Monthly Update for January 2011
2011 Predictions For EPA’s Office Of Chemical Safety And Pollution Prevention: Bergeson & Campbell, P.C.’s (B&C) thoughts on what may be headed our way in 2011 from the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) are provided in a memorandum available online. In short, the general trends established by the Obama Administration during the past two years are expected to continue notwithstanding the 2010 election results. At the same time, the impact of the election results, notably with the new Republican majority in the House of Representatives, will have a large but uncertain impact on the operations of OCSPP and all other EPA media programs.
B&C And Its Consulting Affiliates Announce The Launch Of B&C’s Consortia Management Affiliate, B&C Consortia Management, L.L.C.: B&C, The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce the formation and launch of B&C’s consortia management affiliate, B&C Consortia Management, L.L.C. (BCCM). BCCM provides core support services for industrial, agricultural, and biocide chemical advocacy, testing, and research consortia. BCCM provides a full compliment of consortia management services, including consortia formation, full financial services managed by a C.P.A., organizational support, administration services, and infrastructure/communication platforms to ensure consortium participants have secure access to consortia documents and operations wherever they may happen to be located. BCCM also provides effective and efficient laboratory communication and management services for consortia that expend significant resources on study data production.
BCCM structures and manages its consortia to conform with the realities of the industrial and agricultural chemical business communities, and offers a variety of state-of-the-art actual and/or virtual electronic platforms or a combination of the two to ensure consortia participants have a business organizational model that allows seamless access to and communication with the consortia and its business affairs. These services free time for consortium members to focus on substantive issues, thus helping to ensure the consortium’s interests are protected and its voice heard on a wide-range of domestic and international regulatory, scientific, legal, and related issues.
B&C, BCCM, Acta, and Acta EU lawyer and non-lawyer scientists and professionals assist clients with addressing the complex legal, regulatory, and science issues that arise at the intersection of law and science policy pertinent to traditional and nanoscale industrial, agricultural chemicals, and biocides. B&C, BCCM, Acta, and Acta EU professionals offer expertise on a full range of global chemical program consulting services that include, but are not limited to, the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the European Union’s (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, the Restriction of Hazardous Substances (RoHS), Globally Harmonized Systems (GHS), and related global chemical regulatory programs in North America, the EU, and Asia and Pacific Rim countries.
BCCM Working With BASF To Create Consortium To Respond To CDTSC DCI: BCCM is working with BASF Corporation (BASF) to create a consortium to provide the California Department of Toxic Substances Control (CDTSC) information on analytical methods that could be used to measure certain nanoscale materials in air, surface water, and soil. The collaborative project will involve adapting known methods used to measure these substances in other media to the analysis of environmental media. The term of the consortium will be at least two years, which can be modified by mutual agreement. On December 21, 2010, CDTSC issued a data call-in (DCI) for information regarding analytical test methods, and other relevant information, from manufacturers of nanosilver, nano zero valent iron, nano titanium dioxide, nano zinc oxide, nano cerium oxide, and quantum dots. Experts within BASF will address issues concerning titanium dioxide and zinc oxide. BASF and BCCM seek other companies and experts to offer similar expertise for the remaining nanomaterials of interest and provide CDTSC with the help it needs. More information is available by e-mailing RDavid@nanoDCI.com.
EPA Issues TSCA Section 4 Test Rule For 19 Chemicals: On January 7, 2011, EPA issued a final rule under TSCA Section 4 requiring manufacturers of 19 high production volume (HPV) chemicals to test the health and environmental effects of the chemicals and submit the data to EPA. 76 Fed. Reg. 1067. The rule is one of a series of actions that EPA is taking to ensure that EPA has the data it needs to review priority chemicals. HPV chemicals are produced in or imported into the United States in quantities of 1 million pounds or more per year. The rule follows up on the voluntary HPV Challenge Program Chemical List launched by EPA that included chemicals used in household products such as hobby/craft glues, personal care products, home cleaning products, home maintenance products, and automotive products. The program challenged companies to make health and environmental effects data publicly available for HPV chemicals. Companies voluntarily supplied data on more than 2,200 HPV chemicals under the challenge program, however, no health and environmental effects data were provided on the 19 chemicals in the rule, making it necessary for EPA to require testing. In the coming year, EPA intends to require testing of other chemicals for which EPA has not received data. The 19 chemicals are:
|1,3-Propanediol, 2,2-bis[(nitrooxy)methyl]-, dinitrate (ester)
|2,4-Hexadienoic acid, (E,E)-
|Methanesulfinic acid, hydroxy-, monosodium salt
|Phosphorochloridothioic acid, O,O-diethyl ester
|D-erythro-Hex-2-enonic acid, g-lactone, monosodium salt
|D-gluco-Heptonic acid, monosodium salt, (2.xi.)-
|C.I. Leuco Sulphur Black 1
|Castor oil, sulfated, sodium salt
|Castor oil, oxidized
|Alkenes, C12–24, chloro
|Hydrocarbons, C > 4
The final rule is effective February 7, 2011. More information on HPV chemicals is available online.
