Nanotechnology Lawyer & Attorney : Bergeson & Campbell Law Firm : Nanotechnology Law Blog

On September 23, 2010, the Food and Drug Administration (FDA) will hold a public workshop entitled “Medical Devices & Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations.” According to FDA, the purpose of the workshop is to obtain information on manufacturing, characterization, and biocompatibility evaluation of medical devices containing or using nanomaterials and nanostructures, including diagnostics. FDA is seeking input on these topics and requests comments on a number of related questions. The workshop is open to the public, and the deadline for registration is September 15, 2010. Space availability permitting, on-site registration will be available on a first come first serve basis. Comments must be submitted by September 15, 2010, to be considered for the workshop discussion. All other comments are due October 22, 2010.

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According to the California Department of Toxic Substances Control's (CDTSC) website, it is drafting a memorandum of understanding (MOU) with the U.S. Environmental Protection Agency (EPA) to facilitate information exchange, collaboration, and outline a working partnership on emerging chemicals, green chemistry, and materials management. Under the new MOU, EPA and CDTSC will:

1.  Establish chemical specific teams for priority chemicals of mutual interest;

     a.  Teams will develop specific goals, points of coordination, and focus areas.

2.  Share information on analytical methods, fate and transport, bioconcentration, toxicity, exposure, risk assessment, and similar topics relative to emerging chemicals;

3.  Share literature reviews, databases;

4.  Collaborate on identifying and prioritizing information and data gaps;

5.  Keep each other informed on workshops, symposia, web events, etc.;

6.  Share value-chain information (to the extent allowed by law):

     a.  Producers, importers;

     b.  Production volumes; and

     c.  Applications/intermediates/products.

7.  Explore ways to exchange information while protecting CBI; and

8.  Collaborate on research needs and funding. 

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On August 13, 2010, the U.S. Environmental Protection Agency (EPA) announced that it is proposing to register conditionally a pesticide product containing nanosilver as a new active ingredient for a period of four years. According to EPA, the antimicrobial pesticide product, HeiQ AGS-20, is a silver-based product that is proposed for use as a preservative for textiles. As a condition of registration, EPA is proposing to require additional product chemistry, toxicology, exposure, and environmental data. EPA states that it will “evaluate these data as they are submitted during the period of the conditional registration to confirm the product will not cause unreasonable adverse effects to human health and the environment.” Under EPA’s new policy concerning public involvement in registration decisions, EPA is providing a 30-day opportunity for public comments on the proposed registration. Public comments will be accepted until September 11, 2010.

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On August 13, 2010, the U.S. Environmental Protection Agency (EPA) announced the availability of a draft document entitled Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray, which EPA intends to serve as part of a process to help identify and prioritize scientific and technical information that could be used in conducting comprehensive environmental assessments of selected nanomaterials. EPA states that the Case Study does not attempt to draw conclusions regarding potential environmental risks of nanoscale silver, but instead aims to identify what is known and unknown about nanoscale silver to support EPA’s future assessment efforts. EPA states that it is releasing the draft Case Study “solely for the purpose of pre-dissemination review under applicable information quality guidelines.” The draft Case Study “has not been formally disseminated by EPA,” and it “does not represent and should not be construed to represent any Agency policy or determination.” When preparing the final Case Study, EPA intends to consider any public comments received by September 27, 2010.

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Due to California’s budget issues and resulting furlough for civil service employees, the California Department of Toxic Substances Control (CDTSC) has postponed its August 13, 2010, workshop on state and federal nanomaterial activities. CDTSC, the U.S. Environmental Protection Agency (EPA), and the University of California, Los Angeles (UCLA) are cosponsoring the workshop to discuss the results of California’s carbon nanotube (CNT) information call-in, future data call-in requests for additional nanomaterials, and federal efforts related to CNTs for nanomaterials. CDTSC states that it will reschedule the workshop at a later date.

