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Label Review Manual
Chapter 11: Directions for Use

Table of Contents
Chapters:
  1. Purpose of Manual
  2. What is a Pesticide?
  3. General Labeling Requirements
  4. Types of Label Reviews
  5. Ingredient Statement
  6. Use Classification
  7. Precautionary Labeling
  8. Environmental Hazards
  9. Physical or Chemical Hazards
  10. Worker Protection Labeling
  11. Directions for Use
  12. Labeling Claims
  13. Storage and Disposal
  14. Identification Numbers
  15. Company Name and Address
  16. Graphic & Symbols on Labels
  17. Content/Net Weight Statement
  18. Unique Product Labeling
  19. The Consumer Labeling Initiative and Pesticide Labels


On this page

  • I. Introduction
  • II. Review Strategy for Directions for Use
  • III. Content
  • IV. Standard Requirements
  • V. Application Information
  • VI. Guidance for Wording Application Information
  • VII. Additional Application Information
  • VIII. Storage and Disposal Instructions

    • I. Introduction

    1. This chapter outlines the basic elements of the Directions for Use portion of the label and provides a review strategy for ensuring that this information is presented in a clear, concise and effective manner. Label writers and reviewers should keep in mind the distinction between mandatory statements and advisory/recommended information, and try to write the label statements accordingly. See PR Notice 2000-5

    2. Purpose of Directions for Use. The "Directions for Use" section of a pesticide label describes how the product may legally be used and how the product must not be used. The requirements for the directions for use section are found in the regulations at 40 CFR 156.10(i), but generally speaking the information necessary is as follows:

      • the pest(s) that the product may be used to control;
      • the sites where the product may be used;
      • the application methods that are required or preferred;
      • how much pesticide should be applied and the rate of application;
      • whether there are any restrictions on use for factors such as weather, time of day, season of the year, contamination of sensitive areas, exposure of nontarget species, etc.;
      • the application methods that are prohibited;
      • how often the pesticide should or may be applied;
      • all restricted entry intervals (REIs) pertaining to existing uses, as applicable;
      • maximum application rates (per treatment and per year);
      • preharvest intervals (PHIs); and
      • any other requirements as necessary

      The directions for use reflect the Agency’s determination that the use of the product in such a manner does not cause unreasonable adverse effects on the environment under FIFRA. The Directions for Use section should be organized and carefully worded so that the directions are understood by the person expected to use or to supervise the use of the pesticide. Sentences should be written to indicate whether any actions mentioned are required, prohibited, encouraged, or discouraged. Other sentences in the use directions may be used only to convey background information.

    3. Format. Charts, tables, and graphics may be used in the Directions for Use section as long as they do not contain or imply false or misleading information and they provide accurate information in a clear, concise and complete manner. Instructions may be numbered if a true sequence of actions is required.

    4. Clarity. The text in the Directions for Use section should be expressed in complete sentences. These sentences should be direct and to-the-point, while covering all necessary information. Directions should be expressed as clearly and concisely as possible. Long and /or complicated paragraphs of narrative instructions should be avoided wherever possible. The label reviewer should direct registrants to alter any text which appears to be incorrect, confusing, or contradictory to other label statements. If the reviewer knows what the registrant intends to write (or what EPA permits to be written) on a particular matter, the reviewer can draft corrected text. IF the reviewer cannot determine the registrant’s intent, the reviewer should identify the area of concern for the registrant, explain the problem with the information, and inform the registrant that revised text is needed to meet FIFRA standards.

    5. Examples. Consider the following statement taken from the Directions for Use section of a pesticide product’s label:
      "Mix 1½ to 2 pints of (pesticide) in 100 gals. of water. Apply 100 to 200 gals. per acre depending on spray equipment and tree size."

      It is not clear to what the language "Apply 100 to 200 gals per acre..." refers. Does it refer to undiluted product, or does it refer to the diluted spray solution? Is the applicator to simply add more water to a 100-gallon spray mix to cover larger trees or to use twice as much of spray solution mixed as directed by the first sentence?

      Assuming that the “100 to 200 gals.” refers to diluted spray mix, improved instructions would be:

      To make spray solution, mix 1½ to 2 pints of this product in 100 gals. of water. Apply 100 to 200 gals. of diluted spray solution per acre to trees depending on tree size and the coverage obtained with the spray equipment used.

    6. Application Rate. The actual application rate, ( e.g., how much product to apply per unit area or per placement) must be stated in the Directions for Use. Labels for agricultural products usually express the application rate in terms of pints/acre for liquid formulations, or pounds/acre for solid formulation. The Directions for Use for an agricultural pesticide used in a spray solution also must indicate the spray volume/unit area or other measurement of coverage, depending on the type of formulation.

      Labels for residential/household use products should express the application rate in smaller, units, such as ounces, teaspoons/gallon, or pounds/square foot. Such rates and units of measure are more appropriate for the home garden or yard. Any pesticide application equipment required by a residential user should be readily available, like simple equipment such as drop-spreaders or hose-end sprayers. The public generally does not have access to (and does not use) specialized equipment. When percentages are included in application rates, it should be clear whether percentages are by weight or volume and whether the percentage refers to the product or active ingredient. Percentage application rates should never be used alone. The specific amount of product to use per unit area should always be clearly stated in the Directions for Use.

