Nanotechnology Lawyer & Attorney : Porter Wright Morris & Arthur : Nanotechnology Law Report - Germanium nanobead image provided by UT-Battelle, which manages Oak Ridge National Laboratory for the Department of Energy

In the Federal Register issue of 08/13/2010, the Environmental Protection Agency (EPA) released for public comment a proposed rule that would, if adopted, significantly change the TSCA Inventory Update Reporting (IUR).

The first part of the notice, "Supplementary Information", explains the proposed changes to 40 CFR Parts 704, 710, and 711. The text of the proposed rule follows the Supplementary Information.

In the Supplementary Information, EPA states that it is proposing modifications to the IUR

 to meet four primary goals:
    1. To tailor the information collected to better meet the Agency's
overall information needs.
    2. To increase its ability to effectively provide public access to
the information.
    3. To obtain new and updated information relating to potential
exposures to a subset of chemical substances listed on the TSCA
Inventory.
    4. To improve the usefulness of the information reported.
EPA believes that expanding the range of chemical substances for which
comprehensive information is to be reported and adjusting the specific
reported information, the method and

[[Page 49659]]

frequency of collecting the information, and CBI requirements will
accomplish these goals.

Reading the Supplemental Information reveals a fifth, unstated goal - the creation of uniform reporting standards that will provide EPA with the information it needs to "identify and take follow-up action on chemical substances that may pose potential risks to human health or the environment" in a more efficent and timely manner, cutting the amount of time EPA staff will need to spend reviewing submitted information, determining if EPA action is required and uploading the information to a publicly available databse.

Under the proposed rule, EPA would require information to be submitted via agency supplied web based application

EPA believes the proposed requirement to use e-IURweb to report
electronically would eliminate problems related to the scanning of
paper documents, incorrect chemical identities, and other errors
introduced by the submitter. These errors substantially delayed the
availability of the IUR information to both internal EPA programs, such
as the Existing Chemicals Program, and the public. . . . EPA believes the
required use of e-IURweb and CDX would reduce the reporting burden on
industry by reducing both the cost and the time required to review,
edit, and transmit data to the Agency.

The terms manufacture, manufacturer, and site  would be redefined:

with this proposal . . . manufacture would be defined . . . to mean "to manufacture, produce, or import for commercial purpose.

Also with this proposal, manufacturer would be defined . . . to mean "a person who manufactures a chemical substance. "

The term site

would be defined under the IUR
rule to mean ``a contiguous property unit. Property divided only by a
public right-of-way shall be considered one site. More than one plant
may be located on a single site.
    (a) For chemical substances manufactured under contract, i.e., by a
toll manufacturer, the site is the location where the chemical
substance is physically manufactured.
    (b) The site for an importer who imports a chemical substance
described in 40 CFR 711.5 is the U.S. site of the operating unit within
the person's organization that is directly responsible for importing
the chemical substance. The import site, in some cases, may be the
organization's headquarters in the United States. If there is no such
operating unit or headquarters in the United States, the site address
for the importer is the U.S. address of an agent acting on behalf of
the importer who is authorized to accept service of process for the
importer.
    (c) For portable manufacturing units sent out to different
locations from a single distribution center, the distribution center
shall be considered the site.''
 

The proposed rule would also modify the definitions of the terms "commercial use", consumer use" "reporting year" "submission period" and add a definition for the term "industrial function".

The method of determining if a manufacturer or importer is subject to IUR reporting would be changed:

EPA is proposing to modify the method used to determine whether a
person is subject to IUR reporting. The proposed method would be to
determine whether, for any calendar year since the last principal
reporting year, a chemical substance was manufactured (including
imported) at a site in production volumes of 25,000 lb. or greater. The
proposed method would be effective after the 2011 IUR submission
period.
 

EPA is proposing this change because of the mounting evidence that
many chemical substances, even larger volume chemical substances, often
experience wide fluctuations in manufacturing volume from year to year.
 

Chemical substances coverd by IUR reporting would be changed to exempt water, both naturally occuring and manufactured, fully exempt the polymers starch, dextrin, and maltodextrin, and making chemical substances subject to enforceable consent decrees ineligible for exemption.

Data to be reported would change as well. The company name to be reported would be the name of the parent company, including its Dunns & Bradstreet (DNB) number, the chemical name(s) supplied would be the name as listed on the TSCA Inventory, production volume of chemicals manufactured, exported and/or imported would be reported on one report rather than multiple reports. A check box, to indicate if a chemical substance is to be recycled, remanufactured, reprocessed, reused or reworked would be added.

