Government Activity/Initiatives

 

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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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German officials are leading a push for a major revision of the European Union's REACH regulation as it deals with nanomaterials due to continued concerns over their potential hazard to humans and the environment.

The EU Commission's Second Regulatory Review on Nanomaterials, published in October 2012, said nanosubstances do not require a special regulatory framework and their risks can largely be addressed through REACH.   But REACH does not set out any specific requirements for nanosubstances.

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The U.S. Food and Drug Administration in April 2012 issued two draft guidance documents relating to the use of nanotechnology in food and food packaging and cosmetics.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These draft guidance documents are the subject of a summary article by attorney Lynn Tyler (Barnes & Thornburg LLP), published in Product Liability Law360, on May 29, 2012,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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REACH, the European Union's primary regulation on chemicals is failing to identify or control nanomaterials. That is the conclusion of "Just Out of REACH: How REACH is failing to regulate nanomaterials and how it can be fixed," a report published February 6, 2012, by the nonprofit Center for International Environmental Law (CIEL).

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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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A project funded by the Danish Environmental Protection Agency (EPA), has resulted in the development of a new nanomaterial risk assessment tool called NanoRiskCat (NRC). The project's aim was to identify, categorize, and rank exposures and effects of nanomaterials used in consumer and industrial products based on data available in the peer-reviewed scientific literature and other regulatory relevant sources of information and data. The primary focus was on nanomaterials relevant for professional end-users and consumers, as well as nanomaterials released into the environment. The tool is a valuable step but needs to be further validated and tested on a series of various nano products in order to adjust and optimize the concept.

The project report, NanoRiskCat - A Conceptual Decision Support Tool for Nanomaterials, is 268-pages long.  I've provided what I hope is a succinct, but still sufficiently robust, summary of the NRC project and report below, from the report's Executive Summary. 

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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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On November 24, 2011, the EU's SAFENANO and ObservatoryNANO published an excellent new resource, the “Nanotechnology EHS Landscape” report.   I recommend a review by anyone with an interest in nanosafety and risk issues.

SAFENANO continues to offer great up-to-date information on nano safety issues and is one of my "must-read" sites on a regular basis.

The new report provides a map and concise overview of key organizations and their activities in nanotechnology Environment, Health and Safety (EHS) issues.  Activity in this sector has been growing for a decade, with multiple position papers, roadmaps, standardization committees, research groups, and significant research conducted. The literature has grown exponentially in the past 3 years in particular.

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SAFENANO, Europe's Centre of Excellence on Nanotechnology Hazard and Risk, along with the Institute of Occupational Medicine (IOM), have announced the official launch of the European Research project MARINA (MAnaging RIsks of NAnoparticles).

While there are standard procedures for product life cycle analysis, exposure, hazard, and risk assessment for traditional chemicals, it is not yet clear how these procedures need to be modified to address all the novel properties of nanomaterials. There is still an acute need to develop specific reference methods for all the main steps in managing the potential risk of ENM. The aim of MARINA is to develop such methods.

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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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A recent document from the Organization for Economic Co-operation and Development (OECD), “Current Developments/Activities on the Safety of Manufactured Nanomaterials,” provides an update on current developments and activities regarding the safety of manufactured nanomaterials in OECD member countries, and other delegations that attended the 8th meeting of the OECD’s Working Party on Manufactured Nanomaterials, held in Paris, France from March 16 to 18, 2011. 

 

The document includes written reports on current activities related to nanotechnologies and nanomaterials in other international organizations, such as the International Organization for Standardization, the Food and Agriculture Organization of the United Nations, and the World Health Organization.  This resource is intended to provide delegations and other stakeholders with a “snapshot” (current to March 2011) of information on activities related to manufactured nanomaterials, as well as other nanotechnology activities, at the national and international level.

