United States

 

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A consortium of scientists has found that breathing ultrafine particles from a large family of engineered nanomaterials (ENMs) that increasingly are found in a host of household and commercial products can cause lung inflammation and damage. The researchers examined responses of the lungs to nanomaterials made from three forms of titanium dioxide and three forms of multi-walled carbon nanotubes in a mouse model. The primary concern for exposure to most ENMs is by inhalation, although dermal, eye and ingestion exposures also may occur during the manufacture and commercial application of these materials in a wide variety of products.

The research on two of the most common types of ENMs already in widespread use was published online May 6, 2013, in Environmental Health Perspectives, the journal of the National Institute of Environmental Health Sciences (NIEHS). It is the first multi-institutional study examining the health effects of engineering nanomaterials to replicate and compare findings from different labs across the country.

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The U.S. Food and Drug Administration in April 2012 issued two draft guidance documents relating to the use of nanotechnology in food and food packaging and cosmetics.

"[Draft] 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," covers the use of nanotechnology in the manufacture of food ingredients, including color additives, and food contact substances, e.g., packaging.

“[Draft] Guidance for Industry: Safety of Nanomaterials in Cosmetic Products,” covers the use of nanotechnology in cosmetics.

These draft guidance documents are the subject of a summary article by attorney Lynn Tyler (Barnes & Thornburg LLP), published in Product Liability Law360, on May 29, 2012, "Tightening FDA Nanotech Regs on Food, Cosmetics."

According to Tyler: "The message of the two guidance documents is similar: Manufacturers in these industries who incorporate nanoscale ingredients into their products should be prepared to prove that the resulting products are safe and that appropriate tests were used to validate their safety."

Excerpts of the article are provided below.

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The first lawsuit over regulation of the health and environmental risks of nanotechnology and nanomaterials has been voluntariliy dismissed.  That suit was the subject of my post, First Lawsuit on Risks of Nanotechnology in Consumer Products is Filed.

The Lawsuit's Origin

On December 21, 2011, a coalition of nonprofit consumer safety and environmental groups sued the Food and Drug Administration (FDA) in the United States District Court for the Northern District of California. International Center for Technology Assessment, et al v Margaret A. Hamburg, M.D., Case No. CV 11-6592, is an Administrative Procedure Act case seeking declaratory and injunctive relief. The Plaintiffs (ICTA; Friends of the Earth; The Action Group on Erosion, Technology and Concentration; The Center for Environmental Health; Food and Water Watch; and the Institute for Agriculture and Trade Policy) demand that the FDA respond to a petition these organizations filed with the agency in 2006.

The Lawsuit's Conclusion

The Plaintiff groups agreed to drop the lawsuit because the FDA has now formally responded to their petition, though the agency rejected some of their key proposals.  The groups had also requested that the agency subject its nanotechnology program to a comprehensive environmental review under the National Environmental Policy Act.

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As discussed in a previous post, on December 28, 2011, the United States Environmental Protection Agency (EPA) proposed significant new use rules (SNURs) for 17 chemicals, more than a dozen of which were carbon nanotubes and fullerenes.

These new chemicals have already been allowed to go into production, but with protective measures outlined in consent orders or premanufacture notices filed by specific companies. The proposed rules adopt those conditions so they would apply to other manufacturers who want to make the substances.

The SNURs would require manufacturers to notify the EPA 90 days prior to beginning production of the intended new use, in order to give the agency time to determine if the way the manufacturers wanted to make or use the chemicals poses an unreasonable risk to people or the environment.

The new rules identify the concerns the EPA has with each of the chemicals, and the specific worker protection or protective actions required, if any. The absence of such protective measures, under the SNURs, would result in a significant new use designation.

Parties originally had until January 27, 2012, to submit comments on the proposed rules.  But the EPA has indicated that it will extend the comment period, probably to March 2012, following concerns voiced by unions and other groups.

