United StatM Office of
Environmental Protection Pesticide* and Toxic Subetencee
Agency Washing ton DC 20460 March 1985
Paatickiee
Guidance for the
Reregistration of
Pesticide Products
Containing Picloram
as the Active Ingredient
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GUIDANCE FOR THE
REREGISTRATION OP PESTICIDE PRODUCTS
CONTAINING
PICLORAM
AS THE ACTIVE INGREDIENT
EPA CASE NUMBER: 0096
(005101)
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
March 1985
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TABLE OF CONTENTS
Page
Introduction 1
I. Regulatory Position and Rationale 4
II. Requirement for Submission of Generic Data 28
III. Requirement for Submission of Product-Specific
Data 56
IV. Submission of Revised Labeling 56
A. Label Contents 61
B. Collateral Information 62
V. Instructions for Submission. . 63
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APPENDICES
Page
II-l Guide to Bibliography 66
II-2 Bibliography 68
II-3 FIFRA 53(c)(2)(B) Summary Sheet - EPA Form 8580-1 . . 80
II-4 Certification of Attempt to Enter Into an Agreement
with Other Registrants for Development of Data
EPA Form 8580-2
Xii—1 Product Specific Data Report (End—Use Products) • •
IV-1 40 CFR 162.10 Labeling Requirements 84
IV-2 Table of Labeling Requirements 94
IV-3 physical/Chemical Hazards Labeling Statement. ... 97
IV-4 Storage and Disposal Instructions .... 98
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INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA sec. 3(g)) directs EPA to reregister all pesticides as
expeditiously as possible.
To carry out this task, EPA has established the Regis-
tration standards program, which will review all pesticide
products containing active ingredients first registered before
January 1, 1977. Pesticides will be reviewed in use clusters
which have been ranked to give earliest review to pesticides
used on food and feed crops.
The Registration standards program involves a thorough
review of the scientific data base underlying pesticide
registrations and an identification of essential but missing
studies which may not have been required when the product
was initially registered or studies that are now considered
insufficient. EPA's reassessment results in the development
of a regulatory position, contained in a Registration Standard,
on each pesticide and its uses. The Agency may require the
registrant to modify product labels to provide additional
precautionary statements, restrict the use of the pesticide
to certified applicators, provide reentry intervals, modify
uses or formulation types, specify certain packaging limitations,
or other requirements to assure that proper use of the pesticide
will not result in adverse effects on the environment.
The scientific review, which is not contained in this
Guidance Package but is available upon request, concentrates
on the technical grade of the active ingredient and identifies
missing generic data. However, during the review of these
data we are also looking for potential hazards that may be
associated with the end use (formulated) products that contain
the active ingredient. If we have serious concerns, we will
address end use products as part of the Registration standards
program and will propose regulatory actions to the extent neces-
sary to protect the public.
EPA has the authority under FIFRA sec. 3(c)(2)(B) to
require registrants to submit data that will answer our
questions regarding the hazard that may result from the
intended use of a pesticide. Although sec. 3(c)(2)(B) provides
that all registrants are responsible for these data, the
Agency generally imposes generic data requirements only on the
registrants of of the manufacturing use products (basic
suppliers of the active ingredient). End use producers who
1
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do not qualify for the formulator's exemption* are also
required to submit these data.
An end use producer who wishes to qualify for the formu-
lator' s exemption may change his source of supply to a registered
source, provided the source does not share ownership in
common with the registrant's firm. An end use registrant
may do so by submitting a new Confidential Statement of
Formula, EPA Form 8570-4, identifying the registered source
of the active ingredient, to the appropriate Product Manager
within 90 days of receipt of this Guidance Document. The
chart on the following page shows what is generally required
of those who do and do not qualify for the formulator's
exemption in the Registration Standards program.
If you decide to request the Agency to cancel the regis-
tration of any of your products subject to the requirements
of this Guidance Document, please notify the Product Manager
named in the cover letter, within 90 days from the receipt
of this document. If you decide to maintain your product
registrations), you ©ust provide the information described in
the following pages within the timeframes outlined. EPA will
issue a notice of intent to cancel or suspend the registration
of any currently registered product which does not comply
with the requirements set forth in this Guidance Document,
You are reminded that FIFRA sec. 6(a)(2) requires you to
submit factual information raising concerns of possible
unreasonable adverse effects of a pesticide. You should
notify the Agency of interim results of studies in progress
if those results show possible adverse effects.
~The formulator's exemption applies to a registrant of an
end use product if the source of his active ingredient(s)t
(1) is a registered product and (2) is purchased from a source
which does not have ownership in common with the registrant's
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PRODUCTS SUBJECT TO THEIACTION(S) REQUIRED TO
REGISTRATION STANDARDS PROGRAM | MAINTAIN REGISTRATION
I. Products That Do Not Qualify
For The Formulator's Exemption
A. Single Active Ingredient
Products*
These products must be reregis-
tered. To obtain reregistration,
labeling, packaging and data
requirements must be satisfied
in accordance with the Regis-
tration Standards Guidance
Document.
B. Multiple Active Ingredient
Products
These products will not be
reregistered at this time.
However, generic data required
to cbntinue the registration of
the active ingredient under
review, as described in the
Registration Standards Guidance
Document, will be reauired and
some labeling precautions may
also be reauired.
II
Products That Do Qualify For
The Formulator's Exemption
Only when additional restric-
tions or labeling aire needed to
protect ftah or the environment
will these products be subiect
to the Registration Standard
reguirewettts, Effected products
will be debit with in variety
of ways, including but not
limited to the Label Improvement
Program and fecial intent
to cancel notice^.
* End use products of registrants who also producea manufacturing
use product will not be required to be reregistered,provided that
registrant fulfills the requirements specified in the Guidance
Document for manufact^rir^ ufe product(s) . Such end us«f,;$£b4vfts
will be subiect to the labelIhci chahges required for products in "II"
above. If there are no manufacturina use products registered bv any
company end use products will be required to be reregistered.
NOTE* if all registrants in "I" above fail to meet the requirements in
I-A end B above, than the registrants in "II" lose their rioht to
qualify for the forraulatcir' s exemption and become subiect tp the
rigqireiaents in I-A and B. '¦
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I. REGULATORY POSITION AND RATIONALE
1. INTRODUCTION
This chapter describes the regulatory position of the Environmental
Protection Agency ("the Agency") on picloram based on an evaluation
of all registered manufacturing-use products (MP's) containing
picloram as the sole active ingredient. Future requests for
registration of substantially similar products will be covered
by this standard. Dissimilar products will require amendments
to the standard. This document provides the rationale for the
Agency's position and the criteria for registration. It also
discusses labeling requirements for both MP's and end-use products
(EP's) and tolerances.
In developing its regulatory position, the Agency determines whether
available data indicate that a pesticide has met the criteria for
adverse effects found in S 162.11(a) of Title 40 of the
U.S. Code of Federal Regulations (CFR). Pesticides meeting these
criteria are candidates for a Special Review, an intensive risk/
benefit analysis which is a modification of the Rebuttable
Presumption Against Registration (RPAR) process. The Agency's
determination as to whether any criterion has been met and its
rationale for any regulatory action are summarized in the regulatory
position of this standard.
2. DESCRIPTION OF CHEMICAL AND USE PROFILE
Picloram is the accepted common name for 4-amino-3,5,6-
trichloropicolinic acid which is manufactured solely by the
Dow Chemical Company. Formulations of picloram are sold by
the Dow Chemical under the trade name TORDON* and GRAZON and
by Union Carbide under the trade name AMDON. The Chemical
Abstracts Service (CAS) Registry number is 1918-02-1 and the
Office of pesticide Programs' internal Control Number (EPA
Shaughnessy Number) is 005101.]
Technical picloram is a damp powder substance, off-white to
brown in color, with a chlorine-like odor and a melting point
of 215®C. Picloram is stable in both acidic and basic media.
It is subject to photodecomDOsition by ultraviolet radiation
in aqueous solution. At 25 C pure picloram is soluble in water
at 0.043 grams per 100 milliliters. The vapor pressure of
picloram is 6.2 x 10""^ mm at 35°C and 1.1 x 10""® nun at 45°C.
The empirical formula for picloram is CgH3Cl3N202*
Formulations of picloram include potassium and amine salts with
the potassium and triisopropanolamine salts being the most commonly
used. Liquid product concentrations of picloram range from 0.25
to 2 pounds acid equivalent per gallon while pelleted formulations
of picloram range from 2 to 10 percent acid equivalent by weight.
There are nine EPA registered products currently on the market that
either contain picloram as their sole active ingredient or contain
mixtures of picloram and a phenoxy herbicide.
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3. REGULATORY POSITION AND RATIONALE
Based on a review and evaluation of all the available data
and other relevant information on picloram, the Agency has
made the following determinations:
1. The Agency is requiring precautionary label statements advising
against the use of picloram in very permeable i.e., well-drained
soils such as karst limestone and loamy sands. The Agency
requires the registrants to conduct groundwater monitoring
studies. All picloram products are currently classified as
restricted use pesticides. This classification will remain in
effect with the publication of this standard.
Rationale: Picloram has been found in groundwater and surface
water in West Virginia and was the subject of a public hearing
in that state to determine how picloram entered well water that
was used to irrigate a greenhouse causing the owner to lose most
of his ornamental business. Water contamination and the high
degree of phytotoxicity were the basis for classifying
picloram for restricted use in 1978. The precaution against
use in permeable soils will help prevent such incidents in
the future. The Agency has designated for further study,
certain chemicals including picloram which may have a potential
to enter groundwater supplies in the United States based on
such factors as chemical structure, solubility and use patterns.
Groundwater monitoring studies are needed to determine the
degree to which picloram leaches in different soils.
2. The Agency is granting no new tolerances pending receipt and
review of significant toxiological studies.
Rationale: The established tolerances for picloram are not
supported by the data now available to the Agency. Until significant
toxicological studies are submitted and reviewed and it is
determined whether there are concerns, the Agency cannot consider
any new petitions for tolerances. If the toxicological studies
indicate that additional residue data are required, an assessment of
existing tolerances and new tolerance petitions will be made once
these data are reviewed.
3. The Agency is requiring additional wildlife tests on technical
picloram in order to complete a hazard evaluation. The Agency
is requiring all manufacturing-use products to bear revised
environmental hazard statements reflecting the pesticide's
toxicity to fish and wildlife.
Rationale: Based on studies available to assess hazards to
wildlife and aquatic organisms picloram appears to be moderately
toxic to cold water fish (trout) and slightly toxic to warm
water fish (catfish, bluegill). However, chronic studies on
lake trout suggest that low concentrations of picloram will
adversely affect the rate of yolk sac absorption and growth
of fry. The Agency is requiring additional tests on techni-
cal picloram in order to complete a hazard evaluation,
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and a field monitoring study to determine concentrations
of picloram in runoff water and sediment, leachate, groundwater,
and in water and sediment of receiving aquifers. Updated
label precautions required by this standard should reduce the
hazard to fish and other wildlife.
The Agency is requiring development of analytical methods for
metabolite residues in plant and animal samples and data on
storage stability.
Rationale: Until now, the residue of concern in plants was picloram.
This is no longer the case. The concern now includes picloram and
its metabolites 4-amino-2,3,5-trichloropyridine and 4-amino-3,5-
dichloro-6-hydroxy-picolinic acid. The metabolism of picloram in
animals is only partially understood. No metabolites were found
in animals, and animals differ from plants in this respect. It is
not known if the metabolites were not looked for, were nondetectable,
or were not formed in animals. A metabolism study is needed in
which 14c ring labeled picloram and its metabolites (in proportions
simulating the terminal residues in feed items) are fed to a large
animal (the cow) and to the hen, to determine their carryover,
free or conjugated form, to tissues, milk and eggs. The need to
include these metabolites in tolerances for meat, milk, poultry and
eggs, is deferred until the results of such a study are evaluated.
All of the described methods are acceptable for the collection of
data on residues of intact picloram in plant and animal substrates.
Methods are available and acceptable for enforcement, where it
concerns picloram alone. The Agency needs to know if these
methods also determine residues of picloram and its metabolites
free or conjugated in plant and animal substrates (assuming
these are shown to be present in animals by metabolism studies).
Thus new methodology to determine residues of these previously
undetermined entities may be needed.
The Agency is requiring oncogenicity data and is requiring the
registrant to limit the hexachlorobenzene (HCB) levels in technical
picloram to 200 ppm.
Rationale: The Agency has determined that some studies on
long term effects performed by Industrial Bio-Test Laboratories
(IBT) were invalid due to improper laboratory practices. In
addition, an NCI oncogenicity study on rats and mice fed picloram
was negative for oncogenic effects except in the female rats
treated at 743 mg/kg day; the effects observed were increased
incidences of liver neoplastic nodules. However, the study has
drawn criticism because it was conducted in the same room as other
tested chemicals which have been shown capable of producing
the same lesions. A new replacement study in rats is close to
completion. Other chronic and subchronic studies do not exhibit
oncogenic effects. A multigeneration reproduction study has
produced a NOEL of 3,000 mg/kg. Teratology data on rats exhibit
only slight fetotoxicity at 500 mg/kg, the lowest dosage tested.
A second species teratology study in the rabbit is close to
completion.
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Studies have shown that hexachlorobenzene, a contaminant of
picloraro, is a carcinogen in several species of rodent.
Based on this information the Agency conducted a risk assessment
and has estimated the dietary cancer risk to the general
public of HCB in the fat and milk of cattle fed picloram
treated grass to be 4.6xl0~& to a 70 kg adult and 1.4x10"" ?
to a 10 kg child. These risk estimates are based on 200 ppm
of HCB in currently registered technical picloram. The
Agency has concluded that this risk is acceptable. The
Agency will impose a maximum limitation of 200 ppm of HCB in
technical picloram and is requiring the registrant to submit
a revised confidential statement of formula to reflect this
required limit.
6. The Agency is requiring data on technical picloram for nontarget
area phytotoxicity.
Rationales picloram is highly phytotoxic, easily absorbed by
roots and foliage. In soils not subject to leaching it is
very persistent with phytotoxicity being detected in some
cases well over one year after application. The Agency has
determined that damage to nontarget plants is occurring.
Phytotoxicity data will be required because the Agency is
unable to ascertain whether this damage is a result of appli-
cator error, misuse, drift, leaching, runoff or persistence.
In addition, the Agency has contacted the Department of
Interior's office of Endangered species (OES) to request a
biological opinion for picloram on non crop sites. OES has
already provided the Agency with biological opinions on
rangeland pesticides and forest pesticides. irPicloram was
included among the pesticides .evaluated in both of these
clusters. For these clusters, OES listed a number of endangered
plants that could be jeopardized when picloram is used within
their habitat. OES concluded "As a reasonable and prudent
alternative to preclude jeopardy, these chemicals should not
be used within or adjacent to habitats of these plants."
The Agency may amend this Standard to reflect the OES recom-
mendations once the required data have been submitted.
7. While the data gaps are being filled, currently registered
manufacturing-use products containing picloram as the sole
active ingredient may be sold, distributed, formulated and
used in the United States, subject to the terms and conditions
specified in this Standard.
Rationale: The evidence now before the Agency does not indicate
that the continued use of picloram poses significant risks to
human health or the environment. Thus, there is no basis, at
this time, for a Special Review. With the restricted use
classification and precautionary labeling requirements in this
Standard, it is the Agency's judgment that continued use of
picloram does not cause unreasonable adverse effects on the
environment. Although numerous data gaps exist, it is not the
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policy of the Agency to cancel or withhold registrations
solely because of data gaps. (See $ 3(c)(2)(B) and 3(c)(7)
of FIFRA.) When the data gaps are filled in response to
this standard, the Agency will evaluate whether a change in
its regulatory position is necessary.
Registrants must provide or agree to develop additional data,
as specified in Tables A and B attached to this guidance docu-
ment, within 90 days after receipt of this document, in
order to maintain existing registrations or to permit new
registrations of substantially similar picloram MPs. These
data must be submitted within the time frames indicated in
the data tables.
Rationale: The Agency requires the data specified in the
data tables to complete its evaluation of picloram and to
determine if any risk or adverse effects to human health or
the environment may result from the use of picloram.
The Agency is requiring registrants to place certain precau-
tionary statements on the labels of manufacturing-use and
end—use products containing picloram.
Rationale: precautionary statements are required on labels
as a means of minimizing exposure of the pesticide to humans and
to the environment,
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loram have drift to non-target areas. Preliminary drift
studies done using picloram showed phytotoxic effects up to
800 feet downwind in winds of 5 to 10 mph. The additional
studies will be performed to determine the appropriateness
the current label statements: "...Microfoil Boom or equivalent
drift control system..." and "Except when applying with a
Microfoil Boom a spray thickening agent, such as NALCO-TROL,
should be used with this product to aid in reducing spray
drift..."
12. The Agency considers the different forms of picloram (acid, salts,
esters) to be toxicologically similar so that all of these forms
are covered by this single Registration Standard. In most cases,
testing on the acid form of picloram fulfills the data requirements
for all forms of picloram.
Rationale: Technical esters and salts of picloram are sold as
manufacturing use products and sometimes as formulations. These
forms of picloram are considered toxicologically similar to the
acid form of picloram so that, in general, testing on the acid
form represents testing on the other forms. For certain tests,
however, the acid form is not suitable due to its physical
properties and one of the other forms must be tested. These
exceptions are noted in the data requirements tables. In
addition, the Agency's registration guidelines require
acute toxicity testing on each of the acids, salts and esters
of picloram for labeling purposes.
13. The Agency has established upper limits of 1 ppm for the presence
of nitrosamines in the technical product.
Rationale: Nitrosamine may be a potential contaminant of the
various amines used to produce the amine salts of picloram.
This chemical is regulated under that rule which requires
testing to show that a level of 1 ppm of nitrosamine contamination
is not exceeded (45 FR 42854]. These testing requirements
are reflected in the data tables at the end of this dpcument*
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4. CRITERIA FOR REGISTRATION UNDER THIS STANDARD
To be covered under this Standard, products must contain picloram
as the sole active ingredient, bear required labeling, and conform
to the product composition, acute toxicity limits, and use pattern
requirements listed in section 5 of this document.
