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Monthly Federal Developments Memorandum
December 1, 2010

Monthly Update for December 2010

Bergeson & Campbell, P.C.

FEDERAL ISSUES

Bergeson & Campbell, P.C. extends its best wishes to our clients and many friends and we wish you and your family a happy, healthy, and peaceful New Year.

TSCA/FIFRA/NTP/EPCRA

EPA Denies Second Request Made In TSCA Section 21 Petition Regarding Lead: On November 17, 2010, the U.S. Environmental Protection Agency (EPA) issued its decision to deny the second request made by certain petitioners seeking a ban on lead in fishing sinkers. 75 Fed. Reg. 76246. EPA determined that the petitioners failed to demonstrate that the action requested — a uniform national ban of lead for use in all fishing gear — is necessary to protect against an unreasonable risk of injury to health or the environment, as required by the Toxic Substances Control Act (TSCA). According to EPA, petitioners failed to provide a sufficient basis why a national ban of lead fishing sinkers and other lead fishing tackle is necessary given the actions being taken to address the concerns identified in the petition. The petitioners also, according to EPA, did not demonstrate that the action requested in the petition is the least burdensome alternative adequately to protect against the concerns identified in the petition, as required by TSCA Section 6. On August 3, 2010, several groups filed a petition under TSCA Section 21 requesting that EPA prohibit under TSCA Section 6(a) the manufacture, processing, and distribution in commerce of lead bullets and shot and lead fishing sinkers. On August 27, 2010, EPA denied the request as to lead bullets and shot due to a lack of authority to regulate these materials under TSCA. EPA’s decision was based on the exclusion of shells and cartridges from the definition of “chemical substance” in TSCA Section 3(2)(B)(v).

In a related development, the same coalition of environmental groups filed suit against EPA on November 23, 2010, for its failure to ban the use of lead in hunting ammunition and fishing tackle. See Center for Biological Diversity v. Jackson, D.D.C., No. 10-2297. The coalition claims that EPA has the authority under TSCA to regulate substances, including lead in hunting ammunition and fishing sinkers. The group also claims that EPA’s decision not to use its TSCA Section 6 authority lacks legal merit.

EPA Announces Second List Of Chemicals For EDSP Screening And Publication Of Proposed Policies And Procedures For Requiring EDSP Testing Of The Listed Chemicals: On November 17, 2010, EPA announced the second list of chemicals and substances for which EPA intends to issue test orders under the Endocrine Disruptor Screening Program (EDSP). 75 Fed. Reg. 70248. EPA states that the list of 134 chemicals “includes a large number of pesticides, two perfluorocarbon compounds (PFCs), and three pharmaceuticals (erythromycin, nitroglycerin, and quinoline). This list also consists of an array of other chemicals, ranging from those used for industrial manufacturing processes, as plasticizers, or in the production of pharmaceutical and personal care products (PPCPs).” The 134 chemicals include a significant number of TSCA chemicals that EPA has identified as priorities under the Safe Drinking Water Act (SDWA) and may be found in sources of drinking water where a substantial number of people may be exposed. The list also includes pesticide active ingredients that EPA is evaluating under its Registration Review Program to ensure they meet current scientific and regulatory standards. On December 14, 2010, EPA extended the comment period on the EDSP’s second list of chemicals for Tier 1 screening. 75 Fed. Reg. 77869. The notice extends the comment period from December 17, 2010, to January 18, 2011. The list is available online.

In a separate notice, EPA also announced its draft policies and procedures for requiring Tier 1 screening under the EDSP. 75 Fed. Reg. 70558. EPA states that it drafted the notice “with the intent of explaining the policies and procedures relevant to EDSP SDWA chemicals,” and that the draft policies and procedures are intended to supplement the existing EDSP policies and procedures that EPA published in the Federal Register on April 15, 2009. Comments are due on or before January 18, 2011. More information regarding the draft policies and procedures is available online.

In a third Federal Register notice, EPA announced its plan to request an addendum to an existing Information Collection Request (ICR) to the Office of Management and Budget (OMB). 75 Fed. Reg. 70568. According to the notice, the addendum “simply covers the burden for a new list of chemicals to receive and respond” to EDSP testing orders. EPA is not changing the activities articulated in the original ICR. Comments are due on or before January 18, 2011.

More detailed memoranda are available online here and here.

EPA Issues Final Rule Adding National Toxicology Program Chemicals To Toxics Release Inventory (TRI) Section 313: On November 26, 2010, EPA issued a final rule adding 16 chemicals to the list of toxic chemicals subject to reporting under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) of 1986 and Section 6607 of the Pollution Prevention Act of 1990. 75 Fed. Reg. 72727. The 16 chemicals have been classified by the National Toxicology Program (NTP) in its Report on Carcinogens (RoC) as “reasonably anticipated to be a human carcinogen.” EPA has determined that these 16 chemicals meet the EPCRA Section 313(d)(2)(B) criteria because they can reasonably be anticipated to cause cancer in humans. The final rule was effective November 30, 2010, and applies to the reporting year beginning January 1, 2011 (reports due July 1, 2012). The 16 chemicals are:

Category NameCAS No.
1,6-Dinitropyrene42397-64-8
1,8-Dinitropyrene42397-65-9
6-Nitrochrysene07496-02-8
4-Nitropyrene57835-92-4
1-Amino-2,4-dibromoanthraquinone00081-49-2
2,2-bis(Bromomethyl)-1,3-propanediol003296-90-0
Furan00110-00-9
Glycidol00556-52-5
Isoprene00078-79-5
Methyleugenol00093-15-2
o-Nitroanisole00091-23-6
Nitromethane00075-52-5
Phenolphthalein00077-09-8
Tetrafluoroethylene00116-14-3
Tetranitromethane00509-14-8
Vinyl Fluoride00075-02-5