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The federal government needs a better plan and additional funding to assess the environmental and health risks posed by nanomaterials, a National Research Council panel said in a report released on January 25, 2012.

The report, "A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials", was authored by the ad hoc NRC Committee to Develop a Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials.

The report of the 19-scientist Committee presents a strategic approach for developing research and a scientific infrastructure needed to address potential health and environmental risks of nanomaterials. Its effective implementation would require sufficient management and budgetary authority to direct research across federal agencies – which does not currently exist.

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The Natural Resources Defense Council (NRDC) filed a federal suit against the U.S. Environmental Protection Agency on January 26, 2012, seeking to overturn EPA's decision to conditionally approve nanosilver under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). It marks the first time ever that EPA's approval of a nanoscale chemical has been challenged in court. The NRDC petition was filed with the 9th U.S. Circuit Court of Appeals, headquartered in San Francisco, Calif.

The NRDC petition claims that sales of the nanosilver-based pesticide should be halted because the health risks of the substance are unknown. The environmental advocacy group, which has been highlighting potential safety concerns about the use of ultra-tiny silver particles as an antimicrobial agent for several years, accused the EPA of giving the manufacturer a “four-year free pass” by allowing the pesticide to come to market before health and safety testing has been completed.

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On 12/20/11, the National Institute of Standards and Technology issued the world's first standard reference material for single-wall carbon nanotubes. 

NIST also issued a proposed material safety data sheet for single-wall carbon nanotubes.

Carbon nanotubes are the most commonly used nanomaterial in industrial applications and both the reference material and MSDS are important to companies that make or use single-wall carbon nanotubes. Having NIST's reference materials provides an important starting point for companies developing their own SWCNTs or developing applications for existing SWCNTs.

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On December 28, 2011, the United States Environmental Protection Agency (EPA) proposed significant new use rules (SNURs) for 17 chemicals, more than a dozen of which were carbon nanotubes and fullerenes.

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The legal battle has finally been joined.  The first lawsuit over the health and environmental risks of nanotechnology and nanomaterials has been filed.

On December 21, 2011, a coalition of nonprofit consumer safety and environmental groups sued the Food and Drug Administration (FDA) in the United States District Court for the Northern District of California. International Center for Technology Assessment, et al v Margaret A. Hamburg, M.D., Case No. CV 11-6592, is an Administrative Procedure Act case seeking declaratory and injunctive relief. The Plaintiffs (ICTA; Friends of the Earth; The Action Group on Erosion, Technology and Concentration; The Center for Environmental Health; Food and Water Watch; and the Institute for Agriculture and Trade Policy) demand that the FDA respond to a petition these organizations filed with the agency in 2006.

The eighty-page 2006 Petition documents the groups' claimed scientific evidence of nanomaterial risks stemming from their unpredictable toxicity and seemingly unlimited mobility. The 2006 petition requested FDA take several regulatory actions, including requiring nano-specific product labeling and health and safety testing, and undertaking an analysis of the environmental and health impacts of nanomaterials in products approved by the agency. The FDA had yet to act on the 2006 petition, prompting the suit.

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The National Nanotechnology Initiative (NNI)'s latest environmental, health, and safety research strategy, published in October 2011, highlights what has become a risk assessment focus within the world of nano safety: The need to look at the entire impact of an application or product, from the workers who manufacture it to how the consumer uses it to the way it’s disposed of.

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The United States National Nanotechnology Initiative (NNI) this week released its 2011 NNI Environmental, Health and Safety (EHS) Research Strategy, which provides an integrated research framework meant to guide all federal agencies participating in NNI.

Six core categories of research were identified:

1. Nanomaterial Measurement Infrastructure
2. Human Exposure Assessment
3. Human Health
4. Environment
5. Risk Assessment and Risk Management
6. Informatics and Modeling.

The strategy also aims to address the various ethical, legal, and societal implications of this emerging technology.