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    II. Review Strategy for Directions for Use

    1. This section presents recommended strategies for reviewing the Directions For Use section of pesticide labels. It also presents two different methods for reviewing the label and provides a list of key questions that reviewers must ask as they review the label. It also discusses some common problems and issues that reviewers face when reviewing the Directions For Use section.

      Some draft labels may contain statements or information not acceptable according to FIFRA, or the implementing regulations. Such statements must be corrected. In addition, various policy documents including Pesticide Registration Notices provide guidance on particular issues. Label reviewers should use the guidance along with the applicable laws to make case-by-case determinations on the acceptability of label language.

    2. Type of Label Reviews for Directions for Use

      1. Me-too Application. If the application is a me-too submission (see chapter 4), reviewing the directions for use is fairly straightforward: The label reviewer should make a side-by-side comparison of the proposed set of use directions to the use directions on the label for the registered product(s) which are identified in the me-too application.

        Target pests or use sites found on the registered product’s label may be omitted from the me-too product’s labeling. For example, a me-too application is made for an insecticide formulation to add structural perimeter treatments for crickets, ants, and sowbugs. The registered product referenced in the me-too application must be labeled for this site, and its label must claim crickets, ants, and sowbugs; although other species (earwigs, millipedes) also may be claimed on the registered label. While the pending submission need not have all the pests listed on the registered label, no new use sites or pests or new public health pests may appear on the label for the pending me-too product. The format for the presentation of use information on the me-too label need not be identical to the format on the registered (cited) label as long as the critical information as described above remains the same and the me-too product meets applicable legal requirements on labeling.

        1. A major pitfall in side-by-side label comparisons is the possible presence of an unacceptable use or other error on the label of the cited registered product.

          1. If an error is discovered in the Directions for Use section of the cited, registered label, the reviewer must take the time to contact the registrant about the error(s) and request that the registrant submit a corrected label within a suitable time frame such as 30 days. Upon the Agency’s approval of the corrected label the registrant generally is provided with 18 months to sell or distribute existing stocks of the “old” label. 40 CFR 152.130(c). If there are risk issues associated with error, the Agency can issue an order under section 6 or 13 limiting the time by which the registrant can sell the existing stocks.

        2. If a Reregistration Eligibility Decision (RED) Document has been issued for the active ingredient in the product undergoing review, the reviewer must ensure that:

          1. all of the use sites on the label are in Appendix A of the RED;
          2. the site(s)/pest(s) are all eligible for Reregistration;
          3. if any one of the use sites is not in Appendix A, it may be a new use (see B.2. below) or an old use that (i) has been subsequently modified by the RED or deleted from labels as a risk mitigation measure or (ii) was not supported in reregistration. Products whose labels contain such uses may not be reregistered;
          4. if any of the uses have been declared ineligible for reregistration, the use may not be reregistered; and,
          5. if a favorable Reregistration Eligibility Decision document could not be made for any of the uses due to a lack of adequate relevant data, the product labels may be accepted as amendments to the registration if they are otherwise in compliance with the terms of the RED document.

            6. Further, if the product contains more than one active ingredient, all uses on the label must be acceptable for all of the active ingredients. For example, an ethyl parathion/methyl parathion product may only be used on the nine crops registered for ethyl parathion applications, even though methyl parathion is registered for use on additional crops. If there is more than one a.i. in the product and a RED is available for each, all sites on a label must be listed in each RED.

      2. Non Me-Too Applications. When a registrants’s application is not for a me-too product such as when a registrant proposes a new use, new application rate, preharvest interval (PHI) change, or a other action not previously approved by the Agency, a more extensive review than the simple me-too comparison is necessary. Such applications usually must be accompanied by relevant data and/or data citations, and should be sent for technical review. The “Directions for Use” on the proposed label may need to be altered due to the outcome of the science/technical review (i.e, use rates on crops, PHIs, reentry intervals, restrictions such as bee hazard warning statements, application rates and methods may have to be added or modified). The use rate, or application rate, may be the most difficult part of this section to interpret and review. Application rates, and number of applications per season for agricultural products may be affected by the residue data submitted or cited by the registrant. Approval of most agricultural uses requires that an appropriate tolerance be established because of the pesticide chemical residue on food.

    3. Analysis of directions for Use. Once the type of review has been determined for the submitted action, the label reviewer may proceed with an actual analysis of the Directions for Use section. The reviewer must not assume that because a registrant claims to be modifying only one part of this section that the rest of the directions for use are acceptable even though the label has been accepted in the past. A complete review is necessary because:

      • some labels may be very old,
      • previously accepted uses and language may no longer be recommended
        based on Agency guidance such as PR Notices
      • some changes may be unannounced.

        • Therefore, it is critical that the entire Directions for Use section be reviewed very carefully before accepting the label.

