&EPA
UniMdSutM
EnvirofiiMntai Prottetion
Agency
Off to* of
PMteidw and Toxic
Washington DC 20460
PMicidM
Guidance for the
Reregistration of
Pesticide Products
Containing PICLORAM
as the Active Ingredient
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GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
Picloram
AS THE ACTIVE INGREDIENT
OPP Number: 005101
CAS Number: 1918-02-1
September 30, 1988
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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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 6
A. Summary Science Statement
B. Toxicological Characteristics
C. Manufacturing Impurities
D. Physiological and Biochemical Behavioral
Characteristics
E. Environmental Characteristics
F. Groundwater Contamination
G. Exposure and Reentry
H. Ecological Characteristics
I. Product Chemistry
J. Pesticide Incident Reports
k. Tolerance Assessment
IV. Regulatory Position and Rationale 29
A. Regulatory Positions
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard 42
VI. Requirement for Submittal of Generic Data 44
A. What are generic data? 44
B. Who must submit generic data? 44
C. What generic data must be submitted? 45
D. How to comply with DCI requirements 45
E. Registrant Requests Regarding Data
Requirements and Agency Responses 47
F. Test Protocols and Standards 48
G. Procedures for requesting a change in protocol. .
H. Procedures for requesting extensions of time. . .49
I. Data Format and Reporting Requirements 49
J. Existing stocks provisions upon suspension or
cancellation 49
VII. Requirement for Submittal of Product-Specific Data . .51
VIII. Requirement for Submittal of Revised Labeling 52
IX. Instructions for Submittal 53
A. Manufacturing use products (sole active)
B. Manufacturing use products (multiple active)
C. End use products (sole active)
D. End use products (multiple active)
E. Intrastate products
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I. DATA APPENDICES .................... 56
Guide to Tables
Table A
Table B
II. LABELING APPENDICES
Summary of label requirements and table
40 CFR 156.10 Labeling Requirements
Physical/Chemical Hazards Labeling Statements
Storage Instructions
Pesticide Disposal Instructions
Container Disposal Instructions
III. BIBLIOGRAPHY APPENDICES ................ 127
Guide to Bibliography
Bibliography
IV. FORMS APPENDICES .................... 141
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
11
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GLOSSARY OF TERMS AND ABBREVIATIONS
1985 Standard
ae
ai
CAS
CSF
EC
EEC
EP
EPA
FIFRA
FWS
gal
g/kg
GSRI
HCB
HDT
IOE
IPA
K
LOT
LEL
LOEL
MATC
Registration Standard issued March 29, 1985
for Picloram
Acid equivalent
Active ingredient
Chemical Abstracts Service (Number)
Confidential Statement of Formula
Emulsifiable concentrate
Estimated Environmental Concentration
End-use product
The Environmental Protection Agency, also
"the Agency"
The Federal Insecticide, Fungicide, and
Rodenticide Act
Fish and Wildlife Service
Gallon
Grams per kilogram
Gulf South Research Institute
Hexachlorobenzene
Highest dose tested
Isooctyl ester of picloram
Isopropanolamine salt of picloram
Potassium salt of picloram
Lowest dose tested
Lowest-effect level
Lowest-observable-effect level
Maximum allowable toxic concentration
111
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mg/kg bwt/day
mg/L
MP
MRID
NOEL
NPDES
NTP
OPP
PADI
picloram
ppb
ppm
Ql*
RAC
R.F.D.
SC/L
Supplementary
Data
TEA
TIPA
TGAI or
Technical
Milligrams per kilogram of body weight
per day
Milligrams per liter
Manufacturing-Use product
Master Record Identification (Number) - EPA's
system of tracking studies used in support
of registration
No-observed-effect level
National Pollution Discharge Elimination System
National Toxicology Program
The Office of Pesticide Programs
Provisional acceptable daily intake
4-amino-3,5,6-trichloropicolinic acid
Parts per billion
Parts per million
Potency
Raw agricultural commodity
Considered to be the level unlikely to cause
significant adverse health effects associated
with a threshold mechanism of action in humans
exposed to a toxicant for a lifetime.
Soluble concentrate/liquid
Studies in this category maybe scientifically
sound, thus the information may be useful.
However, the studies were performed under
conditions that deviated substantially from
recommended protocols. These studies do not
meet Guideline requirements and thus do not
support registration of a product.
Triethylamine salt of picloram
Triisopropanolamine salt of picloram
Technical grade of the active ingredient
IV
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Technical
Picloram Technical grade of picloram or the acid
form of picloram
TMRC Theoretical Maximum Residue Contribution
TWA Time-weighted averages
> Greater than
< Less than
v
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I. INTRODUCTION
This document is a revised Registration Standard for
the subject chemical. In its original Standard, issued on
March 31, 1985/ the Agency described the available data
supporting the registration of the chemical. The Agency
concluded that additional data were necessary to fully
evaluate the pesticide. The Agency also set out label lang-
uage which the Agency concluded at that time were needed to
ensure that products containing the pesticide remained in
compliance with FIFRA.
The Agency has since received and reviewed the additional
data and has revised its scientific and regulatory conclusions
in light of those data, other information on the chemical,
and expanded data requirements promulgated in 1984, at 40 CFR
Part 158, for registration and reregistration of pesticides
under FIFRA.
This revised Registration, which supersedes the earlier
Standard, is the Agency's updated scientific assessment of
the pesticide, and the data needed to support its continued
registration. The Agency has also reassessed the tolerances
for the pesticide; that reassessment is included in this
Registration Standard.
The Agency has also reviewed the current labeling for
products containing the pesticide, and has specified label
revisions which are necessary to remain in compliance with
FIFRA.
The detailed scientific review, which is not contained
in this document, but is available upon request1, focuses on
the pesticide active ingredient. The scientific review pri-
marily discusses the Agency's evaluation of and conclusions
from available data in its files pertaining to the pesticide
active ingredient. However, during the review of these data
the Agency is also looking for potential hazards that may be
associated with the end use products that contain the active
ingredient. The Agency will apply the provisions of this
Registration Standard to end use products if necessary to
protect man and the environment.
EPA's reassessment results in the development of a
regulatory position, contained in this Registration Standard,
on the pesticide and each of its registered uses. See
Section IV - Regulatory Position and Rationale. Based on its
regulatory position, the Agency may prescribe a variety of
1-The scientific reviews and Compendium of Uses may be obtained
from the National Technical Information Service (NTIS),
Attn: order Desk, 5285 Port Royal Road, Springfield, VA
22616. Tel: (703) 487-4650.
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steps to be taken by registrants to maintain their registrations
in compliance with FIFRA. These steps may include:
1. Submission of data in support of product registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in
the issuance of a Notice of Intent to cancel or a Notice of
Intent to Suspend (in the case of failure to submit data).
In addition, in cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154
to examine in depth the risks and benefits of use of the
pesticide. If the Agency determines that the risks of the
pesticide's use outweigh the benefits of use, the Agency
may propose additional regulatory actions, such as cancellation
of uses of the pesticide which have been determined to cause
unreasonable adverse effects on the environment.
EPA has authority under the Data call-in (DCI) provisions
of FIFRA sec. 3(c)(2)(B) to require that registrants submit
data to answer our questions regarding the chemical, toxicological,
and environmental characteristics and fate of a pesticide.
This Registration Standard lists the data EPA believes are
necessary to resolve our concerns about this pesticide.
These data are listed in the Tables A, B, and C in Appendix I.
Failure to comply with the DCI requirements enumerated in
this Registration Standard may result in issuance by EPA of a
Notice of Intent to Suspend the affected product registrations.
Registrants are reminded that FIFRA sec. 6(a)(2) requires
them to submit factual information concerning possible unreason-
able adverse effects of a pesticide at any time that they
become aware of such information. Registrants must notify
the Agency of any information, including interim or preliminary
results of studies, if that information suggests possible
adverse effects on man or the environment. This requirement
is independent of the specific time requirements imposed by
EPA for submission of completed studies called in by the
Agency and continues as long as the products are registered
under FIFRA.
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II. CHEMICALS COVERED BY THIS STANDARD
A. DESCRIPTION OF CHEMICALS
The following chemicals are covered by this Registration
Standard:
Chemical Name: 4-amino-3 ,5,6-trichloropicolinic acid
Common Name: Picloram
CAS No.: 1918-02-1
OPP Chemical Code: 005101
Empirical Formula: CgH3Cl3N202
Trade Name: Tordon
Chemical Characteristics: White powder which decomposes
at 215 °C, bulk density of 19.7 pounds per cubic foot
(Ib/cu ft)
Chemical Name: Potassium salt of 4-amino-3 , 5 ,6-tri-
chloropicolinic acid
Common Name: Picloram potassium (K) salt
CAS No.: 2545-60-0
OPP Chemical Code: 005104
Empirical Formula: C6H2C13KN202
Chemical Name: Isooctyl ester of 4-amino-3 , 5,6-tri-
chloropicolinic acid
Common Name: Picloram isooctyl ester (IOE)
OPP Shaughnessy No.: 005103
Empirical Formula:
Chemical Name: Tri isopropanolamine salt of 4-amino
3 ,5 ,6-trichloropicolinic acid
Common Name: Picloram TIPA salt
OPP Chemical Code: 005102
Empirical Formula:
Chemical Name: Triethylamine salt of 4-amino-3,5,6
trichloropicolinic acid
Common Name: Picloram TEA salt
OPP Chemical Code: 005105
Empirical Formula:
Chemical Name: Isopropanolamine salt of 4-amino-3 , 5,6
trichloropicolinic acid
Common Name: IPA salt of picloram
B. USE PROFILE
Type of Pesticide: Herbicide
Pests Controlled: Broadleaf weeds and woody plants
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Registered Uses: Picloram, potassium salt: Terrestrial food
crop use on small grains (spring barley,
spring oats, spring and winter wheat),
flax, pastures and rangeland grasses;
Terrestrial nonfood use on noncrop agri-
cultural areas and rights-of-way; Fore stry
use on forest lands site preparation.
Picloram, isooctyl ester: Terrestrial nonfood
use on industrial sites (manufacturing
sites, storage areas, and fencerows) and
rights-of-way. Forestry use on forest
trees site preparation.
Picloram, triisopropanolamine salt:
Terrestrial food crop use on small grains
(spring barley, spring and winter wheat),
pastures, and rangeland. Terrestrial non-
food crop use on uncultivated agricultural
areas, rights-of-way, and industrial sites
(manufacturing and storage areas); Aquatic
nonfood crop use on drainage ditchbanks;
Forestry use on forest trees.
Picloram triethylamine salt: Terrestrial
food crop use on pastures and rangeland.
Predominant Uses: Pasture and rangeland (57%), utility rights-
of-way (29%), and forestry (13%).
Mode of Activity: Alters nucleic acid and protein
synthesis
Formulations: (Represented Sec. 3 registrations of the potassium
salt (K). Formulation Intermediate: 30% ae or
34.7% active ingredient (ae).
Pelleted: 2% ae or 2.3 ai, 5 ae or 5.8% ai, 10% ae
or 11.6 ai, Soluble Concentrate, Liquid: 2 Ib ae,
or 24 ai, 24.4 ai, or 24.9% ai.
Basic Manufacturer: Dow Chemical USA
Year of Initial Registration: 1964
Methods of Application: By Ground; Broadcast or spot
treatment as foliar or soil
spray; as a basal spot treat-
ment; broadcast as pelleted,
spray, as tree injection, as
frill treatment, as stump treat-
ment, as basal bark treatment,
as a wick application, and as
low-volume dormant stem spray.
By Air; Broadcast or low volume
dormant spray.
Rates of Application: (Section 3 registrations) Picloram,
TIPA salt: 0.27 to 3.00 Ib ae/A.
Picloram, IDE: 0.5 to 3.0 Ib ae/A
(mixtures or MAI).
Picloram, K salt: 1.0 to 8.50 Ib
ae/A.
Picloram, TEA salt: 0.25 to 1.0 Ib
ae/A (SLN's).
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C. HISTORY
Picloram, 4-amino-3,5,6-trichloropicolinic acid, is a systemic
herbicide registered for brush and broadleaf weed control. In
1978 the Agency classified picloram as a Restricted Use pesticide
based on hazard to nontarget organisms (specifically nontarget
plants both crop and noncrop). Considerable emphasis for restric-
tion was based on recurring reports of phytotoxicity to such
economically important crops as tomatoes, potatoes, tobacco,
and succulent ornamentals caused by contaminated water supplies
(1 part per billion [ppb]) range. This action was taken by the
Agency through regulations proposed in the September 1, 1977 (42
FR 44170) and finalized in the February 9, 1978 (43 FR 5782)
issues Of the FEDERAL REGISTER.
On March 29, 1985, the Agency issued a Registration Standard
for picloram. The Standard required the following: 1) precau-
tionary label statements advising against the use of picloram in
very permeable, i.e., well-drained soils such as karst limestone
and loamy sands; 2) a groundwater monitoring study; 3) retention
of Restricted Use classification; 4) additional wildlife testing
on the technical; 5) a field monitoring study to determine con-
centrations of picloram in runoff water and sediment, leachate,
groundwater, and in water and sediment of receiving aquifers to
complete a hazard evaluation to wildlife; 6) development of
analytical methods for metabolite residues in plant and animal
samples; 7) storage stability data; 8) additional oncogenicity
data; 9) limiting the level of hexachlorobenzene (HCB) in the
technical to a maximum of 200 parts per million (ppm); 9) nontar-
get area phytotoxicity data on the technical; and 10) testing for
nitrosamines and certification that the upper limit of nitrosamines
occurring in the technical is not greater than 1 ppm.
The Standard concluded that reentry intervals were not required;
that all forms (acid, esters, amines) were toxicologically similar,
therefore, testing with the acid form would fulfill most data
requirements for all forms; and that adequate residue data were
not available to support established tolerances. Additional data
required by the Standard included acute toxicology studies on the
various forms of picloram, chronic feeding studies, oncogenicity
data on the rat, a rabbit teratology study, avian oral and dietary
studies, phytotoxicity studies, additional residue data, and
additional environmental fate data.
All data submitted in response to the Standard have been
reviewed and evaluated and previously submitted data have been
reevaluated. The results of this review are discussed in the
Agency Assessment section.
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III. AGENCY ASSESSMENT
A. SUMMARY SCIENCE ASSESSMENT
Technical picloram is in Toxicity Category I with respect to
acute inhalation and Categories III and IV with respect to other
acute toxicities. Picloram has been classified as a Group D
oncogen (not classifiable to human carcinogenicity). Available
supplemental data indicate that picloram is not teratogenic to
rats and causes no adverse reproductive effects. Repeat oncogen-
icity, teratology, and reproduction studies are being requested.
Picloram appears not to be mutagenic based on available data.
Picloram is stable to hydrolysis, does not photodegrade under
light, and is relatively stable in anaerobic loam soils and under
anaerobic aquatic conditions. It also does not accumulate in
fish, picloram was intermediately to very mobile in soils ranging
in texture from clay to loam. Picloram has been identified as a
chemical with a potential to contaminate groundwater.
Picloram is practically nontoxic to avian species, slightly
to moderately toxic to freshwater fish, and slightly toxic to
freshwater invertebrates.
B. TOXICOLOGICAL CHARACTERISTICS
The Agency has registered several forms of picloram: the
potassium (K) salt, the isooctyl ester (IOE), triisopropanolamine
(TIPA) salt, and the triethylamine (TEA) salt. The isopropanol-
amine (IPA) salt of picloram and the acid form currently have no
registered uses. In the 1985 Standard, the Agency considered the
different forms of picloram to be toxicologically similar and
required testing on the acid form to fulfill data requirements
for all forms of picloram. Because there may be qualitative or
quanitative difference in the behavior of the TEA, TIPA, IPA salts
due to the amine moiety and the IOE due to the ester moiety and be-
cause either moiety may cause effects not seen with the acid or K
salt a separate set of toxicology studies are required for the
isoctyl esters and the amine salts. Therefore, for the purposes
of this Standard, the acid and K salt forms are expected to act
similarly and, lacking data to show otherwise, the organic ester
and amines may be expected to have different qualitative and/or
quantitative toxicological properties than the acid and the K salt
and from each other.
Considering the common moiety, picloram, in each compound, the
Agency is requiring complete toxicological testing of the acid and/
or K salt. The Agency lacks basic toxicology (acute and subchronic
feeding, mutagenicity, and teratology) data on the organic esters
and amines of picloram. To evaluate applicator risk and to deter-
mine if the toxicity of these organic amines and esters differ
significantly from the acid and each other, acute toxicology, sub-
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chronic feeding, teratology, and mutagenicity studies are required
for the organic salts (TIPA, TEA, IPA) and extra forms of picloram.
Refer to the discussion below and the data tables in Appendix I
for specific requirements.
Acute Toxicology
An acute inhalation study places technical picloram acid in
Toxicity Category I with an acute inhalation toxicity of 0.035
mg/L. Acute oral toxicity (females), acute dermal toxicity, and
primary eye irritation studies place technical picloram acid in
Toxicity Category III with an acute oral toxicity for females of
4012 mg/kg; an acute dermal toxicity > 2000 mg/kg, and moderate
eye irritation. Primary dermal irritation and acute oral toxicity
(males) studies place technical picloram in Toxicity Category IV
with an acute oral toxicity to males > 5000 mg/kg and no erythema
or edema observed in the primary dermal irritation study. Tech-
nical picloram was not a skin sensitizer in the dermal sensitization
study.
An acute inhalation study places the K salt formulation
intermediate in Toxicity Category II with an acute inhalation
toxicity greater than 1.63 mg/L. Acute oral toxicity (females),
acute dermal, and primary eye irritation studies place the K salt
in Toxicity Category III with an acute oral toxicity to females
of 3536 mg/kg; an acute dermal toxicity > 2000 mg/kg, and moderate
eye irritation. Primary dermal irritation and acute oral toxicity
(males) studies place the K salt in Toxicity Category IV with an
acute oral toxicity to males > 5000 mg/kg and no erythema or
edema observed in the primary dermal irritation study. A dermal
sensitization study showed that the K salt form of picloram was a
skin sensitizer.
An acute inhalation study places the IOE form of picloram in
Toxicity Category II with an acute inhalation toxicity > 0.35
mg/L. Acute oral toxicity, acute dermal toxicity, eye irritation,
and dermal irritation studies place the IOE form of picloram in
Toxicity Category III with mild skin irritation, moderate eye
irritation, an acute oral toxicity > 3500 mg/kg (males and females),
and an acute dermal toxicity > 2000 mg/kg. A dermal sensitization
study showed that the IOE form of picloram was a skin sensitizer.
There are no acute toxicology data available for the TIPA,
TEA, or IPA salts of picloram. These data are required.
Subchronic Toxicity
An acceptable 13-week subchronic feeding of technical picloram
acid study in rats fed dosages of 0, 15, 50, 150, 300, or 500 mg/kg
has been submitted. A dose-dependent increase in absolute and rela-
tive liver weights was seen at 150 mg/kg. Effects were minimal and
showed a NOEL of 50 mg/kg.
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An acceptable 6-month feeding study with dogs fed dosages of
0, 7, 35, or 175 mg/kg/day of technical picloram acid has been
submitted. A decrease in food consumption and increases in
liver weights at the highest dose and increased liver weights
were noted in males at 35 mg/kg (lowest effect level [LEL])
resulting in a NOEL of 7 mg/kg.
No subchronic feeding studies are available for the TIPA,
TEA, IDE, or IPA forms of picloram. Subchronic feeding studies
in a rodent and a nonrodent are required for each form of picloram.
No data are available on the 21-day subchronic dermal toxicity
of picloram. This was not a data requirement in the 1985 Standard
because the toxicology review was completed before the 1984 Guide-
lines were finalized which require a 21-day dermal study when
dermal exposure is estimated to be of limited frequency and
duration. Therefore, because existing use patterns may result
in limited exposures of short duration, a 21-day dermal study is
required for picloram acid (or K salt), the TIPA, IPA, TEA, and
IDE forms of picloram.
No data are available on the 90-day subchronic dermal toxicity
of picloram. A study is not required because existing use patterns
do not involve purposeful or prolonged dermal exposure (not used on
clothing or in swimming pools).
No data are available on the 90-day subchronic inhalation
toxicity of picloram. A study is not required because the present
use patterns do not result in repeated inhalation exposure (not
used on tobacco).
Neurotoxicity
There are no data available for acute delayed or subchronic
delayed neurotoxicity for either picloram or its salts, esters,
and amines. Acute delayed neurotoxicity studies are not required
because picloram and its salts, esters, or amines are not organo-
phosphates. Subchronic delayed neurotoxicity testing is not
required because acute delayed neurotoxicity testing is not
required.
Chronic Toxicity
A acceptable 2-year chronic feeding study with rats fed
dosages of 20, 60, or 200 mg/kg/day of technical picloram has
been submitted. A significant dose-related histologically deter-
mined increase in size and altered tinctorial properties of
centrilobular hepatocytes occurred in both males and females at
60 and 200 mg/kg/day. The NOEL for this study is 20 mg/kg day.
This study is acceptable and satisfies the requirement of a
chronic feeding study in a rodent.
8
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A chronic feeding study for nonrodents was required by the
1985 Standard. This study was not submitted in time to be in-
cluded in standard.
Oncoqenicity
Available oncogenicity data for picloram include rat and
mouse studies performed by the National Toxicology Program (NTP)
and a rat study performed by Dow Chemical Company. These studies
are discussed below.
In a study performed by the NTP by Gulf South Research Institute
(GSRI), Osborne-Mendel rats were fed picloram (technical grade
90% pure with 130 ppm HCB) at dosages corresponding to time
weighted average (TWA) dosages of 372 mg/kg/day (7437 ppm) and
747 mg/kg/day (14,875 ppm) for 80 weeks. At the highest dose,
747 mg/kg/day, an oncogenic effect (neoplastic nodules) was seen
in females. This study was classified as supplementary data for
the following reasons: the matched control group was of insuffi-
cient size, a shorter than 2-year (lifetime) exposure limit was
used, and insufficient data and information were provided by
available chronic and subchronic studies to determine if a maximum
tolerated dose (MTD) was attained at 747 mg/kg/day.
In a second NTP study,. B6C3Fi mice were fed picloram (tech-
nical grade 90% pure with 130 ppm HCB) at dosages of 357 and 714
mg/kg/day for 79 weeks and allowed to recover 10 weeks prior to
sacrifice. Picloram did not show an oncogenic response up to 714
mg/kg/day for 79 weeks. This study initally considered acceptable
is classified as supplementary data because available information
do not assure that an MTD was attained in this study.
In a study submitted by Dow in response to the 1985 Standard,
Fisher 344 rats were fed doses of 0, 20, 60, and 200 mg/kg/day
picloram (technical grade 93% pure with 197 ppm of HCB) for 2
years. No dose-related oncogenic effects were observed in either
male or female rats. This study was initially classified as an
acceptable study. However, upon rereview, it was determined inade-
quate for determining the potential oncogenicity of picloram to
rats (MTD not determined, testing must be conducted on technical
picloram uncontaminated by HCB).
In its evaluation, the Agency notes that the above studies
have problems related to experimental design and good laboratory
practices (GLP) issues, dosing concerns (some of the studies appeared
to be conducted using inadequately low doses), and the presence of
the contaminant HCB in the technical grade picloram. HCB has been
known to produce liver tumors in some strains of rodents. As
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a result, EPA classified picloram as a Group D oncogen (not
classifiable as to human carcinogenicity) based on the EPA Guide-
lines and the weight of the following two biological evidence
considerations: First, although an oncogenic effect considered
to be "equivocal evidence" of carcinogenicity by the NTP was
seen at the highest dose level tested in one sex of one species
(liver adenomas/carcinomas combined in female Osborne-Mendel
rats) the presence of relatively high levels of HCB in technical
grade picloram was suspected to be responsible for the occurrence
of the liver tumors. EPA was informed that these levels are
greater than those found in commercially marketed picloram. The
study was further confounded because of inadequate dosage levels,
duration of exposure and control group, and possible GLP deficiencies.
Second, bioassays in B6C3Fi mice and in a second strain of rat
(Fischer 344) were negative for oncogenicity, but were considered
inadequate for determining the potential oncogenicity of picloram
because of similar confounding factors.
The Agency believes that the chronic rodent oncogenicity studies
of picloram contained major qualitative/quantitative limitations and
could not be accurately interpreted as showing either the presence
or absence of an oncogenic effect. The absence of a positive onco-
genicity correlation from two structurally similar pesticides, and
generally negative findings from short-term mutagenicity studies,
were also noted.
Because of the deficiencies in the picloram oncogenicity studies,
long-term studies in Osborne-Mendel rats and BgC3F} mice of both
sexes, conducted according to EPA Guidelines and the EPA Position
Paper on the MTD using commercially available technical grade piclo-
ram uncontaminated with potentially tumorigenic levels of HCB, are
required.
No oncogenicity data are available for the ester or amines of
picloram and studies are not required at this time pending submis-
sion and review of acute toxicology studies, subchronic toxicology,
and teratology studies required by this document (refer to data
tables in Appendix I for detailed requirements for the ester and
amine forms of picloram).
Teratogenicity
Available teratology studies for picloram include a rabbit
teratology, submitted in response to the 1985 standard and a rat
teratology study. These studies are discussed below.
