x>EPA
United StatM
Environmental Protection
Agency
Off ice of
Pvtticidw tnd Toxic Subttanoat
Washington DC 20460
September 1985
Guidance for the
Reregistration of
Pesticide Products
Containing Trimethacarb
as the Active Ingredient
-------
CASE NUMBER 112
GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
AS THE ACTIVE INGREDIENT
TRIMETHACARB
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
-------
TABLE OF CONTENTS
Introduction 1
I. Regulatory Position and Rationale 4
II. Requirement for Submission of Generic Data 49
III. Requirement for Submission of Product-Specific
Data * 52
IV. Submission of Revised Labeling 52
A. Label Contents 53
B. Collateral Information 58
V. Instructions for Submission 59
-------
APPENDICES
Page
II-l Guide to Bibliography 62
II-2 Bibliography 64
II-3 FIFRA §3(c)(2)(B) Summary Sheet - EPA Form 8580-1
II-4 Certification of Attempt to Enter Into an Agreement
with Other Registrants for Development of Data
EPA Form 8580-2
III-l Product Specific Data Report (End-Use Products)
IV-1 40 CFR 162.10 Labeling Requirements
IV-2 Table of Labeling Requirements
IV-3 Physical/Chemical Hazards Labeling Statement
IV-4 Storage and Disposal Instructions
11
-------
INTRODUCTION
The Federal Insecticide, Fungicide, and Rodentlcide Act
(FIFRA sec. 3(g)) directs EPA to reregister all pesticides as
expedltiously 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 upo'n 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 hazards 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 o'n the
registrants of the manufacturing use products (basic suppliers
-------
of the active ingredient) and other producers who do not
qualify for the formulator's exemption.*
A producer who wishes to qualify for the formulator'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. A 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
reglstratlon(s), you must provide the information described in
the following pages within the timeframes outlined. EPA will
issue a notice of intent to 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
product if the source of his active ingredient(s) :• (1) is a
registered product and (2) is purchased from a source which
does not have ownership in common with the registrant's
firm.
-------
PRODUCTS SUBJECT TO THE
REGISTRATION STANDARDS PROGRAM
ACTION(S) REQUIRED TO
MAINTAIN REGISTRATION
I. Products That Do Not Qualify
For The Pormulator'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 continue the registration of
the active ingredient under
review, as described In the
Registration Standards Guidance
Document, will be required and
some labeling precautions may
also be required.
II. Products That Do Qualify For
The Pormulator's Exemption
Only when additional restric-
tions or labeling are needed to
protect man or the environment
will these products be subject
to the Registration Standard
requirements. Affected products
will be dealt with in a variety
of ways, Including but not
limited to the Label Improvement
Program and special intent
to cancel notices.
* End use products of registrants who also produce a manufacturing
use product will not be required to be reregistered provided that
registrant fulfills the requirements .specified in the Guidance
Document for manufacturing use product(s). Such end use products
will be subject to the labeling changes required for products in "II"
above. 'If there are no manufacturing use products registered by 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 and B above, then the registrants in "II" lose their right to
qualify for the formulator's exemption and become subject to the
requirements in I-A and ,B.
-------
I. REGULATORY ASSESSMENT
A. INTRODUCTION
This chapter contains the Agency's regulatory position and
rationale on products containing the pesticide trimethacarb as
a sole active Ingredient. The Agency bases its position and
rationale on a consideration of all uses of trimethacarb appearing
on pesticide products registered under Sections 3 and 2U(c) of
PIPRA as well as on products authorized for distribution in
intrastate commerce under 40 CPR §162.17. The Agency has reviewed
the known chemical, environmental, and toxlcological characteristics
of this pesticide and its established tolerances for residues in
or on corn. Based on this Information, the Agency has established
data and labeling requirements that must be met by registrants
and applicants for registration of trimethacarb manufacturing-use
products (MPs) in order for their products to be registered or
reregistered under this Standard. Unique labeling requirements
and certain data needs for end-use products (EPs) containing
trimethacarb are also established by this Standard.
Only those data and labeling requirements for current MPs
and EPs and substantially similar ones registered in the future
are addressed here. Applications to register products that
differ appreciably from those described in this Standard may be
subject to additional data and/or labeling requirements.
-------
B. DESCRIPTION OF CHEMICAL AND USE PROFILE
Trlmethacarb Is the American National Standard Institute's
(ANSI) approved name for an insecticide composed of two isomers
that Is produced by Union Carbide Agricultural Products Company.
The chemical name for trlmethacarb is 3,4,5-trlmethylphenyl
methylcarbamate and 2,3,5-trimethylphenyl methylcarbamate. Other
names Include the names Broot®, Landrin® and code names UC 27867
and QMS 597.
Other Identifying characteristics and codes are:
Empirical Formula: C11H15N02
Molecular Weight: 193.24
CAS Registry Numbers: 2686-99-9 (3,1,5-isomer)
3971-89-9 (2,3,5-isomer)
Shaughnessy Numbers: 102401 (3t4 ,5-lsomer)
102402 (2,3,5-isoraer)
Technical trimethacarb is a buff to brown crystalline
powder with a mild ester odor. The melting point is 105-11^ °C.
Trimethacarb is soluble in water to 58 ppm at 23 °C and
hydrolyzes to trimethylphenol's, C02, and methylamine at pH values
greater than pH 8.
Union Carbide Agricultural Products Company is the sole
producer qf trimethacarb and markets two" EPs under the trade name
Broot®. These are a 15% granular formulation and a 50% wettable
powder formulation. There are no intrastate products. There are
no federally registered MPs containing trimethacarb.
-------
Trimethacarb is registered to control corn rootworra on field
corn and popcorn. Application Is made once per season at planting.
Tolerances for food/feed items are currently expressed as the
sum of the residues of both isomeric components of trimethacarb
[the sum of 3,1,5 and 2,3,5-trimethacarb] (40 CFR 180.305).
C. REGULATORY POSITION AND RATIONALE
Based on a review and evaluation of all available data and
other relevant information on trimethacarb, the Agency has made
the following determinations:
1. All products containing trimethacarb as a sole active
ingredient may continue to be registered for sale,
distribution, reformulation, and use, subject to the
terms and conditions specified in this Guidance Document.
Registrants must provide or agree to develop additional
data, as specified in Tables A, B and C In order to
maintain existing registrations or to permit new
registrations.
Rationale; Under PIPRA, the Agency normally does not
cancel or withhold registration simply because data are
missing or are inadequate (see Sections 3(c)(2)(B) and
3(c)(7) of the PIPRA). Rather, Issuance of this Standard
provides a mechanism for Identifying data needs. These
data will be reviewed and evaluated when they are received
and the Agency will determine at that time whether they
will affect the registrations of trimethacarb.
-------
The existing data base, although minimal, and use history
do not suggest that there are any hazards to mixers,
loaders, or applicators who follow label use directions
and precautions. According to the Pesticide Incident
Monitoring System (PIMS), there have been no reports of
human or domestic animal incidents.
2. The Agency will not allow any significant new uses* to
be granted for trimethacarb until the toxicologlcal and
residue chemistry data deficiencies identified in
Table A have been satisfied.
Rationale; The Agency Is unable to complete a tolerance
reassessment of trimethacarb because of residue chemistry
and toxicology data gaps. The data requested in Table A
are needed for EPA to determine an acceptable daily
Intake (ADI) level of trimethacarb and its metabolites
and to reassess the'present tolerances. (Refer to
Section G for a discussion of the tolerance reassessment)
* The terminology "significant new use" is defined in 44 PR 27934,
May 11, 1979. In the case of a new food or feed use, the
Agency will generally consider a new use to be significant if it
would result in an increase in the Theoretical Maximal Residue
Concentration (TMRC) of greater than 1%.
-------
The Agency will not allow any significant new uses until
the toxicologlcal and residue data have been received,
evaluated, and the Agency concludes that new uses are
supportable.
3. The Agency is requiring environmental fate data to fully
assess trlmethacarb'a behavior in the environment.
Pending the submission of crop rotation data; EPA is
requiring a crop rotation restriction for EP labels
which only permits planting of crops registered for
trimethacarb use in trimethacarb treated soils.
Rationale; At present, there are no acceptable studies
available to assess the environmental fate of trimethacarb,
The existing data are insufficient to characterize
trimethacarb1s degradation, metabolism, dissipation and
mobility, including J,ts potential to leach in soils or
contaminate groundwater. Trimethacarb is not on the
Groundwater Data Call-in List. Also, there are a lack
of adequate* accumulation data on trimethacarb residues
In rotational crops and fish. Because of insufficient
crop rotation data, the Agency is. Imposing the crop
rotation label restriction.
8
-------
The required residue chemistry plant metabolism data
must demonstrate whether residues of certain manufacturing
Impurities may occur In the raw agricultural commodity
as a result of application of trlmethacarb at the registered
maximum application rate. The specific chemical names
are not Included here because they are considered
Confidential Business Information.
Rationale: The Agency Is aware that one of the
manufacturing Impurities present In technical trlmethacarb
was recently classified as a tumorlgen In the Registry
of Toxic Effects of Chemical Substances. Additionally,
the Agency has recently received a study by the National
Toxicology Program which suggests that this same impurity is
an oncogen and mutagen. The Agency has not yet formally
reviewed this study. If, upon review, the Agency concludes
that the chemical is an oncogen, .a determination will be
made as to Its potency and potential human exposure so
that a hazard assessment can be conducted and appropriate
regulatory action can be taken, if necessary. To insure
that data will be present to evaluate any potential risk,
the Agency is requiring the registrant to submit data
indicating whether the impurity will be present, and if
so, at what levels in the raw agricultural commodities.
-------
5. In order to more fully assess the Impact of trlmethacarb
on avlan, fish and freshwater Invertebrate species, an
acute avlan oral toxlclty study, an acute toxlclty
study on freshwater Invertebrates, and environmental fate
studies must be conducted and submitted. Using current
estimation techniques, no hazard was predicted from the
use of trlmethacarb to endangered species. Due to toxlclty
to cold water fish, labeling cautioning against exposing
fish Is required. Refer to section P(d) (l).and(2) for the
required labeling statements.
Rationale; Based on studies available to assess potential
hazards to avlan and aquatic organisms, technical
trlmethacarb Is characterized as slightly toxic to birds
on a dietary basis and moderately to highly toxic on an
acute oral basis. Available data are adequate to
demonstrate that technical trlmethacarb Is highly toxic
to cold water fish species. Accordingly, labeling Indicating
toxlclty to fish, required by 40 CPR 162.10 (h)(2)(11)(B)
must be added to the label. There are no available
data on trlmethacarb's effects on freshwater aquatic
Invertebrates. Once the Agency has reviewed the required
environmental fate data, acute avlan oral toxlclty
data, and the acute toxiclty data on freshwater Invertebrates,
the toxlclty of this compound can be reevaluated and an
exposure assessment can be made to determine the hazard
potential of trlmethacarb1s use.
10
-------
6. Studies on trimethacarb's acute, subchronlc, and chronic
mammalian toxicity must be submitted. Acute oral toxlclty
data In the rat and dog place the technical trimethacarb
in Toxicity Category II. Acute dermal toxicity data In the
rabbit place technical trimethacarb in Toxicity
Category III.
Rationale; The existing toxicology data base Is Inadequate
to characterize trimethacarb's toxicity, except for
acute oral and dermal effects and subchronic dermal
effects. A teratology study in rats, which is considered
only of supplemental value due to reporting of data
deficiencies suggests that trimethacarb Is not teratogenic
at the doses tested.
When trimethacarb tolerances were originally established, a
90-day dog and rat feeding studies and a 2-year rat feeding
study were used to support these tolerances. Upon
reevaluatlori, a no observable effect level (NOEL) could
not be determined because these data have been found to be
unacceptable due to study design and reporting of data
deficiencies. However, they do not suggest any adverse
effects. The existing toxicology data base does not
Include any studies conducted by Industrial Bio-Test
Laboratories, Inc. Additional acute, subchronic and
chronic toxicology are needed to support the current
tolerances and use levels on corn.
II
-------
7. Registrants of MPs and EPs must submit revised labeling
which Incorporates the label precautions found In Section P,
Rationale; The Agency believes that label statements
prescribed In this Guidance Document should minimize the
acute hazards to users of -trlmethacarb and to terrestrial
and aquatic organisms.
Acute toxlclty data on freshwater fish Indicate that
precautionary labeling Is required. This requirement
Is addressed In Section F. The required acute toxlclty
precautionary statements are specified In 40 CPR 162.10.
D. CRITERIA FOR REGISTRATION UNDER THIS STANDARD
To conform to this Guidance Document, products must contain
trimethacarb as the sole active Ingredient, bear required labeling,
and conform to the product composition, acute toxiclty limits,
and.use pattern listed in the attached index of the registered
uses.
The application for registration or reregistration of
manufacturing-use and end-use products subject to this Guidance
Document must comply with all terms and conditions described in
it, including submission of an up-to-date Confidential Statement
of Formula, certification of ingredients statement, revised
labeling, commitment to fill data gaps on the schedule specified
by the Agency and, when applicable, offer to pay compensation as
required by 3(c)(l)(D) and 3(c)(2)(D) of the Federal Insecticide,
Fungicide, and Rodentlclde Act (FIFRA), as amended, 7 U.S.C.
