Nanogovernance: Federal Progress on Regulating Tiny Technology

Nanotechnology is a “wicked” policy problem, according to the Project on Emerging Nanotechnology. ¹D.J. Fiorino, Voluntary Initiatives, Regulation, and Nanotechnology Oversight, Project on Emerging Nanotechnologies (2010).

Industry has long been frustrated by the pace of regulatory review of nanomaterials. Environmentalists are concerned that the government is rushing to embrace new technology without adequately assessing potential risks to human health and the environment. The White House argues that “[a]dvances in nanotechnology can drive economic growth, create quality jobs, and address a broad range of national challenges.” ²J.P. Holdren et al., Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials, Executive Office of the President, 2011. Others argue that nanotechnology research and development has advanced faster than the capacity of regulators to assess its social and environmental impact. ³See, e.g., Linkov et al., Nano Risk Governance: Current Developments and Future Perspectives, 6 Nanotechnology Law & Business 203 (Summer 2009).

While the debate continues, more and more consumer products are created and marketed without regulatory scrutiny. A recent survey found nanomaterials in more than 1,300 consumer products, produced by nearly 600 companies in 30 countries. Almost none of these products have been registered with the Food and Drug Administration or the Environmental Protection Agency, according to the Project on Emerging Nanotechnologies, a nonprofit dedicated to promoting nanotechnology development and minimizing its risks. ⁴The Project on Emerging Nanotechnologies,
On-Line Inventory of Nanotechnology-Based Consumer Products available at http://www.nanotechproject.org/inventories/consumer/.

Carbon nanotubes and nanoscale clays can make cars lighter and stronger; perform environmental remediation; reduce air pollution; create petroleum-free paper coatings; increase the efficiency of solar power; increase the effectiveness of pesticides, herbicides, and fertilizers; and make stronger, more durable construction materials. The use of nanotechnology could produce ‘microbatteries’ that would be smaller, cost less, and be more powerful that what is possible with current technology. Many other innovations to more efficiently generate and transmit energy, protect food from salmonella and other bacteria, and enhance electronics are in development. But regulatory agencies have a limited understanding of the potential for nanomaterials to adversely affect human health and the environment, ⁵GAO, Nanotechnology: Nanomaterials are Widely Used in Commerce, but EPA Faces Challenges in Regulating Risk (2010). causing consumer groups to worry that unanswered health and safety questions could have scary answers. ⁶See, e.g., Consumer Reports Health.org.

The president’s 2012 budget proposal would allocate $2.1 billion to nanotechnology research and development, but only a fraction of that spending ($123 million) would be used for health and safety research. ⁷Executive Office of the President, National Nanotechnology Initiative (NNI) Supplement to the President’s Budget for Fiscal Year 2012 (2011). This dichotomy highlights the tension between federal regulators’ duty to identify and protect public health and safety from the risks of nanotechnology and administration and industry desire to spur economic development.

I. Risks

“Assessment of risk of harm to individuals requires understanding of the inherent toxicity of the material to which they are exposed and the dose delivered to the target organ,” Anthony Seaton and co-authors wrote in a 2009 article for the Journal of the Royal Society.
⁸A. Seaton et al., Nanoparticles, Human Health Hazard and Regulation, The Royal Society 7, 2009, citing Donaldson et al., Ultrafine Particles: Mechanisms of Lung Injury, Phil. Trans. R. Soc. (2000). However, it is unclear whether current risk assessment processes have adequate sensitivity and validity to measure the potential toxicity of nanomaterials. ⁹H. Bouwmeester et al., Review of Health Safety Aspects of Nanotechnologies in Food Production, Regulatory Toxicology and Pharmacology 53 (2009). EPA and FDA working group reports have highlighted these problems, as has GAO. ¹⁰EPA, Draft Nanotechnology White Paper (2005); FDA, Nanotechnology—A Report of the U.S. Food and Drug Administration Nanotechnology Task Force(2007); GAO Supra at 4.

Nanoparticles are very different from their bulk counterparts in large part because their small size presents a very high surface-to-volume ratio. This modifies the physiochemical, reactive, and electrical properties of the materials. ¹¹J. R. Peralta-Videa et al., Nanomaterials and the Environment: A Review for the Biennium 2008-2010, Journal of Hazardous Materials 186 (2011). Nanoparticles “have a more pronounced effect on inflammation, cell damage and cell stimulation than an equal mass of particles of the same materials of greater size,” Seaton wrote. ¹²Supra, note 8. “Even an apparently low toxicity surface has the ability to generate free radicals and oxidative stress in cells.” ¹³Seaton Id., citing Brown et al., Size-Dependent Pro-Inflammatory effects of ultrafine polystyrene particles: A Role for Surface Area and Oxidative Stress in the Enhanced Activity of Ultrafines, Toxicol. Appl. Pharmacol. 175 (2001).

