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

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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On July 20, 2010, Representative Janice Schakowsky (D-IL) introduced the Safe Cosmetics Act of 2010 (H.R. 5786), which would amend the Federal Food, Drug, and Cosmetic Act (FFDCA) “to ensure the safe use of cosmetics.” Under the bill, the Secretary of the Food and Drug Administration (FDA) would:

1. Monitor developments in the scientific understanding of any adverse health effects related to the use of nanotechnology in the formulation of cosmetics; and
2. Consider scale-specific hazard properties of ingredients when conducting or reviewing safety substantiation of cosmetic ingredients.

Regarding cosmetic and ingredient statements, the bill would require manufacturers to submit electronically a statement containing certain information, including “the ingredient list as it appears on the cosmetic label or insert, including the particle size of any nanoscale cosmetic ingredients.” The bill would also allow the FDA Secretary to require that:

1. Minerals and other particulate ingredients be labeled as ‘nano-scale’ on a cosmetic ingredient label or list if not less than one dimension is 100 nanometers (nm) or smaller for not less than one percent of the ingredient particles in the cosmetic; and
2. Other ingredients in a cosmetic be designated with scale-specific information on a cosmetic ingredient label or list if such ingredients possess scale-specific hazard properties.

The bill was referred to the Committee on Energy and Commerce, as well as the Committee on Education and Labor.

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On July 12, 2010, the European Commission (EC) opened a public consultation on the pre-consultation opinion of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) entitled “Scientific Basis for the Definition of the Term ‘Nanomaterial.’” The EC states that its services need a working definition for the term “nanomaterial” to ensure the consistency of forthcoming regulatory developments, to guide the effective implementation of existing regulations, and to contribute to international work and dialogue on nanotechnology definitions. In its opinion, SCENIHR notes that the commonly used definition of the nanoscale is having a size between approximately 1 and 100 nanometers (nm). SCENIHR states, however, that there is no scientific evidence in favor of a single upper limit, and that there is no scientific evidence to qualify the appropriateness of the 100 nm value. According to SCENIHR, there is a need for a more elaborate description to identify unequivocally a nanomaterial or a product containing a nanomaterial for various European Union (EU) regulatory bodies. In its opinion, SCENIHR provides advice on the essential scientific elements of a working definition for the term “nanomaterial” for regulatory purposes, and discusses existing definitions formulated by various bodies. SCENIHR proposes to define an enforceable definition of “nanomaterial” for regulatory use by setting an upper limit for nanomaterial size, and adding to the proposed limit additional guidance (requirements) specific for the intended regulation. SCENIHR states:

Crucial in the guidance that needs to be provided is the extended description of the nanoscale. Merely defining single upper and lower cut-off limits is not sufficient in view of the size distributions occurring in manufactured nanomaterials. Although many nanomaterials are produced for specific properties at the nanoscale, at the moment it is not possible to identify a specific size or a specific generic property that is suddenly introduced or changed with size. Alternatively, a tiered approach may be required depending on the amount of information known for any specifically engineered nanomaterial and its proposed use.

Comments are due September 15, 2010.

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On July 7, 2010, the European Parliament (EP) voted that nanoscale ingredients should be banned from food in the European Union (EU) until the health and environmental risks they might pose are better understood, and that any nanoscale ingredients that are eventually authorized should be clearly labeled as such. The EP voted on several amendments to draft legislation concerning the authorization of novel foods, including a provision that would prohibit food from cloned animals or their offspring. The EP has been unable to reach agreement with the European Council on the legislation, largely because of the provision concerning cloned animals. The Council also disagrees that foods containing nanoscale ingredients should be systematically labeled, however. According to an EP spokesperson, the legislation likely will go to conciliation, during which the EP and European Council will attempt to negotiate a compromise after two readings have failed to produce an agreement. The legislation likely will be discussed again in the fall.

