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Pesticide Labeling Questions & Answers

Consistency Questions If you don't find an answer to your question on this page, submit your question here. You may also use this form to report any problems you encounter with the Label Review Manual. Provide your contact information if you need a reply. We may add your question to this page, if it is of general interest. (Note: Contact your Pesticide Product Registration Ombudsman for specific label issues about a single product). Your name: Your phone: Your email address: Your question or comment: Required Please enter the keyword "human" in the box below to help us stop spam:

These answers are not intended to create significant new guidance or require any changes to previously accepted labeling. The Agency will contact registrants directly about how to correct problematic labels as appropriate. Changes to EPA accepted labeling will only be required in accordance with standard agency procedures.

1. Advertising Claims
2. Antimicrobial Claims
3. Chemigation
4. Contract Manufacture
5. Crawl Spaces
6. Definitions of Terms
7. Distributors
8. Exception to Use in a Manner Not Permitted (FIFRA Sec 2ee)
9. Existing Stocks
10. General Labeling
    1. Use Classification
    2. Product Name
    3. Name and Address of Producer/Registrant
    4. Product Registration
    5. Establishment
    6. Misuse Statement
    7. Ingredient Statement
    8. Precautionary
    9. Environmental Hazards Statement
    10. Directions for Use
    11. Worker Protection Statement
    12. Storage and Disposal
    13. Unattached Labeling
11. Labeling from Web Sites
12. Miscellaneous
13. Multiple Products Packaged Together
14. NAFTA Labeling
15. Notifications
16. Packaging
17. Pesticide Exemption (FIFRA 25B)
18. Pictures and Logos
19. Repacked Products
20. Service Containers
21. Subject to FIFRA
22. Superlative Terms
23. Supplemental Labeling
24. Termiticides
25. Water Soluble Packaging

1. Advertising Claims

• May a label contain advertising for a registrant's other products? For example, may it show pictures of fertilizer and other pesticide products the registrant distributes and say "For More Lawn and Garden Products visit. . .(website)"? LC09-0284; 11/4/09

  Yes, this is allowed as you have described so long as the reference to other products is (1) not false or misleading and (2) does not detract from required label information. See FIFRA 2(q)(1)(A); (2)(q)(1)(E. If either condition is not met, the product is misbranded and cannot be sold or distributed. FIFRA 12(a)(1)(E). To avoid a product being misbranded, EPA suggests the following guidance for registrants when adding references (including pictures and/or website addresses) to other products including pesticides on a label:

  1. It should be very clear that those products are separate and distinct from the subject product, ie. such references to these other products should be clearly distinct from the required labeling of the subject product. It is especially important that reference to other products does not distract users from reading the labeled product's Directions for Use.
  2. The advertising should not contain mandatory language saying another specified product must be used in order to achieve control/relief. Any requirement that products be used in combination to achieve efficacy for a pesticide product must be part of the Directions for Use and must be evaluated by EPA as part of the granting of a registration.
  3. The registrant should understand that any reference to a website makes that website labeling and therefore subject to more searching EPA review than if it were not referenced.  Future versions of a website referenced on a label will also subject to the same review, though at this time the Agency does not require notification or approval of such changes.

  Please note that distributor products are not allowed to add claims to the label that have not been approved on the parent product's label. 40 CFR 152.132(d). Therefore, a distributor may not add advertising for its other products unless such advertising is also on the parent product's label.

• A lawn care operator (LCO) has advertising in a local newspaper advertising its service, claiming mosquito and other pest elimination from customer yards. At the bottom of the ad, it states "Safe." Is stating a service using a registered product is “safe” in an advertisement a violation of FIFRA or its associated regulations? (LC08-0177)

  Section 12(a)(1)(B) of FIFRA makes unlawful any sale or distribution of “any registered pesticide if any claims made for it as a part of its distribution or sale substantially differ from any claims made for it as a part of the statement required in connection with its registration.” The statement required for registration must include “a statement of all claims to be made for [the pesticide].” FIFRA 3(c)(1)(C). EPA generally has not allowed the use of “safe” in labeling because it has been considered to be false or misleading. 40 CFR § 156.10(a)(5)(ix). False and misleading claims make a product misbranded and sale and distribution of such product unlawful. See FIFRA §§ 2(q)(q)(A); 12(a)(1)(E). If use of the term “safe” has not been allowed in labeling and use of the term hasn’t been otherwise approved, use of “safe” in advertising the sale or distribution of a pesticide product would generally be considered to substantially differ from what was approved in the registration and sale or distribution of the pesticide would be unlawful under section 12(a)(1)(B) of FIFRA.

  It is important to point out, however, that Section 12(a) is limited to unlawful sale or distribution, which is defined in FIFRA 2(gg) to exclude "the holding or application of registered pesticides ... by any applicator who provides a service of controlling pests without delivering any unapplied pesticide to any person so served." See also FIFRA 2(e)(1). This limits EPA's authority to regulate advertising claims made by certain home lawn care service companies that do not sell or distribute pesticides but merely apply them. To the extent EPA lacks regulatory authority over advertising of services, however, the Federal Trade Commission's (FTC's) broad authority to regulate advertising provides a means to regulate and enforce against excessive or misleading claims made by lawn care operators. Therefore, lawn care operators that do not sell or distribute pesticides but make false or misleading claims about their services, may be subject to enforcement by the FTC.

2. Antimicrobial Claims

• I work for a state regulatory agency that regulates Day and Home care operations. We have a rule that requires our operations to use specific disinfecting solutions, one of them being a "commercial grade product that meets the EPA's standards for "hospital grade" germicide". In reviewing your website, it seems you do not use this term often. The term you use in "disinfectant". Are these two terms inter-changeable? Secondly, do you have a list of EPA- approved hospital grade germicides available? Is there another term our inspectors should be looking for? (LC09-0268; 8.13.09)

  EPA does not categorize disinfectants as “commercial grade” or “hospital grade.” In fact, those types of descriptors are generally considered as misleading with respect to the chemical’s composition and effectiveness (156.10(a)(5)(i) and (ii)) because such statements could lead purchasers to believe they are getting a more effective product which is not necessarily the case. On the other hand, an antimicrobial product label may bear instructions for use in the hospital or medical environment if, among other things, the product passes efficacy testing for such use(s). The efficacy testing guidelines for such products are contained in 91-2(d)(3) of Subdivision G of the Pesticide Assessment Guidelines. Specifically, to be registered for use in a hospital or medical setting (such as a nursing home, day care center, doctors office), the product must be approved as a broad spectrum disinfectant and also must be proven through efficacy testing to be effective against the nosocomial bacterial pathogen Pseudomonas aeruginosa. Additional claims may be made if testing against other specified microorganisms demonstrates that the product is efficacious. Information on efficacy testing for such products can be found in the Subdivision G testing guidelines and at http://www.epa.gov/oppad001/dis_tss_docs/dis-01.htm .

  We do not keep a list of EPA registered antimicrobial products that have been registered for use in hospitals.

  To assess whether products can be used in hospitals, your inspectors should look for disinfectant products with directions for use in hospitals.

• An antimicrobial sanitizer label contains directions for use on food-contact surfaces that require a one-minute contact time although the data requirement for such products specifies only a 30-second performance test. The FDA Food Code, which is used by state and local jurisdictions to develop their own food safety rules, allows as little as a 7-second exposure time under certain circumstances. Is it a violation of the EPA label to use the described sanitizer product in a commercial dishwasher with a 10-second final rinse time (the only contact time with the sanitizer is during the 10-second rinse)? LC09-0254; 6.26.09

  It is a violation to use a registered pesticide in a manner inconsistent with its labeling, FIFRA § 12(a))(2)(G). Therefore, it would be a violation of the label to use a registered sanitizer product at less than the contact time specified on the product label. The Food Code may provide a minimum exposure time where it applies but it does not supersede a pesticide’s labeling. In your example, the 10-second final rinse time is the only time during which the sanitizer contacts the surfaces it is sanitizing, therefore the sanitizer is being used inconsistently with its labeling which requires a one-minute contact time.

• Can a sanitizer spray be considered to be effective against microorganisms other than those specifically listed on the label if the manufacturer has data to back up the claims? (LC08-0234; 2.26.09)
  
  FIFRA section 12(a)(1)(B) makes it unlawful for any person to distribute or sell any registered pesticide “if any claims made for it as a part of its distribution or sale substantially differ from any claims made for it as a part of the statement required in connection with its registration.” Accordingly, to make lawful claims, including providing or referencing data in connection with the product's sale or distribution, that a sanitizer spray is effective against specific pests, a registrant must submit those proposed claims and supporting data to EPA for approval as a part of its registration package and obtain EPA approval of the proposed claims.

  FIFRA section 2(ee) does allow a user to apply “a pesticide against any target pest not specified on the labeling if the application is to the crop, animal, or site specified on the labeling, unless the Administrator has required that the labeling specifically state that the pesticide may be used only for the pests specified on the labeling after the Administrator has determined that the use of the pesticide against other pests would cause an unreasonable adverse effect on the environment.” It must be noted that with respect to antimicrobial pesticides targeted against human pathogens, 40 CFR Part 168.22(b)(5) states that EPA will regard as unlawful the placement or sponsoring of advertisements which recommend or suggest the purchase or use of a registered pesticide for an unregistered use even if the use would be permitted by FIFRA section 2(ee).

• An antimicrobial product uses materials from renewable resources.  Will EPA permit labeling to make claims regarding renewable, naturally derived, or biodegradable materials? (LC08-0187)

  - ____ material made from X% biodegradable _____
  - ____ made from X% biodegradable _____
  - ____ made from X% biodegradable materials
  - Made with biodegradable ______
  - Biodegradable ____ material
  - This product is biodegradable (with supporting data for the liquid _________)

  - ____ made from X% naturally derived ______
  - ____ material made from X% naturally derived ______

  - ____ material made from X% renewable ______
  - ____ made from X% renewable ______
  - ____ made from X% renewable materials

  Label claims are evaluated on a case-by-case basis when individual product labels are reviewed and registered. Claims regarding renewable, naturally-derived or biodegradable materials have historically been found to be not acceptable.  While these terms may be factually correct in describing some of the attributes of a product, these terms can be misinterpreted as claims that relate to the safety of the product and therefore may be misleading.  The terms “naturally” and “renewable” suggest that a particular product contains certain ingredients that are safer than other products that contain other ingredients.  EPA does not approve claims that suggest a pesticide is safe, and does not approve claims that could be considered misleading comparative claims about the safety of a product versus other products that do not contain these same ingredients. LC08-0187; 7.8.08

  The term “biodegradable” may be used in reference to the package or packaging of a product and if the registrant certifies that the package breaks down and they provide information to support it.  However, the Agency has not identified a test method that could reliably be used to determine the biodegradability of a pesticide product itself.  In addition, singling out only certain ingredients in a product as biodegradable would give a misleading impression to the user that the entire product is biodegradable.  The Agency does not presently have any guidance as to how to conduct a biodegradability study for pesticide products.
  
  
• Can a pathogen name (or any portion of a pathogen name) be included in the product name of a registered pesticide? (LC08-0128; 11/8/07)

  A pathogen name may be included in a product name if its inclusion does not make the product misbranded because the labeling is false or misleading.  See FIFRA § 2(q)(1)(A).  Although the Agency discourages the use of pathogens in a product name, product names are reviewed on a case-by-case basis.  If there is a concern that a name may be misleading (such as presenting a heightened efficacy claim), the Agency may require evidence that it is not misleading before we accept it. 

• Many antimicrobial products labeling indicate use on "highchairs" and "toys" but are ambiguous as to use directions.  Are "highchairs" and "toys" a food-contact surface or are they a non food-contact surface?  If "highchairs" and "toys" are a food-contact surface should there be indication in the label?  Since "highchairs" and "toys" come in direct contact with infants/small children hands and mouths, there should be specific directions in antimicrobial product labels to reduce the possibility of contact and ingestion of pesticides.  Infants/small children exposure to antimicrobial pesticides is not equivalent to adult. Defining "highchairs" and "toys" as a food-contact surface is a minor definition issue which could reduce "potential" pesticide exposure in a potentially vulnerable population (infants/small children). (LC07-0114; 9/24/07)

  The use of an antimicrobial on highchairs is considered to be a food use. However, the use of an antimicrobial on toys is treated as a non-food contact use.  The Agency has not typically required a separate set of use directions for use of antimicrobials on highchairs or toys because the rate, method of treatment, target pests and other parameters are the same as for treatment of other hard non-porous surfaces that are typically found on antimicrobial labels.  The Agency does assess indirect dietary exposure for uses such as counter tops, appliances, tables, utensils, food packaging and other areas where there may be incidental contact such as high chairs.  The Agency uses a FDA model www.cfsan.fda.gov/~dms/opa2pmnc.html , Chemistry recommendations, appendix I, II, III, IV, V) that takes into account application rates, residual solution, area of the treated surface which comes into contact with food, pesticide migration fraction and body weight.  In this assessment, the Agency determines whether an additional margin of safety for infants and children is needed.  The Agency also evaluates the use of antimicrobial pesticides on toys taking into account the mouthing contact (i.e., incidental oral contact) and the completeness of the data base on toxicity and exposure.  If the available data indicate that an additional margin of safety for infants and children is needed (susceptibility and sensitivity issues) then the Agency will apply it. 

