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).

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.

Advertising Claims
- 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.
American Type Culture Collection (ATCC) Numbers

Many registrants list ATCC numbers in parentheses after a specific bacteria. If the ATCC number is present on the EPA stamped "accepted" label, must it also be present on the final marketplace label or may the registrant omit the ATCC numbers from their final product labeling? (LC08-0152; 2-21-08)
In the past, EPA requested that American Type Culture Collection (ATCC) numbers appear on the final printed labels of products. However, after further consideration, EPA determined that while the ATCC numbers are necessary for the Agency microbiology reviewers as identifiers for the microorganisms tested and listed on product labels, they may not have the same level of significance to the end-users of the products. Therefore, the Agency now allows a company to list ATCC numbers in one of the following locations:

            On the data matrix provided to the Agency
            On the master label (as optional text) with the listing of the organisms claimed, or
            As the final page of the master label (as optional text).

Thus, ATCC numbers do not have to appear on the final product labeling since the ATCC numbers may be placed on the label as optional text.

3. Antimicrobial Claims

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.
Does EPA consider the term "sanitary" (as in "leaves surfaces sanitary") to be a pesticidal 'Produced for Company X? (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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4. Base Label Contents

RE: Chapter 3 General Label Requirements II.B. Container Label Contents When
Booklets are Used: Many products are in small package sizes, i.e. gal, pt, qt, 250 ml and all of the text cannot fit on the base label (even with a front and back bottle label) Could you define EXACTLY what information is required to be on the base label. LC08-0130; 11/29/07
As described in Chapter 3.II of the Label Review Manual, the following must be on the label which is on or “securely attached” to the container.

Name and address of the producer, registrant, or person for whom produced

Restricted Use Statement (if required)

Product Name, Brand or Trademark

4    Ingredient Statement
5   Signal Word, including Skull & Crossbones, if either are required
6   "Keep Out Of Reach Of Children" (KOOROC)
7   Precautionary Statements, including Hazards to Humans & Domestic Animals and Environmental Hazards
8   EPA Registration Number and EPA Establishment Number
9   Either Directions for Use or a Referral Statement to Directions for Use in booklet, if any
     10 Net weight or measure of contents

Other parts of the label may be placed in a booklet or other “pull off” type labeling. This would include C2-.Directions for Use, which includes C3- Storage and Disposal, and C5-Worker Protection Labeling [see 40 CFR 156.206(b)(3) for information on placement and required referral statements], and C4- Warranty Statement .

5. 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.

6. 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 * * *."

7. Definitions/Interpretations

Is the February 6, 1991 policy decision from the Office of Compliance Monitoring's Policy and Grants Division regarding greenhouse application still current? This policy indicates "that a label must specify greenhouse in order for the product to be applied in a greenhouse". I thought EPA revised this policy, but I was told by another state that this is still EPA's current view. (LC08-0170; 5/15/08)

The Agency’s current position on greenhouse application is that in accordance with FIFRA section 2(ee) a label does not have to specify greenhouse as a site, provided the crop is on the label, in order to use the product in a greenhouse.
Labels with non-agricultural use requirements often have statements such as “Do not allow people or pets on treatment area during application. Do not enter treatment areas until sprays have dried…”

Regarding the second sentence of that statement, is it directed at all people or just workers that the applicator has control over? Is it the responsibility of the applicator to make sure that no one enters the treated area until sprays have dried, and if so, how can the applicator accomplish that when applying to roadside right-of –ways and other areas that they cannot realistically control? LC07-0123; 11/15/07

The label language cited (or similar labeling) appears on many labels with non-agricultural uses and must be read carefully in the context of the entire labeling of the product. There are many variations of the statements cited above and based on the wording of the statements they may have different meanings. On some labels the prohibitions against entry are specific to certain uses. On other labels the prohibitions are expressed in such a way that the prohibition applies to a broad array of uses.

