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Download transcript. This week I discuss with my colleague, Mark Washko, Senior Government Affairs Advisor for B&C and The Acta Group, our consulting affiliate, the new 119th Congress and what might be key legislative actions our listeners should look for. The new Congress reflects many new members, new staffs, and a new Republican majority in both chambers. What can we expect? Will Congressional Review Act measures un-do key Biden initiatives? What might we expect in terms...

According to the Toxics Use Reduction Institute’s (TURI) website, the Toxics Use Reduction Act (TURA) Program in Massachusetts has received a petition to list carbon nanotubes (both single-walled and multi-walled) and carbon nanofibers.  The TURA Science Advisory Board (SAB) is beginning the process of reviewing these substances and seeks additional information from stakeholders.  SAB’s primary role is to consider petitions to add or delete chemicals from the TURA list and...

The U.S. Environmental Protection Agency (EPA) posted on September 30, 2013, a final report entitled Comprehensive Environmental Assessment Applied to Multiwalled Carbon Nanotube Flame-Retardant Coatings in Upholstery Textiles: A Case Study Presenting Priority Research Gaps for Future Risk Assessments. The final report presents a case study of multiwalled carbon nanotubes (MWCNT) used in flame-retardant coatings applied to upholstery textiles. EPA states that the case study is organized...

The U.S. Environmental Protection Agency’s (EPA) Toxic Substances Control Act (TSCA) Section 8(a) proposed rule concerning reporting and recordkeeping requirements for certain chemical substances when manufactured or processed at the nanoscale was published in the April 6, 2015, Federal Register.  EPA proposes to require persons that manufacture or process these chemical substances to report electronically to EPA certain information, including the specific chemical identity, production...

The U.S. Department of Agriculture (USDA) National Organic Program (NOP) issued on March 24, 2015, a policy memorandum clarifying the status of nanotechnology in organic production and handling under the USDA organic regulations.  The memorandum states that NOP has received questions about the use of nanotechnology.  The memorandum uses the term “engineered nanomaterials” to refer to substances specifically designed and manufactured to have unique properties or behavior attributable to...

Almost seven years ago, the International Center for Technology Assessment (ICTA) filed a petition for rulemaking requesting that the U.S. Environmental Protection Agency (EPA) regulate products containing nanosilver as pesticides and for related other forms of relief.  On March 19, 2015, EPA responded to the petition.  In general, the response does not alter EPA’s legal position with regard to nanosilver and its regulation under the Federal Insecticide, Fungicide, and...

On March 25, 2015, the U.S. Environmental Protection Agency (EPA) issued a prepublication version of a Toxic Substances Control Act (TSCA) Section 8(a) proposed rule concerning reporting and recordkeeping requirements for certain chemical substances when manufactured (including imported) or processed at the nanoscale. EPA proposes to require persons that manufacture or process these chemical substances to report electronically to EPA certain information, including the specific chemical...

The National Nanotechnology Initiative (NNI) published on March 11, 2015, its supplement to the President’s 2016 budget submitted to Congress.  NNI states that the supplement serves as the NNI annual report.  According to the annual report, in 2014, federal agencies invested $1.57 billion in nanotechnology-related activities.  The President’s 2016 request calls for an investment of $1.50 billion, which the report states “affirm[s] the Administration’s continuing...

The National Nanotechnology Initiative (NNI) published on March 12, 2015, the proceedings of a September 15, 2014, meeting on “Realizing the Promise of Carbon Nanotubes: Challenges, Opportunities, and the Pathway to Commercialization,” held at the National Aeronautics and Space Administration (NASA) Headquarters.  According to NNI, a number of common themes and potential future research and development priorities emerged: NNI states that the outcomes of the meeting will help...

On January 30, 2015, the American Conference of Governmental Industrial Hygienists (ACGIH®) announced the under study list for its Threshold Limit Values for Chemical Substances (TLV®-CS) Committee.  The under study list includes, under other issues under study, “nanoscale primary particle notation.”  According to ACGIH®, the under study list serves as “notification and invitation to interested parties to submit substantive data and comments to assist the...