The strategy is grounded in the principles of risk assessment and product life cycle analysis, so as to measure risk at every stage of a product’s development, from preliminary handling of raw materials to final disposal of finished products.

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The U.S. Environmental Protection Agency announced on June 9, 2011, that it plans to obtain information on nanoscale materials in pesticide products.

Pesticidal Applications of Nanotechnology:  The use of nanoscale materials in pesticide products and treated articles may allow for more effective targeting of pests, use of smaller quantities of a pesticide, and minimizing the frequency of spray-applied surface disinfection. These could contribute to improved human and environmental safety and could lower pest control costs. For example, as a materials preservative, nanosilver should maintain its ability to reduce the number of odor causing bacteria longer and require smaller quantities than other silver preservatives due to an expected gradual and controlled release of silver ions from nanosilver as opposed to the rapid release of for example, silver ions from a zeolite structure or the immediate dissolution of a silver salt. 

Regulation of Nanotechnology in Pesticides:  FIFRA and EPA’s implementing regulations provide an effective framework for regulating pesticide products that contain a nanoscale material. Currently, the Office of Pesticide Programs (OPP) describes a nanoscale material as an active or inert ingredient of a pesticide and any component parts thereof intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers.

The OPP recognizes that special properties that make nanoscale materials of potentially great benefit also can present new challenges for risk assessment and decision-making.  For instance, their small size may allow them to pass through cell membranes or the blood-brain barrier, possibly resulting in unintended effects.  The EPA recognizes that government, academic, and private sector scientists in multiple countries are performing research into the human health effects of diverse nanoscale materials, resulting in a substantial and rapidly growing body of scientific evidence.

New Policy for Nanotechnology in Pesticides:

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On June 9, 2011, the U.S. Food and Drug Administration announced a draft Guidance for Industry about the use of nanotechnology by industries the agency regulates, calling it the “first step” in determining whether products contain the emerging technology.

The draft guidance, "Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology," is available online and open for public comment. It represents the first step toward providing regulatory clarity on the FDA's approach to nanotechnology.

FDA is releasing its document in coordination with the "Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials" issued on June 9, 2011, jointly by the Office of Science and Technology Policy, Office of Management and Budget, and the United States Trade Representative.

The guidance is intended for manufacturers, suppliers, importers and other stakeholders. The guidance describes FDA’s current thinking on whether FDA-regulated products contain nanomaterials or otherwise involve the application of nanotechnology.

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In a set of recommendations that could have far-reaching implications, the National Institute for Occupational Safety and Health has concluded that airborne super-small particles of titanium dioxide “should be considered a potential occupational carcinogen.”

A recently released NIOSH guidance document (NIOSH, 2011) on handling titanium dioxide (TiO2) powders in the workplace has generated a high level of interest as it puts forward an innovative approach that might have implications beyond TiO2.

The new document outlines the agency’s suggestions for exposure levels that will avoid long-term problems. The bulletin is discussed in some detail at the CDC/NIOSH Science Blog.

 

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Two Sections of the American Bar Association are presenting a half-day program that may be of interest to you. “Nano Governance: The Current State of Federal, State, and International Regulation,” is being presented as a webinar and for attendance at several host sites on Thursday, May 19, 2011, at 1:00 p.m. – 5:30 p.m. Eastern Time.

A number of knowledgeable experts have been lined up to speak by the co-sponsoring Section of Science and Technology Law: Nanotechnology Committee (of which this blogger is a member) , and Section of Environment, Energy, and Resources: Pesticides, Chemical Regulation and Right-to-Know Committee.

The program brochure is available here.   A program overview and educational objectives are shown below.

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"Potential Human Health Risks of Nanomaterials" was published in the March issue of the International Risk Management Institute (IRMI) newsletter.

The article, authored by Gradient Corp.’s Dr. Marc Nascarella and Dr. Barbara Beck, along with Attorney Joseph Clark of Day Pitney LLP, focuses on the potential human health hazards, risks, and liability issues associated with nanomaterial exposure.

