd)
Footnotes;
jy Test Substance: TGAI - Technical Grade of the Active Ingredient; TEP - Typical End-Use Product.
2/ The use patterns are 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 - Domestic, Outdoor; I - Indoor.
31 Unless otherwise specified, data must be submitted no later than the number of months listed below, from the
date of reciept of this Standard.
4/ As data from the acute contact test indicate low toxicity, no further testing is required.
CD
N 5/ Reserved pending development of test methodology.
6/ Reserved pending Agency decision as to whether the data requirement should be established.
-------
TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR DCPA MANUFACTURING-USE PRODUCTS
Data Requirement
Does EPA Must Additional
Have Data To Data Be Submitted
Test Satisfy This Bibliographic Under Section
SubstanceV Requirement?^/ CitationV 3(c)(2)(B)7
Timeframe for
Data Submission
$158.120 Product Chemistry
oo
Product Identity and Composition
61-1 - Product Identity
and Disclosure of
Ingredients MP
61-2 - Description of Beginning
Materials and Manufac-
turing Process MP
61-3 - Discussion of Formation
of Impurities MP
Analysis and Certification of
product Ingredients
62-1 - Preliminary Analysis
of Product Samples MP
62-2 - Certification of
Ingredient Limits MP
62-3 - Analytical Methods
to Verify Certified
Limits MP
No
No
No
No
No
No
YesV
YesV
Yes*/
YesV
YesV
YesV
6 months4/
6 months4/
6 months4/
12 months4/
12 monthsV
12 months4/
-------
TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR DCPA MANUFACTURING-USE PRODUCTS (cont'd)
Data Requirement
Does EPA
Have Data To
Test Satisfy This
Subs tancej_/ Requi remen t?£/
Bibliographic
Citation?/
Must Additional
Data Be Submitted
Under Section
3(c)(2)(B)7
Timeframe for
Data Submission
$ 158. 120 Product Chemistry
physical and Chemical Characteristics
63-2
63-3
63-4
2 63-7
63-12
- Color MP No
- Physical State MP NO
- Odor MP No
- Density, Bulk Density, or
Specific Gravity MP No
- pH MP No
Ye»^P_/ 6 Months
yesj£/ 6 Months
yes^P/ 6 Months
yes^£/ 6 Months
yesJO/,JJ/ 6 Months
63-14 - Oxidizing or Reducing
Action
63-15 - Flammability
63-16 - Explodability
63-17 - Storage Stability
63-18 - Viscosity
63-19 - Miscibility
63-20 - Corrosion
Characteristics
MP
MP
MP
MP
MP
MP
MP
No
No
No
No
No
No
No
yeslO/,12/ 6 Months
6 Months
6 Months
yes10/ 15 Months
6 Months
6 Months
Yes1 O/ 15 Months
-------
TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR DCPA MANUFACTURING-USE PRODUCTS (cont'd)
Data Requirement
Does EPA
Have Data To
Test Satisfy This
Substancey Requirenent?£/
Bibliographic
Citation2/
Must Additional
Data Be Submitted
Under Section
3(c)(2)(B)?
Tlraefrarae for
Data Submission
8158.120 Product Chemistry
Other Requirements;
64-1 - Submittal of Samples
MP
No
No
00
-------
TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR DCPA MANUFACTURING-USE PRODUCTS (cont'd)
\J Test Substancei MP - Manufacturing-Use Product.
2/ Not applicable. Although product chemistry data may have been submitted in the past, the Agency has determined
that these data must be resubmitted for each pesticide. New requirements have been introduced and previously
submitted data must be updated. Therefore, bibliographic citations for the old data are not applicable.
3/ The chemical name and nominal concentration of each impurity for which a certified limit is required must be
submitted. In addition, the chemical name, nominal concentration, Chemical Abstracts Service (CAS) Registry
Number, and purpose of the active ingredient and each intentionally added inert must be provided. For the
active ingredient, the following must also be provided: the product name, trade name, and common name? the
molecular structural, and empirical formulas; the molecular weight or weight range; and any experimental or
internally assigned company code numbers.
4/ Timeframes for submitting data required in the Agency's June, 1987 Data Call-in Notice for analytical chemistry
m data on halogenated dibenzo-p-dioxins or dibenzofurans in DCPA are specified in that Notice.
Ol
5/ Complete information must be provided regarding the nature of the process (batch or continuous), the relative
amounts of beginning materials and the order in which they are added, the chemical equations for each intended
reaction, equipment used to produce each intermediate and the final product, reaction conditions, the duration
of each step of the process, purification procedures, and quality control measures. In addition, the name and
address of the manufacturer, producer, or supplier of each beginning material must be provided, along with infor-
mation regarding the properties of each beginning material used to manufacture each product. In order to assess
the potential for contamination with halogenated dibenzo-p-dioxins or dibenzofurans, the description of the
manufacturing process must also include the range of temperature conditions, pressure, and pH at each reaction
step. Refer to the data requirements set forth in the Agency's June, 1987 Data Call-in Notice for analytical
chemistry data on halogenated dibenzo-p-dioxins or dibenzofurans in DCPA.
6/ A detailed discussion of all impurities that are or may be present at 2. 0.1%, based on knowledge of the beginning
materials, chemical reactions (intended and side) in the manufacturing process, and any contamination during and
after production must be submitted. This discussion must also address the possible formation of halogenated
dibenzo-p-dioxins or dibenzofurans in DCPA, as specified in the Agency's June, 1987 Data Call-in Notice.
7/ Five or more representative samples must be analyzed for the amount of active ingredient and each impurity for
which a certified limit is required. Complete validation data (accuracy, precision) must be submitted for each
analytical method used.
-------
TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR DCPA MANUFACTURING-USE PRODUCTS (cont'd)
*-^—^— . . • .— - —. 1 -__._. T . _ ._ _ . _ _ Lr ^_ L | | | | L ._ L —.
Footnotes (cont'd)«
8/ Upper and lower limits for the active ingredient and each intentionally added inert, and upper limits for each
impurity present at _> 0*1% (w/w) and each "toxicologically significant" impurity present at < 0*1% (w/w) must be
provided, certified, and validated by sample analysis using analytical procedures for which accuracy and precision
data have been provided. Limits for impurities not associated with the active ingredient need be provided only if
they are considered to be of toxicological significance, regardless of the concentration at which they are present*
The Agency's Data Call-in Notice of June, 1987 for analytical chemistry data on halogenated dibenzo-p-dioxins or
dibenzofurans in DCPA requires certification of limits of any halogenated dibenzo-p-dioxin or dibenzofuran detected
in the product. Certifications must be submitted on EPA Form 8570 (Rev. 2-85).
9/ Analytical methods must be provided to determine each toxicologically significant impurity and intentionally added
inert for which certified limits are required. Each method must be accompanied by validation studies indicating
its accuracy and precision. These methods must be suitable for enforcement of certified limits. The Agency's
June, 1987 Data Call-in Notice for analytical chemistry data on halogenated dibenzo-p-dioxins and dibenzofurans in
DCPA requires submission of an analytical method that meets the specifications given in that Notice.
JJ) Physicochemical characteristics (color, physical state, odor, specific gravity, pH, oxidizing or reducing action,
flammability, explodability, storage stability, viscosity, miscibility, and corrosion characteristics) as required
in 40 CFR 158.120 and more fully described in the pesticide Assessment Guidelines, Subdivision D, must be submitted.
11/ Required if the test substance is dispersible with water.
12/ Required if the product contains an oxidizing or reducing agent.
13/ Required if the product contains combustible liquids.
14/ Required if the product is potentially explosive.
15/ Required if the product is a liquid.
16/ Required if the product is a liquid and is to be diluted with petroleum solvents.
-------
TABLE B
00
oo
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE
Data Requirement Test Use Does EPA
Substance1/ Pattern2/ Have Data?
§158*135 Toxicology
ACUTE TESTING
81-1 - Acute Oral Toxicity - Rat KP A,B,H No
81-2 - Acute Dermal Toxicity MP A,B,H No
- Rabbit
81-3 - Acute Inhalation Toxicity MP A,B,H No
- Rat
81-4 - Primary Eye MP A,B,H No
Irritation - Rabbit
81-5 - Primary Dermal MP A,B,H No
irritation - Rabbit
81-6 - Dermal Sensitization - MP A,B,H No
Guinea Pig
1/ Composition: MP - Manufacturing Use product
PRODUCTS CONTAINING DCPA
Bibliographic Must Additional Time Frt:n
Citation Data be fo
Submitted? Submission
Yes 9 Montiia
Yea 9 Months
Yes 9 Months
Yea 9 Months
Yes 9 Months
Yes 9 Months
2/ Use patterns are coded as follows: A - Terrestrial, Food Crop; B - Terrestrial, Nonfood crop* C - Aquatic, Pood
Crop; D • Aquatic, Nonfood Crop; E - Greenhouse, Food Crop; F • Greenhouse, Nonfood crop* G • Forestry;
H » Domestic, outdoor; I - Indoor.
BEST AVAILABLE COPY
-------
APPENDIX II
LABELING APPENDICES
89
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SUMMARY-1
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 the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. [40 CFR 162.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency.
[40 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 label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
[40 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 must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. [40 CFR 162.10(g)]
90
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SUMMARY-2
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. [40 CFR 162.10(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING.
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. [40 CFR 162.10 (h)(l)(i))
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation toxicity, the word "Poison" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. [40 CFR 162.10(h)(1)(i)]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. [40 CFR 162.10(h)(1)(iii)]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR 162.10(h)(l)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR 162.10(h)(2)].
