Nano and Other Emerging Chemical Technologies Law Blog: Lawyer & Attorney : Bergeson & Campbell Law Firm : Nanotech and Chemical Legal Developments

Last week, the U.S. Environmental Protection Agency posted a submission made by BASF Chemical Company under Section 8(e) of the Toxic Substances Control Act (TSCA), which requires U.S. chemical manufacturers, importers, processors and distributors to notify EPA within 30 calendar days of new, unpublished information on their chemicals that may lead to a conclusion of substantial risk to human health or to the environment. In its July 8, 2008, submission, BASF submitted the results of a subchronic inhalation study in rats, reporting that the no observed effect concentration is below 0.1 mg/m³. In a September 9, 2008, letter, EPA’s Office of Pollution Prevention and Toxics (OPPT) states that it conducts preliminary screens of all Section 8(e) submissions and routinely requests additional information from submitters to complete these preliminary screens or to evaluate submissions further. OPPT requested the complete report from BASF.

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According to the Office of the Federal Register, tomorrow the U.S. Environmental Protection Agency (EPA) will publish a notice regarding the Toxic Substances Control Act (TSCA) requirements potentially applicable to carbon nanotubes (CNT). EPA states that it “generally considers CNTs to be chemical substances distinct from graphite or other allotropes of carbon listed on the TSCA Inventory.” As a result, many CNTs may therefore be new chemicals under TSCA Section 5. Manufacturers or importers of CNTs not on the TSCA Inventory must submit a premanufacture notice (PMN) (or applicable exemption) under TSCA Section 5 where required under 40 C.F.R. Part 720 or Part 723. To determine the TSCA Inventory status of a CNT, a manufacturer may submit to EPA a bona fide intent to manufacture or import under 40 C.F.R. Section 720.25.  According to the notice, some time after March 1, 2009, EPA anticipates focusing its compliance monitoring efforts to determine if companies are complying with TSCA Section 5 requirements for CNTs.

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On October 8, 2008, the European Commission (EC) published a regulation amending the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) Annex IV to remove carbon and graphite. Although the substances were originally listed in Annex IV, meaning they were exempt from REACH requirements because they were considered to be of minimum risk because of their intrinsic properties, a European Union (EU) expert committee delisted the substances in June 2008. According to the regulation, there is insufficient information for carbon and graphite to be listed in Annex IV, “in particular due to the fact that the concerned EINECS and/or CAS numbers are used to identify forms of carbon or graphite at the nano-scale, which do not meet the criteria for inclusion in this Annex.”

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The Environmental Defense Fund (EDF) recently posted two blog items regarding a consent order negotiated by the U.S. Environmental Protection Agency (EPA). The October 9, 2008, item states that EPA intends to issue a sanitized version of a consent order negotiated with a producer of multiwalled carbon nanotubes (MWCNT). According to EDF, the order was prompted by EPA’s review of a premanufacturing notification (PMN).

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In an October 2, 2008, Update entitled “NIOSH Nanotechnology Research News Notes:  New Papers on PPE, Toxicity; New Partnerships, Award,” the National Institute for Occupational Safety and Health (NIOSH) describes two new peer-reviewed papers, two new international partnerships, and a professional award.

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On September 30, 2008, the Project on Emerging Nanotechnologies (PEN) released the results of a poll regarding nanotechnology and synthetic biology. According to PEN, almost half of U.S. adults have heard nothing about nanotechnology, and nearly nine in 10 Americans say they have heard only a little or nothing at all about synthetic biology. PEN states that, based on the poll results, “the level of U.S. public awareness about nanotechnology has not changed measurably since 2004,” when PEN sponsored the first poll on the topic. In synthetic biology, advanced science and engineering are used to construct or re-design living organisms so that they can carry out specific functions. PEN predicts that this emerging technology will likely develop rapidly in the coming years. According to PEN, the first synthetic biology “blockbuster” drug is anticipated to hit the market in the near future -- an affordable treatment for the 500 million people in the world suffering from malaria.

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Beginning November 15, 2008, the Continental Western Insurance Group will no longer cover bodily injury, property damage, or personal and advertising injury from “nanotubes or nanotechnology in any form.” The company said its intent was to “remove coverage for the, as of yet, unknown and unknowable risks created by the products and processes that involve nanotubes.” According to the company, “reports have raised concerns regarding health risks from workers that may be inhaling carbon nanotubes during the manufacture of certain products. The carbon nanotubes resemble asbestos fibers in appearance, raising the concern that they may cause illness similar to that linked to asbestos.” The company concluded that it would not be prudent “to knowingly provide coverage for risks that are, as of yet, unknown and unquantifiable. We are all too aware of what happened to companies involved in asbestos-related exposures in the past, and see this as a very similar issue. By excluding coverage for bodily injury and property damage specifically caused by nanotubes and nanotechnology, we can continue to provide coverage for other exposures in the multitude of companies and products using nanotechnology now and in the future.” According to the notice to policyholders, the exclusion would apply to situations including “the use of, consumption of, ingestion of, inhalation of, absorption of, contact with, existence of, presence of, proliferation of, discharge of, dispersal of, seepage of, migration of, release of, escape of, or exposure to nanotubes or nanotechnology.”

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