    4. Key Questions to be Answered when Reviewing the Directions for Use Section.

      The questions contained in the Label Reviewer’s Checklist (Section IX of this chapter) should be addressed when reviewing the Directions for Use section of the label. When answering these questions the reviewer should refer, as appropriate, to:

      • labels of substantially similar products for me-too applications,
      • to the RED (if there is one),
      • to the Registration Standard (if there is one not superseded by a RED), and
      • for new or revised uses, to any science/technical reviews, or the efficacy reviewer.
      • Current PR Notices must also be considered when using the Checklist. In addition, the CFR 40, Part 180 should be consulted for published tolerances, or use the Tolerance Index System (TIS) on the LAN.

        The “Directions for Use” section can become very complex depending on the sites and pests claimed. Individual Branches may have their own perspective on specific aspects of the “Directions For Use” section. PM/team leaders, efficacy reviewer and fellow reviewers are the best sources of such specific information to understand the contours of 40 CFR 156.10 and general policy statements.

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    III. Content

    1. Manufacturing-Use Product (MP). If the pesticide is an MP intended only for use by formulators preparing end-use products, the directions for use on the label may be greatly reduced in scope. See regulation at 40 CFR 156.10(i)(1)(c)(iii). However, these products must still have the following: 1) “Directions For Use” heading; 2) Misuse Statement(s); 3) The statement “For Formulation Into A [type of pesticide]” followed by a continued statement of the uses (crops/sites or other uses) for which the end-uses product (EP) may be registered and uses for experimental purposes that are in compliance with FIFRA. Any MP registrants wishing to do so may add one of the following statements to an MP label under “Direction for Use” to permit the reformulation of their product for a specific use or all additional uses supported by a formulator or user group:

      1. “This product may be used to formulate products for specific use(s) not listed on the MP label if the formulator, user group, or grower has complied with U.S. EPA data submission requirements regarding the support of such use(s).”

      2. “This product may be used to formulate products for any additional uses not listed on the MP label if the formulator, user group, or grower has complied with U.S. EPA data submission requirements regarding the support of such use(s).”

        In order not to confuse the user, products meant for manufacturing processes cannot also have directions for use as an end use product, as the regulations states that manufacturing use products must not get into the hands of the public except after incorporation into divided products. Note, in some cases an MP may be labeled for specific end uses as well as for manufacturing uses; generally, such products tend to be industrial-use products which may either be reformulated into EPs or incorporated into various materials to produce treated articles (e.g.,wood preservatives, in-can paint preservatives, etc). EPs may be used as an active ingredient source for other EP’s, but the label for such a source product may not include directions for its use as a MP and the label must bear the same sites as the EP formulated from it. Pesticide products used for manufacturing products which are not required to be registered (treated articles or substances, etc.) are considered to be end-use products. Labels for such source products must bear complete Directions for Use sections.

    2. Pesticide Product Intended for Use only by Physicians, Veterinarians or Pharmacists. Directions for Use sections on labels for products of these types may be very limited in content. However, this provision applies only when the product is also classed as a drug and regulated as such under the provisions of the Federal Food, Drug and Cosmetic Act (FFDCA) (see 40 CFR 156.10(i)(1)(iii)(B)(3).

    3. Typical End-Use Pesticide Products. The Directions for Use for typical end-use products may appear on the container label and/or, may be securely attached to the packaging as long as the container label makes reference to the attachment, [see 40 CFR 156.10(i)] and as long as the reviewer has determined that it is not necessary for such directions to appear on the container label and the label bears such as “See directions for use on enclosed brochure.”

      The manner in which information is conveyed in the Directions for Use section of many pesticide labels varies greatly from label to label. Within categories of pesticides, specific formats for the Directions for Use section may have been implemented through specific regulatory actions on products. Such formats take precedence over the general information presented in this section, but not over the requirements of 40 CFR, 156.10(i). As a result, the starting point for analysis of directions for use for EP is the regulations.

      For typical end-use products, the Directions for Use section will cover the following subsets of information:

      • standard requirements, such as the misuse statement, Worker Protection Standard boxes, etc.
      • lists of target pests for which control is claimed;
      • lists of permitted use sites;
      • restrictions and other limitations on use;
      • general information about the product and its use
      • specific application instructions
      • “Storage and Disposal” instructions

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    IV. Standard Requirements


    Special Reminder to Reviewers
    Not only should the Directions for Use section provide basic application information, its contents must also make sense. Any applicator, and especially the general consumer, who is a nontechnical and occasional applicator, should be able to easily understand and be expected to follow the directions for use.

    1. All standard elements and language required by FIFRA and the applicable regulations to appear in the Directions for Use must be placed on the label in the locations specified for them in FIFRA or the applicable regulations. These elements should always be presented on the label, in the following order:

      1. “Directions For Use Heading”
      2. Use Classification Statement
      3. Misuse and Related Statements
      4. Worker Protection Standard (WPS) Requirements (if applicable)

    2. Directions for Use Heading. The heading of the Directions for Use section of the label must be "Directions for Use." It may not have any other title. Headings such as "General Directions," "Use Directions," “Recommendations for Use,” “Recommended Uses,” "How to Use," or any other similar wording are not acceptable.