• In regards to claims made by antimicrobial type pesticides, certain statements on labels require EPA registration (such as “kills,” “disinfects” and “sanitizes”). Does EPA consider the term “sanitary” (as in “leaves surfaces sanitary”) to be a pesticidal claim? (LC06-0012)
  
  The Agency considers the appropriateness of the use of the term “sanitary” on product labels on a case-by-case basis.  The Agency has generally interpreted the use of this term as implying a state of cleanliness, however, if, among other things, the use of the term implies a claim of antimicrobial properties, the term may be considered a pesticidal claim and if so the product must be registered in order for the product to retain the claim and be able to be lawfully sold or distributed in the U.S.  Other factors that may imply that a product’s intended use is for antimicrobial effect include whether the product is similar in composition to FIFRA-registered products that make antimicrobial claims and whether the product contains an ingredient at levels for which there is no functional reason other than pesticidal activity.

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3. Chemigation

• Is an apparatus of a pump connected to a bottle of concentrated pesticide, which in turn is hooked into a residential lawn irrigation system (sprinkler system) considered a chemigation device?  Can chemigation be referred to in a residential setting?  The pesticide used in this case is a 25(b) exempt product.  Could other registered conventional pesticides be used? (LC06-0064)

  The apparatus in question is application equipment that turns a residential lawn irrigation system into a chemigation system by introducing the pesticide into the irrigation system. Chemigation is defined in 40 CFR 170.3 as “the application of pesticides through irrigation systems.”  While this regulatory definition is exclusive to agricultural settings, it is reasonable for the Agency to apply it to similar situations outside of agricultural settings such as in residential lawn irrigation systems.  Thus the Agency would consider use of the apparatus described above as a chemigation application.   To the extent that a label prohibits the use of a product in a chemigation system, the label prohibition must be followed. 

  Chemigation has also been addressed in the agricultural setting through PR Notice 87.1, but this notice specially states that it does not apply to any pesticide product intended solely for residential setting.  However, the scope of the PR Notice was limited based on the information the Agency had on the extent of chemigation as a practice at the time.  The agency is currently reviewing PR Notice 87.1 to update in accordance with changing practices and will be putting a draft out for public comment.

4. Contract Manufacture

• Our company is looking at a repackaging project that involves receiving end-user household-type pesticides that have been returned to the retailer from which they were purchased. Assuming permission has been granted from the original registrant, can the product be repackaged and labeled with a trade name other than the original product/trade name without having to re-register the formulation? (LC06-0053)

  A repackaged product may be labeled with a trade name other than the original product trade name without having to re-register the formulation only if the registrant has registered the alternate brand name for that particular product registration and your company is operating under a contract with the registrant that allows you to relabel with an alternate brand name.  In addition, repackaging must occur at a registered establishment in accordance with 40 CFR Part 167.

• Is it true that all product produced at a contract manufacturer should carry a statement 'Produced for Company X? Or since the contract manufacture is working for the registrant, is the 'producer' really the registrant - meaning that the label does not need to carry the 'Produced for Company X'? (LC06-0022)

As stated in the Code of Federal Regulations section 156.10(c) "If the registrant's name appears on the label and the registrant is not the producer, or if the name of the person for whom the pesticide was produced appears on the label, it must be qualified by appropriate wording such as "Packed for * * *," "Distributed by * * *," or "Sold by * * *" to show that the name is not that of the producer."

In this case, the registrant is not the producer, irrespective of the contract manufacturing arrangement. The contract manufacturer is the producer of the pesticide, and therefore the registrant's name must be qualified with either the statement "Produced for * * *" or "Manufactured for * * *."

5. Crawl Spaces

• Cleanout and disinfection of crawl spaces (area underneath houses) is a new service being provided by a number of PCO companies.  We are having difficulty determining whether disinfectants can legally be used in crawl spaces.  Often the sites on disinfectant labels are very broad and seem to allow treatment in any area of a structure (including the crawl space), but then the specific directions only cover areas with non-porous surfaces inside of a structure.  It would be helpful for EPA to address this new use pattern and in the meantime we would appreciate some guidance on when disinfectants with current labels can be used in crawl spaces. (LC08-0176; 10/18/08)

  The Agency does not have a standard definition for crawl spaces.  As a result, the user must refer to the label of the disinfectant product to determine whether the product can be used to treat crawl spaces.  Typical components of a crawl space include ground and bare wood.  The Agency considers these surfaces to be porous surfaces.  These types of surfaces cannot be treated unless the label contains directions that would allow the product to be used to disinfectant porous surfaces.  If the label has language limiting applications to hard non-porous surfaces, application to a crawl space with porous surfaces would not be permitted.  
  

6. Definitions of Terms

• I am trying to find the definition or examples for the areas allowed in food-handling establishments versus the non-food areas. I am also searching for the definition of spot treatment. (LC08-0223; 1.28.2009)
  
  EPA published definitions and policies related to food-handling establishments in the Federal Register on August 10, 1973, available at 38 FR 21685. The notice defined a food handling establishment as “an area or place other than a private residence in which food is held, processed, prepared and/or served.” Food areas "include areas for receiving, serving, storage (dry, cold, frozen, raw), packaging (canning, bottling, wrapping, boxing) preparing (cleaning, slicing, cooking, grinding), edible waste storage, enclosed processing systems (mills, dairies, edible oils, syrups). Non-food areas include garbage rooms, lavatories, floor drains (to sewers), entries and vestibules, offices, locker rooms, machine rooms, boiler rooms, garages, mop closets, and storage (after canning or bottling).” The notice also defines spot treatment as “application to limited areas on which insects are likely to occur, but which will not be in contact with food or utensils and will not ordinarily be contacted by workers. These areas may occur on floors, walls, and bases or undersides of equipment. For this purpose, a ‘spot’ will not exceed 2 square feet.”
  
  
• Can you provide a definition of high level and low level disinfection. I have looked all over your site. There is the disinfectant definition, but it does not explain this. (LC08-0225; 1.28.09)
  
  EPA does not have a definition for high and low level disinfection. These are terms used by FDA. You can find further information at http://www.fda.gov/cdrh/ode/397.html .
  
  
• Does EPA recognize 29 CFR 1910.133 and (by reference) 1910.6 as the standard for labeling required safety glasses? (i.e safety glasses need to be ANSI-approved and carry an ANSI number). If not, do you recognize any standard for safety glasses or can users use any type of glasses that have brow and temple protection? (LC08-0229; 1.28.2009)
  
  According to the worker protection standard and 40 CFR §170.240(7) (Protective Eyewear): “When “protective eyewear” is specified by the product labeling, one of the following types of eyewear must be worn: (i) goggle; (ii) face shield; (iii) safety glasses with front, brow, and temple protection; (iv) full face respirator.” If no more specific instructions are included in the directions for use, any safety glasses with front, brow, and temple protection would be allowed. While the OSHA regulations you cite do not technically apply to pesticide users, EPA strongly recommends following the OSHA guidelines when choosing safety glasses.

• A pesticide dealer copies mixing directions from a product label, puts them on a sticker, and puts the sticker on the products he sells. He also puts a sticker with his business address on the containers. Does either sticker misbrand the products? (LC08-0232; 2.26.09)

  Both activities are unlawful presuming the dealer is not acting with the permission of the registrant and in accordance with various regulatory requirements. FIFRA § 12(a)(2)(A) states that it is unlawful “to detach, alter, deface, or destroy, in whole or in part, any labeling required [under FIFRA].” Putting the copied mixing directions on another product is considered labeling and must be done in a registered establishment and in accordance with the registration of the product to which the sticker is added. If the product getting stickered doesn’t include the sticker information as part of its approved labeling, the product would be misbranded.

• Pesticide/fertilizer labels in certain states must have a label attached to the package, which includes an acceptable internet statement (e.g.  "Information regarding the contents and levels of metals in this product is available on the internet at: http://www.aapfco.org/metals.htm.)  Is it legal for a supplemental distributor to add the internet statement on their supplemental distributor fertilizer/pesticide product labels when the master EPA label does not have this statement? (LC08-0197, 10/30/08)

  The label of a distributor product must be identical to the master label of the parent product, except as provided in 40 CFR 152.132(d).  A supplemental distributor may not add statements such as that proposed in the question unless the master label of the parent product is amended to include the statement

• If a registered pesticide label is distributed in both the USA and in another country does the Agency allow both the USA Distributor Company's Division Name & address and the International Distributor Company's Division Name and address on the same supplemental label? (LC08-0193)

  40 CFR 156.10(a)(1)(ii) requires that the name and address of the producer, registrant, or person for whom produced appear on the label.  Further 40 CFR 156.10(c) requires that if the producer is not the company listed in the name and address on the label, the name and address must be qualified by a phrase such as “Distributed by,” “Produced for,” or “Sold by” to show that the name appearing on the label is not that of the producer.  So long as the qualification is not false or misleading,  the international distributor’s name and address may be added to the label if it is properly qualified by a phrase such as “Distributed Internationally by” or “International Distributor:”. See FIFRA sec. 2(q)(1)(A).

• Our company imports a commodity chemical from outside the US into a public warehouse.  One end-use of the chemical is as an EPA-registered pesticide.  The quantity of this chemical that we currently have in stock at the public warehouse is not labeled.  When we receive an order for the EPA-registered pesticide, the warehouse labels packages of the product with the registrant’s label and ships it to the customer.  The registrant provides the necessary labels for the warehouse to affix to each package.  Do we as the distributor need to be registered in order to direct our third-party public warehouse (physically in possession of the product) to affix the labels on the registrant's behalf?  Or does the warehouse need to be registered, or both? ( LC07-0120)

  The person doing the labeling must be doing so under the instruction of the registrant but does not have to be registered.  In contrast, the warehouse where the labeling is taking place must be registered as a pesticide producing establishment since labeling is defined as production of a pesticide and all pesticide production must take place in a registered establishment.  See 40 CFR Part 167.  The establishment number of the warehouse where the labeling is taking place must appear on the label of the product.  40 CFR 156.10(a)(1)(v).  You may obtain an establishment registration for the warehouse by contacting the EPA Regional office which has jurisdiction over the state where the warehouse is located.  For more information on the establishment registration process and reporting obligations see:  http://www.epa.gov/Compliance/monitoring/programs/fifra/establishments.html.

• Is it acceptable for a Supplemental Distribution of a Registered Pesticide Product form to have two distributor product names listed in the box (e.g. XXX Algae Relief and Algae Pond Relief)?  In the past, each distributor product has had its own form.  (LC07-0105)

  In accordance with 40 CFR 152.132(a) each distributor must complete a signed Notice of Supplemental Distribution of a Registered Pesticide Product (EPA form 8570-5), however, the form can contain more then one brand name. So, it is possible for a distributor to list two product names on the form.  The names would have to be for the same registered product and be submitted by the same distributor.

• My questions are in regard to a combo product, a fertilizer with a pesticide on it. When sub-registering a product, and the Primary label mentions "spreader settings" on the label, is it a requirement for the sub-registered label, to carry this same statement about what the settings should be, or is it permissible to include a general statement of contacting the spreader manufacture for up to date settings for the product, due to the large amount of spreaders and possible changes, and also since "spreader settings" is not a FIFRA or 40 CFR label requirement? (LC07-0086)

  A distributor label under Supplemental Distribution must be the same as that of the registered product except for a limited set of exceptions,  40 CFR 152.132(d).  Directions for Use are not excepted and must be identical to those of the registered product.  Therefore, the “spreader settings” of the parent registered product must be used on the Distributor label, being a part of the Directions for Use.  If the distributor label included any additional text not included on the registered product label, it would not be the same as the registered label, and thus in violation of the regulations.

• May distributor labels differ from EPA-accepted labels? (LC07-0089)
  
  40 CFR 152.132(d) requires that "the label of the distributor product is the same as that of the registered product" with certain listed exceptions such as the product name, registration number and establishment number. In addition, claims may be deleted for the distributor label provided no other changes are necessary (40 CFR 152.132(d)(5)).
  
  
• In situations where a product is produced by a contract manufacturer as well as the registrant, could the registrant preface his name and address on the label with the term "produced for" regardless of whether he is the producer or the contract manufacturer is the producer of the pesticide? (LC06 -0059)

  A registrant may qualify his name and address with the term "produced for" regardless of who is the producer of the product.  The registrant may also qualify his name and address with the terms "Sold by" or "Distributed by," which are equally acceptable.  See, generally, 40 CFR 156.10(c).

• Can a product label list the distributor's name and address on the packaging label in the absence of the distributor's company number appended to the product registration number?  The product is not "sub-registered" to the distributor, but is an alternate brand name, with the ABN including the distributor's name. (LC06-0052)

  A product label may list a distributor's name and address on the label without the distributor's company number appended to the product registration number.  If the distributor is not the producer of the pesticide, the distributor's name and address must be qualified as required in 40 CFR part 156.10(c).

• Is it a violation of FIFRA if the literature accompanying a supplemental distributor label lists more microorganisms than those listed on the distributor label even if the organisms listed in the literature are also listed on the EPA-approved master label? (LC06-0035)

  No, it would not be a violation of FIFRA.  With some exceptions, not relevant here, 40 CFR 152.132(d) requires that the label of the distributor product be the same as that of the registered product.  The term "label" is defined as "the written, printed, or graphic matter on, or attached to, the pesticide or device or any of its containers or wrappers."  FIFRA sec. 2(p)(1).  The more expansive term "labeling" is defined as "all labels and all other written, printed or graphic material." that accompanies a pesticide or device at any time or to which reference is made on the label or in literature accompanying the pesticide or device.  FIFRA sec. 2(p)(2).  As long as the EPA-approved master label for the registered product lists these pests, the supplemental distributor can market its product with those approved uses, claims, etc.

