Monthly Update for February 2013
EPA Issues Toxics Release Inventory Program Data: On January 16, 2013, the U.S. Environmental Protection Agency (EPA) issued the Toxics Release Inventory (TRI) data for 2011, revealing the releases declined 8 percent from 2010, primarily due to decreases in hazardous air pollutant (HAP) emissions. Total releases of chemicals increased for the second year in a row. The TRI program collects information on certain toxic chemical releases to the air, water, and land, as well as information on waste management and pollution prevention activities by facilities across the country. The 2011 TRI data show that 4.09 billion pounds of toxic chemicals were disposed of or released into the environment (i.e., air, water, or land), an 8 percent increase from 2010. The difference is due to increases in land disposal at metal mines, which typically involve large facilities handling large volumes of material. In this sector, even a small change in the chemical composition of the ore being mined, which EPA understands is one of the asserted reasons for the increase in total reported releases, can lead to big changes in the amount of toxic chemicals reported nationally. More on the 2011 TRI analysis and TRI web-based tools is available online. More on facility efforts to reduce toxic chemical releases is available online. More on EPA’s TRI mobile application, myRTK, is available online.
EPA Proposed Significant New Use Rules On Certain Chemical Substances: On January 23, 2013, EPA proposed significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for four perfluorinated chemical substances which were the subject of premanufacture notices (PMN). 78 Fed. Reg. 4806. The rule would require persons who intend to manufacture, import, or process any of the chemical substances 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. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit the activity before it occurs. Of the four chemicals, three are known under a generic category name as “partially fluorinated alcohol substituted glycols,” with PMN numbers P-10-58, P-10-59, and P-10-60. According to the PMNs EPA received and reviewed for P-10-58 and P-10-59, the two compounds would be used only to make the third compound P-10-60, a “surface active agent.” After reviewing the PMNs, EPA issued a consent order to DuPont to manage concerns it had about the possibility that these three chemicals might degrade into compounds that would persist in the environment, bioaccumulate, and be toxic to people or wildlife. The fourth chemical is pentane, 1,1,1,2,3,3- hexafluoro-4-(1,1,2,3,3,3-hexafluoropropoxy), Chemical Abstract Service (CAS) No. 870778-34-0, P-07-204, which EPA reviewed as a heat transfer fluid. Based on analogous chemicals, EPA stated that it was concerned about potential neurotoxicity and liver problems that might result from exposure to pentane, 1,1,1,2,3,3- hexafluoro-4-(1,1,2,3,3,3-hexafluoropropoxy). The original manufacturer amended its PMN to address EPA’s concerns, so EPA allowed the chemical to go into production without a consent order. Comments on EPA’s proposed SNURs are due February 22, 2013.
NTP Issues Draft Report On Carcinogens Monographs For 1-Bromopropane And Cumene: On January 22, 2013, the National Toxicology Program (NTP) issued the Draft Report on Carcinogens (RoC) Monographs for 1-bromopropane and cumene. 78 Fed. Reg. 4419. These documents were prepared by the Office of the Report on Carcinogens (ORoC), Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS). 1-Bromopropane (CASRN 106-94-5) is a brominated hydrocarbon that is currently used as a solvent in a variety of industrial and commercial applications. It is used as a solvent cleaner to degrease electronics, precision optics, and metals, as a solvent vehicle in industries that use aerosolized adhesives (e.g., foam cushion manufacturing), as a spot remover in the textile industry, and as a solvent in the dry cleaning industry. Additional information about the review of 1-bromopropane for the RoC is available online. Cumene (CASRN 98-82-8, isopropylbenzene) is an alkylated benzene found in fossil fuels, such as blended gasoline and kerosene, and products of incomplete combustion. It is a high production volume chemical in the United States with the majority of its use in the synthesis of acetone and phenol. Additional information about the review of cumene for the RoC is available online. A meeting on the report is scheduled for March 21-22, 2013. Comments on the report are due March 7, 2013.
EPA Issues NOIC Seeking Ban Of 12 D-Con Mouse And Rat Control Products: On February 5, 2013, EPA announced that it will issue a final notice of intent to cancel (NOIC) the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registrations for the 12 D-Con mouse and rat control products produced by Reckitt Benckiser Inc. (Reckitt). 78 Fed. Reg. 8123. This notice is intended to effectuate a Risk Mitigation Decision for rodenticides issued by EPA on May 28, 2008. EPA contends that these cancellations are necessary because “these products fail to comply with current EPA safety standards.” EPA will publish the final NOIC in the Federal Register and post it in the docket available online. More information is available online.
National Academies Set To Meet To Review Styrene And Formaldehyde: The National Academies has announced the first meetings of new committees to review the classifications of styrene and formaldehyde in the 12th RoC. The Styrene Committee will hold a closed, organizational teleconference February 19, 2013 followed by its first face-to-face meeting March 19, 2013, a portion of which will be open to the public. More information is available online. The Formaldehyde Committee will hold a closed, organizational teleconference February 20, 2013, followed by its first face-to-face meeting March 19, 2013, a portion of which will be open to the public. More information is available online. The National Academies convened both committees in response to a Congressional directive. The report that accompanied the Omnibus Appropriations Bill for fiscal year (FY) 2012, Pub. L. No. 112-74, provided the Department of Health and Human Services (HHS) with $1 million to have the National Academies peer review HHS’s classifications of formaldehyde as a known human carcinogen and styrene as a reasonably anticipated human carcinogen. NTP released that report June 10, 2011.
EPA Releases CDR Information: On February 11, 2013, EPA released the 2012 Chemical Data Reporting (CDR) information on more than 7,600 chemicals in commerce. The CDR database (recently renamed from Inventory Update Rule (IUR)) contains use and exposure information on chemicals used in the United States. In the August 2012 reporting cycle, for the first time, EPA required companies to substantiate confidentiality and submittal reports electronically. The CDR rule requires companies that manufacture or import chemicals to report manufacturing and import data every four years when site-specific production volume exceeds 25,000 pounds. This report is for calendar year 2011. According to EPA, it received reports on 7,674 chemicals, including 354 that were reported as used in children’s products. 1,704 chemicals were reported as used in consumer products and 3,073 were used in commercial applications or products. The remaining chemicals reported were for industrial use only. More information on the CDR data, including fact sheets, is available online.
EPA Issues Chlorpyrifos Assessment Possibly Representing Model For Addressing Spray Drift: On February 6, 2013, EPA released its preliminary volatilization assessment for the registration review of chlorpyrifos. 76 Fed. Reg. 8522. In a letter to the Natural Resources Defense Council (NRDC) and to the Pesticide Action Network North America (PANNA) dated January 25, 2013, updating these groups on EPA’s response to their September 12, 2007, joint petition regarding chlorpyrifos, EPA stated that “[t]his assessment represents a significant advancement in the evaluation of pesticide risks, as it will be the first probabilistic assessment of the risks posed by the post-application volatilization of a semi-volatile pesticide.” EPA further stated that it is “critical to involve the public in the development of this assessment before it is finalized,” given “the groundbreaking nature of the new assessment and its potential for use in guiding additional risk mitigation.” The implications of the draft assessment and possible regulatory pathways forward could be significant, particularly with regard to EPA’s potential pathway forward to addressing spray drift. More information is available online.