A teratology study in rabbits using the K salt of picloram,
dosed by gavage at 0, 40, 200, or 400 mg/kg, showed that the
maternal LEL was 200 mg/kg and the maternal NOEL was 40 mg/kg
based on reduced body weight gain during gestation. Fetal
abnormalites (severe rib fixture or missing ribs, hypoplastic
10
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tail, omphalocele) were noted at 200 and 400 mg/kg. Historical
control data were not presented in this study and are needed to
evaluate the observed fetal abnormalities. Therefore, to fulfill
this requirement, the historical control data or a new study with
rabbits must be submitted.
In the 1985 Standard, the Agency concluded that a study in
which rats were dosed with 500, 750, or 1000 mg/kg was adequate
to show that picloram did not produce a teratogenic effect at up
to 1000 mg/kg/day. The review for that standard was completed
before finalization of 1984 Guidelines (October 24, 1984, 49 FR
42856). Upon reevaluation in accordance with the revised guide-
lines, some fetotoxicity (increased incidence of delayed ossifi-
cation of 5th sternebrae) was noted. No NOEL for fetotoxicity
was found. Maternal toxicity was also noted at 750 and 1000
mg/kg as hyperactivity and mild diarrhea. A repeat teratology
study in the rat is required.
No teratology studies are available for the esters or amines
of picloram. Therefore, teratology studies in rat and rabbits
are required for all the esters and amines of picloram.
Reproduction
A multigeneration reproduction study in rats fed dosages of
0, 1.5, 50, and 150 mg/kg/day was previously submitted and deter-
mined acceptable in the 1985 Standard. No reproductive effects
were observed. The review of this study was completed before
finalization of the 1984 Guidelines (October 24, 1984 49 FR 42856),
Upon reevaluation of this study under the 1984 Guidelines, this
study is now classified as supplementary data because too few test
animals were used and no toxicity was observed at the highest
dose tested. Therefore, a 2-generation reproduction study with
rats is required for picloram.
No reproduction studies are available for the esters and
amines of picloram and none are required at this time pending
submission and review of acute toxicology, subchronic toxicology,
and teratology studies requested by this document (refer to data
tables in Appendix I for detailed requirements of the ester and
amine forms of picloram).
Mutaqenicity
An Ames test was submitted in response to the 1985 standard
testing picloram with Salmonella typhimurium with and without
activation. Based on qualitative statements, picloram did not
produce mutagenic effects. This study is classified as supple-
11
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mentary data since only qualitative statements were submitted.
Therefore, a new study is required or the data and raw report
materials must be submitted for the study on hand.
A cytogenetic (bone marrow cells) study in rats exposed to
single doses up to 2000 mg/kg picloram did not show evidence of
chromosomal changes. This study satisfies the requirement for
chromosomal aberrations for technical picloram.
No data are available on the evaluation of the direct DNA-
damaging potential of picloram. These data are required for
technical picloram (or its K salt), its amines, and esters.
Data are required to satisfy requirements for gene mutation
and chromosomal aberrations for all esters and amines of picloram.
Metabolism
A metabolism study using only male rats is available for
picloram. Three male rats were dosed orally with 1.634, 9.6,
or 184 mg/kg. The three rats gave mean excretion values of 82.28
_+ 2.78 percent of the dose in urine, 15.52 +_ 2.04 percent of the
dose in feces, < 0.0006 percent of the dose in C02, and 0.57 +.
0.18 percent in cage washings; for a total of 98.37 +_ 1.21 percent
recovered after 72 hours. This study alone does not satisfy the
requirement since testing was not on both sexes as required by
the 1984 Guidelines. An additional study in female rats is re-
quired for technical picloram (or the K salt). Data are required
for all esters and amines of picloram in both male and female
rats.
C. MANUFACTURING IMPURITIES
1. Hexachlorobenzene
Technical picloram contains the impurity HCB, at a
maximum of 200 ppm. Because HCB is classified as a Probable
Carcinogen (Group B2), a dietary risk assessment was included
in the 1985 Standard. This assessment estimated the risk in
the fat and milk of cattle fed picloram treated grass to be
4.6 x 10~8 for a 70 kg adult and 1.4 x 10~7 for a 10 kg child
This assessment has been updated and is discussed below.
12
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Hazard Profile of HCB in Pi dor am
Oncoqenic Effects
In January 1985, the Agency published a Health Assessment
Document for Chlorinated Benzenes (MRID No. 405430-01).** The
conclusions from that document were used to perform the following
risk assessment. A brief summary of the qualitative and quantita-
tive oncogenic assessment from that document is presented below.
For an in-depth discussion, refer to Section 12 of the document.
Assuming that HCB is oncogenic in humans, the Agency
estimated an upper-bound incremental unit cancer risk. Four
animal studies were adequate for use in estimating the Q±* (i.e.,
potency).
Fourteen data sets which show significant increases of
tumor incidences were used to calculate the carcinogenic potency
of HCB. These include hepatomas and hemangioendothelioma of the
liver in both sexes and thyroid adenomas in male Syrian golden
hamsters (Cabral et al., 1977), hepatomas in both sexes in Swiss
mice (Cabral et al., 1979), renal cell adenoma, hepatocellular
carcinoma, and hepatoma in both sexes of Sprague-Dawley rats
(Lambrecht 1983) and adrenal pheochromocytoma in female Sprague-
Dawley rats (Arnold et al., 1985). The QI* obtained from the
hepatocellular carcinomas in the female Sprague-Dawley rats was
used to calculate the cancer unit risk and is used to calculate
the risk as a result of exposure to HCB from the uses of pesticide
products containing picloram. The estimate of greatest potency
was determined to be:
Qx* = 1.7 (mg/kg/day)
-1
** 40543001 U.S. Environmental Protection Agency (1984)
Health Effects Assessment for Hexachlorobenzene: EPA/
54C/186-C17). Prepared by Syracuse Research Corp., under
EPA Contract 68-03-3112, for the Office of Solid Waste
and Emergency Response, Washington, D.C. 43 pages.
13
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Other Toxic Effects
A 4-generation reproductive toxicity study of HCB in rats
produced a NOEL of 20 ppm (1 mg/kg/day). The primary toxic
effect observed was toxicity to the nursing pups. The effect was
lethal at higher doses. No teratogenic effects were seen. The
NOEL for maternal toxicity was 80 ppm (4 mg/kg/day).
Risks from Dietary Exposure
Potential dietary exposures to the impurity HCB may occur
from the use of pesticides containing picloram on small grains
and secondary residues on animal commodities resulting from use
on pastures and rangeland. Tolerances for picloram do not include
allowable residues for HCB. Because there are no actual crop
residue data for HCB, estimates of potential dietary exposures to
it from picloram use were calculated using picloram tolerance
levels. The Agency is requiring analyses for residues of HCB in
or on agricultural commodities derived from crops treated with
pesticides containing picloram.
In estimating dietary exposures, it was assumed that
residues of HCB would be present at 0.02 percent of picloram
tolerance levels, the maximum legal level of HCB contamination in
technical picloram and that 100 percent of the crops would be
treated with picloram.
Based on available information, oncogenic risk was estimated
for the overall .U.S. population in accordance with current Agency
policy. This value was calculated by the relationship:
Risk = Exposure x QI*
Risk = 3.67 x 10~7 mg/kg/day x 1.7 (mg/kg/day)-1
Risk = 6 x 10.-7
Risks from Nondietary Exposure
Potential nondietary exposure to HCB is to workers, mixer-
loaders, and applicators from uses of picloram on wheat, forests,
rights-of ways, and pasture/rangeland. To estimate worker exposure,
the following assumptions were made: technical picloram is assumed
to contain 200 ppm of HCB; an average worker weighs 70 kg; a ground
14
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applicator treats 100 acres of wheat per day at a rate of 0.02
Ib ae/A with an actual treatment time of 6.0 hours; private
applicators are assumed to work 3 days/year and commercial appli-
cators 15 days/year; an aerial applicator treats 600 acres of
pasture/rangeland per day with picloram at a typical rate of 0.5
Ib ae/A and a maximum rate of 4.0 Ib/A (actual treatment time
is 7.5 hours/day); workers are assumed to spend 10 days/year
treating pasture/rangeland; for aerial application, separate
individuals perform mixer/loader, flagger, and applicator (pilot)
tasks.
The picloram label does not require the use of protective cloth-
ing or a closed loading system. Dermal exposures for mixer/loaders
are calculated from surrogate data available.
Data for the assessment for exposure to HCB from forestry
uses of picloram were taken directly from U.S. Department of
Agriculture Forest Service data on phenoxy herbicides (2,4-D
and 2,4,5-T). Estimates of potential exposure to picloram are
based on aerial and ground application. The maximum aerial
application rate for picloram is 1.9 Ib ae/A, while the compound
is applied from the ground at rates as high as 10 Ib ae/A. Risk
was calculated by calculating a lifetime average daily dose (LADD)
which then multiplied by the Q]_*.
Exposure data for the use on rights-of way are not available;
however, exposure rates for aerial application are expected to
be lower than those estimated for pasture/rangeland use, and
exposure rates for ground application are expected to be lower
than those estimated for forest use.
The Agency considers the dietary risk and nondietary risk
from HCB to be acceptable provided that HCB levels in the tech-
nical product do not exceed the certified limits of 200 ppm.
Refer to Chart entitled "HCB - Risk Characteristics" for exposure
and risk calculations.
15
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HCB - Risk Characteristics
Exposure
Risk
Ground Boom
(wheat)
Private
Mixing/loading
Applying
Combined
Commercial
Mixing/loading
Applying
Combined
1.
mg/kg/yr
1.6 x 10-5
4.8 x 10-6
2.0 x 10-5
8.0 x 10~5
2.4 x 10-5
1.0 x 10~4
2.
mg/kg/day (lifetime)
1. x 1 x 35
365 70
2.2 x 10~8
6.0 x 10-9
2.8 x 10~8
1.1 x 1(T7
3.3 x 10-8
1.4 x 10-7
2. x Q* (mg/kg/day)-l
(2. x 1.7)
4 x 10-8
1 x 10-8
5 x 10-8
2 x 10-7
6 x 10-8
2 x 10~7
Aerial
(range/pasture)
[0.5 Ibs ae/acre)
Mixing/loading
Applying
Flagger
[40 Ibs ae/acre]
Mixing/loading
Applying
Flagger
Forestry
Mixing/loading
Obsever
Backpack sprayer
8.0 x 10~3
6.4 x 10-5
3.6 x ID'5
6.4 x 10-2
5.2 x 10-5
2.9 x 10~4
2.0 x 10-2
1.5 x 10~3
8.0 x 10-3
1.1 x ID"5
8.0 x 10~9
5.0 x 10~8
9.0 x 10-5
7.2 x 10-8
4.1 x
2.8 x ID"5
2.1 x 10~6
1.1 x 10-5
2 X 10-5
2 X ID"8
8 x 10-8
2 x 10-4
1 x 10-7
7 x 10-7
5 x
4 x
2 x
10-5
10~6
10~5
16
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2. Nitrosoamines
The 1985 standard established an upper limit of no greater
than 1 ppm for the presence of nitrosoamines in technical picloram.
Nitrosoamines are a potential contaminant of the tertiary amines
(TEA) and alkanolamine (TIPA) forms of picloram. Testing is
required for TEA and TIPA to show that a level of 1 ppm nitrosoamine
contamination is not exceeded. Refer to 45 FR 42854 for discussion.
Testing requirements are discussed in the data tables in Appendix
I.
D. PHYSIOLOGICAL AND BIOCHEMICAL BEHAVIOR CHARACTERISTICS
Picloram translocates from both the roots and leaves of
plants and accumulates in the new growth. Picloram is both
foliar-absorbed and root absorbed. When picloram is applied to
foliage it moves in the phloem and xylem tissues and when applied
to the soil picloram moves rapidly in the xylem.
The mode of action of picloram involves altering of nucleic
acid and protein synthesis by affecting a variety of enzymes.
Available plant metabolism data indicate that picloram
degrades to C02/ oxalic acid, and the metabolites 4-amino-2,3,5-
trichloropyridine and 4-amino-3,5-dichloro-6-hydroxypicolinic
acid.
Available metabolism data in poultry indicate that 99.9
percent of the recovered radioactivity is found in the excreta
and that 98 to 99 percent of the 14C residues are characterized
as picloram. Radioactivity in the kidney was also identified as
picloram (91 to 94%) and 82 to 88 percent of the radioactivity
in the liver was characterized as picloram. Available metabolism
data in lactating goats indicate that 90 to 96 percent of the
administered 14C activity recovered in the urine and feces was
identical to the [14C]picloram used in dosing the animals.
These data indicate that picloram is not metabolized by animals.
17
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E. ENVIRONMENTAL CHARACTERISTICS
In an acceptable hydrolysis study submitted in response to
the 1985 Standard, the ring-labeled isooctyl ester of picloram
degraded with half-lives of > 28 days (calculated 61.5 days) in
sterile aqueous buffered pH 5 solutions, approximately 28 days
(calculated 38.7 days) in pH 7 solutions, and 3.5 to 21.5 hours
(calculated 18.4 hours) in pH 9 solutions incubated in the dark
at 25 °C.
In an acceptable hydrolysis study reviewed under the 1985
Standard, labeled picloram in dilute phosphate buffers (pHs 5, 7,
and 9) snowed that greater than 90 percent of the picloram remained
after 70 days. The estimated half-life was greater than 1.8
years at 45 °C. This study was reevaluated for this Standard and
determined acceptable to fulfill Guideline requirements.
In an acceptable aerobic metabolism study submitted in response
to the 1985 Standard, the ring-labeled isooctyl ester degraded
with half-lives of < 2 days in clay loam soil, 2 to 4 days in
silt loam soil, and 4 to 7 days in sandy loam soil under aerobic
conditions. Picloram and C02 were the only degradates found.
Picloram was relatively stable in anaerobic loam soil incubated
in the dark and under anaerobic aquatic soil conditions.
In an acceptable aerobic metabolism study reviewed under the
1985 Standard, ring-labeled picloram degraded with half-lives of
100 to 200 days in Holdridge loam and uncharacterized soils; 200
to 300 days in silt loam soil, and > 300 days in loamy sand,
commerce loam, clay, and sandy loam soils under aerobic conditions.
The major degradate was CC^- This study was reevaluated for this
Standard and determined acceptable to fulfill Guideline requirements.
In an acceptable fish accumulation study reviewed under the
1985 Standard, picloram residues did not accumulate in bluegill
sunfish. This study was reevaluated for this Standard and deter-
mined acceptable to fulfill Guideline requirements.
Photodegradation studies in water considered partially accep-
table in the 1985 standard upon re-evaluation were considered
unacceptable by the 1984 Guidelines. In a photodegradation in
water study submitted in response to the 1985 Standard picloram
IDE degraded with a half-life of 1 hour (calculated 1.1 hours)
in sterile aqueous buffered pH 5 solutions that were irradiated
with phosphor-coated mercury lamps. This study does not fulfill
guideline requirements because the artifical light source was
not similar to sunlight.
18
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In a soil photodegradation study submitted in response to
the 1985 Standard, picloram did not degrade during 384 hours of
irradiation with a mercury arc lamp. Picloram comprised 90
percent of the applied radioactivity in the irradiated soil
and 96.7 percent of applied radioactivity in the dark control
384 hours posttreatment. This study does not fulfill guideline
requirements because the artifical light used was not similar
to sunlight.
In a leaching and absorption study considered acceptable in
the 1985 Standard, picloram was intermediately mobile to very
mobile in soils ranging in texture from clay to loam. Absorption
of picloram increased with increasing soil matter and decreasing
soil solution pH. Addition of inorganic salts to the soil did
not affect adsorption of picloram. In another leaching and
adsorption/desorption study considered in the 1985 Standard, 27
percent of the applied carboxyl-labeled [-^C]picloram was
adsorbed by loam soil during 14 days of equilibrium at 25 °C with
a buffered pH 7 aqueous solutions (soil:solution ratio 1:4)
containing 0.25 ppm of picloram. Seventy-one percent of the
applied [^-^C] picloram was absorbed by loam soil after 23 days
of shaking at 25 °C in buffered pH 7 aqueous solutions (soil:
solution ratio 1:4) containing 0.25 ppm of picloram. The review
of these studies was completed before finalization of the 1984
Guidelines (49 FR 42856). Under these guidelines these studies
are classified as supplementary data.
A field dissipation study submitted in response to the 1985
Standard evaluating dissipation and leaching of picloram provided
the information that follows.
Picloram dissipated with an estimated half-life of 34 days
in a field plot of sand and sandy loam soil. In the 0- to 6-inch
soil depth, picloram declined from a maximum of 0.2 ppm 5 days
posttreatment to _< 0.01 ppm by day 174. In the 6- to 12-inch
depth, picloram reached a maximum of 0.03 ppm by day 21 and
declined to < 0.005 ppm by day 100. In the 12- to 24-inch depth,
picloram was < 0.005 ppm at all sampling intervals. In the 24-
to 36- and 36- to 48-inch depths, picloram was a maximum of 0.02
ppm at day 14 (first time the 24 to 36-inch depth was sampled)
and declined to £ 0.005 ppm by day 21. This study does not
fulfill guideline requirements because no freezer storage stabi-
lity data were provided and the soil may not have been sampled
to an adequate depth to define the extent of leaching.
No picloram was detected in any of the water samples taken
from two wells inside and downhill from the field plot (slope
0-4%, distance to water table 22.3 feet).
-------
In a forestry dissipation study submitted in response to the
1985 Standard picloram degraded with a half-life of < 28 days in
the upper 7 cm of forest soils (uncharacterized) in North Carolina
that had been treated with the K salt of picloram (Tordon 10K,
10% ae P/T formulation) at 5 kg ai/ha. Picloram declined from
11.58 ppm at 16 days posttreatment (first sampling: 1 day follow-
ing the first rainfall) to 2.21 ppm at 28 days and 0.06 ppm at
215 days. In samples taken from deeper soil, initial concentra-
tions of picloram were 3.8 ppm in the 15 cm depth (16 days),
1.63 ppm in the 30 cm depth (16 days), 0.98 ppm in the 22 cm
depth (28 days) 0.45 ppm in the 60 cm depth (70 days), and 0.13
ppm in the 120 cm depths (70 days). At 215 days posttreatment,
picloram was £ 0.04 ppm at the 15 through 120 cm depths. In
soil solutions obtained using lysimeters, picloram was £ 174 ppb
at the 30 cm depth (maximum 3 months posttreatment), _< 179 ppb
at the 60 cm depth (maximum 5 months), and £ 2 ppb at the 120 cm
depth. Picloram was detected in water from downslope springs 18
times during 10 months of sampling and never at > 1.0 ppb; piclo-
ram was first detected at 7 months posttreatment. Picloram was
_< 3 ppb in the upper stream sampling site (maximum 1 month post-
treat ment); picloram was detected twice at the lower stream
site, once at 2 ppb and once at 8 ppb (2 months posttreatment).
This study do not fulfill guidelines because pretreatment and/or
immediate posttreatment data were not reported for soil and water;
the soils were incompletely characterized; the soils were not
sampled deep enough to determine the extent of the leaching; and
no foliage, leaf litter, standing water, or sediment samples were
taken.
The 1985 standard required aerobic aquatic testing for
aquatic nonfood uses. The registrant requested a waiver based
on the position that there were no registered aquatic nonfood
uses. The use on outer ditch banks is an aquatic use and must
be supported by the required data.
Picloram (free acid) is formulated into two chemical forms:
three salt forms (triisopropanolamine, potassium, and triethylamine)
and one ester form (isooctyl). For the purpose of conducting
environmental studies, a free acid/salt form and isooctyl ester
form of picloram are the required test substances for most of the
studies. The exception to this is the required terrestrial field
dissipation studies which require all three registered formulations
of picloram. Refer to data tables in Appendix I for testing
requirements.
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F. GROUNDWATER CONTAMINATION
Picloram has been previously identified as a pesticide with a
propensity to leach into groundwater. Picloram was classified as
a "Restricted Use" pesticide by regulations proposed in 1977 (42
FR 44171) and finalized in 1978 (43 FR 5792) partially on recurring
reports of phytotoxicity to such economically important crops as
tomatoes, potatoes, tobacco, legumes, and succulent ornamentals
caused by contaminated water supplies (1 ppb range) from runoff
and leaching. The 1985 Standard retained the "Restricted Use"
classification and required that a groundwater advisory statement
be included on the label. Additional dissipation data and a
retrospective groundwater monitoring study were required by the
1985 Standard.
Picloram has been reported as detected in seven states,
Kansas, Missouri, Minnesota, North Dakota, New York, South Dakota,
and Wisconsin. All of these detections have been attributed to
normal field use of picloram.
The data discussed above, in the Environmental Section,
indicate that picloram is persistent and mobile and has a high
potential to reach groundwater. This is corroborated by reports
from several States of detection of picloram in groundwater.
Because available data indicate that picloram has a high
potential to contaminate groundwater and available pesticide
incident reports indicate loss of economically important crop
from irrigation by water contaminanted with low levels of piclo-
ram the Agency will retain the "Restricted Use" due to ground-
water contamination.
Since completion of the 1985 Standard, the Agency has approved
a request to convert the required retrospective monitoring study
to a prospective groundwater monitoring study. This study is due
in July 1989. Further data may be required if it is determined
that a more widespread characterization of the groundwater
contamination hazard is needed.
21
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The Agency has also approved a request to revise the ground-
water statement required by the 1985 Standard. The Agency will
retain the approved groundwater advisory statement.
G. EXPOSURE AND REENTRY
Based on available acute toxicology data, the major routes of
concern appear to be through inhalation exposure. Although
technical picloram (free acid) is placed in Toxicity Category I
because of inhalation, there is little chance of exposure to
mixer/loaders or applicators because there are currently no
products registered containing the free acid (technical) form of
picloram.
Reentry data or intervals are not required for picloram
because cultural practices for existing uses (pasture/rangeland,
rights-of-way, forestry, and small grains) indicate little likeli-
hood that field workers would be exposed to acutely toxic levels
of picloram following agricultural applications.
H. ECOLOGICAL CHARACTERISTICS
Terrestrial Organisms
Based on acute oral toxicities > 2250 mg/kg/day (technical)
and > 2510 mg/kg/day (K salt) to mallard ducks, picloram technical
and K salt are practically nontoxic to avian species on an acute
basis. Available data indicate that 8-day dietary toxicity of
picloram technical is > 5000 ppm for mallard ducks and bobwhite
quail, that the 8-day dietary toxicity for the picloram K salt is
> 5620 ppm for bobwhite quail, and that the 8-day dietary toxicity
for the IOE of picloram is > 5620 ppm for bobwhite quail. Based
on these data, technical picloram, its K salt, and its IOE form
are practically nontoxic to avian species on a chronic basis.
The requirements for acute oral toxicity and dietary toxicity
tests with avian species have been satisfied. Additional testing
will not be required on picloram derivatives (potassium salt,
isooctyl ester) because of similarity in toxicity values that
were noted in available data.
22
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Technical picloram is relatively nontoxic to honey bees.
Available data indicate that the 48-hour contact toxicity to honey
bees is 14.5 micrograms per bee. This requirement is fulfilled
for technical picloram. Honey bee acute testing is required for
all salts, esters, and amine forms of picloram.
Aquatic Organisms
Based on acute toxicities ranging from 4.3 to 19.3 ppm (trout)
and 14.5 to 23.0 ppm (bluegill), technical picloram appears to be
moderately to slightly toxic to coldwater fish and slightly toxic
to warmwater fish. Based on acute toxicities of 13 ppm (rainbow
trout), 14 ppm (catfish), and 24 ppm (bluegill) the K salt of
picloram is slightly toxic to freshwater fish. The isooctyl ester
of picloram is moderately toxic to fish with acute toxicities of
1.4 ppm (catfish), 4.0 ppm (rainbow trout), and 6.3 ppm (catfish).
The requirements for acute fish toxicity testing have been ful-
filled. Additional acute testing of picloram salts, esters, and
amines are not required because of the similarity in toxic values
noted in available data.
In a fish-embryo larvae test, picloram caused a reduction in
larval survival at 2.02 ppm and a reduction in growth at 0.88 ppm.
In a chronic study designed to simulate picloram (acid) runoff
following successive rainfalls, data suggest that picloram may
affect survival and growth of cutthroat trout alevins at a
concentration of 0.29 ppm. The requirement for fish early life
stage testing with picloram technical acid has been fulfilled.
Picloram appears to be slightly toxic to aquatic invertebrates
(daphnids, gammarus, Pteronarcella, and Pteronarcys) with an acute
range of 10 to 68.3 ppm. Chronic testing showed that picloram toxi-
city caused a reduction in daphnid brood size and the number of
young at 18.1 ppm. This chronic level suggests that picloram
is only slightly toxic to daphnids. The requirements for acute
and chronic invertebrate testing have been fulfilled. Additional
acute or chronic invertebrate testing are not required for the
salts, esters, or amines of picloram because of the similarity
in toxic values noted in available data.
A field monitoring study to determine concentrations of
picloram in runoff water and sediment, leachate, groundwater,
and in water and sediment of receiving aquifers was required
by the 1985 Standard. Subsequently the Agency determined that
this study would not be required.
23
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Picloram is water soluble and there is a potential for aquatic
exposure through runoff and leaching. in assessing the hazard to
aquatic life, the Agency calculated the Estimated Environmental
Concentrations (EEC) of picloram in the water. Using the standard
Agency pond model of 10 acres of runoff feeding into a 1-acre
pond 6 ft deep, maximum residues were calculated for the major
applications of picloram (rangeland, rights-of-way, and forestry).