• Is it a violation of FIFRA if the literature accompanying a supplemental distributor label lists more microorganisms than those listed on the distributor label even if the organisms listed in the literature are also listed on the EPA-approved master label? (LC06-0035)
  
  No, it would not be a violation of FIFRA.  With some exceptions, not relevant here, 40 CFR 152.132(d) requires that the label of the distributor product be the same as that of the registered product.  The term "label" is defined as "the written, printed, or graphic matter on, or attached to, the pesticide or device or any of its containers or wrappers."  FIFRA sec. 2(p)(1).  The more expansive term "labeling" is defined as "all labels and all other written, printed or graphic material." that accompanies a pesticide or device at any time or to which reference is made on the label or in literature accompanying the pesticide or device.  FIFRA sec. 2(p)(2).  As long as the EPA-approved master label for the registered product lists these pests, the supplemental distributor can market its product with those approved uses, claims, etc.
  
  
• A company is proposing to distribute a pesticide product which currently has an EPA registration number.  On the front of the label, they would like to indicate their brand and on the back of the label, they would like to indicate a "Distributed by" notation with the address of the distributor.  First, can they do this without reregistering the product?  Second, does a distributor number need to be included and if so, how does a distributor become registered (and is it a per-product registration)? (LC07-6-0007)

  The distribution or sale of a registered product under a distributor's name and address is called "supplemental distribution."  The requirements for supplemental distribution are set out in 40 CFR 152.132. The product can be distributed as a distributor product without a separate FIFRA section 3 registration.  The distributor would need to be a registered company with their own company number - that company number would be used on all their distributor products.  Their EPA Registration number on the distributor products would look something like this:  EPA Reg. No. xxx-xxx-xxx or [parent company, number]-[product number]-[distributor company number].  The company numbers may be acquired through the nearest EPA regional office, or by written request to OPP.  The Label Review Manual provides a more detailed explanation of supplemental distribution process in Chapter 14-1, Section III.

• If a distributor sells a pesticide with another registrants name and EPA information on the container, can that distributor apply a tag or label stating:
  
  Sold By:
  XYZ Distributors
  Anywhere, USA
  
  This information would only be used to identify where the consumer may have purchased the product. An example might be a garden center selling "Round-Up" Weed Killer and applying a small sticker to the side of the container with his name and phone number on it. (LC06-0024)

  A distributor may not place a tag or sticker to a product as this is considered labeling and the product would be considered misbranded.

• Can a box of twelve pesticides be shipped by a formulator to a private-label distributor unlabeled? EPA-approved private labels are affixed by the distributor upon receipt? Would the box need to be relabeled? (LC06-27)

  A formulator may ship unlabeled pesticides to a private label distributor provided the pesticides are transferred to a registered establishment and the conditions of 40 CFR Part 152.30(b) are met. The private label distributor may label the products under a contract manufacturing agreement with the registrant of the pesticide product. The container the unlabeled pesticides are shipped in must bear the label of the registered product.

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• Do FIFRA 2(ee) recommendations generally include rate of application requirements or is the user bound by label directions? For example, if a 2(ee) recommendation for a product applied to a pest includes a 2% use dilution recommendation, can it be applied at 5% use dilution if 5% is an allowable rate on the label? LC09-0276; 8.13.09

  A FIFRA 2(ee) recommendation may be made for a number reasons, one being the application of the pesticide at less than the label dosage, concentration or frequency. An applicator may apply the product at the use dilution listed on the label or at a lesser use dilution listed in the 2(ee) recommendation. A FIFRA 2(ee) recommendation is just that, a recommendation. An applicator has the option of applying a product at less than the use dilution listed on the label unless the label specifically prohibits such dilution. Note that for antimicrobial pesticides targeted against human pathogens, it is unlawful for any person selling or distributing these products to advertise uses permitted by FIFRA 2(ee).  See 40 CFR 168.22(b)(5).

• Is placing mothballs outside on the grass along a fence line to repel cats an illegal use of mothballs? LC09-0269 and LC09-0270; 6.26.09

  Generally, it is unlawful to use any registered pesticide in a manner inconsistent with its labeling under FIFRA sec. 12(a)(2)(G). At present, there are no registered pesticides containing the active ingredients in moth balls that are approved for use in repelling cats. The FIFRA section 2(ee) definition of "to use any registered pesticide in a manner inconsistent with its labeling" provides for certain exceptions under which use is lawful. For example, it is not unlawful to use a registered pesticide "against any target pest not specified on the labeling if the application is to the crop, animal, or site specified on the labeling..." This exception would not allow application of mothballs along a fence line because registered mothballs products specify the use site as "air-tight containers and storage closets." Because applying mothballs to a fence line would not be applying them to a site specified on the labeling, such use is unlawful.

• Our specific question is in regards to the use of mothballs as a general animal repellent.  We frequently encounter people who use mothballs (in an attic, in a crawl space, in the garden, etc.) to repel such animals as skunks, raccoons, opossums, etc.  We inform them that this manner of control does not consistently work, and therefore, we cannot recommend it.  We also would like to be able to tell them if using this chemical in this manner is illegal - in reference to the terminology found on any chemical/pesticide product that "It is a violation of Federal law to use this product in a manner inconsistent with its labeling."  We are having trouble sorting through the information you provide on Use in a Manner Inconsistent with Its Labeling (FIFRA Sec 2ee).  This question can also apply to such things as ammonia, bleach, kerosene, gasoline, etc. that people pour in or around such described areas (aside from the obvious that using flammable chemicals in such fashion is dangerous) - the ultimate question is "Is it illegal?"  Please advise, as we are anxious to provide our cooperators with the most accurate information.  (LC08-0190)

  Using a registered pesticide like mothballs against a pest not listed on the label is legal unless (1) the pesticide is used on a site not specified on the labeling or (2) the label specifically restricts the pests against which the pesticide may be used (e.g. “for use only against ants”).  This is an exception to the definition of “use of a pesticide in a manner inconsistent with its labeling” in FIFRA section 2(ee)(2) which reads in part:  “…except that the term shall not include…(2) applying a pesticide against any target pest not specified on the labeling if the application is to the crop, animal, or site specified on the labeling, unless the Administrator has required that the labeling specifically state that the pesticide may be used only for the pests specified on the labeling after the Administrator has determined that the use of the pesticide against other pests would cause an unreasonable adverse effect on the environment,...”  The other substances you list may be both registered for pesticidal use or available unregistered for non-pesticidal uses.  While the Agency does regulate the sale and distribution of unregistered pesticides, it does not regulate the personal use of unregistered pesticides.  The personal use of products that are not registered pesticides – such as ammonia, bleach, kerosene, gasoline – may be dangerous, but it is not a violation of FIFRA.

• A rodenticide label says a block weighs 1 pound and is scored to be broken into 8 pieces, which means only 1 2oz piece of the block is to be used per bait placement.  Most of the time, 2 oz. is too much.  The manufacturer says it can be used in smaller quantities based on FIFRA 2(ee). Is this correct? (LC08-0179)
  
  Section 2(ee)(1) allows applying a pesticide at any dosage, concentration, or frequency less than that specified on the labeling unless the labeling specifically prohibits deviation from the specified dosage, concentration, or frequency.  So if the label at issue does not prohibit breaking the 2 oz pieces into smaller pieces, lesser amounts may be used.

• Section 2(ee) states an application of "a pesticide against any target pest not specified on the labeling" is allowed as long as the site is identified on the label. This text and meaning is very straightforward. However, EPA's interpretation and action in this regard appears to be based on tighter, unknown criteria or  restrictions. Section 2(ee) says one thing but EPA appears to act differently. An example is Sevin / carbaryl that is labeled for turfgrass. EPA interpretation is that “turf-sited” Sevin / carbaryl cannot be used for the control of earthworm pests in turf? Why not? FIFRA Section 2(ee) text allows this usage.  Thank you." (LC07-0107; 9/24/07)

  Section 2(ee) allows the use of a pesticide against any target pest not specified on the labeling as long as the site is identified on the label and there are no other label restrictions that would preclude use against the pest.

• Are there any stipulations on who can make a FIFRA 2(ee) recommendation?  Can a user make a recommendation?  Can the manufacturer make a recommendation to use a pesticide in a manner that would be allowed under 2(ee)?  Is there any entity that cannot make a 2(ee) recommendation? (LC06 - 0056)
  
  On October 22, 1981, EPA published a notice in the Federal Register (44 FR 51745) entitled "Advocacy of Pesticide Uses Which Do Not Appear on Registered Pesticide Label; Statement of Policy" which addresses who may legally recommend or advertise uses under section 2(ee)(1-5) of FIFRA.  The notice states the any person can make a recommendation under FIFRA section 2(ee)(1-5).  A subsequent FR Notice (51 FR 19174) dated May 28, 1986, amended the Agency's previous position by stating that persons may not make claims under section 2(ee) for antimicrobial pesticide products targeted against microbial human pathogens. 
  
  
• Regarding FIFRA section 2(ee) recommendations; is there a recommended expiration period (e.g., 1 year, 5 years)? Does this need to be added to the recommendation? (LC06-0015)
  
  There is no recommended expiration period for a FIFRA section 2(ee)(1)-(5) recommendation.
  
  
• What is the proper/legal way that FIFRA section 2(ee) bulletins can be distributed by extension services, universities or others? Can they be displayed with the product? (LC06-0011)
  
  FIFRA section 2(ee) bulletins are recommendations, allowed by section 2(ee)(2) of FIFRA, advocating use of a product on a pest not specified on the labeling if the pest is on a site listed on the label and the agency has not required labeling that only allows use on specified pests. FIFRA section 2(ee) bulletins may be distributed by virtually any means; i.e., through extension personnel, industry representatives, at the point of sale, displayed with the product, or downloaded off the Internet, provided the bulletin is factually correct and conforms to the restrictions of section 2 (ee). EPA does not allow 2(ee) bulletins for antimicrobial products with public health claims (i.e., targeted against human pathogens, 40 CFR 168.22(b) (5)) or other products with such claims. FIFRA section 2(ee) reads as follows:
  
  

  "(ee) TO USE ANY REGISTERED PESTICIDE IN A MANNER INCONSISTENT WITH ITS LABELING.-The term ''to use any registered pesticide in a manner inconsistent with its labeling'' means to use any registered pesticide in a manner not permitted by the labeling, except that the term shall not include (1) applying a pesticide at any dosage, concentration, or frequency less than that specified on the labeling unless the labeling specifically prohibits deviation from the specified dosage, concentration, or frequency, (2) applying a pesticide against any target pest not specified on the labeling if the application is to the crop, animal, or site specified on the labeling, unless the Administrator has required that the labeling specifically state that the pesticide may be used only for the pests specified on the labeling after the Administrator has determined that the use of the pesticide against other pests would cause an unreasonable ad-verse effect on the environment, (3) employing any method of application not prohibited by the labeling unless the labeling specifically states that the product may be applied only by the methods specified on the labeling, (4) mixing a pesticide or pesticides with a fertilizer when such mixture is not prohibited by the labeling, (5) any use of a pesticide in conformance with section 5, 18, or 24 of this Act, or (6) any use of a pesticide in a manner that the Administrator determines to be consistent with the purposes of this Act. After March 31, 1979, the term shall not include the use of a pesticide for agricultural or forestry purposes at a dilution less than label dosage unless before or after that date the Administrator issues a regulation or advisory opinion consistent with the study provided for in section 27(b) of the Federal Pesticide Act of 1978, which regulation or advisory opinion specifically requires the use of definite amounts of dilution. "

  
  
• Is there a required permit/process for an applicator to use, or a dealer to recommend the use of, a pesticide in accordance with FIFRA Section 2(ee)? (LC06-0036)
  
  There is no required permit or process to obtain or undergo in order to use a product or recommend use of a product under Section 2(ee)(1)-(5) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).
  
  

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• 40 CFR 152.130 and the Existing Stocks Policy (56 FR 29362) create a general 18-month period to distribute or sell products with existing labeling following approval of a voluntarily amended label.  Frequently EPA’s approval of the voluntarily amended label will direct the registrant to use this newer language at the next production or within 18 months.  New production after the 18-month window requires that labels use the newer text.   However, in many instances certain states (CA/NY) may take significantly longer to approve the newer text.  (LC07-0094)

  1) Can registrants continue printing older version label language (at the next production but within the 18-month window) until the newer label text is approved by CA and/or NY?  

  2) Can registrants continue printing older version label language after the 18-month window if the newer label text has not yet been approved by CA and/or NY. 

  3) Does the term "new production" refer to the production of the label or the production of the pesticide product.

  40 CFR 152.130 discusses distribution under approved labeling.  The Existing Stocks Policy further elaborates on the requirements of 40 CFR 152.130.  If labeling is amended on the initiative of the registrant, the registrant may distribute or sell under the previously approved labeling for a period of 18 months after the approval of the revision.  The Agency may alter the time period for distribution or sale under the approved labeling in which case the registrant must comply with the EPA mandated time frames. 

  1) A registrant may distribute or sell a pesticide under previously approved labeling until the 18-month time period has expired.  After 18 months the pesticide must bear the newly registered labeling.  The 18-month time frame is independent of state registration status of a product.
   