EPA Announces New Tool To Promote Safer Chemicals And Products: On November 30, 2010, EPA announced new criteria to help companies and other groups, such as states and environmental organizations, identify safer chemicals. As part of the EPA’s Design for the Environment (DfE) program, EPA unveiled the new criteria that, according to EPA, are an important tool under its DfE Alternatives Assessments for identifying safer alternatives to chemicals that pose a concern to human health and the environment. DfE Alternatives Assessments will be conducted for bisphenol A (BPA), phthalates, decabromodiphenyl ether (decaBDE), hexabromocyclododecane (HBCD), and nonylphenol and nonylphenol ethoxylates (NP and NPEs). Both the BPA and decaBDE efforts are under way and include the use of BPA and its alternatives in thermal paper, such as cash register receipts, and the review of flame retardant alternatives to decaBDE in products such as textiles, plastic palettes, and electronics. Assessments of phthalates, the flame retardant HBCD, and NPEs will begin in 2011. According to EPA, the assessments will lead to the manufacture of safer products and reduced chemical exposures. Comments are due by January 31, 2011.

EPA Seeks Comment On Petition To Ban Triclosan: On December 8, 2010, EPA made available for review and public comment a petition submitted by Beyond Pesticides and Food & Water Watch to EPA, asking EPA to use its authority under various statutes to regulate triclosan. 75 Fed. Reg. 76461. Triclosan is an antimicrobial substance used in pesticide products, hand sanitizers, toothpaste, and other consumer products. Petitioners claim that the “pervasive and widespread use” of triclosan poses significant risks to human health and the environment. In addition, the petitioners claim that EPA failed to address the impacts posed by triclosan’s degradation products on human health and the environment, failed to conduct separate assessments for triclosan residues in contaminated drinking water and food, and is complacent in seriously addressing concerns related to antibacterial resistance and endocrine disruption. EPA has established a public docket, which contains a copy of the petition and will contain all comments received in response to the notice. The docket may be accessed as described in this notice. Comments must be received on or before February 7, 2011.

EPA Announces Availability Of Literature Searches For IRIS Assessments: On December 10, 2010, EPA announced the availability of literature searches for four Integrated Risk Information System (IRIS) assessments — acetaldehyde (CAS No. 75-07-0), hexachlorobutadiene (CAS No. 87-68-3), hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX) (CAS No. 121-82-4), and naphthalene (CAS No. 91-20-3) — and requested scientific information on health effects that may result from exposure to these chemical substances. 75 Fed. Reg. 76982. EPA is accepting information related to the specific substances as well as any other compounds being assessed by the IRIS Program.

CAA/CWA

White House Issues Guidance On Use Of Categorical Exclusions For Federal Permits: On November 23, 2010, the White House Council on Environmental Quality (CEQ) released final guidance limiting the use by federal agencies of Clean Water Act (CWA) categorical exclusions. These exclusions allow permits to be issued without environmental impact statements (EIS) for commercial and industrial activities on federal land or in other circumstances requiring federal approval. The guidance called for more rigorous procedures in establishing, applying, and altering categorical exclusions under the authority of the National Environmental Policy Act (NEPA). The guidance notes that all categorical exclusions should be reviewed at least every seven years to assure that they are not becoming outdated. Categorical exclusions generally cover broad categories of similar activities and are common for road repair projects, prescribed burns for forest management, some timber harvests, housing construction, and much onshore oil and natural gas drilling. To establish better-defined limits on a categorical exclusion, the guidance states the text of an exclusion document should clearly specify “any physical, temporal, or environmental factors that would constrain its use.” The CEQ’s final guidance revising the use of categorical exclusions is available online.

EPA Issues Final Rule Mandating Reporting Of Greenhouse Gases (GHG) For Sources Of Fluorinated GHGs: On December 1, 2010, EPA issued a final rule requiring the monitoring and reporting of GHG emissions from additional sources of fluorinated GHGs. 75 Fed. Reg. 74774. The additional sources include electronics manufacturing, fluorinated gas production, electrical equipment use, electrical equipment manufacture or refurbishment, as well as importers and exporters of pre-charged equipment and closed-cell foams. This rule requires monitoring and reporting of GHGs for these source categories only for sources with carbon dioxide equivalent emissions, imports, or exports above certain threshold levels. This rule does not require control of GHGs. The final rule is effective on December 31, 2010.

GREEN CHEMISTRY DEVELOPMENTS

California Prepares For Release Of Final “Safer Consumer Product Alternatives” Regulations: The 15-day comment period regarding the California Department of Toxic Substances Control (CDTSC) November 16, 2010, release of revisions to its “Safer Consumer Product Alternatives” (SCPA) regulations ended on December 3, 2010. The SCPA regulations pertain to the identification and prioritization of chemicals of concern in consumer products, evaluation of their alternatives, and regulatory responses for selected alternatives. CDTSC appears on track, as required under the 2008 law (A.B. 1879), to adopt regulations to address chemicals and chemical ingredients in consumer products by January 1, 2011.

If the revised SCPA regulations are adopted as is, the focus of CDTSC’s efforts for the first five years will be limited to three categories of consumer goods “Priority Products.” Specifically, the revised SCPA regulations would initially limit the types of consumer products that could be classified as “Priority Products” to: (1) children’s products; (2) personal care products; and (3) household cleaning products. After five years (i.e., after January 1, 2016), CDTSC would not be required to limit the scope of Priority Products to these three types of consumer products. It should be noted that there are some exemptions for certain products (e.g., food, pharmaceuticals, medical devices) that will continue to apply. In addition, CDTSC removed all references to nanotechnology and nanomaterials in the revised proposed SCPA regulations.