EPA Issues Final Rule On Human Subject Testing: On February 14, 2013, EPA issued final amendments to the portions of its rules for the protection of human subjects of research applying to third parties who conduct or support research with pesticides involving intentional exposure of human subjects and to persons who submit the results of human research with pesticides to EPA. 78 Fed. Reg. 10538. The amendments broaden the applicability of the rules to cover human testing with pesticides submitted to EPA under any regulatory statute it administers. The amendments disallow participation in third-party pesticide studies by subjects who cannot consent for themselves. Finally, the amendments identify specific considerations to be addressed in EPA science and ethics reviews of proposed and completed human research with pesticides, drawn from the recommendations of the National Academy of Sciences (NAS). The amendments make no changes to the current Federal Policy for the Protection of Human Subjects (the Common Rule), which governs research with human subjects conducted or supported by EPA and many other federal departments and agencies. This rule is effective April 15, 2013.
EPA Solicits 2013 Presidential Green Chemistry Challenge Award Nominations: On January 23, 2013, EPA announced that it is soliciting nominations for the 2013 Presidential Green Chemistry Challenge Award. Green chemistry is the design of chemical products and processes that reduce or eliminate the use of generation of hazardous substances. Green chemistry applies across the lifecycle of a chemical product, including its design, manufacture, use, and ultimate disposal. Green chemistry is also known as sustainable chemistry. The deadline for nominations submittal is April 30, 2013.
DTSC Releases Revised Proposed Safer Consumer Products Regulations: On January 30, 2013, the California Department of Toxic Substances Control (DTSC) released revised proposed Safer Consumer Products Regulations (Revised Proposed Regulations). The Revised Proposed Regulations are subject to a 30-day comment period, ending February 28, 2013. Memoranda providing background information are available online. The Revised Proposed Regulations are available online. More information is available online.
Inaugural Address Highlights Action To Halt Climate Change: President Obama made addressing climate change prominent policy vow in his second Inaugural Address stating: “We will respond to the threat of climate change, knowing that failure to do so would betray our children and future generations. Some may still deny the overwhelming judgment of science, but none can avoid the devastating impact of raging fires, and crippling drought, and more powerful storms.” The President’s vow is likely to set in motion an aggressive campaign that will draw upon regulatory action and other executive powers that will sidestep Congressional opposition. During his first term, President Obama failed to win passage of climate change legislation. It appears that he has learned from this, and his second term will focus on administrative actions he can take to reduce emissions of greenhouse gases (GHG). EPA’s forthcoming regulations limiting emissions from coal-fired utilities are likely to be a centerpiece of President Obama’s campaign, coupled with new energy efficiency standards for home appliances and buildings.
In the wake of the climate change statement in the Inaugural Address, Democratic lawmakers on January 24, 2013, announced in a letter to President Obama that they had formed a bicameral Task Force on Climate Change. The Task Force is to be chaired by Senator Sheldon Whitehouse (D-RI), Chair of the Senate Environment and Public Works (EPW) Subcommittee on Oversight; and Representative Henry Waxman (D-CA), Ranking Member of the House Energy and Commerce Committee. The lawmakers pledged to do “everything in our power to help you and Congress meet the moral imperative of protecting our nation from extreme climate change.” In the letter, they detailed three immediate actions they recommend President Obama take through executive action: detail specific steps federal agencies will take to ensure that U.S. emissions of heat-trapping gases are reduced by at least 17 percent below 2005 levels by the year 2020; accelerate federal investments in clean energy technology; and develop a strategy for protecting vulnerable regions of the nation from the worst effects of climate change. On January 31, 2013, the Task Force urged more than 300 businesses, environmental groups, and other organizations to offer ideas for legislation and to suggest actions President Obama can take using executive authority through EPA and other federal agencies. The Task Force’s letter also asks for specific legislative proposals that Congress could enact in a climate bill to strengthen the ability of federal agencies to prevent and respond to climate impacts.
President Obama Vows Action On Climate Change In State Of The Union Address: Continuing the refrain of combating global warming he introduced in his Inaugural Address, in his State of the Union address on February 12, 2013, President Obama promised to do more to blunt the impacts of climate change. He said that “Superstorm” Sandy, wildfires, a trend of increasing temperatures, and a severe drought are evidence of global warming. He urged lawmakers to pursue bipartisan climate change legislation. If Congress fails to act, however, the President promised that he would do so. “I will direct my cabinet to come up with executive actions we can take, now and in the future, to reduce pollution, prepare our communities for the consequences of climate change, and speed the transition to more sustainable sources of energy,” he vowed.
EPA Issues Final Rule On Identification Of Non-Hazardous Secondary Materials That Are Solid Wastes: On February 7, 2013, EPA issued a final rule revising Clean Air Act (CAA) standards for boilers and certain solid waste incinerators, originally promulgated in March 2011. 78 Fed. Reg. 9112. EPA re-examined the 2011 Identification of Non-Hazardous Secondary Material (NHSM) final rule in 40 C.F.R. Part 241 and amended/clarified certain issues on which EPA has received new information, as well as specific targeted revisions to allow implementation of the rule as EPA originally intended. EPA issued in final revisions to three definitions: “clean cellulosic biomass,” “contaminants,” and “established tire collection programs.” EPA also issued in final a revised definition of “resinated wood.” EPA issued a revised definition of “clean cellulosic biomass” that: makes clear that the list of biomass materials are examples within the definition and is not intended to be an exhaustive list; and provides a more comprehensive list of clean cellulosic biomass to guide the regulated community. Specifically, the following additional materials are included within the definition of biomass — agricultural derived biomass, other crop residues (including vines, orchard trees, hulls, and seeds), and other biomass crops used for the production of cellulosic biofuels, hogged fuel, untreated wood pallets, wood pellets, and wood debris from urban areas. EPA also issued a revised definition of “contaminants” to clarify what constituents will be considered contaminants for the purposes of the contaminant legitimacy criterion. Revisions include: the replacement of a reference to “any constituent that will result in emissions” with a specific list of constituents to be considered as contaminants based on their status as a precursor to air emissions; the removal from the definition of specific CAA Sections 112(b) and 129(a)(4) pollutants that are not expected to be found in any NHSM or are adequately covered elsewhere in the definition; and the removal of the phrase “including those constituents that could generate products of incomplete combustion” from the definition. EPA issued a revised definition of “resinated wood” that includes additional materials to be more representative of the universe of resinated wood residuals that are currently used as fuels throughout the wood product manufacturing process. EPA issued a revised contaminant legitimacy criterion for NHSMs used as fuels to provide additional details on how contaminant comparisons between NHSMs and traditional fuels may be made. In preamble text, EPA stated that it received information regarding other NHSMs that are good candidates for a categorical listing in a future rulemaking. These include: paper recycling residuals (including old corrugated cardboard (OCC) rejects); and construction and demolition (C&D) wood processed pursuant to best practices and produced and managed under the oversight of a comprehensive collection system or contractual arrangement. In addition, EPA noted that it had received information related to creosote-treated railroad ties and indicated areas where new information from the regulated community is needed and if such additional information provides support for a categorical listing, that EPA would also address this NHSM in a future rulemaking. A more detailed memorandum is available online.