The Consumer Product Safety Commission’s (CPSC) fiscal year (FY) 2016 budget request includes funding to establish a Center for Consumer Product Applications and Safety Implications of Nanotechnology (CPASION), which is intended “to develop robust methods in identifying and characterizing nanomaterials in consumer products; to understand their effects on human exposure; and to develop scientists to advance nanomaterials in consumer product safety research.”  CPSC recommends a $5 million...

On February 2, 2015, the U.S. Environmental Protection Agency (EPA) promulgated through a direct final rule significant new use rules (SNURs) for 27 chemical substances that were the subject of premanufacture notices (PMNs).  The substances include polymer of terephthalic acid and ethyl benzene with multi-walled carbon nanotube (generic) (PMN Number P-13-573), which is subject to a Toxic Substances Control Act (TSCA) Section 5(e) consent order.  The consent order requires the following...

The National Nanotechnology Coordination Office (NNCO), on behalf of the Nanoscale Science, Engineering, and Technology Subcommittee of the Committee on Technology, National Science, and Technology Council, will hold a series of webinars in 2015 focusing on the experiences, successes, and challenges for small- and medium-sized enterprises (SME) working in nanotechnology and on issues of interest to the business community. The first webinar, which will address “What are the biggest issues...

According to a Federal Register notice scheduled for publication on December 23, 2014, the U.S. Environmental Protection Agency (EPA) is withdrawing several direct final significant new use rules (SNUR) promulgated on October 27, 2014, including one for functionalized carbon nanotubes (generic) (PMN No. P-13-793). EPA states that it received notice of intent to submit adverse comments on the direct final SNURs. EPA intends to publish proposed SNURs for the chemical substances in the notice....

The Center for Food Safety (CFS) filed suit on December 16, 2014, in the U.S. District Court for the District of Columbia against the U.S. Environmental Protection Agency (EPA) over its failure to regulate novel nanomaterial pesticides.  CFS states in its press release that in 2008, it filed a legal petition requesting that EPA regulate nanosilver products as pesticides.  EPA opened a public comment period on November 19, 2008, in response to the petition, but according to...

The U.S. Environmental Protection Agency’s (EPA) Fall 2014 Regulatory Agenda, which was posted on the Office of Management and Budget’s (OMB) website on November 21, 2014, includes an item concerning Section 8(a) Toxic Substances Control Act (TSCA) reporting and recordkeeping requirements for chemical substances when manufactured or processed as nanoscale materials.  According to the item, the proposed rule would require that persons who manufacture these nanoscale materials notify EPA of...

 On November 24, 2014, the U.S. Department of Agriculture (USDA) announced that the U.S. Forest Service (USFS) has released a report that details the pathway to commercializing affordable, renewable, and biodegradable cellulose nanomaterials from trees.  The report, entitled Cellulose Nanomaterials — A Path Towards Commercialization, is the result of a May 2014 workshop that brought together a wide range of experts from industry, academia, and government to ensure that commercialization...

The European Parliament (EP) Committee on Environment, Public Health, and Food Safety (ENVI) has posted a study entitled ENVI Relevant Legislative Areas of the EU-US Trade and Investment Partnership Negotiations (TTIP).  The study analyzes the main differences between European Union (EU) and U.S. legislation in eight areas:  human medicines and medical devices; cosmetics; food and nutrition; sanitary and phyto-sanitary; nanomaterials; cloning; raw materials and energy; and motor...

During the Sustainable Nanotechnology Organization’s (SNO) 2014 Conference, held November 2-4, 2014, in Boston, Massachusetts, Lynn L. Bergeson presented the session “Current Developments in Nanotechnology Law and Policy.” SNO, a non-profit, international professional society dedicated to advancing sustainable nanotechnology through education, research, and promotion of responsible development of nanotechnology, intended the conference to bring together scientific experts from academia,...

