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On the 7th March 2011, the US National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention announced that it sought comments and information on the types of hazard identification and risk management research that it should consider in updating the NIOSH 2009 nanotechnology strategic plan. What follows is an explanation of why NIOSH's continuing research is essential, and why stakeholders are urged to help shape the content and direction of the research NIOSH undertakes in this critically important area.
NIOSH's Core Mission
NIOSH is the federal agency in the United States responsible for conducting research and making recommendations for the prevention of work-related injury and illness. NIOSH is not a regulatory agency. Occupational safety and health rules are issued and enforced by the U.S. Occupational Safety and Health Administration. NIOSH maintains an extensive and helpful website. There is much information on the site specific to manufactured nanoscale materials and preventative measures applicable to work environments.
Since 2004, NIOSH has maintained a leadership role in researching the toxicological properties and characteristics of manufactured nanoscale materials and particles, characterizing and predicting whether these materials may pose a risk of adverse health effects in the work environment, and identifying practical and helpful measures to abate any such risks in the workplace. Among the many valuable contributions to the growing body of information on ensuring a safe nanotechnology workplace is NIOSH's Approaches To Safe Nanotechnology. The document was originally published in draft in 2004, and a revised draft was issued in 2006.
In 2009, NIOSH released an updated document in which NIOSH reiterates its standing interim recommendation that employers take prudent measures to control occupational exposures in the manufacture and industrial use of engineered nanomaterials and to keep in step with research advances for determining if such materials are likely to pose work-related health and safety risks. The updated document reflects new scientific findings from ongoing research that have been published in the peer-reviewed scientific literature since the last revised draft version of Approaches was issued in 2006.
This information includes findings from NIOSH's own strategic research program, as well as research by scientific partners from the United States and abroad. The revised document includes an expanded section on risk management, with a detailed discussion of factors that may affect occupational exposure to engineered nanomaterials, and expanded interim recommendations for controlling work-related exposures, and an expanded discussion of exposure assessment and characterization for engineered nanomaterials, including a new summary table of instruments and measurement methods used in the evaluation of nanomaterial exposures.
An important part of NIOSH's core mission is to direct research that will support its ability to achieve its goals and objectives. In soliciting public comment on the types of research that will best enhance NIOSH's ability to identify workplace hazards and suggest practical ways to mitigate them, NIOSH expressed its interest in building on the accomplishments of its ongoing research that has enabled it to issue and regularly update the Approaches document and to develop strategic research goals and objectives through 2015.
NIOSH specifically identified ten critical research areas specific to nanotechnology research and communication:
1. toxicity and internal dose;
2. measurement methods;
3. exposure assessment;
4. epidemiology and surveillance;
5. risk assessment;
6. engineering controls and personal protective equipment (PPE);
7. fire and explosion safety;
8. recommendations and guidance;
9. communication and information; and
NIOSH states that it is considering focusing the overarching strategic research goals for these critical areas on five key goals:
* Provide guidance to protect workers;
* Alert workers, employers, governments, and the public about possible new hazards;
* Assess the hazards of nanomaterials and the risks to workers;
* Help workers by assessing and implementing exposure registries; and
* Assess the level of protection practiced in U.S. workplaces.
NIOSH requests comment on how research in the ten critical areas and five overarching goals can be enhanced. Examples of requested information include the need for toxicity evaluation and/or workplace exposure characterization of engineered nanoparticles not currently being studied; development of technical and educational guidance materials; development of additional partnerships and collaborations; and research in the development of risk management strategies. Comments are due April 15, 2011.
Why Comment Is Critically Important
As noted, NIOSH's contributions to the growing body of information on identifying and managing workplace hazards potentially associated with the presence of manufactured nanoscale particles and materials in the work environment have been invaluable. As a private legal practitioner often counseling nano startups as well as mature, large manufacturers on regulatory and business strategies intended to commercialize nanotechnology safely, NIOSH's Approaches to Safe Nanotechnology is one resource routinely recommended as it provides useful, practical, and current information on a wide range of topics directly relevant to engineered nanoscale material manufacturers, processors, and users.
To the extent NIOSH can be directed to focus its current and future research on areas most critically needed for the manufacturing sector, the information the business sector needs to identify more precisely and manage more effectively potential workplace hazards derivative of manufactured nanoscale materials and particles will be aided considerably. This, in turn, will position NIOSH to be an even more effective resource for the nano community and thus assist in realizing the safe commercialization of nanotechnologies.
About Bergeson & Campbell, P.C.
Bergeson & Campbell, P.C. is a Washington, D.C. law firm focusing on assisting clients in obtaining regulatory agency approval of their chemical, medical device, and diagnostic products, as well as on the product approval and regulation, product defense, and business issues associated with those products. We represent and counsel individuals, business entities, trade associations, and industry coalitions. Our fundamental goals are to solve our clients` existing problems, and to minimize future difficulties. Reliance on only a single set of skills often is not enough.
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