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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. These answers are primarily based on federal law, regulations and policies implemented by EPA. States, tribes, territories, and other federal agencies may have additional requirements relevant to their jurisdictions.
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Can a manufacturer advertise that their product does not contain a certain active
ingredient (e.g., &#;DEET free&#;)? LC21-; 10/14/21
Claims such as &#;free of [active ingredient]&#; or &#;contains no [active ingredient]&#; may constitute misbranding and may need to be removed. EPA is concerned that users might understand these types of statements to be safety claims. This could give users the impression that products without a certain active ingredient are safe or safer than products with the active ingredient, which may be false or misleading. Safety claims are considered false or misleading statements that constitute misbranding under 40 CFR 156.10(a)(5)(ix) and (x). Misleading comparative claims about the safety of the product versus other products also constitute misbranding under 40 CFR 156.10(a)(5)(iv) and (vii). These claims are therefore disallowable under FIFRA sections 2(q)(1)(A) and 12(a)(1)(E).
Consumers can readily determine if a pesticide product contains an active ingredient (e.g., DEET) by reviewing the active ingredients listed on the front panel of the label in accordance with 40 CFR 156.10(g). Because all active ingredients must be listed, the absence of an active ingredient in the ingredient statement would indicate it is not in the product.
40 CFR 152.25(a) provides an exemption from the requirements of registration for qualified treated articles or substances. The exemption provision states that &#;an article or substance treated with, or containing, a pesticide to protect the article or substance itself (for example, paint treated with a pesticide to protect the paint coating, or wood products treated to protect the wood against insect or fungus infestation), [is exempt] if the pesticide is registered for such use.&#;
If your product otherwise qualifies for the treated article exemption, you may make claims about the pesticide in your product so long as each of the requirements cited above continues to be met and none of your claims or statements state or imply in any way that the pesticide provides any benefit beyond mere protection of the treated product itself.
If any of the above-cited requirements are not met or if any of the statements or claims state or imply in any way that the pesticide is protecting more than the treated product itself, the treated product would need to be registered.
Pesticides qualify for an exemption from registration requirements as described at 40 CFR 152.25(f) [promulgated under the authority of FIFRA 25(b)] if they:
One of the conditions in 40 CFR 152.25(f)(3) is that such product "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.&#; While the Agency does consider bedbugs to be pests of significant public health importance (see PR Notice -1), the claim &#;bedbugs are small parasitic insects that feed on the blood of humans. Use ... to eliminate infestation&#; does not indicate that bedbugs carry specific diseases and therefore does not itself disqualify a pesticide product from the exemption.
Another condition in 40 CFR 152.25(f)(3) is that the pesticide labeling not include any false and misleading statements. To meet this condition, all claims, such as a claim that the product will eliminate bedbug infestation, should be substantiated in accordance with the Federal Trade Commission&#;s guidelines for substantiating advertising. More information on FTC's guidelines.
FIFRA section 2(u) defines pesticide, in part, as &#;any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest.&#; As explained in 40 CFR 152.15(a), when a person distributes or sells a substance with claims that it can or should be used for a pesticidal purpose (e.g. preventing, destroying, repelling or mitigating pests), the substance must be registered unless it has otherwise been exempted from the requirement for registration in 40 CFR 152 Subpart B.
Product claims are considered to be pesticidal if they are synonymous with &#;preventing, destroying, repelling, or mitigating pest.&#; Claims are judged on a case-by-case basis considering the context in which they are made, but it is likely that a claim that mulch &#;resists insects&#; would be considered a pesticidal claim because "resisting" pests is similar to "preventing, destroying, repelling or mitigating" pests.
One exception is products containing no toxicants that are intended to exclude pests only by providing a physical barrier against pest access are not considered pesticides because EPA has determined they are not intended for a pesticidal purpose. 40 CFR 152.10(c). Unless the mulch fits this exception or is otherwise exempt, it would need to be registered to be sold or distributed in the United States. For more detail on what pesticide products are exempt from registration requirements see Pesticide Registration Manual: Chapter 1.
The label statement &#;removes pathogens and microbes down to 2 microns&#; is a pesticidal claim. In order for the product to qualify as a barrier product under 40 CFR 152.10(c), the product the following conditions must be met:
Based on the criteria listed above, this product does not appear to qualify as a barrier because it makes a pesticidal claim and is intended to mitigate a pest (the pathogens) . The product would also not be classified as a pesticidal device since it contains a substance &#;diatomaceous earth,&#; which is contained in a number of EPA registered products. Therefore, this product would be a pesticide and subject to regulation under FIFRA.
Historically, EPA has allowed the claim "new" to be used on labeling for a period of six months following approval of a new registration. "New" has not historically been allowed as part of a product name. Terms or marketing claims such as "improved," "next generation," etc. are reviewed on a case-by-case basis to determine whether they are false or misleading and therefore not allowable. A review of the complete label is needed to determine the acceptability of such terms. See Label Review Manual, Chapter 12, Section VII.
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:
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.
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.
While the Agency reviews proposed contact times for disinfectant products on a product-by-product basis, in general, the Agency does not accept a hard surface disinfectant contact time of greater than 10 minutes unless the material to be disinfected is to be immersed in the disinfectant product solution as part of the disinfection process. Disinfectants that are applied to surfaces that are not immersed in the disinfectant product solution will dry out and therefore contact with the disinfectant product solution will generally not last longer than 10 minutes.
The Agency recommends the use of the AOAC International Use-Dilution Methods or the AOAC International Hard Surface Carrier Test Methods (distilled water only) to develop efficacy data to support a disinfectant claim. These methods specify a contact time of 10 minutes or less. In addition, on January 27, the Agency made available to the public for comment its draft proposed 810. Series Product Performance Guidelines which included draft proposed guidelines for disinfectant treatment of hard surfaces. The proposed disinfectant guidelines for use of antimicrobials on hard surfaces (810.) would, once they are final, specify that disinfection of hard surfaces be achieved within a disinfectant product contact time of 10 minutes or less.
EPA does not have jurisdiction over cleaning products that make no pesticidal claims. However, a label that compares properties of a cleaning product to those of a registered pesticide product appears to make a pesticidal claim, which would likely result in the need to register the cleaning product bearing such claim.
There are no &#;standard levels&#; of a quaternary ammonium that can be used for sanitization. The dosage rate for a sanitization claim is determined by efficacy data that are required to be submitted since sanitization is a public health claim. There are limits established in 40 CFR 180.940 (tolerance exemptions for food contact sanitizers) regarding the ppm level of a solution containing a quaternary ammonium that can be used on a food contact surface. For some quaternary ammonium compounds the maximum level is 200 ppm while for other quaternary ammonium compounds the solution can contain up to 400 ppm. The rate specified on the product label determines the ppm level that can be used in a sanitizing solution whether it is used on non-food or food-contact surfaces.
Residues of sodium hypochlorite in water are measured as available chlorine. In , the Office of Water (OW) working with the Office of Pesticide Programs (OPP) established a maximum residual disinfectant level (MRDL) of 4.0 mg/L (ppm) for chlorine (40 CFR 141.54) that is allowable in community water systems (CWSs) and nontransient noncommunity water systems (NTNCWs) from either a primary or secondary disinfectant treatment. View the Federal Register Notice for the final rule (88 pp, 1,011K, About PDF).
In general, the Agency does not identify and/or recommend specific pesticide products. Therefore, we suggest that you contact your local water utility to determine what disinfectant products they may be using.
In general, there are no differences in the precautionary statements required for a hospital product versus a residential product. Precautionary statements may vary among specific products due to the hazards that may be posed by the particular product in question. The major differences between product labels for hospital products versus residential products are differences in the use directions including the use sites and pests.
A &#;General Precautions&#; statement is not a required label statement and thus does not have to be used on either a hospital or a residential product. Many companies choose to use that format to organize the precautionary information provided to the user. The precautionary statements required on a label are specified in Subparts D and E of 40 CFR Part 156. Further, EPA may require product specific precautionary label statements on a case-by-case basis through the registration process.
In general, the Agency requires registrants to submit efficacy data to support all public-health-related label claims. If a registrant wants to list a specific public-health microorganism on their product label, they would need to generate and submit efficacy data showing the product is effective against that specific microorganism.
In the case of H1N1, the Agency believed a different approach was needed due to the emerging threat posed by the spread of Pandemic H1N1 Influenza A Virus. Thus, the Agency used an approach based on the determination that data submitted to support a claim for control of any Influenza A virus was sufficient to support a label claim against Pandemic H1N1 Influenza A virus. This determination was in part based on the fact that efficacy data that support use against Influenza A also support use against different strains within the same type of virus. See Guidance for Testing and Labeling Claims against Pandemic H1N1 Influenza A Virus. Search EPA Archive
However, in the case of Salmonella, 1) the pandemic scenario is not present and 2) the genus of Salmonella is a much broader category of organisms than is encompassed by the Influenza A virus type. Species of Salmonella include those that are resistant to antibiotics as well as those associated with food-borne illness or typhoid fever. Efficacy data on a singles species are not adequate to support a general Salmonella claim; therefore, data must be submitted to support each Salmonella species listed on the label.
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 Disinfectants for Use on Hard Surfaces.
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.
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.
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).
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-; 7.8.08
In September , EPA initiated a pilot program to allow claims of biodegradability for products meeting certain criteria. The criteria are posted on the Agency's website at: the Pilot Criteria for Biodegradability Claims On FIFRA Registered Products On FIFRA Registered Products.
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.
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 an FDA model (Chemistry recommendations, appendix I, II, III, IV, V) that takes into account application rates, residual solution, area of the treated surface that 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.
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 United States. 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.
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.
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.
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 * * *."
In accordance with 40 CFR § 153.155(a), &#;[p]esticide products intended for use in treating seeds must contain an EPA-approved dye to impart an unnatural color to the seed, unless appropriate tolerances or other clearances have been established under the Federal Food, Drug and Cosmetic Act for residues of the pesticide.&#; Seeds can either be planted in order to derive a food commodity that is grown from the seed, or can be a food crop if they are to be used directly as food or feed. The inert tolerance exemptions found in 40 CFR 180.920 for pre-harvest uses apply to formulations applied to growing crops only. Because seed is not a growing crop when it is treated, an exemption under 40 CFR 180.920 is not sufficient to escape the requirement to include a dye in the pesticide product used for the treatment.
For the purposes of the Worker Protection Standard (WPS), 40 CFR 170.3 defines "greenhouse" as "any operation engaged in the production of agricultural plants inside any structure or space that is enclosed with nonporous covering and that is of sufficient size to permit worker entry. This term included, but is not limited to, polyhouses, mushroom houses, rhubarb houses, and similar structures." EPA has not defined "greenhouse" in the context of use sites but the WPS definition is instructive. If a cold frame is enclosed with nonporous covering and is large enough to permit worker entry, it would likely be considered a greenhouse.
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.