      The heading “Directions for Use” may be capitalized, put in bold type, and/or underlined to give it proper emphasis. The heading must be of such prominence and placement on the label that it is clear that all subsequent components of the section fall under the main heading “Directions for Use”. Such prominence can be assured by putting the heading in the largest, most conspicuous type that is used in the section and by centering the heading on the label panel while left-justifying all subheadings within the section.

    3. Use Classification Statement

    4. Misuse Statement. All registered pesticides, including all end-use and manufacturing use products, must bear labeling which has the following statement immediately below the Use Classification:

      "It is a violation of Federal law to use this product in a manner inconsistent with its labeling.

      1. Other statements relating to misuse, such as the following, are acceptable for residential/ household use products, and can be used in addition to and following the general misuse statement mentioned above:

        • “STOP! - Read the label before using”
        • “Use only as directed on this label”
        • “Read label very carefully, including any special requirements which pertain to your growing area.”
        • “Failure to follow all precautions and directions is illegal.”

      2. The general misuse statement to be used for experimental Use permits (EUPs), read as follows:

      “For Experimental Use Only” (40 CFR 172.6(a)(1)).

    5. Worker Protection Standard. The Worker Protection Standard (WPS) regulations (40 CFR Part 156, subpart K) require certain statements on the labeling of all pesticide products within the scope of the WPS. Required WPS statements should appear after “the general misuse statement” under the heading Agricultural Use Requirements (40 CFR 156.206). WPS statements generally include the subheadings General Statements, Restricted Entry Interval (REI), Notification to Workers Statements and Non-agricultural Use Requirements. Chapter 10 provides the information necessary to determine whether the label under review is subject to the requirements of the WPS and specifies how the WPS requirements must be presented on the label.

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    V. Application Information

    1. Content. This subset of the Directions for Use section should indicate use precautions and restrictions that apply to all sites and pests claimed on the label. For products with many registered uses, it may be useful and efficient to provide separate directions which pertain to specific subsets of the sites and pests combination claimed for the product. In such cases, each site and pest would have its own subsection which would be further divided into subsections such as “USE RESTRICTIONS” and the other elements specific to that grouping. Some requirements specific to how the products is to be applied might be more efficiently placed under subsections pertaining to applications rather than under “USE RESTRICTIONS”. The Use Restrictions subsection generally indicate the following:

      • the pests for which control is claimed;
      • the sites where the product may be used;
      • any FIFRA 2(ee) limitations statements;
      • other use limitations and requirements such as those statements pertaining to Chemigation, Spray Drift Labeling, seasonal restrictions, weather or time-of-day restrictions, requirements intended to protect nontarget species or contaminations of food or feed crops, and other basic requirements pertinent to safe and effective use of the product.

    2. Chemigation Information. Review of labels for agricultural uses, nursery uses, uses on golf courses, sod farms or in greenhouses should be conducted with reference to the guidance contained in PR Notice 87-1 (chemigation), unless the product is solely for residential use, direct injection into plants, post-harvest application, or is applied as a gas or solid (pellets, tablets, granules, or dusts). PR Notice 87-1 states that subject labels (as specified above) must either include the statement, "Do not apply this product through any type of irrigation system" or include labeling statements regarding chemigation contained in PR Notice 87-1 Any product used on agricultural sites that may be applied by chemigation should contain information such as the following:

      • Types of irrigation systems to be used;
      • Consequences of improper chemigation;
      • To whom questions about chemigation can be directed;
      • Warnings against connecting irrigation equipment to public water supplies without safety mechanisms;
      • Personnel required for adjustment of chemigation equipment;
      • Statements required for Toxicity Category I products;

        • Note: PR Notice 87-1 contains the complete wording of all the chemigation text categories indicated above. Check relevant REDs for any chemigation text specific to the active ingredient(s) in the product under review.

    3. Spray Drift Labeling. As this edition of the Label Review Manual is being issued, revisions to label language for Spray Drift are under way.

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    VI. Guidance for Wording Application Information.

    What goes in this subsection will vary considerably according to the type of pesticide product and the intended user.
    1. The Intended User. Although this information generally will not be stated specifically on the label, it is very important to keep the intended user of the product in mind when reviewing any pesticide label. For example, if the product is primarily intended for use by general consumers or "residential/household users" the application sites listed on the label should be appropriate for use on or in and around the home, yard, and garden, or on pets. Such sites might include, home flower or vegetable gardens, ornamentals (shrubs and trees), home lawns, or residential greenhouses.

      1. If the product is intended for use only by veterinarians, then the label must state that the product can only be used by veterinarians or physicians. The following statement is an acceptable one to meet this requirement:

        “This product may only be used by veterinarians/physicians.” 40 CFR 156.10(i)(1)(iii)(B).