The full article is available here, and is excerpted below.

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A joint workshop between the United States and the European Union will be held from March 10-11, 2011 in Washington, DC, in an effort to promote more effective collaboration between the two entities.

The purpose of the workshop, "The US and EU: Bridging NanoEHS Research Efforts", is to: Engage in an active discussion about Environmental Health and Safety questions for nano-enabled products; Encourage joint programs of work that would leverage resources; and, Establish communities of practice, 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.

Sponsors include the U.S. National Nanotechnology Initiative (NNI), the European Commission, the American Association for the Advancement of Science, and the U.S. Environmental Protection Agency.

The full program can be viewed online at the link below.
http://www.nano.gov/html/meetings/us-eu/index.html

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One of the most exciting new developments in pesticides is the prospect of nanopesticides. Nanotechnology is being used to develop pesticides with new or enhanced activity, or more targeted application (such as through microencapsulation or affinity for specific target pests).

Pesticides are regulated under several laws, primarily the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) which authorizes EPA to oversee the registration, distribution, sale, and use of pesticides. The Act applies to all types of pesticides, including insecticides, herbicides, fungicides, rodenticides, and antimicrobials. The EPA’s Office of Pesticide Programs has already formed a Nanotechnology Work Group to develop a regulatory framework for nanopesticides. Two recent OPP presentations are instructive.

“Nanotechnology and Pesticides” presentation was made in April 2010, at the EPA Pesticide Program Dialogue Committee (PPDC) meeting.  The April 2010 OPP presentation included the following:

“Why is OPP Concerned?

Potential Human Health Concerns:
- Dermal absorption (so small they may pass through cell membranes)
- Inhalation (go to the deep lung and may translocateto the brain i.e, could cross the blood brain barrier)

Potential Environmental Concerns:
- High durability or reactivity of some nanomaterials raises issues on the fate in environment
- Lack of information to assess environmental exposure to engineered nanomaterials.”

For a good summary of the nanotechnology pesticide issues discussed at the PPDC meeting, see http://nanotech.lawbc.com/2010/05/articles/united-states/federal/ppdc-discusses-nanotechnology-and-pesticides/

“EPA Regulation of Pesticides Containing Nanoscale Materials” presentation was made in September 2010, at the meeting of the State Federal Insecticide, Fungicide, and Rodenticide Act Research and Evaluation Group (SFIREG) Pesticide Operations and Management (POM) Committee.  The September 2010 OPP presentation included an indication that EPA intends to require that nanoproducts be labeled in some fashion under FIFRA.

The EPA is of course not the only organization working on this issue. In a study published on October 4, 2010, in the International Journal of Occupational and Environmental Health, scientists from Oregon State University and the European Union outline six regulatory and educational issues that should be considered whenever nanoparticles are going to be used in pesticides.

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The EPA on September 17, 2010, published final Significant New Use Rules (SNURs) for both single-walled and multi-walled carbon nanotubes. Those types of carbon nanotubes are the most commonly used nanomaterial in industrial applications and are gaining increasingly widespread use in a variety of consumer products.

Many nanoscale materials – including nanotubes – are regarded as "chemical substances" under the Toxic Substances Control Act (TSCA). To ensure that nanoscale materials are manufactured and used in a manner that protects against unreasonable risks to human health and the environment, EPA is pursuing a comprehensive regulatory approach under TSCA. This four-pronged approach includes: Premanufacture notifications; Significant New Use Rules; an information gathering rule; and a test rule.

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Nanotechnology VI Symposium: “Progress in Protection” is co-sponsored by the California Department of Toxic Substances Control (DTSC) and the University of California Los Angeles’ Center for the Environmental Implications of Nanotechnology (UC-CEIN). The symposium will build on topics discussed at DTSC’s previous nanotechnology symposiums. It also emphasizes occupational safety and health concepts, which are keys to reducing potential risks to workers and the environment from engineered nanomaterials (ENMs).