  2) Registrants may not continue to label products with old labels after the 18-month period regardless of the registration status of the product in a particular state.

  3) The term “new production” generally refers to production of the pesticide product.  If the new label cannot be printed in time to coincide with new production of the pesticide product and the production is within the 18-month time period, old labels may be used, however supplemental or sticker labeling bearing the newly approved labeling must be used after the 18-month date to bring the product into compliance.      

• 40 CFR 152.30 and the Existing Stocks Policy (56 FR 29362) create a general 18-month period to distribute or sell products with existing labeling following approval of a voluntarily amended label.  New production after the 18-month window requires that labels use the newer text.  Must the new label text be employed at retail bulk sites after 18 months, even if the manufacturer has not implemented the new label for non-refillable packages because no new manufacturing of the formulation has occurred since approval? (LC06-0060)
  
  Regardless of whether the registrant has engaged in new production during the 18 months, any new production after 18 months must bear the new amended labeling.  Repackaging is considered production therefore pesticide product repackaged into refillable containers must bear the new amended labeling.
  
  
• When a registration is transferred, what is the existing policy for product labeling/produced in the "old" EPA registration number to be used up?  (LC06-0009)
  
  Generally, the new registrant may distribute or sell under the previously approved labeling for a period of 18 months after the effective date of the transfer. The Agency specifies the time period in its letters of transfer.  See 40 CFR 152.130(c)  and 152.135(e) or Chapter 15-2 of the Label Review Manual.

10. General Labeling

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11. Labeling from Web Sites

• Currently pesticide users must use the label on the container, or use an official Supplemental Label (for example a new crop use was recently added). What is EPA's stance on growers downloading entire Section 3 labels from a web site such as CDMS, and using those directions? (LC07-0090)

  EPA directs users to follow the use directions found on the label of the container and in any EPA-approved supplemental labeling of the pesticide they are applying that accompanies the pesticide.  Labels acquired from web sites may not be the most current label or may conflict with the label on the container.  Because the label on the container is the label that must be followed along with any EPA-approved supplemental labeling which must accompany the user at the time of application, users should not download entire section 3 labels for use. 

• Are there any data requirements for making plant health and yield increase claims on a pesticide label? LC09-0271; 6.26.09

  Currently there are no data submission requirements specified for claims related to plant health or yield increases. EPA considers these types of claims to be efficacy claims and does not routinely require applicants to submit efficacy data for pesticides intended to control plant pathogens, non-public-health insect pests or weeds. While submission of data is not generally required for non-public-health pesticides,” 40 CFR 158.400(e) states "each registrant must ensure through testing that his product is efficacious when used in accordance with label directions and commonly accepted pest control practices." In other words, testing to ensure efficacy is required but data need not be submitted to EPA for non-public-health pests. EPA may, on a case-by-case basis, require submission of such efficacy data for non-public-health pesticides when necessary to evaluate whether the pesticide meets the standard for registration. This registration evaluation includes determining whether the composition of the pesticide warrants the proposed claims for it, the pesticide's labeling complies with all applicable requirements (e.g., is not false or misleading), and the pesticide will perform its intended function without unreasonable adverse effects on the environment. See FIFRA sec. 3(c)(5).

• Are pesticide manufacturers exempt from the Occupational Safety and Health Administration's (OSHA) requirement to provide a Material Safety Data Sheet (MSDS) with their product? (LC09-0249; 5.27.09)

  The hazard communications requirements of OSHA found at 29 CFR 1910.1200 include requirements for labeling and the provision of an MSDS as specified in the regulation. 29 CFR 1910.1200(b)(5)(i) specifically excludes pesticides from OSHA’s labeling requirements but not the requirement to obtain or develop an MSDS as necessary under 29 CFR 1910.1200(g). See 29 CFR 1910.1200(g) or contact OSHA for specific details on when an MSDS is necessary.

  Nothing in the Federal Insecticide Fungicide and Rodenticide Act (FIFRA) or its implementing regulations exempts pesticide manufacturers from the hazard communications requirements of OSHA. EPA has described how MSDSs interplay with pesticide labeling in PR-Notice 92-4. More specifically, under FIFRA’s definition of labeling, an MSDS that accompanies a pesticide product is labeling subject to FIFRA’s misbranding provisions (see FIFRA §§ 2(q) and 12(a)(1)) and must not conflict with EPA-approved pesticide labeling.

• In addition to EPA's required label for a pesticide, can the manufacturer add additional information, especially regarding worker health and safety? (LC09-0248; 5.27.09)

  All labeling – all written, printed or graphic matter attached to, accompanying or referenced on a pesticide product – must be approved by EPA. If a manufacturer wishes to add additional worker health and safety information to labeling beyond that which is required by FIFRA, he must submit the information to EPA for approval. The additional information may not be false or misleading or detract from the information required by FIFRA and must be part of the draft labeling submitted as part of an application for a new registration or as an amendment to an existing registration. Only when EPA approves the labeling may the information appear on the label of the product.

• Does a pesticide need to have an expiration date stamped on the label or bottle even if it doesn't expire?  What are the regulations for this?  (LC09-0244; 3/25/09)

  Pesticides aren’t required to have labeled expiration dates unless it is determined that the formulation significantly changes chemical composition (40 CFR 156.10(g)(6)(i)).  A one-year storage stability study is one of the product chemistry data requirements that a pesticide product must satisfy in order to obtain a registration (40 CFR 158.310, Guideline No.830.6317 or 40 CFR 161.190, Guideline No. 63-17, as appropriate).  If the results of this study show that the product will not remain stable for a one-year period, then an expiration date may be required.  If an expiration date is required the following statement must be placed in a prominent position on the label:   ‘‘Not for sale or use after [date].’’

• Specifically in regards to use sites that are going to be eliminated through amendment to terminate a use or uses due to a Data Call-In (DCI) or other EPA mandate; do you have to wait until the label is formally amended at the EPA and stamped approved before you begin removing these use sites from your marketing label? (LC08-0207; 9/22/08)

  A registrant may distribute or sell a product under labeling bearing any subset of the approved directions for use, provided that in limiting the uses listed on the label, no changes would be necessary in the precautionary statements, use classification or packaging.  [40 CFR 152.130(b)]  If a registrant intends to amend its registration to terminate a use in response to a DCI, the use could be removed from the marketing label at any time in advance of the use termination amendment as long as the removal doesn't trigger any requirements to change precautionary statements, use classification or packaging.

• We received a recent inquiry regarding the "stickering-over" of an incorrectly printed EPA Reg. Number. What is US EPA's official guidance on such a request? (LC08-0172; 5/15/08)

  Stickering-over an incorrect EPA Reg. Number is permitted provided the stickering-over is carried out in a registered establishment and is reported as relabeling in the establishment’s end-of-year report.  See 40 CFR Part 167 for more information on registered establishments and reporting requirements for them.

• In PR 2000-5, EPA states that label advisory statements can only be added or changed by amendment.  It is silent on how to delete advisory statements.  A previous PR Notice, 95-2, states that advisory statements can be deleted by notification.  Is this still the case? (LC08-0175; 5/15/08)

  PR Notice 2000-5 states that label advisory statements can only be added or changed by amendment, but does not specifically mention deletion of advisory statements.  An earlier PR Notice, 95-2, states that adding, revising or deleting advisory statements may be accomplished by notification.  However, a later PR Notice, 98-10, modified PRN 95-2 by stating that any advisory statements required by EPA may not be deleted by notification.  With regard to deleting advisory statements the questioner is correct that the latest PR Notice, 2000-5, is silent on the issue and therefore we conclude that the earlier PR Notices 95-2 and 98-10 are both still applicable.  Registrants may continue deleting non-required advisory statements by notification.  However, PR Notice 98-10 is also still applicable in that advisory statements required by EPA (for example, a ground water advisory) may not be deleted by notification and therefore may only be deleted by amendment.

• If a facility is blending chemicals to make a fungicide cleaner; what labeling requirements pertain to the actual blending tanks and associated piping, if any? (LC08-0166; 5-15-08)

  EPA, under FIFRA and its associated regulations, does not generally regulate labeling of blending tanks and associated piping used in the production of a pesticide by a registrant.  Therefore, unless one of the tanks holds a registered pesticide no labeling would be necessary for the blending tanks and piping under FIFRA.  If one of the tanks holds a registered pesticide, the tank would have to bear the label of the product.  Labeling for the end product must be present when the end product is released for shipment.  The production facility and/or the blending tanks and related piping may be subject to other EPA regulations or other federal regulations such as those promulgated by OSHA.  Note that this answer addresses blending tanks in a manufacturing setting to produce a registered end-use pesticide and is not intended to address custom blenders or refilling establishments.  See the Aug. 16, 2006 Standards for Containers and Containment Final Rule (71 FR 47330) for more information on requirements for these activities. 

• May the claim "New" be used on a pesticide label? If so, how long after registration is granted may the claim "new" be used on the label? (LC08-0160, 3/12/08)

  The claim “new “may be used on a pesticide label.  The label review manual (LRM) provides guidance that the term may be used on labeling of a product of new composition for a period of 6 months following approval of the label.  The term “new” may not be a part of the product name as it would be false or misleading after some period of time.  See 40 CFR 156.10(b).

• Does FIFRA provide for States to delegate the responsibility for enforcing the requirements of FIFRA to town-, city-, or county-level units of government? (LC08-0153, 1/24/08)

  Section 26 of FIFRA designates a State as having primary enforcement responsibility for pesticide use violations when the State has met certain criteria including adopting and implementing adequate procedures for enforcement.  See FIFRA § 26(a).  Most states have entered into cooperative agreements with EPA and have EPA-approved plans for enforcement under section 26(b) of FIFRA.  Section 26 of FIFRA is silent on whether local government shall or may be involved in enforcement.   In some cases, the State Lead Agency may work with local levels of government to enforce the use of pesticides or may delegate enforcement authority to local agencies.  These State-by-State procedures will be based on the State Lead Agency’s state authority to delegate their responsibilities under FIFRA to local entities.

• Does EPA allow the use of "dermatologist-tested" or "hypo-allergenic" on pesticide products?   LC08-0142; 1/17/08

  We are concerned about the terms "dermatologist-tested" and "hypo-allergenic."   Such terms could be misleading in accordance with 40 CFR 156.10(a)(5).  "Dermatologist-tested" is likely misleading in that it implies that a medical doctor has conducted studies with human subjects and those studies showed use of the product is safe.  OPP would not allow such a statement unless it was properly qualified so that it is not misleading and adequately substantiated with data.  We currently do not require or have protocols dealing with dermatology studies so acceptance of such data would be on a case-by-case basis.   Similarly with respect to the term "hypo-allergenic," such a claim would have to be substantiated with data and appropriately qualified so that it does not misleadingly imply safety.  Currently, there are no data requirements to validate such a claim on a pesticide label.   Such claims whether on the label or labeling (collateral promotional items tied to the product) would be subject to 40 CFR 156.10.  Note that testing with human subjects must comply with the requirements of 40 CFR Part 26, Protection of Human Subjects.

• If no restrictions are mentioned in a product label, can it be assumed that there aren't any rotational or planting restrictions?  Or is there a standard default when no specifics are given? LC08-0151; 1/17/08

  If a pesticide is registered on an agricultural crop(s) and there are no restrictions on the product label concerning when rotational crops may be planted or any other planting restriction intervals, such as crop failure, then it would not be a violation of FIFRA to plant new crops at any time.

• What regulation or code specifically forbids the use on labeling of quantities of pesticide product that are greater than the packing contains? LC08-0137; 12/13/07

  There is no specific citation either in FIFRA or the 40 CFR that forbids the use on labeling of quantities of pesticide product that are greater than the package container. However, such practice may be misleading to the consumer and, therefore, could be subject to the false and misleading provisions found in 40 CFR 156.10(a)(5).  In addition, the Label Review Manual (LRM) chapter 11 advises against directions for use that call for use of more than the net contents of the product’s container. 

• How do I get a letter certifying that my pesticide product is registered in the United States? (LC07-0088)
  
  The agency often certifies that a product is registered under the Federal, Insecticide, Fungicide and Rodenticide Act and as such may be sold and marketed in the United States. A true and correct copy of the product label in question accompanies the certifying letter. It is used by registrants to show to requiring foreign countries that their product is registered in the United States. This certification is often referred to as a "Gold Seal" letter (it carries a gold seal embossed with the EPA logo). You may send a letter requesting a copy to the Product Manager for the registration in question. If you do not know the Product Manager you may send it to the registering division.

• Can the agency provide companies guidance on the appropriateness of printing older version marketing / container labels when newer versions have been approved by EPA.  Since the label approval process is significantly delayed in CA, companies typically will continue to print older version labels despite having more recent versions approved by EPA, to ensure the product can be moved into CA (i.e., If the newer label is not yet approved in CA, product bearing the newer label can't be distributed or sold in CA.  Companies don't or can't segment their inventory of product bearing 2 different labels .  Therefore, companies typically print older version labels until CA has approved the newer version.  At that point, they will print the newer version labels).  (LC07-0085)

  The general rule that the Agency uses in addressing use of previously approved labeling can be found in 40 CFR 152.130.  As to situations where the registrant initiates the amendment, 40 CFR 152.130(c) states:  “Normally, if the product labeling is amended on the initiative of the registrant, by submission of an application for amended registration, the registrant may distribute or sell under the previously approved labeling for a period of 18 months after approval of the revision, unless an order subsequently issued by the Agency under FIFRA sec. 6 or 13 provides otherwise….”.  While this section does not specifically address printing of product labels, one can factor that in when determining the 18 month date and anticipated approval by state agencies.