The Center for Research on Ingredient Safety (CRIS), which was established at Michigan State University (MSU) in partnership with the Grocery Manufacturers Association in April 2014, will hold its first open house on November 20-21, 2014. Members and prospective members will have the opportunity to meet MSU President Lou Anna K. Simon, hear presentations, and participate in round table discussions. CRIS will be modeled after already existing centers of expertise at other academic...

On October 27, 2014, the U.S. Environmental Protection Agency (EPA) promulgated significant new use rules (SNUR) for 52 chemical substances, including “functionalized carbon nanotubes (generic).” According to the Federal Register notice, the premanufacture notice (PMN) states that the substance will be used as a thin film for electronic device applications. The notice states that, as described in the PMN, EPA “does not expect significant occupational exposures due to the use of...

On October 10, 2014, the Office of Science and Technology Policy (OSTP) announced that the President’s Council of Advisors on Science and Technology (PCAST) released the Report to the President and Congress on the Fifth Assessment of the National Nanotechnology Initiative, which concludes that the nanotechnology community is at an important turning point. PCAST recommends that the federal government accelerate its activities aimed at facilitating the commercialization of federally...

After submitting a proposed rule concerning nanoscale materials to the Office of Management and Budget (OMB) on October 6, 2014, the U.S. Environmental Protection Agency’s (EPA) Spring 2014 Regulatory Agenda item concerning nanoscale materials has been revised. The Regulatory Agenda item posted online in May 2014 referred to the development of a significant new use rule (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) that would require persons who intend to...

On October 6, 2014, the U.S. Environmental Protection Agency (EPA) submitted a proposed rule to the Office of Management and Budget (OMB) entitled “Chemical Substances When Manufactured or Processed as Nanoscale Materials; TSCA Reporting and Recordkeeping Requirements.” The Regulatory Agenda item linked to the proposed rule states that EPA is developing a significant new use rule (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) that would require persons who intend...

Earlier this week, Dr. John Howard, Director of the National Institute for Occupational Safety and Health (NIOSH) announced that, effective October 6, 2014, Chuck Geraci, Ph.D., CIH, has been appointed NIOSH Associate Director for Nanotechnology. NIOSH states: “As Associate Director for Nanotechnology, Dr. Geraci will ensure that NIOSH maintains its outstanding national and international reputation for scientific achievement in the emerging area of nanotechnology implications for workers....

On September 16, 2014, the U.S. Environmental Protection Agency (EPA) published a Federal Register notice announcing the availability of the combined Final 2012 and Preliminary 2014 Effluent Guidelines Program Plans and EPA’s 2012 and 2013 Annual Effluent Guidelines Review Reports. EPA requests comments on its Preliminary 2014 Plan, including the data and information used to support the findings, actions, and conclusions as stated in the Preliminary 2014 Plan. EPA...

On September 16, 2014, the Organization for Economic Cooperation and Development (OECD) published a document entitled Report of the Questionnaire on Regulatory Regimes for Manufactured Nanomaterials 2010-2011. The Report summarizes responses to the Working Party on Manufactured Nanomaterials (WPMN) Questionnaire on Regulated Nanomaterials: 2010-2011, which was issued July 12, 2012. The Questionnaire contained four sections related to the oversight of nanomaterials in various OECD...

On September 2, 2014, the U.S. Environmental Protection Agency (EPA) promulgated final significant new use rules (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 36 chemical substances that were the subject of premanufacture notices (PMN). The substances include multi-walled carbon nanotube (generic) (P-08-0392), multi-wall carbon nanotubes (generic) (P-09-257), multi-walled carbon nanofibers (generic) (PMNs P-10-115, P-10-116, P-10-117, P-10-118, P-10-119,...

The National Institute for Occupational Safety and Health (NIOSH) announced in its September 5, 2014, eNews that an international committee unanimously selected Dr. Vladimir Murashov, special assistant for nanotechnology to the NIOSH Director, “to lead an international working group on the health, safety, and environmental aspects of nanotechnologies.”  NIOSH states that the working group is part of a larger initiative by the International Organization for Standardization...