12
-------
136(c)(l)(D) and 136(e)(2)(D). Registrants of end-use products
who qualify for the Pormulator's Exemption must submit five (5)
copies of draft labeling incorporating the unique labeling statements
identified in Section P.
E. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
To conform to this Guidance Document, manufacturing-use
products and end-use products must contain trlmethacarb
as the sole active ingredient. Each MP and EP formulation
proposed for registration must be fully described with
an appropriate certification of limits, stating maximum
and minimum amounts of the active and intentionally added
inert ingredients which will be present in products.
2. Acute Toxicity Limits
The Agency will consider registration of technical
grade, manufacturing-use and end-use products containing
trimethacarb, provided that the product labeling bears
appropriate precautionary statements for the acute
toxlcity category in which each product is placed. The
attached index entry lists all registered uses (and
intrastate label uses*) .as well as approved maximum
application rates and frequencies.
* Intrastate uses have not been reviewed for acceptability under
sec. 3 of the PIPRA. Therefore, these uses may not be added
to any product registered under sec. 3 until the supporting
data have been submitted, reviewed, and found to be acceptable.
13
-------
P. REQUIRED LABELING
All manufacturing-use and end-use trlmethacarb products must
bear appropriate labeling as specified in 40 CPR 162.10. In
addition to the above, the following information must appear on
the labeling:
a. Ingredient Statement
The Ingredient statement for MPs and EPs must list the
active ingredient as:
Trlmethacarb (3,4,5-trimethylphenyl
methylcarbamate mixture with 2,3,5 trimethylphenyl
methylcarbamate approximately 4:1) %.
b. Use Pattern Statements
All MP trimethacarb products must state that they are
intended for formulation into other manufacturing-use
products or end-use products for uses accepted by the
U. S. Environmental Protection Agency.
A limiting factor will be data that support the use
pattern. No use may be included on the label where the
registrant fails to agree to comply with the data require-
ments in either Table A or Table B for that use pattern.
The attached "EPA Index to Registered Pesticides" entry
summarizes the currently acceptable use for trlmethacarb
including site of application, target pests, dosage
rates, restrictions and limitations, and the method and
frequency of application.
14
-------
c. Acute Toxicity Precautionary Statements
Labels for MPs and EPs must bear statements reflecting
the compound's acute human toxicity. The acute oral
toxlcity data are sufficient to categorize the current
EP formulations as Toxicity Category II. The required
precautionary statements associated with this category
are specified in 40 CPR 162.10.
d. Environmental Hazards Statements
1. The following revised environmental hazard statement
must appear on all MP labels:
"ENVIRONMENTAL HAZARDS
This pesticide is toxic to fish and wildlife.
Do not discharge effluent containing this active
Ingredient into lakes, streams, ponds, estuaries,
oceans, or public waters unless this product is
specifically Identified and addressed in an NPDES
permit. Do not discharge effluent containing this
product to sewer systems without previously notifying
the sewage treatment plant authority. For guidance
contact your State Water Board or Regional Office of
the EPA."
2. For end-use products revise the existing environmental
hazards statement must read:
"ENVIRONMENTAL HAZARDS
This pesticide is toxic to fish and wildlife. Do
not apply directly to water or wetlands. Drift and
runoff from treated areas may be hazardous- to fish
in neighboring aquatic sites. Do not contaminate.
water by cleaning of equipment or disposal of waster.
15
-------
e. Crop Rotation Statement
For EPa, the product label must Include the crop rotation
statement in the use directions:
"Do not plant crops used for food or feed which are not
registered for use with trimethacarb in soils previously
treated with this chemical."
G. TOLERANCE REASSESSMENT
U.S. tolerances for negllble residues of"trimethacarb
in or on raw agricultural commodities are as follows
(40 CPR 180.305):
0.1 ppm in or on corn grain (including field corn and
popcorn), corn fodder and forage.
There are no international tolerances or Codex Maximum
Residue Limits (MRLs) for residues of trimethacarb in or
on corn grain or in animal products.
It is concluded that the plant .metabolism of trimethacarb
is not adequately described because residues in mature
corn kernels were not qualitatively and quantitatively
characterized. Additional data are necessary to characte-
rize the distribution and metabolism of trimethacarb in
the mature corn plant.
16
-------
Although no tolerances exist for residues of trimethacarb
in animal products, the nature of the residue in animals
is adequately understood at this time. Trimethacarb or
its animal metabolites do not accumulate in edible tissue
of cattle. In a cattle feeding study, no l^C residues were
detectable in the muscle, fat or kidney of cattle which
were fed radlolabeled trimethacarb. However, if the
requested plant metabolism data reveal additional metabo-
lites of toxicologlcal concern, the conclusions regarding
the nature of residues in animals may change and additional
animal metabolism data will be required.
The residue analytical methods for enforcement of toler-
ances covering the sum of the residues of 3j^,5- and 2,3,
5-trimethacarb in or on plant commodities are adequate.
However, if the requested plant metabolism data reveal
additional metabolites of toxicological concern or if the
present residue analytical methods will not adequately
determine all conjugated residues of concern then
submission of additional validated methods for data
collection and tolerance enforcement will be required.
U.S. tolerances for corn grain, fodder and forage are not
supported by the available residue chemistry data.
17
-------
Additional data required are as follows:
1. Data depicting residues in or on mature field corn
grain harvested 90 days after application according
to label use directions.
2. Residue data are required for corn oil and milled
products to determine whether or not residues
concentrate. (If residues do concentrate in an*
of the processed products, the registrant is required
to submit a petition for tolerances. However, If food
additive tolerances are necessary and if other required
residue data demonstrate the presence of any impurities
that are shown to be oncogenic (see Section C.4., above),
there will be a conflict with the section 109
of the Federal Pood, Drug and Cosmetic Act. This
section prohibits the establishment of food additive
tolerances for additives found to be carcinogenic).
3. Additional data are required that depict residues in
or on corn forage, fodder and silage harvested after
a single at-plantlng application. A pregrazlng
interval must be established and a tolerance for
residues In or on silage must be established.
The chronic toxicology studies used to support these
tolerances (a 90 day dog feeding study, a 2 year rat
feeding study and a 90 day rat feeding study) upon
18
-------
reevaluation have been found to be inadequate.
The adequacy of the established tolerances covering residues
of trimethacarb on or on corn grain, forage, and fodder
cannot be determined at the present time due to significant
gaps in residue chemistry and toxicology. At present,.
no acceptable toxicology study exists for calculation of
the acceptable daily intake (ADI) or provisional acceptable
daily intake (PAOI). Until acceptable data are submitted
no ADI can be calculated. Data gaps are discussed in
Table A.
A permanent tolerance of 0.1 ppm was granted for corn
grain which results in a theoretical maximum residue
contribution (TMRC) of 0.0016 mg/day for a 1.5 kg diet.
U.S. Tolerances
Crop Maximum Residue Limit (PPM)
field corn (grain) 0.1
popcorn (grain) 0.1
corn forage 0.1
corn fodder 0.1
No Codex, Mexican, or Canadian tolerances exist for
trimethacarb in or on corn.
19
-------
EPA Index to Pesticide Chemicals
TRIMETHACARB*
TYPE PESTICIDE; Insecticide
FORMULATION:
G
WP
(15%)
(50%)
GENERAL WARNINGS AND LIMITATIONS; Trimethacarb is toxic to fish,
Do not apply directly to water or wetlands. Drift and runoff
from treated areas may be hazardous to fish in neighboring areas,
TERRESTRIAL FOOD CROP
(Agricultural Crops)
General Warnings and Limitations; Do not plant any food or feed
crop other than those with registered trimethacarb treated soils
Site and Pest
Dosages and Tolerance, Use, Limitations
Formulation(s)
Corn (field corn and popcorn)
0.1 ppm corn grain (including
field corn and popcorn) and
corn fodder and forage (such
tolerances to cover the sum
of the residues of both
components)
90-day preharvest interval
through 1.2 ounces per 1,000
feet of row or 1.35 pounds
per acre at 30-inch row
spacing, for soil application
at planting (band).
•Broot
3,4,5-trimethylphenyl methylcarbamate and 2,3,5-trime'thylphenyl
methylcarbamate
20
-------
EPA Index to Pesticide Chemicals
TRIMETHACARB
Site and Pest
Corn rootworms
(continued)
Dosages and
Pormulation(s)
1.2 oz/1,000
ft of row
or
1-1.31 lb/A
[30-40 inch
row -spacing]
(15% G)
or
0.9-1.2
oz/1,000 ft
of row
(50% WP)
or
0.75-1.35
lb/A
[30-40 inch
row spacing]
(50% WP)
Tolerance, Use, Limitations
Soil application at planting
(band). Apply a 6 to 8 inch
band over the row. Incorporate
by applying behind the
covering disc and ahead of
the press wheel. Apply
wettable powder in a minimum
of 6 to 8 gallons of water
per 13,068 linear feet
(equivalent to 1 acre with
40-inch row spacing). Amount
applied per acre depends on row
spacing.
21
-------
EPA Index to Pesticide Chemicals
TRIMETHACARB
Listing of Registered Pesticide Products by Formulation
15t granular
trimethacarb (102401 and 102402)
00026*4-00381
50% vrettable powder
trimethacarb (102401 and 102402)
000264-00382
22
-------
EPA Index to Pesticide Chemicals
TRIMETHACARB
Appendix B
Listing by Site/Pest and Site/Formulation/Registration Number
Corn
Corn rootworms
(15* G)
000264-00381
(50% WP)
000264-00382
23
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: TRIMETHACARB
Guideline Citation and Test
Name of Test Substance
§158.120 Product Chemistry
Product Identity:
61-2 - Description of Beginning
Materials and Manufacturing
Process
61-3 - Discussion of Formation of
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis
62-3 — Analytical Methods to Verify
Certified Limits
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-1 - Odor
63-5 - Melting Point
TQAI
TQAI
TQAI
TGAI
TQAI
TQAI
TGAI
TGAI
Guidelines Are Data Footnote
Status Required Number
Yes No
R m r~] 2
R [~] [X]
CR [X] [~] 3
R fiC] IT"] 1
R r] DC]
R n m
R n [x]
R n tx]
Data Must Be
Submitted Within
Time Frames Listed
Below I/
6 Months
12 Months
12 Months
• • • • • 0 •
24
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: TRIMETHACARB
Guideline Citation and
Name of Test
Test Guidelines
Substance Status
Are Data Footnote
Required Number
Yes No
Submitted Within
Time Frames Listed
Below IL
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-7 - Density, Bulk Density, or
Specific Gravity
63-8 - Solubility
63-9 - Vapor Pressure
63-10 - Dissociation constant
63-11 - Octanol/water partition
coefficient
63-12 - pH
63-13 - Stability
Other Requirements:
61- 1
- Submlttal of samples
TOAI
TOAI or PAI
PAI
PAI
PAI
TOAI
TGAI
TOAI, PAI
R
R
R
R
R
R
R
CR
Cx]
m
Cx]
CX]
Cx]
0
n 5
r] 6
T]
n
r~] 5
T] 5
C~] 7
en
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
25
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL TRIMETHACARB
§158.120 Product Chemistry
TGAI • Technical Grade of the Active Ingredient; PAI • Pure Active Ingredient; R • Required; CR = Conditionally Required
I/ Data must be submitted within the Indicated time frames, which begin on the date of the Guidance Document. (See
front cover for the date).
2/ Details of the manufacturing process Including the relative amounts of beginning materials, a description of the
equipment used to produce the product, reaction conditions, the duration of each step of the process, the purification
procedures and quality control measures for the unregistered technical must be submitted.
3/ Five or more representative samples should be analyzed for the amount of active Ingredient and each Impurity present
for which a certified limit Is required. Data regarding the accuracy of the methods used to determine the active
ingredient and Impurities In the samples of the technical product must be submitted.
V Qualitative methods to determine trlmethacarb and all Impurities In the technical product are needed. Each method
must be accompanied by validation studies of the accuracy of the method.
5/ The temperature at which the assay was run Is needed.
6/ The solubility of the technical In polar and non-polar solvents at 20°C or 25°C must be reported In g/lOOml or rag/kg.
?/ Information must be submitted as to the sensitivity of the technical product to metal Ions and metal.
26
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL : TRIMEIHACARB
Must Additional Data
Be Submitted Under
PIPRA § 3(c)(2)(B)?
Time Frames Por Data
Submission 2/
Data Requirements
Composition
Does EPA Have Data
To Satisfy This
I/ Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
§158.125 Residue Chemistry
171-2 - Chemical Identity
171-4 - Nature of Residue (Metabolism)
- Plants
TGAI
PAIRA
Yes
Partially
- Livestock
171-1 - Residue Analytical Method
- Plant residues
PAIRA and Plant
Metabolites
Yes
TGAI and Metabolites Yes
00130616
00070071
00095891
00095892
00095893
00095928
00070071
00095928
00070661
00070967
00095900
00095901
00095906
00095907
00095908
00095909
GS0112001
No
Yes 3/ 24 Months
Reserved
Reserved 5/
27
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL
TRIMETHACARB
Jata Requirements
Composition
Does EPA Have Data
To Satisfy This
I/ Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FEbHA § 3(c)(2)(B)7
Time Frames For Data
Submission 2/
158.125 Residue Chemistry - Continued
171-4 - Magnitude of the Residue-
Residue Studies for Each
Pood Use
- Cereal Grains Group6/
o Crop - Corn
— Crop field trials
— Processed Pood/Feed
— Meat/Milk/Poultry/Eggs
Forage, Fodder, and Straw
of Cereal Grains Group10/
o Com, forage
fodder
silage
— Crop Field Trials
— Meat/Milk/Poultry/Eggs
TEP
EP
TCAI or Plant
TEP
1GAI or Plant
Metabolites
Partially
No
Yes
Partially
Yes
00070967
00070662
00070072
00070967
00095900
00070662
00070072
Yes 7/ 42 Months
Yes 8/ 42 Months
No 9/
Yes ll/ 12 Months
No 9/
28
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL TRIMETHACARB
§158.125 Residue Chemistry - Continued
I/ Composition: TGAI = Technical grade of the active Ingredient; PAIRA = Pure active ingredient, radiolabelled; TEP =
Typical end-use product; EP = End-use product.