The prohibition in the language cited above applies specifically to the applicator of the pesticide. The first sentence requires the applicator to keep people or pets from entering the treatment area during application. While the applicator may not be able to control the movement of people or pets into the area, the applicator can and must stop applying the pesticide if people or pets enter the area being treated. The second sentence prohibits the applicator from entering the treated area until sprays have dried. Neither sentence would require the applicator to have a continuing obligation to keep people or pets out of the treated area after application of the pesticide.
Would EPA regulate fertilizer and soil amendment products marketed by company “F” as pesticide products under the following conditions: contains a known synthetic plant growth regulator (e.g NAA and IBA), intends to market these products on food crops or, does not declare the synthetic plant growth regulator ingredients on the label. (LCO6-0074)
The Federal Insecticide Fungicide and Rodenticide Act, as amended, defines a pesticide in part as “1) any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pests, 2) any substance or mixture of substances intended or used as a plant regulator, defoliant, desiccant, and 3) any nitrogen stabilizer …” FIFRA § 2(u)(emphasis added).

Regulations established under FIFRA state, in part: “A substance is considered to be intended for a pesticidal purpose, and thus to be a pesticide requiring registration, if:
* * *
“b) The substance contains one or more active ingredients and has no significant commercial value as distributed or sold other than
(1) use for a pesticidal purpose (by itself or in combination with any other substance), (2) use for manufacture of a pesticide;” 40 CFR part 152.15 (emphasis added)

Under 40 CFR 152.15(b), products containing NAA and IBA may be pesticides even if no claims were made on the label.

Intent for a pesticidal purpose is considered on a case-by-case basis and the Agency may determine a product is a pesticide, and therefore requires a registration, regardless of the product’s label claims. If you are unsure whether your product is a pesticide, it would be prudent to contact the Office of Pesticide Programs.
What is the Agency's policy in the event a registrant or manufacturer wants to remove pesticidal claims from a product label in order to avoid the obligation to register the product?

The lack of pesticidal claims on a product does not necessarily mean the product does not need to be registered. The Federal Insecticide Fungicide and Rodenticide Act defines a pesticide in part as "1) any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pests, 2) any substance or mixture of substances intendedor used as a plant regulator, defoliant, desiccant, and 3) any nitrogen stabilizer ." FIFRA § 2(u)(emphasis added).

Regulations established under FIFRA state, in part: "A substance is considered to be intended for a pesticidal purpose, and thus to be a pesticide requiring registration, if:
* * *
"b) The substance contains one or more active ingredients and has no significant commercial value as distributed or sold other than
(1) use for a pesticidal purpose (by itself or in combination with any other substance),
(2) use for manufacture of a pesticide;" 40 CFR part 152.15 (emphasis added)

Intent for a pesticidal purpose is considered on a case-by-case basis and the Agency may determine a product is a pesticide, and therefore requires a registration, regardless of the product's label claims. If you are unsure whether your product is a pesticide, it would be prudent to contact the Office of Pesticide Programs.
What is the official EPA definition of an "orchard" in respect to the boundaries? Is it the outside drip line of the trees, or number of feet beyond the drip line, or another criterion? Some do not have fence lines and are part of a larger field. (LC06-0028)

EPA has not established an "official" definition of "orchards" as used on product labels. An orchard is considered a distinct use site. Generally, one would take a common sense approach to determining where a product labeled for use in an orchard might end. Normally, one would determine that the orchard would end at the outer edge of the drip line of the last row of trees.
What is the statutory or regulatory authority that the word "should" used on pesticide labels is non-mandatory language. (LC06-0032)
Neither the Federal Insecticide, Fungicide and Rodenticide Act ("FIFRA") nor its implementing regulations contain a definition of the term "should." The Office of Pesticide Programs (OPP) recognized the need for clarification of whether the term "should" on pesticide labels is considered mandatory or advisory and issued a Pesticide Registration Notice (PR notice) in 2000 (see PR notice 2000-5 at http://www.epa.gov/PR_Notices/pr2000-5.htm). The statutory basis for this PR notice is section 2(ee) of FIFRA, which defines the term "to use any registered pesticide in a manner inconsistent with its labeling" (i.e., misuse) as use of "...any registered pesticide in a manner not permitted by the labeling...." The following excerpt from PR notice 2000-5 explains OPP's interpretation of terms such as "should", "may," and "must" as used on pesticide labels.