The expected picloram residues for pastures/rangeland and rights-
of-way are below the acute toxicity values for fish and invertebrates
by one to two orders of magnitude (acute toxicities of 0.5 to
0.68 ppm and EEC of 0.02 to 0.12 ppm). Based on this information,
picloram does not appear to be an acute hazard to fish. However,
picloram ground application for forestry could produce residues
of 0.26 ppm which are comparable to chronic toxicity effects to
the cutthroat trout larvae (growth and survival effected at about
0.29 ppm). Because the expected runoff from picloram (0.26 ppm)
is less than the effect level (0.29 ppm) to larvae and the model
used is considered a "worst case" only minimal concern exists at
this time. This affect will be re-evaluated once required environ-
mental fate data are submitted.
Plant Protection
In the 1985 Standard, Tier I nontarget area phytotoxicity
data were required. Most of the studies submitted in response
to the 1985 Standard were not acceptable to fulfill the require-
ments. However, available data indicate that picloram with a
phytotoxicity of 36.41 mg/L (cells/mL) is not expected to exert
a detrimental effect on the algae Selenastrum capricornutum when
applied at current maximum rates. Additional Tier I testing will
not be required since Tier II testing is required.
Because picloram is a herbicide, Tier II phytotoxicity testing
(see Data Tables) is required to establish toxicity to nontarget
plants. These tests are required for the technical picloram, its
salts, amines, and esters because no comparative studies are
available.
Phytotoxicity
In 1978, the Agency classified picloram as a Restricted Use
pesticide through regulations proposed in the September 1, 1977
(42 PR 44170) and finalized in the February 9, 1978 (43 FR 5782)
issues of the FEDERAL REGISTER. The criteria influencing the
restriction was hazard to nontarget organisms (specifically
nontarget plants both crop and noncrop) and recurring reports of
phytotoxicity to such economically important crops as tomatoes,
potatoes, tobacco, legumes, and succulent ornamentals caused by
contaminated water supplies (1 ppb range) from runoff and leaching.
24
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In the 1985 Standard, the Agency retained the "Restricted
Use" classification based on phytotoxicity.
Because of recurring reports of loss of ecomonically
important crops due to phytotoxicity from drift or contamination
of irrigation water the Agency will retain the "Restricted Use"
classification. The groundwater advisory will aid in reduction
of risk to nontarget plants by advising against the use of picloram
in areas where picloram is most likely to move through the soil
into groundwater.
In the 1985 Standard spray drift droplet size and drift field
studies were required. Data submitted in response to this require-
ment were not acceptable because experimental design was not accord-
ing to current guideline requirements. The Agency is requiring
that spray drift droplet size and drift field studies be submitted
for picloram. These studies are required because of the following
picloram concerns: phytotoxicity, aerial application, and likely
exposure to nontarget plants. The droplet spectrum study is
performed to reflect the nozzle and other equipment types to be
used in application of picloram to pasture/rangeland, rights-of-
way and forestry uses. The spray drift field evaluation is being
performed to reflect the application equipment, use patterns, and
typical locations of use, which includes different weather factors
in applications of picloram for these uses.
Endangered Species
Because of the demonstrated toxicity to nontarget plant
species and the intended use pattern, picloram has been identi-
fied by the U.S. Fish and Wildlife Service as being likely to
jeopardize endangered plant species when used on pastures/range-
land and forests. Based on this determination the U.S. Fish
and Wildlife Service specified reasonable and prudent alternatives
to avoid jeopardizing the continued existence of the species by
these uses. EPA is working with the Fish and Wildlife Service
and other Federal and State Agencies to implement the alternatives
in a technically sound manner.
Because of picloram low toxicity to avian species, aquatic
species, and mammals, endangered animal species are not expected
to be jeopardized by the use of picloram. Some aquatic inverte-
brates may be jeopardized.
25
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I. PRODUCT CHEMISTRY
The Agency has determined that product chemistry data for all
technicals and MPs must be submitted for each pesticide because
new requirements have been introduced and previously submitted
data must be updated. Therefore, most of the product chemistry
data for the technical deemed acceptable in the 1985 Standard
must be updated and submitted. Much of the data submitted recently
are acceptable for the K salts. Refer to the data tables for
detailed requirements.
No data are available for the IOE, TIPA, TEA, or IPA forms of
picloram. These data are required. Refer to the data tables for
detailed requirements.
J. PESTICIDE INCIDENT REPORTS
The Agency has received a number of pesticide incident reports
with respect to crop and other nontarget plant damage. The
damage was attributed to one or more of these factors: soil
residues, drift from aerial or ground application, runoff after
heavy rains, movement in irrigation water, or movement in ground-
water.
K. TOLERANCE ASSESSMENT
Tolerances have been established for residues of picloram
from application of its acid form, it potassium salt form, its
triethylamine or triisopropanalamine salt under 40 CFR 180.292.
Food and feed additive tolerance have been established for piclo-
ram under 40 CFR 185.4850 and 186.4850. These sections replace
the earlier 21 CFR 193.350 and 21 CFR 561.305 sections.
A Canadian tolerance has been established for barley at 1.0
ppm. This is not consistent with tolerances established. No
other Canadian, Mexican, or Codex tolerances have been established
for picloram.
Residue Data
The residue data reviewed in support of these tolerances, and
the data gaps are discussed below.
1. In the 1985 Standard the nature of residue in plants was
deemed to be adequately understood. Based on additional wheat
metabolism data submitted in support of a request to increase
tolerances in forage grasses the Agency has concluded that the
nature of the residue of picloram in plants is not adequately
understood. The available data fail to show the extent to which
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residues of picloram and its metabolites are conjugated in plant
tissues, and the portion of the residue accounted for by the
metabolites remains to be quantified.
2. In the 1985 Standard additional data was required to
define the nature of the residue in poultry. Based on a hen
metabolism study submitted in response to that request the nature
of the residue in poultry is adequately understood. Data depicting
the metabolism of picloram in hens indicate that 99.9 percent of
the recovered radioactivity was found in the excreta, and 98 to
99 percent of these 14c residues were characterized by HPLC as
picloram. GC-MS analysis of the radioactive fractions of the
excreta extract confirmed the identity of the residue as picloram.
The radioactivity in the kidney was also identified as picloram
(91-94%); an unidentified peak contained up to 6 percent of the
14C-activity in the kidney. In the liver extract, 82 to 88
percent of the radioactivity was characterized as picloram; an
unidentified compound accounted for 7 to 9 percent. Of the
radioactivity recovered in egg white, picloram accounted for 81
to 78 percent and several minor peaks each accounted for 2 to 5
percent of the l*c residues. These data were found to satisfy
the requirements for metabolism of picloram in poultry requested
in the 1985 Standard.
3. In the 1985 Standard additional data were required to
define the nature of the residue in ruminants. Data'submitted
in response to that Standard were not adequate to define the nature
of residue in ruminants, because complete characterizations of
14c-residues in milk and ruminant tissues have not been reported.
Data are required for the impurity, HCB. A determination of
whether this impurity must be included in the tolerance expressions
will await submission and review of data. Data for HCB were not
required in the 1985 standard.
4. Picloram has not been analyzed by any of the multiresidue
methods published in PAM Vol. I, Appendix II - Multiresidue Method
Testing; these data must be submitted. Analytical methodology
for the quantification of residues of the impurity HCB in or on
raw agricultural commodities (RACs) and processed products are also
needed. The methodology submitted for HCB must be capable of
detecting this chemical at levels of £ 1 ppb. Multiresidue method
testing is a new requirement since issuance of the 1985 Standard.
5. In the 1985 Standard storage stability data were required
for grain crops of wheat, barley, oats, flax and forage grasses.
Data submitted in response to that standard indicate residues of
picloram are stable in grasses, wheat and barley grains, straw
and green forages. Storage stability data on other crops were
not submitted in time for inclusion in this standard. Residue
data submitted for HCB must be supported by storage stability
data.
27
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6. Additional residue data for picloram in wheat grain
forage and straw are required. A processing study in wheat
grain is needed in order to determine whether residues of picloram
concentrate in wheat. The residue data should adequately represent
the full geographic range of states in which the use is registered.
These data must be accompanied by storage stability data. A pre-
harvest interval (PHI) must be proposed for wheat and submitted
data must support this interval. An appropriate tolerance must
be proposed for wheat hay based on supporting residue data. The
requirements for a PHI or hay tolerances were not required by
the 1985 standard. Tolerances for oat and barley hay must be
proposed.
7. Data for residues of HCB in wheat grain, forage and straw
are required. This data should be reported along with analysis
of each formulation for HCB. If detectable, weathered residues
of HCB are observed on wheat grain a processing study will be
required to determine whether HCB residues concentrate in milling
fractions of wheat. Residue data for HCB was not required by
the 1985 standard.
8. The data reviewed by the 1985 Standard indicated that the
established tolerance of 80 ppm on forage grasses was not adequate.
Data submitted in a petition to increase the tolerance for forage
grasses to 225 ppm were not adequate because data did not adequately
represent the full geographical ranges of states where this use
pattern is registered. Additional residue data for picloram are
required. A tolerance for grass hay must be proposed and supported
by data. All product labels with the pasture and rangeland use
must be modified to include a maximum number of applications per
season or a maximum seasonal rate. Required residue data must
reflect the maximum rate or maximum number of applications. The
1985 standard did not require a hay tolerance or label revision.
9. Data for residues of HCB in pasture and rangeland grasses
and their hays are required. This data should be reported with
analyses of each formulation for HCB. The 1985 standard did not
require HCB testing.
10. Additional residue data are required for flax depicting
levels of HCB in flaxseed or flax straw. HCB testing was not
required by the 1985 Standard.
11. The established tolerances for raw agricultural commodities,
animal commodities, food and feed items will be evaluated upon
receipt of requested data.
Dietary Exposure
The Agency has established a provisional acceptable daily
intake (PADI, R.F.D.) at 0.07 mg/kg/day based on a 6-month dog
feeding study (NOEL of 7.0 mg/kg/day} using a safety factor of
100. The theoretical maximum residue contribution (TMRC) is
calculated to be 0.001840 mg/kg/day, which utilizes 2.6 percent
of the PADI.
28
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IV. REGULATORY POSITIONS AND RATIONALE
A. REGULATORY POSITIONS AND RATIONALE
1. None of the risk criteria in 40 CFR 154.7 have been
exceeded for picloram. Therefore, no referral to Special Review
is being made at this time.
Rationale; A review of the available information indicates
that none of the risk criteria for adverse effects in 40 CFR 154.7
have been exceeded. Available data indicate that picloram does
not pose a risk of serious injury to humans, avian species, or
aquatic organisms. Refer to Agency assessment for discussion of
available data.
2. The Agency will continue to require that EPS containing
picloram retain the "Restricted Use" classification and the
groundwater advisory against the use of picloram on well-drained
soils. Refer to Required Labeling section for wording.
Rationale; Picloram has been found in groundwater (7
States have reported detections of picloram in groundwater;
Kansas, Missouri, North Dakota, New York, South Dakota, Wisconsin,
and Minnesota) and shown to be phytotoxic to nontarget plant
species. Available data indicate that picloram is intermediately
to very mobile in most soils and degrades very little under irra-
diation, anaerobic, or aerobic conditions indicating a potential
to contaminate groundwater. Refer to Agency Assessment for
discussion of data. The precaution advisory against the use of
picloram on well-drained soils will help reduce the risk of
phytotoxicity by advising against use of picloram in areas where
it is most likely to move through the soil into the groundwater.
Refer to History and Agency Assessment sections for detailed
discussion. Refer to Required Labeling section for appropriate
statements.
3. The Agency is requiring the rat and mouse oncogenicity
studies be repeated using Osborne-Mendel rats and BgC3Fi mice
of both sexes using a commercially available technical grade
picloram uncontaminated with HCB.
Rationale; A study using Osborne-Mendel rats showed an
oncogenic effect (neoplastic nodules) in the liver of females at
the highest dose. The test material for the rat study was a
technical grade picloram contaminated with a high level of HCB,
contaminant know to product liver tumors in some strains of rats
making it difficult to determine if the oncogenic effect is from
the HCB or the picloram. The mouse study showed no oncogenic
effects but was questionable as to whether an MTD was reached.
EPA classified picloram as Group D oncogen (not classified as to
human carcinogenicity).
29
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Because of deficiencies in the oncogenicity studies they should
be repeated using the same strains of test animals and technical
picloram uncontaminated by potentially tumorigenic levels of HCB.
4. The Agency has determined that acute, subchronic feeding,
teratology and mutagenicity studies are needed for the organic
esters and amines of picloram in addition to the complete toxico-
logical testing of the acid and/or K salt.
Rationale; In the 1985 Standard, the Agency considered
the different forms of picloram to be toxicologically similar and
required testing on the acid form to fulfill data requirements for
all forms of picloram. For consistency in evaluation of chemicals
with several forms, the Agency now considers salts, organic esters,
and amines to be significantly different and to behave differently
under testing unless data are available to show otherwise. The
Agency expects the acid and K salt to behave similarly. Because
the ester and the amines have a chemical moiety not present in
the acid or K salt, the remaining organic esters and amines are
significantly different, they may have different qualitative/
quantitative toxicological properties. To evaluate applicator
risk and to determine if these organic esters and amines differ
significantly from the acid and each other, basic toxicology
testing is required. Refer to data tables and Agency assessment
for specific requirements.
5. The Agency will continue to require manufacturers to
limit the level of HCB in the technical to a maximum of 200 ppm.
Rationale; Technical picloram is contaminated with HCB
which has been shown to be a carcinogen in several species of
rodent. A risk assessment performed by the Agency indicated that
risk estimates based on this level are acceptable. Refer to
Agency assessment for additional discussion.
6. The Agency is requiring nitrosamine testing for the
tertiary amine and alkanoloamine forms of picloram. The level of
nitrosamines permitted in these forms is a maximum of 1 ppm.
This position differs from the 1985 standard which limited the
nitrosamine level to 1 ppm in the technical only.
Rationale; Nitrosamines may be a potential contaminant
of the various amines used to produce the amine salts of picloram.
This chemical is regulated under a rule which requires testing
to show that a level of 1 ppm of nitrosamine contamination is
not exceeded. Refer to 45 FR 42854 for discussion. Testing
requirements are discussed in the product chemistry data tables.
30
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7. The Agency is requiring that a prospective groundwater
monitoring study be submitted for picloram.
Rationale; Picloram has been identified as a chemical
with potential to contaminate groundwater. This study is needed
to fully assess picloram1s groundwater contamination hazard. A
retrospective study was required by the 1985 Standard. The Agency
approved a request to convert the retrospective study to a pro-
spective study.
8. The Agency is requiring that Tier II phytotoxicity
testing be performed with technical picloram, K salt, and the
IOE, TIPA, TEA, and IPA forms of picloram.
Rationale; Picloram is a herbicide and has been shown
to be phytotoxic to nontarget plants. Tier I phytotoxicity
testing was required under the 1985 Standard. The data submitted
did not satisfy the requirements. Additional Tier I phytotoxicy
is not required because the Agency is requiring Tier II testing
to fully assess picloram1s phytoxicity. Data are required on
all forms of picloram because no comparative studies are available.
9. The Agency is requiring that droplet size spectrum and
drift field evaluation data be submitted for picloram. These
studies were required by the 1985 Standard.
Rationale; The data submitted in response to the 1985
standard was not acceptable because experimental design was not
in accordance with the 1985 Guidelines. These data are required
because of the chemical's phytotoxicity, its method of application
(aerial), and the exposure of off-site wildlife and plants to
picloram. The droplet spectrum study is to be performed to reflect
the nozzle and other equipment types to be used in the application
of picloram to pasture/rangeland, rights of way and forestry uses,
the spray drift evaluation is to be performed to reflect the appli-
cation equipment, use pattern, and typical locations of use which
includes different weather factors, in the application of picloram
for these uses.
10. The Agency is requiring that end-use product labels con-
tain language relevant to spray drift control. This position
remains unchanged from the 1985 standard. Refer to labeling
section for statements.
Rationale; The Agency has received a number of pesticide
incident reports with respect to loss of economically important
crops and other nontarget plant damage.
3.1
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11. The Agency is requiring that additional residue data
be submitted for wheat grain, forage, straw and processed frac-
tions of wheat. This data must adequately represent the full
geographical range of usage and must include data depicting
residue levels of and analyses of HCB. These data must be
analyzed by current or proposed enforcement methods capable
of detecting HCB levels <. 1 ppb. A PHI must be proposed and
supported by data. All residue data must be supported by
storage stability data. No data are required for barley or
oats.
Rationale; The residue data required by the 1985 Standard
were primarily storage stability data. These data were received
and acceptable. Residue data required in 1985 did not include
geographical representation or HCB testing. These data are now
required to access the adequacy of established tolerances.
Additional data are not required for oats and barley since data
submitted for wheat will support tolerances for wheat and barley.
12. The Agency is requiring that additional residue data be
submitted for forage grasses and hay. These data must represent
the geographical range of usage and report levels of HCB along
with analysis for HCB. Labels must be amended to reflect the
maximum application per season or maximum application rate per
season. The required residue data must reflect the maximum rate
or maximum number of applications per season.
Rationale; Data reviewed for 1985 Standard indicated
that the established tolerance for forage grasses was not adequate.
Data submitted to support an increase in tolerance did not ade-
quately represent the geographical range of this use pattern.
Residue data required in 1985 did not include data to represent
the geographical range or require HCB testing. These data are
now required to support the proposed tolerances.
13. The Agency is requiring that additional residue data
be submitted for flax and flaxseed.
Rationale; Residue data required by the 1985 Standard
did not include residue testing for HCB. These data are required
to fully assess the established tolerances for flax.
14. The Agency is requiring that additional residue data
be submitted for grass hay and wheat hay and that appropriate
tolerances be proposed for wheat, oat, barley, and grass hay.
Rationale; No residue data are available for hay and
no tolerances have been established.
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15. The Agency is requiring that additional plant metabolism
data be submitted providing complete identification and quantita-
tion of all terminal residues.
Rationale; In the 1985 Standard the nature of the residue
in plant was adequately defined. Additional metabolism data sub-
mitted in support of the request to increase tolerances for forage
grasses failed to show the extent to which residue of picloram and
its metabolites conjugate in plant tissues, and the portion of the
residue accounted for by the metabolites remains to be quantified.
No data are available for residues of HCB should be included in
the tolerance expression.
16. The Agency is requiring that further metabolism data be
submitted to define the nature of the residue in animals. These
data are required on ruminants. These data must include testing
for HCB. No additional poultry metabolism testing is required.
Rationale; Data submitted in response to the 1985
Standard adequately define the nature of residue in poultry so
no further poultry data are required. Refer to Residue Chemistry
Section of Tolerance Assessement for discussion. Data submitted
in response to the 1985 Standard for ruminants did not adequately
define the nature of the residue in ruminants because complete
characterizations of 14C residues in milk and ruminant tissues
were not reported and HCB was not tested for. HCB testing was
not required by the 1985 Standard.
17. The Agency is not requiring reentry data or intervals
at this time. Reentry intervals or data were not required by
the 1985 standard.
Rationale; Reentry data or intervals are not required
for picloram because cultural practices for existing uses indicate
little likelihood that field workers would be exposed to acutely
toxic levels of picloram after agricultural treatment. Although
the technical (free acid) form of picloram is placed in Toxicity
Category I based on inhalation, reentry intervals are not needed
because there are no products currently registered containing the
free acid form of picloram.
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18. The U.S. Fish and Wildlife Service has determined that
certain uses of picloram may jeopardize the continued existence
of endangered species or critical habitat of certain endangered
species. EPA is developing a program to reduce or eliminate ex-
posure to these species to a point where use does not result in
jeopardy, and will issue notice of any necessary labeling revi-
sions when the program is developed.
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 endan-
gered 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.
EPA is working to correct these errors prior to requiring
labeling to protect endangered species. When that program
is fully developed, notice of any labelng necessary to protect
endangered species will be issued.
19. The Agency is requiring that labeling for all end-use
and manufacturing use products determined to be skin sensitizers
by the results of acute toxicology data include the labeling
statement "This product may cause allergic skin reaction after
multiple exposures."
Rationale; Acute toxicology data reviewed (refer to
Agency Assessment) indicate that some forms of picloram are
skin sensitizers and require that the statement "This product
may cause allergic skin reaction after multiple exposures."
appear on the label.
20. The Agency will not approve any significant* new food
uses for picloram until required residue chemistry and toxicology
data are available to assess existing and new uses.
Rationale; It is Agency policy not to establish signifi-
cant new uses where major toxicology and residue chemistry data
gaps exist. When additional data are evaluated the Agency will
determine whether significant new uses may be established.
*"Significant new uses" is defined in 44 PR 27934, May 11, 1979.
In the case of a new food or feed use, the Agency will consider
as significant an increase in the TMRC of > 1 percent.
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21. The Agency has identified certain data that will receive
immediate review when submitted.
Rationale; Certain data are essential to the Agency's
assessment of this pesticide and its uses and/or may trigger the
need for further studies.
Part 158 Subpart C - Product Chemistry - Concerns about
hazards presented by impurities (HCB and nitrosamines).
61-2 - Description of Beginning Materials and
Manufacturing Process
61-3 - Discussion of Formation of Impurities
62-1 - Preliminary Analysis
62-2 -. Certification of Limits
62-3 - Analytical Methods to Verify Certified
Limit
158.340 - Residue Chemistry - To determine which
metabolites (plant or animal) must be tested for in the field
trials and processing studies.
171-4 - Plant Metabolism
171-4 - Animal Metabolism
171-4 - Residue Analytical Methods
Part 158.315 - Toxicology - To fully determine
toxicological potential of picloram.
81-1
thru
81-6 - Acute Toxicity on esters and
amines of picloram.
82-1 - 90-Day Feeding (rodent and nonrodent) on
esters and amines of picloram - Needed
to determine if chronic testing is
required.
82-2 - 21-Day Dermal - Needed to determine if
additional testing is required.
83-2 - Oncogenicity (rat and mouse)
83-3 - Teratology, both species
83-4 - Reproduction
84-2 - Mutagenicity
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158.290 - Environmental Fate - To fully define potential
of picloram to contaminate groundwater.
158-75 - Groundwater Monitoring Data
158.440 - Spray Drift - To determine potential phytotoxicity
to nontarget plants from drift.
22. While data gaps are being filled, currently registered
MPs and EPs containing picloram may be sold, distributed, formulated,
and used, subject to the terms and conditions specified in this
Standard. Additionally, registrants must provide or agree to
develop additional data, as specified in the Data Appendices, in
order to maintain existing registrations.
Rationale; Under FIFRA sections 3(c)(2)(B) and 3(c)(7)
the Agency may elect not to cancel or withhold registrations if
data are missing or inadequate. Issuance of this Standard pro-
vides 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.
B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard, products
must contain picloram bear required labeling, and conform to the
product composition, acute toxicity limits, and use pattern require-
ments listed in this section.
C. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
To be registered or reregistered under this Standard, manu-
facturing-use products (MPs) must contain this pesticide. Each
MP formulation proposed for registration must be fully described
with an appropriate certification of limits, stating maximum and
minimum amounts of the active ingredient and inert ingredients
which are present in products, as well as impurities found at
greater than 0.1 percent.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade,
and manufacturing-use products containing this pesticide provided
that the product labeling bears appropriate precautionary state-
ments for actue toxicity category in which each product is placed.
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3. Use Patterns
To be registered under this Standard, manufacturing-use
products must be labeled for formulation into end-use products
only for the commodities listed below. The EPA Index to Pesticide
Chemicals (for availability, see page 1) lists all registered uses,
as well as approved maximum application rates and frequencies.
- Terrestrial, non-domestic, food uses on:
small grains, flax, pastures and rangeland grasses
- Terrestrial, non-domestic, non-food uses on:
noncrop agricultural areas, uncultivated agricultural
areas, industrial sites, rights-of-way.
- Forestry Uses on:
forest lands site preparation and forest trees.
- Aquatic nonfood use on:
drainage ditchbanks
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 prodct containing this pesticide may be
released for shipment by the registrant after September 30,
1989, unless the product bears an amended label which complies
with the requirements of this Standard.
No pesticide product containing this pesticide may be
distributed or sold after September 30, 1990 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.
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INGREDIENT STATEMENT
The ingredient statement for products must list the
active ingredient as:
INGREDIENT STATEMENT
ACTIVE INGREDIENT:
Pi dor am (4-amino-3,5,6-trichloro-
picolinic acid) %
INERT INGREDIENTS: %
ACTIVE INGREDIENT:
Picloram (4-amino-3,5,6-trichloro-
picolinic acid), as the potassium
salt %
INERT INGREDIENTS: %
ACTIVE INGREDIENT:
Picloram (4-amino-3,5,6-trichloro-
picolinic acid), as the triethylamine
salt %
INERT INGREDIENTS: %
ACTIVE INGREDIENT:
Picloram (4-amino-3,5,6-trichloro-
picolinic acid), as the triisopropano-
lamine salt %
INERT INGREDIENTS: %
ACTIVE INGREDIENT:
Picloram (4-amino-3,5,6-trichloro-
picolinic acid), as the isooctyl
ester %
INERT INGREDIENTS: %
ACTIVE INGREDIENT:
Picloram (4-amino-3,5,6-trichloro-
picolinic acid), as the isopropanola-
mine %
INERT INGREDIENTS: %
38
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Manufacturing-Use Products
1. The following statements must appear directly beneath the
product name:
A Herbicide For Formulating Use Only.