In-furrow treatments are always done at-plant where the granules or liquid is applied into an open seed furrow just before it is closed by the presswheel. The pesticide resides only at the bottom of the seed furrow.
Banded applications are done at-plant over a closed seed furrow, postplant over the row, or post-emergent often as a side-dress application. They are usually superficially soil incorporated with drag chains or tines.
A banded application at-plant over an open seed furrow, is called a T-band.
Preplant applications are usually broadcast over the entire field and incorporated. They are usually referred to as Preplant Incorporated or PPI.
EPA published definitions and policies related to food-handling establishments in the Federal Register on August 10, , available at 38 FR . 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.&#;
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.&#;
EPA does not have a definition for high and low level disinfection. These are terms used by FDA. More information on high and low level disinfectants. Also see guidance on review by FDA.
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.
In accordance with 40 CFR 152.132, a registrant, and only the registrant, may sell and distribute its registered pesticide product under another person's name (i.e., the "supplemental distributor" or "subregistrant"). A supplemental distributor may not sell or distribute the registrant's product under another person's name.
For the scenario above, in order for the product to be sold or distributed under Company B&#;s name, Registrant R must enter a supplemental distributor agreement with Company B using EPA Form -5, which must be submitted to EPA prior to distribution.
You cannot do any of the activities you describe without the consent of the registrant. Even with the consent of the registrants, there are limitations.
In accordance with 40 CFR 152.132, the registrant may enter in a supplemental distributor agreement with another party to distribute a registered product under another person&#;s name and address instead of or in addition to the registrant&#;s own. For a supplemental distributor to distribute a pesticide, the registrant must notify EPA and the distributor must complete a Notice of Supplemental Distribution of a Registered Pesticide Product (EPA form -5) signed by both the registrant and the distributor. 40 CFR 152.132 limits what can differ about a distributor product from the registered product. The distributor may only package the registrant&#;s product if the distributor is the same producer (or under contract in accordance with 40 CFR 152.30) as the producer who produces, packages, and labels the registered product. See 40 CFR 152.132(b). Further, the distributor product may not be repackaged (i.e. it remains in the producer&#;s unopened container). See 40 CFR 152.132(c).
The label of the supplemental registrant&#;s product must be the same of the registrant with the exception that:
The registrant must ensure that the EPA-approved labeling of the registered product includes appropriate statements for refillable containers in accordance with 40 CFR 156 Subpart H.
Because you are the producer of the pesticide and the distributor is not, the distributor would not be able to repackage the product into smaller containers even with a supplemental distributor agreement with the registrant. Under a supplemental distributor agreement you may be able to change the product name and the distributor name, address and number. But without a change to the EPA-approved label of the registered product, you cannot change the storage and disposal language.
In accordance with 40 CFR Section 156.10(c), &#;An unqualified name and address given on the label shall be considered as the name and address of the producer. 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.&#; FIFRA 2(p)(1) defines &#;label&#; as &#;the written, printed, or graphic matter on, or attached to, the pesticide or device or any of its containers or wrappers.&#; Thus any writing appearing on the pesticide label is considered part of the label that must be approved by EPA and may not be false or misleading. Changes to the label specifying &#;Packed for&#;.Distributed by&#;or Sold by&#;&#; are not specified in PR Notice (PR) 98-10: Notifications, Non-Notifications and Minor Formulation Amendments and therefore these label changes are considered amendments.
In general, EPA allows the use of parentheses on a label unless:
The example you cite where you provide correct ppm information to the user based on the rate on the label would generally be an acceptable use of parentheses on a label.
Please note, however, that 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 present statements in parentheses on a label unless the master label of the parent product also contains the same statements in parentheses. Further, the supplemental distributor may not delete statements in parentheses that appear on the parent product's label unless they involve one of the changes allowed in 40 CFR 152.132(d).
The supplementally distributed product must bear the same information as the parent product with the exception of the information listed in 40 CFR 152.132(d). Except for the pieces that may change, the wording must be identical. The layout and format of the label of the supplementally distributed product may differ from that of the parent product so long as the change in layout or format doesn&#;t make the label false or misleading.
Example:
Primary Container label
Manufactured for
ABC Company
Distributed by or sold by:
XYZ Company
A registrant could add the suggested language you propose as a second label indicating a distributor company name, if the change were reflected on the master label for the product. See 156.10(c). Generally, all information on labeling needs to be approved by EPA in what is collectively referred to as the "master" label. Products can be sold or distributed with a subset of the master labeling provided no changes would be necessary to precautionary statements, use classifications or packaging. To add an alternate distributor name, a registrant could list the standard company name on the master label and include alternates that would be used as appropriate on products depending on how they are distributed. If added as alternative language on the master label, EPA would not treat this scenario as a supplemental distribution as described in 40 CFR 152.132. FIFRA 2(p)(1) defines "label" as "the written, printed, or graphic matter on, or attached to, the pesticide or device or any of its containers or wrappers." Thus any writing appearing on the pesticide is considered part of the label that must be approved by EPA and may not be false or misleading. Adding distributor information to the master label, however, may have no effect on state registration fees, which are governed by state laws.
40 CFR § 152.132 states: &#;the label of the distributor product is the same as that of the registered product&#; with listed exceptions. One listed exception is that the distributor may delete specific claims that are found on the basic registrant&#;s label. Distributors may not add claims that don't appear on the basic registrant's label. EPA considers placement on the label of a third-party certification such as the NSF logo to be a claim, and therefore a distributor may not add it to the distributor label unless it also exists on the label of the basic registrant&#;s product. For guidance on the use of the NSF label generally, see NSF Logo Letter.
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.
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.
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
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).
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).
40 CFR § 152.132(c) generally limits the changes that can be made between a registrant&#;s label and a supplemental distributor&#;s label to the:
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, ). 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 the Guidance on Warranty Statements
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:
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.
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. See more information on establishment registration process and reporting obligations.
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 -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.
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.
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)).
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).
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).
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.
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.
Sold By:
XYZ Distributors
Anywhere, USA
A distributor may not place a tag or sticker to a product as this is considered labeling and the product would be considered misbranded.
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.
States may further restrict the use of pesticides by enacting state requirements that do not contradict the federal labeling. For example a state could ban the use of a product at less than the labeled use rate, which FIFRA section 2(ee) normally would allow. A state could also place additional restrictions on the use of the product within the state to protect sensitive use sites such as greenhouses.
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).
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.
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.
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) 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.
On October 22, , EPA published a notice in the Federal Register (46 FR ) 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 ) dated May 28, , 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.
There is no recommended expiration period for a FIFRA section 2(ee)(1)-(5) recommendation.
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, , 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 , which regulation or advisory opinion specifically requires the use of definite amounts of dilution. "
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).
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.
Specifically:
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.
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.
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.
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.
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.
When a product registration is transferred from Company A to Company B, EPA allows Company B to sell and distribute existing stocks of the product for 18 months. Existing stocks are stocks that were produced and released for shipment by the date of the transfer and therefore would bear labeling based on Company A's registration. Each container or package bearing Company A's labeling must be clearly and accurately marked with the batch number, lot number or other descriptive designation used to identify the product in Company B's records. After 18 months, if any existing stocks remain, they would need to be relabeled with Company B's labeling in order to be sold or distributed.
Any product produced after the date of the transfer must bear Company B's labeling, including the new company name and new EPA Registration Number.
All claims to be made for registered pesticide products must be submitted for review in accordance with FIFRA 3(c)(1)(C). Once claims are approved, registrants may choose from the approved claims, which will appear on the marketed product label. Claims may be omitted so long as the omission does not make the marketed label false or misleading. For supplemental distributors, there are limitations to what changes can be made to the approved label; however, regarding claims 40 CFR 152.132(d)(5) allows specific claims to be deleted from the product labeling provided that no other changes are necessary.
You cannot use the pesticide at a food site unless it fits into one of the approved sites listed on the label and there is no restriction against it. It should be noted that on products labeled for indoor, commensal rodent control that include the food processing facility site, the following language should appear - "Do not contaminate water, food, feedstuffs, food or feed handling equipment, or milk or meat handling equipment or surfaces that come into direct contact with food or feed. When used in USDA inspected facilities, this product must be applied in tamper resistant bait stations."
Pesticides which change in chemical composition (e.g., the amount of active ingredient degrades so that it falls bellow the EPA-approved certified lower limit) must bear the following statement in a prominent position on the label: "Not for sale or use after [date]." 40 CFR 156.10(g)(6)(i). The agency requires this statement for products that cannot demonstrate one year storage stability in product chemistry guideline number 830- for conventional pesticides and guideline 63-17 for antimicrobial pesticides. The product must meet all label claims up to the expiration date indicated on the label. For placement of the statement, we recommend it be placed on the front panel, either immediately below the product name or ingredient statement.
See also Label Review Manual Chapter 5, Section VIII(a). Expiration dates may appear on labeling for other reasons. If they do, the correct wording and placement is determined on a case-by-case basis.
The Agency treats sod farms as a separate use site from those on the directions for use list. Ornamental turf is not considered to include agricultural crop and sod farms are considered to be an agricultural crop. Since sod farms are not listed as a specific site for application on this label, and sod farms are not covered by the Agency's definition of ornamental turf, this pesticide can not be applied to sod being grown on sod farms.
FIFRA sec. 12(a)(2)(G) makes it a violation of federal law for any person "to use any registered pesticide in a manner inconsistent with its labeling." All registered pesticides, including registered consumer pesticides, must bear the statement:
"It is a violation of Federal law to use this product in a manner inconsistent with its labeling." 40 CFR 156.10(i)(2)(ii).
Section 2(ee) of FIFRA provides limited exceptions to what is considered "in a manner inconsistent with" labeling. For instance it is not a violation to use a pesticide at a rate lower than that specified on the label unless the label specifically prohibits deviation from the specified rate.
In general, EPA allows the use of parentheses on a label unless: 1) the parentheses are used in such a way that the labeling becomes false and/or misleading or 2) the use of the parentheses causes confusion making the directions for use inadequate to protect human health or the environment. The example you cite where you provide correct ppm information to the user based on the rate on the label would generally be an acceptable use of parentheses on a label.
Please note, however, that 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 present statements in parentheses on a label unless the master label of the parent product also contains the same statements in parentheses. Further, the supplemental distributor may not delete statements in parentheses that appear on the parent product's label unless they involve one of the changes allowed in 40 CFR 152.132(d).
The front panel is generally regarded as the part of the label that is (normally) visible to the user, consumer, etc. when the product is in a retail environment. At a minimum, the front panel must contain the following information:
In addition, generally the net weight or contents also appears on the front panel. See Label Review Manual Chapter 3, VII.
