Unit** Stetw
EnvironnMntsI ProMcth
Agency
OffiMof
Pwttefctat and Toxic SuiMtanew
WMhington DC 20460
Pwticktet
P/EPA
Guidance for the
Reregistration of
Pesticide Products
Containing METHOXYCHLOR
as the Active Ingredient
-------
OMB Control No. 2070-0057
Expires 11/89
GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
METHOXYCHLOR
AS THE ACTIVE INGREDIENT
CAS REGISTRY NO. 72-43-5
OPP Chemical Code 034001
EPA CASE NUMBER 0249
December, 1988
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
-------
TABLE OF CONTENTS
Page
I. INTRODUCTION 1
II. CHEMICAL COVERED BY THIS STANDARD 4
A. Description of Chemical 4
B. Use Profile . 5
C. Data Call-in Notices Issued 7
III. AGENCY FINDINGS 8
A. Summary 8
B. Health Effects Assessment 10
C. Environmental Characteristics and Effects . . 10
D. Tolerance Reassessment 11
IV. REGULATORY POSITION AND RATIONALE ........ 14
V. REQUIRED LABELING AND COMPLIANCE
DATES 18
VI. PRODUCTS SUBJECT TO THIS STANDARD 22
VII. REQUIREMENT FOR SUBMISSION OF GENERIC DATA . . . .24
A. What are generic data? 24
B. Who must submit generic data? 24
C. What generic data must be submitted? 25
D. How to comply with DCI requirements 25
E. Registrant Requests Regarding Data Requirements
and Agency Responses 28
F. Test Protocols and standards 28
G. Procedures for Requesting a Change in Test
Protocol 29
H. Procedures for Requesting Extensions of Time . 29
I. Data Format and Reporting Requirements .... 29
J. Existing Stocks Provision Upon Suspension or
Cancellation 30
VIII. REQUIREMENT FOR SUBMISSION OF PRODUCT SPECIFIC
DATA 30
IX. REQUIREMENT FOR SUBMISSION OF REVISED LABELING . . 31
X. INSTRUCTIONS FOR SUBMISSION 31
A. Manufacturing-Use Products (Sole Active) ... 32
B. Manufacturing-Use Products (Multiple Active) . 32
C. End-Use Products (Sole Active) 33
D. End-Use Products (Multiple Active) 33
E. Intrastate Products 34
-------
APPENDICES
Page
I. DATA APPENDICES 35
Guide to Tables 36
Table A 39
Table B 82
II. LABELING APPENDICES 88
Summary of Label Requirements and Table ...... 89
40 CFR 156.10 Labeling Requirements ........ 99
Physical/Chemical Hazards Labeling Statements . . .108
Storage Instructions 109
Pesticide Disposal Instructions . . . . 110
Container Disposal Instructions ... .111
III. BIBLIOGRAPHY APPENDICES 112
Guide to Bibliography 113
Bibliography 115
IV. FORMS APPENDICES 119
EPA Form 8580-1 FIFRA 3(c)(2)(B) Summary Sheet
EPA Form 8580-6 Certification of Attempt to Enter Into an
Agreement With Other Registrants for
Development of Data
EPA Form 8580-4 Product-Specific Data Report
EPA Form 8570-27 Generic Data Exemption Statement
ii
-------
GLOSSARY OF TERMS AND ABBREVIATIONS
ADI; Acceptable Daily Intake
a.i.: active ingredient
CAS: Chemical Abstract Services (number)
CSF: Confidential Statement of Formula
EEC: Estimated Environmental Concentration
EPA: The U.S. Environmental Protection Agency (Agency)
FIFRA: The Federal Insecticide, Fungicide, and Rodenticide
Act
LC5o: Median lethal concentration - a statistically
derived concentration of a substance that can be
expected to cause death in 50% of test animals,
expressed as weight or volume of test substance
per volume of air or water or per weight of feed
(e.g., mg/l or ppm).
LD50: Median lethal dose - a statistically derived single
dose that can be expected to cause death in 50% of
test animals when administered by the route
indicated, expressed as weight of substance per
unit weight of test animal (e.g., mg/kg).
LEL: Lowest Effect Level
MPI: Maximum Permissible Intake
MRID: Master Record Identification (number) - EPA's
system of tracking studies used in support of
registration.
NPDES: National Pollutant Discharge Elimination System
NOEL: No Observed Effect Level
OPP: The Office of Pesticide Programs of the U.S. EPA
PHI: Preharvest Interval
111
-------
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
-'-The scientific reviews and the EPA Use Index may be
obtained from the National Technical Information Service
(NTIS) as of April 1, 1988.
-------
provisions of this Registration Standard to end use products
if necessary to protect man and the environment.
EPA's reassessment results in the development of a
regulatory position, contained in this Registration Standard,
on the pesticide and each of its registered uses. See
Section IV - Regulatory Position and Rationale. Based on its
regulatory position, the Agency may prescribe a variety of
steps to be taken by registrants to maintain their
registrations in compliance with FIFRA. These steps may
include:
1. Submission of data in support of product
registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in
the issuance of a Notice of Intent to Cancel or a Notice of
Intent to Suspend (in the case of failure to submit data).
In addition, in cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154 to
examine in depth the risks and benefits of use of the
pesticide. If the Agency determines that the 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
and B 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 unreasonable adverse effects of a pesticide at any
time that they become aware of such information. Registrants
must notify the Agency of any information, including interim
or preliminary results of studies, if that information
suggests 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 the
products are registered under FIFRA.
-------
I. INTRODUCTION
II. CHEMICAL COVERED BY THIS STANDARD
A. Description of Chemical
The following chemical is covered by this Registration
Standard:
Common Name: Methoxychlor
Generic (Chemical) Name: 1,1,l-trichloro-2,2-bis(4-
methoxyphenyl) ethane
Chemical Family: Chlorinated hydrocarbon
Trade Names: Marlate, Prentox, and Methoxcide
Other Chemical Nomenclature: 1,1,l-trichloro-2,2-di(4-
methoxyphenyl)ethane;
l,l-(2,2,2-tri chloro-
ethylidene)bis[4-methoxy-
benzene]; 1,1,1-
trichloro-2,2-bis(p-
methoxyphenyl)ethane; 2,2-
bis)p-methoxyphenyl)-
1,1,1-trichloroethane
CAS Registry No.: 72-43-5
EPA Pesticide Chemical Code (Shaughnessy Number): 034001
Empirical Formula: Ci6H15cl3°2
Molecular Weight: 345.7
Chemical/Physical Characteristics:
Color: Data Gap
Physical State: Crystalline solid (Farm Chemicals,
1987)
Odor: Data Gap
Melting Point: 89 °C (Farm Chemicals, 1987)
Specific Gravity: Data Gap
Solubility: Very soluble in aromatic chlorinated, or
ketonic solvents, somewhat soluble in
paraffinic types; essentially insoluble
in water (Farm Chemicals, 1987)
Vapor Pressure: Data Gap
Flammability: Data Gap
pH: Data Gap
-------
B. Use Profile
Type of Pesticide: Insecticide/Acaricide
Year of Initial Registration: 1948
Registered
Uses:
TERRESTRIAL FOOD CROP: seed treatment only use
on barley, cotton, flax, lentils, lespedeza,
millet, mustard, oats, .okra, onion, rape, rice,
rye, safflower, sesame, small seed legumes,
sorghum, sugar beet, sunflower, swiss chard,
trefoil, and wheat; foliar application
(including seed treatment) use on alfalfa,
beans, beets, blueberry, broccoli, brussels
sprouts, cabbage, carrots, cauliflower, clover,
collards, corn (field and sweet), cowpeas,
cucumber, eggplant, endive, grass, kale,
kohlrabi, lentils, lettuce, lima beans, melons,
peanuts, peas, peppers, potatoes, prune,
pumpkin, radish, soybean, spinach,, squash,
tomato, turnips, and watermelon; foliar
application only use on apple, apricot,
blackberry, asparagus, blackeyed peas,
boysenberry, cantaloupe, celery, cherry,
currant, dewberry, gooseberry, grapes,
loganberry, nectarine, parsnip, peach, pear,
pineapple, plum, prune, quince, raspberry,
rutabaga, strawberry, sweet potatoes, vetch
(grown for seed), yams and youngberry
TERRESTRIAL NON-FOOD CROP: bluegrass (seed
treatment), bromegrass, orchardgrass,
timothygrass, conifers, elm, hawthorn,
ornamental bulb plants, ornamental lawns,
ornamental herbaceous plants, ornamental shade
trees, ornamental woody shrubs and ornamental
vines
GREENHOUSE FOOD CROP: mushrooms
DOMESTIC AND NON-DOMESTIC OUTDOOR: garbage
containers, garbage dumps, outdoor domestic
dwellings, recreational areas, urban and rural
areas, sewage disposal areas and sewer manholes
AQUATIC FOOD: cranberry
AQUATIC NON-FOOD: beaches, estuaries,
intermittently flooded areas, lakes, marshes,
-------
ponds, sloughs, streams, swamps, temporary rain
pools, irrigation canals, woodland pools,
rivers and shorelines
FORESTRY: forest trees
INDOOR: postharvest stored grain commodity and
premise treatment for barley, corn, oats, rye
and wheat; direct animal treatment for dogs,
cats, beef cattle, dairy cattle, goats, guinea
pigs, hogs, horses, ponies, poultry, and sheep;
agricultural premise use for barns (including
dairy barns), milk rooms, pens, sheds, stalls,
poultry houses, stables, feed rooms and manure
piles, kennels, dog sleeping quarters and cat
sleeping quarters; indoor domestic dwellings for
use on household contents such as human clothing
(including woolens); direct application to
humans; commercial and industrial use for food
processing plants (edible and inedible) and food
processing storage areas (including cereal
processing mills, cereal storage areas and flour
mills), mausoleums, mushroom house and equipment
treatment, transportation vehicles and empty
peanut warehouses
Pests Controlled: various nuisance species (some of
public health significance) including
cockroaches, mosquitoes, flies and
chiggers; various arthropods attacking
field crops, vegetables, fruits,
ornamentals, stored grain, livestock
and domestic pets
Methods of Application: sprays, fogs, paints,
ground and aerial equipment,
animal dust-bags, dips, sprays
and back-rubbers
Formulations: wettable powders, dusts, emulsifiable
concentrates, flowable concentrates,
liquid soluble concentrates, granules,
ready-to-use products (liquids) and
pressurized liquids
Annual Usage: 500,000 - 900,000 Ibs ai (1986 estimate)
Predominant Usage: alfalfa, livestock, home orchards and
ornamentals are the high volume use
sites, accounting for approximately
5.4%, 8.9%, 11.5%, and 11.5%,
respectively, of the total U.S.
-------
Mode of Activity:
U.S. Registrants:
annual usage
disrupts nervous system function
Chemical Formulators; Prentiss Drug &
Chemical Co., J.R. Simplot Co. ;
Dynachem Industries; Clover Chemical
Co.; Drexel Chemical Co.; Kincaid
Enterprises; and Wesley Industries
Number of Registrations:
438 federally-registered end-
use products. (EPs), 9 technical
products, 13 formulation
intermediates, and 20 "special
local need" registrations
issued under FIFRA section
24(c).
C. Data Call-In Notices Issued
The Agency has issued the following 3(c)(2)(B) Data Call-
in (DCI) Notices:
Date Issued
5/23/84
5/28/86
Data Required
Teratogenicity-1 species
Product Chemistry and
Residue Chemistry
Status
submitted data
determined to
be unacceptable
submitted data
determined to
"be unacceptable2
2 Data on fumigated commodities are not required, since
there are no registered use patterns. Data on irrigated crop
and food handling are required.
-------
III. AGENCY FINDINGS
A. SUMMARY
The Agency has reviewed all data currently supporting the
registration of methoxychlor as of November, 1987. Based on
the available data, EPA has reached the following
conclusions. The points summarized below are presented in
further detail, in the context of EPA's science findings and
additional data requirements, in Sections B through D.
1. With the exception of one mutagenicity study, there
are no acceptable acute, subchronic, or long-term
toxicology/bncogenicity studies available to support
technical methoxychlor. In the acceptable mutagenicity
study, an unscheduled DNA synthesis assay in mammalian cells
in culture, no abnormal DNA synthesis was noted at any of the
dose levels tested.
2. Based on acceptable laboratory data, technical
methoxychlor is characterized as very highly toxic to fish
and aquatic invertebrates, and practically nontoxic to birds
and bees. Based on theoretical calculations, both
terrestrial and aquatic uses of methoxychlor may pose a
hazard to aquatic organisms, although there is no field
evidence to support this. The impacts of methoxychlor use to
nontarget organisms will be assessed upon receipt of
ecological effects and environmental fate data.
3. The Agency cannot assess the potential for
methoxychlor to contaminate groundwater because acceptable
environmental fate studies are lacking. Preliminary data
suggest that methoxychlor is unlikely to contaminate
groundwater because of its low solubility and high rate of
adsorption to soil particles. However, environmental fate
data are needed in order for the Agency to assess the fate of
methoxychlor in the environment and its potential for
contaminating groundwater.
4. The nature of the residues of methoxychlor in plants
and animals is not adequately understood. None of the
tolerances for methoxychlor is adequately supported. Plant
and animal metabolism studies, residue studies, analytical
methodology, processing studies, and storage stability data
are needed before the Agency can determine the adequacy of
current tolerance levels.
8
-------
5. The Preliminary Limiting Dose (PLD)3 of methoxychlor
is .005 mg/kg/day. This is based on a rabbit teratology
study with a No Observed Effect Level (NOEL) of 5 mg/kg/day
for increased loss of litters and an uncertainty factor of
1000 to account for inter- and intraspecies differences, poor
quality of the study used and total lack of the subchronic
and chronic toxicity data base. A comparison of the TMRC
with the ADI is not appropriate at this time due to the
incompleteness of the toxicology and residue chemistry data
bases.
3 A limiting dose is set when the available data are
insufficient to establish an ADI or PADI. Examples of when a
limiting dose is used include (l) the use of studies did not
demonstrate a NOEL, but rather a minimal effect at the lowest
dose; (2) the use of studies which can not be fully
evaluated, such as studies in the open literature; and (3)
the use of studies which otherwise do not fulfill toxicity
data requirements (e.g. subchronic studies of less than 90
days, inhalation or dermal studies which do not allow a
conclusive determination of actual dosing)
-------
B. HEALTH EFFECTS ASSESSMENT
With the exception of one mutagenicity study, there are
no acceptable acute, subchronic or long-term toxicology
studies available to support registration of products
containing methoxychlor. Data are required as set forth in
Table A of this document.
In the mutagenicity study, a mammalian cell in culture
unscheduled DNA synthesis assay (UDS assay), no increase in
abnormal DNA synthesis was noted.
C. ENVIRONMENTAL CHARACTERISTICS AND EFFECTS
1. Ecological Effects
Based on acceptable laboratory data, technical
methoxychlor is characterized as practically nontoxic to
birds on both an acute oral and subacute dietary basis. The
single oral dose toxicity (LD50) value to bobwhite was
reported to be >2510 mg/kg. The subacute dietary LC5Q value
for this upland gamebird was reported to be >5620 ppm. No
data are available on the reproductive effects to birds. An
avian reproduction study is required. Depending upon the
results of this study and the required environmental fate
studies, terrestrial field studies may be required.
Terrestrial field studies are not required at this time,
since based on theoretical calculations, avian hazards in
the field are unlikely. The maximum expected residues of
methoxychlor on crops following a single application are
calculated to be from 540 to 2230 ppm; LC5Q values for
bobwhite are greater then 5000 ppm. Therefore, hazards to
terrestrial organisms are unlikely.
Based on acceptable laboratory data, technical
methoxychlor is characterized as very highly toxic to fish
and aquatic invertebrates on an acute basis. Acute LC5Q
values for fish range from 1.31 ppm for rainbow trout to
0.009 ppm for brook trout. The aquatic invertebrate LC5Q
value is .78 ppb for a daphnid and 1.4 ppb for a stonefly
(Pteronarcys). The LC50 value ranges from 0.002 ppm for
Atlantic salmon to 0.07 ppm for yellow perch for a 50%
granular formulation.
Fish and aquatic invertebrates may be at risk from
terrestrial (run-off and drift) and aquatic application of
methoxychlor based on theoretical calculations . The
estimated environmental concentrations (EECs) in aquatic
environments range from 15.3 to 732 ppb. These EECs are
10
-------
above reported LC50 values for fish and aquatic invertebrate
species at most application rates. Although these
calculations indicate that aquatic species may be at risk,
there are no field reports available suggesting a hazard
exists. The Agency will conduct a hazard assessment upon
receipt of acute and chronic aquatic studies, residue
chemistry data, and environmental fate data.
There is sufficient information to characterize
methoxychlor as relatively nontoxic to honey bees. Based on
an acceptable laboratory acute contact study, the acute
toxicity value =24 ug/bee.
2. Environmental Fate
The Agency is unable to assess the environmental fate of
methoxychlor because acceptable data are lacking. Data are
required as set forth in Table A. Preliminary data indicate
that methoxychlor is stable to : hydrolysis (half-life > 200
days); photodegradation in water (half-life of 4.5 months);
and aerobic soil metabolism (half-life > 3 months in sandy
loam soil). The half-life for anaerobic soil metabolism is
reported at less than 1 month in sandy loam soil.
Preliminary data also indicate that methoxychlor has a high
adsorption rate to soil sediment (K^ value is 620).
The Agency is unable to assess the potential for
methoxychlor to contaminate groundwater. Since methoxychlor
is essentially insoluble in water and has a high adsorption
rate to soil, groundwater contamination is likely to be
minimal. Methoxychlor residues have not been reported for
nearly 1300 wells that have been sampled in 10 States.
Other pesticide monitoring systems (Storet) indicate that
methoxychlor has been reported in 205 of 10859 samples from
widespread localities. However, the validity of these
reports has not been determined.
D. TOLERANCE ASSESSMENT
l. Tolerances Issued
Tolerances have been established for residues of
methoxychlor in a variety of raw agricultural commodities and
in meat, fat and meat byproducts (40 CFR 180.120).
Tolerances are expressed in terms of methoxychlor per se.
EPA has evaluated the residue and toxicology data supporting
tolerances for the purpose of determining:
0 Whether the current tolerances and food additive
regulations are sufficient to cover the actual
residues resulting from the registered uses
(including FIFRA section 24(c) uses).
11
-------
0 Whether group tolerances can be established in
accordance with 40 CFR 180.34(f).
0 Whether, in the absence of tolerances,
restrictions on use, grazing, or feeding of treated
commodities are necessary.
0 Whether the tolerances are expressed accurately
and in the current terminology.
The results of the Agency's evaluation are as follows:
a. Residue Data
1. No acceptable data are available on the nature of the
residues in both plants and animals, including identification
of major metabolites and degradates of the pesticide. Data
are required as set forth in Table A.
2. -No acceptable analytical methodology for determining
the levels of residues in plants and animals are available.
Data are required as set forth in Table A.
3. No acceptable data are available on the stability of
the compound in storage.
4. Data on the magnitude and levels of residues of the
pesticide in individual raw agricultural commodities, animal
products, and processed food and feed items are completely
lacking. Data are required as set forth in Table A.
5. The Food and Drug Administration (FDA) Total Diet
Studies as well as Surveillance and Compliance program for
domestic and imported commodities employ methodology capable
of determining residues of methoxychlor. Low levels of
methoxychlor per se were observed in a limited number of
commodities in the Total Diet Studies covering the period
4/82 through 4/86. Low levels of residues were observed in a
small number of commodities for which no tolerance for
methoxychlor residues have been established. FDA domestic
and imported surveillance monitoring covering the period FY
78 through April 12, 1988 indicated a limited number of
positive findings in various commodities.
b. Toxicology
The Preliminary Limiting Dose (PLD) of methoxychlor is
.005 mg/kg/day. This is based on a rabbit teratology study
with a No Observed Effect Level (NOEL) of 5 mg/kg/day for
increased loss of litters and with an uncertainty factor of
1000 to account for inter- and intraspecies differences, poor
12
-------
quality of the study used and total incompleteness of the
subchronic and chronic toxicity data base. The study is not
considered to be adequate to define a NOEL for purposes of
setting an Acceptable Daily Intake, since the experimental
design was considered to be inadequate. It is being used on
an interim basis for calculation of the PLD. A comparison
of the TMRC with the ADI is not appropriate at this time due
to the incompleteness of the toxicology and residue chemistry
data bases.
The regulatory results of the Agency's review are set out
in Section IV Regulatory Position and Rationale, items 7, 8,
9, and 10.
13
-------
IV. REGULATORY POSITION AND RATIONALE
A. SUMMARY OF REGULATORY POSITIONS AND RATIONALES
Based on review and evaluation of all available data and
other relevant information on methoxychlor, the Agency has
made the following determinations:
1. Methoxychlor is not being placed into Special Review
at this time.
Rationale: Since there are so few acceptable studies
available to support registration of products containing
methoxychlor, the Agency is not yet able to make a
determination as to whether any of the criteria of 40 CFR
154.7 have been met or exceeded.
2. The Agency will assess methoxychlor»s potential for
contaminating groundwater upon receipt of the required
environmental fate data set forth in Table A of this
Standard.
Rationale; The Agency is unable to assess the potential
for methoxychlor to contaminate groundwater because the
environmental fate of this chemical is uncharacterized.