Formulators using this product are
responsible for obtaining EPA regis-
tration of their formulated products.
For formulation into end-use herbicide
products intended only for the following
uses
Picloram, potassium salt; Terrestrial food
crop use on small grains, flax, pastures,
and rangeland grasses;
Terrestrial noncrop site on noncrop
agricultural areas and rights-of-way;
Forestry use on forest lands site
preparation.
Picloram, isooctyl ester; Terrestrial
nonfood crops use on industrial sites and
rights-of-way;
Forestry use on forest trees site
preparation.
Picloram, triisopropanolamine salt;
Terrestrial food crop use on small grains
and pastures and rangeland;
Terrestrial nonfood crop use on
uncultivated agricultural areas, rights-
of-way, and industrial sites;
Aquatic nonfood crop use on drainage
ditchbanks;
Forestry use on forest trees.
Picloram, triethylamine salt;
Terrestrial food crop use on pastures and
rangelands.
39
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2. The following environmental hazards statement labeling
is specified for all MPs.
Do not discharge effluent containing this
product into lakes, streams, ponds, estu-
aries, 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 noti-
fying the sewage treatment plant authority.
For guidance, contact your State Water
Board or Regional Office of the EPA.
3. All MPs that are dermal sensitizers based on acute
toxicology studies must include the following precautionary
statement on their labels:
This product may cause allergic skin reaction
after multiple exposures.
End-Use Labeling
1. Restricted Use Statement
The following Restricted Use statement must appear on the
front panel of all picloram EPs.
RESTRICTED USE PESTICIDE
Due to Groundwater Contamination.
Toxic to Nontarget Plants
For retail sale to and use only by certified
applicator or persons under their direct
supervision and only for those uses covered
by the certified applicator's certification.
Commercial certified applicators must also
ensure that all persons involved in these
activities are informed of the precautionary
statements.
40
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2. The following groundwater advisory statement must appear
on the label of an EP containing picloram.
Picloram is a chemical which can travel
(seep or leach) through soil and under
certain conditions contaminate groundwater
which may be used for irrigation and
drinking purposes. Users are advised not
to apply picloram where soils have a rapid
to very rapid permeability throughout the
profile (such as loamy sand to sand) and
the water table of an underlying aquifer
is shallow, or to soils containing
sinkholes over limestone bedrock, severely
fractured surfaces, and substrates which
would allow direct introduction into an
aquifer. Your local agricultural
agencies can provide further information
on the type of soil in your area and the
location of groundwater.
3. The following revised Environmental Hazards statement
must appear on the label of EPs containing picloram.
Do not apply directly to water or wetlands
(swamps, bogs, marshes, and potholes). Do
not contaminate water when disposing of
equipment washwaters.
4. All EPs that are dermal sensitizers based on acute
toxicology data must include the following precautionary
statements on their labels:
This product may cause allergic skin reaction
after multiple exposure.
5. All end-use products must include the following
statement pertaining to drift on their labels:
"Do not make application when circumstances favor
movement from treatment site."
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the o^sticides
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 B.2
3. The labeling requirements specified for
manufacturing use products in Section IV.
4. Administrative requirements (application forms,
Confidential Statement of Formula, data
compensation provisions) associated with
reregistration.
B. Manufacturing use products containing this pesticide as
one of multiple active ingredients are subject to:
1. The data requirements listed in Table A.
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. The Agency has decided that, in most cases, it
will not require the submittal of product-specific data for
end-use products at this time. Therefore, most Registration
Standards do not contain a Table C.
42
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2. The labeling requirements specified for
manufacturing use products in Section IV.
C. End use products containing this pesticide as the sole
active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to
the end use product.
2. If eligible for the generic data exemption,3 the
data requirements listed in Table C.
3. If not eligible for the generic data exemption, the
data requirements listed in Table A and the data
requirements listed in Table C.
4. The labeling requirements specified for end use
products in Section IV.
D. End use products containing this pesticide as one of
multiple active ingredients are subject to:
1. If not eligible for the generic data exemption, the
data requirements listed in Tables A and C.
2. If eligible for the generic data exemption, the
data requirements listed in Table C.
3. The labeling requirements specified for end use
products in Section IV.
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.
43
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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
registration of products containing this active ingredient.4
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often
required for ecological effects studies and applies to all
products having that formulation type. These are classed as
generic data, and are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in 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 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.
4Registrations granted after issuance of this Standard
will be conditioned upon submittal or citation of the data
listed in this Registration Standard.
44
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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:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
submit the data on which you will rely. You must also
provide EPA with documentary evidence that an agreement has
been formed which allows you to rely upon the data to be
submitted. Such evidence may be: (1) your letter offering to
join in an agreement and the other registrant's acceptance of
your offer, (2) a written statement by the parties that an
agreement exists, or (3) a written statement by the person
45
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who will be submitting the data that you may rely upon its
submittal. The Agency will also require adequate assurance
that the person whom you state will provide the data is
taking appropriate steps to secure it. The agreement to
produce the data need not specify all of the terms of the
final arrangement between the parties or a mechanism to
resolve the terms.
If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data
Submitter Number, as part of your 90-day response. The
request must include the following information:
a. A list of the members of the consortium;
b. The name and address of the designated
representative of the consortium, with whom EPA
will correspond concerning the data;
c. Identity of the Registration Standard containing
the data requirement;
d. A list of the products affected (from all members
of the consortium); and
e. Identification of the specific data that the
consortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submittals by the consortium.
3. You have attempted to enter into an agreement to
jointly develop data, but no other registrant has accepted
your offer. You request that EPA not suspend your
registration for non-compliance with the DCI. EPA has
determined that, as a general policy, it will not suspend the
registration of a product when the registrant has in good
faith sought and continues to seek to enter into a data
development/cost sharing program, but the other registrants
developing the data have refused to accept its offer. [If
your offer is accepted, you may qualify for Option 2 above by
entering into an agreement to supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification of Attempt
to Enter into an Agreement with other Registrants for
Develop-ment of Data" (EPA Form 8580-6, enclosed).
2. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of
your offer (such as a certified mail receipt). Your offer
must, at a minimum, contain the following language or its
equivalent:
[Your company name] offers to share in the burden of
producing the data required r>ursuant to FIFRA sec.
46
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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)
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 requirement applies, EPA does not anticipate
that many waivers will be granted. A request for waiver does
not extend the time-frames for developing required data, and
if your waiver request is denied, your registration may be
suspended if you fail to submit the data. The Agency will
respond in writing to your request for a waiver.
5. You request that EPA amend your registration by
deleting the uses for which the data are needed. You are not
required to submit data for uses which are no longer on your
label.
6. You request voluntary cancellation of the regis-
tration of your product (s) for which the data are needed.
E. Registrant Requests Regarding Data Requirements and
Agency Responses
All requests for modification of data requirements
(inapplicability, waiver), approval of protocols or protocol
47
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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
be modified as appropriate so that the data generated by the
study will satisfy the requirements of Part 158. Normally,
the Agency will not extend deadlines for complying with data
requirements when the studies were not conducted in accord
with acceptable standards. The OECD protocols are available
from OECD, 1750 Pennsylvania Avenue, N.W., Washington, D.C.
20006.
G. Procedures for requesting a change in test protocol.
If you will generate the required data and plan to use
test procedures which deviate from EPA's Pesticide Assessment
Guidelines or the Reports of Expert Groups to the Chemicals
Group, Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must submit for EPA
approval the protocols you propose to use.
You should submit your protocols before beginning
testing, because the Agency will not ordinarily accept as
sufficient studies using unapproved protocols. A request for
protocol approval will not extend the timeframe for submittal
of the data, nor will extensions generally be given to
48
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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.
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
49
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stocks and your estimate of the time required for their sale
or distribution; and
2. rDemonstration that such a provision would be
consistent with the provisions of FIFRA.
50
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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
requirements, 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
requirements for your products will result in suspension of
the product's registration.
51
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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 Registration Standard. Responses to
this Registration Standard must include draft labeling for
Agency review.
Labeling must be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for storage
in 8-1/2 x 11 files. Draft labeling must indicate the
intended colors of the final label, clear indication of the
front panel of the label, and the intended type sizes of the
text.
If you fail to submit revised labeling as required,
which complies with 40 CFR 156.10 and the specific
instructions in Section IV.D., EPA may seek to cancel the
registration of your product under FIFRA sec. 6.
52
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IX. INSTRUCTIONS FOR SUBMITTAL
All submittals in response to this Registration
Standard must be sent to the following address:
Office of Pesticide Programs
OPP Mailroom (TS-767C)
Environmental Protection Agency
401 M St. , SW
Washington, B.C. 20460
Attn: [Name of chemical] Registration Standard
All submittals in response to this Registration
Standard are non-fee items, including 90-day responses,
protocols and waiver requests, data, and revised labeling.
Submittals must be clearly identified as being in response to
the Registration Standard. Under no circumstances may
Registration Standard responses be combined with other types
of filings for which fees are required.
A. Manufacturing Use Products (MUPs) containing the subject
pesticide as sole active ingredient.
1. Within 90 days from receipt of this document, you
must submit for each product subject to this Registration
Standard:
a. Generic Data Exemption Statement (EPA Form 8580-3),
if applicable, or the "FIFRA Section 3(c)(2)(B)
Summary Sheet" (EPA Form 8580-1), with appropriate
attachments.
b. Confidential Statement of Formula (EPA Form
8570-4).
c. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40
CFR 152.80-152.99.
2. Within 9 months from receipt of this document you
must submit:
a. Application for Pesticide Registration (EPA Form
8570-1).
b. Two copies of any required product-specific data
(See Table B).
c. Three copies of draft labeling, including the
container label and any associated supplemental
labeling.
d. Product Specific Data Report (EPA Form 8580-4).
53
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3. Within the times set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is
delayed or aborted so that the schedule cannot be met,
immediately notify the Agency of the problem, the reasons for
the problem, and your proposed course of action.
B. Manufacturing Use Products containing the subject
pesticide in combination with other active ingredients.
1. Within 90 days from receipt of this document, you
must submit:
a. Generic Data Exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA sec. 3(c)(2)(B) Summary
Sheet, with appropriate attachments (EPA Form
8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
2. Within 9 months of receipt of this document, you
must submit:
Three copies of draft labeling, including the container
label and any associated supplemental labeling.
3. Within the time frames set forth in Table A, you
must submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is
delayed or aborted so that the schedule cannot be met,
immediately notify the Agency of the problem, the reasons for
the problem, and your proposed course of action.
C. End Use Products containing the subject pesticide as
sole active ingredient.
1. Within 90 days from receipt of this document, you
must submit:
a. Generic data exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA Section 3(c)(2)(B)
Summary Sheet, with appropriate attachments (EPA
Form 8580-1).
b. Confidential Statement of Formula (EPA Form
8570-4).
2. Within 9 months from receipt of this document you
must submit:
a. Two copies of any product-specific data, if
required by Table C.
f "
54
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b. Product Specific Data Report (EPA Form 8580-4) , if
Table C lists required product-specific data.
c. Three copies of draft labeling, including the
container label and any associated supplemental
labeling.
3. Within the times set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is
delayed or aborted so that the schedule cannot be met,
immediately notify the Agency of the problem, the reasons for
the problem, and your proposed course of action.
D. End Use Products containing the subject active
ingredient as one of multiple active ingredients
1. Within 90 days from receipt of this document, you
must submit:
a. Generic data exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA Section 3(c)(2)(B)
Summary Sheet, with appropriate attachments (EPA
Form 8580-1).
b. Confidential Statement of Formula (EPA Form
8570-4).
2. Within 9 months from the receipt of this document,
you must submit:
Three copies of draft labeling, including the container
label and any associated supplemental labeling.
3. Within the times set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is
delayed or aborted so that the schedule cannot be met,
immediately notify the Agency of the problem, the reasons for
the problem, and your proposed course of action.
E. Intrastate Products
Applications for full Federal registration of intrastate
products were required to be submitted no later than July 31,
1988. Unless an application, for registration was submitted
by that date, no product may be released for shipment by the
producer after July 31, 1988.
55
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I. DATA APPENDICES
56
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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 subst.ance.
r>
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
Table C contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 153.
The reference numbers accompanying each test refer to the
test protocols set out in the Pesticide Assessment Guidelines,
which are available from the National Technical Information
Service, 5285 Port Royal Road, Springfield, VA 22161.
2. Test Substance (Column 2). This column lists the composition
of the test substance required to be used for the test, as
follows:
TGAI = Technical grade of the active ingredient
PAI = Pure active ingredient
PAIRA = Pure active ingredient, radio laoeled
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 153. The following
letter designations are used for the given use patterns:
A = Terrestrial, food
B = Terrestrial, non-food
C = Aquatic, food
D = Aquatic, non-food
E = Greenhouse, food
F » Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I- = Indoor
Any other designations will be defined in a footnote to the table.
57
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TGUIDE-2
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that satisfy this data
requirement. These data may be cited by other registrants
in accordance with data compensation requirements of
Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such data
do not fully satisfy the data requirement. In some cases,
the Agency may possess data on one of two required species,
or may possess data on one test substance but not all.
The term may also indicate that the data available to
EPA are incomplete. In this case, when the data are
clarified, or additional details of the testing submitted
by the original data submitter, the data may be determined
to be acceptable. If this is the case, a footnote to
the table will usually say so.
NO - EPA either possesses no data which are sufficient
to fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional infor-
mation.
5. Bibliographic citation (Column 5). If the Agency has
acceptable data in its files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no
MRID number has been assigned. Refer to the Bibliography
Appendices for a complete citation of the study.
6. Must additional data be submitted? (Column 6). This
columnindicates whether the data must be submitted to the
Agency. If column 3 indicates that the Agency already has
data, this column will usually indicate NO. If column 3
indicates that the Agency has only partial data or no data,
this column will usually indicate YES. In some cases, even
though the Agency does not have the data, EPA will not require
its submission because of the unique characteristics of the
chemical; because data on another chemical can be used to
fulfill the data requirement; or because the data requirement
has been waived or reserved. Any such unusual situations
will be explained in a footnote to the table.
7. Timeframe for submission (Column 7). If column 5 requires
that data be submitted, this column indicates when the data
are to be submitted, based on the issuance date of the Regis-
tration Standard. The timeframes are those established either
as a result of a previous Data Call-in letter, or standardized
timeframes established by PR Notice 85-5 (August 22, 1985).
8. Footnotes (at the end of each table). Self-explanatory.
58
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Table A
Generic Data Requirements for Picloram
Ui
Data Requirement
§158.120
Product
61-1 -
61-2 -
61-3 -
Analysis
62-1 -
Product Chemistry
Identity
Product Identity
and Disclosure of
Ingredients
Description of
Beginning Materials
and Manufacturing
Process
Discussion of
Formation of
Impurities
and Certification of
Preliminary Analysis
Test Use
Snhshanrpl/ p^H-prn
Acid-TGAI All
K Salt
TIPA
IOE
TEA
IPA
Acid-TGAI All
K Salt
TIPA
IOE
TEA
IPA
Acid-TGAI All
K Salt
TIPA
IOE
TEA
IPA
Product Inqredients
Acid-TGAI All
K Salt
TIPA
IOE
TEA
IPA
Does EPA
Have Data?
No
No
NO
NO
NO
NO
Yes
No
NO
NO
NO
NO
Yes
Yes
No
NO
No
NO
Yes
Yes
NO
No
NO
NO
Timeframe
Bibliographic Must Additional for
Citation Data Be Submitted Submission
NR2/ NO
Yesl/
Yes!/
Yes!/
Yes!/
Yes!/
00115556 No
Yesl/
Yesl/
YesV
Yesl/
Yesl/
00154235 No
00154235 No
Yesi/
Yesl/
Yesi/
Yesl/
00154235 No
00154235 No
Yesl/
Yesl/
Yesl/
Yesl/
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
12 Months
12 Months
12 Months
12 Months
-------
Table A
Generic Data Requirements for Picloram (Cont'd)
Test use
Data Requirement Substanc*31/ Pattern
Does EPA
Have Data?
Timeframe
Bibliographic Must Additional for
Citation Data Be Submitted Submission
S158.120 Product Chemistry
Analysis and Certification of Product Ingredients (Cont'd)
62-2 -
62-3 -
ON
O
Physical
Certification of Acid-TGAI All
Limits K Salt
TIPA
IOE
TEA
IPA
Analytical Methods Acid-TGAI All
to Verify Certified
Limit K Salt
TIPA
IOE
TEA
IPA
and Chemical Characteristics
63-2 - Color Acid-TGAI All
K Salt
TIPA
IOE
TEA
IPA
fK>
NO
NO
NO
NO
NO
Yes
Yes
NO
Yes
NO
Yes
NO
Yes
NO
NO
NO
NO
NR2/
00154235
40588501
00154235
40588501
00154235
40588501
00154235
40588501
N/All/
40588501
No
Yesi/
Yes8_«9/
Yesi!/
Y
-------
Table A
Generic Data Requirements for Picloram (Cont'd)
Data Requirement
§158.120 Product Chemistry
Test Use
Substance1/ Pattern
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data Be Submitted
Timeframe
for
Submission
Physical and Chemical Characteristics (Cont'd)
63-3 - Physical State
63-4 - Odor
rs
.A
63-5 - Melting Point
63-6 - Boiling Point
Acid-TGAI All
K Salt
TIPA
IOE
TEA
IPA
Acid-TGAI All
K Salt
TIPA
IOE
TEA
IPA
Acid-TGAI All
K Salt
TIPA
IOE
TEA
IPA
Acid-TGAI All
K Salt
TIPA
IOE
TEA
IPA
No
Yes
No
No
No
No
No
Yes
No
No
NO
No
No
Yes
No
NO
No
No
No
Yes
No
No
No
No
N/A"/
40588501
N/A"/
40588501
N/A"/
40588501
N/A11/
40588501
Yes
No
No12/
ItoW
No][H/
Yes
No
NO12/
J}Q! 2/
{(Q! 2/
UQ! 2/
Yes
NoW
HcT^/
NoT2"/
No^"2*/
No12/
NOW
No
No12/
UQ! £/
^|Q! 2/
NoW
6 Months
6 Months
6 Months
-------
Table A
Generic Data Requirements for Picloram (Cont'd)
Test Use
Data Requirement Substance1/ Pattern
§158.120 Product Chemistry
Physical and Chemical Characteristics (Cont'd)
63-7 - Density, Bulk Acid-TGAI All
Density, or K Salt
Specific TIPA
Gravity IOE
TEA
IPA
63-8 - Solubility Acid-TGAI All
K Salt
TIPA
ON IOE
f\J TEA
IPA
63-9 - Vapor Pressure Acid-TGAI or PAI
K Salt
TIPA
IOE
TEA
IPA
63-10 - Dissociation Acid-TGAI or PAI
Constant K Salt
TIPA
IOE
TEA
IPA
Does EPA
Have Data?
No
Yes
No
No
No
No
No
No
No
No
No
No
No
NO
No
No
No
NO
No
No
NO
No
No
No
Time frame
Bibliographic Must Additional for
Citation Data Be Submitted Submission
N/A1 1 / Yes
40588501 No
No12/
Ho1"2/
jjo!2/
No]]*/
N/Aiy Yes
No1 ^/
Yes 1 5/
YesW
YeST57
Yes!*/
N/A^V Yes
No1 ^/
Yes1 •*/
Yeses'/
Yes1 5/
YesW
N/A1 1 / Yes
~ NoW
Yes 1 ->/
YesW
YesW
YesW
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
-------
Table A
Generic Data Requirements for Picloram (Cont'd)
Test Use
Data Requirement Substance1/ Pattern
§158.120
Physical
63-11 -
63-12 -
ON
63-13 -
63-14 -
Product Chemistry
and Chemical Characteristics (Cont'd)
Octanol/Water Acid-PAI All
Partition K Salt
Coefficient TIPA
IOE
TEA
IPA
pH Acid-PAI
K Salt
TIPA
IOE
TEA
IPA
Stability Acid-TGAI All
K Salt
TIPA
IOE
TEA
IPA
Oxidizing or Acid-TGAI All
Reducing K Salt
Action TIPA
IOE
TEA
IPA
Does EPA
Have Data?
No
No
No
No
No
No
No
Yes
No
No
NO
No
NO
NO
NO
No
No
No
NO
Yes
No
No
NO
No
Timef rame
Bibliographic Must Additional for
Citation Data Be Submitted Submission
N/A1 1 / Yes 6 Months
~~ No14/
Yes1 ;>/ 6 Months
YesT"5"/ e Months
Yes^5~/ 6 Months
Yes"*"5"/ 6 Months
N/A1 1 / Yes 1 6/ 6 Months
40588501 No
No1 2/
No"1"2"/
NoT2~/
Nojpy
N/A11/ Yes 6 Months
No1 4/
YesH"2/ 6 Months
Yes^/ 6 Months
Yes"^/ 6 Months
Yes^/ 6 Months
No2/
40588501 No
In /
«« 2/
No1 ^/
No1 2/
No1 2/
-------
Table A
Generic Data Requirements for Picloram (Cont'd)
Data Requirement
§158.120 Product Chemistry
Test Use
Substance1/ Pattern
Does EPA
Have Data?
Bibliographic Must Additional
Citation Data Be Submitted
Time frame
for
Submission
Physical and Chemical Characteristics (Cont'd)
63-15 - Flammability
63-16 - Explodability
ON
63-17 - Storage Stability
63-18 - Viscosity
Acid-TGAI All
K Salt
TIPA
IOE
TEA
IPA
Acid-TGAI All
K Salt
TIPA
IOE
TEA
IPA
Acid-TGAI All
K Salt
TIPA
IOE
TEA
IPA
Acid-TGAI All
K Salt
TIPA
IOE
TEA
IPA
Yes
no
no
no
no
no
Yes
no
no
no
no
Yes
Ho
no
no
no
no
no
no
no
no
no
No2/
40588501 no
no^ 2/
No1"2/
No"1"2"/
No]]2/
No2/
40588501 No
No /
No /
NoJ27
No2/
40588501 No
No12/
NoT7/
ucT^y
NoW
No2/
YePV
No1"2?"
No1"2"/
No12/
No1"2/
6 Months
-------
Table A
Generic Data Requirements for Picloram (Cont'd)
Timeframe
Test Use Does EPA Bibliographic Must Additional for
Data Requirement Substance1/ Pattern Have Data? citation Data Be Submitted Submission
§158.120 Product Chemistry
Physical and Chemical Characteristics (Cont'd)
63-19 - Miscibility Acid-TGAI All
K Salt
TIPA
IOE
TEA
IPA
No
NO
No
NO
NO
NO
NO2/
Yes18/ 6 Months
No1^7
No1"7/
No^Z/
NoW
J_/Test substance: 88% unregistered technical = acid; 34.7% FI + Potassium salt of picloram = K Salt; triisopropanol-
amine salt of picloram = TIPA; Isooctyl ester of picloram = IOE; Triethylamine salt of picloram = TEA; and
1 isopropanol amine salt of picloram = IPA.
2/Data not required for unregistered technical.
^/Nominal concentrations for active ingredient and each intentionally added inert must be submitted. The name and
upper certified limit must be provided for each impurity or group of impurities for which a certified limit is
required. This information must be submitted on EPA Form 8570-4.
4/The product name, chemical name, nominal concentration, certified limits, CAS Registry Number, and purpose of each
intentionally added inert must be provided for the TIPA, IOE, TEA, and IPA end-use products (EPs). The name and
upper certified limit must be provided for each impurity or group of impurities for which a certified limit is
required for all EPs produced by an integrated formulation system. This information must be submitted on EPA
Form 8570-4.
JS/Complete information must be submitted for the K salt formulation intermediate (FI) and all EPs produced by an
integrated formulation system regarding the nature of the process (batch or continuous), the relative amounts
of beginning materials, the chemical equation for each reaction, reaction conditions, the duration of each step
of the process, purification procedures, and quality control measures. In addition, the name and address of the
manufacturer, supplier, or producer of each beginning material used in the manufacture of the EPs produced by
an integrated formulation system, and information regarding the properties of each beginning material used in
manufacture of the FI and EPs produced by an integrated formulation system must be provided.
6/A detailed discussion of all impurities that are or may be present at >_ 0.1% in all EPs produced by an integrated
formulation system, based on knowledge of beginning materials, chemical reactions (intended and side) in the
manufacturing process, and any contamination during and after production must be submitted.
-------
Table A
Generic Data Requirements for Picloram (Cont'd)
Footnotes (Cont'd)
J7/Five or more representative samples of each of the EPs produced by an integrated formulation system must be analyzed
for the amount of active ingredient and each impurity for which certified limits are required. Complete validation
data {accuracy and precision) must be submitted for each analytical method used.
8/Upper and lower limits for the active ingredient and each intentionally added inert and upper limits for each
impurity present at _>. 0.1% (w/w) and each additional "toxicologically significant" impurity present at < 0.1% (w/w)
are required for the FI and all EPs produced by an integrated formulation system. Limits must be certified, and an
explanation of how each certified limit was established must be provided. Certification will be specifically
required for the toxicologically significant impurity hexachlorobenzene (HCB). Certification must be submitted
on EPA Form 8570-4.
