United States Environmental Office of Prevention, Pesticides EPA 735-B-03-001
Protection Agency & Toxic Substances (7506C) August 2003
&EPA Label Review Manual
3rd Edition
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TABLE OF CONTENTS
LABEL REVIEW MANUAL, 3rd EDITION
Date Issued
Chapter 1 Purpose of Manual August 2003
Purpose
Content
Approach
Use of "Must" and "Should" in This Manual
Availability
Internally
Externally
Maintenance/Update
Chapter 2 What Is a Pesticide? August 2003
Introduction
Products That Have Been Determined Not to be Pesticides
What Makes a Product a Pesticide?
Pesticides Exempted from Registration
Is the Product a Device and, Therefore, Not a Pesticide?
Chapter 3 General Labeling Requirements August 2003
Introduction
General Information
Definition of "Label" and "Labeling"
Container Label Contents When Booklets are Used
Small Packaging Information on the Label
Collateral Labeling
Material Safety Data Sheets
Mandatory/Advisory Statements
Mandatory Statements
Advisory Statements
Master Label Concept
Non-FIFRA Labeling
Label Submission Requirements
Label Format
Introduction
Front Panel
Front or Back Panel
Back Panel
Final Printed Labels and Labeling
Sample Label Formats
Chapter 4
Types of Label Review
August 2003
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Introduction
Submissions That Do Not Require Label Review
Supplemental Distributors
Exemptions
Notifications/Non-Notifications
Submissions That Require Label Review
Old Chemicals and Amendments, without Data
Fast Track
Data Compensation
Me-Too's
Old Chemical and Amendments with Data
Products for Which Efficacy Data Must Be Submitted
New Chemical and New Uses
Technical Grade and Manufacturing Use Products
Special Local Needs
Experimental Use Products
Use Deletions
Resubmissions
Chapter 5 Ingredient Statement August 2003
Introduction
What is Included in an Ingredient Statement
Format
Active Ingredient
Inert Ingredient
Contents
Headings
Percentages
Expanded Inert Statements
Location of Ingredient Statement
Front Panel
Location on Front Panel
Outside Wrappers
Names to be Used in the Ingredient Statement
First Steps
Common Name
Chemical Name
CAS (Chemical Abstract Service) Number
Microbial Name
Descriptive Name
Trademark Name
Criteria for Determination of Pesticidal Activity
Is the Ingredient Considered to be Active
Related Compounds (Active)
Related Compounds (Inert)
Equivalents
Statement of Concentration
Definition
Expressions
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Sub statements (Footnotes)
Petroleum Distallates
Inerts of Toxicological Concern
Arsenic
Sodium Nitrite
Deterioration
General Labeling
Sodium Hypochlorite
Specific Designations for Some Ingredient Statements
Inert Ingredients
Special Labeling Requirements for Inerts of Toxicol ogical Concern (List 1)
Identification of Inert/Other Ingredients
Alternate Formulations
Introduction
Unclassified Products
Criteria
Restricted Use Pesticides (RUP)
Determination of Classification
Labeling Requirements for RUPs
Wording of the RUP Terms of Restriction
Proper Labeling Format for RUP Statements
Introduction
Section Contents
Purpose of Statements
Background Information
Documents Used to Determine Contents of Precautionary Statements on Labels
Acute Toxicity Data
Use of RED's
Determining the Precautionary Labeling
The Signal Word
Poison-Skull and Crossbones Symbol
Child Hazard Warning Statement
Hazards to Humans and Domestic Animals Statements
Personal Protective Equipment
First Aid Statements
Note to Physicians
Labeling Options
Use Dilutions
Other Deviations
Chapter 6 Use Classification
August 2003
Chapter 7 Precautionary Labeling
August 2003
Chapter 8 Environmental Hazards
Introduction
Reviewing the Statement
August 2003
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Does the Product Require an Environmental Hazards Statement?
Statement Location
Support for Statements
General Statements
Non-Target Organism Statements
Miscellaneous Statements
Introduction
Placement of the "Physical or Chemical Hazards" Statement
Labeling for Flammable Products
Declaration of Non-Flammability
Non-Flammability Claim
Criteria for Declaring Non-Flammability
Non-Flammability Label Statement and Placement
Labeling for Liquid Products Used Near Electrical Equipment
Labeling for Explosiveness Potential
When Required
Recommended Chemicals
Additional Label Statements for Certain Fumigants
Warning Statements about Mixing Certain Products
Requirement for Use of Fire Retardant
Other Physical/Chemical Hazard Statements
Introduction
Background
The WPS
Pesticide Reregi strati on
Evaluating the RED Document and the Worker Protection Standard
Determination of Products Subject to the Worker Protection Standard
Scope of WPS
Criteria
Signal Word
Split Labeling for WPS Products and Occupational Use Products
Precautionary Statements
Handler Personal Protective Equipment
Pesticide User Safety Requirements
Engineering Control Statements
User Safety Recommendations
Directions for Use
Products Subject to WPS
Determining the Correct REI
REI(s) for Fumigants
REI(s) Determined by Subdivision Data (158.390)
All Other REI(s)
Labeling Statements for Special Situations
Chemigation Statement
Soil Incorporation/Injection/Seed Treatment
Chapter 9 Physical or Chemical Hazards
August 2003
Chapter 10 Worker Protection Labeling
August 2003
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Engineering Control Statements
ULV and LV Uses
Sample Agricultural Use Requirements Box
Chapter 11 Directions for Use August 2003
Introduction
Purpose
Format
Clarity
Example
Application Rate
Review Strategy for Directions for Use
Type of Label Reviews for Directions for Use
Analysis of Directions for Use
Key Questions to be Answered When Reviewing the Directions for Use Section
Content
Manufacturing Use Products
Pesticide Products Intended for Use Only by Physicians, Veterinarians, or Pharmacists
Typical End-Use Pesticide Products
Standard Requirements
Directions for Use Heading
Misuse Statement
Worker Protection Standard
Application Information
Content
Chemigation Information
Spray Drift Labeling
Guidance for Wording Application Information
The Intended User
The Pests Being Claimed
Where the Product is Used
Use-Related Information
How the Product is Prepared and Handled
Use Restrictions
Additional Application Information
Pre Harvest Interval
Net Contents and Application Rate
Other Information Pertaining to Specific Applications
Storage and Disposal
Appendix A - Label Reviewer's Checklist
Chapter 12 Labeling Claims August 2003
Introduction
General Claims
Some Examples of Unacceptable Claims
Product Names
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Efficacy Related Claims
Instructions to Label Reviewers
Warranty and Disclaimer Statements
Claims Made in Advertising
Chapter 13 Storage and Disposal
Introduction
Statement Location
Format
Type Size Requirement
Determining Storage and Disposal Labeling
Pesticide Storage Statements
Pesticide Disposal Statements
Container Disposal Statements
Chapter 14 Identification Numbers
Introduction
EPA Registration Number
Purpose and Form of the Registration Number
Assignment of Registration Number
Location of the Registration Number
Supplemental Distributor Numbers
EPA Establishment Number
Purpose and Location of Establishment Number
State Designations
Multiple Establishment Numbers
Special Local Need (SLN) Registration Number
Experimental Use Permit Number
Chapter 15 Company Name and Address
Introduction
Phone Numbers
Foreign Registrants
Name of Record
Company Name and Address Changes
Chapter 16 Graphics & Symbols on Labels
Introduction
Acceptable Graphics & Symbols
Unacceptable Graphics & Symbols
Other Graphics & Symbols Which are Acceptable
Chapter 17 Contents/Net Weight Statement
Introduction
Location of Net Contents/Net Weight Statement
Types of Products/Measurement
Expression of the Statement
August 2003
August 2003
August 2003
August 2003
August 2003
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Units of Measure
Expression of Net Contents
Consistency with Directions for Use
Chapter 18 Unique Product Labeling August 2003
Introduction
Multi-Packs/Co-packs
A Pesticide Packaged with a Non-Pesticide
Two or More Pesticides Packaged Together
Small Containers
Soluble Packets
Bulk Containers
Foreign Language Labeling
Pesticides Used to Treat Seeds
For Commercial Seed Treatment Products
For Hopper-Box Use Products
Child-Attracting Packaging ("Attractive Nuisance")
Secondary Containers
Child Resistant Packaging
Attached Label Booklets
Chapter 19 The Consumer Labeling Initiative and Pesticide Labels August 2003
Background
What is the CLI?
CLI, Phases I and II
Quantitative Research
Qualitative Research
Research Findings
Major Recommendations from CLI
Label Changes
Educational Changes
Workgroup Issues
Format Suggestions Based on CLI Research
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NOTE TO READER:
The Agency is interested in optimizing the usefulness of the LRM as a tool for understanding
the pesticide labeling process. If you notice errors in or ways to improve the LRM, please contact
the Office of Pesticide Programs at 703 308-9068. The Agency considers this document to be an
instructional aid that does not establish new guidance, but instead compiles extant interpretations
of statutory and regulatory provisions and reiterates extant Agency policies. This tool is also useful
in understanding approaches for how labels should generally be drafted. As always, the Agency will
consider each label on its own merits and will consider deviations from Agency policy in labeling
under the appropriate provisions of FIFRA and its implementing regulations.
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Chapter 1 PURPOSE OF MANUAL
I. PURPOSE
A. This Label Review Manual (LRM) serves as a training tool for Office of Pesticide
Program's (OPP) employees and as guidance for product management team members who are
responsible for performing label reviews. The goal of the LRM is to improve the quality and
consistency of labels. In addition, this manual may be useful for state label reviewers, registrants
and other individuals interested in producing readable, unambiguous pesticide labels.
B. It is important to note that the Federal Insecticide, Fungicide and Rodenticide Act
("FIFRA") and it's implementing regulations include specific requirements for label language and
format and, therefore, govern what must (and what cannot) appear on the label. Documents such
as this and Pesticide Registration Notices ("PRN's") provide guidance on how the Agency interprets
the applicable law.
C. In addition to considering the guidance provided in this manual, it is the responsibility of
the label reviewer or writer to consider all chemical and product specific information affecting
labeling such as science reviews, Federal Register Notices and Reregi strati on Eligibility Decision
documents ("REDs").
D. The approach and information set forth in this document is intended solely as guidance.
This manual does not impose binding obligations on either existing registrants, applicants for
registration or EPA.
II. CONTENT
A. The second chapter of this manual provides a definition of a "pesticide" and describes
pesticide labels and labeling. The third chapter discusses general label format and legibility
requirements, identifies the major parts of the label, and directs the user to the appropriate chapters
in this manual where additional information can be found. The remainder of the manual provides
step-by-step instructions concerning the review of a pesticide label and any associated actions and
situations that may arise during label review. Information in the manual is roughly arranged in the
order of use by reviewers. Chapter 18 provides information about how unique labeling issues have
been handled in the past, so that reviewers can apply this information to future similar situations.
Purpose of Manual
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III. APPROACH
A. The chapters of this manual have been numbered independently to aid future updating.
Individual chapters can be updated as new policy is instituted which changes the guidance contained
in a particular chapter. Each chapter will display its current issuance date.
B. This manual provides a systematic approach to the label review process. Most label reviews
involve products that make reference to another label and which are not accompanied by data.
When reviewers compare new, proposed labels to previously registered labels, the existing,
registered label may have errors or be out-of-date. If the existing label has deficiencies, the
proposed label may bear the same errors. Consequently, label reviewers must not rely solely on a
label-to-label comparison, but must review a label based on applicable law and guidance.
IV. AVAILABILITY
A. INTERNALLY. All chapters in this manual are included in th q Labeling Policy Directory,
which is located under Vol # 1 on DCCMAPPSO1 under M:\APPS\OPP\SHARED\RD\LABELING,
under the subdirectory label.man on OPP's Local Area Network (LAN). The Labeling Policy
Directory contains all policy documents (such as letters, memos, relevant PR Notices, etc.) related
to labeling. In the manual, chapters are organized following the sections of a pesticide label. The
reader should refer to the INDEX under the directory for the chapter names.
B. EXTERNALLY. The LRM is available from the National Technical Information Service
(NTIS) in Springfield, Virginia. To order documents from NTIS, call 1-800-553-6847. The LRM
is also located on the Internet at: www.epa.gov/oppfeadl/labeling/lrm. For additional
information, contact the Labeling Team at 703-308-9068.
V. MAINTENANCE/UPDATE
A. For accurate maintenance of this manual, it is imperative that OPP staff bring to the
attention of the Labeling Team any document which affects generic labeling policy. Discrepancies
or problems should be brought to the attention of the Labeling Team by calling 703-308-9068.
Purpose of Manual
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Chapter 2 WHAT IS A PESTICIDE?
I. INTRODUCTION
A. This chapter discusses the statutory and regulatory criteria used to determine whether or not
a product is a pesticide requiring registration under FIFRA. Relevant FIFRA definitions are found
in section 2 of the statute and the applicable regulations are at 40 CFR Part 152, Subparts A and B.
Label reviewers should use the statute and regulations when evaluating the "pesticide" status of
products or potential products. It is acceptable to discuss whether hypothetical products are
pesticides with anyone, including state enforcement personnel, registrants, applicants or the general
public. Whether or not a particular product that is the subject of an application is a pesticide under
FIFRA must be treated confidentially through applicable CBI protections. A final decision about
the pesticide status of a particular product must be made in writing to the applicant or registrant and
should be in response to a written request for an Agency determination which includes proposed
labeling and the composition of the product.
B. As discussed in detail below, there are a number of types of products that the Agency has
determined are not pesticides and others that the Agency has exempted from regulation even though
they are pesticides. If a label reviewer determines that a product is a pesticide, the label reviewer
should consider whether the pesticide has been exempted from the FIFRA registration requirements.
C. If the label reviewer determines that the product is not a pesticide, the label reviewer must
consider whether the product is a device. The last section of this chapter addresses this topic.
II. PRODUCTS THAT ARE NOT PESTICIDES
A. Some substances and products may be excluded from FIFRA registration if they meet certain
conditions or criteria. 40 CFR 152.6 sets out the following types of products which can fall into
this category.
1. Liquid chemical sterilants. A liquid chemical sterilant product is not a pesticide under
section 2(u) of FIFRA if it meets all of the following criteria. Excluded products are regulated by
the Food and Drug Administration (FDA). Products excluded are those meeting all of the following
criteria:
a. Composition. The product must be in liquid form as sold or distributed. Pressurized
gases or products in dry or semi-solid form are not excluded by this provision. Ethylene oxide
products are not liquid products and are not excluded by this provision.
b. Claims. The product must bear a sterilant claim, or a sterilant plus subordinate
level disinfection claim. Products that bear antimicrobial claims solely at a level less than "sterilant"
are not excluded and are jointly regulated by EPA and FDA.
c. Use site.
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(1) The product must be intended and labeled only for use on "critical or
semi-critical devices." A "critical device" is any device which is introduced directly into the human
body, either into or in contact with the bloodstream or normally sterile areas of the body. A
semi-critical device is any device which contacts intact mucous membranes but which does not
ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body.
(2) Liquid chemical sterilants that bear claims solely for use on non-critical
medical devices are jointly regulated by EPA and FDA.
(3) Liquid chemical sterilants that bear claims solely for use on sites that are not
medical devices, such as veterinary equipment, are not excluded and are regulated solely by EPA.
2. Nitrogen stabilizers. A nitrogen stabilizer is excluded from regulation under FIFRA
if it is a substance (or mixture of substances), meeting all of the following criteria:
a. The substance prevents or hinders the process of nitrification, denitrification,
ammonia volatilization, or urease production through action affecting soil bacteria and is distributed
and sold solely for those purposes and no other pesticidal purposes. For purposes of 40 CFR 152.6,
living organisms are not considered to be substances, and the actions of living organisms are not
relevant to whether a substance is deemed to be a nitrogen stabilizer.
b. The substance was in "commercial agronomic use" in the United States before
January 1, 1992. EPA considers a substance to be in commercial agronomic use if it is available for
sale or distribution to users for direct agronomic benefit, as opposed to limited research,
experimental or demonstration use.
c. The substance was not registered under FIFRA before January 1, 1992.
d. Since January 1, 1992, the distributor or seller has made no claim that the product
prevents or hinders the process of nitrification, denitrification, ammonia volatilization or urease
production. See 40 CFR 152.6 to learn what EPA considers to be a claim that the product prevents
or hinders nitrification, denitrification, ammonia volatilization or urease production and for further
information on this topic.
3. Products intended for use only for the control of fungi, bacteria, viruses, or other
microorganisms in or on living man or animals, and labeled accordingly. Such products
include, for example: Athlete's foot remedies, dandruff medications, aquaculture and aquarium
additives for treatment of fish diseases, and dermal disinfectants. Note: These exceptions apply only
to antimicrobials (fungicides, disinfectants, viricides, etc.). Insecticides (pesticides that kill insects
as opposed to microbes) are not included in the "living body" exception. Thus, products such as
mosquito repellents, flea and tick remedies for pets, and other insecticides and acaricides (except
head and body lice products) used directly on the living body of humans, pets, and livestock have
historically been considered to be pesticides and are required to be registered. Note that contact lens
solutions that disinfect the lens in the contact lens holder are exempt from federal registration under
FIFRA through an agreement with the Food and Drug Administration. An animal feed containing
an animal drug is not a pesticide under section 2(u) of FIFRA. An animal feed containing an animal
drug is subject to regulation by the FDA under the FFDCA.
What is a Pesticide?
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4. Products intended for use only for control of internal invertebrate parasites or
nematodes in living man or animals, and labeled accordingly.
5. Products intended only to aid in the growth of desirable plants such as those
products that fall within one of the categories (a-g) below.
As an initial matter, it is important to note that there is an important distinction between
plant nutrients, which may be exempt from registration, and plant regulators, which require
registration (and are defined in FIFRA at 2(v)). Plant nutrients are described below. Whether a
product is considered to be a plant growth regulator basically turns on whether the plant response
or mode of action being claimed would go beyond what would be expected from simple nutrition.
Claims such as increased blossom set, stimulation of root growth, prevention of sucker growth,
delayed onset of sprouting of harvested root crops and abscission stimulation for fruit crops can be
considered to be plant growth regulator claims. In this area, the composition of the product may aid
in making the determination. Compounds such as auxins, cytokinins, and gibberellins have no other
uses except as plant growth regulators. Therefore, the presence of any of those compounds generally
causes a product to be considered to be a plant growth regulator. However, products containing
auxins, cytokinins, and gibberellins may be exempt from registration if the labeling meets the
criteria for vitamin-hormone horticultural products under 40 CFR 152.6(f)
Products that aid in the growth of desirable plants can include:
a. Plant or leaf coatings designed to protect against frost or to retard water loss
through transpiration. These types of products are usually glycerol-based. Similar products are
sometimes sold as cut-flower preservatives. As long as plant disease or plant regulator claims are
not made for the product and its composition is not such that pesticide benefits would be delivered,
registration has historically not been required.
b. Products sold as vase water additives for cut flowers, although such products bear
special scrutiny. If they are composed, as many are, of simple sugars intended to supply
nourishment to the cut flower, they are likely not under the purview of FIFRA. Historically,
however, products with claims to prevent bacterial or fungal growth in the vase water, claims such
as "delays flower opening", claims to control stem rot or decay or products with chemicals that only
have pesticidal uses have been subject to FIFRA registration.
c. Food washing products that do not claim to remove bacteria such as e-coli or
salmonella.
d. Fertilizer products not containing a pesticide, such as sphagnum moss used as
plant growth media to retard damping-off.
e. Plant inoculant products consisting of microorganisms applied to the plant or soil
for the purpose of enhancing the availability or uptake of plant nutrients through the root system.
f. Soil amendment (e.g., vermiculite, sand, lime) products containing a substance or
substances added to the soil for the purpose of improving soil characteristics favorable for plant
What is a Pesticide?
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growth. See 152.6(g)(3) [previously 40 CFR 152.8(c)(4)], Soil amendments are intended to
increase porosity, retain moisture, adjust pH, and other uses intended to benefit crop production.
For example, although normally considered to be a fungicide or miticide, products containing sulfur
when applied to soil to solely adjust the pH have historically not been subj ect to registration. Sulfur
may also have nonpesticidal uses as a foliar plant nutrient at low concentrations.
g. Plant nutrient products consisting of one or more macronutrients or micronutrient
trace elements necessary to normal growth of plants and in a form readily useable by plants.
6. Antimicrobial products used solely in processed foods or feeds, in beverages, or
in pharmaceuticals. Cracking, milling, grinding and other processes that cause a physical change
in the commodity are methods that meet the definition of "processed." Substances used in these
processes against microbes in or on the processed food are not pesticides under FIFRA and are
regulated by FDA, not EPA. Drying, husking and shelling do not meet the definition of "processed"
so that products used during these processes are FIFRA pesticides and are regulated by EPA under
FIFRA. Cosmetics are pharmaceuticals regulated by FDA. See 40 CFR 152.5(d).
B. Products that are not intended to prevent, destroy, repel, or mitigate a pest, or to defoliate,
desiccate, or regulate the growth of plants are not considered to be pesticides. Some of these
products may appear to be pesticides, but are not considered as such unless pesticidal claims are
made on their labeling or in connection with their sale and distribution. 40 CFR 152.10 lists
products which fall under this category.
1. Deodorizers, bleaches, and cleaning agents. OPP has treated products bearing claims
for sanitizing or disinfecting properties as pesticides requiring registration. For example, a bleach
which consists of 5.25% sodium hypochlorite would likely require registration if the label states that
bacteria will be killed at certain doses. An identical bleach would not likely need to be registered
if the labeling only claims to whiten, bleach or clean laundry, and does not contain an explicit or
implicit antimicrobial claim.
2. Products not containing toxicants intended only to attract pests for survey or
detection purposes, and labeled accordingly.
3. Products that are intended to exclude pests only by providing a physical barrier
against pest access, and which contain no toxicants. Examples might include: pruning for trees;
latex or asphalt tree wound dressings that make claims of preventing the entrance of insects or fungi
into fresh cut surfaces of plants; cocoa bark or pine bark mulches that claim suppression of weed
growth; black plastic or tar-paper used to suppress weeds or prevent the entrance of insects.
III. WHAT MAKES A PRODUCT A PESTICIDE?
A. The term "pesticide" is defined at FIFRA 2(u). One of the most important words in the
FIFRA definition of "pesticide" is "intended." One of the analytical steps to determining whether
a product is a pesticide is to consider whether the product is "intended" to be used as a pesticide.
Products are generally considered to be pesticides if they are intended for preventing, destroying,
repelling, or mitigating any pest or intended for use as a plant regulator, defoliant, or desiccant. OPP
What is a Pesticide?
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determines intent by examining claims on the label, advertising; composition/use; and/or mode of
action of the product as distributed or sold. Section 40 CFR 152.15 sets forth the criteria to help
establish intent. If the regulatory criteria are met the label reviewer can conclude that the product
is a pesticide and must be registered. The regulatory criteria are described below:
1. Claims. If a person who distributes or sells the product claims, states or implies by
labeling or otherwise (such as, advertising, collateral literature, or verbal statements), that the
product can or should be used as a pesticide or that the product contains an active ingredient and that
it can be used to manufacture a pesticide, then the product is a pesticide. See 40 CFR 152.15(a)(1)
and (a)(2).
2. Composition. If a product is composed of one or more active ingredients that have no
other significant commercially valuable use other than for a pesticidal purpose or for use in
manufacturing a pesticide then the product historically has been considered to be a pesticide. For
example, a company markets a granular product that has labeling identifying the presence of 2,4-D,
directions to apply it to lawns at a certain dosage rate, and warns the user about over-application,
but does not claim that broad-leaved weeds will be killed, is the product a pesticide? Most likely,
the product is a pesticide because 2,4-D is a well known herbicide and has no other significant
commercially valuable use.
3. Knowledge that the substances will be used as a pesticide. Even if pesticidal claims
are not made for the product, if the person who distributes or sells the substance has actual or
constructive knowledge that the substances will be used, or is intended to be used, for a pesticidal
purpose, the product is a pesticide product required to be registered.
IV. PESTICIDES EXEMPTED FROM REGISTRATION
A. The Agency has exempted certain pesticides from regulation under FIFRA under the
authority of FIFRA 25(b) because the pesticides have been determined to be (1) adequately
regulated by another Federal agency or (2) of a character which is unnecessary to be subject to
FIFRA. Just because a pesticide is exempted under FIFRA, however, does not mean that the Federal
Food, Drug and Cosmetic Act (FFDCA) or state laws may not apply. For example, even if a
pesticide product meets the conditions for exemption from regulation under FIFRA, it might still be
subject to FFDCA requirements requiring a tolerance or tolerance exemption if there is a pesticide
chemical residue on food. The following are examples of products exempted from FIFRA under
25(b):
1. Pesticides Regulated by Another Federal Agency
a. Certain Biological Control Agents. Biological control agents are generally exempt
from FIFRA regulation. However, the Agency has determined (40 CFR 152.20(a)(3)) that the
following biological control agents are not exempt and are subject to FIFRA.
(1) Eucaryotic microorganisms, including protozoa, algae, and fungi;
(2) Procaryotic microorganisms, including bacteria; and
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(3) Viruses.
b. Certain Human Drugs. A product that is intended solely for human use and also
is a new drug within the meaning of FFDCA 201(p) or is an article that has been determined by the
Secretary of Health and Human Services not to be a new drug by a regulation establishing conditions
of use for the article, is exempt from the requirements of FIFRA. See 40 CFR 152.20(b) for more
details.
2. Pesticide Not of a Character Requiring FIFRA Regulation
a. Treated Articles or Substances. This covers article or substance treated with, or
containing, a pesticide to protect the article or substance itself, if the pesticide is registered for such
use. Generally speaking, claims about such products should be limited to the protection of the
article itself and the pesticides used for those purposes must be registered and bear appropriate
directions for such uses. See 40 CFR 152.25(a) and PR Notice 2000-1. Examples include:
(1) Paints that have been treated with an antimicrobial pesticide and bear claims
that the dried paint film will be resistant to mildew. Historically, OPP has not accepted, expressed
or implied claims made for protection of the surface beneath the paint film or for prevention of mold
spores that could infect foods or beverages. Paints that are to be used in canneries, breweries,
hospitals, or other areas where a crucial consideration is prevention of bacteria or mold that would
pose a health risk are generally not subject to the treated articles exemption and, therefore, generally
not exempt from FIFRA regulation.
(2) Shower curtains treated with a fungicide to retard mildew growth; lumber
treated with a wood preservative; bathroom caulks impregnated with a mildewcide; and fabrics and
leather treated with preservative compounds are other examples of products that OPP has historically
viewed as treated articles.
b. Pheromones and Pheromone Traps. Pheromones and identical or substantially
similar compounds labeled for use only in pheromone traps (or labeled for use in a manner which
the Administrator determines poses no greater risk of adverse effects on the environment than use
in pheromone traps), and pheromone traps in which those compounds are the sole active ingredient
are not subject to FIFRA regulation. Refer to 40 CFR 152.25(b)(1), (b)(2), and (b)(3) to determine
whether a substance is a pheromone for purposes of this exemption. Refer to 40 CFR 152.25(b)(4)
to determine whether the pheromone trap falls within the exemption. Pheromones are chemicals
used in intra-species communication. A chemical used in inter-species communication (i.e., using
fox urine to repel rabbits) is an "allomone" and would be subject to FIFRA.
c. Preservatives for Biological Specimens
(1) Embalming Fluids. Mortuary supplies intended to prevent or mitigate mold
and bacteria on or in human cadavers are exempt because: The rationale for this exemption is that
the use is limited to embalmers and morticians who are specially trained to handle such products and
do not require the protection afforded by registration. The general public would not be exposed to
such products. See 40 CFR 152.25(c)(1).
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(2) Animal and animal organ preservatives. This includes products used to
preserve animal or animal organ specimens in mortuaries, laboratories, hospitals, museums, and
institutions of learning. See 40 CFR 152.25(c)(2).
(3) Preservatives for Laboratory Analysis. Products used to preserve the
integrity of milk, urine, blood, or other bodily fluids for laboratory analysis. See 40 CFR 152.25(3).
d. Vitamin Hormone Products. See 40 CFR 152.6(f) (previously 40 CFR 152.25(d).
e. Foods. Products consisting of foods and containing no active ingredients, which
are used to attract pests. See 40 CFR. 152.25(d)).
f. Natural cedar. Natural cedar blocks, chips, shavings, balls, chests, drawer liners,
paneling, and needles that meet all of the following criteria:
(1) The product consists totally of cedarwood or natural cedar;
(2) The product is not treated, combined or impregnated with any additional
substance(s); and
(3) The product bears claims or directions for use solely to repel arthropods
other than ticks or to retard mildew, and no additional claims are made in sale or distribution. The
labeling must be limited to specific arthropods, or must exclude ticks if any general term such as
"arthropods," "insects," "bugs," or any other broad inclusive term, is used. The exemption does not
apply to natural cedar products claimed to repel ticks. The exemption does not apply to cedar oil,
or formulated products which contain cedar oil, other cedar extracts, or ground cedar wood as part
of a mixture. See 40 CFR 152.25(e).
g. Minimum Risk Pesticides. 40 CFR Section 152.25(f) (previously 40
CFR152.25(g)) exempts certain "minimum risk pesticides" from the requirements of FIFRA
(including registration) if they satisfy all the conditions described in that provision (i.e.,
152.25(f)(l )-(3)). Products not meeting all the conditions in the regulation may still be exempt from
regulation. Some of the conditions of exemption specifically relate to a product's labeling (see
152.25(f)(3)). For further information, see PRN 2000-6: "Minimum Risk Pesticides Exempted
under FIFRA Section 25(b) Clarification of Issues." See also the notice published in the Federal
Register, September 28, 1994 (59 Fed. Reg. 49400) for the list of minimum risk inerts (also known
as the List 4A inerts).
V. IS mi PRODUCT A DEVICE AND, THEREFORE, NOT A PESTICIDE?
FIFRA defines a device as "any instrument or contrivance (other than a firearm) which is
intended for trapping, destroying, repelling, or mitigating any pest or any other form of plant or
animal life (other than man and other than bacteria, virus, or other microorganism on or in living
man or other living animals); but not including equipment used for the application of pesticides
when sold separately therefrom." See FIFRA 2(h). FIFRA does not require the registration of
pesticidal devices. Devices, however, are subject to a number of FIFRA's provisions including,
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labeling requirements and establishment numbers identifying the location where the device was
produced. See 40 CFR 152.500 for more information on devices and additional FIFRA
requirements.
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Chapter 3 GENERAL LABELING REQUIREMENTS
I. INTRODUCTION
This chapter addresses "labels and labeling," labeling submission requirements, the sample
label format, and guidance concerning specific label requirements versus preferred label
language. The sample label format which appears at the end of this chapter is designed to
illustrate the typical arrangement of information on a pesticide label.
II. GENERAL INFORMATION
A. DEFINITION OF "LABEL" AND LABELING
1. FIFRA section 2(p) defines the terms as follows:
a. Label. The term "label" is defined as "the written, printed, or graphic matter on,
or attached to, the pesticide or device or any of its containers or wrappers."
b. Labeling. The term "labeling" is defined as "all labels and all other written,
printed, or graphic matter
(1) accompanying the pesticide or device at any time; or
(2) to which reference is made on the label or in literature accompanying the
pesticide or device, except to current official publications of the Environmental Protection
Agency, the United States Departments of Agriculture and Interior, and the Department of Health
and Human Services; State experiment stations, State agricultural colleges; and other similar
Federal or State institutions or agencies authorized by law to conduct research in the field of
pesticides."
B. CONTAINER LABEL CONTENTS WHEN BOOKLETS ARE USED
Registrants are allowed to provide part of the label text in the form of a booklet or other "pull
off type labeling, when it is not feasible or possible to literally "fit" the entire label on the
container. [40 CFR 156.10.] Pursuant to the regulations set out at 40 CFR part 156, Subpart A,
the following label information, however, must be on the label which is on or "securely attached"
to the container. "Securely attached" means the label can reasonably be expected to remain affixed
during the foreseeable conditions and period of use. [40 CFR 156.10(a)(4).]
- Name and address of the producer, registrant, or person for whom produced
- Restricted Use Statement (if required)
- Product Name, Brand or Trademark
- Ingredient Statement
- Signal Word, including Skull & Crossbones, if either are required
- "Keep Out Of Reach Of Children" (KOOROC)
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- Precautionary Statements, including Hazards to Humans & Domestic Animals
- EPA Registration Number and EPA Establishment Number
- Storage and Disposal Statements
- Referral Statement to Directions for Use in booklet, if any (supplemental labeling)
- Net weight or measure of contents
Other parts of the label may be placed in a booklet or other "pull off type labeling.
1. The Agency's regulation requires that words, statements, graphic representations,
designs or other information that are legally required to appear on a label be clearly legible,and
readily understood by the ordinary individual. In addition, all required label text must appear on
a clear contrasting background and not be obscured or crowded. 40 CFR 156.10(a)(l)(2)
C. COLLATERAL LABELING. Bulletins, leaflets, circulars, brochures, data sheets, flyers
or other written, printed or graphic matter which are referred to on the label or which are to
accompany the product are known in Agency practice as "collateral labeling". Such labeling is
subject to applicable requirements of FIFRA and the Agency's regulations, and for example, may
not bear claims or representations that substantially differ from those accepted in connection with
registration of the product. [FIFRA 12(a)(1)(B).] Collateral labeling must be submitted along with
the application for registration and must be accepted by EPA before it can be distributed.
D. MATERIAL SAFETY DATA SHEETS (MSDSs). The Occupational Safety and Health
Administration (OSHA), and not the Agency has direct authority over MSDSs. However, when
an MSDS is distributed with a pesticide it becomes a part of the pesticide labeling [FIFRA 2
(p)(2)(A).] Because an MSDS becomes part of the labeling, an MSDS could render the pesticide
misbranded if the MSDS includes warnings, precautions or any other information that conflict
with the FIFRA-approved label. [FIFRA 2(q)] The registrant must ensure that the MSDS which
accompanies the product is not inconsistent with the approved labeling. In the event of
inconsistency the registrant may need to either seek approval of labeling changes from EPA or
change the MSDS (See PR Notice 92-4).
Although an MSDS which accompanies a pesticide product is considered to be labeling,
EPA required statements cannot be placed directly on the MSDS instead of the label. For the
purpose of labeling the Agency does not review or accept (stamp) MSDSs. The Agency may
refer to a product's MSDSs to extract certain information such as the product's physical/chemical
properties or composition.
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III. MANDATORY AND ADVISORY STATEMENTS
A. MANDATORY STATEMENTS. Mandatory statements generally relate to the actions that
are necessary to ensure the proper use of the pesticide and to prevent the occurrence of unreasonable
adverse effects on the environment, which is defined by statute. Mandatory statements include
directions for use and precautions that direct the user to take or avoid specific actions. The
directions and precautions specify where, when and how a pesticide is to be applied. Mandatory
statements are generally written in imperative or directive sentences (e.g., "Wash application
equipment...," "Do not use ...," "Users must...," "Apply to corn at a maximum rate of one to two
pounds per acre 30 days prior to harvest"). Either EPA or the registrant may develop mandatory
labeling statements. When writing mandatory statements, both EPA and the registrant need to
ensure that such statements meet the criterion above that the statement is necessary to ensure proper
use of a pesticide and to prevent unreasonable adverse effects on the environment. The following
directions and precautions are examples of mandatory statements:
"Wear chemical resistant gloves."
"If swallowed, call a doctor."
"Do not induce vomiting."
"Do not apply within 66 feet of wells."
"Do not apply directly to water."
"Keep away from heat, sparks and open flame."
"Do not enter into treated areas for 12 hours."
"Apply immediately after mixing."
"Do not apply when wind speed exceeds 15 mph"
B. ADVISORY STATEMENTS. Advisory statements provide information to the product user
on such topics as product characteristics and how to maximize safety and efficacy while using the
product. Such statements are acceptable as long as they do not conflict with mandatory statements,
and are not false or misleading, or otherwise violate statutory or regulatory provisions.
1. Advisory statements are best written in descriptive or nondirective terms. Phrasing
advisory statements in straightforward, factual terms minimizes the possibility thatthey will conflict
with mandatory statements. The use of certain words such as "should," "may" or "recommend" in
advisory statements has the potential to lead the product user to erroneously believe that he/she must
comply with such statements, when in fact such statements do not have to be followed. These words
may also give the user the erroneous impression that a use that is not recommended is still somehow
permitted (that is, someone could believe that a particular use is permitted because a statement
recommending against such use does not have to be followed). To avoid these potential problems,
the best way to express advisory statements is to use descriptive or nondirective language.
Nevertheless, EPA will allow the use of "should," "may," "recommend" or similar terms on a case-
by-case basis as long as they do not appear to cause these kinds of problems.
2. Following are hypothetical advisory statements followed by examples of how they can
be rewritten using descriptive terms, which is EPA's preference. These examples are arranged as
follows:
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a. A typical label advisory statement as it may have been written prior to PR
Notice 2000-5, Guidance for Mandatory and Advisory Labeling Statements.
b. The same advisory statement written using the preferred descriptive terms.
3. Precautionary Statements
a. Latex gloves are recommended.
b. Latex gloves provide the best protection.
4. Physical and Chemical Hazards
a. It is preferable to open containers of aluminum phosphide products in open air
as under certain conditions they may flash upon opening. Containers may also
be opened near a fan or other appropriate ventilation which will rapidly exhaust
contaminated air.
b. Opening aluminum phosphide containers outdoors or indoors near an exhaust
fan or other ventilation ensures that the gas will be rapidly dispersed if the
product flashes.
5. Directions for Use
Mixing
a. Tank mixtures should be applied immediately after preparation. If for any
reason this is not possible, ensure that sufficient agitation has been provided to
re-mix all products and check for complete resuspension prior to application.
b. Applying the product immediately after preparation ensures that it is in
suspension. If application is delayed, agitation to re-mix the products and
checking for resuspension ensures proper blending.
Application
al. Factors such as depth to the drain system, soil type, and degree of compaction
should be taken into account in determining the depth of treatment.
b 1. The depth of treatment depends on the depth of the drain system, soil type, and
degree of soil compaction.
a2. It may be necessary to treat along one side of interior partition walls if there are
cracks in the slab, plumbing entry points, existing termite infestations, or other
conditions which would make treatment appropriate.
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b2. Treatment along one side of interior partition walls where there are cracks in the
slab, plumbing entry points, existing termite infestations, or evidence of other
means of access prevents further infestation.
a3. Rotary hoeing is recommended for preemergence applications which do not
receive adequate rainfall or sprinkler irrigation to wet the top 2 inches of soil or
to the depth of germinating weeds within about 10 days after application.
b3. If rainfall or sprinkler irrigation does not wet the top 2 inches of soil or depth
of germinating weeds within 10 days of a preemergence application, rotary
hoeing will ensure soil incorporation.
a4. The spray mixture should be directed to the soil around the base of the cotton
plants. Care should be taken to prevent the spray from striking the cotton leaves
as injury will occur. The use of leaf lifters or shields on application equipment
is recommended to avoid spraying the cotton foliage.
b4. Directing the spray mixture around the base of the cotton plants and using leaf
lifters and shields on application equipment will help minimize foliage contact
and plant injury.
Cleaning
a. It is recommended that the sprayer be thoroughly cleaned by flushing with a
detergent solution at the end of each work day when any emulsifiable oil, oil
concentrate, or other emulsifiable formulation has been used either alone or in
tank mix combinations with other pesticide formulations, even if no obvious
problems have been encountered. This precaution will ensure a clean sprayer
and continued trouble-free operation.
b. If an emulsifiable oil, oil concentrate, or other emulsifiable formulation has
been used, flushing the sprayer with a detergent solution at the end of the
workday will ensure a clean sprayer and trouble-free operation.
IV. MASTER LABEL-SUB-LABEL-SPLIT LABEL-SUPPLEMENTAL DISTRIBUTOR
LABEL AND SUPPLEMENTAL LABELING CONCEPTS
A. Types of labels and labeling include a Master Label, Split-Label or Sub-Label,
Supplemental Distributor Label and Supplemental Labeling.
1. Master Label. A "Master Label" is a label that contains all of the approved uses
for a given product and all associated required labeling.
2. Sub-Label. A "Sub-Label" or "Split-Label" is a label which bears claims and
directions for only a portion of the approved uses under a given product but is a complete
label itself, containing all of the required labeling elements. Agency regulations allow a
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registrant to distribute or sell a product under a "Sub-Label" or "Split-Label" provided that
in limiting the uses identified on the label, no changes would be necessary to the
precautionary statements, use classification, or packaging of the product. See 40 CFR.
152.130(b). Since there are no changes being made which would require submission of an
amendment to the labeling, split-labels and sub-labels are not required to be submitted to the
Agency for approval. If these labels are intended to be distributed under a different product
name, the Agency must approve the alternate brand name. [40 CFR 156.10(b)(2)(ii).]
3. Supplemental Distributor. Supplemental distributor labels are labels for a
product which is registered to one company but distributed by another company. These labels
may be the master label or a split/sub-label and may only differ from the approved label by
having a different brand name, company name and distributor number. See 40 CFR152.132.
The agency must be notified before distribution by submission of a notice of Supplemental
Distribution (see chapter 4). Supplemental distributor labels are not submitted to the Agency.
4. Supplemental labeling. "Supplemental labeling" is a term used by the Agency to
describe labeling which includes uses, use directions, or other instructions which differ from
those on the master label. These are partial labels to be distributed with the product and may
be distributed by the registrant or the supplemental distributor. Since these are partial labels,
they must bear a statement referring the user to the product label for complete directions and
a statement that the labeling must be in the possession of the user. Both the product label and
the supplemental labeling are required to safely and effectively apply the product.
Supplemental labeling is used for state registration of special local needs under section 24c
of FIFRA but may also be appropriate for other situations. For labeling requirements for
supplemental labeling for State registrations, refer to 40 CFR 162.153(e)(3). Supplemental
labeling submitted by the registrant must comply with the same requirements except the
specific information relating to the State registration is omitted. Supplemental labeling must
be submitted to and be approved by the Agency. At the minimum the Agency always
recommend that these labels bear the following information:
- Misuse statement
- The labeling must be in possession of the user at the time of application.
- Read the label affixed to the container for Pesticide X before applying.
