Monthly Update for November 2013


TSCA/FIFRA/IRIS/EPCRA

IARC Nominations Of Possible Carcinogens: The International Agency for Research on Cancer (IARC) announced on October 15, 2013, that it is seeking nominations by January 31, 2014, of chemicals, occupations, biological agents, or other factors suspected of causing cancer in humans. A scientific committee will review the nominated substances or situations April 7-9, 2014, to select those that will be subject to examination to determine whether they are human carcinogens . IARC is part of the World Health Organization (WHO) and convenes advisory groups to select priority substances or situations for review. The most recent priority-setting meeting was in 2008. IARC's announcement is available online. The form to submit nominations is available online.

EPA Reschedules Chemical Assessment Meeting: On October 17, 2013, the U.S. Environmental Protection Agency (EPA) announced that it has rescheduled an October 23, 2013, public meeting to discuss five chemical assessments the Agency already is preparing or plans to prepare under its Integrated Risk Information System (IRIS) program. The assessments for all five chemicals -- ethyl tert-butyl ether (ETBE); tert-butyl alcohol (tert-butanol); hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX); ethylene oxide (EtO); and benzo[a]pyrene (BaP) -- will now be discussed during a December 12-13, 2013, meeting. The change was necessary due to the recent government shutdown. For more information, go online.

EPA Makes Available Application Checklists: On October 24, 2013, EPA posted checklists on its website identifying requirements for new pesticide registration applications. EPA noted that the checklists are designed to assist registrants in submitting applications for new pesticides to enhance efficiencies. The new checklists cover categories of conventional pesticides, antimicrobials, and biopesticides. The registration applications checklists are available online.

EPA Announces Final Rule Concerning Perfluoroalkyl Sulfonates And Long-Chain Perfluoroalkyl Carboxylate Chemical Substances: EPA issued on October 22, 2013, a final rule amending a significant new use rule (SNUR) for perfluoroalkyl sulfonate (PFAS) chemical substances. 78 Fed. Reg. 62443. The amendment adds PFAS chemical substances that have completed the Toxic Substances Control Act (TSCA) new chemical review process, but have not yet commenced production or import, and designates (for all listed PFAS chemical substances) "processing" as a significant new use. The final rule also includes a final SNUR for long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances that designates manufacturing (including importing) and processing for use as part of carpets or for treating carpet (e.g., for use in the carpet aftercare market) as a significant new use, except for use of two chemical substances as a surfactant in carpet cleaning products. For the LCPFAC SNUR, EPA is also making the article exemption at 40 C.F.R. Section 721.45(f) inapplicable to persons who import LCPFAC chemical substances as part of carpets. Persons subject to these SNURs will be required to notify EPA at least 90 days before commencing any significant new use. The required notifications will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. The final rule will be effective December 23, 2013. EPA's press release is available online. A more detailed memorandum is available online.

EPA Extends Review Period For Notices On New Chemicals Due To Federal Shutdown: On October 28, 2013, EPA announced it will extend by 16 days the deadlines for its review of various notices it receives under TSCA Section 5. 78 Fed. Reg. 64210. The notice confirms the information EPA posted on its website immediately after the federal government shutdown, which lasted from October 1 to October 16, 2013. The extension covers premanufacture notices (PMN), which companies must file prior to making or importing new chemicals ; significant new use notices (SNUN), which companies must file before they make or use a chemical in a way EPA has designated to be new ; microbial commercial activity notices (MCAN) , which companies must file before they make or import an intergeneric microorganism to use it to make chemicals ; and requests for Section 5 exemptions, which are requests to be allowed to undertake limited manufacturing activities without submitting full PMNs or similar notifications.

Center For Progressive Reform Issues TSCA Report: On October 29, 2013, the Center for Progressive Reform issued a report offering recommendations for legislation to update TSCA. The report summarizes TSCA provisions that the Center believes have made it a "dismal failure, incapable of fulfilling its role in the three-part protective framework for safeguarding the public against harmful exposures to toxic chemicals." The framework consists of federal regulations, state regulations, and the state and federal civil justice systems, stated the report. The report, "TSCA Reform: Preserving Tort and Regulatory Approaches," is available online.

Rotterdam Convention Chemical Review Panel Proposes Trade Restrictions On Three Pesticides: On October 21-25, 2013, at its meeting of the Rotterdam Convention Chemical Review Committee (CRC), a panel of scientific experts recommended imposing global trade restrictions on three pesticides considered hazardous to the environment and human health. The CRC agreed to propose adding the pesticides trichlorfon, methamidophos, and the formulation fenthion 640 ULV to the Annex III list of hazardous substances subject to prior informed consent (PIC) before shipment. The recommendations will seek final approval at a May 2015 meeting of the Conference of the Parties (COP) to the Rotterdam Convention. The Rotterdam Convention requires countries exporting chemicals or pesticides listed in its Annex III that are banned or severely restricted at home to notify the importing country and receive approval before the shipment is sent. Under Convention rules, a hazardous chemical or pesticide is to be listed in Annex III if governments in at least two regions have taken action to restrict or ban the substance and have notified the Convention of their actions.

