Maura Fleming

Legal Research - Nanotechnology

Legal Issues in the 21st Century

Spring 2007

 

 

The Federal Regulation of Nanotechnology in the United States

 

Nanotechnology is no longer just an interesting hypothesis.  It is a reality.  As of November 26, 2006, the nanotechnology consumer products inventory contained 356 products or product lines.[1]  The largest primary category was “Health and Fitness”, with a total of 229 products, which includes products like cosmetics and sunscreens.  The nanotechnology-based products market is predicted to reach over $2.5 trillion by 2014, or about 15 percent of manufactured goods output.[2]  Yet, to date, no federal agency has enacted any specific regulations directed at nanotechnology.  Most discussions about the regulation of nanotechnology have focused on the adequacy of certain existing regulations and statutes.  However, given the unique properties of nanotechnology and nanomaterials, there is a great deal of debate over how existing regulations might apply.

I. Existing Regulations:

A. Toxic Substances Control Act (“TSCA”)

The TSCA was enacted in 1976 as a way of dealing with public fears regarding toxic chemicals.  Its primary goals were to prevent new chemicals from being marketed without adequate safeguards and to fill gaps in the regulation of existing chemicals.  The TSCA requires manufacturers to tell the Environmental Protection Agency (“EPA”) about new chemicals they want to market and gives the EPA the authority to restrict those chemicals that they view as posing undue risks.  In his report entitled, Managing the Effects of Nanotechnology, J. Clarence (Terry) Davies, a senior advisor to the Project on Emerging Nanotechnologies and a Senior Fellow at Resources for the Future, states that the TSCA’s coverage is quite broad, and is, therefore, currently considered the best law for regulating nanotechnology.  In fact, he states that many environmental groups have called for the regulation of nanotechnology under the TSCA.  Davies finds that the coverage of the TSCA is broad in two respects.  One is that it is not limited to covering a specific part of the environment, i.e. air, water, etc.  He views this as appropriate for regulating nanotechnology materials and products as the effects of such will most likely not be limited to a specific part of the environment.  Second, the law is directed at “chemical substances and mixtures” broadly defined as “any organic or inorganic substance of a particular molecular identity” (TSCA sec. 3(2)(A)).[3] 

Davies’ report goes on to discuss other provisions of the Act, which would bring nanotechnology materials under the regulatory oversight of the TSCA.  However, he cites several problems with having the TSCA, as it stands now, as the regulatory scheme for governing nanotechnology.  For example, under TSCA's "low volume" clause, chemicals made in quantities of 11 tons or less are, for the most part, exempt from regulation.  This may be appropriate for regulating conventional chemicals but is not necessarily appropriate for regulating nanomaterials.  Given the extreme chemical reactivity of nanomaterials, the fact that relatively small quantities are being made is hardly an assurance of safety.[4]  Furthermore, because most nanomaterials are ordinary chemicals that differ only in their particle size, manufacturers have been avoiding TSCA restrictions by classifying their products as conventional chemicals, even though their tiny size is precisely what makes them different, which means that quantity or volume may not be a relevant indicator of potential risk.[5]  The EPA, which favors a "voluntary" regulatory regimen for nanotechnology, has not yet decided how to deal with that loophole.[6]

2. Occupational Safety and Health Act (“OSHAct”)

The OSHAct was passed in 1970.  The Act combined the occupational safety programs from the Department of Labor with the occupational health functions exercised by the Department of Health, Education and Welfare (now Health and Human Services). The Department of Labor was given the responsibility for administering the OSHAct. The OSHAct’s basic mechanism is for the Occupational Safety and Health Administration (“OSHA”) in the Department of Labor to set standards and to enforce the standards through inspections and penalties for noncompliance.[7]  An occupational safety and health standard is defined in the Act (sec. 3(8)) as “ a standard which requires conditions, or the adoption or use of one or more practices, means, methods, operations or processes, reasonably necessary or appropriate to provide safe or healthful employment and places of employment.”[8] 

In his report, Davies states that this language is certainly broad enough to cover nanotechnology.  However, the difficulties with using the OSHAct to deal with nanotechnology are the same that arise with most of the environmental statutes.[9]  The equipment required to detect nanotechnology products is expensive and sophisticated, and it is often unclear which parameters are the relevant ones to measure from the standpoint of toxicity.[10]  For practical purposes, whether in the setting of a factory or the ambient environment, detection and control methods (e.g., filters) may not be currently

available or may be too expensive or too cumbersome.[11]  Davies also notes that OSHA like other federal agencies is lacking the resources to adequately deal with nanotechnology.  In 1980, there were 2,950 OSHA employees, while in 2005, there were only 2,208.  With the millions of workplaces in the United States, Davies believes that the chance of being visited by an OSHA inspector is not high, and therefore does not provide adequate protection for workers.

