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Home > Nanotechnology Columns > Bergeson & Campbell, P.C. Bergeson & Campbell, P.C.
 | | March 5th, 2013
EU-OSHA Posts Results of Project on Nano in Furniture
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. On March 4, 2013, the European Agency for Safety and Health at Work (EU-OSHA) announced the results of a joint project by the European Federation of Building and Woodworkers (EFBWW), the European Furniture Manufacturers Federation (UEA), and the European Furniture Industries Federation (EFIC) on the use of nanomaterials in the European furniture sector. Read the Whole Article |
 | | October 3rd, 2012
EC Adopts Communication on Second Regulatory Review on Nanomaterials
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. On October 3, 2012, the European Commission (EC) announced its adoption of a Communication on the Second Regulatory Review on Nanomaterials, which assesses the adequacy and implementation of European Union (EU) legislation for nanomaterials, indicates follow-up actions, and responds to issues raised by the European Parliament (EP), EU Council, and the European Economic and Social Committee. Read the Whole Article |
 | | September 13th, 2012
NNCO Will Hold Webinar on Nano.gov Website
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. In a September 13, 2012, Federal Register notice, the Office of Science and Technology Policy (OSTP) announced that the National Nanotechnology Coordination Office (NNCO) will hold a webinar on September 20, 2012, to provide an open forum to answer questions and hear suggestions related to the National Nanotechnology Initiative's (NNI) public website, which was redesigned in April 2011. Read the Whole Article |
 | | May 8th, 2012
CRS Publishes Nanotechnology Policy Primer
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. The Congressional Research Service (CRS) published an April 13, 2012, document entitled Nanotechnology: A Policy Primer that provides an overview of federal research and development (R&D) in nanotechnology, U.S. competitiveness, environmental, health, and safety (EHS) concerns, nanomanufacturing, and public understanding of and attitudes toward nanotechnology. Read the Whole Article |
 | | April 26th, 2012
FDA Issues Two New Draft Guidance Documents on Nanotechnology in Food Substances and Cosmetics
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. On April 25, 2012, the U.S. Food and Drug Administration (FDA) announced the issuance of two new draft guidance documents on the use of nanotechnology in food and cosmetic products -- "Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, including Food Ingredients that are Color Additives," and "Guidance for Industry: Safety of Nanomaterials in Cosmetic Products. Read the Whole Article |
 | | December 29th, 2011
EPA Publishes Proposed SNURs for CNTs and Fullerenes
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. The U.S. Environmental Protection Agency (EPA) published on December 28, 2011, proposed significant new use rules (SNUR) for 17 chemical substances that were the subject of premanufacture notices (PMN). 76 Fed. Reg. 81447. Of particular interest, seven of the PMN substances' reported chemical names include the term "carbon nanotube" (CNT) or "CNT" and seven of the PMN substances include the term "fullerene." Read the Whole Article |
 | | December 2nd, 2011
EPA Conditionally Registers Pesticide Product Containing Nanosilver as a New Active Ingredient
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. The U.S. Environmental Protection Agency (EPA) announced on December 1, 2011, that it is conditionally registering a pesticide product containing nanosilver as a new active ingredient. HeiQ AGS-20 is a silver-based antimicrobial pesticide product approved for use as a preservative for textiles. The final registration is not yet in the docket. The final registration is similar to the draft proposed registration issued last year, but additional data requirements have been imposed. As members of the nano community know well, that EPA has issued the registration in final is very good news and demonstrates that EPA is prepared to make regulatory decisions involving nanotechnology, even where, as here, they are likely to inspire controversy. Read the Whole Article |
 | | November 18th, 2011
EPA Posts Guidance to Facilitate Decisions for Sustainable Nanotechnology
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. The U.S. Environmental Protection Agency (EPA) posted a September 2011 guidance document entitled Guidance to Facilitate Decisions for Sustainable Nanotechnology, which was prepared by the National Risk Management Research Laboratory of the Office of Research and Development. EPA states that it developed the guidance to assist in assessing the sustainability of nanoproducts, and it is intended "to lay the groundwork for developing a decision-support framework through continual updates as research in this area progresses." The foundation of EPA's approach, according to the guidance, is to consider existing standards and methods for environmental, economic, and social assessments using a life cycle perspective and offer guidance by relaying first-hand knowledge of applying assessment tools to nanotechnologies, whenever possible. The guidance includes overviews of various assessment methodologies to help stakeholders make informed choices when selecting tools appropriate for their goals. Read the Whole Article |
