>EPA
United States
Environmental Protection
Agency
Pesticides and
Toxic Substances
(H-7501C)
540/RS-89-069
Registration Standard For
Pesticide Products
Containing MCPA
As The Active Ingredient
^Guidance for the rereaistrati on
'of pesticide products containinq
MCDA as the active ingredient.
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OMB Control NO. 2070-0057
Expires November 1989
GUIDANCE
FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
MCPA (2-Methyl-4-chlorophenoxyacetic Acid)
MCPA, Sodium Salt
MCPA, Dimethyanolamine Salt
MCPA, Dimethylamine Salt
MCPA, Butoxyethyl Ester
MCPA, Butyl Ester
MCPA, Isobutyl Ester
MCPA, Isooctyl Ester
MCPA, Isopropyl Ester
AS THE ACTIVE INGREDIENT
CASE NUMBER 0017
September 1989
OPP
CHEMICAL
CODE
030501
030502
030511
030516
030553
030556
030562
030563
030566
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
Printed on Ktcycled Pai
tper
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. Also known as the Reference
Dose or RfD.
a.i. active ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CSF Confidential Statement of Formula
EEC Estimated Environmental Concentration. The estimated
pesticide concentration in an environment, such as a
terrestrial ecosystem.
EP End Use Product
EPA U.S. Environmental Protection Agency
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
LC50 Median lethal concentration - a statistically derived
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.
LD50 Median lethal dose - a statistically derived single dose
than can be expected to cause death in 50% of the test
animals, when administered by the route indicated
(oral, dermal, inhalation). It is expressed as a
weight of substance per unit weight of animal, e.g.,
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
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PADI Provisional Acceptable Daily Intake
ppm parts per million
RfD Reference Dose
TMRC Theoretical Maximal Residue Contribution
11
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TABLE OF CONTENTS
I. Introduction 1
II. Chemical(s) Covered by this Standard 3
A. Description of Chemical
B. Use Profile
C. History
III. Agency Assessment 5
A. Status of the Data Base
B. Toxicological Assessment
C. Other Science Findings
D. Tolerance Reassessment
IV. Regulatory Position and Rationale 21
A. Regulatory Positions
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard 30
VI. Requirement for Submittal of Generic Data 33
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 . . 39
VIII. Requirement for Submittal of Revised Labeling 40
IX. Instructions for Submittal 40
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
111
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APPENDICES
I. DATA APPENDICES 45
Guide to Tables
Table A
Table B
Table C
II. LABELING APPENDICES 107
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 134
Guide to Bibliography
Bibliography
IV. FORMS APPENDICES 151
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
IV
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I.INTRODUCTION
This document is a revised Registration Standard for the
subject chemical. In its original Standard, issued on March 1982
the Agency summarized the available data supporting the
registration of the pesticide and its assessment of those data to
determine whether the pesticide met the "no unreasonable adverse
effects" standard of FIFRA. The Agency concluded that additional
data were necessary to fully evaluate the pesticide, and, as part
of the issuance of the Standard, required that registrants supply
those data. The Standard also set out labeling requirements that
the Agency believed were necessary to ensure that products
containing the pesticide were adequate to protect public health
and the environment while the data were under development.
The Agency has since reviewed the additional data and has
updated and revised its scientific and regulatory conclusions
concerning the pesticide in light of expanded data requirements
promulgated in 1984 as 40 CFR Part 158. The Registration
Standard contains the Agency's updated scientific assessment of
this pesticide and its currently registered uses. As part of its
review, the Agency has reassessed the tolerances for the
pesticide and determined whether they are adequate. The
tolerance reassessment is included in this Registration Standard.
Based, on the new data, the Agency has also reviewed the
labeling requirements for the pesticide and is requiring label
revisions.
This revised Registration Standard supersedes the original
Registration Standard in its entirety.
This document contains the following sections:
0 Section II describes the particular pesticide(s)
covered by this Registration Standard, and gives a brief
profile of its usage and composition. Regulatory
history may be provided as well.
0 Section III sets out the Agency's scientific
assessment of the health risks and environmental
characteristics and effects of the chemical, updated
based on data submitted to the Agency under the original
Registration Standard.
1The scientific reviews and Compendium of Acceptable Uses 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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0 Section IV explains the regulatory decisions and
conclusions arising from the Agency's assessment, and
the rationales for its decisions. Section IV also
describes the labeling statements required for products
containing the chemical. These are divided into
statements for manufacturing use products and statements
for end use products.
0 Sections V, VI, VII, VIII and IX describe what
products are subject to the data and labeling
requirements set out in this Registration Standard, and
what is required of registrants to comply with the
requirements.
0 Appendix I contains a series of tables setting out
data requirements for the chemical. The tables identify
which requirements have been satisfied, as well as those
for which gaps remain. A Guide to Tables introduces the
tables.
0 Appendix II is a series of labeling information
sheets, setting out general labeling information that
must be placed on labeling.
0 Appendix III is a bibliography of the data evaluated
by the Agency in its assessment. A Guide to
Bibliography explains how to read and use the
Bibliography.
Registrants are reminded that FIFRA sec. 6(a)(2)
requires them to submit factual information concerning
possible unreasonable adverse effects of a pesticide at any
time that they become aware of such information. Registrants
must notify the Agency of any information, including interim
or preliminary results of studies, if that information
suggests possible adverse effects on man or the environment.
This requirement is independent of the specific time
requirements imposed by EPA for 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. CHEMICALS COVERED BY THIS STANDARD
A. Description of the Chemicals
This Standard covers 2-methyl-4-chlorophenoxyacetic acid
(MCPA), and its sodium salt, esters and organic amines.
Most often, the acid is formulated into the end-use product
(EP). However, an EP may be in the form of a sodium salt, an
ester, or organic amine. With these formulations, the esters or
amines may greatly influence the physical characteristics,
biological activity and environmental fate of the chemical.
Therefore, the data requirements in this Standard, address not
only the acid and it inorganic salts but also the amine salts and
esters.
Trade Names; Acme MCPA Amine 4, Agritox, Agro one,
Bordermaster, BH MCPA, Chiptox, Ded-Weed, Empal, Kilsem,
Mephanac, Methoxone, Phomene, Rhonox, and Weedar.
Physical Characteristics: The following codes are depicted
below for the acid, salts, and esters of MCPA presented in order
of the Shaughnessy Numbers. The abbreviations used are: EF -
Empirical Formula; MW - Molecular Weight; CAS - Chemical
Abstracts Service Registry Number; SN - Shaughnessy Number.
MCPA Acid
Sodium Salt
Diethanolamine Salt
Dimethvlamine Salt
Butoxvethvl Ester
Butvl Ester
EF: C9H9C1O3
MW: 200.6
CAS: 94-74-6
SN: 030501
EF: C9H8ClNa03
MW: 222.6
SN: 030502
EF: C11H16C1N04
MW: 261.5
SN: 030511
EF: C15H16C103
MW: 245.7
SN: 030516
EF: C15H2iC104
MW: 300.8
SN: 030553
EF: C13H17C1O3
MW: 256.5
SN: 030556
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Isobutyl Ester EF: C13H17C1O3
MW: 256.5
SN: 030562
Isooctyl Ester EF: Ciyl^sClC^
MW: 312.8
CAS: 26544-20-7
SN: 030563
Isopropyl Ester EF: C12H15C1°3
MW: 242.5
SN: 030566
The following are the physical and chemical characteristics
of purified MCPA:
Color: White to light brown
Physical State: Can be solid, flakes, crystal powder, or
liquid
Odor: None to slight phenolic odor
Melting Point: 114 to 119° C
Boiling Point: 350° F
Specific Gravity: 1.06
Solubility (g/100 g solvent at 20° C):
0.03 water
50.2 ethyl ether
5.5 chloroform
91.8 acetone
3.3 benzene
B. Use Profile
Type of Pesticide: Herbicide; Plant Growth Regulator.
Pests Controlled: Broadleaf weeds; grasses and other
monocots; woody plants; aquatic weeds; and nonflowering plants.
Registered Uses: Terrestrial, food and nonfood; aquatic,
food; domestic; and forestry.
Predominant Uses: Postemergent weed control in small grains
(wheat, oats, barley, rye), rice, home lawns, ornamental turf,
and peas. Other registered use sites with lesser usage include
flax, grass seed crops, noncrop areas, pasture grasses, rangeland
grasses, grain sorghum, alfalfa, clovers, beans and noncrop
areas.
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Mode of Activity: MCPA is absorbed through both leaves and
roots and is readily translocated throughout the plant. MCPA
stimulates nucleic acid and protein synthesis affecting the
activity of enzymes, respiration and cell division. Broadleaf
plants exhibit malformed leaves, stems and roots.
Formulation Types Registered: Granular (MCPA acid and
isooctyl ester); Soluble concentrate/liquid (sodium salt,
diethanolamine, dimethyl salt, dimethylamine salt); Technical
(MCPA acid, Butoxyethyl ester, isooctyl ester); Formulation
Intermediate (Butyl ester, isobutyl ester," isopropyl ester,
dimethylamine salt, MCPA acid); Ready-To-Use (Dimethylamine
salt); and Emulsifiable Concentrate (Butoxyethyl ester, isooctyl
ester). There are 117 federally registered products containing
MCPA as an active ingredient either by itself or in combination
with other pesticides.
Methods of Application: Aerial and ground equipment,
knapsack sprayers, pressure and hose-end applicators, and lawn
spreaders.
C. History
MCPA was first registered for pesticidal use in the United
States in 1973. MCPA has uses similar to 2,4-D. It is
apparently the major chemical used in Europe as a postemergent
broadleaf herbicide, whereas in the U.S., 2,4-D is the
predominant herbicide. The major technical producers of MCPA
are: Dow Chemical Company in the U.S. and Kemisk Vaerk Koge in
Denmark. The major formulators are Vertak, Rhone-Poulenc, and
the Platte Chemical Company.
The Agency issued a Registration Standard on MCPA and its
salts and esters in 1982. In that document, the Agency
considered MCPA and the sodium salt as one entity for most
categories of testing. Registrants of products containing esters
and amines of MCPA acid had the option of providing all data on
each ester or amine derivative or of citing data showing that a
particular amine or ester would be equivalent to MCPA acid under
test conditions. Discussions did take place between registrants
and EPA on this matter. However, no definitive decisions were
made by EPA and this equivalency issue is unresolved. The
Agency is now assessing all data available concerning MCPA.
III. AGENCY ASSESSMENT
A. STATUS OF THE DATA BASE
Toxicology. The 1982 MCPA Registration Standard required a
full battery of toxicologic testing on MCPA acid, each salt
and ester. The Registrants were given the opportunity to
submit evidence which substantiated that a particular salt or
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ester derivative would be toxicologically equivalent to the
MCPA acid. The Agency also identified conflicting studies
on the teratogenic, fetotoxic, mutagenic, and spennatogenic
potential for MCPA.
From data submitted since the issuance of the 1982
standard, the Agency has determined that MCPA does not have
fetotoxic and spermatogenic potential. A gene mutation study
is still required. (Structural Chromosomal and DNA Damage
and Repair studies were negative). Teratogenicity testing is
still required (the unacceptable studies showed no evidence
of compound related effects). Special neurotoxicity testing
is now required because of MCPA's structural similarity to
2,4-D (2,4-D is suspected of causing neuropathy in humans).
The issue of the equivalency of the acid, salts, and esters
still remains and if it cannot be shown, the Agency is
requiring a full battery of toxicology testing on all the
derivatives.
Environmental Fate. There is insufficient information to
fully assess the environmental fate of MCPA acid and its
derivatives. As stated above, registrants were given the
opportunity to show that MCPA acid would satisfy the data
requirements for the derivatives, but no data has been
submitted. On rereview of studies used for the 1982
assessment, the hydrolysis, photolysis, leaching, and aquatic
field dissipation studies are now unacceptable and new
studies must be submitted.
Ecological Effects. The 1982 standard required a full
battery of fish and wildlife testing on MCPA acid and its
derivatives. The ecological effects data base is fairly
complete for the acid and sodium salt derivative (an avian
reproduction, a shrimp LC50, an aquatic organism
accumulation, and nontarget plant phytotoxicity studies are
required). Extensive data requirements remain for the amine
salts and ester derivatives.
Residue Chemistry. Only plant metabolism data were required
to support the established tolerances for residues in or on
plant or animal commodities in the 1982 document. As a
result of the new residue chemistry guidelines and other
policy changes since issuance of the first standard, the
Agency is now requiring additional data on the identity and
quantities of residue on plants and animals. Storage
stability data not required in 1982 are now required.
Further data on the magnitude and levels of residues in raw
agricultural commodities, animal products, and processed food
and feed items are required. Data are not adequate to
support all of the established tolerances.
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B. TOXICOLOGICAL ASSESSMENT
This section discusses acceptable toxicological data
available to the Agency for MCPA. From a toxicological
standpoint, the acid and sodium salt are considered
equivalent. The toxicology of MCPA acid is presented first,
with the limited acute data for the esters and amine salts
presented separately.
The 1982 MCPA registration standard required a full
battery of toxicological testing on MCPA acid, each salt and
each ester. Alternatively, registrants could submit evidence
which substantiated that a particular salt or ester would be
toxicologically equivalent to MCPA acid. The issue of MCPA
acid data supporting the data requirements for the various
derivatives has not been resolved. The 1982 standard also
identified conflicting studies on the teratogenic, fetotoxic,
mutagenic, and spermatogenic potential,of MCPA. These
conflicts prevented the Agency from making a toxicologic
assessment of MCPA at that time. Since the issuance of the
1982 standard, toxicology data has been submitted by
registrants and reviewed by the Agency to eliminate many of
these conflicts. The following is the Agency's
toxicological assessment.
Acute Toxicity Data
Acute Oral. Data are available to show that technical
grade MCPA acid is of moderate acute toxicity to rats. The
acute oral LDsg for rats is 1.383 g/kg in male rats and 0.765
g/kg in female rats; Toxicity Category III. No additional
acute oral studies are required for MCPA acid.
Acute Dermal. Data are available to show that technical
MCPA acid is of low acute dermal toxicity to rabbits. In a
14-day repeated dose dermal toxicity study, no mortality was
observed at doses of 2000 or 4000 mg/kg. Therefore, the
for MCPA is set at > 4000 mg/kg (male and female rats);
Toxicity Category III. No additional acute dermal studies
are required for MCPA acid.
Acute Inhalation. Data are available to show that
technical MCPA acid is moderately acutely toxic via
inhalation to rats. The acute inhalation LC50 (4-hour
exposure) is > 6.36 mg/L; Toxicity Category III. No
additional acute inhalation studies are required for MCPA
acid.
Primary Eye Irritation. Technical MCPA acid has been
placed in Toxicity Category I for primary eye irritation
based on the observation of corneal opacity with irritation
of conjunctivae observed in one of 6 rabbits 21 days post-
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instillation for a soluble concentrate formulation. No
additional primary eye irritation studies are required for
MCPA acid.
Primary Skin Irritation. No primary skin irritation
study is available on technical MCPA acid. A study is
required.
Dermal Sensitization. Data are available to show that
technical MCPA acid is not a dermal sensitizer in guinea
pigs. However, other supplementary testing exhibited some
skin erythema or irritation. Additional testing is required.
Acute Delayed Neurotoxicity. No acute delayed
neurotoxicity study is available on MCPA. since MCPA is not
an organophosphate, nor is it reported to produce acetyl
cholinesterase inhibition, a study is not required.
Subchronic Oral
Sufficient data are available to satisfy the
requirements for a subchronic oral study in rodents and
nonrodents.
Oral administration of MCPA (technical, purified) to
male and female beagles (0, 3, 12, and 48 mg/kg/day) and a
repeat study (0, 0.3, 1, and 12 mg/kg/day) for 13 weeks
resulted in severe toxicity and mortality at the HDT (48
mg/kg/day). There was evidence of dose-related liver and
kidney toxicity (changes in serum enzymes, decreased ability
to filter dyes). These effects were found in both sexes at
dose levels down to 3 mg/kg/day and were associated with
kidney and liver histopathology changes (pyelitis, bile duct
proliferation, bile pigment, etc.) in the 48 and 12 mg/kg/day
dose groups. Based upon these findings, the NOEL for
systemic effects is set at 1 mg/kg/day.
MCPA technical was fed to male and female rats for 3
months at dose levels of 0, 2.5, 7.5, and 22.5 mg/kg/day.
The kidney was the major target organ based upon increased
absolute and relative kidney weights in mid- and high-dose
males, but not females. This was associated with a
significant decrease in serum calcium in HDT males and a
significant elevation in creatinine concentrations in HDT
females. Both sexes had apparent crystalluria (oxalate,
calcium phosphate, urate) in the high-dose groups, another
possible indicator of kidney dysfunction. These findings in
the kidney were not confirmed from histopathological
evaluation, therefore the toxicological nature of MCPA on
kidneys is unknown. Hepatotoxicity is also suggested in HDT
males based upon prolongation in clotting times and
decreased cholesterol concentrations. Based upon significant
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elevations in kidney weights (absolute, relative) at both the
mid- and high-dose levels in male rats, the NOEL for systemic
effects is set at 2.5 mg/kg/day.
No additional subchronic oral studies are required.
Subchronic Dermal (21-Davy
Sufficient data are not available for technical MCPA
acid to fulfill the requirement for a 21-day dermal study.
Since the existing acceptable uses of MCPA could result in
repeated human skin contact of a limited frequency and
duration, a study is required. However, since the existing
acceptable uses of MCPA should not result in purposeful or
prolonged exposure of the human skin, a 90-day dermal study
is not required.
Subchronic Inhalation (90-Day)
A 90-day inhalation study for MCPA acid is not
available. Since the existing acceptable end-uses (presently
registered uses) should not result in repeated inhalation for
extended periods, a subchronic inhalation study is not
required.
Subchronic Neurotoxicity
A subchronic neurotoxicity test is not required since
MCPA is not an organophosphate compound.
Chronic Toxicity
Sufficient data are available to satisfy the
requirements for the chronic feeding studies in both species
for technical MCPA acid. No further chronic toxicity data
are needed for MCPA acid.
The oral administration of technical MCPA to male and
female beagles at doses of 0, 0.15, 0.75, and 3.75 mg/kg for
a period of 52 weeks resulted in kidney and liver toxicity at
the mid- and/or high-dose levels with alterations in clinical
chemistry or enzymes associated with concomitant organ weight
changes (liver) and histopathology changes (kidney: proximal
tubular epithelium; liver: - change in nature of gall fluid).
Therefore, based upon kidney and liver toxicity of a moderate
nature at the 0.75 and 3.75 mg/kg dose levels, the systemic
toxicity NOEL is set at 0.15 mg/kg/day, LDT.
Oral administration of MCPA (0, 1.0, 4.0, and 16.0
mg/kg/day) for two years in the diet of male and female
Wister rats produced evidence of body weight depressions in
males but not females; and hepato- and nephrotoxicity in both
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sexes at either the mid or high dose level. Hepatotoxicity
was evident primarily in females; statistically significant
elevations in triglycerides (mid dose tested (MDT) , highest
dose tested (HOT)) in both sexes, decreased cholesterol and
increased clotting time in HOT females and increased SGPT
levels (MDT/HDT) in females were observed. Nephrotoxicity
was indicated by increased absolute and relative kidney
weights in HOT females associated with an elevation in blood
urea concentrations. In HDT males, gross pathology in the
kidney was suggested by an increase in retraction and
granularity of the kidneys associated with an increase in
chronic progressive nephropathy. There was no evidence of an
oncogenic response in either male or female rats treated with
MCPA under the conditions of the bioassay. The systemic
toxicity NOEL is set at the low dose level (1.0 mg/kg/day)
for both males and females based upon the hepatotoxicity and
nephrotoxicity observed in either the mid and/or high dose
groups .
Oncogenicity
There are adequate studies available to satisfy the data
requirements for oncogenicity studies in two species (rat,
mouse) .
The rat chronic toxicity study discussed above fulfills
the requirement for the rat oncogenicity study. As stated
above, there was no evidence of an oncogenic response in
either male or female rats at the dose levels tested (1,4,16
An acceptable 2 year oncogenicity study with B6C3F1 mice
at dietary levels of 0, 3, 15, and 75 mg/kg/day was reviewed.
MCPA is considered to be non-oncogenic under the conditions
of the study.
Teratoqenicity
Studies cited as acceptable in the original 1982
Registration Standard were found unacceptable upon rereview.
In the rat teratology study cited in 1982, there was
generally no evidence of compound related effects upon
maternal or fetal health or development. However, due to
technical deficiencies in the study, a developmental NOEL
cannot be determined. In a rabbit teratology study relied on
in 1982, increased maternal deaths at the HDT of 75 mg/kg
associated with 100% resorptions were observed. There were
no developmental alterations. Again, technical deficiencies
in the study prevent determination of a developmental NOEL.
Teratology studies in two species are required.
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Reproduction
There are sufficient data available to satisfy the data
requirement for a reproductive study for technical MCPA.
In a two-generation reproduction study, MCPA was
administered in the diets of adult rats at 0, 2.5, 7.5, and
22.5 mg/kg/day continuously from study initiation (at least
10 weeks prior to mating, throughout mating, gestation and
lactation). Some consistent but slight depressions in pup
body weight or body weight gains were observed at day 14 or
day 21 in the high-dose group males and/or females of all
littering groups (Fla, Fib, F2a, F2b). This is believed to
be a result of direct toxicity of MCPA and not necessarily a
reproductive effect, since the toxicity is not seen until
later in the weaning period when the pups are being exposed
to both the mothers' milk and dietary mix with MCPA also.
However, a possible delayed postnatal growth effect cannot be
ruled out.
Based upon the small but statistically significant
depression in male and/or female pup weights/pup weight gains
by days 14 and 21 of weaning in all littering groups (Fla,
Fib, F2a, F2b), which may indicate a potential delayed
postnatal growth effect, the NOEL is set at the mid-dose
level of 7.5 mg/kg/day.
An additional reproduction study is not required.
Mutaaenicitv
There are sufficient data available to satisfy the
mutagenicity requirements for structural chromosome
aberrations and DNA damage and repair.
Gene Mutation. No acceptable study is available.
A gene mutation study is required.
Structural Chromosomal Aberrations. After
administration of single oral doses of 33, 200, and 1200
mg/kg MCPA to male and female Chinese hamsters, it was
concluded that MCPA was not mutagenic in bone marrow cells
(metaphase analysis) examined at 6, 24, and 48 hours post-
administration. No additional structural chromosomal
aberration studies on MCPA acid are required.
Other Genotoxicity; DNA Damage and Repair. After a
single oral dose of MCPA at 1200 mg/kg to male and female
Chinese hamsters, the test compound produced a statistically
significant elevation (1.5 fold) in the number of sister
chromatid exchanges (SCE) in bone marrow cells. It was
concluded that MCPA was weakly mutagenic in this bioassay.
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No additional genotoxicity studies on MCPA acid are required.
Metabolism
Sufficient data are available to meet the data
requirements for a metabolism study with technical MCPA.
After a single oral dose (100 mg/kg) of 14C-MCPA, the
test material is excreted in the urine of male and female
rats by 24 and 48 hours. Approximately 100 percent of the
dose in either male or female rats (85.9% and 70.3%
respectively) is absorbed after oral administration based
upon radioactive recoveries at 192 hours (101.3 and 92.5%,
respectively). MCPA does not appear to be significantly
metabolized in vivo since it is the major component recovered
in male and female rat urine (82 and 88%, respectively).
Major organ/tissue sites are the plasma, liver, kidney,
thyroid and stomach; fat and skin appear to sequester
radiolabeled MCPA to a limited extent. Repeat dosing
(1 mg/kg up to 14 days; once/day did not generally indicate
bioaccumulation in any site except perhaps the kidney,
primarily in males. As in the single dosing study, fat
appeared to be the site of some MCPA sequestration.
An additional metabolism study is not required.
Special Neurotoxicity Testing
MCPA is structurally related to 2,4-D which is suspected
of causing neuropathy in humans. Special neurotoxicity
testing of 2,4-D is currently required. Because of this
structural similarity to 2,4-D, the Agency is also requiring
neurotoxicity testing of MCPA acid and its derivatives.
Toxicology Profile of Other MCPA Derivatives
The Agency has registered 12 salts, esters and amines of
MCPA in addition to the acid. As stated previously, from a
toxicological standpoint one may expect the acid and the
sodium salt to be essentially identical. However, the
remaining organic amines and esters may be significantly
different and, lacking data to show otherwise, may be
expected to have different qualitative and/or quantitative
toxicological properties. The major exposure to these
compounds is during application. Additional toxicology data
are required on the organic amines and esters of MCPA (see
Toxicology Data Tables Appendix I). The following is a
listing of acceptable acute toxicity data avaiable for some
of the derivatives:
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Compound
Findings
Acute Oral
MCPA butoxyethyl ester
(95.5% purity)
Acute Dermal
MCPA butoxyethyl ester
(95.5% purity)
LD50 is 1000 mg/kg in
male rats and 785
mg/kg in female rats;_
acceptable data;
Toxicity Category
III
LD50 = 2828 mg/kg
(male rabbits);
acceptable data;
Toxicitv Category III
Acute Inhalation
MCPA butoxyethyl ester
(95.5% purity)
MCPA isooctyl ester
(purity 95.1%)
> 4.2 mg/L/4 hours
(rats, both sexes;
acceptable data;
Toxicity Category III
LC5Q > 4.4 mg/L/4 hours
(rats, both sexes);
acceptable data;
Toxicitv Category III
Primary Eye Irritation
MCPA butoxyethyl ester
(95.5% purity)
No eye irritation
observed beyond 48 hours
postinstillation (female
rabbits); acceptable
data; Toxicity Category
III
Primary Skin Irritation
MCPA butoxyethyl ester
(95.5% purity)
Little evidence of skin
irritation (male, female
rabbits); acceptable
data; Toxicity Category
IY
Dermal Sensitization
MCPA butoxyethyl ester
(95.5% purity)
Not a potential skin
sensitizer (male guinea
pigs); acceptable data
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Isooctyl ester of MCPA
(48.6% MCPA acid equivalent)
MCPA dimethylamine salt
(43.3% MCPA acid equivalent)
C. HUMAN EXPOSURE
May be a potential skin
sensitizer (male guinea
pigs); acceptable data
Not a skin sensitizer
(male guinea pigs);
acceptable data
The high volatility of MCPA esters increases the potential
of respiratory exposure. Most salt formulations are essentially
non-volatile. Spray drift, primarily from aerial spraying
operations using ester formulations may lead to exposure of
humans, livestock, wildlife, and crops outside of the
application site. Most direct human exposure will be during
mixing and loading operations. Exposure should be minimized by
the wearing of appropriate protective equipment. From results of
acute studies, the Agency has identified that protective eyewear
is appropriate for mixers/loaders/applicators using the MCPA acid
products. Use of protective eyewear is also required on
homeowner use products that contain MCPA acid. No specialized
protective language, other than those stated in 40 CFR 156 is
warranted for other MCPA derivative homeowner use products.
Poisoning Incidents
The Pesticide Incident Monitoring System (PIMS) report does
not contain any cases of hospitalization, or deaths in California
or the nation. There have been no poisoning incidents with MCPA
reported in California since 1974.
Reentry and Sprav Drift
Based on available toxicology data, MCPA end-use products
are of low acute toxicity, generally falling in Toxicity Category
III. Therefore, reentry data are not required since MCPA does
not meet the criteria for reentry data requirements given in 40
CFR 158.390 or spray drift data requirements given in 40 CFR
158.440.
D. OTHER SCIENCE FINDINGS
1. ENVIRONMENTAL FATE
Available data are insufficient to fully assess the environ-
mental fate of MCPA and its various derivatives. An ester or
amine derivative may behave differently in the environment than
the MCPA acid. Data required on each derivative are indicated in
the Environmental Fate data tables (see Appendix I). Data on
MCPA acid will satisfy the data requirements for the MCPA sodium
salt. Data on MCPA acid will be applicable to the amine salts
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and ester derivatives only if the registrants can show that the
parent chemical dissociates or degrades from the salt or ester
derivative to MCPA acid. Information on the rate and
completeness of the dissociation or degradation reaction to the
acid are essential to the development of an environmental fate
profile for each registered MCPA chemical derivative.
