r/EPA
AgMicy
Pwtektai and Toxic SutMttnow
WMMngtonOC 20460
Guidance for the
Reregistration of
Pesticide Products
Containing
MECOPROP (MCPP)
as the Active Ingredient
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GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
MECOPROP (MCPP)
AS THE ACTIVE INGREDIENT
CASE NUMBER: 0377
CAS 7085-19-0
CAS 1929-86-8
CAS 1432-14-0
CAS 32351-70-5
CAS 28473-03-2
DECEMBER 1988
t *
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OP CONTENTS
I. Introduction
II. Chemical(s) Covered by this Standard
A. Description of Chemical
B. Use Profile
III. Agency Assessment
A. Health Effects
B. Human Exposure
C. Environmental Fate Profile
0. Ecological Effects
E. Other Science Findings
IV. Regulatory Position and Rationale.
A. Regulatory Positions
B. Criteria for Registration
C. Acceptable Ranges and Limits
0. Required Labeling
V. Products Subject to this Standard
VI. Requirement for Submittal of Generic Data
A. What are generic data? . . . . . . .
B. .Who must submit generic data? .........
C. What generic data must be submitted? ,
D. How to comply with DCI requirements
E. Registrant Requests Regarding Data
Requirements and Agency Responses
F. Test Protocols and Standards . .
G. Procedures for requesting a change in protocol
H. Procedures for requesting extensions of time
I. Data Format and Reporting Requirements. . . . ,
J. Existing stocks provisions upon suspension or
cancellation ,
VII. Requirement for Submittal of Product-Specific Data
VIII. Requirement for Submittal of Revised Labeling . . .
IX. Instructions for Submittal
A. Manufacturing use products (sole active)
B. Manufacturing use products (multiple active)
C. End use products (sole active)
D. End use products (multiple active)
E. Intrastate products
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TABLE OF CONTENTS
I. Introduction
II. Chemical(s) Covered by this Standard
A. Description of Chemical
B. Regulatory History
C. Use Profile
III. Agency Assessment
A. Health Effects
B. Human Exposure
C. Environmental Fate Profile
D. Ecological Effects
E. Other Science Findings
IV. Regulatory Position and Rationale.
A. Regulatory Positions
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard
VI. Requirement for Submittal of Generic Data . ,. . . . .
'A. What are generic data? ,
B. Who must submit generic data? .........
C. What generic data must be submitted? ,
D. How to comply with DCI requirements ,
E^ Registrant Requests Regarding Data
Requirements and Agency Responses
F. Test Protocols and Standards
G. Procedures for requesting a change in protocol
H. Procedures for requesting extensions of time
I. Data Format and Reporting Requirements. . . . .
J. Existing stocks provisions upon suspension or
cancellation ,
VII. Requirement for Submittal of Product-Specific Data
VIII. Requirement for Submittal of Revised Labeling . . .
IX. Instructions for Submittal
A. Manufacturing use products (sole active)
B. Manufacturing use products (multiple active)
C. End use products (sole active)
D. End use products (multiple active)
E. Intrastate products
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APPENDICES
I. DATA APPENDICES
Guide to Tables
Table A
Table B
II. LABELING APPENDICES
Summary of label requirements and table
40 CFR 156.10 Labeling Requirements
Physical/Chemical Hazards Labeling Statements
Storage Instructions
Pesticide Disposal Instructions
Container Disposal Instructions
III. BIBLIOGRAPHY APPENDICES . • . •
Guide to Bibliography
Bibliography
IV. FORMS APPENDICES
EPA Form 8580-1 FIFRA §3(c)(2)(B) Summary Sheet
EPA Form 8580-3 Generic Data Exemption Statement
EPA^Form 8580-4 Product Specific Data Report
EPA Form 8580-6 Certification of Attempt to Enter Into an
Agreement with Other Registrants for
Development of Data
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GLOSSARY OF TERMS AND ABBREVIATIONS
a.i. active ingredient
CAS Chemical Abstracts Service
CSF Confidential Statement of Formula
EEC Estimated Environmental Concentration. The estimated
pesticide concentration in an environment, such as a
terrestrial ecosystem.
EP End Use Product
EPA U.S. Environmental Protection Agency
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
LC5o Median lethal concentration - a statistically derived
concentration of a substance that can be expected to
cause death in 50% of test animals. It is usually
expressed as the weight of substance per weight or
volume of water or feed, e.g., mg/1 or ppm.
LD5Q Median .lethal dose - a statistically derived single dose
than can be expected to cause death in 50% of the test
animals, when administered by the route indicated
(oral, dermal, inhalation). It is expressed as a
weight of substance per unit weight of animal, e.g.,
mg/kg.
LEL Lowest Effect Level
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of
recording and tracking studies submitted to the Agency.
MP Manufacturing Use Product
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
OPP Office of Pesticide Programs
OES Office of Endangered Species, U.S. Fish and Wildlife
Service
ppm
Parts per million
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I. INTRODUCTION
EPA has established the Registration Standards program
in order to provide an orderly mechanism by which pesticide
products containing the same active ingredient can be
reviewed and standards set for compliance with FIFRA. The
standards are applicable to reregistration and future
applications for registration of products containing the same
active ingredient. Each registrant of a product containing an
active ingredient subject to this Standard who wishes to
continue to sell or distribute that product must bring his
product and labeling into compliance with FIFRA, as
instructed by this Standard.
The Registration Standards program involves a thorough
review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable
adverse effects" criteria of FIFRA. In its review EPA
identifies:
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the
pesticide.
« - *
2. Additional studies necessary to support continued
registration. The additional studies may not have been
required when the product was initially registered or may be
needed to replace studies that are now considered inadequate.
3. Labeling revisions needed to ensure that the product
is not misbranded and that the labeling is adequate to
protect man and the environment.
The detailed scientific review, which is not contained
in this document, but is available upon request,1 focuses on
the pesticide active ingredient. The scientific review
primarily discusses the Agency's evaluation of and
conclusions from available data in its files pertaining to
the pesticide active ingredient.- However, during the review
of these data the Agency is also looking for potential
hazards that may be associated with the end use products that
contain the active ingredient. The Agency will apply the
provisions of this Registration standard to end use products
if necessary to protect man and the environment.
The scientific reviews and Compendium of Acceptable „
Tses may be obtained from the OPP Public Docket. Write to
OPP Public Docket, Field Operations Division (H7506C),
Office of Pesticide Programs, EPA, Washington, D.C. 20460
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EPA's reassessment results in the development of a
regulatory position, contained in this Registration Standard, on
the pesticide and each of its registered uses. See
Section IV - Regulatory Position and Rationale. Based on its
regulatory position, the Agency may prescribe a variety of steps
to be taken by registrants to maintain their registrations in
compliance with FIFRA. These steps may include:
1. Submittal of data in support of product registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in the
issuance of a Notice of Intent to Cancel or a Notice of Intent
to Suspend (in the case of failure to submit data).
In addition, in cases in which hazards to.man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154 to
examine in depth the risks and benefits of use of the
pesticide. If the Agency determines that the risks of the
pesticide's use outweigh the benefits of use, the Agency
may propose additional regulatory actions, such as cancellation
of uses of the pesticide which have been determined to cause
unreasonable adverse effects on the environment.
EPA has authority under the Data Call-In (DCI) provisions
of FIFRA sec. 3(c)(2)(B) to require that registrants submit data
to answer our questions regarding the chemical, toxicological,
and environmental characteristics and fate of a pesticide. This
Registration Standard lists the data EPA believes are necessary
to resolve our concerns about this pesticide.
These data are listed in the Tables A, B, and C in Appendix I.
Failure to comply with the DCI requirements enumerated in
this Registration Standard may result in issuance by EPA of a
Notice of Intent to Suspend the affected product registrations.
Registrants are reminded that FIFRA sec. 6(a)(2) requires
them to submit factual information concerning possible unreason-
able adverse effects of a pesticide at any time that they
become aware of such information. Registrants must notify
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the Agency of any information, including interim or preliminary
results of studies, if that information suggests possible
adverse effects on man or the environment. This requirement is
independent of the specific time requirements imposed by EPA for
submittal of completed studies called in by the Agency and
continues as long as the products are registered under FIFRA.
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II.
A. Description of Chemicals
The following chemicals are covered by this Registration
Standard:
1.
Common name:
Chemical name:
Empirical Formula:
Structural Formula;
Molecular Weight:
Color:
Physical State:
Melting Point:
CAS Number:
Shaughnessy No.:
Trade names:
Other names:
2.
Common name:
Chemical name:
Empirical Formula:
Structural Formula;
Molecular Weight:
Color:
Physical State:
Melting Point:
CAS Number:
MECOPROP; MCPP (preferred name)
2-(2-methyl-4-chlorophenoxy)
propionic acid
a—CM—COOH
214.7
Colorless to White
Crystalline solid
94«-95«C
7085-19-0 (racemate)
93-65-2 (unspecified sterioisomer)
031501
MCPP; CMPP; Methoxone; Duplosan
KV; RD4593
(RS)-2-(4-chloro-o-tolyloxy)-
propionic acid; (±)-2-(4-chloro-2-
methylphenoxy) propionic acid;
(±) -2-(4-chloro-2-methylphenoxy)
propanoic acid;(±)-2-[(4-chloro-o-
toly1)oxy]propionic acid;
2-(4-chloro-o-tolyloxy)propionic
acid; 2-methyl-4-chlorophenoxy)-
propionic acid; 2-(4-chloro-2-
methylphenoxy)propionic acid;
2-(4-chloro-o-tolyloxy)propionic
acid.
MCPP Potassium Salt
2-(2-methyl-4-chlorophenoxy)- -
propionic acid, potassium salt.
C10H10C1KO3
252.7
Data Gap
Data Gap
Data Gap
1929-86-8 —
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Shaughnessy No:
Trade names:
Common name:
Chemical name:
Empirical Formula:
Structural Formula:
Molecular Weight:
Color:
Physical State:
Melting Point:
CAS Number;
Shaughnessy No.:
Common name:
Chemical name:
Empirical Formula:
Structural Formula:
Molecular.Weight:
Color:
Physical State:
Melting Point:
CAS Number:
Shaughnessy No.:
Common name:
Chemical name:
Empirical Formula:
Structural Formula:
Molecular Weight:
Color:
Physical State:
Melting Point:
CAS Number:
Shaughnessy No.:
Trade names :-
031503
Gordon's Mecomec; Hedonal; MCPP;
Methoxone M; MCPP-K-4; and Mocopex
MCPP Diethanolamine Salt
2-(2-methyl-4-chlorophenoxy)-
propionic acid,diethanolamine salt
C14H22C1N05
CH,
1
0—CH—COO- *NH,(CH,CHtOH)
319.9
Data Gap
Data Gap
Data Gap
1432-14-0
031516
MCPP Dimethylamine Salt
2-(2-methyl-4-chlorophenoxy)
propionic acid, dimethylamine salt
C12H18C1N03
CH,
0—CH—COO- *NH,fCH,1
259.3
Da.ta Gap
Data Gap
Data Gap
32351-70-5
031519
MCPP Isooctyl Ester
2-(2-methyl-4-chlorophenoxy)
propionic acid, isooctyl ester
C18H27C103
CH,
O—CH—
326.9
.Data Gap
Data Gap
Data Gap
28473-03-2 - .
031563
MCPP, isooctyl ester; Clifton CMPP
60 (butyl and isooctyl esters); and
U 46 KV-Ester
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B. Regulatory History
The herbicidal properties of MCPP were first reported in the
Proceedings of the 3rd British Weed Control Conference in 1956.
The first USA federal registration of MCPP was approved in May
of 1964. Information on dates of initial registrations are
listed below.
Form of MCPP
Potassium Salt
Diethanolamine Salt
Dimethylamine Salt
Isooctyl Ester
Acid
Date
Initially
Registered
May 1964
Feb 1965
Sep 1966
Aug 1971
Apr 1972
Producers of
Technical
Pesticide
Products:
Species Controlled:
«
Registrations:
(Active Ingredients in
Present Registrations)
Special Local Needs
Registrations:
Aceto Chemical Co., Inc.
Akzo Zout Chemie Nederland
Dow Chemical USA
Gilmore, Inc.
A. H. Marks & Co., Ltd
Rhone-Poulenc Ag Co.
More than 70 broadleaf weeds
Single Active Ingredient
Multiple Active Ingredient
Total
MCPP Dimethylamine salt
MCPP Diethanolamine salt
44
290
334
6
1
In 1987, the Agency issued a Data Call-In for manufacturing
process information to determine if MCPP pesticides become
contaminated with chlorinated dibenzo-p-dioxins or dibenzofurans
during manufacture. The Agency is concerned that chemicals which
contain a halogenated cyclic moiety, such as MCPP, have the
potentiat-of becoming contaminated with chlorinated dibenzo-p-
dioxins or dibenzofurans under certain conditions of manufacture.
Submissions responding to this data call-in were received in
early 1988, too late for inclusion in this standard.
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C. Use Profile
MCPP products are selective, systemic, post-emergent,
broadleaf herbicides that are used primarily on lawns and turf
found on golf courses, parks, around homes and institutions, and
along roads and fences. They are also used on commercial sod.