The application for registration or reregistration of products
subject to this Standard must comply with all terms and conditions
described in it, including submission of an up-to-date Confidential
Statement of Formula, submission of revised labeling, commitment
to fill data gaps on a schedule specified by the Agency and, when
applicable, offer to pay compensation as required by s 3(c)(1)(D)
and S 3(c)(2)(D) of the Federal Insecticide, Fungicide and Rodenticide
Act (FIFRA), as amended, 7 U.S.C. § 136a(c)(1)(D) and S 136a(C)(2)(D).
Registration applicants must contact the Agency for specific
instructions, including updated information on data requirements
and companies whose data must be cited and to whom compensation
must be offered.
5. ACCEPTABLE RANGE AND LIMITS
1• Product Composition Standard
To be fully covered under this Guidance Document, manufacturing-use
products must contain picloram as the sole active ingredient.
Each manufacturing-use product formulation proposed for registration
or reregistration must be fully described and an appropriate
certification of limits must be included. The label must also state
the minimal concentration for the active ingredient. In addition,
the active ingredient found in the manufacturing-use picloram
products must be substantially similar to that in currently
registered technical products. Any manufacturing-use product not
meeting these requirements will be considered a new product and will
not be registered under this standard.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade and
manufacturing-use products containing picloram, provided that
the product labeling bears appropriate precautionary statements
for the acute toxicity category in which each product is placed.
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3. Use Patterns
To be registered under this Standard, manufacturing-use
products containing picloram may be labeled for formulation
into end-use products only for the sites listed below. The
attached index entry lists all registered uses, as well as
approved maximum application rates and frequencies.
Picloram is applied on Rights-of-way, forest site preparation,
pasture and range lands, and small grains. In the control of
woody plants picloram is used on alder, aspen, birch, cherry,
backgum, sweetgum, locust and many species of maple. Railroads
use it for brush control and also for the control of vines
such as Virginia creeper, honeysuckle, various morning-glories,
and milkweed vine. Both railroads and highway departments
use picloram to control perennial weeds such as bouncing bet,
wild carrot, thistles, golden rod, milkweed and leafy spurge.
In addition to woody plant control, it is an important tool for
forest site preparation in the southeastern United States because
of its ability to control kudzu and honeysuckle.
On permanent grass pastures in the eastern half of the United
States, picloram is used primarily for the control of two
woody plant species. These are hawthorn and multiflora rose.
On rangeland in the western states, picloram is used to control
bitterweed, knapweed, leafy spurge, locoweed, larkspur, mesquite,
prickly pear, and snakeweed, in Nebraska, Montana, Wyoming,
Minnesota and the Dakotas, it is used to control wild buckwheat
and thistles in small grain such as wheat, oats, and barley.
4. Required Labeling
All manufacturing-use picloram products must bear appropriate
labeling as specified in 40 CPR 162.10. The guidance
package for this standard contains information on label
requirements. All labeling changes must appear on all products
released for shipment one year from the date the Standard
is issued. All labeling changes must appear on all products
in channels of trade two years from the issuance date of the
Standard.
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In addition to the above, the following information must appear
on the labeling:
1. Ingredient Statement
The ingredient statement for MP's must list the active
ingredient ass
Picloram (4-amino-3,5,6-trichloropicolinic acid)
2. Use Pattern Statements
All manufacturing-use picloram products must state that
they are intended for formulation into end-use herbicide
products for the aforementioned use patterns. Labeling
must specify sites, which are listed in Use Patterns,
Section 5.3. No use may be included on the label
where the registrant fails to agree to comply with the
data requirements in either TABLE A or TABLE B for
that use pattern.
3. Precautionary Statements
Statements for Manufacturing-Use Products
a. Labels for manufacturing-use picloram products must
bear statements reflecting the compound's toxicity.
Picloram is in Toxicity Category III by all routes
of exposure; the required precautionary statements
associated with this category are specified in 40
CFR 162.10.
b. The following revised environmental hazard statements
must appear on all MP's labels:
"Do not discharge effluent containing this
product into lakes, streams, ponds,
estuaries, oceans or public waters unless this
product is specifically identified and addressed
in an NPDES* permit. Do not discharge effluent
containing this product into sewer systems
without previously notifying the sewage
treatment plant authority. For guidance, contact
your State Water Board or Regional Office of the
Environmental protection Agency."
* NPDES * National Pollutant Discharge Elimination System
12
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Statements for End-use products
a. The following "restricted use" statement must appear
on the label of all picloram products:
"Restricted Use Pesticide"
"Potential for groundwater contamination. Toxic
to non-target plants."
"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."
"Picloram is a chemical which can travel (seep or
leach) through soil and can contaminate ground water
which may be used as drinking water. Picloram has
been found in ground water as a result of agricultural
use. Users are advised not to apply picloram where
the soils are very permeable, i.e., well-drained soils
such as karst limestone and loamy sands. Your
local agricultural agencies can provide further
information on the type of soil in your area
and the location of ground water."
b. For rotated crops: "Do not rotate food or feed crops
on treated land if they are not registered for use
with picloram."
c. For ditch bank uses: "Water contaminated with
residues of picloram from ditch bank uses shall
not be used to irrigate crops which are not
registered for use with this chemical."
d. For picloram mixtures with 2,4-D: "WARNING: Avoid
contact with skin, eyes or clothing. Avoid repeated
skin contact since sensitizing reactions may occur."
e. For non-aquatic uses: "Do not apply directly to
water or wetlands. Do not contaminate water by
cleaning of equipment or disposal of wastes."
f. For aquatic uses: "Consult your State Fish and
Game Agency before applying to public waters.
Permits may be required before treating such
waters. Do not apply directly to water except
as directed on the labeling. Do not contaminate
water by cleaning of equipment or disposal of
wastes."
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4. Tolerance Reassessment
The established tolerances for picloram have been reassessed
and found not to be supported by the available data. U.S.
tolerances for negligible residues of picloram in or
on raw agricultural commodities are as follows (40 CFR 180.
292)
1
0 ppm
Barley, Forage, Green
0
5 ppm
Barley, Grain
1
0 ppm
Barley, Straw
0
2 ppm
Cattle, Fat
5
0 ppm
Cattle, Kidney
0
5 ppm
Cattle, Liver
0
2 ppm
Cattle, MBYP (except kidney and liver)
0
2 ppm
Cattle, Meat
0
05 ppm
Eggs
0
5 ppm
Flax, Seed
0
5 ppm
Flax, Straw
0
2 ppm
Goats, Fat
5
0 ppm
Goats, Kidney
0
5 ppm
Goats, Liver
0
2 ppm
Goats, MBYP (except kidney and liver)
0
2 ppm
Goats, Meat
80
0 ppm
Grasses, Forage
0
2 ppm
Hogs, Fat
5
0 ppm
Hogs, Kidney
0
5 ppm
Hogs, Liver
0
2 ppm
Hogs, MBYP (except kidney and liver)
0
2 ppm
Hogs, Meat
0
2 ppm
Horses, Fat
5
0 ppm
Horses, Kidney
0
5 ppm
Horses, Liver
0
2 ppm
Horses, MBYP (except kidney and liver)
0
2 ppm
Horses, Meat
0
05 ppm
Milk
1
0 ppm
Oats, Forage, Green
0
5 ppm
Oats, Grain
1
0 ppm
Oats, Straw
0
05 ppm
Poultry, Fat
0
05 ppm
Poultry, MBYP (except kidney and liver)
0
05 ppm
Poultry, Meat
0
2 ppm
Sheep, Fat
5
0 ppm
Sheep, Kidney
0
5 ppm
Sheep, Liver
0
2 ppm
Sheep, MBYP (except kidney and liver)
0
2 ppm
Sheep, Meat
1
0 ppm
Wheat, Forage, Green
0
5 ppm
Wheat, Grain
1
0 ppm
Wheat, Straw
There are no CODEX MRL's or Mexican tolerances for
picloram. The food uses on barley are acceptable in
Canada on a negligible residue basis (0.1 ppm picloram).
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EPA's tolerance of 0.5 ppm for residues of picloram in
barley grain is higher. Once the additional data being
required are received and reviewed, the Agency will determine
whether harmonization with the Canadian limit is possible.
It is concluded that the metabolism of picloram in wheat, and
in grasses generally, is adequately understood, and the nature
of the residue is known. It consists predominantly of picloram,
free or conjugated, and of 4-amino-2,3,5-trichloropyridine and
4-amino-3,5-dichloro-6-hydroxy-picolinic acid, free or possibly
conjugated. In view of the concern over the two metabolites,
they should be included in the tolerance with picloram.
The metabolism of picloram in animals is only partially under-
stood. No metabolites were found in animals, and animals
differ from plants in this respect. It is not known if the
metabolites were not looked for, were nondetectable, or were
not formed in animals. A metabolism study is needed in which
14C-tagged picloram and its metabolites (in proportions sim-
ulating the terminal residues in feed items) are fed to a
large animal and to the hen, to determine their carryover,
in free or conjugated form, to tissues and milk. The need to
include these metabolites in tolerances for meat, milk, poultry
and eggs, is deferred until the results of such a study are
evaluated.
15
-------
EPA Index to Pesticide Chemicals
PICLORAM
16
-------
EPA Index to Pesticide Chemicals
PICLORAM* h005101
TYPE PESTICIDE: Herbicide
FORMPLATIOWS» Rot located.
GENERAL WARNINGS AND LIMITATIONS: There are currently no registered pro-
ducts containing this chemical.
TIME REQUIRED FOR COHTROL: Rot located.
PHYTOTOXICITY TO TARGET WEEDS: Rot located.
P1YTOTDXICITY TO CROPS: Hot located.
MODE OF ACTIOH: Rot located.
*4-aaino-3f3,6-trichloropicolinic acid
Issued: 4-07-79 1-005101-1
17
-------
EFA Index to Pesticide Chemicals
PICLORAM, TRIISOPROPANOLAMINE SALT*
rr?ftz/sr.
h005102
TYPE PESTICIDE; Herbicide
FOHMULATIOHS: EC (0.37 lb/gal)
GENERAL WARNINGS AND LIMITATIONS; An herbicide used to control woody
and herbaceous plants in noncrop areas.
TIME REQUIRED FOR CONTROL: Not located.
PHYTOTOXICITY TO TARGET WEEDS: Not located.
PHYTOTOXICITY TO CROPS: Not located.
MODE OF ACTION: Not located.
WOODY PLANTS CONTROLLED:
ash
aspen
locust
6PDMAC/
0PEOAB4
0PCQBQ/
@PACAfii
§PBWAF7
9PDDAH/
gPELASi)
aaple
oak
pine
rose
*4-aaino-3,5,6-trichloropicolinic acid, triisopropanolaaine salt.
Issued: 1-30-80 1-005102-1
18
-------
EFA Index to Pesticide Chemicals
Site. Dosage Tolerance. Pse. Limitations
and Formulation
RIGHTS-OF-WAY
Utility Rights-of-Way N.F.
— TX state label
Registration Number 011465-10170
Formulated with ailvex, isooctyl ester plus
2,4-dichlorophenoxyacetic acid, triisopropanol
amine salt.
COMMERCIAL AMD INDUSTRIAL PREMISES
Noncrop Areas N.F.
— TX state label
Registration Number 011465-10170
Formulated with ailvex, isooctyl ester plus
2,4-dichlorophenoxyacetic acid, triisopropanol
amine salt.
FOREST. NONAGRICPLTPRAL AND WASTELANDS
Noncrop Areas N.F.
— TX state label
Registration Number 011465-10170
Formulated vith silvex, isooctyl ester plus
2,4-dichlorophenoxyacetic acid, triisopropanol
amine salt.
/6700600
F
/670000C
F
/670000C
Issued: 1-30-80
1-005102-2
19
-------
EPA Index to Pesticide Chemicals
PICLORAM, TRIISOPROPANOLAMINE SALT
Listing of Registered Pesticide Products by Formulation
0.37 lb/gal emulsifiable concentrate
picloran, triisopropanolaaine salt (005102), 2,4-dichlorophenoxyacetic
acid, triisopropanolaaine salt (030035) plus silvex, isooctyl ester
(082565)
011465-10170
Issued: 1-30-80
>005102-3
20
-------
SPA index to Pesticide Chemicals
PICLORAM, POTASSIUM SALT*
A
/&u~
005104
CTPE PESTICIDE< Herbicide
FORMULATIONSi PI (34.7%), P/T (11.6%, 5.8%, 2.3%), SC/L (2 lb/gal)
GENERAL INFORMATION: Restricted Use Pesticide. X brush and broadleaf
weed control herbicide that can remain active in
the soil for more than one season. It is highly
mobile in the soil and can be transported laterally
in subsurface water. Dosages for this chemical were
calculated using the acid equivalent (a.e.).
TIME REQUIRED FOR CONTROL* Mot located.
PHOTOTOXICITY TO TARCET WEEPSi Leaf shape is altered at low dosage» tips
of new leaves may be narrow; puckering
of young leaves may occuri bending or
splitting of stem may occur.
MOPE OF ACTIONI Alters nucleic acid and protein synthesisi a variety of
ensymes may be affected.
LIVESTOCK TOLERANCES:
0.5 ppm in liver of cattle, goats, hogs, horses, and Sheepi 5 ppm in
kidney of cattle, goats, hogs, horses, and sheepr 0.2 ppm in meat, fat
and meat byproducts (other than kidney and liver) of cattle, goats, hogs,
horses, and sheep; 0.05 ppm in milk, eggs, and in the meat, fat and meat
byproducts of poultry.
BROADLEAT WEEDS CONTROLLED*
Canada thistle
dalaatioa toadflax
dock
field bindweed
larkspur
leafy sparge
milkweed
perennial sowthistle
pigweed
plumeless thistle
povertyweed
pricklypear
Russian knapweed
silverleaf nightshade
skeletonleaf bursage
sowthistle
sunflower
tansy
toadflax
(b)
(a)
(a)
(b)
(a)
(b)
(b)
(a)
(a)
(a)
(a)
(b)
(b)
(b)
(b)
(b)
(a)
(a)
(b)
PBFAWBB
PEOAIBB
PEAAHAA
PBGACBB
PEHAFAA
PBVAGBE
PAHAAAB
PBPDCBA
PAAAABI
PBFAQBA
PB7CCBA
PASACAA
PBPARBI
PEMAIBD
PBFBMBC
PBFDCAA
PBPBUAA
PB7D6BA
PEUAIAA
* 4-amino-3,5,6-trichloropioolinic acid, potassium salt
Xssoedi 11-15-81 1-005104-1
21
-------
EPA Index to Pesticide Chemicals
PICLORAM, POTASSIUM SALT
WOODY PLANTS CONTROLLED;
aspen
brambles
conifers
grape
hawthorn
huisache
juniper
kudzu
locust
aaple
nultiflora roae
wfaitebrush
Iseuedt 11-15-81
1-005104-2
22
-------
EPA Index to Pesticide Chemicals
FICLORAM, POTASSIUM SALT
Site, Doeacre
and Formulation
(lb a.e./A)
Tolerance, Pee. Limitation*
ACRICULTURAL CROPS
Qraee pastures
grass rangelanda
1-4
(5.8-11.6% P/T)
AGRICOLTORAL FRIM1S1S
Around farm
buildings, fence-
rova, etoraqe areas.
1-3
(2.3* 9/9)
2-3
(2 lb/gal SC/L)
80 ppm (forage graaaea)
for rates in excess of 3 lb a.e. At Do not
grace dairy animals in treated areas or cut
grass for hay for 16 weeks after treatment;
and rsaove meat animals for three days prior
to slaughter when gracing treated area within
16 weeks after treatment. Limit coverage to no
greater than 25% of an applicator's acreage,
found in any particular watershed. Do not use
where a sandy porous surface and substrata
overlie ground water 10 feet or less below the
surface. Where watersheds have significant
slcpa and whare rapid runoff can occur, use spot
treatments only.
Ose limited to AL, AR, CO, OA, ICS, K3T, LA, MO, MS,
"C» Ml# OK, SC, to, TX, VA» W. Broadcast or spot
treatment. Apply to individual noxious plants, to
cluaqps, and to larger danse infestations where
grasses are already suppressed. Apply anytime soil
is not frosen. Do not retreat areas by broadcast
application for at least three years. Applications,
especially at higher rates, may injure or suppress
certain desirable graaaea such as smooth brosM-
grass western wheatgrass, and switehgrass; do not
•PPlY where possible injury to such graaaea cannot
be tolerated. Grass seedlings may be suppressed
or killed for up to 2 years after application,
seeding during this period is not recoonanded.
nr
22013AA
22032AA
66000AA
Broadcast or spot treatment for broadleaf weed
control. Apply anytime daring the growing
season, and preferably whan rainfall can be ex-
pected soon after application, in araaa whare
little or no summer rainfall occurs, apply in
late suamsr or aarly fall. Apply the SC/L to:
ulation in 50-100 gallons of water.
Issued! 11-15-81
1-005104-3
23
-------
EPA Index to Pesticide Chemicals
PICLORAM, POTASSIUM SALT
Site. Dosage
and Formulation
(lb. a.a./A)
Tolerance, Use, Limitations
AGRICULTURAL PREMISES (continued)
6-8
(2.3% P/T)
0.25-2.0
(2 lb/gal SC/L)
Broadcast or spot treataent for woody plant
control. Apply uniformly to the soil over the
root sone anytime during the normal growing
season where sufficient moisture is available or
carry the herbicide into the soil. Where little
or no summer rainfall occurs, apply at bud break
in late winter or early spring.
For an extended rangei of broadleaf weed control;
and for improved control of rootsuckering woody
locust, sassafras and
ned by using either
is lower dosage for annual
, the middle of the range
if weeds and susceptible
species such as aspen
sumac than could be
chemical alons. Use
broadleaf weed contro
for perennial broadl
woody spades, and the upper end of the range for
hard-to-control woody
spray volume of 15-25
as an invert emulsion
species. Apply in a total
gallons per acre. Tank mix
with propylene glycol butyl
sther 2,4-dichloropheloxyacetate; or as a water
based spray with butoicypropyl 2,4-dichlorophenoxy-
acetate.
