Regulatory Actions-United States-Federal

EPA | FDA | CPSC | OSHA | USDA

See also State and Municipal/Local.

June 2011:  In a joint memorandum, the White House's Emerging Technologies Interagency Policy Coordination Committee (ETIPC) set forth Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials.

Environmental Protection Agency (EPA)

Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)

Under FIFRA, EPA requires a manufacturer to register a product as a pesticide if that product incorporates a substance intended to destroy pests, including microbes. EPA has taken several actions on products containing silver that may or may not have been in nanoscale form.

September 2007: EPA issued a position on ion-generating devices, stating that the devices release substances intended to kill bacteria and must be registered as pesticides. Ion-generating devices include washing machines, dishwashers or other devices that electrolyze silver metal releasing silver ions into the water. EPA explicitly stated that it had "not yet received any information that suggests that this product uses nanotechnology," despite press accounts characterizing this action as a regulation of nanotechnology. At issue is whether the substances released from the ion-generating devices are nanosilver or simply silver ions (Ag⁺).

March 2008: EPA's Region IX office fined ATEN Technology, Inc. $208,000for failure of its subsidiary IOGEAR to register several antimicrobial computer mouse and mouse/keyboard combination products and for making unsubstantiated claims about their effectiveness.The computer equipment was coated with a thin film containing silver that was designed to kill bacteria on contact. The labels included the claim "Germ Free," though the products had not been registered with EPA.

September 2009: EPA filed suit against VF Corporation for the same infraction; that is, failure to register products that made unsubstantiated public health claims.  The products at issue here are 70 styles of footwear sold under the North Face brand that contain an AgION silver treated foot bed. The product labels declared that the products “inhibit the growth of disease-causing bacteria,” “prevent bacterial and fungal growth” and continuously release antimicrobial agents.

December 2010: EPA fined Monterey Park, California-based Kinetic Solutions, Inc. - doing business as Rabbit Air - $82,400 for allegedly selling unregistered and misbranded pesticides and making unproven claims about their effectiveness. EPA maintains that Kinetic Solutions Inc. made illegal public health claims for its air purifier branded "Nano Silver Pre Filter" and the filter's ability to control over 650 types of bacteria, a violation of the Federal Insecticide, Fungicide and Rodenticide Act.

June 2011: EPA Proposes Policy on Nanoscale Materials in Pesticide Products -  Pesticides; Policies Concerning Products Containing Nanoscale
Materials; Opportunity for Public Comment, 76 Fed. Reg. 35383 (June 17, 2011)
 

Toxic Substances Control Act (TSCA)

September 2008: EPA entered into a premanufacturing notice consent orderwith Thomas Swan & Co. Ltd. (Swan) regarding the manufacture of two of its nanotube products. In October 2008, EPA clarified its position on carbon nanotubes(CNT), stating that it considers CNTs new chemical substances and that if a CNT is not listed on the TSCA inventory, "anyone who intends to manufacture or import that CNT is required to submit a PMN (or applicable exemption) under TSCA section 5 at least 90 days before commencing manufacture." 

June 2009: EPA proposed a "significant new-use rule" (SNUR) that effectively extends the consent order entered into with Swan to all other manufacturers of similar CNT products. This order was withdrawnin August 2009 after EPA received notice that adverse comments were being prepared for submission. 

November 2009: EPA published Proposed Significant New Use Rules on Certain Chemical Substances that essentially classify all single walled and multiwalled carbon nanotubes to be hazards and requires protective measures to be taken when they are handled and notification of EPA at least 90 days before manufacture, import or processing occurs.

February-May 2010: EPA proposed a second SNUR for multi-walled carbon nanotubes described in premanufacture notice (PMN) P08-199. The SNUR specifies the use of gloves and protective clothing where there is potential for dermal exposure and a NIOSH-approved full-face respirator with an N100 cartridge where there is potential for inhalation exposure. In response to comments, EPA developed a "Summary of EPA's Current Assessments of Health and Environmental Effects of Carbon Nanotubes". 

Food and Drug Administration (FDA)

July 2007: FDA issued its Nanotechnology Task Force Report.

June 2011: FDA issued a draft guidance document Considering Whether an FDA-Regulated Product Involves the Application of anotechnology, Guidance for Industry

Federal Food, Drug and Cosmetic Act (FFDCA)

Consumer Product Safety Commission (CPSC)

October 2005: CPSC issued a "Nanomaterial Statement"

Consumer Product Safety Act (CPSA)

Federal Hazardous Substances Act (FHSA)

Poison Prevention Packaging Act (PPPA)

Occupational Safety and Health Administration (OSHA)

Occupational Safety and Health Act (OSH Act)

Relevant OSHA standards and other sources of information appear at OSHA's Nanotechnology Topic Page. OSHA otherwise has not developed nano-specific standard but the agency directs people to existing standards it believes might be applicable.  They include:

• 1910.132, Personal protective equipment, general requirements [Topic Page]
• 1910.133, Eye and face protection [Topic Page]
• 1910.134, Respiratory protection [Topic Page]
• 1910.138, Hand protection
• 1910.141, Sanitation
• 1910.1200, Hazard communication [Topic Page]
• 1910.1450, Occupational exposure to hazardous chemicals in laboratories [Topic Page]
• The substance-specific standards (e.g., 1910.1027, Cadmium) [Topic Page]

U.S. Department of Agriculture (USDA)

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