The approximate percentages of MCPP pesticides used on an annual
basis by major use sites are 40 to 64% on golf courses, 32 to 53%
on home lawns, 4% on commercial sod, and 1 to 4% for other
outdoor applications. Between 1 to 6 million pounds of active
ingredients are used annually. Abut 10% of commercial sod is
treated with one or more of the MCPP pesticide products; and,
this treatment is usually in combination with other herbicides
and fertilizers. MCPP is most often combined with the herbicides
2,4-D, dicamba, MSMA, MCPA, and/or DCPA in premixes or tank mixed
form. Other MCPP use information is summarized below.
Pests Controlled:
Registered Uses:
Principle Uses:
Method of
Application:
Used especially for control of
prostrate chickweed, stitchwort,
ground ivy, knowtweed, clover
and plantain.
Terrestrial nonfood
Golf courses, lawns, ornamental
and sports turf, and general
indoor/outdoor treatments.
Aquatic nonfood ''
Drainage ditch banks.
Forest trees
Site preparation.
Ninety-six percent of the
production is used on turf,
including lawns, sport turf and
commercial sod production.
A small percentage (1-4%) is used
in noncrop areas such as rights-of-
way, drainage ditch banks and
forest site preparation.
Foliar applications by ground
equipment including spreader,
sprayer, and pressurized hose-
end sprayer. Application by air on
specific noncropland sites.
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Rates of
Application:
Formulations:
Mode of Activity:
Terrestrial Nonfood Crop
0.05-0.19 Ibs ai/5000 sq ft.
0.02-0.6 Ibs acid equivalents
(ae)/5000 ft.
0.7-0-4.0 Ibs ae/A.
Aquatic Nonfood Crop
1.07-0.15 Ibs ae/5000 ft.
Forest Trees
2.0-4.0 Ibs ae/A.
Granular, 0.035%-0.84%; wettable
powder, 2.5%-15.1%; emulsifiable
concentrate, 0.145%-51.9%; soluble
concentrate/ liquid, 0.91%-51.9%;
ready to use, 0.1%-3.28%;
pressurized liquid, 0.108%-0.308%.
Disrupts normal cell division by
stimulation of mitotic of
activity.
8
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III. AGENCY ASSESSMENT
The Agency has reviewed all data in Agency files as of
November 21, 1987, supporting the registration of MCPP
pesticides. The Agency's scientific findings and conclusions
are discussed in this section.
A. Health Effects
Toxicity studies have been submitted on MCPP acid but not
on the salts or the isooctyl ester. The studies on MCPP acid are
discussed below. The toxicity data set for MCPP acid is complete
except for a dermal sensitization study, a 21-day dermal
toxicity study and a Chinese Hamster bone marrow cytogenetics
study, which are required. Chronic toxicity, oncogenicity,
reproduction and general metabolism studies are not required
because MCPP and its salts and ester do not have food uses.
The potassium salt is regarded as equivalent to MCPP acid,
so a separate toxicity data set is not required. The
diethanolamine salt, dimethylamine salt and the isooctyl ester
are more complex moieties and may display different toxicological
properties. Therefore a full set of acute studies, including
inhalation, subchronic (21-day) dermal toxicity, teratogenicity
and mutagenicity studies are required for each of these
materials.
1. Acute Toxicity
Technical MCPP acid can be lethal following acute oral
exposure, but the toxicity is low. Acute oral exposure of rats
to 500 mg/kg or greater caused labored breathing, prostration,
and death (1*050 - 558 mg/kg of technical MCPP—Toxicity Category
III).
The dermal toxicity is low. Application of 2 g/kg to skin
of rabbits caused no deaths, placing MCPP acid in Toxicity
Category IV via this route.
Available data are inadequate to characterize the acute
inhalation toxicity of MCPP.
2. Primary Eye Irritation
Sufficient data are available to indicate that technical
MCPP acid produces persistent corneal opacities, iritis, and
conjunctival irritation in both washed and unwashed eyes.
MCPP acid causes significant and persistent eye irritation,
which places it in Toxicity Category I.
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3. Primary Dermal Irritation
Sufficient data are available to indicate that technical
MCPP acid causes no dermal irritation in rabbits exposed for 24
hours to O.Sg on both abraded and unabraded skin.
4. Acute Delayed Neurotoxieitv
No data are available on the acute delayed neurotoxicity of
MCPP. Since this test is only required for organophosphate
inhibitors of cholinesterase or analogs or metabolites of such
inhibitors, and MCPP does not fall in one of these categories, a
study is not required.
5. $uj?ch.ronic Oral
An acceptable study in rats is available on the subchronic
oral toxicity of technical MCPP acid. Oral exposure of 15
rats/sex to technical MCPP for 90 days at doses of 3, 9, and 27
mg/kg caused increased creatinine levels in females and decreased
glucose levels in males at 27 mg/kg; increased kidney weights in
both sexes at 27 mg/kg and males at 9mg/kg; and increased
relative kidney weights in both sexes at 9 and 27 mg/kg. The NOEL
was 3 .mg/kg.
6. S\lb.ch.ronic Dermal
Data are not available on the subchronic dermal toxicity of
MCPP.
7. Teratoaenieity
A teratogenicity study in rats with MCPP acid showed no
maternal effects, but, at 125 mg/kg, increased intra-uterine
deaths, decreased crown/rump lengths, and an increased incidence
of delayed or absent ossification of the sternebrae were
reported. Twenty eight female rats/dose were given doses of 20,
50, or 125 mg/kg of MCPP on days 6-15 of gestation. There were
38 control females. The "No Observable Effect Level" (NOEL) was
50 mg/kg.
A teratogenicity study in rabbits showed no fetotoxic or
teratogenic effects, and only slight body weight gain
differences in the mothers exposed to 75 mg/kg. Fifteen
rabbits/dose were given 12, 30, or 75 mg/kg/day of MCPP acid on
days 6-18 of gestation. There were 30 control rabbits. There
were no effects of exposure on fetotoxicity or teratogenicity
measures. The maternal NOEL was 30 mg/kg. The developmental
NOEL was greater than 75 mg/kg.
10
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8. Mutaoenicitv.
a. Gene Mutations. Sufficient data are available to
demonstrate the potential of MCPP acid to cause gene mutations.
In an acceptable study, no increases were seen in either: (1)
Reverse mutation in four Salmonella strains exposed to paper
discs impregnated with 2000 ug MCPP (spot test), in both the
presence and absence of liver microsomes from rats treated with
phenobarbital; or (2) Forward mutation to streptomycin resistance
in S. coelicolor A3(2) exposed to increasing concentrations of
MCPP up to 1000 ug, in both spot and standard plate incorporation
tests, also with and without metabolic activation of rat liver
microsomes with phenobarbitol.
b. Chromosomal flbeiT?tJ91?- Available data are inadequate
to characterize the effects of MCPP on chromosomal aberrations.
A Chinese Hamster bone marrow cytogenetics study is required.
c. Other Tests. Sufficient data are available to
characterize the effects of MCPP acid on sister chromatid
exchange (SCE). MCPP caused an increase in SCE after single oral
doses of 470 and 3800 mg/kg in Chinese Hamsters. MCPP was
positive for increasing SCEs in a dose-dependent fashion above
the control value of 3.06 SCEs/cell, at single oral doses of 470
mg/kg (3.77 SCEs/cell, p < 0.05) and 3800'mg/kg (5.21 SCEs/cell,
p < 0.01), both doses also causing clinical toxicity.
10. Special Studies
As discussed below in Section II. B. 2, Applicator
Exposure f additional data are needed to assess the risk posed by
the teratogenic potential of MCPP. A dermal absorption study is
needed to refine exposure assessments. If the dermal absortion
study shows there is significant absorption of MCPP, a dermal
teratogenicity study will be required.
11
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B. Human Exposure
1 . Poisoning Incidents
There are no reports of poisoning incidents for MCPP.
2. Applicator Exposure
a. Preliminary Risk Assessment
One biological monitoring study reported on results of
urinary MCPP excretion in commercial lawn applicators. The
study measured exposure to applicators applying a mixture of
MCPP, 2,4-D, and Dicamba to lawns with hand-held large droplet
nozzle sprayers. The concentration of MCPP used in that study
was 330 mg/1. There was no MCPP detected in applicators' urine
samples greater than 0.01 ppm, the lowest level detectable with
the analytical method used.
The Agency used surrogate data to evaluate expected exposure
associated with the handling of MCPP. Exposure and risk
estimates were made based on the three typical uses of MCPP for
mixers, loaders, and applicators using open pour and closed
loading for 1) commercial lawn, 2) commercial sod use with
compressed air and hose end sprayers, and for 3) home-owner use.
The results are discussed below and summarized in the table which
follows.
Exposure ^o ?n individual mixing . loading and applying
MCPF on a commercial sod farm was estimated to be 1.0
mg/kg/day. This estimation assumed that the
mixer/loader wore gloves and a long sleeved shirt and
long pants during the open pour loading, and then
applied the MCPP using ground boom equipment (without
wearing gloves). Based on the NOEL of 50 mg/kg/day for
developmental effects, and a dermal absorption of 100%,
the calculated MOS for the commercial sod farmer is
estimated to be 50.
The exposure for the commercial home lawn mixer /loaders
uffifltg an open pour system is estimated to be about 0.43
mg/kg/day, assuming gloves, a long sleeved shirt, and
long pants are worn. This is equivalent to a MOS about
120 for the mixing and loading operation, based on a
NOEL of 50 mg/kg/day, a dermal absorption of 100%, and
surrogate data from the 1987 Dinoseb testimony of Curt
Lunchick. The applicator was assumed to be a different
individual than the mixer/loader.
The MOS for the homeowner was calculated assuming short
sleeved shirts, long pants and shoes were worn during
all handling operations, including application using
12
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compressed air sprayers or hose end sprayers. The
typical application was assumed to involve the use of
0.36 Ib active equivalent HCPP/acre for 3.7 hours a
day. Surrogate data published by J.E. Davis, et al.
were used to roughly estimate the exposure to
homeowners.
Based on the 50 mg/kg/day NOEL and a dermal absorption
of 100%, the exposure to homeowners would be about
0.024 mg/kg/day (MOS«2100) if compressed air sprayers
were used, and be about 0.082 mg/kg/day (MOS-610) if
hose end sprayers were used. (Exposure estimates may
be underestimated because homeowners typically wear
only minimal clothing during pesticide treatment.)
The Davis study was considered too limited for a final
exposure assessment for the reregistration of HCPP.
The Agency believes these estimates overstate the actual
risk. Most liquid formulations have dermal absorption of 50% or
less (usually 5-25%) and not 100%. The Agency finds that the MOS
for commercial sod farmers and workers exposed through other uses
would probably be over 100 when corrected for the actual extent
of dermal absorption.
EXPOSURE EST1
USE
C.Qmj|ercial Lawn Use
Mixer/Loader
Open Pour - long pants,
long sleeves, gloves
Closed Loading - long pants,
long sleeves, gloves
Applicators
Homeowner Use
Compressed Air Sprayer
Hose End Sprayer
Sod Farm Use
Mixer/Loader
Open Pour - long pants,
long sleeves, gloves
Closed Loading - long pants,
long sleeves, gloves
Applicators
Open Pour - no protection
Closed Loading - no protection
IRGINS OF SAFETY fMOSsl
EXPOSURE
ESTIMATE
MOS
ESTIMATE
0.430 mg/kg/d 120
0.007 mg/kg/d 7100
No available data
0.024 mg/kg/d
0.082 mg/kg/d
2100
610
0.780 mg/kg/d 64
0.012 mg/kg/d 4200
0.220 mg/kg/d 230
1.000 mg/kg/d 50
0.230 mg/kg/d 220
13
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b. Exposure DataRequirements
Applicator Exposure Data
Because of the inadequacy of the available exposure data,
the Agency is requiring exposure studies for the following uses:
commercial hone lawns (hose end sprayer, power sprayer, back
pack)y commercial turf (ground boom); and homeowner use (hose end
sprayer and compressed air sprayer). Exposure studies for any
other uses of MCPP should also be included. Protocols for these
studies should be submitted for Agency approval prior to
initiation of the studies.
Reentry Data
MCPP meets both the toxicity and exposure criteria for
requiring reentry data. MCPP has been determined to be a
developmental toxicant and workers may receive post-application
exposure to MCPP through its commercial use on turf. Thus ,the
Agency is requiring foliar dissipation, soil dissipation, and
dermal exposure studies. These data are needed to assess
exposure to MCPP residues resulting from reentry into treated
areas on commercial turf farms to harvest or handle treated
turf. Respiratory exposure data requirements are reserved,
pending submission and Agency evaluation of the complete
toxicology data base for MCPP, including dermal and inhalation
toxicity. '
These data will also be used to assess the risks to persons
exposed to residues on lawns, golf courses and other areas where
MCPP is applied.
C. Environmental Fate Profile
Environmental fate studies partially satisfy the data
requirements for the MCPP acid and its inorganic potassium salt.
Studies were presented on the MCPP acid only. There are no
acceptable studies for the organic salt and ester forms of MCPP.
The available data are insufficient to fully assess the
environmental fate of these MCPP pesticides. Data for
terrestrial nonfood and aquatic nonfood uses must be submitted
for all each MCPP pesticide (see table A).
1. Hydrolysis
Supplemental hydrolysis data indicate that MCPP acid was
stable to hydrolysis: Ring-labeled [14C]MCPP (96.9% pure) at
51-52 ppm did not hydrolyze during 740-751 hours of incubation in
sterile buffered aqueous solutions (pH 5, 7, and 9) at 25 C.
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2. Photodegrration in Water
There was slow photodegradation in water for the sane ring
labeled [14C]MCPP formulation, with a half-life of 739 hours at
the same pHs under continuous irradiation with artificial light.