A large number of studies were reviewed in the original MCPA
Registration Standard, the majority of which were previously
judged to be unacceptable. The 1982 document required studies on
physical and chemical degradation, metabolism, field dissipation,
and accumulation. In four study categories the Agency is now
requiring more data than in the Registration Standard of 1982.
- The hydrolysis study requirement was previously judged to
be partially fulfilled and is currently judged to be unacceptable
because of study deficiencies including the fact that the test
duration was only 13 days.
- The photolysis study requirement was previously listed as
partially fulfilled in the original Registration Standard.
However, this was not accurate because the study was not
acceptable and all data were required.
- The leaching study requirement was fulfilled previously and
is currently considered to be partially fulfilled. Additional
studies are needed in addition to the previously submitted thin-
layer chromatography (TLC) study to assess leaching potential.
Furthermore, the adsorption/desorption category, which was listed
in 1982 as a separate category, is currently grouped in the
leaching and adsorption/desorption category.
- The aquatic field dissipation requirement was previously
considered to be partially fulfilled, however that study would
not currently be regarded as an aquatic field dissipation study
and therefore is not acceptable.
Preliminary data have shown MCPA to degrade under laboratory
aerobic conditions with a half-life ranging from less than a week
to greater than 50 days. Two degradates included 4-chloro-o-
cresol and 5-chloro-3-methylcatechol. Acceptable data on
anaerobic aquatic metabolism demonstrated that 89 percent of the
parent MCPA remained undegraded at 374 days. Preliminary data
indicate that MCPA is stable to hydrolysis and to photolysis on
soil. MCPA was found to be mobile as determined by soil TLC (Rf
0.6 to 1.0) in sandy loam, silt loam and silty clay loam, soils.
The data are insufficient to fully assess leaching potential.
Preliminary field dissipation data indicate dissipation
within the range found in the laboratory aerobic metabolism
studies. Preliminary field aquatic dissipation data indicate
that MCPA dissipates rapidly (14 to 21 days) in water, but
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persists unchanged in the flooded soil. No laboratory anaerobic
soil metabolism data is available to help confirm these results.
Preliminary forestry data indicate that MCPA is persistent in
soil and leaf litter at 10 months posttreatment.
MCPA salts are highly soluble in water. The salts are
considered to be somewhat less phytotoxic to crops than are the
esters; however the esters are somewhat more effective on some
perennial and woody weeds. The salts are less volatile than the
esters.
Groundwater
MCPA appears to be mobile and was detected at a level ranging
from 0.36 to 5.5 parts per billion (ppb) in 3 of 13 wells that
were tested for multiple chemicals in Missouri. Groundwater
contamination appears to be associated with point sources (mixing
and loading sites). No special groundwater data, beyond that
required in 40 CFR 158.290, are required at this time. Because
of the above information and the chemical structure of MCPA, a
special groundwater statement is being required (see Labeling
Requirements section IV.D. in this document).
2. ECOLOGICAL EFFECTS
Available data are insufficient to completely evaluate the
ecological effects of MCPA. The 1982 MCPA Registration Standard
required a full battery of fish and wildlife testing on MCPA
acid. In addition certain data were required on the derivatives
of MCPA. Data, as set forth in the data tables (refer to
Appendix I), are either required or reserved pending evaluation
of required data. From an ecological effects standpoint, MCPA
acid and the sodium salt are essentially equivalent. Therefore,
ecological effects data available for the acid will support the
sodium salt. Data on the MCPA acid will not support the data
requirements for the ester or amine derivatives. The following
conclusions can be made based on data available to the Agency:
Effects on Birds - Avian toxicity data are complete for MCPA
acid. Data are required for all other MCPA derivatives.
Studies on MCPA acid indicate an acute oral LD50 value of 377
mg/kg for bobwhite quail and dietary LC50 values of > 2000 ppm
for the mallard, bobwhite, and ring-necked pheasant. These data
incidate that MCPA acid is moderately toxic to avian species on
an acute basis and practically nontoxic on a subacute dietary
basis. These data are applicable to the sodium salt and fulfill
the data requirements for these studies for both the technical
acid and the sodium salt.
Effects on Fish Freshwater Fish - Ecotoxicity studies
indicate that MCPA acid is slightly toxic to freshwater fish on
an acute basis (rainbow trout LC50 =* 89 ppm, bluegill sunfish
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LC5n = 97 PPm)• Toxicity studies on the sodium salt derivative
indicate that this compound is practically nontoxic to fish
(LC50 values > 180 ppm). These studies fulfill the warmwater and
coldwater fish LCso study requirements of the sodium salt
formulations. A rainbow trout study on the dimethylamine salt
derivative indicates that this compound is practically nontoxic
to coldwater fish species (LC50 = 117 ppm). This study fulfills
the coldwater fish LC50 requirement of the technical
dimethylamine salt. Additional data on the various MCPA
derivatives are required.
Effects on Freshwater Invertebrates - A study on daphnids
using MCPA acid showed practically no toxicity to aquatic
freshwater invertebrates (LC50 > 180 ppm). Acute LC50 testing on
freshwater aquatic invertebrates is required for the various
MCPA derivatives. In addition, product testing using the sodium
salt is required to support the registered aquatic use.
Effects on Estuarine and Marine Organisms - Toxicity studies
indicate that MCPA acid is practically nontoxic to estuarine and
marine organisms (Atlantic Silverside LC50 = 179 ppm; Oyster
larvae LCso = 155 ppm). Additional testing is required in shrimp
for the acid of MCPA. A complete battery of tests are required
for the various MCPA derivatives. Formulated product testing
using the sodium salt is required to support the registered
aquatic use.
Effects on Plants - All MCPA derivatives are labeled to
control a variety of broadleaf weeds. MCPA salts are highly
soluble in water. The salts are considered to be somewhat less
phytotoxic to crops than are the esters; however the esters are
somewhat more effective on some perennial and woody weeds. The
salts are less volatile than the esters.
The Agency has no acceptable data for toxicity of nontarget
plants. A complete battery of tests are required for MCPA acid
and each derivative.
Risk to Nontarget Organisms (Including Endangered Species) -
Due to limited environmental fate and ecological effects data,
complete hazard assessments cannot be conducted at this time.
Because of MCPA's demonstrated toxicity to nontarget species
and its intended use pattern, this pesticide has been identified
by the Office of Endangered Species (OES), U.S. Fish and Wildlife
Service (USFWS), as being likely to jeopardize the continued
existence of certain endangered species when used on range,
pastureland, corn, wheat, sorghum, oats, barley, and/or rye.
Based on this determination, OES specified reasonable and prudent
alternatives to avoid jeopardizing the continued existence of the
identified species by these uses. EPA is working with the FWS
and other Federal and State agencies to implement the alterna-
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tives in a technically sound matter. The Agency has initiated a
comprehensive plan for protecting endangered species. This
program was announced in the Federal Register Vol. 54(126) on
Monday, July 3, 1989. The program includes a new approach to
biological consultation and a revised implementation plan,
including a voluntary Interim Program. Registrants are to refer
to the Federal Register notice for greater details.
Nontarget Insects - There is sufficient information to
characterize MCPA acid and its sodium salt derivative as
relatively nontoxic to honey bees, when bees are exposed to
direct treatment. Bee toxicity data are not required for the
butyl ester, isobutyl ester and isopropyl ester because there are
no registered outdoor uses; for the diethanolamine salt and
butoxyethyl ester there is low potential for bee exposure and no
data are required; there is significant potential for bee
exposure to the dimethylamine salt and isooctyl ester and data
are required for these last two derivatives.
3. PRODUCT CHEMISTRY
The data tables in Appendix I go into greater detail for
specific data requirements. The Agency has determined that
product chemistry data for all technical and manufacturing-use
products must be resubmitted for each pesticide because new
requirements have been introduced since the issuance of the
Registration Standard in 1982. Up until 1982, no registrant of a
product containing MCPA or an MCPA derivative had submitted a
detailed manufacturing process, a discussion of the formation of
unintentional substances in the product, a declaration and
certification of ingredient limits, or analytical data on the
product. For many products, a confidential statement of formula
had not been submitted, was outdated, incomplete or in error.
Data on numerous physical and chemical properties had not been
submitted. The Agency is now requiring that previously submitted
data be updated.
The Agency has noted, as it did in the 1982 document, that
MCPA may be contaminated with dioxins or dibenzofurans, and that
the amine salts of MCPA may be contaminated with n-nitrosamines.
Analytical data to identify and quantify these contaminants are
required for certain products (refer to Product Chemistry Data
Requirement Tables in Appendix I) .
E. TnT.-BFAtJCE ASSESSMENT
Only plant metabolism data were required to support the
established tolerances for residues in or on plant or animal
commodities in the Registration Standard issued in March 1982.
However, additional data gaps have been identified as a result
of residue chemistry guidelines issued in 1982 and other policy
changes since that time.
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Tolerances for residues in or on food and feed plant
commodities are currently expressed in terms of MCPA per se (40
CFR 180.339(a)) and tolerances for residues in or on animal
commodities are expressed in terms of combined negligible
residues of MCPA and its metabolite 2-methyl-chlorophenoxyacetic
acid (40 CFR 180.339(b)). EPA has evaluated the residue and
toxicology data supporting these tolerances. The following were
considered during this evaluation:
o Whether the current tolerances and food additive
regulations are sufficient to cover the actual residues
resulting from use (including FIFRA section 24(c)
registrations).
o Whether group tolerances can be established in accordance
with 40 CFR 180.34(f).
o Whether, in the absence of tolerances, restrictions on
use, grazing, or feeding of treated commodities are
necessary.
o Whether the tolerances are expressed accurately and in
current terminology.
The Agency's findings as a result of this evaluation are
summarized below. The regulatory results of the Agency's review
are set out in Section IV, Regulatory Position and Rationale.
Residue Data
The residue data reviewed in support of these tolerances
showed the following:
1. Data on the metabolism of MCPA in plants available for
review in the 1982 document indicated that MCPA is readily taken
up and translocated by plants. Additional data are required on
the identity and quantities of residue in or on plants. The
nature of the residue is not adequately understood.
2. Data pertaining to the residues of MCPA in animals were
reviewed for the 1982 document. That document did not require
additional data on animal metabolism. Current Guidelines specify
that terminal residues in animals be identified and quantified
using radioactive material. The metabolism of MCPA in animals is
not adequately understood and additional data are required.
3. The current residue analytical methods in PAM I are
adequate for enforcement of tolerances for residues in plants and
animals.
4. Data depicting the stability of MCPA residues in storage
were not required in the 1982 document. Current Guidelines
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specify that storage stability data must be submitted in support
of established tolerances.
5. There are available data to support the established
tolerances for MCPA in or on canarygrass seed and straw.
6. Additional residue data are required on dried beans,
peas (succulent and dry), pea vines and hay, rice grain, sorghum
grain, wheat grain, rice straw, sorghum forage and fodder, wheat
straw, annual canarygrass, pasture and rangeland grasses, grass
hay, alfalfa and alfalfa hay, flaxseed, and flax straw.
7. The data requested on wheat grain, forage, and straw may,
by translation, support the established tolerances for residues
of MCPA in or on the grain, forage, and straw of barley, oats,
and rye. The data requested on alfalfa and alfalfa hay may, by
translation, support the established tolerances for residues of
MCPA in or on clover and clover hay, lespedeza and lespedeza hay,
trefoil and trefoil hay, and vetch and vetch hay.
8. Processing data are needed on rice grain, sorghum grain,
wheat grain, and flaxseed. The requirements for processing data
on barley, oat, and rye grain may be satisfied by the data
requested on wheat.
9. Tolerances need to be proposed for residues of MCPA in or
on bean vines and hay, barley hay, oat hay, rye hay, wheat forage
and hay, and canarygrass forage.
10. Upon receipt of the data requested on animal metabolism
and livestock feed items, the established tolerances for the
combined residues of MCPA and 2-methy1-4-chlorophenol in the
meat, fat, and meat by-products of cattle, goats, hogs, horses,
and sheep and in milk will be assessed and the need for
tolerances for residues in poultry tissues and eggs will be
determined.
Toxicology Data
A provisional acceptable daily intake (PADI, RfD) of 0.0015
ing/kg/day for MCPA has been established based on a 1-year feeding
study (dog, NOEL 0.15 mg/kg). The value given is a PADI because
of the teratology data gaps. However, when the teratology
studies are submitted and found acceptable, they are not expected
to greatly alter the RfD calculations. A safety factor of 100
was utilized. The dietary exposure was calculated using the
published tolerances in 40 CFR 180.339. A dietary exposure for
the U.S. population is calculated to be 0.001547 mg/kg/day,
corresponding to 103 percent of the RfD. The population
subgroups with the highest calculated exposure were nonnursing
infants (0.007405 mg/kg/day, 493% of the RfD) and children 1 to 6
years of age (0.004069 mg/kg/day, 271% of the RfD). A dietary
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exposure was also conducted using the published tolerances
factored by the percent of crop treated with MCPA. The dietary
exposure for the U.S. population is then 10% of the RfD, for
nonnursing infants, 51% of the RfD, and for children 1 to 6 years
of age, 27% of the RfD.
IV. REGULATORY POSITION AND RATIONALE
A. Regulatory Positions and Rationales
Based on the review and evaluation of available data on MCPA,
the Agency has made the following determinations. Where label
revisions are imposed, specific language is set forth in the
labeling section of this chapter.
1. The Agency will not place MCPA in Special Review at this
time.
Rationale. Based on the data available to the Agency,
MCPA has not met or exceeded any of the risk criteria specified
in 40 CFR 154.7 to initiate a Special Review. The Agency will
evaluate potential risks as additional data become available and
will consider additional regulatory action, if applicable.
2. The Agency will not restrict the use of MCPA products to
certified applicators.
Rationale. Based on available data, MCPA products have
not met or exceeded any of the criteria specified in 40 CFR
152.170 which would indicate a need to restrict its use.
3. The Agency will require data on the acid, sodium salt,
amines, and esters of MCPA as reflected in the data tables of
this document and as previously required in the 1982 MCPA
Registration Standard.
Rationale. When MCPA 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
MCPA. Data on each salt, ester and amine derivative are needed
to allow evaluation of these forms of MCPA.
4. The Agency is requiring precautionary labeling to
minimize any potential hazard to nontarget organisms.
Rationale. Certain formulations of MCPA are toxic to
fish and/or aquatic invertebrates. Precautionary labeling will
reduce any potential risks to these organisms from the use of
MCPA.
5. The OES in the USFWS has determined the use of MCPA may
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jeopardize the continued existence of endangered species or
critical habitat of certain endangered species. The Agency has
initiated an Endangered Species Protection Program. That
program was announced in the Federal Register of July 3, 1989 (54
FR 27984). No additional labeling is being required at this
time.
Rationale. In May 1987, EPA issued PR Notices 87-4 and
87-5 in response to OES findings that certain pesticides,
including this chemical, jeopardized the continued existence of
endangered species. Those PR Notices directed registrants to add
labeling to their products which referred users to additional
information that, in turn, explained limitations on use of the
pesticide within the range of jeopardized endangered species.
Subsequent to issuance of these PR Notices, EPA identified a
number of significant technical errors and inconsistencies in the
information to which users would have been referred. Therefore,
on January 26, 1988, the Agency issued PR Notice 88-1 which
withdrew PR Notices 87-4 and 87-5 pending development of a more
focused program to protect endangered species.
The proposed comprehensive program includes a new
approach to biological consultation and a revised implementation
plan, including a voluntary Interim Program. Consult the Federal
Register notice for details of the new program. When that
program is fully developed, registrants will be notified of any
labeling statements imposed on MCPA products that the Agency
found necessary to protect endangered species.
6. The Agency is requiring a groundwater warning statement
on the labels of MCPA products.
Rationale. Residues of MCPA have been detected in
groundwater, mostly from point sources, such as mixing, loading
and disposal sites. Since MCPA could be a potential groundwater
contaminant, a label statement will advise users to exercise
caution when handling MCPA products to prevent such contamina-
tion.
The Agency is currently finalizing its Agricultural
Chemicals in Groundwater Strategy and its policy for restricting
the use of pesticide products which may reach groundwater. When
the policies are in place, the Agency will consider what action
is appropriate for MCPA products and other products containing
ingredients which may reach groundwater.
7. The Agency is not requiring a reentry interval for MCPA
products.
Rationale. Based on the toxicological data available to
the Agency, MCPA products have a low acute oral, acute dermal,
and acute inhalation toxicity (Toxicity Categories III and IV).
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Because of these low acute toxicity levels, it is not necessary
to establish a reentry interval.
8. The Agency is requiring protective clothing (eye
protection) labeling for MCPA acid product for mixers, loaders,
and applicators.
Rationale. Based on technical MCPA acid product data,
the MCPA acid is Toxicity Category I for eye irritation. Mixers,
loaders, and applicators are required to wear eye protection
equipment. Homeowner use products containing MCPA acid have
been placed in Toxicity Category I for eye irritation and will
also require the wearing of eye protection equipment.
Registrants must submit acute eye irritation data to support any
request to change this toxicity category for homeowner use
products. Refer to the required labeling section IV C. in this
document and precautionary labeling language found in 40 CFR 156.
9. The Agency will consider establishment of significant
new food use tolerances for MCPA.
Rationale. While the current residue chemistry and
toxicology data are not sufficient to assess all existing
tolerances, the current calculated dietary exposure factored by
the percent of crop treated for nonnursing infants (this group
has the highest potential exposure to MCPA residues) is 51% of
the Rfd. The Agency will consider registering significant new
food/feed uses when data are available to establish a more
complete human dietary exposure data base.
10. The Agency will assess the adequacy of the tolerances
for residues of MCPA in milk, and in meat, fat, and meat
byproducts of cattle, hogs, horses, and sheep upon receipt and
evaluation of required data.
Rationale. Numerous data gaps exist pertaining to the
data requirements on livestock feed items. Further, the
metabolism of MCPA in animals is not adequately understood.
11. The Agency will require that tolerances be proposed for
the raw agricultural commodities bean vines and hay, barley hay,
oat hay, wheat forage and hay, and canarygrass forage OR all
pertinent product labels may be amended to impose a restriction
of the feeding of these commodities to livestock.
Rationale. Tolerances have not been proposed or
established for residues of MCPA that occur from its use on these
commodities.
12. The Agency is deleting the entry in 40 CFR 180.339(a)
of "vegetables, seed and pod." The Registrant must propose
appropriate individual commodity tolerances.
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Rationale. There are insufficient data to support a
group tolerance for vegetables at this time. Since a group
tolerance is not appropriate at this time, the individual
tolerances of the various commodities must be expressed.
13. The Agency is requiring that additional residue data be
submitted for residues of MCPA in or on dried beans, peas
(succulent and dry), soybeans, pea vines and hay, wheat grain,
rice grain, sorghum grain, wheat straw, rice straw, canary grass
forage, pasture grass forage and hay, alfalfa, alfalfa hay, and
flaxseed and flax straw.
Rationale. While data on many of these commodities were
not required in the previous Registration Standard, it is now
determined that the data pertaining to residues of MCPA in or on
these crops were inadequate.
14. The Agency is requiring processing data for rice grain,
sorghum grain, wheat grain, and flaxseed.
Rationale. Data are unavailable to assess whether
additional tolerances are required in the processed commodities
of these crops.
15. The Agency is requiring storage stability data of MCPA
residues.
Rationale. While not required in the 1982 document,
current Guidelines (Subdivision 0) specify that all data
submitted in support of established tolerances must be validated
by adequate storage stability data.
16. The Agency is requiring that the registrant propose a
pertinent product label preharvest interval (PHI) for peas
(succulent and dry), beans (succulent and dry), rice grain,
sorghum grain, wheat grain, rice straw, sorghum forage and
fodder, wheat straw alfalfa, alfalfa hay, clover forage and hay,
flaxseed and flax straw. The Agency is also requiring that the
preslaughter intervals (PSI) be deleted from labels for
pastureland and pasture grass. The Registrant must propose
pregrazing intervals (PGI) for canary grass, flax seed and straw,
and alfalfa hay and forage.
Rationale. Directions on labels of products registered
for these uses do not contain appropriate PHI's, PSI's, and
PGI's. These intervals must be supported by data submitted to
the Agency.
17. EPA is requiring information on the manufacturing
process for MCPA products in order to evaluate whether
contamination with tetra- through heptahalogenated dibenzo-p-
dioxins or dibenzofurans occurs. Analysis of the amine salts of
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MCPA for n-nitrosamines is required.
Rationale. Polyhalogenated dibenzo-p-dioxins or
dibenzofurans may be formed during manufacture of MCPA and N-
nitrosamines may be formed during manufacture or storage of MCPA.
The Agency has identified these contaminants as being toxicologi-
cally significant. The Agency does not have sufficient data to
determine the extent and significance of the contamination.
18. The Agency will immediately review certain data as they
are submitted.
Rationale. Because of concerns regarding potential
risks from MCPA use, the Agency believes it is essential that the
following data be reviewed as they are received: Information on
the manufacturing process to assess potential dioxin and furan
formation, as well as nitrosamine analysis of the amine salts of
MCPA, groundwater contamination potential data, and the
teratology studies.
19. While data gaps are being filled, currently registered
manufacturing-use products (MPs) and end-use products (EPs)
containing MCPA may be sold, distributed, formulated, and used,
subject to the terms and conditions specified in this Standard.
However, significant new uses (including new food/feed uses) will
not be registered. Registrants must provide or agree to develop
additional data, as specified in the data tables in order to
maintain existing registrations.
Rationale. Under FIFRA, the Agency may elect not to
cancel or withhold registration even though 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. These data will be reviewed and evaluated, after
which the Agency will determine if additional regulatory actions
are necessary. Because of the quantity of data required to
maintain existing registrations, the Agency has elected not to
consider registration of any significant new uses (including new
food/feed uses) while data gaps are being filled and data
evaluated.
B. Criteria for Registration
To be registered or reregistered under this Standard,
products must contain MCPA, bear required labeling, and conform
to the product composition, acute toxicity limits, and use
pattern requirements listed in this document.
C. Acceptable Ranges and Limits
Product Compositions Standard. To be registered or
reregistered under this Standard, MPs must contain MCPA. Each MP
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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 percent.
Acute Toxicity Limits. The Agency will consider registration
of technical grade and MPs containing MCPA provided that the
product labeling bears appropriate precautionary statements for
the acute toxicity category in which each product is placed.
Use Patterns. To be registered under this Standard, MPs may
be labeled for formulation into EPs bearing federally registered
uses. The EPA Index to Pesticide Chemicals (for availability,
see page 1) lists all federally registered uses of this pesticide
ingredient, as well as approved maximum application rates and
frequencies.
The use patterns currently registered are terrestrial (food
and nonfood); aquatic (food and nonfood); domestic; and forestry.
D. Labeling
In order to remain in compliance with FIFRA, products must
bear appropriate labeling as specified in 40 CFR 156.10 and this
Standard, or must be revised to conform to those specifications.
Appendix II contains information on label requirements.
No pesticide product containing this pesticide may be
released for shipment by the registrant after October 1990 unless
the product bears amended labeling that complies with the
requirements of this Standard.
No pesticide products containing this pesticide may be
distributed or sold after October 1991 unless the product bears
an amended label which complies with the requirements of this
Standard.
The following specific information must appear on the
labeling in order for products to remain in compliance with
FIFRA:
1. Ingredient Statement. The ingredient statement for
products must list the active ingredient as:
2-methyl-4-chlorophenoxyacetic acid %
The ingredient statement for MCPA derivative products must list
the active ingredient and the equivalent percentage of MCPA, for
example:
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2-methyl-4-chlorophenoxyacetic acid, sodium salt. . . . %
(Equivalent to % of 2-methyl-4-chlorophenoxyacetic acid)
2. Use Pattern Statements. All MPs must state that they are
intended for formulation into EPs for acceptable use patterns.
Labeling must specify sites, which are listed in Use Patterns,
Section C.3. 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 pattern.
3. Precautionary Statements.
For MCPA products, as appropriate, the following
precautionary statements are required.
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 plant authority. For guidance, contact
your local State Water Board or Regional Office of the EPA."
End-Use Products
Protective Clothing Statement: For MCPA acid formulations - (This
statement does not apply to homeowner use products):
"Mixers/loaders/applicators are required to use face shields
or goggles."
For homeowner MCPA acid products:
"When mixing or applying this pesticide, use of a face
shield or goggles is required."
Environmental Hazard Statement;
"Do not apply directly to water or wetlands (swamps, bogs,
marshes, and potholes). Do not contaminate water when
disposing of equipment washwaters or rinsate."
Ground Water Contamination Statement - On all Products:
"Although highly mobile, in general, phenoxy herbicides such
as MCPA are not sufficiently persistent to reach ground
water from use as specified on product label. Most cases of
ground water contamination involving phenoxy herbicides have
been associated with mixing/loading and disposal sites. Do
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not contaminate water supplies when handling or using MCPA
pesticide products."
Cleaning of Equipment Statement; Products that require mixing
prior to application must have the following statement:
"Cleaning of Equipment: When cleaning equipment, do not
pour washwater on the ground; spray or drain over a large
area away from wells and other water sources."
4. Disposal Statements
Certain unused MCPA stocks are listed as toxic hazardous
waste under the Resource Conservation and Recovery Act (RCRA);
others may be hazardous waste because of their chemical or
physical characteristics. The following is the appropriate
pesticide disposal statement for all MCPA products, except those
labeled for household use only:
"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate, is a violation of
Federal law and may contaminate groundwater. If these
wastes cannot be disposed of by use according to label
instructions, contact your State Pesticide or Environmental
Control Agency, or the Hazardous Waste representative at the
nearest EPA Regional Office for guidance."
The labels of all products must bear the appropriate
container disposal statement (see Appendix II).
5. Product Specific Label Restrictions.
To be placed on the labels of EUP's when appropriate:
"Do not use MCPA butoxyethyl ester in greenhouses, on heavy
clay soils or where crops will be planted in a rough, cloddy
seed bed."
"Do not apply MCPA diethanolamine or MCPA isooctyl ester by
aerial application in the vicinity of sugar beets"
"Do not apply MCPA isooctyl ester around houses, recreation
sites, or similar areas."
"Do not apply MCPA sodium salt with nozzles that produce a
fine spray."
"Do not grow crayfish or catfish in treated rice fields."
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Nontaraet Plant Species Precautionary Statements;
For products with aquatic uses, use the following statement:
"Drift or run-off may adversely affect nontarget plants.
Do not apply directly to water except as specified on this
label. Do not contaminate water when disposing of
equipment washwaters."
For all other products use the following statement:
"Drift or run-off may adversely affect nontarget plants.
Do not apply directly to water or wetlands (swamps, bogs,
marshes, and potholes). Do not contaminate water when
disposing of equipment 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 follows:
A. Manufacturing use products containing this pesticide as the
sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and B1
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 restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
*Data requirements are listed in the three Tables in Appendix
I of this Registration Standard. The Guide to Tables in that
Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to all
products containing the pesticide subject to this 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.
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2. The data requirements listed in Tables A and B
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.
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 exemption3, the
data requirements listed in Table C.
2Data requirements are listed in the three Tables in Appendix
I of this Registration Standard. The Guide to Tables in that
Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to all
products containing the pesticide subject to this Registration
Standard. Table B lists product-Specific data applicable to
manufacturing-use products. The data in Tables A and B need not
be submitted by an end-use producer who is eligible for the generic
data exemption for that active ingredient.
Table C lists product-specific data applicable to end-use
products.
3If you purchase from another producer and use as the source
of your active ingredient only EPA-registered products, you are
eligible for the generic data exemption for generic data concerning
that active ingredient (Table A) and product-specific data for the
registered manufacturing use product you purchase (Table B).
Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient, or
acquire your active ingredient from a firm with ownership in common
with yours, you individually lose the exemption and become subject
to the data requirements in Table A.
2) If no producer subject to the generic data requirements
in Table A agrees to submit the required data, all end-use
producers lose the exemption, and become subject to the data
requirements in Table A.
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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.
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VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice issued
under the authority of FIFRA sec. 3(c)(2)(B). It refers to the
data listed in Table A, which are required to be submitted by
registrants to maintain in effect the regis-tration of products
containing this active ingredient.4
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation" of
a product. "Typical formulation" testing is often required for
ecological effects studies and applies to all products having that
formulation type. These are classed as generic data, and are
contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting generic
data-in response to a data request under FIFRA sec. 3(c)(2)(B) (DCI
Notice). EPA has decided, however, not to require a registrant who
qualifies for the formulator's exemption (FIFRA sec. 3(c)(2)(D) and
40 CFR 152.85) to submit generic data in response to a DCI notice
if the registrant who supplies the active ingredient in his product
is complying with the data request.
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.
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 submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed to
evaluate current uses of all products containing this active
ingredient, the uses for which such data are required, and the
dates by which the data must be submitted to the Agency.
D. How to comply with DCI requirements.
Within 90 days of your receipt of this Registration Standard,
you must submit to EPA a completed copy of the form entitled "FIFRA
Section 3(c)(2)(B) Summary Sheet" (EPA Form 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:
l. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to Jointly develop (or share in the cost of developing)
the data, but will not be submitting the data yourself. If you use
this method, you must state who will submit the data on which you
will rely. You must also provide EPA with documentary evidence
that an agreement has been formed which allows you to rely upon the
data to be submitted. Such evidence may be: (1) your letter
offering to join in an agreement and the other registrant's
acceptance of your offer, (2) a written statement by the parties
that an agreement exists, or (3) a written statement by the person
who will be submitting the data that you may rely upon its
submittal. The Agency will also
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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:
a. File with EPA a completed "Certification of Attempt to
Enter into an Agreement with other Registrants for Develop-ment of
Data" (EPA Form 8580-6, enclosed).
b. 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:
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[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 a waiver of the data requirement. If you
believe that a data requirement does not (or should not) apply to
your product or its uses, you must provide EPA with a statement of
the reasons why you believe this is so. Your statement must
address the specific composition or use factors that lead you to
believe that a requirement does not apply. Since the Agency has
carefully considered the composition and uses of pesticide products
in determining that a data require-ment applies, EPA does not
anticipate that many waivers will be granted. A request for waiver
does not extend the time-frames for developing required data, and
if your waiver request is denied, your registration may be
suspended if you fail to submit the data. The Agency will respond
in writing to your request for a waiver.
5. You request that EPA amend vour registration bv 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.
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6. You request voluntary cancellation of the registration of
vour product(s) for which the data are needed.
E. Registrant Requests Regarding Data Requirements and
Agency Responses
All requests for modification of data requirements
(inapplicability, waiver), approval of protocols or protocol
changes, or time extensions must be submitted in writing. The
original requirement remains in effect unless the Agency has
notified you in writing that it has agreed to a change in the
requirement. While being considered by the Agency, such requests
for changes in the requirements do not alter the original
requirements or extend the time allowed for meeting the
requirement.
F. Test Protocols and Standards
All studies required under this Notice must be conducted in
accordance with test standards outlined in the Pesticide Assessment
Guidelines, unless other protocol or standards are approved for use
by the Agency in writing. All testing must be conducted in
accordance with applicable Good Laboratory Practices regulations
in 40 CFR Part 160.
The Pesticide Assessment Guidelines, which are referenced in
the Data Tables, are available from the National Technical
Information Service (NTIS), Attn: Order Desk, 5285 Port Royal Road,
Springfield, VA 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic Cooperation
and Development (OECD) are also acceptable if the OECD-recommended
test standards conform to those specified in the Pesticide Data
Requirements regulation (Part 158.70). Please note, however, that
certain OECD standards (such as test duration, selection of test
species, and degradate 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.
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G. Procedures for requesting a change in
test protocol.
If you will generate the required data and plan to use test
procedures which deviate from EPA's Pesticide Assessment Guidelines
or the Reports of Expert Groups to the Chemicals Group,
Organization for Economic Cooperation and Development (OECD)
Chemicals Testing Programme, you must submit for EPA approval the
protocols you propose to use.
You should submit your protocols before beginning testing,
because the Agency will not ordinarily accept as sufficient studies
using unapproved protocols. A request for protocol approval will
not extend the timeframe for submittal of the data, nor will
extensions generally be given to conduct studies due to submittal
of inappropriate protocols. The Agency will respond in writing to
your request for protocol approval or change.
H. Procedures for requesting extensions of time.
If you think that you will need more time to generate the data
than is allowed by EPA's schedule, you may submit a request for an
extension of time.
EPA will view failure to request an extension before the data
submittal response deadline as a waiver of any future claim that
there was insufficient time to submit the data. While EPA
considers your request, you must strive to meet the deadline for
submitting the data.
The extension request should state the reasons why you believe
that an extension is necessary and the steps you have taken to meet
the testing deadline. Time extensions normally will not be granted
due to problems with laboratory capacity or adequacy of funding,
since the Agency believes that with proper planning these can be
overcome. The Agency will respond in writing to any requests for
extension of time.
I. Data Format and Reporting Requirements
All data submitted in response to this Notice must comply 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.
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J. Existing stocks provision upon suspension or
cancellation.
The Agency has determined that if a registration is suspended
for failure to respond to a DCI request under FIFRA sec. 3(c)(2)(B),
an existing stocks provision for the registrant is not consistent
with the Act. Accordingly, the Agency does not anticipate granting
permission to sell or distribute existing stocks of suspended
product except in rare circumstances. If you believe that your
product will be suspended or cancelled and that an existing stocks
provision should be granted, you have the burden of clearly
demonstrating to EPA that granting such permission would be
consistent with the Act. The following information must be included
in any request for an existing stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of existing stocks
and your estimate of the time required for their sale or
distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of FIFRA.
VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your- registrations
in effect. Product-specific data are derived from testing using a
specific formulated product, and, unlike generic data, generally
support only the registration of that product. All such data must
be submitted by the dates specified in this Registration Standard.
If you have a manufacturing use product, these data are listed
in Table B. If you have an end use product, the data are listed in
Table C. As noted earlier, the Agency has decided that it will not
routinely require product-specific data for end use products at this
time. Therefore, Table C may not be contained in this Registration
Standard; if there is no Table C, you are not required to submit the
data at this time.
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data. See
Section VI.D through J. You should note, however, that product
chemistry data are required for every product, and the only
acceptable responses are options VI.D.I. (submit data) or
VI.D.6.(cancellation of registration).
Failure to comply with the product-specific data require-ments
for your products will result in suspension of the product's
registration.
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VIII. REQUIREMENT FOR SUBMITTAL OF REVISED LABELING
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the Agency's assessment of the data supporting the product and its
uses. General labeling requirements are set out in 40 CFR 156.10
(see Appendix II - LABELING and SUMMARY). In addition, labeling
language specific to products containing this pesticide is specified
in Section IV.D of this Registra-tion standard. Responses to this
Registration Standard must include draft labeling for Agency review.
Labeling must be either typewritten text on 8-1/2 x 11 inch
paper or a mockup of the labeling suitable for storage in 8-1/2 x
11 files. Draft labeling must indicate the intended colors of the
final label, clear indication of the front panel of the label, and
the intended type sizes of the text.
If you fail to submit revised labeling as required, which
complies with 40 CFR 156.10 and the specific instructions in Section
IV.D. , EPA may seek to cancel the registration of your product under
FIFRA sec. 6.
IX. INSTRUCTIONS FOR SUBMITTAL
All submittals in response to this Registration standard must
be sent to the following address:
Document Processing Desk (RS-0017)
Office of Pesticide Programs - H7504C
U. S. Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
A. Manufacturing Use Products (MUPs) containing the subject
pesticide as sole active ingredient.
1. Within 90 days from receipt of this document, you must
submit for each product subject to this Registration Standard:
a. Generic Data Exemption Statement (EPA Form 8580-3),
if applicable, or the "FIFRA Section 3(c)(2)(B) Summary
Sheet" (EPA Form 8580-1), with appropriate attachments.
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR
152.80-152.99.
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2. Within 9 months from receipt of this document you must
submit:
a. Application for Pesticide Registration (EPA Form
8570-1).
b. Five copies of draft labeling, including the
container label and any associated supplemental
labeling.
c. Product Specific Data Report (EPA Form 8580-4).
3. Within the times set forth in Table Af 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.
4. Within the times set forth in Table B, you must submit
all product specific data.
B. Manufacturing Use Products containing the subject pesticide
in combination with other active ingredients.
1. within 90 davs from receipt of this document, you must
submit:
a. Generic Data Exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA sec. 3(c)(2)(B) Summary Sheet, with
appropriate attachments (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
c. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR
152.80-152.99.
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2. Within 9 months of receipt of this document, you must
submit:
a. Application for Pesticide Registration (EPA Form
8570-1).
b. Five copies of draft labeling, including the
container label and any associated supplemental
labeling.
c. Product Specific Data Report (EPA Form 8580-4).
3. Within the time frames set forth in Table A. you must submit
all generic data, unless you are eligible for the generic data
exemption. If for any reason any test is delayed or aborted so that
the schedule cannot be met, immediately notify the Agency of the
problem, the reasons for the problem, and your proposed course of
action.
4. Within the time frames set forth in Table B, you must submit
all product specific data.
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C. End Use Products containing the subject pesticide as sole
active ingredient.
1. Within 90 days from receipt of this document, you must
submit:
a. Generic data exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA Section 3(c)(2)(B) Summary
Sheet, with appropriate attachments (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
2. Within 9 months from receipt of this document you must
submit:
a. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
b. Five copies of draft labeling, including the
container label and any associated supplemental
labeling.
3. Within the times set forth in Table Af 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.
4. within the times set forth in Table C, you must submit all
product specific data.
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).
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2. Within 9 months from the receipt of this document, you
must submit:
a. Product Specific Data Report (EPA Form 8580-4) ,
if Table C lists required product-specific data.
b. Five 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.
4. Within the times set forth in Table C, you must submit all
product specific data.
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.
. ,
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I. DATA APPENDICES
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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 formulation" is the
test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
Table C contains product-specific data requirements that
apply only to an end use product.
i
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158.
The reference numbers accompanying each test refer to the test
protocols set out in the Pesticide Assessment Guidelines, which
are available from the National Technical Information Service,
5285 Prot Royal Road, Springfield, VA 22161.
2. Test Substance (Column 2). This column lists the
composition of the test substance required to be used for the
test, as follows:
TGAI = Technical grade of the active ingredient
PAI = Pure active ingredient
PAIRA = Pure Active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product
EP = End use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 CFR Part 158. The following
letter designations are used for the given use patterns:
A = Terrestrial, food
B = Terrestrial, non-food
C = Aquatic, food
D = Aquatic, non-food
E = Greenhouse, food
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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.
NO - EPA either possesses no data which are sufficient
to fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional
information.
5. Bibliographic citation (Column 5). If the Agency has
acceptable data in its files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no MRID
number has been assigned. Refer to the Bibliography Appendices
for a complete citation of the study.
6. Must additional data be submitted? (Column 6). This column
indicates whether the data must be submitted to the Agency. If
column 3 indicates that the Agency already has data, this column
will usually indicate NO. If column e indicates that the Agency
has only partial data or no data, this column will usually
indicate YES. In some cases, even though the Agency does not
A -7
4 /
-------
TGUIDE-3
have the data, EPA will not require its submission because of
the unique characteristics of the chemical; because data on
another chemical can be used to fulfill the data requirement; or
because the data requirement has been waived or reserved.^ Any
such unusual situations will be explained in a footnote to the
table.
7. Timeframe for submission (Column 7). If column t requires
that data be submitted, this column indicates when the data are
to be submitted, based on the issuance date of the Registration
Standard. The timeframes are generally 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.
48
-------
Table A
Generic Data Requirements for MCPA
Data Recaii rement
Test
Substance
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted?
Timeframe
For Data
Submission
158,155 - 190 - Product Chemistry
Analysis and Certification of Product
Inoredients
Product Identity and Composition
61-2 - Description of Beginning TGAI
Materials and Manufacturing
Process
61-3 - Discussion of Formation of TGAI
Impurities
No
No
00126755,00154066, Yes-1
00154075,00^54063,
00155233,00155743,
00158077,00159470
00159470,00154075, Yes2
00154063,00154066,
00126755,00158077,
00155233
1 Year
1 Year
-------
Table A
Generic Data Requirements for MCPA
Data Requirement
158.155 - 190 - Product Chemistry
62-1 - Preliminary Analysis of
Product Samples
Ul
0
Test
Substance
(cont'd)
TGAI
Does EPA
Have Data to
Satisfy This
Requi rement ?
No
Bibliographic
Citation
00159470,00154076,
00154064,40513001,
00126755,00158078,
00155743,00155234,
40077101,00079473,
00094623,00059949,
40169502,40171902,
40171802,40314302,
40314402,00105215,
40212901,40282501,
40306102,40306502,
40169501,40271501
Timeframe
Must Additional For Data
Data Be Submitted? Submission
Yes3 1 Year
Physical and Chemical Characteristics
63-2 - Color
63-2 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
63-7 - Density, Bulk Density
TGAI/PAI
TGAI/PAI
TGAI/PAI
TGAI/PAI
TGAI/PAI
TGAI
No
No
No
No
No
No
00155099,00152836,
00159470
00155099,00155743,
00159470,00152836
00155099,00155743,
00159470,00152836
00155099,00155743,
00159470,00152836
00155743
00155099,00155743,
Yes4 1 Year
Yes4 l Year
Yes4 1 Year
Yes4'5 1 Year
Yes4'6 1 Year
Yes4 1 Year
or Specific Gravity
00159470,00152836,
00154067
-------
Table A
Generic Data Requirements for M3PA
Data Requirement
pnysical
and
Chemical
Test
Substance
Characteristics (cont'd)
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Most
Data
Additional
Be Submitted?
Timeframe
For Data
Submission
63-8 - Solubility TGAI or PAI No
63-9 - Vapor Pressure
63-10 - Dissociation Constant
TGAI or PAI No
TGAI or PAI No
63-11 - Octanol/Water Partitioning PAI
Coefficient
63-12 - pH
63-13 - Stability
Other Requirements;
64-1 - Submittal of Samples
TGAI
TGAI
N/A
NO
NO
N/A
00155099,00155743,
00159470,40470101,
40471802,00152836
00155099,00155743,
00159470,40471803,
00152836,00126755
00159470,40471801,
00155743
00159470,00152836,
00154067,00126755
00155099,00155743,
00159470,60152836
00155743,00152836
N/A
Yea"4
Yes-
Yes-
Yes4'7
Yes-
No
1 Year
1 Year
1 Year
1 Year
1 Year
1 Year
158.155 - 190 - Product Chemistry - Footnotes - All numbers in parentheses refer to EEA registration numbers.
^Complete information must be provided regarding the nature of the process (batch or continuous), the relative amounts of
beginning materials and the order in viiich they are arHarl, the equipnent used, reaction conditions, the chemical equations
for each intended reaction (including a flow chart), the duration of each step of the process, purification procedures, and
quality control measures. In addition, the name and address of the manufacturer, producer, or supplier of each beginning
-------
Table A
Generic Data Requirements for
158.155 - 190 - Product Chemistry - Footnotes
material used in the manufacture of each product must be provided, along with, information, regarding the properties of those
materials. This information is required for all manufacturing-use products (HA Registration Numbers presented
parenthetically) except the Riverdale 94 percent T acid (228-200) and 91 percent T isooctyl ester (228-198) and the EPfiF 85
percent T acid alternate formulation (7969-34). These requirements may be satisfied for the following products for which
selected information is required: (i) The nature of the process, and the relative amounts of beginning material used are
required for the Dow 93.3 percent Ts (464-585 and 464-595). (ii) The relative amounts of beginning materials, the name and
quality control measures are required for the Dow 94 percent T (464-580). (iii) Data must be submitted regarding the nature
of the process, the duration of each step, chemical equations of intended reaction, quality control measures, and the name
and address of the manufacturer, producer, or supplier of each beginning material used in the manufacture, for the Gilmore
94 and 95 percent IS (42545-24 and 42545-9, respectively), (iv). The properties of the beginning materials are required
for the 94 percent T (42545-24). (v) The nature of the process, the relative amounts of beginning materials, chemical
equations, the duration of each intended reaction, equipment used, quality control measures, and the name and addresses of
the manufacturer, producer, or supplier of each beginning material used in the manufacture of each product, along with
information regarding the properties of those materials for the Kemisk Vaerk Kogen A/S 92 percent T (11636-3). (vi) The
nature of the process, the relative amount of beginning materials, and quality control procedures for the A.H. iVbrks 93
percent and 94 percent Ts (15440-7 and 15440-9, respectively) and the duration of each step and the names and addresses of
manufacturers, producers, or suppliers of the beginning material for the 94 percent T isooctyl ester (15440-9). (vii)
Rhone-Poulenc and A.H. Marks must specify which technical product is manufactured by the submitted processes, and
information must be provided regarding the nature of the process, the relative amounts of beginning materials and the order
in which they are added, equipment used, reaction conditions, and duration of each step of the process for the Rhone-Roulenc
product, and the nature of the process, relative amounts of beginning materials, the duration of each step, and quality
control measures, and the names and addresses of manufacturers, producers, or suppliers of the beginning materials for the
A.H. IVbrks product. These data requirements do not apply to the following products (228-200, the alternate formulation of
7969-34, and 228-198).
2A detailed discussion of all impurities that are or may be present at > 0.1 percent, based on knowledge of the beginning
materials, chemical reactions (intended and side) in the manufacturing process, and any contamination during and after
production, including the formation of dibenzo-p-dioxins and dibenzofurans, must be submitted for all manufactoiring-use
products except the Riverdale 94 percent T acid (228-200) and 91 percent isooctyl ester (228-198) and the EftSF 85 percent T
acid alternate formulation (7969-34). These requirements may be satisfied for the following products by a discussion of the
formation of selected impurities: the Gilmore 95 percent T acid (42545-9); the Dow T acid (464-580); the Dow 93.3 percent T
isooctyl ester and butoxyethyl ester (EE& Registration Nos. 464-585 and 464-595, respectively); the unspecified Rhone-
Poulenc T acid; and the Gilmore 94 percent isooctyl ester (42545-24).
•^Preliminary analysis must be performed on five representative samples of all manufacturing-use products except the Riverdale
94 percent T acid (228-200) and 91 percent T isooctyl ester (228-198) and the E&SF 93.6 percent T acid alternate formulation
-------
Table A
Generic Data Requirements for
158.155 - 190 - Product Chemistry - Footnotes
plus all impurities present at > 0.1 percent or of toxLcological significance, including dibenzo-p-dioxins and
dibenzDfurans. These requirements nay be satisfied for the following products by sutmission of certain data. Rme-Rxilenc
must identify the T acid product for viiich data are available and submt these data for the remaining registered T acid
product; in addition, validaticn studies and data depicting bUbenzo-p-dioxins and dibenzofurans are required for both T
acids. Dew must specify the number of batches of T acid (464-580) and T iscoctyl ester (464-585) analyzed, validation
studies (active ingredient and iirpurities), and data depicting dibenzo-p-dioxins and dibenzofurans for both products. Dow
must also submit data regarding the impurities in the T iscoctyl ester (464-585). Kara.sk must define impurities abbreviated
on the CSF for the T acid (11636-2) and submit information regarding the number of batches analyzed and data depicting
dibenzofurans and validation studies for this product. A.H. IV&rks most identify the T acid product for Vvfriich data are
available and submit these data for the reniaining registered T acid product; in addition, validation studies and data
depicting dibenzo-p-dioxins and dibenzofurans are required for both T acids. Gilirore must submit data for additional
impurities including dibenzofurans, identify the unknown, specify the number of batches analyzed, and submit validation data
for the T acid (42545-9). Gilmore must also sutmit data for additional inpurities including dibenzo-p^oxins and
dibenzofurans in five batches and sutmit validation data for the T iscoctyl ester (42545-24). j
^Data regarding physiccchemical characteristics (color, physical state, odor, melting point, boiling point, specific gravity,
solubility, vapor pressure, dissociation constant, partition coefficient, pH, and stability) as required in 40 CFR 158.120
and more fully described in the Pesticide Assessment Guidelines, Subdivision D, Reference ftbs. 63-2 to 63-13, must be
submitted for technical products except the Riverdale 94 percent T acid (228-200) and the 91 percent T iscoctyl ester (228-
198) and the EftSF 85 percent T acid alternate formulation (7969-34). The requirements may be satisfied for the following
products by sutmission of data for selected properties: color, physical state, and odor (359-737, 7969-34, 11636-2, 11636-
3, 42545-9); melting point (7969-34, 11636-2, 42545-9); boiling point (359-737, 11636-3); and density (359-737, 464-580,
464-582, 464-595, 7969-34, 11636-2, 11636-3, 15440-8, 15440-9, 42545-9, 42545-24). See Table B for additional requiraraits
for data on physiccchemical characteristics of technical products that are also manufarturing-use products.
5Data on melting point are required if the technical chemical is a solid at roan terrperature.
on boiling point are required if the technical product is a liquid at roan tenperature.
on pH are required if the test substance can be diluted or dispersed in water.
-------
Table A
Generic Data Requirements for MCPA
Data Requirement
158.240 Residue Chemistry
171-2 - Chemical Identity1
171-3 - Directions for use
171-4 - Nature of the residue
(Metabolism)
- Plants
171-4 - Nature of the residue
(Metabolism)
Ui - Livestock
•Ł»•
171-4 - Residue analytical
methods
Test
Substance
PAIRA
PAIRA and
plant
metabolites
TGAI and
metabolites
Does EPA
Have Data to
Satisfy This
Requi rement ?
(See Index)
Partially
Partially
Partially
Bibliographic Must Additional
Citation Data Be Submitted?
00005575,00041633, Yes2
00053734,00053755
00004624,00004625, Yes3'4
00053734,00053755,
00027042
00004439 , 00004449 , Yes5
00004453,00004491,
00004492,00004493,
00004627,00004632,
00004724,00004766,
00004787,00004822,
00004993,00005575,
00102704
Timeframe
For Data
Submission
2 Years
2 Years
2 Years
171-4 - Storage stability
TEP and No
metabolites
Yes6'7
2 Years
-------
Table A
Generic Data Requirements for MCPA
Data Reoui r ement
158.240 Residue Chemistry - (cont'd)
171-4 - Magnitude of the residue
in plants**
Legume Vegetables
, - Beans
{
- Peas
(Ji Foliage of Legume
Ul Vegetables
- Pea vines and hay
Cereal Grains
- Barley
- Oats
- Rice
- Rye
- Sorghum
- Wheat
Test
Substance
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
Does EPA
Have Data to
Satisfy This
Requirement?
Partially
Partially
Yes
Partially
Partially
Partially
No
Partially
Partially
Timeframe
Bibliographic Must Additional For Data
Citation Data Be Submitted? Submission
00004453 Yes9'10
00004443,00004773 Yes11'12
00004443 NO
00004613,00005567 Yes13'14
00078931
00023687 Yes15'16
00004764,00102704 yes17'18'19
Yes20'21
00004993 yes22'23
00004651,00004655 Yes24'25'26
2 Years
2 Years
2 Years
2 Years
2 Years
2 Years
2 Years
2 Years
00004659,00025394
00005575
-------
Table A
Generic Data Requirements for
Test
Data Requirement Substance
158.240 Residue Chemistry - Continued
Forage. Fodder, and
Straw of Cereal Grains
- Barley forage and straw
- Oat forage and straw
- Rice straw
t_n - Rye forage and straw
ON
Sorghum forage and
fodder
- Wheat straw
Grass Forage and Hay
- Canary grass
- Pasture and rangeland
grass
Nongrass animal feeds
- Alfalfa forage and hay
- Clover forage and hay
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
Does EPA
Have Data to
Satisfy This
Requirement?
Partially
Partially
Partially
No
Partially
Partially
Yes
Partially
No
Bibliographic Must
Citation Data
00004613,00005567
00023687
00004764
00004993
00004993
00004651,00004659,
00025394,00005575
00084292
00004449
Additional
Be Submitted9
Yes27
Yes28
Yes29'30
Yes31
Yes32
yes33,34,35
yes36 , 37 ,
Yes38
Yes39
Yes40
Timeframe
For Data
Submission
2 Years
2 Years
2 Years
2 Years
2 Years
2 Years
2 Years
2 Years
2 Years
2 Years
- Lespedeza forage and
hay
TEP
No
Yes
41
2 Years
-------
Table A
Generic Data Requirements for MCPA
Does EPA
Have Data to Timef rame
Test Satisfy This Bibliographic Must Additional For Data
Data Requirement _ Substance Requirement? Citation _ Data Be Submitted? Submission
158.240 Residue Chemistry - (cont'd)
- Trefoil forage and hay TEP No Yes42 2 Years
- Vetch forage and hay TEP No Yes43 2 Years
Miscellaneous
Commodities
- Flax TEP No Yes44'45 2 Years
171-4 Magnitude of residue in TGAI or Partially 00004625,00004626 Reserved46
Meat/Milk/Poultry/Eggs metabolites
158.240 Footnotes
•4ne same chemical identity data are required as under 158.120, with emphasis on impurities that could constitute
residue problems. Refer to Product Chemistry Data Requirements tables.
2Data depicting the distributicn and metabolism of ring-labeled t^MCm in or on the grain and straw of wheat. A
ccnpletely characterized test substance representative of technical M3A (including impurities) used in comercial
formulations must be applied postemergence at rates sufficiently high to permit characterization of 14C-residues.
The identities and quantities of residues in or on nature plant parts must be determined in order to elucidate
terminal residues. Representative samples must also be analyzed by proposed enforcement methods to ascertain that
all residues of concern are determined.
-^Metabolism studies utilizing ruminants and poultry. Animals must be dosed orally for a minimum of 3 days with
uniformly ring-labeled [14-hvCPA at a level sufficient to mate residue identification and quantification possible.
Milk and eggs must be collected twice a day during the dosing period. Animals must be sacrificed within 24 hours of
the final dose. The distributicn and identity of residues must be determined in milk, eggs, liver, kidney, muscle,
and fat. Samples from these studies must also be analyzed using proposed enforcement methods to ascertain that the
methods are capable of adequately recovering and identifying all residues of toxicological concern.
-------
•Sable A
Generic Data Requirements for MIA
158.240 Footnotes - (cont'd)
4Data depicting the nature of MIA residues in swine are also required if the required metabolism studies with
ruminants and poultry reveal that the metabolism of MIA in these animals differs fron that in rats.
SRepresentative plant samples, ruminant tissues and milk bearing residues of MIA must be subjected to analysis
by multiresidue protocols I, II, in, and IV in B?M \fol. I. These protocols are available fron the rational
Technical mfonnaticn Service (NITS) under Order No. EB203734/AS.
6Sanples bearing field weathered residues or fortified samples of one representative oomodity from each crop group
and representative animal oomcdities (meat, milk, eggs) must be analyzed immediately after harvest or
fortification and again after storage intervals that are equivalent to those reflected in all previously submitted
and currently requested data. Storage conditions for the samples must also reflect those in previously submitted
and currently requested data. The chosen intervals must also allow for unforeseai delays in sample storage. In
laboratory tests using fortified samples, the pure active ingredient and pure metabolites (if necessary) must be
used. However, if field weathered samples are used, the test substance must be a typical end-iise product. For
additional guidance on conducting storage stability studies, the registrant is referred to an August 1987
(^n .!ositicn Document on the Effects of Storage on the Validity of Pesticide Residue Data available from NETS under
CD order No. IB88112362/AS.
