Nano and Other Emerging Technologies Blog

Federal Advisory Council on Occupational Safety and Health Considers Dispersible Engineered Nanomaterials

Lynn L. Bergeson — Fri, 18 May 2012 15:26:15 -0500

The Federal Advisory Council on Occupational Safety and Health (FACOSH) met on May 3, 2012, during which it discussed the use of occupational exposure levels (OEL) by the federal government. Because the Occupational Safety and Health Administration’s (OSHA) permissible exposure limits (PEL) have remained unchanged since their adoption on May 29, 1971, and do not account for advances in technology or the latest data, FACOSH asked its Emerging Issues Subcommittee to analyze federal agencies’ use of PELs. As part of its review, the Subcommittee identified other issues of interest, including dispersible engineered nanomaterials (DENM). A document entitled “Recommendations for Consideration by the U.S. Secretary of Labor on the Adoption and Use of Occupational Exposure Limits by Federal Agencies” includes the following text concerning DENMs:

OSHA defines nanomaterials as, “materials that have been purposefully manufactured, synthesized, or manipulated to have a size with at least one dimension in the range of approximately 1 to 100 nanometers and that exhibit unique properties determined by their size.”
Published scientific studies have indicated that at least some DENMs are biologically active, have produced toxicological reactions in the lungs of exposed experimental animals, and may readily penetrate intact human skin. While DENMs are truly an emerging issue and published results are not plentiful, scientists and federal agencies, such as NIOSH, continue to conduct research to understand fully the potential health effects of exposure.
Currently, both scientists and federal agencies agree that DENM toxicity depends heavily on the physical and chemical properties of the nanoparticles, such as particle size and size distribution, agglomeration state, shape, crystal structure, chemical composition, surface area, surface chemistry, surface charge, and porosity, and that these properties may differ substantially from those of the same material in macro-scale form.

EU Biocides Regulation Addresses Nanomaterials

Lynn L. Bergeson — Thu, 17 May 2012 17:30:53 -0500

On May 10, 2012, the Council of the European Union (EU) announced the adoption of a regulation concerning the placing on the market and use of biocidal products, which include insecticides, disinfectants, and repellents, but not medicines or agricultural pesticides. The regulation will take effect September 1, 2013, with a transitional period for certain provisions. The regulation incorporates the European Commission’s (EC) recommendation on the definition of a nanomaterial, and requires that, where nanomaterials are used in a product, the risk to the environment and to health be assessed separately. Labels would be required to include the name of all nanomaterials contained in biocidal products, followed by the word “nano” in brackets. The regulation states that “approval of an active substance shall not cover nanomaterials except where explicitly mentioned.”

U.S. Delegation May Present Nanotechnology Guidance at UN GHS Subcommittee Meeting

Lynn L. Bergeson — Wed, 16 May 2012 18:11:53 -0500

The U.S. delegation to the July 4-6, 2012, meeting of the United Nations (UN) Subcommittee of Experts on the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) is considering presenting an information paper on how to classify nanomaterials under the GHS. According to Kathy Landkrohn, Occupational Safety and Health Administration (OSHA) Directorate of Standards and Guidance, the paper would be presented under a work group examining the types of physical and chemical properties listed on safety data sheets (SDS). Landkrohn stated that a lack of data has impeded the work group’s ability to create a separate hazard class for nanomaterials.

EPA Releases Roadmap on Technology Innovation for Environmental and Economic Progress

Lynn L. Bergeson — Tue, 15 May 2012 17:13:47 -0500

On May 14, 2012, the U.S. Environmental Protection Agency (EPA) and the Department of Commerce announced efforts to launch an environmental technology initiative intended to help create American jobs in the growing environmental industry. EPA released a document entitled Technology Innovation for Environmental and Economic Progress: An EPA Roadmap, which states that EPA “will undertake policy, regulatory, financial, and voluntary actions, grounded in science, that will promote innovation along the entire continuum of technology development and deployment.” Specifically, according to the Roadmap, EPA “will advocate more cost-effective, innovative solutions that eliminate, or significantly reduce, adverse impacts to natural resources in a manner that promotes healthy, productive communities.” EPA states that its initial efforts will focus on four broad actions:

Designing EPA policies, regulations, standards, permits, and procedures to leverage technology innovation;
Catalyzing technology design, development, finance, commercialization, and adoption through partnerships with stakeholders;
Stimulating cross-Agency consideration, development, commercialization, and adoption of breakthrough technologies; and
Developing a new relationship with the investment community. EPA will take a number of steps to build relationships and improve communication.