- Use of pesticide X according to this labeling is subject to the use precautions
and limitations imposed by the label affixed to the container for pesticide X.
- Product Name
- EPA Registration Number
- Restricted Use Statement (if required)
B. Labeling use patterns are captured by the Pesticide Product Information System
(PPIS) for registration purposes and the Label Use Information System (LUIS) for
reregistration purposes. It is very important that the Agency be able to easily and accurately
identify the registered use for any product. LUIS and PPIS capture use sites, application
methods (type, timing, and equipment), application rates, frequency of application, maximum
number of applications, treatment intervals, and any use limitations (e.g., preharvest intervals,
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reentry intervals) from approved Section 3 and Section 24(c) labels. The aggregated use
pattern defined by LUIS is the basis for risk assessment in reregistration, while PPIS provides
the basis for determining what uses are currently registered. The registrant must submit and
maintain a "Master Label" bearing all registered uses for each registered product. The
regulations allow the reviewer to request the complete text of the proposed amended label at
any time.
C. Over time, registrants may choose to change product labels. These changes are
accomplished through the submission of amended labels, by notification, or by "non-
notification". [40 CFR 152.44; 152.46(a)&(b).] Agency regulations at 40 CFR 152.50(E)
allow applicants to submit partial labels reflecting only the proposed amendments or the
changes by notification. Partial label submissions speed up the review process because the
reviewer does not have to review the entire label, and they cut down on paper work because
the entire label does not have to be submitted with every amendment.
1. This process, however, makes it more difficult to determine the scope of
registration for a given product. Therefore, applicants should clearly indicate when their
partial labels do not contain the entire use profile for the product and any specific label
sections which are being changed should be clearly marked. In order to effectively monitor the
scope of the registration, Registrants will be asked to indicate at the top of the label whether
it is a "Split Label" or "Sub Label or "Master Label." Registrants should also include a
reference to the "Master Label" and its last accepted date. For example:
SPLIT/SUB LABEL (Supplemental) - Revises Master Label dated XXXXX
2. After several of these 'Split-Labels" or "Sub-Labels" or "Supplemental Labels"
have been submitted, the registrant will be asked to submit a new "Master Label" containing
all the uses currently approved under the product's registration. The reviewer decides how
often a "Master Label" should be requested. When the updated "Master Label" is submitted,
the registrant should request that it be stamped "accepted" to assure that the Agency's and
registrant's records are complete and accurate. Note that there are limitations on how long
a registrant can sell a product under old labeling. [40 CFR 152.130(c).]
V. NON-FIFRA LABELING
Some labels submitted to the Agency have information devoted to non- FIFRA issues, e.g.,
Department of Transportation (DOT) shipping rules, New York City fire code symbols, Hazardous
Materials Identification System (HMIS) and National Paints and Coatings Association (NPCA)
and National F ire Protection Association (NFP A) hazard codes and rating systems, F ood and Drug
Administration or State Department of Agriculture numbers, and bar codes. A registrant may
choose to place such text on the label but may not replace, obscure, conflict with, or supersede the
FIFRA required text.
VI. LABEL SUBMISSION REQUIREMENTS
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A. Reviewers should only accept draft labeling for review that meets the regulatory
requirements including those set out in [40 CFR 152.50.] Agency preference has been to ask
registrants to follow some of the other steps outlined below, that are not required by law.
1. Submissions for new registrations or amendments must include five copies of all draft
labeling (typescript or mock-up). [40 CFR 152.50.] For all amendments, the Agency prefers that
one copy of the draft proposed label be marked up or annotated in some way, such as
Redline/Strikeout, to indicate what has been changed. The other four copies should be "clean"
or not annotated in any way, but include all label changes for which the amendment is submitted.
2. All copies must be legible and should be of suitable quality for making legible
photocopies. [40 CFR 152.50.] OPP's practice has been to request that draft labeling have print
size of at least 12 characters per inch to aid in label review and to ensure that additional
photocopies will be legible.
3. Registrants are asked to submit draft labeling on 8V2"xl 1" paper.
B. If the draft labeling submitted by the applicant does not meet the above criteria, the
reviewer shall send a letter to the applicant describing the submission deficiencies and request the
applicant revise its draft labeling.
VII. LABEL FORMAT
A. INTRODUCTION. Listed below are the various sections of the label in the approximate
order they should appear on a label. Several sample label formats appear at the end of this chapter.
Each section below corresponds to the chapter in this manual which discusses that particular part
of the label in more detail. Note that somewhat different formats are used for certain classes of
products (e.g., rodenticide baits).
B. FRONT PANEL
1. Restricted Use Pesticide Statement (Chapter 6) if applicable
This section of the label, if applicable, includes the references to "restricted use", which
under FIFRA Section 3 (d)(1)(c) describes those pesticides that require "additional
regulatory restrictions" to avoid potential unreasonable adverse effects on the
environment.
2. Product Name, Brand or Trademark (Chapter 12)
3. Ingredient Statement (Chapter 5)
This section of the label identifies the name and the percentage by weight of each active
ingredient and the percentage by weight of other/inert ingredients. If the size or form of
the product package makes it impracticable to place the ingredient statement on the front
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panel of the label, permission may be granted for the ingredient statement to appear
elsewhere. See 40 CFR. 156.10(g)(2).
4. "Keep Out of Reach of Children" (KOOROC) Statement (Chapter 7)
This specific statement, which is commonly referred to as the KOOROC statement
("child hazard warning"), appears on almost all end use pesticide products except those
pesticides that are intended for use on children or where it is demonstrated that children
will not come in contact with the product. In these cases, a modified statement is
allowed.
5. Signal Word (Chapter 7)
Signal words which correspond to the toxicity categories for product hazards (e.g., oral,
dermal) appear on the front panel of the label.
6. First Aid (Statement of Practical Treatment) (Chapter 7)
A first aid statement must appear on the front panel of all Toxicity Category I
pesticides, but the agency may allow reasonable variations in the placement of the
statement. [40 CFR 156.10(h)(l)(iii).] The front panel must include a reference such as
"See statement of practical treatment on back panel" near the word "poison" and the
skull and crossbones if the Agency allows the first aid information to appear on the back
panel. [40 CFR 156.10 (h)(l)(iii).]
7. "Skull & Crossbones" Symbol and the word "POISON" (Chapter 7)
These symbols identify pesticide products which are determined to be in Toxicity
Category I based on at least one of the following acute toxicity studies: acute oral, acute
dermal or acute inhalation or contains certain inert ingredients. [40 CFR
156.(h)(l)(i)(A); FIFRA 2(q)(2)(d).]
8. Net Contents/Net Weight (Chapter 17)
This section identifies the weight or volume of pesticide in the container.
C. FRONT OR BACK PANEL
1. EPA Registration Number & Establishment Number (Chapter 14)
The EPA Registration Number is the single most important piece of information for
tracking pesticide products. The EPA Registration Number must appear on the label
of the product. 40 CFR156.10(e). The EPA Establishment Number identifies the final
physical location where the pesticide product was produced or labeled. The EPA
Establishment Number may appear on any suitable location on the label or immediate
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container, however, it must appear on the wrapper or outside container of the package
if the number cannot be clearly read through the wrapper or container. See 40 CFR
156.10(f).
2. Company Name & Address (Chapter 15)
This section of the label identifies the name and address of the producer, registrant or
person for whom the product is produced.
D. BACK PANEL
1. Precautionary Statements
a. Hazards to Humans and Domestic Animals (Chapter 7)
Where a hazard exists to humans or domestic animals precautionary statements that
describe the particular hazard, route of exposure and precautions to be taken must
appear on the label. See 40 CFR 156.10(h)(2)(i).
b. First Aid (Statement of Practical Treatment) (Chapter 7)
This section of the label provides information to the pesticide user concerning
appropriate first aid for the various routes of exposure associated with accidental
exposure. [40 CFR 153.10(h)(l)(iii).]
c. Environmental Hazards (Chapter 8)
Where a hazard exists to non-target organisms precautionary statements that
identify the hazards and necessary precautions must appear on the label. See 40
CFR 156.10(h)(2)(h).
d. Physical or Chemical Hazards (Chapter 9)
Hazards such as flammability, explosive potential or dielectric breakdown and the
various precautions to be taken must be identified, as applicable. [40 CFR
156.10(h)(2)(iii).]
2. Directions for Use (Chapter 11)
This section of the label provides instructions to the user on how to use the product, and
identifies the pest(s) to be controlled, the application sites, application rates and any
required application equipment. This section may also include certain worker protection
issues such as a reentry statement which identifies the specific time period following
treatment during which entry into a treated area is restricted. As further described in
Chapter 11, other issues must be addressed in the directions for use. [40 CFR 156.10(i).]
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3. Storage and Disposal (Chapter 13)
This section of the label provides instructions for storing the pesticide product and for
disposing of any unused pesticide and the pesticide container. [40 CFR
156.10(i)(2)(ix).]
4. Warranty Statement (Chapter 12)
This is a disclaimer statement included voluntarily on most pesticide products by the
registrant.
5. Worker Protection Labeling (Chapter 10)
All WPS labeling requirements have been consolidated into this chapter. [40 CFR 156
Subpart K.]
VIII. FINAL PRINTED LABELS AND LABELING
A. Final printed labels or labeling must be filed and accepted by the Agency prior to product
registration, although applicants need not submit final versions until draft labeling has been
provisionally accepted by the Agency. In some cases, reproductions of unusual labels (e.g.,
silkscreen) are acceptable. See 40 CFR 156.10(a)(6). Agency practice is to request two copies
of the final printed labeling that will accompany the pesticide product when distributed or sold.
The type size of final printed labels may be checked by using the template on the following page.
Make a copy of the template on a transparency sheet (be sure to copy it using a 1:1 ratio or 100%
setting on most photocopies-no enlargement or reductions). Overlay the template printed on a
transparency on the final printed label and compare the type size of the Signal Word, and the
"Keep Out of Reach of Children" statement on the printed label with that of the template. The
table at the top of the chart may be used to determine the appropriate type size based on the size
of the label.
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Label Type Point Chart
Si/e (»T l.ahel on l-'ronl
Panel in Square Inches
SIGNAL WORDS as Required
Mini in ii in Type Si/e | All Capilals|
"Keep Out <>l' Reach of
Children" as Required
5 and under
6 point
6 point
above 5 up to 10
10 point
6 point
above 10 up to 15
12 point
8 point
above 15 up to 30
14 point
10 point
over 30
18 point
12 point
NOTE: No type on any label can be less than 6 point.
is point POISON DANGER WARNING CAUTION
12 point KEEP OUT OF REACH OF CHILDREN
12 point Keep Out of Reach of Children
14point POISON DANGER WARNING CAUTION
10 point KEEP OUT OF REACH OF CHILDREN
10 point Keep Out of Reach of Children
12 point POISON DANGER WARNING CAUTION
8 point KEEP OUT OF REACH OF CHILDREN
8 point Keep Out of Reach of Children
10 point POISON DANGER WARNING CAUTION
6 point KEEP OUT OF REACH OF CHILDREN
6 point Keep Out of Reach of Children
6 pOint POISON DANGER WARNING CAUTION
6 pOint KEEP OUT OF REACH OF CHILDREN
6 point Keep Out of Reach of Children
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PRODUCT NAME
[product information: (like what this product is used for)]
CAUTION
KEEP OUT OF REACH OF CHILDREN
If Swallowed
If Inhaled
If on Skin
If in Eyes
Note to Physician:
[Product NameJ is an organopiiosphate pesticide that inhibits choiinesterase.
SEE OTHER PANEL FOR PRECAUTIONARY STATEMENTS
ACTIVE INGREDIENT(S): 90.00%
OTHER INGREDIENTS:3 iaoo%
TOTAL: 100.00%
This product contains __ lbs of^AiJ per gallon.
EPA Registration No.
EPA Establishment No.
[Registrant Name]
[Address]
[Telephone Number]
Net Contents
PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS AND
DOMESTIC ANIMALS
CAUTION
PPE
ENVIRONMENTAL HAZARDS
PHYSICAL OR CHEMICAL HAZARDS
DIRECTIONS FOR USE
It is a violation of Federal law to use this product in a
manner inconsistent with it labeling.
GENERAL INSTRUCTIONS AND
INFORMATION
GENERAL INFORMATION (non-site-specific):
GENERAL PRECAUTIONS AND RESTRICTIONS
(non-site-specific):
TT". Sitp-
TT". Sitp-
TT". Sitp-
TT". Sitp-
TT°"
TT". Sitp-
TT°"
TT". Sitp-
RTORflnF
ni.QPn.Qfli
APPLICATION INSTRUCTIONS
(site-specific)
STORAGE AND DISPOSAL
WARRANTY STATEMENT
1. When First Aid statements appear on the front panel they should be grouped together with the other precautionary statements, preferably appearing first, immediately following the general heading "Precautionary Statements".
2. Content of the Note to Physician is determined, in part, by the Acute Toxicity Review.
3. A complete listing of inert ingredients may be provided below the ingredient statement.
-------
Non-Restricted Use Sample Label
PRODUCT NAME
Product information: (what is product used for)
KEEP OUT OF REACH OF CHILDREN
SIGNAL WORD
If Swallowed
If Inhaled
If on Skin
If in Eyes
Reminder to have label. Emergency phone number.
2
Note to Physician:
SEE OTHER PANEL FOR PRECAUTIONARY STATEMENTS
90.00%
10.00%
ACTIVE INGREDIENT(S):
OTHER INGREDIENTS: 3
TOTAL: 100.00%
This product contains lbs of ra.i.l per gallon.
EPA Registration No.
EPA Establishment No.
[Registrant Name]
[Address]
[Telephone Number]
Net Contents
PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS AND
DOMESTIC ANIMALS
CAUTION
PPE
ENVIRONMENTAL HAZARDS
PHYSICAL OR CHEMICAL HAZARDS
DIRECTIONS FOR USE
It is a violation of Federal law to use this product in a
manner inconsistent with its labeling.
GENERAL INSTRUCTIONS AND
INFORMATION
4
Chemigation Instructions or Prohibition (If required):
SPRAY DRIFT LABELING (If applicable) :
DIRECTIONS for USE
(continued)
Mnm-rrnp/Sitp/Ppct-
xwi_rv^p/s;wp»>ct.
xwi_rv^p/s;wp»>ct.
xwi_rv^p/s;wp»>ct.
xwi_rr^p/s;t»>/p<»ct.
Mnn-rrnp/Sitp/Ppct-
xwi.rv^p/sjWPect-
Mnn-rrnp/Sitp/Ppct-
xwi_rr^p/s;t»>/p<»ct.
STORAGE AND DISPOSAL
PF.qTir.inF CTOBtrj
PF.qTir.inF ni.qpn.qAI
CONTAINER DISPOSAL
WARRANTY STATEMENT
1. When First Aid statements appear on the front panel they should be grouped together with the other precautionary statements, preferably appearing first, immediately following the general heading "Precautionary Statements".
2. Content of the Note to Physicians is determined in part by the Acute Toxicity Review.
3. A complete listing of inert ingredients may be provided below the ingredient statement.
4. Required except for products intended solely for residential use; direct injection into plants; post harvest application, or application only as a gas or solid (e.g., pellet, tablet, granule, or dust formulations).
-------
Restricted Use Pesticide - Worker Protection Standarc
Sample Label
RESTRICTED USE PESTICIDE
(If applicable)1
Due to (insert reason)
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.
PRODUCT NAME
product information: (what is product used for)
KEEP OUT OF REACH OF CHILDREN
SIGNAL WORD
(ENGLISH\SPANISH)
Poison
[Skull & Crossbones]
Si usted no entiende la etiqueta, busque a alguien para que se la explique a
usted en detalle. (If you do not understand the label, find someone to explain
If Swallowed
[ f Inhaled
If on Skin
If m Eyes
Note to Physician:
First Aid
ACTIVE INGREDIENT(S): 90.00%
OTHER INGREDIENTS:4 10.00%
TOTAL:
100.00%
This product contains lbs of fa.i.1 per gallon.
SEE OTHER PANEL FOR PRECAUTIONARY STATEMENTS
EPA Registration No.
EPA Establishment No.
[Registrant Name]
[Address]
[Telephone Number]
Net Contents
PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS AND
DOMESTIC ANIMALS
DANGER
PPE ~
User Safety Requirements
Engineering Controls:
ENVIRONMENTAL HAZARDS
PHYSICAL OR CHEMICAL HAZARDS
DIRECTIONS FOR USE
RESTRICTED USE PESTICIDE
(if applicable)
It is a violation of Federal law to use this product in a
manner inconsistent with its labeling.
Do not apply this product in a way that will contact
workers or other persons, either directly or through
drift. Only protected handlers may be in the area
during application.
For any requirements specific to your State or Tribe,
consult the agency responsible for pesticide regulation.
AGRICULTURAL USE
REQUIREMENTS
Use this product only in accordance with its labeling
and with the Worker Protection Standard, 40 CFR 170.
This Standard contains requirements for the
NON-AGRICULTURAL USE
REQUIREMENTS
(If applicable)
Chemigation Instructions or Prohibition (If required):
SPRAY DRIFT LABELING (If applicable) :
DIRECTIONS for USE
(continued)
rmp/Ritp/Ppgt-
rrnp/Ritn/Pnct-
rrnp/Ritn/Pnct-
rrnp/Rito/Poct-
STORAGE AND DISPOSAL
PFQTTr-TnF CTnparj
PFQTTr-TnF nTapnaBT
CONTAINER
DISPOSAL
WARRANTY STATEMENT
1. Restricted Use classification as specified in 40 CFR 152.160 - 175.
2. When First Aid statements appear on the front panel they should be grouped together with the other precautionary statements, preferably appearing first, immediately following the general heading "Precautionary Statements"
3. If required content of the Note to Physician is determined, in part, by the Acute Toxicity Review.
4. A complete listing of inert ingredients may be provided below the ingredient statement.
5. Required except for products intended solely for residential use; direct injection into plants; post harvest application, or application only as a gas or solid (e.g. pellet, tablet, granule, or dust formulations).
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Label Review Manual
Current as of August 2003
Chapter 4 TYPES OF LABEL REVIEWS
I. INTRODUCTION
A. Label reviews are conducted for many types of submissions. How a reviewer proceeds with
a label review depends on the type of action proposed by the registrant and whether the submission
is a new submission (first time submitted to the Agency) or a resubmission (follow-up to a previous
submission).
B. When a registrant submits information pertaining to several products that are similar in
composition or a series of dilutions (products that have the same active ingredient (a.i.) and other
ingredients so when diluted they may be considered identical), every effort should be made to route
and review these submissions together to ensure consistency of labeling decisions.
II. SUBMISSIONS THAT DO NOT REQUIRE LABEL REVIEW
A. SUPPLEMENTAL DISTRIBUTOR. After a registrant has obtained registration for
its pesticide product, a second person or company may then distribute or sell the basic registrant's
product under the second person or company's name and address. Such distribution and sale is
termed "supplemental distribution" and the product is referred to as a "distributor product."
Supplemental distribution requires an agreement between the basic registrant and the second
company (usually referred to as the "distributor"). Both companies confirm the distributor
arrangement by submitting a completed Notice of Supplemental Distribution of a Registered
Pesticide Product form (EPA Form 8570-5) for each distributor product. (See 40 CFR 152.132 for
other requirements). The distributor is considered an agent of the registrant for all purposes under
FIFRA and both the distributor and the registrant can be held liable for violations pertaining to the
distributor product. [40 CFR 152.132.] The basic registrant is requested to notify EPA if it
terminates its agreement with a supplemental distributor. Supplemental distributor labels are not
submitted to EPA for review. If submitted they will not be stamped "Accepted," or even retained
in Agency files (See Chapter 14 for more information on distributor labeling).
B. EXEMPTIONS. FIFRA section 25(b) authorizes the Agency to exempt from FIFRA
regulation any pesticide which the Agency determines either (1) to be adequately regulated by
another Federal agency or (2) to be a character which is unnecessary to be subject to FIFRA In
either case, the pesticide labels do not need to be submitted to the Agency. 40 CFR 152.25(g) and
PR Notice 2000-6 (for minimum risk pesticides) describe the conditions of exemption and the
requirements to meet the exemption. No false or misleading labeling statements under 40 CFR
156.10(a)(5)(i) through (viii) may appear on an exempt pesticide product. Only minimum risk inerts
from the current updated List 4A may be used to formulate exempt pesticides. List 4A can be found
at http://www.epa.gov/opprd001/inerts/inerts_list4.pdf.
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C. NOTIFICATION/NON-NOTIFICATION. The Agency' s regulations (40 CFR152.46,
and PR Notice 98-10) allow registrants, without Agency approval, to make certain modifications
to their label that have no potential to cause unreasonable adverse effects to the environment. Some
of these changes can be made simply by "Notification"; which involves an Application for
Registration form (EPA Form 8570-1) marked "Notification," a copy of the labeling with changes
highlighted, and a Certified Statement of the Notification, submitted to the Document Processing
Desk. Notifications are processed separately than amendments and generally within 30 days. If
the
"notification" documents raise a concern with the label reviewer, he or she may require the registrant
to submit a application for amendment when necessary. [40 CFR 152.46.] The following
modifications are some that can be made by notification. Refer to PR Notice 98-10 for specific
information on the circumstances under which notification is appropriate and for additional topics
that can be modified through notification.
Adding or changing alternate brand names
Changing primary product name
Adding or deleting pests (exceptions include, but are not limited to, pests of public health
significance, termites or pests under USD A quarantine)
Adding indoor, nonfood sites to antimicrobial products
Changes in packaging and related labeling statements
Use deletions related to Data Call-Ins
Storage and disposal statements
Use of symbols and graphics (except Skull & Crossbones)
Changes in Warranty Statements
There are changes to labels can be made without notification to the Agency. PR Notice 98-10
identifies those label topics that can be amended through "non-notification." Please note that other
PRNotices may permit certain label modifications by notification for specific Agency initiated label
changes. Please also be aware that the Antimicrobial's Division notification process is different
from other Divisions. See PR Notice 98-10 for details.
III. SUBMISSIONS THAT REQUIRE LABEL REVIEW
A. The following types of submissions require label review:
Old Chemicals and Amendments, without Data
Fast track
Data compensation
Me-Too's
Old Chemical and Amendments, with Data
Products for which Efficacy Data must be Submitted
New Chemical and New Uses
Technical Grade and Manufacturing Use Products
Special Local Needs
Experimental Use Permits
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B. OLD CHEMICALS AND AMENDMENTS, WITHOUT DATA. This type of submission
involves an application for an "old" chemical (i.e., active ingredient) currently registered for use
as a pesticide. Thus, nothing "new" is proposed for the chemical or formulation. These
submissions may also include applications for amendments to labels of existing product
registrations. An example is an amendment for the addition to the label of a new site or pest which
has been previously approved by the Agency for other products containing the same active
ingredient. For products composed of multiple active ingredients, the proposed "new site or pest"
must be previously approved for all of the a.i.'s.
C. FAST TRACK. An application is considered a fast track action for review if no data or
only product chemistry data are submitted. If a registrant chooses to submit acute toxicity data and
efficacy data to fulfill the data requirement, the action will not be considered as a fast track action.
When label amendments subject to data compensation requirements and procedures are requested
(such as when adding a crop), the whole product (not just the added crop) is subject to the data
compensation requirements and procedures.
D. DATA COMPENSATION. If no new formula is being proposed, no additional acute
toxicity data submissions are required, although data citations may be required (see 40 CFR 152.80
through 152.97). If a crop is added to a label as a me-too submission, data must still be cited
because residue data were originally required to register the use on the crop unless the formulator's
exemption can be used. Citation of data protects the rights of data submitter(s) by the new
registrant's acknowledging the studies and offering to pay the submitter(s) compensation for the cost
of generating the original data.
E. ME-TOO'S. For me-too submissions, the pesticide product and the proposed use must
be identical or substantially similar to a currently registered pesticide. [FIFRA 3(c)(7)(A).] The
applicant must cite the currently registered pesticide product by EPA registration number. The
reviewer must ensure that the two products are substantially similar or identical in formulation. To
make this determination, refer to the guidance below:
1. If the a.i. in the product is subject to a completed Reregi strati on Eligibility
Decision (RED) Document. If it is, the me-too submission must comply with the terms of that RED
document.
2. Acute toxicology data from one product will support another product if:
a. According to the Confidential Statement of Formula (CSF) the proposed
product is identical to the cited product.
b. The proposed product is "substantially similar" to the cited product, for
example the only difference is that a minor intentionally added component (<1%) is replaced by 2
components with the same function, adding up to the same percentage as the one replaced.
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Label Review Manual
Current as of August 2003
c. The proposed product is essentially a dilution of the cited product with water
and the cited product is in Category III or IV for all acute toxicity endpoints.
d. The proposed product is essentially an aqueous dilution of the cited product,
is a Category I or II endpoint for one or more acute toxicity endpoints, and a precautionary review
shows that the two products are substantially similar.
e. The proposed product has the same active ingredient in the same percentage
as the cited product, different intentionally added inert ingredients perform the same functions in
approximately the same percentages, and a precautionary review shows that the proposed and
current products are substantially similar.
3. The pH's of the two products may provide an indication of whether the products
are similar. Sometimes they are widely different. Differences in the pH's can affect irritancy and
even oral toxicity. If the products look alike, but have widely different pH's, the application must
provide a rationale that would justify treatment of the second product as a "me too". If the pH's
are not close to identical, this is a signal that the products are not similar.
4. The label reviewer must also ensure that the new use patterns, including any new
or additional public health pests, are the same. In addition, if the label under review is a rodenticide,
repellent, or antimicrobial bearing a public health claim, any changes in the other intentionally added
ingredients must be cleared by the efficacy reviewers to make certain that these changes will not
affect the efficacy of the product (i.e., change of bait color, smell, texture, etc.) No changes to the
composition of the rodenticide baits or repellents may be accepted without an efficacy review.
5. The registrant must submit complete product chemistry data for Manufacturing
Use Products (MPs) and End-Use Products (EPs) that are produced by integrated systems. The label
reviewer should send product chemistry data for product chemistry review. The product chemistry
reviewer will compare the concentrations of the active ingredients and their associated impurities
to determine substantial similarity in accordance with Standard Operating Procedure 3068.2.
6. For all EPs that are formulated with a registered source product and are found to
be toxicologically similar, product chemistry data are required in accordance with 40CFR 158.150-
190, and should be reviewed by Product Chemistry for adequacy, completeness and validity of the
data.
7. If the proposed me-too product is found to be dissimilar to the cited product, then
the label review process is suspended. The reviewer should prepare correspondence to the registrant
noting that the Agency has determined that the cited, registered product is not substantially similar
to the proposed product and the registrant must submit the required studies or cite another product
that is substantially similar.
8. If the me-too product is a "repack" (i.e., the product is simply repackaging from
another registered product, with no changes to its composition), check the proposed product's
Confidential Statement of Formula (CSF) with the CSF of the cited product to make certain the
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Label Review Manual
Current as of August 2003
formulations are the same. If so, no data are required. Note the CSF should state "Repack of EPA
Reg. No."
F. OLD CHEMICALS AND AMENDMENTS WITH DATA. This type of submission
involves an old chemical currently registered active ingredient) or a "me-too" where "something
new" is being proposed. For example, the proposal may involve a new use, a new application rate,
or a change in precautionary statements. Basically, it is an action not previously approved by the
Agency, and a review more extensive than a simple me-too comparison is necessary. Supporting
data or data citations must accompany the submission. Review of the label will be based upon the
conclusions of the data reviews from the product chemists, toxicologists, or efficacy reviewers.
Generally, the specific reviews will only affect a small portion of the label; the rest of the text should
remain unchanged from the originally accepted label.
G. PRODUCTS FOR WHICH EFFICACY DATA MUST BE SUBMITTED.
1. Efficacy studies document how well pesticide formulations perform as pest control
agents. These studies may include tests to determine the lethality of a formulation against a certain
pest species, to document effectiveness under actual use situations, and/or to determine whether
claims beyond mere control are supported (i.e., length of a residual effect).
2. Although the Agency generally waives the submission of efficacy data for many
products (except for the types of products listed below), the applicant or registrant is required to
have such data on file for each product. EPA reserves the right to call in such data at any time,
either during initial review or subsequent to registration. The team reviewer should be alert to label
claims that seem to promise control or performance beyond that of similar products. Examples of
products with such claims include herbicides that claim control of weeds in lawns for one full year,
and cotton insecticides that claims total season-long elimination of pink bollworm with just one
application. When a reviewer identifies questionable or unusual efficacy claims, thePM/team leader
should be consulted and, if warranted, the applicant should be told to delete the claims or to submit
efficacy data which support the claims. If the reviewer is not sure whether proposed claims are
appropriate, the submission should be routed to an efficacy reviewer for assessment.
3. Some Types of Products Requiring Submission of Efficacy Data
a. Antimicrobials. All products (excluding those which are recommended for use
in or on living humans or animals) intended to control microorganisms infectious to humans.
b. Invertebrate Control. Products intended for use in or on humans (or in or on pets
for control of pests which attack humans such as fleas, ticks, mosquitoes, and biting flies) and in
premises or in the environment to control pests of sanitary or public health significance such as those
above as well as termites, wasps, scorpions, poisonous spiders, fire ants, cockroaches, centipedes,
and bedbugs. See PR Notice 96-7 for important information on termiticide labeling and efficacy
data requirements for termiticides.
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c. Rodenticides and Repellents. Rat and mouse control products; products used to
disperse or control birds that pose health threats; products used to control rabies vectors such as bats,
skunks, raccoons, foxes, coyotes; products used to control rodents considered to be disease vectors;
and products used to control vertebrate animals such as poisonous snakes, dogs, and bears that can
injure humans by direct attacks.
d. New Actives Ingredients or New Uses. Formulated products which either contain
new active ingredients or have proposed use patterns which differ from any previously accepted for
a similar formulation, and which have public health uses.
e. Products to Control Mycotoxin-Producing Organisms. Products intended to
control organisms that produce mycotoxins (organic compounds produced by the fungi which may
be highly toxic and carcinogenic to mammals). No such products are currently registered.
4. Product Team Structures/Roles Regarding Efficacy Data
a. Within the Office of Pesticide Programs, product performance (efficacy) data are
specific to and evaluated by the three product Divisions: Antimicrobial Division (AD), Registration
Division (RD), and Biopesticides and Pollution Prevention Division (BPPD).
b. For the Antimicrobial Division guidance documents have been developed called
DIS/TSS enclosures for the review of antimicrobial pesticides, including determination of health-
related and non-health-related issues and label requirements. Efficacy issues including label review
are handled by the Efficacy and Science Support Branch in the Antimicrobial Division. The
microbiologists within this branch are responsible for determining whether the product claims are
supported by the data and that the directions for use are appropriate for the claims.
c. Within the Fungicide and Herbicide Branches in RD, submission of efficacy data
are generally not required since the target pests seldom affect human health. Because efficacy data
is necessary for registration of certain insecticides and rodenticides, technical reviewers within the
Insecticide-Rodenticide Branch review the product performance data submitted with these products.
d. The Biopesticides and Pollution Prevention Division (BPPD), is multi disciplinary,
combining both science and regulatory personnel. BPPD has two branches: one handles
Biochemical Pesticides and the other handles Microbial and Plant Pesticides. Within each branch
there are Regulatory Action Leaders (RALs) and Science Reviewers (SRs). General label review
is the responsibility of the RAL, although SRs review certain sections (precautionary labeling,
declaration of active ingredients, storage and disposal, etc.) and provide comments to the RAL.
Since BPPD is multi-disciplinary, many RALs are scientists who also performs science reviews, and
many SRs have regulatory experience that enables them to perform regulatory actions.
H. NEW CHEMICAL AND NEW USES. This type of submission involves a new chemical
(a.i.) which is currently not registered by the Agency as a pesticide or a new use. The registrant
must propose the labeling for such products. The labeling should, however, follow the general label
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Label Review Manual
Current as of August 2003
format discussed in Chapter 3. The proposed label text may be modified as a result of the science
review.
I. TECHNICAL GRADE AND MANUFACTURING USE PRODUCTS. This type of
submission involves a product which is used to manufacture or formulate other pesticides.
Normally, a technical grade product is registered concurrently with other manufacturing use
products or end use products that can be formulated from it. (See description of these types of
products below).
1. A MP contains only the a.i. and with intentionally added inert ingredients. See 40 CFR
158.154(k) for more information. MPs are not end use products. (SEE 40 CFR 158.154(h)) An
MP contains the technical active ingredient and may contain intentionally added inerts. A technical
grade product is considered an MP, but not all MPs are technical grade products. (See 40 CFR
158.154 (h) and (k)).
2. MP registrants are required to identify in their labeling those uses which they are
supporting for registration or reregi strati on. For example, "For formulating only into end-use
products for (list the use patterns and sites)." PR Notice 94-1 recommends specific language. OPP
requires that registrants identify at a minimum, the relevant sites which are listed in Appendix A,
part 158 of the CFR (Use Pattern Index). Some MPs list very specific use patterns including pests
and in some cases site limitations to assist their formulators in preparing their application for
registration.
3. The labeling of the technical grade or manufacturing use product must fit the basic label
format, and will also include a statement such as "For Manufacturing Or Formulating Use Only"
and a listing of the use patterns and sites for the EPs to be formulated from the MP. At the
registrant's discretion, one of the two statements listed below may be added to an MP label under
"Directions for Use" to permit the reformulation of the product for a specific use or all additional
uses supported by a formulator or a user group. Each time a new use is added to the EP label, the
technical grade or MP label should be amended to add that same new use.
a. "This product may be used to formulate products for specific use(s) not listed on
the MP label if the formulator, user group, or grower has complied with the U.S. EPA data
submission requirements regarding the support of such use(s)." (See PRN 94-1).
b. "This product may be used to formulate products for any additional uses not listed
on the MP label if the formulator, user group, or grower has complied with U.S. EPA data
submission requirements regarding the support of such uses."
J. SPECIAL LOCAL NEEDS (SLN) - FIFRA Section 24(c). States have authority under
FIFRA Section 24(c) to register additional uses for a federally registered pesticide. The Agency
has ninety days to respond to the state as to whether the Special Local Need registration is
acceptable. See disapproval process at 490 CFR 162.154(c). Such registrations are for distribution
and use only within a particular state to meet a "Special Local Need" ("SLN"). Although SLNs can
be approved for many different reasons and application sites, most involve use on crops. A certain
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Label Review Manual
Current as of August 2003
crop grown within a state may be attacked by a new pest not on a current label, or state officials may
expect it to be attacked sometime during the growing season, thereby creating a special pest
problem. The pesticide (a.i.) must have an established tolerance associated with the crop, or be
exempted from the requirement of a tolerance for that crop. Although most 24(c) registrations
consist of adding a use to a federally registered product, the state may also register a new end-use
product (not federally registered) as a 24(c) registration with a stand-alone label. See 40 CFR
162.152(b)(2) for information on the types of new end-use products for which a state may issue a
24(c) registration.
1. Special Local Need labels are not stamped "Accepted," but are reviewed for the
required, pertinent information. EPA sends the State a letter acknowledging receipt of the
application. If there is a problem with the SLN (e.g., no established tolerance), a notice of intent
to disapprove is sent to the State by the PM/team leader. If something is omitted from the label, the
State is informed; however, the SLN is not disapproved. Occasionally, it is necessary to send the
SLN to the Health Effects Division (HED) for review (e.g., if there is a question on the associated
tolerance). In such cases, HED will review the label and make recommendations.
2. The Section 24(c) review process is described in further detail in OPP's Standard
Operating Procedure #4007.1, February 9, 1996.
K. EXPERIMENTAL USE PERMITS. Experimental Use Permits (EUP) authorize extensive
field trials (greater than ten acres terrestrial; one acre aquatic) of unregistered or registered pesticides
unregistered use. The EUP label follows the standard label format, except that the label must
include the EPA Experimental Use Permit No. and the statements: "Not for sale to any person other
than a participant or cooperator of the EPA approved Experimental Use program", and "For
Experimental Use Only." (Refer to 40 CFR 172.6 for additional requirements.) EUP's are usually
issued for a period of one year for a specific number of pounds to be used on a specific acreage, but
may be extended for longer periods. (See 40 CFR 172.5).
IV. USE DELETIONS
When a use is deleted from the label, the label is not stamped accepted even if it is found to be
acceptable upon reviewing. Registrant that intend to delete uses must submit an application
(amendment) form and five copies of revised labeling. See 40 CFR 152.44 and 152.50. Two copies
of a marked-up version of the previously approved labeling highlighting the deletions should be
included. Use deletions are published in the Federal register according to the requirements of
FIFRA 6(f). Any label mistakes not caught in the first review should be addressed during the second
and subsequent reviews.
V. RESUBMISSIONS
Resubmissions are follow-up applications from registrants responding to obj ections the Agency
had to their original submissions. The entire label of the subj ect product should be re-reviewed with
particular care to ensure that the registrant has answered all of the concerns identified during the
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Label Review Manual Current as of August 2003
original review. Any label mistakes not caught in the first review should be addressed during the
second and subsequent reviews.
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Chapter 5 INGREDIENT STATEMENT
I. INTRODUCTION
This chapter covers the ingredient statement and footnotes sections of the label, which must
contain, as provided in 40 CFR 156.10(g), the name and percentage by weight of each active
ingredient, the total percentages by weight of all "Other Ingredients,"and substatements including,
but not limited to: the acid equivalent, elemental equivalent, toxic ingredients, petroleum distillates,
sodium nitrite, and corrosivity. If the pesticide contains arsenic, in any form, a statement of the
percentages of total and water-soluble arsenic calculated as elemental arsenic. 40CFR 156.10(g)
II. WHAT IS INCLUDED IN AN INGREDIENT STATEMENT
A. FORMAT. The label reviewer must review the proposed label for a clear and prominent
ingredient statement which contains the name and the percentage of each active ingredient, and the
total percentage of all "inert"or "other" ingredients, in the pesticide and if arsenic is present, a
statement of the percentages of total and water-soluble arsenic calculated as elemental arsenic. 40
CFR156.10(g). The ingredient statement must be presented clearly, and be neither obscured nor
crowded by surrounding text. 40 CFR 156.10(a)(2) and (ii). Unless the ingredient statement is a
complete analysis of the pesticide, the term "analysis" must not be used as a heading for the
ingredient statement. 40 CFR 156.10(g)
B. ACTIVE INGREDIENT. Under 40 CFR 152.3, active ingredient means any substance (or
group of structurally similar substances if specified by the Agency) that will prevent, destroy, repel,
or mitigate any pest, or that functions as a plant regulator, desiccant, or defoliant, within the meaning
of FIFRA section2(a), except as provided in 40 CFR 174.3.
C. INERT INGREDIENT. Under 40 CFR 152.3, inert ingredient means any substance (or
group of structurally similar substances if designated by the Agency) other than an active ingredient
which is intentionally included in a pesticide product, except as included in 40 CFR 174.3. Some
examples of ingredients that may be inert ingredients include: solvents, stabilizers, spreaders or
stickers, preservatives, surfactant, defoamers, etc.
1. PR Notice 97-6 sets forth the Agency's policy concerning the use of "inert" on the label
ingredients statement. Under this policy, applicants and registrants are permitted to substitute the
heading "Other ingredients" for the heading "Inert ingredients."
D. CONTENTS. The name and nominal concentration expressed as a percentage by weight
of each pure active ingredient must be placed under the ACTIVE INGREDIENT heading and the
total percentage by weight of all inert/other ingredients must be placed under the heading INERT
INGREDIENT or OTHER INGREDIENT (or plural forms of these terms when appropriate).
Ingredient Statement
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E. HEADINGS. The headings "ACTIVE INGREDIENT" and "OTHER [INERT]
INGREDIENT" (or plural forms of these terms when appropriate), must be the same type size,
aligned to the same margin and equally prominent. PR Notice 97-6 recommends "OTHER
INGREDIENT" instead of "INERT INGREDIENT," but either may be used. Additionally
formatting requirements are set out at 156.10(g)(2)(ii) which provides that the "text of the ingredient
statement 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."
F. PERCENTAGES. The percentages shall be stated in terms of weight-to-weight and the sum
of percentages of active and inert ingredients shall be 100. Percentages shall not be expressed by
a range of values as 22-25%. 40 CFR152.10(g)(4). The percentages of active and other ingredients
must be aligned by the decimal point.
G. EXPANDED INERT STATEMENTS. Registrants are encouraged to disclose on the label
the inert/other ingredients in their pesticide product either by chemical name or functional category
with a brief explanatory definition with percentage. For example:
Other Ingredients 92.8%
Purified water, glycerin (to help keep from freezing), surfactant (to keep the
active ingredient dispersed in water)
H. It is recommended that the percentage of active and other ingredients be aligned by the
decimal point.
III. LOCATION OF INGREDIENT STATEMENT
A. FRONT PANEL. The ingredient statement is normally required to appear on the front panel
of the label unless the Agency determines that doing so is impractical. Some examples might be if
the pesticide package is extremely small or irregular in shape to the point of making it difficult to
place the ingredient statement on the front panel of the label. In such cases, permission may be
granted, upon written request (as part of the application), for the ingredient statement to appear on
the back or side panel of the label. See 40 CFR 156.10(g)(2)(i).
B. LOCATION ON FRONT PANEL. The preferred location for the ingredient statement is
immediately below the product name. (Refer to the sample label formats in chapter 3).
C. OUTSIDE WRAPPERS. If there is an outside container or wrapper through which the
ingredient statement cannot be clearly read, the ingredient statement must also appear on the outside
container or wrapper. See 40 CFR 156.10(g)(2)(i).
IV. NAMES TO BE USED IN THE INGREDIENT STATEMENT
A. FIRST STEPS. The label reviewer must review the names for ingredients used on the
proposed label and cross-reference the names in the OPPIN database on the LAN. If none of the
Ingredient Statement
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names are included in OPPIN, perhaps the chemical name of the active ingredient is new or the
registrant used an inappropriate name. If so, check with your PM/team leader for the correct
procedures to follow. Look at each section below to determine the correct names to be used in the
ingredient statement.
