Nanotechnology:

Nanomaterials Are Widely Used in Commerce, but EPA Faces Challenges in Regulating Risk

GAO-10-549: Published: May 25, 2010. Publicly Released: Jun 24, 2010.

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Nanotechnology involves the ability to control matter at the scale of a nanometer--one billionth of a meter. The world market for products that contain nanomaterials is expected to reach $2.6 trillion by 2015. In this context, GAO (1) identified examples of current and potential uses of nanomaterials, (2) determined what is known about the potential human health and environmental risks from nanomaterials, (3) assessed actions EPA has taken to better understand and regulate the risks posed by nanomaterials as well as its authorities to do so, and (4) identified approaches that other selected national authorities and actions U.S. states have taken to address the potential risks associated with nanomaterials. GAO analyzed selected laws and regulations, reviewed information on EPA's Nanoscale Materials Stewardship Program, and consulted with EPA officials and legal experts to obtain their perspectives on EPA's authorities to regulate nanomaterials.

Companies around the world are currently harnessing the properties of nanomaterials for use in products across a number of sectors and are expected to continue to find new uses for these materials. GAO identified a variety of products that currently incorporate nanomaterials already available in commerce across the following eight sectors: automotive; defense and aerospace; electronics and computers; energy and environment; food and agriculture; housing and construction; medical and pharmaceutical; and personal care, cosmetics and other consumer products. Within each of these sectors, GAO also identified a wide variety of other uses that are currently under development and are expected to be available in the future. The extent to which nanomaterials present a risk to human health and the environment depends on a combination of the toxicity of specific nanomaterials and the route and level of exposure to these materials. Although the body of research related to nanomaterials is growing, the current understanding of the risks posed by these materials is limited. This is because the manner in which some studies have been conducted does not allow for valid comparisons with newer studies or because there has been a greater focus on certain nanomaterials and not others. Moreover, the ability to conduct necessary research on the toxicity and risks of nanomaterials may be further hampered by the lack of tools to conduct such studies and the lack of models to predict the characteristics of nanomaterials. EPA has undertaken a multipronged approach to understanding and regulating the risks of nanomaterials, including conducting research and implementing a voluntary data collection program. Furthermore, under its existing statutory framework, EPA has regulated some nanomaterials but not others. Although EPA is planning to issue additional regulations later this year, these changes have not yet gone into effect and products may be entering the market without EPA review of all available information on their potential risk. Moreover, EPA faces challenges in effectively regulating nanomaterials that may be released in air, water, and waste because it lacks the technology to monitor and characterize these materials or the statutes include volume based regulatory thresholds that may be too high for effectively regulating the production and disposal of nanomaterials. Like the United States, Australia, Canada, the United Kingdom, and the European Union have begun collecting data to understand the potential risks associated with nanomaterials and are reviewing their legislative authorities to determine the need for modifications. Australia and the United Kingdom have undertaken a voluntary data collection approach whereas Canada plans to require companies to submit certain types of information. Some U.S. states, like California, have also begun to address the potential risks from nanomaterials by, for example, collecting information from manufacturers on a limited number of nanomaterials in use in those states and making some of this information publicly available.

Recommendations for Executive Action

  1. Status: Open

    Comments: According to EPA, the agency developed a proposed SNUR and submitted it for OMB review on November 19, 2010. OMB forwarded comments from U.S. government review on May 18 and June 13, 2011. EPA sent responses to these comments on May 25, June 21, and July 21, 2011, respectively. As of June 2014, the proposed SNUR and EPA's responses to comments are still being reviewed by OMB and other U.S. Government agencies, according to agency officials. In addition, EPA has finalized and issued two SNURs covering specific types of carbon nanotubes since our report was issued. While these are positive steps with regard to new substances, additional action is required for existing chemicals that had already been registered.

    Recommendation: The Administrator of EPA should complete its plan to issue a Significant New Use rule for nanomaterials.

