Monthly Update for May 2010


FEDERAL ISSUES
TSCA/FIFRA/NTP/EPCRA

EPA Considering TSCA Section 6 Rulemaking For Long-Chain Perfluorinated Chemicals: On April 16, 2010, the U.S. Environmental Protection Agency (EPA) posted its March 2010 Action Initiation List (AIL), which includes an item entitled "Long-Chain Perfluorinated Chemicals (LCPFCs); Regulation(s) Under TSCA." The abstract for the item states:

TSCA section 6 provides authority for EPA to ban or restrict the manufacture (including import), processing, and use of these chemicals. EPA is considering initiating TSCA section 6 rulemaking for managing long-chain perfluorinated chemicals (LCPFCs). LCPFCs includes two sub-categories: perfluoroalkyl sulfonates (PFAS) and perfluoroalkyl carboxylates (PFAC). The PFAS sub-category includes perfluorohexane sulfonic acid (PFHxS), perfluorooctane sulfonic acid (PFOS), other higher homologues, and their salts and precursors. The PFAC sub-category includes perfluorooctanoic acid (PFOA, sometimes called C8), other higher homologues, and their salts and precursors. Some of those potential PFAC precursors include chemicals known commercially as fluorotelomers. PFOA is a synthetic (man-made) chemical that does not occur naturally in the environment. Companies use PFOA to make fluoropolymers, substances with special properties that have thousands of important manufacturing and industrial applications. Fluoropolymers impart valuable properties, including fire resistance and oil, stain, grease, and water repellency. They are used to provide non-stick surfaces on cookware and waterproof, breathable membranes for clothing, and are used in many industry segments, including the aerospace, automotive, building/construction, chemical processing, electronics, semiconductors, and textile industries. PFOA can also be produced by the breakdown of some fluorinated telomers, substances that are used in surface treatment products to impart soil, stain, grease, and water resistance. Some telomers are also used as high performance surfactants in products that must flow evenly, such as paints, coatings, and cleaning products, fire-fighting foams for use on liquid fuel fires, or the engineering coatings used in semiconductor manufacture. LCPFCs are found world-wide in the environment, wildlife, and humans. They are bioaccumulative in wildlife and humans, and are persistent in the environment. To date, significant adverse effects have not been found in the general human population; however, significant adverse effects have been identified in laboratory animals and wildlife. Given the long half-life of these chemicals in humans (years), it can reasonably be anticipated that continued exposure could increase body burdens to levels that would result in adverse outcomes.

According to the AIL, the projected publication date is "more than 12 months." The AIL is available online.

Court Rejects Suit On EPA TRI Reporting For 'Manufactured' Items: On March 31, 2010, the U.S. District Court for the District of Columbia rejected the mining industry's argument that EPA violated federal law by expanding its Toxics Release Inventory (TRI) reporting requirements for "manufactured" substances. Arizona Mining Association, et al. v. EPA, et al. The mining industry filed suit in 2006 seeking to narrow EPA's policy on which substances are subject to TRI reporting. Industry argued that EPA violated federal law by revising its TRI policy in 2001 to include mining extraction and separation processes under its definition of a "manufactured" substance that must be reported. Industry argued these revisions resulted in the same effect as a 1997 rule that the U.S. Court of Appeals for the District of Columbia Circuit had struck down in Barrick Goldstrike v. Whitman and National Mining Association (NMA) v. Browner. In these cases, the D.C. Circuit ruled that naturally-occurring toxins in minerals did not constitute "manufactured" substances, and invalidated the 1997 rule's claims that they were "manufactured" by nature. In the suit, industry argued that two letters sent by EPA in 2001 were in effect final agency action. They were not issued with proper notice and comment. The court rejected this claim.

Summary And Comparison Of The TSCA Reform Legislation: As reported in last month's update, on April 15, 2010, Senator Frank R. Lautenberg (D-NJ) released the text of the Safe Chemicals Act of 2010, S. 3209 (SCA), which is intended to address the "core failings" of the Toxic Substances Control Act (TSCA). Also on April 15, 2010, Representatives Bobby Rush (D-IL), Chairman of the Subcommittee on Commerce, Trade, and Consumer Protection, and Henry Waxman (D-CA), Chairman of the Energy and Commerce Committee, released a discussion draft of their legislation, the Toxic Chemicals Safety Act of 2010 (Discussion Draft). (Congressional Committees often issue "discussion drafts." These documents reflect proposals for reform of legislation, are works in progress intended to encourage and foster discussion, and are not proposed legislation.) A copy of Bergeson & Campbell, P.C.'s summary and comparison of the TSCA Reform legislation is available online. Links to the bills, summaries, and other related materials are available online.

RCRA/CERCLA

EPA Proposes To Remove Saccharin From Hazardous Waste Listings: On April 22, 2010, EPA proposed to remove saccharin and its salts from EPA's Resource Conservation and Recovery Act (RCRA) lists of hazardous wastes, hazardous constituents, and hazardous substances because it is no longer considered a potential hazard to human health. 75 Fed. Reg. 20942. Saccharin, a white crystalline powder, has been used as an artificial sweetener and is used in diet soft drinks, chewing gum, and juice. Since the 1980s, saccharin was included in EPA's lists of hazardous wastes, hazardous constituents, and hazardous substances because it was identified as potentially causing cancer in people. The National Toxicology Program (NTP) and the International Agency for Research on Cancer (IARC) re-evaluated the available scientific information on saccharin and its salts and concluded that saccharin and its salts are not potential human carcinogens. Because the scientific basis for remaining on EPA's lists no longer applies, EPA has proposed to remove saccharin and its salts from the list. Comments are due by June 21, 2010.