EPA Adds Ortho-Nitrotoluene To Community Right-To-Know Toxic Chemical Release Reporting: On November 7, 2013, EPA announced it is adding ortho-nitrotoluene (o-nitrotoluene) to the list of toxic chemicals subject to reporting under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) of 1986 and Section 6607 of the Pollution Prevention Act (PPA) of 1990. 78 Fed. Reg. 66848. o-Nitrotoluene has been classified by the National Toxicology Program (NTP) in its 12th Report on Carcinogens as "reasonably anticipated to be a human carcinogen." EPA has determined that o-nitrotoluene meets the EPCRA Section 313(d)(2)(B) criteria because it can reasonably be anticipated to cause cancer in humans. The rule is effective November 29, 2013, and applies for the reporting year beginning January 1, 2014 (reports due July 1, 2015).

EPA Seeks Comment On Repellency Awareness Graphic: EPA published a notice in the November 6, 2013, Federal Register requesting comment on a repellency awareness graphic for producers of skin-applied insect repellent products to place voluntarily on repellent product labels. 78 Fed. Reg. 66698. EPA states that the graphic "is part of a voluntary, ongoing effort to enhance public health information on, and to improve the clarity of, pesticide product labeling for consumers." According to EPA, under this effort, producers can seek to use a standardized repellency awareness graphic "that will clearly communicate to consumers the estimated number of hours mosquitoes and/or ticks are repelled by a product when used as directed." EPA also seeks comment on a guidance document describing the recommended criteria and processes for companies to request voluntarily the use of this graphic. Comments are due March 6, 2014.

EPA Amends Civil Monetary Penalty Inflation Adjustment Rule: On November 6, 2013, EPA issued a final rule amending the Civil Monetary Penalty Inflation Adjustment Rule. 78 Fed. Reg. 66643. Under the Debt Collection Improvement Act of 1996 (DCIA), the rule must be adjusted for inflation certain statutory civil monetary penalties that may be assessed for violations of EPA-administered statutes and their implementing regulations. EPA is required to review the civil monetary penalties under the statutes it administers at least once every four years and to adjust such penalties as necessary for inflation according to a formula prescribed by the DCIA. EPA states that, because of the low rate of inflation since 2008, coupled with the application of the DCIA's rounding rules, only 20 of the 88 statutory civil penalty provisions implemented by EPA are being adjusted for inflation. The increased penalties will apply only to violations that occur after December 6, 2013, the effective date of the final rule. Assuming there are no changes to the mandate imposed by the DCIA, EPA intends to review all statutory penalty amounts and adjust them as necessary to account for inflation in the year 2017 and every four years thereafter.

EPA Schedules TSCA Risk Assessment: On November 8, 2013, EPA announced that its Scientific Consulting Group, Inc. (SCG) has identified a panel of scientific experts to conduct a peer review of EPA's draft TSCA chemical risk assessment, "TSCA Workplan Chemical Risk Assessment for HHCB." 78 Fed. Reg. 67142. EPA will hold three peer review meetings by web connect and teleconference. The public may provide comment on whether they believe the appearance of conflict of interest exists for any proposed peer review panel expert. The peer review meetings will be held on Wednesday, December 4, 2013, from 12:00-2:00 p.m. (EST); Thursday, January 9, 2014, from 10:30 a.m.-3:30 p.m. (EST); and Thursday, February 6, 2014, from 10:30 a.m.-12:30 p.m. (EST).

Efforts To Implement NAS Report Recommendations On Ecological Risk Assessment For Endangered And Threatened Species: On November 13, 2013, EPA and the U.S. Fish and Wildlife Service, the National Oceanic and Atmospheric Administration's National Marine Fisheries Service, and the U.S. Department of Agriculture released a white paper entitled Interim Approaches for National-Level Pesticide Endangered Species Act Assessments Based on the Recommendations of the National Academy of Sciences April 2013 Report. In 2011, the agencies requested that the National Academy of Sciences (NAS) convene a committee to examine topics pertaining to tools and approaches for assessing the effects of proposed Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) actions on endangered and threatened species and their critical habitats. NAS released its report, which is available online, in April 2013. Since then, the agencies have been working to develop shared scientific approaches that reflect the advice provided by NAS. The white paper states that the agencies have developed joint interim scientific approaches for assessing the risks of pesticides to endangered and threatened species, based on the NAS recommendations. The agencies are also working on increasing the opportunities for stakeholder input during the review of pesticide registrations under FIFRA and associated consultations under the Endangered Species Act (ESA). The white paper states that the interim approaches for the consultation process, which are based on shared assumptions, data, analytical processes, and models, will be applied collaboratively as part of EPA's Registration Review Program beginning in 2014. The agencies will generally use a three-step consultation process: -- Step 1 ("No Effect/May Affect" determination); Step 2 ("Not Likely to Adversely Affect (NLAA)/Likely to Adversely Affect (LAA)" determination); and Step 3 ("Jeopardy/No Jeopardy" determination and "adverse modification/no adverse modification" determination on effects to designated critical habitat(s)) -- with the understanding that the data and analyses for each step will be used, when possible, for the subsequent steps. The white paper is available online.