RIGHTS-OF-WAY
Riqhta-of-wav
COMMERCIAL MP
INDUSTRIAL PREMISES
Industrial sites
FOBEST. CHAPARRAL.
MOWAGRICULTURAL AMD
Forests
1-4
(5.8-11.6 F/*)
NF
Refer to AGRICULTURAL! PREMISES.
67013AA
NF
Safer to AGRICULTURAL1 PRMiimft.
67009AA
NF
Broadcast or spot treatment. Apply to individual
noxious plants, to clumps, and to larger
infestations. Apply (anytime soil is not frosen.
30000AA
Issuedt 11-15-81
1-005104-4
OA
-------
KPA Index to Pesticide Chemicals
PICLORAM, POTASSIUM SALT
Site. Dosage Tolerance. Pse. Limitations
and Formulation
(lb a.e./A)
AOOATIC AREAS
(adjacent to water)
Outer ditch banks MP 65013AA
2-3 Broadcast or spot treatment for broadleaf weed
(2 lb/gal SCA) control. Apply an time daring the growing
season, and preferably when rainfall can be ex-
pected soon after application. Apply in 50-100
gallons of water.
Issuedi 11-15-81
1-005104-5
25
-------
SPA Index to Pesticide Chemicals
PICLORAM, POTASSIUM SALT
Listing of Registered Pesticide Products by Formulation
34.7% (30% a.e.) Formulation intermediate
Picloram, potassium salt (005104)
000464-00502
3.3% (2% a.e*) Pelleted/Tableted
Picloram, potassium salt (005104)
000464-00333
5»8% (5% a.e») Pelleted/Tableted
Picloram, potassium salt (005104)
000464-00541
11.6% (10% a.e.) Pelleted/Tableted
Picloram, potassium salt (005104)
000464-00320
2 lb/gal soluble concentrate A.iau±d
Picloram, potassium salt (005104)
000464-00323 000464-00421
State Label Registrational
CA Reg. Mo.
000464-07099
CO Rag. MO.
000464-07098
HI Rag. No.
000464-07097
ID Rag. No.
000464-07096
MM Reg. Mo.
000464-07095
NT Rag. MO.
000464-07094
MS Rag. Mo.
000464-03383
ND Rag. Mo.
000464-07092
OS Rag. MO.
000464-07091
SD Rag. Mo.
000464-07090
000464-07103
000464-07102
000464-03385 000464-04528 000464-07093
000464-07101
Issued: 11-15-81 1-005104-6
-------
SPA Xndax to Paaticid* Chaalcals
PICLORAM, POTASSIUM SALT
Stat* Labal Ragiatrationa (contlnuad)
OT Rag. No.
000464*07089
HA Rag. Mo.
000464-07088
WT Rag. Hp.
000464-67100
wr Rag. Ho.
000464-07087
Iaauadt 11-15-81
1-005104-7
27
-------
II. REQUIREMENT FOR SHBMISSION OF GENERIC DATA
A. This portion of the guidance document is a Notice
issued under the authority of FIFRA sec. 3(c)(2)(B). The
tables following this section list the data required for
maintaining the registrability of each oroduct.
EPA has determined that additional generic data described
in Table A must be submitted to EPA for evaluation in order
to maintain in effect the registrations) of your product(s)
identified as an attachment to the cover letter accompanying
this guidance document. As required bv FIFRA sec. 3(c)(2)(B),
you are required to take appropriate steps to comply with
this Notice.
EPA may suspend the registration of each of those products
unless, within the specified time, you have informed EPA how
you will satisfy the requirements of this Notice. Any such
suspension will remain in effect until you have complied with
the terms of this Notice.
B. What Generic Data3-/ Must be Submitted. You may deter-
mine which generic data you must submit by consultina Table A
at the end of this chapter. That table lists the generic
data needed to evaluate the continued registrability of all
products, and the dates by which the data must be submitted.
The required studies must be conducted in accordance with
EPA approved protocols (such as those contained in the Pesticide
Assessment Guidelines 2/ or data collected under the approved
protocols of the Organization for Economic Cooperation and
Development (OECD). If you do not wish to develop data
in support of certain uses appearing in your labeling, you
may delete those uses at the time you submit your revised
labeling.
For'certain kinds of testing (generally ecological
effects), EPA requires the test substance to be a "typical
formulation," and in those cases RPA needs data of that type
1/ Generic data pertain to the properties or effects of a
particular ingredient, and thus are relevant to an evaluation of
the risks of all products containing that ingredient, regardless
of the product's unique composition or specific use. Product-
specific data relate only to the properties or effects of a
product with a particular composition (or a group of products
with closely similar composition).
2/ The Pesticide Assessment Guidelines are available in hard
copy or microfiche from the National Technical Information
Service, 5205 Port Royal Road, Springfield, Va. 22161.
28
-------
for each major formulation category (e.g., emulsifiable concen-
trates, wettable powders, granuiars, etc.) These are classified
as generic data and when needed are specified in Table A.
EPA may possess data on certain "typical formulations" but
not others. Note: "Typical fbrmulation" data should not be
confused with product-specific data (Table B) which are
reguired on each formulation. Product-specific data are
further explained in Chapter III of this document.
C. Options Available for Complying With Reguirementa
to Submit Data
Within 90 days of your receipt of this Notice you must
submit to EPA a completed copy of the form entitled "FIFRA
Section 3(c)(2)(B) Summary Sheet" [EPA Form 8580-1, Appendix
II-3] for each of your products. On that form you must state
which of the following methods you will use to comply with
the requirements of this Notice:
1. (a) Notify EPA that you will submit the data, and
(b) either submit the existing data you believe will
satisfy the requirement, or state that you will generate
the data by conducting testing. If the test procedures
you will use deviate from (or are not specified in) the
Pesticide Assessment Guidelines or protocols contained in
the Reports of Expert Groups to the Chemicals Group,
Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must enclose the
protocols you will use.
OR
2. Notify EPA that you have entered into an agreement
with one or more other registrants to iointly develop (or
share in the cost of developing) the data. If you elect
this option, you must notify EPA which registrant(s) are
parties to the agreement.
OR
3. Pile with EPA a completed "Certification of Attempt to
Enter Into an Agreement With Other Registrants for Develop-
ment of Data" (EPA Form 8580-6, Appendix II-4)*/
*/ FIFRA sec. 3(c)(2)(B) authorizes joint development of
data By two or more registrants, and provides a mechanism by
which parties can obtain an arbitrator's decision if they agree
to jointly develop data but fail to agree on all the terms of
the agreement. The statute doe.s not compel any registrant to
agree to develop data jointly.
(Footnote continued on next page)
-------
OR
4. Request that F.PA amend vour reaistration bv deletina
the uses for which the data are needed. (This option is
not available to applicants for new products.)
OR
5. Reauest voluntary cancellation of the reqistration(s)
of your products for which the data are needed. (This option
is not available to applicants for new products.)
D. Procedures for Requesting Changes in Testing Methodology
and Extensions of Time"
EPA recognizes that you may disagree with our conclusions
regarding the appropriate wavs to develop the required data
or how quiclcly the data must be submitted. If the test
procedures you plan to use deviate from (or are not specified
in) the registration guidelines or protocols contained in
the reports of the Expert Groups to the Chemical Groups,
Organization for Economic Cooperation and Development (OECD)
Chemicals Testing Programme, you must submit the protocol
for Agency review prior to the initiation of the test.
If you think that you will need more time to generate the
required data than is allowed by EPA's scheduler you may
submit a request for an extension of time. The extension
request must be submitted in writing to the Product Manager.
(Footnote continued from previous page)
In EPA's opinion, joint data development by all regis-
trants subject to a data requirement, or a cost-sharing agreement
among all such registrants is clearly in the public Interest.
Duplication of testing could increase costs, tie up testing
facilities, and subject' an unnecessarily large number of
animals to testing.
As noted earlier, EPA has discretion to suspend the
registration of a product when a registrant fails to submit data
required under PIPRA Section 3(c)(2)(B). EPA has concluded that
it should encourage joint testing rather than duplicative
testing, and that suspension should be withheld in certain cases,
to further this goal. Accordingly# if (1) a registrant has
informed us of his intent to develop and submit data required
by this Notice; and (2) a second registrant informs EPA that
it has made a bona fide offer to the first registrant to share
in the expenses of the testing Ton terms to be agrfed upon
or determined by arbitration under PIPRA Section 3(c)(2)(B)(iii) 1:
and (3) the first registrant has declined to agree to enter
into a cost-sharing agreement, EPA will not suspend the
second firm's registration.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PICLORAM
Data Requirement
Does EPA Haw Data.
To Sf.t'.rr" T\\b
.1/. .. Requirement? (Yes,
Composition Wo or Partially)
~27
Bibliographic
Citation
Must Additional
Data Be Submitted
Dnder FIFRA Section
3(c)(2)(B)?
§158.120 Product Chemistry
Product Identity and Composition:
61-1 - Product Identity and Disclosure
of Ingredients
TGAI
61-2 - Description of Beginning TGAI
Materials and Manufacturing Process
61-3 - Discussion of Formation of TGAI
Impurities
Analysis and Certification of Product
Ingredients:
62'1 - Preliminary Analysis of Product TGAI
Samples
62-2 - Certification of Ingredient TGAI
Limits
Yes
Yes
Yes
No
No
00096376
00096376
00096376
No
NO
No
Yes
Yesf/
62-3 - Analytical Methods to Verify TGAI
Certified Limits
Physical and Chemical Characteristics:
63-2 - Color TGAI
63-3 - Physical State TGAI
63-4 - Odor TGAI
63-5 - Melting Point TGAI
63-6 - Boiling Point TGAI
63-7 - Density, Bulk Density, or
Specific Gravity TGAI
Partially
Yes
Yes
Yes
Yes
1/
N/A
Yes
00036172
Yes
00036149
00036149
00036149
00036149
00036149
No
No
NO
No
NO
31
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PICLORAM
Data Requirement
Composition
Does EPA Have Data
To Satisfy This
1/ Requirement? (Yes,
No or Partially)
Bibliographic
Citation
2/
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
§158.120 Product Chemistry (continued)
63-8 - Solubility
63-9 - Vapor Pressure
63—10 — Dissociation Constant
*
63-11 - Octanol/Water Partition
Coefficient
63-12 - pH
63-13 - Stability
Other Requirementst
64-1 - Submittal of samples
TGAI or PAI
PAI
PAI
PAI
TGAI
TGAI
Yes
Yes
Yes
Yes
Yes
Yes
00036149
00036149
00036149
00036149
00036149
00036149
No
No
No
No
No
No
N/A~
3/
1/
U.
3/
i/
Composition; TGAI « Technical grade of the active ingredient; PAI = Pure active ingredient.
Data must be submitted no later than 6 months from the receipt date of this Standard.
NA ® Not applicable for purposes of this Standard.
Opper and lower limits must be provided (and certified) for the active ingredient and each impurity present at
_> 0.1% w/w in the technical product. Certified upper limits for the presence of hexachlorobenzene (HCB) must
not exceed 200 ppa. Certified upper limits for the presence of nitrosoamines must not exceed 1 ppm.
^3
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PICLORAM
Data Requirement
Does EPA Have Data
To Satisfy This
V Use2/ Requirement? (Yes,
Composition Pattern Mo or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
§ 158.130 Environmental Fate
DEGRADATION STODIES—LAB:
161-1 - Hydrolysis
Photodegradation
161-2 - In water
161-3 - On soil
161-4 - In Air
METABOLISM STUDIES-LAB8
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
MOBILITY STUDIES;
163-1 - Leaching and
Adsorption/Desorption
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
TGAI or PAIRA A,B,D,G
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TEP
TEP
A,B,D,G
A,G
A
A,B,G
A
D
D
TGAI or PAIRA A,B,D,G
A
A
Partially
Partially
Mo
N/A
Partially
Tea
Ho
Mo
Partially
N/A
M/A
GS0096-001
00059425
00111415
00111515
00128976
00111504
00111441
00128976
00044009 00111473
00044017 00111422
00096247 00111516
00128977
YesV
YesjV
Yes
No£/
YesV
No
Yes
Yes
Yes1j
No£/
Mo8/
33
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PICLORAM
Data Requirement
V 0se2/
Composition Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
Mo or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Onder FIFRA Section
3(c)(2)(B)?3/
§ 158.130 Environmental Fate (continued)
DISSIPATION STODIBS-FIKLD:
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and
Tank Nixes
-164-5 '- Soil, Long-term
ACCUMULATION STOPIBS:
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
163-3 - Irrigated Crops
163-4 - In Fish
TEP
TEP
TEP
TEP
TEP
PAIRA
TEP ¦
A,B
D
G
TGAI or PAIRA
D
A,B,D,G
163-3 - In Aquatic Nontarget
Organisms TEP
Subpart K Reentry
Ground Water Monitoring
Partially
Partially
Partially
N/A
Yes
Ho
Mo
Mo
Yes
No
No
00044004
00044014
00044018
00044023
00059416
00111436
00111493
00111494
00111515
00111526
00111533
00128957
00128958
00128963
00111475
00128977
00128981
00128987
GS0096-002
GS0096-003
GS0096-004
00111491 GS0096-003
00128956 GS0096-004
00140317
00044023
00111515
00128947
00128948
Yesf/
Yes10/
Yes11/
No^2/
No
Yea13/
Yes13/
Yes14/
No15/
No16/
Yes17/
3-V
-------
1/ Composition: TGAI = Technical grade of the active ingredient? PAIRA = Pure
active ingredient, radiolabeled; TEP - Typical end-use product.
2/ The use patterns are coded as follows: A = Terrestrial, Pood Crop; B = Terrestrial
Nonfood, c - Aquatic, Food Crop; D = Aquatic, Nonfood, E = Greenhouse, Food Crop;
F = Greenhouse, Nonfood, G = Forestry, H = Domestic Outdoor; I * Indoor.
2/ (a) Data for Hydrolysis 161-1, Photodegradation 161-2/3, and Leaching
and Adsorption/Desorption 163-1 must be submitted no later than 6 months
from the receipt date of this standard.
(b) Data for Soil Metabolism 162-1 and Field Dissipation 164-1
¦ust be submitted no later than 2 years from the issue date of this
Standard.
-------
11/ Additional data are needed to support both pellet and solution formulations
i>% at least a, typical Southeastern forest preparation site.
\2f Date requir ements for combination ana uuik mixes are not necessary for
the purposes of this standard.
12/ For crops rotated on treated areas any one of the following will apply:
(aj A tolerance Bust be obtained for the rotated crop.
(b) The product label Bust include a restriction against the rotation
of crops used for food or feed on treated areas.
(c) Data must be provided to determine time intervals at which crops
planted on treated areas will be free of pesticide residues.
V4/ In instances where water from treated drainage ditches becomes contaminated
with pesticide residues, any one of the following will apply: (a) A tolerance
must be obtained for any crop exposed to contaminated water, (b) The product
label must include a restriction against the use of water containing picloram
residues on cti$b grown for food or feed, (c) Data must be provided to
demonstrate conditions under which water exposed to treated drainage ditches
can be used on crops without resulting in illegal plant residues.
J5/ Data are not required since laboratory studies indicate that picloram
does not accumulate significantly in fish tissue.
13J Mo data are required since picloram does not meet the criteria outlined
in 40 era 158.140 for reentry protection data requirements.
3
-------
17/ Retrospective Field Study for Piclorara
A retrospective field study for picloram is required, in choosing a site for
this study the following should be considered:
1) A detailed history of picloran usage on the field should be known,
including dates and rates (kg/ha) of application. Application of
the granular or pellet formulation is preferable to liquid.
2) The picloram should be applied uniformly over the field site.
This criterion would negate applications on electrical utility right-of-
way fence-rowr etc. Picloram uses which would meet this criterion
include pasture-rangeland or forest site preparation. (Applications to wheat
also meet this criteria, but most of the rates of application are so low as to
negate these uses for consideration.)
3) Hie soil texture on this field should be coarse so as to enhance
leaching. Soil textures meeting this criterion include all sands and loams -
those not meeting this criterion include silts and clays.
4) At least two or three wells should be within 1 mile of this field
site and down gradient of the ground water flow path. These wells should be
shallower than 50 feet, indicating that at least a perched water table exists.
If wells are not already present, they can be drilled or driven for the
purposes of this study. If this is done, nested wells should be created.
5) Some hydrogeology of the area should be known, particularly the
depth to ground water. This information could be obtained from the well
builders.
A suggested use pattern which meets these criteria is forest site preparation
on the coastal Southeast. Reasons for choosing this use include: 1) picloram
use in forest site preparation occurs primarily in the Southeast, 2) the
history of use would have to be well known since the picloram is only applied
once (the picloram should have been applied within 2 years of the first data
collection), 3) soil textures which meet the criterion 4) above are prevalent
on the Southeast coast, particularly in Florida, and 5) the intensity of
spring and summer storms is conducive to leaching in this part of the country.
37
-------
Once a field site has been located, the study will be designed. A
preliminary set of considerations includes:
t) The soil should be well characterized in terns of percent sand, silt,
and clay fractions, percent organic matter, pH, water-holding capability.
This characterization should extend from the surface to at least 10 feet
deep.
2) Between five and ten soil cores should be taken at one or
within a period of a couple of weeks. These cores will be used to characterize
the soil (#1 above) and to describe the spatial distribution of picloraa in
the field. The pattern of sampling should be well thought out in order to
lend statistical significance to the study design. Each soil core should
extend at least 10 feet deep, and separate samples at 6-inch to 1-foot
increments should be analyzed for total picloram.
3) well water samples should be taken quarterly (or 4 times/year).
4) Do all this for two similar fields.