      2. The phrases, “For use only by [a certain type of user]”; “For Commercial Use Only” or “For Professional Use Only” should not appear on a product label. Such statements are often used by registrants for marketing purposes, however, neither FIFRA nor the applicable regulations provide for labeling statements such as for “professional use”, ”industrial use” or other such terms. The registration process does not involve a determination that a product should be used, for example, only by “service persons.” Such statements are vague and they can mislead customers into believing that a product with such a statement is somehow more efficacious than another product. Such statements are also not likely to be enforceable under FIFRA.

        Note: The Agency can designate pesticides for “restricted use” if the Agency determines that the product may cause unreasonable adverse effects without additional regulatory restrictions. See FIFRA 3(d), see also 40 CFR Part 152 Subpart I. In that case, a restricted use product can only be used by a certified applicator. ( The regulations at 40 CFR Part 171 set out the requirements for certification of applicators.)

      3. If the product is a termiticide, then the Agency has historically taken the position that the label should contain the following statement:
      “For use by individuals/firms licensed or registered by the State to apply termiticide pesticide products. A State may have more restrictive requirements regarding qualifications of persons using this product. To find out how to legally use this product in your State, consult with your State’s Pest Control regulatory agency.”
      2. It should be noted that although some of the above mentioned statements restrict who can use the product, none of the statements restrict who may purchase the product, unless the pesticide is classified for restricted use. The only way to restrict sale of the product is through classification of the product as a Restricted Use Pesticide, as described in Chapter 6.

    2. The Pests being Claimed. The term pest is defined by statue and by regulation in FIFRA 2(t) and 40 CFR 152.5. The label must clearly state the pest(s) (associated with a site) that are controlled by the product. Pest claims may be made in the Use Restrictions section or with specific application instructions. In addition, pest claims often may appear on the front panel as part of the name of the product or in promotional statements appearing under the product’s name or elsewhere on the label.

      1. Consistency of Listed Pests. Wherever the pests are listed on the label, they must be consistent with pests listed elsewhere on the label. For example, if the front panel lists fire ants as a target pest, then the directions for use must include the appropriate treatment directions for fire ants. If the front panel lists several pests and then references other pests controlled by using phrases like “and more,” or “plus others” or “and many more,” these phrases will only be acceptable if they are followed by a direct reference to the Directions for Use section for the complete listing of pests controlled, i.e., “and more listed on the back panel.” The reviewer must make sure that the directions for use are actually included and are applicable to all pests listed anywhere else on the labeling. This consistency is necessary to ensure that the product is not considered misbranded.

      2. Pest Groupings. While target pests may be named very generally in the directions for use section of some labels (e.g., ants), other labels may identify them specifically, (e.g., carpenter ants). In the case of public health antimicrobial products, however, each strain of a pest listed on the label must be supported by appropriate efficacy data so that both the common and generic terms may be used if appropriate. The directions for use should be determined by and reflect the strain, location and behavior of the pest as closely as possible.

      3. Product Formulation and Pests. When evaluating the target pests it is important to keep in mind the relationships among pests, application methods, and product formulations. For example, a liquid formulation of a pesticide such as parathion restricted to foliar aerial application would be unlikely to control soil-inhabiting insects such as corn rootworm larvae. If the reviewer is unsure whether a formulation could be expected to control a certain pest on a label, the reviewer must consult with the appropriate efficacy reviewer(s). The applicant must be informed if the proposed use is not found to be acceptable. The applicant may appeal such a decision. Typically, the applicant would then be required to supply information (such as product performance data) to the Agency indicating that its formulation is appropriate for the proposed use.

      4. Pests and Use Sites. The pests listed on the label should be appropriate for the intended use sites for the product. For example, pests listed on the labels of residential/household use products should be typical household/garden pests. An agricultural crop specific pest such as the cotton bollworm would not be an appropriate pest claim for the label of a product intended only for use around the home.

    3. Where the Product is Used. All application or treatment site(s) must be identified on the label and clearly associated with the pest controlled. Many labels identify such sites near the beginning of the use directions (e.g., in the “Use Restrictions” subsection) and/or in the text which presents specific application directions.

      1. Consistency of Listed Sites. Wherever the sites are listed on the label, they must be consistent with sites listed elsewhere on the label. For example, if the front panel lists ornamentals as a site, then the directions for use must include the appropriate treatment directions for ornamentals.

      2. Complete Site Information. Treatment sites must be clearly identified. For example, if residential sites are listed as an application site, exactly where the pesticide is applied must be specified, for example, bathrooms, kitchens, etc. Reviewers should require the use of the most specific site terminology reasonable. If possible, refer to site indices in OPPIN to identify appropriate site terminology but avoid the use of site categories (e.g., “domestic dwellings”) that would be awkward or confusing on a label. The use of uniform site terminology is useful for the purposes of exposure reviews. The label reviewer may need to inform the registrant that the application sites need to be identified more specifically, for example, cracks and crevices in kitchen areas of residences instead of “dwellings”.