B. COMMON NAME
1. The name used for each ingredient shall be the accepted common name, if there is one,
followed by the chemical name. 40 CFR 156.10 (g)(3). Through PR Notice 97-5, the Agency
clarified what it considers as acceptable common names. EPA will permit the use of common names
approved by the American National Standards Institute (ANSI) in the label ingredients statement
without the accompanying scientific chemical names, and will permit the use of other common
names listed in PR Notice 97-5 without the accompanying scientific chemical name. When a
common name only appears on the label, EPA also recommends the inclusion on labels of Chemical
Abstracts Service (CAS) numbers to identify ingredients definitively.
2. The label reviewer should check OPPIN to determine the accepted common name.
"(ANSI)" or a "C" in the TYPE column will be shown with the accepted common name in the
Chemical Name list. An additional source for this information on older chemicals is the EPA
publication, Acceptable Common Names and Chemical Names for the Ingredient Statement on
Pesticide Labels, 4th edition (December 1979).
3. A list containing some of the common/chemical names may also be found in the
Pesticide Tolerance Commodity/Chemical Index section in the back of the CFR volume containing
the FIFRA regulations 40 CFR 150-189. Because this list only includes names for chemicals with
tolerances, it is only a secondary source. Similarly, a list of some common/chemical names can be
found in PR Notice 97-5.
C. CHEMICAL NAME
1. If the active ingredient has a common name, but not one that is considered "accepted"
the full chemical name must be used in conjunction with a common name 40 CFR 156.10(g)(3). For
example:
Acephate (0,S-dimethyl acetylphosphoramidothioate)
2. EPA requests that chemical names be consistent with the nomenclature used in the
Chemical Abstracts (CA) Chemical Substance Index, published by the American Chemical Society.
OPPIN reflects the correct chemical name: the entry found with the "9CI" (i.e., Ninth Collective
Index) designation at the end of the name. [OPPIN tip for label reviews: hit the Enter key on the
chemical name to see the complete chemical name, which may not appear on the line if the name
is too long to fit on the line.]
Ingredient Statement
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D. CAS (CHEMICAL ABSTRACTS SERVICE) NUMBER. The CAS number for the active
ingredient(s) may be used on the label in connection with the ingredient statement. If the CAS
number is used, it should appear as a sub-statement (footnote) to the ingredient statement and not
in any way detract from the ingredient statement.
E. MICROBIAL NAME. If the active ingredient is a microbial agent, the Agency requests that
the microbial agent be identified by genus and species (and if appropriate also by subspecies and/or
isolate number). Again, this name should be identical to the name shown in REFS.
F. DESCRIPTIVE NAME. Descriptive names approved by the Agency may be used in the
ingredient statement if there is no accepted common name and no distinctive chemical name.
Examples are: "Tobacco dust," "Egg solids," or "Dried blood." Approved descriptive names are
listed in REFS, and the name shown on the proposed label must be identical to the name found in
REFS.
G. TRADEMARK NAME. A trademark or proprietary name may not be used in the ingredient
statement unless it has been accepted as a common name by the Administrator under the authority
of FIFRA Section 25(c)(6). See 40 CFR 156.10(g)(3).
V. CRITERIA FOR DETERMINATION OF PESTICIDAL ACTIVITY
A. IS THE INGREDIENT CONSIDERED TO BE ACTIVE
1. The criteria for determination of an ingredient's active or inert status are located in
40 CFR 153.125 and PRNotice 81-4. Generally speaking an ingredient will be considered an active
ingredient if, by itself, and when used as directed at the proposed use dilutions, it has the capacity
to function as a pesticide or has the ability to elicit or enhance the effect of another compound whose
pesticidal activity is substantially increased due to the interaction of the compounds. Ingredients
such as stickers and other adjuvants which function simply to enhance or prolong the activity of an
active ingredient by physical action are not generally considered to be active ingredients.
2. A chemical may be an active ingredient in one formulation and an inert ingredient in
another. Examples are chemicals used as preservatives of a formulation, plant nutrients, or chemicals
with some other non-pesticidal use.
B. RELATED COMPOUNDS (ACTIVE). As described in PR Notice 81-4, EPA recommends
that related compounds that are now distinguishable from the intended active ingredient(s) due to
newer, more discriminating methods of analysis must be accounted for within the pesticide label
ingredients statement. If one or more related compounds is isolated and found to have pesticidal
activity to the target pest, EPA requests that it be specifically identified and quantified by percentage
under the ACTIVE INGREDIENT heading of the label ingredients statement. For example:
Ingredient Statement
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ACTIVE INGREDIENTS:
2-Carbomethoxy-l-methylvinyl dimethyl phosphate, a isomer 20.0%
2-Carbomethoxy-l-methylvinyl dimethyl phosphate, p isomer 3.0%
OTHER INGREDIENTS: 77.0%
Total 100.0%
C. RELATED COMPOUNDS (INERT). Related compounds whose active/inert status is
not determined by the registrant, must be included (without designation as related compounds or by
name) under the total percentage of the INERT INGREDIENT or OTHER INGREDIENT heading
(see PR Notice 81-4).
D. EQUIVALENTS: Unless declared as an active ingredient, a related compound must not
be included in expressing percent acid or metallic equivalents, nor in the declaration of "pounds
active ingredient" or "acid (or metallic) equivalents per gallon" under the ingredient statement. (PR
Notice 81-4).
VI. STATEMENT OF CONCENTRATIONS
A. DEFINITION. The percent nominal concentration specified in the ingredient statement
on the label must be stated as the nominal concentration of such ingredient(s),as that term is defined
in 40 CFR 158.153(i). The nominal concentration is the amount of an ingredient which is expected
to be present in a typical sample of a pesticide product at the time the product is produced, expressed
as a percentage by weight. The nominal concentration is the only acceptable method for expressing
the percentage of active ingredient in the product. All pesticide ingredient statements must be
expressed as nominal concentration.
B. EXPRESSIONS
1. Reviewers of proposed labels for products subject to deterioration, such as sodium
hypochlorite, should note Section IX (Deterioration), below.
2. The percent of the pure active ingredient in a technical grade product is the same
as its nominal concentration. This must be indicated in Columns 10 and 13b of the CSF.
3. The nominal concentration in a formulated product is a function of the percentage
by weight of the active ingredient in the product (including associated ingredients) and the purity
of the source product (its nominal concentration). For example:
If the purity of the active source is 80%, as declared in column 10 of the CSF, and
the percentage by weight of the active ingredient in the formulated product is 20%
as indicated in column 13(b) of the CSF, the nominal concentration of the product
would be 16% (20% x 0.80), consistent with the label claim. The 16% nominal
concentration can be indicated between parentheses in the same column below the
20%w/w.
Ingredient Statement
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4. If wider limits for active and inert ingredients were justified as per the regulations
40 CFR 158.175 (c) which case the proposed upper and lower certified limits must be indicated on
the Confidential Statement of Formula (CSF) and the guarantee of each active ingredient in percent
must be indicated on the label. The guarantee is the label claim nominal concentration, a value
between the upper and lower certified limits, not equal to either value.
5. The sum of the percentage by weight of the active ingredient and intentionally
added inert/other ingredients in a formulated product must be equal 100%. In a technical grade of
active ingredient, the total of all nominal concentrations of the pure ingredient plus associated
ingredients, including impurities, must be >98%.
6. For ingredient statements which reflect the fact that the active ingredient is the
only component of the product, the inert ingredients header is not necessary. For example, for a
product which is 100% pure chlorine gas, the following ingredient statement is acceptable:
ACTIVE INGREDIENT:
Chlorine 100.0%
Assuming that the chlorine gas is only 99% pure, then the following ingredient
statement would be required:
ACTIVE INGREDIENT:
Chlorine 99.0%
OTHER INGREDIENTS 1.0%
7. If the proposed label is for a liquid formulation, the label reviewer must check the
Directions For Use section. If any of the use directions of the pesticide product are expressed as a
certain weight of active ingredient per unit area (such as pounds per acre), a statement of the weight
of the active ingredient per unit volume of the pesticide formulation must also appear at the end of
the ingredient statement. See 40 CFR 156.10(g)(4). This is very important when calculating the use
rates. An example of this would be, "One gallon contains 4 pounds of the active ingredient
(chemical)." If dosage rates in the directions for use are expressed as weight of product/unit area,
the weight of the product/gallon must be stated.
VII. SUBSTATEMENTS (FOOTNOTES)
Based on historical practice, EPA requests the following footnotes appear on the label, as
applicable:
A. PETROLEUM DISTILLATES. Products containing petroleum distillates, xylene or
xylene range aromatic solvents at > 10% should be indicated on the label immediately below
the ingredient statement as a footnote below the term "Inert ingredients" or "Other
Ingredients" as follows:
"Contains petroleum distillates, xylene or xylene range aromatic solvents."
Ingredient Statement
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B. INGREDIENTS OF TOXICOLOGICAL CONCERN. Products containing ingredients
of toxicological concern should be indicated on the label immediately below the ingredient statement
as a footnote below the term "Inert Ingredients or "Other Ingredients" as follows:
"This product contains the toxic ingredient (name of ingredient), at...% (indicate the
upper certified limit of the toxic component in percent).
C. SODIUM NITRITE. Products containing sodium nitrite at >0.1% should indicate in the
ingredient statement as a footnote below the term "Inert Ingredients"(or "Other Ingredients") as
follows:
"This product contains sodium nitrite."
VIII. DETERIORATION
A. GENERAL LABELING. In cases where it is determined that a pesticide formulation
changes chemical composition significantly overtime, the product must bear the following statement
in a prominent position on the label: "Not for sale or use after [date]." (40 CFR 156.10(g)(6)(i))
Note the product must meet all label claims up to the expiration time indicated on the label.
B. SODIUM HYPOCHLORITE. For sodium hypochlorite products containing 5.25 -12.5%
active ingredient, the Agency historic practice has been that instead of an expiration date on the
label, the following labeling statement is necessary to ensure the product is effective (because of its
rapid degradation).
"Degrades with age and exposure to sunlight and heat. Use a test kit
and increase dosage as necessary to obtain the required level of
available chlorine."
IX. SPECIFIC DESIGNATIONS FOR SOME INGREDIENT STATEMENTS
A. Some pesticide ingredients require specific designations on the ingredient statement for
proper clarification and identification. Examples of some of these specific designations are shown
below:
1. Microbial Pesticides. Biopesticides are generally subject to the same labeling
provisions as conventional pesticides. They are viewed essentially the same as chemical pesticides
with respect to label requirements, except for differences with the ingredient statement.
a. Products containing live microorganisms the agency has historically
required that the label indicate the equivalent number of viable units (spores, cells, colony forming
units, etc.) per unit weight or volume of product.
Ingredient Statement
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b. For Bacillus thuringiensis (Bt) products, the Agency has historically
required the following labeling information. The active ingredient declaration must be based upon
percent by weight of insecticidal toxin(s) present. Strain variety, as well as percent active ingredient
declared for each order of insects affected, must appear on the label. (PR Notice 72-6). The use of
potency units expressed in terms of International Units (IU) per milligram of product is required
unless the percent toxin has been shown to predict field activity. If used, it should appear on the
label below the ingredient statement and should be followed by the statement "Potency units should
not be used to adjust use rates beyond those specified in the Direction for Use section." For example:
ACTIVE INGREDIENTS:
Bacillus thuringiensis subspecies kurstaki
Lepidopteran active toxin 3.0%
Dipteran active toxin(s) 2.0%
OTHER INGREDIENTS: 95.0%
Total 100.0%
Potency: 40,000 International Units per milligram of this product. Potency units
should not be used to adjust rates beyond those specified in the Directions for Use
section.
Because the reregi strati on data on percentage of active ingredients have not
been reviewed for Bt products, labels for many Bt products still list the percentage a.i. based on
potency. For potency based ingredient statements for lepidopteran active Bt products, would
indicate 500,000 International Units (IU)/mg product = 100% active ingredient. Percent active
ingredient is calculated on the product potency compared to the 100% active ingredient assumption
of 500,000 IU/mg. Thus, a 16,000 IU/mg product would be (16,000/mg) x (100%/500,000 IU/mg)
= 3.2.%.
(1) Subdivision M (Pesticide Testing Guidelines) Microbial and
Biochemical Pest Control Agents (July 1989) addresses this topic. Certified limits can be expressed
as:
(a) Microbial Pest Control Agents (MPC A) units/unit weight
or volume
(b) International Units of Potency per unit weight
(c) Weight percent of product
Items (a) and (b) may be expressed using biological, genetic, biochemical, serological or other
appropriate data. For example:
ACTIVE INGREDIENT:
Pseudomonas cepacia type Wisconsin 3.8% (by wt.)
OTHER INGREDIENTS: 96.2% (by wt.)
Total 100.0% (by wt.)
Contains at least 50 million viable cells/lb (105 cells/gram).
Ingredient Statement
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ACTIVE INGREDIENTS:
Trichoderma harzianum (ATCC 20476) 16.6% WAV
Trichodermapolysporum (ATCC 20475) 16.6% WAV
OTHER INGREDIENTS: 66.8.% WAV
Total 100.0% WAV
Minimum 4.5 million colony forming units (CFU) per pound (454 grams)
2. Biochemical Pesticides. The ingredients statement for a product for which the
active ingredient is a naturally occurring plant regulator, (such as cytokinins, auxins, or gibberellins)
and for which quantitative chemical methods and units are not available, must be stated in an
acceptable and generally recognized bioassay unit. For example:
ACTIVE INGREDIENT:
Cytokinin (equivalent to 200 ppm kinetin activity) 3.0%
OTHER INGREDIENTS: 97.0%
Total 100.0%
3. Pheromone Products. The ingredient statement for pheromone dispenser labels
shows the pheromone in mg. per dispenser as a footnote. This must be as reflected in the CSF.
ACTIVE INGREDIENT:
Pheromone* 1.0%
OTHER INGREDIENTS: 99.0%
Total 100.0%
*x mg per dispenser
4. Insect Virus-based Insecticides. Pesticide products containing an insect virus as
the active pesticide ingredient must indicate the number of activity units (polyhedral inclusion
bodies for nuclear polyhedrosis viruses or capsules for granulosis viruses) per gram (106 PIBS/gm)
or percentages (%). For example:
BIOCONTROL-l
Biological Insecticide for the Control of Douglas Fir Tussock Moth
ACTIVE INGREDIENT*:
Polyhedral Inclusion Bodies of Douglas Fir
Tussock Moth Nuclear Polyhedrosis Virus 13.5%
OTHER INGREDIENTS 86.5%
Total 100.0%
*Contains at least 70 million activity units per gram.
Ingredient Statement
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Often the active ingredient statement will include "... and insect body parts..." whether the
baculovirus is propagated in vivo or in vitro. For example:
SPECIFIC-T-l
ACTIVE INGREDIENT:
Granulosis Virus of Cydia Pomonella (Coddling Moth)
(at least 5 x 108 GIBS/ml) 0.005%
OTHER INGREDIENTS: 99.995%
Insect parts/water/inert solids 99.985%)
Aureomycin (5.5%) 0.015%)
Total 100.000%
5. Salts, Amine or Ester of Acids. If the active ingredient is a salt, amine or ester
of an acid, the label must declare in a substatement under the ingredient statement the percentage
equivalent of the acid. For example:
ACTIVE INGREDIENTS:
Isooctyl ester of 2,4-Dichlorophenoxyacetic acid* 12.0%
Isooctyl ester of 2-(2,4-Dichlorophenoxy) propionic acid** 10.0%
OTHER INGREDIENTS: 78.0%
Total 100.0%
*2,4-Dichlorophenoxyacetic acid equivalent, 9.5%
**2-(2,4-Dichlorophenoxy)propionic acid equivalent, 9%
6. Copper and Zinc Salts or Complexes. Pesticide products for which the active
ingredients are copper salts or complexes must declare the chemical name of the copper complex
as active ingredient and the equivalent metallic copper declared in a substatement. For example:
ACTIVE INGREDIENT:
Copper naphthenate* 93.2%
OTHER INGREDIENTS: 6.8%
Total 100.0%
*Metallic copper equivalent, 22%
This type ingredient statement declaration is also applicable to zinc. For example, zinc naphthenate
must be expressed as percent metallic zinc equivalent.
7. Brominated and/or Chlorinated Compounds. Certain brominated or chlorinated
compounds may require a reference in the ingredient statement to the available chlorine or bromine.
For example:
ACTIVE INGREDIENT:
l-Bromo-3-chloro-5, 5-dimethylhydantoin 86.4%
l-3dibromo-5, 5-dimethylhydantoin 8.6%
OTHER INGREDIENTS: 5.0%
Total 100.0%
Provides: 66.8% Available Bromine
25.4% Available Chlorine
Ingredient Statement
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8. Metal Ion Exchange Resins: Any metal (e.g., Ag or Cu) used as pesticide, when
bound to an ion exchange resin, must be declared on the label as the percent metallic equivalent with
a footnote immediately below the ingredient statement specifying the identity and amount of the ion
exchange resin which was used.
9. Sodium Chlorate Products: Because sodium chlorate is extremely flammable, all
pesticide products containing sodium chlorate must include a fire retardant in the formulation.
These labels must bear in the vicinity of the ingredient statement, a statement indicating that the
product contains a fire retardant. If the proposed label is a sodium chlorate product, check the CSF
to verify that the product contains a fire retardant (column 15, Purpose in Formulation).
10. Arsenic Containing Products: Pesticide products which contain arsenic in any
form must include a sub statement of the percentages of total arsenic and water-soluble arsenic
calculated as elemental arsenic. See 40 CFR 156.10(g)(1). For example:
"Total arsenic, all in water soluble form, expressed as elemental = xx%"
11. Products with Petroleum Distillates: Formulations containing greater than or
equal to 10% petroleum distillates, xylene, or xylene range aromatic solvent must reflect the
statement "Contains petroleum distillates, xylene, or xylene range aromatic solvent" immediately
below the ingredient statement as a footnote to the inert ingredients.
12. Fertilizer-pesticide Combinations: Pesticides that are formulated in combination
with fertilizers must bear an ingredient statement the same as any other pesticides. The fertilizer
composition must be separate from the pesticide ingredient statement and must not detract from or
obscure the required pesticide labeling statements.
13. Complexing Agents: In products containing an active ingredient bound with other
agents as a complex, the active ingredient, must be declared in the ingredient statement with a
footnote immediately below the active ingredient statement listing the complex formed. In the case
of complexed iodine, for example, the active ingredient is titratable iodine.
ACTIVE INGREDIENT:
Iodine*
OTHER INGREDIENTS:
Total
*from (name of complexing agent)
X. INERT INGREDIENTS
A. SPECIAL LABELING REQUIREMENTS FOR INERTS OF TOXICOLOGICAL
CONCERN (LIST 1). Products containing one or more other/inert ingredients on List 1 (inert
ingredients of toxicological concern) have historically been required to include on the label the
statement: "This product contains the toxic inert ingredient (name of inert)." See Inert Ingredients
in Pesticide Products; Policy Statement OPP-36140;FRL-3190; 40 CFR 156(g)(7). This statement
must be placed in close proximity to the ingredient statement in a type size comparable to other front
15.0%
85.0%
100.0%
Ingredient Statement
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panel text. (Refer to chapter 13 also) For enforcement purposes applicants have been asked to
indicate on the label the "maximum" percent of ingredients of toxicological concern characterized
in the product. PRNotice 90-1, issued May 1, 1990, revised and modified previous published lists
of inert ingredients in pesticide products that are of toxicological concern and require priority
testing. In general, after the PRNotice was issued EPA did not register any new products containing
a List 1 inert. The most current inert list is available on the
Web: http://www.epa.gov/opprd001/inerts. The list of seven inert ingredients is as follows:
LIST 1. -- INERTS OF TOXICOLOGICAL CONCERN
( \S \n
('IiciiiicmI Vimc
50-00-0
Formaldehyde
78-59-1
Isophorone
81-88-9
Rhodamine B
108-95-2
Phenol
117-84-0
Diocytl phthalate
123-31-9
1,4-benzendiol
25154-52-3
Nonylphenol
B. IDENTIFICATION OF INERT/OTHER INGREDIENTS. Inert ingredients are not
required to be identified individually in the ingredient statement except when EPA determines that
such inert ingredient may pose a hazard to man or the environment. See 40 CFR 156.10(g)(7). In
such a situation, EPA may require that the name of the inert be listed in the ingredient statement.
However, if a registrant wants to list a particular inert ingredient in the ingredient statement the
registrant must list all inert ingredients directly below the ingredient statement.
XI. ALTERNATE FORMULATIONS
A. EPA may approve a basic formulation and one or more alternate formulations for a single
product. An alternate formulation must meet the criteria listed in 40 CFR 152.43(b)(1) through (4).
The Agency may require the submission of data to determine whether the criteria have been met.
Registrants are encouraged to keep their alternate formulas, if any, up-to-date. The label text of the
alternate formulation product must be identical to that of the basic formulation. The Agency will
not approve an alternate formulation if the alternate formulation requires a change in the label text.
B. The alternate formulation must have the same certified limits for each active ingredient
as the basic formulation. 40 CFR 152.43(b)(1)
Ingredient Statement
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C. If the alternate formulation contains an inert ingredient or impurity of toxicological
significance, the formulation must have the same upper certified limit for that substance as the basic
formulation.
D. The analytical method required under 40 CFR 158.180 must be suitable for use on both
the basic formulation and the alternate formulation.
E. Alternate formulas, should be clearly marked "Alternate Formula A," "Alternate B," etc.
Further, indication that an alternate formula is replacing "alternate formula x" or "is in addition to
"alternate formula y" would reduce confusion.
F. Except for approved dye substitutions, EPA does not accept alternate formulations for
rodenticides.
Ingredient Statement
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Chapter 6 USE CLASSIFICATION
I. INTRODUCTION
End -use pesticide products (as opposed to products solely for further formulation into other
pesticides (See 40 CFR 152.166)) maybe classified as Restricted Use Pesticides (RUP), or general
use, or may be unclassified. 40 CFR 152.160(a). The Agency does not normally classify products
for general use; products that are not restricted remain unclassified. See 40 CFR 152.160(a). If the
Agency determines that the pesticide, when applied in accordance with the label's directions for use,
warning and cautions may generally cause, without additional regulatory restrictions, unreasonable
adverse effects, the Agency will classify the pesticide as an RUP. See FIFRA 3(D)(1)(c). The policy
that drives this classification is that when labeling cannot sufficiently mitigate the risk, special
training in handling and applying the pesticide product is necessary to ensure the safe use of the
product. The sale and distribution of RUPs must be conducted pursuant to the regulations set out
at 40 CFR 152.167, or is subject to restrictions promulgated through Agency regulation. FIFRA
3(d)(l)(C)(i)&(ii). The use of RUPs is limited to certified applicators or persons under their direct
supervision. Use of unclassified products is not limited in any manner unless the labeling limits use
to a specific definable group, (e.g., veterinarians).
II. UNCLASSIFIED PRODUCTS
A. CRITERIA. While there are no specific criteria for determining if a product is unclassified,
the following issues can help a label reviewer perform that assessment:
1. Me-too. The product under review is a me-too registration, and the product cited as
substantially similar is unclassified.
2. Data Supported. The product under review is a new product for which data were
submitted and none of the following data reviews indicates that the product should be considered
for restricted use classification.
a. Environmental Effects, Fate and Groundwater reviews assess the toxicity to fish, birds
and mammals, and endangered species and assess the possibility of groundwater contamination and
persistence in soil.
b. Chemistry and Exposure reviews assess the degree of human health exposure.
c. Toxicity reviews assess the acute and chronic toxicity of the product, and the acute and
chronic human health hazards.
3. MPs. The product under review is a manufacturing use product (MP). MPs are not
subject to the 40 CFR 152.166 restricted use labeling requirements.
Use Classification
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4. AI's not previously restricted use. The product under review contains no active
ingredient(s) or use(s) which have been previously classified as restricted use. To check: Refer to
40 CFR 152.175. Another reference source for this information is the Webpage:
www.epa.gov/opppmsdl/RestProd/. Note that under 40 CFR 152.170(d), there may be other
evidence such as field studies or monitoring data that would result in the Agency determining that
a pesticide should be restricted use.
If the label under review meets any of the above criteria, then the product is unclassified. If
the label under review does not meet one of the above criteria, then the product may be classified
as an RUP.
III. RESTRICTED USE PESTICIDES (RUP)
A. DETERMINATION OF CLASSIFICATION. Review the criteria below to determine
whether the product should be classified as an RUP.
1. If the product under review is a me-too registration and the cited product is classified as
an RUP, then the product label under review must bear the Restricted Use classification. Go to
section B below on "Labeling Requirements for an RUP."
2. Based on a review of the data that support the product registration, the pesticide may be
classified as RUP if its toxicity exceeds the specific hazard criteria set out at 40CFR 152.170. Even
if the RUP criteria are triggered, the label reviewer should check with the Product Manager/team
leader to determine if the potential risk can be adequately mitigated through additional labeling
restrictions. See 40 CFR 152.170(e). If not, the product must be classified as an RUP. Go to
Section 3 below on "Labeling Requirements for RUPs." If the PM/team leader determines that the
product should not be classified as an RUP because additional label language can mitigate the risk,
then the label reviewer must include a memo to the file noting this decision. The memo must
specify the basis for the decision under 40 CFR 152.170(e), including the alternative labeling
language required. The label reviewer must sign and date the memo and place it in the registration
jacket. The label reviewer should make sure the product label under review does not bear any use
classification.
B. LABELING REQUIREMENTS FOR RUPS. Restricted use pesticides are subject to the
labeling requirements specified of 40 CFR 156, including the requirements set out at 40 CFR
156.10(j)(2) described further in PRNotice 93-1. The product may have both general and restricted
uses. If there is a restricted use, the labeling requirements for restricted use must be followed.
Check the label under review to make certain that the label meets the RUP labeling requirements
listed below:
1. The statement "Restricted Use Pesticide" must appear at the very top of the label's front
panel, 40 CFR 156.10(j)(2)(i). No other wording or symbols should appear above the RUP
statement. PRNotice 93-1.
Use Classification
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2. The Agency requests that the RUP statement be followed by the reason for RUP
classification. (40 CFR 156.10(j)(2)(i)). (See the next section below for examples of chemical-
specific RUP statements and reasons for RUP classification).
4. The RUP statement should be enclosed in a box to enhance its visibility on the label. PR
Notice 93-1.
5. The RUP statement must appear with sufficient prominence in relation to other label text
and graphics so as not to be overlooked. (40 CFR 156.10(j)(2)(i)(A)).
6. The label must bear the phrase "Restricted Use Pesticide" under the heading "Directions
for Use" See 40 CFR 156.10 (i)(2)(i).
7. The phrase "Restricted Use Pesticide" must meet the minimum type size requirements of
the human hazard signal words. 40 CFR 156.10(j)(2)(i). If type size is too small, the label reviewer
must notify the registrant in writing of the type size requirements specified in the Code of Federal
Regulations at 40 CFR 156.10(h)(l)(iv) for the signal word.
8. The label must not bear any designation indicating that certain uses are restricted and
other uses are not restricted. If the registrant wants to include unrestricted uses on a product with
restricted uses then the entire product must be labeled restricted. This is to avoid the general public
obtaining access to products with restricted uses. If the registrant desires to market uses as
unrestricted, then the registrant must seek a separate label only for those unrestricted uses. [40 CFR
156.10(j)(2)(i).]
C. WORDING OF THE RUP TERMS OF RESTRICTION. The label must bear the general
summary statement of the terms of restriction at top of the front panel (40 CFR 156.10(j)(2)(i)(B)).
See Chapter 3 for correct formats.
1. If use is restricted to certified applicators, the general RUP statement listed at 40 CFR
156.10(j)(2)(i)(B) must appear as follows: "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 pesticides require a specific RUP statement, based on specific case-by-case risk
management decisions. The Agency in some cases has determined that particular RUP statements
are applicable to specific products or to the active ingredient(s). Check the appropriate science
review, and consult your Product Manager or Team Leader to determine if a specific RUP statement
has been applied to particular products or active ingredients. Then evaluate whether the particular
product at issue requires that same or similar language based on risk management issues and the
FIFRA statutory standard of unreasonable adverse effects. Also, check in OPPIN or the Chemical
Review Manager/Team Leader for the status of the Reregi strati on Eligibility Decision (RED)
document for the chemical. If a RED document has been issued, check it for any specific guidance
for Restricted Use Pesticide classification and/or associated labeling. NOTE: Additional specific
Use Classification
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RUP statements will be added to the manual as they are identified. Following are some examples
of RUP statements. The format for specific RUP statements and examples of chemical-specific
statements that the Agency has historically used are set out below:
"Restricted Use Pesticide [Same minimum type size as signal word]"
"Due to [reason for restricted use]"
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.
a. Acetochlor
"Due to Oncogenicity. 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."
b. Acrolein
"Due to high toxicity. 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."
c. Alachlor
"Due to Oncogenicity. 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."
d. Aldicarb (Temik® brand)
"Acute Oral Toxicity and Ground Water Contamination. 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."
e. Azinphos-Methyl (Guthion™)
"Due to acute toxicity. 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."
Use Classification
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f. Creosote
"Due to carcinogenicity. 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."
g. Diclofop-methyl
"Due to oncogenicity in laboratory mice. 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."
h. Diazinon
"Due to Avian and Aquatic Toxicity. 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."
i. Fortress™
"Due to Acute Human, Avian and Aquatic Invertebrate Toxicity. 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."
j. Hydrogen Cyanamide
"Due to corrosive effects to eyes and skin. 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."
k Hydrogen Phosphide
"Due to acute inhalation. Toxicity of highly toxic hydrogen phosphide (phosphine, PH3)
gas. For retail sale to and use only by Certified Applicators for those uses covered by the
applicator's certification or persons trained in accordance with the accompanying product
manual working under the direct supervision and in the physical presence of the certified
applicator. Physical presence means on site or on the premises. Read and follow the label
and the (manufacturer's, name of SPECIFIC MANUFACTURER) product manual which
contains complete instructions for the safe use of this pesticide."
Use Classification
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1. Isoxaflutole
"May injure (phytotoxic) susceptible non-target plants. For retail sale to and use only by
Certified Applicators or persons under their direct supervision and only for those uses
covered by the Certified Applicator's certification. Commercial and Certified Applicators
must ensure that all persons involved in these activities are informed of the precautionary
statements."
m. Oxamyl
"Due to acute toxicity and toxicity to birds and mammals. 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."
p. Methomyl
"Due to high acute toxicity to humans. 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. Direct supervision for this product requires the
Certified Applicator to review federal and supplemental label instructions with all
personnel prior to application, mixing, loading, or repair or cleaning of application
equipment."
q. Methyl Parathion (except encapsulated formulation)
"For retail sale to and use only by Certified Applicators or persons under their direct
supervision and only for those used covered by the Certified Applicator's certification.
Direct supervision for this product is defined as the Certified Applicator being present
during application, mixing, loading, repair and cleaning of application equipment.
Commercial Certified Applicators must also ensure that all persons involved in these
activities are informed of the precautionary statements."
r. Sulfuric Acid Desiccant
"Due to severe tissue corrosive action. 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."
Use Classification
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Chapter 7 PRECAUTIONARY STATEMENTS
I. INTRODUCTION
A. CONTENTS. This chapter addresses label requirements and recommendations for those
parts of the Precautionary Statements related to human health and is organized into the following
sections:
Introduction
Background
Documents Used to Determine Labeling
Acute Toxicity Data
Determining the Precautionary Labeling
The Signal Word, Poison, Skull and Crossbones, and Child Hazard Warning
The Hazards to Humans and Domestic Animals Statements
Personal Protective Equipment (PPE)
The First Aid Statements
Labeling Options
Use Dilutions
Other Deviations
B. PURPOSE OF STATEMENTS. The precautionary statements are designed to provide the
pesticide user with information regarding the toxicity, irritation and sensitization hazards associated
with the use of a pesticide, as well as treatment instructions and information to reduce exposure
potential. While the Precautionary Statements include Personal Protective Equipment (for uses that
trigger worker protection standards), User Safety Requirements, Engineering Controls, User Safety
Recommendations, Environmental Hazards, and Physical or Chemical Hazards, for the purposes
of this manual, those topics are addressed in other chapters. The remaining sections (Signal Word,
Child Hazard Warning, Hazards to Humans and Domestic Animals, First Aid and Personal
Protective Equipment [Non-Worker Protection Standard (WPS)] are fully addressed in this chapter.
Label reviewers should consult the mandatory/advisory PR Notice 2000-5 for guidance in
recommended language for precautionary statements.
II. BACKGROUND INFORMATION
A. DOCUMENTS USED TO DETERMINE CONTENTS OF PRECAUTIONARY
STATEMENTS ON LABELS. The Code of Federal Regulations specifies both the acute toxicity
category endpoints [40 CFR 156.62] and the Hazards to Humans and Domestic Animals statements
associated with each toxicity category [40 CFR 156.70], These toxicity categories and labeling
statements, however are not currently being used by the Agency, because they are less detailed and
provide less protection for pesticide users than other guidance. The 40 CFR 156.70(c) states that
specific statements pertaining to the hazards of the product and its uses must be approved by the
Agency. The labeling statements provided in the Federal Register Notice issued on 9/26/84, entitled
Proposed Rule on Labeling Requirements (Volume 49, Number 188) have been used by the Agency
for the past twenty years. The acute toxicity categories listed in the Proposed Rule are also being
Precautionary Labeling
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used with one exception. The acute inhalation toxicity category endpoints currently used are from
a 2/1/94 Health Effects Division paper entitled "Interim Policy for Particle Size and Limit
Concentration Issues in Inhalation Toxicity Studies."
B. ACUTE TOXICITY DATA. The Signal Word, Hazards to Humans and Domestic Animals,
Personal Protective Equipment (non-WPS) and First Aid statements are typically determined by the
results of the six acute toxicity studies performed with the product formulation. The acute oral,
acute dermal and acute inhalation studies evaluate systemic toxicity via the designated routes of
exposure. The primary eye irritation and primary skin irritation studies measure irritation or
corrosion, while the dermal sensitization study evaluates the potential for allergic contact dermatitis.
With the exception of dermal sensitization, each acute study is assigned to a toxicity category based
on the study results (See Table 1 below). The results of these six acute toxicity studies must be
known in order for the appropriate labeling language to be determined.
Table 1 - Toxicity Categories
Study
Category I
Category II
Category III
Category IV
Acute Oral
Up to and including
50 mg/kg
> 50 thru 500
mg/kg
> 500 thru 5000
mg/kg
> 5000 mg/kg
Acute
Dermal
Up to and including
200 mg/kg
> 200 thru 2000
mg/kg
> 2000 thru
5000 mg/kg
> 5000 mg/kg
Acute
Inhalation1
Up to and including
0.05 mg/liter
> 0.05 thru 0.5
mg/liter
> 0.5 thru 2
mg/liter
> 2 mg/liter
Primary
Eye
Irritation
Corrosive
(irreversible
destruction of ocular
tissue) or corneal
involvement or
irritation persisting
for more than 21 days
Corneal
involvement or
other eye irritation
clearing in 8-21
days
Corneal
involvement or
other eye
irritation
clearing in 7
days or less
Minimal
effects
clearing in less
than 24 hours
Primary
Skin
Irritation
Corrosive (tissue
destruction into the
dermis and/or
scarring)
Severe irritation at
72 hours (severe
erythema or
edema)
Moderate
irritation at 72
hours (moderate
erythema)
Mild or slight
irritation at 72
hours (no
irritation or
slight
erythema)
1 4 hr exposure
Precautionary Labeling
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C. USE OF REDs. During Reregi strati on, the Reregi strati on Eligibility Decision (RED)
document may also specify personal protective equipment, engineering controls and user safety
recommendations. In cases where RED specifications differ from those determined by the acute
toxicity categories, the most protective statements must be employed. The regulations allow use of
a higher signal word for human hazard when necessary to prevent unreasonable adverse effects on
man and the environment. 40 CFR 155.10(l)(i)(E).
III. DETERMINING THE PRECAUTIONARY LABELING
A. THE SIGNAL WORD
1. When Required. A Signal Word is required for all registered pesticide products unless
the pesticide product meets the criteria of Toxicity Category IV by all routes of exposure. If a signal
word is used in this case, it must be "Caution."
2. Determining the Signal Word. The Signal Word is determined by the most severe
toxicity category assigned to the five acute toxicity studies (see table 1) or by the presence of
methanol in concentrations of 4% or more. Refer to the acute toxicity data review to determine the
most severe toxicity category. Also check the Confidential Statement of Formula to determine if
methanol is present. The Signal Words and associated toxicity categories are as follows:
3. Location and Prominence. The Signal Word is required to appear on the front panel
of the label, and the Agency requests that it appear on a separate line from the required Child Hazard
Warning statement (Keep Out of Reach of Children). It is preferred that it appear below the
KOROC statement. The Signal Word is also required on any supplemental labeling intended to
accompany the product in distribution or sale. The Agency also requests that it appear in the
Precautionary Statements section immediately below the subheading "Hazards to Humans and
Domestic Animals". In cases where the "First Aid" and "Hazards to Humans and Domestic
Animals" statement appear on the front panel, the Agency requests that the Signal Word be placed
directly below the Child Hazard Warning statement, but it does not have to be repeated after the
"Hazards to Humans and Domestic Animals" statement. All required front panel warning statements
shall be grouped together on the label, and shall appear with sufficient prominence relative to other
front panel text and graphic material to assure that they will not be overlooked under customary
conditions of purchase and use [See 40 CFR 156.60(b)], See Chapter 3 for the Minimum Type Size
requirements for the Signal Word and the Child Hazard Warning statement. The Agency requests
that the Signal Word appear in all capital letters and be oriented in the same direction as other label
text.
Precautionary Labeling Page 7-3
Toxicity Category I .
Toxicity Category II
Toxicity Category III
Toxicity Category IV.
DANGER
WARNING
CAUTION
None Required
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Label Review Manual
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4. Related Information. Because of the potential for confusion, the Agency historically
has not approved labels containing the terms "caution," "warning", or "danger," except as the Signal
Word for that label (e.g., "CAUTION: Wash hands before eating, or smoking" on a label with the
signal of "Caution"). Another example is the statement required by California's Proposition 65
which normally requires the term "warning." Registrants should use the term "notice" or "attention"
instead, so that it does not conflict with the EPA required Signal Word.
B. POISON - SKULL AND CROSSBONES SYMBOL
1. When Required. The word "POISON" and the skull and crossbones symbol are
required for products classified as toxicity category I for acute oral, acute dermal, or acute inhalation
toxicity studies [40 CFR 156.64(a)(1). It is recommended if the inert, methanol, is present at 4%
or more in the subject product.
2. Location and Prominence. If required, the word "POISON" and the skull and
crossbones symbol must appear in immediate proximity to each other. The word "POISON" must
appear in red on a background of a distinctly contrasting color. If the proposed label does not
indicate these display requirements, include this requirement in your response to the registrant.
In addition, the Agency requests that the "Poison" and the skull and crossbones symbol appear near
the Tox.l signal word "Danger".
Ta
)le 2 - Signal Word and Associated Labeling ]
)etermination
Type of Study
Product A
Product B
Product C
Product D
Product E
Acute Oral
III
IV
I*
III
II*
Acute Dermal
IV
III
III
IV
II
Acute
Inhalation
III
IV
III
III
II
Primary Eye
III
II
I
I
II
Primary Skin
IV
IV
II
IV
II
Special Inert,
e.g., methanol
No
No
No
No
Yes*
CORRECT
SIGNAL
WORD
CAUTION
WARNING
DANGER
DANGER
DANGER
*Product C and Product E must also bear additional labeling (Skull & Crossbones symbol in
close proximity to the word "POISON" which must appear in red on a contrasting background).
Product C must bear the additional labeling as a result of the toxicity category I classification for
the acute oral toxicity study. Product E should bear the additional labeling because it contains a
special inert (methanol) at greater than 4%, which as described in paragraph B1. above.
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C. CHILD HAZARD WARNING STATEMENT
1. When Required. The Child Hazard Warning statement ("Keep Out Of Reach Of
Children") is required on all product labels, unless the requirement is waived. The warning
statement requirement may be waived when the registrant adequately demonstrates that the
likelihood of contact with children during distribution, storage or use (e.g., an MUP in some
situations) is extremely remote or if the pesticide is approved for use on infants or small children.
2. Location and Prominence. The Child Hazard Warning statement must appear on the
front panel [40 CFR 156.66]. It is preferred that the Child Hazard Warning appear on a separate line
above the Signal Word. If the Signal Word and Child Hazard Warning were to appear on the same
line, a pesticide user could incorrectly assume that the Signal Word is intended primarily for
children rather than as a general precaution for all persons. If the label under review has the signal
word and Child Hazard Warning on the same line, request that the registrant revise the label. Also
make sure that the Child Hazard Warning statement is oriented in the same direction as other label
text.
3. Additional Information
a. Based on the FIFRA unreasonable adverse effects standard, the Agency has not
allowed the Precautionary Statements or the Directions for Use to contain any statement which
implies that the product may be used by children. For example, draft labels of products intended to
repel insects should not contain instructions such as "Do not allow use by small children without
close adult supervision." Such labeling creates unacceptable risk issues, as it implies that a child
can apply the product as long as an adult watches.
b. A modified Child Hazard Warning statement may be used for products where child
contact is expected during normal use. For products requiring a modified statement, make sure that
the statement is appropriate for the use pattern. Examples of appropriate statements are as follows:
"Do not allow children to apply product" or "Do not allow children to play with pet collar."
D. THE HAZARDS TO HUMANS AND DOMESTIC ANIMALS STATEMENTS
1. When Required. Hazards to Humans and Domestic Animals statements are required
when any acute toxicity study results in a product classification of toxicity category I, II, or III
and/or when the dermal sensitization study result is positive. Hazards to Humans and Domestic
Animals statements may specify both mandatory actions and advisory information.
2. Required Header. The Hazards to Humans and Domestic Animals statements must
appear under the section heading "Precautionary Statements" and below the subheading "Hazard to
Humans and Domestic Animals." The Signal Word must appear before the precautionary paragraph.
[40 CFR 156.10.]
Precautionary Labeling
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3. Location and Prominence. The Hazards to Humans and Domestic Animals section
may appear on any panel. Please note, however, that these statements should not be included within
the Directions For Use section. These statements should be organized so that the routes of exposure
of most concern (severe routes of exposure) as supported by the toxicity category classification are
listed first.