38
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PICLORAM
Data Requirement
Does EPA Have Data
To Satisfy This
V Use2/ Requirement? (Yes,
Composition Pattern Ho or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
j 158.135 Toxicology
ACUTE TESTING:
81-1 - Oral
Rat
81-2 - Dermal
Rabbit
TGAI-Acid
TIPA Salt A,B,G
IPA Salt A,B,G
Isooctyl ester A,B,G
K+ Salt A,B,G
K+ Salt A, B,G
TGAI-Acid
TIPA salt A,B,G
IPA salt A,B,G
Isooctyl ester A,B,G
No
No
No
Yes
No
No
No
No
No
Yes
GS0096-005
GS0096-005
YesV
Yes
Yes
No
Yes
Yes
YesV
Yes
Yes
No
81-3 Inhalation
Rat
81-6 - Sensitization
TGAI-Acid
TIPA Salt A,B,G
IPA Salt ArB,G
Isooctyl ester A,B,G
X+ Salt A,B,G
2,4-D Picloram A,B,G
TIPA sail:
Tordon 22K A,B,G
No
No
No
No
No
Yes
Yes
00041114
00041115
00128765
GS0096-006
No
Yes
Yes
Yes
Yes
No
No
No
3H
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PICLORAM
Data Requirement
Does EPA Have Data
To Satisfy This
V Ose^/ Requirement? (Yes,
Composition Pattern No or Partially?
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?3/
| 158.135 Toxicology (continued)
CHRONIC TESTING:
83-1 - chronic Toxicity
2 species: Rodent TGAI-Acid
Nonrodent TGAI-Acid
83-2 - Oncogenicity Study
2 species: Rat TGAI-Acid
Mouse TGAI-Acid
83-3 - Teratogenicity
2 species: Rat TGAI-Acid
Rabbit TGAI-Acid
A,B,G
A, B,G
A,B,G
A,B,G
A,B,G
A,B,G
No
NO
Partially
Yes
Yes
No
00081275
00081275
00030284
YesV
YesV
YesV
No
No
YesV
83-4 - Reproduction,
2-generation
MOTAGBHICITY TESTING:
84-2 - Gene Mutation
84-2 - Chromosomal
Aberration
TGAI-Acid
TGAI
TGAI
84-2 - Other Mechanisms of TGAI
Mutagenicity
AfB,G
Yes
00041098
No
A,B,H,I
A,B,H,I
A,B,H,I
Partially
No
No
00123282
Yes£/V
Yes£/7/
Yes6/7/
HO
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PICLORAM
Data Requirement
1/
Composition
Use2/
Pattern
Does EtA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
§ 158*135 Toxicology (continued)
SUBCHRGNIC TESTING:
82-1 - 90-Day Feeding -
Rodent
non-rodent
TGAI-Acid
TIPA
TGAI-Acid
A,B,G
A,B,G
A, B,G
Yes
Yes
Yes
00041093 00069969
00098317 00110537
00041094
00115034
No
No
No
82-2 - 21-Day Dermal
TGAI-Acid
A,B,G
No
-
No
82-3 - 90-Day Dermal
TGAI-Acid
A,B,G
No
-
No
82-4 - 90-Day Inhalation
TGAI-Acid
A,B,G
No
-
No
82-5 - 90-Day Neurotoxicity
TGAI-Acid
A,B,G
No
No
SPECIAL TESTING:
85-1 - General Metabolism
PAI or PAIRA of
Acid, K-Saltr
Salt
A,B,G
Partially
00098321
00011409
YesV
85-2 - Domestic Animal
Safety
Choice
A,B,G
Yes
00128765
No
GS0096-006
No
H
-------
GENERIC DATA REQUIREMENTS FOR PICLORAM
1J Composition: TGAI = Technical grade of the active ingredient; TEP = Typical end-use product.
PAI = Pure active ingredient; PAIRA = Pure active ingredient, radiolabeled. Choice =» Choice of
several test substances determined on a case-by-case basis; TIPA = Triisopropanolamine salt;
IPA = Isopropylamine.
2/ The use patterns are coded as follows: A = Terrestrial, Pood Crop; B = Terrestrial, Nonfood, C « Aquatic,
Pood Crop; D = Aquatic, Nonfood, E = Greenhouse, Food Crop, F = Greenhouse, Nonfood, G = Forestry,
H = Domestic Outdoor, I = indoor.
3/ Data must be submitted no later than 1 year from the receipt of this Standard.
4/ If the picloraa is an in-house intermediate, further acute testing of the technical is not warranted.
5/ Data must be submitted no later than 3 years from the receipt of this Standard.
6/ Data must be submitted no later than 1 year from the receipt of this Standard.
7/ See data requirement and guidelines for appropriate mammalian in vitro test to cover area of
genetic toxicity.
-------
TABLE A
GBiERIC DATA REQUIREKQITS FOR PICLORAM
Data Requi rementg
Composition1/
Does EPA Have Data
To Satisfy This
Use Requirement? (Yes
Pattern2/ Mo or partically)
Bibliographic
Citation
Mast Additional^/
Data be Submitted
Onder FIFRA Section
3(c)(2)(B)?
$150.142 Spray Drift
201-1 - Droplet Size Spectrum
202-1 - Drift Field Evaluation
TEP
TIP
B,G
B,G
Ho
Mo
Yes
Yes
V Composition: TEP » Typical end-use product.
2/ Use Pattern: B - Terrestrial, Nonfood Crop; G ~ Forestry.
3/ Data must be submitted no later than 1 year from receipt of this Standard.
43
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PICOLORAM
Data Requirement
§158.145 Wildlife and
Aquatic Organises
AVIAN AND MAMMALIAN TESTING;
71-1 - Avian Oral LD50
71-2 - Avian Dietary LC50
71-3 - Wild Mammal Toxicity
71-4 - Avian Reproduction
71-5 - Simulated and Actual
Field Testing -
Mammals and Birds
AQUATIC ORGANISM TESTING:
70-1 - Special Test (Monitoring)
72-1 - Freshwater Pish LC50
Does EPA Have Data
To Satisfy This
V Use 2/ Requirement? (Yes,
Composition Pattern Ho or Partially)
Bibliographic
Citation
3/
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
72-2 - Acute LC50 Freshwater
Invertebrates
72-3 - Acute IC50 Estuarine
and Marine Organisms
TGAI(acid) A,B,
(and potassium salt)
TGAI (acid) A,B
TGAI(potassium
salt, isooctyl ester)
ArB
TEP
B
TGAI(acid) A,B
(salt, isooctyl ester)
TGAI(acid) A,B
TGAI
B
No
Yes
No
No
No
N/A
No
Yes
Yes
00022923
GS0144-012 00129078
00112016 GS0096-007
00129076
GS0144-012
00129076
GS0096-008
Partially 00111560
00129073
3/
Yes
No
Yes
No
No
No
1/
Yes
5/
No
«/
No
No
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PICLORAM
Data Requirement
1/ 2/
Composition Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
V
Must Additional
Data Be Submitted
Dnder FIFRA Section
3(c)(2)(B)?
AVIAN AMD MAMMALIAN TESTING:
72-4 - Fish Early Life
Stage and Aquatic
Invertebrate Life-Cycle
72-5 - Fish Life-Cycle
TGAI(acid) A,B
(salt, isooctyl ester)
TGAI(acid) A,B
(salt, isooctyl ester)
No
No
V
Reserved
7/
Reserved
72-6 - Aquatic Organism
Accumulation
No
No
72-7 - simulated or Actual
Field Testing -
Aquatic organisms
No
1/
Reserved
1f Composition! TGAI * Technical Grade of the active ingredient? TEP » Typical end-use product.
2/ The use patterns are coded as follows: A - Terrestrial, Food Crop; B = Terrestrial, Non-Crop; C <* Aquatic,
Food Crop; D = Aquatic Nonfood; E ¦ Greenhouse, Nonfood; G = Forestry; H = Domestic outdor; I = Indoor.
2/ Use bobwhite quail (waive mallard duck species at this time).
4/ Data must be submitted 6 months from the receipt of this Standard. Support use on forestry, ditch banks,
rangelands,( potassium salt liquid and pellet). Pending these results, residue monitoring may be required on the
isooctyl ester, at a later date.
5/ Waive the requirements for other acute fish studies because of similarity in toxicity values noted in previously
submitted studies (acid, salt, isooctyl ester).
6/ Waive requirements for other aquatic invertebrate studies on salt and isooctyl ester. This is based on the
~ acute toxicity values from other aquatic studies that showed slight toxicity.
7/ These tests may be required pending the ????
-------
TABLE A
GQiERIC DATA REQUIREMENTS FOR PICLORAM
Data Requi rements
Does EPA Have Data
To Satisfy This
V Use 2/ Requirement? (Yes,
Composition Pattern No or Partially)
Bibliographic
Citation
2/
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
jl58.150 Plant Protection
121-1 - TARGET AREA
PHOTOTOXICITY; EP
HONTARGET AREA PHYTOTOXICITY:
Tiro I
122-1 - Seed Germination/
Seedling Emergence TGAI
122-1 - Vegetative Vigor TGAI
122-2 - Aquatic Plant Growth TGAI
TIER II
123-1 - Seed Germination/ TGAI
Seedling Emergence
123-1 - Vegetative Vigor TGAI
123-2 - Aquatic Plant Growth TGAI
TIER III
124-1 - Terrestrial Field TEP
124-2 Aquatic Field TEP
B
B
B
B
B
B
B
B
Mo
Mo
Mo
No
5/
Reserved
Reserved
5/
1
5/
Reserved
6/
Reserved
6/
Reserved
4/
No
Yes
Yes
Yes
4/
No
V Composition: TGAI =» Technical grade of the active ingredient; TEP = Typical end-use product.
EP = End-use product.
2/ Hie use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Nonfood Crop; C = Aquatic,
Food Crop; D = Aquatic, Nonfood; E = Greenhouse, Food Crop; F = Greenhouse, Nonfood; G = Forestry;
H « Domestic Outdoor; I = Indoor.
3/ Data must be submitted no later than 6 months from receipt of the Standard.
4/ These requirements are generally waived unless EPA determines that there is a phytotoxicity problem.
5J Reserved pending evaluation of Tier I results.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PICLORAM
Data Requirement
Does EPA Have Data
To Satisfy This
1/ Ose2/ Requirement? (Yes,
Composition Pattern Mo or Partially)
Bibliographic
Citation
Mast Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
§1S8.155 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORS:
141-1 - Honeybee acute
contact
141-2 - Honeybee - toxicity
of residues on
foliage
141-4 - Honeybee subacute
feeding study
141-5 - Field testing for
pollinators
NONTARGET INSECT TESTING -
AQOATIC 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
TGAI, A,B,G
Potassium salt,
Isooctyl ester
TEP
A,B,G
TGAI, Potassium salt,
Isooctyl ester
TEP
A,B,G
TGAI, Potassium salt
Isooctyl ester
TGAI, Potassium salt
Isooctyl ester
TGAI, Potassium salt
Isooctyl ester
143-1 - NONTARGET INSECT TESTING-
thru PREDATORS MP PARASITES: TGAI, Potassium salt
143-3 Isooctyl ester
Yes
No
00036935
No
No4/
Reserved®/
No
No4/
Reserved^/
Reserved^/
Reserved^/
Reserved6/
* 7
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PICLORAM
1/ Composition: TGAI - Technical grade of the active ingredient; TEP = Typical end-use product.
^ Pa"Srna ar« coded ®® follows: A " Terrestrial, Pood Crop; B = Terrestrial, Nonfood,* c = Aquatic
Pood Crop; D = Aquatic, Nonfood; E = Greenhouse, Food Crop; F = Greenhouse, Nonfood, G = Forestry-
H = Donestic Outdoor; I ¦ indoor. y'
3/ Data mist be submitted no later than 6 months from receipt of this Standard.
4/ As data from the acute test indicate low toxicity to bees, no further testing is required.
5/ Reserved pending development of test methodology.
6/ Reserved pending Agency decision as to whether the data requirement should be established.
49
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PICLORAM
Data Requirements
Composition
Does EPA Have Data
To Satisfy This
\J Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
Mist Additional
Data Be Submitted
Onder FIFRA Section
3(c)(2)(B)?
§158,125 Residue Chemistry
171-4 - Nature of Residue (Metabolism)
- Plants PAIRA
- Livestock PAIRA
171-4 - Residue Analytical Method
- plant residues
- Animal residues
171-4 - Storage Stability Data
TGAI &
Metabolites
Yes
Partially
Partially
TGAI & Metabolites Partially
00011527 00041136
00059411 00037880
00023105 00041125
00041126 00041123
00026751 00045363
00026752 00045366
00027288 00045409
00026750
00069973
00073974
00073972
00078483
No
2/'
Yes
V*
Yes
3/1
Yes
PAIRA
No
A/*
Yes
1/ Composition: TGAI = technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabeled; TEP =
Typical end-use product; EP = End-use product.
2/ A metabolism study is needed in which 14C ring labeled picloram and its metabolites (in proportions simulating the
terminal 14q residues in feed items) are fed to a ruminant and to the hen, to determine their carryover, in free or
conjugated form to tissues, milk, and eggs.
3/ Hew methodology may be needed to determine the previously undetermined entities (metabolites, free or conjugated)
~~ in plant animal tissues (assuming these are shown to be present in animals by the required metabolism studies).
4/ Data on the storage stability of residues of picloram and its metabolites free or conjugated in plant and animal
samples are required.
*/ Data must be submitted no later than 1 year from receipt of this Standard.
4*
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PICLORAM
Data Requirements
Composition
Does EPA Have Data
To Satisfy This
1J Requirement? (Yes,
Ho, or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Dnder PIPRA Section
3(c)(2)(B)?
$158.125 Residue Chemistry (continued)
171-4 - Magnitude of the Residue -
Residue studies for each
food use
- Grain Crops of
Wheat, Barely, Oats TEP
- Processed Foods
Milled Fractions TEP
- Forage and Straw of
Barley, Oats, Wheat TEP
- Flaxseed and Straw
- Forage Grasses TEP
Partially
Partially
Partially
Partially
Partially
00128714 00036186
00036171 00036170
00045369
00128714
00036171
00085060
00026753
00128714
00111470
0011527
00036186
00036170
2/ 3/ 4/«
7es
2/ 3/ 4/*
Yes
2/ 3/ 4/*
Yes
2/ 3/ 6/*
Yes
2/ 3/ 4/ SJ*
Yes
1/ Composition: TGAI " Technical grade of the active ingredient; PAIRA ¦ Pure active ingredient, radiolabeled;
TEP =¦ Typical end-use product.
2/ If metabolites in the plant and animal tissues are not determined by current methodology, new data may be needed on
on residues of picloram and its metabolites, free or conjugate, in cropland and animal tissue.
3/ Data are needed on storage stability.
4/ Data are needed to reflect ground and aerial application.
SJ Better geographical representation in major growing areas is needed.
6/ If new data show that residues in fact are present in flaxseed new data for residues in hulls and meal will be needed.
V Data must be submitted no later than 1 year from receipt of this Standard.
S'O
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PICLORAM
Data Requirements
Does EPA Have Data
To Satisfy This
V Requirement? (Yes,
Composition Ho, or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
§158.125 Residue Chemistry (continued)
Residue studies in food-
producing animals
- Meat TGAI
- Milk TGAI
- Poultry TGAI
- Eggs TGAI
Partially
Partially
Partially
Partially
00073973 00045374 Yes
00045376
00045372 Yes
00073921
00035959 Yes
00035959 Yes
2/ 3/*
!
2/ 3/*
i
2/ 3/*
2/ 3/*
JJ Composition: TGAI = Technical grade of the active ingredient; PAIRA * Pure active ingredient, radiolabeled; TEP =
Typical end-use product; BP = End-use product.
2/ If metabolites in the plant and animal tissues are not determined by current methodology, new data may be needed on
residues of picloram and its metabolites, free or conjugate, in cropland and animal tissue.
3/ Data are needed on storage stability.
2J Data must be submitted no later than 1 year from the receipt of this Standard.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING—USE PRODUCTS OF PICLORAM
Data Requirement
Composition
1/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS OF PICLORAM
1/ Acid ¦ Picloram Acid; TIPA = Triisopropylamine Salt of Picloram; IPA = Isopropylamine salt of piclorara; K+ = Potassium
— salt of picloram; IOE = Isooctyl ester of picloram.
2/ Data must be submitted 6 months after receipt of this Standard.
NOTE: These testing requirements may be satisfied by table A if they are the same as the Technicals.
^*3
-------
TABLE B
PRODUCT SPECIFIC MOP REQUIREMENTS
Data Requirewent
Composition
Does' EPA Have Data
To Satisfy This
1/ Use^/ Requirement? (Yes,
Pattern Ho or Partially)
Mast Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?3/
Physical and Chemical
Characteristics:
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-7 - Density, Bulk Density,
or Specific Gravity
63-12 - pH
63-14 - Oxidizing/Reducing
Action
63-15 - Flammability
63-16 - Explodability
63-17 - Storage Stability
63-18 - Viscosity
63-19 - Miscibility
HUP
IftJP
MOP
HUP
MUP
MUP
MOP (for combustible
liquids only)
MUP
MUP
MUP (for liquid
Products)
MUP (for emulsifiable
liquid products)
Yes
Yes
Yes
No
Yes
No
No
No
Yes
No
No4/
00036149
00036149
00036149
00036149
00036149
No
No
No
Yes
No
Yes
Yes
Yes
No
Yes
Yes4/
63-20 - Corrosion
HOP
Yes
No
St
-------
TABLE B
PRODUCT SPECIFIC MOP REQUIREMENTS
Data Requirement
Composition^/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Mast Additional^/
Data be Submitted
Under FIFRA Section
3(c)(2)(b)?
158.120 Product Chemistry
Product Identity:
61-1 - Product Identity &
Disclosure of Ingredients
HOP
61-2 - Description of Beginning HUP
Materials and Manufacturing Process
61-3 - Discussion of Formation of
Impurities
MOP
Analysis and Certification of Product Ingredients;
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3 - Analytical Methods for
Enforcement of Limits
MOP
MOP
MOP
Yes
Yes
Yes
No
No
Partially
00096376
00096376
00096376
00096376
No
No
No
Yes
Yes
Yes
1j Table reflects the status of data requirements for the MOP of Picloram which is equivalent to the table A. All
of the requirements of tills table would apply to a new MUP.