Nano copper oxide is as much as 50 times more toxic to crustaceans, algae, protozoa, and yeast, than its bulk counterpart. ¹⁴A. Kahru, H.-C. Dubourguier, From Ecotoxicology to Nanoecotoxicology, Toxicology 269 (2010.), citing Heinlann et al., 2008, Arujoa et al., 2009, Mortimer et al., 2010, Kasemets et al. 2009. Nanosilver has been found to decrease the viability of cells that play important roles in the immune system. ¹⁵E.J. Park et al., Silver Nanoparticles Induce Cytotoxicity by a Trojan-Horse Type Mechanism, Toxicology in Vitro 24 (2010). Carbon nanotubes can produce inflammation and fibrosis in the peritoneal cavity similar to that produced by asbestos fibers. ¹⁶K. Donaldson et al., Asbestos, Carbon Nanotubes and the Pleural Mesothelium: A Review of the Hypothesis Regarding the Role of Long Fibre Retention in the Parietal Pleura, Inflammation and Mesothelioma, Particle and Fibre Toxicology 7, 2010. Similarly, nanomaterials can act as “Trojan horses” in the intestines. They can transport toxins into the intestinal mucosa, increasing toxic exposure the intestinal lining. ¹⁷Supra note 9. Nanoparticles can also travel through the circulatory system. Some become sequestered in the liver and spleen, but little is known on the capacity of these organs to metabolize and excrete the particles. ¹⁸Id.

Nanoparticles can facilitate the entry of pollutants into cells, with potentially toxic effects. Nanoparticles can penetrate cell walls and membrane barriers and transport other toxics into cells. For example, the antimicrobial mechanism of silver nanoparticles may cause membrane damage because free radicals are derived from the particles’ surface. ¹⁹Supra note 14, citing Kim et al., 2007.

Nano-formulated food additives could result in high consumer exposure to these engineered materials. In addition, residues of pesticides containing nanomaterials might be present in products as consumed, and food can be contaminated when nanomaterials are incorporated into food packaging. It is difficult to determine the amount and characterization of nanoparticles present in food products, because there are few methods for detecting nanoparticles in food matrices. ²⁰Supra note 9.

II. Protecting Public Health

EPA, FDA, and the Consumer Product Safety Commission have oversight of nanomaterials in commerce, including those in consumer products. Federal efforts to regulate nanomaterials have been hampered by the scarcity of risk assessment data. A 2010 report, Draft Environmental Health and Safety Research Strategy, issued by the National Nanotechnology Initiative, the federal government’s interagency program for coordinating research and development, noted critical data gaps:

•  Information about nanomaterials manufacturing, processing, and direct use in consumer products;

•  Understanding environmental exposures, including principal sources of exposure and exposure routes; and

•  Potential for environmental and occupational exposure to human populations and potential adverse health outcomes.

The report stressed that industry should provide adequate information to enable sound regulatory and consumer decisionmaking, and “provide … the public information on how much of what kinds of materials are being produced for what uses.” ²¹National Nanotechnology Initiative, 2011 Environmental, Health, and Safety Research Strategy (2010).

Frustrated with the pace of FDA nanogovernance, in January 2010, several senators introduced a bill (S. 2942) to amend the Federal Food, Drug and Cosmetic Act to establish a nanotechnology program, but the bill was never enacted. Arguably the statutes EPA, FDA, and CPSC implement provide an adequate regulatory basis for protecting public health and safety and the environment. ²²See e.g., M.N. Duvall & A.M. Wyatt, Using TSCA for ‘Existing’ Nanomaterials: The Case for Significant New Use Rules, BNA’s Chemical Regulation Reporter, March 2, 2009 (33 CRR 205, 3/2/09). However, these agencies have been slow to develop and implement regulatory frameworks. EPA administers the laws that regulate pesticides and other chemicals. In addition, while the agency believes industry has failed to apply for registration of many of the substances containing nanomaterials that should be registered, it has targeted this problem with only limited enforcement. In its 2007 report, the FDA Nanotechnology Task Force observed that FDA has limited authority over many consumer products. CPSC, meanwhile, has no pre-market registration authority. ²³FDA Nanotechnology: A Report of the U.S. Food and Drug Administration Nanotechnology Task Force (2007).