The Agency has not issued guidance on what specific 40 CFR Part 156 labeling requirements must be on device labels. However, some of the labeling requirements include but are not limited to that the device:
40 CFR 156.10(a)(4)(i) states that: &#;The label shall appear on or be securely attached to the immediate container of the pesticide product.&#; The regulations go on further to state: &#;If the immediate container is enclosed within a wrapper or outside container through which the label cannot be clearly read, the label must also be securely attached to such outside wrapper or container, if it is part of the package as customarily distributed or sold.&#;
If the pesticide product is customarily removed from the shipping container prior to being distributed or sold to the retail purchaser, the shipping container does not have to bear the full product label. If the shipping container is the unit which is customarily distributed or sold to the retail purchaser the shipping container must bear the full product label. Even where the shipping container is not required to bear the full product label, any information on the shipping container is labeling, and labeling that is false or misleading would be in violation of FIFRA. While the regulations do not specify particular labeling for shipping containers, the Agency recommends that the shipping container be labeled with enough information for emergency personnel to be able to identify the material in the shipping container in the event of an accident or spill. Be advised that DOT requirements may require labeling of the shipping container depending on the characteristics of the material being shipped.
Affixing a sticker to a container is considered labeling and therefore production as defined in 40 CFR 167.3. 40 CFR 167.20(a)(1) requires any establishment where production occurs to be registered. Affixing a sticker must take place in a registered establishment.
Generally, to be sold or distributed in the United States, a pesticide must be registered and must be labeled in accordance with the requirements of 40 CFR part 156. The label (all written, printed or graphic matter on, or attached to, the pesticide) and any other labeling (written, printed or graphic material which accompanies the product or is referenced to on the label) may not be misbranded (e.g. false or misleading) as set forth in FIFRA section 2(q)(1)(A) and 40 CFR part 156. Labeling language that is in addition to that required by FIFRA and its implementing regulations may be allowed if it is not false or misleading. Therefore, so long as the international labeling is not false or misleading, or otherwise causes the pesticide to be misbranded, it may be allowed on a product container (or accompanying the product) in addition to the U.S.-required labeling. Determining whether specific international labeling would be allowed requires a case-by-case comparison of the U.S. label and the international label.
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.
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).
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.
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 that 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. (For example, 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.
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 Rodenticide Cluster RED, pp. vii, 106 and 119.
Since the promulgation of EPA's regulatory labeling requirements for pesticides in , 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 Electronic Submissions of Labels 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.
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:
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.
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.
"Technical bulletin" is not a defined regulatory term under FIFRA and therefore it is important to understand the nature of the bulletin described in order to answer. Upon clarification, it was found that the technical bulletin described in the question is a marketing brochure to sell the product and to provide information to customers and is not labeling as defined by FIFRA § 2(p). It would not accompany the product and there is not a reference to the bulletin on the product label. EPA does not have requirements for statements included on such a technical bulletin that is not a part of the labeling. However, it must not have claims that differ from the product label. See FIFRA § 12(a)(1)(B). If a registrant wishes to include additional claims in non-labeling marketing materials, such claims must be submitted as part of the statement of claims to be made that is required for registration under FIFRA § 3(c)(1)(C).
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, states that advisory statements can be deleted by notification. Is this still the case? (LC08-; 5/15/08)PR Notice -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, -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.
PR Notice 98-10 discusses the revision, addition or deletion of non-FIFRA related label elements through non-notification. The PR Notice goes on to list lot or batch codes, bar codes or other production identifiers as examples of changes that may be made to product without notifying EPA. Provided the bar code sticker is not being added to label to meet a labeling requirement and the bar code does not cover or obscure any required label element, EPA does not consider the placement of the bar code sticker on cartons and containers to be production that must occur in a registered establishment.
Under the regulations (40 CFR 156.10(j)(2)(i)), restricted use products must bear statements of restricted use classification at the top of the front panel. The Label Review Manual (Chapter 6. III.B.1) and PR Notice 93-1 both reflect this regulatory requirement that the statement must be at the very top of the label's front panel and also state that no other wording or symbols should appear above the RUP statement. This applies to all labels including section 3 supplemental and 24c Special Local Needs (SLN) labeling.
The Agency considers the use of "expert" such as in the name "Expert's Choice" to be potentially false or misleading because the term has no objective established meaning. "Expert" appears to refer to some individual or some sort of group of people, neither of which are further defined or identified. 40 CFR 156.10(b)(2) states that &#;No name, brand or trademark may appear on the label which: (I) Is false or misleading, &#;..&#; If pesticide labeling is false or misleading in any particular, the product is misbranded and it is a violation of FIFRA to sell or distribute a misbranded pesticide. See FIFRA 2(q)(1)(A); 12(a)(1)(E). Unless an applicant can prove otherwise to the Agency, for instance through consumer surveys, or can provide some objective meaning that is supported by evidence to "expert" on the label, the Agency considers the term &#;expert&#; (in any context) to be false and misleading.
40 CFR 156.10(c) requires that the name of the producer, registrants, or person for whom the product was produced be indicated on the label. Names of non-producers may be included if they are qualified by phrases such as "Packed for," "Distributed by," or "Sold by." More information is available in the Label Review Manual, Chapter 15. In the case presented in the question, the name and address of the registrant would be the foreign company. The US agent may be indicated if properly qualified. In addition, there would be no problem with the use of the US subsidiary's logo as long as it was not misleading or otherwise inconsistent with FIFRA or its implementing regulations.
40 CFR 156.10(b) requires the name, brand, or trademark under which a pesticide product is sold to appear on the front panel of the pesticide's label. It is acceptable for a product distributed under supplemental distribution (40 CFR 152.132), as distributor product, to use the same name as the "parent" product. That product name would be reflected on the supplemental distribution form. In the case of a purchase/merger of two companies, the original supplemental distribution registrations go away and new supplemental distribution registrations are created with the filing of new distributor forms.
If a company acquires a FIFRA section 3 registered product with the same name as one of their existing products, one of the two product names must be altered to some degree so that no two products of the registrant have the exact same name.
It has been the agency's policy not to allow the use of terms such as "total" or "complete" as part of product names because such use may be false or misleading. Use of terms such as "total" or "complete" may be allowed as part of a brand name so long as the brand name is presented in a non-misleading way. The Agency will work with registrants to fit potentially misleading brand names into the context of a label so that they are not misleading.
40 CFR 156.10(b) states that the name of a product must appear on the front panel of the label and it cannot be false or misleading. The name may be considered to be false or misleading unless it is sufficiently different to enable a user to distinguish one product from another and the exact same name cannot be used by any one registrant for different registered products. See Label Review Manual Chapter12. The Agency would consider the same name for two different products under the same company name to be misleading regardless of whether the registration numbers are different due to multiple company numbers. A similar question was previously answered, LC 08-.
Section 2(q)(1)(C) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) states that a product is misbranded if &#; it is an imitation of, or is offered for sale under the name of another pesticide.&#; Further, 40 CFR 156.10(b) states the names may not be false or misleading. We believe the best reading of the statute and regulations is that each product must have a unique name taking into account the name, brand or trademark in context. Thus, a company could not have two products with the same name but two different companies could potentially have a product with the same name because they would be distinguishable based on their company name. This interpretation stems from what is allowed under FIFRA and 40 CFR 156.10(b); it does not take into account any limitations on having the same name based on copyright or trademark laws.
Already-approved use sites and use directions can be incorporated onto an alternate brand name label without notification to the agency. Before any new use sites or new use directions can be incorporated on the alternate brand name label, they must first be approved and stamped accepted on the product&#;s master label.
An alternative brand name product label is an example of a &#;split label&#; (a label that bears claims and directions for only a portion of the approved uses under a given master label, but is a complete label in itself, containing all the required labeling elements). Agency regulations allow a registrant to distribute or sell a product under a &#;split label&#; provided that in limiting the uses identified on the label, no changes would be necessary to the precautionary statements, use classification, or packaging of the product as stated in 40 CFR § 152.130(b). Furthermore, since split labels only contain labeling text contained in the already approved master label, the split labels are not stamped &#;accepted&#; separately and don&#;t require notification.
40 CFR 156.10(c)(6 pp, 164 K, About PDF) requires that the name and address of producer, registrant, or person for whom produced be included on a pesticide's label. The requirement allows that the name appearing on the label can be qualified in several ways. For the example above, using XYZ Company would be acceptable. EPA does, however, need to be able to link the company names appearing on labels with company names appearing on registration documents. Therefore, EPA asks that companies change their registration documents to reflect the company names used on labels. See Chapter 15 of the Label Review Manual for more information.
40 CFR Part 156.10(c) addresses how the name and address of a producer must be represented on the label. The regulations are clear that an unqualified name and address is considered the name and address of the producer. If the producer is not the registrant and the name of the registrant appears on the label, the registrant's name and address must be qualified by terms such as &#;Packed for,&#; &#;Distributed by,&#; or &#;Sold by."The regulations are silent on whether the registrant could have the term &#;Produced For&#; or similar qualifier preceding their name and address on the label even when they are the producer of the product. Therefore, in a situation where the registrant is the producer of the product, the registrant&#;s name and address may appear either unqualified or qualified by an appropriate term such as &#;Distributed by&#; or "Produced for" so long as they qualification is not false or misleading. See FIFRA sec. 2(q)(1)(A)
The agency agrees that a zip code that is unique to a given registrant and adequate for the delivery of mail would meet the requirement of "address" as discussed in 40 CFR 156.10(a)(ii) and 40 CFR 152.50(b)(2).
In accordance with the regulations at 40 CFR 156.10(a)(ii) the label must show clearly and prominently the name and address of the producer, registrant or person for whom produced. 40 CFR 152.50(b)(2) also discusses an "address" requirement. That regulation states that a registrant must provide EPA with a current address that will be used by the Agency for corresponding with the registrant. It is also sufficient to provide company name, city, state, and a unique zip code where the zip code includes a PO box as part of the suffix.
Under Federal Law, only a federal registration is required to sell and distribute a pesticide. All states, under individual state laws, require that pesticides be registered in their state before they can be sold and distributed. The laws of the state where a sale or distribution occurs will determine who is responsible for any required state registration.
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.
According to 40 CFR 152.500(b)(1), devices are subject to the standards for misbranding under FIFRA § 2(q)(1) and the labeling requirements set forth in 40 CFR Part 156. Section 2(q)(1)(D) provides that a product is misbranded if &#;its label does not bear the registration number assigned under [section 7] to each establishment in which it was produced.&#; 40 CFR 156.10(f) states that the EPA establishment number may appear in &#;any suitable location on the label or the immediate container.&#; If the establishment number on the immediate container cannot be clearly read through an outer wrapper or container, then the establishment number must appear on the outer wrapper or container as well.
An EPA Establishment Number coded on a container, in the absence of any pesticidal claims by the product labeling or advertising, would not make the product subject to FIFRA in most circumstances. If the presence of an establishment number is intended to imply the product has pesticidal effect or if consumers are misled by the establishment number to believe the product has a pesticidal effect, the product may be subject to FIFRA. Note that pesticide device packaging must bear the EPA establishment number for the place where the device was produced, so some unregistered products that bear establishment numbers may be devices. Further, labeling for all products are subject to the requirements of the Federal Trade Commission, which can take action against false or misleading claims.