PR notice 2000-5 states, in pertinent part:

Mandatory statements, which commonly use imperative verbs such as "must" or "shall," either require action or prohibit the user from taking certain action. Advisory statements generally provide information, either in support of the mandatory statements or about the product in general. To ensure that the intent of each labeling statement is clear, mandatory statements need to be clearly distinguishable from advisory statements.
Currently, labeling provisions are enforced by taking into consideration all of the information presented on the label and by reading advisory statements in the context of the entire label. Problems can arise when advisory statements are either vague or ambiguous in meaning, or are inconsistent with mandatory labeling statements. In the past, advisory statements have commonly used suggestive verbs such as "should," "may" or "recommend" to encourage the user to achieve the directed behavior, but often these statements can be unclear as to whether they are mandatory or advisory.
Advisory language using terms such as "should," "may" and "recommend" can create ambiguities as to the intent of the direction or precaution. Too often, common everyday speech using the word "should" creeps into mandatory label statements where the imperative tense is needed to communicate that certain action is required. Another problem is contradictory headings and statements. A set of mandatory directions preceded by an advisory heading such as "Use Recommendations" potentially conflicts with the nature of the intended action. Lastly, the use of words such as "should" in advisory language can mistakenly imply that an unaccepted use is permissible. For example, the direction "you should remove all food articles prior to use" on a product that is not registered for any food uses could be mistakenly read to suggest that it is not mandatory to remove all food from the area to be treated. Consequently, such a statement would not be acceptable.
The Agency seeks to improve mandatory and advisory labeling statements by providing guidance (see Appendix) on how they can best be written. Mandatory statements are generally written in imperative or directive terms (such as "shall," "must," "do this," "do not") so that a typical user will understand that these statements direct the user to take or avoid certain actions, and that failure to follow these instructions is a misuse of the product. Advisory statements are generally best written in descriptive or nondirective terms to support the mandatory statements or provide information. Suggestive terms such as "should," "may" or "recommend" may be confusing or ambiguous, or potentially conflict with mandatory labeling statements; thus, they are to be avoided. EPA realizes that the use of descriptive terms for advisory statements is not appropriate for every situation and that there are times where it may be necessary to use "should," "may," "recommend" or similar words.
What does a 7-day restriction mean? Is it 7 days from time treatment ended (7/24) or does the treatment day count as Day 1 and from then out to Day 7? (LC06-0014)

Traditionally the Agency considers the day of treatment to be Day 0. The 7-day restriction (pre-harvest interval) would start with Day 1 which is the day after the initial treatment with subsequent days to follow in order. The Agency has not required the exact time of treatment to be recorded but if someone were to appropriately document treatment ending at, for example 11:00 a.m. on Day 0, then Day 1 would end at 11:00 a.m. the next day and so forth.
What is the minimum labeling required on the outside shipping container that is used to transport several individually labeled containers to be sold/distributed separately? (LC06-0002)

Under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) there is no minimum labeling required for shipping containers unless the shipping container is the unit customarily sold to the end user, in which case full labeling is required. The Agency suggests that at a minimum, shipping containers bear enough information to identify the contents of the container in the event of an accident or spill; usually product name, active ingredient(s), EPA Registration Number, and any pertinent precautionary labeling. Other regulatory agencies, such as the Department of Transportation, may have requirements concerning the labeling of shipping containers generally, which may apply to the shipping of pesticide products.
If a label contains the statement, "For Industrial/Institutional/Commercial Use Only", does this prohibit its sale to consumers for household use? (LC06-0021)
The language "For Industrial/Institutional/Commercial Use Only" does not prohibit a product's sale to consumers for household use. All products are classified as General Use or Restricted Use as described in 40 CFR 152.160 . General Use products may be sold to any person without restriction. Products classified for Restricted Use may only be sold to and used by certified applicators or persons under their direct supervision and are therefore prohibited from sale to the general public. The Agency has in certain cases limited the use of products to certain groups of users without classifying the product for Restricted Use. Three examples where this occurs are use by veterinarians, mosquito control officials and persons licensed or certified by a state to apply termiticide products. In these cases, the users are individuals identifiable either by a state credential or by being employed by certain public agencies. Individuals who are not members of these groups may still purchase these products but they are prohibited from using such products. The Agency believes the language "For Industrial/Institutional/Commercial Use Only" is too vague to clearly identify a discrete set of users and therefore would not be an enforceable means of limiting sale or use.
Is the sentence "Use of this product where soils are permeable, particularly where the water table is shallow, may result in leaching to groundwater" advisory only? (EX1)
The statement is advisory and is intended for informational/advisory purposes. The expectation is that the user will read this section of the label, be made aware that this product can move into groundwater, and will carefully follow label directions when using the product to prevent groundwater contamination.
Does "unused product" refer to both opened and unopened packages? (EX2)
Yes. The phrase "unused product" should be interpreted as opened product containers as well as unopened containers.
What specifically is meant by the phrase "Do not apply to institutions in the immediate area when occupants are present"? (EX3)
Institutional use is defined in 40 Code of Federal Regulations 152.3 , to include hospitals, nursing homes, schools other than preschools and daycare centers, museums, libraries, sports facilities, and office buildings. The product can't be applied if one or more occupants are present in the immediate area where the product is to be applied.
What is the EPA's definition of "shallow ground water"? (EX4)
EPA has not established a standard depth to define shallow ground water. Hydrologic characteristics differ between regions of the country so shallow ground water is usually defined on a local or regional basis.
Questions and Answers on pesticides labeled for use on commercially grown tree fruits (LC06-0004):
1. Can pesticides that are labeled only for use on commercially grown tree fruit (such as apples) and are not Federal Restricted Use Products (RUPs) be applied by homeowners to control pests in backyard (noncommercial) apple orchards?
  