• Does EPA's web site have a page that shows each registered product and its version ID?  (LC06-0063)
  
  The only Web site operated by OPP which has labeling is the Pesticide Product Label System (PPLS).  This system is a collection of images of pesticide labels which have been approved by the Office of Pesticide Programs (OPP) under Section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  The collection contains the initially approved label for pesticide products registered under FIFRA as well as subsequent versions of labels which have changed via amendment or notification.  The label images are indexed by EPA registration number and the date on which the label was initially registered or amended. 

  In addition to the stamped approved labels this collection contains any associated correspondence about the terms of registration, specifying any changes which the registrant was required to make in the final printed label.  Because some label amendments address only portions of the label, you may have to review several labels for a single product to determine the complete terms of registration.

  Please note that the system does not capture every version of every label.

  The collection does not identify those products which have been subsequently canceled or transferred, but rather identifies each pesticide label as it appeared at the time that it was approved.

• Can a fungicide be applied to an ornamental species not listed on the label to control a target disease listed on the label? Can a fungicide be applied to a food crop species not listed on the label to control a target disease listed on the label? (LC06-0061)
  
  1) If the product label lists only specific ornamental species, then only those species are the labeled use sites (crops).  If however, a label should state:  "For use on ornamentals, such as [listing of several specific species].", then the product could be used on all ornamentals.
  

  2) Regarding food crops, we must consider established tolerances for the active ingredient pesticide.  A pesticide label will only list food crops for which a tolerance or an exemption from the requirement of a tolerance has been established.  Sometimes, if a crop grouping has an established tolerance or exemption from tolerance, the label might list the crop group, for example, "For use on stone fruits, such as cherries, nectarines, peaches and plums."  This would allow for the product's use on all crops in the stone fruit crop group for which a tolerance or exemption had been established.  Therefore, if the label does not list a crop group, then application of the pesticide product is limited to only those food crop species listed on the label.

• Are their any federal or state requirements that limit and/or ban the retail sale of fertilizers (with or without pesticides) if the bag or container is torn or ripped?  If so, does the restriction apply to bags or containers that have been taped or somehow repaired? I believe the states of Texas and North Carolina have a restriction based on weights and measures. (LC06-0030)
  
  

  Fertilizers by themselves do not fall under the Federal Insecticide, Rodenticide and Fungicide Act (FIFRA).  Fertilizers mixed with pesticides are subject to FIFRA. While torn or ripped bags are not covered per se in the act or regulations there are several parts of the Act that could be applicable depending on the circumstances.  FIFRA 2(q)(2)(C) define misbranded, in part, as "... through which the required information on the immediate container cannot be clearly read, ." So if part of the label is missing or if tape covers up the label or makes it illegible, it could be misbranded.  It could also be misbranded if the amount remaining in the bag is significantly different from what is listed on the label.  If foreign matter was introduced to the package, the pesticide could be adulterated and therefore it may be unlawful to sell or distribute the pesticide under FIFRA § 12(a)(1)(E).  In addition, FIFRA 12(a)(2) makes it unlawful for any person to detach, alter, deface or destroy in whole or in part, and labeling required under the Act.  Any repackaging would need to occur in an EPA-registered establishment according to 40 CFR Part 167.  For state-specific requirements, contact the applicable state agency.

• Can a product with an EPA registration number and an EPA establishment number be sold to any state? (LC06-0020)
  
  In general, an EPA registration is a national license to market a pesticide product, and thus, under federal law, may be marketed in any state. However, in most cases, states also require registration of pesticide products under state law as a condition of sale and use. Thus, marketing a pesticide usually requires a state registration in addition to the EPA registration. The agency responsible for pesticide regulation in each state is the best source of information on their current requirements. Links to these state agencies can be found on EPA's pesticide program website at www.epa.gov/pesticides.

• Can misspelled words (e.g. "ration" instead of "ratio") be corrected on a label after the label has been approved? Does EPA need to be notified? (LC06-0023)
  
  After a label has been approved, misspelled words may be corrected without notifying EPA. According to Pesticide Registration Notice 98-10 "Correcting typographical and printing errors in labeling as well as changes in grammar and/or phrasing that do not change how the product will be used (e.g., adding and/or changing prepositions) are permitted by non-notification, provided that the use directions, signal words or requirement for child-resistant packaging do not change and that the format is consistent with Agency labeling requirements. Any corrections which result in changes in use directions, use precautions or the ingredient statement must be submitted as a notification or an amendment as described in this PR Notice."

• On labeling for devices there are a variety of items in the marketplace with a wide range of latitude when it comes to label requirements under Part 156. My example deals with fly paper and glue boards. Does the glue need to be listed as an ingredient? If yes, does the fly ribbon/paper of the cardboard on the trap need to be listed? (LC06-0005)
  
  Flypaper and glue boards are typically considered devices. 40 CFR part 152.500 states that devices are not required to be registered under section 3 of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Devices are, however, subject to the misbranding provisions of section 2 (q)(1) of FIFRA. In addition, devices must bear the EPA Establishment Number of the establishment where they were produced. In the example you cited, the glue does not need to be listed as an ingredient.
  

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13. Multiple Products Packaged Together

• A pesticide is sold as 10 1-fl-oz bottles in a box. A do-it-yourself pest store is selling the individual 1-oz bottles which do not have the full label. If they copy the full label and sell it with the bottle is this a violation? (LC09-0285; 7/21/09)

  Unless the EPA registration allows and the registrant has authorized the do-it-yourself pest store to sell the bottles individually and to copy the label and provide it to the customer, the act of copying the label and providing it to the customer along with the individual bottle is considered production and sale of an unregistered pesticide. If the registrant authorizes the do-it-yourself pest store to open a box and sell individual bottles along with a copy of the full label and such sale is permitted under the registration, the do-it-yourself store would have to register as a producing establishment and file annual reports of their production. In addition, the individual bottles, if sold separately without the full labeling, are considered misbranded and it is a violation of section 12(a)(1)(F) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) to sell or distribute a misbranded pesticide.

• “Kits” that contain multiple products.  These kits often contain one or more FIFRA-regulated products, along with, in some cases, one or more non-FIFRA products.  Each product in the kit is separately packaged and labeled – just as it would be if sold separately.  The kit consists of an outer container, such as cardboard box, which houses the separately-packaged FIFRA and non-FIFRA products placed inside the outer container. (LC07-0106; 10/29/07)
  
  Question 1.  Does EPA want to review each kit label, even in cases where  the label simply reprints the EPA-approved label language for each individual FIFRA product in the kit? 
  
  If the approved label(s) is visible through the outer packaging (e.g. visible through shrink-wrap), or if the outer packaging is an exact replica of the approved label(s), EPA does not need to review the kit label.  If, however, the kit is sold under a separate name from its previously registered contents, the kit must be registered as a separate product and the kit label must be reviewed.  40 CFR 152.5 defines “pesticide product” as “a pesticide in the particular form (including composition, packaging, and labeling) in which the pesticide is, or is intended to be, distributed or sold.”  40 CFR 156.10(b)(2)(ii) requires pesticide products to have unique names.  Therefore if the kit is considered anything more than the combination of separately named products (i.e., when the kit is marketed with its own distinct name), the kit must be registered.
  
  Thus if the kit is being sold as a unique product requiring separate registration or the individual product labels are not visible from the outer container or the previously approved labels are not used on the outer container in their entirety without modification, EPA must review the labeling through the registration (in the case of a new product) or registration amendment process.  The Agency may allow, if appropriate, a subset of the approved label to appear on the outer container.  In all cases, the following items are required to be fully visible either through the outer packaging or on the outer container: 1. Product Name, 2. Registration Number, 3. Ingredient Statement, 4. Signal Word, 5. Keep out of reach of children statement, 6. Precautionary Statements, 7. The full directions for use or a referral statement to read the labels on the containers in the box for full directions for use, including mixing or sequential use of the products, 8. Name and address of producer or registrant, 9. Net weight, 10.If highly toxic, skull and crossbones, “poison,” and a statement of practical treatment in case of poisoning, 11. Use classification (e.g. Restricted use), 12.Establishment Registration
  
  Question 2.  If so, should the company submit the kit label to the team for each pesticide contained in the kit, so that the label can be included in the registration jacket for each pesticide in the kit? 
  
  If review is necessary and multiple pesticide products are contained within the kit, the outer container label must be reviewed by the particular team for each individual pesticide product contained inside.  To help coordinate this review, it would be helpful to include a cover letter identifying the teams that will be reviewing the outer container label.>
  
  Question 3.  Please advise as to the appropriate method for submission.  For example, should the submission be made by means of notification or registration amendment?  Also, how should the submission be marked, so as to provide the reviewer a specific reference (e.g., regulation or PR Notice) for the submission.
  
  If label review is necessary, the amended label must be submitted as a registration amendment.  If no label review is necessary because approved labeling is visible either through the outer packaging or reprinted in total and the packaging changes meet the criteria found in PR 98-10 II.E., the change can be made through notification.
  
  Question 4.   As noted above, in some instances the kit will contain one or more FIFRA-products and one or more non-FIFRA products.  Does EPA also want to review the label for such “mixed” product kits?
  
  EPA has the responsibility to ensure that pesticide labeling – written, printed, or graphic matter accompanying the pesticide at any time – is not false or misleading before it is approved.  See FIFRA §§ 3(c)(3)(5), 2(p)(2)(A).  To that end, EPA will review labels for kits that contain both FIFRA and non-FIFRA products.  Where non-FIFRA labeling is printed on the outer container, the labeling must be reviewed because the non-FIFRA labeling would not have been previously approved by EPA.  EPA will review the pesticide portion of the label and relevant parts of the non-pesticide label (for instance, use of language that may interfere with the proper use of the pesticide).  The non-pesticide component will not be stamped approved by EPA.
  

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14. NAFTA Labeling

• We have the same source of a technical grade product registered in both the US and Canada.  The product is used to manufacture products in both Canada and the US.  May the package (a large bag) have both the US and the Canadian label on it, the accepted US on one side of the bag, and the accepted Canadian label on the other?  Would the Canadian label be considered "collateral labeling" and require EPA acceptance first?   (LC08-0147, 1/31/08)

  Generally, a pesticide package may not have both a U.S. and Canadian label on it because conflicting requirements between the two countries lead to conflicting labels which may mislead users.  Section 2(p)(1) of FIFRA defines “label” as “the written, printed, or graphic matter on, or attached to, the pesticide or device or any of its containers or wrappers.”  This definition encompasses all the written matter on a product and thus in the example described above, the Canadian label could not be distinguished from the U.S. label.  Because the Canadian label would be part of the product’s U.S. label, it must be reviewed and approved by EPA and must meet all U.S. labeling requirements including a careful review of how the two formerly separate labels might conflict.  In the case of NAFTA labels, there is a single NAFTA label which has been approved in both countries.  EPA encourages registrants to develop a NAFTA label for products that are sold or distributed in both the U.S. and Canada because the format of NAFTA labels provides solutions for dealing with potentially conflicting labeling requirements.  EPA also encourages registrants in this situation to consult with Canada’s Pest Management Regulatory Agency in addition to EPA.  For more information on NAFTA labels see http://www.epa.gov/oppfead1/international/naftatwg/labels/implem-labels.htm. 

15. Notifications

• Can insecticide or fungicide groups based on IRAC (Insecticide Resistance Action Committee) or FRAC (Fungicide Resistance Action Committee) classifications be added to a label via notification or does the label need to be updated via the amendment process? (LC09-0279; 8.13.09)

  IRAC and FRAC classifications refer to mode or target site of action groupings used in pesticide resistance management advisory statements. See PR Notice 2001-5 for more information. While pesticide resistance management statements are generally not required at this time, the Agency considers pesticide resistance management important. EPA encourages registrants to include both the resistance management statements and the mode/target site of action classification on product labels whenever submitting new or revised labeling to the Agency. In order to make it easy for registrants, the Agency allows the addition of resistance management statements and the mode/target site of action classification to be added to product labels by notification provided that registrant use either the wording provided in PR Notice 2001-5 or registrants use similar wording based on the attributes described in section VI of PR Notice 2001-5.

• Following up on LC06-0059, can a registrant add the phrase "Produced for" to their label without notifying EPA (as a non-notification - per PRN 98-10)? (LC08-0194)

  PR Notice 98-10 section IV.D, changes in name and address, indicates that non-notification would be appropriate for changes in the name and address of a registrant provided these comply with other regulatory requirements. As described in 40 CFR 156.10(c), use of qualifiers such as "produced for" are considered as part of the name and address element of a label.  Use of the qualifier “Produced for” in connection with the name and address can be done via non-notification.

• PR Notice 98-10 indicates that a registrant would be able to add state required analysis of fertilizer components.  We have recently been told by multiple registrants of dual (pesticide/fertilizer) products that EPA is not accepting notifications for these items.    Could you please indicate which PR Notice supersedes PR Notice 98-10 in this instance.  (LC07-0091)

  In accordance with section IV. C., "Revision, Addition or Deletion of Non-FIFRA Related Label Elements" of PRN 98-10, state-required analysis of the fertilizer component of a pesticide product can be added to a label without amendment or notification.  Although PR Notice 2000-5 does supersede sections of PR Notice 98-10, it does not supersede section IV.,C., pertaining to your question and therefore 98-10 reflects the most current guidance.