GAO sternly criticized EPA’s regulatory program in its May 2010 report. ²⁴Supra note 5. The report asserted that EPA’s current practices raise concerns that nanomaterials are entering the market without adequate scrutiny. EPA is developing rules under the Toxic Substances Control Act and the Federal Insecticide, Fungicide, and Rodenticide Act to establish registrations and reporting requirements for nanoscale materials. For chemicals regulated under TSCA, EPA plans to issue a data call for information about production volume, methods of manufacture and processing, releases and exposure, and available health and safety data. EPA believes “the proposed reporting of these activities will provide EPA with an opportunity to evaluate the information and consider appropriate action under TSCA to reduce any risk to human health or the environment.”
²⁵EPA, Spring Semiannual Regulatory Agenda (2010). EPA submitted the proposed reporting rule for Office of Management and Budget review Nov. 22, 2010. OMB has not indicated when it will approve the rule for notice and comment.

EPA proposed a data collection on nanomaterials in pesticides products June 17. ²⁶76 Fed. Reg. 35,383, Pesticides; Policies Concerning Products Containing Nanoscale Materials; Opportunity for Public Comment (2011). The Federal Register notice explains that it is the agency’s “statutory obligation to determine whether the registration of a pesticide may cause unreasonable adverse effects on the environment.” EPA said the data collection will help it develop policies on when “the presence of a nanoscale material in a pesticide is grounds for EPA to consider the possible need for data to characterize the potential of the ingredient to pose risks.” The TSCA and FIFRA data collections are only the first steps toward regulating unregistered nanomaterials in chemicals and pesticides.

To date few pesticides or chemicals have been formally evaluated under TSCA or FIFRA. One application of nanosilver as a pesticide and three applications of carbon nanotubes have been registered. HeiQ AGS-20, a silver-based product, produced by the Swiss manufacturer HeiQ Materials AG and used as a materials preservative additive to coatings, polymers and textiles, was conditionally registered in August 2010. ²⁷EPA, Proposed Decision Document for the Registration of HeiQ AGS-20 as a Materials Preservative in Textiles (2010). See also, P. Rizzuto, EPA Proposes Conditional Approval of Nanoscale Silver to Treat Textiles, BNA’s Chemical Regulation Reporter, Aug. 23, 2010 (34 CRR 831, 8/23/10). EPA issued the conditional registration with the requirement that HeiQ Materials develop additional risk assessment data. The agency’s decision document states: “Use of the pesticide during the period that the newly required data is being developed and reviewed by the Agency will not cause unreasonable adverse effects” and “considerations relating to market equity and international trade and promoting innovation lend further support to a determination that a conditional registration is in the public interest.” HeiQ Materials will be required to conduct studies to identify potential toxicological effects, assess environmental fate and transport, study potential leaching from treated items, and more completely characterize the product.

Three distinct carbon nanotube structures have been registered with EPA through the TSCA pre-manufacture notice process. As a result of its rigorous review of the potential hazards of these chemicals, EPA issued two significant new use rules (SNURs). The SNURs require manufacturers, importers, and processors to notify EPA at least 90 days before beginning to use the material. EPA advises potential ‘new users’ to work with EPA to identify the data necessary to satisfy testing requirements.

The SNUR process is cumbersome, and TSCA limits the use parameters that EPA can impose on manufacturers already using materials addressed by SNURs. Regulating the nanomaterials identified by the proposed TSCA data call will also be time-consuming and cumbersome. In addition to conducting the SNUR process to regulate new uses of these materials, EPA may need to reach individual consent orders with manufacturers already using the materials.

EPA has pursued enforcement actions related to nanomaterials against at least two companies for selling unregistered pesticides and making unproven claims about their effectiveness. Last year Kinetic Solutions was fined more than $80,000 for making illegal public health claims about its “Nano Silver Pre filter.” Kinetic Solutions had claimed that the filter could control 650 types of bacteria. The company was also cited for selling unregistered pesticides because the filter was not registered with EPA. ²⁸EPA, Hefty Fine for So Cal Company’s Untested ‘Nano’ Claims, Dec. 15, 2010. See also, S. Siciliano, California Company Fined $82,400 for Claim Of ‘Nano’ Properties in Marketing Air Purifier, BNA’s Daily Environment Report, Dec. 17, 2010 (241 DEN A-13, 12/17/10).