  A homeowner could legally apply the pesticides if they intended to make a profit from the fruit. Since the word "commercial" is commonly defined as engaged in commerce or intending to make a profit, the home owner would only have to show he or she intended to make a profit from the fruit in order to be within the bounds of the uses allowed on the label. Use in a noncommercial orchard would be inconsistent with the product's labeling and a violation of FIFRA.
2. If the homeowner can apply these pesticides, then are any of the WPS requirements (such as PPE and REI) applicable?
  
  If the label carries WPS requirements such as PPE or REI and use is limited to commercial applications all applicators including homeowners would have to comply with them. The homeowner and his or her immediate family would be exempt from certain WPS requirements such as posting notifications because they are the "Owners of [an] agricultural establishment" as described in 40 CFR 170.104(a). Specific WPS requirements from which the homeowner would be exempt are listed in 40 CFR 170.104(a) (1).
3. If the homeowner cannot apply these pesticides, then could they hire a commercial applicator to treat their apple orchard with these products?
  
  The homeowner could always hire a commercial applicator, but the answers to questions 1 and 2 apply since the labeling deals with pesticides labeled for use on commercially grown tree fruits versus a restriction requiring a commercial applicator to apply the product. The hired commercial applicator could only apply the pesticide to the homeowner orchard if the fruit it is intended for commerce and the commercial applicator would need to follow WPS requirements. The homeowner as "owner of [an] agricultural establishment" would be required to follow all WPS requirements if the commercial applicator is not a member of the homeowner's immediate family.
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8. Distributors

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 152.135(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 152.135(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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9. Establishment Numbers

Does the establishment number have to be on the master label before EPA will stamp the label? (LC07-0108; 09/11/2007)

No. 40 CFR 156.10(f) states: The producing establishment registration number preceded by the phrase “EPA Est.”, of the final establishment at which the product was produced may appear in any suitable location on the label or immediate container. Since the establishment number does not have to be on the printed label, but may be placed on, printed on, or embossed onto the container itself, it is not necessary for the establishment number to be on the master label.
Does changing of an EPA Establishment Number appearing on an approved label require notification or may the EPA Establishment Number be changed without notification? (LC97-0093)

The EPA Establishment number can be placed on either the label or the product container. PR Notice 98-10 allows under Non-Notification, factual statements about where the product is made, which could include the Establishment Number. Therefore, the number can be changed without notification. The product must indicate the Establishment Number of the final establishment at which the product was produced.
Pesticides are often stored at a terminal facility in large stationary bulk tanks prior to shipment to a customer. Is an EPA establishment number required if the terminal transfers pesticide product from one tank to another? What establishment number would go on the tank, the formulator’s or the terminal’s? (LC06 – 0077)

If the terminal is transferring pesticides as part of the distribution of the product, it is not required to register as an establishment. The transfer is considered part of the process of shipping the pesticide to the retailer and ultimately the end-user. If, however, the terminal is transferring the pesticide to another container acting as a refilling establishment, the terminal must register as an establishment and put it’s establishment number on the refilled container.
We ink jet lot numbers on the primary container and master case. Also, registration and establishment numbers are printed on the primary label as well as the master case label. Do the registration and establishment numbers need to appear on the master case? (LC06 - 0075)