GAO Updates High-Risk List: On February 14, 2013, the Government Accountability Office (GAO) issued a report, High-Risk Series: An Update, adding to its February 2011 list of 30 high-risk areas. In the updated report, GAO has added the government’s financial risk from climate change as an area of high-risk to the federal government. According to GAO, climate change creates “significant financial risks for the federal government” and the government needs a “government wide strategic approach with strong leadership to manage related risks.” The report is updated every two years to assist in setting federal priorities. EPA’s process for assessing and controlling the risk from “toxic chemicals” remains a high risk. The GAO report is available online.
Norway Requires Information On Norwegian Product Register Chemicals In Nanoform: On January 9, 2013, the Norwegian Climate and Pollution Agency (Klif) posted a notice concerning the annual update of information and mandatory reporting of quantities for chemicals for 2012 to the Norwegian Product Register. The Product Register is the central register for chemical products in Norway, and there are currently approximately 25,000 products registered. According to Klif’s notice, changes include adding a “NANO box” that registrants should mark if the chemical contains nanomaterials. The January 7, 2013, letter sent to registrants states:
Physical data that may be of significance when assessing the dangerous properties of chemicals must be declared under section 21 of the Norwegian Regulations relating to classification and labelling of dangerous chemicals. Details are given in guidelines on declaration. The definition of nano materials is given in the recommendation of the Commission by 18 October 2011. Registration of substances in nano form in the Product Register will provide better knowledge about where and how nano materials are used. The information will be used by the authorities in their work to protect human health and the environment.
For all your mandatory declared chemicals we ask you to provide information that is already known by the producer about substances on nano scale. This means that if your chemical contains a substance/substances in nano form, you should mark this in the appropriate box on the enclosed list. In addition you have to identify which constituent that is in nano form in the same box. During 2013 you will have to update the composition for all your mandatorily declared chemicals that contain substances in nano form.
Court Hears Oral Arguments In Case Challenging Conditional Nanosilver Registration: Oral arguments were held on January 16, 2013, in the NRDC’s case challenging EPA’s conditional registration of HeiQ AGS-20, a nanosilver product. NRDC filed suit on January 26, 2012, in the U.S. Court of Appeals for the Ninth Circuit (California). During oral arguments, EPA maintained that NRDC lacks standing to challenge the conditional registration. The judges appeared to reject EPA’s argument, suggesting that NRDC could prevail because of the low bar for establishing standing to challenge a rulemaking. The judges seemed less persuaded by NRDC’s argument that EPA erred in choosing three-year-olds rather than nine-month-olds as the most vulnerable subpopulation on which to base risk values. According to NRDC, EPA should have used infants, who are more likely to chew on textiles and could have higher exposures. EPA responded that EPA has a long-standing practice of using three-year-olds in risk assessments with similar exposure patterns to AGS-20, and that its use of three-year-olds was supported by leaching studies. NRDC further argued that EPA failed to consider the risk of aggregate exposures from other nanosilver products on the market. EPA responded that it applied uncertainty factors to account for data gaps and that HeiQ must submit more data to obtain a full registration. The oral arguments are available online.
NIOSH Seeks Comment For Updating Its 2013-2016 Nanotechnology Strategic Plan: On January 18, 2013, the National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice seeking comment on the types of hazard identification and risk management research to consider in updating its fiscal years 2013-2016 nanotechnology strategic plan. 78 Fed. Reg. 4150. NIOSH states that it wants to “build on the accomplishments of ongoing research” to “develop strategic research goals and objectives for nanotechnology occupational safety and health research through 2016.” NIOSH previously identified ten critical research areas for nanotechnology research and communication: (1) toxicity and internal dose; (2) measurement methods; (3) exposure assessment; (4) epidemiology and surveillance; (5) risk assessment; (6) engineering controls and personal protective equipment; (7) fire and explosion safety; (8) recommendations and guidance; (9) global collaborations; and (10) applications. According to the notice, NIOSH is considering focusing the research goals on five key objectives: (1) increase understanding of new hazards and related health risks to nanomaterial workers; (2) expand understanding of the initial hazard findings on engineered nanomaterials; (3) support the creation of guidance materials to inform nanomaterial workers, employers, health professionals, regulatory agencies, and decision-makers about hazards, risks, and risk management approaches; (4) support epidemiologic studies for nanomaterial workers, including medical and exposure studies; and (5) assess and promote national adherence with risk management guidance. NIOSH requests public input to address the basis or rationale for priorities that NIOSH should give for studies of toxicity evaluation and/or workplace exposure characterization for engineered nanoparticles, and what rationale can be provided for recommending needs and types of technical and educational guidance materials. Comments are due March 19, 2013.
Study Evaluates Antimicrobials, Including Nanosilver, For Textile Applications: Environment International recently posted online an article entitled “Comparative evaluation of antimicrobials for textile applications.” The authors provide an overview of the main compounds currently used — triclosan, silane quaternary ammonium compounds, zinc pyrithione, and silver-based compounds, including nanosilver. The authors evaluated scientific publications, market data, and regulatory documents to consider the potential effects of antimicrobials on the environment and on human health, taking life cycle perspectives into account. The authors summarize the characteristics of each compound according to technical, environmental, and human health criteria. The authors conclude that the application rates of the antimicrobials used are an important parameter, “with treatments requiring lower dosage rates offering clear benefits in terms of less active substance required to achieve the functionality.” While the authors concluded that “each antimicrobial technology has specific risks and benefits that should be taken into account in evaluating the suitability of different antimicrobial products,” the abstract states: “The results also indicated that nanoscale silver and silver salts that achieve functionality with very low application rates offer clear potential benefits for textile use.” The project was partially funded by HeiQ Materials AG, which obtained EPA’s first conditional registration for nanosilver. The article is available online.
OSHA Publishes Fact Sheet On Working Safely With Nanomaterials: The Occupational Safety and Health Administration (OSHA) recently published a fact sheet entitled Working Safely with Nanomaterials. OSHA notes that workers who use nanotechnology in research or production processes may be exposed to nanomaterials through inhalation, skin contact, or ingestion. OSHA intends the fact sheet to provide “basic information to workers and employers on the most current understanding of potential hazards associated with this rapidly-developing technology and highlight measures to control exposure to nanomaterials in the workplace.” According to the fact sheet, information and training provided to workers should include:
- Identification of nanomaterials the employer uses and the processes in which they are used;
- Results from any exposure assessments conducted at the work site;
- Identification of engineering and administrative controls and personal protective equipment (PPE) to reduce exposure to nanomaterials;
- The use and limitations of PPE; and
- Emergency measures to take in the event of a nanomaterial spill or release.
OSHA states that there are few occupational exposure limits specific to nanomaterials. According to OSHA, because certain nanoparticles may be more hazardous than larger particles of the same substance, existing occupational exposure limits for a substance may not provide adequate protection from nanoparticles of the same substance. OSHA notes the following specific exposure limits:
- OSHA recommends that worker exposure to respirable carbon nanotubes and carbon nanofibers not exceed 7.0 micrograms per cubic meter (µg/m3) as an 8-hour time-weighted average, based on the NIOSH proposed Recommended Exposure Limit (REL); and
- OSHA recommends that worker exposure to nanoscale particles of titanium dioxide (TiO2) not exceed NIOSH’s 0.3 milligrams per cubic meter (mg/m3) REL. By contrast, NIOSH’s REL for fine-sized TiO2 (particle size greater than 100 nm) is 2.4 mg/m3.