In 2008, IOGEAR was fined more than $200,000 for claiming that coatings on keyboard and mouse accessories would eliminate pathogens and kill bacteria. None of these accessories were registered as a pesticide. ²⁹EPA, U.S. EPA Fines Southern California Technology Company $208,000 for “Nano Coating” Pesticide Claims on Computer Peripherals, March 5, 2008. See also, C. Whetzel, EPA Fines California Firm $208,000 Over Antimicrobial Claims for Nano-Coatings, BNA’s Chemical Regulation Reporter, March 10, 2008 (32 CRR 243, 3/10/08).

Nearly four years after the FDA’s Nanotechnology Task Force recommended that the FDA provide guidance to manufacturers for product applications containing nanomaterials, the FDA has finally released draft guidance. ³⁰FDA, Draft Guidance for Industry; Concerning Whether an FDA-Regulated Product Involves the Application of Nanotechnology (2011). However, the guidance is extremely general. It announced only that “As a first step toward developing FDA’s framework for considering whether FDA-regulated products include nanomaterials or otherwise involve nanotechnology, the agency has developed the points discussed below.” The two points listed in the guidance essentially involve whether a product is of nanoscale dimension and whether the product has a chemical or biological effect attributable to its nanoscale dimension. ³¹Supra note 23. Although the guidance is intended to identify when industry “should consider potential implications for regulatory status, safety, effectiveness, or public health impact,” ³²Id. it provides no information on how the presence of nanomaterials might affect regulatory requirements for drugs or consumer products.

Much health and safety data is required for drugs, but little is required for consumer products, some of which make nano claims. FDA authority is limited with regard to cosmetics, food additives, and dietary supplements. Only when cosmetics are “adulterated” can the FDA take enforcement action against manufacturers. Whether a cosmetic is adulterated is not readily apparent. An adulterated product is one that, when used in compliance with labeling, harms users. However, FDA regulations require cosmetics companies to substantiate the safety of their products. “Failure to adequately substantiate the safety of a cosmetic product or its ingredients prior to marketing causes the product to be misbranded unless the [prescribed] warning statement appears conspicuously on the principal display panel of the product’s label.” The Nanotechnology Task Force recommended that FDA issue “a notice in the Federal Register requesting submission of data and other information addressing the effects on product safety of nanoscale materials in products not subject to premarket authorization.” ³³Id. The Task Force also advised issuing guidance identifying when the presence of nanomaterials would make cosmetics adulterated—that is, harmful to users. The FDA has not indicated whether it will act on these recommendations.

Regulations establishing safety standards for food additives and food ingredients “generally recognized as safe” are regularly issued by the FDA. ³⁴See 21 CFR 170, 172, 173, 180. Manufacturers must petition FDA for premarket approval to use new additives. For new additives containing nanomaterials, manufacturers could be required to submit nano-specific health and safety data. Manufacturers may already be using versions of approved additives that contain nanomaterials. The FDA can issue a data call for information on these products. The agency can also amend current regulations to provide categorical exclusions for the use of nanomaterials. The Nanotechnology Task Force recommended both these actions. ³⁵Supra note 23. Issuing a data call has not been addressed in FDA’s semiannual regulatory agenda.

FDA is also limited in its authority to regulate the safety and labeling of dietary supplements. FDA receives premarket safety information when a company manufactures a dietary supplement containing a “new dietary ingredient.” However, there are no regulations on the nature of the safety information required, nor must a manufacturer wait for approval from FDA before marketing a product containing this ingredient. Furthermore, as with additives, manufacturers may be reformulating their products with nanomaterials without considering the nanomaterials “new dietary ingredients.” FDA is authorized to take enforcement action against “adulterated” products, but for the presence of nanomaterials to constitute adulteration, FDA would need to issue new guidance. Under its existing authority, FDA could also issue guidance specifying the types of health and safety data required in premarket submissions. These actions were also recommended by the Nanotechnology Task Force. As noted above, since the release of the Nanotechnology Task Force Report, FDA has only just begun to develop its framework for regulating nanomaterials; no data calls have been issued.