EPA Analysis Shows Reduction In 2009 Toxics Release Inventory Chemical Releases: EPA released in mid-December its annual national analysis of the Toxics Release Inventory (TRI). In 2009, 3.37 billion pounds of toxic chemicals were released into the environment, a 12 percent decrease from 2008. TRI was recently recognized by the Aspen Institute as one of the ten major ways that EPA has strengthened America. EPA provided additional information to make the TRI data more accessible. The TRI analysis now highlights toxic disposals and releases to large aquatic ecosystems, selected urban communities, and tribal lands. In addition, portions of the analysis are available in Spanish for the first time.
The analysis, which includes data on approximately 650 chemicals from more than 20,000 facilities, found that total releases to air decreased 20 percent since 2008, while releases to surface water decreased 18 percent. Releases to land decreased 4 percent since 2008. The analysis shows decreases in the releases of persistent, bioaccumulative, and toxic chemicals, including lead, dioxin, and mercury. Total disposal or other releases of mercury decreased 3 percent since 2008, while total disposal or other releases of both dioxin and lead decreased by 18 percent. The analysis also shows a 7 percent decrease in the number of facilities reporting to TRI from the previous year, continuing a trend from the past few years. According to EPA, some of this decline may be attributed to the economic downturn. Importantly, EPA stated that it intends to investigate why some facilities reported in 2008 but not 2009. EPA added 16 chemicals to the TRI list of reportable chemicals in November. These chemicals are reasonably anticipated to be human carcinogens, and represent the largest chemical expansion of the program in a decade. Data on the new TRI chemicals will be reported by facilities on July 1, 2012. Facilities must report their chemical disposals and releases by July 1 of each year. This year, EPA made the 2009 preliminary TRI dataset available in July, the same month as the data were collected. More information on the 2009 TRI analysis is available online.
EPA And European Chemicals Agency Sign Agreement To Enhance Chemical Safety: In December, EPA and the European Chemicals Agency (ECHA) announced a partnership intended to promote enhanced technical cooperation on chemical management activities. The partnership is part of EPA’s commitment to improve chemical safety. ECHA is the agency that implements the EU’s chemical management program, REACH. The partnership was formalized through a statement of intent and was highlighted at the U.S. Department of State’s Transatlantic Economic Council (TEC) meeting in Washington, D.C. The TEC, established to advance transatlantic economic integration between the United States and the EU, issued a statement stressing the importance for enhanced cooperation on chemicals. The statement establishes a process for working together on a range of issues of mutual interest, including toxicity testing, the hazard and risk assessment of chemicals, risk management tools, scientific collaboration, and information exchange. One of the major anticipated areas of collaboration will be on the exchange of data and information. For example, the statement of intent will promote the exchange of non-confidential information on hazards, uses, and substance identification between ECHA and EPA, including data collected under REACH. The two agencies will also share criteria for managing confidential business information with the goal to increase the availability of chemical information to the public. More information is available online.
EPA Issues Sixty-Seventh Report Of The TSCA Interagency Testing Committee To The Administrator: On December 22, 2010, the TSCA Interagency Testing Committee (ITC) announced that it transmitted its Sixty-Seventh Report to the Administrator of EPA on November 9, 2010. 75 Fed. Reg. 80666. In the 67th ITC Report, the ITC is not making any changes to the TSCA Section 4(e) Priority Testing List. Comments must be received on or before January 21, 2011.
EPA Proposes System To Distribute Pesticide Labels: On December 29, 2010, EPA proposed its long-awaited system to update and distribute pesticide labels via the Internet. 75 Fed. Reg. 82011. EPA’s proposal describes the types of information that would be required to be on labels attached to pesticide containers. The information would include the “released for shipment date” that would detail approved uses of the pesticide when the product was released to the market. The new system must ensure that users do not continue to follow old labeling when using new products. Comment is due by March 29, 2011.
EPA Seeks Comment On Petition For Rulemaking To Establish Procedures Consistent With The Endangered Species Act: On December 22, 2010, EPA announced the availability of a September 16, 2010, petition from Growers for ESA Transparency (GET). 75 Fed. Reg. 80492. GET is a coalition of growers throughout the western United States. GET claims to be committed to improving the consultation process for, the transparency of, and accessibility to the Endangered Species Act (ESA). GET is requesting EPA to take immediate action to establish, by rulemaking, clear and equitable procedures for notice and comment on EPA’s pesticide effects determinations for endangered species and subsequent actions, including draft biological opinions and potential product restrictions consistent with Section 1010 of the 1988 amendments to the ESA. The petition is similar to the petition filed on January 19, 2010, by DOW AgroSciences LLC, Makhteshim Agan of North America, and Cheminova, Inc. USA requesting EPA to promulgate a rule for amending Endangered Species Protection Bulletins (EPA-HQ-OPP-2010-0474). Comments must be received on or before February 22, 2011.