2/ Data must be submitted within the indicated time frames, which begin on the date of the Guidance Document. (See
front cover for the date). .
3/ Additional metabolism data are required to reflect the distribution and metabolism of ring-labeled LiqCJ3,|lf5- and
2,3,5-trlmethacarb in mature corn (foliage and grain) following at-planting application. There is a concern about
the presence of certain manufacturing Impurities in technical trimethacarb because one of these impurities was
recently classified as a tumorigen in the Registry of Toxic Effects of Chemical Substances. The registrant must
indicate whether residues of this compound and the other compounds listed may result in the in raw agricultural
commodity as a result' of the maximum registered use. Refer to CBI attachment for identification of Impurities.
V If the requested plant metabolism data reveal additional metabolites of toxicologlcal concern, the nature of the
~~ residue in animals may change.
5/ If the requested plant metabolism data reveal additional metabolites of toxicological concern or if the methods
~~ will not adequately determine all conjugated residues of concern, then additional validated methods for data
collection and tolerance enforcement will be required.
6/ A drop group tolerance is not appropriate at the present time because additional residue data would be required
~ for four additional group members (fresh sweet corn, rice, sorghum and wheat).
II Additional data depicting residues in or on mature field corn grain harvested 90 days after a single at~plantir
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL TRIMETHACARB
Data Requirement
I/ Use 21
Composition Pattern
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
Muat Additional Data
Be Submitted Under
PIPHA § 3(c)(2)(B)7
Time Frame for Data
Submission J/
§158.130 Environmental Pate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis
Photodegradatlon
161-2 - In water
TOAI or PAIRA
TQAI or PAIRA
No
No
Yes
Yes
9 Months
9 Months
METABOLISM STUDIES-LAB;
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
TQAI or PAIRA A
TQAI or PAIRA A
No
No
Yes
Yes
27 Months
27 Months
MOBILITY STUDIES;
163-1 - Leaching and TQAI or PAIRA
Adsorptlon/Desorptlon
No
Yes
12 Months
30
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL TRIMETHACARB
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission V
a Requirement
I/ Use 2/
Composition Pattern
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
j8.130 Environmental Fate - Continued
)ISSIPATION STUDIES-FIELD;
L64-1 - Soil
L64-5 - Soil, Long-term
^CUMULATION STUDIES;
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-4 - In Fish
TEP
TEP
PAIRA
TEP
TGAI or PAIRA
A
A
No
NO
NO
NO
NO
Yes 27 Months
Reserved 4/
Yes /5
39 Months
Reserved /6
Yes
12 Months
31
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL TRIMETHACARB
§158.130 Environmental Pate - Continued
\l Composition: TCAI = Technical grade of the active Ingredient; PAIRA = Pure active Ingredient, radlolabelled;
TEP = Typical end-use product.
21 The use patterns are coded as follows: A=Terrestrial, Pood Crop; B=Terrestrlal, Non-Pood; C=Aquatlc, Pood Crop;
D=Aquatic, Non-Pood; B=Greenhouse, Pood Crop; P=Greenhouse, Non-Pood; G=Porestry; H=Domestlc Outdoor; l=Indoor.
3/ Data must be submitted within the Indicated time frames, which begin on the date of the Guidance (Document. (See
front cover for this date).
V Data will be required If soil residues do not reach 50 percent dissipation prior to recommended subsequent
application to the same site as Indicated by results of 162-1 or 164-1.
5/ For crops rotated on treated areas, any one of the following will apply to preclude a crop rotation restriction:
(a). A tolerance must be obtained for the rotated crop.
(b). Data must be provided to determlme time Intervals at which rotated crops planted on treated areas will
be free of trlmethacarb residues.
6/ Requirement reserved pending results of cqnflned rotational crop studies.
32
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL TRIMETHACARB
Does EPA Have
Data To Satisfy
V Use 21 This Require- Bibliographic
Data Requirement Composition Pattern ment? (Yes, No Citation
or Partially)
§158.135
Toxicology
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)7
Time Frame for Data
Submission 3/
ACUTE TESTING:
81-1 -
81-2 -
81-3-
81-7 -
Acute Oral Toxlcity - Rat TGAI A Yea
Acute Dermal Toxicity TGAI A Yes
- Rabbit
Acute Inhalation Toxlcity TGAI A No
- Rat
Delayed TGAI A Partial
Neurotoxlclty - Hen
00128130
00128130
-
00051311
00051312
00070659
No
No
Yes 9 Months
Yes V 12 Months
SUBCHRONIC TESTING:
82-1 - 90-Day Feeding : TGAI
- Rodent, and
- Non-rodent (Dog)
82-2 - 21-Day Dermal - Rabbit TGAI
A
A
No
No
Yes
00070656
No 5/
No 5/
No
33
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL TRIMETHACARB
Does EPA Have Must Additional Data
Data To Satisfy Be Submitted Under
I/ Use 2/ This Require- Bibliographic FIPRA § 3(c)(2)(B)?
Data Requirement Composition Pattern ment? (Yes, No Citation Time Frame for Data
or Partially) Submission 3/
§158.135
Toxicology - Continued
CHRONIC TESTING:
83-1 -
83-2 -
83-3 -
83-4 -
Chronic Toxlclty - TGAI
2 species:
- Rodent, and A No
- Non-rodent (Dog) A No
Oncogenlclty - TGAI
2 species:
- Rat (preferred), and A No
- Mouse ( preferred}- • • - • A No
Teratogenlclty - TGAI
2 species:
- Rat A Partial
- Rabbit A Partial
Reproduction - Rat TCAI A No
Yes 50 Months
Yes 50 Months
Yes 18 Months
Yes 18 Months
GS01 12020 Yes 6/ 6 Months
GS01 12021 Yes 7/ 6 Months
Yes 39 Months
2-generatlon
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL TRIMETHACARB
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)7
Time Frame for Data
Submission 3/
Data Requirement
I/ Use 2/
Composition Pattern
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
§158.135 Toxicology - Continued
MUTAGENICITY TESTING
84-2 - Gene Nutation (Ames Test)
84-2 - Structural Chromosomal
TGAI A No
TOAI A No
Yes 9 Months
Yes 12 Months
Aberration
81-4 - Other Genotoxlc Effects TOAI
No
Yes
12 Months
SPECIAL TESTING;
85-1- General Metabolism
PAI or PAIRA
No
Yes
24 Months
35
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL TRIMETHACARB
§138.135 Toxicology - Continued
V Composition: PAI = Pure active Ingredient; PAIRA - Pure active Ingredient, radlolabelled; Choice = Choice of several
test substances determined on a case-by-case basis.
21 The use patterns are coded as follows: A=Terrestrlal, Pood Crop; B=Terrestrlalt Non-Pood; C=Aqautic, Pood Crop;
~ D=Aquatic, Non-Pood; E=Greenhouse, Pood Crop; F=Greenhouse, Non-Pood; G=Porestry; H=Domestlc Outdoor; I=Indoor.
3/ Data must be submitted within the Indicated time frames, which begin on the date of the Guidance Document. (See
front cover for this date).
V Although delayed neurotoxlclty studies are not usually required for a carbamate, the unusual observations noted In
the studies conducted (positive for delayed neurotoxlclty) require an adequate explanation or additional studies to be
submitted.
5/ This data la not required at this time because Union Carbide Is In the process of conducting chronic feeding studies.
These studies will be required If the chronic studies are not submitted.
6/ The following data needs to be submitted: . Individual maternal weight data at the Intervals measured and historical
control data relative to cesarean section :observatIons and fetal malformation and variation observations. The
historical data should be presented by Individual study and dated and should cover a period of 2 years prior to
Initiation of this study and any studies conducted after study termination using the Fischer 3M strain from the same
vendor.
II This study Is deficient In that not all fetuses were subjected.to skeletal examination after visceral examination
as reconmeded by the Guidelines. The registrant la, therefore, required to examine those fetuses (which are
preserved) for skeletal anomalies and submit the data to the Agency.
36
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL TRIMETHACARB
Data Requirement
V Use 2/
Composition Pattern
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission 3/
§158.140
132-1
132-1
133-3
133-1
§158.142
201-1
201-1
Reentry Protection
- Foliar Dissipation
- Soil Dissipation
- Dermal Exposure
- Inhalation Exposure
Spray Drift
- Droplet Size Spectrum
- Drift Field Evaluation
TEP
TEP
TEP
TEP
TEP
TEP
A
A
A
A
A
A
No
No
No
No
No
No
No V
No 4/
No 4/
No V
No 4/
No 4/
I/ Composition: TEP = Typical end-use product.
2/ The use patterns are coded as follows: A=Terrestrlal, Food Crop; B=Terrestrlal, Non-Food; C=Aquatic, Food Crop;
~ D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestlc Outdoor; I=Indoor.
3/ Data must be submitted within the Indicated time frame, based on the date of the Guidance Document.
V No data are required because trlmethacarb does not meet the criteria described In 40 CFR 158.140 for reentry
data requirements.
37
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL TRIMBTHACARB
Data Requirement
I/
Composition
Use 21
Pattern
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
PIPRA § 3(c)(2)(B)?
Time Frame for Data
Submission 3/
S158.145 Wildlife and
Aquatic
Organisms
AVIAN AND MAMMALIAN TESTING
71-1 -
71-2 -
71-5 -
-
Acute Avian Oral Toxlclty TGAI
Avian Subacute Dietary TGAI
Toxlclty
- Upland Game Bird, and
- Waterfowl
Simulated Field Testing TEP
- Mammals, and
- Birds
Actual Field Testing TEP
- Mammals, and
- Birds
A
A
A
A
A
A
A
No
Yes
Yes
No
No
No
No
Yes
00034769 No
00031769 No
Reserved/4
Reserved/I
Reserved/1
Reserved/4
AQUATIC ORGANISM TESTING
72-1 - Freshwater Fish Toxlclty TGAI
- Coldwater Fish Species,
and
- Wannwater Fish Species
72-2 - Acute Toxlclty to
Freshwater Invertebrates
TGAI
A
A
Yes
Yes
No
GS0144-012
GS0114-012
9 Months
No
No
Yes
9 Months
38
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL TRIMBTHACARB
§158.145 Wildlife and Aquatic Organisms - Continued
I/ Composition: TQAI = Technical grade of the active Ingredient; PAI = pure active Ingredient;
~ TEP = Typical end-use product;
2/ The use patterns are coded as follows: A=Terrestrlal, Pood Crop; B=Terrestrlalf Non-Pood Crop; C=Aquatlc, Pood Crop;
~ D=Aquatic, Non-Pood; E=Greenhouse, Pood Crop; F=Greenhouse, Non-Pood; G=Porestry; H=Domestlc Outdoor; I=Indoor.
3/ Data must be submitted within the Indicated time frames, which begin on the date of the Guidance Document. (See
~~ front cover for this date).
V Requirement reserved pending avlan single-dose oral 11)50 data and environmental rate data.
39
-------
TABLE A
GENERIC DATA REQUIREMENTS TOR CHEMICAL TRIMETHACARB
Does EPA Have Must Additional Data
Data To Satisfy Be Submitted Under
I/ Use 2/ This Require- Bibliographic FIFRA § 3(c)(2)(B)?
ta Requirement Composition Pattern ment? (Yes, No Citation Time Frame for Data
or Partially) Submission V
58.150
121-1
Plant Protection
- TARGET AREA EP
pHYTorraxicm
N/A
NO 3/
MONTARGET AREA PHYTOIQXICITY
122-1
122-1
122-2
123-1
123-1
123-2
124-1
124-2
TIER I
- Seed Germination/ TGAI
Seedling Emergence
- Vegetative Vigor TGAI
- Aquatic Plant Growth TGAI
TIER II
- Seed Germination/ TGAI
Seedling Emergence
- Vegetative Vigor TGAI
- Aquatic Plant Growth TGAI
TIER III
- Terrestrial Field TEP
- Aquatic Field TEP
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
No 3/
No 3/
NO 3/
No 3/
No 3/
No 3/
No 3/
No 3/
7Composition:TGAI = Technical grade of the active ingredient; TEP = Typical end-use product. EP = End-use product.
/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food Crop; C=Aquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Gceenhouse, Non-Food; G=Forestry; H=DomestiG Outdoor; l=indoor.
/ These data are not required in accordance with 158.150.
