Compounding World: July 2015
Manufacturers that want to use antimicrobials in medical applications must obtain the appropriate regulatory clearances. In the US, antimicrobials intended to control microorganisms on or in people or animals (e.g. on medical devices with this intent) fall under the jurisdiction of the Food and Drug Administration (FDA), while any other antimicrobial use falls under the Environmental Protection Agency (EPA's) Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Claims made for devices under FDA must be cleared by the 510(k) premarket notification process.
In Europe antimicrobial medical devices must be cleared by a Notified Body and frequently require a consultation with an EU Competent Authority says Moloney from Sciessent. In March 2015, Sciessent launched the Medical Device Market Acceleration Program (Med-MAP), which is designed to help manufactures efficiently move antimicrobial-treated products from concept and development to regulatory approval and commercialization in the US, Europe, Asia and Latin America. For example, Sciessent worked with a company to obtain Class 1 CE Mark Approval for an antimicrobial-treated, disposable, hygienic barrier that attaches to a blood-pressure cuff to prevent hospital-acquired infections. Sciessent recently put an Active Substance Master File on file with a Competent Authority in Europe as a resource for medical-device manufacturers looking for Class 111 CE Mark Approval.
RAS materials expects to receive EU approval for its nanosilver called Agpure. RAS says Safety studies were conducted by the Organisation for Economic Co-Operation and Developments (OECD's) Working Party on Manufactured Nanomaterials (WPMN), which uses Agpure as a reference material, notes Gregor Schneider from RAS. The company expects to receive EU approval under the Biocidal Products Regulation based on the OCED WPMN test results.
In the US, the same regulatory rules apply to nanosilver as any other biocide. "EPA's policy regarding nano-pesticides and inerts, albeit proposed, is clear: EPA applies an initial presumption that nanoscale versions of previously-registered active or inert ingredients in pesticide products are considered new ingredients subject to Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) registration," explains Lynn Bergeson, managing partner at Bergeson & Campbell, a Washington, DC law firm. "EPA also currently takes the position that each unregistered source of nanosilver is a new active ingredient and different than other currently registered sources of nanosilver. EPA has stated that, over time, it may develop the experience and establish a record that would allow EPA to conclude that different sources of nanosilver with the same particle size and charge are the same active ingredient".
EPA had previously issue one FIFRA registration for nanosilver to HeiQ for an antimicrobial fabric treatment, and this May issued a registration for an nanosilver - containing antimicrobial pesticide product named NSPW-L30SS to Nanosilva. According to an EPA announcement, "This silver–based product will be used as a non–food-contact preservative to protect plastics and textiles from odour and stain-causing bacteria, fungi, mould and mildew. Items to be treated include, for example, household items, electronics, sports gear, hospital equipment, bathroom fixtures and accessories."
After evaluating the available data, EPA said "these data show that plastic and textiles treated with NSPW-L30SS release exceedingly small amounts of silver. Based on this evaluation, the Agency determined that NSPW-L30SS will not cause unreasonable adverse effects on people or the environment than competing products and would be beneficial because it will introduce less silver than competing products. EPA is also requiring the Company to generate additional data to refine the Agency's exposure estimates."
In the US , Companies that wish to use or market nanosilver in plastics should seek advice from EPA's Office of Pesticide Programs (OPP) or seek legal counsel, advises Bergeson. "Marketers of such products are subject to intense scrutiny. Federal regulators are interested in compliance with FIFRA, state regulators are interested in compliance with state pesticide requirements, including state Attorneys General for compliance with state consumer protection laws, and citizen groups are interested in ensuring products marketed to consumers are legally compliant, registered as required, and safe when used as intended. Compliance with federal and state law is the best defence against potential tort actions that product manufacturers must also be careful to avoid."