EPA Provides Public With Enhanced Access To Chemical Information: On December 22, 2010, EPA introduced a new web-based tool that is intended to enable the public to search for and have greater access to health and safety studies on industrial chemicals. The tool allows users to conduct a chemical-specific search for health and safety studies that have been submitted to EPA under TSCA. The tool will also be added to Data.Gov, a website developed by the Obama Administration to provide public access to important government information. In addition to making the health and safety studies more accessible, EPA claims to be taking aggressive action to reduce companies’ efforts to keep the identity of the chemicals confidential when health and safety studies are submitted to EPA.
EPA Updates Online Guidance Clarifying When Cleaning Products Are Considered Pesticides: On January 11, 2011, EPA announced changes to its online guidance describing when unregistered cleaning products are considered pesticides. According to an update posted by EPA’s Office of Pesticide Programs (OPP), a claim that a product “cleans or removes algae or mold stain” will now be listed online as a nonpesticidal claim rather than a pesticidal claim. The revised guidance identifies examples of claims that EPA considers as pesticidal, that it does not consider pesticidal, and those that may or may not be pesticidal depending on the context in which they are presented. More information is available online.
EPA Extends Comment Period On Weight-Of-Evidence Guidance: On December 28, 2010, EPA extended the comment period on the draft guidance document titled Weight-of-Evidence Guidance Document: Evaluating Results of EDSP Tier 1 Screening To Identify Candidate Chemicals for Tier 2 Testing. 75 Fed. Reg. 81605. Comments are now due on February 3, 2011.
EPA Issues National Guidance To Address Proper Maintenance, Removal, And Disposal Of PCB-Containing Fluorescent Lights: On December 29, 2010, EPA released guidance recommending that schools take steps to reduce potential exposures to PCBs from older fluorescent lighting fixtures. The guidance is based on evidence that the older ballasts contain PCBs that can leak when the ballasts fail, leading to elevated levels of PCBs in the air of schools that should not represent an immediate threat but could pose health concerns if they persist over time. The guidance document is available online.
EPA Announces Next Generation Risk Assessment Public Dialogue Conference: On December 30, 2010, EPA announced a two-day public dialogue conference to engage, inform, and encourage feedback from key stakeholders. 75 Fed. Reg. 82387. The conference will take place on February 15 and 16, 2011, in Washington, D.C. and will be open to attendance by interested public participants on a first-come, first-serve basis up to the limits of available space. Please consult the Federal Register for details.
SFIREG Holds Full Committee Meeting: On December 6-7, 2010, the State FIFRA Issues Research & Evaluation Group (SFIREG) held its semi-annual full committee meeting at EPA’s offices in Arlington, Virginia. Through a cooperative agreement in 1978, EPA and the Association of American Pesticide Control Officials (AAPCO) created SFIREG, an AAPCO committee with EPA funding, to promote information exchange and cooperation between the states and EPA in the development of pesticide policies and regulations. More information about SFIREG is available online. A more detailed memorandum is available online.
EPA Amends Final Greenhouse Gas Reporting Rule: On December 17, 2010, EPA amended specific provisions in the final greenhouse gas (GHG) reporting rule to clarify certain provisions, to correct technical and editorial errors, and to address certain questions and issues that have arisen since promulgation. 75 Fed. Reg. 79092. The final changes include generally providing additional information and clarity on existing requirements, allowing greater flexibility or simplified calculation methods for certain sources, amending data reporting requirements to provide additional clarity on when different types of GHG emissions need to be calculated and reported, clarifying terms and definitions in certain equations and other technical corrections and amendments. The final rule was effective on December 31, 2010.
EPA Proposes To Defer Certain Data Elements Under GHG Reporting Rule: On December 27, 2010, EPA proposed to defer for three years the reporting date of certain data elements that are inputs to emission equations under the Mandatory Greenhouse Gas Reporting Rule. 75 Fed. Reg. 81350. In response to EPA’s July 7, 2010, proposed confidentiality determinations for data required under the reporting rule, EPA received comments raising concerns that warrant further consideration before EPA issues final confidentiality determinations for data elements that are inputs to emission equations for direct emitters. To allow time for EPA to consider these comments and other information concerning these data elements before they are reported to EPA, when they may become publicly available, EPA is proposing to defer direct emitter reporting of inputs to emission equations for calendar years through 2012 until March 31, 2014. The proposal does not change other requirements of the reporting rule. EPA issued an interim final rule requiring the same deferral on the same day. 75 Fed. Reg. 81338. Comments must be received on or before January 26, 2011, unless a public hearing is requested by January 6, 2011. If a hearing is requested on this proposed rule, written comments must be received by February 10, 2011.
