Potassium Titanium Oxide SNUR Bans Manufacture of Particle Size Less Than 100 nm

On October 5, 2012, the U.S. Environmental Protection Agency (EPA) promulgated a final significant new use rule (SNUR) for potassium titanium oxide, which was previously the subject of a consent order under Section 5(e) of the Toxic Substances Control Act (TSCA). EPA states that, based on test data on the premanufacture notice (PMN) substance and structure activity relationship analysis of test data on analogous respirable, poorly soluble particulates (subcategory titanium dioxide), EPA “identified concerns for lung toxicity and fibrosis in workers exposed to the PMN substance by the inhalation route.” EPA issued the consent order based on a finding that the substance may present an unreasonable risk of injury to human health. The conditions required by the consent order include “[n]o manufacture of the PMN substance with a particle size less than 100 nanometers.” The final SNUR designates as a significant new use the absence of the protective measures required by the consent order. According to the SNUR, EPA determined that a 90-day inhalation toxicity test with special attention to histopathology of the lung tissues and to various parameters of the broncoalveolar lavage fluid would help characterize the human health effects of the PMN substance. The SNUR will be effective on December 4, 2012. Written adverse or critical comments, or notice of intent to submit adverse or critical comments, are due November 5, 2012.

EPA Promulgates SNUR for Infused Carbon Nanostructures

On April 4, 2012, the U.S. Environmental Protection Agency (EPA) promulgated, through a direct final rule, significant new use rules (SNUR) for 17 chemical substances that were the subject of premanufacture notices (PMN). This includes a SNUR for “infused carbon nanostructures (generic).” According to EPA, the PMN states that the generic (non-confidential) use of the substance is as an additive to provide conductive properties to reinforcements used in composites. EPA states that, based on available information on analogous chemical substances, the PMN substance may cause lung effects. For the use described in the PMN, however, no significant inhalation exposures are expected, and EPA “has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk.” EPA notes that it has determined, however, that a manufacturing process other than as described in the PMN may cause serious health effects. Based on this information, EPA states the PMN substance meets the concern criteria at 40 C.F.R. Section 721.170(b)(3)(ii). EPA determined that the results of the following information would help characterize the health effects of the PMN substance: the dimensions, characteristics, and physical-chemical properties of the carbon nanostructures. Under the SNUR, these properties should be determined once a year for three consecutive years. The direct final rule is effective on June 4, 2012. Written adverse or critical comments, or notice of intent to submit adverse or critical comments, are due May 4, 2012.

EPA Extends Comment Period for Proposed SNURs

The U.S. Environmental Protection Agency (EPA) has announced that, in response to public comments, it will provide the public more time to comment on the December 28, 2011, proposed significant new use rules (SNUR) for 17 chemical substances that were the subject of premanufacture notices (PMN). Of particular interest, seven of the PMN substances’ reported chemical names include the term “carbon nanotube” (CNT) or “CNT.” EPA states “the comment period is being reopened until 45 days following publication of the new notice (until approximately mid-March).”  Importantly, the docket reveals that requests for extension were submitted by the International Center for Technology Assessment (ICTA), the American Federation of Labor and Congress of Industrial Organizations (AFL-CIO), the United Automobile, Aerospace & Agricultural Implement Workers of America (UAW), and the United Steelworkers Union (USW).  The USW comment specifically asserts that the “specific protection measures required for individual PMN substances indicate that personal protective equipment, including gloves and respirators, should be the first line of defense to protect workers.  These requirements do NOT follow occupational health and safety best practices” (emphasis in original). The comment then goes on to cite the ANSI/AIHA Z10 2005 standard and the Occupational Safety and Health Administration (OSHA) standards as best practices.

This is an important perspective in the ongoing worker protection debate and the requests for comment deadline extension suggest that the unions are likely to become more engaged in this discussion.

