Tag Archive for: Nanotechnology

EPA Proposes Significant New Use Rules for 37 Chemicals and Nanomaterials

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TSCA/SNUR/Nanotechnology:

Background

Continuing its robust exercise of its expansive TSCA authority, EPA last week released proposed Significant New Use Rules (“SNURs”) under TSCA for 37 chemicals, including 14 nanoengineered carbon compounds. The SNURs cover a wide range of uses, including the manufacture, processing, and import of adhesives, coatings, colorants, lubricants, chemical intermediates, etc., and result from premanufacture notice (“PMN”) submissions from as long ago as 2000. For almost half of the affected chemicals, the SNURs essentially codify protective measures already required under existing consent orders; the rest are largely based on PMN use scenarios.

EPA has already determined that 17 of the substances addressed by the proposed rule “may present an unreasonable risk of injury to human health or environment” and thus are subject to risk-based consent orders under TSCA § 5(e). The proposed SNURs for these substances adopt certain safety precautions already required by the consent orders. For example, for certain chemicals, workers would be required to wear specified respirators unless air monitoring shows that the substance is actually present in concentrations lower than the New Chemical Exposure Limit (“NCEL”). The NCEL provisions, already incorporated in the § 5(e) consent orders, were established by EPA “to provide adequate protection to human health” and modeled after Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs). Users who wish to pursue the NCEL alternative to the respirator requirement would have to request permission to do so under 40 CFR § 721.30 (“EPA approval of alternative control measures.”) EPA anticipates approving such requests under the same conditions already present in the consent orders.

The other 20 substances covered by the new SNURs are not subject to § 5(e) consent orders. These “non-5(e) SNURs” cover certain changes from the use scenarios described in the PMNs which could result in increased exposure, per 40 CFR § 721.170(c)(2).

In addition to personal protective equipment, the SNURs impose various standard use restrictions on the chemicals, such as prohibiting manufacture in the U.S., limiting use to conditions specified in existing consent orders, and banning release to water. EPA also recommends various types of toxicity testing to better characterize the new chemicals’ environmental effects.

Regulatory actions flowing from SNURs

Upon promulgation of the SNURs, any users of the affected substances will be required to determine whether they must submit a Significant New Use Notification (“SNUN”) to EPA 90 days prior to engaging in one of the designated “new uses.” On receipt of the SNUN, EPA may take further regulatory action under TSCA § 5(e), 5(f), 6 or 7, or otherwise publish a notice in the Federal Register explaining its reasons for not taking action.

In addition, EPA’s proposal of the SNURs triggers export notification requirements under TSCA § 12(b). Any exporter or intended exporter of the affected chemicals must notify EPA of the first export or intended export to a particular country, unless the substance is present at certain low concentrations that qualify for the de minimus exemption. If and when the SNURs are finalized, importers of the affected substances must also certify their compliance the SNURs.

EPA is accepting comments on the proposed SNURs through April 26, 2013.

Naming nanoscale materials and other CBI concerns

In the proposed SNURs, EPA identifies nanoengineered carbon compounds based on generic structural terms in order to protect the confidential chemical identities of the substances. EPA uses terms like, for example, “single-walled carbon nanotube” (or “SWCNT”), along with PMN numbers to identify the substances for inclusion in the TSCA Inventory.

The nomenclature developed by EPA is further described in a document, “Material Characterization of Carbon Nanotubes for Molecular Identity (MI) Determination & Nomenclature,” which should be available soon under the docket number EPA–HQ–OPPT–2012–0727. It is likely to be similar to or the same as the identically-named document published with the SNUR finalized in 2011 for a substance named as “multi-walled carbon nanotubes.”

If an intended user is uncertain whether its chemicals are subject to the new SNURs, EPA advises contacting the agency or obtaining a written determination under the bona fide procedures in 40 CFR § 721.11. Since production volume limits and certain other uses detailed in the proposed SNURs may also be claimed as CBI, users may not know whether their intended production volumes constitute a significant new use. The bona fide procedures also apply to such cases. If, after evaluating detailed submissions on the intended use, EPA finds that the user has a bona fide intent to manufacture, produce, or import the substance, the agency will advise whether the intended use would qualify as a significant new use.