EPA Announces Plans To Regulate Coal Ash: On May 4, 2010, EPA proposed federal rules to ensure the safe disposal and management of coal ash from coal-fired power plants. Coal ash consists of coal combustion residuals that are byproducts of the combustion of coal at power plants and are disposed of in liquid form at large surface impoundments and in solid form at landfills. According to EPA, the residuals can contain mercury, cadmium, and arsenic. The rules are intended to provide protective controls, such as liners and groundwater monitoring, are in place at new landfills to protect groundwater and human health. Existing surface impoundments will also require liners, with incentives to close the impoundments and transition to safer landfills that store coal ash in dry form. The proposal seeks public comment on two approaches for addressing the risks of coal ash management under RCRA. One option is based on RCRA Subtitle C, which creates a comprehensive program of federally enforceable requirements for waste management and disposal. The other option includes remedies under Subtitle D, which provides EPA authority to set performance standards for waste management facilities and would be enforced primarily through citizen suits. A chart comparing and contrasting the two approaches is available on EPA's website online. Importantly, under both approaches, EPA would leave in place the Bevill exemption for beneficial uses of coal ash in which coal combustion residuals are recycled as components of products instead of placed in impoundments or landfills. According to EPA, large quantities of coal ash are used in concrete, cement, wallboard, and other contained applications that should not involve any exposure by the public to unsafe contaminants. EPA is seeking public comment on how to frame the continued exemption of beneficial uses from regulation and is focusing in particular on whether that exemption should exclude certain non-contained applications where contaminants in coal ash could pose risks to human health. More information about the proposed regulation is available online. Comments are due 90 days after publication in the Federal Register.

CAA/CWA

EPA Proposes Amendments To NSPS And Emission Guidelines For Commercial And Industrial Solid Waste Incineration Units: EPA is proposing revisions to the December 2000 new source performance standards (NSPS) and emission guidelines (EG) for new and existing commercial and industrial solid waste incineration (CISWI) units. The proposed rule would reduce emissions of a number of toxic air pollutants, including mercury, other metals, and organic air toxics, which include dioxins. Toxic air pollutants, also known as hazardous air pollutants or air toxics, are those pollutants known or suspected of causing cancer and other serious health effects. The proposed rule would establish emission limits for nine pollutants emitted from CISWI units: mercury; lead; cadmium; hydrogen chloride; particulate matter; carbon monoxide; dioxins/furans; nitrogen oxides; and sulfur dioxide. The proposed limits would keep an estimated 30,000 tons of these pollutants from being emitted into the air. Specifically, EPA expects to reduce 3,218 tons of hydrogen chloride and sulfur dioxide, 1,760 tons of particulate matter, 23,570 tons of carbon monoxide, 1,260 tons of nitrogen oxides, and 12 tons of metals (i.e., lead, cadmium, and mercury) and dioxins/furans. A CISWI unit is any device used to burn solid waste at a commercial or industrial facility. Examples of CISWI units include: units designed to discard solid waste; energy recovery units designed to recover heat that combust solid waste; waste burning kiln that combust solid waste in the manufacture of a product; and burn-off ovens that combust residual material off racks, parts, drums, or hooks so those items can be re-used in various production processes. Incinerators were the only subcategory covered in the 2000 rule. This proposed rule would cover five CISWI subcategories: incinerators; energy recovery units; waste burning kilns; burn-off ovens; and small, remote incinerators. The proposed rule has not been published in the Federal Register yet.

EPA Proposes Air Toxics Standards For Industrial, Commercial, And Institutional Boilers And Process Heaters At Major Source Facilities: EPA is proposing new standards that would reduce emissions of toxic air pollutants from new and existing industrial, commercial, and institutional boilers and process heaters at major source facilities. A major source facility emits or has the potential to emit 10 or more tons per year (tpy) of any single air toxic or 25 tpy or more of any combination of air toxics. The proposed rule would reduce emissions of a number of toxic air pollutants, including mercury, other metals, and organic air toxics, which include polycyclic organic matter (POM) and dioxins. This rule will apply to two types of units, neither of which burn solid waste: boilers, which burn natural gas, fuel oil, coal, biomass (e.g., wood), refinery gas, or other gas to produce steam -- the steam is used to produce electricity or provide heat; and process heaters, which heat raw or intermediate materials during an industrial process. Boilers and process heaters are used at industrial facilities such as refineries, chemical and manufacturing plants, and paper mills and may stand alone to provide heat for commercial facilities such as shopping malls or institutional facilities such as universities. Most major source boilers and process heaters are located at industrial facilities. The proposed rule would include specific requirements for each subcategory. The proposed rule has not been published in the Federal Register yet.

EPA Proposes Air Toxics Standards For Industrial, Commercial, And Institutional Boilers At Area Source Facilities: EPA plans to issue a proposed rule to revise standards for existing and new industrial, commercial, and institutional boilers located at area source facilities. An area source facility emits or has the potential to emit less than 10 tpy of any single air toxic or less than 25 tpy of any combination of air toxics. The proposed rule would reduce emissions of a number of toxic air pollutants, including mercury, metals, and organic air toxics, which include dioxins. Boilers burn coal and other substances such as oil or biomass (e.g., wood) to produce steam or hot water, which is then used for energy or heat. They can also burn non-waste materials but do so usually only in small amounts. Industrial boilers are used in manufacturing, processing, mining, refining, or any other industry; commercial and institutional boilers are used in commercial establishments, medical centers, educational facilities and municipal buildings; and the majority of area source boilers covered by this proposed rule are located at commercial and institutional facilities. The proposal would cover boilers located at area source facilities that burn coal, oil, or biomass, or non-waste materials, but not units that burn solid waste. EPA is proposing to regulate area source boilers based on boiler design. The proposal would also set different requirements for large and small boilers. Large boilers have a heat input capacity equal to or greater than 10 million British thermal units per hour (Btu per hr). Small boilers have a heat input capacity less than 10 million Btu per hour. The proposed rule has not been published in the Federal Register yet.

EPA Issues Final "Tailoring" GHG Permitting Rule: On May 13, 2010, EPA issued what it describes as a "common sense" approach to addressing greenhouse gas (GHG) emissions from stationary sources under the Clean Air Act (CAA) by phasing-in the deadlines by which facilities must obtain permits for GHG emissions. Specifically, this controversial final rule sets thresholds for GHG emissions that define when permits under the New Source Review (NSR) Prevention of Significant Deterioration (PSD) and Title V Operating Permit programs are required for new and existing industrial facilities. The rule has not yet been published in the Federal Register. The final rule and related materials can be accessed via EPA's website online; the rule will be effective 60 days after it appears in the Federal Register.