2/ Data must be submitted no later than 6 months from the receipt of this Standard.
3/ Data must be submitted no later than 6 months from the receipt of this Standard.
4/ These data requirements are not applicable.
-------
The extension request should state the reasons why you believe
that an extension is appropriate. While EPA considers your
request, you must strive to meet the deadline for submitting
the required data.
111• REQUIREMENT for submission of product-specific data
Note: Unless stated otherwise in Section I, Regulatory
Position and Rationale, this Section applies only to manufac-
turing use products, not to end use products.
A necessary first step in determining which statements
must appear on your product's label is che completion and
submission to EPA of product-specific data* listed on the
form entitled "Product Specific Data Report" (EPA Form
8580-4, Appendix III-l) to fill "gaps" identified by EPA
concerning your product. Under the authority of FIFRA sec.
3(c)(2)(B), EPA has determined that you must submit these
data to EPA in order to reregister your product(s). All of
these data must be submitted not later t^han six months after
you receive this guidance document.
Table B—Product-Specific Data Requirements for Manufacturinq
Use Products—lists the product specific data you must submit.
Data that are required to be submitted are identified in the
column of those tables entitled "Must Data By Submitted
Under |?3(c)(2)(B) ."
IV, SUBMISSION OF REVISED LABELING
Note: This section applies to end use droducts only to the
extent described in Section I (Regulatory Position and
Rationale). Otherwise, the following information pertains
exclusively to manufacturing use produces.
FIFRA requires each product to be ljabeled with accurate,
complete and sufficient instructions and! precautions, reflecting
the results of data concerning the product and its ingredients.
Labeling requirements are set out in 40 CFR 162.10 (see
Appendix IV-1) and are summarized for products containing
this active ingredient as part of this Guidance Document
(See Appendix JV-2). Applications submitted in response to
this notice must include draft labeling for Agency review.
*/ Product specific data pertain to data] that support the
formulation which is marketed; it usually includes product
chemistry data and acute toxicity data.
56
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If you fail to submit revised labeling information
complying with this section (supplemented by requirements
described in Section I, Regulatory Position and Rationale),
.EPA may issue a notice of intent to cancel the registration
under PIPRA sec. 6(b)(1).
A. Label Contents
40 CPR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling. Specific label items
listed below are keyed to Appendix IV-2.
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. See Appendix iv-l. [40 CPR
162.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying^phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Aqency. See Appendix IV-1.
[40 CPR 162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
See Appendix IV-1. [40 CPR 162..10(f)]
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Item 6. INGREDIENTS STATEMENT - An inqredients 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. See Apoendix iv-l. [40 CFR
162.10(g)]
Item 6A. 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
on Front Panel
in Square Inches
5 and under
above 5 to 10
above 10 to 15
above 15 to 30
over 30
Signal Word
Minimum Type Size
All Capitals
6 point
10 point
12 point
14 point
18 point
"Keep Out of Reach
of Children"
Minimum Type Size
6 point
6 point
8 point
10 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. See Appendix IV-1.
r40 CFR 162.10(h)(1)(ii)J
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. See Appendix IV-1.
[40 CFR 162.10 (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. See Appendix IV-1. [40 CFR 162.10(h)(1)(i)]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. See Appendix IV-1. [40 CFR 162.10(h)(1)(iii)]
58
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Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
recruired on the front panel for all products, unless all
required precautionary statements appear on the front panel
See Appendix IV-1. MO CFR 162.10(h)(1)(iii)l
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear toaether
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. See Appendix IV-1. [40 CPR 162.10
(h)(2)].
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. See Appendix IV-1. [40 CFR 162.10
(h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are reauired stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, iniury, or damage. See Appendix IV-1. [40 CFR
162.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD
!• Flammability statement. Precautionary statements relating
to flammability oc a product are reauired to appear on the
label if it meets the criteria in Appendix Iv-3. The require-
ment 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.
2- Criteria for declaration of non-flammabilitv. The
following criteria will be used to determine if a product
is non-flammable;
a. A "non-flammable gas" is a gas (or mixture of gases)
that will not ignite when a lighted match is placed
against the open cylinder valve.
b. A "non-flammable liquid" is one having a flashpoint
greater than 350®F (177,#C).
59
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c. A "non-flammable aerosol" is one which meets the
following criteria:
i. The flame extension is zero inches;
ii. There is no flashback; and
iii. The flashpoint of the non-volatile liquid
component is greater than 350®F (177*C).
3. Declaration of non-flammability. Products which
meet the criteria for non-flammability specified
above may bear the notation "non-flammabie" or "non-
flammable (gas, liquid, etc.)" on the label, it may
appear as a substatement to the ingredients statement,
or on a back or side panel, but shall not be highlighted
or emphasized (as with an inordinately large type
size) in any way that may detract from precaution.
4. Other physical/chemical hazard statements. When
chemistry data demonstrate hazards of a physical or
chemical nature other than flammability, appropriate
statements of hazard will be prescribed. Such statements
may address hazards of explosivitv, oxidizing or reducing
capability, or mixing with other substances to produce
toxic fumes.
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 apDlicators
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 I
indicates why the product has been classified for restricted
use)* or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR 162.11(c). You will be notified of
the Agency's classification decision.
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A. Classification Labeling Requirements
If Section I of this Guidance Document indicates that
your product has been classified for restricted use/ the
following label requirements apply:
1. Front panel statement of restricted use classification.
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 CPR 162.10(h) (1) (iv)'
b. Directly below this statement on the front panel,
a summary statement of the terms of restriction must
appear (including the reasons for restriction if
specified in Section I). If use is restricted to
certified applicators, the following statement is
required: "For retail sale to and use only by
Certified Applicators or persons under their direct
supervision and only for those uses covered by the
Certified Applicator's Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label uses that
are unrestricted, but you may not distinguish them
on the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may "split" your registration# i.e., register
two separate products with identical formulations» one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
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B. Compliance Schedules
No product with a use classified for restricted use
under this Standard may be released for shipment bv the
registrant or producer after one year from the date of
issuance of this Standard, unless such product bears the
restricted use classification. All products still in
channels of trade after two years from the date of issuance
of this Standard must be labeled for restricted use.
Item 9B. [There is no Item 9B].
Item 9C. MISUSE STATEMENT - All products must bear the
misuse statement/ "It is a violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
Item 10A. REENTRY STATEMENT - If a reentry interval
has been established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983.
Item 10B. [There is no Item 10B],
Item IOC. 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 bie grouped and
appear under the headincr "Storacre and Disposial" in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warnincr. Refer to Appendix
IV-4 to determine the disposal instructions appropriate for
your products.
Item 10D. DIRECTIONS FOR USE - Directions for use must
und understood by
rise the use of
ft be adequate to
be stated in terms which can be easily read
the average person likely to use or to superi'
the pesticide. When followed, directions mui
protect the public from fraud and from persqnal injury and to
prevent unreasonable adverse effects on the environment. See
Appendix IV-1. [40 CFR 162.10]
B* Collateral Labeling
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other 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.
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V. INSTRUCTIONS FOR SUBMISSION
All applications prepared in response to this Notice should
be addressed as follows:
Robert J. Taylor
Registration Division (TS-7S7C)
Office of Pesticide Programs
Environmental Protection Aqency
Washington, D.C. 20460
Phone No. (703)557-1800
A. For Manufacturing Products (MP) containing (name of
pesticide) as an active ingredient.
1. Within 90 days from receipt of this document, you must
submit the "FIFRA Section 3(c)(2)(B) Summary Sheet" EPA Form
8580-1. Refer to Appendix II-3 with appropriate attachments.
2. Within 6 months from receipt of this document you must
submit:
a. Confidential Statement of Formula, EPA Form 8570-4.
b. Product Specific Data Report, EPA Form 8580-4
(Appendix III-1).
c. Two copies of any required product-specific data.
d. Two copies of draft labeling, including the label and
associated brochures. If current labeling conforms to the
requirements of this guidance document and the results of
the short-term data, vou may submit such labeling. End use
product labeling must comply specifically with the instructions
in Section I (Reaulatory Position and Rationale) of this
guidance document. The labeling should be either typewritten
text on 8-1/2 x 11 inch paper or a mockup of the labeling
suitable for storage in 8-1/2 x 11 inch files. The draft
label must indicate the intended colors of the final label,
clear indication of the front panel label, and the intended
type sizes of the text.
e. Evidence of compliance with data support requirements
of FIFRA sec. 3(c)(1)(D). Refer to PR Notice 84-4 (enclosed)
for latest requirements.
3. Within the times set forth in Table A, all generic data
must be submitted.
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Note: If for any reason any required test is delayed or
aborted so that the aqreed schedule cannot be met. notify
the Product Manager. y
B* for Manufacturing Ose Products containing (name of pesticide
in combination with other active ingredients
90 davs from receipt of this document, you must
e "FIPRA Section 3(c)(2)(B) Summary Sheet," EPA Form
8 580-1. Refer to Appendix II-3 with appropriate attachments.
2* Within the times set forth in Table A, all generic data
must be submitted.
Note: If for any reason any required test is delayed or
aborted so that the agreed schedule cannot be met, notify
the Product Manager.
C. For End Ose Products containing (name of pesticide) alone
or in combination with other active ingredients:
Within 90 days from receipt of this document, you must
submit the "FIFRA Section 3(c)(2)(B) Summary Sheet," EPA Form
8580-1. Refer to Appendix II-3 with appropriate attachments.
2- Within 6 months from receipt of this document vou mush
submit: y ^
a. Confidential Statement of Formula, EPA Form 8570-4.
b. Product-Specific Data Report, EPA Form 8580-4
(Appendix III-l).
c. Two copies of any required product-specific data
(Refer to Table C).
d. Two copies of draft labeling, including the label and
associated brochures. If current labeling conforms to the
requirements of this guidance document and the results of
the short-term data, you may submit such labeling. End use
product labeling must comply specifically with the instructions
in Section I (Regulatory Position and Rationale) of this
guidance document. Labeling should be either tvDewrit<-»n
text on 8 1/2 x 11 inch paper or a mockup of the labelino
suitable for storage in 8 1/2 inch files. The draft label
must indicate the intended colors of the final label clear
indication of the front panel label, and the intended ^
sizes of the text. yp
e. Evidence of compliance with data support reoui«ments
Refer t0 PR "°tlee 84-<
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3. For those end use product registration that are not
eligible for the formulator's exemption, submit all oeneric data
within the time set forth in Table A.
6. For intrastate products containing (name of pesticide)
either as the sole active ingredient or in combination
with other active ingredients.
These products are being called in for full Federal
registration. Producers of these products are being sent
a letter instructing them how to submit an application for
tftgistration.
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Appendix II-l
Guide to Use of This Bibliography
1. CONTENT OP 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 OP 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 subiecjt), can stand alone for purposes of review,
and can be described with a conventional bibliocrraphic
citation. Thp Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OP 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 entrjies. This temporary identifier number is
also to be usied whenever specific reference is needed.
4. FORM OP 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 ithe American National Standards Institute
(ANSI), expanded to provide for certain special needs.
66
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Appendix Il-l (continued)
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.
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.
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.
Trailinq 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-As the second, 123456-
B: the 26th, 123456-Z; and the 27th, 123456-AA.
67
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard For Picloram
MRID Citation
00011409 Ciba-Geigy Corporation (1977) Reports of Investigations Made with
Respect to the Safety of the Pesticide Supradde 2E. Summary of
studies 230815-B through 230815-E. (Unpublished study received
Jul 7, 1977 under 100-501; CDL:230815-A)
00011527 Peterson, G.W. (1967) Dothistroraa needle blight of Austrian and
ponderosa pines: Epidemiology and control. Phytopathology 57
(?/Apr):437-441. (Also In unpublished submission received Dec
30, 1970 under 1109-25; submitted by Cities Service Co., Miner-
als Group, Atlanta, Ga.; CDL:024579-H)
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, Ioxynil, 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)
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 s^udy received Nov 21 1967
under 8F0660; CDL:091151-M)
00026753 Leahy, J.S.; Taylor, T. (1967) A gas-chroraatographic determination
of residues 1n 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)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard For Plcloram
MR ID Citation
00030284 Thompson, D.J.; Emerson, J.L.; Strebing, R.J.; et al. (1972) Tera-
tology and postnatal studies on 4-Am1no-3,5,6-trfchlorop1col1n1c
acid (Plcloram) 1n the rat. Food and Cosmetics Toxicology 10
(? ):797-803. (Also 1n unpublished submission received Jan 15,
1980 under 464-323; submitted by Dow Chemical U.S.A., Midland,
Mich.; CDL:241615-A)
00035959 Riley, V.; Kutschinskl, 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)
00036149 Dow Chemical Company (19??) Name, Identity, and Structure of the
Pesticide Chemical: [Plcloram], (Unpublished study received
Jul 3, 1975 under 6F1653; CDL:094499-A)
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(R) 202 Mixture): GHP-913. (Unpublished study received
Jul 3, 1975 under 6F1653; prepared 1n 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 Plcloram and 2,4-D 1n 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)
00036172 Dow Chemical Company (1975) Analytical Method: Plcloram Technical.
Method No. 60180 under May 28, 1975. (Unpublished study re-
ceived Jul 3, 1975 under 6F1653; CDl:094499-W)
00036186 Allied Chemical Corporation (1959) Urab: Weed Killers: 1959 Agri-
cultural Development Bulletin. (Unpublished study received Jul
23, 1959 under 218-446; CDL:001098-A)
00036935 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1975) Toxicity of
Pesticides and Other Agricultural Chemicals to Honey Bees: Labo-
ratory Studies. By University of California, Dept. of Entomolo-
gy. ?: UC, Cooperative Extension. (Leaflet 2287; published
study.)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard For Plcloram
MRID Citation
00037880 Melkle, R.W.; Williams, E.A.; Redemann, C.T, (1966) Metabolism of
Tordon herbicide (4-Am1no-3,5,6-trichlorop1col1n1c acid) 1n cot-
ton and decomposition In soil. Journal of Agricultural and Food
Chemistry 14(4):384-387. (Also 1n unpublished submission re-
ceived Jun 6, 1973 under 2F1265; submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL:092164-N)
00041093 Dow Chemical Company (1962) Results of 90-Day Dietary Feeding Stud-
ies of 4-Am1no-3,5,6-tr1chlorop1col1n1c acid in Rats. (Unpub-
lished study received Nov 6, 1967 under 0F0863; CDL:094525-C)
00041094 Dow Chemical Company (1964) Results of 90-Day Dietary Feeding Stud-
ies of Tr11sopropanolamine salt of 4-Amino-3,5,6-tr1chlorop1co-
Unic acid 1n Rats. (Unpublished study received Nov 6, 1967 un-
der 0F0863; prepared 1n cooperation with International'Research
and Development Corp; CDL:094525-D) "esearcn
00041098 McCollister, D.D.; Copeland, J.R.; Oyen, F. (1967) Results of Fer-
tility and Reproduction Studies 1n Rats Maintained on Diets Con-
taining Tordon(R) Herbicide. (Unpublished study received Nov
6, 1967 under 0F0863; submitted by Dow Chemical U.S.A Midland
Mich.; CDL:094525-H) " nia,ana»
00041114 Dow Chemical Company (1964?) Skin Contact Studies with Humans
Summary of studies 094525-Z through 094525-AC. (Unpublished
study received Nov 6, 1967 under 0F0863; CDL:094525-Y)
00041115 Hill Top Research Institute, Incorporated (1963) Repeated Insult
Patch Test of M-2431 and Three Other Unrelated Materials (Un-
published study received Nov 6, 1967 under 0F0863: submitted bl
Dow Chemical U.S.A., Midland, Mich.; CDL:094525-Z) UDmi"ea Dy
00041123 Dow Chemical Company (1964) The Metabolism of Tordon Herbicide bv
the Rat. (Unpublished study received Nov 6, 1967 under OFOSfi?-
CDL:094525-AH) WOBW,
00041125 Dow Chemical Company (1964) A Residue Study on Tissues from
Cattle Fed Diets Containing Tordon Herbicide. (Unpublished
study received Nov 6, 1967 under 0F0863; CDL:094525-AJ)
00041126 Leasure, J.K.; Getzendaner, M.E. (1965) The Determination of Resi
dues of Tordon In Various Tissues from Rabbits. (Unpublished
study received Nov 6, 1967 under 0F0863; submitted by Dow Chemi-
cal U.S.A., Midland, Mich.; CDL:094525-AK)
70
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard For Plcloram
MR ID Citation
00044004 Bovey, R.W.; Burnett, E.; Richardson, C.; et al. (1974) Occurrence
of 2,4,5-T and Plcloram 1n surface runoff water in the Black-
lands of Texas. Journal of Environmental Quality 3(1):61-64.
(Also 1n unpublished submission received May 5, 1975 under 464-
323; submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:
221997-D) "
00044009 Farmer, W.J.; Aochi, Y. (1974) Plcloram sorption by soils. Soil
Science Society of America Proceedings 38:418-423. (Also 1n un-
published submission received May 5, 1975 under 464-323; submit-
ted by Dow Chemical U.S.A., Midland, Mich.; CDL:221997-J)
00044014 Goring, C.A.I.; Youngson, C.R.; Hamaker, J.W. (1966) Residues of
Tordon in Soil from Field Experiments Treated with Tordon and
Sampled at Various Intervals after Treatment. Includes undated
method entitled: Bioassay method for the determination of resi-
dues of Tordon herbicide in soil. (Unpublished study received
CDL 2219975Q)nder 4M"323; subm1tted ^ Dow Chemical U.S.A.;
00044017 Helling, C.S. (1971) Pesticide mobility In soils: II. Applications
of soil thin-layer chromatography. Soil Science Society of
America Proceedings 35:737-748. (Also In unpublished submission
received May 5, 1975 under 464-323; submitted by Dow Chemical
U.S.A., Midland, M1ch.; CDL:221997-S)
00044018 Lutz, J.F.; Byers, G.E.; Sheets, T.J. (1973) The persistence and
movement of Plcloram and 2,4,5-T in soils. Journal of Environ-
mental Quality 2(4):485-488. (Also in unpublished study re-
ceived May 5, 1975 under 464-323; submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL:221997-T)
00044023 Youngson, C.R.; Gantz, G.L.; Gantz, R.L.; et al. (1966) Residues of
Tordon 1n Soil from Fields Treated for Selective Need Control
with Tordon(R) Herbicide. Includes undated method entitled:
Bioassay method for the determination of Residues of Tordon her-
bicide 1n soil. (Unpublished study received May 5, 1975 under
464-323; submitted by Dow Chemical U.S.A., Midland, M1ch.; CDL:
221997-Z)
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 1n cooperation with International Research and
Development Corp., submitted by Dow Chemical U.S.A., Midland,
Mich.; CDL:094500-A)
v
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard For Picloram
MRID Citation
00045366 Bjerke, E.L. (1973) Determination of Residues of Picloram 1n Soil
by Gas Chromatography. Method ACR 73.3 dated May 21, 1973.