Among other changes, EPA is proposing to revise and expand the list of industrial function categories and replace the NAICS codes with Industrial Sector Codes based on the European Union's "Guidance on information requirements and chemical safety assesment". The codes for consumer and commercial product categories would also be revised.

These lists of codes would be revised to bring them into harmony with existing codes used in Canada, to better facilitate the exchange of information between EPA and its Canadian counterpart and to serve as a model for Mexican agencies to develop an inventory of chemical substances.

Manufacturers and importers would be required to report the "total number of commercial workers likely to be exposed while using the reportable chemical substance(s):

iii. Number of commercial workers reasonably likely to be exposed.
EPA is proposing to require that submitters report the total number of
commercial workers, including those at sites not under the submitter's
control, that are reasonably likely to be exposed while using the
reportable chemical substance, with respect to each commercial use. The
approximate number of workers would be reported using the same
definitions and ranges used for manufacturing and industrial processing
and use workers required by 40 CFR 710.52(c)(3)(v) and (4)(i)(F)
(proposed 40 CFR 711.15(b)(3)(vii) and (4)(i)(F)), respectively. The
ranges are:

    Fewer than 10 workers.
    At least 10 but fewer than 25 workers.
    At least 25 but fewer than 50 workers.
    At least 50 but fewer than 100 workers.
    At least 100 but fewer than 500 workers.
    At least 500 but fewer than 1,000 workers.
    At least 1,000 but fewer than 10,000 workers.
    At least 10,000 workers.

    Information on the number of commercial workers reasonably likely
to be exposed to the reportable chemical substance would be used to
characterize the commercial population reasonably likely to be exposed
to the subject chemical substance. The population characterization is
important to the development of the overall exposure characterization.
 

Claims of "Confidential Business Information" - also known more commonly as "trade secrets" - would be required to be substantiated and claimed at the time the IUR is submitted and "should be limited only to those data elements the release of which would likely cause substantial harm to the business' competitive position. . . . EPA expects that reducing the number of CBI claims would increase the amount of information available to the public and improve the timeliness of its public availability". In a previous section, EPA noted that manufacturers would submit claims for CBI on information that was publicly available from other sources and thus was not CBI at all.

In Unit V of of the Supplemental Information, EPA requests comments on the proposed rule and various other topics, ranging from how best to use IUR data to take action on chemical substances that might pose "unreasonable risks" with particular emphasis on protecting children from exposure to harmful chemical substances to changing the reporting cycle, changes in how EPA should collect the information, and whether IUR reporting requirements should be changed to include processors as well as manufacturers and importers.

Comments must be submitted by October 12, 2010. The notice describes how comments need to be submitted. After receiving and reviewing the comments submitted, EPA hopes to publish a final rule in Spring 2011. As with any proposed rule submitted for public comment by any Federal agency, there may be a "Notice of Further Proposed Rulemaking" (NPRM) or the agency may also issue an interim rule before the final rule is published.

EPA has established a docket (EPA-HQ-OPPT-2009-0187) on www.regulations.gov  where documents referenced in the Supplemental Information and comments on the proposed rule may be found.

A shorter discussion of the proposed rule may also be found on the OMB Watch website.

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In a notice published in the Federal register on July 28, 2010, the Environmental Protection Agency (EPA) announced that it was adding new information to its public docket EPA-HQ-OPPT-2009-0686 and was reopening the comment period for  a proposed Significant New Use Rule (SNUR) for multiwalled carbon nanotubes (MWCNTS) first published in the Federal Register on February 3, 2010.

The proposed rule requires "persons who intend to manufacture, import, or process the substance" - described elsewhere in the notice as "multi-walled carbon nanotubes(generic)" to "be used as an additive/filler for polymer composites and support media for industrial catalysts" - "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". This would give EPA time to assess "risks that may be presented by the intended uses and, if appropriate, to regulate the proposed use before it occurs."

Information regarding submission of comments will be found in the original notice of February 3, 2010.

The "Significant New Use" for the MWCNTS (generic) are described in the Feb. 3, 2010 notice as

certain changes from the use scenario described in the
PMN could result in increased exposures, thereby constituting a
``significant new use.'' EPA has determined that activities proposed as
a ``significant new use'' satisfy the two requirements stipulated in
Sec.  721.170(c)(2), i.e., these significant new use activities, ``(i)
are different from those described in the premanufacture notice for the
substance, including any amendments, deletions, and additions of
activities to the premanufacture notice, and (ii) may be accompanied by
changes in exposure or release levels that are significant in relation
to the health or environmental concerns identified'' for the PMN
substance.
 

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 Sec.  721.170(b)(3)(ii).
 