One of the initial responsibilities of CDTSC would be the creation of a list of “Chemicals of Concern,” which is required to be completed by December 31, 2011, and then the creation of a list of “Priority Products,” which is required to be completed by December 31, 2012. The SCPA regulations provide that in preparing the initial list of Chemicals of Concern, CDTSC “shall only consider chemicals that are one or more of the following”:

  • Chemicals that are carcinogens or reproductive toxins, or both.
  • Chemicals that are listed as Category 1A or 1B mutagens in Annex VI to Regulation (EC) No. 1272/2008 of the European Parliament and the Council.
  • Chemicals that have been determined by EPA to be persistent bioaccumulative toxic chemicals (although this criteria does not apply to any list of Chemicals of Concern issued after the initial list).

The proposed revised SCPA regulations also provide the criteria by which CDTSC shall determine those chemicals “of highest priority.” The regulations provide that CDTSC “shall seek to identify and give priority to those chemicals that pose the greatest threat of adverse public health and environmental impacts, are most prevalently distributed in commerce and contained in products used by consumers, and for which there is the greatest potential for consumers or environmental receptors to be exposed to the chemicals in quantities that can result in adverse public health or environmental impacts.”

CDTSC is required under the proposed revised SCPA regulations to make its initial proposed Chemicals of Concern list available on CDTSC’s website for public review and comment and hold “one or more public workshops to provide an opportunity for the public to comment orally on the proposed list,” before a final list is issued.

To assist CDTSC, the proposed revised SCPA regulations set forth a procedure under which CDTSC could request data or other information concerning chemicals and products. The type of information that could be requested includes:

  • Chemical and product data and information specified in Section 69302.3 (Chemicals of Concern Prioritization) and 69303.3 (Priority Products Prioritization);
  • Available and applicable chemical identification and description information;
  • Information describing the types, categories, and classes of products that contain Chemicals of Concern;
  • Information on intentionally-added chemicals and chemical ingredients in specified products, and quantities of the chemical in the entire product or component;
  • Market presence information;
  • Description of end-of-life management program(s) for a product, if any; and
  • Standard analytical chemical protocols, if available, for the detection and measurement of a chemical in products and in environmental and biological media.

Although CDTSC attempted to clarify and scale back the types and amount of information that parties could be required to submit as part of the information-gathering process that feeds into the identification and prioritization processes for chemicals and products, companies may still face significant burdens and confidentiality protection issues if required to provide the information described above.

The revised regulations and documents added to the rulemaking file are available online.

NANOTECHNOLOGY

EPA Posts Interim Technical Guidance For Assessing Exposure To Nanomaterials: EPA has posted a June 17, 2010, document entitled “Interim Technical Guidance for Assessing Screening Level Environmental Fate and Transport of, and General Population, Consumer, and Environmental Exposure to Nanomaterials.” According to the Interim Guidance, EPA prepared it “to serve as a guide when developing screening level exposure and environmental fate and transport assessments for nanomaterials,” such as those submitted under the TSCA New Chemicals Program. The Interim Guidance is applicable for neat nanomaterials (i.e., powdered or particulate forms), as opposed to nanoscale particles embedded within composites. At this time, according to the Interim Guidance, EPA does not have models or methods capable of predicting the fate of, or exposure to, nanoscale particulates in the environment. This fact, combined with the limited data for nanomaterials, means that there is uncertainty in estimating removal efficiencies, degradation half-lives, partitioning, and transport of nanomaterials. To address the uncertainty, EPA recommends using a conservative bounding “what if” scenario, which assumes that nanomaterials are not removed during wastewater treatment or incineration (i.e., 0 percent removal efficiency), are persistent (i.e., P3), are highly bioaccumulative (i.e., B3), and are highly mobile in groundwater unless measured data are available that proves otherwise. EPA describes this conservative approach as “prudent at this time given the limited available data and lack of historical knowledge regarding the behavior of nanomaterials in the environment.” The Interim Guidance is available online.

Australian Government Reviews Notification Process For Industrial Nanomaterials: The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) recently announced new administrative processes for the notification and assessment of industrial nanomaterials that are considered new chemicals, which will be of interest to companies introducing nanomaterials as new chemicals in Australia. NICNAS is the governmental, industrial chemical notification system in Australia and is responsible for the management of the Australian Inventory of Chemical Substances. After convening consultations between November 2009 and February 2010, NICNAS is now introducing new administrative processes for notifying and assessing industrial nanomaterials that are considered new chemicals under Part 3 of the Industrial Chemicals Notification and Assessment Act 1989. The information was published in the Australian government’s October 5, 2010, Chemical Gazette, which can be viewed online. A more detailed memorandum is available online.

USDA ORACBA Risk Forum Discusses Moving Beyond Nanogeneralities: On November 16, 2010, the United States Department of Agriculture (USDA) Office of Risk-Assessment and Cost-Benefit Analysis (ORACBA) convened a Risk Forum on “Moving Beyond Nanogeneralities — Providing Focus to Nanopolicy Progress.” Presenters included Richard Canady, Ph.D., DABT, Director, Center for Human Health Risk Assessment Research Foundation of the International Life Sciences Institute; Steve Froggett, Expert Consultant, ICF International, Inc; and Guillaume Gruere, International Food Policy Research Institute. The speakers propose that the issues concerning nanotechnology and nanomaterials are so varied, broad, and controversial that they impeded the development of beneficial uses, even where the risks are negligible. The speakers suggest that, early in any discussion or in any risk assessment of nanomaterial uses, the problem selection and problem formulation are critical. If the selection and formulation are done well, regulators and stakeholders can make progress in risk assessment policy and risk management of specific uses of nanomaterials. The slide presentation is available online.

