United States Office of
Environmental Protection Pesticide Programs
Agency
x>EPA Pesticide
Rereglstraiion
Handbook
How to Respond to
the Reregistration
Eligibility Document
(RED)
Printed on Recycled /
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PESTICIDE REREGISTRATION HANDBOOK
HOW TO RESPOND TO THE
REREGISTRATION ELIGIBILITY DOCUMENT (RED)
OFFICE OF PESTICIDE PROGRAMS
ENVIRONMENTAL PROTECTION AGENCY
OCTOBER 1991
Printed on Recycled Paper
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PRODUCT REREGISTRATION HANDBOOK
TABLE OP CONTENTS
I. Introduction
A. Purpose and Content 1
B. Reregistration Eligibility Document i
C. Reregistration Process 1
II. Instructions for Responding
A. How and When to Respond 2
B. When No Response Is Needed 5
B. Where to Respond 6
III. Submission of Data and Labels/Labeling
A. Generic Data 6
B. Product Specific Data 7
1. Product Chemistry 7
2. Acute Toxicity 8
3. Product Performance 9
C. Labels/Labeling 10
Appendix
A. Confidential Statement of Formula and Instructions
B. Label Contents
C. Sample Label Formats--General Use & Restricted Use
D. Label Regulations (40 CFR 156.10)
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PESTICIDE REREGISTRATION HANDBOOK
I. INTRODUCTION
A. Purpose and Content of this Handbook
This Handbook provides instructions to registrants on how to
respond to the Reregistration Eligibility Document (hereafter
referred to as the “RED”) and how to reregister products.
Section I is this introduction.
Section II contains step-by--step instructions which must be
followed by registrants responding to the RED.
Section III provides additional instructions on the format,
content and other aspects of generic data, product specific data
and labels/labeling which may be required to be submitted.
Detailed instructions are in the Appendix.
B. The Reregistration ElicUbility Document (RED )
Under Section 4 of the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA), as amended in 1988, EPA is required to
reregister pesticides that were first registered before NQvember 1,
1984. The RED describes in detail the subject chemical, its uses
and its regulatory hi.story; describes EPA’S decision concerning the
eligibility of the uses of the chemical for reregistration; and
explains the scientific and regulatory bases for this decision.
EPA’s reviews 1 of the data by scientific discipline are available
upon request. Appendices to the RED contain: (1) a Data Dali-In
Notice which requires submission of generic and product specific
data and which gives dir ctions for responding, (2) a listing of
existing studies that satisfy generic data requirements and (3) a
bibliography of the generic studies EPA has reviewed.
C. The Reregistration Process
Reregistration involves a thorough review of the scientific
data base underlying a pesticide’s registration. The purpose of
EPA’S review is to reassess the potential hazards arising from the
currently registered uses of the pesticide, to determine whether
the data base is substantially complete or there is need for
additional generic data, and to determine whether the pesticide is
1 EPA’s science reviews and information on the registered
uses considered for EPA’s analyses may be obtained from: EPA,
Freedom of Information, 401 )1 St., S.W, Washington, D.C. 20460.
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If the RED declares that some or all uses of the chemical are
eligible for reregistration, affected registrants must first
respond within 90 days of receipt to the data call—in portion of
the RED. Within 8 months of receiving the RED, registrants must
submit or cite any data and labels/labeling required for each
product. EPA has until 14 months after the RED is issued (i.e.,
6 months after the registrants’ 8 month deadline) to review the
submission for each product and decide whether to reregister it
based on the following criteria:
--whether all of the product specific data and labels/labeling
are acceptable,
--whether all of the uses on the label/labeling are eligible,
-—whether all of the active ingredients in the product are
eligible, and
--if no List 1 toxic inert ingredient is contained in the
product (a List 1 inert is permitted only if all data
for it have been submitted and EPA determines
that the inert does not pose any unreasonable adverse
effects in that product).
Products which meet all of these criteria will be
reregistered. Products which do not meet all of these criteria,
but which have acceptable product specific data and labeling, will
be processed as amendments in order to implement label changes
required by the RED.
II. INSTRUCTIONS FOR RESPONDING
A. How and When to Respond
This section provides directions for submitting timely and
adequate responses necessary to reregister products containing the
active ingredient covered by the RED. Registrants must follow
these steps exactly to avoid suspension of their products. All
products containing the active ingredient in the RED (i.e.,
manufacturing use products, end use products and special local need
(SLN or Section 24c) registrations] are subject to the requirements
of the RED. Figure 1 summarizes how and when to respond to the
RED. A step-by-step explanation follows.
SteD 1. Are ExDedited Label Changes Reauired ? In some
instances, EPA may conclude that certain changes to product
labels/labeling must be implemented rapidly. If the RED requires
expedited label/labeling changes, registrants must submit the items
below by the deadline specified in the RED. If expedited label
changes are not required, go to Step 2. -
a. Applicatioh for Registration (EPA Form 8570-1). Complete
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and sign the form. In Section II, insert the phrase “Expedited
Amendment in Response to the Reregistration Eligibility Document
for (insert case name for chemical).” Applications for expedited
label changes will be processed as applications for amended
registration. Use only an original application form with a red
identifier number in the upper right-hand corner.
b. Five (5) copies of revised draft label and labeling.
Refer to the RED for label/labeling changes and follow the
instructions in Section III.C. arid the Appendix of this Handbook
for revising the label and labeling for each product.
Step 2. Are data reauired ? If the RED requires generic or
product specific data, you must follow the directions in the data
call-in notice in the RED. All registrants must respond for all
products within 90 days of receipt: products for which an adequate
response is not received on time will be subject to suspension.
time extensions will be given for responding within 90 days.
Step 3. Are Uses of a Pesticide Eligible for Reregistration ?
If any uses of the active ingredient(s) covered by the RED are
eligible for reregistration, follow these instructions. If uses
are eligible, further response may be needed (see page 5).
EPA’S decision on the eligibility of each of the uses of the
active ingredient(s) is presented in the RED. If any uses of a
chemical are eligible for reregistration, registrants for
manufacturing-use products (MPs), end-use products (EP5) and
special local needs registrations (SLN5), must submit the items
below for each Product within 8 months of the date of issuance of
the RED:
a. Application for Reregistration (use EPA For n 8570-1).
Complete and sign the form. In Section II of that form, check the
box “Other” and insert the phrase “Application for Reregistration.”
Use only an original application form with a red identifier number
in the upper right-hand corner.
b. Five (5) copies of revised draft label and labeling.
Refer to the RED for labeling changes specific to the active
ingredient, follow the instructions in Section III.C. of this
Handbook and refer to the Appendix of this Handbook for guidance on
current requirements for labels and labeling. If there are
ineligible uses on the label or labeling, you may delete such uses
and avoid all requirements and consequences which may be associated
with ineligible uses (e.g, generic data requirements, cancellation,
suspension, etc.). If you delete certain uses now and those uses
become eligible for reregistration later, you must submit an
amendment application to add those uses back to the label.
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FIGURE 1. HOW AND WHEN TO RESPOND TO THE REREGISTRATION
ELIGIBILITY DOCUMENT (RED) FOR MANUFACTURING USE
PRODUCTS (MPs), END-USE PRODUCTS (EPS) and SPECIAL
LOCAL NEEDS REGISTRATIONS (SLN5).
STEP 1: Are expedited label revisions required?
Yes ,7” No
Submit application
and labels on
expedited schedule
specified in RED.
STEP 2: Are data required?
Yes ,7 No
Submit forms within
90 days for generic
and product specific
data.
STEP 3: Are any of the uses on the label
eligible for reregistration?
Yes j, No
Are any uses on the label
ineligible for reregistration?
Yes No
Do you wish to
delete ineligible
uses from label?