In the instance of an aerosol can filled at one establishment and packaged at a second establishment, the immediate container (the aerosol can) must bear the establishment number of the establishment where filled (Est. No. 1). The box that the aerosol can is placed in must bear the establishment number of the facility where the repackaging occurred (Est. No. 2). Both establishment numbers may appear because they can be easily associated with different steps in the packaging of the product. Please also note that if the full label of the aerosol can cannot be read through the outer package, the full label of the product must appear on the outer package.
40 CFR part 167 requires that all pesticides must be produced in an establishment registered with EPA. The definition of produce includes not only the manufacturing of pesticides but also packaging and repackaging of pesticides. If a pesticide container is placed in a blister card or box the packaging must take place in a registered establishment and the establishment number of the establishment appear on the package. If the packaging in the blister card or box takes place in a different establishment than where the original container was filled, the establishment numbers on the immediate container and the blister pack or box will be those of different establishments.
The blister card or box may list more than one establishment number as long as the correct establishment number where the last production step occurred is clearly visible on or through the outer container or wrapper and there is some designation to distinguish which establishment number applies. See 40 CFR 156.10(f). If the lot number is used to designate the appropriate establishment number, the label must explain how to interpret the lot number; i.e., &#;Letter at the end of the lot number designates the establishment number of the producing establishment. &#;T&#; = Tennessee, &#;O&#; = Ohio.&#; This statement should appear below the multiple establishment numbers. See also the Label Review Manual, Chapter 14(IV)(C).
Using a false EPA Establishment Number is considered misbranding as defined by section 2(q)(1)(A) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), which states that a pesticide is misbranded if &#;its labeling bears any statement...which is false or misleading in any particular.&#; Under Section 12(a)(1)(E) of FIFRA, the sale or distribution of any pesticide which is misbranded is unlawful. Violators may be assessed a civil penalty of up to $5,000 for each offense or a criminal penalty of up to $50,000 or 1 year imprisonment, or both, plus inflation adjustments provided by law.
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.
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.
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.
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.
In most cases, the misuse statement should not be included on the labeling of unregistered products being sold, imported or otherwise distributed in the U.S. because the statement would be false. The violation referred to in the misuse statement is a violation of section 12(a)(2)(G), which only prohibits misuse of registered products. Generally, it is not a violation of FIFRA section 12 to use an unregistered pesticide in a manner inconsistent with its labeling. Exceptions may exist based on an EPA order that imposes restrictions on the use of a particular unregistered product (e.g., a cancellation order that allows further use of the now unregistered pesticide), or as the result of an EPA regulation pursuant to FIFRA section 3(a).
If the misuse statement would be false as to a particular unregistered product, then including the statement on that product&#;s labeling would render it misbranded. Sales or distributions of misbranded pesticides that are not permitted by EPA order are violations of FIFRA section 12(a)(1)(E). Further, misbranded products generally cannot qualify for legal sale or distribution through the above-listed exceptions at section 152.30(a), (b), (c)(2) or (d), and therefore imports of such pesticides may be a violation of FIFRA section 12(a)(1)(A).
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:
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.
As described in the question, the pesticide within the bag is a liquid, suggesting that the net contents must be expressed in terms of liquid measure under 40 CFR 156.10(d)(2). Additionally, the bag is contained within a pressurized canister, suggesting that the net contents must be expressed in terms of weight under 40 CFR 156.10(d)(3). Because the pesticide is both liquid and pressurized, the net contents of BOV pesticide products must be expressed in terms of both liquid measure and weight.
"Mixers / loaders and applicators must wear a dust / mist filtering respirator meeting NIOSH standards of at least N-95, R-95 or P-95. Repeated exposures to high concentrations of microbial proteins can cause allergic sensitization."
Microorganisms are often strong sensitizers, and this precautionary label statement is required on microbial pesticides on a case-by-case basis to mitigate the potential risk of allergenicity from repeated inhalation exposure to airborne microbial particles.
This statement was first used during the Bt reregistration process. An earlier version of the statement was included in the Bt Reregistration Eligibility Decision document (RED). When the 40 CFR Part 158 data requirements for microbial pesticides were amended in , the preamble to the rule included a rationale for requiring the dust/mist filtering respirator (refer to The Federal Register, Vol. 72, No. 207, Friday, October 26, , page : &#;Notice, Pesticides: Data Requirements for Biochemical and Microbial Pesticides&#;). The Notice states, &#;The Agency expects that many microbial pesticides may be respiratory sensitizers, although there are no consistently reliable laboratory tests for this endpoint. Therefore, in general, the Agency requires protective equipment to lessen exposure to microbial agents for applicators with a high likelihood of repeated exposures.&#; Since then, when the Agency has had concern that a microbial pesticide may be a respiratory sensitizer and no information is available showing otherwise, the Agency has required the inclusion of a directions for use of a respirator to protect against sensitization when there is potential for inhalation exposure. Information showing a specific microbial pesticide is not a respiratory sensitizer would be considered and may lead EPA to determine this precautionary statement is not necessary for that specific pesticide.
All words, statements, graphic representations, designs or other information required on pesticide labeling must be set in no smaller than 6 point font. 40 CFR 156.10(a)(2). In addition, required content must appear on a clear contrasting background, not be obscured or crowded and be rendered so that it is likely to be read and understood by the ordinary individual under customary conditions of purchase or use. Precautionary statements must abide by the same 6-point font minimum, except when larger fonts are required for front panel precautionary statements such as signal words and child hazard warnings. 40 CFR 156.60(b) provides a table indicating the minimum required font size for front panel precautionary statements, which increases with the size of the label.
Yes. According to 40 CFR 156.68(d), first aid statements must appear on the front panel for all Toxicity Category I products, but the regulation allows for variation upon review if the proper reference statement is on the front panel. To request variation from the standard requirement, a registrant must explain to EPA why they believe it would be more practical for the information to appear elsewhere. EPA&#;s approval of the label with the variation is evidence of its acceptance.
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.. You are correct that the two endpoints (dermal irritant and dermal sensitization) correlate; and that is why the OPPTS 870. 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.
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:
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.
40 CFR 152.132(d) requires that labeling for the distributor product be the same as the registered primary product except for: product name, distributor name and address, registration number, establishment number, and deletion of specific claims (provided no other changes are necessary). It is not permissible to list a specific application rate on the distributor product labeling when the application rates on the registered primary product appear in a range. In order for a specific rate to be listed on the distributor product labeling, that one specific rate must appear on the registered primary product master labeling.
Spreader settings are not required to appear on the label of granular pesticide products. The label must include the application rate but calibrations/settings for specific brands of application equipment are not required, regardless of whether the product is for the general consumer or used by commercial applicators. Registrants may provide accurate information if they choose.
Section 12(a)(2)(G) of FIFRA states that &#;it shall be unlawful for any person to use any registered pesticide in a manner inconsistent with its labeling.&#; Use after the expiration date is inconsistent with the label directions and would be a violation regardless of the reason the date appears on the label.
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.
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.
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.
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 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)
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.
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.
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 (See PR notice -5). 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 -5 explains OPP's interpretation of terms such as "should", "may," and "must" as used on pesticide labels.
PR notice -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.
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.
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.
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.
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.
Yes. The phrase "unused product" should be interpreted as opened product containers as well as unopened containers.
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.
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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.
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.
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).
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.
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 -5 concerning advisory versus mandatory language. 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).
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.
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.
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.
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.
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.
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.
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."
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.
EPA generally would allow a registrant to voluntarily impose restrictions beyond what EPA has required where additional restrictions reduce risk. There may be cases where imposing additional restrictions would have no impact on the risks associated with use of a pesticide and, in those cases, additional restrictions may be considered misleading and therefore not allowed.
While EPA may allow additional restrictions, they must be presented in a way that does not mislead the user. For the scenario presented above, please note, that EPA would not allow both PHIs on the same registration. A change in PHI is a significant change to the use pattern of the product and so the PHI on the marketed label must match the PHI on the master label and registration. Further, having varying PHIs for the same use on one registration is potentially misleading. EPA allows marketing a subset of approved uses on labels that differ from the master label (often referred to as sub-labels or split labels) so long as no changes would be necessary to precautionary statements, use classifications or packaging. See the Label Review Manual, Chapter 3, Section IV for more information. EPA would not approve a master label containing two conflicting PHIs, and because sub- or split labels are pulled directly from the master label, a registrant would not be able to create a sub- or split label with a different PHI for the same use.
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, .
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 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.
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.
There are no standard alternative "Container Disposal" statements specific to antifouling paint products. If the products in question are not intended to be diluted before use, EPA does not require rinsing instructions on the label (See EPA's August Pesticide Container-Containment Rule, 40 CFR 156.140 - 156.159 and the FAQ for more details.) EPA agrees that it may not be prudent to triple rinse containers that hold pesticides that are ready-to-use products. In those cases, the rinsate cannot be incorporated into the pesticide application because there is no pesticide mixture. Therefore, rinsing the container would require the end user to properly dispose of the rinsate in addition to properly disposing of or recycling the container. Accordingly, §156.146 and §156.156 of the container-containment rule require detailed rinsing instructions only for dilutable pesticide products' containers.
For dilutable products that cannot be effectively rinsed with water, §156.146(d) also allows registrants to propose alternative rinsing instructions. Likewise, PR Notice 83-3 also provided that registrants might propose alternative container disposal statements if the statements recommended in the PR Notice and Chapter 13 of the Label Review Manual were not appropriate. Registrants may revise the container disposal statement for a specific product by submitting an amendment to EPA with the revised container disposal instruction.
Please note that there may be additional residue removal requirements under the Resource Conservation and Recovery Act (RCRA) regulations if the product is classified as a RCRA hazardous waste when it is disposed of.
No. 40 CFR 156.10(i)(2)(ix) requires the heading "Storage and Disposal," which must be set in the type of the same minimum sizes as required for the child hazard warning. In addition, subsequent PR Notices, like 84-1 and -6, came out to clarify Storage & Disposal guidance for residential use &#; household use products.
The best method for using up opened and unused pesticides or unused diluted spray is use according to label directions. Oftentimes, the unused product or diluted spray can be applied to another site listed on the label. The Agency does not recommend pesticide disposal in the trash or by burying. See additional guidance on pesticide disposal.
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 ()].
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 PR Notice 94-2 (May 16, )] This requirement predates [See 36 Fed.Reg. (Nov. 25, ), 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 which dramatically amended FIFRA, as well as the federal regulatory program for hazardous wastes, the Resource Conservation and Recovery Act of . 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:
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.
There are no standard alternative "Container Disposal" statements specific to antifouling paint products. If the products in question are not intended to be diluted before use, EPA does not require rinsing instructions on the label (See EPA's August Pesticide Container-Containment Rule, 40 CFR 156.140 - 156.159 and the FAQ for more details.) EPA agrees that it may not be prudent to triple rinse containers that hold pesticides that are ready-to-use products. In those cases, the rinsate cannot be incorporated into the pesticide application because there is no pesticide mixture. Therefore, rinsing the container would require the end user to properly dispose of the rinsate in addition to properly disposing of or recycling the container. Accordingly, §156.146 and §156.156 of the container-containment rule require detailed rinsing instructions only for dilutable pesticide products' containers.