    Agency Affected: Environmental Protection Agency

  2. Status: Closed - Implemented

    Comments: Since the issuance of GAO's report, EPA has initiated actions to address GAO's recommendations concerning pesticides. While EPA has not modified their guidelines, EPA is utilizing its existing regulations as a framework to collect the information necessary to identify and assess the presence of nanoscale ingredients in products for which registration is being sought, according to agency officials. Specifically, EPA issued a notice proposing to use its existing authorities to clarify reporting of nanoscale ingredients in existing and new pesticide products. The notice, which appeared in the Federal Register on June 17, 2011 (76 Fed. Reg. 35383), proposed an approach for how EPA will determine on a case-by-case basis whether a nanoscale ingredient is a "new" active or inert ingredient for purposes of scientific evaluation under the pesticide laws, when a non-nanoscale form of the ingredient is already registered under FIFRA. Rather than move ahead with a final notice, EPA is instead utilizing its existing regulations as a framework to collect the information necessary to identify and assess the presence of nanoscale ingredients in products for which registration is being sought, according to agency officials. With respect to products being proposed for new registration, EPA is working to identify pesticides that contain nanoscale ingredients and is meeting with applicants to discuss data requirements prior to application. Specifically, according to agency officials, EPA ensures that the application provides sufficient information for EPA to make the determination of whether the product contains a nanoscale ingredient. Further, according to officials, EPA has been closely following the public literature on research and development of nanoscale ingredients. Based on this knowledge, EPA's guidance focuses on specific substances, such as silver and certain other metals, for which technology providers are developing uses in the nanoscale form. If an applicant seeks to register a product containing one of these materials, EPA is requiring the applicant to provide information adequate to determine whether or not the material in the pesticide formulation is in the nanoscale, according to agency officials.

    Recommendation: The Administrator of EPA should modify Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) pesticide registration guidelines to require applicants to identify nanomaterial ingredients in pesticides.

    Agency Affected: Environmental Protection Agency

  3. Status: Closed - Implemented

    Comments: Since the issuance of GAO's report, EPA has initiated actions to address GAO's recommendations concerning pesticides containing nanoscale ingredients. While EPA has not specifically made a statement that all nanoscale ingredients are considered to be new ingredients, it has used its data call-in authority to collect info on all already registered silver-based products. Specifically, EPA issued a notice proposing to use its existing authorities to clarify reporting of nanoscale ingredients in existing and new pesticide products. The notice, which appeared in the Federal Register on June 17, 2011 (76 Fed. Reg. 35383), requested public comments through August 17, 2011, on approaches for gathering information on nanoscale ingredients in currently registered pesticide products. The notice also proposed an approach for how EPA will determine on a case-by-case basis whether a nanoscale ingredient is a "new" active or inert ingredient for purposes of scientific evaluation under the pesticide laws, when a non-nanoscale form of the ingredient is already registered under FIFRA. Rather than move ahead with a final notice, EPA is instead utilizing its existing regulations as a framework to collect the information necessary to identify and assess the presence of nanoscale ingredients in already registered pesticides, as well as in those products for which registration is being sought, according to agency officials. For existing registrations, EPA is using its registration review program as part of its effort to identify products that contain a nanoscale ingredient. Specifically, FIFRA section 3(c)(2)(B) authorizes EPA to issue orders, referred to as Data Call-Ins (DCIs), to registrants requiring them to submit data necessary to support the continued registrations of their products. For example, in February 2012, EPA issued a DCI notice to all registrants with silver-based products requiring registrants to provide measurements, among other data, of the particle size and particle size distribution of silver-containing compounds in their products. These data are intended to help EPA to identify currently registered products that may contain nanoscale silver, according to agency officials. Products determined to contain nanosilver will be included in the nanosilver registration review case and will be evaluated separately from other silver-based pesticides. With respect to products being proposed for new registration, EPA is working to identify pesticides that contain nanoscale ingredients and is meeting with applicants to discuss data requirements prior to application. Specifically, according to agency officials, EPA ensures that the application provides sufficient information for EPA to make the determination of whether the product contains a nanoscale ingredient. Further, according to officials, EPA has been closely following the public literature on research and development of nanoscale ingredients. Based on this knowledge, EPA's guidance focuses on specific substances, such as silver and certain other metals, for which technology providers are developing uses in the nanoscale form. If an applicant seeks to register a product containing one of these materials, EPA is requiring the applicant to provide information adequate to determine whether or not the material in the pesticide formulation is in the nanoscale, according to agency officials.