The scope of the rule is broad, both with respect to GHGs covered and the industry sectors impacted. For purposes of this rule, GHGs are defined to include carbon dioxide (CO2), methane (CH4), nitrous oxide (N2O), hydrofluorocarbons (HFCs), perfluorocarbons (PFCs), and sulfur hexafluoride (SF6). Major sectors of the economy are likely to be impacted by this final rule, including agriculture, mining, utilities, natural gas, manufacturing, paper manufacturing, petroleum and coal products, chemical manufacturing, and the metals industry. The largest emitters of GHG within these sectors will be required to obtain or modify their permits to address emissions of GHG during the first phase of the rule's implementation. Permitting for smaller sources of GHG emissions will be deferred for the second phase.

The so-called "tailoring" rule limits which facilities will be required to obtain PSD and Title V permits. It does so by establishing a schedule that will initially focus CAA permitting programs on the largest sources of GHG emissions. During this initial phase, only stationary sources already regulated by the PSD or Title V programs will be regulated, and then only if they emit large quantities of GHGs. The rule then expands to cover the largest sources of GHG that may not have been previously covered by the CAA for other pollutants. EPA believes this tailored approach is necessary because, the Agency argues, without it tens of thousands of facilities would be subject to permitting requirements for GHG emissions.

There is logic in the overall approach. The CAA permitting program emissions thresholds for criteria pollutants such as lead, sulfur dioxide, and nitrogen dioxide are 100 and 250 tons per year (tpy). While these thresholds are appropriate for criteria pollutants such as lead, they are not feasible for GHGs because they are emitted in much higher volumes. Without this tailoring rule, the lower emissions thresholds of 100 and 250 tpy would take effect automatically for GHGs on January 2, 2011. According to EPA, PSD and Title V requirements at these thresholds would lead to dramatic increases in the number of required permits -- tens of thousands of PSD permits and millions of Title V permits.

The immediate origin of this rule is an April 2007 Supreme Court decision. The Court found that GHGs, including carbon dioxide, are air pollutants covered by the CAA. Massachusetts v. EPA, 549 U.S. 497 (2007). The Court also found that EPA was required to determine whether or not emissions of GHGs from new motor vehicles cause or contribute to air pollution which may reasonably be anticipated to endanger public health or welfare, or whether the science is too uncertain to make a reasoned decision. In April 2009, EPA responded to the Court by proposing a finding that GHGs contribute to air pollution that may endanger public health or welfare.

The next steps in this somewhat convoluted regulatory history were two findings that EPA Administrator Lisa P. Jackson issued in December 2009. First, Administrator Jackson issued an "endangerment finding" that the current and projected atmospheric concentrations of six GHG pollutants threaten the public health and welfare of current and future generations. Next, Administrator Jackson found that the combined emissions of these GHGs from new motor vehicles and new motor vehicle engines contribute to the GHG pollution which threatens public health and welfare. While these findings do not impose any requirements, they were a prerequisite to finalizing the GHG standards for light-duty vehicles.

Another piece of this regulatory program is a memorandum issued by EPA entitled "EPA's Interpretation of Regulations that Determine Pollutants Covered by Federal Prevention of Significant Deterioration (PSD) Permit Program" (PSD Interpretive Memo). Whether a pollutant is "subject to regulation" is important for the purposes of determining whether it is covered under the CAA permitting programs. The PSD Interpretive Memo established that a pollutant is "subject to regulation" only if it is subject to either a provision in the CAA or regulation adopted by EPA under the CAA that requires actual control of emissions of that pollutant.

On February 17, 2009, however, EPA granted a petition for reconsideration of this memorandum. Subsequently, on March 29, 2010, Administrator Jackson signed a notice conveying the Agency's decision to continue applying the PSD Interpretive Memo's interpretation of "subject to regulation." As a consequence, EPA established that CAA permitting requirements apply to a newly regulated pollutant at the time a regulatory requirement to control emissions of that pollutant "takes effect" (rather than upon promulgation or the legal effective date of the regulation containing such a requirement). Based on the anticipated promulgation of the light-duty vehicle rule, the notice stated that the GHG requirements of the vehicle rule would trigger CAA permitting requirements for stationary sources on January 2, 2011.

The confluence of these events -- existing requirements under the PSD and Title V permitting programs, the Supreme Court decision, EPA's endangerment finding and PSD Interpretive Memo, and the effective date of the GHG rule for mobile sources -- has forced EPA to regulate GHG emissions under the PSD and Title V programs. Because of the potential impact of such a rulemaking, EPA found it necessary to consider an approach to regulating sources of GHGs in a manner that attempts to impose a reasonable deadline for permitting. EPA thus is implementing the rule in two phases.

During the first phase -- from January 2, 2011, to June 30, 2011 -- only sources currently subject to the PSD permitting program would be subject to permitting requirements for their GHG emissions under PSD. For these projects, only GHG increases of 75,000 tpy or more of total GHG would need to determine the Best Available Control Technology (BACT) for their GHG emissions. Similarly for the Title V permit program, only sources currently subject to the program would be subject to Title V requirements for GHG. During this first phase, no sources would be subject to permitting requirements due solely to GHG emissions.

In the second phase -- July 1, 2011, to June 30, 2013 -- PSD permitting requirements will for the first time apply to new construction projects that emit GHG emissions of at least 100,000 tpy even if they do not exceed the permitting thresholds for any other pollutant. Modifications at existing facilities that increase GHG emissions by at least 75,000 tpy will be subject to permitting requirements, even if they do not significantly increase emissions of any other pollutant. During this phase, operating permit requirements will, again for the first time, apply to sources based on their GHG emissions even if they would not apply based on emissions of any other pollutant. Facilities that emit at least 100,000 tpy carbon dioxide equivalents will be subject to Title V permitting requirements.