For dilutable products that cannot be effectively rinsed with water, §156.146(d) also allows registrants to propose alternative rinsing instructions. Likewise, PR Notice 83-3 also provided that registrants might propose alternative container disposal statements if the statements recommended in the PR Notice and Chapter 13 of the Label Review Manual were not appropriate. Registrants may revise the container disposal statement for a specific product by submitting an amendment to EPA with the revised container disposal instruction.
Please note that there may be additional residue removal requirements under the Resource Conservation and Recovery Act (RCRA) regulations if the product is classified as a RCRA hazardous waste when it is disposed of.
FIFRA, for the most part, regulates sale and distribution of pesticides in commerce. FIFRA's reach to pesticide users is primarily focused on requiring users to follow pesticide labels and other instructions related to use. See e.g., FIFRA 12(a)(2)(G). Relabeling pesticides for sale and distribution is considered a production activity under 40 CFR 167.3 and must occur in an EPA registered establishment. But, an end-user who restores a pesticide label solely for his own use and not for sale or distribution would not be engaging in production of a pesticide that is subject to the requirements of 40 CFR Part 167. So long as the end user is only replacing a damaged label with an intact label that is exactly the same as the original label and that fully conforms to the EPA-approved label, the end user is neither altering nor defacing the label in violation of FIFRA section 12(a)(2)(A). For the situation posed in this question, the manufacturer may provide a replacement label and the end-user may attach that label over the damaged label so long as the label provided is identical to the damaged label and the product will not be sold and distributed beyond the end-user.
Note that shipment of a pesticide with a damaged label may be a violation of FIFRA 12(a)(1)(E) because the damage to the label may make the pesticide misbranded. Shippers should take all steps possible to ensure the safe handling and shipment of pesticide products so that the labeling remains intact.
When a product makes a claim that it disinfects, it is making a pesticidal claim and must be registered by EPA to be legally sold and distributed in the United States. 40 CFR 156.10(a)(1)(iv) requires the EPA registration number to appear on a pesticide's label. The label consists of the "written, printed, or graphic matter on, or attached to, the pesticide or device or any of its containers or wrappers." FIFRA 2(p)(1). Generally, supporting product literature such as technical data sheets are considered labeling, which FIFRA 2(p)(2) defines, 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&#;&#; In most cases where all labeling requirements are fulfilled by the label, EPA does not require any accompanying materials or what content needs to be in them should they exist. When accompanying or referenced materials do exist: 1) they are subject to review and approval; 2) may not be false or misleading; and 3) may not contain any claims that substantially differ from those that are approved for the registration.
EPA recommends that any associated materials contain the product name and product registration number so that the user can relate that material back to the product label.
A booklet that contains information required by 40 CFR Part 156 to be part of the product labeling must either accompany the product or be referenced on the label or in literature accompanying the pesticide. See FIFRA 2(p)(2). If the booklet is not referenced on the container label or accompanying literature, the booklet must accompany the product at the time of sale and may be distributed to dealers by attaching it to the shipping papers so long as there are an equal number of booklets and containers so that a booklet accompanies each container that is sold. If the labeling information is referenced on the container it need not be provided in equal numbers so long as the user can obtain the information in some format.
"Label" is defined by section 2(p) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) as &#;&#;the written, printed, or graphic matter on, or attached to, the pesticide or device or any of its containers or wrappers.&#; Labeling is defined by section 2(p) of FIFRA as "all labels and all other written, printed, or graphic matter accompanying the pesticide or device at any time; or to which reference is made on the label or in literature accompanying the pesticide or device..." Therefore, information attached to a pesticide product by a rubber band or other means is considered labeling and is subject to the labeling requirements in 40 CFR Part 156. However, certain information required in Part 156 must be contained on the actual product label versus on attached or unattached labeling. The label must be "securely attached" to the product and EPA would not consider attaching paper with a rubber band to be securely attached.
A Quick Response (QR) code that allows easy access to websites or other text from portable devices can be added to a pesticide label. With some listed exceptions for official government publications, written, printed or graphic matter that is referenced on a pesticide label is considered &#;labeling&#; as defined in FIFRA § 2(p)(1)(2). Therefore, if a QR code is added to a label, the content it references is considered labeling and is subject to review by the Agency.
If a URL to a web page is already on the label, then the addition of a QR code that takes customers directly to the same web page can be done through notification per PR Notice 98-10 Section II. H, which allows the use of graphics in conjunction with approved text to be added through notification. If the URL is not already present on the approved labeling, the QR code needs to be added by an amendment.
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.
The Globally Harmonized System of Classification and Labeling of Chemicals (GHS) is a internationally agreed-upon system for classifying and labeling chemicals in a consistent manner. The GHS does not itself impose any labeling requirements on products in the United States, but the United States has revised some U.S. labeling systems, such as OSHA&#;s Hazard Communication Standard, to incorporate the GHS. As explained in PR Notice -1, pesticide labels approved by EPA pre-empt OSHA&#;s labeling requirements in their Hazard Communication Standard.
A combination product that contains a pesticide and a fertilizer is regulated as a pesticide product under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), and must bear labeling that meets FIFRA requirements for the whole product. EPA has not incorporated the GHS into its FIFRA labeling requirements and the pesticide product must be labeled in accordance with 40 CFR Part 156 for all components of the product.
Note that pesticide products may still be subject to the OSHA requirement to develop a Safety Data Sheet (SDS) based on the GHS. PR Notice -1 explains how to address inconsistencies between GHS and FIFRA precautionary language in SDSs that accompany pesticides.
There is limited guidance available at this time regarding the use of fragrances in pesticides. In December , EPA published guidance for registrants seeking to add new or modify existing fragrances by the notification process. The guidance indicates the requirements necessary to qualify under this program. InertFinder includes the latest Fragrance Ingredient List. Although this document is posted on the AD web site, it is guidance applicable to all three regulatory divisions, AD, BPPD and RD. If you need guidance in that area, you should contact the appropriate PM team.
Certification from the Organic Materials Review Institute (OMRI) is not germane to whether a pesticide product requires registration. All pesticide products require registration unless they are explicitly exempted from registration under FIFRA, such as in the case of minimum risk pesticides exempted under FIFRA 25(b) (40 CFR Part 152.25(f)). Neem Oil is not an exempt active ingredient under 152.25(f), and is currently registered with the Agency in many pesticide products. OMRI certification is only relevant to Agency consideration when a registrant seeks to make an organic label claim on a registered pesticide product. In that case, a registrant seeking to make an OMRI claim can follow the procedures in Pesticide Registration (PR) Notice -1 (Labeling of Pesticide Products under the National Organic Program).
No. FIFRA labels approved by EPA pre-empt OSHA&#;s label requirements, so the OSHA rule does not require registrants to amend their FIFRA labels. However, OSHA&#;s rule will require manufacturers to update their SDSs and where SDSs accompany pesticides they are considered labeling under FIFRA. EPA has issued guidance on how registrants can ensure that their updated SDSs are not inconsistent with their approved FIFRA labeling in PR Notice -1.
40 CFR 167.20(a)(1) requires that any establishment where a pesticidal product is produced be registered with EPA. A pesticidal product is defined as &#;a pesticide, active ingredient, or device.&#; 40 CFR 167.3. The act of applying a pesticide label to an empty container, for the purposes of sending it to another location for filling, does not constitute production of a pesticidal product because there is no pesticide, active ingredient or device involved. Therefore labeling an empty container as described does not have to be done in a registered establishment. In contrast, applying a label to a container that has been filled with a pesticide is considered production and must be done in a registered establishment. Also note, that empty pesticide containers may be subject to other FIFRA requirements under some circumstances, such as, distribution of used pesticide containers that contain pesticide residues or where the prospective buyers expect to receive full containers.
40 CFR 156.10(a)(4) requires that the label appear on or be securely attached to the immediate container of the pesticide product so that it can reasonably be expected to remain affixed to the pesticide's immediate container during the foreseeable conditions and period of use. For products such as bait stations, the immediate container of the pesticide product is considered by the Agency to be the bait station itself because EPA expects the outer container holding the individual bait station(s) prior to use to likely be disposed of once the bait stations have been removed from the outer container to then be put out for use. 40 CFR 156.140 requires certain statements, including a batch code, be placed on the label or container. Therefore, the batch code would need to go on the bait station which would in this instance be the immediate container, either directly on the bait station or on a label that is attached securely to the bait station, rather than on a secondary outer container that would likely be discarded before the actual bait station is used or during its use. The intent of the batch code requirement is to allow for the tracing of defective products back to the place of manufacture, and identification of other products manufactured as part of the same batch.
All pesticides sold in the U.S. must be produced in an establishment that is registered with EPA. The pesticide producing establishment must appear on the container of the pesticide. The pesticide producing establishment number is the company number of the producing establishment, followed by the code of the state or country where the establishment is located, followed by the number of the establishment located in that state or country. As an example, for the establishment number -NY-02, is the company number of the establishment, NY indicates that the establishment is located in New York state, and 02 indicates that the establishment is the second establishment of that company registered in New York state. Pesticides that are produced in the U.S. bear a 2-letter state code and foreign establishments bear a 3-letter country code. Foreign country codes may be found at the Enforcement website.
The establishment number on a product is the number of the last establishment where production activity took place. Production activity may have occurred in several previous establishments. Beyond the requirement to include the last establishment, EPA has no requirement to list the country of origin on pesticide labeling.
Pesticide groups such as Group 4A refer to resistance management of target pests. Each group identity is based on the mode or target site of action of the pesticide on the pest. Herbicides, fungicides, bactericides, insecticides, and acaricides are separately grouped by various technical/research committees consisting of researchers, university extension specialists, regulatory officials and the pesticide industry. EPA based its mode/target site of action groupings for pesticide labeling on those previously defined by the following industry technical committees: Herbicide Resistance Action Committee (HRAC), Fungicide Resistance Action Committee (FRAC), and Insecticide Resistance Action Committee (IRAC). Information on each of these organizations, the mode/target site of action groups, and recommended resistance management strategies may be found via Web search.
Pesticide companies are not required to include resistance management labeling and mode-of-action (group) identification on their product labels, however, they are strongly encouraged to do so. EPA's Office of Pesticide Program's Resistance Management Work Group is currently working on updating the website regarding this effort.
More detailed information on pesticide resistance management labeling guidelines may be found on EPA's web site.
According to 40 CFR 156.10(d)(2), The net contents of liquid formulations must be expressed in terms of liquid measure at 68º F(20º C): gallons, quarts, pints or fluid ounces. However, the CFR does not restrict additional information about the net contents other than providing that the net contents may also be stated in metric units in addition to the required units specified. Therefore, it would be permissible to include both volume and weight so long as it is not done in a false or misleading manner.