RCRA

EPA Releases Update V To RCRA Test Methods Compendium: EPA on October 23, 2013, released Update V to the third edition of EPA publication SW-846, Test Methods for Evaluating Solid Waste, Physical/Chemical Methods. 78 Fed. Reg. 63185. SW-846 is EPA's official compendium of analytical and sampling methods that EPA has evaluated and approved for use in complying with the Resource Conservation and Recovery Act (RCRA) regulations. SW-846 functions primarily as a guidance document setting forth acceptable, although not required, methods for the regulated and regulatory communities to use in responding to RCRA-related sampling and analysis requirements. Update V to SW-846 contains 23 new and revised analytical methods. It also revises quality assurance/quality control (QA/QC) guidance on lower limit of quantitation (LLOQ), relative standard error, and initial demonstration of proficiency. EPA is accepting comments on Update V until January 21, 2014.

Court Orders EPA To Submit RCRA Coal Ash Update Within 60 Days: The U.S. District Court for the D.C. Circuit on October 29, 2013, gave EPA just 60 days to submit to the court an update on its pending RCRA rule for managing coal ash residues. The order also calls for EPA to provide a schedule for when it will promulgate the rule in final. The ruling comes on the heels of a previous decision by the court that EPA has a statutory mandate to issue the RCRA ash regulation. The impacts of the coal ash rule and litigation aside, when taken in tandem, the court's two orders could alter the landscape of future RCRA regulation. The rulings support arguments that RCRA provisions regarding EPA's periodic review and updating of regulations are mandatory and not discretionary EPA actions. RCRA Section 2002(b), for example, requires EPA to review, and if necessary, revise its regulations regarding coal ash every three years, deadlines EPA has failed to meet. The order concludes that Section 2002(b) "creates a non-discretionary duty" and that EPA's failure to meet such obligations exposes it to RCRA citizen suits. RCRA contains similar provisions regarding the regular review and necessary revision of other pillars of the regulatory program, such as the Toxicity Characteristic. The court's decisions could prompt additional actions by parties seeking to compel EPA to update its RCRA regulatory program.

Proposed Tier 2 Endocrine Tests Not Ready For Screening Program: In a report released on October 23, 2013, EPA's Scientific Advisory Panel (SAP) concluded that the four ecotoxicity tests proposed for inclusion in EPA's Endocrine Disruptor Screening Program (EDSP) are not ready for use in assessing a chemical's effects on the endocrine system. The report, dated September 27, 2013, notes that the proposed tests are not yet repeatable and transferable due to inter-laboratory variability in test results. The SAP, which advises EPA on issues related to FIFRA, identified flaws in the experimental design and statistical analyses of the four studies, a lack of clarity in the protocol for conducting the tests and a need for additional reference chemicals. The SAP recommended that EPA develop a multi-generation avian reproduction test as a supplement to the Japanese quail two-generation toxicity test . The panel recommended that EPA use the zebra finch, a passerine bird, as the test species. Other specific recommendations were offered. The SAP report on Tier 2 endocrine testing is available online.

ALJ Affirms EPA's Claim That Chemical Company Failed To Disclose Public Health Risks: On November 12, 2013, Elementis Chromium, Inc. was ordered to pay a penalty of $2,571,800 for failing to disclose information about substantial risk of injury to human health from exposure to hexavalent chromium as required by TSCA Section 8(e). TSCA requires chemical manufacturers, processors, or distributors that obtain information demonstrating that a substance or mixture presents a substantial risk of injury to human health or the environment immediately inform EPA. In September 2010, EPA filed a complaint against Elementis with the Office of Administrative Law Judges, alleging TSCA violations for failing to report the results of an industry-commissioned study that documented, according to EPA, significant occupational impacts to workers in modern chemical plants. According to EPA, the study filled a gap in scientific literature regarding the relationship between hexavalent chromium exposure and respiratory cancer in modern chromium production facilities. Chief Administrative Law Judge (ALJ) Susan Biro held an administrative hearing in December 2011, where both sides presented expert witnesses and additional evidence. Judge Biro issued a decision and assessed a penalty, concluding that Elementis had violated TSCA. This decision will become a final order 45 days following issuance unless the company chooses to appeal the decision to EPA's Environmental Appeals Board.

GREEN CHEMISTRY

BizNGO Issues Principles For Alternatives Assessment: On October 17, 2013, the Environmental Defense Fund Inc. (EDF) announced together with BizNGO, the Toxic Use Reduction Institute, and the Lowell Center for Sustainability released The Commons Principles for Alternatives Assessment, reported with the support of over 100 representatives of business, universities, and non-governmental organizations (NGO). According to the statement, alternatives assessment is "a process for identifying, comparing, and selecting safer alternatives to chemicals of concern based on certain chemical features including hazard, performance, and economics." The six "Common Principles" establish key elements of informed decision-making about the chemicals in a product. They are: reduce hazard, minimize exposure, use best available information, require disclosure and transparency, resolve trade-offs, and take action. More information is available online.