• Can language required by states be added via notifications? Does PR Notice 20-5 (Guidance for Mandatory and Advisory Labeling Statements) supersede PR Notice 98-10 (Notifications, Non- Notifications and Minor Formulation Amendments)? If an amendment is necessary, what is the typical turn around time for review of the amended label? (LC06-0013)
  
  Under FIFRA section 24(b), states cannot require labeling different from the federally-approved label. However, states can regulate sale and use in their state. Registrants may choose to amend their label to conform to state restrictions. These amendments would have to be reviewed by the agency. The amendment could fall under various time line categories, although most would fall within the fast-track category which has a 90-day turnaround.
  
  PR Notice 2000-5 does not supersede PR notice 98-10 in total. PR notice 2000-5 does affect one portion of PR 98-10: registrants may no longer add or change advisory labeling statements by Notification.
  

16. Packaging

• A registrant holds a registration on a place-pack style product, a product that contains multiple individual use items that are not intended for individual sale and are packaged into various larger offerings. Must the individual place-pack items bear the identical language to the outer container or is it acceptable to use a "shortened" version? If a retailer were to then attempt to sell the place-pack items individually, who would be held responsible? Would it be acceptable for a supplemental distributor to use the full label text on the individual place-pack items to protect against liability in the event a retailer split them up (even though the Basic is using the shortened version on their individual items)? (LC08-0208; 2.26.09)
  
  Individual items in a place-pack-style product may bear the full label or an abbreviated label. If the individual items bear a full label, they may be sold individually provided the amount contained in the place-pack is sufficient to control the pest for which it is intended. If the individual items bear an abbreviated label, they must refer to further directions on the outer container and bear a statement prohibiting individual sale. Sale of individual place-packs with abbreviated labeling is a violation of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) because they would not contain all required label language and therefore would be misbranded. See FIFRA secs. 2(q) and 12(a)(1)(E). If the basic registrant markets individual place-packs of a product with both full and abbreviated labels, the sub-registrant may market his place-pack products with either label. With the basic registrant’s permission, a supplemental distributor may put the full label on individual place-packs even when the basic registrant labels their individual place-pack products with an abbreviated label only. If a retailer sells individual place-pack items that bear a partial label he would be in violation of section 12(a)(1)(E) of FIFRA for selling or distributing a misbranded pesticide. Sale of individual, fully labeled place-pack items in units that are not sufficient to control the pests by either a retailer or a supplemental registrant could be a violation of FIFRA sec. 12(a)(1)(E) if the label doesn't sufficiently indicate that the individual place-pack item will not control a pest on its own.
  
  
• At a bulk terminal where a blank net contents and blank EPA Est. No. are printed onto a laminated label, would it be acceptable to place stickers with appropriate information beneath the blank portions of the preprinted label? The lamination makes it difficult for terminals to write in the information with permanent marker and it often fades once in the field. (LC08-0233; 1.28.2009)
  
  It would be acceptable to place stickers with the appropriate net contents and establishment number on the label, provided the stickers, like the label itself, are securely attached to the label and can reasonably be expected to remain affixed during the foreseeable conditions and period of use. See 40 CFR part 156.10(a)(4). Such stickering must occur at a registered establishment and be recorded per the requirements of 40 CFR Part 167.
  
  
• Is Draft PR Notice 2002-X in effect?  Section IV. B. 2 of Chapter 12 of the Label Review Manual seems to be in conflict with PR 2002-X, regarding use of superlative terms in product brand names.  Can a term like, "Super" or "Ultra" be used in a product brand name without qualifying it with the term "Brand"?; are the other disclaimers in PR 2002-X required at this time? (LC07-0124; 11/1/07)
  
  PR Notice 2002-X is only a draft PR Notice, and is not in effect at this time.  Section 12(a)(1)(e) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) makes unlawful the sale or distribution of any pesticide which is misbranded.  "Misbranded" is defined, in part, in FIFRA 2(q)(1)(A) as bearing "any statement ... which is false or misleading in any particular."  You should rely on the Agency regulations concerning false or misleading claims [40 CFR 156.10(a)(5) and 40 CFR 156.10(b)(2)].  In particular, 40 CFR 156.10(a)(5)(iv) lists "a false or misleading comparison with other pesticides or devices" as an example of a claim that may constitute misbranding.  Additional guidance on this issue is limited to the Label Review Manual.   The descriptors "Super" or "Ultra" may be found to be misleading on a case-by-case basis, if EPA determines that these terms in context imply unwarranted claims of heightened efficacy.  We suggest that you speak to the Product Manager assigned to your pesticide to discuss whether these terms are acceptable for your product.

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17. Pesticide Exemption(FIFRA 25B)

• Are there limitations to the claims that can be made for minimum risk pesticides as defined by 40 CFR 152.25(f)?  For instance, can a minimum risk pesticide bear both antimicrobial and insect repellant claims? (LC08-0149, 1/31/08)

  To qualify as a minimum risk pesticide under 40 CFR 152.25(f) (and be exempt from pesticide registration), a product must meet certain conditions.  These conditions fall into two categories, composition and labeling.  Specific to labeling claims, a minimum risk pesticide “must not bear claims either to control or mitigate microorganisms that pose a threat to human health, including but not limited to disease transmitting bacteria or viruses, or claims to control insects or rodents carrying specific diseases, including, but not limited to ticks that carry Lyme disease.”  40 CFR 152.25(f)(3)(ii).  In addition, the product may not include “any false and misleading labeling statements, including those listed in 40 CFR 156.10(a)(5)(i) through (viii).”  40 CFR 152.25(f)(3)(iii).

  With regard to the example posed above, antimicrobial and insect-repellency claims can appear together so long as they are not false or misleading.   It is important to note that the term “antibacterial” is considered to be an impermissible public health claim, whereas the term “antimicrobial” is not.  With regard to an insect-repellency claim, a minimum risk pesticide label might claim “controls mosquitoes” (if the product does in fact control mosquitoes), but not  “controls mosquitoes that can transmit malaria.”  If EPA were to test the efficacy of such a product and find that it does not control mosquitoes, the product would bear a false claim and therefore would not qualify for the 152.25(f) exemption, and would be deemed an unregistered pesticide.

  See also PR Notice 2000-6 for more information on minimum-risk pesticides.

• For pesticides exempt from registration under section 25(b) of FIFRA, the labeling regulations at 40 CFR Part 152.25 (f)(3) require listing each active ingredient by name and percentage by weight, and all other (inert) ingredients must be listed by name. Pesticide Registration Notice 2000-6 repeats this information. However, one state is requiring listing of the other (inert) ingredients with percentage by weight also, and to have a have a total line of 100% as required in Section 156 on labeling of EPA registered pesticides. Since these products are exempt from EPA regulation, can the state impose such a requirement? No other state is requesting that additional information for section 25(b) exempted products. (LC06-0026)
  
  Products that are exempt from Federal regulation under FIFRA Section 25(b) are still subject to State regulation, and many States continue to register these products. In certain States, selling a product may require meeting State labeling and testing requirements.
  
  As stated in PR Notice 2000-6 "Producers of pesticides must meet any applicable state registration or other regulatory requirements. Each state has its own statutes and regulations concerning pesticide registration and regulation, and the states are not required to permit the sale of an exempted product simply because it meets the 40 CFR 152.25 conditions for minimum risk exemption.

18. Pictures and Logos

• We have recently been awarded OMRI (Organic Material Review Institute) certification on two of our products and are wondering how to add this to our labels.  Is the OMRI logo permissible and is it a notification or amendment? LC08-0148, 1/17/08

  According to the OMRI website, OMRI "is a national nonprofit organization that determines which input products are allowed for use in organic production and processing" (http://www.omri.org/OMRI_who.html).  Submission of products to OMRI for certification is voluntary.  Addition of logos such as the OMRI logo to pesticide labeling must be submitted to OPP as amendments.   Use of the OMRI logo is considered an organic claim -- See the USDA's National Organic Program website for more information on organic production (http://www.ams.usda.gov/nop/indexIE.htm).  Organic claims are reviewed to determine whether they might be false or misleading.  OPP review of an organic claim may go beyond OMRI review as the Agency has access to formulation information and manufacturing information that OMRI often lacks.  For additional information on organic claims, see PR-Notice 2003-1 and the Label Review Manual, Chapter 12.IV. 

• Can a corporate logo "The Gold Standard for Performance" be used on labels in conjunction with a picture logo?  Can the disclosure of ingredients (active and inerts) be portrayed in Microsoft table format?  (LC08-0145)

  The Agency has generally considered slogans/logos such as “The Gold Standard for Performance” to be heightened efficacy claims and therefore potentially false and misleading statements under 40 CFR 156.10(a)(5).  The term "the Gold Standard" is not a new term or slogan but it is one that is widely recognized and intended to imply indirectly or state directly attainment of the highest or ultimate quality and/or a peerless product or level of performance.  The statement at the least implies the product is better than others and that any other product registered for the same or similar use(s) would not be as efficacious as the product bearing the slogan/logo.  Without sufficient supporting documentation showing the slogan/logo is neither 1) false (e.g. documentation demonstrating that the product meets criteria of some defined standard that the Agency has independently found not to be misleading) nor 2)  misleading (e.g. evidence showing consumers  would not be misled by the slogan/logo), the Agency will not accept use of such slogans/logos on labels or labeling.

  With respect to ingredient disclosure, formatting requirements are found at 40 CFR 156.10 (g) (1) and (2). The terms (active and inert ingredients) must be of the same type size, be aligned to the same margin and be equally prominent.  The ingredient statement must run parallel to other text on the panel on which it appears and be clearly distinguishable from and must not be placed in the body of other text.  As long as the Microsoft table format meets these requirements it would be permissible.

• Can an approved symbol (e.g. Good Housekeeping, DOT Hazard, Green Seal, etc.) be added to a registered pesticide product label without prior approval by the Office of Pesticide Programs (OPP)?  If not, what is the process and/or procedure for getting approval?  If prior approval is not needed, must a registrant notify EPA of the added symbol? (LC06-0057)
  
  The Agency approves symbols such as the logos listed above on a case-by-case basis.  Under 40 CFR 152.46, EPA may identify through a public process those changes that may be made to labels without obtaining prior approval from EPA.  Consistent with that regulation, in PR Notice 98-10, EPA announced that symbols required by other Federal agencies may be added to a pesticide label without notification to EPA.  At the current time, logos and symbols such as those listed in the question above, must be approved by EPA prior to placement on a pesticide label.  The approval process is initiated with an application for amended registration and/or registration.  During the approval process, the Agency will consider, among other things, whether the logo or symbol is false or misleading (see 40 CFR 156.10(a)(5)).  The Agency encourages registrants and applicants to meet with OPP to discuss symbols before submitting an application for amendment.  
  
  
• Is it acceptable to include pictures of adult people on labels for turf products? I found in the Label Review Manual that children are not allowed. However the manual is not clear if adults are allowed on the label. It basically discusses if the picture is of someone applying the product, then they need to have the proper PPE. Can we show an adult, who is not applying the product, but show the turf as part of a lifestyle through graphics such as an adult riding a bike on a sidewalk along the front yard or have them on the yard, reading, playing a game, etc. (LC06-0049)
  
  

  Pictures of adults may be used on a label as long as the photos are not used in such a manner as to be misleading or otherwise inconsistent with FIFRA or its implementing regulations.  Depending on how the picture or image is used, it could imply that the product could be used on a site or in some way for which it is not labeled.  Depending on the way pictures are presented, they can mislead the potential buyer into thinking one way, while the labeling text is saying something else.  The picture or image cannot be in conflict with any label text.

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19. Repacked Products

• May a supplemental distributor take a product out of the original container and repackage it into smaller containers? (LC08-0214; 1.28.2009)
  
  A supplemental distributor may take the product out of the original package and repackage it into smaller containers only if it is acting under the authority of the registrant to conduct such repackaging and only if the product as repackaged is consistent with the terms of the registration and EPA labeling regulations. Any repackaging must be completed in a registered establishment, as provided in 40 CFR part 167.
  
  
• I have a registered product with approved labels on the product bottle, and on the outside of the shipping container. If I take one bottle out of the case and ship it via a small package carrier, do I have to place the approved EPA label on the outside shipping carton? (LC08-0228; 1.28.09)
  
  You are not required to place a product label on a shipping container unless the product is customarily sold at a retail establishment in the shipping container. See 40 CFR part 156.10(a)(4).
  