EPA Calls For Information On Inputs To Emission Equations Under The Mandatory Reporting Of GHGs: On December 27, 2010, EPA published a call for information and public comment to solicit certain additional information pertaining to reporting of inputs to emission equations under the Mandatory Greenhouse Gas Reporting Rule. 75 Fed. Reg. 81366. In response to EPA’s July 7, 2010, proposed confidentiality determinations for data required under the reporting rule, EPA received comments that warrant in-depth evaluation of potential harm to businesses from possible public availability of some of these data. The information and comment solicited by the notice will, according to EPA, assist it with considering a long-term approach that balances data quality and transparency with the reporting businesses’ need to protect sensitive business information. Information and comments must be received on or before February 25, 2011.
EPA Statement On Chromium-6 In Drinking Water: On December 21, 2010, EPA issued a statement and background information in response to a study released on December 20, 2010, by the Environmental Working Group. EPA stated it “absolutely has a drinking water standard for total chromium, which includes chromium-6 (also known as Hexavalent Chromium), and we require water systems to test for it. This standard is based on the best available science and is enforceable by law. Ensuring safe drinking water for all Americans is a top priority for EPA. The agency regularly re-evaluates drinking water standards and, based on new science on chromium-6, had already begun a rigorous and comprehensive review of its health effects. In September, we released a draft of that scientific review for public comment. When this human health assessment is finalized in 2011, EPA will carefully review the conclusions and consider all relevant information, including the Environmental Working Group’s study, to determine if a new standard needs to be set.” More information on chromium is available online.
More recently, on January 11, 2011, EPA released new guidance that it said would help public water systems to better monitor and evaluate the levels of hexavalent chromium in drinking water. Guidance for Public Water Systems on Enhanced Monitoring for Chromium-6 (Hexavalent Chromium) in Drinking Water responds to recent concerns that hexavalent chromium could pose health concerns if consumed over long periods of time. In the guidance, EPA stated it has outlined where and how often to collect tap water samples along with analytic methods for laboratory testing to assess the prevalence of the contaminant. EPA currently requires all public water utilities to test for total chromium, which includes hexavalent chromium. The hexavalent form of the metal is not singled out for a separate test. EPA’s maximum contaminant level for total chromium is 100 parts per billion (ppb), while California is proposing a health protection goal, not a maximum level, of 0.02 ppb for hexavalent chromium. EPA’s Guidance for Public Water Systems on Enhanced Monitoring for Chromium-6 (Hexavalent Chromium) in Drinking Water is available online.
EPA Issues Revisions To Lead Ambient Air Monitoring Requirements: On December 27, 2010, EPA issued final revisions to the lead ambient air monitoring requirements. 75 Fed. Reg. 81126. In 2009, the Natural Resources Defense Council (NRDC) and others petitioned EPA to reconsider the lead emission rate at which monitoring is required. EPA granted the petition to reconsider aspects of the monitoring requirements. In response to the petition, EPA reviewed and reconsidered the monitoring requirements and on December 30, 2009, EPA proposed revisions to the requirements for both source-oriented and non-source-oriented monitoring for lead. EPA proposed to lower the emission threshold at which monitoring would be required (or a waiver granted) to 0.50 tpy, to require lead monitoring at NCore sites, and remove the existing CBSA-based non-source-oriented monitoring requirement. This action promulgates changes to the lead monitoring requirements reflecting EPA’s consideration of the comments received on the proposed revisions. The final rule will be effective on January 26, 2011.
EPA To Defer GHG Permitting Requirements For Industries That Use Biomass: On January 12, 2011, EPA announced its plan to defer for three years GHG permitting requirements for carbon dioxide (CO2) emissions from biomass-fired and other biogenic sources. EPA stated that it intends to use the additional time to seek further independent scientific analysis of this complex issue and then to develop a rulemaking on how these emissions should be treated in determining whether a Clean Air Act (CAA) permit is required. By July 2011, EPA intends to complete a rulemaking that will defer permitting requirements for CO2 emissions from biomass-fired and other biogenic sources for three years. During the three-year period, EPA will seek input on scientific issues from its partners within the federal government and from outside scientists who have relevant expertise. Before the end of the three-year period, EPA intends to issue a second rulemaking that determines how these emissions should be treated or counted under GHG permitting requirements.
EPA stated that it intends to issue guidance that will provide a basis that state or local permitting authorities may use to conclude that the use of biomass as fuel is the best available control technology for GHG emissions until EPA can complete action on the three-year deferral in July. More information is available online.