91
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SUMMARY-3
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, Injury or damage. [40 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. [40 CFR 162.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria
in the PHYS/CHEM Labeling Appendix. The requirement is
based on the results of the flashpoint determinations and
flame extension tests required to be submitted for all products.
These statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
'Physical/Chemical Hazards." Note that no signal word is
used in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - 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 IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR 162.11(c). You will be notified of
the Agency's classification decision.
92
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SUMMARY-4
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement nmst be set in type of the same minimum size
as required for human hazard signal word (see table in 40
CFR 162.10(h)(1)(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). If use is restricted to certified applicators,
the following statement is required: "For retail sale
to and use only by Certified Applicators or persons
under their direct supervision and only for those uses
covered by the Certified Applicator's Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label uses that
are unrestricted, but you may not distinguish them
on the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
93
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SUMMARY-5
Item IDA. REENTRY STATEMENT - If a reentry Interval
has been established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix II,
STOR, PEST/DIS, and CONT/DIS to determine the storage and
disposal instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment.
[40 CFR 162.10]
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from those
accepted in connection with registration of the product. It
should be made part of the response to this notice and submitted
for review.
94
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SUMMARY-6
IABELING REQUIREMENTS CF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
0
J1
6A
6B
7
7A
7B
IABI& ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
If registrant Is not the producer, must
be qualified by "Packed for ... ,"
"Distributed by. . .." etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
-------
StJMMARY-7
ITEM
~7cT
7D
SO
tt\
7E
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others :
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
-------
SUMMARY-8
ITEM
8C
9A
9B
B 10A
j
10B
IOC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150'F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMEN? ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHVS/CHEM
Includes a statement of die terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be sane type size as
signal word.
Required statement is:
"It is a violation of Federal law
to use this product in a manner
Inconsistent with its labeling."
Must be set apart and clearly distin-
guishable from from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
so
-------
APPENDIX III
USE INDEX APPENDICES
98
-------
EPA Compendium of Acceptable Dies
DIMETHYL TETRACHLOROTEREPHTHALATE
TABLE OF CONTENTS
Site Name
TERRESTRIAL FOOD CROP 3
(Agricultural Crops) 3
TERRESTRIAL NONFOOD CROP 10
(Ornamental Plants and Forest Trees) 10
Abelia 10
African Violet 12
Ageratum 12
Ajuga 12
Alyssum 12
Arborvitae 10
Ash 10
Aster 12
Athletic Field/Turf 14
Austrian Pine 10
Azalea 10
Baby's Breath 12
Barberry 10
Beans 3
BelIflower 12
Bermudagrass (from sod) 14
Birch 10
Black-Eyed Beans 3
Bleeding Heart 12
Bloodleaf 12
Blue Bedder Salvia 12
Blue Spruce 10
Border Forsythia 10
Boston Ivy 10
Boxwood 10
Broccoli 3
Broccoli (Chinese) (tight heading varieties) 4
Brussels Sprouts 3
Bugloss 12
Cabbage 3
California Privet 10
Camellia 10
Candle Larkspur 12
Candytuft 12
Cantaloupe 4
Cape Marigold 12
Cauliflower 3
Chestnut 10
Chinese Cabbage (tight heading varieties) 4
Chrysanthemum 12
Cinquefoil 12
Coleus 12
Collards 5
Columbine 12
Coneflower 12
Issued: 5-28-86 I-078701-i
Provisional Update: 4-05-88 99
-------
EPA Compendium of Acceptable Uses
DIMETHYL TETRACHLOROTEREPHTHALATE
TABLE OF CONTENTS
Site Name
Coral Bells 12
Coreopsis 12
Corn, Field 5
Corn, Sweet 5
Cosmos 12
Cotoneaster 10
Cotton 6
Cottonwood 10
Creeping Juniper 10
Creeping Thyne 12
Cress, Upland 6
Cucumber 4
Cuphea 10
Cypress 10
Dahlias 12
Daisies 12
Deutzia 10
Dogwood 10
Dry Beans 3
Dwarf Forsythia 10
Eggplant 6
Elaeagnus 10
Elm 10
English Ivy 10
English Ivy (ground cover) 14
Euonymus 10
Evening Primrose 12
Fernleaf Yarrow 12
Feverfew 12
Field Beans 3
Fir 10
Flowering Crabapple 10
Forget-Me-Not 12
Forsythia 10
Four-0'Clock 12
Foxglove 12
Gaillardia 12
Garlic 6
Geranium 12
Gladiolus 12
Gold-Dust 12
Golden Marguerite 12
Goldentuft 13
Golf Fairways/Golf Greens 14
Ground-Hemlock 10
Gun 10
Hawthorn 10
Heath 10
Holly 10
Honeydew Melon 4
Issued: 5-28-86 I~aW01-ii
100
-------
EPA CovpendiuB of Acceptable Uses
DIMETHYL TETRACHLOROTEREPHTHALATE
TABLE OF CONTENTS
Site Kane Page
Honeysuckle 10
Horseradish 7
Hybrid Tea Roses 10
Hydrangea 10
Iris 13
Ivy (ground cover) H
Japanese Andromeda 10
Japanese Barberry 10
Japanese Privet 10
Japanese Tew 10
Juniper 10
Kale 5
Lantana 10
Larkspur 13
Lavender Cotton 13
Leeks 7
Lettuce (head) 7
Lettuce (leaf) 7
Ligustrun 10
Lilac 10
Lilies 13
Loblolly Pine 10
Locust 11
Lupines 13
Magnolia 11
Maple 11
Marigold 13
Mentor Barberry 11
Mock-Orange 11
Morningglory 13
Mountain-Laurel 11
Mourning Bride 13
Mourning Pink 13
Multiflora Rose 11
Mung Beans 3
Mustard Greens 5
Nasturtium 13
Oak 11
Onions 6
Ornamental Lawns 15
Orpine 13
Pachysandra 11
Pachysandra (ground cover) 14
Paxistiaa 11
Peonies 13
Peppers 6
Petunias 13
Pine 11
Pittosporua 11
Podocarpus 11
Issued: 5-28-86 I-078701-iii
101
-------
EPA Compendium of Acceptable Uses
DIMETHYL TETRACHLOROTEREPHTHALATE
TABLE OF CONTENTS
Site Naae
Ponderosa Pine 11
Poplar 11
Potato (whole or cut pieces) 8
Purple Coneflower 13
Radish (grown for seed) 8
Red Pine 11
Redbud 11
Rhododendron 11
Rose 11
Rose Moss 13
Russian Olive 11
Salvia 13
Scabiosa 13
Scarlet Sage 13
Scotch Pine 11
Shore Pine 11
Snap Beans 3
Snapdragon 13
Southern Peas (black-eyed beans) 3
Soybeans 8
Spiderwort 13
Spirea 11
Spruce 11
Squash 4
Stocks 17
Stonecrop 13
Strawberry 9
Strawflower 13
Sundrops 13
Sunflower 13
Sweet Pea 13
Sweet Potatoes 9
Sycamore 11
Tomato 9
Torch Lily 13
Tree Peony 11
Tuliptree 11
Turnip (greens) 5
Turnip (roots) 5
Varigated Privet 11
Verbena 13
Viburnum n
Violets 13
Wallflower 13
Walnut 11
Watermelon 4
Weigela H
White Spruce H
Willow H
Wormwood 11
Issued: 5-28-86 I-078701-iv
102
-------
EPA Conpendiua of Acceptable Uses
DIMETHYL TETRACHLOROTEREPHTHALATE
TABLE OF CONTENTS
Site Haae Page
Jams 9
Yarrow 13
Tellow Pine 11
Yew 11
Zinnia 13
Zoysia Grass (from sod) 14
Issued: 5-28-86 I-Q?|J01-v
103
-------
EPA Compendium of Acceptable Uses
DIMETHYL TETRACHLOROTEREPHTHALATE*
TYPE PESTICIDE; Herbicide
FORMULATIONS:
FI (SOX, 90X)
6 (1.151, 1.25X, 1.27X. 1.51, 1.72X, 21, 2.28X, 2.3X, 2.31X. 2.411,
2.5X, 2.871, 2.9X, 31, 3.28X, 3.47X, 3.85X, 4.16X. 4.4X. 4.5X, 4.6%,
4.8X. 4.87X. 4.95X, 51, 5.5X. 5.7X, 5.75X, 6X, 6.14X, 6.3X, 6.86X,
6.9X. 7X, 10X, 24X)
WP (25X8 50%. 60X. 75X)
F1C (54.9X)
SC/L (6X)
GENERAL WARNINGS AND LIMITATIONS: A selective herbicide used to control
preemergent broadleaf weeds and grasses in agricultural crops, ornamen-
tals, and turf grasses. This chemical is toxic to fish. Do not apply
where runoff is likely. Do not apply when conditions such as high salt
concentrations, seedling disease, cold weather, deep planting, excessive
noisture, or drought may weaken crops normally tolerant to this product.
Do not use on peat or muck soils. For areas under tillage, apply to soil
surface within 2 to 3 days following cultivation to prevent further weed
germination. Injury may result to the following crops, if replanting is
required due to early crop failure: onions, seeded melons, potatoes, toma-
toes, eggplants, or peppers. Replanting of any agricultural crop (in
treated soil) other than those included in this report within 8 months of
application may result in injury to that crop. All crops listed in this
report may be planted following a harvest of a treated crop. Weed control
up to 4 months may be expected following proper application. Do not soil
incorporate deeper than 2 inches. Applications may be made by spray, fer-
tilizer spreader, or shaker can.