4. Determining the Hazards to Humans and Domestic Animals Statements for
Fumigant Products. Refer to PR Notice 84-5, Registration Standards or Reregi strati on Eligibility
Decision Documents (REDs) suggested Hazards to Humans and Domestic Animals statements.
5. Determining the Hazards to Humans and Domestic Animals Statements for Non-
Fumigant Products. Select statements from the tables below based on the toxicity category
assigned to each study. Statements from these tables should be combined to form a concise
paragraph. Repetitious sentences should be omitted. Products in the scope of the WPS should only
use the statements in Tables 3 through 8 of this chapter. However, refer to Chapter 10 of this
manual to determine the appropriate Personal Protective Equipment. In cases where the toxicity
categories are not known, the precautionary labeling must be consistent with the signal word.
6. Related Information. Hazards to Humans and Domestic Animals statements must be
appropriate for all uses on the label. These statements must be consistent with each use pattern
listed on the label. No statement should be used that is reasonably beyond the control of the typical
applicator. Hazards to Humans and Domestic Animals statements must not require use of
specialized equipment which would not be readily available to the typical user of the product.
Table 3 - Typical Statements for Acute Oral Toxicity
Toxicity
Calcuory
Signal Word
Suilemenls
I
DANGER-POISON
Skull & Crossbones
required*
Fatal if swallowed. Wash thoroughly with soap and
water after handling and before eating, drinking,
chewing gum, or using tobacco.
II
WARNING
May be fatal if swallowed. Wash thoroughly with
soap and water after handling and before eating,
drinking, chewing gum, or using tobacco.
III
CAUTION
Harmful if swallowed. Wash thoroughly with soap
and water after handling and before eating, drinking,
chewing gum, or using tobacco.
IV
CAUTION (optional)
No statements are required. However, the registrant
may choose to use category III labeling.
For products containing 4% or more of methanol, the Agency believes that in order to mitigate
potential risk the following statement should be added to the label: "Methanol may cause
blindness."
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Table 4 - Typical Statements for Acute Dermal Toxicity
Toxicity
Cak-uory
Signal Word
Sialcmuils
I
DANGER-POISON
Skull & Crossbones
required
Fatal if absorbed through skin. Do not get in eyes, on
skin, or on clothing. Wash thoroughly with soap and
water after handling and before eating, drinking,
chewing gum, or using tobacco. Wear [specify
appropriate protective clothing]. Remove and wash
contaminated clothing before reuse.
II
WARNING
May be fatal if absorbed through skin. Do not get in
eyes, on skin, or on clothing. Wash thoroughly with
soap and water after handling and before eating,
drinking, chewing gum, or using tobacco. Wear
[specify appropriate protective clothing]. Remove and
wash contaminated clothing before reuse.
III
CAUTION
Harmful if absorbed through skin. Avoid contact
with skin, eyes or clothing. Wash thoroughly with
soap and water after handling and before eating,
drinking, chewing gum, or using tobacco. Remove
and wash contaminated clothing before reuse. Wear
[specify any appropriate protective clothing, if
appropriate].
IV
CAUTION (optional)
No statements are required. However, the registrant
may choose to use category III labeling.
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Table 5 - Typical Statements for Acute Inhalation Toxicity
Toxicity
Calcuory
Signal Word
Suilenienis
I
DANGER-POISON
Skull & Crossbones
required
Fatal if inhaled. Do not breathe (dust, vapor, or spray
mist).* Wear [specify appropriate respiratory
protection from Table 4, Chapter 10], Remove and
wash contaminated clothing before reuse.
II
WARNING
May be fatal if inhaled. Do not breathe (dust, vapor
or spray mist).* Wear [specify appropriate respiratory
protection from Table 4, Chapter 10], Remove and
wash contaminated clothing before reuse.
III
CAUTION
Harmful if inhaled. Avoid breathing (dust, vapor or
spray mist).* Remove and wash contaminated
clothing before reuse.
IV
CAUTION (optional)
No statements are required. However, the registrant
may choose to use category III labeling.
Choose the word which appropriately describes the product during use.
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Table 6 - Typical Statements for Primary Eye Irritation
Toxicity
Category
Signal Word
Statements
I
DANGER
Corrosive.* Causes irreversible eye damage. Do not get in
eyes or on clothing. Wear [specify appropriate protective
eyewear such as goggles, face shield, or safety glasses]. Wash
thoroughly with soap and water after handling and before
eating, drinking, chewing gum, or using tobacco. Remove and
wash contaminated clothing before reuse.
II
WARNING
Causes substantial but temporary eye injury. Do not get in eyes
or on clothing. Wear [specify appropriate protective eyewear
such as goggles, face shield, or safety glasses]. Wash
thoroughly with soap and water after handling and before
eating, drinking, chewing gum, or using tobacco. Remove and
wash contaminated clothing before reuse.
III
CAUTION
Causes moderate eye irritation. Avoid contact with eyes or
clothing. Wear [specify protective eyewear, if appropriate].
Wash thoroughly with soap and water after handling and before
eating, drinking, chewing gum, or using tobacco.
IV
CAUTION
(optional)
No statements are required. However, the registrant may
choose to use category III labeling.
The term "corrosive" is not required if corrosive effects were not observed during the study.
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Table 7 - Typical Statements for Primary Skin Irritation
Toxicity
Calcuoiy
Signal Word
Suilcnicnis
I
DANGER
Corrosive. Causes skin burns. Do not get in eyes, on skin, or on
clothing. Wear [specify appropriate protective clothing and
gloves]. Wash thoroughly with soap and water after handling
and before eating, drinking, chewing gum, or using tobacco.
Remove and wash contaminated clothing before reuse.
II
WARNING
Causes skin irritation. Do not get on skin or on clothing. Wear
[specify appropriate protective clothing and gloves]. Wash
thoroughly with soap and water after handling and before eating,
drinking, chewing gum, or using tobacco. Remove and wash
contaminated clothing before reuse.
III
CAUTION
Avoid contact with skin or clothing. Wash thoroughly with soap
and water after handling and before eating, drinking, chewing
gum, or using tobacco. Wear [specify protective clothing and
gloves, if appropriate].
IV
CAUTION
(optional)
No statements are required. However, the registrant may choose
to use category III labeling.
Table 8 - Typical Statements for Dermal Sensitization
Study Results
Statement
Product is a sensitizer or
is positive for
sensitization
Prolonged or frequently repeated skin contact may cause
allergic reactions in some individuals.
Product is not a sensitizer
or is negative for
sensitization
No labeling is required for this result.
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E. PERSONAL PROTECTIVE EQUIPMENT
Personal protective equipment requirements are specified for uses covered under the Worker
Protection Standard (WPS), but there are no regulatory requirements for non-WPS products,
products used by residents, or products intended only for manufacturing use. However, to protect
human health, the following guidance is offered.
1. For Non-WPS (Commercial Applicators) Uses
While there are no regulatory requirements that demand PPE for non-WPS products,
applicators are tested on their comprehension regarding what types of PPE are used and how to use
them correctly. This testing implies that PPE is expected to be worn by commercial applicators.
In order to protect human health, label reviewers are encouraged to review the toxicity data and the
potential exposures from the product's uses to determine whether PPE would be protective and
should be recommended. In cases where the reviewers determine PPE would be beneficial, the
various PPE tables in Chapter 10 provide information about which PPE is protective in specific
circumstances. However, if there is an applicable RED document which specifies PPE requirements
based on concerns specific to the active ingredient then those PPE requirements should be placed
on the label.
2. For Products used by Residents/Consumers
While there are no regulatory requirements that demand PPE for resident/consumer use
products, in order to protect human health, label reviewers are encouraged to review the toxicity data
and the product's uses to determine whether PPE would be protective and should be recommended.
In cases where the reviewers determine PPE would be beneficial, the PPE tables in Chapter 10
provide information about which PPE is protective in specific circumstances. In some cases, the
PPE indicated in these tables may need to be modified; for example, to fit the consumer's ability to
acquire it. For example, "shoes" may need to be substituted for "chemical resistant footwear" or
"safety glasses" may need to be substituted for "protective eyewear." If there is an applicable RED
document which specifies PPE requirements based on concerns specific to the active ingredient then
those PPE requirements should be placed on the label.
F. FIRST AID STATEMENTS
1. When Required. A First Aid statement is required when any acute toxicity study
result is classified as category I, II, or III. It is acceptable for the registrant to include First Aid
statements for studies that are classified as category IV.
2. Required Header. The Agency recommends that the first aid statements appear under
either of the following headings: "First Aid" or "Statements of Practical Treatment." See PRNotice
2001-1. The heading "Statements of Practical Treatment" is not recommended by the Agency for
residential/household-use products. In addition, the Agency historically has not allowed the heading
"Antidote" in conjunction with the first aid statements unless a specific antidote is recommended.
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3. Location and Prominence. First Aid statements shall appear on the front panel of the
label for all products classified as toxicity category I [40 CFR 156.68], The Agency may, however,
permit reasonable variations in the placement of the statement of First Aid as long as the reference
statement "See First Aid (or Statement of Practical Treatment) on [identify appropriate panel]"
appears on the front panel, preferably near "Poison" and the skull and crossbones. First Aid
statements for toxicity categories II and III classification may appear on any panel of the label.
However, any time First Aid statements appear other than on the front panel, a referral statement
such as "see side/back panel for first aid" should appear on the front panel in close proximity to the
Signal Word. Furthermore, First Aid statements on the side or back panel should be grouped near
the other precautionary labeling text, yet set apart or distinguishable from the other label text, for
example placed in a box below the Hazards to Humans and Domestic Animals section. First Aid
statements should be organized so that the most severe routes of exposure, as demonstrated by the
toxicity classification, are listed first.
4. Determining the First Aid Statements for Fumigant Products: Refer to PR Notice
84-5 and Registration Standards/REDs.
5. Determining the First Aid Statements for Non-Fumigant Products. Review Table
9 to determine the preferred First Aid statements for each route of exposure. Registrants should
support alternative First Aid statements with medical evaluations of the product. Approval of
alternative First Aid statements is guided by considerations such as those set out in the "Content and
Clarity" section below. The Agency has not approved the use of salt water for emesis as a first aid
technique. (See PR Notice 80-2).
a. Content and Clarity. First Aid statements must be brief, clear, simple and in
straightforward language so that the average person can easily and quickly understand the
instructions. First Aid statements should apply to all ages or when necessary, should include
distinctions between the treatments for different ages (e.g., children vs. adults). Any reasonably
competent individual should be able to perform the First Aid statements. These statements should
not include procedures which must be performed by medical personnel or require specialized
equipment. Such procedures belong under the Note to Physician heading (see section G below).
b. Acute Dermal and Primary Skin Irritation. Because both of these studies focus
on the dermal route of exposure, any first aid statements required by the results of these two studies
can be combined. Use the first aid statement required for the acute dermal toxicity study if the
results of both studies place the product in the same acute toxicity category. Use the statements for
the more severe acute toxicity category if the results of the studies would place the product in
different acute toxicity categories.
c. Eye and Skin Irritation. If the product is corrosive and is in toxicity category I or
II for eye or dermal irritation, then a first aid statement for ingestion may also be included.
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6. If the product contains an organophosphate (i.e., an organophosphorus ester that
inhibits cholinesterase) oranN-methyl carbamate (i.e., an N-m ethyl carbamic acid ester that inhibits
cholinesterase), the following phrase is recommended for the First Aid statement See PRN 200-1:
CONTAINS AN (either organophosphate or N-methyl carbamate)
THAT INHIBITS CHOLINESTERASE.
7. If the product contains zinc phosphide, the following First Aid statement is
recommended (See PRN 2000-1):
"If swallowed: Immediately call a Poison Control Center or doctor or transport the
person to the nearest hospital. DO NOT DRINK WATER. Do not administer
anything by mouth or make the person vomit unless advised to do so by a doctor."
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TABLE 9 - FIRST AID STATEMENTS
Route of Exposure
and Toxicity Category
First Aid Statement
Ingestion treatment for
acute oral toxicity
categories 1, 2, and 3
If swallowed:
-Call a poison control center or doctor immediately for treatment
advice.
-Have person sip a glass of water if able to swallow.
-Do not induce vomiting unless told to by a poison control center
or doctor.
-Do not give anything to an unconscious person.
Acute oral toxicity
category 4
Statement is not required. Registrants may use toxicity category
1-3 statements if they choose.
Skin exposure
treatment for acute
dermal toxicity, and
irritation categories 1,
2, and 3
If on skin:
-Take off contaminated clothing.
-Rinse skin immediately with plenty of water for 15-20 minutes.
-Call a poison control center or doctor for treatment advice.
Dermal and skin
irritation toxicity
category 4
Statement is not required. Registrants may use toxicity category
1-3 statements if they choose.
Inhalation treatment for
acute toxicity
categories 1, 2, and 3
If inhaled:
-Move person to fresh air.
-If person is not breathing, call 911 or an ambulance, then give
artificial respiration, preferably mouth-to-mouth if possible.
-Call a poison control center or doctor for further treatment
advice.
Inhalation toxicity
category 4
Statement is not required. Registrants may use toxicity category
1-3 statements if they choose.
Eye exposure treatment
for eye irritation
categories 1, 2, and 3
If in eyes:
-Hold eye open and rinse slowly and gently with water for 15-20
minutes. Remove contact lenses, if present, after the first 5
minutes, then continue rinsing.
-Call a poison control center or doctor for treatment advice.
Eye irritation toxicity
category 4
Statement is not required. Registrants may use toxicity category
1-3 statements if they choose.
General information to
include either near the
first aid statement or
emergency phone
number
-Have the product container or label with you when calling a
poison control center or doctor or going for treatment.
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G. NOTE TO PHYSICIANS
1. When Used. The Note to Physician is not required nor mentioned in the 40 CFR. If
the label under review is for a product which is a fumigant, refer to PR Notice 84-5 or relevant
Registration Standards or REDS for the appropriate Note to Physician. For all other products, EPA
currently uses a Note to Physician as specified in the 1984 proposed rule for the following types of
products:
a. All products that are classified as toxicity category I.
b. Products which are corrosive or classified as toxicity category I for eye or skin .
These products must include the following Note to Physician: "Probable mucosal damage may
contraindicate the use of gastric lavage."
c. Products which contain > 10% petroleum distillate should include the following
Note to Physician: "Contains petroleum distillate. Vomiting may cause aspiration pneumonia."
d. Products which produce physiological effects requiring specific antidotal or
medical treatment such as: Cholinesterase Inhibitors (e.g., carbamates and phosphorothioates, and
organophosphates); Metabolic Stimulants (e.g., dichlorphenols); Anticoagulants (e.g., warfarin).
2. Location and Prominence. The Note to Physician should be located in close
proximity to the First Aid statement, but should be clearly distinguished from it. In other words, it
should not be placed within the First Aid statement, but should appear below the last First Aid
statement.
3. Contents of Note. The Agency does not provide specific Notes to Physicians except
for toxicity category I eye and skin irritants. However, the Agency does provide the following
guidance concerning the content of Notes to Physicians. Check the label under review to make
certain that it addresses the following information:
- technical information on symptomatology;
- use of supportive treatments to maintain life functions;
- medicine that will counteract the specific physiological effects of the pesticide;
- company telephone number to specific medical personnel who can provide
specialized medical advice.
IV. LABELING OPTIONS
A. USE DILUTIONS (Aqueous Solutions only)
1. When Used. Additional Hazards to Humans and Domestic Animals and First Aid
statements which correspond with the toxicity categories associated with a product's use dilution,
may be allowed on product labels provided the conditions below are satisfactorily addressed.
Following is guidance for the submission and review of such data and for the content and placement
of associated labeling.
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2. Data Requirements. All data and draft labeling for use dilution Hazards to Humans
and Domestic Animals statements should be sent to the appropriate Product Manager with a request
for pesticide amendment. In some cases, use dilution labeling statements triggered by systemic
toxicity (acute oral, dermal or inhalation toxicity) may be supported by extrapolation from the
LD50/LC50 for the concentrate. At a minimum the following is required to even consider
extrapolating toxicity categories. This information must be submitted by the Registrant with the
extrapolation request.
a. a slope calculated from at least three, and preferably more, dose levels having
partial responses (i.e., a well characterized dose-response);
b. dose groups sufficiently large (>5 per group) to allow for the calculation of
confidence limits that fall within the defined Toxicity Category boundaries;
c. Extrapolation to a higher toxicity categories will only be applied to water
dilutions. It should also be determined that there are no other factors affecting the toxicity of the
EP (e.g., inerts that enhance the absorption of the active ingredient, promote the active ingredient's
toxicity, etc.). Other types of extrapolations will be done on a case by case basis.
d. Use dilution Hazards to Humans and Domestic Animals statements triggered by
skin or eye irritation must be supported by new or cited studies. If another registered diluted product
(such as a ready-to-use formulation) has acceptable data and is found similar to the concentrated
product after it has been diluted, those data may also be used to support revised labeling.
3. Labeling Requirements. It is not EPA's intent to allow dual sets of Hazards to
Humans and Domestic Animals statements and/or First Aid statements on the label. Rather, EPA
will allow certain modified statements to be added that are applicable to the most concentrated use
dilution only. [See 40 CFR 156.68(b)] These additional statements (triggered by the toxicity
category of the most concentrated use dilution) must be placed directly after the required statements
for the concentrate. Following are some examples (in italics) of how use dilution labeling must
appear on product labeling:
Hazards to Humans and Domestic Animals:
"Causes substantial but temporary eye injury. Do not get in eyes or on clothing.
Wear goggles or face shield. After product is diluted in accordance with the
directions for use, goggles or face shield are not required. "
First Aid:
"If on skin: Wash with plenty of soap and water. Get medical attention. If product,
diluted in accordance with the directions for use, gets on skin, medical attention is
not required."
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B. OTHER DEVIATIONS
1. Optional Hazards to Humans and Domestic Animals Statements. Registrants may
submit Hazards to Humans and Domestic Animals statements which reflect specific hazards. 40
CFR 156.10(i)(B). Such requests must be supported by data (or substantive justification), and
should be routed to label reviewers or the Chemistry and Exposure Branch (for PPE). For example,
the statements "Do not remove contact lenses, if worn. Get immediate medical attention." would
not be approved by the Agency without supporting data or rationale.
2. Toxicity Category IV Precautionary Labeling. If the product is all toxicity category
IV (non-sensitizer), precautionary labeling statements are normally not required. However, if
registrants desire to place precautionary labeling on such a product they may do so. To promote
labeling consistency it is recommended that the registrant use precautionary statements triggered by
toxicity category III. Registrants may propose alternate labeling which should be reviewed by
precautionary labeling reviewers.
3. Me-Too Deviations. If a me-too product is citing a product that has optional
statements on the label, such as IV. A. above, those statements are not required on the me-too if the
acute toxicity data results are available. Questions about the availability of the acute studies should
be referred to the precautionary labeling reviewers.
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Chapter 8 ENVIRONMENTAL HAZARDS
I. INTRODUCTION
A. The Environmental Hazards statement provides the precautionary language advising of the
potential hazards to the environment from transport, use, storage, or spill of the product. The
hazards may be to water, soil, air, beneficial insects, plants, and/or wildlife. Generally, the
information contained in this section is based upon the results of seven basic acute toxicity studies
performed on the technical grade of the active ingredient(s) in the formulation. These seven studies
are: (1) avian oral LD50 (with mallard or bobwhite quail), (2) avian dietary LC50 (mallards), (3) avian
dietary LC50 (bobwhite quail), (4) freshwater fish LC50 (rainbow trout), (5) freshwater fish LC50
(bluegill sunfish), (6) acute LCS0 freshwater invertebrates (Daphnia magna or water flea) and (7)
honeybee contact LD50 For specific data requirements see Part 158.
B. In addition, data concerning a chemical's potential to contaminate groundwater or surface
water, to drift, to adversely affect non-target plants and bees provide important information. These
studies are hydrolysis, batch equilibrium, aerobic soil metabolism, field dissipation, and the
prospective groundwater study.
C. The data generated from all of these studies support the language used for the
Environmental Hazards statements. Review of the data is performed by the Environmental Fate and
Effects Division (EFED) or other science reviewers who may also evaluate any label text proposed
by the registrant to determine what statements are required.
II. REVIEWING THE STATEMENTS
A. DOES THE PRODUCT REQUIRE AN ENVIRONMENTAL HAZARDS STATEMENT?
The label reviewer must first determine whether the use patterns on the label require any
Environmental Hazards statement. The use pattern of a pesticide helps determine the need for and
the specific text of the Environmental Hazards section. The label reviewer may conclude that all
pesticides used outdoors must have the statement. However, the reviewer should also look at the
proposed statement with a critical eye towards its applicability. Does it makes sense for the
product? For example, a granular herbicide would not generally need a statement warning of
potential spray drift problems since granular formulations are not "sprayed" and are seldom
associated with any "drift."
1. Products which are intended for use exclusively indoors may omit the Environmental
Hazards statement. Products applied to domestic animals, such as flea collars or ear tags may
generally omit the statement. However, the statement may be required for a domestic use product
such as a dog dip due to the potential for contamination of water by the use of a such a product.
Thus it is important for reviewers to carefully evaluate the use of the product to determine whether
potential risk from the transport, use, storage or disposal of the product should be mitigated by the
Environmental Hazards statement.
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2. Manufacturing use products (MPs), although used indoors to formulate other products,
require some Environmental Hazards text because MPs still are generally highly concentrated and
could pose a serious hazard if a spill occurred. A discharged statement is also required see section
F. 1. below for recommended language.
3. The Agency historically has required products labeled for use outdoors to have
Environmental Hazards statements on their labels.
4. If the reviewer determines that the use pattern triggers the need for Environmental
Hazards labeling, the proposed draft labeling must be reviewed according to the requirements
outlined in the regulations and the policy described in the remainder of this chapter.
B. STATEMENT LOCATION. The Environmental Hazards section of the label should be
located under the general heading "Precautionary Statements." It must have the heading
"Environmental Hazards" (not "Environmental Precautions," "Environmental Protections," or
anything similar). [40 CFR 156.10(h)(2)],
C. SUPPORT FOR STATEMENTS. The text of the statements is then reviewed according
to the type of action:
1. If the action represents a submission accompanied by data, the environmental science
reviewer will evaluate the environmental hazards statements and recommend any necessary label
changes as part of the data review. The label reviewer must specify all requested changes in the
response to the registrant. The necessary language must be in accordance with mandatory/advisory
guidance. See Chapter 3 and PR Notice 2000-5.
2. The environmental reviewer is responsible for reviewing data on all technical products
and may also review data associated with end-use formulations. Data requirements are governed
by FIFRA and the implementing regulation set out in Part 158. Generally speaking data are required
when an end-use formulation is likely harmful to non-target organisms (for example, micro
encapsulated insecticides which are used on crops are potentially harmful to pollinators). If the
Reregi strati on Eligibility Decision (RED) Document has been issued, it may contain appropriate
Environmental Hazards statements, but the reviewer should evaluate whether the RED specifically
addresses the use at issue and make necessary variations in the label statement. If the reviewer is
working on a me-too application for registration (where another identical or substantially similar
formulation is already registered), the Environmental Hazards statements of the similar formulation
should be compared with those in the RED. If the similar registered product label language is
consistent with the RED, the me-too Environment Hazard language should be the same as the
currently registered product. If there are no similar products, the application should be routed to
EFED or the science reviewers. Additionally, if a registrant wishes to amend the Environmental
Hazards statements, environmental reviewers may need to see the amendment application.
a. Since the cited label may have some statements that are outdated and/or missing
(required or recommended since the label was accepted), it is important to check the regulations and
the statements outlined in the rest of this chapter to make sure that both the cited label and the draft
label reflect current Agency requirements and policy.
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b. If an error is discovered in the Environmental Hazards section of the cited me-too label,
the reviewer should write a letter informing the registrant of the error(s) and request an application
for amendment be submitted within a reasonable time, such as 30 days.
D. GENERAL STATEMENTS
1. Generally, all products with directions for outdoor, terrestrial uses should have the
following statements in the Environmental Hazards section:
"For terrestrial uses: Do not apply directly to water, or to areas where surface water is
present or to intertidal areas below the mean high water mark. Do not contaminate water
when disposing of equipment washwater or rinsate."
a. These statements are preceded by "For terrestrial uses," to make it clear that the
statements do not apply to the other general use patterns — e.g., mosquito adulticides, aquatic uses
such as mosquito larvicides, aquatic herbicides, piscicides, etc., greenhouse and indoor uses.
b. Note that some Bt products do not require the above statements. Based on the fact
some Bt products are applied to terrestrial agricultural fields to control mosquitoes in periodic
standing water.
c. If a pesticide product is aerially applied to forests, the above statements should be
preceded with the phrase: "Except under the forest canopy" There are many creeks and streams
under forest canopies. The statement as written allows spraying the forest canopy, but requires spray
valves to be shut off when passing over ponds, streams, etc. not under the forest canopy.
2. For outdoor residential consumer products (except for lawn care which requires the same
statement as outdoor terrestrial uses), the statements generally required by the Agency to meet
risk/benefit concerns are as follows:
"Do not apply directly to water. Do not contaminate water when disposing of equipment
washwaters or rinsate."
a. The reviewer must keep in mind the use pattern of the product undergoing a label
review. If the product is actually intended for application to water to control algal growth, for
example the above two statements would be inappropriate. Or, if the product is a residential aerosol
spray in a can for application to wasp or hornet nests, no equipment would be used, and the
statement regarding cleaning of equipment may be omitted.
3. Products with directions for outdoor terrestrial uses requiring a fish or aquatic invertebrate
toxicity statement usually contain a statement warning of hazard from drift and or runoff. The word
drift should be omitted if the product is a "Granular" or if it is applied "in furrows"or injected into
the soil. The Agency has historically required that the following statement appear in the
Environmental Hazards section:
"Drift and runoff may be hazardous to aquatic organisms in water adj acent to treated areas."
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4. Groundwater Advisories
a. If the environmental reviewers determine that the chemical (or major degradates) has
laboratory-derived mobility (Kd less than 5) and persistence characteristics (e.g., hydrolysis half-life
at any pH greater than 30 days or aerobic soil metabolism half-life greater than 2 weeks) similar to
other pesticides found in ground water as a result of normal label uses, and no detections are
reported in ground water (for example, for a new chemical), the Agency has generally required the
following label language:
Ground Water Advisory
"This chemical has properties and characteristics associated with chemicals detected in
ground water. The use of this chemical in areas where soils are permeable, particularly
where the water table is shallow, may result in ground-water contamination."
b. If the environmental reviewers determine that the chemical (or major degradates) has
laboratory derived mobility and persistence characteristics similar to other chemicals found in
ground water as a result of normal label uses, AND:
(1) Detections are reported in ground water in a prospective ground water study or
other monitoring study conducted for registration, or other reliable monitoring data in the publicly
available literature, or
(2) Field dissipation results confirm the chemical leaches, then the Agency has
historically required the following label language:
Ground Water Advisory
"[Name of chemical] [A degradate of (name of chemical)] is known to leach through
soil into ground water under certain conditions as a result of label use. Use of this
chemical in areas where soils are permeable, particularly where the water table is
shallow, may result in ground-water contamination."
5. Surface Water Label Advisories
The Agency has historically required the following statement to be added to all household
and agricultural labels modified for the specific pesticide characteristics and targeted audience.
"This product may contaminate water through runoff. This product has a [insert phrase a. 1,
a.2, or a.3, according to the pesticide's "mean" soil partition coefficient (Kd)] for [insert
phrase b.l, b.2, or b.3, according to the pesticide's aerobic soil metabolism half-life] after
application. Poorly draining soils and soils with shallow water tables are more prone to
produce runoff that contains this product, [insert phrase c. 1 or c.2 depending on whether the
product is intended for the householder or farmer].
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a. Soil Partition Coefficient Phrases.
1. Kd less than 15 - "high potential for runoff
2. Kd between 15-300 - "a potential for runoff
3. Kd greater than 300 - "a potential for runoff
b. Aerobic Soil Metabolism Half-Life Phrases.
1. TV2 less than 8 days - 'several days after application"
2. TV2 between 8 and 30 days - "several weeks after application"
3. TV2 greater than 30 days - "several months or more after application"
c. Targeted User Community.
(1) Household Label. Avoid applying this product to ditches, swales, and drainage
ways. Runoff of this product will be reduced by avoiding applications when rainfall
is forecasted to occur within 48 hours.
(2) Agricultural Label. A level, well maintained vegetative buffer strip between
areas to which this product is applied and surface water features such as ponds,
streams, and springs will reduce the potential for contamination of water from
rainfall-runoff Runoff of this product will be reduced by avoiding applications when
rainfall is forecasted to occur within 48 hours. [For pesticides with a soil partition
coefficient of "C" add the following, " Sound erosion control practices will reduce
this product's contribution to surface water contamination]."
E. NON-TARGET ORGANISM STATEMENTS
1. The following statement has historically been required when a pesticide intended for
outdoor use contains an active ingredient which has a mammalian acute oral LD50 <100 mg/kg, an
avian acute oral LD50 <100 mg/kg, or a subacute dietary LC50 < 500 ppm1:
"This pesticide is toxic to [birds] [mammals] or [birds and mammals]."
2. The following statement has historically been required when a pesticide intended for
outdoor use contains an active ingredient with a fish acute LC50 or aquatic invertebrate (including
estuarine species such as oyster and mysid shrimp) EC50 < 1 ppm:
"This pesticide is toxic to [fish] [fish and aquatic invertebrates] [oysters/shrimp] or [fish,
aquatic invertebrates, oysters and shrimp] "
'This information will be found in submitted data, the RED document, or the Registration
Standard. It may not necessarily be available to the label reviewer, but helps you to
understand the origin of the statements.
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3. If field studies or accident history, such as the FIFRA § 6(a)(2) reports, indicate that use
of the pesticide may result in fatality to birds, fish or mammals, the following statement has
historically been required:
"This pesticide is extremely toxic to [birds], [mammals], [fish], or [birds and mammals and
fish]."
4. If a pesticide is used outdoors as a foliar application, especially to crops, and is toxic to
pollinating insects, a "Bee Hazard" warning must be included in the Environmental Hazards. 40
CFR56.10(h)(2)(ii)(E). The following table sets out the toxicity groupings and required label
statements for honey bees:
Honey Bee Toxicity Groups and Cautions
Ti»\ial\ (ii'oup
hv.v;iulkni;ii'\ Sialemeiil if 1 Alciulixl
kesidu;il Tii\iai\ is l)ispl;i\ed
hv.v;iulkni;ii'\ SiMlemeiil if
lAlciidal kesidii;il Tn\icil> is
iinl l)ispl;i\cil
I
Product contains any
active ingredient with
acute LD50 of 2
micrograms/bee or less
This product is highly toxic to bees
exposed to direct treatment or
residues on blooming crops or weeds.
Do not apply this product or allow it
to drift to blooming crops or weeds if
bees are visiting the treatment area.
This product is highly toxic to
bees exposed to direct treatment
on blooming crops or weeds.
Do not apply this product or
allow it to drift to blooming
crops or weeds while bees are
actively visiting the treatment
area.
II
Product contains any
active ingredient(s) with
acute LD50 of greater than
2 micrograms/bee but less
than 11 micrograms/bee.
This product is toxic to bees exposed
to direct treatment or residues on
blooming crops or weeds. Do not
apply this product if bees are visiting
the treatment area.
This product is toxic to bees
exposed to direct treatment. Do
not apply this product while
bees are actively visiting the
treatment area.
Ill
All others.
No bee caution required.
No bee caution required.
5. If a pesticide product is used to control aquatic weeds, the Environmental Hazards section
must normally contain the following statement:
"Treatment of aquatic weeds can result in oxygen loss from decomposition of dead weeds.
This loss can cause fish suffocation. Therefore, to minimize this hazard, treat 1/3 to V2 of
the water area in a single operation and wait at least 10 to 14 days between treatments.
Begin treatment along the shore and proceed outwards in bands to allow fish to move into
untreated areas. Consult with the State agency with primary responsibility for regulating
pesticides before applying to public waters to determine if a permit is needed."
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6. Pesticide products that include directions for mosquito control may require one of the
following statements in the Environmental Hazards section, although the aquatic toxicity of the
specific product may lead to more or less stringent statements. For example, certain bacterial
larvicides, such as some Bt products, are considered non-toxic to aquatic organisms and would not
require any statement. Some pyrethroids registered as mosquito adulticides are highly toxic to
aquatic organisms and may require stronger precautions than those listed below, tailored to the
specific products, in order to prevent water contamination. Products with aquatic toxicity concerns
between these extremes should have one of the following recommended statements:
Larvicides— "Aquatic organisms may be killed in waters where this pesticide is used.
Consult with the State agency with primary responsibility for regulating
pesticides before applying to public waters to determine if a permit is
needed."
Adulticides— "Do not apply over water, except where mosquitoes are emerging or
swarming, or to treat vegetation where mosquitoes may rest. Drift and
washoff from vegetation may be hazardous to aquatic organisms [and
wildlife] in or adjacent to treated areas. Do not contaminate water when
disposing of equipment wash waters or rinsate. Before making the first
mosquito control application in a season, consult with the State agency with
primary responsibility for regulating pesticides to determine if permits are
required."
NOTE: As this edition of the Label Review Manual is being issued, revisions to label language
concerning products for adult mosquito control are being considered by the Agency.
7. If a pesticide product is applied to irrigation water and contains an ingredient requiring
an aquatic organism toxicity statement, the Environmental Hazards section must contain the
following statement:
"Irrigation water treated with this product may be hazardous to aquatic organisms. Treated
water must either be held on the irrigated field until absorbed by the soil or not released for
(number) days."
F. MISCELLANEOUS STATEMENTS
1. For certain registered end-use products, technical grade products and other manufacturing
use products (i.e., those used to formulate other products), a "point source discharge" is a possibility
because effluent from the manufacturing plant may contain pesticides. This does not include those
products used to control roaches or other pests in the facilities, but applies to those chemicals used
in the formulation processes.
Environmental Hazards
Page 8-7
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a. The Agency recommends that the following National Pollutant Discharge Elimination
System (NPDES) statement (as outlined in PR Notice 93-10 ) should appear on such products, in
addition to any other required statements.
"Do not discharge effluent containing this product into lakes, streams, ponds, estuaries,
oceans, or other waters unless in accordance with the requirements of a National Pollutant
Discharge Elimination System (NPDES) permit and the permitting authority has been
notified in writing prior to discharge. Do not discharge effluent containing this product
to sewer systems without previously notifying the local sewage treatment plant authority.
For guidance contact your State Water Board or Regional Office of the EPA."
b. PR Notice 95-1 exempts certain end-use products [i.e., products in containers of less
than 5 gallons (liquid), less than 50 pounds (solid, dry weight) and in aerosol containers of any size]
from bearing effluent discharge statements specified by PR Notice 93-10. PR Notice 93-10 still
applies to the following kinds of pesticide products that may result in discharges to the waters of the
United States or to municipal sewer systems, including but not limited to: (A) all technical grade and
manufacturing use products; and (B) end-use products packaged in containers equal to or greater
than 5 gallons (liquid) or 50 pounds (solid, dry weight), and registered for industrial preservative,
water treatment, other industrial processing uses (such as cooling tower water systems, pulp and
paper mill water systems, secondary oil recovery injection water systems, food processing
operations, leather tanning, wood protection and textile treatment), and commercial and institutional
uses (including, but not limited to, hospitals, hotels/motels, office buildings, and prisons).
c. The exemption of certain containers from the labeling requirements of PR Notice 95-1
does not relieve a producer or user of such products from the requirements of the Clean Water Act
or state or local requirements, if applicable.
2. If a pesticide product contains directions for use in treating seed or is formulated as a
granule, pellet, or treated bait, the Agency has historically required the following Environmental
Hazards statements:
"Treated [seed], [granules], [pellets], [baits] exposed on soil surface may be
hazardous to [birds], [wildlife], [fish and aquatic invertebrates] or [birds,
other wildlife, and fish]. Cover or collect [seeds], [granules], [pellets], [baits]
spilled during loading."
3. When the label bears a reference to mixing with other products, the Agency recommends
that the registrant add a statement such as the following:
"Observe the most restrictive of the labeling limitations and precautions of all products use
in mixtures."
NOTE: Chemical specific statements, such as groundwater/surface water, spray drift/runoff, or
endangered species statements will be added to the manual as they are identified. The label reviewer
should consult with the product manager/team leader and EFED or environmental reviewer.
Environmental Hazards
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Chapter 9 PHYSICAL OR CHEMICAL HAZARDS
I. INTRODUCTION
This chapter covers the Physical or Chemical Hazards statements that are required for certain
pesticide products by the regulations of 40 CFR156.78. Such hazard statements address
flammability, explosive potential and precautions. In addition, special hazard statements are
required for certain fumigants. The reviewer should look through the regulations and through the
guidance set out in the following sections to evaluate labels..
II. PLACEMENT OF THE "PHYSICAL OR CHEMICAL HAZARDS" STATEMENT
A. Placement of the Physical or Chemical Hazards section should be immediately below the
Hazards to Humans & Domestic Animals statements and Environmental Hazards statements in the
Precautionary Statements section of the label.
B. The physical or chemical hazards section must bear the subheading "Physical or Chemical
Hazards."
III. LABELING FOR FLAMMABLE PRODUCTS
A. Precautionary statements relating to product flammability are required if the product meets
the criteria set out in the regulations and described below. Review Table 1 to determine the
appropriate flammability statements.
B. Data requirements for flammability are covered in the regulations at 40 CFR 158.190.
OPPTS Harmonized Test Guidelines Series 830, Product Properties (830-6315), covers the flash
point and flame extension of a product. The flash point is the lowest temperature at which a liquid
product containing a combustible ingredient that gives off a flammable vapor will ignite. The flame
extension test is required for aerosol products. The flame extension test is conducted by holding the
aerosol can 6 inches from a flame and discharging the product across the flame. The extension of
any flame from the flame source (typically a candle) in inches is noted and recorded. Any flame
extension more than 18 inches or any flashback of flame to the valve at any degree of valve opening
would then dictate the proper labeling of the product as either being flammable or extremely
flammable. Flashback occurs when the flame is drawn back toward the aerosol can by the stream
of propellant. This would indicate an extremely flammable product.
C. The product's flash point is shown on the Confidential Statement of Formula (CSF) and
should be expressed in degrees Fahrenheit (°F) and the equivalent in degrees Celsius (°C). For
aerosol products, the registrant is required to report the results of the flame extension test and any
positive flashbacks. This requirement does not apply to liquid products that are typically
incombustible, as well as solid products not containing combustible ingredients such as most dust
or granular formulations, pellets/tablets (baits), impregnated materials, etc. If the CSF indicates "not
applicable or N/A for flammability," you may skip this section.
Physical or Chemical Hazards
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Label Review Manual
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TABLE 1 - FLAMMABILITY STATEMENTS
Flash Point
Required Text
(A) Pressurized Containers
Flash point at or below 20°F
or if there is a flashback at
any valve opening
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.
Flash point 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 flame.
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.
All other pressurized
containers
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.
(I}) \onpressurized Containers
At or below 20°F
Above 20°F and not over
80°F
Above 80°F and not over
150°F
Extremely flammable. Keep away from fire, sparks, and
heated surfaces.
Flammable. Keep away from heat and open flame.
Combustible. Do not use or store near heat or open
flame.
[40 CFR 156.78)]
D. In order to avoid confusion with the signal word, the terms, CAUTION, WARNING, anc
DANGER (human hazard signal words) are NOT to be used with the flammability statements.
These words are only to be used as the human hazard signal word on the product. [40 CFR
156.64(b)(3)],
E. If the product is a total release fogger containing a propellent with a flash point at or below
20°F, the following label statement must be included in the "Physical or Chemical Hazard" section:
"This product contains a highly flammable ingredient. It may cause a fire or explosion
if not used properly. Follow the Directions for Use on this label very carefully."
Physical or Chemical Hazards
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In addition to this required language, a graphic symbol such as that illustrated below or an
equivalent symbol, must be displayed adjoining the "Physical or Chemical Hazard" statement. The
graphic symbol must be no smaller than twice the size of the first character of the human hazard
signal word. Also, the two phrases shown below must be presented near the graphic symbol. PR
Notice 98-6 and [40 CFR 156.78(d)(3)],
Highly Flammable Ingredient
Ingrediente Altamente Inflamable
IV. DECLARATION OF NON-FLAMMABILITY
A. NON-FLAMMABILITY CLAIM. Certain products may bear a claim of non-flammability,
with terms like "non-flammable" or "non-flammable (gas, liquid, etc.)." If the draft label has no
claim of non-flammability, skip this section. However, if the proposed draft label has such a claim,
the reviewer must check to see if the terms "Extremely Flammable" or "Flammable" do not appear
in the Physical or Chemical Hazards section of the proposed label. Obviously, if either of these
terms appear in the Physical or Chemical Hazards section, the claim of non-flammability CANNOT
be used.
B. CRITERIA FOR DECLARING NON-FLAMMABILITY
1. If the proposed label bears a claim of non-flammability, the Agency has historically
required it to meet the following criteria:
a. If a gas or mixture of gases: the product must not ignite when a lighted match is placed
against the open cylinder valve.
b. If a liquid: the product must have a flash point greater than 350°F (177°C). Refer to
the CSF for the flash point.
2. If you are unsure of whether the product meets the criteria for declaring non-flammability,
submit the label package for product chemistry review to determine the validity of the non-
flammability claim.
Physical or Chemical Hazards
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C. NON-FLAMMABILITY LABELING STATEMENT AND PLACEMENT
The phrases "non-flammable", "non-flammable gas" or "non-flammable liquid," may appear
as a sub-statement to the ingredients statement, or on a back or side panel. The phrase should not
be highlighted or emphasized such (as through use of inordinately large type size, or sharply
contrasting color, etc.) so as to constitute a misleading safety claim.
V. LABELING FOR LIQUID PRODUCTS USED NEAR ELECTRICAL EQUIPMENT
(Dielectric Breakdown Voltage)
A. If the proposed draft label is not for a liquid, skip this section. Some liquid products may
pose a shock hazard when used near electrical equipment or outlets. The dielectric breakdown
voltage is a measure of a liquid's capacity to conduct electricity and is required if the end use product
is a liquid and is to be used near electrical equipment. [See 40 CFR 158.190(a)], If the proposed
label is for a liquid product, review the criteria below:
1. Criteria for Determining the Requirement of the Shock Hazard Statement
a. The use directions permit use of the product near electrical equipment or electrical
outlets (transformers, cable TV pedestals, conduits, etc.); and
b. the data matrix does not provide a dielectric breakdown voltage; or
c. the dielectric breakdown voltage is less than 5,000 volts.
