Pesticide Labeling Questions & Answers - Repacked Products
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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)
- A registrant company manufactures and packages a pesticide in one-time use containers with multiple containers within one box for sale. If the registrant company would supply a second company with materials to repackage the product to contain one individual use container, would the second company be considered a supplemental distributor? Also would the second company require any special licenses to perform this task? LC12-0577; 11/20/12
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.
- May a supplemental distributor take a product out of the original container and repackage it into smaller containers? (LC08-0214; 1.28.2009)
A supplemental distributor may take the product out of the original package and repackage it into smaller containers only if it is acting under the authority of the registrant to conduct such repackaging and only if the product as repackaged is consistent with the terms of the registration and EPA labeling regulations. Any repackaging must be completed in a registered establishment, as provided in 40 CFR part 167.
- I have a registered product with approved labels on the product bottle, and on the outside of the shipping container. If I take one bottle out of the case and ship it via a small package carrier, do I have to place the approved EPA label on the outside shipping carton? (LC08-0228; 1.28.09)
You are not required to place a product label on a shipping container unless the product is customarily sold at a retail establishment in the shipping container. See 40 CFR part 156.10(a)(4).
- I have a registered product that is a 100% repack of another registered pesticide product. Can I change the labeling of my product in accordance with PR Notice on notifications (PR Notice 98-10) even though the product label of the pesticide I am repackaging does not make this change? Can I drop uses from the label or make it more restrictive than the label of the pesticide I am repackaging? (LC08-0164; 5/15/08)
You may make certain changes to the 100% repack's label in accordance with PR Notice 98-10. While some changes to formulations are allowed through notification by PR Notice 98-10, you may not make any changes to your formulation for a 100% repack registration through notification. For example, any changes under PR Notice 98-10 Section III on Product Chemistry would be unacceptable (e.g. change in source of ingredient). In fact, if any change was made to the formulation, whether by notification or amendment, the registration would no longer be a 100% re-pack, which may affect use of the formulator's exemption found in 40 CFR 152.85. These changes would require citation or submission of data and may require EPA review of such data.
100% repack products may be registered for all or a subset of uses that the repackaged product is registered for. The proposed addition of uses not found on the source product label is generally not permitted.
Applicants may propose other changes in labeling but should be advised that label changes could give rise to a determination that the product is not eligible for the formulators exemption or "me-too" treatment under section 3(c)(7)(A) and 3(c)(3)(B) of FIFRA and that data must be submitted or cited to support such changes. As for dropping uses or adding restrictions to the label of a registered repack, 40 CFR 152.130(b) allows distribution or sale of a product with "labeling bearing any subset of approved uses provided that in limiting the uses listed on the label, no change would be necessary in precautionary statements, use classification, or packaging of the product." Therefore a 100% repack label could be marketed with all or some of the registered uses so long as limiting the use would not require a change in precautionary statements, use classification, or packaging of the product. However, if a registrant actually seeks to delete a use from the registration (rather than simply market a subset of approved uses), the product label must be amended through traditional label amendment procedures (except when uses are being deleted in response to a data call-in, See PR-N 98-10 II.F) and in all such cases the voluntary cancellation procedure found in FIFRA 6(f) must be used to delete the use from the registration. Adding restrictions to a label would necessitate changes in the directions for use on the label and such changes cannot be made through notification per PR Notice 98-10 but must be submitted as an amendment.