      3. Site Groupings. If the use site is indicated by a broad crop grouping, such as "ornamentals," the registrant should be instructed to specifically identify sites on which the product may be applied in the directions for use: “Ornamentals: Christmas tree plantings, conifer seed orchards, and rhododendrons." In this example, the product user is restricted to using the product only on those three use sites. However, if a use site were indicated as "Non-cropland industrial sites, such as, airports, fence rows, roadsides, and associated rights-of-ways," then the user could use the product on any place that would fall under the category as non-cropland industrial sites. Reviewers should not accept an open-ended site list, including those extended by “such as” or lists ending with “etc.”, where food uses may be involved.

      4. Site-Pest Considerations. Site-pest combinations must be appropriate. Pests for which control is claimed must occur as pests at the sites with which the label associates them. Claims for control of a pest on or at an inappropriate site could mislead the user and possibly result in a misapplication of the pesticide. Examples of inappropriate pest/site claims include: control of algae in toilet bowls and brown dog ticks in commercial kitchens. If such inappropriate site-pest combinations are detected during label review the registrant must be advised that such claims are unacceptable.

      5. Sites and the Intended User. The listed sites should be appropriate for the intended end-user. For example, sites listed on the labels of residential use products should be typical household/garden sites and not commercial agricultural sites such as cotton, tobacco, or cranberries.

    4. Use-Related Information. Any other appropriate information (precautions or restrictions) should be presented in the restrictions subsection unless such statements apply only to some of the uses permitted by the label, in which case the statements belong with directions for specific site and pest groupings. Use related information can include restrictions regarding the timing of application, weather, soil conditions, geography, or other relevant considerations. This information should be appropriate for the intended user(s), site(s), and pest(s) listed on the label.

      1. Liquid Spray Instructions. Labels for liquid formulations generally refer to “spraying” the product as the method of application. Labels which have directions which instruct users to mix a spray solution should provide special instructions devoted to preparing spray mixes and should indicate the spray volume to be applied per acre or per unit area. For some applications it may be acceptable for the label to indicate, "apply sufficient volume for thorough coverage" or similar language. The following types of spray applications are generally used:

        Space Spray - dispersal of the product into the air by foggers, misters, aerosol devices or vapor dispensers for control of flying pests and exposed crawling pests.

        General Spray. Application to broad surfaces, such as walls, floors and ceilings.

        Spot Spray. Application to small areas on which pests are likely to occur. These areas may be on floors, walls, bases or undersides of equipment. To limit potential exposure in a commercial food area, a “spot” should not exceed two square feet.

        Crack and Crevice. Application of small amounts of pesticide into cracks and/or crevices in which pests hide or through which they may enter a building. Such openings commonly occur at expansion joints, between elements of construction and between equipment and floors. If a label being reviewed uses any of the application terms mentioned above, determine if the terms are appropriate, considering the general use patterns on the label.

      2. Dust Formulations. For dust applications, a statement such as "apply uniformly for thorough coverage of plant surfaces" may adequately substitute for a specific application rate. However, a maximum application rate must be specified in order to avoid over-exposure.

      3. Aerial Applications. For aerial applications, spray volumes must be stated.

      4. Spreader Settings. Spreader settings may vary from product to product. Such changes in spreader settings are not usually considered significant.

    5. How the Product is Prepared and Handled. Complete information on how to prepare, handle and apply the pesticide product must appear on the label. In order to satisfy the unreasonable adverse effects standard of FIFRA, label reviewers will, on occasion, need to disapprove of or modify label language submitted by the application for registration. Such modification may take the form of specific prohibitions (“Do not apply this product by use of aircraft”) or general statements limiting use to methods indicated on the label (" Apply this product only by the methods listed and described on this label”).

      1. Formulation Type. Information regarding the product’s formulation is essential for the proper preparation, handling and application of a product. For example, the label must clearly identify the formulation type of the product (dry, liquid, bait, or a gas, such as certain fumigants). The label also must specify if the formulation is "ready-to-use" or a concentrate which requires dilution and /or mixing. Aerosols, dusts, baits, granulars, and some liquids are examples of ready-to-use formulations.

      2. Mixing Instructions. Some products must be mixed or diluted with other materials prior to application for pest control purposes. Labels for liquid formulation identified as concentrates, and dry products identified as “wettable powders,” must have directions for mixing or diluting. Mixing directions must be as clear as possible, and presented in easily measurable units (e.g., not "add 2.678 ounces to a gallon"). The units of measurement must be units by weight for dry formulations (pounds, ounces), and units by volume for liquids (pints, quarts, fluid ounces) or their standard abbreviations. One of the most frequent labeling errors observed is the use of "oz." for liquids instead of "fl. oz." Metric units may be used in parentheses after the correct English units. The diluent must be specified, even if it is water.

        Dilution instructions may be presented in the form of a chart or table. Basically, the dilution directions should state mix "X" amount of pesticide with "Y" amount of water (or other diluents such as oil) to achieve a particular dilution, such as a 1% emulsion.

        While the label may include a general statement such as “ Use sufficient water to obtain full coverage of foliage,” the label also should give specific directions for the use site to indicate the appropriate amount of spray volume to apply per unit area for aircraft or for ground equipment. It also may be necessary for the label to indicate the diluent spray volume amounts for aircraft or ground equipment.