 

EPA Publishes Proposed SNURs for CNTs

The U.S. Environmental Protection Agency (EPA) published on December 28, 2011, proposed significant new use rules (SNUR) for 17 chemical substances that were the subject of premanufacture notices (PMN). Of particular interest, seven of the PMN substances’ reported chemical names include the term “carbon nanotube” (CNT) or “CNT.”  EPA states that because of a lack of established nomenclature for CNTs, the Toxic Substances Control Act (TSCA) Inventory names for CNTs are currently in generic form, e.g., “carbon nanotube (CNT), multi-walled carbon nanotube (MWCNT), double-walled carbon nanotube (DWCNT), or single-walled carbon nanotube (SWCNT).” EPA uses the specific structural characteristics provided by the PMN submitter to characterize more specifically the TSCA Inventory listing for an individual CNT. According to EPA, all submitters of new chemical notices for CNTs have claimed those specific structural characteristics as confidential business information (CBI). The proposed rule includes the generic chemical name along with the PMN number to identify that a distinct chemical substance was the subject of the PMN without revealing the confidential chemical identity of the PMN substance. Comments are due January 27, 2012.

EPA notes that, since confidentiality claims preclude a more detailed description of the identity of the CNTs, if an intended manufacturer, importer, or processor of CNTs is unsure of whether its CNTs are subject to the proposed SNURs, the company can either contact EPA or obtain a written determination from EPA pursuant to the bona fide procedures at 40 C.F.R. § 721.11. EPA states that it is using the specific structural characteristics, for all CNTs submitted as new chemical substances under TSCA, to help develop standard nomenclature for placing these chemical substances on the TSCA Inventory. EPA has compiled a generic list of those structural characteristics entitled “Material Characterization of Carbon Nanotubes for Molecular Identity (MI) Determination & Nomenclature.”

EPA Regulatory Agenda Includes Notices Concerning Nanoscale Materials

The U.S. Environmental Protection Agency’s (EPA) July 7, 2011, Regulatory Agenda includes several notices concerning nanoscale materials:

  • Test Rule for Certain Nanoscale Materials -- EPA states that it is developing a test rule under Section 4(a) of the Toxic Substances Control Act (TSCA) to require manufacturers (defined by statute to include importers) and processors of the multiwall carbon nanotube described in Premanufacture Notice (PMN) P-08-199, certain clays (e.g., kaolin (including halloysite) and bentonite (including montmorillonite)), alumina, and spray-applied nanomaterials to conduct testing for health effects, ecological effects, and environmental fate, as well as provide material characterization data. EPA intends to issue a notice of proposed rulemaking (NPRM) in August 2011.
  • Significant New Use Rule (SNUR) -- EPA is developing a SNUR for nanoscale materials under TSCA Section 5(a)(2). The SNUR would require persons who intend to manufacture, import, or process this/these chemical substance(s) for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. In addition, according to the notice, EPA is developing a proposal to require reporting and recordkeeping under TSCA Section 8(a), which would require that persons who manufacture these nanoscale materials notify EPA of certain information, including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data. The notice regarding a TSCA Section 8(a) rulemaking was previously separate, but EPA states “those two efforts were combined into a single rulemaking.” EPA submitted a proposed rule regarding TSCA Section 8(a) reporting to the Office of Management and Budget (OMB) for review on November 22, 2010, where it remains. According to the notice, EPA intended to publish an NPRM in June 2011. Nothing has been published to date, however.

EPA Issues Final SNUR for Certain Multi-Walled Carbon Nanotubes

On May 6, 2011, the U.S. Environmental Protection Agency (EPA) promulgated a final significant new use rule (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the chemical substance identified generically as multi-walled carbon nanotubes (MWCNT), which was the subject of premanufacture notice (PMN) P-08-199. Under the final SNUR, persons intending to manufacture, import, or process MWCNT for a use that is designated as a significant new use by the final rule must notify EPA at least 90 days before commencing that activity. EPA states that it believes the final rule is necessary “because the chemical substance may be hazardous to human health,” and the required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. The final rule will be effective June 6, 2011.

EPA issued a proposed SNUR on February 3, 2010, and then on July 28, 2010, it reopened the comment period for 30 days to address public comment and add information to the docket. In the May 6, 2011, Federal Register notice, EPA states that, in response to comments on the basis for the proposed SNUR, EPA developed a revised summary document entitled “Summary of EPA’s Current Assessments of Health and Environmental Effects of Carbon Nanotubes,” which specifies EPA’s current hazard concerns as supported by available information and data. According to the May 6, 2011, notice, EPA considered comments on the proposed SNUR, and the final SNUR:

  • Retains the proposed workplace protection and specific use provisions as significant new uses;
  • Adds exclusions from applicability of the SNUR uses identified as ongoing; and
  • Identifies those forms of the subject PMN substance that are exempt from the provisions of the SNUR. These exemptions apply to quantities of the PMN substance:
    • After they have been completely reacted (cured);
    • Incorporated or embedded into a polymer matrix that itself has been reacted (cured); or
    • Embedded in a permanent solid polymer form that is not intended to undergo further processing except for mechanical processing.