For each NP & EP For each HP & EP No further response
& SLN (240) submit & SLN (24c) submit necessary. Await
application within application within the outcome of
8 months. If 8 months. If EPA’S review.
the submission the submission
is acceptable, is acceptable,
the label will be the label will be
stamped accepted stamped accepted
as an amendment. and a notice of
jQ reregistration reregistration
will be issued. will be issued.
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c. Product Specific Data. You must follow the instructions
in the Data Call-In Notice in the RED and in Section III of this
Handbook. Responses to the data call in are due within 90 days of
receipt of the RED and submission or citation of data is due within
8 months of the issuance of the RED.
d. Two (2) copies of the current Confidential Statement of
Formula (EPA Form 857 0-4, revised February 85). Two completed and
signed CSF forms must be submitted for the basic formulation and
for each alternate formulation. If CSFS are not provided for the
alternate formulas, they will not be reregistered and will no
longer be acceptable. The Appendix of this Hahdbook has specific
instructions for completing the CSF form.
e. Certification With Respect to Citation of Data (EPA Form
8570-31). This form must be completed, signed and submitted for
each product to assure that the data compensation provisions of
FIFRA are met.
B. When No Response is Needed
If no uses of a pesticide are eligible for reregistration, it
is unlikely that you will be required to submit product specific
data or labeling. Uses of an active ingredient may be declared
ineligible for reregistration for two possible reasons:
-—Available data indicate that one or more of the criteria for
an in-depth special review have been met;
--Additional generic data are required.
In the first instance, if the active ingredient is placed into
special review, reregistration activities associated with those
uses of the chemical are stopped until EPA makes a final
determination. At that time, EPA will indicate which uses may be
eligible for reregistratiolk and which uses are to be cancelled. If
some or all of the previously ineligible uses become eligible for
reregistration, EPA will start the reregistration process for
products containing only eligible uses.
In the second instance, based upon the review of studies for
an active ingredient during reregistration, additional generic data
(e.g., second- or third-tier studies) may be needed (see the RED).
In such cases, the chemical’s uses will not be eligible for
reregistration until the additional generic data have been
submitted to and reviewed and found acceptable by EPA. If the data
are reviewed and found to be acceptable, EPA will indicate which
uses will be eligible for reregistration and will initiate
reregistration of products containing previously ineligible uses.
If the data are not submitted, products containing the active
ingredient may be suspended.
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C. Where to Respond
By U.S. Mail:
Document Processing Desk (insert distribution code)
Office of Pesticide Programs (H7504C)
Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460—0001
By express mail or by hand delivery:
Document Processing Desk (insert distribution code)
Office of Pesticide Programs (H7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, VA 22202
These mailing addresses and the following distribution codes
must be used to assure the timely receipt and processing of your
submissions. Not using them may significantly delay the handling
of your submissions:
RED-SRRD-xxx (where xxx is the case code given on the front of
the RED)--use this distribution code for all responses pertaining
to or containing generic data . Such responses include the 90-day
response forms for generic data or hard copies of generic data.
RED-RD-PMxx (where xx is the Product Manager team number)--
use this distribution code for all responses pertaining to or
containing product specific data or labeling . Such responses would
include expedited labeling amendments, 90-day responses to product
specific data requirements, hard copies of product specific data
and applications for reregistration.
III. SUBMISSION OF DATA AND LABELS/LABELING
This section provides additional instructions concerning
responses required for generic data, product specific data and
labels/labeling.
A. Generic Data
During EPA’s evaluation of an active ingredient for
reregistration, additional generic data requirements may be
identified that registrants must fulfill. In some instances these
data requirements would have to be satisfied before an active
ingredient or some of its uses could be declared eligible for
reregistration. In other cases, these new data requirements would
not affect the eligibility of the active ingredient, but would be
necessary to confirm EPA’s assessment of that chemical.
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Any new data requirements and how they affect reregistration
eligibility of a chemical are discussed in the RED. If new generic
data requirements are imposed in a Data Dali-In Notice in the RED,
registrants must respond as described in that Notice. The RED also
contains instructions for completing these forms, a citation of
EPA’s legal authority for requiring the new data, a listing of
options available to registrants for satisfying the data
requirements and the name of the contact person for inquiries.
B. Product Specific Data
Product specific data may be required for the reregistration
of each pesticide product in three areas-—product chemistry, acute
toxicity and efficacy.
1. Product Chemistry
Following are instructions for submitting product-specific
data and a discussion of EPA’s policy on inert ingredients.
a. Data
All data requirements for MPs, EPs and SLNs (24c’s) are
specified in the Data Call-In Notice in the RED. In addition:
--If you cite data from another identical, registered
product, you must identify the EPA registration number of that
product.
--If the product-specific data submitted or cited do not
pertain to an identical formulation to the product submitted for
reregistration, then new product-specific data are required to be
submitted by the deadline specified in the Data Call-In Notice.
The only exception is for products which EPA “groups” together a
being similar enough to depend on the same data. Such groupings
are discussed in the appendix to the RED (for acute toxicity
purposes, for example), if it was feasible to do so.
b. Inert In redients
EPA has implemented a strategy for regulating inert
ingredients which affects the reregistration of pesticide products.
This strategy, issued on April 22, 1987 (52 FR 13305—13309) and
updated on November 22, 1989 (54 FR 48314-48316), adopted certain
policies designed to reduce the potential for adverse effects from
pesticide products containing intentionally added inert
ingredients. EPA divided the known inert ingredients into four
categories:
—-Inerts of toxicological concern (List 1) for which available
data demonstrate toxic effects of concern (includes about 50
chemicals).
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-—Potentially toxic inerts (List 2) for which only limited
data are available, but such data or the chemical-structure suggest
the potential for toxicity (includes about 60 chemicals).
--Inerts of unknown toxicity (List 3) for which no data or
bases for suspecting toxic effects are available (includes up to
2,000 chemicals).
--Inerts of minimal concern (List 4) which are generally
regarded as innocuous (includes about 290 chemicals).
When a RED is issued and any uses of an active ingredient are
declared eligible for reregistration, all products containing that
active ingredient will be subject to reregistration. EPA will, as
part of the reregistration review, examine the inert ingredients of
each product prior to reregistration to ensure that they do not
present unreasonable risks. In reviewing the product chemistry
data, EPA will identify List 1 inerts. EPA will continue to
encourage registrants to eliminate any List 1 inerts present.
Reregistration of products containing only List 2, 3 or 4 irierts
will be unaffected by the inerts strategy.
Consistent with the strategy on inerts, a product containing
a List 1 inert ingredient will not be reregistered until a full
risk assessment of the product has been conducted, based on the
data called in for that inert ingredient. However, the existing
registration of a product containing a List 1 inert will remain
valid as long as the product bears the required label warning and
is in compliance with any outstanding DCI, or other activity under
the inerts strategy.
Any product containing a List 2, 3 or 4 inert may be
reregistered j it meets all other requirements for reregistration.
As the inerts strategy is implemented and data for the List 2 and
3 inerts are reviewed, EPA may move these inerts to the other
Lists. If an inert were moved to List 1, products containing that
inert would become ineligible for reregistration. Inert
ingredients must also meet normal registration and tolerance
requirements, as applicable.
2. Acute Toxicity
The data call-in notice in the RED specifies the acute
toxicity data required for reregistration of each MP or EP. It
indicates whether any of the standard tests have been waived and,
if so, why.
If feasible, EPA will “batch” products that are similar with
respect to their acute toxicity so that one set of tests can
support reregistration of each baatch of products. This approach
will impose the least amount of testing-necessary to adequately
support the registration and labeling for pesticide products. The
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main benefits of this approach are to minimize the need for animal
testing, reduce the expense to registrants to generate the tests
and decrease the resources EPA must spend on reviewing data.
Registrants may contact other registrants with products in the same
“batch” to decide whether to provide or depend on one set of data;
alternatively, registrants may choose to conduct their own studies.