Environmental Hazard Statements: Do not apply directly to water or wet-
lands (swamps, bogs, marshes, and potholes). Do not contaminate water by
cleaning of equipment or disposal of wastes. For granular formulations,
collect and incorporate granules spilled on soil surface.
Wear goggles or face shield, long-sleeved shirt and long pants when mix-
ing, loading and applying this product. Wash thoroughly with soap and
water after handling. Remove contaminated clothing and separately launder
clothing before reuse. For granular or wettable powder formulations, a
dust mask or similar protection against particle inhalation must be worn
when mixing, loading and applying this product. For commercial greenhouse
uses, only the applicator is permitted to be in the greenhouse during ap-
plication of DCPA. Greenhouse vents Bust be open during application and
remain open for at least 1 hour after application. For homeowner or house-
hold uses, wear goggles or face shield when handling. Remove contaminated
clothing and separately launder clothing before reuse. Wash thoroughly
with soap and water after handling. For agricultural uses, do not enter
treated areas for 24 hours after application unless wearing long-sleeved
shirt, long pants, and a dust mask or similar protection against particle
inhalation.
Agricultural Crop Tolerances (other than those listed in the text):
Rutabagas 2.0 ppm
*dacthal
DCPA
Issued: 5-28-86 1-078701-1
Provisional Update: 4-05-88 104
-------
EPA Compendium of Acceptable Uses
DIMETHYL TETRACHLOROTEREPHTHALATE
TIME REOUTRED FOR CONTROL; Hot located.
EHUOTOXICITY TO TARGET WEEDS; Hot located.
PHYTOTOXICITY TO CROPS: Hot located.
MODE OF ACTION: Inhibits cell division and root tip growth.
BROADLEAF WEEDS CONTROLLED;
Broadleaf veeds
Carpetweed
Chickweed
Clover
Common chickweed
Dodder
Florida pusley
Lambsquarters
Nodding spurge (a)
Palmer amaranth
Prostrate spurge
Purslane
Redroot pigweed (a)
Redstem filaree
Sesbania
Slender speedwell
Spiny amaranth
Spotted spurge (a)
Witchweed
Wright groundcherry (a)
(a) Use the higher dosage.
GRASSES AND OTHER MONOCOTS CONTROLLED:
Annual bluegrass (a)
Annual grasses
Barnyardgrass (a)
Browntop panicun (a)
Crabgrass
Fall panicua
Goosegrass (a)
Green foxtail
Johnsongrass (from seed) (a)
Large crabgrass
Lovegrass
Sandbur (a)
Smooth crabgrass
Stinkgrass
Texas panicum
Witchgrass
Yellow foxtail
(a) Use the higher dosage.
Issued: 5-28-86 I-q7#g01-2
-------
Site. Dosage and
Formulation
(Ib a.i./A)
EPA Compendium of Acceptable Uses
DIMETHYL TETRACHLOROTEREPHTHALATE
Tolerance. Use. Limitations
TERRESTRIAL FOOD CROP
(Agricultural Crops)
General Warnings and Limitations: If weeds have emerged, crops should
be cultivated or weeded prior to application.
Beans (dry, field,
snap)
Mung Beans
Southern Peas
(black-eyed beans)
2.0 ppm (beans, snap, succulent)
2.0 ppm (beans, mung, dry)
2.0 ppm (beans, field, dry)
2.0 ppm (peas, southern, black-eyed)
Do not graze treated areas or feed plant parts to
livestock.
5-11 Preemergence. Broadcast or band application. Soil
(2X, 2.28%, 2.41X, treatment. Apply preplant incorporated at seeding
2.5X, 4.16X, 5X G) or at transplanting. For the wettable powder for-
(25X, 75X WP) roulation, apply in 20 gallons of water per acre by
ground or in 10 gallons of water per acre by air.
Broccoljl
Brussels Sprouts
Cabbage
Cauliflower
1.0 ppm
Do not graze treated areas or feed plant parts to
livestock.
5-11 Preemergence. Broadcast or band application.
(2X, 2.28%, 2.5X, Soil treatment. Apply preplant incorporated at
4.16X, 5X, 6X G) planting or at transplanting. For the wettable
(25X, SOX, 75X WP) powder formations, apply in 20 gallons of water
per acre by ground or in 10 gallons of water per
acre by air.
(broccoli)
[SLN]
5-11
(75X WP)
SLN - Use limited to CA.
Preemergence. Broadcast or band application.
Soil treatment. Apply preplant incorporated at
seeding. Apply in 20 gallons of water per acre by
ground or in 10 gallons of water per acre by air.
Issued: 5-28-86
1-078701-3
106
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Site.
Formulation
(Ib ».
EPA Co»pendiu» of Acceptable Uses
DIMETHYL TETRACHLOROTEREPHTHALATE
Tolerance. Use. Limitations
Broccolj (Chinese)
(tight beading
varieties)
Chinese Cabbage
(tight beading
varieties)
[SLN]
4.5-10.5
(75% WP)
Brussels Sprouts
Cabbage
Cantaloupe
1.0 pp»
Do not graze treated areas or feed plant parts to
livestock.
General Information; Do not enter treated area
until spray residue bas dried.
SLN - Use United to CA.
Preenergence. Broadcast. For control of annual
grasses and broadleaf weeds. Apply in a minimum
20 gallons of water per acre by ground or in a nin-
imun 10 gallons of water per acre by air at plant-
ing. Make 1 application per crop per growing sea-
son.
See Broccoli cluster.
See Broccoli cluster.
1.0 ppn
5-11 Preemergence. Broadcast or band application.
(2%, 2.28%, 2.41%, Soil treatment. Apply 4 to 6 weeks after seeding
2.5%, 3.85%, or at transplanting. For tbe wettable powder for-
4.16%, 5% G) nulation, apply in 20 gallons of water per acre by
(75% WP) ground or in 10 gallons of water per acre by air.
Do not incorporate into the soil.
5-11
(5%, 6% 6)
(75% WP)
[SLN]
5-6
(75% WP)
Cauliflower
Postemergence to seeded planting. Broadcast or
band application. Soil treatment. Apply when
plants have 4 to 5 true leaves. For the wettable
powder formulation, apply in 20 gallons of water
per acre by ground or in 10 gallons of water per
acre by air. Do not incorporate into the soil.
SLN - Use limited to NC.
Preplant incorporation. Broadcast.
to 50 gallons of water per acre.
See Broccoli cluster.
Apply in 25
Issued: 5-28-86
1-078701-4
107
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Site. Dosage and
Formulation
(Ib a.i./A)
Chinese Cabbage
(tight heading
varieties)
Collards
Kale
Mustard Greens
Turnip (greens)
Turnip (roots)
EPA CoapendiuB of Acceptable Uses
DIMETHYL TETRACHLOROTEREPHTHALATE
Tolerance. Use. Limitations
See Broccoli (Chinese) cluster.
2.0 ppm (collards, kale, turnips)
5.0 ppm (mustard greens, turnip (greens))
5-11
(2%, 2.28X, 2.41X,
2.5Z, 4.16X, 5%,
6X 6)
(75% WP)
Corn. Field
Corn. Sweet
8-11
(75X WP)
tSLN]
6-11
(75X WP)
Preemergence. Broadcast or band application.
Soil treatment. Apply preplant incorporated at
seeding or at transplanting. For the wettable
powder formulation, apply in 20 gallons of water
per acre by ground or in 10 gallons of water per
acre by air.
0.05 ppm (corn, grain (inc. field and pop) sweet
(K+CWHR))
0.4 ppm (corn, field, forage)
0.4 ppm (corn, field, fodder)
0.4 ppm (corn, pop, forage)
0.4 ppm (corn, pop, fodder)
0.4 ppm (corn, sweet, forage)
0.4 ppm (corn, sweet, fodder)
Preemergence. Broadcast or band application. Soil
treatment. Apply at planting. Do not incorporate
into the soil.
SLN - Use limited to NC and SC.
Posteroergence. Directed spray.- For control of
witchweed. Apply to corn interplanted to beans
(field, snap), southern peas, or soybeans. Apply
to corn 18 inches or taller in 20 to 30 gallons of
water per acre. Use drop nozzles between rows.
Issued: 5-28-86
1-018701-5
-------
Site.
fnH
Formulation
(Ib a.i./A)
Cotton
5-11
(75X WP)
Cress. Upland
[SLN]
5-11
(75X WP)
Cucumber
Eggplant
Peppers
EPA Compendia* of Acceptable Uses
DIMETHYL TETRACHLOROTEREPHTHALATE
Tolerance. Use. Limitations
0.2 pp» (cotton, seed)
45 day preharvest interval.
Preenergence. Broadcast. Apply preplant incorpo-
rated at seeding or at layby in 20 gallons of
water per acre by ground or in 10 gallons of water
per acre by air. Use the lower dosages for layby
application and the higher dosage for irrigated
areas. Do not apply after peak bloom.
5.0 ppm
SLN - Use United to NC and TN.
Preemergence. Broadcast. Soil treatment.
at seeding. May be preplant incorporated.
See Cantaloupe cluster.
1.0 ppm (eggplant)
2.0 ppm (peppers, pinentos)
Apply
5-11
(2%, 2.28%, 2.41X,
2.5%, 3.85X,
4.16X, 5X, 6X G)
(SOX, 75X WP)
Garlic
Onions
5-11
(21, 2.28X, 2.41X,
2.5X, 4.16X, 5X,
6X C)
(25X. SOX, 75X WP)
ffonevdew Melon
Issued: 5-28-86
Postemergence. Broadcast or band application.