NanoSafety Consortium Submits Proposed Testing Agreement to EPA

On April 6, 2011, several members of the NanoSafety Consortium submitted to the U.S. Environmental Protection Agency (EPA) a proposed testing agreement under Section 4 of the Toxic Substances Control Act (TSCA). Under the proposed testing agreement, the substances to be tested may include multi-walled carbon nanotubes, double-walled carbon nanotubes, single-walled carbon nanotubes, and graphene nanoplatelets. Participants would conduct 90-day inhalation toxicity studies in rats, and submit interim progress reports to EPA at 60-day intervals, and a final report within 120 days of the conclusion of testing. Under the proposed testing agreement, if EPA promulgated a TSCA Section 5(a)(2) significant new use rule (SNUR) applicable to the test substances, then the testing agreement would have the status of a TSCA Section 5(b)(1)(A) test rule. The NanoSafety Consortium asked that EPA “expeditiously consider” the proposed testing agreement and begin the public comment and negotiation process at its “earliest possible convenience.”

EPA Regulatory Agenda Includes Several Notices Concerning Nanoscale Materials

The U.S. Environmental Protection Agency’s (EPA) December 20, 2010, Regulatory Agenda includes several notices concerning nanoscale materials:

  • Test Rule for Certain Nanoscale Materials -- EPA states that it is developing a test rule under Section 4(a) of the Toxic Substances Control Act (TSCA) to require manufacturers (defined by statute to include importers) and processors of the multiwall carbon nanotube described in Premanufacture Notice (PMN) P-08-199, certain clays (e.g., kaolin (including halloysite) and bentonite (including montmorillonite)), alumina, and spray-applied nanomaterials to conduct testing for health effects, ecological effects, and environmental fate, as well as provide material characterization data. EPA intends to issue a notice of proposed rulemaking (NPRM) in April 2011.
  • Reporting Under TSCA Section 8(a) -- Under TSCA Section 8(a), EPA is developing a proposal to establish reporting requirements for certain nanoscale materials.  According to the notice, the rule would propose that persons who manufacture these nanoscale materials notify EPA of certain information including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data. The notice states that EPA intends to issue an NPRM in February 2011. EPA submitted a proposed rule to the Office of Management and Budget (OMB) for review on November 22, 2010.
  • Significant New Use Rule (SNUR) -- EPA is developing a SNUR for nanoscale materials under TSCA Section 5(a)(2).  The SNUR would require persons who intend to manufacture, import, or process this/these chemical substance(s) for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. EPA intends to issue an NPRM in February 2011.

EPA Issues Final SNURs for Carbon Nanotubes

On September 17, 2010, the U.S. Environmental Protection Agency (EPA) issued final significant new use rules (SNUR) for two chemical substances that were the subject of premanufacture notices (PMN). The two chemical substances are identified generically as multi-walled carbon nanotubes (MWCNT) (PMN P08177) and single-walled carbon nanotubes (SWCNT) (PMN P08328). Persons who intend to manufacture, import, or process either of these substances for a use that is designated as a significant new use by the final rule must notify EPA at least 90 days before commencing that activity. EPA states that it believes the SNURs are necessary because these chemical substances may be hazardous to human health and the environment. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. The final rule is effective October 18, 2010.

EPA issued direct final SNURs on these two substances on June 24, 2009. EPA withdrew the notices on August 21, 2009, after receiving notices of intent to submit adverse comments on the SNURs. EPA issued proposed SNURs on November 6, 2009. In response to comments on the applicability of the SNURs for these chemicals, EPA has included clarifying language for those forms of the subject PMN substances that are exempt from the provisions of the SNURs.  These exemptions apply to quantities of the PMN substances: after they have been completely reacted (cured); incorporated or embedded into a polymer matrix that itself has been reacted (cured); or embedded in a permanent solid polymer form that is not intended to undergo further processing except for mechanical processing. In response to comments on the basis for the SNURs, EPA developed revised human health effects and environmental effects summaries for carbon nanotubes (CNT).