Following the closing of the comment period and review of the comments received, EPA will publish summaries and EPA's replied to the submitted comments in a future issue of the Federal register, along with the final rule.

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On Friday, the United States Government Accountability Office issued its Report to the Chairman (Barbara Boxer) of the Committee on Environment and Public Works, US Senate, GAO-10-549:

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

Highlights from the report follow.  The report confirms speculation that EPA intends to issue certain new rules pertaining to select nanomaterials by the end of 2010.

Background

"EPA has taken a mulitpronged approach to understanding and regulating the risks of nanomaterials, including conducting further research and implementing a voluntary data collection program. Furthermore, under its existing statutory framework, EPA has regulated some nanomaterials but not others. Although the EPA is planning to issue additional regulations later this year, these changes have not yet gone into effect and products may be entering into the market without EPA review of all available information on their potential risk. Moreover, EPA faces challenges in effectively regulating nanomaterials that may be released in air, water, and waste because it 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."

TSCA

"In the fall of 2009, EPA announced it would reconsider the policy described in its January 2008 document, TSCA Inventory Status of Nanoscale Substances -- General Approach, and subsequently announced it planned to develop a SNUR to regulate nanoscale versions of conventional scaled chemicals that are already on the TSCA inventory as a significant new use of that chemical. The agency intends to propose this rule in December 2010."

"TSCA also gives EPA authority to issue rules requiring companies to submit certain information about chemicals. EPA plans to issue one such rule for nanomaterials that would require manufacturers to provide information on production volume, methods of manufacture and processing, and exposure and release, as well as available health and safety studies. Evaluation of this information will provide EPA with an opportunity to consider appropriate action under TSCA to reduce unreasonable risks to human health or the environment, according to EPA. This rule may also help them collect information on nanomaterials not covered by the SNUR discussed above. EPA intends to propose this rule in December 2010."

"EPA officials told us they intend to propose a rule in December 2010 that would require companies to generate test data on the health effects of 15 to 20 different nanomaterials, including carbon nanotubes, nanoclays, and nano aluminum, and also on nanomaterials used in aerosol-applied products. This information will help EPA correlate the properties of these materials with specific health effects, manage or minimize risk and exposure, and help EPA determine the need for additional testing of these materials, according to EPA. EPA officials told us they will be working with the National Institute for Safety and Health Administration, and the Consumer Product Safety Commission on this effort."

FIFRA

"EPA officials told us that if a company replaces a conventionally sized active ingredient in a pesticide with a nanoscale version of that ingredient, it is mandatory for the company to amend its registration. Officials also noted, however, that the agency's position on this point needs to be made explicit to the regulated community and such a clarification could be made in EPA guidance. According to stakeholders, manufacturers of nanopesticides are required to obtain an amended registration in such a circumstance even without new EPA guidance explicitly requiring it since the registration requirement is based not only on questions of chemical identity, but also on claims made about the pesticide; its composition; and its chemistry, toxicology, and other information."

GAO's Recommendations

"We recommend that the Administrator of EPA, take the following three actions:

• Complete its plan to issue a Significant New Use rule for nanomaterials.
• Modify FIFRA pesticide registration guidelines to require applicants to identify nanomaterial ingredients in pesticides.
• 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.

In addition, 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 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; and
• use information-gathering provisions of the Clean Water Act to collect information about potential discharges containing nanomaterials.

Finally, the Administrator of EPA should consider revising the Inventory Update 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's May 4, 2010 Response to GAO

Finally, attached as an exhibit to the report was a written response from EPA in which the agency largely agreed with all of GAO's recommendations. Regarding GAO's Clean Water Act recommendation, EPA stated that its Office of Research and Development is currently developing methods to detect nanomaterials in water and predict levels of concern. Once able to detect and measure nanomaterials in water, EPA will then consider whether reporting requirements should be amended.

We will continue to monitor these issues and provide timely updates to our readers.

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Last September we predicted that sometime in 2010 EPA would reverse its "distinct molecular identity" approach to determining when and whether nanoscale materials are considered New Chemical Substances requiring premanufacturing notice and approval under the Toxic Substances Control Act (TSCA).   We have been advising clients accordingly. 

Inside EPA is now reporting that "EPA toxics chief Steve Owens" . . . "is expected to announce the shift Feb. 5."

Thus, tomorrow should be an interesting day in nano-regulatory-land.  We will provide our readers with a detailed analysis should EPA in fact reverse itself on this important issue.  Stay tuned . . .