NANOTECHNOLOGY

Sweden Proposes National Action Plan For Nanomaterials: On October 8, 2013, Sweden issued a report proposing a national action plan for the safe use and management of nanomaterials. The report's recommendations, as described in the English summary, include specific actions within several categories. Of particular interest are the following categories and specific recommendations:

  • Measures for the development of the European Union's (EU) regulatory framework:
    • The government and relevant agencies shall work to bring about a revision of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH):
      • Nanomaterials are to be registered as a separate substance;
         
      • The tonnage limits are reduced for nanomaterials;
         
      • The information to be submitted when registering nanomaterials includes supplementary data on their physic-chemical properties and, when necessary, other relevant information;
         
      • The obligation to register products containing nanomaterials is extended; and
         
      • The rules regarding information to downstream users are to be revised so that they also include relevant details on nanomaterials.
         
    • The government and relevant agencies shall work to bring about a revision of the European legislation on chemical substances and products:
      • The regulatory frameworks ensure that the data submitted and the assessments made are relevant to the substance in the form it occurs.
         
    • Manufacturers, importers, and distributors of products containing nanomaterials should be able to declare the preceding and subsequent links in the distribution chain.
       
    • The proposed amendments to the regulation on novel foods, aimed at clarifying the regulations on nanomaterials, are to be adopted as soon as possible.
       
  • Measures to increase knowledge about nanomaterials on the market:
    • The Swedish Chemicals Agency to be given the task of investigating how an obligation to submit information on the occurrence of nanomaterials when registering products in the product register might be worded.
       
    • An inventory of products on the market that contain nanomaterials to be performed.

Particle And Fibre Toxicology Publishes Article Concerning Workplace Exposure To CNTs: On October 21, 2013, Particle and Fibre Toxicology posted an article entitled "Carbon nanotube dosimetry: from workplace exposure assessment to inhalation toxicology." The authors, who are affiliated with the National Institute for Occupational Safety and Health (NIOSH), note that there are currently no known end-point effects in humans following carbon nanotube (CNT) exposure, leading to extrapolation from rodent studies. The purpose of the study was to determine how realistic U.S. workplace exposures to CNTs relate to animal studies. The study states that its goal "was to expose animals to a high dose that would cause significant inflammation with histological findings and then a low dose to serve as a no observable effect level. This design will serve as a reference for detailed molecular analysis, pulmonary pathology, systemic inflammation, and evaluation of cardiovascular dysfunction at human relevant exposures." The abstract states that the findings "showed a limited pulmonary inflammatory potential of MWCNT at levels corresponding to the average inhalable elemental carbon concentrations observed in U.S.-based CNT facilities and estimates suggest considerable years of exposure are necessary for significant pathology to occur at that level." The conclusion itself states: "It is clear from toxicological evaluations that MWCNT have a relatively high hazard when compared to other materials. These hazards may include fibrosis, promotion of lung tumors, cardiovascular dysfunction, and pulmonary and systemic inflammation. The present findings show that limiting cumulative exposures is imperative to reducing adverse effects." The abstract is available online.

FDA Finds Current Regulatory Review Processes Protect Public From Risks Of Nanomaterials: The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) posted a blog item on October 24, 2013, concerning the use of nanotechnology to develop new drugs. According to the item, "[t]here are already many products made using materials at the nanoscale, including new kinds of clothing, packaging materials, and light-weight, but strong, building materials." CDER conducted a series of risk assessment and risk management exercises concerning drugs that contain nanomaterials to determine if its current regulatory processes are adequate to identify any potential risks and reduce those risks. CDER states that these exercises "determined that our current regulatory review processes indeed can adequately protect the public from potential risks associated with the use of nanomaterials in drug products." CDER also identified areas that could benefit from improvement, including "increased nanotechnology regulatory science research and up-to-date training of the review staff who evaluate marketing applications for drug products developed using nanomaterials." FDA will present the findings of these exercises at the January 14-15, 2014, workshop on "Nanomaterial Drug Products: Current Experience and Management of Potential Risks." FDA's blog item is available online. More information regarding the January 2014 workshop is available online.

Wilson Center Announces Updated Nanotechnology Consumer Products Inventory: On October 28, 2013, the Wilson Center announced that the updated Nanotechnology Consumer Products Inventory contains 1,628 consumer products that have been introduced to the market since 2005, which is a 24 percent increase since the last update in 2010. The Wilson Center states that the re-launched inventory "seeks to address scientific uncertainty with contributions from those involved with nanomaterials production, use, and analysis." The Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars created the inventory in 2005. Together with the Virginia Tech Center for Sustainable Nanotechnology, the Wilson Center redeveloped the inventory, and Virginia Tech's Institute for Critical Technology and Applied Science provided funding. The Wilson Center states that the re-launched inventory "seeks to 'crowdsource' expertise in an effort to create an inventory with more accurate information on consumer products." It encourages users to register and submit "relevant data pertaining to nanoparticle function, location, and properties; potential exposure pathways; toxicity; and lifecycle assessment, as well as add product data and information on new products." The October 28, 2013, announcement is available online. The inventory is available online.