 | | November 4th, 2011
ECHA Begins Consultation on Testing Proposal for Multi-Wall Carbon Nanotubes
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. On November 3, 2011, the European Chemicals Agency (ECHA) began a consultation on a testing proposal for multi-wall carbon nanotubes, synthetic graphite in tubular shape. Under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program, manufacturers and importers must obtain information on toxic effects of substances. REACH requires that new testing of a substance involving vertebrate animals be carried out only as a last resort, however. Read the Whole Article |
 | | October 11th, 2011
Nanotechnology Regulatory Science Act of 2011 Introduced in Senate
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. On October 6, 2011, Senator Mark L. Pryor (D-AR) introduced the Nanotechnology Regulatory Science Act of 2011 (S. 1662). The legislation is intended to address potential health and safety risks from products that contain nanotechnology materials. The bill would establish a program within the U.S. Food and Drug Administration (FDA) to assess the health and safety implications of using nanotechnology in everyday products and develop best practices for companies using nanotechnology. The legislation would authorize $48 million over three years, beginning in fiscal year 2013. Read the Whole Article |
 | | September 16th, 2011
A New Website for Nanotechnology Initiatives in California Is Available
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. B&C Consortia Management, L.L.C. (BCCM), an affiliate of Bergeson & Campbell, P.C., announced on September 15, 2011, the availability of a new website designed to be a platform for sharing information on nanotechnology policy, legislative, and regulatory initiatives in California. The website provides regular updates on areas and initiatives that could potentially impact the development or use of nanomaterials in California. It also includes information on broader nano-initiatives, recognizing that such initiatives can and will influence nanomaterials policy developments and decisions in California and elsewhere. Read the Whole Article |
 | | September 2nd, 2011
To Define or Not to Define: The War of Words
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. The August 25, 2011, issue of Nature includes a letter from Dr. Hermann Stamm, European Commission (EC) Joint Research Centre (JRC), Institute for Health and Consumer Protection (IHCP). In response to Dr. Andrew Maynard's article entitled "Don't define nanomaterials," in the July 7, 2011, issue of Nature, Stamm argues that a definition of engineered nanomaterials for regulatory purposes is "urgently needed." Read the Whole Article |
 | | August 25th, 2011
FDA Regulatory Science Plan Addresses Nanomaterials and Nanotechnology
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. The U.S. Food and Drug Administration (FDA) released on August 17, 2011, a document entitled Advancing Regulatory Science at FDA: A Strategic Plan. FDA states that its core responsibility is to protect consumers by applying the best possible science to its regulatory activities. FDA notes that rapid advances in innovative science have provided new technologies to discover, manufacture, and assess novel medical products, and to improve food safety and quality. FDA reportedly developed the Strategic Plan to keep pace with and use these new scientific advances. Read the Whole Article |
 | | August 19th, 2011
Presentations Available from US-EU Workshop: Bridging NanoEHS Research Efforts
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. The National Nanotechnology Initiative (NNI) posted recently the presentations from the March 10-11, 2011, workshop entitled "US-EU: Bridging NanoEHS Research Efforts." The workshop, which was convened in the Washington, D.C area, was intended to continue the robust dialogue between the U.S. and European Union (EU) on issues of shared concern pertinent to nanotechnology research initiatives. The workshop covered the following areas: significant discussion about environmental health and safety (EHS) questions for nanotechnology-enabled products; hands-on participation in joint programs of work that will better leverage resources; and development of communities of practice areas, including identification of key points of contact, interest groups, themes between key U.S. and EU researchers, and key U.S. and EU funding sources for near-term and future collaborations. Read the Whole Article |
 | | August 18th, 2011
NanoBusiness Commercialization Association to Meet in Boston