NNI Agencies Announce New Nanotechnology Signature Initiative

Lynn L. Bergeson — Mon, 14 May 2012 14:51:52 -0500

On May 14, 2012, the agencies participating in the National Nanotechnology Initiative (NNI) announced the fourth Nanotechnology Signature Initiative, “Nanotechnology Knowledge Infrastructure: Enabling National Leadership in Sustainable Design” (NKI). According to a press release issued by the National Nanotechnology Coordination Office (NNCO), this signature initiative will stimulate the development of models, simulation tools, and databases to enable the prediction of specific properties and characteristics of nanoscale materials. This will then accelerate commercialization of nanotechnology innovations that maximize benefits to humans and the environment while minimizing risks. NKI identifies four areas that will benefit from focused attention:

A diverse collaborative community of scientists, engineers, and technical staff to support research, development, and applications of nanotechnology to meet national challenges;
An agile modeling network for multidisciplinary intellectual collaboration that effectively couples experimental basic research, modeling, and applications development;
A sustainable cyber-toolbox to enable effective application of models and knowledge to nanomaterials design; and
A robust digital nanotechnology data and information infrastructure to support effective data sharing, collaboration, and innovation across disciplines and applications.

SAICM Will Publish Comments on Adding Nanotechnology Activities to Global Plan of Action

Lynn L. Bergeson — Thu, 10 May 2012 17:29:55 -0500

The Strategic Approach to International Chemicals Management (SAICM) Secretariat is expected to publish this month comments on Switzerland’s proposal that activities relating to nanotechnology be added to the SAICM Global Plan of Action. The proposal would include a new work area on nanotechnologies and manufactured nanomaterials, with corresponding activities, actors, and targets. The Secretariat will compile the comments to inform discussion at the third International Conference on Chemicals Management (ICCM3), which will be held September 17-21, 2012. The Nanotechnology Industries Association (NIA) submitted detailed comments on the proposal.

CRS Publishes Nanotechnology Policy Primer

Lynn L. Bergeson — Mon, 07 May 2012 14:30:29 -0500

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. CRS states that, since the launch of the National Nanotechnology Initiative (NNI) in 2000 through fiscal year (FY) 2012, Congress has appropriated approximately $15.6 billion for nanotechnology R&D, including approximately $1.7 billion in FY 2012. President Obama has requested $1.8 billion in NNI funding for FY 2013. More than 60 nations have established similar programs, and, according to CRS, in 2010, the total global public R&D investments were approximately $8.2 billion, complemented by an estimated private sector investment of $9.6 billion. Based on the data on inputs (e.g., R&D expenditures) and non-financial outputs (e.g., scientific papers, patents), the U.S. appears to be the overall global leader in nanotechnology, though CRS cautions that some believe the U.S. lead “may not be as large as it was for previous emerging technologies.” According to CRS, some research has raised concerns about the safety of nanoscale materials, and “[t]here is general agreement that more information on EHS implications is needed to protect the public and the environment; to assess and manage risks; and to create a regulatory environment that fosters prudent investment in nanotechnology-related innovation.”