40
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL TRIMBTHACARB
ta Requirement
I/
Composition
Use 2/
Pattern
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission V
58.155 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORS;
141-1 - Honey bee acute
contact toxicity TGAI
141-2 - Honey bee - toxicity TEP
of residues on
foliage
141-4 - Honey bee subacute
feeding study
141r5 - Field testing for TEP
pollinators
Yes
No
00078515
No
No
No/4
Reserved 5/
No/4
41
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR CHEMICAL TRIMETHACARB
a Requirement
I/ Use 2/
Composition Pattern
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(C)(2)(B)?
Time Frame Cor Data
Submission V
8.155 Nontarget Insect - Continued
JNTARGET INSECT TESTING -
IATIC INSECTS:
42-1 - Acute toxicity to
aquatic insects
42-1 - Aquatic insect
life-cycle study
42-3 - Simulated or actual
field testing for
aquatic insects
43-1 - NONTARGET INSECT
TESTING - PREDATC
hru AND PARASITES
43-3
(Reserved)/6
(Reserved)/6
(Reserved)/6
(Reserved)/6
/ Composition:TCAI = Technical grade of the active ingredient; TEP = Typical end-use product.
/ The use patterns are coded as follows: A=Terrestrialf Food Crop; B=Terrestrial, Non-Food; OAquatic, Food Crop:
D=Aqautic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; l=lndoor.
/ Data must be submitted within the indicated time frames, which begin upon receipt of the Guidance Document.
/ Since Trimethacarb is currently registered only at planting and soil incorporation, there is no potential
for bee exposure. Thus, testing beyond the first tier is not required.
i/ Reserved pending development of test methodology.
/ Reserved pending Agency decision as to whether the data requirement should be established.
42
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING CHEMICAL: TR1METHACARB
Guideline Citation and Test
Name of Test Substance
§158.120 Product Chemistry
Product Identity:
61-1 - Product Identity and Disclosure
of Ingredients
61-2 - Description of Beginning Materials
and Manufacturing Process
61-3 - Discussion of Formation of
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3 - Analytical Methods to Verify
Certified Limit
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
MP
MP
MP
MP
MP
MP
MP
MP
MP
Guidelines
Status
R
R
R
CR
R
R
R
R
R
Data Must Be
Are Data Footnote Submitted Within
Required Number Time Frames Listed
Yes No Below !/
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
2/
2/
2/
21
2/
2/
2/
2/
2/
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS TOR MANUFACTURING-USE PRODUCTS CONTAINING CHEMICAL: TRIMETHACARB
Guideline Citation and
Name of Test
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-7 - Density, Bulk Density, or
Specific Gravity
63-12 - pH
63-11 - Oxidizing or Reducing
Action
63-15 - Flaranabllity
63-16 - Explodability
63-17 - Storage Stability
63-18 - Viscosity
63-19 - Mlsciblllty
63-20 - Corrosion Characteristics
Test
Substance
MP
MP
MP
MP
MP
MP
MP
MP
MP
Guidelines
Status
R
CR
CR
CR
R
R
CR
CR
R
Are Data Footnote
Required Number
Yes No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Data Must Be
Submitted Within
Time Frames Listed
Below I/
2/
2/
2/
2/
2/
2/
2/
2/
2/
MP = Manufacturing-use Product; R = Required; CR = Conditionally Required
I/ Data must be submitted within the Indicated time frame, based on the date of the Guidance Document.
2/ There are no federally registered manufacturing use products containing trlmethacarb. Data will be required for
registration of manufacturing use products.
44
-------
TABLE C
PRODUCT SPECIFIC REQUIREMENTS FOR END USE PRODUCTS CONTAINING CHEMICAL: TRIMETHACARB
ideline Citation and Test Guidelines
rte of Test Substance Status
58.120 Product Chemistry
Product Identity:
61-2 - Description of Beginning EP R
Materials and Manufacturing
Process
61-3 - Discussion of Formation of EP R
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis EP CR
62-2 - Certification of Limits EP R
62-3 - Analytical Methods to Verify EP R
Certified Limits
Physical and Chemical Characteristics
63-2 - Color EP R
63-3 - Physical State EP R
63-4 - Odor EP R
63-5 - Melting Point TGAI R
Are Data Footnote
Required Number
Yes No
[xi n
1X1 l~]
[x] n
ix] n
[X] [ ]
[xi n
[xi n
ix) n
[x] n
Data Must Be
Submitted within
Time Frames Listed
Below I/
6 Months
6 months
12 Months
12 Months
12 Months
6 Months
6 Months
6 Months
6 Months
45
-------
Ldeline Citation and
ne of Test
TABLE C
PRODUCT SPECIFIC DATA REQUIREMENTS FOR END-USE PRODUCTS CONTAINING CHEMICAL: TRIMETilACARB .
Data Must Be
Test Guidelines Are Data Footnote Submitted within
Substance Status Required Number Time Frames Listed
Below V
Are Data
Required
Yes No
S.I20 Product Chemistry (Continued)
aical and Chemical Characteristics
>ntinued)
3-7 - Density, Bulk Density, or
Specific Gravity
.3-12 - pH
.3-13 - Stability
•3-14 - Oxidizing or Reducing
action
53-15 - Flammability
53-16 - Explodability
53-17 - Storage Stability
S3-20 - Corrosion Characteristics
EP
EP
TGAI
EP
EP
EP
EP
EP
[X]
CR
R
CR
CR
R
R
R
IX]
[X]
(X)
ixl
IX]
[X]
[X]
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
15 Months
6 Months
::::::::: i ::::::::::::::::::::::::::::::::::::::::::::::
EP = End-use Product; TGAI- Technical Grade of the active ingredient; R = Required; CR = Conditionally Required
I/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
46
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING CHEMICAL TRIMETHACARB
V
Data Requirement
Composition
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)7
Time Frame for Data
Submission
§158.135 Toxicology
ACUTE TESTING
81-1 - Acute Oral Toxlcity - Rat MP No
81-2 - Acute Dermal Toxicity MP No
- Rabbit
81-3 - Acute Inhalation Toxicity MP No
- Rat
8l-l» - Primary Eye MP No
Irritation - Rabbit
81-5 - Primary Dermal MP No
Irritation - Rabbit
81-6 - Dermal Sensltlzatlon MP No
Guinea Pig
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
I/ Composition: MP = Manufacturing-use product.
?/ There are no federally registered manufacturing use products containing trlmethacarb. Data will be required for
registration of manufacturing use products.
47
-------
TABLE C
PRODUCT SPECIFIC DATA REQUIREMENTS FOR END-USE PRODUCTS CONTAINING CHEMICAL TRIMETHACARB
ta Requirement
Composition"
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission 2/
58.135 Toxicology
ACUTE TESTING
81-1 - Acute Oral Toxicity - Rat
81-2 - Acute Dermal Toxicity
- Rabbit
t
81-3 - Acute Inhalation Toxicity
- Rat
81-4 - Primary Eye
Irritation - Rabbit
81-5 - Primary Dermal
Irritation - Rabbit
91-6 - Dermal Sensitization -
Guinea Pig
EP
EP
EP
EP
EP
EP
Yes
No.
No
No
No
No
000128130
No 3/
Yes 4/ 9 Months
Yes 4/ 9 Months
Yes 4/ 9 Months
Yes 4/ 9 Months
Yes 4/ 9 Months
/ Composition: EP = End Use Product
/ Data must be submitted within the idicated time frame, based on the date of the Guidance Document.
/ Data acceptable for both end use formulations ( 15% granular and 50% WP).
/ Data needed for both end use formulations ( 15% granular and 50% WP).
-------
REQUIREMENT FOR SUBMISSION OP GENERIC DATA
A. This portion of the guidance document Is a Notice
Issued under the authority of PIPRA sec. 3(c)(2)(B). The
tables following this section list the data required for
maintaining the reglstrablllty of each product.
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 reglstratlon(s) of your product(s)
Identified as an attachment to the cover letter accompanying
this guidance document. As required by PIPRA 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 Datal/ Must be Submitted. You may deter-
mine which generic data you must submit by consulting Table A
at the end of this chapter. That table lists the generic
data needed to evaluate the continued reglstrabillty 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 EPA needs data of that type
_!/ 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).
£/ The Pesticide Assessment Guidelines are available In hard
copy or microfiche from the National Technical Information
Service, 5285 Port Royal Road, Springfield, Va. 22161.
49
-------
for each major formulation category (e.g., emulsiflable concen-
trates, wettable powders, granulars, 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 formulation" data should not be
confused with product-specific data (Table B) which are
required on each formulation. Product-specific data are
further explained in Chapter III of this document.
C. Options Available for Complying With Requirements
to Submit Data
Within 90 days of your receipt of this Notice you must
submit to EPA a completed copy of the form entitled "PIPRA
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 Jointly 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.
25
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-U)*/
»/ PIFRA sec. 3(c)(2)(B) authorizes Joint development of
data Uy two or more registrants, and provides a mechanism by
which parties can obtain an arbitrator1s decision if they agree
to Jointly' develop data but fail to agree on. all the terms of
-the agreement. The statute does not compel "any registrant to
agree to develop data Jointly.
(Footnote continued on next page)
50
-------
OR
4. Request that EPA amend your registration by deleting
the uses'for which the data are needed. (This option is
not available to applicants for new products.)
OR
5. Request voluntary cancellation of the registrations)
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 ways to develop the required data
or how quickly 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 schedule, 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 FIFRA 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 [on terms to be agreed upon
or determined by arbitration under PIPRA Section 3(c)C2)(B).(lli)];
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.
51
-------
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.
III. 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 the 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 PIPRA 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 than six months after
you receive this guidance document.
Table B—Product-Specific Data Requirements for Manufacturing
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 OP REVISED LABELING
Motet "This section' applies to end use products only to the
extent described in Section I (Regulatory Position and
Rationale). Otherwise, the following information pertains
exclusively to manufacturing use products.
FIPRA requires each product to be labeled 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 .CPR 162.10 (see
Appendix IV-1) and are summarized for products containing
this active Ingredient as part of this Guidance Document
(See Appendix IV-2). Applications submitted in response to
this notice must include draft labeling for Agency review.
V Product specific data pertain to data that support the
formulation which is marketed; it usually includes product
chemistry data and acute toxicity data.
52
-------
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 PIFRA sec. 6(b)(l).
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-1. [40 CPR
I62.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a-
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required Identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency. See Appendix IV-1.
[40 CPR I62.10(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 I62.10(f)]
53
-------
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. See Appendix IV-1. [40 CFR
I62.10(g)]
Item 6B. POUNDS PER GALLON STATEMENT - .For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be Indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. See Appendix IV-1.
[40 CFR I62.10(h)(l)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. See Appendix IV-1.
[40 CFR 162.10 (h)(l)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation toxicity,' the word "Poison" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. See Appendix IV-1. [40 CFR 162.10(h)(1)(1)]
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)(ill)]
54
-------
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all produces, unless all
required precautionary statements appear on the front panel.
See Appendix IV- 1. [40 CPR 162 .10(h) ( 1) ( ill) ]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding -the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. See Appendix IV- 1. [40 CPR 162.10
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. [MO CPR 162.10
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. See Appendix IV- 1. [40 CPR
Item 8C. PHYSICAL OR CHEMICAL HAZARD
1. Flammabillty statement. Precautionary statements relating
to flammabllity of a product are required 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 flammabllity statements.
2. Criteria for declaration of non-f lammability . 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°P (177°C).
55
-------
c. A "non-flammable aerosol" is one which meets the
following criteria:
1. The flame extension is zero inches;
11. There is no flashback; and
ill. The flashpoint of the non-volatile liquid
component is greater than 350°P (177°C).
3. Declaration of non-flammabillty. Products which
meet the criteria for non-flammabillty specified
above may bear the notation "non-flammable" or "non-
flammable (gas, liquid, etc.)" on the label. It ma*
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 t^pe
size) in any way that may detract from precaution.
k. 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 explosivity, oxidizing or reducing
capability, or mixing with other substances to produce
toxic fumes.
Item 9A. RESTRICTED USE CLASSIFICATION - PIPRA sec. 3(d)
requires that all pesticide formulations/uses be classified
for either general or restricted use. Products classified
for restricted use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be Imposed by regulation).
• * *
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section 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 I62.11(c). You will be notified of
the Agency's classification decision.
56
-------
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 slmul-
taneo.usly. Note that the products will be assigned
separate registration numbers.
57
-------
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-lOA. 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 SLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix
IV-4 to determine the disposal instructions appropriate for
your products.
Item 10D. DIRECTIONS FOR USE - Directions for use must
be stated in terras which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects' on the environment. See
Appendix IV- 1. [UO CFR 162.10] '
B. Collateral . Labeling'
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from
those accepted in connection with registration of the product.
It should be made part of the response to this notice and
submitted for review.
58
-------
V. INSTRUCTIONS FOR SUBMISSION
A. For Manufacturing Products (MP) containing Trlmethacarb
as an active ingredient.
1. Within 90 days from receipt of this document, you must
submit to the Product Manager In the Registration Division at
the address given at the end of this section the "FIFRA Section
3(c)(2)(B) Summary Sheet" EPA Form 8580-1. Refer to'Appendix
II-3 with appropriate attachments.