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. On September 25-27, 2011, the NanoBusiness Commercialization Association (NanoBCA) will commence its tenth annual conference at the Nanomanufacturing Summit in Boston, Massachusetts. The Summit will showcase emerging areas of nanomanufacturing and commercialization of nanotechnology-enabled products by leaders in the field of nanomanufacturing. This year's event is being co-organized by the National Nanomanufacturing Network (NNN) and NanoBCA (formerly the NanoBusiness Alliance), and provides an opportunity to network with the broader nanomanufacturing community to foster the critical collaboration and information exchange needed to realize both the societal and economic benefits offered by integrative nanomanufacturing techniques. Read the Whole Article |
 | | August 4th, 2011
IATP Report Critical of Development of Nanotechnology Products with Inadequate Regulatory Oversight
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. The Institute for Agriculture and Trade Policy (IATP) issued a June 29, 2011, report entitled Racing Ahead: U.S. Agri-Nanotechnology in the Absence of Regulation, which claims that at least 1,300 products with engineered nanotechnology materials (ENM) have been commercialized, "despite myriad uncertainties about the public health and environmental effects of ENMs." According to the report, several steps are needed for an operative and mandatory regulatory structure for nanotechnology products and processes, including an agreed legal definition of what constitutes an ENM and nanotech product data. The report describes the June 9, 2011, announcement by the U.S. Environmental Protection Agency (EPA) and Food and Drug Administration (FDA) of their intent to issue voluntary guidance to industry on nanotechnology products as "a small, but encouraging first step towards regulation." Read the Whole Article |
 | | July 30th, 2011
OEHHA Revises Proposed Regulation for Hazard Traits and Environmental and Toxicological Endpoints
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. The Office of Environmental Health Hazard Assessment (OEHHA) announced on July 29, 2011, that it revised its proposed regulation concerning the specification of hazard traits, environmental and toxicological endpoints, and other relevant data that are to be included in California's Green Chemistry Toxics Information Clearinghouse. The California Department of Toxic Substances Control (DTSC) will use information from the Clearinghouse to help identify chemicals of concern in consumer products as part of its Green Chemistry Program. Read the Whole Article |
 | | July 22nd, 2011
NNI Releases Reports from EHS Workshops
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. On July 19, 2011, the National Nanotechnology Initiative (NNI) announced the release of four reports from a series of workshops focusing on issues in the nanotechnology environmental, health, and safety (EHS) arena. The workshops were a part of an ongoing strategy to coordinate nanotechnology-related EHS research by convening experts from industry, academia, and the federal government to share the latest information and newest developments, to discuss the current state-of-the-science, and to identify research gaps in the nanotechnology-related EHS field. NNI states that "knowledge gleaned from the nanoEHS workshop series was critical to the development of the soon-to-be-released, updated NNI EHS Research Strategy." Read the Whole Article |
 | | July 20th, 2011
EPA Updates Information of Nano Regs
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. The U.S. Environmental Protection Agency's (EPA) July 7, 2011, Regulatory Agenda contains information of interest to nanotechnology stakeholders. The Regulatory Agenda is a summary of all rulemaking initiatives -- advanced, proposed, and near final -- that EPA has in the pipeline. The document is an excellent resource that lawyers and interested others routinely review to get a sense of what is coming down the pike. Read the Whole Article |
 | | July 13th, 2011
EPA Extends Comment Period on Nanoscale Materials in Pesticide Products
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on July 13, 2011, extending the comment period concerning possible approaches for obtaining information about what nanoscale materials are present in registered pesticide products until August 17, 2011. EPA received requests from CropLife America, the Biocides Panel of the American Chemistry Council, the Chemical Producers & Distributors Association, the International Center for Technology Assessment, and the NanoBusiness Commercialization Association (NanoBCA). Read the Whole Article |
 | | July 8th, 2011
Recast RoHS Directive: Nano Implications
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. The recast of the Directive on the Restrictions of Hazardous Substances (RoHS) was published in the July 1, 2011, Official Journal of the European Union. The notice calls for the restriction of other hazardous substances and their substitution by more "environmentally friendly alternatives." Importantly for nano stakeholders, the notice specifically states that these "other hazardous substances" include "any substances of very small size or with a very small internal or surface structure (nanomaterials) which may be hazardous due to properties relating to their size or structure." Read the Whole Article |