France to require mandatory reporting of nanoscale materials in 2013

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Nanotechnology:

France will implement a compulsory declaration scheme for the quantities and uses of nanoparticle substances or nanomaterials produced in, distributed in, or imported to France January 1, 2013. Information about material identity, quantity, uses, and users will be required from all companies producing, distributing and importing nanomaterials, and public and private research laboratories. The declaration scheme will be implemented by the Ministries of Ecology, Sustainable Development, Transport and Housing; Economic, Financial and Industrial Affairs; Labor, Employment and Health; and Agriculture, Food, Fisheries, Rural Affairs and Planning. Detailed information on reporting requirements will be published in the Official Journal of the French Republic.

The reporting mandate was published February 19, 2012 in Decree 2012-232 (available in French only) (the December 2011 draft decree is available in English). The decree explains that the purpose of the scheme is to improve knowledge of nanomaterials and their uses, to monitor the channels of use, to improve knowledge of the market and the volumes sold and to collect available information on toxicological and eco-toxicological properties.  Data on 2012 nanomaterial use must be submitted by May 1, 2013.

Reporting requirements affect materials that are at least 50 percent comprised of particles with one or more external dimension between 1 nm and 100 nm. When any such material is produced, imported or distributed in quantities of 100 grams, the user must declare identity of the producer, importer, or distributor; identity of the nanomaterial; quantity of nanomaterial produced, distributed or imported; intended uses, and identifying information about the professional users to whom the material has been distributed. Specifics of the reporting requirements include:

  • Identity of the producer, importer, or distributor:
    • business name, official address, VAT number; and
    •  apacity (manufacturer, importer or distributor) and field of activity.
  • Identity of the nanomaterial:
    • chemical identification of the substance,
    • potential presence of impurities,
    • average particle diameter and particle size distribution,
    • specific surface,
    • surface coating, and
    • surface charge.

 

EPA Conditionally Registers Nanosilver Pesticide and NRDC Files Blocking Lawsuit

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FIFRA/Nanotechnology:

EPA’s Conditional Registration

On December 1, 2011, EPA announced that it was conditionally registering a pesticide product containing nanosilver as a new active ingredient. The antimicrobial pesticide product, HeiQ AGS-20, is a silver-based product for use as a preservative for textiles. As a condition of registration, EPA stated that it would require additional data on the product to confirm EPA’s assessment that the product will not cause unreasonable adverse effects on human health or the environment, the general standard for a registration under the Federal Insecticide, Fungicide, and Rodenticide Act.

By way of background, on August 12, 2010, EPA posted a Proposed Conditional Registration to the docket for public comment. EPA received 45 public comments, and responses to these comments along with the decision document to conditionally register the product can be found at www.regulations.gov in Docket ID # EPA-HQ-OPP-2009-1012. A description of the additional studies and timeline when the data must be submitted is also available in the docket.

NRDC’s Lawsuit

In response to the conditional registration, on January 26, 2012, the Natural Resources Defense Council filed a lawsuit in the 9th U.S. Circuit Court of Appeals, challenging EPA’s decision.  NRDC asserts that there is a lack of data concerning the human health and environmental effects of nanosilver.  The lawsuit seeks to limit public exposure to the nanosilver that EPA registered for use in clothing, baby blankets, and many other textiles.

Verdant will soon post a copy of the NRDC’s legal documents.  Check back soon for these documents and for further commentary on this important development for the nanotechnology community.

FDA Regulation of Nanotechnology

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Nanotechnology:

Readers interested in learning about FDA’s regulation of nanotechnology might want to download the free book available here:  FDA REGULATION OF NANOTECHNOLOGY .  Verdant attorney, Philip Moffat, and many others authored the book over the course of the past several years.  This book is a valuable resource to those wanting to learn about regulation in the United States of foods, cosmetics, drugs, medical devices and many other products that have been enhanced with nanotechnology.  Further information about FDA’s role in the regulation of nanotechnology may be found on the agency’s website, here.  Enjoy!

New EPA Rule for Carbon-Nanotubes

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Readers engaged in nanomaterial applications may be interested in EPA’s new Significant New Use Rule (SNUR) for multi-walled carbon nanotubes (MWCNTs). Enterprises wishing to manufacture, import, or process MWCNTS are now potentially subject to Significant New Use Notice (SNUN) regulatory procedures which include the submission of ‘appropriate’ health and safety data. This rule is incorporated into the Code of Federal Regulations at 40 CFR § 721.10183.