GREEN CHEMISTRY DEVELOPMENTS
CDTSC Delays Implementation Of Safer Consumer Product Alternatives Regulations: CDTSC released a December 23, 2010, letter from Linda S. Adams, California’s Secretary for Environmental Protection, to Assembly Member Mike Feuer, the author of the 2008 law (A.B. 1879), that would require regulations to address chemicals and chemical ingredients in consumer products. In the letter, Secretary Adams responded to Feuer’s letter outlining his concerns about the CDTSC’s November 16, 2010, release of revisions to its “Safer Consumer Product Alternatives” (SCPA) regulations. In addition to Feuer’s letter, the Environmental Working Group and 32 other organizations had submitted a letter to Governor Schwarzenegger urging him to stop implementation of the SCPA regulations. A copy of Adams’ letter is available online.
Although A.B. 1879 requires CDTSC to adopt SCPA regulations by January 1, 2011, Adams states that “DTSC has agreed to take additional time to be responsive to the concerns raised and revisit the proposed regulations.” Instead, CDTSC and its regulation development team will reconvene the Green Ribbon Science Panel in early 2011 to address the “programmatic issues that have been brought to our attention via the public comment process.” Adams states that “[t]his additional time and expertise will help ensure that the vision behind this component of the Green Chemistry Initiative and implementing statute AB 1879, is fully realized.”
Based on these developments, it would appear that some of the changes in the revised regulations that industry supported could be subject to further discussion and revision. Among these issues are the proposed exemption of nanomaterials; the decision to focus the first five years on children’s products, personal care products, and household cleaning products; and the revised process by which “chemicals of concern” and “priority products” will be identified.
Comments submitted on the revised SCPA regulations (submitted between November 16, 2010, and December 3, 2010) are available online.
In addition, CDTSC has released all the public comments submitted in response to the initial version of the SCPA regulations (submitted between September 17, 2010, and November 1, 2010) and the transcript from the November 1, 2010, public hearing on these regulations. These comments and transcript are available online.
EC Committee Approves Opinion On Scientific Basis For The Definition Of Nanomaterial: On December 8, 2010, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) approved its opinion on the scientific basis for the definition of the term “nanomaterial.” The opinion concludes that:
- Whereas physical and chemical properties of materials may change with size, there is no scientific justification for a single upper and lower size limit associated with these changes that can be applied to adequately define all nanomaterials;
- There is scientific evidence that no single methodology (or group of tests) can be applied to all nanomaterials; and
- Size is universally applicable to define all nanomaterials and is the most suitable measurand. Moreover, an understanding of the size distribution of a nanomaterial is essential and the number size distribution is the most relevant consideration.
To define an enforceable definition of “nanomaterial” for regulatory use, the opinion proposes to set an upper limit for nanomaterial size and to add to the proposed limit additional guidance specific for the intended regulation. According to the opinion, it is critical that the guidance includes an extended description of relevant criteria to characterize the nanoscale. Merely defining single upper and lower cut-off limits is not sufficient in view of the size distributions occurring in manufactured nanomaterials. Alternatively, a tiered approach may be required depending on the amount of information known for any specifically manufactured nanomaterial and its proposed use. The opinion is available online.
CDTSC Issues DCI For Nano Metals, Nano Metal Oxides, And Quantum Dots: On December 21, 2010, CDTSC issued a DCI for information regarding analytical test methods, and other relevant information, from manufacturers of nanosilver, nano zero valent iron, nano titanium dioxide, nano zinc oxide, nano cerium oxide, and quantum dots. According to CDTSC, Health and Safety Code Section 57018(a)(4) defines a “manufacturer” as a “person who produces a chemical in this state or imports a chemical into this state for sale in this state.” Accordingly, CDTSC states, “persons and businesses who produce or import one or more of the above chemicals, in any quantity, must comply with the statute and this request.” CDTSC requests information about the analytical test methods that identify and quantify the specified nanomaterials, their metabolites, and their degradation products in water, air, soil, sediment, sludge, chemical waste, fish, blood, adipose tissue, and urine. CDTSC states it determined that little or no information on analytical test methods for these nanomaterials in the human body or the environment now exists. To better understand the behavior, fate, and transport of these nanomaterials, CDTSC needs “appropriate analytical test methods” for manufacturers, contract and reference laboratories, and regulatory agencies. CDTSC states that manufacturers “may be required to develop information consistent with the requirements of Health and Safety Code section 57019(c) and (d).” Manufacturers, including importers, must provide the requested information no later than one year from CDTSC’s December 21, 2010, letter, however, “timely attention and response is preferred.” More information is available online.
Switzerland Posts Guidelines For Preparing SDSs For Synthetic Nanomaterials: The Switzerland State Secretariat for Economic Affairs (SECO) has posted a December 21, 2010, guidance document for preparing safety data sheets (SDS) for synthetic nanomaterials. Safety Data Sheet (SDS): Guidelines for Synthetic Nanomaterials is intended to demonstrate the information necessary to ensure the safe handling of nano-objects and products that contain nano-objects; offer assistance on how the relevant information can be identified and in which form and which place they are to be listed in the SDSs; and contribute to making employees of companies that produce or process synthetic nano-objects aware of the particular properties of these materials. The Guidelines, which are limited to “specifically manufactured (i.e. synthetic) nano-objects which are nano-sized in two or three dimensions (i.e. nano-fibres or nano-particles),” include two fictitious examples of SDSs for synthetic nanomaterials. The Guidelines supplement the Federal Office of Public Health (FOPH) document entitled The Safety Data Sheet in Switzerland.