Groundwater contamination is unlikely due to methoxychlor's
high rate of adsorption to soil sediment and insolubility in
water. When data required in this Standard have, been
received and evaluated, the Agency will assess
methoxychlor's potential for groundwater contamination.
3. The Agency is not establishing a longer reentry
interval for agricultural uses of methoxychlor beyond the
minimum reentry interval (sprays have dried, dusts have
settled, and vapors have dispersed).
Rationale; Current labels for end-use products indicate
that methoxychlor is of relatively low toxicity. Although
the available data have not been reviewed by the Agency to
determine whether they are valid or not, the Agency has no
reason to believe that methoxychlor poses a risk to persons
reentering treated fields after the minimum reentry interval.
Moreover, there are no reports of acute poisonings to persons
entering treated areas. For these reasons, the Agency has
determined that a longer reentry interval beyond the minimum
established reentry (sprays have dried, dusts have settled
and vapors have dispersed) is not necessary for this
chemical. Upon receipt and evaluation of the toxicology
data requested in this Standard, the Agency will reevaluate
its position regarding the need for reentry data/reentry
intervals.
14
-------
4. The U.S. Fish and Wildlife Service (USFWS) has
determined that use of methoxychlor as a mosquito larvicide
may jeopardize the continued existence of certain endangered
species. EPA is developing a program to reduce or eliminate
exposure to these species to a point where use does not
result in jeopardy. The Agency will issue a PR Notice
regarding any necessary labeling revisions when the program
is implemented. No additional labeling is required at this
time.
Rationale; Because of the demonstrated toxicity of
methoxychlor to nontarget fish and aquatic invertebrates,
methoxychlor was identified by the USFWS as likely to
jeopardize certain endangered aquatic species when used as a
mosquito larvicide. USFWS specified reasonable and prudent
alternatives to avoid jeopardizing the continued existence of
the identified species by these uses. EPA is working with
USFWS and other Federal and State agencies to implement the
alternatives in a technically sound manner.
In order to reduce or eliminate exposure to these
species to a point where the use does not result in jeopardy,
EPA required special labeling on EPs of methoxychlor under PR
Notice 87-4. Subsequent issuance of PR Notice 88-1 withdrew
PR Notice 87-4 pending development of a more focused program
to protect endangered species from adverse effects in the use
of pesticides. When the program is fully developed, notice
of any labeling necessary to protect endangered species will
be issued.
5. Methoxychlor products bear revised and updated
labeling that accurately reflects hazards to terrestrial and
aquatic organisms. The bee statement required under PR
Notice 68-19 is no longer appropriate and must be removed
from product labels.
Rationale: This requirement is based on laboratory
findings that show that methoxychlor is very highly toxic to
fish and aquatic invertebrates. Methoxychlor has been
demonstrated to be relatively nontoxic to bees based on the
results of an acceptable laboratory study.
6. The Agency is not classifying methoxychlor as a
restricted use pesticide at this time.
Rationale; FIFRA section 3(d)(l)(C) provides that some
or all uses of a pesticide will be classified for restricted
use if the Administrator determines that without such
restriction the pesticide "may generally cause unreasonable
adverse effects in man or the environment." The Agency is
unable to determine if methoxychlor meets any of the risk
criteria of 40 CFR 152.170 at this time due to extensive gaps
15
-------
in the data base. Upon receipt of data required under this
Standard, the Agency will apply the criteria of 40 CFR
152.170 to determine if any uses of methoxychlor warrant
restricted use classification.
7. The Agency will not approve any new food uses,
including minor uses until the Agency has received data
sufficient to perform a tolerance reassessment.
Rationale; None of the tolerances for methoxychlor is
adequately supported. Plant and animal metabolism studies,
residue studies, storage stability studies, processing
studies and analytical methods are needed before the Agency
can determine the adequacy of current tolerance levels and
perform a tolerance reassessment. Because of the extensive
residue chemistry data gaps, new food uses will not be
granted until these data gaps have been filled.
8. The Agency will revise commodity definitions for
certain raw agricultural commodities listed in 40 CFR
180.120.
Rationale; Certain listings in 40 CFR 180.120 are not
appropriate and will be corrected by the Agency:
a. The tolerance listing for yams,
boysenberries, dewberries and nectarines will be
deleted, since tolerances for residues in or on
other commodities apply to these commodities.
b. The listings for beets, radishes, rutabagas
and turnips, and the leaves of these plants will
be amended to reflect the appropriate commodity
definition, beet roots, radishes, rutabagas,
turnip tops, beet greens, radish tops, rutabaga
tops, and turnip tops.
c. The listings for beans and peas will be
amended to reflect the appropriate commodity
definition beans (dried and succulent) and peas
(dried and succulent).
d. The listing "grass for forage" will be
amended to reflect the appropriate commodity
definition grass forage.
e. The listing plums will be amended to reflect
the appropriate commodity definition plums (fresh
prunes).
f. The qualification "from preharvest and
postharvest application" will be deleted from
16
-------
the listing for sweet potatoes. There is no
postharvest use of methoxychlor for this
commodity.
g. The tolerance for horseradish will be revoked
since there is no registered use for this crop.
9. For the crops listed below, the registrant is given
the choice of developing and submitting data in support of
tolerances or of adding label restrictions against the
feeding and grazing of treated crops to livestock. Each
registrant must respond within 90 days of receipt of this
Standard to inform the Agency whether he will propose
tolerances or adopt the grazing/feeding restrictions. If he
selects to adopt label restrictions, labeling submitted at
the 9-month deadline must include the grazing/feeding
prohibitions. Refer to Section V for acceptable wording of
the grazing/feeding restrictions.
Pea vines and pea vine hay
Cowpea vines and cowpea hay
Soybean hay and straw
Corn forage.
Pineapple forage
Rationale: Tolerances are required for raw agricultural
commodities used as feed and forage for livestock and
tolerances. Label restrictions prohibiting grazing/feeding
prevent residues from occurring in meat and milk.
10. The current label restriction for asparagus which
permits application up to the day of harvest provided the
plant is washed and blanched must be deleted.
Rationale; Residue data are not available to support use
on asparagus up to the day of harvest. .The residue data
required under this Standard will support application with a
3-day preharvest interval (PHI)
11. The Agency is requiring specific analysis of
methoxychlor for the potential impurities 1,1,1-trichloro-
2,2-bis(p-chlorophenyl)ethane (DDT) and other structurally
similar compounds.
Rationale; The Agency is requiring specific analysis of
methoxychlor for these potential impurities because
methoxychlor is an analogue of DDT.
12. The label for EPA SLN No. NV-800013 must be amended
to incorporate a restriction against direct application to
flowing water within 1/2 mile of a potable water intake.
17
-------
Rationale: EPA SLN No. NV-800013 allows for direct
application to NV river water. The restriction is needed to
assure that the present 0.1 ppm Acceptable Residue Level in
Drinking Water (ARLDW)4 will not be exceeded under this use.
13. The Agency will not assign priority review for
methoxychlor studies. Studies submitted in response to this
Standard will be reviewed when the Agency conducts a second-
round review of methoxychlor. Studies that are flagged in
accordance with 40 CFR 158.34 will be given immediate review
upon receipt.
Rationale; Available data do not suggest significant
human health, environmental, or ecological concerns that
justify priority review of data.
14. While data gaps are being filled, currently
registered products containing methoxychlor may be sold,
distributed, formulated, and used, subject to the terms and
conditions specified in this Registration Standard.
Registrants must provide or .agree to develop additional data,
as specified in the Data Appendices, in order to maintain
existing registrations.
Rationale; Even when authorized under FIFRA sections
3(c)(2)(B) and 3(c)(7), the Agency may elect not to cancel or
withhold registration even though data are missing or are
inadequate. Issuance of this Standard provides a mechanism
for identifying data needs. These data will be reviewed and
evaluated, after which the Agency will determine if
additional regulatory actions are necessary.
V. REQUIRED LABELING STATEMENTS AND COMPLIANCE DATES
All products must bear appropriate labeling as
specified in 40 CFR 156.10 and below.
Pesticide products containing this pesticide as an
active ingredient may not be released for shipment by the
registrant after January 1990 unless the product bears
amended labeling that complies with the requirements of
FIFRA, as set out in this Registration standard.
Pesticide products containing this pesticide as an
active ingredient may not be distributed or sold by any
4 An acceptable residue level in drinking water (ARLDW)
of 0.1 ppm has been established under the Safe Drinking Water
Act (Quality Criteria for Water. July 1986, USEPA,
Washington, D.C. 20460., p. 164)
18
-------
person after January 1991 unless that product bears amended
labeling that complies with the requirements of FIFRA, as
specified in this Standard.
a. Manufacturing-Use Products (MPs)
1. The ingredient statement for MPs must declare
the active ingredient as:
Methoxychlor: 1,l,l-trichloro-2,2-bis (4-
methoxyphenyl)ethane
2. Labels for MPs must bear the following
identifying phrase directly beneath the product name:
"An insecticide for formulating use only."
3. In the directions for use, the following
statement must appear:
"Formulators using this product are responsible
for obtaining EPA registration of their formulated product."
4. In the directions for use, the following
statement regarding acceptable use patterns must appear:
"For formulation into end-use insecticide
products intended only for (list acceptable sites)."5
5. If detailed instructions for formulating are
not provided on the label, the following statement must
appear:
"Refer to 'attached Technical Bulletin for
formulating and other information."
6. The following statements are required to
appear under the "Environmental Hazards" heading:
"This pesticide is toxic to fish and aquatic
invertebrates. 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 discharge effluent
containing this product to sewer systems without previously
5 The Use Index (EPA Compendium of Acceptable Uses)
(for availability see Section I) lists all federally-
registered uses of methoxychlor, as well as approved maximum
application rates and frequencies. No use may be included on
the label where the registrant fails to agree to comply with
the data requirements for that use pattern.
19
-------
notifying the sewage treatment plant authority. For
guidance, contact your state Water Board or Regional Office
of the EPA."
b. End-Use Products (EPs)
1. The ingredient statement for EPs must declare
the active ingredient as:
Methoxychlor: 1,1,l-trichloro-2, 2-bis(p-
methoxyphenyl) ethane
2. All EPs allowing for nonaquatic uses (except
seed treatment and forestry) must bear the following
environmental hazards statement:
"This pesticide is toxic to fish and aquatic
invertebrates. Drift and runoff may be hazardous to aquatic
organisms in neighboring areas. Do not apply directly to
water or wetlands (swamps, bogs, marshes, and potholes). Do
not contaminate water when disposing of equipment
washwaters.
3. All EPs allowing for seed treatment use must
bear the following environmental hazards statement:
"This pesticide is toxic to fish and aquatic
invertebrates. Cover or collect treated seeds spilled on soil
surface. Do not contaminate water when disposing of
equipment washwaters."
4. All EPs allowing for forestry use must bear the
following environmental hazards statement:
"This pesticide is toxic to fish and aquatic
invertebrates. Do not apply directly to water or wetlands
(swamps, bogs, marshes, and potholes). Aerial application
over such sites is permissible only when they are not visible
from above the tree canopy. Drift and runoff from treated
areas may be hazardous to aquatic organisms in neighboring
areas. Do not contaminate water when disposing of equipment
washwaters."
5. All EPs allowing for aquatic use must bear the
following environmental hazards statement:
"This pesticide is toxic to fish and aquatic
invertebrates. Drift and runoff may be hazardous to aquatic
organisms in neighboring areas. Do not contaminate water
when disposing of equipment washwaters."
20
-------
6. The EPA SLN NV800013, allowing for use in
flowing water, must bear the following restriction:
11 Water treated with methoxychlor must not be
released within 1/2 mile upstream of a potable water intake
in flowing water (i.e., river or stream)."
7. All products allowing for outdoor use on
agricultural sites must bear the following updated worker
safety rules and reentry protection statements:
"Do not enter, or allow entry into treated areas
until [sprays have dried/dusts have settled/vapors have
dispersed, as applicable] to perform hand labor tasks. A
person may enter the area to perform other tasks only if the
person is wearing the personal protective equipment listed on
the label for a pesticide handler."
Do not apply this product in a way that will
contact unprotected workers, either directly or through
drift. Only protected handlers wearing long pants, long
sleeved shirts, socks, shoes and chemical resistant gloves
may be in the area during application."
8. All EPs allowing for use on peas must bear the
following grazing and feeding restrictions:
''Do not graze or feed treated pea vines or pea
hay to livestock."
9. All EPs allowing for use on cowpeas must bear
the following grazing and feeding restrictions:
"Do not graze or feed treated cowpea vines or
cowpea hay to livestock."
10. All EPs allowing for use on soybeans must bear
the following grazing and feeding restrictions:
"Do not graze or feed treated soybean hay or
straw to livestock."
11. All EPs allowing for use on corn must bear the
following feeding restriction:
"Do not feed treated corn to livestock."
12. All EPs allowing for use on pineapples must
bear the following feeding and grazing restrictions:
"Do not graze or feed treated pineapple forage
to livestock."
21
-------
13. The bee statement, "This product is toxic to
bees and should not be applied when bees are actively
visiting the area," required by PR Notice 68-19, must be
deleted from end use product labels on which it appears.
14. All end use products bearing directions for
direct application to livestock and poultry must be amended
to include a maximum rate of application in terms of active
ingredient per head or per unit area, or the equivalent which
can be converted. In addition, a minimum interval between
applications must be specified.
VI. 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 submittal 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 B6.
6Data 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 Registration
Standard. Table B lists product-Specific data applicable to
manufacturing-use products. The data in Tables A and B need not
be submitted by an end-use producer who is eligible for the
generic data 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 submittal of product-specific data for end-use
products at this time. Therefore, most Registration standards do
not contain a Table C.
22
-------
3. The labeling requirements specified for
manufacturing use products in Section IV.
4. Administrative requirements (application forms,
Confidential Statement of Formula, data compensation
provisions) associated with reregistration.
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 generic data exemption7, the
data requirements listed in Table C.
3. If not eligible for the generic data exemption, the
data requirements listed in Table A and the data
requirements listed in Table C.
4. The labeling requirements specified for end use
7If you purchase from another producer and use as the source
of your active ingredient only EPA-registered products, you are
eligible for the generic data 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 the data
requirements in Table A.
23
-------
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 generic data exemption, the
data requirements listed in Tables A and C.
2. If eligible for the generic data 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.8
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 f emulator's
exemption (FIFRA sec. 3(c)(2)(D) and 40 CFR 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.
Registrations granted after issuance of this Standard will
be conditioned upon submittal or citation of the data listed in
this Registration Standard.
24
-------
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 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 generic data
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 Generic Data
Exemption Statement.
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
submittal 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 DCI 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
25
-------
8580-1, enclosed) for each of your products. On that form
you must state which of the following six methods you will
use to comply with the DCI requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
submit the data on which you will rely. You must also
provide EPA with documentary evidence that an agreement has
been formed which allows you to rely upon the data to be
submitted. Such evidence may be: (1) your letter offering to
join in an agreement and the other registrant's acceptance of
your offer, (2) a written statement by the parties that an
agreement exists, or (3) a written statement by the person
who will be submitting the data that you may rely upon its
submittal. 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, as part of your 90-day response. 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
consortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submittals 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
26
-------
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
registrant and proof of the other registrant's receipt of
your offer (such as a certified mail receipt). Your offer
must, at a minimum, contain the following language or its
equivalent:
[Your company name] offers to share in
the burden of producing the data
required pursuant to FIFRA sec.
3(c)(2)(B) in the [name of active
ingredient] Registration standard upon
terms to be agreed or failing agreement
to be bound by binding arbitration as
provided by FIFRA sec. 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 timeframe. 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
27
-------
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. The Agency will
respond in writing to your request for a waiver.
5. You request that EPA amend your registration by
deleting the uses for which the data are needed. You are not
required to submit data for uses which are no longer on your
label.
6. You request voluntary cancellation of the
registration of your product(s) for which the data are
needed.
E. Registrant Requests Regarding Data Requirements and
Agency Responses
All requests for modification of data requirements
(inapplicability, waiver), approval of protocols or protocol
changes, or time extensions must be submitted in writing. The
original requirement remains in effect unless the Agency has
notified you in writing that it has agreed to a change in the
requirement. While being considered by the Agency, such
requests for -changes in the requirements do not alter the
original requirements or extend the time allowed for meeting
the requirement.
F. Test Protocols and Standards
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. All testing must
be conducted in accordance with applicable Good Laboratory
Practices regulations in 40 CFR Part 160.
The Pesticide Assessment 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
28
-------
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.
G. Procedures for requesting a change in test 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 submittal
of the data, nor will extensions generally be given to
conduct studies due to submittal of inappropriate protocols.
The Agency will respond in writing to your request for
protocol approval or change.
H. 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.
EPA will view failure to request an extension before the
data submittal 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. The Agency will
respond in writing to any requests for extension of time.
I. Data Format and Reporting Requirements
All data submitted in response to this Notice must comply
29
-------
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). All studies must be submitted in the
form of a final report; a preliminary report will not be
considered to fulfill the submittal requirement.
J. 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 for the
registrant is not consistent with the Act. Accordingly, the
Agency does not anticipate granting permission to sell or
distribute existing stocks of suspended product except in
rare circumstances. If you believe that your product will be
suspended or cancelled and that an existing stocks provision
should be granted, you have the burden of clearly
demonstrating to EPA that granting such permission would be
consistent with the Act. The following information must be
included in any request for an existing stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of
existing stocks and your estimate of the time required for
their sale or distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of 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.
30
-------
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 through J. 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.
VIII. REQUIREMENT FOR SUBMITTAL 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 156.10 (see Appendix II - LABELING and
SUMMARY). In addition, labeling language specific to
products containing this pesticide is specified in Section
IV.D of this Registra-tion Standard. Responses to this
Registration Standard must include draft labeling for Agency
review.
Labeling must 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. 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.
If you fail to submit revised labeling as required,
which complies with 40 CFR 156.10 and the specific
instructions in Section IV.D., EPA may seek to cancel the
registration of your product under FIFRA sec. 6.
IX. INSTRUCTIONS FOR SUBMITTAL
All submittals in response to this Registration Standard
must be sent to the following address:
Office of Pesticide Programs
OPP Mailroom (TS-767C)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
Attn: Methoxychlor Registration Standard
31
-------
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 for each product subject to this Registration
Standard:
a. Generic Data Exemption Statement (EPA Form
8580-3), if applicable, or the "FIFRA Section 3(c)(2)(B)
Summary Sheet" (EPA Form 8580-1), with appropriate
attachments.
b. Confidential Statement of Formula (EPA Form
8570-4).
c. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR
152.80-152.99.
2. Within 9 months from receipt of this document you
must submit:
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.
d. Product Specific Data Report (EPA Form 8580-4).
3. Within the times set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is
delayed or aborted so that the schedule cannot be met,
immediately notify the Agency 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:
a. Generic Data Exemption Statement (EPA Form
8580-3), if applicable, or the FIFRA sec. 3(c)(2)(B) Summary
Sheet, with appropriate attachments (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form
8570-4)
32
-------
2. Within 9 months of receipt of this document, you must
submit:
Three copies of draft labeling, including the
container label and any associated supplemental labeling.
3. Within the time frames set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is
delayed or aborted so that the schedule cannot be met,
immediately notify the Agency 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:
a. Generic data exemption Statement (EPA Form
8580-3), if applicable, or the FIFRA Section 3(c)(2)(B)
Summary Sheet, with appropriate attachments (EPA Form
8580-1) .
b. Confidential Statement of Formula (EPA Form
8570-4).
2. Within 9 months from receipt of this document you
must submit:
if
a. Two copies of any product-specific data, i
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.
3. Within the times set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is
delayed or aborted so that the schedule cannot be met,
immediately notify the Agency of the problem, the reasons for
the problem, and your proposed course of action.
D. End Use Products containing the subject active
ingredient as one of multiple active ingredients
1. Within 90 days from receipt of this document, you
must submit:
33
-------
a. Generic data exemption Statement (EPA Form
8580-3), if applicable, or the FIFRA Section 3(c)(2)(B)
Summary Sheet, with appropriate attachments (EPA Form
8580-1).
b. Confidential Statement of Formula (EPA Form
8570-4).
2. Within 9 months from the receipt of this document,
you must submit:
Three copies of draft labeling, including the container
label and any associated supplemental labeling.
3. Within the times set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is
delayed or aborted so that the schedule cannot be met,
immediately notify the Agency of the problem, the reasons for
the problem, and your proposed course of action.
E. Intrastate Products
Applications for full Federal registration of intrastate
products were required to be submitted no later than July 31,
1988. Unless an application for registration was submitted
by that date, no product may be released for shipment by the
producer after July 31, 1988.
34
-------
I. DATA APPENDICES
35
-------
TGUIDE-1
GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements for
the pesticides covered by this Registration Standard.
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.
r contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 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 Prot 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
36
-------
TGUIDE-2
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I = Indoor
Any other designations will be defined in a footnote to the
table.
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that completely satisfy
this data requirement. These data may be cited by
other registrants in accordance with data compensation
requirements of Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such
data do not fully satisfy the data requirement. In
some cases, the Agency may possess data on one of two
required species or may possess data on one test
substance but not all. The term may also indicate that
the data available to EPA are incomplete. In this
case, when the data are clarified, or additional
details of the testing submitted by the original data
submitter, the data may be determined to be acceptable.