Two major and several minor degradates were isolated. There was
no degradation of the MCPP acid formulation in the dark control
solutions during 739-748 hours of incubation.
3. Leaching and Adsorption/Desorption of Aged MCPP
Residues
Based on batch equilibrium experiments, ring-labeled
[14C]MCPP acid (>96% purity) at 0.606-12.0 ug/mL, was very
mobile in sand, sandy loam, silt loam, and silty clay loam soils;
Freundlich Kads values ranged from 0.199 to 0.687. The
equilibrations were conducted in 3 g/10 mL soil:solution
for 1 hour. Adsorption was strongly correlated with the organic
matter content of the soils (correlation coefficients ranged
from 0.950-0.999). In general, 25-51% of MCPP was desorbed from
the soils after 1 hour of shaking with MCPP-free solutions.
Based on soil TLC experiments, ring-labeled [14C]MCPP acid
(>96.3% purity) was very mobile in sand, sandy loam, and silt
loam soils (Rf 0.93-1.0), and was mobile in silty clay loam soil
(Rf 0.74).
Based on soil TLC experiments, unaged ring-labeled[14C]MCPP
acid (>96.3% purity) was mobile (Rf 0.86) in sandy loam soil.
However, supplemental information indicated that uncharacterized
aged (30 days) [14C]MCPP residues were immobile in sandy loam
soil (Rf 0.08).
4. Ground Water Assessment
Available data indicate that MCPP acid is mobile in many
mineral soils, and if not first degraded, may potentially leach
to groundwater. However, it is unclear whether it is possible
for there to be sufficient persistence in the root zone to allow
measurable leaching to ground water. No ground water monitoring
studies are required at this time, but if the requested
environmental fate studies indicate that MCPP or its degradates
remain in water and may leach significantly, a monitoring study
may be required.
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5* Pesticide ACTmnM^ation in Fist}
There is low level bioaccumulation of MCPP acid in fish.
[14C] NCPP residues accumulated in bluegill sunfish with
bioconcentration factors of 1.2, 5.5, and 3.OX in edible tissues,
nonedible tissues, (head, gills, viscera, and fins), and whole
fish, respectively, during 28 days of exposure at 1 ppo in a
flow-through system. Maximum levels of [14C] residues were 1.35
ppm in edible tissues, 5.62 ppm in non-edible tissues, and 3.09
ppm in whole fish. In the edible tissues, MCPP residues were
found to be 0.23-0.24 ppm at 21 and 28 days post treatment. The
major degradate in the edible tissues was "mecoprop methyl",
which was isolated at 0.34 ppm and 0.47 ppm at 21 and 28 days,
respectively. At 21 and 28 days posttreatment, two unidentified
degradates were 0.05-0.19 ppm; uncharacterized residues in the
water soluble phase of the extracts were 0.09-15.4 ppm; and
unextractables were 0.24-0.26 ppm. Residues accumulated at 28
days were depurated quickly; at day 14 of depuration, [14C]
residues were 0.03 ppm in edible tissues, 0.64 ppm in nonedible
tissues, and 0.29 ppm in whole fish. The Agency finds that the
observed levels of bioaccumullation are of virtually no
significance.
D. Ecological Effects
1. End Use Products
The only studies received which tested MCPP end use
products were those in which the test substance a mixture of one
or more forms of MCPP and other active ingredients. Because data
on mixtures are not acceptable, these studies were not reviewed.
End use product testing is incomplete as discussed below and data
are required.
2. Technical Products
a. Avian Studies
Avian toxicity data are complete for MCPP acid, partially
complete for MCPP dimethylamine salt, and nonexistent for all
other MCPP pesticides. However, the Agency will accept data on
MCPP acid to support uses of the potassium salt of MCPP. (See
data requirements in the Data Table A in Appendix I.)
1) Avian sincrle-doae oral studies on MCPP acid indicate
an acute oral LD50 value of 700 mg/kg for the bobwhite
quail. MCPP acid may therefore be considered slightly
toxic to avian species on an acute basis. Based on
available toxicity information, no .precautionary
labeling for MCPP acid nor MCPP potassium salt is
indicated. No acute oral studies were submitted for
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the salts or ester MCPP products; therefore, no acute
toxicity determinations can be made at this time for
the diethanolamine salt, dimethyl salt, and the
isooctyl ester forms of MCPP.
2) Avian dietary studies on MCPP acid indicate
values of >5620 ppm for the mallard and 5000 ppm for
the bobwhite. MCPP acid may therefore be considered
practically non-toxic to avian species on a subacute
basis. Dietary studies for MCPP dimethylamine salt
indicate LCsg values greater than 12000 ppm for the
mallard and 14000 ppm for the Japanese quail.
However, the Japanese quail is not considered
representative of an upland game bird in the United
States. The bobwhite quail is the preferred species.
Thus, the Japanese quail study does not fulfill EPA
requirements .
Additional avian dietary data are required on the MCPP
dimethylamine salt; and, all data are required for the
diethanolamine salt and the isooctyl ester. Although
Guidelines requirements are only partially fulfilled,
the above data indicate that MCPP dimethylamine salt
has very low toxicity to avian species on a subacute
dietary basis. No determination of dietary toxicity to
avian species can be made for the diethanolamine salt
or the isooctyl ester because of a lack of acceptable
studies. .
3) Avian Reproduction Testing. No avian reproduction
studies were submitted. There is insufficient toxicity
and environmental fate data available at this time to
determine if this test is required for any of the forms
of MCPP.
b. Aquatic Studies
1) Acute Freshwater Fish Toxicity Testing.
Available freshwater fish toxicity studies indicate
that MCPP acid (technical formulation) has very low
acute toxicity to freshwater fish (rainbow trout LC50 -
124 ppm) . The submission of rainbow trout (a coldwater
species) studies only partially satisfied the
freshwater fish data requirements for the MCPP acid and
MCPP potassium salt. The data requirement for testing
a warmwater species has not been fulfilled.
A determination of acute toxicity for technical or end-
use products to freshwater fish cannot be made for the
dimethylamine salt, the diethanolamine salt, or the
isooctyl ester because of a lack of toxicity data.
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2) Acute Freshwater Aquatic Invertebrate Testing.
There were no acceptable acute freshwater aquatic
invertebrate data received. Therefore, the requirement
for acute toxicity testing for technical and end use
products containing MCPP on freshwater aquatic
invertebrates has not been fulfilled.
3) Effects on Eatuarine and Marine Organisms. Given
that MCPP formulations are used in drainage ditch-banks
and that MCPP is a major herbicide used on turf (with
golf courses in the mid-Atlantic region accounting for
most of this use), significant runoff to estuarine/
marine environments may be expected. There were no
studies on estuarine and marine organisms submitted for
review. Therefore, the requirement for acute toxicity
testing for the acid and all salt and ester forms of
MCPP on estuarine and marine organisms has not been
fulfilled. Testing is required for some formulations
and reserved for others, pending the results of acute
aquatic freshwater fish and acute aquatic freshwater
invertebrate studies and environmental fate data.
4) Fish Early Life-Stage and Aquatic Invertebrate
Life-Cvcle Testing. There were no fish early life-
stage nor aquatic invertebrate life-cycle test results
submitted using either technical or typical end use
MCPP products. There is insufficient acute toxicity
data and environmental fate data available at this time
to determine if these tests are required. Thus,
requirements for testing technical and end use acid,
salt, and ester formulations of MCPP are reserved for
fish early life-stage and aquatic invertebrate
organisms.
c. Nontarqret Plants
There are no acceptable data for toxicity of any MCPP
formulation to nontarget plants. Therefore, no assessment of
toxicity can be made at this time.
Air- MCPP formulations are labeled to control a variety of
broadleaf weeds. Therefore, Tier I testing will not be required
because, by definition, herbicides are hazardous to plants. In
order to assess the potential hazard to nontarget plants, the
Tier II nontarget plant studies as specified in the data table
in Appendix I are required for all forms of MCPP. Further, for
those MCPP formulations for which drainage ditchbank application
is identified (dimethylamine salt, potassium salt, isooctyl
ester), Tier II aquatic plant testing must utilize all of the
following species: 1) duck-weed fLemna gibbal, 2) marine diatoms
fSkeletonema costaturn). 3) blue-green alga (Anabaena flos-aquael.
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4) freshwater green alga (Selenastrum capricornutum), and 5) a
freshwater diatom. For those MCPP formulations not identified as
having drainage ditchbank application (MCPP acid and
diethanolamine salt), testing may be completed using Selenastrum
capricornutum.
d. Endana e r ed Spec i e s
There are no data to indicate whether MCPP acid or any MCPP
salt or ester formulation may affect endangered plant or animal
species. Therefore, the Agency cannot assess the potential of
MCPP or its salts or ester to adversely affect endangered
species.
e. Nontarget Insects
There are no data to indicate whether products containing
MCPP acid or its salts and ester affect honeybees and nontarget
insects. No determination can be made that MCPP acid or any salt
or ester form of MCPP will adversely affect nontarget insects.
No data are required at this time.
E. Other Science Findings
MCPP acid and its salts and ester contain a chlorinated
phenoxy group within their structure. The Agency has found that
chemicals having such components in their structure may have been
produced under conditions which can lead to-the formation of
chlorinated dibenzo-p-dioxins or dibenzofurans as manufacturing
impurities. Accordingly, the Agency has required the submission
of manufacturing process information to address this possibility.
The Agency will evaluate these data to assess the likelihood of
dioxin/furan formation during manufacture. If the manufacturing
process data show that chlorinated dibenzo-p-dioxins or
dibenzofurans are likely to occur, the Agency may require
analytical data to characterize or quantify these contaminants.
The Agency's concern about chlorinated dibenzo-p-dioxins and
dibenzofurans is based on the extreme toxicity of 2,3,7,8-
tetrachloro-dibenzo-p-dioxin, which causes lethal effects in
aquatic species, birds and some mammals. These impurities are
also known to be carcinogenic, teratogenic, fetotoxic, and
acnegenic.
The Agency is also concerned that the amine salts of MCPP
may become contaminated by nitrosamines under certain conditions
of manufacture and storage. Information on the manufacture and
storage of products containing MCPP amine salts is required to
assess possible contamination. The Agency's concern is based on
the well-established carcinogenicity of nitrosamines.
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IV. REGULATORY POSITION AND
A. REGULATORY POSITIONS AND
The Agency has made the following determinations based on
review and evaluation of all available acceptable data on MCPP
pesticides .
1. Special Review
The Agency is deferring a decision on initiating a Special
Review of MCPP pesticides until data needed to refine worker
exposure estimates have been submitted and evaluated.
Rationale; A teratogenicty study in rats showed a NOEL of 50
mg/kg for developmental effects of MCPP acid. The Agency
estimated exposures to workers and users of MCPP pesticide
products and found that margins of safety were below 100 for
mixer/ loaders and applicators handling MCPP in commercial sod
farms. These estimates are based upon the assumption that the
rate of dermal absorption is 100 percent. The Agency is
requiring dermal absorption and applicator exposure data so that
these risk estimates can be refined. When these data are
available, the Agency will evaluate them to determine whether
further regulatory action is warranted.
Based on dermal absorption data' obtained on other
pesticides, the Agency believes that the rate of dermal
absorption is likely to be below 50 percent. Therefore, the
Agency believes that risks to workers are likely to be acceptable
for dermal absorption. Accordingly, other than requiring the use
of protective clothing (which would be required in any case) , the
Agency is not imposing any interim risk reduction measures.
2. Restricted Use
The Agency will not restrict the use of MCPP products at
this time.
Rationale; The Agency does not have sufficient information to
determine that classification of MCPP pesticides as restricted
use pesticides is warranted. The Agency is requiring data needed
to refine worker exposure estimates. When these data become
available, the Agency will assess the risks posed by use of MCPP
pesticides and will reexamine its position on classification.
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3. Exposure Data Requirements
The Agency is requiring a dermal penetration study and
exposure estimates for applicators involved in commercial lawn
uses. A dermal teratology study may also be required if the
dermal absorption of MCPP is significant. These data are needed
to assess the teratogenic risk posed by MCPP pesticides to
persons handling MCPP pesticides for lawns, turf, and sod
applications.
Rationale; A preliminary risk assessment of the developmental
effects of MCPP, based upon limited exposure data and the
assumption of 100% dermal absorption, showed inadequate margins
of safety for some categories of workers. The required studies
will provide data needed to refine the exposure estimates for
these workers and more accurately assess the margins of safety.
4. Basic Data Requirements
The Agency will require data specific to the amines and the
ester formulations as well as the acid, as reflected in the data
tables.
Rationale: When MCPP is formulated as an ester or amine, the
physical characteristics, biological activity and fate in the
environment may be affected. The Agency has little or no data to
evaluate the effects of the ester or amine derivatives of. MCPP.
Data on each amine and ester derivative are needed.to evaluate
the hazards associated with each registered form of MCPP.
5. Ground Water Concerns
The Agency will evaluate the potential of MCPP pesticides to
contaminate ground water after receiving and evaluating
additional required environmental fate studies. Until these
studies are submitted and evaluated, the statement given in
section IV. D is required.
Rationale; MCPP pesticides have been identified as chemicals
with the potential to contaminate ground water because they are
mobile in mineral soils. It is unknown whether MCPP will
persist^sufficiently in the soil surface to prevent measurable
leaching into ground water.
6. Reentry Data Requirement
The Agency will require reentry data for MCPP pesticides.