(Unpublished study received Jul 3, 1975 under 6F1653; submitted
by Dow Chemical U.S.A., Midland, Mich.; CDL:094500-D)
00045369 Bjerke, E.L.; Ervick, D.K. (1975) A Residue Study of Picloram and
2,4-D 1n 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)
00045372 Kutschinskl, A.H.; Stevenson, G.T. (1967) Residues of Tordon acid
1n Milk from Cows Fed the Herbicide. (Unpublished study Includ-
ing experiment no. 3-1400-5, received Jul 3, 1975 under 6F1653-
submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:094501-F)
00045374 Kutschinski, A.H.; Riley, V. (1967) Residues of Tordon acid 1n 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)
00045376 Bjerke, E.L.; Riley, V.; Bucek, O.C.; et al. (1969) Residues of
Picloram 1n 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 Aucj 4 1969 un-
der 0F0863; CDL:093160-G)
00059416 Scifres, C.J.; Hahn, R.R.; D1az-Colon, J.; et al. (1971) Picloram
persistence in semlarid range!and soils and water. Need Sci-
ence 19(4):381-384. (Also 1n unpublished submission received
Sep 26, 1974 under 464-323; submitted by Dow Chemical U.S.A
Midland, Mich.j CDL:120353-G)
00059425 Youngson, C.R. (1968) Effect of Source and Depth of Water, and
Concentration of 4-Am1no-3,5,6-tr1chlorop1col1nic acid on Rate
of Photodecompositlon by Sunlight. (Unpublished study received
Sep 26, 1974 under 464-323; submitted by Dow Chemical USA
Midland, M1ch.; CDL:120353-P) aiu.i.A.,
00066969 Food and Drug Research Laboratories, Incorporated (1976) Eye Irri-
tation Test 1n Rabbits: Laboratory No. 5185a. (Unpublished
study received Aug 25, 1978 under 3533-58; submitted by Airkem,
Div. of Alrwick Industries, Inc., Carlstadt, N.J.; CDL:235636-C)
IX
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard For Picloram
MRID Citation
00069973 Dow Chemical Company (1964) Determination of Tordon Residues 1n
Water and Blood by Gas Chromatography. Tentative residue de-
termination method ACR 64*6 dated Nov 18, 1964* (Unpublished
study received on unknown date under unknown admin, no.* CDL-
130992-J)
00073921 Higham, J.W. (1973) Cycocel(R): Cycocel Residues in Affined Raw
Sugar (Ewa and Hilo, Hawaii): Report No. C-370. Includes
methods M-369 and M-440. (Unpublished study received Jan 28
1974 under 4G1461; submitted by American Cyanamld Co., Prince-
ton, N.J.; CDL:093894-R)
00073972 Dow Chemical Company (1967) Residue Determination Method: Determi-
So S !0rd~! Ac1d 1n M1lk by Gas Chromatography.
Method ACR67.3 dated Jun 22, 1967. (Unpublished study received
Mar 3, 1970 under 8F0660; CDL:090780-I)
00073974 Dow Chemical Company (1967) Residue Determination Method: Deter-
mination of Residues of Tordon Acid in Bovine Tissues by Gas
Chromatography. Method ACR 67.2 dated Jun 21, 1967. (Unpub-
lished study received Mar 3, 1970 under 8F0660; CDL:090780-K)
00078483 Dow Chemical Company (1967) Residue Determination Method: Determi-
nation of Residues of Tordon(R) Acid in Chicken Eggs and T1s-
/neS Chromatography. Method ACR 67.5 dated Sep 14, 1967.
(Unpublished study received on unknown date under 4E1489: sub-
JlIIS & Montana» ^ Agriculture, Helena, Mont.; CDL:
093949-B) '
00081275 U.S. National Institutes of Health (1978) Bioassay of Picloram for
Possible Carcinogenicity. By National Cancer Institute, Car-
*eth*sda, Md.: NIH. (CAS no. 1918-02-1;
NH-CG-TR-23; DHEWpublication no. NIH 78-823; published
study; CDL:241370-B)
00085060 Interreglonal Research Project Number 4 (1981) Sueur? of Residue
Chemistry Data: [Picloram], (Compilation; unpublished study
received Oct 20, 1981 under 2E2585; CDL:070422-A) '
00096247 Harlch, J. (1964) Tentative of Nlcon-PQ. (Unpublished study re-
ceived Dec 23, 1964 under 8052-1; prepared by Harich Chemical
by Vetan1con Chemical and Drug, Inc., Stowe, Pa.;
CuUZZoolb-D]
00096376 Dow Chemical U.S.A. (19??) Technical Picloram; Manufacturing Proc-
1981dunder^464-320^UCDL:244312-C^Ub,1S'led r'Ce1Ved F6b 10'
73
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard For Picloram
MRID Citation
00098317 Gorzinskl, S.J.; Tollett, J.T.; Burek, J.D.; et al. (1980) Piclo-
ram: Results of a 13-week Toxicity Study 1n B6C3F, Mice.
(Unpublished study received Apr 6, 1982 under 464-320; submitted
by Dow Chemical U.S.A., Midland, M1ch.; CDL:247156-D)
00098321 Nolan, R.J.; Smith, F.A.; Muller, C.J.; et al. (1980) Kinetics of
14C-labeled Picloram 1n 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)
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)
00111415 Youngson, C.; Goring, C. (1967) Decomposition of Tordon Herbicide
by Sunlight 1n Water and Soil. (Unpublished study received Nov
6, 1967 under 8F0660; submitted by Dow Chemical Co., Indian-
apolis, IN; CDL:091158-D)
00111422 Hamaker, J.; Goring, C.; Youngson, C. (1966) Sorption and leaching
of 4-am1no-3,5,6-tr1chlorop1col1n1c acid In soils. Advances In
Chemistry Series (60):23-37. (Also 1n unpublished submission
received Nov 6, 1967 under 8F0660; submitted by Dow Chemical
Co., Indianapolis, IN; CDL:091156-G)
00111436 Merkle, M.; Baur, J.; Bovey, R.; et al. (1968) The fate of herbi-
cides used to control brush. Pages 53-56, In Brush Research 1n
Texas. By ?. [S.I.: s.n.]. (PR-2601; also In unpublished
submission received Apr 4, 1970 under 0F0863; submitted by Dow
Chemical Co., Indianapolis, IN; CDL:091492-P)
00111441 Merkle, M.; Bovey, R.; Davis, F. (1967) Factors affecting the
persistence of picloram 1n soil. Agronomy Journal 59(Sep-Oct):
413-415. (Also in unpublished submission received Apr 4, 1970
under 0F0863; submitted by Dow Chemical Co., Indianapolis, IN;
CDL:091492-V)
00111470 Getzendaner, M.; Herman, J.; Van Glessen, B. (1969) Residues of 4-
am1no-3,5,6-tr1chlorop1collnlc acid in grass from applications
of Tordon herbicides. Agricultural and Food Chemistry 17
(6):1251-1256* (Also In unpublished submission received Sep 26,
1974 under 464-323; submitted by Dow Chemical U.S.A., Midland,
MI; CDL:120318-0)
1H
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard For Picloram
MR ID Citation
00111473 Grover, R. (1971) Adsorption of picloram by soil colloids and
various other adsorbents. Weed Science 19(4):417-418. (Also In
unpublished submission received Sep 26, 1974 under 464-323; sub-
mitted by Dow Chemical U.S.A., Midland, MI; CDL:120318-V)
00111475 Haas, R.; Scifres, C.; Merkle, M.; et al. (1971) Occurrence and
persistence of picloram 1n grassland water sources. Weed Res.
11:54-62. (Also in unpublished submission received Sep 26, 1974
under 464-323; submitted by Dow Chemical U.S.A., Midland, MI;
CDL:120318—X)
00111491 Norris, L. (1969) Herbicides Runoff from Forest Lands Sprayed in
Summer. Research progress rept. dated Feb 10, 1969. (Unpub-
lished study received Sep 26, 1974 under 464-323; prepared by
Western Society of Weed Science, submitted by Dow Chemical
U.S.A., Midland, MI; CDL:120345-L)
00111493 Norris, L. (1971) Herbicide Residues in Soil and Water from Bonne-
ville Power Administration Transmission Line Rights-of-way. (U.
S. Forest Service; unpublished study; CDL:120345-N)
00111494 Norris, L. (1972) Herbicide Residues in Soil, Water, and Vegetation
or Spray Interception Discs, from Bonneville Power Administra-
tion Transmission Line Rights-of-way. (U.S. Forest Service,
Forestry Sciences Laboratory; unpublished study; CDL:120345-0)
00111504 Meikle, R.; Youngson, C.; Hedlund, R.; et al. (1973) Measurement
and prediction of Picloram disappearance rates from soil.
Weed Science 21(6):549-555. (Also in unpublished submission
received Sep 26, 1974 under 464-323; submitted by Dow Chemical
U.S.A., Midland, MI; CDL:120352-H)
00111515 Hedlund, R.; Youngson, C. (1972) The rates of photodecomposltlon of
picloram 1n aqueous systems. Advances In Chemistry Series
(111):159-172. (Also 1n unpublished submission received Sep 26,
1974 under 464-323; submitted by Dow Chemical U.S.A.; Midland,
MI; CDL:120317-E)
00111516 Helling, C. (1971) Pesticide mobility in soils I. Parameters of
thin-layer chromatorgraphy. Soil Science Society of America
Proceedings 35:732-747. (Also in unpublished submission re-
ceived Sep 26, 1974 under 464-323; submitted by Dow Chemical
U.S.A., Midland, MI; CDL:120317-F)
15
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard For Picloram
MRID Citation
00111526 Lutz, J.; Sheets, T. (1971) Movement of Herlcldes off, into, and
through Soils: Contract No. ARS 12-14-100-8938(34). (North
Carolina State Univ., Agricultural Experiment Station, Dept. of
Soil Science, Pesticide Residue Research Laboratory for U.S.
Agricultural Research Service; unpublished study; CDL:120317-S)
i)
00111533 Goring, C.; Youngson, C., Hamaker, J. (1965) Tordon herbicide
... disappearance from soils. Down to Earth 20(4):3-5. (Unpub-
lished study received 1965 under unknown admin, no.; submitted
by Dow Chemical U.S.A., Midland, MI; CDL:122992-A)
00111560 Heitmuller, T. (1975) Acute Toxicity of Tordon 10K Pellets to Lar-
vae of the Easter 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)
00112016 Batchelder, T. (1974) Acute Fish Toxicity of Picloram—(Dry Tordon
Acid). (Unpublished study received Sep 10, 1976 under 464-541;
submitted by Dow Chemical U.S.A., Midland, MI; CDL.-226137-C)
00123282 Carere, A.; Ortali, V.; Cardamone, G.; et al. (1978) Microbio-
logical mutagenicity studies of pesticides In vitro. Mutation
Research 57:277-286. (Also in unpublished submission received
Dec 9, 1982 under 464-502; submitted by Dow Chemical U.S.A.,
Midland, MI; CDL:248984-B)
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)
00128765 MeCarty, L. (1981) Skin Irritation and Skin Sensitization Potential
of Tordon 22K. (Unpublished study received Jun 24, 1983 under
464-502; submitted by Dow Chemical U.S.A., Midland, MI; CDL:
250606-G)
00128947 Bldlack, H. (1980) Determination of the B1©concentration Factor for
Picloram 1n Bluegill Sunflsh 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)
00128948 Bldlack, H. (1980) Kinetics of Aged Picloram 1n a Model Aquatic
Microcosm: GH-C 1370. (Unpublished study received Jun 16,
1983 under 464-502; submitted by Dow Chemical U.S.A., Midland,
MI; CDL:250517-B)
%
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard For Picloram
MRID Citation
00128956 Brady, H. (1973) Picloram and Dlcamba Persistence 1n Forest Envi-
ronments. (Unpublished study received Jun 16, 1983 under 464-
502; prepared by U.S. Forest Service, submitted by Dow Chemical
U.S.A., Midland, MI; CDL:250517-J)
00128957 Byrd, B.; Schwartzbeck, R. (1968) Observations on the Possible
Movement of Tordon Herbicide In Response to Soil or Water Move-
ment: Report GH-P 515. (Unpublished study received Jun 16, 1983
under 464-502; submitted by Dow Chemical U.S.A., Midland, MI;
CDL:250517-K)
00128958 Byrd, B.; Williams, C.; Bjerke, E. (1970) A Study of Potential
Movement of Picloram after Application to Highway and Railroad
Rights-of-way. (Unpublished study received Jun 16, 1983 under
464-502; submitted by Dow Chemical U.S.A., Midland, MI; CDL:
250517-C)
00128963 Fryer, D.; Smith, Pi; Ludwlg, J. (1979) Long-term persistence of
Picloram in a sandy loam soil. J. Environ. Qual. 8(l):83-86.
(Also in unpublished submission received Jun 16, 1983 under
464-502; submitted by Dow Chemical U.S.A., Midland, MI; CDL:
250517-R)
00128976 McCall, P.; Jeffries, T. (1978) Aerobic and Anaerobic Soil Degrada-
tion of l4C-p1cloram. Final rept. (Unpublished study received
Jun 16, 1983 under 464-502; submitted by Dow Chemical U.S.A.,
Midland, MI; CDL:250518-A)
00128977 McCall, P. (1978) Desorption Kinetics of Picloram. (Unpublished
study received Jun 16, 1983 under 464-502; submitted by Dow
Chemical U.S.A., Midland, MI; CDL:250518-B)
00128981 Norrls, L.; Montgomery, M.; Warren, L. (1976) Leaching and Persis-
tence Characteristics of Picloram and 2,4-D on a Small Watershed
1n Southwest Oregon. (Presented at the 1976 Annual Meeting:
Weed Science Society of America; Feb 5, 1976, Denver, CO; unpub-
lished study received Jun 16, 1983 under 464-502; prepared in
cooperation with U.S. Forest Service, Pacific Northwest Forest
and Range Experiment Station and others, submitted by Dow Chemi-
cal U.S.A., Midland. MI; CDL:250518-F)
00128987 Sirons, G.; Frank, R.; Dell, R. (1977) Picloram residues in sprayed
Macdonald-Cartier Freeway right-of-way. Bulletin of Environmen-
tal Contamination & Toxicology 18(5):526-533. (Also 1n unpub-
lished submission received Jun 16, 1983 under 464-502; submitted
by Dow Chemical U.S.A., Midland, MI; CDL-.250518-M)
77
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard For Plcloram
MRID Citation
00129073 Heltmuller, T. (1975) Acute Toxicity of Tordon 22K to Larvae of the
Eastern Oyster (Crassostrea v1rg1n1ca), P1nk Shrimp (Penaeus du-
orarum), and Fiddler Crabs (Uca pugllator). (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.; D111, D. (1982) The Toxicity of Plcloram ... 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 Plcloram Containing Various Amounts
of N"-(3,4,5,6-Tetrachloro-2-pyr1d1nyl) Guan1d1ne to Blueglll.
(Unpublished study received Jun 24, 1983 under 464-502* submit-
ted by Dow Chemical U.S.A., Midland, MI; CDL:250605-Q)'
00115034 Sullivan, E. (1971) Determination of Migration of NC-8438 Compared
to Atrazlne: Experiment No. 15. (Unpublished study received Apr
12, 1974 under 10065-EX-4; prepared by Great Western Sugar Co.,
submitted by Flsons Corp., Agricultural Chemicals D1v.. Bedford
MA; CDL:127693-V)
GSO144-012 Johnson, W.; Flnley, M. (1980) Handbook of Acute Toxicity of
Chemicals to fish and Aquatic Invertebrates. USDI Publication
137, Washington, D.C.
7s
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Picloram Standard
GS0096-001 Hamaker, J.W. 1976. The Hydrolysis of Picloram in Buffered,
Distilled Water. GS-1460. Dow Chemical Company Agr. Prods.
Dept., Walnut Creek, California.
GS0096-002 Gibson, J.W. and O.H. Hammer. 1969. Results of Studies on
the Occurrence of Picloram in Water and Soil Following the
use of Various Products Cont4ining Picloram to Control Weeds
and Brush on Texas Rangelands. Ag. Prod. Dept. The Dow
Chemical Company.
GS0096-003 Warren, L.E. 1968. Hie Presence of TORDON in Run-Off Water.
Bioproducts Department, The Dow Chemical Company.
GS0096-004 Green, L.R. and J.R. Goodin. 1972. Buntista Canyon
Waterstudy Study. Letter and data sheets.
GS0096-005 Dow chemical Co. Toxicological Research Laboratory, May 23,
1968.
GS0096-006 Gabriel, K.L. and Benjamin A. Gross. 1964. Repeated Insult
Patch Test Study with the Dow Chemical Company TORDON 101,
November 16, 1964.
GS0096-007 Alexander, H.C. and T.L. Batchelder. 1966. Acute Fish
Toxicity of Daxtron, TORDON, and DURSBAN to Three Species of
Fish. Waste Control Department. The Dow Chemical Company,
Midland, Michigan.
GS0096-008 McCarty, W.M. 1977. Toxicity of 4-Amino-3,5,6-Trichloropicolinic
Acid, Picloram, to Daphnids. Environmental sciences Research,
The Dow Chemical Company, Midland, Michigan.