EO on Promoting International Regulatory Cooperation Includes Emerging Technology

Lynn L. Bergeson — Fri, 04 May 2012 18:20:09 -0500

On May 1, 2012, President Barack Obama signed an Executive Order (EO) entitled “Promoting International Regulatory Cooperation,” which is intended to ensure that differing regulatory approaches taken by foreign governments do not unnecessarily limit the ability of American businesses to export and compete internationally. EO 13563, which Obama signed on January 18, 2011, states that the U.S. regulatory system must protect public health, welfare, safety, and the environment while promoting economic growth, innovation, competitiveness, and job creation. The May 1, 2012, EO calls for the Regulatory Working Group established by Executive Order 12866, and reaffirmed by EO 13563, to serve as a forum to discuss, coordinate, and develop a common understanding among agencies of U.S. government positions and priorities with respect to: international regulatory cooperation activities that are reasonably anticipated to lead to significant regulatory actions; efforts across the federal government to support significant, cross-cutting international regulatory cooperation activities; and promotion of good regulatory practices internationally, as well as the promotion of U.S. regulatory approaches, as appropriate.

Of significance to nanotechnology stakeholders, the EO calls for the Regulatory Working Group to examine appropriate strategies for engaging in the development of regulatory approaches through international regulatory cooperation, “particularly in emerging technology areas.” The Chair of the Regulatory Working Group is Cass R. Sunstein, Administrator of the Office of Information and Regulatory Affairs (OIRA) of the Office of Management and Budget (OMB). Sunstein wrote a May 1, 2012, blog item on the EO, and requested comments on how to “reduce red tape and unjustified costs by increasing regulatory cooperation, in North America and beyond.”

Bill to Provide Tax Credits for Renewable Chemicals Introduced in the House

Lynn L. Bergeson — Thu, 03 May 2012 15:04:35 -0500

Representatives Bill Pascrell, Jr. (D-NJ) and Brian Bilbray (R-CA) introduced on April 26, 2012, the Qualifying Renewable Chemical Production Tax Credit Act of 2012 (H.R. 4953), which would amend the Internal Revenue Code to provide a credit for the production of renewable chemicals. The credit would be equal to $0.15 per pound of eligible content of renewable chemical produced during the taxable year. Eligible content would mean the biobased content percentage of the total mass of organic carbon in such chemical. Renewable chemical would mean any chemical produced in the U.S. from renewable biomass that is sold or used for the production of polymers, plastics, or formulated products, or as polymers, plastics, or formulated products, and is not sold or used for the production of any food, feed, or fuel. Chemicals would be excluded if the biobased content percentage is less than 25 percent; 10,000,000 pounds or more of such chemical was produced in 2000 from renewable biomass; the chemical is neither the product of nor reliant upon, biological conversion, thermal conversion, or a combination of biological and thermal conversion, of renewable biomass; or the chemical is composed of renewable chemicals that are eligible for a credit under the bill. The total number of credits under the program would be limited to $500,000,000, and no taxpayer may receive more than $25,000,000 in any taxable year. The program would end five years after the date of enactment of the bill. The bill was referred to the House Committee on Ways and Means.

ECHA Announces Updated Guidance for Registering Nanomaterials

Lynn L. Bergeson — Wed, 02 May 2012 13:18:52 -0500

On April 30, 2012, the European Chemicals Agency (ECHA) announced the availability of three appendices, updating Chapters R.7a, R.7b, and R.7c of the Guidance on Information Requirements and Chemical Safety Assessment (IR & CSA). ECHA prepared a draft revision of the Guidance, based on the outcome of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Implementation Projects on Nanomaterials (RIP-oN) 2 final report. ECHA updated the Guidance via a fast-track procedure, and states that this was justified on the basis that the final RIP-oN 2 report had already been the subject of consultation with relevant stakeholders. Its content could, therefore, be considered as reflecting a consensus. Furthermore, according to ECHA, the update “needed to be made urgently in order to allow publication of the guidance as soon as possible and well in advance of the next REACH registration deadline,” May 30, 2013. The updated Guidance provides tailored advice to prepare registrations for substances in the nanoform.

PCAST Releases Fourth Assessment of the NNI

Lynn L. Bergeson — Tue, 01 May 2012 11:52:29 -0500

On April 27, 2012, the President’s Council of Advisors on Science and Technology (PCAST) released the Report to the President and Congress on the Fourth Assessment of the National Nanotechnology Initiative, which is a Congressionally mandated biennial review of the National Nanotechnology Initiative (NNI). PCAST found that the NNI, which has provided $16 billion to date in investments by 26 federal agencies, “has had a ‘catalytic and substantial impact’ on the growth of the U.S. nanotechnology industry and should be continued.” PCAST states that, in large part due to the NNI, the U.S. “is today, by a wide range of measures, the global leader in this exciting and economically promising field of research and technological development.” The Obama Administration has proposed $1.8 billion in funding for fiscal year 2013 for 15 agencies with budgets dedicated to nanotechnology research and development (R&D).