Workers are not to reenter treated areas until the spray has
dried or the dust has settled. (See label statements given in
Section IV. D.)
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Reentry data requirements are triggered by the
finding that MCPP is teratogenic in the rat and that its uses,
such as the commercial sod farm use, require workers to reenter
MCPP-treated areas. It is therefore necessary to obtain data
needed to estimate the extent of worker exposure to MCPP
residues. In order to minimize exposure to MCPP residues , workers
should not reenter treated areas unitl the spray has dried or the
dust has settled.
7. Protective Clothing Requirement
The Agency is requiring that protective clothing be used.
Mixer/loaders and applicators must wear long pants, long sleeved
shirts, and gloves. Persons applying liquid MCPP products such
as sprays, are required to use goggles to cover their eyes. (See
label statements given in Section IV. D.)
Rationale; These measures are needed to reduce dermal and ocular
exposure to MCPP. Eye exposure should be reduced because MCPP is
extremely irritating to the eye (it has been placed in toxicity
category I for primary eye irritation) . Exposure via the dermal
route, which is the major route of exposure, should be reduced
because of the teratogenic potential of MCPP.
8. Endangered Species
Until all required toxicity .studies are received and
evaluated, there can be no determination that MCPP acid or any
MCPP pesticide' would affect endangered animal or plant species.
Therefore, no endangered species labeling statement is required
at this time.
Rationale; The Agency lacks data to show whether the use of MCPP
pesticides affect any endangered plant or animal species.
Phytotoxicity data on nontarget plants are required. If data
indicate that endangered species may be adversely affected by
registered uses of MCPP, the Agency will initiate consultation to
determine what measures are necessary to preclude jeopardy to
those species.
9. Dio^ins /Dibenzofurans
The Agency is requiring the submission of manufacturing and
product chemistry data to address the potential contamination of
MCPP and its salts, amines and esters with chlorinated dibenzo-p-
dioxins and dibenzofurans.
Rationale; Chemicals with chlorinated cyclic components may
become contaminated with chlorinated dibenzo-p-dioxins and
dibenzofurans under certain conditions of manufacture.
Information on the manufacture of MCPP acid and its salts and
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esters is required to assess whether contamination with such
impurities is likely to occur. The Agency's concern is based
upon the toxicity of 2,3,7,8-tetrachlorodibenzo-p-dioxin and the
potential toxicity of related compounds.
10. Nitrosamines
The Agency is requiring the submission of analytical and
product chemistry data to address the possible contamination of
MCPP amines with nitrosamines.
Rationale! Nitrosamines might be produced in MCPP amine salts
under certain conditions of manufacture and storage. Information
on the manufacture and storage of MCPP amine salts is required to
assess possible contamination. The Agency's concern is based on
the well-established carcinogenicity of nitrosamines.
11. Data for Immediate Agency Review
The Agency has identified certain data that will receive
immediate review when submitted.
Rationale: Certain of the data being required are essential to
resolve risk concerns, or may trigger the need for further
studies which should be initiated as soon as possible. The
following studies have been identified to receive priority
review as soon as they are received by the Agency: product
chemistry, environmental fate, dermal absorption, applicator
exposure'and reentry data, toxicity data on MCPP salts and ester,
and Tier II phytotoxicity data.
12. Cqntinuation of Registration.
While data gaps are being filled, currently registered
manufacturing use products (MPs) and end use products (EPs)
containing MCPP may be sold, distributed, formulated and used,
subject to the terms and conditions specified in this Standard.
Registrants must provide or agree to develop additional data,
as specified in the Data Appendices, in order to maintain
existing registrations.
Rationale-: Under FIFRA, the Agency does not normally cancel or
withhold registration simply because data are missing or are
inadequate (see FIFRA section 3(c)(2)(B) and 3(c)(7)).
Issuance of this Standard provides a mechanism for identifying
data needs and labeling changes arising from available data.
Required data will be reviewed and evaluated, after which the
Agency will determine if additional regulatory actions are
necessary.
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B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this standard,
products must contain one or more of the forms of MCPP
(Mecoprop) , bear required labeling, and conform to the product
composition, acute toxicity limits, and use pattern requirements
listed in this document.
C. ACCEPTABLE FAFGES AND LIMITS
1. Product Composition Standard
To be registered or reregistered under this Standard,
manufacturing-use products (MPs) must contain one or more of the
following MCPP products: MCPP acid; MCPP potassium salt; MCPP
diethanolamine salt; MCPP dimethylamine salt; MCPP isooctyl
ester. Each MP formulation proposed for registration must be
fully described with an appropriate certification of limits,
stating maximum and minimum amounts of the active ingredient and
inert ingredients which are present in products, as well as
impurities found at greater than 0.1%.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade
and manufacturing-use products containing any of the above forms
of MCPP pesticides provided that the product labeling bears.
appropriate precautionary statements for the acute toxicity
category in which each product is placed.'
3. Use Patterns
To be registered under this Standard, manufacturing-use
products may be labeled for formulation into end-use products
bearing Federally registered uses. The EPA Compendium of
Acceptable Uses lists all registered uses, as well as approved
maximum application rates and frequencies (for availability, see
page 1) .
The use patterns currently registered are nonfood
terrestrial, aquatic, forestry, and domestic.
0. LABELING
All products must bear appropriate labeling as specified in
40 CFR 156.10, PR Notices 83-2, 83-3 and this Standard, or must
be revised to conform to those specifications. Appendix II
contains information on label requirements.
Time Frames for Compliance. Pesticide products containing
one or more of the forms of MCPP may not be released for shipment
by the registrant after December 1989, unless the products bear
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amended labels which comply with the requirements of this
Standard.
Likewise, pesticide products containing one or more of these
forms of HCPP may not be distributed or sold after December 1990,
unless the products bear amended labels which comply with the
requirements of this Standard.
The following specific information must appear on the
labeling of all manufacturing and end use MCPP products:
1. Ingredients Statement
The ingredient statement for products must list the
active ingredient as:
ACTIVE INGREDIENT
2-(2-methyl-4-chlorophenoxy) propionic acid %
OR
(Applicable salt or ester) ................. _ %
2-(2-methyl-4-chlorophenoxy) propionic acid
equivalent : ................................ _ %
INERT INGREDIENT (S)
2. Use Pattern Statements
Manufacturing-Use Products
All manufacturing-use products must state that they are
intended for formulation into end-use products for
acceptable use patterns.
End— Use Products
Labeling must specify sites which are listed in the EPA
Compendium of Acceptable Uses. However, no use may be
included on the label where the registrant fails to agree to
comply with the data requirements in TABLE A for that use
pat Cum.
3 . Precautionary Statements
Statements for Manufacturing-Use Products
"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 notifying the sewage treatment
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plant authority. For guidance, contact your State
Water Board or Regional Office of the EPA.
Statements for End-Use Products
Ground Water
"Although highly mobile, in general phenoxy herbicides
such as MCPP are not sufficiently persistent to reach
groundwater from use as specified on product labels.
Most cases of ground water contamination involving
phenoxy herbicides have been associated with
mixing/ loading and disposal sites. Caution should be
exercised when handling MCPP pesticides at such sites
to prevent contamination of water supplies."
Protective Clothing;
"Mixers/ loaders and applicators must wear long pants,
long sleeved shirts and gloves. Persons applying
liquid MCPP products such as sprays are required to use
goggles to cover their eyes." Mixers/ loaders may use
face shield or goggles during mixing/loading
operations, in addition to the protective clothing.
Worker Reentry;
"Do not reenter or permit workers to reenter treated
areas until sprays have dried or dusts have settled."
Nontaroet Plant Species;
Aquatic Uses
"Drift or run-off may adversely affect nontarget
plants. Do not apply directly except as specified on
this label. Do not contaminate water when disposing of
equipment washwaters."
Non-aquatic Uses;
"Drift or run-off may adversely affect nontarget
plants. Do not apply directly to water or wetlands
(swamps, bog, marshes, and potholes). Do not
contaminate washwaters . "
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.A. are subject to certain requirements
for data 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
follow:
A. Manufacturing use products containing this pesticide as the
sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or packaging
listed in Section IV, if they pertain to the manufacturing use
product.
2. The data requirements listed in Tables A and B2
3. The labeling requirements specified for manufacturing use
products in Section IV.
4. Administrative requirements (application forms,
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.
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.
2 Data requirements are listed in the three Tables in
Appendix I of this Registration Standard. The Guide to
Tables in that Appendix explains how to read the Tables.
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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 exemptions, 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 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.
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.
3 If you purchase from another producer and use as the
source of your active ingredient only EPA-registered products,
you are eligible for the 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).
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vi. ^FQUTREMENT 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 registration
of products containing this active ingredient.4
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation" of
a product. "Typical formulation" testing is often required for
ecological effects studies and applies to all products having
that formulation type. These are classed as generic data, and
are contained in Table A.
B. Who must submit? generic data?
All current registrants are responsible for submitting
generic data in resppnse 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 §152.85) to submit
generic data in response to a DCI notice if the registrant who
supplies the active ingredient in his product is complying with
the data request.
If you are granted a generic data exemption, you rely on
the efforts of other persons to provide the Agency with the
required data. If the registrants who have committed to
generate and submit the required data fail to take appropriate
steps to meet the requirements or are no longer in compliance
with this data requirements notice, the Agency will consider
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.
4 Registrations granted after issuance of this Standard will be
conditioned upon submittal or citation of the data listed in
this Registration Standard.
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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 s^bj^i^^ed.?
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.
0. How to comply with PCI requirements.
Within 90 days of your receipt of this Registration
Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1, enclosed) for each of your products. On that form you
must state which of the following six methods you will use to
comply with the DCI requirements:
1. XQU will fl^frffit the data yourself.
2 .J--.Y.OU have entered into an agreement with one or more
registrants to lointlv develop for 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
30
-------
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 PCI. EPA has determined that, as a
general policy, it will not suspend the registration of a
product when the registrant has in good faith sought and
continues to seek to enter into a data development/cost sharing
program, but the other registrants developing the data have
refused to accept its offer. [If your offer is accepted, you
may qualify for Option 2 above by entering into an agreement to
supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification of Attempt to
Enter into an Agreement with other Registrants for Development
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:
31
-------
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(B) in the [name of active ingredient] Registration
Standard upon terms to be agreed or failing agreement
to be bound by binding arbitration as provided by FIFRA
section 3(c)(2)(B)(iii).
The remainder of your offer may not in any way attempt to
limit this commitment. If the other registrant to whom your
offer is made does not accept your offer, and if the other
registrant informs us on a DCI Summary Sheet that he will
develop and submit the data required under the DCI, then you may
qualify for this option. In order for you to avoid suspension
under this method, you may not later withdraw or limit your
offer to share in the burden of developing the data.
In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice in a timely manner. If the other registrant fails to
develop the data or for some other reason would be subject to
suspension, your registration as well as that of the other
registrant will normally be subject to initiation of suspension
proceedings, unless you commit to submit and submit the required
data in the specified timeframe. In such cases, the Agency
generally will not grant a time extension for submitting the
data.
4. You request_fr waiver of the data requirement;. If you
believe that a data requirement does not (or should not) apply
to your product or its uses, you must provide EPA with a
statement of the reasons why you believe this is so. Your
statement must address the specific composition or use factors
that lead you to believe that a requirement does not apply.
Since the Agency has carefully considered the composition and
uses of pesticide products in determining that a data require-
ment applies, EPA does not anticipate that many waivers will be
granted. A request for waiver does not extend the time-frames
for developing required data, and if your waiver request is
denied, your registration may be suspended if you fail to submit
the data. 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 vour oroductfs) for which the data are needed.
32
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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
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
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.
33
-------
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 anfl Reporting Requirements
All data submitted in response to this Notice must comply
with EPA requirements regarding the reporting of data,
including the manner of reporting, the completeness of results,
and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or
included in this Notice or contained in PR Notice 86-5 (issued
July 29, 1986). 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 prqvision upon suspension or cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a OCX 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
34
-------
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.
35
-------
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your
registrations in effect. Product-specific data are derived from
testing using a specific formulated product, and, unlike generic
data, generally support only the registration of that product.
All such data must be submitted by the dates specified in this
Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data are
listed in Table C. As noted earlier, the Agency has decided
that it will not routinely require product-specific data for end
use products at this time. Therefore, Table C may not be
contained in this Registration Standard; if there is no Table C,
you are not required to submit the data at this time.
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section VI.0 through J. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options VI.0.1. (submit data) or
VI.0.6.(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. .
36
-------
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 Registration 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.
37
-------
IX. INSTRUCTIONS FOR SUBMTTTAL
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: MCPP Registration Standard
All submittals in response to this Registration standard
are non-fee items, including 90-day responses, protocols and
waiver requests, data, and revised labeling. Submittals must be
clearly identified as being in response to the Registration
Standard. Under no circumstances may Registration Standard
responses be combined with other types of filings for which fees
are required.
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 FZFRA 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:
-?*, 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).
38
-------
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
-------
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
3. Within the times set fprth 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:
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.
40
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I. DATA APPENDICES
41
-------
TGUIDE-1
GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements
for the pesticides covered by this Registration Standard.
Table A contains generic data requirements that
apply to the pesticide in all products, including
data requirements for which a "typical formulation11
is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
Table C contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 era 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
42
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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.
43
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TGUIDE-3
6. Must additional data b«* ^iifomitted? (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 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 f«">r fflTbffllffSJQn (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.