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New Edition of Nanotechnology Law Report

Inside you will find:

• EPA Considering New Approach to Nanoscale Materials Under TSCA
• EPA May Issue Mandatory Data Collection Rule for Nanoscale Materials Under TSCA
• EPA Takes Aim at Antimicrobial Products Under FIFRA
• EPA Unveils New Principles for Chemical Management Reform
• EPA Report on the Use of Nanoscale TiO2 in Water and Sunscreens
• EPA Withdraws Carbon Nanotube SNURs
• Press Release: New Contributing Editor for InterNano
• Virginia CLE presentation: “Insurance, Nanotechnology, and Risk”
• Nanoparticles and Deaths in the People’s Republic
• Sweating the Small Stuff
• Soil Association Cites China Deaths in Renewed Call for Moratorium on Nanotechnology Commercialization
• Nanotechnology Legislation in the 111th Congress
• Mapping Nano
• Flight of the Nanobees

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Nanotechnology Law & Business just published our new article on the EPA's recent treatment of nanoscale materials under the Toxic Substances Control Act.  An abstract for the article is below and you can find a copy of the article itself here.

Abstract: This article provides a summary of recent (2008-2009) regulatory efforts by the U.S. Environmental Protection Agency under the Toxic Substances Control Act concerning nanoscale materials. These efforts include entering into two consent orders with a manufacturer of carbon nanotubes; issuing four significant new use rules for two siloxane-based nanoparticles and two carbon nanotubes (and then withdrawing the latter two); intimating that new testing and data collection rules will be implemented for certain nanoscale materials; and proposing and/or requiring acute toxicity rat inhalation testing regimes in certain instances. The authors explain these developments in detail and then provide some initial strategic and legal considerations for businesses attempting to navigate this emerging regulatory thicket.

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In recent weeks, Health care reform and financial regulatory reform efforts by the Obama administration have been getting the majority of the media and public's attention, but at the same time reform and updating of the Toxic Substances Control Act (TSCA) has been in the background.

Yesterday, during a speech to the Commonwealth Club of San Francisco EPA Administrator Lisa Jackson announced the administration's "Essential Principles for Reform of Chemicals Management Legislation". Some of the principles that Ms. Jackson highlighted in her speech are:

First, we need to review all chemicals against safety standards that are based solely on considerations of risk – not economics or other factors – and we must set these standards at levels that are protective of human health and the environment.

Second, safety standards cannot be applied without adequate information, and responsibility for providing that information should rest on industry. Manufacturers must develop and submit the hazard, use, and exposure data demonstrating that new and existing chemicals are safe. If industry doesn’t provide the information, EPA should have the tools to quickly and efficiently require testing, without the delays and procedural obstacles currently in place.

Third, both EPA and industry must include special consideration for exposures and effects on groups with higher vulnerabilities – particularly children. Children ingest chemicals at a higher ratio to their body weight than adults, and are more susceptible to long-term damage and developmental problems. Our new principles offer them much stronger protections.

Fourth, when chemicals fall short of the safety standard, EPA must have clear authority to take action. We need flexibility to consider a range of factors – but must also have the ability to move quickly. In all cases, EPA and chemical producers must act on priority chemicals in a timely manner, with firm deadlines to maintain accountability. This will not only assure prompt protection of health and the environment, but provide business with the certainly that it needs for planning and investment.

Fifth, we must encourage innovation in green chemistry, and support research, education, recognition, and other strategies that will lead us down the road to safer and more sustainable chemicals and processes. All of this must happen with the utmost transparency and concern for the public’s right to know.

Finally, we need to make sure that EPA’s safety assessments are properly resourced, with industry contributing its fair share of the costs of implementing new requirements.

 

Its been expected for some time that new legislation to update the TSCA will be introduced by Senators Frank Lautenberg, Barbara Boxer, Representatives  Henry Waxman and Bobby Rush before the end of the 111th Congress 1st Session. We'll keep an eye out for when the legislation is introduced and it's course through Congress.

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Eight months after EPA's interim report on industry participation (or lack thereof) in its Nanoscale Materials Stewardship Program, EPA's Toxic Substances Control Act's ("TSCA") Interagency Testing Committee ("ITC") published a report in today's Federal Register mentioning that EPA intends to issue a new mandatory data collection rule for nanoscale materials under TSCA Section 8(a):

"EPA intends to develop a proposed TSCA section 8(a) rule to obtain information on the production, uses, and exposures of existing nanoscale materials.  EPA has indicated that it will ensure that the chemicals where there is ITC interest as described in this unit are either included in that action or are otherwise new chemical substances subject to premanufacture notifications (PMN) reporting under TSCA.  EPA also intends to develop a proposed TSCA section 4 rule to develop needed environmental, health, and safety data."