3. Product Performance
Consult the Data Call-In section of the RED to determine
whether Product Performance data are required, for your product.
Product performance (efficacy) data are generated in studies
designed to document how candidate pesticide formulations perform
as pest control agents. These data include tests run to determine
whether a formulation is lethal to certain pest species, to
document the effectiveness of the formulation in controlling pest
species in actual use situations, and to determine whether certain
claims beyond mere control of a pest (e.g., “six-month residual
effect,” “kills Warfarin resistant house mice,” etc.) are
justified.
EPA has standard protocols for certain efficacy tests. In
general, standard methods have been developed for tests needed to
substantiate claims that have been made frequently for pesticide
products. As the scope of potential pesticidal claims is extremely
broad, the Agency does not have standard methods for tests needed
to substantiate many pesticide claims, especially those that are
uncommon. The Product Performance Guidelines, Subdivision G, offer
general guidance for developing protocols for efficacy testing.
Proposed protocols should be submitted to EPA for review before
tests are initiated.
a. Efficacy Data Submission Waiver Policy
FIFRA gives the Administrator of EPA authority “to waive data
requirements pertaining to efficacy” but does not require that
efficacy data requirements be waived for any class of pesticide
product registered under Section 3 of the Act. As a matter of
policy, EPA does not require submission of efficacy data to support
many types of pesticidal claims but does require subnUssion of such
data for certain types of claims. As noted in 40 CFR 158.640, this
waiver applies to the submission of efficacy data rather than to
the generation of efficacy data. EPA expects each registrant to
“ensure through testing that his products are efficacious when used
in accordance with commonly accepted pest control practices.”
This general policy notwithstanding, EPA may, at any time,
require a registrant to submit efficacy data to support any claim
made for a product. EPA also may require that certain claims of
effectiveness be established before a Section 3 registration is
granted.
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b. Claims and Products for Which Efficacy Data Generally
Are Required
Submission of efficacy data at reregistration typically is
required for the following types of products:
1. products claimed to control microorganisms that
pose potential threats to public health;
2. products claimed to control vertebrate pests that
may directly or indirectly transmit diseases to
humans;
3. potentially very hazardous products for which EPA
determines that it is necessary to conduct a “risk—
benefits” analysis;
4. products of types for which EPA has reasons (e.g.,
consumer complaints, unlikely claims, unusual use
patterns, etc.) to question claims; and
C. Labels and Labeling
To remain in compliance with FIFRA, the label and labeling of
each product must be revised to meet the requirements for
reregistration as described below. “Labeling” includes the
container label and any written, printed or graphic matter that
accompanies the pesticide in U.S. commerce at any time (such as
technical bulletins, collateral labeling, etc.). Applications for
new uses or labeling changes that do not pertain to reregistration
must be filed separately from the application for reregistration
described in Step 3 earlier. Changes to labeling which must be
made for reregistration include, but are not limited to:
1. Labeling changes specified in the RED. Such changes may
include statements on RESTRICTED USE, groundwater hazards,
protective clothing/equipment, endangered species, environmental
hazards, etc.
2. The format and content of labeling as described in 40 CFR
156.10. When further acute testing is needed, the currently
accepted precautionary statements will usually be retained until
testing is completed and the data are reviewed.
3. Labeling changes required by Pesticide Regulatory (PR)
Notices, regulations, regulatory decisions and policies issued by
EPA which are relevant to the pesticide. Your product’s labeling
must reflect any applicable requirements which are in effect at the
time the RED is issued. Some existing notices are referred to in
Section B. of the Appendix.
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APPENDIX
A. Confidential Statement of Formula and Instructions
B. Instructions for Label Contents
C. Sample Label Formats--General Use & Restricted Use
D. Label Regulations (40 CFR 156.10)
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Confidential Business Information: Does Not Contain National Securit In formation (E. 0. 12065)
Office of Pesticide Programs (TS-767)
United States Environmental Protection Agency
E Washington. DC 20460
Confidential Statement of Formula
Form Approved. 0MB No. 2070-0060. Approval expires 9-30-90
A. Basic Formulation I B.
0
Ses Instructions on
1. Name and Address of Applicant/Registrant (Include ZIP Code)
Alternate Formulation I Page of
2. Name and Address of Producer (Include ZIP Code)
3. Product Name
4. Registra i No/File Symbol I EPA Product Mgr/Team No.
6. Country Where Formulated
I
7. Pounds/Gal or Bulk Density I 8. p11
9. Flash Point/Flame Extension
EPA USE ONLY
10. Components in Formulation (List as actually introduced
into the formulation. Give commonly accepted che.’nical
name. traibnam and C4S number.)
11. Supplier Name & Address
12. EPA Reg. No.
13. Each Component
in Formulation
a. Amount b. S y i
14. Certified Limits
S Weigtn
a. Up Limif b Loser Urn’
15. Purpose in
Formulation
16. Typed Name of Approving Official 17. Total Weight
100%
18. Signature of Approving Official 119. Title 20. Phone No. (Include Area Code 1 ii. —
EPA Form 8570-4 (Rev. 2-85) Previous
Original and second copy to EPA.
Third copy to Applicant
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Instructions for Completing the Confidential Statement of
Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must
be used. Two legible, signed copies of the form are required.
Following are basic instructions:
a. All the blocks on the form must be filled in and answered
completely.
b. If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of
the responsible party must be provided.
d. All applicable information which is on the product-
specific data submission must also be reported on the CSF.
e. All weights reported under item 7 must be in pounds per
gallon for liquids and pounds per cubic feet for solids.
f. Flashpoint must be in degrees Fahrenheit and flame
extension in inches.
g. For all active ingredients, the EPA Registration Numbers
for the currently registered source products must be reported under
column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all
actives and inerts and all common names for the trade names must be
reported.
i. For the active ingredients, the percent purity of the
source products must be reported under column 10 and must be
exactly the same as on the source product’s label.
j. All the weights in columns 13.a. and l3.b. must be in
pounds, kilograms, or grams. In no case will volumes be accepted.
Do not mix English and metric system units (i.e.,. pounds and
kilograms).
k. All the items under column 13.b. must total 100 percent.
1. All items under columns 14.a. and ].4.b. for the active
ingredients must represent pure active form.
in. The upper and lower certified limits for all active and
inert ingredients must follow the 40 CFR 158.175 instructions. An
explanation must be provided if the proposed limits are different
than standard certified limits.
n. When new CSFs are submitted and approved, all previously
submitted CSFs become obsolete for that specific formulation.
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B. INSTRUCTIONS FOR LABEL CONTENTS
40 CFR 156.10 and Pesticide Regulatory (P.R.) Notices require
that specific labeling statements appear at certain locations on
the label. The sample label formats in Appendix C show where these
statements are to be placed.
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. (40 CFR 156.10(b)]
Item 2. COMPANY NAME AND ADDRESS - The name and address of the
producer, registrant or person for whom the product is produced are,
required on the label and should be located at the bottom of the
front panel or at the end of the label text. [ 40 CFR 1 6.10(c))
Item 3. NET CONTENTS - A net contents statement is required on all
labels or on the container of the pesticide. The preferred
location is the bottom of the front panel immediately above the
company name and address, or at the end of the label text. The net
contents must be expressed in the largest suitable unit, e.g., “1
pound 10 ounces” rather than “26 ounces.” In addition to English
units, net contents may be expressed in metric units. [ 40 CFR
156.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration number assigned
to the pesticide product must appear on the label, preceded by the
phrase “EPA Registration No.,” or “EPA Reg. No.” The registration
number must be set in type of a size and style similar to other
print on that part of the label on which it appears and must run
parallel to it. The registration number and the required
identifying phrase must not appear in such a manner as to suggest
or imply recommendation or endorsement of the product by the
Agency. [ 40 CFR 156.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment number,
preceded by the phrase “EPA Est.” is the final establishment at
which the product was produced, and may appear in any suitable
location on the label or immediate container. It must also appear
on the wrapper or outside container of the package if the EPA
establishment number on the immediate container cannot be clearly
read through such wrapper or container. [ 40 CFR 156.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement is
normally required on the front panel. The ingredients statement
must contain the name and percentage by weight of each active
ingredient and the total percentage by weight of all inert
ingredients. The preferred location is immediately below the
product name. The ingredients statement must run parallel with,
and be clearly distinguished from, other text on the panel. It
must not be placed in the body of other text. (40 CFR 156.10(g)]
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricultural
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formulations, the pounds per gallon of active ingredient must be
indicated on the label. [ 40 CFR 156.10(h) (iv)]
Item 6C. NAMES TO BE USED IN INGREDIENT STATEMENT - The acceptable
common name, if there is one, shall be used, followed by the
chemical name. If no common name has been established, the
chemical name alone shall be used. Chemicals related to the active
ingredient are allowed to be listed oniy if efficacy data
supporting such claims are submitted or referenced. If such data
are provided, the related chemicals must be listed separately and
not as a portion of the active ingredient.