California Removes Nano References In The Revised Safer Consumer Product Alternatives Regulations: On November 16, 2010, the CDTSC released revisions to its safer consumer product alternatives regulations for a 15-day comment period. Of particular note, CDTSC has removed all references to nanotechnology and nanomaterials in the proposed regulations, which previously defined nanomaterials and included “physical, chemical, or quantum properties specific to nanomaterials” on the list of prioritization factors that CDTSC would consider in placing chemicals on the list of Chemicals Under Consideration. The revised proposed regulations also no longer exclude nanomaterials from the de minimis exemption. Under the Green Chemistry Program, the Office of Environmental Health Hazard Assessment (OEHHA) will specify the hazard traits, environmental and toxicological end-points, and other relevant data to include in the state’s Toxics Information Clearinghouse. CDTSC will use information from the clearinghouse to help identify chemicals of concern in consumer products. OEHHA’s pre-regulatory draft regulation includes reference to nanoparticles and defines a “nanomaterial hazard trait.” CDTSC’s revised proposed regulations are available online. OEHHA’s pre-regulatory draft regulation is available online.

ICTA Petitions EPA To Investigate Nano-Copper Pesticides: On November 18, 2010, the International Center for Technology Assessment (ICTA) petitioned EPA to investigate nano-copper pesticides. ICTA, which petitioned EPA in May 2008 to regulate nano-silver and other nano-pesticide products, singles out three registrations obtained by Osmose, Inc. for “micronized” copper carbonate. According to ICTA, “it does not appear that Osmose advised EPA when it applied for these three registrations that any of these products included intentionally produced nanoscale material, but, as explained below, it clearly knew this was the case.” The Office of Pesticide Programs (OPP) has stated that it intends to treat any pesticide products containing nanoscale materials as new products, and ICTA notes that “registrants were also on notice well before 2008 that OPP wanted any applicant requesting registration of a pesticide product containing a nanoscale active ingredient or inert ingredient to disclose that fact during the application process.” ICTA claims that Osmose used the formulator’s exemption to register its products, although it intentionally modified the structure of the purchased active ingredient to create nanoscale particles, which it neglected to tell EPA. ICTA requests that EPA “immediately investigate” the three products, and revoke the registrations, if EPA determines that Osmose registered the products on the basis of an invalid claim. ICTA also requests that EPA “thoroughly investigate other possible nanoscale copper products, which should include but not be limited to copper-based wood treatment products currently available on the market, as similar actions under FIFRA may be necessary.” ICTA’s petition is available online.

EPA Submits Proposed TSCA Section 8(a) Reporting Rule For Nanoscale Materials To OMB For Review: On November 22, 2010, EPA submitted a proposed Section 8(a) TSCA reporting rule to OMB for review. According to EPA’s April 26, 2010, Regulatory Agenda, the proposed rule would require that persons who manufacture nanoscale materials notify EPA of certain information, including available use, production volume, methods of manufacture and processing, exposure and release information, and available toxicity data pertinent to existing nanoscale materials. EPA states that the proposed reporting of these activities will provide it with an opportunity to evaluate the information and consider appropriate action under TSCA to reduce any risk to human health or the environment.

EPA OIG Focusing On Nanomaterials And Other Substances: On November 23, 2010, EPA’s Office of Inspector General (OIG) reported that it is focusing on a number of topics in the pesticide and chemical arena, including EPA’s approach to nanomaterials, the EDSP, and control of confidential business information outside of EPA. OIG’s fiscal 2011 annual plan identifies mandated and selected OIG assignments that are continuing from fiscal 2010 into fiscal 2011, along with new assignments slated for fiscal 2011, and the multiple reasons for OIG’s focus on particular topics. Carryover assignments from fiscal 2010 in this area include: EPA’s EDSP for Assessing Endocrine-related Health Risks; use of Remote Sensing Data to Assess Environmental Contamination at Selected De-listed Superfund Sites; and EPA’s approach to nanomaterials. Among the new assignments planned for fiscal 2011 in this area are: EPA’s Voluntary Children’s Chemical Evaluation Program; penalties for FIFRA and TSCA violations; and effectiveness of Strategies and Plans for Implementing Controls at Superfund Sites.

EPA Seeks Comments On Public Information Exchanges On EPA Nanomaterial Case Studies: On December 13, 2010, EPA announced a public meeting to receive comments and questions on the EPA Nanomaterial Case Studies (see online; see online). 75 Fed. Reg. 77636. The meeting will also afford EPA an opportunity to highlight the Nanomaterial Case Studies and how they are being used as part of an ongoing process to refine a long-term research strategy to support the comprehensive environmental assessment of nanomaterials. The Public Information Exchange Meeting on the EPA Nanomaterial Case Studies will be held on January 4, 2011, beginning at 12:30 p.m. and ending no later than 3:30 p.m. Eastern Standard Time. Written comments should be submitted to EPA by December 28, 2010.

NIOSH Seeks Comment On Draft CIB Concerning Occupational Exposure To Carbon Nanotubes And Nanofibers: The National Institute for Occupational Safety and Health (NIOSH) released a draft Current Intelligence Bulletin (CIB) entitled Occupational Exposure to Carbon Nanotubes and Nanofibers, which recommends that, until results from research studies can fully elucidate the physicochemical properties of carbon nanotubes (CNT) and carbon nanofibers (CNF) that define their inhalation toxicity, employers should take steps to minimize CNT and CNF exposures of all workers and implement an occupational health surveillance program that includes elements of hazard and medical surveillance. The draft CIB includes more specific recommendations for employers and workers to minimize potential health risks associated with exposure to CNT and CNF. NIOSH will hold a public meeting on the draft CIB on February 3, 2011, in Cincinnati, Ohio. According to NIOSH, during the meeting, it will place special emphasis on:

  • Whether the hazard identification, risk estimation, and discussion of health effects for carbon nanotubes and nanofibers are a reasonable reflection of the current understanding of the evidence in the scientific literature;
  • Workplaces and occupations where exposure to carbon nanotubes and nanofibers occur;
  • Current strategies for controlling occupational exposure to carbon nanotubes and nanofibers (e.g., engineering controls, work practices, personal protective equipment);
  • Current exposure measurement methods and challenges in measuring workplace exposures to carbon nanotubes and nanofibers; and
  • Areas for future collaborative efforts (e.g., research, communication, development of exposure measurement and control strategies).

