EPA knöpft sich "antimikrobielle Produkte" unter FIFRA vor
Der Outdoorbekleidungsfirma The North Face droht laut einer Pressemitteilung der US Umweltbehörde EPA eine Busse von bis zu $1,000,000, weil sie angeblich unbegründete Produkteigenschaften durch den Einsatz der Agion Silberionen-Technologie ausgelobt hatte. Zudem kündigt die EPA im Bundesregister an, dass sich die wissenschaftliche Begleitgruppe zum Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) am 3. bis 6. November 2009 treffen wird, um eine Reihe an wissenschaftlichen Standpunkten in Bezug auf die Bewertung der Gefahren und Exposition im Zusammenhang mit Nanosilber und anderen Nanometall-Pestiziden zu diskutieren.
The EPA maintains that The North Face made unsubstantiated public health claims regarding unregistered products, and their ability to control germs and pathogens - a violation of the Federal Insecticide, Fungicide, and Rodenticide Act.
At issue were more than 70 styles of footwear that incorporated an AgION silver treated footbed. The company sold the products making unsubstantiated claims that the footwear would prevent disease-causing bacteria. Specifically, The North Face made the following public health claims about the footwear on-line and on product packaging:
- ‘AgION antimicrobial silver agent inhibits the growth of disease-causing bacteria’
- ‘Prevents bacterial and fungal growth’
- Continuous release of antimicrobial agents”
Products that kill or repel bacteria or germs are considered pesticides, and must be registered with the EPA prior to distribution or sale. The Agency will not register a pesticide until it has been tested to show that it will not pose an unreasonable risk when used according to the directions.
The U.S. Environmental Protection Agency (EPA) also announced in a September 16, 2009, Federal Register notice that the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) will meet November 3-6, 2009, “to consider and review a set of scientific issues related to the assessment of hazard and exposure associated with nanosilver and other nanometal pesticide products.”
FIFRA SAP serves as the primary scientific peer review mechanism of EPA's Office of Prevention, Pesticides and Toxic Substances (OPPTS) and is structured to provide scientific advice, information and recommendations to the EPA Administrator on pesticides and pesticide-related issues as to the impact of regulatory actions on health and the environment.
Companies with an interest in marketing products that contain nanosilver and/or other nanometals or nanometal oxides as pesticides regulated under FIFRA have approached the Office of Pesticide Programs (OPP) seeking product registration. Based on OPP's understanding of the scientific literature, it appears that there may be potential for pesticides containing nanoscale materials to pose different risks to humans and the environment than those of pesticides that do not contain nanomaterials.
The Agency will hold a consultation meeting with the FIFRA Scientific Advisory Panel (SAP) to obtain advice and recommendations on the following issues that are associated with the
identification and assessment of these potential risks:
- Scientific evidence that nanosilver and other nanometals/nanometal oxides with dimensions in the range of 1 - ~100 nm have unique behavior under conditions relevant to human and environmental risk assessment and other properties (in addition to size) that may influence this behavior.
- Recommendations regarding the types of data that OPP should require to evaluate the risks to humans and the environment for products containing free nanosilver and/or nanometals or nanometal oxides and products with incorporated nanosilver and/or nanometals or nanometal oxides with variable potential to leach and the relative priorities for obtaining recommended types of data.
- Recommendations regarding how OPP should conduct risk assessments of pesticide products containing nanosilver and/or nanometals or nanometal oxides.