REACH

EU Agency Publishes List Of Chemicals Scheduled For Registration Under REACH: On April 16, 2010, the European Chemicals Agency (ECHA) published a list of 4,415 substances that it expects to be registered by a deadline of November 30 in compliance with the European Union's (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) legislation. The list was compiled from information supplied by companies about their plans to register substances and will be updated periodically. ECHA stated that: "It is therefore important that downstream users consult the list to make sure that their high volume and hazardous substances are included (lower volume and less hazardous substances don't have to be registered this year)." ECHA recommends that manufacturers and importers also consult the list and "actively help to make it complete by adding their own planned registrations." ECHA provides information on its website on what to do next if a substance that should be registered in 2010 is not on the list. Companies using substances not on the list were urged to consult with their suppliers to determine out about the suppliers' intentions to register. More information about the ECHA list of substances identified for registration in 2010, and a link to the list, are available online.

EC Announces Final Report On Member State Penalties: On April 27, 2010, the European Commission (EC) announced the availability of the final report entitled Report on Penalties Applicable for Infringements on the Provisions of the REACH Regulation in the Member States, which is based on the contractor's analysis of member states' provisions for REACH enforcement penalties notified to the EC, and subsequent feedback from member states' Competent Authorities. The aim of the Report is to provide support to the EC in creating "an objective and exhaustive overview of provisions on penalties applicable for infringement of the provisions of" REACH. The Report focuses on the current provisions set out in member states' national law and notified to the Commission on the penalties applicable for infringements of REACH. The Report notes that, at present, "there is only limited REACH enforcement experience available, given that REACH implementation is still at an early stage," and the comparison of levels of fines in different member states should be understood in this context. The Report concludes:

The comparative analysis indicates that the penalties set forth in national legislation for breaches of REACH obligations vary significantly from one country to another. The penalties in place are based on the different national cultures of enforcement and the corresponding array of compliance instruments already in place in the countries. The overall level of harmonisation of the sanctions for infringement of REACH across the EU Member States and the EEA countries is quite low.

 

The discrepancies observed in the level of penalties could lead to a risk of some companies avoiding countries with a more stringent compliance system. This could eventually impair the functioning of the internal market, as well as reduce the level of protection of human health and the environment in those countries with less severe systems of penalties. Moreover, in most countries the levels of penalties do not reflect the specificities of the REACH regime in that when the tonnage of a production or import is more than 1000 tonnes, the level of fine is not high enough to meet the cost of compliance. Such lacunas carry the risk of providing insufficient incentive for companies to comply with their obligations under REACH, particularly for those which produce or import chemicals in large quantities.

The Report is available on the Internet online.

ECHA Announces Publication Of Documents: The May 5, 2010, issue of ECHA's e-News states that ECHA has published the following items:

  • Opinion on the Use of Boric Acid and Borate Compounds: ECHA's Committee for Risk Assessment (RAC) adopted an opinion on April 29, 2010, on the use of boric acid and borate compounds by consumers in photographic applications. The opinion concerns the use of the substances by amateur photographers to develop and print their own photographs from films in the darkroom. In its opinion, RAC concluded that the use of these substances does not pose a risk to consumers when no other boron sources are considered. More information is available online;
  • ECHA Updates "Consumer Exposure Estimation": On April 29, 2010, ECHA announced that it issued an update of the "Consumer Exposure Estimation" (Chapter R.15) of the Guidance on Information Requirements and Chemical Safety Assessment. According to ECHA, the update is necessary to introduce the latest developments in exposure estimation tools for consumers. More information is available online;
  • Updated Guidance on Use Descriptor System: On May 5, 2010, ECHA posted updated guidance on the use descriptor system, which is now available in 22 EU languages. More information is available online;
  • REACH-IT Data Submission Manual Part 15 - Dissemination: How to Determine What Will Be Published on the ECHA Website from the Registration Dossier: On May 4, 2010, ECHA posted Part 15 of the REACH-IT Data Submission Manual. ECHA states that the Manual provides information about the online access to information on registered chemical substances. The Manual is intended for industry, and in particular, managers and technical experts in companies who are responsible for ensuring that comprehensive information is entered in registration dossiers. ECHA expects that the Manual will help readers to understand the basic rules ECHA applies when it disseminates information on registered chemicals, which information will be made publicly available on the ECHA website, and what are the steps in the (largely) automated dissemination process. More information is available online;
  • Draft Guidance on Derivation of DNEL/DMEL from Human Data: On May 4, 2010, ECHA posted the draft guidance on derivation of derived no-effect level (DNEL)/derived minimum-effect level (DMEL) from human data, which ECHA developed as a "relatively independent/stand alone document" to be used in the chemical safety assessment of substances for which relevant human data are available. More information is available online;
  • Draft Update of the Guidance on the Exposure Scenario Format: On May 4, 2010, ECHA posted a draft update of the guidance on the exposure scenario format, which describes the information requirements under REACH with regard to substance properties, exposure, use and risk management measures, and the chemical safety assessment. More information is available on the Internet online;
  • ECHA Calls for Information to Avoid Unnecessary Animal Testing: ECHA has posted the substances, hazard endpoints, deadlines for submitting information, and links to the submission format for which ECHA is currently requesting "scientifically valid information" from third parties. More information is available online; and
  • Public Consultation on Harmonized Classification and Labeling of Chloroform: On April 30, 2010, ECHA began a public consultation on the harmonized classification and labeling of chloroform. Comments are due June 14, 2010. More information is available online.

