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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Highlights
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.
Recommendations
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| Environmental Protection Agency | The Administrator of EPA should complete its plan to issue a Significant New Use rule for nanomaterials. | According to EPA, the agency developed a proposed Significant New Use Rule (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. As of March 2016, EPA has taken no further action to advance a SNUR. The original proposed rule was merged with one related to reporting of nanomaterials and EPA has not taken any further action with regard to introducing a new SNUR for nanomaterials. As of May 2016, EPA has taken no further action to advance the SNUR to request additional information on nanomaterials. According to agency officials, EPA is focusing instead on a TSCA section 8(a) proposed rule for reporting nanomaterials, which was scheduled to be published by December 2016.
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| Environmental Protection Agency | 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. | 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...
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| Environmental Protection Agency | 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. | 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...
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| Environmental Protection Agency | 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. | In January 2017, EPA published a final rule regarding the reporting and recordkeeping requirements on nanoscale chemical substances in the marketplace. EPA currently reviews new chemical substances manufactured or processed as nanomaterials prior to introduction into the marketplace. This rule, issued under the authority of section 8(a) under the Toxic Substances Control Act, will allow EPA to collect existing exposure and health and safety information on chemicals currently in the marketplace when manufactured or processed as nanoscale materials. The companies will be required to notify EPA of certain information, including specific chemical identify; production volume; methods of...
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| Environmental Protection Agency | 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. | 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...
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| Environmental Protection Agency | 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. | 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. As of March 2016, no further action has been taken by EPA with regard to advancing the CDR, and there is no indication that EPA is considering another update to this. According to agency officials, as of May 2016,...
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