Discussion topics will include:  

- Collaboration between DTSC’s Office of the Chief Scientist, the National Institute for Occupational Safety and Health (NIOSH) and California’s leading universities to fill data gaps via the development of ENM risk-based guidelines. 

-Practical insights from current nanomaterial manufacturers regarding health and safety.

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The FDA Center for Devices and Radiological Health (CDRH) is organizing a public workshop titled "Medical Devices and Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations" to be held on September 23, 2010, in Gaithersburg, MD.

There is no registration fee for the public workshop. All parties who are interested in the application of nanotechnology in medical devices are encouraged to register and actively participate in this workshop. Registration and detailed event information relating to this day-long workshop can be found at the following location: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm222591.htm

The FDA’s stated purpose of this workshop is “to obtain information on the safety and effectiveness of medical devices utilizing nanotechnology.” More specifically, FDA “would like public input on manufacturing, characterization, and biocompatibility evaluation of medical devices containing or utilizing nanomaterials and nanostructures, including diagnostics. FDA is seeking input on these topics and requests comments on a number of related questions.”

There are two planned sessions for the workshop:

Session I: Manufacturing/characterization of medical devices containing or utilizing nanomaterials or nanostructures
Session II: Biocompatibility/biodistribution/toxicity evaluation for medical devices containing or utilizing nanomaterials or nanostructures

Each session provides three types of participation – expert presentations, an industry/public comments period, and then a round-table discussion. The FDA will select participants for roundtable discussions based on their relevant experience with nanotechnology, and will attempt to have a range of constituencies represented.

For anyone following nanomedicine and related risks and regulatory issues, in particular for devices and products that fall under the auspices of the CDRH, this promises to be an informative event.

Source: FDA

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The Massachusetts Office of Technical Assistance & Technology (OTA) recently prepared a Technology Guidance Document, “Nanotechnology – Considerations for Safe Development”

The OTA is a department of the state’s Executive Office of Energy and Environmental Affairs, and is responsible for helping entities in the state achieve superior environmental, health and safety performance while also improving economic sustainability.

According to the Guidance, “there are indications of potential harm from certain exposures and releases of engineered nanoparticles (ENPs), and it is essential to recognize, reduce and control these risks when they are present.” The Guidance was prepared for “the express purpose of assisting in the development of this technology, as failure to prevent exposures or releases will not just risk harm to health or the environment—it will also impede the common interest in realizing the benefits that nanotechnology can provide.”

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"EPA May Give 1st Approval of Nanosilver for Fabrics"  is the latest installment in the ongoing AOL News Special Report series about nanotechnology risk.  The story addresses news that the EPA may soon issue "conditional approval" to Swiss chemical company HeiQ Materials AG, a producer of nanosized additives, for the use of a nanosilver pesticide as a new active ingredient in fabrics.

The public has been given 45 days (until September 11, 2010) to comment on the EPA's proposal.

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The call for a greater sense of urgency by government was reiterated again on June 25, 2010. A new report issued that date by the United States Government Accountability Office (GAO), "Nanotechnology: Nanomaterials Are Widely Used in Commerce, but EPA Faces Challenges in Regulating Risk," says that the U.S. Environmental Protection Agency (EPA) needs to expand its efforts to obtain health, environmental, and safety information about nanomaterials and effectively regulate them. The GAO report was requested by the Senate Committee on Environment and Public Works.
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The National Institute for Occupational Safety and Health (NIOSH) and the Mountain and Plains Education and Research Center will hold a conference on "Nanomaterials and Worker Health: Medical Surveillance, Exposure Registries, and Epidemiologic Research."

The conference will be held on July 21–23, 2010, at the Keystone Resort and Conference Center in Keystone, Colorado.