According to 40 CFR 156.10(a)(3), where non-English text is required by the Agency to be included in labeling, all the requirements that apply to English apply equally to the non-English text. The Agency also allows other languages to optionally be included in labeling if they are true and accurate translations of the English. See PR-N 98-10. When non-English text is included optionally, there are no requirements on how it is presented, but EPA recommends that it be no smaller than 6-point type to allow legibility.
EPA does not generally review MSDSs and they need not be approved by EPA before being distributed. If, however, the MSDS accompanies the pesticide at any time, it is considered labeling and must not conflict with the labeling EPA has approved for the pesticide product. If there is a conflict between the EPA-approved labeling and the MSDS, the pesticide product may be misbranded. For example, if a product has different mandatory PPE requirements on its label and its MSDS, the product may be misbranded. If the approved labeling indicates mandatory PPE requirements and the MSDS recommends more protective PPE, EPA may determine that there is no conflict. Generally, however, the PPE requirements on a product's label must be followed and overrule any differing requirements that may appear on an MSDS. If you have a case such as this, please inform the Agency and we will investigate whether corrections are necessary.
Net weight or contents must be stated on a pesticide label in accordance with FIFRA (2)(q)(2)(C)(iii) and 40 CFR 156.10(a)(1)(iii). EPA interpretation of the statutory and regulatory requirements is that the label must state the total weight for the entire contents as sold and distributed. In addition, the label may indicate the net weight and quantity of individual units within the carton. For example, "Net Weight 6.25 lbs. (20 - 5oz. packets)." For additional information regarding the Net Weight/Contents statement, please reference Chapter 17 of the Label Review Manual.
Whether EPA can require labeling language about state, local or tribal restrictions depends upon specific facts related to individual products and the applicable bans. But generally, EPA believes FIFRA provides the authority to require such statements.
The regulations concerning the labeling of pesticides for export (40 CFR 168.65) need to be consulted. The regulations do not require a &#;country of origin&#; statement. The regulation includes a requirement that &#;The name and address of the producer, registrant (if any) or the person for whom the pesticide was produced, must appear on the label.&#; In addition, the label must include, among other things, the EPA pesticide producing establishment number, appropriate warning or caution statements, the ingredient statement, and the net weight. Warning and caution statements, including the word &#;Poison&#; where necessary, and the ingredient statement must appear in English, in an acceptable language of the country of import and in an acceptable language of the country of final destination if known or reasonably ascertainable. 40 CFR 168.65(b)(4). In order for the pesticide to be treated as registered for purposes of FIFRA section 17(a)(1), among other requirements, the label and labeling approved under a current FIFRA section 3 registration must be attached to the immediate product container or accompany the product at all times. 40 CFR 168.65(b)(1)(iii)(A)(1).
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).
The hazard communications requirements of OSHA found at 29 CFR . include requirements for labeling and the provision of an MSDS as specified in the regulation. 29 CFR .(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 .(g). See 29 CFR .(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.
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.
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. 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].&#;&#;
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.
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.
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, states that advisory statements can be deleted by notification. Is this still the case? (LC08-; 5/15/08)PR Notice -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, -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.
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, Standards for Containers and Containment Final Rule (71 FR ) for more information on requirements for these activities.
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).
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.
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 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.
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.
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.
The general rule that the Agency uses in addressing use of previously approved labeling can be found in 40 CFR 152.130 (2 pp, 121 K, About PDF). 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.
The only Web page 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.
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.
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.
After a label has been approved, misspelled words may be corrected without notifying EPA. According to PR 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."
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.
Normally, it would be a violation of FIFRA to break up a registered pesticide product and sell and distribute individual doses. However, on November 1, , EPA published a notice of an enforcement policy in the Federal Register entitled &#;Pesticide Use and Production by Veterinarians; Statement of Policy on the Applicability of the Federal Insecticide, Fungicide, and Rodenticide Act to Veterinarians&#; (44 FR ). This policy provides that veterinarians may dispense pesticides for treatment provided certain minimal conditions described in the notice are met. The conditions are paraphrased below, for full details see the policy statement:
Provided the conditions listed in the notice are met, a veterinarian may break up a 3- or 6-pack and sell individual doses. Further, EPA urges veterinarians to discuss the labeling directions with the client at the time the pesticide is dispensed.
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.
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:
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.
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.
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.
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.
PR Notice 98-10 discusses what labeling changes may be accomplished through notification or non-notification pursuant to 40 CFR 152.46. Generally, reformatting of labeling can be done through non-notification. Section IV.E includes the following about redesigning labels through non-notification: "A label format change that does not modify approved label text and is consistent with the format requirements of 40 CFR 156.10 and Agency policy. These may include, among other things, changes in color, type size or style, use of space, configuration or placement of label elements." But the change you describe -- changing the reference statement to point users to a booklet rather than a side panel -- changes approved label text and therefore is not a redesign of the label format that may be accomplished through non-notification. Because the Agency has not provided elsewhere that this change may be accomplished through notification, it must be submitted as an amendment to registration under 40 CFR 152.44.
Storage temperature is not a data requirement generally imposed by the Agency, however, a manufacturer may include specific storage instructions which are developed on an individual basis to ensure the efficacy of the product. For example, certain microbial products may simply state "refrigerate," while others (if necessary) will list a specific temperature range at which the product should be stored. There is no standard because each microbial is unique and presents different storage issues.
When storage instructions, such as a specific storage temperature, are included on a pesticide label, they are considered part of the directions for use. According to Pesticide Registration (PR) Notice 98-10, Notification, Non-Notifications and Minor Formulation Amendments, only limited changes to the directions for use may be made by notification (see section II.M.). Other changes to the directions for use including changes to storage and disposal directions may not be made though the notification process (see section II.N.3). Therefore, a label change to reflect a change in the storage temperature (physical/chemical property) of a product must be submitted as an amendment.
If the storage temperature is not specifically mentioned on the label and instead only appears on the MSDS, it may be changed on the MSDS without amendment or notification. EPA considers an MSDS to be labeling when it accompanies a pesticide product, but EPA does not review or approve the MSDS. The MSDS must, however, not conflict with the labeling EPA has approved for the pesticide product as that could make the pesticide product misbranded
IRAC and FRAC classifications refer to mode or target site of action groupings used in pesticide resistance management advisory statements. See PR Notice -5Search EPA Archive 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 -5 or registrants use similar wording based on the attributes described in section VI of PR Notice -5.
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.
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 -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.
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 -5 does not supersede PR notice 98-10 in total. PR notice -5 does affect one portion of PR 98-10: registrants may no longer add or change advisory labeling statements by Notification.
The statements &#;Not for Use in XXXX (insert state)&#; and &#;Not for Use in XXXX (insert counties and state)&#; do not fall under PR Notice 98-10, as a notification because they are changes in the directions for use. Therefore, such statements should be submitted as an amendment. However, if the language is revised to read &#;Not Registered for Use By (insert state)&#;, &#;Not Registered for Use on XXXX (insert commodity) by XXXX (insert state)&#; or &#;Not Registered for Use by XXXX (insert state) For Use in XXXX Counties&#; it may be added to the label via non-notification since it is not a restriction and is a state driven statement.
Under 40 CFR 152.132(d), the label of a distributor product must be the same as the label of the registered product with the following exceptions. If a distributor wishes to make a change to the distributor label, they may do so if the change is covered by one of the listed exceptions in 152.132(d). If the change isn&#;t covered by the listed exceptions in 152.132(d), then the distributor should work with the registrant to make the change to both the master label and the distributor label. If the change meets the criteria for being made via non-notification under PR Notice 98-10, then the registrant and the supplemental distributor may make the change. However, the distributor cannot make the change on the distributor label until after the registrant has done so on the master label, as PR Notice 98-10 provides that &#;a registrant may accomplish the following types of actions without notification to the Agency&#; (page 11, emphasis added). Note that this does not mean that the change must be on a stamped master label uploaded onto PPLS, since the registrant may add the change to the master label via non-notification, meaning that EPA would neither review nor approve the change. EPA recommends that supplemental distributors keep track of the changes the basic registrant has made. Basic registrants own the source registration known as the 'Section 3 registration' and other registrants may have agreements to distribute these products under their own 'supplemental' labeling. Also, keep in mind that 152.132 provides that a distributor is &#;considered an agent of the registrant for all intents and purposes&#; under FIFRA, and that &#;both the registrant and the distributor may be held liable for violations pertaining to the distributor product.&#;
If a change meets the criteria for being added via non-notification under PR Notice 98-10, the Agency encourages its addition via non-notification rather than notifications and/or amendments, due to limited Agency resources to handle unnecessary submissions. The following are examples of items that may be changed/added to the label via non-notification in accordance with PR Notice 98-10: 1) label format changes; 2) lot or batch codes, barcodes or other production identifiers; 3) fixing minor typographical errors; 4) changes in package sizes; and 5) changes of address.
156.10 (1)(a)(4)(i) says, &#;&#;If the immediate container [of the pesticide] is enclosed within a wrapper or outside container through which the label cannot be clearly read, the label must also be securely attached to such outside wrapper or container, if it is a part of the package as customarily distributed or sold.&#; In the situation described in the question, the pesticide is not customarily sold in the shipping carrier of the common carrier. Therefore the label does not need to appear on the common carrier&#;s shipping container.
40 CFR 156.10(a)(4) requires that the label appear on or be securely attached to the immediate container of the pesticide product. If the immediate container is enclosed within a wrapper or outside container through which the label cannot be clearly read, the label must also be securely attached to such outside wrapper or container, if it is a part of the package as customarily distributed or sold. While marketing claims and other non-mandatory language (e.g. a warranty statement) generally must be approved by EPA before being included on a label, a registrant may choose where and when to include them so long as their presence or absence does not cause the label to be false or misleading or otherwise misbranded as defined in FIFRA sec. 2(q). In short, these non-mandatory label elements do not have to be duplicated on the tray.
Selling and distributing a pesticide in package sizes that have not been approved by EPA or with labeling that does not conform with the EPA-accepted labeling may be a violation of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Violations of FIFRA can lead to civil or criminal penalties. For more detail, see EPA's FIFRA Enforcement Response Policy.
There are a number of ways a company may repackage a registrant's product. A company may enter into a supplemental distribution agreement with the registrant to sell or distribute the registrant's product according to the conditions found in 40 CFR § 152.132. The distributor product would bear the supplemental registrant's company name with the appropriate qualifiers (see 40 CFR § 156.10(c)).
A second alternative would be for the registrant to amend their registration by adding an alternate brand and container size for the product your company wishes to sell if they do not already sell the product in that container size. Again, the label could bear your company's name and address with the appropriate qualifiers as described in 40 CFR § 156.10(c).
The third alternative would be for your company to register your own product as a 100% repack of the first registrant's product. If you choose that option contact the ombudsperson of the relevant registering division in OPP for more information on the process for registering a pesticide as a 100% repack.