If on the Summary Sheet, you commit to develop the data,
request a minor chemical exemption, present arguments that a
data requirement is not applicable, or submit protocols or modified
protocols for Agency review, you must also submit a copy of the
Summary Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data generated
in response to this notice. This Information should be submitted
to the Office of Compliance Monitoring at the address given at
the end of this section. (Actual studies are not to be submitted.)
2. Within 6 months from receipt of this document you must
submit to the Product Manager on the Registration Division:
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.
d. Two copies of draft labeling, Including the label and
associated brochures. -I-f 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. 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 PIPRA sec. 3(c)(l)(D). Refer to 40 CPR 152.80-152.99
for latest requirements.
3. Within the times set forth in Table A, you must submit
to the Registration Division all generic data, unless you are
eligible for the formulator's exemption. If for any reason any
test is delayed or aborted so that the agreed schedule cannot be
met, notify the Product Manager and the Office of Compliance
Monitoring.
59
-------
B. For Manufacturing Use Products containing Trimethacarb
in combination with other active Ingredients
1. Within 90 days from receipt of this document, you must
submit the "PIPRA Section 3(c)(2)(B) Summary Sheet," EPA Form
8580-1. Refer to Appendix II-3 with appropriate attachments.
If on the Summary Sheet, you commit to develop the data,
request a minor chemical exemption, present arguments that a data
requirement is not applicable, or submit protocols or modified
protocols for Agency review, you must also submit a copy of the
Summary Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data generated
in response to this notice. This Information should be submitted
to the Office of Compliance Monitoring at the address given at
the end of this section. (Actual studies are not to be submitted.)
2. Within the times set forth in Table A, you must submit
to the Registration Division all generic data, unless you are
eligible for the formulator's. exemption." If for any'reason any
test is delayed or aborted so that the agreed schedule cannot be
met, notify the Product Manager and the Office of Compliance
Monitoring.
C. For End Use Products containing Trimethacarb alone or in
combination with other active ingredients;
1. Within 90 days from receipt of this document, you must
submit the "PIPRA Section 3(c)(2)(B) Summary Sheet," EPA Form
8580-1. Refer to Appendix II-3 with appropriate attachments.
If on the Summary Sheet*.you commit to develop the data,
request a minor chemical exemption, present arguments -that a
data requirement is not applicable, o'r submit protocols or modified
protocols for Agency review, you must also submit a copy of the
Summary Sheet (and any supporting Information) to the Office of
Compliance Monitoring, which will be monitoring the data generated
in response to this notice. This information should be submitted
to the Office of Compliance Monitoring at the address given at
the end of this section. (Actual studies are not to be submitted.)
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-l) .
c. Two copies of any required product-specific data.
(Refer to Table C).
60
-------
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 typewritten
text on 8 1/2 x 11 inch paper or a raockup of the labeling
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 type
sizes of the text.
e. Evidence of compliance with data support requirements
of PIPRA sec. 3(c)(l)(D). Refer to 40 CPR 152.80-152.99
for latest requirements.
3. Within the time frames set forth in Table A, submit all
generic data, unless you are eligible for the formulator's
exemption.
D. For intrastate products containing Trimethacarb 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
registration.
E. Applications and other required information should be
submitted to the following address:
Jay S. Ellenberger Product Manager 12
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., SW.
Washington, D.C. 20460
Phone No. (703) '557-2386
The address for submission to the Office of Compliance Monitoring
is:
Laboratory Data Integrity Program
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW.
Washington, D.C. 20460-'
61
-------
Appendix II-l
Guide to Use of This Bibliography
CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature/ in those instances where they have
been considered, will be included.
UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials/
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject) , can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
IDENTIFICATION OF ENTRIES. The entries in.this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time^specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d){4) below for a further explana-
tion. In a few cases/ entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, -in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used ,reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
62
-------
Appendix II-1 (continued)
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the- word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated'with the earliest known submission
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the. submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
63
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Trimethacar Standard
MRID CITATION
00034769 Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary
Toxicities of Environmental pollutants to Birds. By U.S. Fish
and Wildlife Service, Patuxent Wildlife Research Center. Wash-
ington, D.C.: U.S. FWS. (Special Scientific Report—wildlife
No. 191; report no. 33423a; also in unpublished submission re-
ceived Mar 28, 1979 under 3125-236; submitted by Mobay Chemical
Corp., Kansas City, Mo.; CDL:237905-B)
00051311 Newell, G.W. (1968) Letter sent to Rene Blondeau dated Jun 10, 1968
[Demyelination potential of SD 8530]: Project No. BC 868-17.
Final rept. (Unpublished study received Jun 10, 1968 under
unknown admin, no.; prepared by Stanford Research institute,
submitted by Shell Chemical Co., Washington, D.C.; CDL:107992-A)
00051312 Newell, G.W. (1967) Letter sent to Rene Blondeau dated Oct 3, 1967
[Results of demyelination study in laying hens—Technical SD
8530]: Project No. 868-14. Final rept. (Unpublished study
received Oct 3, 1967 under unknown admin, no.; prepared by Stan-
ford Research Institute, submitted by Shell Chemical Co., Wash-
ington, D.C.; CDL:107991-A)
00070071 Shell Chemical Company (1968) Metabolism Studies. (Unpublished
study received Oct 15, 1969 under 9F0843; CDL:091458-N)
00070072 Shell Chemical Company (1968) Residues in Milk from Cow Feeding
Studies with Carbamic Acid, Methyl-, 4-(Hydroxymethyl)-3,5-xylyl
Ester. (Unpublished study received Oct 15, 1969 under 9F0843;
CDL:091458-0)
00070656 Narcisse, J.K. (1967) Letter sent to Rene Blondeau dated Aug 1,
1967 [Results of a repeated dermal toxicity study (rabbit) and
a saturated vapor toxicity study (rat) of SD 8530] : Project
No. B 868-1, Report No. 44. (Unpublished study received Oct 15,
1969 under 9F0843; prepared by Stanford Research Institute,
submitted by Shell Chemical Co., Washington, D.C.; CDL:091458-F)
00070659 Newell, G.W. (1967) Letter sent to Rene Blondeau dated Oct 3, 1967
[Results of a demyelination study, in laying hens, of Technical
SD 8530]: Project No. 868-14. Final rept. (Unpublished study
received Oct 15, 1969 under 9F0843; prepared by Stanford Re-
search Institute, Dept. of Agricultural and Environmental Tox-
icology, submitted by Shell Chemical Co., Washington, D.C.;
CDL:091458-J)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations under the Trimethacarb standard
MRID CITATION
00070662 Shell Chemical Company (19??) Residues in Cow Tissues from Feeding
Studies with Carbamic Acid, Methyl-, 4-(Hydroxymethyl)-3,5-xylyl
Ester. (Unpublished study received Oct 15, 1969 under 9F0843;
CDL:091458-P)
00070664 Shell Development Corporation (1966) Determination of SD 8530
Residues in Agricultural Crops: A Tentative Method Involving
Column Cleanup and Enzyme Inhibition-spectrophotcmetric Measure-
ment. Analytical method MMS-78/66 dated Dec 1966. (Unpublished
study received Oct 15, 1969 under 9F0843; CDL:091458-S)
00070967 Shell Chemical Company (1968) Residue Data Developed from the Use
of Landrin Insecticide on Corn. (Compilation; unpublished study
received Oct 14, 1969 under 9F0843; CDL:091456-B)
00078515 Harris, C.R.; Svec, H.J. (1970) Laboratory Studies on the Contact
Toxicity of Some Insecticides to Honeybees: Mobay Report
NO. 28755. (Canada, Dept. of Agriculture, Research Institute;
unpublished study; CDL:120480-AL)
00095891 Shell Development Company (1968) Liquid Scintillation Counting
of 14C. Method MMS-110/68 dated Oct 1968. (Unpublished study
received Aug 1, 1972 under 9F0843; CDL:093139-G)
00095892 Shell Development Company (1968) Packed Tube Combustion Method
for 14C. Method MMS-111/68. (Unpublished study received Aug
1, 1972 under 9F0843; CDL:093139-H)
00095893 Potter, J.C.; Loeffler7 J.E. (1968) Metabolic Fate of SD 8530 in
Plants: Part III. 14C Residues in Soybeans. (Unpublished
study received Aug 1, 1972 under 9F0843; submitted by Shell
Chemical Co., Washington, D.C.; CDL:093139-I)
00095900 Shell Chemical Company (1970) 1969 Residue Data for SD 16627 on
Corn from Nebraska, (unpublished study received Jul 2, 1970
under 9F0843; CDL:093546-B)
00095904 Shell Chemical Company (19??) Recovery Data for Landrin (TM) In-
secticide in Corn. (Unpublished study received Jun 5, 1969
under 9F0843; CDL:093546-F)
00095906 Shell Development Company (1968) Determination of Carbamic Acid,
Methyl-, 3,4,5-trimethylphenyl Ester: GLC—Electron Capture
Method. Method MMS-107/68 dated Jul 1968. (Unpublished study
received Jun 5, 1969 under 9F0843; CDL:093546-I)
65
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Trimethacarb Standard
MRID CITATION
00095907 Shell Development Company (1969) Determination of Landrin (TM)
Insecticide Residues: GLC Electron Capture Method. Method
MMS-115/69 dated Mar 1969. (Unpublished study received Jun
5, 1969 under 9F0843; CDL:093546-J)
00095908 Shell Development Ccmpany (1969) Determination of Landrin (TM)
Insecticide Metabolic Aglycone Residues in Crops: GLC-electron
Capture Method. Method MMS-118/69 dated Mar 1969. (Unpub-
lished study received Jun 5, 1969 under 9F0843; CDL:093546-K)
00095909 Gibson, M.E. (1970) Letter sent to George J. Beusch dated Jan 14,
1970: Landrin in corn. (U.S. Dept. of Agriculture, Science and
Education Administration, DO; unpublished study; CDL:098779-A)
00095928 Slade, M.; Casida, J.E. (1970) Metabolic fate of 3,4,5- and 2,3,5-
Trimethylphenyl methylcarbamates, the major constituents in
Landrin insecticide. Journal of Agricultural and Food Chemistry
18(3):467-474. (Also in unpublished submission received Jan
18, 1971 under 9F0843; submitted by Shell Chemical Co., Wash-
ington, D.C.; CDL:093138-AD)
00128130 Myers, R.; Christopher, S.; Mika, E.; et al. (1982) Landrin: Acute
Tbxicity and Irritancy Studies: Project Report 45-173. (Un-
published study received Dec 9, 1982 under 264-381; submitted
by Union Carbide Agricultural Products Co., Inc., Research
Triangle Park, NC; CDL:249422-A)
00130616 Union Carbide Agricultural Products Co., Inc. (1983) [Properties
of Trimethacarb]. (Compilation; unpublished study received
Aug 2, 1983 under 264-381; CDL:250890-A)
GS0112-001 Zee, K. (1970) Method tryout for Landrin on corn. In EPA Off-
icial correspondence file for Petition OF0843.
GS0112-020 Tyl, R. (1984) A Teratological Evaluation of Broot (Trimethacarb)
in Fischer 344 Rats: Project Report 46-160. Unpublished study
prepared by Bushy Run Research Center, Export, PA. 427 p.
GS0112-021 Tyl, R. (1984) A Teratological Evaluation of Broot {Trimethacarb)
in New Zealand White Rabbits: Project Report 46-161. Unpublished
study prepared by Bushy Run Research Center, Export, PA. 288 p.
GS0144-012 Johnson,; Finley, M. (1980) Handbook of Acute Toxicity of Chemicals
to fish and Aquatic Invertebrates. USDI Publication 137,
Washington, D.C.
66
-------
Append ix II-3
OMB AoorovalNo. 2000-046S (Exoina 12-31-83}
FiFRA SECTION 3(C)(2)(B) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAME
APPLICANTS NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect n tin requirement to submit "generic" data imposed by the FIFRA action 3(C)(2)(B) notice contained in the referenced
Guidance Document. I am responding in the following manner.
I will submit data in a timely manner to satisfy the following requirements. If the ten procedures I will use deviate from (or are not
specified ml the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to tne Chemicals Group, 01 CO
Chemicals Testing Programme, I enclose the protocols that I will use:
O 2. I have entered into an agreement with one or more other registrants under FIFRA section 3(CK2)(BMii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
LJ 3. I enclose a comoleted "Certification of Attempt to Enter Into an Agreement witn Other Registrants for Development of Data" with
respect to the following data requirements:
LJ 4. I request that you amend my registration by aeietjng the following uses (this option is not available to applicants tor new products):
O 5. t request voluntary cancellation of the registration of this product. (This option is not available to applicants tor new prooucu.)
REGISTRANT'S AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
EPA Perm 8580-1 (10-82)
66
-------
Appendix II—4
OMB AoofOMt No. 2000046? tExpinr 12-31-831
INTO AN AGREEMENT WITH OTHER REGISTRANTS
fTo «**. crtfyALL ***** FOR D^ELOPMENT OF DATA
1 1 tm duly authorized to represent the following firtn(i) who are ubiect to the require-
ments of • Notice under FIFRA Section 3lc)(2)(B) contained in • Guidance Document
to submit data concerning the active ingredient:
NAME OF FIRM
•
ACTIVE INGREDIENT
(This firm or group of firms is referred to below as "my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer 10 enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following reouirec
items or data:
3. My firm has offered in writing to enter into such an agreement Copies of the off era are attached. That offer was irrevocable and included an ofrer to
Bound by an arbitration decision under FIFRA Section 3lc)(2HB)(iiil if fmaragreement on all terms could not be reached otnerwise. Thu offer was ma
to the following firm(s) on the following dated):
NAME OF FIRM
-
DATE OF OFFER
However none of tnose firm(s) accented mv offer.