The CPSC has jurisdiction over most consumer products used in and around the home. CPSC has stated that the potential safety and health risks of nanomaterials can be assessed under CPSC’s existing statutory authority. Neither the Consumer Product Safety Act nor the Federal Hazardous Substances Act—two statutes implemented by CPSC—require premarket product registration. The statutes do require that manufacturers, retailers, and distributors notify CPSC immediately if they “obtain information that reasonably supports the conclusion” that the product creates an unreasonable risk of serious injury or death. In addition, CPSC staff do evaluate consumer products to determine whether products contain “defects” that create a “substantial product hazard” or an “unreasonable risk.” CPSC notes that data identifying the specific types of nanomaterials in consumer products and on the nanomaterials to which the consumer might be exposed are needed to assess health risks. The commission is working with other federal agencies and with private initiatives to study the production and use of nanomaterials. ³⁶CPSC Nanomaterial Statement available at http://www.cpsc.gov/library/cpscnanostatement.pdf.

Environmental and consumer groups have lobbied EPA, FDA, and Congress to accelerate regulatory efforts. The International Center for Technology Assessment (ICTA) has petitioned EPA to regulate all nanosilver ³⁷Petition available at http://www.icta.org/nanoaction/doc/CTA_nano-silver%20petition__final_5_1_08.pdf. and all nanocopper ³⁸Petition available at http://www.beyondpesticides.org/documents/ICTA%20Nano%20Copper%20Petition%20-%20Final.pdf. products as new pesticides. EPA has been fairly responsive to these efforts. ICTA has also petitioned FDA to regulate nano zinc oxide and nano titanium dioxide as new drugs. ³⁹Petition available at http://www.icta.org/doc/Nano%20FDA%20petition%20final.pdf. (See below.)

III. The Nano Risk Framework

The Environmental Defense Fund and DuPont collaborated in 2007 on the development of a “Nano Risk Framework.” The framework is described as a systematic and disciplined process to evaluate and address the potential risks of nanoscale materials. It is a comprehensive guide to assessment of potential environment, health, and safety risks in all stages of a product’s lifecycle, from materials manufacture to product fabrication and packaging to waste management. The framework identifies the basic types of hazard data necessary to identify whether rigorous testing is warranted. ⁴⁰Nano Risk Framework (2007) available at http://nanoriskframework.com/page.cfm?tagID=1095.

The framework relies on “base sets” of information that have been applied in other programs that promote or require hazard-data development. It specifies that base sets represent those test results and other types of data that are deemed by experts to be the minimum needed to prioritize chemicals for more detailed risk assessment. The framework says base sets should contain physical and chemical properties data, health hazard data, and environmental hazard data. Base sets for the framework demonstration projects were developed using characterization principles from the International Life Sciences Institute and the National Cancer Institute’s Nanotechnology Characterization Laboratory, the OECD Screening Information Data Set, National Institute for Occupational Safety and Health nanomaterials guidance, and TSCA reporting requirements for industrial chemicals. ⁴¹Id. EPA’s Office of Chemical Safety and Pollution Prevention currently has no “harmonized test guidelines” explicitly applicable for nanomaterials. EPA has acknowledged that the lack of consistent protocols impedes assessment of toxicological findings. ⁴²EPA, Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray (2010).

The framework developers note that no empirical data are available for many nanomaterials. Thus, they explain, it is necessary to use “reasonable worst-case assumptions” for decisionmaking. Although these assumptions will be based on similar materials, the properties of nanomaterials are very often far different than analogous bulk materials. The framework stresses that informed risk decisions may require further testing beyond the base set, not because information indicates cause for greater concern about potential risk, but because of uncertainty about material characteristics and high inherent hazard potential. The framework recommends the use of “bridging” information that is to inform decisions about needs for more extensive risk assessments by extrapolating from hazard data for similar materials for similar ‘endpoints,’ such as pulmonary toxicity. However, the FIFRA Scientific Advisory Panel cautions against bridging among materials with different properties. The Scientific Advisory Panel notes that the science is still evolving on how material properties affect hazard profiles. ⁴³EPA, Meeting Minutes of the FIFRA Scientific Advisory Panel Meeting on the Evaluation of Hazard and Exposure Associated with Nanosilver and Other Nanometal Pesticide Products (2010).

The framework endorses the creation of consortia to leverage resources for toxicological, environmental fate, and other risk assessment testing. It says development of validated in vitro and in vivo testing methodologies are very much needed. Standardized risk assessment protocols would help industry develop consistent and comprehensive risk characterizations. As the framework report notes, scientifically sound methodologies for understanding the fate and transport of nanomaterials in the body, and for understanding long-term environmental toxicity, biological fate, and behavior, would help industry address the technical challenges of quantifying the risks nanomaterials pose to workers and consumers. ⁴⁴Supra at note 40.