3. Food, Drug, and Cosmetic Act (“FDCA”)

The FDCA is a one-hundred-year-old Act originally passed to prevent poisonings from quack patent medicines and to clean up grossly unsanitary conditions in food processing plants.[12]  Over the years, it has been frequently amended, expanding its coverage.  There are five types of nanotechnology applications that fall under the FDCA: drugs, medical devices, biologics, cosmetics and food.  Medical devices are basically any mechanical thing used for treatment or diagnosis of disease.  Drugs, biologics and medical devices are regulated quite differently from cosmetics.  Drugs, biologics and medical devices must receive approval from the Food and Drug Administration (FDA) before they can be sold.[13]  In his report, Davies contends that the approval process is both time-consuming and rigorous.  Under the FDCA, it is up to the manufacturer to prove that the product is safe, and, overall, the process for approving drugs, biologics and medical devices works reasonably well.

However, Davies views cosmetics as a different story.  Although the FDCA has a lot of language devoted to cosmetics, he states that it is not much of an exaggeration to say that cosmetics in the United States are essentially unregulated.[14]  The FDCA prohibits the marketing of “adulterated or misbranded” cosmetics in interstate commerce.  “Adulterated” is roughly defined as injurious to health.  “Misbranded” means that the label is false or misleading or does not contain required information.  However, the manufacturers of cosmetics are not required to register with FDA, are not required to file data on product ingredients, and are not required to report cosmetic-related injuries to FDA.[15]  Moreover, if the FDA does discover a cosmetic that is adulterated or misbranded, it has no authority to recall the product or take action against the manufacturer. All the FDA is able to do is ask the Justice Department to bring suit to have the product removed from the market.  Davies states that in light of these facts, it appears that nanotechnology based drugs, biologics and medical devices, and probably nanotechnology-based food additives and packaging, are best regulated under the FDCA authorities.[16]  On the other hand, although it would be neater legally and bureaucratically to regulate nanotechnology cosmetics under the FDCA, Davies believes that the public would be better protected by regulating cosmetics under some alternative regime.[17]

4. Environmental Laws

There are at least one hundred environmental laws.  The vast majority of which deal with very specific, narrow subjects, or they are minor amendments to existing laws. According to Davies’ report, the three major environmental statutes are the Clean Air Act (“CAA”), the Clean Water Act (“CWA”) and the Resource Conservation and Recovery Act (“RCRA”).[18]  The basic mechanism of the CAA and the CWA is to set standards and to enforce them through permits issued to pollution sources.[19]  However, Davies points out that these laws face the same problems in dealing with the possible adverse affects of nanotechnology as the OSHAct.  It is difficult to detect nanotechnology materials except with sophisticated laboratory equipment, and, if these materials cannot be detected, the provisions of the environmental laws are ineffective.

The one environmental law provision that has been considered in the nanotechnology context is the CAA standard for fine particulates.[20]  This standard sets limits on the amount of particulates less than 2.5 micrometers in diameter that can be present in the ambient air (2.5 micrometers is equal to 2.5 thousand nanometers).[21]  In other words, a 100-nanometer-wide particle, the largest nanotechnology particle by the usual definition of nanotechnology, is 1/25 of the small particle CAA standard.[22]  The CAA standard, like almost all environmental standards, is premised on a direct relationship between volume or concentration on the one hand, and risk on the other, and Davies contends that the relationship may not be valid for regulating nanotechnology.[23]

II. Going forward:

The regulations discussed above are but a few that are being considered for regulating nanotechnology.  With no definite solutions, it appears that, for the time being, the United States government is determined to fit the regulation of nanotechnology into one or several of these existing regulatory schemes.  In January 2006, in response to Davies’ report, the FDA reiterated that existing regulations are "probably adequate for most nanotechnology products."[24]  In August 2006, the FDA created the FDA Nanotechnology Task Force.  It is charged with determining regulatory approaches that encourage the continued development of innovative, safe, and effective FDA-regulated products that use nanotechnology materials.[25] 