Item 6D. INERT INGREDIENTS RECLASSIFIED AS ACTIVE INGREDIENTS - If
EPA has reclassified chemicals from inert ingredient status to
active ingredient status, registrants of affected products must
change the ingredient statement accordingly (See 52 FR 13307-8,
April 22, 1987). If such pesticides have food uses, tolerances
must either be established for such uses, or an exemption from the
requirement for tolerances must be obtained.
Item 6E. NOMINAL CONCENTRATION - The amount of active ingredient
declared in the ingredient statement must be the nominal
concentration of the product as defined in 40 CFR 158.153(1) and
described in P.R. Notice 91-2.
Item 7. WARNINGS AND PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label on Signal Word “Keep Out of Reach
Front Panel Minimum Type Size of Children”
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement “Keep Out
of Reach of Children” must be located on the front panel above the
signal word except where contact with children during distribution
or use is unlikely. (40 CFR 156.10(h) (1) (ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING, or
CAUTION) is required on the front panel immediately below the child
hazard warning statement. [ 40 CFR 156.10(h) (1) (i) )•
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Item 7C. SKULL & CROSSBONES AND WORD “POISON” - On products
assigned a toxicity Category I on the basis of oral, dermal, or
inhalation toxicity, the word “Poison” shall appear on the label in
red on a background of distinctly contrasting color and the skull
and crossbones shall appear in immediate proximity to the word
POISON. [ 40 CFR 156.10(h) (1) (i)].
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement of
practical treatment (first aid or other) shall appear on the label
of pesticide products in toxicity Categories I, II, and III. [ 40
CFR 156.10(h) (1) (iii)]
Item 7E. REFERRAL STATEMENT — The statement “see Side (or Back)
Panel for Additional Precautionary Statements” is required on the
front panel for all products, unless all required precautionary
statements appear on the front panel. [ 40 CFR 156 • 10(h) (1) (iii)].
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The precautionary
statements listed below must appear together on the label under the
heading “PRECAUTIONARY STATEMENTS.” The preferred location is at
the top of the side or back panel preceding the directions for use,
and it is preferred that these statements be surrounded by a block
outline. Each of the three hazard warning statements must be
headed by the appropriate hazard title. [ 40 CFR 156.10(h) (2)].
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a hazard
exists to humans or domestic animals, precautionary statements are
required indicating the particular hazard, the route(s) of exposure
and the precautions to be taken to avoid accident, injury or
damage.. [ 40 CFR 156.10(h) (2) (i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to non-
target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of the
hazard and the appropriate precautions to avoid potential accident,
injury, or damage. [ 40 CFR 156.10(h) (2) (ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY Precautionary
statements relating to flammability of a product are required to
appear on the label if it meets the criteria in the PHYS/CHEM
Labeling Appendix. The requirement is based on the results of the
flashpoint determinations and flame extension tests required to be
submitted for all products. These statements are to be located in
the side/back panel precautionary statements section, preceded by
the heading “Physical/Chemical Hazards.” Note that no signal word
is used in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d) requires
that all pesticide formulations/uses be classified for either
general or restricted use. Products classified for restricted use
may be limited to use by certified applicators or persons under
their direct supervision (or may be subject to other restrictions
that may be imposed by regulation). If your product has been
classified for restricted use, then these requirements apply:
-------
1. All uses restricted. The following statements must be placed
in a black box at the top of the front panel of the label and
labeling:
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 tsee table in 40 CFR
156.10(h) (l)(ivfl. No statements of any kind may appear
above this RUP statement.
b. The reason.for the the restricted use classification must
appear below the PUP statement. The RED will prescribe
this statement.
c. A suimnary statement of the terms of restriction must
appear directly below this reason statement on the front
panel. 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.” The RED
will specify what statement must be used.
2. Some but not all uses restricted. If the RED 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 lab el and
submit draft labeling bearing only unrestricted uses.
c. You may “split” your registration, i.e., register two
separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted
simultaneously. Note that the products will be assigned
separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the misuse
statement, “It is a violation of Federal law to use this product in
a manner inconsistent with its labeling.” This statement appears
at the beginning of the directions for use, directly beneath the
heading of that section.
Item bA. REENTRY STATEMENT - If a restricted entry interval (REI)
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 lOB. STORAGE AND DISPOSAL BLOCK - All labels are required to
bear storage and disposal statements. These statements are
developed for specific containers, sizes, and chemical content.
These instructions must be grouped and appear under the heading
“Storage and Disposal” in the directions for use. This heading
must be set in the same type sizes as required for the child hazard
warning. Refer to P.R. Notices 83-3 and 84-]. to determine the
storage and disposal instructions appropriate for your products.
Item bC. DIRECTIONS FOR USE - Directions for use must be stated
in terms which can be easily read and understood by the average
person likely to use or to supervise the use of the pesticide.
When followed, directions must be adequate to protect the publià
from fraud and from personal injury and to prevent unreasonable
advex se effects on the environment. (40 CFR 156.10(i) (2)]
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. Collateral labeling must be made part
of the response to the RED and submitted for review.
-------
PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS
* OOME$TC ANNALS
CAUTION
ENV ONUENTAL HAZARDS
__ PRODUCT _
PHYSICAL OR CNIMICAL ____
HAZARDS ______ -
- — — : t1
___________________ ACTWE P4QREDIENT: _____________ S ____________
OmECTIONS FOO P ERT 140&OIEPITS: — ____________ - o
• _____ - TOTAL: I’ ’ __________________________
tM
RtENThY STATEMENT THIS PAOOUCT CONTMlS LU OF PER GALLON _____
IA Ica) ____
____________ KEEPOIJTOFREACHÔFCIIILDREN -— ____
- - ___ CAUTION -
____ STATEMENT OF PMC TiCAJ. tREA ENT STORAGE AND
____ _________ F SWALLOWED- DISPOSAL
_____ ii FP*IALLO___________________________ ORAGI ________
_____ VON 5KP4 ___________________________ _____________
____ _________ FI4EVE$-_______________________ DISPOSAL—
CROP: = ___________ SEE SIDE PANEL oR ROOmONAa. PRECAUTIONARY STATEMENTS
MFG SY — WARRANTY STATEMENT
TOWN. STATE _________________
ESTASUSHMENT NO. _____________
EPA REGISTRATION NO. __________
-------
I
PRECAUTiONARY 8TATEMEPI1$
HAZARDS TO HUMANS
I DOUESTC ANSIALI
DANGER
tn
(*for example, “Due tohigh acute toxicity.”)