EPA guidance materials also provide useful recommendations for processes to evaluate and address the potential risks of nanoscale materials. For example, the FIFRA Scientific Advisory Panel recommends ISO TC 229 WG3/PG5 for guidance on appropriate material characterization, and ISO/AWI TR 13014 for guidance on toxicological assessment. It also recommends applying the framework of the Minimum Information for Nanomaterial Characterization Initiative. ⁴⁵Supra note 43.

IV. State and European Regulatory Efforts

State and international regulation of nanomaterials may complicate industry compliance efforts. States are frustrated by the pace of federal regulation. The California Legislature mandated a green chemistry program in 2008 “to adopt regulations for identifying and prioritizing chemicals of concern in consumer products and for evaluating safer alternatives to toxic chemicals through a science-based approach.” ⁴⁶California Green Chemistry Initiative: Frequently Asked Questions available at http://www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/upload/FAQs_greenchem.pdf. State regulators have expressed concern that they lack adequate information on the human health and environmental effects of nanomaterials. To better understand their behavior, fate and transport, beginning in December 2010, the state has issued data calls on nanosilver, nano zero-valent iron, nano titanium dioxide, nano zinc oxide, nano cerium oxide, and quantum dots. Massachusetts has issued guidance on ‘good practices’ for enhancing worker safety. ⁴⁷OTA Technology Guidance Document: Nanotechnol-
ogy—Considerations for Safe Development available at http://www.mass.gov/Eoeea/docs/eea/ota/tech_reports/ota_nanotech_guidance.pdf. Elected officials in Pennsylvania, Maine, Wisconsin, South Carolina, and Washington have proposed nanomaterials registries, treating nanomaterials as contaminants of concern, and generally studying health and environmental risks to assess whether state regulation is needed.

The European Parliament is considering changes to chemical controls that would regulate nanomaterials as distinct substances. ⁴⁸See e.g., I. Eisenberger et al., Nano Regulation in the European Union, Nano Trust Dossiers, 17 (2010). To facilitate this, the European Commission is developing a comprehensive science-based definition of nanomaterials for regulatory purposes. ⁴⁹See e.g., Current Developments/Activities on the Safety of Manufactured Nanomaterials
,
No. 29 Series on the Safety of Manufactured Nanomaterials (2011). The commission has funded projects to identify information and appropriate test methods for describing the intrinsic properties of nanomaterials; conduct hazard and risk characterization; assess exposure; and conduct safety evaluation and risk management. ⁵⁰See, e.g., REACH Implementation Plans on Nanomaterials, available at http://www.nanotechia.org/content/activities2/current-projects/niaprojectripons/. In addition, the European Chemicals Agency is assessing the extent to which industry has documented information about nanomaterials in chemical registrations. ⁵¹ECHA, The Operation of REACH and CLP (2011).

The European Union regulates nanomaterials under existing REACH, CLP (classification, labeling and packaging of chemical substances), and plant protection and biocidal products directives. ECHA is developing an inventory of nanomaterials in REACH registrations and CLP notifications. To date applications for registration of only 17 substances have been submitted to REACH (3) and CLP (14). In addition, a small number of substances (fewer than 10) include the term “nano” in a text field of their REACH dossiers. ⁵²B. Quinn, Nanomaterials in REACH Registrations & CLP Notifications: Compilation of an Inventory, presented at Joint JRC nano Event and 2nd ENPRA Stakeholders Workshop, May 10-11, 2011.

REACH requires chemical registration only for substances manufactured or imported in quantities of more than one ton annually, although not until more than 10 tons are produced annually is a chemical safety report required. However, the European Commission requires registration updates for nanomaterials previously registered in their bulk form. If the commission determines that a substance poses an unacceptable health and environmental risk, it will restrict the use of the product.

CLP is intended to supplement REACH. Under CLP labels must identify hazardous substances and inform users about potential hazards. ⁵³Supra note 48. This includes manufacturers, importers, and downstream users, who must classify these substances or mixtures before placing them on the market. Labeling requirements are independent of the actual tonnage manufactured, imported or placed on the market. ⁵⁴ECHA Questions & Answers on
Regulation (EC) No 1272/2008 on
classification, labe
ling and packaging of substances and mixtures available at http://echa.europa.eu/doc/classification/questions_and_answers_clp_20090526.pdf. In addition, manufacturers and importers who learn that their products pose “new” hazards must make this information public. Specifically, they must notify ECHA of updated classification and labeling, publicize the information up and down the supply chain, and update product labels and safety data sheets. ⁵⁵ECHA, New Hazard Information available at http://echa.europa.eu/clp/classification/new_hazard_information_en.asp. The fact that a product has been reformulated to include nanomaterials could be considered new information that must be made public. ⁵⁶Supra note 48. Similarly, if plant protection products (i.e., pesticides) are reformulated to include nanomaterials, it is likely that the product would be considered one containing a new active substance. Such products are subject to registration under Regulation (EC) 1107/2009. Biocidal products are also subject to new active substances registration requirements. ⁵⁷Id.