Soil treatment. Apply at transplanting or at lay-
by. Layby applications may be made up to 4 to 6
weeks after transplanting. For wettable powder for-
mulations, apply in 20 gallons of water per acre
by ground or in 10 gallons of water by air. Do
not apply to seeded plants until plants are 4 to 6
inches tall.
1.0 ppm
Do not graze treated areas or feed plant parts to
livestock.
General Information: In sandy loam soils a maxi-
mum preemergence rate of 8 pounds active ingredi-
ent per acre is recommended.
Preemergence. Broadcast or band application.
Soil treatment. Apply at seeding or at transplant-
ing. For wettable powder formulations, apply in
20 gallons of water per acre by ground or in 10
gallons of water per acre by air. Do not preplant
incorporate.
OR
Layby application. Apply up to 14 weeks after
planting or transplanting.
See Cantaloupe cluster.
I-Q7A701-6
-------
Site. Dosage and
Formulation
(Ib a.i./A)
Horseradish
EPA Compendium of Acceptable Uses
DIMETHYL TETRACHLOROTEREPHTHALATE
Tolerance. Use. Limitations
2.0 ppm
8-11
(5X6)
[SLN]
5-11
(75X WP)
Lettuce (head)
Lettuce (leaf)
Preemergence. Broadcast or band application.
Soil treatment. Apply at planting. Do not pre-
plant incorporate.
See Collards cluster.
1.0 ppm (onions)
General Information; In sandy loam soils a maxi-
mum preemergence rate of 8 pounds active ingredi-
ent per acre is recommended.
SLN - Use limited to CA.
Preemergence. Broadcast or band application.
Soil treatment. Apply at seeding or at transplant-
ing. Apply in 20 gallons of water per acre by
ground or in 10 gallons of water per acre by air.
Do not preplant incorporate.
OR
Layby application. Apply up to 14 weeks after
planting or transplanting.
2.0 ppm
5-11 Preemergence. Broadcast or band application.
(2X, 2.28%, 2.41X, Soil treatment. For lettuce (head), make 1 appli-
2.5X, 3.85X,
4.16X, 5%, 6X G)
(75X WP)
Hung Beans
Mustard Greens
Oniong
Peppers
cation no later than 3 weeks after emergence.
OR
Postemergence. Broadcast or band application.
Soil treatment. For lettuce (leaf), make 1 appli-
cation no later than 3 weeks after emergence.
See Beans (dry, field, snap) cluster.
See Collards cluster.
See Garlic cluster.
See Eggplant cluster.
Issued: 5-28-86
1-078701-7
110
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Site. Dosage
Formulatiop
(Ib a.i./A)
EPA Compendium of Acceptable Uses
DIMETHYL TETRACHLOROTEREPHTHALATE
Tolerance. Use. Limitations
Potato (whole or cut
pieces)
2.0 pp»
Do not graze treated areas or feed plant parts to
livestock.
general Information: Initial sprinkler irrigation
should not exceed 1 inch. In the Pacific north-
west, under dry conditions, apply prior to the ini-
tial sprinkler irrigation. When using furrow irri-
gation in the Pacific northwest, shallow incorpo-
rate (less than 0.5 inch deep) while potato
sprouts are well below the soil surface. The 5
percent granular formulation is not recommended
for use in CA.
5-11 Preemergence. Broadcast or band application.
(2%, 2.28X, 2.41%, Soil treatment. Apply at planting, at drag-off or
2.5%, 4.16%, 5% G) at layby. Layby application can be made up to 9
(50%, 75% WP) weeks after planting. For the wettable powder for-
mulations, apply in 20 gallons of water per acre
by ground or in 10 gallons of water per acre by
air.
Radish (grown for
seed)
[SLN]
8-11
(75% WP)
Southern Peas
(black-eyed beans)
Soybeans
2
(10% G)
5-11
(4.16%, 5% 6)
(75% WP)
[MAI]
4-8
(24% 6)
(60% WP)
2.0 ppm (radish, roots)
15.0 ppm (radish, tops)
Do not graze in treated areas or feed plant refuse
to livestock. Do not allow seed screenings to be
used for feed.
SLN - Use limited to WA.
Preplant incorporated. Incorporate 3 to 4 inches
using a rotary tiller or double disk.
See Beans (dry, field, snap) cluster.
2.0 ppm
Do not graze treated areas or feed plant refuse,
vines or threshings to livestock.
Preplant incorporation. Band treatment.
incorporate 1 to 2 inches deep.
Shallow
Preemergence. Broadcast or band application.
Soil treatment. Apply at seeding in 20 gallons of
water per acre by ground or in 10 gallons of water
per acre by air.
Preemergence. Broadcast or band application.
Soil treatment. Apply after planting. Do not
plant to other crops within 4 months of treatment.
Formulated with linuron.
Issued: 5-28-86
1-078701-8
111
-------
Site. Dosage and
Formulation
(Ib a.i./A)
Squash
Strawberry
EPA Compendium of Acceptable Uses
DIMETHYL TETRACHLOROTEREPHTHALATE
Tolerance. Use. Limitations
See Cantaloupe cluster.
2.0 ppm
5-11
(2%, 2.28%, 2.41X,
2.5%. 3.85%,
4.16%, 5%, 6% G)
(25%, 50%, 75% WP)
Sweet Potatoes
(yams)
5-11
(2%, 2.28%, 2.5%,
3.85%, 4.16%, 5%
G)
(25%, 50%, 75% WP)
Tomato
Preemergence. Broadcast or band application.
Soil treatment. Apply preplan! incorporated or at
planting. For the wettable powder formulations,
apply in 20 gallons of water per acre by ground or
in 10 gallons of water per acre by air.
OR
Postemergence. Broadcast or band application.
Soil treatment. Apply to established plantings in
the fall or early spring. Do not apply after
first bloom.
2.0 ppm
Postemergence. Broadcast or band application.
Soil treatment. Apply at transplanting. For the
•wettable powder formulations, apply in 20 gallons
of water per acre by ground or in 10 gallons of
water per acre by air.
OR
Layby application. May be made up to 6 weeks
after transplanting.
1.0 ppm
5-11 Postemergence. Broadcast. Soil treatment. Apply
(2%, 2.28%, 2.41%, 4 to 6 weeks after transplanting or when seeded
2.5%, 3.85%, plants are 4 to 6 inches tall. For the wettable
4.16%, 5%, 6% G) powder formulation, apply in 20 gallons of water
(25%, 75% WP) per acre by ground or in 10 gallons of water per
acre by air.
Turnip (greens)
Turnip (roots)
"Watermelon
See Collards cluster.
See Collards cluster.
See Cantaloupe cluster.
Issued: 5-28-86
1-078701-9
112
-------
EPA Compendium of Acceptable Uses
DIMETHYL TETRACHLOROTEREPHTHALATE
Site. PQSaff» «nH Tolerance. Use. Limitations
(Ib
TERRESTRIAL NONFOOD CROP
(Ornamental Plants and Forest Trees)
Abelia
Arborvitae Do not graze or feed forage or plant refuse from
Asfr treated areas to livestock or poultry.
Austrian Pine General Information: Do not apply to soils to be
Azalea planted with seed the same season. For the wetta-
Barberry ble powder formulations, apply in 8 to 10 gallons
Birch of water per 5,000 square feet.
Blue Spruce
Border Forsvthia
Boston Ivy
Boxwood
California Privet
Camellia
Chestnut
Cotoneaster
Cottonwood
Creeping Juniper
Cuphea
Cypress
Deutzia
Dogwood
Dwarf Forsvthia
Elaeagnus
Elm
English Ivy
Euonvmus
Flowering Crabapple
Forsvthia
Ground-Hemlock
Gum
Hawthorn
Heath
Holly
Honeysuckle
Hybrid Tea Roses
Hydrangea
Japanese Andromeda
Japanese Barberry
Japanese Privet
Japanese Yew
Juniper
Lantana
Liaustrua
Lilac
Loblolly Pine
Issued: 5-28-86 1-078701-10
113
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EPA Compendium of Acceptable Uses
DIMETHYL TETRACHLOROTEREPHTHALATE
Site. Dosage and Tolerance. Use. Limitation^
formulation
(Ib a.i./A)
Abelia cluster (continued)
Locust
Magnolia
Maple
Mentor Barberry
Mock-Orange
Mountain-Laurel
Multiflora Rose
Oak
Pachysandra
Paxistima
Pine
Pittosporum
Podocarpus
Ponderosa Pine
Poplar
Redbud
Red Pine
Rhododendron
Rose
Russian Olive
Scotch Pine
Shore Pine
Spirea
Spruce
Sycamore
Tree Peony
Tuliptree
Varigated Privet
Viburnum
Walnut
Weigela
White Spruce
Willow
Wormwood
Yellow Pine
lew
1.0-1.3 Ib a.i./ Postemergence. Broadcast or band application.
5,000 sq.ft Soil treatment. Apply to new beds at transplant-
(1.27%, 2%, 2.28%, ing and to established plantings in the fall or
2.3%, 2.41%, 2.5%, early spring. Apply one-half of the product in 1
3.47%, 3.85%, direction and the other half at right angles to
4.16%, 5%, 6%, the first application.