2. Shock Hazard Labeling Statement and Placement. The Agency has historically taken
the position that if the product meets the criteria above, the following statement must be shown
under the heading "Physical or Chemical Hazards."
"Do not apply this product around electrical equipment due to the possibility of
shock hazard."
(OPPTS Test Guidelines Series 830, Product Properties, #830-6321)
VI. LABELING FOR EXPLOSIVE POTENTIAL
A. WHEN REQUIRED. When data submitted in accordance with 40 CFR Part 158
demonstrate hazards of a physical or chemical nature other than flammability (such as explosive
potential), appropriate statements of hazard must be included on the label. Such statements must
address the potential explosion hazard.
B. CHEMICALS WITH POTENTIAL EXPLOSION HAZARD. Chemicals that the Agency
recommends have specific statements for potential explosion hazard include but are not limited to:
sulfur dust, carbon dust, potassium nitrate, sodium nitrate, and potassium chlorate. If the CSF
indicates that the product might require labeling for potential explosion hazard, submit the label
package for product chemistry review for a determination.
Physical or Chemical Hazards
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Current as of August 2003
VII. ADDITIONAL LABEL STATEMENTS FOR CERTAIN FUMIGANTS
For some fumigant chemicals, statements of flammability or other physical or chemical hazards
may be required. Several fumigants are highly flammable in the liquid or vapor form. The
statements of flammability listed below for the following chemicals should be located on the side
panel under the heading "Physical or Chemical Hazards." (Reference: PR Notices 84-5 and 85-6)
Sodium and Calcium Cyanides
"In the presence of moisture, highly poisonous gas (hydrogen cyanide) is formed."
VIII. WARNING STATEMENTS ABOUT MIXING CERTAIN PRODUCTS
Some products react with certain surfaces such as galvanized steel to form highly combustible
gases. Therefore, underthe Directions for Use section, some product labels prohibit mixing, storing,
or applying the product in galvanized steel or unlined steel containers. This is acceptable. However,
no human hazard signal word (Caution, Warning, or Danger) may be used with this information.
[40 CFR 156.64(b)(3)], The registrant may use "Attention," "Notice" or a similar word or phrase
to alert the user. (Refer to chapter 11, Directions for Use, for more information on this issue.)
IX. REQUIREMENT FOR USE OF FIRE RETARD ANT
Because of its combustion capability, the Agency has historically required all formulations of
sodium chlorate to include an appropriate fire retardant chemical. Refer to Chapter 5, Ingredients
Statement, for placement instructions for the required statement.
X. OTHER PHYSICAL/CHEMICAL HAZARD STATEMENTS
When data submitted in accordance with the requirements set forth in 40 CFR 158.190
demonstrate hazards of a physical or chemical nature other than flammability or explosive potential,
appropriate statements of hazard must be included on the label. Such statements may address
hazards of oxidizing or reducing capability, reactivity, or corrosivity. These decisions are made on
case-by-case basis.
Physical or Chemical Hazards
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Chapter 10 WORKER PROTECTION LABELING
I. INTRODUCTION
This chapter provides guidance for reviewing statements required for the protection of
agricultural workers and handlers. Although much of this chapter focuses on the requirements of
the Worker Protection Standard ("WPS"), it goes beyond the WPS to include protections required
for non-WPS occupational users of pesticides as well. Portions of the label that are focused on in
this chapter include the signal word, certain Precautionary Statements (Personal Protective
Equipment (PPE), Engineering Controls, User Safety Requirements, User Safety Recommendations)
and certain Directions for Use (Agricultural Use Requirements, Restricted Entry Intervals, Early
Entry PPE, Notification Statements and Non-Agricultural Use Requirements).
II. BACKGROUND
A. THE WORKER PROTECTION STANDARD. The Worker Protection Standard (WPS)
[40 CFR 170 and 40 CFR 156, Subpart K (156.200 - 212)] was published in the Federal Register
on August 21, 1992. These regulations establish standards and labeling requirements for worker
protection. Further, PR Notices 93-7, 93-11 (provides supplemental guidance to PRN 93-7) provide
Agency guidance for complying with the WPS. The correct product specific WPS labeling can be
found in the Acute Toxicity Data Evaluation Record (DER) for any given product.
B. PESTICIDE REREGISTRATION. All pesticides sold or distributed in the United States
and first registered before November 1984 must be reregistered by EPA, based on scientific studies
showing that they can be used without posing unreasonable risks to people or the environment. The
results of those reviews are published in a Reregi strati on Eligibility Decision (RED) Document. As
part of the pesticide reregi strati on process, a comprehensive worker risk assessment is performed.
The worker risk assessment is based on toxicological criteria and potential for dermal, oral or
inhalation exposure. Based on that risk assessment, worker protection labeling specific to the active
ingredient is established. When necessary to address risk to non-WPS workers, the RED Document
goes beyond the WPS to provide labeling protection for those workers not subject to the WPS.
Chemical specific worker protection labeling requirements can be found in the RED Documents.
C. EVALUATING THE RED DOCUMENT AND THE WPS. To determine the correct
worker protection labeling for a given product, the label reviewer must consider both the chemical
specific worker protection labeling defined by the RED Document and the product specific labeling
defined in the acute toxicity review and/or guidance contained in this chapter. In most cases, the
correct worker protection labeling is determined by taking the most restrictive statements from each
source.
WPS Labeling
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III. DETERMINATION OF PRODUCTS SUBJECT TO THE WORKER PROTECTION
STANDARD (WPS)
A. SCOPE OF WPS. Review this section to determine whether the label under review
involves a product that is subject to the WPS. The WPS does not apply to manufacturing use
products, or to unregistered pesticides used under an experimental use permit issued under FIFRA
section 5, or under an exemption issued under FIFRA section 18. This determination is important
because WPS products have unique labeling requirements.
B. CRITERIA. Does the product bear directions for use involving the production of an
agricultural plant [defined at 40 CFR 170.3 as any plant grown or maintained for commercial or
research purposes and includes, but not limited to, food, feed, and fiber plants; trees; turfgrass;
flowers, shrubs; ornamentals; and seedlings]. Or does the product bear labeling that could
reasonably permit such a use?
NO: The product i s not subj ect to the WP S. The requirements in thi s chapter do not apply.
YES: Does the product meet any of the exceptions listed below?
EXCEPTIONS: The WPS set out in SubpartB (40 CFR 170.102 et seq) does not apply when
any pesticide is applied on an agricultural establishment (farm, forest, nursery or greenhouse) in the
following circumstances:
~ For mosquito abatement, Mediterranean fruit fly eradication, or similar area wide public
pest control programs sponsored by governmental entities.
~ On livestock or other animals, or in or around animal premises.
~ On plants grown for other than commercial or research purposes, which may include
plants in habitations, home fruit, and vegetable gardens, and home greenhouses.
~ On plants that are in ornamental gardens, parks, golf courses, and public or private lawns
and grounds, and that are intended only for aesthetic purposes or climatic modification.
~ By injection directly into agricultural plants. Direct injection does not include "hack and
squirt," "frill and spray," "chemigation," soil-incorporation, or soil injection.
~ In a manner not directly related to the production of agricultural plants, including, but not
limited to, structural pest control, control of vegetation along rights-of-way and in other non-crop
areas, and pasture and rangeland use. Note if the registrant wants to include directions for cutting
hay in pastures or rangelands then the product must bear WPS requirements.
~ For control of vertebrate pests.
~ As attractants or repellents in traps.
WPS Labeling
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~ Post harvest treatments on the harvested portions of agricultural plants or harvested
timbers.
~ For research uses of unregistered pesticides.
NO: The product IS subject to the WPS. Keep reading.
YES: The product is NOT subject to the WPS. The requirements in this chapter do not
apply.
1. Remember, in some cases it is not clear whether or not a product is "in-scope" of the
WPS. If the intention is to remove the product from the scope of the WPS, language should be used
that limits where this product can be applied, rather than who may apply it. This can be done by
using exclusionary statements such as the following:
"Not for use on turf being grown for sale or other commercial use as sod, or for
commercial seed production, or for research purposes."
or
"For use only on home lawns."
2. For further details, see PR Notice 93-11, Supplement F.
IV. SIGNAL WORD
Products subject to the WPS that are classified as toxicity category I or II must also bear the
corresponding Spanish signal word and the Spanish statement provided below. The Spanish signal
word and statement below must appear in close proximity to the English signal word. The Spanish
signal word for toxicity category I is "PELIGRO" and the Spanish signal word for toxicity category
II is "AVISO." The statement that must appear on toxicity category I and II WPS products is as
follows:
"Si usted no entiende la etiqueta, busque a alguien para que se la explique a usted en
detalle. (If you do not understand the label, find someone to explain it to you in
detail.)"
V. SPLIT LABELING FOR WPS AND OCCUPATIONAL USE PRODUCTS
A. If a registered product contains uses that are both subject to WPS and not subject to WPS,
the registrant should be encouraged to have separate registrations for each use type. However, the
registrant is allowed to register the product with both use types on one label and /or choose to market
the product with two sub-labels (under one registration) featuring only one of the use types on each
sub-label. The registrant may market the product under two distinctly different product labels, using
additional brand names for the WPS labeling and non-WPS labeling. If the registrant chooses to
market the product with both WPS and non-WPS uses, a Non-Agricultural Use Requirements box
must be used to contain all non-WPS worker related restrictions. In either case, the registrant must
submit a master label that clearly distinguishes between the two separate sub-labels. However, it
WPS Labeling
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Label Review Manual
Current as of August 2003
is not permissible to provide the WPS labeling merely as a supplemental label to a non-WPS
product.
B. Many pesticide products also contain residential consumer uses along with WPS and non-
WPS occupational uses. Because the personal protective equipment and other worker protection
statements may be significantly different for occupational and residential consumer products, the
registrant should be strongly encouraged to submit separate registrations with one containing the
WPS and Non-WPS Occupational uses, and the other containing the residential consumer uses.
VI. PRECAUTIONARY STATEMENTS
There are four types of worker protection statements that appear in the Precautionary
Statements of a label. They are as follows: A) Handler Personal Protective Equipment (PPE); B)
User Safety Requirements; C) Engineering Controls; and D) User Safety Recommendations. These
statements may be required by the WPS on in-scope products and also on non-WPS occupational
products if required by a RED Document. The reviewer should also refer to Chapter 7 for
additional, non-WPS, information on determining the correct toxicity category and other appropriate
precautionary language.
A. HANDLER PERSONAL PROTECTIVE EQUIPMENT (PPE)
The correct handler PPE is determined by comparing the product specific handler PPE
specified in the acute toxicity review for a product with the chemical specific handler PPE
requirements specified in the RED Document. In most cases, the reviewer uses a combination
of the most protective statements given in the RED Document and the Acute Toxicity Review to
determine the correct handler PPE labeling. The correct product specific handler PPE can be derived
from the Acute Toxicity Review for a given product or refer to sections 1 through 4 below to
determine the correct product specific PPE. Once the correct product specific Handler PPE has been
determined, the reviewer should compare this labeling with worker protection labeling required by
the RED Document and use the table in this section to select the most protective PPE.
1. Identifying the Correct Product Specific Handler Protective Clothing. Once the
correct toxicity category has been established, the product specific handler PPE can be identified.
Reviewers may obtain the correct product specific handler protective clothing from the Acute
Toxicity Review. Table 1 below shows how the correct product specific handler protective clothing
is derived in the Acute Toxicity Review based on the toxicity category for a given product.
WPS Labeling
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Label Review Manual Current as of August 2003
TABLE 1 - HANDLER PPE FOR WPS PRODUCTS
Toxicity Category h\ Route of l-\posuiv of 1 jid-l se
Rome of
Product
1 .\ posn IV
I
II
III
IV
DANGER
WARNING
CAUTION
CAUTION
Dermal
Coveralls
Coveralls worn
Long-
Long-
Toxicity
worn over
over short-
sleeved
sleeved
or Skin
long-
sleeved shirt
shirt and
shirt and
Irritation
sleeved
and short pants
long pants
long pants
Potential1
shirt and
long pants
Socks
Socks
Socks
Socks
Chemical-
Shoes
Shoes
Chemical-
resistant
resistant
footwear
footwear
Chemical-
No
Chemical-
Chemical-
resistant
minimum4
resistant
resistant
Gloves2
Gloves2
Gloves2
Inhalation
Respiratory
Respiratory
No
No
Toxicity
protection
protection
minimum4
minimum4
device3
device3
Eye
Protective
Protective
No
No
Irritation
eyewear5
eyewear5
minimum4
minimum4
Potential
1 If dermal toxicity and skin irritation toxicity categories are different, PPE shall be determined by
the more severe toxicity category of the two. If dermal toxicity or skin irritation is category I or II,
refer to Section 3 below to determine if additional PPE is required beyond that specified in Table
2 Refer to Section 3, Table 3 to determine the specific type of chemical-resistant glove.
3 Refer to Section 4 to determine the specific type of respiratory protection.
4 Although no minimum PPE is required for these toxicity categories and routes of exposure, the
Agency may require PPE on a product-specific basis.
5 "Protective eyewear" is to be used instead of "goggles" and/or "face shield" and/or "shielded
safety glasses" and similar terms to describe eye protection.
WPS Labeling
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2. Identifying Additional Product Specific Handler Protective Clothing (Apron and
Headgear) Additional PPE is required for products that are classified as toxicity category I or II for
acute dermal toxicity or skin irritation. If the label under review does not involve a category I or II
classification for either of these studies, skip this section. If the label under review does involve a
category I or II classification for either the acute dermal toxicity or skin irritation, review Table 2
below to determine the additional product specific PPE.
TABLE 2 - ADDITIONAL DERMAL TOXICITY AND/OR SKIN IRRITATION PPE FOR
TOXICITY CATEGORY I OR II
Conditions Requiring Additional PPE and
Labeling
Required PPE and Labeling
All products that are not ready to use and do
not require a chemical resistant suit must bear
the corresponding statement:
"When mixing and loading wear a chemical
resistant apron."
All products labeled for application
procedures that might involve overhead
exposure must bear the corresponding
statement:
"For overhead exposure wear chemical-
resistant headgear."
All products labeled for use of equipment
other than the product container to mix, load
or apply the product must bear the
corresponding statement:
"When cleaning equipment wear a chemical-
resistant apron."
3. Product Specific Glove Selection for Handlers. Chemical-resistant gloves are required
for all products classified as toxicity category I, II, or III for acute dermal toxicity or primary skin
irritation. Review the types of chemical-resistant gloves below, and determine if the label lists the
appropriate glove type based on the product formulation. The registrant can specify a chemical-
resistant glove type other than those specified in Table 3 if information is available that indicates
that another glove type is more appropriate or provides greater protection. The registrant must
verify why the alternative glove should be used. The label must indicate the specific type of
chemical-resistant glove(s) (such as nitrile, butyl, etc. for the appropriate category of solvent). See
the solvent li st in PR Notice 93 -7, pp. 13 -15. For those solvents not li sted contact the Health Effects
Division's Chemistry and Exposure Branch (CEB-I ). Listed below are the standard glove types
required by the WPS.
a. Solid Formulations: applied as solids or formulations containing only water as the
solvent or contain solvents other than water at less than 5%, the glove statement shall specify
"chemical-resistant" gloves. (Reference: Supplement III, Main Labeling Guidance, Page ll,ofPR
Notice 93-7.
b. Aqueous-Based Formulations: applied as formulated or diluted solely with water for
application, the glove statement shall specify "chemical-resistant" gloves.
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c. Other Liquid Formulations which are formulated or diluted with liquids other than
water: (constitutes more than 5% of the end-use product), the glove statement shall specify
"chemical-resistant (such as nitrile or butyl) gloves."
d. Gaseous Formulations or Formulations applied as Gases: may retain any existing glove
statement established before 10/20/92 including any glove prohibition statement. If no glove
statement or glove prohibition currently exists on the label, then the glove statement shall be
"chemical-resistant (such as nitrile or butyl) gloves."
TABLE 3 - EPA CHEMICAL RESISTANCE CATEGORY SELECTION CHART
(For use when PPE section on pesticide label lists a chemical resistance category)
SELECTION
CATEGORY
LISTED ON
PESTICIDE
LABEL
TYPE OF PERSONAL PROTECTIVE MATERIAL
Barrier
Laminate
Butyl
Rubber
k 14
mils
Nitrile
Rubber
^ 14 mils
Neo-
prene
Rubber
k 14 mils
Natural
Rubber*
k 14 mils
Poly-
ethylene
Polyvinyl
Chloride
(PVC)
s 14 mils
Viton
k 14
mils
A
(dry and
water-based
formulations)
NA
NA
NA
NA
high
NA
NA
NA
B
high
high
slight
slight
none
slight
slight
slight
C
high
high
high
high
moderate
moderate
high
high
D
high
high
moderate
moderate
none
none
none
slight
E
high
slight
high
high
slight
none
moderate
high
F
high
high
high
moderate
slight
none
slight
high
G
high
slight
slight
slight
none
none
none
high
H
high
slight
slight
slight
none
none
none
high
*includes natural rubber blends and laminates
HIGH: Highly chemical-resistant. Clean or replace PPE at end of each day's work period. Rinse off pesticides at rest breaks.
MODERATE: Moderately chemical-resistant. Clean or replace PPE within an hour or two of contact.
SLIGHT: Slightly chemical-resistant. Clean or replace PPE within ten minutes of contact.
NONE: No chemical-resistance. Do not wear this type of material as PPE when contact is possible.
NA: Not Applicable. Provides high resistance but exceeds level of protection required for these formulations.
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4. Product Specific Respiratory Protection Device (RPD) Selection for Handlers:
RPD(s) are required for all products classified as toxicity category I or II for acute inhalation.
Review the RPD types in Table 4 and determine if the label lists the appropriate type based on the
product description and toxicity category. If the registrant has submitted information showing that
a more protective RPD should be selected, allow the registrant to retain that RPD requirement on
the label under review. Information that could support an alternate RPD could be the submission
of the product vapor pressure data indicating that the RPD specified in Table 4 would not provide
adequate protection or could pose an increased risk to the user.
a. In June 1995, the National Institute for Occupational Safety and Health (NIOSH)
revised the certification criteria and definitions for nonpowered, air-purifying particulate respirators.
42 CFR Part 84 replaced the outdated certification standards in 30 CFR Part 11 regulations. The
new Part 84 regulation creates a total of nine classes of particulate filters; these classes apply only
to nonpowered, air-purifying, particulate filter respirators. Since NIOSH allowed manufacturers of
respirators to continue selling and shipping Part 11 particulate filters as NIOSH-certified until July
10, 1998, changes in label language were phased in as described below.
b. New and Old Respirator Language Schedule
(1) April 1, 2000: New language must be present on all labels.
(2) Between April 1, 2000 and March 31, 2001: registrants must include both old
language and new language on labels.
(3) After April 1, 2001: registrants may begin removing old language from labels.
(4) After April 1,2004: Registrants must have new language and old language must
be gone.
c. Oil definition. NIOSH defines oil as a high boiling-point, liquid hydrocarbon that will
accumulate on a respirator's particulate filter with minimal evaporation. This includes any of a large
class of substances which are viscous, combustible, liquid at ordinary temperatures, and soluble in
ether or alcohol but not in water. Some examples of oil-type products or products that contain oil
are: mineral oils (e.g., petroleum/hydrocarbons lubricating oils), as well as certain adjuvants such
as crop oils and surfactants added when a pesticide product is mixed with water or with other
pesticides in tank mixes. If an oil is present at any level in the pesticide itself or in the mixture of
pesticide with water, solvent, fertilizer, adjuvants, etc. added to the crop, and if a respirator is
required (i.e. if the product is in toxicity category I or II for inhalation toxicity), then only an R- or
P-series respirator may be used; an N-series respirator may only be used when there is no oil
involved.
d. In determining whether a pesticide product label should require the use of non-oil
resistant N-series, oil-resistant R-series, or oil-proof P-series respirators the reviewer should first
examine the CSF for the presence of oil compounds in the product formulation at any concentration.
Generally, N-series are only used for non-oil based aerosols. R-series may be used for oil based
aerosols with a time limitation of 8 hours, and P-series for periods of time longer than 8 hours with
considerations of resistance, soiling, or damage. The reviewer should then examine the Directions
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for Use section of the label for instructions calling for the addition of crop oils, surfactants and other
organic substances that may be oils as defined by NIOSH. If the reviewer has any question whether
a substance listed in either the CSF or the Directions for Use is actually an oil, this question should
be referred to the Chemistry group of the Registration Division's Technical Review Branch or a
Chemist in the appropriate Division.
TABLE 4 - NEW AND OLD RESPIRATOR LANGUAGE
Pesticide Type
If Old Language
New Language (per PR
Said:
Notice 98-9) must say:
Gases Applied
"...a respirator with
Pesticide Mixtures with Oil:
Outdoors: Products
an organic-vapor-
"...respirator with an organic-
that are formulated
removing cartridge
vapor removing cartridge
or applied as a gas
with a prefilter
with a prefilter approved for
(space and soil
approved for
pesticides (MSHA/NIOSH
fumigants) and
pesticides
approval number prefix TC-
that may be
(MSHA/NIOSH
23C), or a canister approved
applied outdoors
approval number
for pesticides
must bear labeling
prefix TC-23C) OR
(MSHA/NIOSH approval
specifying the
a canister approved
number prefix TC-14G), or a
following RPD
for pesticides
NIOSH approved respirator
requirements and
(MSHA/NIOSH
with an organic vapor (OV)
statement:
approval number
cartridge or canister with any
prefix TC-14G)".
R, P or HE prefilter."
Pesticide Mixtures without Oil:
"...respirator with an organic-
vapor removing cartridge
with a prefilter approved for
pesticides (MSHA/NIOSH
approval number prefix TC-
23C), or a canister approved
for pesticides
(MSHA/NIOSH approval
number prefix TC-14G), or a
NIOSH approved respirator
with an organic vapor (OV)
cartridge or canister with any
N, R, P or HE prefilter."
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TABLE 4 - NEW AND OLD RESPIRATOR LANGUAGE
Pesticide Type
If Old Language
New Language (per PR
Said:
Notice 98-9) must say:
Gaseous Products
"...For handling
Pesticide Mixtures with Oil:
Used in Enclosed
activities in
language did not change except that
Areas: Products
enclosed areas, use
the references to MSHA should be
that are formulated
either a supplied-air
deleted.
or applied as a gas
respirator with
(space and soil
MSHA/NIOSH
Pesticide Mixtures without Oil -
fumigants) and
approval number
language did not change except that
that may be used
prefix TC-19C, OR
the references to MSHA should be
in greenhouses or
a self-contained
deleted.
other enclosed
breathing apparatus
areas must bear
(SCBA) with
labeling
MSHA/NIOSH
specifying the
approval number
following RPD
TC-13F."
requirements and
statement:
The designations
for the TC-19C and
TC-13F respirators
did not change with
the latest NIOSH
regulations.
Solid Products:
"...dust/mist
Pesticide Mixtures with Oil:
Products that are
filtering respirator
"...dust/mist filtering
formulated and
(MSHA/NIOSH
respirator (MSHA/NIOSH
applied as solids.
approval number
approval number prefix TC-
prefix TC-21C)."
21C), or a NIOSH approved
respirator with any R, P, or
HE filter.
Pesticide Mixtures without Oil:
"...dust/mist filtering
respirator (MSHA/NIOSH
approval number prefix TC-
21C), or a NIOSH approved
respirator with any N, R, P or
HE filter."
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TABLE 4 - NEW AND OLD RESPIRATOR LANGUAGE
Pesticide Type
If Old Language
New Language (per PR
Said:
Notice 98-9) must say:
Liquid Products in
"...a respirator with
Pesticide Mixtures with Oil: "...
Toxicity Category I:
an organic-vapor-
respirator with an organic-
Products that are
removing cartridge
vapor removing cartridge
formulated and
with a prefilter
with a prefilter approved for
applied as liquids
approved for
pesticides (MSHA/NIOSH
must bear labeling
pesticides
approval number prefix TC-
specifying the
(MSHA/NIOSH
23C), or a canister approved
following RPD
approval number
for pesticides
requirements and
prefix TC-23C),
(MSHA/NIOSH approval
statement:
number prefix TC-14G), or a
OR a canister
NIOSH approved respirator
approved for
with an organic vapor (OV)
pesticides
cartridge or canister with any
(MSHA/NIOSH
R, P or HE prefilter."
approval number
prefix TC-14G)".
Pesticide Mixtures without Oil:
"...respirator with an organic-
vapor removing cartridge
with a prefilter approved for
pesticides (MSHA/NIOSH
approval number prefix TC-
23C), or a canister approved
for pesticides
(MSHA/NIOSH approval
number prefix TC-14G), or a
NIOSH approved respirator
with an organic vapor (OV)
cartridge or canister with any
N, R, P or HE prefilter."
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TABLE 4 - NEW AND OLD RESPIRATOR LANGUAGE
Pesticide Type
If Old Language
New Language (per PR
Said:
Notice 98-9) must say:
Liquid Products in
"For handling
Pesticide Mixtures with Oil:
Toxicity Category II:
activities during
"...respirator with an organic-
Products that are
[insert applicable
vapor removing cartridge
formulated or
terms based on
with a prefilter approved for
applied as liquids:
directions for use,
pesticides (MSHA/NIOSH
such as: air blast,
approval number prefix TC-
mist blower,
23C), or a canister approved
pressure greater
for pesticides
than 40 p.s.i. with
(MSHA/NIOSH approval
fine droplets,
number prefix TC-14G), or a
smoke, mist, fog,
NIOSH approved respirator
aerosol or direct
with an organic vapor (OV)
overhead], use
cartridge or canister with any
either a respirator
R, P or HE prefilter."
with an organic
vapor-removing
Pesticide Mixtures without Oil:
cartridge with a
"...respirator with an organic-
prefilter approved
vapor removing cartridge
for pesticides
with a prefilter approved for
(MSHA/NIOSH
pesticides (MSHA/NIOSH
approval number
approval number prefix TC-
prefix TC-23C), OR
23C), or a canister approved
a canister approved
for pesticides
for pesticides
(MSHA/NIOSH approval
(MSHA/NIOSH
number prefix TC-14G), or a
approval number
NIOSH approved respirator
prefix 14G). For all
with an organic vapor (OV)
other exposures, use
cartridge or canister with any
a dust/mist filtering
N, R, P or HE prefilter."
respirator
(MSHA/NIOSH
approval number
prefix TC-21C)."
e. Respirator types for which label language changes are not required at this time.
(1) powered air purifying respirator equipped with a high efficiency particulate air
(HEPA) filter (MSHA/NIOSH approval number prefix TC-21C).
(2) powered air purifying respirator equipped with an organic-vapor (OV) removing
cartridge plus a high efficiency (HE) filter (MSHA/NIOSH approval number prefix TC-23C).
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(3) powered air purifying canister-type respirator (gas-mask) equipped with an
organic vapor canister that uses HE filters (MSHA/NIOSH approval number prefix TC-14G).
f. In reviewing the NIOSH certification changes, EPA has concluded that all 42 CFR 84
(Part 84) respirators meet or exceed all 30 CFR 11 (Part 11) requirements and that a respirator
certified under Part 84 is an acceptable substitute for a respirator certified under Part 11.
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TABLE 5 - Oil Resistance & Efficiency of Filters
Filter
N-series particulate
R-series particulate
P-series filters
Efficiency
filters
Not resistant to oil.
filters
Oil-resistant.
Oil-proof.
95%, 99%,
N95/ N99/ N100
R95/ R99/ R100
P95/ P99/ PI00
and
Not resistant to oil.
Oil-resistant.
Oil-proof
99.97%
May be used for solid &
May be used for solid &
May be used for solid
liquid particulate
liquid particulate hazards.
& liquid particulate
hazards.
Time limitations: The R-
hazards.
Time limitations: Use
series filters should be
Time limitations:
and reuse of N-series
used only for a single shift
Use and reuse of
filters would be subject
(or for 8 hours of
the P-series
only to considerations
continuous or intermittent
filters would be
of hygiene, damage and
use) when oil is present.
subject to the
increased breathing
(See manufacturer's
manufacturer's
resistance. (See
recommendations, and the
recommendati on
manufacturer's
Use Limitation section
Repeated
recommendations, and
within PR Notice 98-9 for
exposures may
the Use Limitation
guidance on determining
degrade the
section within PR
whether a respirator filter
filter below its
Notice 98-9 for
can still function after a
rated efficiency.
guidance on
particular exposure).
(See
determining whether a
manufacturer's
respirator filter can still
recommendati on
function after a
and the Use
particular exposure).
Limitation
section within
PR Notice 98-9
for guidance on
determining
whether a
respirator filter
can still function
after a particular
exposure).
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5. Compare Product Specific PPE with PPE Required by the RED Document. After
completing steps 1 through 4 and identifying the handler PPE based on the product specific acute
toxicity data, the reviewer must now consider the PPE required by the RED Document, if one has
been published. A combination of the most protective PPE specified in the Acute Toxicity Review
(or derived from steps 1 through 4 above) and the RED Document must be used to determine the
appropriate product labeling. For guidance on which PPE is considered more protective, consult
Table 6.
Note: All end-use occupational use products (WPS or non-WPS) must have the minimum baseline
Handler PPE of long-sleeved shirt, long pants and socks and shoes.
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Table 6 - Guide to Selecting the Most Protective Handler PPK
Level of Protection
Type of PPE
Minimum
Required
Next Highest Level
of Protection
Next Highest
Level of
Protection
Highest
Level of
Protection
Protective Clothing
Long-sleeved shirt
and long pants
Coveralls over short-
sleeved shirt and short
pants
Coveralls over long-
sleeved shirt and long
pants
Chemical
Resistant Suit
Protective Footwear
Socks and Shoes
Chemical -resistant
footwear
Chemical-resistant
boots
NA
Gloves
None
Chemical-resistant
gloves
NA
NA
Protective Headwear
None
Chemical-resistant
headgear
NA
NA
Chemical resistant
Apron
None
Chemical-resistant
apron worn over long-
sleeved shirt and long
pants
Chemical-resistant
apron worn over
coveralls over long-
sleeved shirt and long
pants
NA
Respiratory
Protection Device
None
Dust/mist filtering
respirator
Organic Vapor (OV)
removing respirator
Air
Supplying
Respirator
6. Required Location for Handler PPE. Handler PPE statements for applicators and
other handlers must appear in the "PRECAUTIONARY STATEMENTS" section of the labeling.
The preferred location is directly below the Hazards to Humans and Domestic Animals Statements.
7. States may require the use of additional WPS PPE. The Agency will approve
additional state-required language if it is clear that it applies only in that state.
B. PESTICIDE USER SAFETY REQUIREMENTS
1. Statements for Contaminated Personal Protective Equipment
a. All occupational use products must bear the following statements:
"Follow the manufacturer's instructions for cleaning/maintaining PPE. If no such
instructions for washables, use detergent and hot water. Keep and wash PPE separately
from other laundry."
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b. If the product is a concentrate (diluted before use, or is an ultra-low-volume or low-
volume concentrate, or contains more than 50% active ingredient) and is in Toxicity Category I or
II, its label must include the following statement before the previous statement:
"Discard clothing and other absorbent materials that have been drenched or heavily
contaminated with this product's concentrate. Do not reuse them."
Note: The RED Document may also require the above statement.
2. User Safety Requirements must appear in the "PRECAUTIONARY STATEMENTS"
section of the labeling. The preferred location is directly below the Personal Protective Equipment.
NOTE: If a RED has not been done "User Safety Requirements" identified as such may not exist.
C. ENGINEERING CONTROL STATEMENTS
1. PPE for Engineering Control Systems. Engineering Controls may be required by the
RED Document or by the Acute Toxicity profile of a given product.
a. Engineering Controls for Toxicity I and II Products. Unless it is supplemented or
superseded by the RED Document, if product is Toxicity Category I or II for either acute dermal
toxicity or skin irritation potential, or if either of these data are not available, use the end-use product
signal word as a surrogate, then the following statements shall appear on the label.
"When handlers use closed systems, enclosed cabs, or aircraft in a manner that meets the
requirements listed in the Worker Protection Standard (WPS) for agricultural pesticides
(40 CFR 170.240(d)(4-6), the handler PPE requirements may be reduced or modified as
specified in the WPS."
(For products packaged in water-soluble packages)
"Water-soluble packets, when used correctly, qualify as a closed loading system under the
WPS. Handlers handling this product while it is enclosed in intact water-soluble packets
may elect to wear reduced PPE of long-sleeved shirt, long pants, shoes, socks, a chemical-
resistant apron, and chemical-resistant gloves."
"IMPORTANT: When reduced PPE is worn because a closed system is being used,
handlers must be provided all PPE specified above for "applicators and other handlers"
and have such PPE immediately available for use in an emergency, such as a spill or
equipment break-down."
b. Engineering Controls for Toxicity III and IV Products. Unless it is supplemented or
superseded by the RED Document, if the product is Toxicity Category III or IV for acute dermal
toxicity and skin irritation potential, or if either of these data are not available, and signal word is
CAUTION, then the following statements must appear on the label.
"When handlers use closed systems, enclosed cabs, or aircraft in a manner that meets the
requirements listed in the Worker Protection Standard (WPS) for agricultural pesticides
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(40 CFR 170.240(d)(4-6), the handler PPE requirements may be reduced or modified as
specified in the WPS."
{For products packaged in water soluble packages)
"Water-soluble packets, when used correctly qualify as a closed loading system under the
WPS. Handlers handling this product while it is enclosed in intact water-soluble packets
may elect to wear reduced PPE of long-sleeved shirt, long pants, shoes, and socks instead
of listed PPE."
"IMPORTANT: When reduced PPE is worn because a closed system is being used,
handlers must be provided all PPE specified above for "applicators and other handlers"
and have such PPE immediately available for use in an emergency, such as a spill or
equipment break-down."
2. Engineering Controls must appear in the "PRECAUTIONARY STATEMENTS" section
of the labeling.
D. USER SAFETY RECOMMENDATIONS
1. When Required. If the product falls within the scope of WPS, then a User Safety
Recommendations box, as indicated in PR Notice 93-7, Supplement Three, must also appear in a
separate box on the label containing appropriate user safety information. Many RED Documents
also require User Safety Recommendations for Non-WPS occupational use products. Although the
registrant may include any appropriate user safety recommendations on their label, below are some
typical statements required by the RED Documents or found on many products.
2. Example of a User Safety Recommendations Box
"I ser Safety Recommendations"
"I sers should wash hands before eating. drinking, chewing gum. using lohacco. or
using (lie toilet."
"I sers should remove clothing/PPK immediately if pesticide gels inside. 'Mien wash
thoroughly and put on clean clothing."
"I sers should remove PPK immediately after handling this product. \\ ash the outside
of gloves before removing. As soon as possible, w ash thoroughly and change into clean
clothing."
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VII. DIRECTIONS FOR USE
A. PRODUCTS SUBJECT TO THE WPS. For products subject to the WPS, there are four
types of worker protection statements that appear in the Directions for Use of a label. They are as
follows: 1) General Statements; 2) Brief Agricultural Use Requirements Referral Statement; 3)
Agricultural Use Requirements; and 4) Non-Agricultural Use Requirements.
1. General Statements. The following statements must appear on all WPS labels near the
beginning of the Direction for Use section of the labeling under the heading Agricultural Use
Requirements. See the sample at the end of this chapter.
a. "Do not apply this product in a way that will contact workers or other persons, either
directly or through drift. Only protected handlers maybe in the area during application." (For wide-
area treatments, see section 3c below under Directions for Use)
b. "For any requirements specific to your State or Tribe, consult the State or Tribal
agency responsible for pesticide regulation."
2. Brief Agricultural Use Requirements Referral Statement
"Agricultural Use Requirements
Use this product only in accordance with its labeling and with the Worker
Protection Standard, 40 CFR Part 170. Refer to supplemental labeling under
"AGRICULTURAL USE REQUIREMENTS" in the DIRECTIONS FORUSE
section for information about this standard."
a. This statement should be used if you put the Agricultural Use Requirements Box in
Supplemental Labeling.
b. This statement must appear on the product label near the statement referring users to
the supplemental labeling. This statement must be IN A BOX under the heading
"AGRICULTURAL USE REQUIREMENTS."
3. Agricultural Use Requirements Box Statements. The following statements must also
appear on all WPS labels. These statements must appear after the heading "Directions for Use" and
IN the AGRICULTURAL USE REQUIREMENTS box. (See example AGRICULTURAL USE
REQUIREMENTS box at the end of this chapter.)
a. "Use this product only in accordance with its labeling and with the Worker Protection
Standard, 40 CFR Part 170."
b. "This standard contains requirements for the protection of agricultural workers on
farms, forests, nurseries, and greenhouses, and handlers of agricultural pesticides. It contains
requirements for training, decontamination, notification, and emergency assistance. It also contains
specific instructions and exceptions pertaining to the statements on the label about personal
protective equipment, restricted-entry interval, and notification to workers (as applicable)."
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c. Do the use directions of the end-use product permit area wide treatment in residential
or public areas through fog, aerial, or other broadcast application where contact with workers or
other persons, either directly or through drift cannot reasonably be avoided? Examples: applications
for control of mosquitoes, gypsy moths, or Mediterranean fruit flies. If the product permits those
types of area wide treatment, then the statement, "Do not apply this product in a way that will
contact workers or other persons, either directly or through drift. Only protected handlers may be
in the area during application," should appear IN the "AGRICULTURAL USE REQUIREMENTS"
Box.
d. Restricted Entry Statements. All WPS products must have a Restricted Entry Interval
(REI). An REI is the time period immediately following a pesticide application during which entry
into the treated area is restricted. REIs are set by Supplement Three-A of PRNotice 93-7, the RED
Document or by using the guidelines listed below. If the REI established by the RED Document
is different from the guidance below, the REI established by the RED must be required on the label.
Some labels may have several different REIs for different crops. The REI must appear in the
following format:
"Do not enter or allow worker entry into treated areas during the restricted-entry
interval (REI) (include single REI here, see below for multiple REIs)."
* Single REI: If a product has only one REI, then the REI shall appear as a continuation
of the above required sentence in one of the following formats: "of X hours"; "of X days"
or "until the acceptable exposure level of X ppm or mg/m3 is reached."
* Multiple REI(s): If different REI's exist for certain crops or uses, then the REI must
appear in the directions for use for that crop or use. The REI must be immediately
preceded or followed by the word "Restricted Entry Interval" or the letters "REI."
* 72 hr REI for organophosphorous ester in arid areas: If the active ingredient is an
organophosphorous ester that may be applied outdoors in an area where the average
annual rainfall for the application site is less than 25 inches per year, the following
statement shall be added to the restricted-entry statement: 72 hours in outdoor areas where
average annual rainfall is less than 25 inches a year.
e. Early Entry PPE
(1) All products subject to the WPS must bear the following statements for workers
who reenter the treated area prior to the expiration of the restricted entry interval:
"For early entry into treated areas that is permitted under the Worker Protection
Standard and that involves contact with anything that has been treated, such as
plants, soil, or water, wear:" (Insert all Early Entry PPE specified by the RED
document. If there is no RED document follow the guidelines below to select the
correct early entry PPE)
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(2) If a RED document has not yet been issued for a chemical, consider the following
when selecting the correct early entry PPE: a) start with the Handler PPE; b) omit any respiratory
protective devices; c) if the handler body clothing requirement is a long-sleeved shirt and long pants,
then the early-entry worker requirement shall be "coveralls"; and d) if there is no handler
requirement for gloves, then the early-entry requirement shall be "chemical resistant gloves (made
of any waterproof material)."
f. Notification-to-Workers Statements. Notification to workers statement is required if
the product meets the criteria below:
(1) Fumigants: Fumigants that are registered for use in greenhouses or whose
labeling allows use in greenhouses must bear the following statement:
"For greenhouse applications, notify workers of the application by warning
them orally and by posting warning signs outside all entrances to the
greenhouse."
(2) All Other Products: Products which contain any active ingredient classified as
toxicity category I based either on acute dermal toxicity data, skin irritation data, or the criteria
below shall bear the following notification statement:
"Notify workers of the application by warning them orally and by posting warning
signs at entrances to treated areas."
(a) To identify the toxicity category follow the steps below:
(i) Step 1: Examine available data for toxicity category determination. Since
acute dermal and skin irritation data may not always be available, use the following list in selecting
which data/signal word should be used for determining the acute toxicity category:
a. Consider acute dermal and skin irritation data on all a.i.(s) in the
product;
b. If acute dermal data are missing for any a.i., consider acute oral data on
that a.i. in addition to the primary skin irritation data on the a.i.
c. If acute oral and acute dermal data are missing for any a.i., consider the
skin irritation data on the a.i.;
d. If the acute oral, acute dermal, and skin irritation data are missing for
any a.i., consider the signal word of the registered manufacturing use
product for the a.i.;
e. If none of the above data is available on any a.i. in the product, consider
the signal word of the end-use product.
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(ii) Step 2: If any data used in Step 1, items a-e are toxicity category I or
otherwise require use of the equivalent signal word of "DANGER", then a notification statement is
required.
(3) Location of Statement
(a) All notification statements must be located in the DIRECTIONS FOR USE
section in the box with the heading AGRICULTURAL USE REQUIREMENTS.
(b) If notification is not required. The reviewer should make sure that the
statement about notification to workers is dropped from the General statement in the Agricultural
Use Requirements box. For example:
"... It also contains specific instructions and statements pertaining to statements on
this label about personal protective equipment (PPE), and the restricted-entry
interval."
g. Non-Agricultural Use Requirements
(1) If the label contains only uses within the scope of the WPS, skip this section.
(2) If the label contains or the RED requires entry restrictions, notification
requirements, or other instructions similar to WPS requirements that apply to uses NOT within the
scope of the WPS (non-agricultural uses), there should be a second box on the label called: "Non-
Agricultural Use Requirements."
(3) This box may be placed anywhere in the Directions for Use section of the label
after the Agricultural Use Requirements box.