OSHA suggests that, because exposure limits for other nanomaterials do not exist yet, employers should minimize worker exposure by using the hazard control measures and best practices identified in the fact sheet and in the references noted. The fact sheet is available online.
EC Concludes REACH Review, Will Assess Options Concerning Nanomaterials: The European Commission (EC) announced on February 5, 2013, that it completed its five-year review of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. The pre-publication version of the EC’s report states that the EC “will make an impact assessment of relevant regulatory options, in particular possible amendments of REACH Annexes, to ensure further clarity on how nanomaterials are addressed and safety demonstrated in registration dossiers. If appropriate the Commission will come forward with a draft implementing act by December 2013.” The pre-publication version of the staff working paper specifically recommends that, if REACH needs amending “for other reasons,” then “consideration should be given to the introduction of the definition of a nanomaterial in line with Recommendation 2011/696/EU.” The EC’s report is available online. The Staff Working Paper is available online.
ECHA Recommends Ten SVHCs For Authorization: The European Chemicals Agency (ECHA) announced on January 17, 2013, that it recommended ten substances of very high concern (SVHC) for authorization. According to ECHA, the recommended chemicals are classified as carcinogenic or toxic to reproduction and are used in applications where there is potential for worker exposure. For each substance recommended for inclusion in Annex XIV, a deadline is suggested after which companies will only be able to use it within the European Union (EU) if an authorization has been granted. The final decision on the inclusion of the substances in Annex XIV and on their sunset dates will be made by the EC, in collaboration with Member States and the European Parliament. The ten SVHCs and examples of their uses in the scope of authorization are listed below:
|Substance name and SVHC property||Uses in the scope of authorization (examples)|
|Formaldehyde, oligomeric reaction products with aniline (technical MDA) (carcinogenic)||Hardener for epoxy resins; curing agent for polymers|
|Arsenic acid (carcinogenic)||Used to modify properties of glass and in the production of printed circuit boards|
|Dichromium tris(chromate) (carcinogenic)||Anti-corrosion surface treatments of steel and aluminium in the construction and the aeronautic sectors|
|Strontium chromate (carcinogenic)||Anti-corrosion coatings in the aeronautic/aerospace, coil coating and vehicle coating sectors|
|Potassium hydroxyoctaoxodi-zincatedichromate (carcinogenic)||Anti-corrosion coatings in the aeronautic/aerospace and vehicle coating sectors|
|Pentazinc chromate octahydroxide (carcinogenic)||Anti-corrosion coatings in the vehicle coating and the aeronautic/aerospace sectors|
|Bis(2-methoxyethyl) ether (Diglyme) (toxic for reproduction)||Primarily used as a reaction solvent or process chemical in distillation applications; further in batteries and in the production of plastics|
|N,N-dimethylacetamide (DMAC) (toxic for reproduction)||Solvent in synthesis, the production of synthetic fibres, in industrial coatings, paint strippers, insulation paper, films and membranes|
|1,2-dichloroethane (EDC) (carcinogenic)||Solvent in the manufacture of fine chemicals and pharmaceuticals and in mixtures for biochemical applications|
|2,2′-dichloro-4,4′-methylenedianiline (MOCA) (carcinogenic)||Curing agent in resins and in the production of polymer articles|
More information is available online.
EC Issues REACH Review: On February 5, 2013, the EC published its review of the REACH regulation (see related item above in Nanotechnology section). The report, available online, concludes that “REACH functions well and delivers on all objectives that at present can be assessed,” and no substantial changes should be proposed in the “interest of ensuring legislative stability and predictability.” Steps will be taken to reduce the costs of REACH compliance for small and medium sized enterprises (SME), to encourage REACH registrants to improve the quality of their registration dossiers, and to promote coordinated enforcement of REACH in EU Member States. An accompanying Staff Working Document, available online, indicates that such an assessment is required as although “experience with existing registration dossiers shows that the basic REACH chemical assessment framework is applicable and in principle can be used to demonstrate the safe use of nanomaterials, there is a need for more clarity in the registration dossiers on how the safe use of nanoforms is ensured.” A call was made “to review the requirements relation to registration of low-tonnage substances” to see whether REACH needed to be amended to take them into account. A review of ECHA was also proposed. The Commission stated that it does not intend to propose any changes to the enacting terms of REACH. It concedes that some things need to be changed, but has concluded against it as it wishes to ensure “legislative stability and predictability” and believes that “REACH functions well and delivers on all objectives that at present can be assessed.” The REACH review is available online.
EC Issues Roadmap For SVHC Identification: On February 5, 2013, the EC issued a document, Roadmap for SVHCs Identification and Implementation of REACH Risk Management Measures From Now to 2020, which describes a total of 440 substance risk assessments as a “worst case estimation” to which “adequate resources” will need to be dedicated if it is to be achieved. Based on the document, it would appear that 55 substances per year will be risk-assessed, but the “mid-term objective” is to assess 80 substances by the end of 2014 because “in 2013, resources will be needed to prepare the implementation,” according to the document. The Roadmap for SVHCs Identification and Implementation of REACH Risk Management Measures From Now to 2020 is available online.
B2PAC, SCD-iBIO Form Alliance To Advance Commercialization Of Industrial Biotechnology: On February 14, 2013, the Biobased Products Advocacy Consortium (B2PAC), an affiliate of Bergeson & Campbell, P.C. (B&C), and the Society for the Commercial Development of Industrial Biotechnology (SCD-iBIO), an affiliate of the Society of Chemical Manufacturers & Affiliates (SOCMA), announced the formation of a new alliance to advance the commercialization of industrial biotechnology and biobased products. According to a recently released report from Lux Research, industrial biotechnology and biobased product development is experiencing a robust year in growth of 30%. Through a memorandum of understanding, B2PAC and SCD-iBIO have recognized the complementary nature of their missions and the benefit to the biobased chemical and industrial biotechnology communities of working cooperatively where appropriate. More information is available online.
EPA Announces Proposed 2013 Renewable Fuel Standards: On February 7, 2013, EPA proposed 2013 percentage standards for four fuel categories that are part of the Renewable Fuel Standard Program. 78 Fed. Reg. 9282. Under the Energy Independence and Security Act (EISA), the annual renewable fuel volume targets steadily increase to an overall level of 36 billion gallons in 2022. To meet this goal, EPA calculates a percentage-based standard, and, based on the standard, each refiner and importer determines the minimum volume of renewable fuel that it must ensure is used in its transportation fuel. The proposed 2013 overall volumes and standards are:
- Biomass-based diesel (1.28 billion gallons; 1.12 percent);
- Advanced biofuels (2.75 billion gallons; 1.60 percent);
- Cellulosic biofuels (14 million gallons; 0.008 percent); and
- Total renewable fuels (16.55 billion gallons; 9.63 percent).
EPA notes that, for 2013, it is proposing to implement EISA’s requirement to blend more than 1.35 billion gallons of renewable fuels over the amount mandated for 2012. Comments are due on or before March 25, 2013.