  
• I have a registered product that is a 100% repack of another registered pesticide product.   Can I change the labeling of my product in accordance with PR Notice on notifications (PR Notice 98-10) even though the product label of the pesticide I am repackaging does not make this change?  Can I drop uses from the label or make it more restrictive than the label of the pesticide I am repackaging?  (LC08-0164; 5/15/08)
  
  You may make certain changes to the 100% repack's label in accordance with PR Notice 98-10.  While some changes to formulations are allowed through notification by PR Notice 98-10, you may not make any changes to your formulation for a 100% repack registration through notification.   For example, any changes under PR Notice 98-10 Section III on Product Chemistry would be unacceptable (e.g. change in source of ingredient).  In fact, if any change was made to the formulation, whether by notification or amendment, the registration would no longer be a 100% re-pack, which may affect use of the formulator's exemption found in 40 CFR 152.85.  These changes would require citation or submission of data and may require EPA review of such data.
  100% repack products may be registered for all or a subset of uses that the repackaged product is registered for.  The proposed addition of uses not found on the source product label is generally not permitted.
  Applicants may propose other changes in labeling but should be advised that label changes could give rise to a determination that the product is not eligible for the formulators exemption or "me-too" treatment under section 3(c)(7)(A) and 3(c)(3)(B) of FIFRA and  that data must be submitted or cited to support such changes.  As for dropping uses or adding restrictions to the label of a  registered repack, 40 CFR 152.130(b) allows distribution or sale of a product with "labeling bearing any subset of approved uses provided that in limiting the uses listed on the label, no change would be necessary in precautionary statements, use classification, or packaging of the product."  Therefore a 100% repack label could be marketed with all or some of the registered uses so long as limiting the use would not require a change in precautionary statements, use classification, or packaging of the product.  However, if a registrant actually seeks to delete a use from the registration (rather than simply market a subset of approved uses), the product label must be amended through traditional label amendment procedures (except when uses are being deleted in response to a data call-in, See PR-N 98-10 II.F) and in all such cases the voluntary cancellation procedure found in FIFRA 6(f) must be used to delete the use from the registration.  Adding restrictions to a label would necessitate changes in the directions for use on the label and such changes cannot be made through notification per PR Notice 98-10 but must be submitted as an amendment.

20. Service Containers

• A pool service company would like to purchase bleach in bulk (> 55 gallons), and place the bleach in smaller container for their own use in the servicing of swimming pools. As the smaller containers are NOT for resale, would they be required to have a copy of the pesticide label on the container, or just a label sufficient to meet OSHA requirements? (LC08-0168; 5/15/08)

  The Agency does not regulate service containers when they are used by applicators to provide a service of controlling pests without leaving any unapplied pesticide with their customers, and therefore does not require labeling of the service container (FIFRA section 2(gg).  EPA recommends that the user identify the material in the container in the event of an accident or spill.  The applicator is also responsible for meeting any other labeling requirements that may be required by other statutes.  If the applicator leaves a service container with a customer for the customer to apply at a later date the applicator must register the pesticide left behind and the service container must bear full labeling.  Please note that the applicator may only use registered sources of bleach in the servicing of swimming pools.

• Should the percentage of active ingredient listed be adjusted to reflect the diluted product? If not, could you provide some information as to why the concentrated product ingredient listing should be reflected on the label of the secondary container?

  A secondary container is a container used by an applicator to transport and store use dilutions of a pesticide for eventual use by the applicator. The percentage of active ingredient listed on the secondary container may be the same as that declared on the pesticide product, or if known, the percentage of active ingredient in the end-use dilution. Listing the percentage of active ingredient as reflected on the product label and indicating the product has been diluted as directed relieves the user from having to calculate the percentage of active in the dilute formulation. Such a calculation can be difficult for the average user when the directions for use call for a ratio of product to diluent, i.e., 1 part product to 64 parts diluent or 5 ounces of product to 128 ounces of water, and does not list the percentage of active ingredient in the finished dilution. Please keep in mind that the secondary container is strictly for the use of the applicator and may not be sold or distributed.

21. Subject to FIFRA

• What characteristics must materials/ingredients/product have in order for companies to not have to register the products with EPA in terms of pesticides and disinfectants? LC09-0290; 11/4/09

  A pesticide is defined as a substance or mixture of substances intended to destroy, prevent, repel, or mitigate a pest (FIFRA 2(u), 40 CFR 152.3). A product that makes a pesticidal claim must either be registered or exempt from registration. Certain categories of products have been determined not to be pesticides because they are not deemed to be used for a pesticidal effect and therefore need not be registered unless they contain a pesticidal claim. These categories, found in 40 CFR 152.10, are: 1) Deodorizers, bleaches, and cleaning agents; 2) Products not containing toxicants, intended only to attract pests for survey or detection purposes, and labeled accordingly; and 3) products that are intended to exclude pests only by providing a physical barrier against pest access, and which contain no toxicants, such as certain pruning paints to trees.

  Further 40 CFR 152.20 describes certain pesticides or classes of pesticide that are exempt from any FIFRA requirements because EPA has deemed them to be adequately regulated by another Federal agency. These categories include certain biological control agents and non-liquid chemical sterilants.

  In addition, there are a number of exemption provisions described in 40 CFR 152.25 that allow products to carry limited pesticidal claims without requiring registration, when such products are intended for use, and used, only in the manner specified:

  1. 152.25(a) allows an article or substance to make a pesticide claim if the article is treated with an EPA registered product that is registered for such use and the claim is limited to protection of the article,
  2. 152.25(b) exempts pheromones and identical or substantially similar compounds from registration if they are the sole active ingredient in a pheromone trap and they labeled for use only in pheromone traps,
  3. 152.25(c) exempts embalming fluids and other products used to preserve animals or animal organs in mortuaries, laboratories, hospitals, museums and institutions of learning.  Also exempt are products used to preserve the integrity of urine, blood, milk or other body fluids for purposes of laboratory analysis,
  4. 152.25(d) exempts food products that contain no active ingredient that are used to attract pests,
  5. 152.25(e) exempts natural cedar when it meet all of the criteria specified in that section are met,
  6. 152.25(f) exempts products containing certain minimum risk active ingredients listed in this section provided all of the criteria of the section are met.

  If a product makes a pesticidal claim and does not fit into one of the categories described above, then the product must be registered.

• What is the EPA's position on a farmer buying Formaldehyde from a dealer for the use of treating dairy cattle hooves? Is an EPA product registration required? How should this product application be treated as an antimicrobial, pesticide, or cleaner (disinfectant) through EPA? (LC09-0246; 5.27.09)

  Formaldehyde used to treat the hooves of dairy cattle for control of microorganisms is not considered a pesticide and does not need an EPA registration. FIFRA defines "pest" to exclude "viruses, bacteria, or other micro-organisms on or in living man or other living animals." FIFRA sec. 2(t). Only substances or mixtures intended for preventing, destroying repelling, or mitigating “pests” as defined by FIFRA or intended for use as a plant regulator, defoliant or desiccant are regulated as pesticides by EPA. Thus, products for use against microorganisms intended for use on or in living animals are not subject to EPA regulation. They instead are within the jurisdiction of FDA. For information on the FDA requirements regarding the use of formaldehyde on animals contact The Center for Veterinary Medicine (CVM) which regulates the manufacture and distribution of food additives and drugs that will be given to animals (http://www.fda.gov/cvm/).

• What are the regulations, PR notices, guidance documents related to glue traps used for rats and mice? (LC09-0245; 3/25/09)

  FIFRA section 2(h) defines "device" as any instrument or contrivance ... which is intended for trapping, destroying, repelling, or mitigating any pest or any other form of plant of animal life..." with some exceptions.  In general, if an article uses physical or mechanical means to trap, destroy, repel, or mitigate any plant or animal life declared to be a pest in 40 CFR 152.5, EPA considers it to be a device, and is not subject to registration under FIFRA section 3.  See also 40 CFR 152.500.  However, certain devices, while not required to be registered under FIFRA Section 3, are subject to the labeling requirements of FIFRA Section 2(q)(1) and 40 CFR Part 156.  On November 19, 1976, EPA issued a policy statement in the Federal Register (41 FR 51065) providing guidance and clarification on pest control devices and declared some devices to be of a character unnecessary to be subject to FIFRA.  According to that FR Notice "devices which operate to entrap vertebrate animals" are not subject to FIFRA.  However, based on January 30, 1980 decision by EPA's Pesticide and Toxic Substances, Enforcement Division (currently the Office of Enforcement and Compliance), EPA clarified that when it excluded devices that "entrap" vertebrate animals from regulation under FIFRA, it intended the exclusion to apply only to mechanical devices such as mouse traps and did not intend to exclude glue boards, which are analogous to fly paper and fly ribbons. These devices were both specifically identified in the 1976 Notice as being subject to FIFRA's requirements for devices. 

• Are military products exempt from Federal and State requirements such as antimicrobials? (LC09-0238; 2.26.09)
  
  Military products that bear any pesticide claim are not exempt from the requirements of FIFRA. You will need to check with each individual state regarding how military products are regulated within that state.
  
  
• Are products labeled as anti-bacterial adult toy cleansers which fight bacteria with triclosan subject to EPA jurisdiction as a pesticide/antibacterial product? (LC08-0173)
  
  “Pesticide” is defined in part as “any substance or mixture of substances intended for preventing, destroying, repelling, or mitigatingany pest.”  FIFRA § 2(u)(1).  Microorganisms (except for viruses, bacteria, or other microorganisms on or in living man or other living animals) are pests as defined by FIFRA sec. 2(t).  Products labeled as anti-bacterial adult toy cleansers which fight bacteria with triclosan are considered to be pesticide products because they are mitigating a pest and thus subject to EPA jurisdiction under FIFRA. The term “anti-bacterial” is also considered to be a public health claim which would require efficacy data be submitted with any application for registration.  These types of products are registered by the Antimicrobials Division.

22. Superlative Terms

• Is Draft PR Notice 2002-X in effect?  Section IV. B. 2 of Chapter 12 of the Label Review Manual seems to be in conflict with PR 2002-X, regarding use of superlative terms in product brand names.  Can a term like, "Super" or "Ultra" be used in a product brand name without qualifying it with the term "Brand"?; are the other disclaimers in PR 2002-X required at this time? (LC07-0124; 11/1/07)

  PR Notice 2002-X is only a draft PR Notice, and is not in effect at this time.  Section 12(a)(1)(e) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) makes unlawful the sale or distribution of any pesticide which is misbranded.  "Misbranded" is defined, in part, in FIFRA 2(q)(1)(A) as bearing "any statement ... which is false or misleading in any particular."  You should rely on the Agency regulations concerning false or misleading claims [40 CFR 156.10(a)(5) and 40 CFR 156.10(b)(2)].  In particular, 40 CFR 156.10(a)(5)(iv) lists "a false or misleading comparison with other pesticides or devices" as an example of a claim that may constitute misbranding.  Additional guidance on this issue is limited to the Label Review Manual.   The descriptors "Super" or "Ultra" may be found to be misleading on a case-by-case basis, if EPA determines that these terms in context imply unwarranted claims of heightened efficacy.  We suggest that you speak to the Product Manager assigned to your pesticide to discuss whether these terms are acceptable for your product.

23. Supplemental Labeling

• Does the Agency allow the use of the GHS corrosive symbol on supplemental distributor labeling without the symbol being on an approved stamped label? (LC09-0192; 8/28/08)
  
  40 CFR 152.132(d) requires that "the label of the distributor product is the same as that of the registered product" with certain listed exceptions such as the product name, registration number and establishment number.  Inclusion of additional symbols or graphics on a distributor label is not one of the exceptions.  Thus the basic registrant would have to add the GHS corrosive symbol to their label first before a distributor could use it.

• We have a current registration for a pesticide product. The label contains language which uses "may be used to treat..." in several places. In order to eliminate any ambiguity we wish to introduce directive language. Can this be effected by use of Supplemental Labeling? (LC08-0163; 5/15/08)

  Supplemental labeling in connection with section 3 of FIFRA is a term that the Agency uses to describe labeling which includes new approved uses and other information which have been accepted for a product since the last accepted Master label.    Supplemental labeling introducing directive language is inappropriate because the basic directions for use of the product are being modified.  This would lead to inconsistencies between the container label and the supplemental label, which are not allowed.  Such a change must be made by label amendment and must be incorporated into the standard labeling rather than through a supplemental label.  The Mandatory and Advisory Statements PR Notice (2000-5) provides guidance for improving the clarity of labeling statements.  The PR Notice states that adding or modifying mandatory or advisory labeling statements for currently registered products must be made by submitting an application for amended registration.  

  Voluntary changes such as proposed can be phased-in in various ways.  After the revised label is approved, the fastest way to get the new label in the marketplace would be to resticker product at registered establishments.  Alternatively, registrants generally have 18 months after the approval of revisions to distribute or sell product under the previously approved labeling.  See 40 CFR 152.130(c).  This means you would have 18 months before which the newly approved label would be required to be on products you sell or distribute.  Product with previously approved labeling may generally be sold by people other than the registrant until all such products are sold. 
  
  
• Please explain the conflict between the responses to LC08-0140 and LC07-0126 regarding the Agency’s position on requiring supplemental labeling to be stamped “approved.”(LC08-0165; 5-15-08)
  
  LC07-0126 deals with use of a supplemental label prior to that use being placed on a product label and put in distribution.  Question LC08-0140 discusses taking a use off of a label in production and placing it on a supplemental label.  In question LC07-0126 we assumed all appropriate labeling from the product label would be placed on the supplemental labeling and this labeling had been reviewed and found approved.   In reviewing question LC08-0140 we decided that because the use may be tied to the product label by many different restrictions (human precautions, environmental precautions, use etc) there is too much of a chance for conflicting information on the product label and supplemental label, therefore, the Agency needs to review and stamp the supplemental labeling.  This same thought process should apply to question LC07-0126.  Any supplemental labeling should be approved by the Agency.  We will be revising the answer to LC07-0126 to reflect and refer to LC08-0140.
  
