United States [Environmental
Protection Agency
Office of Prevention, Pesticides
& Toxic Substances (7505C)
EPA737-B-964J01
December 1996
Label  Review Manual
2nd Edition
             • t •

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  TABLE OF CONTENTS
LABEL REVIEW MANUAL
Chapter 1.
Chapter 2.
Chapter 3.
Chapter 4.
Chapters.
Chapter 6.
Chapter 7.
Chapters.
Chapter 9. -
Chapter 10.
Chapter 11.
Chapter 12.
Chapter 13.
Chapter 14.
Chapter 15.
Chapter 16.
Chapter 17.
Chapter 18.
Purpose of Manual
Pesticides and Labeling    .• N
General Format and Legibility Requirements
Types of Label Review
PRATS Entry
Ingredient Statement
Use Classification      f ,
Precautiorairy Labeling
Environmental Hazards
Physical or Chemical Hazards
Directions for Use         /
Labeling Claims
Storage and Disposal 'V .  .
Graphics & Symbols on Labels
Company Name and Address
•  '    .    •  f  •    .. ;-i/     ;    •• -•   .  •
Contents/Net ^eight Statement
Identificationpfumbers
Unique Predict Labeling v
-•   •     .:.   I •.••':-." :.V  '•••'  . •
                                         Date Issued
                                         December 27,
                                         December 27,1996
                                         December 27,1996
                                        December 27,1996
                                              ber27,1996
                                        December27,1996
                                            mber27,
                                        December 27,1996
                                        December 27,1996
                                              XT 27,
                                              36T27,
                                           member 27,
                                           Ember 27,1996.
                                        December 27, 1996
                                        December27, 1996
                                        December 27, 1996
                                        December 27, 1996

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Label Review Manual
                      Current as of December 27,1996
Chapter 1
PURPOSE OF MANUAL
Purpose

       The Labeling Unit maintains this manual to serve as a training tool for Office of
Pesticide Programs (OPP) employees and as guidance for product management team members
who are responsible for performing label reviews. The goal of the manual is to improve the
quality and consistency of labels. In addition, this manual may be very useful for state label
reviewers, registrants and other pesticide label writers.

       It is important tonote that it is the responsibility of the label reviewer to consider all
chemical and product specific information affecting labeling such as science reviews, Pesticide
Regulation (PR) Notices, and Reregistration Eligibility Documents (REDs) when reviewing
product labels, not just the manual alone.

Content

       The first two chapters of this manual provide a definition of a pesticide and what
constitutes a pesticide label 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 chapter which contains additional information.  The remainder of the manual
provides the reviewer with step-by-step instructions concerning the review of a pesticide label
and any associated actions such as the Pesticide Registration Action Tracking System (PRATS)
entries for label reviews and situations where the Confidential Statement of Formula (CSF)
affects the label language.  Information in  the manual is arranged in the order of use by
reviewers. The last chapter provides information about how unique labeling issues have been
handled in the past, so that reviewers can apply this information to future similar situations.

Approach

       The chapters of this manual have been numbered independently to aid futureupdating.
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.

       This manual provides a systematic approach to the label review process. Most label
reviews involve cite-all(me-too's which reference another's label) products which are not
accompanied by data. In the past, such labels were usually reviewed by comparing the new
product label to aregistered label. When reviewers compared new proposed labels to registered
Purpose of Manual
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Label Review Manual
Current as of December 27,1996
labels, whichmaythemselveshavecontainederrorsorbeenout-of-date, often deficiencies were
not discovered or eliminated. Consequently, the label errors were perpetuated. Thismanual
attempts to shift trie review of the label away from solely a label-to-label comparison to a
review based on the guidance contained in this manual  which is supported by labeling policy
documents. This labeling guidance has been gathered from aU of OPP's various labeling policy
documents issued over time, and is kept current. The manual is just one additional tool to aid
in the review of a label. The label reviewer is reminded to also consult all sources of chemical
and product specific information that could affect the labeling, such as science reviews, PR
Notices, REDs, etc.

Availability                                •

1     INTERNALLY: All chapters in this manual are included in the Labeling Policy
      Directory,  which   is  located  under   F:\SHARED\RD\LABELING,
      Q:\SHARED\RD\LABELING, and R:\SHARED\RD\ LABELING on OPP's Local
      Area Network (LAN). For DOS users it can be accessed by activating a macro in
      WordPerfect (WP) by typing Alt L in any WP document or at a blank screen, once the
      macro has been copied to your machine. The policy directories contain all policy
      documents  (such as memos, relevant PR Notices,  etc.) related to labeling. In the
      manual, chapters are organized roughly following the sections of a pesticide label. The
      reader should refer to the INDEX under the directory for the chapter names.

      Policy Directory References:      .

            Throughout the manual, documents contained inthe Labeling Policy Directory
            are referred to in the following manner:
                                     ,      v •  i       • i        '  •,'
            FRNotices                ,    LFR-##
            PR Notices                     PR-yr-##    '
            Miscellaneous documents         MLD-##
            Memos, letters, etc.              LPyr-##
            Policy and criteria notices        ####.#
            Standard operating procedures    ####.#
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Label Review Manual
Current as of December 27,1996
2.     EXTERNALLY: The manual is available from the National Technical Information
       Service (NTIS) in Springfield, Virginia, To order documents from NTIS, call 703-487-
       4650 or TDD 703-487-4639.  The manual is also available in electronic form on
       FedWorld, an information service of NTIS. Electronic access to FedWorld can be
       made through Internet-telnet to: fedworld.gov, or connect via modem by dialing 703-
       321-3339, with the settings Parity=none, Data Bits=8, Stop Bit=(N-8-l), with terminal
       emulation-ANSI or VT100. FedWorld aceomodates speeds up to 28,800 baud. The
       manual can also be obtained through the  Internet at: gopher.epa.gov.  Plans are
       underway to make the manual available on the internet via EPA's home page. For
       additional information,  contact  the Labeling Unit at 703-308-8641. After March 1,
       1997, call 703-305-7102.                                              •

Maintenance/Update                      ,                           .

       For accurate maintenance of this manual, it is imperative that everyone in OPP bring
to the attention of the Labeling Unit any document which affects generic labeling policy.

       If other discrepancies or problems are noted, they should be brought to the attention
of the Labeling Unit by calling 703-308-864L After March 1,1997, call 703-305-7102.
Purpose of Manual
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 Label Review Manual
                         Current as of December 27,1996
 Chapter 2
PESTICIDES AND LABELING
 Introduction                         '                         .

       This chapter focuses on ho w a product is determined to be a pesticide or a non-pesticide.
 Label reviewers should use these criteria when discussing the status pf products or potential
 products with other EPA staff, state enforcement personnel, registrants, applicants, or the
 general public. While it is acceptable to discuss with anyone the various points affecting the
 decision concerning whether or not a product is  a pesticide and subject to the Federal
 Insecticide, Fungicide, and Rodenticide Act (FIFRA), the final decision must be in writing and
 should  be in response to a written  request which includes  proposed labeling and the
 composition of the product.  This chapter also covers state specific labeling requirements.

 Pesticides Subject to Registration

       One of the most important words in FIFRA is "intended" Products are considered to
 be pesticides if they are  intended for preventing, destroying, repelling, or mitigating any pest
 or intended for use as a  plant regulator, nitrogen stabilizer, defoliant, or desiccant.  Intent is
 determined by claims on the label and/or composition/mode of action of the product as
 distributed or sold.

 1.    CLAIMS: If the manufacturer, formulator, packager, or shipper makes claims on
      labels, advertising, collateral literature, or even verbally, that a product has pesticidal
      or plant regulator utility, then the product is subject to FIFRA.

 2.    COMPOSITION: Even in the absence of pesticide claims, if a product is composed of
      rngredientsthatareweU-lrnownpestiddesthatha
      the product is considered a pesticide. Forexample; a company markets a granular 2,4-
      D product that has labeling identifying the presence of 2,4-D, directions to apply it to
      lawns at a certain dosage rate, and warnings about over-application, but nowhere is
      there a claim that broad-leaved weeds will be killed. Is it a pesticide? Yes! Since 2,4-D
      is a well-known herbicide and has no other utility.

 3.    MODE OF ACTION: Even if pesticidal claims are not made for the product and the
      active ingredient is not currently recognized as a pesticide active ingredient, the mode
      of action of the product may be pesticidal in nature. In such cases, the product would
      be considered a pesticide if the product has no other non-pesticide utility. The label
      reviewer should require the producer/manufacturer to supply information on how the
Pesticides and Labeling
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Label Review Manual
                          Current as of December 27,1996
             *                  , ฐ  '           . •   '         '         *   - '
      product works to determine themode of action. If the mode of action is determined to
      be pesticidal in nature, then the manufacturer of the product must be notified that the
      product is a pesticide and regulated under FIFRA.

      For further details on determining whether a substance is considered a pesticide, refer
to 40 CFR 152.3(8), 152.8, 152.10, 152.15,  152.20, 152.25, 152.30, and 153.125 .
prvn>ptinns
SilhlRCt to
                                     Ak
       Certain pesticides, materials or compounds have been determined not to be subject to
regulation  (However, the reader should be aware that this exception does not necessarily
extend to the Federal Food, Drug and Cosmetic Act (FFDCA).) Examples of products not
subject to FIFRA:           ,             ."            ,

ซr     Certain Pesticide Substances exempted by the 25(b) Rule :  Minimum Risk
       Pesticides^ CFR 152.25) as per FR Notice Volume 61, Number 45 (March 6, 1996)
    '   (Reference: LFR-08). (See the notice published in the Federal Register, September28,
       1994 (59 FR 49400) for the list of .minimum risk inerts (List 4A inerts)).

•*•     Multi-purpose substances that make no pesticidal claims.

•r     Materialsthatprovideaphysicalbarrieragaii^
       active ingredients. Examples are sphagnum moss used as plant growth media to retard
       damping-off; latex or asphalt tree wound dressing label that contain  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 repel insects (40 CFR 152.10(c)).

 •r     Materials that arc naturally pest-resistant as long as claims are not made for pest
       mitigation beyond the material itself. Examples  are cypress or redwood lumber or
       outdoor furniture that have claims of repellency or resistance to wood-boring insects
       and wood-rot fungi.

 •r    Materials that have been treated with a pesticide to protect the material itself
       and claims are not made for pest mitigation beyond the material provided the treating
       pesticide is registered. Examples are shower curtains treated with a fungicide to retard
       mildew growth, lumber treated with a wood preservative, bathroom caulks impregnated
       withamildewcide, paints with antimicrobials addedforin-canpreservation, fabrics and
       leather treated with sanitizer compounds, etc.  NOTE: the above examples are limited
 Pesticides and Labeling
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 Label Review Manual
Current as of December 27,1996
       to the treated articles themselves.  The pesticides used for those purposes must be
       registered and bear appropriate directions for such uses. (40 CFR 152.25(a)).

       Paints that have been treated with an antimicrobial pesticide and bear claims that
       the dried paint film will be resistant to mildew. Claims, expressed or implied, may not
       be made for protection of the surface beneath the paint film nor 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 NOT subject to the above exemption
       and, therefore, are considered to be pesticides.

       Products that, are intended solely to be used on or in the living bodies of man or
       other animals: Such products are regulated by the Food and Drug Administration
       (FDA). Athlete's foot remedies, dandruff medications, head and body lice soaps and
       lotions, aquaculture and aquarium additives for treatment offish diseases, dermal
       disinfectants, aresomeexamples of excepted pesticide products (40 CFR 152.8(a)). The
       foregoing  exceptions are due to the definition of "fungi" in Section 2 of FTFRA.
       IMPORTANT:   These  exceptions  apply  only to  antimicrobials  (fungicides,
       disinfectants, viricides, etc.).  Insecticides are hot included in the "living body"
       exception. Thus, products such as mosquito repellents, flea and tick remedies for pets,
       and other insecticides and acaricides used directly on the living body of humans, pets,
       and livestock ace considered to be'pesticides and are required to be registered.

       Mortuary supplies intended to prevent or mitigate mold and bacteria on or in
       human cadavers:  The rationale for this extension is that the use is limited to
       embalmersand morticians who are specially trained to handle such products and do not
       require the protection afforded by registration. No other portion of the living public
       would be exposed to such products (40 CFR 152.25(c)(l)).

       Animal and animal organ preservatives (40 CFR 152 25(c)(2)).

       Adjuvants, extenders, spireader-stickers, protectants, and other products that 1
       have no pesticidal properties in and of themselves, but are intended to be used in
       conjunction with pesticides, when sold separately from those pesticides.  However,
       diluents other than water must be specified in the Directions for Use and approved
       during registration.

       Plant nutrients, fertilizers, trace elements, and other products intended solely for
       providing necessary nutritional needs of plants for vigorous growth: There is a
Pesticides and Labeling
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Label Review Manual
Current as of December 27,1996
      fine, and sometimes not-so-fine, line between plant nutrients, which are exempt from
      registration, and plant regulators, which require registration. Whether a product should
      be 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.  Thus, claims for increased blossom set, stimulation of root
      growth, prevention ofsucker growth, delayedonset of sprouting ofharvested root crops
      and abscission stimulation for fruit crops are considered to be plant growth regulator.
      In this area, the composition of the product may aid in making the determination.
      Compounds such as auxins, cytokmins, and gibberellins have no other uses except as
      plant regulators. Therefore, the declaration of the presence of any of those compounds,
      causes a product to be considered to be a plant growth regulator (40 CFR 152.8(c)(l)
      & (2)).  However, products containing auxins, cytokinins, and gibberellins may be
      exempt from registration if the labeling meets the criteria for vitamin-hormone
      horticultural products (40 CFR 152.25(d)). Such exemptions are granted on a case-by-
      case basis. (See FIFRA Section 2 for definition of plant regulators).

      Soil amendments (eg. vermiculite, sand, lime, etc.) intended to increase porosity,
      retain moisture, adjust pH, and other uses intended to benefit crop production but
      which do not have claims or are not of a composition that would cause them to be
      classified as pesticides or plant regulators. An example: although normally considered
      to be a fungicide or miticide, sulfur, when applied to soil to adjust the pH would not be
      subject to registration. Note: Sulfur may also have non-pesticidal  uses as a foliar plant
      nutrient at low concentrations.  (40 CFR 152.8(c)(4)).

      Attractants intended for survey or census purposes only, and not intended for
      control or mitigation of the pest.  (40 CFR 152.10(c)).

      Deodorizers, bleaches, soaps, and other cleaning agents which do not bear claims
      for sanitizing or disinfecting properties. A bleach which consists of  5.25% sodium
      hypochlorite must be registered if the label states that bacteria will be killed at certain
      doses. An identical bleach would not need to be registered if the labeling does not
      contain a bactericidal claim even though it delivers the same benefits at  appropriate
      doses.

      Pheromones labeled for use only in pheromone traps, when the pheromone is the
      sole active ingredient (40 CFR 152.25(b)).  NOTE:  pheromones  are intra-species
      communicators.  Using fox urine  to repel rabbits  is not a pheromone.  It is an
      "allomone" and would be subject to FIFRA.
 Pesticides and Labeling
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 Label Review Manual
Current as of December 27,1996
 ซ•    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. So 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 is not required. Products sold as vase
 .   .   water additives for cut flowers bear special scrutiny. If they are composed, as many are,
       of simple sugars intended to supply nourishment to the cut flower, they are not under
       the purview of FIFRA. If, however, they are claimed to prevent bacterial or fungal
       growth hi the vase water, have plant regulator claims such as delays flower opening, or
       includes claims for control of stem rot, or decay, they are subject to FIFRA and must
       be registered.

 ซ•    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."
       Consequently, substances used in these processes for pesticidal purposes are regulated
       by FDA, not EPA. Drying, husking and shelling do not meet that definition so that
       pesticides used during these processes are regulated under FIFRA.  Cosmetics are
       Pharmaceuticals regulated by FDA.                              •

 State Labeling

       On some federal labels certain restrictions or special directions may pertain only to a
 certain state or set of states. When these requirements are not federally mandated, but required
 by the state, EPA may allow such restrictions on the label. For example, "State law prohibits
 the use of this product in sewage systems in the State of Connecticut." The statement should
 make it clear the restriction is due to a State law, not a Federal one. (Reference: LP94-20).
 However,  the label reviewer should know the provisions of FIFRA Section 24(b): "State(s)
, shall not impose or continue in effect any requirements for labeling or packaging in addition
 to or different from those required under this Act;" Therefore, review the state restrictions or
 directions to assure that they do not conflict with the requirements of FIFRA.
                    ^         . ,        .ซ   •      .         ' •   '",-•'    ,       '

 Special Local Needs

       Once a Special Local Need (state) FIFRA Section 24(c) supplemental label has been
 issued and not disapproved by EPA, it may be presented (displayed) along with the complete
 federal FIFRA Section 3 text  on the same product label (container or booklet).
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Label Review Manual
Current as of December 27,1996
      RD issued the Guidance Document on Special Local Needs State Registrations on
2/9/96 (Reference: MLD-22 and 4007.1). This Guidance Document requests states to submit
some new information such as a more detailed explanation of the special local need and a
statementofnoimreasonableadverseeffectsforunregisteredformulatioris. (Reference: LP96-
06) This document also provides guidance to reviewers and PM's/RAL's on how to process
label changes.
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Label Review Manual
Current as of December 27,1996
Chapters   GENERAL FORAIAT & LEGIBILITY REQUIREMENTS
Introduction                                                 •                   ,

      This chapter addresses "labels and labeling", the legibility requirements for draft
labeling, the sample label format and guidance concerning specific label requirements versus
preferred label requirements. The sample label format which appears at the end of this chapter
is designed to illustrate the arrangement of information which may or may not have a specific
location requirement on a pesticide label. (See 40 Code of Federal Regulations (CFR)
152.50(e), General Information on Applying for Registration of Pesticides in the United States
("Blue Book"), Second Edition, August 1992 (now available on the Internet on the EPA Home
PageatWWW.epa.gov or through NTIS, National Technical Information Service) for further
information).                                   -  ,

Definition of "Label" and "Labeling" {The Federal Insecticide. Fungicide, and Rodenticide Act
(FIFR A) Section 2fpYj

1.    LABEL: The term "label" means the written, printed, or graphic matter on, or attached
      to, the pesticide or device or anyof its containers or wrappers.         /
           - .                >      -             '.'-'••
2.    LABELING: The term "labeling" means all labels and all other written, printed, or
      graphic matter which:

      A.    accompanies the pesticide or device at any time; or

      B.    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,  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.

            For purposes of application for registration or amendment, copies of labeling
            should be submitted to the Agency on 8 W X H"paperormountedon81/4"xH"
 •  "  . •  "'  '  -paper./ •   •• -  '   '   '    . •  •  .    •'.•'.'.   ; .  : ..     '      , _  '  •
General Format & Legibility Requirements
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Label Review Manual
Current as of December 27,1996
3     MATERIAL SAFETY DATA SHEETS (MSDSs): The Agency does not have direct
      authority over MSDSs. However, when an MSDS is distributed with a pesticide it
      becomes a part of the pesticide labeling (7 U.S.C Section 136(p)(2)(A).  As part of a
      pesticide's labeling, a MSDS could render the pesticide misbranded if the MSDS gives
      the user warnings or precautions which conflict with the rest of the FIFRA-approved
      label. Nevertheless, the Occupational Safety and Health Administration (OSHA)
      retains full authority over MSDSs. (Reference: PR Notice 92-04).

      Although an MSDS which accompanies a pesticide product is labeling, EPA required
      statements cannot be placed directly on the MSDS because the Agency does not review
      orapproveMSDSs(Reference: LP95-07). However, statements which direct the reader
      to the product label for the correct personal protective equipment (PPE) requirements
      or other use precautions are acceptable (Reference: LP93-03).
                                                                ''
                Requirements
      The reviewer should only accept draft labeling for review that meets the following
requirements:                                                           ,

1.    The submission must include three copies of all draft labeling (typescript or mock-up).

2.    All three copies must be legible and of sufficient quality for photocopying.

•ar    If the labeling submitted by the registrant does not meet the above criteria, discontinue
      the label review.  Go to chapter four and five to open and close out the registration
      action.  Send a letter describing to the registrant the submission deficiencies.

Manual Requirements Vffl?1™ Manual Recommendations

      This manual contains labeling requirements (as required by FIFRA)i  and labeling
recommendations to achieve consistency among labels where appropriate. In this manual:

             the word "must" is used to note any items and/or actions spflfflfiffirtly required
             by F1FRA or the regulations or other EPA directive, e.g. PR Notices and

             the word "should" is used to identify any items and/or actions that, while not
             specifically required, ara preferred for the sake of increasing consistency and
             quality in the label review process.
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Label Review Manual
Current as of December 27,1996
      Reviewers using this manual must take note of the uses of "must" and "should"
throughout the manual. When responding to registrants concerning necessary label changes
and any other recommendations resulting from the label review, the reviewer must make certain
that required label changes are phrased as commands to the registrant.  Commanding verbs
such as "must be revised", "must be changed", or "must be moved" ate to be used in the
reviewer's response to the registrant. When responding to the registrant concerning preferred
but not required label changes, the reviewer must use verbs that are suggestive or instructional
such as, "should be revised", "should be changed" or "should be moved."  .

Label Format                                  .   -

      Listed below are the various portions or statements of the sample label format which
appears 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.

ซ*•    Ingredient Statement (Chapter 6)
      , This section identifies the active ingfedient(s), the percentage by weight of each active
      ingredient and the percentage by weight of inert ingredients in a pesticide product.
                                            • • '       " •   '             /   '

ซ•    Restricted Use Pesticide Statement (Chapter 7)
      This section identifies certain pesticide products, that without additional regulatory
      restrictions would have been found to cause unreasonable adverse effects on the
      environment, including injury to the applicator. These products have been classified as
      .Restricted Use Pesticides according to FIFRA Section 3(d).
                            "-       . -    .       ^       •          "
ซ•    "Keep Out of Reach of Children" (KOROC) Statement (Chapter 8)
      This specific statement which is commonly referred to as the KOROC statement ("child
      hazard warning") appears on almost all end use pesticide products except  those
      pesticides which are intended for use on children or where it is .demonstrated that
      children will not come in contact with the product. Inthese cases, amodified statement
      is required.

ซ*•    "Skull & Crossbones" Symbol & the word "POISON" (Chapter 8)
      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: acuteoral, acute
      dermal or acute inhalation or contains certain inerts.
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Label Review Manual
Current as of December 27,1996
      First Aid (Statement of Practical Treatment) (Chapter 8)
      This section provides information to the pesticide user concerning appropriate first aid
      for the various routes of exposure if accidental exposure occurs.
      Environmental Hazards (Chapter 9)
      This section identifies any hazards to the environment and any necessary precautions
      to protect the environment.            )  •
      Physical or Chemical Hazards (Chapter 10)
      This section identifies any hazards such as flammability, explosibility or dielectric
      breakdown.                         .
      Directions for Use (Chapter 11)
                                                          t ,
      This section provides the instructions concerning how to use the product, the pests
      treated, the application sites, and any application equipment to be used.
                                          ••'.•'    .        •      i . •
      Re-entry Statement (Chapter 11)
      This section identifies any time period following treatment when entry into a treated
      area is restricted.
      Product Name (Chapter 12)
      Warranty Statement (Chapter 12)
      This is a disclaimer statement included voluntarily on most pesticide products by the
      registrant regarding the company's liability.
      Storage and Disposal (Chapter 13)
      This section identifies the precautions necessary for storing the pesticide product and
      disposing of both any unused pesticide and the pesticide container.
      Registrant Name & Address (Chapter 15)
      Net Contents (Chapter 16)
      This section identifies the amount/weight of pesticide in the container.
General Format & Legibility Requirements
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 Label Review Manual
Current as of December 27,1996
 ซ•    EPA Registration Number & Establishment Number (Chapter 17)

      This section identifies the company number and product number assigned to the
      pesticide product and the establishment number which identifies where the pesticide
      product was produced. Chapter 17 also covers Supplemental Distribution labeling.

 Final Printed Labels

      The type size of final printed labels may be checked by using the following template.
 This is accomplished simply by overlaying the template  on  the final printed label and
 comparing 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. Use the table at the top of the chart
 to determine the appropriate type size based on the size of the label.

 [The following page is the template, which could be printed on a transparency for use.]
General Format & Legibility Requirements
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Label Review Manual
                                              Current as of December 27,1996
                     Label Type Point Chart
Size of Label on Front
Panel in Square Inches "
5 and under
above 5 up to 10
above 10 up to 15
above 15 up to 30
over 30
Signal Word as Required
Minimum Type Size All Capitals
6 point
10 point
12 point
14 point
18 point
, "Kee}> Out of Reach
&fi*pi&E ;<~ -x ;
6 point
6 point
8 point
10 point
12 point
18 point
12 point
12 point

14 point
10 point
10 point

12 point
8 point
8 point

10 point
6 point
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6 POUlt
         POISON   DANGER  WARNING  CAUTION
                KEEP OUT OF REACH OF CHILDREN
                    Keep Out of Reach of Children


         POISON   DANGER  WARNING  CAUTION
                   KEEP OUT OF REACH OF CHILDREN
                       Keep Out of Reach of Children

             POISON  DANGER WARNING  CAUTION
                       KEEP OUT OF REACH OF CHILDREN
                         Keep Out of Reach of Children
                                           I!     .':.•*:
                 POISON  DANGER WARNING CAUTION
                          KEEP OUT OF REACH OF CHILDREN
                            Kปep Out of Roach of Children

                         POISON DANGER WARNING CAUTION
                          KEEP OUT OF REACH OF CHILDREN
                            K*^ Out ฐ* Rปซreh of Children
General Format & Legibility Requirements
                                                                   Page 3-6

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-------
 Label Review Manual
                        Current as of December 27,1996
 Chapter 4
TYPES OF LABEL REVIEWS
 Introduction                                  ,

       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 aresubmission (follow-
 up to a previous submission).

       This chapter focuses on only those submissions that involve a label review and the
 specific "action  codes" assigned to each of these submissions.  Action codes have been
 developed for use in the "Pesticide Regulatory Action Tracking System" (PRATS). See chapter
 5 for further details.

       When a registrant submits several product registrations together that are in effect a
 series of dilutions (products that have the same active and inert ingredients so when diluted
 they are identical), every effort should be made to route and review these submissions together
 to ensure consistency of labeling decisions.

 Submissions That Do Not Involve Label Review

       All label reviewers should be familiar with these types of submissions as they can affect
 future label review of a given product.  These three types of submissions are discussed below:

 1.     SUPPLEMENTAL DISTRIBUTOR LABELING (Private labels): After a registrant
       has obtained final registration for the basic product, the second company may then
       supplementally distribute or sell his/her product by agreement with the registrant 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. It is the responsibility of the basic registrant to see that all
       distributor labeling is kept in compliance with requirements placed on the basic product.
       The basic registrant should notify EPA  if it terminates its agreement with a
       supplemental distributor. Supplemental distributor labels should not be submitted to
       EPA for review. If submitted they should not be stamped Accepted, or retained in
       Agency files (See chapter 17 for more information on distributor labeling).
Types of Label Reviews
                                               Page 4-1

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Label Review Manual
Current as of December 27,1996
2.    25b EXEMPTIONS: The Agency does not require submission or review labels for
      pesticide products which meet the conditions for exemption under 25(b).  The 25(b)
      exemption rule, published March 6, 1996 (Volume 61, Number 45, pp 8876-8879),
      clearly indicates the conditions  of exemption  and the requirements to meet the
      exemption.   The  Agency's  false and  misleading labeling requirements (CFR
      156 10(a)(5)(i) through (viii) and the periodically updated List 4A (Inerts of ininimal
      concern) inerts list, originally published inFfldfTfri Register (FR) Volume 54, Number
      224, November 21,1989 and PR Notice 90-1, go into additional detail as to what is
      exempted.  Call Bob Brennis at 703-305-7501 if you have any questions about this
      policy.

3.    NOTIFICATIONS: 40 CFR 152.46 and PR Notice 95-2 allow registrants to make
      minor modifications to their registration (label) that have no  potential to cause
      unreasonable adverse effects to the environment.  Such changes are submitted via
      "Notification";  an Application for Registration form (EPA Form 8570-1) marked
      "Notification" submitted to the Document Processing Desk. Notifications are processed
      separately. The following modifications can be made by Notification:
                                                i • .  i'''     '    .  • '       "     ' •, ,
                                             .•1    '      "     • '    ",    .     • •
              •  Adding alternate brand names
                Adding and deleting pests (except public health pests and termites)
                Adding indoor, nonfood sites for antimicrobial  products
                Adding, revising or deleting advisory statements (except for Groundwater
                 Advisory Statements)
                Changes in packaging and related labeling statements
                Use deletions related to Data Call-ins
                Storage and disposal statements
                Bilingual labeling
                Use of symbols and graphics
                Redundant labeling statements
                Changes in Warranty Statements
                Other revisions (minor  label changes related to the Federal Insecticide,
                Fungicide and Rodenticide Act (FIFRA))

             Refer to PR Notice 95-2 for the details on Notifications. It contains also a list
             of changes that are non-notifications; that is, changes the registrant can just
             make without notifying the Agency. OtherPRNoticesmaypermitmodification
             by notification.
 Types of Label Reviews
                        Page 4-2

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Label Review Manual
Current as of December 27,1996
 Submissions Requiring Label Review

       1. Old Chemical, Without Data
       2. Old Chemical, With Data
       3. New Chemical
       4. Technical Products and Manufacturing Use Products
       5. Special Local Needs
       6. Experimental Use Permits

 1.     OLD CHEMICAL, WITHOUT DATA (ME-TOO/FAST TRACK): This type of
       subinissionrnvolvesanoldcheinical(act^
       as a pesticide, and with the current submission, "nothing new" is being proposed for the
       chemical or formulation. Such submissions are referred to as "me-too" submissions.
       They may either be amendments to labels of existing product registrations, or they may
       be applications for new product registrations. An example of such a submission is an
       amendment for the addition to the label of a new site or pest which has been accepted
       previously on labels of other products containing the chemical.  Therefore, "nothing
       new" has been proposed for the chemical.  For products composed of multiple active
       ingredients; the proposed addition must not be new to any of the a.i.'s.

       ซ•     If nothing new is being proposed for the chemical,  no additional data
             submissions are usually required, although data citations may be required (see
       ' • ,  40 CFR 152.80 through 152.97). If eligible for formulator's exemption data
             citation is not required. For example, when a crop is added to a label and it is
             ame-too submission., data must still be cited because residue data were originally
             required to register the use on the crop. Citation of data protects the rights of
             data submitter(s) by acknowledging  the studies  and offering to pay the
             submitters compensation for the cost of generating the data. If the submission
             is eligible for the Formulator's Exemption, data citation(s) are not required.

'••'ซ•     Withame-toosubmission,thesubjectproductmustbeidenticalorsubstantially
             similar in uses and formulation to a currently registered  pesticide, which the
             applicant must cite by the EPA registration number. The re viewer must ensure
             that the two products are substantially similar or identical in formulation. To
             make this determination, refer to the following guidance:
Types of Label Reviews
                       Page 4-3

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Label Review Manual
                                     Current as of December 27,1996
             a.
             b.
             c.
             d.
  Guidance for Determining Whether Acute Tox Data
    from One Product Will Support Another Product

      If the pending product is identical to the cited product* it's
      acceptable.