      3. Methods and Types of Equipment. When necessary the label must indicate the types of equipment that may be used in applying the pesticide. The type of equipment should be identified in a level of detail sufficient to promote safe and effective use of the product. For example, ground and aircraft sprayers should be described by type and performance requirements (output and safety specifications) to the extent that such descriptions are needed. The same concept applies to, spreaders, injectors, burrow builders, and any other specialized equipment. Specific brands and models of equipment should not be indicated unless specific information is provided to indicate that only that brand and model are appropriate for reasons of safety or efficacy. Some types of equipment are designed specially to apply particular types of pesticide or to interface with particular containers in which certain especially hazardous products are packaged. Use directions should prohibit use of types of equipment known to be inappropriate for handling the product or any of the mixtures that the label directs users to prepare. When the method of application and necessary equipment are specific to each site and pest combination, they should be indicated in the directions that pertain to each combination. The label reviewer should make sure that the methods of application and equipment recommended are appropriate for the product formulation, the intended user, and the site and pest to which the pesticide product is being applied. Complete information on how to apply the product should be included. For example, the statement “Apply this product to the soil” is not sufficient. Labels which state that the pesticide must be applied to the soil and immediately incorporated, must specify what kind of equipment must be used.

    6. Use Restrictions. General, or non-site- specific, precautions, restrictions or limitations of the product comprise another important type of use restriction information in the Directions for Use section. Such a restriction may consist of an imperative sentence– practically any sentence that begins with a verb and ends in a period– or any other sentence which requires or forbids certain action (See Section III of chapter 3 for discussion of mandatory labeling statements). Use restrictions also may be phrased as requirements by using words such as “must”, “never”, and “always”. Any precautions and restrictions that apply to specific site(s) and pest(s), must be included in the directions specific to that combination. Use restrictions may be required by the Agency to meet the unreasonable adverse effects standard or proposed by the registrant or applicant. Such restrictions may include, but are not limited to, the following categories:

      • User Restrictions
      • Rate Restrictions or Limitations
      • Site, Pest, Timing, Weather, Soil, Geographic Restrictions
      • Equipment, or Application Method Restrictions
      • Miscellaneous Precautions such as Staining, Phytotoxicity, Incompatibility with Other Products, etc.
      • PHIs or Rotational Crop Restrictions (unless site-specific)

      1. Appropriateness of Precautions and Restrictions.

        1. The reviewer must carefully assess each restriction or limitation to make sure that it does not place on the product obligations that the user cannot reasonably carry out. For example, an aquatic herbicide for use in ponds and lakes might have a restriction like: “POTABLE WATER: Delay the use of treated water for domestic purposes for a period of three weeks or until such time as an approved assay shows that the water contains no more than 0.1 ppm [herbicide active ingredient].” Because any number of applicators could be using the product in public ponds or lakes used by many households or municipalities, the applicator may have no reasonable way of complying with such a restriction. Either another risk mitigation measure must be developed, or the product should be given restricted use status.

        2. Some proposed labels will contain various use restrictions desired by the registrant, (e.g.,“Do not tank mix this product with [their competitor’s products],” or “Do not use this product for formulating other products,” or other similar restrictions). Unless there is some risk based reason for such use restrictions, such statements are not generally acceptable on product labels because they are false and/or misleading. Labels may prohibit use of the product on certain crop varieties.

          When used in reference to the response of crops and weeds to the proposed pesticide product (e.g., a herbicide label), registrants should use the word "tolerant" instead of "resistant." For example, the label should refer to the use of the product on herbicide tolerant crops, not herbicide-resistant crops.

      2. Total Release Foggers. If the product label being reviewed is a total release fogger that contains a highly flammable ingredient, the following label text must be included in the Directions for Use, preferably with the general information:
        “DO NOT use more than one fogger per room. DO NOT use in small, enclosed spaces such as closets, cabinets, or under counters or tables. DO NOT use in a room 5 ft. x 5 ft. or smaller. Instead, allow fog to enter from other rooms. Turn off ALL ignition sources such as pilot lights (shut off gas valves), other open flames or running electrical appliances that cycle off and on (e.g., refrigerators, thermostats, etc.). Call your gas utility or management company if you need assistance with your pilot lights.”
      3. Compatibility With Other Products. EPA will not accept or require a label prohibition against the use of one pesticide product with another product unless that statement is necessary to protect human health or the environment, or to prevent illegal pesticide residues under Federal Food, Drug and Cosmetic Act (FFDCA). For example, a label statement prohibiting the mixing of products, if mixing would cause an explosive chemical reaction, would be acceptable. EPA will NOT accept a label prohibition against the use of one product with another which is not necessary to protect human health or the environment. When compatibility with other pesticides or liquid fertilizers is being addressed, the label should include specific instructions or recommend a jar test.