The registration and establishment number are not required to appear on the master case if the pesticide product is removed from the master case before being sold to the end-user. If the master case is the outer container as customarily distributed or sold to the user, 40 CFR 156.10(a)(4)(i) requires that the full label must appear on the master case, including the registration and establishment numbers. As a matter of general practice, EPA recommends that the master (outer) case bear identification of the product within to allow quick identification of the product in the case of an accident or spill. In addition, the person shipping the pesticide must ensure that the shipment meets all applicable Department of Transportation (DOT) regulations.

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10. Exception to Use in a Manner Not Permited (FIFRA Sec 2ee)

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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11. Existing Stocks

As follow-up to the EPA answer regarding Existing Stocks which states "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."(see LC07-0094) Would you please clarify if this 18-month provision is applicable to label amendments that results in an EPA stamped approved label only - i.e., excludes label notification changes submitted by registrant? (LC07-0125; 11/1/07)

Label notification changes submitted by the registrant are label amendments and subject to the same 18-month provision for existing stocks. The 18-month period for changes made by notification begins upon the Agency’s receipt of a valid notification with the exception of changes made by notification for antimicrobials. In the case of a notification of a change to an antimicrobial label, the 18-month period begins upon acceptance of the notification. See FIFRA § 9(C)(i). In either case, if the Agency finds that the change could not appropriately be made through notification then the label change must be resubmitted as an amendment and the 18-month period would begin upon EPA’s acceptance of the amendment.
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.

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12. Final Printed Labeling

In the label review manual, Section 3, regarding Final Printed label/labeling. Please clarify. Would submission of a pdf that is sent to the printer constitute a Final Printed Label or would this still be considered draft? Does a registrant have to take a 2- step approach with the Agency to accommodate state submissions such that a pdf is submitted as an FPL with 2 copies of the actual printed version sent at a later time when available? If a pdf is considered draft labeling, how is the registrant notified that it has been provisionally accepted and within what timeframe? How long does the registrant have to submit the actual printed material? Thank you. LC08-0129; 12/13/07

Since the promulgation of EPA's regulatory labeling requirements for pesticides in 1975, technology to produce true and accurate representations of final printed labeling has significantly advanced. To that end, true and accurate representations of final printed labeling for each pesticide product as marketed will be acceptable to meet the requirements of 40 CFR 156.10(a)(6). Generally a provisional draft master label will be reviewed and stamped accepted prior to the submission of final printed labeling. OPP strongly encourages applicants and registrants to submit draft labeling electronically. See http://www.epa.gov/oppfead1/eds/edsgoals.htm for more information. Final printed labeling is not stamped approved by the Agency but is filed in the jacket of each pesticide as a record of the label with which the product is being marketed.

13. Globally Harmonized System for Hazard Communication

Will the Agency allow the use of the GHS explosiveness symbol and the GHS flammability symbol on pesticide labeling? Is use of these symbols limited to NAFTA labels? (LC08-0162; 5/15/08)

The Agency will allow the use of the GHS (Globally Harmonized System for Hazard Communication) explosiveness symbol and the GHS flammability symbol on pesticide labeling and it is not limited to NAFTA labels. 40 CFR 156.78 requires warning statements on the flammability or explosive characteristics of pesticide products meeting listed criteria. These statements, as applicable, must remain on labels that choose to in addition use the GHS symbols. Further, 40 CFR 156.78(d)(3) requires a flammability symbol specifically for total release fogger products and offers an example symbol. The GHS flammability symbol is equivalent and may replace the example provided. GHS symbols may be added by a label amendment and may not be added through notification. The GHS symbols allowed are:

14. Labeling Advisories

In addition to the boilerplate surface water label advisories found in the label review manual, numerous other surface water label advisories can be found on labels. Is the language found in the label review manual just guidance to be modified on a case-by-case basis, and if so, is there any other criteria used to determine which language will be used? (LC08-0196)

The boilerplate surface water advisory language found in the Label Review Manual is an example of a warning statement that has historically been required on pesticide labels based on: their tendency to run-off and drift; and their potential surface water impacts associated with the use pattern, environmental fate properties of the pesticide, and eco- or human health risks. These environmental fate and risk issues are typically identified during the pesticide risk assessment process. Beyond the boilerplate statement in the label review manual, label advisories may be modified on a case-by-case basis to reduce risk to humans and the environment based on the specifics of the pesticide being reviewed.

