Laws & Regulations

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The U.S. Food and Drug Administration in April 2012 issued two draft guidance documents relating to the use of nanotechnology in food and food packaging and cosmetics.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These draft guidance documents are the subject of a summary article by attorney Lynn Tyler (Barnes & Thornburg LLP), published in Product Liability Law360, on May 29, 2012,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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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 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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The recent EU Cosmetic Products Regulation includes a labeling obligation for nanomaterials in the list of ingredients, in order to allow consumers to make a choice.  Similar provisions are now being considered for other regulations/ directives, e.g. the Novel Foods Regulation. Also the European chemicals legislation REACH may need adjustments to address and control the potential risk of nanomaterials.

The introduction of these provisions specific to nanomaterials requires the adoption of a definition of the term ‘nanomaterial’. This need is also acknowledged by a European Parliament resolution from 20090 which has called for a comprehensive science-based definition in Community legislation.

An excellent discussion of the subject, and real progress on the issue, is reflected in a new European Commission Reference Report, “Considerations on a Definition of Nanomaterial for Regulatory Purposes.”

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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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This conference on Monday, March 21, 2011, in Phoenix, promises to be interesting.

After several years of studying the risks of nanotechnologies, federal agencies such as EPA, FDA and NIOSH are now moving forward with more aggressive regulation, and a variety of other non-regulatory risk management and safety initiatives have been proposed or implemented.

The 2011 conference will examine recent trends and challenges in regulation and risk management of nanotechnology. Top national and international nanotechnology experts from government, industry, non-governmental organizations, the insurance industry, and academia will be featured.

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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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Nanotechnology is transforming product design and innovation among manufacturers of electronics goods, textiles, cosmetics and foodstuffs as well as in other fields of materials science.  However, for insurers, uncertainty still surrounds the increasing use of nanotechnology in products and how safe they are.

  An October 6, 2010, article by Lloyd's of London, one of the world's largest insurance markets, discusses the concerns.  

  An article in the October 7 on-line edition of Insurance Journal also discusses the Lloyd’s article.

Excerpts from the Lloyd's on-line article, “Regulators get to grips with nanotechnology,” are reproduced 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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"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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I recommend that you add to your “nanolinks” for regular reading the NanoLaw Blog, hosted by Widener University Law School.

The NanoLaw Blog Mission Statement: Nanotechnology has been around for a while, but it is becoming more pervasive as new products and applications appear. The National Nanotechnology Initiative lists developing uses as diverse as cancer treatments, nerve regeneration, efficient solar energy, and both industrial and consumer product enhancement. Notwithstanding this burst of technological ingenuity, the impact of nanotechnology on human health and the environment has been only sparsely studied, and nanotechnology is virtually unregulated in the United States. Without information regarding the impacts of nanotechnology, agencies entrusted with making regulatory decisions regarding applications that use the technology – such as OSHA, FDA, and EPA – cannot effectively regulate. As an emerging technology with unknown risks, nanotechnology is likely to follow the path of other toxic torts in the areas of both private law and public law. The purpose of this site is to raise legal questions about the impact of nanotechnology and comment upon the ways in which those questions are likely to be raised in the legal system.

With the permission of the NanoLaw Blog I have below reproduced one of the recent posts, an interesting discussion of the legal significance of early nanomaterial studies of environmental, health and safety. You will find it interesting.

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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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Prudent manufacturers, sellers, and employers in the nanotechnology community must maintain knowledge of all relevant standards, whether governmental, NGO, or industry-developed.  But there is frustration with the uncertainties about the regulatory definitions of chemicals, materials, and products made with nanotechnologies.

This is an area worth watching closely.  The current confusion and likely permanent lack of complete uniformity with respect to nanotechnology and nanomaterial definitions and related standards also has tremendous implications those corporate officials and lawyers with responsibility for managing and minimizing risk, including litigation risk.  Evidence of compliance or noncompliance can have a powerful impact in personal injury litigation regarding issues of state of the art, negligence, recklessness, and punitive damages.

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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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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 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

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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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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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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