40 CFR 165.67 - Registrants who distribute or sell pesticide products to refillers for repackaging.

§ 165.67 Registrants who distribute or sell pesticide products to refillers for repackaging.
(a) Must I comply with the standards in this section? You must comply with the standards in this section if you are a registrant who distributes or sells pesticide products to a refiller that is not part of your company for repackaging into refillable containers.
(b) Under what conditions can I allow a refiller to repackage my pesticide product into refillable containers? You may allow a refiller to repackage your pesticide product into refillable containers and to distribute or sell such repackaged product under your existing registration if all of the following conditions are satisfied:
(1) The repackaging results in no change to the pesticide formulation.
(2) One of the following conditions regarding a registered refilling establishment is satisfied:
(i) The pesticide product is repackaged at a refilling establishment registered with EPA as required by § 167.20 of this chapter.
(ii) The pesticide product is repackaged by a refilling establishment registered with EPA as required by § 167.20 of this chapter at the site of a user who intends to use or apply the product.
(3) You have entered into a written contract with the refiller to repackage the pesticide product and to use the label of your pesticide product.
(4) The pesticide product is repackaged only into refillable containers that meet the standards of subpart C of this part.
(5) The pesticide product is labeled with the product's label with no changes except the addition of an appropriate net contents statement and the refiller's EPA establishment number.
(c) What violations are applicable to illegal repackaging? Repackaging a pesticide product for distribution or sale without either obtaining a registration or meeting all of the conditions in paragraph (b) of this section is a violation of section 12 of the Act. Both you and the refiller that is repackaging your pesticide product under written contract with you may be liable for violations pertaining to the repackaged product.
(d) When must I provide the written contract to the refiller? If you allow a refiller to repackage your product as specified in paragraph (b) of this section you must provide the written contract referred to in paragraph (b)(3) of this section to the refiller before you distribute or sell the pesticide product to the refiller.
(e) Am I responsible for product integrity? Yes, for a product that you distribute or sell to a refiller that is not part of your company for repackaging into refillable containers, you are responsible for the pesticide product not being adulterated or different from the composition described in its confidential statement of formula that is required under FIFRA section 3.
(f) What information must I develop? For each pesticide product distributed or sold in refillable containers, you must develop both of the following documents in writing.
(1) You must develop a refilling residue removal procedure that describes how to remove pesticide residue from a refillable container (portable or stationary pesticide container) before it is refilled.
(i) The refilling residue removal procedure must be adequate to ensure that the composition of the pesticide product does not differ at the time of its distribution or sale from the composition described in its confidential statement of formula that is required under FIFRA section 3.
(ii) If the refilling residue removal procedure requires the use of a solvent other than the diluent used for applying the pesticide as specified on the labeling under “Directions for Use,” or if there is no diluent used for application, the refilling residue removal procedure must describe how to manage any rinsate resulting from the procedure in accordance with applicable Federal and State regulations.
(2) You must develop a description of acceptable refillable containers (portable or stationary pesticide containers) that can be used for distributing or selling that pesticide product.
(i) An acceptable container is one that you have determined meets the standards in subpart C of this part and is compatible with the pesticide formulation intended to be distributed and sold using the refillable container.
(ii) You must identify the containers by specifying the container materials of construction that are compatible with the pesticide formulation and specifying information necessary to confirm compliance with the refillable container requirements in subpart C of this part.
(g) When must I provide the information to the refiller? You must provide the refiller with all of the following information and documentation before or at the time of distribution or sale of your pesticide product to the refiller:
(1) Your written refilling residue removal procedure for the pesticide product.
(2) Your written description of acceptable containers for the pesticide product.
(3) The pesticide product's label and labeling.
(h) What recordkeeping must I do? You must maintain all of the records listed in this section for the current operating year and for 3 years after that. You must furnish these records for inspection and copying upon request by an employee of EPA or any entity designated by EPA, such as a State, another political subdivision or a Tribe:
(1) Each written contract entered into with a refiller for repackaging your pesticide product into refillable containers.
(2) Your written refilling residue removal procedure for the pesticide product.
(3) Your written description of acceptable containers for the pesticide product.
[71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64227, Oct. 29, 2008]

Title 40 published on 2014-07-01

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