Notification of intent to attend the meeting is due to NIOSH on January 28, 2011. Comments on the draft CIB are due February 18, 2011. More information is available online.

NanoBusiness Alliance Interviews Lynn L. Bergeson: NanoBusiness Alliance included Lynn L. Bergeson in its recent interview series. The interview covers a wide range of issues related to nanotech environmental, health and safety, including uch “hot” topics as establishing a nano nomenclature that is uniform, thoughtful, and useful for regulatory purposes; EPA’s three TSCA proposals that will have an immediate and significant impact on the commercialization of nanoscale materials; and the EPA’s OPP development of a policy under FIFRA that will apply to nanopesticides. The NanoBusiness Alliance is an industry association founded to advance the emerging business of nanotechnology and microsystems for corporations, start-ups, researchers, universities, investors, and a host of other key stakeholders. The Alliance’s mission is to create a collective voice for the emerging small-tech industry and develop a range of initiatives to support and strengthen the nanotechnology business community, through public policy efforts, events, research, and the creation of partnerships. The interview is available online.

EP Approves RoHS Recast: On November 24, 2010, the EP overwhelmingly approved the proposed recast of the Restriction of Hazardous Substances (RoHS) Directive, which restricts the use of certain hazardous substances in electronic and electrical equipment (EEE). The EP passed by a vote of 640 to 3, with 12 abstentions, legislation that would extend the Directive to most EEE, unless specifically excluded. The legislation calls for a review of the Directive after three years, at which time new substances may be added. Exemptions for banned substances would be allowed only if they are in the interest of consumer health and safety and no alternatives are available. Proposed restrictions on additional substances, including nanosilver and long multi-walled carbon nanotubes, were not supported by the EU Council and are not included in the version of the legislation passed by both the EU Council and EP. The EP press release notes that “nanomaterials are cited as due for further scientific scrutiny” when RoHS is reviewed in three years. More information is available online.

OECD Posts New And Revised Publications In The Series On The Safety Of Manufactured Nanomaterials: On December 3, 2010, the Organization for Economic Cooperation and Development (OECD) posted two documents in its series on the safety of manufactured nanomaterials:

  • Compilation and Comparison of Guidelines Related to Exposure to Nanomaterials in Laboratories — OECD developed this document as part of its work on occupational exposure mitigation. The document compares existing published guidelines regarding the use of nanomaterials at the laboratory scale, including the manufacture and the use of products in industrial, institutional, and commercial settings. OECD states: “Since there are not globally standardized protection measures determined for nanomaterials, it is expected that this document is to be of interest for research laboratories and industrial enterprises that produce or process nanomaterials at the laboratory scale.” The document is available online.
  • List of Manufactured Nanomaterials and List of Endpoints for Phase One of the Sponsorship Programme for the Testing of Manufactured Nanomaterials: Revision — OECD first published this document in 2008. It provides the list of representative manufactured nanomaterials and the list of endpoints for human health and environmental safety addressed by the Sponsorship Programme for the Testing of Manufactured Nanomaterials. OECD states that, based on the current state of knowledge, the Working Party on Manufactured Nanomaterials updated the list of manufactured nanomaterials by removing carbon black and polystyrene, and adding gold-nanoparticles. The document is available online.

Draft NNI EHS Research Strategy Available For Comment: The White House Office of Science and Technology Policy (OSTP) and the Nanoscale Science, Engineering, and Technology Subcommittee of the National Science and Technology Council request comments regarding the draft National Nanotechnology Initiative 2011 Environmental, Health, and Safety Research Strategy. The draft Strategy describes the National Nanotechnology Initiative’s (NNI) environmental, health, and safety (EHS) vision and mission, the state of the science, and the research needed to achieve the vision. It represents the consensus of the participating agencies on how to promote the responsible development of nanotechnology by providing guidance to federal agencies as they develop their agency-specific research priorities, strategies, and implementation plans to achieve this vision. It describes the goals and research needs for five science topics that shape EHS research (nanomaterial measurement infrastructure, human exposure assessment, human health, environment, and risk assessment and risk management methods), and evaluates the state of the science for each of these topics. The draft Strategy also includes an analysis of the fiscal year 2009 federal EHS research portfolio and identifies concepts and approaches to accelerate the pace of research in this crucial area. The 2011 plan will update and replace the 2008 NNI EHS Research Strategy. Comments are due January 6, 2011.

EPA Claims Company Made Illegal Public Health Claims For Nano Silver Product: On December 15, 2010, EPA announced that it fined Kinetic Solutions Inc., doing business as Rabbit Air, $82,400 for allegedly selling unregistered and misbranded pesticides and making unproven claims about their effectiveness. According to EPA, Kinetic Solutions Inc. made illegal public health claims for its air purifier branded “Nano Silver Pre Filter” and the filter’s ability to control over 650 types of bacteria, a violation of FIFRA. In addition, its air purifiers did not list a valid EPA Establishment Number on the packaging, a federal requirement that helps regulators keep track of where pesticides and devices are produced. EPA states that the violations were discovered through an online search and subsequent inspection by the California Department of Pesticide Regulation. According to Kinetic Solutions Inc., the Nano Silver Pre Filter incorporates a substance called “nano silver” or “silver nano ions,” a substance or mixture of substances intended to prevent, destroy, repel, or mitigate bacteria and mold. Products that kill or repel bacteria or germs are considered pesticides, and must be registered with the EPA prior to distribution or sale. According to EPA, the Nano Silver Pre Filter is a pesticide and was not registered as such as required by federal law.