EPA Reopens Comment Period for Multi-Walled Carbon Nanotube SNUR

On July 28, 2010, the U.S. Environmental Protection Agency (EPA) published a Federal Register notice announcing that it is reopening the comment period for its February 3, 2010, proposed significant new use rule (SNUR) for the chemical substance identified generically as multi-walled carbon nanotubes (P-08-199).  According to the July 28, 2010, notice, a commenter noted that neither the proposed rule nor the docket contained specific carbon nanotube data or data supporting the nature of the dermal concern for carbon nanotubes. The commenter stated it was not possible to assess EPA’s evaluation and determination based on the current record. Another commenter noted that EPA’s subsequent reviews and concerns for carbon nanotubes have expanded, and that the proposed SNUR should reflect those updated data. EPA states that it has added additional explanation and references of its health and environmental concerns for carbon nanotubes to the public docket for consideration, and is reopening the comment period for 30 days. Comments are due August 27, 2010.

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

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.

 

PPDC Discusses Nanotechnology and Pesticides

On April 29, 2010, during the U.S. Environmental Protection Agency’s (EPA) Pesticide Program Dialogue Committee (PPDC) meeting, William Jordan, Senior Policy Advisor, Office of Pesticide Programs (OPP), presented slides regarding nanotechnology and pesticides. Jordan briefly described how OPP is defining nanoscale materials and how the technology is being applied to the field of pesticides. His presentation described OPP’s recent consultation with EPA’s Scientific Advisory Panel (SAP) concerning nanosilver and other nanometal pesticide products, as well as other ongoing regulatory activity and future actions OPP intends to take.

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.

 

EPA Proposes a Second SNUR for Multi-Walled Carbon Nanotubes

The U.S. Environmental Protection Agency (EPA) published on February 3, 2010, a proposed significant new use rule (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for multi-walled carbon nanotubes. The proposed rule would require persons who intend to manufacture, import, or process the substance for an activity that is designated as a significant new use by the proposed rule to notify EPA at least 90 days before commencing that activity. EPA states that the required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. Comments are due March 5, 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.

EPA Proposes SNURs for Carbon Nanotubes

On November 6, 2009, the U.S. Environmental Protection Agency (EPA) proposed significant new use rules (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for two chemical substances that were the subject of premanufacture notices (PMN). EPA identified the substances generically as multi-walled carbon nanotubes and single-walled carbon nanotubes. According to the notice, these substances are subject to TSCA Section 5(e) consent orders issued by EPA. The consent orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The proposed SNURs are based on and consistent with the provisions in the underlying consent orders, and designate as a significant new use the absence of the protective measures required in the corresponding consent orders. Persons who intend to manufacture, import, or process either of these two substances for an activity that is designated as a significant new use would be required by the proposed rule to notify EPA at least 90 days before commencing that activity. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. Comments are due December 7, 2009.

EPA Withdraws Final SNURs for CNTs

Today’s Federal Register includes a notice from the U.S. Environmental Protection Agency (EPA) withdrawing the June 24, 2009, final significant new use rules (SNUR) for multi- and single-walled carbon nanotubes (CNT). EPA states that it published the final SNURs using direct final rulemaking procedures. Because EPA received a notice of intent to submit adverse comments on the rules, it is withdrawing the SNURs for CNTs. The Federal Register notice does not identify the commenter. The docket for the rulemaking includes a July 22, 2009, letter from WilmerHale stating that it intends to submit adverse comments on behalf of one or more clients. According to the notice, EPA “intends to publish in the Federal Register, under separate notice and comment rulemaking procedures, proposed SNURS for these two chemical substances.” The withdrawal is effective August 21, 2009.

EPA Clarifies Final CNT SNURs

On July 28, 2009, the U.S. Environmental Protection Agency (EPA) clarified its June 24, 2009, final Significant New Use Rules (SNUR) for multi- and single-walled carbon nanotubes (CNT).  According to EPA, upon review of the final rule, stakeholders asked whether the SNURs applied to all types of CNTs.  EPA responded:

 

This is not the case.  These SNURs only apply to the specific carbon nanotubes that were the subject of the premanufacture notices (PMN) submitted under Section 5 of TSCA and not to any other carbon nanotubes.  Other carbon nanotubes must be notified through EPA's New Chemicals Program.  The U.S. EPA strongly encourages all manufacturers and importers of nanoscale materials that are intended for commercial use to consult with the Agency in advance of production or importation.