There have been three recent actions that could impact the regulatory landscape for treated articles and pesticide-impregnated materials. First, the Ninth Circuit issued a decision on May 30 vacating United States Environmental Protection Agency’s (EPA) conditional registration under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) of a liquid nanosilver product used as a material preservative, including in treated articles. Second, California issued a notice that each company with products treated with a pesticide product and sold under their own company name will now require registration in the state if the product includes pesticidal claims. Finally, the Center for Food Safety (CFS) and several other organizations have filed a petition requesting that EPA revise the treated article exemption at 40 CFR § 152.25(a) to exclude crop seeds coated with systemic insecticides.
Ninth Circuit Court Reverses USEPA Conditional Approval of Nanosilver Product
On May 30, the Ninth Circuit vacated the EPA’s conditional approval of Nanosilva LLC’s liquid nanosilver treatment, NSPW. NRDC v. EPA, No. 15-72308 (9th Cir. May 30, 2017). The NSPW product contains nanosilver as the active ingredient and is intended to be used as a materials preservative for plastic and textile products, including a wide range of household products. The Natural Resources Defense Council (NRDC) as well as the CFS and the International Center for Technology Assessment (ICTA) filed petitions in 2015 asking the court to set aside EPA’s conditional registration of NSPW.
The Ninth Circuit panel found that EPA made two assumptions when granting the conditional approval that were not supported by the evidence. First, the agency assumed that current users of conventional-silver pesticides would replace those products with Nanosilva’s new treatment. Second, EPA assumed the NSPW treatment would not be incorporated into new products in a way that would increase the amount of silver released into the environment.
The decision closely examines EPA’s statutory authority to issue conditional registration, finding that it involves a “more stringent test” than a standard registration:
[FIFRA] § 136a(c)(7)(C) does not presume, as the EPA argues, that the EPA may collect missing data related to its public-interest finding after granting a conditional registration. To the contrary, § 136a(c)(7)(C) only presumes the EPA needs more data to make a risk determination regarding use of the pesticide beyond the conditional-registration period. The statute instead requires the EPA to find, before granting conditional registration, “that use of the pesticide is in the public interest.” 7 U.S.C. § 136a(c)(7)(C) (emphasis added). In sum, the public-interest requirement of § 136a(c)(7)(C) is an additional, “more stringent test” that distinguishes conditional registration from unconditional registration.
Given this imposition of a “more stringent test” for conditional registrations of new active ingredients, the Ninth Circuit’s decision could impact EPA’s ability to issue such conditional registrations in the future.
Because the Ninth Circuit vacated the NSPW registration, this decision has immediate impact on products that contain NSPW and make antimicrobial claims. Under EPA’s treated article policy, treated article claims are only allowed for products treated with a registered antimicrobial. Thus, products treated with NSPW will not be able to make antimicrobial claims for their products based on NSPW unless and until the manufacturer is able to obtain a new registration.
California Requires the Registration of Distributor-Labelled Pesticide Impregnated Materials
On May 22, the California Department of Pesticide Regulation released California Notice 2017-08, Guidance on Registering Pesticide Impregnated Materials, which addresses the registration of pesticide impregnated materials bearing pesticide claims in California. Historically, these products were registered by either the manufacturer of the pesticide or by the company treating the bolts of fabric or clothing, but individual companies selling items made from pesticide impregnated textiles were not required to register the final textile products. Under this new policy, each retailer or brand partner with products made from pesticide impregnated material and sold under its own company name into or within California must also register their product(s).
The Notice specifies that each retailer/brand name partner will need to obtain at least one registration for each use category (apparel and/or non-apparel) of product sold under a unique company brand name. A registration in the “apparel” use category would include all the company’s wearable items under the same brand name (e.g., shirts, pants, shorts, socks, hats, and jackets for humans and animals). One registration in the “non-apparel” use category would include all of company’s non-wearable items under the same brand name (e.g., bedding, horse blankets, tents, seat covers, chopping blocks, shower curtains, and mouse pads).
The policy change will become effective July 1, 2017.
While this final Notice has been long in the works, it represents a significant change that will impose registration requirements on many companies that are not in the “pesticide business” and may be less familiar with pesticide regulatory requirements. For example, some retailers sell pesticide-impregnated clothing under their own “store label”. Such companies will now face a range of new regulatory requirements beyond just the initial registration requirement, including the California Mill Tax.
It is important to note that this Notice does not change the state’s policy regarding treated articles. Treated articles that meet the definition set forth in 40 CFR §152.25(a), including that any pesticidal claims are limited to protection of the article, are exempt from registration under federal and California law.
EPA Petitioned to Eliminate the Treated Article Exemption’s Application to Treated Crop Seeds
Several petitioners, including the Pesticide Action Network of North America, American Beekeeping Federation, American Honey Producers Association, Pollinator Stewardship Council, American Bird Conservancy, and the CFS have filed a petition with EPA arguing that crop seeds coated with systemic insecticides are improperly relying on the treated article exemption and thus, are avoiding FIFRA’s registration and labeling requirements. Dated April 27, 2017, the petition requests that EPA either amend or formally reinterpret the Treated Article Exemption “to clearly communicate to the regulated community that systemic pesticidal seeds intended to kill pests of the plants are not included under the Treated Article Exemption and are therefore subject to FIFRA’s requirements for registration and labeling.” The petition also requests that EPA “aggressively enforce FIFRA’s registration and labeling requirements for each separate seed product coated in systemic insecticides, in order to properly discharge its duty to protect the public and environment.”
EPA is not legally required to act on such a petition within any particular timeframe, so it is possible the petition will simply languish at EPA. While it remains to be seen whether the petition will receive any attention at EPA, any proposed changes or re-interpretation of the treated article exemption deserve monitoring.
We will continue to monitor these actions and will provide updates as they arise.