PRODUCT
NAME
• ACTWI lOREV NT: _____________ S
ERT P 0REOtNT8: — S
OmEC11ONS FOR USE
I - I --i b TOTAL 100.00%
1* h S b ri l _ 4
REENTRY STATEMENT TH$ PRO CONTA 5 5 LBS OF PER GALLON
_________ KEEP OUT OF REACH OF CHILDREN
0
t n
c, .J
‘-3
. STORAGE AND
DISPOSAL
F SWALLOWED ____
VMHALED_________ ___
F IN EYES _____________________
SEE PANEL FOR ADOmONAL P CAUTIONARY STATEMENTS
MfO B’
TOWN.
E TAeU3#MENT NO. ____________
EPA REGISTRATION NO. __________
RESTRICTED USE
PESTICIDE
__ Due to (insert reason*)
• ZL ML* R) Mm LBS ØILY IT irt APVUCA I 1*
c m i i i oz r aiplivisicis .
tBSE a D IT TI CEArbIB) APPIJcai ’ IflCATI(J4
PWVSCAL ON c, LI AL
C
STATEMENT OF Pc
CROP:
WARRANTY STATEMENT
NtJ
-------
EnvIr0nmhhI t& Protection Ag.ncy
§ 156.10
binitter has asserted a confidential
sjness information claim concerning
the mater ).
(5) A COPY of each document, propos-
j or other item of written material
0 ncerflIfl the Registration Standard
nrovided by the Agency to any person
or partY outside of government
(within 15 working days after the item
is made available to such person or
partY).
(6) A COPY of the Registration Stand-
ard;
(7) With respect to a Registration
standard for which the Agency has
determined that a substantially com-
plete chronic health and teratology
data base exists, a copy of the FED R .L
REGISTER notice concerning availabil-
ity of a proposed Registration Stand-
ard, and a copy of each comment re-
ceived in response to that notice
(Within 10 working days after receipt
by the Agency, or 15 working days if
the submitter has asserted a confiden-
tial business information claim con-
cerning the material).
(8) A copy of the FEDERAL REGISTER
notice announcing the issuance of the
egIstration Standard (within 10
working days after the publication of
the notice).
c Index of the dockeL The Agency
will establish and keep current an
index to the docket for each Registra-
tion Standard. The index will include,
but Is not limited to:
(1) A list of each meeting between
the Agency and any person or party
outside of government, containing the
date and subject of the meeting, the
names of participants and the name of
the person requesting the meeting.
(2) A list of each document In the
docket by title, source or recipient(s),
and the date the document was re-
ceived or provided by the Agency.
(d) Availability of docket and indi-
ces. (1) The Agency will make avail-
able to the public for Inspection and
copying the docket and Index for any
Registration Standard.
(2) The Agency will establish and
maintain a mailing list of persons who
have specifically requested that they
receive indices for Registration Stand-
ard dockets. On a quarterly basis, EPA
will distribute the Indices of new mate-
rials placed in the public docket to
these persons. Annuaily, E A will re-
quire that persons on the list renew
their requests for inclusion on the list.
(3) The Agency will issue annually in
the FEDERAL REGISTER (in conjunction
with the annual schedule notice speci-
fied in § 155.25) a notice announcing
the availability of docket indices.
(4) Each FEDERAL REGISTER notice of
availability of a Registration Standard
will announce the availability of the
docket index for that Standard.
§ 155.34 Notice of availability.
(a) The Agency will issue in the FED-
ERAL REGISTER a notice announcing the
issuance and availability of Registra-
tion Standard which:
(1) Concerns a previously unregis-
tered active ingredient; or
(2) Concerns a previously registered
active Ingredient, and the Registration
Standard states that registrants will
be required (under FIFRA section
3(c)(2)(B)) to submit chronic health
(including, but not limited to, chronic
feeding, oncogenicity and reproduc-
tion) or teratology studies.
(b) Interested persons may submit
comments concerning any Registra-
tion Standard described by paragraph
(a) of this section at any time.
(c) The Agency will issue in the FED-
ERAL REGISTER a notice announcing the
availability of, and providing opportu-
nity for comment on, each proposed
Registration Standard which concerns
a previously registered active ingredi-
ent for which the Agency has deter-
mined that a substantially complete
chronic health and teratology data
base exists. Following the comment
period and Issuance of the Registra-
tion Standard, the Agency will Issue in
the FEDERAL REGISTER a notice of avail-
ability of the Registration Standard.
PART 156—LABEUNG REQUIRE-
MENTS FOR PESTICIDES AND DE-
VICES
AUThoRITY: 7 U.S.C. l36-136y.
§ 156.10 Labeling requirements.
(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-
75
-------
§ 156.10
40 CFR Ch. I (7-1-89 EdItIon)
lations in this Part. The contents of a
label must show clearly and prom!-
nently the following:
(I) The name, brand, or trademark
under which the product is sold as pre-
scribed in paragraph (b) of this sec-
tion;
(ii) The name and address of the
producer, registrant, or person for
whom produced as prescribed in para-
graph (C) of this section;
(iii) The net contents as prescribed
in paragraph (d) of this section;
(iv) The product registration
number as prescribed in paragraph (e)
of this section;
(v) The producing establishment
number as prescribed in paragraph (f)
of this section;
(vi) An ingredient statement as pre-
scribed in paragraph (g) of this sec-
tion;
(vii) Warning or precautionary state-
ments as prescribed In paragraph (h)
of this section;
(vifi) The directions for use as pre-
scribed In paragraph (I) of this section;
and
(Ix) The use classification(s) as pre-
scribed in paragraph (j) of this section.
(2) Prominence and legibility. (I) All
words, statements, graphic representa-
tions, designs or other information re-
quired on the labeling by the Act or
the regulations In this part must be
clearly legible to a person with normal
vision, and must be placed with such
conspicuousness (as compared with
other words, statements, designs, or
graphic matter on the labeling) and
expressed in such terms as to render it
likely to be read and understood by
the ordinary individual under custom-
-ary conditions of purchase and use.
(ii) All required label text must:
(A) Be set in 6-point or larger type;
(B) Appear on a clear contrasting
background; and
(C) Not be obscured or crowded.
(3) Language to be used. All required
label or labeling text shall appear in
the English language. However, the
Agency may require or the applicant
may propose additional text in other
languages as Is considered necessary to
protect the public. When additional
text In another language Is necessary,
all labeling requirements will be ap-
plied equally to both the English and
other-language versions of the labej.
lug.
(4) Placement of Label—(i) General,
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-
branding 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 m i-
mediate container is enclosed within a
wrapper or outside container through
which the label cannot 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 package as
customarily distributed or sold.
(ii) Tank cars and other bulk con-
tainers—(A) Transportation. While a
pesticide product is In transit, the ap-
propriate provisions of 49 CFR Parts
170-189, concerning the transportation
of hazardous materials, and specifical-
ly those provisions concerning the la.
beling, marking and placarding of haz-
ardous materials and the vehicles car-
rying them, define the basic Federal
requirements. In addition, when any
registered pesticide product is trans-
ported in a tank car, tank 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 time
of delivery.
(B) Storage. 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.
(5) False or misleading statements.
Pursuant to section 2(q)(1)(A) of the
Act, a pesticide or a device declared
sub ject to the Act pursuant to
§ 153.240, is misbranded if its labeling
Is false or misleading In any particular
including both pesticidal and non-pes-
ticidal claims. Examples of statements
or representations In the labeling
which constitute misbranding include:
(i) A false or misleading statement
concerning the composition of the
product;
76
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I,onm.ntaI Prot.ctlon Ag.ncy
§ 156.10
(U) A faise or misleading statement
cern1ng the effectiveness of the
r rodUCt 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-
ment;
(vi) The name of a pesticide which
contains two or more principal active
ingredients if the name suggests one
or more but not all such principal
active ingredients even though the
names of the other ingredients are
stated elsewhere in the labeling;
(vii) A true statement used in such a
way as to give a false or misleading Im-
pression to the purchaser;
( lll) Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions;
(ix) Claims as to the safety of the
pesticide or its ingredients, including
statements such as “safe,” “nonpoison-
ous,” “noninjurlous,” “harmless” or
“nontoxic to humans and pets” with
or without such a qualifying phrase as
“when used as directed”; and
(x) Non-numerical and/or compara-
tive statements on the safety of the
product, including but not limited to:
(A) “Contains all natural Ingredi-
ents”;
(B) “Among the least toxic chemi-
cals known”
(C) ‘Pollution approved”
(6) Final printed labeling. (I) Except
as provided In paragraph (a)(6X11) of
this section, fInal printed labeling
must be submitted and accepted prior
to registration. However, final printed
labeling need not be submitted until
draft label texts have been provision-
ally accepted by the Agency.