The European Commission also regulates the use of nanomaterials in cosmetics and “foodstuffs.” Product safety regulations stipulate that nanomaterials may only be used in cosmetics if they are safe and that the nanoscale ingredients be included on the list of ingredients. In addition, manufacturers must notify the commission about these products. ⁵⁸Directive EC 1223/2009. The EC Directorate General for Health commissioned a study, released in 2007, on the safety of nanomaterials in cosmetic products. The authors expressed concerns about both the potential for harmful effects (e.g., oxidative stress, toxicity) from the use of cosmetics containing nanomaterials and the lack of research on hazard identification, exposure assessment, mechanisms for absorption and transport across membranes in the stomach, intestines, lungs, and in secondary organs. ⁵⁹DG Health and Consumers, Scientific Opinion on the Safety of Nanomaterials in Cosmetic Products (2007).

Food additives reformulated to include nanomaterials are considered new additives. Regulation EC 1333/2008 requires that the European Food Safety Authority assess health risks before new additives may be placed on the market. ⁶⁰See, e.g., http://europa.eu/legislation_summaries/consumers/product_labelling_and_packaging/sa0003_en.htm. The authority has published guidance on risk assessment of nanomaterials in food. The guidance discusses risk assessments for food additives, enzymes, flavorings, food contact materials, and novel foods. ⁶¹EFSA, Guidance on the Risk Assessment of the Application of Nanoscience and Nanotechnologies in the Food and Feed Chain (2011).

In June the European Parliament agreed new EU food labeling rules that include a requirement for all ingredients in the form of engineered nanomaterials to be clearly indicated in the list of ingredients. The rules, which will apply three years after the formal adoption of the legislation by the European Commission and EU member states and its appearance in the EU Official Journal, include a definition of nanomaterials.

V. The Business of Nanotechnology

The business community sees great promise in the potential of nanotechnologies. The NanoBusiness Commercialization Association (NanoBCA) expects trillions of dollars of nano-enabled products to enter the marketplace. The NanoBCA and other trade groups, such as the Nanotechnologies Industries Association and the Nanotechnology Coalition, advocate for innovation and commercialization of the next generation of technologies. Some trade groups focus efforts on lobbying Congress for funding for the National Nanotechnology Initiative to help commercialize nanomaterials.

The business community has also expressed concerns that federal regulatory efforts might create a bias against nanotechnology. For example, commenting on EPA’s proposal to assess the risks of nanomaterials in pesticide products, an American Chemistry Council (ACC) representative asserted that EPA “is creating the false impression that there are always adverse effects from using nanotechnology in pesticides.” ⁶²D. Fears, Federal Agencies to Study Guidelines on Nanomaterials, Washington Post, June 9, 2011. ACC also expressed concern that the Nano Risk Framework (see above) “may appear overly burdensome, such that innovators and related decision makers … may be discouraged by the potential burden of conducting all the steps in the Framework and the subsequent costs of doing so.” ⁶³Feedback from ACC, available at http://nanoriskframework.org/content.cfm?contentID=6382. The NanoBusiness Alliance has asked Rep. Darrell Issa (R-Calif.), chairman of the House Oversight and Government Reform Committee, to look into EPA’s regulatory efforts. The alliance asserts that EPA regulatory efforts “may adversely impact the nanotechnology industry through direct regulatory compliance costs, or more dangerously, by raising unnecessary public alarms through unfounded and inconsistent characterizations of nanotechnology materials.”
⁶⁴NanoBusiness Alliance, Response to December 29, 2010, Letter to Trade Associations available at http://newhavenindependent.org/archives/upload/2011/02/nanobizletter.pdf. However, a robust federal regulatory framework would preempt state regulatory efforts—efforts that are likely to produce conflicting restrictions that would hamper industry’s ability to bring products to market.