^/Validated certified limits for N-nitroso contaminants are required for all EPs that contain tertiary alkanolamines
or tertiary amines. The nitrosoamines must be identified in six samples of each product; two samples might be
analyzed shortly after production, 3 months after production, and 6 months after production. A method of sensitivity
to 1 ppm of N-nitroso contaminants must be used.
_1_0/Analytical methods must be provided to determine N-nitrosoamines in all EPs containing tertiary alkanolamines
or tertiary amines. The method must be accompanied by validation studies indicating its accuracy and precision.
(JJ/Although product chemistry data may have been submitted in the past, the Agency has determined that these data
must be resubmitted for each pesticide. New requirements have been introduced and previously submitted data must
be updated. Therefore, bibliographic citations for the old data are not applicable.
J_2/These data are not required for EPs produced by an integrated formulation system.
J_3/Data are not required for manufacturing use products (MPs).
J_4/Data are not required because TGAI is a solid at room temperature.
J_5/As required by 40 CFR 158.120 and more fully described in the Pesticide Assessment Guidelines, Subdivision D, data
using a pure (PAI) form of TIPA, IOE, TEA, AND IPA must be submitted.
Jjj/Data are required on pH if the test substance can be diluted or dispersed in water.
J_7/Data on miscibility are required if the product is a liquid.
J_8_/Data on miscibility are required if the product is an emulsifiable liquid and it is to be diluted with petroleum
solvents.
-------
Table A
Generic Data Requirements for Picloram
Data Requirement
Test
Substance
Use
Pattern
Does EPA
Have Data?
Bibliographic
Citation
Must Additional Timeframe
Data Be for
Submitted Submission1/
§158.240 Residue Chemistry
171-2 - Chemical Identity^/
171-3 - Directions for Use
171-4 - Nature of Residue
(Metabolism)
- Plants
171-4 - Nature of Residue
(Metabolism)
- Livestock
171-4 - Residue Analytical
Methods
171-4 - Storage Stability
A
A
PAIRA
PAIRA
and plant
metabolites
TGAI and
metabo-
lites
Partially
Partially
Partially
TEP and
metabo-
lites
Partially
00037880,00041136,
00059411,00111527,
00157171
00023105,00041125,
00161306,00163216
00026748,00026749,
00026750,00026751,
00026752,00026753,
00027288,00035959,
00045363,00045373,
00045374,00045375,
00045376,00045409,
00062818,00078483,
00085060,00111404,
00111407,00131364,
00132986,00156366
00164725,40082701,
40435601
Yeg3,4,5/ 18 Months
Yes6'7'8'9/ 18 Months
Yes10'11'12/ 15 Months
15 Months
-------
Table A
Generic Data Requirements for Picloram (Cont'd)
Must Additional Timeframe
Test Use Does EPA Bibliographic Data Be for
Substance Pattern Have Data? Citation Submitted Submission1/
Data Requirement
§158.240 Residue Chemistry
171-4 - Magnitude of the
Residue in Plants
- Cereal Grains Group14/
o Cereal Grains
- Barley
ON
OD
- Barley Milled
Products
- Oats
- Oat Milled
Products
- Wheat
- Wheat Milled
Products
TEP
EP
TEP
EP
TEP
EP
Partially
No
Partially
No
Partially
No
00036168,00036170,
00036171,00045369,
00128714
Yes15/
00036168,00036170, Yes2£/
00036171,00045369,
00128714
Yes16/
00036168,00036170, Yes^7/
00036171,00045369,
00128714
18 Months
24 Months
18 Months
24 Months
18 Months
Yes18*19/ 24 Months
o Forage, Fodder
and Straw of
the Cereal
Grains Group^0/
-------
Table A
Generic Data Requirements for Picloram (Cont'd)
Must Additional Timeframe
Test Use Does EPA Bibliographic Data Be for
Substance Pattern Have Data? Citation Submitted Submission1/
Data Requirement
§158.240 Residue Chemistry
171-4 - Magnitude of the
Residue in Plants
- Cereal Grains Group (Cont'd)
- Barley TEP
Forage/Straw
- Oat Forage/ TEP
Straw
Partially 00036168,00036170, Yes£V 18 Months
00036171,00128714
Partially 00036168,00036170, Yes^2/ 18 Months
00036171,00128714
- Wheat Forage/
Straw
TEP
Partially 00036168,00036170, Yes23'24/ 18 Months
00036171,00128714
o Grass Forage, TEP A
Fodder and Hay
- Grasses
o Miscellaneous
Commodities
- Flaxseed TEP A
171-4 - Magnitude of the TGAI or A
Meat/Milk/Poultry/Eggs plant
metabolites
Partially
Partially
Partially
00062817r00108862, Yes25>26'27'28/
00108864,00111404, 18 Months
00111482,00111557,
00156366
00085060
00085060
Yes2*/
Yes30/
18 Months
18 Months
J_/Data must be submitted within the indicated timeframe, based on the date of this Guidance Document.
j2/The same chemical identity data are required under 158.120, with emphasis on impurities that could constitute
~ residue problems. Refer to Product Chemistry Data Requirements tables.
J/Data depicting the distribution and metabolism of ring-labeled [14C]picloram in or on wheat forage, grain, and
straw are required. A completely characterized test substance representative of technical picloram (including
impurities) used in commercial formulations must be applied at rates sufficiently high to permit characterization
-------
Table A
Generic Data Requirements for Picloram (Cont'd)
Footnotes (Cont'd)
of l^C-residues. The identities and quantities of residues, including conjugated residues, in or on mature plant
parts must be determined in order to elucidate terminal residues. The registrant may partially satisfy these
data requirements by providing additional data including but not limited to the following: (i) raw data needed
to determine the percentage of the total radioactivity in each tissue recovered by HPLC (total extract volume,
injection volume, total counts in each extract); (ii) the results of TLC analysis of the extracts to permit the
identification of 14c_residues in tne conjunct peaks noted in the HPLC histograms; (iii) hydrolysis, extraction,
and TLC analyses of radioactivity not extracted into sodium hydroxide or into ether; and (iv) data reflecting the
extraction of plant samples with methanol (used to extract the free and conjugated metabolites of picloram as
well as conjugated picloram in the previous study on wheat) and the subsequent identification and quantification
of all terminal residues.
4/Representative samples from these studies must also be analyzed by current or proposed enforcement methods
including Multiresidue Protocols I-IV to ascertain that all residues of concern are determined.
jj/Residue data are required for the impurity hexachlorobenzene (HCB). If detectable levels of HCB are found,
this impurity will be included in the tolerance expression for picloram.
^/Metabolism studies utilizing ruminants are required. Animals must be dosed orally for a minimum of 3 days with
[14c]picloram at a level sufficient to make residue identification and quantification possible. Milk must be
collected twice a day during the dosing period. Animals must be sacrificed within 24 hours of the final dose.
The distribution and identity of residues must be determined in milk, liver, kidney, muscle, and fat. The
-vj registrant may partially satisfy these data requirements by providing additional data including but not limited
O to the following: (i) results of analyses of urine, feces, milk, and tissue extracts by TLC using mobile systems
with different polarities in order to separate all possible residues; (ii) GC-MS chromatograms of radioactive
residues isolated from milk and tissue samples; and (iii) identification of all peaks shown in the GC-MS analyses
of urine and fecal extracts or GC-MS analyses of nonradioactive extracts to determine which peaks represent
radioactive residues.
7/Samples from these studies must also be analyzed using current or proposed enforcement methods to ascertain
that the methods are capable of adequately recovering and identifying all residues of toxicological concern.
8/Data depicting the nature of picloram residues in swine are also required if the required metabolism studies
reveal that the metabolism of picloram in ruminants differs from that in rats.
9/Data are required for HCB. If detectable residues of HCB are observed in animal commodities, then this
impurity will be included in the tolerance expression for picloram.
j.O/Representative plant samples, ruminant tissues, milk, and eggs bearing residues of picloram must be subjected to
analysis by Multiresidue Protocols I, II, III, and IV in PAM Vol. I. These protocols are available from the
National Technical Information Service under Order No. PB203734/AS.
11/The registrant must report the details of the method(s) used to quantitate HCB in plant commodities. The method(s)
used must be capable of detecting HCB levels of _< 1 ppb. Data on recovery of HCB from fortified and apparent
residues in or on untreated control samples must be submitted to validate the method(s).
-------
Table A
Generic Data Requirements for Picloram (Cont'd)
Footnotes (Cont'd)
12/1f the requested data on plant and ruminant metabolism indicate that residues of toxicological concern occur in
plant commodities, ruminant tissues, or milk, methods for data collection and enforcement will be required. EPA has
required, in the sections entitled "Nature of the Residue in Plants" and "Nature of the Residue in Animals"
that representative samples from the metabolism studies be subjected to analyses using all current or proposed
methods for data collection and enforcement, including Methods I, II, and III in the PAM, Vol. II, Pesticide Reg.
Sec. 180.292.
_13/Storage conditions and intervals must be submitted for all samples used to provide the residue data on picloram
and HCB requested in this document. This information must be accompanied by data depicting the percent decline in
residues under the storage conditions and for the intervals specified. Samples bearing field-weathered residues
'" or fortified samples 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 residue data. Storage
conditions for the samples must reflect data submitted previously and in response to the requirements of this
document. The storage intervals selected must allow for reasonable unforeseen delays in sample analysis.
ftH/A crop group tolerance is not appropriate at this time for the following reasons:
""* o Proposed use directions and appropriate supporting residue data must be submitted depicting picloram residues
of concern in or on the additional crop group members corn (fresh sweet corn and dried field corn), rice, and
sorghum.
o Additional data to support the established tolerances for residues of picloram in or on barley, oats, and
wheat (refer to the "Wheat" section for details of the data requirements) must be submitted.
15/Residue and processing data required for wheat will be translated to barley.
16/Residue and processing data required for wheat will be translated to oats.
17/Data depicting picloram residues of concern in or on wheat grain harvested following a single application (made
when the wheat plants have five leaves) of representative SC/L (potassium salt) and EC (triisopropanolamine
salt) formulations (each applied in separate tests) at 0.02 Ib ai/A, using ground and aerial equipment in separate
tests. Residues of HCB in or on these samples must be reported along with the results of analyses for HCB level
of each batch of formulation used in these tests. Tests using the SC/L formulation must be conducted in ID or
MT, MN, OK, SD, and UT, and tests using the EC formulation must be conducted in MT, ND, and/or SD in order to
adequately represent the areas in which these uses are registered.
18/A processing study depicting picloram residues of concern in middlings and in grain dust from the processing of
wheat bearing measurable, weathered residues is required. If residues concentrate in any product, appropriate
food/feed additive tolerances must be proposed.
j-9/If detectable weathered residues of HCB are found in or on wheat grain, a processing study depicting residues
of HCB in milled products (bran, flour, middlings, and shorts), and in grain dust from the processing, will be
required. Analyses for HCB levels must be reported for each formulation used to treat the grain used in these
processing studies.
-------
Table A
Generic Data Requirements for Picloram (Cont'd)
Footnotes (Oont'd)
20/A crop group tolerance is not appropriate at this time for the following reasons:
o Proposed use directions and appropriate supporting residue data must be submitted depicting picloram residues of
concern in or on the additional crop group members corn forage and fodder and the forage, hay, and straw of one
other group member.
o Additional data to support the established tolerances for residues of picloram in or on the forage and straw of
barley, oats, and wheat (refer to the "Wheat Forage, Hay, and Straw" section for details of the data requirement)
must be submitted.
^I/Residue data required for wheat forage and straw will be translated to barley forage and straw.
22/Residue data required for wheat forage and straw will be translated to oat forage and straw.
23/Data depicting picloram residues of concern in or on wheat forage and straw harvested following a single application,
made when the plants have five leaves of representative SC/L (potassium salt) and EC (triisopropanolamine salt)
formulations (each applied in separate tests) at 0.02 Ib ai/A, using ground and aerial equipment in separate tests
must be submitted. Residues of HCB in or on these samples must be reported along with the results of analyses for
HCB levels of each batch of formulation used in these tests. Tests using the SC/L formulation must be conducted in
ID or MT, MN, OK, SD, and UT, and tests using the EC formulation must conducted in MT, ND, and/or SD in order to
j adequately represent the areas in which these uses are registered. The registrant must propose a PHI and the
) available data must reflect this interval.
J24/An appropriate tolerance must be proposed and residue supporting data must be submitted for the raw agricultural
commodity (RAC) wheat hay.
25/Data depicting picloram residues of concern in or on pasture and rangeland grasses and hay from grasses harvested
at regular intervals following application of a representative P/T formulation of the potassium salt of picloram
(each applied in separate tests) at 4 Ib ai/A must be submitted. Residues of HCB in or on these samples must be
reported along with the results of analyses for HCB levels of each batch of formulation used in these tests. Tests
must be conducted in CA, CT, GA (representative of AL), HI, MO (representative of AR, IA, and KS), PA,
(representative of OH and NJ), TN (representative of NC), and TX. (representative of OK and NM) to adequately
represent the areas in which this use is registered.
26/Data depicting residues of concern in or on pasture and rangeland grasses and hay from grasses harvested on the day
of application of a representative SC/L formulation of the potassium salt of picloram (applied by aerial and ground
equipment in separate tests) at 4 Ib ai/A must be submitted. Tests must be conducted in NE (also representing IA,
MO, SD, and WY). Also, data must be submitted reflecting application at 2 Ib ai/A; these tests must be conducted in
MT (representing ID and ND), and AZ or OT (representsting NV) to adequately represent the States in which this
formulation class is registered. Residues of HCB in or on these samples must be reported along with the results
of analyses for HCB level of each batch of formulation used in these tests.
27/Data depicting picloram residues of concern in or on pasture and rangeland grasses and grass hay harvested on the
day of application of the 0.54 Ib/gal EC formulation at 0.54 ai/A, in 10 gal of oil-water using ground equipment,
and in 1 gal using aerial equipment; finished sprays containing 0.5% of an agricultural surfactant must be
submitted. The tests must be conducted in TX which is representative of the area in which this use is registered
(NM, OK, and TX.).
-------
Table A
Generic Data Requirements for Picloram (Cont'd)
Footnotes (Cont'd)
Residues of HCB in or on these samples must be reported along with the results of analyses for HCB level of each
batch of formulation used in these tests.
^28/The registrant must amend all pertinent product labels to include a maximum number of applications per season or a
maximum seasonal application rate. The requested residue data must reflect the proposed maximum rate or number of
applications.
22/Data depicting residues of HCB in or on flaxseed and flax straw harvested following application of the 2 Ib/gal
SC/L formulation of the potassium salt of picloram at 0.016 Ib ai/A, made when plants are 3 inches tall must be
submitted. Each batch of product used in the tests must be analyzed for HCB level and the results of the analyses
must be reported along with the residue data. The tests must be conducted in ND where this use in registered.
^0/Data requirements regarding the magnitude of residues in animal products will not be determined until all requested
data regarding metabolism in animals and magnitude of residues in feed items have been received. On receipt of
the data on HCB levels in feed items, the requirements for data on HCB in animal commodities will be determined.
-------
Table A
Generic Data Requirements for Picloram
§158.
ACUTE
81-1
81-2
81-3
81-4
Data Requirement
135 Toxicology
TESTING
- Acute Oral Toxicity
- Rat
- Acute Dermal Toxicity
- Rabbit
- Acute Inhalation
Toxicity - Rat
- Primary Eye Irritation
- Rabbit
Test use
Substance1/ Pattern
TGAI-Acid A,B,G
K Salt
IOE
TIPA
TEA
IPA
TGAI-Acid A,B,G
K Salt
IOE
TIPA
TEA
IPA
TGAI-Acid A,B,G
K Salt
IOE
TIPA
TEA
IPA
TGAI-Acid A,B,G
K Salt
IOE
TIPA
TEA
IPA
Does EPA
Have Data?
Yes
Yes
Yes
No
No
No
Yes
Yes
Yes
No
No
No
Yes
Yes
Yes
No
No
No
Yes
Yes
Yes
No
No
No
Bibliographic
Citation
40479413
40479401
40479407
40479414
40479402
40479408
40479415
40479403
40479409
40479416
40479404
40479410
Must Additional
Data
Be Submitted
NO
NO
No
Yes
Yes
Yes
No
No
NO
Yes
Yes
Yes
No
NO
No
Yes
Yes
Yes
No
No
NO
Yes
Yes
Yes
Timeframe
for
Submission2/
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
-------
Table A
Generic Data Requirements for Picloram
Data Requirement
§158.135 Toxicology
ACUTE TESTING (Con't)
81-5 - Primary Dermal
Irritation - Rabbit
81-6 - Dermal Sensitization -
Guinea Pig
-vl
cn
81-7 - Acute Delayed
Neurotoxicity - Hen
Test Use
Substance1/ Pattern
TGAI-Acid A,B,G
K Salt
IDE
TIPA
TEA
IPA
TGAI-Acid A,B,G
K Salt
IDE
TIPA
TEA
IPA
TGAI-Acid A,B,G
K Salt
IDE
TIPA
TEA
IPA
Does EPA
Have Data?
Yes
Yes
Yes
No
No
NO
Yes
Yes
Yes
No
No
No
No
No
NO
NO
No
NO
Must Additional
Bibliographic Data
Citation Be Submitted
40479417 No
40479405 No
4047941 1 No
Yes
Yes
Yes
40479418 No
40479406 No
40479412 No
Yes
Yes
Yes
No3/
No?/
No^/
NO?/
NO?/
NO?/
Timeframe
for
Submissions/
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
-------
Table A
Generic Data Requirements for Picloram (Cont'd)
Data Requirement
Test Use
Substance^ Pattern
Must Additional Timeframe
Does EPA Bibliographic Data for
Have Data? Citation Be Submitted Submission?/
§158.135 Toxicology
SUBCHRONIC TESTING
82-1 - 90-Day Feeding
- Rodent
- Nonrodent (Dog)
ON
TGAI
Acid,K Salt
IOE
TEA
IPA
TIPA
Acid,K Salt
IOE
TEA
IPA
TIPA
A,B,G
82-2 - 21-Day Dermal - Rabbit TGAI
Acid,K Salt
IOE
TEA
IPA
TIPA
82-3 - 90-Day Dermal - Rabbit TGAI
Acid,K Salt
IOE
TEA
IPA
TIPA
A,B,G
A,B,G
Yes
NO
NO
NO
NO
Yes
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
00110537
00110534
NO
Yes
Yes
Yes
Yes
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No4/
NG4/
Nq4/
Nq4/
No4/
15 Months
15 Months
15 Months
15 Months
18 Months
18 Months
18 Months
18 Months
12 Months
12 Months
12 Months
12 Months
12 Months
-------
Table A
Generic Data Requirements for Picloram (Cont'd)
§158
Data Requirement
.135 Toxicoloqy
Test use
Substance.}/ Pattern
Does EPA
Have Data?
Must Additional Timef rame
Bibliographic Data for
Pit-aHon PP fining H-Prt RiihmiRsinri2/
SUBCHRONIC TESTING (Cont'd)
82-4
82-5
- 90-Day Inhalation
- Rat
- 90-Day Neurotoxicity
- Hen
- Mammal
TGAI A,B,G
Acid,K Salt
IOE
TEA
IPA
TIPA
TGAI A,B,G
Acid,K Salt
IOE
TEA
IPA
TIPA
NO
NO
NO
NO
NO
No
NO
NO
NO
NO
N04/
NC4/
N04/
Nq4/
Nq4/
N05/
N05/
N05/
N05/
No5/
CHRONIC TESTING
83-1
- Chronic Toxicity
- 2 Species
- Rodent
- Nonrodent (Dog)
TGAI A,B,G
Acid,K Salt
IOE
TEA
IPA
TIPA
Acid,K Salt
IOE
TEA
IPA
TIPA
Yes
NO
NO
NO
NO
NO
NO
NO
NO
NO
00155940 NO
Reserved])/
Reserved]*/.
Reserved^/
Reserved])/
YesT/
Reserved])/
Reserved^/
Reserved])/
Reserved6/
-------
Table A
Generic Data Requirements for Picloram (Cont'd)
Data Requirement
Test Use
Substance!/ Pattern
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data
Be Submitted
Timeframe
for
Submission!^
S158.135 Toxicology
CHRONIC TESTING (Cont'd)
83-2 - Oncogenicity Study
- 2 Species
- Rat (preferred)
- Mouse (preferred)
CO
83-3 - Teratogenicity
- 2 Species
- Rat
- Rabbit
TGAI
Acid,K Salt
IOE
TEA
IPA
TIPA
Acid,K Salt
IOE
TEA
IPA
TIPA
TGAI
Acid,K Salt
IOE
TEA
IPA
TIPA
Acid,K Salt
IOE
TEA
IPA
TIPA
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
Yesi/
Reservedjj/
Reserved])/
Reserved*)/
Reserved])/
Yes!/
Reserved])/
Reserved]}/
Reservedj[/
ReservedG/
50 Months
50 Months
Yesi/
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
15 Months
15 Months
15 Months
15 Months
15 Months
15 Months
15 Months
15 Months
15 Months
15 Months
-------
Table A
Generic Data Requirements for Picloram (Cont'd)
Data Requirement
Test Use
Substancei/. Pattern
Must Additional Timeframe
Does EPA Bibliographic Data for
Have Data? Citation Be Submitted Submission?/
§158.135 Toxicology
CHRONIC TESTING (Cont'd)
83-4 - Reproduction - Rat
2-Generation
MUTAGENIC TESTING
-2 - Gene Mutation
(Ames Test)
TGAI A,B,G
Acid,K Salt
IOE
TEA
IPA
TIPA
TGAI A,B,G
Acid,K Salt
IOE
TEA
IPA
TIPA
84-2 - Structural Chromosomal TGAI A,B,G
Aberration
Acid,K salt
IOE
TEA
IPA
TIPA
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
Yes
No
NO
No
NO
Yes
Reserved6/
Reserved^/
Reserved*)/
ReservedS/
00098322
No
Yes
Yes
Yes
Yes
39 Months
Yes!?/
Yes
Yes
Yes
Yes
9 Months
9 Months
9 Months
9 Months
9 Months
12 Months
12 Months
12 Months
12 Months
-------
Table A
Generic Data Requirements for Picloram (Cont'd)
Data Requirement
Test Use
Substance!/ Pattern
Must Additional Timeframe
Does EPA Bibliographic Data for
Have Data? Citation Be Submitted Submission?/
§158.135 Toxicology
MUTAGENIC TESTING (Cont'd)
84-2 - Other Mechanisms of
Mutagenicity
A,B,G
SPECIAL TESTING
85-1 - General Metabolism
TGAI
Acid,K Salt
IOE
TEA
IPA
TIPA
PAI or TGAI A,B,G
NO
NO
NO
NO
NO
Yes
Yes
Yes
Yes
Yes
12 Months
12 Months
12 Months
12 Months
12 Months
oo
o
Acid,K Salt
IOE
TEA
IPA
TIPA
Partially 00098321
No
NO
NO
NO
Yes!!/
Yes
Yes
Yes
Yes
24 Months
24 Months
24 Months
24 Months
24 Months
I/Test Substance: Technical grade = acid; Potassium salt of picloram = K Salt; Isooctyl ester = IOE;
Triethylamine salt of picloram = TEA; Isopropanolamine salt of picloram = IPA; and Triisopropanolamine salt of
picloram = TIPA.
VData must be submitted within the indicated timeframe, based on date of this Guidance Document.
3/This test is required only for compounds which are organophosate inhibitors of cholinesterase, or related to
such inhibitors or metabolites of such inhibitors. Picloram, its esters, salts, or amines are not organophosates;
therefore, these data are not required.
_4/This study is not required based on existing use patterns.
5/This study is not required since an acute neurotoxicity study is not required for this compound and there is no
evidence of neurotoxicity in mammalian species.
-------
Table A
Generic Data Requirements for Picloram (Cont'd)
Footnotes (Cont'd)
6/Requirement reserved. Required if measurable residues of the particular amine or ester group are present on the
RACs or processed foods or if basic toxicology studies required show differences in toxic effect(s) compared
with picloram and/or its organic salts.
7/This study (MRID No. 40834301) was submitted too late to be included in this standard.
8/Rodent studies should be in the Osborne-Mendel rat and the B6C3F1 mouse using commercially available technical
grade picloram uncontaminated with potentially tumorigenic levels of HCB. The registrant should consult with
the Agency in order to establish appropriate doses for these studies.
9/A new study with rabbits is needed or additional information clarifying abnormalities noted in the previously
submitted study (MRID No. 00138703).
10_/Data and raw report materials supporting the qualitative statements made on the previous study (MRID No. 00138793)
must be submitted or a new study must be submitted.
D/This study is acceptable for males. Only females must be tested in the additional study.
-------
Table A
Generic Data Requirements for Picloram
Data Requirement
§158.290 Environmental Fate
DEGRADATION STUDIES - LAB
161-1 - Hydrolysis
Photodeqradation
161-2 - In Water
161-3 - On Soil
161-4 - In Air
CO
rx METABOLISM STUDIES - LAB
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
MOBILITY STUDIES
Test
Substance
PAIRA
PAIRA
PAIRA
PAIRA
PAIRA
PAIRA
PAIRA
PAIRA
163-1 - Leaching and PAIRA
Adsorption/Desorption
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
TEP
TEP
Use
Pattern
A,B,D,G
A,B,D,G
A,G
A
A,B,G
A
D,G
D
A,B,D,G
A
A
Does EPA
Have Data?