    Recommendation: The Administrator of EPA should complete its plan to clarify that nanoscale ingredients in already registered pesticides, as well as in those products for which registration is being sought, are to be reported to EPA and that EPA will consider nanoscale ingredients to be new.

    Agency Affected: Environmental Protection Agency

  4. Status: Open

    Comments: EPA developed a proposed TSCA section 8(a) information reporting rule. The Agency submitted the proposed rule for OMB review on November 19, 2010. OMB forwarded comments from U.S. government review on May 18 and June 13, 2011. EPA sent responses to these comments on May 25, June 21, and July 21, 2011, respectively. As of June 2014, the proposed rule and EPA's responses to comments are still being reviewed by OMB and other U.S. Government agencies. In addition, EPA is also developing a TSCA section 4 test rule for certain nanomaterials that will require the development of new information. As of June 2014, the rule is still under development, according to agency officials.

    Recommendation: The Administrator of EPA should make greater use of the agency's authorities to gather information under existing environmental statutes. Specifically, EPA should complete its plan to use data gathering and testing authorities under TSCA to gather information on nanomaterials, including production volumes, methods of manufacture and processing, exposure and release, as well as available health and safety studies.

    Agency Affected: Environmental Protection Agency

  5. Status: Closed - Implemented

    Comments: EPA still faces limitations in appropriate analytical and monitoring capabilities; however, the agency has taken steps to gather information related to discharges of nanomaterials. Section 308 of the Clean Water Act (CWA ? 308, 33 U.S.C. ? 1318) does allow EPA the authority to collect data, but unique technical challenges exist with regard to nanoparticles. Specifically, the foremost challenge is the inability to currently measure concentrations of nanomaterials in effluent discharges, and thus the absence of monitoring systems, according to agency officials. However, as part of the Office of Water's 2014 Annual Review of industrial wastewater discharges required by the Clean Water Act, the Effluent Guidelines Program is investigating nanomaterials as a potential new source of industrial wastewater pollution. Specifically, EPA is soliciting data and information on the manufacture, use, and environmental release of silver materials, including nanosilver. This investigation has been collecting existing information to assess whether these materials are toxic to aquatic life, if they are found in industrial wastewater from producers or formulators, and if they are being discharged at levels that could be harmful to the environment and human health. The Effluent Guidelines Program will publish its findings to date in its 2014 Annual Review Report anticipated to be published later this year, according to agency officials. In this effort, the Effluent Guidelines Program has been coordinating with the National Nanomaterials Initiative (NNI), university researchers and with EPA's Office of Pollution Prevention and Toxics (OPPT) and the Office of Research and Development (ORD).

    Recommendation: The Administrator of EPA should make greater use of the agency's authorities to gather information under existing environmental statutes. Specifically, EPA should use information-gathering provisions of the Clean Water Act to collect information about potential discharges containing nanomaterials.

    Agency Affected: Environmental Protection Agency

  6. Status: Open

    Comments: EPA published the final TSCA Chemical Data Reporting (CDR) rule on August 16, 2011, which updates IUR reporting requirements. The proposed 8(a) rule (currently undergoing OMB review) specifically asks for public comments on periodic IUR type reporting for nanoscale materials, according to agency officials. Based on public comments received once this proposed rule is issued, EPA will consider changes to future CDR reporting cycles to specifically address nanoscale materials.

    Recommendation: The Administrator of EPA should consider revising the Inventory Update Rule under Toxic Substances Control Act of 1976 (TSCA) so that it will capture information on the production and use of nanomaterials and so that the agency will receive periodic updates on this material.

    Agency Affected: Environmental Protection Agency

 

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