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On July 6, 2010, the White House Office of Science and Technology Policy (OSTP) published a Request for Information (RFI) on the National Nanotechnology Initiative (NNI). According to OSTP, the purpose of the RFI is to enhance the value of the NNI “by reaching out to the nanotechnology stakeholder community for specific input for the next NNI Strategic Plan to be published in December 2010.  The RFI refers to the NNI goals identified from the 2007 Strategic Plan as a starting point for questions covering themes such as research priorities, investment, coordination, partnerships, evaluation, and policy. OSTP states that it is interested in responses that address one or more of its questions, which are broadly categorized under goals and objectives; research priorities; investment; coordination and partnerships; evaluation; and policy, as related to the NNI.  Responses are due August 15, 2010.  OSTP states that submissions prior to the July 13-14, 2010, NNI Strategic Plan Stakeholder Workshop “may also inform dialogues” at the Workshop. OSTP intends to hold an “online public comment event” July 13-August 15, 2010, to solicit input on the NNI Strategic Plan.

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On July 1, 2010, the NanoBusiness Alliance issued a Position Statement on Nanomaterials Product Sustainability, which reflects its members’ “enduring commitment to managing effectively the environmental, health, and safety (EHS) implications of nanotechnology.” The NanoBusiness Alliance is committed to working with governments and nanomaterials stakeholders to manage the sustainable development and use of nanomaterials in a responsible way. The Position Statement states:

As an enabling technology applicable to diverse fields, including alternative energy, medicine, and electronics, among many others, nanotechnology offers tremendous value to society. As with any emerging technology, nanotechnology and nanoscale materials must be managed in a responsible way to identify and minimize any potential adverse effect on human health or the environment. The Alliance is committed to fostering the responsible and sustainable development of nanotechnology, to working with governmental and related nanotechnology stakeholders to develop appropriate scientific testing tools, methodologies, and data to characterize nanoscale materials, and to developing informed, science-based governance policies, laws, standards, practices, and regulations pertinent to nanoscale materials.

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On July 2, 2010, the European Commission’s (EC) Joint Research Centre (JRC) announced the availability of a reference report entitled Considerations on a Definition of Nanomaterial for Regulatory Purposes. JRC prepared the report in response to a request from the European Parliament (EP). JRC states that the aim of the report is to review and discuss issues and challenges related to a definition of “nanomaterial,” and to provide practical guidance for a definition for regulatory purposes. JRC suggests that a definition for regulatory purposes should:

• Only concern particulate nanomaterials;
• Be broadly applicable in European Union (EU) legislation, and in line with other approaches worldwide; and
• Use size as the only defining property.

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We are pleased to announce the release of the final white paper from the October 8-9, 2009, summit entitled “Environmentally Responsible Development of Nanotechnology,” which was held by The Research Triangle Environmental Health Collaborative. The charge for summit attendees was to explore issues regarding potential risk across nano-enabled product lifecycles, with the goal of generating a set of recommendations for North Carolina businesses regarding how to address such risks. The White Paper, to which Lynn L. Bergeson contributed, summarizes near-term recommendations resulting from the summit, as well as questions that should be considered in the interim to arrive at more solid long-term recommendations.

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On July 9, 2010, the American National Standards Institute (ANSI) will host a webinar to discuss draft international guidance on the labeling of manufactured nano-objects and products containing manufactured nano-objects. The European Committee for Standardization (CEN) Technical Committee (TC) 352 Nanotechnologies and the International Organization for Standardization (ISO) TC 229 Nanotechnologies are jointly developing a Technical Specification entitled “Guidance on the labeling of manufactured nano-objects and products containing manufactured nano-objects,” under the guidelines of the Vienna Agreement. CEN holds the leadership of this Technical Specification development activity. CEN and ISO/TC 229 were expected to distribute the draft Technical Specification June 18, 2010. Because ANSI expects the document to have broad implications for a number of U.S. industry sectors, including food safety/industry, cosmetics, and chemicals, the ANSI-Accredited U.S. Technical Advisory Group (TAG) to ISO TC 229 Nanotechnologies will host the webinar to review this document and solicit input from potentially affected U.S. stakeholders. The webinar will include an overview of the current draft of this proposed CEN/ISO Technical Specification (including background information to its development) and provide participants with the opportunity to ask questions and provide comments. These comments will be provided to the ANSI-Accredited U.S. TAG for consideration in connection with the development of the U.S. position and vote on this draft document. The webinar is free, but registration is required.

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