  
• In a situation where a registrant voluntarily cancels a registration, the registrant generally has 18 months to continue to sell product in channels of trade. When a basic registrant terminates a supplemental registration, does the sub-registrant (the supplemental distributor) have the same 18-month period to sell product? LC08-0156; 3/20/08

  EPA interprets 40 CFR 152.130(c) to generally permit a supplemental distributor 18 months to sell and distribute existing stocks after the basic registrant terminates the supplemental registration.  In this context, the supplemental registrant's existing stocks are only those affected pesticide products that have been released for shipment as of the effective date of termination of the subject supplemental registration.  Sale or distribution of any quantities of the affected distributor product produced after the effective date of termination would be considered illegal under FIFRA.  It is important to note that while EPA regulations may permit such distribution or sale of existing stocks for 18 months following termination of the supplemental distribution, the contractual arrangement between the basic registrant and the supplemental distributor may contain terms that further limit or preclude sale and distribution by the supplemental distributor (although such contractual arrangements would be enforceable through the courts, and not by EPA).

• We are a supplemental distributor registrant for a product.  One of our customers would like to buy our subregistered product, but they would like to have their name and logo on the packaging.  Can we label the product with our customer's name, address and logo on the front panel, qualified by "Sold by"; and still put our name, address, Reg. No., and Est. No. on the back panel, qualified by "Distributed by"? (LC08-0131, 1/31/08)

  40 CFR 152.132(d) requires that the labeling of the distributor product be the same as that of the registered product with the following exceptions:

  (1) The product name of the distributor product may be different (but may not be misleading);
  (2) The name and address of the of the distributor may appear instead of that of the registrant;
  (3)The registration number of the registered product must be followed by a dash, followed by the distributor’s company number (obtainable from the Agency upon request);
  (4) The establishment number must be that of the final establishment at which the product was produced; and
  (5) Specific claims may be deleted, provided that no other changes are necessary.

  These exceptions do not allow for the supplemental distributor to put a customer’s information on the label.  However, the supplemental distributor could incorporate the customer’s name into the product name (e.g. X’s insecticide) so long as the new product name is not misleading and the registrant allows the subregistrant to make such a change under any applicable contracts between the registrant and subregistrant.

• Can a registrant pull new uses/directions for use, etc. from an EPA "accepted" master label in order to produce a supplemental label or must a supplemental label be approved by EPA in order for the registrant to produce a supplemental final product label?  LC08-0140, 1/10/08

  Supplemental labeling (not to be confused with supplemental distribution under 40 CFR 152.132) is a term used by the Agency to describe labeling which includes newly approved uses, or other changes such as reduced/increased pre harvest intervals which have been added since the last accepted Master label.  These are partial labels distributed with the product by the registrant or distributors.  Since these are partial labels, they must bear a statement referring the user to the product label for complete directions, precautions and a statement that the labeling must be in the possession of the user.  Both the product label and the supplemental labeling are required to safely and effectively apply the product for its supplemental use.  See the Label Review Manual (LRM), Chapter 3 paragraph IV. D. (http://www.epa.gov/oppfead1/labeling/lrm/chap-03.htm). 
  The supplemental labeling must be submitted and stamped “accepted” by the Agency.  The Agency requires that these labels bear the following information:
  Misuse statement: "It is a violation of Federal law to use this product in a manner inconsistent with its labeling."
  The labeling must be in possession of the user at the time of application.
  Read the label affixed to the container for [pesticide X] before applying.
  Use of [pesticide X] according to this labeling is subject to the use precautions and limitations imposed by the label affixed to the container for [pesticide X].
  Product Name
  EPA Registration Number
  Restricted Use Statement (if required)
  Normally, supplemental labeling will be incorporated into the affixed label at the next printing of the product label (final printed label) or within 18 months, whichever comes first.  However, there are circumstances when this might not be done, for example if the directions for use on the supplemental labeling are subject to continual, frequent change, e.g., California aerial application county restrictions can change every six months or so.  In that case, a supplemental label will likely be replaced with a new supplemental label before it must be incorporated into the affixed label.  Note that just like other labels, supplemental labels must be accepted prior to distribution.
  Because supplemental labels are intended to add to the existing label and not conflict with the existing label, taking a registered use off of an existing label to make it a supplemental label would not be acceptable.  If a registered use was "taken off" the existing label to be put on a supplemental label, it would still appear on the existing containers until the next printing and a supplemental label with the use would cause confusion.
  If a company wanted to segregate uses that are currently on an affixed label, it would be permissible for a company to take a use(s) from a master label and place it on segregated product label that would be marketed separately with the segregated use directions on the affixed label.  See 40 CFR 152.130(b).  This is often referred to as Sub or Split label (see LRM Chapter 3, paragraph IV).  That label would not be a “supplemental label” but a stand-alone product label under the existing registration and must comply with all applicable EPA label requirements.

• Must a subregistrant use the warranty statement that is on the Basic Registration label? The subregistrant wants to substitute its own warranty statement. LC08-136; 12/13/07

  40 CFR § 152.132(c) generally limits that changes that can be made between a registrant’s label and a supplemental distributor’s label to the name of the product, the name and address of the distributor, the registration and establishment numbers and a deletion of claims on the distributor product.  However, because warranty statements are not required by EPA to be on pesticide labels, the Agency will allow supplemental distributors to use their own warranty statements so long as such a change to the labeling is allowed by contract between the registrant and the distributor and the substitute warranty statement is not false or misleading.  See FIFRA Compliance Program Policy No. 3.2 (May 10, 1982).  Any revised warranty statement on a distributor's label cannot expand upon, either explicitly or implicitly, the uses allowed on the registrant's label and cannot conflict with the claims stated on the label.  For help in developing an acceptable warranty statement, see the guidance available at http://www.epa.gov/pesticides/regulating/labels/pdf/warranty.pdf (11 pp, 60K, About PDF)

• When EPA approves a label amendment to add a new use to an existing label, and the label version that EPA stamps as "Approved" is the complete Section 3 label (including the new use), the registrant will sometimes prepare a Supplemental Label to extend the new use to customers who might otherwise have access only to containers that are not labeled with the newly approved use.  What is EPA’s stance on this type of Supplemental Labeling?  Is the Supplemental label already considered to be “EPA approved” based on the fact that the wording is directly extracted from the EPA Stamped Label, or, must the Supplemental Label be separately “stamped” (or approved) by EPA? LC07-0126: 11-8-07

  First, as clarification, the term "supplemental label" as used by the questioner does not relate to supplemental distribution under 40 CFR 152.132.  A supplemental label, in the context used by the questioner, generally has been required to contain certain labeling elements including, at minimum:

  Misuse statement: "It is a violation of Federal law to use this product in a manner inconsistent with its labeling."
  Statements such as:
  “The labeling must be in possession of the user at the time of application.”
  “Read the label affixed to the container for [pesticide X] before applying.”
  “Use of [pesticide X] according to this labeling is subject to the use precautions and limitations imposed by the label affixed to the container for [pesticide X].”
  Product Name
  EPA Registration Number
  Restricted Use Statement (if applicable)

  Because it is important to assure that any necessary labeling elements are provided and that the supplemental labeling does not conflict with the container label, the Agency will review supplemental labeling and stamp approval. The supplemental labeling may then be used in connection with the registered product that is labeled with previously approved labeling.Please note that adding the supplemental labeling to an already produced product (whether by affixing the supplemental label to the container or by causing the label to accompany the product) is considered production and must be done in a registered establishment.  Handing out supplemental labeling at a dealership, unless it is a registered establishment, is not acceptable. The label on the container and the labeling that accompany the product are the labeling that must be followed; therefore, the approved supplemental label must accompany the product and be in the hands of the user at time of application. 

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24. Termiticides

• A Do-It-Yourself retail store offers for sale a general-use termiticide product with the statement “For sale to, use and storage only by individuals/firms licensed or registered by the state to apply termiticide and/or general pest-control products."  Is it "use inconsistent with the label” for a non-licensed home-owner to purchase and use the product?  (LC08-0186)

  It is not a Federal violation for an unlicensed individual to purchase a registered general-use product that bears the labeling referenced.  It is a violation of FIFRA 12(a)(2)(G) for an individual who is not licensed by the state to use a product that bears the labeling referenced.  In addition, it may be a violation of state law for an unlicensed individual to purchase products that include that labeling. 

  Note that for termiticide products, PR Notice 96-7 includes the preferred statement that should be used on termiticide labels:

  “For use by individuals/firms licensed or registered by the state to apply termiticide products. States may have more restrictive requirements regarding qualifications of persons using this product. Consult the structural pest control regulatory agency of your state prior to use of this product." 

• What is the difference between a guideline and requirement in regards to use directions of common restricted-use termiticides? I have seen conflicting reports on whether "Directions for Use" on the label are considered a requirement (which are not subject to interpretation) or whether they guidelines (which are subject to the interpretation.) (LC06-0006)
  
  A guideline (a, principle, or piece of advice) is neither mandatory nor enforceable but rather is included on the label for the user's guidance. A requirement (e.g. something required through a regulation or adjudication like the act of registering a pesticide) is both mandatory and enforceable. Directions for Use are required to be on all pesticide labels. Certain statements in the Directions for Use section may be advisory and others are mandatory. Requirements or mandatory statements are written in a directive manner. The following are examples of language used in the Directions for Use to alert the user to a mandatory duty: such as (1) "Do not use ...," (2) "Users must...," and (3) "Apply at a maximum rate of ." Other statements may appear in the Directions for Use in an advisory manner e.g., descriptive or nondirective terms, such as "should," "may" or "recommend." See PR Notice 2000-5 concerning advisory versus mandatory language (http://www.epa.gov/PR_Notices/pr2000-5.htm). It is important to note that if any requirement under the Directions for Use is not followed, the user is using the product in a manner inconsistent with its labeling and is in a violation of FIFRA. See FIFRA section 2(ee).
  
  
• Questions and Answers on EPA PR Notice 96-7(LC06-0025):

1. As used in EPA PR Notice 96-7 and appearing on termiticide labels, what is the meaning of "do not apply at a lower dosage and/or concentration than specified on this label for applications prior to the installation of the finished grade"? In particular, does this refer specifically to the concentration of termiticide in the spray mix and volume of spray mix applied per unit area?
   
   It refers to either. There is no reason for applying a lower concentration of termiticide active ingredient in the spray mix or a lower dosage than is specified by the label. Less volume of the end-use dilution may be applied as directed by the label. PR Notice 96-7 makes reference to soils that cannot accept the label prescribed volume of end-use dilution and includes language for labeling to address this condition. This language is found on the labels of all soil applied termiticide products.
   
   At the finished grade, soil movement and manipulation is completed on the site and the house is build. As you know, sub-slab treatments take place according to label instructions before the "interior slab" is poured but after all interior grading is completed. Exterior perimeter applications should take place after final grading of the soil outside the foundation to insure that treated soil, hence the barrier or treated zone, is not disturbed. However, EPA has not defined the term "finished grade" on the label.
   
   
2. Does this also require any particular extent of coverage of horizontal or vertical surfaces or is this addressed elsewhere in label instructions?
   
   Treatment should be made as directed by the label to provide both a horizontal and vertical barrier. The extent of coverage is usually dependent upon what will cover the soil where the treatment is made i.e., slab floor, carport, etc.
   
   
3. Do EPA regulations define partial treatment and full treatment as they relate to termiticide treatments?
   
   The regulations do not. PR Notice 96-7 describes a complete soil applied treatment as do the EPA approved soil applied termiticide labels. However, EPA approved a new type of full treatment for termiticide products in 2004. These products can be applied as a post-construction treatment known as an Exterior Perimeter/Localized Interior Treatment (EP/LIT) as directed by the label. These labels are very specific about how this treatment is to be made.
   
   Generally speaking, a spot treatment is approximately 20% of the area to be treated.
   
   
4. Has EPA approved labels for pre-construction termite treatments for soil barrier termiticides that have permissive language in regard to extent of horizontal or vertical treatment?
   
   We are not aware of "permissive language" being approved for soil applied barrier products. As far as we know, EPA has only approved the language consistent with PR Notice 96-7 for pre-construction treatment. Some labels provide even more detail than the PR Notice. Please also refer to our response to Question #2 above.

25. Water Soluble Packaging

• Where can I find a list of EPA-approved inks for Water Soluble Packaging (WSP)? (LC08-0206; 9/22/08)

  There is no specific list of approved inks for water soluble packaging (WSP).  For a listing of inert ingredients permitted for use in nonfood use pesticide products refer to the Agency web site http://www.epa.gov/opprd001/inerts/inert_nonfooduse.pdf.  For a listing of inert ingredients permitted for use in food use pesticide products refer to the tolerance exemptions listed in 40 CFR 180 beginning with  40 CFR 180.910 (available at     http://www.access.gpo.gov/nara/cfr/waisidx_07/40cfr180_07.html).

• PR Notice 94-8 on Water Soluble Packaging (WSP) at II.4 states "Labeling of an individual WSP unit is optional if the WSP is integrally sealed in an outer container that bears appropriate labeling." Would you please clarify if this applies when more than one (i.e., 2 - 4) WSP packets are placed in one sealed outer container that bears appropriate labeling. (LC07-0096)

  If the directions for use on the outer container require that all WSP units inside be used at the same time, labeling of the individual WSP units is optional.  If the units may be used separately, the minimum labeling on each unit should be in accordance with PR Notice 94-8 so that each unit would be labeled in the event it becomes separated from the outer container.  PR Notice 94-8 lists the following elements for labeling inner WSP units:  product name, statement of active ingredients, signal word, skull and cross bones if required, Keep out of reach of children statement, EPA registration number, restricted use statement if so classified and a referral statement to the main label.
  
  
  

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