If this is the case, a footnote to the table will
usually say so.
HQ - 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
information.
5. Bibliographic citation (Column 5). If the Agency has
acceptable data in its files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no MRID
number has been assigned. Refer to the Bibliography Appendices
for a complete citation of the study.
6. Must additional data be submitted? (Column 6). This column
indicates whether the data must be submitted to the Agency. If
column 3 indicates that the Agency already has data, this column
will usually indicate NO. If column e 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
37
-------
TGUIDE-3
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 t requires
that data be submitted, this column indicates when the data are
to be submitted, based on the issuance date of the Registration
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.
38
-------
39
Table A
Generic Data Requirements for Methoxychlor
Test
Data Reouirement Substance
Part 158 r SubDart C - Product Chemi
Product Identity and Composition
61-2 - Description of Beginning
Materials and
Manufacturing Process
61-3 - Discussion of Formation
.stry
TGAI
TGAI
Must Additional
Does EPA Data Be Submit-
Have Data to ted Under FIFRA Timef rame
Use Satisfy This Bibliographic Section for
Patterns Requirement?!/ Citation!/ 3(c)(2HB)? Submission2
All No
All No
Yes3-/ 9 Months
Yes^/ 9 Months
of Impurities
Analysis and Certification of Product Ingredients
62-1 - Preliminary Analysis of
Product Samples
TGAI
All No
Yes5-/ 12 Months
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
63-7 - Density, Bulk Density,
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
All No
All NO
All NO
All NO
All
All
Yes 9 Months
Yes 9 Months
Yes 9 Months
Yes^/ 9 Months
Yes^/ 9 Months
Yes 9 Months
or Specific Gravity
-------
40
Table A
Generic Data Requirements for Methoxychlor
Data Requirement
Test Use
Substance Patterns
Does EPA
Have Data to
Satisfy This
Requirement?!/
Bibliographic
Citationl/
Must Additional
Data Be Submit-
ted tftider FIFRA Timef rame
Section for
3(cH2HB)? SubmissionZ/
Subpart C - Product: Chemistry
Physical and Chemical Characteristics (cont'd)
63-8 - Solubility TGAI or PAI All
63-9 - Vapor Pressure TGAI or PAI All
63-10 - Dissociation Constant TGAI or PAI N/A
63-11 - Octanol/Water PAI All
Partition
Coefficient
Yes
Yes
Yes^/
63-12 - pH
63-13 - Stability
TGAI
TGAI
All
All
Yes
9 Months
9 Months
9 Months
9 Months
9 Months
Part 158. Subpart C - Product Chemistry Footnotes
I/Although product chemistry data may have been submitted in the past, the Agency has determined that these data must be
resubmitted for each pesticide. New requirements have been introduced and previously submitted data must be updated.
Therefore, bibliographic citations for the old data are not applicable.
2/Due dates refer to number of months following receipt of this Registration Standard, unless otherwise indicated.
3_/The following information must be provided: (i) the name and address of the producer of the technical grade of
the active ingredient (TGAI): (ii) the brand name, trade name or other commercial designation, the name and address of
the producer, and information concerning the composition of each starting material; (iii) a general characterization
of the process (e.g., batch or continuous); (iv) a flow chart of the chemical equations of each intended reaction
-------
41
Table A
Generic Data Requirements for Methoxychlor (cont'd)
Part 158, Subpart C - Product Chemistry Footnotes (cont'd)
occurring at each step of the process, the necessary reaction conditions, and the duration of each step of the process
and of the entire process; (v) the identity of the materials used to produce the product, their relative amounts, and
the order in which they are added; (vi) a description of the equipment used; (vii) a description of the conditions
(e.g., temperature, pressure, pH, humidity) that are controlled during each step of the process; (viii) a description
of any purification procedures (including procedures to recover or recycle starting materials, intermediates or the
substance produced); and (ix) a description of the procedures used to assure consistent composition of the substance
produced (quality control methods).
4/A. discussion regarding the origin of the following potential inpurities must be provided: (i) each impurity
associated with the active ingredient which was found to be present in any analysis of the product conducted by or for
the registrant, and (ii) each impurity which the registrant has reason to believe may be present at a level equal to
or greater than 0.1% (w/w) based on the composition of each starting material, intended and side reactions which may
occur during production, the possible degradation of ingredients after production, post-production reactions between
ingredients, possible contamination from packaging materials or production equipment, and process control,
purification and quality control measures.
5/Five or more representative samples must be analyzed for the amount of active ingredient and each impurity present
at 0.1% or greater. Specific analysis for the potential impurities l--l,2,2-tris(p-methoxyphenyl)ethylene
(TACE), l/l,l-trichloro-2,2-bis(p-chlorophenyl)ethane (DDT), and its structurally similar compounds is required at
levels < 0.1%. If the product is produced by a batch process, five separate batches should be represented in
preliminary analyses. Complete and detailed descriptions of the method' used for sample analysis must be submitted,
including statements of their precision and accuracy. The preliminary analysis report should include the identity and
quantity of each ingredient for which analysis is conducted along with the mean and relative standard deviation of the
analytical results. Based on the preliminary analysis, a statement of the composition of the TGAI must be provided.
Ł/Data on melting point are required if the technical chemical is a solid at room temperature.
I/Data on boiling point are required if the technical product is a liquid at room temperature.
8/Data on octanoI/water partition coefficient are required if the technical chemical is organic and nonpolar.
9/Data on pH are required if the test substance is dispersible in water.
-------
42
Table. A
Generic Data Requirements for Methoxychlor
Data Reouirement
158.240 Residue Chemistry
171-4
171-4
171-4
71-4
- Nature of the Residue
(Metabolism)
- Plants
- Nature of the Residue
(Metabolism)
- Livestock
- Residue Analytical
Methods
- Storage Stability
Test
Substance
PAIRA
EAIRA and
plant
metabolites
TGAI and
metabolites
TEP and
metabolites
Must Additional
Does EPA Data Be Submit-
Have Data to ted Under FIFRA Timef rame
Satisfy This Bibliographic Section for
Reouirement? Citation 3(c)(2)(B)? Submission!
Partially 00146645 Yes^/
No Yes^/
Partially 00070728,00070729, Reserved^/
00097051,00108733,
, 00113268,00113273,
' 00135287,00164734,
1 00164739
/
Partially 00164734 Yes
18 Months
18 Months
15 Months
171-4 - Magnitude of the
Residue in Plants5-^6-/
- Root and Tuber
Vegetables
- Beet roots
- Carrots
- Horseradish
TEP
TEP
TEP
NO
NO
NO
Yes7-/
Yes2/
18 Months
18 Months
18 Months
-------
43
Table A
Generic Data Requirements for Methoxychlor (cont'd)
Data Requirement
158.240 Residue Chemistry
171-4 - Magnitude of the
Residue in Plants^/
- Root and Tuber
Vegetables (cont'd)
- Parsnips
- Potatoes
(Processed)
- Radishes
- Rutabagas
- Sweet Potatoes
- Turnips
- Yams
- Leaves of Root and
Tuber Vegetables
- Beet greens
- Radish tops
Test
Substance
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
Must Additional
Does EPA Data Be Subtnit-
Have Data to ted Under FIFRA Timef rame
Satisfy This Bibliographic Section for
Requirement? Citation 3(cH2)(B)? Submission!
No
No
No
No
No
No
No
No
No
No
YesJŁ/ 18 Months
Yesii/ 18 Months
Yes^2/ 24 Months
Yes^3-/ is Months
YesW is Months
Yes15/ 18 Months
YeslS/ 18 Months
Yes1^-/ is Months
YesiS/ 18 Months
YesH^/ is Months
- Rutabaga tops
. - Turnip tops
TEP
TEP
NO
No
18 Months
18 Months
-------
44
Table A
Generic Data Requirements for Methoxychlor (cont'd)
Data Reouirement
158.240
171-4 -
Residue Chemistry
Magnitude of the
Residue in Plants^-^/
- Leafy Vegetables
- Celery
- Lettuce
- Spinach
- Brassica Leafy
Vegetables
- Broccoli
- Brussels sprouts
- Cabbage
- Cauliflower
- Collards
- Kale
- Kohlrabi
Test
Substance
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
Does EPA
Have Data to
Satisfy This Bibliographic
Requirement? Citation
No
No
No
No
ii
No I
No '
No
No
No
No
Must Additional
Data Be Submit-
ted Under FIFRA Timef rame
Section for
3 (c H 2 ) (B) ? Submission!
Yes21a/ 18 Months
Yes22/ is Months
Yes^3-/ 18 Months
Yes2-4/ 18 Months
Yes2^/ 18 Months
Yes2^/ 18 Months
Yes2^/ is Months
Yes2^/ 18 Months
Yes2-^/ 18 Months
Yes30/ 18 Months
-------
45
Table A
Generic Data Requirements for Methoxychlor (cont'd)
Data Reouirement
Test
Substance
Does ERA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submit-
ted Under FIFRA Timef rame
Section for
3(c)(2HB)? Submission!/
158.240 Residue Chemistry
171-4 - Magnitude of the
Residue in
- Legume Vegetables
- Beans (succulent/
dry)
(Processed)
- Peas (succulent/dry)
- Soybeans
(Processed)
- Foliage of Legume
Vegetables
- Cowpea vines/hay
- Soybean forage/hay
- Fruiting Vegetables
- Eggplant
TEP
TEP
TEP
TEP
TEP
TEP
Mb
No
No
No
No
No
No
No
Yes31/
ye&22/
18 Months
24 Months
18 Months
18 Months
24 Months
18 Months
18 Months
18 Months
-------
46
Table A
Generic Data Requirements for Methoxychlor (cont'd)
Data Requirement
Test
Substance
Does EPA
Have Data to
Satisfy This Bibliographic
Requirement? Citation
Must Additional
Data Be Submit-
ted Under FIFRA Timef rame
Section for
3(cH2HBl? Submission!/
158.240 Residue Chemistry
171-4 - Magnitude of the
Residue in Plants^-^/
- Peppers TEP
- Tomatoes TEP
(Processed)
Cucurbit Vegetables
- Cucumbers TEP
- Melons TEP
- Pumpkins TEP
- Squash, summer TEP
- Pome Fruits
- Apples TEP
(Processed)
No
No
No
No
No
No
No
No
No
Yes42/
Yes45/
YesM/
18 Months
18 Months
24 Months
18 Months
18 Months
18 Months
18 Months
18 Months
24 Months
-------
47
Table A
Generic Data Requirements for Methoxychlor (cont'd)
Data Requirement
Test
Substance
Does EPA
Have Data to
Satisfy This Bibliographic
Requirement? Citation
Must Additional
Data Be Submit-
ted Under FIFRA Timeframe
Section for
3(cH2HB)? Submission!/
158.240 Residue Chemistry
171-4 - Magnitude of the
Residue in Plants^-^/
- Pome Fruits (cont'd)
- Pears TEP
- Quinces TEP
- Stone Fruits
- Apricots TEP
- Cherries TEP
- Peaches TEP
- Plums (fresh prunes) TEP
(Processed)
- Small Fruits and Berries
- Blackberries TEP
- Blueberries TEP
No
No
No
No
No
No
No
No
No
Yes4J/
Yes52/
Yes53/
Yes54/
Yee5fi/
18 Months
18 Months
18 Months
18 Months
18 Months
18 Months
24 Months
18 Months
18 Months
-------
48
Table A
Generic Data Requirements for Methoxychlor (cont'd)
Test
Data Reouirement
158.240 Residue Chemistry
171-4 - Magnitude of the
Residue in
- Small Fruits and Berries (cont'd)
- Boysenberries , TEP
dewberries, logan-
berries, youngberries
- Cranberries
- Currants
- Gooseberries
- Grapes
(Processed)
- Raspberries
- Strax^rries
Does EPA
Have Data to
Satisfy This Bibliographic
Recnii rement ? Citation
Must Additional
Data Be Submit-
ted Under FIFRA Timef rame
Section for
No
TEP
TEP
TEP
TEP
TEP
TEP
NO
NO
NO
NO
NO
NO
NO
18 Months
18 Months
18 Months
18 Months
18 Months
24 Months
18 Months
18 Months
-------
49
Table A
Generic Data Requirements for Methoxychlor (cont'd)
Data Reouirement
Test
Substance
Does EPA
Have Data to
Satisfy This
Reouirement?
Bibliographic
Citation
Most Additional
Data Be Submit-
ted Under FIFRA
Section
3(cH2HB)?
Timeframe
for
Submission!,
158.240 Residue Chemistry
171-4 - Magnitude of the
Residue in
- Cereal Grains
- Corn, fresh TEP
(Processed)
- Grass Forage, Fodder,
and Hay
- Grass, forage and hay TEP
- Nbngrass Animal Feeds
TEP
- Alfalfa forage and
hay
- Clover forage and
hay
TEP
- Miscellaneous Commodities
- Asparagus TEP
No
No
No
No
No
18 Months
24 Months
18 months
18 Months
18 Months
No
18 Months
-------
50
Table A
'
Generic Data Requirements for Methaxychlor (cont'd)
f
Does EPA
Must Additional
Data Be Submit-
Have Data to ted tftider FIFRA Timef rame
Test Satisfy This Bibliographic Section for
Data Reauirement Substance Reouirement? Citation 3(c)(2)(B)? Submlssionl
158.240 Residue Chemistry
171-4 - Magnitude of the
Residue in Plants^/
- Miscellaneous Commodities (cont'd)
- Mushrooms TEP No
- Peanuts TEP No
(Processed) No
- Pineapples TEP No
(Processed) No
- Crops with Registered PAIRA, TEP No
Seed Treatments Only
- Crops Grown Solely for
Seed
- Vetch TEP No
Yes2°-/ 18 Months
YesTJ/ IB Months
Yes7-^/ 24 Months
Yes7-3-/ is Months
Yes7-4./ 24 Months
YesjT-5-/ 18 Months
Yes26/ 18 Months
171-4 - Magnitude of Residue in TEP Partially 00089808,00093382 Yes7-7-/ 18 Months
Stored Commodities
(Processed)
No
24 Months
-------
51
Table A
Generic Data Requirements for Methoxychlor (cont'd)
Data Requirement
Test
Substance
Does EPA
Have Data to
Satisfy This
Requi rement ?
Bibliographic
Citation
Must Additional
Data Be Submit-
ted Under FIFRA
Section
3(c)(2HB)?
Timeframe
for
Submissionl/
158.240 Residue Chemistry
171-4 - Magnitude of the
Residue in
171-4 - Magnitude of Residue in TGAI or plant
Meat/Milk/Poultry/ metabolites
Eggs
171-4 - Magnitude of Residue in PAIRA, EP
1 Potable Water/Fish
171-4 - Magnitude of Residue EP
Irrigated Crops
171-4 - Magnitude of Residue EP
Food Handling
Establ ishments
Partially 00025687,00089064, Reserved5-^/
00105471,00113273,
00127393,05005125
NO
No
No
Yen5'gQ
00135287
Yes5*32/
15 Months
18 Months
12 Months
158.'240 Residue Chemistry (Footnotes)
I/Due dates refer to the number of months following receipt of this Registration standard, unless otherwise
indicated.
2/Data are required depicting the uptake, distribution, and metabolism of ring-labeled [14C]methoxychlor in or on
three dissimilar food crops (e.g., a root crop, oilseed crop, and a leafy vegetable). If metabolism is not similar
in the three crops, additional studies using other crops may be required. A completely characterized test substance
representative of technical methoxychlor (including impurities) used in commercial formulations must be applied
foliarly several times up to and including the day of harvest at rates sufficiently high to permit characterization
of 14C-residues. The identities and quantities of residues in or on mature plant parts must be determined in order
-------
52
Table A
Generic Data Requirements for Methoxychlor (cont'd)
158.240 Residue Chemistry Footnotes (cont'd)
(.'
to elucidate terminal residues. Representative samples from the I required metabolism studies must also be analyzed
using accepted enforcement methods to ascertain that these methods will determine all possible metabolites of concern.
J/Metabolism studies utilizing ruminants and poultry are required/ Animals must be dosed orally for a minimum of
3 days with ring-labeled [15C]methoxychlor at a level sufficient to make residue identification and quantification
possible. Milk and eggs must be collected twice a day during the dosing period. Animals must be sacrificed within
24 hours of the final dose. The distribution and identity of residues must be determined in milk, eggs, liver,
kidney, muscle, and fat. Samples from these studies must also be analyzed using accepted enforcement methods to
ascertain that these methods will determine all possible metabolites of concern. In addition, ruminants, poultry,
and swine must be treated dermally with ring-labeled [14C]methoxychlor at a concentration that will result in
sufficient residues in the tissues for characterization. Animals must be sacrificed 24 hours after treatment and
residues characterized in muscle, fat, kidney, liver, and skin (poultry and swine only). Representative samples
from these studies must also be analyzed using accepted enforcement methods to ascertain that these methods will
determine all possible metabolites of concern.
4/The nature of the residue in plants and animals has not been adequately described. If the metabolism studies
requested in the sections "Nature of the Residue in Plants" and "Nature of the Residue in Animals" reveal the
presence of additional metabolites of concern in or on plant and/or animal commodities, additional validated methods
for data collection and tolerance enforcement will be required.
5/The sample storage conditions and intervals must be supplied for all required and previously submitted residue
data for plant and animal commodities. Storage stability data in support of previously submitted residue data are
required for only those samples deemed to be useful for tolerance assessment. Data are also required which depict
the decline in methoxychlor residue levels in commodities stored under the range of conditions and for the range in
intervals specified. Crop samples bearing measurable weathered residues or fortified with methoxychlor and fortified
meat, milk, and egg samples must be analyzed immediately after harvest or fortification and again after storage
intervals that represent actual residue sample storage conditions and allow for reasonable unforeseen delays in
sample analysis. In laboratory tests using fortified samples, the pure active ingredient and pure metabolites (if
necessary) must be used. However, if field weathered samples are used, the test substance must be a typical end-use
product. For additional guidance on conducting storage stability studies, the registrant is referred to an August
1987 Position Document on the Effects of Storage on Validity of Pesticide Residue Data available from OTIS under order
no. PB88112362/AS.
^/Unless otherwise specified, each formulation class registered for use on a given crop must be represented in separate
tests. Data on aerial application must be provided for one or more representative crops from each crop group having
members with registered methoxychlor uses allowing aerial application. If residues resulting from aerial application
exceed those from ground application, additional residue tests may be required on other crops. The requested residue
data must reflect the maximum number of applications and minimum interval between treatments specified on the labels
or proposed by the registrant to appear on the labels.
-------
53
Table A
Generic Data Requirements for Methoxychlor (cont'd)
158.240 Residue Chemistry Footnotes (cont'd)
2/Data are required depicting methoxychlor residues of concern in or on beet roots harvested 7 days following
multiple foliar applications of a representative D, WP/D or F1C, and an EC formulation at 2.25 ai/A and 14 days
following applications of these formulations at 5 Ib ai/A, or at the maximum rate permitted for a given formulation
class. Tests must be conducted in NY, OR, and TX.
fl/Data are required depicting methoxychlor residues of concern in or on carrots harvested 7 days following multiple
foliar applications of a representative WP/D or F1C, and an EC formulation at 2.25 ai/A and 14 days following
applications of these formulations at 5 Ib ai/A, or at the maximum rate permitted for a given formulation class.
Tests must be conducted in CA, FL, and TX.
3/The registrant must propose directions for use of methoxychlor on horseradish and submit appropriate supporting
residue data or the established tolerance will be revoked.
IQ/Data are required to determine methoxychlor residues of concern in or on parsnips. The registrant must contact
the Agency within the allowed ninety (90) day period indicating his intention to support this use, and either: a)
request a determination of the specific formulations, rates, and application schedule to be tested on parsnips; or b)
indicate support of the use on turnip and request that the required data for that use pattern be used to support the
use on parsnips. A maximum number of applications per season or a maximum seasonal foliar use rate must be proposed.
An appropriate tolerance level proposal for residues of methoxychlor in or on parsnips is also required.
11/Data are required depicting methoxychlor residues of concern in or on potatoes harvested on the day of the last of
multiple foliar applications of representative D, WP/D, and EC formulations at 2.25 Ib ai/A or at the maximum rate
permitted for a given formulation class. Tests must be conducted in ID, WA, ME, OR, and WI.
12/Data are required depicting residues of methoxychlor in chips, granules, and wet and dry peel from potatoes
bearing measurable weathered residues. If residues concentrate in any of these commodities, an appropriate feed/food
additive tolerance must be proposed.
13,/Data are required depicting methoxychlor residues of concern in or on radishes harvested 7 days following multiple
foliar applications of a representative WP/D or Fie, and an EC formulation at 5 Ib ai/A. Tests must be conducted in
FL and MI.
14/Data are required depicting methoxychlor residues of concern in or on rutabagas harvested 7 days following
multiple foliar applications of a representative WP/D or F1C, and an EC formulation at 2.25 Ib ai/A and 14 days
following applications of these formulations at 5 Ib ai/A/ or at the maximum rate permitted for a given formulation
class. Tests must be conducted in MN, WA, and WI.