6.14%, 6.9% 6)
(25%, 50%, 75% WP)
Issued: 5-28-86 1-078701-11
-------
EPA Compendium of Acceptable Uses
DIMETHYL TETRACHLOROTEREPHTHALATE
Site. Pocaff« rmi yoyafance. D«c. Limitations
Formulation
(Ib a.i./A)
Abe Ha cluster (continued)
0.9-1.3 Ib a.i./ Postemergence. Broadcast or band application.
5,000 sq.ft Soil treatment. For newly set out plants, apply
(2.41X, 2.5X, 4.6%, at lining-out in the late fall or early spring.
5X, 6.86X 6) For established plantings, apply after cultivation
(SOX, 7SX VP) to remove existing weeds. A late summer applica-
(54.9X F1C) tion will control fall-germinating weeds.
[MAI] Postemergence. Broadcast. Soil treatment.
1.3 Ib a.i./5,000 Formulated with carbaryl.
sq.ft
(1.27X G)
African Violet
Ageratum General Information; Do not apply to soils to be
AJuga planted with seed the same season. Do not apply
Alyssuai to bugleweed, button pink, carnations, geum, ger-
Aster mander, mesembryanthemum, pansies, phlox, sweet
Baby's Breath william, or telanthera.
BelIflower
Bleeding Heart
Bloodleaf
Blue Bedder Salvia
Bugloss
Candle Larkspur
Candytuft
Cape Marigold
Chrysanthemum
Cinquefoil
Coleus
Columbine
Coneflower
Coral Bells
Coreopsis
Cosmos
Creeping Thyme
Dahlias
Daisies
Evening Primrose
Fernleaf Yarrow
Feverfev
Foraet-Me-Not
Four-0'Clock
Foxglove
Gaillardia
Geranium
Gladiolus
Gold-Dust
Golden Marguerite
Issued: 5-28-86 1-078701-12
115
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EPA Compendium of Acceptable Uses
DIMETHYL TETRACHLOROTEREPHTHALATE
Site. Dosage and Tolerance. Use. Limitations
Formulation
(Ib a.i./A)
African Violet cluster (continued)
Goldentuft
Iris
Larkspur
Lavender Cotton
Lilies
Lupines
Marigold
Morningglory
Mourning Bride
Mourning Pink
Nasturtium
Orpine
Peonies
Petunias
Purple Coneflower
Rose Moss
Salvia
Scabiosa
Scarlet Sage
Snapdragon
Spiderwort
Stonecrop
Strawflower
Sundrops
Sunflower
Sweet Pea
Torch Lily
Verbena
Violets
Wallflower
Yarrow
Zinnia
1.0-1.3 Ib a.i./ Postemergence. Broadcast or band application.
5,000 sq.ft Soil treatment. Apply to new beds at transplant-
(1.27%, 2X, 2.28X, ing and to established plants in the fall or early
2.3X, 2.41X, 2.5X, spring. Apply onehalf of the product in 1 direc-
3.47X, 3.85X, tion and the other half at right angles to the
4.16X, 4.6X, 4.8X, first application. For the wettable powder formu-
5%, 6X, 6.14X, lations, apply in 8 to 10 gallons of water per
6.86X, 6.9X G) 5.000 square feet.
(25X, SOX, 75X HP)
[MAI] Postemergence. Broadcast. Soil treatment.
1.3 Ib a.i.75,000 Formulated with carbaryl.
sq.ft
(1.27X 6)
Issued: 5-28-86 1-078701-13
116
-------
Site.
fnH
Formulatipp
(Ib a.i./A)
Athletic Field/Turf
1.2 Ib a. i. /5.000
sq.ft
(6.9X G)
Bermudagrass (fro*
sod)
Zoysia Grass (from
sod)
1.3 Ib a. i. 75,000
sq.ft
(2.5X G)
English Ivy (ground
cover)
Ivy (ground cover)
Pachvsandra (ground
cover)
1.0-1.2 Ib a.i./
5,000 sq.ft
EPA Compendium of Acceptable Uses
DIMETHYL TETRACHLOROTEREPHTHALATE
. Dse. Limitations
Broadcast. Apply in the early spring before weed
germination.
General Information; These grasses are derived
from sod only, to be used as sprigs or plugs.
Broadcast. Apply at sod laying before the first
watering.
Postemergence. Broadcast. Soil treatment. Apply
in the late fall or early spring before weed ger-
(2.5X, 4.6X, 5X G) oination. Do not disturb soil after treatment.
An additional treatment may be made at the same
rate after 3 months.
Golf Fairvavs/Golf
Greens
General Information: If spring seeding is neces-
sary, wait 60 days after application to seed. Do
not use on bentgrass golf greens.
1.2 Ib a.i./5.000
sq.ft
Broadcast. Apply in the early spring before weed
germination. Apply half the product in 1 direc-
(2X, 2.87X, 6.9X G) tion and the other half at right angles to the
first application. A second application may be
made in the late summer or early fall.
Issued: 5-28-86
1-078701-14
117
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Site. Dosage and
Formulation
(It a.i./A)
Ornamental Lawns
EPA Compendium of Acceptable Uses
DIMETHYL TETRACHLOROTEREPHTHALATE
Tolerance. Use. Limitations
General Information: This site includes the fol-
lowing lawn grasses: alta fescue, bahiagrass (pen-
socola), carpetgrass, centipedegrass, fescue, Ken-
tucky bluegrass (merion), nixed blue-fescue, rye-
grass, and St. Augustinegrass (bitter blue),
(floratine). Use the lower dosages on sandy soils
and the higher dosages on heavy soils. Do not ap-
ply to Cohancey or Toronto bents, or to dichondra.
Do not apply to wet grass. Do not now lawns for
24 hours after treatment. When reseeding is neces-
sary, a delay of 60 days after treatment is recom-
mended. On newly spring-seeded lawns, do not ap-
ply until after the third mowing. Do not rake or
disturb soil after application. Apply before tem-
peratures reach 70 F (21.1 C) to 75 F (23.9 C) for
3 consecutive days. Apply on calm days to avoid
wind drift.
0.9-1.4 Ib a.i./
5,000 sq.ft
(1.15%, 1.25%,
1.27%, 1.5%,
1.72%, 2X, 2.28X,
2.3%, 2.31X, 2.5X,
2.87%, 2.9%,
3.28%, 3.47%,
3.85%, 4.16%,
4.4%, 4.6%, 4.87%,
5%, 5.75%, 6.14%,
6.3%, 6.86%, 6.9%,
7% G)
(25%, 50%, 75% WP)
(54.9% F1C)
(6% SC/L)
0.69 Ib a.i./
5,000 sq.ft.
(2.3% 6)
0.9-1.3 Ib a.i./
5,000 sq.ft
(3%, 4.16% G)
(50%, 75% WP)
(54.9% F1C)
Broadcast. Apply to newly seeded and established
lawns in early spring. Apply half the product in
1 direction and the other half at right angles to
the first application. A second application at
half the regular dosage may be made in late summer
or early fall. May be applied in 5 to 20 gallons
of water per 5,000 square feet.
Broadcast. For control of crabgrass. Apply in
late winter or early spring. Apply the second
application at right angles to the first applica-
tion.
Broadcast. For control of crabgrass on newly seed-
ed lawns. Apply in April, May, or June in at
least 5 to 10 gallons of water per 5,000 square
feet to new grass seedlings 1 to 2 inches tall.
Issued: 5-28-86
1-078701-15
118
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Site. Dosage
Formulation
(Ib a.i./A)
EPA Compendium of Acceptable Uses
DIMETHYL TETRACHLOROTEREPHTHALATE
Tolerance. Use. Limitations
Ornamental Lawns (continued)
1.4-1.8 Ib a.i./
5.000 sq.ft
(3%, 4.5%, 5% «)
(SOX, 75% WP)
(54.91 F1C)
(6% SC/L)
0.9-1.7 Ib a.i./
5.000 sq.ft
(5.5% 6)
1.1-1.4 Ib a.i./
5,000 sq.ft
(SOX WP)
(54.9% F1C)
0.9-1.4 Ib a.i./
5,000 sq.ft
(75% WP)
(54.9% F1C)
1 Ib a.i./5,000
sq.ft
(5% G)
1.2-2.0 Ib a.i./
5,000 sq.ft
(4.8%, 4.95%,
6.86% G)
(75% WP)
(6% SC/L)
[SLN]
1.8 Ib a.i./5,000
sq.ft
(3% G)
Broadcast. For control of annual bluegrass. In
the northern United States apply in aid-August or
September, in the southern United States earlier
treatments are required. Nay be applied following
an early spring treatment for crabgrass. May be
applied in 20 gallons of water per 5,000 square
feet.
Broadcast. For control of large and smooth crab-
grass. Apply January 1 through April 30. Do not
apply to newly seeded lawns.
Broadcast. For control of emerged slender speed-
well. Apply in at least 5 to 10 gallons of water
per 5,000 square feet in the spring or when temper-
atures are between 65 F (18.3 C) and 90 F (32.2
C). A second application may be made 14 days af-
ter the first application.
Broadcast. For control of prostrate and spotted
spurgg. Apply in mid-April and repeat application
in 6 to 8 weeks. Apply in at least 5 to 10 gal-
lons of water per 5,000 square feet.
Spot treatment. Apply in the late fall or early
spring before annual weeds germinate. Reseeding
of established lawns should not be done for at
least 6 months after treatment.
For Professional Use Only.
Broadcast. Apply in the spring before weed seeds
germinate. Delay application to newly seeded
lawns until greening of sprouted lawn grasses ap-
pear. At least 0.5 inch of irrigation or sprink-
ler water is needed within a week of application.