Yes
NO
NO
NO
Yes
Yes
Partially
NO
NO
NO
NO
Must Additional
Bibliographic Data
Citation Be Submitted
00131365 No
00164749
Yes
Yes
No!/
00128976 No
40178601
00128976 NO
00128976 Yesi/
Yes!/
Yesi/
Nb!/
NO!/
Timeframe
for
Submission!/
9 Months!/
9 Months2/
27 Months
27 Months
12 Months
-------
Table A
Generic Data Requirements for Picloram (Cont'd)
CO
Test Use
Data Requirement Substance Pattern
§158.290 Environmental Fate
DISSIPATION STUDIES - FIELD
164-1 - Soil TEP A,B
164-2 - Aquatic (Sediment) TEP D
1 64-3 - Forestry TEP G
1 64-4 - Combination and
Does EPA
Have Data?
No
NO
No
N/A
Must Additional
Bibliographic Data
Citation Be Submitted
Yes£/
YesV
Yes8/
NoV
Timeframe
for
Submission1/
27 Months
27 Months
27 Months
__
Tank Mixes
164-5 - Soil, Long-Term TEP
ACCUMULATION STUDIES
165-1 - Rotational Crops PAIRA
(Confined)
165-2 - Rotational Crops TEP
(Field)
165-3 - Irrigated Crops TEP
165-4 - In Fish PAIRA
165-5 - In Aquatic Nontarget TEP
Organisms
§158.140 Reentry Protection
132-1 - Foliar Dissipation TEP
132-2 - Soil Dissipation TEP
A No
A No
A No
D No
A,B,D,G Partially
D,G No
A,B,D,G NO
A,B,D,G NO
00128947
Reserved10/
Yes_^V 39 Months
Reserved1^/
YesJ_V 39 Months
Yes^V 12 Months
Reserved15/
No1*/
-------
Table A
Generic Data Requirements for Picloram (Cont'd)
Data Requirement
Test Use
Substance Pattern
Must Additional Timeframe
Does EPA Bibliographic Data for
Have Data? Citation Be Submitted Submission1/
CO
S158.140 Reentry Protection (Cont'd)
133-3 - Dermal Exposure TEP
133-4 - Inhalation Exposure TEP
S158.142 Spray Drift
201-1 - Droplet Size TEP
Spectrum
201-1 - Drift Field TEP
Evaluation
S 158. 75 Other Exposure Data
Mixer/Loader and Applicator
Exposure Data
Groundwater Monitoring Data
A,B,D,G
A,B,D,G
A,B,D,G
A,B,D,G
No
NO
NO
No
No
No
NoW
18 Months
18 Months
No
Yes18/ 10 Months
I/Data must be submitted within the indicated timeframe, based on the date of the Guidance Package.
2/Data are needed for both the isooctyl ester (IOE) and potassium (K) salt forms of picloram. For the
aerobic aquatic studies, the use on outer ditch banks is an aquatic use and must be supported by the
required data or withdrawn.
3/No data are required because of the relatively low vapor pressure of picloram salt form. No data are
required for the IOE form because there are no terrestrial food uses presently registered for this form.
4/Additional data are needed for the IOE form of picloram, to support the aquatic use on ditchbanks or
this use must be withdrawn.
J5/Data needed on both the K salt and IOE forms. An adsorption/desorption (batch equilibrium) type of
mobility study must be conducted on four soil types at four concentrations.
-------
Table A
Generic Data Requirements for Picloram (Cont'd)
Footnotes (Cont'd)
6/Nine soil dissipation studies are needed covering the following test parameters:
Chemical Form. Use Pattern Location
1. Triisopropanolamine salt
2. Isooctyl ester
3. Potassium salt
4. Potassium salt
5. Potassium salt
Rights-of-way
Rights-of-way
Small grain
Nonfood
Pasture/Rangeland
Anywhere in U.S.
Anywhere in U.S.
ID, OR, or WA
Anywhere in U.S.
Anywhere in U.S.
(2 sites)
(2 sites)
(2 sites)
(2 sites)
These studies must be conducted at the maximum application rate as specified by the product labels. The nine
studies required for the Terrestrial Field Dissipation requirement include all three registered formulations
oo of picloram and the most typical use patterns. The potassium salt formulation should not be mixed with another
01 pesticide, whereas the triisopropanolamine salt formulation must include 2,4-D and the isooctyl ester formu-
lation must include triclopyr, as these formulations typically contain these compounds.
7/Additional data are needed to support the use of the soluble concentrate/liquid formulation (TIPA) in ditchbanks.
8/Data are needed to support forest site preparation by broadcast application of the K salt form in two represen-
tative areas of the United States, the South and Northwest.
9/Data for this requirement are no longer necessary.
10/Data may be required on the K and IOE forms of picloram if the results from the field dissipation studies demonstrate
that residues do not reach 50 percent dissipation in soil prior to the recommended subsequent application.
U/Data are needed for the K form of picloram only. The IOE form is not presently registered for use on terrestrial
food crops.
j.2/Pending the results of an acceptable confined rotational crop study.
13/Data are required for both the K and IOE forms of picloram, to support the aquatic use on ditchbanks or the use
must be withdrawn.
JL4/Additional data are needed for the IOE form of picloram.
15/Reserved pending the results of an acceptable fish accumulation study with the IOE form of picloram.
16/Picloram does not meet the toxicology requirements of Part 158.140 of Title 40 of the Code of Federal
Regulations.
jLT/The Spray Drift Droplet Spectrum and Field Evaluation may be done together in order to evaluate the droplet spectra
that are associated with actual field use patterns. The droplet spectrum study is to be performed to reflect the
nozzle and other equipment types to be used in the application of picloram to pasture/rangeland, rights-of-way,
and forestry uses. The Spray Drift Field Evaluation is to be performed to reflect the application of equipment,
use pattern, and typical locations of use, which include different weather factors, in the application of picloram
for these uses.
-------
Table A
Generic Data Requirements for Picloram (Cont'd)
Footnotes (Cont'd)
Id/The prospective study is due to be submitted by July 1989. The Agency reserves the right to request further
groundwater monitoring studies, if (1) after rview of the protocol for the prospective study it is determined
that the study is not adequately designed to answer the Agency's questions regarding the groundwater contamination
hazard by picloram; or (2) after submission of the prospective study it is determined that a more widespread
characterization of the groundwater contamination hazard with picloram is needed.
CO
ON
-------
Table A
Generic Data Requirements for Picloram
00
Test Use
Data Requirement Substance Pattern
§158.
Does EPA
Have Data?
Must Additional Timeframe
Bibliographic Data for
Citation Be Submitted Submission!*
145 Wildlife and Aquatic Orqanisms
AVIAN AND MAMMALIAN TESTING
71-1
71-2
71-3
71-4
71-5
71-5
- Acute Avian Oral
- Avian Subacute
Dietary Toxicity
- Upland Game Bird
- Waterfowl
- Wild Mammal Toxicity
- Avian Reproduction
- Upland Game Bird
- Waterfowl
- Simulated Field Testing
- Mammals
- Birds
- Actual Field Testing
- Mammals
- Birds
TGAI A,B,G
Acid
K Salt
TGAI A,B,G
Acid
K Salt
IOE
Acid
TGAI A,B,G
TGAI A,B,G
TEP A,B,G
TEP A,B,G
Yes
Yes
Yes
Yes
Yes
Yes
NO
NO
NO
NO
NO
NO
NO
00157173 No!/
00157174 No?/
00022923 No?/
00164727
00164726
00022923 No!/
No!/
NO!/
Noi/
NO!/
NO5/
NOV
no5/
-------
Table A
Generic Data Requirements for Picloram (Cont'd)
Data Requirement
S158.145 Wildlife and Aquatic
AQUATIC ORGANISMS TESTING
72-1 - Freshwater Fish LCso
- warmwater
- Coldwater
72-2 - Acute Toxicity to
oo Freshwater
CO Invertebrates
72-3 - Acute Toxicity to
Estuarine and Marine
Organisms
- Fish
- Mollusk
- Shrimp
72-4 - Fish and Early Life
Stage and Aquatic
Test use Does EPA
Substance Pattern Have Data?
Organisms
TGAI A,B,G
Acid Yes
K Salt Yes
IOE Yes
Acid Yes
K Salt Yes
TGAI A,B,G Yes
(Acid)
TGAI A,B,G Yes
TGAI A,B,G Yes
Bibliographic
Citation
00129076
00041475
40094602
00129076
00129078
00041475
00129076
00141979
00151783
40094602
00111560
00129073
00129085
00151784
Must Additional Timeframe
Data for
Rp Snhpri ft-prl puhmiSR-jnnl/
NO?/
NO?/
NO?/
NO?/
NQi/
Invertebrate Life
Cycle
72-5 - Fish Life Cycle
TGAI
A,B,G
No
NO
-------
Table A
Generic Data Requirements for Picloram (Cont'd)
Data Requirement
Test use
Substance Pattern
Must Additional
Does EPA Bibliographic Data
Have Data? _ citation _ Be Submitted
Timeframe
for
Submission!!/
S158.145 Wildlife and Aquatic Organisms
AQUATIC ORGANISMS TESTING (Cont'd)
72-6 - Aquatic Organism
Accumulation
- Crustacean
- Fish
- Insect Nymph
- Mollusk
CD 72-7 - Simulated Field Testing TEP
^O - Aquatic Organisms
72-7 - Actual Field Testing
- Aquatic Organisms
TGAI, PAI A,B,G
or Degrada-
tion Product
Yes
00128947
No
NO
No
NO*/
I/Data must be submitted within the indicated timeframe, based on the date of the Guidance Document.
2/Additional testing will not be required on picloram derivatives (potassium salt, isooctyl ester), because of the
similarity in toxicity values that were noted in available data.
3/These data are required if available acute toxicology data indicate an acute hazard. Available data do not
trigger this requirement.
4/These data are required only when the label recommends multiple applications. Picloram labels do not recommend
multiple applications.
5/These data are required if available acute data on birds and mammals indicate an acute hazard. The available
data do not trigger these requirements.
6/These studies are required if available acute toxicology data on aquatic organisms indicate an acute hazard.
Available data do not trigger these requirements.
-------
Table A
Generic Data Requirements for Picloram (cont'd)
MD
§158.
121-1
Data Requirement
150 Plant Protection
- TARGET AREA
PHYTOTOXICITY
Test use
Substance Pattern
EP
B
Must Additional
Does EPA Bibliographic Data
Have Data? Citation Be Submitted
No
HOj,
Timeframe
for
Submission^/
NONTARGET AREA PHYTOTOXICITY
121-1
122-1
122-2
123-1
123-1
123-2
124-1
124-2
TIER I
- Seed Germination/
Seedling Emergence
- Vegetative vigor
- Aquatic Plant Growth
TIER II
- Seed Germination/
Seedling Emergence
- Vegetative Vigor
- Aquatic Plant Growth
TIER III
- Terrestrial Field
- Aquatic Field
TGAI
TGAI
TGAI
TGAI-Acid
K Salt
IOE
TGAI-Acid
K Salt
IOE
TGAI-Acid
K Salt
IOE
TEP
TEP
B
B
B
B
B
B
B
B
B
B
B
No
No
No
No
No
No
No
No
No
NO
NO
No
No
NO
NoV
NoV
NoV
YesV
Yes*/
Yes*/
Yes4/
Yes*/
Yes*/
YesV
Yes*/
Yes*/
Reserved V
Reserved V
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
-------
Table A
Generic Data Requirements for Picloram (Cont'd)
§158.150 Plant Protection Footnotes
jyData must be submitted within the indicated timeframe based on the date of the Guidance Document.
2/Hot required because picloram is not in Special Review and there are no current health considerations.
_3/Not required because the Agency is requiring Tier II testing.
_4/The testing will be required on the technical active ingredient for each derivative (acid, potassium (K) salt,
and isooctyl ester), because picloram is a herbicide and phytotoxicity testing is required to determine hazard to
nontarget plants.
j>/This requirement is reserved pending results of Tier II testing.
-------
Table A
Generic Data Requirements for Picloram
Must Additional Timeframe
Test Use Does EPA Bibliographic Data for
Substance Pattern Have Data? Citation Be Submitted Submission1/
Data Requirement
§158.155 Nontarget Insect
NONTARGET INSECT TESTING - POLLINATORS
141-1 - Honey Bee Acute
Contact Toxicity
141-2 - Honey Bee - Toxicity
of Residues on Foliage
141-4 - Honey Bee Subacute
Feeding Study
TGAI-Acid
K Salt
TEA Salt
IOE Salt
TIPA Salt
IPA Salt
TEP
A,B,G
A,B,G
(Reserved)*/
141-5 - Field Testing for
Pollinators
TEP
A,B,G
NONTARGET INSECT TESTING - AQUATIC INSECTS
142-1 - Acute Toxicity to
Aquatic Insects
142-2 - Aquatic Insect Life
Cycle Study
142-3 - Simulated or Actual
Field Testing for
Aquatic Insects
143-1 - NONTARGET INSECT
thru TESTING - PREDATORS
143-3 - AND PARASITES
(Reserved)^/
(Reserved )£/
(Reserved)^/
(Reserved)6/
Yes
No
No
No
No
No
No
No
00036935
No
YesV
Yes?/
Yes?/
Yes?/
Yes?/
Reserved3/
9 Months
9 Months
9 Months
9 Months
9 Months
Reserved^/
-------
Table A
Generic Data Requirements for Picloram (Cont'd)
§158.590 Nontarget Insect Footnotes
J/Data must be submitted within the indicated timeframe, based on date of this Guidance Document.
2/the data are required for outdoor uses which may result in exposure of honey bees to the pesticide. Testing is
required on picloram derivatives (potassium (K) salt, triethylamine (TEA) salt, isooctyl ester (IOE), triiso-
propanolamine (TIPA) salt, and isopropylamine salt (IPA)).
^/Requirement for these data will depend upon the result of acute studies.
VThis requirement reserved pending development of test methodology.
S/fhis requirement will depend upon results of lower-tier testing.
6/These requirements reserved pending Agency decision as to whether the data requirement should be established.
-------
Table B
Product-Specific Data Requirements for Manufacturing-Use 'Products and Formulation
Intermediates Containing Picloram '
Data Requirement
§158.120 Product Chemistry
Test Use
Substance1/ Pattern
Does EPA
Have Data?
Must Additional Timeframe
Bibliographic Data for
Citation Be Submitted Submission2/
Product Identity and Composition
61-1 - Product Identity
and Disclosure of
Ingredients
61-2 - Description of
Beginning Materials
vO and Manufacturing
•£=» process
61 -3 - Discussion of
Formation of
Impurities
MP All
K Salt
TIPA
IDE
TEA
IPA
MP All
K Salt
TIPA
IDE
TEA
IPA
MP All
K Salt
TIPA
IDE
TEA
IPA
No
No
No
No
No
NO
NO
No
No
No
Yes
No
No
No
No
Yes-V
Yes*/
Yes*/
Yes*/
Yes*/
YesV
Yes^/
YesV
YesV
YesV
00154235 No
Yes^/
Yego/
Yes"/
Yes"5"/
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
-------
Table B
Product-Specific Data Requirements for Manufacturing-Use Products and Formulation
Intermediates Containing Picloram (Cont'd)
§158.
Data Requirement
120 Product Chemistry
Analysis and Certification of
62-1
62-2
62-3
63-2
- Preliminary Analysis
- Certification of
Limits
- Analytical Methods
to Verify Certified
Limit
- Color
Test Use
Pnhsfanr-pl/ Paht-.prn
Product Ingredients
MP All
K Salt
TIPA
IOE
TEA
IPA
MP All
K salt
TIPA
IOE
TEA
IPA
MP All
K Salt
TIPA
IOE
TEA
IPA
MP All
K salt
TIPA
IOE
TEA
IPA
Does EPA
Have Data?
(Cont'd)
Yes
NO
NO
NO
No
Partially
NO
NO
NO
NO
Yes
NO
Yes
NO
Yes
Yes
NO
No
No
No
Bibliographic
Citation
00154235
00154235
00154235
40588501
00154235
40588501
00154235
40588501
40588501
Must Additional
Data
Be Submitted
NO
Yesl/
YesZ/
Yesl/
YesZ/
Yes§/
yp>g8f9/
Yesi*/
YesitS/
Yes§/
NO
YesW
NO
YeslP./
NO
NO
Yes
Yes
Yes
Yes
Timeframe
for
Submission2/
12 Months
12 Months
12 Months
12 Months
12 Months
12 Months
12 Months
12 Months
12 Months
12 Months
12 Months
6 Months
6 Months
6 Months
6 Months
-------
Table B
Product-Specific Data Requirements for Manufacturing-use Products and Formulation
Intermediates Containing Picloram (Cont'd)
Data Requirement
Test Use
Substance1/ Pattern
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data
Be Submitted
Timeframe
for
Submission^/
§158.120 Product Chemistry
Analysis and Certification of Product Ingredients (Cont'd)
ON
63-3 - Physical State
63-4 - Odor
63-7 - Density, Bulk
Density, or
Specific Gravity
63-12 - pH
MP
K Salt
TIPA
IDE
TEA
IPA
MP
K Salt
TIPA
IDE
TEA
IPA
MP
K Salt
TIPA
IOE
TEA
IPA
MP
K Salt
TIPA
IOE
TEA
IPA
All
All
All
All
Yes
No
No
NO
NO
Yes
No
NO
No
No
Yes
No
No
NO
NO
Yes
No
No
No
No
40588501
40588501
40588501
40588501
No
Yes
Yes
Yes
Yes
No
Yes
Yes
Yes
Yes
No
Yes
Yes
Yes
Yes
No
Yes
Yes
Yes
Yes
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
-------
Table B
Product-Specific Data Requirements for Manufacturing-Use Products and Formulation
Intermediates Containing Picloram (Cont'd)
Data Requirement
§158.120 Product Chemistry
Analysis and Certification of
63-14 - Oxidizing or
Reducing Action
63-15 - Flammability
63-16 - Explodability
63-17 - Storage Stability
Test Use
Substance V Pattern
Product Ingredients
MP All
K Salt
TIPA
IOE
TEA
IPA
MP All
K Salt
TIPA
IOE
TEA
IPA
MP All
K Salt
TIPA
IOE
TEA
IPA
MP All
K Salt
TIPA
IOE
TEA
IPA
Does EPA
Have Data?
(Cont'd)
Yes
No
No
No
No
Yes
No
No
No
No
Yes
No
No
No
No
Yes
No
No
No
No
Must Additional
Bibliographic Data
Citation Be Submitted
40588501 NO
Yes
Yes
Yes
Yes
40588501 No
Yes
Yes
Yes
Yes
40588501 No
Yes
Yes
Yes
Yes
40588501 No
Yes
Yes
Yes
Yes
Time frame
for
Submission2/
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
15 Months
15 Months
15 Months
15 Months
-------
Table B
Product-Specific Data Requirements for Manufacturing-Use Products and Formulation
Intermediates Containing Picloram (Cont'd)
Data Requirement
Test Use
Substance1/ Pattern
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data
Be Submitted
Timeframe
for
Submission^/
§158.120 Product Chemistry
Analysis and Certification of Product Ingredients (Cont'd)
63-18 - Viscosity MP All
K Salt
TIPA
IOE
TEA
IPA
63-19 - Miscibility MP All
K Salt
j TIPA
5 IOE
TEA
IPA
Yes
No
NO
No
No
Yes
No
NO
NO
NO
40588501 NO
YesW
Yes1"2/
Yes 1 2/
YesW
40588501 No
YesW
YesW
Yes"17/
YesW
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
J_/Test Substance: Potassium salt of picloram = K Salt,- Triisopropanolamine salt of pic lor am = TIPAj Isooctyl ester =
IOE; Triethylamine salt of picloram = TEA; and Isopropanolamine salt of picloram = IPA.
2/Data must be submitted within the indicated timeframe, based on date of this Guidance Document.
^/Nominal concentrations for active ingredient and each intentionally added inert must be submitted. The name and
upper certified limit must be provided for each impurity or group of impurities for which a certified limit is
required. This information must be submitted on EPA Form 8570-4.
j4/The product name, chemical name, nominal concentration, certified limits, CAS Registry Number, and purpose of each
intentionally-added inert must be provided for the TIPA, IOE, TEA, AND IPA end-use products (EPs). The name and
upper certified limit must be provided for each impurity or group of impurities for which a certified limit is
required for all EPs produced by an integrated formulation system. This information must be submitted on EPA Form
8570-4.
^/Complete information must be submitted for the K salt and all EPs produced by an integrated formulation system
regarding the nature of the process (batch or continuous)? the relative amounts of beginning materials, the
-------
Table B
Product-Specific Data Requirements for Manufacturing-Use Products and Formulation
Intermediates Containing Picloram (Cont'd)
Footnotes (Cont'd)
chemical equation for each reaction, reaction conditions, the duration of each step of the process, purification
procedures, and quality control measures. In addition, the name and address of the manufacturer, supplier, or
producer of each beginning material used in the manufacture of the EPs produced by an integrated formulation system,
and information regarding the properties of each beginning material used in the manufacture of the K salt and EPs
produced by an integrated formulation system must be provided.
6/A detailed discussion of all impurities that are or may be present at j> 0.1% in all EPs produced by an integrated
formulation system, based on knowledge of beginning materials, chemical reactions (intended and side) in the
manufacturing process and any contamination during and after production must be submitted.
7/Five or more representative samples of each of the EPs produced by an integrated formulation system must be analyzed
for the amount of active ingredient and each impurity for which certified limits are required. Complete validation
data (accuracy and precision) must be submitted for each analytical method used.
j8/Upper and lower limits for the active ingredient and each intentionally added inert and upper limits for each
impurity present at _>. 0.1% (w/w) and each additional "toxicologically significant" impurity present at < 0.1%
(w/w) are required for the K salt and all EPs produced by an integrated formulation system. Limits must be certified
and an explanation of how each certified limit was established must be provided. Certification will be specifically
required for the toxicologically significant impurity hexachlorobenzene (HCB). Certification must be submitted on
EPA Form 8570-4.
' ^/Validated certified limits for N-nitroso contaminants are required for all EPs that contain tertiary alkanolamines
or tertiary amines. The nitrosamines must be identified in six samples of each product; two samples must be
analyzed shortly after production, 3 months after production, and 6 months after production. A method of sensitivity
to 1 ppm of N-nitroso contaminants must be used.
^0/Analytical methods must be provided to determine N-nitrosoamines in all EPs containing tertiary alkanolamines or
tertiary amines. The method must be accompanied by validation studies indicating the accuracy and precision.
_1_1_/Data are required on pH if the test substance can be diluted or dispersed in water.
J_2/Data on viscosity are needed if the product is a liquid.
_^3/Data on miscibility are required if the product is an emulsifiable liquid and is to be diluted with petroleum
solvents.
-------
Table B
Product-Specific Data Requirements for Manufacturing-Use products and Formulation
Intermediates Containing Picloram
O
O
§158.
ACUTE
81-1
81-2
81-3
81-4
Data Requirement
340 Toxicology
TESTING
- Acute Oral Toxicity
- Rat
- Acute Dermal Toxicity
- Rabbit
- Acute Inhalation
Toxicity - Rat
- Primary Eye
irritation - Rabbit
Test Use
Substance^/ Pattern
MP A,B,G
K Salt
IOE
TEA
IPA
TIPA
MP A,B,G
K Salt
IOE
TEA
IPA
TIPA
MP A,B,G
K Salt
IOE
TEA
IPA
TIPA
MP A,B,G
K Salt
IOE
TEA
IPA
TIPA
Does EPA
Have Data?
Yes
Yes
NO
NO
NO
Yes
Yes
NO
No
NO
Yes
Yes
No
No
No
Yes
Yes
No
No
No
Must
Bibliographic
Citation Be
40479401
40479407
40479402
40479408
40479403
40479409
40479404
40479410
Additional
Data
Submitted
NO
No
Yes
Yes
Yes
NO
NO
Yes
Yes
Yes
NO
No
Yes
Yes
Yes
NO
NO
Yes
Yes
Yes
Time frame
for
Submission2/
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
-------
Table B
Product-Specific Data Requirements for Manufacturing-Use Products and Formulation
Intermediates Containing Picloram (Cont'd)
Test
Data Requirement
Use
Must Additional Timeframe
Does EPA Bibliographic Data for
Have Data? Citation Be Submitted Submission?/
S158.340 Toxicology
ACUTE TESTING (Cont'd)
81-5
81-6
- Primary Dermal
Irritation - Rabbit
- Dermal Sensitization -
Guinea Pig
MP A,B,G
K Salt
IOE
TEA
IPA
TIPA
MP A,B,G
K Salt
IOE
TEA
IPA
TIPA
Yes
Yes
NO
NO
NO
Yes
Yes
No
NO
No
40479405
40479411
40479406
40479412
NO
NO
Yes
Yes
Yes
No
No
Yes
Yes
Yes
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
I/Test Substance: Potassium salt of picloram = K Salt; Isooctyl ester of picloram = IOE; Triethylamine salt of
picloram = TEA; Isopropylamine salt of picloram = IPA; and Triisopropanolamine salt of picloram = TIPA.
2/Data must be submitted within the indicated timeframe, based on date of this Guidance Document.
-------
II. LABELING APPENDICES
102
-------
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 text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. [40 CFR 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 estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
[40 CFR 156.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. [40 CFR 156.10(g)]
103
-------
SUMMARY-2
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. [40 CFR 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. [40 CFR 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)]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR 162.56(h)(l)(lii)]
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)].