(4) The following statements must be contained in the Non-Agricultural Use
Requirements box:
(a) "Non-Agricultural Use Requirements"
"The requirements in this box apply to uses of this product that are NOT within
the scope of the Worker Protection Standard for agricultural pesticides (40 CFR
Part 170). The WPS applies when this product is used to produce agricultural
plants on farms, forests, nurseries, or greenhouses."
(b) In addition, place into the Non-Agricultural Use Requirements box all the
entry restrictions, notification requirements, or other statements and instructions (except personal
protective equipment requirements) that apply to the non-WPS uses on the label. Examples: "Keep
children and pets out of the treated area until sprays have dried"; or, "Keep unprotected persons out
of treated areas until sprays have dried."
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VIII. DETERMINING THE CORRECT REI
Current as of August 2003
The correct REI may be specified in the RED Document. If a RED Document is not available,
refer to Supplement Three-A of PR Notice 93-7, or use the following guidance to determine the
correct REI.
A. REI(s) FOR FUMIGANTS. Current REI(s) will be retained or at the time of registration,
an REI will be determined on a case-by-case basis.
B. REI(s) DETERMINED BY SUBDIVISION D DATA (158.390). REI(s) will be retained.
C. ALL OTHER REI(s). Follow the steps below to determine the correct REI(s).
1. Step 1: Identify Acute Toxicity Data to Be Used in Determining REI(s)
a. REI(s) are based on the most severe acute toxicity category assigned to the acute
dermal, eye irritation and skin irritation data for all of the active ingredients (a.i.) in a product. In
many instances, these data are not always available. The following list indicates the preferred order
for selecting data on which to determine the toxicity category for each a.i.:
(1) Use the acute dermal, eye irritation and skin irritation data for the technical
product for each active ingredient;
(2) Use the acute oral and eye irritation and/or skin irritation data for any active
ingredient missing acute dermal data;
(3) Use the eye irritation and/or skin irritation data for any active ingredient missing
the acute oral and acute dermal data;
(4) U se the signal word of the regi stered manufacturing use product that i s the source
of the active ingredient which does not have any acute oral, acute dermal, eye irritation, or skin
irritation data;*
(5) Use the signal word of the product under review if none of the above data is
available on the active ingredient and if the active ingredient without data is not a registered
manufacturing use product.*
b. The following chart provides examples of howthe acute toxicity category is determined
for purposes of determining the REI.
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TABLE 7 - DETERMINING ACUTE TOXICITY CATEGORY FOR REI PURPOSES
Product A
VaiiaNc Acute To\ Data lor l\ach
Acli\c Inmvdicnl
Tox Cat
Tox Cal I 'scil lo
Determine Rl\ 1
single a.i.
Acute dermal tox data
Eye irritation data
III
II
II1
Product 1}
A\ailaMc Acute Tox Data for
I'ach Acli\c Inurcdicnl
Tox Cat
Tox Cal I'scil lo
Determine Rl! 1
a.i. #1
Acute dermal tox data
Eye irritation data
Skin irritation data
III
II
III
II
a.i. #2
Acute oral tox data
III
III
a.i. #3
Signal word of registered MP
(source of a.i.)
I
I2
1 The appropriate REI for Product A would be 24 hours.
2The appropriate REI for Product B would be 48 hours.
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2. Step 2: Determine appropriate REI(s) using the chart below and note exceptions*:
TABLE 8 - DETERMINING THE REI
Most Se\ere Tox Category I sed
lo Determine the Rill
1 .enulh of Required Rill
When the most severe tox category is III or IV
The REI is 12 hours
When the most severe tox category is II
The REI is 24 hours
When the most severe tox category is I
The REI is 48 hours
In addition:
If the product is an organophosphate ester that
inhibits cholinesterase and may be applied outdoors
in an area where the average rainfall for the
application site is less than 25 inches per year,
The REI is 72 hours.
*Exceptions:
1. If any existing interim REI, established prior to 10/20/92, is longer than the REI(s) shown in
the table above, the existing interim REI should be retained.
2. If a product bears REI(s) for uses not subj ect to the WPS, those REI(s) should be retained and
included in the "Non-Agricultural Use Requirements" box. If multiple REI's exist, follow
instructions for multiple REI's below.
3. Reduced Risk Restricted Entry Intervals to 4 Hours. To qualify for a reduction in the
REI to 4 hours products must meet the following criteria:
a. The active ingredient is in Toxicity Category III or IV based upon data for acute dermal
toxicity, acute inhalation toxicity, primary skin irritation, and primary eye irritation. Acute oral
toxicity data are used if no acute dermal data are available. If EPA lacks data on primary skin
irritation, acute inhalation, or primary eye irritation of the active ingredient, the Agency can review
data on that end-point for similar active ingredients (analogs), as long as it excludes such active
ingredients from consideration for the reduced REI, if the analog is in Toxicity Category I or II for
that endpoint.
b. The active ingredient is not a dermal sensitizer (or in the case of biochemical and
microbial active ingredients, no known reports of hypersensitivity exist).
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c. The active ingredient is not a cholinesterase inhibitor (N-methyl carbamate and
organophosphate) as these chemicals are known to cause large numbers of pesticide poisonings and
have the potential for serious neurological effects.
d. No known reproductive, developmental, carcinogenic, or neurotoxic effects have been
associated with the active ingredient. If the active ingredient does not have data available for these
chronic health effects, EPA considers data on appropriate chemical and biological analogs. Active
ingredients that have been classified as carcinogenic in Group B (probable human carcinogen) or
Group C (possible human carcinogen) chemicals for which quantification of potential risk (Ql*)
is appropriate, as well as those scheduled for the Health Effects Division's Cancer Peer Review
process, are omitted from consideration.
e. EPA does not possess incident information (illness or injury reports) that
are"definitely" or "probably'" related to post-application exposures to the active ingredient.
f. Some active ingredients are not included in PRNotice 95-3 because they have been the
subject of a Reregi strati on Eligibility Decision (RED) document which concluded that a 12 hour
or longer REI was necessary to protect workers. Active ingredients with REIs established during
reregi strati on activities are NOT eligible for reduced REIs. It should also be noted that WPS does
not apply to pheromones used in insect traps.
IX. LABELING STATEMENTS FOR SPECIAL SITUATIONS
A. CHEMIGATION STATEMENT (from PRNotice 93-7, Supplement 3, page 39)
1. Does the current labeling for an end-use product contain instructions for posting a
warning sign about chemigation?
a. NO: No action is necessary.
b. YES: Find those statements in your revised labeling and add the following statement:
"This sign is in addition to any sign posted to comply with the Worker Protection
Standard."
B. SOIL INCORPORATION/INJECTION/SEED TREATMENT (from PR Notice 93-7,
Supplement 3, page 39)
1. Does the current labeling for an end-use product contain instructions for incorporating
or injecting the product into the soil or planting medium?
a. NO: No action is necessary.
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b. YES: Include the following statement in the Agricultural Use Requirements box under
Item 4 which gives the restricted entry interval instructions:
"Exception: if the product is soil-injected or soil incorporated, the Worker Protection
Standard, under certain circumstances, allows workers to enter the treated area if there
will be no contact with anything that has been treated."
C. ENGINEERING CONTROL STATEMENTS (from PR Notice 93-7, Supplement 3, page
50)
1. Does the current product labeling contain any requirements or recommendations for the
use of closed systems, enclosed cabs, or open or enclosed cockpits?
a. NO: Do the following:
(1) Choose to add the following paragraph to the labeling:
"When handlers use closed systems, enclosed cabs, or aircraft in a manner that meets
the requirements listed in the Worker Protection Standard (WPS) for agricultural
pesticides [40 CFR 170.240(d)(4-6)], the handler PPE requirements may be reduced
or modified as specified in the WPS."
(2) To add this statement to your labeling, include it in the Precautionary Statements
section of the label under the heading "Engineering controls."
D. ULV AND LV USES (from PR Notice 93-7, Supplement 3, page 40)
1. If the product contains directions for use as a ULV or LV concentrate, do the following:
a. If the product does not have any PPE requirements, do nothing.
b. If the product does have PPE requirements and the product contains directions for use
ONLY as a concentrate, do the following:
In the Precautionary Statements section, change the standard heading of "Mixers and
Loaders must wear:" to "Mixers, loaders, applicators, and other handlers who may be exposed to
the concentrate must wear:" This heading will also replace the standard heading "Applicators and
other handlers (other than mixers and loaders) must wear:"
c. If the product does have PPE requirements but does not contain directions for use solely
as a concentrate, do the following:
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In the Precautionary Statements section, change the standard heading of: "Applicators and
other handlers (other than mixers and loaders) must wear:" to "Handlers who may be exposed to the
dilute through application or other tasks must wear:" AND also change the standard heading
"Mixers and Loaders must wear:" to "Handlers who may be exposed to the concentrate through
mixing, loading, application, or other tasks must wear:"
X. SAMPLE AGRICULTURAL USE REQUIREMENTS BOX
DIRECTIONS FOR USE
It is a violation of Federal Law to use this product in a manner inconsistent with its
labeling.
Do not apply this product in a way that will contact workers or other persons, either
directly or through drift. Only protected handlers may be in the area during application.
For any requirement specific to your State and Tribe, consult the State/Tribal agency
responsible for pesticide regulation.
AGRICULTURAL USE REQUIREMENTS
Use this product only in accordance with its labeling and with the Worker
Protection Standard, 40 CFR part 170. This standard contains requirements for
the protection of agricultural workers on farms, forests, nurseries, and
greenhouses, and handlers of agricultural pesticides. It contains requirements
for training, decontamination, notification, and emergency assistance. It also
contains specific instructions and exceptions pertaining to the statements on
this 'label about personal protective equipment (PPE), notification to workers,
and restricted-entry interval. The requirements in this box apply to uses of this
product that are covered by the Worker Protection Standard.
Do not enter or allow worker entry into treated areas during the restricted entry
interval (REI) of hours. The REI is 72 hours in outdoor areas where average
annual rainfall is less than 25 inches a year.
PPE required for early entry to treated areas (that is permitted under the Worker
Protection Standard and that involves contact with anything that has been
treated, such as plants, soil, or water), is:
- coveralls over long-sleeved shirt and long pants
- chemical-resistant gloves such as barrier laminate or viton
- chemical-resistant footwear plus socks
- protective eyewear
- chemical-resistant headgear
Notify workers of the application by warning them orally and by posting
warning signs at entrances to treated areas.
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Chapter 11 DIRECTIONS FOR USE
I INTRODUCTION
A. This chapter outlines the basic elements of the Directions for Use portion of the label and
provides a review strategy for ensuring that this information is presented in a clear, concise and
effective manner. Label writers and reviewers should keep in mind the distinction between
mandatory statements and advisory/recommended information, and try to write the label statements
accordingly. See PR Notice 2000-5
B. PURPOSE OF DIRECTIONS FOR USE. The "Directions for Use" section of a pesticide
label describes how the product may legally be used and how the product must not be used. The
requirements for the directions for use section are found in the regulations at 40 CFR 156.10(i), but
generally speaking the information necessary is as follows:
- the pest(s) that the product may be used to control;
- the sites where the product may be used;
- the application methods that are required or preferred;
- how much pesticide should be applied and the rate of application;
- whether there are any restrictions on use for factors such as weather, time of day, season
of the year, contamination of sensitive areas, exposure of nontarget species, etc.;
- the application methods that are prohibited;
- how often the pesticide should or may be applied;
- all restricted entry intervals (REIs) pertaining to existing uses, as applicable;
- maximum application rates (per treatment and per year);
- preharvest intervals (PHIs); and
- any other requirements as necessary
The directions for use reflect the Agency' s determination that the use of the product in such a
manner does not cause unreasonable adverse effects on the environment under FIFRA. The
Directions for Use section should be organized and carefully worded so that the directions are
understood by the person expected to use or to supervise the use of the pesticide. Sentences should
be written to indicate whether any actions mentioned are required, prohibited, encouraged, or
discouraged. Other sentences in the use directions may be used only to convey background
information.
C. FORMAT. Charts, tables, and graphics may be used in the Directions for Use section as
long as they do not contain or imply false or misleading information and they provide accurate
information in a clear, concise and complete manner. Instructions may be numbered if a true
sequence of actions is required.
D. CLARITY. The text in the Directions for Use section should be expressed in complete
sentences. These sentences should be direct and to-the-point, while covering all necessary
information. Directions should be expressed as clearly and concisely as possible. Long and /or
complicated paragraphs of narrative instructions should be avoided wherever possible. The label
reviewer should direct registrants to alter any text which appears to be incorrect, confusing, or
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contradictory to other label statements. If the reviewer knows what the registrant intends to write
(or what EPA permits to be written) on a particular matter, the reviewer can draft corrected text. IF
the reviewer cannot determine the registrant's intent, the reviewer should identify the area of
concern for the registrant, explain the problem with the information, and inform the registrant that
revised text is needed to meet FIFRA standards.
E. EXAMPLE. Consider the following statement taken from the Directions for Use section
of a pesticide product's label:
"Mix IV2 to 2 pints of (pesticide) in 100 gals, of water. Apply 100 to 200 gals, per
acre depending on spray equipment and tree size."
It is not clear to what the language "Apply 100 to 200 gals per acre..." refers. Does it refer
to undiluted product, or does it refer to the diluted spray solution? Is the applicator to simply add
more water to a 100-gallon spray mix to cover larger trees or to use twice as much of spray solution
mixed as directed by the first sentence?
Assuming that the "100 to 200 gals." refers to diluted spray mix, improved instructions would
be:
To make spray solution, mix IV2 to 2 pints of this product in 100 gals, of water. Apply 100
to 200 gals, of diluted spray solution per acre to trees depending on tree size and the coverage
obtained with the spray equipment used.
F. APPLICATION RATE. The actual application rate, ( e.g., how much product to apply per
unit area or per placement) must be stated in the Directions for Use. Labels for agricultural products
usually express the application rate in terms of pints/acre for liquid formulations, or pounds/acre for
solid formulation. The Directions for Use for an agricultural pesticide used in a spray solution also
must indicate the spray volume/unit area or other measurement of coverage, depending on the type
of formulation.
Labels for residential/household use products should express the application rate in smaller,
units, such as ounces, teaspoons/gallon, or pounds/square foot. Such rates and units of measure are
more appropriate for the home garden or yard. Any pesticide application equipment required by a
residential user should be readily available, like simple equipment such as drop-spreaders or hose-
end sprayers. The public generally does not have access to (and does not use) specialized
equipment. When percentages are included in application rates, it should be clear whether
percentages are by weight or volume and whether the percentage refers to the product or active
ingredient. Percentage application rates should never be used alone. The specific amount of product
to use per unit area should always be clearly stated in the Directions for Use.
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II. REVIEW STRATEGY FOR DIRECTIONS FOR USE
A. This section presents recommended strategies for reviewing the Directions For Use section
of pesticide labels. It also presents two different methods for reviewing the label and provides a
list of key questions that reviewers must ask as they review the label. It also discusses some
common problems and issues that reviewers face when reviewing the Directions For Use section.
Some draft labels may contain statements or information not acceptable according to FIFRA,
or the implementing regulations. Such statements must be corrected. In addition, various policy
documents including Pesticide Registration Notices provide guidance on particular issues. Label
reviewers should use the guidance along with the applicable laws to make case-by-case
determinations on the acceptability of label language.
B. TYPE OF LABEL REVIEWS FOR DIRECTIONS FOR USE
1. Me-too Application. If the application is a me-too submission (see chapter 4), reviewing
the directions for use is fairly straightforward: The label reviewer should make a side-by-side
comparison of the proposed set of use directions to the use directions on the label for the registered
product(s) which are identified in the me-too application.
Target pests or use sites found on the registered product's label may be omitted from the me-too
product's labeling. For example, a me-too application is made for an insecticide formulation to add
structural perimeter treatments for crickets, ants, and sowbugs. The registered product referenced
in the me-too application must be labeled for this site, and its label must claim crickets, ants, and
sowbugs; although other species (earwigs, millipedes) also may be claimed on the registered label.
While the pending submission need not have all the pests listed on the registered label, no new use
sites or pests or new public health pests may appear on the label for the pending me-too product.
The format for the presentation of use information on the me-too label need not be identical to the
format on the registered (cited) label as long as the critical information as described above remains
the same and the me-too product meets applicable legal requirements on labeling.
a. A major pitfall in side-by-side label comparisons is the possible presence of an
unacceptable use or other error on the label of the cited registered product.
(1) If an error is discovered in the Directions for Use section of the cited, registered
label, the reviewer must take the time to contact the registrant about the error(s) and request that the
registrant submit a corrected label within a suitable time frame such as 30 days. Upon the Agency's
approval of the corrected label the registrant generally is provided with 18 months to sell or
distribute existing stocks of the "old" label. 40 CFR 152.130(c). If there are risk issues associated
with error, the Agency can issue an order under section 6 or 13 limiting the time by which the
registrant can sell the existing stocks.
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b. If aReregistration Eligibility Decision (RED) Document has been issued for the active
ingredient in the product undergoing review, the reviewer must ensure that:
(1) all of the use sites on the label are in Appendix A of the RED;
(2) the site(s)/pest(s) are all eligible for Reregistration;
(3) if any one of the use sites is not in Appendix A, it may be a new use (see B.2.
below) or an old use that (i) has been subsequently modified by the RED or deleted from labels as
a risk mitigation measure or (ii) was not supported in reregistration. Products whose labels contain
such uses may not be reregistered;
(4) if any of the uses have been declared ineligible for reregistration, the use may not
be reregistered; and,
(5) if a favorable Reregistration Eligibility Decision document could not be made for
any of the uses due to a lack of adequate relevant data, the product labels may be accepted as
amendments to the registration if they are otherwise in compliance with the terms of the RED
document.
Further, if the product contains more than one active ingredient, all uses on the label must
be acceptable for all of the active ingredients. For example, an ethyl parathion/methyl parathion
product may only be used on the nine crops registered for ethyl parathion applications, even though
methyl parathion is registered for use on additional crops. If there is more than one a.i. in the
product and a RED is available for each, all sites on a label must be listed in each RED.
2. Non Me-Too Applications. When a registrants' s application is not for a me-too product
such as when a registrant proposes a new use, new application rate, preharvest interval (PHI)
change, or a other action not previously approved by the Agency, a more extensive review than the
simple me-too comparison is necessary. Such applications usually must be accompanied by relevant
data and/or data citations, and should be sent for technical review. The "Directions for Use" on the
proposed label may need to be altered due to the outcome of the science/technical review (i.e, use
rates on crops, PHIs, reentry intervals, restrictions such as bee hazard warning statements,
application rates and methods may have to be added or modified). The use rate, or application rate,
may be the most difficult part of this section to interpret and review. Application rates, and number
of applications per season for agricultural products may be affected by the residue data submitted
or cited by the registrant. Approval of most agricultural uses requires that an appropriate tolerance
be established because of the pesticide chemical residue on food..
C. ANALYSIS OF DIRECTIONS FOR USE. Once the type of review has been determined
for the submitted action, the label reviewer may proceed with an actual analysis of the Directions
for Use section. The reviewer must not assume that because a registrant claims to be modifying only
one part of this section that the rest of the directions for use are acceptable even though the label has
been accepted in the past. A complete review is necessary because:
- some labels may be very old,
- previously accepted uses and language may no longer be recommended
based on Agency guidance such as PR Notices
- some changes may be unannounced.
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Therefore, it is critical that the entire Directions for Use section be reviewed very carefully
before accepting the label.
D. KEY QUESTIONS TO BE ANSWERED WHEN REVIEWING THE DIRECTIONS FOR
USE SECTION.
The questions contained in the Label Reviewer's Checklist (Section IX of this chapter) should
be addressed when reviewing the Directions for Use section of the label. When answering these
questions the reviewer should refer, as appropriate, to:
- labels of substantially similar products for me-too applications,
- to the RED (if there is one),
- to the Registration Standard (if there is one not superseded by a RED), and
- for new or revised uses, to any science/technical reviews, or the efficacy reviewer.
- Current PR Notices must also be considered when using the Checklist. In addition, the
CFR 40, Part 180 should be consulted for published tolerances, or use the Tolerance Index System
(TIS) on the LAN.
The "Directions for Use" section can become very complex depending on the sites and pests
claimed. Individual Branches may have their own perspective on specific aspects of the "Directions
For Use" section. PM/team leaders, efficacy reviewer and fellow reviewers are the best sources of
such specific information to understand the contours of 40 CFR 156.10 and general policy
statements.
III. CONTENT
A. MANUFACTURING-USE PRODUCT (MP). If the pesticide is an MP intended only
for use by formulators preparing end-use products, the directions for use on the label may be greatly
reduced in scope. See regulation at 40 CFR 156.10(i)(l)(c)(iii). However, these products must still
have the following: 1) "Directions For Use" heading; 2) Misuse Statement(s); 3) The statement
"For Formulation Into A [type of pesticide]" followed by a continued statement of the uses
(crops/sites or other uses) for which the end-uses product (EP) may be registered and uses for
experimental purposes that are in compliance with FIFRA. Any MP registrants wishing to do so
may add one of the following statements to an MP label under "Direction for Use" to permit the
reformulation of their product for a specific use or all additional uses supported by a formulator or
user group:
a. "This product may be used to formulate products for specific use(s) not listed on the
MP label if the formulator, user group, or grower has complied with U.S. EPA data submission
requirements regarding the support of such use(s)."
b. "This product may be used to formulate products for any additional uses not listed on
the MP label if the formulator, user group, or grower has complied with U.S. EPA data submission
requirements regarding the support of such use(s)."
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In order not to confuse the user, products meant for manufacturing processes cannot also have
directions for use as an end use product, as the regulations states that manufacturing use products
must not get into the hands of the public except after incorporation into divided products. Note, in
some cases an MP may be labeled for specific end uses as well as for manufacturing uses; generally,
such products tend to be industrial-use products which may either be reformulated into EPs or
incorporated into various materials to produce treated articles (e.g.,wood preservatives, in-can paint
preservatives, etc). EPs may be used as an active ingredient source for other EP's, but the label for
such a source product may not include directions for its use as a MP and the label must bear the
same sites as the EP formulated from it. Pesticide products used for manufacturing products which
are not required to be registered (treated articles or substances, etc.) are considered to be end-use
products. Labels for such source products must bear complete Directions for Use sections.
B. PESTICIDE PRODUCT INTENDED FOR USE ONLY BY PHYSICIANS,
VETERINARIANS OR PHARMACISTS. Directions for Use sections on labels for products of
these types may be very limited in content. However, this provision applies only when the product
is also classed as a drug and regulated as such under the provisions of the Federal Food, Drug and
Cosmetic Act (FFDCA) (see 40 CFR 156.10(i)(l)(iii)(B)(3).
C. TYPICAL END-USE PESTICIDE PRODUCTS. The Directions for Use for typical end-
use products may appear on the container label and/or, may be securely attached to the packaging
as long as the container label makes reference to the attachment, [see 40 CFR 156.10(i)] and as long
as the reviewer has determined that it is not necessary for such directions to appear on the container
label and the label bears such as "See directions for use on enclosed brochure."
The manner in which information is conveyed in the Directions for Use section of many
pesticide labels varies greatly from label to label. Within categories of pesticides, specific formats
for the Directions for Use section may have been implemented through specific regulatory actions
on products. Such formats take precedence over the general information presented in this section,
but not over the requirements of 40 CFR, 156.10(i). As a result, the starting point for analysis of
directions for use for EP is the regulations.
Fortypical end-use products, the Directions for Use section will cover the following subsets
of information:
- standard requirements, such as the misuse statement, Worker Protection Standard boxes,
etc.
- lists of target pests for which control is claimed;
- lists of permitted use sites;
- restrictions and other limitations on use;
- general information about the product and its use
- specific application instructions
- "Storage and Disposal" instructions
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IV. STANDARD REQUIREMENTS
Special Reminder to Reviewers
Not only should the Directions for Use section provide basic application information, its
contents must also make sense. Any applicator, and especially the general consumer,
who is a nontechnical and occasional applicator, should be able to easily understand and
be expected to follow the directions for use.
A. All standard elements and language required by FIFRA and the applicable regulations to
appear in the Directions for Use must be placed on the label in the locations specified for them in
FIFRA or the applicable regulations. These elements should always be presented on the label, in
the following order:
- "Directions For Use Heading"
- Use Classification Statement
- Misuse and Related Statements
- Worker Protection Standard (WPS) Requirements (if applicable)
B. DIRECTIONS FOR USE HEADING. The heading of the Directions for Use section of the
label must be "Directions for Use." It may not have any other title. Headings such as "General
Directions," "UseDirections," "Recommendationsfor Use," "RecommendedUses," "HowtoUse,"
or any other similar wording are not acceptable.
The heading "Directions for Use" may be capitalized, put in bold type, and/or underlined to
give it proper emphasis. The heading must be of such prominence and placement on the label that
it is clear that all subsequent components of the section fall under the main heading "Directions for
Use". Such prominence can be assured by putting the heading in the largest, most conspicuous type
that is used in the section and by centering the heading on the label panel while left-justifying all
subheadings within the section.
C. USE CLASSIFICATION STATEMENT
D. MISUSE STATEMENT. All registered pesticides, including all end-use and manufacturing
use products, must bear labeling which has the following statement immediately below the Use
Classification:
"It is a violation of Federal law to use this product in a manner inconsistent with its
labeling."
1. Other statements relating to misuse, such as the following, are acceptable for residential/
household use products, and can be used in addition to and following the general misuse statement
mentioned above:
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- "STOP! - Read the label before using"
- "Use only as directed on this label"
- "Read label very carefully, including any special requirements which pertain to your
growing area."
- "Failure to follow all precautions and directions is illegal."
2. The general misuse statement to be used for experimental Use permits (EUPs), read as
follows:
"For Experimental Use Only" (40 CFR 172.6(a)(1)).
E. WORKER PROTECTION STANDARD. The Worker Protection Standard (WPS)
regulations (40 CFR Part 156, subpart K) require certain statements on the labeling of all pesticide
products within the scope of the WPS. Required WPS statements should appear after "the general
misuse statement" under the heading Agricultural Use Requirements (40 CFR 156.206). WPS
statements generally include the subheadings General Statements, Restricted Entry Interval (REI),
Notification to Workers Statements and Non-agricultural Use Requirements. Chapter 10 provides
the information necessary to determine whether the label under review is subj ect to the requirements
of the WPS and specifies how the WPS requirements must be presented on the label.
V. APPLICATION INFORMATION
A. CONTENT. This subset of the Directions for Use section should indicate use precautions
and restrictions that apply to all sites and pests claimed on the label. For products with many
registered uses, it may be useful and efficient to provide separate directions which pertain to specific
subsets of the sites and pests combination claimed for the product. In such cases, each site and pest
would have its own subsection which would be further divided into subsections such as "USE
RESTRICTIONS" and the other elements specific to that grouping. Some requirements specific to
how the products is to be applied might be more efficiently placed under subsections pertaining to
applications rather than under "USE RESTRICTIONS". The Use Restrictions subsection generally
indicate the following:
- the pests for which control is claimed;
- the sites where the product may be used;
- any FIFRA 2(ee) limitations statements;
- other use limitations and requirements such as those statements pertaining to Chemigation,
Spray Drift Labeling, seasonal restrictions, weather or time-of-day restrictions,
requirements intended to protect nontarget species or contaminations of food or feed
crops, and other basic requirements pertinent to safe and effective use of the product.
B. CHEMIGATION INFORMATION. Review of labels for agricultural uses, nursery uses,
uses on golf courses, sod farms or in greenhouses should be conducted with reference to the
guidance contained in PRNotice 87-1 (chemigation), unless the product is solely for residential use,
direct injection into plants, post-harvest application, or is applied as a gas or solid (pellets, tablets,
granules, or dusts). PRNotice 87-1 states that subj ect labels (as specified above) must either include
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the statement, "Do not apply this product through any type of irrigation system" or include labeling
statements regarding chemigation contained in PR Notice 87-1.
Any product used on agricultural sites that may be applied by chemigation should contain
information such as the following:
* Types of irrigation systems to be used;
* Consequences of improper chemigation;
* To whom questions about chemigation can be directed;
* Warnings against connecting irrigation equipment to public water supplies without safety
mechanisms;
* Personnel required for adjustment of chemigation equipment;
* Statements required for Toxicity Category I products;
Note: PR Notice 87-1 contains the complete wording of all the chemigation text categories
indicated above. Check relevant REDs for any chemigation text specific to the active
ingredient(s) in the product under review.
C. SPRAY DRIFT LABELING. As this edition of the Label Review Manual is being issued,
revisions to label language for Spray Drift are under way.
VI. GUIDANCE FOR WORDING APPLICATION INFORMATION. What goes in this
subsection will vary considerably according to the type of pesticide product and the intended user.
A. THE INTENDED USER. Although this information generally will not be stated
specifically on the label, it is very important to keep the intended user of the product in mind when
reviewing any pesticide label. For example, if the product is primarily intended for use by general
consumers or "residential/household users" the application sites listed on the label should be
appropriate for use on or in and around the home, yard, and garden, or on pets. Such sites might
include, home flower or vegetable gardens, ornamentals (shrubs and trees), home lawns, or
residential greenhouses.
1. If the product is intended for use only by veterinarians, then the label must state that
the product can only be used by veterinarians or physicians. The following statement is an
acceptable one to meet this requirement:
"This product may only be used by veterinarians/physicians." 40 CFR 156.10(i)(l)(iii)(B).
2. The phrases, "For use only by [a certain type of user]"; "For Commercial Use Only"
or "For Professional Use Only" should not appear on a product label. Such statements are often
used by registrants for marketing purposes, however, neither FIFRA nor the applicable regulations
provide for labeling statements such as for "professional use", "industrial use" or other such terms.
The registration process does not involve a determination that a product should be used, for example,
only by "service persons." Such statements are vague and they can mislead customers into believing
that a product with such a statement is somehow more efficacious than another product. Such
statements are also not likely to be enforceable under FIFRA.
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Note: The Agency can designate pesticides for "restricted use" if the Agency determines that
the product may cause unreasonable adverse effects without additional regulatory restrictions. See
FIFRA 3(d), see also 40 CFR Part 152 Subpart I. In that case, a restricted use product can only be
used by a certified applicator. ( The regulations at 40 CFR Part 171 set out the requirements for
certification of applicators.)
3. If the product is a termiticide, then the Agency has historically taken the position that the
label should contain the following statement:
"For use by individuals/firms licensed or registered by the State to apply termiticide
pesticide products. A State may have more restrictive requirements regarding
qualifications of persons using this product. To find out how to legally use this product
in your State, consult with your State's Pest Control regulatory agency."
It should be noted that although some of the above mentioned
statements restrict who can use the product, none of the statements
restrict who may purchase the product, unless the pesticide is
classified for restricted use. The only way to restrict sale of the
product is through classification of the product as a Restricted Use
B. THE PESTS BEING CLAIMED. The term pest is defined by statue and by regulation
in FIFRA 2(t) and 40 CFR 152.5. The label must clearly state the pest(s) (associated with a site)
that are controlled by the product. Pest claims may be made in the Use Restrictions section or with
specific application instructions. In addition, pest claims often may appear on the front panel as part
of the name of the product or in promotional statements appearing under the product's name or
elsewhere on the label.
1. Consistency of Listed Pests. Wherever the pests are listed on the label, they must be
consistent with pests listed elsewhere on the label. For example, if the front panel lists fire ants as
a target pest, then the directions for use must include the appropriate treatment directions for fire
ants. If the front panel lists several pests and then references other pests controlled by using phrases
like "and more," or "plus others" or "and many more," these phrases will only be acceptable if they
are followed by a direct reference to the Directions for Use section for the complete listing of pests
controlled, i.e., "and more listed on the back panel." The reviewer must make sure that the
directions for use are actually included and are applicable to all pests listed anywhere else on
the labeling. This consistency is necessary to ensure that the product is not considered misbranded.
2. Pest Groupings. While target pests may be named very generally in the directions for
use section of some labels (e.g., ants), other labels may identify them specifically, (e.g., carpenter
ants). In the case of public health antimicrobial products, however, each strain of a pest listed on
the label must be supported by appropriate efficacy data so that both the common and generic terms
may be used if appropriate. The directions for use should be determined by and reflect the strain,
location and behavior of the pest as closely as possible.
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3. Product Formulation and Pests. When evaluating the target pests it is important to
keep in mind the relationships among pests, application methods, and product formulations. For
example, a liquid formulation of a pesticide such as parathion restricted to foliar aerial application
would be unlikely to control soil-inhabiting insects such as corn rootworm larvae. If the reviewer
is unsure whether a formulation could be expected to control a certain pest on a label, the reviewer
must consult with the appropriate efficacy reviewer(s). The applicant must be informed if the
proposed use is not found to be acceptable. The applicant may appeal such a decision. Typically,
the applicant would then be required to supply information (such as product performance data) to
the Agency indicating that its formulation is appropriate for the proposed use.
4. Pests and Use Sites. The pests listed on the label should be appropriate for the
intended use sites for the product. For example, pests listed on the labels of residential/household
use products should be typical household/garden pests. An agricultural crop specific pest such as
the cotton bollworm would not be an appropriate pest claim for the label of a product intended only
for use around the home.
C. WHERE THE PRODUCT IS USED. All application ortreatment site(s) must be identified
on the label and clearly associated with the pest controlled. Many labels identify such sites near the
beginning of the use directions (e.g., in the "Use Restrictions" subsection) and/or in the text which
presents specific application directions.
1. Consistency of Listed Sites. Wherever the sites are listed on the label, they must be
consistent with sites listed elsewhere on the label. For example, if the front panel lists ornamentals
as a site, then the directions for use must include the appropriate treatment directions for
ornamentals.
2. Complete Site Information. Treatment sites must be clearly identified. For example,
if residential sites are listed as an application site, exactly where the pesticide is applied must be
specified, for example, bathrooms, kitchens, etc. Reviewers should require the use of the most
specific site terminology reasonable. If possible, refer to site indices in OPPIN to identify
appropriate site terminology but avoid the use of site categories (e.g., "domestic dwellings") that
would be awkward or confusing on a label. The use of uniform site terminology is useful for the
purposes of exposure reviews. The label reviewer may need to inform the registrant that the
application sites need to be identified more specifically, for example, cracks and crevices in kitchen
areas of residences instead of "dwellings".
3. Site Groupings. If the use site is indicated by a broad crop grouping, such as
"ornamentals," the registrant should be instructed to specifically identify sites on which the product
may be applied in the directions for use: "Ornamentals: Christmas tree plantings, conifer seed
orchards, and rhododendrons." In this example, the product user is restricted to using the product
only on those three use sites. However, if a use site were indicated as "Non-cropland industrial sites,
such as, airports, fence rows, roadsides, and associated rights-of-ways," then the user could use the
product on any place that would fall under the category as non-cropland industrial sites. Reviewers
should not accept an open-ended site list, including those extended by "such as" or lists ending with
"etc.", where food uses may be involved.
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4. Site-Pest Considerations. Site-pest combinations must be appropriate. Pests for
which control is claimed must occur as pests at the sites with which the label associates them.
Claims for control of a pest on or at an inappropriate site could mislead the user and possibly result
in a misapplication of the pesticide. Examples of inappropriate pest/site claims include: control of
algae in toilet bowls and brown dog ticks in commercial kitchens. If such inappropriate site-pest
combinations are detected during label review the registrant must be advised that such claims are
unacceptable.
5. Sites and the Intended User. The listed sites should be appropriate for the intended
end-user. For example, sites listed on the labels of residential use products should be typical
household/garden sites and not commercial agricultural sites such as cotton, tobacco, or cranberries.
D. USE-RELATED INFORMATION. Any other appropriate information (precautions or
restrictions) should be presented in the restrictions subsection unless such statements apply only to
some of the uses permitted by the label, in which case the statements belong with directions for
specific site and pest groupings. Use related information can include restrictions regarding the
timing of application, weather, soil conditions, geography, or other relevant considerations. This
information should be appropriate for the intended user(s), site(s), and pest(s) listed on the label.
1. Liquid Spray Instructions. Labels for liquid formulations generally refer to
"spraying" the product as the method of application. Labels which have directions which instruct
users to mix a spray solution should provide special instructions devoted to preparing spray mixes
and should indicate the spray volume to be applied per acre or per unit area. For some applications
it may be acceptable for the label to indicate, "apply sufficient volume for thorough coverage" or
similar language. The following types of spray applications are generally used:
Space Spray - dispersal of the product into the air by foggers, misters, aerosol devices
or vapor dispensers for control of flying pests and exposed crawling pests.
General Spray. Application to broad surfaces, such as walls, floors and ceilings.
Spot Spray. Application to small areas on which pests are likely to occur. These
areas may be on floors, walls, bases or undersides of equipment. To limit potential exposure in a
commercial food area, a "spot" should not exceed two square feet.
Crack and Crevice. Application of small amounts of pesticide into cracks and/or
crevices in which pests hide or through which they may enter a building. Such openings commonly
occur at expansion joints, between elements of construction and between equipment and floors.
If a label being reviewed uses any of the application terms mentioned above, determine
if the terms are appropriate, considering the general use patterns on the label.
2. Dust Formulations. For dust applications, a statement such as "apply uniformly for
thorough coverage of plant surfaces" may adequately substitute for a specific application rate.
However, a maximum application rate must be specified in order to avoid over-exposure.
3. Aerial Applications. For aerial applications, spray volumes must be stated.
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4. Spreader Settings. Spreader settings may vary from product to product. Such changes
in spreader settings are not usually considered significant.
E. HOW THE PRODUCT IS PREPARED AND HANDLED. Complete information on
how to prepare, handle and apply the pesticide product must appear on the label. In order to satisfy
the unreasonable adverse effects standard of FIFRA, label reviewers will, on occasion, need to
disapprove of or modify label language submitted by the application for registration. Such
modification may take the form of specific prohibitions ("Do not apply this product by use of
aircraft") or general statements limiting use to methods indicated on the label(" Apply this product
only by the methods listed and described on this label").
1. Formulation Type. Information regarding the product's formulation is essential for
the proper preparation, handling and application of a product. For example, the label must clearly
identify the formulation type of the product (dry, liquid, bait, or a gas, such as certain fumigants).
The label also must specify if the formulation is "ready-to-use" or a concentrate which requires
dilution and /or mixing. Aerosols, dusts, baits, granulars, and some liquids are examples of ready-
to-use formulations.
2. Mixing Instructions. Some products must be mixed or diluted with other materials
prior to application for pest control purposes. Labels for liquid formulation identified as
concentrates, and dry products identified as "wettable powders," must have directions for mixing
or diluting. Mixing directions must be as clear as possible, and presented in easily measurable units
(e.g., not "add 2.678 ounces to a gallon"). The units of measurement must be units by weight for
dry formulations (pounds, ounces), and units by volume for liquids (pints, quarts, fluid ounces) or
their standard abbreviations. One of the most frequent labeling errors observed is the use of "oz."
for liquids instead of "fl. oz." Metric units may be used in parentheses after the correct English
units. The diluent must be specified, even if it is water.
Dilution instructions may be presented in the form of a chart or table. Basically, the dilution
directions should state mix "X" amount of pesticide with "Y" amount of water (or other diluents
such as oil) to achieve a particular dilution, such as a 1% emulsion.
While the label may include a general statement such as " Use sufficient water to obtain
full coverage of foliage," the label also should give specific directions for the use site to indicate
the appropriate amount of spray volume to apply per unit area for aircraft or for ground equipment.
It also may be necessary for the label to indicate the diluent spray volume amounts for aircraft or
ground equipment.
3. Methods and Types of Equipment. When necessary the label must indicate the types
of equipment that may be used in applying the pesticide. The type of equipment should be identified
in a level of detail sufficient to promote safe and effective use of the product. For example, ground
and aircraft sprayers should be described by type and performance requirements (output and safety
specifications) to the extent that such descriptions are needed. The same concept applies to,
spreaders, injectors, burrow builders, and any other specialized equipment. Specific brands and
models of equipment should not be indicated unless specific information is provided to indicate that
only that brand and model are appropriate for reasons of safety or efficacy. Some types of
equipment are designed specially to apply particular types of pesticide or to interface with particular
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containers in which certain especially hazardous products are packaged. Use directions should
prohibit use of types of equipment known to be inappropriate for handling the product or any of the
mixtures that the label directs users to prepare. When the method of application and necessary
equipment are specific to each site and pest combination, they should be indicated in the directions
that pertain to each combination. The label reviewer should make sure that the methods of
application and equipment recommended are appropriate for the product formulation, the intended
user, and the site and pest to which the pesticide product is being applied. Complete information
on how to apply the product should be included. For example, the statement "Apply this product
to the soil" is not sufficient. Labels which state that the pesticide must be applied to the soil and
immediately incorporated, must specify what kind of equipment must be used.
F. USE RESTRICTIONS. General, or non-site- specific, precautions, restrictions or
limitations of the product comprise another important type of use restriction information in the
Directions for Use section. Such a restriction may consist of an imperative sentence- practically any
sentence that begins with a verb and ends in a period- or any other sentence which requires or
forbids certain action (See Section III of chapter 3 for discussion of mandatory labeling statements).
Use restrictions also may be phrased as requirements by using words such as "must", "never", and
"always". Any precautions and restrictions that apply to specific site(s) and pest(s), must be
included in the directions specific to that combination. Use restrictions may be required by the
Agency to meet the unreasonable adverse effects standard or proposed by the registrant or applicant.
Such restrictions may include, but are not limited to, the following categories:
- User Restrictions
- Rate Restrictions or Limitations
- Site, Pest, Timing, Weather, Soil, Geographic Restrictions
- Equipment, or Application Method Restrictions
- Miscellaneous Precautions such as Staining, Phytotoxicity, Incompatibility with Other
Products, etc...
- PHIs or Rotational Crop Restrictions (unless site-specific)
1. Appropriateness of Precautions and Restrictions.
a.. The reviewer must carefully assess each restriction or limitation to make sure
that it does not place on the product obligations that the user cannot reasonably carry out. For
example, an aquatic herbicide for use in ponds and lakes might have a restriction like: "POTABLE
WATER: Delay the use of treated water for domestic purposes for a period of three weeks or until
such time as an approved assay shows that the water contains no more than 0.1 ppm [herbicide
active ingredient]" Because any number of applicators could be using the product in public ponds
or lakes used by many households or municipalities, the applicator may have no reasonable way of
complying with such a restriction. Either another risk mitigation measure must be developed, or the
product should be given restricted use status.
b. Some proposed labels will contain various use restrictions desired by the
registrant, (e.g.,"Do not tank mix this product with [their competitor's products]," or "Do not use
this product for formulating other products," or other similar restrictions). Unless there is some risk
based reason for such use restrictions, such statements are not generally acceptable on product labels
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because they are false and/or misleading. Labels may prohibit use of the product on certain crop
varieties.
