Nanotechnology Lawyer & Attorney : Bergeson & Campbell Law Firm : Nanotechnology Law Blog

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.

OPP’s working definition of nanomaterial is:

An ingredient that contains particles that have been intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers.

Although nanomaterials occur naturally and can be produced unintentionally, Jordan noted that OPP’s working definition includes the phrase “intentionally produced,” and that those are the ones OPP intends to address.

To obtain more data on hazard and exposure from nanosilver and other nanometal pesticide products, OPP is in the process of preparing a Federal Register notice on nanomaterials and pesticide products. The notice will announce a new interpretation of regulations under Section 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and propose a new policy in June 2010. The new interpretation will be that the presence of a nanoscale material is reportable under FIFRA Section 6(a)(2). 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.

Jordan also announced that OPP intends to respond in June 2010 to the International Center for Technology Assessment’s (ICTA) May 2008 petition. In its petition, ICTA urged EPA to regulate nanosilver products as pesticides, and asked EPA to take action on an estimated 600 unregistered nanosilver products marketed in the U.S.

Jordan noted the following activities in other EPA offices:

• Office of Research and Development (ORD) developing a Draft Case Study on nanosilver (expected in 2010); and
• Office of Pollution Prevention and Toxics (OPPT) developing the following rules under the Toxic Substances Control Act (TSCA):
• Significant New Use Rule (SNUR) -- Intended to address nanoforms of existing chemicals;
• Section 8(a) Rule -- Would obtain existing data on current nanomaterials; and
• Section 4 Test Rule -- Likely at the end of 2010.

The proposed rule provides the following basis for action:

The PMN states that the substance will be used as an additive/filler for polymer composites and support media for industrial catalysts. Based on test data on analogous respirable, poorly soluble particulates and on other carbon nanotubes (CNTs), EPA identified concerns for lung effects, immunotoxicity, and mutagenicity from exposure to the PMN substance. For the uses described in the PMN, worker inhalation and dermal exposures are minimal due to the use of adequate personal protective equipment. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance without the use of gloves and protective clothing, where there is a potential for dermal exposure; use of the substance without a National Institute for Occupational Safety and Health (NIOSH)-approved full-face respirator with an N100 cartridge, where there is a potential for inhalation exposure; or use other than as described in the PMN, may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at 721.170(b)(3)(ii).

The proposed SNUR would apply only to the multi-walled carbon nanotubes described in premanufacture notice (PMN) P08-199. According to EPA, in the past, some stakeholders have asked whether these types of SNURs apply to all variants of carbon nanotubes. EPA states: “This is not the case.” The chemical name listed in the proposed SNUR is “multi-walled carbon nanotubes (generic),” and the CAS Number is “not available.” On November 6, 2009, EPA published a proposed SNUR for the multi-walled carbon nanotubes described in PMN P08-177.