(Ii) Clearly legible reproductions or
photo reductions will be accepted for
unusual labels such as those silk-
screened directly onto glass or metal
containers or large bag or drum labels.
Such reproductions must be of micro-
film reproduction quality.
(b) Name, brand, or trade iarlc. (1)
The name, brand, or trademark under
which the pesticide product is sold
shall appear on the front panel of the
label.
(2) No name, brand, or trademark
may appear on the label which:
(1) Is false or misleading, or
(ii) Has not been approved by the
Administrator through registration or
supplemental registration as an addi-
tional name pursuant to § 152.132.
(c) Name and address of producer,
registrant, or person for whom pro-
duced. An unqualified name and ad-
dress given on the label shall be con-,
sidered as the name and address of the
producer. If the registrant’s name ap-
pears on the label and the registrant Is
not the producer, or if the name of the
person for whom the pesticide was
produced appears on the label, it must
be qualified by appropriate wording
such as “Packed fore • a,” “Distribut-
ed by * * ,“ or “Sold by * * a,, to show
that the name is not that of the pro-
ducer.
(d) Net weight or measure of con-
tents. (1) The net weight or measure
of content shall be exclusive of wrap-
pers or other materials and shall be
the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide is a liquid, the
net content statement shall be In
terms of liquid measure at 68 F (20C)
and shall be expressed in conventional
American units of fluid ounces, pints,
quarts, and gallons.
(3) If the pesticide is solid or semi-
solid, viscous or pressurized, or is a
mixture of liquid and solid, the net
content statement shall be in terms of
weight expressed as avoirdupois
pounds and ounces.
(4) In all cases, net content shall be
stated in terms of the largest suitable
units, i.e., “1 pound 10 ounces” rather
than “26 ounces.”
(5) In addition to the required units
specified, net content may be ex-
pressed In metric units.
(6) Variation above minimum con-
tent or around an average Is per’nIssI-
ble only to the extent that It repre-
sents deviation unavoidable In good
manufacturing practice. Variation
below a stated minimum Is not permit-
ted. In no case shall the average con-
77
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§ 156.10
40 CFR C I ’. I (71-89 EdItion)
tent of the packages In a shipment fall
below the stated average content.
(e) Product registration number.
The registration number assigned to
the pesticide product at the time of
registration shall appear on the label,
preceded by the phrase “EPA Regis-
tration No.” or the phrase “EPA Reg.
No.” The registration number shall be
set in type of a size and style similar to
other print on that part of the label
on which it appears and shall run par-
allel to it. The registration number
and the required identifying phrase
shall not appear in such a manner as
to suggest or imply recommendation
or endorsement of the product by the
Agency.
(f) Producing establishments regis-
tration number. The producing estab-
lishment registration number preced-
ed by the phrase “EPA Est.”, of the
final establishment at which the prod-
uct was produced may appear In any
suitable location on the label or Imme-
diate container. It must appear on the
wrapper or outside container of the
package If the EPA establishment reg-
istration number on the immediate
container cannot be clearly read
through such wrapper or container.
(g) Ingredient statement—(1) Gener-
al. The label of each pesticide product
must bear a statement which contains
the name and percentage by weight of
each active Ingredient, the total per-
centage by weight of all Inert Ingredi-
ents: and if the pesticide contains ar-
senic in any form, a statement of the
percentages of total and water-soluble
arsenic calculated as elemental ar-
senic. The active Ingredients must be
designated by the term “active ingredi-
ents” and the Inert Ingredients by the
term “inert Ingredients,” or the singu-
lar forms of these terms when appro-
priate. Both terms shall be in the
same type size, be aligned to the same
margin and be equally prominent. The
statement “Inert Ingredients, none” Is
not required for pesticides which con-
tain 100 percent active ingredients.
Unless the ingredient statement Is a
complete analysis of the pesticide, the
term “analysis” shall not be used as a
heading for the ingredient statement.
(2) PosIt Ion of Ingredient statement.
(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 Canflot be clearly
read, the ingredient statement must
also appear on such outside container
or wrapper. If the size or form of the
package makes it impracticable to
place the ingredient statement on the
front panel of the label, permission
may be granted for the ingredient
statement to appear elsewhere,
(II) The text of the ingredient state-
ment must run parallel with other
text on the panel on which It appears,
and must be clearly distinguishable
from and must not be placed in the
body of other text.
(3) Names to be used in ingredient
statement. The name used for each in-
gredient shall be the accepted
common name, If there is one, fol-
lowed by the chemical name. The
common name may be used alone only
if it Is well known. If no common name
has been established, the chemical
name alone shall be used. In no case
will the use of a trademark or proprie-
tary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of section 25(c)(6).
(4) Statements of percentages, The
percentages of ingredients shall be
stated in terms of weight-to-weight.
The sum of percentages of the active
and the inert thgred1en shall be 100.
Percentages shall not be expre sed by
a range of values such as “22-25%.” If
the uses of the pesticide product are
expressed as weight of active ingredi-
ent per unit area, a statement of the
weight of active ingredient per unit
volume of the pesticide formulation
shall also appear in the ingredient
statement.
(5) Accuracy of stated percentages.
The percentages given shall be as pre-
cise as possible reflecting good manu-
facturing practice. If there may be uii-
avoidable variation between manufac-
turing batches, the value stated for
each active ingredient shall be the
lowest percentage which may be
present.
(6) Dete,jorat ion. Pesticides which
change in chemical composition sig-
nificantly must meet the following la-
beling requirements:
78
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1 nm.ntal Prot.cflen Agency
* 156.10
j in cases where it is detennlned
$ pesticide formulation changes
emic$l composition significantly,
C::e product must bear the following
ttement In a prominent position on
e label: “Not for sale or use after
(date].
jj The product must meet all label
claims up to the expiration time mdi-
cated Øfl the label.
(7) Inert ingredients. The Adminis-
trator may require the name of any
jnert Ingredient(s) to be listed In the
red1ent statement if he determines
that such ingredient(s) may pose a
hazard to man or the environment.
(b) Warnings and precautionary
statements. Required warnings and
precautionarY statements concerning
the general areas of tQ )I 4 Sj
hMard 1nclu4li g hazard to. . IJ n ,
enWonmentsl hazard, and p áj or
c) rnIóaj hazard fall Into t
those required on the front en of
the labeling and those which may
appear elsewhere. Specific require-
ments concerning content, placement,
type size, and prominence are given
below.
(1) Required front panel statements.
With the exception of the child
hazard warning statement, the text re-
quired on the front panel of the label
Is determined by the Toxicity Catego-
ry of the pesticide. The category is as-
signed on the basis of the highest
hazard shown by any of the Indicators
in the table below:
Toxicity Catsgoflea
(I) Human hazard signal word—(A)
Toxicity Category I. AU pesticide prod-
ucts meeting the criteria of Toxicity
Category I shall bear on the front
panel the signal word “Danger.” In ad-
dition if the product was assigned to
Toxicity Category I on the basis of Its
oral, inhalation or dermal toxicity (as
distinct from skin and eye local ef-
fects) the word “Poison” shall appear
In red on a background of distinctly
contrasting color and the skull and
crossbones shall appear In hnn edIate
proximity to the word “poison.”