      If the pending product is almost identical to the cited product, for       .
      example the only difference is that a minor inert component
      (<1%) is replaced by 2 components doing the same function, each
      at half the percentage, it's OK.             ,

      If the pending product is essentially a dilution of the cited product
      with water and the cited product is in category III or IV for all
      acute toxitity endpoints, it's OK.
                                   ' ,"' '  '   '     ^ i    •       '     l
      If the pending product is essentially a dilution ofthe cited product
      and there is a Category I or II endpoint for one or more acute
      toxicity endpoints, route for precautionary review.

      If the pending product has the same active ingredient in the same
      percentage, but different inert ingredients performing the same
      functions in approximately the same percentages, send it for
      precautionary review.

NOTE:  Check the pH of the two products. Sometimes they are widely
different This can affect uritancy and even oral toxicity.  If the products
look alike, but have widely different pH's, we are due an explanation. If
they are not close to identical, this is a signal that the products are not
similar.

The label reviewer must also assure that the use patterns are similar.  In
addition, if the label under review is a rodenticide or repellent^ any changes in
the inert ingredients should be cleared by the efficacy reviewers to make certain
that the inert changes will not affect the efficacy of the product, (i.e., change of
bait color, smell, texture, etc.).

The registrant must submit complete product chemistry data for technical
products, and Manufacturing Use Products (MPs) and End-use Products (EPs)
that are produced by integrated systems. The product chemistry data should be
             e.
 Types of Label Reviews
                                                             Page 44

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Label Review Manual
                                                  Current as of December 27,1996
2.
             sentforproductcheroistryreview. Theproductchemistryreviewerwill compare
             the concentrations of the same active ingredients and its associated impurities to
             determine substantial  similarity in accordance with Standard  Operating
             Procedure (Reference: SOP 3068.2).

       •*    For aUEPs that are formulated with a registered source product and are foiind
             to be toxicologically similar, product chemistry data are required in accordance
             with 40 CFR 158.150 through 158.190, and should be reviewed by product
             chemistryfor adequacy, completeness and validity of the data,

       ซ    If the product involves a me-too product that is found to be toxicologically
             dissimilar to the cited product when it is run through the guidance, then the
             label review process is ended. The reviewer should prepare correspondence to
             the registrant noting that the Agency has determined that the cited registered
           .  product is not substantially similar and that the registrant must submit acute
             toxicitystudies(revisซPRATScode).'Thereviewershouldthenassigntheaction
             code from this chapter (listed later in the chapter) and proceed to chapter 5 for
             instructions on how to open and close the entry into PRATS.

       ซv    If the me-too product is a "repack" (i.e., the product is simply repackaged and
             nothing changes) or an identical formulation, check the Confidential Statement
             of Formula (CSF) with the  CSF of the cited product to make certain the
             formulations are the same. No data are required.

       OLD CHEMICAL WITH DATA (NON-FAST TRACK): This type of submission
       involves an old chemical where "something new" is being proposed.  For example, the
       proposal may involve an amendment or a registration with a new use, a new application
       rate, or a change in Precautionary statements. Basically, it is an action not previously
       approved by the Agency. Therefore, a more extensive review 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 other divisions (Health Effects Division (HED), Ecological Effects and
       Environmental Fate and Groundwater Division (EEEFGD), Biological & Economic
       Analysis Division (BEAD)) or from the product chemists, toxicologists, or efficacy
       reviewers in the  appropriate division.  Generally a review from the other divisions
       (branches) will only affect a small portion of the label; the rest of the text should remain
       unchanged from the originally accepted label.
Types of Label Reviews
                                                                         Page 4-5

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Label Review Manual
                                           Current as of December 27,1996
3.
NEW CHEMICAL (NEW LABEL): This type of submission involves a new chemical
(a.i.) which has never been registered by the Agency as a pesticide. It is up to the
registrant to propose the labeling for the new chemical;  OPP does not develop the
label. The labeling should, however, follow the general label format discussed in
chapter 3. The text is then referenced against the reviews from the other divisions who
should have received a copy of the proposed label in the package sent to them for
      review.
      TECHNICAL PRODUCTS AND MANUFACTURING USE PRODUCTS: This
      type of submission involves a formulation which is used in the manufacture of other
      pesticides, either end-use products or other manufacturing use products. A technical
      product should be registered before any other manufacturing use products or end use
      products can be formulated from it and'registered.  If the technical product is not
      intended to be registered, the data submissions for the MP and/or EP must include all
      the, product chemistry data for that technical  as required in the 40 CFR  158.150
      through 158.190. However, a technical/manufacturing use product (MP), in the case
      of a new a.i., must not be registered unless there is an end-use formulation also pending
      with the Agency. (Reference: PR Notice 87-7 (PR-87-07))
                                                .!;..:•      .: : ' ,     .
      ซr    A technical product is always itself a MP, however, not all MPs are technical
             products. The technical product contains only the a.i. with no impurities other
             thanthosethatnraylravebeenmtroduceddurmgthem
             contains no intentionally added inert ingredient other than those used to purify
             the a.i..
                                                 "r ' •  '•'!•,      '   '         •; ' . "  • •'
      ซr    Again, thelabeling of the technical/manufacturing useproductmustfit the basic
             label format, but will also include a statement such as "For Manufacturing Use
             Only" and a listing of the application sites for EPs.

      SPECIAL LOCAL NEED (SLN) - FTFRA Section 24(c): This is a submission under
      the states' authority under FIFRA section 24(c) to register additional usesof afederally
      registered pesticide.  These additional uses are for distribution and use 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
      crop grown within a state may be attacked by a particularly damaging pest, or state
      officials may expect it to be attacked sometime during the growing season, thereby
      creating a special pest problem. The pesticide (a.L) must have an established tolerance
      associated with the crop, or be exempt from the requirement of a tolerance for that
Types of Label Reviews
                                                                   Page 4-6

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 Label Review Manual
Current as of December 27,1996
       crop. SLIsPs also may pertain to uses for control of pests peculiar to one or several
       states.                   ,

       Special Local Need labels are not stamped "Accepted", but they are reviewed for the
       required, pertinent information.  Like Section 3 labels, Section 24c labels may also be
       "split." A split label isa limited version of the full label and contains only some of the
       uses which are listed on the original. Split labels are sometimes referred to as "specialty"
       labels or "separation of uses" labels. The State is sent a letter acknowledging receipt of
   .   .the application. If there is a problem with the SLN, (e.g. no established tolerance) a
       disapproval letter is sent. 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 ,
       HED for their review (e.g., if there is a question on the associated tolerance). In such
       cases, HED will review the label  and make recommendations.

 6.     EXPERIMENTAL USE PERMITS: Experimental Use Permits(EUP), are required
       for authorizing extensive field trials (greater than ten (10) acres terrestrial; one acre
       aquatic) of unregistered pesticides or registered pesticides used per site at sites not
       claimed on the accepted registered labels. The EUP label will follow the standard label
       format, except that the front panel will include the statement "For Experimental Use
       Only." Biological pesticides have different allowances depending on the a.L, e.g., certain
       pheromone products have a 250 acre threshold before an EUP is required.

 Determining Action Code                          '

       Select the appropriate action code from the list below based on the submission type
 identified, and proceed to chapter 5 for  details on entering the action into PRATS.

       Old Chemical Without Data:

       160 - an application for a new registration of an old chemical that is a routine me-too.
       Resubmission:  161.

       170 - a me-too application for registration of an old chemical, with an additional use.
      Resubmission: 171.
Types of Label Reviews
                       Page 4-7

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Label Review Manual
Current as of December 27,1996
      300 - an amendment submitted to revise an existing label, may not necessarily be a me-
      too action, but will not require any input (reviews) from other branches.
      Resubmission: 301.

      310 - an amendment to add a me-too use to an existing registration.
      Resubmission: 311.

      Old Chemical With Data:

      165 - application for registration of an old chemical .with minor changes requiring
      review from other divisions.
      Resubmission: 166.                .

      175 - application for registration of an old chemical with a new non-food or non-feed
      use, requiring review from other divisions.
      Resubmission: 176

      180 - application for registration of an old chemical, first new food or feed use.
      Resubmission: 181.

      305 - label revision amendment with data required, Divisional review only.
      Resubmission: 306.

      320 - label revision amendment with data requiring HED, EEEFGD review.
      Resubmission:  321.                      ,

      325 - me-too label revision amendment with data requiring HED, EEEFGD review.
             Resubmission: 326.         ..

      370 - amendment to an existing registration adding a first food or feed use.
      Resubmission: 371.

       360 - action initiated by Agency
      Resubmission: 361

       655 - label submission resulting from a Reregistration action, e.g. a data call-in.
       Resubmission: 656.
 Types of Label Reviews
                        Page 4-8

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Label Review Manual
Current as of December 27,1996
      674 - 8-month response to RED in support of Reregistration.
      Resubmission: 675.

      New Chemical:

      100 - application for the registration of a new chemical, food or feed use.
      Resubmission: 101

      115 - application for the registration of a new chemical, nonfood or nonfeed use.
      Resubmission: 116

      130-application for registration of a new biological, food or feed use.
      Resubmission: 131.

      145 - application for registration of a new biological, nonfood or nonfeed use.
      Resubmission: 146.

      Special Local Need:

      580 - assigned to a 24(c) application for a food or feed use.
      Resubmission: 581.

      582 - an amendment to an existing food or feed SLN.
      Resubmission: 583.                  .

      585 - assigned to a 24(c) application for a nonfood or nonfeed use.
      Resubmission: 586.

      587 - for an amendment to an existing nonfood/nonfeed SLN.
      Resubmission: 588.

      Experimental Use Permits:

      700 - EUP for a new chemical, nonfood or nonfeed use.
      Resubmission: 701. Amendment: 704, resubmission of the amendment: 705.

      710 - EUP for a new chemical, food or feed use.
      Resubmission: 711. Amendment: 714, resubmission of the amendment: 715.
Types of Label Reviews
                      Page 4-9

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Label Review Manual
Current as of December 27,1996
      720 - EUP for a new biological, nonfood or nonfeed use.
      Resubmission: 721. Amendment: 724, resubmission of the amendment: 725.

      730 - EUP for a new biological, food or feed use.
      Resubmission: 731. Amendment: 734, resubmission of the amendment: 735.

      740 - EUP for an old chemical, nonfood or nonfeed use.
      Resubmission: 741. Amendment: 744, resubmission of the amendment: 745.

      750-EUPforanoldchemical, food or feed use. Resubmission: 751. Amendment: 754,
      resubmission of the amendment: 755.

P| esiihmissions  ,
              11 . .    "'    '     •    ••.'''     ..('I'; . "h \": '   "•  "';";;"'   •• "' " '.-..•,':.'.• •
      Resubmissions are foUow-up actions from registrants responding to objections wehad
to their original submissions due to data or labeling deficiencies. The entire label of the subject
product should be re-reviewed with particular care to ensure that the registrant has answered
all of the concerns we had expressed during the original review.  The label reviewer should
make sure that all the necessary revisions and corrections have been made to the label and that
nothing else has been added to the label. It is not uncommon for registrants to fail to comply
with all of revisions required,  either inadvertently or because of disagreement.  Note that
^submitted actions are assigned PRATS action codes that chronologically follow the action
code assigned to the initial submission. Resubmissions may occur 2, 3, 4+ times after the
original submission before theregistrant'-getsitright." There is, however, only one action code
for every resubmission of a particular action, no matter how many times it is used. For
example, 161 would be used over and over, as a follow-up to a 160.

Determining  the Scope of Registration

      The term "Scope of Registration" is defined as the complete profile of accepted labeled
uses for given product. The term "Master Label" is defined as a label that contains all accepted
uses for a given product. The term "Sub-Label" is defined as a label that contains only a
portion of the accepted uses for a give product.                    .

       Labeling use patterns are captured by 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
scope of registration for a given product. LUIS captures sites, application methods (type,
timing, and equipment), application rates, frequency  of application, maximum number of
applications, treatment intervals, and limitations (e.g., preharvest intervals, reentry intervals)
 Types of Label Reviews
                       Page 4-10

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 Label Review Manual
Current as of December 27, 1996
 from approved Section 3 and Section 24c labels. It is critical for LUIS extractors to be able to
 assemble the complete scope of registration for each product. The aggregated use pattern
 defined by LUIS is the basis for risk analysis in reregistration.  Eventually LUIS will be used
 for both risk and benefit analyses in Special Review, Conditional Registration, tolerance
 assessments, etc.. If LUIS is incomplete then the risk analysis will be likewise. The consequence
 can be either poor registration decisions or needless hours of OPJ? rework to correct errors
 which may be later pointed out by the registrants.

       Over time, product labels are changed by the amendment or notification process.
 Crops/sites are added and deleted.  Often this is accomplished through the submission of
 amended supplemental labels, and recently, by notification as per PR Notice 95-2 which now
 allows changes that can affect the scope of registration.  These types of partial label
 submissions are acceptable  and even desirable because they speed up the review process
 (reviewer does not have to review the entire label) and cut down on waste (papers copies of
 entire labels do not have to be submitted every time an amendment is made). However, this
 process makes it more difficult to determine the scope of registration for a given product.
 Therefore, labels that  do  not contain the entire use profile for the product should
 clearly indicate so. Registrants should indicate at the top of the label that it is a Sub-
 Label and if necessary, indicate what kind, ie, split label, supplemental label, etc... and
 should also include  a reference to the master label and its last accepted date.  For
 example:                                   ^

      SUB LABEL (Supplemental)  - Revises master label dated XXXXX

      After a period  of time, when the regulatory file has several of these sub-labels, the
 registrant should be notified to submit a new "Master Label" containing all the accepted uses
 of the product registration. It is up to the discretion of the reviewer as to how often a master
 label should be requested.'
         • . • i  •       •  .   •     '      •       .                     "•••..  :
 Memorandum of Understanding with California

      A Memorandum of Understanding (MOU) exists with California's Department of
 Pesticide Regulation (DPR) to allow Cal DPR to review data to determine the toxicity and to
 determine if the data supports the registration.  Precautionary reviewers are the primary group
 in RD working with California on this MOU. California is primarily reviewing studies for new
 products (me-too's) that will be registered in California.  (Reference: LP94-24)
Types of Label Reviews
                     Page 4-11

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 Labef Review Manual
                 Current as of December 27, 1996
 Chapter 5
PRATS ENTRY
 Introduction  .                                               .

       Any product regulatory action (primary submission or resubmission) should be entered
 into the "Pesticide Regulatory Action Tracking System" (PRATS) as soon as it is received on
 the team. This process enables OPP to track activity on a product; since each action is dated,
 a history of a product's registration or a tolerance petition is composed. This information is
 then easily retrieved, as well as monitored for our response. Thefollowing outline provides the
 details for the PRATS entry of a submission (or a resubmission) requiring a label review. The
 "PRATSUsers Guide" should be referred to for further information.

 Logging in the PRATS Entry

 1.     PRATS ACCESS: PRATS may only be accessed through the LAN system, therefore,
       beforeanything else, you must be logged into LAN.  From the "OPP File Server Main
       Menu," make the following selections: .     >
             F3 OPP Applications H
             Fl PRAT
             Fl PRAT Pesticide Regulatory Action Tracking

       From these selections, the "Title Screen" will appear. Press "Escape" to go to the
       "PR AT Main Menu." The product's file in PRAT may then be accessed byentering the
       Registration Number, File Symbol, or Experimental Use Permit (EUP) number. (A file
       Symbol is issued for an unregistered product - see chapter 17 regarding file symbols).

2.     SUBMISSION TYPE: Chapter 4 of this manual provides information for determining
      the type of submission or action that you are dealing with.  Once this has  been
      determined, an action code can be assigned to the submission. Three types of actions
      will involve label reviews: a submission for a product already registered, a resubmission
      which is responding to Agency concerns or questions from a previous submission, or
      an application for a new registration.

3.    SUBMISSION ENTRY: Once the product file has been accessed, a screen will appear
      showing the "Case Information" in the upper half of the screen (the product name, niain.
      active ingredient, PM/team leader assignment, etc.), and the "Submission Information"
PRATS Entry
                                       Page 5-1

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Label Review Manual
                                                Current as of December 27,1996
      in the bottom half of the screen. Press "Escape" for the following choices at the bottom
      of the screen (the menu):
           *                        „   *            '"              .,,'.,
            Edit Case, New Subm., Add Resub., Case Ref., Select., Main Menu

            Highlight "New Subm.," or "Add Resub.," by using the right or left arrow key
            and pressing Enter, or by pressing "N" or "A" (the first letter of your choice).
            PRATS will now ask you to fill in the blanks for the "Submission Inprocessing
            Information:"
                   A.    The submission Bar Code is already assigned.

                   B.    Select the team reviewer by using the up or down arrow key in the
                         team window, and pressing Enter.

                   C.    Enter the action code determined in chapter 4 by pressing the
                         appropriate number keys. PRATS will respond with an Action
                         Code window. Double-check the action code and its descriptor,
                         then press Enter. Note: if you decide the  action code is not
                         appropriate, PRATS will let you scroll up or down and look at
                         other action codes.

                   D.    Enter the dates for "Applied" (date on the Registrant's application
                         or cover letter), "Received" (pin punch date) and "PM Received"
                         (when the team received the action.

                   E.    "Related ID's" may  be entered if desired.  These  refer to
                         Registration Numbers of Me-Too products or other related
                         products. This field may be skipped by pressing Enter.
                                          '  , •   !!' ,i'      • • ' •     •   '   . , , ,"    '   .
                   F.    Add a descriptor - briefly (limited space) indicating what the
                         submission is about.  This field is also not required, but strongly
                         recommended! The descriptor can be very helpful when scrolling
                         through thePRATS submissions of a product, particularly if that
                         product has been very active and has many entries.   Each
                         submission may be highlighted and the descriptor will appear at
                         the bottom of the screen.

                 .  G.    Press Enter twice, the second time will save the information.

                                                                         Page 5-2
PRATS Entry

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Label Review Manual
Current as of December 27, 1996
                  This entry will now appear as part of the regulatory "history" for this
                  product in the entry listing entitled "Submission Information."

      RESUBMISSIONS: If the action has been designated as a resubmission - representing
      a response by the Registrant to an Agency concern or question from a previous
      submission, it must be tied to orconnected with the original action. More simply, if the
      Registrant applied for a label amendment and we turned them down or rejected the
      application, a resubmission may be the Registrant's attempt to "fix" whatever was
      wrong with the original submission.

      When entering a resubmission into PRATS, you must identify the original submission.
      PRATS will ask for the original submission by showing a window with all primary
      action information. The appropriate choice is made by highlighting the item with the
      up or down arrow key, and pressing Enter. Once the choice is made, PRATS will
      automatically assign the action code. This code is designed to chronologically follow
      the primary action code, i,e., 160; 161 for the resubmission(s).
                 , -   '    • '      •      :  '   '•      '    ~    * '  .        S    ."
                        Tip on REPEAT feature of PRATS

            If you have two or more actions (for example, new applications or amendments)
            that have the same application date, received date, action code, and action
            description, you need not enter each action separately into PRATS. After
            entering the first action, hit "R" for "REPEAT", which is found at the bottom
            of the screen, instead of "M"  for "MAIN MENU."  Then  enter the next
            registration number or file symbol and, for amendments, the original action.
            After saving the initial action, note the new Submission Bar Code for the second
            action. Continue to use the REPEAT (R) function until you have entered all of
            the related actions.       , .... .

      NEW REGISTRATIONS: If the submission is an application for a new registration,
      PRATS will not let you add the primary submission until the Case Information section
      is complete.  The Front End Processing Unit (FEPU) has set up the basic product
      information,  but PRATS will force  you to first complete the "Active Product
      Chemistry" section; FEPU does not do this. Press "Escape" to access the menu, then
      "Edit Case."  After verifying the company number press "Page Down" to the Active
      Product Chemistry section. The active ingredient must be entered, either by Product
      Chemistry (PC) Code or name. Then the percentage concentration (label claim) must
      be entered. This process must be repeated for each active ingredient. Pressing Escape
      twice will save this information and exit you back to the Submission Information.
PRATS Entry
                      Page 5-3

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 Label Review Manual
  Current as of December 27,1996
             The reviewer should note that the information in this chapter does not include
             submissions which must be sent for review to HED, Ecological Effects and
             Environmental Fate and Groundwater Division (EEEFGD) or other Branches
             in the Divisions.  Sending a submission on for review requires the creation of a
             "Bean Sheet." Please refer to the PRATS User Guide for information on
             creating bean sheets. Reviews from other groups may ormay not affect product
             labeling.
Completion of Review
       When a label review is completed, the product file is again accessed through the PRATS
Main Menu via the Registration Number. Once the action to be logged out is highlighted,
press Enter and options will appear at the bottom of the screen. Choose "Edit Submission,"
then "Outprocessing." The "Submission Coprocessing Information" section will request the
following information:    ,
       Correspondence Date:	Response Date:
       75 Day _  Due Back:  /  /
       Comm:    	:	;	
/ /  Response Code:	
      The Response Code and Date are required fields. Answer "Y" (yes) to 75 Days	if
you want the Registrant to respond within 75 days, the date this response is due back will be
automatically entered. This field is not required, you may answer "N" for no, and press enter
to skip the Due Back	space.  As with the incoming submission,, a descriptor under
"Comments" for the response is very helpful. The comment will appear at the bottom of the
screen when the product file is accessed and the submission is highlighted.

      The following are the response codes that may be used when alabd, review is completed
(these are not all the response codes used when responding to submissions.):
      "11"    Objection - Data Deficiency. A data deficiency will affect a label review if
      supporting data was necessary for the proposed action and was either absent or
      deficient.
      "12"  Objection - Label Deficiency. Any type of problem with label text which would
      cause the proposed action to be denied should be logged out of PRATS with this code.
      "13"   Objection - A combination of both data and label deficiencies.

      "17"   Proposed new product or amendment to a label is acceptable, no conditions
      associated with the acceptance.
PRATS Entry
                         Page

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  Labef Review Manual
Current as of December 27, 1996
        "18"   Registration of a new product or an accepted amendment that are subject to
        conditions.

        The reviewer should note that when a 17 or 18 response code is used, PRATS will
 request answers to five questions; 1 j what the method of data support is (cite-all, selective or
 not applicable); 2) whether the product is in child-resistant packaging; 3) whether it is a
 restricted use product or not; 4) whether it is  an exclusive use; and 5) whether it is a
 manufacturing use or not. The reviewer should use a response code other than 38 (General
 Correspondence), if appropriate.
?RATS Entry
                     Page 5-5

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 Label Review Manual
                        Current as of December 27, 1996
 Chapter 6
INGREDIENT STATEMENT
Introduction              ,                                   •         •

       This chapter covers the ingredient statement section of the label, which must bear the
name(s) and percentage(s) by weight of each active ingredient (aj.) and the total percentage
weight of all inert ingredients (including any impurities associated with the active ingredient).
                         '••                        •
General Requirements

       Review the proposed. label for a clear and prominent ingredient statement which
contains the name and percentage by weight of each active ingredient and the total percentage
by weight of all inert ingredients.

       The definition of Active fngnedientis: Any substance that will prevent, destroy, repel,
or mitigate any pest, or that functions as a plant regulator, desiccant,defoliant, synergist or
nitrogen stabilizer. The definition of Inert Ingredient is: Any substance other than an active
ingredient which is intentionally added to a pesticide product, such as solvents, stabilizers,
spreaders or stickers, preservatives, surfactants, def earners, etc. Inert ingredients do not
include contaminants or impurities;, although for label purposes these are included in the inert
declaration percentage.                                                   -
               '             >       ''         '           ^
      The label's ingredients statement includes not only the percentages of active and inert
ingredients,  but also, if applicable, associated acid or metallic equivalents.  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.

      Follow through each section below as you review the proposed label:
            f the Tnrdient Statement
1.    THE INGREDIENT STATEMENT MUST CONTAIN:

      A.  The headings "ACTIVE INGREDIENT" and "INERT INGREDIENT" (or
          plural forms of these terms when appropriate), must be the same type size, aligned
          to the same left margin and equally prominent.
Ingredient Statement
                                              Page 6-1

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Label Review Manual
                                         Current as of December 27, 1996
2.


3.

4.
B. The name and percentage by weight of each active ingredient must be placed under
   the ACTIVE INGREDIENT heading and the total percentage by weight of all
   inert ingredients must be placed under the heading INERT INGREDIENT.

C. The percentages must be aligned by the decimal.

THE INGREDIENT STATEMENT MUST BE PRESENTED clearly, and be neither
obscured nor crowded by surrounding text.

PERCENTAGES cannot be expressed in a range of values, such as "20-25%."

SEVERAL EXAMPLES of correct ingredient statements are shown in this chapter.
Location of Ingredient Statement

1.     FRONT.PANEL: The ingredient statement is required on the front panel of the
      label.  However, if the pesticide package is extremely small or is irregular in shape
      making it difficult to place the ingredient statement on the front panel of the label,
      permission may be granted,  upon written request (this could be a part of the
      application), for the ingredient statement to appear on the back or side panel of the
      label.  See 40 Code of Federal Regulations (CFR) 156.10(g)(2)(i).

2.     LOCATION ON FRONT PANEL: The preferred location is immediately below the
      product name.  (Refer to the sample label format in chapter  3) For consumer, or
      residential products, the preferred location is after the front panel hazard warnings.

3.     OUTSIDEWRAPPERS: Ifthereisanoutsidecontainerorwrapperthroughwhichthe
      ingredient statement cannot be clearly read, the ingredient statement must also appear
      on the outside container or wrapper.

4.     PROMINENCE OF TEXT: The text of the ingredients statement must run parallel
      with, and be clearly distinguished from other text on the panel and must not be placed
      in the  body of other text. (40 CFR 156.10(g)).

Names To Be TTsed Tn The Ingredient Statement
                                            ' • ' l:      • '      •
      Review the names used, on the proposed label under the ingredient statement. Check
these names in the Reference Files System (REFS) on the LAN. If none of the names are
shown in REFS, perhaps you have a new chemical.  If so, check with your PM/team leader for
Ingredient Statement
                                                               Page 6-2

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 Label Review Manual
Current as of December 27,1996
 the correct procedures. Look at each section below to determine the correct names to be used
 in the ingredient statement.

 1.     COMMON NAME:

       A. Common names established by the American National Standards Institute (ANSI)
          are accepted by the Administrator, under the Federal Insecticide, Fungicide, and
          Rodenticide Act (FIFRA) Section 25(c)(6). If the common name has been accepted
          by ANSI, it may appear alone m the ingredients statement if it is well known. If the
          common name is not well known, it must be used in conjunction with the proper
          chemical name.                                                    .

       B.  Check REFS to determine the accepted common name. "(ANSI)" will be shown
          after the accepted common name in the Chemical Name list. An additional source
          for this information  is the EPA Manual, Acceptable  Common Names and
          Chemical Names for the Ingredient Statement on Pesticide Labels, 4th edition
          (December 1979).

       C.  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 (40
          CFRCh.l,Page608(7-l-95Edition)). Sincethisonlyincludesnamesforchemicals
          with tolerances, it is only a secondary source.

 2.    CHEMICAL NAME:

      A.  If there is not an accepted common name, the full chemical name must be vised. If
          there is an accepted common name, but it is not well known, the full chemical name
          must immediately follow the common name  on the  line under the ACTIVE
          INGREDIENT heading. For example:

                  Acephate (0,S-dimethyl acetyl-phosphoramidothioate)

      B.  If there is no accepted common name, the chemical name alone must be used.
                                              •           ,  ,                   |

      C.  Chemical names must be given accordingto the nomenclature used in the Chemical
          Abstracts (CA) Chemical Substance Index, published by the American Chemical
          Society. REFS reflects the correct chemical name: the entry found with the "9CI"
          (i.e., Ninth Collective Index) designation atthe end of the name. [REFS tip: hit the
Ingredient Statement
                      Page 6-3

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Label Review Manual
                                         Current as of December 27,1996
         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.]

3.     BIOLOGICAL NAME: If the active ingredient is a microbial agent, the microbial agent
      must be identified by genus, species and strain (if there is one). Again, this name must
      be identical to the name shown in REFS.

4.     DESCRIPTIVE.NAME: Descriptive names, approved by the Agency are to 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.

5.     WHAT IS NOT ACCEPTABLE: Trademark or proprietary names may not be used
      in the ingredient statement unless such names have been acceptedas a common name
      by the  Administrator under the authority of F1FRA Section 25(c)(6). Trademark
      names  and other information concerning a particular ingredient may appear by
      reference in a footnote to the ingredient statement

Oiteria for Active or Inert Status and Related Compounds
 1.
 2.
DEFINITION OF ACTIVE/INERT INGREDIENT: The criteria for ingredients
determination of active or inert status is located in 40 CFR 153.125 and PR Notice
(Reference: PR-81-04). Aningredient wUlbeconsideredanactiveingredientif, by itself,
it has the capacity to function as a pesticide or has the ability to elicit or enhance the
pesticidal effect  in another compound (i.e., the 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 are not generally considered to be active ingredients.

Note:  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.

RELATED COMPOUNDS (ACTIVE): If one or more related compounds is pesticidal
to the target pest, itmust be included under the ACTIVE INGREDIENTheading. For
example:
          ACTIVE INGREDIENTS:
 Ingredient Statement
                                                                Page 6-4

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 Label Review Manual
                                                 Current as of December 27,1996
3.
          • 2-Carbomethoxy-l-methylvinyl dimethyl phosphate, a isomer ........... 20.0%
         .  2-Carbomethoxy-l -methyl vinyl dimethyl phosphate, P isomer ......... . . 3.0%
           INERT INGREDIENTS: . . ........ .......... . . . ...... . . . . ....... 77.0%
           Total ............. ...... . ............ .......................... 100.0%

       RELATED COMPOUNDS (INERT)  Related compounds with  no determined
       active/inert status must  be included  under  the total  percentage of the INERT
       INGREDIENT heading without designation as related compounds or by name (PR-81-

                 '''            '  '                                          '
 4.     EQUIVALENTS: Unless declared asanactiveingredient,relatedcompoundsmustnot
       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-8 1-4).

 Statement of Percentages                                         ,

       Every label reviewer should be aware that the Office of Pesticide Programs (OPP) is in
 the process of converting all labels over to the following policy: the amount (percent by weight)
 of ingredient(s) 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 GFR 158.153(i).
 Accordingly, the Agency has established the nominal concentration as the only acceptable label
 da-im for the amount of active ingredient in the product. After July 1, 1997, all pesticide
 ingredient statements must be expressed as nominal concentration.

       Reviewers of proposed labels for products subject to deterioration, such as sodium
 hypochlorite, should note the section later in this chapter on Deterioration.

 w     As stated above, the percent by weight of the ingredients must be stated as the nominal
       concentration. The upper and lower certified limits on the Confidential Statement of
       Formula (CSF) are to be in accordance with 40 CFR 158.175. (Reference; PR-91-02)
Ingredient Statement
                                                                       Page 6-5

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Label Review Manual
                                      Current as of December 27,1996
      The definition of Nominal Concentration is: Tne amount of an ingredient which is
      expected to be present, expressed as percentage by weight in a typical sample of a
      pesticide product at the time the product is produced. The nominal concentration of
      the active ingredient in the product will be based on the nominal concentration in the
      sourceproduct. [Example: If thenominal concentration of the active ingredient source
      is 80% (as declared on the CSF, column 10) and percent by weight of the formulated
      product is 20% (CSF, column 13b), the nominal concentration based on the pure form
      of active ingredient is 16% (i.e., 20% x 0.80)]

      Products are to convert to nominal concentration under the schedule below:

      A.    Beginning July. 1,1991, all new product registrations submitted to the Agency
            were to comply with the requirements of PR Notice 91-2 (Reference: PR-91-2).