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On May 10, 2011, the European Food Safety Authority (EFSA) published a guidance document for the risk assessment of engineered nanomaterial (ENM) applications in food and feed  in response to a request from the European Commission,

 

“Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain” is the work of the EFSA’s Scientific Committee and is the first of its kind to give practical guidance for addressing potential risks arising from applications of nanoscience and nanotechnologies in the food and feed chain. The guidance covers risk assessments for food and feed applications including food additives, enzymes, flavorings, food contact materials, novel foods, feed additives and pesticides.

 

The EFSA guidance sets out the considerations for risk assessment of ENM that may arise from their specific characteristics and properties.

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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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SAFETY ISSUES OF NANOMATERIALS ALONG THEIR LIFE CYCLE is a two day Symposium that will be held on May 4-5, 2011, at LEITAT Technological Center, Barcelona (Spain).  It is jointly organized by the coordinators of three European Community nanotechnology safety research projects: NANOPOLYTOX, NEPHH and HINAMOX.  

The aim of the Symposium is to discuss the human and environmental impacts of nanomaterials along their life cycle from their production through their processing, use, and end of life (recycling and/or disposal).   Therefore, the tools and methodologies proposed for the risk assessment (RA) and Life Cycle Assessment (LCA) of nanomaterials will be one of the main topics of discussion in this symposium.

A panel of international experts have been invited as speakers and the lectures will be organized into six different sessions:

Session 1. International, national and regional initiatives on Nanotechnology / Nanosafety
Session 2. Nanomaterials: Synthesis, characterization and applications
Session 3. Human health impact of Nanomaterials
Session 4. Environmental impact of Nanomaterials
Session 5. Risk assessment of Nanomaterials
Session 6. Life cycle assessment of Nanomaterials

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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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An October 25, 2010, joint press release from Europe’s two largest consumers umbrella groups, BEUC and ANEC, is entitled “ANEC/BEUC inventory exposes a game of roulette.”

"Nano whitening"

"Using the newest Nanotechnological ingredients"

"Uses the Nano Silver technology which protects the baby's skin"

Consumer products containing a number of nanomaterials are already widely available on the European market and these are just some of the come-ons used in stores or online.

In 2009 the European Consumers' Organization (BEUC) and its sister organization, ANEC, started to monitor the availability of consumer products containing nanomaterials. The initial 2009 inventory listed 151 products, while in 2010 the number rose to 475. The BEUC inventory has product categories representing those most often consumed in everyday life such as child products, food & drink, cosmetics, products for cars and electronic devices.

The inventory and explanatory leaflet can be found on the BEUC website.

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The accelerating trend of nanomaterial government regulation continues, this time in Australia.   These are significant because Australia is the world's 13th largest economy and a major export destination for the products of United States manufacturing companies.  

 

The new regulatory processes, enacted under the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), will take effect on January 1, 2011, and will apply to any new material/chemical that falls under the following working definition of an "industrial nanomaterial":

 

...industrial materials intentionally produced, manufactured or engineered to have unique properties or specific composition at the nanoscale, that is a size range typically between 1 nm and 100 nm, and is either a nano-object (i.e. that is confined in one, two, or three dimensions at the nanoscale) or is nanostructured (i.e. having an internal or surface structure at the nanoscale)"

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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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In late September 2010, The Centre for Food Safety (CFS), an arm of the Government of the Hong Kong Special Administrative Region of the People’s Republic of China, published a risk assessment study “Nanotechnology and Food Safety.”

The aims of the study were:

- to identify applications of nanotechnology in the food sector
- to identify the potential health and safety implications of nanotechnology in the food sector; and
- to review existing strategies for the risk assessment of engineered nanomaterials in food.

Some key excerpts from the CFS Study are included below.

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The European Food Safety Authority (EFSA) and Belgian Federal Agency for the Safety of the Food Chain are hosting an International Symposium on Nanotechnology in the Food Chain, to be held in Brussels, Belgium on November 24, 2010.