In February 2007, the EPA released a White Paper on nanotechnology and related regulatory issues.  The stated purpose of the White Paper is to inform EPA management of the science issues and needs associated with nanotechnology, to support related EPA program office needs, and to communicate these nanotechnology science issues to stakeholders and the public.[26]  As to the subject of the regulation of nanotechnology by the EPA, the White Paper explains that the EPA maintains the position that current environmental statutes provide it with the authority to regulate nanomaterials.[27]  

However, the scientists and scholars on the Project on Emerging Nanotechnologies[28] continue to urge the United States government to consider new laws or modifications to existing laws in order to deal with the complexities of nanotechnology.  Of primary concern, is the allocation of additional funding towards evaluating the potential risks of nanotechnology.  In January 2007, Dr. Andrew Maynard, the chief scientist on the Project on Emerging Nanotechnologies, provided testimony at the federal government’s first public meeting focused exclusively on research needs and priorities for the environmental, health and safety risks of engineered nanoscale materials.  In his testimony, he noted that “despite investing more than $1 billion annually on nanotechnology research, U.S. government spending on highly relevant nanotechnology risk research is only $11 million per year”.[29]  Dr. Maynard went on to say that if people are to realize nanotechnology’s benefits, in medicine, communications, and energy production, the federal government needs a master plan for identifying and reducing potential risks.[30]  Dr. Maynard suggests that this plan should include a top-down risk research strategy, sufficient funding to do the job, and the mechanisms to ensure that resources are used effectively.[31]  It seems that the debate is far from over.

On an interesting final note, in December 2006, Berkeley, California, became the first city in the United States to enact nanotechnology regulation.  The City Council's unanimous action compels researchers and manufacturers to report what nanotechnology materials they are working with and how they are handling the tiny particles.[32]



[1] See Inventory of Nanotechnology Consumer Products, Washington, DC, Project on Emerging Nanotechnologies, Woodrow Wilson Center for Scholars, 2006, http://www.nanotechproject.org/

consumerproducts (last visited April 5, 2007).

[2] Dr. Andrew Maynard, Weighing Nanotechnology’s Risks, International Herald Tribune, http://www.iht.com/articles/2007/03/28/opinion/edmaynard.php (last visited April 5, 2007).

[3] See J. Clarence (Terry) Davies, Managing the Effects of Nanotechnology, Washington, DC, Project on Emerging Nanotechnologies, Woodrow Wilson Center for Scholars, 2006, http://www.wilsoncenter.org/

events/docs/EffectsNanotechFINAL.pdf (last visited April 5, 2007).

[4] See Id.

[5] See Id.

[6] See Id.

[7] See Id.

[8] See Id.

[9] See Id.

[10] See Id.

[11] See Id.

[12] See Id.

[13] See Id.

[14] See Id

[15] See Id.

[16] See Id.

[17] See Id.

[18] See Id.

[19] See Id.

[20] See Id.

[21] See Id.

[22] See Id.

[23] See Id.

[24] Rick Weiss, Stricter Nanotechnology Laws Are Urged: Report Warns Of Risk to Public, http://www.washingtonpost.com/wp-dyn/content/article/2006/01/10/AR2006011001520.html?

nav=rss_nation (last visited April 6, 2007).

[25] See http://www.fda.gov/nanotechnology/ (last visited April 6, 2007).

[26] See U.S. Environmental Protection Agency Nanotechnology White Paper, http://www.epa.gov

/osa/pdfs/nanotech/epa-nanotechnology-white-paper-final-february-2007.pdf. (last visited April 8, 2007).

[27] See Id.

[28] See (www.nanotechproject.org) (last visited April 8, 2007).

[29] See Nanotech Safety Needs Specific Government Risk Research Strategy and Funding, Washington, DC, Project on Emerging Nanotechnologies, Woodrow Wilson Center for Scholars, 2006, http://www.wilsoncenter.org/index.cfm?topic_id=166192&fuseaction=topics.item&news_id=214674 (last visited April 8, 2007).

[30] See Id.

[31] See Id.

[32] Associated Press, Berkeley first city in nation to regulate nanotechnology, available at http://www.sfgate.com/cgi-bin/article.cgi?f=/n/a/2006/12/13/state/n114901S34.DTL (last visited April 8, 2007).