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As nanotechnology becomes more prevalent, especially when used in consumer products, various government agencies across the globe are becoming involved in either promoting nanotechnology R&D or finding ways to apply regulations to ensure it is used safely.  For the most part, environmental protection agencies in the US, Canada, EU, Japan and several other countries are the most active regulators of nanotechnology.  Below are links to and brief comments on the government agencies most active in nanotechnology.

In all cases, nanoTox is familiar with the current regulatory requirements of the major regulatory agencies and can help clients with compliance requirements to facilitate nanotechnology commercialization.

United States
U.S. Environmental Protections Agency (EPA)
US EPA is applying rules under the Toxic Substance Control Act (TSCA) to regulate nano-materials.  If a nano scale material is deemed a ‘significant new use’, EPA issues a significant new use rule (SNUR), asks for a significant new use notice (SNUN) and may require a pre-manufacturing notice (PMN) before allowing a manufacturer to ship their nano scale product.

nanoTox has the capabilities to issue the SNUN or PMN as required by EPA as well as do any follow up testing that the EPA may require before approving the nano scale material.  nanoTox can also help with Material Safety Data Sheets for products containing nano scale materials.
http://www.epa.gov/oppt/nano/nano-facts.htm

U.S. Food and Drug Administration

http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/default.htm

Nano Pharmaceuticals
All drugs sold in the U.S. must pass stringent testing and safety protocols as established by the FDA.  The FDA makes no distinction as to nano scale versus normal scale in its requirements for safe and effective pharmaceuticals or for the testing protocols and regimens required for approval.  There are more than 15 approved pharmaceuticals that can be classified as nano scale by the nature of the drug’s size.

Nano scale drugs have exciting possibilities for treatments for cancer and other diseases and conditions.  nanoTox scientists include board certified toxicologists (D.A.B.T. designation) that have long experience with the FDA protocols for drug testing and approval.  With this experience we can design and manage the proper cost effective GLP quality testing protocols required by FDA.  We can help avoid unwanted and costly repetitions for tests and if consulted early in the R&D stages, may even be able to provide experience to avoid possible safety issues for new nano scale pharmaceuticals.  Because our work product is strictly confidential, we fully protect your intellectual property and trade secrets.

Nano in Food and Food Packaging
The FDA also regulates food and food packaging to help ensure food safety.  An increasing number of applications for nanotechnology are being researched to increase shelf life, mimic the taste of ‘fatty’; foods without ingesting the fat, creation and delivery of micro nutrients and others.  nanoTox can provide direction and guidance in these applications and help with Food Contact Notifications (FCN), Food Additive Petitions (FAP) and participate in Generally Regarded As Safe protocols (GRAS).  With our knowledge of nano-particle characteristics, early confidential R&D consulting can help reduce time to market.  Our board certified toxicologists (D.A.B.T. designation) can design and manage all required safety testing under GLP quality standards.

Nano in Cosmetics
The FDA regulates the ingredients of cosmetics, which increasingly contain nanotechnology.  Sun screens, soaps, make-up, lip gloss, and other products include nanotechnology.  nanoTox is a member of the Independent Cosmetic Manufacturers and Distributors (ICMAD) and can provide a variety of R&D consultations, nano-particle characterization and safety testing to ensure that cosmetic products meet FDA regulations.  All work is held in strict confidence to protect intellectual property and trade secrets.
http://www.fda.gov/Cosmetics/default.htm


National Institute of Health (NIH) 
http://www.nih.gov/science/nanotechnology/

NIH major nanotechnology research efforts are focused on cancer therapies and bio-imaging.
National Cancer Institute (NCI)
http://nano.cancer.gov/
http://nano.cancer.gov/action/news/nanotech_news.asp
National Institute of Biomedical Imaging and Bioengineering
http://www.nibib.nih.gov/Research/NIHNano

National Nanotechnology Initiative (NNI)
http://www.nano.gov/
NNI has the responsibility of coordinating the Federal government’s many nanotechnology research programs with the goal of ensuring that the country remains a leader in nanotechnology research and development.

National Institute of Occupational Safety and Health (NIOSH)
http://www.cdc.gov/niosh/

Providing National and World Leadership to Prevent Workplace Illnesses and Injuries
NIOSH has been very proactive in trying to address nanotechnology safety in the workplace.  They have published guidance on this issue which can be found here: http://www.cdc.gov/niosh/topics/nanotech/

Occupational Safety and Health Administration (OSHA)
http://www.osha.gov/
OSHA has responsibility for enforcing legislation and regulations aimed at protecting worker and employee safety and health in the workplace.  Because of their small size (nanometers) and unique physical and chemical properties, nano-particles may present workplace health risks that are as yet unknown.  Safety measures used for normal scale materials may not be adequate in a work environment using nano-particles.  While there are no nanotechnology specific occupational safety regulations, employees are required under the General Duty Clause to provide workplaces free from known hazards.  With nanomaterials being relatively new in the workplace, occupational hazards presented by nanotechnology are unknown.  Nonetheless, employers are potentially at risk for sanctions or fine if they do not implement common sense measures to protect employees from exposures to nano-particles. For a complete discussion of this Clause, please go here:(Paul Sarahan’s article)
nanoTox  has the ability to survey your workplace and make recommendations for reducing or eliminating worker exposures to nano-particles.  This includes manufacturing workplaces as well as corporate and university R&D labs that are researching nanotechnology.

National Institutes of Standards and Technology (NIST)
http://www.nist.gov/index.html

Advancing nanoscale measurement science, standards, and nanotechnology is an important component of NIST's mission to promote U.S. innovation and industrial competitiveness.  http://www.nist.gov/nanotechnology-portal.cfm
Center for Nanoscale Science and Technology (CNST) supports the U.S. nanotechnology enterprise from discovery to production by providing industry, academia, NIST, and other government agencies with access to world-class nanoscale measurement and fabrication methods and technology.  http://www.nist.gov/cnst/index.cfm

Consumer Product Safety Commission (CPSC)
CPSC has not yet issued any regulations specifically addressing the use of nanotechnology in consumer products.  They have issued a CPSC Nanomaterial Statement which can be found here: http://www.cpsc.gov/LIBRARY/CPSCNanoStatement.pdf .
With over 1,000 consumer products containing nanomaterials, and growing at 60% year, CPSC is expected to begin addressing consumer’s concerns about nanotechnology.

California Environmental Protection Agency, Department of Toxic Substance Control (CALEPA, DTSC)
http://www.dtsc.ca.gov/
http://www.dtsc.ca.gov/TechnologyDevelopment/Nanotechnology/nanoport.cfm

California EPA has been very proactive in researching and formulating environmental regulations that address the unique characteristics of nanomaterials.  CALEPA has begun gathering information on carbon nano tubes (CNT) from companies and universities in California (http://www.dtsc.ca.gov/TechnologyDevelopment/Nanotechnology/nanocallin.cfm) and is planning to issue a call-in for nanoscale silver and other nanomaterials of interest (http://www.dtsc.ca.gov/TechnologyDevelopment/Nanotechnology/nanocallin.cfm#Nanometals_and_Nanometal_Oxides_Of_Interest).
nanoTox can help companies comply with the call-in (information request) and reduce your cost and time of preparing a response.

 
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Fact Sheet for Nanotechnology under the Toxic Substances Control Act | Prevention, Pesticides and Toxics (OPPTS) | US EPA
EPA