NANOTECHNOLOGY

University Report Offers Recommendations On California Nanomaterials Regulation: On April 22, 2010, the California Office of Environmental Health Hazard Assessment (OEHHA) issued a report that examines the policy and risk assessment challenges nanomaterials pose. The document includes specific policy recommendations on how OEHHA can address the potential health risks from exposure to the tiny particles. OEHHA's Scientific Advisory Panel (SAP) convened a meeting on May 5, 2010, in Oakland to discuss the report, A Nanotechnology Policy Framework for California (DRAFT), and other business. The report suggests that existing state policies and laws could be employed to identify and define particles and "priority" properties, develop a list of characteristics for nanomaterials, and create a framework for making regulatory decisions based on use of nanomaterials and their exposure potential. They also could be used to assess potential exposure risks using existing hazard traits from other chemicals and toxicological and environmental-health-related endpoints, evaluate risk assessment guidelines to determine if they can sufficiently cover nanomaterials, and require labels to specify that a product contains nanomaterials. Other recommendations in the report call for California to develop definitions that describe the difference between a nanomaterial or nanoparticles and other small-molecule chemicals, identify the existing sources of nanomaterials, collect information on the fate and transport of the materials, and require the consumer products made with nanomaterials already on the market to be tested for exposure potential. A copy of the report is available online.

PPDC Discusses Nanotechnology And Pesticides: At EPA's Pesticide Program Dialogue Committee (PPDC) April 29, 2010, meeting, William Jordan, Senior Policy Advisor, Office of Pesticide Programs (OPP), presented slides regarding nanotechnology and pesticides. Jordan briefly described how OPP is defining nanoscale materials and how the technology is being applied to the field of pesticides. His presentation described OPP's recent consultation with EPA's SAP concerning nanosilver and other nanometal pesticide products, as well as other ongoing regulatory activity and future actions OPP intends to take. The background materials from the meeting are available online, and the slides are available online. OPP's working definition of nanomaterial is: an ingredient that contains particles that have been intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers. Although nanomaterials occur naturally and can be produced unintentionally, Jordan noted that OPP's working definition includes the phrase "intentionally produced," and that those are the ones OPP intends to address. According to Jordan, there is at least one registered product that contains nanomaterials. The notice will also announce a new interpretation of FIFRA Section 6(a)(2) regulations and propose a new policy in June 2010. The new interpretation will be that the presence of a nanoscale material is reportable under FIFRA Section 6(a)(2). This controversial interpretation would apply to already registered products, as well as products pending registration. The interpretation would constitute an interpretation of FIFRA and elaboration on the regulations governing reporting of unreasonable adverse effects. Jordan also announced that OPP intends to respond in June 2010 to the International Center for Technology Assessment's (ICTA) May 2008 petition. In its petition, ICTA urged EPA to regulate nanosilver products as pesticides. According to ICTA, even in its bulk form, "silver is extremely toxic to fish and other aquatic species" and at the nanoscale, nanosilver can be "many times more toxic." ICTA points to "preliminary evidence" that nanosilver can exert effective antibacterial action at a considerably lower concentration than that of silver ions, suggesting that the antibacterial properties and toxicity of nanosilver are not explained only by its chemical composition and by the production of silver ions alone. ICTA asked EPA to take action on an estimated 600 unregistered nanosilver products marketed in the U.S. Jordan also noted that the Office of Research and Development developing a Draft Case Study on nanosilver (expected in 2010).

European Lawmakers Call For Restrictions On Use Of Nanoscale Ingredients In Foods: On May 4, 2010, the European Parliament's (EP) Committee on the Environment, Public Health, and Food Safety voted on draft legislation regarding "novel foods," which are defined as those that have not been consumed to a significant degree in the EU before May 1997. Under the legislation, foods produced by nanotechnology processes would be required to undergo risk assessment before being approved for use, and approved products would be subject to labeling requirements. According to the Committee, foods produced by nanotechnology processes must remain excluded from the European Community list until they have undergone specific and adequate risk assessments, and the possible health effects of materials at nanoscale are better understood. The draft legislation would define nanomaterials as having one or more dimensions less than 100 nanometers (nm). All ingredients present in nano-form would need to be clearly indicated in the list of ingredients. The European Parliament plenary vote on the draft legislation is scheduled for July 2010. The European Parliament's legislative dossier on proposals to regulate novel foods is available online.

LEGISLATIVE DEVELOPMENTS

NNI Reauthorization Initiative Begins In The House: On April 28, 2010, the House of Representatives Science and Technology Committee passed H.R. 5116, the "America COMPETES Reauthorization Act of 2010." Among the several titles in the measure is the National Nanotechnology Initiatives (NNI) Amendments Act of 2010, reauthorizing the NNI. The amendments include a requirement to develop within 12 months a strategic plan to guide near-term and long-term objectives for the NNI. That plan would be updated every three years and among other provisions would focus on how the program would move nanotechnology from the laboratory into applications that benefit society, utilizing among other resources nanotechnology research, development and transition initiatives supported by the states. The plan would also state how the program would support and encourage interdisciplinary research and development and also research into areas of national importance as described in the amendments. Each of the agencies participating in the program is obligated by the amendments to support the effort with funds in the same proportion as the agency's share of the total program budget for the prior year. The agencies are also directed to support the activities of committees involved in the development of standards for nanotechnology and said agencies are permitted to reimburse travel costs of scientists and engineers who participate in such committee activities.

The amendments direct the National Nanotechnology Coordination Office (NNCO) to develop and maintain a database of funded projects in the environmental, health and safety, educational and science and nanomanufacturing dimensions. The database is to describe the project, the source of its funding, and the funding history. On a broader scale, the NNCO is to develop, maintain, and publicize information on nanotechnology facilities supported under the program (and by the states if so desired). The key element of that portion of the database is information on the accessibility of the facility to individuals from academia and from industry, and the terms applicable to that access. Provision is also made for a triennial review of the Program, with reference to the appropriateness of funding of projects, the effectiveness of the Program management, the Program's scientific and technical accomplishments and success in transferring the technology to the private sector and the adequacy of the activities addressing ethical, legal, environmental and other societal concerns, including human health concerns.

