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Author Archive: Bernard Freedman

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02/01/2013

Nanotechnology: Who does the EPA Serve?

 

The 9th Circuit Court of Appeals recently heard oral argument in the case of NATURAL RESOURCES DEFENSE COUNCIL,( NRDC), vs. ENVIRONMENTAL PROTECTION AGENCY, Case# 12-70268, regarding the EPA’s conditional approval of a nano-silver product made by a Swiss company HeiQ Materials. The Amicus briefs describe it as: 

the EPA’s unprecedented decision to conditionally register the nano-silver pesticide products HeiQ AGS-20 …as unsupported by substantial evidence. EPA has failed to show that the conditional registration will not cause any unreasonable adverse effect” on human health and the environment. The limited studies to this point have raised significant red flags about nano-silver.”

The Product is HeiQ AGS-20, as described by its manufacturer, provides antimicrobial protection for textiles (e.g. blankets) and medical products … (wound dressings, implants) with unique durability and effectiveness… contribute to healing, increased safety and faster recovery. 

The issue in this case is the legality of the EPA’s interpretation that the interest of the public and of business trumps the EPA’s administrative mandate to first determine the safety of pesticides and to affirmatively determine that a product does not have  “unreasonable adverse effects.” In this case infants and children under 2 have not been studied regarding fabrics containing nano-silver if chewed  by infants or children 1 or 2 years of age. The fear is an increased risk of injury or death.   Although the EPA is required to evaluate risk, they did not do so in the group most likely to ingest nano-silver – infants and children 1 to 2 years old who chew on materials available to them.

During oral argument in the Court of Appeal, one Justice questioned counsel for the NRDC as to whether we should do away with stairs because babies fall down the stairs all the time – isn’t there a risk in everything that we do?

This joking cynicism fails to appreciate the unknown risks of nanotechnology and perhaps parallels the ignorance of the majority of the public as to dangers of working with substances of unknown nature. According to an amicus brief filed on behalf of various organizations, both private industry and governments are spending billions of dollars on research and development of nano technology. Nano-silver is the largest area with the greatest amount of new products at the present time. To date, however, no labeling with respect to unknown risks is required.

The EPA regulates nano-silver products, as pesticides because the intended purpose is antibacterial and antimicrobial. The risks involve potential toxicity from individual one time exposure to dose related effects from the aggregate expose to numerous products such as, sunscreens, food packaging, children’s toys and pacifiers, laundry detergent, personal hygiene products, jeweler, bedding and furniture, underwear, hair brushes, creams, lotions, pillows, and toothbrushes.

Nano materials can be absorbed into the brain (able to get across the blood brain barrier), liver, heart, kidney, spleen, bone marrow as well as the nervous system.

It is the EPA’s job, its burden of proof, to determine before registering a pesticide, that it will not cause any “unreasonable adverse effects” on human health and the environment. That is the EPA’s affirmative duty and thus cannot be delegated to the manufacturer or anyone else. The EPA has in this instance chosen to give a conditional approval permitting the manufacturer to market it for 4 years – and then see what happens.

The justification for giving HeiQ conditional approval, as stated by the EPA: “the Agency has considered the nature and its pattern of use, application methods and rates, and level and extent of potential exposure. Based on these reviews, the Agency was able to make basic health and safety determinations which show that use of HeiQ AGS-20 during the period of conditional registration will not cause any unreasonable adverse effect on the environment, and that use of the pesticide is, in the public interest. “     

Whether this is a sufficient predicate to conditionally approve the product, or whether the EPA is shirking its duty under its administrative mandate, should be at the core of the Court of Appeals’ decision. The statute requires that “ The Agency will approve an application only if:… The Agency has determined that the product will perform its intended function without unreasonable adverse effects …”

                                                                                                                    

 

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