According to the report, the federal agencies in the NNI made substantial progress in addressing many of PCAST’s 2010 recommendations that were aimed at maintaining U.S. leadership in nanotechnology. The Office of Science and Technology Policy (OSTP) states that one of NNI’s primary goals “is to stay ahead of heavily-investing competitors such as China, South Korea, the European Union, and Russia.” PCAST found that the U.S. federal government “continues to invest more in nanotechnology R&D than any other single country.” Overall, PCAST concluded that the NNI remains a successful cooperative venture that is supporting high-quality research, facilitating the translation of discoveries into new commercial products, and ensuring the Nation’s continued global leadership in this important field. PCAST “applauds the increased efforts of the National Nanotechnology Coordinating Office [(NNCO)] in the area of commercialization and coordination with industry and in the release of a focused research strategy for addressing environmental, health, and safety (EHS) implications of nanotechnology.”

PCAST noted that additional efforts are needed in four areas: strategic planning; program management; metrics for assessing impact; and increasing support for research on EHS issues associated with nanotechnology. According to PCAST, continued lack of attention to these concerns will make it harder for the U.S. to maintain its leadership role in the commercialization of nanotechnology.

Obama Administration Releases National Bioeconomy Blueprint

Lynn L. Bergeson — Mon, 30 Apr 2012 11:25:00 -0500

On April 26, 2012, the Obama Administration released its National Bioeconomy Blueprint, which is intended to provide a comprehensive approach to harnessing innovations in biological research to address national challenges in health, food, energy, and the environment. In coordination with the release of the National Bioeconomy Blueprint, the Secretary of Health and Human Services Kathleen Sebelius and the Secretary of Agriculture Tom Vilsack announced commitments supportive of the Blueprint’s goals. These include initiatives to encourage federal procurement of an expanded range of biobased products; take better advantage of large pharmaceutical data sets to speed drug development; apply the latest genomics discoveries to identify quickly emerging microbial threats; and accelerate research on non-embryonic stem cells as possible treatments for blood-related and neurological diseases.

The National Bioeconomy Blueprint identifies the following five strategic objectives intended “to enable a vibrant U.S. bioeconomy in the years and decades ahead, with potential to deliver major economic and social benefits”:

Support research and development investments that will provide the foundation for the future bioeconomy;
Facilitate the transition of bioinventions from research lab to market, including an increased focus on translational and regulatory sciences;
Develop and reform regulations to reduce barriers, increase the speed and predictability of regulatory processes, and reduce costs while protecting human and environmental health;
Update training programs and align academic institution incentives with student training for national workforce needs; and
Identify and support opportunities for the development of public-private partnerships and precompetitive collaborations -- where competitors pool resources, knowledge, and expertise to learn from successes and failures.

Amended Federal Regulation Will Require Contractors to Report Purchase of Biobased Products

Lynn L. Bergeson — Mon, 23 Apr 2012 12:44:41 -0500

On April 18, 2012, the United States Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA) promulgated a final rule amending the Federal Acquisition Regulation (FAR) to implement changes due to the Farm Security and Rural Investment Act that require contractors to report the biobased products purchased under service and construction contracts. According to the Federal Register notice, the reporting will enable agencies to monitor compliance with the federal preference for purchasing biobased products. The information reported by prime contractors will enable federal agencies to report annually information concerning actions taken to implement the preference for biobased products, and assess compliance and measure progress in carrying out the preference for biobased products. Where information on the biobased nature of products is not already available, the notice states that contractors may need to create an inventory management system to track the product types and dollar value of United States Department of Agriculture (USDA)-designated biobased products purchased for each contract. DoD, GSA, and NASA expect that the impact will be minimal, however, because the existing clause already requires contractors to make maximum use of biobased products. The final rule will be effective May 18, 2012.