(B) Toxicity Category II. All pesti-
cide products meeting the criteria of
Toxicity Category II shall bear on the
front panel the signal word “Warn-
Iflg
(C) Toxicity Category 111. All p stI-.
dde products meeting the crite la of
Toxicity Category III shall bear on
the front Panel the signal word “Cau-
tion.”
(D) Toxicity Category IV. All pesti-
cide products meeting the criteria of
Toxicity Category IV shall bear on the
front panel the signal word “Caution.”
(E) Use of signal words. Use ófiny
signal word(s) associated with a higher
Toxicity Category is not permitted
except when the Agency determines
that such labeling is necessary to pre-
vent unreasonable adverse effects on
man or the environment. In no case
shall more than one hum h’ wd
signal word appear on the front panel
of a label.
(II) Child hazan’t warning. Every pes-
ticide product laoel ah.il bear on the
front panel the statement “keep out of
re of children.” Only In, oases
z re the likelihood of oozitam with
cbfldreij during distribution, ma*et-
Ing, storage or use Is demonstrated by
the applicant to be extremely remote,
or if the nature of the pesticide Is such
I II
Ill lv
rt LD ..
Up to and includIng 50
mg/kg.
From 50 thru 500 mg/kg..
From 500 thru 5000 mg/
Greater than 5000 mgI
i gistion LCS.
Up to and includIng .2
mg/liter.
From .2 thru 2 mg/liter
kg.
From 2. thru 20 mgIIit.r...
kg.
Gr.ater than 20 mg/lIter.
Deflfl& W. .
Up to and includIng 200
mg/kg.
From 200 thru 2000
From 2,000 thru 20.000....
Greater than 20,000.
Eye effects
Corrosive; co4’neai
opacity not reversible
within 7 days.
Comsal opacity
revsrsibis withIn 7
days; irritation
persisting for 7
No comeal opacity;
irritatIon reversible
withIn 7 days.
No irrItation.
.,
sicin elf acts
Corrosive
days.
Sever. Irritation at 72
hours.
Moderat. irritation at 72
hours.
.
MIkI or slight *rltabon at
72 hours.
79
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§ 156.10
ti at it Is approved for use on Infants
or small children, may the Administra-
tor waive this requirement.
(ill) Statement of practical treat-
,nent—(A) Toxicity Category I. A
statement of practical treatment (first
aid or other) shall appear on the front
panel of the label of all pesticides fall-
ing Into Toxicity Category I on the
basis of oral, inhalation or dermal tox-
icity. The Agency may, however,
permit reasonable variations In the
placement of the statement of practi-
cal treatment is some reference such
as “See statement of practical treat-
ment on back panel” appears on the
front panel near the word “Poison”
and the skull and crossbones.
(B) Other toxicity categories. The
statement of practical treatment is not
required on the front panel except as
described In paragraph (h)(1)(iii)(A) of
this section. The applicant may, how-
ever, Include such a front panel state-
ment at his option. Statements of
practical treatment are, however, re-
quired elsewhere on the label in
accord with paragraph (h)(2) of this
section if they do not appear on the
front panel.
(iv) Placement and prominence. All
the require front panel warning state-
ments shall be grouped together on
the label, and shall appear with suffi-
cient prominence relative to other
front panel text and graphic material
to make them unlikely to be over-
looked under customary conditions of
purchase and use. The following table
shows the minimum type size require-
40 CFR Ch. I (7-149 EdItIOn)
ments for the front panel warn1x
statements on various sizes of labels:
Size of label front panel In square
jnrhes
Points
Required
“ •I
‘
capitals
..
of reach
C ren
5andunder
Above 5 to 10
Above l0to l5
Abovs l5to30
Over 30
6
10
12
14
18
8
6
B
10
12
(2) Other required warnings and pre-
cautionary statements. The warnings
and precautionary statements as re-
quired below shall appear together on
the label under the general heading
“Precautionary Statements” and
under appropriate subheadings of
“Hazard to Humans and Domestic Ani-
mals,” “Environmental Hazard” and
“Physical or Chemical Hazard.”
(i) Hazard to humans and domestic
animals. (A) Where a hazard exists to
humans or domestic animals, precau-
tionary statements are required indi-
cating the particular hazard, the
route(s) of exposure and the precau-
tions to be taken to avoid accident,
injury or damage. The precautionary
paragraph shall be immediately pre-
ceded by the appropriate hazard signal
word.
(B) The following table depicts typi-
cal precautionary statements. These
statements must be modified. or ex-
panded to reflect specific hazards.
Toxicity
category
Prscautlonaty statements by toxicity category
Oral Inhalation, or dsrmal toxicity
Skin and eye local effects
Fatal (poisonous) If swallowed (inhaled or absorbed
through skin). Do not breathe vapor (dust or spray
mist). Do not get In eyes, on skin, or on clothing
(Front panel statement of practical tr.atment re.
quired.].
Corrosive causes eye and skin damage (or skin
Irrit ation). Do not get In eyes, on skin, or on
clothing. Wear goggles or face shield and rubber
gloves when handling. Harmful or fatal If swallowed.
(Appropriate first aid statement required.)
I I
May be fatal If swallowed (inhaled or absorbed
through the skin]. Do not breathe vapors (dust or
spray mist]. Do not get In eyes, on skin, or on
clothIng. (Appropriate first aid statements required.).
Causes eye (and skin) irritation. Do not get in eyes,
on skin, or on clothing. Harmful If swallowed. (Ap-
propriate first aid statement required.)
Ill
Harmful If swallowed (Inhaled or absorbed through the
Avoid contact with skin, eyes or clothing. In ass. of
skin]. Avoid breathIng vapors (dust or spray mist).
Avoid contact with skin (eyes or clothing]. (Appro-
pflats first aid statement required.).
contact immediately flush y.s or skin with plenty of
water. Get medical attention If Irritation persists.
IV
(No prscautlonavy statements required.)
(No precautionary statements required.)
80
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Prof.ctlon Ag.ncy
0) Zflvironmental ha.eards. Where a
e ts to non target organisms
c1ud humans and domestic ani-
ais, precautionMY statements are re-
ulr stating the nature of the
and the appropriate precau-
tIo avoid potential accident,
r damage. Examples of the
statements and the circum-
3flC under which they are required
follow:
(A) If a pesticide Intended for out-
door use contains an active ingredient
lth a mamm Uan acute oral LD of
iOO or less, the statement “This Pesti-
Is Toxic to Wildlife” is required.
(B) If a pesticide intended for out-
door use contains an active ingredient
with a fish acute LC. of 1 ppm or less,
t e statement “This Pesticide Is Toxic
to Fish” is required.
(C) If a pesticide intended for out-
door use contains an active Ingredient
itb an avian acute oral LD of 100
ag/kg or less, or a subacute dietary
D Directions for Use—(l) General
requirements—(i) Ad,equacij and clar-
ity of directions. Directions for use
must be stated In terms which can be
easily read and understood by the av-
erage person likely to use or to super-
vise the use of the pesticide. When fol-
lowed, directions must be adequate to
protect the public from fraud and
from personal injury and to prevent
unreasonable adverse effects on the
environment.
§ 156.10
LC.. of 500 ppm or less, the statement
“This Pesticide is Toxic to Wildlife” is
required.
(D) If either accident history or field
studies demonstrate that use of the
pesticide may result In fatality to
birds, fish or mammals, the statement
“This pesticide Is extremely toxic to
wildlife (fish)” Is required.
(E) For uses involving foliar applica-
tion to agricultural crops, forests, or
shade trees, or for mosquito abate-
ment treatments, pesticides toxic to
pollinating insects must bear appropri-
ate label cautions.
(F) For all outdoor uses other than
aquatic applications the label must
bear the caution “Keep out of lakes,
ponds or streams. Do not contamiziate
water by cleaning of equipment or dis-
posal of wastes.”