EPA evaluation of MWCNTs, and carbon nanotubes generally, has established that exposure may cause lung effects (pulmonary toxicity, fibrosis, carcinogenicity), immunotoxicity, and mutagenicity. More information on toxicological effects is reported in the Summary of EPA’s Current Assessments of Health and Environmental Effects of Carbon Nanotubes (available in the MWCNT SNUR Docket).

EPA recommends SNUNs provide detailed information on the following:

  • Human exposure and environmental release that may result from the significant new use of the chemical substance.
  • Potential benefits of the chemical substance.
  • Information on risks posed by the chemical substance compared to risks posed by potential substitutes.

EPA notes that upon review of a SNUN, the Agency has the authority to require additional testing. Any manufacturers, importers, or processors who intend to conduct testing or submit a SNUN are encouraged to contact EPA to determine ‘appropriate’ testing methods. Substantial detail about this and other governing TSCA provisions is provided in the FR notice (76 FR 26186 (available in the MWCNT SNUR Docket)). More information on SNUN requirements generally is available here and information on requirements for test data is available from EPA and the ACC.

This SNUR is specific to MWCNTs of a specific structure. However, confidentiality claims preclude a more detailed description of the identity of this MWCNT. To determine whether a specific CNT, MWCNT, or single-wall carbon nanotube is on the TSCA Inventory, manufacturers should submit a bona fide intent to manufacture or import to EPA.

Exempt from the rule are MWCNTs that are 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.

Reminder: Upcoming ABA Conference on the Governance of Nanotechnology

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Nanotechnology:

For readers interested in the environmental regulation of nanotechnology, you ought to seriously consider this program. The speakers are top-notch and the topics are timely and interesting.  Enjoy!

___________________________

ABA Webinar Thursday May 19

Nano Governance: The Current State of Federal, State, and International Regulation

Program: 1-5:30 p.m.

Networking Reception Immediately Following (DC site only)

No cost for in-person attendance

Washington, DC (register)

San Francisco, CA (register)

Durham, NC (register)

Webinar (register)

Overview:

The program will explore the new and creative applications of existing regulatory tools and governance approaches to address the potential risks of nanotechnologies, implement new risk assessment approaches to evolving technologies, and maximize the potential benefits of these materials. Speakers will discuss the approaches various government agencies are pursuing to accommodate evolving nanotechnologies and address potential public health and environmental impacts.

 Panelists:

Jim Alwood, Program Manager, Chemical Control Division, Office of Pollution Prevention and Toxics, U.S.

Raj Bawa, M.S., Ph.D., President of Bawa Biotechnology Consulting LLC, Ashburn, VA

Richard A. Denison, Ph.D., Senior Scientist, Environmental Defense Fund, Inc., Washington,

Steffi Friedrichs, Ph.D., Nanotechnology Industries Association, Brussels, Belgium

Steve Froggett, Ph.D., Froggett & Associates, Seattle, WA

Thomas R. Jacob, Coordinator, California Nanotechnology Initiative

William Jordan, Senior Policy Advisor, Office of Pesticide Programs, U.S. Environmental Protection Agency,

Neena Sahasrabudhe, Ph.D., Office of Pollution Prevention and Green Technology, California

Treye A. Thomas, Ph.D., Toxicologist, Directorate for Health Sciences, U.S. Consumer Product Safety Commission,

Rosalind Volpe, Ph.D., Executive Director, Silver Nanotechnology Working Group A Program of Silver Research

Impacts of Silver Nanoparticles on Wastewater Treatment

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Readers involved with industrial and commercial uses of nanomaterials may be interested in the Water Environment Research Foundation’s new report, Impacts of Silver Nanoparticles on Wastewater Treatment.

According to the report, silver nanoparticles from manufacturing and consumer products enter sewers and wastewater treatment plants in unknown quantities. For example, because silver nanoparticles are water soluble, as much as 100 percent of these particles might be able to leach out of clothing in just a few washes. In areas where industrial processes use these materials, concentrations of 0.1mg/L have been observed in municipal wastewater treatment plants.