      B.    Registrants having products subject to reregistration under FIFRA Section 4(a)
            were to comply with the requirements of PR Notice 91-2 when specific products
            are called in by the Agency under Phase V of the Reregistration Program.

      C.    All other products that are not subject to (A.) or (B.) above will have until July
            1,1997, to comply with PR Notice 91-2. Applications should note "Conversion
            to Nominal Concentration" on the application form.

      The percentages of each active ingredient must be expressed in terms of weight-to-
      weight (i.e., weight of active ingredient present in the total weight of the product).

      The percentage for inert ingredients is 100% minus the total percentages) of the active
      ingredients.

      The sum of percentages of the active and the inert ingredients must be 100%. The term
      "100%" need not be expressed as part of the ingredient statement.

      For ingredient statements which reflect the fact that the active ingredients is the only
      component of the product, the inert ingredients header is not necessary. For example:
ACTIVE INGREDIENTS:
Chlorine ............ .
                                                            100.0%
       If the proposed label is for a liquid formulation, check the Directions For Use section:
       if any of the use directions of the pesticide product are expressed as a certain weight of
 Ingredient Statement
                                                              Page 6-6

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 Label Review Manual
Current as of December 27, 1996
       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. 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 directions for use are expressed as weight of
       product/unit area, the weight of the product/gallon must be stated."

 Deterioration

       Pesticides which change in chemical composition significantly over time must meet the
 following labeling requirements:

 1.      EXPIRATION DATE: In cases where it is determined that a pesticide formulation
       changes chemical composition significantly over time,  the product must bear the
       following statement in a prominent position on the label: "Not for sale or use after
       [date]." (40CFR 156.10(g)(6)(i))

 2.     EXPIRATION DATE FOR SODIUM HYPOCHLORITE: The product must meet
       all label claims up to the expiration time indicated on the label. To insure effectiveness,
       the following labeling statement is required for sodium hypochlorite (because of its
       rapid degradation). This requirement is for sodium hypochlorite products with a label
       claim of 5.25 -12.5% active ingredient.

          "Degrades with age.  Use a test kit and increase dosage as necessary to
          obtain the required level of available chlorine."

 Specific Designations for Some Ingredient Statements

       Some pesticide ingredients require specific designations on the ingredient statements for
 proper clarification and  identification.  For  instance, some bromated or chlorinated
 compounds may require a reference in the ingredient  statement to the available chlorine or
 bromine (see #7 below). Examples; of some of these specific designations are shown below:
Ingredient Statement
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Label Review Manual
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1.     MICROBIAL PESTICIDES: Microbial and Biochemical  pesticides 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, exceptfor
      differences with the ingredient statement.

      Products containing livemicroorganismsmust indicate the equivalent number of viable
      units (spores, cells, colony forming units, etc.) per unit weight of product.

      ForBacillus thuringiensis fflfl products, 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.superseded PR Notice 71-6).  The use of potency units expressed in
      terms of International Units (IU) permilligram 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 fhuringiensis subspecies knrstaki
          Lepidopteran active toxin	...		•	3.0%
          Dipteran active toxin(s)	.-	2.0%
          INERT INGREDIENTS:	21flS&
          Total	r...	..;!...........;....':. 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.

      Since the reregistration 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. Forpotency based ingredient statements for lepidopteran active Bt products,
      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  lU/mg.   Thus,  a  16,000  KJ/mg  product  would  be
      (16,000/mg) x (100%/500,000 lU/mg) = 3.2.%
Ingredient Statement
                        Page 6-8

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 Label  Review Manual
Current as of December 27, 1996
           Subdivision M (Pesticide Testing Guidelines) Microbial and Biochemical Pest
           Control Agents (July 1989) addresses this topic.

                         Certified Limits Can Be Expressed As:

       (i)  Microbial Pest Control Agents (MPCA) units/unit weight or volume
       (ii). International Units of Potency per unit weight
       (iii) Weight percent of product

       Items (i) and (ii) may be determined using biological, genetic, biochemical, serological
       or other appropriate data. For example:
       A.
           ACTIVE INGREDIENT:
           Pseudomonas cepada type Wisconsin			3.8% (by wt.)
           INERT INGREDIENTS: ...	 96.3% (by wt.)
           Total.		 100.0% (by wt.)

           Contains at least 50 million, viable cellsflb (10s ceils/gram).
       B.
           ACTIVE INGREDIENTS:                                  .
           Tncbodexmaharzianwn(A'TCC 20476)	16.6% WAV
           Tiichodenna pofysporum (ATCC 20475)		,	16.6% WAV
           INERT INGREDIENTS:  .......			.............. 66.8.% W/W
           Total	,		 100.0% WAV
           Minimum 4.5 million colony forming units (CPU) per pound (454 grams)

2.     BIOCHEMICAL PESTICIDES: The ingredients statement for a product whose active
       ingredient is a naturally occurring plant regulator, (such as cytokinin, auxin, or
       gibberellin) 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%
           INERT 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. .             .    •          .        -\      ..  •  '       "     • :   •
Ingredient Statement
                       Page 6-9

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Label Review Manual
                                         Current as of December 27,1996
ACITVE INGREDIENT:
Pheromone* .......... :
INERT INGREDIENTS:
Total
*x mg per dispenser
                                                              1-ฐฐ/0
                                                            100.0%
4.    INSECT VIRUS-BASED INSECTICIDES: Pesticidal products containing an insect
      virus as the active pesticidal 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:

                                   BICX:ONTROLrl
                 BiolopcallnsectiddefortheControlofDouglasFirTussockMoth

          ACTTVEINGREDIENT*:
          PolyhedrallndusionBodiesofDouglasFir
          TussodcMothNudearPolyhedrosisVirus . . . . '.. ........ .... .......... •
          INERTINGREDffiNTS: ......................................... •
                                                                         mm
          •Contains at least 70 million activity units per gram.
           Often the active ingredients statement will include "... and insect body parts..."
           whether the baculovirus is propagated in vivo or in vitro. For example:

                                    SPECIFIC-T-1

           ACITVEINGREDIENT:
           GranulosisVlrasofCydkPomonelk(CoddlingMoth)
           (atleast5xl08GIBS/ml) ................... ....... .......... 0.005%
           INERTINGREDIENTS:         .
           Insectparts/water^nerbolids ....... :•. . ---- . ........... .• .....  99.98%
           Aureomycin(5.5%) ...... ........ ...;..,....... ....... ...... 0.015%
           Total. ............ ......... ....... ...... ... ............  100.0%
Ingredient Statement
                                                                Page 6-10

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Label Review Manual
Current as of December 27,1996
      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%
          Isocctyl ester of 2-(2,4-Dichlorophenoxy) propionic acid** ...... 10.0%
          INERT INGREDIENTS: ..	 78.0%
          Total...	100.0%
          *2,44Mchlorophenoxyacetic add equivalent, 9.5%             ,
          **2-(2,4-DicUorophenoxy)propionic add equivalent, 9%

      COPPER SALTS OR COMPLEXES: Pesticide products whose 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. The
      analytic method needs to be in the CSF. For example:

          ACTIVE INGREDIENT:
          Copper naphthenate* .......	'..'.	 93.2%
          INERT INGREDIENTS: ...........................'...... ฃ8%.
          Total.			100.0%
          *Metallic copper equivalent, 22%                                       '

      This type ingredient statement declaration is applicable to zinc, also. For example,
      Zinc naphthenate must be expressed as percent metallic zinc equivalent.

      BROMINATED AND/OR CHLORINATED COMPOUNDS: Certain bromated or
      chlorinated compounds may require a reference in the ingredient statement to the
      available chlorine or bromine.  Forexample:

          ACTIVE INGREDIENT:
          l-Bromo-3-chloro-5, S-dimethy]hydantbin	86.4%
          l-3dibromo-5, 5-dimethylhydantoin	—	8.6%
          INERT INGREDIENTS: :	:.:.........	 LSE&
          Total		'.... 100.0%
          Provides:     66.8% Available Bromine
                      25.4% Available Chlorine
Ingredient Statement
                      Page 6-11

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Label Review Manual
                                           Current as of December 27,1996
8.
9.
10.
11.
12.
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.

SODIUM CHLORATE PRODUCTS: Because sodium chlorate is very 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 does indeed
contain a fire retardant (column 15, Purpose in Formulation).
ADDITIONAL STATEMENTS: Pesticide products which contain arsenic in any form,
must include a substatement of the percentages of total arsenic and water-soluble
arsenic calculated as elemental arsenic. For example:
     'Total arsenic, all in water soluble form, expressed as elemental = xx%"
                    .',','•   •''"'•'.••:, .  ' ]  '':: ., ;.;•" ;•• •  ..,':''.,:' .^ ,:-"X'',„", " ;- ,,  '; ',
     Formulations containing greater than 10% petroleum distillates, xyleneorxylene
     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.
FERTILIZER-PESTICIDE COMBINATIONS: Pesticides that are formulated in
combination with fertilizers must be declared in the label ingredient statement the same
way as the 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. Various fertilizer combinations may be registered under
the same registration number provided that the percentage of active ingredient remains
the same.

COMPLEXING AGENTS: In the case of complexing agents containing iodine, for
example, the active ingredient  which is titratable iodine, must be declared in the
ingredient statement with a footnote immediately below the active ingredient statement
listing the complex formed (Reference: LP95-03). For example:
           ACTIVE INGREDIENT:
           Iodine*   '	
           INERT INGREDIENTS:	
           Total	
           *from name of complexing agent
                                                          .  15.0%
                                                          .  85.0%
                                                           100.0%
Ingredient Statement
                                                                  Page 6-12

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 Label Review Manual
Current as of December 27,1996
 Inert Ingredients
 1.     SPECIAL LABELING REQUIREMENTS for Inerts of Toxicological Concern (List
       1): According  to PR Notice 87-6 (Reference:  PR-87-06), issued May 12, 1987,
       registrants of products containing one or more inert ingredients on List 1 (inert
       ingredients of lexicological concern) were required to amend their label to include the
       statement: "This product contains the toxic inert ingredient (name of inert)." This
       statement was to be placed in close proximity to the ingredient statement in a type size
       comparable to other front panel text. The Release for Shipment date was October,20,
       1988. Most registrants substituted a List 3 or 4 inert for an inert on List 1. In general,
       after the PR Notice was issued EPA did not register any new products containing a List
       1 inert.  PR Notice 90-1 (Reference: PR-90-01), 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. The PR Notice 90-1 contains all the
       lists of inert ingredients for your reference. (Refer to chapter 8 also)            \ ,

           The List 1  inert ingredients are as follows:

               LIST  1. - INERTS OF TOXICOLOGICAL CONCERN
••>
,-, CAS1M0, ">
62-53-3
1332-21-4
1332-21-9
7440-43-9
56-23-5
67-66-3
106-46-7
103-23-2
78-87-5
117-87-8
66-12-2
123-91-1
106-89-8
110-80-5
'*' <;- " "",- ^C&eHปซ$K*B>ซ '
Aniline
1 Asbestos fiber
1,4-Benzenediol
Cadmium compounds
Carbon tetrachloride
Chloroform
p-Dichlorobenzene
DH2-ethylhexyl)adipate.
1 ,2-Dichloropropane
Di-ethylhexylphthalate
Dimethylformamide
Dioxane
Epichlorohydrin . r
2-ethoxyethanol
Ingredient Statement
                     Page 6-13

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Label Review Manual
                               Current as of December 27,1996
        CAS No.
    111-15-9
Etfaanol ethoxyacetate
    107-06-
Eihylene dichloride
    109-86-4
Ethylene glycol monomethyl ether
    140-88-5
    110-54-3
Ethyl acrylate
n-Hexane
    302-01-2
Hydrazine
    78-59-1
Isophorone
    7439-92-1
Lead compounds
     J68-64-2
Malachite green
    591-78-6
Methyl n-butyl ketone
    74-87-3
Methyl chloride
    75-09-2
    25154-52-3
Methylene chloride
Nonylphenol
     127-18-4
Perchloroethylene
     108-95-2
Phenol
    90-43-7
o-Phenylphenol
    75-56-9
Propylene oxide
     8003-34-5
Pyrethrins
     81-88-9
RhodamineB
     10588-01-9
 Sodium dichromate
     26471-62-5
Toluene diisocyanate
     79-00-5
     56-35-9
 l.lJZ-Trichloroethane
 Tributyl tin oxide
     79-01-6
 Trichloroethylene
     1330-78-5
 Tri-orthocresvlphosphatc (TOCP)
     78-30-8
 Ingredient Statement
                                                         Page 6-14

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 Label Review Manual
Current as of December 27,1996
 2.     IDENTIFICATION OF INERT INGREDIENTS: Inert ingredients are not required
       to be identified individually in the ingredient statement label except when determined
       that such inert ingredient may pose a hazard to man or the environment.  In such a
       situation, it may be required 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 statementheorshemustlistallinertingredientsdirectlybelowtheingredient
       statement. Registrants have the option of including descriptive terms (e.g., cleaning
       agent, perfume) in parentheses after each inert listed. For example, "inert (perfume)."

 Alternate Formulations

       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)(l)
 through (4). The Agency may require the submission of data to determine whether the criteria
 have been met.

       ซ•   The alternate formulation must have the same certified limits for each active
            ingredient as the basic formulation.

       •*•   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.

       ซ•   The label text of the alternate formulation product must be identical to that of the
            basic formulation. 40  CFR 152.43 prohibits alternate formulations if the
            alternate formulation requires a change in the label text.

       •*•   The analytical method required under 40 CFR 158.180 must be suitable for use
            on both the basic formulation and the alternate formulation.

       ซ*•   Usually the alternate formulas are named "Alternate Formula A," "B," etc. if
            there are more than one alternate formula.
Ingredient Statement
                     Page 6-15

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Label Review Manual
                      Current as of December 27,1996
Chapter?
USE CLASSIFICATION
Introduction

      Pesticide products may be classified as restricted use pesticides (RUP), general use, or
unclassified. A product may be classified as a restricted use pesticide when the product meets
certain criteria indicating that  it poses a threat to man, non-target organisms or  the
environment and labeling cannot sufficiently mitigate the hazard (40 CFR 152.170); and special
training in handling and applying the pesticide product is necessary to ensure the safe use of
the product.  According to the regulations, the sale of restricted use pesticides is limited to
certified applicators foruseby those applicators or persons under their direct supervision. The
use of unclassified products are not limited in any manner, except in cases where a product
bears labeling limiting the use to a specific group such as veterinarians, etc.-

Unclassified Products     •       .  •
           ''           "         , -             "               .',.'•-  \
   To determine if a product is unclassified, review the criteria below:

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 are
      submitted and none Of the following data reviews indicate that the product should be
      considered for restricted use classification.

          ป  Ecological Effects and  Environmental Fate and Groundwater Division:
              Assesses the toxicity to fish, wildlife, and endangered speciesand assesses the
              possibility of groundwater contamination  and persistence in soil.

          ' ซ*•  Chemistry and Exposure Branches (CB-I or n):  Assesses the hazard of
              handler exposure.

          •sr  Technical Review  Secction (RD/TRS): Assesses the acute toxicity of  the
              product.

3.     MUP's:  The product under review is a manufacturing use product (MP).  MP'smust
      bear labeling indicating that the product is used solely for formulating end-use products.
      The label for an MP should list the use-sites claimed on pesticide products formulated
Use Classification
                                             Page 7-1

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Label Review Manual
Current as of December 27,1996
      with it as the active ingredient. Do not confuse this list of uses with end-use directions.
      A separate registration is required for end-use products.

4.    The product under review does not contain active ingredient(s) and use(s) which have
      been classified as restricted use. To check: Refer to 40 CFR152.175, or if the product
      is currently registered, the RUP classification can be checked using the Reference Files
      System (REFS) on "Page 1" of the product information.  Another reference source for
      this information is the Pesticide Information Network (PIN). This database includes
      registration numbers of Restricted Use Products and lists the reason for restricted use
      classification.  (Instructions for accessing data base are located at the end of this
      chapter).

      If the label under review meets any of the above criteria, then the product is unclassified.
      Review Item 2. below and then Skip to the next chapter.  If the label under review does
      not meet any of the above criteria, then the product may. be classified as a RUP. Go to
      the next section entitled "Products Which May Be Classified as a RUP."

General Use Pesticides                          ,

      Unclassified products with one exception do not bear the term "General Use" as
   discussed in 40 CFR 152.160. The one exception involves products containing the active
   ingredient, chlorine gas.  These products are the only products which may bear the
   classification "General Use." If the label under review involves a product containing an
   active ingredient other than chlorine gas and the label contains the pesticide  classification
   "General Use", instruct the registrant to remove the designation in accordance with Policy
   and Criteria Notice 2460.2 (Reference: P&C 2460-2).

Restricted Use Pesticides fRUF>            .
            ซ           •        .'''••;--'    1     '•           •             •  t""'
                                     '      . '    •* i"          ,    •        •   " •    , '",
1.    DETERMINATIONOF CLASSIFICATION: Review the criteria below to determine
      whether the product should be classified as a RUP.
                                                 i     •:  '.    • •    , .     '.'         ,   :
      A.  If the product under review is a me-too registration and the cited product is
          classified as a RUP, then the product label under review must bear the Restricted
          Use classification. Go to Section 2 below on "Labeling Requirements  for Restricted
          Use Pesticides."                                      '.....'

      B.  If the product under review was accompanied by data and any of the data reviews
          from Ecological Effects and Environmental Fate and Groundwater Division and
Use Classification
                       Page 7-2

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 Label Review Manual
                                           Current as of December 27,1996
3.
     Chemistry and Exposure Branches (CB-1 or II) indicate that the product should be
     classified as a RUP, then the product label under review must bear the Restricted
     Use classification. Go to Section 2 below on "Labeling Requirements for Restricted
     Use Pesticides."                                     .

 C.  If the product under review was accompanied by data and the data review from
     precautionary  reviewers indicate  that  the  product  meets the  criteria  for
     consideration as a RUP, then the label reviewer should check with the Product
     Manager/team leader to determine if the product should actually be classified as an
     RUP/ '•'-...'      :      :,        "•'.:-.-     ;         •.   .  IN

 RECORDING CLASSIFICATION DECISION: If the PM/team leader determines
 that the product should not be classified as a RUP, 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 CFR152.170(e), including thealternative labeling language required.
 The label reviewermust sign and date the memo and place it in the registration jacket.
 The label reviewer should make sure the product label under review doesnot bear any
 use classification (Refer to Section 2 above on Discontinuance of Term "General Use").
 The remainder of this chapter can be skipped as it is not relevant to the label under
 review.

 If the PM/team leader determines that the product should be classified as a RUP, go to
 the Section 3 below to determine the proper labeling requirements for Restricted Use
 Pesticides.

 PLACEMENT REQUIREMENTS FOR RUPs: Restricted use pesticides are subject to
 the labeling  requirements specified in 40  CFR  156.10(j)(2)  and PR Notice 93-1
 (Reference: PR-93-01). Check the label under review to make certain that the label
meets the RUP labeling requirements listed below:

A.  The statement "Restricted Use Pesticide" appears at the very top of label's front
   , panel, 40 CFR 156. iO(j)(2)(i).

B.  No other wording or symbols may appear above the RUP statement.

C.  RUP statement is followed by the reason for RUP classification. (See Chapter 7,
    page 4 for examples of chemical specific RUP statements and reasons for RUP
   classification).
Use Classification
                                                                 Page 7-3

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Label Review Manual
                                           Current as of December 27,1996
   4.
D.  RUPstatementshouldbeenclosedinaboxsothatitismorevisibleonlabel.(This
    is preferred).

E.  RUP statement appears with sufficient prominence in relation to other label text
    and graphics so as not to be overlooked (40 CFR 156.10(j)(2).

F.  The label must bear the phrase "Restricted Use Pesticide"  under the heading
    "Directions for Use" (40 CFR 156.10 (i)(2)(ii).

G  The phrase "Restricted Use Pesticide" meets the minimum type size requirements
  '  of the human hazard signal words.  If type size appears small, Ihe label reviewer
    should remind the registrant of the type size requirements specified in the Code ot
  '  Federal Regulations at 40 CFR 156.tO(h)(l)(iv) for the signal word.

H  The label may not bear any  type of designation indicating that certain uses are
    restricted and other uses are not restricted. A restricted use product may bear any
    or all uses.  However, if the product has uses which are not restricted and the
    registrantdeskestomarketorniakea^
    the registrant must seek a separate registration for these uses.

WORDING OF RUP STATEMENT:  The Label must bear the correct RUP
statement, 40 CFR 156.100)(2)(i)(B), or other specific statements required for certain
chemicals as listed below.

A. The general RUP statement listed at 40 CFR 156.10(j)(2)(i)(B) is 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."

 B   Some pesticides require a specific RUP Statement. Many RUP statements are
     applicable to specific products, rather than the chemical. Check the appropriate
     science review, your Product Manager or team leader, to determine if a specific
     RUP statement is required. Also, check with REFs or the  Chemical  Review
     Manager/team leader for the status of the Reregistration Eligibility Document
     (RED) for the chemical. If a RED has been issued, check the RED for any specific
     guidance for Restricted Use Pesticide classification and/or associated labeling.
     NOTE: Additional specific RUP statements will be added to the manual as they
     are identified.
 Use Classification
                                                                         Page 7-4

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Label Review Manual
Current as of December 27,1996
           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."
          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."
          Atrazine
          'ป.-'•         RESTRICTED USE PESTICIDE
                         (GROUND WATER CONCERNS)

               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.

               "This product is a restricted use herbicide due to ground water concerns.
               Users must read and follow all precautionary statements and instructions for
               use in order to minimize potential for atrazine to reach ground water."
               (Reference: LP90-01).                                    V

          Diazinon

          er   "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."

          Ethyl Parathion                               _

          ซ*•   "For retail sale  only to certified commercial aerial applicators or,persons
               under their direct supervision.  For use only by certified commercial aerial
               applicators.  Direct supervision for this product is defined as the certified
               commerdalaerialapplicatorbe^gphysicallypresentduringmixuig, loading,
               repair and cleaning of application equipment.  Certified commercial aerial
Use Classification
                      Page 7-5

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Label Review Manual
Current as of December 27,1996
               applicators must also ensure that all persons involved in these activities are
               informed of the precautionary statements."
          Fortresse
               "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."
          Guthionฎ
               "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."
          Hydrogen Phosphide
                                            '    '*''-..,        •      •     .''','
          ur   "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
           t  Research Products Company product manual which contains complete
               instructions for the safe use of this pesticide."

          Creosote

          or   "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."

          Oxamyl                                          '

          ซ*•   "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."
Use Classification
                       Page 7-6

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 Label Review Manual
                                        Current as of December 27,1996
           Methomyl

           ซy    "Due to Mgh acute toxicity to humans.  For retail sale to and use only by
                Certified Applicator or persons under their direct supervision, and only for
                those uses covered by the Certified Applicator's certification.   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."

           Sodium Cyanide

           ซ•    Note-some of the statements in the RUP boxes on most or all Sodium
                Cyanide M-44 Capsule labels were being ; revised (Fall 1996).

           Sodium Fluoroacetate (when used on sheep or goats to kill depredating coyotes)

           ซ*•       "Collars shall be sold or transferred only by registrants or their agents and
                   only to certified Livestock Protection Collar applicators. Collars may be
                   used only by specifically certified Livestock Protection Collar applicators
                   or by persons under their direct supervision."

           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."
          Aldicarb (Temikฎ brand)

          ป   "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."                       ,

          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."
Use Classification
                                                              Page 7-7

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Label Review Manual
Current as of December 27,1996
                             Accessing the PIN

  ThePestitidelnfornmtionNetwork^
historic pesticide information. The system is operational 24 hours a day, and is all menu
driven easy to use and can be accessed by anyone with a computer through the LAN (modem
pool) The phone number for accessing the PIN is 703-305-5919. Once into the PIN, simply
follow the instructions in the menu driven system. Various reports can be down loaded from
theRestricted Use Products file. Call Leslie Davies-Hilliard for user support at 703-305-7499.
 Use Classification
                                                                      Page 7-8

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 Label Review Manual
                          Current as of December 27,1996
 Chapter 8
PRECAUTIONARY LABELING
 Introduction

       Precautionary labeling provides the pesticide user with information regarding the
 potentialtoxicity,irritationandsensitizationhazardassociatedwiththeuseofapesticide. The
 precautionary labeling also identifies the precautions necessary to avoidexposure, any personal
 protective equipment (PPE) which should be used when handling a pesticide and first aid in
 case of accidental exposure.

       This chapter is organized into the following five major parts:

             Background Information
             Detennination of Products Subject to the Worker Protection Standard
             Precautionary Labeling
             First Aid (Statements of Practical Treatment)
             Optional Labeling and Deviations

 Background Information

 1,     ACUTE TOXICITY DATA:  The precautionary labeling which includes the signal
       word, personal protective equipment and first aid statements is normally determined by
       six acute toxicity studies and product composition.  The acute oral, acute dermal and
       acute inhalation studies measure the lethality of a product via the designated route of
       exposure. The primary eye irritation and primary skin irritation studies measure the
       severity of irritation or corrosivity caused by a product. The dermal sensitization study
       determines whether a product is capable of causing an allergic reaction.  With  the
       exception of the dermal sensitization study each acute toxicity study is assigned a
       toxicity category (See Table 1 below).
                            Table 1 - Toxicity Categories
Study
Acute Oral
Acute
Dermal
Acute
Inhalation1
Category I
Up to and including SO mg/kg
Up to and including 200 mg/kg
Up to 'and including 0.05
mg/liter
Category H
> SO thru 500 mg/kg
> 200 thru 2000
mg/kg
> 0.05 thru 0.5
mg/liter
Category in
> 500 thru 5000 mg/kg
> 2000 thru 5000
mg/kg
> 0.5 thru 2 mg/liter
Category IV
> 5000 mg/kg
> 5000 mg/kg
> 2 ing/liter
Precautionary Labeling
                                                Page 8-1

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Label Review Manual
                                     Current as of December 27,1996
   Bye
   Irritation
   Skin
   Irritation
Corrosive (irreversible
destruction of ocular tissue) or
corncal involvement or -
irritation persisting for more
than 21 days
Corrosive (tissue destruction
into the dermis and/or scarring)
Cornea! involvement
or irritation clearing
in 8-21 days
Severe irritation at 72
hours (severe
erythema or edema)
Cornea! involvement
or irritation clearing in
7 days or less
Moderate irritation at
72 hours (moderate
erythema)
Minimal
effects
clearing in less
than 24 hours
Mild or slight
irritation (no
irritation or ,
                                                                          erythema)
 4hrexposure        '                       •-'.'..               .

2.     GUIDANCE DOCUMENTS USED TO DETERMINE LABELING: The Code of
       Federal Regulations specifies both acute toxicity categories (40 CFR 156.10(h)(l)(i))
       and precautionary labeling statements associated with each toxicity category (40 CFR
       156J(Kh)(2)).Theseacutetoxidtycategoriesandprecautionarylabelhigstatementsare
       not currently being used by the Agency as they are less detailed and provide less
       protection for pesticide users than other guidance.  The 40 CFR 156.10(h)(2)(i) states
       that precautionary labeling statements listed therein can be modified or expanded to
       reflect specific hazards.  The precautionary labeling provided in the Federal Register
       notice issued on9/26/84entitiedProposedRuleonLabeling Requirements (Volume49,
       Number 188) is being used because it is more detailed and provides better protection.
       The acute toxicity categories listed in the proposed rule are also being used with one
       exception. The acute inhalation toxicity categories 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. The Worker Protection Standard
       issued in 1992 is the major guidance document for labeling of agricultural products.
       That document is also being used to determine type of respiratory protective equipment
       for products which are not subject to the WPS.

 Termination of Products Subject to the Worker Protection Standard fWPS)

       Review this section to determine whether the label under review involves a product
 which is subject to the WPS.  WPS does not apply to manufacturing use products, or to
 unregistered pesticides used under an experimental use permit issued under the Federal
 Insecticide, Fungicide and Rodenticide Act (FIFRA) section 5 or under an exemption issued
 under FIFRA section 18.  This determination is  important when reviewing the following
 Precautionary Labeling
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  Label Review Manual
Current as of December 27,1996
  sections of this manual because the personal protective equipment for WPS products is more
  specific and there are some additional labeling requirements.

        ซ?    Does the product bear directions for use involving the production of an
  agricultural plant on a farm, forest, nursery, or greenhouse or does the product bear labeling
  which could reasonably permit such a use?

              ป     NO:  The product is not subject to the WPS. Go to the next
              section on Precautionary Labeling.

              ซ•     YES: Does the product meet any of the exceptions listed below?

  EXCEPTIONS: Does the product bear directions solely for any of the following msas?

 • *  •   For mosquito abatement, Mediterranean fruit fly eradication, or^similar wide-area
       public pest control programs sponsored by governmental entities.
  *     On livestock or other animals, or in or about 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."

  +     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.

. *     For control of vertebrate pests.

 *    ,As attractants or repellents in traps.     A

• >     For research uses of unregistered pesticides.

       ซ•     NO:   the product IS subject to the WPS.

       ซ•    YES:  The product is NOT subject to the WPS.

 Please Remember:
Precautionary Labeling
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Label Review Manual
                                    Current as of December 27,1996
      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
adding one of the following exclusionary statements.  For example:

             "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."

       For further details, see PR Notice 93-11, Supplement F.
 Precautionary I
       If toxicity categories are known:   Use the toxicity  categories to determine the
 appropriate labeling identified in the following sections of this chapter.

       If toxicity categories are not known, as in the case of many me-tbo submissions, the
 label review will essentially involve a comparison of the draft label against the cited label.
 Cited labels often contain errors themselves. To ensure that these errors are not passed
 on to the Me-too label, review the following sections of this chapter to verify that the
 draft and cited labels are correct.

 1.     SIGNAL WORD:  Review the following to determine the correct signal word and its
       location:   .                              .
       A.
Correct Signal Word: The signal word is determined by the most severe toxicity
category assigned to the five acute toxicity studies or by the presence of special
inerts ( methanol in concentrations of 4% or more). Refer to the acute toxicity
data review to determine the most severe toxicity category.  Also check the
 Precautionary Labeling
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             confidential statement of formula to determine if methanol is present. If acute
             toxicity categories are not known, the signal word on the label under review
             must be identical to the signal word on the cited product. Signal words are as
             follows:

             Toxicity Category I - DANGER
             Toxicity Category H - WARNING
             Toxicity Categories III & IV - CAUTION

       B.    Required Location: The signal word may only appear in three places on the
             label. It must appear on the front panel of the label immediately below the child
             hazard warning statement, in the precautionary labeling section immediately
             below the subheading "Hazards to" Humans and Domestic Animals" and in the
             WPS posting statement if one is on the label.