NIOSH, part of CDC, is the federal agency legislatively established under the Occupational Safety and Health Act of 1970 that conducts research to prevent work-related injury, illness, and death.  NIOSH has been perhaps more active than any other U.S. federal agency so far in nanoparticle EHS research and I discuss the body of information available from NIOSH concerning whether nanomaterials pose risks for occupational illness at my earlier post, NIOSH Nanotechnology Health & Safety Update: Updated, Enhanced Web Resources Posted 12/8/09.

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. . . then you simply must start becoming knowledgeable, if not expert, on the uses of nanotechnology in agriculture and food production, food products, food processing, and food packaging. It is going to be a significant growth area and an expected litigation field within the food safety/toxic exposure arena.

I'd suggest you might do a couple things to get started:

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“A mounting body of research shows nanoparticles can cause disease and death. But regulators are doing little to respond.”

Strong words.  They are the opening sentence in Part 1 of a recent Special Report series of articles by Andrew Schneider, an investigative reporter, two-time Pulitzer winner, and Senior Public Health Correspondent for AOL News.  In his series, "The Nanotech Gamble: Bold Science, Big Money, Growing Risks,” which ran in AOL News beginning March 24, 2010, Schneider is harshly critical of federal government’s nanotech safety research efforts so far, asserting that federal funding actually “skimps on safety.”

The AOL Special Report series is a "must read" for anyone keeping abreast of the ongoing debate and discussion of nanotechnology safety. 

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The President's Council of Advisors on Science and Technology (PCAST) last week approved a report that urges "federal agencies to increase their collaboration on environmental, health, and safety questions arising from various applications of nanotechnologies."
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The Obama Administration’s just-released National Nanotechnology Initiative’s (NNI) Supplement to the President’s 2011 budget indicates that the United States is doing some catch-up with Europe in addressing the safe development and use of nanotechnology-enabled materials, products and processes.

The best discussion and commentary I have seen on the issue is from Andrew Maynard in his blog 2020 Science. Here is some of what Maynard views as noteworthy:

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Scientists from the FDA and the National Cancer Institute have found that nanoscale titanium dioxide used in sunscreen is unlikely to penetrate healthy human skin. The study, "Lack of Significant Dermal Penetration of Titanium Dioxide (TiO2) from Sunscreen Formulations Containing Nano- and Sub-micron-sized TiO2 Particles," published February 15, 2010, in Toxicological Sciences, addresses concerns that the commonly used sunscreen nanoscale ingredient could cause harm to people if capable of entering the bloodstream through dermal absorption. read more

On February 3, 2010, the United States Environmental Protection Agency (EPA) proposed a significant new use rule (SNUR) for certain multi-walled carbon nanotubes (MWCTs) for which it has already received a premanufacture notice.  Manufacturers and importers of MWCTs would now have to notify the EPA if they plan to use the substance differently than outlined in their premanufacture submission.

The new proposed rule indicates the EPA’s belief that different uses than those described in the premanufacture notice could result in increased exposures, thereby constituting a new use. The EPA would want to assess and potentially regulate any such new use, prior to the proposed use occurring.

According to an article in today’s BNA Daily Environment Report, the EPA "has decided that use of the nanotubes without gloves and protective clothing, thereby creating the potential for exposure through the skin or by inhalation, may cause serious health effects. Serious health effects also could occur if the nanotubes are used without a National Institute for Occupational Safety and Health-approved full-face respirator with an N100 cartridge or if it is used in ways other than as described in the premanufacture notice."

The EPA is accepting comments on the proposed rule through March 5, 2010.

Sources: The Bureau of National Affairs' Daily Environment Report; Meridian Nanotechnology and Development News

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On January 21, 2010, U.S. Senators Mark Pryor (D-AR) and Benjamin L. Cardin (D-MD) introduced The Nanotechnology Safety Act of 2010. The legislation aims to address potential health and safety risks about products that contain nanotechnology materials by establishing a program within the FDA to assess the health and safety implications of nanotechnology in everyday products. read more

The editors of Scientific American write that the United States Environmental Protection Agency (EPA) must act swiftly to evaluate the possible health risks of nanotechnology.