15. 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.

16. Miscellaneous

I would like to know or have someone define the term EPA File Symbol number on a section 18 product. Why does the product not have an EPA Registration number? (LC08-0183)

An EPA file symbol (a registrant’s company number followed by a sequence of letters) is a symbol that the Agency uses to identify a pending new product registration action. Once the agency completes action on an application for registration of a new pesticide product and registers the product, the file symbol is changed to a registration number (a registrant’s company number followed by a set of numbers).

Under section 18 of the Federal Insecticide, Fungicide and Rodenticide Act the Administrator may authorize the use of an unregistered pesticide or unregistered use of a registered pesticide (including an unregistered pesticide product) if an emergency condition exists as described under
40 CFR Part 166. Some products authorized for use under section 18 have been submitted for registration and have therefore received an EPA file symbol. The agency has not taken final action with respect to registering the product but has authorized its use under section 18.
These products could have an EPA file symbol assigned to them and that symbol may be included on a label, however, the product may only be used in accordance with a section 18 exemption granted by the Agency.
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.
Chapter 8. II. D. 4 of the Label Review Manual indicates when Ground Water Advisories are "generally" required. However many labels for outdoor use meeting the specified thresholds do not have such advisories. Imidacloprid meets the specified thresholds for the advisories and has been detected in ground water in Long Island, NY. The labeling for the agricultural product has the ground water advisory, but the label for the termiticide product does not. Why the inconsistency? LC08-0143; 1/10/08

As pointed out in the Chapter 8.II.D.4, Ground Water Advisories are “generally” required. The ground water advisory is a case-by-case basis determination depending on the use site and available data. Termiticides uses are generally considered indoor uses because applications involve injection through drilled holes in slabs of constructed houses, or for pre-construction, the soil is sprayed just before the foundation is poured. Under such circumstances, OPP has not generally required ground water advisories.
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.
Can aerosol cans containing pesticides be punctured by a disposal facility if the label states "do not puncture or incinerate"? LC08-0146; 12-13-07

A pesticide container, even empty, is still a “pesticide product” as defined at 40 C.F.R. §152.3, and is therefore still subject to FIFRA. As part of its process for approving registration of a pesticide product, EPA considers the applicant’s proposed disposal instructions. See 40 C.F.R. §156.10(i)(2)(ix) (“The directions for use shall include the following, under the headings ‘Directions for Use’: ... Specific directions concerning the storage and disposal of the pesticide and its container, meeting the requirements of 40 CFR part 165.”). Disposal is thus a “use,” and use of a registered pesticide in a manner inconsistent with its labeling is a violation of FIFRA section 12(a)(2)(G).

FIFRA section 2(ee)(6), however, authorizes the Administrator to permit a “use inconsistent with the label” if he determines that the use of the pesticide is “consistent with the purposes of [FIFRA].” These purposes may be broadly summarized as “to provide for the protection of man and his environment....” [ S. Rep. No. 92-838, at 3 (1972)].

EPA’s regulations in 40 C.F.R. §156.78(b) require the labels of pressurized pesticide containers to include the statement “Do not puncture or incinerate container.” [EPA has issued guidance authorizing pesticide registrants to amend existing labels in order to expressly allow recycling of empty aerosol pesticide containers. See Pesticide Registration Notice 94-2 (May 16, 1994)] This requirement predates [See 36 Fed.Reg. 22496 (Nov. 25, 1971), promulgating the “Do not puncture or incinerate” requirement for pressurized pesticide containers, then codified at 40 C.F.R. §166.113(f)(3)] the enactment of the Federal Environmental Pesticide Control Act of 1972 which dramatically amended FIFRA, as well as the federal regulatory program for hazardous wastes, the Resource Conservation and Recovery Act of 1976. Although the regulation originally may have been intended to protect users in their largely unregulated disposal of pressurized containers, such disposal practices have been replaced by a more centralized and highly regulated waste management industry.