ISyData are required depicting methoxychlor residues of concern in or on sweet potatoes harvested on the day of the
last of multiple foliar applications of the 10% D formulation, the 50% WP/D, and a representative EC formulation at
2.25 Ib ai/A or at the maximum rate permitted for a given formulation class. Tests must be conducted in CA, LA, and
NC.
!S/Data are required depicting methoxychlor residues of concern in or on turnips harvested 1 day following multiple
foliar applications of a representative D, WP/D, or EC formulation at 1.75 Ib ai/A, 7 days following applications of
these formulations at 2.25 Ib ai/A, and 14 days following application of these formulations at 5 Ib ai/A. Tests must
be conducted in CA. PA, GA, and TX.
-------
54
Table A
Generic Data Requirements for Methoxychlor (cont'd)
158.240 Residue Chemistry Footnotes (cont'd)
17/Data are required to determine methoxychlor residues of concern in or on yams. The registrant must contact the
Agency within the allowed ninety (90) day period indicating his intention to support this use, and either: a) request
a determination of the specific formulations, rates, and application schedule to be tested on yams; or b) indicate
support of the use on sweet potatoes and request that the required data for that use pattern be used to support the use
on yams. j
JJ/Data are required to determine methoxychlor residues of concern in or on beet greens. The registrant must contact
the Agency within the allowed ninety (90) day period indicating his intention to support this use, and either a)
request a determination of the specific formulations, rates, and application schedule to be tested on beet greens; or
b) indicate support of the use on turnip tops and request that the required data for that use pattern be used to
support the use on beet greens.
19/Data are required to determine methoxychlor residues of concern in or on radish tops. The registrant must contact
the Agency within the allowed ninety (90) day period indicating his intention to support this use, and either:' a)
request a determination of the specific formulations, rates, and application schedule to be tested on radish tops; or
b) indicate support of the use on turnip tops and request that the required data for that use pattern be used to
support the use on radish tops.
2Q/Data are required to determine methoxychlor residues of concern in or on rutabaga tops. The registrant must contact
the Agency within the allowed ninety (90) day period indicating his intention to support this use, and either: a)
request a determination of the specific formulations, rates, and application schedule to be tested on rutabaga tops;
or b) indicate support of the use on turnip tops and request that the required data for that use pattern be used to
support the use on rutabaga tops.
21/Data are required depicting methoxychlor residues of concern in or on turnip tops harvested 14 days following
multiple foliar applications of representative D, WP/D, and EC formulations at 5 Ib ai/A or at the maximum rate
permitted for a given formulation class. Tests must be conducted in TN, FL, GA, AL, and TX.
21a/Residue data depicting residues of methoxychlor in or on untriirened celery treated foliar ly at 0.5 oz/100 sq. ft. of
a 5% D (EPA Reg. No. 8580-283) and harvested 7 days after application are required. Data must be obtained from the
states of CA, FL, and ME. A maximum number of applications per season or a maximum seasonal foliar use rate must be
proposed. An appropriate tolerance level proposal for levels of methoxychlor in or on celery is also required.
22/Data are required depicting methoxychlor residues of concern in or on lettuce (with and without wrapper leaves)
harvested 14 days after the last of multiple foliar applications of a D and EC formulation at 2.25 Ib ai/A and the 50%
WP/D formulation at 2.25 Ib ai/A or at the maximum rate permitted for a given formulation class. Tests must be
conducted in CA.
-------
55
Table A
Generic Data Requirements for Methoxychlor (cont'd)
158.240 Residue Chemistry Footnotes (cont'd)
23/Data are required depicting methoxychlor residues of concern in or on spinach harvested 14 days after the last of
multiple foliar applications of the 5% D, the 50% WP/D, and a representative EC formulation at 5 Ib ai/A. Tests must
be conducted in CA, TX, and NJ.
24/Data are required depicting methoxychlor residues of concern in or on broccoli harvested 14 days following the last
of multiple foliar applications of a D formulation, a representative EC formulation, and the 50% WP/D formulation at
5 Ib ai/A or the maximum rate permitted for a given formulation class. Tests must be conducted in CA and TX.
25/Data are required to determine methoxychlor residues of concern in or on Brussels sprouts. The registrant must
contact the Agency within the allowed ninety (90) day period indicating his intention to support this use, and
either: a) request a determination of the specific formulations, rates, and application schedule to be tested on
Brussels sprouts; or b) indicate support of the use on broccoli and request that the required data for that use
pattern be used to support the use on Brussels sprouts.
26/Data are required depicting methoxychlor residues of concern in or on cabbage (with and without wrapper leaves)
harvested 7 days following the last of multiple foliar applications of a D formulation, a representative EC
formulation, and the 50% WP/D formulation at 5 Ib ai/A or the maximum rate permitted for a given formulation class.,,
Tests must be conducted in CA, FL, NY, TX, and WI.
22/Data are required depicting methoxychlor residues of concern in or on cauliflower harvested 7 days following the
last of multiple foliar applications of a D formulation, a representative EC formulation, and the 50% WP/D formulation
at 5 Ib ai/A or the maximum rate permitted for a given formulation class. Tests must be conducted in CA, NY, and TX.
23/Data are required depicting methoxychlor residues of concern in or on collards harvested 14 days following the
last of multiple foliar applications of a D formulation, a representative EC formulation, and the 50% WP/D formulation
at 5 Ib ai/A or the maximum rate permitted for a given formulation class. Tests must be conducted in AZ and GA.
29/Data are required to determine methoxychlor residues of concern in or on kale. The registrant must contact the
Agency within the allowed ninety (90) day period indicating his intention to support this use, and either: a) request
a determination of the specific formulations, rates, and application schedule to be tested on kale; or b) indicate
support of the use on collards and request that the required data for that use pattern be used to support the use on
kale.
30_/Data are required to determine methoxychlor residues of concern in or on kohlrabi. The registrant must contact
the Agency within the allowed ninety (90) day period indicating his intention to support this use, and either: a)
request a determination of the specific formulations, rates, and application schedule to be tested on kohlrabi; or b)
indicate support of the use on broccoli and request that the required data for that use pattern be used to support the
use on kohlrabi.
31/Data are required depicting methoxychlor residues of concern in or on beans (both succulent and dry) harvested 3
days after the last of multiple foliar applications (at 7-day intervals) of a representative EC formulation, a F1C or
WP/D formulation, and a D formulation at 5 Ib ai/A or at the maximum rate permitted for a given formulation class.
Tests must be conducted in 1) CA, OR or ID; 2) MI or NE; 3) NY; and 4) WI.
-------
56
Table A
Generic Data Requirements for Methoxychlor (cont'd)
158.240 Residue Chemistry Footnotes (cont'd)
22/Data are required depicting methoxychlor residues in or on cannery waste processed from beans bearing measurable,
weathered residues. If the data indicate a potential for residue concentration in this commodity, an appropriate food
additive tolerance must be proposed.
33/Data are required depicting methoxychlor residues of concern in or on peas (both succulent and dry) harvested 7
days after the last of multiple foliar applications (at 7-<3ay intervals) of a representative EC formulation, a F1C
or WP/D formulation, and a D formulation at 5 Ib ai/A or at the maximum rate permitted for a given formulation
class. Tests must be conducted in MN, WA, and WI. Since pea vines and pea vine hay are raw agricultural commodi-
ties (RACs), the registrant must propose tolerances for residues /of methoxychlor in or on pea vines and pea vine hay
and submit appropriate supporting residue data. A pregrazing interval must also be specified. Alternatively, the
registrant may elect to propose a label amendment that restricts/feeding or grazing treated pea vines and pea vine
hay to livestock. -
34/A tolerance must be proposed, and data must be submitted (in support of the tolerance) depicting methoxychlor
residues in or on soybeans harvested 7 days following the last of multiple foliar applications of a representative D,
EC, and a WP/D formulation at 3 Ib ai/A. Tests must be conducted in AZ, IL, IN, and IA.
3J5/A processing study depicting methoxychlor residues in or on products (meal, hulls, soapstock, crude oil, and
refined oil) and in grain dust from the processing of soybeans bearing measurable weathered residues is required. If
the data indicate a potential for residue concentration in any of these commodities, an appropriate food additive
tolerance must be proposed.
36/Data are required depicting methoxychlor residues of concern in or on cowpea forage and cowpea hay harvested 3
days after the last of multiple foliar applications of representative D, EC, and WP/D or F1C formulations at 5 Ib
ai/A or at the maximum rate and minimum PHI permitted for a given formulation class. Tests must be conducted in CA
and TX. The registrant must propose a tolerance for residues of methoxychlor in or on cowpea hay. Alternatively,
the registrant may propose a label amendment restricting the feeding or grazing of treated cowpea hay and vines to
livestock.
32/Data are required depicting methoxychlor residues in or on soybean forage harvested 7 days following the last of
multiple foliar applications of a representative D, EC, and a WP/D formulation at 3 Ib ai/A. Tests must be conducted
in AZ, IL, IN, and IA. Since soybean hay and straw are RACs, the registrant must propose tolerances for residues of
methoxychlor in or on soybean hay and straw and submit appropriate supporting residue data. Alternatively, the
registrant may propose a label amendment that restricts feeding or grazing of treated soybean hay and straw to
livestock.
l§/Data are required to determine methoxychlor residues of concern in or on eggplant. The registrant must contact
the Agency within the allowed ninety (90) day period indicating his intention to support this use, and either: a)
request a determination of the specific formulations, ratep, and application schedule to be tested on eggplant; or b)
indicate support of the use on tomatoes and request that the required data for that use pattern be used to support
the use on eggplant.
-------
57
Table A ,
Generic Data Requirements for Methoxychlor (cont'd)
158.240 Residue Chemistry Footnotes (cont'd)
_29/Data are required depicting methoxychlor residues of concern in or on peppers harvested 1 day following the last
of multiple foliar applications of representative D, WP/D or F1C, and EC formulations at 1.75 Ib ai/A and 7 days
following applications of the D and EC formulations at 2.25 Ib ai/A and the WP/D OR F1C formulation at 2.25 Ib ai/A.
Tests must be conducted in CA, FL, NC, and TX.
4Q/Data are required depicting methoxychlor residues of concern in or on tomatoes harvested 7 days following the last
of multiple foliar applications of representative D, EC, and WP/D or F1C formulations at 3.5 Ib ai/A or at the
highest rate permitted for a given formulation class. Data are also required depicting these residues in or on
tomatoes harvested 1 day following the last of multiple foliar applications of these formulations at 1.75 Ib ai/A or
at the maximum rate permitted for a given formulation class. The tests must be conducted in CA and FL.
41/A processing study depicting residues of methoxychlor in dry pomace, puree, catsup, and juice processed
from tomatoes bearing measurable weathered residues is required. If residues concentrate in any product, an
appropriate food/feed additive tolerance must be proposed.
42/Data are required depicting methoxychlor residues of concern in or on cucumbers harvested 7 days following
multiple foliar applications of a D formulation, a representative EC formulation, and the 50% WP/D formulation at &•
Ib ai/A or the maximum registered rate permitted for a given formulation class. Tests must be conducted in CA, FL,
MI, NC, and TX.
43/Data are required depicting methoxychlor residues of concern in or on melons harvested 7 days following multiple
foliar applications of a D formulation, a representative EC formulation, and the 50% WP/D formulation at 5 Ib ai/A or
the maximum registered rate permitted for a given formulation class. Data are also required depicting these residues
in samples harvested 1 day following the last of multiple foliar applications of these same formulations at 2 Ib ai/A
or at the maximum rate for a given formulation class permitted 1 day before harvest. Tests must be conducted in CA
and TX.
44/Data are required to determine methoxychlor residues of concern in or on pumpkins. The registrant must contact
the Agency within the allowed ninety (90) day period indicating his intention to support this use, and either: a)
request a determination of the specific formulations, rates, and application schedule to be tested on pumpkins; or b)
indicate support of the use on melons and request that the required data for that use pattern be used to support the
use on pumpkins.
45_/Data are required depicting methoxychlor residues of concern in or on summer squash harvested 7 days following the
last of multiple foliar applications of a D formulation, a representative EC formulation, and the 50% WP/D formulation
at 5 Ib ai/A or the maximum registered rate permitted for a given formulation class. Data are also required depicting
these residues in samples harvested 1 day following the last of multiple foliar applications of these same
formulations at 2 Ib ai/A or at the maximum rate for a given formulation class permitted 1 day before harvest. Tests
must be conducted in CA, FL, NJ, and TX.
-------
58
Table A
Generic Data Requirements for Methoxychlor (cont'd)
158.240 Residue Chemistry Footnotes (cont'd)
46/Data are required depicting methoxychlor residues of concern in or on apples harvested 7 days following the last
of multiple foliar applications of the 50% WP/D formulation at 10 Ib ai/A and a representative EC formulation at 12 Ib
ai/A. Tests must be conducted in CA, MI, NY, and WA.
42/Data are required depicting methoxychlor residues of concern in dry apple pomace and juice processed from apples
bearing measurable weathered residues. If residues concentrate in any of these processed commodities, an appropriate
food/feed additive tolerance must be proposed.
4S/Data are required depicting methoxychlor residues of concern in or on pears harvested 7 days following the last of
multiple foliar applications of the 50% WP/D at 10 Ib ai/A and a representative EC formulation at 12 Ib ai/A. Tests
must be conducted in CA.
49_/Data are required to determine methoxychlor residues of concern in or on quinces. The registrant must contact the
Agency within the allowed ninety (90) day period indicating his intention to support this use, and either: a) request
a determination of the specific formulations, rates, and application schedule to be tested on quinces; or b) indicate
support of the use on apples and request that the required data for that use pattern be used to support the use on
quinces. /
5J3/Data are required to determine methoxychlor residues of concern/in or on apricots. The registrant must contact
the Agency within the allowed ninety (90) day period indicating his intention to support this use, and either: a)
request a determination of the specific formulations, rates, and application schedule to be tested on apricots; or b)
indicate support of the use on peaches and request that the required data for that use pattern be used to support the
use on apricots.
51/Data are required depicting methoxychlor residues of concern in or on cherries harvested 7 days following the 'last
of multiple applications of the 50% WP or WP/D formulations at 10 Ub ai/a and a representative EC and F1C formulation
at 12 Ib ai/A or the maximum rate permitted for a given formulation class. Tests on sweet cherries must be conducted
in CA, MI, and WA. Tests on tart cherries must be conducted in MI.
5_2/Data are required depicting methoxychlor residues of concern in or on peaches harvested 21 days following the last
of multiple applications of the 50% WP or WP/D formulations at 10 Ib ai/A and a representative EC and F1C formulation
at 12 Ib ai/A or the maximum rate permitted for a given formulation class. Tests must be conducted in CA and GA or
SC.
5J/Data are required depicting methoxychlor residues of concern in or on plums harvested 7 days following the last of
multiple applications of the 50% WP or WP/D formulations at 10 Ib ai/A and a representative EC and F1C formulation at
12 Ib ai/A or the maximum rate permitted for a given formulation class. Tests must be conducted in MI and OR.
5J/A processing study is required depicting methoxychlor residues of concern in dried prunes processed from fresh
prunes bearing measurable weathered residues. If residues concentrate in this item, an appropriate food additive
tolerance must be proposed.
-------
59
Table A
Generic Data Requirements for Methoxychlor (cont'd)
158.240 Residue Chemistry Footnotes (cont'd)
55/Data are required depicting methoxychlor residues of concern in or on blackberries harvested 14 days following the
last of multiple foliar applications of the 10% D, a representative EC formulation, and the 50% WP/D or 4 Ib/gal F1C
formulation at 5 Ib ai/A or at the maximum rate permitted for a given formulation class 14 days prior to harvest.
Data are also required depicting these same residues in or on blackberries harvested 3 days following the last of
multiple foliar applications of a representative formulation of each class at 1.75 Ib ai/A or at the maximum rate
permitted for a given formulation class 3 days prior to harvest. The tests must be conducted in OR and CA. Data are
also required depicting methoxychlor residues of concern in or on blackberries harvested on the day of the last of
multiple foliar applications of the 2 Ib/gal EC formulation at 1.75 Ib ai/A. The test must be conducted in OR.
Alternatively, the registrant may elect to cancel this use permitted under EPA SLN No. QR-780031.
56/Data are required depicting methoxychlor residues of concern in or on blueberries harvested 14 days following the
last of multiple foliar applications of representative D, EC, and the 50% WP/D or the 4 Ib/gal F1C formulations at 5
Ib ai/A or at the maximum rate permitted for a given formulation class. Tests must be conducted in MI, NJ, and NC.
5_7_/Data are required to determine methoxychlor residues of concern in or on these berries. The registrant must
contact the Agency within the allowed ninety (90) day period indicating his intention to support this use, and
either: a) request a determination of the specific formulations, rates, and application schedule to be tested on
these berries; or b) indicate support of the use on blackberries and request that the required data for that use
pattern be used to support the use on these berries.
58/Data are required depicting residues of methoxychlor in or on cranberries harvested 14 days following the last of
multiple foliar applications of a representative EC and the 50% WP/D or 4 Ib/gal F1C formulation at 5 Ib ai/A or at
the maximum rate permitted for a given formulation class. The tests must be conducted in MA and WI.
59/Data are required to determine methoxychlor residues of concern in or on currants. The registrant must contact
the Agency within the allowed ninety (90) day period indicating his intention to support this use, and either: a)
request a determination of the specific formulations, rates, and application schedule to be tested on currants; or
b) indicate support of the use on blueberries and request that the required data for that use pattern be used to
support the use on currants.
60/Data are required to determine methoxychlor residues of concern in or on gooseberries. The registrant must
contact the Agency within the allowed ninety (90) day period indicating his intention to support this use, and
either: a) request a determination of the specific formulations, rates, and application schedule to be tested on
gooseberries; or b) indicate support of the use on blueberries and request that the required data for that use
pattern be used to support the use on gooseberries.
61/Data are required depicting methoxychlor residues of concern in or on grapes harvested 14 days following the last
of multiple foliar applications of a representative EC and a WP/D or F1C formulation at 6 Ib ai/A or the maximum rate
permitted for a given formulation class. The tests must be conducted in CA and NY. Data are also required depicting
methoxychlor residues of concern in or on grapes harvested on the day of the last of multiple foliar applications of
the 50% WP formulation at 3 Ib ai/A. The tests must be conducted in AR. Alternatively, the registrant may elect to
cancel this use permitted under EPA SLN No. AR-770006.
-------
60
Ł2/Data are required depicting the potential for residue concentration in dry pomace, raisins, and raisin waste
processed from grapes bearing measurable weathered residues. If residues concentrate in any of these comodities, an
appropriate food/feed additive tolerance must be proposed.
6J/Data depicting methoxychlor residues of concern in or on strawberries harvested 14 days following the last of
multiple foliar applications of a representative D formulation, a F1C formulation or the 50% WP formulation, and a
representative EC formulation at 5 Ib ai/A or at the maximum rate permitted for a given formulation class 14 days
before harvest. In addition, data are required depicting residues in or on strawberries harvested 3 days after the
last of multiple foliar applications of each of these formulations at 1.75 Ib ai/A or at the maximum rate permitted
for a given formulation class 3 days before harvest. The tests must be conducted in CA and FL.
Ł4/Data are required depicting methoxychlor residues of concern in or on sweet corn harvested 7 days following the
last of multiple foliar applications of representative EC and either F1C or WP/D formulations at 2.25 Ib ai/A or the
maximum rate for a given formulation class permitted 7 days prior to harvest. In addition, data are required depicting
residues in or on com harvested 14 days following the last of multiple foliar applications of these same formulations
at 3 Ib ai/A or the maximum rate for a given formulation class. Tests must be conducted in MN, FL, IL or WI, and OR
or CA. The registrant must amend all pertinent product labels to specify whether use on field corn is intended. If
any labels are amended to include field corn, appropriate supporting residue data for corn grain will be required.
Since forage is an RAC of fresh sweet corn, a tolerance must be proposed for corn forage and appropriate supporting
residue data submitted. Alternatively, the registrant may elect to propose a restriction on the feeding of this
commodity to livestock.
65/Data are required depicting methoxychlor residues of concern in cannery waste processed from sweet corn bearing
measurable weathered residues. If residues concentrate, an appropriate feed additive tolerance must be proposed. The
requirement for cannery waste data may be waived if the registrant elects to submit the appropriate sweet corn forage
residue data. i
6Ł/Data are required depicting methoxychlor residues of concern in pr on Bermudagrass, bluegrass, and bromegrass or
fescue (as fresh grass and hay) harvested 7 days following the last of multiple foliar applications of the 5% D
formulation, the 50% WP/D formulation, and a representative EC formulation at 3 Ib ai/A. The registrant must propose
an appropriate tolerance for methoxychlor residues of concern in or on grass hay. Tests must be conducted in 1) ID,
MT, OR or WA; 2) KS, MQ, OK or TX; 3) , KY or TN; 4) AL, GA or MS, IA, NE, MN, ND or SD; and 5) NY or PA.
62/Data are required depicting methoxychlor residues of concern in or on alfalfa forage and hay (ca. 10% moisture
content) harvested 7 days following the last of multiple foliar applications of the 5% D formulation, a representative
EC formulation, and the 50% WP/D or 4 Ib/gal F1C formulation at 4.5 Ib ai/A. The registrant must propose an
appropriate tolerance for residues of methoxychlor in or on alfalfa hay. Tests must be conducted in CA, NY, and WI.