(iii) Physical or chemical hazards.
Warning statements on the flammabil-
ity or explosive characteristics of the
pesticide are required as follows:
(ii) Placement of directions for use.
Directions may appear on any portion
of the label provided that they are
conspicuous enough to be easily read
by the user of the pesticide product.
Directions for use may appear on
printed or graphic matter which ac-
companies the pesticide provided that:
(A) If required by the Agency, such
printed or graphic matter Is securely
attached to each package of the pesti-
cide, or placed within the outside
wrapper or bag;
Flash point I Required text
(A) PRESSURIZED CONTAINERS
Flash point at or below 20 F; if there is a flashback at
any valve opening.
pj i point above 20 F and not over 80’ F or it the
me extension is more than 18 In long at a distance
of Sin from the flame.
sJ other pressurized containers
Extremely flammable. Contents under pressure. Keep away from
fire, sparks, and heated surfaces. Do not puncture or Incinerate
container. Exposure to temperatures above 1 30 F may cause
bursting.
Flammable. Contents under pressure. Keep away from heat,
sparks, and open flame. Do not puncture or incinerate container.
Exposure to temperatures above 130 F may cause bursting.
Contents under pressure. Do not use or star, near heat or open
flame. Do not puncture or IncInerate container. Exposure to
temperature, above 130’ F may cause bursting.
(B) NONPRESSURIZED CONTAINERS
At or below 20 F
Above 20 F and nOt aver 60’ F
Above 80 F and not over 150’ F
Extremely flammable. Keep away from fire, sparks, and heated
surfaces.
Flammable. Keep sway from heat and open flame.
Do not use or store near heat or open flame.
81
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§ 156.10
40 CFR Ch. I (7-1-89 Edition)
(B) The label bears a reference to
the directions for use in accompanying
leaflets or circulars, such as “See di-
rections in the enclosed circular:” and
(C) The Administrator determines
that it is not necessary for such direc-
tions to appear on the label.
(ill) Exceptions to requirement for
direction for use—(A) Detailed direc-
tions for use may be omitted from la-
beling of pesticides which are intended
for use only by manufacturers of prod-
ucts other than pesticide products in
their regular manufacturing processes,
provided that:
(1) The label clearly shows that the
product is intended for use only in
manufacturing processes and specifies
the type(s) of products involved.
(2) Adequate information such as
technical data sheets or bulletins, is
available to the trade specifying the
type of product involved and Its
proper use in manufacturing process-
es;
(3) The product will not come into
the hands of the general public except
after incorporation into finished prod-
ucts; and
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(B) Detailed directions for use may
be omitted from the labeling of pesti-
cide products for which sale i limited
to physicians, veterinarians, or drug-
gists, provided that:
(1) The label clearly states that the
product Is for use only by physicians
or veterinarians;
(2) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment; and
(3) The product is also a drug and
regulated under the provisions of the
Federal Food, Drug and Cosmetic Act.
(C) Detailed directions for use may
be omitted from the labeling of pesti-
cide products which are intended for
use only by formulators in preparing
pesticides for sale to the public, pro-
vided that:
(1) There Is Information readily
available to the formulators on the
composition, toxicity, methods of use,
applicable restrictions or limitations,
and effectiveness of the product for
pesticide purposes;
(2) The label clearly states that the
product is intended for use only in
manufacturing, formulating, mixing,
or repacking for use as a pesticide and
specifies the type(s) of pesticide prod-
ucts involved;
(3) The product as finally manufac-
tured, formulated, mixed, or repack-
aged is registered; and
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(2) Contents of Directions for Use.
The directions for use shall include
the following, under the headings “Di-
rections for Use”:
(I) The statement of use classifica-
tion as prescribed In paragraph (j) of
this section immediately under the
heading “Directions for Use.”
(ii) Immediately below the state-
ment of use classification, the state-
ment “It is a violation of Federal law
to use this product in a manner incon-
sistent with its labeling.”
(iii) The site(s) of application, as for
example the crops, animals, areas, or
objects to be treated.
(iv) The target pest(s) associated
with each site.
(v) The dosage rate associated with
each site and pest.
(vi) The method of application, in-
eluding Instructions for dilutio i, if re-
quired, and type(s) of application ap-
paratus or equipment required.
(vii) The frequency and timing of.ap-
plications necessary to obtain effective
results without causing unreasonable
adverse effects on the environment.
(viii) Specific limitations on reentry
to areas where the pesticide has been
applied, meeting the requirements
concerning reentry provided by 40
CFR Part 170.
(ix) Specific directions concerning
the storage and disposal of the pesti-
cide and Its container, meeting the re-
quirements of 40 CFR Part 165. These
instructions shall be grouped and
appear under the heading “Storage
and Disposal.” This heading must be
set in type of the same minimum sizes
as required for the child hazard warn-
ing. (See Table in § 162.10(h)(1)(iv))
82
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§ 156.10
Prot.ction Ag.ricy
AnY limitations or restrictions on
requ1r 1 to prevent unreasonable
use effeCtL such as:
‘MA) gequired intervals between p.
j tion and harvest of food or feed
CrOPsRotatjonaj crop restrictions.
(C) ai n1g5 as required against use
n certain crops, animals, objects, or
or adjacent to certain areas.
(D) (Reserved]
(E) For restricted use pesticides, a
statem 1t that the pesticide may be
5 pplled under the direct supervision of
a certified applicator who is not phys-
j fly present at the site of application
but nonetheless available to the
persofl applying the pesticide, unless
the Agency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who is physically present.
(F) Other pertinent information
whiCh the Administrator determines
to be necessary for the protection of
man and the environment.
(J) Statement of Use Classification.
By October 22, 1976, all pesticide prod-
ucts must bear on their labels a state-
ment of use classification as described
in paragraphs (1) (1) and (2) of this
section. Any pesticide product for
which some uses are classified for gen-
eral use and others for restricted use
shall be separately labeled according
to the labeling standards set forth in
this subsection, and shall be marketed
as separate products with different
registration numbers, one bearing di-
rections only for general use(s) and
the other bearing directions for re-
stricted use(s) except that, if a product
has both restricted use(s) and general
use(s), both of these uses may appear
on a product labeled for restricted use.
Such products shall be subject to the
provisions of paragraph (J)(2) of this
section.
(1) General Use Classification. Pesti-
cide products bearing directions for
use(s) classified general shall be la-
beled with the exact words “General
Classification” Immediately below the
heading “Directions for Use.” And ref-
erence to the general classification
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 misbranding.
(2) RestrIcted Use Classification.
Pesticide products bearing direction
for use(s) classified restricted shall
bear statements of restricted use clas-
sification on the front panel as de-
scribed below:
(I) Front panel statement of restrict-
ed use classification. (A) At the top of
the front panel of the label, set in type
of the same minimum sizes as required
for human hazard signal words (see
table in paragraph (h)(1)(iv) of this
section), and appearing with sufficient
prominence relative to other text and
graphic material on the front panel to
make it unlikely to be overlooked
under customary conditions of pur-
chase and use, the statement “Re-
stricted Use Pesticide” shall appear.
(B) Directly below this statement on
the front panel, a summary statement
of the terms of restriction imposed as
a precondition to registration shall
appear. If use is restricted to certified
applicators, the following statement is
required: “For retail sale to and use
only by Certified Applicators or per-
sons under their direct supervision and
only for those uses covered by the Cer-
tified Applicator’s certification.” If,
however, other regulatory restrictions
are Imposed, the Administrator will
define the appropriate wording for the
terms of restriction by regulation.
(40 FR 28268, July 3, 1975. 40 FR, 32329,
Aug. 1, 1975; 40 FR 38571, Aug. 21, 1975, as
amended at 43 FR 5788, Feb. 9, 1978. Redes-
ignated and amended at 53 FR 15991, 15999,
May 4, 1988]
83
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