REACH DEVELOPMENTS

REACH Registration Passes: November 30, 2010, marked the deadline for the registration of high volume chemicals under the Registration, Evaluation, Authorization and Restriction of Chemicals Regulation (EC 1907/2006) (REACH). The European Chemicals Agency (ECHA) reported recently that it had received 24,675 registration dossiers, submitted for nearly 3,400 phase-in substances. The final number of registrations and substances will be available when all submitted dossiers have been processed within the coming weeks. Registrations were received from all member states, the highest percentage being from Germany at 23%, almost double the 12% received from the United Kingdom, which submitted the second highest number of registrations. The number of registrations accepted for processing is in line with what was originally forecast by the EC. The numbers of registrations increased steadily throughout the year, but from September 2010, the trend changed. Numbers increased with incoming registrations in a single month totaled four times the number of dossiers previously registered. In the last six months, the ECHA Helpdesk reportedly addressed in excess of 5,500 inquiries. Of these, 27% were minor technical issues concerning REACH-IT that were easily resolved. A further 22% concerned more complex submission activities such as, for example, data sharing, invoicing, and business rules. During 2010, ECHA has also provided a series of training sessions and 16 webinars, which attracted over 10,000 participants. Finally, during the last quarter, ECHA was contacted by more than 500 companies (30% of them Small- and Medium-sized Enterprises (SME)) by phone or e-mail to help with their specific submission problems. As a result of this and the availability of specific IT tools to pre-check the content of the dossiers, the success rates of submitted dossiers increased steadily. During 2010, the Directors Contact Group identified 28 different scenarios in which companies might face impediments to registration and measures to help such companies were set up. A total of 17 such cases were submitted to ECHA by the deadline. ECHA received registrations for nearly 400 substances which are listed as Category 1 carcinogens, mutagens, or reprotoxins and more than 150 as R50-532 from Annex VI of the Classification, Labelling, and Packaging (CLP) regulation. Of those, 27 are already on the Candidate List of Substances of Very High Concern (SVHC).

ECHA Adds Eight Chemicals To SVHC List And Eight Other Chemicals To REACH Authorization List: On December 3, 2010, ECHA’s Member State Committee made a final decision to add eight substances to the SVHC list. The substances are: chromium trioxide; acids generated from chromium trioxide and their oligomers; cobalt (II) sulphate; cobalt (II) dinitrate; cobalt (II) carbonate; cobalt (II) diacetate; 2-methoxyethanol; and 2-ethoxyethanol. Also on December 3, ECHA’s Member State Committee adopted ECHA’s draft recommendation on the addition of these other substances to the REACH Annex XIV Authorization list, meaning that these chemicals will now be considered by the EC for final decision and placement on the list of chemicals that require REACH Authorization. The chemicals that will be controlled under REACH Authorization without exemption are as follows: di-isobutylphthalate (DIBP); diarsenic trioxide; diarsenic pentaoxide; lead chromate; lead sulfochromate yellow (C.I. Pigment Yellow 34); lead chromate molybdate sulphate red (C.I. Pigment Red 104); tris (2-chloroethyl) phosphate (TCEP); and 2,4-dinitrotoluene (2,4-DNT). Revisions to both the SVHC list and the Authorization list to reflect these added chemicals are expected in the next few weeks. More information is available online.

ECHA Publishes First List Of Registered Substances: On December 10, 2010, ECHA published the first list of substances registered under REACH. As of December 7, the number of publishable phase-in substances registered was 2,992 — a further 207 substances covered by confidentiality claims exist, taking the total number of registered phase-in substances to 3,199. The list, which will be updated weekly, can be compared to the list of substances ECHA was informed would be registered by the November 30, 2010 deadline — this suggested 4,900 substances would be covered. ECHA has also updated its weekly statistics showing registrations and classification and labelling (C&L) notifications. While C&L notification rose to 1.4 million last week, Geert Dancet, Executive Director of ECHA, told Chemical Watch in a post-registration deadline interview that there is some concern as the number of C&L notifications is lower than expected and the January 3, 2011, deadline still presented a huge challenge. ECHA has announced extended operating hours for REACH-IT to accept C&L notifications and its Helpdesk over the Christmas and New Year holiday period.

Chemical Watch also understands that a number of registration dossiers were received after the deadline. While ECHA would not confirm this, it stated: “We will observe what came and comes in after the deadline and take a decision based on the actual situation.” While it will continue to process all dossiers submitted, it still has to decide what action to take in terms of informing enforcement authorities if the dossiers should have been in before December 1, 2010.

Meanwhile, Bjorn Hansen, Deputy Head of the EC’s unit for chemicals, pesticides, and nanomaterials, speaking at the European Chemical Industry Council (CEFIC) REACH implementation workshop earlier this week, revealed that the REACH Directors’ Contact Group (DCG) decided at a meeting at the end of November to cancel an emergency meeting that had been planned for December 8 based on ECHA data that indicated there were no major issues relating to registration.

Hansen also noted that the DCG is currently discussing its future role and expects to come to a conclusion in January. Hansen stated there were a number of things to consider: “It was an emergency group — it was small so that it could identify [problems] and react quickly. But in the future its work will be more programmed.” Hansen believed the group should still remain relatively small so that it can maintain its efficiency. “But it will continue, it is clear,” he added.

At the same meeting, ECHA’s Christel Musset, who is in charge of registration and IT tools, said that it was a relief the deadline was over and ECHA was pleased with what happened. Musset said key to the success was ECHA’s very constructive relationship with industry and the work of the DCG.

Musset said ECHA was already working on the next deadline with industry and EU Member States. Musset stated ECHA hoped to further develop IUCLID to enable it to be used more effectively; she also said that in 2011 ECHA plans to improve the user interface with REACH-IT.

