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

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.

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.

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 manufacture; processing, use, exposure, and release information; and available health and safety data. The rule involves one-time reporting for existing discrete forms of certain nanoscale materials, and a standing one-time requirement for new discrete forms of certain nanoscale materials before those new forms are manufactured or processed.

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).