Nanotechnology has many promising applications emerging for the areas of agriculture and food (smart packaging, agrochemicals, etc.). It has the potential to bring significant benefits to the agriculture and food industries and to consumers, but may also introduce potential risks for human health and the environment.

The Symposium will present the current knowledge regarding the applications, opportunities and risks of nanotechnology in the food chain.  It will also consider the gaps in knowledge, legislation and control methods, in order to inform an international audience of policy makers, consumers, researchers, industrial representatives, etc.

Complete information on the Symposium and the program may be found on this site:
http://www.favv-afsca.fgov.be/nanotechnology/information/

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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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Ahead of the EU Commission’s nanotechnology regulatory review next year, several EU members are advocating the creation of a specific register for nanomaterials under the EU’s REACH (Registration, Evaluation, and Authorization of Chemicals) chemicals regulation. There are also calls for mandatory labeling of the presence of nanomaterials in consumer products sold in the EU.

Most recently, on September 14, 2010, the Belgian EU Presidency proposed those nanotechnology regulatory measures at the opening of an EU workshop on the traceability of nanomaterials. "Nanomaterials are increasingly present in consumer products and everyday items we use, and yet we don't know a lot about them," said Paul Magnette, the Belgian minister in charge of consumer protection and environment. He also argued that "the current development approach for nanomaterials without prior notification of their presence or labelling of their characteristics or potential toxicity is not acceptable".

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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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In Germany the early detection of health risks in consumer-related areas is the responsibility of the Federal Institute for Risk Assessment (BfR). In this context it has developed, together with the Federal Institute for Occupational Safety and Health (BAuA) and the Federal Environmental Agency (UBA), a research strategy to identify the potential risks of nanotechnology. The goal of this research strategy is to structure this research area, to develop methods for the measurement and characterization of nanoparticles, to collect information on exposure, toxicological and eco-toxicological effects, and to promote the development of a risk–based test and evaluation strategy.

When questions about the safety and the potential risks of nanotechnology were becoming increasingly pressing, the BfR in 2006 began to carry out the interdisciplinary research project “Delphi Study on Nanotechnology - Expert Survey of the Use of Nanomaterials in Food and Consumer Products.”  Parts of the study were undertaken in cooperation with the Centre for Interdisciplinary Risk Research and Sustainable Technology Development (ZIRN) of Stuttgart University. The goal of this project was to lay the foundations for future BfR risk assessments of nanotechnology applications.

In September 2010 the results of the BfR Nano Delphi study were published, offering a detailed discussion of each of the basic nanostructured substances currently on the market, as well as across a variety of product uses.   This work is very helpful for those currently tasked with assessing and managing the likely future risks associated with nanomaterial usage.

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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 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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“Nanotoxicology 2010” will be held from June 2nd – June 4th 2010, at Edinburgh Napier University, Edinburgh, Scotland.

Speakers presenting at Nanotoxicology 2010 are an esteemed international group of highly respected nanotechnology experts from industry, government, and academia in the United States, Canada, Europe, and Asia.

The conference will take place over 3 days, and will be divided into sections that allow focus on specific types of nanomaterials including carbon nanotubes (the most commonly used nanomaterial in industrial applications), nanometals (such as nanosilver, increasingly common in consumer products), and nanometal oxides (such as nano-titanium dioxide and nano-zinc oxide, the nanomaterials most widely used in consumer products currently).

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Citing both Canadian and U.S. sources, a recent YouTube-hosted video with the above title was recently posted at the Nanotechnology.org website.

The brief audio/video report (1:17 in length) runs through a number of general media headlines in the past year — such as “U.S. nanotechnology safeguards inadequate” and “Health Canada yet to respond to expert calls for better nanotechnology regulations” — pointing out that “critics warn that not nearly enough is known about how these altered materials might affect the human body and the environment.”