The Guidelines recommend that:
- Existing SDSs should be supplemented by nano-specific data as set out in the information in the present document or a separate SDS be drawn up for the nano-objects in question; and
- An SDS based on the recommendations in the present documents also be drawn up for nano-objects for which no there is no requirement as set out in the Swiss Chemicals Ordinance (ChemV, SR 813.11 Section 52).
The Guidelines are available online.
Australia Issues Guidance On New Chemical Requirements For Notification Of Industrial Nanomaterials: Australia’s National Industrial Notification and Assessment Scheme (NICNAS) recently issued guidance on the new chemical requirements for the notification and assessment of industrial nanomaterials that are considered to be new chemicals. The new administrative arrangements will be effective from January 1, 2011, and will apply to any new chemical that falls under the following working definition of “industrial nanomaterial”:
… industrial materials intentionally produced, manufactured or engineered to have unique properties or specific composition at the nanoscale, that is a size range typically between 1 [nanometer (nm)] and 100 nm, and is either a nano-object (i.e. that is confined in one, two, or three dimensions at the nanoscale) or is nanostructured (i.e. having an internal or surface structure at the nanoscale).
The guidance is available online.
EPA Regulatory Agenda Includes Several Notices Concerning Nanoscale Materials: EPA’s December 20, 2010, Regulatory Agenda includes several notices concerning nanoscale materials:
- Test Rule for Certain Nanoscale Materials — EPA states that it is developing a test rule under TSCA Section 4(a) to require manufacturers (defined by statute to include importers) and processors of the multiwall carbon nanotube described in Premanufacture Notice (PMN) P-08-199, certain clays (e.g., kaolin (including halloysite) and bentonite (including montmorillonite)), alumina, and spray-applied nanomaterials to conduct testing for health effects, ecological effects, and environmental fate, as well as provide material characterization data. EPA intends to issue a notice of proposed rulemaking (NPRM) in April 2011.
- Reporting Under TSCA Section 8(a) — Under TSCA Section 8(a), EPA is developing a proposal to establish reporting requirements for certain nanoscale materials. According to the notice, the rule would propose that persons who manufacture these nanoscale materials notify EPA of certain information including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data. The notice states that EPA intends to issue an NPRM in February 2011. EPA submitted a proposed rule to the Office of Management and Budget (OMB) for review on November 22, 2010.
- Significant New Use Rule (SNUR) — EPA is developing a SNUR for nanoscale materials under TSCA Section 5(a)(2). The SNUR would require persons who intend to manufacture, import, or process this/these chemical substance(s) for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. EPA intends to issue an NPRM in February 2011.
EPA, EC, And OECD Officials Publish Article In Nature Nanotechnology: Nature Nanotechnology has posted a pre-publication version of an article entitled “Science Policy Considerations for Responsible Nanotechnology Decisions,” which is authored by regulatory officials of EPA, EC, and the Organization for Economic Cooperation and Development (OECD). The authors offer their perspectives on possible approaches to maximizing the environmental benefits of nanotechnology and products that contain nanomaterials while minimizing the negative impacts. For the path forward, the regulators recommend that researchers and risk managers work together to develop approaches to limit exposure and identify and address those properties of specific nanomaterial types that appear to be the source of potential hazards or exposures. According to the regulators, industry “should contribute significantly to this work because it best understands the characteristics and performance of the materials it produces, as well as what types of controls (such as personal protective equipment for workers) will function best in particular occupational situations.” In recognition of the possibility to avoid risk before nanomaterials enter the environment, the regulators “support the application of a life cycle perspective and encourage the development of safer-by-design methods and approaches such as green chemistry for sustainable production of chemicals in ways that reduce environmental impact.” The article is available online.
America COMPETES Reauthorization Act Presented To President For Signature: On December 28, 2010, the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Reauthorization Act of 2010 (H.R. 5116) was presented to President Obama for signature. The bill, as unanimously passed by the Senate on December 17, 2010, does not include reauthorization of the National Nanotechnology Initiative (NNI). A spokesperson for the House Committee on Science and Technology, which guided the bill through the House, stated that the Senate version does not reauthorize the NNI because Senator Kay Bailey Hutchison (R-TX) raised objections to the provision. The House passed similar legislation on May 28, 2010, by a vote of 262-150. The House bill would have reauthorized the NNI. The Senate version, on the other hand, contains no reference to nanotechnology.