WHO Meeting Report States Precautionary Approach Towards Nanomaterials "Seems Desirable": WHO recently published the report of the December 10-11, 2012, WHO expert meeting entitled Nanotechnology and human health: Scientific evidence and risk governance. The conclusion states that while "first generation nanomaterials are being used in a variety of applications and products, they do not seem to present an imminent public health issue." The conclusion continues, however, and states: "Given the scientific uncertainty and still emerging evidence, and given the early indications of harm and possible adverse human health effects that have been hypothesised for some nanomaterials, a precautionary approach seems desirable." The report notes the need for data concerning nanoparticle exposure and distribution in the human body, toxicological mechanisms, and possible adverse health effects. According to the report, available methodology, current protocols, and testing guidelines for chemical risk assessment could be used to assess nanomaterials, "but they need adaptation." The report recommends that further initiatives "be undertaken to use available evidence on health implications, to the extent possible, to inform the risk governance of nanotechnology." The report is available online.

Court Partially Vacates And Remands EPA's Decision Granting Conditional Registrations For HeiQ's Nanosilver Products: On November 7, 2013, a panel of the U.S. Court of Appeals for the Ninth Circuit issued a decision granting in part and denying in part the Natural Resources Defense Council's (NRDC) petition for review of the EPA conditional registration of HeiQ AGS-20 and AGS-20 U (collectively, AGS-20) pesticide products that EPA has determined contain nanoscale silver (nanosilver). The court vacated EPA's decision "insofar as it concluded that there was no risk concern requiring mitigation for short- and intermediate-term aggregate oral and dermal exposure to textiles that are surface-coated with AGS-20." The opinion by a majority of the appellate panel based this holding solely on EPA's failure to require risk mitigation after calculating a margin of exposure (MOE) for aggregate exposure to AGS-20 of exactly 1,000, and stated that this holding has no effect on "any portion of EPA's decision where the calculated MOE is greater than 1,000." The majority opinion also denied NRDC's other objections to the registration decision, holding that substantial evidence supported EPA's decision to use the characteristics of toddlers rather than infants in its risk assessment for AGS-20, as well as EPA's decision not to consider other sources of exposure to nanosilver in its risk assessment. In a dissenting opinion, one member of the panel disagreed with the decision by the majority to deny these other objections. The decision is available online. A more detailed memorandum is available online.

NIOSH Issues New Recommendations To Control Worker Exposure To Engineered Nanomaterials: On November 8, 2013, NIOSH published a report entitled Current Strategies for Engineering Controls in Nanomaterial Production and Downstream Handling Processes, which identifies and describes strategies for the engineering control of worker exposure during the production or use of engineered nanomaterials. NIOSH notes that there are currently more than 1,000 nanomaterial-containing consumer products available, including "makeup, sunscreen, food storage products, appliances, clothing, electronics, computers, sporting goods, and coatings." According to the report, hazards involved in manufacturing and processing nanomaterials "should be managed as part of a comprehensive occupational safety, health, and environmental management plan." NIOSH states: "Engineering controls are favored over administrative controls and personal protective equipment for lowering worker exposures, because they are designed to remove the hazard at the source, before it comes into contact with the worker." The report includes specific conclusions and recommendations on the following topics: general; control banding; hierarchy of controls; engineering controls; administrative controls; and personal protective equipment. The report is available online.

A&WMA Seeks Authors, Presenters, And Panelists For June 2014 Conference: The Air & Waste Management Association (A&WMA) is currently seeking authors, presenters, and panelists for its 107th Annual Conference and Exhibition, which will be held June 24-27, 2014, in Long Beach, California. The A&WMA Intercommittee Task Force (ITF) on Nanoscale Science and Engineering is sponsoring a track in the technical program that will span a wide array of subjects, including environmental policy, measurement, health effects, monitoring, management, and safety issues associated with the development and use of nanomaterials, nanotechnologies, and nanoscale products. More information is available online.

CERCLA

EPA Releases Draft Groundwater Cleanup Strategy: EPA on October 29, 2013, released and is seeking comment upon a draft Groundwater Remedy Completion Strategy. According to EPA, the draft strategy "describes a recommended, step-wise plan and decision-making process for evaluating remedy operation, progress and attainment of remedial action objectives (RAOs) using an updated conceptual site model, performance metrics, and site-specific data." Comments should be sent by December 20, 2013, to gwcompletionstrategy@epa.gov.

BIOBASED/RENEWABLE PRODUCTS

BRAG™ Biobased Products News And Policy Report: Bergeson & Campbell, P.C.'s consulting affiliate, B&C® Consortia Management, L.L.C., manages the Biobased and Renewable Products Advocacy Group (BRAG™). For access to a weekly summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to www.braginfo.org.

