EPA agrees to regulate novel nanomaterials

nanoThe Environmental Protection Agency (EPA) has agreed to regulate nanomaterial pesticides as a result of a lawsuit filed by the Center for Food Safety. The complaint filed against the Environmental Protection Agency alleged failure to regulate over 400 nano silver products on the market. There are no labeling requirements for nano silver products, although it is considered a pesticide and active ingredient under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the primary federal law governing pesticide use in the United States.

Under FIFRA, any product containing an active ingredient that acts as a pesticide must be registered with EPA. For public health claims associated with pesticide use, EPA requires manufacturers to show that the product performs as intended and does not pose “unreasonable” adverse effects to the environment. “Unreasonable adverse effects on the environment,” is defined as one of two ways: (1) any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide, or (2) a human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with the Federal Food Drug and Cosmetic Act (FFDCA). The manufacturer must also submit a proposed label for the product that meets all of FIFRA’s labeling requirements.

The complaint accessible here: http://www.centerforfoodsafety.org/files/2014-12-16-dkt-1–pls–complaint_78869.pdf cites numerous environmental and public health concerns and requests injunctive relief.

The infinite small size of naomaterial provides extraordinary mobility for a manufactured material, as well as unique chemical and biological properties. Nanomaterials’ properties increase potential for biological interaction and increase potential for toxicity, which can result in DNA mutation, structural damage within the cell, and even cell death. Once in the blood stream, they can move freely through organs and tissues, including the brain, heart, liver, kidneys, spleen, bone marrow, and nervous system.

The petition was granted in part and denied in part. EPA agreed that nano-silver products intended to kill microorganisms qualify as pesticides, and that they are in fact a new type of novel pesticide, the safety of which cannot be assumed from data pertaining to the macro-counterpart of a nanomaterial. The agency also agreed that developers of such products must seek EPA review and approval before the products are allowed in the marketplace. EPA also agreed with the petitioners’ request that the agency require nano-specific data.

“We are gratified that EPA has now fundamentally acknowledged that, with regard to both the legal and scientific evidence, nano-silver antimicrobial products must be regulated as new pesticides,” said George Kimbrell, senior attorney at Center for Food Safety. “This is an important step in safeguarding the public.”

The EPA declined to undertake enforcement actions against all currently commercialized products that have not undergone the EPA registration process.

Center for Food Safety

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