 | | June 30th, 2011
Netherlands Delegation Notes Risks Associated with Nanomaterials
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. The Netherlands delegation submitted a paper entitled "Risks associated with nanomaterials" for discussion during the June 21, 2011, meeting of the Environment Council of the European Union (EU). The paper states that under current EU legislation and the precautionary principle, "industry bears primary responsibility for the safety of its products for workers and consumers." The current legislation is intended, however, "to assess the hazards of chemical substances used in products, such as cosmetics, but is not geared to evaluating the specific hazards related to nanoengineered particles." According to the delegation, a key problem is the lack of a generally accepted definition of what constitutes a nanomaterial. Read the Whole Article |
 | | June 23rd, 2011
Senate Convenes Nano Caucus Briefing
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. On June 22, 2011, the Congressional Nanotechnology Caucus convened its first meeting in 2011 and hosted its inaugural Nanotechnology Caucus Lecture: Nanotechnology 101. The Nanotechnology Caucus is a bipartisan group of Members dedicated to promoting nanotechnology. Opening remarks were provided by Vincent Caprio, Executive Director, NanoBusiness Commercialization Association. Attendees were then treated to extensive remarks by Senator Ron Wyden (D-OR), a tireless champion of nanotechnology. Read the Whole Article |
 | | June 16th, 2011
FDA Issues Draft Guidance on Nanotechnology: Agency Will Accept Public Comment for 60 Days
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. On June 9, 2011, the Food and Drug Administration (FDA) posted on its home page a Draft Guidance on Considering Whether an FDA-Regulated Product Involves Application of Nanotechnology. FDA announced the availability of the Draft Guidance in the June 14, 2011, Federal Register. 76 Fed. Reg. 34715. FDA states that this document is the first step in providing regulatory clarity about the use of nanomaterials in FDA-regulated products and other more product-specific guidance documents are likely to follow. Specifically, the Draft Guidance is "intended to help industry and others identify when they should consider potential implications for regulatory status, safety, effectiveness, or public health impact that may arise with the application of nanotechnology in FDA-regulated products." Comments on the Draft Guidance are due August 15, 2011. Read the Whole Article |
 | | June 3rd, 2011
OECD Provides Snapshot on Current and Planned Activities on the Safety of Manufactured Nanomaterials
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. On May 26, 2011, the Organization for Economic Cooperation and Development (OECD) posted a useful document entitled "Current Developments/Activities on the Safety of Manufactured Nanomaterials." The document provides information on the outcomes and developments of the OECD Working Party on Manufactured Nanomaterials (WPMN) related to the safety of manufactured nanomaterials. OECD states that the document "provides a snapshot of information on current/planned activities related to the safety of manufactured nanomaterials in OECD member countries and other delegations that attended the 8th meeting of OECD's Working Party on Manufactured Nanomaterials (Paris France, 16-18 March 2011)." The document also includes written reports on current activities from other international organizations such as the International Organization for Standardization (ISO), Food and Agriculture Organization of the United Nations (FAO), and World Health Organization (WHO). Read the Whole Article |
 | | May 27th, 2011
Australia's NICNAS: New Chemicals Processes for Industrial Nanomaterials
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. Last October, the Australian Chemical Gazette announced that the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) was introducing new administrative processes for the notification and assessment of industrial nanomaterials that are considered to be "new" chemicals. The new administrative provisions were effective on January 1, 2011, and apply to any new chemical that falls under the working definition of "industrial nanomaterial." NICNAS also issued guidance on the notification program. Noted below is a brief background with the new notification program. Read the Whole Article |
 | | May 19th, 2011
ECHA Preparing Nano Inventory from REACH and CLP Submissions
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. The European Chemicals Agency (ECHA) is compiling an inventory of nanomaterials included in the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration dossiers and Classification, Labeling, and Packaging (CLP) notifications for the European Commission (EC), and intends to deliver the inventory by the end of June 2011. The EC requested the inventory in response to the 2009 European Parliament communication on nanomaterials. Read the Whole Article |
 | | May 11th, 2011