44
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Generic Data Requirements
Diethanolamine Salt
Table A
for MCPP (Meocprcp] Acid (1) and its Potassium Salt (2),
(3), Dimethylanine Salt (4), and Isooctyl Ester (5)
Test Use
Data Racuirenent Substance Pattern Cnpnlr
43fl3Bfifc«rf"^""r^^^^^
Part 15fl
Product
61-2 -
61-3 -
Does EPA
Have Data Bibliographic
al Iteauired? Citation
Must Additional
Data Be S»frm1tt*yf
Tineframe for
? ffMhmlsfflon
!«
1.120. Suboart C — Product CtvanlstTv
Idsntitv and OriBposition
Description of
Beginning Materials
fliTi rif^fTfl i • 'fV^T* 11*1 nni
Process
TGAI
Disc*is*?iTi of Format !<"** TEAT
of Impurities
Analysis and Certification of
62-1 -
Physical
63-2 -
63-3 -
63-4 -
63-5 -
63-6 -
63-7 -
63-8 -
Preliminary Analysis
nf Pfnr^iy^- fiffflnlcs
All
All
No
•
No
N/A
N/A
YesV
Yes2/
9
9 Months
9 Months
Product incirefl i an****
TGAI
All
No
N/A
Yes3/
12 Months
and Cheroical Characteristics
Color
Physical State
Odor
Malting Point
Boiling Point
Density, Bulk Density
or Specific Gravity
Solubility
TGAI
TGAI
TGAI
TGAI
TGAI
, TGAI
TGAI or PAI
All
All
All
All
All
All
All
No
No
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Yesi/
Yes*/
Yes*/
Ygg4_1j5/
Yes^Lfi/
Yes*/
Yes*/
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
-------
Table A
Generic Data Requirements for MCPP [Meooprop] Acid (1) and its Potassium Salt
Diethanolamine Salt (3), Dimethylamine Salt (4), and Isooctyl Ester (5)
(2),
Test
Use
Does EPA
Have Data
Bibliographic Must Additional Timeframe for
— C —
arv) Chemical Characteristics foont'd)
63-9 - Vapor Pressure
63-10 - Dissociation
Constant
63-11 - Octanol/Water
Partition
Coefficient
63-12 - pH
63-13 - Stability
Other ReguirenvHtts
64-1 - Submittal of Samples
V3KL or BAI All
TGAI or EAI All
PAI All
TGAI All
TGAI All
N/A N/A
Ho
No
NO
No
No
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Yes*/
Yes*/
Yes*/
Yes*/
9 Months
9 Months
9 Months
9 Months
9 Months
No
Note: All - The total number of chemicals.
1/Cfcnplete information must be provided regarding the nature of the process (batch or continuous), relative amounts of
beginning materials and the order in which they are added, chemical equations for each intended reaction, equipment
used to produce each intermediate and the final product, reaction conditions, duration of each step of the process,
purification procedures, and quality control measures. In addition, the name and address of the manufacturer, pro-
ducer, or supplier of each beginning material used in the manufacture of each product must be provided, along with
information regarding the properties of those materials. .
2/A detailed discussion must be submitted regarding all impurities, including nitrosamines, dibenzo-p-dioxins, and
dibenzofurans that are or may be present at > 0.1 percent, based on knowledge of the beginning materials, intended
and side chemical reactions in the manufacturing process, and any contamination during and after production.
-------
Table A
Generic Data Requirements for MCPP [Mecoprop] Acid (1) and its Potassium Salt (2),
Diethanolanine Salt (3), Dimethylamine Salt (4), and Isooctyl Ester (5)
Test
Use
Dees EPA
Have Data Bibliographic
Mist Additional Tinefrane for
Part 158 - Suboart C -
,2/Five or more representative samples must be analyzed for the amount of active ingredient and each impurity including
"toxicologically significant11 inpurities such as dibenzo-p-dioxins and dibenzofurans for uhich certified limits are
required. Complete, detailed descriptions of the analytical methods used must be submitted along with statements of
their precision and accuracy. Reports of preliminary analyses should include for each sample the identity of each
ingredient for which analysis was conducted, the quantity that was found, and the mean and relative standard devia-
tion of reported analytical results. In addition, six samples must be analyzed for presence of nitrosamines by
methods capable of detecting < 1 ppm nitrosamine: two samples must be analyzed shortly after production, two samples
at 3 months after production, and two samples at 6 months after production.
I/Data must be submitted on physicoohemical characteristics (color, physical state, odor, melting point, boiling point,
£» specific gravity, solubility, vapor pressure, dissociation constant, octanol/water partition coefficient, pH, and
-,4 stability) as required in 40 CFR Part 158 Subpart C and more fully described in the Pesticide Assessment Guidelines,
Subdivision D. See Table B for addition requirements for data on physioochemical characteristics of technical products
that are also manufacturing-use products.
5/Data on melting point are required if the technical chemical is a solid at room temperature.
£/Data on boiling point are required if the technical product is a liquid at room temperature.
2/Data on pH are required if the test substance can be diluted or dispersed in water.
-------
Table A
•««MW«MWr • n '• •**• *!•*• • ^^n^^iv^ft.^MMM •«•••» ^-^fimi a ww>^ A ^« ww«*^v*. vyr j • • « i • ^ ^^ m« «•* <•>««•» * «^«MM»««^^w«»M »>^^i» ^ w ^ / V
Diethanolamine Salt (3) , Dimethylamine Salt (4) , and Isooctyl Ester (5)
Data Re..
Test
ouirement Substance
Use
Pattern
Does EPA
Have Data Bibliographic Must Additional
Timeframe for
i1
i 158. 290 — Environpgntal Fate
Deciradation Stxriies — Ia)>
161-1 -
Hydrolysis PAIRA
B
B,D
B
B,D,G
B,D
1
2
3
4
5
Partially 00162656
No 00162656
NO 00162656
No 00162656
. No 00162656
Yes2/
Yes*/
Yes2-/
Yes2/
Yes*/
9 Months
9 Months
9 Months
9 Months
9 Months
Pnotodearadation
161-2 -
45* 161-3 -
OO
161-4 -
Metabol
162-1 -
162-2 -
162-3 -
In Water PAIRA
On Soil TGAI or PAIRA
In Air TGAI or PAIRA
isro Studies — lab
Aerobic Soil PAIRA
Anaerobic TGAI or PAIRA
Soil
Anaerobic TGAI or PAIRA
Aquatic
All
All
-
B
B
B
B,G
B
D
D,G
D
All
All
-
1
2
3
4
5
2
4
5
No
t
No
No2/
No
No
No
No
No
No3-/
No
No
No
Yes
Yes
No2/
Yes
No2/
Yes
Yes
Yes
9 Months
9 Months
27 Months
27 Months
27 Months
27 Months
-------
Table A
ueneric uata requirements EOT nutvv ineuuprupj Acia IJL> ana its rotassiun &«u.t. {&} ,
Diethanolamine Salt (3) , Diaethylamine Salt (4) , and Isooctyl Ester (5)
Test
Data Ite^nl iTStnent S^ita?tanc6
/,
$158.290 — Environnental Fate
Mofahniican «tirti«£ - Tab fcrnt'd)
162-4 - Aerobic TGAI or BftlRA
Aquatic
•
163-1 - Leaching and PAIRA
^ Adsorption/
•^ Desorption
163-2 - Volatility (Lab) TEP
*-0 163-2 - Volatility (Field) TEP
Dissipation Studies - Field
164-1 - Soil TEP
164-2 - Aquatic TEP
(Sediment)
164-3 - Forestry TEP
164-4 - Combination and
Does EPA
Use Have Data Bibliographic
Pattern fttfflli'rSll fr'nuir^l? Citation
D 2 No
D 4 No
D 5 No
All All Partially 00160749
00162403
00162404
NO
- - NO
All All NO
D 2 No
D 4 No
D 5 No
G 4 No
- -
Must Additional
Data Be SuNnitt^rf
Yes
Yes
Yes
Yes*/
Yes4/
Yes3/
No3-/
No3-/
Yes
Yes
Yes
Yes
Yes
No§/
Timeframe for
27 Months
27 Months
27 Months
12 Months
12 Months
12 Months
27 Months
27 Months
27 Months
27 Months
27 Months
Tank Mixes
164-5 - Soil, Long-term
TEP
No
Reserved6-/
-------
Table A
Generic Data Requirements for MCPpl/ [Hoooprop] Acid (1) and its Potassium Salt (2),
Diethanolamine Salt (3), Dimethylamine Salt (4), and Isooctyl Ester (5)
Test Use Have Data Bibliographic Must Additional Timeframe for
Data Reauirement Substance Pattern Chemical Remixed? Citation Data Be Sufcmit±^d? Suhmissirn
S158.290 - Environmental Fate
Accumulation Studies
165-1 - Rotational Crops PAIRA - .No - No3-/
(Confined)
165-2 - Rotational Crops TCP - No - No3./
(Field)
"2 165-3 - Irrigated Crops TCP D 2 No - Yes 39 Months
D 4 No - Yes 39 Months
D 5 No - Yes 39 Months
< 'i
O
165-4 - In Fish TGAI or PAIRA All All No - Yes 12 Months
165-5 - In Aquatic TCP D 2 No - Yes 12 Months
Nontarget D,G 4 No Yes 12 Months
Organisms D 5 No - Yes 12 Months
jt/MCPP is formulated as an acid, salts, or ester. Data are required on each form as indicated by its individual
use pattern (data requirements on MCPP-potassiuu salt will be fulfilled by data on MCPP acid because this
inorganic salt is considered to be interconvertable with the MCPP acid form). Data on MCPP acid will be appli-
cable to the organic salt and ester form only after data on the parent indicate that the chemical dissociates
or degrades from the salt or ester form to the MCPP acid. Additionally, data on the organic salts or ester part
of the formulation will be necessary to support registration. The rate and completeness of the dissociation or
degradation reaction are essential to the development of the environmental fate profile of each registered MCPP
chemical form. The process or processes and the rate at which this reaction occurs as well as any substantial
side reactions are the target of the environmental fate data requirements.
2/The hydrolysis data requirement is only partially satisfied for the acid and potassium salt formulations; the
requirement is not satisfied for the organic salt/ester forms of MCPP.
-------
Table A
Generic Data Requirements for MCPP [Meooprop] Acid (1) and its Potassium Salt (2) ,
Diethanolandne Salt (3) , Diaethylamine Salt (4) , and Isooctyl Ester (5)
Test Use Have Data Bibliographic Mist Additional Timeframe for
Data I^sraent oe Pattern Ra*iip e S"^"vittjed?
§158.290 - Environroeantal Fate (cont'd)
study is not required for the current use patterns.
4/Ihe studies reviewed partially satisfy the adsorption/desorption data requirement for the unaged residues of
MCPP only (acid and potassium salt formulations) . Adsorption/desorption data are required for both the unaged
and aged organic salVester forms of MCPP pesticides.
5/Ihere are no current registered combination or tank mixes for MCPP pesticides.
£/lhe requirement for this study is reserved pending the results of the field dissipation study.
-------
Table A
Generic Data Requirements for. MCPP [Mecoprop] Acid (1) and its Potassium Salt (2),
Diethanolamine Salt (3),. Dimethylamine Salt (4), and Isooctyl Ester (5)
Teat
Use
Does EPA
'Have Data
1 Remixed?
Bibliographic
Citation
Mist Additional Timeframe for
S158.340 - Toxicology
Acute Testing
81-1 - Acute Oral TGAI
Toxicity - Rabbit
81-2 - Acute Dermal TGAI
Toxicity - Rabbit
LT»
r\>
81-3 - Acute Inhalation
Toxicity - Rat
81-4 -
Eye Irritation
- Rabbit
TGAI
TGAI
81-5 -
Dermal Irritation
- Rabbit
TGAI
TGAI
B
B,D
B
B,D,G
B,D
B
B,D
B
B,D,G
B,D
1
2
3
4
5
1
2
3
4
5
81-6 -
Dermal Sensitization TGAI
- Guinea Pig
All
B
B,D
B
B,D,G
B,D
B
B,D
B
B,D,G
B,D
All
All
1
2
3
4
5
1
2
3
4
5
All
Yes
Yes
No
No
No
Yes
Yes
No
No
No
No
Yes
Yes
No
No
No
Yes
Yes
No
No
No
No
00128266
00128266
00128265
00128265
00128267
00128267
00128264
00128264
NO
No
Yes
Yes
Yes
No
No
Yes
Yes
Yes
Yes
No
No
Yes
Yes
Yes
No
No
Yes
Yes
Yes
Yes
9 Months
9 Months
9 tenths
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
-------
Table A
Diethanolamine Salt (3) , . Dimethylamine Salt (4) , and Isooctyl Ester (5)
Data^Recuirement
S158.340 - ToxicolOOV
Acute Testing (oont'd)
81-7 - Delayed
Neurotoxicity - Hen
Subchronic Testing
82-1 - 90-Day Feeding
- Rodent,
U1 - Nonrodent (Dog)
82-2 - 21-Day Dermal
82-3 - 90-Day Dermal
82-4 - 90-Day Inhalation
82-5 - 90-Day Neurotoxicity
Chronic Testing
83-1 - Chronic Toxicity
- Rodent
- Nonrodent (dog)
Test
Substana
i1
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Use
5 Pattern
All
B
B,D
B
B,D,G
B,D
All
All
All
All
All
All
All
Chemic
All
1
2
3
4
5
All
All
All
All
All
All
All
Does EPA
Have Data Bibliographic
fll Rgffllired? Citation
No
Yes 00158359
Yes 00158359
No
No
No
No
No
No -
No
No
.No
No
Most Additional Timeframe for
Dat^ Be Sitfflltt'rt? fifrffiMpP.
