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EPA Unconditionally Registers New Nanosilver Product for Antimicrobial Use on Textiles

The U.S. Environmental Protection Agency (EPA) announced on July 2, 2020, that it has registered NSPW Nanosilver (a new nanosilver formulation) to suppress odor-causing bacteria and algae, fungus, mold, and mildew that can cause deterioration or staining in textiles.  Textiles that may be treated with NSPW Nanosilver include fabrics, sportswear, footwear, linens, and awnings.  NSPW Nanosilver is the active ingredient in the pesticide product POLYGUARD-NSPW MASTER BATCH (Polyguard).  The NSPW Nanosilver in Polyguard will be embedded within beads or pellets of a polymeric material in a “master batch,” and these beads of pellets will then be incorporated into treated textiles through a closed-loop manufacturing process.  EPA states that once the beads or pellets containing NSPW Nanosilver are introduced into this manufacturing process, no beads or pellets can escape into the environment.  EPA also states that the available data indicate that the leach rate of nanosilver from NSPW Nanosilver-treated textiles is below the limit of detection.

The same type of nanosilver was the active ingredient in another product that EPA previously conditionally registered under FIFRA Section 3(c)(7)(C) in 2015.  The U.S. Court of Appeals for the Ninth Circuit issued a decision vacating that conditional registration because the court concluded that the mandatory public interest finding by EPA was not adequately supported by the administrative record.  According to EPA, the new registration for NSPW Nanosilver involves a modified use pattern that will limit exposures compared to the product that received the previously vacated conditional registration.  Based on additional data that the applicant has submitted to support the use pattern as modified, EPA has prepared an updated risk assessment for NSPW Nanosilver and has determined based on that risk assessment that the product as modified meets the standard for an unconditional registration under FIFRA Section 3(c)(5).  Materials supporting this action will be posted in Docket ID EPA-HQ-OPP-2020-0043.

Commentary

Registering any new metallic silver product that satisfies the EPA criteria for classification as nanosilver for use as an antimicrobial pesticide presents special challenges, because EPA has adopted a policy that it will construe each new nanosilver product as a new pesticidal active ingredient.  The predecessor to NSPW Nanosilver (Nanosilva) was granted a conditional registration, a procedure that EPA uses when there are data gaps that must be filled before EPA is ready to make the determinations that would support issuance of an unconditional registration.  EPA may only issue a conditional registration for a product containing a new pesticidal active ingredient when EPA makes a determination that “use of the pesticide is in the public interest,” and the Ninth Circuit Court determined that EPA did not compile an administrative record adequate to support that finding.

Colloidal metallic silver products that meet the definition of nanosilver were first synthesized in the late 19th century.  Some industry stakeholders question whether the differences between different pesticide products that satisfy the EPA definition of nanosilver are sufficiently great to treat each new product as a new active ingredient, but it is also clear that the size and shape of the particles in these products do vary.  In this instance, EPA has determined that the supporting data for the application allow EPA to issue an unconditional registration.  Accordingly, the legal issue on which the Ninth Circuit based its prior decision to vacate the conditional registration for Nanosilva is not pertinent to the current registration decision.  Given the challenge to the prior registration decision, it will be important to monitor any opposition to the newly issued registration.

©2020 Bergeson & Campbell, P.C.National Law Review, Volume X, Number 189

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About this Author

Lisa Campbell, Bergeson PC, Federal Insecticide Fungicide Rodenticide Act attorney, TSCA lawyer, environmental statutes legal counsel, regulation compliance law
Partner

Lisa Campbell founded Bergeson & Campbell, P.C. (B&C®) with Lynn Bergeson. Today her practice focuses on many aspects of pesticide and chemical regulation. She counsels clients on a wide range of issues pertaining to exposure and risk assessment, risk communication, and related legal and regulatory aspects of pesticide programs under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). She also counsels B&C clients on various chemical-specific programs under the Toxic Substances Control Act (TSCA) as well as chemicals regulation and...

202-557-3802
Timothy Backstrom, Bergeson Campbell PC, Endangered Species Act attorney, EPA litigation, FIFRA lawyer, Clean Air regulation legal counsel, FOIA law
Of Counsel

Timothy Backstrom spent some 25 years in the U.S. Environmental Protection Agency’s (EPA) Office of General Counsel (OGC) working on pesticide, toxic substances, and air quality issues before coming to Bergeson & Campbell, P.C. (B&C®). He offers an extraordinary understanding of how EPA operates, as well as established relationships with many key players at EPA. He brings substantial litigation experience in both federal courts and administrative adjudications. He served for many years as the OGC’s designated administrative law expert and, among many accomplishments, he headed the trial team when EPA intervened in a hearing concerning a request for an exemption from the Endangered Species Act (ESA) for the northern spotted owl.

Besides insider knowledge of EPA, Mr. Backstrom delivers an unusual depth of expertise on pesticide registration issues and air toxics regulation, and a unique understanding of the EPA program requiring registration and testing of fuels and fuel additives. Having a technical background has allowed Mr. Backstrom to develop significant scientific expertise in toxicology and risk assessment. In the context of pesticide adjudications, he has presented and cross-examined numerous scientific witnesses. For many clients, he has identified additional options or theories that were not previously under consideration to resolve regulatory issues and to advance their business objectives.

202-557-3819
Carla Hutton, Bergeson Campbell PC, global regulatory attorney, public health activists lawyer, metals industry legal counsel, Toxic Substances Control Act law
Regulatory Analyst

Since 1996, Carla Hutton has monitored, researched, and written about regulatory and legislative issues that may potentially affect Bergeson & Campbell, P.C. (B&C®) clients. She is responsible for creating a number of monthly and quarterly regulatory updates for B&C's clients, as well as other documents, such as chemical-specific global assessments of regulatory developments and trends. She authors memoranda for B&C clients on regulatory and legislative developments, providing information that is focused, timely and applicable to client...

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