       C.    Other Requirements: Make sure that the label text does not contain the terms
           ,  "caution," "warning" or "danger" except as the signal word for that label. (e.g.,
             "CAUTION: Washhandsbeforeeating, or smoking" on a "WARNING" label).
             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. Make sure that the signal word does not appear on the same line with the
             child hazard warning and that the signal word runs parallel with other label text.
             It is preferred that the signal word appears in all capital letters.

       D.    WPS Products: Products subject to the WPS which 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 the 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 which  must  appear on
             toxicity category I and II WPS products is as follows:

                  "Si listed no entiende la etiqueta, busque a alguien para que
                  se la exptique a listed en detaUe. (If jrou do not understand
                  the label, find someone to explain it to you in detail.)"

2.    POISON - SKULL & CROSSBONES DETERMINATION:  The word "POISON"
      and the skull and crossbones symbol are required whenever a product is classified as
Precautionary Labeling
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Label Review Manual
Current as of December 27,1996
      toxicity category I due to the results of either the acute oral, acute dermal, or acute
      inhalation toxicity studies (40 CFR 156.10(h)(l)(i)) or if the inert ( Methanol 4% or
      more) are present in the product [1984 proposed labeling rule, Part 156.50].

      A.    Required Location: The word "Poison" and the skull and crossbones symbol
             must appear in immediate proximity to the signal word which must  be
             "DANGER."                           -

      B.    Display  Requirements:  "Poison"  must appear in red on  a contrasting
             background.  If the proposed label does not indicate these display requirements,
             include this requirement in your response to the registrant.

         Table 2 - Acute Toxicity Category Determination For Sample Products
Type of Study
Acute Oral
Acute Dermal
Acute Inhalatioa
Primary Eye
Primary Skin
Special Inert
CORRECT
SIGNAL WORD
Product A
m
IV
m
m
rv
No
CAUTION
Products
IV
. m
rv ,
n
rv
No
WARNING
Product C
I
m
m
i
n
No
DANGER*
Product D
m
rv
m
I
IV
No
DANGER
Product B
n
n
n
n
n
, Yes
DANGER*
   "Product C and Product E must also bear additional labeling (Skull & Crossbones symbol mdow 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 must bear the
   additional labeling because it contains a special inert ( Methanol) which is described above in the first paragraph.

3.     CHILD HAZARD WARNING STATEMENT: The phrase "Keep Out Of Reach Of
       Children" is required on almost all product labels. The child hazard warning statement
       may be completely omitted for manufacturing use products.  A modified child hazard
       warning statement may be used for products where child contact is  expected.   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" (1984
       proposed labeling rule, 156.46).
Precautionary Labeling
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 Label Review Manual
                                            Current as of December 27,1996
 4.
 A. Required Location: The child hazard warning statement must appear on the front
    panel (40 CFR 156.10(h)(l)(ii)).

 B. Other Requirements: It is also preferred that the child hazard warning appears on
    a separate line above the signal word. The CFR does not include this specific
    requirement. However, it is included in the 1984 proposed labeling rule. When the
    signal word and child hazard warning appear on the same line, a pesticide user may
    assume that the signal word is intended more so 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, instruct the registrant to revise the label.  Also
    make sure that the child hazard warning statement runs parallel with other label
   /text.       -.'••:- •/,."'•'•'.      -•'   '.'"' ',-      '  .   -   '•'    •     .'".  "  .

    Make sure that the "Precautionary Statements" and the "Directions for Use" dojiot
    contain any statements which imply that the product may be used by children. For
    example, draftlabels of products intended to repel insects may contain instructions
    such as "Do not allow use by small children without close adult supervision." Such
    labeling is unacceptable as it implies that a child can apply the product as long as an
    adult watches. Such a statement conflicts with the child hazard warning statement.
    Pesticide products should not be applied by children because they may be incapable
    of reading and correctly-following the directions for use.

PRECAUTIONARY STATEMENTS: Precautionary statements are required for each
acute toxicity study classified as toxicity category I, II, or m and for products found to
be dermal sensitizers.

A.   Required Header: The precautionary statements must appear under the heading
      "Precautionary  Statements"  and the  appropriate subheading  "Hazard-to
   :   Humans and Domestic Animals." The phrase "... and Domestic Animals" may
      be left off if it is inappropriate or list separately from Hazard to Humans. The
      signal word must appear after the subheading.

B.    Required Location:  The precautionary statement section may appear on any
      panel.  Please note that the precautionary statements must not be included
      within the "Directions For Use" section.; With the exception of PPE for early
      reentry, all PPE must be located in the precautionary labeling section.
Precautionary Labeling
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Label Review Manual
                                          Current as of December 27,1996
C
D
                             K The precautionary statements should be organized so that
            the most severe routes of exposure as demonstrated by the toxicity category
            classification are listed first.

            Fumigants:  Refer to PR Notice 84-5 (Reference: PR-84-05) and Registration
            •Standards   and/or  Reregistration  Eligibility  Documents  (REDs)  for
            precautionary statements.

            Determining Statements  For All Other Products:   Select precautionary
            statements fromthe tables below based on the toxicity category assigned to each
            study. In cases where the toxicity categories are not known, the precautionary
            labeling for at least one route of exposure must be consistent with the signal
            word Sentences from the various tables may be combined to form a concise
            paragraph containing the precautionary labeling statements.  Repetitious
            sentences should be omitted.

            (1) Products Not In Scope of WPS: Use the precautionary statements and [PPE
            contained in this section, Tables 3 through 8 and then go to the section entitled
            TOfct Aid ^statements of Practical treatment).

             (2) Products In Scope ofWPS: Use the precautionary statements hi this section,
            Tables 3 through 8. Disregard the PPE contained in the Tables 3 through 8.
             Refer to Sections 5 through 8 to  determine the PPE for WPS products.
 Precautionary Labeling,
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Label Review Manual
Current as of December 27,1996
                         Table 3 - Acute Oral Toxicity Study*
Toddf?
Category
I
n
m
IV
, •> *•
X i ,, ** ""^
/ gjgaal Wosii-
DANGER
Skull & Crossbones
required
WARNING
CAUTION
CAUTION
f f fff f f ' v. % •. *
f ff f f
ffewซitkajaiy Sfeteinwste nwl Jtocjaal ffcolsctlW Bg^pflwW*^ ,
Fatal if swallowed. Wash thoroughly with soap and water after
handling and before eating, drinking, or using tobacco.
May be fatal if swallowed. Wash thoroughly with soap and water
after handling and before eating, drinking or using tobacco.
Harmful if swallowed. Wash thoroughly with soap and water
after handling.
No statements are required. However, if the registrant chooses to
use category HI labeling that is acceptable.
       'Products Containing 4% or more of Methanol: Add the following to the precautionary statements:
       "Methanol may cause blindness."                                        -

                        Table 4 - Acute Dermal Toxicity Study
, *sปปcfejf,
vi&tfegaty -
I
n
m
IV
-. ' "-.,$ f
' 	 %nafซrjปd - ,
" DANGER
Skull & Crossbones required
WARNING
CAUTION
CAUTION
•> f ' ' ff f f fff* f"'f f
,,,.. Kซcautionm^SlatmBBatssurfiteacmBlfeeซcซivK^^^
Fatal if absorbed through skin. Do not get in eyes, on skin, or on clothing.
Wear protective clothing and gloyes (specify protective clothing and type of
gloves). Wash thoroughly with soap and water after handling and before
eating, drinking, or using tobacco. Remove contaminated clothing and wash
• before reuse. • ~ - * -
May be fatal if absorbed through skin. Do not get in eyes, on skin, or on
clothing. Wear protective clothing and gloves (specify protective clothing
and type of gloves). Wash thoroughly with soap and water after handling
and before eating, drinking or using tobacco. Remove contaminated
clothing and wash clothing before reuse. "
Harmful if absorbed through skin. Avoid contact with skin, eyes or
clothing. Wash thoroughly with soap and water after handling.
No statements are required. However, if the registrant chooses to use
category HI labeling that is acceptable. , •
Precautionary Labeling
                       Page 8-9

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Label  Review Manual
Current as of December 27,1996
                         Table 5 - Acute Inhalation Toxicity Study
Toxfcky
Category
I
n
m
IV
. ' ' ".-/'"' '*,,
$KBฃW&ฃ * s -x *
DANGER
Skull & Crossboncs required
WARNING
CAUTION
CAUTION
,\ I j^ttfcs^ltet*^^ ""
Fatal if inhaled. Do not breathe (dust, vapor, or spray mist).* [Identify
specific respiratory protective device approved by the Mine Safety and
Health Administration and the National Institute for Occupational Safety
and Health.]** Remove contaminated clothing and wash clothing before
reuse.
May be fatal if inhaled. Do not breathe (dust, vapor or spray mist).* Wear a
mask or pesticide respirator jointly approved by the Mine Safety and Health
Administration and the National Institute for Occupational Safety and
Health. Remove contaminated clothing and wash clothing before reuse.
Harmful if inhaled. Avoid breathing (dust, vapor or spray mist).' Remove
contaminated clothing and wash clothing before reuse.
No statements are required. However, if the registrant chooses to use
category in labeling that is acceptable. -
       * Choose the word which appropriately describes the product during use.
       ** Refer to Section to determine the specific respiratory protective device, this section can be used for both WPS
       and Non-WPS products.            '                       .                             . ,

                           Table 6 - Primary Eye Irritation Study
ToxW^
Cutofocy
I
n
m
IV
* ' ฐ •••
SigiปIWซซt J
DANGER
WARNING
CAUTION
CAUTION
^' Att ^;!V^^t^^S
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 Label Review Manual
Current as of December 27,1996
                             Table 7 - Primary Skin Irritation Study
Tofcicity
" tJategtfcy
I
n
m
IV
SigoalWarti
DANGER
WARNING
CAUTION
CAUTION
% > % ' •"••
{%eom^twBxyi^ซmKiflUaM!PtosoB^ftmtei^e^ซiiptmt^ '
Corrosive. Causes skin burns. Do not get in eyes or on clothing. Wear protective clothing
and gloves (specify protective clothing and type of gloves)*. Wash thoroughly with soap and
water after handling. Remove contaminated clothing and wash clothing before reuse.
Causes skin irritation. Do not get on skin or on clothing. Wash thoroughly with soap and
water after handling. Remove contaminated do thing and wash clothing before reuse.
Avoid contact with skin or clothing. Wash thoroughly with soap and water after handling. '
No statements are required. However, if the registrant chooses to use category HI labeling
that is acceptable, „ •
       *Thc need for rubber (homeowner products) or chemical resistant gloves must be determined on an individual basis.
       Some products cause blistering if confined under clothing.

                          Table8-DermalSensitization Study
X-. •, *• fvw J &f f
Product is a sensitizer or is
positive for sensitization.
Product is not a sensitive or is
negative for sensitization.
i ;rf T^vrfejSaW*-^-- :-,;%^
Prolonged or frequently repeated skin contact may cause allergic reactions in
some individuals.
No labeling is required for this hazard. ' . .
5.     WPS  PERSONAL  PROTECTIVE  EQUIPMENT (PPE) REQUIREMENTS:
       Personal protective equipment is required for both pesticide handlers as well as workers
       who reenter treated areas prior to the expiration of the restricted entry interval (REI).

       A.    Determining Toxicity Categories for Each Route of Exposure:  If all acute
             toxicity categories are known, skip to Section B. If any acute toxicity categories
             are unknown, review this section to determine the preferred order for selecting
             alternate data to establish a toxicity category for the missing data:

             (1)    If available, use the toxicity categories assigned to the acute dermal
                    toxicity, acute inhalation toxicity, primary eye irritation, and primary
                    skin irritation data on the end-use product.

             (2)    If either the acute dermal toxicity or acute inhalation toxicity data are
                    missing, use the toxicity category assigned to the acute oral toxicity data.
Precautionary Labeling
                       Page 8-11

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Label Review Manual
Current as of December 27,1996
             (3)    If the acute oral, acute dermal and acute inhalation toxicity data are
                   missing, use the product signal word to determine the equivalent toxicity
                   category.
                                                 1: '     " • ,  ' "    • ' '"• , "' •   ',''',     ',,",, ''X'i'i',1,1,
      B.     WPS Products: Use the toxicity categories to determine from Table 9 whether
             the label under review contains the appropriate PPE.
                       ,'  .    .'    :'  '" . .;    ;';',, ••''"'.'  ' -^'x' :'    ;  , :"; '" '.:•''"'•' ;'' i  , .:'''';'';#
             Statements for Contaminated Personal Protective Equipment

             Use the following statement if the signal word is "Danger" or "Warning" and 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):

                   "Discardclothmgandotherabsortentmaterialsthathavebeendrenched
                   or heavily contaminated with this product's concentrate. Do not reuse
             •'  "• them." • '   '     ••••••     "   .  •_•- ••	,.   	•••' • •  •	••?•"•
Table 9 - Personal Protective Equipment for WPS Products
Route of
Exposure
Dermal
Toxkity
or Skin
Irritation
Potential1

.

Inhalation
Toxicity
Eye
Irritation
Potential
j; ;;'T*f^%<^^V%^ ,> *"\~: ;
IV (CAUTION)
Long-sleeved shirt
and long pants
Socks
Shoes
^
No minimum3

No minimum

No minimum


 'Refer to section 6 for PPE for product using Water Soluble Packaging.
 Precautionary Labeling
                        Page 8-12

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 Label Review Manual
Current as of December 27,1996
 2If dermal toxicity and skin irritation toxicity categories ate 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 C below to determine if additional
 PPE is required beyond that specified in Table 9.

 /Refer to Section 7 to determine the specific type of chemical-resistant glove.

 *Refer to Section 8 to determine the specific type of respiratory protection.

 'Although no minimum PPE is required for these toxicity categories and routes of exposure, the Agency may require PPE on
 a product-specific basis.      '                                  '              •                ,

        C.    PPE for Dermal Protection: Additional PPE is required for products which are
              classified astoxicity category I or n for acute dermal toxicity or skin irritation.
              If the label under review does not involve a category I or H classification for
              either of these studies, skip this section and go to Section 6. If the label under
              review does involve a category I or H classification for either the acute dermal
              toxicity or skin irritation, review the following table to determine the additional
              PPE which must appear on the label under review.

             Table  10 - Additional Dermal toxicity and/or Skin Irritation PPE
'Ctoadko^Rt^^
All products which arc not ready to use and do not require a
chemical resistant suit must bear the corresponding statement:
All products having applications which might involve overhead
exposure must bear the corresponding statement: •
All products involving use of equipment other than the product
container to mix, load or apply the product must tear the
corresponding statement:
;/- ""' Rc^BKCdl^B^Lซbi^f-' ^^ ^ v.
"When mixing and loading wear a chemical resistant
apron."
"For overhead exposure wear chemical-resistant
headgear."
"When cleaning equipment add a chemical-resistant
apron." , • '
6.     ENGINEERING CONTROL SYSTEMS SECTION:  If the product in the water
       soluble bag is subject to the Worker Protection Standard, then the following language
       should be placed in the engineering control section using the placement in PR Notice
       93-7.

       A.     This label language is to be used for end-use products classified as category I or
              II for either acute dermal toxicity OR skin irritation potential. (NOTE: If either
              of these data is not available, use the end-use product signal word as a surrogate.
              Signal words DANGER and WARNING indicate toxicity category I and II
              respectively.)
Precautionary Labeling
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Label Review Manual
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                   "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 maybe reduced ormodified as specified in the
                   WPS."
                                                 II   ,,.,!,„,.  ,   •      ,!•    |     • ,l, ',.JM,
                   "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
                   oflong-sleeved shirt, longpants, shoes, socks, achemical-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.     This label language is to be used for end-use products classified as category IH
             or IV for acute dermal toxicity AND skin irritation potential. (NOTE: if either
             of these data is not available, use the end-use product signal word as a surrogate.
             Signal word CAUTION indicates toxicity category  DI or IV.)

                   "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 ormodified as specified in the
                   WPS/'         ,.,  ._..'./."  _ ;..':;   ,;;.  .,;   ,;;,' v   :,__.'.  ;.:,  '[

                   "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
                   oflong-sleeved shirt, long pants, shoes, and  socks."

                   "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."
 Precautionary Labeling
                       Page 8-14

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  Labef Review Manual
                                             Current as of December 27, 1996
  7.     CHEMICAL RESISTANT GLOVE SELECTION FOR HANDLERS:  Chemical
        resistant gloves are required for all WPS products classified as toxicity category I, n,
        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 theproduct formulation.  Pleasenotethattheregistrantcanspecifyanotherchemical
        resistant glove type other than those specified below if information is available that
        indicates that another glove type provides greater protection. If the label bears another
        chemical resistant glove type and the registrant has indicated that it is more protective
        based on available information, allow that glove type to remain on the label. Ifthe label
        bears another chemical resistant glove type than those listed below and the registrant
        has not indicated that it is more protective based on available information, requestthat
        the registrant verifythat the appropriate chemical resistant glove type is on the label.
        The label must indicate the  specific type "of chemical resistant glove (such as nitrile,
        butyl, neoprene, and/or barrier laminate). See the solvent listin PR Notice 93-7, pp. 13-
        15. For those solvents not listed contact the Chemistryand Exposure Branches (CB-I
        orlT).  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 solvents other than water less than 5%, the glove statement
              shall specify "waterproof gloves."  (Reference: Supplement ffl, Main Labeling
              Guidance, Page 11, of PR Notice 93-7.

       B.     Aqueous-Based Foonulatioos applied as formulated or diluted solely with
              water for application,, the glove statement shall specify "waterproof gloves."

              Other Liquid Formulations which areformulatedordiluted 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."

             Gaseous Formulations or Formulations applied as Gases will retain any
             existing glove  statement established  before 10/20/92 including any glove
             prohibition statement. If no glove statement or glove prohibition currently exist
             on the label, then the glove statement shall be "chemical-resistant (nitrile or
             butyl) gloves."

8.     SPECIFIC RESPIRATORY PROTECTION DEVICE (RPD)  SELECTION FOR
       HANDLERS: RPD(s) are required for all products classified as toxicity/category I or
       H for acute inhalation.  Review the RPD types below and determine if the label lists the
       appropriate type based on the product description and toxicity category.. Please note
C.
D.
Precautionary Labeling
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Label Review Manual
                                           II             I
                                           Current as of December 27,1996
      A.
       B.
        D.
that if the registrant has submitted information to support the selection ofanothertype
of RPD which is more protective, allow the registrant to retain that RPD i^""ซ*
on the label under review. Information that could support an alternate RPD could be
the submission of the product vapor pressure indicating that the RPD specified m tiie
list below would not provide adequate protection or may pose an increased risk to the
user unnecessarily.                               .

       Gases Applied Outdoors:  Products that are formulated or applied as a gas
       (space and soilfumigants) and thatmay be applied outdoors must bear labeling
       specifying the following RPD requirements and statement:

             "Forhandling activities outdoors, use either a respirator with an
             organic-vapor-removhig cartridge with a prefflter approved for
             pesticides (MSHA/NIOSH approval number prefix TC-23C) or
            -. a canister approved for pesticides (MSHA/NIOSH approval
             number prefix TC-14G)."

       GaseousProductsUsedinEnclosedAreas: Products that are formulated or
       applied as a gas (space and soil fumigants) and that may be used in greenhouses
       or pther  enclosed areas must bear labeling specifying  the following RPD
       requirements and statement:

             "For handling .activities in enclosed areas, use either a supplied-air
             respirator with MSHA/NIOSH approval number prefix TC-19C, or a
             self-contained  breathing  apparatus (SCBA) with MSHA/NIOSH
             approval number TC-13F."
       C.
       Solid Products: Products that .are formulated and applied as solids must bear
       labeling specifying the Mowing RPD requirements and statement:
              "For handling  activities, use a dust/mist filtering  respirator
              (MSHA/NIOSH approval number prefix TC-21C)."
                    1 '"   '   '    ''   '.''•'  •' ''•!''  ••' ;'V:::'i "-'': '"' .'." : '•''•', ''' .'  '''  '' ' •• '  ."••"''•'•"•.V
        liquid Products in Toxicity Category I: Products that are formulated and
        applied asliquidsmustbearlabeling specifying thefoUowingRPDrequirements
        and statement:

              "For handling activities, use either a respirator with an organic-
              vapor-removhig cartridge withaprefilter approved for pesticides
                                                                                     :''
  Precautionary Labeling
                                                                        Page 8-16

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Labef Review Manual
Current as of December 27,1996
                  (MSHA/NIOSH approval number prefix TC-23C), of a canister
                  approved for pesticides (MSHA/NIOSH approval number prefix
                  14G)."

      E.    Liquid Products in Toxitity Category n: Products that are formulated or
            applied asliquids must bear labeling specifying the following RPD requirements
            and statement:

                  "For handling activities during [insert applicable terms based on
                  directions for use:  airblast, mistblower, pressure greater than 40
                  p.s.i. with fine droplets, smoke, mist, fog, aerosol or direct
                  overhead] exposures, wear either a respirator with an organic
               ' „' vapor-removing cartridge with a prefilter approved for pesticides
                  (MSHA/NIOSH approval number prefix TC-23C), or a canister
                  apprbvedforpestiddes(MSHA/NIOSHapprovalnumberprefix
                  14G).  For all other .exposures, wear a dust/mist filtering
                  respirator (MSHA/NIOSH approval number prefix TC-21G)."

9.     REQUIRED LOCATION FOR  PPE LABELING FOR APPLICATORS AND
      OTHER HANDLERS:  PPE statements for applicators and other handlers must
      appearin the "PRECAUTIONARY STATEMENTS" section of the labeling. Refer
      to PR Notice 93-7 Supplemeait 3-A, Part 1 Product Worksheet. All products subject to
      the WPS 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."

10.    LABELING AND PPE FOR EARLY REENTRY WORKERS - WPS Products

      A.    All products subject to the WPS must bear the following statements for workers
            who reenter the treated area prior to the expiration of the reentry interval:

                  "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, wear: (Insert all PPE
                  required for applicators and other handlers. Omit any respiratory
                  protective devices).
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                     Page 8-17

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Label Review Manual
                                                 Current as of December 27,1996
      B.
      C.
11.
            Additional  Early Reentry Worker PPE  Requirements:   The  following
            modifications must be made to the early reentry worker labeling and PPE
            required in Section A. above:

            ซ-    If the handler body clothing requirement is a long-sleeved shirt and long
                  pants, then the early-entry worker requirement shall be "coveralls."

            *r    If there is no handler requirement for or against gloves, then the early-
                  entry requirement shall be "waterproof gloves."

            Required Location forEarly-Reentry Worker Labeling and PPE Labeling: PPE
            statements for early-reentry workers must appear in the "DIRECTIONS FOR
            USE" section of the labeling under the heading "AGRICULTURAL USE
            REQUIREMENTS" immediately after the restricted-entry statement.
                               '     '''"'•.•  '••  i  '•'  f'J V";.;	V,v ; ';•" '': ":;/, :  ''' ';,;.!".',',::-!
      USER SAFETY RECOMMENDATIONS:  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. The preferred location for this box is at the end
      of the section headed "Hazards to Humans (and Domestic Animals).

First Aid (Statement of Practical Treatment)

      Afirst aid statement is requiredforeach route of exposure (oral, dermal, inhalation, eye
and skin) where the toxicity study has been classified as category I, H, or m. It is acceptable
for the registrant to include first aid statements (category m statements) for studies that are
classified as category IV.                .                                  .    '

1.    REQUIRED HEADER: Any of the following headings are acceptable:  First Aid,
      Statement of Practical Treatment or Practical Treatment. The heading "Antidote"
      cannot be used unless a specific antidote is recommended. The label should bear the
      heading which is most readily recognized by the intended users of the product. This
      determination will be made by the registrant

2.    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 be  appropriate  for all ages  or when
      necessary, should include distinctions between the treatments for different ages, i.e.,
      children vs. adults.  The first aid statements should be such that  any reasonably
Precautionary Labeling
                                                                       Page 8-18

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 Label Review Manual
                                           Current as of December 27,1996
 5.
6.
 competent individual could perform them. First aid statements should not include
 procedures which must be performed by medical personnel or require specialized
 equipment (See Note to Physician) section.

 If the product contains an organophosphate (i.e., an organophosphorus ester that
 inMbitscholinesterase)oranN-methylcarbamate(i.e.,anN-methylcarbamic acid ester
 that inhibits cbolinesterase), the appropriate term shall be shown in the First Aid
 statement.

 ORDER OF STATEMENTS: First aid statements should be organized so that the
 most severe routes of exposure as demonstrated by the toxicity category classification
 are listed first.

 REQUIRED LOCATION: First aid statements must appear on the front panel of the
 label for all products classified as toxicity category I for acute oral, acute dermal, or
 acute inhalation exposure (40 CFR 156.10(h)(l)(i)). First aid statements triggered by
 any other exposure classification may appear on the front, side or back panel of the
 product label. However, anytime first aid statements appear somewhere other than on
 the front panel, a referral statement such as "see side/back panel for first aid" must
 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, yet set apart or distinguishable from the other label text.

 FIRST  AID STATEMENTS  FOR  FUMIGANTS:  Refer to  PR Notice 84-5
(Reference: PR-84-05) and Registration Staridards/REDs.

FIRST AID STATEMENTS FOR ALL OTHER PRODUCTS: Review the following
sections to determine the appropriate first aid statements for each route of exposure.

A.    Acute Oral: Use the folio wing flow chart to determine the appropriate oral first
      aid statements. Please note that oral first aid statements are controversial and
      there are differing opinions within the medical community concerning whether
      emesis (vomiting) should be recommended. Until the Agency resolves this issue,
      in situations where the registrant has recommended an oral first aid statement
      that differs from those on the flowchart, instruct the registrant to modify the
      statement according to the flowchart or provide a justification for the use of the
      alternate statement.
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Label Review Manual
Current as of December 27,1996
                                                 i- . , ., |i:' ,	•  i, ,', ' ,   '.    ,    .•':•.'  " '"• i • '
                   If the registrant's justification indicates that the proposed first aid
             statement was based pnmedical staffevaluation of the product, let the registrant
             retain the proposed first aid statement as long as it meets the requirements set
             forth in "Content and Clarity of Statements" and does not involve the use of salt
             water for emesis (PR Notice 80-2 (Reference:  PR-80-02)).  If the registrant
             indicates that the statement was selected by simply referring to another product,
             request that the registrant revise the statement based on the flow chart.
Precautionary Labeling
                       Page 8-20

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        Label Review Manual
                                                                   Current as of December 27,1996
Is the active ingredient
zinc phosphide?
        i

        NO
Is the product tox
category I or n for
oral toxicity?   -
        1
        NO
        I
                         Determining the Acute Oral Exposure First Aid Statement

                          -ป.  YES   -  -   Use the following Statement:
                                                IF SWALLOWED: Immediately call a Poison Control Center or doctor,
                                                or transport the patient to the nearest hospital. Do not drink
                                                water. Do not administer any thing by mouth or make the patient  ,
                                                vomit unless advised to do so by a doctor."
                       -  -   YES   -   -  Use the below for "All other Products."
Is product corrosive
(pH<2or> 11.5) or
is product toxicity category
I or n for eye or dermal -
irritation?

        I
        NO
        1
                       -  -ป•  YES   •ป-  -ป  Use the following statement:
                                                IF SWALLOWED: Call a doctor or get medical attention. Do not
                                                induce vomiting or give anything by mouth to an unconscious person.   1
                                                Drink promptly a largequantity of milk, eggwhites, gelatin solution, or
                                                if these are not available, drink large quantities of water. Avoid alcohol."
Does the product
contain > 10%
petroleum distillates?
       NO
        i
                       -ป•  -*   YES   -   -  Use the following statement:
                                                IF SWALLOWED: Call a doctor or get medical attention. Do
                                                not induce vomiting. Do not give anything by mouth to an
                                                unconscious person. Avoid alcohol.
All other Products.
NOTE:  Products in tox
category IV for oral
toxicity, do not require
a first aid statement.
However, if the registrant
chooses, he may use either of
these statements on his label.
                      •*  •*   YES   -ป   -*  Use either of the following statements:
                                                IF SWALLOWED: Call a physician or Poison Control Center. Drink
                                                1 or 2 glasses of water and induce vomiting by touching back of
                                                throat with finger.  If person is unconscious, do not give any thing
                                                by mouth and do not induce vomiting.                  •

                                                           OR

                                                IF SWALLOWED: Call a physician or Poison Control Center. Drink
                                                1 or 2 glasses of water and induce vomiting by touching back of throat
                                                with finger, or if available by administering syrup of ipecac. If person
                                                is unconscious, do not give anything by mouth and do not induce vomiting.

MOTE: The criteria in this flowchart are listed in priority order, with the highest at the top. If you have a product/chemical that meets more than one criteria, me
the criteria that appears first on the chart. Do not use more than one criteria!
       Precautionary Labeling
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Current as of December 27,1996
   B. Acute Dermal and Primary Skin Irritation: Since both these studies focus on the dermal
      route of exposure, the first aid statements for these two studies can be combined when
      required for both studies. If a statement is required for both studies, use the first aid
      statement required for the acute dermal toxicity study if both studies are in the same
      acute toxicity or for the more severe acute toxicity category if the studies are in different
      acute toxicity categories.

                        Table 11 - Skin Irritation Statements
Toxicity Category
I
n
m
IV
Required First Aid Statement
IF ON SKIN: Wash with plenty of soap and water. Get medical
attention.
Same as above
IF ON SKIN: Wash with plenty of soap and water. Get medical
attention if irritation persists. ,
Statement not required. Registrant may use category in statements
if he chooses.
                       Table 12 - Dermal Toxicity Statements
First Aid Statement Based on Acute Dermal
Toxicity Study
Toxicity Category
I
n
m
IV
Required First Aid Statement
IF ON SKIN: Wash with plenty of soap and water. Get medical
attention!
Same as above
Same as above
Statement not required. Registrant may use category HI statements
if he chooses.
   C. Acute Inhalation: Selection of the first aid statement is straightforward and is based on
      the toxicity category assigned to the particular study.
Precautionary Labeling
                      Page 8-22

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 Label Review Manual
Current as of December 27,1996
                        Table 13 - Acute Inhalation Statements
Toxicity Category
I
n
m
IV
Required First Aid Statement
IF INHALED: Remove victim to fresh air. If not breathing, give
artificial respiration, preferably mouth-to-mouth. Get medical
attention
Same as above
Same as above.
Statement not required. Registrant may use category m statements
if he chooses.
    D. Primary Eye Irritation: Selection of first aid statement is straightforward and is based
       on the toxidty category assigned to the particular study.

                         Table 14 - Eye Irritation Statements
Toxicity Category
I
n
m
IV
, Required First Aid Statement
IF IN EYES: Hold eyelids open and flush with a steady, gentle
stream of water for 15 minutes. Get medical attention.
Same as above
IF IN EYES: Flush eyes with plenty of water. Call a physician if
irritation persists.
Statement not required. Registrant may use category m statements
if he chooses. . \
7. NOTE TO PHYSICIAN

   A. When Required: 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
      (Reference: PR-84-05) orreleyant Registration Standards for the "Note to Physician."
     • For all other products, we are currently requiring a "Note toPhysician" as specified hi
      the proposed rule for the following types of products:
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Label Review Manual
Current as of December 27,1996
      ซ• All products that are classified as toxicity category I.

      w Any product which is corrosive or classified as toxicity category I for eye or skin .
                                          V.' • • ' '.!"' ;• .  'ฃ:•' :' ,  ' "'. '''('•! .'' '
      MP Products that are in acute oral toxicity category III, and contain > 10% petroleum
      distillate.