May be applied in 10 to 20 gallons of water per
5,000 square feet.
SLN - Use limited to OR and WA.
Broadcast. For control of emerged slender speed-
well. Apply in at least 5 to 10 gallons of water
per 5,000 square feet in the spring or when temper-
atures are between 65 F (18.3 C) and 90 F (32.2
C). A second application may be made 14 days af-
ter the first application.
Issued: 5-28-86
1-078701-16
11 Q
-------
EPA Compendium of Acceptable Uses
DIMETHYL TETRACHLOROTEREPHTHALATE
Site. Dosage and Tolerance. Use. Limitations
Formulation
(Ib a.i./A)
Ornamental Lawns (continued)
[MAI] Broadcast. Apply to new and established lawns in
1.3-1.9 Ib a.i./ late winter or early spring and again in late sum-
5,000 sq.ft ner or early fall.
(1.271 6) Formulated with carbaryl.
[MAI] Broadcast. Apply half the product in 1 direction
1.2 Ib a.i./5.000 and the other half at right angles to the first ap-
sq.ft plication. Repeat application in 4 weeks. Hater
(2.87X, 5.7X 6) lawn thoroughly 1 day before application. Do not
water or BOW lawn for 24 hours after application.
Do not apply when air temperatures are 85 F (29.4
C) or above. Do not use on St. Augustinegrass,
Tifgreen and other fine-bladed bermudagrasses,
bentgrasses, cutgrasses, or dichondras.
Formulated with one or a combination of: DSMA;
2,4-D, N-oleyl-1,3-propylenediamine salt; or 2-(2-
nethyl-4-chlorophenoxy)propionic acid, dimethyl-
amine salt.
Stocks
General Information: Do not enter treated area
until spray residue has dried.
[SLN] SLN - Use limited to Santa Barbara County, CA.
10.5 Preemergence. Broadcast. For control of pigweed.
(75% WP) Apply in 20 gallons of water per acre after plant-
ing but before crop emerges. Make 1 application
per crop per growing season.
AERIAL AND TANK MIX APPLICATIONS
Aerial Application
— Refer to
TERRESTRIAL FOOD CROP
(Agricultural Crops)
Beans (dry, field, snap); Broccoli; Broccoli (Chi-
nese) (tight heading varieties); Brussels Sprouts;
Cabbage; Cantaloupe; Cauliflower; Chinese Cabbage
(tight heading varieties); Collards; Cotton;
Cress, Upland; Cucumber; Eggplant; Garlic; Honey-
dew Melon; Kale; Leeks; Mung Beans; Mustard
Greens; Onions; Peppers; Potato (whole or cut
pieces); Southern Peas (black-eyed beans); Soy-
beans; Squash; Strawberry; Sweet Potatoes (yams);
Tomato; Turnip (greens); Turnip (roots); Water-
Be Ion
Issued: 5-28-86 1-078701-17
120
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EPA Compendium of Acceptable Uses
DIMETHYL TETRACHLOROTEREPRTHALATE
Site. Dosage and Tolerance. U»e. Limitations
Fornulatjop
(Ib a.i./A)
Aerial Application (continued)
TERRESTRIAL NONFOOD CROP
(Ornamental Plants and Forest Treei)
Athletic Field/Turf
Issued: 5-28-86 1-078701-18
121
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EPA Conpendiua of Acceptable Uses
DIMETHYL TETRACHLOROTEREPHTHALATE
Listing of Registered Pesticide Products by Formulation
501 formulation intermediate
dimethyl tetrachloroterephthalate (078701)
050534-00025
90X formulation intermediate
dimethyl tetrachloroterephthalate (078701)
050534-00113
1.15X granular
dimethyl tetrachloroterephthalate (078701)
005298-00008 011684-00002
1.25% granular
dimethyl tetrachloroterephthalate (078701)
001990-00147 008952-00001
1.27% granular
dimethyl tetrachloroterephthalate (078701)
042057-00084
dimethyl tetrachloroterephthalate (078701) plus carbaryl (056801)
015099-00001
1. 5X granular
dimethyl tetrachloroterephthalate (078701)
005298-00007
1.72% granular
dimethyl tetrachloroterephthalate (078701)
058649-00001
2T granular
dimethyl tetrachloroterephthalate (078701)
007401-00024 007401-00076 007401-00140 007401-00385
010107-00004
2.28% granular
dimethyl tetrachloroterephthalate (0787001)
007764-00003 033108-00010 033108-00012 033108-00013
2.3* granular
dimethyl tetrachloroterephthalate (078701)
000072-00508 000557-00655 000557-01691 000557-01782
000961-00205
2.31X granular
dimethyl tetrachloroterephthalate (078701)
003442-00702 007001-00270
2.41X granular
dimethyl tetrachloroterephthalate (078701)
007401-00027
Issued: 5-28-86 1-078701-19
122
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EPA Compendium of Acceptable Uses
DIMETHYL TETRACHLOROTEREPHTHALATE
Listing of Registered Pesticide Products by Formulation (continued)
001386-00477
003772-00028
050534-00017
2.5% »rami)ar
dimethyl tetrachloroterephthalate (078701)
000728-00069 000746-00109 001381-00116
002217-00617 002393-00176 003442-00760
008814-00001 010107-00086 033955-00474
2.87* granular
dimethyl tetrachloroterephthalate (078701)
00849-00014 009198-00001
dimethyl tetrachloroterephthalate (078701), disodium methanearsonate
(013802), 2,4-dichlorophenoxyacetic acid, N-oleyl-1,3-propylenediamine
salt (030029) plus 2-(2-methyl-4-chlorophenoxy)pr.^ionic acid, dimeth-
ylamine salt (031519)
003234-00029
2.9* granular
dimethyl tetrachloroterephthalate (078701)
000228-00157 000961-00243 008378-00009
3X granular
dimethyl tetrachloroterephthalate (078701)
000802-00503
(000820-00503)
OR800075 WA800066
3.281 granular
dimethyl tetrachloroterephthalate (078701)
003234-00028 024232-00004
3.47X granular
dimethyl tetrachloroterephthalate (078701)
042057-00083
3.85% granular
dimethyl tetrachloroterephthalate (078701)
000407-00408 000557-01758 000557-01822
004185-00319 004185-00374
4.16X granular
dimethyl tetrachloroterephthalate (078701)
000468-00009 000468-00019 000468-00021
023486-00014 023486-00029 023486-00032
4.4% granular
dimethyl tetrachloroterephthalate (078701)
000538-00109
fc.St granular
dimethyl tetrachloroterephthalate (078701)
001159-00165
004067-00004
000471-00014
Issued: 5-28-86
1-078701-20
123
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EPA Conpendiua of Acceptable Uses
DIMETHYL TETRACHLOROTEREPHTHALATE
Listing of Registered Pesticide Products by Formulation (continued)
4.6X granular
dimethyl tetrachloroterephthalate (078701)
000557-01733 000961-00225 002290-00033
032802-00006
4.8X granular
010404-00049
dimethyl tetrachloroterephthalate (078701)
000572-00193
4.87% granular
dimethyl tetrachloroterephthalate (078701)
000961-00310
4.95% granular
dimethyl tetrachloroterephthalate (078701)
008378-00013
5% granular
dimethyl tetrachloroterephthalate (078701)
000004-00300 000016-00042 000072-00478
000407-00284
000538-00128
000802-00441
001159-00154
002125-00049
005298-00016
007001-00275
008590-00482
033108-00004
000407-00317
000572-00147
000829-00165
001386-00610
002939-00013
005348-00012
007001-00321
010107-00082
033108-00007
CA800178
000407-00416
000572-00282
000961-00273
001990-00362
003442-00808
005815-00035
008590-00260
010404-00048
042057-00103
000239-
000471-
000655-
000961-
002124-
003442-
005887-
008590-
010051-
050534-
02456
00023
00628
00278
00759
00810
00097
00377
00031
00003
dimethyl tetrachloroterephthalate (078701), dimethyl phosphate of alpha-
methyl-benzyl 3-hydroxy-cis-crotonate (058801) plus xylene (086802)
045180-00016*
*jacket currently unavailable for review
5.5t granular
dimethyl tetrachloroterephthalate (078701)
009198-00024
5.7% granular
dimethyl tetrachloroterephthalate (078701), 2,4-dichlorophenoxyacetic
acid (030001) plus 2-(2-methyl-4-chlorophenoxy)propionic acid (031501)
000538-00099
5.75% granular
dimethyl tetrachloroterephthalate (078701)
000538-00106 002491-00139
Issued: 5-28-86
1-078701-21
124
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EPA Compendium of Acceptable Uses
DIMETHYL TETRACHLOROTEREPHTHALATE
Listing of Registered Pesticide Products by Formulation (continued)
6% granular
dimethyl tetrachloroterephtbalate (078701)
005535-00102
6.14X granular
dimethyl tetrachloroterephthalate (078701)
008590-00247
6.3t granular
dimethyl tetrachloroterephthalate (078701)
000538-00087 000538-00107
6.86% granular
dimethyltetrachloroterephthalate (078701)
000572-00237 008590-00578 033625-00001
6.9% granular
dimethyl tetrachloroterephthalate (078701)
000264-00249 000557-01971
7% granular
dimethyl tetrachloroterephthalate (078701)
003442-00559
10% granular
dimethyl tetrachloroterephthalate (078701)
000228-00099
24% granular
dimethyl tetrachloroterephthalate (078701) plus linuron (035506)
050534-00030
25% wettable powder
dimethyl tetrachloroterephthalate (078701)
000228-00222
50% vettable powder
dimethyl tetrachloroterephthalate (078701)
000004-00297 023486-00048
60% wettable powdef
dimethyl tetrachloroterephthalate (078701) plus linuron (035506)
050534-00026
75% wettahle powder
dimethyl tetrachloroterephthalate (078701)
000004-00296 000407-00338 001381-00078 002749-00232
007765-00017 033955-00509 050534-00001 050534-00020
( ) TN810022
Issued: 5-28-86 I-$£%701-22
125
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EPA Compendium of Acceptable Uses
DIMETHYL TETRACHLOROTEREPHTHALATE
Listing of Registered Pesticide Products by Formulation (continued)
75% wettable powder (continued)
(050534-00001)
(050534-00020)
CA800178 CA860043 NC780025 NC810008
HC810030 SC780015 TN870009 WAS20004
IN780010 NV810006
54.9% flovable concentrate
dimethyl tetrachloroterephthalate (078701)
050534-00010
6% soluble concentrate/liquid
dimethyl tetrachloroterephthalate (078701)
001769-00246
State Label Registrations
AZ Reg. No.