4. My firm requests that EPA not suspend the regisrration(s) of my firm's product(s). rf any of the firms named in paragraph (3)-aoo
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly mfoi
me whether my firm must submit data to avoid suspension of its registration(s) under FIPRA Section 3(c)(2)(B). (This stateme
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
SIGNATURE
DATE
EPA Form 8S8O-6 (10-82)
-------
Appendix III-l
EPA Registration No.
PRODUCT SPECIFIC DATA REPORT
Guidance Document for_
Date
Registration
Guideline No.
§158.20
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
Name of Test
Identity of
Ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-
density, or
specific gravity
Solubility
Vapor jpressure
Dissociation
constant
Octanol/ water
partition
coefficient
PH
Test not
required
for my
product
listed
above
(check
below)
* «
I am complying with
data requirements by
Citing MRID#'
•
.
.
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
•
•
•
68
-------
Appendix III-l (continued)
Registration
Guideline No.
63-13
63-1**
63-15
63-16
63-17
63- 18
63-19
63-20
63-21
§158.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
Stability
Oxidizing/ reducing
reaction
Planmability
Explodablllty
Storage stability
Viscosity
Mlsclbility
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral LD-50,
rat
Acute dermal
LD-50
Acute inhalation,
LC-50 rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
required
for my
product
listed
above
(check
below)
I am complying witn
data requirements by
Citing MRID0
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
-------
APPENDIX IV-1
Chapter I—Environmental Prelection Agency
it obtained the data from anoth
(Identify): applicant copied da:
m a publication: applicant obi
spy of the data from EPA).
(4) The applicant shall submit
his\ppllcation a statement that
In lu evaluation of the propeni
cacyAand safety of the form
end-use product, may not consi
data (LS supporting the app
exceptXhe following data:
(1) The data the applicant has sub-
mitted u EPA under paragraph (b) of
this section:
(2) Otter data pertaining to the
safety of toe product's active IngredJ
ents. rather than to the sqiety of the
end-use procuct: and
(3) Existing tolerances, /ood additive
regulations. ^exemptions/ and other
clearances issued undev the Federal
Food. Drug, and Cosmetic Act.
(e) It the applicant Knows that any
Item of data he^subm/tted under this
section was generated
pense of) anothe^pe
ly submitted the
predecessor. USD.
ary 1. 1970. to su
for registration.
permit, or amen
use to an existin,
reregistration <
and the on
reached wnc
y (or at the ex-
in who original-
to EPA (or Its
on or after Janu-
an application
xpenmental use
nt adding a new
.ration, or for
the applicant
dataXsubmltter have
agreement on the
amount and tr/e terms >pf payment of
any compensation that\may be pay-
able under FIFRA section
3(cXlXDXli)/wtth regard to approval
of the appllowMon). the applicant shall
submit to EPA a statement that he
has fiirnlaaed to each SUCA-identified
original data submitter
(DA notification of the applicant's
intent toApply for registration, includ-
ing the proposed product i
(2) An7 offer to pay the person com-
wtth regard to the approval
'application, to the extant re-
toy FIFRA sections 3(C)\1XD)
the
Id any result-
regarded as
^Administrator's
leiollowlng data:
{ted or specifically
it in support of
of data In the
Ing reguirationVshoulc
If it were based on the
consideration of r
(1) All datasubti
cited by the appl
the registration:
(2) Each othe/itei
Agency's files wKich:
O) Concerns the properties or effects
of any such aotlve Ingredient: and
(11) Is one/f the types Not data that
EPA would /equlre to be submitted for
scientific ofeview by EPA u\ihe appli-
cant sought the Initial registration
under B1FRA Section 3(cXTB> of a
product/with composition andMntend-
ed use/ identical to those proposed for
the Applicant's product, undek the
data/requirements In effect on\the
EPA approves the applicant's
it application.
3. 6. and 29 o< FIFRA. M
OAC. 138 et M*V.)
(44 PR T7953. Mar 11.1979)
B 16ri 0 Lefacllng requlrcnenU.
(a) General—<1) Contents of the
label Every pesticide products shall
bear a label containing the Informa-
tion specified by the Act and the regu-
lations in this Part. The contents of a
label must show clearly and promi-
nently the following:
(1) The name, brand, or trademark
under which the product is sold as pre-
scribed in paragraph (b) of this sec-
tion:
(11) The name and address of the
producer, registrant, or person for
whom produced as prescribed In para-
graph (c) of this section:
(111) The net contents as prescribed
In paragraph (d) of this section:
-------
An
9 169.10
of this secllon.
(3) Prominence and leytHHtv- (D All
words, statements, graphic represents-
lions, designs or other Information re-
quired on the Isbellng by the Act or
the regulations In this part must be
clearly legible to a person with normal
vision, and must be placed with such
consplcuousness (aa compared with
other words, statements, designs, or
graphic matter on the labeling) and
expressed In such terms as to render It
likely to be read and understood by
the ordinary Individual under custom-
ary conditions of purchase and use.
(II) All required label text must:
(A) Be set In 9-polnl or larger type:
(B) Appear on a clear contrasting
background: and
(C) Not be obscured or crowded.
(31 Laneuave to be luedL All required
label or labeling text shall appear In
the English language. However, the
Agency may require or the applicant
may propone additional text In other
language* as Is considered necessary to
protect the public. When additional
text In another language Is necessary.
all labeling requirements will be ap-
plied equally to both the English and
other-language versions of the label-
Ing.
(4) rtaetmtnt of taoef-41) Ofnrral
The label shall appear on or be secure-
ly attached to the Immediate contain-
er of the pesticide product. For pur-
poses of this Section, and the mis-
brandlng provisions of the Act. "se-
curely attached" shall mean that a
label can reasonably be expected to
remain affixed during the foreseeable
conditions and period of use. If the Im-
mediate container Js enclosed within a
fill, 40—Protection of fnvlrenmvnl Chapter I—Environmental Prelection Agency
:M.\ iv-l
Inned)
9 147.10
wrapper or outside container through
which the label rannol be clearly read.
the label must also be securely at-
tached to such outside wrapper or con-
tainer. If It Is a part of the parkage as
customarily distributed or sold.
(II) rank cars and other bulk con-
tainers—(A) Transportation. While a
pesticide product Is In transit, the ap-
propriate provisions of 49 CFR Paris
170-189. concerning the lran*porlallon
of hazardous materials, and speclllcal-
ly those provision* concerning the la-
beling, marking and placarding of has-
ardous materials and the vehicles car-
tying Ihem. define Ihe basic Federal
requirements. In addition, when r-*y
registered pesticide product Is trans-
ported In a lank car. lank truck or
other mobile or portable bulk contain-
er, a copy of the accepted label must
be attached to the shipping papers.
and left with the consignee at the lime
of delivery.
(D) Sloraor. When pesticide prod-
ucts are stored In bulk containers.
whether mobile or stationary, which
remain In the custody of the user, a
copy of the label of labeling. Including
all appropriate directions for use. shall
be securely attached to the container
In the Immediate vicinity of the dis-
charge control valve.
(S) False or mltlradtng sfatrmrnfj
Pursuant to section 2 of the
Act. a pesticide or a device declared
subject to the Act pursuant to
1163.10. ls mlsbranded If Its labeling la
false or misleading In any particular
Including both pestlcldal and non-pes-
llcldal claims. Examples of statements
or representations In the labeling
which constitute mlsbrandlng Include:
(I) A false or misleading statement
concerning the composition of the
product:
(ID A falsa or misleading statement
concerning the effectlveneas of the
product as a pesticide or device;
(III) A false or misleading statement
about the value of the product for
purposes other than as a pesticide or
device:
(Iv) A false or misleading comparison
with other pesticides or devices:
(v) Any statement directly or Indi-
rectly Implying that the pesticide or
device Is recommended or endorsed by
any agency of the Federal Govern-
menl:
(vl) The name of a pesticide which
contain* Iwo or more principal arllve
Ingredients If the name suggests one
or more bill mil all such prlnrlpnl
active Ingredients even though Ihe
names of the nlher Ingredients are
slRleil elsewhere In the labeling.
(vll) A true Klnlcmenl nneil In such a
wny as to plve n lalse or misleading Im
prcsslon In the purchaser.
(vlll) label disclaimer* wlilch negate
or ilelrncl (mm Inbcllng slnlemenLi re
quired under (lie Ac) anil these rcgula-
I Ions.
(lx> Claims IM to the safely of the
pc*llctdc or Its Ingredient.*. Including
statements such as "safe." '•nonpolsiiii
on*." "nnnlnliirloii*." "harmless" or
"nontax Ic lo Immiins unit pels" with
or without such a qualifying phrase a.*
"when used as directed . and
(x) Non numerical nnil/or cnmpnrn-
IIve slalrmciiLs on the safely of (lie
product. Including bill not limited lo
(A) "Contain* all natural Ingredi-
ent*":
(II) "Among the least loxlc chemi-
cals known"
(C) "Pollution approved"
(fl) rinnl prinrerf labrling (I) Rxcept
as provided In paragraph (aMBHll) of
(his section, final printed labeling
mii.il be submitted and accepted prior
lo reglslrallon However, final printed
labeling need nol be submit led until
draft label lexis have been provision-
ally accepted by Ihe Agency.
(II) Clearly legible reproductions or
pholo reductions will be accepted for
unusual labels such as those silk-
screened directly onto glass or metal
containers or large bag or drum labels.
Such reproductions must be of micro-
film reproduction quality.
(bl Namr. brand, or Irattrmark. (I)
The name, brand, or trademark under
which the pesticide product Is sold
shall appear on Ihe front panel of Ihe
label
(2) No name, brand, or Irademsrk
may appear on the label which:
(II Is fal*e or misleading, or
(II) Has not been approved by the
Administrator through registration or
supplemental rrRlftlrallim as an addi-
tional nnme pm*UKiiOotj| l02.H(hn4).
(c) Name and address of producer.
registrant, or person fur whom pro
duced An unqualified name and ad-
dress given on Ihe lahel shall lie cnn
sldered as Ihe name anil address of Ihe
producer If the registrant s name an
pears on Ihe Innel and Ihe registrant I*
nol Ihe producer, or If the name of Ihe
person lor whom Ihe pesticide was
produced appears on the lahel. II must
lie qualified by appropriate wording
such a* "Packed for Dlslrlbtil
ed by ' * V or "Sold hv to show
that the name Is nnl thai of Ihe IHO
ducer
(ri) Nfl ineloAf or mrmurr nf con
Irnls The nel wrlulil or measure
of conlent shall he e*clu*lve nf wrap
per.* or olher mnleilnl* and shall lie
the average content miles.* explicitly
slated a* a minimum quantity
(2) If Ihe pesticide Is a liquid. Ihe
net conlenl slalemenl shall be In
lerms of liquid measure at flfl' F (20TI
and shall be expressed In *-onvenllnnal
American units of fluid ounces pint.*.
quart.*, and gallons.
(.1) If the pesticide Is solid or semlsn
Mil. viscous or pressurised, or I* a mix
lure of liquid and solid, the net con
lent statement shall he In term* nf
welghl expressed a.* avoirdupois
pounds and ounces.
(41 In all cases, net content shall he
stated In lerms of the largest suitable
nulls. I.e.. "I pound 10 ounce*" rather
than "20 ounces."
(5) In addition lo Ihe required unltji
specified, net content may be es
pressed In metric units
(6) Variation above minimum con-
tent or around an average Is permissi-
ble only to the exlenl thai II repre-
sents deviation unavoidable In good
manufacturing practice Variation
below a stated minimum I* nol permit
ted. In no case shall the average con-
tent of the packages In a shipment fall
below Hie slalnl nvetage content
(e) rrvifurf rrpiftraUnn number
The registration number assigned to
the pesticide product at the lime nf
registration shall appear on the label.
preceded by the phrase "EPA Regis-
trallnn No.." or the phrase "EPA IIrg
No " The registration number shall be
at!, !n typr nf n slr.p and style similar In
olhiif print on ihul pr.rl of the lolml
on. which It appear* and *hsU run pur
-------
§ 141.10
•ll«l to It. The registration number
and the required Identifying phrase
shall not appear In mich a manner H
to suggest or Imply recommendation
or endorsement of the product by the
Agency.
(f) Producing eifaMliAmrntf reyit-
(radon number. The producing estab-
lishment reRlslrallon number preced-
ed by the phriuie "KPA Rsl.". of the
final establishment at which the prod-
uct wan produced may appear In any
suitable locution on the label or Imme-
diate container. It mint appear on the
wrapper or outside container of the
package If the FPA establishment reg-
Islrallon number on the Immediate
container cannot be clearly read
through (inch wrapper or container.