H.R. 5116 provides that the Program will have a Coordinator for the Societal Dimensions of Nanotechnology, who would be responsible for developing a plan for the coordination, planning and budgeting for the prioritization of programs in the environmental, health and safety and educational and societal dimensions. Among other enumerated duties, that Coordinator would encourage and monitor participating agencies to ensure that they are addressing the ethical, legal, environmental and other appropriate societal concerns relating to nanotechnology, including human health concerns An important part of the plan to be implemented is the development of standards long discussed as a way to permit the comparison of research conducted into areas of nanotechnology. The standards would be of three types. The first would be standards related to nomenclature associated with nanoscale materials. The second would pertain to engineered nanoscale standard reference materials for environmental and health and safety testing, and the third would be standards related to methods and procedures for detecting, measuring, monitoring, sampling and testing engineered nanoscale materials for environmental, health, and safety impacts.

The amendments address three additional areas of interest: technology transfer, research in areas of national interest, and nanomanufacturing. Technology transfer means that the agencies supporting research facilities will make access to those facilities available to companies to assist the companies in developing prototypes of nanoscale products or products enabled by nanotechnology, for the purpose of determining proof of concept. The agencies involved are directed to publicize the availability of the facilities and encourage their use by companies, after establishing procedures regarding use. Companies can be required to reimburse agencies for the costs associated with facility use, or the agencies can waive all or a portion of said costs. Regarding research in areas of national importance, the amendments define such areas as those that have the potential for significant contributions to "national economic competitiveness and for other significant societal benefits." The activities supported are to be designed to advance the development of research discoveries by demonstrating technical solutions to important problems in such areas as nano-electronics, energy efficiency, health care and water remediation and purification.

The provisions relating to nanomanufacturing research have two key elements: the development of instrumentation and tools to rapidly characterize nanoscale materials and to monitor the nanoscale manufacturing processes, and the development of approaches and techniques for scaling the syntheses of new nanoscale materials to achieve industry level production rates. There are a variety of other provisions relating to the support of green nanotechnology development, and the review of the nanomanufacturing effort being supported by government funds.

Senator Feinstein Acts On BPA Concerns: Senator Dianne Feinstein (D-CA) has indicated that she will take some action to include either a ban or restrictions on the use of Bisphenol A (BPA) in the Food Safety Modernization Act (Act), a measure that is on the Senate's legislative calendar under general orders. The bill is expected to be considered after financial reform. While major business groups have indicated support for the Act, several have expressed concern regarding the BPA proposal and indicated they might not support the underlying bill because they contend there is no health risk warranting the BPA action and no suitable alternative for beverage containers and canned foods in widespread use.

Legislation Relating To Endocrine Disruptors Introduced: EPA would be directed to extend the screening program for the presence of endocrine disruptors in drinking water if legislation introduced by Representative Edward Markey (D-MA) and Representative James Moran (D-VA) is enacted. The measure, the Endocrine Disruptor Screening Enhancement Act of 2010, calls for EPA to develop a plan and a schedule for the testing of no fewer than 100 substances that may be found in drinking water to determine their effect on the endocrine system, if a substantial population might be exposed to those substances. At least 25 substances on the list would need to be tested per year, and EPA is directed to prioritize the selection of substances that pose the greatest public health concern, taking into consideration (among other factors of public health concern) the effect of such substances on subgroups that comprise a meaningful portion of the general population (such as infants, children, pregnant women, the elderly, individuals with a history of serious illness, and other subpopulations) that are identifiable as being at greater risk of adverse health effects due to exposure to substances in drinking water. Other provisions relate to the development, review and evaluation and necessary changes to the protocols pursuant to which testing would be conducted. EPA is to begin by publishing a guidance on the development of protocols, including the manner in which the Administrator will evaluate and revise, as needed, protocols, as well as how the Administrator will determine whether testing will be required. The guidance is also to set forth the procedures by which other scientifically relevant information can be used in lieu of some or all of the information that otherwise would be collected pursuant to testing. As to testing, provision is made for the acceleration thereof if a substance is known to be found in sources of drinking water, a substantial population is known to be exposed to the substance, and the substance is either suspected to be an endocrine disruptor or has a structural similarity to a substance known to be an endocrine disruptor. Other provisions relate to the use of the results obtained by the testing. Not later than six months after receipt of testing results for a substance, the Administrator is directed to prepare and publish data evaluation records for such results in a publicly searchable database. In that same time frame, the Administrator is made to determine whether to take action related to the substance, and publish such determination in said database. To assess the overall weight of the evidence and relevance to humans and wildlife of results of testing, the Administrator would develop and use a structured evaluative framework consisting of science-based criteria, consistent with the protection of public health and the environment, for systematically evaluating endocrine mode of action and for determining data relevance, quality, and reliability.

Home Star Program Approved By House Of Representatives: The House approved the Home Star Energy Retrofit Act of 2010 on May 6 by a vote of 246-161, after adopting an amendment by Joe Barton (R-TX) requiring that the program be deficit-neutral. The measure, originally introduced by Peter Welch (D-VT), establishes mechanisms to grant rebates through a Silver Star Home Energy Retrofit Program to homeowners that install air-sealing and insulation measures, duct seal or replacement, window or door replacement, heating or cooling system replacement and water heater replacement. A Gold Star Program will be available for retrofit work that achieves whole home energy savings. More than $6 billion dollars is included for the rebates program, and homeowners will receive the rebates directly. The legislation provides up to $5,000.00 for Silver Star rebates and up to $8,000.00 for the Gold Star program. The rebates would be excluded from taxable income for tax purposes. The aforesaid amendment offered by Representative Barton also calls for the program to be limited to home owners with annual household incomes of $250,000.00 or less. Another feature of the bill is $600 million over a two year period for grants up to $7,500.00 for the replacement of manufactured homes built prior to 1976 with rated manufactured homes. A similar Senate measure, S. 3177, was introduced by Senator Jeff Bingaman (D-NM.) on March 25 and referred to the Senate Finance Committee.