Wastewater treatment processes generally reduce effluent levels to 10 percent or less of influent concentrations. This means that very low concentrations of silver may be reaching the receiving waters. However, because nanoparticles are more reactive than other forms of silver, many scientists and environmentalists are concerned about toxicity and environmental impacts. (See e.g., Silver Nanoparticles and Silver Nitrate Cause Respiratory Stress in Eurasian Perch, Aquatic Toxicology, January 2010; Nanometals Induce Stress and Alter Thyroid Hormone Action in Amphibia at or below North American Water Quality Guidelines, Environ. Sci. Technol., October 2010; Silver Nanotechnologies and the Environment: Old Problems or New Challenges, Project on Emerging Nanotechnologies, 2008)

WERF investigated the effects of these particles on activated sludge and anaerobic digestion. The research found that the nitrifying bacteria essential to removing ammonia from wastewater treatment systems were especially susceptible to inhibition by silver nanoparticles. Silver ions and silver nanoparticles concentrations as low as 0.4 mg/L inhibited the growth of nitrifying bacteria. In addition, anaerobic microbial activity in biomass (i.e., sewage sludge) was inhibited at silver nanoparticles concentrations of 19 mg/L.

WERF notes that the presence of nanoparticles during sludge treatment can have beneficial results. Recent WERF research has found that nanomaterials reduce the potential for odors in wastewater treatment and improve solids processing. (See Use of Nanomaterials for Biosolids Odor Reduction and Improved Dewaterability.)

Save the Date: Exciting Upcoming ABA Program on Nano Governance

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Nanotechnology:

For readers interested in the current state of play regarding governance of nanotechnology, the ABA Pesticides, Chemical Regulation and Right-To-Know Committee, along with other committees listed below, is organizing the following half-day event.

____________

SAVE THE DATE

January 27, 2011

NANO GOVERNANCE:  THE CURRENT STATE OF

FEDERAL, STATE, AND INTERNATIONAL REGULATION

Please mark January 27, 2011, on your calendar for an exciting program under development by the Pesticides, Chemical Regulation, and Right-to-Know Committee and the Science and Technology Section, Nanotechnology Committee. Program co-sponsors include the Young Lawyers Division Administrative Law and Environment Energy and Resources Law Committees and the Section on the Environment and Energy Resources, Environmental Disclosure Committee.

Program:  Nano Governance:  The Current State of Federal, State, and International Regulation

Date:  Thursday, January 27, 2011

Time:  1:00 – 5:30 p.m. (EST).  Networking reception immediately following.

Tentative Program Overview:

  1. The Federal Regulatory Outlook
  2. Beyond The Feds:  International/State Regulatory Programs and Strategies for Addressing Nanoscale Materials
  3. Perspectives from the Field

Questions:

More details to follow shortly, but for questions on this tentative program, please contact Irene A. Hantman at ihant001@umaryland.edu.

Also remember that the PCRRTK Committee web page provides you with access to valuable resource materials and analysis from past programs, newsletters, reports, and Practitioners E-reference documents covering a wide range of pesticide, chemical regulation, and right-to-know legal issues.  Please visit us at http://www.abanet.org/environ/committees/pesticides.

 

DTSC Announces New Date for the Public Workshop on Nanomaterials

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Nanotechnology:

The California Department of Toxic Substances Control (DTSC) announced a new date for its public workshop on nanomaterials.  State budget constraints forced the agency to reschedule the meeting from its original date of August 13.   The new date is Wednesday, September 22, 2010.  The workshop will be held at the U.S. EPA Region 9 office in San Francisco, California. 

Persons who previously registered are not required to re-register.   However, DTSC has circulated an email to registrants requesting confirmation of their plans to attend on the new date. 

At the workshop, DTSC and EPA will discuss the results of the carbon nanotube (CNT)  information call-in that DTSC recently completed, future activities by DTSC on other nanomaterial call-ins, and U.S. EPA efforts related to CNTs and future regulatory plans for other nanomaterials.

Reminder: DTSC Reschedules Meeting on Results of Information Call-In for Carbon Nanotubes

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Nanotechnology:

Due to state budget constraints, the California Department of Toxic Substances Control (DTSC) has had to reschedule its August 13 meeting on carbon nanotubes (CNTs) and other nanoscale chemicals substances and materials.  No new date has been provided.

DTSC was co-sponsoring the meeting with the US Environmental Protection Agency (EPA) and the University of California, Los Angeles.  The sponsors had planned to discuss the results of the CNT information call-in that DTSC recently completed, future activities by DTSC on nanomaterial call-ins, and U.S. EPA efforts related to carbon nanotubes and future regulatory plans for nanomaterials.

Although readers can register here to attend in-person or via teleconference, no new date for the event has been provided.