-------
61
Table A
Generic Data Requirements for Methoxychlor (cont'd)
158.240 Residue Chemistry Footnotes (cont'd)
63/Data are required depicting methoxychlor residues of concern in or on clover forage and hay harvested 7 days
following the last of multiple foliar applications of a representative EC, the 50% WP/D formulation, and the 5% D
formulation at 3 Ib ai/A. Test must be conducted in 1) ID, MI, MN, MS or GA; 2) NY; 3) OK; and 4) WI. The registrant
must propose an appropriate tolerance for methoxychlor residues of concern in or on clover hay and submit appropriate
supporting residue data.
Ł2/Data are required depicting methoxychlor residues of concern in or on asparagus harvested 3 and 7 days following
the last of multiple foliar applications of a D formulation, a representative EC formulation, and the 50% WP/D
formulation at 2.25 and 3.5 Ib ai/A, respectively. Tests must be conducted in CA or WA and ME. The registrant must
amend all pertinent labels removing the requirement of washing and blanching of samples when harvested prior to 3 days
following application at rates of up to 2.25 Ib ai/A. If the registrant's intent is to allow applications up to the
day of harvest, then appropriate residue data must be submitted.
22/Data are required depicting methoxychlor residues of concern in or on mushrooms resulting from applications to
mushroom houses with the 50% WP/D and the 4 Ib/gal EC formulations at 5.33 oz ai/500 sq ft. Applications must be
made daily for 7 days up to 7 days prior to mushroom emergence.
H/Data are required depicting methoxychlor residues of concern in or on mature peanuts and peanut forage harvested
7 days following the last of multiple foliar applications of the 5% D formulation, the 50% WP/D formulation, and a
representative EC formulation at 3 Ib ai/A or the maximum rate permitted for a given formulation class. Tests must be
conducted in AL, GA, and TX. The registrant must propose tolerances for methoxychlor residues of concern in or on the
RACs hulls and hay of peanuts and submit appropriate supporting residue data.
12/A processing study is required depicting methoxychlor residues in products (meal, soapstock, crude oil, and
refined oil) processed from peanuts bearing measurable weathered residues. If residues concentrate in any product, an
appropriate food/feed additive tolerance must be proposed.
23/Data are required depicting methoxychlor residues of concern in or on pineapples harvested 7 days following the
last of multiple foliar applications of the 2 Ib/gal EC formulation at 2 Ib ai/A. Tests must be conducted in HI.
Since pineapple forage is an RAC, the registrant must either propose a tolerance for pineapple forage and provide the
appropriate supporting residue data, or propose a feeding or grazing restriction.
24/A processing study depicting residues of methoxychlor in products (bran and juice) processed from pineapples
bearing measurable weathered residues is required. If residues concentrate in any product, an appropriate food/ feed
additive tolerance must be proposed.
25/Data are required depicting the uptake, distribution, metabolism, and total terminal residues of ring-labeled
[14C]methoxychlor in the food/feed commodities of cotton, flax, 'lespedeza, mustard, okra, onion, rice, safflower,
sunflower, and wheat (representative crops that are registered for seed treatment) resulting from seed treatment with
[14C]methoxychlor. studies must be conducted at the respective maximum labeled rates for the seed treatments of these
respective crops. Data are also required depicting methoxychlor residues in or on cotton, flax, lespedeza, mustard,
-------
62
Table A
Generic Data Requirements for Methoxychlor (cont'd)
158.240 Residue Chemistry Footnotes (cont'd)
okra, onion, rice, safflower, sunflower, and wheat resulting from seed treated with methoxychlor according to the label
directions of the product having the maximum permissible use rate. Samples of all RACs for each crop must be collected
at the shortest interval after planting at which time they could be used for food or feed purposes. Tolerances must be
proposed that reflect either the maximum expected residue levels or, if no measurable residues are detected, the limit
of detection of the analytical method. All processing studies, if needed, must utilize RACs bearing measurable
weathered residues.
16_/The registrant must propose appropriate tolerances for residues of methoxychlor in or on vetch forage and hay.
Samples should be taken at regular intervals following multiple foliar applications of the 2 Ib/gal EC formulation at
1 Ib ai/A to determine a reasonable FHI. Applications must be made by ground equipment in 20 gal/A and by aerial
equipment (in a separate test) in 5 gal/A. The registrant must propose a maximum number of applications per season
or a maximum season use rate. Tests should be conducted in OR to support the SOST. Residues should be determined in
hay and in forage from which hay was prepared. Alternatively, the registrant may elect to cancel the existing use.
77/Data are required depicting methoxychlor residues of concern in or on corn and wheat grain following the full
series of registered applications (empty-bin, surface spray, and fog) at both the 1 and 2X rates. The galvanized
metal bins used for storage should hold a minimum of 50 bushels of grain. Grain must be loaded in the bin 24 hours
following a residual wall application of an EC and the 4 Ib/gal F1C formulations at 0.4 Ib ai/1000 sq ft. After
loading, the surface of wheat and corn must be treated with the 2 Ib/gal EC and 4 Ib/gal F1C formulations at 0.4 Ib
ai/1000 sq ft grain surface, followed by a fog application of the 5% RTU formulation to the bin at 4 fl oz product/5000
cu ft. A separate test must be conducted at the 2X rate (0.8 Ib ai/1000 sq ft for the wall treatment, and 0.8 Ib
ai/1000 sq ft and 8 f 1 oz product/5000 cu ft for the surface and fog applications, respectively). Samples must be
taken from the center of the bin, at the wall, and off the top. (Multiple sampling must be done immediately after the
final (fog) treatment and at weekly intervals thereafter for 5 weeks. Sample storage conditions and intervals must
be reported. The registrant must propose label amendments for t/ie 4 Ib/gal F1C formulation reflecting use on
specific stored grains. Data are required depicting methoxychldr residues of concern in or on sorghum and rice
grain following the full series of registered applications (empty-bin and surface spray) at both the 1 and 2X
rates. The galvanized metal bins used for storage should hold a minimum of 50 bushels of grain. Grain must be
loaded in the bin 24 hours following a residual wall application of an EC and the 4 Ib/gal F1C formulations at 0.4
Ib ai/1000 sq ft. After loading, the surface of sorghum and rice must be treated with the 4 Ib/gal F1C formulation
at 0.4 Ib ai/1000 sq ft grain surface. A separate test must be conducted at the 2X rate (0.8 Ib ai/1000 sq ft for
the wall treatment and 0.8 Ib ai/1000 sq ft for the surface application). Samples must be taken from the center of
the bin, at the wall, and off the top. Multiple sampling must be done imnediately after the final (surface)
treatment and at weekly intervals thereafter for 5 weeks. Sample storage conditions and intervals must be reported.
When an appropriate tolerance for residues in or on stored treated wheat grain is determined, a food/feed additive
tolerance must be established for wheat grain dust.
-------
63
Table A
Generic Data Requirements for Methoxychlor (cont'd)
158.240 Residue Chemistry Footnotes (cont'd)
processing study is required depicting methoxychlor residues of concern in the milled product middlings from the
processing of wheat bearing measurable weathered residues. If residues concentrate, an appropriate food/feed additive
tolerance must be proposed. A tolerance must be proposed and appropriate supporting residue data submitted for corn
grain dust based on the following treatment regimen: corn grain dust must be collected immediately following
treatment of grain with the 2 Ib/gal EC formulation at 1 and 2 Ib ai/1000 bushels grain (1 and 2X the maximum amount
that the grain would be exposed to, assuming that a surface spray extends to a depth of 6 inches in a storage bin).
Applications may be made while tumbling approximately 10 bushels of grain in a cement mixer; approximately 1 Ib of
grain dust should be collected as it is produced while the grain is tumbled. Sample storage intervals and conditions
must be reported. Untreated control samples should be collected prior to treatment. A processing study is required
depicting methoxychlor residues of concern in wet milled products (starch, crude oil, and refined oil) and in dry
milled products (grits, meal, flour, and crude and refined oils) from the processing of field corn bearing measurable
weathered residues. If residues concentrate in any product, an appropriate food/feed additive tolerance must be
proposed. A processing study is required depicting methoxychlor residues of concern in milled products (hulls, bran,
and polished rice) and grain dust (see corn grain dust protocol above) from the processing of rice bearing measurable
weathered residues. If residues concentrate in any product, an appropriate food/feed additive tolerance must be
proposed. A processing study is required depicting methoxychlor residues of concern in milled products (flour and
starch) and grain dust (see corn grain dust protocol above) from the processing of sorghum bearing measurable
weathered residues. If residues concentrate in any product, an appropriate food/feed additive tolerance must be
proposed.
19/The registrant must amend all pertinent labels to specify a maximum application rate and a minimum interval
between applications. The rates must be expressed in terms of amount of active ingredient per head or per unit area,
or the equivalent which can readily be converted to such. On receipt of the data requested in the section entitled
"Nature of the Residue in Animals," the appropriate nature of tolerances for residues in animal products will be
determined and, with consideration for any newly found metabolites of toxicological concern, the adequacy of the
available data regarding the magnitude of residue in livestock and poultry will be determined. Depending on the
results of the required metabolism studies, additional feeding and dermal residue studies may be needed. The dermal
studies will be required for each species for which a dermal use is registered.
ŁQ/To support the NV registration (EPA SEIST No. NV-800013) , a metabolism study must be submitted in which fish are
exposed (for at least 3 days) to water containing [14C] methoxychlor at 0.2 ppm or a concentration sufficiently high to
permit complete quantification and characterization of 14C-residues in edible tissues (flesh and skin). Representative
samples must also be analyzed by proposed enforcement methods to ascertain that all residues of concern are
determined. In addition, the registrant must propose a tolerance or an exemption from the requirement of a tolerance
for methoxychlor in fish following registered aquatic use. This study should be completed and submitted prior to
initiation of the fish residue trial required below. Alternatively, the registrant may elect to cancel this use.
-------
64
To support the NV registration (EPA SLN Mb. NV-800013), data must .be submitted depicting methoxychlor residues of
concern in bottom feeders (e.g., catfish) and predators (e.g., bass) harvested after 1, 3, 7, and 10 days of exposure
to water containing 0.2 ppm methoxychlor. The registrant must propose a maximum seasonal use rate or limit on the
number of applications per season. Alternatively, the registrant may elect to cancel this use. Data are required
depicting methoxychlor residues of concern in (i) NV river water immediately following direct treatments, at 10-day
intervals by "drip station method" over a 15-minute period, with the 2 Ub/gal EC formulation at 0.2 ppm; and (ii) ID
and UT irrigation waters immediately following direct treatments with the 2 Ib/gal EC formulation at 0.3 ppm (1.69 Ib
ai/100 cu ft/second of water flow for 15 minutes). The registrant must also implement the following label
restrictions: Water treated with methoxychlor must not be released within 1/2 mile upstream of a potable water
intake in flowing water (i.e., river or stream) or within 1/2 mile of a potable water intake in a standing body of
water, such as a lake, pond, or reservoir.
Si/Data are required depicting methoxychlor residue of concern in or on a representative irrigated commodity from
each crop group grown in the States of ID and UT which utilize either soil or overhead irrigation as a standard
agricultural practice (i.e., multiple irrigation) using water containing 0.3 ppm of methoxychlor. Crops must be
harvested immediately after the final irrigation. In addition, the registrant must propose a maximum number of
times a field may be irrigated with treated water for each crop. The submitted data must reflect this maximum. Tests
must be conducted in ID and UT. Alternatively, the registrant may elect to cancel this use permitted under EPA SLN
Nos. ID-780020 and UT-790012.
jJ2/Data are required depicting methoxychlor residues of concern in food products resulting from applications of
methoxychlor in grain mills, food processing plants, and peanut warehouses. Tests are required in these
establishments utilizing an EC and an SC/L formulation as a crack and crevice treatment, and an RTU as fog treatment.
Tests must represent worst case scenarios for potential residue contamination of food products which might include,
but not be limited to, some of the following: (i) particulate aerosol contact with packaged products present at the
time of treatment; (ii) contact of packaged or stored foods with treated surfaces, such as flour sacks stacked on
treated floor surfaces in storage areas or peanuts (with and without shells) stored in treated warehouses; (iii)
treatment occurring near stacks of new or cleaned product containers that are then filled without being cleaned; or
(iv) tracking of residues by insects or rodents from treated areas to food or food contact surfaces.
-------
65
Table A
Generic Data Requirements for Methoxychlor
Data Requirement
Test Use
Substance Patterns
Does EPA
Have Data to
Satisfy This Bibliographic
ion
Section 158.290 Environmental Fate
Degradation Studies - Lab
161-1 - Hydrolysis
Photodegradation
161-2 - In Water
161-3 - On Soil
161-4 - In Air
Metabolism Studies - Lab
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
TGAI or PAIRA AtB,C,D,E,
G,H
TGAI or PAIRA A,B,C,D,G
TGAI or PAIRA A,G
TGAI or PAIRA A
TGAI or PAIRA A,B,E,G,H
TGAI or PAIRA A
162-3 - Anaerobic Aquatic TGAI or PAIRA C,D,G
162-4 - Aerobic Aquatic
TGAI or PAIRA C,D
NO
NO
NO
NO
NO
• NO
NO
Must Additional
Data Be Submit-
ted Under FIFRA Timeframe
Section for
3(cH2HB)?
Yes
Yes
Yes
Reserved2/
Yes
Yes
Yes
Yes
9 Months
9 Months
9 Months
27 Months
(12 Months -
Progress Report)
27 Months
(12 Months -
Progress Report)
27 Months
(12 Months -
Progress Report)
27 Months
(12 Months -
Progress Report)
-------
66
Table A
Generic Data Requirements for Methoxychlor (cont'd)
Data Requirement
Test
Substance
Use
Patterns
Does EPA
Have Data to
Satisfy This Bibliographic
Requirement? Citation
Must Additional
Data Be Submit-
ted Under FIFRA Timef rame
Section
3(c)(2)(B)?
for
Submission!/
Section 158.290 Environmental Fate
Mobility Studies
163-1 - Leaching and
Adsorption/
Desorption
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
Dissipation Studies - Field
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and Tank
Mixes
164-5 - Soil, Long-Term
TGAI or PAIRA A,B,C,D,Et
G,H
TEP
TEP
TEP
TEP
TEP
TEP
TEP
A,E
A,E
A,B,H
C,D
N/A
A,B,C
NO
NO
NO
NO
NO
NO
NO
Yes
Reserved2/'
Reserved2-/
Yes
Yes
12 Months
27 Months
(12 Months -
Progress Report)
27 Months
(12 Months -
Progress Report)
39 Months4/
(Acceptable
Protocol 90 Days
(12 Months -
Progress Report)
-------
67
Table A
Generic Data Requirements for Methoxychlor (cont'd)
Must Additional
Does EPA Data Be Submit-
Have Data to ted Uftder FIFRA Timeframe
Test Use Satisfy This Bibliographic Section for
Data Requirement Substance Patterns Reouirement? Citation 3(cM2HB)? Submiasioni/
Section
158.290 Environmental Fate
-i nii^ r ii IT --^^•^•^a.^
Accumulation Studies
165-1 -
165-2 -
165-3 -
165-4 -
165-5 -
Section
132-1 -
132-1 -
133-3 -
133-4 -
Rotational Crops EAIRA A,C No
(Confined)
Rotational Crops TEP A,C No
(Field)
Irrigated Crops TEP C,D No
In Fish TGAI or PAIRA A,BfC,D,G Nb
In Aquatic Nontarget TEP D,G No
Organisms
158.390 Reentry Protection
Foliar Dissipation TEP A,B No
Soil Dissipation TEP A No
Dermal Exposure TEP A,B No
Inhalation Exposure TEP A,B No
Yes
Reserved5-/
Yes
Yes
Yes
Reserved6-/
Reserved6-/
Reserved6-/
Reserved6-/
39 Months4/
(12 Months -
Progress Report)
39 Months^/
(12 Months -
Progress Report)
12 Months
12 Months
-------
68
Table A
Generic Data Requirements for Methoxychlor (cont'd)
Most Additional
Does EPA Data Be Submit-
Have Data to ted Under FIFRA Timeframe
Test Use Satisfy This Bibliographic Section for
Data Requirement Substance Patterns Requirement? Citation 3(c)(2)(B)? Submissionl/
Section 158.440 - Sorav Drift
201-1 - Droplet Size Spectrum TEP A,B No Reserved^/
201-1 - Drift Field Evaluation TEP A,B No Reserved^/
Section 158.75 - Other Exposure Data
Mixer/Loader and Applicator .
Exposure Data No Reserved^/
I/Due dates refer to number of months following receipt of this Registration Standard, unless otherwise indicated.
2/Data are reserved pending receipt and evaluation of vapor pressure data.
3/Due to results of preliminary data showing persistence of methoxychlor under aerobic conditions, the Agency is
requiring a long-term soil field dissipation study. The short-term study is waived.
A separate study must be performed with a typical end-use product for each registered formulation category (D, WP, ED,
and FC). The method of application must include both foliar application and seed treatment. An acceptable protocol is
due 90 days from receipt of this Standard.
4/The first progress report is due 12 months from receipt of this Standard. Interim reports are due annually thereafter.
5/Reserved pending the results of the confined accumulation in rotational crops study.
6/Nb adequate data exist to fully evaluate the toxicity potential of methoxychlor. Therefore, this data requirement is
reserved pending the results of acceptable toxicology studies.
-------
69
Table A
Generic Data Requirements for Methoxychlor
Data
Reouirement
Section 158.340 Toxicology
81-1
81-2
81-3
81-4
81-5
81-6
81-7
- Acute Oral - Rat
- Acute Dermal
- Acute Inhalation
- Eye Irritation
- Dermal Irritation
- Dermal Sensitization
- Acute Delayed
Test
Substance
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Use
Patterns
A,B,D,E,
A,B,D,E,
A,B,D,E,
A,B,D,E,
A,B,D,E,
A,B,D,E,
N/A
Does EPA
Have Data to
Satisfy This Bibliographic
Reouirement? Citation
No
NO
NO
NO
NO
Partially 00062704
No
Must Additional
Data Be Submit-
ted Under FIFRA Timef rame
Section for
3(cH2HB)? Submission!
Yes
Yes
Yes
Yes
Yes
Yes2/
No3/
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
Neurotoxic ity
Subchronic Testing
82-1 - 90-Day Feeding
- Rodent
TGAI A,B,D,E
No
No*/
- Nbnrodent
TGAI A,B,D,E
No
-------
70
Table A
Generic Data Requirements for Methoxychlor (cont'd)
Data Reouirement
Test Use
Substance Patterns
Does EPA
Have Data to
Satisfy This Bibliographic
Reuirement? Citation
Must Additional
Data Be Submit-
ted Under FIFRA Timef rame
Section for
3(c)(2) (B)? Submission!/
Section 158.340 Toxicology
Subchronic Testing (cont'd)
82-2 - 21-Day Dermal
82-3 - 90-Day Dermal
82-4 - 90-Day Inhalation
TGAI
TGAI
TGAI
A,B,D,E,
A,B,D,E,
A,B,D,E,
82-5 - 90-Day Neurotoxicity TGAI N/A
Chronic Testing
83-1 - Chronic Testing
- Rodent TGAI A,B,D,E
- Nonrodent TGAI A,B,D,E
No
No
No
NO
NO
Yes
No5-/
No*/
Yes
Yes
9 Months
50 Months7-/
(12 Months -
Progress Report)
50 Months7-/
(12 Months -
Progress Report)
-------
71
Table A
Generic Data Requirements for Methoxychlor (cont'd)
Data Requirement
Test Use
Substance Patterns
Does EPA
Have Data to
Satisfy This Bibliographic
Requirement? Citation
Must Additional
Data Be Submit-
ted Under FIFRA Timef rame
Section for
3
-------
72
Table A
Generic Data Requirements for Methoxychlor (cont'd)
lirement
Test Use
Substance Patterns
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Must Additional
Data Be Submit-
ted Under FIFRA Timeframe
Section for
3(cH2HBl? Submissior
Section 158.340 Toxicology
Mutagenicity Testing (cont'd)
84-2 - Chromosome Aberration
84-4 - Other Mechanisms of
Mutagenicity
Special Testing
85-1 - General Metabolism
85-2 - Domestic Animal
TGAI
TGAI
A,B,D,E,
A,B,D,E
Yes
00028625
00132952
00133008
NO
Yes
12 Months
EAI or EAIRA A,B,D,E
Choice I
No
No
Yes
24 Months
(12 Months-
Progress Report)
Reserved^/
Section 158.340 Toxicology - Footnotes
I/Due dates refer to the number of months following receipt of this Registration Standard, unless otherwise indicated.
2/A submitted study is available under MRID No. 000144386. This study only partially satisfies the requirement because
test methodology was not provided. This registrant has the option of upgrading this study by providing a description
of test methodology used, or submitting a new study. Within 90 days, the registrant must inform the Agency of the
option chosen: 1) to provide the missing information to upgrade the study, or 2) to submit a new study. In either
case the new study or the submission of additional data is due at the 9-month deadline.
-------
73
Table A
Generic Data Requirements for Methoxychlor
Section 158.340 Toxicology - Footnotes (cont'd)
.3/Wb acute delayed neurotoxicity study is available for methoxychlor. However, this test is required only for
organophoshate coirpounds which inhibit cholinesterase. Methoxychlor is not an organophoshate, therefore, a study is
not required.