77
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Appendix iI-3
OMB Approval No. 2000-0468
ppr
f
|EPA REGISTRATION NO.
FIFRA SECTION 3(C)(2)(B) SUMMARY SHEET
PRODUCT NAME
APPLICANT'S NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "generic" data imposed by the FIFRA section 3(C)(2)(B) notice contained in the referenced
Guidance Document, I am responding in the following manner:
~ 1. I will submit data in a timely manner to satisfy the following requirements. If the test procedures I will use deviate from (or ere not
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group, OECD
Chemicals Testing Programme, I enclose the protocols that I will use:
~ 2. I have entered into an agreement with one or more other registrants under FIFRA section 3(C)(2)(B)(ii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
~ 3. I enclose a completed "Certification of Attempt to Enter Into en Agreement with Other Registrants for Development of Deta" with
respect to the following data requirements:
~ 4. I request that you amend my registration by deleting the followinq uses (this option is not available to applicents for new products):
~ 5. I request voluntary cancellation of the registration of this product (This option is not available to applicents for new products.)
REGISTRANT'S AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
EPA Form 8580-1 (10-82)
S©
-------
Appendix IX-U
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
(To qualify, certify ALL four items) FOR 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)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
NAME OF FIRM
EPA COMPANY NUMBER
(This firm or group of firms ii referred to below as "my firm".)
2. Mv firm is willing to develop and submit the data as required by that Notice, If necessary. 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:
My firm has offend in writing to enter into such an agmmint Copies of tin off en an attached. That offer was irrevocable and included an offer to be
bound by an arbitration derM"1 under FIFRA Section 3(c)(2)(B)(iii) If final agreement on all tarmi could not be reached otherwise. This offer was made
to the following firm(s) on the following date(s):
However, none of those firm(s) accented mv offer,
NAME OF FIRM
DATE OF OFFER
4. My firm requests that EPA not suspend the regirtratlon(i) of my firm's product(s), if any of the firms named in paragraph (3) above
have agreed to submit the data lifted in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
me whether my firm must submit data to avoid suspension of its regittration(s) under FIFRA Section 3(c)(2)(B). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
SIGNATURE
DATE
¦*r
CM tani MM (10-12)
-------
Appendix £1-3
FIFRA SECTION 3(C)(2)(B) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAME
APPLICANT'S NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "generic" data imposed by the FIFRA section 3(C)(2)(B) notice contained in the referenced
Guidance Document, I am responding in the following manner:
~ 1. I will submit data in a timely manner to atisfy the following requirements. If the test procedure* I will use deviate from (or are not
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group, OECO
Chemicals Tasting Programme, I enclose the protocols that I will use:
G 2. I have entered into an agreement with one or more other registrants under FIFRA section 3(C)(2)(B)(ii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
~ 3. I enclose a completed "Certification of Attempt to Enter Into en Agreement with Other Registrants for Development of Oeta" with
respect to the following data requirements:
D 4. I request that you emend my registration by deleting the following uses (this option is not available to applicants for new products):
~ 5. I request voluntary cancellation of the registration of this product (This option is not available to applicants for new products.)
REGISTRANT'S AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
EPA Form 8580-1 (10-82)
m
-------
Jtooendix III-l (continued)
1
1
1
1
1
Registration ]
Guideline No. j Name of Test
Test not
required
for my
product
listed
above
(check
belcw)
1
I am complying with 1
data requirements by I
Citing MRID#
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
63-13 1 Stability
63-14 1 Oxidizing/reducing
i reaction
63-15 1 Flammatuiity
63-16 1 Explodability
63-17 1 Storage stability
63-18 1 Viscosity
63-19 1 Miscibility
63-20 I Corrosion
I characteristics
63-21 1 Dielectric break-
j down voltage
S15ft.135 1
TOXICDDDGY 1
81-1 1 Acute oral D>50,
I rat
81-2 1 Acute dermal
1 ID-50
j
81-3 1 Acute inhalation,
I LC-50 rat
81-4 1 Primary eye
1 irritation, rabbit
i
j
81-5 I Primary dermal
1 irritation
!
81-6 I Dermal sensitiza- 1 1
j tion 1 1
%2>
-------
Appendix IV-1
Chapter I—Environmental Protection Agency
§ 162.10
cafct obtained the data from anothc
fir*i (identify); applicant copied dajfa
froti a publication; applicant obtained
a cofcy of the data from EPA).
(d»The applicant shall submit j^th
his application a statement that aPA,
in its ^valuation of the properties/effi-
cacy, and safety of the formulated
end-usAproduct. may not consi6it any
data aA supporting the application,
except tie following data:
(1) Th\ data the applicant fcas sub-
mitted toYEPA under paragraph (b) of
this sectii
(2) Oth
safety of tl
ents, rathe:
end-use pn
(3) Existini
regulations,
data pertain:
|e product's act:
Uhan to the
,ict; and
L tolerances,
Exemptions,
to the
ingredi-
Jety of the
d additive
and other
the Federal
: Act.
lows that any
Eted under this
by (or at the ex-
on who original-
to EPA (or its
(fc If the applicant's product /on-
tail* any active ingredient other /han
thosk that are present solely because
of theUncorporation into the pjffcduct,,
during\formulation, of one y more
other Mgistered pesticide products
purchased from another /roducer.
then the\applicant shall also comply
with S 162JB-5 as to such ytive ingre-
dient, and \he applicatio/ shall con-
tain an acknowledgment /hat for pur-
poses of FIFTtA section/(c)(l)(D) the
application reles on (and any result-
ing registratioi\shoul7 be regarded as
clearances issaed undef
Food, Drug, an® Cosmet,
(e) If the applicant
item of data hnsubt
section was generated]
pense of) anotheApei;
ly submitted the
predecessor, USDA)/on or after Janu-
ary 1, 1970, to supfort an application
for registration, /experimental, • use
permit, or amendment adding a new
use to an existin/ registration, or for
reregLstration (utiles* the applicant
and the original data\submitter have
reached writte/ agreement on the
amount and ttw terms VDf payment of
any compensation than may be pay-
able under FIFI\A section
3(c)(lXDXii)Airlth regard to approval
of the application), the applicant shall
submit to KPA a statement that he
has furnished to each sue* identified
original dua submitter:
(1>A unification of the Applicant's
intent to Apply for registration, includ-
ing the of oposed product
(2) Anf offer to pay the perftpn com-
pensation, with regard to the approval
of the/application, to the extent re-
quires by FIFRA sections 3 of this section;
Vf
-------
§ 162.10
(iv) The product registration
number as prescribed in paragraph (e)
of this section;
(v) The producing establishment
number as prescribed in paragraph (f)
of this section;
(vi) An ingredient statement as pre-
scribed in paragraph (g) of this
section;
(vii) Warning or precautionary state-
ments as prescribed in paragraph (h)
of this section;
(viii) The directions for use as pre-
scribed in paragraph (i) of this section;
and
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 indi-
rectly implying that the pesticide or
device is recommended or endorsed by
-------
Chapter I—Environmental Protection Agency
§ 162.10
any agency of the Federal Govern-
ment:
(vi) The name of a pesticide which
contains two or more principal active
ingredients if the name suggests one
or more but not all such principal
active ingredients even though the
names of the other ingredients are
stated elsewhere in the labeling;
(vii) A true statement used in such a
way as to give a false or misleading im-
pression to the purchaser;
(viii) Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions;
(ix) Claims as to the safety of the
pesticide or its ingredients, including
statements such as "safe," "nonpoison-
ous," "noninjurious," "harmless" or
"nontoxic to humans and pets" with
or without su$h a qualifying phrase as
"when used as directed"; and
(x) Non-numerical and/or compara-
tive statements on the safety of the
product, including but not limited to:
(A) "Contains all natural Ingredi-
ents":
-------
§ 162.10
allel to it. The registration number
and the required identifying phrase
shall not appear in such a manner as
to suggest or imply recommendation
or endorsement of the product by the
Agency.
(f) Producing establishments regis-
tration number. The producing estab-
lishment registration number preced-
ed by the phrase "EPA Est.", of the
final establishment at which the prod-
uct was produced may appear in any
suitable location on the label or imme-
diate container. It must appear on the
wrapper or outside container of the
package if the EPA establishment reg-
istration number on the immediate
container cannot be clearly read
through such wrapper or container.
(g) Ingredient statement—i 1) Gener-
al The label of each pesticide product
must bear a statement which contains
the name and percentage by weight of
each active ingredient, the total per-
centage by weight of all inert ingredi-
ents; and if the pesticide contains ar-
senic in any form, a statement of the
percentages of total and water-soluble
arsenic calculated as elemental ar-
senic. The active ingredients must be
designated by the term "active ingredi-
ents" and the inert ingredients by the
term "inert Ingredients," or the singu-
lar forms of these terms when appro-
priate. Both terms shall be in the
same type size, be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" is
not required for pesticides which eon-
tain 100 percent active ingredients.
Unless the Ingredient statement is a
complete analysis of the pesticide, the
term "analysis" shall not be used as a
heading for the ingredient statement.
(2) Position of ingredient statement
(1) The ingredient statement is nor-
mally required on the front panel of
the label. If there is an outside con-
tainer or wrapper through which the
ingredient statement cannot be clearly
read, the ingredient statement must
also appear on such outside container
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.
Title 40—Protection of Environment
(ii) The text of the ingredient state-
ment must run parallel with other
text on the panel on which it appears,
and must be clearly distinguishable
from and must not be placed in the
body of other text.
(3) Names to be used in ingredient
statement The name used for each in-
gredient shall be the accepted
common name, if there is one. fol-
lowed by the chemical name. The
common name may be used alone only
if it is well known. If no common name
has been established, the chemical
name alone shall be used. In no case
will the use of a trademark or propri-
etary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of Section 25(c)(6).
(4) Statements of percentages. The
percentages of ingredients shall be
stated in terms of weight-to-weight.
The sum of percentages of the active
and the inert ingredients shall be 100.
Percentages shall not be expressed by
a.range of values such as "22-25%." If
the uses of the pesticide product are
expressed as weight of active ingredi-
ent per unit area, a statement of the
weight of active Ingredient per unit
volume of the pesticide formulation
shall also appear in the ingredient
statement
(5) Accuracy of stated percentages.
The percentages given shall be as pre-
cise as possible reflecting good manu-
facturing practice. If there may be un-
avoidable variation between manufac-
turing batches, the value stated for
each active ingredient shall be the
lowest percentage which may be
present.
(«) Deterioration. Pesticides which
change in chemical composition sig-
nificantly must meet the following la-
beling requirements:
(i) In cases where it is determined
that a pesticide formulation changes
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 indi-
cated on the label.
(?) Inert ingredients. The Adminis-
trator may require the name of any
*7
-------
Chapter I—Environmental Protection Agency
§ 162.10
inert ingredi'ent(s) to be listed in the
ingredient statement if he determines
that such ingredients) 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 require-
ments concerning content, placement,
type size, and prominence are given
below.
(1) Required front panel statements.
With the exception of the child
hazard warning statement, the text re-
quired on the front panel of the label
is determined by the Toxicity Catego-
ry of the pesticide. The category is as-
signed on the basis of the highest
hazard shown by any of the indicators
in the table below:
Hazard tadteaior*
Toncnyc
nagoria*
I i «
III
IV
Oral ID-
inhataten UC>»—
Oarmal LD»
Ey* aflact*
Skin (fleet* -
—
Up to and mduding SO
mg/kg
Up to and wWH -2
mg/War.
Up to and including 200
mg/kg.
Corroawa: comaai
opacity no< rfrUM
wttwi 7 day*.
CorroaM
From SO thru 500 mg/kg..
From 2 thru 2 mg/War
From 200 fcni 2000
ComMi opacity
ravaratta MNn 7
day*; irritation
paraMng tor 7 day*.
Savara MaMn at 72
hours.
From 500 thru 5000 mg/
From 2. ffifti 2C mg/lttar...
From 3.000 thru 20.000....
No comaai opacity,
mttton rawaraibla.
within 7 day*.
Modarata mutton at 72
hour*.
Graatar than SO00 mg/
•*a
6rwthan 20 mg/Mar.
Graatar than 20,000.
No imttfeen.
MUd or aiigM mutton at
72 hour*.
(i) Human hazard signal word—(.A)
Toxicity Category I. All pesticide prod-
ucts meeting the criteria of Tonicity
Category I shall bear on the front
panel the signal word "Danger." In ad-
dition if the product was assigned to
Toxicity Category I on the basis of .its
oral, inhalation or dermal toxicity (as
distinct from skin and eye local ef-
fects) the word "Poison" shall appear
in red on a background of distinctly
contrasting color and the skull and
erocsbones shall appear in immediate
proximity to the word "poison.
(B) Toxicity Category II. All pesti-
cide products meeting the criteria of
Toxicity Category II shall bear on the
front panel the signal word "Warn-
ing."
(C) Toxicity Category III All peati-
cide products meeting the criteria of
Toxicity Category 111 shall bear on
the front panel the signal word "Cau-
tion."
Child hazard warning. Every pes-
ticide product label shall bear on the
front panel the statement "keep out of
reach of children." Only in cases
where the likelihood of contact with
children during distribution, market-
ing, storage or use is demonstrated by
the applicant.to be extremely remote,
or if the nature of the pesticide is such
that it is approved for use on infants
or small children, may the Administra-
tor waive this requirement.
(iii) Statement of practical treat-
ment—
-------
§ 162.10
placement of the statement of practi-
cal treatment is some reference such
as "See statement of practical treat-
ment on back panel" appears on the
front panel near the word "Poison"
and the skull and crossbones.
(B) Other toxicity categories. The
statement of practical treatment is not
required on the front panel except as
described in paragraph (hXIXttiXA) of
this section. The applicant may, how-
ever, include such a front panel state-
ment at his option. Statements of
practical treatment are. however, re-
quired elsewhere on the label in
accord with paragraph (hX2) of this
section if they do not appear on the
front panel.
(iv) Placement and prominence. All
the require front panel warning state-
ments shall be grouped together on
the label, and shall appear with suffi-
cient prominence relative to other
front panel text and graphic material
to make them unlikely to be over-
looked under customary conditions of
purchase and use. The following table
shows the minimum type size require-
ments for the front panel warning
statements on various sizes of labels:
Title 40—Protection of Environment
Potms
Sat Of front pana< ir\ touart
inchfs
*9**1
wo. an
capita*
out
raacn o'
ChiiO'en
S and iffdar
S !
6
Abort » to 10
10
6
Abova tO to IS —
12 !
8
Abova IS le 30
14 !
10
Ow 30
ie 1
i
12
(2) Other required warnings and pre-
cautionary statements. The warnings
and precautionary statements as re-
quired below shall appear together on
the label under the general heading
"Precautionary Statements" and
under appropriate subheadings of
"Hazard to Humans and Domestic Ani-
mals," "Environmental Hazard" and
"Physical or Chemical Hazard."
(i) Hazard to humans and domestic
animals. (A) Where a hazard exists to
humans or domestic animals, precau-
tionary statements are required indi-
cating the particular hazard, the
route(s) of exposure and the precau-
tions to be taken to avoid accident,
injury or damage. The precautionary
paragraph shall be immediately pre-
ceded by the appropriate hazard signal
word.
(B) The following table depicts typi-
cal precautionary statements. These
statements must be modified or ex-
panded to reflect specific hazards.
Toxicity
etlagory
Pracaukpnary ttaMmantt by tomcrty category
Oral. inhalation. or darmaTtoactty
Skin and aya local aflacta
ratal (pciaonoua) » mmteima (rttaiad or abaorttad
through akin]. Do not oraatha vapor (dual or tpray
mat). Do not pat m ayaa, on atun. or on (Hotting
(Front panat atatantant ot praettsal traatmant «•-
May M mat W awaitowad twmad or aMortM
tnraugh tw aunl. Do not btaotha vapor* Mm or
•pray miaO. Do not gat rt ayaa. on Mn. or on
eletMtg. tApprepnata drat aid ataiamanw raw*od.l.
twrrii ii vanniB ivvwiq ot mofBco vvwj"
•Mn]. Avoid Matting vapor* (dual or apray MM].
Avoid contact with akin (ayaa or ctodvngj- I Appro-
pnoia *r*t aid atatamant raqurad.].
(No prtaauaenary atatamanta randan T
Conaawa, eauaaa aya and akin damaga Cor aiun
MtMonl. Do net gat ft ayaa. an Hun. or on
atoM*. Waar goggtaa or
-------
§ 162.10
placement of the statement of practi-
cal treatment is some reference such
as "See statement of practical treat-
ment on back panel" appears on the
front panel near the word "Poison"
and the skull and crossbones.
(B) Other toxicity categories. The
statement of practical treatment: is not
required on the front panel except as
described in paragraph (h)UXiilKA) of
this section. The applicant mayi how-
ever, include such a front panel I state-
ment at his option. Statements of
practical treatment are. however, re-
quired elsewhere on the lafcjel in
accord with paragraph (h)(2) off this
section if they do not appear an the
front panel.
(iv) Placement and prominence. All
the require front panel warning state-
ments shall be grouped together on
the label, and shall appear with! suffi-
cient prominence relative to other
front panel text and graphic material
to make them unlikely to be over-
looked under customary conditions of
purchase and use. The following! table
shows the minimum type size require-
ments for the front panel warning
statements on various sizes of labels:
Title 40—Protection of Environment
Poinw
Sin of l«Mi front pan« m iquar*
ineha*
Rtqwrrt ,
kmc out
word. iH ; 01
eaMai® ChilOMn
Sandmdar..
a&om a m to...
10 1 6
12 i 1
1« 10
1« 12
Abov* 10 to 19
Ataw* 18 to M
Owr ao
(2) Other required learnings and pre-
cautionary statements. The warnings
and precautionary statements as re-
quiredbelow shall appear together on
the label under the general heading
"Precautionary Statements" and
under appropriate subheadings of
"Hazard to Humans and Domestic Ani-
mals." "Environmental Hazard" and
"Physical or Chemical Hazard."