^information on the intervals and conditions of storage must be submitted for the samples of sorghum grain and
sorghum forage reported in MOD No. 00004493.
8If it is determined that the data on rutrosamines and the data requested on dioxins in end-use products indicate
that these impurities may occur in or on food items at toxicologically significant levels, data depicting the
levels of these impurities in or on raw agricultural and processed commodities may be required.
9Data depicting residues of MIA in or on dried beans harvested following application of the 4 Ib/gal FE of the
formulation diethylamine salt of MIA at 1.5 Ib ae/A, made when the plants are 6 inches tall. The tests must be
conducted in CA. The registrant must amand all pertinent labels to specify a HH based on the minimum interval
expected between application at the 6-inch stage and harvest. Adequate residue data must be available reflecting
harvest at the proposed interval. Alternatively, the registrant may elect to cancel this use permitted under EEA
SIN NO. CA-760142.
10Use directions must be proposed and appropriate supporting residue data submitted for the raw agricultural
oomrcdities bean vines and bean hay. Alternatively, the registrant may amend all pertinent product labels to
impose a restriction of the feeding of these commodities to livestock.
-------
Table A
Generic Data Requirements for MIA
158.240 Footnotes - (cont'd)
(depicting residues of MIA in or on peas (succulent and dry) harvested after application of representative EC
and 3C/L formulations of the diethylamine salt of MIA at 0. 37 Ib ae/A, each fontulation applied in separate
tests. Applications are to be made when the plants are 8 inches tall. Aerial and ground applications nust be
made in 15 galA- The tests must be conducted in wr (28%) or MJ (22%) , W&. (17%) , CR (7%) , and in EE (3%) , States
that collectively accounted for ca. 80 percent of 1985 U.S. pea production and represent the major U.S. growing
regions (Agricultural Statistics , 1986, page 162) . The registrant must propose a ffll based on the nunimum
interval expected between application to 8-inch plants and harvest.
•^Data depicting residues of MIA in or on peas (succulent and dry) harvested after application of the 1.86 Ib/gal EC
and 2 Ib/gal SC/L formulations of the sodium salt of M3A at 0.37 Ib ae/A, each formulation applied in separate
tests using aerial equipment. Applications are to be made when the plants are 3 inches tall. The tests must be
\ conducted in WI (28%) or W (22%) , VA (17%) or CR (7%) , and in EE (3%) , States that collectively accounted for ca.
80 percent of 1985 U.S. pea producticn and represent the major U.S. growing regions, lire registrant must propose a
HIE based on the minimum interval expected between application to 3-inch plants and harvest.
(ji 13Residue data required for wheat will be translated to barley.
\O 14Processing data required for wheat will be translated to barley.
•L^Resicye data required for wheat will be translated to oats.
16Processing data required for wheat will be translated to oats.
•^Bata depicting residues of MIA in or on rice grain harvested following postemergence application of the 2 Ib/gal
SC/L fontulation of the sodiun salt and representative EC formulations of the sodium salt and butoxyetnyl ester
forms of MIA at 1.25 Ib ae/A applied with ground equipment, earn formulation in a separate test. Also, data are
required depicting residues of MIA in or on rice grain harvested following postenergence application of
representative EC and SC/L fornulations of the diethylamine salt of MIA at 1.4 Ib ae/A, applied with aerial
equipment in 3 gal/A and with ground equipment in 8 gal/A in separate tests. Tests with the sodium salt must be
conducted in CA where this use in permitted. The tests using the other formulations must be conducted in AR (40%) ,
LA (15%) , or TX (13%) and in CA (22%) , which collectively account for ca. 90 percent of the 1985 U.S. rice
production (Agricultural Statistics, 1986, page 21) . The registrant may satisfy some of these data requirements by
providing additional information on the tests described in MOD Nbs. 00004764 and 00102704.
18The registrant must amend all pertinent product labels to specify a maximum nurrber of applications per season and
a HfE based on the latest permitted postemergence application and harvest. The data submitted to support the
established tolerance must reflect these proposed restrictions.
-------
Table A
Generic Data. Requirements for M3A
158.240 Footnotes - (cont'd)
19Data depicting the potential for cxrcentration of residues in hulls, bran, polished rice, and grain dust processed
fron rice grain bearing measurable weathered residues. If the data indicate a potential for concentration of
residues in any of these processed commodities, an appropriate food or feed additive tolerance must be proposed.
20Etesidue data required for vheat will be translated to rye.
^Processing data required for wheat will be translated to rye.
^Data depicting the potential for concentration of residues in flour, starch, and grain dust from sorghum grain
bearing measurable weathered residues. If the d3ta indicate a potential for concentration of residues in any of
these coimodities during processing, an appropriate food or feed additive tolerance must be proposed.
23The registrant must amend all pertinent product labels to specify a maximum nuntoer of applications per season and
a HE based on the latest permitted postanergence application and harvest. The data submitted to support the
established tolerance must reflect these proposed restrictions.
24Cata depicting residues of M3A in or on wheat grain harvested following application, made at the boot stage, of
each of the following formulations in separate tests: (i) the 1.86 Ib/gal EC formulation of the sodium salt at
1.5 Ib ae/A; (ii) tite 2 Ib/gal SC/L formulation of the sodium salt at 1.5 Ib ae/A; (iii) representative EC and
SC/L formulations of the diethylamine salt at 1.4 Ib ae/A; and (iv) a representative EC formulation of the
isocctyl ester at 1.5 Ib ae/A. Each fornulation must be applied using aerial and ground equipment. The tests
must be conducted in KS (18%) or NE (4%), ND (13%), and GK (7%) or TX (8%), States that accounted for ca. 60
percent of the 1985 total U.S. wheat production and represait the major domestic wheat growing regions
(Agricultural Statistics, 1986, page 6).
25The registrant must amend all pertinent product labels to specify a maximum number of applications per season and a
Hn based on the nunimum interval expected between the boot stage and harvest. The data submitted to support the
established tolerance must reflect these proposed restrictions.
26Data depicting the potential for ocrcentraticn of residues in flour, bran, middlings, shorts, and grain dust from
wheat grain bearing measurable weathered residues. If the data indicate a potential for concentration of residues
in any of these comodities during processing, an appropriate food or feed additive tolerance must be proposed.
27Residue data required for wheat will be translated to barley.
28Residue data required for wheat will be translated to cats.
29Eata depicting residues of MZEA in or on rice straw harvested following postemergerce application of representative
EC and SC/L formulations of the sodium salt and butaxyethyl ester forms of M3A at 1.25 Ib ae/A applied with ground
equipment, each formulating in a separate test. Also, data are required depicting residues of MZFA in or on rice
straw harvested following postenHrgence application of representative EC and SC/L formulations of the diethylamine
salt of M3A at 1.4 Ib ae/A, applied with aerial equipment in 3 gal/A and with ground equipment in 8 gal/A in
separate tests. The sodium salt must be conducted in CA. The tests using the other formulations must be conducted
in AR (40%), LA (15%) or TX (13%), and in CA (22%), which collectively accounted for ca. 90 percent of the 1985
-------
Table A
Generic Data Requirements for MZEA
158.240 Footnotes - (cont'd)
registrant nust amend all pertinent product labels to specify a maxinum number of applications per season and a
ffll based on the latest permitted postanergence application and harvest. The data submitted to support the
established tolerance nust reflect these proposed restrictions.
31Residue data required for wheat will be translated to rye.
32The registrant nust amend all pertinent product labels to specify a maximum number of applications per season and a
ffll based on the latest permitted postanergence application and harvest. The data submitted to support the
established tolerance nust reflect these proposed restrictions.
33Data depicting residues of IVCFA in or on wheat straw harvested following application, made at the boot stage, of
each of the following fornti.lat.ions in separate tests: (i) a representative EC formulation of the sodium salt at
1.5 ae/A; (ii) a representative SC/L fornulation of the sodium salt at 1.5 Ib ae/A; (iii) representative EC and
9C/L formulations of the diethylamine salt at 1.4 Ib ae/A; and (iv) a representative EC fornulation of the isooctyl
ester at 1.5 Ib ae/A. Each fornulation nust be applied using aerial and ground equipment. The tests nust be
conducted in KS (18%) or NE (4%) , ND (13%) and CK (7%) or TX (8%) , States that accounted for ca. 60 percent of the
1985 total U.S. wheat production and represent the major domestic wheat growing regions (Agricultural Statistics ,
1986, page 6). |
34The registrant must amend all pertinent product labels to specify a maxinum number of applications per season and a
ffll based on the minimum interval expected between the boot stage and harvest. The data submitted to support the
established tolerance must reflect these proposed restrictions.
35Tblerances nust be proposed and appropriate supporting residue data submitted for wheat forage and hay. Alterna-
tively, the registrant may amand all labels to bear feeding and grazing restrictions.
36The registrant must amend all pertinent product labels to specify a maxinum. number of applications per season and a
ffll based on the latest permitted postemergence application and harvest. A pregrazing interval nust be proposed
also. The data submitted to support the established tolerances must reflect these proposed restrictions.
37A tolerance nust be proposed and appropriate supporting residue data submitted for the raw agricultural conrcnodity
canary grass forage.
38Data depicting residues of IVCFA in or on pasture grass forage and hay harvested 7 and 21 days, respectively,
following the last of two applications of representative EC and 3C/L fornulations of the sodium salt and an EC
formulation of the isooctyl ester of MJA at 1.5 Ib ae/A and representative EC andj3C/L formulations of the
diethylamine salt at 2 Ib ae/A. Also, data are required depicting residues of IVCFA in or on rangeland grass
forage collected on the day of the final treatment. Each formulation must be applied in the spring and in the
fall using ground and aerial equipment in separate tests. Tests on pasture grasses nust be conducted in KY (6%)
or TN (4%) , MD (11%) and representative of KS (4%) , and «R (3%) , NY (4%) or m (4%) , and TX (13%) and
representative of SD (12%) , CK (5%) , and representative of KS (8%) and CR (4%) , States that collectively
-------
Table A
Generic Data Requirements for MIA
158.240 Footnotes - (cont'd)
accounted for ca. 50 percent and ca. 60 percent, respectively, of pasture and rangeland grass production (1982
Census Acnriculture. \tol. 1, Part 51, pages 330-331). The registrant nust propose a FHI for application of the
sodium salt fornulations; the available data indicate that a EHI of 21 days would be appropriate. "Preslaughter"
intervals nust be deleted from all pertinent labels.
39Cata depicting residues of M3EA in or on alfalfa and alfalfa hay harvested 7 days following application of
representative EC and SC/L fornulations of the sodium salt and diethylamine salt forms of MIA at 0.5 Ib ae/A and
a representative SC/L fornulation of the diethanolamine salt at 0.7 Ib ae/A using ground and aerial equipnent.
The registrant nust propose a FHI based on the mininum interval expected between the latest pentdtted
postemergence application and harvest. A pregrazing interval and a FHI nust be proposed for application of the
diethylamine and diethanolamine salt forms. A FHI must be proposed for application of the sodium salt
fornulations. The rfca-a sutmitted to support the established tolerances nust reflect these proposed restrictions.
Tne tests nust be conducted in CA (7%), ID (5%), IA (7%), and representative of NE (4%), and SD (6%), MI (4%), and
MSf (7%) or WI (12%), States that collectively accounted for ca. 50 percent of U.S. alfalfa production and represent
the major U.S. alfalfa growing region (1982 Census of Agriculture. Vol. 1, Fart 51, page 328).
40Residue data required for alfalfa will be translated to clover.
^Residue data required for alfalfa will be translated to lespedeza.
^Residue data required for alfalfa will be translated to trefoil.
4%tesidue data required for alfalfa will be translated to vetch.
44Cata depicting residues of MIA in or on f laxseed and flax straw harvested following application of representative
EE and SC/L fornulations of the sodium salt of MIA at 1 Ib ae/A, the diethylamine salt of MIA at 0.5 Ib ae/A,
the diethanolamine salt at 0.37 Ib ae/A, and the isooctyl or butoxyethyl ester at 0.25 Ib ae/A. Each fornulation
nust be applied using ground and aerial equipnent. Ihe tests must be conducted in MST, ND, or SD, States that
collectively accounted for 100 percent of the 1985 U.S. flax production (Agricultural Statistics. 1986, page 115).
The registrant must propose a FHI and pregrazing interval and all data submitted in support of the established
tolerances nust reflect these restrictions.
45Data depicting the potential for concentration of residues in oil and meal processed from flaxseed bearing
neasurable weathered residues. If the data indicate a potential for concentration of residues in either of these
comcdities, an appropriate food or feed additive tolerance nust be proposed.
46NunBrous data gaps exist pertaining to the data requirements on livestock feed items; therefore, a maximum
theoretical dietary intake of MIA by livestock cannot be estimated. In addition, the metabolism of MIA in
animals is not adequately understood. Upon receipt of the data requested on anijiHl metabolism and residues in or
on feed items, the adequacy of the established tolerances for residues in animal conmodities will be assessed.
-------
Table A
Generic Data Requirements for MZPA Acid/Sodium Salt
Test
Data Requirement Substance
§158.340 - Toxicology
ACUTE TESTING
81-1 - Acute Oral - Rat
81-2 - Acute Dermal - Rat
81-3 - Acute Inhalation
- Rat
81-4 - Eye Irritation
- Rabbit
81-5 - Dermal Irritation
TGAI
TGAI
TGAI
TGAI
TGAI
Use
Patterns
A,B
A,B
A,B
A,B
A,B
Does EPA
Have Data to
Satisfy This
Requirement?
Yes
Yes
Yes
Yes
No
Bibliographic
Citation
00021972
00144735
40053101
00021974
Most Additional
Data Be Submitted?
No
No
No
No
Yes
Timeframe
For Data
Submission
1 Year
- Rabbit
81-6 - Dermal
Sensitization
- Guinea Pig
81-7 - Acute Delayed
Neurotoxic ity
- Hen
TGAI
TGAI
A,B
N/A
No
NO
Yes
NO1
1 Year
-------
Table A
Generic Data Requirements for fCPA Acid/Sodium salt
Data
S158
Requirement Si
Test
jbstance
Use
Patterns
.340 - Toxicology (cont'd)
Does EPA
Have Data to
Satisfy This Bibliographic
Requirement? Citation
Timeframe
Must Additional For Data
Data Be Submitted? Submission
SUBCHRCNIC TESTING
82-1
82-2
82-3
82-4
82-5
- 90-Day Feeding
- Rodent
- Nonrodent
- 21-Day Dermal
- 90-Day Dermal
- 90-Day Inhalation
Rat
- 90-Day
Neurotoxic i ty
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A,B
A,B
A,B
A,B
A,B
A,B
Yes 00165471
Yes 00152867
NO
NO
NO
No
No
No
Yes 2 Years
No2
No2
No3
CHRGNIC TESTING
83-1
83-2
- Chronic Toxicity -
- Rodent
- Nonrodent
- Qncogenicity
- Rat
- Mouse
TGAI
TGAI
TGAI
TGAI
A,B
A,B
A,B
A,B
Yes 40634101
Yes 00164352
Yes 40634101
Yes 40792301
No
No
No
No
-------
Table A
Generic Data Requirements for MCPA Acid/Sodium Salt
Test
Data Requirement Substance I
S158.340 - Toxicology (cont'd)
CHROMIC TESTING
83-3 - Teratogenicity
- Rat TGAI
- Rabbit TGAI
83-4 - Reproduction TGAI
- 2-Generation
ON
C_n 84-2 - Gene Mutation TGAI
84-2 - Chromosomal
Aberration TGAI
84-2 - Other Mechanisms TGAI
of Mutagenicity
85-1 - General Metabolism PAI or
PAIRA
Special Neurotoxicity TGAI
Testing
5158.340 - Toxicoloqy - Footnotes
•%iis test is not required since MZEA does
^Uris study is not required to support the
%ince an acute neurotoxicity study is not
Use
^atterns
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
not have a
registered
Does EPA
Have Data to
Satisfy This Bibliographic Must Additional
Timeframe
For Data
Requirement? Citation Data Be Submitted? Submission
No Yes4
No Yes4
Yes 40041701 No
No Yes
Yes 40027501 NO
Yes 00148720 NO
Yes 00041634 NO
No Yes5
chanical structure similar to organpphosphates.
use patterns.
required, this study is not presently required.
2 Years
2 Years
1 Year
1 Year
-------
Table A
Generic Data Requirements for MIA ^id/Sodium Salt
S158.340 - Toxicology (cont'd)
^Originally not required in the 1982 Registration Standard based upon data evaluated at that tine; ?igency reevaluaticn of the
teratology data has concluded that the studies are not adequate to fin the data requirements.
SA. protocol nust be submitted and approved by the Agency prior to submission of this study, Far such studies the following
nust be addressed. l)An experimental animal species nust be chosen that has been shown to respond to a "chemical known to
produce sensory paresthesiaes like those seen most often in the case reports." 2)Parameters observed nust have been shown
to detect the effects, in experimental animals, of a known neurotoxin having this type of effect in man. 3)The dose tested
must be a single large dermal dose, in the order of an IDjoi viiich produces obvious signs of toxicity. The dose may be
applied to the skin of the back and the test animals observed for at least 30 days after dosing. 4)The compound tested
should be M3A acid or the sodiun salt and each of the organic amine salts and organic esters.
-ON
-------
Table A
Generic Data Requirements for Organic Amines/Esters of M3?A
Data
S158
Regui rement Sj,
.340 - Toxicology
Test
ibstance
Use
Pattern
Does EPA
Have Data to
Satisfy This
Requi rement?
Bibliographic Mist
Citation Data
Additional
Be Submitted?
Timeframe
For Data
Submission
ACUTE TESTING:
81-1
81-2
81-3
81-4
81-5
81-6
81-7
- Oral - Rat
- Dermal
- Inhalation - Rat
- Eye Irritation
- Rabbit
- Dermal Irritation
- Rabbit
Irritation
TGAI
TGAI
TGAI
TGAI
TGAI
A,B
A,B
A,B
A,B
A,B
Partially
Partially
Partially
Partially
Partially
00160158,00156458
00156459,00160157
00146317,40076201,
00156460
00156456,00145865
00160160,40352001,
00156457
Yes
Yes
Yes
Yes
Yes
2 Years
2 Years
2 Years
1 Year
1 Year
- Dermal Sensitization
- Guinea Pig
- Acute Delayed
Neurotoxic i ty
- Hen
TGAI
TGAI
A,B
N/A
Partially
No
40352101
Yes
No1
1 Year
SUBCHRONIC TESTING;
82-1
82-2
- 90-Day Feeding -
Rodent
Nonrodent
- 21-Day Dermal
TGAI
TGAI
TGAI
A,B
A,B
A,B
No
No
No
Yes
Yes
Yes
2 Years
2 Years
2 Years
-------
Table A
Generic Data Requirements for Organic Amines/Esters of
Test
Data Requirement Substance
§158.340 - Toxicology (cont'd)
Does EPA
Have Data to Timef rame
Use Satisfy This Bibliographic Must Additional For Data
Pattern Reouirement? Citation Data Be Submitted? Submission
SUBCHRONIC TESTING; (cont'd)
82-3 - 90-Day Dermal
82-4 - 90-Day Inhalation
Rat
82-5 - 90-Day
Neurotoxic i ty
ON
OO CHRONIC TESTING;
83-1 - Chronic Toxicity -
- Rodent
- Nbnrodent
83-2 - Oncogenicity
- Rat
- MDuse
83-3 - Teratogenicity
- Rat
- Rabbit
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A,B No No2
A,B No No2
o
A,B No NbJ
A C
A,B NO No4'13
A,B NO NO4'5
A C
A,B NO Nb4'b
A,B NO NO4'5
A,B No Yes 2 Years
A,B No Yes 2 Years
83-4 - Reproduction
- 2-Generation
TGAI
A,B
NO
NO4'5
-------
Table A
Generic Data Requirements for Organic Amines/Esters of MCPA
Test
Data Reouirement Substance
3 158. 340 - Toxicology (cont'd)
MUTAGENICTTY TESTING
84-2 - Gene Mutation TGAI
84-2 - Chromosomal
Aberration TGAI
84-4 - Other Mechanisms TGAI
of Mutagenicity
SPECIAL TESTING
85-1 - General Metabolism PAI or
PAIRA
Special Neurotcxicity TGAI
Study
Does EPA Must Additional
Have Data to Data Be Submitted Timeframe
Use Satisfy This Bibliographic Under FIFRA Section For Data
Pattern Reouirement? Citation 3rc)(2UB)? Submission
A,B
A,B
A,B
A,B
A,B
No
No
No
No
No
%his test not required since M3& dees not have a chemical structure similar to
2This study is not required to support the registered use patterns.
•^Sinoa an acute neurotoxicity study is not required, this study is not presently
not organophosphates.
^Required if measurable residues of the organic amines or ester moieties are pres
Yes 1 Year
Yes 1 Year
Yes 1 Year
Yes 2 Years
Yes6 1 Year
organcphosphates.
required. Amines\esters of MCPA are
sent on the RACs or processed foods.
5Requiced if the acute toxicology studies required show significant differenoes in toxic effect(s) (change in toxicity
category) coipared with MCPA acid and/car its sodium salt.
-------
Table A
Test
Use
F&ttem
Dees EE&
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Mjst Additional
Data Be Submitted
Utter FEFRA Section
3fc)f2UB)?
Timeframe
Par Data
Submission
§158.340 - Itaxioolocty footnotes (cont'd)
^A protocol nust be submitted and approved by the Agency prior to submission of this study. For such studies the
following nust be addressed. l)An e>qperimental animal species nust be chosen that has been shovn to respond to a
"chemical knovn to produce sensory paresthesiaes lite those seen meet often in the case reports." 2)Eferameters
observed nust have been shcvn to detect the effects, in experimental animals, of a known neurotoxin having this type of
effect in nan. 3)1116 dose tested nust be a single large dermal dose, in the order of an IDio vhioh produces obvious
signs of teocLcity. The dose nay be applied to the skin of the back and the test animals observed for at least 30 days
after dosing. 4) The oompound tested should be M3A acid or the sodium salt and each of the organic amine salts and
organic esters.
-------
Table A
Generic Eata Requirements for M3A Acid
Data Requiranent
158.290 EnVlJXSlYSltdJ
DEGRADATION STtDIES-I
161-1 Hydrolysis
Inotodegradation
161-2 m Water
161-3 Cn Soil
161-4 In Air
Test Use
Substance Rittem
Fate
AB:
TGM or JMRA ABC
TGAI or IMRA ABCDG
TGPiI or EMRA A
TGU: or IMRA A
Bs
Does BEA
Have Data to
Satisfy This
Requiranent?
No
No
No
No
TiitefraiTE
BibliografJiic Must Additional RDr Data
Citation Data Be Submitted? Submission
Yes 1 Year
Yes 1 Year
No
Reserved1
162-1 - Aerobic Soil TGŁ or
ABG
162-2 - Anaerobic
Soil
162-3 - Anaerobic
Aquatic
162-4 - Aerobic
Aquatic
or FMRA
or FAIRA
or IMRA
CD
CD
No
Yes
Yes
No
40461901
Yes
No2
No
Yes
2 Years
2 Years
2 Years
-------
Table A
Generic Data Requirenents for MZEA Acid
Data Requirement
158.290 Envncnrsnb:
WHTT.TTY STUDIES;
163-1 - Leaching
and
Adsorption/
Desorption
163-2 - \folatility
(Lab)
163-3 - \folatility
(Field)
DISSIPATION STUPTFy;
164-1 - Soil
164-2 - Aquatic
(Sediment)
164-3 - Forestry
164-4 - Coitoination
Test Use
Substance Pattern
al Fate
TGAI or PAIRA ABCD3
TEP A
TEP A
- FIELD;
TEP AB
TEP CD
TEP G
and TEP —
Does EPA
Have Data to
Satisfy This
Reouiranant?
Partially
Nb
No
Nb
Nb
Nb
—
Tlmsframe
Bibliographic Mist Additional For Data
Citation Data Be Sutnutted? Subnissicn
00146192 Yes3 1 Year
Reserved1
Reserved1
Yes 2 Years
Nb
Nb
—
Tank Mixes
164-5 - Soil, Long-Term TEP
No
Reserved'3
-------
T&ble A
Gsneric Data Requirements for fCEA Acid
Data Regptrerent
Test Use
Substance Pattern
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic Must Additional
Citation Data Be Submitted?
Timeframe
For Data
Submission
158.290
|-fll Fftfta (cont'd)
MUCTMJLATICN STUDIESi
165-1 - Rotational Crops EAIRA A
(Confined)
165-2 - Rotational Crops TEP A
(Field)
165-3 - Irrigated Crops TEP CD
165-4 - In Fish TGAI OT PAIRA ABCEG
165-5 In Aquatic
Nbntarget
TEP
158.390 - Reentry Protection
132-1 - Foliar TEP
Dissipation
132-1 - Soil Dissipation TEP
133-3 - Dermal Exposure TEP
133-4 - Inhalaticn
Exposure
TEP
EG
ABCDG
ABCEG
ABCDG
NO
Nb
Nb
ND
NO
Nb
NO
Nb
Nb
Nb
Nb
Yes
Reserved5
Nb5
Nb6
1 Year
-------
Table A
Generic Data Requirements for MIEA Acid
Does EFA
Have Data to Timef rame
Test Use Satisfy This Bibliographic Mist Additional For Data
Data Requirement Substance Pattern- Requirement? Citation
158.440 Spray Drift
202-1 Drift Field
Evaluation TEP ABCEG No No6
202-2 Droplet Size
Spectrum TEP ABCD3 No No6
158.290 Environrnental Fate; 158.390 Reentry Protection; 158.440 Spray Drift Footnotes
1'1he need for photodegradaticn. in air and laboratory/fieM volatility studies will be reassessed upon evaluation of
acceptable vapor pressure data for each chemical form of MZEA.
2Anaerobic soil data, for the M3A acid only, is satisfied by acceptable data for the anaerobic aquatic metabolism study
for the M3A acid and sodium salt. Data for all other applicable MZFA organic salt and ester forms are required for
the anaerobic aquatic metabolism study and may be substituted for the anaerobic soil metabolism study.
Additional data on both aged and unaged test substances are required with special interest paid to the mobility of the
degradates.
4May be required pending the receipt and review of data under 164-1 and 162-1.
pending the receipt and review of data under 165-4.
not exceed the toxicology criteria for data requirements. In the event that future toxLcity concerns arise, this
data requirement will be reassessed.
-------
Table A
Generic Data Requirements for M3A Sodilm Salt and Amines
Test
PaŁa. Reauirement Substance
15ft T?c
IEEKAI
161-1
K3 EhVlKHKHfl'"'^ 1 FatE
^ITCN SIUDIES-IAB-
Hydrolysis TQM
a
or EAIRA
Use
tettem-
ABCG
Does EEA
Have Data to Timef rame
Satisfy This Bibliographic PUst Additional For Data
Requirement? citation Data Be Submitted? Submission
No
Yes1
1 Year
BtotoctejradatiQn
161-2
161-3
161-4
162-1
162-2
162-3
162-4
In Water TQM
Cn Soil TQM
In Air TQM
- Aerobic Soil TQM
- Anaerobic
Soil TQM
- Anaerobic
Aquatic TQM
- Aerobic
Aquatic TQM
or EAIRA
or EAIRA
or HMRA
or FAIRA
or FAIRA
or FAIRA
or FMRA
ABOG
A
A
ABG
A
CD
CD
No
No
No
No
No
No
No
Yes1
Yes1
Reserved4
Yes1
Yes1'5
yes2,5
Yes2'5
1 Year
1 Year
2 Years
2 Years
2 Years
2 Years
-------
Table A
Generic Data Requiranents for M1& Sodium Salt and Amines
lest Use
TVrta Requirement Substance Pattem-
158.290 Ehvrixmiental Fate
I^TPIJ.TTY STUnTF*?:
163-1 - Torching
and TGAI or PAIRA. ABCDG
Adsorption/
Desorption
163-2 - Volatility TEP A
163-3 - Volatility TEP A
(Field)
DISSIPATION STUDTFS - FTTT.r>:
164-1 - Soil TEP AB
164-2 - Aquatic TEP CD
(Sediment)
164-3 - Forestry TEP G
164-4 - Combination and TEP —
Does EPA
Have Data to Timef rame
Satisfy This Bibliographic Mist Additional For Data
Requirement? Citation Data Be Submitted? Submission
Partially 00146192 Yes1'6 l Year
No Reserved1'4
No Reserved1'4
No Yes1 2 Years
No Yes2 2 Years
No Yes3 2 Years
— —
Tank Mixes
164-5 - Soil, Lang-Term TEP
AC
Reserved
-------
Table A
Generic Data Requirements for MIPA Sodium Salt and Amines
Does EPA
Have Data to
lest Use Satisfy Ihis Bibliographic Most Additional
Data Requirement Substance Pattern- Requirement? Citation Data Be Submitted?