010583-09397
CA Reg. No.
011093-07368 011149-04670 011204-04104
CO Reg. No.
000677-03977
ID Reg. No.
000677-03978
KM Reg. No.
000677-03980 010583-03256
NV Reg. No.
000677-03979
OK Reg. No.
000677-03981
OR Reg. No.
000677-03982
TX Reg. No.
010583-08650
UT Reg. No.
000677-03983
WA Reg. No.
000677-03984
Tssued: 5-28-86
IH
01-23
-------
Listing of
Chemical
Chemical
Code
056801
058801
030001
030029
013802
035506
031501
031519
086802
EPA Compendium of Acceptable Uses
DIMETHYL TETRACHLOROTEREPHTHALATE
Appendix A-1
Active Ingredient(c) Found in Combination with the Report
Common H
(source)
carbaryl
crotoxphos (ISO)
2.4-D
2,4-D, N-oleyl-1,3-propylenedi-
anine salt
DSHA
1inuron
necoprop (ISO)
2-(2-methyl-4-chlorophenoxy)
propionic acid, dimethylamine
salt
xylene
EPA Acceptable
Don/Chemical
dimethyl phosphate of alpha-
methyl-benzyl 3-hydroxy-cis-
crotonate.
2,4-d ichlorophenoxyacetic
acid
2,4-d ichlorophenoxyacetic
acid, N-oleyl-1,3-propylene-
diamine salt
disodium methanearsonate
2-(2-methyl-4-chloro-phenoxy)-
propionic acid
— Use Common Name
Issued: 5-28-86
127
-------
APPENDIX IV
BIBLIOGRAPHY APPENDICES
128
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BIBGUIDE-1
GUIDE TO USE OF THIS BIBLIOGRAPHY
1. CONTENT OF 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." 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, number. This number is unique to the citation, and
should be used at any time specific reference Is required.
It Is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(A) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary Identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID) , each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
129
-------
BIBGUIDE-2
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission.
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
130
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the DCPA Standard
MRID CITATION
00010026 Manning, P.B.; Olney, C.E.; Quinn, J.G.; et al. (1963) Direct gas
chromatographic method for herbicide residues suitable for elec-
tron-capture detection. Pesticide Research Bulletin 3(2):6-8.
(Also in unpublished submission received Sep 1963 under 464-
367; submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:
101380-A)
00017975 Burnside, O.C. (1977) Abstract for the 1977 North Central Weed Con-
trol Conference Research Report: Selective Control of Weeds in
Corn: Test No. 11488. (Unpublished study received Oct 20, 1978
under 100-583; prepared by Univ. of Nebraska, Agricultural Ex-
periment Station, submitted by Ciba-Geigy Corp., Greensboro,
N.C.; CDL:235353-BK)
00018299 Stallard, D.E. (1970) Residue Analyses and Procedure. (Unpublished
study received Nov 12, 1970 under unknown admin, no.; submitted
by Diamond Shamrock Agricultural Chemicals, Cleveland, Ohio;
CDL:123816-E)
00018842 Atkins, E.L., Jr.; Anderson, L.D.; Greywood, E.A. (1969) Effect of
Pesticides on Apiculture: Project No. 1499; Research Report CF-
7501. (Unpublished study received May 8, 1971 under 1F1174;
prepared by Univ. of California—Riverside, Dept. of Entomology,
submitted by Ciba Agrochemical Co., Summit, N.J.; CDL:090973-B)
00033087 Manning, P.B.; Kerr, T.W.; Olney, C.E.; et al. (1964) Residue
Study. (Unpublished study including published data, received
Jan 14, 1965 under 100-471; prepared in cooperation with Univ.
of Rhode Island, Agricultural Experiment Station and Gaspro,
Ltd., submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:
000459-F)
00038919 Gutenmann, W.H.; Lisk, D.J. (1966) Metabolism of Daconil and Dac-
thal pesticides in lactating cows. Journal of Dairy Science 49
(10):1272-1276. (Also in unpublished submission received Feb
25, 1976 under 6F1749; submitted by Diamond Shamrock Agricultur-
al Chemicals, Cleveland, Ohio; CDL:096457-K>
00057629 Reno, F.E.; Stanovick, R. (1974) Final Report: Meat and Milk Resi-
due Study in Dairy Cows: Project No. 200-223. (Unpublished
study received on unknown date under 3F1417; prepared by Envi-
ronmental Sciences Corp., submitted by Diamond Shamrock Agricul-
tural Chemicals, Cleveland, Ohio; CDL:093787-C)
131
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the DCPA Standard
MRID CITATION
00058377 Diamond Shamrock Agricultural Chemicals (1973) Residue Studies of
Dacthal in Various Crops. (Compilation; unpublished study re-
ceived Jun 29, 1973 under 3F1417; CDL:093787-D)
0005&378 Szalkowski, M.B. (1973) Evaluation of the Potential for Dacthal
and Its Metabolites to Accumulate in Chicken Eggs and Tissues
during 30 Days of Dietary Exposure. (Unpublished study
received Jun 29, 1973 under 3F1417; submitted by Diamond
Shamrock Agricultural Chemicals, Cleveland, Ohio; CDL:093787-E)
00072099 Diamond Shamrock Corporation (1968) Hexachlorobenzene Residue Data.
(Compilation; unpublished study received Dec 10, 1968 under
9F0780; CDL:091340-C)
00083584 Hazleton, L.W.; Dieterich, W.H. (1963) Final Report: Two-year
Dietary Feeding—Dogs. (Unpublished study received Dec 15, 1963
under PP0411; prepared by Hazleton Laboratories, Inc., submitted
by Diamond Shamrock Agricultural Chemicals, Cleveland, Ohio;
CDL:090443-T)
00090259 Hazleton Laboratories (1963) Residue Data for Cabbage and Various
Other Crops Treated With Dacthal. (Compilation; unpublished
study received Dec 18, 1963 under PP0411; CDL:090445-A)
00100775 Kouri, R.; Parmar, A.; Kuzava, J.; et al. (1977) Activity of DTX-
77-0004 in the Dominant Lethal Assay in Rodents for Mutagen-
icity: Project No. T1077. Final rept. (Unpublished study re-
ceived May 12, 1982 under 677-290; prepared by Microbiological
Assoc., submitted by Diamond Shamrock Agricultural Chemi-
cals, Cleveland, OH; CDL:247439-C)
001l4o31 Diamond Shamrock Agricultural Chemicals (1973) Residue Data:
Dacthal. (Compilation; unpublished study received May 10,
1973 under 677-166; CDL:004224-B)
00114642 Diamond Alkali Co. (1967) Results of Tests on the Amount of Residue
Remaining: Dacthal. (Compilation; unpublished study received
Jan 9, 1968 under 8F0640; CDL:091112-B)
00114643 Diamond Alkali Co. (1964) Study: Dacthal Residue on Selected
Crops. (Compilation; unpublished study received on unknown
date under PP0411; CDL:092698-A)
132
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the DCPA Standard
MRID CITATION
00114644 Diamond Alkali Co. (1967) Residues of Dacthal in Cottonseed.
(Compilation; unpublished study received Dec 28, 1967 under
8F0640; CDL:092934-A)
00114648 Szalkowski, M. (1975) The Effect of Light, Temperature, and pH on
the Hydrolysis of Dacthal. (Unpublished study received Mar 23,
1976 under 3F1417; submitted by Diamond Shamrock Chemcial
Co., Cleveland, OH; CDL:095189-D)
00114654 Interregional Research Project No. 4 (1975) Results of Tests on the
Amount of Residues Remaing, Including a Description of the Ana-
lytical Methods Used: Dacthal. (Compilation; unpublished
study received Nov 21, 1975 under 6E1711; CDL:095363-A)
00114677 Limpel, L. (1962) Letter sent to Diamond Alkali Co. dated Sep 13,
1962; Radioautographic studies of HCB and Dacthal applied to
cotton plants. (Unpublished study received Nov 21, 1962 under
unknown admin, no.; prepared by Boyce Thompson Institute for
Plant Research, Inc., submitted by Diamond Shamrock Agricultural
Chemicals, Cleveland, OH; CDL:119453-A)
00114678 Diamond Shamrock Agricultural Chemicals (1962) Summary of Status of
Residue Data: Dacthal. (Compilation; unpublished study re-
ceived Nov 21, 1962 under 677-139; CDL:119455-A)
00114679 Stallard, D. (1961) Dacthal Herbicide Residue Studies on Tomatoes.
(Unpublished study received Dec 12, 1961 under unknown admin.