American Power Act Discussion Draft Released: Senators John Kerry (D-MA) and Joe Lieberman (ID-CT) released for discussion on May 12, 2010, a draft of the American Power Act. The 987-page draft includes provisions that set a target for national pollution reduction and fund investment of technology to harness domestic energy supplies and regain, in the words of Senator Lieberman, America's competitive edge in the global clean energy economy. To summarize certain key provisions of the measure, the legislation seeks to support the development of coal, natural gas, nuclear and renewable energy sources. The American Power Act would have the Nuclear Regulatory Commission (NRC) develop and implement procedures that would expedite the licensing process. Some $54 billion would be made available for loan guarantees, standby support would be provided for plant delays and administrative hearings would be shelved for non-contested issues prior to construction permitting and operating licensure. Various tax incentives, such as accelerated depreciation, would be provided. In light of the current situation in the Gulf, states could prohibit leasing for oil and gas exploration within 75 miles of its coastline. Regulation to achieve reduction of greenhouse gas emissions would undergo revision, with a single set of rules put in place instead of what are referred to in the bill summary as a patchwork of conflicting state and federal regulation. State cap and trade programs would end, but the trade-off would be compensation for lost revenue for those states that took a leadership role. GHG prices would be subject to a hard price collar, and participation in auction and primary cash markets would be restricted to entities with a compliance obligation, and a few others Reduction targets would be restricted to those who produce more than 25,000 tons of carbon pollution annually -- estimated to be some 7,500 factories and power plants. Monies by oil companies to purchase carbon allowances would be used in part to fund clean energy projects. $2 billion would be provided for investment in clean coal technologies, and disincentives would be removed for natural gas generation at merchant plants.

Reps. Waxman And Markey Seek To Address SDWA Issues: Representatives Henry Waxman (D-CA) and Edward Markey (D-MA) have released the Assistance, Quality and Affordability Act of 2010, a measure to revamp the Safe Drinking Water Act (SDWA). The Representatives are proposing to allocate almost $13 billion over a five year period for the repair of the nation's drinking water infrastructure. The measure would provide for the reauthorization of the drinking water revolving fund program for the first time since 1996. In remarks released on the bill at a May 13, 2010, hearing held by the Energy and Environment Subcommittee of the House Energy and Commerce Committee, Mr. Markey said that the infrastructure repairs to be funded under the legislation will lead to the creation of more than 100,000 new jobs over the five year period in question. Representative Markey also pointed to provisions of the legislation that would increase enforcement and hold to account systems that have violated drinking water standards in the past, and language to strength the EPA's Endocrine Disruptor Screening Program.

Senator Brown Moves To Extend Energy Credit Project: Senator Sherrod Brown (D-OH) and four co-sponsors introduced a bill on May 6 to extend the Advanced Energy Project Credit, to promote domestic manufacturing of clean energy technology and, in the Senator's words, help make Ohio "the Silicon Valley of Clean Energy Manufacturing." The credits are intended to be used by manufacturers retooling for the clean energy economy, which would have the important effect of keeping jobs in the United States. In his press release accompanying the measure, Senator Brown focused on the Wind Industry, and the need to support it in the face of competition from overseas. The monies provided could be taken in the form of grants instead of tax credits, at the option of the recipient, a change from the original legislation. The Credit Project is presently said to be oversubscribed by a factor of three, and the sponsors view the Credit Project as a way for the U.S. to restore its manufacturing base and create good-paying jobs.

MISCELLANEOUS

PA Announces Regional Administrator For Region 5: On April 22, 2010, EPA Administrator Jackson announced President Barack Obama's selection of Susan Hedman to be EPA's Regional Administrator for EPA's Region 5. Region 5 includes Illinois, Indiana, Michigan, Minnesota, Ohio, Wisconsin, and 35 Tribal Nations. Since 2005, Hedman has served as Illinois Attorney General Lisa Madigan's Environmental Counsel and Senior Assistant Attorney General, playing a role as chief negotiator for litigation and legislation relating to environmental protection, energy efficiency, renewable energy, carbon capture technology and associated consumer issues. Prior to that, Hedman held numerous positions in environmental law and policy including senior policy advisor on energy and recycling at the Illinois Department of Commerce and Economic Opportunity; staff attorney for the Environmental Law and Policy Center; First Legal Officer for the United Nations Security Council team charged with analyzing environmental damage from oil fires in Kuwait; and as research director for the Center for Global Change at the University of Maryland. Hedman earned her B.A. in Politics and Government from Ripon College in Ripon, Wisconsin, before earning her M.A. from the La Follette Institute of Public Affairs at the University of Wisconsin-Madison in 1979. Hedman obtained her J.D. from the University of Wisconsin Law School in 1987 before earning a Ph.D. from the Gaylord Nelson Institute for Environmental Studies in Madison, Wisconsin, two years later.

EPA Announces Administrator For Region 8: On April 21, 2010, Administrator Jackson announced the appointment of James B. Martin to be the Regional Administrator in Region 8 in Denver. Region 8 includes Colorado, Montana, North Dakota, South Dakota, Utah, Wyoming, and 27 tribal nations. Currently, Martin is the executive director of the Colorado Department of Natural Resources.

PHMSA Announces New On-Line Hazardous Materials Special Permit Application Process: On April 21, 2010, the U.S. Department of Transportation (USDOT) and its Pipeline and Hazardous Materials Safety Administration (PHMSA) rolled out a new on-line application process for applications for hazardous materials special permits. The new system, which was effective on May 1, 2010, accepts applications 24 hours a day, provides immediate confirmation of an application along with a tracking number, and allows an applicant to attach supporting documentation. The on-line application web link can be found online.