158.290 Environmental Fate (cont'd)
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
PAIRA A Nb
TEP A Nb
TEP C Nb
165-4 - In Fish TGtf or PAIRA ABOG Nb
165-5 In Aquatic
Ncrtarget TEP G No
158.390 - Reentry Protection
132-1 - Foliar
Dissipation
132-1 - Soil Dissipation
133-3 - Dermal Exposure
133-4 - Inhalation
Exposure
IE? ABOG NO
TEP — Nb
TEP ABOG Nb
TEP ABOG Nb
Yes1
Yes1'8
Yes2
Yes1
Reserved3'9
Nb10
Kb">
Nb10
Nb10
Tiineframe
For Data
Submission
2 Years
3 Years
3 Years
1 Year
-------
Table A
Generic Data Requirements for MIA Sodiun Salt and ftnines
Data Reouirement
Test Use
Substance Pattem-
158.440 Spray Drift
202-1 Drift Field
Evaluation
202-2 Droplet Size
Spectrum.
TEP ABOG
TEP AB3G
Does EFA
Have Data to Timef rame
Satisfy This Bibliographic Mist Additional For Data
Requirement? Citation Data Be Submitted? Submission
No
No
No10
No10
oo
158.290 Environmental Fate: 158.390 Reentry Protection: 158.440 Sprav Drift Footnotes
1Data are required for the sodium salt, diethanolamine salt and the dimethylamine salt. Data on MIA acid will satisfy
requirements for the sodium salt of MIA.
2Data are required for the sodium salt and the dimethylamine salt. Data on MIA acid will satisfy the requirements for
the sodium salt of MIA.
are required for the dimethylamine salt.
need for photodegradation in air and laboratory/field volatility studies will be reassessed upon evaluation of
acceptable vapor pressure data for each chemical form of MIA.
5Anaerobic soil data, for the MIA acid only, is satisfied by acceptable data for the anaerobic aquatic metabolism study
for the MIA acid and sodium salt. Data for all other applicable MIA amines are required for the anaerobic aquatic
metabolism study and may be substituted for the anaerobic soil metabolism study.
6Additional data on both aged and unaged test substances are required with special interest paid to the mobility of the
degradates.
7May be required pending the receipt and review of data under 164-1 and 162-1.
^ield rotational crop studies are reserved pending the results of an acceptable corfined rotational crop study. No
rotational crop interval has been set in this Standard due to data gaps. Once acceptable data are available,
appropriate rotational crop intervals (if needed) will be established.
^Reserved pending the receipt and review of data under 165-4.
10Does not exceed the toxicology criteria for data requirements. In the event that future toxicity concerns arise, this
data requirement will be reassessed.
-------
liable A
Generic Data Requirements for MZEA Esters
158.290 Environmental
161-1 Hydrolysis
RTOtodegradaticn
161-2 In Water
161-3 Cn Soil
161-4 In Air
162-1 - Aerobic Soil
162-2 - Anaerobic
Soil
162-3 - Anaerobic
Aquatic
162-4 - Aerobic
Aquatic
Test Use
Substance Battem-
. Fate
AR:
TGAI or JMRA ABCDG
TGAI or EAIRA ABCDG
TGAI or IMBA. A
TGAI or IMRA A
P:
TGAI or FMRA ABG
TGAI or PMRA A
TGAI or EMRA CD
TGAI or IMRA CD
Does EEA
Have Data to
Satisfy This
Requironent?
No
No
NO
No
No
No
No
No
Bibliografiiic Must Additional
Citation Data Be Submitted?
Yes1
Yes1
Yes1
Reserved^
Yes1
Yes1'4
Yes1'4
Yes1/4
Timeframe
Rsr Data
Subrdssion
1 Year
1 Year
1 Year
2 Years
2 Years
2 Years
2 Years
-------
Table A
Generic Eata Requirements for M2E5V Esters
00
Test Use
Eata Requirement Substance Pattern-
158.290 EnyiioiiHTtal rate
163-1 - Leaching
and TQM or EMRA ABCEG
Adsorption/
Desorption
163-2 - \tolatility TEP A
(Lab)
163-3 - Vblatility TEP A
(Field)
DISSIPATION! STTIHTRS - r'|H T>:
164-1 - Soil TEP AB
164-2 - Aquatic TEP CD
Does EEA
Have Data to Timef rame
Satisfy This Bibliographic Most Additional For Eata
Requirement? Citation Eata Be Submitted? Submission
«
Partially 00146192 Yes1'5 1 Year
No Reserved1'3
No Reserved1'3
No Yes1 2 Years
No Yes2 2 Years
(Sediment)
164-3 - Forestry
164-4 - Combination and
Tank Mixes
TEP
TEP
YesJ
2 Years
164-5 - Soil, Long-Term TEP
AC
Reserved1'6
-------
Table A
Generic Data Requirenents for MIPA Enters
Test Use
Data Requirement Substance Pattem-
158.290
amivfin
165-1 -
165-2 -
165-3 -
165-4 -
165-5
158.390
132-1 -
132-1 -
133-3 -
133-4 -
EnviromiaTtal Fat
ĄITCN STUDIES:
Rotational Crops
(Confined)
Rotational Crops
(Field)
Irrigated Crops
ft (cont'd)
PAIRA A
TEP A
TCP CD
In Fish TGAI or PAIRA AECDG
In Aquatic
Nbntarget
TEP DG
Does EPA
Have Data to
Satisfy This Bibliographic Most Additional
Requirement? citation Data Be Subnitted?
No
No
No
No
No
Yes1
YesV
Yes2
Yes1
Reserved1'**
Timefrane
For Data
Submission
2 Years
3 Years
3 Years
1 Years
- Reentry Protection
Foliar
Dissipation
Soil Dissipation
Dermal Exposure
Inhalation
TEP AECDG
TCP —
TEP AECDG
TEP AECDG
Kb
No
No
No
No9
No9
No9
No9
Exposure
-------
lable A
Generic Data Requirements for MIA Esters
Data Requirement
lest
Substance
Use
Pattem-
158.440 Sprav Drift
202-1 Drift Field
Evaluation
202-2 Droplet Size
Spectrum
TEP ABCDG
TEP ABCEG
Does EFA
Have Data to
Satisfy Ihis
Requirement?
Timeframe
Bibliographic Mist Additional For Data
Citation Data Be Submitted? Submission
No
No
No9
No9
•CD
158.290 Environment]
158.
Protectic
Sprav Dri-
are required for the buboxyethyl ester and the isocctyl ester derivatives.
2Data are required for the isooctyl ester.
•^Dre need for photcdegradaticn in air and laboratory/fieM volatility studies will be reassessed upon evaluation of
acceptable vapor pressure data for each chemical form of MIA.
'^aerobic soil data, for the MIA acid only, is satisfied by acceptable data for the anaerobic aquatic metabolism study
for the MIA acid and sodium salt. Data for all other applicable MIA organic salt and ester forms are required for
the anaerobic aquatic metabolism study and may be substituted for the anaerobic soil metabolism study.
5Mditional data on both aged and unaged test substances are required with special interest paid to the mobility of the
degradates.
kffey be required pending the receipt and review of data under 164-1 and 162-1.
7FieM rotational crop studies are reserved pending the results of an acceptable confined rotational crop study. ND
rotational crop interval has been set in this Standard due to data gaps. Orce acceptable data are available,
appropriate rotational crop intervals (if needed) will be established.
8Reserved pending the receipt and review of data under 165-4.
^oes not exceed the toxicology criteria for data requirements. In the event that future toxicity concerns arise, this
data requirement will be reassessed.
-------
Table A
MCPA Acid Generic Data Requirements
Data Requirement
Test
Substance
Use
Pattern
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic Must Additional
Citation Data Be Submitted?
Timeframe
For Data
Submission
oo
S158.490 - Wildlife and
AVIAN AND MAMMALIAN TESTING
71-1 - Avian Oral ID50 TGAI
71-2 - Avian Dietary LCso
a. Upland Game TGAI
Bird
b. Waterfowl TGAI
71-3 - Wild Mammal TGAI
Toxicity
71-4 - Avian Reproduction TGAI
71-5 - Simulated and TEP
Actual Testing
for Birds and
Mammals
B
B
B
B
B
B
Yes
Yes
Yes
NO
NO
NO
40019201
00163844
00163844
NO
NO
NO
NO
Yes
Reserved1
2 Years
-------
CO
Table A
M3PA Acid Generic Data
Requirements
Data
S158.
Test
Requirement Substance
Use
Pattern
Does EPA
Have Data to
Satisfy This
Recaii rement ?
Must Additional
Data Be Submitted Timef rame
Bibliographic Under FIFRA Section For Data
Citation 3(c)(2)(B)? Submission
,490 - Wildlife and Aouatic Organisms (cont'd)
AQUATIC ORGANISM TESTING
72-1
72-2
72-3
72-4
72-5
72-6
- Freshwater Fish LC50
a. Coldwater
b. Warmwater
- Freshwater Aquatic
Invertebrate LCso
- Estuarine/Marine
Organism LC5o
- Fish Early Life Stage/
Aquatic Invertebrate
Life Cycle
- Fish Life Cycle
- Aquatic Organism
TGAI
TEP
TGAI
TEP
TGAI
TEP
TGAI
TEP
TGAI
TGAI
TGAI
B
B
B
B
B
B
B
B
B
B
B
Yes
No
Yes
No
Yes
NO
Partially
No
NO
NO
NO
00041294,00041295, No
00029654
NO2
00041294,00041295, No
00029654
NO2
00041294,00041295, No
00029654
NO
40062002,40062003 Yes6 1 Year
NO2
Reserved3
Reserved4
Yes 1 Year
Accumulation
72-7 - Simulated or Actual
Field Testing -
Aquatic Organisms
TEP
B
NO
Reserved-
-------
Table A
MZEA Acid Generic Data Requirements
Data Requirement
Test Use
Substance Pattern
Does EPA
Have Data to
Satisfy This
Requirement?
Must Additional
Data Be Sutmitted Timef rame
Bibliographic Under FTFRA Section For Data
Citation 3(c)(2HB)? Submission
oo
s158.540 Plant Protection
121-1 - TARGET AREA TEP B
PHYTOTCKICITY
NGNTARGET AREA PHYTOTQXICITY
TIER I
121-1 - Seed Germination/ TGAI B
Seedling Emergence
122-1 - Vegetative Vigor TGAI B
122-2 - Aquatic Plant Growth TGAI B
TIER II
123-1 - Seed Germination/ TGAI B
Seedling Emergence
123-1 - Vegetative Vigor TGAI B
123-2 - Aquatic Plant Growth TGAI B
TIER III
124-2 - Terrestrial Field
Study TEP B
124-2 - Aquatic Field Study TEP B
NO
NO
No
NO
No
NO
NO
No
No
NO
No
Yes
Yes
Yes
Reserved5
Reserved5
1 Year
1 Year
1 Year
-------
Table A
MCEA. Acid Generic Data Requirements
158.490 - 540 Footnotes
1Reserved pending receipt and evaluation of environmental fate studies.
2Fornulated product testing is not required because this pesticide has no aquatic uses and the maximum estimated
envircnmaTtal ccrcentration is not greater than the lowest 1^50-
Reserved pending receipt and evaluation of acute toxlcity and environmental fate studies.
^Reserved pending receipt and evaluaticn of fish early life stage or invertebrate life cycle studies, if required.
Reserved pending receipt and evaluation of Tier II plant studies.
6Guidelines requirement for 48-hour IŁ5Q for shrimp not fulfilled.
CD
-------
Table A
Generic Data Requirements for Organic Amines/Esters of MCPA
Data
5158.
Test
Requirement Substance
Use
Pattern
490 - Wildlife and Acruatic Oraanisms
AVIAN AND MAMMALIAN TESTING
71-1
71-2
71-3
71-4
71-5
- Avian Oral LD50
- Avian Dietary LC50
a. Upland Game
Bird
b. Waterfowl
- Wild Mammal
Toxicity
- Avian Reproduction
- Simulated and
Actual Field
Testing - Mammals
and Birds
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A,B,C,G
A,B,C,G
A,B,C,G
A,B,C,G
A,B,C,G
A,B,C,G
Does EPA
Have Data to
Satisfy This Bibliographic Must Additional
Reouirement? Citation Data Be Submitted?
No
No
No
No
No
No
Yes
Yes
Yes
NO
Reserved1
Reserved^
Timeframe
For Data
Submission
1 Year
1 Year
1 Year
AQUATIC ORGANISM TESTING
72-1
72-2
- Freshwater Fish LC50
a. Coldwater
b. Warmwater
- Freshwater Aquatic
Invertebrate LCcn
TGAI
TEP
TGAI
TEP
TGAI
TEP
A,B,C,G
C
A,B,C,G
C
A,B,C,G
C
Partially 40062005
Partially 00041298,00026928,
00041297,00041299
NO
Partially 00041298,00026928,
00041297,00041299
NO
No
x^o
Yes6
Yes
Yes6
Yes
Yes
1 Year
l Year
1 Year
1 Year
1 Year
1 Year
-------
Table A
Generic Data Requirements for Organic Amines/Esters of MCEA
Test
Data Requirement Substance
Use
Pattern
Does EPA
Have Data to
Satisfy This
Reoui rement ?
Timeframe
Bibliographic Must Additional For Data
Citation Data Be Submitted? Submission
§158.490 - Wildlife and Aquatic Orqanisms (cont'd)
AQUATIC ORGANISM TESTING (cont'd)
OO
OO
72-3 - Estuarine/Marine
Organism LCso
72-4 - Fish Early Life Stage/
Aquatic Invertebrate
Life Cycle
72-5 - Fish Life Cycle
72-6 - Aquatic Organism
TGAI
TEP
TGAI
TGAI
TGAI
A,C,G
c
A,C,G
A,C,G
A,C,G
No
No
No
No
No
Yes
Yes
Reserved2
Reserved-^
Yes
1 Year
1 Year
1 Year
Accumulation
72-7 - Simulated or Actual TEP A,C,G
Field Testing -
Aquatic Organisms
5158.540 Plant Protection
121-1 - TARGET AREA TEP A,C,G
PHYTOTOXICITY
NO
NO
Reserved"1
-------
Table A
Generic Data Requirements for Organic Amines/Esters of MCPA
oo
Does EPA
Have Data to Timeframe
Test Use Satisfy This Bibliographic Must Additional For Data
Data Rponirempjit Substance Pattern Reouirement? Citation Data Be Submitted? Submission
NCMIM
121-1
122-1
122-2
123-1
123-1
123-2
124-1
124-2
ŁET AREA PHYTOTOKICITY
TIER I
- Seed Germination/ TGAI A,C,G No
Seedling Emergence
- Vegetative Vigor TGAI A,C,G No
- Aquatic Plant Growth TGAI A,C,G No
TIER II
- Seed Germination/ TGAI A,C,G No
Seedling Emergence
- Vegetative Vigor TGAI A,C,G No
- Aquatic Plant Growth TGAI A,C,G No
TIER III
- Terrestrial Field
Study TEP A,C,G No
- Aquatic Field Study TEP A,C,G No
No
No
No
Yes 1 Year
Yes 1 Year
Yes 1 Year
Reserved4
Reserved5
-------
Table A
Generic Data Requirements for Organic Amines/Esters of MCPA
158.490 - 540 Footnotes
•'•Reserved pending receipt and evaluation of environmental fate studies.
2Reserved pending receipt and evaluation of acute toxicity and environmental fate studies.
3Reserved pending receipt and evaluation of fish early life-stage of invertebrate life-cycle studies, if required.
^Reserved pending receipt and evaluation of Tier II plant studies.
SA rainbow trout study using 56.4% technical dimethylamine salt was submitted and found acceptable.
6Data are available to support 52% dimethylamine salt formulation for coldwater and warmwater fish.
o
-------
Table A
MCPA Sodium Salt Generic Data Requirements
Does EPA
Have Data to
Test Use Satisfy This Bibliographic
Data Reouirement Substance Pattern Reouirement? Citation
§158.490 - Wildlife and Aquatic Organisms
Timeframe
Must Additional For Data
Data Be Submitted? Submission
AVIAN AND MAMMALIAN TESTING
71-1 - Avian Oral ID50
71-2 - Avian Dietary IŁ$Q
a. Upland Game
Bird
b. Waterfowl
71-3 - Wild Mammal
Toxic ity
71-4 - Avian Reproduction
71-5 - Simulated and
TGAI A,B,C Yes 40019201
TGAI A,B,C Yes 00163844
TGAI A,B,C Yes 00163844
TGAI A,B,C No
TGAI A,B,C No
TEP A,B,C No
No
No
No
No
Reserved1
Reserved2
Actual Field
Testing - Mammals
and Birds
AQUATIC ORGANISM TESTING
72-1 - Freshwater Fish LC50
a. Coldwater
b. Warmwater
TGAI
TEP
TGAI
A,B,C
C
A,B,C
Yes
Yes
Yes
Yes
00041294,00041295, No
00029654
00004512,00026927 Yes-
00041300,00029655
00041294,00041295, No
00029654
00004512,00026927 Yes:
1 Year
1 Year
-------
Table A
M3PA Sodium Salt Generic Requirements (cont'd)
Data
5158
Test
Requirement Substance
.490 - Wildlife and Aouatic Oraani
AQUATIC ORGANISM TESTING (cont
72-2
72-3
72-4
72-5
72-6
- Freshwater Aquatic
Invertebrate LC5o
- Estuarine/Marine
Organism LC50
- Fish Early Life Stage/
Aquatic Invertebrate
Life Cycle
- Fish Life Cycle
- Aquatic Organism
fd)
TGAI
TEP
TGAI
TEP
TGAI
TGAI
TGAI
Use
Pattern
sms
A
C
A
C
A
A
A
(cont'
,B,C
,B,C
,B,C
,B,C
,B,C
Does EPA
Have Data to
Satisfy This
Requirement?
d,
Yes
No
Partially
No
No
No
No
Bibliographic Must Additional
Citation Data Be Submitted?
00041294,00041295, No
00029654
Yes3
40062002,40062003 Yes6
Yes3
Reserved2
Reserved4
Yes
Timeframe
For Data
Submission
1 Year
1 Year
1 Year
1 Year
Accumulation
72-7 - Simulated or Actual TEP A,B,C
Field Testing -
Aquatic Organisms
S158.540 Plant Protection
121-1 - TARGET AREA TEP A,B,C
PHYTOTOXICITY
NO
Reserved^
No
No
-------
Table A
ICFA Sodium Salt Generic Data Requirements (cont'd)
Data Requirement
Test Use
Substance Pattern
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic Must Additional
S158.540 Plant Protection
NCNIARGET AREA PHYTOICKICrTY
TIER I
121-1 - Seed Germination/
TGAI A,B,C
Seedling Bnergence
122-1 - Vegetative Vigor TGAI A,B,C
122-2 - Aquatic Plant Growth TGAI A,B,C
TIER II
123-1 - Seed Germination/
TGAI A,B,C
Seedling Emergence
123-1 - Vegetative Vigor TGAI A,B,C
123-2 - Aquatic Plant Growth TGAI A,B,C
TIER III
124-1 - Terrestrial Field
Study TEP A,B,C
124-2 - Aquatic Field Study TEP A,B,C
No
No
No
No
No
No
No
No
No
Yes
Yes
Yes
No
No
Reserved
Reserved
Timeframe
For Data
Submission
l Year
1 Year
1 Year
-------
Table A
M3PA Sodium Salt Generic Data Requirements (cont'd)
158.490 - 540 Footnotes - (cont'd)
•^This study is required for technical M3PA. acid and that study will support this requirement.
2Reserved pending receipt and evaluation of acute toxicity and environmental fate studies.
^Formulated product testing is required because this pesticide has aquatic uses.
Reserved pending receipt and evaluation of fish early life-stage or invertebrate life-cycle studies, if required.
5Reserved pending receipt and evaluation of Tier II plant studies.
6Guideline requirement for 48-hour LC50 for shrimp (using technical M3PA. acid) is not fulfilled.
-------
Table A
Generic Data Requirements for M3PA, Dimethylamine Salt
Data Requirement
Test
Substance
Use
Pattern
Does EPA
Have Data to
Satisfy This
Requirement?
Most Additional
Data Be Submitted Timeframe
Bibliographic Under FIERA Section For Data
Citation 3(c)(2)(B)? Submission
158.590 - Nontaraet Insects
NQNIARGET INSECT TESTING - POLLINATORS
141-1 - Honey Bee Acute
1^50
TGAI
141-2 - Honey Bee -
Toxicity TEP
of Residues on
Foliage
141-5 - Field Testing TEP
For Pollinators
A,B,G
A,B,G
A,B,G
NO
No
No
Yes
NoJ
NoJ
1 Year
-'-Requirement deferred pending evaluation of data from the acute contact test.
-------
Table A
Generic Data Requirements for IVCPA, Isooctyl Ester
Data Requirement
Test
Substance
Use
Pattern
Does EPA
Have Data to
Satisfy This
Requirement?
Must Additional
Data Be Submitted Timeframe
Bibliographic Under FIFRA Section For Data
Citation 3(c)(2)(B)? Submission
158.590 - Nbntaraet Insects
NCKflARGET INSECT TESTING - POLLINA.r
141-1 - Honey Bee Acute TGAI A,B,G
Toxicity
141-2 - Honey Bee -
Toxicity TEP A,B,G
of Residues on
Foliage
141-5 - Field Testing for TEP A,B,G
Pollinators
No
No
No
Yes
N6J
NbJ
1 Year
ON
•^Requirement deferred pending evaluation of data from the acute contact test.
-------
Table B
Product Specific Data Requirements for MCPA, Manufacturing-Use Products
Data Requirement
Test
Substance
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(cH2HB)?
Timeframe
For Data
Submission
158.190 Product Chemistry
Product Identity and Composition
61-1 - Product Identity and
Disclosure of
Ingredients
MP
61-2 - Description of Beginning MP
Materials and Manu-
facturing Process
61-3 - Discussion of Formation
of Impurities
MP
No
Mb
NO
Analysis and Certification of Product Ingredients
62-1 - Preliminary Analysis MP No
of Product Samples
62-2 - Certification of
Ingredient Limits
MP
62-3 - Analytical Methods to MP
Verify Certified Limits
No
No
00159470,00154076,
00155743,00126755,
00155233
N/A
N/A
N/A
00126755,00155233,
00154076,00159470,
00155743
00158078
00154076
00154064
00126755
00155234
00105215
00094623
,00159470,
,40212901,
,40513001,
,00155743,
,40314402,
,00079473,
Yes
Yes
Yes
Yes-
Yes-
Yes1
1 Year
1 Year
1 Year
1 Year
1 Year
1 Year
-------
Table B
Product Specific Data Requirements for MCPA, Manufacturing-Use Products
CO
Data
Test
Reouirement Substance
Does EPA Must Additional
Have Data to Data Be Submitted Timeframe
Satisfy This Bibliographic Under FIFRA Section For Data
Reouirement? Citation 3(c)(2)(B)? Submission
158.190 - Product Chemistry (cont'd)
Physical and Chemical Characteristics
63-2
63-3
63-4
63-7
63-12
- Color
- Physical State
- Odor
- Density, Bulk Density or
Specific Gravity
- pH
62-14 - Oxidizing or
Reducing Action
62-15
63-16
63-17
63-18
63-19
- Flammability
- Explodability
- Storage Stability
- Viscosity
- Miscibility
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
No
No
No
No
No
No
No
No
No
No
No
Yes7
Yes7
Yes7
Yes7
Yes7'8
00155743,00152836 Yes7
00155743,00159470, Yes7'9
00152836
00155743,00126755, Yes7,10
00152836
00155743,00159470 Yes7
00126755,00152836
Yes7'11
00126755 Yes7'12
1 Year
l Year
1 Year
1 Year
1 Year
1 Year
1 Year
1 Year
2 Years
1 Year
1 Year
-------
Table B
Product Specific Data Requirements for MCPA, Manufacturing-Use Products
Does EPA Must Additional
Have Data to Data Be Submitted Timeframe
Test Satisfy This Bibliographic Under FIFRA Section For Data
lirement _ Substance _ Requirement? _ Citation _ 3(c) (2) (B)? _ Submission
Part 158.190 - Product Chemistry - (cont'd)
Physical and Chemical Characteristics (cont'd)
63-20 - Corrosion MP No 00155743,00159470 Yes7 2 Years
Characteristics 00152836
Other Requirements
64-1 - Submittal of Samples N/A N/A N/A No
158.190 Footnotes - All numbers in parentheses refer to EPA registration numbers.
regarding this topic is required for all nenufacturing^use products except the Riverdale 94 percent T acid(228-
200) and the 91 percent T isooctyl ester (228-198) , and the BASF 93.6 percent T acid alternate formulation (7969-34) .
The requirements may be satisfied by selected information for the following products: (i) Upper and lower certified
limits must be provided for the active ingredient and upper limits for each impurity or group of impurities for which a
certified limit is required for products with EfA Registration Numbers listed parenthetically: the Rhone-BDulenc 92
percent (359-728) and 98 percent (359-721) T acids, and the 97 percent T butoxyethyr ester (359-738) ; the Kanisk Vaerk
Koge A/S 95 percent T acid (EfA Reg. No. 11636-2) ; the A.H. Marks 93 percent T acids (15440-7 and -18) , the 94.3 percent
butoxyethyl ester (15440-8) , and the 94 percent T isooctyl ester (15440-9) ; the Gilmore 95 percent T acid (42545-19) ,
the 94 percent T isooctylester (42545-24 - basic fonrulation) ; and the Dow 64 percent Fl dimethylamine salt (464-582) ,
the 93.3 percent T butoxyethyl ester (464-595) , and the 93.3 percent T isooctyl ester (464-585). Certifications must be
submitted on EEA form 8570-4 (Rev. 2-85) for these products and for the: Gilmore 94 percent T isooctyl ester-alternate
formulation (42545-24) and the 95 percent T acid (42545-9) ; the Dew 94 percent T acid (464-580) ; and the Kanisk Vaerk
Kbge A/S 92 percent T isooctyl ester (11636-3) . (ii) Nominal concentrations are required for: the Dow 94 percent T
acid (464-580) ; the EBI/Gordon 45.5 percent FI; the BASF 93.6 percent TR acid basic formulation (7969-34) ; and the
Kanisk Vaerk Kbge A/S 92 percent T isooctyl ester (EEA Reg. No. 11636-3) . (iii) An updated CSF must be submitted for:
the Rhone-RxiLenc 92 percent (359-728) and 98 percent (359-721) Ts acids; the Marks 93 percent T acid (15440-18) ; the
Gilmore 95 percent T acid (42545-19) and 94 percent T isooctyl ester basic formulation (42545-24) by the current
registrant; (iv) The purpose of ingredients is required of all of the A.H. Marks technical products (15440-7, -18, -8,
-------
Table B
Product ^ecif ic Data Requirements for MZPA, Manufacttiring-Use Products
158.190 Ebotnotes
-9). (vi) Gonpounds present as a consequence of reactions of the nemfacturing process must be listed as impurities
rather than inerts on the CSFs for the following products: Karu.sk Vaerk Kbge A/S 95 percent T acid (11636-2); Gilmore
95 percent T acids (42545-9 and 42545-19), and the 94 percent T isooctyl ester (42545-24); the Rhone-Rxilenc 97 percent
butoxyethyl ester (359-738); the Dow 93 percent T isooctyl ester (464-585); and the 93 percent T butoxethyl ester (464-
595).