      ซซ•  Any product that produces 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).

   B. Contents of Note:   The proposed rule does not provide specific notes to physicians
      except for corrosive and toxicity category I and II eye and skin irritants. The proposed
      rule 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.

   C.  Specific Note for Corrosive or Toxicity Category I Eye or Skin Irritants:

       Use the following Note to Physician:

                "Note to Physician: Probable mucosal damage may contraindicate the use
             ;  of gastric lavage."

   D.  Required Location: TheIINotetoPhysicianf'shouldbelocatedincloseproxunitytothe
       "First Aid Statement" but should be clearly distinguished from it. In other words, it
       should not be mixed in with the ''First Aid Statement" but should appear below the last
       first aid statement.
                                                 ,     -, y ,       •  ,    ,  ,
8. LABELING STATEMENTS FOR SPECIAL SITUATIONS
                        ...    .,:,.';      ,, , j-' ! ; 'r-^'f/^  .,' . y; :•;. .  ',':  '•'  '  ,•', '<,;>
   A.  Chemigation statement (PR Notice 93-7, Supplement 3, page 39)
Precautionary Labeling
                       Page 8-24

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 Label Review Manual
Current as of December 27,1996
    B. Soil incorporation/injection/seed treatment (PR Notice 93-7, Supplement 3, page 39)

    C. Engineering control statements (PR Notice 93-7, Supplement 3, page 50)

    D. ULV and LV Uses (PR Notice 93-7, Supplement 3, page 40)

 Optional Labeling and Deviations

    EPA will consider precautionary statements that deviate from the requirements of this
 chapter, provided they meet the conditions as described below:

 1.  USEDILUTIONS: Additional precautionary wording and first aid statements on the label
    are allowed on concentrated products that correspond with a use dilution of the product
    that is consistent with the product's directions for use.  EPA policy allows such labeling
    provided data are submitted to support such statements. Thepolicy provided guidelines for
    the submission and review of such data and for the content and placement of associated
    labeling (Reference: LP96-03).

    A. Data Requirements: All data and draft labeling for use dilution precautionary wording
       and first aid statements should be sent to the appropriate product manager with a
       request for pesticide amendment.

       Usedilution precautionary wording orfirstaidstatementstriggeredbysystemictoxicity
       (acute oral, dermal or inhalation toxicity) can be supported  by calculations. Most
       systemic toxicity categories span an order of magnitude (10-fold). Therefore, in most
       cases, if dilutions are an order of magnitude or more, except for category I, they will
       bump up at least one toxicity category.  For example, if the end product toxicity
       category is H  and it will be diluted 10-fold, the diluted product will be  at toxicity
       category III; if it is diluted  100-fold, it will be at toxicity category IV.

       Use dilution precautionary wording or first aid statements triggered by skin or eye
       irritation or dermal sensitization must be supported by new or cited studies. If another
       registered dilute product (such as a ready to use formulation) has acceptable data and
      is found similar to the concentrated product after it has been diluted, that data may be
       used to support revised labeling.

   B. Labeling Requirements: It is important to remember that it is not our intent to allow
      dual sets of precautionary statements and/or first aid statements on the label. Rather,
      we will allow  certain  "additional" statements that  are applicable to  the most
Precautionary Labeling
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Label Review Manual
Current as of December 27,1996
      concentrated use dilution only. These additional statements (triggered by the toxicity
      category of the use dilution) should be placed directly after the required statements for
      the concentrate. Following are some examples (in parentheses)of how use dilution
      labelmgshouldappearonproduct labeling: (actual use dilution statements will depend
      on data submitted).
                           ,  '.     ,     •    •"•' •    ,'1  ••  ' ,	,•,; •.'•,' .'••,'. ' •• •ซ'  ••,,.•  • '      i
          '     .;             .     -           .  ,.. • t   ;  ' i     -    :    i; -    f
      Precautionary Statements:

         "Causes substantial but temporary eye injury.  Do not get in eyes or on clothing.
         Wear goggles or face shield. Wash thoroughly with soap and water after handling.
         Remove contaminated clothing beforereuse. After product is diluted in accordance
          with the'directionsforuse, gogglesorface shieldare'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.

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 ^registrant desires to place precautionary labeling on suchaproduct,
   they may do so. To promote labeling consistency it is recommended that the registrant use
   precautionary statements triggered by  toxicity category m.  Registrants may propose
   alternate labeling which should be reviewed by precautionary labeling reviewers.
                 -  ;  '    •   • , . •:  •••  •  '  .•;  .   -I  :*:'.; ^:i.',,  ••'•';•::••}••'  ,-;'-.YU:•••;• ^;a
3. ME-TOO DEVIATIONS:  If a me-too product is citing a product that has optional
   precautionary statements on the label, such as 1. and/or 2. above, those statements are not
   required on the me-too if the acute results are available.  If you have any questions about
   the availability of the acute studies, check with the precautionary labeling reviewers.
       "'   •     " '      • '    ,  ..   ••''  ••  •••  ~  ; •    '-•[  ••'• .•w>.j!.11<  "• •'.!•'''-';'/•.'/. '.>•• -v  '•••'"•••'•:
4. OTHER DEVIATIONS:  Registrants may submit WPS and non-WPS precautionary
   labeling that differ from the requirements in this chapter.  Such requests must be supported
   by data (or substantive justification), which should be routed to precautionary labeling
   reviewers or the Chemistry and Exposure Branches (CB-I or II) (for PPE). For example,
   the statement "Do not remove contact lenses, if worn. Get immediate medical attention.",
   cannot be approved by the Agency without supporting data or rationale.
                                               '"  ,11 ,  I ..,,'.' I, ',  '','.',  I. ' '   .,'',,,.'  , i  • 	„' ' I'!1.
 Precautionary Labeling
                       Page 8-26

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 Label Review Manual
                          Current as of December 27,1996
 Chapter 9
ENVIRONMENTAL HAZARDS
 Introduction                                                  .

       The Environmental Hazards statement provides the precautionary language advising
 of the potential hazards 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 six basic acute toxicity studies performed
 on the technical grade of the active ingredient(s) in the formulation. These six studies are: (1)
 avian oral LDM (with mallard or bo bwhite), (2) avian dietary LC^ (mallard), (3) avian dietary
 LCyf (bobwhite  quail), (4) freshwater  fish LC^  (rainbow trout),  (5) freshwater fish LC^
, (bluegill sunfish), and (6) acute LC^ freshwater'invertebrates (Daphnia rnagna). The data
 generated from these studies support the wording for the Environmental Hazards statement.
 Review of the data is performed by the Ecological Effects and Environmental Fate and
 Groundwater Division who may also review any label text proposed  by the registrant to
 determine what statements are required.

 Reviewin the Statement        .
 1 .     DOES PRODUCT REQUIRE ENVIRONMENTAL HAZARD STATEMENT? The
       reviewer must first determine whether the use patterns on the label require  an
       Environmental Hazards Statement.  The use pattern of a pesticide helps determine the
       need for and the specific text of the Environmental Hazards section.  Generally, the
       label reviewer may conclude that all pesticides used outdoors must have the statement.
       The reviewer should  also look at the statement with  a critical eye towards  its
       applicability. Does it makes sense for the product? For example, a granular herbicide
       should not have a statement warning of potential spray drift problems since granular
       formulations are not "sprayed" arid are seldom associated with any "drift." Another,
       example is the case of ethylene. Given the low toxicity and exposure profile for the
       outdoor uses, the statement has been omitted for ethylene gas. If in doubt contact the
       environmental effects reviewer for appropriate wording.

       A.   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 ta,gs may also omit the statement. Ho wever, a domestic use
            product such as a dog dip may still require the statement since a potential for
            contamination of water exists from the use of a dip.
Environmental Hazards
                                                Page 9-1

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Label Review Manual
                                                 Current as of December 27,1996
2,
      B.     Manufacturing use products (MPs), although used indoors to formulate other
            products, require some Environmental Hazards text because MPs are highly
            concentrated and could pose a serious hazard if a spill occurred during
            transport.

      C.    All products labeled for use outdoors must have an Environmental Hazards
            statement.

      D     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 remainder of this chapter.

      STATEMENT LOCATION: The reviewer must check if the statement is in the
      appropriate location on the label, wim the correct heading. The Environmental Hazards
      section of the label should be located under the general heading "Precautionary
      Statements." Itmusihave the heading "Environmental Hazards" (not "Environmental
      Precautions," "Environmental Protections," or anything similar).
                         '  '•  I'"'-  '". ••••, '-'  ;"/  '. "'•' "J'l '>'  '^&tt.',','S\:/.::'!,:; *>.>'.*'?••.  •'•(&'•$$&%
3.     SUPPORT FOR STATEMENT: The text of the statement is then reviewed according
      to the type of action:

      A.   If the action represents a submission arbrnpanied fry data, the Ecological
            Effects and Environmental Fate and Groundwater Division will review the
            environmental hazards statements and recommend any necessary label changes
            as part of their data review. The reviewer must specify all requested changes in
            their response to the registrant.

            Ecological Effects and Enykonmental Fate and Groundwater  Division is
            responsible for reviewing data on all technical products and may also review
            data  associated  with end-use formulations.  This occurs when  an end-use
            formulation is suspected of being potentially harmful to the environment (for
            example, microencapsulated insecticides which are used on crops are potentially
            harmful to pollinators). Once Ecological Effects and Environmental Fate and
            Groundwater Division has reviewed any data,  the Environmental Hazards
             statement  is drafted and will be included in a Reregistration Eligibility
             Document (RED), or in the past, the Registration Standard. If the reviewer is
             working on a me-too application for registration (where another  similar
             formulationisakeadyregistered),theEnvkonmentdHazardsstatementshould
             be the same as currently registered products. If there are no similar products to
                                                                                    'sit'.
 Environmental Hazards
                                                                         ••••.  -'I'
                                                                         Page 9-2

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 Label Review Manual
Current as of December 27,1996
             compare the statement to, the application should be routed to Ecological Effects
             and Environmental Fate and Groundwater Division for their comments.
             Additionally, if a registrant wishes to amend the Environmental Hazards
             statement, Ecological Effects and Environmental Fate and  Groundwater
             Division may need to see the application.

       B.    If the submitted action has been determined to be ame-too submission (chapter
             4), the reviewer must make certain that the draft label bears all the statements
             that the cited label bears. Additionally, since the cited label may have some
         .    statements that are outdated and/or missing (required since  the label was
             accepted), check the required statements outlined in the rest of this chapter to
             make sure that both the cited label and the draft label reflect current Agency
             policy.                        "

             IMPORTANT:  If an error is discovered  in the  ENVIRONMENTAX
             HAZARDS section of the cited me-too label, the reviewer should take the time
             to write a letter  informing the registrant  of the error(s) and require
             correction/revision in a suitable tune frame, such as 30 days.  (If the error is
             minor in nature, it would be acceptable to allow the registrant to correct the
             error at the next printing of the label.)

4.     GENERAL STATEMENTS

       A.    All commercially applied products with directions for outdoor terrestrial uses
             must have the following statements in the  Environmental Hazards section:

                   "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 cleaning equipment or disposing of equipment
                   washwaters."
•/                   .              .                     '
             This statement should be preceded by "For terrestrial uses," if the product has
        '     terrestrial, forestry (except aerial application) and domestic outdoor uses in
             addition to aquatic sites. This revised statement would then nojt apply to other
             general use patterns — aquatic (e.g., mosquito larvicides or adulticides, aquatic
             herbicides, piscicides,  slimicides, etc.), greenhouse and indoor uses.

             Some BT products cirarently do not require the "Do not apply directly to water"
             statement.
Environmental Hazards
                       Page 9-3

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Label Review Manual
Current as of December 27,1996
      B.     For residential consumer products, the required statement is:
                                ''  •     '''..'•  il • - ,"  ' "': ''" '"i "''.•.': ' '.' •''  :_ I" "•'.' ".j:.1 i 'ซ' ' "
                   "Do not  apply  directly to water.  Do not contaminate water when
                   disposing of equipment washwaters or rinsate."

             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 an aerbsol spray for application to wasp or
             hornet nests, there would be no equipment used, and the statement regarding
             cleaning of equipment may be omitted.
                '        ,     .     '           .    •• ii   ' i1, •' •„  " r     ' ' •  .„ • '
      C.     Ground Water Label Advisories
                                  "'  •     'i    ' i •   ' 1 ' ! ' 'i ''   iif'd ''' '' ' , "" i''  '  'i, '  ,        t
             (1)    When Ecological Effects and Environmental Fate and Groundwater
                   Division decides that adequate data are available to 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; however:
                           •  ,       •'    •        ' ;,  j  ,".••!.'. •, •   ,    -            '  • '•
                   (a)    No detections are reported in ground water (for example, for a
                          new chemical) and

                   (b)    Field  dissipation results are not  available (for example, not
                          completed, judged inadequate or invalid).
                          •       •."-.'    "     ' '  i  .'''   '' ','' '.:.'' "  ,' '         ,  ': •  '  . •'•'•• • '-1
                   The following label language is appropriate:

                                      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."
 Environmental Hazards
                        Page 9-4

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Label Review Manual
Current as of December 27,1996
             (2)    When Ecological Effects and Environmental Fate and Groundwater
                   Division decides that adequate data are available to 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:

                   (a)    Detections  are reported in ground water (for example, in a
                         monitoring study conducted for registration, or contained in the
                         Pesticides in Ground Water DataBase) or

                   (b)    Field dissipation  results are available that confirm  that the
                         chemicalJeaches.
             "         •'            '"     '    'I-  .. '    '     '  •* "      '             '
                   The following label language is appropriate:

                                     Ground Water Advisory

                         "This 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."

      D.    The following statement is required when a pesticide intended for outdoor use
             contains an active ingredient which has a mammalian acute oral LD^ slOO
             mg/kg, an avian acute oral LD^ ฃ 100 mg/kg, or a subacute dietary LC^ ฃ 500
             ppm1:

                         "This pesticide is toxic to wildlife."

      E.     The following statement is required when a pesticide intended for outdoor use
            - contains an active ingredient with a fish acute LC^ <. I ppm:

                           "This pesticide is toxic to fish."
   1 This information will be found in submitted data, the RED, or the Registration
Standard.  It may not necessarily be available to the label reviewer, but helps you to
understand the origin of the statements.
Environmental Hazards
                       Page 9-5

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Label Review Manual
                     Current as of December 27,1996
       F.     If field studies or accident history, such asthe Federal Insecticide, Fungicide and
              Rodenticide Act (FIFRA)ง6(a)(2) reports, indicate thatuseof the pesticide may
              result in fatality to birds, fish or mammals, the following statement is required:

                    "This pesticide is extremely toxic to wildlife (fish)."

       G.     If a pesticide is used outdoors as a foliar application, especially to crops, and it
              is toxic to pollinating insects, a "Bee Hazard" warning must be included in the
              Environmental Hazards. Thefollowing table sets out the toxicity groupingsand
              required label, statements for honey bees:

                        Honey Bee Toxicity Groups and Cautions	•
     Product contains any active
     ingredient with acute LDj,, 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.
                n
      Product contains any active
     ingredient(s) with acute LDjo
          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.
                m
             All others.
   No bee caution required.
   No bee caution required.
 Environmental Hazards
                                                Page 9-6

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Label Review Manual
Current as of December 27,1996
      H.     For registered end-use products, technical products and other manufacturing use
             products, i.e. those used to formulate other products, a "point source discharge"
             is a possibility - where 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.  The following National Pollutant Discharge Elimination System
             (NPDES) statement (as outlined in Pesticide Regulation (PR) Notice 93-10
             (Reference: PR-93-10)) is required on such products:

                   "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
                   (NDPES) 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. Forguidancecontapt your State Water Board
                   or Regional Office of the EPA."
             "      '          -. -'     • " *        .                 ?
             Further, P.R. Notice 95-1 (Reference: PR-95-01) exempts certain 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 P.R. Notice 93-10. P.R. 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 (suchascooling 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).

             The exemption of certain containers from the labeling requirements of P.R.
             Notice 93-10 does not relieve a producer or user of such products from the
             requirements of the Clean Water Act or state or local requirements.
Environmental Hazards
                       Page 9-7

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Label Review Manual
Current as of (December 27,1996
      I.     If a pesticide product  contains directions for use in treating seed,  the
             Environmental Hazards section must include the following statements:
               i                   	• ..  ,f  .:  , •. I  ' • • '!''"„ i. ซ , >  ' : • , '-' '  ' :.	   .' V.'J V
                   "Exposed treated seed may be hazardous to birds and other wildlife.
                   Dispose of all excess treated seed and seed packaging by burial away
                   from bodies of water."

5.    CHEMICAL SPECIFIC STATEMENTS: Some Environmental Hazards statements
      are prepared specifically for certain chemicals (a.L's). Some of those are shown below.
       Always check with REFs or the Chemical Review Manager for the status of the RED
      for the chemical. If a RED has been issued, check the RED for any specific guidance
      for Environmental Hazards labeling.

      A.    Chlorpyrifos
      '"    '    '            ,      ' '  "       , ' ' , *    ' I' / "   ' ,'„ „! * ,'.''' ',:•,'' „:;"'„ • ป, „ I' • ' , i ,,,.,. ', " *.',,!•!',,,!(„ ,•,,;.'
                                ป ., "'  .     .•",'•  ,r.",  ,;, • • ; : t , •   , , • • •' ".,,.,"• , "J > ,  _ ,•„ ..vm,,,,,,:,, ''n,,,
                   'This pesticide is extremely toxic to fish and wildlife. 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 EUmination System (NDPES) 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 treatmentplant authority.
                   For guidance contact your State Water Board or Regional Office of the
                   EPA."  '     '       "  " '   ' ' '''.'''  ' •'•"•"•"'••• ' "' .""; """  •;'  "  ; "  ;'* '"•

             Non-Aquatic Use Sites (except cranberries)

                   "This pesticide is toxic to birds, fish and aquatic invertebrates. Birds
                 "  feedingintreatedareasmaybekmed. Clean up spilled product to reduce
                   exposure to wildlife.  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 cleaning equipment or disposing
                   of equipment washwaters."
 Environmental Hazards
                        Page 9-8

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Label Review Manual
Current as of December 27,1996
             Non-Aquatic Use Sites such as cranberries

                    "This pesticide is toxic to birds, fish and aquatic invertebrates.  Birds
                    feeding in treated areas may be killed.  Clean up spilled product to reduce
                    exposure to wildlife.  Drift and runoff may be hazardous to aquatic
                    organisms  in  neighboring areas.  Do  not contaminate water  when
                    disposing of equipment washwater or rinsate."

       B,    Dimethoate

                 /  "This pesticide 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 pesticide is toxic to wildlife and aquatic invertebrates. For
                    terrestrial uses, do not apply directly to water, to areas where
                    surface water is present or to intertidal areas below the mean high
                    water mark. Runoff from treated areas may be hazardous to
                    aquatic organisms in neighboring areas.  Do not contaminate
                    water by cleaning equipment or disposal of wastes."

       C.    Resmethrin labeled for mosquito abatement and pest control treatments at
             nonagricultural sites          .   -

                    "This pesticide is highly toxic to fish. Drift and runoff from treated sites
                    may be hazardous to fish in adjacent waters. Consult your State's Fish
                    and Wildlife agency before treating such waters. 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
                    cleaning of equipment or disposing of equipment washwaters."

       D.    For 2,4-D derivatives (listed below), the following is required on end-use labels:

                    "This product is toxic to fish. Drift or runoff may adversely affect fish
                    and nontarget plants:  Do not contaminate water by cleaning of
                   equipment or disposal of equipment washwaters. Do not apply directly
                  • to water, or to areas where surface water is present or to intertidal  areas
Environmental Hazards
                       Page 9-9

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Label Review Manual
                                     Current as of December 27,1996
       E.
      below the mean high water mark.  Do not contaminate water when
      cleaning of equipment or disposing of equipment washwaters."

Derivatives:
      N-oleyl-l,3-propylenediamine salt
      N,N-dimethyloleyl-Unoleylamine
      Butyl ester
      Butoxyethanol ester
      Propylene glycol butyl ether ester

For 2,4-D derivatives; dimethylamine and isooctyl ester, the following is
required                       -
                   "This product is toxic to aquatic invertebrates.  Drift or runoff may
                   adversely affect aquatic, invertebrates and nontarget plants.  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  cleaning  of  equipment  or  disposing of equipment
                   washwaters."
       F.    2,4-DP and MCPP require the following

                    "Drift or runoff may adversely affect nontarget plants. 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 cleaning  of equipment of  disposing of  equipment
                    washwaters."                             ,
                                         ,    t  _  f  • n  ,',,,(,  .   '   r   , „    '. ,"   ,   • ' '
                                   !    .'"','      .i   '  i • , i v      '           " ',    n'
       G     Atrazine should require the following statements should appear on all atrazine
              products. (Reference: LP90-1 and LP92-06) and are intended to reduce point-
              source ground water contamination and surface water contamination.
                    ป Atrazine can travel (seep or 'iM.
                    waterwmchmaybeusedasdrinkingwater: Atrazine has been found in
                    ground water. Users are advised not to apply atrazine to sandandloamy
                    sandsoilswherethewatertableCgroundwate^isclosetothesurfaceand
                    where  these soils are very permeable,  i.e., well-drained.  Your local
                    agricultural agencies can provide further information on the type of soil
                    in your area and the location of ground water.
  Environmental Hazards
                                                                         Page 9-10

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 Label Review Manual
Current as of December 27,1996
                    This product may not be mixed/loaded, or used within 50 ft. of all wells
                    including abandoned wells, drainage wells, and sink holes. Operations
                    that, involve mixing, loading, rinsing, or washing of this product into or
                    frompesticide handling or application equipment or containers within 50
                    ft. of any well are prohibited unless conducted on an impervious pad
                    constructed to withstand the weight of the heaviest load that may be
                    positioned on or moved across the pad. Such a pad shall be designed and
                    maintained to contain any product spill or equipment leaks, container or
                    equipment rinse or wash-water, and rain-water that may fall on the pad.
                    Surface water shall not be allowed to either flow over or from the pad,
                    which means the pad must be self-contained. The pad shall be sloped to
                    facilitate material removal.  An unroofed pad shall:be of sufficient
                    capacity to contain at a minimum 110% of the capacity of the largest
                    pesticide container or application equipment on the pad. A pad that is
                    covered by a roof of sufficient size to completely exclude precipitation
                    from contact with the pad shall have a minimum containment capacity
                    of 100% of the capacity of the largest pesticide container or application
                    equipment on the pad. Containment capacities as described above shall
                    be maintained at all times. The above-specified minimum containment
                    capacities do not apply to vehicles when delivering pesticide shipments
                    to the mixing/loading sites.

                    States may have in effect additional requirements regarding well-head
                    setbacks and operational area containment.

                    This product may not be mixed or loaded within 50 ft of intermittent
                    streams and rivers, natural or impounded lakes and reservoirs. This
                    product may not be applied aerially or by ground within 66 ft of the
                    points where field surface water runoff enters perennial or intermittent
                    streams and rivers or within 200 ft around natural or impounded lakes
                    and reservoirs. If this product is applied to highly credible land, the 66-
                    ft. buffer or setback from runoff entry points must be planted to crop,
                    seeded with grass, or other suitable crop.

                   This pesticide is toxic to aquatic invertebrates. Do not apply directly to
                   water, to areas where surface water is present, or to intertidal areas below
                   the mean high watermark. Do not apply when weather conditions favor
                   drift from treated areas.  Runoff and drift from treated areas may be
Environmental Hazards
                     Page 9-11

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Label Review Manual
Current as of December 27,1996
                  hazardous to aquatic  organisms  in  neighboring areas.   Do  not
                  contaminate water when disposing of equipment wash waters."

      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. Thelabelreviewershouldcoiisultwiththeproductmanager/teamleaderand
      Ecological Effects and Environmental Fate and Groundwater Division.
                                       .        .I   n  ' ' . ''  :   . .. I '   "
              if,
 Environmental Hazards
                       Page 9-12

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  Label Review Manual
                                                  Current as of December 27,1996
  Chapter 10
                    PHYSICAL OR CHEMICAL HAZARDS
  Introduction

        This chapter covers the Physical or Chemical Hazards statements that are required for
  certain pesticide products.  Such hazard statements include flammability, explosibility and
  precautions necessary when handling liquid products used around electrical equipment. In
  addition, there are special hazard statements for certain fumigants.

        The reviewer should look through the following sections to determine which are
  pertinent to the proposed label under review.
Placement of the "Physical
                                    Hazards" Statement
       Placement of the Physical or Chemical Hazards statement shall be immediately below
 the Environmental Hazards statement, which is located below the Precautionary Statements,
 Hazards to Humans & Domestic Animals. [Federal Register (FR) Notice Proposed Rule on
 Labeling Requirements, Vol. 49, No. 188, ง156.56, September 26, 1984 (LFR-04A-04J)]

 Labeling for Flammable PrnHiirt^

       Precautionary statements relating to flammability of a product arerequired on the label
 if the product meets the criteria shown below.  Review the following chart to determine the
 flammability statement that should be included on the proposed label

       Subdivision D (Product Chemistry) of the Pesticide Assessment Guidelines, (ง63-15)
 covers the  flash point and flame extension of a product.  The flash point is the lowest
 temperature at which a combustible liquid will give off a flammable vapor which will ignite the
 liquid. The flame extension test is required for aerosol products. The flame extension test is
 conducted by holding the aerosol can 6 inches from a flaine 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 in excess of 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 of extremely flammable. Flashback occurs when the flame is drawn
 back toward the aerosol can, by the stream of propellant.  This would indicate a highly
 flammable product.
Physical or Chemical Hazards
                                                                      Page 10-1

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Label Review Manual
                                            Current as of December 27,1996
       Theproduct'sflaShPointisshowninblock9ontheConfidentialStatementofFonnula
(CSF) and should be expressed in degrees Fahrenheit (ฐF); in addition, for aerosol products,
the registrant is required to report the results of the flame extension test and any positive
flashbacks. Thisrequirementdoesnotapplytoproductsthataretypicallyincombustible, such
as most dust or granular formulations, pellets/tablets (baits), impregnated materials, etc. It
block 9 on  the  CSF indicates  "not applicable or N/A", you may skip this  section  on
flammabih'ty.                                                       :
Flash Point
                                                    Required Text
   Flash potntal or below 20*F; if there
    U a flashback at any valve opening
   FlainpointaboveM'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.
   All other pressurized containers
                       Extremely flammable. Contents under pressure. Keep away from fire, sparks,
                       and heated surfaces. Do not puncture or incinerate container. Exposurcto
                       temperatures above 130*F may cause bursting.   >
                       Flammable. Contents under pressure. Keep away from heat, sparks, and open
                       flame. Do not puncture or incinerate container. Exposure to temperatures above
                       130'F may cause bursting.

                       Contents under pressure. Do not use or store near heat or open flame. Do not
                       puncture or incinerate container. Exposure to temperatures above 130*F may
                       cause bursting.           	_______—————
                           ^tamers ,
    Atorbdow20*F
    Above 20'F and not over 80'F
    Above 80"F and not over 150*F
    OverlSO'F
                        Extremely flammable. Keep away from fire, sparks, and heated surfaces.

                        Flammable. Keep away from beat and open flame.
                        Combustible. Do not use or store near heat or open flame.

                        No text required.
                                                                     [40CFR156.10(h)(2Xiii)]
 ซ•,    CAUTION, WARNING, DANGER (human hazard signal words) are
        NOT to be used in conjunction with the flammability statements.

 Criteria for Deration of >Jon-flammabilitv

        Certain  products  may  reflect  a claim of  non-flammability,  with  terms  like
 "non-flammable" or "non-flammable (gas, liquid, etc.)." If the draft label does not have any
 claim of non-flammability, skip this section.  However, if the proposed draft label has such a
 claim, the reviewer must check to see that the terms "Extremely Flammable" or "Hammable
 are not being used in the Physical  or Chemical Hazards section of the proposed label.
 Obviously, if dthertermsarebemgusedmthePAK^^                          theclaim

 Physical or Chemical Hazards

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 Label Review Manual
Current as of December 27,1996
 ofnon-flammability CAN NOT be used as well. If the proposed label reflects a non-flammable
 claim, it must meet the following criteria for non-flammability:

 1.     CRITERIA FOR DECLARING NON-FLAMMABILITY

       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 350ฐ F (177ฐ C).
             Refer to the CSF for the flash point.

       If you are unsure of whether the product meets the criteria for declaring non-
       flammability, route the label package for Product Chemistry Review in Registration
       Division for a determination.

 2.     NON-FLAMMABILITY LABELING STATEMENT AND PLACEMENT: The
       phrase "non-flammable" or "non-flammable gas" or "non-flammable liquid1*, etc., can
       appear as a sub-statement to the mgredient statement, or on a back or side panel. The
       phrase must not be highlighted or emphasized (such as inordinately large type size, or
       sharply contrasting color, etc.) so as to constitute a misleading safety claim.

 Labeling for Liquid Products UsedNearElectrical Equipment (Dielectric Breakdown Voltage)

       Someproductsraayposeashockhazard 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 could be used near electrical equipment.
 (40 CFR ง158.190(a)) If the proposed draft label is not a liquid, skip this section.  If the
 proposed label is for a liquid product, review the criteria below:

 1.     CRITERIA FOR DETERMINING1 THE REQUIREMENT OF THE SHOCK
       HAZARD STATEMENT;

       A.     The use directions may 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 breakdpwn voltage is less than 5,000 volts.
Physical or Chemical Hazards
                     Page 10-3

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Label Review Manual
Current as of December 27,1996
2.    SHOCK HAZARD LABELINGSTATEMENT ANDPLACEMENT: If theproduct
      meets the criteria above, the following statement must be shown under the heading
      "Physical or Chemical Hazards."

             Do not apply this product in or on electrical equipment due
             to the possibility of shock hazard.

      (Section 63-21 of Subdivision D, Product Chemistry, Pesticide Assessment Guidelines)

Labeling for F.xplosiveness Potential

      When data submitted in accordance with 40 CFR 158.120 demonstrate hazards of a
physical or chemical nature other than flammabilify (such as potentially explosive), appropriate
statements of hazard must be included on the label Such statements should address hazards
ofexplosiveness.

      Chemicals which require specific statements for explosibih'ty include:  sulfur dust,
carbon dust,  potassium nitrate, sodium nitrate and potassium chlorate.  If, based on your
review of the CSF, you believe the product might require labeling for explosibifity, route the
label package for product chemistry review for a determination.
Additional I^hel Statements for rertain Firniieants

       Forsomefumigant chemicals, statements of flammability or other physical or chemical
hazards are required. A couple of fumigants are highly flammable hi the liquid or vapor form.
The statements of flammability listed below for the following chemicals should be located on
thesidepanel under the heading "Physical or Chemical Hazards.1* (Reference: PR Notices 84-5
and85-6)     '       '          '    ,/    ...'  ,   ' ''•  '" '"'/ ' '.     ,     "   ''  ' •  ".'V'.