no.; submitted by Diamond Shamrock Aqricultural Chemicals,
Cleveland, OH; CDL:119456-A)
00114680 Diamond Shamrock Agricultural Chemicals (1961) Study: Dacthal
Residue on Selected Crops. (Compilation; unpublished study
received Oct 31, 1961 under unknown admin, no.; CDL:119457-A)
00114681 Diamond Shamrock Agricultural Chemicals (1962) Study: Dacthal
Residue on Selected Crops. (Compilation; unpublished study
received Dec 10, 1962 under unknown admin, no.; CDL:119459-A)
00121864 Diamond Shamrock Agricultural Chemicals (1981) The Results of
Tests on the Amount of DCPA Residues Remaining in or on Radish,
Including a Description of the Analytical Method Used. (Com-
pilation; unpublished study received Dec 17, 1982 under 677-166;
CDL:071286-A)
00123748 Priddle, W.; Stallard, D.; Skinner, W. (1964) Determination of
Residues of Dacthal Herbicide in Vegetables and Agronomic
Crops. (Unpublished study received Apr 10, 1973 under 3E1388;
prepared by Diamond Alkali Co., submitted by Interregional
Research Project No. 4, New Brunswick, NJ; CDL:093701-A)
133
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the DCPA standard
MRID CITATION
00130562 Jespersens Lab (1975) Efficacy of Daethai on Garlic. (Compila-
tion; unpublished study received Feb 5, 1981 under 667-166;
CDL:244287-A)
00150207 Auletta, C. (1984) Dermal Sensitization Study (Closed-patch Repeat-
ed Insult) in Guinea Pigs with Technical Dacthal: Report Number
5285-84. Unpublished study prepared by Bio/dynamics, Inc. 78
P-
00160685 Ford, W. (1986) A Teratology Study in Rats with Technical DCPA:
Document No. 712-5TX-85-0039-003: Report SDS-893. Unpublished
study prepared by SDS Biotech Corp. in cooperation with Argus
Research Laboratories, Inc. 194 p.
40098001 Mayer, F.; Ellersieck, M. (1986) Manual of Acute Toxicity: Inter-
pretation and Data Base 410 Chemicals and 66 Species of Fresh-
Water Animals. US Fish & Wildlife Service; Resource Publica-
tion (160):1-36.
40228401 Mayer, F. (1986) Acute toxicity handbook of chemicals to estuarine
organisms: EPA/600/X-86/231. Prepared by US EPA Environmental
Research Laboratory, Gulf Breeze, FL. 275 p.
40240801 Interregional Research Project No. 4 (1973) Petition for Tolerance
for Dacthal on Rutabagas. Unpublished compilation. 31 p.
40259001 Schuldt, P.; Burchfield, H.; Stallard, W.; et al. (1961) Colorimetric
determination of micro amounts of dimethyl terachloroterephthalate.
Contributions from Boyce Thompsonn Institute for Plant Research.,
Inc. (21):163-173
40259101 Limpel, E. (1961) Studies with Dacthal Herbicide, Tagged with C'14
and C'136, Applied to Field Grown Crops. Memorandum sent to
Diamond Alkali Company, Dec 4, 1961. 13 p.
40543001 U.S. Environmental Protection Agency (1984) Health Effects Assess-
ment for Hexachlorobenzene: EPA/54C/186-C17). Prepared by Syracuse
Research Corp., under EPA Contract 68-03-3112, for the Office
of Solid Waste and Emergency Response, Washington, DC. 43 p.
40543002 U.S. Environmental Protection Agency (1985) Health Effects Assess-
ment Document for Polychlorinated Dibenzo-p-Dioxines; Final
Report. EPA/600/8-84-C14F. Prepared by Environmental Criteria
and Assessment Office, Cinicinnati, OH., for the Office of Air
Quality Planning and Standards, Washington, DC. 631 p.
134
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APPENDIX V
FORMS APPENDICES
135
-------
OMB Approval No. 2070-0057
Expires 11/30/89
FIFHA SECTION 3(C)(2)(B) SUMMARY SHEET
f>A REGISTRATION NO.
A**UCANT-S NAME
DATE GUlOANCt DOCUMENT ISSUED
Wit* raptct to tht nquirwiwit to ubmit "|tnwic" dtti impend b* tht FIFRA action 3(CX2J(I) netic« comwitd * tht rtftr*iiM
Guid«nct Oocvm«tt I am resondint, in (fit foilovwnt mannor
O I. I onll wbrnit dm in t timrtv m«nn«r n »tstf tni fenowinf rtquirwntntt If fl>* tw prKtdurn I win u» rfmuf from (or art net
tpKifitd in) ttii Rtfinrttion Cuidtlifln or itit rVotoco'l conttinttf in flu Ktporti of EiDtrt Groupt to tht CAtmicfli Creoo. OECD
Chwnic«li TtRm« frognmrnt, I tncfoit ttit protocoli trtn I will »•:
,
ft *jrw(ntnt wrtfi ont or mort o(Atr r*f«irtmi untftf FIFRA
nouinmtna Trio nra. *n4 (Ay nquirtd prfltxod. will b< Mbmintd U EPA by:
3(C)(2](B)(ii) 10
(tit foHo«*m| d«tt
NAME OF OTM£R REGISTRANT
Ol I tncloa i complittd ~C*nrfic»«n of Antfflpi te Enttr Into tnAgrMmont with Otfior RtginrtmiforOrvtlopmtm o< Otti'wun
rw»KT to ttit following did rtquirimtna:
C<. I rtqutrt ffin YN irntrid nv» r*|iarnion ov dtfitini rfit foflowtA| itw (th« option • not iv>rl*6ii to t0pi«*mifor ntw products):
Ol
anc«««rJon of tfco rtfinmio* «t tf* »f»»J
REGISTRANT* AUTHOAlZZO RtfRUENTATIVf
IIQNATUftl
OATl
f/A
1 (10-tt
136
-------
OMB Approval No. 2070-0057
•Expires 11/30/89
anttoALL tovr**ml
CERTIFICATION OF ATTEMPT TO ENTtft
INTO AM AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1.1 am outy evthortttd to r«orft«nt the foftow»«fl firm(sl who are M/oject to th» require-
ments of • Notio* undtr FtFRA Section 3(c)l2)(ll contained in a Outdance Ooeum«it
to iwomit data eonoeminf the aetwe ingredient;
ACTIVf IWO"IO
-------
OMB Approval No. 2070-0057
Expires 11/30/89
PRODUCT SPECIFIC DATA REPORT
EPA Reg. NO.
Date
Registration Standard for
Registration
Guideline No.
5158.120
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
Name of Test
Identity of
ingredients
Statement of
composition
Discussion of
formation of
inqredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-
density, or
specific gravity
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
PH
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
MRID Numbers
Assigned
138
-------
OMB Approval No. 2070-0057
Expires 11/30/89
Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
S158.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
Stability
Oxidizing/reducing
reaction
Flaimiability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric break-
down voltaqe
Acute oral
toxicity^ rat
Acute dermal
toxicity, rabbit
Acute inhalation,
toxicity^ rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
MRID Numbers
Assigned
139
-------
OMB Approval No. 2070-0057
Expiration Date 11/30/89
GENERIC DATA EXEMPTION STATEMENT
EPA Product Registration Number:
Registrant's Name and Address: .
As an authorized representative of the registrant of the product identified
above, I certify that:
(1) I have read and am familiar with the terms of the Notice from EPA dated
concerning a requirement for submission of generic data on the
active ingredient named under FIFRA Section 3(c)(2)(B).
(2) My firm requests that EPA not suspend the registration of our product,
despite our lack of intent to submit the generic data in question, on the grounds
that the product contains the active ingredient solely as the result of the
incorporation into the product of another product which contains that active
ingredient, which is registered under FIFRA Section 3, and which is purchased by
us from another producer.
(3) An accurate Confidental Statement of Formula(CSF) for the above-identified
product is attached to this statement. That formula statement indicates, by
company name, registration number, and product name, the source of the subject
active ingredient in my firm's product, or
The CSF dated on file with EPA is complete, current and accurate and
contains the information requested on the current CSF Form No. 8570-4. The
registered source(s) of the above named active ingredient in my product(s) is/are
and their registration number (s) is/are .
(4) My firm will apply for an amendment to the registration prior to changing
the source of the active ingredient in our product to one that is not registered
and purchased.
(5) I understand, and agree on behalf of my firm, that if at any time any
portion of this Statement is"no longer true, or if my firm fails to comply with
the undertakings made in this Statement, my firm's product's registration may be
suspended under FIFRA Section 3(c)(2)(B).
(6) I further understand that if my firm is granted a generic data exemption
for the product, my firm relies on the efforts of other persons to provide the
Agency with the required generic data. If the registrant(s) who have committed
to generate and submit the required data fail to take appropriate steps to meet
requirements or are no longer in compliance with this Notice's data requirements,
the Agency will consider that both they and my firm are not in compliance and
will normally initiate proceedings to suspend the registrations of my firm's
product(s) and their product(s), unless my firm commits to submit and submits
the required data in the specified time frame. I understand that, in such cases,
the Agency generally will not grant a time extension for submitting the data.
Registrant's authorized representative:
(Signature)
Dated:
(Typed)
140
EPA Form 8570-27
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