Nanotechnology is the science of the very small. It involves the design and implementation of devices, products and systems that are measured in nanometers, a unit equal to one-billionth of a meter. To put this in perspective, the button on a dress shirt is approximately 10 million nanometers across, A human hair is approximately 100,000 nanometers thick. By contrast, most nanoscale particles measure less than 200 nanometers. These "nanomaterials" are used in very small quantities, are difficult to measure and react quite differently than the same element at normal scale. Their unique chemical and physical properties lure scientists and engineers who see their enormous potential to create new and better products for a variety of markets. These same properties, however, cause concern for regulators, legislators, environmentalists and activists who fear the effects on human and environmental health. 

Nanotechnology promises to bring significant changes to many products and industries. The National Science Foundation estimates that the global value of goods that contain nanomaterials will reach $1 trillion by 2015. Nanomaterials are being used in industries as diverse as pharmaceuticals, semiconductors, cosmetics, textiles, energy, chemicals and food processing. The Woodrow Wilson International Center for Scholars recently published a report that counts more than 600 consumer goods containing nanomaterials. 

Materials that are benign at the normal scale may present health issues at the nanoscale. For example, silver is a familiar metal used in many industrial, commercial and consumer applications. We handle it, use it and wear it without concern. Yet, at the nanoscale, silver has antimicrobial properties that are valuable for many medical and consumer applications. With expanding use, there is increased concern that substantial releases of silver nanoparticles may be harmful to the environment and possibly to humans if introduced or released in sufficient quantities. 

While the body of regulations for chemicals, toxic substances, workplace safety and the environment is fairly robust, it is the dichotomy between the chemical and physical properties of materials at the normal scale versus nanoscale that have regulators concerned that existing regulations do not adequately address the issues that nanoscale materials present.

Today, regulation of nanomaterials is just beginning to take shape, and environmental health and safety (EH&S) issues are now dominating nanotech literature, causing uncertainty for manufacturers, insurers, the legal community and the public alike. 

EH&S Regulations

Officials in the United States, European Union and Japan are attempting to use or modify existing regulations for hazardous chemicals to regulate nanomaterials. Generally this makes sense as nanomaterials are mostly specialty forms of chemicals. Currently, the biggest regulatory concerns are worker exposures to potentially hazardous materials and releases of nanomaterials into the environment through wastewater or other forms of disposal. In the United States, the Environmental Protection Agency (EPA) and the Occupational Safety and Health Administration (OSHA) are taking the lead. In the European Union, the responsibility falls to the European Chemical Agency (ECHA). In Japan, the Ministry of Economy Trade & Industry (METI), the Ministry of Health, Labor & Welfare (MHLW) and the Ministry of the Environment (MOE) are working jointly to develop regulations. 

In all regions, regulators are currently applying toxic substance control regulations to nanomaterials and treating them as chemicals. Regulations governing toxic chemicals are the best place to research applicable regulations to nanotechnology, however regulators are becoming increasingly aware of the differences in properties between engineered nanomaterials and traditional chemical substances. Due to this, regulatory amendments and revisions specific to nanomaterials are expected.

Workplace Safety

The general duty clause under the Occupational Safety and Health Act requires employers to provide employees with a safe working environment free from recognized hazards. This general duty applies to work areas that may have exposures to nanomaterials.  "Although there are not occupational safety and health standards specifically designed to address potential risks from handling nanomaterials, employers should be aware of OSHA regulations that are generally applicable to manufacturing, processing, distribution or disposal operations, which may have nano-specific implications," said Paul Sarahan, specialist in environment law with Fulbright and Jaworski. 

The act also has extensive requirements governing the handling of, and exposure to, hazardous chemicals. The definition of a hazardous chemical is fairly broad. The employer has the burden of conducting a review of the scientific literature to determine if the nanomaterials being handled are shown to be a hazard to human health. The difficulty for risk managers is that the literature on the health effects of nanomaterials is sparse. These materials are so new that scientists and researchers have not had time to conduct the studies needed to determine their health effects. Unfortunately, this lack of knowledge does not absolve the employer of providing a safe workplace. 

At present, it is probably best to appreciate that there is a potential for health hazard and act accordingly. Also, let's be clear: the literature mentioned in the OSHA regulation is generated by academics and government researchers, many of whom are now seeking government funding to conduct studies of nanomaterials to fill in gaps in their general knowledge of nanomaterials toxicology. 

While we wait for their research results and conclusions over the next several years, there are private companies already providing toxicology testing and EH&S risk assessments for specific nanomaterials used in well-defined and practical applications. Due to the proprietary nature of these nanomaterials, these toxicological results are usually confidential and rarely published, but essential information can be obtained by contracting these companies to assess your developing nanotechnology and workplace to identify and eliminate any potential hazards. So it is not necessary to wait for academic publications to catch up to industry, especially when it involves workplace safety.

Despite the uncertain risks associated with nanotechnology, the National Institute for Occupational Safety and Health (NIOSH) has also weighed in on worker safety in February 2009, with its paper, "Interim Guidance for Medical Screening and Hazard Surveillance for Workers Potentially Exposed to Engineered Nanoparticles." NIOSH recognized that "there is insufficient scientific and medical evidence to recommend the specific medical screening of workers potentially exposed to engineered nanoparticles." They recommended that employers implement common-sense steps in environments where workers may be exposed to engineered nanoparticles, such as: (1) take prudent measures to control exposures to engineered nanoparticles, (2) conduct hazard surveillance as the basis for implementing controls, and (3) continue to use established medical surveillance programs. 

While a review of the EH&S literature on any one nanomaterial may not provide much guidance to the risk manager, a risk assessment accompanied by any follow-up toxicology testing and corrective action will do much to protect the company from future regulatory sanction or tort litigation. Good data, good records and good precautionary measures are key.

