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Nanotech Regulatory Update: Will 2012 be the Year of Nano Regulations?

Posted in Nanotech Regulation

EPA and FDA both started 2012 by receiving criticism for their lack of management of nanomaterials in products the agencies regulate. EPA’s inspector general published a report released on December 29, 2011, entitled EPA Needs to Manage Nanomaterial Risks More Effectively in which the inspector general strongly criticizes the effectiveness of EPA’s management of nanomaterials. The report notes EPA’s failure to have in place a formal process to coordinate the distribution and use of information that companies are required to submit under existing regulations. One of the report conclusions is a recommendation that EPA should develop a way to gather and share nanomaterial information throughout the agency and with the public. A possible mechanism to achieve this would be to create a nanomaterials specific website. Although EPA’s response to the report lauded the “significant steps” the agency has taken to provide information regarding nanomaterials to the public, EPA has reportedly agreed to take additional steps to expand its existing procedures for sharing nanomaterial information between its various offices. 

FDA also started the year by getting dinged on its management of nanomaterials in consumer products. A coalition of nonprofits filed a law suit against the FDA seeking to have the agency respond to a 2006 petition to require labeling of nanotech ingredients in consumer products and extra health and environmental assessments. The FDA currently has no regulations for the use of nanomaterials in food. The coalition criticized FDA for repeatedly saying it has the ability and authority to regulate nanomaterials in consumer products, but for failing to do so. Although FDA issued a draft guidance on nanomaterials in food in June 2011, the coalition claims this is but an initial step toward providing regulatory clarity. In the void that exists regarding the use of nanomaterials in food, another nonprofit, As You Sow, recently published a Sourcing Framework for Food and Food Packaging Products Containing Nanomaterials. The framework is based on the precautionary principle, and was developed as a practical tool that urges companies to seek information from their suppliers about the safety of food products containing nanomaterials. 

Will this criticism result in increased regulation of nanomaterials by EPA and FDA in 2012? Only time will tell.