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    VII. Additional Application Information

    This subsection of the Directions For Use may be given any of several headings, including “Application directions”, “How to apply” (especially for household/residential-use), and “Baiting” as appropriate. In cases for which there is only one site/pest category but several application methods, it may be appropriate to have separate application subsections for each method (e.g., “Area-wide Spraying”; “Spot Treatment”, etc.). This subsection contains the specific instructions and information needed to apply the product on each relevant crop/site for each target pest. Directions may be grouped according to the sites and pests to be treated (e.g., broccoli, cabbage, cauliflower: cutworms, fall armyworms, cabbage loopers). If geographical restrictions are required, individual States or counties should be listed; geographical regions (e.g., Northwest) are unacceptable because they are not specific enough to be enforceable. Unique, detailed sets of application directions will be required for certain pests (e.g., fire ants, pocket gopher).

    Fungicide grouping may be used ONLY if all pests occur and are controlled on all of the crops in the group. Plant diseases are commonly specific to a site, (e.g., Black Spot on roses). Any geographic restrictions need to be included with their appropriate sites/crops. Additional information that may be included in these instructions, by site/crop and/or target pests, includes:
    1. Preharvest Interval (PHI). If required to meet the FIFRA standard, the PHI should be indicated as numbers of weeks or days. Other timing/application descriptions include preplanting, at planting, post harvest, dormant, or delayed dormant. If one of these timings is present, it should be so stated in the Special Directions Column. Preslaughter interval (PSI’s) should be expressed similar to the PHIs.

    2. Net Contents and Application Rate. The directions for use may not call for use of more than the net contents of the product’s container (i.e., if a granular product is packaged as a 1 lb. unit, its application rate should not require 200 lbs. of product). If the product is a liquid, the specified treatment rate should be fl. oz. or gal. per unit area. If a solid, the rate should be expressed oz. or lb. per unit area. [Note: Many labels of liquid formulations incorrectly omit the “fluid” (fl.) with the oz. when specifying application rate.]

    3. Other Information Pertaining to Specific Applications. Other information may include: method of application, equipment, application frequency (within the requirements for tolerance, appropriate for controlling pests, etc.), minimum volume of diluent for spraying for each type of equipment, application intervals, maximum amount of product or pounds a.i. per acre per application, or per season or year, phytotoxicity effects or warnings, number of applications per season and grazing or feeding restrictions. In cases where a maximim limit of a.i./crop, season, etc., is required, ensure that liquid products include a statement of weight/volume of either product or active ingredient.

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    VIII. Storage and Disposal Instructions

    Labels for pesticide products are required to bear labeling instructions for the storage and disposal of pesticides and pesticide containers. It is preferred that the Storage and Disposal instructions appear at the end of the Directions for Use section. Information about, and requirements for, Storage and Disposal instructions are given in Chapter 13. Also, please refer to PR Notice 2001-6 for further guidance.

    Appendix A - Label Reviewer's Checklist
    1. Does the label have the correct heading “Directions for Use”? Is the heading given sufficient prominence so that it is clear to the reader that the entire intended “Directions for Use” section falls under it?
    2. Does the product have the required Misuse Statement? If the product has additional misuse statements are they acceptable?
    3. Does the label contain complete Directions For Use? Or are the detailed directions for use omitted because the product is an MUP or for veterinary use or for use in non-pesticide manufacturing?
    4. Is the product subject to the WPS? If so, does the proposed label contain all the required, accurate WPS information as set forth in the regulations and the guidance in Chapter 10?
    5. Is there appropriate Storage and Disposal information on the label?
    6. Should there be a General Instructions and Information sub-heading and section on the label?
    7. Is the product subject to the guidance set out in PR Notice 87-1 (chemigation)? If so, is there adequate chemigation information or a chemigation prohibition statement?
    8. Does the label contain adequate spray drift labeling?
    9. Should there be a Use Restrictions sub-heading and section?
    10. Are the sites and pests identified? Are they identified consistently throughout the entire label?
    11. Is the formulation acceptable for this site/pest combination?
    12. If a RED has been issued, is the site eligible for Reregistration?
    13. Is all equipment (e.g. for mixing, loading or application) identified/specified and is the equipment practical for the user?
    14. Are adequate preparation and handling instructions included?
    15. Is the timing of the applications appropriate?
    16. Are all methods of application appropriate?
    17. Are General Precautions and Restrictions clearly presented as a group? Should they be?
    18. Are the application rates indicated? Are they appropriate and calculated correctly? Do they deviate from a standard use pattern?
    19. Are there appropriate tolerances or exemptions from tolerance to cover all food uses?
    20. Is the Pre-harvest Interval or Pre-slaughter Interval correct?
    21. Is the application frequency acceptable?
    22. Is the rate of application consistent with the packaging of the product?
    23. Are site specific precautions and restrictions clearly listed with each site/pest combination?
    24. If the product contains more than one active ingredient, are all the uses acceptable for all the active ingredients?
    25. Is there any unclear or ambiguous or contradictory language on the label?
    26. Are the Directions for Use presented in the most effective, clearly understood and efficient way possible? Could the label benefit from the use of chart or graphs?
    27. Has the appropriate RED(s) been checked for any required labeling?
    28. Are there any PR Notices that provide useful guidance?
    29. Are label statements worded appropriately as mandatory or advisory?
    30. Check 40 CFR 156.10 for further guidance.

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