ETC Group Posts Report On Global Governance Of Nanoscale Technologies: On December 17, 2010, ETC Group published a report entitled The Big Downturn? Nanogeopolitics, which updates its 2005 nanogeopolitics survey. According to ETC Group, since 2005, policymakers have begun to acknowledge that fast-tracking nanotechnology has come at a price and that some sort of regulation is necessary to address at least some of the risks posed. ETC Group states, though, that “governments and industry, hand in hand, have come too far and invested too much to give up on nanotech’s promise of becoming the strategic platform for global control of manufacturing, food, agriculture and health — a pillar of the 21st century’s ‘green economy.'” ETC Group provides an update on the geopolitical landscape, producing a current snapshot of global investment, markets, governance, and control, including intellectual property. ETC Group is hopeful that the risks of nanotechnology will be addressed in fora such as the International Labour Organization (ILO) XIX World Congress on Safety and Health at Work in Istanbul in September 2011 and the United Nations (UN) Rio+20 Summit in 2012. The report is available online.
EFSA Begins Public Consultation On Draft Guidance On Risk Assessment For Nanoscience And Nanotechnologies: On January 14, 2011, the European Food Safety Authority (EFSA) began a public consultation on a draft document entitled “Guidance on Risk Assessment Concerning Potential Risks Arising from Applications of Nanoscience and Nanotechnologies to Food and Feed.” According to EFSA, the draft guidance offers practical guidance for the risk assessment of applications involving the use of nanoscience and nanotechnology in the area of food and feed (including food additives, enzymes, flavorings, food contact materials, novel foods, feed additives, and pesticides). The draft guidance states that the general risk assessment paradigm is applicable for these applications, and consequently appropriate data and information for the various steps should be made available to the risk assessor to carry out a risk assessment. Adequate characterization of engineered nanomaterials (ENM) is essential for establishing its identity and physico-chemical forms in food/feed products. In cases in which transformation of the ENM into a non-nanoform in the food/feed matrix or in gastrointestinal fluids is judged to be complete, then EFSA guidance for non-nanoforms for the specific intended use should apply. The ENM covered by the draft guidance fall into two categories: (1) when a nanoform of an already approved non-nanoform with the same intended use in food/feed is produced; and (2) when a new ENM without a corresponding approved non-nanoform is produced. In the situation where there is an approved non-nanoform of a substance with the same intended use in food/feed, the aim of the draft guidance is to indicate the supplementary and specific data required on the potential additional hazards and risks that may arise from the nanoform. In the situation where the ENM persists in the food/feed matrix and in gastrointestinal fluids and has no approved non-nanoform application, toxicity tests on the ENM should follow the relevant EFSA guidance for its intended use, with some modifications in the testing due to the nanoproperties. Comments are due February 25, 2011. More information is available online.
EPA Removes Saccharin And Salts From Lists Of Hazardous Constituents, Hazardous Wastes, And Hazardous Substances: EPA issued a final rule on December 17, 2010, amending its regulations under the Resource Conservation and Recovery Act (RCRA) to remove saccharin and its salts from the lists of hazardous constituents and commercial chemical products which are hazardous wastes when discarded or intended to be discarded. 75 Fed. Reg. 78918. EPA also amended the regulations under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) to remove saccharin and its salts from the list of hazardous substances. The final rule responds to a petition submitted to EPA by the Calorie Control Council (CCC) to remove saccharin and its salts from the above lists. EPA is granting CCC’s petition based on a review of the evaluations conducted by key public health agencies concerning the carcinogenic and other potential toxicological effects of saccharin and its salts, as well as EPA’s own assessment of the waste generation and management information for saccharin and its salts. This review/assessment demonstrates that saccharin and its salts do not meet the criteria in the hazardous waste regulations for remaining on EPA’s lists of hazardous constituents, hazardous wastes, and hazardous substances. The final rule is effective on January 18, 2011.
EPA To Come Under Renewed Scrutiny: Representative Mike Simpson (R-ID), the Chairman of the House Appropriations Committee’s Subcommittee on Interior, Environment and Related Agencies, issued a statement on January 7, 2011, laying down the gauntlet to EPA, stating in part that “he has his eyes set on the EPA, which has seen exponential growth in its budget since President Obama came into office.” “The EPA is the scariest agency in the federal government, an agency run amok,” Simpson stated. “Its bloated budget has allowed it to drastically expand its regulatory authority in a way that is hurting our economy and pushing an unwelcomed government further into the lives of Idahoans. As Chairman of this subcommittee, I look forward to bringing some common sense to the EPA and some certainty for our nation’s job creators.” Representative Simpson will play a central role in the process of reviewing EPA’s actions, since his Subcommittee will be responsible for recommending the funding for EPA after the Continuing Resolution presently funding the federal government runs out in March and into the next fiscal year. The activities in the appropriations process will likely overlap the review of EPA operations by the House Oversight and Government Reform Committee.