Among other things, TSCA section 8(a) allows EPA to issue a rule requiring the mandatory submission of data regarding:

(A) The common or trade name, the chemical identity, and the
molecular structure of each chemical substance or mixture for which
such a report is required.

(B) The categories or proposed categories of use of each such
substance or mixture.

(C) The total amount of each such substance and mixture
manufactured or processed, reasonable estimates of the total amount
to be manufactured or processed, the amount manufactured or
processed for each of its categories of use, and reasonable
estimates of the amount to be manufactured or processed for each of
its categories of use or proposed categories of use.

(D) A description of the byproducts resulting from the
manufacture, processing, use, or disposal of each such substance or
mixture.

(E) All existing data concerning the environmental and health
effects of such substance or mixture.

(F) The number of individuals exposed, and reasonable estimates
of the number who will be exposed, to such substance or mixture in
their places of employment and the duration of such exposure.

(G) . . . the manner or method of its disposal, and in any
subsequent report on such substance or mixture, any change in such
manner or method.
 

Some of the nanoscale materials prompting ITC's interest appear to be: fullerenes; titanium oxide nanowires; titanium oxide nanoparticles; nano zinc oxide; nanosilver; silica; quartz; cerium oxide; indium tin oxide; dendrimers; single-walled carbon nanotubes; multi-walled carbon nanotubes; carbon nanofibers; Se and Cd quantum dots; nanoceramic particles; and nanoclays.

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Readers may interested in learning that EPA issued a clarification today regarding its single-walled and multi-walled carbon nanotube SNURs previously issued in June 2009. EPA's announcement follows.  Stay tuned . . .

Good afternoon.  On June 24, 2009, the U.S. EPA issued final Significant New Use Rules (SNURs) under the Toxic Substances Control Act (TSCA) for 23 new chemicals, including two carbon nanotubes (nanoscale materials) (http://www.epa.gov/fedrgstr/EPA-TOX/2009/June/Day-24/t14780.pdf).  The SNURs will allow the commercialization of these specific carbon nanotubes under limited conditions to protect against unreasonable risks to human health and the environment.  

The SNURs require companies to notify EPA at least 90 days before manufacture, import, or processing of the specific carbon nanotubes for any activity not meeting the conditions specified in the rules at 40 C.F.R. 721.10155  and 40 C.F.R. 721.10156.

Upon reviewing the rules some stakeholders have asked EPA whether these SNURs apply to all variants of carbon nanotubes. This is not the case. These SNURs only apply to the specific carbon nanotubes that were the subject of the premanufacture notices (PMNs) 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.

If you have any questions, please contact:

Zofia Kosim (202-564-8733) or kosim.zofia@epa.gov
Jim Alwood (202-564-8974) or alwood.jim@epa.gov
--------------------------------------------------------------------
David E. Giamporcaro
Industry and Small Business Liaison
Environmental Assistance Division
Office of Pollution Prevention and Toxics
U.S. Environmental Protection Agency
East Building
1200 Pennsylvania Avenue, N.W. (MC7408M)
Washington, D.C. 20460
Phone: (202)564-8107
Fax: (202)564-8813

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In the June 24, 2009 federal register, the U.S. Environmental Protection Agency (EPA) issued two proposed Significant New Use Rules (SNUR) under Section 5(a) of the Toxic Substances Control Act (TSCA) for multi-walled and single walled carbon nanotubes.  The SNURs followed up on the EPA's prior September 2008 consent orders entered into with Thomas Swan & Co. Ltd. (Swan) for two of its Elicarb carbon nanotube products.

Under TSCA, the prior September 2008 consent orders were only binding on Swan.  "Consequently, after signing a Section 5(e) Consent Order, EPA generally promulgates a Significant New Use Rule (SNUR) that mimics the Consent Order to bind all other manufacturers and processors to the terms and conditions contained in the Consent Order.  The SNUR requires that manufacturers, importers and processors of certain substances notify EPA at least 90 days before beginning any activity that EPA has designated as a "significant new use. These new use designations are typically those activities prohibited by the Section 5(e) Consent Order."

Under the terms of the Septmeber 2008 consent orders which are incorporated into the new proposed SNURs, significant new uses of multi-walled and singled-walled carbon nanotubes are deemed to occur when employees do not “use gloves impervious to nanoscale particles and chemical protective clothing;” and/or fail to “use a NIOSH-approved full-face respirator with an N-100 cartridge while exposed by inhalation in the work area.”

Thus, the new proposed SNURs require these same conditions.

Manufacturers should also be aware that the EPA considers carbon nanotubes new chemical substances requiring full PMN notice, registration, and approval under Section 5 of TSCA, and has initiated at least one recent enforcement action against a carbon nanotube manufacturer who has failed to properly register its products.