104
-------
SUMMARY-3
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR 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.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of Part 152, Subpart I. You will be notified
of the Agency's classification decision.
105
-------
SUMMARY-4
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement 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.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
106
-------
SUMMARY-5
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.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix II,
STOR, PEST/DIS, and CONT/DIS to determine the storage and
disposal instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment.
[40 CFR 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.
107
-------
SUMMARY-6
LABELING REQUIREMENTS Of THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gal Ion
statement
Front panel
precaut ionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal ward
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
|_ COMMENTS
«
If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
o
CO
-------
SIM1ARY-7
ITEM
7C
7D
O 7E
\O
8
— trx
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
bide/ back panel
precautionary
s tatements
.. i .
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
products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COWENTS
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
-------
SUMMARY-8
ITEM
SC
9A
9B
10A
10B
IOC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immed iately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Required statement is:
"It is a violation of Federal law
to use this product in a manner
inconsistent with its labeling."
Must be set apart and clearly distin-
guishable from from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
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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 para-
graph (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, state-
ments, designs, or graphic matter on the labeling) and expressed
in such terms as to render it likely to be read and understood
by the ordinary individual under customary conditions of purchase
and use.
(ii) All required label text must:
(A) Be set in 6-point or larger type;
(B) Appear on a clear contrasting background; and
(C) Not be obscured or crowded.
(3) Language to be used. All required label or labeling text
shall appear in the English language. However, the Agency may
require or the applicant may propose additional text in other
languages as is considered necessary to protect the public. When
additional text in another language is necessary, all labeling
requirements will be applied equally to both the English and
other-language versions of the labeling.
(4) Placement of Label—(i) General. The label shall appear
on or be securely attached to the immediate container of the
1 1 1
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per-ticide product. For purposes of this Section, and the mis-
branding provisions of the Act, "securely attached" shall mean
that a label can reasonably be expected to remain affixed during
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 con-
cerning the labeling, marking and placarding of hazardous materials
and the vehicles carrying them, define the basic Federal require-
ments. In addition, when any registered pesticide product is
transported in a tank car, tank truck or other mobile or portable
bulk container, a copy of the accepted label must be attached to
the shipping papers, and left with the consignee at the time of
delivery.
(B) Storage. When pesticide products are stored in bulk
containers, whether mobile or stationary, which remain in the
custody of the user, a copy of the label of labeling, including
all appropriate directions for use, shall be securely attached to
the container in the immediate vicinity of the discharge control
valve.
(5) False or misleading statements. Pursuant to section
2(q)(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 representations
in the labeling which constitute misbranding include:
(i) A false or misleading statement concerning the composition
of the product;
(ii) A false or misleading statement concerning the effectiveness
of the product as a pesticide or device;
(iii) A false or misleading statement about the value of the
product for 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;
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(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"
(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 S 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°F (20°C) and shall be
expressed in conventional American units'of fluid ounces, pints,
quarts, and gallons.
(3) If the pesticide is solid or semisolid, viscous or
pressurized, or is a mixture of liquid and solid, the net content
statement shall be in terms of weight expressed as avoirdupois
pounds and ounces.
(4) In all cases, net content shall be stated in terms of the
largest suitable units, i.e., "1 pound 10 ounces" rather than
"26 ounces."
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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 .Registration
No.," or the phrase "EPA Reg. No." The registration number shall
be set in type of a size and style similar to other print on that
part of the label on which it appears and shall run parallel to
it. The registration number and the required identifying phrase
shall not appear in such a manner as to suggest or imply
recommendation or endorsement of the product by the Agency.
(f) Producing establishments registration number. The producing
establishment registration number preceded by the phrase "EPA
Est.", of the final establishment at which the product was produced
may appear in any suitable location on the label or immediate
container. It must appear on the wrapper or outside container of
the package if the EPA establishment registration number on the
immediate container cannot be clearly read through such wrapper
or container.
(g) Ingredient statement—(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 pesticides which contain 100 percent
active ingredients. Unless the ingredient statement is a complete
analysis of the pesticide, the term "analysis" shall not be used
as a heading for the ingredient statement.
(2) Position of ingredient statement. (i) The ingredient
statement is normally required on the front panel of the label.
If there is an outside container or wrapper through which the
ingredient statement cannot be clearly read, the ingredient
statement must also appear on such outside container or wrapper.
If the size or form of the package makes it impracticable to place
the ingredient statement on the front panel of the label, permission
may be granted for the ingredient statement to appear elsewhere.
(ii) The text of the ingredient statement must run parallel
with other text on the panel on which it appears, and must be
clearly distinguishable from and must not be placed in the body
of other text.
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(3) Names to be used in ingredient statement. The name usec?
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 per-
centages 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 manu-
facturing batches, the value stated for each active ingredient
shall be the lowest percentage which may be present.
(6) Deterioration. Pesticides which change in chemical
composition significantly must meet the following labeling re-
quirements :
(i) In cases where it is determined that a pesticide formulation
changes chemical composition significantly, the product must bear
the following statement in a prominent position on 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:
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Hazard Indicators
Oral U>
Inhalation 1C
50
Dermal LD
Eye effects
Skin effects
1
Up to and
Including
50 «g/kg
Up to and
Including
.2 »g/l Iter
Up to and
Including
200 nig/kg
Corrosive;
cornea! opacity
not reversible
within 7 days
Corrosive
Toxicity c
II
From 50 thru
500 «g/kg
Fro* .2 thru
2 mg/l »ter
From 200
thru 2000
Cornea! opacity
reversible
within 7 days;
Irritation
persisting for
7 days
Severe Irritation
at 72 hours
ategorles
III
From 500 thru
5000 mg/kg
From 2 thru
20 ing/liter
From 2,000 thru
20,000
No cornea! opacity;
Irritation
reversible
• tthln 7 days
Mode-ate Irritation
at 72 hou-s
IV
Greater than
5000 ng/kg
Greater than
20 wg/l Iter
Greater than
20,000
No Irritation
Mild or slight
Irritation at
72 hours
(i) Human hazard signal word.—(A) Toxicity Category I.
pesticide products meeting the criteria of Toxicity Category
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
from skin and eye local effects) the
in red on a background of distinctly
skull and crossbones shall appear in
word "poison
All
I
dermal toxicity (as distinct
word "Poison" shall appear
contrasting color and the
immediate proximity to the
(B) Toxicity Category II. All pesticide products meeting the
criteria of Toxicity Category II shall bear on the front panel*
the signal word "Warning."
All pesticide products meeting the
III shall bear on the front panel
(C) Toxicity Category III.
criteria of Toxicity Category
the signal word "Caution."
(D) Toxicity Category IV.
criteria of Toxicity Category
the signal word "Caution."
All pesticide products meeting the
IV shall bear on the front panel
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(E) Use of signal words. Use of any signal word(s) associated
with a higher Toxicity Category is not permitted except when the
Agency determines that such labeling is necessary to prevent
unreasonable adverse effects on man or the environment. In no
case shall more than one human hazard signal word appear on the
front panel of a label.
(ii) Child hazard warning. Every pesticide product label shall
bear on the front panel the statement "keep out of reach of
children." Only in cases where the likelihood of contact with
children during distribution, marketing, storage or use is
demonstrated by the applicant to be extremely remote, or if the
nature of the pesticide is such that it is approved for use on
infants or small children, may the Administrator waive this
requirement.
(iii) Statement of practical treatment—(A) Toxicity
Category I. A statement of practical treatment (first aid or
other) shall appear on the front panel of the label of all
pesticides falling into Toxicity Category I on the basis of oral,
inhalation or 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 toxicity categories. The statement of practical
treatment is not required on the front panel except as described
in paragraph (h)(1)(ill)(A) of this section. The applicant may,
however, include such a front panel statement at his option.
Statements of practical treatment are, however, required elsewhere
on the label in accord with paragraph (h)(2) of this section if
they do not appear on the front panel.
(iv) Placement and prominence. All the required front panel
warning statements shall be grouped together on the label, and
shall appear with sufficient prominence relative to other front
panel text and graphic material to make them unlikely to be over-
looked under customary conditions of purchase and use. The
following table shows the minimum type size requirements for the
front panel warning statements on various sizes of labels:
Size of label front panel
in square inches
Above 10 to 15 ....
Above 15 to 30 .........
Poir
Required
signal word,
all capitals
6
10
12
14
18
its
"Keep out
of reach of
Children"
6
6
8
10
12
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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 "Precautionary
Statements" and under appropriate subheadings of "Hazard to Humans
and Domestic Animals," "Environmental Hazard" and "Physical or
Chemical Hazard."
(i) Hazard to humans and domestic animals. (A) Where a hazard
exists to humans or domestic animals, precautionary statements
are required indicating the particular hazard, the route(s) of
exposure and the precautions to be taken to avoid accident, injury
or damage. The precautionary paragraph shall be immediately
preceded by the appropriate hazard signal word.
(B) The following table depicts typical precautionary statements.
These statements must be modified or expanded to reflect specific
hazards.
ToxicIty
category
Precautionary statements by toxicIty category
Oral, Inhalation, or dermal toxlclty
Skin and eye local effects
I
II
III
IV
Fatal (poisonous) If snail owed (Inhaled or
absorbed through skin). Do not breathe
vapo1- (dust) or spray mist]. Do not get
In eyes, on skin, or on clothing (Front
panel statement of practical treatment
requ'red.l.
May be fatal If swallowed (Inhaled or
absorbed through the skin). Do not breathe
vapo-s (dust or spray Mist). Do not get In
eyes, on skin, or on clothing. (Appropriate
first aid statements required.I.
Harmful If swallowed I Inhaled or absorbed
through the skin). Avoid breathing vapors
(dust or spray nlst). Avoid contact with
skin (eyes or clothing). (Appropriate
first aid statement required.).
(No precautionary statements required.).
Corrosive, causes eye and skin damage (or
skin Irritation). Do not get In eyes, on
skin, or on clothing. Wear goggles or face
shield and rubber gloves when handling.
Harmful or fatal If swallowed.
(Appropriate first aid statement required.)
Causes eye land skin] Irritation. Do not
get In eyes, on skin, or on clothing.
Harmful If swallowed. (Appropriate first
aid statement required.!.
Avoid contact with skin, eyes or clothing.
In case of contact Immediately flush
eyes or skin with plenty of water. Get
medical attention If Irritation persists.
I No precautionary statements required.).
(ii) Environmental hazards. Where a hazard exists to non-
target, organisms excluding humans and domestic animals, precautionary
statements are required stating the nature of the hazard and the
appropriate precautions to avoid potential accident, injury or
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damage. Examples of the hazard statements and the circumstances
under which they are required follow:
(A) If a pesticide intended for outdoor use contains an active
ingredient with a mammalian acute oral LD5Q of 100 or less, the
statement "This Pesticide is Toxic to Wildlife" is required.
(B) If a pesticide intended for outdoor use contains an active
ingredient with a fish acute LC$Q of 1 ppm or less, the statement
"This Pesticide is Toxic to Fish" is required.
(C) If a pesticide intended for outdoor use contains an active
ingredient with an avian acute oral LD$Q of 100 mg/kg or less, or
a subacute dietary LC$Q 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:
Flash point
Required text
(A) PRESSURIZED CONTAINERS
Flash point at or below 20*F; If there Is a
flashback at any valve opening.
Flash point above 20*F and not over 80*F or If
the flame extension Is (tore than 18 In. long
at a distance of 6 In. from the flame.
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 open flame. Do not
puncture or Incinerate container. Exposure to
temperatures above UO'F may cause bursting.
Contents under pressure. Do not use or store
near heat or open flame. Do not punctur* or
Incinerate container. Exposure to tempera-
tures above 130*F may cause bursting.
(8) NONPRESSURI2ED CONTAINERS
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 or open flame.
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(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 direction for use—(A)
Detailed directions for use may be omitted from labeling of
pesticides which are intended for use only by manufacturers of
products other than pesticide products in their regular manu-
facturing processes, provided that:
(_!) The label clearly shows that the product is intended for
use only in manufacturing processes and specifies the type(s) of
products involved.
(j2) 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;
(2) 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
(_3) The product is also a drug and regulated under the provisions
of The Federal Food, Drug and Cosmetic Act.
(C) Detailed directions for use may be omitted from the labeling
of pesticide products which are intended for use only by formulators
in preparing pesticides for sale to the public, provided that:
U) There is information readily available to the formulators
on the composition, toxicity, methods of use, applicable restrictions
or limitations, and effectiveness of the product for pesticide
purposes ;
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(^) The label clearly states that the product 's intended for
use only in manufacturing, formulating, mixing, or repacking for
use as a pesticide and specifies the type(s) of pesticide products
involved;
O) The product as finally manufactured, formulated, mixed, or
repackaged is registered; and
(£) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(2) Contents of Directions for Use. The directions for use
shall include the following, under the headings "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 requried.
(vii) The frequency and timing of applications necessary to
obtain effective results without causing unreasonable adverse
effects on the environment.
(viii) Specific limitations on reentry to areas where the
pesticide has been applied, meeting the requirements concerning
reentry provided by 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 S 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
may only be applied under the direct supervision of a certified
applicator who is physically present.
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(F) Other pertinent information which the Administrator
determines to be necessary for the protection of man and the
environment.
(j) Statement of Use Classification. By October 22, 1976, all
pesticide products must bear on their labels a statement of use
classification as described in paragraphs (j)(l) and (2) of this
section. Any pesticide product for which some uses are classified
for general use and others for restricted use shall be separately
labeled according to the labeling standards set forth in this
subsection, and shall be marketed as separate products with
different registration numbers, one bearing directions only for
general use(s) and the other bearing directions for restricted
use(s) except that, if a product has both restricted use{s) and
general use(s), both of these uses may appear on a product labeled
for restricted use. Such products shall be subject to the
provisions of § 162.10(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 misleading
statement under the statutory definitions of misbranding.
(2) Restricted Use Classification. Pesticide products bearing
direction for use(s) classified restricted shall bear statements
of restricted use classification on the front panel as described
below:
(i) Front panel statement of restricted use classification.
(A) At the top of the front panel of the label, set in type of
the same minimum sizes as required for human hazard signal words
(see table in S 162.10(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: "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." If, however, other
regulatory restrictions are imposed, the Administrator will define
the appropriate wording for the terms of restriction by regulation,
(k) Advertising. [Reserved]
[40 FR 28268, July 3, 1975; 40 FR 32
38571, Aug. 21, 1975, as amended at
amended at 53 FR 15952, May 4, 19881
32329, Aug. 1, 1975; 40 FR
43 FR 5786, Feb. 9, 1978;
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Criteria
PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Required Label Statement
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. All Other Pressurized
Containers
II. Non-Pressurized Containers
A. 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.
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 incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
123
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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.
124
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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."
2. Except those products intended solely for domestic use, the labels
of all products that contain active ingredients that are Acute Hazardous
Wastes or are assigned to Toxicity Category I on the basis of oral or
dermal toxicity, or Toxicity Category I or II on the basis of acute
inhalation toxicity must bear the following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal of
excess pesticide, spray mixture, or rinsate is a violation of Federal
Law. If these wastes cannot be disposed of by use according to
label instructions, contact your State Pesticide or Environmental
Control Agency, or the Hazardous Waste representative at the nearest
EPA Regional Office for guidance."
3. The labels of all products, except those intended for domestic use,
containing active or inert ingredients that are Toxic Hazardous Wastes
or meet any of the criteria in 40 CFR 261, Subpart C for a hazardous
waste must bear the following pesticide disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess pesticide,
spray mixture, or rinsate is a violation of Federal Law. If these
wastes cannot be disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control Agency, or the
Hazardous Waste representative at the nearest EPA Regional Office
for guidance."
4. Labels for all other products, except those intended for domestic
use, must bear the following pesticide disposal statement:
"Wastes resulting from the use of this product may be disposed of on
site or at an approved waste disposal facility."
5. Products intended for domestic use only must bear the following
disposal statement: "Securely wrap original container in several layers
of newspaper and discard in trash."
125
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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 Type Statement
Non-aerosol products
(bottles, cans, jars)
Non-aerosol products
(bags)
Aerosol products
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding 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:
Container Type
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,
stay 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 wording)
J_/ Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
126
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III. BIBLIOGRAPHY APPENDICES
127
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BIBGUIDE-1
GUIDE TO USE OF THIS BIBLIOGRAPHY
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
128
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BIBGUIDE-2
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission.
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th. 123456-Z; and the 27th, 123456-AA.
129
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Picloram Standard
MRID CITATION
00022923 Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary
Toxicities of Environmental Pollutants to Birds: Special Scien-
tific Report—Wildlife No. 191. (U.S. Dept. of the Interior,
Fish and Wildlife Service, Patuxent Wildlife Research Center;
unpublished report)
00023105 Fisher, D.E.; St. John, L.E., Jr.; Guntenman, W.E.; et al. (1965)
Fate of Banvel T, loxynil, Tordon and Trifluorilin in the dairy
cow. Journal of Dairy Science 48(12):1711-1715. (Also in un-
published submission received Apr 8, 1976 under 876-203; submit-
ted by Velsicol Chemical Corp., Chicago, 111.; CDL:235226-Y)
00026748 Leahy, J.S.; Taylor, T. (1966) Residues of Tordon in Treated Grain.
Undated method 1556/66/85. (Unpublished study received Nov 21,
1967 under 8F0660; prepared by Huntingdon Research Centre, sub-
mitted by Dow Chemical U.S.A., Midland, Mich.; CDL:091151-I)
00026749 Dow Chemical Company (19??) Analytical Methods for Residues in
Grain and Straw. Summary of studies 091151-1 and 091151-K
through 091151-O. (Unpublished study received Nov 21, 1967 un-
der 8F0660; CDL:09151-J)
00026750 Dow Chemical Company (1966) Determination of Residues of Tordon
Acid in Wheat Grain by Gas Chromatography. Method ACR 65.3R
dated Feb 4, 1966. (Unpublished study received Nov 21, 1967
under 8F0660; CDL:091151-K)
00026751 Dow Chemical Company (1965) Gas Chromatographic Method for the De-
termination of Residues of Tordon Acid in Wheat Straw. Method
ACR 65.4R dated Nov 15, 1965. (Unpublished study received Nov
21, 1967 under 8F0660; CDL:091151-L)
00026752 Dow Chemical Company (1966) Determination of Residues of Tordon
Acid in Wheat Straw by Gas Chromatography. Method ACR 66.5
dated May 6, 1966. (Unpublished study received Nov 21, 1967
under 8F0660; CDL:091151-M)
00026753 Leahy, J.S.; Taylor, T. (1967) A gas-chromatographic determination
of residues in Picloram. Analyst 92(?/Jun):371-374. (Also in
unpublished submission received Nov 21, 1967 under 8F0660; sub-
mitted by Dow Chemical U.S.A., Midland, Mich.; CDL:091151-0)
00027288 Dow Chemical Company (1967) Determination of Residues of Tordon
Acid in Barley Straw by Gas Chromatography. Method ACR 67.4
dated Jul 7, 1967. (Unpublished study received Nov 21, 1967
under 8F0660; CDL:091151-N)
130
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Picloram Standard
MRID CITATION
00035959 Riley, V.; Kutschinski, A.H. (1967) Residues of Tordon acid in Eggs
and Tissues from Chickens Fed the Herbicide. (Unpublished study
received Jul 3, 1975 under 6F1653; submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL:094501-E)
00036168 Bjerke, E.L.; Ervick, O.K.; Stymiest, C.; et al. (1973) A Residue
Study of the Disappearance of Picloram and 2,4-Dichlorophenoxy-
acetic acid in Small Grain following Application of Tordon Her-
bicide: GH-C 683. (Unpublished study received Jul 3, 1975 under
6F1653; prepared in cooperation with South Dakota State Univ.
and others, submitted by Dow Chemical Co., Indianapolis, Ind.;
CDL:094498-C)
00036170 Southwick, L.; Behrens, R.; Hartman, G.P. (1975) A Residue Study
of Picloram and 2,4-Dichlorophenoxyacetic acid in Wheat follow-
ing One, Two and Three Years Use of Picloram and 2,4-D (Tor-
don: 202 Mixture): GHP-913. (Unpublished study received
Jul 3, 1975 under 6F1653; prepared in cooperation with Univ. of
Minnesota and Univ. of Montana, submitted by Dow Chemical Co.,
Indianapolis, Ind.; CDL:094498-E)
00036171 Bjerke, E.L.; Dietrich, I.; Baker, L.O.; et al. (1975) A Residue
Study of Picloram and 2,4-D in Wheat and Barley following Post-
emergence Application of Tordon 22K Weed Killer plus Formula 40
Herbicide: GH-C 821. (Unpublished study received Jul 3, 1975
under 6F1653; prepared in cooperation with Univ. of Montana and
Montana State Univ., submitted by Dow Chemical Co., Indianapo-
lis, Ind.; CDL:094498-F)
00036935 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1975) Toxicity of
Pesticides and Other Agricultural Chemicals to Honey Bees:
Laboratory Studies. By University of California, Dept of
Entomology. ?; UC, Cooperative Extension (leaflet 228;
published study).
00037880 Meikle, R.W.; Williams, E.A.; Redemann, C.T. (1966) Metabolism of
Tordon herbicide (4-Amino-3,5,6-trichloropicolinic acid) in cot-
ton and decomposition in soil. Journal of Agricultural and Food
Chemistry 14(4):384-387. (Also in unpublished submission re-
ceived Jun 6, 1973 under 2F1265; submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL:092164-N)
00041125 Dow Chemical Company (1964) A Residue Study on Tissues from Beef
Cattle Fed Diets Containing Tordon Herbicide. (Unpublished
study received Nov 6, 1967 under OF0863; CDL:094525-AJ)
131
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Picloram Standard
MRID CITATION
00041136 Bauriedel, W.R.; Neipert, N. (1965) The Fate of Labeled 14C-Triiso-
propanol amine Applied to Spring Wheat, (Unpublished study re-
ceived Nov 6, 1967 under OF0863; submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL:094525-AX)
00041475 Alexander, B.C.; Batchelder, T.L. (1965) Results of a Study on the
Acute Toxicity of Tordon: Herbicide to Three Species of
Fish. (Unpublished study received Nov 6, 1967 under OF0863;
submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:094524-H)
00045363 Swann, R.L.; Pettyjohn, M.A.; Bjerke, E.L. (1972) Determination of
Residues of Picloram in Wheat, Barley and Oat Green Forage,
Grain and Straw by Gas Chromatography. Method ACR 72.7 dated
May 12, 1972. (Unpublished study received Jul 3, 1975 under
6F1653; prepared in cooperation with International Research and
Development Corp., submitted by Dow Chemical U.S.A., Midland,
Mich.; CDL:094500-A)
00045369 Bjerke, E.L.; Ervick, O.K. (1975) A Residue Study of Picloram and
2,4-D in Milled Wheat Fractions: GH-C 798. (Unpublished study
received Jul 3, 1975 under 6F1653; submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL:094501-B)
00045373 Dow Chemical U.S.A. (1967) Determination of Residues of Tordon acid
in Milk by Gas Chromatography. Method ACR 67.3 dated Jun 22,
1967. (Unpublished study received Jul 3, 1975 under 6F1653;
CDL:094501-G)
00045374 Kutschinski, A.H.; Riley, V. (1967) Residues of Tordon acid in Tis-
sues from Steers Fed the Herbicide. (Unpublished study received
Jul 3, 1975 under 6F1653; submitted by Dow Chemical U.S.A., Mid-
land, Mich.; CDL:094501-H)
00045375 Dow Chemical U.S.A. (1967) Determination of Residues of Tordon acid
in Bovine Tissues by Gas Chromatography. Method ACR 67.2 dated
Jun 21, 1967. (Unpublished study received Jul 3, 1975 under
6F1653; CDL:094501-I)
00045376 Bjerke, E.L.; Riley, V.; Bucek, O.C.; et al. (1969) Residues of
Picloram in Sheep Tissues. (Unpublished study received Jul 3,
1975 under 6F1653; submitted by Dow Chemical U.S.A., Midland,
Mich.; CDL:094501-J)
00045409 Dow Chemical Company (1966) Determination of Residues of Tordon
acid in Grass by Gas Chromatography. Analytical method ACR 66.7
dated Jul 11, 1966. (Unpublished study received Aug 4, 1969 un-
der OF0863; CDL:093160-G)
132
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Picloram Standard
MRID CITATION
00059411 Redemann, C.T.; Meikle, R.W.; Hamilton, P.; et al. (1968) The fate
of 4-Amino-3,5,6-trichloropicolinic acid in spring wheat and
soil. Bulletin of Environmental Contamination & Toxicology 3
(2):80-96. (Also in unpublished submission received Sep 26,
1974 under 464-323; submitted by Dow Chemical U.S.A., Midland,
Mich.; CDL:120353-B)
00062817 Jeffries, T.K. (1980) Residues of 3,6-Dichloropicolinic acid and
Picloram in Grass Treated in Texas. Method GH-C 1309 dated Apr
29, 1980. (Unpublished study received Nov 28, 1980 under 464-
EX-67; submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:
099796-P)
00062818 Jeffries, T.K. (1980) Determination of Residues of 3,6-Dichloro-
picolinic acid and Picloram in Grass by Electron Capture Gas
Chromatography. Method ACR 80.8 dated Jul 24, 1980. (Unpub-
lished study received Nov 28, 1980 under 464-EX-67; submitted by
Dow Chemical U.S.A., Midland, Mich.; CDL:099796-Q)
00078483 Dow Chemical Company (1967) Residue Determination Method: Determi-
nation of Residues of Tordon: Acid in Chicken Eggs and Tis-
sues by Gas Chromatography. Method ACR 67.5 dated Sep 14, 1967.