EPA Issues Semiannual Regulatory Agenda: On April 26, 2010, EPA issued its semiannual regulatory agenda. 75 Fed. Reg. 21872. The agenda updates the public on regulations and major policies currently under development. In the agenda, EPA Administrator Lisa Jackson outlined seven themes to focus EPA's work: taking Action on Climate Change; improving Air Quality; assuring the Safety of Chemicals; cleaning Up Our Communities; protecting America's Waters; expanding the Conversation on Environmentalism and Working for Environmental Justice; and building Strong State and Tribal Partnerships. Concerning the safety of chemicals, EPA states that one of its "highest priorities is to make significant progress in assuring the safety of chemicals in our products, our environment, and our bodies." EPA is "shifting [its] focus to address high-concern chemicals and filling data gaps on widely produced chemicals in commerce." According to the agenda, more chemical management plans "are underway." In addition, using the "streamlined" Integrated Risk Information System, EPA "will continue strong progress toward rigorous, peer-reviewed health assessments on dioxins, arsenic, formaldehyde, [trichloroethylene], and other substances of concern." Also according to the agenda, EPA intends to publish in September 2010 a notice of proposed rulemaking (NPRM) that EPA is proposing to add a category of eight phthalates, a category of polybrominated diphenyl ethers, and BPA to a list of chemical substances that EPA finds present or may present an unreasonable risk of injury to human health or the environment. EPA would propose this rule using the authority provided under TSCA Section 5(b)(4). EPA states that it "is concerned that the hazards of these substances and the magnitude of human and/or environmental exposure indicates that they may present an unreasonable risk to human health and/or the environment." The NPRM would also propose conforming changes to the TSCA Section 12(b) export notification regulations.

EPA Opens Access To Chemical Information: EPA is making it easier to find chemical information online. EPA is releasing a database, called ToxRefDB, which allows scientists and the interested public to search and download thousands of toxicity testing results on hundreds of chemicals. ToxRefDB captures 30 years and $2 billion of testing results. "Tens of thousands of chemicals are in commerce and current chemical testing is expensive and time consuming.

Results from chemical testing are scattered throughout different sources," stated Dr. Robert Kavlock, director of EPA's National Center for Computational Toxicology. "ToxRefDB allows the public to search, find and compare available studies about chemical toxicity and potential health effects." ToxRefDB provides detailed chemical toxicity data in an accessible format. It is a part of ACToR (Aggregated Computational Toxicology Resource), an online data warehouse that collects data from about 500 public sources on tens of thousands of environmentally relevant chemicals, including several hundred in ToxRefDB. Those interested in chemical toxicity can query a specific chemical and find all available public hazard, exposure, and risk-assessment data, as well as previously unpublished studies related to cancer, reproductive, and developmental toxicity. ToxRefDB connects to an EPA chemical screening tool called ToxCast. ToxCast is a multi-year, multi-million dollar effort that uses advanced science tools to help understand biological processes impacted by chemicals that may lead to adverse health effects. ToxCast currently includes 500 fast, automated chemical screening tests that have assessed over 300 environmental chemicals. ToxRefDB, along with ACToR, allows users to take advantage of this linkage to find and download these results. ToxRefDB contains toxicity information that forms the basis for pesticide risk assessments when combined with other sources of information, such as those on exposure and metabolism. More information on the database is available online.

OSHA Releases Toxic Exposure Workplace Measurements: On April 30, 2010, the Occupational Safety and Health Administration (OSHA) released a database detailing 15 years of hazardous chemical exposure measurements taken by the agency's compliance officers at workplaces. OSHA made available 15 years of personal, area, and bulk samples in downloadable zip files. For more information, see online.

Canada Issues Draft Order Designating Methanone, 2-Butanone, Oxirane As Toxic: On May 1, 2010, Environment Canada and Health Canada published a draft order designating methanone, 2-butanone, and oxirane as toxic substances under the Canadian Environmental Protection Act (CEPA). The substances were the only ones to meet the toxicity criteria in Section 64(c) of the Act among 14 priority chemicals in the seventh batch of substances assessed under the Challenge to Industry process, a part of the federal government's 2006 Chemicals Management Plan, the departments said in the draft order published in the Canada Gazette, Part I. The draft order to designate methanone, 2-butanone, and oxirane as toxic substances under CEPA is available online.

IARC Identifies Chemicals It Will Review: On May 4, 2010, IARC identified the substances it will evaluate at a meeting early next year in preparation for the latest volume of its publication examining sources of cancer in humans. According to a list available on IARC's website, substances to be reviewed include chemicals in industrial and consumer products like 1-amino-2,4-dibromoanthraquinone, coconut diethanolamide, and methyl isobutyl ketone; food contaminants such as benzophenone, methyleugenol, and 4-methylimidazole; and water chlorination by products bromochloroacetic acid and dibromoacetonitrile. More information for the list of substances nominated for review by IARC is available online.

New York Sustainability And Green Procurement Advisory Council Drafting Recommendations For FY 2010-11: The Sustainability and Green Procurement Advisory Council (Advisory Council) of the New York Interagency Committee on Sustainability and Green Procurement (Interagency Committee) is in the process of drafting recommendations for inclusion in the annual report required under Governor David Paterson's 2008 Executive Order (EO) directing state agencies, public authorities, and public benefit corporations to buy environmentally friendly products. In September 2009, the Advisory Council voted 9-1 to recommend adoption of a Green Procurement Chemical Avoidance List, which would include approximately 94 substances: persistent, bioaccumulative, and toxic (PBT) chemicals found in EPA's Waste Minimization Priority List; carcinogens listed in the National Toxicology Program's Report on Carcinogens as substances "known or reasonably anticipated to be a human carcinogen"; polybrominated diphenylethers (PBDE) banned by New York State law (octa and penta) and classified as a possible human carcinogen by EPA (deca); BPA, "as a growing number of governments and companies are taking action to phase out the use of BPA due to significant weight of evidence that shows environmental and health risks"; and perfluorinated compounds, "as a growing number of governments and companies are taking action to phase out the use of such compounds due to significant weight of evidence that shows environmental and health risks."

The Avoidance List is available online. The Advisory Council's draft recommendations for implementing the EO in fiscal year 2010-11 do not specifically reference the Green Procurement Chemical Avoidance List. The draft recommendations include, among others, (1) assign full time sustainability coordinators and provide resources for their support; (2) implement recommendations by the State Comptroller to ensure the success of EO 4; (3) invest in trainings that allow for face-to-face interaction and collaboration; (4) design trainings to enhance participation and transferability; (5) involve unions in green cleaning training efforts; and (6) identify barriers and challenges to effective implementation.

The Advisory Council anticipates
 

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