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Earlier today, the EPA published an interim status report regarding its Nanoscale Materials Stewardship Program.  A final report is expected in early 2010.

Nanoscale Materials Stewardship Program, Interim Report, January 2009, U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics.

At the outset, EPA notes that "[t]he findings and conclusions [of the] report should not be construed or interpreted to represent any Agency regulatory or statutory guidance or statement of official Agency policy."   Several companies submitting NMSP data should be relieved by this disclaimer, as EPA identified 18 nanoscale materials in NMSP submissions which may be considered new chemical substances under TSCA and subject to premanufacturing notice requirements.  Whether EPA takes any enforcement steps in this regard remains to be seen.

Getting to the highlights of the report, EPA concludes that the NMSP has (thus far) produce mixed results:

• "In the aggregate, the NMSP has sufficiently advanced EPA’s knowledge and understanding to enable the Agency to take further steps towards evaluating and, where appropriate, mitigating potential risks to health and the environment."
• "It appears that nearly two-thirds of the chemical substances from which commercially available nanoscale materials are based were not reported under the Basic Program."
• "It appears that approximately 90% of the different nanoscale materials that are likely to be commercially available were not reported under the Basic Program."
• "The low rate of engagement in the In-Depth Program suggests that most companies are not inclined to voluntarily test their nanoscale materials."

EPA's overall conclusion is that:

"[T]he NMSP can be considered successful. However, a number of the environmental health and safety data gaps the Agency hoped to fill through the NMSP still exist. EPA is considering how to best use testing and information gathering authorities under the [TSCA] to help address those gaps."

My own view is that response to the NMSP has been lukewarm, at best.

Analysis of Current Submissions

As of December 8, 2008 information under the Basic Program has been submitted by 29 companies/associations, covering 123 nanoscale materials.  Seven additional companies have also committed to submitting data under the Basic Program at a future date.  The In-Depth Program has commitments from four companies thus far.   Additionally, the American Chemistry Council (ACC) has expressed an interest in coordinating In-Depth data submissions. 

A chart from the interim report breaking down Basic Program submissions by material type follows.  Nanoscale metals and metal oxides predominate.  Many materials are still in the research and development stage.

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This article, which appeared in the Nov. 17, 2008 issue of Pesticide & Toxic Chemical News, Volume 37, No. 3, was reproduced with permission from Agra Informa. Further use of this article is prohibited without the express written permission of the publisher. For more information about Pesticide & Toxic Chemical News, Food Chemical News or other Agra Informa publications, go to: www.foodregulation.com .

EPA earlier this month announced it is promulgating significant new use rules (SNURs) under TSCA for two nanomaterials — siloxane modified silica nanoparticles and siloxane modified alumina nanoparticles — that were subject to premanufacture notices (PMNs). Some stakeholders view the move as a further sign that EPA is willing to use its authority to regulate nanomaterials, although to what extent remains uncertain.

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Today, US EPA issued a Federal Register notice stating the Toxic Substances Control Act (TSCA) registration requirements are "potentially applicable to carbon nanotubes."  EPA confirmed its position the CNTs are "chemical substances distinct from graphite or other allotropes of carbon listed on the TSCA inventory."  The bottom line is stated succinctly by EPA: "Many CNTs may therefore be new chemicals under TSCA Section 5."

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The EC's 2006 Registration, Evaluation, Authorisation and Registration of Chemicals ("REACH") regulations place "the responsibility for the management of the risks of [chemical] substances with. . .[the companies that] manufacture, import, place on the market or use [the] substances in the context of their professional activities."  Guidance on Registration, Guidance for the Implementation of REACH, European Chemicals Agency, Version 1.3, May 2008, at p. 12.  

To this end, REACH requires companies manufacturing or importing chemical substances in quantities greater than one ton per year to register those substances before they "can be manufactured, imported or placed on the market."  As part of these requirements, "manufacturers and importers need to collect or generate data on the substances and assess how risks to human health and environment can be controlled by applying suitable risk management measures."  This can often be an expensive and time consuming process.

Providing some relief in certain circumstances, Article 2(7)(a) of Regulation (EC) No 1907/2006 provides that certain substances are exempt from registration under REACH because "sufficient information is known about these substances that they are considered to cause minimum risk because of their intrinsic properties." These substances are listed in REACH Annex IV.

On October 8, 2008, the EC removed carbon and graphite from Annex IV "due to the fact that the concerned Einecs and/or CAS numbers are used to identify forms of carbon or graphite at the nano-scale, which do not meet the criteria for inclusion in" Annex IV.   We first posted on this possibility last June.