UCSF's Program on Reproductive Health and the Environment Publishes Recommendations for Addressing Health Risks from Nanomaterials in California
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. On May 5, 2011, the University of California, San Francisco's (UCSF) Program on Reproductive Health and the Environment announced the publication of its Recommendations for Addressing Potential Health Risks from Nanomaterials in California, which provides recommendations for addressing potential health risks from nanomaterials to the Office of Environmental Health Hazard Assessment (OEHHA) and to the State of California. OEHHA contracted with UCSF to prepare the report, which provides an overview of nanotechnology materials, potential exposures, and human-health risks, and recommendations for addressing potential health hazards and risks from nanotechnology. Recommendations include those that can be implemented under the existing regulatory structure of OEHHA, such as establishing a publicly accessible clearinghouse and inventory of nanomaterial sources and products. Read the Whole Article |
 | | May 6th, 2011
EPA Issues Final SNUR for Certain Multi-Walled Carbon Nanotubes
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. On May 6, 2011, the U.S. Environmental Protection Agency (EPA) promulgated a final significant new use rule (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the chemical substance identified generically as multi-walled carbon nanotubes (MWCNT), which was the subject of premanufacture notice (PMN) P-08-199. Under the final SNUR, persons intending to manufacture, import, or process MWCNT for a use that is designated as a significant new use by the final rule must notify EPA at least 90 days before commencing that activity. Read the Whole Article |
 | | April 29th, 2011
EPA Closing in On Nanopesticide Reporting Policy
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. About a year ago, the U.S. Environmental Protection Agency (EPA) announced its intent to adopt a policy presuming that an active or inert ingredient will be considered "new" under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) if the ingredient is or contains a "nanoscale material" and requiring any registrant of a pesticide product registered under FIFRA that is aware the product contains a nanoscale material to submit the information to EPA pursuant to FIFRA Section 6(a)(2). The "classification" policy came as no surprise and many believe it reflects a legally defensible interpretation of FIFRA. The "reporting" policy, however, was greeted with immediate and strong resistance. A logical inference of EPA's new reporting policy is that EPA must regard the mere presence of a nanoscale material to be "adverse" since EPA regulations generally limit the obligation of a registrant to report information pursuant to FIFRA Section 6(a)(2) to information that concerns "adverse effects." Read the Whole Article |
 | | April 16th, 2011
House Subcommittee Holds Hearing on NNI Oversight
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. On April 14, 2011, the House Science, Space, and Technology Subcommittee on Research and Science Education held a hearing entitled "Nanotechnology: Oversight of the National Nanotechnology Initiative and Priorities for the Future." According to the hearing charter, the purpose of the hearing was to examine the National Nanotechnology Initiative (NNI) and address the Nation's research and development priorities for the future. Read the Whole Article |
 | | April 15th, 2011
Industry Offers EPA First Nanomaterial Proposed Testing Agreement
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. On April 6, 2011, the NanoSafety Consortium submitted to the U.S. Environmental Protection Agency (EPA) a proposed testing agreement under Section 4 of the Toxic Substances Control Act (TSCA). The Consortium consists of a group of single-, double-, and multi-walled carbon nanotube manufacturers, including: Angstron Materials LLC, Applied Sciences, Inc., Cheap Tubes, Inc., Continental Carbon Nanotechnologies, Inc., Nano-C, Inc., NanoLab, Nanoshel, LLC, Pyrograf Products, SouthWest NanoTechnologies, Inc., and XG Sciences, Inc. Read the Whole Article |
 | | March 31st, 2011
Nanotech Items of Interest
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. 1) OECD Publishes Booklet On Nanosafety At The OECD 2) ASME Nanotechnology Institute Posts New Podcast In Nano Educational Series 3) NIOSH Requests Information To Update Its Nanotechnology Strategic Plan 4) PEN Reports Increase In Nano-Enabled Consumer Products Read the Whole Article |
 | | March 26th, 2011
What's New in the U.S. on Nano?
Lynn L. Bergeson Managing Director, Bergeson & Campbell, P.C. With GlobalChem 2011 concluding this week, it is timely to take stock in the status of nanotechnology governance activities underway at the federal level. Representatives from the U.S. Environmental Protection Agency (EPA) provided a brief update on regulatory initiatives in their remarks at the conference. Here is a quick summary of key initiatives. Read the Whole Article |
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