Nanotechnology, they say, could emerge as an important tool to fight the threats of global warming and disease, but nanomaterials carry with them the potential for both good and harm.

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The United States Environmental Protection Agency’s (EPA) Regulatory Plan and Semiannual Regulatory Agenda, released on December 7, includes two potential new regulations aimed at gathering data on nanoscale chemicals:

-  New Reporting Requirement to Facilitate TSCA Application to Nanomaterials 

-  New Testing of Some Widely Used Nanomaterials

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On December 8, 2009, the National Institute for Occupational Safety and Health (NIOSH) has updated and enhanced several web resources containing NIOSH’s research results and recommendations on the work-related health and safety implications of nanotechnology.

The updated resources describe the latest scientific information available from NIOSH in its studies to help determine whether nanomaterials pose risks for occupational illness or injury. The enhancements are intended to help partners and stakeholders find information more easily and quickly.

“The body of scientific information on the health and safety implications of nanotechnology has grown substantially in the past five years, and continues to do so,” said NIOSH Director John Howard, M.D. “We are pleased to reflect this ongoing evolution of the science by regularly updating and augmenting the widely used and widely cited resources on our web page.”

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On November 19, 2009, the United States National Institute of Environmental Health Sciences (NIEHS), part of the National Institutes of Health, announced that it is increasing its investment in understanding the potential health, safety and environmental issues of the nanoparticles used in everyday products.   The NIEHS press release can be viewed online at this link: http://www.niehs.nih.gov/news/releases/2009/nanotech.cfm
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A speaker at the workshop "Nanomaterials and Human Health & Instrumentation, Metrology, and Analytical Methods," being held this week as part of the White House's National Science and Technology Council, said, in a talk he meant to be provocative, that researchers can use cellular tests to obtain any result they want concerning the toxicity of a nanomaterial. read more

 A symposium, “Approaches to Safe Nanotechnology: A Global Perspective,” was held at the XVIII World Congress on Safety and Health at Work in Seoul, Korea.  That brought together speakers/scientists from seven countries to discuss the topic, including those from the United States, Japan, Korea, Australia, Germany, France, and Italy.  The lessons learned and the importance of global collaboration on nanotechnology safety and health research were discussed.  A report of the symposium proceedings was recently published by the United States participant, the National Institute for Occupational Safety and Health (NIOSH), “A Global Perspective on Safe Nanotechnology,” NIOSH Publication No. 2009-130. read more

An article by Reed D. Rubinstein of Greenberg Traurig LLP, in the new issue of Nanotechnology Law & Business (Fall 2009), discusses a “petition” filed with the United States Environmental Protection Agency (EPA) by the International Center for Technology Assessment (ICTA) and other special interest groups. The Petition claims that “research has mounted to indicate that nano-silver materials pose serious risks to human health and the environment.” As a result, the Petition demands (among other things) that the EPA regulate all nano-silver products as pesticides, and stop the use or sale of all consumer products using nano-silver under the authority of FIFRA, the Federal Insecticide, Fungicide and Rodenticide Act. read more

Concerns have been raised about whether workers exposed to engineered nanoparticles are at increased risk of adverse health effects. The current body of evidence about the possible health risks of occupational exposures to engineered nanoparticles is quite small, and uncertainty means risk.

A new Canadian study to appear in a forthcoming issue of the International Journal of Nanotechnology suggests that current protective equipment used for existing chemicals may not offer adequate protection for workers handling nanomaterials. The study, by engineers in the Department of Mechanical Engineering at Montreal’s School of Higher Technology, suggests that urgent research is necessary into the risks associated with the growing field of nanotechnology manufacture so that appropriate protective equipment can be developed. Prevention of harmful exposures from ingestion, inhalation, and dermal absorption are the reason that protective clothing and gloves, in addition to respirators, are often an essential and common sight in the chemical industry. However, the Canadian researchers wonder if standard protection against chemical risks is enough for workers who are handling nanomaterials. read more

The FDA has thus far been relatively unconcerned about any unique safety issues of nanoscale products under its auspices, and believes that existing standards for safety and efficacy will be adequate for most nanotechnology medical products.  The FDA’s Nanotechnology Task Force published its Report in July 2007 and did not suggest the need for any immediate nano-specific regulatory action, but did recognize that obvious knowledge gaps exist concerning new risks presented by nanomaterials.  The FDA's position has critics. 