Environmental Regulations

In the interest of environmental safety, the EPA is applying rules under the Toxic Substance Control Act (TSCA) to nanomaterials. Under TSCA, the EPA can require manufacturers to test chemicals for their effects on human health or the environment if it deems there is reasonable cause to suspect a potential hazard from the chemical. In addition, TSCA requires that if a manufacturer, processor, importer or distributor of a nanoscale version of a chemical learns that there are potential hazards different from the bulk version of that chemical, the company is compelled to report it to the EPA. 

TSCA also gives the EPA authority to regulate "new chemical substances" or apply the "significant new use rule" (SNUR) to an existing chemical. The determination of "significant new use" does not have specific criteria, but some of the most common determinants are changes in the volume of manufacture, changes in use that alter the exposure to humans or the environment and the extent to which the change increases the magnitude of exposure to humans or the environment. If the EPA determines that a chemical qualifies under the SNUR, then all the steps necessary for approving any other new chemical substance are applicable, such as submitting a pre-manufacturing notice.

While these SNUR factors are the same for any chemical, the question being raised by the regulators and other interested parties is when to apply SNUR to a nanoscale version of a chemical already listed in the TSCA Inventory. (The TSCA Inventory is a list of approximately 80,000 chemical substances that are processed, manufactured or imported in the United Sates.) 

Certain environmental groups argue that, by definition, the nanoscale version of a chemical is "new" in that it potentially has new chemical characteristics. Other parties believe that at the molecular level, silver is silver and carbon is carbon, making the application of SNUR inappropriate. The EPA has not issued any broad rules with respect to treating nanoscale versions of existing chemicals as "new." 

That said, in October 2008, the EPA notified manufacturers of carbon nanotubes that these products are distinct from graphite and other forms of carbon. Carbon nanotube manufacturers will be required to submit a pre-manufacturing notice and follow all of the steps necessary to gain regulatory approval before distributing their products. 

In addition, the EPA specified two different siloxane-modified nanoparticles as clearly "new use" and distinct from similar chemicals in the TSCA inventory. While two rulings do not make a trend, it does seem to indicate the EPA is leaning toward the side of caution. In the European Union, ECHA is applying similar regulations.

Risk managers must also be cognizant that chemicals or substances that do not qualify under TSCA as hazardous in the normal scale may well be classed as a SNUR or a new chemical in the nanoscale. Several activist groups are pressuring the EPA to classify nanoscale silver as a toxic substance under TSCA or as a pesticide (therefore toxic) under the Federal Insecticide, Fungicide, Rodenticide Act, depending on its application. 

Be aware that even if you do not manufacture nanomaterials, some of your suppliers might use nanomaterials in the components you buy from them. Most often, a nanomaterial that is included in another matrix (as an additive, coating or the like) does not present an EH&S issue-unless that component is being altered in your manufacturing process, such in grinding, cutting, drilling or welding. In these instances, there may be a release of nanoparticles in sufficient quantities to warrant preventative measures.

In the European Union, the ECHA is applying toxic chemical standards under REACH (Registration, Evaluation, Authorization and Restriction of Chemical substances) regulations to nanomaterials. In addition, the Organization for Economic Cooperation and Development (OECD) has published a list of approximately 20 nanomaterials that it classifies as "of concern" and is working on programs to test these materials. In tandem with this list, the EU assembly voted in March 2009 to require more stringent safety rules for the use of nanomaterials in cosmetics and will apply a "safety first" precautionary standard before approving products for market.

In Japan, regulators have published guidelines for the safe use of nanomaterials along the same lines as those now in effect in the United Sates. According to one of the co-authors, the Japanese plan is to use a voluntary reporting program similar to that tried by the EPA under its Nano Material Stewardship Program. The closer relationship between government and industry in Japan will likely yield a higher degree of voluntary compliance than in the United States.

Protecting Your Company

While much is made about the uncertain state of regulation of nanomaterials, many existing workplace and environmental regulations apply and need to be complied with. Even if the regulations are not explicit, there is the expectation that a company will act in accordance with state of the industry standards when it comes to protecting employees and the general public. "Industry is better off being proactive in its response to these emerging concerns-collecting its own data on the safety of its products...and providing this information to the EPA and other concerned regulatory bodies," said toxicologist David Hobson in a May 2009 article in the magazine Controlled Environments. 

Nanoparticles are not new. They were present naturally long before humans existed and we are exposed to them continuously in forms that are essentially harmless. It is the engineered (man-made) nanoparticles that are causing concern among regulators. Some toxicologists have many decades of experience testing and evaluating natural nanoparticles (volcanic ash, atmospheric dust and ocean spray) and nanoparticles produced as a result of human activity (diesel exhaust, fly ash, jet fuel exhaust and many others). Risk assessment procedures, testing protocols and specific assays are well known and can be reliably applied to evaluate the health effects of a new, engineered nanoparticle. 

Given good quality data from well-designed toxicology protocols in a nanoproduct-specific risk assessment, companies manufacturing or using nanomaterials will know what (if any) potential exposures exist. Using that knowledge, they can implement appropriate design changes, protective measures and other economical practices and policies to protect workers, customers and the public, as well as the interests of the business. 

"Safety first" is the best defense from regulatory action or litigation. A safety data dossier with good data and good records supporting the risk assessment results regarding nanotechnology is the best way to show compliance with the letter and intent of current and emerging regulations. n

Written by Gregory E. King:

Gregory E. King is chief operating officer for nanoTox, Inc., a provider of confidential risk assessment for nanotechnology.

The above article is reprinted from the April 2010 edition of Risk Management Magazine