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The Massachusetts Office of Technical Assistance (MOTA) will post this week a Technology Guidance Document entitled “Nanotechnology -- Considerations for Safe Development,” which includes recommendations intended to enhance the safety of nanotechnology.  According to MOTA, it is providing the Guidance for “the express purpose of assisting in the development of this technology, as failure to prevent exposures or releases will not just risk harm to health or the environment -- it will also impede the common interest in realizing the benefits that nanotechnology can provide.”

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According to the Office of Management and Budget (OMB) website, on July 30, 2010, OMB received from the U.S. Environmental Protection Agency (EPA) a notice concerning “Pesticide Products Containing Nanoscale Materials.” No additional information regarding the notice is available on OMB’s website. During the April 29, 2010, meeting of EPA’s Pesticide Program Dialogue Committee (PPDC), William Jordan, Senior Policy Advisor, Office of Pesticide Programs (OPP), stated that EPA was in the process of preparing a Federal Register notice on nanomaterials and pesticide products. The notice will announce a new interpretation of Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(a)(2) regulations, that the presence of a nanoscale material is reportable under FIFRA Section 6(a)(2). This controversial interpretation would apply to already registered products, as well as products pending registration. In the same notice, EPA is expected also to memorialize OPP’s view that an active or inert ingredient would be considered “new” if it is a nanoscale material. The new policy would apply even when a non-nanoscale form of that same active or inert is already in a FIFRA-registered product. On June 25, 2010, the U.S. Government Accountability Office (GAO) issued a report entitled Nanotechnology: Nanomaterials Are Widely Used in Commerce, but EPA Faces Challenges in Regulating Risk, which recommends, among other actions, that EPA should complete its plan to clarify that nanoscale ingredients in already registered pesticides, as well as in those products for which registration is being sought, are to be reported to EPA and that EPA will consider nanoscale ingredients to be new. EPA responded that it agreed with GAO’s recommendation and is working on clarification of registrant’s responsibilities under FIFRA with respect to nanomaterials.

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The August 2010 issue of the National Institute of Environmental Health Sciences (NIEHS) Environmental Factor includes an article regarding the Intramural NanoHealth Signature Program, which is intended to investigate the health effects of engineered nanomaterials (ENM) in susceptible populations. According to the article, ENMs are increasingly found in medications, cosmetics, electronics, and other consumer products, creating environmental as well as occupational exposures. Over the next three years, researchers in the Clinical Research Unit (CRU) will engage in bidirectional collaborations with the National Toxicology Program (NTP), labs in the NIEHS intramural program, and the U.S. Environmental Protection Agency (EPA) as they explore the effects of exposure among healthy and susceptible populations to ENMs that are already present in the atmosphere.  The team will study the effects in cells tissue, animals, and human subjects. The research team will test the hypothesis that selected engineered nanomaterials induce pulmonary inflammation and that asthmatic individuals are particularly susceptible to ENM effects, in a translational exposure model with three aims:

• Exposing human bronchial epithelia and alveolar macrophages -- native lungs cells donated by healthy volunteers -- to ENMs ex vivo to evaluate inflammation and cell toxicity;
• Comparing the ex vivo response to ENMs of human bronchial epithelia and alveolar macrophages between healthy and asthmatic individuals to understand whether pre-existing disease alters the effect of ENMs on human cells; and
• Performing controlled chamber exposures of human volunteers to select ENMs of interest to assess the potential for effects on lung function and inflammation.

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On July 28, 2010, the U.S. Environmental Protection Agency (EPA) published a Federal Register notice announcing that it is reopening the comment period for its February 3, 2010, proposed significant new use rule (SNUR) for the chemical substance identified generically as multi-walled carbon nanotubes (P-08-199).  According to the July 28, 2010, notice, a commenter noted that neither the proposed rule nor the docket contained specific carbon nanotube data or data supporting the nature of the dermal concern for carbon nanotubes. The commenter stated it was not possible to assess EPA’s evaluation and determination based on the current record. Another commenter noted that EPA’s subsequent reviews and concerns for carbon nanotubes have expanded, and that the proposed SNUR should reflect those updated data. EPA states that it has added additional explanation and references of its health and environmental concerns for carbon nanotubes to the public docket for consideration, and is reopening the comment period for 30 days. Comments are due August 27, 2010.

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