Occupational Health & Safety

Eric Rogers, a third-year law student at Michigan State University's Detroit College of Law (and with a B.S. in Engineering Physics), prepared this post.

There are countless cheap and portable devices to measure exposure to well-known environmental hazards in the workplace. How do these machines stack up in our bourgeoning nanotechnology world?  Patrick T. O'Shaughnessy of the University of Iowa explores both the current exposure limits to nanoparticulate matter as well as methods for measuring workplace exposures in his article, "Occupational health risk to nanoparticulate exposure," published in a recent issue of the Royal Society of Chemistry's journal, Environmental Science Processes & Impacts.  The result is not encouraging – at least, not yet.

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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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According to a recent article in the firefighting community publication "Firehouse," the proliferation of nanomaterials in consumer products is making the microscopic materials that become airborne during fires even more deadly than realized

Firefighters and responders have known for decades the dangers of smoke to their health, but the increasing use of nanotechnology in products that burn is adding a different dimension to the danger. 

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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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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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You may be interested in an article published by BNA's Product Safety & Liability Reporter in November 2011: "Labeling and Warning for Products Containing Engineered Nanomaterials: Learning From the Past or We Are Doomed to Repeat It"

The article is a very good collaboration by attorneys William Rogers and Joseph Clark (Day Pitney LLP) and scientists Joyce Tsuji, David Dahlstrom, and Steven Arndt (Exponent), and provides guidance about how to approach the new world of labeling, warning, and instruction creation for products containing nanomaterials.

A few excerpts are provided below, to help you decide whether you want to get the full article.

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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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A new study published in the June 2011 issue of The American Journal of Pathology, "Length-Dependent Retention of Carbon Nanotubes in the Pleural Space of Mice Initiates Sustained Inflammation and Progressive Fibrosis on the Parietal Pleura", shows that carbon nanotubes could pose risks in the occupational setting. The study was conducted by the University of Edinburgh, United Kingdom, and follows previous research in mice looking at the effect of carbon nanotubes on the stomach cavity.

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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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"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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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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Carbon nanotubes and other carbon nanomaterials are now, and are expected to remain, the most commonly used nanomaterial in industrial applications. They are also used in a wide variety of consumer products and that trend is expected to continue. Early research has already raised questions, if not concerns, about the environmental, health, and safety risks of some carbon nanomaterials, such as single-and multi-walled carbon nanotubes.

Twelve (12) leading companies involved in the commercialization of carbon nanomaterials and products recently formed the NanoSafety Consortium for Carbon ("NCC") to address nanoscale carbon environmental, health, and safety issues related to the responsible commercialization of their products.

The NCC website is designed to inform the public about its activities.

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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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“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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Many researchers working with nanomaterials use inadequate protection, if any at all, and most don't use special disposal methods for nanomaterials, claims a new study published January 2010 in Nature Nanotechnology.  The study is discussed in a January 31, 2010, post by Kate McAlpine, at Britain's highly regarded Royal Society of Chemistry, Chemistry World website.  www.rsc.org/chemistryworld/News/2010/January/31011001.asp

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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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 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

A new study published October 25, 2009, in Nature Nanotechnology online --  "Inhaled Carbon Nanotubes Reach the Subpleural Tissue in Mice" --  provides further evidence for the asbestos-like effects of certain types of carbon nanotubes.

The study, by researchers at North Carolina State University, The Hamner Institutes for Health Sciences, and the National Institute of Environmental Health Sciences (all in the United States), found for the first time that multi-walled carbon nanotubes (MWCNTs) reach the outer lining of the lung when inhaled - as asbestos does.  The findings raise concerns that inhaled nanotubes may cause pleural fibrosis and/or mesothelioma.

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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 Research Triangle Environmental Health Collaborative (The Collaborative) will gather 150 experts from around the nation at its second annual environmental health summit on October 8-9, 2009. The 2009 summit, “Environmentally Responsible Development of Nanotechnology,” is being held at the North Carolina Biotechnology Center in North Carolina’s Research Triangle Park.

This year’s summit features a broad and experienced group of participants representing wide areas of expertise and diverse views from Federal, State, and local governments; academia, industry, and public interest organizations. Speakers include Mark Wiesner, of Duke University’s Center for the Environmental Implications of NanoTechnology (CEINT), and Chad Holliday, Chairman of the Board and former CEO of DuPont, Inc.
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Prudent manufacturers, sellers, and employers in the Nanotechnology community must maintain knowledge of all relevant standards, whether governmental or voluntary. Although standards developed by organizations like ASTM International are not government-issued mandatory standards with the force of law, they can be extremely important. In some cases, governments will adopt such voluntary standards, thus giving them legal effect. Even if not, 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.

ASTM International, originally known as the American Society for Testing and Materials (ASTM), is one of the largest voluntary standards development organizations in the world.  In order to make the consensus standards being developed by ASTM more visible to the Nanotechnology community, ASTM now has a new Nanotechnology-focused page on its website.  ASTM standards for nanotechnology provide guidance for nanotechnology and nanomaterials, as well as nanotechnology terminology, property testing, and issues of health and safety.

ASTM has thus far issued one standard concerning Nanotechnology health and safety, the Standard Guide for Handling Unbound Engineered Nanoscale Particles in Occupational Settings, published October 2007.

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The critical importance of exposure assessment as an integral component of risk assessment and risk management of nanomaterials is widely recognized.  Significant effort is now focused on development of methods for characterizing, measuring, and modeling occupational and environmental exposure levels throughout nanomaterial product life cycles.

The International Journal of Occupational and Environmental Health (IJOEH) is seeking submissions for a special issue provisionally titled, “Human and Environmental Exposure Assessment for Nanomaterials,” to be guest edited by Vladimir Murashov, PhD, Special Assistant to the Director, National Institute for Occupational Safety and Health.

The special Nanomaterials issue of the IJOEH originates from presentations and discussions at the U.S. National Nanotechnology Initiative workshop on Human and Environmental Exposure Assessment (http://www.nano.gov/html/meetings/exposure/index.html) held on February 24-25, 2009 in Bethesda, MD.   According to the IJOEH, "The special is issue seeks to make a substantial contribution to the responsible introduction of nanomaterials into commerce by presenting critical data for risk management through state-of-the-science assessments, by identifying critical research gaps, and by facilitating coordinated efforts to address the gaps."

Submit manuscripts at www.ijoeh.com.  For information on the special issue, contact Vladimir Murashov at vladimir.murashov@cdc.hhs.gov.

Submissions must be received by January 15, 2010

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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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