4/Ihese studies are not required since requirements for chronic rodent and nonrodent toxicity studies have been imposed
by the Agency.
5/Ihis study is not required because the registered use patterns of methoxychlor should not result in repeated dermal
contact.
Ł/This study is not required because the registered use patterns of methoxychlor should not result in repeated inhalation
exposure.
2/A progress report is due 12 months from receipt of this Standard. Interim reports are due annually thereafter.
Ł/Ihe study submitted by Kinkaid (MRID 159929) in response to the 1984 Agency DCI was reviewed and determined to be
unacceptable.
9/This requirement is reserved pending the results of other toxicity tests.
-------
74
Table A
Generic Data Requirements for Methoxychlor
Data Reouirement
Test Use
Substance Patterns
Does EPA
Have Data to
Satisfy This Bibliographic
Reouirement?
Citation
Must Additional
Data Be Submit-
ted Under FIFRA Timeframe
Section for
3(c)(2)(B)? Submission^/
Section 158.490 - Wildlife and Aquatic Organisms
Avian and Mammalian Testing
71-1 - Avian Single Dose
Oral LD50
71-2 - Avian Dietary LC5o
- Upland Game Bird
TGAI
TGAI
A,B,C,D,
A,B,C,D,
Yes
Yes
00160000
00022923
No
No
- Waterfowl TGAI
71-3 - Wild Mammal Toxicity TGAI
71-4 - Avian Reproduction
- Upland Game Bird TGAI
- Waterfowl TGAI
71-5 - Simulated Field TEP
Testing for Birds
and Mammals
A,B,C,D,
G,
N/A
A,B,C,D,
G
A,B,C,D,
G
A,B,C,D,
G
Yes
00229213
No
NO
NO
No
Yes
Yes
24 Months
(12 Months -
Progress Report)
24 Months
(12 Months -
Progress Report)
Reserved^/
-------
75
Tattle A
Generic Data Requirements for Methoxychlor (cont'd)
Does EPA
Have Data to
Test Use Satisfy This Bibliographic
Data Requirement Substance Patterns Requirement? citation
Section 158.490 - Wildlife and Aquatic Ora
ranisms
Must Additional
Data Be Submit-
ted Under FIFRA Timef rame
Section for
3(c)(2HB)? Submission!
Avian and Mammalian Testing (cont'd)
71-5 -
Aquatic
72-1 -
72-2 -
Actual Field Testing TEP
for Birds and
Mammals
Organism Testing
Freshwater Fish LC50
- Warmwater TGAI
TEP
- Coldwater TGAI
TEP
Freshwater TGAI
Invertebrate LC5Q
TEP
A,B,C,D, No
G
A,B,C,D, Yes 40098001
A[B,C,D, Partially 40098001
G
A,B,C,D, . Yes 40098001
A'B,C,D, Partially 40098001,
G 00098800
A,B,C,D, Yes 40098001
A,B,C,D, NO
G
Reserved^/
No
Yes^/ 9 Months
No
Yes3./ 9 Months
No
Yes 9 Months
-------
76
Table A
Generic Data Reqairements for Methaxycnlor (cont'd)
Data Requirement
Section 158.490 - Wildlife and
Aquatic Organism Testing cont'
72-3 - Estuarine and Marine
Organisms LCso
- Fish
- Shrimp
- Oyster
Does EPA
Have Data to
Test Use Satisfy This Bibliographic
Substance Patterns Reouirement? Citation
. Aouatic Organisms
d)
TGAI A,B,C,D, Yes 40228401
G
TEP A,B,C,D, NO
G
TGAI A,B,C,D, Yes 40228401
G
TEP A,B,C,D, NO
G
TGAI A,B,C,D, Yes 40228401
G
TEP A,B,C,D, NO
G
Must Additional
Data Be Submit-
ted Under FIFRA Timef rame
Section for
3(cH2HB)? Submission!
No
Yes 12 Months
No
Yes 12 Months
No
Yes 12 Months
72-4 - Fish Early Life Stage
and Invertebrate
Life Cycle
- Fish
TGAI
A,B.C,D,
NO
Yes
15 Months
- Invertebrates
TGAI
A,B.C,D,
No
Yes
15 Months
-------
77
Table A
Generic Data Requirements for Methoxychlor (cont'd)
Data Reouirement
Test Use
Substance Patterns
Does EPA
Have Data to
Satisfy This
Reoui rement?
Bibliographic
Citation
Must Additional
Data Be Sutmit-
ted Under FIFRA Timeframe
Section for
3(c)(2)(B)? Submissionl/
Section 158.490 - Wildlife and Aouatic Oraanisms
Aquatic Organism Testing cont'd)
72-5 - Fish Life Cycle TGAI
72-6 - Aquatic Organism TGAI
Accumulation
(Fish)
72-7 - Simulated or Actual TEP
Field Testing
Aquatic Organisms
-Aquatic Residue Monitoring
or Mesocosm Study
A,B,C,D,
G
A,B,C,D,
G
A,B
No
NO
NO
Reserved5-/
24 Months
(Acceptable
Protocol - 90
Days; Progress
Report - 12
Months)
Section 158.540 Plant Protection Testing
TIER I
TGAI
122-1 - Seed Germination/
Seedling Emergence
122-1 - Aquatic Plant Growth
TGAI
C,D,G
NO
NO
Yes
9 Months
9 Months
-------
78
Table A
Generic Data Requirements for Methoxychlor (cont'd)
Data Requirement
Test Use
Substance Patterns
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
citation
Most Additional
Data Be Submit-
ted Under FIFRA Timeframe
Section for
3(c) (2) (B)? Submissionl/
Section 158.540 Plant Protection Testing (cont'd)
TIER II
123-1 - Seed Germination/ TGAI C,D,G
Seedling Emergence
No
Reserved2/
123-1
123-2
124-1
- Vegetative Vigor
- Aquatic Plant Growth
TIER III
- Terrestrial Field
TGAI
TGAI
TEP
C,D,G
C,D,G
C,D,G
NO
NO
NO
Reserved2*/
Reserved^/
Reserved^/
I/Due dates refer to number of months following receipt of this Registration Standard, unless otherwise indicated.
2/The requirement is reserved pending the results of the required avian reproduction studies.
3/A typical emulsifiable concentrate formulation is required to support crop and aquatic uses. The requirement for
a granular formulation (up to 50%) has been satisfied.
4/Required to support registration of the formulations applied to livestock, as the treated livestock may move into
waterways .
5_/This requirement is reserved pending the results of the fish early life stage and aquatic invertebrate life cycle
6/Data are not required since the data required under Section 158.290 Environmental Fate (165-4) may be used to satisfy
this requirement.
2/Aquatic residue monitoring studies are required to be conducted in aquatic environments for aquatic uses. As an
alternative, a mesocosm study may be conducted. Monitoring studies are reserved for terrestrial uses depending upon
results of better estimation of aquatic EECs through modeling. If aquatic residue monitoring studies show aquatic
concentrations greater than 0.6 ppb, then mesocosm studies are required for the aquatic uses. Mesocosm testing for
-------
79
Table A
Generic Data Requirements for Methoxychlor (cont'd)
Section 158.540 Plant Protection Testing
terrestrial uses are reserved pending better refinement of aquatic EECs from modeling. Additionally, full field
studies for other use patterns are reserved pending an evaluation of the results from the above studies and an
analysis of their applicability to support other uses. For either mesocosm or full field studies, the study design
must include appropriate techniques to determine acute mortality and effects on productivity and diversity of fish
and aquatic invertebrates. Protocols for conducting residue monitoring, mesocosm, or full field studies must be
submitted to the Agency. A Guidance Document is available from the Agency that outlines an acceptable approach to
mesocosm studies. This document also provides relevant, although general, guidance for full field studies, which, if
selected in place of mesocosm studies, must include multiple treated ponds and control ponds.
S/Qnly the algae seignasi-rnm capricornutum is required initially. Based on results of this study, the testing of
additional species may be required.
2/This requirement is reserved pending results of Tier I studies.
IQ/This requirement is reserved pending results of Tier II studies.
-------
80
Table A
Generic Data Requirements for Methoxychlor
Data Reouirement
Test
Substance
Use
Patterns
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submit-
ted Under FIFRA Timeframe
Section for
3(c)(2HB)? Submission!/
Section 158.590 Nontarcet Insects
Nontaraet Insect Testing - Pollinators
141-1 - Honey Bee Acute TGAI
Toxicity
141-2 - Honey Bee - Toxicity TEP
of Residues on
Foliage
141-4 - Honey Bee Subacute Reserved^/
Feeding Study
141-5 - Field Testing for TEP
Pollinators
Nontaraet Insect Testing - Aquatic Insects
142-1 - Acute Toxicity to Reserved3-/
Aquatic Insects
142-2 - Aquatic Insect Life Reserved3-/
Cycle Study
142-3 - Simulated or Actual Reserved3-/
Field Testing for
Aquatic Insects
A,B,G
A,B,G
A,B,G
Yes
00036935
NO
NO
-------
81
Table A
Generic Data Requirements for Meihoxychlor (cont'd)
Data Requirement
Test Use
Substance Patterns
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submit-
ted Under FIFRA
Section
3(c)(2HBl?
Timeframe
for
Submission!/
Section 158.590 Nbntarget Insects
Nbntaraet Insect Testina - Predators and Parasites
143-1
thru
143-3
Reserved3-/
I/Due dates refer to the number of months following receipt of this Registration Standard, unless otherwise indicated.
2/As data from the acute contact test indicate low toxicity, no further testing is required.
.3/This requirement is reserved pending development of test methodology and/or decisions as to whether data should be
required.
-------
82
Table B
Product-Specific Data Requirements for Manufacturing-Use Products Containing Methoxychlor
Data Requirement
Test I/ Use
Substance Patterns
Does EPA
Have Data to
Satisfy This
Requjrement?2/
Bibliographic
CitationZ/
Must Additional
Data Be Submit-
ted Under FIFRA
Section
3(0(2) (Bl?
Timeframe
for
Submissions/
Part 158. Subpart C - Product Chemistry
Product Identity and Composition
61-1 - Product Identity and MP All
Disclosure of
Ingredients
61-2 - Description of Beginning MP All
Material and
Manufacturing Process
61-3 - Discussion of Formation MP All
of Impurities
Analysis and Certification of Product Inoredients
Yes6-/
62-1 - Preliminary Analysis of MP
Product Samples
62-2 - Certification of MP
Ingredient Limits
62-3 - Analytical Methods to MP
Verify Certified
Limits
Physical and Chemical Characteristics
63-2 - Color MP
63-3 - Physical State MP
All
All
All
Yes9-/
All
All
Yes
Yes
9 Months
9 Months
9 Months
12 Months
12 Months
12 Months
9 Months
9 Months
-------
83
Table B
Product-Specific Data Requirements for Manufacturing-Use Products Containing Methoxychlor
Data Reouirement
Part 158 . Subpart C - Product
Test I/ Use
Substance Patterns
Chemist rv
/f Must Additional
Does EPA Data Be Submit-
Have Data to ted Under FIFRA
Satisfy This Bibliographic Section
Reouirement?2/ CitationZ/ 3(c)(2)(B)?
Timeframe
for
Submissions
Physical and Chemical Characteristics (cont'd)
63-4 - Odor
63-7 - Density, Bulk Density
or Specific Gravity
63-12 - pH
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
Other Requirements
MP
, MP
MP
MP
MP
MP
MP
MP
MP
MP
Yes
Yes
YesW
Yesll/
Yesl2/
YeslS/
Yes
Yesl4/
yes15y
Yes
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
15 Months
9 Months
9 Months
15 Months
64-1 - Sutmittal of Samples
MP
All
Reserved^/
-------
84
Table B
Product-Specific Data Requirements for Manufacturing-Use Products Containing Methoxychlor
Part 158. Subpart C - Product Chemistry Footnotes
I/Formulation intermediates are also included in the category of manufacturing-use products (MPs).
^/Although product chemistry data may have been submitted in the past, the Agency has determined that these data must be
resubmitted for each MP. New requirements have been introduced and previously submitted data must be updated.
Therefore, bibliographic citations for the old data are not applicable.
3/Due dates refer to the number of months following receipt of this Registration Standard by the registrant, unless
otherwise indicated.
4/For each MP that consists of the technical grade of the active ingredient (TGAI) only or is produced by an integrated
system, the following information must be provided: (i) the CAS-approved chemical name, CAS Registry Number, any
common names, the nominal concentration, upper and lower certified limits in accordance with 40 CFR 158.175, and the
purpose of each active and inert ingredient in the product; (ii) the molecular, structural and empirical formulae, and
the molecular weight or weight range of each active ingredient in the product; (iii) the chemical name and nominal
concentration of each impurity of toxicological significance associated with the active ingredient or present in any
sample at a level equal to or greater than 0.1% by weight of the TC2J; and (iv) sufficient information to enable the
Agency to identify the source and qualitative composition of all ingredients that are not characterized. Impurities
must be identified as such. For each MP that is produced from an EPA-registered product, the following information
must be provided: (i) the chemical and common name of each active ingredient as listed on the source product, its
nominal concentration in the product based upon the nominal concentration in the source product, and upper and lower
certified limits in accordance with 158.175; (ii) the CAS-approved chemical name of each inert ingredient in the
product, its CAS Registry Number, any common names, nominal concentration, purpose, and upper and lower certified
limits in accordance with 158.175; and (iii) sufficient information to enable the Agency to identify the source and
qualitative composition of all ingredients that cannot be characterized.
5/For each MP that is produced from an EPA-registered product, the following information must be provided: (i) the name
and EPA Registration Number of the EPA-registered product; (ii) the brand name, trade name, or other commercial
designation and information concerning the composition of each inert ingredient; (iii) a general characterization of
the formulation or product process (e.g., batch or continuous); (iv) the identity of the materials used to produce the
product, their relative amounts, and the order in which they are added; (v) a description of the equipment used; (vi)
a description of the conditions (e.g., temperature, pressure, pH, humidity) that are controlled during each step of
the process; and (vii) a description of the procedures used to assure consistent composition of the substance produced
(quality control methods). For each MP that consists of the TGAI only or is produced by an integrated system, the
following information must be provided in addition to that listed above: (i) the name and address of the producer if
different from the registrant; (ii) the brand name, trade name or other commercial designation of each starting
material, the name and address of its producer, and information concerning its composition; (iii) a flow chart of the
chemical equations of each intended reaction occurring at each step of the process and of the entire process; and (iv)
-------
85
Table B
Product-Specific Data Requirements for Manufacturing-Use Products Containing Methoxychlor
Part 158. Subpart c - Product Chemistry Footnotes (cont'd)
Ł/For each MP product that consists of the TGAI only or is produced by an integrated system, a discussion regarding the
following potential impurities must be provided: (i) each impurity associated with the active ingredient which was
found to be present in any analysis of the product conducted by or for the registrant, and (ii) each impurity which
the registrant has reason to believe may be present in the produdt at a level equal to or greater than 0.1% (w/w)
based on the composition of each starting material, intended and/side reactions which may occur in the production of
the product, the possible degradation of ingredients in the product after production, postproduction reactions between
the ingredients in the product, possible contamination from packaging materials or production equipment, and process
control, purification and quality control measures. For each MP that is produced from an EPA-registered product, a
discussion must be provided for each impurity associated with the active ingredient which the registrant has reason to
believe may be present in the product at a level equal to or greater than 0.1% (w/w) based on the possible carryover
of impurities present in the registered product which serves as the source of the active ingredient, the possible
carryover of impurities present in the inert ingredients in the product, possible reactions occurring during the
formulation of the product, postproduction reactions between any of the product's active ingredients and any other^
component of the product or its packaging, and possible contamination from packaging materials or production equipment.
I/For each MP produced by an integrated system, the registrant must provide preliminary analyses of five or more
representative samples of each TGAI contained in the product to identify all impurities present at 0.1% or greater of
the TGAI. Specific analysis for the potential impurities l-chlor-l,2,2-tris(p-methoxyphenyl)ethylene (TACE), 1,1,1-
trichloro-2,2-bis(p-chlorophenyl)ethane (DDT), and its structurally similar compounds must be performed. If the
product is produced by a batch process, at least five separate batches should be represented. The preliminary
analysis should be conducted at the point in the production process after which no further chemical reactions designed
to produce or purify the substance are intended. Complete and detailed descriptions of the methods used for sample
analysis must be submitted, including statements of their precision and accuracy. The preliminary analysis report
should include the identity and quantity of each ingredient for which analysis is conducted, along with the mean and
relative standard deviation of the analytical -results. Based on the preliminary analysis, a statement of the
composition of the TGAI must be provided. If the TGAI cannot be isolated, a statement of the composition of the
practical equivalent of the TGAI must be submitted.
8/The registrant must propose upper and lower limits for each active and inert ingredient, if such limits would differ
from the standard certified limits determined by the Agency according to 40 CFR 158.175(b)(2). Also, if the MP
contains the TGAI only or is produced by an integrated system, upper limits must be proposed for each toxicologically
significant impurity associated with the active ingredients and found to be present in any sample of the product
(standard certified limits cannot be used for impurities). Certified limits should be based on the sources and
magnitude of variability in the manufacturing process and the stability of the ingredients following production.
-------
86
Table B
Product-Specific Data Requirements for Manufacturing-Use Products Containing Metnoxychlor
The registrant must certify the accuracy of the information presented, and that the certified limits will be
maintained. An explanation of how each certified limit was established (e.g., sample analysis using a validated
analytical procedure, quantitative estimate based on the amounts of ingredients used, etc.) must be provided, along
with information on the accuracy and precision of any analytical procedures used. Certifications must be submitted on
EPA Form 8570-4 (Rev. 2/85).
2/Analytical methods which are suitable for enforcement purposes must be provided for each active ingredient and each
additional ingredient or impurity that is determined to be toxicologically significant. Suitability for enforcement
purposes shall be determined from validation studies of method accuracy and precision submitted by the registrant.
IQ/Data on pH are required if the test substance is dispersible in water.
11/Data are required on oxidizing/reducing potential if product contains an oxidizing or reducing agent.
12/Data are required on flammability if the product contains combustible liquids.
13/Data are required if the product is potentially explosive.
14/Data on viscosity are required if the product is a liquid.
15./Data on miscibility are required if the product is an emulsifiable liquid and is to be diluted with petroleum
solvents.
16/1 f samples are needed, the Agency will request them.
-------
87
Table B
Product-Specific Data Requirements for Manufacturing-Use Products Containing Methoxychlor
Data
Reciui r ernent
Test
Substance
Use
Patterns
Does EPA.
Have Data to
Satisfy This Bibliographic
Reouirement? Citation
Must Additional
Data Be Submit-
ted Under FIFRA
Section
3(cH2HB)?
Section 158.340 Toxicology
Timeframe
for
Submissionl/
Acute Testing
81-1
81-2
81-3
81-4
81-5
81-6
- Acute Oral - Rat
- Acute Dermal
- Acute Inhalation - Rat
- Eye Irritation - Rabbit
- Dermal Irritation
- Rabbit
- Dermal Sensitization
- Guinea Pig
MP2/
MP
MP
MP
MP
MP
All
All
All
All
All
All
f
No 1
NO '
NO
NO
NO
NO
Yes
Yes
Yes
Yes
Yes
Yes
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
I/Due dates refer to the number of months following receipt of this Registration standard by the registrant, unless
otherwise indicated.
2/Formulation intermediates are also included in the category of MPs.
-------
II. LABELING APPENDICES
88
-------
SUMMARY-1
LABEL CONTENTS
40 CFR 156.10 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 test. 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 156.10(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 156.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA
establishment number, preceded by the phrase "EPA Est." is
the final establishment 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 156.10(f)]
89
-------
SUMMARY-2
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 156.10(g)]
Item 6B. POUNDS PER GALLON STATEMENT - For liquid
agricul- tural formulations, the pounds per gallon of active
ingredient must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front
panel precautionary statements must be grouped together,
preferably within a block outline. The table below shows the
minimum type size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point . 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with
children during distribution or use is unlikely.
[40 CFR 156.10(h)(l)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER,
WARNING, or CAUTION) is required on the front panel
immediately below the child hazard warning statement.
[40CFR 156.10(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 156.10(h)(l)(i)J.
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 156.10(h)(1)(iii)]
90
-------
SUMMARY- 3
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 156.10(h) (1) (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 156.10(h) (2) ]
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 156.10(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
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 S6C.
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.
91
-------
SUMMARY- 4
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 classification determination will
be evaluated in accordance with the provisions of 40 CFR
162. 11 (c). You will be notified of the Agency's
classification decision.
Classification inq Reuirements
If your product has been classified for restricted use,
the following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label.
The statement must be set in type of the same
minimum size as required for human hazard signal
word (see table in 40 CFR 156. 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.
92
-------
SUMMARY-5
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 simultaneously.
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.
Item 10A. REENTRY STATEMENT - If a reentry interval has
been established by the Agency, it must be included on the
label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983.
-------
SUMMARY-6
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 sue 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 156.10]
COLLATERAL
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.