(R) /ncrwflent •fafement—(1) Oner-
al The label of each pesticide product
mu.il bear a statement which contains
•the name and percentage by weight of
each active InRredlenl. the total per-
centage by welghjl of all Inert Ingredi-
ents: and If the. prnllrlde contains ar-
senic In liny form, a statement of the
percentages of total and water-soluble
arsenic calculated as elemental ar-
srnlc. The active Ingredients must be
designated by the term "active Ingredi-
ents" and the Inert Ingredient* by the
term "Inert Ingredients." or the singu-
lar forms of these terms when appro-
priate. Itoth terms shall be In the
same type she. be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" Is
not required for pestlrldes which con-
lain 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) /tuition of Ingrrdlrnt itatement
(I) The Ingredient statement Is nor-
mally required on the front panel of
the label. If there Is an outside con-
tainer or wrapper through which the
Ingredient statement cannot be clearly
read, the Ingredient statement must
also appear on such outside container
or wrapper. If the sine 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
Till* 40—froUdlon «f fnvtronmvnt
(II) The tent 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) Namrt to bf vsrd In Inprrrfienf
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 J8.
M) Statements of percentaper The
percentages of Ingredients shall be
stated In terms of weight to-welghl.
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 "21-35%.' 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.
(ft) ^ccnrnrv of (fated perwmfapet
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 pres-
ent.
(6) Deterioration. Pesticides which
change In chemical composition sig-
nificantly must-meet the following la-
beling requirements:
(I) In cases where It Is determined
that a pesticide formulation changes
chemical composition significantly.
the product must bear the following
statement In a prominent position on
the label: "Not for sale or use after
I date I."
(II) The product must meet all label
claims up to the expiration time Indi-
cated on the label.
(1) Inert InprrrflenU. The Adminis-
trator may require the name of any
Chapter I—Environmental Prelection Agency
A.II.NIMX IV-I
(rnntInued)
Q 147.10
Inert Ingrerilent(s) lo be listed In the
Ingredient statement If he determines
that such Ingredient (s I may pose a
hararrf to man or the environment
(III Warnlnoi nnrf precautionary
.statement* Required warning* and
precautionary statement* concerning
the general areas of loxlcnlnglral
har.ard Including hazard to children.
environmental hazard, and physical or
chemical haxarri fall Into two groups;
those required on the front panel of
the labeling and those which may
appear elsewhere Specific require
menl.s concerning cnnlrnl. placement.
type sire, and prominence are given
below.
tl> Rronlrcrf /font panrl trarVmrnft
With the exception of the child
har.ard warning statement Hie lest re
qit'red on (he front panel of the labrl
Is determined hv the Tnxlrllv Calf-go
ry of I he pesticide I lie calrenrv Is a*
Signed on the hn.sls of the highest
hazard shown by anv of the Indlrnlnrs
In the table below
r>«no_
lip lo ml
ngttg
rmm w •»* Sim f«o/1>g
rrorn »*m»nl*
••fiHi ynn ttvy woo
vm iftm wm M^/
iDM 7oon ••» xtnm
hnm
MUHrn M IT
(I) Human hanant alqnat ward—(A)
ToiMly Catrqarv I All pesticide prod-
ucts meeting the criteria of Toxlclty
Category I shall bear on the front
panel I he signal word "Danger." In ad-
dition If the product was assigned to
Tnxlclty Category I on the basis of Its
oral. Inhalation or dermal toxlclty (as
distinct from skin and eye local ef-
fects) the word "Poison" shall appear
In red on a background of distinctly
contrasting color and the skull and
crossbones shall appear In Immediate
proximity lo the word "poison."
(HI rorfcffv Category // All pesti-
cide product* meeting the criteria of
Toxlrlly Category II shall bear on the
front panel the signal word "Warn-
ing."
(C) Toilrllv Catfporv III. All peitl-
clde products meeting Ihe criteria of
Toxlrlly Category III shall bear on
Ihe fronl panel Ihe signal word "Cau-
lion."
r(cttv Calroorv IV. All pestl-
clde products meeting the criteria of
Toxlclly Category IV shall bear on the
fronl panel the signal word "Caution."
• F) Vsr of «ionaf »>nrrf« Use of any
slRnal word(s) associated with a higher
Toxlclly Category Is not permitted
except when the Aceney determines
that such labeling Is necessary to pre
vent unreasonable adverse effects on
man or the environment In no case
shall more than one human harard
signal word appear on Ihe front panel
of a label.
(II) Child nirartf famine Fvery pes
tlclde product label shall bear on Ihe
fronl panel Ihe slalemcnl "keep out of
reach of children" Only In rases
where Ihe likelihood of contact with
children during distribution, markel
Ing. storage or use Is demonstrated by
the applicant to be estremely remote.
or If the nature of the pesticide Is such
thai It Is approved (or use on Infants
or small children, mav Ihe Arimlnlslra
tor waive this requirement.
(Ill) Statement of practical treat
mcnf-(A) Tbxicftp Catfporv I A
statement of practical treatment (first
aid or other) shall appear on Ihe front
panel of the label of all pesticides fall
Ing Into Toxlclly Category I on the
basis of oral. Inhalation or dermal log-
Icily. The Agency may. however.
permit reasonable variations In I IIP
placement of the statement of pracll
72
-------
9 162.10
cat treatment Is gome reference such
as "Sec statement of practical treat-
ment on back panel" appears on the
front panel near the word "Poison"
and the skull and crosabonea.
(B) Other toxlcUv cateportt*. The
statement of practical treatment la not
required on the front panel except as
described In paragraph thXIMIIIXA) 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-
qnlred elsewhere on the label In
accord with paragraph (h>(3) of this
section If they do not appear on the
front panel
(Iv) Placement and prominence All
the require front panel warning slale-
menta shall be grouped together on
the label, and ahall appear with suffl-
clent prominence relative to other
front panel text and graphic material
to make them unlikely to be over-
looked under customary condltloni of
purchase and use. The following table
ahowa the minimum type site require-
ments for the front panel warning
statement* on various sizes of labels:
TIMa 40—Protection of f nvlronmml Chaplar I—Environmental Protection Agency
MXM * to 10.
Mm* (0 to 11
AbM I) W M
almocfiol
6
I
10
If
(2) OMier required loarnlnpi and pre-
cautionary ttattmenU The warnings
and precautionary statements an re-
quired below shall appear together on
the label under the general heading
"Precautionary Statements" and
under appropriate subheadings of
"llacard to Unmans and Domestic Ani-
mals." "Environmental Hazard" and
"Physical or Chemical Harard."
Iftuard to ftunjani and dometHe
animal*. (A) Where a hazard elists to
humans or domestic animals, precau-
tionary statement* are required Indi-
cating the particular hazard, the
rnutefa) of exposure and the precau-
tions to be taken to avoid accident.
Injury or damage. Thp precautionary
paragraph shall be Immediately pre-
ceded by the appropriate hazard signal
word.
IB) The following table depicts typi-
cal precautionary statement*. These
statements must be modified or t\
panded to reflect specific hazards.
i
•«Mt
Oouok M*>l OB not bnMfio MODI I4M t*
•Ml OB Ml t* h •(«. on Akx et an
f PfOHt ggggMt fttfrtwngpsl fat
Irau0i •» MM On IM bract* neon IA»I et
MM) Do m 0*1 h Of««. •" •>**• «• «"
iltKJMlXt M M iWmnn i*»*wl I
*11 tt l>»oiid 01 ob«>«*il Mutf* •»
otti) taoU bnMt*« won) Idurt or *«qr "*•!
»«*) COM** ••> *M t«TM 01 CtoMngl I V*n>
pAM> In* *U Moment rao>*«tf I
INo pnMMnn; MMin
SMi «nd *r> boo) i
MUMO «r> m« Mi o»»oa» to *»•
MMonl Do no) Sri h •*•*. en i*H • «"
ftoM •*« ho»4Sn«
(Ann^rtrt. IM old ilJii i • nx»**« I
ft rrt lomi gi*i| imouii. D> m oil >i OTM.
on^*v or on «*•»•<(. HmM i M*»W l»p.
IMO
(II) environmental htuardt. Where a
hazard exists to non target organisms
excluding humans and domestic ani-
mals, precautionary statements are re-
quired stating the nature of the
hazard and the appropriate precau-
tions lo avoid potential aeildcnl.
Injury or damage. Examples of the
hazard statements and the circum-
stances under which they are required
follow:
(Al If a pesticide Intended for out-
door use contains en active Ingrrrflen'.
with a mammalian acute oral UX. of
100 or less, the statement "This Pesll-
clde Is Toxic to Wllrlllfe" IM required
(B) If a pcsllrMr Intenrird for out-
door me contains nn active Inerrrllrtit
wllh a fish unite IX7» of I pom or losi
the *Lnlcmrnl "Thli IVsllrldr Is Tnxlc
lo Fhh" l.i required
„ nf 100
Rig/kR or lew. nr a .tiitmritte tllrlary
IX;.. of 50O |>pm or less, the slatrinrnl
1 Tills IVsllrJdp Is T" tt retiiilierf
t pi For IISPS Involving foliar arpllca
ll<« not conlninliialr
water by cleanlnc of p<|iil|im«-iil nr ilK
posal ol wastes
(III! I'huilcal nr r/lrntlcnf hamnt*
Warning slalemeiil.i on I he MnmmaMI
Ml or explosive rtinrnclerlirlr^ of Hi.-
are rcqiilir.1 ax lollnwt
n,* fan •> a brfo. m-1 > *.. H .
nnh p«M ilm. lO-
KVM ••Mmton H m* »»n I* k kma X • <*il«c«
ol > H kDm *m Htm,
M olhv p.M
Oo not
f
-------
(I) The label clearly shows that the
product la Intended for line only In
manufacturing processes and specifies
thr lypc The product will not come Into
the hands of the general public except
after Incorporation Into finished prod-
uct*: and
<*) The Administrator determines
that such dlrecllona are not necessary
to prevent unreasonable adverse ef-
fecln on man or thr environment.
(II) Detailed dlreclloa* for use may
be omitted from the labeling of ptntl-
clde products for which sale In limited
to physicians, veterinarians, or drug-
gists, provided that:
(1> The label clearly stales that the
product Is for use only by physicians
or veterinarians;
(2) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fect* on man or the environment; and
«J> The product In also a dniR and
regulated tinder the provisions of the
Federal Food. Drug and Cosmetic Act.
(C) Detailed directions for usr may
be omitted from the labeling of pesti-
cide product* whicn are Intended for
use only by forrmilatora In preparing
pesticide* for aaJe to the public pro-
vided that:
(1) There b Information readily
available to the formulators on the
composition, loxlelly. methods of use.
applicable restrictions or limitations.
and effectiveness of the product for
pesticide purpose*:
(?) The label clearly stale* that the
product Is Intended for use only In
manufacturing, formulating, mixing.
or repacking for tine as a pesticide and
specifies the typets) of pesticide prod
net* Involved;
(J) Thr product as finally manufac-
tured, formulated, mixed, or repack-
aged Is registered: and
(¥) The Administrator determines
that such directions are not nrcrtsary
to prevent unreasonable advene rf
feels on man or the environment
Tit), 49—FrotccHon *f Bnvlrmtimnf
(3» CoAUnti of Directions for Vtt.
The directions for use shall Include
the following, under the headings "Di-
rections for Use*1:
(I) The statement of use clasnlllca-
tlon as prescribed In I63.KXJ) Immedi-
ately under the heading "Directions
for Use."
(Ill Immediately below the state-
ment of use classification, the state-
ment "It b a violation of Federal law
to use this product In a manner Incon-
sistent with IU labeling."
(Ill) The «tlc of application, as for
example the crops, animals, arras, or
object to be treated.
(Iv) The target peal(a> associated
with each site.
(v> The dosage rale associated with
each site and pest
tvl) The method of application. In-
cluding Instructions for dilution. If re-
quired, and lypHs) of application ap-
paratus or equipment required.
(vll) The frequency and timing of ap-
plications necessary to obtain effective
result* without causing unreasonable
adverse ef fecla on the environment.
(vlll) Specific limitations on reentry
to areas where the pesticide has been
applied, meeting the requirements
concerning reentry provided by 40
CFR Part 110
(In) Specific dlrecllona concerning
the storage and disposal of the pesti-
cide and It* container, meeting the re-
quirement* of 40 CFR Part 105. These
Instructions shall be grouped and
appear under the heading "Storage
and Disposal " This heading must be
set In type ol the same minimum sires
as required for the child hazard warn-
ing (See Table In I KLKKhKlXlvl.)
(xj Any limitations or realrlctlo..* on
use required to prevent unreasonable
adverse effects, such as:
(A) Required Intervals between ap-
plication and harvest of food or feed
crops.
(D) Rotational crop restrictions.
(C) Warnings as required against use
on certain crops, animals, object*, or
In or adjacent to certain areas.
ID) {Reserved)
(F) For restricted use pesticides, a
slaiemenl 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
Chapter I—Environmental Protection Aajvncy
AF-INIHX'IV-l
(ron I I mini)
9 16? II
but nonetheless available to thr
person .applying the pesticide, unless
the Agency has determined that thr
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who Is physically present
(F) Other pertinent Informal Ion
which thr Administrator determines
to be necessary lor the protection of
man anil thr environment.
(J) Statrmrnt ol IIaf (.7n.ij|/i<-aMon.