EPA Releases Proposed 2014 RFS Rule And Requests Comment On RFS Waiver Requests: On Friday, November 15, 2013, EPA released its long-awaited and much anticipated Notice of Proposed Rulemaking (NPRM) to set the 2014 renewable volume obligations (RVO) under the federal Renewable Fuel Standard (RFS). Simultaneously, EPA issued a request for comment on several petitions it has received from The American Petroleum Institute (API), American Fuel and Petrochemical Manufacturers (AFPM), and individual obligated parties requesting EPA grant a partial waiver of the 2014 RFS statutory RVOs. Once the NPRM and request for comment are formally published in the Federal Register, there will be a 60-day comment period for both. These two documents are available in pre-publication form online.

The NPRM appears to be similar to the draft of it that was leaked publicly last month. It marks a shift in EPA's implementation of the RFS, as it proposes to reduce the overall and advanced RVOs, in addition to the cellulosic RVOs. EPA cites blend wall concerns for the proposed overall and advanced reductions. EPA proposes to maintain the 2013 RVOs for biodiesel in both 2014 and 2015 at a level of 1.28 billion gallons. The advanced, cellulosic, and total renewable RVO gallons contained in the RFS statute for 2014 are: 3.75 billion for advanced, 1.75 billion for cellulosic, and 18.15 for total renewable fuel (the RVO for corn starch ethanol is this number minus those for advanced, cellulosic, and biodiesel). The proposed RVO gallons for 2014 are: 2.2 billion for advanced, 17 million for cellulosic, and 15.21 billion for total renewable.

LEGISLATIVE DEVELOPMENTS

House Passes Water Resources Reform And Development Act Of 2013: In an increasingly rare show of bipartisanship, the House of Representatives on October 23, 2013, overwhelmingly passed the Water Resources Reform and Development Act of 2013 (H.R. 3080) on a 417-3 vote. The bill now heads to a House-Senate conference to be reconciled with the Senate-passed Water Resources Development Act of 2013 (S. 601). The bill is intended to streamline projects under the Water Resources Development Act (WRDA). It would do so primarily by making the U.S. Army Corps of Engineers (the Corps) the lead decision-maker in many projects. Specifically, the bill would amend the WRDA of 1986 to: (1) limit the duration of any feasibility study to three years; (2) limit the cost of any such study to $3 million; and (3) require personnel of the Corps to conduct concurrent reviews of feasibility studies (currently, sequential reviews are permitted). It also requires the Secretary of the Army, not later than 90 days after the initiation of a feasibility study, to initiate federally-mandated reviews, including environmental reviews. Under the bill, the Corps would be designated as the federal lead agency in the environmental review process. This means the Corps, rather than EPA, would take the lead in preparing environmental impact statements, environmental assessments, categorical exclusions, or other documents required under the National Environmental Policy Act of 1969 (NEPA) for a water resources project study. The bill also authorizes funds to improve ports and inland waterways.

House Committee Passes Bills To Exempt Certain Pesticide Applications From NPDES Permitting Requirements: The House Transportation and Infrastructure Committee on October 29, 2013, approved two bills that would exempt two common activities from the requirement to obtain National Pollutant Discharge and Elimination System (NPDES) permits under the Clean Water Act (CWA). The Reducing Regulatory Burdens Act of 2013 (H.R. 935) would exempt pesticide spraying operations near or at waters from NPDES permitting, if the pesticides are already registered under FIFRA. The Silviculture Regulatory Consistency Act of 2013 (H.R. 2026) would exempt stormwater discharges from logging roads and operations from the requirement to obtain NPDES permits. The bills now move to the full House for consideration.

House Committee Holds Hearing On Carbon Capture And Sequestration Technology: The House Science, Space, and Technology (SST) Subcommittees on the Environment and Energy on October 29, 2013, held a joint hearing to explore the technological basis for concluding that carbon capture and sequestration (CCS) is adequately demonstrated as a technology for controlling carbon dioxide (CO2) emissions in full-scale commercial power plants. Witnesses discussed and debated EPA's assessment that CCS has been "adequately demonstrated." EPA recently announced it is moving forward with proposed New Source Performance Standards (NSPS) for emissions of CO2 from coal-fired power plants. Studies have verified that implementation of CCS technology will be necessary to comply with the proposed CO2 targets set forth in the rule. The hearing witnesses generally agreed that CCS technology is not ready, including a former Obama Administration energy official. The witness list, testimonies, and related information are available online.

Critical Minerals Policy Act Of 2013 Introduced In Senate: On October 29, 2013, 15 Senators introduced bipartisan legislation intended to ensure access to critical minerals the U.S. needs for energy and other industries. The Critical Minerals Policy Act of 2013 directs the Secretary of the Interior to create a critical minerals list. It also requires the Department of Energy (DOE) to establish a research and development program on the efficient production, use, and recycling of critical minerals.