Commission Regulation (EC) NO 987/2008 of 8 October 2008 Amending Regulation (EC) No 1907/2006 of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes IV and V.

This decision is consistent with the U.S. Environmental Protection Agency's reasoning that nanoscale substances with new molecular identities -- such as fullerenes and carbon nanotubes -- are considered new chemical substances for purposes of premanufacturing notice submissions under the Toxic Substances Control Act.
 

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Last month we reported on a press release by Thomas Swan & Co. Ltd. of the United Kingdom indicating the company had recently entered into a PMN consent order with the EPA under the Toxic Substances Control Act (“TSCA”) concerning one of its multi-walled carbon nanotube (MWCNT) products. Barring an unusual coincidence, it appears that EPA has recently published a redacted version of the Swan Consent order here.

The order makes it clear that the PMN was submitted pursuant to § 5(a)(1) of TSCA, and that it covers a MWCNT product. Additionally, the consent order places several requirements on the manufacturer. Specifically, the manufacturer is required to:

1. Deliver 1 gram of the MWCNTs to EPA with a copy of MSDS for the product;
2. Conduct “90 day inhalation toxicity study in rats with a post exposure; observation period of up to 3 months, including bronchoalveolar lavage fluid (“BALF”) analysis (OPPTS 870.3465 or OECD 413);
3. Submit material characterization data within six months (see below);
4. Ensure employees “use gloves impervious to nanoscale particles and chemical protective clothing;” and
5. Ensure employees “use a NIOSH-approved full-face respirator with an N-100 cartridge while exposed by inhalation in the work area.”

Regarding the second requirement, the consent order also provides the manufacturer with an opportunity to submit toxicity testing data under the Agency’s new Nanoscale Material Stewardship Program as an alternative to the 90 day mouse inhalation test: “If, for example, a consortium of companies commit to testing a representative set of MWCNT for subchronic mammalian toxicity, EPA may consider waiving the triggered testing requirement. EPA would be willing to facilitate the process in coordination with other ongoing health effects testing for MWCNT nationally and internationally. EPA would consider accepting the results of such testing in lieu of triggered testing in this order.”
 

Regarding material characterization information, EPA is requiring the manufacturer to submit the following within six months:

• Type of multi-walled carbon nanotube (concentric cylinders or scrolled tubes; number of walls/tubes);
• Configuration of nanotube ends (e.g., open, capped);
• Description of any branching;
• Width/diameter of inner most wall/tube (average and range);
• Carbon unit cell ring size and connectivity;
• Alignment of nanotube along long axis (straight, bent, buckled);
• Hexagonal array orientation used in the manufacture of the nanotube;
• Particle size of catalyst used in the manufacture of the nanotube;
• Molecular weight (average and range); and
• Particle properties: shape, size (average and distribution), weight (average and distribution), count, surface area (average and distribution), surface to volume ratio, aggregation/agglomeration.

Finally, manufacturers of MWCNTs (other than Thomas Swan) will be interested in two of EPA’s general legal conclusions expressed in the consent order:

“EPA is unable to determine the potential for human health effects from exposure to the PMN substance. EPA therefore concludes, pursuant to § 5(e)(1)(A)(i) of TSCA, that the information available to the Agency is insufficient to permit a reasoned evaluation of the human health effects of the PMN substance.”

“In light of the potential risk to human health posed by the uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance, EPA has concluded, pursuant to § 5(e)(1)(A)(ii)(I) of TSCA, that uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance may present an unreasonable risk of injury to human health.”

No doubt other MWCNT manufacturers will feel the need to file PMN’s for their products similar to Thomas Swan given the language of the consent order.

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As Mike Heintz reported earlier today, the Woodrow Wilson International Center for Scholars' Project on Emerging Nanotechnologies issued a report yesterday providing some guidance regarding where it believes the next administration should start with the issue of nanotechnology regulation next January.

J. Clarence Davies, "Nanotechnology Oversight: An Agenda for the New Administration," Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, PEN 13, July 2008.

Among other suggestions, Mr. Davies advocates enacting new nano-specific legislation in the following areas.

TSCA: Mr. Davies offers specific legislative language for amending TSCA "to make clear that nanomaterials are covered as new substances." Other changes he suggests: "remove the catch-22 that requires EPA to show that a new chemical poses a risk before the agency can obtain enough information to determine whether it actually poses a risk;" "remove the conditions and requirements that guarantee that EPA can never regulate an existing substance;" and narrow TSCA’s confidential business information and data sharing provisions.