EPA’s view is that the present purpose of the “Do not puncture or incinerate” instruction is to protect the ordinary users of pesticides from the hazards of pressurized containers. EPA believes that the hazards associated with recycling aerosol pesticide containers are adequately, and more appropriately, addressed under federal, state and local laws concerning solid and hazardous wastes and occupational safety and health. While EPA believes that these hazards are already adequately addressed through other authorities, EPA believes that any remaining risk that might arguably be subject to FIFRA is small and outweighed by the benefits of recycling the aerosol containers. Therefore, EPA has determined that the puncturing of disposed aerosol pesticide containers for recycling is consistent with the purposes of FIFRA, provided that:

The puncturing of the container is performed by a person who, as a general part of his or her profession, performs recycling and/or disposal activities;
The puncturing is conducted using a device specifically designed to safely puncture aerosol cans and contain the residual contents; and
The puncturing, waste collection, and disposal, are conducted in compliance with all applicable federal, state and local waste (solid and hazardous waste) and occupational safety and health laws and regulations.

Failure to comply with all these conditions when puncturing aerosol pesticide containers would constitute use of a pesticide product in a manner inconsistent with its labeling and may result in the imposition of penalties under FIFRA.

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.
For rodenticides in particular, when the label reads "product may be used to control rats in and around home, buildings, etc.", what is the maximum distance from a home, building etc. that the product may be used? (LC07-0121: 11/1/07)

The term in or around home, buildings, etc., has not been defined from the standpoint of a maximum distance. However, the Agency’s current view is that rodenticide baits intended for use by the general public should only be used indoors and against the outside walls of buildings. EPA intends to require rodenticide registrants to amend those labels that currently allow placement of rat and mouse baits “in and around buildings” to delete that phrase and add language limiting use to “indoors and against the outside walls of buildings.” See 1998 Rodenticide Cluster RED, pp. vii, 106 and 119.
What is the difference between the label signal words "dermal sensitizer" and "dermal irritant"? I understand the fact that there are four categories for dermal irritation, whereas there is only one for dermal sensitization, either the product is or is not a dermal sensitizer. Dermal irritants can cause erythema and edema, whereas dermal sensitizers have the potential for allergic contact dermatitis. However, contact dermatitis can be characterized by erythema (redness of the skin) and edema (essentially swelling). I could use some clarification. Thank you much. (LC07-0119; 9/24/07)

First, "dermal sensitizer" and "dermal irritant" are not signal words. Signal words are described in 40 CFR 156.64 and are limited to "Danger," "Warning," and "Caution." Signal words are associated with four numbered EPA toxicity categories. These numbered toxicity categories correspond to the following tests: oral and dermal LD50, inhalation LC50, eye and dermal irritation. These tests are based on a single exposure to a substance. In contrast, dermal sensitization is an immunologically mediated cutaneous reaction to repeat exposures to a substance. Dermal sensitization is not part of the numbered toxicity categorization scheme. Pesticides either are or are not dermal sensitizers. Whether a pesticide is a dermal sensitizer is based on tests as described in OPPTS 870.2600. You are correct that the two endpoints (dermal irritant and dermal sensitization) correlate; and that is why the OPPTS 870.2600 skin sensitization procedures state the highest nonirritating dose be used for the Beuhler and GPMT tests. While no signal word is associated with dermal sensitization, products that test positive for dermal sensitization may be required to bear precautionary label language for this endpoint such as: "Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals." See 40 CFR 156.70.
What is OPP’s policy with respect to embossed labeling? (LC07-0099; 09/11/2007)

Embossed labeling must meet the requirements of 40 CFR Part 156.10(a)(2)(i) and (ii). These sections require that:

“(i) All words, statements, graphic representations, designs or other information required on the labeling by the Act or the regulations in this part must be clearly legible to a person with normal vision, and must be placed with such conspicuousness (as compared with other words, statements, designs, or graphic matter on the labeling) and expressed in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
(ii) All required text must:
be set in 6–point or larger type;
Appear on a clear contrasting background; and
Not be obscured or crowded.”