The National Nanotechnology Coordination Office, on behalf of the Nanoscale Science, Engineering, and Technology Subcommittee of the Committee on Technology, National Science and Technology Council, will hold a workshop entitled “Sensor Fabrication, Integration, and Commercialization” on September 11-12, 2014.  According to the August 7, 2014, Federal Register notice announcing the workshop, it will bring together experts from a wide-range of application areas, stages of product...

On July 29, 2014, the House Energy and Commerce Subcommittee on Commerce, Manufacturing, and Trade held a hearing on “Nanotechnology:  Understanding How Small Solutions Drive Big Innovation.” Witnesses included: Subcommittee Chair Lee Terry stated that “nanotechnology is poised to drive the next surge of economic growth across all sectors.” According to Dr. Binek, nanotechnology has the potential to transform a range of industries, in fields such as information technology,...

On July 29, 2014, the Office of Science and Technology Policy (OSTP) and the National Economic Council (NEC) published a Federal Register notice requesting public comments to provide input for an upcoming update of the Strategy for American Innovation. According to the notice, the Strategy “helps to guide the Administration’s efforts to promote lasting economic growth and competitiveness through policies that support transformative American innovation in products,...

On July 31, 2014, the National Nanotechnology Coordination Office (NNCO) will hold a public webinar to provide a forum to answer questions related to the federal government’s “Progress Review on the Coordinated Implementation of the National Nanotechnology Initiative 2011 Environmental, Health, and Safety Research Strategy.” According to the July 22, 2014, Federal Register notice, discussion will focus on the research activities undertaken by the National Nanotechnology Initiative...

The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) published a Federal Register notice on June 19, 2014, requesting available data and information on devices and/or technologies currently used for identifying potential inhalation hazards. According to NICEATM, it will use submitted information “to determine the technical requirements for developing effective inhalation toxicity tools to assess potential chemical or...

Registration is now open for Nano Risk Analysis (II), a workshop to explore how a multiple models approach can advance risk analysis of nanoscale materials. The workshop, which is being organized by the Emerging Nanoscale Materials Specialty Group (ENMSG) of the Society for Risk Analysis (SRA) and co-sponsored by Bergeson & Campbell, P.C., will be held September 15-16, 2014, in Washington, D.C. The workshop will bring together experts from diverse disciplines to explore ways that...

On July 8, 2014, the U.S. Environmental Protection Agency (EPA) promulgated significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 13 chemical substances that were the subject of premanufacture notices (PMN). The rule includes two PMN substances, P-10-5 and P-11-339, that were the subject of TSCA Section 5(e) consent orders and whose reported chemical names include the term “carbon nanotube” (CNT) or “CNT.” EPA states that, because of a lack of...

On June 24, 2014, the U.S. Food and Drug Administration (FDA) issued three final guidances and one draft guidance that it intends to provide “greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products.” One final guidance addresses FDA’s overall approach for all products that it regulates, while the two additional final guidances and the new draft guidance provide specific guidance for the areas of foods, cosmetics, and food for animals,...

Last month, the National Institute for Occupational Safety and Health (NIOSH) released a report entitled The State of the National Initiative on Prevention through Design, which provides an overview of the progress and accomplishments of the Prevention through Design (PtD) initiative. The ultimate goal is to prevent or reduce occupational injuries, illnesses, or fatalities through the inclusion of prevention considerations into all designs that might impact workers. According to the report,...

The House Science, Space, and Technology Subcommittee on Research and Technology will hold a hearing on May 20, 2014, on “Nanotechnology:  From Laboratories to Commercial Products.” Scheduled witnesses include: The hearing will be webcast live....

The U.S. Environmental Protection Agency (EPA) has awarded a $5 million, four-year grant to investigators led by Arizona State University to study the life cycle of nanomaterials. According to EPA’s description of the award, the project involves an interdisciplinary team of chemists, toxicologists, scientists, engineers, and social scientists to evaluate the trade-offs between intended function of nanomaterials in products and risks to humans and the environment across their life...