A pesticide product label must appear on or be securely attached to the immediate pesticide product in accordance with 40 CFR 156.10(a)(4) and, if the product has an outer container through which the label cannot be clearly read, the label must also be securely attached to the outer container. 40 CFR 156.10(a) lists the contents of a pesticide label. Each piece of information listed in 40 CFR 156.10(a) must appear on the label unless there is a specific provision allowing it to appear elsewhere. For example, 40 CFR 156.10(i)(1)(ii) allows the directions for use to "appear on printed or graphic matter which accompanies the pesticide provided that: (A) If required by the Agency, such printed or graphic matter is securely attached to each package of the pesticide, or placed within the outside wrapper or bag; (B) The label bears a reference to the directions for use in accompanying leaflets or circulars, such as 'See directions in the enclosed circular;' and (C) The Administrator determines that it is not necessary for such directions to appear on the label."
Certain label elements must appear on the front panel, for example, the signal word and child hazard warning in accordance with 40 CFR 156.60(a). But including just the items required to be on the front panel on the outer container may not be sufficient. For example, in some cases, the first aid statement may not be required on the front panel. See 40 CFR 156.68(d). But the first aid statement must always appear on the label as opposed to solely on an insert.
There is no maximum lifetime (specified number of years) for refillable containers in EPA's pesticide container regulations. Under EPA's regulations, refillable containers can be used as long as they continue to pass the visual inspection required before each refill by EPA's regulations (40 CFR 165.70(f)) and any leakproofness test and periodic inspections specified in the Department of Transportation (DOT) requirements that EPA incorporated into the refillable container regulations in 40 CFR 165.45(a) & (b). In addition, refillers should look carefully at their repackaging contracts with the pesticide registrants because those contracts may specify maximum life spans for certain types of containers.
40 CFR 156.10(a)(4)(i) states that: &#;The label shall appear on or be securely attached to the immediate container of the pesticide product.&#; The regulations go on further to state: &#;If the immediate container is enclosed within a wrapper or outside container through which the label cannot be clearly read, the label must also be securely attached to such outside wrapper or container, if it is a part of the package as customarily distributed or sold.&#;
If the pesticide product is customarily removed from the shipping container prior to being distributed or sold to the end user, the shipping container does not have to bear the full product label. If the shipping container is the unit which is customarily distributed or sold to the user the shipping container must bear the full product label. While the regulations do not require specific labeling for shipping containers, the Agency recommends that the shipping container be labeled with enough information for emergency personnel to be able to identify the material in the shipping container in the event of an accident or spill. Be advised that DOT may require labeling of the shipping container depending on the characteristics of the material being shipped.
Individual items in a place-pack-style product may bear the full label or an abbreviated label.
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.
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.
There is no specific list of approved inks for water soluble packaging (WSP). A listing of inert ingredients permitted for use in nonfood use pesticide products is available. 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 .
PR Notice -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.
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.
The Agency considers carrier materials such as the towelettes, or the plastic in a wristband to be part of the pesticide product. In the case of a registered antimicrobial towelette for example, the Agency considers the pesticide product to be the combination of the towelette and the liquid, not just the liquid that is contained within the towelette.
40 CFR 152.3 defines "inert ingredient" to mean "any substance...other than an active ingredient, which is intentionally included in the pesticide product." Since the carrier material is not the pesticidally active component of the product but it is intentionally included in the product, it is an inert ingredient. 40 CFR 152.25(f)(3)(ii) states that " Each product containing the substance must bear a label identifying the name and percentage (by weight) of each active ingredient and the name of each inert ingredient." Furthermore, 40 CFR 152.25(f)(2) states, "A pesticide product exempt under paragraph (f)(1) of this section may only include inert ingredients listed in the most current List 4A." It is on those bases that for a § 152.25(f) product, all inert ingredient(s) in the product must be acceptable under the 25(b) exemption and be listed on the product label.
"Inert Ingredients Approved for Use in FIFRA 25(b) Pesticide Products" lists the inert ingredients that are eligible for inclusion in pesticide products under the FIFRA section 25(b). This listing of minimal risk inert ingredients updates what has been historically referred to as "4A" under PR Notice -6.
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 our website on minimum-risk pesticides for more information.
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 -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(3 pp, 149 K, About PDF) conditions for minimum risk exemption.
The Agency reviews graphics on pesticide labeling on a case-by-case basis. Graphics or symbols may not be false or misleading. See FIFRA § 2(q)(a)(1) and 40 CFR § 156.10(a)(5). In some cases, it may be acceptable to use a picture of a plant or fruit on a label to indicate the fragrance of a pesticide product. However, if the product did not contain the fragrance depicted by the graphic, it would likely be misleading. For antimicrobial products, the use of graphics depicting fruit on an antimicrobial label is further addressed in a letter to the Consumer Specialty Products Association (CSPA).Search EPA Archive This letter describes a number of questions a company should address in determining whether the use of certain food or food-like fragrances and/or graphics on an antimicrobial label could make the product attractive to children. Increased potential for accidental ingestion or other exposure due to heightened product attractiveness to children could impact whether a product could pose a risk of unreasonable adverse effects on man or the environment, and therefore whether it can be registered.
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". 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. 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 -1 and the Label Review Manual, Chapter 12.IV.
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. The Agency will not accept use of such slogans/logos on labels or labeling without sufficient supporting documentation showing the slogan/logo is neither:
With respect to ingredient disclosure, formatting requirements are found at 40 CFR 156.10 (g) (1) and (2).
As long as the Microsoft table format meets these requirements it would be permissible.
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.
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.
The repackaging of a pesticide is considered production and must take place in a registered establishment. The registrant and the second company could enter into a contract manufacturing agreement in order to repackage the product. The second company would have to register the establishment where the repackaging takes place and submit an annual report on all the pesticide production activities that take place at that establishment as required by 40 CFR Part 167. The second company would not be considered a supplemental distributor if all it did was repackage the pesticide as directed by the registrant. If the second company wished to sell or distribute the pesticide under its own name they could then approach the registrant to become a supplemental distributor of the product in accordance with 40 CFR 152.132.
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.
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).
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.
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.
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.
FIFRA sec. 2(u)(2) defines &#;pesticide&#; to include &#;any substance or mixture of substances intended for use as a plant regulator.&#; &#;Plant regulator&#; is defined, in part, in FIFRA sec. 2(v) as &#;any substance or mixture of substances intended, through physiological action, for accelerating or retarding the rate of growth or rate of maturation, of for otherwise altering the behavior of plants or the produce thereof.&#; The definition explicitly excludes &#;plant nutrients, trace elements, nutritional chemicals, plant inoculants and soil amendments.&#; EPA has interpreted the definition of &#;plant regulator&#; further in 40 CFR 152.6(f) and (g), which excludes two specific categories of products as described in the regulation, namely vitamin hormone products and products intended to aid the growth of plants, from the definition of &#;plant regulator,&#; and therefore from regulation under FIFRA.
Biostimulants are not specifically addressed in FIFRA or in EPA&#;s regulations. As generally understood, biostimulants are mixtures that are likely to contain plant hormones. EPA considers plant hormones, such as cytokinins, gibberellins, ethylene, abscisic acid and auxins, to be plant regulators and thus must be registered as pesticides. If a product contains a plant hormone intended for use as a plant regulator, it must be registered, even if that plant hormone is naturally occurring and/or part of a biostimulant.
&#;Vitamin hormone products&#; are an exception to the requirement of registration for plant hormones. Vitamin hormone product are mixtures that may contain plant hormones, but EPA has determined that vitamin hormone products are excluded from regulation under FIFRA when they meet the criteria listed in 40 CFR 152.6(f), i.e. that they are not intended for food crops and labeled accordingly, and that they are toxicity category III or IV in the undiluted form they are sold and distributed.
A registrant may correct labels by adding stickers. Adding a sticker to the label is considered relabeling and therefore production. The sticker must be applied in a registered establishment, the relabeling must be reported, and the sticker may only obscure the information it is replacing. If information is being added by a sticker, the sticker must not contradict labeling already on the container, must be firmly attached to the label and may not obscure information required to be on the labeling. Generally changes to labeling must be made through an amendment to the registration. However, Pesticide Registration (PR) Notice 98-10 and some subsequent PR Notices provide types of changes that may be made simply by first notifying the Agency of the registrant&#;s intention and what changes may be made through non-notification.
The Office of Pesticide Programs does not generally review labels of products that are exempt from FIFRA registration and has no specific requirements or guidance on how they should be formatted. For some exempt products, certain information must be included on the label to meet the exemption. For example, 40 CFR 152.6(f)(2) requires that exempt vitamin hormone product labels not be intended for use on food crop sites and that they be labeled accordingly. This might be accomplished by explicitly stating the product is not for use on food crop sites or by stating that it is only for use on listed non-food sites. There are no other requirements for what must be on an exempt vitamin hormone product label to meet the exemption and EPA's other labeling requirements for registered pesticides do not apply.
Please note, however, that including label language that is inconsistent with the criteria for meeting an exemption may call into question whether the product is truly exempt from registration requirements. Further, false or misleading claims may be subject to enforcement by the Federal Trade Commission. This answer addresses labeling for vitamin hormone products, see 40 CFR 152.6(f) for the complete criteria that must be met for a vitamin hormone product to qualify for exclusion from FIFRA.
A sample that is intended for nonpesticidal testing is not subject to the labeling provisions of FIFRA but is subject to any applicable DOT shipping requirements. The language proposed in your question may appear on the sample.
A sample that is intended for pesticidal testing (e.g., testing for pesticidal activity or efficacy) must be labeled in accordance with FIFRA and may not bear the language proposed in your question unless the registration is amended to reflect the new labeling for samples.
Products, such as traps and lures, that (1) do not contain toxicants; (2) are intended only to attract pests for survey and detection purposes, and (3) are labeled accordingly (i.e., no pesticidal claims are made on labeling or in connection with sale or distribution of the product), are not considered to be pesticides by the Agency because they are not intended for a pesticidal purpose (see 40 CFR § 152.10(b)). Therefore, these products are not subject to any FIFRA requirements.
Further, pheromone traps and lures that are intended for a pesticidal purpose are exempt from the FIFRA registration requirement pursuant to 40 CFR § 152.25(b). However, such products remain subject to other FIFRA provisions, such as labeling requirements.
EPA and FDA have never jointly approved such a product. Pesticides such as disinfectants are regulated under the authority of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) while drugs such as topical antiseptics are regulated under the authority of the Federal Food, Drug and Cosmetic Act (FFDCA). Both EPA and FDA each have their own regulations they use to regulate products subject to their respective jurisdictions. These regulations set out procedures, data and labeling requirements as well as criteria that are exclusive to specific claims and use patterns. Regulations for pesticide products are substantially different from those in place and used to regulate drugs. In general, the labeling requirements for a pesticide are significantly different from those required for a drug. Further, having directions for both pesticidal and drug use on the same product may create concerns over the proper use of the product that would not allow it to be registered by EPA. Given the difficulties involved with a joint approval, EPA encourages applicants to separate pesticide uses to a separate product.