^complete information nust be provided for the Dow 64 percent FT (464-582), the FBI/Gordon 45.5 percent FT (2217-722),
the Dow 64 percent FI (464-582), the Denbro 74.38 percent FI (51907-20), the Inter-Ag 97 percent FI (57539-43), and the
Platte 95 percent (34704-232) regarding the nature of the process (batch or continuous), the relative amounts of
beginning materials and the order in \vhich they are added, the 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.
•?A detailed discussion must be submitted for PBI/Gordon 45.5 percent FI (2217-722), the Dow 64 percent FI (464-582), the
^ Denbro 74.38 percent FI (51907-20), the Inter-Ag 97 percent (57539-43), and the Platte 95 percent FI (34704-232)
O regarding all impurities that are or may be present at > 0.1 percent, based on knowledge of the beginning materials,
O intencted and side chemical reactions in the itHnufacturing process, and any contamination during and after production.
A decision regarding the possible presence of dibenzo-p^dioxins, and dibenzofurans from any source in the product is
also required. In addition, a discussion of the possible formation of nitrosamines is required for the 64 percent and
74.38 percent FI dimethylamine salts (464-582 and 51907-20).
^ive or more representative samples of the PBI/Gordon 45.5 percent FI, the Daw 64 percent FI dimethylamine salt (464-
582), the Denbro 74.38 percent FI dimethylamine salt (51907-20), the Inter-Ag 97 percent FI (57539-43), and the Platte
95 percent FI mixed ester (34704-232) must be analyzed for the amount of active ingredient and each impurity for which
certified limits are required. Complete, detailed descriptions of the analytical methods used must be submitted along
with statements of their precisian 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 relative
standard deviation of reported analytical results. In addition, six samples of the Dew and Daibro FI dimethylamine
salt products must be analyzed for presence of nitrosamines by methods capable of detecting 1 ppm.: two samples must be
analyzed shortly after production, two samples at 3 months after production, and tuo samples at 6 months after
production.
5Upper and lower limits for the active ingredient and each intentionally added inert, and upper limits for each impurity
present at > 0.1 percent (w/W, and each additional '^toxicologically significant" impurity present at < 0.1 percent
(w/w) must be provided and certified. An explanation of how each certified limit was established must be provided
(e.g., sample analysis using validated analytical procedures, quantitative estimate based on amount of
-------
Table B
Product pacific Data Requirements for M3&, Manofacturing-Use Products
158.190 Footnotes (cont'd)
considered to be of toxicological significance, regardless of the concentration at which they occur. Certifications
nust be submitted on EEA Form 8570 (Rev. 2-85). These data are required for all itHnufacturing-use products except the
Riverdale 94 percent T acid (228-200), and the 91 percent T iscoctyl ester (200-198), and the HkSF 93.6 percent T acid
alternate formulation (7969-34). The requirements may be satisfied for the following products by submission of
validation data for precision and accuracy for the analytical methods used to verify certified limits: the Dow 94
percent T acid (EIA Reg. No. 464-580), the Gilmore 95 percent T acid (EFA Reg. No. 42545-9), and the Kemisk Vaerk Koge
A/S 92 percent T iscoctyl ester (Em Reg. No. 11636-3).
6Analytical methods to determine the active ingredient and each inpurity (iirluding dibenzo-p-dioxins and
dibenzofurans) and intentionally added inerts for vMch a certified limit is required must be submitted for all
manufacturing-use products except the Riverdale 94 percent T acid (228-200) and 91 percent T iscoctyl ester (228-198),
and the EftSF 93.5 percent T alternate formulation (7969-34). This requirement may be satisfied for the following
products by submission of validated methods for additional impurities and validation studies depicting precision and
accuracy of the available methods for active ingredient and impurities: the Rhone-Poulenc unspecified T acid; the Dow
—» T acid (464-580), FI dimethylamine salt (464-582), and T iscoctyl ester (464-585); the EftSF T acid (7969-34); the
>O Kemisk T acid 911636-2); an unspecified fferks T acid and esters; and the Gilmore T acid basic fQntiii.at.icn (42545-9).
—* I^fethods for quantification, of nitrosamines are also required for the 64 percent and 74.38 percent FI dimethylamine
salts (Em Reg. Nos. 464-582 and 51907-20). Each method must be accompanied by validation studies indicating its
accuracy and precision. These methods must be suitable for enforcement of certified limits.
7As required in the 40 CFR 158.120 and more fully described in the Pesticide Assessment Guidelines, Subdivision D,
quantitative data regarding color, physical state, odor, specific gravity, pH, oxidizing/reducing action,
flammability, explodability, storage stability, viscosity, irascibility, and corrosion characteristics for each
manufacturing-use product except the Riverdale 94 percent T acid (228-200) and 91 percent T iscoctyl ester (228-189),
the EftSF 93.6 percent T acid alternate formulation (11636-34), and the technical products for which certain of these
data were requested in footnote 4 in Table A - Product Chemistry.
%ata on pH are required if the test substance can be diluted or dispersed in water.
^Data are required on the flashpoint if the product is or contains a combustible liquid.
10Data are required if the product contains any potentially explosive ingredients.
•^Data on viscosity are required if the product is a liquid.
12Data on miscibility are required if the product is an enulsifiable liquid and is to be diluted with petroleum
solvents.
-------
Table B
Product-Specific Data Requirements for MCPA, Manufacturing-Use Products
Data Requirement
158.340 - Toxicology
ACUTE TESTING
81-1 - Acute Oral - Rat
81-2 - Acute Dermal
81-3 - Acute Inhalation - Rat
81-4 - Primary Eye Irritation -
Test
Substance
MP
MP
MP
MP
Does EPA
Have Data to
Satisfy This
Requirement?
No
No
No
No
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2HB)?
Yes
Yes
Yes
Yes
Timeframe
For Data
Submission
2 Years
2 Years
2 Years
1 Year
o
Rabbit
81-5 - Primary Dermal
Irritation
MP
No
Yes
1 Year
81-6 - Dermal Sensitization
MP
No
Yes
1 Year
-------
Table C
Product Specific Data Requirements for MCPA - End-Use Products
Data Requirement
Test Use
Substance Patterns
Must Additional Timeframe
Does EPA1 Bibliographic Data Be2 for
Have Data? Citation Submitted? Submission
40 CFR S158.155-190 Product Chemistry
Product Composition
61-1. Product Composition EP
61-2. Beginning Materials EP
Production or Formulation Process
61-3. Formation of Impurities EP
Analysis and Certification of Product Ingredients
EP
EP
EP
^ 62-1. Preliminary Analysis
O
O^ 62-2. Certified Limits
62-3. Enforcement Analytical
Methods
TED
TED
TED
TED
TED
Yes
Yes
Yes
Yes
Yes
Yes
l Year
1 Year
1 Year
1 Year
1 Year
1 Year
-------
Table C
Product Specific Data Requirements for MCPA - End-Use Products
Data Requirement
Physical and Chemical Character:
63-2.
63-3.
63-4.
63-7.
63-12.
62-14.
62-15.
63-16.
63-17.
Color
Physical State
Odor
Density, Bulk Density,
or Specific Gravity
pH
Oxidizing or Reducing
Action
Flammability
Explodability
Storage Stability
Test
Substance
Lstics
EP
EP
EP
EP
EP
EP
EP
EP
EP
Must Additional Timeframe
Use Does EPA Bibliographic Data Be for
Patterns Have Data? Citation Submitted? Submission
TBD
TBD
TBD
TBD
TBD
TBD
TBD
' TBD
TBD
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
1 Year
1 Year
1 Year
1 Year
1 Year
1 Year
1 Year
1 Year
2 Years
-------
Table C
Product Specific Data Requirements for M3PA - End-Use Products
Data Requirement
Test Use Does EPA Bibliographic
Substance Patterns Have Data? Citation
Must Additional Timeframe
Data Be for
Submitted? Submission
Physical and Chemical Characteristics (Continued)
63-18. Viscosity EP
63-19. Miscibility EP
63-20. Corrosion Characteristics EP
Other Requirements;
64-1. Submittal of Samples N/A
TBD
TBD
TBD
N/A
N/A
Yes
Yes
Yes
NO
1 Year
1 Year
2 Years
CD
Ul
^-Registrants must inform the Agency whether acceptable data are available on each of their end-use products.
Registrants may cite data which the Agency has previously informed them are acceptable or data which they believe
to be acceptable. While the Agency makes the final determination of what constitutes "acceptable" data, guidance
is offered in 40 CFR 158.80. In addition, 40 CFR 158.108 announces the avialability of guidelines for conducting
acceptable tests. If acceptable data are available, registrants must cite the MRID or accession numbers; if
acceptable data are not available, registrants must submit data within the time frames listed on this table.
2See above footnote.
3TBD=To be determined.
-------
Table C
Product Specific Data Requirements for MCPA - End-Use Products
Must Additional Timeframe
Test Use Does EPA Bibliographic Data Be for
Data Requirement Substance Patterns Have Data? Citation Submitted? submission
J°58.340 Toxicoloov - Acute Testinq:
81-1
81-2
81-3
81-4
81-5
81-6
- Acute Oral-Rat EP A,B
- Acute Dermal EP A,B
- Acute Inhalation-Rat EP A,B
- Eye Irritation-Rabbit EP A,B
- Dermal Irritation-Rabbit EP A,B
- Dermal Sensitization -
Guinea Pig EP A,B
TBD3
TBD
TBD
TBD
TBD
TBD
Yes
Yes
Yes
Yes
Yes
Yes
2 Years
2 Years
2 Years
1 Year
1 Year
1 Year
81-7 - Acute Delayed
Neurotoxic ity-Hen
EP
A,B
No-
-'•Registrants must inform the Agency whether acceptable data are available on each of their end-use products.
Registrants may cite data which the Agency has previously informed them are acceptable or data which they believe
to be acceptable. While the Agency makes the final determination of what constitutes "acceptable" data, guidance
is offered in 40 CFR 158.108. In addition, 40 CFR 158.108 announces the avialability of guidelines for
conducting acceptable tests. If acceptable data are available, registrants must cite the MRID or accession
numbers; if acceptable data are not avialable, registrants must submit data within the time frames listed above.
2See above footnote.
3TBD = To be determined.
4An acute neurotoxicity study is not required since MCPA is not an organophosphate.
-------
II. LABELING APPENDICES
107
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SUMMARY-1
LABEL CONTENTS
40 CFR 156.10 requires that certain specific labeling
statements appear at certain locations on the label. This is
referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will not
be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address of
the registrant or distributor is required on the label. The
name and address should preferably be located at the bottom of
the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is required
on all labels or on the container of the pesticide. The
preferred location is the bottom of the front panel immediately
above the company name and address, or at the end of the label
test. The net contents must be expressed in the largest
suitable unit, e.g., "1 pound 10 ounces" rather than "26
ounces." In addition to English units, net contents may be
expressed in metric units. [40 CFR 156.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration number
assigned to the pesticide product must appear on the label,
preceded by the phrase "EPA Registration No.," or "EPA Reg. No."
The registration number must be set in type of a size and style
similar to other print on that part of the label on which it
appears and must run parallel to it. The registration number
and the required identifying phrase must not appear in such a
manner as to suggest or imply recommendation or endorsement of
the product by the Agency. [40 CFR 156.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final
establishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of the
package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or
container. [40 CFR 156.10(f)]
108
-------
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)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING, or
CAUTION) is required on the front panel immediately below the
child hazard warning statement.
[40CFR 156.10(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)(1)(iii)]
109
-------
SUMMARY-3
Item 7E. REFERRAL STATEMENT - The statement "see Side (or
Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR 156.10(h)(1)(iii)].
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together on
the label under the heading "PRECAUTIONARY STATEMENTS." The
preferred location is at the top of the side or back panel
preceding the directions for use, and it is preferred that
these statements be surrounded by a block outline. Each of the
three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR 156.10(h)(2)]
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR 156.10(h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of the
hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 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 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that all pesticide formulations/uses be classified for
either general or restricted use. Products classified for
restricted use may be limited to use by certified applicators or
persons under their direct supervision (or may be subject to
other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
11Q
-------
SUMMARY-4 -
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified for
restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During the
Agency's review of your application, your proposed
classification determination will be evaluated in accordance
with the provisions of 40 CFR 162.11(c). You will be notified
of the Agency's classification decision.
Classification Labeling Requirements
if your product has been classified for restricted use, the
following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label.
The statement must be set in type of the same
minimum size as required for human hazard signal
word (see table in 40 CFR 156.10(h)(1)(iv).
b. Directly below this statement on the front
panel, a summary statement of the terms of
restriction must appear (including the reasons for
restriction if specified in Section I). If use is
restricted to certified applicators, the following
statement is required: "For retail sale to and use
only by Certified Applicators or persons under
their direct supervision and only for those uses
covered by the Certified Applicator's
Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified for
restricted use, and some are unclassified, several courses of
action are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label uses
that are unrestricted, but you may not distinguish
them on the label as being unrestricted.
111
-------
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.
1 12
-------
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 unreasonabl'e 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.
1 13
-------
SUMMARY-7
LABELING
OF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEEJ ELFMPYT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warnina)
Signal word
APPLICABILITY
OF REOUTREMEOT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage is
given as Ibs.
ai/unit area
All products
All products
All products
PLftTEMENT <~W LARFTj
REOJIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
nanel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel
imnediately
before or
following
Rea. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warnina
COWEOTS
If registrant is not the producer, must
be qualified by "Packed for . . . ,"
"Distributed by . . . ." etc.
May be in metric units in addition to
U.S. units.
Must be in similar type size and run
parallel tQ other type,
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
-------
SUMMARY-8
LABELING REQUIREMENTS OF THE FIFRA. AS AMENDED (cont'd)
ITEM
1C
7D
7E
8
8A
SB
LABJTr EfiFMENT
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
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel
All products
All products
in Categories
I, II, and III
All products
PLACEMENT
REQUIRED
Front panel
Category I;
Front panel
unless refer-
ral statement
is used.
Others;
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None
DM 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
CdfiENTS
•
Must be grouped under headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
-------
SUM^ARY-9
(cont'd)
ITEM
8C
9A
9B
10A
10B
IOC
LAB^T. FJ'TOffTTT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°*-
All restricted
products
All products
PR Notice 83-2
or as determined
by the Aaency
All products
All products
PLACEMENT
REDUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
CN IABEL
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
CC^MENT??
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
sicmal 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,
CCNT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
-------
Chapter I—Environmental Protection-Agency
§156.10 Labeling Requirements for Pesticides and Devices.
(a) General—(1) Contents of the label. Every pesticide
product shall bear a label containing the information specified
by the Act and the regulations in this Part. The contents of a
label must show clearly and prominently the following:
(i) The name, brand, or trademark under which the product is
sold as prescribed in paragraph (b) of this section;
(ii) The name and address of the producer, registrant, or
person for whom produced as prescribed in paragraph (c) of this
section;
(iii) The net contents as prescribed in paragraph (d) of this
section;
(iv) The product registration number as prescribed in
paragraph (e) of this section;
(v) The producing establishment number as prescribed in
paragraph (f) of this section;
(vi) An ingredient statement as prescribed in paragraph (g) of
this section;
(vii) Warning or precautionary statements as prescribed in
paragraph (h) of this section;
(viii) The directions for use as prescribed in paragraph (i)
of this section; and
(ix) The use classification(s) as prescribed in paragraph (j)
of this section.
(2) Prominence and legibility. (i) All words, statements,
graphic representations, designs or other information required on
the labeling by the Act or the regulations in this part must be
clearly legible to a person with normal vision, and must be
placed with such conspicuousness (as compared with other words,
statements, designs, or graphic matter on the labeling) and
expressed in such terms as to render it likely to be read and
understood by the ordinary individual under customary conditions
of purchase and use.
(ii) All required label text must:
(A) Be set in 6-point or larger type;
(B) Appear on a clear contrasting background; and
(C) Not be obscured or crowded.
(3) Language to be used. All required label or labeling text
shall appear in the English language. However, the Agency may
require or the applicant may propose additional text in other
languages as is considered necessary to protect the public. When
additional text in another language is necessary, all labeling
requirements will be applied equally to both the English and
other-language versions of the labeling.
(4) Placement of Label—(i) General. The label shall appear
on or be securely attached to the immediate container of the
117
-------
pesticide product. For purposes of this Section, and the
misbranding provisions of the Act, "securely attached" shall mean
that a label can reasonably be expected to remain affixed during
the foreseeable conditions and period of use. If the immediate
container is enclosed within a wrapper or outside container
through which the label cannot be clearly read, the label must
also be securely attached to such outside wrapper or container,
if it is a part of the package as customarily distributed or
sold.
(ii) Tank cars and other bulk containers—(A) Transportation.
While a pesticide product is in transit, the appropriate
provisions of 49 CFR Parts 170-189, concerning the transportation
of hazardous materials, and specifically those provisions
concerning the labeling, marking and placarding of hazardous
materials and the vehicles carrying them, define the basic
Federal requirements. In addition, when any registered pesticide
product is transported in a tank car, tank truck or other mobile
or portable bulk container, a copy of the accepted label must be
attached to the shipping papers, and left with the consignee at
the time of delivery.
(B) Storage. When pesticide products are stored in bulk
containers, whether mobile or stationary, which remain in the
custody of the user, a copy of the label or labeling, including
all appropriate directions for use, shall be securely attached to
the container in the immediate vicinity of the discharge control
valve.
(5) False or misleading statements. Pursuant to section
2(q)(l)(A) of the Act, a pesticide or a device declared subject
to the Act pursuant to §162.15, is misbranded if its labeling is
false or misleading in any particular including both pesticidal
and non-pesticidal claims. Examples of statements or representa-
tions in the labeling which constitute misbranding include:
(i) A false or misleading statement concerning the composition
of the product;
(ii) A false or misleading statement concerning the effective-
ness of the product as a pesticide or device;
(iii) A false or misleading statement about the value of the
product for purposes other than as a pesticide or device;
(iv) A false or misleading comparison with other pesticides or
devices;
(v) Any statement directly or indirectly implying that the
pesticide or device is recommended or endorsed by any Agency of
the Federal Government;
(vi) The name of a pesticide which contains two or more
principal active ingredients if the name suggests one or more but
not all such principal active ingredients even though the names
of the other ingredients are stated elsewhere in the labeling;
(vii) A true statement used in such a way as to give a false
or misleading impression to the purchaser;
(viii) Label disclaimers which negate or detract from labeling
statements required under the Act and these regulations;
-------
(ix) Claims as to the safety of the pesticide or its
ingredients, including statements such as "safe," "nonpoisonous,"
"noninjurious," "harmless" or "nontoxic to humans and pets" with
or without such a qualifying phrase as "when used as directed;"
and
(x) Non-numerical and/or comparative statements on the safety
of the product, including but not limited to:
(A) "Contains all natural ingredients";
(B) "Among the least toxic chemicals known"; and
(C) "Pollution approved."
(6) Final printed labeling. (i) Except as provided in
paragraph (a)(6)(ii) of this section, final printed labeling must
be submitted and accepted prior to registration. However, final
printed labeling need not be submitted until draft label texts
have been provisionally accepted by the Agency.
(ii) Clearly legible reproductions or photo reductions will be
accepted for unusual labels such as those silk-screened directly
onto glass or metal containers or large bag or drum labels. Such
reproductions must be of microfilm reproduction quality.
(b) Name, brand, or trademark. (1) The name, brand, or
trademark under which the pesticide product is sold shall.appear
on the front panel of the label.
(2) No name, brand, or trademark may appear on the label
which:
(i) Is false or misleading, or
(ii) Has not been approved by the Administrator through
registration or supplemental registration as an additional name
pursuant to §162.6(b)(4).
(c) Name and address of producer, registrant, or person for
whom produced. An unqualified name and address given on the
label shall be considered as the name and address of the
producer. If the registrant's name appears on the label and the
registrant is not the producer, or if the name of the person for
whom the pesticide was produced appears on the label, it must be
qualified by appropriate wording such as "Packed for ***,"
"Distributed by ***," or "Sold by ***" to show that the name is
not that of the producer.
(d) Net weight or measure of contents. (1) The net weight or
measure of content shall be exclusive of wrappers or other
materials and shall be the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide is a liquid, the net content statement
shall be in terms of liquid measure at 68 degrees F (20 degrees
C) and shall be expressed in conventional American units of fluid
ounces, pints, quarts, and gallons.
(3) If the pesticide is solid or semisolid, viscous or
pressurized, or is a mixture of liquid and solid, the net content
statement shall be in terms of weight expressed as avoirdupois
pounds and ounces.
(4) In all cases, net content shall be stated in terms of the
largest suitable unit, i.e., "1 pound 10 ounces" rather than "26
ounces."
119
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(5) In addition to the required units specified, net content
may be expressed in metric units.
(6) Variation above minimum content or around an average is
permissible only to the extent that it represents deviation
unavoidable in good manufacturing practice. Variation below a
stated minimum is not permitted. In no case shall the average
content of the packages in a shipment fall below the stated
average content.
(e) Product registration number. The registration number
assigned to the pesticide product at the time of registration
shall appear on the label, preceded by the phrase "EPA Registra-
tion No.," or the phrase "EPA Reg. No." The registration number
shall be set in type of a size and style similar to other print
on that part of the label on which it appears and shall run
parallel to it. The registration number and the required
identifying phrase shall not appear in such a manner as to
suggest or imply recommendation or endorsement of the product by
the Agency.
(f) Producing establishment registration number. The
producing establishment registration number preceded by the
phrase "EPA Est.," of the final establishment at which the
product was produced may appear in any suitable location on the
label or immediate container. It must appear on the wrapper or
outside container of the package if the EPA establishment
registration number on the immediate container cannot be clearly
read through such wrapper or container.
(g) Ingredient statement—(1) General. The label of each
pesticide product must bear a statement which contains the name
and percentage by weight of each active ingredient, the total
percentage by weight of all inert ingredients; and if the
pesticide contains arsenic in any form, a statement of the
percentages of total and water-soluble arsenic calculated as
elemental arsenic. The active ingredients must be designated by
the term "active ingredients" and the inert ingredients by the
term "inert ingredients," or the singular forms of these terms
when appropriate. Both terms shall be in the same type size, be
aligned to the same margin and be equally prominent. The
statement "Inert Ingredients, none" is not required for pes-
ticides which contain 100 percent active ingredients. Unless the
ingredient statement is a complete analysis of the pesticide, the
term "analysis" shall not be used as a heading for the ingredient
statement.
(2) Position of ingredient statement, (i) The ingredient
statement is normally required on the front panel of the label.
If there is an outside container or wrapper through which the
ingredient statement cannot be clearly read, the ingredient
statement must also appear on such outside container or wrapper.
If the size or form of the package makes it impracticable to
place the ingredient statement on the front panel of the label,
permission may be granted for the ingredient statement to appear
elsewhere.
120
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(ii) The text of the ingredient statement must run parallel
with other text on the panel on which it appears, and must be
clearly distinguishable from and must not be placed in the body
of other text.
(3) Names to be used in ingredient statement. The name used
for each ingredient shall be the accepted common name, if there
is one, followed by the chemical name. The common name may be
used alone only if it is well known. If no common name has been
established, the chemical name alone shall be used. In no case
will the use of a trademark or proprietary name be permitted
unless such name has been accepted as a common name by the
Administrator under the authority of Section 25(c)(6).
(4) Statements of percentages. The percentages of ingredients
shall be stated in terms of weight-to-weight. The sum of
percentages of the active and the inert ingredients shall be 100.
Percentages shall not be expressed by a range of values such as
"22-25%." If the uses of the pesticide product are expressed as
weight of active ingredient per unit area, a statement of the
weight of active ingredient per unit volume of the pesticide
formulation shall also appear in the ingredient statement.
(5) Accuracy of stated percentages. The percentages given
shall be as precise as possible reflecting good manufacturing
practice. If there may be unavoidable variation between
manufacturing batches, the value stated for each active in-
gredient shall be the lowest percentage which may be present.
(6) Deterioration. Pesticides which change in chemical
composition significantly must meet the following labeling
requirements:
(i) In cases where it is determined that a pesticide formula-
tion changes chemical composition significantly, the product must
bear the following statement in a prominent position on the
label: "Not for sale or use after [date]."
(ii) The product must meet all label claims up to the
expiration time indicated on the label.
(7) Inert ingredients. The Administrator may require the name
of any inert ingredient(s) to be listed in the ingredient
statement if he determines that such ingredient(s) may pose a
hazard to man or the environment.
(h) Warnings and precautionary statements. Required warnings
and precautionary statements concerning the general areas of
toxicological hazard including hazard to children, environmental
hazard, and physical or chemical hazard fall into two groups:
those required on the front panel of the labeling and those which
may appear elsewhere. Specific requirements concerning content,
placement, type size, and prominence are given below.
(1) Required front panel statements. With the exception of
the child hazard warning statement, the text required on the
front panel of the label is determined by the Toxicity Category
of the pesticide. The category is assigned on the basis of the
highest hazard shown by any of the indicators in the table below:
121
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f%li-Ly ^JS3
Opal
*f){' n^lyih- \f^
TVgTffil
I
Son
tbtoani
50 ing/tog
Iptoani
jrrfhrttrg
tbtoani
including
200:
QzrcKrve;
orr
rot
(TynnLv^
Ron 50 thru
SQOug/fcg
lion .2 thru
EEnn200
thru 2000
opacity
within?
at 72 hours
JS
Ron 500 thru
5000
Pion 2 thru
20
Run 2000 thru
20,000
R> ortreal opacity;
IT T 11 y^rf im
r&osible
within? d^s
at 72 bass
tjfc^p^TPJ^
5000
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th
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Ifo
Mildorsli^t
i T^^ T JjfCJf^^ ^[C
72hmrB
(i) Human hazard signal word—(A) Toxicity Category I. All
pesticide products meeting the criteria of Toxicity Category I
shall bear on the front panel the signal word "Danger." In
addition if the product was assigned to Toxicity Category I on
the basis of its oral, inhalation or dermal toxicity (as distinct
from skin and eye local effects) the word "Poison" shall appear
in red on a background of distinctly contrasting color and the
skull and crossbones shall appear in immediate proximity to the
word "Poison."
(B) Toxicitv Category II. All pesticide products meeting the
criteria of Toxicity Category II shall bear on the front panel
the signal word "Warning."
(C) Toxicitv Category III. All pesticide products meeting the
criteria of Toxicity Category III shall bear on the front panel
the signal word "Caution."
(D) Toxicity Category IV. All pesticide products meeting the
criteria of Toxicity Category IV shall bear on the front panel
the signal word "Caution."
(E) Use of signal words. Use of any signal word(s) associated
with a higher Toxicity Category is not permitted except when the
Agency determines that such labeling is necessary to prevent
unreasonable adverse effects on man or the environment. In no
case shall more than one human hazard signal word appear on the
front panel of a label.
122
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(ii) Child hazard warning. Every pesticide product label
shall bear on the front panel the statement "Keep out of reach of
children." Only in cases where the likelihood of contact with
children during distribution, marketing, storage or use is
demonstrated by the applicant to be extremely remote, or if the
nature of the pesticide is such that it is approved for use on
infants or small children, may the Administrator waive this
requirement.
(iii) Statement of practical treatment—• (A) Toxicity Category
I. A statement of practical treatment (first aid or other) shall
appear on the front panel of the label of all pesticides falling
into Toxicity Category I on the basis of oral, inhalation or
dermal toxicity. The Agency may, however, permit reasonable
variations in the placement of the statement of practical
treatment is some reference such as "See statement of practical
treatment on back panel" appears on the front panel near the word
"Poison" and the skull and crossbones.