When used in reference to the response of crops and weeds to the proposed pesticide product (e.g.,
a herbicide label), registrants should use the word "tolerant" instead of "resistant." For example,
the label should refer to the use of the product on herbicide tolerant crops, not herbicide-resistant
crops.
2. Total Release Foggers. If the product label being reviewed is a total release fogger
that contains a highly flammable ingredient, the following label text must be included in the
Directions for Use, preferably with the general information:
"DO NOT use more than one fogger per room. DO NOT use in small, enclosed spaces such as
closets, cabinets, or under counters or tables. DO NOT use in a room 5 ft. x 5 ft. or smaller.
Instead, allow fog to enter from other rooms. Turn off ALL ignition sources such as pilot lights (shut
off gas valves), other open flames or running electrical appliances that cycle off and on (e.g.,
refrigerators, thermostats, etc.). Call your gas utility or management company if you need assistance
with your pilot lights."
3. Compatibility With Other Products. EPA will not accept or require a label
prohibition against the use of one pesticide product with another product unless that statement is
necessary to protect human health or the environment, or to prevent illegal pesticide residues under
Federal Food, Drug and Cosmetic Act (FFDCA). For example, a label statement prohibiting the
mixing of products, if mixing would cause an explosive chemical reaction, would be acceptable.
EPA will NOT accept a label prohibition against the use of one product with another which is not
necessary to protect human health or the environment. When compatibility with other pesticides
or liquid fertilizers is being addressed, the label should include specific instructions or recommend
ajar test.
VII. ADDITIONAL APPLICATION INFORMATION
This subsection of the Directions For Use may be given any of several headings, including
"Application directions", "How to apply" (especially for household/residential-use), and "Baiting"
as appropriate. In cases for which there is only one site/pest category but several application
methods, it may be appropriate to have separate application subsections for each method (e.g.,
"Area-wide Spraying"; "Spot Treatment", etc.). This subsection contains the specific instructions
and information needed to apply the product on each relevant crop/site for each target pest.
Directions may be grouped according to the sites and pests to be treated (e.g., broccoli, cabbage,
cauliflower: cutworms, fall armyworms, cabbage loopers). If geographical restrictions are required,
individual States or counties should be listed; geographical regions (e.g., Northwest) are
unacceptable because they are not specific enough to be enforceable. Unique, detailed sets of
application directions will be required for certain pests (e.g., fire ants, pocket gopher).
Fungicide grouping may be used ONLY if all pests occur and are controlled on all of the crops
in the group. Plant diseases are commonly specific to a site, (e.g., Black Spot on roses). Any
geographic restrictions need to be included with their appropriate sites/crops. Additional
information that may be included in these instructions, by site/crop and/or target pests, includes:
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A. PREHARVEST INTERVAL (PHI). If required to meet the FIFRA standard, the PHI
should be indicated as numbers of weeks or days. Other timing/application descriptions include
preplanting, at planting, post harvest, dormant, or delayed dormant. If one of these timings is
present, it should be so stated in the Special Directions Column. Preslaughter interval (PSF s) should
be expressed similar to the PHIs.
B. NET CONTENTS AND APPLICATION RATE. The directions for use may not call for
use of more than the net contents of the product's container (i.e., if a granular product is packaged
as a 1 lb. unit, its application rate should not require 200 lbs. of product). If the product is a liquid,
the specified treatment rate should be fl. oz. or gal. per unit area. If a solid, the rate should be
expressed oz. or lb. per unit area. [Note: Many labels of liquid formulations incorrectly omit the
"fluid" (fl.) with the oz. when specifying application rate.]
C. OTHER INFORMATION PERTAINING TO SPECIFIC APPLICATIONS. Other
information may include: method of application, equipment, application frequency (within the
requirements for tolerance, appropriate for controlling pests, etc.), minimum volume of diluent for
spraying for each type of equipment, application intervals, maximum amount of product or pounds
a.i. per acre per application, or per season or year, phytotoxicity effects or warnings, number of
applications per season and grazing or feeding restrictions. In cases where a maximim limit of
a.i./crop, season, etc., is required, ensure that liquid products include a statement of weight/volume
of either product or active ingredient.
VIII. STORAGE AND DISPOSAL INSTRUCTIONS
Labels for pesticide products are required to bear labeling instructions for the storage and
disposal of pesticides and pesticide containers. It is preferred that the Storage and Disposal
instructions appear at the end of the Directions for Use section. Information about, and requirements
for, Storage and Disposal instructions are given in Chapter 13. Also, please refer to PR Notice
2001-6 for further guidance.
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APPENDIX A - LABEL REVIEWER'S CHECKLIST
1. Does the label have the correct heading "Directions for Use"? Is the heading given sufficient
prominence so that it is clear to the reader that the entire intended "Directions for Use" section
falls under it?
2. Does the product have the required Misuse Statement? If the product has additional misuse
statements are they acceptable?
3. Does the label contain complete Directions For Use? Or are the detailed directions for use
omitted because the product is an MUP or for veterinary use or for use in non-pesticide
manufacturing?
4. Is the product subject to the WPS? If so, does the proposed label contain all the required,
accurate WPS information as set forth in the regulations and the guidance in Chapter 10?
5. Is there appropriate Storage and Disposal information on the label?
6. Should there be a General Instructions and Information sub-heading and section on the label?
7. Is the product subject to the guidance set out in PR Notice 87-1 (chemigation)? If so, is there
adequate chemigation information or a chemigation prohibition statement?
8. Does the label contain adequate spray drift labeling?
9. Should there be a Use Restrictions sub-heading and section?
10. Are the sites and pests identified? Are they identified consistently throughout the entire label?
11. Is the formulation acceptable for this site/pest combination?
12. If a RED has been issued, is the site eligible for Reregi strati on?
13. Is all equipment (e.g. for mixing, loading or application) identified/specified and is the
equipment practical for the user?
14. Are adequate preparation and handling instructions included?
15. Is the timing of the applications appropriate?
16. Are all methods of application appropriate?
17. Are General Precautions and Restrictions clearly presented as a group? Should they be?
18. Are the application rates indicated? Are they appropriate and calculated correctly? Do they
deviate from a standard use pattern?
19. Are there appropriate tolerances or exemptions from tolerance to cover all food uses?
20. Is the Pre-harvest Interval or Pre-slaughter Interval correct?
21. Is the application frequency acceptable?
22. Is the rate of application consistent with the packaging of the product?
23. Are site specific precautions and restrictions clearly listed with each site/pest combination?
24. If the product contains more than one active ingredient, are all the uses acceptable for all the
active ingredients?
25. Is there any unclear or ambiguous or contradictory language on the label?
26. Are the Directions for Use presented in the most effective, clearly understood and efficient way
possible? Could the label benefit from the use of chart or graphs?
27. Has the appropriate RED(s) been checked for any required labeling?
28. Are there any PR Notices that provide useful guidance?
29. Are label statements worded appropriately as mandatory or advisory?
30. Check 40 CFR 156.10 for further guidance.
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Chapter 12
LABELING CLAIMS
I. INTRODUCTION
This chapter provides guidance for reviewing claims made on proposed labels. For purposes
of this chapter there are three types of claims: 1) general claims, 2) claims associated with the
product name, and 3) efficacy related claims. This chapter also provides guidance on Warranty and
Disclaimer statements on labels and claims made in advertising.
II. GENERAL CLAIMS
A. Every pesticide must have labeling which is accepted by EPA before the pesticide can be
sold or distributed. Labeling is defined in the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) Section 2(p)(2) as meaning labels and all other written, printed, or graphic material
accompanying a pesticide or device at any time or to which reference is made on the label or in
accompanying literature. As defined in FIFRA Section 2(q)(l)(A), a pesticide is misbranded if its
labeling bears any statement, design or graphic representation which is false or misleading. FIFRA
Section 12(a)(1)(E) provides that it is unlawful for any person to distribute or sell any pesticide
which is misbranded. EPA's regulation, at 40 CFR 156.10(a)(5), provides examples of statements
that are considered to be misbranded; such as:
1. A false or misleading statement concerning the composition of the product;
2. A false or misleading statement concerning the effectiveness of the product as a
pesticide or device (EPA may review and approve or disapprove non-pesticidal
claims appearing on a pesticide label);
3. A false or misleading statement about the value of the product for purposes other
than as a pesticide or device;
4. A false or misleading comparison with other pesticides or devices;
5. Any statement directly or indirectly implying that the pesticide or device is
recommended or endorsed by an agency of the Federal Government;
6. 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;
7. A true statement used in such a way to give a false or misleading impression to the
8. Label disclaimers or warranty statements which negate or detract from labeling
statements required under FIFRA and EPA's regulations;
purchaser;
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9. Safety claims of the pesticide, or its ingredients, including statements such as
"trusted," "safe," "nonpoisonous," "noninjurious," "harmless" or "nontoxic to humans
and pets" with or without such a qualifying phrase as "when used as directed."
10. Non-numerical and/or comparative statements on the safety of the product, including
but not limited to:
a. "Contains all natural ingredients"
b. "Among the least toxic chemicals known"
c. "Pollution approved"
B. For certain aquatic use products, claims to reduce sludge and unpleasant odors in water or
to clean, clarify or deodorize ponds and lakes are not considered pesticidal claims; nor are claims
regarding the reduction of nutrients and organic matter in water, provided no claim is directly made
or implied that the reductions will result in reduced pest populations. The claims "Reduces critical
nutrients for cleaner, clearer ponds", "Ponds with algae need to reduce nutrients", and "Bacterial
Product to Control Excess Nutrients for Clear, Clean Ponds" imply pesticidal use and therefore
require registration.
C. Slime and odor control agents and other products expressly claiming control of
microorganisms of economic or aesthetic significance are not considered to be public health related,
but should bear accurate pesticide labeling claims. Registrants are still responsible for ensuring that
these products perform as intended by developing efficacy data which must be kept on file by the
registrant.
D. EPA's policy does not permit the use of the terms "natural", or "naturally" in the labeling
of any products, including biopesticide products, both microbials and biochemicals. These terms
cannot be well defined, and may possibly be misconstrued by consumers as a safety claim.
E. If a label reviewer is in doubt as to whether a claim or statement is false or misleading, he
or she should consult their divisions "Ombudsperson", or "OGC" before allowing the claim. PR
Notices 98-10 and 93-6 also provide guidance on claims, however, the statute and applicable
regulation control.
III. SOME EXAMPLES OF UNACCEPTABLE CLAIMS
A. Statements that imply or suggest that the product can or will prevent or control disease or
offer health protection.
B. "Commercial Line," "Commercial Size," "Institutional Size," "Garden Center Size": The
use of these terms for products clearly intended for consumer household use is misleading.
C. "Kills Numerous Insects," "Kills Many Insects," "Kills All Insects": These claims imply
a greater range of effectiveness than labeled. If however, these claims are limited to those pests
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listed on the label, i.e., "Kills many insects as listed below (or as listed on the label)," it may be
acceptable.
D. Claims about the Absence of an Ingredient: Statements or claims that express the absence
of certain ingredients are misleading statements prohibited by 40 CFR 156.10 (a)(5)(i) and/or 40
CFR 156.10(a)(5)(viii). These claims are examples of a true statement used in such a way as to give
a false and misleading impression to the purchaser. Even though a claim expressing the absence
of an ingredient is true, it would generally be considered to be misleading because if it falsely
suggests to the purchaser that the product is less risky, better, or more desirable than a product
containing the ingredient in question. Further, a product must not claim that it does not contain
an ingredient if it never contained the substance in the first place.
E. "Child Resistant Package" or Other CRP Related Claims: If a pesticide product requires
child-resistant packaging (CRP), and has complied with the CRP regulations in 40 CFR 157 then
the claim to that effect on the label is acceptable. Whether CRP is mandatory or voluntary the label
may indicate the use of CRP and the proper use instructions for the CRP. However, in no
circumstances may any safety claims beyond the statement "in CRP" be made due to the use of CRP.
F. Biodegradable: The term "biodegradable" is generally unacceptable for any pesticide
product. Except the term may be used only in reference to the package or packaging and then only
if the registrant certifies that the package breaks down and they provide information to support it.
Otherwise "biodegradable" may not be used on a pesticide label in any context.
G. Claims Such as "Prevents Infection," "Controls Infection", or "Prevents Cross Infection"
or that the product will control or mitigate any disease, infection or pathological conditions
constitute public health claims and are not acceptable.
H. The term "steri-" implies sterilant activity and is not acceptable as a product name or on a
product label unless it is a sterilant.
I. Statements that imply indefinite or all encompassing protection against bacteria, fungi or
algae such as "germ-free",or "algae-free" are not acceptable.
IV. PRODUCT NAMES
A. The name, brand, or trademark under which the pesticide product is sold shall appear on
the front panel of the label. See 40 CFR 156.10(b). No name, brand, or trademark may appear on
the label which is false or misleading, or has not been approved by the Administrator through
registration, or that the Agency has been notified of a name via supplemental registration, as an
additional name pursuant to 40 CFR 152.132, or by notification as allowed by PR Notice 98-10.
B. Product names cannot constitute false and misleading claims. Although a company has the
discretion to name its product, the company is still governed by the false and misleading standard.
An example of a misleading product name is, "Fresh Squeezed Disinfectant. " The phrase "Fresh
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Squeezed" in the name is misleading because it could convey that the product is meant to be
consumed. The Agency plans to issue a draft PR Notice which articulates a clarified position
concerning false or misleading product names. Until that notice is issued in final form, the
following is the Agency's current guidance:
1. Product names, claims or statements that express or imply a higher level antimicrobial
activity than demonstrated by testing are not acceptable.
2. General superlative terms such as "super," "superior," and "ultra" no longer need to be
qualified by the term "brand" in a product name. However, this determination still does not allow
terms or claims like those which clearly imply heightened efficacy (e.g., "hospital strength,"
"professional strength," etc.) (see PR Notice 93-6).
3. The Office of Pesticide Programs is under no obligation to ensure registrants use the
correct trademark™ and copyright© symbols on labels. Registrants are encouraged to use the
correct symbols.
4. If a product falls within the scope of the Worker Protection Standard and contains an
organophosphate (i.e., an N-organophosphorus ester that inhibits cholinesterase) or an N-methyl
carbamate (i.e., anN-methyl carbamic acid ester that inhibits cholinesterase), the label shall indicate
the term directly under the Product Name or in the first aid statement. 40 CFR 156.206(c)(1).
C. The exact same name cannot be used for different products registered by any one registrant.
The product name must be sufficiently different to clearly distinguish one product from another.
However, a supplemental distributor may use the same product name as the parent product.
V. EFFICACY RELATED CLAIMS
A. Even though registrants/applicants must conduct efficacy studies, the Agency only routinely
requires the submission of these studies for certain types of products. EPA reviews efficacy data
(also referred to as product performance data) when a pesticide product bears a claim to control pest
organisms that pose a threat to human health. Such pests include, but are not limited to, (a)
microorganisms which are infectious to man in any area of the inanimate environment, (b)
vertebrates (e.g., rodents, birds, bats, dogs, and skunks) that may directly or indirectly transmit
diseases to or injure humans, and (c) insects that carry human diseases (e.g., mosquitoes, ticks, etc.).
(40 CFR 158.640). EPA also requires submission of efficacy data to support claims for the control
of termites. On a case-by-case basis, the Agency may require substantiation of an efficacy claim.
B. The following points should be kept in mind when reviewing labels bearing public health
efficacy claims:
1. The terms "microbiocide", "microbicide", and "microbiostat" generally are not
acceptable on a public health product. If used on a nonpublic health product, the claim must be
qualified to indicate that the product does not provide public health protection.
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2. The term "biocide" generally is unacceptable on a public health product because it
implies that the product can kill all living organisms. It may be used on a non-public health product
provided it is qualified by directions for use or other statements that make clear the types of
organisms to be controlled.
3. True, non-misleading claims regarding the effectiveness of a product against target
pests, e.g., "kills roaches," "controls target pests," and "kills pests on contact" are acceptable.
However, such claims may not be exaggerated or used in a way that would make them misleading.
EPA may require additional efficacy data to substantiate claims which go beyond mere control of
claimed pests.
4. Terms which describe a specific level of efficacy and which are standard EPA-accepted
claims such as "bacteriostatic," "sanitizer," "disinfectant" and "sterilant" are acceptable.
5. Implied claims (e.g., any statement, design, graphic representation or brand name) of
heightened efficacy of a pesticide product by itself or as compared with another product or device
are false and misleading. Examples of such claims include, but are not limited to: "professional
strength," "extermination strength," "hospital strength," "industrial strength," "institutional strength,"
"super strength," "ultra strength," "maximum strength," "maximum efficacy," "extra strength,"
"double-strength," "triple-strength," "hospital grade," "high potency," and "high-powered"
(Reference: PR Notice 93-6).
a. Terms which function only to define a use site and which are not themselves
claims of heightened efficacy, provided that such terms are not used in a manner that is misleading,
are acceptable. For example, "hospital use" may be acceptable as long as it doesn't imply "hospital
strength", is not used in the product name and is not highlighted on the label to the exclusion of
other acceptable use sites.
6. Words or phrases that imply a product possesses unique characteristics because of its
composition are not acceptable. See 40 CFR 156.10(a)(5)(i). Examples of such terminology are,
"unique formula," or "strongest on the market." The claim "new" may be used on the labeling of
a product of new composition for a period of 6 months following approval of the labeling; however,
the word "new" may not be a part of the product name of record.
7. Claims that are inconsistent with efficacy established by testing are unacceptable. For
example, a claim of 30 second efficacy is not acceptable if testing and/or use directions require 2
minute contact time for efficacy.
8. Claims of efficacy based on an unsubstantiated, or improbable site/pest relationship are
unacceptable. A claim for control of Legionnaire's disease in cooling tower water is unacceptable.
C. INSTRUCTIONS TO LABEL REVIEWERS
1. Check with the efficacy reviewers if the label makes unusual claims, deviates from a
standard use pattern, or if the formulation changes (minor formulation changes in an antimicrobial
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product can alter the efficacy of the product; alternate formulations are not acceptable for
rodenticides). Request a formal efficacy review for all claims which differ significantly from
existing claims.
2. As mentioned earlier, do not allow any claim that would render the product misbranded
under FIFRA and 40 CFR part 156.10(a)(5).
VI. WARRANTY AND DISCLAIMER STATEMENTS
A. Warranty and Disclaimer statements containing language intended to limit liability of the
registrant or act as disclaimers or warranties for the product are generally covered by state law or
may fall under the jurisdiction of the Federal Trade Commission. The Agency will evaluate these
statements to assess to the extent that the statements impact FIFRA label standards or the Agency' s
implementing regulations. There are four types of label language associated with disclaimers,
warranties and limitations of liability that the Agency has found to be unacceptable under statutory
and regulatory standards. It is important to recognize that these statements must be assessed on a
case by case basis. They are as follows:
1. Overly broad statements negating or detracting from the Directions for Use or other
label language (including precautionary statements and directions for use). For instance, the
warranty statement, that the product would not work would negate Direction for Use which
explained how the product was to be used.
2. Label language asserting that the buyer has accepted the manufacturer's statement of
his/her respective rights, (e.g., manufacturer states buyer's rights are extremely limited; "all of these
conditions are beyond the control of registrant X"). Because these statements are almost always
incomplete (in terms of fully explaining a buyer's rights in the jurisdiction (state) of purchaser and
because they can mislead buyers into thinking that they have no legal remedy, they may constitute
"misbranding" under FIFRA.
3. Overly broad language implying buyer has no legal right to recover damages from
manufacturer (e.g., "all such risks shall be assumed by the buyer").
4. Because EUP labels must be used in strict accordance with the EUP program, the
warranty on EUP labels may not disclaim control over use. As with No. 2 above, these statements
can be considered to be misleading.
B. The reviewer should check the proposed label for warranty/disclaimer/liability language
statements (like those above) which appear to negate or detract from Directions for Use or other
language. The label reviewer should make sure that the disclaimer statement makes it clear that it
is the registrant's or manufacturer's warranty disclaimer, by using such statements like "To the
fullest extent permitted by law, the manufacturer shall not be liable..." or "It is the manufacturer's
intention that...". This way it is clear that the language is coming from the registrant (and not EPA).
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C. When a label reviewer is in doubt as to the acceptability of any warranty or disclaimer
statement, the statement should be referred to the Office of General Counsel.
VII. CLAIMS MADE IN ADVERTISING
A. Advertising and collateral literature or verbal claims for the product must not substantially
differ from any claims made on the label or labeling. See 40 CFR 12(a)(1)(B). In other words, if
a claim is not on the label or substantially differs from what appears on the label (or any part of its
distribution or sale which for example appears on a brochure), it cannot be made in advertising.
Although OPP does not routinely review advertising in connection with the registration, the Agency
may require advertising used in the marketing of the product to be submitted upon request and then
reviewed it to see that it is in compliance with FIFRA section 12(a)(1)(B). If reviewers come across
any advertising inconsistencies, refer them to the following address for further investigation:
Team Leader for Investigation Requests
Agriculture Branch
Agriculture and Ecosystems Division
Office of Compliance (2225A)
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Chapter 13
STORAGE AND DISPOSAL
I. INTRODUCTION
Labels for pesticide products are required to bear instructions for the storage and disposal of
pesticides and pesticide containers. 40 CFR 156.10(i)(2)(ix). Storage and disposal instructions
cover the appropriate storage of the pesticide product; disposal of any unused pesticide product or
any rinse liquids resulting from cleaning of pesticide application equipment; and the disposal of the
pesticide container. See also PR Notice 2001-6.
II. STATEMENT LOCATION
The storage and disposal instructions must appear grouped together, preferably blocked, within
the Directions for Use section, and under the subheading "Storage and Disposal" (See 40
CFR 156.10 (i)(2)(ix)). It is preferred that the storage and disposal instructions appear at the end
of the Direction for Use section. This placement eliminates the break between the heading
"Directions for Use" and the body of the use directions. Where the Directions for Use are contained
in a label booklet, at a minimum, the container storage and disposal instructions should appear at
the end of the Directions for Use on the container label. In addition, the disposal instructions should
be included in any referral statement on the label, e.g., "Refer to booklet for directions for use, and
storage and disposal instructions."
III. FORMAT
All products must bear the heading "STORAGE AND DISPOSAL ." The terms "residential,"
"household," "household-use," "homeowner," and "domestic use" are used interchangeably
throughout this chapter and mean the same thing for purposes of this chapter. These instructions
must be set apart and clearly distinguishable from other directions for use. 40 CFR 156.10(a)(2).
Blocking these statements with a solid line (a box) is suggested as a means of increasing their
prominence. For example:
STORAGE AND DISPOSAL
Do not contaminate water, food, or feed by storage and disposal.
Pesticide Storage . . .
Pesticide Disposal (old) or If partly filled (new) . . .
Container Disposal (old) or If empty (new) . . .
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IV. TYPE SIZE REQUIREMENT
The heading "STORAGE AND DISPOSAL" must be set in type of the same sizes as required
for the child hazard warning. See 40 CFR 156.10(i)(2)(ix) and the table in 156.60(h)(l)9iv).
V. DETERMINING STORAGE AND DISPOSAL LABELING
A. PESTICIDE STORAGE STATEMENTS. Review the information below to determine the
appropriate document to use as the source of pesticide storage statements.
1. Recent Registration Standard or Reregistration Eligibility Decision (RED)
Document. If a Registration Standard or RED Document exists, and is more recent than PR Notice
84-1 or PR Notice 84-5 (for fumigants only), refer to the Registration Standard or RED Document
for recommended storage statements. If the Registration Standard or RED Document does not
contain storage statements, use the general guidance contained in this section under A. 3. Storage
Guidance (below) from PR Notice 83-3.
2. No Registration Standard or No RED Document. If there is no Registration Standard
or RED Document, or if the Registration Standard or RED Document does not contain specific
storage statements, review the documents below to determine the appropriate document to use
as the source of guidance for the pesticide storage statements.
a. Statements for Specific Chemicals: PRNotice 84-1 and an errata sheet dated 4/12/84
contain specific storage statements for the active ingredients listed in Table 1 below:
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TABLE 1: PESTICIDE STORAGE STATEMENTS
Active Ingredient
Pesticide Storage Statements
Aluminum phosphide
The following statement should be used in addition to the guidance in PR Notice
83 -3: "Not for use or storage in or around inhabited areas."
Liquid Sodium
hypochlorite,
Liquid Calcium
hypochlorite
"Store this product in a cool dry area, away from direct sunlight and heat to avoid
deterioration. In case of spill, flood areas with large quantities of water. Product
or rinsates that cannot be used should be diluted with water before disposal in a
sanitary sewer. Do not reuse empty container but place in trash collection. Do
not contaminate food or feed by storage, disposal or cleaning of equipment."
Magnesium phosphide
The following statement should be used in addition to the guidance in PR Notice
83-3: "Store only in cool, dry, locked, and ventilated room. Protect from
moisture, open flames or heat."
Solid Calcium
hypochlorite
"Keep this product dry in a tightly closed container, when not in use. Store in a
cool, dry, well ventilated area away from heat or open flame. In case of
decomposition, isolate container (if possible) and flood area with large amounts
of water to dissolve all materials before discarding this container. Do not reuse
empty container but place in trash collection. Do not contaminate food or feed
by storage or disposal, or cleaning of equipment."
Terrazole
All manufacturing use products should contain the statement, "This product is
corrosive to steel and many other metals. Do not transport or store in unlined
metal containers."
Zinc phosphide
The following statement must be used in addition to the guidance in PR Notice
83-3: "Store in a dry place. Do not store in or around the home."
b. Fumigants. Refer to PR Notice 84-5 for specific storage guidance for the following
chemicals: methyl bromide; methyl bromide and 2% or less chloropicrin; aluminum and magnesium
phosphide; chloropicrin; sodium cyanide; ethylene oxide; and sulfuryl fluoride. For all other
fumigants, refer to number 3 below (Storage Guidance from PR Notice 83-3).
c. Storage Guidance from PR Notice 83-3. Review the general guidance on appropriate
pesticide storage instructions from PR Notice 83-3 listed below to determine if the label under
review is consistent with the guidance in PR Notice 83-3 Section I (A).
3. All product labels are required to have appropriate storage instructions. Specific
storage instructions are not prescribed. Each registrant must develop storage instructions for each
product considering, when applicable, the following factors:
a. 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.
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b. Physical requirements of storage that 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 temperature, potential for breakage of glass, crushing or damage
due to stacking, penetration by moisture, and ability to withstand shock or friction.
c. 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.
d. 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.
e. 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.
f. General storage instructions for household products should emphasize storage in original
container and placement in locked storage areas.
B. PESTICIDE PRODUCT DISPOSAL STATEMENTS. The label of each pesticide product
is required to bear pesticide disposal statements.
1. General Statement. The Agency historically has required all products, except for
residential/household use products, to bear the following statement for risk management purposes:
"Do not contaminate water, food, or feed by storage and disposal."
The Agency prefers that this statement appear immediately under the "Storage and Disposal"
heading because it concerns both subjects; however, the statement can be placed elsewhere within
the Storage and Disposal instructions.
2. Other Pesticide Disposal Statements. Review items a. and b. below to determine the
appropriate guidance to follow for pesticide disposal statements.
a. Registration Standard or RED Document Issued after 2/12/86. If the label under review
involves a chemical for which a Registration Standard or RED Document was issued after 2/12/86,
refer to the Registration Standard or RED Document to determine if any specific pesticide disposal
statements exist. If no specific guidance exists, refer to statements under number (2) below to
determine the appropriate pesticide disposal statement.
b. If the label under review involves a chemical for which a Registration Standard or
RED Document was issued before 2/12/86 or if there is no RED Document, consider the disposal
statements in the guidance set out in PR Notice 83-3 and described below.
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(1) Except those products intended solely for residential/household-use, the labels
of all products that contain active ingredients that are Acute Hazardous Wastes (see PRNotice 83-3
for list) or 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 inhalation toxicity should
generally bear one of the following pesticide disposal statements:
"Pesticide wastes are acutely hazardous. Improper disposal of excess pesticide, spray
mixture, or rinsate is a violation of Federal Law. If these wastes cannot be disposed
of by use according to label instructions, contact your State Pesticide or
Environmental Control Agency, or the Hazardous Waste Representative at the
nearest EPA Regional Office for guidance."
Alternatively, the disposal statement given for Furadan 3G and Furadan 4F in section C
below can be used.
(2) The labels of all products, except those intended for household use, containing
active or inert ingredients that are Toxic Hazardous Wastes (see Pr notice 83-3 for list) or meet any
of the criteria in 40 CFR 261, Subpart C for a characteristic hazardous waste must bear the following
pesticide disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess pesticide, spray mixture, or
rinsate is a violation of Federal Law. If these wastes cannot be disposed of by use
according to label instructions, contact your State Pesticide or Environmental Control
Agency, or the Hazardous Waste representative at the nearest EPA Regional Office
for guidance."
Alternatively, the disposal statement given for Furadan 3G and Furadan 4F in section C
below can be used if the first sentence is changed to "Wastes associated with the pesticide are toxic
hazardous wastes."
(3) Labels for all other products, except those intended for household use, must bear
the following pesticide disposal statement:
"Wastes resulting from the use of this product must be disposed of on site or at an
approved waste disposal facility."
(4) PR Notice 2001-6 provides new disposal instructions for non-antimicrobial
residential/household use products. The disposal statements specified in PR Notice 2001-6 for
products in pressurized containers and in non-pressurized containers are:
a. For products in Pressurized Containers
Do Not Puncture or Incinerate!
If empty: Place in trash or offer for recycling if available.
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If partly filled: Call your local solid waste agency or [toll free number which meets the criteria in
paragraph II.E] for disposal instructions.
b. For products in Non-Pressurized containers
If empty: Do not reuse this container. Place in trash or offer for recycling if available.
If partly filled: Call your local solid waste agency or [toll free number which meets the criteria in
paragraph HE] for disposal instructions. Never place unused product down any indoor or outdoor
drain.
Labels for antimicrobial household products may bear the following disposal statement:
"Securely wrap original container in several layers of newspaper and discard in trash," per guidance
provided in PR Notice 84-1. These products are not covered by PR Notice 2001-6.
3. Specific Pesticide Disposal Statements.
Furadan 3G and Furadan 4F
"Wastes associated with the pesticide are acutely hazardous wastes. Excess pesticide,
spray mixture or rinsate must be handled and disposed in accordance with local, state and
federal regulations. If these materials cannot be used according to label instructions or
cannot be returned and must be disposed, contact your State Environmental Control
Agency or the Resource Conservation and Recovery Act (RCRA) Hazardous Waste
representative at the nearest EPA Regional Office for disposal guidance."
C. CONTAINER DISPOSAL STATEMENTS.
1. All pesticide products, including household products, must bear container disposal
statements that are specific for each type of container. For non-antimicrobial, residential/household-
use products, PR Notice 2001-6 has replaced the earlier container-specific statements with revised
ones (see paragraph 2.a.(l)) below. Registrants still have the option of using more specific recycling
statements if they meet the Federal Trade Commission guidelines. Antimicrobial
residential/household-use products may use the revised statements but are not required to use them.
PR Notice 94-2 allows registrants, at their discretion, to use alternate container disposal
statements permitting the recycling of empty aerosol pesticide containers. The alternate statements
must specify that containers be emptied through normal use and note that recycling centers for
aerosol containers are not available in many areas. The alternate statements are in addition to the
disposal instructions.
2. Review sections a. and b. below to determine the appropriate document to use as the
source of the container disposal statements.
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a. Residential/household-use Products. If the label under review involves a chemical for
which a Registration Standard was issued after 2/12/86 or a RED has been issued, refer to the
Registration Standard or RED to determine if specific container disposal statements are provided.
If no specific labeling is provided or if no Registration Standard or RED exists, use one of the
following container disposal statements:
(1) "Securely wrap original container in several layers of newspaper and discard in
trash." (Reference PR Notice 84-1). Note that this statement has been replaced by a new instruction
in PR Notice 2001-6 which states, for non-antimicrobial, pressurized containers, "Do Not Puncture
or Incinerate! If empty: Place in trash or offer for recycling if available." and for non-antimicrobial,
non-pressurized containers, "If empty: Do not reuse this container. Place in trash or offer for
recycling if available." EPA will monitor for the new statements beginning October 1, 2003. Note
for partly filled containers specific language see PR Notice 2001-6.
(2) For aerosol containers, "This container may be recycled in aerosol recycling
centers. At present, there are only a few such centers in the country. Before offering for recycling,
empty the can by using the product according to the label (DO NOT PUNCTURE!). If recycling
option is not available, wrap the container in several layers of newspaper and discard in the trash."
(Reference: PR Notice 94-2) The phrase "wrap the container in several layers of newspaper and"
may be omitted from the instruction, per PRN 2001-6, so that it would read....option is "not
available...discard in the trash."
Note: The older allowable statement in 2.a.(l) above is identical to the older
statement required forthe disposal of residential/household-use pesticides. Consequently, the same
statement could serve as disposal instructions for the pesticide and the container.
b. All Other Products. If the label under review involves a chemical for which a
Registration Standard or RED Document was issued after PRNotice 83-3 (issued 3/29/83), refer to
the Registration Standard or RED Document to determine if specific container disposal statements
are provided. If no specific labeling is provided or if no Registration Standard or RED Document
exists, refer to Table 2 which provides the container disposal statements from PR Notice 83-3.
These statements are still applicable to all non-residential/household use products and antimicrobial,
residential/household use products.
c. Specific Container Disposal Language.
Furadan 3G
"Completely empty bag into application equipment by shaking and tapping sides and
bottom to loosen clinging particles. Then dispose of bag in a sanitary landfill or by
incineration, or, if allowed by state and local authorities, by burning. Otherwise, the bag
is an acute hazardous waste and must be disposed in accordance with local, state and
federal regulations."
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Furadan 4F
"Non-returnable Plastic or Metal containers: Triple rinse (or equivalent) and empty
rinsate into application equipment. Then offer for recycling or reconditioning, or
puncture and dispose in a sanitary landfill, or by other procedures approved by state and
local authorities. If rinsate cannot be used, follow pesticide disposal instructions. If not
triple rinsed, Furadan containers are acute hazardous wastes and must be disposed in
accordance with local, state and federal regulations. DO NOT cut or weld metal
containers."
TABLE 2: DISPOSAL STATEMENTS
Container Type
Disposal Statements
Metal Containers (non-aerosol)
Triple rinse (or equivalent). Then offer for recycling or reconditioning,
or puncture and dispose of container in a sanitary landfill, or by other
procedures approved by state and local authorities.
Paper and Plastic Bags
Completely empty bag into application equipment. Then dispose of
empty bag in a sanitary landfill or by incineration, or, if allowed by state
and local authorities, by burning. If burned, stay out of smoke.
Glass Containers
Triple rinse (or equivalent). Then dispose of in a sanitary landfill or by
other approved state and local procedures.
Fiber Drums with Liners
Completely empty liner by shaking and tapping sides and bottom to
loosen clinging particles. Empty residue into application equipment.
Then dispose of liner in a sanitary landfill or by incineration if allowed
by state and local authorities. If drum is contaminated and cannot be
reused, dispose of it in the manner required for its liner.
Plastic Containers
Triple rinse (or equivalent). Then offer for recycling or reconditioning,
or puncture and dispose of in a sanitary landfill, or incineration, or, if
allowed by state and local authorities, by burning. If burned, stay out of
smoke.
Compressed Gas Cylinders
Return empty cylinder for reuse (or similar wording).
Foil outer pouches of water
soluble packets (WSP)
Dispose of the empty outer foil pouch in the trash, as long as WSP is
unbroken.
Storage and Disposal
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Chapter 14 IDENTIFICATION NUMBERS
I. INTRODUCTION
The EPA Registration Number and the Establishment Number are required on all pesticide
products. The purpose of an Identification Number is to provide a unique product number for
regular registrations, distributor registrations, Special Local Needs registrations, and Experimental
Use Permits.
II. EPA REGISTRATION NUMBER
A. PURPOSE AND FORM OF THE REGISTRATION NUMBER. The EPA Registration
Number indicates which company holds the registration for the pesticide product, and in which
sequence the product was submitted to EPA by the company. For example, the first product
submission by a particular company will receive EPA file symbol -R which upon registration will
become product number one; the second will be two; and so on. The reviewer should see the
registration number preceded by the phrase, "EPA Registration No.", or "EPA Reg. No." This
phrase will be followed by a company number then a dash (-), and then the product number.
B. ASSIGNMENT OF REGISTRATION NUMBER. Before a pesticide product is registered
under the FIFRA Section 3, it is assigned an EPA File Symbol which is comprised of the company
number followed by a series of letters representing the potential product number. Product numbers
are assigned sequentially to each company. The letters are used to indicate that the product is not
registered. The letters come from the word "REGULATION." Each letter represents a number
starting with "1 (one)," and ending in "0 (zero)." Accordingly, R=l, E=2, G=3, U=4, L=5, A=6,
T=7, 1=8, 0=9, and N= 0. Therefore, if 6767-EGN were registered, it would become EPA
Registration Number 6767-230. "6767" is the number identifying the company holding the
registration and "230" is the number identifying that specific product.
C. LOCATION OF THE REGISTRATION NUMBER. The Registration number has no
required location on the label, but is usually found on the front or back panel of the product label,
and near the registrant's name and address. The registration number must be set in type and style
similar to and running parallel to other print on the section of the label where the registration number
is located. (40 CFR 156.10 (e)).
III. SUPPLEMENTAL DISTRIBUTOR NUMBERS
A. FIFRA and the regulations permit distribution or sale of a registered product under a
distributor's name and address (40 CFR 152.132). This is called "supplemental distribution."
Although distributor labels are not submitted to EPA for review or stamped accepted, questions that
concern them may arise from internal or external customers. The distributor label must be the same
as that for the federally registered product (basic registration) except for: product name, name and
address of distributor, distributor number, establishment number (final establishment at which the
product was produced), and any claims (uses, for example) that are deleted from the label. No new
Identification Numbers
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claims may be added. Distributors may not amend their product labels separately. Only the basic
registrant can amend a product's registered label.
B. Subject to the exceptions above, this regulation was intended to ensure that labeling
statements made for a distributor product are identical to those made for the EPA-reviewed and
approved basic product labeling. The Agency will however, generally permit minor formatting
differences, such as different label colors and backgrounds, type styles or label sizes, provided the
text, prominence and location of labeling statements on the distributor product are identical to that
of the basic product and that the distributor label meets all applicable regulatory requirements.
C. The company's name cannot be abbreviated on a distributor label unless it is complete
enough to enable a reader to identify the company so that he/she may contact the company.
Company names must be clearly understood by the reader, so, for instance, multiple company
names that are confusing would not be allowed on distributor labels. The company name that
appears on the distributor label must be the same as the company name on file with the Agency for
the distributor's EPA company number and must agree with the company name on the supplemental
registration form. If multiple addresses appear on the label, the initial address should correspond
with the address that is in the EPA Company Name and Address File and on the supplemental
registration form. The label or container must show the "EPA Establishment Registration Number "
of the final establishment at which the product was produced.
D. Both a registrant's name and a distributor's name can appear on the label, but it has to be
VERY clear who is doing what. For example, the preferred wording, "Distributed by..."
(distributor) (see Chapter 15, Company Name and Address)
E. Distributor products must bear the EPA Registration Number of the basic product, followed
by a dash [-], and then followed by the distributor's company number. For example, Company A
has a registered product, Kill It Dead Herbicide, EPA Registration No. 262-598. Company A enters
into a supplemental distribution agreement with Company B as a distributor. The Agency receives
the necessary documentation substantiating this supplemental distributor arrangement and then
assigns to Company B the Number 10007. The herbicide marketed by Company B (under their
product name, Make It Brown Herbicide) must bear the EPA Registration No. 262-598-10007. An
EPA Registration Number consisting of three sets of numbers partitioned by dashes can readily be
identified as a distributor product. As discussed above, only Company A could amend this
registered label.
IV. EPA ESTABLISHMENT NUMBER
A. The Establishment Number is assigned by EPARegional Offices (domestic establishments)
and the Office of Enforcement and Compliance Assurance (OECA) (foreign establishments). See
40 CFR 167. A facility that produces pesticides must have a company number before an EPA
Establishment Number is assigned. The Establishment Number is not reviewed by the Product
Management teams. The PM teams only responsibility is to ensure that the number is formatted
correctly.
Identification Numbers
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B. PURPOSE AND LOCATION OF ESTABLISHMENT NUMBER. The Establishment
Number indicates the final establishment at which the product was produced. See 40 CFR 167.3
This number is preceded by the phrase, "EPA Est.," and may appear anywhere on the pesticide
product label or the immediate container but it must appear on the outer container or wrapper of the
product if the establishment registration number cannot be clearly read through the outer container
or wrapper. 40 CFR 156.10(f). It often is grouped together with the EPA Registration Number but
is not required to be. [Note: The Establishment Number may be changed by non-notification. See
PR Notice 98-10.] Because the reviewer may never see the actual outside container of the product,
the Establishment Number may not be shown on the draft product label submitted for review by the
company.
C. STATE DESIGNATION. As a matter of Agency practice, letters such as MO, AZ, or PA
appear after the producer's company number. These letters represent the state in which the product
was produced.
1. Example: an establishment number may be written as EPA Est. (Company No.)-MO-
1, which would indicate that the product was produced in the first establishment registered by that
company in Missouri.
2. Example: If corporation XYZ's company number is 98989, and the last phase of
pesticide production takes place at producing Establishment Number 002 in Hawaii, then the
Establishment Number for this product would read EPA Est. 98989-HI-002.
D. MULTIPLE ESTABLISHMENT NUMBERS.
1. The Agency permits the use of multiple establishment numbers on products on a case-
by-case basis provided that the registrants meet existing labeling requirements and follow the format
for multiple establishment numbers. Note: A company must be in place first, then the establishment
number may be set up to reflect both the state in which the establishment is registered and also,
which number it is in the state itself.