House Republicans Ask EPA To Submit CWA Jurisdiction Rule To Science Advisory Board: In a letter to EPA Administrator Gina McCarthy, Representative Lamar Smith (R-TX), Chair of the House SST Committee, and Representative Chris Stewart (R-UT), Chair of the SST Subcommittee on Environment, asked that EPA forward its draft regulation establishing jurisdiction under the CWA to the Science Advisory Board (SAB) for review. The draft proposed rule seeks to clarify the scope of water bodies that would fall under the authority of EPA and the Corps when those agencies seek to designate or regulate wetlands. "It is widely anticipated that in its upcoming proposal, EPA intends to expand federal regulatory authority under the Clean Water Act to include even the most isolated wetlands, seasonal drainages, and prairie depressions," the letter stated. "A sweeping reinterpretation of EPA jurisdiction would give the agency unprecedented control over private property across the nation." Smith and Steward stated that the SAB had been given a scientific report about how upstream waterways are connected to downstream waterways, and that to study the issue comprehensively, the SAB would need the draft rule. "Without a draft copy of the draft rule, the Members of the Panel for the Review of the Connectivity Report cannot meaningfully review this regulatory science in context," the letter states.

House Appropriations Committee Announces New Subcommittee Chairs: House Appropriations Committee Chair Hal Rogers (R-KY) on November 13, 2013, announced the selection of four new Subcommittee Chairs, including the Subcommittee that oversees EPA's budget. Representative Mike Simpson (R-ID) will chair the Energy and Water Development and Related Agencies Subcommittee, which has primary jurisdiction over establishing EPA's budget in the House.

MISCELLANEOUS

Inspector General Urges EPA To Gauge Utility Of Watch List: In a recent report entitled The EPA Should Assess the Utility of the Watch List as a Management Tool, EPA's Inspector General asks EPA to assess the utility of the "Watch List" by September 30, 2014. EPA developed the tool in 2004 to ensure enforcement of the Clean Air Act (CAA), the CWA, and RCRA. The Inspector General found use of the tool varied among state and regional offices and concluded the data quality of entries was unreliable. The Inspector General's report is available online.

OSHA Announces Resources Intended To Protect Workers From Hazardous Chemicals: The Occupational Safety and Health Administration (OSHA) announced on October 24, 2013, two web resources intended "to assist companies with keeping their workers safe." OSHA states that its exposure standards "are out-of-date and inadequately protective for the small number of chemicals that are regulated in the workplace." OSHA has created a toolkit to identify safer chemicals that can be used in place of more hazardous ones. The toolkit walks employers and workers step-by-step through information, methods, tools, and guidance either to eliminate hazardous chemicals or make informed substitution decisions in the workplace by finding a safer chemical, material, product, or process. The toolkit is available online. OSHA also created another new web resource, annotated permissible exposure limit (PEL) tables, that "will enable employers to voluntarily adopt newer, more protective workplace exposure limits." OSHA states that, since adopting the majority of its PELs more than 40 years ago, "new scientific data, industrial experience and developments in technology clearly indicate that in many instances these mandatory limits are not sufficiently protective of workers' health." The annotated PEL tables provide a side-by-side comparison of OSHA PELs for general industry to the California Division of Occupational Safety and Health (Cal/OSHA) PELs, NIOSH recommended exposure limits (REL), and American Conference of Governmental Industrial Hygienist (ACGIH) threshold limit values (TLV). The annotated PEL tables are available online. More information is available online.

FTC Gets Tough On Green Guides And "Cracks Down" On Misleading And Unsubstantiated Environmental Marketing Claims: On October 29, 2013, the Federal Trade Commission (FTC) announced six enforcement actions concerning misleading and unsubstantiated environmental marketing claims. In a case imposing a $450,000 civil penalty, FTC filed a complaint and consent order against a company for violating a 1994 FTC order prohibiting it from making unsupported green claims for its paper plates and bags. In the five other actions, FTC addressed biodegradable plastic claims for the first time. In one case, FTC filed a complaint against a company for marketing an additive that it claims makes plastic products biodegradable. In the other four cases, FTC announced complaints and proposed consent orders against companies that marketed various plastics with allegedly false and unsupported claims that their products were biodegradable. More information is available online. These cases are in addition to recent settlements with paint manufacturers and mattress manufacturers regarding claims their products were free of volatile organic compounds (VOC). As discussed below, all these cases, and the related guidance documents that FTC has issued, telegraph to the business community FTC's keen interest in ensuring compliance with FTC's recently revised Guides for the Use of Environmental Marketing Claims. A more detailed memorandum is available online.

OSHA Proposes Changes To Injury And Illness Recordkeeping And Reporting Requirements: On November 8, 2013, OSHA issued a proposed rule intended to improve workplace safety and health through improved tracking of workplace injuries and illnesses. 78 Fed. Reg. 67254. OSHA stated that the proposed rule would require employers to report "useful, accessible, establishment-specific injury and illness data" to which it currently does not have "direct, timely and systematic access." The announcement follows the Bureau of Labor Statistics' release of its annual Occupational Injuries and Illnesses report, which estimates that three million workers were injured on the job in 2012. OSHA believes that timely, establishment-specific injury and illness data will help OSHA target its compliance assistance and enforcement resources more effectively by identifying workplaces where workers are at greater risk, and enable employers to compare their injury rates with others in the same industry. OSHA developed the proposed rule following a series of stakeholder meetings in 2010 to help collect information about electronic submission of establishment-specific injury and illness data. OSHA is proposing to amend its current recordkeeping regulations to add requirements for the electronic submission of injury and illness information employers are already required to keep under existing standards. Under the proposal, establishments with more than 250 employees (and who are already required to keep records) would be required to submit the records electronically on a quarterly basis to OSHA. OSHA is also proposing that establishments with 20 or more employees, in certain industries with high injury and illness rates, be required to submit electronically only their summary of work-related injuries and illnesses to OSHA once a year. Currently, many such firms report this information under OSHA's Data Initiative. OSHA plans to post eventually the data online. Comments on the proposed rule are due by February 6, 2014.