EPA Proposes Voluntary Quality Assurance Program: On January 31, 2013, EPA signed off on a proposed rule offering an alternative voluntary quality assurance program (QAP) to help assure compliance and minimize fraudulently procured Renewable Identification Numbers (RIN). Parties subject to the RFS demonstrate compliance with the renewable fuel volume standards in one of two ways: by acquiring the required volumes of renewable fuels together with the associated RINs, which are assigned by the renewable fuel producer or importer to each batch of renewable fuel produced or imported, or by acquiring only the RINs without the associated fuel. A validly generated RIN demonstrates that a certain volume of qualifying renewable fuel was produced or imported. The RFS program also includes provisions stipulating the conditions under which RINs are invalid, the potential liability carried by a party that transfers or uses an invalid RIN, and how invalid RINs must be treated. According to EPA, the basis of EPA’s treatment of invalid RINs is the concept of “buyer beware,” in which all regulated parties are urged to take steps to verify that the RINs they acquire are valid, and that all parties in the value chain are liable for transferring or using invalid RINs. EPA has proposed a new voluntary third-party QAP for verifying RIN validity that regulated parties may exercise as an alternative to the “buyer beware” approach. As was widely reported, last year EPA reached a settlement with approximately 30 companies for allegedly purchasing fraudulent RINs. The settlement required gasoline and fuel refiners and importers to pay millions of dollars in penalties for using RINs that were fraudulently generated. EPA believes that the consequence of such fraudulent RIN purchases is that smaller renewable fuel producers have difficulty selling their RINs. EPA has been seeking ways to prevent this problem, which prompted the new voluntary alternative approaches. EPA has proposed to establish a voluntary third-party QAP to verify the legitimacy of RINs. Under the proposal, if certain conditions are satisfied, the buyer would be able to assert an affirmative defense that would preclude liability for penalties otherwise associated with the purchase or transfer of invalid RINs. Entities may select one of two options for RIN verification through a QAP. These options would provide, according to EPA, flexibility in how parties choose to manage the risk of transferring or using invalid RINs and costs. In this regard, EPA is proposing:
- Minimum requirements for QAPs, including such things as verification of type of feedstocks, verification that volumes produced are consistent with amount of feedstocks processed, and verification that RINs generated are appropriately categorized and match the volumes produced.
- Qualifications for independent third-party auditors.
- Replacement instruments or other mechanisms that would provide assurance that invalid RINs are replaced with valid RINs.
- Requirements for audits of renewable fuel production facilities, including minimum frequency, site visits, review of records, and reporting.
- Conditions under which a regulated party could assert an affirmative defense to civil liability for transferring or using an invalid RIN.
- Identification of the party or parties who are responsible for replacing invalid RINs with valid RINs and the timing of such replacement.
- Changes to the EPA-Moderated Transaction System (EMTS) that would accommodate the QAP
EPA proposes that the QAP option would be applicable at the beginning of 2013. EPA also has proposed modifications to the exporter provisions of the RFS program. These modifications would ensure that an appropriate number and type of RINs are retired whenever renewable fuel is exported. Finally, EPA has proposed new provisions to address RINs that become invalid downstream of a renewable fuel producer.
Court Vacates 2012 Cellulosic Biofuel Requirements: On January 25, 2013, the U.S. Court of Appeals for the District of Columbia Circuit vacated the EPA’s 2012 cellulosic biofuel requirements under the renewable fuel standard. American Petroleum Institute v. EPA, D.C. Cir. No. 12-1139. In its January 2012 final rule, EPA projected that 8.65 million gallons of cellulosic biofuel would be produced in 2012, and determined that a reduction in the volume of total advanced biofuels was unnecessary because other kinds of advanced biofuels could make up for the shortfall. The American Petroleum Institute (API) filed suit, challenging EPA’s 2012 projection for cellulosic biofuel and its refusal to reduce the volume of total advanced biofuels for 2012. While the court rejected API’s argument that EPA failed to justify its determination not to reduce the applicable advanced biofuels volume, the three-judge panel unanimously agreed that “because EPA’s methodology for making its cellulosic biofuel projection did not take neutral aim at accuracy, it was an unreasonable exercise of agency discretion.” The court vacated that aspect of the 2012 rule and remanded it to EPA. An EPA spokesperson stated that EPA is still reviewing the court’s decision. The court’s decision is available online.
FDA Issues CGMP Requirements For Combination Products: On January 22, 2013, the Food and Drug Administration (FDA) published final Current Good Manufacturing Practice Requirements for Combination Products (CGMP). 78 Fed. Reg. 4307. In stating the rationale for the rule, FDA noted that the constituent parts of a combination product retain their regulatory status (as a drug or device, for example) after they are combined, and so, the CGMP requirements that apply to each of the constituent parts continue to apply when they are combined to make combination products. FDA indicated, however, that it had not issued specific regulations clarifying the applicability of the several possible CGMP requirements (drugs, devices, biologics, etc.) to combination products, and it stated in the final rule that the absence of clear requirements for combination products could result in inconsistent or differing application of the various CGMP requirements applicable to the constituent parts, which could affect product safety and the public health. In addition, the absence of clear requirements could lead some manufacturers to develop and document manufacturing practices that are redundant and overly burdensome. In terms of CGMP compliance, FDA differentiated between two situations. If the constituent parts of a combination product are each subject only to the CGMP regulations applicable to that type of constituent part (e.g., drug or device) or if the constituent parts are manufactured and marketed separately, as may be the case for constituent parts of cross-labeled combination products, then they remain separate for purposes of applying the CGMP regulations. In the second case, however, it is not possible for the single-entity and co-packaged combination products to remain separate, and, a CGMP operating system must seek to have a system that satisfies the CGMP regulations applicable to one constituent part and also satisfy most of the CGMP requirements applicable to the other constituent part. Based on this assessment, FDA is offering two options for demonstrating compliance with the CGMP requirements applicable to a co-packaged or single-entity combination product. These options are either to demonstrate compliance with the specifics of all CGMP regulations applicable to each of the constituent parts included in the combination product, or to demonstrate compliance with the specifics of either the drug CGMPs or the Quality System (QS) regulation for devices, rather than both, when the combination contains both a drug and a device, under certain conditions. These conditions include demonstrating compliance with specified provisions from the other of these two sets of CGMP requirements. In addition, for a combination product that included a biological product, the CGMPs requirements for biological products would apply, and, for a combination product that included any human cell, tissue, and cellular and tissue-based products (HCT/Ps), the regulations in Part 1271 would apply. The rule is effective on July 22, 2013.
Senator Lautenberg Introduces Bills Requiring High-Risk Facilities To Implement Inherently Safer Technologies: Senator Frank Lautenberg (D-NJ) on January 23, 2013, introduced two bills seeking to require certain high-risk facilities to implement measures — including so-called inherently safer technologies (IST) — to protect them from terrorist attacks. The Secure Water Facilities Act (S. 67) and the Secure Chemical Facilities Act (S. 68) would require high-risk drinking water and wastewater treatment plants and chemical facilities to assess their vulnerability to attack, develop a plan to address those vulnerabilities and respond to an emergency, and provide worker training to carry out the plan. The bills also would require facilities using certain chemicals to evaluate whether they could reduce the consequences of an attack by, for example, using ISTs. A facility would be required to implement ISTs if it has been classified as one of the highest-risk facilities, implementation of safer measures is feasible, and implementation would not increase risk overall by shifting risk to another location. The bills would also require the protection of sensitive security information from disclosure, allow communities to have a role in ensuring local facilities comply with these regulations, and authorize grants to help defray the cost of implementing the legislation. The bills are similar to legislation Senator Lautenberg introduced in the last Congress. The legislation faces a headwind of opposition from the chemical industry, and thus is unlikely to be passed.