FDA Releases Draft Guidance Documents on Nanomaterials

Lynn L. Bergeson — Fri, 20 Apr 2012 17:06:00 -0500

On April 20, 2012, the U.S. Food and Drug Administration (FDA) announced the availability of two draft guidance documents addressing the use of nanotechnology, “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.” FDA states that the food draft guidance describes factors manufacturers should consider when determining whether changes in manufacturing processes, including those involving nanotechnology, create a significant change that may:

Affect the identity of the food substance;
Affect the safety of the use of the food substance;
Affect the regulatory status of the use of the food substance; or
Warrant a regulatory submission to FDA.

The cosmetic product draft guidance discusses the FDA’s current thinking on the safety assessment of nanomaterials when used in cosmetic products. Key points include:

The legal requirements for cosmetics manufactured using nanomaterials are the same as those for any other cosmetics. While cosmetics are not subject to premarket approval, companies and individuals who market cosmetics are legally responsible for the safety of their products and they must be properly labeled; and
To conduct safety assessments for cosmetic products containing nanomaterials, standard safety tests may need to be modified or new methods developed.

FDA notes that both guidance documents encourage manufacturers to consult with it before taking their products to market. According to FDA, this consultation can help FDA experts address questions related to the safety or other attributes of nanotechnology products, or answer questions about their regulatory status. Comments will be due 90 days after FDA announces their availability in the Federal Register.

ECHA Forwards Draft Guidance Concerning Nanomaterials to CARACAL

Lynn L. Bergeson — Wed, 18 Apr 2012 16:49:34 -0500

The European Chemicals Agency (ECHA) sent three new draft appendices to Chapters R.8, R.10, and R.14 of the guidance on information requirements and chemical safety assessment concerning recommendations for nanomaterials to the Competent Authorities for Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and Classification, Labeling, and Packaging (CLP) (CARACAL). The draft appendices are based on the results of the REACH Implementation Project on Nanomaterials (RIPoN). The draft appendices are available at:

EU OSHA Announces French Report on Feasibility of Epidemiological Surveillance System for Workers Exposed to Engineered Nanomaterials

Lynn L. Bergeson — Tue, 17 Apr 2012 18:47:17 -0500

The European Agency for Safety and Health at Work (EU OSHA) posted an item on April 16, 2012, concerning a French report on the feasibility of an epidemiological surveillance system for workers exposed to engineered nanomaterials. EU OSHA notes that the French Health and Occupational Ministries asked the French Institute for Public Health Surveillance (InVS), supported by a multidisciplinary working group convened by the Institute for Public Health Research, to assess the feasibility of an epidemiological surveillance system of workers likely to be exposed to engineered nanomaterials. The resulting report “draws up an inventory of the numerous uncertainties inherent to this field such as the question of definition, the wide range of nanomaterials, the identification of health events that could be monitored, the registration and collaboration of companies and workers likely to be concerned by nanomaterials and the metrological issues.” According to EU OSHA, InVS suggests the implementation of a double surveillance system with a prospective cohort study and repeated cross-sectional studies. The repeated cross-sectional studies would include all kinds of nanomaterials, while the cohort study would focus on a few. In conclusion, EU OHSA states, the report gives some recommendations for epidemiological research. While the French report is dated 2011, an English summary is dated 2012.

OECD Publishes New Document in Series on Safety of Manufactured Nanomaterials

Lynn L. Bergeson — Mon, 16 Apr 2012 17:33:21 -0500

The Organization for Economic Cooperation and Development (OECD) recently published a new document in its series on the safety of manufactured nanomaterials, Important Issues on Risk Assessment of Manufactured Nanomaterials. The document was prepared by Steering Group Six of the Working Party on Manufactured Nanomaterials (WPMN), which is leading the project on cooperation on risk assessment, and was endorsed at the ninth meeting of the WPMN in December 2011. The document provides the current practices, challenges, and strategies for assessing risk in circumstances where data are limited, and there is a necessity for more research on specific risk assessment issues. OECD cautions that it is not to be construed to imply scientific and/or policy endorsement of any specific risk assessment methods or models, however. OECD notes that “this document is a living document,” and was current at the time of WPMN’s ninth meeting in December 2011. The document is subject to amendment and refinement as research affords further understanding of how to assess and manage nanomaterials.

