Pesticide Labeling Questions & Answers - Multiple Products Packaged Together
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(Note: Contact your Pesticide Product Registration Ombudsman for specific label issues about a single product).
These answers are not intended to create significant new guidance or require any changes to previously accepted labeling. The Agency will contact registrants directly about how to correct problematic labels as appropriate. Changes to EPA accepted labeling will only be required in accordance with standard agency procedures. 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.
- Advertising Claims
- Antimicrobial Claims
- Contract Manufacture
- Use Sites
- Definitions of Terms
- Distributor Product Labeling
- Exception to Use in a Manner Not Permitted (FIFRA Sec 2ee)
- Existing Stocks
- General Labeling
- Labeling from Web Sites
- Multiple Products Packaged Together
- NAFTA Labeling
- Pesticide Exemption (FIFRA 25B)
- Pictures and Logos
- Repacked Products
- Service Containers
- Subject to FIFRA
- Superlative Terms
- Supplemental Labeling (NOT distributor products)
- Is it legal for a veterinary clinic to sell an individual dose of an EPA-regulated topical flea/tick product, i.e., break up a 3- or 6-pack and sell individual doses? If it is legal are there specific guidelines? LC11-0483; 12/19/11
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, 1979, 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 62940) (4 pp, 2 MB, About PDF). 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:
1) The pesticide to be repackaged is registered for a use consistent with the use for which it is prescribed and the use may not be a restricted use;
2) The veterinarian supplies the client with labeling for the pesticide that contains the common or trade name and percentage(s) of the active ingredient(s), the EPA product registration number, the use directions for the use prescribed, the name and address of the veterinarian, an antidote statement, directions for disposal of the pesticide and the package dispensed to the client, and human safety precautionary statements (including, but not limited to "for application to animals only," "keep out of reach of children," "in case of accident, contact local physician immediately");
3) The container is a child-resistant package; and
4) The pesticide is prescribed and dispensed to the client for the treatment of a specific pest problem, on a case-by-case basis, as part of the veterinarian's normal practice.
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.
A pesticide is sold as 10 1-fl-oz bottles in a box. A do-it-yourself pest store is selling the individual 1-oz bottles which do not have the full label. If they copy the full label and sell it with the bottle is this a violation? (LC09-0285; 7/21/09)
Unless the EPA registration allows and the registrant has authorized the do-it-yourself pest store to sell the bottles individually and to copy the label and provide it to the customer, the act of copying the label and providing it to the customer along with the individual bottle is considered production and sale of an unregistered pesticide. If the registrant authorizes the do-it-yourself pest store to open a box and sell individual bottles along with a copy of the full label and such sale is permitted under the registration, the do-it-yourself store would have to register as a producing establishment and file annual reports of their production. In addition, the individual bottles, if sold separately without the full labeling, are considered misbranded and it is a violation of section 12(a)(1)(F) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) to sell or distribute a misbranded pesticide.
“Kits” that contain multiple products. These kits often contain one or more FIFRA-regulated products, along with, in some cases, one or more non-FIFRA products. Each product in the kit is separately packaged and labeled – just as it would be if sold separately. The kit consists of an outer container, such as cardboard box, which houses the separately-packaged FIFRA and non-FIFRA products placed inside the outer container. (LC07-0106; 10/29/07)
Question 1. Does EPA want to review each kit label, even in cases where the label simply reprints the EPA-approved label language for each individual FIFRA product in the kit?
If the approved label(s) is visible through the outer packaging (e.g. visible through shrink-wrap), or if the outer packaging is an exact replica of the approved label(s), EPA does not need to review the kit label. If, however, the kit is sold under a separate name from its previously registered contents, the kit must be registered as a separate product and the kit label must be reviewed. 40 CFR 152.5 defines “pesticide product” as “a pesticide in the particular form (including composition, packaging, and labeling) in which the pesticide is, or is intended to be, distributed or sold.” 40 CFR 156.10(b)(2)(ii) requires pesticide products to have unique names. Therefore if the kit is considered anything more than the combination of separately named products (i.e., when the kit is marketed with its own distinct name), the kit must be registered.
Thus if the kit is being sold as a unique product requiring separate registration or the individual product labels are not visible from the outer container or the previously approved labels are not used on the outer container in their entirety without modification, EPA must review the labeling through the registration (in the case of a new product) or registration amendment process. The Agency may allow, if appropriate, a subset of the approved label to appear on the outer container. In all cases, the following items are required to be fully visible either through the outer packaging or on the outer container: 1. Product Name, 2. Registration Number, 3. Ingredient Statement, 4. Signal Word, 5. Keep out of reach of children statement, 6. Precautionary Statements, 7. The full directions for use or a referral statement to read the labels on the containers in the box for full directions for use, including mixing or sequential use of the products, 8. Name and address of producer or registrant, 9. Net weight, 10.If highly toxic, skull and crossbones, “poison,” and a statement of practical treatment in case of poisoning, 11. Use classification (e.g. Restricted use), 12.Establishment Registration
Question 2. If so, should the company submit the kit label to the team for each pesticide contained in the kit, so that the label can be included in the registration jacket for each pesticide in the kit?
If review is necessary and multiple pesticide products are contained within the kit, the outer container label must be reviewed by the particular team for each individual pesticide product contained inside. To help coordinate this review, it would be helpful to include a cover letter identifying the teams that will be reviewing the outer container label.>
Question 3. Please advise as to the appropriate method for submission. For example, should the submission be made by means of notification or registration amendment? Also, how should the submission be marked, so as to provide the reviewer a specific reference (e.g., regulation or PR Notice) for the submission.
If label review is necessary, the amended label must be submitted as a registration amendment. If no label review is necessary because approved labeling is visible either through the outer packaging or reprinted in total and the packaging changes meet the criteria found in PR 98-10 II.E., the change can be made through notification.
Question 4. As noted above, in some instances the kit will contain one or more FIFRA-products and one or more non-FIFRA products. Does EPA also want to review the label for such “mixed” product kits?
EPA has the responsibility to ensure that pesticide labeling – written, printed, or graphic matter accompanying the pesticide at any time – is not false or misleading before it is approved. See FIFRA §§ 3(c)(3)(5), 2(p)(2)(A). To that end, EPA will review labels for kits that contain both FIFRA and non-FIFRA products. Where non-FIFRA labeling is printed on the outer container, the labeling must be reviewed because the non-FIFRA labeling would not have been previously approved by EPA. EPA will review the pesticide portion of the label and relevant parts of the non-pesticide label (for instance, use of language that may interfere with the proper use of the pesticide). The non-pesticide component will not be stamped approved by EPA.