(B) Other toxicitv categories. The statement of practical
treatment is not required on the front panel except as described
in paragraph (h)(1)(iii)(A) of this section. The applicant may,
however, include such a front panel statement at his option.
Statements of practical treatment are, however, required
elsewhere on the label in accord with paragraph (h)(2) of this
section if they do not appear on the front panel.
(iv) Placement and prominence. All the required front panel
warning statements shall be grouped together on the label, and
shall appear with sufficient prominence relative to other front
panel text and graphic material to make them unlikely to be
overlooked under customary conditions of purchase and use. The
following table shows the minimum type size requirements for the
front panel warning statements on various sizes of labels:
Size of Label Front Panel
in Square Inches
Above 10 to 15 .
Above 15 to 30
Poii
Required
signal word,
all capitals
g
10
12
14
18
its
"Keep out
of reach of
Children"
10
1 9
±Łi
123
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(2) Other required warnings and precautionary statements. The
warnings and precautionary statements as required below shall
appear together on the label under the general heading "Precau-
tionary Statements" and under appropriate subheadings of "Hazard
to Humans and Domestic Animals," "Environmental Hazard" and
"Physical or Chemical Hazard."
(i) Hazard to humans and domestic animals. (A) Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. The precautionary paragraph shall
be immediately preceded by the appropriate hazard signal word.
(B) The following table depicts typical precautionary
statements. These statements must be modified or expanded to
reflect specific hazards.
in
SLatatgts by Tcxicity catecpty
~im. cr* TpymBl
E&al fc
soT
s)
if aaUcwed [irhalfld cr
fljH'ilnl Uitux^i skin]. Do not breaHs
vapac [dst or f^rsy mist]. Don±get
in eyes, cn skin, cr on clothing. [Eccrt
ponel stat3Bxent of practical
be fatal if s*aUcued [irtalfld cr
ft R"i t'Hl lilm I.TJI the skin] . Do rot IIHHH IB
[Art cr spay mist]. Do rat get in
cn skin, or en clothing. Pil" l*"13'^'
fust aid statanats regpinad.]
Hmnflil if aunllffled [irtelai or atarfcad
thccu^i the skin] . Acrid trasthirg vapxs
[djst or spsy •mjfit*-] . Acrid lt IfTl rW%MJ*^l >^-
(ii) Environmental hazards. Where a hazard exists to
nontarget 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. Examples of the hazard statements
and the circumstances under which they are required follow:
124
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(A) If a pesticide intended for outdoor use contains an active
ingredient with a mammalian acute oral LDso of 100 or less, the
statement "This Pesticide is Toxic to Wildlife" is required.
(B) If a pesticide intended for outdoor use contains an active
ingredient with a fish acute LC50 of 1 ppm or less, the statement
"This Pesticide is Toxic to Fish" is required.
(C) If a pesticide intended for outdoor use contains an active
ingredient with an avian acute oral LD50 of 100 mg/kg or less, or
a subacute dietary LCso of 500 ppm or less, the statement "This
Pesticide is Toxic to Wildlife" is required.
(D) If either accident history or field studies demonstrate
that use of the pesticide may result in fatality to birds, fish
or mammals, the statement "This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) For uses involving foliar application to agricultural
crops, forests, or shade trees, or for mosquito abatement
treatments, pesticides toxic to pollinating insects must bear
appropriate label cautions.
(F) For all outdoor uses other than aquatic applications the
label must bear the caution "Keep out of lakes, ponds or streams.
Do not contaminate water by cleaning of equipment or disposal of
wastes."
(iii) Physical or chemical hazards. Warning statements on the
flammability or explosive characteristics of the pesticide are
required as follows:
L
Flashpcririt at or hplcw 20 ctrpnaas F; if there is
a flat-Hade at any \alve opening.
atove 20 degrees F ard not over 80
degrees F the flairs extersim is acre than IB
irches Icrcf at a distarne cf 6 inches frcm the
OCTET* 1'y^^j^^yi
n j IHI i R vrdBC
130
susy On iii fire, y^atte, and
^ i jjt, Tvt 1 ,\i n*'p nr jncmsrate
D^XEUEB to tHipaatures above
Viiml irtj.
Oj < n < g
Cfun heat, spades, and open f]?n&- Do not
p ^ i ^ ff v* i y Tit Mppysn^ CT^rr^] ] '^i^^. TJJ i HTtT3> uO
teopsEatures abac 130 degrees Fnay
bursting.
Qxterts infer preaeure. Do not use or store
near heat or open flats. Do not puncture or
oojcainsr*. ppA 1^3 m^ to
V30 iVi-ffn*-*^ F TTPV
I
At or bsskw 20 ctegtees ............. | Ddbsnely flamable. Ifeap avey fron file,
20 degrees F and not over 80 degrees F
F and not
| FJamEbLe. Ifeep away from heat and open flane,
heat <
)25
-------
(i) Directions for Use—(1) General requirements—(i)
Adequacy and clarity of directions. Directions for use must be
stated in terms which can be easily read and understood by the
average person likely to use or to supervise the use of the
pesticide. When followed, directions must be adequate to protect
the public from fraud and from personal injury and to prevent
unreasonable adverse effects on the environment.
(ii) placement of directions for use. Directions may appear
on any portion of the label provided that they are conspicuous
enough to be easily read by the user of the pesticide product.
Directions for use may appear on printed or graphic matter which
accompanies the pesticide provided that:
(A) If required by the Agency, such printed or graphic matter
is securely attached to each package of the pesticide, or placed
within the outside wrapper or bag;
(B) The label bears a reference to the directions for use in
accompanying leaflets or circulars, such as "See directions in
the enclosed circular"; and
(C) The Administrator determines that it is not necessary for
such directions to appear on the label.
(iii) Exceptions to requirement for directions for use—(A)
Detailed directions for use may be omitted from labeling of
pesticides which are intended for use only by manufacturers of
products other than pesticide products in their regular manufac-
turing processes, provided that:
(1) The label clearly shows that the product is intended for
use only in manufacturing processes and specifies the type(s) of
products involved.
(2) Adequate information, such as technical data sheets or
bulletins, is available to the trade specifying the type of
product involved and its proper use in manufacturing processes;
(1) The product will not come into the hands of the general
public except after incorporation into finished products; and
(4.) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(B) Detailed directions for use may be omitted from the
labeling of pesticide products for which sale is limited to
physicians, veterinarians, or druggists, provided that:
(1) The label clearly states that the product is for use only
by physicians or veterinarians;
(2.) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment; and
(2.) The product is also a drug and regulated under the
provisions of the Federal Food, Drug, and Cosmetic Act.
(C) Detailed directions for use may be omitted from the
labeling of pesticide products which are intended for use only by
formulators in preparing pesticides for sale to the public,
provided that:
(1) There is information readily available to the formulators
on the composition, toxicity, methods of use, applicable
126
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restrictions or limitations, and effectiveness of the product for
pesticide purposes;
(2.) The label clearly states that the product is intended for
use only in manufacturing, formulating, mixing, or repacking for
use as a pesticide and specifies the type(s) of pesticide
products involved;
(1) The product as finally manufactured, formulated, mixed, or
repackaged is registered; and
(1) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(2) Contents of Directions for Use. The directions for use
shall include the following, under the heading "Directions for
Use""
(i) The statement of use classification as prescribed in
162.10(j) immediately under the heading "Directions for Use."
(ii) Immediately below the statement of use classification,
the statement "It is a violation of Federal law to use this
product in a manner inconsistent with its labeling."
(iii) The site(s) of application, as for example the crops,
animals, areas, or objects to be treated.
(iv) The target pest(s) associated with each site.
(v) The dosage rate associated with each site and pest.
(vi) The method of application, including instructions for
dilution, if required, and type(s) of application apparatus or
equipment required.
(vii) The frequency and timing of applications necessary to
obtain effective results without causing unreasonable adverse
effects on the environment.
(viii) Specific limitations on reentry to areas where the
pesticide has been applied, meeting the requirements concerning
reentry provided by 40 CFR Part 170.
(ix) Specific directions concerning the storage and disposal
of the pesticide and its container, meeting the requirements of
40 CFR Part 165. These instructions shall be grouped and appear
under the heading "Storage and Disposal." This heading must be
set in type of the same minimum sizes as required for the child
hazard warning (See Table in §162.10(h)(1)(iv).)
(x) Any limitations or restrictions on use required to prevent
unreasonable adverse effects, such as:
(A) Required intervals between application and harvest of food
or feed crops.
(B) Rotational crop restrictions.
(C) Warnings as required against use on certain crops,
animals, objects, or in or adjacent to certain areas.
(D) [Reserved]
(E) For restricted use pesticides, a statement that the
pesticide may be applied under the direct supervision of a
certified applicator who is not physically present at the site of
application but nonetheless available to the person applying the
pesticide, unless the Agency has determined that the pesticide
127
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may only be applied under the direct supervision of a certified
applicator who is physically present.
(F) Other pertinent information which the Administrator
determines to be necessary for the protection of man and the
environment.
(j) Statement of Use Classification. By October 22, 1976, all
jpesticide products must bear on their labels a statement of use
classification as described in paragraphs (j)(1) and (2) of this
section. Any pesticide product for which some uses are class-
ified for general use and others for restricted use shall be
separately labeled according to the labeling standards set forth
in this subsection, and shall be marketed as separate products
with different registration numbers, one bearing directions only
for general use(s) and the other bearing directions for
restricted use(s) except that, if a product has both restricted
use(s) and general use(s), both of these uses may appear on a
product labeled for restricted use. Such products shall be
subject to the provisions of §162.10(j)(2).
(1) General Use Classification. Pesticide products bearing
directions for use(s) classified general shall be labeled with
the exact words "General Classification" immediately below the
heading "Directions for Use," and reference to the general
classification that suggests or implies that the general utility
of the pesticide extends beyond those purposes and uses contained
in the Directions for Use will be considered a false or mis-
leading statement under the statutory definitions of misbranding.
(2) Restricted Use Classification. Pesticide products bearing
direction for use(s) classified restricted shall bear statements
of restricted use classification on the front panel as described
below:
(i) Front panel statement of restricted use classification.
(A) At the top of the front panel of the label, set in type of
the same minimum sizes as required for human hazard signal words
(see table in 8162.10(h)(1)(iv)), and appearing with sufficient
prominence relative to other text and graphic material on the
front panel to make it unlikely to be overlooked under customary
conditions of purchase and use, the statement "Restricted Use
Pesticide" shall appear.
(B) Directly below this statement on the front panel, a
summary statement of the terms of restriction imposed as a
precondition to registration shall appear. If use is restricted
to certified applicators, the following statement is required:
HFor 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." If,
however, other regulatory restrictions are imposed, the Admi-
nistrator will define the appropriate wording for the terms of
restriction by regulation.
(k) Advertising. [Reserved]
128
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[40 CF 28268, July 3, 1975; 40 FR 32329, August 1, 1975; 40 FR
38571, August 21, 1975, as amended at 43 FR 5786, February 9,
1978; amended at 53 FR 15952, May 4, 1988.
129
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PHYSICAL-CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A.
Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B.
Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
ALL OTHER PRESSURIZED
CONTAINERS
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire,
sparks, and heated
surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents
under pressure. Keep
away from heat, sparks,
and flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do
not puncture or incine-
rate container. Exposure
to temperatures above
130°F may cause bursting.
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.
13Q
-------
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.
131
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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.1*
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.11
3. The labels of all products, except those intended for
domestic use, containing active or inert ingredients that are
Toxic Hazardous Wastes or meet any of the criteria in 40 CFR 261,
Subpart C for a hazardous waste must bear the following pesticide
disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of
Federal Law. If these wastes cannot be disposed of by use
according to label instructions, contact your State
Pesticide or Environmental Control Agency, or the Hazardous
Waste representative at the nearest EPA Regional Office for
guidance."
4. Labels for all other products, except those intended for
domestic use, must bear the following pesticide disposal
statement:
"Wastes resulting from the use of this product may be
disposed of on site or at an approved waste disposal
facility."
5. Products intended for domestic use only must bear the
following disposal statement: "Securely wrap original container
in several layers of newspaper and discard in trash."
132
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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 Tvr»e Statement
Non-aerosol products
( bottles, cans, iars)
Non-aerosol products
(baas)
Aerosol products
Do not reuse container (bottle, can, jar) .
Rinse thorouahlv before discardina in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
2. All other products must bear container disposal
instructions, based on container type, listed below:
Zontainer Tvce Statement
Metal
containers
(non-aerosol)
Plastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Triple rinse (or equivalent) . Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities .
Triple rinse (or equivalent) . Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stav out of smoke.
Triple rinse (or equivalent) . Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused^/, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wordincr) .
V Manufacturer may replace this phrase with one indicating whether
and how fiber drum may be reused.
133
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III. BIBLIOGRAPHY APPENDICES
134
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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 with a conventional bibliographic
citation. The Agency has attempted-also to unite basic documents
and commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or MRID,
number. This number is unique to the citation, and should be used
at any time specific reference is required. It is not related to
the six-digit "Accession Number" which has been used to identify
volumes of submitted studies; see paragraph 4(d)(4) below for a
further explanation. In a few cases, entries added to the
bibliography late in the review may be preceded by a nine-
character temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is also to be
used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing standard
elements followed, in the case of material submitted to EPA, by a
description of the earliest known submission. Bibliographic
conventions used reflect the standards of the American National
Standards Institute (ANSI), expanded to provide for certain
special needs.
a. Author. Whenever the Agency could confidently
identify one, the Agency has chosen to show a
personal author. When no individual was
identified, the Agency has shown an identifiable
laboratory or testing facility as author. As a
last resort, the Agency has shown the first
submitter as author.
135
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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:
(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.
136
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the MCPA Standard
MRID Citation
)0004439 Jensen, D.J.; Miller, P.W.; Berhenke, L.F. (1973) Total Residues of
MCPA and 2-Methyl-4-chlorophenol in Tissues of Animals Fed MCPA:
Report No. GH-C-689. (Unpublished study received on unknown
date under 9F0761; submitted by Dow Chemical U.S.A., Midland,
Mich.; CDL:092000-D)
10004443 Thornburg, W. (1973) MCPA Residues in Peas: A Summary of Residue
Data. (Unpublished study received on unknown date under 9F0761;
prepared by Del Monte Corp., submitted by Dow Chemical U.S.A.,
Midland, Mich.; CDL:092000-1)
0004449 Guardigli, A.; Henckler, P.M. (1973) Final Summary: MCPA and Phenol
Metabolite in Pasture and/or Range Grasses. (Unpublished study
received on unknown date under 9F0761; prepared by Rhodia, Inc.,
submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:092001-F)
0004453 Winterlin, M.; Radosivich, S.R. (1974) Report of Analysis: Environ-
mental Toxicology Report No. 3445. Includes undated method.
(Unpublished study received Feb 10, 1976 under 6E1746; prepared
by Univ. of California—Davis, Dept. of Environmental Toxicol-
ogy, submitted by Interregional Research Project No. 4, New
Brunswick, N.J.; CDL:095368-C)
0004491 Herman, J.L.; Bjerke, E.L.; Getzendaner, M.E. (1970) Residue of
2-Methyl-4-chlorophenoxyacetic acid and 2-Methyl-4-chlorophenol
in Milk and Cream from Cows Fed MCPA. (Unpublished study re-
ceived Jan 11, 1971 under 9F0761; prepared by Dow Chemical Co.,
submitted by National Agricultural Chemicals Association, Indus-
try Task Force on Phenoxy Herbicide Tolerances, Washington,
D.C.; CDL:091313-I)
0004492 Herman, J.L.; Bjerke, E.L. (1970) Determination of MCPA and 2-Meth-
yl-4-chlorophenol in Milk and Cream by Gas Chromatography.
Method no. ACR 70.17 dated Dec 2, 1970. (Unpublished study re-
ceived Jan 11, 1971 under 9F0761; prepared by Dow Chemical Co.,
submitted by National Agricultural Chemicals Association, Indus-
try Task Force on Phenoxy Herbicide Tolerances, Washington,
D.C.; CDL:091313-J)
)0004493 Amchem Products, Incorporated (1968) Summary of Performance Data:
[Brominal Plus]. Summary of studies 002199-B through 002199-P.
(Unpublished study received Oct 30, 1968 under 264-239; sub-
mitted by Union Carbide Agricultural Products Co., Ambler, Pa.;
CDL:002199-A)
137
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered of the Data Base Supporting
Registrations Under the MCPA Standard
MRID Citation
00004512 Bentley, R.E. (1974) Bioassay Report Submitted to Amchem Products,
Inc., Ambler, Pennsylvania: Acute Toxicity of Three Amchem Com-
pounds to Bluegill (Lepomis macrochirus) and Rainbow Trout
(Salmo gairdneri). (Unpublished study received Sep 13, 1974
under 264-55; prepared by Bionomics, EG&G, Inc., submitted by
Union Carbide Agricultural Products Co., Ambler, Pa.; CDL:
131084-B)
00004613 Higham, J.W.; Feeny, R.W; Cheston, K.G.; Snyder, E.H.; Nowatski,
R.; O'Hare, T.R. (1975) Avenge (CL 84,777): Determination
of CL 84,777 (l,2-Dimethyl-3,5-diphenyl pyrazolium methyl sul-
fate), Bromoxynil (3,5-Dibromo-4-hydroxylbenzonitrile) and MCPA
(2-Methyl-4-chlorophenoxyacetic acid) Residues in Barley Grain
and Straw Following Ground Application of Avenge Alone and in
Combination with MCPA, Bromoxynil or 2,4-D (North Dakota): Re-
port No. C-596. (Unpublished study received Jan 8, 1975 under
241-EX-64; prepared in cooperation with Lake Ontario Environ-
mental Laboratory, submitted by American Cyanamid Co., Prince-
00004624 Herman, J.L.; Bjerke, E.L.; Getzendaner, M.E. (1971) Residues of
2-Methyl-4-chlorophenoxyacetic acid and 2-Methyl-4-chlorophenol
in Milk and Cream from Cows Fed MCPA. (Unpublished study re-
ceived Oct 11, 1971 under 9F0761; prepared by Dow Chemical Co.,
submitted by National Agricultural Chemicals Association, Indus-
try Task Force on Phenoxy Herbicide Tolerances, Washington,
D.C.; CDL:091311-E)
00004625 Bjerke, E.L.; Herman, J.L. (1971) Residues of 2-Methyl-4-chloro-
phenoxyacetic acid and 2-Methyl-4-chlorophenol in Tissues of
Beef Calves Fed MCPA. (Unpublished study received Oct 11, 1971
under 9F0761; prepared by Dow Chemical Co., submitted by Nation-
al Agricultural Chemicals Association, Industry Task Force on
Phenoxy Herbicide Tolerances, Washington, D.C.; CDL:091311-F)
00004626 Bjerke, E.L.; Herman, J.L. (1971) Residues of 2-Methyl-4-chloro-
phenoxyacetic acid and 2-Methyl-4-chlorophenol in Tissues of
Sheep Fed MCPA. (Unpublished study received Oct 11, 1971 under
9F0761; prepared by Dow Chemical Co., submitted by National
Agricultural Chemicals Association, Industry Task Force on
Phenoxy Herbicide Tolerances, Washington, D.C.; CDL:091311-G)
138
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered of the Data Base Supporting
Registrations Under the MCPA Standard
MRID Citation
0004627 Herman, J.L.; Bjerke, E.L. (1971) Determination of MCPA and 2-
Methyl-4-chlorophenol in Cattle and Sheep Tissues by Gas Chroma-
tography. Method ACR 71.10 dated Jun 24, 1971. (Unpublished
study received Oct 11, 1971 under 9F0761; prepared by Dow Chem-
ical Co., submitted by National Agricultural Chemicals Associa-
tion, Industry Task Force on Phenoxy Herbicide Tolerances,
Washington, D.C.; CDL:091311-H)
0004632 Higham, J.W. (1974) The Gas Chromatographic Determination of MCPA
(2-Methyl-4-chlorophenoxyacetic acid) and Bromoxynil (3,5-Dibro-
mo-4-hydroxybenzonitrile) in Fortified Wheat Grain and Straw:
Report No. C-575. (Unpublished study received Nov 14, 1975
under 6F1703; prepared in cooperation with State Univ. of New
York—Oswego, Lake Ontario Environmental Laboratory, submitted
by American Cyanamid Co., Princeton, N.J.; CDL:094738-D)
D004651 Higham, J.W.; Feeny, R.W. (1974) Avenge: (CL 84,777): Determi-
nation of MCPA (2-Methyl-4-chlorophenoxyacetic acid) Residues in
Wheat Grain and Straw Following Ground, Postemergence Applica-
tion in Combination with Avenge (l,2-Dimethyl-3,5-diphenyl pyra-
zolium methyl sulfate), (Oregon): Report No. C-576. (Unpub-
lished study received Nov 14, 1975 under 6F1703; prepared in
cooperation with State Univ. of New York—Oswego, Lake Ontario
Environmental Laboratories, submitted by American Cyanamid Co.,
Princeton, N.J.; CDL:094738-Y)
D004655 Elenewski, C.A.; Wang, T. (1975) Avenge: (CL 84,777): Determi-
nation of CL 84,777 (l,2-Dimethyl-3,5-diphenyl-lH-pyrazolium
methyl sulfate), Bromoxynil (3,5-Dibromo-4-hydroxylbenzonitrile)
and MCPA (2-Methyl-4-chlorophenoxyacetic acid) Residues in Durum
Wheat Grain and Straw Following Aerial Application of Avenge
Alone and in Combination with MCPA or Bromoxynil, (Minnesota):
Report No. C-823. (Unpublished study received Nov 14, 1975 un-
der 6F1703; prepared in cooperation with Biodynamics, Inc., sub-
mitted by American Cyanamid Co., Princeton, N.J.; CDL:094738-AD)
0004659 Elenewski, C.A.; Wang, T. (1975) Avenge: (CL 84,777): Determi-
nation of CL 84,777 (l,2-Dimethyl-3,5-diphenyl-lH-pyrazolium
methyl sulfate), Bromoxynil (3,5-Dibromo-4-hydroxylbenzonitrile)
and MCPA (2-Methyl-4-chlorophenoxyacetic acid) Residues in Wheat
Grain and Straw Following Ground Application of Avenge Alone and
in combination with MCPA or Bromoxynil, (Oregon): Report No. C-
820. (Unpublished study received Nov 14, 1975 under 6F1703;
prepared in cooperation with Biodynamics, Inc., submitted by
American Cyanamid Co., Princeton, N.J.; CDL:094738-AH)
139
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered of the Data Base Supporting
Registrations Under the MCPA Standard
MRID Citation
00004724 St. John, L.E., Jr. (1967) MCPA. Pages 445-454, In Analytical
Methods for Pesticides, Growth Regulators and Food Additives:
Volume 5. Edited by G. Zweig. New York: Academic Press. (Al-
so in unpublished submission received Sep 12, 1968 under 8F0676;
submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:092980-AP)
00004764 Devine, J.M. (1970) Report on MCPA Residues in Rough Rice & Rice
Straw. Includes two undated methods. (Unpublished study re-
ceived Jan 22, 1971 under 9F0761; prepared by Syracuse Univ. Re-
search Corp., submitted by National Agricultural Chemicals Asso-
ciation, Industry Task Force on Phenoxy Herbicide Tolerances,
Washington, D.C.; CDL:091308-L)
00004766 Guardigli, A. (1970) MCPA Residues in Flax Seed: Field Test Project
No. STP 69-26; 69-27. Includes method no. 104 dated Nov 25,
1969. (Unpublished study received Jan 22, 1971 under 9F0761;
prepared by Rhodia, Inc. in cooperation with Univ. of Minnesota
and North Dakota State Univ. of Agriculture and Applied
Science, submitted by National Agricultural Chemicals Associa-
tion, Industry Task Force on Phenoxy Herbicide Tolerances, Wash-
ington, D.C.; CDL:091308-O)
00004773 Monsanto Company (1956) [MCP Residue in and Recovery of MCP from
Garden Peas, Flax, Rice, and Oats]. (Unpublished study received
Oct 19, 1971 under 8F0676; submitted by National Agricultural
Chemicals Association, Industry Task Force on Phenoxy Herbicide
Tolerances, Washington, D.C.; CDL:091183-O)
00004787 Guardigli, A. (1974) Rhodia Analytical Method No. 123. Includes
two methods dated March 1974. (Unpublished study received Jan
30, 1976 under 359-534; prepared by Rhodia, Inc., submitted by
Rhone-Poulenc, Inc., Monmouth Junction, N.J.; CDL:222737-A)
00004822 Guyton, C.L. (1977) Procedures for the Measurement of Asulam, MCPA,
Sulfanilamide and Acetylasulam in/on Flax: Forages, Straw, Seed
and Mill-Processed Flax Seed Fractions. Method no. 143 dated
Jul 1977. (Unpublished study received Apr 13, 1979 under 359-
662; prepared by Rhodia, Inc., submitted by Rhone-Poulenc, Inc.,
Monmouth Junction, N.J.; CDL:238025-B)
00004993 IR-4 Project at Rutgers, the State University (1974) MCPA—Sorghum
Residue Studies. (Unpublished study received Oct 3, 1975 under
6E1681; CDL:097351-A)
140
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered of the Data Base Supporting
Registrations Under the MCPA Standard
MRID Citation
0005567 Higham, J.W.; Feeny, R.W.; Cheston, K.G.; Snyder, E.H.; Wingfield,
C.B. (1975) Avenge: (AC 84,777): Determination of CL 84,
777 (l,2-Dimethyl-3,5-diphenyl pyrazolium methyl sulfate), Bro-
moxynil (3,5-Dibromo-4-hydroxylbenzonitrile) and MCPA (2-Methyl-
4-chlorophenoxyacetic acid) Residues in Barley Grain and Straw
Following Ground Application (Colorado): Report No. C-594. (Un-
published study received Jan 8, 1975 under 241-EX-64; prepared
in cooperation with Lake Ontario Environmental Laboratory, sub-
mitted by American Cyanamid Co., Princeton, N.J.; CDL:224170-T)
0005575 Montgomery, M.L. (1970) MCPA Residue in Wheat: Oregon State Univer-
sity Report. Includes methods dated Jun 17, 1970 and Apr 1,
1970. (Unpublished study including summary report and letters
dated Apr 2, 1970 from M.L. Montgomery to Don T. Lillie and J.A.
Ignatoski, received Jan 22, 1971 under 9F0761; prepared by Ore-
gon State Univ., Dept. of Agricultural Chemistry, submitted by
National Agricultural Chemicals Association, Industry Task Force
on Phenoxy Herbicide Tolerances, Washington, D.C.; CDL:091308-I)
3021972 Raltech Scientific Services, Incorporated (1979) Oral Defined LD50.
(Unpublished study received Jul 16, 1979 under 39335-1; submit-
ted by Fallek-Lankro Corp., Tuscaloosa, Ala.; CDL:238870-B)
3021974 Raltech Scientific Services, Incorporated (1979) Eye Irritation.
(Unpublished study received Jul 16, 1979 under 39335-1; submit-
ted by Fallek-Lankro Corp., Tuscaloosa, Ala.; CDL:238870-D)
0023687 Rydrych, D.; Behrens, R.; Wallace, K.; et al. (1972) [Residues from
Various Chemicals on Grains], (Unpublished study received Jan
3, 1973 under unknown admin, no.; prepared in cooperation with
Univ. of Minnesota and others, submitted by Velsicol Chemical
Corp., Chicago, 111.; CDL:120182-A)
0025394 Rydrich, D.; Wallace, K.; Beck, B.; et al. (1976) Residue Results:
Banvel plus Bromoxynil plus MCPA Tank Mix: Summary. (Unpub-
lished study received Feb 18, 1976 under 876-25; prepared in co-
operation with Oregon State Univ., submitted by Velsicol Chemi-
cal Corp., Chicago, 111.; CDL:225197-C)
0026927 Pitcher, F.G. (1973) [Spot Treat: Toxicity to Bluegill]: Test
No. 609. (U.S. Environmental Protection Agency, Pesticides Reg-
ulation Div., Agricultural Research Center, Animal Biology Lab-
oratory, unpublished report.)