       Sodium and Calcium Cyanides
                    •  • •       •    •: •   •'.: •; •;•'  ;:-f; •.•-•'.•; #;;••'	>ฃ•>;••":;•••• '•'• •..•', ii .;*•: ••••;•.• u.
             "In the presence of moisture, highly poisonous gas (hydrogen cyanide) is
             formed."            , .  .'  ,  '  '    , \' ,'.  ''./. ,     '.'   ,  .," _•''./ ''  ' '.'.,.".'
                   ,       ^       _ ,      „      ,,,„,,  ,,„,, , i, |,i ,        ,   ^ ^   , i; i  ,, ,,,,,„ ^
                                  11 '  ,  : ป   ,'    I'1 n "  :  ;:"' '  '• ' •    ' , •' •'     „ li1  '" ' '• ' i I •'' „ .' * ป '
Warning SStatemmis about Mixing Certain Products
                                ',,,,,       i  ,   	    „.  H, i „   ,',',,.'    „ ,    '	,;, .
       Certaui products react with certain surfaces such as galvanized steel to form highly
combustible gas. Therefore, under the Directions for Use section, some product labels will
prohibit mixing, storing, orapplyuigthe product in galvanized steel orunlined steel containers.
This is acceptable, however, no toxicity signal word (Caution, Warning, or Danger) may be
 Physical or Chemical Hazards
                       Page 10-4

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 Label Review Manual
Current as of December 27,1996
 used with this information.  The registrant may use "Attention", "Note" or a similar word or
 phrase to alert the user. (Refer to chapter 11, Direction for Use for more information on this.)

 Requirement for Use of Fire Retardant

       Because of its combustion capability, all formulations of sodium chlorate must include
 an appropriate fire retardant chemical. Refer to chapter 6, Ingredient Statement, forplacement
 instructions of the required statement.                                ,

 Other physical/chemical ha.ya.rd statements

       When data submitted in accordance with ง 158.120 demonstrate hazards of a physical
 orchemical nature other than flammability orexplosiveness potential, appropriate statements
 of hazard must be included on the label. Such statements may address hazards of oxidizing or
 reducing capability, reactivity or corrosivity.
Physical or Chemical Hazards
                     Page 10-5

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 Labef Review Manual
                      Current as of December 27,1996
 Chapter 11
DIRECTIONS FOR USE
 Tntroduction                                                   .

       The "Directions for Use" section of a pesticide label must provide the necessary
 information to answer four major categories of questions regarding the use of the pesticide.
 These four questions are:

       1)    Why is the pesticide being used? For what pest(s) or problem?
       2)    Where is the pesticide applied? (where should it npl be applied?)
       3)    How is the pesticide applied? (what special precautions must the user take? how
             much should they use?)                "
       4)    When should the pesticide be applied?

 w    If these questions are adequately addressed the person likely to use (or supervise the use
       of) the pesticide should be able to do so correctly.
 •*    Directions for Use should be stated in terms which can be easily read and understood
       by the average person likely to use or to supervise the use of the pesticide.

 ซ•    Directions for Use should be presented in a format that is easy to understand and
       follow. Use of charts, and graphs is encouraged.  Long and/or complicated narrative
       instructions should be discouraged.
x            '           •           ,'','.>''
 •ป    The directions for use should, be adequate to protect thepublic from fraud and personal
       injury, and the environment from unreasonable adverse effects.

 *ป    Most misuse of pesticides results from failure of the applicator to read and understand
       or follow the directions for use. Therefore, this section of the label must be reviewed
       very carefully.            '

General Requirements

 1.     TITLE: The title of this section of the label must be "Directions for Use." Itmust not
       be "General Directions," "UseDirections," "How to Use," or any other similar wording.
Directions for Use
                                            Page 11-1

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Label Review Manual
                                           Current as of December 27,1996
2.
3.
The directions for use can be either on the container label or enclosed within the
packaging as long as the enclosure is attached securely and the container label makes
reference to the enclosure (40 CFR 156.10(i)).

GENERAL MISUSE STATEMENT: All registered pesticides, including all end-use,
technical grade, or manufacturing use products (MP's), must bear labeling which has
the following general misuse statement:

      "It is a violation of Federal law to use this product in a manner
      inconsistent with its labeling."
        , , ,                             ,   ,, „  , if  	  ,„,  „    ' „       	• , „ ~  	
This statement must appear immediately after the "Directions for Use" heading.

w    The general misuse statement should be moclified for Experimental Use Permits
      (EUPs), to read as follows:
                   "Use of this product in a manner inconsistent with the
                   terms of the Experimental Use Permit is a violation of
                   Federal Law."
OMISSION OFDIRECTIONS FOR USE: Thedirections for use section may actually
be emitted from the label for certain very specific types of products., If the pesticide is
amanufacturing use product (MP) intended only foruseby formulators preparing end-
use products, or if the pesticide is intended for use only by physicians, veterinarians or
pharmacists, the directions for use may be very limited.  This is acceptable, however,
MPs must have a statement under Direction for Use such as, "Only For Formulation
Into A [type of pesticide]." followed by a continued statement of the uses (crops/sites)
for which the EP could be registered. If the label under review is claimed to be for one
of these types of products, the label reviewer must verify the presence of the statement
as mentioned  above or  a statement about  use by physicians, veterinarians or
       N               '          , ' i  ' ; i'1,; ' I" " ill i '' i  i':|I||M !*,.' t '• ''  ' ;    '„!"'''   ',   '" l"11'1' :" ii,,i 'c\\'
pharmacists.

WORKER PROTECTION STANDARD:  Worker Protection Standard  (WPS)
Requirements  - refer to chapter 8 for the criteria necessary to determine if the label
under review is subject to the WPS requirements. If the product is subject to the WPS,
refer to the requirements listed at the end of this chapter.
            •             '   •       .     , •'. ih  , .  • hi1 ,  ' , j.  , .   . ' '    .       •  .1 'i . •
 Directions for Use
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Label Review Manual
Current as of December 27,1996
Type of Review

1.    ME-TOO APPLICATION: If the application is a me-too submission (chapter 4),
      reviewing the directions for use is fairly straight forward. A side-by-side comparison
      of the two sets of directions is made. The use sites and pests must be the same, although
      not all must be present on the pending application. In other words, the me-too label can
      drop) target pests of sites on the main label. For example, an application is made for
      an insecticide formulation to add structural perimeter treatments for crickets, ants, and
      sowbugs. The mam (cited) me-too product must have this site, and it's label miistclami
      crickets, ants, and sowbugs; but other species (earwigs, millipedes) also may be claimed.
      The pending submission need not have all the pests listed on the me-too label, however,
      no new use sites or pests may appear on the labeling for the pending product. The
      format for the presentation of use information need not be identical to the sited me-too
      as long as the critical information as described above remains the same.  In fact,
      registrants should be encouraged to adopt formats such as charts and graphs that are
      easier to read and understand.

            NOTICE:  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. If reviewers are not careful, such errors may be repeated, sometimes
            over and over.

   .   w    If an error is discovered in the directions for use of the cited me-too label, the
            reviewermust  take the time to write a letter informing theregistrant of the
            error(s) and require correction/revision in a suitable time frame such as 30 days.
            (If the errbris minor in nature, it would be acceptable to allow the registrant to
            correct the error at the next printing of the label.) This action may be entered
            into "Pesticide Regulatory Action Tracking System" (PRATS) under action code
            360, "Action Initiated by Agency" (see chapter 5). This is a judgment call, if an
            error is too minor to warrant this extra effort, it may be flagged and corrected
            during the review and response to a subsequent submission on the product, or
            during the reregistration process.   However, if the error raises  a  safety,
            environmental, or legal issue (i.e. conflict with current regulations or policies),
            the reviewer must require the registrant to correct the problem immediately.

      If a Reregistration Eligibility Decision (RED) has been issued for the active ingredient
      in the product undergoing review, the reviewer must ensure that all of the use sites on
      thelabelarein Appendix A of the RED and that any other limitations arenotexceeded.
      If any one of the use sites is not in Appendix A, it is considered to be "new" and the
      submission may not be considered to be a me-too.                           * -
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Label Review Manual
Current as of December 27,1996
2.    NON ME-TOO APPLICATION: When a Registrant proposes a new use, new
      application rate, preharvest interval (PHI) change, or a similar action not previously
      approved by the Agency, a more extensive review than the simple me-too comparison
      is necessary.  Such applications usually should be accompanied by data, or should
      include data citations, and should be sent for review. The directions for use will be
      affected by the reviews from Health Effects Division (HED) (use rates on crops, PHI's,
      reentry intervals),  Ecological Effects and Environmental  Fate, and Groundwater
      Division (EEEFGD) (for restrictions such as bee hazard warning statements), and
      Division Efficacy reviewers (for application rates and methods).  The use rate, or
      application rate, may be the most difficult to interpret and review for this section.
   ,   Application rates, andnumber of applications per season, foragricultural products, will
      be based on the residue data submitted or cited by the registrant Approval of most
      agricultural uses requires an established tolerance (tobacco oeing an exception).

      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. The reviewer must not
      assume that because a registrant is adding to or changing only one part of this section
      that the rest of the directions for use is "ok," even though the label has been accepted in
      the past. A number of years may pass between submissions on a product, some labels
      may be quite old (even asmuch as 20 years) and uses and language previously accepted
      may be objectionable now.. Reviewers must also examine use directions carefully for
      unannounced changes; changes made by the registrant that they did not tell us about.

Site, Pest. Application Analysis of the Label
      The Directions for Use section usually will be revised more frequently than any other
section of the label and should be carefully scrntiniTed by the label reviewer. The following
basic procedure should be applied to the review process for the directions for use.

1.    WHY IS THE PESTICIDE BEING USED:

             MT what is (are) the target pest(s)?

             MT' what is the crop, animal or use site the product is intended to protect?

             HP Is this an appropriate and Agency-accepted use of this pesticide?

      Target Pests may be invertebrates, vertebrates, nematodes, plants, algae, fungi, viruses
      or bacteria. The directions for use section of the label must identify the target pest(s)
      •and must be consistent with the pests mentioned elsewhere on the label. Pest claims
Directions for Use
                       Page 11-4

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Label Review Manual
Current as of December 27,1996
      often appear on the front panel. The reviewer must make sure that the directions
      for use actually include and are applicable to all pests listed anywhere on the
      labeling.  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.

      A product may be intended for a number of different pests, or directed at only one
      specificpest Frequently, there will be specific sets of application directions on the same
      label, each applying to one or several of the pests claimed on the label. Pests for which
      special or unique application techniques are needed (e.g. fire ants), will require their own
      detailed set of directions. It is acceptable to group directions according to the sites to
      be treated (e.g. broccoli, cabbage, cauliflower: cutworms, fall armyworms, cabbage
      loopers)  For fungicides, grouping may be used  ONLY if all pests occur and are
      controlled on all of the crops in the group. Diseases which occur on a single type of
      plant such as Black Spot on roses, must be associated with that particular plant.

      Target pests may be named very generally m the directions for use section of some labels
      (e.g. ants), other labels will identify them specifically, (e.g, carpenter ants). In the case
      of antimicrobial  products however, each strain of a pest has to have separate data for
      review so both the common and generic terms could  be used if appropriate.  For
      example, "Kills germs which cause common colds and flu" must be followed with the
      wording "such as" and list the flu germs controlled. The directions  for use should be
      determined by and reflect the biology and behavior of the pest as closely as possible.
      Some knowledge of the pest is helpful, and may in some  cases be critical.  However,
      comparison to similar product labels, as well as information from the PM/team leader,
      and eventual experience, will help the reviewer become more familiar with a pest's
      biology and behavior and therefore, with typical treatment techniques. Two important
      relationships to keep in mind while analyzing the target pests are:

      A.    Pest-Product  Formulation:  For  example, if the product  is a granular
             formulation, it will have no effect on a flying insect.  A liquid formulation
             restricted to foliar aerial application (like parathion) would be unlikely to
             control soil inhabiting insects such as corn rootworm larvae. If the reviewer is
             unsure of the practicality of a formulation as targeted against a certain pest on
             a label, the reviewer may need to consult with the efficacy reviewers in the
             branch. The registraiit must be informed that the  use is not acceptable. They
             may appeal by providing information (data) to persuade us that the formulation
             is in fact appropriate for the proposed use.

      B.     Pest-Site: the label may contain claims for control of a pest in an inappropriate
             site, misleading the consumer and possibly causing a misapplication of the
Directions for Use
                       Page 11-5

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Label Review Manual
                                                   Current as of December 27,1996
             pesticide. Examples of inappropriate pest/site claims are algae control in toilet
             bowls, or brown dog ticks in a commercial kitchens.  The registrant must be
             informed that such a claim is unacceptable.
      Sites and pests also should be appropriate for the intended end-user or customer of the
      product.  For example, pests and sites listed on the labels of residential consumer
      (general public) products should be typical household/garden pests or plants, and not
      something crop specific like cotton bollworm or plants unlikely to be found in home
      gardens, for example "cranberries."

             •*• "No Pest" Products: Several pesticides are not intended to control pests, i.e.
             they have no "target" pest. Examples are: plant regulators, desiccants  and
             defoliants.                 .     '        .,

2.    JWHERE IS THE PESTICIDE USED:

             ซr what are the intended use sites ofapplication?

            ., ซr, are the use sites clearly listed and identified?

      The application or treatment sites must be cleariy identified and specified as much as
      possible on the label. For example, if residential dwellings are listed as an application
      site, exactly where in a dwelling would the pesticide be applied? the label reviewer may
      need to inform  the registrant that the application sites need to be identified more
      specifically (as  for example, cracks  and crevices in kitchen areas  of residential
      dwellings). If the use site is indicated by a broad crop grouping, such as "Ornamentals",
      the registrant should be instructed to be more specific.  The use site could be indicated
      as, "Ornamentals:  Christmas tree plantings, conifer  seed orchards, arid forest tree
      nurseries," In this case, the product user would be restricted to only using the product
      on those three us& sites.  However, if a use site were indicated as "Non-cropland
      industrial sites, such as, airports, fence rows, roadsides and associated tights-of-ways,
      rauroadright-of-ways, lumberyards, petroleum taiik farms, pipelines and utility rights-
      of-ways, storage areas, and private lands.", then the user could use product on any thing
      known as non-cropland industrial sites. It is important for the label reviewer to analyze
      the proposed use sites of the label being reviewed to determine if the use sites are
      correctly listed and, more importantly, are the use sites appropriate for this product.
      Do the use sites make sense for this formulation and product type? Is it appropriate for
      the label to restrict use to only certain plants with the verbiage "including"? Is. the use
      of the verbiage "such as" appropriate  to give the user "some idea of what the use site
      means, but not restrict the user to only certain plants  (specific  sites)?
                                                                                    i1}!1,1,1"1'*
Directions for Use
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 Label Review Manual
Current as of December 27,1996
       Are the sites listed on an end-use product label compatible with the labeling of the
       manufacturing use product (MP) which is used as the source of the active ingredient in
       the formulation?  If the MP label does not specifically list acceptable sites (such as
       individually named crops), or general uses such as whether products formulated from
       it may be used indoors or outdoors, it should at least not prohibit uses appearing on the
       end-use labeling undergoing review. If this is the case, the registrant must be informed
       that they must change their source of the active ingredient to one with compatible
       labeling, or delete the questionable use.

       Often times it is very important to determine who the intended users of the product are;
       is the product primarily intended for use by general consumers or "homeowners"? For
       residential consumer-use products, the application sites listed on the label should be
       limited to the home,,yard, garden, and pets. Products intended for use by commercial
       applicators may include residential sites, but also industrial and institutional sites such
       as areas in food processing plants_and hospitals.

       When used in reference to the response of crops and weeds to the proposed pesticide
       product (e.g.,  an herbicide), use the  word "tolerant" instead  of  "resistant."   For
       example, the label would refer to the use of the product on herbicide to/era/tf crops, not
       herbicide resistant crops.  (Reference: LP96-19).

 3.     HOW IS THE PESTICIDE APPLIED:

             •* in what form is it applied?

             **• is it mixed, and if so, how?                                     .

           .  ป how much product is used? .

             ซ• is equipment necessary and if so, what type?

             ปis it compatible/not compatible with other products?

       First, the reviewer must identify what form the product is in (dry,  liquid, a gas or a
       fumigant).  This information is more readily apparent to the applicator than to a label
       reviewer.  If the product name does not identify the formulation (such as "Sevin™
       Dust"), the reviewer may have to search the label briefly to determine the formulation
       type, for example, by checking the net contents statement (gallon or pounds?),  by
       checking the Physical & Chemical Hazards section to see if the product is pressurized,
       or by looking at the container disposal instructions. Reference should also be made to
Directions for Use
                     Page 11-7

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Label Review Manual
Current as of December 27,1996
      the Confidential Statement of Formula (CSF) for the product. Column 15 of the CSF
      indicates the purpose of an ingredient in a formulation. If something is identified as a
      propellant in column 15, then the product is pressurized (an aerosol).  Dust and
      granular products will contain ingredients which are referred to as "carriers."  Liquid
      formulations will contain ingredients which may be identified as solvents, emulsifiers,
      and de-foamers. The product chemistry (if available, some very old registrations often
      do not have product chemistry data) will include the manufacturing process which also
      provides information on the formulation type.
                 i      iป  h "  '  ""    ''' '    '   '' 	'  •  •''  'I'  ' i' ' '•!	"' "' ' " * " h • "''  • ' '''" ''I ' ™ " '• • ''	v '  li  I J ป  • !*' •"'•!•' ซ|''i "i"
       Secondly, the reviewer should determine if the formulation is "ready-to-use" or a
       concentrate which requires mixing. Aerosols, dusts, baits, granules and some liquids
       are examples of ready-to-use formulations.  Formulations requiring mixing such as
       liquids which are referred to as concentrates, as well as wettable powders, must have
       direction for dilution. These directions should be reasonable, easily understood, and
       presented as obvious usable units of measure, Le.,.nol "add 2.678 ounces to a gallon."
       The units of measurement must be by weight for dry formulations (Ibs, oz.), or volume
       for liquids (pints, fl.pz.). One of the most frequent fabeling errors observed by the
       OfiiceofPesticideProgram(OPP) is the useofoz'Torliquids instead of"fl.oz." Metric
       units may be used in parentheses after the accepted units.

       Althoughnotstatedrntheregiuations(40
      ' on the) label must not call for more than the net contents of the package (Reference:
       LP96-07).       .    "     '   '  '   '       '  "'";_;"'  J	""'"rv"""""'"''".' _"''""""'	'"'"
       The label reviewermust examine the proposed label for ambiguous language. Thiskind
       of vague orunclear text can often befound hi the Dkections for Usesection of the label.
       For example, here is some language from an actual label's Direction for Use: "Mix V/z
       to 2 pints of (pesticide) in 100 gals, of water. Apply 100 to 200 gals, per acre depending
       on spray equipment and tree size." The ambiguity: What does the language "Apply 100
       to 200 gals per acre..." refer to, spray solution, or does the applicator simply add more
       water to the 100 gallon mix to cover larger trees?  If an applicator interpreted the
       directions in this way, only half of the dose would be applied.  Obviously, there is a
       more precise means of expressing the directions for dilution and application rate.
                                                                               •'v&i: iSivlv 'l	i
       Theclearest method of presenting directions for dilution may involve the use of achart
       ortable. Basically, the dilution directions should statemix''^ amount of pesticide with
       "X" amount of water (or oil) to achieve a'pardJciiUar''^!^^ such as a 1% emulsion.
       When percentages are included in application rates, it should be indicated whether
       percentages are by weight or volume and whether the percentage refers to the product
       or a.i., unless this is obvious from the labeling.
 Directions for Use
                       Page 11-8

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 Label Review Manual
Current as of December 27,1996
        Labels for agricultural  uses, nursery uses, uses on golf courses, sodfarms or in
        greenhouses must comply with PR Notice 87-1, 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). This PR Notice states that labels must
        include the statement, "Do not apply this product through any type of irrigation
        system." or include labeling statements regarding chemigation contained in the PR
        Notice. Refer to PR Notice 87-1 for appropriate chemigation statements.

        How the product is applied and whether special equipment is needed to mix and/or
        apply the product must be detailed hi this section. The application rate, (how much to
        apply per unit area) must also be stated. Agricultural products usually expressthe
        application rate as" pints/acre for liquid formulations, of pounds/acre for granulars.
        Forresidentiai cbnsumeruseproducts, theapplication rateshould beexpressedinmuch
       .smaller units, such as pounds/square feet since this is much more appropriate for the
        home garden or yard.  Additionally, if equipment is required to apply a product
        purchased by a residential consumer, it should be the common hardware store type,
        such as a spreader. The public generally does not have access to  (and does not use)
       fancy or specialized equipment. They also do not put out the quantities of pesticides
       that growers or pest control operators do and will not need or have equipment for
       handling large volumes of pesticide.
                                (i'             "          '           .;,''''
       As. mentioned above, labels which have directions for use instructing user to mix a spray
       solution should indicate the spray volume per acre or per unit area.  For some
       applications it is acceptable for the label to indicate something like, "apply sufficient
       volume for thorough coverage."  For dust applications of consumer products,  a
       statement such as "apply uniformly for thorough coverage of plant surfaces" may
       adequately substitute for a specific application rate.  For aerial applications, spray
       volumes must be stated. Note: Spreader settings may vary from product to product.
       Such changes in spreader settings are not usually considered significant.

4.     WHEN SHOULD THE PESTICIDE BE APPLIED:

       ซ• are there seasonal, time-of-day, or weather restrictions or limitations?

       •* does it stain? (so it should not be used around certain fabrics, papers or other
       materials)                                                             ,

       w is it phytotpxic (to some plants in the application area)?

       ซ• is it best to treat some pests at different times of the day, or in certain kinds of
       weather?
Directions for Use
                     Page 11-9

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Label Review Manual
Current as of December 27,1996
FTFRA Section 2fee)                                           ,

      Label reviewers should be aware of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) section 2(ee) which allows the applicator of a pesticide to apply the pesticide
under certain conditions not specified on the label.  These conditions are as follows:

      MT     a product may be applied at any dosage, concentration, or frequency less than
            . that specified on the label, unless the label specifically prohibits such an
             application,
      ซr     it may be applied against any target pest not listed on the label as long as the
             crop/animal/site is on the label, unless the Administrator has forbidden it,
      •ซ•     any method of application not specified on the label, and not forbidden by the
             label text, may be used, and
      HP     a pesticide may be mixed with a fertilizer if the label text does not prohibit it.

    •  NOTE: These provisions of the law do not relieve the registrant from the requirement
      of pro viding complete directions for use, they only clarify what is not considered misuse.
                                   e sense. A^y applicator, and esptJCialJy the
Review Instructions
                                                                                I! . I
             • ' ,  ,       '       .   ,   . " ,, ;',;. -,..'    j ii |ji 	]:J  ._;   '     '     i;       >   i i • i
      As the directions for use can be very complex, it is best to review this section step by
step,' starting with the first site/pest combination on the label, and going through the series of
review points, listed below.

1.    Is the formulation acceptable for this site/pest combination?

2.    Is the site appropriate for the pest? Is it included in Appendix A of the RED, if there
      is one for the active ingredient (a.i.)?
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                      Page 11-10

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Label Review Manual
Current as of December 27,1996
3.    Can you calculate the application rate? Is it acceptable (i.e. does it agree with the rates
      in the Registration Standard or RED (if one is available)?

4.    Is there a tolerance?                                       .

5.    Is the PHI (preharvest interval, i.e., the minimum amount of time allowed between the
      last application and the harvest of the crop) or PSI (pre-slaughter interval - for animals)
      correct?

6.    Is the application frequency acceptable? (i.e. within requirements for the tolerance,
      appropriate for controlling pests, etc.).

7.    Istherestrictedentryinterval(REI)appropriate?(refertotheWPSappendixattheend
      of the chapter)

8.    Is the timing of the applications acceptable? (i.e., pre-bloom?).

9.    Is the method of application appropriate?

10.   Is all required equipment identified/specified?

11.   Is the rate of application consistent with the packaging of the product? The directions
      for use should not call for more than the net contents of the product (Le.. if a granular
      product is packaged as a 1 pound unit, its application rate should not require 200
      pounds of product).

12.   If the product contains more than one active ingredient, are all the uses acceptable for
      all the actives? 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 on additional crops. If there is more than one a.i. and a RED
      is available for each, all sites on a label must be listed in each RED.

13.   If a RED has been issued for achemical contained in the subject product, are there any
      specific guidelines for label use instructions? Always check with the Reference Files
      System (REFs) or the Chemical Review Manager for the status of the RED for that
      chemical and  if a RED has been  issued, check for any specific guidance for use
      directions labeling.

14.   Are there any recent, applicable PR Notices that contain specific requirements for use
      directions for the product in review?  Always check the Label Policy Directory, the
Directions for Use
                     Page! 1-1.1

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Label Review Manual
                                                  Current as of December 27,1996
                                                                                i;.,	I', ,"].'!„ J :,;,•'',.'; i),,1,,,
                                                                                „ i	in'1 mil V': ii!.;' .i'.'i1	
15.
      Labeling Bulletin Boards or check with a Labeling Unit staff for recently issued PR
      Notices.  (Note: At the time of publication of this version of the Manual, PR Notices
      have been recently issued for products used for disinsection of aircraft; for termiticide
      products and for products used in pet care.) Always check with.LU staff on the status
      of any pending PR Notices before accepting labeling of products that could be affected.

      The agency is trying to discourage the use of long and complicated narrative directions
      for use. Is the above mfprmation presented so that it is easy to read and understand?
       Could the registrant make better use of charts, graphs or pictograms to convey this
      information more clearly?
                           '   •• . . ';" ' , ;,• . ;.V '.''.I        "                         j"
      Once the first site/pest combination is "analyzed," the procedure should be repeated for
each successive site/pest combination until all uses are reviewed. However, some of the review
points noted above do not apply for all pesticides. For example, most of these questions are
inappropriate for a dog collar that controls fleas (which has one "site" and very simple
directions). However, the basic question regarding use applies to all pesticides: Does the use
of the product make sense and will  the applicator  understand what to do with the
product?

      When answering the questions noted above, the reviewer should refer, as needed and
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 and if it is not superseded by a
RED), and, for new or revised uses, to any reviews from HED, EEEFGD, or Efficacy. The
Code of Federal Regulations, Title 40, should be consulted for published tolerances.

      The directions for use section can become very involved depending on the site and
biology of the pest. Also, individual Branches may have their own label requirements. Your
PM/team leader and fellow reviewers are your best sources of such specific information.
Worker Protection Standard
                                 Requirements
              ii                         ,,,  , ,,   , ,
      Chapter 8 provides the information necessary to determine whether the label under
review is subject to the requirements of the Worker Protection Standard (WPS). Products are
referred to as being "in scope" or "out of scope/not in scope." The following are the WPS
requirements for the Directions for Use section.  [40 CFR 156, Subpart K (156.200 - 212)]
Products Subject to the WPS Must Bear Labeling in the Four Sections Listed Below:
       1.   General Statements
       2.   Restricted Entry Interval (REI)

Directions for Use
                                                                       Page 11-12

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Label Review Manual
Current as of December 27,1996
      3.   Notification-to-workers Statements
      4.   Non-Agricultural Use Requirements
    label Reviewers; Se aware, fiatM ftbitae 93-11,,8upptemehi& provides guidance
1. ,    GENERAL STATEMENTS: The following statements must appear on all labels. See
      the sample AGRICULTURAL USE REQUIREMENTS Box at the end of this
      Chapter.
      '     *            ••'.-'''','                     '
            A.    "Do not appty 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."

            Statement Location Requirement:   Must appear near the beginning of* the
            Directions for Use section of the label and must appear above the box with the
            heading "AGRICULTURAL USE REQUIREMENTS."

            Do the use-directions of the end-use product permit wide-area 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 can
            not reasonably be avoided? Examples: applications for control of mosquitos,
            gypsymoths, or Mediterranean Fruit Flie.s." Then the statement should appear
            in a box with the heading; "Agricultural Use Requirements."

            B.     "For any requirements specific to your State or Tribe, consult the
                  agency responsible for pesticide regulation."

            Statement Location Requirement: Shouldappear after the heading "Directions
            forUse"andbeforetheAGRICULTURALUSEREQUIREMENTSbox. See
            the sample AGRICULTURAL USE REQUIREMENTS Box at the end of this
            chapter.
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                    Page 11-13

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Label Review Manual
                               Current as of December 27,1996
             C.    "Use this product only in accordance with its labeling and with
                   the Worker Protection Standard, 40 CFR part 170."

             Statement Location Requirement:  Must appear on the product label in a box
             under the heading "AGRICULTURAL USE R^QUiREMENTS." See the
             sample AGRICULTURAL USE REQUIREMENTS Box at the end of this
             chapter.'        ••     '      .  .      	"""'  ' ' "    "	•	
             D.
"This standard contains requirements for  the protection of
agricultural workers pn 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 (in this labeling)1 about
(use any of the following that are applicable)2 personal protective
equipment, restricted-entry interval, andnotification to workers."
             Statement Location Requirement:  Must appear on the product label in a box
             following  Statement B,  under  the  heading "AGRICUUrURAL  USE
             REQUIREMENTS."-    See  the  sample  AGRICULTURAL   USE
             REQUIIIEMENTS Box at the end of this chapter.
             Dr    "Refer to supplemental labeling entitled AGRICULTURAL USE
                   REQUIREMENTS in the DIRECTIONS FOR USE section of
                   the labeling for information about this standard."
              J',   •  •  '   •"  ..    :.    '   , ; ••• v  ,,•' >•>• L/":I; , f,'.,,; .  ,v,, •./ ,: ,:;..•„•;.;;•. '•••;<
             Special Note:  Statement No. D of. Dt can be used on the label.  If
             statement No. Dt is used on the label, then katement No. D must appear
             on supplemental labeling.
   '"The appropriate phrase must be used. When reviewing a label, the phrase "on the label" should be used.
When reviewing supplemental labeling, the phrase "in this labeling" should be used.         i

   ?Only relevant items should be included in statement (Example: If label does not require PPE, the phrase
"personal protective equipment" should not be included as part of Statement No. 3.)
             f •'
Directions for Use
                                                    Page 11-14

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 Label Review Manual
Current as of December 27, 1996
             Statement Location Requirement: Must appear on the product label in a box
       t      under the heading "AGRICULTURAL USE REQUIREMENTS" Following
             statement C add "Refer to supplemental labeling under "Agricultural Use
             Requirements" in the Directions for Use section (deleted text) for information
             about  this  standard."    See  the  sample   AGRICULTURAL  USE
             REQUIREMENTS Box at the end of this chapter.

2.     RESTRICTED ENTRY STATEMENTS:  All  product labeling  must display 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. Some labels
       may have several different REIs for different crops:      .        .

       ซ•     REI(s) for Fumigaints: Current REI(s) will be retained or at the time of
             registration, an REI will be determined on a case-by-case basis.

       ซ•     REIs determined by Subdivision KDati (158.390): REI(s)wUl be retained.