By October 22. 1910. all pesticide prod-
ucts musl bear nn their labels a state-
ment of \nr classification as declined
In paragraph* < |l( 11 anil (2) «f this sec
lion Any pesticide product for which
sump use* are classified fur general me
and other* lor reslrlrled u-.e shall be
separately Inhrled According In tlir Is
hrllng standards set forth In this sub-
section, mid shall bo mnrkeled a.* sepa-
rate products with different registra-
tion number*, one bearing directions
only for grnrial usc(sl and I he other
hearing direction* for leslrlclod usrfs)
except that. If a product lint both re-
strict rd used) and general use(s>, both
of these use* may appear on a product
labeled for restricted use Such prod-
uct* shall br subject to the provisions
m | 182 IOIJM2).
II) Oenrrof Vsr naiilflraflnn Pestl-
clitc products bearing directions for
usrtsl classified general shall be la-
beled with the rxacl words "Orneral
Classification" Immediately below the
heading "Direction.* lor Usr " And ref-
erence to the general clamlflcallon
that suggests or Implies that the gen-
eral utility of the pesticide extends
beyond those purposes and uses con-
tained In the Directions for Use will be
considered a false or misleading state-
ment under the statutory definitions
of mlshmnrilng.
(21 Kntrirtfd Vir Cltuiiflcallon.
Pesticide products bearing direction
for u*e(s) classified restricted shall
bear statements of restricted use clas-
sification on the front panel as de-
scribed below-
dl frortl panel itatement of retlHct-
til uir rfdHl/lcnflon (A) At the top of
the front panel of the label, set In type
ol Ihp same minimum slr.es as required
for human hazard signal words (see
table In i 162 loilin))(!»)). and appear
Inn with sulllclenl prominence relative
to other text and Rrnphlc muter)*) on
Ihr front panrl to make II unlikely to
br overlooked under customary rondl
lion* of purchase mid ii.se. Ihr stale
mrnt "Restricted list- Pesticide' «lml|
appear
(11) Directly below Mils statement on
the front panel, a .summary nlnlcmrnt
of the term* nf rrslilclhui Imtxnrd us
a precondition to rr-Rhtiaiim, Miall
appear If use I* restricted lo certified
applicators, the following Mulrmrril Is
required "For retail sale lo and nw
only by Ol lifted Appllcalor* iir (irr
sons under their direct supervision and
only for Ihose uses rnveinf liy I lie Per
lifted Applicators; ci-t lltlcallnii • II.
however, other irftiilnliiry reslrlcllnn*
are Imposed, the Administrator will
drllne the appropriate wording lor I lie
terms of restriction tiv regulation
(a.I Advertising lllrii-rve.il
KO TO isas*. jut? 3. ivn 40 nt inw
Aim I ISIS. 40 Fl< 3S«1I AUB II. l<
•mended lit 41 Pit MM Prh ft Uiai
Crliftla fot dHrrmlnalkm* nr mi
<)>) Critrria for litunnrr n( JVoflc/ nl
ffife\if to Drnv RfvlHmtton.
ation. or to ffolcf a II.
(I) PrJuumpffon. (I) A rrbullalOr prr
sumpllAii shall si lie itiat a u(>llcr of
Inlrnl loVleny rrgLstralloii pufsiiant lo
section 3?t)<8) of thr Acl /notice of
Intent to cVncel rrplslrntl/n pursuanl
lo section WbNI> of th> Act. or a
notice ol InlW to hol/a hearing In
determine wither iHe reglslrallon
Sfinuld be cancVIIrd of denlr.l. as ap-
propriate, shall >{? Usurd. upon a de
termlnallon by tlreXdmlnlslinlor that
the pesticide mretX or exceeds any of
the criteria lor rKkVsel forth In para
graph (BH3) of tAls *Xcllon. Upon such
determination/ thr\ Admlnlstralor
shall Issue notice by rVllfled mall lo
the appllcan/or rrglsl ratal, a.* the rose
may be. slating thai tne\f ppllrnnl or
registrant/has thr oppXjtiinliy to
Bubmlt evidence In rebullM ol such
preaumiAlon In accordance *Jlh para
•raph/a)(4l of this section 1\e appll
cant orY regblranl nhull have l<\ty live
(46Mtays frotn Ihr dnle such n«\lcr Is
sent to submll rvldrm-e In relmltat of
11)1 presumption; provided. howAvrr.
lal for good cause shown the AdiiHn
Istrator may grant tin additional
-------
75
nif«nui
On C"(u*"il
SfOMAGf: AMD
PRODUCT
NAME
»cirw('»ir.nioi|Ni
»iini KicntiniMii «(BA
IQIM loo im i
cnon
iins rnoinici coni»*is ins rv rmu»uo»( Vv"^
KEEPOUrOFnEACHOFCim.DnEN q(K
CAUTION «('.
JIAIIUIIH 01 riurtcM mi tunni
g VI f t I $' ^ ^^^~ ~^ ^~^ ~ "^ T* "iy,—^V- _-" __~"- - I ^"* ^"^~ — - - "
Stir r»iii ion M>niiO'i'i« SI*I|Iniir.»"(>n MI) =;
mi coNi((«s;ri:
=<©
Cnnr .-
•o
•o
TO
w*nniniv
._.__.
-------
pnECAUlONANV STATCUf NTS
HUAnDJ lOmjUAN)
II DOUfVC ANIMALS)
MAJAnps
HAJATO3
rot use
* *«••• •»•**«
RE INTRV SIAItUfNT
STORAGE AND
DISPOSAL
JS
RESTRICTED USE
PESTICIDE
for rtllU t»1r t» md vii D««r br ttrtlllid
•r ftrtem undir l»>t1r dlrid iupir»ttlc* t*d onlj Igr
*tl« to«ir«J kr (hi CtrtlHfd tppllcilert CtflKI-
PRODUCT
NAME
ACtlVC MONCOCNT
Mem wcweo«Nij
IQ1M.
tt« PRODUCT CON»»HS
IOOOOI
«»» OAUOM
KEEP OUT OF REACH OF CHILDREN
DANGER—POISON
STAff U«NT Or
l«t*rW|Mt
r
r
r OM SKN
r
srt
row »Pomo«»i. r«c*unDtiA«»
BY!
MO
EPA
MO
= «4
NCI COMffHIS:
CHOP
cnc*
Ei
•^-s
©
*-*%
h
CHOP
CHOf
CHOP
•a
•a
ft
o.
<
i
76
-------
APPENDIX IV-2
LABELING REQUIREMENTS OP THE FIFRA, AS AMENDED
ITEM
1
2
3
1|
5
6A
6B
7
7A
7B
- LABEL KT.raviRMT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
0? REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage .
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None.
None
None
<••
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
. warning
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container Instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
-------
APPENDIX EV-2 (continued)
ITEM .
7C
7D
7E
B
8A
Be
LABEL ELEMENT
Skull & cross-
bones and word
POISON (In red)
Statement of
practical
treatment
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OP REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others :
Grouped with
side panel
precautionary
statements .
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
78
-------
APPENDIX IV-2 (continued)
ITEM
8c
9A
9C.
10A
IOC
10D
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OP REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
All
cholinesterase
Inhibitors
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
'Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for 'use
None
r PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Must be set apart and clearly distin-
guishable from from other directions
for use.
May be in metric as well as U.S. units
79
-------
Appendix IV-3
PHYSICAL-CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A.
Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B,
Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
ALL OTHER PRESSURIZED
CONTAINERS
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not; over 150°F.
D. Flashpoint above
150°F.
Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or Incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or Incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or 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.
80
-------
Appendix IV-M
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
must appear in the minimum type size listed below:
Size of label
front panel in
square inches
Required type size
for the heading
STORAGE AND DISPOSAL
(all capitals)
10 and under 6 point
Above 10 to 15 8 point
Above 15 to 30 10 point
Over 30 12 point
Storage 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 increasing their prominence.
A. Storage Instructions:
All product labels are required to have appropriate storage
Instructions. Specific storage instructions are not prescribed.
Each registrant must develop 'his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
81
-------
Appendix IV-U
(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 pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage Instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
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 wording
that must appear on the label of these products:
1. The labels or' 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, MO CFR
261 for a hazardous waste must bear the following pesticide
disposal statement:
82
-------
3.
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 vour State
Pesticide or Environmental Control Agency, or che 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."
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 domes.tic use must bear one
of the following container disposal statements:
Container Type
Statement
Non-aerosol products
(bottles, cans, jars)
Non-aerosol products
(bags)
Aerosol products
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not. incinerate or punctur-e.
83
-------
Appendix IV
(continued)
2. The labels for all other products must bear container disposal
instructions, based on container type, listed below:
itainer Tvue Statement
Metal
containers
(non-aerosol)
Plastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities .
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reusedl.^ dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wording)
i/ Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
-------
Appendix IV-4
(continued)
Pesticides that are hazardous wastes under 40 CPR 261.33(e) and (f)
when discarded.
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients, (no inerts);
Acrolein
Aldlcarb
Aldrin
Allyl alcohol
Aluminum phosphide
4-Aminopyrldine
Arsenic acid
Arsenic pentoxide
Arsenic trioxlde
Calcium cyanide
Carbon disulfide
p-Chloroanlllne
Cyanides (soluble cyanide salts, not specified elsewere)
Cyanogen chloride
2-Cyclohexyl-4,6-dinitrophenol
Dieldrin
0,0-Diethyl S-[2-ethylthio)ethyl] phosphorodithioate
(disulfoton, Di-Syston)
0,0-Diethyl 0-pyrazinyl phosphorothioate (Zinophos)
Dimethoate
0,0-Dimethyl 0-p-nitrophenyl phosphorothioate (methyl parathion)
4,6-Dinitro-o-cresol and salts
4,6-Dinitro-o-cyclohexylphenol
2,4 Dinitrophenol
Dinoseb
Endosulfan
Endothall
Endrln
Pamphur
Pluoroacetamide
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methomyl
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA, schradan)
Parathion
85
-------
Appendix IV-4
(continued)
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients continued:
Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azlde
Sodium cyanide
Sodium fluoroacetate
Strychnine and salts
0,0 ,0,0-Tetraethyl dlthiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate
Thallium sulfate
Thiofanox
Toxaphene
Warfarin
Zinc phosphide
86
-------
Appendix IV-4
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Active Ingredients:
Acetone
Acrylonitrile
Amitrole
Benzene
Bis(2-ethylhexyl)pthalate
Cacodylic acid
Carbon tetrachlorlde
Chloral (hydrate)
Chlordane (technical)
Chlorobenzene
4-Chloro-m-cresol
Chloroform
o-Chlorophenol
4-Chloro-o-toluidlne hydrochloride
Creosote
Cresylic acid
Cyclohexane
Decachlorooctahydro-l,3,4-metheno-2H-cyclobuta[c,d3-pentalen-2-one
(kepone, chlordecone)
l,2-Dibromo-3-chloropropane (DBCP)
Dibutyl phthalate
S-3,3-(Dlchloroallyl diisopropylthiocarbamate (diallate, Avadex)
o-Dlchlorobenzene
p-Dichlorobenzene
Dichlorodifluoromethane (Freon 12 )
3,5-Dichloro-N-(l,l-dimethyl-2-propynyl) benzamide (pronamide,Kerb)
Dichloro diphenyl dichloroethane (ODD)
Dichloro diphenyl trichloroethane (DDT)
Dichlorethyl ether
2,4-Dichlorophenoxyacetic, esters and salts (2,M-D)
1,2-Dichloropropane
1,3-Dichloropropane (Telone)
Dimethyl phthalate
Ethyl acetate
Ethyl 4,4'-dichlorobenzilate (chlorobenzilate)
Ethylene dibromide (EDB)
Ethylene dichloride
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene
Hexachlorocyclopentadiene
Hexachloroethane
Hydrofluoric acid
87
-------
Appendix IV-4
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Active Ingredients:
Isobutyl alcohol
Lead acetate
Llndane
Maleic hydrazlde
Mercury
Methyl alcohol
Methyl bromide
Methyl chloride
2,2'-Methylenebis (3,4,6-trichlorophenol) (hexachlorophene)
Methylene chloride
Methyl ethyl ketone
M-Methyl-2-pentanone (methyl isobutyl ketone)
Naphthalene
Nitrobenzene
p-Nitrophenol
Pentachloroethane
Pentachloronltrobenzene (PCNB)
Pentaclorophenol
Phenol
Phosphorodlthioic 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 j4,6-Tetrachlorophenol
Thiram
Toluene
1,1,1-Trichloroethane
Trlchloroethylene
Trichloromonofluoromethane (Preon 11®)
2,4,5-Trichlorophenol
2,4,6-Trichlorophenol
2,4,5-Trichlorophenoxyacetic acid (2,4,5-T)
Xylene
-------
Appendix IV-4
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Inert Ingredients;
Acetone
Acetonitrile
Acetophenone
Acrylic acid
Aniline
Benzene
Chlorobenzene
Chloroform
Cyclohexane
Cyclohexanone
Dlchlorodifluoromethane (Preon 12 )
Diethyl phthalate
Dimethylamine
Dimethyl phthalate
l,i}-Dioxane
Ethylene oxide
Formaldehyde
Formic acid
Isobutyl alcohol
Meleic anhydride
Methyl alcohol (methanol)
Methyl ethyl ketone
Methyl raethacrylate
Naphthalene
Saccharin and salts
Thiourea
Toluene
1,1,1-Trichloroethane
1,1,2-Trichloroethane
Trichlorofluororaethane (Freon 11
Vinyl chloride
Xylene
------- |