(Unpublished study received on unknown date under 4E1489; sub-
mitted by Montana, Dept. of Agriculture, Helena, Mont.; CDL:
093949-B)
00085060 Interregional Research Project Number 4 (1981) Summary of Residue
Chemistry Data: [Picloram]. (Compilation; unpublished study
received Oct 20, 1981 under 2E2585; CDL:070422-A)
00098321 Nolan, R.J.; Smith, F.A.; Muller, C.J.; et al. (1980) Kinetics of
14C-labeled Picloram in Male Fischer 344 Rats. (Unpublished
study received Apr 6, 1982 under 464-320; submitted by Dow Chem-
ical U.S.A., Midland, Mich.; CDL:247156-H)
00098322 Mensik, D.C.; Johnston, R.V.; Pinkerton, M.N.; et al. (1976) The
Cytogenetic Effects of Picloram on the Bone Marrow Cells of
Rats. (Unpublished study received Apr 6, 1982 under 464-320;
prepared in cooperation with Univ. of Texas, Medical Branch,
submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:247156-I)
00108862 Dow Chemical Co. (1970) Residues of Picloram in Grass. (Compi-
lation; unpublished study received Apr 5, 1970 under OF0863;
CDL:091493-A)
133
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Picloram Standard
MRID CITATION
00108864 Dow Chemical Co. (1969) The Results of Tests on the Amount of
Residue Remaining Including a Description of Analytical Methods
Used (Tordon). (Compilation; unpublished study received Apr 5,
1970 under OF0863; CDL:091494-B)
00110534 Barna-Lloyd, T.; Taylor, H.; Swaim, L.; et al. (1982) Results of a
Six-month Dietary Toxicity Study of Picloram ..., Administered
in the Diet to Male and Female Beagle Dogs: Study TXT:K-038323-
(28). Final rept. (Unpublished study received Aug 23, 1982
under 464-502; submitted by Dow Chemical U.S.A., Midland, MI;
CDL:248162-A)
00110537 Gorzinski, S.; Johnson, K.; Campbell, R.; et al. (1982) Technical
Grade Picloram: Results of a 13-week Dietary Toxicity Study in
Fischer 344 Rats: Laboratory Report Code HET K-038323-(32).
Final rept. (Unpublished study received Aug 23, 1982 under 464-
502; submitted by Dow Chemical U.S.A., Midland, MI; CDL:
248162-D)
00111404 Dow Chemical U.S.A. (1974) Residues: [Tordon 22K]. (Compilation;
unpublished study received Sep 26, 1974 under 464-323; CDL:
009845-A)
00111407 Dow Chemical Co. (1967) The Results of Tests on the Amount of Res-
idue Remaining, Including a Description of the Analytical Method
used: [Tordon]. (Compilation; unpublished study received Nov
21, 1967 under 8F0660; CDL:090777-A)
00111482 Ervick, D.; Getzendaner, M. (1974) Residues of Picloram in Grass
Treated with Tordon 10K Pellets: GH-C 760. (Unpublished study
received Oct 10, 1974 under 464-320; submitted by Dow Chemical
U.S.A., Midland, MI; CDL-.120321-B)
00111527 Maroder, H.; Prego, I. (1971) Transformation of picloram in
prosopis ruscifolia and diplotaxis tenuifolia. Weed Res. 11:193
195. (Also in unpublished submission received Sep 26, 1974
under 464-323; submitted by Dow Chemical U.S.A., Midland, MI;
CDL:120317-T)
00111556 Dow Chemical U.S.A. (1975) Chemical Study: Tordon K Salt Liquor
(Compilation, unpublished study received Sep 10, 1976 under
464-541; CDL: 226132A)
00111557 Bjerke, E. (1975) A Residue Study of Picloram in Grass following
Application of M-3864 Herbicide: GH-C 805. (Unpublished study
received Sep 10, 1976 under 464-541; submitted by Dow Chemical
U.S.A., Midland, MI; CDL:226133-A)
134
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Picloram Standard
MRID CITATION
00111560 Heitmuller, T. (1975) Acute Toxicity of Tordon 10K Pellets to Lar-
vae of the Eastern Oyster ..., Pink Shrimp ..., and Fiddler
Crabs (Uca-pugilater). (Unpublished study received Sep 10, 1976
under 464-541; prepared by Bionomics—EG & G, Inc., submitted by
Dow Chemical U.S.A., Midland, MI; CDL:226137-D)
00128714 Dow Chemical U.S.A. (1983) Residue Chemistry: [Tordon K Salt Liq-
uor: Grains and Animal Tissue]. (Compilation; unpublished study
received Jun 20, 1983 under 464-502; CDL:250508-A; 250509)
00128947 Bidlack, H. (1980) Determination of the Bioconcentration Factor for
Picloram in Bluegill Sunfish during Continuous Aqueous Exposure:
GH-C 1384. (Unpublished study received Jun 16, 1983 under
464-502; submitted by Dow Chemical U.S.A., Midland, MI; CDL:
250517-A)
00128976 McCall, P.; Jeffries, T. (1978) Aerobic and Anaerobic Soil Degrada-
tion of 14C-picloram. Final rept. (Unpublished study received
Jun 16, 1983 under 464-502; submitted by Dow Chemical U.S.A.,
Midland, MI; CDL:250518-A)
00129073 Heitmuller, T. (1975) Acute Toxicity of Tordon 22K to Larvae of the
Eastern Oyster (Crassostrea virginica), Pink Shrimp (Penaeus du-
orarum), and Fiddler Crabs (Uca pugilator). (Unpublished study
received Jun 24, 1983 under 464-502; prepared by Bionomics—
EG & G, Inc., submitted by Dow Chemical U.S.A., Midland, MI;
CDL:250605-L)
00129076 Mayes, M.; Dill, D. (1982) The Toxicity of Picloram ... to Repre-
sentative Freshwater Organisms: ES-561. (Unpublished study re-
ceived Jun 24, 1983 under 464-502; submitted by Dow Chemical
U.S.A., Midland, MI; CDL:250605-0)
00129078 McCarty, W.; Alexander, H.; Park, C. (1977) Comparative Toxicity
of Three Samples of Technical Picloram Containing Various
Amounts of N1'-(3,4,5,6-Tetrachloro-2-pyridinyl) Guanidine to
Bluegill. (Unpublished study received Jun 24, 1983 under 464-
502; submitted by Dow Chemical U.S.A., Midland, MI; CDL.-250605-Q)
00129085 Woodward, D. (1979) Assessing the hazard of picloram to cutthroat
trout. Journal of Range Management 32(3):230-232. (Also in un-
published submission received Jun 24, 1983 under 464-502; sub-
mitted by Dow Chemical U.S.A., Midland, MI; CDL:250605-Y)
00131364 Dow Chemical U.S.A. (1983) Residue Chemistry: [Tordon K Salt Liq-
our]. (Compilation; unpublished study received Aug 9, 1983 un-
der 464-502; CDL:251037-A)
135
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Picloram Standard
MRID CITATION
00131365 Hamaker, J. (1976) The Hydrolysis of Picloram in Buffered Distilled
Water: GS-1460. (Unpublished study received Aug 9, 1983 under
464-502; submitted by Dow Chemical U.S.A., Midland, MI; CDL:
251038-A)
00132986 Dow Chemical U.S.A. (1980) Results of Tests on the Amount of Resi-
due Remaining, Including a Description of the Analytical Methods
Used: [3,6-Dichloropicolinic Acid on Forage Grasses]. (Compila-
tion; unpublished study received Dec 7, 1983 under 464-EX-81;
CDL:251919-C)
00141979 Mccarty, W. (1977) Toxicity of 4-Amino-3,5,6-trichloropicolinic
Acid, Picloram, to Daphnids: Final Report. Unpublished study
prepared by Dow Chemical U.S.A. 8 p.
00151783 Gersich, F.; Hopkins, D.; Milazzo, D. (1984) The Acute and Chronic
Toxicity of Technical Picloram (4-Amino-3,5,6-trichloropicolinic
acid) to Daphnia magna Straus: ES-690. Unpublished study pre-
pared by Dow Chemical USA. 16 p.
00151784 Mayes, M.; Dill. D.; Hopkins, D. (1984) The Toxicity of Technical
Picloram to the Embryo, Larval, and Juvenile Stages of the
Rainbow Trout (Salmo gairdneri Richardson): ES-703. Unpublished
study prepared by Dow Chemical USA. 17 p.
00154235 Dow Chemical USA. (1985) Technical Information in Support of the
Registration of Tordon K Salt Liquor. Unpublished study. 95 p.
00155940 Landry, T.; Johnson, K.; Cieszlak, F.; et al. (1986) Picloram: A
Two-year Dietary Chronic Toxicity-oncogenicity Study in Fischer
344 Rats. Unpublished study prepared by Dow Chemical U.S.A.
1243 p.
00156366 Dow Chemical USA (1986) Results of Tests on the Amount of Residues
Remaining Including a Description of the Analytical Method :of
Picloram on Grasses:. Unpublished compilation. 300 p.
00157171 Bauriedel, W.; Miller, J. (1986) Metabolic Fate of :Carbon-14:-
picloram Applied to Wheat: GH-C 1787. Unpublished study prepar-
ed by Dow Chemical USA. 15 p.
00157173 Beavers, J. (1983) An Acute Oral Toxicity Study in the Mallard with
Picloram Technical: Final Report: Project No. 103-221. Unpub-
lished study prepared by Wildlife International Ltd. 15 p.
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 Picloram Standard
MRID CITATION
00157174 Beavers, J. (1985) Picloram Potassium Salt: An Acute Oral Toxicity
Study with the Mallard: Final Report: Project No. 103-245. Un-
published study prepared by Wildlife International Ltd. 17 p.
00161306 Yackovich, P.; Miller, J. (1986) The Fate of :Carbon 14: Labeled
Picloram Fed to Laying Hens :with Metabolism Study as Appendix:.
Unpublished study prepared by Dow Chemical U.S.A. 64 P.
00163216 Yackovich, P.; Miller, J. (1986) The Fate of :Carbon 14: Labeled
Picloram Fed to Lactating Goats. Unpublished study prepared by
Dow Chemical USA in cooperation with Analytical Bio-Chemistry
Laboratories, Inc. 73 p.
00164725 Bjerke, E.; Majorski, S. (1986) Stability of Picloram in Grain,
Straw, Green Forage and Grass Samples Stored Frozen: GH-C 1818.
Unpublished study prepared by Dow Chemical U.S.A. 9 p.
00164726 Grimes, J. (1986) Picloram Isooctyl Ester: A Dietary LC50 Study
with the Bobwhite: Final Report: WIL Project No. 103-249. Un-
published study prepared by Wildlife International Ltd. 17 p.
00164727 Beavers, J. (1986) Picloram Potassium Salt: A Dietary LC50 Study
with the Bobwhite: Final Report: WIL Project No. 103-244. Un-
published study prepared by Wildlife International Ltd. 17 p.
00164749 Woodburn, K. (1986) The Hydrolysis of Picloram Isooctyl Ester in
Buffered, Distilled Water: GH-C 1798. Unpublished study pre-
pared by Dow Chemical U.S.A. 22 p.
40082701 Bjerke, E. (1987) Stability of Picloram in Grain Straw, Green
Forage and Grass Samples Stored Frozen: GH-C 1818: Addendum—
15 Month Data. Unpublished study prepared by Dow Chemical
U.S.A. 3 p.
40094602 Johnson, W.; Finley, M. (1980) Handbook of Acute Toxicity of
Chemicals to Fish and Aquatic Invertebrates: Resource Publi-
cation 137. US Fish and Wildlife Service, Washington, D.C.
106 p.
40178601 Laskowski, D. (1987) Aerobic Soil Degradation of Picloram Isooctyl
Ester: Laboratory Project ID: GH-C 1901. Unpublished study pre-
pared by Dow Chemical U.S.A. 49 p.
40435601 Bjerke, E.; Majorski, S. (1987) Stability of Picloram in Grain,
Straw, Green Forage and Grass Samples Stored Frozen: Addendum—
24 Month Data: Laboratory Project ID GH-C 1818. Unpublished
study prepared by Dow Chemical U.S.A. 3 p.
137
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Picloram Standard
MRID CITATION
40479401 Jeffrey, M.; Battjes, J.; Yano, B. (1987) Tordon K Salt Liquor:
Acute Oral Toxicity Study in Fischer 344 Rats: Final Report: K-
050731-004A. Unpublished study prepared by The Dow Chemical Co.
Mammalian and Environmental Toxicology Research Laboratory. 26 p.
40479402 Jeffrey, M.; Phillips, J.; Lomax, L. (1987) Tordon K Salt Liquor:
Acute Dermal Toxicity Study in New Zealand White Rabbits: Final
Rept.: K-050731-004D. Unpublished study prepared by The Dow
Chemical Co., Mammalian and Environmental Toxicology Research
Laboratory. 18 p.
40479403 Streeter, C.; Battjes, J.; Yano, B. (1987) Tordon K Salt Liquor: An
Acute Aerosol Inhalation Study in Fischer 344 Rats: Final Rept.:
K-050731-005. Unpublished study prepared by The Dow Chemical Co.,
Mammalian and Environmental Toxicology Research Laboratory. 20 p.
40479404 Jeffrey, M. (1987) Tordon K Salt Liquor: Primary Eye Irritation
Study in New Zealand White Rabbits: Final Rept.: K-050731-004C.
Unpublished study prepared by The Dow Chemical Co., Mammalian
and Environmental Toxicology Research Laboratory. 12 p.
40497405 Hossack, D.; Gardner, J.; Baker, M. (1987) Acute Pulmonary Toxicity
and Infectivity to Rats of SAN 418-SC-62: Laboratory Project ID
871773D/SNC 14/AC. Unpublished study performed by Huntingdon
Research Laboratories Ltd*, England. 32 p,
40479406 Jeffrey, M. (1987) Tordon K Salt Liquor: Dermal Sensitization Po-
tential in the Hartley Albino Guinea Pig: K-05Q~>'3I-004E. Un-
published study prepared by The Dow Chemical Co., Mammalian and
Environmental Toxicology Research Laboratory. 13 p.
40479407 Jeffrey, M.; Schuetz, D.; Eisenbrandt, D. (1987) Picloram Isooctyl
Ester: Acute Oral Toxicity Study in Fischer 344 Rats: Study No.
K-041284-005A. Unpublished study prepared by The Dow Chemical Co.,
Mammalian and Environmental Toxicology Research Laboratory. 22 p.
40479408 Jeffrey, M.; Schuetz, D.; Yano, B. (1987) Picloram Isooctyl Ester:
Acute Dermal Toxicity Study in New Zealand White Rabbits: Study
ID K-041284-005D. Unpublished study prepared by The Dow Chemi-
cal Co., Mammalian and Environmental Toxicology Research Labora-
tory- 18 p.
40479409 Streeter, C.; Battjes, J.; Johnson, K. (1987) Picloram Isooctyl Es-
ter: An Acute Aerosol Inhalation Study in Fischer 344 Rats:
K-041284-006. Unpublished study prepared by The Dow Chemical
Co., Mammalian and Environmental Toxicology Research Laboratory.
21 p.
13:
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Picloram Standard
MRID CITATION
40479410 Jeffrey, M. (1987) Picloram Isoctyl Ester: Primary Eye Irritation
Study in New Zealand White Rabbits: K-041284-005C. Unpublished
study prepared by The Dow Chemical Co., Mammalian and Environ-
mental Toxicology Research Laboratory. 11 p.
40479411 Jeffrey, M. (1987) Picloram Isooctyl Ester: Primary Dermal Irrita-
tion Study in New Zealand White Rabbits: Final Rept.: K-041284-
005B. Unpublished study prepared by The Dow Chemical Co., Ma-
mmalian and Environmental Toxicology Research Laboratory. 12 p.
40479412 Jeffrey, M. (1987) Picloram Isooctyl Ester: Dermal Sensitization
Potential in the Hartley Albino Guinea Pig: Final Report: K-
041284-005E. Unpublished study prepared by The Dow Chemical
Co., Mammalian and Environmental Toxicology Research Laboratory.
14 p.
40479413 Jeffrey, M. (1987) Picloram Acid (Picloram Technical): Acute Oral
Toxicity Study in Fischer 344 Rats: Final Rept.: K-038323-042A.
Unpublished study prepared by The Dow Chemical Co., Mammalian
and Environmental Toxicology Research Laboratory. 26 p.
40479414 Jeffrey, M.; Schuetz, D.; Jersey, G. (1987) Picloram Acid (Picloram
Technical): Acute Dermal Toxicity Study in New Zealand White
Rabbits: Final Rept.: K-038323-041D. Unpublished study prepared
By The Dow Chemical Co., Mammalian and Environmental Toxicology
Research Laboratory. 17 p.
40479415 Streeter, C.; Battjes, J.; Johnson, K. (1987) Picloram Acid: An
Acute Aerosol Inhalation Study in Fischer 344 Rats: Final Rept.:
K-038323-043. Unpublished study prepared by The Dow Chemical
Co., Mammalian and Environmental Toxicology Research Laboratory.
21 p.
40479416 Jeffrey, M. (1987) Picloram Acid (Picloram Technical): Primary Eye
Irritation Study in New Zealand White Rabbits: Final Report: K-
038323-042C. Unpublished study prepared by The Dow Chemical
Co., Mammalian and Environmental Toxicology Research Laboratory.
11 p.
40479417 Jeffrey, M. (1987) Picloram Acid (Picloram Technical): Primary Der-
mal Irritation Study in New Zealand White Rabbits: Final Report:
K-038323-042B. Unpublished study prepared by The Dow Chemical
Co., Mammalian and Environmental Toxicology Research Laboratory.
10 p.
139
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Picloram Standard
MRID CITATION
40479418 Jeffrey, M. (1987) Picloram Acid (Picloram Technical): Dermal Sen-
sitization Potential in the Hartley Albino Guinea Pig: Final Re-
port: K-038323-042E. Unpublished study prepared by The Dow
Chemical Co., Mammalian and Environmental Toxicology Research
Laboratory. 13 p.
40588501 Baker, R. (1988) Product Chemistry Data ...: Tordon K Salt Liquor.
Unpublished study prepared by Agricultural Chemistry Research
and Development Laboratories, Dow Chemical U. S. A. 32 p.
140
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IV. FORM APPENDICES
141
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EPA Form 8580-1
OMB Approval No. 2070-0057
Expires 11/30/89
FIFKA SECTI6N 3ICH2KB) SUMMARY SHEET
E'A RiGlSTHATiON NO
PRODUCT NAME
APPLICANT'S NAME
DATE GUIDANCE DOCUMENT ISSUED
With ruatct to ttit rtquirtmtnt to submit "itntric" data impost* by tht FIFRA stction 3(C)(2)(B) notici eontamtd in the rtlcrtncid
Guidanct Oocumtnt. I am ctsponding m tht following mtnntr:
D1. I will mibmit dm in i wnrty minntr to »t*fy tht following rtquiramtntt If tht tnt jrottdurti I wiH u* dtv.tii from (or trt not
tpocifiod in) tht Rtootration Guidtlmn or tht Protocol! conttintd m Hit Rtpora of Eiptn Groupt to tht Chimiculs Group OECO
Chwnictli TtRm( rVoonmmt, I tnclott tht protocoll thn I will u*:
D i I htvt onnrtd mto M torNmtnt with ont or mort othtr rt««nnti undtr FIFRA onion )(C)(2)(l)(ii) to mitfy tht following dau
nqgirtmtnts. Tht tttts, and tny rtquirtd protocols, will bt wbmintd to E'A by:
NAME OF OTHE* REGISTRANT
D J. I tncloM i compllttd "Cartifieition of Antmpt to Entir Into in Ag'ttmtnt with Othtr fltfinrinu lor Otv»i<«» • r>*i»" with
ruptct to tht following dia rtquirtmtnti:
C 4. I nqum tnat you amtnd my rtgamtion by dtitting tnt following ami (thu option • not tvaiiioii to acpliunu lor ntw products):
D S. I rtqutn voluntary einctllttion of thi rtginntion pi thit product (This option ii not avtuablt to applicant! for ntw product!.)
REGISTRANTS AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
142
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OVB Approval No. 2070-0057
Expiration Date 11/30/89
GENERIC DATA EKEMPTIdXT STATEMENT
EFA Product Registration Number:.
Registrant's Name and Address:
As an authorized representative of the registrant of the product identified above, I
certify that:
(1) I have read and am familiar with the terms of the Notice from EPA. dated
concerning a requirement for submission of "generic" data on the active
ingredient named under FIFRA Section 3(c)(2)(B).
(2) My firm requests that EPA not suspend the registration of our product, despite
our lack of intent to submit the generic data in question, on the grounds that the
product contains the active ingredient solely as the result of the incorporation into
the product of another product which contains that active ingredient, which is
registered under FIFRA Section 3, and which is purchased by us from another producer.
(3) An accurate Confidential Statement of Formula (CSF) for the above-identified
product is attached to this statement. That formula statement indicates, by company
name, registration number, and product name, the source of the subject active
ingredient in my firm's product, or
The CSF dated on file with EFA is complete, current and accurate and
contains the information requested on the current CSF Form 8570-4. The registered
source(s) of the above named active ingredient in my product(s) is/are and
their registration number (s) is/are .
My firm will apply for an amendment to the registration prior to changing the source
of the active ingredient in our product.
(4) I understand, and agree on behalf of my firm, that if at any time any portion of
this Statement is no longer true, or if my firm fails to comply with the undertakings
made in this Statement, my firm's product's registration may be suspended under FIFRA
Section 3(c)(2)(B).
(5) I further understand that if my firm is granted a generic data exemption for the
product, my firm relies on the efforts of other persons to provide the Agency with the
required generic data. If the registrant(s) who have committed to generate and submit
the required data fail to take appropriate steps to meet requirements or are no longer
in compliance with this Notice's data requirements, the Agency will consider that both
they and my firm are not in compliance and will normally initiate proceedings to
suspend the registrations of my firm's product(s) and their product(s), unless my firm
commits to submit and submits the required data in the specified time frame. I
understand that, in such cases, the Agency generally will not grant a time extension
for submitting the data.
Registrant's authorized representative:
(Signature)
Dated:
(Typed)
EFA Form 8570-3
143
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CMB Approval No. 2070-0057
Expires 11/30/89
EPA Reg. No..
PRODUCT SPECIFIC DATA REPORT
Date
Guidance Document for
Registration
Guideline No.
Sutpart C
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
1
1
Name of Test
Identity of
inoredients
Statement of
composition
Discussion of
formation of
inaredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Meltira point
Boilina point
Density, bulk-
density, or
specific aravity
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
pH
Test not|
required]
for my |
product j
listed
above
(check
below)
I am complying vdth
data requirements bv
Citing MRID
Number or
EPA Accession
Number
1
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
MRID Numbers
Assigned
EPA Form 8580-4
144
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OMB Approval No. 2070-0057
Expires 11/30/89
EPA Reg. NO..
PRODUCT SPECIFIC DAOA REPORT (cont'd)
Date
Guidance Document for
Registration
Guideline No.
Subpart C
PRODUCT
CHEMISTRY
63-13
63-14
63-15
63-16
Name of Test
Test not
required
for my
product
listed
above
(check
below)
Stability 1
Qxidi zing/reducing |
reaction |
Flammability 1
Explodabi lity
63-17 | Storacie stability
63-18 | Viscosity
63-19 1 Miscibilitv
63-20
63-21
Sec. 158.340
TCeaCOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
81-7
Corrosion
characteristics
Dielectric break-
down voltacte
Acute oral
toxicitv. rat
Acute dermal
toxicity, rabbit
Acute inhalation,
toxicitv. rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion.
Acute Delayed
neurotoxicity. hen
I am complying with
data^ reauirement& bv
Citing t^ID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA. Use Only)
MRID Numbers
Assianed
EPA. Form 8580-4 (cont'd)
-------
EPA Form 8580-6
OMB Approval No. 2070-0057
Expires 11/30/89
1 ' CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
(To otmllfy. cwr/ny 4U four it***) «» DEVELOPMENT OF DATA
1. 1 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)(BI contained in a Guidance Document
lo sutxnit^tfata concerning the active ingredient:
MAMC Of FIRM
•'
GUIDANCE OOCUMCNT OATf
ACTIVE INGREDIENT
CPA 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 thn Notice, if neoetsary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
3. My firm has offend in writing n entar into wen an aanement. Copies of the offers an mached. Thit offer was irrevocable and included an offer to be
bound by an arbitration decision under FIFRA Section J(e)(2)(8)(IS) H fine! agreement on all terms could not be reached otherwise. This offer was made
to the followina. firm(s) on thi following dota(s):
NAMtOtFIMM
OATI OP ornn
However, none of those firm(s) accepted my offer.
4. My firm requests thai EPA not suspend the registration(s) of my firm's product(s). if any of the firmt named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand CPA will promptly inform
me whether my firm mun submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (Thit statement
doe* not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYMONAMt
SIGNATURE
OATI
146
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