On March 31, 2014, the U.S. Environmental Protection Agency (EPA) announced that it issued an order to Pathway Investment Corp. of Englewood, New Jersey to stop the sale of plastic food storage containers that have not been tested or registered with EPA, in violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). According to EPA’s press release, the company’s Kinetic Go Green Premium Food Storage Containers and Kinetic Smartwist Series Containers contain...

On March 25, 2014, the National Nanotechnology Initiative (NNI) published a supplement to President Obama’s 2015 budget request submitted to Congress on March 4, 2014.  The supplement provides a description of the activities underway in 2013 and 2014 and planned for 2015 by the federal government agencies participating in the NNI, primarily from a programmatic and budgetary perspective.  NNI states that it is based on the NNI Strategic Plan and reports actual investments...

On March 6, 2014, Representative Eddie Bernice Johnson (D-TX), Ranking Member of the Committee on Science, Space, and Technology, introduced the America Competes Reauthorization Act of 2014 (H.R. 4159). The bill would establish, revise, and extend specified science, technology, engineering, and mathematics programs, as well as education, research, and training programs.  The bill would reauthorize the National Nanotechnology Initiative (NNI) “to ensure the United States remains a leader in...

On February 25, 2014, the National Science Foundation (NSF) announced the results of an NSF and National Nanotechnology Coordination Office (NNCO)-funded independent study that identifies more than $1 trillion in global revenue from nano-enabled products in 2013. NSF states that, to help quantify the global growth in nanotechnology research and development, Lux Research released a new report on global spending for emerging nanotechnology and the next generation of nano-enabled...

On February 28, 2014, the National Nanotechnology Coordination Office (NNCO) announced the release of the 2014 National Nanotechnology Initiative (NNI) Strategic Plan.  The NNI Strategic Plan represents the consensus of the participating agencies as to the high-level goals and priorities of the NNI and specific objectives for at least the next three years.  It is intended to provide an integrated, interagency approach informing the nanotechnology-specific strategic plans of NNI...

On February 12, 2014, the U.S. Environmental Protection Agency (EPA) issued, through a direct final rule, significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 35 chemical substances that were the subject of premanufacture notices (PMN). The 35 substances include four identified as multi-walled carbon nanotubes (generic) that were the subject of a December 3, 2012, TSCA Section 5(e) consent order. The consent order requires the use of personal protective equipment...

On February 7, 2014, the U.S. Government Accountability Office (GAO) released a report entitled Nanomanufacturing: Emergence and Implications for U.S. Competitiveness, the Environment, and Human Health, which provides highlights from a Congressionally-requested forum on specific issues in nanotechnology manufacturing that was held July 23-24, 2013. The House Committee on Science, Space, and Technology asked the GAO and the National Academies to convene the forum and elicit the...

On December 7, 2013, the Journal of Nanoparticle Research published online an article entitled “Occupational safety and health criteria for responsible development of nanotechnology.” The authors, who are affiliated with the National Institute for Occupational Safety and Health (NIOSH), describe five criterion actions that they believe should be practiced by decision-makers to ensure the responsible development of nanotechnology: “(1) anticipate, identify, and track potentially...

On December 2-3, 2013, the U.S.-EU Communities of Research held a workshop intended to further develop and support their activities. The goal of the workshop was to publicize progress towards their goals and objectives, clarify and communicate future plans, share best practices, and identify areas of cross-Community collaboration. Participants included American and European scientists and policy makers from academia, research institutes, industry, and governments. The presentations...

On December 20, 2013, the National Institute for Occupational Safety and Health (NIOSH) published a document entitled Protecting the Nanotechnology Workforce: NIOSH Nanotechnology Research and Guidance Strategic Plan, 2013-2016. NIOSH describes the document as “the roadmap being used to advance basic understanding of the toxicology and workplace exposures involved so that appropriate risk management practices can be implemented during discovery, development, and...