(i) Hazard to humans and domestic
animals. (A) Where a hazard exists to
humans or domestic animals, precau-
tionary statements are required indi-
cating the particular hazard, the
route(s) of exposure and the precau-
tions to be taken to avoid accident.
Injury or damage. The precautionary
paragraph shall be immediately pre-
ceded by the appropriate hazard signal
word.
(B) The following table depicts typi-
cal precautionary statements. These
statements must be modified or ex-
pended to reflect specific hazards.
ToMMy
Fr4eu*9»*y iweiwiis bv Wo*y owgery
&ai« Mutation, or dOHnoTHMiolly
I
1
1
I
s
' ¦
¦
¦
NM (poaonom) V turn (fcM
though Mnl. Oo not broatho vo«
not]. Oo not got to ayaa. an M
thm pan# mmm ot not
qMrod.}.
Mar M MM « PII—B'H ¦» (MM
awougn tiw Mnl Oo not bumi
mn ntiaU. Oo not got M
hwwm J HHWI id flntiotod 9 em
Mnl. Avow BraaHng mow Mm
AnW eontMl wMt (Mn Coyaa or c
anata tut m wtowiow
M or ibwitH
* Cdual or way
i or an acting
at no—mm r*.
¦0 or MaeitM
-------
Chapter I—Environmental Protection A
stances under which they are required
follow:
(A) If a pesticide intended for out-
door use contains an active ingredient
with a mammalian acute oral LD» of
100 or less, the statement "This Pesti-
cide is Toxic to Wildlife" is required.
(B) If a pesticide intended for out*
door use contains an active Ingredient
with a fish acute LCM of 1 ppm or less,
the statement "This Pesticide is Toxic
to Fish" is required.
(C) If * pesticide intended for out*
door use contains an active ingredient
with an avian acute oral LD» of 100
mg/kg or less, or a subacute dietary
LCm of 500 ppm or less, the statement
"This Pesticide is Toxic to Wildlife" is
required.
ncy § 162.10
pesticide may result in fatality to
birds, fish or mammals, the statement
"This pesticide is extremely toxic to
wildlife (fish)" is required.
(X) For uses involving foliar applica-
tion to agricultural crops, forests, or
shade trees, or for mosquito abate-
ment treatments, pesticides toxic to
pollinating insects must bear appropri-
ate label cautions.
(F) For all outdoor uses other than
aquatic applications the label must
bear the caution "Keep out of lakes,
ponds or streams. Do not contaminate
water by cleaning of equipment or dis-
posal of wastes."
(ill) Physical or chemical haaarda.
Warning statements on the flammabil-
ity or explosive characteristics of the
pesticide are required as follows:
(A) Mm
any vaM opamng.
Plaan port HM«t ao*' P and net ow W P or if M
lima " is im Mn it in long it a amnea
of 4 in from ma Rama.
fcoramely SammsMi. Cantana undar passu*. Karp May kam
Ira. *j*isatDa Mipimua^ar Mnarata
avaang.
n«mwaMi Csmami undar prawa Kaap mm *am haak
ipwf. and opanHama. 0a net punsM* arwsxamia asmswsi.
beaaws to tsinpsrafeMa now 1CT P may saass bwalna
Camams undar smsauw, 0a not uaa sr sum nsar nasi sr span
lama. Oa not puwura sr Mmnm sammr. bpaaua The Administrator determines
that it Is not necessary for such direc-
tions to appear on the label.
(Ill) Exception* to requirement for
Unction for km—(A) Detailed direc-
tions for use may be omitted from la-
beling of pesticides which are intended
Tt
-------
§ 162.10
for use only by manufacturers of prod-
ucts other than pesticide products in
their regular manufacturing 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.
(2) Adequate information such as
technical data sheets or bulletins. Is
available to the trade specifying the
type of product involved and its
proper use in manufacturing process*
es;
(J) The product will not come into
the hands of the general public except
after incorporation into finished prod*
ucts; and
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment
The product is also a drug and
regulated under the provisions of the
Federal Food, Drug and Cosmetic Act.
(C) Detailed directions for use amy
be omitted tram the labeling of pesti-
cide products which are intended for
use only by formulators in preparing
pesticides for sale to the public, pro-
vided that:
(I) 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
oestlcide ouraoses:
(i) The label clearly state* that the
product is intended for use only in
manufacturing, formulating, mixing,
or repacking for use as a pesticide and
specifies the type(s> of pesticide prod-
ucts involved;
<1) The product as finally manufac-
tured, formulated, mixed, or repack-
aged is registered; and
Title 40—Protection of Environment
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(2) Contents of Directions for Use.
The directions for use shall include
the following, under the headings "Di-
rections for Use":
(I) The statement of use classifica-
tion as prescribed in 162.l0(j) immedi-
ately under the heading "Directions
for Use."
(II) Immediately below the state-
ment of use classification, the state-
ment "Xt is a violation of Federal law
to use this product in a manner incon-
sistent with its labeling."
(III) The slte(a) of application, as for
example the crops, animals, areas, or
objects to be treated.
Uv> The target pest(s) associated
with each site.
(v) The dosage rate associated with
each site and pest.
(vl) The method of application, in-
cluding instructions for dilution. If re-
quired, and type.)
(x) Any limitations or restrictions on
use required to prevent unreasonable
advene effects, such as:
(A) Required intervals between ap-
plication 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.
[Reserved]
U
-------
Chapter I—Environmental Protection Agency
§ 162.11
(E) For restricted use pesticides, a
statement that the pesticide may be
applied under the direct supervision of
a certified Applicator who is not phys-
ically present at the site of application
but nonetheless available to the
person applying the pesticide, unless
the A«ency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who is physically present.
CP) 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 22,1 ¥16, all pesticide prod-
ucts must bear on their labels a state-
ment of use classification as described
in paragraphs (JX1> and (2) of this
section. Any pesticide product for
which some uses are classified for gen-
eral use and others for restricted use
shall be separately labeled according
to the labeling standards set forth in
this subsection, and shall be marketed
as separate products with different
registration numbers, one bearing di-
rections only for general usees) and
the other bearing directions for re-
stricted used) except that, if a product
has both restricted use11 Criteria for determinations of an-j
»nabl« advene effects.
(a)\riteria for Issuance of Notic&of
Intent\o Deny Registration, Cancel
Registration, or to Mold a Healing—
(1) Preemption. (I) A rebuttable pre-
sumption ahall arise that a notice of
intent to dour registration pursuant to
section 3? registration pursuant
to section HbJhl) of tJre Act, or a
notice of intent V hobf a hearing to
determine wjiethlr Jbe registration
should be eaneeUea/r denied, as ap-
propriate, shall beyOsued, upon a de-
termination by thr Administrator that
the pesticide m«fts or Vcceeds any of
the criteria fomisk set Jorth in para-
graph of this section. The apift
it or registrant shall have forty-fivi
-------
APPENDIX IV-2
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
rnsM
LABEL ELEMENT
APPLICABILITY
OF REQUIREMENT
PLACEMENT ON LABEL
COWENTS
REQUIRED
PREFERRED
1
Product name
All products
Front panel
Center front
panel
2
Ocn^pany name
and address
All products
None
Bottom front
panel or end
of label text
If registrant is not the producer, must
be qualified by "Packed for . . .
"Distributed by. . etc.
3
Net contents
All products
None
Bottom front
panel or end
of label text
May be in metric units in addition to
U.S. units
4
EPA Reg. No.
All products
None
Front panel
Must be in similar type size and run
parallel to other type.
5
EPA Est. No.
All products
None
Front panel,
immediately
before or
following
Reg. No.
May appear on the container instead of
the label.
6A
Ingredients
statement
All products
Front panel
Immediately
following
product name
Text must run parallel with other text
on the panel.
6B
Pounds/gallon
statement
Liquid products
where dosage
given as lbs.
ai/unit area
Front panel
Directly below
the main
ingredients
statement
7
Front panel
precautionary
statements
All products
Front panel
All front panel precautionary statements
must be grouped together, preferably
blocked.
7A
Keep Out of Reach
of Children
(Child hazard
warning)
All products
Front panel
Above signal
word
Note type size requirements.
7B
Signal word
All products
Front panel
Immediately
below child
hazard
warning
Note type size requirements.
•n
-------
APPENDIX IV-2 (continued)
ITEM
LABEL ELEMENT
APPLICABILITY
OF REQUIREMENT
PLACEMENT
required
ON LABEL
PREFERRED
COMBOS
7C
Skull & cross-
bones and word
POISON (in red)
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
Front panel
Both in close
proximity to
signal word
7D
Statement of
practical
treatment
All products
in Categories
I, II, and III
Category 1:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel
for all.
7E
Referral
statement
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
Front panel
8
Side/back panel
precautionary
statements
All products
None
Top or side
of back panel
preceding
directions
for use
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
8A
Hazards to
bunans and
domestic
animals
All products
in Categories
I, II, and III
None
Same as above
Must be preceded by appropriate signal
word.
8B
Environmental
hazards
All products
None
Same as above
Environmental hazards include bee
caution where applicable.
15
-------
APPENDIX IV-2 (continued)
APPLICABILITY
PLACEMENT OK LABEL
ITEM
LABEL ELEMENT
OP REQUIREMENT
REQUIRED
PREFERRED
COMMENTS
8C
Physical or
chemical
hazards
All pressurized
products, others
with flash
points under
150°F
None
Seme as above
9A
Restricted
block
All restricted
products
Top center
of front
panel
Preferably
blocked
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be sane type size as
signal word.
9C
Misuse
statement
All products
Immediately
following
heading of
directions
for use
10A
Reentry
statement
All
cholinesterase
inhibitors
In the
directions
for use
Immediately
after misuse
statement
IOC
Storage and
disposal block
All products
In the
directions
for use
Immediately
before
specific
directions
for use or
at the end of
directions
for use
Must be set apart and clearly distin-
guishable frcm fran other directions
for use.
100
Directions
for use
All products
None
None
Hay be in metric as well as U.S. units
-------
Appendix IV-3
Criteria
PHYSICAL-CHEMICAL HAZARDS
Required Label Statement
I. Pressurized Containers
A.
Flashpoint at or below
20°P: or if there is a
flashback at any valve
ODeninq.
B,
Flashpoint above 20°F
and not over 80°F: or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
ALL OTHER PRESSURIZED
CONTAINERS
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 8n°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 13f)°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.
ii
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Appendix IV-4
STORAGE AND DISPOSAL INSTRUCTIONS FOR PESTICIDES
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." The STORAGE AND DISPOSAL heading
muslt appear in the minimum type size listed below:
1
ISIJ
Ifr
1 sq
ze of label
ont panel in
uare inches
I Required type size I
I for the heading j
1 STORAGE AND DISPOSAL j
1 (all capitals) 1
1
110
(Ab
1 Ab
I Ov
1
and under ......
ove 3 5 to 30
1
1
Stolrage and disposal instructions must be set apart and
clearly distinguishable from other directions for use.
Blocking storage and disposal statements with a solid line is
suggested as a means of increasina their prominence.
A. Storage Instructions?
All ptoduct labels are required to have appropriate storaqe
instructions. Specific storage instructions are not prescribed.
Eac^i 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 storaqe area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
12
-------
Append ix IV-4
(continued)
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 pestipides •
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.
B. 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 wordinq
that must appear on the label of these products: 1
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
appearing on the "Acutely Hazardous" Commercial Pesticide
Products List (RCRA "E" List) at the end of this appendix
or are assigned to Toxicity Category I on the basis of
oral or dermal toxicity, skin or eye irritation potential,
or Toxicity Category I or II on the basis of acute inhala-
tion toxicity must bear the following pesticide disposal
statement:
"Pesticide wastes are acutely hazardous. Improper dis-
posal 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."
The labels of all products, except those intended for
domestic use, containing active or inert ingredients
that appear on the "Toxic" Commercial Pesticide Products
List (RCRA "F" List) at the end of this appendix or
presently meet any of the criteria in Subpart C, 40 CFR
261 for a hazardous waste must bear the following pesticide
disposal statement:
-------
Appendix IV-4
(continued)
"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."
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."
3. 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."
C. Container Disposal Instructions
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. All products intended for domestic use must bear one
of the following container disposal statements:
Container
TYPe
tol pi
I Non-aerosol products
I(bottles, cans, jars)
I Non-aerosol products
I(bags)
I Aerosol products
I
Statement
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.
ico
-------
Appendix IV-
(continued)
4
2. The labels for all other products must bear container disposal
instructions, based on container type, listed below:
Container Type
Metal
containers
(non-aerosol)
Statement
Triple rinse (or equivalent). Then offer
for recycling or reconditioninq, or puncture
and dispose of in a sanitary landfili, or by
other procedures approved by state and local
authorities.
Plastic containers
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
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.
Glass containers
Fiber drums
with liners
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
reused1, dispose of in the same manner.
Paper and
plastic bags
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 burninq. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wording)
Compressed qas
cylinders
V Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
I0(
-------
Appendix IV-4
(continued)
Pesticides that are hazardous wastes under 40 CFR 261.33(e) and (f)
when discarded.
"Acutely Hazardous*' Commercial Pesticides (RCRA "E" List)
Active Ingredientsy (no inertsT: ——
Acrolein
Aldicarb
Aldrin
Allyl alcohol
Aluminum phosphide
4-Aminopyridine
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p-Chloroaniline
Cvanides (soluble cyanide salts, not specified elSewere)
Cyanogen chloride
2-Cyclohexyl-4,6-dinitrophenol
Dieldrin
0,0-Diethyl S-f2-ethylthio)ethylJ phosphorodithioate
(disulfoton, Di-Syston)
0,0-Diethyl 0-pyrazinyl phosphorothioate (Zinophos)
Dimethoate
0,0-Dimethyl 0-p-nitrophenyl phosDhorothioate (methyl parathion)
4,6-Dinitro-o-cresol and salts
4,6-Dinitro-o-cyclohexylphenol
2,4 Dinitrophenol
Dinoseb
Endosulfan
Endothall
Endrin
Famphur
PIuoroacetamide
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methomyl
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA, schradan)
Parathion
104.
-------
Appendix IV-4
(continued)
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients continued:
Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
Strychnine and salts
0,0,0,0-Tetraethyl dithiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate
Thallium sulfate
Thiofanox
Toxaphene
Warfarin
Zinc phosphide
103
-------
Append ix IV-4
(continued)
"Toxic" Commercial Pesticide Products (RCRA "P" List)
" Active Ingredients:
Acetone
Acrylonitrile
Amitrole
Benzene
Bis(2-ethylhexyl)othalate
Cacodylic acid
Carbon tetrachloride
Chloral (hydrate)
Chlordane (technical)
Chlorobenzene
4-Chloro-m-cresol
Chloroform
o-Chlorophenol
,4-Chloro-o-toluidine hydrochloride
Creosote
Cresylic acid
Cyclohexane
Decachlorooctahydro-l,3,4-metheno-2H-cyclobuta[c,d)-pentblen-2-one
(kepone, chlordecone)
1,2-Dib::omo-3-chloropropane (DBCP)
Dibutyl phthalate
5-3,3-(])ichloroallyl diisopropylthiocarbamate (diallate, Avadex)
o-Dichlorobenzene
p-Dichlorobenzene
Dichlorodifluoromethane (Preon 12*)
3,5-Dichloro-N-(1,1-d iraethy1-2-propyny1) benzamide (prohamide,Ker b)
Dichlord diphenyl dichloroethane (DDD)
Dichloro diphenyl trichloroethane (DDT)
Dichlorethyl ether
2,4-Dichlorophenoxyacetic, esters and salts (2,4-D)
1.2-Dic|iloropropane
1.3-Dicnloroprooane (Telone)
Dimethy phthalate
Ethyl acetate
Ethyl 4L 4'-dichlorobenzilate (chlorobenzilate)
Ethylene dibromide (EDB)
Ethylene dichloride
Ethylene oxide
Pormaldlehyde
Furfural
Hexachlorobenzene
Hexachlorocyclopentad iene
Hexachloroethane
Hydrofluoric acid
104
-------
ApDendix IV-4
(continued)
"Toxic* Commercial Pesticide Products (RCRA "F" List)
Active Ingredientst
Isobutyl alcohol
Lead acetate
Lindane
Naleic hydrazide
Mercury
Methyl alcohol
Methyl bromide
Methyl chloride
2,2'-Methylenebis (3,4,6-trichlorophenol) (hexachlorophene)
Methylene chloride
Methyl ethyl ketone
4-Methyl-2-pentanone (methyl isobutyl ketone)
Naphthalene
Nitrobenzene
p-Nitrophenol
Pentachloroethane
Pentachloronitrobenzene (PCNB)
Pentaclorophenol
Phenol
Phosphorodithioic acid, 0,0-diethyl, methyl ester
Propylene dichloride
Pyridine
Resorcinol
Safrole
Selenium disulfide
Silvex
1.2.4.5-Tetrachlorobenzene
1,1,2 ,2-Tetrachloroethane
Tetrachloroethylene
2.3.4.6-Tetrachlorophenol
Thiram
Toluene
1,1,1-Trichloroethane
Trichloroethylene
Trichloromonofluoromethane (Preon ll9)
2.4.5-Tr i chlorophenol
2.4.6-Trichlorophenol
2,4,5-Trichlorophenoxyacetic acid (2,4,5-T)
Xylene
105"
-------
Appendix IV-4
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Inert Ingredients:
Acetone
Acetonitrile.
Acetophenone
Acrylic acid
Aniline
Benzene
Chlorobenzene
Chloroform
Cyclohexane
Cyclohexanone
Dichlorodifluoromethane (Preon 12*)
Diethyl phthalate
Dimethylamine
Dimethyl phthalate
1,4-Dioxane
Ethylene oxide
Formaldehyde
Formic acid
Isobutyl alcohol
Meleic anhydride
Methyl alcohol (methanol)
Methyl ethyl ketone
Methyl methacrylate
Naphthalene
Saccharin and salts
Thiourea
Toluene
1.1.1-Trichloroethane
1.1.2-Trichloroethane
Trichlorofluoromethane (Freon 11®)
Vinyl chloride
Xylene
lOfc
------- |