Senator Lautenberg Steps Down As Chair Of EPW Toxics Subcommittee: Senator Frank Lautenberg (D-NJ) has stepped down as Chair of the EPW Superfund, Toxics and Environmental Health Subcommittee. It is unclear what this holds in store for TSCA legislative reform, as Senator Lautenberg was the author of the most recent attempts to amend the law. The Subcommittee changes were announced on February 12, 2013, by EPW Chair Barbara Boxer (D-CA) and panel ranking member David Vitter (R-LA) in a press release announcing the updated Subcommittee memberships for the 113th Congress. Senator Tom Udall (D-NM) will now chair the Superfund, Toxics and Environmental Health panel. The full rosters for the EPW Subcommittees can be accessed online.
Senators Call On President Obama To Approve Keystone Pipeline: Fifty three U.S. Senators on January 23, 2013, sent a letter to President Obama urging him “to finish expeditiously the review process and approve” TransCanada Corporation’s proposed XL pipeline. The letter noted that Nebraska on January 22, 2013, approved a new route for the pipeline, and that the route avoids the Sand Hills. President Obama cited possible damage to Sand Hills by the pipeline when he rejected it last year. With Nebraska’s approval of the new route, the Senators — 9 Democrats and 44 Republicans — cautioned the President “not to move the goalposts as opponents of this project have pressed” him to do, and to approve the pipeline as quickly as possible.
House Science, Space, And Technology Committee Assigns Responsibilities For New Subcommittees: On January 23, 2013, members of the House Science, Space, and Technology Committee approved an organizational plan that delineates the areas of oversight for the Committee’s recently created Environment and Energy Subcommittees. The Environment Subcommittee, chaired by Andy Harris (R-MD), will have jurisdiction over federal climate research activities, research and development efforts at EPA, and other matters. The new Energy Subcommittee, chaired by Cynthia Lummis (R-WY), will oversee the Department of Energy’s (DOE) Office of Science, nuclear research and development, and related issues.
Senate Bills Seek To Limit Reach Of EPA: A package of bills introduced in the Senate on February 13, 2013, seeks to limit EPA’s regulatory reach and to penalize EPA for missing certain reporting deadlines. Introduced by Senator Mike Johanns (R-NE), the bills reflect the latest in a series of Republican attempts to rein in an EPA that GOP lawmakers say has over-reached its regulatory authority and that must be held accountable. Senator Johanns introduced four separate pieces of legislation to accomplish this aim. The first, S. 317, would require the EPA Inspector General to report to Congress twice yearly on EPA’s progress toward meeting certain reporting deadlines that the Senator said EPA routinely misses. This legislation is largely intended to ensure EPA timely publishes the semi-annual regulatory agenda in the Federal Register. Should EPA miss these deadlines, the second bill (S. 318) would cut EPA’s budget $20,000 per week until EPA meets the deadlines. The third bill (S. 319) would require EPA to provide adequate data, modeling, and support in the development of State Implementation Plans (SIP) under the CAA. The final bill in the package (S. 320) is intended to blunt EPA’s “extensive” use of guidance documents in lieu of regulations. The bill would require Congressional review of EPA guidance documents. Senator Johanns said he introduced the series of bills to increase transparency and responsiveness at EPA and because Nebraskans are frustrated by EPA’s actions.
Senate Bills Address Cancer And Disease Clusters: Senator Barbara Boxer (D-CA), Chair of the EPW Committee, on January 23, 2013, introduced with Senator Mike Crapo (R-ID) two pieces of legislation (S. 50, S. 53) to take federal action towards addressing cancer and disease clusters. S. 50 would direct EPA to investigate and address cancer and disease clusters, while S. 53 would authorize EPA to award grants to individuals impacted by disease clusters.
Water Advanced Technologies For Efficient Resource Use Act Of 2013: Representative Rush Holt (D-NJ) on January 3, 2013, introduced the Water Advanced Technologies for Efficient Resource Use Act of 2013 (H.R. 123). The bill would establish within EPA a “WaterSense” program to identify and promote water efficient products, buildings and landscapes, and services to reduce water use, conserve energy, and preserve water resources. It would also require federal agencies to purchase WaterSense products or services or a federal energy management program designated product through their procurement process. The bill also calls for financial incentives for consumer purchase and installation of residential water efficient products and services.
Legislation Seeks To Amend OSHA Reporting Of Occupational Injuries And Illnesses: OSHA’s regulations for the reporting of occupational injuries and illnesses would be altered under legislation introduced on January 4, 2013, by Representative Gene Green (D-TX). The bill (H.R. 170) would revise the regulations in 29 C.F.R. Part 1904 to require “site-controlling employers” to keep a site log for all recordable injuries and illnesses occurring among all employees on the particular site, whether such employees are employed directly by the site-controlling employer or are employed by contractors or temporary help or employee leasing services. The bill defines “site-controlling employer” to mean the employer that has primary control over the work on a particular work site and supervises the employees on a day-to-day basis on a particular work site. Congressman Green has introduced this legislation in the past four Congresses; it is unlikely to advance.
Clean Water Act Citizen Suits Would Be Limited Under House Bill: Representative Tom McClintock (R-CA) introduced a bill on January 4, 2013, that would amend the Clean Water Act to limit citizens suits against publicly owned treatment works (POTW). The bill (H.R. 202) would prohibit a citizen suit from being commenced against a POTW to enforce an effluent standard or limitation unless the POTW is in significant non-compliance. It also would protect from liability any POTW or POTW operator that unlawfully discharges a pollutant if the release was caused by an act of God, an act of war, or an act or omission of a third party other than an employee or agent of such person or one whose act or omission occurs in connection with a contractual relationship with such person. Under the bill, EPA would have to wait 60 days before issuing a civil penalty to a POTW. The bill would also extend the permit life for POTWs from 5 years to 15 years.
Common Sense Waiver Act Of 2013: Congressman William Owens (D-NY) on January 4, 2013, introduced a bill seeking to make demolitions of certain condemned properties exempt from asbestos abatement requirements under the CAA. The Common Sense Waiver Act of 2013 (H.R. 204) is a reintroduction of legislation from the 112th Congress that Congressman Owens authored in response to a situation involving an asbestos-contaminated building in Malone, New York. Congressman Owens was contacted by officials in the Village of Malone who expressed concern over a building in severe disrepair. The village sought to demolish the building, fearing it would collapse, but lacked sufficient funding to do so because of costs and regulations associated with demolishing a building that contains asbestos. As a result, village leadership sought financial assistance to demolish the building, and Congressman Owens reached out to EPA on their behalf. EPA responded that no such funding was available, but neither could they waive the expensive, asbestos-related regulations preventing Malone from demolishing the building themselves. The building subsequently collapsed, at which point EPA stepped in to assist with the cleanup. The Common Sense Waiver Act would give EPA flexibility to waive certain costly regulations governing the demolition of a building contaminated with asbestos. To qualify, a building must be condemned and have a reasonable expectation of structural failure.