EPA Associate Administrator For Policy Moves To DOE: EPA recently announced that Associate Administrator for Policy, Michael Goo, will leave EPA and move to DOE. Shannon Kenny, the Office of Policy's Principal Deputy Associate Administrator, will assume the role of Acting Associate Administrator.

Canada Publishes Order Designating PFOA, Long-chain PFCAs As Toxic: On November 6, 2013, the Canadian government published a final order designating perfluorooctanoic acid (PFOA) and long-chain perfluorocarboxylic acids (PFCA) as toxic. The addition of PFOA, long-chain PFCAs, their salts, and their precursors to Schedule I of the Canadian Environmental Protection Act (CEPA) allows the government to regulate the substances to manage their environmental risks, Environment Canada and Health Canada stated. Regulatory instruments are to be proposed by August 25, 2014, and issued in final by February 25, 2016. The final order is available online.

Obama Names New Climate Change Advisor: The White House on November 8, 2013, announced that Dan Utech will become President Obama's top advisor on energy and climate change. Utech currently serves as the Deputy Director for climate at the White House; he joined the Administration in 2010 and will replace current energy and climate czar Heather Zichal. Utech is widely considered a seasoned hand on climate and energy issues and is anticipated to continue a steady hand on Obama's climate change agenda. Prior to joining the Administration, Utech was a staffer on the Senate Environmental and Public Works Committee and spent five years as then-Senator Hillary Clinton's (D-NY) top advisor on energy and environment issues.

EPA Inspector General Announces Review Of Design For The Environmental Program: On November 6, 2013, EPA's Inspector General announced it will review the Design for the Environment (DfE) Safer Product Labeling Program. In a memorandum dated March 2013, the Office of Inspector General advised EPA that it will review the program to determine how effectively DfE labels are at highlighting safer products. The DfE program seeks to identify consumer products that use the safest possible chemical ingredients. The DfE label indicates that a product has undergone a rigorous review to ensure that it meets both stringent safety criteria and high efficacy standards, according to EPA's website on the DfE program. The EPA Inspector General's memorandum is available online.

Obama Nominates Johns Hopkins Associate Dean To Head EPA Research, Development Office: On November 7, 2013, President Barack Obama nominated Thomas A. Burke, Associate Dean for Public Health Practice and Training at the Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland, to serve as EPA Assistant Administrator for Research and Development. Burke works in both the Department of Environmental Health Sciences and the School of Medicine at Johns Hopkins, according to information from EPA. Burke also directs the Johns Hopkins Risk Sciences and Public Policy Institute. Burke has served as Chairman of the NAS Committee on Improving Risk Analysis, and he is a member of the EPA's Chartered SAB, which oversees SAB's many committees. Burke served as Deputy Commissioner for the New Jersey Department of Health from 1986 to 1990 and previously served as the Assistant Commissioner.

NIOSH Seeks Comment On Draft Update Of NIOSH Carcinogen Classification And Target Risk Level Policy For Chemical Hazards In The Workplace: NIOSH announced on November 15, 2013, the availability of a draft document for public comment entitled Current Intelligence Bulletin: Update of NIOSH Carcinogen Classification and Target Risk Level Policy for Chemical Hazards in the Workplace. 78 Fed. Reg. 68849. The draft document updates the NIOSH carcinogen classification and relevant REL policies. According to NIOSH, the proposed update is prompted by comments from the public and stakeholders and recent developments in how the carcinogenic risk to substances is assessed. NIOSH states that its stakeholders have recently expressed concerns about limitations in the NIOSH approach to classifying and controlling carcinogens. One significant limitation is use of the term "Potential Occupational Carcinogen," which dates to the OSHA hazard classification for carcinogens outlined in 29 C.F.R. Section 1990.103. NIOSH states: "The adjective 'potential' conveys uncertainty that is not warranted with many carcinogens such as asbestos, benzene, and others." NIOSH notes that its existing NIOSH carcinogen policy does not allow for classification on the basis of the magnitude and sufficiency of the scientific evidence. In contrast, other organizations such as NTP, IARC, and EPA have differential classification systems with categories that reflect the weight of scientific evidence. NIOSH will hold a public meeting on the draft document on December 16, 2013. Comments on the draft document are due February 13, 2014. More information is available online.

This Update is provided as a complimentary service to our clients and is for informational purposes. This Update may be copied or quoted, provided proper attribution is given. The contents are not intended and cannot be considered as legal advice.

 
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