Nol/
No
No
No2/
No2/
No2/
Yes 12 Mont
No2/
No2/
Noi/
No2/
No2/
-------
Table A
Generic Data Requiranents for MOPP [Mecoprop] Acid (1) and its Potassium Salt (2),
Diethanolamine Salt (3), Dimethylamine Salt (4), and Isooctyl Ester (5)
Test
Use
Does EPA
Have Data
Bibliographic
:ion
Must Additional Tiaeframe for
(5158.340 - Toxicology
Chronic Testing (cont'd)
83-2 - Onoogenicity
- Rat (preferred)
- Mouse (preferred)
83-3 - Teratogenicity
- Rat
TGAI
TGAI
cn
- Rabbit
83-4 - Reproduction - Rat
2-generation
Mutagenicitv Testing
84-2 - Gene Mutation
Rat
TGAI
TGAI
All
All
All
B
B,D
B
B,D,G
B,D
All
All
B
B,D
B
B,D,G
B,D
B
B,D
B
B,D,G
B,D
1
2
3
4
5
1
2
3
4
5
All
1
2
3
4
5
No
No
Yes
Yes
No
No
No
Yes
Yes
No
No
No
No
00164569
00164569
00044282
00044282
No2/
No2/
No
No
Yes
Yes
Yes
No
No
Yes
Yes
Yes
No2/
Yes
Yes
No
No
No
00123282
00123282
No
No
Yes
Yes
Yes
15 Months
15 Months
15 Months
15 Months
15 Months
15 Months
9 Months
9 Months
9 Months
-------
Table A
Generic Data Requirements for MCPP [Mecoprop] Acid (1) and its Potassium Salt
Diethanolamine Salt (3), Dimethylamine Salt (4), and Isooctyl Ester (5)
(2),
Test
Use
Does EPA
Have Data
H.
Bibliographic
Cit
Must Additional Timeframe for
S158.340 - Toxiooloov I
Mutagenicity Testing (oont'd)
84-2 - Oiromoscnal TOM
Aberration
: 84-4 - Other Mechanisms
Of Mutatenicity
TGAI
cn
en
SPECIAL TESTING
85-1 - General
Metabolism
85-2 - Dermal Absorption
PAI or PAIRA
TGAI
B
B,D
B
B,D,G
B,D
B
B,D
B
B,D,G
B,D
All
All
1
2
3
4
5
1
2
3
4
5
All
All
No
No
No
No
No
Yes
Yes
No
No
No
No
No
00158363
00158363
Yes3/
Yes3-/
Yes
Yes
Yes
No
No
Yes
Yes
Yes
No2-/
Yes*/
12 Months
12 Months
12 Months
12 Months
12 Months
12 Months
12 Months
12 Months
12 Months
Note: Registrants who conduct chronic feeding and/or ohoogenicity studies should inform the Agency in writing of the
dosage levels planned and their reasons for believing that the highest dose approaches or equals the Maximum
Tolerated Dose observed in subchronic or range-finding studies, and must also consult with the Agency to
determine that the appropriate dosage levels are being used in the chronic feeding and/or onoogenicity studies.
If EPA subsequently determines that the study was conducted using a dosage rate that was too low to assess
long-term effects, the study may be deemed not to satisfy the data requirement.
J/MCPP, by virtue of its structure or known toxicity, does not require delayed neurotoxicity studies.
2/This study is not required for the registered use patterns.
3/A Chinese hamster bone marrow cytogenetics study is required on MCPP acid or MCPP potassium salt.
4/A dermal teratogenicity study in the rat may be needed if the results of the dermal absorption study indicate
significant dermal absorption.
-------
Table A
Diethanolamine
Test
r*i • T1* f • i^ l •
Lrcl^cl ivRCiVl j_ft>iiibt5i iL> SuDSwcin
5158.390 - Reentry Protection
132-1 - Foliar Dissipation TEP
132-2 - Soil Dissipation TEP
133-3 - Dermal Exposure TEP
133-4 - Inhalation Exposure TEP
Use
oe Pattern
All
All
All
All
Salt (3) , Dijnethy lamine Salt (4), and
Does EPA
Have Data Bibliographic
Chemical Required? Citation j
V.
All No
All No
All No
All No
Isooctyl Ester (5)
Must Additional
3ata Be Submitted?
NO2/
No2/
No2/
No3/
Timeframe for
Submission
^^^^*™ '^•^"^••••^^•'"•"^^•^•^•fc
27 months
27 months
27 months
Sec. 158.75 - Reouirements for Additional Data
Applicator Exposure Monitor ira
Dermal Exposure, Outdoor TEP
Respiratory Exposure,
Outdoor TEP
Ul
rr\ 5 158. 440 - Sorav Drift
201-1 - Droplet Size TEP
Spectrum
201-1 - Drift Field TEP
Evaluation
All
All
All
All
All No
All No
All No
All No
Yes4/
» m
Yesi/
No5/
No5-/
6 months
6 months
1 /CT^A -C_^4-.~^*-.-. t ^* C1CO OOrt CV».j »«>«.•««.». n»fr.»1 CV>4-^
^/Reentry data are required for commercial turf use. Data must reflect exposure resulting from harvesting
and handling treated turf.
•^/Reserved pending registrant submission and Agency evaluation of complete toxicology data base including dermal
and inhalation toxicity.
4/Sites include commercial home lawns (hose end sprayer, power sprayer, back pack); and commercial turf (ground boom).
Protocols are to be submitted in 6 months.
5/Spray drift data are not required under this Standard at this time because MCPP does not meet the human or
phytotoxicity requirement under §158.142.
-------
Table A
Generic Data Requirements for MCPP [Meooprop] Acid (1) and its Potassium Salt (2),
Diethanolamine Salt (3), pimethylamine Salt (4), and Isooctyl Ester (5)
Data Requi
Test Use
Substance Pattern
Does EPA
Have Data Bibliographic
Itaoutrad? OitoHc»i
Must Additional
Data Be Submitted?
Tinefrane for
Sutanissicn
S158.490 - Wildlife and Aquatic praanisms
i
Avian and Manual ian Testing
171-1 - Acute Avian Oral TGAI
Toocicity
171-2 - Avian Subacute
Dietary Toocicity
- Upland Game
Bird
TGAI
ui
- Waterfowl
171-3 - Wild Mamnal Toxicity TGAI
171-4 - Avian Reproduction TGAI
- Upland Game Bird
and Waterfowl
171-5 - Sinulated and Actual TEP
Field Testing
— Mamnals and
Birds
B
B,D
B
B,D,G
B,D
B
B,D
B
B,D,G
B,D
B
B,D
B
B,D,G
B,D
All
All
1
2
3
4
5
1
2
3
4
5
1
2
3
4
5
All
All
Yes
No7-/
• No
No
No
Yes
No7-/
No
No
No
Yes
No7-/
No
Yes
No
N/Al/
No
B
B,D
B
B,D,G
B,D
1
2
,3
4
5
No
No2/
No
No
No
40116101
40116101
164095
28295
No
No7-/
Yes
Yes
Yes
No
No7-/
Yes
Yes
Yes
No
No7-/
Yes
No
Yes
No
Reserved2-/
9 Month
9 Month
9 Month
9 Month
9 Month
9 Month
9 Month
9 Month
Reserved2/
Reserved4-*7-/
Reserved4-/
Reserved4-/
-------
Table A
Generic Data Requirements for MCPP [Maooprop] Acid (1) and its Potassium Salt (2),
Diethanolamine Salt (3), .Dimethylamine Salt (4), and Isooctyl Ester (5)
Data ftecuireraent
Test
Substance
Use
Pattern
Does EPA
Have Data
Chemical
Bibliographic
Citatim
Mist Additional Tiaeframe for
€158.490 - Wildlife and Acuatic Oraanisms
Aquatic Organism Testing
172-1 - Freshwater Fish
Toxicity
- Ooldwater Fish TSAI
Species
Ooldwater Fish TEP
Species
00
Wannwater Fish TGAI
Species
Wannwater Fish TEP
Species
172-2 - Acute Toxicity TGAI
to Freshwater
Invertebrates
B
B,D
B
B,D,G
B,D
B
D
B
B,D,G
D
B
B,D
B
6,0,6
B,D
B
D
B
D
D
B
B,D
B
B,D,G
B,D
1
2
3
4
5
1
2
3
4
5
1
2
3
4
5
1
2
,3
4
5
1
2
3
4
5
Yes
Ho/./
Ho
No
Ho
Ho
Ho
Ho
Ho
Ho
Ho
No7-/
Ho
Ho
Ho
Ho
Ho
Ho
Ho
Ho
Ho
Ho2/
Ho
Ho
Ho
158366
Ho
Ho7-/
Yes
Yes
Yes
Ho3/
Yes
Yes
Yes
Yes
Ho2/
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Ho7-/
Yes
Yes
Yes
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
-------
Table A
Generic Data Requirements for MOPP [Meooprop] Acid (1) and its Potassium Salt (2),
Diethanolamine Salt (3), Dimethylamine Salt (4), and Isooctyl Ester (5)
Test
Use
Does EPA
Have Data Bibliographic
Must Additional Timeframe for
§158.490 - Wildlife and Aquatic Organisms
172-2 - Acute Toodcity TEP
to Freshwater
Invertebrates
(oont'd)
B
D
B
D
D
1
2
3
4
5
No
No
No
No
No
Ul
172-3 - Acute Toxicity TGAI
to Estuarine and
Marine Organisms TEP
' - Fish, Mollusk,
*• Shrimp
172-4 - Fish Early Life TGAI
Stage, and Aquatic
Invertebrate Life
Cycle
172-5 - Fish Life Cycle TGAI
172-6 - Aquatic Organism TGAI
Accumulation
- Crustacean
- Fish
- Insect Nymph
- Mollusk
172—7 — Simulated or TEP
Actual Field
Testing - Aquatic
Qcgamsms
All
All
All
Yea
Yes
Yes
9 Months
9 Months
9 Months
All
All
All
No
No
No
All
All
All
All
.No
Reserved^/
N/A6/
All
All
No
-------
Table A
Generic Data Requirements for MCPP [Macoprop] Acid (1) and its Potassium Salt (2),
Diethanolamine Salt (3), Dimethylamine Salt (4), and Isooctyl Ester (5)
S158.490 - Wildlife and Aoiatic Organisms Footnotes
All = The total number of ERA registered uses or total number of chemicals depending on the column.
I/This study is currently not required.
2/Reserved pending receipt and evaluation of environmental fate studies.
^/Formulated product testing is not required because this pesticide has no aquatic uses and the maxim an estimated
environmental concentration is not greater than the lowest l£$Q.
4/Reserved pending receipt and evaluation of acute toxicity and environmental fate studies.
^/Reserved pending receipt and evaluation of fish early life stage or invertebrate life cycle studies, if required.
£/See Environmental Assessment Chapter for data requirements.
2/Data for MCPP acid is sufficient for the potassium salt.
O
-------
Table A
ww^««a> at^f BV^WB^ «iii i j^iiM i» • ««••*•«• •«•«* ^»*»i . • •»<•» • ^» ^i»^^»»i»i^ ^i»j r • » ^ r j ^« * * " ~~ -* ^^"^r * TLHT T.M n r • — • — I m****^* \^ / V
Diethanolamine Salt (3) , Dimethylamine Salt (4) , and Isooctyl Ester (5)
Od^d F^Oll 1 T^TO^HTit
< 158. 540 - Plant Protection
121-1 - TARGET AREA
PHYTOTOXIdTY
NQNEARGET AREA PHYTDTOXICITY
TIER I
122-1 - Seed Germination/
Seedling Bnergence
122-1 - Vegetative Vigor
122-2 - Aquatic Plant
Growth
TIER II
123-1 - Seed Germination/
jp^yy^ | ^ fy¥ plH^T^'iT^nO^
123-1 - Vegetative Vigor
123-2 - Aquatic Plant
Test
Suh^ptarf*?
1
TEP
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Use
Pattern
All
All
All
All
All
All
All
Does EPA
Have Data Bibliographic Must Additional Timeframe for
1 'ttKlhifill f(*'ll^riffY? Citation Data Be S'lfaroi t~ted? S'llTnipffion
-
All N/A - No
All No - No
All No - No
All No - No
All No - Yes 9 Months
All No - Yes 9 Months
All No - Yes 9 Months
Growth
-------
Table A
Generic Data Requirements for MOPP [Meooprop] Acid (1) and its Potassium Salt (2) ,
Diethanolamine Salt (3) , Dimethylamine Salt (4) , and Isooctyl Ester (5)
Test Use Have Data Bibliographic Must Additional Timefrane for
Data Reouireroent Substance Pattern QigiBi«"g*i R^MJr?d? Citation _ Data Be SuNnitted?
/(
$158.540 - Plant Protection i
TIER III
124-1
124-2
All -
- 'lerrescriai rieia 'no?
Study
- Aquatic Field TEP
Study
The total number of use patter
All All
All All
ns or total number
NO
No
of chemicals. ^VTH
Reserved*/
ReservedV
aiding on the column.
I/Reserved pending receipt and evaluation of Tier II plant studies.