USDA Amends Guidelines for Designating Biobased Products for Federal Procurement

Lynn L. Bergeson — Wed, 11 Apr 2012 16:44:23 -0500

In an April 4, 2012, final rule, the U.S. Department of Agriculture (USDA) amended the Guidelines for Designating Biobased Products for Federal Procurement to add 13 sections to designate product categories within which biobased products will be afforded federal procurement preference. USDA also established minimum biobased contents for each of these product categories. The 13 categories are: air fresheners and deodorizers; asphalt and tar removers; asphalt restorers; blast media; candles and wax melts; electronic components cleaners; floor coverings (non-carpet); foot care products; furniture cleaners and protectors; inks; packing and insulating materials; pneumatic equipment lubricants; and wood and concrete stains. USDA has determined that each of these product categories meets the necessary statutory requirements; that they are being produced with biobased products; and that their procurement will carry out the following objectives of Section 9002 of the Farm Security and Rural Investment Act of 2002, as amended by the Food, Conservation, and Energy Act of 2008: to improve demand for biobased products; to spur development of the industrial base through value-added agricultural processing and manufacturing in rural communities; and to enhance the nation’s energy security by substituting biobased products for products derived from imported oil and natural gas. With the designation of these specific product categories, USDA invites the manufacturers and vendors of qualifying products to provide information on the product, contacts, and performance testing for posting on its BioPreferred website. The final rule will be effective May 4, 2012.

EC Scientific Committee Requests Information on Nanosilver

Lynn L. Bergeson — Tue, 10 Apr 2012 17:09:22 -0500

On April 10, 2012, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) invited interested parties to submit any relevant information that could assist it with its assessment of the safety, health, and environmental effects of nanosilver. In particular, SCENIHR states, it is interested in receiving any scientific information related to the “nano” forms of silver. The EC requested on December 9, 2011, that SCENIHR prepare a scientific opinion on the safety, health, and environmental effects and role in antimicrobial resistance of nanosilver. The EC requested SCENIHR “to assess whether the use of nanosilver, in particular in medical care and in consumer products could result in additional risks compared to more traditional uses of silver,” and “to assess whether the use of nanosilver to control bacterial growth could result in resistance of micro-organisms.” The deadline for SCENIHR’s opinion is early 2013. All information submitted to SCENIHR is considered public unless otherwise stated by the provider. Information is due to SCENIHR by June 4, 2012.

B&C and Acta Will Hold an OSHA GHS Webinar

Lynn L. Bergeson — Thu, 05 Apr 2012 13:52:17 -0500

Bergeson & Campbell, P.C. (B&C) and The Acta Group, L.L.C. (Acta) will hold a complimentary webinar on April 18, 2012, from 1:30 to 3:30 p.m. (EDT) on the Occupational Safety and Health Administration's (OSHA) final rule revising the OSHA Hazard Communication Standard (HCS) issued on March 26, 2012. The final rule aligns the HCS with the United Nations' Globally Harmonized System for Chemical Classification and Labeling (GHS). OSHA estimates the rule is expected to impact some five million U.S. workplaces and have an annual cost of approximately $97 million.

The webinar will address the major changes to the HCS, including a general overview, revisions to hazard categories, training/information requirements, safety data sheet (SDS) modifications, and label requirements. It will also compare the revised HCS to global GHS adoption schemes. A question and answer session will follow. More specific detail oriented webinars will be provided as a follow-up. Speakers include:

Lynn L. Bergeson;
Andrew R. Bourne;
Lisa R. Burchi; and
Leslie S. MacDougall.

Lynn L. Bergeson will moderate the program.

The agenda and speaker profiles are available online. The RSVP deadline is April 16, 2012.

Attendees are urged to review the B&C Clients and Friends memorandum on OSHA's final GHS rule. OSHA's final rule and related information are available online.