2. If a producer lists multiple establishment numbers, the establishment number for the
actual production site must be very obviously marked or highlighted, for example, with an arrow,
a notch, a bullet, etc. For instance, a label may list three establishments in two states, all of which
produce the product. One label can be used at all three establishments by marking the actual
production site. Use of the word "last" implies that sequential changes are made to the product at
various sites. If the product is changed as it moves from site to site, the label required would change
at each site so only one establishment number would be needed for the product label at each site
(assuming that it actually is a registered product at all sequential sites).
Identification Numbers
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V. SPECIAL LOCAL NEED (SLN) REGISTRATION NUMBER
A. The Special Local Need registration number (SLN number) is also known as a FIFRA
Section 24(c) Registration Number. These registrations are issued by the states to meet special local
needs. (40 CFR Parti 62) The number is written as "EPA SLN No." followed by the two letter state
designation, then the last two digits of the year of issuance, and finally a four digit number which
is the consecutive number of registrations that the registering state has issued in that particular year.
1. For example: If the company ABC applied for a section 24(c) registration in the State
of North Carolina and it was the 34th SLN registration accepted by North Carolina in the year 1995,
then the 24(c) registration number would be EPA SLN No. NC950034.
B. The EPA 24(c) registration number is assigned by the state and entered on the Application
for Notification of State Registration of a Pesticide To Meet a Special Local Need (EPA form 8570-
25). In addition, if the 24(c) registration is an amendment to a federal section 3 registration, the EPA
registration number of the federal product is also entered on the application form.
VI. EXPERIMENTAL USE PERMIT NUMBER
A. A person may apply for an Experimental Use Permit (EUP) under Section 5 of FIFRA to
develop data on either a new product or a new use site for a future FIFRA Section 3 registration.
EUP applications (EPA form 8570-17) are assigned file symbols, which are written as Company
Number-EUP-File Symbol. The file symbol is translated to an EUP registration number once the
EUP has been issued by the Agency and/or an associated temporary tolerance has been established.
Note the application for a permit may be denied. Refer to page 14-1, item IIB for information on
the translation of file symbols to registration numbers. (See 40 CFR 172.6 (a)(2))
B. For example: Company MNO, whose company number is 98979, applies for an EUP to
collect data on the crop kale and no tolerance is yet established for kale. It is given a file symbol
RLE until the EUP has been issued and the temporary tolerance has been established, if applicable.
If this EUP application is issued, the file symbol 98979-EUP-RLE will become EUP Number 98979-
EUP-152, indicating this is the 152nd permit for which this company has applied.
Identification Numbers
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Chapter 15 COMPANY NAME AND ADDRESS
I. INTRODUCTION
The company name and address of the registrant, the producer, or the person for whom the
product was produced must appear on the pesticide product label See 156.10(c). An unqualified
name and address given on the label shall be considered as the name and address of the producer.
For pesticide products distributed under a supplemental registration agreement (a.k.a.
"distributor agreement"), the name and address on the supplementally registered or "distributor
brand" pesticide product must be qualified by phrases such as "Manufactured for..." Distributed
by..." or "Available exclusively from..." to indicate that the name shown is not the basic
registrant of the pesticide product. (See Chapter 14, Distributor Numbers) The name and
address must be displayed prominently and within the range of type size that is required for all
label text. (See chapter 3). The company name and address may be placed anywhere on the
label, but is preferred on the front panel.
II. TELEPHONE NUMBERS
The Agency encourages each registrant to include a company telephone number or toll-free
hotline number along with its name and address. This number can be used by the pesticide
product user to obtain additional product information. Registrants may also include the National
Pesticide Information Center (NPIC) hotline number for emergency information on the pesticide
product label. The NPIC number, alone or along with a company phone number, may be placed
on the pesticide product label using the following statement:
"For information on this pesticide product (including health concerns, medical
emergencies, or pesticide incidents), call the National Pesticide Information
Center at 1-800-858-7378."
See PR Notice 97-4 for more information.
Note the National Pesticide Telecommunications Network (NPTN) is now called National
Pesticide Information Center (NPIC).
III. FOREIGN REGISTRANTS
Applicants for pesticide registrations must provide a U.S. address for correspondence.
40 CFR 152.50. Generally a registrant not located in the United States will designate an agent
who resides in the United States. See 40 CFR 152.50. All correspondence concerning the
pesticide product or any subsequent registration actions will be mailed to the resident agent for
the foreign registrant at the resident agent's U.S. address. Therefore, the resident agent's address
is considered to be the U.S. address of record for the foreign registrant.
Company Name and Address
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IV. NAME OF RECORD
In order to accurately track pesticide registrations the Agency must be able to link company
names appearing on product labels with company names appearing on registration documents.
Therefore, if a company changes its label to reflect that it is "a division of", "a subsidiary of"
or "doing business as" (DBA) another company, the Agency asks that the company also change
its registration documents on record at the same time.
V. COMPANY NAME AND ADDRESS CHANGES
Registrants are required to inform the Agency when there are changes to its company's
name or address. See 40 CFR 152.122. If a company changes its name or address, it must
inform the Agency of the change by sending a letter to the Document Processing Desk
(Distribution Code COADR), Office of Pesticide Programs, 7504C, U.S. Environmental
Protection Agency, Ariel Rios Building 1200 Pennsylvania Ave. NW, Washington, D.C. 20460-
0001. This allows the Agency to accurately track ownership of pesticide registrations, which is
critical to agency oversight of pesticide products. In practice, the Agency allows a registrant to
start using the new name as soon as EPA approves the change. A registrant may use the existing
label with the old name label until the next label printing or for 18 months, whichever comes
first. If the registrant is also a producer, the registrant must also inform the Office of
Enforcement and Compliance Assurance (OECA) (for foreign Establishments) and the EPA
Regional Office where the company headquarters is located (for domestic Establishments) of the
change of address in order to meet its obligations under Section 7 of FIFRA and 40 CFR Part
167.
Company Name and Address
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Chapter 16 GRAPHICS & SYMBOLS ON LABELS
I. INTRODUCTION
A. Graphics or symbols in addition to written text are permitted on pesticide product labels if
they are accompanied by explanatory text, are clear in their meaning to the reader, do not obscure
or crowd required label language, do not misbrand the product, and are not false and misleading.
Symbols may not be used in place of required text. Refer to the sections below for guidance in
determining whether graphics and symbols are acceptable or unacceptable based on applicable
regulatory standards. Consultation with the PM/Team Leader and/or Branch Chief may be
necessary. The regulations at 40 CFR 156.10(a)(5) provide examples of statements and
representations that are false and misleading; see also FIFRA 2(q)(l)(A) which provides that a
pesticide is misbranded if its labeling bears "false and misleading" designs or graphic
representations.
II. ACCEPTABLE GRAPHICS & SYMBOLS
A. Acceptable graphics and symbols on product labels should serve to enhance the
understanding of the accompanying text. Acceptable examples of graphics and symbols, which may
be added by notification (see PR Notice 98-10 for the procedure), include the following. Note,
however, that the label reviewer must carefully evaluate the graphics and symbols to determine that
they meet statutory and regulatory requirements.
1. Diagrams of how to open product containers.
2. Graphics which display spray patterns of nozzles and/or application patterns.
3. Pictograms located near the precautionary labeling statements that illustrate the
different exposure routes (oral, inhalation, and/or dermal) to pesticides.
4. Pictures consistent with the label text showing examples of places where the pesticide
may be used, such as in a household or on a specific commercial site.
5. Child hazard drowning pictogram and labeling (a picture showing a bucket with a child
turned upside down in the bucket negated with the universal nonverbal symbol for negation: a circle
with a diagonal slash through it). The pictogram can not be accompanied by the word
"WARNING", as it may be confused with the human hazard signal word for the pesticide product.
To avoid such confusion the Agency recommends the registrants use the word "precaution"or
"notice."
6. The "Mr. Yuk" symbol on the label and/or outer container of the pesticide product.
The "Mr. Yuk"consist of a green frowning face with its tongue hanging out. This symbol may be
used with the Skull & Crossbones when the product is a Toxicity Category I product used in or
around the home or pool where children may be present.
Graphics & Symbols on Labels
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7. Pictures illustrating appropriate protective gear.
8. Pictures illustrating proper pesticide use.
9. Kosher symbols.
10. Hazardous Materials Identification System/National Paint & Coatings
Association/National Fire Protection Association (HMIS/NPCA and NFPA) ratings systems for
hazard codes.
11. Use of a logo to indicate absence of chlorofluorocarbons (CFCs) in a pesticide
product. The logo must consist of the universal nonverbal symbol for negation - a red circle with
diagonal red slash through the circle - with
a. wording as discussed in PR Notice 92-2 immediately next to the
logo; and,
b. text set in type size of at least 6 points (the minimum type size permitted by
regulation).
III. UNACCEPTABLE GRAPHICS & SYMBOLS
A. If the draft label under review contains graphics or symbols that violate FIFRA e.g.,
12(a)(1)(b) or the applicable regulations e.g., false and misleading in 156.10(a)(5), then the label
reviewer must advise the registrant to remove these from the label. Examples have included the
following:
1. A food or flower pictured on a label which bears no directions for use on that food or
flower. For example, a picture of cherries may not appear on a label if the product is not registered
for use on cherries, or a picture of roses may not appear on a label if the product is not registered for
use on roses.
2. Pictures of people using a product without the required personal protective equipment.
Pictures of users must be consistent with personal protective equipment (PPE) requirements on the
label. For example, if the label requires that the applicator wear full chemical-resistant coveralls
with goggles, the label illustration cannot show a person wearing shorts and no protective eyewear.
3. Pictures of a pest not claimed to be controlled by the product.
4. Pictures that depict the fragrance of the product.
5. Pictures depicting food or food contact utensils even if food handling area treatments
are allowed on the label. Food items and food contact utensils are usually covered or removed
before the pesticide is applied.
Graphics & Symbols on Labels
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6. Pictures of persons applying pesticides in areas accessible to children, pets, and other
nontarget organisms when such products may only be applied in areas inaccessible to children.
7. Pictures of children unless the product is registered for use on children or the product
is registered for use in swimming pools.
8. Pictures of candy. Similarly, containers that look like food or candy are prohibited.
9. Symbols implying safety or nontoxicity, such as a Red Cross or a medical seal of
approval (caduceus).
10. Pictures of residential use sites when the label limits use of the product to commercial
or industrial sites.
11. The Mobius Loop (a recycling symbol in the shape of three chasing arrows forming
a triangle) or any other symbol on the printed label implying that the product could be recycled
when in fact it cannot be. If the packaging can be recycled, then it is appropriate for a recycling
symbol to be shown in an inconspicuous location on the container or package with the word
"package" printed near the Loop.
12. The EPA logo or any other Agency logo which implies endorsement by a government
agency, such as the Circle and Statement "In Compliance With WPS."
13. Symbols which contain the words "Slow Release Nitrogen" and "Organic" are not
permitted if the prominence of the symbol, large type size of the word "organic" and its position
relative to the words "Slow Release Nitrogen" make it unclear whether the word "organic" refers
to the fertilizer component or to the entire product.
IV. OTHER GRAPHICS AND SYMBOLS WHICH ARE ACCEPTABLE
A. The following graphics and symbols are considered acceptable and may be ignored during,
and are not part of, the label review.
1. The "Good Housekeeping Seal of Approval" is a limited warranty to consumers and
promises to refund the purchase price or replace the product if defective. While the Agency allows
this symbol to be placed on products, the agency does not endorse the warranty message provided
by this symbol.
2. Department of Transportation symbols indicating the hazard and flammability of a
particular pesticide product.
3. Bar codes which allow for easier scanning of prices in retail stores.
Graphics & Symbols on Labels
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Chapter 17 NET CONTENTS/NET WEIGHT STATEMENT
I. INTRODUCTION
The Net Contents/Net Weight statement indicates how much pesticide product is in the
container and must appear on the pesticide label pursuant to FIFRA2(q)(C)(iii). Usually draft labels
include the phrase "Net Weight:" or "Net Contents:" as a means of identifying where the statement
will actually appear on the final printed label. The applicable regulation at 40 CFR 156.10(d) does
not require the term/heading "Net Weight" or "Net Contents" to be stated on the label. Even so, the
Agency strongly recommends that the terms "Net Weight" or "Net Contents" be placed on the label
because it describes the amount of pesticide product in the container as opposed to the total weight
of the pesticide product plus the weight of the container.
II. LOCATION OF NET CONTENTS/NET WEIGHT STATEMENT
There is no required location for the Net Contents/Net Weight statement. The preferred
location is the bottom of the front panel below the company name and address. If the draft label
under review shows the Net Contents/Net Weight statement in some other location, the reviewer
should suggest that the statement be placed at the bottom of the front panel. The Net Contents/Net
Weight should be exclusive of any wrappers or other materials. 40 CFR 156.1(d)(1).
III. TYPES OF PRODUCTS/MEASUREMENT
A. Check the draft label to determine if the Net Contents/Net Weight statement is expressed
correctly. See 40 CFR 156.10(d)
1. Dry Formulations (includes solids or semisolids such as dusts, granulars, pelleted or
tableted baits, wettable powders, microencapsulated product, impregnated materials). The net
weight must be expressed as pounds or ounces.
2. Liquid Formulations. The net contents must be expressed in terms of liquid measure
at 68 F(20 C): gallons, quarts, pints or fluid ounces.
3. Pressurized Products (includes gases and aerosols). The net contents must be
expressed as pounds and ounces.
IV. EXPRESSION OF THE STATEMENT
Review the draft label to make sure that it meets the following requirements:
A. UNITS OF MEASURE. Conventional U.S. units of measurement are used on pesticide
labels. Pesticide labels may also declare net contents in metric units (liters, kilograms, etc.), so long
as U.S. units of measurement are declared. For example, "Net Contents: 1 gallon (3.785 liters)."
Net Contents/Net Weight Statement
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It is not acceptable to declare net contents ONLY in metric units. Directions for Use are treated
the same way. For example, in addition to expressing the application rate(s) in the required U.S.
units of pound per acre, the registrant may also elect to express the application in equivalent metric
units: kilograms per hectare.
B. EXPRESSION OF NET CONTENTS. The Net Contents must be stated in terms of the
largest suitable units. For example, for a package containing 26 ounces of pesticide product, the
label must state: "Net Contents: 1 pound (lb.) 10 ounces" rather than "Net Contents: 26 ounces."
C. CONSISTENCY WITH DIRECTIONS FOR USE. The Directions for Use on the label
must not require a quantity of pesticide product that exceeds the Net Contents/Net Weight of the
package. An example would be a granular product with the following label language:
"Net Contents: 1 pound, "that requires an application rate 5 lbs/acre. This problem often occurs with
baits used to control rodents.
Net Contents/Net Weight Statement
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Chapter 18 UNIQUE PRODUCT LABELING
I. INTRODUCTION
Certain specialty products pose a challenge to meeting the regulatory labeling requirements.
Package size, shape, and composition often dictate unorthodox approaches to attaching the
necessary information. While many labeling provisions of 40 CFR 156.10 are mandatory, other
provisions provide the flexibility necessary to address challenging specialty products. The following
examples have been accepted by the Agency and may be used as models for new and novel products
that may be developed in the future. Label reviewers must address each product on a case-by-case
basis, and determine whether the labeling meets applicable legal requirements.
II. MULTI-PACKS/CO-PACKS
A. A REGISTERED PESTICIDE PACKAGED WITH A NON-PESTICIDE. A registered
pesticide product, in one container, may be packaged with a non-pesticide component, such as an
adjuvant, in a separate container (which is to be added to the pesticide during mixing). These two
containers, combined in one package, may be sold as a single unit only if the adjuvant is referred
to in the Directions for Use on the label.
1. The two containers are distributed and sold as a single retail unit, and together comprise
the pesticide product. (See 40 CFR 152.3 and FIFRA 2(u) defining pesticide to include a "mixture
of substances"). If the two components are bound together with a shrink-wrap sleeve or in a box,
the full panel of the pesticidal component must be visible through the wrapping, or the label must
be duplicated and attached to, or printed on, the outermost container.
2. The regulation at 40 CFR 152.3(t) states that the "pesticide product" includes the
package intended to be distributed or sold. EPA has jurisdiction over the packaging and labeling
of any "non-pesticide" which is part of the package. This means that the Agency reviews and
accepts or disapproves of the non-pesticide that is packaged with the pesticide. The reviewer
examines the non-pesticide labeling to determine whether it contains any language that conflicts
with the pesticide label, but the reviewer does not actually stamp the non-pesticide label. An
example of such a non-pesticide would be an activator (such as potassium permanganate) which
accompanies a pesticide (sodium bromide). EPA reviews the labels for both products, but stamps
only the accepted pesticide label, noting any problems or changes needed for the non-pesticide label.
B. TWO OR MORE PESTICIDES PACKAGED TOGETHER. Two or more pesticide
products may be packaged in separate containers but sold together as a single unit and intended to
be tank mixed just before application. [FIFRA 2(u)]
1. Each container must bear, or be accompanied by, full labeling, and the full labels of
both containers must be visible. If the outermost packaging obscures any part of the labeling of the
pesticides, the full labels must be duplicated and attached to the outermost container. [40 CFR
156.10(a)(4)(i)]
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2. Policies regarding the labeling for multi-packs and co-packs are being clarified by the
Agency. Registrants should contact the Registration Division for additional information before
submitting registrations or amendments that feature multi-packs or co-packs.
III. SMALL CONTAINERS
A. Some containers are too small to contain all required label text. In such cases, it is
permissible to have text located on accompanying pamphlets which are considered labeling. The
Agency historically required certain information to appear on the label of small containers:
ingredient statement, signal word, skull and crossbones (when required), child hazard warning, EPA
Registration Number and EPA Establishment Number, the phrase "RESTRICTED USE
PESTICIDE" (if so classified), and a reference statement to any accompanying pamphlets. Outer
boxes, bubble packs, accordion-pleated attached labels, and plastic self-sealing envelopes containing
additional labeling have been accepted.
B. Whatever the approach, it is important to stress that ALL labeling must accompany the
product at point of sale, and that the immediate container must bear a statement referring the user
to the location of any additional labeling which is securely affixed to the container. All of this
labeling must be reviewed and accepted. Registrants are encouraged to consult with the Agency
about special labeling needs.
IV. SOLUBLE PACKETS
A. An increasingly popular means of packaging dry pesticides is the water-soluble packet. For
some chemicals, EPA has required water-soluble packaging to reduce exposure of mixer-loaders to
dust, vapor, or liquid pesticides. This method of packaging, however, presents problems in labeling.
Since the immediate container is the film, a strict application of the regulations would require front
panel text to be printed on the film itself. Although recent technological advances have made such
printing possible, most standard printing techniques and inks are not compatible with the polyvinyl
alcohol films. In order to accommodate this desirable method of packaging, the Agency has
accepted other labeling approaches. See PR Notice 94-8 for complete information.
B. The most widely used packaging is a tear-open foil envelope containing each soluble
packet; the foil envelope bears the required labeling. This foil envelope method has the added
benefit of protecting the soluble packet from moisture which could cause shelf-life problems.
Another acceptable method is a muffin-pan type of package where each packet is enclosed in a
depression with a tear-off top that seals each chamber. The tear-off top bears the required labeling.
C. A vital consideration in dealing with soluble packets is how to reduce the likelihood of the
user removing unlabeled packets from labeled containers long before use and then forgetting what
they are. Because laundry detergents and dry bleaches are also manufactured in soluble packets,
there is the possibility that pesticides could be mistaken as these products. The Agency believes that
simply packaging a quantity of unlabeled soluble packets in an outer container where they could be
easily separated from the accompanying labeling does not meet the FIFRA registration standard.
EACH packet must either bear identifying labeling on the film itself (where feasible) or on
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packaging immediately enclosing that packet. PR Notice 94-8 describes in more detail the
concerns the Agency has with pesticide products containing water-soluble packaging (See Chapter
10 for reduced Personal Protective Equipment for water-soluble packaging products subject to the
Worker Protection Standard.)
V. BULK CONTAINERS
Agricultural pesticides are often sold by dealers out of bulk tanks and pumped directly into
spray rigs or truck-mounted tanks brought to the dealer by the farmer or applicator. This method
of sale has the advantage of reducing the number of empty pesticide containers and the attendant
disposal problems. In such cases, the dealer is obligated to deliver the full label to the purchaser at
the time of sale. Such labels are supplied to the dealer by the registrant. Often registrants are using
smaller containers in the field filled with products from these bulk containers which are called
"Refillable Containers". The label reviewer must ensure that the label language does not preclude
the reuse of the container.
VI. FOREIGN LANGUAGE LABELING
A. Foreign language text, in addition to the full English text, is permitted in part or its entirety
on the product so long as it is a true and accurate translation of the English text. (See PR Notice 98-
10) A registrant may provide bilingual labeling on any product without notification. However, if
it is submitted, the Office of Pesticide Programs (OPP) currently does not review the translation for
accuracy or stamp/approve it. If the foreign text is inaccurate or goes beyond the reviewed and
accepted English labeling, the Office of Enforcement and Compliance Assurance may take
enforcement action. Products marketed in Puerto Rico can be labeled in English only or in English
and Spanish.
B. Some registrants have requested that they be allowed to translate just the signal word and
the statement used on the labels of products falling under the scope of the Worker Protection
Standard (WPS) in cases where they know that their product users are not fluent in English. This
is allowed by OPP. In cases where they are translating into Spanish, the Spanish signal word for
toxicity category I products is "PELIGRO" and for toxicity category II products is "AVISO." The
statement that appears on toxicity category I and II WPS products is as follows:
"Si usted no entiende la etiqueta, busque a alguien para que se la explique a usted
en detalle. (If you do not understand the label, find someone to explain it to you in
detail.)"
VII. PESTICIDES USED TO TREAT SEEDS
A. Pesticides bearing directions for seed treatment (as opposed to drill-box, planter-box, and
slurry treatments done by the farmer immediately before planting) are required to have either a dye
in the formulation unless there is a tolerance for residue of the pesticide. [40 CFR153.155(a).]
Products intended and labeled for use only by commercial seed treaters need not have dyes if the
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labeling clearly advises the user to add an EPA approved dye with the pesticide during the seed
treatment process. [40 CFR 153.155(b)(1).]
B. Below are EPA policy statements regarding seed treatment label statements about the use
of the treated seed for food, feed, or oil. See Criteria and Policy Notice 2170.1. For certain
products, the Agency has found these statements to be required in light of incidents involving use
of treated seed for food/feed purposes.
C. FOR COMMERCIAL SEED TREATMENT PRODUCTS
Treated seed must not be used for or mixed with food or animal feed, or processed for oil.
Seed commercially treated with a pesticide must be labeled as follows: "Treated Seed. Do not use
for food, feed or oil."
D. FOR HOPPER-BOX USE PRODUCTS, that is, if the product is intended for direct use on
seed at planting time:
1. "Do not use treated seed for food or feed purposes or process for oil. Treat only those
seeds needed for immediate use, minimizing the interval between treatment and planting. Do not
store excess treated seeds beyond planting time."
2. Dye used to color the treated seed must be an EPA approved dye. Refer to 40 CFR
153.155(c).
3. For seed treatment products that may be under the scope of WPS depending on the type
of treatment please add the following:
"Seed treatment on agricultural establishment in hopper-box, planted box, or other seed-
treatment application at or immediately before planting is within the scope of WPS, while
commercial treatment of seeds is not within the scope."
VIII. CHILD-ATTRACTING PACKAGING ("ATTRACTIVE NUISANCE")
A. From time to time, registrants package pesticides in containers attractive to children.
Bait-type pesticides for rodents and roaches have been marketed in little doll houses, fire trucks, and
other toy-like dispensers or containers that look like food containers, e.g., a milk-carton shape. The
Agency has not found these types of packages to be acceptable. It may be difficult for the reviewer
to determine the package style when the final printed label is only a printer's proof and is not usually
given a final review. However, certain types of products amenable to such unacceptable packaging
should be checked and if any doubt or suspicion arises, the applicant should be required to submit
the intended packaging before the product is registered. The Agency can require child-resistant
packaging when the toxicity criteria and use criteria are met. See 40 CFR 157.22.
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IX. SECONDARY CONTAINERS
A. There are limited cases (e.g., custom blenders at 40 CFR 167.3) where users of concentrated
products dilute and then use/store the product in a separate unmarked container (secondary
container). Although the Agency does not require labels on secondary containers, it will allow
registrants to provide labels to users for secondary containers that are used to apply or temporarily
store end-use pesticides as long as the labels that accompany the secondary container are "not
inconsistent" with the EPA approved label and the label includes the following information:
1. Product name;
2. EPA registration number;
3. Name and percentage of active ingredient, followed by the phrase "The product in
this container is diluted as directed on the pesticide product label. "
4. Signal word and precautionary statements from the registered label unless the
registrant has acute toxicity data supporting a lesser precautionary statements for the
diluted product; and
5. The statement: "Follow the directions for use on the pesticide label when applying
this product."
(Note to reviewer : There are also secondary containers which are not diluted, but are filled
from a large container to be used/stored in the field. These may need less or additional label
information. Contact your product manager or the for guidance.)
B. "Not inconsistent" means that the registrant has met the above conditions and that the
secondary labeling has no other statements which directly conflict with the approved pesticide label.
C. Registrants are not required to submit secondary labels for review by the Agency; however,
if the secondary label is inconsistent with the EPA approved label, the Agency will consider the
product misbranded. This guidance does not apply to hand-held containers used by structural pest
control operators.
X. CHILD-RESISTANT PACKAGING
A. Child-Resistant Packaging (CRP) is defined as packaging that is designed or constructed
to be significantly difficult for children under 5 years of age to open or obtain a harmful amount of
the substance contained therein in a reasonable time and that it not be difficult for normal adults to
use properly. See 40 CFR 157.21(b)
B. If the pesticide is subject to CRP regulations the registrant must certify (40 CFR 157.34)
to the Agency that the pesticide as packaged meets the standards set forth in the regulations (40 CFR
157.32). These standards are Child-Resistant Effectiveness (85% before demonstration, 80% after
demonstration, 42-51 months of age), Senior Adult-Use Effectiveness (90% 50-70 yrs old), product
packaging compatibility, and product-packaging durability (for its lifetime the product as packaged
must continue to meet the effectiveness and compatibility standards). An example of the proper
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CRP certification language is found in PR Notice 96-2. Additionally, a registrant must maintain
adequate records to substantiate the CRP certification for the life of the pesticide registration. The
Agency has exempted some products from CRP (i.e., prefilled, nonrefillable ant and roach
insecticide bait stations not designed or intended to be opened or activated in a manner that exposes
the contents to human contact). This exemption set out in the Federal Register is discussed in PR
Notice 97-9.
C. Any changes in CRP will require an amendment of the pesticide registration (40 CFR
152.44) and a new CRP certification, including its designation using the American Society for
Testing Materials (ASTM) standard D3475-95 "Standard Classification of Child-Resistant
Packages," should accompany the amendment. Agency approval is required before any packaging
change can occur. CRP changes are not notifications.
D. A pesticide product may be exempt from the CRP requirements if it is classified for
restricted use, if a package is a large size as defined in (40 CFR 157.24 (a)(2)), if the pesticide is not
toxic, or if an exemption is based on technical factors that preclude using the product. In the last
two cases, the exemption must be approved by the Agency before the exemption can occur.
XL ATTACHED LABEL BOOKLETS
OPP's preference is that the precautionary information be placed on the outside of the booklet
and that, if necessary, the Directions for Use be placed on the inside. However, reviewers need to
keep in mind what information would be left on the container if the booklet was detached, lost, or
damaged.
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Chapter 19 THE CONSUMER LABELING INITIATIVE
AND PESTICIDE LABELS
I. BACKGROUND
Pesticide product labels contain valuable information including what the product is intended
to control, how to use the product safely, how to dispose of it, and what to do in case of
emergencies. However, for a variety of reasons, many people do not receive the full benefit of the
information on the label. Potential reasons could be because some labels are too difficult to read,
or because people assume they know how to use the product, or because they aren't aware of the
types of information on the label. The Consumer Labeling Initiative addressed these issues.
A. WHAT IS THE CLI? In 1996, the Office of Prevention, Pesticides and Toxic Substances
(OPPTS), in cooperation with pesticide registrants and other interested parties, began the Consumer
Labeling Initiative (CLI). The CLI is a voluntary, cooperative partnership among federal, state, and
local government agencies, industry, and other interested parties working to improve product labels
on residential outdoor pesticides, indoor insecticides, and household hard surface cleaners in order
to improve consumer understanding of the health and safety and environmental, information
contained on household consumer product labels. The objectives of the CLI were to: 1) learn
directly from consumers how to provide the label information they want and need; 2) make essential
safety and appropriate use, environmental, and health information easier to find, read, understand,
and use; 3) help consumers make informed product choices-based on their own needs and values;
and, 4) help consumers use, store, and dispose of products safely.
B. CLI, PHASES I AND II. Phase I occurred in 1996 and consisted of three components:
1) qualitative consumer research, consisting of over 135 one-on-one interviews with people in five
cities around the country; 2) a literature review of relevant studies and publications; and, 3) a review
of the information and comments solicited by the March 1996 Federal Register notice that initiated
the effort. Phase II began in early 1997 and encompassed the remaining research done under the
CLI. It included quantitative and qualitative research with consumers, as well as several CLI
workgroups, made up of several CLI participants each, which addressed complex topics not easily
addressed by the quantitative research alone. The workgroups addressed how to present health and
safety and ingredient information meaningfully; how to revise the disposal instructions so they are
useful to everyone; and how to standardize messages on product labels (e.g., format, elements of the
message).
C. QUANTITATIVE RESEARCH. The quantitative survey results were proj ectable to the
entire population and the respondents were statistically representative of the United States; this
means the survey data are considered to reliably represent the whole population. The survey,
conducted in the Spring of 1998, had two parts: a phone survey to test people's ability to locate and
understand specific information on labels; and, a written survey which collected information on how
and when people read labels, what they read, what they understand, what they like and dislike about
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labels, and what changes they would like to see made. The phone and written surveys were
conducted for each of the three residential product categories: outdoor, indoor, and hard surface
cleaner products.
D. QUALITATIVE RESEARCH. Unlike quantitative research, qualitative research results
cannot be projected to a larger group. This type of research, done with interviews, focus groups,
etc., is used to provide insights into what the participants think or feel. The Phase II qualitative
research had two parts. There were interviews held in 1997 to determine consumer understanding
of the first aid statements on labels. The information from those interviews led to revised statements
which are clearer to consumers. The research also included 27 mini focus groups, with three to five
people each, which were held in three cities. The purpose of the focus groups was to try to verify,
learn more about, and test the information acquired from the written and phone surveys. CLI
participants designed numerous sample labels incorporating a variety of language and layout
changes based on the survey data. Focus group participants were asked to compare the various label
revisions against each other and with a standard sample label, representative of current label designs,
and explain their preferences to the moderator.
II. RESEARCH FINDINGS
A. Overall comprehension is high (except for ingredient names; environmental hazard
information for outdoor uses; and some first aid information).
B. Consumers asked for clear, concise, easy-to-read information that connects consequences
with actions. Consumers prefer directions to provide specific time references where appropriate.
For example,"do not reapply for 1 week"; "do not re-enter treated area for 4 hours."
C. Label comprehension can be improved by using standardized formats; this increases ease
of use and encourages more frequent label reading.
D. Consumers preferred important information be set off, boxed, highlighted, or somehow
made to look different from the rest of the text.
E. Outdoor pesticide users read labels more often and more completely than do indoor
insecticide users who in turn read labels more completely than household cleaner users. This often
seems to be related to the reader's familiarity with the product, and or how complex the product is
to use.
F. For the three product categories, the label information read in the store and before use
include: brand name, directions for use, a description of what the product does, a description of
where not to use the product, and precautions concerning the effects on personal health/kids.
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G. For the three product categories, respondents indicated that the following information
is important, and they would like to locate it easily. 1) Directions for use; 2) Description of what the
product does; 3) Description where not to use the product; 4) Precaution concerning the effect on
personal health/kids; and 5) Emergency information.
H. The information respondents found most difficult to locate is as follows:
For all three product categories - where the product should not be used.
For outdoor - first aid information and precautions for pets
and the environmental effects for wildlife.
For indoor - precautions on personal health.
I. In all three product categories, consumers always indicated that the least important of the
current label information are the environmental claims (e.g., contains no CFCs, contains no
phosphates), and the name of the manufacturer. In all three product categories, consumers ranked
disposal, storage, ingredients, and a phone number as a grouping of the next least important label
information to them.
J. In all three product categories, given a description of different formats, consumers
preferred a box format on the label, like the nutrition facts box that presents information consistently
among products in the category.
K. The most frequent reasons given for not reading storage and disposal information in the
store was that it is "information they already know," followed by "just don't read it."
L. Besides the packaging, respondents identified the top sources to which they refer for
product information to be:
Indoor insecticides - store displays, TV ads, friends/family/co-workers, product brochures,
and magazine ads.
Outdoor pesticides - store displays, product brochures, friends/family/co-workers, store
salespersons, and TV ads.
Household cleaners - TV ads, friends/family/co-workers, store displays, magazine ads,
product brochures.
M. Consumers don't understand the real purpose of the signal word (Danger, Warning,
Caution) that appears on every product and conveys the level of hazard of the product. All three
words do convey some level of concern to readers, but most readers thought the manufacturer chose
whatever word they wanted, they didn't realize the words are assigned based on science.
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N. Less than half of consumers look for ingredient information; only 3% of consumers
voiced a need for a complete listing of ingredients. When presented with a variety of ingredient
statement formats, options listing functional categories of the ingredients and their purpose were
preferred.
III. MAJOR RECOMMENDATIONS FROM CLI
The CLI participants used the findings from the data to develop a set of recommendations
for label changes and label education. The major recommendations addressed three categories: label
changes; educational activities; and the workgroup issues. All the recommendations were approved
by EPA. Some recommendations have already been incorporated into the Label Review Manual,
as well as other Pesticide Registration Notices. Note: Other recommendations remain to be
implemented.
A. LABEL CHANGES. The major label recommendations follow.
1. Recommended the use of more bulleted text rather than long narrative formats;
the use of simpler, less technical language; the inclusion of more white space; the use of more tables
and graphics as appropriate; and, where a recognizable sequence of events occurs, that the steps be
numbered.
2. Recommended that manufacturers be allowed more flexibility regarding the
content and location of the ingredient statement;
3. Recommended the addition of short phrases describing just the major hazards
under the signal word on the front label.
4. Recommended that the Federal misuse statement be revised to something simpler
and easier to understand. The statement currently reads "It is a violation of Federal Law to use this
product in a manner inconsistent with its labeling."
5. Recommended that registrants be allowed to delete the signal word from Toxicity
Category 4 products. EPA proposed this change in a 1999 Federal Register Notice concerning anti-
microbial products. The change was finalized on December 14, 2001 in
66FR 64759-64768.
B. EDUCATIONAL CHANGES. The recommendation was made to encourage and
continue the consumer education campaign. The education has been undertaken under the Read the
Label First! campaign and the campaign is continuing.
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C. WORKGROUP ISSUES. Additional work by OPP on the ingredients statement and
storage and disposal issues was recommended. The completed work on disposal is reflected in PR
Notice 2001-6, September 7, 2001. The work on the ingredients statement continues.
IV. FORMAT SUGGESTIONS BASED ON CLI RESEARCH
A. Labels should be presented so they are easy to read and understand by the user. The CLI
research, as well as other label research done around the world, shows that in many cases, charts,
graphs, symbols, or pictures can be used to help convey information. However, care needs to be
taken that the graphics actually do convey the message intended.
B. Subheadings, like paragraph headings in a book, help to organize the information and
also make it easier to find. The data also showed that information presented in a "bulleted" format
is easier to read and understand than longer narrative paragraphs, even when the same type size is
used. When more lengthy and complicated information is required, a tabular format may be easier
to follow.
C. Due to the variety in size and shapes of labels, not all the CLI format recommendations
may work on all labels; however, consideration should be given to them whenever feasible.
Products labels must remain consistent with applicable statutory and regulatory requirements.
D. The following is an example of a typical narrative format which has been used on labels
in the past.
PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS AND DOMESTIC ANIMALS
DANGER: Fatal if swallowed or absorbed through the skin. Do not
get in eyes, on skin or on clothing. Wear protective clothing and
rubber gloves. Avoid breathing spray mist. Wash thoroughly with
soap and water after handling and before eating, drinking or using
tobacco. Remove contaminated clothing and wash clothing before
use. Provide adequate ventilation of area being treated. Do not apply
to humans, pets, plants or contaminate feed, foodstuffs, dishes or
utensils. Cover and avoid spraying fish aquariums. Cover or remove
exposed food, dishes, utensils and food handling equipment.
E. The following are some suggested formats, based on the CLI data and recommendations.
1. Bulleted Format. When using the bulleted approach, the intent is not to leave
information out, but to make it visually easier to follow. Either partial, or complete, sentences can
be used. Any type of character could be used as the "bullet."
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PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS AND DOMESTIC ANIMALS
CAUTION
- Harmful if swallowed or absorbed through the skin.
- Avoid breathing spray mist.
- Avoid contact with skin or clothing.
- Wash thoroughly with soap and water after handling and before
eating, drinking or using tobacco.
- Provide adequate ventilation of area being treated.
- Do not apply to humans, pets, plants, or contaminate feed, food
stuffs, dishes or utensils.
- Cover and avoid spraying fish aquariums.
- Cover or remove exposed food, dishes, utensils and food handling
equipment.
DIRECTIONS FOR USE
It is a violation of Federal law to use this product in a manner inconsistent
with its labeling.
General Precautions/restrictions
- Use may damage marble surfaces.
Application Instructions
- Turn nozzle to "Spray" or "Stream."
For General Cleaning:
1. Hold nozzle 6-8 inches from surface.
2. Spray soiled area.
3. Wipe clean
4. For surfaces in direct contact
with food, a rinse is required,
when
To Control Mildew:
1. Pre-clean surface
2. Spray until thoroughly
wet.
3. Let air dry
4. Repeat weekly or
To Disinfect:
1. For heavily soiled surfaces
Directions.
2. Spray until thoroughly wet.
3. Let stand 10 minutes before wiping or rinsing.
new growth appears,
pre-clean according to General Cleaning
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2. Modified Paragraph Format. The modified paragraph format presents text in
a series of full sentences, like the old standard narrative format, but includes subheadings,
numbering, etc. to make it easier to locate information. If a paragraph format must be used, try to
help your reader out by including either subheadings, or highlighting key words/phrases, etc. Also,
the language should be simple and use correct grammar and punctuation.
Application Instructions:
BROCCOLI (PHI) : Pests; Application Method( Spray, Broadcast, etc.); Dose
(amount per unit area); Type of Equipment (Sprayer, Aircraft, Spreader, etc.); Timing (e.g.,
Spring, Foliar, Pre-plant, Pre-plant Incorporated, etc.); Application Intervals;
Phytotoxicity concerns as it applies to timing and method of application; Restrictions
(Grazing, haying, maximum dose per application, maximum dose per crop cycle or per year,
maximum number of application per year, etc.). Other comments which apply to this site.
CAULIFLOWER
FOR HOUSEHOLD USE: SHAKE WELL BEFORE EACH USE. Apply to
surfaces only. Hold container upright 12" from surface and spray. Spray until
surfaces are wet. Avoid over wetting asphalt tile, rubber and plastic materials.
Repeat treatment as necessary, but no more than once a week.
ROACHES, CRICKETS, SILVERFISH, SPIDERS: Spray directly on insects
when possible. Thoroughly spray cracks, baseboards, underneath kitchen shelves,
and other places where insects live. ANTS, EARWIGS: Spray door sills, wood
frames, outside foundations and porches. Spray directly on ant hills. FLIES,
MOSQUITOES, GNATS, WASPS: Apply on screens, walls, door and window
frames, and other surfaces where insects congregate.
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3. Tabular Format. When using a tabular format make sure that all the appropriate
information is included; that it is easy to follow; that types of information are clearly divided or
discernible; etc.
FIRST AID
If inhaled
•Move person to fresh air.
•If person is not breathing, call 911 or an ambulance, then give artificial
respiration, preferably by mouth-to-mouth, if possible.
•Call a poison control center or doctor for further treatment advice.
If on skin
or clothing
•Take off contaminated clothing.
•Rinse skin immediately with plenty of water for 15-20 minutes.
•Call a poison control center or doctor for treatment advice.
If in eyes
•Hold eye open and rinse slowly and gently with water for 15-20 minutes.
•Remove contact lenses, if present, after the first 5 minutes, then continue
rinsing eye.
•Call a poison control center or doctor for treatment advice.
If
swallowed
•Call poison control center or doctor immediately for treatment advice.
•Have person sip a glass of water if able to swallow.
•Do not induce vomiting unless told to do so by the poison control center
or doctor.
•Do not give anything by mouth to an unconscious person.
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CROP
PHI
TARGET
PESTS
RATE
SPECIAL DIRECTIONS
Broccoli
For use only in
California,
Oregon, and
Washington
Do not
apply
within
5 days
of
harvest
Aphids
Flea beetles
Leafhoppers
Whiteflies
fl. oz in _
gal of water
(diluent)
by ground or
gal of
water (diluent)
by aircraft
Method of Application
Spray, Broadcast,
Chemigation, Ultra Low
Volume, etc.
Equipment
Sprayer, Sprinkler Irrigation,
Mist Sprayer, Spreader etc.
Timing
Foliar, Pre-plant, Post-plant,
Post-harvest, Dormant, etc.
Application Interval
Can be - days as needed
or can be - days or as
needed.
Notes: (applying to a
specific pest)
Army worms
Lygus bugs
Higher dosage
than above
with same
amount of
diluent
Same as above but with
different timing, e.g., pre-
plant incorporated including
a different type of
equipment, e.g., tiller
Limitations:
1. Do not apply more than fl. oz. of Product per acre per
application
2. No more than gallons per acre per season or year
3. Make no more than applications per season or year.
Grazing Restrictions: Can apply to Grazing, Harvesting of Hay
or Green Forage.
NOTES: Can give information on phytotoxicity, pest resistance,
other general comments that apply to the site, etc.
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