ON
ro
-------
ON
Table A
Generic Data Requirements for MCPP [Neooprop] Acid (1) and its Potassium Salt (2),
Diethanolamine Salt (.3), Dimethylamine Salt (4), and Isooctyl Ester (5)
Dataj
tecuirewent
Test Use
Substance Pattern
Does EPA
Have Data Bibliographic Must Additional Tineframe for
qraniral Rynlr^l? citation Data P? ft^i™-^? gnHmigainn
S 158. 590 - Nontarqet Insect '
NONTARGEf INSECT TESTIN? - PPTLnWTQBf?
141-1
141-2
141-4
141-5
- Honey Bee Acute
Contact Toxicity
- Honey Bee - Toxicity
of Residues on
Foliage
- Honey Bee Subacute
Feeding Study
- Field Testing for
Pollinators
TGAI B
B
B
B
TEP B
B
B
B
[Reserved]^/
TEP B
B
B
B
2
3
4
5
2
3
4
5
2
3
4
5
NoV
tto
No
No
NoV
No
No
No
*
NoV
No
No
No
NoV
Yes
Yes
Yes
NoV
Nol/
Nol/
NoV
Nol/
Nol/
Nol/
9 Months
9 Months
9 Months
142-1 - Acute Toxicity to
Aquatic Insects
142-1 - Aquatic Insect
Life cycle Study
142-3 - Simulated or Actual
Field Testing for
Aquatic Insects
[Reserved]^/
[Reserved]3-/
[Reserved]3-/
-------
Table A
Generic Data Requirements for MCPP [Mecoprop] Acid (1) and its Potassium Salt (2),
Diethanolamine Salt (3), Dimethylamine Salt (4), and Isooctyl Ester (5)
Test
Use
Does EPA
Have Data Bibliographic
Must Additional Timeframe for
6158.590 - Nontaroet Insect
143-1 - NONTftRGEy INSECT [Reserved]3-/
Thru TRHTIMG — PREDATORS
143-3 AND PARASITES
^./Requirement deferred pending evaluation of data from the acute contact test.
2/Reserved pending development of test methdology.
3yResexved pending Agency decision as to whether the data requirement should be established.
< 4/Data for MCPP acid is sufficient for the potassium salt.
-------
Table B
CN
Diethanolamine Salt (3), Dimethylamine Salt (4), and Isooctyl Ester (5)
Test Use
Does EPA
Have Data Bibliographic
1 RMlirefl? Citation
Must Additional
Data P? frihnUt**!
Timefrane for
? gMhmigffJTn
§158 — -^tfrsirt c — Product CtKtnistrv
Product
61-1 -
61-2 -
61-3 -
Analysis
62-1 -
62-2 -
62-3 -
Physical
63-2 -
63-3 -
Mpntitv and Ocuposition
Product Identity
Ingredients
Description of Beginning
Materials and Manufac-
turing Process
Discussion of Formation
of Impurities
t and Certification of Proc
Preliminary Analysis
of Product Samples
Certification of
Ingredient Limits
MP All
MP All
MP All
luct Ingredients
MP All
MP All
Analytical Methods MP All
to Verify Certified
Limits
and Ch*Tflir?l Clwract"<*ris£.ics
Color
Physical State
MP All
MP All
No N/A
No N/A
No N/A
No N/A
No N/A
No N/A
No N/A
No N/A
YesV
Yes2/
Yes3/
Yes*/
Yes§/
Yes6-/
Yes2/
Yes2/
9 Months
9 Months
9 Months
12 Months
12 Months
12 Months
9 Months
9 Months
-------
Generic Data ft
Diethand
Data!
T
P'jilrpiwpn*"*' fn
Lamine Salt (3
able B
r MOPP [Mecoprop] Acid (1) an
), Diaethylamine Salt (4), an
Does EPA
Test Use Have Data
fcTur*invant S>ifr7tanoe Pattern Ctwnioal RfiCMired?
« , 1 , A «-• V*k . i ,.1 , * — * * "
158 "* rrtimfini- ^ ^ fi^n ff-iCrtj vm^^uBi
i
Fhvsical and CtwmLoal Chanvrfarij
63-4
63-7
63-12
63-14
63-15
63-16
63-17
63-18
63-19
63-20
- Odor
- Density, Bulk Density,
or Specific Gravity
-pH
— Oxidizing or Reducing
Action
- Flaooability
- Explodability
- Storage Stability
- Viscosity
- Miscibility
- Corrosion
by
sties (cart
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
t'd)
All
All
All
All
All
All
All
All
All
All
No
No
No
No
No
No
No
No
No
No
Bibliographic
Citation
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
M i t~c? Pontiffs i \Bn f**
d Isooctyl Ester
Must Additional
Data Be ^ubmittei
Yes2/
Yes2/
YeslJB/
Yes2/
Yes^-2/
yggJxiP/
Yes2/
Yes2/
Yes2a2/
Yes7-/
alt (2),
(5)
Timeframe f
j? s^if^\issirn
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
15 Months
9 Months
9 Months
15 Months
Characteristics
Ot
64-1 - Submittal of Sanples
N/A
N/A
N/A
N/A
No
-------
Table B
Generic Data Requirements for MCPP [Hecoprop] Acid (1) and its Potassium Salt (2) ,
Oiethanolandne Salt (3) , Dimethylamine Salt (4) , and Isooctyl Ester (5)
S158 - Subpart C - Product flyjffllfffoY Footnotes
Note: All = Ihe total number of chemicals.
j/lne product name, chemical name! (Chemical Abstracts Index of Nomenclature or other well-defined name) , nominal
concentration, certified limits, Chemical Abstracts Service (CAS) Registry Number, and purpose of each active
ingredient and each intentionally added inert must be provided for each manufacturing-use product. The name and
upper certified limit must also be provided for each impurity or group of impurities for which a certified limit
is required. The information on ingredient limits must be submitted on ERA Form 8570-4 (Rev. 2/85) .
2/Oomplete information must be provided regarding the nature of the process (batch or continuous) , relative amounts
of beginning materials and the order in which they are added, chemical equations for each intended reaction,
equipment used to produce each intermediate and the final product, reaction conditions, duration of each step of
the process, purification procedures, and quality control measures. In addition, the name and address of the
manufacturer, producer, or supplier of each beginning material used in the manufacture of each product must be
provided, along with information regarding the properties of those materials.
2/A detailed discussion must be submitted for each manufacturing-use product regarding all impurities that are or
may be present at > 0.1 percent, based on knowledge of the beginning materials, intended and side chemical
reactions in the manufacturing process, and any contamination during and after production. A discussion regarding
the possible presence of nitrosamines, dibenzo-p-dioxins, and dibenzofurans from any sources in the product are
ON also required.
"^ 4/Five or more representative samples must be analyzed for the amount of active ingredient and each impurity for which certi
required. Complete, detailed descriptions of the analytical methods used must be
submitted along with statements of their precision and accuracy. Reports of preliminary analyses should include
for each sample the identity of each ingredient for which analysis was conducted, the quantity that was found,
and the mean and relative standard deviation of reported analytical results. In addition, six samples must be
analyzed for presence of nitrosamines by methods capable of detecting < 1 ppa: two samples must be analyzed
shortly after production, two samples at 3 months after production, and two samples at 6 months after production.
j>/Upper and lower limits for each active ingredient and intentionally added inert ingredient, and upper limits for
each impurity present at > 0.1 percent (w/w) and each additional "toxicologically significant" impurity such as
dibenzo-p-dioxins and dibenzofurans that may be present at < 0.1 percent must be certified for each manufacturing-
use product. 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 the procedures used. Certifications must be submitted on
ERA Form 8570-4 (Rev. 2/85) .
ig/Ftor each manufacturing-use product, analytical methods must be provided to quantify each active ingredient and
each "toxicologically significant11 impurity. Each method must be accompanied by validation data indicating its
accuracy and precision. These methods must be suitable for enforcement of certified limits.
-------
Table B
Generic Data Requirements for MCPP [Meooprop] Acid (1) and its Potassium Salt (2),
Diethanolamine Salt (3), Oimetnylamine Salt (4), and Isooctyl Ester (5)
§153 - s*i>"fwt C - Product rTfflTliffVry Ppotnoteg (cont'd)
2/Quantitative data must be submitted on physicochemical characteristics of each manufacturing-use product (color,
physical state, odor, specific gravity, pH, oxidizing/reducing action, flamnability, explodability, storage
stability, viscosity, miscibility, and corrosive characteristics) as required in 40 CFR 158.190 and more fully
described in the Pesticide Assessment Guidelines, Subdivision D. See Table A for additional requirements for
data on physicochemical characteristics of technical products that are also manufacturing-use products.
fi/Data on pH are required if the test substance can be diluted or dispersed in water.
9/Data are required on the flashpoint if the product is or contains a combustible liquid.
IP/Data are required if the product contains any potentially explosive ingredients.
H/Data on viscosity are required if the product is a liquid.
12/Data on miscibility are required if the product is an emulsif iable liquid and is to be diluted with petroleum
solvents. :
ON
-------
TABLE B
Diethanolamine Salt, Dimethylamine Salt and Isooctyl Ester
Bibliographic Must Timeframe
Test Use Does EPA Citation Additional Data for
Datv« p*ar»Hr«i*»rit S"**f*~«»ice Pat*"*»rTB Clvt"^c;»1— Have Da*"3? fMRID) Be Submitted? SufcmipsiTi
Sec.
Acute
81-1
81-2
81-3
81-4
81-5
158.340 Toxiooloov
Testing
- Acute
- Acute
- Acute
!
Oral - Rat
Denial - Rabbit
Inhalation - Rat
- Eye Irritation - Rabbit
- Dermal Irritation -
MP
MP
MP
MP
MP
All
All
All
All
All
All
All
All
All
All
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
9 Months
9 Months
9 Months
9 Months
9 Months
81-6 -
Rabbit
Dermal Sensitization -
Qiin pig
MP
All
All
No
Yes
vO
9 Months
-------
II. LABELING APPENDICES
70
-------
SUMMARY- 1
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 15 6. 10 (f)]
71
-------
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 156T±0(h)(1)(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)(1)(i)].
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement of
practical treatment (first aid or other) shall appear on the
label of pesticide products in toxicity Categories I, II, and
III. [40 CFR 156.10(h)(l)(iii)]
72
-------
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)(l)(iii)].
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together on
the label under the heading "PRECAUTIONARY STATEMENTS." The
preferred location is at the top of the side or back panel
preceding the directions for use, and it is preferred that
these statements be surrounded by a block outline. Each of the
three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR 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 156.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria in
the PHYS/CHEM Labeling Appendix. The requirement is based on
the results of the flashpoint determinations and flame extension
tests required to be submitted for all products. These
statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no signal word is used
in conjunction with the flammability statements.
Item 9AV~ RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that all pesticide formulations/uses be classified for
either general or restricted use. Products classified for
restricted use may be limited to use by certified applicators or
persons under their direct supervision (or may be subject to
other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
75
-------
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.
.fication Label i:
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)
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.
74
-------
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 LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed.collateral labeling. Such labeling may not bear
'claims or representations that differ in substance from those
accepted in connection with registration of the product. It
should be made part of the response to this notice and
submitted for review.
76
-------
SUMMARY-7
LABELING
OF THE FIFRA, AS AMENDED
-vl
ITEM
1
2
o
4
c
6A
6B
*
7
7A
7B
TARFI FTFMFT7r
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
MlJjrodUCtS
All products
All products
All products
All products
All products
Liquid products
where dosage is
given as Ibs.
All products
All products
All products
PLACEMENT
REQUIPRP
Front panel
None
None
None
None
Front panel
e
Front panel
Front panel
•
Front panel
Front panel
CN IAPEL
PREFEPPEP
Center front
panel
Bottom front
panel or end
-------
SUEMARY-8
TATWT.TKT; OTraiREMEMTS OF THE FIFRA. AS AMENDED (cont'd)
ITEM
7C
7D
7E
8
8A
8B
TAKFT, PT.FMFTTP
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
hazards
APPLICABILITY
OF REQUIREMENT
All products
whicfi 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
PL?¥Tfl«H\rr
REOUIP^D
Front panel
Category I; .'
Front panel
unless refer-
ral statement
is used.
Others;
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None
ON LABEL
PREFERRED
Both in close
proximity to
signal word
Front panel
for all
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
i
OMdENTS
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 acolicable.
-------
SUMMARY-9
REQUIREMENTS OF THE FIFRA. AS AMENDED (cont'd)
ITEM
8C
9A
9B
10A
10B
IOC
LABEL FT.™n^rr
Hiysical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
1502F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Aaencv
All products
All products
PLAC/QMQfT,
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
ON IAPET- |
l^Kt^'W^HJl
'Same as above
»
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
sional word.
Required statement is:
"It is a violation of Federal law
to use this product in a manner
inconsistent with its labeling."
Must be set apart and clearly distin-
guishable from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
-------
Criteria
PHYSICAL-CHEMICAL HAZARDS
Reouired Label Statement
I. Pressurized Containers
A.
Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B.
Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
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.
c7"~Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Extremely flammable.
Contents under pressure.
Keep away from fire,
sparks, and heated
surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents
under pressure. Keep
away from heat, sparks,
and flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do
not puncture or incine-
rate container. Exposure
to temperatures above-
130°F may cause bursting.
Extremely flammable.
Keep away from fire,
sparks, and heated
surfaces.
Flammable, keep away
from heat and open flame.
Do not use or store near
heat and open flame.
None required.
30
-------
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.
81
-------
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
domestie~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."