In general, our preference is that the lettering be adequately raised to be seen clearly and be colored in a pastel color. In the past OPP has found that pastel colors work best for making the label clearly legible and other colors may not be legible and therefore not allowed. OPP also prefers that registrants remove use site language which is not needed on the distributed label if the product is actually being sold or distributed for just a subset of all of its registered uses, so that all label language can be set at a type size greater than 6 point if possible (i.e., If a product is being marketed just for swimming pool use, the cooling tower use language could be left off that label.). 40 CFR 152.130(b) allows distribution under a subset of approved labeling provided no changes would be necessary in precautionary statements, use classification or packaging.
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.
Some pesticide products have a container label and a booklet containing the directions for use attached to the container. The EPA Label Review Manual spells out the requirements for the container label but it does not specify requirements for the booklet. What are the minimum requirements for booklet labels? Do they need to have the EPA registration number? What other information must be included in these booklets? LC06-0068

The booklet is considered “labeling,” defined in part as: “all labels and all other written, printed, or graphic matter (A) accompanying the pesticide or device at any time; or (B) to which reference is made on the label or in literature accompanying the pesticide or device.” FIFRA § 2(p)(2). Labeling must meet the requirements of 40 CFR Part 156 and must not be false or misleading. Most of Part 156 speaks directly to what must be on the affixed label, however, EPA allows in 40 CFR 156.10(i)(1)(ii) for directions for use to be printed on labeling other than the affixed label such as in booklets, at the Agency’s discretion. EPA has not set forth minimum label requirements for accompanying literature (booklets). However, when directions for use will appear in accompanying literature such as a booklet, EPA will work with the registrant to determine what other labeling elements must also appear in the booklet so that the labeling as a whole is not false or misleading and ensures proper usage of the product.
An antimicrobial product formulated as a strip is sold in a package containing 12 and 24 strips. At the present, the label is placed only on the outer package and not on the individual units. Do the individual units also require a label? (LC06-0071)

Because the strips themselves are the pesticide product, they do not need to be individually labeled because 40 CFR 156.10(a)(4) requires labels to be securely attached to the immediate container of the product and not the product itself. If the strips were sold or distributed individually, then the individual package for each strip would need to be labeled. To ensure that the strips are not sold or distributed individually, one might consider adding to the label(s) a statement such as “Individual strips are not for resale.” With today's technologies, it may be difficult to determine what is the immediate container and whether your product is correctly labeled. We encourage applicants and registrants to discuss your packaging options when discussing labeling in order to avoid possible misbranding violations once the product is sold or distributed.
Does the Label Review Manual (LRM) Chapter 3 section entitled "Container Label Contents When Booklets are Used" also apply when a product is attached to a "blister card" for sale? That is, does minimum labeling on the bottle need to include the eleven listed items and the rest of the information can be on the card that holds it? Where should the First Aid Statement appear? (LCO6-0069)
FIFRA and the Agency's implementing regulations establish the applicable requirements for which statements must be on the product label itself. In particular, 40 CFR 156.10(a) requires certain items to be included on the affixed label while 40 CFR 156.10(i)(1)(ii)(B) allows limited flexibility by allowing the directions for use to appear elsewhere if properly referenced on the affixed label. The affixed label must be "securely attached," meaning it can reasonably be expected to remain affixed during "the foreseeable conditions and period of use of the product." Generally, it is not acceptable to print the required label items only on the "blister card" because the blister card is a part of the packaging that is usually discarded as the product is opened and therefore could well be discarded even before the user first begins to actually use the pesticide product (and is almost certain to be discarded before additional applications if the product is used more than once).

The First Aid Statement is part of the precautionary statements that are required to be on the affixed label according to 40 CFR 156.10(a)(vii).
From the EPA Chemical Resistance Category Chart (in reference to the Worker Protection Standards) what do the letters A-H Represent? (LCO6-0066)

The letters A - H in the Chemical Resistance Category Chart contained in Chapter 10 of the Label Review Manual (LRM) refer to solvents categorized as to the chemical reaction to certain chemical resistant material, i.e., nitrile rubber, laminate barrier, viton.. These solvents are used in pesticide products subject to the Worker Protection Standard (WPS). The lettered groups are used by pesticide users to select the appropriate type Personal Protective Material from the chart.

A list of solvents and which category they fall in can be found in Supplement Three, the Main Labeling Guidance of PR Notice 93-7, issued by the Agency on April 20, 1993.
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 exemptio