OMB Receives EPA Notice Concerning Pesticide Products Containing Nanoscale Materials

Posted on August 4, 2010 by Lynn L. Bergeson

According to the Office of Management and Budget (OMB) website, on July 30, 2010, OMB received from the U.S. Environmental Protection Agency (EPA) a notice concerning “Pesticide Products Containing Nanoscale Materials.” No additional information regarding the notice is available on OMB’s website. During the April 29, 2010, meeting of EPA’s Pesticide Program Dialogue Committee (PPDC), William Jordan, Senior Policy Advisor, Office of Pesticide Programs (OPP), stated that EPA was in the process of preparing a Federal Register notice on nanomaterials and pesticide products. The notice will announce a new interpretation of Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(a)(2) regulations, that the presence of a nanoscale material is reportable under FIFRA Section 6(a)(2). This controversial interpretation would apply to already registered products, as well as products pending registration. In the same notice, EPA is expected also to memorialize OPP’s view that an active or inert ingredient would be considered “new” if it is a nanoscale material. The new policy would apply even when a non-nanoscale form of that same active or inert is already in a FIFRA-registered product. On June 25, 2010, the U.S. Government Accountability Office (GAO) issued a report entitled Nanotechnology: Nanomaterials Are Widely Used in Commerce, but EPA Faces Challenges in Regulating Risk, which recommends, among other actions, that 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. EPA responded that it agreed with GAO’s recommendation and is working on clarification of registrant’s responsibilities under FIFRA with respect to nanomaterials.

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GAO Report States That EPA Faces Challenges in Regulating Risk of Nanomaterials

Posted on June 28, 2010 by Lynn L. Bergeson

According to a report released on June 25, 2010, by the U.S. Government Accountability Office (GAO), the U.S. Environmental Protection Agency (EPA) faces challenges in effectively regulating nanomaterials that may be released in air, water, and waste because EPA 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. In preparing its report, GAO identified examples of current and potential uses of nanomaterials; determined what is known about the potential human health and environmental risks from nanomaterials; assessed actions EPA has taken to better understand and regulate the risks posed by nanomaterials as well as its authorities to do so; and 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.

GAO’s report includes the following recommendations, all of which are “in process.” EPA’s responses are from its May 4, 2010, letter responding to GAO’s recommendations. The letter is included in GAO’s report.

  • The Administrator of EPA should complete its plan to issue a significant new use rule (SNUR) for nanomaterials.

EPA response: EPA agrees. EPA will continue to issue SNURs for nanoscale materials that are new chemical substances on a case-by-case basis, as appropriate, and intends to propose a SNUR for nanoscale materials that are existing chemical substances by December 2010.

  • 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.

EPA response: EPA agrees and intends to clarify that, as part of the application for registration, applicants for pesticide registrations which contain nanomaterial ingredients need to specifically identify those ingredients.

  • 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.

EPA response: EPA agrees and is working on clarification of registrant’s responsibilities under FIFRA with respect to nanomaterials.

  • 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 the Toxic Substances Control Act (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.

EPA response: EPA agrees and intends to propose a Section 8(a) information-gathering rule as described in the recommendation and also intends to propose a Section 4 test rule.

  • 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 (CWA) to collect information about potential discharges containing nanomaterials.

EPA response: EPA agrees that collecting information about discharges is a critical component of understanding potential environmental risks. EPA’s Office of Research and Development, and others, is conducting research to determine whether nanomaterials may enter the water in forms and levels of concern, as well as how to detect and monitor nanomaterials in effluents and aquatic systems. Once we have these capabilities, EPA will consider whether new reporting requirements should be applied to companies who may be discharging nanomaterials into the environment, including under the CWA.

  • The Administrator of EPA should consider revising the Inventory Update Rule (IUR) under 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 response: EPA agrees and will consider proposing periodic reporting under the IUR for nanoscale materials.

 
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GAO Testifies Before Senate Subcommittee on the Accuracy of Data Concerning Federally Funded EHS Research

Posted on April 29, 2008 by Lynn L. Bergeson
On April 24, 2008, the U.S. Government Accountability Office (GAO) released a report entitled Nanotechnology: Accuracy of Data on Federally Funded Environmental, Health, and Safety Research Could Be Improved, which contains the testimony of Robert A. Robinson, Managing Director, Natural Resources and Environment, before the Senate Committee on Commerce, Science, and Transportation Subcommittee on Science, Technology, and Innovation. Robinson provided a summary of GAO’s findings as reported in its March 31, 2008, report entitled Nanotechnology: Better Guidance Is Needed to Ensure Accurate Reporting of Federal Research Focused on Environmental, Health, and Safety Risks. GAO was asked to focus on: (1) the extent to which selected agencies conducted environmental, health, and safety (EHS) research in fiscal year (FY) 2006; (2) the reasonableness of the agencies’ and the National Nanotechnology Initiative’s (NNI) processes to identify and prioritize EHS research; and (3) the effectiveness of the agencies’ and the NNI’s process to coordinate EHS research. According to NNI, in FY 2006, federal agencies devoted $37.7 million -- or three percent of the $1.3 billion total nanotechnology research funding -- to research primarily focused on the EHS risks of nanotechnology, according to the NNI. GAO found that about 20 percent of this total could not actually be attributed to this purpose, however. GAO states that 22 of the 119 projects identified as EHS in FY 2006 were not primarily related to understanding the extent to which nanotechnology may pose an EHS risk. Instead, many of the projects focused on how to use nanotechnology to remediate environmental damage or detect hazards not related to nanotechnology. GAO states that, at the time of its review, federal agencies and NNI were in the process of identifying and prioritizing EHS risk research needs, and the overall process they were using appeared reasonable. NNI also was engaged in an iterative prioritization effort through its Nanotechnology Environmental and Health Implications (NEHI) working group. NEHI identified five general research categories as a priority for federally funded research. GAO found that most of the research projects that were underway in FY 2006 were generally consistent with agency and NEHI priorities. NEHI released its new EHS research strategy on February 13, 2008. According to GAO, agency and NNI processes to coordinate activities related to potential EHS risks of nanotechnology have been generally effective. In its March 2008 report, GAO recommended better guidance to improve the accuracy of data reported by NNI. Although the Office of Science and Technology Policy (OSTP) asserted that it provides extensive guidance, it agreed to review how the agencies respond to the current guidance. Robinson made no new recommendations in his statement before the Subcommittee.
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