Senate Bill Would Block U.S. Action On Climate Change: Senator David Vitter (R-LA) on January 28, 2013, introduced a bill that would prohibit EPA and the Obama Administration from regulating GHG emissions until China, India, and Russia implement similar reductions. The legislation (S. 163) states that neither EPA nor other federal agencies may regulate or implement regulations establishing emission limits on GHGs until an interagency certification is made that China, India, and Russia have implemented and enforced similar programs.
Bill Would Block EPA Funding for Climate Change: Legislation introduced on February 12, 2013, by Representative Ted Poe (R-TX) would prohibit funding for EPA to use to implement or enforce a cap-and-trade program for GHGs. The legislation (H.R. 621) was referred to the Energy and Commerce Committee and has garnered six co-sponsors.
House Resolution Introduced Opposing Carbon Tax: Claiming that any carbon tax intended to reduce emissions of GHGs would “increase the cost of everything,” Representative David McKinley (R-WV) on January 16, 2013, introduced a resolution (H. Con. Res. 8) that opposes the imposition of any carbon tax on fuel or electricity. The resolution is identical to one he introduced in November 2012. The resolution is unlikely to advance.
Senate Republicans Introduce Climate Change Resolution: On January 29, 2013, 18 Senate Republicans introduced a resolution (S. Con. Res. 4) stating that a carbon tax would hurt lower-income Americans already struggling under the “stagnating economy” and should be opposed. “t is the sense of Congress that a carbon tax would be detrimental to American families and businesses, and is not in the interest of the United States,” reads the resolution. The introduction of the resolution, sponsored chiefly by Senator David Vitter (R-LA), appears to reflect Republicans’ fear that President Obama will propose a tax on carbon usage, despite White House promises that it will not do so.
Senator Blumenthal Named Chair Of New Senate Oversight Subcommittee On Regulations: Senator Richard Blumenthal (D-CT) has been named Chair of a new Senate panel aimed at enforcing federal regulations. The Subcommittee on Oversight, Federal Rights and Agency Action will function as an arm of the Senate Judiciary Committee. The purpose of this new Subcommittee is to ensure that federal agencies follow and enforce the law — assuring protection of legal rights with effective remedies, Senator Blumenthal said. The Subcommittee will have purview over administrative practices for federal regulations, judicial review of actions by federal agencies, and government fraud and abuse. Senator Orrin Hatch (R-UT) will be the ranking member of the Subcommittee.
House Bill Would Place Moratorium On Mountaintop Mining: Legislation introduced in the house by John Yarmuth (D-KY) and Louise Slaughter (D-NY) would put a hold on all new permits for mountaintop removal coal mining. The hold would remain in effect while the Department of HHS studies the health impacts of mountaintop mining activities on adjacent communities. The Appalachian Community Health Emergency Act (H.R. 526) also would require the first comprehensive federal study on the health effects of mountaintop removal coal mining. Similar legislation was introduced last Congress, but did not advance.
Carbon Dioxide Emissions: On January 23, 2013, Senator David Vitter (R-LA) introduced S. 107, a measure to prohibit EPA Administrator or the head of any other federal agency from regulating carbon dioxide emissions until the Secretary of Commerce certifies that China, India, and Russia have initiated measures that require carbon dioxide emission reductions that are substantially similar to those proposed for the United States.
FIFRA Permits: On January 29, 2013, Senator Pat Roberts (R-KS) introduced S. 175, which would amend FIFRA to provide that no permit would be required for: the use of a pesticide that is registered or otherwise authorized for use under FIFRA; the use of a biological control organism for the prevention, control, or eradication of a plant pest or noxious weed that is in accordance with the Plant Protection Act; or the conduct of any other plant pest, noxious weed, or pest control activity conducted in accordance with the Plant Protection Act.
Nanotechnology Advancement: On January 23, 2013, Representative Michael Honda (D-CA) introduced H.R. 394, the Nanotechnology Advancement and New Opportunities Act. The bill directs the Secretary of Commerce, if $100 million is made available from the private sector for establishing a Nanomanufacturing Investment Partnership, to establish such a Partnership to provide funding for pre-commercial nanomanufacturing research and development projects. H.R. 394 would permit the Partnership to provide funding through direct investments in specified mechanisms designed to advance nanomanufacturing. It would further require return to the Partnership of amounts resulting from the commercialization of developed technologies. Other features would be the establishment of an advisory board to assist the Secretary in carrying out the Partnership, and the amendment of the Internal Revenue Code (IRC) to allow a tax credit for the purchase of qualified nanotechnology developer stock. The Honda measure would also authorize establishment within the Technology Administration of a grant program to support the establishment and development of incubators (entities affiliated with or housed in degree-granting institutions that provide space and coordinated and specialized services to certain entrepreneurial businesses and direct the National Science Foundation (NSF) to establish a Nanoscale Science and Engineering Center for the development of computer aided design tools for nanotechnology applications. Nanotechnology research grant programs would be established for a variety of uses. The Secretary of Energy (DOE) would address the need for clean, cheap, renewable energy; the EPA Administrator would address technologies for remediation of pollution and other environmental protection technologies; DHS would address the need for sensors and other materials related to homeland security needs; and (4) the Secretary of HHS would address health-related applications of nanotechnology. Among other provisions, the IRC would be amended to: allow a tax credit for nanotechnology education and training program expenses; and revise, for purposes of Hope and Lifetime Learning tax credits, the definition of “eligible educational institution” to include commercial nanotechnology training providers.
Other Bills Introduced: Several measures related to the Federal Food, Drug, and Cosmetic Act (FFDCA) were introduced in the first days of the new session. S. 214, a bill introduced by Senator Amy Klobuchar (D-MN), would prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market. Representative William Keating (D-MA) introduced H.R. 486, a bill to amend the Act to incentivize the development of abuse-deterrent drugs. S. 248, introduced by Senator Mark Begish (D-AK), would amend the Act to require labeling of genetically engineered fish. In addition to the Act, Representative Doc Hastings (R-WA) introduced H.R. 527 that would amend the Helium Act to complete the privatization of the federal helium reserve in a competitive market fashion that ensures stability in the helium markets while protecting the interests of American taxpayers.
Senate Bill Would Impose $20 Per Ton Carbon Fee: Senators Barbara Boxer (D-CA) and Bernie Sanders (I-VT) on February 14, 2013, introduced legislation that would impose a $20 per ton carbon fee to be paid largely by coal, oil, and gas producers. The Climate Protection Act of 2013 (S. 332) also includes provisions that would bolster EPA’s authority to regulate hydraulic fracturing.
President Obama Nominates CEO Of REI As Secretary Of The Interior: On February 6, 2013, President Obama nominated Sally Jewell, Chief Executive Officer (CEO) of retailer Recreational Equipment Inc. (REI) to serve as the next Secretary of the Interior. President Obama said that Ms. Jewell will balance the Department of the Interior (DOI) sometimes conflicting mandates to promote resource development and preserve the nation’s natural heritage. Ms. Jewell is a former oil company engineer who also had a 19-year career as a commercial banker before taking the reins of REI in 2005.