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Currently, the Acts and Regulations administered by Health Canada have no explicit reference to nanomaterial. In recognition of the need to keep pace with advances in this area and to collect information on risks associated with nanomaterials, Health Canada has adopted the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials (IPS)

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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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I want to let you know about two books (both available in paperback) that have some good information about nanotechnology risks to health and the environment.  These would be especially helpful for a non-scientist that wants to get a good sense of the general range of risk issues.

1.  Nanotechnology: Consequences for Human Health & the Environment  

Ronald E. Hester (Editor), Roy M. Harrison (Editor)  

2.  What Is Nanotechnology and Why Does It Matter?: From Science to Ethics

F. Allhoff, P. Lin, and D. Moore

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Although it has received very little notice, the governments of all 53 African countries adopted a resolution concerning nanotechnology safety during the Strategic Approach to International Chemicals Management (SAICM) regional meeting in Abidjan, Cote D’Ivoire, on January 28, 2010.

The non-binding resolution calls on countries creating nanomterials and nanomterial-containing products -- like the United States -- to ban shipments of nanomaterial-containing wastes to countries that lack the capacity to properly and safely manage the materials.

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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 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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The Center for the Study of Law, Science, & Technology (LST) at the Sandra Day O'Connor College of Law at Arizona State University, along with colleagues in Australia and Belgium, have launched the first global database of government documents on nanotechnology. read more

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 new UK-based nanoparticle risk research center was launched this week.  

Edinburgh (Scotland) Napier University's new Centre for Nano Safety has been set up to identify whether a variety of nanoparticles can enter the human body – as well as other species such as bacteria, insects and plants – and cause harm.   The Centre's mission is to study the possible toxicity of nanoparticles, both biotoxocity and ecotoxicity.

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On October 26, 2009, The Advisory Committee on Hazardous Substances to the United Kingdom's Department of Environment, Food and Rural Affairs (Defra), issued a "Report on Nanosilver.”  The Report warns that more information on both the hazards of and exposure to nanosilver is urgently required, and recommended to British agencies that they gather information about products containing nanosilver. 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 October 21, 2009, paper by Germany's Federal Environment Agency (Umweltbundesamt, UBA) triggered fearful headlines in some of the country's biggest newspapers and in the blogosphere:

"German Environment Agency: Don’t use nano-materials!”

“Nanotechnology can make you sick”

“The German Environment Agency warns against nanotechnology”

The paper, "Nanotechnology for Humans and the Environment: Increasing Chances, Minimizing Risks," certainly expresses reservations about nanotechnology. For example, the UBA calls for a register of nanotechnology products and consumer product labeling indicating that a product contains nano-particles. But the paper is cautious in its criticism and certainly not anything close to the near hysteria expressed by some respectable German newspapers and others that have picked up those stories.

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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

On October 5, 2009, the Wisconsin Department of Natural Resources hosted a roundtable discussion with Dr. Andrew Maynard, Chief Science Advisor, Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars in Washington, D.C.

Discussion topics include nanotechnology basics and definitions, manufacturing process and opportunities, regulatory status, and potential environmental and health concerns.
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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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As with any new technology, the earliest and most extensive exposures to engineered nanoparticles are likely to occur in the workplace. Workers may be exposed to nanomaterials during the manufacturing, end use, or during the disposal or recycling of nanomaterial-containing products and workplace exposure levels and frequencies are likely to be higher than that seen in the general environment.   The National Institute for Occupational Safety and Health (NIOSH) is the leading federal agency conducting research and providing guidance on the occupational safety and health implications and applications of nanotechnologies.   Workplace exposure risks associated with the manufacturing of nanomaterials come within the auspices of the Occupational Safety and Health Act, 29 U.S.C. §651 et seq., and the regulations promulgated under the Act.     Maintaining current knowledge of the state-of the art in nanomaterial safety research is imperative for risk managers, insurance professionals, and their attorneys because the Act’s general duty clause requires that an employer must provide each employee with “a place of employment . . . free from recognized hazards that are likely to cause death or serious physical harm.” 29 U.S.C. §654(a)(1).
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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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