If the substance being imported is a pesticide, a Notice of Arrival (NOA) must be submitted. See FIFRA § 17(c). See more information on NOAs.
Some substances can be both pesticides and non-pesticides. To determine whether a substance is a pesticide and therefore subject to FIFRA, one must determine if the substance is &#;intended for a pesticidal purpose, i.e., use for the purpose of preventing, destroying, repelling, or mitigating any pest&#;&#; 40 CFR § 152.15. EPA considers a substance to be intended for a pesticidal purpose if:
If the substance being imported is a pesticide, a Notice of Arrival (NOA) must be submitted. See FIFRA § 17(c). Read more information on NOAs.
A pesticide being imported for research and development may need to be registered depending on how it is being sold or distributed. If the pesticide is registered, an importer can sell and distribute it within the United States provided it meets all applicable FIFRA registration and labeling requirements.
Limited transfer, sale or distribution of an unregistered pesticide is possible under two scenarios: 1) if the transfer, sale, or distribution meets the applicable conditions set forth in 40 CFR 152.30 or 2) if the import of the unregistered pesticide is for the purpose of producing an unregistered pesticide intended solely for export and prepared or packed according to the specifications or directions of a foreign purchaser as explained in PR Notice 99-1.
What labeling is required on a pesticide being imported depends on whether the pesticide is registered or not. If registered, it must meet all labeling requirements of FIFRA and its implementing regulations. If not registered, the pesticide&#;s labeling must, based on the section 2(q) FIFRA definition of &#;misbranded,&#; include at least minimal directions for use, precautionary statements, an ingredient statement, the name and address of the producer, the name of the pesticide and net weight and if intended for export, a statement that the pesticide is not registered for use in the United States.
EPA's Office of Pesticide Programs has published a Web page that articulates and gives examples of some claims on cleaning products that require the products to be registered as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act. This Web page was prompted by several cases of non-compliance in the regulated community, especially among cleaners sold in Integrated Pest Management (IPM) product lines.
For more information, please see Determining If a Cleaning Product Is a Pesticide Under FIFRA.
Rodent glue board products are considered devices under FIFRA. In general, if an instrument or contrivance uses physical or mechanical means to trap, destroy, repel or mitigate any plant or animal life declared to be a pest (such as rodents), it is considered to be a device and is not subject to registration under the Federal Insecticide Fungicide and Rodenticide Act, Section 3 (FIFRA). While a Section 3 registration is not required for devices, they are subject to other requirements of FIFRA listed in 40 CFR Part 152 Subpart Z, including labeling regulations in 40 CFR Part 156. These requirements include but are not limited to: the device cannot bear false or misleading information, must bear the number of the registered EPA Establishment where the device was produced, and must bear adequate directions for use and warning or caution statements to prevent unreasonable adverse effects on the environment. Facilities that produce devices are also subject to the establishment registration and reporting requirements of FIFRA. These requirements are described in 40 CFR Parts 167 and 169. Devices produced by foreign manufacturers and imported in the United States must comply with all requirements applicable to domestic producers.
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:
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:
If a product makes a pesticidal claim and does not fit into one of the categories described above, then the product must be registered.
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.
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, , EPA issued a policy statement in the Federal Register (41 FR ) 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, 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 Notice as being subject to FIFRA's requirements for devices.
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.
&#;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.
PR Notice -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" o6+r "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.
No, the registrant cannot add an expiration date without EPA's approval. With the exemption of limited changes EPA has allowed changes to be made through notification or non-notification, all labeling changes must be approved by EPA. Supplemental labels are part of the labeling for a registered product and therefore must be reviewed and accepted by EPA before any amendments to that label are allowed (see 40 CFR 152.44(a) for more information). However, the Agency would like all supplemental labeling to have expiration dates and highly encourages registrant to add expiration dates using the amendment process.
The practice you describe is likely not acceptable for two reasons. First, relabeling a pesticide product, including causing new labeling to accompany it that was not included when the pesticide was released for shipment, is considered production under 40 CFR 167.3. The establishment where the relabeling takes place must be registered in accordance with 40 CFR 167.20. If the local distributors that were instructed to hand out the new label are not registered establishments, the production would be occurring unlawfully. This is true whether the local distributors are handing out a full section 3 label or whether they are handing out an approved supplemental label that would newly accompany the pesticide since its last production step. See also, LC07-.
Second, when a new section 3 label is distributed with a pesticide product that has the old section 3 label attached, it is possible that inconsistencies between the two labels will make the product misbranded. For example, if a change is made that does more than simply add to what was on the old label (e.g. adding a use or adding application equipment), the differences between the two labels could lead the labeling as a whole to be misleading and therefore misbranded under FIFRA 2(q)(1)(A). It is unlawful to sell or distribute a misbranded pesticide. FIFRA 12(a)(1)(E). Generally, when OPP staff review labels that add a new use, they evaluate and approve the label as a whole new label unless it specifies that part will be used as a supplemental label at which point it would be evaluated in conjunction with the old label. Because of this, OPP would not have determined that the new label as described in the question could be used in conjunction with the old label. Therefore OPP&#;s approval of the new label would not be an indication that use of both labels at the same time is acceptable.
If the drums are the package in which the pesticide is intended to be distributed or sold to the end-user, then adding a sticker of any kind would be altering the label, which without permission of the registrant is unlawful. See FIFRA 12(a)(2)(A). If done with the permission of the registrant, adding a sticker would be considered "production" under 40 CFR 167.3, which includes such actions as &#;&#;to package, repackage, label, relabel or otherwise change the container of any pesticide or device.&#; "Production" must occur in a registered establishment and must be reported in accordance with section 7 of FIFRA and its implementing regulations in 40 CFR Part 167. In addition to these requirements, if the dealer and registrant are not acting under a supplemental distributor agreement, the master label approved by EPA must include the information provided in the sticker. If the dealer is a supplemental distributor, 40 CFR 152.132(d)(2) allows the distributor product label to include the distributor name and address instead of that of the registrant. This replacement would not need to be included in the master label approved by EPA.
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 (-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.
LC07- deals with use of a supplemental label prior to that use being placed on a product label and put in distribution. Question LC08- discusses taking a use off of a label in production and placing it on a supplemental label. In question LC07- 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- 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-. Any supplemental labeling should be approved by the Agency. We will be revising the answer to LC07- to reflect and refer to LC08-.
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.
The supplemental labeling must be submitted and stamped &#;accepted&#; by the Agency. The Agency requires that these labels bear the following information:
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.
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:
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.
To answer how a supplemental label can be used in commerce, understand that EPA takes the position that any pesticide product that has already been released for shipment (as defined in 40 CFR 152.3) cannot be altered unless the change occurs in a registered establishment. Alterations such as affixing a supplemental label or otherwise making a supplemental label accompany a product are considered production and must be reported as such under FIFRA section 7. Such alterations may only be done at the direction of the registrant and in a registered pesticide producing establishment.
Attaching supplemental labeling inappropriately, either by downloading supplemental labeling from a website or handing out hard copy supplemental labeling at the point of sale, could be unlawful if it violates the production establishment registration and reporting provisions of FIFRA Section 7 (see FIFRA 12(a)(2)(L)). Further, sale and distribution of product that is inappropriately accompanied by supplemental labeling could constitute sale and distribution of a misbranded pesticide or a product with claims that substantially differ from what has been approved, which are an unlawful acts under FIFRA 12(a)(1)(E) and FIFRA 12(a)(1)(B).
Regarding the user of a product with supplemental labeling, EPA&#;s position is that the label on the container and the labeling that properly accompany the product are the labeling that must be followed. Failure to follow the labeling that was appropriately provided with the product could result in a use inconsistent with that labeling, which is a violation of FIFRA 12(a)(2)(G).
While it is not a violation for registrants to provide supplemental labeling on websites for informational purposes, EPA recommends marking such labeling in a way to notify users to follow the labeling associated with the product in hand.
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."
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 -5 concerning advisory versus mandatory language. 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).
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.
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.
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 . 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.
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.
40 CFR Part 152.25(b) exempts pheromones and pheromone traps that meet the conditions listed from all provisions of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). This would include the import and export requirements of FIFRA. Many pheromones are subject to the provisions of the Toxic Substances Control Act (TSCA). The checklist on page 19 of the following compliance guide Compliance Guide For the Chemical Import Requirements of the Toxic Substances Control Act explains how to comply with the TSCA import certification requirements. If the pheromone in question does not meet the conditions for exemption, it must be registered and would be subject to the export and import requirements of FIFRA.
Any pesticide imported into the United States must be accompanied by a Notice of Arrival that has been reviewed and signed by the appropriate EPA official and presented to U.S. Customs. In order for the Canadian company to move the product through the United States as an unregistered product (i.e., not bearing the U.S.-approved label) for the purpose of exporting it, they must comply with the Notice of Arrival requirement and export in accordance with FIFRA section 17(a) and the requirements of 40 CFR Part 168.65.
EPA has no requirement to list the country of origin on pesticide labeling, but if it is included it cannot be false or misleading. FIFRA 2(q)(1)(A) defines "misbranded" in part as "its labeling bears any statement... which is false or misleading in any particular." It is a violation of FIFRA to sell or distribute a misbranded pesticide. One way to express multiple counties of origin on the label would be to explain what parts of the production happened in which country. For example, for a product that was formulated in the United Kingdom but packaged and labeled in the United States, the label could state "Formulated in the UK and packaged and labeled in the USA." Note also that the label or immediate container must bear the establishment number of the establishment where the final production step occurred. 40 CFR 156.10(f). For the example above, that would be the establishment where the product was packaged and labeled.
The act of applying a label to a product, even a Canadian label, is considered &#;production&#; as per how the term "produce" is defined in 40 CFR § 167.3. Pursuant to 40 CFR § 167.20, any establishment where a pesticide is produced, including as well pesticide products for export, must be a registered establishment. The establishment must conform to all of the requirements of 40 CFR Part 167, including reporting the amount of product produced.
In the situation described above, it is also likely that the customer is creating an unregistered pesticide when it puts the Canadian label on the product. EPA has approved labeling, called "NAFTA labels," for a small number of products that meets both US and Canadian requirements and products bearing those labels would be considered registered. Information on NAFTA labels can be found at Implementing NAFTA Labels. Outside the use of NAFTA labels, unregistered pesticide products can be sold or distributed in the United States for export to Canada provided they meet the requirements of 40 CFR part 168 Subpart D, Export Policy and Procedures of Exporting Unregistered Pesticides.
No, the label of a pesticide manufactured only for export does not need to be approved by EPA. The label must, however, meet the requirements listed in 40 CFR 168.65. Some other FIFRA requirements also apply to pesticides manufactured for export; these are detailed in FIFRA section 17, 40 CFR 168.75 and 168.85.
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