LEGISLATIVE DEVELOPMENTS

House Republican Leadership Elected: On December 7, 2010, the House Republican Steering Committee picked Rep. Fred Upton (R-MI) to lead the Energy and Commerce Committee and Rep. Harold Rogers (R-KN) to chair the House Appropriations Committee. Final approval by the full party membership occurred on December 8, 2010. The Committee also named Rep. John Mica (R-FL) as the Chairman of the House Transportation and Infrastructure Committee, which has jurisdiction over various CWA and SDWA programs. The 30-member Steering Committee, headed by Republican Minority Leader John Boehner (R-OH), the presumptive speaker of the House, made its selections for Committee Chairmen in the next Congress during a two-hour, closed-door meeting in the Capitol.

Major Food Safety Overhaul Stalled By Appropriations Debate: The “FDA Food Safety Modernization Act.” has been voted on and approved by both Houses of Congress, but final passage must await resolution of broad appropriation issues. The present situation came about after the Senate approved the measure by a vote of 73-25.and sent it to the House of Representatives. An issue was raised at that point that one provision of the bill might be unconstitutional, since the Senate had voted for the imposition of fees for such as things as needed re-inspections and the costs of monitoring compliance with recall orders. Those fees are considered revenue producing measures, the argument goes, and can only originate in the House. The House modified the Senate bill to make it clear the House was authorizing the fees, and the House passed the bill by a vote of 212 to 206. The close vote was primarily because the food safety measure was incorporated into a full year continuing appropriations measure, a stop-gap to keep Government agencies running into the new year when the next Congress would take up the needed appropriations. While the Food Safety bill will likely pass, it is not possible at this point to predict exactly when that will occur, since there are differing provisions in Senate and House stop-gap appropriations measures that must be reconciled.

The FDA Food Safety Modernization Act is a major revision of the law governing regulation of food and related subjects, and a major expansion of the authority of the Food and Drug Administration (FDA) to enforce those provisions. In broad terms, the measure amends the Federal Food, Drug and Cosmetic Act (FFDCA) to improve the capacity of the FDA: (1) to prevent food safety problems; (2) to detect and respond to such problems when they do occur; and (3) to improve the safety of foreign foods imported into the U.S. Among the problems highlighted during discussion of the legislation were salmonella in eggs, and peanuts and issues with coolie dough, spinach, and Jalapeños.

The prevention of food safety problems is intended to be accomplished in a variety of ways in the legislation. A cornerstone of the legislation is the authority given to FDA to inspect records related to food, including records of food that the FDA reasonably believes is likely to be affected in a similar manner as an adulterated food. Under the Food Safety measure, each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports an article of food must permit inspection of his or her records if the Secretary believes that there is a reasonable probability that the use of or exposure to such food will cause serious adverse health consequences or death. If the FDA makes such a finding, it can act to suspend the registration of a food facility. Another important cog in the steps to prevent food safety problems is the expansion of the previously limited authority to require producers to conduct hazardous analyses of food. S. 510 requires each owner, operator, or agent in charge of a food facility to: (1) evaluate the hazards that could affect food; (2) identify and implement preventive controls; (3) monitor the performance of those controls; and (4) maintain records of such monitoring. The legislation directs the Secretary to promulgate regulations to establish science-based minimum standards for conducting the requisite hazard analysis, documenting hazards, implementing preventive controls, and documenting such implementation. The bill as passed includes other directives to the executive branch. FDA is to (1) review and evaluate relevant health data and other information to determine the most significant food-borne contaminants; and (2) issue contaminant-specific and science-based guidance documents, action levels, or regulations. The Secretary must also promulgate regulations to protect against the intentional adulteration of food and establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables that are raw agricultural commodities to minimize the risk of serious adverse health consequences or death. Updated good agricultural practices and guidance for the safe production and harvesting of specific types of fresh produce should also be developed to further prevent food safety problems. The measure directs FDA to assess and collect fees related to: (1) food facility reinspection; (2) food recalls; (3) the voluntary qualified importer program; and (4) importer reinspection, and prohibits the operation of a facility that manufactures, processes, packs, or holds food for sale in the U.S. if the owner, operator, or agent in charge of such facility is not in compliance with the aforementioned sections of the new law.

With respect to the capacity to detect and respond to food safety problems, S. 510 requires FDA to allocate resources to (1) inspect facilities and articles of food imported into the U.S. based on their risk profiles; (2) increase the frequency of inspection of all facilities; and (3) report to the appropriate Congressional Committees annually on food facility and food import inspections. Laboratories for testing are to be identified in a registry to be used to test suspect food and to develop an emergency food network response capability. Provisions are included in the bill to cover tracking and tracing of raw and processed food. FDA is to improve tracking and tracing of fruits and vegetables that are raw agricultural commodities in the event of a food-borne illness outbreak; and (2) establish standards for the type of information, format, and timeframe for persons to submit records to aid the Secretary in such tracking and tracing. FDA is to establish a pilot project to explore and evaluate methods for rapidly and effectively tracking and tracing processed food so that it may quickly identify the source of an outbreak involving such a processed food and the recipients of the contaminated food. Regarding persons that are implicated in food safety problems, FDA is given the power to provide a responsible party with an opportunity to cease distribution and recall an adulterated or misbranded article of food if the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals; and then order said party to immediately cease distribution and provide notice to relevant persons if the responsible party does not voluntarily cease distribution of or recall such article of food. FDA can order a recall if it determines that removal of the article from commerce is necessary, but only after providing an opportunity for a hearing. The standard for the administrative detention of food is revised to allow such a detention if the FDA has reason to believe that such article is adulterated or misbranded.

Concerning the safety of imported food, the FDA is given new powers and directed to expand cooperation with governments in countries where parties are importing food to the U.S. FDA will be able to require U.S. importers to perform risk-based foreign supplier verification activities to verify that imported food is produced in compliance with applicable requirements related to hazard analysis and standards for produce safety and is not adulterated or misbranded. FDA is to issue guidance to assist U.S. importers in developing such foreign supplier verification programs. As an incentive, FDA is to develop an expedited program for food offered for importation by U.S. importers who have voluntarily agreed to participate in the aforesaid verification programs. Food will be refused admission if it fails to comply with requirements developed by FDA as a part of the verification program, or if the entity in question fails to provide a certification or other assurances that the article of food complies with applicable FFDCA requirements. As a further check, FDA is directed to require, prior to importation of an article of food, notice of any country to which such article has been refused entry.