       ซ•     All Other REI(s): Follow the steps below.
                                             i          '       •' ,
SJep_L Identify Acute Toxicity Data to Be Used in Determining REI(s)
        •  '              ,  •       . - ~       '            i     /
       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 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.     Use the signal word of the registered manufacturing use product that is the source of the
       active ingredient which does not have any acute oral, acute dermal, eye irritation, or
       skin irritation data;*
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Label Review Manual
                              Current as of December 27,1996
5.     Use the signal word of the product under review if none of the above data is available
      on the active ingredient or if the active ingredient without data is not a registered

      manufacturing use product.
'When signal words are used to determine the toxicity category, the signal words correspond
to thefoUowingtoxicitycategories: DANGER=Category I; WARNING=Category II; and

CAUTION = Category HI and IV


The chart below provides examples of how the acute toxicity category is determined for

purposes of determining the REI.
     Sole a.i.
      a.i. #1
Acute dermal tox data
Eye irritation data
Acute dermal tox data
Eye irritation data
Skin irritation data
m
n
m
n
m
                                                                  n
      a.i. #2
Acute oral tox data
m
      a.i. #3
Signal word of registered MP
(source of a.i.)
 Directions for Use
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  Label Review Manual
Current as of December 27, 1996
 Sjฃp_2l Determine appropriate REI(s) using the chart below and note exceptions*:
          '-Most Severn Tax C&tegaty Uted *
              .  to Determine
  " Length of Reipibd RBI
   When the most severe tox category is III or TV
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 organophosphorus 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:

 ซ•    If any existing interim REI(s) which were established prior to 10/20/92 are longer than
       the REI(s) based on the table above, the existing interim REI(s) should be retained.

 w    If a product bears REI(s) for uses not subject to the WPS, that single REI should be
       retained and included in the "Non-Agricultural Use Requirements" box.  If multiple
       REI's exist follow instructions for multiple REI's below.

       EPA will permit registrants to reduce the WPS interim restricted entry intervals (REIs)
from 12 to 4 hours for certain low risk pesticides. Refer to PR Notice 95-3 (Reference: PR-95-
03) for the  list of active ingredients that are eligible for reduced interim WPS REIs.  An
updated list of the active ingredients can be found in document MLD-23. End-use products
(EP) containing active ingredients that appear on this list are to be evaluated using the criteria
stated below:
Directions for Use
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Label Review Manual
                                      Current as of December 27,1996
      1.
      2.
       3.
       4.
The active ingredient is in Toxicity category IH or IV based upon data for acute
dermal toxicity, acute inhalation toxicity, primary skin irritation, and primary
eye irritation. Acute oral toxicity data were used if no acute dermal data were
available.  If EPA lacked data on primary skin irritation, acute inhalation, or
primary eye irritation of the active ingredient, the Agency reviewed data on that
end-point for similar active ingredients (analogs), and excluded such active
ingredients from consideration for the reduced REI, if the analog is in Toxicity
Category I or n for that endpoint.

The active ingredient is not a dermal sensitizer (or in the case of biochemical and
microbial active ingredients, no known reports of hypersensitivity exist).

Theactive ingredient is not acholinesterase 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.

No known reproductive, .developmental, carcinogenic, or neurotbxic effects have
beenassociatedwiththeactiveingredient. If active ingredients did not have data
available for these chronic health effects, EPA considered data on appropriate
chemical and biological analogs. Active ingredients that have been classified as
carcinogenic in Category B (probable human carcinogen) or Category C with a
potency factor, Q* (possible human carcinogen, for which quantification of
potential riskis'considered appropriate), or are scheduled for the Health Effects
Division's Cancer Peer Review process, were omitted from consideration.
                                                                                  r'BiS'i!.!1;, 	I, Ml	
                                                      ,,'ซ>:;''!'•!<
             EPA does not possess incident information (illness or injuryreports) that are
             "definitely" or "probably" related to post-application exposures to the active
             ingredient.                             „
                        I      i      ,.',  "        ^            i
             Some active ingredients are not included in Unit IV because they have been the
             subject of areregistrationeligibility decision document (RED) which concluded
             that a 12 hour or longer REI was necessary to protect workers. Active
             ingredients with REIs established during the recent reregistration activities are
             NOT eligible for reduced REIs through the notification process.  Although a
             RED has been completed on Glyphosate, the REI for Glyphosate was set
             utilising end use product data, and hence, the Agency will add it to the active
             ingredient list.  However, the registrant for those end use products must meet
             criteria listed in Unit VI to be eligible for a 4 hour REI reduction. It should also
             be noted that WPS does not apply to pheromones used in insect traps.
 Directions for Use
                                                            Page 11-18

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 Label Review Manual
Current as of December 27,1996
       REI(s) Location  Requirement:   Must appear  in the box  with the heading
       "AGRICULTURAL USE REQUIREMENTS."

       REI(s) Format Requirement:  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 A. &
                   B. below)."

       A..    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."

       B.    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 orfollowed by the word "Restricted Entry Interval" or the
             letters "REI."

       C.    For 72 hr RET for organopfro^phorbus ester in arid areas (step 2, page 16), see
             example of Agricultural Use Requirement Box at the end of this chapter.

3.     NOTIFICATION-TO-WORKERS  STATEMENTS: A notification  to  workers
       statement is required if the  product meets the criteria below.

       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."

       All Other Products: Products which contain any active ingredient classified as toxicity
       category I based either on acute dermal toxicity data, skin irritation data, orthecriteria
       below shall bear the notification statement.
Directions for Use
                    Page 11-19

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Label Review Manual
Current as of December 27,1996
Siepl: Determine available data for toxicity category determination. Since acute dermal and
skin irritation data may not always be available, use the folio whig list to guide you in selecting
which data/signal word should be used for determining the acute toxicity category:
1.    Consider acute dermal and skin irritation data on all a.i.(s) in the product;

2.    If acute dermal data are missing for any a.L, consider acute oral data on that a.L in
      addition to the primary skin irritation data on the a.i.

3.    If acute oral and acute dermal data are missing for any a.L, consider the skin irritation
      data on the a.L;

4.    if the acute oral, acute demal, and to
      the signal word of the registered rnin^

5.    If none of the above data is available on any a.i. in the product, consider the signal word
      of the end-use product.

Sten2: If any data used in Step 1, No. 1-5 are toxieity category I or the equivalent signal word
of "DANGER", then a notification statement is required.

      Required Statement
   *           ,        ,':'.', " n" ,„    :,,•'''•  i'   • ''  '' "i1 " <||, :' ;,i'• 'i  "TUP'ir' 'n Hi''in'"" i !.j '"" ' ' '.'• '''' ,1' •'!. ":il" '•' • ซ'ซ'•* "• '*'"' ':'' ' '
                   "Notify workers ofthe application by warning them orally andby
                   posting warning signs at entrances to treated areas."

       Location  of  Statement:  All notification statements must be  located  in the
       pIRECtlONS FOR USE section in the box with the heading AGRICULTURAL
       USE REQUIREMENTS.

       If Notification is not Required: If notification is not required, the reviewer should make
       sure that the statement about notification to workers is absent from the Agricultural
       Use Requirements  box. For example
              .•:'„    ;  ,; .  ••    ;,  :•,   >.   .,;  ,;  ;,<  ,\;,, ;!l|i|:-,  ,; •••'* |iป|i)f ;,ป;,}; \i-,:-.\.•..<',* •.'•,:.• ',:'•>; ',;,,; ..•).•.'..,';;:;,; S'1^-:!,":;:^.'1;^'.'.^))!
                    "... It also contains specUic instructions and statements  pertaining to
                    statements on this label about personal protective equipment (PPE), and
                    the restricted-entry interval..."
 Directions for Use
                      Page 11-20

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Label Review Manual
Current as of December 27,1996
4.     NON-AGRICULTURAL USE REQUIREMENTS: If the label you are reviewing
      contains only uses within the scope of the WPS, you may skip this section.  If the label
      contains 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." This box may be placed anywhere in the Directions for Use section
      of the label after the Agricultural Use Requirements box. The following  statements.
      must be contained in the non-agricultural use requirements box:

                       "Non-Agricultural Use Requirements"
                  "The requirements in this box apply io uses of this product that
                  are NOT witliin 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."

      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."
Directions for Use
                     Page 11-21

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Label Review Manual
Current as of December 27,1996
         Sample AGRICULTURAL USE REQUIREMENTS Box
                               1         '!'• •       I

                            DIRECTIONS FOR USE
                                      ,  ',       i     '                    *
      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 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 within
       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 eyeweaf
       - chemical-resistant headgear

       Notify workers of the application by warning them orally and by posting
       warning signs at entrances to treated areas.
Directions for Use
                     Page 11-22

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 Label Review Manual
Current as of December 27,1996
 Chapter 12
                               LABELING CLAIMS
 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.

 General Claims
  '            '          ' •   '     ' '' '   .   •' • '
       40 CFR156.10 (a)(5) contains specific examples (shown below) of claims considered to
 be false or misleading. The Labeling Unit can provide guidance and insight (not approval) on
 acceptable claims that can be made on labels.  If a label reviewer is in doubt as to whether a
 claim or statement is false or misleading, he or she should consult the Labeling Unit before
 accepting such claim.                                  ,

 Types of false or misleading statements:
      . •          '     ,'                  •     ,       ป
 1.     A false or misleading statement concerning the composition of the product;

 2.     Afalseormisleadrngstal^entconcerarngtheef^^
       or device;

 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 any agency of the Federal Government;

6.     The name of a pesticide which contains two or more principal active ingredients if the
      name suggests cne or more but not all such principal active ingredients even though the
      names of the other ingredients are statedelsewhere in the labeling;
                                                                '-.'•',
7.     A true statement used in such a way as to give a false or misleading impression to the
      purchaser;
Labeling Claims
                     Page 12-1

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Label Review Manual
                                            Current as of December 27,1996
8.
9.
Label disclaimers which negate or detract from labeling statements required under the
Act and these regulations;
10.
Claims as to the safety of the pesticide or its ingredients, including statements such as
"safe," "nonpoisonous," "noninjurious," "harmless" or "nontoxic to humans and pets"
with or without such a qualifying phrase as "when used as directed"; and

 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"
Product Name
            '   "       '. f   „          ::     .1, ' ,   • -,  ••!!, !',, •• i1 , :••: „ „	' !•	 -• ,,,  ,,:  i ..i" 	n;1," • ' t . >, ^ r ,:„., i vii!".1!1!!.:""'.
       The name, brand, or trademark under which the pesticide product is sold shall appear
on the front panel of the label. 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
supplemental registration as an additional name pursuant to 40 CFR 152.132.

       Sometimes the product's name on the label can be construed as a claW The label
reviewer should scrutinize the product name to determine there is nothing false or misleading
about the produces name. General superlative terms such as "super," "superior," and "ultra"
are acceptable and no longer need to be qualified by the term "brand" in a product name.
However, this determination also does not allow terms orclaims like those listed in PR Notice
93-6 whichclearly imply heightened efficacy (e.g., "hospital strength," "professional strength,"
etc.) (Reference: LP95-30).             '""_'...
•r           '        ."         -     ",',',',,   ;!	', , ,:,;,,. „;' ,'  ,,  ,,'.,',,,' ;;   , , ;,'. (, , '  ,:,',„"'
       If a product falls within the scope of WPS and contains an organophosphate (U., an
organophosphorus ester that inhibits cholinesterase) or an N-methyl carbamate (i.e., an N-
methyl carbamic acidester that inhibits cholinesterase), thelabel shall indicate the termdirectly
under the Product Name and in the First Aid statement.    -
               i"      '          ,i    '    i          , I                       '•: •*",'' , ',:„  * •" 'I I 'lift i1"'1' ''••
       The exact same name cannot be used for different products by any one registrant. The
 product name must be sufficiently different to clearly distinguish one product from another.
 However, a supplemental distributor could use the same product name as the parent product.
 If a registrant wishes to change the name of a distributor product, they may do so by informing
 Labeling Claims
                                                                   Page 12-2

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 Label Review Manual
                                       Current as of December 27,1996
 the Agency with a letter requesting cancellation of the old distributor name and filing a new
 Notice of Supplemental Distribution form (EPA Form 8570-5) showing the new name.
 Warranty Statement                                             .

       Warranty statements contain language intended to limit liability, or act as disclaimers
 or warranties for the product. Generally, we don't concern ourselves too much about these
 statements, however there are three generally recognizable types of unacceptable label language
 associated with disclaimers, warranties and limitations of liability are as follows:

       a.     Broad statements detracting from use instructions of other label language. (i.e.,
              precautionary statements);

       b.     Label language asserting that the buyer has accepted the manufacturer's
              statement of his respective rights. (i.e., manufacturer states buyer's rights are
              extremely limited);
       c.
Over-broad language implying buyer has no legal right to recover damages from
manufacturer.
       A part of any label review should be a examination of the proposed label's
 warranty/disclaimer/liability limitation language for statements (like those above) which appear
 to negate or detract from use instructions or other legal language. At the very least, the label
 reviewer should make sure that the  disclaimer statement makes it clear that it is the
 manufacturer's warranty disclaimer, by using such statements like "To the extent permitted
 by law, manufacturer shall not be liable...".

       When alabel revieweris in doubt asto the acceptability of any Warranty Statement, the
 statement should be referred to OGC. Contact the Labeling Unit for the correct procedure for
 doing this.

 Efficacy Related Claims

       Efficacy data (also referred to as product performance data) generally are only required
 to be submitted for products claiming to control pests which pose a threat to human health,
 either by direct action or through transmission of diseases (40 Code of Federal Regulations
 (CFR) 158.640).
Labeling Claims
                                                            Page 12-3

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Label Review Manual
Current as of December 27,1996
      Efficacy data are generated by studies designed to document how candidate pesticide
formulations perform as pest control agents. These studies include tests run to determine the
lethality of a formulation against a certain pest species, to document control under actual use
situations, and to determine whether claims beyond mere control are supported (i.e., length of
a residual effect).

      The Agency has standard protocols for certain efficacy tests.  In general, standard
methods have been developed for tests needed to substantiate claims that have been made
frequently forpesticide products. As the scopeofpotentialpesticidalclaimsis extremely broad,
the Agency does not have standard methods for tests needed to substantiate many of these
claims,  especially those that  are uncommon.  The Product Performance Guidelines,
Subdivision G, offer general guidance for developing protocols for efficacy testing. Proposed
protocols should be submitted to the Agency for review before tests are initiated.

      ซr    Important: Although the Agency does not require submission of efficacy data
             (except for the types of products listed below), the applicant or registrant is
             required to have .such data on hand. 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.  For example; a 2,4-D product
             that claims control of weeds in lawns for one full year or a cotton insecticide that
             claims total season-long elimination of pink bollworm with just one application.
             When the reviewer spots such suspicious claims, the pM/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. InCeases where such data have
             been required, the applicant often withdraws the application or submits revised
            : labeling deleting the claims.
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Label Review Manual
Current as of December 27,1996
Products Requiring Submission of Efficacy Data

1.     Disinfectants - All products (excluding those which are recommended for use in or on
       living man or animals) intended to control microorganisms infectious to man.

2.     In vertebrate 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 the above as well as termites, wasps, scorpions, poisonous spiders,
       fire ants, cockroaches, centipedes and bedbugs.

3.     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, products used to control vertebrate animals such as
       poisonous snakes, dogs, and bears that can injure humans by direct attacks.

4.     Potential Hazards -  Those products that are potentially very hazardous, and for which
       the Agency determines that it is necessary to conduct a "risk-benefits" analysis.

5.     New Actives or New Uses -.Formulated products which either contain new active
       ingredients or have proposed use patterns which differ greatly from any previously
       accepted for a similar fontiulation, and which may have public health uses.

6.     Products to Control'Mycotoxin Producing Organisms - Products intended to control
       organisms that produce mycotoxins (organic compounds produced by the fungus
       Aspergillus flavus which are highly toxic and carcinogenic to mammals).  No such
   '"•   products are currently registered.

Label Reviewer's Role
                                                                               !
       Within the Office of Pesticide Programs, product performance data is specific to and
evaluated by the three product Divisions: Antimicrobial Division (AD), Registration Division
(RD), and Biopesticides and Pollution Prevention Division (BPPD).

       The former Antimicrobial Products Branch (APB) in  RD has developed guidance
documents called DIS/TSS enclosures for the review of antimicrobial pesticides, including
determination of health-related and non-health-related issues (Reference: DIS/TSS-16) and
label requirements. Efficacy issues including label review are handled by the Risk Assessment
Labeling Claims
                      Page 12-5

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Label Review Manual
Current as of December 27,1996
and Science Support Branch.  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.

       Within the Fungicide and Herbicide Branches in RD, requiring efficacy data is not
generally an issue as the target pests seldom affect human health. Specific claims are evaluated
by the Technical Review Branch in RD. Insecticide Branch routes insecticide efficacy reviews
to technical reviewers on the Branch's staff for evaluation. Rodenticide efficacy data are
reviewed specifically by a Rodenticide staff member.
       Within the Biopesticides and Pollution Prevention Division (BPPD), there are no
product management teams, and the division is multidisciplinary, 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 two teams, one
"which handles science reviews, and one which handles the regulatory actions. The regulatory
team is comprised of Regulatory Action Leaders (RALs), and the science team is comprised
of science reviewers (SRs). General kbel review is the responsibiUty of theRAL, although SRs
are expected to review their appropriate sections (precautionary labeling, declaration of active
ingredients, storage and disposal, etc.).  Each team has a team leader (STL or RTL). Since
BPPD is multidisciplinary, many RALs are scientists that do science reviews, and many SRs
have regulatory experience and do regulatory actions. For this reason, product performance
reviewers may be located anywhere in the division.
                       ;•;.  ,,; . • - • ,• ; •             J|_     _   ,,             I     '
       In order to appropriately track product performance reviews in a multidisciplinary
division, the RAL gives the submission to the appropriate STL for assignment. The STL then
assigns the review to a scientist trained in the subject discipline (plant pathology, entomology,
etc.). That scientist could be either an SR or another RAL.  When completed, the evaluation
gets a peer review and goes back through the. STL to the original RAL.

       The following points should be kept in mind when reviewing labels bearing public health
efficacy claims:

       ซ•    Ambiguous and generic claims of efficacy such  as "kills germs" are riot
             acceptable.
             Implied claims {e.g., any statement, design, graphic representation or brand
             name) of heightened efficacy of a pesticideproduct by itself or as compared with
             another product or device are false and misleading.  Examples of such claims
             include, butarenotlimitedto: "professional strength," "extermination strength,"
 Labeling Claims
                       Page 12-6

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 Label Review Manual
Current as of December 27,1996
              "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).

              This policy does not apply to:

              •      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." However, such claims may not be exaggerated or used
                    in a way that would make them misleading.

              •      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. For example, "hospital use" may
                    be acceptable as long as it is not used in the product name or highlighted
                    on the label to the exclusion of other acceptable use sites.
                    -,".••        " •          "    *".-"'''''•
              •      Terms which describe a specific level of efficacy and which are standard
                    EPA-accepted claims such as "bacteriostatic," "sanitizer," "disinfectant"
                    and ^sterilant."                    ,

              Slime and odor control agents and other products expressly claiming control of
              microorganisms of economic or aesthetic significance are not considered to be
              human health related, but should bear accurate labeling claims. The product can
              be labeled only as a limited disinfectant for killing odor causing bacteria and/or
              fungi (e.g.,  mold  and mildew) in those areas or  on  those sites where
             microorganisms  normally cause odor.   The label  should bear one of the
             following statements: "Limited Disinfectant to Combat Odors Caused by
             Bacteria: or "Limited Disinfectant  Against Odor Causing Bacteria" (Draft
             Pesticide Assessment Guidelines Subdivision  H,  Labeling  Guidelines  for
             Pesticide Use Directions ). 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 (Message Log #7,6/27/96).

             Use directions should be clear and easily understood by the applicator

             Check with the efficacy reviewers if the label makes unusual claims, deviates
             from a standard use pattern, or if the formulation changes (minor formulation
Labeling Claims
                     Page 12-7

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Label Review Manual
Current as of December 27,1996
            changes in an antimicrobial 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.
                       %                .   •      !.•...''.'
            Do not allow any claim that would render the product rnisbranded under the
            Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and 40 CFR part
            156.10(a)(5).
Labeling Claims
                                                                       Paeel2-8

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 Label Review Manual
                        Current as of December 27,1996
 Chapter 13
STORAGE AND DISPOSAL
 Introduction                                                  .

       .All pesticide products are required to bear instructions for the storage and disposal
 of pesticides and pesticide containers. 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,,

 Statement Location

       The storage and disposal instructions must appear grouped together, preferably
 blocked, near the beginning or end of the "Directions for Use" section (40 Code of Federal
 Regulations (CFR) 156.10 (2)(ix) (MLD-11)).  It is preferred that the storage and disposal
 instructions appear at the end of the use direction section.  This placement eliminates the
 break between the heading "Directions for Use" and the body  of the use directions.
                                               <     _                  i.      •
 Format         -                                                 ,

       All products, except produces labeled for home and garden use by homeowners,
 must bear the heading "STORAGE AND DISPOSAL." However, the heading is
 recommended for homeowner products to assist in locating these instructions. The terms
 "household," "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. Blocking these
 statements with a solid line is suggested as a means of increasing their prominence. See
 example below:
                            STORAGE AND DISPOSAL

             Do not contaminate water, food, or feed by storage and disposal.

             Pesticide Storage....
             Pesticide Disposal...
             Container Disposal...
Storage and Disposal
                                             Page 13-1

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r
            Label Review Manual
                                                Current as of December 27,1996
            Typa Size Requirement

                  The heading "STORAGE AND DISPOSAL" must appear in the specific type size
            requirement as stated in Pesticide Regulation (PR) Notice 83-3 (Refence: PR-83-03).
                                          Required type size for the leading
                                                 and piffT™"^ all capitals
      Size of label front
      panel in square inches
      0 and under	 6 point
   .   Above 10 to 15 .		• • 8 point      |  ' ^ \  ^''  ~  '  ^' _	_ ^     '" ;,L
      Above 15 to 30	'.'..'	10 point
      Over30 .'...*	..••• 12 point

ftetermining Storage and Disposal Labeling
         "      !' '.•••,•'•,              I      ' I     II'     I
1.     PESTICIDE STORAGE STATEMENTS: Review the information below to
       determine the appropriate document to use as the source of pesticide storage
      .statements.        '       	'      	^'^.^  	ii]rii'    i  '	  •    ,	m_

       A.    RECENT Registration Standard or Reregistration Eligibility Document
             (RED): If a Registration Standard or RED exists, and is more recent than
             PR notices 84-1 (PR-84-01) (issued 2/17/84) or 84-5 (PR-84-05) (issued
             11/15/84), refer to the Registration Standard or RED to determine whether
             there are specifically required storage statements.  If the Registration
             Standard or RED does not contain storage statements, use the general
             guidance contained in this section under B. 3. Storage Guidance from PR
             Notice 83-3.

       B.    QJd/No Registration Standard or NO RED: If there is no Registration
             Standard or RED, or if the Registration Standard is older than PR Notices
             84-1 or 84-5 (see dates above), review one through three below to determine
             the appropriate document to use as the source of the pesticide storage
             statements.
                         (1)
                   Statements for Specific Chemicals: PR Notice 84-1 and an errata
                   sheet dated 4/12/84 contain specific storage statements for the active
                   ingredients listedfin.theTable 1 below:
             Storage and Disposal
                                                                       Page 13-2

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Label Review Manual
Current as of December 27,1996
                                     Table 1
Active Ingredient
Aspon
Aluminum phosphide
Ethoxyquin
Liquid Sodium
hypochlorite : .
Liquid Calcium
hypochlorite
Magnesium phosphide
Solid Calcium hypochlorite
Terrazole
Zinc phosphide
Pesticide Storage Statements
Label must be modified to include a warning against transporting or
storage in unlined steel containers.
The following statement must be used in addition to the guidance in
PR Notice 83-3: "Not for use or storage in or around inhabited areas."
The following statement must be used in addition to the guidance in >
PR Notice 83-3: "Open dumping is prohibited."
"Store this product hi 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."
The following statement must 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."
"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, of
cleaning of equipment." •
All manufacturing use products must contain the statement,. "This
product is corrosive to steel and many other metals. Do not transport
or store in unlined metal containers.'1
The following statement must be used in addition to the guidance hi
PR Notice 83-3: "Store in a dry place. Do not store around the home."
             (2)    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;
                   calcium and sodium cyanide; ethylene oxide; sulfuryl fluoride;
                   ethylene dichlpride; carbon tetrachloride; carbon disulfide; mixtures
                   of carbon tetrachloride and carbon disulfide; and mixtures of carbon
Storage and Disposal
                      Page 13-3

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Label Review Manual
                        Current as of December 27,1996
                    tetrachloride and ethylene dichloride.  For all other fumigants, refer
                    to number 3 below (Storage Guidance from PR Notice 83-3).

             (3)     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 meets the
                    requirements of PR Notice 83-3 Section I"(A).
             „          ,    ,'"','  ill . ',,"•, i, ,• .'  i1' ,' •'|i • , ii ih jir	 'in 'ซ •'/ j'"; I't1'1, /i'r'i'.i,, ',''',                  i
               /            ;. '        • • • 'n ,,. i. *   '  • i '„ '"• [ "i"' ''	"• , '' lif'ii,.; 'l'!',,r'iiir'' ! ,il i i H
                    All product labels are required to have appropriate storage
                    instructions. Specific storage instructions are not prescribed. Each
                    registrant must develop his own storage instructions considering,
                    when applicable,  the following factors:

                    •r     Conditions of storage that might alter the composition or
                           usefulness of the pesticide.  Examples could be temperature
                           extremes,  excessive moisture or humidity, heat, sunlight,
               :       ,  ;i •  ', •   , „   ".  ,,';,.., f,, ",,„,'„ '•',; ;,,',, !!i," •i ',!V',,, i;, RI v ,i,""i „',„!': '  , 
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 Label Review Manual
Current as of December 27,1996
                           storage to prevent cross-contamination of other pesticides,,
                           fertilizer, food, and feed.

                           General storage instructions for household products should
                           emphasize storage in original container and placement in
                           locked storage areas.
2.      PESTICIDE DISPOSAL STATEMENTS: The label of all pesticide products
        excluding those products labeled specifically for homeowner use are required to
        bear pesticide disposal statements.

        A.   General Statement:  All products, except those labeled for household or
             domestic use only, must bear the following statement:
                '      . '     '•.'/'~       '   '     '    .          •
                    "Do not contaminate water, food, or feed by storage and disposal."

             This statement should appear immediately under the heading "Storage and
             Disposal." (Reference: LP86-01)

        B.    Other Pesticide Disposal Statements: Review number one and two below to
             determine the appropriate document to use as the source of the pesticide
             disposal statements.

             (1)    Registration Standard or RED Issued After 2/12/86. If the label
                    under review involves a chemical for which a Registration Standard
                    or RED was issued after 2/12/86, refer to the Registration Standard
                    or RED to determine if any specific pesticide disposal statements
                    exists. If no specific guidance exists, refer to  in this section under (2.)
                    below to determine the appropriate pesticide disposal statement.

             (2)    Registration  Standard or RED Issued before 2/12/86. If the label
                    under review involves a chemical for which a Registration Standard
                    or RED was issued before 2/12/86, select the appropriate pesticide
                    disposal statement.

                    •     Except those products intended solely for domestic use, the
                          labels of all products that contain active ingredients that are
                          Acute Hazardous Wastes or are assigned to Toxicity Category
Storage and Disposal
                      Page 13-5

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Label Review Manual
Current as of December 27,1996
                          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 must bear the following pesticide disposal
                          statement:
                                "Pesticid^ 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.
                          The labels of all products, except those intended for domestic
                          Use, containing active or inert ingredients that are Toxic
                          Hazardous Wastes or meet any of the criteria in 40 CFR 261,
                          Subpart C for a hazardous waste must bear the following
                          pesticide disposal statement:

                                "Pesticide wastes are toxic. Improper disposal of excess
                                pesticide, spray mixture, or rinsate is a violation of
                                Federal Law. If these wastes'cannot be disposed of by
                                the use according toI label uistructions, contact your
                                State Pesticide or Environmental Control Agency, or
                             •' •.  the HaaKa^^'^a^^ep^^^^ at the neares
                                Regional Office for guidance."
                                              t    i      I  I
                          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."

                          Labels for all other products, except those intended for
                          domestic use, must bear tlie following pesticide disposal
                          statement:
 Storage and Disposal
                       Page 13-6

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 Label Review Manual
Current as of December 27,1996
                                 "Wastes resulting from the use of, this product may be
                                 disposed of on site or at an approved waste disposal
                                 facility." (Reference: LP86-01).

                    ซ      Labels for household pesticides must bear the following
                           disposal statement: "Securely wrap original container in
                           several layers of newspaper and discard in trash." (Reference:
                           LP86-01)

                           Note: This is identical to one of the statements allowed for
                           disposal of household pesticide containers.. In other words,
                           the same statement could serve as disposal instructions for the
           -                pesticide and the container.                .
                           • >     '   '   '  '     "     \                  •''.-'•     '    •'
        C.    Specific Pesticide Disposal Statements: (Reference: LP96-08))

                           "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
   L                        federal regulations.  If these materials cannot be used
                           according to label instructions or cannot be returned and must
                           be disposed, contact State Environmental Control Agency or
                           the Hazardous Waste representative at the nearest EPA
                           Regional Office for disposal guidance."

3.     CONTAINER DISPOSAL STATEMENTS: All pesticide products, including
       homeowner products, must bear container disposal statements which are specific
       for each type of container. PR Notice 94-02 allows registrants, at their discretion,
       to use alternate container disposal statements permitting the recycling of empty
       aerosol pesticide containers.  The alternate statements must specifythat containers
       be emptied through normal use and that recycling centers for aerosol containers  are
       not available in many areas.  The alternate statements are in addition to the
       disposal instructions.

       Review sections A and B below to determine the appropriate document to use as
       the source of the container disposal statements.
Storage and Disposal
                     Page 13-7

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Label Review Manual
                                     Current as of December 27,1996
       A.
        B.
Hpmeowner Products: If the label under review involves a chemical for
wMch a recent Registration Standard or RED was issued (after 2/12/86, 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: LP-86-02) OR
            .  .       ...      -                                   -
(2) "Do aot reuse empty container (bottle, can, bucket). Wrap (container)
and put in trash." (Reference PR-84-01) OR
\ i '   ' •  '"'"'• '"'• :"  : '••    .     ' '      I    " I'' '.                        '
(3) One of the statements from PR Notice 83-3, particularly the one for non-
aerosol, non-bag containers: "Do not reuse container (bottle, can, jars).
Rinse thoroughly before discarding hi trash." (Reference: PR-83-03) OR
(4) For aerosol containers,  'This container may be recycled hi aerosol
recycling centers. At present, there are only a few such centers m the country.
Before offering for recycling, empty the can by using the product according
to the label (DO NOT PUNCTURE!).  If the recycling is not available, wrap
the container in several layers of newspaper and discard hi the trash."
(Reference: PR-94-02)

Note: The first allowable statement is identical to the statement required for
the disposal of household/domestic use pesticides.  In other words, the same
statement could serve as disposal instructions for the pesticide and the
container.     _    '•  'j   '...•'..-..'". ..... : ..... ,.', ........ .,  -..'I ..... ''.'•  ',  II ..... Ill

All Other Products: If the label under review involves a chemical for which a
Registration Standard or RED was issued after PR Notice 83-3 (issued
 3/29/83), 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, refer to Table 2 below which
 provides the container disposal statements  from PR Notice 83-3.
 Storage and Disposal
                                                             Page 13-8

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Label Review Manual
Current as of December 27,1996
                                     Table 2
Container Type
Metal Containers (non-
aerosol)
Paper and Plastic Bags
Glass Containers
Fiber Drums with Liners
Plastic Containers
Compressed Gas Cylinders
Disposal Statements
Triple rinse (or equivalent). Then offer for recycling or
reconditioning, or puncture and dispose of in a sanitary landfill, or
by other procedures approved by state and local authorities.
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.
Triple rinse (or equivalent). Then dispose of in a sanitary landfill or
by other approved State and local procedures.
Completely empty liner by shaking and tapping sides and bottom to
loosen clinging particles. Empty residue into application
equipment. Then dispose of liner in a sanitary landfill or by
incineration if allowed by State and local authorities. If drum is
contaminated and cannot be reused, dispose of in the same manner.
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.
Return empty cylinder for reuse (or similar wording).
       C.    Specific Container Disposal Language: (Reference: LP96-08); see that memo
             for additional information on Resource Conservation and Recovery Act
             (RCRA) regulations concerning disposal of bags, or empty liners.