EPA GHG Efforts The Subject Of Continued Fire: From Senator Jay Rockefeller (D-WV) to the United States Chamber of Commerce (Chamber), groups are discussing several possible mechanisms to attempt to delay or dismantle the effort of EPA to regulate GHG emissions. All of these efforts are in the formative stages. The Rockefeller initiative, a carryover from the last session of Congress, would basically suspend for two years the EPA requirement that companies obtain a CAA permit for such emissions. The Chamber efforts are also intended to delay or halt the EPA efforts, as is the Protect America’s Energy and Manufacturing Jobs Act of 2011 introduced by Representative Shelley Moore Caputo (R-WV) and the Free Industry Act introduced by Representative Marsha Blackburn (R-TN). There are also measures in the works to delay or prevent funding of any EPA activity that might survive the efforts underway.
President Obama Signs Food Safety Measure: On January 4, 2011, President Barack Obama signed the Food and Drug Administration (FDA) Food Safety Modernization Act into law. The provisions of this sweeping overhaul of the laws relating to food are discussed in the “Recent Federal Developments” memorandum dated December 15, 2010, which is available online.
ECHA Adds Eight Chemicals To EU List: On December 15, 2010, ECHA announced that it has added eight chemical substances to the Candidate List of Substances of Very High Concern (SVHC) for Authorization. The listing triggers potential obligations. ECHA advised companies to check whether they have obligations that result from this listing. The eight chemicals or groups of chemicals are carcinogenic, mutagenic, and/or reprotoxic. The eight substances or groups of chemicals 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. More information, including known potential uses of the chemicals, is available online.
ECHA Received 3.1 Million Classification And Labelling Notifications: On January 3, 2011, ECHA received 3,114,835 notifications of 24,529 substances for the Classification and Labelling Inventory. By this deadline, industry had to notify the classification and labelling of all chemical substances that are hazardous or subject to registration under the REACH regulation and placed on the EU market. The Classification, Labelling and Packaging (CLP) Regulation relates to chemical substances and mixtures. It introduces into the EU the criteria of the United Nations’ GHS for classifying and labelling chemicals. One of the aims of the CLP regulation is to improve the protection of human health and the environment by providing criteria for defining when a substance or mixture displays properties that lead to its classification as hazardous. CLP applies to manufacturers, importers, users or distributors of chemical substances or mixtures. They must classify, label, and package any substance or mixture, regardless of its annual tonnage, in accordance with the Regulation. The largest number of the notifications, over 800,000, came from Germany. Over 500,000 notifications were submitted from the United Kingdom and nearly 300,000 from France. All together, over 6,600 companies notified at least one substance.
Canadian Parliament Adopts Product Safety Act: On December 14, 2010, the Canadian Parliament gave final approval to the Consumer Product Safety Act (Bill C-36). The bill prohibits the manufacture, import, marketing, or sale of consumer products deemed unsafe and requires industry to inform quickly the government of serious incidents, death, or safety issues related to consumer products. The legislation also includes restrictions on allowable lead content in certain consumer products and children’s toys and in consumer paints and other surface coatings. The bill requires the formality of royal assent before it becomes law. The government is developing an accelerated implementation plan to put the new law into effect in the next few months. The law also requires manufacturers or importers to provide, on request, test results on products; empowers Health Canada to recall dangerous products; establishes an offense for packaging or labelling that makes false or deceptive health or safety claims; and increases penalties for noncompliance. Bill C-36 is available online.
WHO Issues Guidance On Indoor Air Chemicals Of Concern: On December 15, 2010, the World Health Organization (WHO) issued guidance on chemicals of concern that could be found in indoor air. The guidance is intended to help health professionals, along with parties that design and use indoor materials and products, to protect individuals who may be exposed to any of the nine chemicals as they breathe indoor air. The guidelines include recommended exposure limits, and are recommendations not designed to be adopted as standards. The nine chemicals addressed in the report are benzene, carbon monoxide, formaldehyde, naphthalene, nitrogen dioxide, polycyclic aromatic hydrocarbons, radon, trichloroethylene, and tetrachloroethylene. WHO Guidelines for Indoor Air Quality: Selected Pollutants is available online.
OEHHA Proposes Regulations Concerning Toxics Information Clearinghouse: On December 17, 2010, the California Office of Environmental Health Hazard Assessment (OEHHA) issued proposed regulations that would specify hazard traits, environmental and toxicological endpoints, and other relevant data that are to be included in the Toxics Information Clearinghouse (Clearinghouse) the CDTSC will develop. CDTSC will use information from the Clearinghouse to help identify chemicals of concern in consumer products as part of its Green Chemistry Program. OEHHA will hold a public hearing on the proposed regulations on January 31, 2011. Comments are due February 15, 2011. More information is available online. A more detailed memorandum is available online.