82
-------
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 Tvoe
Statement
! Non-aerosol products
! (bottles, cans. Tars)
J Non- aerosol
! (baas)
j Aerosol
i
products
products
[Do not reuse container (bottle, can, jar).
[Rinse thorouahlv before discarding in trash.
JDo not
i
' Replace
j trash.
reuse bag
cap
Do
and
not
Discard
bag
in
trash.
discard containers in
incinerate or puncture.
2. All other products must bear container disposal
instructions, based on container type, listed below:
Container Tvoe
Statement
Metal
containers
(non-aerosol)
[Triple rinse (or equivalent). Then offer
ifor recycling or reconditioning, or puncture
land 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
land dispose of in a sanitary landfill, or
'incineration, or, if allowed by state and
i
I local authorities, by burning.
!stav out of smoke.
If burned,
Glass containers
{Triple rinse (or. equivalent). Then dispose
|of in a sanitary landfill or by other
!approved state and local procedures.
Fiber drums
with liners
{Completely empty liner by shaking and
!tapping sides and bottom to loosen clinging
I particles. Empty residue into application
I equipment. Then dispose of liner in a
I sanitary landfill or by incineration if
iallowed by state and local authorities.
|If drum is contaminated and cannot be
! reused^-/, dispose of in the same manner.
Paper and
plastic bags
[Completely empty bag into application
[equipment. Then dispose of empty bag in
I 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).
V Manufacturer may replace this phrase with one indicating whether
and how fiber drum may be reused.
83
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III. BIBLIOGRAPHY APPENDICES
84
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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 viith 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. Wheneve.r 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.
85
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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:
'i
(1) Submission Date. The date of the earliest
known submission appears immediately
following the word "received."
(2) Administrative Number. The next element,
immediately following the word "under," is
the registration number, experimental use
permit number, petition number or other
administrative number associated, with the
earliest known submission.
(3) Submitter. The third element is the
submitter, following the phrase "submitted
by." When authorship is defaulted to the
submitter, this element is omitted.
(4) Volume Identification (Accession Numbers).
The final element in the trailing parentheses
identifies the EPA accession number of the
volume in which the original submission of
the study appears. The six-digit accession
number follows the symbol "CDL," standing for
"Company Data Library." This accession
number is in turn followed by an alphabetic
suffix which shows the relative position of
the study within the volume. For example,
within accession number 123456, the first
study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-
AA.
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
f Citations Considered to be Part of the Data Base Supporting
Registrations Under the MCPP Standard
M.8IB Gitatign
OOO28295 Ross, D.B.; Burroughs, S.J.; Roberts, N.L. (1974) The Acute Toxic-
ity (LC50:) of Mecoprop Technical (4OV. as Dimethylamine Salt
Solution) to Mallard Duck. (Unpublished study received Jul 20,
1976 under 2217-624; prepared by Huntingdon Research Centre,
submitted by PBI-Gordon Corp., Kansas City, Kans.; CDL:235458-B)
00044282 Irvine, L.F.H. (1980) Mecoprop Oral Teratogenicity Study in the
Dutch Belted Rabbit: Report No. i«738R-277/5. (Unpublished study
including submitter summary, received Aug 28, 198O under 2217-
EX-2; prepared by Hazleton Laboratories Europe, Ltd., England,
submitted by PBZ-Gordon Corp., Kansas City, Kans.; CDL:243169-A)
00123282 Carere, A.; Ortali, V.; Cardamone, G.; et al. (1978) Microbio-
logical mutagenicity studies of pesticides in vitro. Mutation
Research 57:277-286. (Also in unpublished submission received
Dec 9, 1982 under 464-5O2; submitted by Dow Chemical U.S.A.,
Midland, MI; CDL:248984-B)
00128264 Wolfe, G.; Shults, S.; Killeen, J.; et al. (1982) Primary Dermal
Irritation Study in Albino Rabbits with 2-(2-Methy1-4-chlorophe-
noxy)propionic Acid: Report Document No. 521-5TX-81-0165-002.
(Unpublished study received May 2, 1983 under 39335-2; prepared
in cooperation with Hazleton Laboratories America, Inc., submit-
ted by Diamond Shamrock Agricultural Chemicals, Tuscaloosa, AL;
CDL:250089-A)
00128265 Wolfe, G.; Shults, S.f Killeen, J.; et al. (1982) Acute Dermal Tox-
icity Study in Albino Rabbits with 2-(2-Methyl-4-chlorophenoxy)
propionic Acid (MCPP): Report Document No. 521-5TX-81-0163-OO2.
(Unpublished study received May 2, 1983 under 39335-2; prepared
in cooperation with Hazleton Laboratories America, Inc., submit-
ted by Diamond Shamrock Agricultural Chemicals, Tuscaloosa, AL;
CDL:2SOOS9-B)
00128266 Wolfe, G.; Shults, S.; Killeen, J.; et al. (1982) Acute Oral Toxic-
ity (LD50) Study in Rats with 2-(2-Methyl-4-chlorophenoxy)propi-
onic Acid (MCPP): Report Document No. 521-5TX-81-0162-002. (Un-
published study received May 2, 1983 under 39335-2; prepared in
cooperation with Hazleton Laboratories America, Inc., submitted
by Diamond Shamrock Agricultural Chemicals, Tuscaloosa, AL; CDL:
250089-C)
87
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the MCPP Standard
MR1P. Citation
4
00128267 Wolfe, G.I Shults, S.f Kill MR, J.| et al. (1982) Primary Eye Irri-
tation Study in Albino Rabbits with 2-(2-Methyl-4-chlorophenoxy>
propionic Acid (MCPP)i Report Document No. 521-5TX-81-0166-O02.
(Unpublished study received May 2, 1983 under 39335-2; prepared
in cooperation with Hazleton Laboratories America, Inc., submit-
ted by Diamond Shamrock Agricultural Chemicals, Tuscaloosa, AL;
CDL:250089-D)
OO15B359 Kirsch, P. (198S) Report on the Study of the Toxicity of MCPP in
Rats after 3 Months Administration in the Dieti Project No.
3150047/8303. Unpublished study prepared by BASF Aktiengesell-
scnaft. 376 p.
OO158363 Engelhardt, G.; Gelbke, H. (1985) Cytogenetic Investigations in
Chinese Hamsters after a Single Oral Administration of MCPP:
Bone Marrow Chromosome Analysisi Project No. 16MO047/8307.
Unpublished study prepared by BASF AG. 35 p.
OO158366 Munk, R.; Gelbke, H. (1984) Rainbow Trout (Salmo gairdneri Rich.):
Report on the Study of the Acute Toxicityi CMPP (Mecoprop)-
Racemat. Unpublished study prepared by BASF Aktiengesellschaft.
18 p.
0016O749 Obrist, J. (1986) Determination of the Mobility of Mecoprop in
Selected Soils by Soil Thin Layer Chromatography: Final Report:
Study No. 6015—321. Unpublished study prepared by Hazleton
Laboratories America, Inc. 71 p.
OO1624O3 Obrist, J._<1986) The Absorption/Desorption of Mecoprop on Repre-
sentative Agricultural Soilsi Final Reports Study No. 6O15-324.
Unpublished study prepared by Hazleton Laboratories America,
Inc. 54 p.
O01624O4 Obrist, J. (1986) Determination of the Mobility of Soil-aged Meco-
prop Residues by Soil Thin Layer Chromatographys Final Report:
Study No. 6015-322. Unpublished study prepared by Hazleton Lab-
oratories, Inc. 52 p.
OO162656 Obrist, J. (1986) Photodegradation and Hydrolysis of Mecoprop in
Aqueous Buffers Final Report: Study No. 6015-320. Unpublished
study prepared by Hazleton Laboratories America, Inc. 131 p.
-------
- OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the MCPP Standard
M.B12 eitaUSQ
00164093 Grimes, J. (1986) MCPPi A Dietary LC50 Study with the Mallard:
Project No.3 218-1O3. Unpublished study prepared by Wildlife
International Ltd. 16 p.
00164569 Irvine, L. (1980) Mecoprop Oral Teratogenicity Study in the Rat:
Report No. 1993-277/7b. Unpublished study prepared by Hazleton
Laboratories Europe Ltd. 171 p.
401161O1 TPH Committee (1986) Reponse to Data'Call-in on Mecoprop o-f March
22, 1985i Toxicology Data. Unpublished compilation. 105 p.
89
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V. FORMS APPENDICES
-------
EPA Form 8580-1
OMB Approval NO. 2070-0057
Expires 11/30/89
FIFHA SECTION 3(CJ(2H8I SUMMARY SHEET
*O
MOOUCT NAMf
APPLICANT'S MAMi
OATl GU'OANCi DOCUMENT l$JUtO
With motet to d« rtouiftmttit to Mbrmt "t*«i*fic~ dttt Hnpoari by tfw FlMA OKlion 3(U(2KI> "Otict conitmtd m tit rtdrtnctd
Gwdtnct Oocumtnt. I tn r«MO«*i«0 MI in* «t dm MI t twntly ntnntr to »titti ffl fellowtnf r«quir«fi«ntt « tnt tm proctourn I «nH w« dtmttt «iti<*« Crouo. OECO
Cntm«ali T«nui| Proonmmt. I tncJoa m« protocol! tlui I «ntt «•:
Attach separate page with a list of the data requirements your
company agrees to satisfy.
Q 1 I h**« tnnrtd mto tn tortomtnt «*tn ont or mort otntr rtfotnnti «n4tf FIFMA MCtion )(C)(2)(ll(ul to atitty ttt tollswing dtu
r*4ummtna Tht ttra. tnd tny rtquirtd protocoll. w«U bt wommtd to E'A by:
NAMt O*
MEClSTMANT
Attach list of data requirements
Q1. I tnciott t cempitttd ~Ctni<«Jtion of Antmpt to Enttr into in A(rttmmrMtKOtntr Mtt
-------
EPA Form 8580-6
OMB Approval No. 2070-0057
Expires 11/30/89
certify £LL
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I am duly awfftontod to roproMnt th* following firmdl who ara ubjact to Ota raquwa*
mon« of a None* undar Flf RA Soaion 3(cl(2)(8) eontainad in aGuidanea Document
to Mibmit data concarnino, tha activa mgradiant:
QUIOAMCI OOCUMINT OATf
ACTlVt IMQNCOltMT
NAJttt Of PIMM
NUMMf M
fThn firm or group of firm« n rafefrad to batew n "my firm".!
2. My firm ii willing to dawloo and Kibmit OM data a§ raquirad by that Not«a. if naoraary. Howavar. my Won would profar to antar
into an aoreamant with ona or mora othar ragtnranu to davalop jointly, or to ihara m tha cost of dawJopina. tha following r«quirad
itamsordata: . .
3. My firm tm off and in writing to anon into udi on aoraomam. Copiai of tna off an m maenad. That offtr •• irrtvocaola and indudad an offtr to tn
bound by an •rtrtm.on demon undtr FIFNA Saction 3(e)(2)(l)(iii) if finat toriamant on •)! ctntii could not ba rtocltad ottianaua Tha offtr •« mada
to mt followmj (irm(i) on int foilowu«« dota<():
NAMC OP PIMM
OATI OP OPPCM
now»^»^r. npnt QT tnoia nimm aoeoptad my onar.
4. My firm roquavu that EPA net tuipond tht r«|i(tration(i| of my firm'i prodwetdl. if any of tha firm namad m paraqroph (3) tbow
"«*« aoraad to oubmit ttt* d«U linad in pafigroph (21 abow in aooordaneo with tha Notiot. I undanund EPA will promptly inform
ma whcthor my firm mutt wbmit data to avoid •itpontion of iti ra«inr«tion(i| undar FIFRA Saction 3(Ci(2)(6). (Thti nattmam
do« not apply to applwant* for ntw proouctkl I •** EPA parmiuion to dudota OM« futamant upon roojwart.
TT^IO MAM«
OATI
92
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CMS Approval Nt
2070-0(
Expires 11/30/i
PRODUCT SPECIFIC DMA REPORT
EPA Reg.
Date.
Guidance Document for.
Registration
Subpart C
PMJAX.T
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
Mama of ToSt
Identity of
Statement of
composition
Discussion of
formation of
Preliminary
- Certification of
limits
Analytical methods
for enforcement
liUTUt5
Color
FhvsicflJ st-at-e
Odor
MeltiryT T?QUI£
Boilina point
Density, buUc-
density, or
i_ specific cnravitv
"^SSlubilitv
VflPT?r Dressure
Dissociation
Octanol/water
partition
coefficient
Test not
required
for my
M_u>M_A «*-»«.
plOuULu
listed
above
(check
below)
I am complyinc
rta^a r*^TUilT9niS
Citing pfujj
Number or
EPA, Accession
Number
1
.
"
•
] with
SltS tY
^i iVwnj 4»
suQnit-
ting
Data
(At-
i
(For EPA Use Only)
Accession Numbers
•
63-12
CH
EPA Form 8580-4
93
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Approval Nb.
2070-005
Empires 11/30/89
EPA Reg. No..
PFCCUCT SPECIFIC DA3A REPORT (cont'd)
Date
Guidance Document for
Registration
Subpart C
wtajixjcr
CHEMISTRY
(cont'd)
63-13
63-14
63-15
63-16 j
63-17 __,
63-18
63-19
63-20
63-21
Sec. 158.340
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
81-7
Name of Test
Stabi J.itv
Oxidizing/reducing
Flanitpb.i ] jfY
Expl
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