Negotiators Agree To Global Convention For Phase-out Of Mercury In Products: On January 19, 2013, agreement was reached on a new convention by negotiators from 140 countries that will lead to the global phase-out of mercury in a variety of products and processes over the next decade. The agreement, which was concluded after a dispute over financing, was acknowledged by negotiators and U.N. officials as a major achievement. The agreement, officially titled the Minamata Convention on Mercury, will be opened for signature at a diplomatic conference in Japan in October. The convention is named after the southern Japanese town where industrial dumping of mercury in a nearby bay more than half a century ago poisoned thousands of people and has still not been fully cleaned up. The convention will enter into force once 50 countries have ratified it. Officials predicted it would take three to four years to reach that threshold. The convention will require the phase-out of the manufacture, import, and export by 2020 of certain products that use mercury. Among the listed products are batteries (except for “button cell” batteries used in implantable medical devices), most switches and relays, certain types of compact fluorescent lamps, and mercury in cold cathode fluorescent lamps and external electrode fluorescent lamps. Also scheduled for phase-out by 2020 are mercury used in thermometers, barometers, and other non-electric measuring devices (except for high-precision instruments for which no mercury-free alternatives are available), cosmetics such as skin lightening soaps and creams with a mercury content above one part per million, and pesticides, biocides, and topical antiseptics. The convention will also require parties to “phase down” their use of mercury in dental fillings, or amalgams, and to adopt at least two of nine listed measures to achieve reduced use. In addition, mercury use in certain processes will eventually be eliminated, such as chlor-alkali production, for which a 2025 phase-out date was fixed after Brazil and Russia lobbied for additional time. An exception will allow continued use of mercury in vinyl chloride monomer, which is an input in the production of PVC plastic. China is one of the few countries with a coal-based VCM production industry in which mercury is used to spark the chemical reaction. The United Nations Environment Program’s (UNEP) Global Mercury Assessment 2013 is available online.
EPA Seeks Comments On National Enforcement Initiatives For FYs 2014-2016: On January 28, 2013, EPA solicited public comments and recommendations on national enforcement initiatives to be undertaken in FYs 2014-2016. 78 Fed. Reg. 5799. EPA selected these priority areas every three years in order to focus federal resources on the most important environmental problems where noncompliance is a significant contributing factor and where federal enforcement attention can make a difference. For the FY 2011-2013 time period, EPA’s Office of Enforcement and Compliance Assurance has six national enforcement initiatives. These initiatives are (1) Municipal Infrastructure — addressing sewage discharges from combined sewer systems, sanitary sewer systems, and municipal separate storm sewer systems; (2) Mineral Processing — addressing hazardous waste at phosphoric acid facilities and high risk mineral processing sites; (3) New Source Review — controlling emissions from coal fired utility sector, cement plants, glass plants, and acid production plants; (4) Air Toxics — addressing toxic emissions from high risk facilities by examining leak detection and repair (LDAR), flares, and excess emission sources; (5) Energy Extraction — addressing land-based natural gas extraction facilities, including corporate-wide evaluations; and (6) Concentrated Animal Feeding Operations — addressing animal waste discharges from large animal feeding facilities. In addition to these sector-based approaches, EPA could choose to focus a national initiative on a strategic area that would improve EPA’s ability to conduct its enforcement and compliance program. For example, EPA is investing in a new approach called Next Generation Compliance to improve dramatically compliance by, among other things, employing advances in emissions monitoring and information technology, and expanding transparency by making information publicly available. Comment is also solicited on new sectors or other important strategic areas for consideration. Final selection will be incorporated into the EPA Office of Enforcement and Compliance Assurance Final National Program Manager Guidance (that provides national program direction for all EPA regional offices) to be released in Spring 2013. EPA reportedly will consider these comments as it moves forward in the decision-making process, but will not respond to all comments received. Comments must be received on or before February 27, 2013.
OSHA To Review/Lookback At OSHA Chemical Standards: In a largely unnoticed entry in the Unified Regulatory Agenda issued in December, OSHA announced that it intends to review its Permissible Exposure Limits (PEL) with a view to updating them. The PELs were adopted in 1971 under Section 6(a) of the OSH Act and only a few have been successfully updated since that time. There is widespread agreement among industry, labor, and professional occupational safety and health organizations that OSHA’s PELs are outdated and need revising to take into account newer scientific data that indicate that significant occupational health risks exist at levels below OSHA’s current PELs. In 1989, OSHA issued a final standard that lowered PELS for over 200 chemicals and added PELS for 164. The final rule, however, was judicially challenged and ultimately vacated by the 11th Circuit Court of Appeals in 1991 citing deficiencies in OSHA’s analyses. Since that time OSHA has made attempts to examine its outdated PELs in light of the court’s 1991 decision. Most recently, OSHA sought input through a stakeholder meeting and web forum to discuss various approaches that might be used to address its outdated PELs. As part of the Department’s Regulatory Review and Lookback Efforts, OSHA is developing a Request for Information (RFI) seeking input from the public to help the agency identify effective ways to address occupational exposure to chemicals.
EPA Releases State Enforcement Performance Information And Comparative Maps: On February 7, 2013, EPA announced the release of state dashboards and comparative maps that provide the public with information about the performance of state and EPA enforcement and compliance programs across the country. “Transparency and access to information at all levels helps to drive improvements in environmental performance,” said Cynthia Giles, Assistant Administrator for EPA’s Office of Enforcement and Compliance Assurance. “The release of state enforcement information highlights the important work going on at the state level to address serious pollution problems and also underscores areas where states and EPA may need to strengthen enforcement and compliance efforts.” Most states and tribes in the United States have the authority to implement and enforce many of the nation’s air, water, and waste laws. The dashboards and maps include state level data from the last five years and provide information including the number of completed inspections, types of violations found, enforcement actions taken, and penalties assessed by states. To ensure data quality, EPA made the maps and dashboards available to the states in advance of this public release in order to provide an opportunity to make any necessary data corrections. Users can customize the dashboards to view state activity, EPA activity, or combined activity. Where available, the site also allows users to view national averages and display state enforcement trends over time. The interactive state performance dashboards are located on EPA’s Enforcement and Compliance History Online (ECHO) website. ECHO is an EPA transparency tool that allows the user to map federal and state inspection, violation, and enforcement information for more than 800,000 regulated facilities. The state dashboards and comparative maps that are available in ECHO are part of EPA’s commitment to increasing transparency and providing data to the public in a format that is easy to understand and use. EPA hosted two webinars demonstrating how to use the state dashboards and comparative maps now available in ECHO. The demonstration highlighted the new features added to the tool, important information about the data, and how to compare data by state. To view the state performance dashboards and comparative maps, go online. EPA’s ECHO website is available at www.epa-echo.gov.
CPSC Issues Final Rule On Phthalate-Containing Products: On February 14, 2013, the Consumer Product Safety Commission (CPSC) issued a final rule specifying what phthalate-containing product components will be determined to be “inaccessible” to children. 78 Fed. Reg. 10503. The rule is essentially unchanged from the July 2012 proposed rule except that CPSC clarified that certain mattresses and vinyl or plasticized sleep surfaces are not considered accessible through the use of removable fabric coverings. The rule is immediately effective.
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