141
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered of the Data Base Supporting
Registrations Under the MCPA Standard
MRID Citation
00026928 McCann, J.A.; Pitcher, F. (1972) [MCP Weed Killer: Toxicity to
Bluegill]: Test No. 512. (U.S. Agricultural Research Service,
Pesticides Regulation Div., Animal Biology Laboratory, unpub-
lished report.)
00027042 Bache, C.A.; Lisk, D.J.; Wagner, D.G.; et al. (19??) Elimination
of 2-Methyl-4-chlorophenoxyacetic acid and 4-(2-Methyl-4-chloro-
phenoxybutyric) acid in the urine from cows. Journal of Dairy
Science ? (? ):93-95. (Also in unpublished submission received
Jan 2, 1980 under 2217-641; submitted by FBI-Gordon Corp., Kan-
sas City, Kans.; CDL:241575-U)
00029654 Pitcher, F.G. (1976) [MCPA (2-Methyl-4-chlorophenoxy acetic acid):
Toxicity to Daphnia magna]: Test # 936. (U.S. Environmental
Protection Agency, Animal Biology Laboratory, unpublished re-
port. )
00029655 Pitcher, F. (1973) [Weedar Sodium MCPA: Toxicity to Bluegill]: Test
No. 693. (U.S. Environmental Protection Agency, Pesticides Reg-
ulation Div., Agricultural Research Center; Animal Biology
Laboratory, unpublished report.)
00041294 Pitcher, F.G. (1976) [MCPA 2-Methyl-4-chlorophenoxy acetic acid:
Toxicity to Rainbow Trout]: Test # 927. (U.S. Environmental
Protection Agency, Animal Biology Laboratory, unpublished re-
port. )
00041295 Pitcher, F.G. (1976) [MCPA 2-Methyl-4-chlorophenoxy acetic acid:
Toxicity to Bluegill]: Test # 942. (U.S. Environmental Protec-
tion Agency, Animal Biology Laboratory, unpublished report.)
00041296 McCann, J.A.; Pitcher, F. (1972) [Midland MCP Weed Killer: Toxicity
to Bluegill]: Test No. 512. (U.S. Agricultural Research Ser-
vice, Pesticides Regulation Div., Animal Biology Laboratory,
unpublished report.)
00041297 McCann, J.A.; Pitcher, F. (1972) [Midland MCP Weed Killer: Toxicity
to Rainbow Trout]: Test No. 525. (U.S. Environmental Protection
Agency, Pesticides Regulation Div., Agricultural Research Cen-
ter, Animal Biology Laboratory, unpublished report.)
142
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered of the Data Base Supporting
Registrations Under the MCPA Standard
MRID Citation
0041298 McCann, J.A.; Pitcher, F. (1973) [Dow MCP Amine Weed Killer: Toxic-
ity to Rainbow Trout]: Test No. 553. (U.S. Environmental Pro-
tection Agency, Pesticides Regulation Div., Agricultural Re-
search Center, Animal Biology Laboratory, unpublished report.)
0041299 McCann, J.A.; Pitcher, F. (1973) [Dow MCP Amine Weed Killer: Toxic-
ity to Bluegill]: Test No. 580. (U.S. Environmental Protection
Agency, Pesticides Regulation Div., Agricultural Research Cen-
ter, Animal Biology Laboratory, unpublished report.)
0041300 Pitcher, F.G. (1973) [Spot Treat: Toxicity to Bluegill]: Test
No. 628. (U.S. Environmental Protection Agency, Pesticides Reg-
ulation Div., Agricultural Research Center, Animal Biology
Laboratory, unpublished report.)
0041633 Keller, W.; Otto, S. (1979) Investigations into the Metabolism of
MCPA in Winter Wheat: Report No. 1611a. (Unpublished study in-
cluding submitter summary, received Aug 28, 1980 under 2217-EX-
2; prepared by BASF, AG, submitted by FBI-Gordon Corp., Kansas
City, Kans.; CDL:243167-A)
0041634 Gilbert, C.M.; Hopkins, R.; MacDonald, C.M.; et al. (1978) The Met-
abolic Fate of (14C)-MCPA (4-Chloro-2-methyl(Ring-U-14C) phenox-
yacetic acid) in the Rat: Report No. 1334R3-277/1. (Unpublished
study including submitter summary, received Sep 4, 1980 under
2217-EX-2; prepared by Hazleton Laboratories Europe, Ltd. and
Boots Co., Ltd., submitted by PBI-Gordon Corp., Kansas City,
Kans.; CDL:243193-A)
0053734 Akzo Zout Chemie Nederland, B.V. (1975) MCPA: Some Information on
Properties, Applications, Stability and Toxicity. Summary of
studies 231352-B through 231352-D, 231352-N, 231352-O, 231352-Q
through 231352-T, 231355-D, 231355-F through 231355-K, 231355-M
through 231355-R, 231355-U, 231355-Y and 231355-Z. (Unpublished
study received Aug 15, 1977 under 38117-3; CDL:231355-A)
0053755 Leafe, E.L. (1962) Metabolism and selectivity of plant-growth
regulator herbicides. Nature 193(Feb):485-486. (Also in un-
published submission received Aug 15, 1977 under 38117-2; sub-
mitted by Akzo Zout Chemie Nederland, B.V., Amsterdam, Holland;
CDL:231352-P)
143
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered of the Data Base Supporting
Registrations Under the MCPA Standard
MRID Citation
0059949 Pollock, R.J. (1980) Letter sent to Willa Y. Garner dated Mar 26,
1980 [Raw data for Nitrosamine levels found in Chas. H. Lilly
Co.'s products]. (Unpublished study received Aug 6, 1980 under
802-30; prepared by Analytical Development Corp., submitted by
Chas. H. Lilly Co., Miller Road Div., Portland, Oreg.; CDL:
243045-C)
00078931 Rohm & Haas Company (1978) Treatment and MCPA Residue Summary
for Barley & Oats. (Unpublished study received Jul 14, 1981
under 707-75; CDL:070183-B)
00079473 Rothman, L.D.; Wisniewiski, D.F.; Kracht, W.R. (1978) Analysis of
DMA:-4 Herbicide, DMA-6 Unsequestered Herbicide, DMA-6 Se-
questered Herbicide and MCP-amine Herbicide for N-nitrosodi-
methylamine: ML-AL 78-00370. Includes method dated Jun 19,
1978. (Unpublished study received Aug 24, 1978 under 464-467;
submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:245000-A)
00084292 Interregional Research Project Number 4 (1980) Summary of Residue
Chemistry Data. (Compilation; unpublished study received Sep
10, 1981 under 1E2577; CDL:070361-A)
00094623 Harwell, C.; Jones, C. (1981) Formal Report of Analysis for N-Ni-
troso Compounds. Includes method no. F-12-5-81 dated May 1981.
(Unpublished study, including published data, received Aug 14,
1981 under 677-430; submitted by Diamond Shamrock Agricultural
Chemicals, Cleveland, Ohio; CDL:245778-A)
00102704 National Agricultural Chemicals Assoc. (1973) The Results of Tests
on the Amount of Residue Remaining, Including a Description of
the Analytical Method Used: [2,4-DJ. (Compilation; unpublished
study received Sep 7, 1973 under 8F0670; CDL:092143-A)
00105215 Hazleton Raltech, Inc. (1982) MCP Amine 4, Clean Crop: Lot
No. 04GI33391: RT LAB NO. 948970. (Unpublished study received
Jul 8, 1982 under 34704-130; submitted by Platte Chemical Co.,
Fremont, NE; CDL:070959-A)
00126755 Kemisk Vaerk Koge A/S (1983) [Chemistry of KVK MCP Acid]. (Com-
pilation; unpublished study received Apr 12, 1983 under 11636-3;
CDL:249897-A)
144
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered of the Data Base Supporting
Registrations Under the MCPA Standard
MRID Citation
0144735 Kirsch, P. (1983) Report on the Study of the Acute Dermal Toxicity
in Rats of MCPA Dated August 17, 1983:sic:: RZ Report No. 83/
167. Unpublished study prepared by Basf AG. 9 p.
0145865 Carreon, R. (1985) MCPA Butoxyethyl Ester: Primary Dermal Irrita-
tion Study in New Zealand White Rabbits. Unpublished study pre-
pared by Dow Chemical U.S.A. 8 p.
0146192 Helling, C. ; Turner, B. (1968) Pesticide mobility: Determination by
soil thin-layer chromatography. Science 162(Nov):562-563.
0146317 Streeter, C. (1985) MCPA Butoxyethyl Ester: An Acute Aerosol Inhal-
ation Study with Rats. Unpublished study prepared by Dow Chemi-
cal U.S.A. 12 p.
3148720 Engelhardt, G. (1985) Cytogenetic Investigations in Chinese Ham-
sters after a Single Oral Administration of MCPA: :(4-Chloro-
2-methylphenoxy Acetic Acid):: Sister Chromatid Exchange (SCE):
Project No. 16M0046/8356: Supplementary Study. Unpublished
study prepared by BASF AG. 32 p.
D152836 Akzo Zout Chemie Nederland bv. (1983?) :Product Chemistry Data of
MCPA:. Unpublished compilation. 29 p.
D152867 Reuzel, P.; Hendriksen, C. (1980) Subchronic (13-week) Oral Toxici-
ty Study of MCPA in Beagle Dogs: Final Report: Project No.
B77/1867: Report Nos. R 6478 and R 6337. Unpublished study pre-
pared by Central Institute for Nutrition and Food Research. 315
P-
0154063 Dow Chemical USA (19??) Product Identity and Disclosure of Ingred-
ients ...:Product Chemistry of MCPA Isooctyl Ester (Technical):.
Unpublished study. 8 p.
0154064 Dow Chemical USA (1982?) Preliminary Analysis of Technical MCPA
Isooctyl Ester. Unpublished study. 9 p.
0154066 Dow Chemical USA (19??) Product Identity and Disclosure of Ingred-
ients ...: Product Chemistry of MCPA Butoxyethyl Ester (Techni-
cal) :. Unpublished study. 7 p.
0154067 Dow Chemical USA (1983) Preliminary Analysis of Technical MCPA
Butoxyethyl Ester. Unpublished study. 9 p.
145
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered of the Data Base Supporting
Registrations Under the MCPA Standard
MRID Citation
00154075 Dow Chemical USA (19??) Product Identity and Disclosure of Ingred-
ients. ..:Product Chemistry Data of MCPA Acid (Technical):. Un-
published study. 10 p.
00154076 Dow Chemical USA (1983?) Preliminary Analysis of MCPA Product Sam-
ples. Unpublished study. 50 p.
00155099 BASF Wyandotte Chemical Co. (1985) Product-specific Data Require-
ments for MCPA Manufacturing Use Products. Unpublished com-
pilation. 33 p.
00155233 Gilmore, Inc. (1985) Technical MCPA IOE...Product Chemistry Data:
:Product Identity:. Unpublished study. 8 p.
00155234 Gilmore, Inc. (1985) :Analytical Methodology of MCPA IOE Techni-
cal:. Unpublished compilation. 63 p.
00156456 Ullmann, L. (1985) Primary Skin Irritation Study with CL 8808/7 CE
in Rabbits: Report: Project 053572. Unpublished study prepared
by Research & Consulting Co. AG. 30 p.
00156457 Ullmann, L. (1985) Test for Delayed Contact Hypersensitivity in the
Albino Guinea Pig with CL 8808/7 CE: The Guinea Pig Maximization
Test: Report: Project 053594. Unpublished study prepared by
Research & Consulting Co. 43 p.
00156458 Ullmann, L. (1985) Acute Oral Toxicity (LD50) Study with CL 8808/7
CE in Rats: Report: Project 041927. Unpublished study prepared
by Research & Consulting Co. AG. 42 p.
00156459 Ullmann, L. (1985) Acute Dermal Toxicity (LD50) Study with
CL 8808/7 CE in Rats: Report: Project 042006. Unpublished study
prepared by Research & Consulting Co. AG. 23 p.
00156460 Ullmann, L. (1985) 4-Hour Acute Aerosol Inhalation Toxicity (LC50)
Study with CL 8808/7 CE in Rats: Report: Project 042017. Unpub-
lished study prepared by Research & Consulting Co. AG. 35 p.
00155743 Gilmore, Inc. (1985) :Product Chemistry Data for MCPA Technical
Acid:. Unpublished study. 84 p.
00158077 A. H. Marks & Co., Ltd. (19??) Manufacturing Process for MCPA
Technical Acid. Unpublished compilation. 10 p.
146
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered of the Data Base Supporting
Registrations Under the MCPA Standard
MRID Citation
10158078 A. H. Marks & Co., Ltd. (19??) Analysis and Certification of
Product Ingredients :of MCPA:. Unpublished study. 2 p.
0159470 Rhone-Poulenc Inc. (1986) Product Chemistry Data Requirements
under EPA Pesticide Assessment Guidelines Dated Oct. 1982: 2(-4-
Chloro-2-methylphenoxy) Acetic Acid, MCPA Tech.: ECD/JBU/LMC/
2108. Unpublished compilation. 136 p.
0160157 Carreon, R.; Battjes, J. ; Eisenbrandt, D. (1986) MCPA Butoxyethyl
Ester: Acute Dermal Toxicity Study in New Zealand White Rabbits,
Unpublished study prepared by Dow Chemical U.S.A. 16 p.
0160158 Carreon, R.; Battjes, J.; Eisenbrandt, D. (1985) MCPA Butoxyethyl
Ester: Acute Oral Toxicity Study in Fischer 344 Rats. Unpub-
lished study prepared by Dow Chemical U.S.A. 15 p.
0160160 Carreon, R. (1985) MCPA Butoxyethyl Ester: Dermal Sensitization
Study in Hartley Guinea Pigs. Unpublished study prepared by
Dow Chemical U.S.A. 9 P.
0163844 DeWitt, J.; Crabtree, D.; Finley, R.; et al. (1962) Effects on
wildlife. P. 4-6,33-34.47 in Effects of Pesticides on Fish
and Wildlife: A Review of Investigations during 1960. Fish
and Wildlife Circular No. 143.
0164352 Hellwig (1986) Report on the Study of the Toxicity of MCPA in
Beagle Dogs after 12-month Administration in the Diet: Project
No. 33D0046/8341. Unpublished study prepared by BASF Institute.
691 p.
0165471 Kirsch, P. (1985) Report on the Study of the Toxicity of MCPA in
Rats after 3 Months Administration in the Diet: :Range-finding
Study for 2-year Oncogenicity Study in Rats:: Project No.
31S0046/8302. Unpublished study prepared by BASF Ag. 381 p.
0019201 Grimes, J. (1986) MCPA Acid: An Acute Oral Toxicity Study with the
Bobwhite: Final Report: Wildlife International Ltd. Project No.
222-101. Unpublished study prepared by Wildlife International
Ltd. 19 p.
,0027501 Gelbke, H.; Engelhardt, G. (1986) Cytogenetic Investigations in
Chinese Hamsters after a Single Oral Administration of MCPA:
Bone Marrow Chromosomes Analysis: Project No. 10M0046/8367. Un-
published study prepared by BASF Aktiengesellschaft. 55 p.
147
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered of the Data Base Supporting
Registrations Under the MCPA Standard
MRID Citation
40041701 MacKenzie, K. (1986) Two-Generation Reproduction Study with MCPA in
Rats: Final Report: Study No. 6148-100. Unpublished study pre-
pared by Hazleton Laboratories America, Inc. 1304 p.
40053101 Klimisch, H. (1986) Acute Inhalation Toxicity LC50 4 Hours (Rat)
Dust Aerosol Study of MCPA: Project No. 1310046/83. Unpublished
study prepared by BASF Aktiengesellschaft. 19 p.
40062002 Ward, T. (1986) Static Acute Toxicity of MCPA (2-Methyl-4-chloro-
phenoxyacetic Acid) to the Atlantic Silverside (Menidia meni-
dia): ERGO Laboratory Project D0786. Unpublished study pre-
pared by ERCO/A Division of ENSECO Inc. 19 p.
40062003 Ward, T. (1986) Static Acute Toxicity of MCPA (2-Methyl-4-chloro-
phenoxyacetic Acid) to Embryos and Larvae of the Eastern Oyster,
Crassostrea virginica: ERCO Laboratory Project DO186. Unpub-
lished study prepared by ERCO/A Division of ENSECO Inc. 20 p.
40062005 Ward, T. (1986) Static Acute Toxicity of Technical MCPA Dimethyl-
amine Salt (2-Methyl-4-chlorophenoxyacetic Acid, Dimethylamine
Salt) to the Rainbow Trout, Salmo gairdneri: ERCO Laboratory
Project D1386. Unpublished study prepared by ERCO/A Division of
ENSECO Inc. 19 p.
40076201 Gushow, T.; Battjes, J.; Yano, B. (1987) Isooctyl Ester of 2-Me-
thyl-4-chlorophenoxyacetic Acid: An Acute Aerosol Inhalation
Study in Fischer 344 Rats: Study ID: DR-0075-4585-001. Unpub-
lished study prepared by Dow Chemical Co. 21 p.
40077101 Stevens, J. (1987) Nitrosamine Analysis: Weedestroy Triamine II:
Project No.: 5450-2556. Unpublished study prepared by Ther-
medics Inc. 13 p.
40169501 Cahoy, R. (1987) MM885 - Product Chemistry. Unpublished compila-
tion prepared by FBI/Gordon Corp. 7 p.
40169502 Goff, U. (1987) MM885: Formal Report of Analysis for N-Nitroso Com-
pounds: Proj. ID. 5450-2450. Unpublished study prepared by Th-
ermedics Inc. 15 p.
40171802 Goff, U. (1987) Trimec M 887 Liquid Weed & Feed 20-0-0: Formal Re-
port of Analysis for N-Nitroso Compounds: Laboratory Project ID:
5450-2461. Unpublished study prepared by Thermedics Inc. 20 p.
148
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered of the Data Base Supporting
Registrations Under the MCPA Standard
MRID Citation
0171902 Goff, U. (1987) Trimec M 886 Liquid Weed & Feed 20-0-0: Formal Re-
port of Analysis for N-nitroso Compounds: Laboratory Project ID:
5450-2461. Unpublished study prepared by Thermedics Inc. 20 p.
0212901 Christman, P. (1987) MCPA—Nitrosamine Content of Formulated Pro-
duct. Unpublished study prepared by Hazleton Laboratories
America. 21 p.
0282501 Poort, J. (1987) Product Chemistry Requirements...for MCPA Amine 4
Herbicide. Unpublished study prepared by Akzo Zout Chemie
Nederland. 23 p.
0306102 Stevens, J. (1987) Trimec M907 Liquid Weed & Feed: Formal Report
of Analysis for N-nitro Compounds: Lab Project ID: 5450-2815.
Unpublished study prepared by Thermedics Inc. 18 p.
0306502 Steven, J. (1987) MM 909 Liquid Weed & Feed: Formal Report of Ana-
lysis for N-Nitroso Compounds: Laboratory Project ID: 5450-2815.
Unpublished study prepared by Thermedics Inc. 18 p.
0314302 Goff, U. (1987) MM 893 Weed & Feed: Formal Report of Analysis for
N-Nitroso Compounds: Laboratory Project ID: 5450-2580. Unpub-
lished study prepared by Thermedics Inc. 18 p.
0314402 Goff, U. (1987) Trimec M 892 Weed & Feed: Formal Report of Analysis
for N-Nitroso Compounds: Lab Project ID: 5450-2580. Unpublished
study prepared by Thermedics Inc. 18 p.
0352001 Jeffery, M. (1987) MCP Ester Herbicide: Dermal Sensitization Poten-
tial in the Hartly Albino Guinea Pig: Project No. DR-0229-0699-
003. Unpublished study prepared by The Dow Chemical Co. 12 p.
0352101 Jeffrey, M. (1987) MCP Amine Herbicide: Dermal Sensitization Poten-
tial in the Hartley Albino Guinea Pig: Laboratory Project ID:
DR-0229-0702-003. Unpublished study prepared by Dow Chemical
Co. 13 p.
0461901 Obrist, J. (1987) Anaerobic Aquatic Metabolism of MCPA: Laboratory
Project ID: HLA 6015-325. Unpublished study prepared by Hazle-
ton Laboratories America, Inc. 75 p.
149
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered of the Data Base Supporting
Registrations Under the MCPA Standard
MRID Citation
40470101 May & Baker Ltd. (1987) Addendum to Product Chemistry Data Require-
ments Under EPA Pesticide Assessment Guidelines ...: 2-(4-chlo-
ro-2-methylphenoxy)acetic Acid, MCPA Technical: Lab. Proj. ID
ECD/JBU/LMC/2108. Unpublished study. 32 p.
40471801 Bailey, R.; Hopkins, D. (1987) 2-Methyl-4-chlorophenoxyacetic Acid:
Determination of Octanol/Water Partition Coefficient: Lab. Proj.
ID ES-DR-0004-9672-4. Unpublished study prepared by Dow Chemi-
cal Co. 13 p.
40471802 Hopkins, D. (1987) 2-Methyl-4-Chlorophenoxyacetic Acid: Determina-
tion of the Water Solubility: Lab. Proj. ID ES-DR-0004-9672-3.
Unpublished study prepared by Dow Chemical Co. 14 p.
40471803 Chakrabarti, A.; LaBean, M. (1985) Vapor Pressure of MCPA and Two
MCPA Esters: Lab. Proj. ID ML-AL-85-40005. Unpublished study
prepared by Dow Chemical Co. 13 p.
40513001 Sorensen, R.; Christensen, W.; Pedersen, M. (1987) KVK Herbatox
MCP: Preliminary Analysis and Analytical Methods to Verify Cer-
tified Limits: KVK-1988-1. Unpublished study prepared by Kemisk
Vaerk Koge A/S. 28 p.
40634101 Kirsch, P. (1986) Report: Study on the Chronic Toxicity and Onco-
genic Potential of MCPA in Rats: Final Report: Project No.
71S0046/8345. Unpublished study prepared by BASF Ag. 2026 p.
40792301 Kuhborth, B. (1986) Report: Study on the Oncogenic Potential of
MCPA in Mice: Project No. 80S0046/8358. Unpublished study
prepared by BASF AG. 1067 p.
150
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IV. FORMS APPENDICES
151
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Form Approved. OMB No. 2070-0057. Approval expires 11-30-89.
FIFKA SECTION 3(C)(2)(B) SUiVliVlAHY SHEET
EPA REGISTRATION NO.
PRODUCT NAME
APPLICANT'S NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "generic" data imposed by the FIFRA section 3(C)(2)(B) notice contained in the referenced
Guidance Document, I am responding in the following manner:
O 1. I will submit data in a timely manner to satisfy the following requirements. If the test procedures I will use deviate from (or are not
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group, OECD
Chemicals Testing Programme, I enclose the protocols that I will use:
I have entered into an agreement with one or more other registrants under FIFRA section 3(C)(2)(BMii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
Q 3. I enclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data" with
respect to the following data requirements:
CH 4. I request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
5. I request voluntary cancellation of the registration of this product. (This option is not available to applicants for new products.)
REGISTRANT'S AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
EPA Form 8580-1 (10-82)
-------
CMS Approval No. 2070-0057
Eviration Date 11/30/89
GENERIC IPQA EXEMTICN STKEEMNT
HA Product Registration Number:
Registrant's IferE and ?ddress:
As an authorized representative of the registrant of the product identified above, I
certify that:
(1) I have read and am familiar with the terms of the Notice fron EEft. dated
ocrcerning a requirement for submission of "generic" data on the active
ingredient named under FTFRA. secticn 3(c) (2) (B).
(2) Mf firm requests that EIA not suspend the registration of our product, despite
our lack of intent to submit the generic data in question, on the grounds that the product
contains the active ingredient solely as the result of the incorporation into the product
of another product viiich ocntains that active ingredient, which is registered under FTFRA.
Secticn 3, and viiich is purchased by us from another producer.
(3) An accurate Gcnfidental Stataient of Formula (CSF) for the above-identified
product is attached to this statement. That formula statanent indicates, by company naroe,
registration number, and product name, the source of the subject active ingredient .in my
firm's product, or
The CSF dated on file with EFA is complete, current and accurate and
contains the informaticn requested on the current CSF Form 8570-4. Ore registered
source(s) of the above named active ingredient in my product(s) is/are
and their registration number(s) is/are .
^ firm win apply for an amendment to the registration prior to changing the source
of the active ingredient in our product.
(4) I understand, and agree on behalf of my firm, that if at any time any portion of
this Statement is no longer true, or if my firm fails to comply with the undertakings made
in this Statanent, my firm's product's registraticn may be suspended under FTFRA section
3(c)(2)(B).
(5) I further understand that if my firm is granted a generic cigt-a exemption for the
product, my firm relies on the efforts of other persons to provide the Agency with the
required generic data. If the registrant(s) *4r> have comtitted to generate and submit the
required data fail to take appropriate steps to meet requirements or are no longer in
oorpliance with this Notice's rfrfra requirements, the Agency win consider that both they
and my firm are not in compliance and win normany initiate proceedings to suspend the
registrations of my firm's prcduct(s) and their product(s), unless my firm Gamuts to
submit and submits the required data in the specified time frame. I understand that, in
such cases, the Agency generany win not grant a time extension for submitting the data.
Registrant's authorized representative:
(Signature
Dated;
FJEA Form 8570-27
153
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US Environmental Protection Agency Registration Standard for:
Washington, DC 20460
V>EPA Product Specific
Data Report
Registration
Guideline No.
Sec. 158.120
Product
Chemistry
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
83-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
Sec. 158.135
Toxicology
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
Identity of Ingredients
Statement of composition
Discussion of formation of ingredients '
Preliminary analysis
Certification of limits
Analytical methods for enforcement limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-density, or specific gravity
Solubility
Vapor pressure
Dissociation constant
Octanol/watef partition coefficient
PH
Stability
Oxidizing/reducing reaction
Rammability
Explodability
Storage stability
Viscosity
Mistibility
Corrosion Characteristics
Dielectric breakdown voltage
Acute oral toxicity, rat
Acute dermal toxicity, rabbit
Acute inhalation toxicity, rat
Primary «y» irritation, rabbit
Primary dermal irritation
Dermal saosrtrzation
Testing not
required for my
product listed
above
(Check below)
EPA Registration Number
1 am complying with
Data Requirements by -
Citing MR ID No.
Submitting Data
(Attached)
(Check below)
Form Approved
OMB #2070-0057
Expires 11-30-89
(For EPA Use
Only)
Accession
numbers
assigned
.« »
Certification
I certify that the statements I have made on this form and all attachments thereto are
true, accurate, and complete. I acknowledge that any knowingly false or misleading
statement may be punishable by fine or imprisonment or both under applicable law.
Typed Nam* and Title
Signature
Date
tPA Form B58O-4 (Hev. 5-88) previous edition is obsolete.
154
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Poem Approxd. OMB No. 2070-OOS7. gxptm* 11-a
(To qualify, certjfy Ł**'*four items)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I am duly authorized to represent the following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(c){2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
NAME OF FIRM
.„
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
EPA COMPANY NUMBER
(This firm or group of firms is referred to below as "my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to e
into an agreement with one or more other registrants to develop jointly, or to share i;i ihe cost of developing, the following requ
.ten-i, rr data:
3. My firm has offered in writing to enter into such an agreement Copies of the offers are attached. That offer was irrevocable and included an offer
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all terms could not be reached otherwise. This offer was
to the following firm(s) on the following date(s):
NAME OF FIRM
DATE OF OFFER
However, none of those firm(s) accepted my offer.
4. My firm requests that EPA not suspend the registration(s) of my firm's product(s), if any of the firms named in paragraph (3)
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly ir
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This stat<
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
SIGNATURE
DATE
EPA Form 8580-6 (1042)
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