                   FuradanSG

                         "Completely empty bag into application equipment by shaking
                         and tzipping 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, bag is an acute hazardous waste and must be
                         disposed in accordance with local, state and federal
                         regulations."
Storage and Disposal
                      Page 13-9

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Label Review Manual
Current as of December 27,1906
                   Furadan4F
                          "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."
 Storage and Disposal
                       Page 13-10

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Label Review Manual
                             Current as of December 27,1996
Chapter 14
GRAPHICS & SYMBOLS ON LABELS
Introduction

      Graphics and symbols are often found on pesticide labels, but may or may not appear
on the draft labeling under review.  They may appear for various reasons especially in
association with the Directions for Use section, or as a marketing tool. Graphics and symbols
are acceptable and their use should foe encouraged on product labels in addition to written text
as long as they afford greater comprehension of the label language, do not obscure or crowd
required label language, or misbrand the product.  Symbols may not be used instead of
required text. Refer to the information below for guidance in determining whether graphics
and symbols the reviewer may see  during the  label review  process are acceptable or
unacceptable. Consultation with the PM/team leader and/or Branch Chief may be necessary
if a close judgment call is involved. (Reference: FEDERAL REGISTER (FR) Proposed
Rule on Labeling Requirements, Vol. 49, No. 188, ง, 156.10(e) (9/26/84)(MLD-l 1))

Acceptable Graphics & Symbols                       '               '

      Graphics and symbols are encouraged on product labels if they serve to enhance the
understanding of the accompanying  text  Examples of acceptable graphics and symbols
include:

      ซ•    Use information presented in tabular form.

      ป    Arrow diagrams of how to open product containers;

      ป    Graphics which display spray patterns of nozzles and/or application patterns
            and are supported by the label text.

      w    Skull and Crossbones next to the word DANGER on products classified as
            Toxicity Category 1 based on acute oral, acute dermal and/or acute inhalation
            toxicity data.

      **    Pictograms near the precautionary labeling statements depicting the different
            exposure routes (oral, inhalation, and/or dermal) to pesticides.

      ซ•    Pictures showing examples of places where the pesticide may be used, such as in
            a household or a specific commercial site which are supported by the label text.
Graphics & Symbols on Labels
                                                   Page 14-1

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Label Review Manual
Current as of December 27,1996
             Quid hazard drowning pictogram and labeling (a picture inside a circle with a
             line through it showing a bucket with a child turned upside down in the bucket).
             This  is a voluntary standard label developed by the Coalition for Container
             Safety, 1-800-203-9200.  Such pictograms may be seen on the labels for large
             buckets.   This  pictogram may not obscure or detract  from the Federal
             Insecticide, Fungicide, and  RodentieideAct (FIFRA) required text.  If the
             pictogram is accompanied by the word "WARNING", this pictogram should not
             appear on the front panel or near the precautionary statements as it may be
             confused with the pesticide product signal word.
               .1!  : '        	' .   : • " '•.  .,-  i •      ,   III                              I'  IN
             Mr. Yuk symbol on the label and or outer container of product. Mr. Yuk is
             pictured as a green frowning face with his tongue hanging out. This symbol
             ,c ' , :,,i .1, "„ : '.i'1 •"' •!•"! •""' • •.         i
             Pictures depicting appropriate protective gear.
             Pictures illustrating proper use.

             Kosher Symbols (Reference: LP95-02).

             HMIS/NPCA and NFPArating systems for hazard codes (Reference: LP95-36).

             Use of a circular logo [similar to the "ghostbuster" circle but with a horizontal
             slash through the center] indicating absence of chlorofluorocarbons (CFCs) as
             long as:
             1) the exact wording from PR Notice 92-2 (Reference: PR-92-02) is used in and
             immediately next to the logo, and
                                          1  i1   • ,i'  ni  •" . " , "'u, i in	 	 , 'i • 'i',  ', , •  i, ' ,  ",  • ', '      i      i  i          i              ,
             Such a logo and statements may be added by notification (see PR Notice 95-2
             for the procedure). (Reference: LP96-09). Logos may include smaller text
             lettered around the inside of the logo itself as long as it doesn't claim anything
             m|>re than what's in the 92-2 text, and it doesn't'say so little as to be misleading.
             (Reference: Message Log #6, 5/21/96)
 Graphics & Symbols on Labels
                       Page 14-2

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 Label Review Manual
Current as of December 27,1996
 Unacceptable Graphics & Symbols

       If the draft label under review contains any of the following graphics/symbols, inform
 the registrant that they must be removed from the label.            .

 1.     Graphics and Symbols which are unrelated to the use pattern on the draft label. Some
       examples are listed below:

       •*•    A food pictured on a label which bears no directions for use on that food. A
             .picture of cherries may not appear on a label if the product is not registered for
           -  use on cherries.

       ซ•    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 resistent coveralls with goggles, the label
             illustration cannot show a person wearing shorts and no protective eyewear.

       •*    Pictures of a pest not claimed to be controlled by the product.

       w    Pictures depicting any nonfood site not claimed on the label.
           '     -         *               ..'..'.•     '      ..
 2.     Graphics and symbols which are misleading to the user. Some examples are:

       •*•    Pictures of children playing, unless the product is registered for use on children.

      ••*    Pictures of candy.

       ซ•    Symbols implying safety or nontoxicity, such as a red cross or a medical seal of
             approval.

       ซ•    Pictures of flowers or fruit (e.g., a lemon slice, Reference: Message Log #3,
             4/5/95 (MLD-20)) on a label wmch imply that the product has a floral or fruity
             fragrance and the formula does not contain such ingredients.

       w    Pictures of  use sites in a residence when the product label is limited to use in
             commercial or industrial sites.
Graphics & Symbols on Labels
                     Page 14-3

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Label Review Manual
Current as of December 27,1996
      w    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" (Reference: LP95-01).

      ซ•    Graphic symbol which  contains  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 ^^w^
            component or to the entire product (Reference: LP95-04).

Graphics & Symbols Not Subject'to FIFRA Which are Acceptable

      The following graphics and symbols are not required under FIFRA and are not part of
the label review.
            Department of Transportation symbols indicating the hazard and flammability
            of a particular chemical or pesticide.
            Barcodes which allow for easier scanning of prices in retail stores.  (Reference:
            LP92-03)
Graphics & Symbols on Labels
                      Page 14-4

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Label Review Manual
                            Current as of December 27,1996
Chapter 15
COMPANY NAME AND ADDRESS
Introduction

      The company name and address of the registrant are required features of the
pesticide product label.  These features must be displayed prominently and within the range
of type size that is required for all label text (see chapter 3). These may be found any where
on the label, but are most commonly found on the front panel of the pesticide label (see
156.10 (c)).

Foreign Registrants                                          .               '.  ,    '

      If the registrant is not a resident of the United States, he must designate an agent
who resides in the United States and to whom all correspondence concerning the product or
any subsequent registration actions wilf go [see 40 Code of Federal Regulations (CFR)
152.50 which outlines the requirements of a foreign registrant]. However, such registrant's
label should always reflect the name and address of the foreign registrant.

Name of Record            .        ,

      If a company is a division or subsidiary of another, but that company's name is not
the name of record, the company cannot add the statement "a division (or subsidiary) of
	" under the manufacturer's name on the label. Although the company is a division or
subsidiary of another this is not the name of record and they will need to make the name
change if they want this language on the label (Reference: MLD-17 and MLD-20).

Co-name Changes        '

      Registrants are required to keep the Agency current as to the correct name and
address of record. If a company changes name, they do not have to submit an amendment
to add the new name on the label, however the registrant must inform the Agency by letter
of the name change. A separate letter must be sent to the Document Processing Desk
(Distribution  Code COADR), Office of Pesticide Programs, 7504C, U.S. Environmental
Protection Agency, 401  M Street, SW, Washington, DC. 20460-0001 informing us of the
change. The registrant may start using the new name as soon as it occurs, or they can use
the same label (old name) until the  next printing or for 18 months, whichever comes first.
(Reference: Message Log #5, 9/12/95). ,         •  ,.
Company Name and Address
                                                  Page 15-1

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 Label Review Manual
                              Current as of December 27,1996
 Chapter 16
CONTENTS/NET WEIGHT STATEMENT
 introduction                                                  ,

       The Net Contents statement identifies how much pesticide is in the container. Usually
 draft labels will only 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 actual
 amount of pesticide is usually left blank because the registrant often intends to market the
 product in various sizes.  The reviewer can refer to the Application for Pesticide Registration
 form (EPA Form 8570-1) for information on the various container net weights. Actually, the
 regulation,  (40  Code of Federal Regulations  (CFR)  156.10(d)) does not require the
 term/heading "Net Weight" or "Net Contents" to be stated on the label, although it does require
 that the weight/volume be expressed as the net weight/contents. Even so, the Agency strongly
 recommends that the term "Net Weight" or "Net  Contents" be reflected on the label, since it
 describes the amount  of material in the container as opposed to the weight of the entire
 product.  This could reduce the possibility of confusion and/or.questions by users.

 Location of Contents/Net Weight Statement      •  .  ,

       There is no required location  for the 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 contains the contents/net weight statement in some other location, the
 reviewer should suggest that the statement be placed on the lower third of the front panel.

 Type of Measurement

       Check the draft label to determine if the contents/net weight statement is expressed
 correctly.  [40 CFR 156.10(d)]

 1.     DRY FORMULATIONS (includes solids or semisolids such as dusts, granulars,
       pelleted or tableted baits, wettable powders, microehcapsulated product, impregnated
       materials): The net weight shall be expressed as pounds or ounces.

2.     LIQUID FORMULATIONS: The net contents shall be expressed as gallons, quarts,
       pints  or fluid ounces:

3.     PRESSURIZED PRODUCTS (includes gases and aerosols): The net contents shall be
       expressed  as avoirdupois pounds and ounces.
Contents/Net Weight Statement
                                                   Page 16-1

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Label Review Manual
Current as of December 27,1996
Expression of the Statement
             "''          ' „  i       ' '    ',        i        ^
      Review the draft label to make sure that it meets the following requirements:

1. "   UNITS OF MEASURE: Conventional "American" (U.S.) units of measurement are
      used,  It is permissible, but not required, for labeling to declare net contents in metric
      units (liters, kilograms, etc.), so long as U.S. units of measurement are also declared.
      For example, "Net Contents:  1 gallon (3.785 liters)." It is not acceptable to Hst
      ONLY metric units.  The same policy holds for'the 'ibrrectionsTorUise. For example,
      the applicant may elect to use the equivalent kilograms per hectare in addition to
      expressing application rates as pounds per acre.
      EXPRESSION OF NET CONTENTS: The Net Contents must be stated in terms of
      the largest suitable units. For example, "1 pound Qb.) 10 ounces" would be shown on
      the draft label instead of "26 ounces."
         	'""       „     . .        ', ,  i                                *   .",,'',, V i'^ ,'!.•• "l|l||il	,'

      CONSISTENCY WITH DIRECTIONS FOR USE: The Directions for Use on the
      label must not call for more than the net contents of the package. An extreme example
      is a granular product may not have labeling stating: "Net Contents: 1 pound" and then
      have an application rate in the directions for use of 200 Ibs/acre. This problem often
      occurs with baits used to control rodents.
Contents/Net Weight Statement
                     Page 16-2

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Labef Review Manual
                        Current as of December 27,1996
Chapter 17
IDENTIFICATION NUMBERS
Introduction     .                                           .

      The EPA Registration Number and the Establishment Number are required on all
pesticide labels and labeling. This section also covers Distributor Registration Numbers,
Special Local Need Registration Numbers, and Experimental Use Permit Registration
Numbers.

EPA Registration Number

1.    ASSIGNMENT OF REGISTRATION NUMBER: Before a pesticide product is
      registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
      Section 3, the reviewer may see an EPA File Symbol composed of a company number
      followed by a series of letters representing the future product number. Product numbers
      are assigned sequentially. The letters are used instead of the numbers to preclude people
      from thinking that the product is already 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,O-9, and N=
      0.  Therefore, if 6767-EGN is 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.

2.    PURPOSE OF REGISTRATION NUMBER:  The EPA Registration Number
      indicates which company holds the registration for the pesticide, and in which sequence
      the product was registered by the company.  For example, the first  product for a
      particular company will be product number one, and the second will be two, and so on.
       The reviewer  will see  the registration number preceded .by the phrase, "EPA
      Registration No., or EPA Reg. No." This will be followed by a company number then
      a dash (-) then the product number.                     .    .'.-'.

      This phrase and number has no location requirement but is often found on the front
      panel of the product label.  (40 Code of Federal Regulations (CFR) 156.10 (e)).

3.    DISTRIBUTOR NUMBERS: FIFRA and  the regulations permit a registrant  to
      distribute or sell a registered product under a distributor's name and address (40 CFR
      152.132). ThisiscaUed "supplemental distribution." Although distributor labels are not
      submitted to  EPA for review and stamped approval, questions that concern them may
Identification Numbers
                                             Page 17-1

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Label Review Manual
Current as of December 27,1996
                                             ,",! ",' '!	 V !',, Jis," ,!'!,, • „&, I".
                                                                             i1",,,I!'" VJ1ซ 	If "Hi ii #i,i	I!;1 "ill,I
      arise from internal or external customers. The distributor label must be the same as the
      registered product (basic registration) except for: product name, name and address of
      distributor, and any claims (uses, for example) that are deleted from the label. Subject
      to the enumerated exceptions, 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 generally permit,
      however, minorfonnatting 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 (subject to the exceptions listed
      above) to that of the basic product.(Reference: LP96-01) The company's name can not
      be abbreviated on a distributor label unless it is complete enough to enable a reader to
      identify the company from a phone book so that he/she may contact the manufacturer
      (Reference: MLD-17). Multiple company names are not 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 (jjstrikutops gp^ company number and
      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. (Reference: LP94-23) Thelabel must show the EPA Est. No.of the
      final establishment at which the product was produced.

      Both a registrant's name and a distributor's name can appear on the label, but it has to
      be VERY clear who's doing what; Le., manufactured by  ....; distributed by...  or
      distributed  for...   (Reference: Message Log #6, 4/12/96).   When  the phrases
      "manufactured by",  or  "produced for" are  used on a label  they may  only be
      accompanied by, or refer to, the registrant's name, (ref guidance given to NY State by
      Jim Downing on 7/24/96)

      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, Rhdne-Poulenc has a registered product, FOLEX 6EC  Herbicide, EPA
      Registration No. 264-498.  By notification to the Registration Support Branch of the
      Registration  Division,  Rhdne-Poulenc adds  Cornbelt Chemical  Company as  a
      distributor. Cornbelt's assigned company number is 10107. The FOLEX ECmarketed
      by Cornbeit (under their product name) must bear EPA Registration No.  264-498-
     ' 10107. An EPA Registration Number consisting of three sets of numbers partitioned
      by dashes can be identified as a distributor product. Distributors may not amend their
      product labels. Only the basic registrant (in this example, Rhdne-Poulenc) can amend
      registered labels.
Identification Numbers
                      Page 17-2
                                                                             ;:,,„, ':,:;#;!';,"
                                                l!  •  : iiir1', , M"" '*

                                                iii,"  ''i ! i "!!'!":	• ' !'''',': I,;,!

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 Label Review Manual
Current as of December 27,1996
 EPA Establishment Number                                   .

       The establishment number is not reviewed or assigned by PM teams. It is assigned by
 EPA Regional Offices and the Office of Enforcement and Compliance Assurance (OECA).
 The PM's only responsibility is to ensure that it is formatted correctly.

 1.     PURPOSEOFESTABLISHNffiNTNUMBER:IlieEstablisJmientNumbermdicates
       where the final phase of production of the pesticide product took place. This number
       is preceded by the phrase, "EPA Est. No.," and may appear anywhere on the pesticide
       product label, or on the outer container or packaging of the product (40 CFR
       156.10(f)).  It often is grouped together with the EPA Registration Number, but is not
       required to be. (40 CFR 167.3).

 2.     LOCATION OFESTABLISHMENT NUMBER: The establishment number must
       appear on the product label, or on the immediate container of the product. If the EPA
       Establishment  number cannot be seen  or clearly read through the wrapping or
       packaging of the pesticide container, it must also appear on the outside container or
       wrapper of the product{40 CFR 156.10(f)). Since 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.

 3.     STATE DESIGNATION:  Letters such as  MO, AZ, or PA,  appear after  the
       establishment number, and these letters represent the state that the product was
       produced in. For example, you may see an establishment number written as EPA Est.
       No. Company No.-MO-l, which would indicate that the establishment number is the
       first establishment registered in Missouri..

       ซ*•    For  example: If the company, is Cornbelt Chemical Company, and their
            company number is 10107,and the last phase of pesticide production took place
            at producing establishment number 89 in Hawaii, then the Establishment
            number for this product would read 10107-HI-89.

4.    MULTIPLE ESTABLISHMENT NUMBERS: Agency policy permits the use of
      multiple establishment numbers onproducts provided that the registrants meet existing
      labeling  regulations  (40 CFR  156.10(f)) and follow the format for multiple
      establishment numbers. However, if a producer uses multiples establishment numbers,
      it must be very clear which establishment number is the actual production site.
Identification Numbers
                    Page 17-3

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Label Review Manual
                                                 Current as of December 27,1996
Special Local Need fSLN> Registration Number

      The Special Local Need registration number (SLN number) is also known as a FIFRA
Section 24(c) Registration Number. These federal registrations are issued by the states to meet
special local needs. (40 CFR 162) The number is written as "EPA SLN No." followed by the
last two digits of the year of issuance, then a four digit number which is the consecutive number
of registrations that the registering state has issued in that particular year.
                                                                               n1	SJSKIJ*'.	-il'si
•r    For example: If the company,
      of North Carolina, and is the 34th consecutive state registration in North Carolinain
      the year 1995, then the 24(c) registration number would be EPA SLNNb. NC950034.
      Although  most  24(c)  registrations  amend federally registered  products with
supplemental labels, thestate mayalsoregisteranew end-use product (not federally registered)
as a 24(c) registration. The ingredients (including inerts) of the new end-use product must be
contained  in one or more federally registered (section 3) products. (CFR 162.152(b)(2)).

      The EPA 24(c) registration number is assigned by the state and entered on the state
registration application form (different from section 3, Application for Pesticide Registration
form, EPA Form 8570-1). In addition, if the 24(c) registration is an amendment to a federal
section 3 registration, the EPAregistration number of the federal product is also entered on the
application form.

Byperjmental "Use Permit Number

      Experimental Use Permits (EUPs) are issued by the Agency under Section 5 of FIFRA
to anyone  who wants to develop data on either a new product or a new use siteTor a future
FBFRA Section 3 registration. EUP applicatipns 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 approved by the Agency and/or an associated temporary
tolerance has been established.  Refer back to part 1 .A. for information on the translation of
file symbols to registration numbers. (See 40 CFR 172.6)
          ;'    	  .      ซ, • n, '  '"    ',,',,,'„              i     HI -
ซr    For example: FMC, whose company  number is 279, applies for an EUP to
      collect data on the crop kale and no tolerance is yet established for kale. It is
      given the file symbol RLE until the EUP has been approved" 'ancTthe temporary
      tolerance has been established, if applicable.  Once this EUP application  is
      approved, the file symbol 279-EUP-RLE will become EUP Number, 279-EUP-
      152, since this is the 152nd permit for which this company has applied.
Identification Numbers
                                                                      Page 17-4

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 Label Review Manual
                          Current as of December 27,1996
 Chapter 18
UNIQUE PRODUCT LABELING
 Introduction   .

        Certain specialty products pose a challenge  for meeting the regulatory labeling
 requirements. Package size, shape, and composition often dictate unorthodox approaches to
 attaching the necessary information.  The following examples have been accepted by
 Registration Division (RD), oftenafterintensediscussionwiththeregistrants, andmaybeused
 as models for new and novel products that will undoubtedly be developed hi the future.
 REMEMBER - one rule always applies:  the required front panel statements (ingredient
 statement,  signal  word, skull and crossbones (if required), child hazard warning, EPA
'' Registration No.,  RESTRICTED USE PESTICIDE, (if so classified) and a reference to the
 location of other precautions) must always be visible on the outer container label sold as a retail
 unit.   .    .•; '.     -    .••     ".',     •      .    "            -'••''   "''  :  •  ." .. ~'

 Multi-Packs/Co-packs                                           .          .

        This category has two situations which are as follows:

 1.     PESTICIDES PACKAGED WITH A NON-PESTICIDE: This situation includes a
        pesticide product which is packaged with a non-pesticide component such as an
        adjuvant in a separate container (which is to be added to the pesticide during mixing)
        sold together hi two separate containers in a single retail unit;

        According to the definitions set forth in 40 CFR part 152.3, the products are distributed
        and  sold  as a  single retail  unit  and together comprise the pesticide  product.
        Accordingly, the Agency has jurisdiction to review the labeling of the pesticide product
        as well as the non-pesticide component. If the components are attached together, such
        with a shrink-wrap sleeve or in a box, the front panel of the pesticide must be visible.
        If it isn't,  the front  panel must be duplicated and attached  to or printed on the
        outermost  container.

 2.     TWO OR MORE PESTICIDES PACKAGED TOGETHER: This situation includes
        two or more pesticide products packaged in separate containers but sold together as a
        single retail unit and intended to be used as tank mixes just before application.

        Each container must bear or be accompanied by full labeling and the front panel must
        be visible under conditions of purchase. As above, if the outermost packaging obscures
  Unique Product Labeling
                                                Page 18-1

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Label Review Manual
Current as of December 27,1996
      the front panels of the pesticides, the front panels must be duplicated and attached to
      the outermost container.

      Policies regarding the labeling formulti-packs and co-packs arecurrently being clarified
      by the Agency. Please contact the Labeling Unit for additional information before
      submitting registrations or amendments that feature multi-packs and co-packs.
         '  •  '::	.• .• '   !  '•'.   '.::,:                 |     ij   'ill              >      111  |!'i
      40 Code of Federal Regulations (CFR) 152.3(t) states that the "pesticide product"
      includes  the entire package as the product is Intended to be distributed or sold.
      Therefore, we have full jurisdiction regarding the labeling of any "non-pesticide" which
      is part of the package. "Jurisdiction" means that the Agency has the right to review and
      approve any aspect of the container or labeling of the non-pesticide product if it is
      packaged with a pesticide.  The reviewerexamines' the""n6h-jpesticide labeling to
      determine whether it contains any language that conflicts with the pesticide label, but
      does not actually stamp the non-pesticide label.  An example would be a label for an
      activator (such as potassium permanganate) which accompanies a pesticide (sodium
      bromide)!  EPA reviews the labels for both products, but stamps only the registered
      pesticide label, noting any problems or changes we recommend for the non-pesticide
      label (Reference: MLD-20).

Small Containers
*"•••*•a^M^^kwnMMlMMb                       ,           .        i
                 i   , "     •     ,, "    ..   '"" : .' •    .". ' ihi
      Certain containers are too small to bear all required labeling.  In those cases, it is
permissible to have all text except the  required front'"panel information  located  on
accompanying pamphlets which are considered labeling. The following information shall be
the minimum requirement for the label of small containers: statement of active ingredients),
signal word, skull and crossbones (if required), child  hazard warning, EPA Registration
Number, thephrase "RESTRICTED USEPESTICIDE"ifclassified, andareference statement
to any accompanying pamphlets. Outer boxes,  bubble-packs, accordion-pleated  attached
labels, and plastic self-sealing envelopes containing additional labeling have been accepted.
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 contain a statement directing
the user to the location of any additional labeling which is securely affixed to the container.
All of this labeling must be reviewed and found to be acceptable.
Soluble Packets
      An increasingly popular means of packaging is the water-soluble packet. It is also an
Agency-mandated approach to reducing exposure of mixer-loaders to dust, vapor, or liquid
Unique Product Labeling
                      Page 18-2

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Label Review Manual
Current as of December 27,1996
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 technique  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. Themost widely used is another tear-open foil
envelopeconteiningeachsolublepacket;thefoilbearstherequiredlabeling. 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 such depression.  The
tear-off top bears the required labeling.  The vital consideration in dealing with soluble packets
is reducing the likelihood of the consumer removing unlabeled packets from labeled containers
long before use and then forgetting what they are. Since laundry detergents and dry bleaches
are also manufactured in soluble packets, the risk of a serious case of mistaken identity must
be avoided. It is NOT permissible to simply package a quantity of unlabeled soluble packets
in an outer container where they could be easily separated from the accompanying labeling.
EACH packet must either bear identifying labeling on the film itself (where feasible) or on
packaging immediately enclosing that packet. PR Notice 94-8 (Reference: PR-94-08) describes
the registration requirements for pesticide products containing water soluble packaging (See
chapter 8 for reduced Personal Protective Equipment  for Water Soluble Packaging products
subject to the Worker Protection Standard.

Bulk Containers                          .

      Agricultural pesticides are often sold by dealers out of bulk tanks directly into sprayrigs
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.  When
reviewers receive such submissions, it  should include the label which appears on the tank
container which contains all the front panel information and a separate full label for review.

Non-FIFRA Labeling Text

      Some labels submitted  to the Agency have a panel devoted  to Department of
Transportation  (DOT) shipping rules, or have New  York City fire code symbols, HMIS,
NPCA and NFPA (hazard codes) rating systems, bar codes, or PA Dept. of Ag. numbers.
Such text is permissible unless it obscures or crowds the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) required text.
Unique Product Labeling
                      Page 18-3

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 Label Review Manual
Current as of December 27,1996
 Foreign Language Labeling

       Foreign language text, in addition to the full English text, is permitted in its entirety on
 the product label so long as the applicant certifies that it is an accurate translation of tie
 English.  It is NOT the responsibility of the Office of Pesticide Programs (OPP) to attempt the
 review of such text. If the foreign text is inaccurate or goes, beyond the reviewed and accepted
 English labeling, the certification on record is the evidence that will be used by the Office of
 Enforcement and Compliance Assurance can take the appropriate enforcement action under
 40 CFR i56.10Xa)(3).
                                                                  ?

 ]Dual Labeling on One Container                      •     ,

       Use of two labels, an EPA approved label and an international label, on one container,
 has been allowed only for manufacturing use products, when the following requirements were
'met:     	           	'   "	"•"•	'	,	."	:	"",	:'	," '  '•	"'."	,

       •r    Themtemationallabelisdeemedpermissibleadditior^
             to 40 CFR 152.46. The EPA approved FIFRA section 3 label text will not be
             modified and is to remain consistent with 40 CFR 156.10.

       ซr    Each label, the International and  the EPA approved, will be printed on the
             product container and will  occupy one panel apiece.  Placement of the EPA
             approved panel is in accordance with 40 CFR 156.10.

       •*    Each panel must be appropriately identified as such: "International Panel" and
             U.S. Panel."	•'. '	"'""''	'	'"'	"	'	"'	."	' '	""T	
             The International panel must have the following referral statement in all
             languages that  are on ~ the  panel that instructs the pesticide user to the
             appropriate  section on  the label:  "DO NOT refer  to this panel when
             formulation, use, storage or disposal occurs in the U.S."

             No statements which appear on the international panel label will add new uses
             or claims or in any way contradict the EPA approved FIFRA section 3 labeling.
             The registrant must submit a signed certification statement verifying this when
             submitting the international panel labeling.
             Exported products must comply with 40 CFR 168.65, which addresses labeling
             requirements not addressed above. The requirements at 40 CFR 168.65 apply
Unique Product Labeling
                      Page 18-4

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Label Review Manual
Current as of December 27,1996
             whether a pesticide product is produced in the UnitedStates or imported into the
             United States and intended for re-exportation.  (Reference: LP94-30)
Pesticides Used to Treat Seeds

      The Federal Seed Act, administered by USDA, requires pesticide-treated food crop
seeds to be discolored before they may be sold in interstate commerce. It is OPP policy to
require pesticides bearing directions for commercial seed treatment (as opposed to drill-box,
planter-box, and slurry treatments done by the farmer immediately before planting) to have
either a dye in the formulation OR bear labeling warnings in the directions informing the user
that treated seeds must be discolored before being  sold.   The labeling option is  the
overwhelming choice of registrants since a product intended to treat a broad spectrum of crop
seeds cannot have any one dye that will discolor every seed. Seeds come in many colors. For
example, red dye would not discolor kidney beans, black dye would not discolor cotton seed,
and yellow dye may not show up on corn.

Child-Attracting Packaging ("Attractive Nuisance")

      From time to time, registrants attempt to package pesticides in containers attractive to
the consumer and the consumer's children. Bait-type pesticides for rodents and roaches are a
favorite type of product that have been marketed in little doll houses, fire trucks, and other
toy^like dispensers or containers that look like food containers, e.g. milk carton shape. These
types of packages are not acceptable.  They add nothing to the efficacy of the pesticide and
increase the hazard to  small children. It is recognized that it may be difficult for the reviewer
to determine the package style when the final printed label is only a printer's proof and  not
usually given afinal review. However, certain types of products amenable to such unacceptable
packaging should be checked and if any  doubt or suspicion arises, the applicant may be
contacted.

      Rodenticide place packs often appear in brightly .colored labels which can resemble
certain candy wrappers. Labels for these products require that they not be used and stored in
locations accessible to children under six years of age. Due to the dose convenience that  this
type of borderline child-attractive packaging offers to product users, EPA accepts it as long as
the appropriate precautions and  use restrictions appear on the label.

Secondary Containers

       There are cases where users of concentrated products dilute and then use/store the
product in a separate unmarked container (secondary container). Although the Agency does
 Unique Product Labeling
                       Page 18-5

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Label Review Manual
                                                  Current as of December 27,1996
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 if 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.-

3.


4.



5.
      EPA registration number;
      •Name and percentage of active ingredient, followed by the phrase "The product in this
      container is diluted as directed on the pesticide product label."
      Signal word and precautionary statements from the registered label unless the registrant
      has acute tqxicity data supporting a lesser signal word and precautionary statements;
      and
      Thestatement: "Followthe directionsfor-useon thepesticide>label'when applyingthis
      product."                           ''.                                        ,
      "Not inconsistent" would mean 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, the above is considered guidance only. Registrants are not required to submit
these secondary labels for review by the agency, however if the secondary label is inconsistent
with the EPAapproved label, the Agency will consider the product misbranded. Thisguidance
is not intended to apply to hand-held containers used by structural pest control operators who
are regulated.
                                                 .. I1 ; • ',, ''  'Mi ,"
 Unique Product Labeling
                                                                          Page 18-6

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