-------
SIM1ARY-7
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
-
LARfTrf FJ.Fjtyfjvfi1
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
warnina)
Signal word
i
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage is
given as Its.
ai/unit area
All products
All products
All products
i 1
PLACEMENT
REOUTRjrp
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
i 1
rfl LTffflT,
PREFFRRFD
Center front
panel
Bottom front
panel or end
Qf 1i9bel text
Bottom front
panel or end
of label text
Front panel
Front panel
inmediately
before or
following
Rea. No.
Inmediately
following
Droduct name
Directly below
the main
ingredients
statement
Above signal
word
Inmediately
below child
hazard
warnina
QMffiNTS
If registrant is not the producer, must
be qualified by "Packed f or . . . ,"
"Distributed by . . . ," etc.
May be in metric units in addition to
U.S. units.
Must be in similar type size and run
pftra.llel 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.
95
-------
SUMMARY-8
S OF THE t'lEKA. AS
(cont'd)
1'itn
7C
7D
7E
8
'
8A
8B
U\RFT. IT.TJT^Fj^I1
Skull & cross-
bones and word
POISCN (in red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
jp^Trts
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
PLACEMFiyr
i^FFCHJT RF1 ) 1
Front panel
Cateaory I:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precautionary
statements .
Front panel
None
None
None
ON LABEL
tffr'iHiHPfcH '
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
L COMMENTS
Must be grouped under headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
-------
HAIAAM ID HUMANS
• fiOUMIBANMALt
CAUTION
•MVTCMMNTAtMAlAMM
NAIAMt
•
MMMINV ftAlfUINI
CHOH
PRODUCT
NAME
A01WI MMfOOffi ,
ft
ft
TOTAU
tOOttft
IM or
KEEP OUT OF REACH OF CHILDREN
CAUTION
•TAifUMT or PAAcncAt
PIWAUC
FMUUI
Ml MM rAMt POM
PMOAUnONAMV tTAItUINn
uratri
towN.tr ATI:
llfAMJIHUIfirNO.:
MITI
97
STORAGE AND
DISPOSAL
WAMUNfYfTATOyKNI
-------
PNtCAUnONAMV tTATEMf NT!
HAZAMM TO HUMAI*
K DOMf m ANMM4I
OAMOCM
IMVmOMUtNTM. MAIAKtt
OMOTON8PON UN
I * •
-------
40 CFR Ch. I (7-1-87 Edition)
§ 02.10 Labeling requirements.
(a) General—(1) Contents of the
label Every pesticide products shall
bear a label containing the informa-
tion specified by the Act and the regu-
lations in this Part. The contents of a
label must show clearly and promi-
nently the following:
(i) The name, brand, or trademark
under which the product is sold as pre-
99
-------
.scribed in paragraph (b) of this sec-
tion:
(ii) The name and address of the
producer, registrant, or person for
whom produced as prescribed in para-
graph (c) of this section:
(iii) The net contents as prescribed
in paragraph (d) of this section:
(iv) The product registration
number as prescribed in paragraph (e)
of this section:
(v) The producing establishment
number as prescribed in paragraph (f)
of this section:
(vi) An ingredient statement as pre-
scribed in paragraph (g) of this sec-
tion:
(vii) Warning or precautionary state-
ments as prescribed in paragraph (h)
of this section:
(viii) The directions for use as pre-
scribed in paragraph (i) of this section:
and
(ix) The use classifications) as pre-
scribed in paragraph (j) of this section.
(2) Prominence and legibility, (i) All
words, statements, graphic representa-
tions, designs or other information re-
quired on the labeling by the Act or
the regulations in this part must be
clearly legible to a person with normal
vision, and must be placed with such
conspicuousness (as compared with
other words, statements, designs, or
graphic matter on the labeling) and
expressed in such terms as to render it
likely to be read and understood by
the ordinary individual under custom-
ary conditions of purchase and use.
(ii) All required label text must:
(A) Be set in 6-point or larger type:
(B) Appear on a clear contrasting
background: and
(C) Not be obscured or crowded.
_ (3) Language to be used. All required
label or labeling text shall appear in
the English language. However, the
.Agency may require or the applicant
may propose additional text in other
languages as is considered necessary to
-protect the public. When additional
text in another language is necessary.
all labeling requirements will be ap-
plied equally to both the English and
other-language versions of the label-
ing.
(4) Placement of Label—(I) General
The label shall appear on or be secure-
ly attached to the immediate contain-
er of the pesticide product. For pur-
poses of this Section, and the mis-
branding provisions of the Act, "se-
curely attached" shall mean that a
label can reasonably be expected to
remain affixed during the foreseeable
conditions and period of use. If the im-
mediate container is enclosed within a
wrapper or outside container through
which the label cannot be clearly read.
the label must also be securely at-
tached to such outside wrapper or con-
tainer, if it is a part of the package as
customarily distributed or sold.
(ii) Tank cars and other bulk con-
tainers—(A) Transportation. While a
pesticide product is in transit, the ap-
propriate provisions of 49 CFR Parts
170-189. concerning the transportation
of hazardous materials, and specifical-
ly those provisions concerning the la-
beling, marking and placarding of haz-
ardous materials and the vehicles car-
rying them, define the basic Federal
requirements. In addition, when any
registered pesticide product is trans-
ported in a tank car. tank truck or
other mobile or portable bulk contain-
er, a copy of the accepted label must
be attached to the shipping papers.
and left with the consignee at the time
of delivery.
"(B) Storage. When pesticide prod-
ucts are stored in bulk containers.
whether mobile or stationary, which
remain in the custody of the user, a
copy of the label of labeling, including
all appropriate directions for use. shall
be securely attached to the container
in the immediate vicinity of the dis-
charge control valve.
(5) False or misleading statements.
Pursuant to section 2(q)(l)(A) of the
Act. a pesticide or a device declared
subject to the Act pursuant to
§ 162.15. is misbranded if its labeling is
false or misleading in any particular
including both pesticidal and non-pes-
ticidal claims. Examples of statements
or representations in the labeling
which constitute misbranding include:
(i) A false or misleading-Statement
concerning the composition of the
product:
(ii) A false or misleading statement
concerning the effectiveness of the
product as a pesticide or device:
(iii) A false or misleading statement
about the value of the product for
too
-------
§ 162.10
40 CFR Ch. I (7-1-87 Edition)
purposes other than as a pesticide or
device:
(iv) A false or misleading comparison
with other pesticides or devices;
(v) Any statement directly or indi-
rectly implying that the pesticide or
device is recommended or endorsed by
any agency of the Federal Govern-
ment:
(vi) The name of a pesticide which
contains two or more principal active
ingredients if the name suggests one
or more but not all such principal
active ingredients even though the
names of the other ingredients are
stated elsewhere in the labeling:
(vii) A true statement used in such a
way as to give a false or misleading im-
pression to the purchaser;
(viii) Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions;
(ix) Claims as to the safety of the
pesticide or its ingredients, including
statements such as "safe." "nonpoison-
ous." "noninjurious." "harmless" or
"nontoxic to humans and pets" with
or without such a qualifying phrase as
"when used as directed"; and
(x) Non-numerical and/or compara-
tive statements on the safety of the
product, including but not limited to:
(A) "Contains all natural ingredi-
ents";
(B) "Among the least toxic chemi-
cals known"
(C) "Pollution approved"
(6) Final printed labeling, (i) Except
as provided in paragraph (a)(6)(ii) of
this section, final printed labeling
must be submitted and accepted prior
to registration. However, final printed
labeling need not be submitted until
draft label texts have been provision-
ally accepted by the Agency.
(ii) Clearly legible reproductions or
photo reductions will be accepted for
unusual labels such as those silk-
screened directly onto glass or metal
containers or large bag or drum labels.
Such reproductions must be of micro-
film reproduction quality.
(b) Name, brand, or trademark. (1)
The name, brand, or trademark under
which the pesticide product is sold
shall appear on the front panel of the
label. •
(2) No name, brand, or trademark
may appear on the label which:
(i) Is false or misleading, or
(ii) Has not been approved by the
Administrator through registration or
supplemental registration as an addi-
tional name pursuant to § 162.6(b)(4).
(c) Name and address of producer.
registrant, or person for whom pro-
duced. An unqualified name and ad-
dress given on the label shall be con-
sidered as the name and address of the
producer. If the registrant's name ap-
pears on the label and the registrant is
not the producer, or if the name of the
person for whom the pesticide was
produced appears on the label, it must
be qualified by appropriate wording
such as "Packed for • • '," "Distribut-
ed by • • V or "Sold by •" to show
that the name is not that of the pro-
ducer.
(d) Net weight or measure of con-
tents. (1) The net weight or measure
of content shall be exclusive of wrap-
pers or other materials and shall be
the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide is a liquid, the
net content statement shall be in
terms of liquid measure at 68* F (20*C)
and shall be expressed in conventional
American units of fluid ounces, pints,
quarts, and gallons.
(3) If the pesticide is solid or semi-
solid, viscous or pressurized, or is a
mixture of liquid and solid, the net
content statement shall be in terms of t
weight expressed as avoirdupois i
pounds and ounces.
(4) In all cases, net content shall be
stated in terms of the largest suitable
units, Le., "1 pound 10 ounces" rather
than "26 ounces."
(5) In addition to the required units
specified, net content may be ex-
pressed in metric units.
(6) Variation above minimtim con-
tent or around an average is permissi-
ble only to the extent that it repre-
sents deviation unavoidable in good
manufacturing practice. Variation ;
below a stated minimum is not permit-
ted. In no case shall the average con-
tent of the packages in a shipment fall
below the stated average content.
(e) Product registration number.
The registration number assigned to
the pesticide product at the time of
101
-------
Environmental Protection Agency
registration shall appear on the label.
preceded by the phrase "EPA Regis-
tration No.." or the phrase "EPA Reg.
ffo." The registration number shall be
set in type of a size and style similar to
other print on that part of the label
on which it appears and shall run par-
allel to it. The registration number
and the required identifying phrase
shall not appear in such a manner as
to suggest or imply recommendation
or endorsement of the product by the
Agency.
(f) Producing establishments regis-
tration number. The producing estab-
lishment registration number preced-
ed by the phrase "EPA Est.". of the
final establishment at which the prod-
uct was produced may appear in any
suitable location on the label or imme-
diate container. It must appear on the
wrapper or outside container of the
package if the EPA establishment reg-
istration number on the immediate
container cannot be clearly read
through such wrapper or container.
(g) Ingredient statement—(I) Gener-
al The label of each pesticide product
must bear a statement which contains
the name and percentage by weight of
each active ingredient, the total per-
centage by weight of all inert ingredi-
ents; and if the pesticide contains ar-
senic in any form, a statement of the
percentages of total and water-soluble
arsenic calculated as elemental ar-
senic. The active ingredients must be
designated by the term "active ingredi-
ents" and the inert ingredients by the
term "inert ingredients." or the singu-
lar forms of these terms when appro-
priate. Both terms shall be in the
same type size, be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" is
not required for pesticides which con-
tain 100 percent active ingredients.
Unless the ingredient statement is a
complete analysis of the pesticide, the
term "analysis" shall not be used as a
heading for the ingredient statement.
(2) Position of ingredient statement
(i) The ingredient statement is nor-
mally required on the front panel of
the label. If there is an outside con-
tainer or wrapper through which the
ingredient statement cannot be clearly
read, the ingredient statement must
also appear on such outside container
§ 162.10
or wrapper. If the size or form of the
package makes it impracticable to
place the ingredient statement on the
front panel of the label, permission
may be granted for the ingredient
statement to appear elsewhere.
(ii) The text of the ingredient state-
ment must run parallel with other
text on the panel on which it appears.
and must be clearly distinguishable
from and must not be placed in the
body of other text.
(3) Names to be used in ingredient
statement The name used for each in-
gredient shall be the accepted
common name, if there is one. fol-
lowed by the chemical name. The
common name may be used alone only
if it is well known. If no common name
has been established, the chemical
name alone shall be used. In no case
will the use of a trademark or proprie-
tary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of section 25(c)(6).
(4) Statements of percentages. The
percentages of ingredients shall be
stated in terms of weight-to-weight.
The sum of percentages of the active
and the inert ingredients shall be 100.
Percentages shall not be expressed by
a range of values such as "22-25%." If
the uses of the pesticide product are
expressed as weight of active ingredi-
ent per unit area, a statement of the
weight of active ingredient per unit
volume of the pesticide formulation
shall also appear in the ingredient
statement.
(5) Accuracy of stated percentages.
The percentages given shall be as pre-
cise as possible reflecting good manu-
facturing practice. If there may be un-
avoidable variation between manufac-
turing batches, the value stated for
each active ingredient shall be the
lowest percentage which may be
present.
(6) Deterioration. Pesticides which
change in chemical composition sig-
nificantly must meet the following la-
beling requirements:
(i) In cases where it is determined
that a pesticide formulation changes
chemical composition significantly,
the product must bear the following
statement in a prominent position on
102
-------
§ 162.10
the label: "Not for sale or use after
[date]."
(ii) The product must meet all label
claims up to the expiration time indi-
cated on the label.
(7) Inert ingredients. The Adminis-
trator may require the name of any
inert ingredient(s) to be listed in the
ingredient statement if he determines
that such ingredient(s) may pose a
hazard to man or the environment.
(h) Warnings and precautionary
statements. Required warnings and
precautionary statements concerning
the general areas of toxicological
hazard including hazard to children.
environmental hazard, and physical or
40 CFR Ch. I (7-1-87 Edition)
chemical hazard fall into two groups;
those required on the front panel of
the labeling and those which may
appear elsewhere. Specific require-
ments concerning content, placement,
type size, and prominence are given
below.
(1) Required front panel statements.
With the exception of the child
hazard warning statement, the text re-
quired on the front panel of the label
is determined by the Toxicity Catego-
ry of the pesticide. The category is as-
signed on the basis of the highest
hazard shown by any of the indicators
in the table below.
H«zard indicators
Oral L0«
Inhalation LC» —
Dermal LD*
Eye effects
Shin effects.
Toxicity categories
1
Up to and including 50
mg/kg.
Up to and including 2
mg/kttr.
Up to and including 200
mg/kg.
Corrosive: comeal
opacity not reversible
•tlnn 7 days.
COTOSFVt
II
From 50 thru 500 mg/kg..
From 2 tttfu 2 mg/bter
From 200 thru 2000
Comeal opacity
days: irritation
persisting lor 7 days.
Severe irritation at 72
noun.
ill
From 500 thru 5000 mg/
"g-
From 2. thru 20 mg/hter...
From 2.000 thru 20.000....
No comeal opacity;
irritation reversible
withtftTdays.
Moderate mutton at 72
hours.
IV
Greater than 5000 mg/
kg-
Greater than 20 mg/bter.
Greater than 20.000.
No vntaoon.
j
Mild or slight mtatwn at •
72 hours.
(i) Human hazard signal word—(.A)
Toxicity Category L All pesticide prod-
ucts meeting the criteria of Toxicity
Category I shall bear on the front
panel the signal word "Danger." In ad-
dition if the product was assigned to
Toxicity Category I on the basis of its
oral, inhalation or dermal toxicity (as
distinct from skin and eye local ef-
fects) the word "Poison" shall appear
in red on a background of distinctly
contrasting color and the_ skull and
crossbones shall appear in immediate
proximity to the word "poison."
(B) Toxicity Category II. All pesti-
cide products meeting the criteria of
Toxicity Category II shall bear on the
front panel the signal word "Warn-
ing." -
(C) Toxicity Category III. All pesti-
cide products meeting the criteria of
Toxicity Category III shall bear on
the front panel the signal word "Cau-
tion."
(D) Toxicity Category IV. AU pesti-
cide products meeting the criteria of
Toxicity Category IV shall bear on the
front panel the signal word "Caution."
(E) Use of signal words. Use of any
signal word(s) associated with a higher
Toxicity Category is not permitted
except when the Agency determines
that such labeling is necessary to pre-
vent unreasonable adverse effects on
man or the environment. In no case
shall more than one human hazard
signal word appear on the front panel
of alabeL
(ii) CTiiZd hazard warning. Every pes-
ticide product label shall bear on the
front panel the statement "keep out of
reach of children." Only in cases
where the likelihood of contact with
children during distribution, market-
ing, storage or use is demonstrated by _
the applicant to be extremely remote,
or if the nature of the pesticide is such
that it is approved for use on infants
or small children, may the Administra-
tor waive this requirement.
(lii) Statement of practical treat-
ment—
-------
Environmental Protection Agoncy
§ 162.10
statement of practical treatment (first
aid or other) shall appear on the front
panel of the label of all pesticides fall-
ing into Toxicity Category I on the
basis of oral, inhalation or dermal tox-
icity. The Agency may, however,
permit reasonable variations in the
placement of the statement of practi-
cal treatment is some reference such
as "See statement of practical treat-
ment on back panel" appears on the
front panel near the word "Poison"
and the skull and crossbones.
(B) Other toxicity categories. The
statement of practical treatment is not
required on the front panel except as
described in paragraph (hXIXiiiXA) of
this section. The applicant may. how-
ever, include such a front panel state-
ment at his option. Statements of
practical treatment are, however, re-
quired elsewhere on the label in
accord with paragraph (h>(2) of this
section if they do not appear on the
front panel.
(iv) Placement and prominence. All
the require front panel warning state-
ments shall be grouped together on
the label, and shall appear with suffi-
cient prominence relative to other
front panel text and graphic material
to make them unlikely to be over-
looked under customary conditions of
purchase and use. The following table
shows the minimum type size require-
ments for the front panel warning
statements on various sizes of labels:
Size of label front panel m square
inches
5 and under
Atwve 5 to 10
Above '0 to 15 , ,
Above 15 to 30 .,., „
rk^rV)
Poms
Required
signal
word, all
capitals
6
10
12
14
18
"Keep out
of reacn of
children"
6
6
8
10
12
(2) Other required warnings and pre-
cautionary statements. The warnings
and precautionary statements as re-
quired below shall appear together on
the label under the general heading
"Precautionary Statements" and
under appropriate subheadings of
"Hazard to Humans and Domestic Ani-
mals." "Environmental Hazard" and
"Physical or Chemical Hazard."
(1) Hazard to humans and domestic
animals. (A) Where a hazard exists to
humans or domestic animals, precau-
tionary statements are required indi-
cating the particular hazard, the
route(s) of exposure and the precau-
tions to be taken to avoid accident.
injury or damage. The precautionary
paragraph shall be immediately pre-
ceded by the appropriate hazard signal
word.
(B) The following table depicts typi-
cal precautionary statements. These
statements must be modified or ex-
panded to reflect specific hazards.
ToxiQty
category
tv_
Precautionary statements by toncrty category
Oral, inhalation, or dermal toncrty
Fatal (poisonous) if swallowed [inhaled or absorbed
through skin]. Do not breathe vapor [dust or spray
mist]. Do not get in eyes, on skin, or on doming
[Front panel statement of practical treatment re-
quired. 1.
May be fatal if swallowed [inhaled or absorbed
through the skm]. Do not breathe vapors [dust or
spray mist]. Do not get m eyes, on skm. or on
clothing. [Appropriate first aid statements required.].'
Harmful if swallowed [inhaled or absorbed through the
skin]. Avoid breathing vapors [dust or spray mist].
- Avoid contact with skin [eyes or dothmg]. (Appro-
priate first aid statement required.].
[No precautionary statements requred.]
Skm and eye local effects
Corrosive, causes eye and skin damage [or skm
irritation]. Do not get in eyes, on skin, or on
clothing. Wear goggles or face shield and rubber
gloves'when handling." Harmful or fatal if swallowed.
(Appropriate first aid statement requred.]
Causes eye [and skin] irritation. Do not get in eyes.
on skin, or on dothmg. Harmful it swallowed. [Ap-
propriate first aid statement requred.]
Avoid contact with skin, eyes or dothmg. In case of
contact immediately flush eyes or skin with plenty of
water. Get medical attention H irritation persists.
[No precautionary statements requred.]
(ii) Environmental hazards. Where a
hazard exists to non target organisms
excluding humans and domestic ani-
mals, precautionary statements are re-
quired stating the nature of the
hazard and the appropriate precau-
tions to avoid potential accident.
injury or damage. Examples of the
104
-------
(C) Warnings as required against use
on certain crops, animals, objects, or
in or adjacent to certain areas.
(D) [Reserved]
(E) For restricted use pesticides, a
statement that the pesticide may be
applied under the direct supervision of
a certified applicator who is not phys-
ically present at the site of application
but nonetheless available to the
person applying the pesticide, unless
the Agency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who is physically present.
(F) Other pertinent information
which the Administrator determines
to be necessary for the protection of
man and the environment.
(j) Statement of Use Classification.
By October 22,1976, all pesticide prod-
ucts must bear on their labels a state-
ment of use classification as described
in paragraphs (j) (1) and (2) of this
section. Any pesticide product for
which some uses are classified for gen-
eral use and others for restricted use
shall be separately labeled according
to the labeling standards set forth in
this subsection, and shall be marketed
as separate products with different
registration numbers, one bearing di-
rections only for general use(s) and
the other bearing directions for re-
stricted use(s) except that, if a product
has both restricted use(s) and general
use(s). both of these uses may appear
on a product labeled for restricted use.
Such products shall be subject to the
provisions of § 162.10
-------
Environmental Protection Agency
§ 162.10
lions for use may be omitted from la-
beling of pesticides which are intended
for use only by manufacturers of prod-
ucts other than pesticide products in
their regular manufacturing processes,
provided that:
(1) The label clearly shows that the
product is intended for use only in
manufacturing processes and specifies
the type(s) of products involved.