Relations with foreign governments are spelled out in a variety of ways in the Food Safety Modernization Act. FDA has to determine whether a country can provide reasonable assurances that the food supply of the country meets or exceeds the safety of food manufactured, processed, packed, or held in the U.S., and if it does not, FDA is to develop a comprehensive plan to expand the technical, scientific, and regulatory capacity of foreign governments and food industries from which foods are exported to the U.S. Increased inspections are a prominent feature of the bill. FDA is to enter into arrangements and agreements with foreign governments to facilitate the inspection of registered foreign facilities, and FDA is required to direct resources to inspections of foreign facilities, supplies, and food types to help ensure the safety and security of the U.S. food supply. Food is to be refused admission into the U.S. if permission to inspect the food facility is denied by the facility owner, operator, or agent or the foreign country. The recent expansion of FDA presence into foreign countries is recognized and endorsed by a provision requiring FDA to establish offices in foreign countries to provide assistance to the appropriate governmental entities with respect to measures to provide for the safety of articles of food and other products regulated by the FDA that are exported by such countries to the U.S.

As a matter of international relations, S. 510 declares that nothing in this Act shall be construed in a manner inconsistent with the agreement establishing the World Trade Organization or any other treaty or international agreement to which the U.S. is a party.

The Food Safety Modernization Act has been controversial in part because of the perceived effect it would have on small, family owned and operated farms. Those fears were alleviated by virtue of an amendment offered by Senator Jon Tester (D-MT). His amendment provides that food producers are not subject to the requirements in the food safety measure if they sell the majority of their food directly to consumers within the state, or within a 275-mile radius of where it is produced, and if the sales of such producers are less than $500,000.00.

MISCELLANEOUS

President Obama Calls For More Electronics Recycling, Task Force To Encourage Federal Agencies: On November 16, 2010, the Obama Administration announced the formation of a federal task force to promote recycling of electronic waste at federal agencies. EPA’s announcement stated that the CEQ, the General Services Administration, and EPA formed the task force under the Executive Order on Federal Sustainability, Executive Order No. 13,514, signed October 5, 2009. The Presidential proclamation is available online.

ATSDR Makes Tox Profiles Available: On November 22, 2010, the Agency for Toxic Substances and Disease Registry (ATSDR) announced the availability of the Toxicological Profile for Toxaphene (Update) and the Toxicological Profile for Trichlorobenzenes for review and comment. 75 Fed. Reg. 71132. ATSDR seeks comment on the profile. Comments on these draft toxicological profiles must be received not later than February 25, 2011.

EPA Launches Website To Increase Transparency Of Regulatory Activity: On December 3, 2010, EPA launched a new website called Reg Stat that is intended to enhance the public’s understanding of EPA’s regulatory process, a goal to which we all aspire, and the number, type, and range of regulatory documents developed each year by EPA. This new resource is part of EPA’s efforts to enhance the accessibility and transparency of its regulatory activities. Reg Stat provides information on EPA documents published in the Federal Register between 2005 and 2009. It also provides information on rulemakings likely to be of most interest to stakeholders — those rules signed by the EPA Administrator that substantively amend the Code of Federal Regulations. Users will be able to determine the number of rules signed by the Administrator, how long it took to develop each rule, whether a rule underwent Executive Order 12866 regulatory review by OMB, and the length of OMB review. Both summary graphics and searchable data tables are available. An analysis of the data featured on Reg Stat shows that EPA publishes 1,700 to 1,900 documents in the Federal Register each year, a statistic the new Republication House may find interesting and noteworthy. Approximately 7%, or about 100, of those documents are rules that amend the Code of Federal Regulations and require the Administrator’s signature; the average time to publish these rules is 974 days. Users will be able to download and sort the data based on categories of interest. Information on Reg Stat will be updated annually. More information on Reg Stat is available online.

CPSC Promulgates Final Rule Regarding Publicly Available Consumer Product Safety Information Database: On December 9, 2010, the U.S. Consumer Product Safety Commission (CPSC) promulgated the final rule establishing a publicly available consumer product safety information database, as required by Section 212 of the Consumer Product Safety Improvement Act of 2008 (CPSIA). The database must be publicly available, searchable, and accessible through CPSC’s website. CPSC’s final rule interprets various statutory requirements pertaining to the information to include in the database, and establishes provisions regarding submitting reports of harm; providing notice of reports of harm to manufacturers; publishing reports of harm and manufacturer comments in the database; and dealing with confidential and materially inaccurate information. The final rule is effective January 10, 2011. According to CPSC’s website, it will launch the database on March 11, 2011. More information regarding the database is available online. A more detailed memorandum is available online.

Korea Publishes List Of Potential GHS Classifications And Plans To Issue New Material Safety Data Sheet Rules: Korea has taken a major step toward achieving full compliance with the United Nations Globally Harmonized System (GHS) for the classification and labeling of chemicals by identifying 151 substances as “hazardous” for consultation. The Ministry of the Environment (MoE) in Korea also is placing more responsibilities on manufacturers and importers by introducing new rules regarding updating and content of material safety data sheets (MSDS). The MoE has given companies just ten days to comment on the proposed classifications before these classifications are issued in final, or until December 17, 2010.

The MoE has provided a list of the substances together with each proposed classification on its website that includes a description of the methodology used and a list of the evidence for each proposed classification along with a way to provide feedback via e-mail to the MoE. Please note, however, that the website is in Korean and an English translation is not currently available. The website is located at the following address: http://ncis.nier.go.kr/ghs/. A more detailed memorandum is available online.

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