VI. Public Health Concerns

Nongovernmental organizations also are concerned about the slow pace of federal regulatory efforts. One advocate for increased regulatory efforts argues, “A little regulation could go a long way toward restoring confidence in our ability to produce and use these emerging materials in a manner that reaps the benefits and avoids the harms they may otherwise cause.” ⁶⁵R. Denison, Regulating Nanomaterials to Life, not Death, blog post Jan. 28, 2011 available at http://blogs.edf.org/nanotechnology/2011/01/28/regulating-nanomaterials-to-life-not-death/.

As noted above, impatient with the pace of regulation to address nanomaterials’ potential for health and environmental harms, the International Center for Technology Assessment (ICTA) has petitioned for controls over nanosilver, ⁶⁶Supra note 37. nanocopper, ⁶⁷Supra note 38. nano zinc oxide, and nano titanium. ⁶⁸Supra note 39.

ICTA petitioned the FDA to “amend regulations for products composed of engineered nanoparticles” in May 2006. There has been no official response to the petition. The petition argues that the inclusion of nanomaterials in sunscreen products makes the products new drugs rather than over-the-counter sunscreen drug products. Over-the-counter products must comply with general regulations. New drugs are subject to rigorous new drug applications. ⁶⁹Id. FDA did issue new sunscreen regulations related to labeling and effectiveness testing on June 17. Neither the Federal Register notice nor the regulations use the words “nanomaterials,” “nanoparticles,” or “nanotechnology.” The notice explains, “[t]he document does not address issues related to sunscreen active ingredients or certain other issues regarding the GRASE determination for sunscreen products.” ⁷⁰76 Fed. Reg. 35,620. FDA does promise further evaluation the GRASE status of sunscreen active ingredients.

ICTA’s FDA petition also asserts that sunscreen products containing engineered nanoparticles of zinc oxide and titanium dioxide pose an imminent hazard to public health. The European Commission’s report on the safety of nanomaterials in cosmetic products did consider the risks of nano zinc oxide and nano titanium dioxide explicitly. Nano titanium dioxide was found safe by a European science panel for use in cosmetic products in 2000. ⁷¹Opinion of the Scientific Committee on Cosmetic Products and Non-Food Products Intended for Consumers Concerning Titanium Dioxide, available at http://ec.europa.eu/health/archive/ph_risk/committees/sccp/documents/out135_en.pdf. However, the authors note that it would be prudent to review new scientific data on the material and to evaluate the safety of the material when applied to unhealthy skin. Furthermore, the authors were unable to formulate an opinion on the safety of zinc oxide. They noted that the dossier contained insufficient data to enable them to form an opinion. ⁷²Supra note 59. The report voices no concerns that the products pose an imminent hazard to public health.

EPA published an assessment of nanosilver in disinfectant sprays in 2010 ⁷³Supra note 42. and an evaluation of nanometals in pesticides in 2009. ⁷⁴EPA, Evaluation of the Hazard and Exposure Associated with Nanosilver and Other Nanometal Pesticide Products (2009). These reports, and findings from a likely data call on nanomaterials in pesticides products, ⁷⁵Supra note 26. will help EPA address the May 2008 ICTA nanosilver petition. However, both EPA reports point to data gaps that impede decisionmaking. For example, the FIFRA Scientific Advisory Panel noted that existing environmental fate models will not accurately predict nanosilver exposure scenarios. The panel also advised against extrapolating hazard findings from one nanosilver formulation to another. ⁷⁶Supra note 43. The case study said nanosilver has the potential to disrupt the nutrient cycling processes of soil microorganisms. It also stressed that “the factors and conditions that most influence nano[silver] toxicity have not yet been determined.” ⁷⁷Supra note 44. EPA has accepted public comment on the petition. ⁷⁸See docket EPA-HQ-OPP-2008-650 at http://www.regulations.gov.

ICTA petitioned for nanocopper products to be registered as pesticides in November 2010. EPA has not yet announced whether it will review or solicit comment on the petition.

VII. Looking Forward

The tension between the need to test and understand the potential risks and hazards of nanomaterials and the desire to commercialize the materials is likely to continue. Companies large and small see great potential for innovation and profit. Environmental and public health groups worry that precautionary measures are inadequate. Friends of the Earth points to “public and environmental health disasters that could have been avoided if greater attention had been paid to early warning signs of danger, including asbestos, benzene, PCBs and BSE (mad cow disease).” ⁷⁹FOE http://nano.foe.org.au/node/186. Scientists echo this caution. ⁸⁰See e.g., Supra note 16. The future will tell the extent to which industry supports responsible development of commercial nanotechnology applications.