FFDCA: Mr. Davies argues the FFDCA should be amended to require submission and review by FDA of cosmetic active ingredient registration information.  He further maintains that "FDA should also be authorized to forbid marketing of any cosmetic containing an ingredient that is not safe or for which adequate test data are not available," and that applicable FDA laws should be altered "to make clear where and how to draw the line between a drug and a cosmetic."  Mr. Davies additionally recommends requiring premarket safety testing on food and cosmetic ingredients incorporating nanoscale materials, and increased post-marketing surveillance and reporting.

DSHEA: Mr. Davies calls for amending DSHEA so that it does not prohibit "FDA from imposing testing or approval on dietary supplements (vitamins, herbs, etc.) and placing the burden of proof on FDA to provide that a supplement is safe."

Other recommendations by Mr. Davies beyond long-term regulatory action are:

Research: dramatically increase federal nano-related EHS research funding (FY 2009 - $100 million; FY 2010 - $150 million), require a federal peer-reviewed EHS research plan; strengthen NNI; encourage separation of NNI promotional and oversight functions; and establish a Nanotechnology Effects Institute.

Regulatory Coordination: establish an interagency group devoted solely to nanotechnology regulation; develop a nanotechnology plan within each agency; and improve intergovernmental coordination.

Resource Requirements: increase regulatory agency budgets and staffing.

EPA: define nanomaterials as "new" chemical substances and/or "significant new uses" of existing chemical substances under TSCA; promulgate a new compulsory information collection rule under TSCA Section 8; expand regulation of anti-microbials under federal pesticide law; promote "green" technology; and evaluate the application of other EPA statutes to nanotechnology.

FDA: establish criteria for determining which nanomaterials are "new" for regulatory purposes; collect information on safety testing, forthcoming products and adverse effects; regulate cosmetics and dietary supplements.

OSHA: communicate to workers and firms about nanotechnology; use existing OSHA regulations to deal with nanoparticles; issue OSHA standards for nanomaterials.

CPSC: hire new staff to study nanotechnology exposure; create a chronic hazard advisory panel for nanotechnology products posing significant exposure risks.

Voluntary Efforts: use the DuPont-Environmental Defense framework as a basis for analyzing nanotechnology risks; issue a nanotechnology handbook for small businesses.

Public Involvement: give the public more information about nanotechnology; obtain the public's views about nanotechnology; convene a stakeholder dialogue.

Mr. Davies concludes his article with an interesting analogy: "[N]anotechnology comes in a treasure chest of riches and a Pandora's box of evils. The challenge of the new century and to the new administration is to use the treasure while keeping shut the lid on the Pandora's box."

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Environmental Science & Technology recently released an editorial discussing nanotechnology safety issues and, more importantly, the recent debate over whether EPA should regulate nanoscale materials as new chemicals under TSCA.  The editorial succinctly sets forth EPA's position, as expressed by Jim Willis, EPA's Chemical Control Division Director, on the TSCA issue this way: 

In an EPA document, TSCA Inventory Status of Nanoscale Substances—General Approach, released on July 12, the agency explained why it could not group all nanomaterials as new substances solely on the basis of size. This is because the definition of a new chemical under TSCA is based on only molecular structure or identity. If a nanomaterial contains the same molecules as a chemical already in the TSCA inventory, it is an existing chemical, says Willis. And almost all nanomaterials being researched and manufactured today are chemically identical to existing chemicals in the TSCA inventory. Thus, EPA has no authority to regulate them. Carbon nanotubes and fullerenes, for example, are made of carbon, an existing chemical in the inventory.

h/t to TGDaily.com.

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New chemical substances that are not on EPA's existing Toxic Substances Control Act (TSCA)chemical inventory are subject to premanufacturing notice and approval requirements.  Many NGOs have urged EPA to treat all nanoscale materials as new chemical substances under TSCA because of potential environmental, health, and safety concerns shown in laboratory settings.  Such treatment would trigger TSCA's premanufacturing notice and approval requirements.  This past July, EPA indicated it did not currently intend to accept this approach because it considers "new" chemicals as those that have molecular identities that are not reflected on the inventory.

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Just a reminder to those interested in commenting on US EPA's draft documents concerning the Nanoscale Materials Stewardship Program (NMSP): comments are due to the Agency on or before September 10, 2007. 

US EPA is seeking comments on three draft publications: the "Concept Paper for the Nanoscale Materials Stewardship Program under TSCA, " the "TSCA Inventory Status of Nanoscale Substances - General Approach," and the Information Collection Request (ICR) in Support of EPA’s Stewardship Program for Nanoscale Materials.

The full text of all three can be found here.

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