It remains to be seen what additional internal processes or regulatory actions, if any, the FDA will pursue to address nanospecific product and safety issues. This is an evolving area of regulatory law and all pharmaceutical, medical device, and health care risk managers and their attorneys must stay closely attuned.

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The mission of the U.S. Food and Drug Administration is, in part, to ensure that the drugs, drug delivery systems, medical devices, vaccines, and other biologic products reaching the marketplace are safe and effective. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicine more effective and more affordable. The oncoming "Age of Nanotechnology" brings into sharp focus the tension between assuring that regulated products are safe and effective while at the same time ensuring that new and potentially life-saving treatments are made available to the public as quickly as possible.

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Regulation and Standards Development is Active . . .

- Government
- Quasi-Government
- Industry/Private Sector

. . . but still in early stages. No current health or environmental regulatory program squarely addresses nanotechnology or its applications.   EPA, FDA, OSHA, CPSC and USDA all claim statutes and regulations that could pertain to nanomaterials, as do federal research agencies such as CDC-NIOSH, NIH, and NIEHS (all agencies of the Dept. of HHS).  Each is currently evaluating to address novel risks of nanotechnologies and nanoparticlesgermane to their respective regulatory missions, and several now have stand-alone nanotechnology-focused working groups and have published initial reports of interest.  For example:

Environmental Protection Agency (EPA)

-   EPA, Nanotechnology White Paper (2007) http://epa.gov/ncer/nano/publications/whitepaper12022005.pdf 

For current information see the EPA's nanotechnology web page.

Food and Drug Administration (FDA)

 -  FDA, Nanotechnology Task Force Report (2007)http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/NanotechnologyTaskForceReport2007/default.htm

For current information see the FDA's nanotechnology web page.

Centers for Disease Control and Prevention / National Institute for Occupation al Safety and Health (CDC-NIOSH)

-  CDC-NIOSH, Progress Toward Safe Nanotechnology in the Workplace (2007) http://www.cdc.gov/niosh/docs/2007-123/pdfs/2007-123.pdf

For current information see the CDC-NIOSH nanotechnology web page.

Consumer Product Safety Commission (CPSC)

    Although the CPSC has no similar agency-level nanotechnology report, a good discussion of relevant consumer product nanotechnology issues was published by the Project on Emerging Nanotechnologies:

-  The CPSC and Nanotechnology (2008)
http://www.nanotechproject.org/process/assets/files/7033/pen14.pdf

 The CPSC recognizes that nanotechnology will be a continuously increasing concern, and nanotechnology was a focal point of the CPSC's August 25, 2009, hearing on its 2010-2011 agenda, priorities, and strategic plan.  Panelists at the hearing urged the CPSC to increase oversight of products manufactured with nanomaterials and to establish relevant safety guidelines for their use.    To read the panelists full testimony, see the CPSC web page.

 

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The Age of Nanotechnology is here. Welcome to the Nanotort Law Blog.  

The Nanotort Law Blog aims to be a useful resource for lawyers and risk managers. It will help you stay abreast of the current state of hazard assessment knowledge, pertinent governmental regulation, industry and NGO standards and guidelines, and other important information germane to environmental, health, and safety risks and potential liabilities. The Nanotort Law Blog will also offer ideas and links to other helpful resources to help you monitor, understand and manage the potential - and as yet unkown - liability risks of Nanotechnologies.

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