(2) Adequate information such as
technical data sheets or bulletins, is
available to the trade specifying the
type of product involved and its
proper use in manufacturing process-
es;
(J) The product will not come into
the hands of the general public except
after incorporation into finished prod-
ucts; and
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(B) Detailed directions for use may
be omitted from the labeling of pesti-
cide products for which sale is limited
to physicians, veterinarians, or drug-
gists, provided that:
(1) The label clearly states that the
product is for use only by physicians
or veterinarians:
(2) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment; and
(3) The product is also a drug and
regulated under the provisions of the
Federal Food. Drug and Cosmetic Act.
(C) Detailed directions for use may
be omitted from the labeling of pesti-
cide products which are intended for
use only by formulators in preparing
pesticides for sale to the public, pro-
vided that:
(J) There is information readily
available to the formulators on the
composition, toxicity. methods of use.
applicable restrictions or limitations.
and effectiveness of the product for
pesticide purposes:
(2) The label clearly states that the
product is intended for use only in
manufacturing, formulating, mixing,
or repacking for use as a pesticide and
specifies the type(s) of ^pesticide prod-
ucts involved: ~"
(J) The product as finally manufac-
tured, formulated, mixed, or repack-
aged is registered: and
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(2) Contents of Directions for Use.
The directions for use shall include
the following, under the headings "Di-
rections for Use":
(i) The statement of use classifica-
tion as prescribed in 162.10(j) immedi-
ately under the heading "Directions
for Use."
(ii) Immediately below the state-
ment of use classification, the state-
ment "It is a violation of Federal law
to use this product in a manner incon-
sistent with its labeling."
(iii) The site(s) of application, as for
example the crops, animals, areas, or
objects to be treated.
(iv) The target pest(s) associated
with each site.
(v) The dosage rate associated with
each site and pest.
(vi) The method of application, in-
cluding instructions for dilution, if re-
quired, and type(s) of application ap-
paratus or equipment required.
(vii) The frequency and timing of ap-
plications necessary to obtain effective
results without causing unreasonable
adverse effects on the environment.
(viii) Specific limitations on reentry
to areas where the pesticide has been
applied, meeting the requirements
concerning reentry provided by 40
CFR Part 170.
(ix) Specific directions concerning
the storage and disposal of the pesti-
cide and its container, meeting the re-
quirements of 40 CFR Part 165. These
instructions shall be grouped and
appear under the heading "Storage
and Disposal." This heading must be
set in type of the same minimum sizes
as required for the child hazard warn-
ing. (See Table in § 162.10(h)(l)(iv))
(x) Any limitations or restrictions on
use required to prevent unreasonable
adverse effects, such as:
(A) Required intervals between ap-
plication and harvest of food or feed
crops.
(B) Rotational crop restrictions.
06
-------
§ 162.10
40 CFR Ch. I (7-1-87 Edition)
hazard statements and the circum-
stances under which they are required
follow:
(A) If a pesticide intended for put-
door use contains an active ingredient
with a mammalian acute oral LD» of
100 or less, the statement "This Pesti-
cide is Toxic to Wildlife" is required.
(B) If a pesticide intended for out-
door use contains an active ingredient
with a fish acute LC» of 1 ppm or less.
the statement "This Pesticide is Toxic
to Fish" is required.
(C) If a pesticide intended for out-
door use contains an active ingredient
with an avion acute oral LDM of 100
mg/kg or less, or a subacute dietary
LCW of 500 ppm or less, the statement
"This Pesticide is Toxic to Wildlife" is
required.
(D) If either accident history or field
studies demonstrate that use of the
pesticide may result in fatality to
birds, fish or mammals, the statement
"This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) For uses involving foliar applica-
tion to agricultural crops, forests, or
shade trees, or for mosquito abate-
ment treatments, pesticides toxic to
pollinating insects must bear appropri-
ate label cautions.
(F) For all outdoor uses other than
aquatic applications the label must
bear the caution "Keep out of lakes,
ponds or streams. Do not contaminate
water by cleaning of equipment or dis-
posal of wastes."
(iii) Physical or chemical hazards.
Warning statements on the flammabil-
ity or explosive characteristics of the
pesticide are required as follows:
Flash pomt
Hequred text
(A) PnessumzEO CONTAMCMS
Flash pom at or Mow 20* F; A there « a flashback at
any valve opening.
Flash pomt above 20* F and not over 80* F or if the
flame extension * more than 18 in long at a distance
Of 6 M from the flame.
All other pressurized containers
Extremely flammable. Contents under pressure. Keep away from
fire, sparks, and heated surfaces. Do not puncture or monerate
container. Exposure to temperatures above 130* F may cause
bursting.
Flammable. Contents under pressure. Keep away (ram heat
sparks, and open flame. Do not puncture or tnonerate comaker.
Exposure to temperatures above 130* F may cause burstmg.
Contents under pressure. Do not use or store near heat or open
flame. Do not puncture or inonerate container. Exposure to
temperatures above 130* F may cause bursting.
(B) NONMESSumzEO CONTMNCMS
Above 20* F and not
80* F_
F and not over 150* F.
Extremely flammable. Keep away from fire, sparks, and heated
Flammable. Keep away from heat and open flame.
Do not use or store near heat or open flame.
(1) Directions for Use—(1) General
requirements--
-------
PHYSICAL-CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A.
Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B.
Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
ALL OTHER PRESSURIZED
CONTAINERS
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire,
sparks, and heated
surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents
under pressure. Keep
away from heat, sparks,
and flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do
not puncture or incine-
rate container. Exposure
to temperatures above
130°F may cause bursting.
Ext r erne ly f 1 ainmab 1 e.
Keep away from fire,
sparks, and heated
surfaces.
Flammable, keep away
from heat and open flame.
Do not use or store near
heat and open flame.
None required.
i tfs:
-------
STOR-1
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading;
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of the
label under the heading STORAGE AND DISPOSAL. Products intended
solely for domestic use need not include the heading "STORAGE AND
DISPOSAL."
Storage Instructions;
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction*
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure while
opening or closing container.
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been spilled,
and precautions to minimize exposure if damage occurs.
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides during
storage to prevent cross-contamination of other pesticides,
fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
-------
PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal. The statements listed below contain the exact wording
that must appear on the label of these products:
1. The labels of all products, except domestic use, must
contain the statement, "Do not contaminate water, food, or feed
by storage or disposal."
2. Except those products intended solely for domestic use, the
labels of all products that contain active ingredients that are
Acute Hazardous Wastes or are assigned to Toxicity Category I on
the basis of oral or dermal toxicity, or Toxicity Category I or
II on the basis of acute inhalation toxicity must bear the
following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal
of excess pesticide, spray mixture, or rinsate is a
violation of Federal Law. If these wastes cannot be
disposed of by use according to label instructions, contact
your State Pesticide or Environmental Control Agency or the
Hazardous Waste representative at the nearest EPA Regional
Office for guidance."
3. The labels of all products, except those intended for
domestic use, containing active or inert ingredients that are
Toxic Hazardous Wastes or meet any of the criteria in 40 CFR 261,
Subpart C for a hazardous waste must bear the following pesticide
disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of
Federal Law. If these wastes cannot be disposed of by use
according to label instructions, contact your State
Pesticide or Environmental Control Agency, or the Hazardous
Waste representative at the nearest EPA Regional Office for
guidance."
4. Labels for all other products, except those intended for
domestic use, must bear the following pesticide disposal
statement:
"Wastes resulting from the use of this product may be
disposed of on site or at an approved waste disposal
facility."
5. Products intended for domestic use only must bear the
following disposal statement: "Securely wrap original container
in several layers of newspaper and discard in trash."
no
-------
CONT/DIS-1
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. Domestic use products must bear one of the following
container disposal statements:
Container Type
Statement
Non-aerosol products JDo not reuse container (bottle, can, jar).
(bottles, cans. iars)!Rinse thoroughly before discarding in trash.
Non-aerosol products
(bags)
|Do not reuse bag. Discard bag in trash.
Aerosol products
1 Replace cap and discard containers in
!trash. Do not incinerate or puncture.
2. All other products must bear container disposal
instructions, based on container type, listed below:
Container Type
Statement
Metal
containers
(non-aerosol)
[Triple rinse (or equivalent). Then offer
[for recycling or reconditioning, or puncture
[and dispose of in a sanitary landfill, or by
[other procedures approved by state and local
!authorities.
Plastic containers
[Triple rinse (or equivalent). Then offer
[for recycling or reconditioning, or puncture
[and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
If burned,
[local authorities, by burning.
!stay out of smoke.
Glass containers
[Triple rinse (or equivalent). Then dispose
[of in a sanitary landfill or by other
!approved state and local procedures.
Fiber drums
with liners
Paper and
plastic bags
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused—/, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Compressed gas
cylinders
[Return empty cylinder for reuse (or
'.similar wording).
-"-/ Manufacturer may replace this phrase with one indicating whether
and how fiber drum may be reused.
-------
IV. BIBLIOGRAPHY APPENDICES
-------
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)(4) below for a further explanation. 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.
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.
113
-------
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 following 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.
114
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methoxychlor Standard
MRID Citation
00022923 Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary
Toxicities of Environmental Pollutants to Birds: Special Scien-
tific Report—Wildlife No. 191. (U.S. Dept. of the Interior,
Fish and Wildlife Service, Patuxent Wildlife Research Center;
unpublished report)
00025687 Claborn, H.V.; Radeleff, R.D.; Nickerson, W.J.; et al. (1956) In-
secticide Residues in Meat and Milk: ARS-33-25. (Unpublished
study received Nov 5, 1970 under 1F1060; prepared by U.S. Agri-
cultural Research Service, Animal Disease and Parasite Research
Branch and Entomology Research Branch, submitted by Velsicol
Chemical Corp., Chicago, 111.; CDL:099195-AN)
00028625 Simmon, V.F. (1979) In vitro Microbiological Mutagenicity and Un-
scheduled DNA Synthesis Studies of Eighteen Pesticides: Report
No. EPA-600/1-79-041. (Unpublished study including submitter
summary, received Apr 3, 1980 under 279-2712; prepared by SRI
International, submitted by FMC Corp., Philadelphia, Pa.; CDL:
099350-A)
00036935 Atkins, E.L., E.A. Greywood, and R.L. Macdonald (1975) Toxicity of
Pesticides and Other Agricultural Chemicals to Honey Bees,
Laboratory Studies, Univ. of California, Div. Agric. Sci., Leaflet
2287. 38 pp.
00062704 Henry, J.E.; Culik, R.; Hostetler, J.A.; et al. (1976) Teratogenic
Study in Rats with ethane,!,1,l-Trichloro-2,2-bis/para-meth-
oxyphenyl/-[sic] (Methoxychlor) IN-5099: Haskell Laboratory Re-
port No. 648-76. (Unpublished study received Oct 8, 1976 under
352-75; submitted by E.I. du Pont de Nemours & Co., Wilmington,
Del.; CDL:226715-A)
00070728 Olney, C.E.; Donaldson, W.E.; Kerr, T.W. (1962) Methoxychlor in
eggs and chicken tissues. Journal of Economic Entomology
55(4):477-479. (Also in unpublished submission received Feb
2, 1981 under 9E2165; submitted by Interregional Research
Project No. 4, New Brunswick, N.J.; CDL:099908-B)
00070729 Thompson, E.M.; Mountney, G.J. ; Ware, G.W. (1967) Methoxychlor
residues in chicken eggs. Journal of Economic Entomology
60(1):235-237. (Also in unpublished submission received Feb
2, 1981 under 9E2165; submitted by Interregional Research
Project No. 4, New Brunswick, N.J.; CDL:099908-C)
115
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methoxychlor Standard
MRID Citation
00089064 Biddulph, C.; Bateman, G.Q.; Harris, J.R.; et al. (1952) Effect of
feeding methoxychlor-treated alfalfa hay to dairy cows. Journal
of Dairy Science XXXV(5):445-448. (Also in unpublished submis-
sion received Jul 29, 1955 under PP0035; submitted by E.I. du
Pont de Nemours & Co., Inc., Wilmington, Del.; CDL:090097-D)
00089808 American Cyanamid Company (1957) [Residues of Insecticides—Grain].
(Compilation; unpublished study received Apr 10, 1957 under
PP0136; CDL:090164-B)
00093382 E.I. du Pont de Nemours & Company, Incorporated (1967) Results of
Tests on the Amount of Residue Remaining on Treated Crops:
[Maneb]. (Compilation; unpublished study, including published
data, received Feb 20, 1967 under 7F0563; CDL:090708-A)
00097051 E.I. du Pont de Nemours & Company, Incorporated (1950) Testimony
of G. Dragt: Analytical Methods. (Compilation; unpublished
study received May 24, 1960 under unknown admin, no.; CDL:
130674-A)
0009'8800 McCann, J.A. (1971) [Orthocide Methoxychlor 75-3: Rainbow Trout
(Salmo gairdneri)]: Test No. 426. (U.S. Agricultural Re-
search Service, Pesticides Regulation Div., Animal Biology
Laboratory; unpublished study; CDL:108542-A)
00105471 Reno, P. (1957) Letter sent to Pesticide Branch, Food & Drug Ad-
ministration, Dept. of Health, Education & Welfare dated Mar 1,
1957 [Efficacy of toxaphene]. (Unpublished study received
Mar 4, 1957 under PP0114; submitted by Hercules Powder Co.,
Inc., Wilmington, DE; CDL:092396-A)
00108733 E.I. du Pont de Nemours & Co., Inc. (1967) [Methoxychlor: Residues
in Potatoes and Other Crops]. (Compilation; unpublished study
received Jun 7, 1968 under 8F0680; CDL:091187-D)
00113268 E.I. du Pont de Nemours & Co., Inc. (1959) [Methoxychlor Residues
in Various Products]. (Compilation; unpublished study received
on unknown date under PP0035; CDL:090033-A)
00113273 E.I. du Pont de Nemours & Co., Inc. (1970) Methoxychlor—Milk:
[Toxicity]. (Compilation; unpublished study received Jul 17,
1970 under 9F0768; CDL:091324-A)
116
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methoxychlor Standard
MRID Citation
00127393 Eaton, H. (1965) Use of Moormans Insecticide Concentrate as a
Spray for Beef Cattle: Experiment #1409. Final rept. (Unpub-
lished study received 1965 under 1157-15; submitted by Moorman
Mfg. Co., Quincy, IL; CDL:122221-A)
00135287 Interregional Research Project No. 4 (1978) The Results of Tests
on the Amount of Methoxychlor Residues in Alfalfa, Beans, Corn,
Peas, Potatoes, Small Grains (Barley, Oats, Wheat), and Sugar
Beets Irrigated with Treated Canal Water, Including a Descrip-
tion of the Analytical Method Used. (Compilation; unpublished
study received Jan 17, 1979 under 9E2165; CDL:097757-A)
00132952 Simmon, V. (1979) In vitro Microbiological Mutagenicity and Un-
scheduled DNA Synthesis Studies of Eighteen Pesticides: Contract
No. 68-01-2458. (Unpublished study received Dec 5, 1983 under
239-2471; prepared by SRI International, submitted by Chevron
Chemical Co., Richmond, CA; CDL:251894-F)
00133008 Simmon, V. (1979) In vitro microbiological mutagenicity and un-
scheduled DNA synthesis studies of eighteen pesticides. By- SRI
International. Research Triangle Park, N.C.: U.S. Environmen-
tal Protection Agency, Office of Research and Development,
Health Effects Laboratory, Genetic Toxicology Div. (EPA 600/1-
79-041; Contract No. 68-01-2458; also in unpublished submission
received Dec 2, 1983 under 279-2038; submitted by FMC Corp.,
Philadelphia, PA; CDL.-251984-C)
00160000 Hudson, R.H. (1984) Handbook of Toxicity of Pesticides to Wildlife.
USDI, Fish and Wildlife Service; Resource Publication 153.
00164734 Cluett, M.; Lowen, W.; Pease, H.; et al. (1960) Determination of
methoxychlor and/or metabolites in milk following topical appli-
cation to dairy cows. Agricultural and Food Chemistry 8(4):277-
281.
00164739 Claborn, H.; Beckman, H. (1952) Determination of 1,1,1-trichloro-
2,2-bis(p-methoxyphenyl)ethane in milk andPMBW?h{aterials.
Analytical Chemistry 24(1):220-222.
0022913 Hill, E.F. ; Heath, R.G.; Spann, J.W. et.al. (1975) Lethal Dietary
Toxicities of Environmental Pollutants to Birds: Special Scientific
Report. Wildlife No. 191. USDI, Fish and Wildlife Service, Pawtuxar
Wildlife Research Center (Unpublished Report)
117
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methoxychlor Standard
MRID Citation
05005125 Burnett, E.M. (1970) Pesticide residues in fat of cattle treated
with backrubbers impregnated with coumaphos, methoxychlor or
DDT. Pesticide Science l(2):70-72.
40098001 Mayer, F.L. and Ellersieck, M. (1986) Manual of Acute Toxicity;
Interpretation and Data Base for 410 Chemicals and 66 Species of
Freshwater Animals; USDI, Resource Publication 160. US Fish and
Wildlife Service, Washington, D.C.
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.
118
-------
IV. FORMS APPENDICES
119
-------
EPA Form 8580-1
OMB Approval No. 2070-0057
Expires 11/30/89
FIFHA SECTION 3ICK2H6I SUMMARY SHEET
E'A REGISTRATION
PRODUCT MAMC
APPLICANT'S NAME
DATE GUIDANCE DOCUMENT ISSUED
With motet to tti* nquirimrnt to wbmit "|»n»ric" dfti itnpo«d by ttM FlFAA action 3(C)(2HBI notict conuincd in tht rtfcrtnctd
Guidtnct Document. I «m wponding m ttit following nwnncr:
O 1. I will mibntit dlti in I timtly minncr to «tirf» ttit following rtquirmmtL If ttit ttn procidurn I wiH u« dt
-------
EPA Form 8580-6
OMB Approval NO. 2070-0057
Expires 11/30/89
(To OtMlity. etrtifvALI^ four ittmtl
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1.1 am duly authorized to rtprcMnt the following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(cK2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE OOCUMCNT DATE
ACTlVf INCMCOICNT
NAMC Of flMM
EPA COMPANY NUMBER
(This firm or group of firms it referred to below as "my firm ".I
2. My firm is willing to develop and submit the data at required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrant* to develop jointly, or to share in the cost of developing, the following required
items or data:
3. My firm has offered in writing to enttr into Mich tn tenement. Copies of ttM off*n tn sttachtd. That offer was irrevocable and included tn offtr to b«
bound by an arbrtnrtion decision under f IFRA Section 3(c)(2)(B)(iii) M final tommim on all arms could not b» rMched otherwm. Tha offtr mm m*4«
to ttit following firm(t) on tht following dated):
NAMC Of PIMM
DATE OF OFFER
However, none of thcte firm(s| accepted my offer.
4. My firm requects that EPA not suspend the regiftration(t) of my firm's product(s). if any of the firms named in paragraph (31 above
have agreed to submit the data lifted in paragraph (2) above in accordance with the Notioi. I understand EPA will promptly inform
ma whether my firm must submit data to avoid suspension of its regmrition(s) under FIFRA Section 3(cH2)(B). (This statement
does not apply to applicants for new producta.1 I five EPA permission to disclose this statement upon request.
TVPIPNAMC
SIONATUME
OATt
-------
US Environmental Protection Agency Registration Standard for:
Washington, DC 20460
V>EPA Product Specific
Data Report
Registration
Guideline No.
Sec. 158.120
Product
Chemistry
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
Sec. 158.135
Toxicology
81-1
81-2
81-3
81-4
81-5
814
Name of Test
Identity of Ingredients
Statement of composition
Discussion of formation of ingredients
Preliminary analysis
Certification of limits
Analytical methods for enforcement limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-density, or specific gravity
Solubility
Vapor pressure
Dissociation constant
Octanol/water partition coefficient
PH
Stability
Oxidizing/reducing reaction
Rammability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion Characteristics
Dielectric breakdown voltage
Acute oral toxieity. rat
Acute dermal toxieity, rabbit ~ '
Acute inhalation toxieity, rat
Primary eye irritation, rabbit
Primary dermal irritation
Dermal sensitization
Testing not
required for my
product listed
above
(Check below)
EPA Registration Number
I am complying with
Data Requirements by -
Citing MR ID No.
_
Submitting Data
(Attached)
(Check below)
~*.
V
- -•
Form Approved
OMB #2070-0057
Expires 11-30-89
(For EPA Use
Only)
Accession
numbers
assigned
Certification
I certify that the statements I have made on this form and all attachments thereto are
true, accurate, and complete. I acknowledge that any knowingly false or misleading
statement may be punishable by fine or imprisonment or both under applicable law.
Typed Name and Title
Signature
Date
EPA Form 8580-4 (Rev. 5-88) Previous edition is obsolete.
-------
CMB Approval No. 2070-005
Expiration Date 11/30/89
GENERIC DMA EXEMPTION STATEMENT
EFA 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 EFA 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 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 .
My firm will apply for an amendment to the registration prior to changing the source
of the active ingredient in our product.
(4) 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).
(5) 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)
EPA Form 8570-27
125
------- |